2016 ipi advisor manual - minnesota dept. of health
TRANSCRIPT
2017 IPI Advisor Manual
A Guide to MnVFC Site Visits
MINNESOTA VACCINES FOR CHILDREN PROGRAM
Table of Contents
Introduction 3
Welcome to the Immunization Practice Improvement (IPI) ProgramHelpful DefinitionsContact Information
Chapter 1 The Immunization Practices Improvement Program5
Vaccines for Children ProgramRequirements to Participate in the MnVFC Program
Chapter 2 IPI Advisors7
Your Role as an IPI Advisor New IPI Advisor Training Requirements Your MnVFC Clinical CoordinatorPlanner Types of Visits Reimbursement for MnVFC VisitsReasons MDH Would Do All or Part of a Visit
Chapter 3 Site Visits11
Scheduling the Visit Site Visit Checklist Information for the VisitPreparing for the VisitConducting the VisitFuture follow-up
Chapter 4 The 2017 MnVFC Site Visit Paperwork 17
Required Paperwork for Site VisitsMnVFC Site Visit QuestionnaireThe Site Visit Reviewer LegendSection 1 Provider DetailsSection 2 EligibilitySection 3 DocumentationSection 4 Storage amp Handling Per UnitSection 5 Storage amp Handling Site-WideSection 6 Inventory MnVFC Site Visit Storage and Handling Per Unit Answer SheetMnVFC Provider Follow-up PlanAfter the Site Visit
Chapter 5 IPI Advisor Resource List 52
Introduction
Welcome to the Immunization Practice Improvement (IPI) Program IPI is a component of the immunization program at the Minnesota Department of Health IPI merges key aspects of the overall immunization program at the provider level vaccine management vaccine accountability and clinical immunization practices
As an IPI advisor you will be conducting visits to sites that provide vaccines to children through the Minnesota Vaccines for Children (MnVFC) program
This manual along with the appropriate MnVFC Policies and Procedures Manual for the type of site you are visiting will provide you with the information that you need to complete these visits
The most up to date version of this manual is available on the IPI Program Resources (wwwhealth statemnusdivsidepcimmunizeipiresourceshtml) website Changes and additions will be included as they occur
By performing site visits you help ensure that children in Minnesota receive safe viable immunizations and are protected from vaccine-preventable diseases Thank you
Helpful Definitions Sites In this manual all organizations that administer vaccine to MnVFC-eligible children andor store vaccine for MnVFC-eligible children will be referred to as sites
Separate stock Method of vaccine management where sites keep privately-purchased vaccine in a separate stock from MnVFC vaccine obtained through MDH Patients eligible for MnVFC must receive vaccine from the MnVFC stock
Replacement method Method of vaccine management where sites use privately-purchased vaccine to vaccinate MnVFC-eligible children and then the MnVFC program replaces the private vaccine that was administered Only sites with grandfathered status and who have a signed replacement method agreement are allowed to use the replacement method
Parent site A parent site is a location where vaccine is ordered and delivered to be redistributed to satellite sites It is based on how the system is set up for ordering vaccine in the MnVFC ordering software This may or may not be how the site is structured as an organization The parent site orders all the vaccines for the other sites except for varicella-containing vaccines Varicella-containing vaccine must be delivered directly to the site where it will be used The parent site is responsible for the MnVFC Annual Report for itself and all of its satellite sites
Satellite site A satellite site is a site that receives redistributed vaccine from a parent site All satellite sites need to have an enrollment visit and a PIN number to receive MnVFC vaccine from the parent site Sites that are considered a satellite of another site usually have a letter at the end of the PIN to indicate that they are a satellite All vaccines except varicella-containing vaccines are ordered by the parent site for the satellite site Varicella-containing vaccines are ordered using the satellite PIN and are delivered directly to the satellite site Sites must sign a separate provider agreement for each satellite site that stores MnVFC vaccine
IPI Advisor Manual | February 2017 Page 3
Introduction cont
Federally Qualified Health Center (FQHC) A site that is located in an area of need of services Sites apply to receive this federal designation They offer a sliding scale for patients that are uninsured
Rural Health Center (RHC) A site that is located in an underserved rural area They apply to receive this federal designation
Local Public Health (LPH) Clinics are deputized in Minnesota to allow vaccination of underinsured children at their site
Contact Information Immunization Practices Improvement (IPI)
Email healthIPIinquiriesstatemnus
Website wwwhealthstatemnusdivsidepcimmunizeipiindexhtml
Minnesota Vaccine for Children (MnVFC) Program
Phone 651-201-5522
Website wwwhealthstatemnusvfc
Minnesota Department of Health 625 N Robert St (street address) PO Box 64975 (mailing address)St Paul MN 55164-0975
Page 4 IPI Advisor Manual | February 2017
Chapter 1
The Immunization Practices Improvement Program The goal of the Immunization Practices Improvement (IPI) Program is to help ensure that all eligible children receive viable vaccine at low or no cost
The Minnesota Department of Health (MDH) contracts with local public health departments to provide IPI services in their community IPI advisors from these departments complete site visits at MnVFC- enrolled sites in their county Local public health (LPH) staff often already have a relationship with primary care providers in their community and if not visits may help facilitate building relationships and sharing information Visits ensure enrolled sites meet the following objectives
bull Adhere to MnVFC eligibility and programmatic requirements and recommendations bull Manage vaccines to ensure proper storage and handling and minimize waste bull Administer and document vaccines according to current immunization guidelines
Vaccines for Children Program The Vaccines for Children (VFC) Program is a federal entitlement program which provides vaccines to children whose parents or guardians may not be able to afford them This helps ensure that all children have a better chance of getting their recommended vaccinations on schedule Vaccines available through the VFC Program are those recommended by the Advisory Committee on Immunization Practices (ACIP) (wwwcdcgovvaccinesacipindexhtml) These vaccines protect babies young children and adolescents from 16 diseases
Funding for the VFC program is approved by the Office of Management and Budget (OMB) and allocated through the Centers for Medicare amp Medicaid Services (CMS) to the Centers for Disease Control and Prevention (CDC) CDC buys vaccines at a discount and distributes it to grantees (ie state health departments) who then distribute the vaccine at no charge to enrolled sites
History of the Vaccines for Children Program
From 1989 - 1991 a measles epidemic in the United States resulted in tens of thousands of cases of measles and hundreds of deaths Upon investigation CDC found that more than half of the children who had measles had not been immunized even though many of them had seen a health care provider
In partial response to that epidemic Congress passed the Omnibus Budget Reconciliation Act (OBRA) on Aug 10 1993 creating the Vaccines for Children (VFC) Program VFC became operational Oct 1 1994 Known as section 1928 of the Social Security Act the VFC Program is an entitlement program (a right granted by law) for eligible children age 18 and younger
Minnesota Vaccines for Children Program
The Minnesota Vaccines for Children (MnVFC) program is Minnesotarsquos version of the federal VFC program By collaborating with over 820 sites throughout Minnesota MnVFC provides vaccines at no cost to children who may not otherwise be vaccinated because of the inability to pay Approximately one-third of Minnesota children are eligible for the MnVFC program These are children who are 18 years of age or younger and fall into one of the following categories
IPI Advisor Manual | February 2017 Page 5
The IPI Program Chapter 1
bull Uninsured bull Enrolled in a Minnesota Health Care Program Medical Assistance (MA) or MinnesotaCare bull American Indian or Alaskan Native or bull Underinsured children that are seen at a local health department Federally Qualified Health Center (FQHC) or Rural Health Center (RHC) Indian Health Services (IHS) and tribal health clinics
The majority of pediatric and family practice clinics are enrolled in MnVFC so children can stay with their health care home and still receive low-cost immunizations
When Congress enacted the VFC program they wanted to ensure that bull Sites manage their VFC vaccine appropriately so that there is little to no wastage of this valuable asset bull All eligible children receive the vaccine bull Immunization coverage rates increase by removing barriers to vaccination especially among high-risk children and by reducing disparities in access to health care
bull Vaccine is not used for the purpose of gaining profit for the provider or site
To assure these goals are achieved all states are required to conduct site visits for each enrolled site at least every other year As an IPI advisor you will be conducting the required MnVFC site visits in your county
Minnesota receives approximately $48 million of federally funded vaccine through the MnVFC program each year It is extremely important that these vaccines are managed properly and given only to the individuals that are eligible to receive them
Requirements to Participate in the MnVFC Program Initially providers must go through an enrollment process with MDH to receive vaccine from the MnVFC program This requires filling out the enrollment paperwork meeting the requirements in the appropriate MnVFC Policies and Procedures Manual and having an enrollment site visit by MDH staff
Following enrollment all sites receive their first MnVFC site visit within one year (preferably in 3-6 months) and then a MnVFC site visit at least every other year If you know of a provider who is not enrolled in the program a new clinic opens or if a site opens a satellite site in your county have them call the MnVFC program at 651-201-5522 to begin the enrollment process
Sites must meet many requirements to receive vaccine from the MnVFC program These requirements are identified in the MnVFC Policies and Procedures Manual There are two versions of the manual one for sites that keep separate stocks of public and private vaccine and another for sites that use the replacement method of vaccine management A copy of the appropriate manual is mailed to each site every fall The immunization manager vaccine coordinator and their back-ups must complete the annual online training based on the method of vaccine management their site uses All of the materials can be found on the MnVFC website (wwwhealthstatemnusvfc) Sites must complete the appropriate reports agreements and online training each year in order to continue to receive vaccine from the MnVFC program
Page 6 IPI Advisor Manual| February 2017
Chapter 2 IPI Advisors Your Role as an IPI Advisor As part of an MDH grant agreement with community health boards MDH contracts with local public health agencies to conduct MnVFC site visits in their county
As an IPI advisor you will be responsible for bull Attending the annual training provided by MDH bull Reviewing your county site visit lists and providing any known updates to your MnVFC clinical coordinatorplanner
bull Conducting site visits completing and submitting paper work within 10 days of the visit bull Following up with sites for unmet requirements identified at MnVFC site visits bull Notifying MDH when new sites open that will be storing and administering immunizations (in order to recruit new providers)
bull Keeping up-to-date with new recommendations and requirements for immunizations as well as the MnVFC program Read and be familiar with MnVFC and IPI web pages Sign up to receive email alerts for these resources by clicking on the red envelope at the top of these pages MnVFC Announcements (wwwhealthstatemnusdivsidepcimmunizemnvfcbfaxhtml) Got Your Shots News newsletter (wwwhealthstatemnusdivsidepcnewslettersgysindex html) Immunization Practices Improvement Program (wwwhealthstatemnusdivsidepc immunizeipiindexhtml)
Be designated as the IPI contact in Workspace (httpsoephealthstatemnusworkspace) for your organization Contact your organizationrsquos Workspace administrator to assign you this role
Annual training
Every spring MDH provides training for IPI advisors This training may be in-person or by webinar All IPI advisors are required to attend training each year to review site visit paperwork hear updates on the MnVFC program and ask questions about the process
Clinic lists
Early in the year MDH will send you a clinic list Your list will include all sites in your county that are enrolled in the MnVFC program The priority column indicates whether the IPI advisor MDH staff or the field epidemiologist should complete the visit Those sites not due for a visit that year will have the next year listed Every active MnVFC site is required to receive a site visit at least every other year You can do visits every year if you would like but this is not required Please review the list and notify your MnVFC clinical coordinatorplanner about any changes
IPI Advisor Manual | February 2017 Page 7
IPI Advisors Chapter 2
Included with the list is a one-page information sheet for each site This contains the sitersquos demographic information vaccine coordinator and immunization manager listed in our records whether they are a separate stock or replacement site and the doses and cost of vaccine they received last year Confirm this information with the site and discuss their vaccine quantity and value as part of the questionnaire during your visit
All site visits must be completed by Sept 30 2017 If you think you will be unable to complete all your visits by then you will need to contact your MnVFC clinical coordinatorplanner to determine how the visit will be completed
New IPI Advisor Training Requirements New IPI advisors need to contact MDH before performing any MnVFC site visits on their own A MnVFC clinical coordinatorplanner will help you prepare to perform site visits They will
bull Guide your training See the Training Checklist for IPI Advisors on the IPI Program Resources (wwwhealthstate mnusdivsidepcimmunizeipiresourceshtml) page
bull Have you shadow them or another experienced IPI advisor on one or two site visits bull Shadow you on a visit or two bull Complete the training document
Your MnVFC Clinical CoordinatorPlanner Your MnVFC clinical coordinatorplanner is a MDH staff member that will help support you See who your clinical coordinatorplanner is on IPI Contact Information (wwwhealthstatemnusdivsidepc immunizeipicontacthtml)
The role of the MnVFC clinical coordinatorplanner bull Provide assistance to IPI advisors bull Perform enrollment visits for new sites that will be administering MnVFC vaccine bull Review MnVFC site visit paperwork for accuracy bull Conduct MnVFC site visits where necessary bull Provide additional education or follow-up with sites bull Provide assistance and guidance regarding MnVFC requirements and recommendations to sites bull Provide training to IPI advisors and staff at MnVFC-enrolled sites bull Field storage and handling incident calls
Types of Visits MnVFC Site Visit ndash also known as the Compliance Visit
CDC requires all state immunization programs to conduct site visits to all VFC providers MnVFC site visits are required every other year but sites can be visited on a yearly basis if needed The site visit objectives are to
Page 8 IPI Advisor Manual | February 2017
IPI Advisors Chapter 2
bull Complete the MnVFC site visit paperwork found on IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml)
bull Provide education about MnVFC program requirements and recommendations to site staff bull Ensure MnVFC program requirements are properly implemented and are being met bull Provide feedback and as necessary execute corrective action bull Follow-up on identified issues bull Notify your MnVFC clinical coordinatorplanner of issues that are not resolved by the due date
Follow-Up Visit
In-person follow-up visits will not be necessary for most MnVFC site visitsmdashonly those where significant issues are identified in the original visit If you are not able to complete part of the initial site visit because you found a storage and handling incident or you found multiple issues that need to be addressed a follow-up visit may be necessary Please contact the MnVFC clinical coordinatorplanner for approval and guidance for conducting a follow-up site visit
Educational Visit
Some sites may need more information and education than you can provide during a normal site visit This may be on topics related to immunizations immunization practices or administration or storage and handling issues These visits go beyond the sharing of pamphlets resources or information that is presented at a site visit Education visits should be conducted with a group and should focus on a topic that is identified during a site visit or requested by site staff Regularly scheduled meetings are not considered educational visits Educational visits need to be approved prior to the visit by the MnVFC clinical coordinatorplanner in order for you to receive reimbursement from the MnVFC program
Unscheduled (Unannounced) Storage amp Handling Visit
Unscheduled (unannounced) visits are not pre-scheduled with the site These visits require different paperwork and focus primarily on the storage and handling portion of a MnVFC site visit The MnVFC program is required to visit 5 percent to 10 percent of enrolled sites as unannounced visits each year Please discuss any unscheduled visits you would like to do with the MnVFC clinical coordinatorplanner You should plan to complete all of your regularly scheduled visits before doing any unscheduled visits
Enrollment Visit
All sites (including satellite clinics) that receive stock or supply MnVFC vaccine must have an enrollment visit that is conducted by MDH staff As an IPI advisor you may be asked to attend the enrollment visit This is an opportunity for you to start your relationship with the site and help with follow-up that may be necessary for the site to receive MnVFC vaccine Newly enrolled sites are scheduled for their first regular site visit within the first year (preferably within 3 to 6 months) and then every other year
IPI Advisor Manual | February 2017 Page 9
IPI Advisors Chapter 2
Reimbursement for MnVFC Visits Local public health agencies are paid for the site visits they conduct MDH will reimburse participating agencies only after we receive all of the required paperwork Paperwork submitted with incorrect or missing information may delay the reimbursement
IPI program reimbursement is processed on a quarterly basis and is processed in the month following each quarter through an electronic transfer of money Your agencycounty IPI advisor contact will receive an email notification of the reimbursement
Reimbursement rates are updated annually and available on the Contracts and Reimbursements (www healthstatemnusdivsidepcimmunizeipicontreimhtml) page
2017 MnVFC Site Visit Reimbursement Rates MnVFC Site Visit $400 Follow-up Visit$150 Education Visit$100 Unscheduled Visit$300
Reasons MDH Would Do All or Part of a Visit MDH may complete site visits or accompany you on a site visit if
bull The site is new to the MnVFC program (enrollment visit) bull The site has known issues or concerns regarding the MnVFC program especially if you are having difficulty resolving these issues
bull The site is refusing a site visit from local public health or yoursquore having a difficult time scheduling a visit
bull The site is part of tribal health or Indian Health Services bull MDH district epidemiologists will perform site visits at local health departments bull A new IPI advisor needs training from MDH staff bull Note MDH district epidemiologists will perform site visits at local health departments
Page 10 IPI Advisor Manual | February 2017
Chapter 3 Site Visits Scheduling the Visit
bull Check the information sheet or contact the site to confirm who the contact person is in charge of the MnVFC program In general this is the immunization manager or vaccine coordinator If the contact is no longer there ask for the person in charge of the sitersquos vaccines or the clinic manager They can usually direct you to the appropriate person You may want to follow a suggested phone script when contacting the site
Sample Phone Script for Scheduling a Visit
ldquoHello My name is _______ I am calling from ________ Health Department May I speak to (contact name) [If not available determine appropriate person to talk to or a better time to call back] I am calling to schedule a MnVFC site visit This visit will involve a review of immunization practices at your site We will look at vaccine administration storage and handling screening for eligibility and documentation of vaccinations It usually takes about two hours for a visit depending on the number of vaccine storage units you have Is there a day or time of day that works best for you
I have a pre-visit worksheet to send to you to help you prepare for the visit It contains information about what I will need at the visit such as temperature logs and immunization documentation information Completing this worksheet prior to me arriving will help the visit be more efficient Is there any other information that I can send to help you prepare for the visit
If you have any questions call me at ________ Thank you for your time and assistance I look forward to working with yourdquo
bull Arrange a date and time for the visit bull Let them know an approximate visit length Visits are usually around two hours long depending on the size of the site the number of vaccine storage units they have or if they have new staff
bull Request that key staff be present at the visit This could include the immunization manager vaccine coordinator immunization staff clinic manager nurse manager billing staff andor medical director
bull Inform your site contact that you will be sending them an email confirmation along with the MnVFC
Pre-Visit Worksheet
Site Visit Checklist Use the Site Visit Checklist on IPI Advisor Site Visit Materials (wwwhealthstatemnusdivs idepcimmunizeipisvmaterialshtml) to make sure all necessary steps are covered
MINNESOTA VA C CI N ES FO R CHI LD REN PROGRAM
Site Visit Checklist Date of visit Time
Site Name PIN
Address
Contact Phone
Complete Before the visit Comments
Review the clinic list Identify and prioritize which sites you will visit
Email or call to schedule a date and time for the visit Ask for the immunization manager or vaccine coordinator
Email appointment confirmation attach Pre-visit Worksheet and provide instructions for returning it prior to the visit (sample email on website) Include length of the visit and which staff should be present
Add site visit to Outlook calendar and reserve a car (if needed)
Review temp logs and Pre-visit Worksheet
Send a reminder email 2-3 days ahead of the visit
IPI Advisor Manual | February 2017 Page 11
i i li
Site Visits Chapter 3
Information for the Visit2017 MnVFC Pre-Visit Worksheet Site name MnVFC PIN
Address
Medical director Email
Immunization manager Phone
Vaccine coordinator Phone
Vaccine coordinator back-up Email
IPI Site Vis t Preparat on Check st
The staff listed have completed the MnVFC online training and printed a certification of completion Immunization Manager Vaccine coordinator Vaccine coordinator back-up
Have a copy of the most recent provider agreement
Check if the above listed staff have changed since the provider agreement was completed
Check all of the vaccines administered at your site and list the corresponding publication date for each VIS you give to patients
DTaP _____________ Hepatitis A _____________ Hepatitis B _____________ Hib _____________ HPV _____________
Influenza _____________ MCV4 _____________ MMR _____________ MMR-V _____________ PCV13 _____________
Polio _____________ Rotavirus _____________ Tdap _____________ Varicella _____________
Non-Routine Vaccines Men B__________ PPSV23 _____________ Td _____________
Vaccine administration fee charged for MnVFC eligible children is $
Have a Vaccine Management and Emergency Plan that has been reviewed and dated within the last year
Have the borrowing reports if applicable for the last 12 months available at the visit
Have an anaphylaxis protocol that is clearly posted and reviewed annually
Send an appointment reminder email and the MnVFC Pre-Visit Worksheet to the MnVFC contact A sample letter and the MnVFC Pre-Visit Worksheet can be found on the IPI Advisor Site Visit Materials (wwwhealthstate mnusdivsidepcimmunizeipisvmaterialshtml) page You can request that the MnVFC Pre-Visit Worksheet and temperature logs be sent to you prior to the visit for your review
Contact the site by phone or email one or two working days before the scheduled visit to confirm your appointment This is also a good time to ask for directions and parking information if you are not familiar with the site
Preparing for the Visit Review the site visit paperwork to familiarize yourself with the questions For most of the questions there is a ldquoNote to the reviewerrdquo These notes give helpful tips about the information you are looking for when asking this question It contains the rationale for the question and which resources to provide to the site to support the rationale Some sections also require immediate on-site actionsmdashthings you must do while you are at the site and some require future follow up
bull Print copies the of site visit paperwork bull Site visit forms are available on the IPI Advisor Site Visit Materials (wwwhealthstatemnusdivs idepcimmunizeipisvmaterialshtml) page 2017 MnVFC Site Visit Questionnaire 2017 MnVFC Site Visit Storage amp Handling per Unit Answer Sheet (print one for each stand-alone andor combination storage unit at the site) 2017 MnVFC Provider Follow-up Plan (print two copies)
bull Review any previous site visit paperwork that is available You should check in with MDH staff after your visits if the site continues to have the same issues as past visits
bull Also be sure to bring Your thermometers If the sitersquos certificate of calibration is expired or the probe is not properly placed place your thermometer in the storage unit when you arrive and read the temperature just prior to reviewing the site visit findings
The MnVFC folder with additional immunization resources you wish to add (see chapter 5) and the Vaccine Storage amp Handling magnet (to order email healthIPIinquiriesstatemnus) A copy of the appropriate MnVFC Policies and Procedures Manual found on the MnVFC website (wwwhealthstatemnusvfc) Appropriate temperature logs (Celsius or Fahrenheit) Site information sheet that contains the quantity and value of the vaccine distributed to the sitesystem
Page 12 IPI Advisor Manual | February 2017
Site Visits Chapter 3
Conducting the Visit Education is a large part of the MnVFC site visit Often approaching this visit as an exchange of information with the site is more successful than a ldquoregulatoryrdquo visit Putting the staff at ease answering their questions and making a plan to address issues that arise during the visit is more helpful than a ldquopassfailrdquo attitude Education will usually consist of providing the rationale for the requirement referring to the requirement in the MnVFC Policies and Procedures Manual and providing resources to help address the situation Some questions will require additional follow-up to assure the site has corrected the issue(s) and is meeting the MnVFC requirement(s) This will be addressed further in the follow-up section
Completing the Paperwork
There are three documents that you must complete for the MnVFC site visit bull 2017 MnVFC Site Visit Questionnaire bull 2017 MnVFC Site Visit Storage amp Handling per Unit Answer Sheet (one for each storage unit) bull 2017 MnVFC Provider Follow-up Plan (two copies or you may ask them to make you a copy of the completed form for their records)
Answer the questions on the MnVFC Site Visit Questionnaire based on how things are when you arrive at the site If they correct the issue during the visit you will still mark it as an unmet requirement and document how it was addressed during the visit
The ldquoAnswerrdquo field will contain all the possible answer choices for this question For most questions answer choices will be followed by the markings below
bull Answer choices with no marking mean the site meets the CDC requirement bull Answer choices marked with an [X] indicate that this specific answer choice is non-compliant with a CDC requirement
bull Answer choices marked with an [O] indicate that this specific answer choice is not aligned with a CDC recommendation
If you marked the box with the [X] which is non-compliant with the CDC requirement conduct a root cause analysis to determine the reason for non-compliance Root cause analysis is an important component to a successful site visit It is used to identify the cause of the problem and help to resolve the issue There are several possible root causes that can be identified Choose only one root cause
bull Human cause Personal beliefsopinions Does not understand rationale of requirement Lack of concern for compliance
bull Organizational cause Competing job assignmentsworkload Lack of (insufficient) staff to perform required duties Budget limitations (for required equipment) Lack of (insufficient) training of staff Lack of (insufficient) processesprotocols
IPI Advisor Manual | February 2017 Page 13
Site Visits Chapter 3
Once identified the root cause should be documented in the questionnaire including a brief explanation of why you chose that cause This allows for follow-up with the site and a way to help find improvements to meet the unmet requirement Complete any immediate on-site action These often require providing education and resources for the site Mark the box for each action taken If you provide additional resources or information you can use the notes section to indicate the additional items
ldquoFuture follow-uprdquo are actions the site needs to take to meet the requirements of the program Wersquoll go over more specific information about the site visit questionnaire in Chapter 4
Performing the Site Visit
As you become familiar with the MnVFC program and develop a relationship with your sites you will develop a visit pattern that works for you Here is one possible sequence for conducting MnVFC site visits
bull When you arrive at the site if you have a business card it is helpful to provide it to the front desk staff person
bull When you meet with the immunization manager andor vaccine coordinator introduce yourself and explain the expectations for the visit
bull Ask to see the temperature monitoring device(s) It must have a current certificate of calibration and the probe must be properly placed in the unit If it does not meet the requirements place your thermometer in the unit at the beginning of the visit so that it has sufficient time to reach an accurate temperature by the time you complete your assessment of the storage units
bull 2017 MnVFC Site Visit Questionnaire Ask all of the questions You may have to modify the order of the questions based on what is best for the site When you get to the storage and handling section (section 4) use the answer sheet(s) to document the answers to the questions for each storage unit that stores vaccine (MnVFC or private) Do not write answers in the questionnaire unless there is an unmet requirement Be sure to ask if there is vaccine stored anywhere else at any time at this location This includes a co-located pharmacy If so these additional units will need to be assessed as well If the site has a combination refrigeratorfreezer household unit and is using both sections discuss with them the recommendation (and probable future requirement) to have a separate freezer Refer to MDH if they have further questions or need more information Be prepared to address any storage and handling mishaps that you may find A copy of the
Clinicianrsquos Vaccine Mishap Checklist is with your visit materials and the Emergency Response Worksheet is in the MnVFC Policy and Procedure Manual If you are unsure how to handle the problem call the MnVFC program at 651-201-5522 during or after the visit
Page 14 IPI Advisor Manual | February 2017
Site Visits Chapter 3
Ending the Visit bull Fill out the two copies of the 2017 MnVFC Provider Follow-up Plan (or ask them to make a copy once it is completed for their records) Indicate if they have not met the requirement by checking the box in the ldquoUnmetrdquo column If they are not meeting requirements check the required actions Review the plan with them reinforcing the positive things they are doing as well as reviewing the required follow-up action(s) Give the site a copy of the Provider Follow-up Plan Keep the signed copy of the Provider Follow-up Plan to submit with your paperwork Do not leave a copy of the Site Visit Questionnaire at the site
bull Let them know you will be sending a thank you email that will summarize the site visit Included in the email will be a survey link you would appreciate them completing regarding the visit
After the Visit bull Send the site a thank you email There is a template thank you letter on the IPI Advisor Site Visit Materials (wwwhealthstate mnusdivsidepcimmunizeipisvmaterialshtml) page Be sure you include the issues that you identified and the timeline for their completion as well as the good things you found at the visit In the template letter be sure to include the survey link The survey is very brief ndash a few questions and space to write comments
bull Either transfer your MnVFC Site Visit Questionnaire and MnVFC Site Visit Storage amp Handling per Unit Answer Sheet information to the fillable version or submit the handwritten form to MDH
Documentation of the Visit
Paperwork must be submitted to MDH within 10 days of the visit in order to meet the federal VFC programrsquos reporting requirements Do not wait to complete your follow-up before submitting the site visit paperwork
Send the following documents to MDH bull 2017 MnVFC Site Visit Questionnaire (includes the cover sheet) bull 2017 MnVFC Site Visit Storage amp Handling per Unit Answer Sheet (one for each unit) bull 2017 MnVFC Provider Follow-up Plan (original signed plan)
Submit site visit materials to bull Email healthIPIinquiriesstatemnus (preferred) bull Mail IPI Program Specialist
Immunization Practices Improvement Program Minnesota Department of HealthPO Box 64975St Paul MN 55164-0975
IPI Advisor Manual | February 2017 Page 15
Site Visits Chapter 3
Future follow-up Follow-up is an important component of the site visit It helps us ensure that the unmet requirements have been corrected The questionnaire has different time periods for follow-up depending on the question Do not wait to complete your follow-up before submitting the site visit paperwork
When you complete the Follow-Up Form make sure to keep a copy for yourself MDH also keeps track of follow-up required and will remind you if follow-up has not been completed by the deadline Most follow-up can be done with a phone call or email In-person follow-up is rarely required and should be discussed with MDH before scheduling a follow-up visit
All requirements that need follow-up are identified with a [X] on the site visit paperwork and are listed on the MnVFC Provider Follow-up Plan
bull Follow-up with the site to see how they have resolved the unmet requirements bull Document your follow-up on the Follow-Up Form available on the IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml) page If follow-up was done via letter or email a copy can be attached to the Follow-Up Form
bull Send your Follow-Up Form to MDH (healthIPIinquiriesstatemnus) with supporting documents and emails
bull If a site is not responding to your requests regarding follow-up contact your MnVFC clinical coordinatorplanner They can help with additional follow-up as needed
Page 16 IPI Advisor Manual | February 2017
Chapter 4 The 2017 MnVFC Site Visit Paperwork This chapter will go through the required MnVFC site visit paperwork with notes about information or resources to help the site address questions or issues that may arise during the visit
The MnVFC site visit paperwork is available on the IPI Advisor Site Visit Materials (wwwhealthstate mnusdivsidepcimmunizeipisvmaterialshtml) page
Please download the paperwork shortly before your visit as there may be updates and changes and this will be the most up-to-date version of the questionnaire We will send out a Workspace message with major changes
Required Paperwork for Site Visits bull 2017 MnVFC Site Visit Questionnaire bull 2017 MnVFC Storage amp Handling Per Unit Answer Sheet ndash one for each unit assessed during site
visit bull 2017 MnVFC Provider Follow-up Plan ndash with provider signature
Make sure to include the sitersquos PIN on all your paperwork Please complete and submit your site visit paperwork as soon as possible after your visit It may be helpful to schedule some time into your calendar to complete your paperwork in the days following your visit Once you have completed the post-visit follow-up send in the Follow-Up Form with documentation of the follow-up actions Please do not wait until you have completed your follow-up before sending in your initial paperwork
MnVFC Site Visit Questionnaire The questionnaire includes these six sections 1 Provider details 2 Eligibility 3 Documentation 4 Storage amp handling per unit 5 Storage amp handling site-wide 6 Inventory
IPI Advisor Manual | February 2017 Page 17
Page 18 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
The Site Visit Reviewer Legend The legend explains the formatting of the 2017 questionnaire This includes information that will be helpful in completing the site visit
Site Visit Reviewer Guide Legend
Section Number Content Area
Question number This area will always contain the text of the question
Note to reviewer The note to reviewer contains information that is necessary for properly asking and assessing responses tothe question above This may include definitions of terms requirement details and other helpful tips
Answers This field will contain all the possible answer choices for this question For most questions answer choiceswill be followed by the markings below
Answer choices marked with an [X] indicate that this specific answer choice is non-compliant with a CDC requirement Answer choices marked with an [O] indicate that this specific answer choice is not aligned with a CDC
recommendation
Review CDC RequirementRecommendation
This field will be populated with the CDC requirementrecommendation associated with the given question
Actions if Non-Compliant
Root Cause Analysis As part of the site visit reviewers are required to assess and understand the reasons why a provider office isnon-compliant with VFC program requirements ndash this is a root cause analysis Reviewers must choose theone root cause that they believe most contributes to the non-compliance Upon establishing the root causethe reviewer must provide a clear explanation of hisher findings
Immediate Action These are actions that CDC requires reviewers to take on site during the visit
Future Follow-up These are future follow-up actions (with designated due dates) that are required of the reviewer andorprovider to remedy non-compliance Reviewers must complete all follow-up in accordance with CDCestablished deadlines
Notes Information you want the VFC program to be aware of or that explains your answer in detail
bull Note to reviewer These are notes to help you understand what the question is asking for and to clarify things you might want to know when asking or rephrasing the question
bull Answers This section helps you to know when the answer does not meet the CDC requirement [X] or recommendation [O] Whenever an answer with a [X] is checked the ldquoActions if Non-compliant section must be completed The recommendations are usually good teaching points about best practices andor future requirements of the VFC program
bull Review the CDC RequirementRecommendation This section provides a specific outline of the requirement or recommendation to give you information to use in talking with the site staff
bull Actions if Non-Compliant This section describes what to do if the site is not meeting a requirement Root cause analysis This section asks you to probe beyond the surface to find what is driving the non-compliance It is intended to help uncover reasons for recurring non-compliance issues identify additional training needs and inform reviewer follow-up actions Select only one root cause and explain the particular circumstances in the space ldquoExplanation of root causerdquo line provided If there appear to be multiple issues choose the one that most contributes to the non-compliance and describe all factors in the explanation Immediate actions A list of actions to take during the site visit to address the issue Future follow-up A list of actions to take after the site visit by the set deadline
bull Notes This section can be used for notes to yourself or to MDH
IPI Advisor Manual | February 2017 Page 19
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 1 Provider Details Questionnaire Coversheet
The first page of the questionnaire collects the demographic information for the site You can use this page to help prepare for the visit Most of the demographic information about the site should be on the site-specific document you received with your clinic list You will validate that this information is current at the time of the site visit It also helps to know if this is a separate stock site or a replacement site before the visit so you can bring a copy of the appropriate MnVFC Policies and Procedure Manual
2017 MnVFC Site Visit Questionnaire Date of visit _____________ Date forms sent to MDH ______________
Site Information
Site name MnVFC PIN
Address Separate Stock Replacement
City ZIP County
Medical Director Email
Immunization Manager Phone
Vaccine Coordinator Phone
Vaccine Coordinator back-up Email
Point of contact Phone
Personnel at site visit
On this page bull The date of the visit and the date when you send these forms to MDH This information helps us track the timeliness of our review and data entry process
bull The vaccine management method used by the site (replacement or separate stock) bull The name and email of the medical director (ideally this is the person who signed the MnVFC
Program Provider Agreement)bull Contact information for the immunization manager vaccine coordinator vaccine coordinator back-up and point-of-contact for this visit The immunization manager vaccine coordinator vaccine coordinator back-up roles are
described in the MnVFC Policies and Procedure Manual The vaccine coordinator back-up may be the immunization manager or another staff person depending on the size of the site and available personnel The Point of Contact is the person you set up the appointment with signs the Provider Follow-
up Plan and receives the follow-up email This may be one of the people listed above
The Post Visit Steps section is a reminder to you about what needs to done after the visit The Education on Immunization Best Practices for Sites section reminds you to provide the resource folder to the site
Page 20 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 12
1 Provider Details Changes to Key Staff
Question 12 Ask the provider about changes to key staff to answer the questions below
A (Choose all that
apply)
At the time of the visit is the Medical Director the same individual that signed the ProviderAgreement and are the Immunization Manager and Vaccine Coordinator the same asthose last reported to the program
Yes No the Medical Director has changed No the Immunization Manager has changed No the Vaccine Coordinator has changed
B (Choose one)
Were all changes communicated to theImmunization Program according to yourprogramrsquos policy
Yes or no staff changes No [X]
C (Choose one)
Based on review of the trainingdocumentation have the current Immunization Manager Vaccine Coordinator and back-up completed all required training
Yes No [X]
Review CDC Requirement
All changes in key staff must be communicated to the Immunization Program in the manner and timeframe defined by theImmunization Program Key staff include the Medical Director or equivalent who signed the Provider Agreement the Immunization Manager Vaccine Coordinator and the back-up VFC providers are required to ensure that all key staff are fully trained on VFC program requirements at all times All training must be documented
Goal of this question Determine if there are new staff in key positions at the site and to make sure staff are properly educated about the MnVFC program A This information can help you determine the level of knowledge and experience the staff have with the MnVFC program Follow-up throughout the visit can be tailored for various levels of staff experience Likewise you may identify additional training needs for new staff
B When sites notify us of changes in key personnel we update their information in MIIC and on the clinic lists We also send the new staff information for completing the online training and direct them to read the appropriate MnVFC Policies and Procedures Manual If the answer to this part is no update the demographic area of the questionnaire and inform the staff that in the future they must notify the MnVFC program (via email or phone) if the immunization manager or vaccine coordinator changes Resource Section 12 of the MnVFC Policies and Procedures Manual
C Annual training must be verified by looking at the certificates for the online training If the answer to this part is no refer the staff to complete the appropriate MnVFC online training found on the MnVFC website (wwwhealthstatemnusvfc) for their program (separate stockreplacement) for the current year and send you a copy of the certificate within 30 days
Resource bull Sections 12 and 14 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 21
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 2 Eligibility Question 21
Goal of this Question Assess whether staff correctly understand which patients are eligible for the MnVFC program Screening ensures that eligible children receive the vaccines that they are entitled to receive under the MnVFC program and helps to prevent fraud or abuse of the program
Children 18 years and younger in these
categories can receive MnVFC vaccine at any enrolled site bull Uninsured bull Enrolled in a Minnesota Health Care Program (MHCP) Medical Assistance (MA) or MinnesotaCare bull American Indian or Alaskan Native
The following categories are considered underinsured and are only MnVFC-eligible at local public health (LPH) Federally Qualified Health Centers (FQHC) Rural Health Centers (RHC) Indian Health Services (IHS) and tribal health clinics
bull Has health insurance that does not cover one or more vaccines as can be the case with newly licensed vaccines that arenrsquot yet covered (MnVFC-eligible for non-covered vaccines only)
bull Has health insurance that caps vaccine coverage at a certain amount Once that amount is reached the child is MnVFC-eligible
Children with insurance that does not cover vaccines until a deductible has been met are considered to be fully insured and are not MnVFC-eligible
Helpful information bull Sites are not required to verify the patientrsquos response to the screening questions For example if a patient states they lost their insurance the site does not need to call the patientrsquos insurance company to confirm
If the site cannot correctly describe the eligibility categories provide educational materialsresources on MnVFC eligibility requirements
Resources bull Patient Eligibility Screening Record on MnVFC Forms (wwwhealthstatemnusdivsidepc immunizemnvfcformshtml)
bull Section 1 of the MnVFC Policies and Procedures Manual
2 Eligibility VFC Eligibility Categories
Question 21 Was the individual responsible for determining patient VFC eligibility able to explain all the factors(including age) that make a child eligible to receive VFC vaccines
A Patient is less than 19 years of age Yes No [X]
B Patient is Medicaid-eligible Yes No [X]
C Patient is uninsured Yes No [X]
D Patient is underinsured Yes No [X]
E Patient is American Indian Yes No [X]
F Patient is Alaska Native Yes No [X]
Review CDC Requirement
VFC providers must possess a working knowledge of all VFC eligibility criteria and use those criteria to screen children prior toadministering VFC vaccines In order to receive VFC vaccine a patient must be under the age of 19 and must be at least one of the following (1) Medicaid-eligible (2) Uninsured (ie child has no health insurance) (3) Underinsured (ie child has health insurancebut coverage does not cover any or certain vaccines ndash underinsured children may only receive VFC vaccines in FQHCRHC ordeputized VFC provider offices and only for vaccines not covered by insurance) and (4) American Indian or Alaska Native (AIAN)
Page 22 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 22
2 Eligibility Billing Practices
Question 22 Is the individualdepartment responsible for billing able to clearly explain how they bill for both the costof vaccine and the vaccine administration fee for each of the eligibility categories below
A Medicaid-eligible Cost of Vaccine Do not bill ndash provided by VFC Admin Fee Bill Medicaid
Yes No [X]
B Uninsured Cost of Vaccine Do not bill ndash provided by VFC Admin Fee If billing can bill patient
Yes No [X]
C Underinsured Cost of Vaccine Do not bill ndash provided by VFC through FQHCsRHCs or deputized providers only all other providers cannotprovide VFC vaccine to underinsured patients Admin Fee If billing can bill patient
Yes No [X]
D American IndianAlaska Native(AIAN)
Cost of Vaccine Do not bill - provided by VFC unless patient is fully insured and parent chooses to use insurance Admin Fee If patient is Medicaid-eligible bill Medicaid if billingand patient is uninsuredunderinsured can bill patient if parentchooses to use private insurance for cost of vaccine billpatientinsurance
Yes No [X]
E Do individuals responsible for billing have access to the results of eligibility screening toensure proper billing
Yes No [X]
Review CDC Requirement
VFC providers must adhere to proper billing practices for vaccine administration fees and clearly understand that VFC vaccine isprovided at no cost to both the VFC provider and eligible children At no time should billing occur for the cost of VFC vaccine Whenadministering VFC vaccine providers should never bill two different ldquopayersrdquo (ie patient Medicaid insurance) for the samevaccine administration fee amount For Medicaid-eligible children Medicaid should be billed for the vaccine administration fee Forall other VFC-eligible populations the patient may be billed within the stateterritory cap established by the Centers for Medicareand Medicaid (CMS) However patients cannot be turned away or reported to collections for inability to pay the administration fee
Goal of this question Determine if the staff correctly understand how to bill patients that are eligible for the MnVFC program Billing appropriately ensures that children can receive low cost immunizations and the site is in compliance with the VFC program
bull If there is any indication that sites could be billing insurance companies or parents for VFC vaccines this should be investigated further
bull Most sites in Minnesota will bill Medicaid with the SL modifier ndash which indicates this is a Medicaid claim
bull The main point is to ensure the site is not billing uninsured children for VFC vaccine and are not charging them more than $2122 per vaccine for the administration fee
bull Non-compliance is usually unintentional and may be resolved with some training In rare cases it could be a glimpse into a larger problem where a site is intentionally billing for financial gain
bull If you think the site is billing inappropriately it is the responsibility of the IPI advisor to report concerns to MDH staff for further assistance
Resources bull Immunization Billing Guidance for MnVFC (wwwhealthstatemnusdivsidepcimmunizemnvfc billingtipshtml) or Immunization Billing Guidance for MnVFC Replacement Method Sites (www healthstatemnusdivsidepcimmunizemnvfcreplacementbillingtipsrephtml)
bull Section 2 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 23
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 232 Eligibility Vaccine Administration Fee
Question 23 Document the actual vaccine administration fee charged to non-Medicaid VFC-eligible patients (confirmwith billing department)
Answers Fee $ [X] Follow-up is required if the provider charges more than the fee cap establishedby the Centers for Medicare and Medicaid (CMS) for your stateterritory ($2122)
Review CDC Requirement
The VFC providerrsquos vaccine administration fee for non-Medicaid VFC-eligible children must not exceed the stateterritory vaccineadministration fee cap established by the Centers for Medicare and Medicaid (CMS) For current fee caps refer to Medicaid Program Payments for Services Furnished by Certain Primary Care Physicians and Charges for Vaccine Administration Under theVaccines for Children Program Final Rule (httpwwwgpogovfdsyspkgFR-2012-11-06pdf2012-26507pdf)
Goal of this question Ensure that sites are not charging more than the federal allowable vaccine administration fee of $2122
bull The Centers for Medicaid and Medicare (CMS) establishes a maximum fee that sites can charge to non-Medicaid-eligible VFC patients in each stateterritory for vaccine administration Health Plans usually negotiate this fee with the site but Medicaid will not pay more
bull If a parent cannot pay the vaccine administration fee the patient cannot be turned away or reported to collections VFC-eligible children must be vaccinated regardless of their ability to pay
bull If the person with whom you are conducting the site visit does not know the exact fee charged to non-Medicaid VFC-eligible patients ask to speak to someone who can verify the exact amount
bull If they are charging more than $2122 for the administration fee ndash please contact MDH staff for help with addressing this situation
Resources bull Immunization Billing Guidance for MnVFC (wwwhealthstatemnusdivsidepcimmunizemnvfc billingtipshtml) or Immunization Billing Guidance for MnVFC Replacement Method Sites (www healthstatemnusdivsidepcimmunizemnvfcreplacementbillingtipsrephtml)
bull Section 2 of the MnVFC Policies and Procedures Manual
Page 24 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 3 Documentation Question 31
3 Documentation Eligibility Screening amp Documentation
Question 31 To answer the questions below the provider must clearly demonstrate the patient intake processReview a minimum of 10 records that contain an immunization visit within the last 6 ndash 12 months
Note to Reviewer Criteria for Record Selection 1) Record selection must be completely random and the provider must not know prior to the visit which
records will be reviewed 2) Patient must have been 0-19 years of age at the last visit (Note Records of 19-year-old patients may
allow you to see if VFC vaccines are being used beyond the allowable age) 3) Must review a mix of public and private-pay patients (if applicable)
A Does the provider have a process that ensures that patients are screened forVFC eligibility at each visit and that screening results are documented at each visit
Yes No [X] (If no skip question F)
B Does the providerrsquos process ensure that staff administering vaccine know which vaccine stock to select from prior to drawing the vaccine
Yes No [X]
C Number of records reviewed If fewer than 10 records are reviewed select the reason why Provider does not have 10 patient records with immunizations in last 12 months
D Do all records contain date of the immunization visit and patientrsquos date of birth Yes No [X]
E Do all records contain the patientrsquos specific eligibility status associated with thedate of the immunization
Yes No [X]
F Do any of the providerrsquos records contain any evidence that the patient received vaccine for which they were not eligible
Yes [X] No
Review CDC Requirement
VFC providers must screen for and document VFC eligibility at each immunization visit Documentation must include the date of the visit and the childrsquos specific eligibility category VFC providers must use screening results to ensure that only VFC-eligible children receive VFC vaccine and that administration fees are billed for as appropriate Eligibility status must be readily available to staff administering vaccine prior to selecting which vaccine stock to use
Goal of this question Ensure the site is screening for eligibility and documenting the eligibility category in the medical record
Review a minimum of 10 records from within the last 6-12 months where the patient received an immunization You must review a mix of public and private pay patients (if applicable)
Random selection is important If the staff have pre-selected records for review do not use and identify additional randomly selected records to review
Helpful information bull Discuss upgrading the electronic health record to make documentation of VFC eligibility screening a required field Documenting eligibility screening in the immunization field promotes better MIIC data
bull Q 31 B Sites using the replacement method of vaccine management only have one stock so you will answer ldquoYesrdquo to this question
Resources bull Patient Eligibility Screening Record on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfcformshtml)
bull Section 1 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 25
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 32
3 Documentation Vaccine Dose Documentation
Question 32 Review a minimum of 10 patient immunization records from the last six months (or 12 months ifnecessary) to assess compliance with documentation requirements set forth by Statute 42 US Code 300aa-25 (See note to reviewer below)
Note to Reviewer Criteria for Record Selection 1) Record selection must be completely random the Provider must not know prior to the visit which records
will be reviewed 2) Patient must have been 0-19 years of age at the last visit (Note Records of 19-year-old patients may allow
you to see if VFC vaccines are being used beyond the allowable age)
Records are Compliant if they Contain ALL the Below Elements
bull Address of clinic where vaccine was administered bull Publication date of VIS bull Name of vaccine administered bull Name of vaccine manufacturer bull Date vaccine was administered bull Lot number bull Date VIS was given bull Name and title of person who administered the
vaccine
A Number of records reviewed
B Number of records that contain ALL required documentation elements
If fewer than 10 records are reviewed select the reason why Provider does not have 10 patient records with immunizations in last 12 months
[X] Follow-up isrequired if one ormore records do not meet requirements
Goal of this question Assess whether the site is documenting all required information in each patientrsquos medical record for every vaccine dose administered in accordance with the National Childhood Vaccine Injury Act
Resources bull Section 6 of the MnVFC Policies and Procedures Manual bull National Vaccine Injury Compensation Program (wwwhrsagovvaccinecompensation)
Question 33
3 Documentation Record Retention
Question 33 Is the provider able to demonstrate (preferred) or clearly describe how they maintain historical VFCeligibility documentation for three years
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers are required to maintain all records related to the VFC program for a minimum of three years (or longer if requiredby state law) and upon request make these records available for review VFC records include but are not limited to VFC screening and eligibility documentation billing records medical records that verify receipt of vaccine vaccine ordering records and vaccinepurchase and accountability records
Goal of this question Make sure the site understands they are required to keep all MnVFC screening documentation for at least three years either electronically or on paper This information should be available to you at the time of the visit and future visits
Resource bull Section 7 of the MnVFC Policies and Procedures Manual
Page 26 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 34
3 Documentation Borrowing Documentation
Question 34 Discuss borrowing practices with the provider to answer the questions below
Note to Reviewer bull To be considered ldquofully documentedrdquo documentation for each borrowed dose must include thefollowing information
Vaccine type borrowed Date the dose was administered Stock used (VFC or private) Reason appropriate vaccine stock was not used Patient name and date of birth Date dose was returned to appropriate stock
A Did the provider state that they had borrowed any vaccines (whetherdocumented or not) since the last VFC Compliance Site Visit
Yes No (If no skip to question 36)
B Are there any doses for which there is no documentation (ie provider hasindicated that doses were borrowed but cannot verify how many or why)
All doses are documented Some doses are not documented [X] No doses are documented [X] (if nodoses documented skip toquestion 36)
C Were all borrowed doses fully documented (See Note to Reviewer above) Yes No [X]
D Were all borrowed VFC doses either replaced or an order submitted to replacethe doses Yes No [X]
Review CDC Requirement
VFC providers are expected to maintain an adequate inventory of vaccine for VFC and non-VFC-eligible patients It is theresponsibility of the VFC provider to appropriately schedule and place vaccine orders VFC providers must also rotate stock to ensure timely use of short-dated vaccines Borrowing of vaccine between private and public inventories must be a rare unplanned occurrence and cannot serve as a replacement system for a VFC providerrsquos privately purchased vaccine inventory All instances ofborrowing must be properly documented reported and replaced
Goal of this question Assess vaccine accountability by verifying that children are receiving vaccine from the appropriate stock
Borrowing is when a fully insured child receives a dose of MnVFC vaccine or a MnVFC-eligible child receives a dose of private vaccine This should be a rare unplanned occurrence The site must document any borrowing of vaccine between stocks ideally on the VFC Borrowing Report Form If they are not currently using the form review it with them and encourage them to post it close to their vaccines It does not need to be sent to MDH but should be kept for 3 years and filed with their MnVFC documents to be reviewed whenever they have a regular or unscheduled (unannounced) site visit
Helpful information bull Understand and report on staffrsquos verbal (ie anecdotal) accounts of borrowing obtained during the visit Often sites do not know that what they do is considered borrowing or they think borrowing is acceptable and documentation isnrsquot needed so long as those vaccines are eventually replaced
bull Since sites using the replacement method only have one stock of vaccine they very rarely borrow bull This question asks for future follow-up in 6 months Make a note on your calendar and ask them to send you a copy of their borrowing reports for the previous 6 months with documentation of doses borrowed and replaced We will remind you if we donrsquot hear from you at the 6 month time frame Complete the Follow-up Form and attach the borrowing form
Resources bull Vaccine Borrowing Report on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfc formshtml)
bull Section 10 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 27
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 353 Documentation Borrowing Reasons
Question 35 Based on your discussion with the provider and a review of borrowing reports document the dosesborrowed for each reason and answer the questions below
Note to Reviewer bull Short-dated vaccines are doses that are likely to expire before they can be used bull Exchanging short-dated vaccines should only occur in practices that have a small number of private
patients
A Reasons for Borrowing a VFC Dose (Enter the number of _____ Private vaccine shipment delay (order placed on time but delay in shippingreceipt)
vaccine doses borrowed for each
reason in the spaces
_____ Private vaccine not useable on arrival (vials broken temperature monitor out of range) _____ Ran out of private vaccine between orders (provider orders not placed on time) [X]
provided) _____ Short-dated private dose was exchanged with VFC stock _____ Accidental use of VFC dose for a private patient (human error) _____ Replacement of private dose with VFC when insurance plan did not cover vaccine _____ OtherDocumented dose did not include reason for borrowing [X]
(Explanation Required) Reasons for Borrowing a Private Dose _____ VFC vaccine shipment delay (order placed on time but delay in shippingreceipt) _____ VFC vaccine not useable on arrival (vials broken temperature monitor out of range) _____ Ran out of VFC stock between orders (provider orders not placed on time) [X] _____ Short-dated VFC vaccine dose was exchanged with private dose _____ Accidental use of a private dose for a VFC-eligible patient (human error) _____ OtherDocumented dose did not include reason for borrowing [X]
(Explanation Required)
B Enter date range for instances of borrowing reviewed in the borrowing report Note If ldquoDate of earliest instancerdquo is not available use the date of the last VFC Compliance Visit If ldquoDate of last instancerdquo is not available use the date of thecurrent VFC Compliance Visit
Date of earliest instance
Date of last instance
C Does borrowing appear to be a routine practice Note To determine whether borrowing is a routine practice assess frequency of and repeating reasons for borrowing Examples Frequent accidental use of incorrect stock exchanging short-dated vaccines or issues with ordering and shipment
Yes [X] No
Goal of this question Determine the reasons why the site is borrowing vaccine
If sites are using the Vaccine Borrowing Report review the reasons for borrowing to help document borrowed VFC andor private doses If they have not been documenting borrowing on this report (or any other form) estimate their borrowing practices If you do not know the date range for their borrowing use the last site visit date to the current visit date The use of ldquootherrdquo as the reported reason for borrowing should be rare if ever and would require explanation and follow up
Helpful information bull Look to see if they routinely maintain insufficient amounts or types of vaccine to support their public and private patients that leads to borrowing
bull Pay attention to borrowing cases documented as ldquoaccidentalrdquo Repetitive accidental borrowing may indicate an issue with ordering processes or insufficient staff training
bull Borrowing is not a place to document wasted or lost doses bull The time period of the borrowing may give you clues about the root cause Were the borrowed doses concentrated in a short period or spread out across several months or a year Are all vaccine types being borrowed or just one
bull If borrowing seems to be an issue discuss vaccine management ordering procedures
Resources bull Vaccine Borrowing Report on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfc formshtml)
bull Section 10 in the MnVFC Policies and Procedures Manual
Page 28 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 36
3 Documentation Vaccine Management Plan
Question 36 Physically review the providerrsquos Vaccine Management Plan to answer the question below
A Does the provider have a Vaccine Management Plan Yes No [X] (If no skip to question 37)
B Does the plan list the current Immunization Manager Vaccine Coordinator andback-up
Yes No [X]
C Does the plan address proper vaccine storage and handling practices Yes No [X]
D Does the plan specify vaccine receiving procedures Yes No [X]
E Does the plan contain procedures for what to do with vaccine in the event of an emergency
Yes No [X]
F Does the plan contain procedures for vaccine ordering Yes No [X]
G Does the plan address inventory control (example stock rotation) Yes No [X]
H Does the plan address how to handle vaccine wastage Yes No [X]
I Does the plan address staff training and documentation on vaccine managementstorage amp handling
Yes No [X]
J Does the plan contain a review date that falls within the last 12 months Yes No [X]
K Has the plan been signed by the individual responsible for its content Yes No [X]
Review CDC Requirement
VFC providers must develop maintain and implement a Vaccine Management Plan for routine and emergency vaccinemanagement The plan must contain the current Vaccine Coordinator and back-up proper storage and handling practicesshipping and receiving procedures emergency procedures procedures for vaccine ordering inventory control (eg stock rotation)how to handle vaccine wastage and staff trainingdocumentation on vaccine management storage and handling The plan must bereviewedupdated annually or more frequently if changes occur A ldquoreview daterdquo and signature are required on all plans in order tovalidate that they are current
Goal of this question Evaluate the sitersquos plan for vaccine management It is especially important that they have a plan for emergency management of their vaccine in the case of equipment failure or power outage Encourage all sites to read and sign the MnVFC Policies and Procedures Manual and complete the emergency plan or be able to show you a plan of their own
If the provider is not able to physically show you the plan at the time of the visit or if the recorded review date is not within the last 12 months you must mark that this requirement is unmet The Vaccine Management Plan is important in times of emergency and it should be easy to access by any staff member at any time Encourage them to post the plan and put a copy with the packing supplies
Helpful information bull Encourage the site to fill in the ldquoImmunization Managerrdquo and ldquoVaccine Coordinatorrdquo fields in the
MnVFC Policies and Procedures Manual for their own referencebull The emergency plan in the manual can be reviewed from last year and included in this yearrsquos manual (with an updated signature and date) if there have not been any changes
bull If information in the plan is outdated site staff will not be well equipped to safely manage vaccines in the event of a power-outage or other emergency situation
bull If their institutional policy is only reviewed and updated every 3-4 years (as many are) the staff may need to sign the MnVFC Polices and Procedure Manual to meet this requirement
Resource Routine Vaccine Management Plan and Emergency Vaccine Management Plan in the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 29
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 37
3 Documentation VIS amp VAERS
Question 37 Review the providerrsquos Vaccine Information Statements (VISs) and discuss providerrsquos VAERS process toanswer the questions below
A Does the provider have readily available up-to-date VISs for all ACIP-recommendedvaccines relevant to the populations it serves
Yes No [X]
B Does the provider make a VIS available for patientsparents before eachvaccination
Yes No [X]
C Does the provider know how and when to report clinically significant adverseevents using VAERS
Yes No [X]
Review CDC Requirement
VFC providers are required to distribute the current Vaccine Information Statements (VIS) each time a vaccine is administered and maintain records in accordance with the National Childhood Vaccine Injury Act (NCVIA) which includes reporting clinicallysignificant adverse events to the Vaccine Adverse Event Reporting System (VAERS) For a list of current VISs visit CDCrsquos Vaccine Information Statements (httpwwwcdcgovvaccineshcpvis) website
Gal of this question Ensure the site has the most current VISs and is giving them to each patientparent before administering the vaccine in compliance with the federal law Parents must be educated about the vaccine their child will receive and be aware of possible contraindications and side-effects in order to make well-informed decisions about their childrsquos health
Helpful information bull Ask to see the sitersquos VISs to determine if they have an active protocol for giving VISs to parents Review to make sure they are current Ask if they know where and how to report vaccine adverse events
Resources bull Section 3 in the MnVFC Policies and Procedures Manual bull CDC Vaccine Information Statements (wwwcdcgovvaccineshcpvisindexhtml) Site may sign up for email updates for the current list of VIS publication dates for the most up-to-date version
bull IAC Itrsquos Federal Law You must give your patients current Vaccine Information Statements (wwwimmunizeorgcatgdp2027pdf)
bull VAERS (httpsvaershhsgovindex)
Question 38
3 Documentation Anaphylaxis protocol
Question 38 Does the site have an anaphylaxis protocol which is clearly posted near the emergency kit
Answers (Choose one)
Yes No [X]
Review CDC Requirement
An anaphylaxis protocol must be clearly posted in the area where vaccines are administered
Goal of this question Make sure site is prepared for a severe allergic or anaphylactic reaction to a vaccine
Resources bull Section 11 in the MnVFC Policies and Procedures Manual bull IAC protocols Child and Teens (wwwimmunizeorgcatgdp3082apdf) and Adults (wwwimmunize orgcatgdp3082pdf)
Page 30 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
i
i i i - li i i i i i l
Section 4 Storage amp Handling Per Unit The goal of this section is to assess vaccine storage
2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet practices in each unit at the site MnVFC PIN ___________________
The 2017 MnVFC Storage amp Handling Per Unit Answer Sheet is a worksheet to document the answers to the questions in this section for each unit (combination or stand-alone) Fill in the answers to the questions in Section 4 on the answer sheet not in the questionnaire
The answer sheet has an abbreviated form of each question If you need further information on that question refer back to the full questionnaire Also if you find an area where the site is not meeting the requirements you will need to go back to that question on the 2017 MnVFC Site Visit Questionnaire to complete ldquoActions if Non- compliantrdquo section including the root cause analysis and follow-up sections If there is a problem in more than one unit make a note on the questionnaire which unit you are referring to in the Notes section
Important You must fully assess any unit that may be used to store VFC vaccines even if there are no VFC vaccines there on the day of the visit If there are no vaccines and the site is not documenting twice a day temperatures discuss the need to ensure the unit is maintaining stable temperatures by monitoring for one week before placing vaccines in the unit
Quest on number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
for the freezer and e co umn
Temperature Monitoring Dev refr gerator f the un
ce Quest ons Quest ons 4 3 4 7 must be answered separate y t s a combo Be sure to document responses n the appropr at
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
44D Data downloaded and reviewed routinely (eg weekly)
Yes No [O]
Yes No [O]
45A Certificate of Calibration Testing Yes No [X]
Yes No [X]
45B Date of calibration
45C Date certificate expires [X] Follow-up is required if expired [X] Follow-up is required if expired
45D Certificate contains all necessary items
Yes No [X]
Yes No [X]
46 Probe properly placed Yes No [X]
Yes No [X]
47A Two temperature readings per day
Yes No [X]
Yes No [X]
47B Time date and name (or initials) for each reading
Yes No [X]
Yes No [X]
47C Current temperature and minmax temperatures (if
Current ________deg Minimum ________deg Maximum _deg
Current ________deg Minimum ________deg Maximum _deg
Sections 5 and 6 contain questions about storage and handling site wide and inventory It is helpful to keep those questions in mind as you assess the individual storage units Think about dorm-style units expired vaccine vaccine supply room for vaccine stocking all the recommended vaccines and separation of stock if appropriate
NOTE The sections that follow require reviewers to validate responses by looking at vaccine storage units temperaturemonitoring equipment and the vaccine inventory inside a unit bull For section 4 use a separate Storage amp Handling Per Unit Answer Sheet for each unit to document the findings (combination
units using both sections can be documented on the same answer sheet) bull When an unmet requirement is identified return to this questionnaire to complete the ldquoActions if Non-compliantrdquo section for
that question bull After you complete one answer sheet for each unit return to the questionnaire to complete sections 5 and 6 using information
you gathered while assessing the units The questions in sections 5 and 6 (Storage amp Handling Site-Wide and Inventory) are notunit-specific but do require that the response be based on a thorough assessment of all the providersrsquo units
4 Storage amp Handling Per Unit
Description On the Storage amp Handling Per Unit Answer Sheet place a name that will allow you or someone else from your program to easily identify this unit in the event of follow-up We recommend using Brand + Location(example Samsung - Room 123) Save each Storage amp Handling Per Unit Answer Sheet with the Brand + Location in the file name
(example SamsungRoom123doc)
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The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 41
4 Storage amp Handling Per Unit Storage Unit Build amp Use
Question 41 Below select the build and use of the vaccine storage unit you are assessing
Note to Reviewer Dorm-style units Do not add dorm-style units here Dorm-style units will be addressed in section 5 Units storing only private stock You must review these storage units even if they contain only private stockat the time of the visit because that vaccine could be administered to VFC patients
A What type of unit is this A Stand-alone B Combination
B Select use if stand-alone A Freezer B Refrigerator
Select use if combination A Use both sections to store vaccine B Use freezer section only to store vaccine C Use refrigerator section only to store vaccine
Goal of this question Identify the unit you are evaluating The description asks you to create a unique name for this unit so that you will be able to identify the same unit in future site visits Put this description on the top of the answer sheet (ie make and location)
Helpful information bull A stand-alone unit is either a refrigerator or a freezer It does not have both sections in the unit bull If there is a combination unit note if the site uses both the refrigerator and freezer or only one section of the unit to store vaccines CDC does not recommend the use of either section or the freezer section only of combination household units
bull If your site utilizes the separate stock method of vaccine management you must review storage units even if they contain only private stock at the time of the visit because there is a chance that those vaccines could be administered (borrowed) to VFC-eligible patients
Page 32 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 424 Storage amp Handling Per Unit CDC Recommended Storage Units
Question 42 Below document the grade of the vaccine storage unit you are assessing
Note to Reviewer Pharmaceutical Also called ldquopurpose-builtrdquo these units are designed by the manufacturer specifically tostore vaccines or other biological materials Commercial Although usually intended to store food and beverages commercial units are often larger and more powerful than the household units found in most homes Though these units are intended to meet thehigher demands of larger facilities these units are not specifically built for the storage of biologicalmaterials Household (non-commercialdomestic) These units are usually smaller than commercial units and areintended for use in small offices and in homes ndash typically for food storage However just like commercialunits they are not designed specifically for the storage of biological materials Such units are usually available in common home supply stores
Answers (Choose one)
Select grade A Pharmaceutical B CommercialHousehold
[O] CDC does not recommend the use of both sections or the freezer section only of combination commercialhousehold units
Review CDC Recommendation
CDC recommends the following vaccine storage unit types (in order of preference) pharmaceutical grade stand-alone orcombination units (preferred) householdcommercial stand-alone units householdcommercial combination units using therefrigerator section only
Goal of this question Assess the grade and type of each storage unit bull Pharmaceutical grade units may be stand-alone or combination units that are often metal may have glass in the door for viewing inside often have an external digital temperature display and are manufactured by medical companies
bull Commercial or household units often look like your kitchen appliance have vegetablemeat drawers in the unit and are manufactured by household appliance companies
bull Occasionally you might find a medical grade unit which is usually a commercialhousehold unit with a lock and 3-prong plug These are still considered household units because of their ability to maintain proper temperatures and air flow Studies show that household stand-alone units are better able to maintain consistent temperatures than their combination counterparts Combination household units used to store vaccine in both sections of the unit is no longer recommended and may be prohibited in the future Combination household storage units that are having difficulty maintaining a cold enough freezer temperature and a warm enough refrigerator temperature should be replaced or a separate stand-alone freezer should be purchased
For frozen vaccines the most cost effective solution is for the site to purchase a small stand-alone freezer The site may need time to budget for a stand-alone storage unit
Resources bull Replacing Combination Household Units Tip Sheet on IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml)
IPI Advisor Manual | February 2017 Page 33
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 434 Storage amp Handling Per Unit Temperature Monitoring Device in the Unit
Question 43 Determine whether there is a temperature monitoring device in this section of the storage unit andanswer the questions
A Is there a temperature monitoring device in this section of thestorage unit
Yes No [X] (If no skip to question 47)
B Who is responsible for supplying the temperature monitoring device in this section of the storage unit Provider
Review CDC Requirement
Certificates of calibration testing provide confidence that the temperature monitoring device is measuring temperaturesaccurately All units storing VFC vaccines must have a calibrated temperature monitoring device with a current and valid certificateof calibration testing All certificates must contain modeldevice name or number serial number date of calibration testing (report or issue date) and Instrument Passed testingInstrument in Tolerance (Recommended uncertainty = +-05ordm C (+-1ordm F))
Goal of this question Assess whether there is a temperature monitoring device in the unit If the unit is not being monitored at all call MDH at 651-201-5522 for guidance
Helpful information bull This question does not ask whether the temperature monitoring device is working or the characteristics of the device These issues will be addressed later in the questionnaire
bull For part B the provider is always responsible for supplying the temperature monitoring device Even if their thermometer or data logger was originally from MDH it is their responsibility to ensure it is functional and calibrated
Resources bull Section 8 in the MnVFC Policies and Procedures Manual
Page 34 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 444 Storage amp Handling Per Unit CDC Recommended Temperature Monitoring Device
Question 44 Assess the temperature monitoring device in this section of the storage unit to answer the questionsbelow
A Is the temperature monitoring device a continuous monitoring and recordingdevice (eg data logger)
Yes No [O] (Skip D)
B Does the temperature monitoring device have a probe in buffered material Yes No [O]
C Does the temperature monitoring device have a digital display that can beeasily read from the outside of this unit
Yes No [O]
D Is data downloaded and reviewed routinely Yes No [O]
Review CDC Recommendation
As of Jan 1 2018 all VFC providers must use continuous temperature monitoring devices (eg data loggers) to monitor vaccinesthat will be administered to VFC-eligible children Routine review and accessibility of temperature data is critical for determining whether vaccine has been properly stored and for assessing usability of vaccine that was involved in a temperature excursion Tomeet VFC Program requirements the device must also be equipped with bull A temperature probe bull An active temperature display that can be easily read from the outside of the unit bull The capacity for continuous monitoring and recording capabilities where the data can be routinely downloaded
The following are additional recommended features for these devices bull Alarm for out-of-range temperatures bull Current minimum and maximum temperatures display bull Low battery indicator bull Accuracy of +- 1degF (05degC) bull Memory storage of at least 4000 readings bull User programmable logging interval (or reading rate) recommended at a maximum time interval of every 30 minutes bull Use of a probe that best reflects the temperature of the vaccine (such as a buffered probe)
Goal of this question Assess the temperature monitoring device in the storage unit Note that these are all recommendations not requirements at this time
This is a great teaching opportunity for sites who do not currently have a continuous temperature monitoring device Beginning Jan 1 2018 all units that store MnVFC vaccine will be required to have a continuous temperature monitoring device (ie a data logger or a continuous temperature monitoring system) Unlike a minmax thermometer a continuous temperature monitoring device provides detailed information on all temperatures recorded at pre-set intervals For excursions it can provide information on when a temperature went out-of-range for how long and what the temperatures were This is essential information that vaccine manufacturers need to know to assess the viability of the vaccine following an excursion
Helpful information bull Sites are required to monitor and record temperatures twice daily however temperature excursions can easily occur in the 12 hours or longer between readings Continuous temperature monitoring can help manufacturers determine vaccine viability
bull Continue to encourage sites to document and evaluate minimum and maximum temperatures the storage unit reached since the last reading and respond appropriately to out-of-range temperatures
IPI Advisor Manual | February 2017 Page 35
The 2017 MnVFC Site Visit Paperwork Chapter 4
bull It is recommended that sites download and review data weekly Discuss with sites that reviewing temperature monitoring device data also includes responding appropriately if they identify out-of-range temps
bull There is sometimes confusion about the difference between a data logger and a continuous temperature monitoring system Here are some differences
Data Loggers Continuous Monitoring Systems Have an external display similar to thermometers May or may not have an external display Have a detachable probe Probe is usually attached to transmitter Need to be plugged into the computer or cradle to download information on a regular schedule
Wirelessly sends data to computer system
Create a file of data that needs to be saved on the computer
Data is stored within the system not a separate file
Doesnrsquot allow documentation of twice a day temperature checks in the file
May allow documentation of twice a day temperature checks within the system
More about the 2018 requirement for a continuous temperature monitoring device
Required Features bull The continuous temperature monitoring device must have Continuous monitoring and recording capabilities to track and record temperatures over time The capacity to routinely download temperature data to a computer (recommended at least weekly) or wirelessly transmit data Detachable probe in a bottle filled with a thermal buffer (eg bio-safe glycol) if the data logger needs to be detached in order to download data Active temperature display
Recommended Features bull MnVFC recommends continuous temperature monitoring devices with Alarm for out-of-range temperatures Accuracy within +-1degF (+- 05degC) Low battery indicator Display of current minimum and maximum temperatures Memory storage of at least 4000 readings User programmable logging intervals (eg the user can set how often the device records the temperature)
Note that these are all currently recommendations not requirements yet
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Page 36 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 45
Goal of this question Ensure the temperature monitoring device is properly calibrated The certificate of calibration testing means that the device has been tested and it is accurately measuring temperatures within established testing limits The certificate of calibration ensures that the device meets all the required components
Helpful information bull The provider is always responsible for having a current certificate of calibration (or copy) on-site
bull To be considered ldquovalidrdquo a certificate of calibration must contain these required elements Modeldevice name or number Serial number
4 Storage amp Handling Per Unit Certificate of Calibration Testing
Review CDC Requirement
Certificates of calibration testing provide confidence that the temperature monitoring device is measuring temperaturesaccurately All units storing VFC vaccines must have a calibrated temperature monitoring device with a current and valid certificateof calibration testing All certificates must contain modeldevice name or number serial number date of calibration testing (report or issue date) and Instrument Passed testingInstrument in Tolerance (Recommended uncertainty = +-05ordm C (+-1ordm F))
Question 45
Note to Reviewer
A
B
C
D
E
Review the certificate of calibration testing for the temperature monitoring device in this section of the storage unit and answer the questions below
bull How to determine certificate of calibration testing expiration date 1) Identify the certificate issuecalibration date 2) Apply the Immunization Program-required frequency for calibration testing Example If the
issuecalibration date is 12312013 and Immunization Program policy requires testing every twoyears the expiration date is 12312015
bull Certificates must include all of the below bull ModelDevice Name or Number bull Serial Number bull Date of Calibration Testing (Report or Issue Date) bull Instrument Passed testing (Instrument in Tolerance)
Is there a certificate of calibration testing for the temperature monitoring Yes device in this section of the storage unit No [X]
What is the date of calibration for the temperature monitoring device in this section of the storage unit
What is the certificatersquos date of expiration based on ImmunizationProgram policy (See note to reviewer to determine expiration date) [X] Follow-up is required if
certificate is expired
Does the certificate contain all the necessary items listed in the Note to Yes Reviewer No [X]
Who is responsible for supplying the current and valid certificate of Provider calibration for this temperature monitoring device
Date of calibration testing (report or issue date) Note If there is no expiration date the certificate expires 2 years from the date of calibration Whether the instrument passed or failed testing (or instrument in tolerancenot in tolerance)
bull Recommended element Documented uncertainty of +- 1degF [05degC]
If these elements are present the certificate is considered valid If the certificate contains information about the recommended element or the entity that issued the certificate that is helpful but not required
To determine if a certificate of calibration testing was issued by an appropriate entity check to see if the certificate indicates one or more of these items (this is the wording used to help sites evaluate if their calibration is accurate but is not required on the certificate itself to be considered valid)
bull Conforms to ISO 17025 bull Performed by an ILACMRA Signatory body accredited laboratory You can review this list of the ILAC MRA and Signatories (httpilacorgilac-mra-and-signatories)
bull Traceable to the standards maintained by NIST bull Meets specifications and testing requirements for the American Society for Testing and Materials (ASTM) Standard E2877 tolerance Class F (le 05 degC) or better
bull Includes reference to another acceptable accuracy validation method such as comparison to other traceable reference standards or tests at thermometric fixed points
Note CDC recommends that certifications be issued for the entire monitoring unit (detachable probe data logger etc) and not individual certificates for each component
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The 2017 MnVFC Site Visit Paperwork Chapter 4
For 45 E the provider is always responsible for supplying the current and valid certificate of calibration for a temperature monitoring device
bull Tip If the temperature monitoring device has a sticker on the back with the calibration date the site can usually call the company who calibrated the device and get a copy of the certificate if they donrsquot have one
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 46 4 Storage amp Handling Per Unit Probe Placement
Question 46 Is the probe properly placed in this section of the storage unit
Note to Reviewer ldquoProperlyrdquo means that the probe in a commercial or household unit is placed in a central area of the unitdirectly with the vaccines Probes should not be placed in the doors near or against the walls close to vents or on the floor of the unit The only allowable exemption related to this requirement is for providerswho have pharmaceutical storage units (built for vaccine storage) that have either (1) a built-intemperature monitoring device OR (2) a dedicated port for the probe that dictates the placement of theprobe
Answers (Choose one)
Yes No [X]
Review CDC Requirement
The probe must be placed in a central area of the section of the storage unit directly with the vaccines in order to properly measurevaccine temperature The probe should not be placed in the door near or against the walls close to vents or on the floor of theunit For pharmaceutical units with a built-in temperature monitoring device or a dedicated port for a probe that is not in thecenter of the section of the storage unit consult your Immunization Program for guidance on placement
Goal of this question Make sure the temperature monitoring device is in the best location to accurately measure the temperature of the vaccines stored in the unit
Helpful information bull The probe of the temperature monitoring device should be placed directly with the vaccines in the middle of the unit The ONLY allowable exception is for pharmaceutical storage units that have either a built-in thermometer or a dedicated port for the probe that indicates placement of the probe
bull Temperatures can vary within the unit especially household units bull Call MDH at 651-201-5522 if you have questions
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Guide (wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml)
Page 38 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 474 Storage amp Handling Per Unit Temperature Documentation
Question 47 Review the temperature documentation over the past three months for this section of the storage unit todetermine whether the provider has a process in place for properly documenting temperatures twice aday Answer the questions below
A Are there two temperature readings recorded for this section of the storage unit per day
Yes No [X]
B Is there a time date and name (or initials) recorded for each reading Yes No [X]
C What is the current temperature and minmax temperatures (if available) inthis section of the storage unit Use the reviewerrsquos thermometer if the providerrsquos temperature monitoringdevice does not have a current valid certificate of calibration testing or the probe is not properly placed in this section of the storage unit
Current Temperature Minimum Temperature Maximum Temperature Fahrenheit Celsius
D Based on your review of the providerrsquos recent temperature documentationincluding the current temperature is this section of the storage unitmaintaining appropriate temperatures
Yes No [X] Not enough information [X]
Review CDC Requirement
Vaccines must be stored under appropriate temperatures as described in the package inserts at all times Acceptable temperature ranges vary by vaccine type and the range is 36deg F and 46deg F (2deg C and 8deg C) and for frozen vaccines the range is -58deg F and +5deg F (shy50deg C and -15deg C) Exposure to temperatures outside of those included in the package inserts could affect vaccine viability andultimately could leave children unprotected against vaccine-preventable diseases In order to maintain awareness of storage unittemperatures and ensure that vaccines are being stored at appropriate temperatures at all times VFC providers are required to monitor and document temperatures for all vaccine storage units at least twice a day Temperature documentation must contain (1) at least two temperature readings per day (2) the time and date of each reading and (3) the name (or initials) of the personwho assessed and recorded the readings CDC also recommends that VFC providers record the minimum and maximumtemperatures of each unit once each workday (preferably in the morning)
Goal of this question Ensure the temperature is being monitored twice daily is within the required range and documented correctly Use your thermometer to check the temperature if the sitersquos temperature monitoring devicersquos probe is not properly placed or there is not a current certificate of calibration Place your thermometer in the unit at the beginning of the visit to allow sufficient time to reach an accurate temperature The purpose of using your thermometer is to ensure the vaccine is being stored at the proper temperature not to ldquovalidaterdquo their reading
Question 47 D is an assessment question based on information you have learned during your visit You might answer ldquonot enough informationrdquo if the unit is new and they donrsquot have at least three months of data or if the unit is only used as overflow and they are inconsistent with temperature monitoring Mark ldquoNordquo if you have reason to believe the storage unit is not maintaining temperatures properly
Helpful information bull All sites must document temperatures twice a day every day the site is open even if they have a data logger or continuous monitoring system
bull Sites can document the information electronically with some continuous monitoring systems as long as it can show what the current temp is the date time and initials of the person checking ndash this needs to be someone at the site ndash not checking remotely or centrally for a large site or system The site must be able to produce these records during their site visit Reviewing these files can be a challenge due to large volumes and lots of paper
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Temperature Logs on Managing Vaccine (wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml)
IPI Advisor Manual | February 2017 Page 39
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 484 Storage amp Handling Per Unit Temperature Excursions
Question 48 In the event that a temperature excursion(s) occurred in this unit within the last three months requestand review documentation of actions taken to determine whether the provider has a process for properlyaddressing excursions Answer the questions below
A Were vaccines in this unit exposed to out-of-range temperatures in the lastthree months (including today)
Yes No (If no skip to question 49)
B Did the provider quarantine and label vaccines as ldquoDo not userdquo Yes No [X]
C Did the provider place vaccine in a unit where it can be stored under properconditions if applicable
Yes No [X]
D Did the provider contact the Immunization Program to report theexcursion
Yes No [X]
E Was the manufacturer contacted for documentation supporting theusability of the vaccine
Yes No [X]
Review CDC Requirement
The provider must document all excursions and actions taken including the following (1) Quarantine and label vaccines as ldquoDO NOTUSErdquo (2) Place vaccines in a unit where they can be stored under proper conditions (3) Contact the Immunization Program to report an excursion and (4) Contact the vaccine manufacturer to obtain documentation supporting the usability of the vaccine
Goal of this question Address any out-of-range temperatures (temperature excursions) identified in reviewing the last three months of temperature logs or during the site visit If there were any out-of-range temperatures did the site respond appropriately to the situation This is a great opportunity to discuss what to do in the event of an excursion The Clinicians Storage and Handling Mishap Checklist is in the IPI Site Visit information folder and is a good review of the process
Helpful information bull Sites need to know that an excursion does not automatically mean that exposed vaccines are non-viable or unusable Exposed vaccines must be quarantined (marked ldquoDo Not Userdquo) and stored under proper conditions until they have received information from vaccine manufacturers regarding the viability of the vaccine
bull Sites must inform MDH when an excursion occurs
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Clinicians Storage and Handling Mishap Checklist (wwwhealthstatemnusdivsidepcimmunize ipivaxchklstpdf)
Page 40 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 49
Goal of this question Ensure proper placement of vaccines in the storage unit
Note These are all recommendations (best practices) not requirements
Helpful information bull Store vaccine in the middle of the compartment two to three inches away from the coils walls floor and cold air vent The temperature near the floor and walls of the unit differs from that in the middle of the compartment and the cold air vent can freeze refrigerated vaccines
4 Storage amp Handling Per Unit Vaccine Placement
Question 49 Look inside the unit to answer the questions below
A Are vaccines placed in the middle of the unit with space between vaccinesand the sideback of the unit to allow cold air to circulate
Yes No [O]
B Are vaccines stored in their original packages Yes No [O]
C Are there water bottles (for refrigerators) or frozen water bottles (forfreezers) in the unit
Yes No [O]
D Are vaccines store in the doors vegetable bins under or near cooling ventsor on the floor of the unit
Yes [O] No
E Is food being stored in the unit Yes [O] No
Review CDC Recommendation
Vaccines should be stored in their original manufacturer (or CDC centralized distributor) packaging They should be placed in the middle of the unit with space between the vaccines and the sideback of the unit to allow cold air to circulate Vaccines SHOULD NOT be stored in the doors vegetable bins or floor of the unit or under or near cooling vents and there should not be any food inthe unit Water bottles (for refrigerators) or frozen water bottles (for freezers) should be placed throughout each storage unit inorder to (1) stabilize or extend temperatures during a power outage and (2) to serve as physical blocks preventing the placementof vaccines in areas of the unit that are at higher risk for temperature excursions (such as in doors vegetable bins floor ornearunder cooling vents)
bull Vaccines should be kept in their original packaging to Protect them from light Help prevent medication errors by making labels easier to read Provide a moisture barrier that serves as insulation in case of an out-of-range temperature power outage door left open or mechanical failure Simplify managing vaccine inventory
bull Store water bottles in the doors on the floor and near the cold air vent in the refrigerator and frozen water bottles in the freezer to help maintain a stable temperature if there is a power failure and when the door is opened frequently Too many water bottles in the door can prevent the door from closing tightly Mark water bottles ldquoDo Not Drinkrdquo
bull Do not store vaccine in the door or drawers of the refrigerator or freezer Vegetable bins and crisper drawers should be removed from refrigerators or used to store other medical supplies or water bottles
bull If vaccine is stored in a household combination refrigeratorfreezer The top shelf should not be used for storing vaccine because the cold air vent blowing from the freezer will freeze vaccine located there If you must use the top shelf of this type of unit place water bottles underneath the cold air vent to prevent vaccine from being stored there It is recommended that only the refrigerator be used for vaccine storage and a separate stand-alone freezer be used to store frozen vaccine
bull Must not store food or beverages in the refrigerator or freezer because frequent opening of doors can lead to temperature variations that may affect vaccine viability There is also a risk of contaminating vaccines
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Guide (wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml) bull Vaccine Storage Tip Sheet on IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml)
IPI Advisor Manual | February 2017 Page 41
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 4104 Storage amp Handling Per Unit Disconnection from Power Source
Question 410 Ask the provider to demonstrate what measures are taken to ensure that vaccine storage units are notaccidentally physically disconnected from the power supply Which of the following describes the measure(s) taken on this unit
Note to Reviewer bull Large hospitals and healthcare systems may not have the ability to demonstrate labels on plugs or circuitbreakers In such cases verify that the practice has a comprehensive policy and standard operatingprocedures in place to prevent the vaccine storage unit from being physically disconnected from thepower supply
bull While back-up generators may ensure power to the overall facility this question ONLY addresses thevaccine storage unit being accidentally disconnected from the power source either through the plug orthe circuit breaker
Answers A ldquoDo not disconnectrdquo labels on the plug (Choose all that B ldquoWarningrdquo label on the circuit breaker box
apply) C Hard-wired (ie built-in) and has a ldquoDo not disconnectrdquo label on thecircuit breaker box D Hospital or large health care system with a comprehensive written policyand standard operating procedures detailing measures taken to preventvaccine storage units from being accidentally disconnected from the powersupply E No acceptable measures for preventing accidental disconnection frompower supply [X]
[X] The response is non-compliant if only A only B or E is selected
Review CDC Requirement
VFC providers must take steps to protect the power source for all vaccine storage equipment by means of having clear warninglabels on both the plug and the circuit breaker associated with all vaccine storage units Large hospitals and healthcare systems canmeet this requirement by demonstrating that they have comprehensive policies and standard operating procedures to preventvaccine storage units from being physically disconnected from the power supply
Goal of this question Decrease the chance that a vaccine storage unit will be accidently unplugged or power will be turned off while vaccine is in the unit This question addresses only what measures the site has taken to ensure the storage unit is not physically disconnected from its power source
If the site uses labels on the plugs and circuit breakers perform a visual inspection to assess whether the way the stickers are positioned make it clear and obvious to anyone that these units are not to be disconnected
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Do Not Unplug and Warning stickers are included in the folder or available to order on the For
Professionals Order Form (wwwhealthstatemnusdivsidepcimmunizeordermathtml)
Note Once you have completed the 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet for each unit return to the questionnaire to complete sections 5 and 6
Page 42 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
- -
Section 5 Storage amp Handling Site-Wide Question 51
5 Storage amp Handling Site Wide Discussion of Cost amp Quantity of Vaccine
Question 51 Have a discussion with the provider about the cost and quantity of VFC vaccines they are responsible for annually Address the points listed in the note to reviewer below
Note to Reviewer bull Vaccine Shipped (Required) Share the cost of VFC vaccines shipped to the provider in the last calendaryear to make sure the provider understands the contribution made by the VFC Program to their practiceFor new providers who do not have ldquocalendar yearrdquo data share either the actual cost of their currentinventory or use the cost of 10 VFC doses of each of the ACIP-recommended vaccines (approximately $7000) to help estimate their annual cost
bull Storage amp Handling (Required) Make sure the provider understands the cost of vaccines for which they are responsible when they make decisions about purchasing recommended vaccine storage and temperature monitoring equipment
Answer I have discussed with the provider the cost and quantity of vaccines ordered in the previous calendar year
Goal of this question Inform sites of the quantity and value of vaccines that they receive as part of the MnVFC program Providers often donrsquot realize the value of the vaccine in their unit This information is included on your clinic list and on the one page site-specific information
Helpful information bull This discussion must occur and the box on the questionnaire must be checked bull If there isnrsquot actual vaccine value information available tell the site that one vaccine order that includes a box of each of the ACIP recommended vaccines costs approximately $7000
bull MDH may not have specific information for individual sites if they receive vaccine from a central warehouse or pharmacy For those sites MDH will give you numbers for the whole system so you can discuss system wide data as appropriate If individual site information is also included it is usually just varicella-containing vaccines that must be shipped directly to the site
Question 52
5 Storage amp Handling Site Wide Dorm Style Units
Question 52 Determine whether the provider has any dorm-style units on site and answer the questions below
Note to Reviewer A dormitory-style refrigerator is a unit that has both refrigerator and freezer compartments behind a singleexterior door Dorm-style units also have an evaporator plate (cooling coil) which is usually located insidean icemaker compartment (freezer) within the refrigerator
A Does the provider have any dorm-style units that are used at any time tostore vaccines
Yes [X] No (Skip to question 53)
B Does the provider have sufficient space in existing compliant vaccinestorage units to store all vaccines without use of the dorm-style unit at any time
Yes No [X]
Review CDC Requirement
Dorm- and bar-style units are prohibited for vaccine storage Vaccines stored in dorm-style units are considered non-viable and must be returned to the centralized distributor CDC recommends the following vaccine storage unit types (in order of preference)pharmaceutical grade stand-alone or combination units (preferred) householdcommercial stand-alone unitshouseholdcommercial combination units using the refrigerator section only
Goal of this question Ensure no vaccine is stored in dorm-style units even for short periods of time Encourage them to label any units ldquoNo Vaccine Storage Allowedrdquo Vaccine stored in these units is considered non-viable If a site is using a dorm-style unit call the MnVFC program (651-201-5522)
Resource Section 8 in the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 43
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 535 Storage amp Handling Site Wide Storage Unit Space Availability
Question 53 Does the provider have sufficient room across storage units to store current stock as well as anyadditional stock acquired during peak season without overcrowding
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have sufficient storage space to accommodate vaccine stock at the busiest time of year without overcrowding
Goal of this question Ensure that sites have sufficient space in their units to maintain vaccines at the busiest time of year Overcrowding of vaccine limits air circulation and affects the unitrsquos ability to maintain stable temperatures
Helpful information bull Look for signs of overcrowding such as vaccines that are pushed up against the wall bins that are overflowing or storage units that are full during non-peak seasons
Discuss immediate actions if the unit is overcrowded Move some of their vaccines order less vaccine more frequently (once per month preferably) andor purchase another storage unit for overflow
Resource bull Section 8 MnVFC Policy and Procedure Manual
Page 44 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 545 Storage amp Handling Site Wide Expired Vaccines
Question 54 Look in each unit Are there expired vaccines in any of the vaccine storage units at this site
Answers (Choose one)
Yes [X] No
Review CDC Requirement
Vaccines should be rotated weekly and when a new shipment comes in so that longer-dated vaccines are stored behind shorter-dated vaccines If vaccines expire they can no longer be stored in the same storage unit with viable vaccines They must be placedin a container or bag clearly labeled ldquoDo not userdquo and separated from viable vaccines to prevent inadvertent use Expired vaccinemust be returned to the centralized distributor within six months of expiration
Goal of this question Ensure there is no expired vaccine in any storage unit
Helpful information bull Sites can prevent their stock from expiring by rotating vaccines every week andor when a new shipment arrives Longer-dated vaccines are stored towards the back of the unit and shorter-dated vaccines are up front
bull Pay attention to vaccines that expire within the next three months Consider transferring vaccine that will expire soon to another MnVFC-enrolled site that will use the vaccine preferably a site close by It is the transferring sitersquos responsibility to arrange the transfer of the vaccine Be sure to complete the MDH Vaccine Transfer Record form and send it to MDH If they are having difficulty finding a location to accept vaccine contact MDH
bull This is a great opportunity to educate sites about the MDH Nonviable Vaccine Form and the process for returning vaccine The VFC program does get some credit for taxes and fees on vaccine that is returned to the distribution center
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MDH Nonviable Vaccine Form and MDH Vaccine Transfer Record on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfcformshtml)
IPI Advisor Manual | February 2017 Page 45
The 2017 MnVFC Site Visit Paperwork Chapter 4
- -
-
Question 555 Storage amp Handling Site Wide Back up Thermometer
Question 55 Does the provider have a readily available back-up thermometer with a current and valid certificate ofcalibration testing
Note to Reviewer ldquoReadily availablerdquo means that the thermometer is available to perform twice-a-day monitoring for a unit asrequired CDC recommends that the back-up thermometer be maintained on site
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have a readily available back-up thermometer with a current and valid certificate of calibration testing Toprevent the certificates of calibration testing of the primary and back-up thermometers from expiring at the same time the date of calibration testing (or issue date) of the back-up thermometer should be different from the date of calibration testing (or issue date) of the primary thermometer As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meetsVFC program requirements
Goal of this question Ensure sites have one calibrated back-up thermometer onsite that is readily available in the event that the temperature monitoring device in unit fails transportation of vaccine is needed or there are other unexpected circumstances
Helpful information bull As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meets VFC Program requirements
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 56 5 Storage amp Handling Site Wide Preparation of Vaccine
Question 56 When does this provider prepare vaccine for administration to the patient
Note to Reviewer For mass vaccination clinics if one type of vaccine is offered providers may pre-draw up to 10 doses Ifusing pre-filled syringes pre-drawing also means activating the syringe by removing the needle guard orattaching a needle
Answers (Choose all that
apply)
Prepare dose immediately before administration Pre-draw doses for upcoming patients (in a regular clinicpractice) [O] Pre-draw up to 10 doses (in a mass-vaccination clinic) Pre-draw more than 10 doses (in a mass-vaccination clinic) [O] Other [O]
Review CDC Recommendation
CDC recommends preparing vaccines immediately prior to administration in order to assure viability of vaccine and prevent vaccinewastage Vaccines that are not administered immediately are at risk of exposure to temperatures outside of the required rangewhich can affect vaccine viability and ultimately can leave children unprotected against vaccine-preventable diseases
Goal of this question Discuss proper timing and preparation of vaccine(s) for administration These are recommendations not requirements
Helpful information bull Educate staff on the importance of preparing vaccine immediately before administration Pre-drawing of vaccines may lead to concerns related to vaccine viability potency sterility and wastage
Page 46 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 6 Inventory Question 61
6 Inventory Inventory Comparison
Question 61 Visually inspect storage units to determine if existing supply of vaccines proportionately mirrorspopulations served Choose the most accurate statement below
Note to Reviewer bull CDC recommends that providers maintain a four-week supply of inventory bull For this question do not take into account vaccine types that the provider does not order Here simply
make sure that overall the vaccines in the providerrsquos storage units are available in sufficient amounts toserve their patient population
Answers (Choose one)
The current vaccine inventory proportionately reflects the populations identified Only public stock is insufficient [X] Only private stock is insufficient [X] Both public and private stock are insufficient [X] Site uses the replacement method but does not appear to have enough vaccine for their population [X] Other [X]
Review CDC Requirement
VFC providers must order and stock routine vaccines in accordance with their patient population in order to prevent missedvaccination opportunities Having sufficient amounts of all stocks prevents the inadvertent use of VFC vaccines for non-VFC-eligiblepatients and vice versa
Goal of this question Assess whether the site is ordering appropriate quantities of vaccine for the population they serve at their site
Helpful information bull If the site sees 30 percent private-pay patients and 70 percent VFC the stock in their storage units should reflect that proportion If you donrsquot know you can ask the site about their population
bull This is meant to be a general assessment so in a big site if they have only a small amount of vaccine that may indicate an issue with vaccine management
bull CDC recommends smaller more frequent orders (ie monthly) rather than large orders to minimize the amount of vaccine loss if an incident occurs during shipment or in the storage unit Sites should not order more frequently than once a month
bull Sites using the replacement method will only have one stock but it should appear to be large enough for their population
bull Only assess the vaccine types that the site currently stocks in their unit We know there are sites that do not offer all ACIP-recommended vaccines for various reasons That issue will be addressed in question 62
IPI Advisor Manual | February 2017 Page 47
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 626 Inventory ACIP Recommended Vaccines
Question 62 Review providerrsquos current inventory to answer the questions below
A Does the provider offer all routine ACIP-recommendedvaccines for their patient population
Yes (Skip to question C) No [X] Offers all except varicella because direct ship ofvaccine is unavailable from manufacturer
B Which routine vaccines are NOT being offered DTaP Hepatitis A Hepatitis B HIB HPV Influenza Meningococcal
MMR Pneumococcal Polio Rotavirus TdapTd Varicella
C According to Immunization Program Policy does theprovider make accessible all non-routine ACIP-recommended vaccines for those VFC patients whomeet the criteria for receiving them
Yes (Skip to question 63) No [X]
D Which non-routine vaccines are NOT being offered Pneumococcal polysaccharide vaccine (PPSV23) Meningococcal Group B (MenB) Other
Review CDC Requirement
VFC providers agree to comply with immunization schedules dosages and contraindications that are established by the Advisory Committee on Immunization Practices (ACIP) for the vaccines identified and agreed upon in the Provider Agreement UNLESS bull In the VFC providers medical judgment and in accordance with accepted medical practice the VFC provider deems such
compliance to be medically inappropriate for the child bull The particular requirements contradict state law including laws pertaining to religious and other exemptions The VFC program entitles children to the following vaccines DTaP Hepatitis A Hepatitis B HIB HPV Influenza MeningococcalMMR Pneumococcal Polio Rotavirus TdapTd and Varicella VFC providers are also required to ensure that VFC-eligible children have access to non-routine vaccines as needed
Goal of this question Assess if the site is offering all the ACIP-recommended vaccines for the population they serve and these vaccines are in stock on the day of the visit It is important that every MnVFC-eligible child that comes to a providerrsquos office for an immunization is vaccinated
Helpful information bull The Advisory Committee on Immunization Practices (ACIP) is a group of medical and public health experts that develops recommendations on how to use vaccines to control diseases in the United States
bull Specialty providers are not required to offer all routine vaccines but should provide the vaccines appropriate for their population
bull If the site does not offer all routine ACIP-recommended vaccines appropriate for their population check the ldquoNordquo box in Part A then check the appropriate box(es) in Part B for any vaccines not offered Please contact MDH as this situation offers us the opportunity to provide education to the site
bull For non-routine vaccines they must either be in stock or the site must have an alternative protocol in the routine management plan that ensures these children have access when applicable
Resources bull IAC Diseases and Vaccines (wwwimmunizeorgvaccines) bull CDC Advisory Committee on Immunization Practices (ACIP) (wwwcdcgovvaccinesacipindexhtml)
Page 48 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 636 Inventory Separation of Stock
Question 63 Observe how the provider differentiates stock in each storage unit to answer the questions below
A Is it clear which vaccines belong to public stock andwhich belong to private stock
Yes No [X] Not applicable replacement site
B Is it clear which vaccines belong to VFC stock andwhich belong to UUAV stock
Yes No [X] Not applicable replacement site Not applicable not UUAV-enrolled site
Review CDC Requirement
In order to ensure that VFC vaccines are only administered to VFC-eligible children VFC providers that serve both VFC and non-VFCshyeligible children must maintain their vaccine inventories in such a way that they can clearly differentiate public stock from privatestock as well as VFC from other public stock
Goal of this question Assess whether the site can distinguish between MnVFC vaccine and private vaccine If they participate in the Uninsured and Underinsured Adult Vaccine (UUAV) program they should also be able to distinguish between MnVFC stock and UUAV stock Some sites use labels bins boxes etc to differentiate their stock If it is not clear how the site differentiates their stock discuss vaccine management with the staff For follow-up call MDH to discuss doing a follow-up site visit
Sites using the replacement method will not have separate stocksmdashthis is an approved alternative method for keeping track of vaccine
Resource bull Section 10 of the MnVFC Policy and Procedure Manual
IPI Advisor Manual | February 2017 Page 49
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
MnVFC Site Visit Storage and Handling Per Unit Answer Sheet 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet MnVFC PIN ___________________
Question number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
Temperature Monitoring Device Questions Questions 43 47 must be answered separately for the freezer and refrigerator if the unit is a combo Be sure to document responses in the appropriate column
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
All the questions on the Site Visit Storage amp Handling Per Unit Answer Sheet have been discussed previously in section 4 of this manual Use this sheet to record information about all the units at the site visit You will need one sheet for each unit If it is a combination unit (either pharmaceutical or household) you can record both sections on one sheet If they have stand-alone units use one sheet for each unit Do not enter the answers to the questions in section 4 of the questionnaire
If you need more information about any of the questions refer back to the main questionnairemdashthe complete question additional guidance including notes to the reviewer and the CDC requirements are there Also if the site is not meeting the requirement you will go back to the questionnaire to complete the ldquoActions if Non-compliantrdquo section including the root cause analysis and follow-up sections
When you have completed the assessment of all the storage units remember to go back to the questionnaire to complete sections 5 and 6
Page 50 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
ndash
ndash
MnVFC Provider Follow-up PlanThe goal of the Provider Follow-up Plan is to communicate with the site all of the VFC requirements any unmet requirements found during your site visit and the timeline for completing the required action The left hand column is a box to check for ldquoUnmetrdquo requirements
Helpful information bull The form can be used to review what the site is doing well and what they need to work on
bull For requirements that have specific documentation that needs to be sent to you use the notes section
2017 MnVFC Provider Follow-up Plan Site _______________________________________________ MnVFC PIN ____________ Date of Visit ___________
Thank you for participating in this MnVFC compliance site visit Please review this visit summary including follow-up actions and timelines for completion Unmet MnVFC requirements and recommendations have a checked box next to them The goal of this plan is to support you with successfully implementing the program and improving access to vaccines for VFC-eligible children
Unmet Question VFC Requirements Section 1 Changes to Key Staff
Q12 Change in the Medical Director Immunization Manager Vaccine Coordinator or back-upKey Staff must be communicated to the immunization program by emailing healthmnvfcstatemnus Changes Notes
Q12 Key staff must complete the annual training on VFC program requirements and print theAnnual Training certificate of completion Documentation Required Action
Staff that have not completed the MnVFC online training must complete it and send acopy of the certificate to the reviewer Training can be found on the MnVFC website (wwwhealthstatemnusvfc) Due date 1 month
Notes
Unmet Question VFC Requirements Section 2 Eligibility
Q21 Provider staff must possess a working knowledge of all VFC eligibility criteria and use thoseVFC Eligibility criteria to screen children prior to administering VFC vaccines
Categories Notes
bull This form provides documentation needed for follow-up actions when you send your thank you email
The second to last page of the Provider Follow-up Plan has a summary of the MnVFC program recommendations These are to remind the site about best practices they may want to improve upon even though they are not yet requirements of the program For example you could discuss the recommendation about storage units if they currently have a combination household unit and are using both sections
The last section is for your signature and the person you met with In most sites it will be the immunization manager or vaccine coordinator who signs the form unless the medical director attended the site visit You keep the original copy and the site will need to keep a copy for themselves
To be completed by the site visit reviewer
I acknowledge that a VFC site visit was performed on __________________ (visit date) The follow-up plan which includes a list of all current VFC program requirements and recommendations assessed during the visit and any required follow-up actions was provided at the end of the visit
Site visit reviewer
Phone
Reviewer Signature Date
To be completed by the provider
I acknowledge that our practice took part in the VFC site visit noted above I understand the findings of the visit and any required actions that must be taken by our office in order to meet VFC program requirements
Medical Director (or designee) Name Title
Medical Director (or designee) Signature Date
IPI Advisor Manual | February 2017 Page 51
The 2017 MnVFC Site Visit Paperwork Chapter 4
After the Site Visit Send a thank you email highlighting the unmet requirements documents you need from the site to resolve the issue(s) and the date you need them Make sure to include the link to the Site Visit Survey (httpssurveyvovicicomseashxs=56206EE334CE0B14)
Please refer to Chapter 3 for more information about future follow-up required after the visit including forms and documentation
Resource bull Sample Thank You letter on IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml)
Chapter 5
IPI Advisor Resource List MnVFC Program 651-201-5522
MnVFC wwwhealthstatemnusvfc
bull Separate Stock and Replacement Method Policies and Procedures Manuals bull Online trainings bull MnVFC Announcements sign up to receive them via email bull Ordering MDH vaccine bull MnVFC forms Screening forms Reporting forms Others MDH Nonviable Vaccine Form MDH Vaccine Transfer Record and Vaccine Borrowing Report
bull MnVFC promotional materials bull Immunization Billing Guidance for MnVFC and Immunization Billing Guidance for MnVFC Replacement Sites Immunization Practices Improvement Program (IPI) wwwhealthstatemnusdivsidepcimmunizeipi
bull IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml) bull IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml) IPI Resource Folder Contents (wwwhealthstatemnusdivsidepcimmunizeipiipifolderpdf)
Minnesota Immunization Information Connection (MIIC) wwwhealthstatemnusmiic
bull MIIC regions and regional coordinators
Clinical Practice MDH Immunization Program wwwhealthstatemnusimmunize
Got Your Shots News wwwhealthstatemnusdivsidepcnewslettersgys
MDH Immunization Information for Health Care Providers wwwhealthstatemnusdivsidepcimmunizehcp
bull Got Your Shots A Providers Guide to Immunization in Minnesota bull Vaccine protocols bull Forms for tracking patient immunizations bull Immunization schedules for Health Care Providers Immunization Action Coalition (IAC) wwwimmunizeorg
bull Ask the Experts bull VISs (Vaccine Information Statements and translations) bull Administration screening questions bull Medical management of vaccine reactions bull Order form for Californiarsquos Immunization Technique DVD Best Practices with Infants Children and Adults
Page 52 IPI Advisor Manual| February 2017
IPI Advisor Resource List Chapter 5
CDC ldquoPink Bookrdquo wwwcdcgovvaccinespubspinkbookindexhtml
CDC Advisory Committee on Immunization Practices (ACIP) wwwcdcgovvaccinesacip
CDC Vaccines and Immunizations wwwcdcgovvaccines
VAERS reporting httpvaershhsgovindex
Storage and Handling Got Your Shots Providers Guide ndash Managing Vaccine wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml
MnVFC Guide to Temperature Monitoring Devices wwwhealthstatemnusvfc
MDH Clinicianrsquos Vaccine Mishap Checklist wwwhealthstatemnusdivsidepcimmunizeipivaxchklstpdf
MDH Vaccine Storage Guide wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml
CDC Vaccine Storage and Handling Toolkit wwwcdcgovvaccinesrecsstoragetoolkit
You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Vaccine manufacturer phone numbers wwwcdcgovvaccinespubspinkbookdownloadsappendicesFcontact-info-manufactpdf
IAC Checklist for Safe Vaccine Handling and Storage wwwimmunizeorgcatgdp3035pdf
IAC Donrsquot Be Guilty of These Errors in Vaccine Storage and Handling wwwimmunizeorgcatgdp3036pdf
Additional Resources Print materials from MDH ndash order forms wwwhealthstatemnusdivsidepcimmunizeordermathtml
Vaccine Education Center ndash Childrenrsquos Hospital of Philadelphia wwwchopeduservicevaccine-education-centerhomehtml
California Department of Public Health ndash Interactive training on vaccine administration and storage and handling handout on transporting vaccine and how to package wwwezizorg
IPI Advisor Manual | February 2017 Page 53
IPI Advisor Resource List Chapter 5
CDC vaccine price list wwwcdcgovvaccinesprogramsvfcawardeesvaccine-managementprice-listindexhtml
Vaccine Information Statements (VIS) wwwcdcgovvaccineshcpvisindexhtml
CEU Opportunities CDC Immunization Education and Training wwwcdcgovvaccinesedindexhtml
Immunization You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Page 54 IPI Advisor Manual| February 2017
- Introduction
-
- Welcome to the Immunization Practice Improvement (IPI) Program
- Contact Information
-
- Chapter 1
- Requirements to Participate in the MnVFC Program
- Vaccines for Children Program
- Chapter 2
- Reimbursement for MnVFC Visits
- Types of Visits
- Your MnVFC Clinical CoordinatorPlanner
- New IPI Advisor Training Requirements
- Your Role as an IPI Advisor
- Reasons MDH Would Do All or Part of a Visit
- Chapter 3
- Future follow-up
- Conducting the Visit
- Preparing for the Visit
- Information for the Visit
- Site Visit Checklist
- Scheduling the Visit
- Chapter 4
- After the Site Visit
- MnVFC Provider Follow-up Plan
- MnVFC Site Visit Storage and Handling Per Unit Answer Sheet
- Section 6 Inventory
- Section 5 Storage amp Handling Site-Wide
- Section 4 Storage amp Handling Per Unit
- Section 3 Documentation
- Section 2 Eligibility
- Section 1 Provider Details
- The Site Visit Reviewer Legend
- MnVFC Site Visit Questionnaire
- Required Paperwork for Site Visits
- Chapter 5
-
Table of Contents
Introduction 3
Welcome to the Immunization Practice Improvement (IPI) ProgramHelpful DefinitionsContact Information
Chapter 1 The Immunization Practices Improvement Program5
Vaccines for Children ProgramRequirements to Participate in the MnVFC Program
Chapter 2 IPI Advisors7
Your Role as an IPI Advisor New IPI Advisor Training Requirements Your MnVFC Clinical CoordinatorPlanner Types of Visits Reimbursement for MnVFC VisitsReasons MDH Would Do All or Part of a Visit
Chapter 3 Site Visits11
Scheduling the Visit Site Visit Checklist Information for the VisitPreparing for the VisitConducting the VisitFuture follow-up
Chapter 4 The 2017 MnVFC Site Visit Paperwork 17
Required Paperwork for Site VisitsMnVFC Site Visit QuestionnaireThe Site Visit Reviewer LegendSection 1 Provider DetailsSection 2 EligibilitySection 3 DocumentationSection 4 Storage amp Handling Per UnitSection 5 Storage amp Handling Site-WideSection 6 Inventory MnVFC Site Visit Storage and Handling Per Unit Answer SheetMnVFC Provider Follow-up PlanAfter the Site Visit
Chapter 5 IPI Advisor Resource List 52
Introduction
Welcome to the Immunization Practice Improvement (IPI) Program IPI is a component of the immunization program at the Minnesota Department of Health IPI merges key aspects of the overall immunization program at the provider level vaccine management vaccine accountability and clinical immunization practices
As an IPI advisor you will be conducting visits to sites that provide vaccines to children through the Minnesota Vaccines for Children (MnVFC) program
This manual along with the appropriate MnVFC Policies and Procedures Manual for the type of site you are visiting will provide you with the information that you need to complete these visits
The most up to date version of this manual is available on the IPI Program Resources (wwwhealth statemnusdivsidepcimmunizeipiresourceshtml) website Changes and additions will be included as they occur
By performing site visits you help ensure that children in Minnesota receive safe viable immunizations and are protected from vaccine-preventable diseases Thank you
Helpful Definitions Sites In this manual all organizations that administer vaccine to MnVFC-eligible children andor store vaccine for MnVFC-eligible children will be referred to as sites
Separate stock Method of vaccine management where sites keep privately-purchased vaccine in a separate stock from MnVFC vaccine obtained through MDH Patients eligible for MnVFC must receive vaccine from the MnVFC stock
Replacement method Method of vaccine management where sites use privately-purchased vaccine to vaccinate MnVFC-eligible children and then the MnVFC program replaces the private vaccine that was administered Only sites with grandfathered status and who have a signed replacement method agreement are allowed to use the replacement method
Parent site A parent site is a location where vaccine is ordered and delivered to be redistributed to satellite sites It is based on how the system is set up for ordering vaccine in the MnVFC ordering software This may or may not be how the site is structured as an organization The parent site orders all the vaccines for the other sites except for varicella-containing vaccines Varicella-containing vaccine must be delivered directly to the site where it will be used The parent site is responsible for the MnVFC Annual Report for itself and all of its satellite sites
Satellite site A satellite site is a site that receives redistributed vaccine from a parent site All satellite sites need to have an enrollment visit and a PIN number to receive MnVFC vaccine from the parent site Sites that are considered a satellite of another site usually have a letter at the end of the PIN to indicate that they are a satellite All vaccines except varicella-containing vaccines are ordered by the parent site for the satellite site Varicella-containing vaccines are ordered using the satellite PIN and are delivered directly to the satellite site Sites must sign a separate provider agreement for each satellite site that stores MnVFC vaccine
IPI Advisor Manual | February 2017 Page 3
Introduction cont
Federally Qualified Health Center (FQHC) A site that is located in an area of need of services Sites apply to receive this federal designation They offer a sliding scale for patients that are uninsured
Rural Health Center (RHC) A site that is located in an underserved rural area They apply to receive this federal designation
Local Public Health (LPH) Clinics are deputized in Minnesota to allow vaccination of underinsured children at their site
Contact Information Immunization Practices Improvement (IPI)
Email healthIPIinquiriesstatemnus
Website wwwhealthstatemnusdivsidepcimmunizeipiindexhtml
Minnesota Vaccine for Children (MnVFC) Program
Phone 651-201-5522
Website wwwhealthstatemnusvfc
Minnesota Department of Health 625 N Robert St (street address) PO Box 64975 (mailing address)St Paul MN 55164-0975
Page 4 IPI Advisor Manual | February 2017
Chapter 1
The Immunization Practices Improvement Program The goal of the Immunization Practices Improvement (IPI) Program is to help ensure that all eligible children receive viable vaccine at low or no cost
The Minnesota Department of Health (MDH) contracts with local public health departments to provide IPI services in their community IPI advisors from these departments complete site visits at MnVFC- enrolled sites in their county Local public health (LPH) staff often already have a relationship with primary care providers in their community and if not visits may help facilitate building relationships and sharing information Visits ensure enrolled sites meet the following objectives
bull Adhere to MnVFC eligibility and programmatic requirements and recommendations bull Manage vaccines to ensure proper storage and handling and minimize waste bull Administer and document vaccines according to current immunization guidelines
Vaccines for Children Program The Vaccines for Children (VFC) Program is a federal entitlement program which provides vaccines to children whose parents or guardians may not be able to afford them This helps ensure that all children have a better chance of getting their recommended vaccinations on schedule Vaccines available through the VFC Program are those recommended by the Advisory Committee on Immunization Practices (ACIP) (wwwcdcgovvaccinesacipindexhtml) These vaccines protect babies young children and adolescents from 16 diseases
Funding for the VFC program is approved by the Office of Management and Budget (OMB) and allocated through the Centers for Medicare amp Medicaid Services (CMS) to the Centers for Disease Control and Prevention (CDC) CDC buys vaccines at a discount and distributes it to grantees (ie state health departments) who then distribute the vaccine at no charge to enrolled sites
History of the Vaccines for Children Program
From 1989 - 1991 a measles epidemic in the United States resulted in tens of thousands of cases of measles and hundreds of deaths Upon investigation CDC found that more than half of the children who had measles had not been immunized even though many of them had seen a health care provider
In partial response to that epidemic Congress passed the Omnibus Budget Reconciliation Act (OBRA) on Aug 10 1993 creating the Vaccines for Children (VFC) Program VFC became operational Oct 1 1994 Known as section 1928 of the Social Security Act the VFC Program is an entitlement program (a right granted by law) for eligible children age 18 and younger
Minnesota Vaccines for Children Program
The Minnesota Vaccines for Children (MnVFC) program is Minnesotarsquos version of the federal VFC program By collaborating with over 820 sites throughout Minnesota MnVFC provides vaccines at no cost to children who may not otherwise be vaccinated because of the inability to pay Approximately one-third of Minnesota children are eligible for the MnVFC program These are children who are 18 years of age or younger and fall into one of the following categories
IPI Advisor Manual | February 2017 Page 5
The IPI Program Chapter 1
bull Uninsured bull Enrolled in a Minnesota Health Care Program Medical Assistance (MA) or MinnesotaCare bull American Indian or Alaskan Native or bull Underinsured children that are seen at a local health department Federally Qualified Health Center (FQHC) or Rural Health Center (RHC) Indian Health Services (IHS) and tribal health clinics
The majority of pediatric and family practice clinics are enrolled in MnVFC so children can stay with their health care home and still receive low-cost immunizations
When Congress enacted the VFC program they wanted to ensure that bull Sites manage their VFC vaccine appropriately so that there is little to no wastage of this valuable asset bull All eligible children receive the vaccine bull Immunization coverage rates increase by removing barriers to vaccination especially among high-risk children and by reducing disparities in access to health care
bull Vaccine is not used for the purpose of gaining profit for the provider or site
To assure these goals are achieved all states are required to conduct site visits for each enrolled site at least every other year As an IPI advisor you will be conducting the required MnVFC site visits in your county
Minnesota receives approximately $48 million of federally funded vaccine through the MnVFC program each year It is extremely important that these vaccines are managed properly and given only to the individuals that are eligible to receive them
Requirements to Participate in the MnVFC Program Initially providers must go through an enrollment process with MDH to receive vaccine from the MnVFC program This requires filling out the enrollment paperwork meeting the requirements in the appropriate MnVFC Policies and Procedures Manual and having an enrollment site visit by MDH staff
Following enrollment all sites receive their first MnVFC site visit within one year (preferably in 3-6 months) and then a MnVFC site visit at least every other year If you know of a provider who is not enrolled in the program a new clinic opens or if a site opens a satellite site in your county have them call the MnVFC program at 651-201-5522 to begin the enrollment process
Sites must meet many requirements to receive vaccine from the MnVFC program These requirements are identified in the MnVFC Policies and Procedures Manual There are two versions of the manual one for sites that keep separate stocks of public and private vaccine and another for sites that use the replacement method of vaccine management A copy of the appropriate manual is mailed to each site every fall The immunization manager vaccine coordinator and their back-ups must complete the annual online training based on the method of vaccine management their site uses All of the materials can be found on the MnVFC website (wwwhealthstatemnusvfc) Sites must complete the appropriate reports agreements and online training each year in order to continue to receive vaccine from the MnVFC program
Page 6 IPI Advisor Manual| February 2017
Chapter 2 IPI Advisors Your Role as an IPI Advisor As part of an MDH grant agreement with community health boards MDH contracts with local public health agencies to conduct MnVFC site visits in their county
As an IPI advisor you will be responsible for bull Attending the annual training provided by MDH bull Reviewing your county site visit lists and providing any known updates to your MnVFC clinical coordinatorplanner
bull Conducting site visits completing and submitting paper work within 10 days of the visit bull Following up with sites for unmet requirements identified at MnVFC site visits bull Notifying MDH when new sites open that will be storing and administering immunizations (in order to recruit new providers)
bull Keeping up-to-date with new recommendations and requirements for immunizations as well as the MnVFC program Read and be familiar with MnVFC and IPI web pages Sign up to receive email alerts for these resources by clicking on the red envelope at the top of these pages MnVFC Announcements (wwwhealthstatemnusdivsidepcimmunizemnvfcbfaxhtml) Got Your Shots News newsletter (wwwhealthstatemnusdivsidepcnewslettersgysindex html) Immunization Practices Improvement Program (wwwhealthstatemnusdivsidepc immunizeipiindexhtml)
Be designated as the IPI contact in Workspace (httpsoephealthstatemnusworkspace) for your organization Contact your organizationrsquos Workspace administrator to assign you this role
Annual training
Every spring MDH provides training for IPI advisors This training may be in-person or by webinar All IPI advisors are required to attend training each year to review site visit paperwork hear updates on the MnVFC program and ask questions about the process
Clinic lists
Early in the year MDH will send you a clinic list Your list will include all sites in your county that are enrolled in the MnVFC program The priority column indicates whether the IPI advisor MDH staff or the field epidemiologist should complete the visit Those sites not due for a visit that year will have the next year listed Every active MnVFC site is required to receive a site visit at least every other year You can do visits every year if you would like but this is not required Please review the list and notify your MnVFC clinical coordinatorplanner about any changes
IPI Advisor Manual | February 2017 Page 7
IPI Advisors Chapter 2
Included with the list is a one-page information sheet for each site This contains the sitersquos demographic information vaccine coordinator and immunization manager listed in our records whether they are a separate stock or replacement site and the doses and cost of vaccine they received last year Confirm this information with the site and discuss their vaccine quantity and value as part of the questionnaire during your visit
All site visits must be completed by Sept 30 2017 If you think you will be unable to complete all your visits by then you will need to contact your MnVFC clinical coordinatorplanner to determine how the visit will be completed
New IPI Advisor Training Requirements New IPI advisors need to contact MDH before performing any MnVFC site visits on their own A MnVFC clinical coordinatorplanner will help you prepare to perform site visits They will
bull Guide your training See the Training Checklist for IPI Advisors on the IPI Program Resources (wwwhealthstate mnusdivsidepcimmunizeipiresourceshtml) page
bull Have you shadow them or another experienced IPI advisor on one or two site visits bull Shadow you on a visit or two bull Complete the training document
Your MnVFC Clinical CoordinatorPlanner Your MnVFC clinical coordinatorplanner is a MDH staff member that will help support you See who your clinical coordinatorplanner is on IPI Contact Information (wwwhealthstatemnusdivsidepc immunizeipicontacthtml)
The role of the MnVFC clinical coordinatorplanner bull Provide assistance to IPI advisors bull Perform enrollment visits for new sites that will be administering MnVFC vaccine bull Review MnVFC site visit paperwork for accuracy bull Conduct MnVFC site visits where necessary bull Provide additional education or follow-up with sites bull Provide assistance and guidance regarding MnVFC requirements and recommendations to sites bull Provide training to IPI advisors and staff at MnVFC-enrolled sites bull Field storage and handling incident calls
Types of Visits MnVFC Site Visit ndash also known as the Compliance Visit
CDC requires all state immunization programs to conduct site visits to all VFC providers MnVFC site visits are required every other year but sites can be visited on a yearly basis if needed The site visit objectives are to
Page 8 IPI Advisor Manual | February 2017
IPI Advisors Chapter 2
bull Complete the MnVFC site visit paperwork found on IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml)
bull Provide education about MnVFC program requirements and recommendations to site staff bull Ensure MnVFC program requirements are properly implemented and are being met bull Provide feedback and as necessary execute corrective action bull Follow-up on identified issues bull Notify your MnVFC clinical coordinatorplanner of issues that are not resolved by the due date
Follow-Up Visit
In-person follow-up visits will not be necessary for most MnVFC site visitsmdashonly those where significant issues are identified in the original visit If you are not able to complete part of the initial site visit because you found a storage and handling incident or you found multiple issues that need to be addressed a follow-up visit may be necessary Please contact the MnVFC clinical coordinatorplanner for approval and guidance for conducting a follow-up site visit
Educational Visit
Some sites may need more information and education than you can provide during a normal site visit This may be on topics related to immunizations immunization practices or administration or storage and handling issues These visits go beyond the sharing of pamphlets resources or information that is presented at a site visit Education visits should be conducted with a group and should focus on a topic that is identified during a site visit or requested by site staff Regularly scheduled meetings are not considered educational visits Educational visits need to be approved prior to the visit by the MnVFC clinical coordinatorplanner in order for you to receive reimbursement from the MnVFC program
Unscheduled (Unannounced) Storage amp Handling Visit
Unscheduled (unannounced) visits are not pre-scheduled with the site These visits require different paperwork and focus primarily on the storage and handling portion of a MnVFC site visit The MnVFC program is required to visit 5 percent to 10 percent of enrolled sites as unannounced visits each year Please discuss any unscheduled visits you would like to do with the MnVFC clinical coordinatorplanner You should plan to complete all of your regularly scheduled visits before doing any unscheduled visits
Enrollment Visit
All sites (including satellite clinics) that receive stock or supply MnVFC vaccine must have an enrollment visit that is conducted by MDH staff As an IPI advisor you may be asked to attend the enrollment visit This is an opportunity for you to start your relationship with the site and help with follow-up that may be necessary for the site to receive MnVFC vaccine Newly enrolled sites are scheduled for their first regular site visit within the first year (preferably within 3 to 6 months) and then every other year
IPI Advisor Manual | February 2017 Page 9
IPI Advisors Chapter 2
Reimbursement for MnVFC Visits Local public health agencies are paid for the site visits they conduct MDH will reimburse participating agencies only after we receive all of the required paperwork Paperwork submitted with incorrect or missing information may delay the reimbursement
IPI program reimbursement is processed on a quarterly basis and is processed in the month following each quarter through an electronic transfer of money Your agencycounty IPI advisor contact will receive an email notification of the reimbursement
Reimbursement rates are updated annually and available on the Contracts and Reimbursements (www healthstatemnusdivsidepcimmunizeipicontreimhtml) page
2017 MnVFC Site Visit Reimbursement Rates MnVFC Site Visit $400 Follow-up Visit$150 Education Visit$100 Unscheduled Visit$300
Reasons MDH Would Do All or Part of a Visit MDH may complete site visits or accompany you on a site visit if
bull The site is new to the MnVFC program (enrollment visit) bull The site has known issues or concerns regarding the MnVFC program especially if you are having difficulty resolving these issues
bull The site is refusing a site visit from local public health or yoursquore having a difficult time scheduling a visit
bull The site is part of tribal health or Indian Health Services bull MDH district epidemiologists will perform site visits at local health departments bull A new IPI advisor needs training from MDH staff bull Note MDH district epidemiologists will perform site visits at local health departments
Page 10 IPI Advisor Manual | February 2017
Chapter 3 Site Visits Scheduling the Visit
bull Check the information sheet or contact the site to confirm who the contact person is in charge of the MnVFC program In general this is the immunization manager or vaccine coordinator If the contact is no longer there ask for the person in charge of the sitersquos vaccines or the clinic manager They can usually direct you to the appropriate person You may want to follow a suggested phone script when contacting the site
Sample Phone Script for Scheduling a Visit
ldquoHello My name is _______ I am calling from ________ Health Department May I speak to (contact name) [If not available determine appropriate person to talk to or a better time to call back] I am calling to schedule a MnVFC site visit This visit will involve a review of immunization practices at your site We will look at vaccine administration storage and handling screening for eligibility and documentation of vaccinations It usually takes about two hours for a visit depending on the number of vaccine storage units you have Is there a day or time of day that works best for you
I have a pre-visit worksheet to send to you to help you prepare for the visit It contains information about what I will need at the visit such as temperature logs and immunization documentation information Completing this worksheet prior to me arriving will help the visit be more efficient Is there any other information that I can send to help you prepare for the visit
If you have any questions call me at ________ Thank you for your time and assistance I look forward to working with yourdquo
bull Arrange a date and time for the visit bull Let them know an approximate visit length Visits are usually around two hours long depending on the size of the site the number of vaccine storage units they have or if they have new staff
bull Request that key staff be present at the visit This could include the immunization manager vaccine coordinator immunization staff clinic manager nurse manager billing staff andor medical director
bull Inform your site contact that you will be sending them an email confirmation along with the MnVFC
Pre-Visit Worksheet
Site Visit Checklist Use the Site Visit Checklist on IPI Advisor Site Visit Materials (wwwhealthstatemnusdivs idepcimmunizeipisvmaterialshtml) to make sure all necessary steps are covered
MINNESOTA VA C CI N ES FO R CHI LD REN PROGRAM
Site Visit Checklist Date of visit Time
Site Name PIN
Address
Contact Phone
Complete Before the visit Comments
Review the clinic list Identify and prioritize which sites you will visit
Email or call to schedule a date and time for the visit Ask for the immunization manager or vaccine coordinator
Email appointment confirmation attach Pre-visit Worksheet and provide instructions for returning it prior to the visit (sample email on website) Include length of the visit and which staff should be present
Add site visit to Outlook calendar and reserve a car (if needed)
Review temp logs and Pre-visit Worksheet
Send a reminder email 2-3 days ahead of the visit
IPI Advisor Manual | February 2017 Page 11
i i li
Site Visits Chapter 3
Information for the Visit2017 MnVFC Pre-Visit Worksheet Site name MnVFC PIN
Address
Medical director Email
Immunization manager Phone
Vaccine coordinator Phone
Vaccine coordinator back-up Email
IPI Site Vis t Preparat on Check st
The staff listed have completed the MnVFC online training and printed a certification of completion Immunization Manager Vaccine coordinator Vaccine coordinator back-up
Have a copy of the most recent provider agreement
Check if the above listed staff have changed since the provider agreement was completed
Check all of the vaccines administered at your site and list the corresponding publication date for each VIS you give to patients
DTaP _____________ Hepatitis A _____________ Hepatitis B _____________ Hib _____________ HPV _____________
Influenza _____________ MCV4 _____________ MMR _____________ MMR-V _____________ PCV13 _____________
Polio _____________ Rotavirus _____________ Tdap _____________ Varicella _____________
Non-Routine Vaccines Men B__________ PPSV23 _____________ Td _____________
Vaccine administration fee charged for MnVFC eligible children is $
Have a Vaccine Management and Emergency Plan that has been reviewed and dated within the last year
Have the borrowing reports if applicable for the last 12 months available at the visit
Have an anaphylaxis protocol that is clearly posted and reviewed annually
Send an appointment reminder email and the MnVFC Pre-Visit Worksheet to the MnVFC contact A sample letter and the MnVFC Pre-Visit Worksheet can be found on the IPI Advisor Site Visit Materials (wwwhealthstate mnusdivsidepcimmunizeipisvmaterialshtml) page You can request that the MnVFC Pre-Visit Worksheet and temperature logs be sent to you prior to the visit for your review
Contact the site by phone or email one or two working days before the scheduled visit to confirm your appointment This is also a good time to ask for directions and parking information if you are not familiar with the site
Preparing for the Visit Review the site visit paperwork to familiarize yourself with the questions For most of the questions there is a ldquoNote to the reviewerrdquo These notes give helpful tips about the information you are looking for when asking this question It contains the rationale for the question and which resources to provide to the site to support the rationale Some sections also require immediate on-site actionsmdashthings you must do while you are at the site and some require future follow up
bull Print copies the of site visit paperwork bull Site visit forms are available on the IPI Advisor Site Visit Materials (wwwhealthstatemnusdivs idepcimmunizeipisvmaterialshtml) page 2017 MnVFC Site Visit Questionnaire 2017 MnVFC Site Visit Storage amp Handling per Unit Answer Sheet (print one for each stand-alone andor combination storage unit at the site) 2017 MnVFC Provider Follow-up Plan (print two copies)
bull Review any previous site visit paperwork that is available You should check in with MDH staff after your visits if the site continues to have the same issues as past visits
bull Also be sure to bring Your thermometers If the sitersquos certificate of calibration is expired or the probe is not properly placed place your thermometer in the storage unit when you arrive and read the temperature just prior to reviewing the site visit findings
The MnVFC folder with additional immunization resources you wish to add (see chapter 5) and the Vaccine Storage amp Handling magnet (to order email healthIPIinquiriesstatemnus) A copy of the appropriate MnVFC Policies and Procedures Manual found on the MnVFC website (wwwhealthstatemnusvfc) Appropriate temperature logs (Celsius or Fahrenheit) Site information sheet that contains the quantity and value of the vaccine distributed to the sitesystem
Page 12 IPI Advisor Manual | February 2017
Site Visits Chapter 3
Conducting the Visit Education is a large part of the MnVFC site visit Often approaching this visit as an exchange of information with the site is more successful than a ldquoregulatoryrdquo visit Putting the staff at ease answering their questions and making a plan to address issues that arise during the visit is more helpful than a ldquopassfailrdquo attitude Education will usually consist of providing the rationale for the requirement referring to the requirement in the MnVFC Policies and Procedures Manual and providing resources to help address the situation Some questions will require additional follow-up to assure the site has corrected the issue(s) and is meeting the MnVFC requirement(s) This will be addressed further in the follow-up section
Completing the Paperwork
There are three documents that you must complete for the MnVFC site visit bull 2017 MnVFC Site Visit Questionnaire bull 2017 MnVFC Site Visit Storage amp Handling per Unit Answer Sheet (one for each storage unit) bull 2017 MnVFC Provider Follow-up Plan (two copies or you may ask them to make you a copy of the completed form for their records)
Answer the questions on the MnVFC Site Visit Questionnaire based on how things are when you arrive at the site If they correct the issue during the visit you will still mark it as an unmet requirement and document how it was addressed during the visit
The ldquoAnswerrdquo field will contain all the possible answer choices for this question For most questions answer choices will be followed by the markings below
bull Answer choices with no marking mean the site meets the CDC requirement bull Answer choices marked with an [X] indicate that this specific answer choice is non-compliant with a CDC requirement
bull Answer choices marked with an [O] indicate that this specific answer choice is not aligned with a CDC recommendation
If you marked the box with the [X] which is non-compliant with the CDC requirement conduct a root cause analysis to determine the reason for non-compliance Root cause analysis is an important component to a successful site visit It is used to identify the cause of the problem and help to resolve the issue There are several possible root causes that can be identified Choose only one root cause
bull Human cause Personal beliefsopinions Does not understand rationale of requirement Lack of concern for compliance
bull Organizational cause Competing job assignmentsworkload Lack of (insufficient) staff to perform required duties Budget limitations (for required equipment) Lack of (insufficient) training of staff Lack of (insufficient) processesprotocols
IPI Advisor Manual | February 2017 Page 13
Site Visits Chapter 3
Once identified the root cause should be documented in the questionnaire including a brief explanation of why you chose that cause This allows for follow-up with the site and a way to help find improvements to meet the unmet requirement Complete any immediate on-site action These often require providing education and resources for the site Mark the box for each action taken If you provide additional resources or information you can use the notes section to indicate the additional items
ldquoFuture follow-uprdquo are actions the site needs to take to meet the requirements of the program Wersquoll go over more specific information about the site visit questionnaire in Chapter 4
Performing the Site Visit
As you become familiar with the MnVFC program and develop a relationship with your sites you will develop a visit pattern that works for you Here is one possible sequence for conducting MnVFC site visits
bull When you arrive at the site if you have a business card it is helpful to provide it to the front desk staff person
bull When you meet with the immunization manager andor vaccine coordinator introduce yourself and explain the expectations for the visit
bull Ask to see the temperature monitoring device(s) It must have a current certificate of calibration and the probe must be properly placed in the unit If it does not meet the requirements place your thermometer in the unit at the beginning of the visit so that it has sufficient time to reach an accurate temperature by the time you complete your assessment of the storage units
bull 2017 MnVFC Site Visit Questionnaire Ask all of the questions You may have to modify the order of the questions based on what is best for the site When you get to the storage and handling section (section 4) use the answer sheet(s) to document the answers to the questions for each storage unit that stores vaccine (MnVFC or private) Do not write answers in the questionnaire unless there is an unmet requirement Be sure to ask if there is vaccine stored anywhere else at any time at this location This includes a co-located pharmacy If so these additional units will need to be assessed as well If the site has a combination refrigeratorfreezer household unit and is using both sections discuss with them the recommendation (and probable future requirement) to have a separate freezer Refer to MDH if they have further questions or need more information Be prepared to address any storage and handling mishaps that you may find A copy of the
Clinicianrsquos Vaccine Mishap Checklist is with your visit materials and the Emergency Response Worksheet is in the MnVFC Policy and Procedure Manual If you are unsure how to handle the problem call the MnVFC program at 651-201-5522 during or after the visit
Page 14 IPI Advisor Manual | February 2017
Site Visits Chapter 3
Ending the Visit bull Fill out the two copies of the 2017 MnVFC Provider Follow-up Plan (or ask them to make a copy once it is completed for their records) Indicate if they have not met the requirement by checking the box in the ldquoUnmetrdquo column If they are not meeting requirements check the required actions Review the plan with them reinforcing the positive things they are doing as well as reviewing the required follow-up action(s) Give the site a copy of the Provider Follow-up Plan Keep the signed copy of the Provider Follow-up Plan to submit with your paperwork Do not leave a copy of the Site Visit Questionnaire at the site
bull Let them know you will be sending a thank you email that will summarize the site visit Included in the email will be a survey link you would appreciate them completing regarding the visit
After the Visit bull Send the site a thank you email There is a template thank you letter on the IPI Advisor Site Visit Materials (wwwhealthstate mnusdivsidepcimmunizeipisvmaterialshtml) page Be sure you include the issues that you identified and the timeline for their completion as well as the good things you found at the visit In the template letter be sure to include the survey link The survey is very brief ndash a few questions and space to write comments
bull Either transfer your MnVFC Site Visit Questionnaire and MnVFC Site Visit Storage amp Handling per Unit Answer Sheet information to the fillable version or submit the handwritten form to MDH
Documentation of the Visit
Paperwork must be submitted to MDH within 10 days of the visit in order to meet the federal VFC programrsquos reporting requirements Do not wait to complete your follow-up before submitting the site visit paperwork
Send the following documents to MDH bull 2017 MnVFC Site Visit Questionnaire (includes the cover sheet) bull 2017 MnVFC Site Visit Storage amp Handling per Unit Answer Sheet (one for each unit) bull 2017 MnVFC Provider Follow-up Plan (original signed plan)
Submit site visit materials to bull Email healthIPIinquiriesstatemnus (preferred) bull Mail IPI Program Specialist
Immunization Practices Improvement Program Minnesota Department of HealthPO Box 64975St Paul MN 55164-0975
IPI Advisor Manual | February 2017 Page 15
Site Visits Chapter 3
Future follow-up Follow-up is an important component of the site visit It helps us ensure that the unmet requirements have been corrected The questionnaire has different time periods for follow-up depending on the question Do not wait to complete your follow-up before submitting the site visit paperwork
When you complete the Follow-Up Form make sure to keep a copy for yourself MDH also keeps track of follow-up required and will remind you if follow-up has not been completed by the deadline Most follow-up can be done with a phone call or email In-person follow-up is rarely required and should be discussed with MDH before scheduling a follow-up visit
All requirements that need follow-up are identified with a [X] on the site visit paperwork and are listed on the MnVFC Provider Follow-up Plan
bull Follow-up with the site to see how they have resolved the unmet requirements bull Document your follow-up on the Follow-Up Form available on the IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml) page If follow-up was done via letter or email a copy can be attached to the Follow-Up Form
bull Send your Follow-Up Form to MDH (healthIPIinquiriesstatemnus) with supporting documents and emails
bull If a site is not responding to your requests regarding follow-up contact your MnVFC clinical coordinatorplanner They can help with additional follow-up as needed
Page 16 IPI Advisor Manual | February 2017
Chapter 4 The 2017 MnVFC Site Visit Paperwork This chapter will go through the required MnVFC site visit paperwork with notes about information or resources to help the site address questions or issues that may arise during the visit
The MnVFC site visit paperwork is available on the IPI Advisor Site Visit Materials (wwwhealthstate mnusdivsidepcimmunizeipisvmaterialshtml) page
Please download the paperwork shortly before your visit as there may be updates and changes and this will be the most up-to-date version of the questionnaire We will send out a Workspace message with major changes
Required Paperwork for Site Visits bull 2017 MnVFC Site Visit Questionnaire bull 2017 MnVFC Storage amp Handling Per Unit Answer Sheet ndash one for each unit assessed during site
visit bull 2017 MnVFC Provider Follow-up Plan ndash with provider signature
Make sure to include the sitersquos PIN on all your paperwork Please complete and submit your site visit paperwork as soon as possible after your visit It may be helpful to schedule some time into your calendar to complete your paperwork in the days following your visit Once you have completed the post-visit follow-up send in the Follow-Up Form with documentation of the follow-up actions Please do not wait until you have completed your follow-up before sending in your initial paperwork
MnVFC Site Visit Questionnaire The questionnaire includes these six sections 1 Provider details 2 Eligibility 3 Documentation 4 Storage amp handling per unit 5 Storage amp handling site-wide 6 Inventory
IPI Advisor Manual | February 2017 Page 17
Page 18 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
The Site Visit Reviewer Legend The legend explains the formatting of the 2017 questionnaire This includes information that will be helpful in completing the site visit
Site Visit Reviewer Guide Legend
Section Number Content Area
Question number This area will always contain the text of the question
Note to reviewer The note to reviewer contains information that is necessary for properly asking and assessing responses tothe question above This may include definitions of terms requirement details and other helpful tips
Answers This field will contain all the possible answer choices for this question For most questions answer choiceswill be followed by the markings below
Answer choices marked with an [X] indicate that this specific answer choice is non-compliant with a CDC requirement Answer choices marked with an [O] indicate that this specific answer choice is not aligned with a CDC
recommendation
Review CDC RequirementRecommendation
This field will be populated with the CDC requirementrecommendation associated with the given question
Actions if Non-Compliant
Root Cause Analysis As part of the site visit reviewers are required to assess and understand the reasons why a provider office isnon-compliant with VFC program requirements ndash this is a root cause analysis Reviewers must choose theone root cause that they believe most contributes to the non-compliance Upon establishing the root causethe reviewer must provide a clear explanation of hisher findings
Immediate Action These are actions that CDC requires reviewers to take on site during the visit
Future Follow-up These are future follow-up actions (with designated due dates) that are required of the reviewer andorprovider to remedy non-compliance Reviewers must complete all follow-up in accordance with CDCestablished deadlines
Notes Information you want the VFC program to be aware of or that explains your answer in detail
bull Note to reviewer These are notes to help you understand what the question is asking for and to clarify things you might want to know when asking or rephrasing the question
bull Answers This section helps you to know when the answer does not meet the CDC requirement [X] or recommendation [O] Whenever an answer with a [X] is checked the ldquoActions if Non-compliant section must be completed The recommendations are usually good teaching points about best practices andor future requirements of the VFC program
bull Review the CDC RequirementRecommendation This section provides a specific outline of the requirement or recommendation to give you information to use in talking with the site staff
bull Actions if Non-Compliant This section describes what to do if the site is not meeting a requirement Root cause analysis This section asks you to probe beyond the surface to find what is driving the non-compliance It is intended to help uncover reasons for recurring non-compliance issues identify additional training needs and inform reviewer follow-up actions Select only one root cause and explain the particular circumstances in the space ldquoExplanation of root causerdquo line provided If there appear to be multiple issues choose the one that most contributes to the non-compliance and describe all factors in the explanation Immediate actions A list of actions to take during the site visit to address the issue Future follow-up A list of actions to take after the site visit by the set deadline
bull Notes This section can be used for notes to yourself or to MDH
IPI Advisor Manual | February 2017 Page 19
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 1 Provider Details Questionnaire Coversheet
The first page of the questionnaire collects the demographic information for the site You can use this page to help prepare for the visit Most of the demographic information about the site should be on the site-specific document you received with your clinic list You will validate that this information is current at the time of the site visit It also helps to know if this is a separate stock site or a replacement site before the visit so you can bring a copy of the appropriate MnVFC Policies and Procedure Manual
2017 MnVFC Site Visit Questionnaire Date of visit _____________ Date forms sent to MDH ______________
Site Information
Site name MnVFC PIN
Address Separate Stock Replacement
City ZIP County
Medical Director Email
Immunization Manager Phone
Vaccine Coordinator Phone
Vaccine Coordinator back-up Email
Point of contact Phone
Personnel at site visit
On this page bull The date of the visit and the date when you send these forms to MDH This information helps us track the timeliness of our review and data entry process
bull The vaccine management method used by the site (replacement or separate stock) bull The name and email of the medical director (ideally this is the person who signed the MnVFC
Program Provider Agreement)bull Contact information for the immunization manager vaccine coordinator vaccine coordinator back-up and point-of-contact for this visit The immunization manager vaccine coordinator vaccine coordinator back-up roles are
described in the MnVFC Policies and Procedure Manual The vaccine coordinator back-up may be the immunization manager or another staff person depending on the size of the site and available personnel The Point of Contact is the person you set up the appointment with signs the Provider Follow-
up Plan and receives the follow-up email This may be one of the people listed above
The Post Visit Steps section is a reminder to you about what needs to done after the visit The Education on Immunization Best Practices for Sites section reminds you to provide the resource folder to the site
Page 20 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 12
1 Provider Details Changes to Key Staff
Question 12 Ask the provider about changes to key staff to answer the questions below
A (Choose all that
apply)
At the time of the visit is the Medical Director the same individual that signed the ProviderAgreement and are the Immunization Manager and Vaccine Coordinator the same asthose last reported to the program
Yes No the Medical Director has changed No the Immunization Manager has changed No the Vaccine Coordinator has changed
B (Choose one)
Were all changes communicated to theImmunization Program according to yourprogramrsquos policy
Yes or no staff changes No [X]
C (Choose one)
Based on review of the trainingdocumentation have the current Immunization Manager Vaccine Coordinator and back-up completed all required training
Yes No [X]
Review CDC Requirement
All changes in key staff must be communicated to the Immunization Program in the manner and timeframe defined by theImmunization Program Key staff include the Medical Director or equivalent who signed the Provider Agreement the Immunization Manager Vaccine Coordinator and the back-up VFC providers are required to ensure that all key staff are fully trained on VFC program requirements at all times All training must be documented
Goal of this question Determine if there are new staff in key positions at the site and to make sure staff are properly educated about the MnVFC program A This information can help you determine the level of knowledge and experience the staff have with the MnVFC program Follow-up throughout the visit can be tailored for various levels of staff experience Likewise you may identify additional training needs for new staff
B When sites notify us of changes in key personnel we update their information in MIIC and on the clinic lists We also send the new staff information for completing the online training and direct them to read the appropriate MnVFC Policies and Procedures Manual If the answer to this part is no update the demographic area of the questionnaire and inform the staff that in the future they must notify the MnVFC program (via email or phone) if the immunization manager or vaccine coordinator changes Resource Section 12 of the MnVFC Policies and Procedures Manual
C Annual training must be verified by looking at the certificates for the online training If the answer to this part is no refer the staff to complete the appropriate MnVFC online training found on the MnVFC website (wwwhealthstatemnusvfc) for their program (separate stockreplacement) for the current year and send you a copy of the certificate within 30 days
Resource bull Sections 12 and 14 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 21
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 2 Eligibility Question 21
Goal of this Question Assess whether staff correctly understand which patients are eligible for the MnVFC program Screening ensures that eligible children receive the vaccines that they are entitled to receive under the MnVFC program and helps to prevent fraud or abuse of the program
Children 18 years and younger in these
categories can receive MnVFC vaccine at any enrolled site bull Uninsured bull Enrolled in a Minnesota Health Care Program (MHCP) Medical Assistance (MA) or MinnesotaCare bull American Indian or Alaskan Native
The following categories are considered underinsured and are only MnVFC-eligible at local public health (LPH) Federally Qualified Health Centers (FQHC) Rural Health Centers (RHC) Indian Health Services (IHS) and tribal health clinics
bull Has health insurance that does not cover one or more vaccines as can be the case with newly licensed vaccines that arenrsquot yet covered (MnVFC-eligible for non-covered vaccines only)
bull Has health insurance that caps vaccine coverage at a certain amount Once that amount is reached the child is MnVFC-eligible
Children with insurance that does not cover vaccines until a deductible has been met are considered to be fully insured and are not MnVFC-eligible
Helpful information bull Sites are not required to verify the patientrsquos response to the screening questions For example if a patient states they lost their insurance the site does not need to call the patientrsquos insurance company to confirm
If the site cannot correctly describe the eligibility categories provide educational materialsresources on MnVFC eligibility requirements
Resources bull Patient Eligibility Screening Record on MnVFC Forms (wwwhealthstatemnusdivsidepc immunizemnvfcformshtml)
bull Section 1 of the MnVFC Policies and Procedures Manual
2 Eligibility VFC Eligibility Categories
Question 21 Was the individual responsible for determining patient VFC eligibility able to explain all the factors(including age) that make a child eligible to receive VFC vaccines
A Patient is less than 19 years of age Yes No [X]
B Patient is Medicaid-eligible Yes No [X]
C Patient is uninsured Yes No [X]
D Patient is underinsured Yes No [X]
E Patient is American Indian Yes No [X]
F Patient is Alaska Native Yes No [X]
Review CDC Requirement
VFC providers must possess a working knowledge of all VFC eligibility criteria and use those criteria to screen children prior toadministering VFC vaccines In order to receive VFC vaccine a patient must be under the age of 19 and must be at least one of the following (1) Medicaid-eligible (2) Uninsured (ie child has no health insurance) (3) Underinsured (ie child has health insurancebut coverage does not cover any or certain vaccines ndash underinsured children may only receive VFC vaccines in FQHCRHC ordeputized VFC provider offices and only for vaccines not covered by insurance) and (4) American Indian or Alaska Native (AIAN)
Page 22 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 22
2 Eligibility Billing Practices
Question 22 Is the individualdepartment responsible for billing able to clearly explain how they bill for both the costof vaccine and the vaccine administration fee for each of the eligibility categories below
A Medicaid-eligible Cost of Vaccine Do not bill ndash provided by VFC Admin Fee Bill Medicaid
Yes No [X]
B Uninsured Cost of Vaccine Do not bill ndash provided by VFC Admin Fee If billing can bill patient
Yes No [X]
C Underinsured Cost of Vaccine Do not bill ndash provided by VFC through FQHCsRHCs or deputized providers only all other providers cannotprovide VFC vaccine to underinsured patients Admin Fee If billing can bill patient
Yes No [X]
D American IndianAlaska Native(AIAN)
Cost of Vaccine Do not bill - provided by VFC unless patient is fully insured and parent chooses to use insurance Admin Fee If patient is Medicaid-eligible bill Medicaid if billingand patient is uninsuredunderinsured can bill patient if parentchooses to use private insurance for cost of vaccine billpatientinsurance
Yes No [X]
E Do individuals responsible for billing have access to the results of eligibility screening toensure proper billing
Yes No [X]
Review CDC Requirement
VFC providers must adhere to proper billing practices for vaccine administration fees and clearly understand that VFC vaccine isprovided at no cost to both the VFC provider and eligible children At no time should billing occur for the cost of VFC vaccine Whenadministering VFC vaccine providers should never bill two different ldquopayersrdquo (ie patient Medicaid insurance) for the samevaccine administration fee amount For Medicaid-eligible children Medicaid should be billed for the vaccine administration fee Forall other VFC-eligible populations the patient may be billed within the stateterritory cap established by the Centers for Medicareand Medicaid (CMS) However patients cannot be turned away or reported to collections for inability to pay the administration fee
Goal of this question Determine if the staff correctly understand how to bill patients that are eligible for the MnVFC program Billing appropriately ensures that children can receive low cost immunizations and the site is in compliance with the VFC program
bull If there is any indication that sites could be billing insurance companies or parents for VFC vaccines this should be investigated further
bull Most sites in Minnesota will bill Medicaid with the SL modifier ndash which indicates this is a Medicaid claim
bull The main point is to ensure the site is not billing uninsured children for VFC vaccine and are not charging them more than $2122 per vaccine for the administration fee
bull Non-compliance is usually unintentional and may be resolved with some training In rare cases it could be a glimpse into a larger problem where a site is intentionally billing for financial gain
bull If you think the site is billing inappropriately it is the responsibility of the IPI advisor to report concerns to MDH staff for further assistance
Resources bull Immunization Billing Guidance for MnVFC (wwwhealthstatemnusdivsidepcimmunizemnvfc billingtipshtml) or Immunization Billing Guidance for MnVFC Replacement Method Sites (www healthstatemnusdivsidepcimmunizemnvfcreplacementbillingtipsrephtml)
bull Section 2 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 23
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 232 Eligibility Vaccine Administration Fee
Question 23 Document the actual vaccine administration fee charged to non-Medicaid VFC-eligible patients (confirmwith billing department)
Answers Fee $ [X] Follow-up is required if the provider charges more than the fee cap establishedby the Centers for Medicare and Medicaid (CMS) for your stateterritory ($2122)
Review CDC Requirement
The VFC providerrsquos vaccine administration fee for non-Medicaid VFC-eligible children must not exceed the stateterritory vaccineadministration fee cap established by the Centers for Medicare and Medicaid (CMS) For current fee caps refer to Medicaid Program Payments for Services Furnished by Certain Primary Care Physicians and Charges for Vaccine Administration Under theVaccines for Children Program Final Rule (httpwwwgpogovfdsyspkgFR-2012-11-06pdf2012-26507pdf)
Goal of this question Ensure that sites are not charging more than the federal allowable vaccine administration fee of $2122
bull The Centers for Medicaid and Medicare (CMS) establishes a maximum fee that sites can charge to non-Medicaid-eligible VFC patients in each stateterritory for vaccine administration Health Plans usually negotiate this fee with the site but Medicaid will not pay more
bull If a parent cannot pay the vaccine administration fee the patient cannot be turned away or reported to collections VFC-eligible children must be vaccinated regardless of their ability to pay
bull If the person with whom you are conducting the site visit does not know the exact fee charged to non-Medicaid VFC-eligible patients ask to speak to someone who can verify the exact amount
bull If they are charging more than $2122 for the administration fee ndash please contact MDH staff for help with addressing this situation
Resources bull Immunization Billing Guidance for MnVFC (wwwhealthstatemnusdivsidepcimmunizemnvfc billingtipshtml) or Immunization Billing Guidance for MnVFC Replacement Method Sites (www healthstatemnusdivsidepcimmunizemnvfcreplacementbillingtipsrephtml)
bull Section 2 of the MnVFC Policies and Procedures Manual
Page 24 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 3 Documentation Question 31
3 Documentation Eligibility Screening amp Documentation
Question 31 To answer the questions below the provider must clearly demonstrate the patient intake processReview a minimum of 10 records that contain an immunization visit within the last 6 ndash 12 months
Note to Reviewer Criteria for Record Selection 1) Record selection must be completely random and the provider must not know prior to the visit which
records will be reviewed 2) Patient must have been 0-19 years of age at the last visit (Note Records of 19-year-old patients may
allow you to see if VFC vaccines are being used beyond the allowable age) 3) Must review a mix of public and private-pay patients (if applicable)
A Does the provider have a process that ensures that patients are screened forVFC eligibility at each visit and that screening results are documented at each visit
Yes No [X] (If no skip question F)
B Does the providerrsquos process ensure that staff administering vaccine know which vaccine stock to select from prior to drawing the vaccine
Yes No [X]
C Number of records reviewed If fewer than 10 records are reviewed select the reason why Provider does not have 10 patient records with immunizations in last 12 months
D Do all records contain date of the immunization visit and patientrsquos date of birth Yes No [X]
E Do all records contain the patientrsquos specific eligibility status associated with thedate of the immunization
Yes No [X]
F Do any of the providerrsquos records contain any evidence that the patient received vaccine for which they were not eligible
Yes [X] No
Review CDC Requirement
VFC providers must screen for and document VFC eligibility at each immunization visit Documentation must include the date of the visit and the childrsquos specific eligibility category VFC providers must use screening results to ensure that only VFC-eligible children receive VFC vaccine and that administration fees are billed for as appropriate Eligibility status must be readily available to staff administering vaccine prior to selecting which vaccine stock to use
Goal of this question Ensure the site is screening for eligibility and documenting the eligibility category in the medical record
Review a minimum of 10 records from within the last 6-12 months where the patient received an immunization You must review a mix of public and private pay patients (if applicable)
Random selection is important If the staff have pre-selected records for review do not use and identify additional randomly selected records to review
Helpful information bull Discuss upgrading the electronic health record to make documentation of VFC eligibility screening a required field Documenting eligibility screening in the immunization field promotes better MIIC data
bull Q 31 B Sites using the replacement method of vaccine management only have one stock so you will answer ldquoYesrdquo to this question
Resources bull Patient Eligibility Screening Record on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfcformshtml)
bull Section 1 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 25
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 32
3 Documentation Vaccine Dose Documentation
Question 32 Review a minimum of 10 patient immunization records from the last six months (or 12 months ifnecessary) to assess compliance with documentation requirements set forth by Statute 42 US Code 300aa-25 (See note to reviewer below)
Note to Reviewer Criteria for Record Selection 1) Record selection must be completely random the Provider must not know prior to the visit which records
will be reviewed 2) Patient must have been 0-19 years of age at the last visit (Note Records of 19-year-old patients may allow
you to see if VFC vaccines are being used beyond the allowable age)
Records are Compliant if they Contain ALL the Below Elements
bull Address of clinic where vaccine was administered bull Publication date of VIS bull Name of vaccine administered bull Name of vaccine manufacturer bull Date vaccine was administered bull Lot number bull Date VIS was given bull Name and title of person who administered the
vaccine
A Number of records reviewed
B Number of records that contain ALL required documentation elements
If fewer than 10 records are reviewed select the reason why Provider does not have 10 patient records with immunizations in last 12 months
[X] Follow-up isrequired if one ormore records do not meet requirements
Goal of this question Assess whether the site is documenting all required information in each patientrsquos medical record for every vaccine dose administered in accordance with the National Childhood Vaccine Injury Act
Resources bull Section 6 of the MnVFC Policies and Procedures Manual bull National Vaccine Injury Compensation Program (wwwhrsagovvaccinecompensation)
Question 33
3 Documentation Record Retention
Question 33 Is the provider able to demonstrate (preferred) or clearly describe how they maintain historical VFCeligibility documentation for three years
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers are required to maintain all records related to the VFC program for a minimum of three years (or longer if requiredby state law) and upon request make these records available for review VFC records include but are not limited to VFC screening and eligibility documentation billing records medical records that verify receipt of vaccine vaccine ordering records and vaccinepurchase and accountability records
Goal of this question Make sure the site understands they are required to keep all MnVFC screening documentation for at least three years either electronically or on paper This information should be available to you at the time of the visit and future visits
Resource bull Section 7 of the MnVFC Policies and Procedures Manual
Page 26 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 34
3 Documentation Borrowing Documentation
Question 34 Discuss borrowing practices with the provider to answer the questions below
Note to Reviewer bull To be considered ldquofully documentedrdquo documentation for each borrowed dose must include thefollowing information
Vaccine type borrowed Date the dose was administered Stock used (VFC or private) Reason appropriate vaccine stock was not used Patient name and date of birth Date dose was returned to appropriate stock
A Did the provider state that they had borrowed any vaccines (whetherdocumented or not) since the last VFC Compliance Site Visit
Yes No (If no skip to question 36)
B Are there any doses for which there is no documentation (ie provider hasindicated that doses were borrowed but cannot verify how many or why)
All doses are documented Some doses are not documented [X] No doses are documented [X] (if nodoses documented skip toquestion 36)
C Were all borrowed doses fully documented (See Note to Reviewer above) Yes No [X]
D Were all borrowed VFC doses either replaced or an order submitted to replacethe doses Yes No [X]
Review CDC Requirement
VFC providers are expected to maintain an adequate inventory of vaccine for VFC and non-VFC-eligible patients It is theresponsibility of the VFC provider to appropriately schedule and place vaccine orders VFC providers must also rotate stock to ensure timely use of short-dated vaccines Borrowing of vaccine between private and public inventories must be a rare unplanned occurrence and cannot serve as a replacement system for a VFC providerrsquos privately purchased vaccine inventory All instances ofborrowing must be properly documented reported and replaced
Goal of this question Assess vaccine accountability by verifying that children are receiving vaccine from the appropriate stock
Borrowing is when a fully insured child receives a dose of MnVFC vaccine or a MnVFC-eligible child receives a dose of private vaccine This should be a rare unplanned occurrence The site must document any borrowing of vaccine between stocks ideally on the VFC Borrowing Report Form If they are not currently using the form review it with them and encourage them to post it close to their vaccines It does not need to be sent to MDH but should be kept for 3 years and filed with their MnVFC documents to be reviewed whenever they have a regular or unscheduled (unannounced) site visit
Helpful information bull Understand and report on staffrsquos verbal (ie anecdotal) accounts of borrowing obtained during the visit Often sites do not know that what they do is considered borrowing or they think borrowing is acceptable and documentation isnrsquot needed so long as those vaccines are eventually replaced
bull Since sites using the replacement method only have one stock of vaccine they very rarely borrow bull This question asks for future follow-up in 6 months Make a note on your calendar and ask them to send you a copy of their borrowing reports for the previous 6 months with documentation of doses borrowed and replaced We will remind you if we donrsquot hear from you at the 6 month time frame Complete the Follow-up Form and attach the borrowing form
Resources bull Vaccine Borrowing Report on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfc formshtml)
bull Section 10 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 27
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 353 Documentation Borrowing Reasons
Question 35 Based on your discussion with the provider and a review of borrowing reports document the dosesborrowed for each reason and answer the questions below
Note to Reviewer bull Short-dated vaccines are doses that are likely to expire before they can be used bull Exchanging short-dated vaccines should only occur in practices that have a small number of private
patients
A Reasons for Borrowing a VFC Dose (Enter the number of _____ Private vaccine shipment delay (order placed on time but delay in shippingreceipt)
vaccine doses borrowed for each
reason in the spaces
_____ Private vaccine not useable on arrival (vials broken temperature monitor out of range) _____ Ran out of private vaccine between orders (provider orders not placed on time) [X]
provided) _____ Short-dated private dose was exchanged with VFC stock _____ Accidental use of VFC dose for a private patient (human error) _____ Replacement of private dose with VFC when insurance plan did not cover vaccine _____ OtherDocumented dose did not include reason for borrowing [X]
(Explanation Required) Reasons for Borrowing a Private Dose _____ VFC vaccine shipment delay (order placed on time but delay in shippingreceipt) _____ VFC vaccine not useable on arrival (vials broken temperature monitor out of range) _____ Ran out of VFC stock between orders (provider orders not placed on time) [X] _____ Short-dated VFC vaccine dose was exchanged with private dose _____ Accidental use of a private dose for a VFC-eligible patient (human error) _____ OtherDocumented dose did not include reason for borrowing [X]
(Explanation Required)
B Enter date range for instances of borrowing reviewed in the borrowing report Note If ldquoDate of earliest instancerdquo is not available use the date of the last VFC Compliance Visit If ldquoDate of last instancerdquo is not available use the date of thecurrent VFC Compliance Visit
Date of earliest instance
Date of last instance
C Does borrowing appear to be a routine practice Note To determine whether borrowing is a routine practice assess frequency of and repeating reasons for borrowing Examples Frequent accidental use of incorrect stock exchanging short-dated vaccines or issues with ordering and shipment
Yes [X] No
Goal of this question Determine the reasons why the site is borrowing vaccine
If sites are using the Vaccine Borrowing Report review the reasons for borrowing to help document borrowed VFC andor private doses If they have not been documenting borrowing on this report (or any other form) estimate their borrowing practices If you do not know the date range for their borrowing use the last site visit date to the current visit date The use of ldquootherrdquo as the reported reason for borrowing should be rare if ever and would require explanation and follow up
Helpful information bull Look to see if they routinely maintain insufficient amounts or types of vaccine to support their public and private patients that leads to borrowing
bull Pay attention to borrowing cases documented as ldquoaccidentalrdquo Repetitive accidental borrowing may indicate an issue with ordering processes or insufficient staff training
bull Borrowing is not a place to document wasted or lost doses bull The time period of the borrowing may give you clues about the root cause Were the borrowed doses concentrated in a short period or spread out across several months or a year Are all vaccine types being borrowed or just one
bull If borrowing seems to be an issue discuss vaccine management ordering procedures
Resources bull Vaccine Borrowing Report on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfc formshtml)
bull Section 10 in the MnVFC Policies and Procedures Manual
Page 28 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 36
3 Documentation Vaccine Management Plan
Question 36 Physically review the providerrsquos Vaccine Management Plan to answer the question below
A Does the provider have a Vaccine Management Plan Yes No [X] (If no skip to question 37)
B Does the plan list the current Immunization Manager Vaccine Coordinator andback-up
Yes No [X]
C Does the plan address proper vaccine storage and handling practices Yes No [X]
D Does the plan specify vaccine receiving procedures Yes No [X]
E Does the plan contain procedures for what to do with vaccine in the event of an emergency
Yes No [X]
F Does the plan contain procedures for vaccine ordering Yes No [X]
G Does the plan address inventory control (example stock rotation) Yes No [X]
H Does the plan address how to handle vaccine wastage Yes No [X]
I Does the plan address staff training and documentation on vaccine managementstorage amp handling
Yes No [X]
J Does the plan contain a review date that falls within the last 12 months Yes No [X]
K Has the plan been signed by the individual responsible for its content Yes No [X]
Review CDC Requirement
VFC providers must develop maintain and implement a Vaccine Management Plan for routine and emergency vaccinemanagement The plan must contain the current Vaccine Coordinator and back-up proper storage and handling practicesshipping and receiving procedures emergency procedures procedures for vaccine ordering inventory control (eg stock rotation)how to handle vaccine wastage and staff trainingdocumentation on vaccine management storage and handling The plan must bereviewedupdated annually or more frequently if changes occur A ldquoreview daterdquo and signature are required on all plans in order tovalidate that they are current
Goal of this question Evaluate the sitersquos plan for vaccine management It is especially important that they have a plan for emergency management of their vaccine in the case of equipment failure or power outage Encourage all sites to read and sign the MnVFC Policies and Procedures Manual and complete the emergency plan or be able to show you a plan of their own
If the provider is not able to physically show you the plan at the time of the visit or if the recorded review date is not within the last 12 months you must mark that this requirement is unmet The Vaccine Management Plan is important in times of emergency and it should be easy to access by any staff member at any time Encourage them to post the plan and put a copy with the packing supplies
Helpful information bull Encourage the site to fill in the ldquoImmunization Managerrdquo and ldquoVaccine Coordinatorrdquo fields in the
MnVFC Policies and Procedures Manual for their own referencebull The emergency plan in the manual can be reviewed from last year and included in this yearrsquos manual (with an updated signature and date) if there have not been any changes
bull If information in the plan is outdated site staff will not be well equipped to safely manage vaccines in the event of a power-outage or other emergency situation
bull If their institutional policy is only reviewed and updated every 3-4 years (as many are) the staff may need to sign the MnVFC Polices and Procedure Manual to meet this requirement
Resource Routine Vaccine Management Plan and Emergency Vaccine Management Plan in the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 29
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 37
3 Documentation VIS amp VAERS
Question 37 Review the providerrsquos Vaccine Information Statements (VISs) and discuss providerrsquos VAERS process toanswer the questions below
A Does the provider have readily available up-to-date VISs for all ACIP-recommendedvaccines relevant to the populations it serves
Yes No [X]
B Does the provider make a VIS available for patientsparents before eachvaccination
Yes No [X]
C Does the provider know how and when to report clinically significant adverseevents using VAERS
Yes No [X]
Review CDC Requirement
VFC providers are required to distribute the current Vaccine Information Statements (VIS) each time a vaccine is administered and maintain records in accordance with the National Childhood Vaccine Injury Act (NCVIA) which includes reporting clinicallysignificant adverse events to the Vaccine Adverse Event Reporting System (VAERS) For a list of current VISs visit CDCrsquos Vaccine Information Statements (httpwwwcdcgovvaccineshcpvis) website
Gal of this question Ensure the site has the most current VISs and is giving them to each patientparent before administering the vaccine in compliance with the federal law Parents must be educated about the vaccine their child will receive and be aware of possible contraindications and side-effects in order to make well-informed decisions about their childrsquos health
Helpful information bull Ask to see the sitersquos VISs to determine if they have an active protocol for giving VISs to parents Review to make sure they are current Ask if they know where and how to report vaccine adverse events
Resources bull Section 3 in the MnVFC Policies and Procedures Manual bull CDC Vaccine Information Statements (wwwcdcgovvaccineshcpvisindexhtml) Site may sign up for email updates for the current list of VIS publication dates for the most up-to-date version
bull IAC Itrsquos Federal Law You must give your patients current Vaccine Information Statements (wwwimmunizeorgcatgdp2027pdf)
bull VAERS (httpsvaershhsgovindex)
Question 38
3 Documentation Anaphylaxis protocol
Question 38 Does the site have an anaphylaxis protocol which is clearly posted near the emergency kit
Answers (Choose one)
Yes No [X]
Review CDC Requirement
An anaphylaxis protocol must be clearly posted in the area where vaccines are administered
Goal of this question Make sure site is prepared for a severe allergic or anaphylactic reaction to a vaccine
Resources bull Section 11 in the MnVFC Policies and Procedures Manual bull IAC protocols Child and Teens (wwwimmunizeorgcatgdp3082apdf) and Adults (wwwimmunize orgcatgdp3082pdf)
Page 30 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
i
i i i - li i i i i i l
Section 4 Storage amp Handling Per Unit The goal of this section is to assess vaccine storage
2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet practices in each unit at the site MnVFC PIN ___________________
The 2017 MnVFC Storage amp Handling Per Unit Answer Sheet is a worksheet to document the answers to the questions in this section for each unit (combination or stand-alone) Fill in the answers to the questions in Section 4 on the answer sheet not in the questionnaire
The answer sheet has an abbreviated form of each question If you need further information on that question refer back to the full questionnaire Also if you find an area where the site is not meeting the requirements you will need to go back to that question on the 2017 MnVFC Site Visit Questionnaire to complete ldquoActions if Non- compliantrdquo section including the root cause analysis and follow-up sections If there is a problem in more than one unit make a note on the questionnaire which unit you are referring to in the Notes section
Important You must fully assess any unit that may be used to store VFC vaccines even if there are no VFC vaccines there on the day of the visit If there are no vaccines and the site is not documenting twice a day temperatures discuss the need to ensure the unit is maintaining stable temperatures by monitoring for one week before placing vaccines in the unit
Quest on number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
for the freezer and e co umn
Temperature Monitoring Dev refr gerator f the un
ce Quest ons Quest ons 4 3 4 7 must be answered separate y t s a combo Be sure to document responses n the appropr at
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
44D Data downloaded and reviewed routinely (eg weekly)
Yes No [O]
Yes No [O]
45A Certificate of Calibration Testing Yes No [X]
Yes No [X]
45B Date of calibration
45C Date certificate expires [X] Follow-up is required if expired [X] Follow-up is required if expired
45D Certificate contains all necessary items
Yes No [X]
Yes No [X]
46 Probe properly placed Yes No [X]
Yes No [X]
47A Two temperature readings per day
Yes No [X]
Yes No [X]
47B Time date and name (or initials) for each reading
Yes No [X]
Yes No [X]
47C Current temperature and minmax temperatures (if
Current ________deg Minimum ________deg Maximum _deg
Current ________deg Minimum ________deg Maximum _deg
Sections 5 and 6 contain questions about storage and handling site wide and inventory It is helpful to keep those questions in mind as you assess the individual storage units Think about dorm-style units expired vaccine vaccine supply room for vaccine stocking all the recommended vaccines and separation of stock if appropriate
NOTE The sections that follow require reviewers to validate responses by looking at vaccine storage units temperaturemonitoring equipment and the vaccine inventory inside a unit bull For section 4 use a separate Storage amp Handling Per Unit Answer Sheet for each unit to document the findings (combination
units using both sections can be documented on the same answer sheet) bull When an unmet requirement is identified return to this questionnaire to complete the ldquoActions if Non-compliantrdquo section for
that question bull After you complete one answer sheet for each unit return to the questionnaire to complete sections 5 and 6 using information
you gathered while assessing the units The questions in sections 5 and 6 (Storage amp Handling Site-Wide and Inventory) are notunit-specific but do require that the response be based on a thorough assessment of all the providersrsquo units
4 Storage amp Handling Per Unit
Description On the Storage amp Handling Per Unit Answer Sheet place a name that will allow you or someone else from your program to easily identify this unit in the event of follow-up We recommend using Brand + Location(example Samsung - Room 123) Save each Storage amp Handling Per Unit Answer Sheet with the Brand + Location in the file name
(example SamsungRoom123doc)
IPI Advisor Manual | February 2017 Page 31
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 41
4 Storage amp Handling Per Unit Storage Unit Build amp Use
Question 41 Below select the build and use of the vaccine storage unit you are assessing
Note to Reviewer Dorm-style units Do not add dorm-style units here Dorm-style units will be addressed in section 5 Units storing only private stock You must review these storage units even if they contain only private stockat the time of the visit because that vaccine could be administered to VFC patients
A What type of unit is this A Stand-alone B Combination
B Select use if stand-alone A Freezer B Refrigerator
Select use if combination A Use both sections to store vaccine B Use freezer section only to store vaccine C Use refrigerator section only to store vaccine
Goal of this question Identify the unit you are evaluating The description asks you to create a unique name for this unit so that you will be able to identify the same unit in future site visits Put this description on the top of the answer sheet (ie make and location)
Helpful information bull A stand-alone unit is either a refrigerator or a freezer It does not have both sections in the unit bull If there is a combination unit note if the site uses both the refrigerator and freezer or only one section of the unit to store vaccines CDC does not recommend the use of either section or the freezer section only of combination household units
bull If your site utilizes the separate stock method of vaccine management you must review storage units even if they contain only private stock at the time of the visit because there is a chance that those vaccines could be administered (borrowed) to VFC-eligible patients
Page 32 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 424 Storage amp Handling Per Unit CDC Recommended Storage Units
Question 42 Below document the grade of the vaccine storage unit you are assessing
Note to Reviewer Pharmaceutical Also called ldquopurpose-builtrdquo these units are designed by the manufacturer specifically tostore vaccines or other biological materials Commercial Although usually intended to store food and beverages commercial units are often larger and more powerful than the household units found in most homes Though these units are intended to meet thehigher demands of larger facilities these units are not specifically built for the storage of biologicalmaterials Household (non-commercialdomestic) These units are usually smaller than commercial units and areintended for use in small offices and in homes ndash typically for food storage However just like commercialunits they are not designed specifically for the storage of biological materials Such units are usually available in common home supply stores
Answers (Choose one)
Select grade A Pharmaceutical B CommercialHousehold
[O] CDC does not recommend the use of both sections or the freezer section only of combination commercialhousehold units
Review CDC Recommendation
CDC recommends the following vaccine storage unit types (in order of preference) pharmaceutical grade stand-alone orcombination units (preferred) householdcommercial stand-alone units householdcommercial combination units using therefrigerator section only
Goal of this question Assess the grade and type of each storage unit bull Pharmaceutical grade units may be stand-alone or combination units that are often metal may have glass in the door for viewing inside often have an external digital temperature display and are manufactured by medical companies
bull Commercial or household units often look like your kitchen appliance have vegetablemeat drawers in the unit and are manufactured by household appliance companies
bull Occasionally you might find a medical grade unit which is usually a commercialhousehold unit with a lock and 3-prong plug These are still considered household units because of their ability to maintain proper temperatures and air flow Studies show that household stand-alone units are better able to maintain consistent temperatures than their combination counterparts Combination household units used to store vaccine in both sections of the unit is no longer recommended and may be prohibited in the future Combination household storage units that are having difficulty maintaining a cold enough freezer temperature and a warm enough refrigerator temperature should be replaced or a separate stand-alone freezer should be purchased
For frozen vaccines the most cost effective solution is for the site to purchase a small stand-alone freezer The site may need time to budget for a stand-alone storage unit
Resources bull Replacing Combination Household Units Tip Sheet on IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml)
IPI Advisor Manual | February 2017 Page 33
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 434 Storage amp Handling Per Unit Temperature Monitoring Device in the Unit
Question 43 Determine whether there is a temperature monitoring device in this section of the storage unit andanswer the questions
A Is there a temperature monitoring device in this section of thestorage unit
Yes No [X] (If no skip to question 47)
B Who is responsible for supplying the temperature monitoring device in this section of the storage unit Provider
Review CDC Requirement
Certificates of calibration testing provide confidence that the temperature monitoring device is measuring temperaturesaccurately All units storing VFC vaccines must have a calibrated temperature monitoring device with a current and valid certificateof calibration testing All certificates must contain modeldevice name or number serial number date of calibration testing (report or issue date) and Instrument Passed testingInstrument in Tolerance (Recommended uncertainty = +-05ordm C (+-1ordm F))
Goal of this question Assess whether there is a temperature monitoring device in the unit If the unit is not being monitored at all call MDH at 651-201-5522 for guidance
Helpful information bull This question does not ask whether the temperature monitoring device is working or the characteristics of the device These issues will be addressed later in the questionnaire
bull For part B the provider is always responsible for supplying the temperature monitoring device Even if their thermometer or data logger was originally from MDH it is their responsibility to ensure it is functional and calibrated
Resources bull Section 8 in the MnVFC Policies and Procedures Manual
Page 34 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 444 Storage amp Handling Per Unit CDC Recommended Temperature Monitoring Device
Question 44 Assess the temperature monitoring device in this section of the storage unit to answer the questionsbelow
A Is the temperature monitoring device a continuous monitoring and recordingdevice (eg data logger)
Yes No [O] (Skip D)
B Does the temperature monitoring device have a probe in buffered material Yes No [O]
C Does the temperature monitoring device have a digital display that can beeasily read from the outside of this unit
Yes No [O]
D Is data downloaded and reviewed routinely Yes No [O]
Review CDC Recommendation
As of Jan 1 2018 all VFC providers must use continuous temperature monitoring devices (eg data loggers) to monitor vaccinesthat will be administered to VFC-eligible children Routine review and accessibility of temperature data is critical for determining whether vaccine has been properly stored and for assessing usability of vaccine that was involved in a temperature excursion Tomeet VFC Program requirements the device must also be equipped with bull A temperature probe bull An active temperature display that can be easily read from the outside of the unit bull The capacity for continuous monitoring and recording capabilities where the data can be routinely downloaded
The following are additional recommended features for these devices bull Alarm for out-of-range temperatures bull Current minimum and maximum temperatures display bull Low battery indicator bull Accuracy of +- 1degF (05degC) bull Memory storage of at least 4000 readings bull User programmable logging interval (or reading rate) recommended at a maximum time interval of every 30 minutes bull Use of a probe that best reflects the temperature of the vaccine (such as a buffered probe)
Goal of this question Assess the temperature monitoring device in the storage unit Note that these are all recommendations not requirements at this time
This is a great teaching opportunity for sites who do not currently have a continuous temperature monitoring device Beginning Jan 1 2018 all units that store MnVFC vaccine will be required to have a continuous temperature monitoring device (ie a data logger or a continuous temperature monitoring system) Unlike a minmax thermometer a continuous temperature monitoring device provides detailed information on all temperatures recorded at pre-set intervals For excursions it can provide information on when a temperature went out-of-range for how long and what the temperatures were This is essential information that vaccine manufacturers need to know to assess the viability of the vaccine following an excursion
Helpful information bull Sites are required to monitor and record temperatures twice daily however temperature excursions can easily occur in the 12 hours or longer between readings Continuous temperature monitoring can help manufacturers determine vaccine viability
bull Continue to encourage sites to document and evaluate minimum and maximum temperatures the storage unit reached since the last reading and respond appropriately to out-of-range temperatures
IPI Advisor Manual | February 2017 Page 35
The 2017 MnVFC Site Visit Paperwork Chapter 4
bull It is recommended that sites download and review data weekly Discuss with sites that reviewing temperature monitoring device data also includes responding appropriately if they identify out-of-range temps
bull There is sometimes confusion about the difference between a data logger and a continuous temperature monitoring system Here are some differences
Data Loggers Continuous Monitoring Systems Have an external display similar to thermometers May or may not have an external display Have a detachable probe Probe is usually attached to transmitter Need to be plugged into the computer or cradle to download information on a regular schedule
Wirelessly sends data to computer system
Create a file of data that needs to be saved on the computer
Data is stored within the system not a separate file
Doesnrsquot allow documentation of twice a day temperature checks in the file
May allow documentation of twice a day temperature checks within the system
More about the 2018 requirement for a continuous temperature monitoring device
Required Features bull The continuous temperature monitoring device must have Continuous monitoring and recording capabilities to track and record temperatures over time The capacity to routinely download temperature data to a computer (recommended at least weekly) or wirelessly transmit data Detachable probe in a bottle filled with a thermal buffer (eg bio-safe glycol) if the data logger needs to be detached in order to download data Active temperature display
Recommended Features bull MnVFC recommends continuous temperature monitoring devices with Alarm for out-of-range temperatures Accuracy within +-1degF (+- 05degC) Low battery indicator Display of current minimum and maximum temperatures Memory storage of at least 4000 readings User programmable logging intervals (eg the user can set how often the device records the temperature)
Note that these are all currently recommendations not requirements yet
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Page 36 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 45
Goal of this question Ensure the temperature monitoring device is properly calibrated The certificate of calibration testing means that the device has been tested and it is accurately measuring temperatures within established testing limits The certificate of calibration ensures that the device meets all the required components
Helpful information bull The provider is always responsible for having a current certificate of calibration (or copy) on-site
bull To be considered ldquovalidrdquo a certificate of calibration must contain these required elements Modeldevice name or number Serial number
4 Storage amp Handling Per Unit Certificate of Calibration Testing
Review CDC Requirement
Certificates of calibration testing provide confidence that the temperature monitoring device is measuring temperaturesaccurately All units storing VFC vaccines must have a calibrated temperature monitoring device with a current and valid certificateof calibration testing All certificates must contain modeldevice name or number serial number date of calibration testing (report or issue date) and Instrument Passed testingInstrument in Tolerance (Recommended uncertainty = +-05ordm C (+-1ordm F))
Question 45
Note to Reviewer
A
B
C
D
E
Review the certificate of calibration testing for the temperature monitoring device in this section of the storage unit and answer the questions below
bull How to determine certificate of calibration testing expiration date 1) Identify the certificate issuecalibration date 2) Apply the Immunization Program-required frequency for calibration testing Example If the
issuecalibration date is 12312013 and Immunization Program policy requires testing every twoyears the expiration date is 12312015
bull Certificates must include all of the below bull ModelDevice Name or Number bull Serial Number bull Date of Calibration Testing (Report or Issue Date) bull Instrument Passed testing (Instrument in Tolerance)
Is there a certificate of calibration testing for the temperature monitoring Yes device in this section of the storage unit No [X]
What is the date of calibration for the temperature monitoring device in this section of the storage unit
What is the certificatersquos date of expiration based on ImmunizationProgram policy (See note to reviewer to determine expiration date) [X] Follow-up is required if
certificate is expired
Does the certificate contain all the necessary items listed in the Note to Yes Reviewer No [X]
Who is responsible for supplying the current and valid certificate of Provider calibration for this temperature monitoring device
Date of calibration testing (report or issue date) Note If there is no expiration date the certificate expires 2 years from the date of calibration Whether the instrument passed or failed testing (or instrument in tolerancenot in tolerance)
bull Recommended element Documented uncertainty of +- 1degF [05degC]
If these elements are present the certificate is considered valid If the certificate contains information about the recommended element or the entity that issued the certificate that is helpful but not required
To determine if a certificate of calibration testing was issued by an appropriate entity check to see if the certificate indicates one or more of these items (this is the wording used to help sites evaluate if their calibration is accurate but is not required on the certificate itself to be considered valid)
bull Conforms to ISO 17025 bull Performed by an ILACMRA Signatory body accredited laboratory You can review this list of the ILAC MRA and Signatories (httpilacorgilac-mra-and-signatories)
bull Traceable to the standards maintained by NIST bull Meets specifications and testing requirements for the American Society for Testing and Materials (ASTM) Standard E2877 tolerance Class F (le 05 degC) or better
bull Includes reference to another acceptable accuracy validation method such as comparison to other traceable reference standards or tests at thermometric fixed points
Note CDC recommends that certifications be issued for the entire monitoring unit (detachable probe data logger etc) and not individual certificates for each component
IPI Advisor Manual | February 2017 Page 37
The 2017 MnVFC Site Visit Paperwork Chapter 4
For 45 E the provider is always responsible for supplying the current and valid certificate of calibration for a temperature monitoring device
bull Tip If the temperature monitoring device has a sticker on the back with the calibration date the site can usually call the company who calibrated the device and get a copy of the certificate if they donrsquot have one
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 46 4 Storage amp Handling Per Unit Probe Placement
Question 46 Is the probe properly placed in this section of the storage unit
Note to Reviewer ldquoProperlyrdquo means that the probe in a commercial or household unit is placed in a central area of the unitdirectly with the vaccines Probes should not be placed in the doors near or against the walls close to vents or on the floor of the unit The only allowable exemption related to this requirement is for providerswho have pharmaceutical storage units (built for vaccine storage) that have either (1) a built-intemperature monitoring device OR (2) a dedicated port for the probe that dictates the placement of theprobe
Answers (Choose one)
Yes No [X]
Review CDC Requirement
The probe must be placed in a central area of the section of the storage unit directly with the vaccines in order to properly measurevaccine temperature The probe should not be placed in the door near or against the walls close to vents or on the floor of theunit For pharmaceutical units with a built-in temperature monitoring device or a dedicated port for a probe that is not in thecenter of the section of the storage unit consult your Immunization Program for guidance on placement
Goal of this question Make sure the temperature monitoring device is in the best location to accurately measure the temperature of the vaccines stored in the unit
Helpful information bull The probe of the temperature monitoring device should be placed directly with the vaccines in the middle of the unit The ONLY allowable exception is for pharmaceutical storage units that have either a built-in thermometer or a dedicated port for the probe that indicates placement of the probe
bull Temperatures can vary within the unit especially household units bull Call MDH at 651-201-5522 if you have questions
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Guide (wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml)
Page 38 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 474 Storage amp Handling Per Unit Temperature Documentation
Question 47 Review the temperature documentation over the past three months for this section of the storage unit todetermine whether the provider has a process in place for properly documenting temperatures twice aday Answer the questions below
A Are there two temperature readings recorded for this section of the storage unit per day
Yes No [X]
B Is there a time date and name (or initials) recorded for each reading Yes No [X]
C What is the current temperature and minmax temperatures (if available) inthis section of the storage unit Use the reviewerrsquos thermometer if the providerrsquos temperature monitoringdevice does not have a current valid certificate of calibration testing or the probe is not properly placed in this section of the storage unit
Current Temperature Minimum Temperature Maximum Temperature Fahrenheit Celsius
D Based on your review of the providerrsquos recent temperature documentationincluding the current temperature is this section of the storage unitmaintaining appropriate temperatures
Yes No [X] Not enough information [X]
Review CDC Requirement
Vaccines must be stored under appropriate temperatures as described in the package inserts at all times Acceptable temperature ranges vary by vaccine type and the range is 36deg F and 46deg F (2deg C and 8deg C) and for frozen vaccines the range is -58deg F and +5deg F (shy50deg C and -15deg C) Exposure to temperatures outside of those included in the package inserts could affect vaccine viability andultimately could leave children unprotected against vaccine-preventable diseases In order to maintain awareness of storage unittemperatures and ensure that vaccines are being stored at appropriate temperatures at all times VFC providers are required to monitor and document temperatures for all vaccine storage units at least twice a day Temperature documentation must contain (1) at least two temperature readings per day (2) the time and date of each reading and (3) the name (or initials) of the personwho assessed and recorded the readings CDC also recommends that VFC providers record the minimum and maximumtemperatures of each unit once each workday (preferably in the morning)
Goal of this question Ensure the temperature is being monitored twice daily is within the required range and documented correctly Use your thermometer to check the temperature if the sitersquos temperature monitoring devicersquos probe is not properly placed or there is not a current certificate of calibration Place your thermometer in the unit at the beginning of the visit to allow sufficient time to reach an accurate temperature The purpose of using your thermometer is to ensure the vaccine is being stored at the proper temperature not to ldquovalidaterdquo their reading
Question 47 D is an assessment question based on information you have learned during your visit You might answer ldquonot enough informationrdquo if the unit is new and they donrsquot have at least three months of data or if the unit is only used as overflow and they are inconsistent with temperature monitoring Mark ldquoNordquo if you have reason to believe the storage unit is not maintaining temperatures properly
Helpful information bull All sites must document temperatures twice a day every day the site is open even if they have a data logger or continuous monitoring system
bull Sites can document the information electronically with some continuous monitoring systems as long as it can show what the current temp is the date time and initials of the person checking ndash this needs to be someone at the site ndash not checking remotely or centrally for a large site or system The site must be able to produce these records during their site visit Reviewing these files can be a challenge due to large volumes and lots of paper
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Temperature Logs on Managing Vaccine (wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml)
IPI Advisor Manual | February 2017 Page 39
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 484 Storage amp Handling Per Unit Temperature Excursions
Question 48 In the event that a temperature excursion(s) occurred in this unit within the last three months requestand review documentation of actions taken to determine whether the provider has a process for properlyaddressing excursions Answer the questions below
A Were vaccines in this unit exposed to out-of-range temperatures in the lastthree months (including today)
Yes No (If no skip to question 49)
B Did the provider quarantine and label vaccines as ldquoDo not userdquo Yes No [X]
C Did the provider place vaccine in a unit where it can be stored under properconditions if applicable
Yes No [X]
D Did the provider contact the Immunization Program to report theexcursion
Yes No [X]
E Was the manufacturer contacted for documentation supporting theusability of the vaccine
Yes No [X]
Review CDC Requirement
The provider must document all excursions and actions taken including the following (1) Quarantine and label vaccines as ldquoDO NOTUSErdquo (2) Place vaccines in a unit where they can be stored under proper conditions (3) Contact the Immunization Program to report an excursion and (4) Contact the vaccine manufacturer to obtain documentation supporting the usability of the vaccine
Goal of this question Address any out-of-range temperatures (temperature excursions) identified in reviewing the last three months of temperature logs or during the site visit If there were any out-of-range temperatures did the site respond appropriately to the situation This is a great opportunity to discuss what to do in the event of an excursion The Clinicians Storage and Handling Mishap Checklist is in the IPI Site Visit information folder and is a good review of the process
Helpful information bull Sites need to know that an excursion does not automatically mean that exposed vaccines are non-viable or unusable Exposed vaccines must be quarantined (marked ldquoDo Not Userdquo) and stored under proper conditions until they have received information from vaccine manufacturers regarding the viability of the vaccine
bull Sites must inform MDH when an excursion occurs
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Clinicians Storage and Handling Mishap Checklist (wwwhealthstatemnusdivsidepcimmunize ipivaxchklstpdf)
Page 40 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 49
Goal of this question Ensure proper placement of vaccines in the storage unit
Note These are all recommendations (best practices) not requirements
Helpful information bull Store vaccine in the middle of the compartment two to three inches away from the coils walls floor and cold air vent The temperature near the floor and walls of the unit differs from that in the middle of the compartment and the cold air vent can freeze refrigerated vaccines
4 Storage amp Handling Per Unit Vaccine Placement
Question 49 Look inside the unit to answer the questions below
A Are vaccines placed in the middle of the unit with space between vaccinesand the sideback of the unit to allow cold air to circulate
Yes No [O]
B Are vaccines stored in their original packages Yes No [O]
C Are there water bottles (for refrigerators) or frozen water bottles (forfreezers) in the unit
Yes No [O]
D Are vaccines store in the doors vegetable bins under or near cooling ventsor on the floor of the unit
Yes [O] No
E Is food being stored in the unit Yes [O] No
Review CDC Recommendation
Vaccines should be stored in their original manufacturer (or CDC centralized distributor) packaging They should be placed in the middle of the unit with space between the vaccines and the sideback of the unit to allow cold air to circulate Vaccines SHOULD NOT be stored in the doors vegetable bins or floor of the unit or under or near cooling vents and there should not be any food inthe unit Water bottles (for refrigerators) or frozen water bottles (for freezers) should be placed throughout each storage unit inorder to (1) stabilize or extend temperatures during a power outage and (2) to serve as physical blocks preventing the placementof vaccines in areas of the unit that are at higher risk for temperature excursions (such as in doors vegetable bins floor ornearunder cooling vents)
bull Vaccines should be kept in their original packaging to Protect them from light Help prevent medication errors by making labels easier to read Provide a moisture barrier that serves as insulation in case of an out-of-range temperature power outage door left open or mechanical failure Simplify managing vaccine inventory
bull Store water bottles in the doors on the floor and near the cold air vent in the refrigerator and frozen water bottles in the freezer to help maintain a stable temperature if there is a power failure and when the door is opened frequently Too many water bottles in the door can prevent the door from closing tightly Mark water bottles ldquoDo Not Drinkrdquo
bull Do not store vaccine in the door or drawers of the refrigerator or freezer Vegetable bins and crisper drawers should be removed from refrigerators or used to store other medical supplies or water bottles
bull If vaccine is stored in a household combination refrigeratorfreezer The top shelf should not be used for storing vaccine because the cold air vent blowing from the freezer will freeze vaccine located there If you must use the top shelf of this type of unit place water bottles underneath the cold air vent to prevent vaccine from being stored there It is recommended that only the refrigerator be used for vaccine storage and a separate stand-alone freezer be used to store frozen vaccine
bull Must not store food or beverages in the refrigerator or freezer because frequent opening of doors can lead to temperature variations that may affect vaccine viability There is also a risk of contaminating vaccines
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Guide (wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml) bull Vaccine Storage Tip Sheet on IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml)
IPI Advisor Manual | February 2017 Page 41
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 4104 Storage amp Handling Per Unit Disconnection from Power Source
Question 410 Ask the provider to demonstrate what measures are taken to ensure that vaccine storage units are notaccidentally physically disconnected from the power supply Which of the following describes the measure(s) taken on this unit
Note to Reviewer bull Large hospitals and healthcare systems may not have the ability to demonstrate labels on plugs or circuitbreakers In such cases verify that the practice has a comprehensive policy and standard operatingprocedures in place to prevent the vaccine storage unit from being physically disconnected from thepower supply
bull While back-up generators may ensure power to the overall facility this question ONLY addresses thevaccine storage unit being accidentally disconnected from the power source either through the plug orthe circuit breaker
Answers A ldquoDo not disconnectrdquo labels on the plug (Choose all that B ldquoWarningrdquo label on the circuit breaker box
apply) C Hard-wired (ie built-in) and has a ldquoDo not disconnectrdquo label on thecircuit breaker box D Hospital or large health care system with a comprehensive written policyand standard operating procedures detailing measures taken to preventvaccine storage units from being accidentally disconnected from the powersupply E No acceptable measures for preventing accidental disconnection frompower supply [X]
[X] The response is non-compliant if only A only B or E is selected
Review CDC Requirement
VFC providers must take steps to protect the power source for all vaccine storage equipment by means of having clear warninglabels on both the plug and the circuit breaker associated with all vaccine storage units Large hospitals and healthcare systems canmeet this requirement by demonstrating that they have comprehensive policies and standard operating procedures to preventvaccine storage units from being physically disconnected from the power supply
Goal of this question Decrease the chance that a vaccine storage unit will be accidently unplugged or power will be turned off while vaccine is in the unit This question addresses only what measures the site has taken to ensure the storage unit is not physically disconnected from its power source
If the site uses labels on the plugs and circuit breakers perform a visual inspection to assess whether the way the stickers are positioned make it clear and obvious to anyone that these units are not to be disconnected
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Do Not Unplug and Warning stickers are included in the folder or available to order on the For
Professionals Order Form (wwwhealthstatemnusdivsidepcimmunizeordermathtml)
Note Once you have completed the 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet for each unit return to the questionnaire to complete sections 5 and 6
Page 42 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
- -
Section 5 Storage amp Handling Site-Wide Question 51
5 Storage amp Handling Site Wide Discussion of Cost amp Quantity of Vaccine
Question 51 Have a discussion with the provider about the cost and quantity of VFC vaccines they are responsible for annually Address the points listed in the note to reviewer below
Note to Reviewer bull Vaccine Shipped (Required) Share the cost of VFC vaccines shipped to the provider in the last calendaryear to make sure the provider understands the contribution made by the VFC Program to their practiceFor new providers who do not have ldquocalendar yearrdquo data share either the actual cost of their currentinventory or use the cost of 10 VFC doses of each of the ACIP-recommended vaccines (approximately $7000) to help estimate their annual cost
bull Storage amp Handling (Required) Make sure the provider understands the cost of vaccines for which they are responsible when they make decisions about purchasing recommended vaccine storage and temperature monitoring equipment
Answer I have discussed with the provider the cost and quantity of vaccines ordered in the previous calendar year
Goal of this question Inform sites of the quantity and value of vaccines that they receive as part of the MnVFC program Providers often donrsquot realize the value of the vaccine in their unit This information is included on your clinic list and on the one page site-specific information
Helpful information bull This discussion must occur and the box on the questionnaire must be checked bull If there isnrsquot actual vaccine value information available tell the site that one vaccine order that includes a box of each of the ACIP recommended vaccines costs approximately $7000
bull MDH may not have specific information for individual sites if they receive vaccine from a central warehouse or pharmacy For those sites MDH will give you numbers for the whole system so you can discuss system wide data as appropriate If individual site information is also included it is usually just varicella-containing vaccines that must be shipped directly to the site
Question 52
5 Storage amp Handling Site Wide Dorm Style Units
Question 52 Determine whether the provider has any dorm-style units on site and answer the questions below
Note to Reviewer A dormitory-style refrigerator is a unit that has both refrigerator and freezer compartments behind a singleexterior door Dorm-style units also have an evaporator plate (cooling coil) which is usually located insidean icemaker compartment (freezer) within the refrigerator
A Does the provider have any dorm-style units that are used at any time tostore vaccines
Yes [X] No (Skip to question 53)
B Does the provider have sufficient space in existing compliant vaccinestorage units to store all vaccines without use of the dorm-style unit at any time
Yes No [X]
Review CDC Requirement
Dorm- and bar-style units are prohibited for vaccine storage Vaccines stored in dorm-style units are considered non-viable and must be returned to the centralized distributor CDC recommends the following vaccine storage unit types (in order of preference)pharmaceutical grade stand-alone or combination units (preferred) householdcommercial stand-alone unitshouseholdcommercial combination units using the refrigerator section only
Goal of this question Ensure no vaccine is stored in dorm-style units even for short periods of time Encourage them to label any units ldquoNo Vaccine Storage Allowedrdquo Vaccine stored in these units is considered non-viable If a site is using a dorm-style unit call the MnVFC program (651-201-5522)
Resource Section 8 in the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 43
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 535 Storage amp Handling Site Wide Storage Unit Space Availability
Question 53 Does the provider have sufficient room across storage units to store current stock as well as anyadditional stock acquired during peak season without overcrowding
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have sufficient storage space to accommodate vaccine stock at the busiest time of year without overcrowding
Goal of this question Ensure that sites have sufficient space in their units to maintain vaccines at the busiest time of year Overcrowding of vaccine limits air circulation and affects the unitrsquos ability to maintain stable temperatures
Helpful information bull Look for signs of overcrowding such as vaccines that are pushed up against the wall bins that are overflowing or storage units that are full during non-peak seasons
Discuss immediate actions if the unit is overcrowded Move some of their vaccines order less vaccine more frequently (once per month preferably) andor purchase another storage unit for overflow
Resource bull Section 8 MnVFC Policy and Procedure Manual
Page 44 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 545 Storage amp Handling Site Wide Expired Vaccines
Question 54 Look in each unit Are there expired vaccines in any of the vaccine storage units at this site
Answers (Choose one)
Yes [X] No
Review CDC Requirement
Vaccines should be rotated weekly and when a new shipment comes in so that longer-dated vaccines are stored behind shorter-dated vaccines If vaccines expire they can no longer be stored in the same storage unit with viable vaccines They must be placedin a container or bag clearly labeled ldquoDo not userdquo and separated from viable vaccines to prevent inadvertent use Expired vaccinemust be returned to the centralized distributor within six months of expiration
Goal of this question Ensure there is no expired vaccine in any storage unit
Helpful information bull Sites can prevent their stock from expiring by rotating vaccines every week andor when a new shipment arrives Longer-dated vaccines are stored towards the back of the unit and shorter-dated vaccines are up front
bull Pay attention to vaccines that expire within the next three months Consider transferring vaccine that will expire soon to another MnVFC-enrolled site that will use the vaccine preferably a site close by It is the transferring sitersquos responsibility to arrange the transfer of the vaccine Be sure to complete the MDH Vaccine Transfer Record form and send it to MDH If they are having difficulty finding a location to accept vaccine contact MDH
bull This is a great opportunity to educate sites about the MDH Nonviable Vaccine Form and the process for returning vaccine The VFC program does get some credit for taxes and fees on vaccine that is returned to the distribution center
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MDH Nonviable Vaccine Form and MDH Vaccine Transfer Record on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfcformshtml)
IPI Advisor Manual | February 2017 Page 45
The 2017 MnVFC Site Visit Paperwork Chapter 4
- -
-
Question 555 Storage amp Handling Site Wide Back up Thermometer
Question 55 Does the provider have a readily available back-up thermometer with a current and valid certificate ofcalibration testing
Note to Reviewer ldquoReadily availablerdquo means that the thermometer is available to perform twice-a-day monitoring for a unit asrequired CDC recommends that the back-up thermometer be maintained on site
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have a readily available back-up thermometer with a current and valid certificate of calibration testing Toprevent the certificates of calibration testing of the primary and back-up thermometers from expiring at the same time the date of calibration testing (or issue date) of the back-up thermometer should be different from the date of calibration testing (or issue date) of the primary thermometer As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meetsVFC program requirements
Goal of this question Ensure sites have one calibrated back-up thermometer onsite that is readily available in the event that the temperature monitoring device in unit fails transportation of vaccine is needed or there are other unexpected circumstances
Helpful information bull As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meets VFC Program requirements
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 56 5 Storage amp Handling Site Wide Preparation of Vaccine
Question 56 When does this provider prepare vaccine for administration to the patient
Note to Reviewer For mass vaccination clinics if one type of vaccine is offered providers may pre-draw up to 10 doses Ifusing pre-filled syringes pre-drawing also means activating the syringe by removing the needle guard orattaching a needle
Answers (Choose all that
apply)
Prepare dose immediately before administration Pre-draw doses for upcoming patients (in a regular clinicpractice) [O] Pre-draw up to 10 doses (in a mass-vaccination clinic) Pre-draw more than 10 doses (in a mass-vaccination clinic) [O] Other [O]
Review CDC Recommendation
CDC recommends preparing vaccines immediately prior to administration in order to assure viability of vaccine and prevent vaccinewastage Vaccines that are not administered immediately are at risk of exposure to temperatures outside of the required rangewhich can affect vaccine viability and ultimately can leave children unprotected against vaccine-preventable diseases
Goal of this question Discuss proper timing and preparation of vaccine(s) for administration These are recommendations not requirements
Helpful information bull Educate staff on the importance of preparing vaccine immediately before administration Pre-drawing of vaccines may lead to concerns related to vaccine viability potency sterility and wastage
Page 46 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 6 Inventory Question 61
6 Inventory Inventory Comparison
Question 61 Visually inspect storage units to determine if existing supply of vaccines proportionately mirrorspopulations served Choose the most accurate statement below
Note to Reviewer bull CDC recommends that providers maintain a four-week supply of inventory bull For this question do not take into account vaccine types that the provider does not order Here simply
make sure that overall the vaccines in the providerrsquos storage units are available in sufficient amounts toserve their patient population
Answers (Choose one)
The current vaccine inventory proportionately reflects the populations identified Only public stock is insufficient [X] Only private stock is insufficient [X] Both public and private stock are insufficient [X] Site uses the replacement method but does not appear to have enough vaccine for their population [X] Other [X]
Review CDC Requirement
VFC providers must order and stock routine vaccines in accordance with their patient population in order to prevent missedvaccination opportunities Having sufficient amounts of all stocks prevents the inadvertent use of VFC vaccines for non-VFC-eligiblepatients and vice versa
Goal of this question Assess whether the site is ordering appropriate quantities of vaccine for the population they serve at their site
Helpful information bull If the site sees 30 percent private-pay patients and 70 percent VFC the stock in their storage units should reflect that proportion If you donrsquot know you can ask the site about their population
bull This is meant to be a general assessment so in a big site if they have only a small amount of vaccine that may indicate an issue with vaccine management
bull CDC recommends smaller more frequent orders (ie monthly) rather than large orders to minimize the amount of vaccine loss if an incident occurs during shipment or in the storage unit Sites should not order more frequently than once a month
bull Sites using the replacement method will only have one stock but it should appear to be large enough for their population
bull Only assess the vaccine types that the site currently stocks in their unit We know there are sites that do not offer all ACIP-recommended vaccines for various reasons That issue will be addressed in question 62
IPI Advisor Manual | February 2017 Page 47
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 626 Inventory ACIP Recommended Vaccines
Question 62 Review providerrsquos current inventory to answer the questions below
A Does the provider offer all routine ACIP-recommendedvaccines for their patient population
Yes (Skip to question C) No [X] Offers all except varicella because direct ship ofvaccine is unavailable from manufacturer
B Which routine vaccines are NOT being offered DTaP Hepatitis A Hepatitis B HIB HPV Influenza Meningococcal
MMR Pneumococcal Polio Rotavirus TdapTd Varicella
C According to Immunization Program Policy does theprovider make accessible all non-routine ACIP-recommended vaccines for those VFC patients whomeet the criteria for receiving them
Yes (Skip to question 63) No [X]
D Which non-routine vaccines are NOT being offered Pneumococcal polysaccharide vaccine (PPSV23) Meningococcal Group B (MenB) Other
Review CDC Requirement
VFC providers agree to comply with immunization schedules dosages and contraindications that are established by the Advisory Committee on Immunization Practices (ACIP) for the vaccines identified and agreed upon in the Provider Agreement UNLESS bull In the VFC providers medical judgment and in accordance with accepted medical practice the VFC provider deems such
compliance to be medically inappropriate for the child bull The particular requirements contradict state law including laws pertaining to religious and other exemptions The VFC program entitles children to the following vaccines DTaP Hepatitis A Hepatitis B HIB HPV Influenza MeningococcalMMR Pneumococcal Polio Rotavirus TdapTd and Varicella VFC providers are also required to ensure that VFC-eligible children have access to non-routine vaccines as needed
Goal of this question Assess if the site is offering all the ACIP-recommended vaccines for the population they serve and these vaccines are in stock on the day of the visit It is important that every MnVFC-eligible child that comes to a providerrsquos office for an immunization is vaccinated
Helpful information bull The Advisory Committee on Immunization Practices (ACIP) is a group of medical and public health experts that develops recommendations on how to use vaccines to control diseases in the United States
bull Specialty providers are not required to offer all routine vaccines but should provide the vaccines appropriate for their population
bull If the site does not offer all routine ACIP-recommended vaccines appropriate for their population check the ldquoNordquo box in Part A then check the appropriate box(es) in Part B for any vaccines not offered Please contact MDH as this situation offers us the opportunity to provide education to the site
bull For non-routine vaccines they must either be in stock or the site must have an alternative protocol in the routine management plan that ensures these children have access when applicable
Resources bull IAC Diseases and Vaccines (wwwimmunizeorgvaccines) bull CDC Advisory Committee on Immunization Practices (ACIP) (wwwcdcgovvaccinesacipindexhtml)
Page 48 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 636 Inventory Separation of Stock
Question 63 Observe how the provider differentiates stock in each storage unit to answer the questions below
A Is it clear which vaccines belong to public stock andwhich belong to private stock
Yes No [X] Not applicable replacement site
B Is it clear which vaccines belong to VFC stock andwhich belong to UUAV stock
Yes No [X] Not applicable replacement site Not applicable not UUAV-enrolled site
Review CDC Requirement
In order to ensure that VFC vaccines are only administered to VFC-eligible children VFC providers that serve both VFC and non-VFCshyeligible children must maintain their vaccine inventories in such a way that they can clearly differentiate public stock from privatestock as well as VFC from other public stock
Goal of this question Assess whether the site can distinguish between MnVFC vaccine and private vaccine If they participate in the Uninsured and Underinsured Adult Vaccine (UUAV) program they should also be able to distinguish between MnVFC stock and UUAV stock Some sites use labels bins boxes etc to differentiate their stock If it is not clear how the site differentiates their stock discuss vaccine management with the staff For follow-up call MDH to discuss doing a follow-up site visit
Sites using the replacement method will not have separate stocksmdashthis is an approved alternative method for keeping track of vaccine
Resource bull Section 10 of the MnVFC Policy and Procedure Manual
IPI Advisor Manual | February 2017 Page 49
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
MnVFC Site Visit Storage and Handling Per Unit Answer Sheet 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet MnVFC PIN ___________________
Question number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
Temperature Monitoring Device Questions Questions 43 47 must be answered separately for the freezer and refrigerator if the unit is a combo Be sure to document responses in the appropriate column
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
All the questions on the Site Visit Storage amp Handling Per Unit Answer Sheet have been discussed previously in section 4 of this manual Use this sheet to record information about all the units at the site visit You will need one sheet for each unit If it is a combination unit (either pharmaceutical or household) you can record both sections on one sheet If they have stand-alone units use one sheet for each unit Do not enter the answers to the questions in section 4 of the questionnaire
If you need more information about any of the questions refer back to the main questionnairemdashthe complete question additional guidance including notes to the reviewer and the CDC requirements are there Also if the site is not meeting the requirement you will go back to the questionnaire to complete the ldquoActions if Non-compliantrdquo section including the root cause analysis and follow-up sections
When you have completed the assessment of all the storage units remember to go back to the questionnaire to complete sections 5 and 6
Page 50 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
ndash
ndash
MnVFC Provider Follow-up PlanThe goal of the Provider Follow-up Plan is to communicate with the site all of the VFC requirements any unmet requirements found during your site visit and the timeline for completing the required action The left hand column is a box to check for ldquoUnmetrdquo requirements
Helpful information bull The form can be used to review what the site is doing well and what they need to work on
bull For requirements that have specific documentation that needs to be sent to you use the notes section
2017 MnVFC Provider Follow-up Plan Site _______________________________________________ MnVFC PIN ____________ Date of Visit ___________
Thank you for participating in this MnVFC compliance site visit Please review this visit summary including follow-up actions and timelines for completion Unmet MnVFC requirements and recommendations have a checked box next to them The goal of this plan is to support you with successfully implementing the program and improving access to vaccines for VFC-eligible children
Unmet Question VFC Requirements Section 1 Changes to Key Staff
Q12 Change in the Medical Director Immunization Manager Vaccine Coordinator or back-upKey Staff must be communicated to the immunization program by emailing healthmnvfcstatemnus Changes Notes
Q12 Key staff must complete the annual training on VFC program requirements and print theAnnual Training certificate of completion Documentation Required Action
Staff that have not completed the MnVFC online training must complete it and send acopy of the certificate to the reviewer Training can be found on the MnVFC website (wwwhealthstatemnusvfc) Due date 1 month
Notes
Unmet Question VFC Requirements Section 2 Eligibility
Q21 Provider staff must possess a working knowledge of all VFC eligibility criteria and use thoseVFC Eligibility criteria to screen children prior to administering VFC vaccines
Categories Notes
bull This form provides documentation needed for follow-up actions when you send your thank you email
The second to last page of the Provider Follow-up Plan has a summary of the MnVFC program recommendations These are to remind the site about best practices they may want to improve upon even though they are not yet requirements of the program For example you could discuss the recommendation about storage units if they currently have a combination household unit and are using both sections
The last section is for your signature and the person you met with In most sites it will be the immunization manager or vaccine coordinator who signs the form unless the medical director attended the site visit You keep the original copy and the site will need to keep a copy for themselves
To be completed by the site visit reviewer
I acknowledge that a VFC site visit was performed on __________________ (visit date) The follow-up plan which includes a list of all current VFC program requirements and recommendations assessed during the visit and any required follow-up actions was provided at the end of the visit
Site visit reviewer
Phone
Reviewer Signature Date
To be completed by the provider
I acknowledge that our practice took part in the VFC site visit noted above I understand the findings of the visit and any required actions that must be taken by our office in order to meet VFC program requirements
Medical Director (or designee) Name Title
Medical Director (or designee) Signature Date
IPI Advisor Manual | February 2017 Page 51
The 2017 MnVFC Site Visit Paperwork Chapter 4
After the Site Visit Send a thank you email highlighting the unmet requirements documents you need from the site to resolve the issue(s) and the date you need them Make sure to include the link to the Site Visit Survey (httpssurveyvovicicomseashxs=56206EE334CE0B14)
Please refer to Chapter 3 for more information about future follow-up required after the visit including forms and documentation
Resource bull Sample Thank You letter on IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml)
Chapter 5
IPI Advisor Resource List MnVFC Program 651-201-5522
MnVFC wwwhealthstatemnusvfc
bull Separate Stock and Replacement Method Policies and Procedures Manuals bull Online trainings bull MnVFC Announcements sign up to receive them via email bull Ordering MDH vaccine bull MnVFC forms Screening forms Reporting forms Others MDH Nonviable Vaccine Form MDH Vaccine Transfer Record and Vaccine Borrowing Report
bull MnVFC promotional materials bull Immunization Billing Guidance for MnVFC and Immunization Billing Guidance for MnVFC Replacement Sites Immunization Practices Improvement Program (IPI) wwwhealthstatemnusdivsidepcimmunizeipi
bull IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml) bull IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml) IPI Resource Folder Contents (wwwhealthstatemnusdivsidepcimmunizeipiipifolderpdf)
Minnesota Immunization Information Connection (MIIC) wwwhealthstatemnusmiic
bull MIIC regions and regional coordinators
Clinical Practice MDH Immunization Program wwwhealthstatemnusimmunize
Got Your Shots News wwwhealthstatemnusdivsidepcnewslettersgys
MDH Immunization Information for Health Care Providers wwwhealthstatemnusdivsidepcimmunizehcp
bull Got Your Shots A Providers Guide to Immunization in Minnesota bull Vaccine protocols bull Forms for tracking patient immunizations bull Immunization schedules for Health Care Providers Immunization Action Coalition (IAC) wwwimmunizeorg
bull Ask the Experts bull VISs (Vaccine Information Statements and translations) bull Administration screening questions bull Medical management of vaccine reactions bull Order form for Californiarsquos Immunization Technique DVD Best Practices with Infants Children and Adults
Page 52 IPI Advisor Manual| February 2017
IPI Advisor Resource List Chapter 5
CDC ldquoPink Bookrdquo wwwcdcgovvaccinespubspinkbookindexhtml
CDC Advisory Committee on Immunization Practices (ACIP) wwwcdcgovvaccinesacip
CDC Vaccines and Immunizations wwwcdcgovvaccines
VAERS reporting httpvaershhsgovindex
Storage and Handling Got Your Shots Providers Guide ndash Managing Vaccine wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml
MnVFC Guide to Temperature Monitoring Devices wwwhealthstatemnusvfc
MDH Clinicianrsquos Vaccine Mishap Checklist wwwhealthstatemnusdivsidepcimmunizeipivaxchklstpdf
MDH Vaccine Storage Guide wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml
CDC Vaccine Storage and Handling Toolkit wwwcdcgovvaccinesrecsstoragetoolkit
You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Vaccine manufacturer phone numbers wwwcdcgovvaccinespubspinkbookdownloadsappendicesFcontact-info-manufactpdf
IAC Checklist for Safe Vaccine Handling and Storage wwwimmunizeorgcatgdp3035pdf
IAC Donrsquot Be Guilty of These Errors in Vaccine Storage and Handling wwwimmunizeorgcatgdp3036pdf
Additional Resources Print materials from MDH ndash order forms wwwhealthstatemnusdivsidepcimmunizeordermathtml
Vaccine Education Center ndash Childrenrsquos Hospital of Philadelphia wwwchopeduservicevaccine-education-centerhomehtml
California Department of Public Health ndash Interactive training on vaccine administration and storage and handling handout on transporting vaccine and how to package wwwezizorg
IPI Advisor Manual | February 2017 Page 53
IPI Advisor Resource List Chapter 5
CDC vaccine price list wwwcdcgovvaccinesprogramsvfcawardeesvaccine-managementprice-listindexhtml
Vaccine Information Statements (VIS) wwwcdcgovvaccineshcpvisindexhtml
CEU Opportunities CDC Immunization Education and Training wwwcdcgovvaccinesedindexhtml
Immunization You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Page 54 IPI Advisor Manual| February 2017
- Introduction
-
- Welcome to the Immunization Practice Improvement (IPI) Program
- Contact Information
-
- Chapter 1
- Requirements to Participate in the MnVFC Program
- Vaccines for Children Program
- Chapter 2
- Reimbursement for MnVFC Visits
- Types of Visits
- Your MnVFC Clinical CoordinatorPlanner
- New IPI Advisor Training Requirements
- Your Role as an IPI Advisor
- Reasons MDH Would Do All or Part of a Visit
- Chapter 3
- Future follow-up
- Conducting the Visit
- Preparing for the Visit
- Information for the Visit
- Site Visit Checklist
- Scheduling the Visit
- Chapter 4
- After the Site Visit
- MnVFC Provider Follow-up Plan
- MnVFC Site Visit Storage and Handling Per Unit Answer Sheet
- Section 6 Inventory
- Section 5 Storage amp Handling Site-Wide
- Section 4 Storage amp Handling Per Unit
- Section 3 Documentation
- Section 2 Eligibility
- Section 1 Provider Details
- The Site Visit Reviewer Legend
- MnVFC Site Visit Questionnaire
- Required Paperwork for Site Visits
- Chapter 5
-
Introduction
Welcome to the Immunization Practice Improvement (IPI) Program IPI is a component of the immunization program at the Minnesota Department of Health IPI merges key aspects of the overall immunization program at the provider level vaccine management vaccine accountability and clinical immunization practices
As an IPI advisor you will be conducting visits to sites that provide vaccines to children through the Minnesota Vaccines for Children (MnVFC) program
This manual along with the appropriate MnVFC Policies and Procedures Manual for the type of site you are visiting will provide you with the information that you need to complete these visits
The most up to date version of this manual is available on the IPI Program Resources (wwwhealth statemnusdivsidepcimmunizeipiresourceshtml) website Changes and additions will be included as they occur
By performing site visits you help ensure that children in Minnesota receive safe viable immunizations and are protected from vaccine-preventable diseases Thank you
Helpful Definitions Sites In this manual all organizations that administer vaccine to MnVFC-eligible children andor store vaccine for MnVFC-eligible children will be referred to as sites
Separate stock Method of vaccine management where sites keep privately-purchased vaccine in a separate stock from MnVFC vaccine obtained through MDH Patients eligible for MnVFC must receive vaccine from the MnVFC stock
Replacement method Method of vaccine management where sites use privately-purchased vaccine to vaccinate MnVFC-eligible children and then the MnVFC program replaces the private vaccine that was administered Only sites with grandfathered status and who have a signed replacement method agreement are allowed to use the replacement method
Parent site A parent site is a location where vaccine is ordered and delivered to be redistributed to satellite sites It is based on how the system is set up for ordering vaccine in the MnVFC ordering software This may or may not be how the site is structured as an organization The parent site orders all the vaccines for the other sites except for varicella-containing vaccines Varicella-containing vaccine must be delivered directly to the site where it will be used The parent site is responsible for the MnVFC Annual Report for itself and all of its satellite sites
Satellite site A satellite site is a site that receives redistributed vaccine from a parent site All satellite sites need to have an enrollment visit and a PIN number to receive MnVFC vaccine from the parent site Sites that are considered a satellite of another site usually have a letter at the end of the PIN to indicate that they are a satellite All vaccines except varicella-containing vaccines are ordered by the parent site for the satellite site Varicella-containing vaccines are ordered using the satellite PIN and are delivered directly to the satellite site Sites must sign a separate provider agreement for each satellite site that stores MnVFC vaccine
IPI Advisor Manual | February 2017 Page 3
Introduction cont
Federally Qualified Health Center (FQHC) A site that is located in an area of need of services Sites apply to receive this federal designation They offer a sliding scale for patients that are uninsured
Rural Health Center (RHC) A site that is located in an underserved rural area They apply to receive this federal designation
Local Public Health (LPH) Clinics are deputized in Minnesota to allow vaccination of underinsured children at their site
Contact Information Immunization Practices Improvement (IPI)
Email healthIPIinquiriesstatemnus
Website wwwhealthstatemnusdivsidepcimmunizeipiindexhtml
Minnesota Vaccine for Children (MnVFC) Program
Phone 651-201-5522
Website wwwhealthstatemnusvfc
Minnesota Department of Health 625 N Robert St (street address) PO Box 64975 (mailing address)St Paul MN 55164-0975
Page 4 IPI Advisor Manual | February 2017
Chapter 1
The Immunization Practices Improvement Program The goal of the Immunization Practices Improvement (IPI) Program is to help ensure that all eligible children receive viable vaccine at low or no cost
The Minnesota Department of Health (MDH) contracts with local public health departments to provide IPI services in their community IPI advisors from these departments complete site visits at MnVFC- enrolled sites in their county Local public health (LPH) staff often already have a relationship with primary care providers in their community and if not visits may help facilitate building relationships and sharing information Visits ensure enrolled sites meet the following objectives
bull Adhere to MnVFC eligibility and programmatic requirements and recommendations bull Manage vaccines to ensure proper storage and handling and minimize waste bull Administer and document vaccines according to current immunization guidelines
Vaccines for Children Program The Vaccines for Children (VFC) Program is a federal entitlement program which provides vaccines to children whose parents or guardians may not be able to afford them This helps ensure that all children have a better chance of getting their recommended vaccinations on schedule Vaccines available through the VFC Program are those recommended by the Advisory Committee on Immunization Practices (ACIP) (wwwcdcgovvaccinesacipindexhtml) These vaccines protect babies young children and adolescents from 16 diseases
Funding for the VFC program is approved by the Office of Management and Budget (OMB) and allocated through the Centers for Medicare amp Medicaid Services (CMS) to the Centers for Disease Control and Prevention (CDC) CDC buys vaccines at a discount and distributes it to grantees (ie state health departments) who then distribute the vaccine at no charge to enrolled sites
History of the Vaccines for Children Program
From 1989 - 1991 a measles epidemic in the United States resulted in tens of thousands of cases of measles and hundreds of deaths Upon investigation CDC found that more than half of the children who had measles had not been immunized even though many of them had seen a health care provider
In partial response to that epidemic Congress passed the Omnibus Budget Reconciliation Act (OBRA) on Aug 10 1993 creating the Vaccines for Children (VFC) Program VFC became operational Oct 1 1994 Known as section 1928 of the Social Security Act the VFC Program is an entitlement program (a right granted by law) for eligible children age 18 and younger
Minnesota Vaccines for Children Program
The Minnesota Vaccines for Children (MnVFC) program is Minnesotarsquos version of the federal VFC program By collaborating with over 820 sites throughout Minnesota MnVFC provides vaccines at no cost to children who may not otherwise be vaccinated because of the inability to pay Approximately one-third of Minnesota children are eligible for the MnVFC program These are children who are 18 years of age or younger and fall into one of the following categories
IPI Advisor Manual | February 2017 Page 5
The IPI Program Chapter 1
bull Uninsured bull Enrolled in a Minnesota Health Care Program Medical Assistance (MA) or MinnesotaCare bull American Indian or Alaskan Native or bull Underinsured children that are seen at a local health department Federally Qualified Health Center (FQHC) or Rural Health Center (RHC) Indian Health Services (IHS) and tribal health clinics
The majority of pediatric and family practice clinics are enrolled in MnVFC so children can stay with their health care home and still receive low-cost immunizations
When Congress enacted the VFC program they wanted to ensure that bull Sites manage their VFC vaccine appropriately so that there is little to no wastage of this valuable asset bull All eligible children receive the vaccine bull Immunization coverage rates increase by removing barriers to vaccination especially among high-risk children and by reducing disparities in access to health care
bull Vaccine is not used for the purpose of gaining profit for the provider or site
To assure these goals are achieved all states are required to conduct site visits for each enrolled site at least every other year As an IPI advisor you will be conducting the required MnVFC site visits in your county
Minnesota receives approximately $48 million of federally funded vaccine through the MnVFC program each year It is extremely important that these vaccines are managed properly and given only to the individuals that are eligible to receive them
Requirements to Participate in the MnVFC Program Initially providers must go through an enrollment process with MDH to receive vaccine from the MnVFC program This requires filling out the enrollment paperwork meeting the requirements in the appropriate MnVFC Policies and Procedures Manual and having an enrollment site visit by MDH staff
Following enrollment all sites receive their first MnVFC site visit within one year (preferably in 3-6 months) and then a MnVFC site visit at least every other year If you know of a provider who is not enrolled in the program a new clinic opens or if a site opens a satellite site in your county have them call the MnVFC program at 651-201-5522 to begin the enrollment process
Sites must meet many requirements to receive vaccine from the MnVFC program These requirements are identified in the MnVFC Policies and Procedures Manual There are two versions of the manual one for sites that keep separate stocks of public and private vaccine and another for sites that use the replacement method of vaccine management A copy of the appropriate manual is mailed to each site every fall The immunization manager vaccine coordinator and their back-ups must complete the annual online training based on the method of vaccine management their site uses All of the materials can be found on the MnVFC website (wwwhealthstatemnusvfc) Sites must complete the appropriate reports agreements and online training each year in order to continue to receive vaccine from the MnVFC program
Page 6 IPI Advisor Manual| February 2017
Chapter 2 IPI Advisors Your Role as an IPI Advisor As part of an MDH grant agreement with community health boards MDH contracts with local public health agencies to conduct MnVFC site visits in their county
As an IPI advisor you will be responsible for bull Attending the annual training provided by MDH bull Reviewing your county site visit lists and providing any known updates to your MnVFC clinical coordinatorplanner
bull Conducting site visits completing and submitting paper work within 10 days of the visit bull Following up with sites for unmet requirements identified at MnVFC site visits bull Notifying MDH when new sites open that will be storing and administering immunizations (in order to recruit new providers)
bull Keeping up-to-date with new recommendations and requirements for immunizations as well as the MnVFC program Read and be familiar with MnVFC and IPI web pages Sign up to receive email alerts for these resources by clicking on the red envelope at the top of these pages MnVFC Announcements (wwwhealthstatemnusdivsidepcimmunizemnvfcbfaxhtml) Got Your Shots News newsletter (wwwhealthstatemnusdivsidepcnewslettersgysindex html) Immunization Practices Improvement Program (wwwhealthstatemnusdivsidepc immunizeipiindexhtml)
Be designated as the IPI contact in Workspace (httpsoephealthstatemnusworkspace) for your organization Contact your organizationrsquos Workspace administrator to assign you this role
Annual training
Every spring MDH provides training for IPI advisors This training may be in-person or by webinar All IPI advisors are required to attend training each year to review site visit paperwork hear updates on the MnVFC program and ask questions about the process
Clinic lists
Early in the year MDH will send you a clinic list Your list will include all sites in your county that are enrolled in the MnVFC program The priority column indicates whether the IPI advisor MDH staff or the field epidemiologist should complete the visit Those sites not due for a visit that year will have the next year listed Every active MnVFC site is required to receive a site visit at least every other year You can do visits every year if you would like but this is not required Please review the list and notify your MnVFC clinical coordinatorplanner about any changes
IPI Advisor Manual | February 2017 Page 7
IPI Advisors Chapter 2
Included with the list is a one-page information sheet for each site This contains the sitersquos demographic information vaccine coordinator and immunization manager listed in our records whether they are a separate stock or replacement site and the doses and cost of vaccine they received last year Confirm this information with the site and discuss their vaccine quantity and value as part of the questionnaire during your visit
All site visits must be completed by Sept 30 2017 If you think you will be unable to complete all your visits by then you will need to contact your MnVFC clinical coordinatorplanner to determine how the visit will be completed
New IPI Advisor Training Requirements New IPI advisors need to contact MDH before performing any MnVFC site visits on their own A MnVFC clinical coordinatorplanner will help you prepare to perform site visits They will
bull Guide your training See the Training Checklist for IPI Advisors on the IPI Program Resources (wwwhealthstate mnusdivsidepcimmunizeipiresourceshtml) page
bull Have you shadow them or another experienced IPI advisor on one or two site visits bull Shadow you on a visit or two bull Complete the training document
Your MnVFC Clinical CoordinatorPlanner Your MnVFC clinical coordinatorplanner is a MDH staff member that will help support you See who your clinical coordinatorplanner is on IPI Contact Information (wwwhealthstatemnusdivsidepc immunizeipicontacthtml)
The role of the MnVFC clinical coordinatorplanner bull Provide assistance to IPI advisors bull Perform enrollment visits for new sites that will be administering MnVFC vaccine bull Review MnVFC site visit paperwork for accuracy bull Conduct MnVFC site visits where necessary bull Provide additional education or follow-up with sites bull Provide assistance and guidance regarding MnVFC requirements and recommendations to sites bull Provide training to IPI advisors and staff at MnVFC-enrolled sites bull Field storage and handling incident calls
Types of Visits MnVFC Site Visit ndash also known as the Compliance Visit
CDC requires all state immunization programs to conduct site visits to all VFC providers MnVFC site visits are required every other year but sites can be visited on a yearly basis if needed The site visit objectives are to
Page 8 IPI Advisor Manual | February 2017
IPI Advisors Chapter 2
bull Complete the MnVFC site visit paperwork found on IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml)
bull Provide education about MnVFC program requirements and recommendations to site staff bull Ensure MnVFC program requirements are properly implemented and are being met bull Provide feedback and as necessary execute corrective action bull Follow-up on identified issues bull Notify your MnVFC clinical coordinatorplanner of issues that are not resolved by the due date
Follow-Up Visit
In-person follow-up visits will not be necessary for most MnVFC site visitsmdashonly those where significant issues are identified in the original visit If you are not able to complete part of the initial site visit because you found a storage and handling incident or you found multiple issues that need to be addressed a follow-up visit may be necessary Please contact the MnVFC clinical coordinatorplanner for approval and guidance for conducting a follow-up site visit
Educational Visit
Some sites may need more information and education than you can provide during a normal site visit This may be on topics related to immunizations immunization practices or administration or storage and handling issues These visits go beyond the sharing of pamphlets resources or information that is presented at a site visit Education visits should be conducted with a group and should focus on a topic that is identified during a site visit or requested by site staff Regularly scheduled meetings are not considered educational visits Educational visits need to be approved prior to the visit by the MnVFC clinical coordinatorplanner in order for you to receive reimbursement from the MnVFC program
Unscheduled (Unannounced) Storage amp Handling Visit
Unscheduled (unannounced) visits are not pre-scheduled with the site These visits require different paperwork and focus primarily on the storage and handling portion of a MnVFC site visit The MnVFC program is required to visit 5 percent to 10 percent of enrolled sites as unannounced visits each year Please discuss any unscheduled visits you would like to do with the MnVFC clinical coordinatorplanner You should plan to complete all of your regularly scheduled visits before doing any unscheduled visits
Enrollment Visit
All sites (including satellite clinics) that receive stock or supply MnVFC vaccine must have an enrollment visit that is conducted by MDH staff As an IPI advisor you may be asked to attend the enrollment visit This is an opportunity for you to start your relationship with the site and help with follow-up that may be necessary for the site to receive MnVFC vaccine Newly enrolled sites are scheduled for their first regular site visit within the first year (preferably within 3 to 6 months) and then every other year
IPI Advisor Manual | February 2017 Page 9
IPI Advisors Chapter 2
Reimbursement for MnVFC Visits Local public health agencies are paid for the site visits they conduct MDH will reimburse participating agencies only after we receive all of the required paperwork Paperwork submitted with incorrect or missing information may delay the reimbursement
IPI program reimbursement is processed on a quarterly basis and is processed in the month following each quarter through an electronic transfer of money Your agencycounty IPI advisor contact will receive an email notification of the reimbursement
Reimbursement rates are updated annually and available on the Contracts and Reimbursements (www healthstatemnusdivsidepcimmunizeipicontreimhtml) page
2017 MnVFC Site Visit Reimbursement Rates MnVFC Site Visit $400 Follow-up Visit$150 Education Visit$100 Unscheduled Visit$300
Reasons MDH Would Do All or Part of a Visit MDH may complete site visits or accompany you on a site visit if
bull The site is new to the MnVFC program (enrollment visit) bull The site has known issues or concerns regarding the MnVFC program especially if you are having difficulty resolving these issues
bull The site is refusing a site visit from local public health or yoursquore having a difficult time scheduling a visit
bull The site is part of tribal health or Indian Health Services bull MDH district epidemiologists will perform site visits at local health departments bull A new IPI advisor needs training from MDH staff bull Note MDH district epidemiologists will perform site visits at local health departments
Page 10 IPI Advisor Manual | February 2017
Chapter 3 Site Visits Scheduling the Visit
bull Check the information sheet or contact the site to confirm who the contact person is in charge of the MnVFC program In general this is the immunization manager or vaccine coordinator If the contact is no longer there ask for the person in charge of the sitersquos vaccines or the clinic manager They can usually direct you to the appropriate person You may want to follow a suggested phone script when contacting the site
Sample Phone Script for Scheduling a Visit
ldquoHello My name is _______ I am calling from ________ Health Department May I speak to (contact name) [If not available determine appropriate person to talk to or a better time to call back] I am calling to schedule a MnVFC site visit This visit will involve a review of immunization practices at your site We will look at vaccine administration storage and handling screening for eligibility and documentation of vaccinations It usually takes about two hours for a visit depending on the number of vaccine storage units you have Is there a day or time of day that works best for you
I have a pre-visit worksheet to send to you to help you prepare for the visit It contains information about what I will need at the visit such as temperature logs and immunization documentation information Completing this worksheet prior to me arriving will help the visit be more efficient Is there any other information that I can send to help you prepare for the visit
If you have any questions call me at ________ Thank you for your time and assistance I look forward to working with yourdquo
bull Arrange a date and time for the visit bull Let them know an approximate visit length Visits are usually around two hours long depending on the size of the site the number of vaccine storage units they have or if they have new staff
bull Request that key staff be present at the visit This could include the immunization manager vaccine coordinator immunization staff clinic manager nurse manager billing staff andor medical director
bull Inform your site contact that you will be sending them an email confirmation along with the MnVFC
Pre-Visit Worksheet
Site Visit Checklist Use the Site Visit Checklist on IPI Advisor Site Visit Materials (wwwhealthstatemnusdivs idepcimmunizeipisvmaterialshtml) to make sure all necessary steps are covered
MINNESOTA VA C CI N ES FO R CHI LD REN PROGRAM
Site Visit Checklist Date of visit Time
Site Name PIN
Address
Contact Phone
Complete Before the visit Comments
Review the clinic list Identify and prioritize which sites you will visit
Email or call to schedule a date and time for the visit Ask for the immunization manager or vaccine coordinator
Email appointment confirmation attach Pre-visit Worksheet and provide instructions for returning it prior to the visit (sample email on website) Include length of the visit and which staff should be present
Add site visit to Outlook calendar and reserve a car (if needed)
Review temp logs and Pre-visit Worksheet
Send a reminder email 2-3 days ahead of the visit
IPI Advisor Manual | February 2017 Page 11
i i li
Site Visits Chapter 3
Information for the Visit2017 MnVFC Pre-Visit Worksheet Site name MnVFC PIN
Address
Medical director Email
Immunization manager Phone
Vaccine coordinator Phone
Vaccine coordinator back-up Email
IPI Site Vis t Preparat on Check st
The staff listed have completed the MnVFC online training and printed a certification of completion Immunization Manager Vaccine coordinator Vaccine coordinator back-up
Have a copy of the most recent provider agreement
Check if the above listed staff have changed since the provider agreement was completed
Check all of the vaccines administered at your site and list the corresponding publication date for each VIS you give to patients
DTaP _____________ Hepatitis A _____________ Hepatitis B _____________ Hib _____________ HPV _____________
Influenza _____________ MCV4 _____________ MMR _____________ MMR-V _____________ PCV13 _____________
Polio _____________ Rotavirus _____________ Tdap _____________ Varicella _____________
Non-Routine Vaccines Men B__________ PPSV23 _____________ Td _____________
Vaccine administration fee charged for MnVFC eligible children is $
Have a Vaccine Management and Emergency Plan that has been reviewed and dated within the last year
Have the borrowing reports if applicable for the last 12 months available at the visit
Have an anaphylaxis protocol that is clearly posted and reviewed annually
Send an appointment reminder email and the MnVFC Pre-Visit Worksheet to the MnVFC contact A sample letter and the MnVFC Pre-Visit Worksheet can be found on the IPI Advisor Site Visit Materials (wwwhealthstate mnusdivsidepcimmunizeipisvmaterialshtml) page You can request that the MnVFC Pre-Visit Worksheet and temperature logs be sent to you prior to the visit for your review
Contact the site by phone or email one or two working days before the scheduled visit to confirm your appointment This is also a good time to ask for directions and parking information if you are not familiar with the site
Preparing for the Visit Review the site visit paperwork to familiarize yourself with the questions For most of the questions there is a ldquoNote to the reviewerrdquo These notes give helpful tips about the information you are looking for when asking this question It contains the rationale for the question and which resources to provide to the site to support the rationale Some sections also require immediate on-site actionsmdashthings you must do while you are at the site and some require future follow up
bull Print copies the of site visit paperwork bull Site visit forms are available on the IPI Advisor Site Visit Materials (wwwhealthstatemnusdivs idepcimmunizeipisvmaterialshtml) page 2017 MnVFC Site Visit Questionnaire 2017 MnVFC Site Visit Storage amp Handling per Unit Answer Sheet (print one for each stand-alone andor combination storage unit at the site) 2017 MnVFC Provider Follow-up Plan (print two copies)
bull Review any previous site visit paperwork that is available You should check in with MDH staff after your visits if the site continues to have the same issues as past visits
bull Also be sure to bring Your thermometers If the sitersquos certificate of calibration is expired or the probe is not properly placed place your thermometer in the storage unit when you arrive and read the temperature just prior to reviewing the site visit findings
The MnVFC folder with additional immunization resources you wish to add (see chapter 5) and the Vaccine Storage amp Handling magnet (to order email healthIPIinquiriesstatemnus) A copy of the appropriate MnVFC Policies and Procedures Manual found on the MnVFC website (wwwhealthstatemnusvfc) Appropriate temperature logs (Celsius or Fahrenheit) Site information sheet that contains the quantity and value of the vaccine distributed to the sitesystem
Page 12 IPI Advisor Manual | February 2017
Site Visits Chapter 3
Conducting the Visit Education is a large part of the MnVFC site visit Often approaching this visit as an exchange of information with the site is more successful than a ldquoregulatoryrdquo visit Putting the staff at ease answering their questions and making a plan to address issues that arise during the visit is more helpful than a ldquopassfailrdquo attitude Education will usually consist of providing the rationale for the requirement referring to the requirement in the MnVFC Policies and Procedures Manual and providing resources to help address the situation Some questions will require additional follow-up to assure the site has corrected the issue(s) and is meeting the MnVFC requirement(s) This will be addressed further in the follow-up section
Completing the Paperwork
There are three documents that you must complete for the MnVFC site visit bull 2017 MnVFC Site Visit Questionnaire bull 2017 MnVFC Site Visit Storage amp Handling per Unit Answer Sheet (one for each storage unit) bull 2017 MnVFC Provider Follow-up Plan (two copies or you may ask them to make you a copy of the completed form for their records)
Answer the questions on the MnVFC Site Visit Questionnaire based on how things are when you arrive at the site If they correct the issue during the visit you will still mark it as an unmet requirement and document how it was addressed during the visit
The ldquoAnswerrdquo field will contain all the possible answer choices for this question For most questions answer choices will be followed by the markings below
bull Answer choices with no marking mean the site meets the CDC requirement bull Answer choices marked with an [X] indicate that this specific answer choice is non-compliant with a CDC requirement
bull Answer choices marked with an [O] indicate that this specific answer choice is not aligned with a CDC recommendation
If you marked the box with the [X] which is non-compliant with the CDC requirement conduct a root cause analysis to determine the reason for non-compliance Root cause analysis is an important component to a successful site visit It is used to identify the cause of the problem and help to resolve the issue There are several possible root causes that can be identified Choose only one root cause
bull Human cause Personal beliefsopinions Does not understand rationale of requirement Lack of concern for compliance
bull Organizational cause Competing job assignmentsworkload Lack of (insufficient) staff to perform required duties Budget limitations (for required equipment) Lack of (insufficient) training of staff Lack of (insufficient) processesprotocols
IPI Advisor Manual | February 2017 Page 13
Site Visits Chapter 3
Once identified the root cause should be documented in the questionnaire including a brief explanation of why you chose that cause This allows for follow-up with the site and a way to help find improvements to meet the unmet requirement Complete any immediate on-site action These often require providing education and resources for the site Mark the box for each action taken If you provide additional resources or information you can use the notes section to indicate the additional items
ldquoFuture follow-uprdquo are actions the site needs to take to meet the requirements of the program Wersquoll go over more specific information about the site visit questionnaire in Chapter 4
Performing the Site Visit
As you become familiar with the MnVFC program and develop a relationship with your sites you will develop a visit pattern that works for you Here is one possible sequence for conducting MnVFC site visits
bull When you arrive at the site if you have a business card it is helpful to provide it to the front desk staff person
bull When you meet with the immunization manager andor vaccine coordinator introduce yourself and explain the expectations for the visit
bull Ask to see the temperature monitoring device(s) It must have a current certificate of calibration and the probe must be properly placed in the unit If it does not meet the requirements place your thermometer in the unit at the beginning of the visit so that it has sufficient time to reach an accurate temperature by the time you complete your assessment of the storage units
bull 2017 MnVFC Site Visit Questionnaire Ask all of the questions You may have to modify the order of the questions based on what is best for the site When you get to the storage and handling section (section 4) use the answer sheet(s) to document the answers to the questions for each storage unit that stores vaccine (MnVFC or private) Do not write answers in the questionnaire unless there is an unmet requirement Be sure to ask if there is vaccine stored anywhere else at any time at this location This includes a co-located pharmacy If so these additional units will need to be assessed as well If the site has a combination refrigeratorfreezer household unit and is using both sections discuss with them the recommendation (and probable future requirement) to have a separate freezer Refer to MDH if they have further questions or need more information Be prepared to address any storage and handling mishaps that you may find A copy of the
Clinicianrsquos Vaccine Mishap Checklist is with your visit materials and the Emergency Response Worksheet is in the MnVFC Policy and Procedure Manual If you are unsure how to handle the problem call the MnVFC program at 651-201-5522 during or after the visit
Page 14 IPI Advisor Manual | February 2017
Site Visits Chapter 3
Ending the Visit bull Fill out the two copies of the 2017 MnVFC Provider Follow-up Plan (or ask them to make a copy once it is completed for their records) Indicate if they have not met the requirement by checking the box in the ldquoUnmetrdquo column If they are not meeting requirements check the required actions Review the plan with them reinforcing the positive things they are doing as well as reviewing the required follow-up action(s) Give the site a copy of the Provider Follow-up Plan Keep the signed copy of the Provider Follow-up Plan to submit with your paperwork Do not leave a copy of the Site Visit Questionnaire at the site
bull Let them know you will be sending a thank you email that will summarize the site visit Included in the email will be a survey link you would appreciate them completing regarding the visit
After the Visit bull Send the site a thank you email There is a template thank you letter on the IPI Advisor Site Visit Materials (wwwhealthstate mnusdivsidepcimmunizeipisvmaterialshtml) page Be sure you include the issues that you identified and the timeline for their completion as well as the good things you found at the visit In the template letter be sure to include the survey link The survey is very brief ndash a few questions and space to write comments
bull Either transfer your MnVFC Site Visit Questionnaire and MnVFC Site Visit Storage amp Handling per Unit Answer Sheet information to the fillable version or submit the handwritten form to MDH
Documentation of the Visit
Paperwork must be submitted to MDH within 10 days of the visit in order to meet the federal VFC programrsquos reporting requirements Do not wait to complete your follow-up before submitting the site visit paperwork
Send the following documents to MDH bull 2017 MnVFC Site Visit Questionnaire (includes the cover sheet) bull 2017 MnVFC Site Visit Storage amp Handling per Unit Answer Sheet (one for each unit) bull 2017 MnVFC Provider Follow-up Plan (original signed plan)
Submit site visit materials to bull Email healthIPIinquiriesstatemnus (preferred) bull Mail IPI Program Specialist
Immunization Practices Improvement Program Minnesota Department of HealthPO Box 64975St Paul MN 55164-0975
IPI Advisor Manual | February 2017 Page 15
Site Visits Chapter 3
Future follow-up Follow-up is an important component of the site visit It helps us ensure that the unmet requirements have been corrected The questionnaire has different time periods for follow-up depending on the question Do not wait to complete your follow-up before submitting the site visit paperwork
When you complete the Follow-Up Form make sure to keep a copy for yourself MDH also keeps track of follow-up required and will remind you if follow-up has not been completed by the deadline Most follow-up can be done with a phone call or email In-person follow-up is rarely required and should be discussed with MDH before scheduling a follow-up visit
All requirements that need follow-up are identified with a [X] on the site visit paperwork and are listed on the MnVFC Provider Follow-up Plan
bull Follow-up with the site to see how they have resolved the unmet requirements bull Document your follow-up on the Follow-Up Form available on the IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml) page If follow-up was done via letter or email a copy can be attached to the Follow-Up Form
bull Send your Follow-Up Form to MDH (healthIPIinquiriesstatemnus) with supporting documents and emails
bull If a site is not responding to your requests regarding follow-up contact your MnVFC clinical coordinatorplanner They can help with additional follow-up as needed
Page 16 IPI Advisor Manual | February 2017
Chapter 4 The 2017 MnVFC Site Visit Paperwork This chapter will go through the required MnVFC site visit paperwork with notes about information or resources to help the site address questions or issues that may arise during the visit
The MnVFC site visit paperwork is available on the IPI Advisor Site Visit Materials (wwwhealthstate mnusdivsidepcimmunizeipisvmaterialshtml) page
Please download the paperwork shortly before your visit as there may be updates and changes and this will be the most up-to-date version of the questionnaire We will send out a Workspace message with major changes
Required Paperwork for Site Visits bull 2017 MnVFC Site Visit Questionnaire bull 2017 MnVFC Storage amp Handling Per Unit Answer Sheet ndash one for each unit assessed during site
visit bull 2017 MnVFC Provider Follow-up Plan ndash with provider signature
Make sure to include the sitersquos PIN on all your paperwork Please complete and submit your site visit paperwork as soon as possible after your visit It may be helpful to schedule some time into your calendar to complete your paperwork in the days following your visit Once you have completed the post-visit follow-up send in the Follow-Up Form with documentation of the follow-up actions Please do not wait until you have completed your follow-up before sending in your initial paperwork
MnVFC Site Visit Questionnaire The questionnaire includes these six sections 1 Provider details 2 Eligibility 3 Documentation 4 Storage amp handling per unit 5 Storage amp handling site-wide 6 Inventory
IPI Advisor Manual | February 2017 Page 17
Page 18 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
The Site Visit Reviewer Legend The legend explains the formatting of the 2017 questionnaire This includes information that will be helpful in completing the site visit
Site Visit Reviewer Guide Legend
Section Number Content Area
Question number This area will always contain the text of the question
Note to reviewer The note to reviewer contains information that is necessary for properly asking and assessing responses tothe question above This may include definitions of terms requirement details and other helpful tips
Answers This field will contain all the possible answer choices for this question For most questions answer choiceswill be followed by the markings below
Answer choices marked with an [X] indicate that this specific answer choice is non-compliant with a CDC requirement Answer choices marked with an [O] indicate that this specific answer choice is not aligned with a CDC
recommendation
Review CDC RequirementRecommendation
This field will be populated with the CDC requirementrecommendation associated with the given question
Actions if Non-Compliant
Root Cause Analysis As part of the site visit reviewers are required to assess and understand the reasons why a provider office isnon-compliant with VFC program requirements ndash this is a root cause analysis Reviewers must choose theone root cause that they believe most contributes to the non-compliance Upon establishing the root causethe reviewer must provide a clear explanation of hisher findings
Immediate Action These are actions that CDC requires reviewers to take on site during the visit
Future Follow-up These are future follow-up actions (with designated due dates) that are required of the reviewer andorprovider to remedy non-compliance Reviewers must complete all follow-up in accordance with CDCestablished deadlines
Notes Information you want the VFC program to be aware of or that explains your answer in detail
bull Note to reviewer These are notes to help you understand what the question is asking for and to clarify things you might want to know when asking or rephrasing the question
bull Answers This section helps you to know when the answer does not meet the CDC requirement [X] or recommendation [O] Whenever an answer with a [X] is checked the ldquoActions if Non-compliant section must be completed The recommendations are usually good teaching points about best practices andor future requirements of the VFC program
bull Review the CDC RequirementRecommendation This section provides a specific outline of the requirement or recommendation to give you information to use in talking with the site staff
bull Actions if Non-Compliant This section describes what to do if the site is not meeting a requirement Root cause analysis This section asks you to probe beyond the surface to find what is driving the non-compliance It is intended to help uncover reasons for recurring non-compliance issues identify additional training needs and inform reviewer follow-up actions Select only one root cause and explain the particular circumstances in the space ldquoExplanation of root causerdquo line provided If there appear to be multiple issues choose the one that most contributes to the non-compliance and describe all factors in the explanation Immediate actions A list of actions to take during the site visit to address the issue Future follow-up A list of actions to take after the site visit by the set deadline
bull Notes This section can be used for notes to yourself or to MDH
IPI Advisor Manual | February 2017 Page 19
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 1 Provider Details Questionnaire Coversheet
The first page of the questionnaire collects the demographic information for the site You can use this page to help prepare for the visit Most of the demographic information about the site should be on the site-specific document you received with your clinic list You will validate that this information is current at the time of the site visit It also helps to know if this is a separate stock site or a replacement site before the visit so you can bring a copy of the appropriate MnVFC Policies and Procedure Manual
2017 MnVFC Site Visit Questionnaire Date of visit _____________ Date forms sent to MDH ______________
Site Information
Site name MnVFC PIN
Address Separate Stock Replacement
City ZIP County
Medical Director Email
Immunization Manager Phone
Vaccine Coordinator Phone
Vaccine Coordinator back-up Email
Point of contact Phone
Personnel at site visit
On this page bull The date of the visit and the date when you send these forms to MDH This information helps us track the timeliness of our review and data entry process
bull The vaccine management method used by the site (replacement or separate stock) bull The name and email of the medical director (ideally this is the person who signed the MnVFC
Program Provider Agreement)bull Contact information for the immunization manager vaccine coordinator vaccine coordinator back-up and point-of-contact for this visit The immunization manager vaccine coordinator vaccine coordinator back-up roles are
described in the MnVFC Policies and Procedure Manual The vaccine coordinator back-up may be the immunization manager or another staff person depending on the size of the site and available personnel The Point of Contact is the person you set up the appointment with signs the Provider Follow-
up Plan and receives the follow-up email This may be one of the people listed above
The Post Visit Steps section is a reminder to you about what needs to done after the visit The Education on Immunization Best Practices for Sites section reminds you to provide the resource folder to the site
Page 20 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 12
1 Provider Details Changes to Key Staff
Question 12 Ask the provider about changes to key staff to answer the questions below
A (Choose all that
apply)
At the time of the visit is the Medical Director the same individual that signed the ProviderAgreement and are the Immunization Manager and Vaccine Coordinator the same asthose last reported to the program
Yes No the Medical Director has changed No the Immunization Manager has changed No the Vaccine Coordinator has changed
B (Choose one)
Were all changes communicated to theImmunization Program according to yourprogramrsquos policy
Yes or no staff changes No [X]
C (Choose one)
Based on review of the trainingdocumentation have the current Immunization Manager Vaccine Coordinator and back-up completed all required training
Yes No [X]
Review CDC Requirement
All changes in key staff must be communicated to the Immunization Program in the manner and timeframe defined by theImmunization Program Key staff include the Medical Director or equivalent who signed the Provider Agreement the Immunization Manager Vaccine Coordinator and the back-up VFC providers are required to ensure that all key staff are fully trained on VFC program requirements at all times All training must be documented
Goal of this question Determine if there are new staff in key positions at the site and to make sure staff are properly educated about the MnVFC program A This information can help you determine the level of knowledge and experience the staff have with the MnVFC program Follow-up throughout the visit can be tailored for various levels of staff experience Likewise you may identify additional training needs for new staff
B When sites notify us of changes in key personnel we update their information in MIIC and on the clinic lists We also send the new staff information for completing the online training and direct them to read the appropriate MnVFC Policies and Procedures Manual If the answer to this part is no update the demographic area of the questionnaire and inform the staff that in the future they must notify the MnVFC program (via email or phone) if the immunization manager or vaccine coordinator changes Resource Section 12 of the MnVFC Policies and Procedures Manual
C Annual training must be verified by looking at the certificates for the online training If the answer to this part is no refer the staff to complete the appropriate MnVFC online training found on the MnVFC website (wwwhealthstatemnusvfc) for their program (separate stockreplacement) for the current year and send you a copy of the certificate within 30 days
Resource bull Sections 12 and 14 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 21
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 2 Eligibility Question 21
Goal of this Question Assess whether staff correctly understand which patients are eligible for the MnVFC program Screening ensures that eligible children receive the vaccines that they are entitled to receive under the MnVFC program and helps to prevent fraud or abuse of the program
Children 18 years and younger in these
categories can receive MnVFC vaccine at any enrolled site bull Uninsured bull Enrolled in a Minnesota Health Care Program (MHCP) Medical Assistance (MA) or MinnesotaCare bull American Indian or Alaskan Native
The following categories are considered underinsured and are only MnVFC-eligible at local public health (LPH) Federally Qualified Health Centers (FQHC) Rural Health Centers (RHC) Indian Health Services (IHS) and tribal health clinics
bull Has health insurance that does not cover one or more vaccines as can be the case with newly licensed vaccines that arenrsquot yet covered (MnVFC-eligible for non-covered vaccines only)
bull Has health insurance that caps vaccine coverage at a certain amount Once that amount is reached the child is MnVFC-eligible
Children with insurance that does not cover vaccines until a deductible has been met are considered to be fully insured and are not MnVFC-eligible
Helpful information bull Sites are not required to verify the patientrsquos response to the screening questions For example if a patient states they lost their insurance the site does not need to call the patientrsquos insurance company to confirm
If the site cannot correctly describe the eligibility categories provide educational materialsresources on MnVFC eligibility requirements
Resources bull Patient Eligibility Screening Record on MnVFC Forms (wwwhealthstatemnusdivsidepc immunizemnvfcformshtml)
bull Section 1 of the MnVFC Policies and Procedures Manual
2 Eligibility VFC Eligibility Categories
Question 21 Was the individual responsible for determining patient VFC eligibility able to explain all the factors(including age) that make a child eligible to receive VFC vaccines
A Patient is less than 19 years of age Yes No [X]
B Patient is Medicaid-eligible Yes No [X]
C Patient is uninsured Yes No [X]
D Patient is underinsured Yes No [X]
E Patient is American Indian Yes No [X]
F Patient is Alaska Native Yes No [X]
Review CDC Requirement
VFC providers must possess a working knowledge of all VFC eligibility criteria and use those criteria to screen children prior toadministering VFC vaccines In order to receive VFC vaccine a patient must be under the age of 19 and must be at least one of the following (1) Medicaid-eligible (2) Uninsured (ie child has no health insurance) (3) Underinsured (ie child has health insurancebut coverage does not cover any or certain vaccines ndash underinsured children may only receive VFC vaccines in FQHCRHC ordeputized VFC provider offices and only for vaccines not covered by insurance) and (4) American Indian or Alaska Native (AIAN)
Page 22 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 22
2 Eligibility Billing Practices
Question 22 Is the individualdepartment responsible for billing able to clearly explain how they bill for both the costof vaccine and the vaccine administration fee for each of the eligibility categories below
A Medicaid-eligible Cost of Vaccine Do not bill ndash provided by VFC Admin Fee Bill Medicaid
Yes No [X]
B Uninsured Cost of Vaccine Do not bill ndash provided by VFC Admin Fee If billing can bill patient
Yes No [X]
C Underinsured Cost of Vaccine Do not bill ndash provided by VFC through FQHCsRHCs or deputized providers only all other providers cannotprovide VFC vaccine to underinsured patients Admin Fee If billing can bill patient
Yes No [X]
D American IndianAlaska Native(AIAN)
Cost of Vaccine Do not bill - provided by VFC unless patient is fully insured and parent chooses to use insurance Admin Fee If patient is Medicaid-eligible bill Medicaid if billingand patient is uninsuredunderinsured can bill patient if parentchooses to use private insurance for cost of vaccine billpatientinsurance
Yes No [X]
E Do individuals responsible for billing have access to the results of eligibility screening toensure proper billing
Yes No [X]
Review CDC Requirement
VFC providers must adhere to proper billing practices for vaccine administration fees and clearly understand that VFC vaccine isprovided at no cost to both the VFC provider and eligible children At no time should billing occur for the cost of VFC vaccine Whenadministering VFC vaccine providers should never bill two different ldquopayersrdquo (ie patient Medicaid insurance) for the samevaccine administration fee amount For Medicaid-eligible children Medicaid should be billed for the vaccine administration fee Forall other VFC-eligible populations the patient may be billed within the stateterritory cap established by the Centers for Medicareand Medicaid (CMS) However patients cannot be turned away or reported to collections for inability to pay the administration fee
Goal of this question Determine if the staff correctly understand how to bill patients that are eligible for the MnVFC program Billing appropriately ensures that children can receive low cost immunizations and the site is in compliance with the VFC program
bull If there is any indication that sites could be billing insurance companies or parents for VFC vaccines this should be investigated further
bull Most sites in Minnesota will bill Medicaid with the SL modifier ndash which indicates this is a Medicaid claim
bull The main point is to ensure the site is not billing uninsured children for VFC vaccine and are not charging them more than $2122 per vaccine for the administration fee
bull Non-compliance is usually unintentional and may be resolved with some training In rare cases it could be a glimpse into a larger problem where a site is intentionally billing for financial gain
bull If you think the site is billing inappropriately it is the responsibility of the IPI advisor to report concerns to MDH staff for further assistance
Resources bull Immunization Billing Guidance for MnVFC (wwwhealthstatemnusdivsidepcimmunizemnvfc billingtipshtml) or Immunization Billing Guidance for MnVFC Replacement Method Sites (www healthstatemnusdivsidepcimmunizemnvfcreplacementbillingtipsrephtml)
bull Section 2 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 23
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 232 Eligibility Vaccine Administration Fee
Question 23 Document the actual vaccine administration fee charged to non-Medicaid VFC-eligible patients (confirmwith billing department)
Answers Fee $ [X] Follow-up is required if the provider charges more than the fee cap establishedby the Centers for Medicare and Medicaid (CMS) for your stateterritory ($2122)
Review CDC Requirement
The VFC providerrsquos vaccine administration fee for non-Medicaid VFC-eligible children must not exceed the stateterritory vaccineadministration fee cap established by the Centers for Medicare and Medicaid (CMS) For current fee caps refer to Medicaid Program Payments for Services Furnished by Certain Primary Care Physicians and Charges for Vaccine Administration Under theVaccines for Children Program Final Rule (httpwwwgpogovfdsyspkgFR-2012-11-06pdf2012-26507pdf)
Goal of this question Ensure that sites are not charging more than the federal allowable vaccine administration fee of $2122
bull The Centers for Medicaid and Medicare (CMS) establishes a maximum fee that sites can charge to non-Medicaid-eligible VFC patients in each stateterritory for vaccine administration Health Plans usually negotiate this fee with the site but Medicaid will not pay more
bull If a parent cannot pay the vaccine administration fee the patient cannot be turned away or reported to collections VFC-eligible children must be vaccinated regardless of their ability to pay
bull If the person with whom you are conducting the site visit does not know the exact fee charged to non-Medicaid VFC-eligible patients ask to speak to someone who can verify the exact amount
bull If they are charging more than $2122 for the administration fee ndash please contact MDH staff for help with addressing this situation
Resources bull Immunization Billing Guidance for MnVFC (wwwhealthstatemnusdivsidepcimmunizemnvfc billingtipshtml) or Immunization Billing Guidance for MnVFC Replacement Method Sites (www healthstatemnusdivsidepcimmunizemnvfcreplacementbillingtipsrephtml)
bull Section 2 of the MnVFC Policies and Procedures Manual
Page 24 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 3 Documentation Question 31
3 Documentation Eligibility Screening amp Documentation
Question 31 To answer the questions below the provider must clearly demonstrate the patient intake processReview a minimum of 10 records that contain an immunization visit within the last 6 ndash 12 months
Note to Reviewer Criteria for Record Selection 1) Record selection must be completely random and the provider must not know prior to the visit which
records will be reviewed 2) Patient must have been 0-19 years of age at the last visit (Note Records of 19-year-old patients may
allow you to see if VFC vaccines are being used beyond the allowable age) 3) Must review a mix of public and private-pay patients (if applicable)
A Does the provider have a process that ensures that patients are screened forVFC eligibility at each visit and that screening results are documented at each visit
Yes No [X] (If no skip question F)
B Does the providerrsquos process ensure that staff administering vaccine know which vaccine stock to select from prior to drawing the vaccine
Yes No [X]
C Number of records reviewed If fewer than 10 records are reviewed select the reason why Provider does not have 10 patient records with immunizations in last 12 months
D Do all records contain date of the immunization visit and patientrsquos date of birth Yes No [X]
E Do all records contain the patientrsquos specific eligibility status associated with thedate of the immunization
Yes No [X]
F Do any of the providerrsquos records contain any evidence that the patient received vaccine for which they were not eligible
Yes [X] No
Review CDC Requirement
VFC providers must screen for and document VFC eligibility at each immunization visit Documentation must include the date of the visit and the childrsquos specific eligibility category VFC providers must use screening results to ensure that only VFC-eligible children receive VFC vaccine and that administration fees are billed for as appropriate Eligibility status must be readily available to staff administering vaccine prior to selecting which vaccine stock to use
Goal of this question Ensure the site is screening for eligibility and documenting the eligibility category in the medical record
Review a minimum of 10 records from within the last 6-12 months where the patient received an immunization You must review a mix of public and private pay patients (if applicable)
Random selection is important If the staff have pre-selected records for review do not use and identify additional randomly selected records to review
Helpful information bull Discuss upgrading the electronic health record to make documentation of VFC eligibility screening a required field Documenting eligibility screening in the immunization field promotes better MIIC data
bull Q 31 B Sites using the replacement method of vaccine management only have one stock so you will answer ldquoYesrdquo to this question
Resources bull Patient Eligibility Screening Record on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfcformshtml)
bull Section 1 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 25
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 32
3 Documentation Vaccine Dose Documentation
Question 32 Review a minimum of 10 patient immunization records from the last six months (or 12 months ifnecessary) to assess compliance with documentation requirements set forth by Statute 42 US Code 300aa-25 (See note to reviewer below)
Note to Reviewer Criteria for Record Selection 1) Record selection must be completely random the Provider must not know prior to the visit which records
will be reviewed 2) Patient must have been 0-19 years of age at the last visit (Note Records of 19-year-old patients may allow
you to see if VFC vaccines are being used beyond the allowable age)
Records are Compliant if they Contain ALL the Below Elements
bull Address of clinic where vaccine was administered bull Publication date of VIS bull Name of vaccine administered bull Name of vaccine manufacturer bull Date vaccine was administered bull Lot number bull Date VIS was given bull Name and title of person who administered the
vaccine
A Number of records reviewed
B Number of records that contain ALL required documentation elements
If fewer than 10 records are reviewed select the reason why Provider does not have 10 patient records with immunizations in last 12 months
[X] Follow-up isrequired if one ormore records do not meet requirements
Goal of this question Assess whether the site is documenting all required information in each patientrsquos medical record for every vaccine dose administered in accordance with the National Childhood Vaccine Injury Act
Resources bull Section 6 of the MnVFC Policies and Procedures Manual bull National Vaccine Injury Compensation Program (wwwhrsagovvaccinecompensation)
Question 33
3 Documentation Record Retention
Question 33 Is the provider able to demonstrate (preferred) or clearly describe how they maintain historical VFCeligibility documentation for three years
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers are required to maintain all records related to the VFC program for a minimum of three years (or longer if requiredby state law) and upon request make these records available for review VFC records include but are not limited to VFC screening and eligibility documentation billing records medical records that verify receipt of vaccine vaccine ordering records and vaccinepurchase and accountability records
Goal of this question Make sure the site understands they are required to keep all MnVFC screening documentation for at least three years either electronically or on paper This information should be available to you at the time of the visit and future visits
Resource bull Section 7 of the MnVFC Policies and Procedures Manual
Page 26 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 34
3 Documentation Borrowing Documentation
Question 34 Discuss borrowing practices with the provider to answer the questions below
Note to Reviewer bull To be considered ldquofully documentedrdquo documentation for each borrowed dose must include thefollowing information
Vaccine type borrowed Date the dose was administered Stock used (VFC or private) Reason appropriate vaccine stock was not used Patient name and date of birth Date dose was returned to appropriate stock
A Did the provider state that they had borrowed any vaccines (whetherdocumented or not) since the last VFC Compliance Site Visit
Yes No (If no skip to question 36)
B Are there any doses for which there is no documentation (ie provider hasindicated that doses were borrowed but cannot verify how many or why)
All doses are documented Some doses are not documented [X] No doses are documented [X] (if nodoses documented skip toquestion 36)
C Were all borrowed doses fully documented (See Note to Reviewer above) Yes No [X]
D Were all borrowed VFC doses either replaced or an order submitted to replacethe doses Yes No [X]
Review CDC Requirement
VFC providers are expected to maintain an adequate inventory of vaccine for VFC and non-VFC-eligible patients It is theresponsibility of the VFC provider to appropriately schedule and place vaccine orders VFC providers must also rotate stock to ensure timely use of short-dated vaccines Borrowing of vaccine between private and public inventories must be a rare unplanned occurrence and cannot serve as a replacement system for a VFC providerrsquos privately purchased vaccine inventory All instances ofborrowing must be properly documented reported and replaced
Goal of this question Assess vaccine accountability by verifying that children are receiving vaccine from the appropriate stock
Borrowing is when a fully insured child receives a dose of MnVFC vaccine or a MnVFC-eligible child receives a dose of private vaccine This should be a rare unplanned occurrence The site must document any borrowing of vaccine between stocks ideally on the VFC Borrowing Report Form If they are not currently using the form review it with them and encourage them to post it close to their vaccines It does not need to be sent to MDH but should be kept for 3 years and filed with their MnVFC documents to be reviewed whenever they have a regular or unscheduled (unannounced) site visit
Helpful information bull Understand and report on staffrsquos verbal (ie anecdotal) accounts of borrowing obtained during the visit Often sites do not know that what they do is considered borrowing or they think borrowing is acceptable and documentation isnrsquot needed so long as those vaccines are eventually replaced
bull Since sites using the replacement method only have one stock of vaccine they very rarely borrow bull This question asks for future follow-up in 6 months Make a note on your calendar and ask them to send you a copy of their borrowing reports for the previous 6 months with documentation of doses borrowed and replaced We will remind you if we donrsquot hear from you at the 6 month time frame Complete the Follow-up Form and attach the borrowing form
Resources bull Vaccine Borrowing Report on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfc formshtml)
bull Section 10 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 27
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 353 Documentation Borrowing Reasons
Question 35 Based on your discussion with the provider and a review of borrowing reports document the dosesborrowed for each reason and answer the questions below
Note to Reviewer bull Short-dated vaccines are doses that are likely to expire before they can be used bull Exchanging short-dated vaccines should only occur in practices that have a small number of private
patients
A Reasons for Borrowing a VFC Dose (Enter the number of _____ Private vaccine shipment delay (order placed on time but delay in shippingreceipt)
vaccine doses borrowed for each
reason in the spaces
_____ Private vaccine not useable on arrival (vials broken temperature monitor out of range) _____ Ran out of private vaccine between orders (provider orders not placed on time) [X]
provided) _____ Short-dated private dose was exchanged with VFC stock _____ Accidental use of VFC dose for a private patient (human error) _____ Replacement of private dose with VFC when insurance plan did not cover vaccine _____ OtherDocumented dose did not include reason for borrowing [X]
(Explanation Required) Reasons for Borrowing a Private Dose _____ VFC vaccine shipment delay (order placed on time but delay in shippingreceipt) _____ VFC vaccine not useable on arrival (vials broken temperature monitor out of range) _____ Ran out of VFC stock between orders (provider orders not placed on time) [X] _____ Short-dated VFC vaccine dose was exchanged with private dose _____ Accidental use of a private dose for a VFC-eligible patient (human error) _____ OtherDocumented dose did not include reason for borrowing [X]
(Explanation Required)
B Enter date range for instances of borrowing reviewed in the borrowing report Note If ldquoDate of earliest instancerdquo is not available use the date of the last VFC Compliance Visit If ldquoDate of last instancerdquo is not available use the date of thecurrent VFC Compliance Visit
Date of earliest instance
Date of last instance
C Does borrowing appear to be a routine practice Note To determine whether borrowing is a routine practice assess frequency of and repeating reasons for borrowing Examples Frequent accidental use of incorrect stock exchanging short-dated vaccines or issues with ordering and shipment
Yes [X] No
Goal of this question Determine the reasons why the site is borrowing vaccine
If sites are using the Vaccine Borrowing Report review the reasons for borrowing to help document borrowed VFC andor private doses If they have not been documenting borrowing on this report (or any other form) estimate their borrowing practices If you do not know the date range for their borrowing use the last site visit date to the current visit date The use of ldquootherrdquo as the reported reason for borrowing should be rare if ever and would require explanation and follow up
Helpful information bull Look to see if they routinely maintain insufficient amounts or types of vaccine to support their public and private patients that leads to borrowing
bull Pay attention to borrowing cases documented as ldquoaccidentalrdquo Repetitive accidental borrowing may indicate an issue with ordering processes or insufficient staff training
bull Borrowing is not a place to document wasted or lost doses bull The time period of the borrowing may give you clues about the root cause Were the borrowed doses concentrated in a short period or spread out across several months or a year Are all vaccine types being borrowed or just one
bull If borrowing seems to be an issue discuss vaccine management ordering procedures
Resources bull Vaccine Borrowing Report on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfc formshtml)
bull Section 10 in the MnVFC Policies and Procedures Manual
Page 28 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 36
3 Documentation Vaccine Management Plan
Question 36 Physically review the providerrsquos Vaccine Management Plan to answer the question below
A Does the provider have a Vaccine Management Plan Yes No [X] (If no skip to question 37)
B Does the plan list the current Immunization Manager Vaccine Coordinator andback-up
Yes No [X]
C Does the plan address proper vaccine storage and handling practices Yes No [X]
D Does the plan specify vaccine receiving procedures Yes No [X]
E Does the plan contain procedures for what to do with vaccine in the event of an emergency
Yes No [X]
F Does the plan contain procedures for vaccine ordering Yes No [X]
G Does the plan address inventory control (example stock rotation) Yes No [X]
H Does the plan address how to handle vaccine wastage Yes No [X]
I Does the plan address staff training and documentation on vaccine managementstorage amp handling
Yes No [X]
J Does the plan contain a review date that falls within the last 12 months Yes No [X]
K Has the plan been signed by the individual responsible for its content Yes No [X]
Review CDC Requirement
VFC providers must develop maintain and implement a Vaccine Management Plan for routine and emergency vaccinemanagement The plan must contain the current Vaccine Coordinator and back-up proper storage and handling practicesshipping and receiving procedures emergency procedures procedures for vaccine ordering inventory control (eg stock rotation)how to handle vaccine wastage and staff trainingdocumentation on vaccine management storage and handling The plan must bereviewedupdated annually or more frequently if changes occur A ldquoreview daterdquo and signature are required on all plans in order tovalidate that they are current
Goal of this question Evaluate the sitersquos plan for vaccine management It is especially important that they have a plan for emergency management of their vaccine in the case of equipment failure or power outage Encourage all sites to read and sign the MnVFC Policies and Procedures Manual and complete the emergency plan or be able to show you a plan of their own
If the provider is not able to physically show you the plan at the time of the visit or if the recorded review date is not within the last 12 months you must mark that this requirement is unmet The Vaccine Management Plan is important in times of emergency and it should be easy to access by any staff member at any time Encourage them to post the plan and put a copy with the packing supplies
Helpful information bull Encourage the site to fill in the ldquoImmunization Managerrdquo and ldquoVaccine Coordinatorrdquo fields in the
MnVFC Policies and Procedures Manual for their own referencebull The emergency plan in the manual can be reviewed from last year and included in this yearrsquos manual (with an updated signature and date) if there have not been any changes
bull If information in the plan is outdated site staff will not be well equipped to safely manage vaccines in the event of a power-outage or other emergency situation
bull If their institutional policy is only reviewed and updated every 3-4 years (as many are) the staff may need to sign the MnVFC Polices and Procedure Manual to meet this requirement
Resource Routine Vaccine Management Plan and Emergency Vaccine Management Plan in the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 29
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 37
3 Documentation VIS amp VAERS
Question 37 Review the providerrsquos Vaccine Information Statements (VISs) and discuss providerrsquos VAERS process toanswer the questions below
A Does the provider have readily available up-to-date VISs for all ACIP-recommendedvaccines relevant to the populations it serves
Yes No [X]
B Does the provider make a VIS available for patientsparents before eachvaccination
Yes No [X]
C Does the provider know how and when to report clinically significant adverseevents using VAERS
Yes No [X]
Review CDC Requirement
VFC providers are required to distribute the current Vaccine Information Statements (VIS) each time a vaccine is administered and maintain records in accordance with the National Childhood Vaccine Injury Act (NCVIA) which includes reporting clinicallysignificant adverse events to the Vaccine Adverse Event Reporting System (VAERS) For a list of current VISs visit CDCrsquos Vaccine Information Statements (httpwwwcdcgovvaccineshcpvis) website
Gal of this question Ensure the site has the most current VISs and is giving them to each patientparent before administering the vaccine in compliance with the federal law Parents must be educated about the vaccine their child will receive and be aware of possible contraindications and side-effects in order to make well-informed decisions about their childrsquos health
Helpful information bull Ask to see the sitersquos VISs to determine if they have an active protocol for giving VISs to parents Review to make sure they are current Ask if they know where and how to report vaccine adverse events
Resources bull Section 3 in the MnVFC Policies and Procedures Manual bull CDC Vaccine Information Statements (wwwcdcgovvaccineshcpvisindexhtml) Site may sign up for email updates for the current list of VIS publication dates for the most up-to-date version
bull IAC Itrsquos Federal Law You must give your patients current Vaccine Information Statements (wwwimmunizeorgcatgdp2027pdf)
bull VAERS (httpsvaershhsgovindex)
Question 38
3 Documentation Anaphylaxis protocol
Question 38 Does the site have an anaphylaxis protocol which is clearly posted near the emergency kit
Answers (Choose one)
Yes No [X]
Review CDC Requirement
An anaphylaxis protocol must be clearly posted in the area where vaccines are administered
Goal of this question Make sure site is prepared for a severe allergic or anaphylactic reaction to a vaccine
Resources bull Section 11 in the MnVFC Policies and Procedures Manual bull IAC protocols Child and Teens (wwwimmunizeorgcatgdp3082apdf) and Adults (wwwimmunize orgcatgdp3082pdf)
Page 30 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
i
i i i - li i i i i i l
Section 4 Storage amp Handling Per Unit The goal of this section is to assess vaccine storage
2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet practices in each unit at the site MnVFC PIN ___________________
The 2017 MnVFC Storage amp Handling Per Unit Answer Sheet is a worksheet to document the answers to the questions in this section for each unit (combination or stand-alone) Fill in the answers to the questions in Section 4 on the answer sheet not in the questionnaire
The answer sheet has an abbreviated form of each question If you need further information on that question refer back to the full questionnaire Also if you find an area where the site is not meeting the requirements you will need to go back to that question on the 2017 MnVFC Site Visit Questionnaire to complete ldquoActions if Non- compliantrdquo section including the root cause analysis and follow-up sections If there is a problem in more than one unit make a note on the questionnaire which unit you are referring to in the Notes section
Important You must fully assess any unit that may be used to store VFC vaccines even if there are no VFC vaccines there on the day of the visit If there are no vaccines and the site is not documenting twice a day temperatures discuss the need to ensure the unit is maintaining stable temperatures by monitoring for one week before placing vaccines in the unit
Quest on number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
for the freezer and e co umn
Temperature Monitoring Dev refr gerator f the un
ce Quest ons Quest ons 4 3 4 7 must be answered separate y t s a combo Be sure to document responses n the appropr at
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
44D Data downloaded and reviewed routinely (eg weekly)
Yes No [O]
Yes No [O]
45A Certificate of Calibration Testing Yes No [X]
Yes No [X]
45B Date of calibration
45C Date certificate expires [X] Follow-up is required if expired [X] Follow-up is required if expired
45D Certificate contains all necessary items
Yes No [X]
Yes No [X]
46 Probe properly placed Yes No [X]
Yes No [X]
47A Two temperature readings per day
Yes No [X]
Yes No [X]
47B Time date and name (or initials) for each reading
Yes No [X]
Yes No [X]
47C Current temperature and minmax temperatures (if
Current ________deg Minimum ________deg Maximum _deg
Current ________deg Minimum ________deg Maximum _deg
Sections 5 and 6 contain questions about storage and handling site wide and inventory It is helpful to keep those questions in mind as you assess the individual storage units Think about dorm-style units expired vaccine vaccine supply room for vaccine stocking all the recommended vaccines and separation of stock if appropriate
NOTE The sections that follow require reviewers to validate responses by looking at vaccine storage units temperaturemonitoring equipment and the vaccine inventory inside a unit bull For section 4 use a separate Storage amp Handling Per Unit Answer Sheet for each unit to document the findings (combination
units using both sections can be documented on the same answer sheet) bull When an unmet requirement is identified return to this questionnaire to complete the ldquoActions if Non-compliantrdquo section for
that question bull After you complete one answer sheet for each unit return to the questionnaire to complete sections 5 and 6 using information
you gathered while assessing the units The questions in sections 5 and 6 (Storage amp Handling Site-Wide and Inventory) are notunit-specific but do require that the response be based on a thorough assessment of all the providersrsquo units
4 Storage amp Handling Per Unit
Description On the Storage amp Handling Per Unit Answer Sheet place a name that will allow you or someone else from your program to easily identify this unit in the event of follow-up We recommend using Brand + Location(example Samsung - Room 123) Save each Storage amp Handling Per Unit Answer Sheet with the Brand + Location in the file name
(example SamsungRoom123doc)
IPI Advisor Manual | February 2017 Page 31
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 41
4 Storage amp Handling Per Unit Storage Unit Build amp Use
Question 41 Below select the build and use of the vaccine storage unit you are assessing
Note to Reviewer Dorm-style units Do not add dorm-style units here Dorm-style units will be addressed in section 5 Units storing only private stock You must review these storage units even if they contain only private stockat the time of the visit because that vaccine could be administered to VFC patients
A What type of unit is this A Stand-alone B Combination
B Select use if stand-alone A Freezer B Refrigerator
Select use if combination A Use both sections to store vaccine B Use freezer section only to store vaccine C Use refrigerator section only to store vaccine
Goal of this question Identify the unit you are evaluating The description asks you to create a unique name for this unit so that you will be able to identify the same unit in future site visits Put this description on the top of the answer sheet (ie make and location)
Helpful information bull A stand-alone unit is either a refrigerator or a freezer It does not have both sections in the unit bull If there is a combination unit note if the site uses both the refrigerator and freezer or only one section of the unit to store vaccines CDC does not recommend the use of either section or the freezer section only of combination household units
bull If your site utilizes the separate stock method of vaccine management you must review storage units even if they contain only private stock at the time of the visit because there is a chance that those vaccines could be administered (borrowed) to VFC-eligible patients
Page 32 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 424 Storage amp Handling Per Unit CDC Recommended Storage Units
Question 42 Below document the grade of the vaccine storage unit you are assessing
Note to Reviewer Pharmaceutical Also called ldquopurpose-builtrdquo these units are designed by the manufacturer specifically tostore vaccines or other biological materials Commercial Although usually intended to store food and beverages commercial units are often larger and more powerful than the household units found in most homes Though these units are intended to meet thehigher demands of larger facilities these units are not specifically built for the storage of biologicalmaterials Household (non-commercialdomestic) These units are usually smaller than commercial units and areintended for use in small offices and in homes ndash typically for food storage However just like commercialunits they are not designed specifically for the storage of biological materials Such units are usually available in common home supply stores
Answers (Choose one)
Select grade A Pharmaceutical B CommercialHousehold
[O] CDC does not recommend the use of both sections or the freezer section only of combination commercialhousehold units
Review CDC Recommendation
CDC recommends the following vaccine storage unit types (in order of preference) pharmaceutical grade stand-alone orcombination units (preferred) householdcommercial stand-alone units householdcommercial combination units using therefrigerator section only
Goal of this question Assess the grade and type of each storage unit bull Pharmaceutical grade units may be stand-alone or combination units that are often metal may have glass in the door for viewing inside often have an external digital temperature display and are manufactured by medical companies
bull Commercial or household units often look like your kitchen appliance have vegetablemeat drawers in the unit and are manufactured by household appliance companies
bull Occasionally you might find a medical grade unit which is usually a commercialhousehold unit with a lock and 3-prong plug These are still considered household units because of their ability to maintain proper temperatures and air flow Studies show that household stand-alone units are better able to maintain consistent temperatures than their combination counterparts Combination household units used to store vaccine in both sections of the unit is no longer recommended and may be prohibited in the future Combination household storage units that are having difficulty maintaining a cold enough freezer temperature and a warm enough refrigerator temperature should be replaced or a separate stand-alone freezer should be purchased
For frozen vaccines the most cost effective solution is for the site to purchase a small stand-alone freezer The site may need time to budget for a stand-alone storage unit
Resources bull Replacing Combination Household Units Tip Sheet on IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml)
IPI Advisor Manual | February 2017 Page 33
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 434 Storage amp Handling Per Unit Temperature Monitoring Device in the Unit
Question 43 Determine whether there is a temperature monitoring device in this section of the storage unit andanswer the questions
A Is there a temperature monitoring device in this section of thestorage unit
Yes No [X] (If no skip to question 47)
B Who is responsible for supplying the temperature monitoring device in this section of the storage unit Provider
Review CDC Requirement
Certificates of calibration testing provide confidence that the temperature monitoring device is measuring temperaturesaccurately All units storing VFC vaccines must have a calibrated temperature monitoring device with a current and valid certificateof calibration testing All certificates must contain modeldevice name or number serial number date of calibration testing (report or issue date) and Instrument Passed testingInstrument in Tolerance (Recommended uncertainty = +-05ordm C (+-1ordm F))
Goal of this question Assess whether there is a temperature monitoring device in the unit If the unit is not being monitored at all call MDH at 651-201-5522 for guidance
Helpful information bull This question does not ask whether the temperature monitoring device is working or the characteristics of the device These issues will be addressed later in the questionnaire
bull For part B the provider is always responsible for supplying the temperature monitoring device Even if their thermometer or data logger was originally from MDH it is their responsibility to ensure it is functional and calibrated
Resources bull Section 8 in the MnVFC Policies and Procedures Manual
Page 34 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 444 Storage amp Handling Per Unit CDC Recommended Temperature Monitoring Device
Question 44 Assess the temperature monitoring device in this section of the storage unit to answer the questionsbelow
A Is the temperature monitoring device a continuous monitoring and recordingdevice (eg data logger)
Yes No [O] (Skip D)
B Does the temperature monitoring device have a probe in buffered material Yes No [O]
C Does the temperature monitoring device have a digital display that can beeasily read from the outside of this unit
Yes No [O]
D Is data downloaded and reviewed routinely Yes No [O]
Review CDC Recommendation
As of Jan 1 2018 all VFC providers must use continuous temperature monitoring devices (eg data loggers) to monitor vaccinesthat will be administered to VFC-eligible children Routine review and accessibility of temperature data is critical for determining whether vaccine has been properly stored and for assessing usability of vaccine that was involved in a temperature excursion Tomeet VFC Program requirements the device must also be equipped with bull A temperature probe bull An active temperature display that can be easily read from the outside of the unit bull The capacity for continuous monitoring and recording capabilities where the data can be routinely downloaded
The following are additional recommended features for these devices bull Alarm for out-of-range temperatures bull Current minimum and maximum temperatures display bull Low battery indicator bull Accuracy of +- 1degF (05degC) bull Memory storage of at least 4000 readings bull User programmable logging interval (or reading rate) recommended at a maximum time interval of every 30 minutes bull Use of a probe that best reflects the temperature of the vaccine (such as a buffered probe)
Goal of this question Assess the temperature monitoring device in the storage unit Note that these are all recommendations not requirements at this time
This is a great teaching opportunity for sites who do not currently have a continuous temperature monitoring device Beginning Jan 1 2018 all units that store MnVFC vaccine will be required to have a continuous temperature monitoring device (ie a data logger or a continuous temperature monitoring system) Unlike a minmax thermometer a continuous temperature monitoring device provides detailed information on all temperatures recorded at pre-set intervals For excursions it can provide information on when a temperature went out-of-range for how long and what the temperatures were This is essential information that vaccine manufacturers need to know to assess the viability of the vaccine following an excursion
Helpful information bull Sites are required to monitor and record temperatures twice daily however temperature excursions can easily occur in the 12 hours or longer between readings Continuous temperature monitoring can help manufacturers determine vaccine viability
bull Continue to encourage sites to document and evaluate minimum and maximum temperatures the storage unit reached since the last reading and respond appropriately to out-of-range temperatures
IPI Advisor Manual | February 2017 Page 35
The 2017 MnVFC Site Visit Paperwork Chapter 4
bull It is recommended that sites download and review data weekly Discuss with sites that reviewing temperature monitoring device data also includes responding appropriately if they identify out-of-range temps
bull There is sometimes confusion about the difference between a data logger and a continuous temperature monitoring system Here are some differences
Data Loggers Continuous Monitoring Systems Have an external display similar to thermometers May or may not have an external display Have a detachable probe Probe is usually attached to transmitter Need to be plugged into the computer or cradle to download information on a regular schedule
Wirelessly sends data to computer system
Create a file of data that needs to be saved on the computer
Data is stored within the system not a separate file
Doesnrsquot allow documentation of twice a day temperature checks in the file
May allow documentation of twice a day temperature checks within the system
More about the 2018 requirement for a continuous temperature monitoring device
Required Features bull The continuous temperature monitoring device must have Continuous monitoring and recording capabilities to track and record temperatures over time The capacity to routinely download temperature data to a computer (recommended at least weekly) or wirelessly transmit data Detachable probe in a bottle filled with a thermal buffer (eg bio-safe glycol) if the data logger needs to be detached in order to download data Active temperature display
Recommended Features bull MnVFC recommends continuous temperature monitoring devices with Alarm for out-of-range temperatures Accuracy within +-1degF (+- 05degC) Low battery indicator Display of current minimum and maximum temperatures Memory storage of at least 4000 readings User programmable logging intervals (eg the user can set how often the device records the temperature)
Note that these are all currently recommendations not requirements yet
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Page 36 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 45
Goal of this question Ensure the temperature monitoring device is properly calibrated The certificate of calibration testing means that the device has been tested and it is accurately measuring temperatures within established testing limits The certificate of calibration ensures that the device meets all the required components
Helpful information bull The provider is always responsible for having a current certificate of calibration (or copy) on-site
bull To be considered ldquovalidrdquo a certificate of calibration must contain these required elements Modeldevice name or number Serial number
4 Storage amp Handling Per Unit Certificate of Calibration Testing
Review CDC Requirement
Certificates of calibration testing provide confidence that the temperature monitoring device is measuring temperaturesaccurately All units storing VFC vaccines must have a calibrated temperature monitoring device with a current and valid certificateof calibration testing All certificates must contain modeldevice name or number serial number date of calibration testing (report or issue date) and Instrument Passed testingInstrument in Tolerance (Recommended uncertainty = +-05ordm C (+-1ordm F))
Question 45
Note to Reviewer
A
B
C
D
E
Review the certificate of calibration testing for the temperature monitoring device in this section of the storage unit and answer the questions below
bull How to determine certificate of calibration testing expiration date 1) Identify the certificate issuecalibration date 2) Apply the Immunization Program-required frequency for calibration testing Example If the
issuecalibration date is 12312013 and Immunization Program policy requires testing every twoyears the expiration date is 12312015
bull Certificates must include all of the below bull ModelDevice Name or Number bull Serial Number bull Date of Calibration Testing (Report or Issue Date) bull Instrument Passed testing (Instrument in Tolerance)
Is there a certificate of calibration testing for the temperature monitoring Yes device in this section of the storage unit No [X]
What is the date of calibration for the temperature monitoring device in this section of the storage unit
What is the certificatersquos date of expiration based on ImmunizationProgram policy (See note to reviewer to determine expiration date) [X] Follow-up is required if
certificate is expired
Does the certificate contain all the necessary items listed in the Note to Yes Reviewer No [X]
Who is responsible for supplying the current and valid certificate of Provider calibration for this temperature monitoring device
Date of calibration testing (report or issue date) Note If there is no expiration date the certificate expires 2 years from the date of calibration Whether the instrument passed or failed testing (or instrument in tolerancenot in tolerance)
bull Recommended element Documented uncertainty of +- 1degF [05degC]
If these elements are present the certificate is considered valid If the certificate contains information about the recommended element or the entity that issued the certificate that is helpful but not required
To determine if a certificate of calibration testing was issued by an appropriate entity check to see if the certificate indicates one or more of these items (this is the wording used to help sites evaluate if their calibration is accurate but is not required on the certificate itself to be considered valid)
bull Conforms to ISO 17025 bull Performed by an ILACMRA Signatory body accredited laboratory You can review this list of the ILAC MRA and Signatories (httpilacorgilac-mra-and-signatories)
bull Traceable to the standards maintained by NIST bull Meets specifications and testing requirements for the American Society for Testing and Materials (ASTM) Standard E2877 tolerance Class F (le 05 degC) or better
bull Includes reference to another acceptable accuracy validation method such as comparison to other traceable reference standards or tests at thermometric fixed points
Note CDC recommends that certifications be issued for the entire monitoring unit (detachable probe data logger etc) and not individual certificates for each component
IPI Advisor Manual | February 2017 Page 37
The 2017 MnVFC Site Visit Paperwork Chapter 4
For 45 E the provider is always responsible for supplying the current and valid certificate of calibration for a temperature monitoring device
bull Tip If the temperature monitoring device has a sticker on the back with the calibration date the site can usually call the company who calibrated the device and get a copy of the certificate if they donrsquot have one
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 46 4 Storage amp Handling Per Unit Probe Placement
Question 46 Is the probe properly placed in this section of the storage unit
Note to Reviewer ldquoProperlyrdquo means that the probe in a commercial or household unit is placed in a central area of the unitdirectly with the vaccines Probes should not be placed in the doors near or against the walls close to vents or on the floor of the unit The only allowable exemption related to this requirement is for providerswho have pharmaceutical storage units (built for vaccine storage) that have either (1) a built-intemperature monitoring device OR (2) a dedicated port for the probe that dictates the placement of theprobe
Answers (Choose one)
Yes No [X]
Review CDC Requirement
The probe must be placed in a central area of the section of the storage unit directly with the vaccines in order to properly measurevaccine temperature The probe should not be placed in the door near or against the walls close to vents or on the floor of theunit For pharmaceutical units with a built-in temperature monitoring device or a dedicated port for a probe that is not in thecenter of the section of the storage unit consult your Immunization Program for guidance on placement
Goal of this question Make sure the temperature monitoring device is in the best location to accurately measure the temperature of the vaccines stored in the unit
Helpful information bull The probe of the temperature monitoring device should be placed directly with the vaccines in the middle of the unit The ONLY allowable exception is for pharmaceutical storage units that have either a built-in thermometer or a dedicated port for the probe that indicates placement of the probe
bull Temperatures can vary within the unit especially household units bull Call MDH at 651-201-5522 if you have questions
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Guide (wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml)
Page 38 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 474 Storage amp Handling Per Unit Temperature Documentation
Question 47 Review the temperature documentation over the past three months for this section of the storage unit todetermine whether the provider has a process in place for properly documenting temperatures twice aday Answer the questions below
A Are there two temperature readings recorded for this section of the storage unit per day
Yes No [X]
B Is there a time date and name (or initials) recorded for each reading Yes No [X]
C What is the current temperature and minmax temperatures (if available) inthis section of the storage unit Use the reviewerrsquos thermometer if the providerrsquos temperature monitoringdevice does not have a current valid certificate of calibration testing or the probe is not properly placed in this section of the storage unit
Current Temperature Minimum Temperature Maximum Temperature Fahrenheit Celsius
D Based on your review of the providerrsquos recent temperature documentationincluding the current temperature is this section of the storage unitmaintaining appropriate temperatures
Yes No [X] Not enough information [X]
Review CDC Requirement
Vaccines must be stored under appropriate temperatures as described in the package inserts at all times Acceptable temperature ranges vary by vaccine type and the range is 36deg F and 46deg F (2deg C and 8deg C) and for frozen vaccines the range is -58deg F and +5deg F (shy50deg C and -15deg C) Exposure to temperatures outside of those included in the package inserts could affect vaccine viability andultimately could leave children unprotected against vaccine-preventable diseases In order to maintain awareness of storage unittemperatures and ensure that vaccines are being stored at appropriate temperatures at all times VFC providers are required to monitor and document temperatures for all vaccine storage units at least twice a day Temperature documentation must contain (1) at least two temperature readings per day (2) the time and date of each reading and (3) the name (or initials) of the personwho assessed and recorded the readings CDC also recommends that VFC providers record the minimum and maximumtemperatures of each unit once each workday (preferably in the morning)
Goal of this question Ensure the temperature is being monitored twice daily is within the required range and documented correctly Use your thermometer to check the temperature if the sitersquos temperature monitoring devicersquos probe is not properly placed or there is not a current certificate of calibration Place your thermometer in the unit at the beginning of the visit to allow sufficient time to reach an accurate temperature The purpose of using your thermometer is to ensure the vaccine is being stored at the proper temperature not to ldquovalidaterdquo their reading
Question 47 D is an assessment question based on information you have learned during your visit You might answer ldquonot enough informationrdquo if the unit is new and they donrsquot have at least three months of data or if the unit is only used as overflow and they are inconsistent with temperature monitoring Mark ldquoNordquo if you have reason to believe the storage unit is not maintaining temperatures properly
Helpful information bull All sites must document temperatures twice a day every day the site is open even if they have a data logger or continuous monitoring system
bull Sites can document the information electronically with some continuous monitoring systems as long as it can show what the current temp is the date time and initials of the person checking ndash this needs to be someone at the site ndash not checking remotely or centrally for a large site or system The site must be able to produce these records during their site visit Reviewing these files can be a challenge due to large volumes and lots of paper
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Temperature Logs on Managing Vaccine (wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml)
IPI Advisor Manual | February 2017 Page 39
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 484 Storage amp Handling Per Unit Temperature Excursions
Question 48 In the event that a temperature excursion(s) occurred in this unit within the last three months requestand review documentation of actions taken to determine whether the provider has a process for properlyaddressing excursions Answer the questions below
A Were vaccines in this unit exposed to out-of-range temperatures in the lastthree months (including today)
Yes No (If no skip to question 49)
B Did the provider quarantine and label vaccines as ldquoDo not userdquo Yes No [X]
C Did the provider place vaccine in a unit where it can be stored under properconditions if applicable
Yes No [X]
D Did the provider contact the Immunization Program to report theexcursion
Yes No [X]
E Was the manufacturer contacted for documentation supporting theusability of the vaccine
Yes No [X]
Review CDC Requirement
The provider must document all excursions and actions taken including the following (1) Quarantine and label vaccines as ldquoDO NOTUSErdquo (2) Place vaccines in a unit where they can be stored under proper conditions (3) Contact the Immunization Program to report an excursion and (4) Contact the vaccine manufacturer to obtain documentation supporting the usability of the vaccine
Goal of this question Address any out-of-range temperatures (temperature excursions) identified in reviewing the last three months of temperature logs or during the site visit If there were any out-of-range temperatures did the site respond appropriately to the situation This is a great opportunity to discuss what to do in the event of an excursion The Clinicians Storage and Handling Mishap Checklist is in the IPI Site Visit information folder and is a good review of the process
Helpful information bull Sites need to know that an excursion does not automatically mean that exposed vaccines are non-viable or unusable Exposed vaccines must be quarantined (marked ldquoDo Not Userdquo) and stored under proper conditions until they have received information from vaccine manufacturers regarding the viability of the vaccine
bull Sites must inform MDH when an excursion occurs
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Clinicians Storage and Handling Mishap Checklist (wwwhealthstatemnusdivsidepcimmunize ipivaxchklstpdf)
Page 40 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 49
Goal of this question Ensure proper placement of vaccines in the storage unit
Note These are all recommendations (best practices) not requirements
Helpful information bull Store vaccine in the middle of the compartment two to three inches away from the coils walls floor and cold air vent The temperature near the floor and walls of the unit differs from that in the middle of the compartment and the cold air vent can freeze refrigerated vaccines
4 Storage amp Handling Per Unit Vaccine Placement
Question 49 Look inside the unit to answer the questions below
A Are vaccines placed in the middle of the unit with space between vaccinesand the sideback of the unit to allow cold air to circulate
Yes No [O]
B Are vaccines stored in their original packages Yes No [O]
C Are there water bottles (for refrigerators) or frozen water bottles (forfreezers) in the unit
Yes No [O]
D Are vaccines store in the doors vegetable bins under or near cooling ventsor on the floor of the unit
Yes [O] No
E Is food being stored in the unit Yes [O] No
Review CDC Recommendation
Vaccines should be stored in their original manufacturer (or CDC centralized distributor) packaging They should be placed in the middle of the unit with space between the vaccines and the sideback of the unit to allow cold air to circulate Vaccines SHOULD NOT be stored in the doors vegetable bins or floor of the unit or under or near cooling vents and there should not be any food inthe unit Water bottles (for refrigerators) or frozen water bottles (for freezers) should be placed throughout each storage unit inorder to (1) stabilize or extend temperatures during a power outage and (2) to serve as physical blocks preventing the placementof vaccines in areas of the unit that are at higher risk for temperature excursions (such as in doors vegetable bins floor ornearunder cooling vents)
bull Vaccines should be kept in their original packaging to Protect them from light Help prevent medication errors by making labels easier to read Provide a moisture barrier that serves as insulation in case of an out-of-range temperature power outage door left open or mechanical failure Simplify managing vaccine inventory
bull Store water bottles in the doors on the floor and near the cold air vent in the refrigerator and frozen water bottles in the freezer to help maintain a stable temperature if there is a power failure and when the door is opened frequently Too many water bottles in the door can prevent the door from closing tightly Mark water bottles ldquoDo Not Drinkrdquo
bull Do not store vaccine in the door or drawers of the refrigerator or freezer Vegetable bins and crisper drawers should be removed from refrigerators or used to store other medical supplies or water bottles
bull If vaccine is stored in a household combination refrigeratorfreezer The top shelf should not be used for storing vaccine because the cold air vent blowing from the freezer will freeze vaccine located there If you must use the top shelf of this type of unit place water bottles underneath the cold air vent to prevent vaccine from being stored there It is recommended that only the refrigerator be used for vaccine storage and a separate stand-alone freezer be used to store frozen vaccine
bull Must not store food or beverages in the refrigerator or freezer because frequent opening of doors can lead to temperature variations that may affect vaccine viability There is also a risk of contaminating vaccines
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Guide (wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml) bull Vaccine Storage Tip Sheet on IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml)
IPI Advisor Manual | February 2017 Page 41
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 4104 Storage amp Handling Per Unit Disconnection from Power Source
Question 410 Ask the provider to demonstrate what measures are taken to ensure that vaccine storage units are notaccidentally physically disconnected from the power supply Which of the following describes the measure(s) taken on this unit
Note to Reviewer bull Large hospitals and healthcare systems may not have the ability to demonstrate labels on plugs or circuitbreakers In such cases verify that the practice has a comprehensive policy and standard operatingprocedures in place to prevent the vaccine storage unit from being physically disconnected from thepower supply
bull While back-up generators may ensure power to the overall facility this question ONLY addresses thevaccine storage unit being accidentally disconnected from the power source either through the plug orthe circuit breaker
Answers A ldquoDo not disconnectrdquo labels on the plug (Choose all that B ldquoWarningrdquo label on the circuit breaker box
apply) C Hard-wired (ie built-in) and has a ldquoDo not disconnectrdquo label on thecircuit breaker box D Hospital or large health care system with a comprehensive written policyand standard operating procedures detailing measures taken to preventvaccine storage units from being accidentally disconnected from the powersupply E No acceptable measures for preventing accidental disconnection frompower supply [X]
[X] The response is non-compliant if only A only B or E is selected
Review CDC Requirement
VFC providers must take steps to protect the power source for all vaccine storage equipment by means of having clear warninglabels on both the plug and the circuit breaker associated with all vaccine storage units Large hospitals and healthcare systems canmeet this requirement by demonstrating that they have comprehensive policies and standard operating procedures to preventvaccine storage units from being physically disconnected from the power supply
Goal of this question Decrease the chance that a vaccine storage unit will be accidently unplugged or power will be turned off while vaccine is in the unit This question addresses only what measures the site has taken to ensure the storage unit is not physically disconnected from its power source
If the site uses labels on the plugs and circuit breakers perform a visual inspection to assess whether the way the stickers are positioned make it clear and obvious to anyone that these units are not to be disconnected
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Do Not Unplug and Warning stickers are included in the folder or available to order on the For
Professionals Order Form (wwwhealthstatemnusdivsidepcimmunizeordermathtml)
Note Once you have completed the 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet for each unit return to the questionnaire to complete sections 5 and 6
Page 42 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
- -
Section 5 Storage amp Handling Site-Wide Question 51
5 Storage amp Handling Site Wide Discussion of Cost amp Quantity of Vaccine
Question 51 Have a discussion with the provider about the cost and quantity of VFC vaccines they are responsible for annually Address the points listed in the note to reviewer below
Note to Reviewer bull Vaccine Shipped (Required) Share the cost of VFC vaccines shipped to the provider in the last calendaryear to make sure the provider understands the contribution made by the VFC Program to their practiceFor new providers who do not have ldquocalendar yearrdquo data share either the actual cost of their currentinventory or use the cost of 10 VFC doses of each of the ACIP-recommended vaccines (approximately $7000) to help estimate their annual cost
bull Storage amp Handling (Required) Make sure the provider understands the cost of vaccines for which they are responsible when they make decisions about purchasing recommended vaccine storage and temperature monitoring equipment
Answer I have discussed with the provider the cost and quantity of vaccines ordered in the previous calendar year
Goal of this question Inform sites of the quantity and value of vaccines that they receive as part of the MnVFC program Providers often donrsquot realize the value of the vaccine in their unit This information is included on your clinic list and on the one page site-specific information
Helpful information bull This discussion must occur and the box on the questionnaire must be checked bull If there isnrsquot actual vaccine value information available tell the site that one vaccine order that includes a box of each of the ACIP recommended vaccines costs approximately $7000
bull MDH may not have specific information for individual sites if they receive vaccine from a central warehouse or pharmacy For those sites MDH will give you numbers for the whole system so you can discuss system wide data as appropriate If individual site information is also included it is usually just varicella-containing vaccines that must be shipped directly to the site
Question 52
5 Storage amp Handling Site Wide Dorm Style Units
Question 52 Determine whether the provider has any dorm-style units on site and answer the questions below
Note to Reviewer A dormitory-style refrigerator is a unit that has both refrigerator and freezer compartments behind a singleexterior door Dorm-style units also have an evaporator plate (cooling coil) which is usually located insidean icemaker compartment (freezer) within the refrigerator
A Does the provider have any dorm-style units that are used at any time tostore vaccines
Yes [X] No (Skip to question 53)
B Does the provider have sufficient space in existing compliant vaccinestorage units to store all vaccines without use of the dorm-style unit at any time
Yes No [X]
Review CDC Requirement
Dorm- and bar-style units are prohibited for vaccine storage Vaccines stored in dorm-style units are considered non-viable and must be returned to the centralized distributor CDC recommends the following vaccine storage unit types (in order of preference)pharmaceutical grade stand-alone or combination units (preferred) householdcommercial stand-alone unitshouseholdcommercial combination units using the refrigerator section only
Goal of this question Ensure no vaccine is stored in dorm-style units even for short periods of time Encourage them to label any units ldquoNo Vaccine Storage Allowedrdquo Vaccine stored in these units is considered non-viable If a site is using a dorm-style unit call the MnVFC program (651-201-5522)
Resource Section 8 in the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 43
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 535 Storage amp Handling Site Wide Storage Unit Space Availability
Question 53 Does the provider have sufficient room across storage units to store current stock as well as anyadditional stock acquired during peak season without overcrowding
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have sufficient storage space to accommodate vaccine stock at the busiest time of year without overcrowding
Goal of this question Ensure that sites have sufficient space in their units to maintain vaccines at the busiest time of year Overcrowding of vaccine limits air circulation and affects the unitrsquos ability to maintain stable temperatures
Helpful information bull Look for signs of overcrowding such as vaccines that are pushed up against the wall bins that are overflowing or storage units that are full during non-peak seasons
Discuss immediate actions if the unit is overcrowded Move some of their vaccines order less vaccine more frequently (once per month preferably) andor purchase another storage unit for overflow
Resource bull Section 8 MnVFC Policy and Procedure Manual
Page 44 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 545 Storage amp Handling Site Wide Expired Vaccines
Question 54 Look in each unit Are there expired vaccines in any of the vaccine storage units at this site
Answers (Choose one)
Yes [X] No
Review CDC Requirement
Vaccines should be rotated weekly and when a new shipment comes in so that longer-dated vaccines are stored behind shorter-dated vaccines If vaccines expire they can no longer be stored in the same storage unit with viable vaccines They must be placedin a container or bag clearly labeled ldquoDo not userdquo and separated from viable vaccines to prevent inadvertent use Expired vaccinemust be returned to the centralized distributor within six months of expiration
Goal of this question Ensure there is no expired vaccine in any storage unit
Helpful information bull Sites can prevent their stock from expiring by rotating vaccines every week andor when a new shipment arrives Longer-dated vaccines are stored towards the back of the unit and shorter-dated vaccines are up front
bull Pay attention to vaccines that expire within the next three months Consider transferring vaccine that will expire soon to another MnVFC-enrolled site that will use the vaccine preferably a site close by It is the transferring sitersquos responsibility to arrange the transfer of the vaccine Be sure to complete the MDH Vaccine Transfer Record form and send it to MDH If they are having difficulty finding a location to accept vaccine contact MDH
bull This is a great opportunity to educate sites about the MDH Nonviable Vaccine Form and the process for returning vaccine The VFC program does get some credit for taxes and fees on vaccine that is returned to the distribution center
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MDH Nonviable Vaccine Form and MDH Vaccine Transfer Record on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfcformshtml)
IPI Advisor Manual | February 2017 Page 45
The 2017 MnVFC Site Visit Paperwork Chapter 4
- -
-
Question 555 Storage amp Handling Site Wide Back up Thermometer
Question 55 Does the provider have a readily available back-up thermometer with a current and valid certificate ofcalibration testing
Note to Reviewer ldquoReadily availablerdquo means that the thermometer is available to perform twice-a-day monitoring for a unit asrequired CDC recommends that the back-up thermometer be maintained on site
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have a readily available back-up thermometer with a current and valid certificate of calibration testing Toprevent the certificates of calibration testing of the primary and back-up thermometers from expiring at the same time the date of calibration testing (or issue date) of the back-up thermometer should be different from the date of calibration testing (or issue date) of the primary thermometer As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meetsVFC program requirements
Goal of this question Ensure sites have one calibrated back-up thermometer onsite that is readily available in the event that the temperature monitoring device in unit fails transportation of vaccine is needed or there are other unexpected circumstances
Helpful information bull As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meets VFC Program requirements
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 56 5 Storage amp Handling Site Wide Preparation of Vaccine
Question 56 When does this provider prepare vaccine for administration to the patient
Note to Reviewer For mass vaccination clinics if one type of vaccine is offered providers may pre-draw up to 10 doses Ifusing pre-filled syringes pre-drawing also means activating the syringe by removing the needle guard orattaching a needle
Answers (Choose all that
apply)
Prepare dose immediately before administration Pre-draw doses for upcoming patients (in a regular clinicpractice) [O] Pre-draw up to 10 doses (in a mass-vaccination clinic) Pre-draw more than 10 doses (in a mass-vaccination clinic) [O] Other [O]
Review CDC Recommendation
CDC recommends preparing vaccines immediately prior to administration in order to assure viability of vaccine and prevent vaccinewastage Vaccines that are not administered immediately are at risk of exposure to temperatures outside of the required rangewhich can affect vaccine viability and ultimately can leave children unprotected against vaccine-preventable diseases
Goal of this question Discuss proper timing and preparation of vaccine(s) for administration These are recommendations not requirements
Helpful information bull Educate staff on the importance of preparing vaccine immediately before administration Pre-drawing of vaccines may lead to concerns related to vaccine viability potency sterility and wastage
Page 46 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 6 Inventory Question 61
6 Inventory Inventory Comparison
Question 61 Visually inspect storage units to determine if existing supply of vaccines proportionately mirrorspopulations served Choose the most accurate statement below
Note to Reviewer bull CDC recommends that providers maintain a four-week supply of inventory bull For this question do not take into account vaccine types that the provider does not order Here simply
make sure that overall the vaccines in the providerrsquos storage units are available in sufficient amounts toserve their patient population
Answers (Choose one)
The current vaccine inventory proportionately reflects the populations identified Only public stock is insufficient [X] Only private stock is insufficient [X] Both public and private stock are insufficient [X] Site uses the replacement method but does not appear to have enough vaccine for their population [X] Other [X]
Review CDC Requirement
VFC providers must order and stock routine vaccines in accordance with their patient population in order to prevent missedvaccination opportunities Having sufficient amounts of all stocks prevents the inadvertent use of VFC vaccines for non-VFC-eligiblepatients and vice versa
Goal of this question Assess whether the site is ordering appropriate quantities of vaccine for the population they serve at their site
Helpful information bull If the site sees 30 percent private-pay patients and 70 percent VFC the stock in their storage units should reflect that proportion If you donrsquot know you can ask the site about their population
bull This is meant to be a general assessment so in a big site if they have only a small amount of vaccine that may indicate an issue with vaccine management
bull CDC recommends smaller more frequent orders (ie monthly) rather than large orders to minimize the amount of vaccine loss if an incident occurs during shipment or in the storage unit Sites should not order more frequently than once a month
bull Sites using the replacement method will only have one stock but it should appear to be large enough for their population
bull Only assess the vaccine types that the site currently stocks in their unit We know there are sites that do not offer all ACIP-recommended vaccines for various reasons That issue will be addressed in question 62
IPI Advisor Manual | February 2017 Page 47
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 626 Inventory ACIP Recommended Vaccines
Question 62 Review providerrsquos current inventory to answer the questions below
A Does the provider offer all routine ACIP-recommendedvaccines for their patient population
Yes (Skip to question C) No [X] Offers all except varicella because direct ship ofvaccine is unavailable from manufacturer
B Which routine vaccines are NOT being offered DTaP Hepatitis A Hepatitis B HIB HPV Influenza Meningococcal
MMR Pneumococcal Polio Rotavirus TdapTd Varicella
C According to Immunization Program Policy does theprovider make accessible all non-routine ACIP-recommended vaccines for those VFC patients whomeet the criteria for receiving them
Yes (Skip to question 63) No [X]
D Which non-routine vaccines are NOT being offered Pneumococcal polysaccharide vaccine (PPSV23) Meningococcal Group B (MenB) Other
Review CDC Requirement
VFC providers agree to comply with immunization schedules dosages and contraindications that are established by the Advisory Committee on Immunization Practices (ACIP) for the vaccines identified and agreed upon in the Provider Agreement UNLESS bull In the VFC providers medical judgment and in accordance with accepted medical practice the VFC provider deems such
compliance to be medically inappropriate for the child bull The particular requirements contradict state law including laws pertaining to religious and other exemptions The VFC program entitles children to the following vaccines DTaP Hepatitis A Hepatitis B HIB HPV Influenza MeningococcalMMR Pneumococcal Polio Rotavirus TdapTd and Varicella VFC providers are also required to ensure that VFC-eligible children have access to non-routine vaccines as needed
Goal of this question Assess if the site is offering all the ACIP-recommended vaccines for the population they serve and these vaccines are in stock on the day of the visit It is important that every MnVFC-eligible child that comes to a providerrsquos office for an immunization is vaccinated
Helpful information bull The Advisory Committee on Immunization Practices (ACIP) is a group of medical and public health experts that develops recommendations on how to use vaccines to control diseases in the United States
bull Specialty providers are not required to offer all routine vaccines but should provide the vaccines appropriate for their population
bull If the site does not offer all routine ACIP-recommended vaccines appropriate for their population check the ldquoNordquo box in Part A then check the appropriate box(es) in Part B for any vaccines not offered Please contact MDH as this situation offers us the opportunity to provide education to the site
bull For non-routine vaccines they must either be in stock or the site must have an alternative protocol in the routine management plan that ensures these children have access when applicable
Resources bull IAC Diseases and Vaccines (wwwimmunizeorgvaccines) bull CDC Advisory Committee on Immunization Practices (ACIP) (wwwcdcgovvaccinesacipindexhtml)
Page 48 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 636 Inventory Separation of Stock
Question 63 Observe how the provider differentiates stock in each storage unit to answer the questions below
A Is it clear which vaccines belong to public stock andwhich belong to private stock
Yes No [X] Not applicable replacement site
B Is it clear which vaccines belong to VFC stock andwhich belong to UUAV stock
Yes No [X] Not applicable replacement site Not applicable not UUAV-enrolled site
Review CDC Requirement
In order to ensure that VFC vaccines are only administered to VFC-eligible children VFC providers that serve both VFC and non-VFCshyeligible children must maintain their vaccine inventories in such a way that they can clearly differentiate public stock from privatestock as well as VFC from other public stock
Goal of this question Assess whether the site can distinguish between MnVFC vaccine and private vaccine If they participate in the Uninsured and Underinsured Adult Vaccine (UUAV) program they should also be able to distinguish between MnVFC stock and UUAV stock Some sites use labels bins boxes etc to differentiate their stock If it is not clear how the site differentiates their stock discuss vaccine management with the staff For follow-up call MDH to discuss doing a follow-up site visit
Sites using the replacement method will not have separate stocksmdashthis is an approved alternative method for keeping track of vaccine
Resource bull Section 10 of the MnVFC Policy and Procedure Manual
IPI Advisor Manual | February 2017 Page 49
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
MnVFC Site Visit Storage and Handling Per Unit Answer Sheet 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet MnVFC PIN ___________________
Question number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
Temperature Monitoring Device Questions Questions 43 47 must be answered separately for the freezer and refrigerator if the unit is a combo Be sure to document responses in the appropriate column
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
All the questions on the Site Visit Storage amp Handling Per Unit Answer Sheet have been discussed previously in section 4 of this manual Use this sheet to record information about all the units at the site visit You will need one sheet for each unit If it is a combination unit (either pharmaceutical or household) you can record both sections on one sheet If they have stand-alone units use one sheet for each unit Do not enter the answers to the questions in section 4 of the questionnaire
If you need more information about any of the questions refer back to the main questionnairemdashthe complete question additional guidance including notes to the reviewer and the CDC requirements are there Also if the site is not meeting the requirement you will go back to the questionnaire to complete the ldquoActions if Non-compliantrdquo section including the root cause analysis and follow-up sections
When you have completed the assessment of all the storage units remember to go back to the questionnaire to complete sections 5 and 6
Page 50 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
ndash
ndash
MnVFC Provider Follow-up PlanThe goal of the Provider Follow-up Plan is to communicate with the site all of the VFC requirements any unmet requirements found during your site visit and the timeline for completing the required action The left hand column is a box to check for ldquoUnmetrdquo requirements
Helpful information bull The form can be used to review what the site is doing well and what they need to work on
bull For requirements that have specific documentation that needs to be sent to you use the notes section
2017 MnVFC Provider Follow-up Plan Site _______________________________________________ MnVFC PIN ____________ Date of Visit ___________
Thank you for participating in this MnVFC compliance site visit Please review this visit summary including follow-up actions and timelines for completion Unmet MnVFC requirements and recommendations have a checked box next to them The goal of this plan is to support you with successfully implementing the program and improving access to vaccines for VFC-eligible children
Unmet Question VFC Requirements Section 1 Changes to Key Staff
Q12 Change in the Medical Director Immunization Manager Vaccine Coordinator or back-upKey Staff must be communicated to the immunization program by emailing healthmnvfcstatemnus Changes Notes
Q12 Key staff must complete the annual training on VFC program requirements and print theAnnual Training certificate of completion Documentation Required Action
Staff that have not completed the MnVFC online training must complete it and send acopy of the certificate to the reviewer Training can be found on the MnVFC website (wwwhealthstatemnusvfc) Due date 1 month
Notes
Unmet Question VFC Requirements Section 2 Eligibility
Q21 Provider staff must possess a working knowledge of all VFC eligibility criteria and use thoseVFC Eligibility criteria to screen children prior to administering VFC vaccines
Categories Notes
bull This form provides documentation needed for follow-up actions when you send your thank you email
The second to last page of the Provider Follow-up Plan has a summary of the MnVFC program recommendations These are to remind the site about best practices they may want to improve upon even though they are not yet requirements of the program For example you could discuss the recommendation about storage units if they currently have a combination household unit and are using both sections
The last section is for your signature and the person you met with In most sites it will be the immunization manager or vaccine coordinator who signs the form unless the medical director attended the site visit You keep the original copy and the site will need to keep a copy for themselves
To be completed by the site visit reviewer
I acknowledge that a VFC site visit was performed on __________________ (visit date) The follow-up plan which includes a list of all current VFC program requirements and recommendations assessed during the visit and any required follow-up actions was provided at the end of the visit
Site visit reviewer
Phone
Reviewer Signature Date
To be completed by the provider
I acknowledge that our practice took part in the VFC site visit noted above I understand the findings of the visit and any required actions that must be taken by our office in order to meet VFC program requirements
Medical Director (or designee) Name Title
Medical Director (or designee) Signature Date
IPI Advisor Manual | February 2017 Page 51
The 2017 MnVFC Site Visit Paperwork Chapter 4
After the Site Visit Send a thank you email highlighting the unmet requirements documents you need from the site to resolve the issue(s) and the date you need them Make sure to include the link to the Site Visit Survey (httpssurveyvovicicomseashxs=56206EE334CE0B14)
Please refer to Chapter 3 for more information about future follow-up required after the visit including forms and documentation
Resource bull Sample Thank You letter on IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml)
Chapter 5
IPI Advisor Resource List MnVFC Program 651-201-5522
MnVFC wwwhealthstatemnusvfc
bull Separate Stock and Replacement Method Policies and Procedures Manuals bull Online trainings bull MnVFC Announcements sign up to receive them via email bull Ordering MDH vaccine bull MnVFC forms Screening forms Reporting forms Others MDH Nonviable Vaccine Form MDH Vaccine Transfer Record and Vaccine Borrowing Report
bull MnVFC promotional materials bull Immunization Billing Guidance for MnVFC and Immunization Billing Guidance for MnVFC Replacement Sites Immunization Practices Improvement Program (IPI) wwwhealthstatemnusdivsidepcimmunizeipi
bull IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml) bull IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml) IPI Resource Folder Contents (wwwhealthstatemnusdivsidepcimmunizeipiipifolderpdf)
Minnesota Immunization Information Connection (MIIC) wwwhealthstatemnusmiic
bull MIIC regions and regional coordinators
Clinical Practice MDH Immunization Program wwwhealthstatemnusimmunize
Got Your Shots News wwwhealthstatemnusdivsidepcnewslettersgys
MDH Immunization Information for Health Care Providers wwwhealthstatemnusdivsidepcimmunizehcp
bull Got Your Shots A Providers Guide to Immunization in Minnesota bull Vaccine protocols bull Forms for tracking patient immunizations bull Immunization schedules for Health Care Providers Immunization Action Coalition (IAC) wwwimmunizeorg
bull Ask the Experts bull VISs (Vaccine Information Statements and translations) bull Administration screening questions bull Medical management of vaccine reactions bull Order form for Californiarsquos Immunization Technique DVD Best Practices with Infants Children and Adults
Page 52 IPI Advisor Manual| February 2017
IPI Advisor Resource List Chapter 5
CDC ldquoPink Bookrdquo wwwcdcgovvaccinespubspinkbookindexhtml
CDC Advisory Committee on Immunization Practices (ACIP) wwwcdcgovvaccinesacip
CDC Vaccines and Immunizations wwwcdcgovvaccines
VAERS reporting httpvaershhsgovindex
Storage and Handling Got Your Shots Providers Guide ndash Managing Vaccine wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml
MnVFC Guide to Temperature Monitoring Devices wwwhealthstatemnusvfc
MDH Clinicianrsquos Vaccine Mishap Checklist wwwhealthstatemnusdivsidepcimmunizeipivaxchklstpdf
MDH Vaccine Storage Guide wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml
CDC Vaccine Storage and Handling Toolkit wwwcdcgovvaccinesrecsstoragetoolkit
You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Vaccine manufacturer phone numbers wwwcdcgovvaccinespubspinkbookdownloadsappendicesFcontact-info-manufactpdf
IAC Checklist for Safe Vaccine Handling and Storage wwwimmunizeorgcatgdp3035pdf
IAC Donrsquot Be Guilty of These Errors in Vaccine Storage and Handling wwwimmunizeorgcatgdp3036pdf
Additional Resources Print materials from MDH ndash order forms wwwhealthstatemnusdivsidepcimmunizeordermathtml
Vaccine Education Center ndash Childrenrsquos Hospital of Philadelphia wwwchopeduservicevaccine-education-centerhomehtml
California Department of Public Health ndash Interactive training on vaccine administration and storage and handling handout on transporting vaccine and how to package wwwezizorg
IPI Advisor Manual | February 2017 Page 53
IPI Advisor Resource List Chapter 5
CDC vaccine price list wwwcdcgovvaccinesprogramsvfcawardeesvaccine-managementprice-listindexhtml
Vaccine Information Statements (VIS) wwwcdcgovvaccineshcpvisindexhtml
CEU Opportunities CDC Immunization Education and Training wwwcdcgovvaccinesedindexhtml
Immunization You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Page 54 IPI Advisor Manual| February 2017
- Introduction
-
- Welcome to the Immunization Practice Improvement (IPI) Program
- Contact Information
-
- Chapter 1
- Requirements to Participate in the MnVFC Program
- Vaccines for Children Program
- Chapter 2
- Reimbursement for MnVFC Visits
- Types of Visits
- Your MnVFC Clinical CoordinatorPlanner
- New IPI Advisor Training Requirements
- Your Role as an IPI Advisor
- Reasons MDH Would Do All or Part of a Visit
- Chapter 3
- Future follow-up
- Conducting the Visit
- Preparing for the Visit
- Information for the Visit
- Site Visit Checklist
- Scheduling the Visit
- Chapter 4
- After the Site Visit
- MnVFC Provider Follow-up Plan
- MnVFC Site Visit Storage and Handling Per Unit Answer Sheet
- Section 6 Inventory
- Section 5 Storage amp Handling Site-Wide
- Section 4 Storage amp Handling Per Unit
- Section 3 Documentation
- Section 2 Eligibility
- Section 1 Provider Details
- The Site Visit Reviewer Legend
- MnVFC Site Visit Questionnaire
- Required Paperwork for Site Visits
- Chapter 5
-
Introduction cont
Federally Qualified Health Center (FQHC) A site that is located in an area of need of services Sites apply to receive this federal designation They offer a sliding scale for patients that are uninsured
Rural Health Center (RHC) A site that is located in an underserved rural area They apply to receive this federal designation
Local Public Health (LPH) Clinics are deputized in Minnesota to allow vaccination of underinsured children at their site
Contact Information Immunization Practices Improvement (IPI)
Email healthIPIinquiriesstatemnus
Website wwwhealthstatemnusdivsidepcimmunizeipiindexhtml
Minnesota Vaccine for Children (MnVFC) Program
Phone 651-201-5522
Website wwwhealthstatemnusvfc
Minnesota Department of Health 625 N Robert St (street address) PO Box 64975 (mailing address)St Paul MN 55164-0975
Page 4 IPI Advisor Manual | February 2017
Chapter 1
The Immunization Practices Improvement Program The goal of the Immunization Practices Improvement (IPI) Program is to help ensure that all eligible children receive viable vaccine at low or no cost
The Minnesota Department of Health (MDH) contracts with local public health departments to provide IPI services in their community IPI advisors from these departments complete site visits at MnVFC- enrolled sites in their county Local public health (LPH) staff often already have a relationship with primary care providers in their community and if not visits may help facilitate building relationships and sharing information Visits ensure enrolled sites meet the following objectives
bull Adhere to MnVFC eligibility and programmatic requirements and recommendations bull Manage vaccines to ensure proper storage and handling and minimize waste bull Administer and document vaccines according to current immunization guidelines
Vaccines for Children Program The Vaccines for Children (VFC) Program is a federal entitlement program which provides vaccines to children whose parents or guardians may not be able to afford them This helps ensure that all children have a better chance of getting their recommended vaccinations on schedule Vaccines available through the VFC Program are those recommended by the Advisory Committee on Immunization Practices (ACIP) (wwwcdcgovvaccinesacipindexhtml) These vaccines protect babies young children and adolescents from 16 diseases
Funding for the VFC program is approved by the Office of Management and Budget (OMB) and allocated through the Centers for Medicare amp Medicaid Services (CMS) to the Centers for Disease Control and Prevention (CDC) CDC buys vaccines at a discount and distributes it to grantees (ie state health departments) who then distribute the vaccine at no charge to enrolled sites
History of the Vaccines for Children Program
From 1989 - 1991 a measles epidemic in the United States resulted in tens of thousands of cases of measles and hundreds of deaths Upon investigation CDC found that more than half of the children who had measles had not been immunized even though many of them had seen a health care provider
In partial response to that epidemic Congress passed the Omnibus Budget Reconciliation Act (OBRA) on Aug 10 1993 creating the Vaccines for Children (VFC) Program VFC became operational Oct 1 1994 Known as section 1928 of the Social Security Act the VFC Program is an entitlement program (a right granted by law) for eligible children age 18 and younger
Minnesota Vaccines for Children Program
The Minnesota Vaccines for Children (MnVFC) program is Minnesotarsquos version of the federal VFC program By collaborating with over 820 sites throughout Minnesota MnVFC provides vaccines at no cost to children who may not otherwise be vaccinated because of the inability to pay Approximately one-third of Minnesota children are eligible for the MnVFC program These are children who are 18 years of age or younger and fall into one of the following categories
IPI Advisor Manual | February 2017 Page 5
The IPI Program Chapter 1
bull Uninsured bull Enrolled in a Minnesota Health Care Program Medical Assistance (MA) or MinnesotaCare bull American Indian or Alaskan Native or bull Underinsured children that are seen at a local health department Federally Qualified Health Center (FQHC) or Rural Health Center (RHC) Indian Health Services (IHS) and tribal health clinics
The majority of pediatric and family practice clinics are enrolled in MnVFC so children can stay with their health care home and still receive low-cost immunizations
When Congress enacted the VFC program they wanted to ensure that bull Sites manage their VFC vaccine appropriately so that there is little to no wastage of this valuable asset bull All eligible children receive the vaccine bull Immunization coverage rates increase by removing barriers to vaccination especially among high-risk children and by reducing disparities in access to health care
bull Vaccine is not used for the purpose of gaining profit for the provider or site
To assure these goals are achieved all states are required to conduct site visits for each enrolled site at least every other year As an IPI advisor you will be conducting the required MnVFC site visits in your county
Minnesota receives approximately $48 million of federally funded vaccine through the MnVFC program each year It is extremely important that these vaccines are managed properly and given only to the individuals that are eligible to receive them
Requirements to Participate in the MnVFC Program Initially providers must go through an enrollment process with MDH to receive vaccine from the MnVFC program This requires filling out the enrollment paperwork meeting the requirements in the appropriate MnVFC Policies and Procedures Manual and having an enrollment site visit by MDH staff
Following enrollment all sites receive their first MnVFC site visit within one year (preferably in 3-6 months) and then a MnVFC site visit at least every other year If you know of a provider who is not enrolled in the program a new clinic opens or if a site opens a satellite site in your county have them call the MnVFC program at 651-201-5522 to begin the enrollment process
Sites must meet many requirements to receive vaccine from the MnVFC program These requirements are identified in the MnVFC Policies and Procedures Manual There are two versions of the manual one for sites that keep separate stocks of public and private vaccine and another for sites that use the replacement method of vaccine management A copy of the appropriate manual is mailed to each site every fall The immunization manager vaccine coordinator and their back-ups must complete the annual online training based on the method of vaccine management their site uses All of the materials can be found on the MnVFC website (wwwhealthstatemnusvfc) Sites must complete the appropriate reports agreements and online training each year in order to continue to receive vaccine from the MnVFC program
Page 6 IPI Advisor Manual| February 2017
Chapter 2 IPI Advisors Your Role as an IPI Advisor As part of an MDH grant agreement with community health boards MDH contracts with local public health agencies to conduct MnVFC site visits in their county
As an IPI advisor you will be responsible for bull Attending the annual training provided by MDH bull Reviewing your county site visit lists and providing any known updates to your MnVFC clinical coordinatorplanner
bull Conducting site visits completing and submitting paper work within 10 days of the visit bull Following up with sites for unmet requirements identified at MnVFC site visits bull Notifying MDH when new sites open that will be storing and administering immunizations (in order to recruit new providers)
bull Keeping up-to-date with new recommendations and requirements for immunizations as well as the MnVFC program Read and be familiar with MnVFC and IPI web pages Sign up to receive email alerts for these resources by clicking on the red envelope at the top of these pages MnVFC Announcements (wwwhealthstatemnusdivsidepcimmunizemnvfcbfaxhtml) Got Your Shots News newsletter (wwwhealthstatemnusdivsidepcnewslettersgysindex html) Immunization Practices Improvement Program (wwwhealthstatemnusdivsidepc immunizeipiindexhtml)
Be designated as the IPI contact in Workspace (httpsoephealthstatemnusworkspace) for your organization Contact your organizationrsquos Workspace administrator to assign you this role
Annual training
Every spring MDH provides training for IPI advisors This training may be in-person or by webinar All IPI advisors are required to attend training each year to review site visit paperwork hear updates on the MnVFC program and ask questions about the process
Clinic lists
Early in the year MDH will send you a clinic list Your list will include all sites in your county that are enrolled in the MnVFC program The priority column indicates whether the IPI advisor MDH staff or the field epidemiologist should complete the visit Those sites not due for a visit that year will have the next year listed Every active MnVFC site is required to receive a site visit at least every other year You can do visits every year if you would like but this is not required Please review the list and notify your MnVFC clinical coordinatorplanner about any changes
IPI Advisor Manual | February 2017 Page 7
IPI Advisors Chapter 2
Included with the list is a one-page information sheet for each site This contains the sitersquos demographic information vaccine coordinator and immunization manager listed in our records whether they are a separate stock or replacement site and the doses and cost of vaccine they received last year Confirm this information with the site and discuss their vaccine quantity and value as part of the questionnaire during your visit
All site visits must be completed by Sept 30 2017 If you think you will be unable to complete all your visits by then you will need to contact your MnVFC clinical coordinatorplanner to determine how the visit will be completed
New IPI Advisor Training Requirements New IPI advisors need to contact MDH before performing any MnVFC site visits on their own A MnVFC clinical coordinatorplanner will help you prepare to perform site visits They will
bull Guide your training See the Training Checklist for IPI Advisors on the IPI Program Resources (wwwhealthstate mnusdivsidepcimmunizeipiresourceshtml) page
bull Have you shadow them or another experienced IPI advisor on one or two site visits bull Shadow you on a visit or two bull Complete the training document
Your MnVFC Clinical CoordinatorPlanner Your MnVFC clinical coordinatorplanner is a MDH staff member that will help support you See who your clinical coordinatorplanner is on IPI Contact Information (wwwhealthstatemnusdivsidepc immunizeipicontacthtml)
The role of the MnVFC clinical coordinatorplanner bull Provide assistance to IPI advisors bull Perform enrollment visits for new sites that will be administering MnVFC vaccine bull Review MnVFC site visit paperwork for accuracy bull Conduct MnVFC site visits where necessary bull Provide additional education or follow-up with sites bull Provide assistance and guidance regarding MnVFC requirements and recommendations to sites bull Provide training to IPI advisors and staff at MnVFC-enrolled sites bull Field storage and handling incident calls
Types of Visits MnVFC Site Visit ndash also known as the Compliance Visit
CDC requires all state immunization programs to conduct site visits to all VFC providers MnVFC site visits are required every other year but sites can be visited on a yearly basis if needed The site visit objectives are to
Page 8 IPI Advisor Manual | February 2017
IPI Advisors Chapter 2
bull Complete the MnVFC site visit paperwork found on IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml)
bull Provide education about MnVFC program requirements and recommendations to site staff bull Ensure MnVFC program requirements are properly implemented and are being met bull Provide feedback and as necessary execute corrective action bull Follow-up on identified issues bull Notify your MnVFC clinical coordinatorplanner of issues that are not resolved by the due date
Follow-Up Visit
In-person follow-up visits will not be necessary for most MnVFC site visitsmdashonly those where significant issues are identified in the original visit If you are not able to complete part of the initial site visit because you found a storage and handling incident or you found multiple issues that need to be addressed a follow-up visit may be necessary Please contact the MnVFC clinical coordinatorplanner for approval and guidance for conducting a follow-up site visit
Educational Visit
Some sites may need more information and education than you can provide during a normal site visit This may be on topics related to immunizations immunization practices or administration or storage and handling issues These visits go beyond the sharing of pamphlets resources or information that is presented at a site visit Education visits should be conducted with a group and should focus on a topic that is identified during a site visit or requested by site staff Regularly scheduled meetings are not considered educational visits Educational visits need to be approved prior to the visit by the MnVFC clinical coordinatorplanner in order for you to receive reimbursement from the MnVFC program
Unscheduled (Unannounced) Storage amp Handling Visit
Unscheduled (unannounced) visits are not pre-scheduled with the site These visits require different paperwork and focus primarily on the storage and handling portion of a MnVFC site visit The MnVFC program is required to visit 5 percent to 10 percent of enrolled sites as unannounced visits each year Please discuss any unscheduled visits you would like to do with the MnVFC clinical coordinatorplanner You should plan to complete all of your regularly scheduled visits before doing any unscheduled visits
Enrollment Visit
All sites (including satellite clinics) that receive stock or supply MnVFC vaccine must have an enrollment visit that is conducted by MDH staff As an IPI advisor you may be asked to attend the enrollment visit This is an opportunity for you to start your relationship with the site and help with follow-up that may be necessary for the site to receive MnVFC vaccine Newly enrolled sites are scheduled for their first regular site visit within the first year (preferably within 3 to 6 months) and then every other year
IPI Advisor Manual | February 2017 Page 9
IPI Advisors Chapter 2
Reimbursement for MnVFC Visits Local public health agencies are paid for the site visits they conduct MDH will reimburse participating agencies only after we receive all of the required paperwork Paperwork submitted with incorrect or missing information may delay the reimbursement
IPI program reimbursement is processed on a quarterly basis and is processed in the month following each quarter through an electronic transfer of money Your agencycounty IPI advisor contact will receive an email notification of the reimbursement
Reimbursement rates are updated annually and available on the Contracts and Reimbursements (www healthstatemnusdivsidepcimmunizeipicontreimhtml) page
2017 MnVFC Site Visit Reimbursement Rates MnVFC Site Visit $400 Follow-up Visit$150 Education Visit$100 Unscheduled Visit$300
Reasons MDH Would Do All or Part of a Visit MDH may complete site visits or accompany you on a site visit if
bull The site is new to the MnVFC program (enrollment visit) bull The site has known issues or concerns regarding the MnVFC program especially if you are having difficulty resolving these issues
bull The site is refusing a site visit from local public health or yoursquore having a difficult time scheduling a visit
bull The site is part of tribal health or Indian Health Services bull MDH district epidemiologists will perform site visits at local health departments bull A new IPI advisor needs training from MDH staff bull Note MDH district epidemiologists will perform site visits at local health departments
Page 10 IPI Advisor Manual | February 2017
Chapter 3 Site Visits Scheduling the Visit
bull Check the information sheet or contact the site to confirm who the contact person is in charge of the MnVFC program In general this is the immunization manager or vaccine coordinator If the contact is no longer there ask for the person in charge of the sitersquos vaccines or the clinic manager They can usually direct you to the appropriate person You may want to follow a suggested phone script when contacting the site
Sample Phone Script for Scheduling a Visit
ldquoHello My name is _______ I am calling from ________ Health Department May I speak to (contact name) [If not available determine appropriate person to talk to or a better time to call back] I am calling to schedule a MnVFC site visit This visit will involve a review of immunization practices at your site We will look at vaccine administration storage and handling screening for eligibility and documentation of vaccinations It usually takes about two hours for a visit depending on the number of vaccine storage units you have Is there a day or time of day that works best for you
I have a pre-visit worksheet to send to you to help you prepare for the visit It contains information about what I will need at the visit such as temperature logs and immunization documentation information Completing this worksheet prior to me arriving will help the visit be more efficient Is there any other information that I can send to help you prepare for the visit
If you have any questions call me at ________ Thank you for your time and assistance I look forward to working with yourdquo
bull Arrange a date and time for the visit bull Let them know an approximate visit length Visits are usually around two hours long depending on the size of the site the number of vaccine storage units they have or if they have new staff
bull Request that key staff be present at the visit This could include the immunization manager vaccine coordinator immunization staff clinic manager nurse manager billing staff andor medical director
bull Inform your site contact that you will be sending them an email confirmation along with the MnVFC
Pre-Visit Worksheet
Site Visit Checklist Use the Site Visit Checklist on IPI Advisor Site Visit Materials (wwwhealthstatemnusdivs idepcimmunizeipisvmaterialshtml) to make sure all necessary steps are covered
MINNESOTA VA C CI N ES FO R CHI LD REN PROGRAM
Site Visit Checklist Date of visit Time
Site Name PIN
Address
Contact Phone
Complete Before the visit Comments
Review the clinic list Identify and prioritize which sites you will visit
Email or call to schedule a date and time for the visit Ask for the immunization manager or vaccine coordinator
Email appointment confirmation attach Pre-visit Worksheet and provide instructions for returning it prior to the visit (sample email on website) Include length of the visit and which staff should be present
Add site visit to Outlook calendar and reserve a car (if needed)
Review temp logs and Pre-visit Worksheet
Send a reminder email 2-3 days ahead of the visit
IPI Advisor Manual | February 2017 Page 11
i i li
Site Visits Chapter 3
Information for the Visit2017 MnVFC Pre-Visit Worksheet Site name MnVFC PIN
Address
Medical director Email
Immunization manager Phone
Vaccine coordinator Phone
Vaccine coordinator back-up Email
IPI Site Vis t Preparat on Check st
The staff listed have completed the MnVFC online training and printed a certification of completion Immunization Manager Vaccine coordinator Vaccine coordinator back-up
Have a copy of the most recent provider agreement
Check if the above listed staff have changed since the provider agreement was completed
Check all of the vaccines administered at your site and list the corresponding publication date for each VIS you give to patients
DTaP _____________ Hepatitis A _____________ Hepatitis B _____________ Hib _____________ HPV _____________
Influenza _____________ MCV4 _____________ MMR _____________ MMR-V _____________ PCV13 _____________
Polio _____________ Rotavirus _____________ Tdap _____________ Varicella _____________
Non-Routine Vaccines Men B__________ PPSV23 _____________ Td _____________
Vaccine administration fee charged for MnVFC eligible children is $
Have a Vaccine Management and Emergency Plan that has been reviewed and dated within the last year
Have the borrowing reports if applicable for the last 12 months available at the visit
Have an anaphylaxis protocol that is clearly posted and reviewed annually
Send an appointment reminder email and the MnVFC Pre-Visit Worksheet to the MnVFC contact A sample letter and the MnVFC Pre-Visit Worksheet can be found on the IPI Advisor Site Visit Materials (wwwhealthstate mnusdivsidepcimmunizeipisvmaterialshtml) page You can request that the MnVFC Pre-Visit Worksheet and temperature logs be sent to you prior to the visit for your review
Contact the site by phone or email one or two working days before the scheduled visit to confirm your appointment This is also a good time to ask for directions and parking information if you are not familiar with the site
Preparing for the Visit Review the site visit paperwork to familiarize yourself with the questions For most of the questions there is a ldquoNote to the reviewerrdquo These notes give helpful tips about the information you are looking for when asking this question It contains the rationale for the question and which resources to provide to the site to support the rationale Some sections also require immediate on-site actionsmdashthings you must do while you are at the site and some require future follow up
bull Print copies the of site visit paperwork bull Site visit forms are available on the IPI Advisor Site Visit Materials (wwwhealthstatemnusdivs idepcimmunizeipisvmaterialshtml) page 2017 MnVFC Site Visit Questionnaire 2017 MnVFC Site Visit Storage amp Handling per Unit Answer Sheet (print one for each stand-alone andor combination storage unit at the site) 2017 MnVFC Provider Follow-up Plan (print two copies)
bull Review any previous site visit paperwork that is available You should check in with MDH staff after your visits if the site continues to have the same issues as past visits
bull Also be sure to bring Your thermometers If the sitersquos certificate of calibration is expired or the probe is not properly placed place your thermometer in the storage unit when you arrive and read the temperature just prior to reviewing the site visit findings
The MnVFC folder with additional immunization resources you wish to add (see chapter 5) and the Vaccine Storage amp Handling magnet (to order email healthIPIinquiriesstatemnus) A copy of the appropriate MnVFC Policies and Procedures Manual found on the MnVFC website (wwwhealthstatemnusvfc) Appropriate temperature logs (Celsius or Fahrenheit) Site information sheet that contains the quantity and value of the vaccine distributed to the sitesystem
Page 12 IPI Advisor Manual | February 2017
Site Visits Chapter 3
Conducting the Visit Education is a large part of the MnVFC site visit Often approaching this visit as an exchange of information with the site is more successful than a ldquoregulatoryrdquo visit Putting the staff at ease answering their questions and making a plan to address issues that arise during the visit is more helpful than a ldquopassfailrdquo attitude Education will usually consist of providing the rationale for the requirement referring to the requirement in the MnVFC Policies and Procedures Manual and providing resources to help address the situation Some questions will require additional follow-up to assure the site has corrected the issue(s) and is meeting the MnVFC requirement(s) This will be addressed further in the follow-up section
Completing the Paperwork
There are three documents that you must complete for the MnVFC site visit bull 2017 MnVFC Site Visit Questionnaire bull 2017 MnVFC Site Visit Storage amp Handling per Unit Answer Sheet (one for each storage unit) bull 2017 MnVFC Provider Follow-up Plan (two copies or you may ask them to make you a copy of the completed form for their records)
Answer the questions on the MnVFC Site Visit Questionnaire based on how things are when you arrive at the site If they correct the issue during the visit you will still mark it as an unmet requirement and document how it was addressed during the visit
The ldquoAnswerrdquo field will contain all the possible answer choices for this question For most questions answer choices will be followed by the markings below
bull Answer choices with no marking mean the site meets the CDC requirement bull Answer choices marked with an [X] indicate that this specific answer choice is non-compliant with a CDC requirement
bull Answer choices marked with an [O] indicate that this specific answer choice is not aligned with a CDC recommendation
If you marked the box with the [X] which is non-compliant with the CDC requirement conduct a root cause analysis to determine the reason for non-compliance Root cause analysis is an important component to a successful site visit It is used to identify the cause of the problem and help to resolve the issue There are several possible root causes that can be identified Choose only one root cause
bull Human cause Personal beliefsopinions Does not understand rationale of requirement Lack of concern for compliance
bull Organizational cause Competing job assignmentsworkload Lack of (insufficient) staff to perform required duties Budget limitations (for required equipment) Lack of (insufficient) training of staff Lack of (insufficient) processesprotocols
IPI Advisor Manual | February 2017 Page 13
Site Visits Chapter 3
Once identified the root cause should be documented in the questionnaire including a brief explanation of why you chose that cause This allows for follow-up with the site and a way to help find improvements to meet the unmet requirement Complete any immediate on-site action These often require providing education and resources for the site Mark the box for each action taken If you provide additional resources or information you can use the notes section to indicate the additional items
ldquoFuture follow-uprdquo are actions the site needs to take to meet the requirements of the program Wersquoll go over more specific information about the site visit questionnaire in Chapter 4
Performing the Site Visit
As you become familiar with the MnVFC program and develop a relationship with your sites you will develop a visit pattern that works for you Here is one possible sequence for conducting MnVFC site visits
bull When you arrive at the site if you have a business card it is helpful to provide it to the front desk staff person
bull When you meet with the immunization manager andor vaccine coordinator introduce yourself and explain the expectations for the visit
bull Ask to see the temperature monitoring device(s) It must have a current certificate of calibration and the probe must be properly placed in the unit If it does not meet the requirements place your thermometer in the unit at the beginning of the visit so that it has sufficient time to reach an accurate temperature by the time you complete your assessment of the storage units
bull 2017 MnVFC Site Visit Questionnaire Ask all of the questions You may have to modify the order of the questions based on what is best for the site When you get to the storage and handling section (section 4) use the answer sheet(s) to document the answers to the questions for each storage unit that stores vaccine (MnVFC or private) Do not write answers in the questionnaire unless there is an unmet requirement Be sure to ask if there is vaccine stored anywhere else at any time at this location This includes a co-located pharmacy If so these additional units will need to be assessed as well If the site has a combination refrigeratorfreezer household unit and is using both sections discuss with them the recommendation (and probable future requirement) to have a separate freezer Refer to MDH if they have further questions or need more information Be prepared to address any storage and handling mishaps that you may find A copy of the
Clinicianrsquos Vaccine Mishap Checklist is with your visit materials and the Emergency Response Worksheet is in the MnVFC Policy and Procedure Manual If you are unsure how to handle the problem call the MnVFC program at 651-201-5522 during or after the visit
Page 14 IPI Advisor Manual | February 2017
Site Visits Chapter 3
Ending the Visit bull Fill out the two copies of the 2017 MnVFC Provider Follow-up Plan (or ask them to make a copy once it is completed for their records) Indicate if they have not met the requirement by checking the box in the ldquoUnmetrdquo column If they are not meeting requirements check the required actions Review the plan with them reinforcing the positive things they are doing as well as reviewing the required follow-up action(s) Give the site a copy of the Provider Follow-up Plan Keep the signed copy of the Provider Follow-up Plan to submit with your paperwork Do not leave a copy of the Site Visit Questionnaire at the site
bull Let them know you will be sending a thank you email that will summarize the site visit Included in the email will be a survey link you would appreciate them completing regarding the visit
After the Visit bull Send the site a thank you email There is a template thank you letter on the IPI Advisor Site Visit Materials (wwwhealthstate mnusdivsidepcimmunizeipisvmaterialshtml) page Be sure you include the issues that you identified and the timeline for their completion as well as the good things you found at the visit In the template letter be sure to include the survey link The survey is very brief ndash a few questions and space to write comments
bull Either transfer your MnVFC Site Visit Questionnaire and MnVFC Site Visit Storage amp Handling per Unit Answer Sheet information to the fillable version or submit the handwritten form to MDH
Documentation of the Visit
Paperwork must be submitted to MDH within 10 days of the visit in order to meet the federal VFC programrsquos reporting requirements Do not wait to complete your follow-up before submitting the site visit paperwork
Send the following documents to MDH bull 2017 MnVFC Site Visit Questionnaire (includes the cover sheet) bull 2017 MnVFC Site Visit Storage amp Handling per Unit Answer Sheet (one for each unit) bull 2017 MnVFC Provider Follow-up Plan (original signed plan)
Submit site visit materials to bull Email healthIPIinquiriesstatemnus (preferred) bull Mail IPI Program Specialist
Immunization Practices Improvement Program Minnesota Department of HealthPO Box 64975St Paul MN 55164-0975
IPI Advisor Manual | February 2017 Page 15
Site Visits Chapter 3
Future follow-up Follow-up is an important component of the site visit It helps us ensure that the unmet requirements have been corrected The questionnaire has different time periods for follow-up depending on the question Do not wait to complete your follow-up before submitting the site visit paperwork
When you complete the Follow-Up Form make sure to keep a copy for yourself MDH also keeps track of follow-up required and will remind you if follow-up has not been completed by the deadline Most follow-up can be done with a phone call or email In-person follow-up is rarely required and should be discussed with MDH before scheduling a follow-up visit
All requirements that need follow-up are identified with a [X] on the site visit paperwork and are listed on the MnVFC Provider Follow-up Plan
bull Follow-up with the site to see how they have resolved the unmet requirements bull Document your follow-up on the Follow-Up Form available on the IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml) page If follow-up was done via letter or email a copy can be attached to the Follow-Up Form
bull Send your Follow-Up Form to MDH (healthIPIinquiriesstatemnus) with supporting documents and emails
bull If a site is not responding to your requests regarding follow-up contact your MnVFC clinical coordinatorplanner They can help with additional follow-up as needed
Page 16 IPI Advisor Manual | February 2017
Chapter 4 The 2017 MnVFC Site Visit Paperwork This chapter will go through the required MnVFC site visit paperwork with notes about information or resources to help the site address questions or issues that may arise during the visit
The MnVFC site visit paperwork is available on the IPI Advisor Site Visit Materials (wwwhealthstate mnusdivsidepcimmunizeipisvmaterialshtml) page
Please download the paperwork shortly before your visit as there may be updates and changes and this will be the most up-to-date version of the questionnaire We will send out a Workspace message with major changes
Required Paperwork for Site Visits bull 2017 MnVFC Site Visit Questionnaire bull 2017 MnVFC Storage amp Handling Per Unit Answer Sheet ndash one for each unit assessed during site
visit bull 2017 MnVFC Provider Follow-up Plan ndash with provider signature
Make sure to include the sitersquos PIN on all your paperwork Please complete and submit your site visit paperwork as soon as possible after your visit It may be helpful to schedule some time into your calendar to complete your paperwork in the days following your visit Once you have completed the post-visit follow-up send in the Follow-Up Form with documentation of the follow-up actions Please do not wait until you have completed your follow-up before sending in your initial paperwork
MnVFC Site Visit Questionnaire The questionnaire includes these six sections 1 Provider details 2 Eligibility 3 Documentation 4 Storage amp handling per unit 5 Storage amp handling site-wide 6 Inventory
IPI Advisor Manual | February 2017 Page 17
Page 18 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
The Site Visit Reviewer Legend The legend explains the formatting of the 2017 questionnaire This includes information that will be helpful in completing the site visit
Site Visit Reviewer Guide Legend
Section Number Content Area
Question number This area will always contain the text of the question
Note to reviewer The note to reviewer contains information that is necessary for properly asking and assessing responses tothe question above This may include definitions of terms requirement details and other helpful tips
Answers This field will contain all the possible answer choices for this question For most questions answer choiceswill be followed by the markings below
Answer choices marked with an [X] indicate that this specific answer choice is non-compliant with a CDC requirement Answer choices marked with an [O] indicate that this specific answer choice is not aligned with a CDC
recommendation
Review CDC RequirementRecommendation
This field will be populated with the CDC requirementrecommendation associated with the given question
Actions if Non-Compliant
Root Cause Analysis As part of the site visit reviewers are required to assess and understand the reasons why a provider office isnon-compliant with VFC program requirements ndash this is a root cause analysis Reviewers must choose theone root cause that they believe most contributes to the non-compliance Upon establishing the root causethe reviewer must provide a clear explanation of hisher findings
Immediate Action These are actions that CDC requires reviewers to take on site during the visit
Future Follow-up These are future follow-up actions (with designated due dates) that are required of the reviewer andorprovider to remedy non-compliance Reviewers must complete all follow-up in accordance with CDCestablished deadlines
Notes Information you want the VFC program to be aware of or that explains your answer in detail
bull Note to reviewer These are notes to help you understand what the question is asking for and to clarify things you might want to know when asking or rephrasing the question
bull Answers This section helps you to know when the answer does not meet the CDC requirement [X] or recommendation [O] Whenever an answer with a [X] is checked the ldquoActions if Non-compliant section must be completed The recommendations are usually good teaching points about best practices andor future requirements of the VFC program
bull Review the CDC RequirementRecommendation This section provides a specific outline of the requirement or recommendation to give you information to use in talking with the site staff
bull Actions if Non-Compliant This section describes what to do if the site is not meeting a requirement Root cause analysis This section asks you to probe beyond the surface to find what is driving the non-compliance It is intended to help uncover reasons for recurring non-compliance issues identify additional training needs and inform reviewer follow-up actions Select only one root cause and explain the particular circumstances in the space ldquoExplanation of root causerdquo line provided If there appear to be multiple issues choose the one that most contributes to the non-compliance and describe all factors in the explanation Immediate actions A list of actions to take during the site visit to address the issue Future follow-up A list of actions to take after the site visit by the set deadline
bull Notes This section can be used for notes to yourself or to MDH
IPI Advisor Manual | February 2017 Page 19
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 1 Provider Details Questionnaire Coversheet
The first page of the questionnaire collects the demographic information for the site You can use this page to help prepare for the visit Most of the demographic information about the site should be on the site-specific document you received with your clinic list You will validate that this information is current at the time of the site visit It also helps to know if this is a separate stock site or a replacement site before the visit so you can bring a copy of the appropriate MnVFC Policies and Procedure Manual
2017 MnVFC Site Visit Questionnaire Date of visit _____________ Date forms sent to MDH ______________
Site Information
Site name MnVFC PIN
Address Separate Stock Replacement
City ZIP County
Medical Director Email
Immunization Manager Phone
Vaccine Coordinator Phone
Vaccine Coordinator back-up Email
Point of contact Phone
Personnel at site visit
On this page bull The date of the visit and the date when you send these forms to MDH This information helps us track the timeliness of our review and data entry process
bull The vaccine management method used by the site (replacement or separate stock) bull The name and email of the medical director (ideally this is the person who signed the MnVFC
Program Provider Agreement)bull Contact information for the immunization manager vaccine coordinator vaccine coordinator back-up and point-of-contact for this visit The immunization manager vaccine coordinator vaccine coordinator back-up roles are
described in the MnVFC Policies and Procedure Manual The vaccine coordinator back-up may be the immunization manager or another staff person depending on the size of the site and available personnel The Point of Contact is the person you set up the appointment with signs the Provider Follow-
up Plan and receives the follow-up email This may be one of the people listed above
The Post Visit Steps section is a reminder to you about what needs to done after the visit The Education on Immunization Best Practices for Sites section reminds you to provide the resource folder to the site
Page 20 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 12
1 Provider Details Changes to Key Staff
Question 12 Ask the provider about changes to key staff to answer the questions below
A (Choose all that
apply)
At the time of the visit is the Medical Director the same individual that signed the ProviderAgreement and are the Immunization Manager and Vaccine Coordinator the same asthose last reported to the program
Yes No the Medical Director has changed No the Immunization Manager has changed No the Vaccine Coordinator has changed
B (Choose one)
Were all changes communicated to theImmunization Program according to yourprogramrsquos policy
Yes or no staff changes No [X]
C (Choose one)
Based on review of the trainingdocumentation have the current Immunization Manager Vaccine Coordinator and back-up completed all required training
Yes No [X]
Review CDC Requirement
All changes in key staff must be communicated to the Immunization Program in the manner and timeframe defined by theImmunization Program Key staff include the Medical Director or equivalent who signed the Provider Agreement the Immunization Manager Vaccine Coordinator and the back-up VFC providers are required to ensure that all key staff are fully trained on VFC program requirements at all times All training must be documented
Goal of this question Determine if there are new staff in key positions at the site and to make sure staff are properly educated about the MnVFC program A This information can help you determine the level of knowledge and experience the staff have with the MnVFC program Follow-up throughout the visit can be tailored for various levels of staff experience Likewise you may identify additional training needs for new staff
B When sites notify us of changes in key personnel we update their information in MIIC and on the clinic lists We also send the new staff information for completing the online training and direct them to read the appropriate MnVFC Policies and Procedures Manual If the answer to this part is no update the demographic area of the questionnaire and inform the staff that in the future they must notify the MnVFC program (via email or phone) if the immunization manager or vaccine coordinator changes Resource Section 12 of the MnVFC Policies and Procedures Manual
C Annual training must be verified by looking at the certificates for the online training If the answer to this part is no refer the staff to complete the appropriate MnVFC online training found on the MnVFC website (wwwhealthstatemnusvfc) for their program (separate stockreplacement) for the current year and send you a copy of the certificate within 30 days
Resource bull Sections 12 and 14 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 21
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 2 Eligibility Question 21
Goal of this Question Assess whether staff correctly understand which patients are eligible for the MnVFC program Screening ensures that eligible children receive the vaccines that they are entitled to receive under the MnVFC program and helps to prevent fraud or abuse of the program
Children 18 years and younger in these
categories can receive MnVFC vaccine at any enrolled site bull Uninsured bull Enrolled in a Minnesota Health Care Program (MHCP) Medical Assistance (MA) or MinnesotaCare bull American Indian or Alaskan Native
The following categories are considered underinsured and are only MnVFC-eligible at local public health (LPH) Federally Qualified Health Centers (FQHC) Rural Health Centers (RHC) Indian Health Services (IHS) and tribal health clinics
bull Has health insurance that does not cover one or more vaccines as can be the case with newly licensed vaccines that arenrsquot yet covered (MnVFC-eligible for non-covered vaccines only)
bull Has health insurance that caps vaccine coverage at a certain amount Once that amount is reached the child is MnVFC-eligible
Children with insurance that does not cover vaccines until a deductible has been met are considered to be fully insured and are not MnVFC-eligible
Helpful information bull Sites are not required to verify the patientrsquos response to the screening questions For example if a patient states they lost their insurance the site does not need to call the patientrsquos insurance company to confirm
If the site cannot correctly describe the eligibility categories provide educational materialsresources on MnVFC eligibility requirements
Resources bull Patient Eligibility Screening Record on MnVFC Forms (wwwhealthstatemnusdivsidepc immunizemnvfcformshtml)
bull Section 1 of the MnVFC Policies and Procedures Manual
2 Eligibility VFC Eligibility Categories
Question 21 Was the individual responsible for determining patient VFC eligibility able to explain all the factors(including age) that make a child eligible to receive VFC vaccines
A Patient is less than 19 years of age Yes No [X]
B Patient is Medicaid-eligible Yes No [X]
C Patient is uninsured Yes No [X]
D Patient is underinsured Yes No [X]
E Patient is American Indian Yes No [X]
F Patient is Alaska Native Yes No [X]
Review CDC Requirement
VFC providers must possess a working knowledge of all VFC eligibility criteria and use those criteria to screen children prior toadministering VFC vaccines In order to receive VFC vaccine a patient must be under the age of 19 and must be at least one of the following (1) Medicaid-eligible (2) Uninsured (ie child has no health insurance) (3) Underinsured (ie child has health insurancebut coverage does not cover any or certain vaccines ndash underinsured children may only receive VFC vaccines in FQHCRHC ordeputized VFC provider offices and only for vaccines not covered by insurance) and (4) American Indian or Alaska Native (AIAN)
Page 22 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 22
2 Eligibility Billing Practices
Question 22 Is the individualdepartment responsible for billing able to clearly explain how they bill for both the costof vaccine and the vaccine administration fee for each of the eligibility categories below
A Medicaid-eligible Cost of Vaccine Do not bill ndash provided by VFC Admin Fee Bill Medicaid
Yes No [X]
B Uninsured Cost of Vaccine Do not bill ndash provided by VFC Admin Fee If billing can bill patient
Yes No [X]
C Underinsured Cost of Vaccine Do not bill ndash provided by VFC through FQHCsRHCs or deputized providers only all other providers cannotprovide VFC vaccine to underinsured patients Admin Fee If billing can bill patient
Yes No [X]
D American IndianAlaska Native(AIAN)
Cost of Vaccine Do not bill - provided by VFC unless patient is fully insured and parent chooses to use insurance Admin Fee If patient is Medicaid-eligible bill Medicaid if billingand patient is uninsuredunderinsured can bill patient if parentchooses to use private insurance for cost of vaccine billpatientinsurance
Yes No [X]
E Do individuals responsible for billing have access to the results of eligibility screening toensure proper billing
Yes No [X]
Review CDC Requirement
VFC providers must adhere to proper billing practices for vaccine administration fees and clearly understand that VFC vaccine isprovided at no cost to both the VFC provider and eligible children At no time should billing occur for the cost of VFC vaccine Whenadministering VFC vaccine providers should never bill two different ldquopayersrdquo (ie patient Medicaid insurance) for the samevaccine administration fee amount For Medicaid-eligible children Medicaid should be billed for the vaccine administration fee Forall other VFC-eligible populations the patient may be billed within the stateterritory cap established by the Centers for Medicareand Medicaid (CMS) However patients cannot be turned away or reported to collections for inability to pay the administration fee
Goal of this question Determine if the staff correctly understand how to bill patients that are eligible for the MnVFC program Billing appropriately ensures that children can receive low cost immunizations and the site is in compliance with the VFC program
bull If there is any indication that sites could be billing insurance companies or parents for VFC vaccines this should be investigated further
bull Most sites in Minnesota will bill Medicaid with the SL modifier ndash which indicates this is a Medicaid claim
bull The main point is to ensure the site is not billing uninsured children for VFC vaccine and are not charging them more than $2122 per vaccine for the administration fee
bull Non-compliance is usually unintentional and may be resolved with some training In rare cases it could be a glimpse into a larger problem where a site is intentionally billing for financial gain
bull If you think the site is billing inappropriately it is the responsibility of the IPI advisor to report concerns to MDH staff for further assistance
Resources bull Immunization Billing Guidance for MnVFC (wwwhealthstatemnusdivsidepcimmunizemnvfc billingtipshtml) or Immunization Billing Guidance for MnVFC Replacement Method Sites (www healthstatemnusdivsidepcimmunizemnvfcreplacementbillingtipsrephtml)
bull Section 2 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 23
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 232 Eligibility Vaccine Administration Fee
Question 23 Document the actual vaccine administration fee charged to non-Medicaid VFC-eligible patients (confirmwith billing department)
Answers Fee $ [X] Follow-up is required if the provider charges more than the fee cap establishedby the Centers for Medicare and Medicaid (CMS) for your stateterritory ($2122)
Review CDC Requirement
The VFC providerrsquos vaccine administration fee for non-Medicaid VFC-eligible children must not exceed the stateterritory vaccineadministration fee cap established by the Centers for Medicare and Medicaid (CMS) For current fee caps refer to Medicaid Program Payments for Services Furnished by Certain Primary Care Physicians and Charges for Vaccine Administration Under theVaccines for Children Program Final Rule (httpwwwgpogovfdsyspkgFR-2012-11-06pdf2012-26507pdf)
Goal of this question Ensure that sites are not charging more than the federal allowable vaccine administration fee of $2122
bull The Centers for Medicaid and Medicare (CMS) establishes a maximum fee that sites can charge to non-Medicaid-eligible VFC patients in each stateterritory for vaccine administration Health Plans usually negotiate this fee with the site but Medicaid will not pay more
bull If a parent cannot pay the vaccine administration fee the patient cannot be turned away or reported to collections VFC-eligible children must be vaccinated regardless of their ability to pay
bull If the person with whom you are conducting the site visit does not know the exact fee charged to non-Medicaid VFC-eligible patients ask to speak to someone who can verify the exact amount
bull If they are charging more than $2122 for the administration fee ndash please contact MDH staff for help with addressing this situation
Resources bull Immunization Billing Guidance for MnVFC (wwwhealthstatemnusdivsidepcimmunizemnvfc billingtipshtml) or Immunization Billing Guidance for MnVFC Replacement Method Sites (www healthstatemnusdivsidepcimmunizemnvfcreplacementbillingtipsrephtml)
bull Section 2 of the MnVFC Policies and Procedures Manual
Page 24 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 3 Documentation Question 31
3 Documentation Eligibility Screening amp Documentation
Question 31 To answer the questions below the provider must clearly demonstrate the patient intake processReview a minimum of 10 records that contain an immunization visit within the last 6 ndash 12 months
Note to Reviewer Criteria for Record Selection 1) Record selection must be completely random and the provider must not know prior to the visit which
records will be reviewed 2) Patient must have been 0-19 years of age at the last visit (Note Records of 19-year-old patients may
allow you to see if VFC vaccines are being used beyond the allowable age) 3) Must review a mix of public and private-pay patients (if applicable)
A Does the provider have a process that ensures that patients are screened forVFC eligibility at each visit and that screening results are documented at each visit
Yes No [X] (If no skip question F)
B Does the providerrsquos process ensure that staff administering vaccine know which vaccine stock to select from prior to drawing the vaccine
Yes No [X]
C Number of records reviewed If fewer than 10 records are reviewed select the reason why Provider does not have 10 patient records with immunizations in last 12 months
D Do all records contain date of the immunization visit and patientrsquos date of birth Yes No [X]
E Do all records contain the patientrsquos specific eligibility status associated with thedate of the immunization
Yes No [X]
F Do any of the providerrsquos records contain any evidence that the patient received vaccine for which they were not eligible
Yes [X] No
Review CDC Requirement
VFC providers must screen for and document VFC eligibility at each immunization visit Documentation must include the date of the visit and the childrsquos specific eligibility category VFC providers must use screening results to ensure that only VFC-eligible children receive VFC vaccine and that administration fees are billed for as appropriate Eligibility status must be readily available to staff administering vaccine prior to selecting which vaccine stock to use
Goal of this question Ensure the site is screening for eligibility and documenting the eligibility category in the medical record
Review a minimum of 10 records from within the last 6-12 months where the patient received an immunization You must review a mix of public and private pay patients (if applicable)
Random selection is important If the staff have pre-selected records for review do not use and identify additional randomly selected records to review
Helpful information bull Discuss upgrading the electronic health record to make documentation of VFC eligibility screening a required field Documenting eligibility screening in the immunization field promotes better MIIC data
bull Q 31 B Sites using the replacement method of vaccine management only have one stock so you will answer ldquoYesrdquo to this question
Resources bull Patient Eligibility Screening Record on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfcformshtml)
bull Section 1 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 25
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 32
3 Documentation Vaccine Dose Documentation
Question 32 Review a minimum of 10 patient immunization records from the last six months (or 12 months ifnecessary) to assess compliance with documentation requirements set forth by Statute 42 US Code 300aa-25 (See note to reviewer below)
Note to Reviewer Criteria for Record Selection 1) Record selection must be completely random the Provider must not know prior to the visit which records
will be reviewed 2) Patient must have been 0-19 years of age at the last visit (Note Records of 19-year-old patients may allow
you to see if VFC vaccines are being used beyond the allowable age)
Records are Compliant if they Contain ALL the Below Elements
bull Address of clinic where vaccine was administered bull Publication date of VIS bull Name of vaccine administered bull Name of vaccine manufacturer bull Date vaccine was administered bull Lot number bull Date VIS was given bull Name and title of person who administered the
vaccine
A Number of records reviewed
B Number of records that contain ALL required documentation elements
If fewer than 10 records are reviewed select the reason why Provider does not have 10 patient records with immunizations in last 12 months
[X] Follow-up isrequired if one ormore records do not meet requirements
Goal of this question Assess whether the site is documenting all required information in each patientrsquos medical record for every vaccine dose administered in accordance with the National Childhood Vaccine Injury Act
Resources bull Section 6 of the MnVFC Policies and Procedures Manual bull National Vaccine Injury Compensation Program (wwwhrsagovvaccinecompensation)
Question 33
3 Documentation Record Retention
Question 33 Is the provider able to demonstrate (preferred) or clearly describe how they maintain historical VFCeligibility documentation for three years
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers are required to maintain all records related to the VFC program for a minimum of three years (or longer if requiredby state law) and upon request make these records available for review VFC records include but are not limited to VFC screening and eligibility documentation billing records medical records that verify receipt of vaccine vaccine ordering records and vaccinepurchase and accountability records
Goal of this question Make sure the site understands they are required to keep all MnVFC screening documentation for at least three years either electronically or on paper This information should be available to you at the time of the visit and future visits
Resource bull Section 7 of the MnVFC Policies and Procedures Manual
Page 26 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 34
3 Documentation Borrowing Documentation
Question 34 Discuss borrowing practices with the provider to answer the questions below
Note to Reviewer bull To be considered ldquofully documentedrdquo documentation for each borrowed dose must include thefollowing information
Vaccine type borrowed Date the dose was administered Stock used (VFC or private) Reason appropriate vaccine stock was not used Patient name and date of birth Date dose was returned to appropriate stock
A Did the provider state that they had borrowed any vaccines (whetherdocumented or not) since the last VFC Compliance Site Visit
Yes No (If no skip to question 36)
B Are there any doses for which there is no documentation (ie provider hasindicated that doses were borrowed but cannot verify how many or why)
All doses are documented Some doses are not documented [X] No doses are documented [X] (if nodoses documented skip toquestion 36)
C Were all borrowed doses fully documented (See Note to Reviewer above) Yes No [X]
D Were all borrowed VFC doses either replaced or an order submitted to replacethe doses Yes No [X]
Review CDC Requirement
VFC providers are expected to maintain an adequate inventory of vaccine for VFC and non-VFC-eligible patients It is theresponsibility of the VFC provider to appropriately schedule and place vaccine orders VFC providers must also rotate stock to ensure timely use of short-dated vaccines Borrowing of vaccine between private and public inventories must be a rare unplanned occurrence and cannot serve as a replacement system for a VFC providerrsquos privately purchased vaccine inventory All instances ofborrowing must be properly documented reported and replaced
Goal of this question Assess vaccine accountability by verifying that children are receiving vaccine from the appropriate stock
Borrowing is when a fully insured child receives a dose of MnVFC vaccine or a MnVFC-eligible child receives a dose of private vaccine This should be a rare unplanned occurrence The site must document any borrowing of vaccine between stocks ideally on the VFC Borrowing Report Form If they are not currently using the form review it with them and encourage them to post it close to their vaccines It does not need to be sent to MDH but should be kept for 3 years and filed with their MnVFC documents to be reviewed whenever they have a regular or unscheduled (unannounced) site visit
Helpful information bull Understand and report on staffrsquos verbal (ie anecdotal) accounts of borrowing obtained during the visit Often sites do not know that what they do is considered borrowing or they think borrowing is acceptable and documentation isnrsquot needed so long as those vaccines are eventually replaced
bull Since sites using the replacement method only have one stock of vaccine they very rarely borrow bull This question asks for future follow-up in 6 months Make a note on your calendar and ask them to send you a copy of their borrowing reports for the previous 6 months with documentation of doses borrowed and replaced We will remind you if we donrsquot hear from you at the 6 month time frame Complete the Follow-up Form and attach the borrowing form
Resources bull Vaccine Borrowing Report on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfc formshtml)
bull Section 10 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 27
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 353 Documentation Borrowing Reasons
Question 35 Based on your discussion with the provider and a review of borrowing reports document the dosesborrowed for each reason and answer the questions below
Note to Reviewer bull Short-dated vaccines are doses that are likely to expire before they can be used bull Exchanging short-dated vaccines should only occur in practices that have a small number of private
patients
A Reasons for Borrowing a VFC Dose (Enter the number of _____ Private vaccine shipment delay (order placed on time but delay in shippingreceipt)
vaccine doses borrowed for each
reason in the spaces
_____ Private vaccine not useable on arrival (vials broken temperature monitor out of range) _____ Ran out of private vaccine between orders (provider orders not placed on time) [X]
provided) _____ Short-dated private dose was exchanged with VFC stock _____ Accidental use of VFC dose for a private patient (human error) _____ Replacement of private dose with VFC when insurance plan did not cover vaccine _____ OtherDocumented dose did not include reason for borrowing [X]
(Explanation Required) Reasons for Borrowing a Private Dose _____ VFC vaccine shipment delay (order placed on time but delay in shippingreceipt) _____ VFC vaccine not useable on arrival (vials broken temperature monitor out of range) _____ Ran out of VFC stock between orders (provider orders not placed on time) [X] _____ Short-dated VFC vaccine dose was exchanged with private dose _____ Accidental use of a private dose for a VFC-eligible patient (human error) _____ OtherDocumented dose did not include reason for borrowing [X]
(Explanation Required)
B Enter date range for instances of borrowing reviewed in the borrowing report Note If ldquoDate of earliest instancerdquo is not available use the date of the last VFC Compliance Visit If ldquoDate of last instancerdquo is not available use the date of thecurrent VFC Compliance Visit
Date of earliest instance
Date of last instance
C Does borrowing appear to be a routine practice Note To determine whether borrowing is a routine practice assess frequency of and repeating reasons for borrowing Examples Frequent accidental use of incorrect stock exchanging short-dated vaccines or issues with ordering and shipment
Yes [X] No
Goal of this question Determine the reasons why the site is borrowing vaccine
If sites are using the Vaccine Borrowing Report review the reasons for borrowing to help document borrowed VFC andor private doses If they have not been documenting borrowing on this report (or any other form) estimate their borrowing practices If you do not know the date range for their borrowing use the last site visit date to the current visit date The use of ldquootherrdquo as the reported reason for borrowing should be rare if ever and would require explanation and follow up
Helpful information bull Look to see if they routinely maintain insufficient amounts or types of vaccine to support their public and private patients that leads to borrowing
bull Pay attention to borrowing cases documented as ldquoaccidentalrdquo Repetitive accidental borrowing may indicate an issue with ordering processes or insufficient staff training
bull Borrowing is not a place to document wasted or lost doses bull The time period of the borrowing may give you clues about the root cause Were the borrowed doses concentrated in a short period or spread out across several months or a year Are all vaccine types being borrowed or just one
bull If borrowing seems to be an issue discuss vaccine management ordering procedures
Resources bull Vaccine Borrowing Report on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfc formshtml)
bull Section 10 in the MnVFC Policies and Procedures Manual
Page 28 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 36
3 Documentation Vaccine Management Plan
Question 36 Physically review the providerrsquos Vaccine Management Plan to answer the question below
A Does the provider have a Vaccine Management Plan Yes No [X] (If no skip to question 37)
B Does the plan list the current Immunization Manager Vaccine Coordinator andback-up
Yes No [X]
C Does the plan address proper vaccine storage and handling practices Yes No [X]
D Does the plan specify vaccine receiving procedures Yes No [X]
E Does the plan contain procedures for what to do with vaccine in the event of an emergency
Yes No [X]
F Does the plan contain procedures for vaccine ordering Yes No [X]
G Does the plan address inventory control (example stock rotation) Yes No [X]
H Does the plan address how to handle vaccine wastage Yes No [X]
I Does the plan address staff training and documentation on vaccine managementstorage amp handling
Yes No [X]
J Does the plan contain a review date that falls within the last 12 months Yes No [X]
K Has the plan been signed by the individual responsible for its content Yes No [X]
Review CDC Requirement
VFC providers must develop maintain and implement a Vaccine Management Plan for routine and emergency vaccinemanagement The plan must contain the current Vaccine Coordinator and back-up proper storage and handling practicesshipping and receiving procedures emergency procedures procedures for vaccine ordering inventory control (eg stock rotation)how to handle vaccine wastage and staff trainingdocumentation on vaccine management storage and handling The plan must bereviewedupdated annually or more frequently if changes occur A ldquoreview daterdquo and signature are required on all plans in order tovalidate that they are current
Goal of this question Evaluate the sitersquos plan for vaccine management It is especially important that they have a plan for emergency management of their vaccine in the case of equipment failure or power outage Encourage all sites to read and sign the MnVFC Policies and Procedures Manual and complete the emergency plan or be able to show you a plan of their own
If the provider is not able to physically show you the plan at the time of the visit or if the recorded review date is not within the last 12 months you must mark that this requirement is unmet The Vaccine Management Plan is important in times of emergency and it should be easy to access by any staff member at any time Encourage them to post the plan and put a copy with the packing supplies
Helpful information bull Encourage the site to fill in the ldquoImmunization Managerrdquo and ldquoVaccine Coordinatorrdquo fields in the
MnVFC Policies and Procedures Manual for their own referencebull The emergency plan in the manual can be reviewed from last year and included in this yearrsquos manual (with an updated signature and date) if there have not been any changes
bull If information in the plan is outdated site staff will not be well equipped to safely manage vaccines in the event of a power-outage or other emergency situation
bull If their institutional policy is only reviewed and updated every 3-4 years (as many are) the staff may need to sign the MnVFC Polices and Procedure Manual to meet this requirement
Resource Routine Vaccine Management Plan and Emergency Vaccine Management Plan in the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 29
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 37
3 Documentation VIS amp VAERS
Question 37 Review the providerrsquos Vaccine Information Statements (VISs) and discuss providerrsquos VAERS process toanswer the questions below
A Does the provider have readily available up-to-date VISs for all ACIP-recommendedvaccines relevant to the populations it serves
Yes No [X]
B Does the provider make a VIS available for patientsparents before eachvaccination
Yes No [X]
C Does the provider know how and when to report clinically significant adverseevents using VAERS
Yes No [X]
Review CDC Requirement
VFC providers are required to distribute the current Vaccine Information Statements (VIS) each time a vaccine is administered and maintain records in accordance with the National Childhood Vaccine Injury Act (NCVIA) which includes reporting clinicallysignificant adverse events to the Vaccine Adverse Event Reporting System (VAERS) For a list of current VISs visit CDCrsquos Vaccine Information Statements (httpwwwcdcgovvaccineshcpvis) website
Gal of this question Ensure the site has the most current VISs and is giving them to each patientparent before administering the vaccine in compliance with the federal law Parents must be educated about the vaccine their child will receive and be aware of possible contraindications and side-effects in order to make well-informed decisions about their childrsquos health
Helpful information bull Ask to see the sitersquos VISs to determine if they have an active protocol for giving VISs to parents Review to make sure they are current Ask if they know where and how to report vaccine adverse events
Resources bull Section 3 in the MnVFC Policies and Procedures Manual bull CDC Vaccine Information Statements (wwwcdcgovvaccineshcpvisindexhtml) Site may sign up for email updates for the current list of VIS publication dates for the most up-to-date version
bull IAC Itrsquos Federal Law You must give your patients current Vaccine Information Statements (wwwimmunizeorgcatgdp2027pdf)
bull VAERS (httpsvaershhsgovindex)
Question 38
3 Documentation Anaphylaxis protocol
Question 38 Does the site have an anaphylaxis protocol which is clearly posted near the emergency kit
Answers (Choose one)
Yes No [X]
Review CDC Requirement
An anaphylaxis protocol must be clearly posted in the area where vaccines are administered
Goal of this question Make sure site is prepared for a severe allergic or anaphylactic reaction to a vaccine
Resources bull Section 11 in the MnVFC Policies and Procedures Manual bull IAC protocols Child and Teens (wwwimmunizeorgcatgdp3082apdf) and Adults (wwwimmunize orgcatgdp3082pdf)
Page 30 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
i
i i i - li i i i i i l
Section 4 Storage amp Handling Per Unit The goal of this section is to assess vaccine storage
2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet practices in each unit at the site MnVFC PIN ___________________
The 2017 MnVFC Storage amp Handling Per Unit Answer Sheet is a worksheet to document the answers to the questions in this section for each unit (combination or stand-alone) Fill in the answers to the questions in Section 4 on the answer sheet not in the questionnaire
The answer sheet has an abbreviated form of each question If you need further information on that question refer back to the full questionnaire Also if you find an area where the site is not meeting the requirements you will need to go back to that question on the 2017 MnVFC Site Visit Questionnaire to complete ldquoActions if Non- compliantrdquo section including the root cause analysis and follow-up sections If there is a problem in more than one unit make a note on the questionnaire which unit you are referring to in the Notes section
Important You must fully assess any unit that may be used to store VFC vaccines even if there are no VFC vaccines there on the day of the visit If there are no vaccines and the site is not documenting twice a day temperatures discuss the need to ensure the unit is maintaining stable temperatures by monitoring for one week before placing vaccines in the unit
Quest on number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
for the freezer and e co umn
Temperature Monitoring Dev refr gerator f the un
ce Quest ons Quest ons 4 3 4 7 must be answered separate y t s a combo Be sure to document responses n the appropr at
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
44D Data downloaded and reviewed routinely (eg weekly)
Yes No [O]
Yes No [O]
45A Certificate of Calibration Testing Yes No [X]
Yes No [X]
45B Date of calibration
45C Date certificate expires [X] Follow-up is required if expired [X] Follow-up is required if expired
45D Certificate contains all necessary items
Yes No [X]
Yes No [X]
46 Probe properly placed Yes No [X]
Yes No [X]
47A Two temperature readings per day
Yes No [X]
Yes No [X]
47B Time date and name (or initials) for each reading
Yes No [X]
Yes No [X]
47C Current temperature and minmax temperatures (if
Current ________deg Minimum ________deg Maximum _deg
Current ________deg Minimum ________deg Maximum _deg
Sections 5 and 6 contain questions about storage and handling site wide and inventory It is helpful to keep those questions in mind as you assess the individual storage units Think about dorm-style units expired vaccine vaccine supply room for vaccine stocking all the recommended vaccines and separation of stock if appropriate
NOTE The sections that follow require reviewers to validate responses by looking at vaccine storage units temperaturemonitoring equipment and the vaccine inventory inside a unit bull For section 4 use a separate Storage amp Handling Per Unit Answer Sheet for each unit to document the findings (combination
units using both sections can be documented on the same answer sheet) bull When an unmet requirement is identified return to this questionnaire to complete the ldquoActions if Non-compliantrdquo section for
that question bull After you complete one answer sheet for each unit return to the questionnaire to complete sections 5 and 6 using information
you gathered while assessing the units The questions in sections 5 and 6 (Storage amp Handling Site-Wide and Inventory) are notunit-specific but do require that the response be based on a thorough assessment of all the providersrsquo units
4 Storage amp Handling Per Unit
Description On the Storage amp Handling Per Unit Answer Sheet place a name that will allow you or someone else from your program to easily identify this unit in the event of follow-up We recommend using Brand + Location(example Samsung - Room 123) Save each Storage amp Handling Per Unit Answer Sheet with the Brand + Location in the file name
(example SamsungRoom123doc)
IPI Advisor Manual | February 2017 Page 31
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 41
4 Storage amp Handling Per Unit Storage Unit Build amp Use
Question 41 Below select the build and use of the vaccine storage unit you are assessing
Note to Reviewer Dorm-style units Do not add dorm-style units here Dorm-style units will be addressed in section 5 Units storing only private stock You must review these storage units even if they contain only private stockat the time of the visit because that vaccine could be administered to VFC patients
A What type of unit is this A Stand-alone B Combination
B Select use if stand-alone A Freezer B Refrigerator
Select use if combination A Use both sections to store vaccine B Use freezer section only to store vaccine C Use refrigerator section only to store vaccine
Goal of this question Identify the unit you are evaluating The description asks you to create a unique name for this unit so that you will be able to identify the same unit in future site visits Put this description on the top of the answer sheet (ie make and location)
Helpful information bull A stand-alone unit is either a refrigerator or a freezer It does not have both sections in the unit bull If there is a combination unit note if the site uses both the refrigerator and freezer or only one section of the unit to store vaccines CDC does not recommend the use of either section or the freezer section only of combination household units
bull If your site utilizes the separate stock method of vaccine management you must review storage units even if they contain only private stock at the time of the visit because there is a chance that those vaccines could be administered (borrowed) to VFC-eligible patients
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Question 424 Storage amp Handling Per Unit CDC Recommended Storage Units
Question 42 Below document the grade of the vaccine storage unit you are assessing
Note to Reviewer Pharmaceutical Also called ldquopurpose-builtrdquo these units are designed by the manufacturer specifically tostore vaccines or other biological materials Commercial Although usually intended to store food and beverages commercial units are often larger and more powerful than the household units found in most homes Though these units are intended to meet thehigher demands of larger facilities these units are not specifically built for the storage of biologicalmaterials Household (non-commercialdomestic) These units are usually smaller than commercial units and areintended for use in small offices and in homes ndash typically for food storage However just like commercialunits they are not designed specifically for the storage of biological materials Such units are usually available in common home supply stores
Answers (Choose one)
Select grade A Pharmaceutical B CommercialHousehold
[O] CDC does not recommend the use of both sections or the freezer section only of combination commercialhousehold units
Review CDC Recommendation
CDC recommends the following vaccine storage unit types (in order of preference) pharmaceutical grade stand-alone orcombination units (preferred) householdcommercial stand-alone units householdcommercial combination units using therefrigerator section only
Goal of this question Assess the grade and type of each storage unit bull Pharmaceutical grade units may be stand-alone or combination units that are often metal may have glass in the door for viewing inside often have an external digital temperature display and are manufactured by medical companies
bull Commercial or household units often look like your kitchen appliance have vegetablemeat drawers in the unit and are manufactured by household appliance companies
bull Occasionally you might find a medical grade unit which is usually a commercialhousehold unit with a lock and 3-prong plug These are still considered household units because of their ability to maintain proper temperatures and air flow Studies show that household stand-alone units are better able to maintain consistent temperatures than their combination counterparts Combination household units used to store vaccine in both sections of the unit is no longer recommended and may be prohibited in the future Combination household storage units that are having difficulty maintaining a cold enough freezer temperature and a warm enough refrigerator temperature should be replaced or a separate stand-alone freezer should be purchased
For frozen vaccines the most cost effective solution is for the site to purchase a small stand-alone freezer The site may need time to budget for a stand-alone storage unit
Resources bull Replacing Combination Household Units Tip Sheet on IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml)
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The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 434 Storage amp Handling Per Unit Temperature Monitoring Device in the Unit
Question 43 Determine whether there is a temperature monitoring device in this section of the storage unit andanswer the questions
A Is there a temperature monitoring device in this section of thestorage unit
Yes No [X] (If no skip to question 47)
B Who is responsible for supplying the temperature monitoring device in this section of the storage unit Provider
Review CDC Requirement
Certificates of calibration testing provide confidence that the temperature monitoring device is measuring temperaturesaccurately All units storing VFC vaccines must have a calibrated temperature monitoring device with a current and valid certificateof calibration testing All certificates must contain modeldevice name or number serial number date of calibration testing (report or issue date) and Instrument Passed testingInstrument in Tolerance (Recommended uncertainty = +-05ordm C (+-1ordm F))
Goal of this question Assess whether there is a temperature monitoring device in the unit If the unit is not being monitored at all call MDH at 651-201-5522 for guidance
Helpful information bull This question does not ask whether the temperature monitoring device is working or the characteristics of the device These issues will be addressed later in the questionnaire
bull For part B the provider is always responsible for supplying the temperature monitoring device Even if their thermometer or data logger was originally from MDH it is their responsibility to ensure it is functional and calibrated
Resources bull Section 8 in the MnVFC Policies and Procedures Manual
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-
Question 444 Storage amp Handling Per Unit CDC Recommended Temperature Monitoring Device
Question 44 Assess the temperature monitoring device in this section of the storage unit to answer the questionsbelow
A Is the temperature monitoring device a continuous monitoring and recordingdevice (eg data logger)
Yes No [O] (Skip D)
B Does the temperature monitoring device have a probe in buffered material Yes No [O]
C Does the temperature monitoring device have a digital display that can beeasily read from the outside of this unit
Yes No [O]
D Is data downloaded and reviewed routinely Yes No [O]
Review CDC Recommendation
As of Jan 1 2018 all VFC providers must use continuous temperature monitoring devices (eg data loggers) to monitor vaccinesthat will be administered to VFC-eligible children Routine review and accessibility of temperature data is critical for determining whether vaccine has been properly stored and for assessing usability of vaccine that was involved in a temperature excursion Tomeet VFC Program requirements the device must also be equipped with bull A temperature probe bull An active temperature display that can be easily read from the outside of the unit bull The capacity for continuous monitoring and recording capabilities where the data can be routinely downloaded
The following are additional recommended features for these devices bull Alarm for out-of-range temperatures bull Current minimum and maximum temperatures display bull Low battery indicator bull Accuracy of +- 1degF (05degC) bull Memory storage of at least 4000 readings bull User programmable logging interval (or reading rate) recommended at a maximum time interval of every 30 minutes bull Use of a probe that best reflects the temperature of the vaccine (such as a buffered probe)
Goal of this question Assess the temperature monitoring device in the storage unit Note that these are all recommendations not requirements at this time
This is a great teaching opportunity for sites who do not currently have a continuous temperature monitoring device Beginning Jan 1 2018 all units that store MnVFC vaccine will be required to have a continuous temperature monitoring device (ie a data logger or a continuous temperature monitoring system) Unlike a minmax thermometer a continuous temperature monitoring device provides detailed information on all temperatures recorded at pre-set intervals For excursions it can provide information on when a temperature went out-of-range for how long and what the temperatures were This is essential information that vaccine manufacturers need to know to assess the viability of the vaccine following an excursion
Helpful information bull Sites are required to monitor and record temperatures twice daily however temperature excursions can easily occur in the 12 hours or longer between readings Continuous temperature monitoring can help manufacturers determine vaccine viability
bull Continue to encourage sites to document and evaluate minimum and maximum temperatures the storage unit reached since the last reading and respond appropriately to out-of-range temperatures
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The 2017 MnVFC Site Visit Paperwork Chapter 4
bull It is recommended that sites download and review data weekly Discuss with sites that reviewing temperature monitoring device data also includes responding appropriately if they identify out-of-range temps
bull There is sometimes confusion about the difference between a data logger and a continuous temperature monitoring system Here are some differences
Data Loggers Continuous Monitoring Systems Have an external display similar to thermometers May or may not have an external display Have a detachable probe Probe is usually attached to transmitter Need to be plugged into the computer or cradle to download information on a regular schedule
Wirelessly sends data to computer system
Create a file of data that needs to be saved on the computer
Data is stored within the system not a separate file
Doesnrsquot allow documentation of twice a day temperature checks in the file
May allow documentation of twice a day temperature checks within the system
More about the 2018 requirement for a continuous temperature monitoring device
Required Features bull The continuous temperature monitoring device must have Continuous monitoring and recording capabilities to track and record temperatures over time The capacity to routinely download temperature data to a computer (recommended at least weekly) or wirelessly transmit data Detachable probe in a bottle filled with a thermal buffer (eg bio-safe glycol) if the data logger needs to be detached in order to download data Active temperature display
Recommended Features bull MnVFC recommends continuous temperature monitoring devices with Alarm for out-of-range temperatures Accuracy within +-1degF (+- 05degC) Low battery indicator Display of current minimum and maximum temperatures Memory storage of at least 4000 readings User programmable logging intervals (eg the user can set how often the device records the temperature)
Note that these are all currently recommendations not requirements yet
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
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The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 45
Goal of this question Ensure the temperature monitoring device is properly calibrated The certificate of calibration testing means that the device has been tested and it is accurately measuring temperatures within established testing limits The certificate of calibration ensures that the device meets all the required components
Helpful information bull The provider is always responsible for having a current certificate of calibration (or copy) on-site
bull To be considered ldquovalidrdquo a certificate of calibration must contain these required elements Modeldevice name or number Serial number
4 Storage amp Handling Per Unit Certificate of Calibration Testing
Review CDC Requirement
Certificates of calibration testing provide confidence that the temperature monitoring device is measuring temperaturesaccurately All units storing VFC vaccines must have a calibrated temperature monitoring device with a current and valid certificateof calibration testing All certificates must contain modeldevice name or number serial number date of calibration testing (report or issue date) and Instrument Passed testingInstrument in Tolerance (Recommended uncertainty = +-05ordm C (+-1ordm F))
Question 45
Note to Reviewer
A
B
C
D
E
Review the certificate of calibration testing for the temperature monitoring device in this section of the storage unit and answer the questions below
bull How to determine certificate of calibration testing expiration date 1) Identify the certificate issuecalibration date 2) Apply the Immunization Program-required frequency for calibration testing Example If the
issuecalibration date is 12312013 and Immunization Program policy requires testing every twoyears the expiration date is 12312015
bull Certificates must include all of the below bull ModelDevice Name or Number bull Serial Number bull Date of Calibration Testing (Report or Issue Date) bull Instrument Passed testing (Instrument in Tolerance)
Is there a certificate of calibration testing for the temperature monitoring Yes device in this section of the storage unit No [X]
What is the date of calibration for the temperature monitoring device in this section of the storage unit
What is the certificatersquos date of expiration based on ImmunizationProgram policy (See note to reviewer to determine expiration date) [X] Follow-up is required if
certificate is expired
Does the certificate contain all the necessary items listed in the Note to Yes Reviewer No [X]
Who is responsible for supplying the current and valid certificate of Provider calibration for this temperature monitoring device
Date of calibration testing (report or issue date) Note If there is no expiration date the certificate expires 2 years from the date of calibration Whether the instrument passed or failed testing (or instrument in tolerancenot in tolerance)
bull Recommended element Documented uncertainty of +- 1degF [05degC]
If these elements are present the certificate is considered valid If the certificate contains information about the recommended element or the entity that issued the certificate that is helpful but not required
To determine if a certificate of calibration testing was issued by an appropriate entity check to see if the certificate indicates one or more of these items (this is the wording used to help sites evaluate if their calibration is accurate but is not required on the certificate itself to be considered valid)
bull Conforms to ISO 17025 bull Performed by an ILACMRA Signatory body accredited laboratory You can review this list of the ILAC MRA and Signatories (httpilacorgilac-mra-and-signatories)
bull Traceable to the standards maintained by NIST bull Meets specifications and testing requirements for the American Society for Testing and Materials (ASTM) Standard E2877 tolerance Class F (le 05 degC) or better
bull Includes reference to another acceptable accuracy validation method such as comparison to other traceable reference standards or tests at thermometric fixed points
Note CDC recommends that certifications be issued for the entire monitoring unit (detachable probe data logger etc) and not individual certificates for each component
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The 2017 MnVFC Site Visit Paperwork Chapter 4
For 45 E the provider is always responsible for supplying the current and valid certificate of calibration for a temperature monitoring device
bull Tip If the temperature monitoring device has a sticker on the back with the calibration date the site can usually call the company who calibrated the device and get a copy of the certificate if they donrsquot have one
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 46 4 Storage amp Handling Per Unit Probe Placement
Question 46 Is the probe properly placed in this section of the storage unit
Note to Reviewer ldquoProperlyrdquo means that the probe in a commercial or household unit is placed in a central area of the unitdirectly with the vaccines Probes should not be placed in the doors near or against the walls close to vents or on the floor of the unit The only allowable exemption related to this requirement is for providerswho have pharmaceutical storage units (built for vaccine storage) that have either (1) a built-intemperature monitoring device OR (2) a dedicated port for the probe that dictates the placement of theprobe
Answers (Choose one)
Yes No [X]
Review CDC Requirement
The probe must be placed in a central area of the section of the storage unit directly with the vaccines in order to properly measurevaccine temperature The probe should not be placed in the door near or against the walls close to vents or on the floor of theunit For pharmaceutical units with a built-in temperature monitoring device or a dedicated port for a probe that is not in thecenter of the section of the storage unit consult your Immunization Program for guidance on placement
Goal of this question Make sure the temperature monitoring device is in the best location to accurately measure the temperature of the vaccines stored in the unit
Helpful information bull The probe of the temperature monitoring device should be placed directly with the vaccines in the middle of the unit The ONLY allowable exception is for pharmaceutical storage units that have either a built-in thermometer or a dedicated port for the probe that indicates placement of the probe
bull Temperatures can vary within the unit especially household units bull Call MDH at 651-201-5522 if you have questions
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Guide (wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml)
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Question 474 Storage amp Handling Per Unit Temperature Documentation
Question 47 Review the temperature documentation over the past three months for this section of the storage unit todetermine whether the provider has a process in place for properly documenting temperatures twice aday Answer the questions below
A Are there two temperature readings recorded for this section of the storage unit per day
Yes No [X]
B Is there a time date and name (or initials) recorded for each reading Yes No [X]
C What is the current temperature and minmax temperatures (if available) inthis section of the storage unit Use the reviewerrsquos thermometer if the providerrsquos temperature monitoringdevice does not have a current valid certificate of calibration testing or the probe is not properly placed in this section of the storage unit
Current Temperature Minimum Temperature Maximum Temperature Fahrenheit Celsius
D Based on your review of the providerrsquos recent temperature documentationincluding the current temperature is this section of the storage unitmaintaining appropriate temperatures
Yes No [X] Not enough information [X]
Review CDC Requirement
Vaccines must be stored under appropriate temperatures as described in the package inserts at all times Acceptable temperature ranges vary by vaccine type and the range is 36deg F and 46deg F (2deg C and 8deg C) and for frozen vaccines the range is -58deg F and +5deg F (shy50deg C and -15deg C) Exposure to temperatures outside of those included in the package inserts could affect vaccine viability andultimately could leave children unprotected against vaccine-preventable diseases In order to maintain awareness of storage unittemperatures and ensure that vaccines are being stored at appropriate temperatures at all times VFC providers are required to monitor and document temperatures for all vaccine storage units at least twice a day Temperature documentation must contain (1) at least two temperature readings per day (2) the time and date of each reading and (3) the name (or initials) of the personwho assessed and recorded the readings CDC also recommends that VFC providers record the minimum and maximumtemperatures of each unit once each workday (preferably in the morning)
Goal of this question Ensure the temperature is being monitored twice daily is within the required range and documented correctly Use your thermometer to check the temperature if the sitersquos temperature monitoring devicersquos probe is not properly placed or there is not a current certificate of calibration Place your thermometer in the unit at the beginning of the visit to allow sufficient time to reach an accurate temperature The purpose of using your thermometer is to ensure the vaccine is being stored at the proper temperature not to ldquovalidaterdquo their reading
Question 47 D is an assessment question based on information you have learned during your visit You might answer ldquonot enough informationrdquo if the unit is new and they donrsquot have at least three months of data or if the unit is only used as overflow and they are inconsistent with temperature monitoring Mark ldquoNordquo if you have reason to believe the storage unit is not maintaining temperatures properly
Helpful information bull All sites must document temperatures twice a day every day the site is open even if they have a data logger or continuous monitoring system
bull Sites can document the information electronically with some continuous monitoring systems as long as it can show what the current temp is the date time and initials of the person checking ndash this needs to be someone at the site ndash not checking remotely or centrally for a large site or system The site must be able to produce these records during their site visit Reviewing these files can be a challenge due to large volumes and lots of paper
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Temperature Logs on Managing Vaccine (wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml)
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Question 484 Storage amp Handling Per Unit Temperature Excursions
Question 48 In the event that a temperature excursion(s) occurred in this unit within the last three months requestand review documentation of actions taken to determine whether the provider has a process for properlyaddressing excursions Answer the questions below
A Were vaccines in this unit exposed to out-of-range temperatures in the lastthree months (including today)
Yes No (If no skip to question 49)
B Did the provider quarantine and label vaccines as ldquoDo not userdquo Yes No [X]
C Did the provider place vaccine in a unit where it can be stored under properconditions if applicable
Yes No [X]
D Did the provider contact the Immunization Program to report theexcursion
Yes No [X]
E Was the manufacturer contacted for documentation supporting theusability of the vaccine
Yes No [X]
Review CDC Requirement
The provider must document all excursions and actions taken including the following (1) Quarantine and label vaccines as ldquoDO NOTUSErdquo (2) Place vaccines in a unit where they can be stored under proper conditions (3) Contact the Immunization Program to report an excursion and (4) Contact the vaccine manufacturer to obtain documentation supporting the usability of the vaccine
Goal of this question Address any out-of-range temperatures (temperature excursions) identified in reviewing the last three months of temperature logs or during the site visit If there were any out-of-range temperatures did the site respond appropriately to the situation This is a great opportunity to discuss what to do in the event of an excursion The Clinicians Storage and Handling Mishap Checklist is in the IPI Site Visit information folder and is a good review of the process
Helpful information bull Sites need to know that an excursion does not automatically mean that exposed vaccines are non-viable or unusable Exposed vaccines must be quarantined (marked ldquoDo Not Userdquo) and stored under proper conditions until they have received information from vaccine manufacturers regarding the viability of the vaccine
bull Sites must inform MDH when an excursion occurs
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Clinicians Storage and Handling Mishap Checklist (wwwhealthstatemnusdivsidepcimmunize ipivaxchklstpdf)
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Question 49
Goal of this question Ensure proper placement of vaccines in the storage unit
Note These are all recommendations (best practices) not requirements
Helpful information bull Store vaccine in the middle of the compartment two to three inches away from the coils walls floor and cold air vent The temperature near the floor and walls of the unit differs from that in the middle of the compartment and the cold air vent can freeze refrigerated vaccines
4 Storage amp Handling Per Unit Vaccine Placement
Question 49 Look inside the unit to answer the questions below
A Are vaccines placed in the middle of the unit with space between vaccinesand the sideback of the unit to allow cold air to circulate
Yes No [O]
B Are vaccines stored in their original packages Yes No [O]
C Are there water bottles (for refrigerators) or frozen water bottles (forfreezers) in the unit
Yes No [O]
D Are vaccines store in the doors vegetable bins under or near cooling ventsor on the floor of the unit
Yes [O] No
E Is food being stored in the unit Yes [O] No
Review CDC Recommendation
Vaccines should be stored in their original manufacturer (or CDC centralized distributor) packaging They should be placed in the middle of the unit with space between the vaccines and the sideback of the unit to allow cold air to circulate Vaccines SHOULD NOT be stored in the doors vegetable bins or floor of the unit or under or near cooling vents and there should not be any food inthe unit Water bottles (for refrigerators) or frozen water bottles (for freezers) should be placed throughout each storage unit inorder to (1) stabilize or extend temperatures during a power outage and (2) to serve as physical blocks preventing the placementof vaccines in areas of the unit that are at higher risk for temperature excursions (such as in doors vegetable bins floor ornearunder cooling vents)
bull Vaccines should be kept in their original packaging to Protect them from light Help prevent medication errors by making labels easier to read Provide a moisture barrier that serves as insulation in case of an out-of-range temperature power outage door left open or mechanical failure Simplify managing vaccine inventory
bull Store water bottles in the doors on the floor and near the cold air vent in the refrigerator and frozen water bottles in the freezer to help maintain a stable temperature if there is a power failure and when the door is opened frequently Too many water bottles in the door can prevent the door from closing tightly Mark water bottles ldquoDo Not Drinkrdquo
bull Do not store vaccine in the door or drawers of the refrigerator or freezer Vegetable bins and crisper drawers should be removed from refrigerators or used to store other medical supplies or water bottles
bull If vaccine is stored in a household combination refrigeratorfreezer The top shelf should not be used for storing vaccine because the cold air vent blowing from the freezer will freeze vaccine located there If you must use the top shelf of this type of unit place water bottles underneath the cold air vent to prevent vaccine from being stored there It is recommended that only the refrigerator be used for vaccine storage and a separate stand-alone freezer be used to store frozen vaccine
bull Must not store food or beverages in the refrigerator or freezer because frequent opening of doors can lead to temperature variations that may affect vaccine viability There is also a risk of contaminating vaccines
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Guide (wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml) bull Vaccine Storage Tip Sheet on IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml)
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The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 4104 Storage amp Handling Per Unit Disconnection from Power Source
Question 410 Ask the provider to demonstrate what measures are taken to ensure that vaccine storage units are notaccidentally physically disconnected from the power supply Which of the following describes the measure(s) taken on this unit
Note to Reviewer bull Large hospitals and healthcare systems may not have the ability to demonstrate labels on plugs or circuitbreakers In such cases verify that the practice has a comprehensive policy and standard operatingprocedures in place to prevent the vaccine storage unit from being physically disconnected from thepower supply
bull While back-up generators may ensure power to the overall facility this question ONLY addresses thevaccine storage unit being accidentally disconnected from the power source either through the plug orthe circuit breaker
Answers A ldquoDo not disconnectrdquo labels on the plug (Choose all that B ldquoWarningrdquo label on the circuit breaker box
apply) C Hard-wired (ie built-in) and has a ldquoDo not disconnectrdquo label on thecircuit breaker box D Hospital or large health care system with a comprehensive written policyand standard operating procedures detailing measures taken to preventvaccine storage units from being accidentally disconnected from the powersupply E No acceptable measures for preventing accidental disconnection frompower supply [X]
[X] The response is non-compliant if only A only B or E is selected
Review CDC Requirement
VFC providers must take steps to protect the power source for all vaccine storage equipment by means of having clear warninglabels on both the plug and the circuit breaker associated with all vaccine storage units Large hospitals and healthcare systems canmeet this requirement by demonstrating that they have comprehensive policies and standard operating procedures to preventvaccine storage units from being physically disconnected from the power supply
Goal of this question Decrease the chance that a vaccine storage unit will be accidently unplugged or power will be turned off while vaccine is in the unit This question addresses only what measures the site has taken to ensure the storage unit is not physically disconnected from its power source
If the site uses labels on the plugs and circuit breakers perform a visual inspection to assess whether the way the stickers are positioned make it clear and obvious to anyone that these units are not to be disconnected
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Do Not Unplug and Warning stickers are included in the folder or available to order on the For
Professionals Order Form (wwwhealthstatemnusdivsidepcimmunizeordermathtml)
Note Once you have completed the 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet for each unit return to the questionnaire to complete sections 5 and 6
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-
- -
Section 5 Storage amp Handling Site-Wide Question 51
5 Storage amp Handling Site Wide Discussion of Cost amp Quantity of Vaccine
Question 51 Have a discussion with the provider about the cost and quantity of VFC vaccines they are responsible for annually Address the points listed in the note to reviewer below
Note to Reviewer bull Vaccine Shipped (Required) Share the cost of VFC vaccines shipped to the provider in the last calendaryear to make sure the provider understands the contribution made by the VFC Program to their practiceFor new providers who do not have ldquocalendar yearrdquo data share either the actual cost of their currentinventory or use the cost of 10 VFC doses of each of the ACIP-recommended vaccines (approximately $7000) to help estimate their annual cost
bull Storage amp Handling (Required) Make sure the provider understands the cost of vaccines for which they are responsible when they make decisions about purchasing recommended vaccine storage and temperature monitoring equipment
Answer I have discussed with the provider the cost and quantity of vaccines ordered in the previous calendar year
Goal of this question Inform sites of the quantity and value of vaccines that they receive as part of the MnVFC program Providers often donrsquot realize the value of the vaccine in their unit This information is included on your clinic list and on the one page site-specific information
Helpful information bull This discussion must occur and the box on the questionnaire must be checked bull If there isnrsquot actual vaccine value information available tell the site that one vaccine order that includes a box of each of the ACIP recommended vaccines costs approximately $7000
bull MDH may not have specific information for individual sites if they receive vaccine from a central warehouse or pharmacy For those sites MDH will give you numbers for the whole system so you can discuss system wide data as appropriate If individual site information is also included it is usually just varicella-containing vaccines that must be shipped directly to the site
Question 52
5 Storage amp Handling Site Wide Dorm Style Units
Question 52 Determine whether the provider has any dorm-style units on site and answer the questions below
Note to Reviewer A dormitory-style refrigerator is a unit that has both refrigerator and freezer compartments behind a singleexterior door Dorm-style units also have an evaporator plate (cooling coil) which is usually located insidean icemaker compartment (freezer) within the refrigerator
A Does the provider have any dorm-style units that are used at any time tostore vaccines
Yes [X] No (Skip to question 53)
B Does the provider have sufficient space in existing compliant vaccinestorage units to store all vaccines without use of the dorm-style unit at any time
Yes No [X]
Review CDC Requirement
Dorm- and bar-style units are prohibited for vaccine storage Vaccines stored in dorm-style units are considered non-viable and must be returned to the centralized distributor CDC recommends the following vaccine storage unit types (in order of preference)pharmaceutical grade stand-alone or combination units (preferred) householdcommercial stand-alone unitshouseholdcommercial combination units using the refrigerator section only
Goal of this question Ensure no vaccine is stored in dorm-style units even for short periods of time Encourage them to label any units ldquoNo Vaccine Storage Allowedrdquo Vaccine stored in these units is considered non-viable If a site is using a dorm-style unit call the MnVFC program (651-201-5522)
Resource Section 8 in the MnVFC Policies and Procedures Manual
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-
Question 535 Storage amp Handling Site Wide Storage Unit Space Availability
Question 53 Does the provider have sufficient room across storage units to store current stock as well as anyadditional stock acquired during peak season without overcrowding
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have sufficient storage space to accommodate vaccine stock at the busiest time of year without overcrowding
Goal of this question Ensure that sites have sufficient space in their units to maintain vaccines at the busiest time of year Overcrowding of vaccine limits air circulation and affects the unitrsquos ability to maintain stable temperatures
Helpful information bull Look for signs of overcrowding such as vaccines that are pushed up against the wall bins that are overflowing or storage units that are full during non-peak seasons
Discuss immediate actions if the unit is overcrowded Move some of their vaccines order less vaccine more frequently (once per month preferably) andor purchase another storage unit for overflow
Resource bull Section 8 MnVFC Policy and Procedure Manual
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-
Question 545 Storage amp Handling Site Wide Expired Vaccines
Question 54 Look in each unit Are there expired vaccines in any of the vaccine storage units at this site
Answers (Choose one)
Yes [X] No
Review CDC Requirement
Vaccines should be rotated weekly and when a new shipment comes in so that longer-dated vaccines are stored behind shorter-dated vaccines If vaccines expire they can no longer be stored in the same storage unit with viable vaccines They must be placedin a container or bag clearly labeled ldquoDo not userdquo and separated from viable vaccines to prevent inadvertent use Expired vaccinemust be returned to the centralized distributor within six months of expiration
Goal of this question Ensure there is no expired vaccine in any storage unit
Helpful information bull Sites can prevent their stock from expiring by rotating vaccines every week andor when a new shipment arrives Longer-dated vaccines are stored towards the back of the unit and shorter-dated vaccines are up front
bull Pay attention to vaccines that expire within the next three months Consider transferring vaccine that will expire soon to another MnVFC-enrolled site that will use the vaccine preferably a site close by It is the transferring sitersquos responsibility to arrange the transfer of the vaccine Be sure to complete the MDH Vaccine Transfer Record form and send it to MDH If they are having difficulty finding a location to accept vaccine contact MDH
bull This is a great opportunity to educate sites about the MDH Nonviable Vaccine Form and the process for returning vaccine The VFC program does get some credit for taxes and fees on vaccine that is returned to the distribution center
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MDH Nonviable Vaccine Form and MDH Vaccine Transfer Record on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfcformshtml)
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The 2017 MnVFC Site Visit Paperwork Chapter 4
- -
-
Question 555 Storage amp Handling Site Wide Back up Thermometer
Question 55 Does the provider have a readily available back-up thermometer with a current and valid certificate ofcalibration testing
Note to Reviewer ldquoReadily availablerdquo means that the thermometer is available to perform twice-a-day monitoring for a unit asrequired CDC recommends that the back-up thermometer be maintained on site
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have a readily available back-up thermometer with a current and valid certificate of calibration testing Toprevent the certificates of calibration testing of the primary and back-up thermometers from expiring at the same time the date of calibration testing (or issue date) of the back-up thermometer should be different from the date of calibration testing (or issue date) of the primary thermometer As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meetsVFC program requirements
Goal of this question Ensure sites have one calibrated back-up thermometer onsite that is readily available in the event that the temperature monitoring device in unit fails transportation of vaccine is needed or there are other unexpected circumstances
Helpful information bull As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meets VFC Program requirements
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 56 5 Storage amp Handling Site Wide Preparation of Vaccine
Question 56 When does this provider prepare vaccine for administration to the patient
Note to Reviewer For mass vaccination clinics if one type of vaccine is offered providers may pre-draw up to 10 doses Ifusing pre-filled syringes pre-drawing also means activating the syringe by removing the needle guard orattaching a needle
Answers (Choose all that
apply)
Prepare dose immediately before administration Pre-draw doses for upcoming patients (in a regular clinicpractice) [O] Pre-draw up to 10 doses (in a mass-vaccination clinic) Pre-draw more than 10 doses (in a mass-vaccination clinic) [O] Other [O]
Review CDC Recommendation
CDC recommends preparing vaccines immediately prior to administration in order to assure viability of vaccine and prevent vaccinewastage Vaccines that are not administered immediately are at risk of exposure to temperatures outside of the required rangewhich can affect vaccine viability and ultimately can leave children unprotected against vaccine-preventable diseases
Goal of this question Discuss proper timing and preparation of vaccine(s) for administration These are recommendations not requirements
Helpful information bull Educate staff on the importance of preparing vaccine immediately before administration Pre-drawing of vaccines may lead to concerns related to vaccine viability potency sterility and wastage
Page 46 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 6 Inventory Question 61
6 Inventory Inventory Comparison
Question 61 Visually inspect storage units to determine if existing supply of vaccines proportionately mirrorspopulations served Choose the most accurate statement below
Note to Reviewer bull CDC recommends that providers maintain a four-week supply of inventory bull For this question do not take into account vaccine types that the provider does not order Here simply
make sure that overall the vaccines in the providerrsquos storage units are available in sufficient amounts toserve their patient population
Answers (Choose one)
The current vaccine inventory proportionately reflects the populations identified Only public stock is insufficient [X] Only private stock is insufficient [X] Both public and private stock are insufficient [X] Site uses the replacement method but does not appear to have enough vaccine for their population [X] Other [X]
Review CDC Requirement
VFC providers must order and stock routine vaccines in accordance with their patient population in order to prevent missedvaccination opportunities Having sufficient amounts of all stocks prevents the inadvertent use of VFC vaccines for non-VFC-eligiblepatients and vice versa
Goal of this question Assess whether the site is ordering appropriate quantities of vaccine for the population they serve at their site
Helpful information bull If the site sees 30 percent private-pay patients and 70 percent VFC the stock in their storage units should reflect that proportion If you donrsquot know you can ask the site about their population
bull This is meant to be a general assessment so in a big site if they have only a small amount of vaccine that may indicate an issue with vaccine management
bull CDC recommends smaller more frequent orders (ie monthly) rather than large orders to minimize the amount of vaccine loss if an incident occurs during shipment or in the storage unit Sites should not order more frequently than once a month
bull Sites using the replacement method will only have one stock but it should appear to be large enough for their population
bull Only assess the vaccine types that the site currently stocks in their unit We know there are sites that do not offer all ACIP-recommended vaccines for various reasons That issue will be addressed in question 62
IPI Advisor Manual | February 2017 Page 47
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 626 Inventory ACIP Recommended Vaccines
Question 62 Review providerrsquos current inventory to answer the questions below
A Does the provider offer all routine ACIP-recommendedvaccines for their patient population
Yes (Skip to question C) No [X] Offers all except varicella because direct ship ofvaccine is unavailable from manufacturer
B Which routine vaccines are NOT being offered DTaP Hepatitis A Hepatitis B HIB HPV Influenza Meningococcal
MMR Pneumococcal Polio Rotavirus TdapTd Varicella
C According to Immunization Program Policy does theprovider make accessible all non-routine ACIP-recommended vaccines for those VFC patients whomeet the criteria for receiving them
Yes (Skip to question 63) No [X]
D Which non-routine vaccines are NOT being offered Pneumococcal polysaccharide vaccine (PPSV23) Meningococcal Group B (MenB) Other
Review CDC Requirement
VFC providers agree to comply with immunization schedules dosages and contraindications that are established by the Advisory Committee on Immunization Practices (ACIP) for the vaccines identified and agreed upon in the Provider Agreement UNLESS bull In the VFC providers medical judgment and in accordance with accepted medical practice the VFC provider deems such
compliance to be medically inappropriate for the child bull The particular requirements contradict state law including laws pertaining to religious and other exemptions The VFC program entitles children to the following vaccines DTaP Hepatitis A Hepatitis B HIB HPV Influenza MeningococcalMMR Pneumococcal Polio Rotavirus TdapTd and Varicella VFC providers are also required to ensure that VFC-eligible children have access to non-routine vaccines as needed
Goal of this question Assess if the site is offering all the ACIP-recommended vaccines for the population they serve and these vaccines are in stock on the day of the visit It is important that every MnVFC-eligible child that comes to a providerrsquos office for an immunization is vaccinated
Helpful information bull The Advisory Committee on Immunization Practices (ACIP) is a group of medical and public health experts that develops recommendations on how to use vaccines to control diseases in the United States
bull Specialty providers are not required to offer all routine vaccines but should provide the vaccines appropriate for their population
bull If the site does not offer all routine ACIP-recommended vaccines appropriate for their population check the ldquoNordquo box in Part A then check the appropriate box(es) in Part B for any vaccines not offered Please contact MDH as this situation offers us the opportunity to provide education to the site
bull For non-routine vaccines they must either be in stock or the site must have an alternative protocol in the routine management plan that ensures these children have access when applicable
Resources bull IAC Diseases and Vaccines (wwwimmunizeorgvaccines) bull CDC Advisory Committee on Immunization Practices (ACIP) (wwwcdcgovvaccinesacipindexhtml)
Page 48 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 636 Inventory Separation of Stock
Question 63 Observe how the provider differentiates stock in each storage unit to answer the questions below
A Is it clear which vaccines belong to public stock andwhich belong to private stock
Yes No [X] Not applicable replacement site
B Is it clear which vaccines belong to VFC stock andwhich belong to UUAV stock
Yes No [X] Not applicable replacement site Not applicable not UUAV-enrolled site
Review CDC Requirement
In order to ensure that VFC vaccines are only administered to VFC-eligible children VFC providers that serve both VFC and non-VFCshyeligible children must maintain their vaccine inventories in such a way that they can clearly differentiate public stock from privatestock as well as VFC from other public stock
Goal of this question Assess whether the site can distinguish between MnVFC vaccine and private vaccine If they participate in the Uninsured and Underinsured Adult Vaccine (UUAV) program they should also be able to distinguish between MnVFC stock and UUAV stock Some sites use labels bins boxes etc to differentiate their stock If it is not clear how the site differentiates their stock discuss vaccine management with the staff For follow-up call MDH to discuss doing a follow-up site visit
Sites using the replacement method will not have separate stocksmdashthis is an approved alternative method for keeping track of vaccine
Resource bull Section 10 of the MnVFC Policy and Procedure Manual
IPI Advisor Manual | February 2017 Page 49
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
MnVFC Site Visit Storage and Handling Per Unit Answer Sheet 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet MnVFC PIN ___________________
Question number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
Temperature Monitoring Device Questions Questions 43 47 must be answered separately for the freezer and refrigerator if the unit is a combo Be sure to document responses in the appropriate column
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
All the questions on the Site Visit Storage amp Handling Per Unit Answer Sheet have been discussed previously in section 4 of this manual Use this sheet to record information about all the units at the site visit You will need one sheet for each unit If it is a combination unit (either pharmaceutical or household) you can record both sections on one sheet If they have stand-alone units use one sheet for each unit Do not enter the answers to the questions in section 4 of the questionnaire
If you need more information about any of the questions refer back to the main questionnairemdashthe complete question additional guidance including notes to the reviewer and the CDC requirements are there Also if the site is not meeting the requirement you will go back to the questionnaire to complete the ldquoActions if Non-compliantrdquo section including the root cause analysis and follow-up sections
When you have completed the assessment of all the storage units remember to go back to the questionnaire to complete sections 5 and 6
Page 50 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
ndash
ndash
MnVFC Provider Follow-up PlanThe goal of the Provider Follow-up Plan is to communicate with the site all of the VFC requirements any unmet requirements found during your site visit and the timeline for completing the required action The left hand column is a box to check for ldquoUnmetrdquo requirements
Helpful information bull The form can be used to review what the site is doing well and what they need to work on
bull For requirements that have specific documentation that needs to be sent to you use the notes section
2017 MnVFC Provider Follow-up Plan Site _______________________________________________ MnVFC PIN ____________ Date of Visit ___________
Thank you for participating in this MnVFC compliance site visit Please review this visit summary including follow-up actions and timelines for completion Unmet MnVFC requirements and recommendations have a checked box next to them The goal of this plan is to support you with successfully implementing the program and improving access to vaccines for VFC-eligible children
Unmet Question VFC Requirements Section 1 Changes to Key Staff
Q12 Change in the Medical Director Immunization Manager Vaccine Coordinator or back-upKey Staff must be communicated to the immunization program by emailing healthmnvfcstatemnus Changes Notes
Q12 Key staff must complete the annual training on VFC program requirements and print theAnnual Training certificate of completion Documentation Required Action
Staff that have not completed the MnVFC online training must complete it and send acopy of the certificate to the reviewer Training can be found on the MnVFC website (wwwhealthstatemnusvfc) Due date 1 month
Notes
Unmet Question VFC Requirements Section 2 Eligibility
Q21 Provider staff must possess a working knowledge of all VFC eligibility criteria and use thoseVFC Eligibility criteria to screen children prior to administering VFC vaccines
Categories Notes
bull This form provides documentation needed for follow-up actions when you send your thank you email
The second to last page of the Provider Follow-up Plan has a summary of the MnVFC program recommendations These are to remind the site about best practices they may want to improve upon even though they are not yet requirements of the program For example you could discuss the recommendation about storage units if they currently have a combination household unit and are using both sections
The last section is for your signature and the person you met with In most sites it will be the immunization manager or vaccine coordinator who signs the form unless the medical director attended the site visit You keep the original copy and the site will need to keep a copy for themselves
To be completed by the site visit reviewer
I acknowledge that a VFC site visit was performed on __________________ (visit date) The follow-up plan which includes a list of all current VFC program requirements and recommendations assessed during the visit and any required follow-up actions was provided at the end of the visit
Site visit reviewer
Phone
Reviewer Signature Date
To be completed by the provider
I acknowledge that our practice took part in the VFC site visit noted above I understand the findings of the visit and any required actions that must be taken by our office in order to meet VFC program requirements
Medical Director (or designee) Name Title
Medical Director (or designee) Signature Date
IPI Advisor Manual | February 2017 Page 51
The 2017 MnVFC Site Visit Paperwork Chapter 4
After the Site Visit Send a thank you email highlighting the unmet requirements documents you need from the site to resolve the issue(s) and the date you need them Make sure to include the link to the Site Visit Survey (httpssurveyvovicicomseashxs=56206EE334CE0B14)
Please refer to Chapter 3 for more information about future follow-up required after the visit including forms and documentation
Resource bull Sample Thank You letter on IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml)
Chapter 5
IPI Advisor Resource List MnVFC Program 651-201-5522
MnVFC wwwhealthstatemnusvfc
bull Separate Stock and Replacement Method Policies and Procedures Manuals bull Online trainings bull MnVFC Announcements sign up to receive them via email bull Ordering MDH vaccine bull MnVFC forms Screening forms Reporting forms Others MDH Nonviable Vaccine Form MDH Vaccine Transfer Record and Vaccine Borrowing Report
bull MnVFC promotional materials bull Immunization Billing Guidance for MnVFC and Immunization Billing Guidance for MnVFC Replacement Sites Immunization Practices Improvement Program (IPI) wwwhealthstatemnusdivsidepcimmunizeipi
bull IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml) bull IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml) IPI Resource Folder Contents (wwwhealthstatemnusdivsidepcimmunizeipiipifolderpdf)
Minnesota Immunization Information Connection (MIIC) wwwhealthstatemnusmiic
bull MIIC regions and regional coordinators
Clinical Practice MDH Immunization Program wwwhealthstatemnusimmunize
Got Your Shots News wwwhealthstatemnusdivsidepcnewslettersgys
MDH Immunization Information for Health Care Providers wwwhealthstatemnusdivsidepcimmunizehcp
bull Got Your Shots A Providers Guide to Immunization in Minnesota bull Vaccine protocols bull Forms for tracking patient immunizations bull Immunization schedules for Health Care Providers Immunization Action Coalition (IAC) wwwimmunizeorg
bull Ask the Experts bull VISs (Vaccine Information Statements and translations) bull Administration screening questions bull Medical management of vaccine reactions bull Order form for Californiarsquos Immunization Technique DVD Best Practices with Infants Children and Adults
Page 52 IPI Advisor Manual| February 2017
IPI Advisor Resource List Chapter 5
CDC ldquoPink Bookrdquo wwwcdcgovvaccinespubspinkbookindexhtml
CDC Advisory Committee on Immunization Practices (ACIP) wwwcdcgovvaccinesacip
CDC Vaccines and Immunizations wwwcdcgovvaccines
VAERS reporting httpvaershhsgovindex
Storage and Handling Got Your Shots Providers Guide ndash Managing Vaccine wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml
MnVFC Guide to Temperature Monitoring Devices wwwhealthstatemnusvfc
MDH Clinicianrsquos Vaccine Mishap Checklist wwwhealthstatemnusdivsidepcimmunizeipivaxchklstpdf
MDH Vaccine Storage Guide wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml
CDC Vaccine Storage and Handling Toolkit wwwcdcgovvaccinesrecsstoragetoolkit
You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Vaccine manufacturer phone numbers wwwcdcgovvaccinespubspinkbookdownloadsappendicesFcontact-info-manufactpdf
IAC Checklist for Safe Vaccine Handling and Storage wwwimmunizeorgcatgdp3035pdf
IAC Donrsquot Be Guilty of These Errors in Vaccine Storage and Handling wwwimmunizeorgcatgdp3036pdf
Additional Resources Print materials from MDH ndash order forms wwwhealthstatemnusdivsidepcimmunizeordermathtml
Vaccine Education Center ndash Childrenrsquos Hospital of Philadelphia wwwchopeduservicevaccine-education-centerhomehtml
California Department of Public Health ndash Interactive training on vaccine administration and storage and handling handout on transporting vaccine and how to package wwwezizorg
IPI Advisor Manual | February 2017 Page 53
IPI Advisor Resource List Chapter 5
CDC vaccine price list wwwcdcgovvaccinesprogramsvfcawardeesvaccine-managementprice-listindexhtml
Vaccine Information Statements (VIS) wwwcdcgovvaccineshcpvisindexhtml
CEU Opportunities CDC Immunization Education and Training wwwcdcgovvaccinesedindexhtml
Immunization You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Page 54 IPI Advisor Manual| February 2017
- Introduction
-
- Welcome to the Immunization Practice Improvement (IPI) Program
- Contact Information
-
- Chapter 1
- Requirements to Participate in the MnVFC Program
- Vaccines for Children Program
- Chapter 2
- Reimbursement for MnVFC Visits
- Types of Visits
- Your MnVFC Clinical CoordinatorPlanner
- New IPI Advisor Training Requirements
- Your Role as an IPI Advisor
- Reasons MDH Would Do All or Part of a Visit
- Chapter 3
- Future follow-up
- Conducting the Visit
- Preparing for the Visit
- Information for the Visit
- Site Visit Checklist
- Scheduling the Visit
- Chapter 4
- After the Site Visit
- MnVFC Provider Follow-up Plan
- MnVFC Site Visit Storage and Handling Per Unit Answer Sheet
- Section 6 Inventory
- Section 5 Storage amp Handling Site-Wide
- Section 4 Storage amp Handling Per Unit
- Section 3 Documentation
- Section 2 Eligibility
- Section 1 Provider Details
- The Site Visit Reviewer Legend
- MnVFC Site Visit Questionnaire
- Required Paperwork for Site Visits
- Chapter 5
-
Chapter 1
The Immunization Practices Improvement Program The goal of the Immunization Practices Improvement (IPI) Program is to help ensure that all eligible children receive viable vaccine at low or no cost
The Minnesota Department of Health (MDH) contracts with local public health departments to provide IPI services in their community IPI advisors from these departments complete site visits at MnVFC- enrolled sites in their county Local public health (LPH) staff often already have a relationship with primary care providers in their community and if not visits may help facilitate building relationships and sharing information Visits ensure enrolled sites meet the following objectives
bull Adhere to MnVFC eligibility and programmatic requirements and recommendations bull Manage vaccines to ensure proper storage and handling and minimize waste bull Administer and document vaccines according to current immunization guidelines
Vaccines for Children Program The Vaccines for Children (VFC) Program is a federal entitlement program which provides vaccines to children whose parents or guardians may not be able to afford them This helps ensure that all children have a better chance of getting their recommended vaccinations on schedule Vaccines available through the VFC Program are those recommended by the Advisory Committee on Immunization Practices (ACIP) (wwwcdcgovvaccinesacipindexhtml) These vaccines protect babies young children and adolescents from 16 diseases
Funding for the VFC program is approved by the Office of Management and Budget (OMB) and allocated through the Centers for Medicare amp Medicaid Services (CMS) to the Centers for Disease Control and Prevention (CDC) CDC buys vaccines at a discount and distributes it to grantees (ie state health departments) who then distribute the vaccine at no charge to enrolled sites
History of the Vaccines for Children Program
From 1989 - 1991 a measles epidemic in the United States resulted in tens of thousands of cases of measles and hundreds of deaths Upon investigation CDC found that more than half of the children who had measles had not been immunized even though many of them had seen a health care provider
In partial response to that epidemic Congress passed the Omnibus Budget Reconciliation Act (OBRA) on Aug 10 1993 creating the Vaccines for Children (VFC) Program VFC became operational Oct 1 1994 Known as section 1928 of the Social Security Act the VFC Program is an entitlement program (a right granted by law) for eligible children age 18 and younger
Minnesota Vaccines for Children Program
The Minnesota Vaccines for Children (MnVFC) program is Minnesotarsquos version of the federal VFC program By collaborating with over 820 sites throughout Minnesota MnVFC provides vaccines at no cost to children who may not otherwise be vaccinated because of the inability to pay Approximately one-third of Minnesota children are eligible for the MnVFC program These are children who are 18 years of age or younger and fall into one of the following categories
IPI Advisor Manual | February 2017 Page 5
The IPI Program Chapter 1
bull Uninsured bull Enrolled in a Minnesota Health Care Program Medical Assistance (MA) or MinnesotaCare bull American Indian or Alaskan Native or bull Underinsured children that are seen at a local health department Federally Qualified Health Center (FQHC) or Rural Health Center (RHC) Indian Health Services (IHS) and tribal health clinics
The majority of pediatric and family practice clinics are enrolled in MnVFC so children can stay with their health care home and still receive low-cost immunizations
When Congress enacted the VFC program they wanted to ensure that bull Sites manage their VFC vaccine appropriately so that there is little to no wastage of this valuable asset bull All eligible children receive the vaccine bull Immunization coverage rates increase by removing barriers to vaccination especially among high-risk children and by reducing disparities in access to health care
bull Vaccine is not used for the purpose of gaining profit for the provider or site
To assure these goals are achieved all states are required to conduct site visits for each enrolled site at least every other year As an IPI advisor you will be conducting the required MnVFC site visits in your county
Minnesota receives approximately $48 million of federally funded vaccine through the MnVFC program each year It is extremely important that these vaccines are managed properly and given only to the individuals that are eligible to receive them
Requirements to Participate in the MnVFC Program Initially providers must go through an enrollment process with MDH to receive vaccine from the MnVFC program This requires filling out the enrollment paperwork meeting the requirements in the appropriate MnVFC Policies and Procedures Manual and having an enrollment site visit by MDH staff
Following enrollment all sites receive their first MnVFC site visit within one year (preferably in 3-6 months) and then a MnVFC site visit at least every other year If you know of a provider who is not enrolled in the program a new clinic opens or if a site opens a satellite site in your county have them call the MnVFC program at 651-201-5522 to begin the enrollment process
Sites must meet many requirements to receive vaccine from the MnVFC program These requirements are identified in the MnVFC Policies and Procedures Manual There are two versions of the manual one for sites that keep separate stocks of public and private vaccine and another for sites that use the replacement method of vaccine management A copy of the appropriate manual is mailed to each site every fall The immunization manager vaccine coordinator and their back-ups must complete the annual online training based on the method of vaccine management their site uses All of the materials can be found on the MnVFC website (wwwhealthstatemnusvfc) Sites must complete the appropriate reports agreements and online training each year in order to continue to receive vaccine from the MnVFC program
Page 6 IPI Advisor Manual| February 2017
Chapter 2 IPI Advisors Your Role as an IPI Advisor As part of an MDH grant agreement with community health boards MDH contracts with local public health agencies to conduct MnVFC site visits in their county
As an IPI advisor you will be responsible for bull Attending the annual training provided by MDH bull Reviewing your county site visit lists and providing any known updates to your MnVFC clinical coordinatorplanner
bull Conducting site visits completing and submitting paper work within 10 days of the visit bull Following up with sites for unmet requirements identified at MnVFC site visits bull Notifying MDH when new sites open that will be storing and administering immunizations (in order to recruit new providers)
bull Keeping up-to-date with new recommendations and requirements for immunizations as well as the MnVFC program Read and be familiar with MnVFC and IPI web pages Sign up to receive email alerts for these resources by clicking on the red envelope at the top of these pages MnVFC Announcements (wwwhealthstatemnusdivsidepcimmunizemnvfcbfaxhtml) Got Your Shots News newsletter (wwwhealthstatemnusdivsidepcnewslettersgysindex html) Immunization Practices Improvement Program (wwwhealthstatemnusdivsidepc immunizeipiindexhtml)
Be designated as the IPI contact in Workspace (httpsoephealthstatemnusworkspace) for your organization Contact your organizationrsquos Workspace administrator to assign you this role
Annual training
Every spring MDH provides training for IPI advisors This training may be in-person or by webinar All IPI advisors are required to attend training each year to review site visit paperwork hear updates on the MnVFC program and ask questions about the process
Clinic lists
Early in the year MDH will send you a clinic list Your list will include all sites in your county that are enrolled in the MnVFC program The priority column indicates whether the IPI advisor MDH staff or the field epidemiologist should complete the visit Those sites not due for a visit that year will have the next year listed Every active MnVFC site is required to receive a site visit at least every other year You can do visits every year if you would like but this is not required Please review the list and notify your MnVFC clinical coordinatorplanner about any changes
IPI Advisor Manual | February 2017 Page 7
IPI Advisors Chapter 2
Included with the list is a one-page information sheet for each site This contains the sitersquos demographic information vaccine coordinator and immunization manager listed in our records whether they are a separate stock or replacement site and the doses and cost of vaccine they received last year Confirm this information with the site and discuss their vaccine quantity and value as part of the questionnaire during your visit
All site visits must be completed by Sept 30 2017 If you think you will be unable to complete all your visits by then you will need to contact your MnVFC clinical coordinatorplanner to determine how the visit will be completed
New IPI Advisor Training Requirements New IPI advisors need to contact MDH before performing any MnVFC site visits on their own A MnVFC clinical coordinatorplanner will help you prepare to perform site visits They will
bull Guide your training See the Training Checklist for IPI Advisors on the IPI Program Resources (wwwhealthstate mnusdivsidepcimmunizeipiresourceshtml) page
bull Have you shadow them or another experienced IPI advisor on one or two site visits bull Shadow you on a visit or two bull Complete the training document
Your MnVFC Clinical CoordinatorPlanner Your MnVFC clinical coordinatorplanner is a MDH staff member that will help support you See who your clinical coordinatorplanner is on IPI Contact Information (wwwhealthstatemnusdivsidepc immunizeipicontacthtml)
The role of the MnVFC clinical coordinatorplanner bull Provide assistance to IPI advisors bull Perform enrollment visits for new sites that will be administering MnVFC vaccine bull Review MnVFC site visit paperwork for accuracy bull Conduct MnVFC site visits where necessary bull Provide additional education or follow-up with sites bull Provide assistance and guidance regarding MnVFC requirements and recommendations to sites bull Provide training to IPI advisors and staff at MnVFC-enrolled sites bull Field storage and handling incident calls
Types of Visits MnVFC Site Visit ndash also known as the Compliance Visit
CDC requires all state immunization programs to conduct site visits to all VFC providers MnVFC site visits are required every other year but sites can be visited on a yearly basis if needed The site visit objectives are to
Page 8 IPI Advisor Manual | February 2017
IPI Advisors Chapter 2
bull Complete the MnVFC site visit paperwork found on IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml)
bull Provide education about MnVFC program requirements and recommendations to site staff bull Ensure MnVFC program requirements are properly implemented and are being met bull Provide feedback and as necessary execute corrective action bull Follow-up on identified issues bull Notify your MnVFC clinical coordinatorplanner of issues that are not resolved by the due date
Follow-Up Visit
In-person follow-up visits will not be necessary for most MnVFC site visitsmdashonly those where significant issues are identified in the original visit If you are not able to complete part of the initial site visit because you found a storage and handling incident or you found multiple issues that need to be addressed a follow-up visit may be necessary Please contact the MnVFC clinical coordinatorplanner for approval and guidance for conducting a follow-up site visit
Educational Visit
Some sites may need more information and education than you can provide during a normal site visit This may be on topics related to immunizations immunization practices or administration or storage and handling issues These visits go beyond the sharing of pamphlets resources or information that is presented at a site visit Education visits should be conducted with a group and should focus on a topic that is identified during a site visit or requested by site staff Regularly scheduled meetings are not considered educational visits Educational visits need to be approved prior to the visit by the MnVFC clinical coordinatorplanner in order for you to receive reimbursement from the MnVFC program
Unscheduled (Unannounced) Storage amp Handling Visit
Unscheduled (unannounced) visits are not pre-scheduled with the site These visits require different paperwork and focus primarily on the storage and handling portion of a MnVFC site visit The MnVFC program is required to visit 5 percent to 10 percent of enrolled sites as unannounced visits each year Please discuss any unscheduled visits you would like to do with the MnVFC clinical coordinatorplanner You should plan to complete all of your regularly scheduled visits before doing any unscheduled visits
Enrollment Visit
All sites (including satellite clinics) that receive stock or supply MnVFC vaccine must have an enrollment visit that is conducted by MDH staff As an IPI advisor you may be asked to attend the enrollment visit This is an opportunity for you to start your relationship with the site and help with follow-up that may be necessary for the site to receive MnVFC vaccine Newly enrolled sites are scheduled for their first regular site visit within the first year (preferably within 3 to 6 months) and then every other year
IPI Advisor Manual | February 2017 Page 9
IPI Advisors Chapter 2
Reimbursement for MnVFC Visits Local public health agencies are paid for the site visits they conduct MDH will reimburse participating agencies only after we receive all of the required paperwork Paperwork submitted with incorrect or missing information may delay the reimbursement
IPI program reimbursement is processed on a quarterly basis and is processed in the month following each quarter through an electronic transfer of money Your agencycounty IPI advisor contact will receive an email notification of the reimbursement
Reimbursement rates are updated annually and available on the Contracts and Reimbursements (www healthstatemnusdivsidepcimmunizeipicontreimhtml) page
2017 MnVFC Site Visit Reimbursement Rates MnVFC Site Visit $400 Follow-up Visit$150 Education Visit$100 Unscheduled Visit$300
Reasons MDH Would Do All or Part of a Visit MDH may complete site visits or accompany you on a site visit if
bull The site is new to the MnVFC program (enrollment visit) bull The site has known issues or concerns regarding the MnVFC program especially if you are having difficulty resolving these issues
bull The site is refusing a site visit from local public health or yoursquore having a difficult time scheduling a visit
bull The site is part of tribal health or Indian Health Services bull MDH district epidemiologists will perform site visits at local health departments bull A new IPI advisor needs training from MDH staff bull Note MDH district epidemiologists will perform site visits at local health departments
Page 10 IPI Advisor Manual | February 2017
Chapter 3 Site Visits Scheduling the Visit
bull Check the information sheet or contact the site to confirm who the contact person is in charge of the MnVFC program In general this is the immunization manager or vaccine coordinator If the contact is no longer there ask for the person in charge of the sitersquos vaccines or the clinic manager They can usually direct you to the appropriate person You may want to follow a suggested phone script when contacting the site
Sample Phone Script for Scheduling a Visit
ldquoHello My name is _______ I am calling from ________ Health Department May I speak to (contact name) [If not available determine appropriate person to talk to or a better time to call back] I am calling to schedule a MnVFC site visit This visit will involve a review of immunization practices at your site We will look at vaccine administration storage and handling screening for eligibility and documentation of vaccinations It usually takes about two hours for a visit depending on the number of vaccine storage units you have Is there a day or time of day that works best for you
I have a pre-visit worksheet to send to you to help you prepare for the visit It contains information about what I will need at the visit such as temperature logs and immunization documentation information Completing this worksheet prior to me arriving will help the visit be more efficient Is there any other information that I can send to help you prepare for the visit
If you have any questions call me at ________ Thank you for your time and assistance I look forward to working with yourdquo
bull Arrange a date and time for the visit bull Let them know an approximate visit length Visits are usually around two hours long depending on the size of the site the number of vaccine storage units they have or if they have new staff
bull Request that key staff be present at the visit This could include the immunization manager vaccine coordinator immunization staff clinic manager nurse manager billing staff andor medical director
bull Inform your site contact that you will be sending them an email confirmation along with the MnVFC
Pre-Visit Worksheet
Site Visit Checklist Use the Site Visit Checklist on IPI Advisor Site Visit Materials (wwwhealthstatemnusdivs idepcimmunizeipisvmaterialshtml) to make sure all necessary steps are covered
MINNESOTA VA C CI N ES FO R CHI LD REN PROGRAM
Site Visit Checklist Date of visit Time
Site Name PIN
Address
Contact Phone
Complete Before the visit Comments
Review the clinic list Identify and prioritize which sites you will visit
Email or call to schedule a date and time for the visit Ask for the immunization manager or vaccine coordinator
Email appointment confirmation attach Pre-visit Worksheet and provide instructions for returning it prior to the visit (sample email on website) Include length of the visit and which staff should be present
Add site visit to Outlook calendar and reserve a car (if needed)
Review temp logs and Pre-visit Worksheet
Send a reminder email 2-3 days ahead of the visit
IPI Advisor Manual | February 2017 Page 11
i i li
Site Visits Chapter 3
Information for the Visit2017 MnVFC Pre-Visit Worksheet Site name MnVFC PIN
Address
Medical director Email
Immunization manager Phone
Vaccine coordinator Phone
Vaccine coordinator back-up Email
IPI Site Vis t Preparat on Check st
The staff listed have completed the MnVFC online training and printed a certification of completion Immunization Manager Vaccine coordinator Vaccine coordinator back-up
Have a copy of the most recent provider agreement
Check if the above listed staff have changed since the provider agreement was completed
Check all of the vaccines administered at your site and list the corresponding publication date for each VIS you give to patients
DTaP _____________ Hepatitis A _____________ Hepatitis B _____________ Hib _____________ HPV _____________
Influenza _____________ MCV4 _____________ MMR _____________ MMR-V _____________ PCV13 _____________
Polio _____________ Rotavirus _____________ Tdap _____________ Varicella _____________
Non-Routine Vaccines Men B__________ PPSV23 _____________ Td _____________
Vaccine administration fee charged for MnVFC eligible children is $
Have a Vaccine Management and Emergency Plan that has been reviewed and dated within the last year
Have the borrowing reports if applicable for the last 12 months available at the visit
Have an anaphylaxis protocol that is clearly posted and reviewed annually
Send an appointment reminder email and the MnVFC Pre-Visit Worksheet to the MnVFC contact A sample letter and the MnVFC Pre-Visit Worksheet can be found on the IPI Advisor Site Visit Materials (wwwhealthstate mnusdivsidepcimmunizeipisvmaterialshtml) page You can request that the MnVFC Pre-Visit Worksheet and temperature logs be sent to you prior to the visit for your review
Contact the site by phone or email one or two working days before the scheduled visit to confirm your appointment This is also a good time to ask for directions and parking information if you are not familiar with the site
Preparing for the Visit Review the site visit paperwork to familiarize yourself with the questions For most of the questions there is a ldquoNote to the reviewerrdquo These notes give helpful tips about the information you are looking for when asking this question It contains the rationale for the question and which resources to provide to the site to support the rationale Some sections also require immediate on-site actionsmdashthings you must do while you are at the site and some require future follow up
bull Print copies the of site visit paperwork bull Site visit forms are available on the IPI Advisor Site Visit Materials (wwwhealthstatemnusdivs idepcimmunizeipisvmaterialshtml) page 2017 MnVFC Site Visit Questionnaire 2017 MnVFC Site Visit Storage amp Handling per Unit Answer Sheet (print one for each stand-alone andor combination storage unit at the site) 2017 MnVFC Provider Follow-up Plan (print two copies)
bull Review any previous site visit paperwork that is available You should check in with MDH staff after your visits if the site continues to have the same issues as past visits
bull Also be sure to bring Your thermometers If the sitersquos certificate of calibration is expired or the probe is not properly placed place your thermometer in the storage unit when you arrive and read the temperature just prior to reviewing the site visit findings
The MnVFC folder with additional immunization resources you wish to add (see chapter 5) and the Vaccine Storage amp Handling magnet (to order email healthIPIinquiriesstatemnus) A copy of the appropriate MnVFC Policies and Procedures Manual found on the MnVFC website (wwwhealthstatemnusvfc) Appropriate temperature logs (Celsius or Fahrenheit) Site information sheet that contains the quantity and value of the vaccine distributed to the sitesystem
Page 12 IPI Advisor Manual | February 2017
Site Visits Chapter 3
Conducting the Visit Education is a large part of the MnVFC site visit Often approaching this visit as an exchange of information with the site is more successful than a ldquoregulatoryrdquo visit Putting the staff at ease answering their questions and making a plan to address issues that arise during the visit is more helpful than a ldquopassfailrdquo attitude Education will usually consist of providing the rationale for the requirement referring to the requirement in the MnVFC Policies and Procedures Manual and providing resources to help address the situation Some questions will require additional follow-up to assure the site has corrected the issue(s) and is meeting the MnVFC requirement(s) This will be addressed further in the follow-up section
Completing the Paperwork
There are three documents that you must complete for the MnVFC site visit bull 2017 MnVFC Site Visit Questionnaire bull 2017 MnVFC Site Visit Storage amp Handling per Unit Answer Sheet (one for each storage unit) bull 2017 MnVFC Provider Follow-up Plan (two copies or you may ask them to make you a copy of the completed form for their records)
Answer the questions on the MnVFC Site Visit Questionnaire based on how things are when you arrive at the site If they correct the issue during the visit you will still mark it as an unmet requirement and document how it was addressed during the visit
The ldquoAnswerrdquo field will contain all the possible answer choices for this question For most questions answer choices will be followed by the markings below
bull Answer choices with no marking mean the site meets the CDC requirement bull Answer choices marked with an [X] indicate that this specific answer choice is non-compliant with a CDC requirement
bull Answer choices marked with an [O] indicate that this specific answer choice is not aligned with a CDC recommendation
If you marked the box with the [X] which is non-compliant with the CDC requirement conduct a root cause analysis to determine the reason for non-compliance Root cause analysis is an important component to a successful site visit It is used to identify the cause of the problem and help to resolve the issue There are several possible root causes that can be identified Choose only one root cause
bull Human cause Personal beliefsopinions Does not understand rationale of requirement Lack of concern for compliance
bull Organizational cause Competing job assignmentsworkload Lack of (insufficient) staff to perform required duties Budget limitations (for required equipment) Lack of (insufficient) training of staff Lack of (insufficient) processesprotocols
IPI Advisor Manual | February 2017 Page 13
Site Visits Chapter 3
Once identified the root cause should be documented in the questionnaire including a brief explanation of why you chose that cause This allows for follow-up with the site and a way to help find improvements to meet the unmet requirement Complete any immediate on-site action These often require providing education and resources for the site Mark the box for each action taken If you provide additional resources or information you can use the notes section to indicate the additional items
ldquoFuture follow-uprdquo are actions the site needs to take to meet the requirements of the program Wersquoll go over more specific information about the site visit questionnaire in Chapter 4
Performing the Site Visit
As you become familiar with the MnVFC program and develop a relationship with your sites you will develop a visit pattern that works for you Here is one possible sequence for conducting MnVFC site visits
bull When you arrive at the site if you have a business card it is helpful to provide it to the front desk staff person
bull When you meet with the immunization manager andor vaccine coordinator introduce yourself and explain the expectations for the visit
bull Ask to see the temperature monitoring device(s) It must have a current certificate of calibration and the probe must be properly placed in the unit If it does not meet the requirements place your thermometer in the unit at the beginning of the visit so that it has sufficient time to reach an accurate temperature by the time you complete your assessment of the storage units
bull 2017 MnVFC Site Visit Questionnaire Ask all of the questions You may have to modify the order of the questions based on what is best for the site When you get to the storage and handling section (section 4) use the answer sheet(s) to document the answers to the questions for each storage unit that stores vaccine (MnVFC or private) Do not write answers in the questionnaire unless there is an unmet requirement Be sure to ask if there is vaccine stored anywhere else at any time at this location This includes a co-located pharmacy If so these additional units will need to be assessed as well If the site has a combination refrigeratorfreezer household unit and is using both sections discuss with them the recommendation (and probable future requirement) to have a separate freezer Refer to MDH if they have further questions or need more information Be prepared to address any storage and handling mishaps that you may find A copy of the
Clinicianrsquos Vaccine Mishap Checklist is with your visit materials and the Emergency Response Worksheet is in the MnVFC Policy and Procedure Manual If you are unsure how to handle the problem call the MnVFC program at 651-201-5522 during or after the visit
Page 14 IPI Advisor Manual | February 2017
Site Visits Chapter 3
Ending the Visit bull Fill out the two copies of the 2017 MnVFC Provider Follow-up Plan (or ask them to make a copy once it is completed for their records) Indicate if they have not met the requirement by checking the box in the ldquoUnmetrdquo column If they are not meeting requirements check the required actions Review the plan with them reinforcing the positive things they are doing as well as reviewing the required follow-up action(s) Give the site a copy of the Provider Follow-up Plan Keep the signed copy of the Provider Follow-up Plan to submit with your paperwork Do not leave a copy of the Site Visit Questionnaire at the site
bull Let them know you will be sending a thank you email that will summarize the site visit Included in the email will be a survey link you would appreciate them completing regarding the visit
After the Visit bull Send the site a thank you email There is a template thank you letter on the IPI Advisor Site Visit Materials (wwwhealthstate mnusdivsidepcimmunizeipisvmaterialshtml) page Be sure you include the issues that you identified and the timeline for their completion as well as the good things you found at the visit In the template letter be sure to include the survey link The survey is very brief ndash a few questions and space to write comments
bull Either transfer your MnVFC Site Visit Questionnaire and MnVFC Site Visit Storage amp Handling per Unit Answer Sheet information to the fillable version or submit the handwritten form to MDH
Documentation of the Visit
Paperwork must be submitted to MDH within 10 days of the visit in order to meet the federal VFC programrsquos reporting requirements Do not wait to complete your follow-up before submitting the site visit paperwork
Send the following documents to MDH bull 2017 MnVFC Site Visit Questionnaire (includes the cover sheet) bull 2017 MnVFC Site Visit Storage amp Handling per Unit Answer Sheet (one for each unit) bull 2017 MnVFC Provider Follow-up Plan (original signed plan)
Submit site visit materials to bull Email healthIPIinquiriesstatemnus (preferred) bull Mail IPI Program Specialist
Immunization Practices Improvement Program Minnesota Department of HealthPO Box 64975St Paul MN 55164-0975
IPI Advisor Manual | February 2017 Page 15
Site Visits Chapter 3
Future follow-up Follow-up is an important component of the site visit It helps us ensure that the unmet requirements have been corrected The questionnaire has different time periods for follow-up depending on the question Do not wait to complete your follow-up before submitting the site visit paperwork
When you complete the Follow-Up Form make sure to keep a copy for yourself MDH also keeps track of follow-up required and will remind you if follow-up has not been completed by the deadline Most follow-up can be done with a phone call or email In-person follow-up is rarely required and should be discussed with MDH before scheduling a follow-up visit
All requirements that need follow-up are identified with a [X] on the site visit paperwork and are listed on the MnVFC Provider Follow-up Plan
bull Follow-up with the site to see how they have resolved the unmet requirements bull Document your follow-up on the Follow-Up Form available on the IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml) page If follow-up was done via letter or email a copy can be attached to the Follow-Up Form
bull Send your Follow-Up Form to MDH (healthIPIinquiriesstatemnus) with supporting documents and emails
bull If a site is not responding to your requests regarding follow-up contact your MnVFC clinical coordinatorplanner They can help with additional follow-up as needed
Page 16 IPI Advisor Manual | February 2017
Chapter 4 The 2017 MnVFC Site Visit Paperwork This chapter will go through the required MnVFC site visit paperwork with notes about information or resources to help the site address questions or issues that may arise during the visit
The MnVFC site visit paperwork is available on the IPI Advisor Site Visit Materials (wwwhealthstate mnusdivsidepcimmunizeipisvmaterialshtml) page
Please download the paperwork shortly before your visit as there may be updates and changes and this will be the most up-to-date version of the questionnaire We will send out a Workspace message with major changes
Required Paperwork for Site Visits bull 2017 MnVFC Site Visit Questionnaire bull 2017 MnVFC Storage amp Handling Per Unit Answer Sheet ndash one for each unit assessed during site
visit bull 2017 MnVFC Provider Follow-up Plan ndash with provider signature
Make sure to include the sitersquos PIN on all your paperwork Please complete and submit your site visit paperwork as soon as possible after your visit It may be helpful to schedule some time into your calendar to complete your paperwork in the days following your visit Once you have completed the post-visit follow-up send in the Follow-Up Form with documentation of the follow-up actions Please do not wait until you have completed your follow-up before sending in your initial paperwork
MnVFC Site Visit Questionnaire The questionnaire includes these six sections 1 Provider details 2 Eligibility 3 Documentation 4 Storage amp handling per unit 5 Storage amp handling site-wide 6 Inventory
IPI Advisor Manual | February 2017 Page 17
Page 18 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
The Site Visit Reviewer Legend The legend explains the formatting of the 2017 questionnaire This includes information that will be helpful in completing the site visit
Site Visit Reviewer Guide Legend
Section Number Content Area
Question number This area will always contain the text of the question
Note to reviewer The note to reviewer contains information that is necessary for properly asking and assessing responses tothe question above This may include definitions of terms requirement details and other helpful tips
Answers This field will contain all the possible answer choices for this question For most questions answer choiceswill be followed by the markings below
Answer choices marked with an [X] indicate that this specific answer choice is non-compliant with a CDC requirement Answer choices marked with an [O] indicate that this specific answer choice is not aligned with a CDC
recommendation
Review CDC RequirementRecommendation
This field will be populated with the CDC requirementrecommendation associated with the given question
Actions if Non-Compliant
Root Cause Analysis As part of the site visit reviewers are required to assess and understand the reasons why a provider office isnon-compliant with VFC program requirements ndash this is a root cause analysis Reviewers must choose theone root cause that they believe most contributes to the non-compliance Upon establishing the root causethe reviewer must provide a clear explanation of hisher findings
Immediate Action These are actions that CDC requires reviewers to take on site during the visit
Future Follow-up These are future follow-up actions (with designated due dates) that are required of the reviewer andorprovider to remedy non-compliance Reviewers must complete all follow-up in accordance with CDCestablished deadlines
Notes Information you want the VFC program to be aware of or that explains your answer in detail
bull Note to reviewer These are notes to help you understand what the question is asking for and to clarify things you might want to know when asking or rephrasing the question
bull Answers This section helps you to know when the answer does not meet the CDC requirement [X] or recommendation [O] Whenever an answer with a [X] is checked the ldquoActions if Non-compliant section must be completed The recommendations are usually good teaching points about best practices andor future requirements of the VFC program
bull Review the CDC RequirementRecommendation This section provides a specific outline of the requirement or recommendation to give you information to use in talking with the site staff
bull Actions if Non-Compliant This section describes what to do if the site is not meeting a requirement Root cause analysis This section asks you to probe beyond the surface to find what is driving the non-compliance It is intended to help uncover reasons for recurring non-compliance issues identify additional training needs and inform reviewer follow-up actions Select only one root cause and explain the particular circumstances in the space ldquoExplanation of root causerdquo line provided If there appear to be multiple issues choose the one that most contributes to the non-compliance and describe all factors in the explanation Immediate actions A list of actions to take during the site visit to address the issue Future follow-up A list of actions to take after the site visit by the set deadline
bull Notes This section can be used for notes to yourself or to MDH
IPI Advisor Manual | February 2017 Page 19
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 1 Provider Details Questionnaire Coversheet
The first page of the questionnaire collects the demographic information for the site You can use this page to help prepare for the visit Most of the demographic information about the site should be on the site-specific document you received with your clinic list You will validate that this information is current at the time of the site visit It also helps to know if this is a separate stock site or a replacement site before the visit so you can bring a copy of the appropriate MnVFC Policies and Procedure Manual
2017 MnVFC Site Visit Questionnaire Date of visit _____________ Date forms sent to MDH ______________
Site Information
Site name MnVFC PIN
Address Separate Stock Replacement
City ZIP County
Medical Director Email
Immunization Manager Phone
Vaccine Coordinator Phone
Vaccine Coordinator back-up Email
Point of contact Phone
Personnel at site visit
On this page bull The date of the visit and the date when you send these forms to MDH This information helps us track the timeliness of our review and data entry process
bull The vaccine management method used by the site (replacement or separate stock) bull The name and email of the medical director (ideally this is the person who signed the MnVFC
Program Provider Agreement)bull Contact information for the immunization manager vaccine coordinator vaccine coordinator back-up and point-of-contact for this visit The immunization manager vaccine coordinator vaccine coordinator back-up roles are
described in the MnVFC Policies and Procedure Manual The vaccine coordinator back-up may be the immunization manager or another staff person depending on the size of the site and available personnel The Point of Contact is the person you set up the appointment with signs the Provider Follow-
up Plan and receives the follow-up email This may be one of the people listed above
The Post Visit Steps section is a reminder to you about what needs to done after the visit The Education on Immunization Best Practices for Sites section reminds you to provide the resource folder to the site
Page 20 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 12
1 Provider Details Changes to Key Staff
Question 12 Ask the provider about changes to key staff to answer the questions below
A (Choose all that
apply)
At the time of the visit is the Medical Director the same individual that signed the ProviderAgreement and are the Immunization Manager and Vaccine Coordinator the same asthose last reported to the program
Yes No the Medical Director has changed No the Immunization Manager has changed No the Vaccine Coordinator has changed
B (Choose one)
Were all changes communicated to theImmunization Program according to yourprogramrsquos policy
Yes or no staff changes No [X]
C (Choose one)
Based on review of the trainingdocumentation have the current Immunization Manager Vaccine Coordinator and back-up completed all required training
Yes No [X]
Review CDC Requirement
All changes in key staff must be communicated to the Immunization Program in the manner and timeframe defined by theImmunization Program Key staff include the Medical Director or equivalent who signed the Provider Agreement the Immunization Manager Vaccine Coordinator and the back-up VFC providers are required to ensure that all key staff are fully trained on VFC program requirements at all times All training must be documented
Goal of this question Determine if there are new staff in key positions at the site and to make sure staff are properly educated about the MnVFC program A This information can help you determine the level of knowledge and experience the staff have with the MnVFC program Follow-up throughout the visit can be tailored for various levels of staff experience Likewise you may identify additional training needs for new staff
B When sites notify us of changes in key personnel we update their information in MIIC and on the clinic lists We also send the new staff information for completing the online training and direct them to read the appropriate MnVFC Policies and Procedures Manual If the answer to this part is no update the demographic area of the questionnaire and inform the staff that in the future they must notify the MnVFC program (via email or phone) if the immunization manager or vaccine coordinator changes Resource Section 12 of the MnVFC Policies and Procedures Manual
C Annual training must be verified by looking at the certificates for the online training If the answer to this part is no refer the staff to complete the appropriate MnVFC online training found on the MnVFC website (wwwhealthstatemnusvfc) for their program (separate stockreplacement) for the current year and send you a copy of the certificate within 30 days
Resource bull Sections 12 and 14 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 21
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 2 Eligibility Question 21
Goal of this Question Assess whether staff correctly understand which patients are eligible for the MnVFC program Screening ensures that eligible children receive the vaccines that they are entitled to receive under the MnVFC program and helps to prevent fraud or abuse of the program
Children 18 years and younger in these
categories can receive MnVFC vaccine at any enrolled site bull Uninsured bull Enrolled in a Minnesota Health Care Program (MHCP) Medical Assistance (MA) or MinnesotaCare bull American Indian or Alaskan Native
The following categories are considered underinsured and are only MnVFC-eligible at local public health (LPH) Federally Qualified Health Centers (FQHC) Rural Health Centers (RHC) Indian Health Services (IHS) and tribal health clinics
bull Has health insurance that does not cover one or more vaccines as can be the case with newly licensed vaccines that arenrsquot yet covered (MnVFC-eligible for non-covered vaccines only)
bull Has health insurance that caps vaccine coverage at a certain amount Once that amount is reached the child is MnVFC-eligible
Children with insurance that does not cover vaccines until a deductible has been met are considered to be fully insured and are not MnVFC-eligible
Helpful information bull Sites are not required to verify the patientrsquos response to the screening questions For example if a patient states they lost their insurance the site does not need to call the patientrsquos insurance company to confirm
If the site cannot correctly describe the eligibility categories provide educational materialsresources on MnVFC eligibility requirements
Resources bull Patient Eligibility Screening Record on MnVFC Forms (wwwhealthstatemnusdivsidepc immunizemnvfcformshtml)
bull Section 1 of the MnVFC Policies and Procedures Manual
2 Eligibility VFC Eligibility Categories
Question 21 Was the individual responsible for determining patient VFC eligibility able to explain all the factors(including age) that make a child eligible to receive VFC vaccines
A Patient is less than 19 years of age Yes No [X]
B Patient is Medicaid-eligible Yes No [X]
C Patient is uninsured Yes No [X]
D Patient is underinsured Yes No [X]
E Patient is American Indian Yes No [X]
F Patient is Alaska Native Yes No [X]
Review CDC Requirement
VFC providers must possess a working knowledge of all VFC eligibility criteria and use those criteria to screen children prior toadministering VFC vaccines In order to receive VFC vaccine a patient must be under the age of 19 and must be at least one of the following (1) Medicaid-eligible (2) Uninsured (ie child has no health insurance) (3) Underinsured (ie child has health insurancebut coverage does not cover any or certain vaccines ndash underinsured children may only receive VFC vaccines in FQHCRHC ordeputized VFC provider offices and only for vaccines not covered by insurance) and (4) American Indian or Alaska Native (AIAN)
Page 22 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 22
2 Eligibility Billing Practices
Question 22 Is the individualdepartment responsible for billing able to clearly explain how they bill for both the costof vaccine and the vaccine administration fee for each of the eligibility categories below
A Medicaid-eligible Cost of Vaccine Do not bill ndash provided by VFC Admin Fee Bill Medicaid
Yes No [X]
B Uninsured Cost of Vaccine Do not bill ndash provided by VFC Admin Fee If billing can bill patient
Yes No [X]
C Underinsured Cost of Vaccine Do not bill ndash provided by VFC through FQHCsRHCs or deputized providers only all other providers cannotprovide VFC vaccine to underinsured patients Admin Fee If billing can bill patient
Yes No [X]
D American IndianAlaska Native(AIAN)
Cost of Vaccine Do not bill - provided by VFC unless patient is fully insured and parent chooses to use insurance Admin Fee If patient is Medicaid-eligible bill Medicaid if billingand patient is uninsuredunderinsured can bill patient if parentchooses to use private insurance for cost of vaccine billpatientinsurance
Yes No [X]
E Do individuals responsible for billing have access to the results of eligibility screening toensure proper billing
Yes No [X]
Review CDC Requirement
VFC providers must adhere to proper billing practices for vaccine administration fees and clearly understand that VFC vaccine isprovided at no cost to both the VFC provider and eligible children At no time should billing occur for the cost of VFC vaccine Whenadministering VFC vaccine providers should never bill two different ldquopayersrdquo (ie patient Medicaid insurance) for the samevaccine administration fee amount For Medicaid-eligible children Medicaid should be billed for the vaccine administration fee Forall other VFC-eligible populations the patient may be billed within the stateterritory cap established by the Centers for Medicareand Medicaid (CMS) However patients cannot be turned away or reported to collections for inability to pay the administration fee
Goal of this question Determine if the staff correctly understand how to bill patients that are eligible for the MnVFC program Billing appropriately ensures that children can receive low cost immunizations and the site is in compliance with the VFC program
bull If there is any indication that sites could be billing insurance companies or parents for VFC vaccines this should be investigated further
bull Most sites in Minnesota will bill Medicaid with the SL modifier ndash which indicates this is a Medicaid claim
bull The main point is to ensure the site is not billing uninsured children for VFC vaccine and are not charging them more than $2122 per vaccine for the administration fee
bull Non-compliance is usually unintentional and may be resolved with some training In rare cases it could be a glimpse into a larger problem where a site is intentionally billing for financial gain
bull If you think the site is billing inappropriately it is the responsibility of the IPI advisor to report concerns to MDH staff for further assistance
Resources bull Immunization Billing Guidance for MnVFC (wwwhealthstatemnusdivsidepcimmunizemnvfc billingtipshtml) or Immunization Billing Guidance for MnVFC Replacement Method Sites (www healthstatemnusdivsidepcimmunizemnvfcreplacementbillingtipsrephtml)
bull Section 2 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 23
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 232 Eligibility Vaccine Administration Fee
Question 23 Document the actual vaccine administration fee charged to non-Medicaid VFC-eligible patients (confirmwith billing department)
Answers Fee $ [X] Follow-up is required if the provider charges more than the fee cap establishedby the Centers for Medicare and Medicaid (CMS) for your stateterritory ($2122)
Review CDC Requirement
The VFC providerrsquos vaccine administration fee for non-Medicaid VFC-eligible children must not exceed the stateterritory vaccineadministration fee cap established by the Centers for Medicare and Medicaid (CMS) For current fee caps refer to Medicaid Program Payments for Services Furnished by Certain Primary Care Physicians and Charges for Vaccine Administration Under theVaccines for Children Program Final Rule (httpwwwgpogovfdsyspkgFR-2012-11-06pdf2012-26507pdf)
Goal of this question Ensure that sites are not charging more than the federal allowable vaccine administration fee of $2122
bull The Centers for Medicaid and Medicare (CMS) establishes a maximum fee that sites can charge to non-Medicaid-eligible VFC patients in each stateterritory for vaccine administration Health Plans usually negotiate this fee with the site but Medicaid will not pay more
bull If a parent cannot pay the vaccine administration fee the patient cannot be turned away or reported to collections VFC-eligible children must be vaccinated regardless of their ability to pay
bull If the person with whom you are conducting the site visit does not know the exact fee charged to non-Medicaid VFC-eligible patients ask to speak to someone who can verify the exact amount
bull If they are charging more than $2122 for the administration fee ndash please contact MDH staff for help with addressing this situation
Resources bull Immunization Billing Guidance for MnVFC (wwwhealthstatemnusdivsidepcimmunizemnvfc billingtipshtml) or Immunization Billing Guidance for MnVFC Replacement Method Sites (www healthstatemnusdivsidepcimmunizemnvfcreplacementbillingtipsrephtml)
bull Section 2 of the MnVFC Policies and Procedures Manual
Page 24 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 3 Documentation Question 31
3 Documentation Eligibility Screening amp Documentation
Question 31 To answer the questions below the provider must clearly demonstrate the patient intake processReview a minimum of 10 records that contain an immunization visit within the last 6 ndash 12 months
Note to Reviewer Criteria for Record Selection 1) Record selection must be completely random and the provider must not know prior to the visit which
records will be reviewed 2) Patient must have been 0-19 years of age at the last visit (Note Records of 19-year-old patients may
allow you to see if VFC vaccines are being used beyond the allowable age) 3) Must review a mix of public and private-pay patients (if applicable)
A Does the provider have a process that ensures that patients are screened forVFC eligibility at each visit and that screening results are documented at each visit
Yes No [X] (If no skip question F)
B Does the providerrsquos process ensure that staff administering vaccine know which vaccine stock to select from prior to drawing the vaccine
Yes No [X]
C Number of records reviewed If fewer than 10 records are reviewed select the reason why Provider does not have 10 patient records with immunizations in last 12 months
D Do all records contain date of the immunization visit and patientrsquos date of birth Yes No [X]
E Do all records contain the patientrsquos specific eligibility status associated with thedate of the immunization
Yes No [X]
F Do any of the providerrsquos records contain any evidence that the patient received vaccine for which they were not eligible
Yes [X] No
Review CDC Requirement
VFC providers must screen for and document VFC eligibility at each immunization visit Documentation must include the date of the visit and the childrsquos specific eligibility category VFC providers must use screening results to ensure that only VFC-eligible children receive VFC vaccine and that administration fees are billed for as appropriate Eligibility status must be readily available to staff administering vaccine prior to selecting which vaccine stock to use
Goal of this question Ensure the site is screening for eligibility and documenting the eligibility category in the medical record
Review a minimum of 10 records from within the last 6-12 months where the patient received an immunization You must review a mix of public and private pay patients (if applicable)
Random selection is important If the staff have pre-selected records for review do not use and identify additional randomly selected records to review
Helpful information bull Discuss upgrading the electronic health record to make documentation of VFC eligibility screening a required field Documenting eligibility screening in the immunization field promotes better MIIC data
bull Q 31 B Sites using the replacement method of vaccine management only have one stock so you will answer ldquoYesrdquo to this question
Resources bull Patient Eligibility Screening Record on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfcformshtml)
bull Section 1 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 25
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 32
3 Documentation Vaccine Dose Documentation
Question 32 Review a minimum of 10 patient immunization records from the last six months (or 12 months ifnecessary) to assess compliance with documentation requirements set forth by Statute 42 US Code 300aa-25 (See note to reviewer below)
Note to Reviewer Criteria for Record Selection 1) Record selection must be completely random the Provider must not know prior to the visit which records
will be reviewed 2) Patient must have been 0-19 years of age at the last visit (Note Records of 19-year-old patients may allow
you to see if VFC vaccines are being used beyond the allowable age)
Records are Compliant if they Contain ALL the Below Elements
bull Address of clinic where vaccine was administered bull Publication date of VIS bull Name of vaccine administered bull Name of vaccine manufacturer bull Date vaccine was administered bull Lot number bull Date VIS was given bull Name and title of person who administered the
vaccine
A Number of records reviewed
B Number of records that contain ALL required documentation elements
If fewer than 10 records are reviewed select the reason why Provider does not have 10 patient records with immunizations in last 12 months
[X] Follow-up isrequired if one ormore records do not meet requirements
Goal of this question Assess whether the site is documenting all required information in each patientrsquos medical record for every vaccine dose administered in accordance with the National Childhood Vaccine Injury Act
Resources bull Section 6 of the MnVFC Policies and Procedures Manual bull National Vaccine Injury Compensation Program (wwwhrsagovvaccinecompensation)
Question 33
3 Documentation Record Retention
Question 33 Is the provider able to demonstrate (preferred) or clearly describe how they maintain historical VFCeligibility documentation for three years
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers are required to maintain all records related to the VFC program for a minimum of three years (or longer if requiredby state law) and upon request make these records available for review VFC records include but are not limited to VFC screening and eligibility documentation billing records medical records that verify receipt of vaccine vaccine ordering records and vaccinepurchase and accountability records
Goal of this question Make sure the site understands they are required to keep all MnVFC screening documentation for at least three years either electronically or on paper This information should be available to you at the time of the visit and future visits
Resource bull Section 7 of the MnVFC Policies and Procedures Manual
Page 26 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 34
3 Documentation Borrowing Documentation
Question 34 Discuss borrowing practices with the provider to answer the questions below
Note to Reviewer bull To be considered ldquofully documentedrdquo documentation for each borrowed dose must include thefollowing information
Vaccine type borrowed Date the dose was administered Stock used (VFC or private) Reason appropriate vaccine stock was not used Patient name and date of birth Date dose was returned to appropriate stock
A Did the provider state that they had borrowed any vaccines (whetherdocumented or not) since the last VFC Compliance Site Visit
Yes No (If no skip to question 36)
B Are there any doses for which there is no documentation (ie provider hasindicated that doses were borrowed but cannot verify how many or why)
All doses are documented Some doses are not documented [X] No doses are documented [X] (if nodoses documented skip toquestion 36)
C Were all borrowed doses fully documented (See Note to Reviewer above) Yes No [X]
D Were all borrowed VFC doses either replaced or an order submitted to replacethe doses Yes No [X]
Review CDC Requirement
VFC providers are expected to maintain an adequate inventory of vaccine for VFC and non-VFC-eligible patients It is theresponsibility of the VFC provider to appropriately schedule and place vaccine orders VFC providers must also rotate stock to ensure timely use of short-dated vaccines Borrowing of vaccine between private and public inventories must be a rare unplanned occurrence and cannot serve as a replacement system for a VFC providerrsquos privately purchased vaccine inventory All instances ofborrowing must be properly documented reported and replaced
Goal of this question Assess vaccine accountability by verifying that children are receiving vaccine from the appropriate stock
Borrowing is when a fully insured child receives a dose of MnVFC vaccine or a MnVFC-eligible child receives a dose of private vaccine This should be a rare unplanned occurrence The site must document any borrowing of vaccine between stocks ideally on the VFC Borrowing Report Form If they are not currently using the form review it with them and encourage them to post it close to their vaccines It does not need to be sent to MDH but should be kept for 3 years and filed with their MnVFC documents to be reviewed whenever they have a regular or unscheduled (unannounced) site visit
Helpful information bull Understand and report on staffrsquos verbal (ie anecdotal) accounts of borrowing obtained during the visit Often sites do not know that what they do is considered borrowing or they think borrowing is acceptable and documentation isnrsquot needed so long as those vaccines are eventually replaced
bull Since sites using the replacement method only have one stock of vaccine they very rarely borrow bull This question asks for future follow-up in 6 months Make a note on your calendar and ask them to send you a copy of their borrowing reports for the previous 6 months with documentation of doses borrowed and replaced We will remind you if we donrsquot hear from you at the 6 month time frame Complete the Follow-up Form and attach the borrowing form
Resources bull Vaccine Borrowing Report on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfc formshtml)
bull Section 10 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 27
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 353 Documentation Borrowing Reasons
Question 35 Based on your discussion with the provider and a review of borrowing reports document the dosesborrowed for each reason and answer the questions below
Note to Reviewer bull Short-dated vaccines are doses that are likely to expire before they can be used bull Exchanging short-dated vaccines should only occur in practices that have a small number of private
patients
A Reasons for Borrowing a VFC Dose (Enter the number of _____ Private vaccine shipment delay (order placed on time but delay in shippingreceipt)
vaccine doses borrowed for each
reason in the spaces
_____ Private vaccine not useable on arrival (vials broken temperature monitor out of range) _____ Ran out of private vaccine between orders (provider orders not placed on time) [X]
provided) _____ Short-dated private dose was exchanged with VFC stock _____ Accidental use of VFC dose for a private patient (human error) _____ Replacement of private dose with VFC when insurance plan did not cover vaccine _____ OtherDocumented dose did not include reason for borrowing [X]
(Explanation Required) Reasons for Borrowing a Private Dose _____ VFC vaccine shipment delay (order placed on time but delay in shippingreceipt) _____ VFC vaccine not useable on arrival (vials broken temperature monitor out of range) _____ Ran out of VFC stock between orders (provider orders not placed on time) [X] _____ Short-dated VFC vaccine dose was exchanged with private dose _____ Accidental use of a private dose for a VFC-eligible patient (human error) _____ OtherDocumented dose did not include reason for borrowing [X]
(Explanation Required)
B Enter date range for instances of borrowing reviewed in the borrowing report Note If ldquoDate of earliest instancerdquo is not available use the date of the last VFC Compliance Visit If ldquoDate of last instancerdquo is not available use the date of thecurrent VFC Compliance Visit
Date of earliest instance
Date of last instance
C Does borrowing appear to be a routine practice Note To determine whether borrowing is a routine practice assess frequency of and repeating reasons for borrowing Examples Frequent accidental use of incorrect stock exchanging short-dated vaccines or issues with ordering and shipment
Yes [X] No
Goal of this question Determine the reasons why the site is borrowing vaccine
If sites are using the Vaccine Borrowing Report review the reasons for borrowing to help document borrowed VFC andor private doses If they have not been documenting borrowing on this report (or any other form) estimate their borrowing practices If you do not know the date range for their borrowing use the last site visit date to the current visit date The use of ldquootherrdquo as the reported reason for borrowing should be rare if ever and would require explanation and follow up
Helpful information bull Look to see if they routinely maintain insufficient amounts or types of vaccine to support their public and private patients that leads to borrowing
bull Pay attention to borrowing cases documented as ldquoaccidentalrdquo Repetitive accidental borrowing may indicate an issue with ordering processes or insufficient staff training
bull Borrowing is not a place to document wasted or lost doses bull The time period of the borrowing may give you clues about the root cause Were the borrowed doses concentrated in a short period or spread out across several months or a year Are all vaccine types being borrowed or just one
bull If borrowing seems to be an issue discuss vaccine management ordering procedures
Resources bull Vaccine Borrowing Report on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfc formshtml)
bull Section 10 in the MnVFC Policies and Procedures Manual
Page 28 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 36
3 Documentation Vaccine Management Plan
Question 36 Physically review the providerrsquos Vaccine Management Plan to answer the question below
A Does the provider have a Vaccine Management Plan Yes No [X] (If no skip to question 37)
B Does the plan list the current Immunization Manager Vaccine Coordinator andback-up
Yes No [X]
C Does the plan address proper vaccine storage and handling practices Yes No [X]
D Does the plan specify vaccine receiving procedures Yes No [X]
E Does the plan contain procedures for what to do with vaccine in the event of an emergency
Yes No [X]
F Does the plan contain procedures for vaccine ordering Yes No [X]
G Does the plan address inventory control (example stock rotation) Yes No [X]
H Does the plan address how to handle vaccine wastage Yes No [X]
I Does the plan address staff training and documentation on vaccine managementstorage amp handling
Yes No [X]
J Does the plan contain a review date that falls within the last 12 months Yes No [X]
K Has the plan been signed by the individual responsible for its content Yes No [X]
Review CDC Requirement
VFC providers must develop maintain and implement a Vaccine Management Plan for routine and emergency vaccinemanagement The plan must contain the current Vaccine Coordinator and back-up proper storage and handling practicesshipping and receiving procedures emergency procedures procedures for vaccine ordering inventory control (eg stock rotation)how to handle vaccine wastage and staff trainingdocumentation on vaccine management storage and handling The plan must bereviewedupdated annually or more frequently if changes occur A ldquoreview daterdquo and signature are required on all plans in order tovalidate that they are current
Goal of this question Evaluate the sitersquos plan for vaccine management It is especially important that they have a plan for emergency management of their vaccine in the case of equipment failure or power outage Encourage all sites to read and sign the MnVFC Policies and Procedures Manual and complete the emergency plan or be able to show you a plan of their own
If the provider is not able to physically show you the plan at the time of the visit or if the recorded review date is not within the last 12 months you must mark that this requirement is unmet The Vaccine Management Plan is important in times of emergency and it should be easy to access by any staff member at any time Encourage them to post the plan and put a copy with the packing supplies
Helpful information bull Encourage the site to fill in the ldquoImmunization Managerrdquo and ldquoVaccine Coordinatorrdquo fields in the
MnVFC Policies and Procedures Manual for their own referencebull The emergency plan in the manual can be reviewed from last year and included in this yearrsquos manual (with an updated signature and date) if there have not been any changes
bull If information in the plan is outdated site staff will not be well equipped to safely manage vaccines in the event of a power-outage or other emergency situation
bull If their institutional policy is only reviewed and updated every 3-4 years (as many are) the staff may need to sign the MnVFC Polices and Procedure Manual to meet this requirement
Resource Routine Vaccine Management Plan and Emergency Vaccine Management Plan in the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 29
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 37
3 Documentation VIS amp VAERS
Question 37 Review the providerrsquos Vaccine Information Statements (VISs) and discuss providerrsquos VAERS process toanswer the questions below
A Does the provider have readily available up-to-date VISs for all ACIP-recommendedvaccines relevant to the populations it serves
Yes No [X]
B Does the provider make a VIS available for patientsparents before eachvaccination
Yes No [X]
C Does the provider know how and when to report clinically significant adverseevents using VAERS
Yes No [X]
Review CDC Requirement
VFC providers are required to distribute the current Vaccine Information Statements (VIS) each time a vaccine is administered and maintain records in accordance with the National Childhood Vaccine Injury Act (NCVIA) which includes reporting clinicallysignificant adverse events to the Vaccine Adverse Event Reporting System (VAERS) For a list of current VISs visit CDCrsquos Vaccine Information Statements (httpwwwcdcgovvaccineshcpvis) website
Gal of this question Ensure the site has the most current VISs and is giving them to each patientparent before administering the vaccine in compliance with the federal law Parents must be educated about the vaccine their child will receive and be aware of possible contraindications and side-effects in order to make well-informed decisions about their childrsquos health
Helpful information bull Ask to see the sitersquos VISs to determine if they have an active protocol for giving VISs to parents Review to make sure they are current Ask if they know where and how to report vaccine adverse events
Resources bull Section 3 in the MnVFC Policies and Procedures Manual bull CDC Vaccine Information Statements (wwwcdcgovvaccineshcpvisindexhtml) Site may sign up for email updates for the current list of VIS publication dates for the most up-to-date version
bull IAC Itrsquos Federal Law You must give your patients current Vaccine Information Statements (wwwimmunizeorgcatgdp2027pdf)
bull VAERS (httpsvaershhsgovindex)
Question 38
3 Documentation Anaphylaxis protocol
Question 38 Does the site have an anaphylaxis protocol which is clearly posted near the emergency kit
Answers (Choose one)
Yes No [X]
Review CDC Requirement
An anaphylaxis protocol must be clearly posted in the area where vaccines are administered
Goal of this question Make sure site is prepared for a severe allergic or anaphylactic reaction to a vaccine
Resources bull Section 11 in the MnVFC Policies and Procedures Manual bull IAC protocols Child and Teens (wwwimmunizeorgcatgdp3082apdf) and Adults (wwwimmunize orgcatgdp3082pdf)
Page 30 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
i
i i i - li i i i i i l
Section 4 Storage amp Handling Per Unit The goal of this section is to assess vaccine storage
2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet practices in each unit at the site MnVFC PIN ___________________
The 2017 MnVFC Storage amp Handling Per Unit Answer Sheet is a worksheet to document the answers to the questions in this section for each unit (combination or stand-alone) Fill in the answers to the questions in Section 4 on the answer sheet not in the questionnaire
The answer sheet has an abbreviated form of each question If you need further information on that question refer back to the full questionnaire Also if you find an area where the site is not meeting the requirements you will need to go back to that question on the 2017 MnVFC Site Visit Questionnaire to complete ldquoActions if Non- compliantrdquo section including the root cause analysis and follow-up sections If there is a problem in more than one unit make a note on the questionnaire which unit you are referring to in the Notes section
Important You must fully assess any unit that may be used to store VFC vaccines even if there are no VFC vaccines there on the day of the visit If there are no vaccines and the site is not documenting twice a day temperatures discuss the need to ensure the unit is maintaining stable temperatures by monitoring for one week before placing vaccines in the unit
Quest on number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
for the freezer and e co umn
Temperature Monitoring Dev refr gerator f the un
ce Quest ons Quest ons 4 3 4 7 must be answered separate y t s a combo Be sure to document responses n the appropr at
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
44D Data downloaded and reviewed routinely (eg weekly)
Yes No [O]
Yes No [O]
45A Certificate of Calibration Testing Yes No [X]
Yes No [X]
45B Date of calibration
45C Date certificate expires [X] Follow-up is required if expired [X] Follow-up is required if expired
45D Certificate contains all necessary items
Yes No [X]
Yes No [X]
46 Probe properly placed Yes No [X]
Yes No [X]
47A Two temperature readings per day
Yes No [X]
Yes No [X]
47B Time date and name (or initials) for each reading
Yes No [X]
Yes No [X]
47C Current temperature and minmax temperatures (if
Current ________deg Minimum ________deg Maximum _deg
Current ________deg Minimum ________deg Maximum _deg
Sections 5 and 6 contain questions about storage and handling site wide and inventory It is helpful to keep those questions in mind as you assess the individual storage units Think about dorm-style units expired vaccine vaccine supply room for vaccine stocking all the recommended vaccines and separation of stock if appropriate
NOTE The sections that follow require reviewers to validate responses by looking at vaccine storage units temperaturemonitoring equipment and the vaccine inventory inside a unit bull For section 4 use a separate Storage amp Handling Per Unit Answer Sheet for each unit to document the findings (combination
units using both sections can be documented on the same answer sheet) bull When an unmet requirement is identified return to this questionnaire to complete the ldquoActions if Non-compliantrdquo section for
that question bull After you complete one answer sheet for each unit return to the questionnaire to complete sections 5 and 6 using information
you gathered while assessing the units The questions in sections 5 and 6 (Storage amp Handling Site-Wide and Inventory) are notunit-specific but do require that the response be based on a thorough assessment of all the providersrsquo units
4 Storage amp Handling Per Unit
Description On the Storage amp Handling Per Unit Answer Sheet place a name that will allow you or someone else from your program to easily identify this unit in the event of follow-up We recommend using Brand + Location(example Samsung - Room 123) Save each Storage amp Handling Per Unit Answer Sheet with the Brand + Location in the file name
(example SamsungRoom123doc)
IPI Advisor Manual | February 2017 Page 31
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 41
4 Storage amp Handling Per Unit Storage Unit Build amp Use
Question 41 Below select the build and use of the vaccine storage unit you are assessing
Note to Reviewer Dorm-style units Do not add dorm-style units here Dorm-style units will be addressed in section 5 Units storing only private stock You must review these storage units even if they contain only private stockat the time of the visit because that vaccine could be administered to VFC patients
A What type of unit is this A Stand-alone B Combination
B Select use if stand-alone A Freezer B Refrigerator
Select use if combination A Use both sections to store vaccine B Use freezer section only to store vaccine C Use refrigerator section only to store vaccine
Goal of this question Identify the unit you are evaluating The description asks you to create a unique name for this unit so that you will be able to identify the same unit in future site visits Put this description on the top of the answer sheet (ie make and location)
Helpful information bull A stand-alone unit is either a refrigerator or a freezer It does not have both sections in the unit bull If there is a combination unit note if the site uses both the refrigerator and freezer or only one section of the unit to store vaccines CDC does not recommend the use of either section or the freezer section only of combination household units
bull If your site utilizes the separate stock method of vaccine management you must review storage units even if they contain only private stock at the time of the visit because there is a chance that those vaccines could be administered (borrowed) to VFC-eligible patients
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The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 424 Storage amp Handling Per Unit CDC Recommended Storage Units
Question 42 Below document the grade of the vaccine storage unit you are assessing
Note to Reviewer Pharmaceutical Also called ldquopurpose-builtrdquo these units are designed by the manufacturer specifically tostore vaccines or other biological materials Commercial Although usually intended to store food and beverages commercial units are often larger and more powerful than the household units found in most homes Though these units are intended to meet thehigher demands of larger facilities these units are not specifically built for the storage of biologicalmaterials Household (non-commercialdomestic) These units are usually smaller than commercial units and areintended for use in small offices and in homes ndash typically for food storage However just like commercialunits they are not designed specifically for the storage of biological materials Such units are usually available in common home supply stores
Answers (Choose one)
Select grade A Pharmaceutical B CommercialHousehold
[O] CDC does not recommend the use of both sections or the freezer section only of combination commercialhousehold units
Review CDC Recommendation
CDC recommends the following vaccine storage unit types (in order of preference) pharmaceutical grade stand-alone orcombination units (preferred) householdcommercial stand-alone units householdcommercial combination units using therefrigerator section only
Goal of this question Assess the grade and type of each storage unit bull Pharmaceutical grade units may be stand-alone or combination units that are often metal may have glass in the door for viewing inside often have an external digital temperature display and are manufactured by medical companies
bull Commercial or household units often look like your kitchen appliance have vegetablemeat drawers in the unit and are manufactured by household appliance companies
bull Occasionally you might find a medical grade unit which is usually a commercialhousehold unit with a lock and 3-prong plug These are still considered household units because of their ability to maintain proper temperatures and air flow Studies show that household stand-alone units are better able to maintain consistent temperatures than their combination counterparts Combination household units used to store vaccine in both sections of the unit is no longer recommended and may be prohibited in the future Combination household storage units that are having difficulty maintaining a cold enough freezer temperature and a warm enough refrigerator temperature should be replaced or a separate stand-alone freezer should be purchased
For frozen vaccines the most cost effective solution is for the site to purchase a small stand-alone freezer The site may need time to budget for a stand-alone storage unit
Resources bull Replacing Combination Household Units Tip Sheet on IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml)
IPI Advisor Manual | February 2017 Page 33
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 434 Storage amp Handling Per Unit Temperature Monitoring Device in the Unit
Question 43 Determine whether there is a temperature monitoring device in this section of the storage unit andanswer the questions
A Is there a temperature monitoring device in this section of thestorage unit
Yes No [X] (If no skip to question 47)
B Who is responsible for supplying the temperature monitoring device in this section of the storage unit Provider
Review CDC Requirement
Certificates of calibration testing provide confidence that the temperature monitoring device is measuring temperaturesaccurately All units storing VFC vaccines must have a calibrated temperature monitoring device with a current and valid certificateof calibration testing All certificates must contain modeldevice name or number serial number date of calibration testing (report or issue date) and Instrument Passed testingInstrument in Tolerance (Recommended uncertainty = +-05ordm C (+-1ordm F))
Goal of this question Assess whether there is a temperature monitoring device in the unit If the unit is not being monitored at all call MDH at 651-201-5522 for guidance
Helpful information bull This question does not ask whether the temperature monitoring device is working or the characteristics of the device These issues will be addressed later in the questionnaire
bull For part B the provider is always responsible for supplying the temperature monitoring device Even if their thermometer or data logger was originally from MDH it is their responsibility to ensure it is functional and calibrated
Resources bull Section 8 in the MnVFC Policies and Procedures Manual
Page 34 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 444 Storage amp Handling Per Unit CDC Recommended Temperature Monitoring Device
Question 44 Assess the temperature monitoring device in this section of the storage unit to answer the questionsbelow
A Is the temperature monitoring device a continuous monitoring and recordingdevice (eg data logger)
Yes No [O] (Skip D)
B Does the temperature monitoring device have a probe in buffered material Yes No [O]
C Does the temperature monitoring device have a digital display that can beeasily read from the outside of this unit
Yes No [O]
D Is data downloaded and reviewed routinely Yes No [O]
Review CDC Recommendation
As of Jan 1 2018 all VFC providers must use continuous temperature monitoring devices (eg data loggers) to monitor vaccinesthat will be administered to VFC-eligible children Routine review and accessibility of temperature data is critical for determining whether vaccine has been properly stored and for assessing usability of vaccine that was involved in a temperature excursion Tomeet VFC Program requirements the device must also be equipped with bull A temperature probe bull An active temperature display that can be easily read from the outside of the unit bull The capacity for continuous monitoring and recording capabilities where the data can be routinely downloaded
The following are additional recommended features for these devices bull Alarm for out-of-range temperatures bull Current minimum and maximum temperatures display bull Low battery indicator bull Accuracy of +- 1degF (05degC) bull Memory storage of at least 4000 readings bull User programmable logging interval (or reading rate) recommended at a maximum time interval of every 30 minutes bull Use of a probe that best reflects the temperature of the vaccine (such as a buffered probe)
Goal of this question Assess the temperature monitoring device in the storage unit Note that these are all recommendations not requirements at this time
This is a great teaching opportunity for sites who do not currently have a continuous temperature monitoring device Beginning Jan 1 2018 all units that store MnVFC vaccine will be required to have a continuous temperature monitoring device (ie a data logger or a continuous temperature monitoring system) Unlike a minmax thermometer a continuous temperature monitoring device provides detailed information on all temperatures recorded at pre-set intervals For excursions it can provide information on when a temperature went out-of-range for how long and what the temperatures were This is essential information that vaccine manufacturers need to know to assess the viability of the vaccine following an excursion
Helpful information bull Sites are required to monitor and record temperatures twice daily however temperature excursions can easily occur in the 12 hours or longer between readings Continuous temperature monitoring can help manufacturers determine vaccine viability
bull Continue to encourage sites to document and evaluate minimum and maximum temperatures the storage unit reached since the last reading and respond appropriately to out-of-range temperatures
IPI Advisor Manual | February 2017 Page 35
The 2017 MnVFC Site Visit Paperwork Chapter 4
bull It is recommended that sites download and review data weekly Discuss with sites that reviewing temperature monitoring device data also includes responding appropriately if they identify out-of-range temps
bull There is sometimes confusion about the difference between a data logger and a continuous temperature monitoring system Here are some differences
Data Loggers Continuous Monitoring Systems Have an external display similar to thermometers May or may not have an external display Have a detachable probe Probe is usually attached to transmitter Need to be plugged into the computer or cradle to download information on a regular schedule
Wirelessly sends data to computer system
Create a file of data that needs to be saved on the computer
Data is stored within the system not a separate file
Doesnrsquot allow documentation of twice a day temperature checks in the file
May allow documentation of twice a day temperature checks within the system
More about the 2018 requirement for a continuous temperature monitoring device
Required Features bull The continuous temperature monitoring device must have Continuous monitoring and recording capabilities to track and record temperatures over time The capacity to routinely download temperature data to a computer (recommended at least weekly) or wirelessly transmit data Detachable probe in a bottle filled with a thermal buffer (eg bio-safe glycol) if the data logger needs to be detached in order to download data Active temperature display
Recommended Features bull MnVFC recommends continuous temperature monitoring devices with Alarm for out-of-range temperatures Accuracy within +-1degF (+- 05degC) Low battery indicator Display of current minimum and maximum temperatures Memory storage of at least 4000 readings User programmable logging intervals (eg the user can set how often the device records the temperature)
Note that these are all currently recommendations not requirements yet
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Page 36 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 45
Goal of this question Ensure the temperature monitoring device is properly calibrated The certificate of calibration testing means that the device has been tested and it is accurately measuring temperatures within established testing limits The certificate of calibration ensures that the device meets all the required components
Helpful information bull The provider is always responsible for having a current certificate of calibration (or copy) on-site
bull To be considered ldquovalidrdquo a certificate of calibration must contain these required elements Modeldevice name or number Serial number
4 Storage amp Handling Per Unit Certificate of Calibration Testing
Review CDC Requirement
Certificates of calibration testing provide confidence that the temperature monitoring device is measuring temperaturesaccurately All units storing VFC vaccines must have a calibrated temperature monitoring device with a current and valid certificateof calibration testing All certificates must contain modeldevice name or number serial number date of calibration testing (report or issue date) and Instrument Passed testingInstrument in Tolerance (Recommended uncertainty = +-05ordm C (+-1ordm F))
Question 45
Note to Reviewer
A
B
C
D
E
Review the certificate of calibration testing for the temperature monitoring device in this section of the storage unit and answer the questions below
bull How to determine certificate of calibration testing expiration date 1) Identify the certificate issuecalibration date 2) Apply the Immunization Program-required frequency for calibration testing Example If the
issuecalibration date is 12312013 and Immunization Program policy requires testing every twoyears the expiration date is 12312015
bull Certificates must include all of the below bull ModelDevice Name or Number bull Serial Number bull Date of Calibration Testing (Report or Issue Date) bull Instrument Passed testing (Instrument in Tolerance)
Is there a certificate of calibration testing for the temperature monitoring Yes device in this section of the storage unit No [X]
What is the date of calibration for the temperature monitoring device in this section of the storage unit
What is the certificatersquos date of expiration based on ImmunizationProgram policy (See note to reviewer to determine expiration date) [X] Follow-up is required if
certificate is expired
Does the certificate contain all the necessary items listed in the Note to Yes Reviewer No [X]
Who is responsible for supplying the current and valid certificate of Provider calibration for this temperature monitoring device
Date of calibration testing (report or issue date) Note If there is no expiration date the certificate expires 2 years from the date of calibration Whether the instrument passed or failed testing (or instrument in tolerancenot in tolerance)
bull Recommended element Documented uncertainty of +- 1degF [05degC]
If these elements are present the certificate is considered valid If the certificate contains information about the recommended element or the entity that issued the certificate that is helpful but not required
To determine if a certificate of calibration testing was issued by an appropriate entity check to see if the certificate indicates one or more of these items (this is the wording used to help sites evaluate if their calibration is accurate but is not required on the certificate itself to be considered valid)
bull Conforms to ISO 17025 bull Performed by an ILACMRA Signatory body accredited laboratory You can review this list of the ILAC MRA and Signatories (httpilacorgilac-mra-and-signatories)
bull Traceable to the standards maintained by NIST bull Meets specifications and testing requirements for the American Society for Testing and Materials (ASTM) Standard E2877 tolerance Class F (le 05 degC) or better
bull Includes reference to another acceptable accuracy validation method such as comparison to other traceable reference standards or tests at thermometric fixed points
Note CDC recommends that certifications be issued for the entire monitoring unit (detachable probe data logger etc) and not individual certificates for each component
IPI Advisor Manual | February 2017 Page 37
The 2017 MnVFC Site Visit Paperwork Chapter 4
For 45 E the provider is always responsible for supplying the current and valid certificate of calibration for a temperature monitoring device
bull Tip If the temperature monitoring device has a sticker on the back with the calibration date the site can usually call the company who calibrated the device and get a copy of the certificate if they donrsquot have one
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 46 4 Storage amp Handling Per Unit Probe Placement
Question 46 Is the probe properly placed in this section of the storage unit
Note to Reviewer ldquoProperlyrdquo means that the probe in a commercial or household unit is placed in a central area of the unitdirectly with the vaccines Probes should not be placed in the doors near or against the walls close to vents or on the floor of the unit The only allowable exemption related to this requirement is for providerswho have pharmaceutical storage units (built for vaccine storage) that have either (1) a built-intemperature monitoring device OR (2) a dedicated port for the probe that dictates the placement of theprobe
Answers (Choose one)
Yes No [X]
Review CDC Requirement
The probe must be placed in a central area of the section of the storage unit directly with the vaccines in order to properly measurevaccine temperature The probe should not be placed in the door near or against the walls close to vents or on the floor of theunit For pharmaceutical units with a built-in temperature monitoring device or a dedicated port for a probe that is not in thecenter of the section of the storage unit consult your Immunization Program for guidance on placement
Goal of this question Make sure the temperature monitoring device is in the best location to accurately measure the temperature of the vaccines stored in the unit
Helpful information bull The probe of the temperature monitoring device should be placed directly with the vaccines in the middle of the unit The ONLY allowable exception is for pharmaceutical storage units that have either a built-in thermometer or a dedicated port for the probe that indicates placement of the probe
bull Temperatures can vary within the unit especially household units bull Call MDH at 651-201-5522 if you have questions
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Guide (wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml)
Page 38 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 474 Storage amp Handling Per Unit Temperature Documentation
Question 47 Review the temperature documentation over the past three months for this section of the storage unit todetermine whether the provider has a process in place for properly documenting temperatures twice aday Answer the questions below
A Are there two temperature readings recorded for this section of the storage unit per day
Yes No [X]
B Is there a time date and name (or initials) recorded for each reading Yes No [X]
C What is the current temperature and minmax temperatures (if available) inthis section of the storage unit Use the reviewerrsquos thermometer if the providerrsquos temperature monitoringdevice does not have a current valid certificate of calibration testing or the probe is not properly placed in this section of the storage unit
Current Temperature Minimum Temperature Maximum Temperature Fahrenheit Celsius
D Based on your review of the providerrsquos recent temperature documentationincluding the current temperature is this section of the storage unitmaintaining appropriate temperatures
Yes No [X] Not enough information [X]
Review CDC Requirement
Vaccines must be stored under appropriate temperatures as described in the package inserts at all times Acceptable temperature ranges vary by vaccine type and the range is 36deg F and 46deg F (2deg C and 8deg C) and for frozen vaccines the range is -58deg F and +5deg F (shy50deg C and -15deg C) Exposure to temperatures outside of those included in the package inserts could affect vaccine viability andultimately could leave children unprotected against vaccine-preventable diseases In order to maintain awareness of storage unittemperatures and ensure that vaccines are being stored at appropriate temperatures at all times VFC providers are required to monitor and document temperatures for all vaccine storage units at least twice a day Temperature documentation must contain (1) at least two temperature readings per day (2) the time and date of each reading and (3) the name (or initials) of the personwho assessed and recorded the readings CDC also recommends that VFC providers record the minimum and maximumtemperatures of each unit once each workday (preferably in the morning)
Goal of this question Ensure the temperature is being monitored twice daily is within the required range and documented correctly Use your thermometer to check the temperature if the sitersquos temperature monitoring devicersquos probe is not properly placed or there is not a current certificate of calibration Place your thermometer in the unit at the beginning of the visit to allow sufficient time to reach an accurate temperature The purpose of using your thermometer is to ensure the vaccine is being stored at the proper temperature not to ldquovalidaterdquo their reading
Question 47 D is an assessment question based on information you have learned during your visit You might answer ldquonot enough informationrdquo if the unit is new and they donrsquot have at least three months of data or if the unit is only used as overflow and they are inconsistent with temperature monitoring Mark ldquoNordquo if you have reason to believe the storage unit is not maintaining temperatures properly
Helpful information bull All sites must document temperatures twice a day every day the site is open even if they have a data logger or continuous monitoring system
bull Sites can document the information electronically with some continuous monitoring systems as long as it can show what the current temp is the date time and initials of the person checking ndash this needs to be someone at the site ndash not checking remotely or centrally for a large site or system The site must be able to produce these records during their site visit Reviewing these files can be a challenge due to large volumes and lots of paper
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Temperature Logs on Managing Vaccine (wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml)
IPI Advisor Manual | February 2017 Page 39
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 484 Storage amp Handling Per Unit Temperature Excursions
Question 48 In the event that a temperature excursion(s) occurred in this unit within the last three months requestand review documentation of actions taken to determine whether the provider has a process for properlyaddressing excursions Answer the questions below
A Were vaccines in this unit exposed to out-of-range temperatures in the lastthree months (including today)
Yes No (If no skip to question 49)
B Did the provider quarantine and label vaccines as ldquoDo not userdquo Yes No [X]
C Did the provider place vaccine in a unit where it can be stored under properconditions if applicable
Yes No [X]
D Did the provider contact the Immunization Program to report theexcursion
Yes No [X]
E Was the manufacturer contacted for documentation supporting theusability of the vaccine
Yes No [X]
Review CDC Requirement
The provider must document all excursions and actions taken including the following (1) Quarantine and label vaccines as ldquoDO NOTUSErdquo (2) Place vaccines in a unit where they can be stored under proper conditions (3) Contact the Immunization Program to report an excursion and (4) Contact the vaccine manufacturer to obtain documentation supporting the usability of the vaccine
Goal of this question Address any out-of-range temperatures (temperature excursions) identified in reviewing the last three months of temperature logs or during the site visit If there were any out-of-range temperatures did the site respond appropriately to the situation This is a great opportunity to discuss what to do in the event of an excursion The Clinicians Storage and Handling Mishap Checklist is in the IPI Site Visit information folder and is a good review of the process
Helpful information bull Sites need to know that an excursion does not automatically mean that exposed vaccines are non-viable or unusable Exposed vaccines must be quarantined (marked ldquoDo Not Userdquo) and stored under proper conditions until they have received information from vaccine manufacturers regarding the viability of the vaccine
bull Sites must inform MDH when an excursion occurs
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Clinicians Storage and Handling Mishap Checklist (wwwhealthstatemnusdivsidepcimmunize ipivaxchklstpdf)
Page 40 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 49
Goal of this question Ensure proper placement of vaccines in the storage unit
Note These are all recommendations (best practices) not requirements
Helpful information bull Store vaccine in the middle of the compartment two to three inches away from the coils walls floor and cold air vent The temperature near the floor and walls of the unit differs from that in the middle of the compartment and the cold air vent can freeze refrigerated vaccines
4 Storage amp Handling Per Unit Vaccine Placement
Question 49 Look inside the unit to answer the questions below
A Are vaccines placed in the middle of the unit with space between vaccinesand the sideback of the unit to allow cold air to circulate
Yes No [O]
B Are vaccines stored in their original packages Yes No [O]
C Are there water bottles (for refrigerators) or frozen water bottles (forfreezers) in the unit
Yes No [O]
D Are vaccines store in the doors vegetable bins under or near cooling ventsor on the floor of the unit
Yes [O] No
E Is food being stored in the unit Yes [O] No
Review CDC Recommendation
Vaccines should be stored in their original manufacturer (or CDC centralized distributor) packaging They should be placed in the middle of the unit with space between the vaccines and the sideback of the unit to allow cold air to circulate Vaccines SHOULD NOT be stored in the doors vegetable bins or floor of the unit or under or near cooling vents and there should not be any food inthe unit Water bottles (for refrigerators) or frozen water bottles (for freezers) should be placed throughout each storage unit inorder to (1) stabilize or extend temperatures during a power outage and (2) to serve as physical blocks preventing the placementof vaccines in areas of the unit that are at higher risk for temperature excursions (such as in doors vegetable bins floor ornearunder cooling vents)
bull Vaccines should be kept in their original packaging to Protect them from light Help prevent medication errors by making labels easier to read Provide a moisture barrier that serves as insulation in case of an out-of-range temperature power outage door left open or mechanical failure Simplify managing vaccine inventory
bull Store water bottles in the doors on the floor and near the cold air vent in the refrigerator and frozen water bottles in the freezer to help maintain a stable temperature if there is a power failure and when the door is opened frequently Too many water bottles in the door can prevent the door from closing tightly Mark water bottles ldquoDo Not Drinkrdquo
bull Do not store vaccine in the door or drawers of the refrigerator or freezer Vegetable bins and crisper drawers should be removed from refrigerators or used to store other medical supplies or water bottles
bull If vaccine is stored in a household combination refrigeratorfreezer The top shelf should not be used for storing vaccine because the cold air vent blowing from the freezer will freeze vaccine located there If you must use the top shelf of this type of unit place water bottles underneath the cold air vent to prevent vaccine from being stored there It is recommended that only the refrigerator be used for vaccine storage and a separate stand-alone freezer be used to store frozen vaccine
bull Must not store food or beverages in the refrigerator or freezer because frequent opening of doors can lead to temperature variations that may affect vaccine viability There is also a risk of contaminating vaccines
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Guide (wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml) bull Vaccine Storage Tip Sheet on IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml)
IPI Advisor Manual | February 2017 Page 41
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 4104 Storage amp Handling Per Unit Disconnection from Power Source
Question 410 Ask the provider to demonstrate what measures are taken to ensure that vaccine storage units are notaccidentally physically disconnected from the power supply Which of the following describes the measure(s) taken on this unit
Note to Reviewer bull Large hospitals and healthcare systems may not have the ability to demonstrate labels on plugs or circuitbreakers In such cases verify that the practice has a comprehensive policy and standard operatingprocedures in place to prevent the vaccine storage unit from being physically disconnected from thepower supply
bull While back-up generators may ensure power to the overall facility this question ONLY addresses thevaccine storage unit being accidentally disconnected from the power source either through the plug orthe circuit breaker
Answers A ldquoDo not disconnectrdquo labels on the plug (Choose all that B ldquoWarningrdquo label on the circuit breaker box
apply) C Hard-wired (ie built-in) and has a ldquoDo not disconnectrdquo label on thecircuit breaker box D Hospital or large health care system with a comprehensive written policyand standard operating procedures detailing measures taken to preventvaccine storage units from being accidentally disconnected from the powersupply E No acceptable measures for preventing accidental disconnection frompower supply [X]
[X] The response is non-compliant if only A only B or E is selected
Review CDC Requirement
VFC providers must take steps to protect the power source for all vaccine storage equipment by means of having clear warninglabels on both the plug and the circuit breaker associated with all vaccine storage units Large hospitals and healthcare systems canmeet this requirement by demonstrating that they have comprehensive policies and standard operating procedures to preventvaccine storage units from being physically disconnected from the power supply
Goal of this question Decrease the chance that a vaccine storage unit will be accidently unplugged or power will be turned off while vaccine is in the unit This question addresses only what measures the site has taken to ensure the storage unit is not physically disconnected from its power source
If the site uses labels on the plugs and circuit breakers perform a visual inspection to assess whether the way the stickers are positioned make it clear and obvious to anyone that these units are not to be disconnected
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Do Not Unplug and Warning stickers are included in the folder or available to order on the For
Professionals Order Form (wwwhealthstatemnusdivsidepcimmunizeordermathtml)
Note Once you have completed the 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet for each unit return to the questionnaire to complete sections 5 and 6
Page 42 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
- -
Section 5 Storage amp Handling Site-Wide Question 51
5 Storage amp Handling Site Wide Discussion of Cost amp Quantity of Vaccine
Question 51 Have a discussion with the provider about the cost and quantity of VFC vaccines they are responsible for annually Address the points listed in the note to reviewer below
Note to Reviewer bull Vaccine Shipped (Required) Share the cost of VFC vaccines shipped to the provider in the last calendaryear to make sure the provider understands the contribution made by the VFC Program to their practiceFor new providers who do not have ldquocalendar yearrdquo data share either the actual cost of their currentinventory or use the cost of 10 VFC doses of each of the ACIP-recommended vaccines (approximately $7000) to help estimate their annual cost
bull Storage amp Handling (Required) Make sure the provider understands the cost of vaccines for which they are responsible when they make decisions about purchasing recommended vaccine storage and temperature monitoring equipment
Answer I have discussed with the provider the cost and quantity of vaccines ordered in the previous calendar year
Goal of this question Inform sites of the quantity and value of vaccines that they receive as part of the MnVFC program Providers often donrsquot realize the value of the vaccine in their unit This information is included on your clinic list and on the one page site-specific information
Helpful information bull This discussion must occur and the box on the questionnaire must be checked bull If there isnrsquot actual vaccine value information available tell the site that one vaccine order that includes a box of each of the ACIP recommended vaccines costs approximately $7000
bull MDH may not have specific information for individual sites if they receive vaccine from a central warehouse or pharmacy For those sites MDH will give you numbers for the whole system so you can discuss system wide data as appropriate If individual site information is also included it is usually just varicella-containing vaccines that must be shipped directly to the site
Question 52
5 Storage amp Handling Site Wide Dorm Style Units
Question 52 Determine whether the provider has any dorm-style units on site and answer the questions below
Note to Reviewer A dormitory-style refrigerator is a unit that has both refrigerator and freezer compartments behind a singleexterior door Dorm-style units also have an evaporator plate (cooling coil) which is usually located insidean icemaker compartment (freezer) within the refrigerator
A Does the provider have any dorm-style units that are used at any time tostore vaccines
Yes [X] No (Skip to question 53)
B Does the provider have sufficient space in existing compliant vaccinestorage units to store all vaccines without use of the dorm-style unit at any time
Yes No [X]
Review CDC Requirement
Dorm- and bar-style units are prohibited for vaccine storage Vaccines stored in dorm-style units are considered non-viable and must be returned to the centralized distributor CDC recommends the following vaccine storage unit types (in order of preference)pharmaceutical grade stand-alone or combination units (preferred) householdcommercial stand-alone unitshouseholdcommercial combination units using the refrigerator section only
Goal of this question Ensure no vaccine is stored in dorm-style units even for short periods of time Encourage them to label any units ldquoNo Vaccine Storage Allowedrdquo Vaccine stored in these units is considered non-viable If a site is using a dorm-style unit call the MnVFC program (651-201-5522)
Resource Section 8 in the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 43
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 535 Storage amp Handling Site Wide Storage Unit Space Availability
Question 53 Does the provider have sufficient room across storage units to store current stock as well as anyadditional stock acquired during peak season without overcrowding
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have sufficient storage space to accommodate vaccine stock at the busiest time of year without overcrowding
Goal of this question Ensure that sites have sufficient space in their units to maintain vaccines at the busiest time of year Overcrowding of vaccine limits air circulation and affects the unitrsquos ability to maintain stable temperatures
Helpful information bull Look for signs of overcrowding such as vaccines that are pushed up against the wall bins that are overflowing or storage units that are full during non-peak seasons
Discuss immediate actions if the unit is overcrowded Move some of their vaccines order less vaccine more frequently (once per month preferably) andor purchase another storage unit for overflow
Resource bull Section 8 MnVFC Policy and Procedure Manual
Page 44 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 545 Storage amp Handling Site Wide Expired Vaccines
Question 54 Look in each unit Are there expired vaccines in any of the vaccine storage units at this site
Answers (Choose one)
Yes [X] No
Review CDC Requirement
Vaccines should be rotated weekly and when a new shipment comes in so that longer-dated vaccines are stored behind shorter-dated vaccines If vaccines expire they can no longer be stored in the same storage unit with viable vaccines They must be placedin a container or bag clearly labeled ldquoDo not userdquo and separated from viable vaccines to prevent inadvertent use Expired vaccinemust be returned to the centralized distributor within six months of expiration
Goal of this question Ensure there is no expired vaccine in any storage unit
Helpful information bull Sites can prevent their stock from expiring by rotating vaccines every week andor when a new shipment arrives Longer-dated vaccines are stored towards the back of the unit and shorter-dated vaccines are up front
bull Pay attention to vaccines that expire within the next three months Consider transferring vaccine that will expire soon to another MnVFC-enrolled site that will use the vaccine preferably a site close by It is the transferring sitersquos responsibility to arrange the transfer of the vaccine Be sure to complete the MDH Vaccine Transfer Record form and send it to MDH If they are having difficulty finding a location to accept vaccine contact MDH
bull This is a great opportunity to educate sites about the MDH Nonviable Vaccine Form and the process for returning vaccine The VFC program does get some credit for taxes and fees on vaccine that is returned to the distribution center
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MDH Nonviable Vaccine Form and MDH Vaccine Transfer Record on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfcformshtml)
IPI Advisor Manual | February 2017 Page 45
The 2017 MnVFC Site Visit Paperwork Chapter 4
- -
-
Question 555 Storage amp Handling Site Wide Back up Thermometer
Question 55 Does the provider have a readily available back-up thermometer with a current and valid certificate ofcalibration testing
Note to Reviewer ldquoReadily availablerdquo means that the thermometer is available to perform twice-a-day monitoring for a unit asrequired CDC recommends that the back-up thermometer be maintained on site
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have a readily available back-up thermometer with a current and valid certificate of calibration testing Toprevent the certificates of calibration testing of the primary and back-up thermometers from expiring at the same time the date of calibration testing (or issue date) of the back-up thermometer should be different from the date of calibration testing (or issue date) of the primary thermometer As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meetsVFC program requirements
Goal of this question Ensure sites have one calibrated back-up thermometer onsite that is readily available in the event that the temperature monitoring device in unit fails transportation of vaccine is needed or there are other unexpected circumstances
Helpful information bull As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meets VFC Program requirements
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 56 5 Storage amp Handling Site Wide Preparation of Vaccine
Question 56 When does this provider prepare vaccine for administration to the patient
Note to Reviewer For mass vaccination clinics if one type of vaccine is offered providers may pre-draw up to 10 doses Ifusing pre-filled syringes pre-drawing also means activating the syringe by removing the needle guard orattaching a needle
Answers (Choose all that
apply)
Prepare dose immediately before administration Pre-draw doses for upcoming patients (in a regular clinicpractice) [O] Pre-draw up to 10 doses (in a mass-vaccination clinic) Pre-draw more than 10 doses (in a mass-vaccination clinic) [O] Other [O]
Review CDC Recommendation
CDC recommends preparing vaccines immediately prior to administration in order to assure viability of vaccine and prevent vaccinewastage Vaccines that are not administered immediately are at risk of exposure to temperatures outside of the required rangewhich can affect vaccine viability and ultimately can leave children unprotected against vaccine-preventable diseases
Goal of this question Discuss proper timing and preparation of vaccine(s) for administration These are recommendations not requirements
Helpful information bull Educate staff on the importance of preparing vaccine immediately before administration Pre-drawing of vaccines may lead to concerns related to vaccine viability potency sterility and wastage
Page 46 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 6 Inventory Question 61
6 Inventory Inventory Comparison
Question 61 Visually inspect storage units to determine if existing supply of vaccines proportionately mirrorspopulations served Choose the most accurate statement below
Note to Reviewer bull CDC recommends that providers maintain a four-week supply of inventory bull For this question do not take into account vaccine types that the provider does not order Here simply
make sure that overall the vaccines in the providerrsquos storage units are available in sufficient amounts toserve their patient population
Answers (Choose one)
The current vaccine inventory proportionately reflects the populations identified Only public stock is insufficient [X] Only private stock is insufficient [X] Both public and private stock are insufficient [X] Site uses the replacement method but does not appear to have enough vaccine for their population [X] Other [X]
Review CDC Requirement
VFC providers must order and stock routine vaccines in accordance with their patient population in order to prevent missedvaccination opportunities Having sufficient amounts of all stocks prevents the inadvertent use of VFC vaccines for non-VFC-eligiblepatients and vice versa
Goal of this question Assess whether the site is ordering appropriate quantities of vaccine for the population they serve at their site
Helpful information bull If the site sees 30 percent private-pay patients and 70 percent VFC the stock in their storage units should reflect that proportion If you donrsquot know you can ask the site about their population
bull This is meant to be a general assessment so in a big site if they have only a small amount of vaccine that may indicate an issue with vaccine management
bull CDC recommends smaller more frequent orders (ie monthly) rather than large orders to minimize the amount of vaccine loss if an incident occurs during shipment or in the storage unit Sites should not order more frequently than once a month
bull Sites using the replacement method will only have one stock but it should appear to be large enough for their population
bull Only assess the vaccine types that the site currently stocks in their unit We know there are sites that do not offer all ACIP-recommended vaccines for various reasons That issue will be addressed in question 62
IPI Advisor Manual | February 2017 Page 47
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 626 Inventory ACIP Recommended Vaccines
Question 62 Review providerrsquos current inventory to answer the questions below
A Does the provider offer all routine ACIP-recommendedvaccines for their patient population
Yes (Skip to question C) No [X] Offers all except varicella because direct ship ofvaccine is unavailable from manufacturer
B Which routine vaccines are NOT being offered DTaP Hepatitis A Hepatitis B HIB HPV Influenza Meningococcal
MMR Pneumococcal Polio Rotavirus TdapTd Varicella
C According to Immunization Program Policy does theprovider make accessible all non-routine ACIP-recommended vaccines for those VFC patients whomeet the criteria for receiving them
Yes (Skip to question 63) No [X]
D Which non-routine vaccines are NOT being offered Pneumococcal polysaccharide vaccine (PPSV23) Meningococcal Group B (MenB) Other
Review CDC Requirement
VFC providers agree to comply with immunization schedules dosages and contraindications that are established by the Advisory Committee on Immunization Practices (ACIP) for the vaccines identified and agreed upon in the Provider Agreement UNLESS bull In the VFC providers medical judgment and in accordance with accepted medical practice the VFC provider deems such
compliance to be medically inappropriate for the child bull The particular requirements contradict state law including laws pertaining to religious and other exemptions The VFC program entitles children to the following vaccines DTaP Hepatitis A Hepatitis B HIB HPV Influenza MeningococcalMMR Pneumococcal Polio Rotavirus TdapTd and Varicella VFC providers are also required to ensure that VFC-eligible children have access to non-routine vaccines as needed
Goal of this question Assess if the site is offering all the ACIP-recommended vaccines for the population they serve and these vaccines are in stock on the day of the visit It is important that every MnVFC-eligible child that comes to a providerrsquos office for an immunization is vaccinated
Helpful information bull The Advisory Committee on Immunization Practices (ACIP) is a group of medical and public health experts that develops recommendations on how to use vaccines to control diseases in the United States
bull Specialty providers are not required to offer all routine vaccines but should provide the vaccines appropriate for their population
bull If the site does not offer all routine ACIP-recommended vaccines appropriate for their population check the ldquoNordquo box in Part A then check the appropriate box(es) in Part B for any vaccines not offered Please contact MDH as this situation offers us the opportunity to provide education to the site
bull For non-routine vaccines they must either be in stock or the site must have an alternative protocol in the routine management plan that ensures these children have access when applicable
Resources bull IAC Diseases and Vaccines (wwwimmunizeorgvaccines) bull CDC Advisory Committee on Immunization Practices (ACIP) (wwwcdcgovvaccinesacipindexhtml)
Page 48 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 636 Inventory Separation of Stock
Question 63 Observe how the provider differentiates stock in each storage unit to answer the questions below
A Is it clear which vaccines belong to public stock andwhich belong to private stock
Yes No [X] Not applicable replacement site
B Is it clear which vaccines belong to VFC stock andwhich belong to UUAV stock
Yes No [X] Not applicable replacement site Not applicable not UUAV-enrolled site
Review CDC Requirement
In order to ensure that VFC vaccines are only administered to VFC-eligible children VFC providers that serve both VFC and non-VFCshyeligible children must maintain their vaccine inventories in such a way that they can clearly differentiate public stock from privatestock as well as VFC from other public stock
Goal of this question Assess whether the site can distinguish between MnVFC vaccine and private vaccine If they participate in the Uninsured and Underinsured Adult Vaccine (UUAV) program they should also be able to distinguish between MnVFC stock and UUAV stock Some sites use labels bins boxes etc to differentiate their stock If it is not clear how the site differentiates their stock discuss vaccine management with the staff For follow-up call MDH to discuss doing a follow-up site visit
Sites using the replacement method will not have separate stocksmdashthis is an approved alternative method for keeping track of vaccine
Resource bull Section 10 of the MnVFC Policy and Procedure Manual
IPI Advisor Manual | February 2017 Page 49
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
MnVFC Site Visit Storage and Handling Per Unit Answer Sheet 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet MnVFC PIN ___________________
Question number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
Temperature Monitoring Device Questions Questions 43 47 must be answered separately for the freezer and refrigerator if the unit is a combo Be sure to document responses in the appropriate column
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
All the questions on the Site Visit Storage amp Handling Per Unit Answer Sheet have been discussed previously in section 4 of this manual Use this sheet to record information about all the units at the site visit You will need one sheet for each unit If it is a combination unit (either pharmaceutical or household) you can record both sections on one sheet If they have stand-alone units use one sheet for each unit Do not enter the answers to the questions in section 4 of the questionnaire
If you need more information about any of the questions refer back to the main questionnairemdashthe complete question additional guidance including notes to the reviewer and the CDC requirements are there Also if the site is not meeting the requirement you will go back to the questionnaire to complete the ldquoActions if Non-compliantrdquo section including the root cause analysis and follow-up sections
When you have completed the assessment of all the storage units remember to go back to the questionnaire to complete sections 5 and 6
Page 50 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
ndash
ndash
MnVFC Provider Follow-up PlanThe goal of the Provider Follow-up Plan is to communicate with the site all of the VFC requirements any unmet requirements found during your site visit and the timeline for completing the required action The left hand column is a box to check for ldquoUnmetrdquo requirements
Helpful information bull The form can be used to review what the site is doing well and what they need to work on
bull For requirements that have specific documentation that needs to be sent to you use the notes section
2017 MnVFC Provider Follow-up Plan Site _______________________________________________ MnVFC PIN ____________ Date of Visit ___________
Thank you for participating in this MnVFC compliance site visit Please review this visit summary including follow-up actions and timelines for completion Unmet MnVFC requirements and recommendations have a checked box next to them The goal of this plan is to support you with successfully implementing the program and improving access to vaccines for VFC-eligible children
Unmet Question VFC Requirements Section 1 Changes to Key Staff
Q12 Change in the Medical Director Immunization Manager Vaccine Coordinator or back-upKey Staff must be communicated to the immunization program by emailing healthmnvfcstatemnus Changes Notes
Q12 Key staff must complete the annual training on VFC program requirements and print theAnnual Training certificate of completion Documentation Required Action
Staff that have not completed the MnVFC online training must complete it and send acopy of the certificate to the reviewer Training can be found on the MnVFC website (wwwhealthstatemnusvfc) Due date 1 month
Notes
Unmet Question VFC Requirements Section 2 Eligibility
Q21 Provider staff must possess a working knowledge of all VFC eligibility criteria and use thoseVFC Eligibility criteria to screen children prior to administering VFC vaccines
Categories Notes
bull This form provides documentation needed for follow-up actions when you send your thank you email
The second to last page of the Provider Follow-up Plan has a summary of the MnVFC program recommendations These are to remind the site about best practices they may want to improve upon even though they are not yet requirements of the program For example you could discuss the recommendation about storage units if they currently have a combination household unit and are using both sections
The last section is for your signature and the person you met with In most sites it will be the immunization manager or vaccine coordinator who signs the form unless the medical director attended the site visit You keep the original copy and the site will need to keep a copy for themselves
To be completed by the site visit reviewer
I acknowledge that a VFC site visit was performed on __________________ (visit date) The follow-up plan which includes a list of all current VFC program requirements and recommendations assessed during the visit and any required follow-up actions was provided at the end of the visit
Site visit reviewer
Phone
Reviewer Signature Date
To be completed by the provider
I acknowledge that our practice took part in the VFC site visit noted above I understand the findings of the visit and any required actions that must be taken by our office in order to meet VFC program requirements
Medical Director (or designee) Name Title
Medical Director (or designee) Signature Date
IPI Advisor Manual | February 2017 Page 51
The 2017 MnVFC Site Visit Paperwork Chapter 4
After the Site Visit Send a thank you email highlighting the unmet requirements documents you need from the site to resolve the issue(s) and the date you need them Make sure to include the link to the Site Visit Survey (httpssurveyvovicicomseashxs=56206EE334CE0B14)
Please refer to Chapter 3 for more information about future follow-up required after the visit including forms and documentation
Resource bull Sample Thank You letter on IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml)
Chapter 5
IPI Advisor Resource List MnVFC Program 651-201-5522
MnVFC wwwhealthstatemnusvfc
bull Separate Stock and Replacement Method Policies and Procedures Manuals bull Online trainings bull MnVFC Announcements sign up to receive them via email bull Ordering MDH vaccine bull MnVFC forms Screening forms Reporting forms Others MDH Nonviable Vaccine Form MDH Vaccine Transfer Record and Vaccine Borrowing Report
bull MnVFC promotional materials bull Immunization Billing Guidance for MnVFC and Immunization Billing Guidance for MnVFC Replacement Sites Immunization Practices Improvement Program (IPI) wwwhealthstatemnusdivsidepcimmunizeipi
bull IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml) bull IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml) IPI Resource Folder Contents (wwwhealthstatemnusdivsidepcimmunizeipiipifolderpdf)
Minnesota Immunization Information Connection (MIIC) wwwhealthstatemnusmiic
bull MIIC regions and regional coordinators
Clinical Practice MDH Immunization Program wwwhealthstatemnusimmunize
Got Your Shots News wwwhealthstatemnusdivsidepcnewslettersgys
MDH Immunization Information for Health Care Providers wwwhealthstatemnusdivsidepcimmunizehcp
bull Got Your Shots A Providers Guide to Immunization in Minnesota bull Vaccine protocols bull Forms for tracking patient immunizations bull Immunization schedules for Health Care Providers Immunization Action Coalition (IAC) wwwimmunizeorg
bull Ask the Experts bull VISs (Vaccine Information Statements and translations) bull Administration screening questions bull Medical management of vaccine reactions bull Order form for Californiarsquos Immunization Technique DVD Best Practices with Infants Children and Adults
Page 52 IPI Advisor Manual| February 2017
IPI Advisor Resource List Chapter 5
CDC ldquoPink Bookrdquo wwwcdcgovvaccinespubspinkbookindexhtml
CDC Advisory Committee on Immunization Practices (ACIP) wwwcdcgovvaccinesacip
CDC Vaccines and Immunizations wwwcdcgovvaccines
VAERS reporting httpvaershhsgovindex
Storage and Handling Got Your Shots Providers Guide ndash Managing Vaccine wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml
MnVFC Guide to Temperature Monitoring Devices wwwhealthstatemnusvfc
MDH Clinicianrsquos Vaccine Mishap Checklist wwwhealthstatemnusdivsidepcimmunizeipivaxchklstpdf
MDH Vaccine Storage Guide wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml
CDC Vaccine Storage and Handling Toolkit wwwcdcgovvaccinesrecsstoragetoolkit
You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Vaccine manufacturer phone numbers wwwcdcgovvaccinespubspinkbookdownloadsappendicesFcontact-info-manufactpdf
IAC Checklist for Safe Vaccine Handling and Storage wwwimmunizeorgcatgdp3035pdf
IAC Donrsquot Be Guilty of These Errors in Vaccine Storage and Handling wwwimmunizeorgcatgdp3036pdf
Additional Resources Print materials from MDH ndash order forms wwwhealthstatemnusdivsidepcimmunizeordermathtml
Vaccine Education Center ndash Childrenrsquos Hospital of Philadelphia wwwchopeduservicevaccine-education-centerhomehtml
California Department of Public Health ndash Interactive training on vaccine administration and storage and handling handout on transporting vaccine and how to package wwwezizorg
IPI Advisor Manual | February 2017 Page 53
IPI Advisor Resource List Chapter 5
CDC vaccine price list wwwcdcgovvaccinesprogramsvfcawardeesvaccine-managementprice-listindexhtml
Vaccine Information Statements (VIS) wwwcdcgovvaccineshcpvisindexhtml
CEU Opportunities CDC Immunization Education and Training wwwcdcgovvaccinesedindexhtml
Immunization You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Page 54 IPI Advisor Manual| February 2017
- Introduction
-
- Welcome to the Immunization Practice Improvement (IPI) Program
- Contact Information
-
- Chapter 1
- Requirements to Participate in the MnVFC Program
- Vaccines for Children Program
- Chapter 2
- Reimbursement for MnVFC Visits
- Types of Visits
- Your MnVFC Clinical CoordinatorPlanner
- New IPI Advisor Training Requirements
- Your Role as an IPI Advisor
- Reasons MDH Would Do All or Part of a Visit
- Chapter 3
- Future follow-up
- Conducting the Visit
- Preparing for the Visit
- Information for the Visit
- Site Visit Checklist
- Scheduling the Visit
- Chapter 4
- After the Site Visit
- MnVFC Provider Follow-up Plan
- MnVFC Site Visit Storage and Handling Per Unit Answer Sheet
- Section 6 Inventory
- Section 5 Storage amp Handling Site-Wide
- Section 4 Storage amp Handling Per Unit
- Section 3 Documentation
- Section 2 Eligibility
- Section 1 Provider Details
- The Site Visit Reviewer Legend
- MnVFC Site Visit Questionnaire
- Required Paperwork for Site Visits
- Chapter 5
-
The IPI Program Chapter 1
bull Uninsured bull Enrolled in a Minnesota Health Care Program Medical Assistance (MA) or MinnesotaCare bull American Indian or Alaskan Native or bull Underinsured children that are seen at a local health department Federally Qualified Health Center (FQHC) or Rural Health Center (RHC) Indian Health Services (IHS) and tribal health clinics
The majority of pediatric and family practice clinics are enrolled in MnVFC so children can stay with their health care home and still receive low-cost immunizations
When Congress enacted the VFC program they wanted to ensure that bull Sites manage their VFC vaccine appropriately so that there is little to no wastage of this valuable asset bull All eligible children receive the vaccine bull Immunization coverage rates increase by removing barriers to vaccination especially among high-risk children and by reducing disparities in access to health care
bull Vaccine is not used for the purpose of gaining profit for the provider or site
To assure these goals are achieved all states are required to conduct site visits for each enrolled site at least every other year As an IPI advisor you will be conducting the required MnVFC site visits in your county
Minnesota receives approximately $48 million of federally funded vaccine through the MnVFC program each year It is extremely important that these vaccines are managed properly and given only to the individuals that are eligible to receive them
Requirements to Participate in the MnVFC Program Initially providers must go through an enrollment process with MDH to receive vaccine from the MnVFC program This requires filling out the enrollment paperwork meeting the requirements in the appropriate MnVFC Policies and Procedures Manual and having an enrollment site visit by MDH staff
Following enrollment all sites receive their first MnVFC site visit within one year (preferably in 3-6 months) and then a MnVFC site visit at least every other year If you know of a provider who is not enrolled in the program a new clinic opens or if a site opens a satellite site in your county have them call the MnVFC program at 651-201-5522 to begin the enrollment process
Sites must meet many requirements to receive vaccine from the MnVFC program These requirements are identified in the MnVFC Policies and Procedures Manual There are two versions of the manual one for sites that keep separate stocks of public and private vaccine and another for sites that use the replacement method of vaccine management A copy of the appropriate manual is mailed to each site every fall The immunization manager vaccine coordinator and their back-ups must complete the annual online training based on the method of vaccine management their site uses All of the materials can be found on the MnVFC website (wwwhealthstatemnusvfc) Sites must complete the appropriate reports agreements and online training each year in order to continue to receive vaccine from the MnVFC program
Page 6 IPI Advisor Manual| February 2017
Chapter 2 IPI Advisors Your Role as an IPI Advisor As part of an MDH grant agreement with community health boards MDH contracts with local public health agencies to conduct MnVFC site visits in their county
As an IPI advisor you will be responsible for bull Attending the annual training provided by MDH bull Reviewing your county site visit lists and providing any known updates to your MnVFC clinical coordinatorplanner
bull Conducting site visits completing and submitting paper work within 10 days of the visit bull Following up with sites for unmet requirements identified at MnVFC site visits bull Notifying MDH when new sites open that will be storing and administering immunizations (in order to recruit new providers)
bull Keeping up-to-date with new recommendations and requirements for immunizations as well as the MnVFC program Read and be familiar with MnVFC and IPI web pages Sign up to receive email alerts for these resources by clicking on the red envelope at the top of these pages MnVFC Announcements (wwwhealthstatemnusdivsidepcimmunizemnvfcbfaxhtml) Got Your Shots News newsletter (wwwhealthstatemnusdivsidepcnewslettersgysindex html) Immunization Practices Improvement Program (wwwhealthstatemnusdivsidepc immunizeipiindexhtml)
Be designated as the IPI contact in Workspace (httpsoephealthstatemnusworkspace) for your organization Contact your organizationrsquos Workspace administrator to assign you this role
Annual training
Every spring MDH provides training for IPI advisors This training may be in-person or by webinar All IPI advisors are required to attend training each year to review site visit paperwork hear updates on the MnVFC program and ask questions about the process
Clinic lists
Early in the year MDH will send you a clinic list Your list will include all sites in your county that are enrolled in the MnVFC program The priority column indicates whether the IPI advisor MDH staff or the field epidemiologist should complete the visit Those sites not due for a visit that year will have the next year listed Every active MnVFC site is required to receive a site visit at least every other year You can do visits every year if you would like but this is not required Please review the list and notify your MnVFC clinical coordinatorplanner about any changes
IPI Advisor Manual | February 2017 Page 7
IPI Advisors Chapter 2
Included with the list is a one-page information sheet for each site This contains the sitersquos demographic information vaccine coordinator and immunization manager listed in our records whether they are a separate stock or replacement site and the doses and cost of vaccine they received last year Confirm this information with the site and discuss their vaccine quantity and value as part of the questionnaire during your visit
All site visits must be completed by Sept 30 2017 If you think you will be unable to complete all your visits by then you will need to contact your MnVFC clinical coordinatorplanner to determine how the visit will be completed
New IPI Advisor Training Requirements New IPI advisors need to contact MDH before performing any MnVFC site visits on their own A MnVFC clinical coordinatorplanner will help you prepare to perform site visits They will
bull Guide your training See the Training Checklist for IPI Advisors on the IPI Program Resources (wwwhealthstate mnusdivsidepcimmunizeipiresourceshtml) page
bull Have you shadow them or another experienced IPI advisor on one or two site visits bull Shadow you on a visit or two bull Complete the training document
Your MnVFC Clinical CoordinatorPlanner Your MnVFC clinical coordinatorplanner is a MDH staff member that will help support you See who your clinical coordinatorplanner is on IPI Contact Information (wwwhealthstatemnusdivsidepc immunizeipicontacthtml)
The role of the MnVFC clinical coordinatorplanner bull Provide assistance to IPI advisors bull Perform enrollment visits for new sites that will be administering MnVFC vaccine bull Review MnVFC site visit paperwork for accuracy bull Conduct MnVFC site visits where necessary bull Provide additional education or follow-up with sites bull Provide assistance and guidance regarding MnVFC requirements and recommendations to sites bull Provide training to IPI advisors and staff at MnVFC-enrolled sites bull Field storage and handling incident calls
Types of Visits MnVFC Site Visit ndash also known as the Compliance Visit
CDC requires all state immunization programs to conduct site visits to all VFC providers MnVFC site visits are required every other year but sites can be visited on a yearly basis if needed The site visit objectives are to
Page 8 IPI Advisor Manual | February 2017
IPI Advisors Chapter 2
bull Complete the MnVFC site visit paperwork found on IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml)
bull Provide education about MnVFC program requirements and recommendations to site staff bull Ensure MnVFC program requirements are properly implemented and are being met bull Provide feedback and as necessary execute corrective action bull Follow-up on identified issues bull Notify your MnVFC clinical coordinatorplanner of issues that are not resolved by the due date
Follow-Up Visit
In-person follow-up visits will not be necessary for most MnVFC site visitsmdashonly those where significant issues are identified in the original visit If you are not able to complete part of the initial site visit because you found a storage and handling incident or you found multiple issues that need to be addressed a follow-up visit may be necessary Please contact the MnVFC clinical coordinatorplanner for approval and guidance for conducting a follow-up site visit
Educational Visit
Some sites may need more information and education than you can provide during a normal site visit This may be on topics related to immunizations immunization practices or administration or storage and handling issues These visits go beyond the sharing of pamphlets resources or information that is presented at a site visit Education visits should be conducted with a group and should focus on a topic that is identified during a site visit or requested by site staff Regularly scheduled meetings are not considered educational visits Educational visits need to be approved prior to the visit by the MnVFC clinical coordinatorplanner in order for you to receive reimbursement from the MnVFC program
Unscheduled (Unannounced) Storage amp Handling Visit
Unscheduled (unannounced) visits are not pre-scheduled with the site These visits require different paperwork and focus primarily on the storage and handling portion of a MnVFC site visit The MnVFC program is required to visit 5 percent to 10 percent of enrolled sites as unannounced visits each year Please discuss any unscheduled visits you would like to do with the MnVFC clinical coordinatorplanner You should plan to complete all of your regularly scheduled visits before doing any unscheduled visits
Enrollment Visit
All sites (including satellite clinics) that receive stock or supply MnVFC vaccine must have an enrollment visit that is conducted by MDH staff As an IPI advisor you may be asked to attend the enrollment visit This is an opportunity for you to start your relationship with the site and help with follow-up that may be necessary for the site to receive MnVFC vaccine Newly enrolled sites are scheduled for their first regular site visit within the first year (preferably within 3 to 6 months) and then every other year
IPI Advisor Manual | February 2017 Page 9
IPI Advisors Chapter 2
Reimbursement for MnVFC Visits Local public health agencies are paid for the site visits they conduct MDH will reimburse participating agencies only after we receive all of the required paperwork Paperwork submitted with incorrect or missing information may delay the reimbursement
IPI program reimbursement is processed on a quarterly basis and is processed in the month following each quarter through an electronic transfer of money Your agencycounty IPI advisor contact will receive an email notification of the reimbursement
Reimbursement rates are updated annually and available on the Contracts and Reimbursements (www healthstatemnusdivsidepcimmunizeipicontreimhtml) page
2017 MnVFC Site Visit Reimbursement Rates MnVFC Site Visit $400 Follow-up Visit$150 Education Visit$100 Unscheduled Visit$300
Reasons MDH Would Do All or Part of a Visit MDH may complete site visits or accompany you on a site visit if
bull The site is new to the MnVFC program (enrollment visit) bull The site has known issues or concerns regarding the MnVFC program especially if you are having difficulty resolving these issues
bull The site is refusing a site visit from local public health or yoursquore having a difficult time scheduling a visit
bull The site is part of tribal health or Indian Health Services bull MDH district epidemiologists will perform site visits at local health departments bull A new IPI advisor needs training from MDH staff bull Note MDH district epidemiologists will perform site visits at local health departments
Page 10 IPI Advisor Manual | February 2017
Chapter 3 Site Visits Scheduling the Visit
bull Check the information sheet or contact the site to confirm who the contact person is in charge of the MnVFC program In general this is the immunization manager or vaccine coordinator If the contact is no longer there ask for the person in charge of the sitersquos vaccines or the clinic manager They can usually direct you to the appropriate person You may want to follow a suggested phone script when contacting the site
Sample Phone Script for Scheduling a Visit
ldquoHello My name is _______ I am calling from ________ Health Department May I speak to (contact name) [If not available determine appropriate person to talk to or a better time to call back] I am calling to schedule a MnVFC site visit This visit will involve a review of immunization practices at your site We will look at vaccine administration storage and handling screening for eligibility and documentation of vaccinations It usually takes about two hours for a visit depending on the number of vaccine storage units you have Is there a day or time of day that works best for you
I have a pre-visit worksheet to send to you to help you prepare for the visit It contains information about what I will need at the visit such as temperature logs and immunization documentation information Completing this worksheet prior to me arriving will help the visit be more efficient Is there any other information that I can send to help you prepare for the visit
If you have any questions call me at ________ Thank you for your time and assistance I look forward to working with yourdquo
bull Arrange a date and time for the visit bull Let them know an approximate visit length Visits are usually around two hours long depending on the size of the site the number of vaccine storage units they have or if they have new staff
bull Request that key staff be present at the visit This could include the immunization manager vaccine coordinator immunization staff clinic manager nurse manager billing staff andor medical director
bull Inform your site contact that you will be sending them an email confirmation along with the MnVFC
Pre-Visit Worksheet
Site Visit Checklist Use the Site Visit Checklist on IPI Advisor Site Visit Materials (wwwhealthstatemnusdivs idepcimmunizeipisvmaterialshtml) to make sure all necessary steps are covered
MINNESOTA VA C CI N ES FO R CHI LD REN PROGRAM
Site Visit Checklist Date of visit Time
Site Name PIN
Address
Contact Phone
Complete Before the visit Comments
Review the clinic list Identify and prioritize which sites you will visit
Email or call to schedule a date and time for the visit Ask for the immunization manager or vaccine coordinator
Email appointment confirmation attach Pre-visit Worksheet and provide instructions for returning it prior to the visit (sample email on website) Include length of the visit and which staff should be present
Add site visit to Outlook calendar and reserve a car (if needed)
Review temp logs and Pre-visit Worksheet
Send a reminder email 2-3 days ahead of the visit
IPI Advisor Manual | February 2017 Page 11
i i li
Site Visits Chapter 3
Information for the Visit2017 MnVFC Pre-Visit Worksheet Site name MnVFC PIN
Address
Medical director Email
Immunization manager Phone
Vaccine coordinator Phone
Vaccine coordinator back-up Email
IPI Site Vis t Preparat on Check st
The staff listed have completed the MnVFC online training and printed a certification of completion Immunization Manager Vaccine coordinator Vaccine coordinator back-up
Have a copy of the most recent provider agreement
Check if the above listed staff have changed since the provider agreement was completed
Check all of the vaccines administered at your site and list the corresponding publication date for each VIS you give to patients
DTaP _____________ Hepatitis A _____________ Hepatitis B _____________ Hib _____________ HPV _____________
Influenza _____________ MCV4 _____________ MMR _____________ MMR-V _____________ PCV13 _____________
Polio _____________ Rotavirus _____________ Tdap _____________ Varicella _____________
Non-Routine Vaccines Men B__________ PPSV23 _____________ Td _____________
Vaccine administration fee charged for MnVFC eligible children is $
Have a Vaccine Management and Emergency Plan that has been reviewed and dated within the last year
Have the borrowing reports if applicable for the last 12 months available at the visit
Have an anaphylaxis protocol that is clearly posted and reviewed annually
Send an appointment reminder email and the MnVFC Pre-Visit Worksheet to the MnVFC contact A sample letter and the MnVFC Pre-Visit Worksheet can be found on the IPI Advisor Site Visit Materials (wwwhealthstate mnusdivsidepcimmunizeipisvmaterialshtml) page You can request that the MnVFC Pre-Visit Worksheet and temperature logs be sent to you prior to the visit for your review
Contact the site by phone or email one or two working days before the scheduled visit to confirm your appointment This is also a good time to ask for directions and parking information if you are not familiar with the site
Preparing for the Visit Review the site visit paperwork to familiarize yourself with the questions For most of the questions there is a ldquoNote to the reviewerrdquo These notes give helpful tips about the information you are looking for when asking this question It contains the rationale for the question and which resources to provide to the site to support the rationale Some sections also require immediate on-site actionsmdashthings you must do while you are at the site and some require future follow up
bull Print copies the of site visit paperwork bull Site visit forms are available on the IPI Advisor Site Visit Materials (wwwhealthstatemnusdivs idepcimmunizeipisvmaterialshtml) page 2017 MnVFC Site Visit Questionnaire 2017 MnVFC Site Visit Storage amp Handling per Unit Answer Sheet (print one for each stand-alone andor combination storage unit at the site) 2017 MnVFC Provider Follow-up Plan (print two copies)
bull Review any previous site visit paperwork that is available You should check in with MDH staff after your visits if the site continues to have the same issues as past visits
bull Also be sure to bring Your thermometers If the sitersquos certificate of calibration is expired or the probe is not properly placed place your thermometer in the storage unit when you arrive and read the temperature just prior to reviewing the site visit findings
The MnVFC folder with additional immunization resources you wish to add (see chapter 5) and the Vaccine Storage amp Handling magnet (to order email healthIPIinquiriesstatemnus) A copy of the appropriate MnVFC Policies and Procedures Manual found on the MnVFC website (wwwhealthstatemnusvfc) Appropriate temperature logs (Celsius or Fahrenheit) Site information sheet that contains the quantity and value of the vaccine distributed to the sitesystem
Page 12 IPI Advisor Manual | February 2017
Site Visits Chapter 3
Conducting the Visit Education is a large part of the MnVFC site visit Often approaching this visit as an exchange of information with the site is more successful than a ldquoregulatoryrdquo visit Putting the staff at ease answering their questions and making a plan to address issues that arise during the visit is more helpful than a ldquopassfailrdquo attitude Education will usually consist of providing the rationale for the requirement referring to the requirement in the MnVFC Policies and Procedures Manual and providing resources to help address the situation Some questions will require additional follow-up to assure the site has corrected the issue(s) and is meeting the MnVFC requirement(s) This will be addressed further in the follow-up section
Completing the Paperwork
There are three documents that you must complete for the MnVFC site visit bull 2017 MnVFC Site Visit Questionnaire bull 2017 MnVFC Site Visit Storage amp Handling per Unit Answer Sheet (one for each storage unit) bull 2017 MnVFC Provider Follow-up Plan (two copies or you may ask them to make you a copy of the completed form for their records)
Answer the questions on the MnVFC Site Visit Questionnaire based on how things are when you arrive at the site If they correct the issue during the visit you will still mark it as an unmet requirement and document how it was addressed during the visit
The ldquoAnswerrdquo field will contain all the possible answer choices for this question For most questions answer choices will be followed by the markings below
bull Answer choices with no marking mean the site meets the CDC requirement bull Answer choices marked with an [X] indicate that this specific answer choice is non-compliant with a CDC requirement
bull Answer choices marked with an [O] indicate that this specific answer choice is not aligned with a CDC recommendation
If you marked the box with the [X] which is non-compliant with the CDC requirement conduct a root cause analysis to determine the reason for non-compliance Root cause analysis is an important component to a successful site visit It is used to identify the cause of the problem and help to resolve the issue There are several possible root causes that can be identified Choose only one root cause
bull Human cause Personal beliefsopinions Does not understand rationale of requirement Lack of concern for compliance
bull Organizational cause Competing job assignmentsworkload Lack of (insufficient) staff to perform required duties Budget limitations (for required equipment) Lack of (insufficient) training of staff Lack of (insufficient) processesprotocols
IPI Advisor Manual | February 2017 Page 13
Site Visits Chapter 3
Once identified the root cause should be documented in the questionnaire including a brief explanation of why you chose that cause This allows for follow-up with the site and a way to help find improvements to meet the unmet requirement Complete any immediate on-site action These often require providing education and resources for the site Mark the box for each action taken If you provide additional resources or information you can use the notes section to indicate the additional items
ldquoFuture follow-uprdquo are actions the site needs to take to meet the requirements of the program Wersquoll go over more specific information about the site visit questionnaire in Chapter 4
Performing the Site Visit
As you become familiar with the MnVFC program and develop a relationship with your sites you will develop a visit pattern that works for you Here is one possible sequence for conducting MnVFC site visits
bull When you arrive at the site if you have a business card it is helpful to provide it to the front desk staff person
bull When you meet with the immunization manager andor vaccine coordinator introduce yourself and explain the expectations for the visit
bull Ask to see the temperature monitoring device(s) It must have a current certificate of calibration and the probe must be properly placed in the unit If it does not meet the requirements place your thermometer in the unit at the beginning of the visit so that it has sufficient time to reach an accurate temperature by the time you complete your assessment of the storage units
bull 2017 MnVFC Site Visit Questionnaire Ask all of the questions You may have to modify the order of the questions based on what is best for the site When you get to the storage and handling section (section 4) use the answer sheet(s) to document the answers to the questions for each storage unit that stores vaccine (MnVFC or private) Do not write answers in the questionnaire unless there is an unmet requirement Be sure to ask if there is vaccine stored anywhere else at any time at this location This includes a co-located pharmacy If so these additional units will need to be assessed as well If the site has a combination refrigeratorfreezer household unit and is using both sections discuss with them the recommendation (and probable future requirement) to have a separate freezer Refer to MDH if they have further questions or need more information Be prepared to address any storage and handling mishaps that you may find A copy of the
Clinicianrsquos Vaccine Mishap Checklist is with your visit materials and the Emergency Response Worksheet is in the MnVFC Policy and Procedure Manual If you are unsure how to handle the problem call the MnVFC program at 651-201-5522 during or after the visit
Page 14 IPI Advisor Manual | February 2017
Site Visits Chapter 3
Ending the Visit bull Fill out the two copies of the 2017 MnVFC Provider Follow-up Plan (or ask them to make a copy once it is completed for their records) Indicate if they have not met the requirement by checking the box in the ldquoUnmetrdquo column If they are not meeting requirements check the required actions Review the plan with them reinforcing the positive things they are doing as well as reviewing the required follow-up action(s) Give the site a copy of the Provider Follow-up Plan Keep the signed copy of the Provider Follow-up Plan to submit with your paperwork Do not leave a copy of the Site Visit Questionnaire at the site
bull Let them know you will be sending a thank you email that will summarize the site visit Included in the email will be a survey link you would appreciate them completing regarding the visit
After the Visit bull Send the site a thank you email There is a template thank you letter on the IPI Advisor Site Visit Materials (wwwhealthstate mnusdivsidepcimmunizeipisvmaterialshtml) page Be sure you include the issues that you identified and the timeline for their completion as well as the good things you found at the visit In the template letter be sure to include the survey link The survey is very brief ndash a few questions and space to write comments
bull Either transfer your MnVFC Site Visit Questionnaire and MnVFC Site Visit Storage amp Handling per Unit Answer Sheet information to the fillable version or submit the handwritten form to MDH
Documentation of the Visit
Paperwork must be submitted to MDH within 10 days of the visit in order to meet the federal VFC programrsquos reporting requirements Do not wait to complete your follow-up before submitting the site visit paperwork
Send the following documents to MDH bull 2017 MnVFC Site Visit Questionnaire (includes the cover sheet) bull 2017 MnVFC Site Visit Storage amp Handling per Unit Answer Sheet (one for each unit) bull 2017 MnVFC Provider Follow-up Plan (original signed plan)
Submit site visit materials to bull Email healthIPIinquiriesstatemnus (preferred) bull Mail IPI Program Specialist
Immunization Practices Improvement Program Minnesota Department of HealthPO Box 64975St Paul MN 55164-0975
IPI Advisor Manual | February 2017 Page 15
Site Visits Chapter 3
Future follow-up Follow-up is an important component of the site visit It helps us ensure that the unmet requirements have been corrected The questionnaire has different time periods for follow-up depending on the question Do not wait to complete your follow-up before submitting the site visit paperwork
When you complete the Follow-Up Form make sure to keep a copy for yourself MDH also keeps track of follow-up required and will remind you if follow-up has not been completed by the deadline Most follow-up can be done with a phone call or email In-person follow-up is rarely required and should be discussed with MDH before scheduling a follow-up visit
All requirements that need follow-up are identified with a [X] on the site visit paperwork and are listed on the MnVFC Provider Follow-up Plan
bull Follow-up with the site to see how they have resolved the unmet requirements bull Document your follow-up on the Follow-Up Form available on the IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml) page If follow-up was done via letter or email a copy can be attached to the Follow-Up Form
bull Send your Follow-Up Form to MDH (healthIPIinquiriesstatemnus) with supporting documents and emails
bull If a site is not responding to your requests regarding follow-up contact your MnVFC clinical coordinatorplanner They can help with additional follow-up as needed
Page 16 IPI Advisor Manual | February 2017
Chapter 4 The 2017 MnVFC Site Visit Paperwork This chapter will go through the required MnVFC site visit paperwork with notes about information or resources to help the site address questions or issues that may arise during the visit
The MnVFC site visit paperwork is available on the IPI Advisor Site Visit Materials (wwwhealthstate mnusdivsidepcimmunizeipisvmaterialshtml) page
Please download the paperwork shortly before your visit as there may be updates and changes and this will be the most up-to-date version of the questionnaire We will send out a Workspace message with major changes
Required Paperwork for Site Visits bull 2017 MnVFC Site Visit Questionnaire bull 2017 MnVFC Storage amp Handling Per Unit Answer Sheet ndash one for each unit assessed during site
visit bull 2017 MnVFC Provider Follow-up Plan ndash with provider signature
Make sure to include the sitersquos PIN on all your paperwork Please complete and submit your site visit paperwork as soon as possible after your visit It may be helpful to schedule some time into your calendar to complete your paperwork in the days following your visit Once you have completed the post-visit follow-up send in the Follow-Up Form with documentation of the follow-up actions Please do not wait until you have completed your follow-up before sending in your initial paperwork
MnVFC Site Visit Questionnaire The questionnaire includes these six sections 1 Provider details 2 Eligibility 3 Documentation 4 Storage amp handling per unit 5 Storage amp handling site-wide 6 Inventory
IPI Advisor Manual | February 2017 Page 17
Page 18 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
The Site Visit Reviewer Legend The legend explains the formatting of the 2017 questionnaire This includes information that will be helpful in completing the site visit
Site Visit Reviewer Guide Legend
Section Number Content Area
Question number This area will always contain the text of the question
Note to reviewer The note to reviewer contains information that is necessary for properly asking and assessing responses tothe question above This may include definitions of terms requirement details and other helpful tips
Answers This field will contain all the possible answer choices for this question For most questions answer choiceswill be followed by the markings below
Answer choices marked with an [X] indicate that this specific answer choice is non-compliant with a CDC requirement Answer choices marked with an [O] indicate that this specific answer choice is not aligned with a CDC
recommendation
Review CDC RequirementRecommendation
This field will be populated with the CDC requirementrecommendation associated with the given question
Actions if Non-Compliant
Root Cause Analysis As part of the site visit reviewers are required to assess and understand the reasons why a provider office isnon-compliant with VFC program requirements ndash this is a root cause analysis Reviewers must choose theone root cause that they believe most contributes to the non-compliance Upon establishing the root causethe reviewer must provide a clear explanation of hisher findings
Immediate Action These are actions that CDC requires reviewers to take on site during the visit
Future Follow-up These are future follow-up actions (with designated due dates) that are required of the reviewer andorprovider to remedy non-compliance Reviewers must complete all follow-up in accordance with CDCestablished deadlines
Notes Information you want the VFC program to be aware of or that explains your answer in detail
bull Note to reviewer These are notes to help you understand what the question is asking for and to clarify things you might want to know when asking or rephrasing the question
bull Answers This section helps you to know when the answer does not meet the CDC requirement [X] or recommendation [O] Whenever an answer with a [X] is checked the ldquoActions if Non-compliant section must be completed The recommendations are usually good teaching points about best practices andor future requirements of the VFC program
bull Review the CDC RequirementRecommendation This section provides a specific outline of the requirement or recommendation to give you information to use in talking with the site staff
bull Actions if Non-Compliant This section describes what to do if the site is not meeting a requirement Root cause analysis This section asks you to probe beyond the surface to find what is driving the non-compliance It is intended to help uncover reasons for recurring non-compliance issues identify additional training needs and inform reviewer follow-up actions Select only one root cause and explain the particular circumstances in the space ldquoExplanation of root causerdquo line provided If there appear to be multiple issues choose the one that most contributes to the non-compliance and describe all factors in the explanation Immediate actions A list of actions to take during the site visit to address the issue Future follow-up A list of actions to take after the site visit by the set deadline
bull Notes This section can be used for notes to yourself or to MDH
IPI Advisor Manual | February 2017 Page 19
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 1 Provider Details Questionnaire Coversheet
The first page of the questionnaire collects the demographic information for the site You can use this page to help prepare for the visit Most of the demographic information about the site should be on the site-specific document you received with your clinic list You will validate that this information is current at the time of the site visit It also helps to know if this is a separate stock site or a replacement site before the visit so you can bring a copy of the appropriate MnVFC Policies and Procedure Manual
2017 MnVFC Site Visit Questionnaire Date of visit _____________ Date forms sent to MDH ______________
Site Information
Site name MnVFC PIN
Address Separate Stock Replacement
City ZIP County
Medical Director Email
Immunization Manager Phone
Vaccine Coordinator Phone
Vaccine Coordinator back-up Email
Point of contact Phone
Personnel at site visit
On this page bull The date of the visit and the date when you send these forms to MDH This information helps us track the timeliness of our review and data entry process
bull The vaccine management method used by the site (replacement or separate stock) bull The name and email of the medical director (ideally this is the person who signed the MnVFC
Program Provider Agreement)bull Contact information for the immunization manager vaccine coordinator vaccine coordinator back-up and point-of-contact for this visit The immunization manager vaccine coordinator vaccine coordinator back-up roles are
described in the MnVFC Policies and Procedure Manual The vaccine coordinator back-up may be the immunization manager or another staff person depending on the size of the site and available personnel The Point of Contact is the person you set up the appointment with signs the Provider Follow-
up Plan and receives the follow-up email This may be one of the people listed above
The Post Visit Steps section is a reminder to you about what needs to done after the visit The Education on Immunization Best Practices for Sites section reminds you to provide the resource folder to the site
Page 20 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 12
1 Provider Details Changes to Key Staff
Question 12 Ask the provider about changes to key staff to answer the questions below
A (Choose all that
apply)
At the time of the visit is the Medical Director the same individual that signed the ProviderAgreement and are the Immunization Manager and Vaccine Coordinator the same asthose last reported to the program
Yes No the Medical Director has changed No the Immunization Manager has changed No the Vaccine Coordinator has changed
B (Choose one)
Were all changes communicated to theImmunization Program according to yourprogramrsquos policy
Yes or no staff changes No [X]
C (Choose one)
Based on review of the trainingdocumentation have the current Immunization Manager Vaccine Coordinator and back-up completed all required training
Yes No [X]
Review CDC Requirement
All changes in key staff must be communicated to the Immunization Program in the manner and timeframe defined by theImmunization Program Key staff include the Medical Director or equivalent who signed the Provider Agreement the Immunization Manager Vaccine Coordinator and the back-up VFC providers are required to ensure that all key staff are fully trained on VFC program requirements at all times All training must be documented
Goal of this question Determine if there are new staff in key positions at the site and to make sure staff are properly educated about the MnVFC program A This information can help you determine the level of knowledge and experience the staff have with the MnVFC program Follow-up throughout the visit can be tailored for various levels of staff experience Likewise you may identify additional training needs for new staff
B When sites notify us of changes in key personnel we update their information in MIIC and on the clinic lists We also send the new staff information for completing the online training and direct them to read the appropriate MnVFC Policies and Procedures Manual If the answer to this part is no update the demographic area of the questionnaire and inform the staff that in the future they must notify the MnVFC program (via email or phone) if the immunization manager or vaccine coordinator changes Resource Section 12 of the MnVFC Policies and Procedures Manual
C Annual training must be verified by looking at the certificates for the online training If the answer to this part is no refer the staff to complete the appropriate MnVFC online training found on the MnVFC website (wwwhealthstatemnusvfc) for their program (separate stockreplacement) for the current year and send you a copy of the certificate within 30 days
Resource bull Sections 12 and 14 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 21
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 2 Eligibility Question 21
Goal of this Question Assess whether staff correctly understand which patients are eligible for the MnVFC program Screening ensures that eligible children receive the vaccines that they are entitled to receive under the MnVFC program and helps to prevent fraud or abuse of the program
Children 18 years and younger in these
categories can receive MnVFC vaccine at any enrolled site bull Uninsured bull Enrolled in a Minnesota Health Care Program (MHCP) Medical Assistance (MA) or MinnesotaCare bull American Indian or Alaskan Native
The following categories are considered underinsured and are only MnVFC-eligible at local public health (LPH) Federally Qualified Health Centers (FQHC) Rural Health Centers (RHC) Indian Health Services (IHS) and tribal health clinics
bull Has health insurance that does not cover one or more vaccines as can be the case with newly licensed vaccines that arenrsquot yet covered (MnVFC-eligible for non-covered vaccines only)
bull Has health insurance that caps vaccine coverage at a certain amount Once that amount is reached the child is MnVFC-eligible
Children with insurance that does not cover vaccines until a deductible has been met are considered to be fully insured and are not MnVFC-eligible
Helpful information bull Sites are not required to verify the patientrsquos response to the screening questions For example if a patient states they lost their insurance the site does not need to call the patientrsquos insurance company to confirm
If the site cannot correctly describe the eligibility categories provide educational materialsresources on MnVFC eligibility requirements
Resources bull Patient Eligibility Screening Record on MnVFC Forms (wwwhealthstatemnusdivsidepc immunizemnvfcformshtml)
bull Section 1 of the MnVFC Policies and Procedures Manual
2 Eligibility VFC Eligibility Categories
Question 21 Was the individual responsible for determining patient VFC eligibility able to explain all the factors(including age) that make a child eligible to receive VFC vaccines
A Patient is less than 19 years of age Yes No [X]
B Patient is Medicaid-eligible Yes No [X]
C Patient is uninsured Yes No [X]
D Patient is underinsured Yes No [X]
E Patient is American Indian Yes No [X]
F Patient is Alaska Native Yes No [X]
Review CDC Requirement
VFC providers must possess a working knowledge of all VFC eligibility criteria and use those criteria to screen children prior toadministering VFC vaccines In order to receive VFC vaccine a patient must be under the age of 19 and must be at least one of the following (1) Medicaid-eligible (2) Uninsured (ie child has no health insurance) (3) Underinsured (ie child has health insurancebut coverage does not cover any or certain vaccines ndash underinsured children may only receive VFC vaccines in FQHCRHC ordeputized VFC provider offices and only for vaccines not covered by insurance) and (4) American Indian or Alaska Native (AIAN)
Page 22 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 22
2 Eligibility Billing Practices
Question 22 Is the individualdepartment responsible for billing able to clearly explain how they bill for both the costof vaccine and the vaccine administration fee for each of the eligibility categories below
A Medicaid-eligible Cost of Vaccine Do not bill ndash provided by VFC Admin Fee Bill Medicaid
Yes No [X]
B Uninsured Cost of Vaccine Do not bill ndash provided by VFC Admin Fee If billing can bill patient
Yes No [X]
C Underinsured Cost of Vaccine Do not bill ndash provided by VFC through FQHCsRHCs or deputized providers only all other providers cannotprovide VFC vaccine to underinsured patients Admin Fee If billing can bill patient
Yes No [X]
D American IndianAlaska Native(AIAN)
Cost of Vaccine Do not bill - provided by VFC unless patient is fully insured and parent chooses to use insurance Admin Fee If patient is Medicaid-eligible bill Medicaid if billingand patient is uninsuredunderinsured can bill patient if parentchooses to use private insurance for cost of vaccine billpatientinsurance
Yes No [X]
E Do individuals responsible for billing have access to the results of eligibility screening toensure proper billing
Yes No [X]
Review CDC Requirement
VFC providers must adhere to proper billing practices for vaccine administration fees and clearly understand that VFC vaccine isprovided at no cost to both the VFC provider and eligible children At no time should billing occur for the cost of VFC vaccine Whenadministering VFC vaccine providers should never bill two different ldquopayersrdquo (ie patient Medicaid insurance) for the samevaccine administration fee amount For Medicaid-eligible children Medicaid should be billed for the vaccine administration fee Forall other VFC-eligible populations the patient may be billed within the stateterritory cap established by the Centers for Medicareand Medicaid (CMS) However patients cannot be turned away or reported to collections for inability to pay the administration fee
Goal of this question Determine if the staff correctly understand how to bill patients that are eligible for the MnVFC program Billing appropriately ensures that children can receive low cost immunizations and the site is in compliance with the VFC program
bull If there is any indication that sites could be billing insurance companies or parents for VFC vaccines this should be investigated further
bull Most sites in Minnesota will bill Medicaid with the SL modifier ndash which indicates this is a Medicaid claim
bull The main point is to ensure the site is not billing uninsured children for VFC vaccine and are not charging them more than $2122 per vaccine for the administration fee
bull Non-compliance is usually unintentional and may be resolved with some training In rare cases it could be a glimpse into a larger problem where a site is intentionally billing for financial gain
bull If you think the site is billing inappropriately it is the responsibility of the IPI advisor to report concerns to MDH staff for further assistance
Resources bull Immunization Billing Guidance for MnVFC (wwwhealthstatemnusdivsidepcimmunizemnvfc billingtipshtml) or Immunization Billing Guidance for MnVFC Replacement Method Sites (www healthstatemnusdivsidepcimmunizemnvfcreplacementbillingtipsrephtml)
bull Section 2 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 23
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 232 Eligibility Vaccine Administration Fee
Question 23 Document the actual vaccine administration fee charged to non-Medicaid VFC-eligible patients (confirmwith billing department)
Answers Fee $ [X] Follow-up is required if the provider charges more than the fee cap establishedby the Centers for Medicare and Medicaid (CMS) for your stateterritory ($2122)
Review CDC Requirement
The VFC providerrsquos vaccine administration fee for non-Medicaid VFC-eligible children must not exceed the stateterritory vaccineadministration fee cap established by the Centers for Medicare and Medicaid (CMS) For current fee caps refer to Medicaid Program Payments for Services Furnished by Certain Primary Care Physicians and Charges for Vaccine Administration Under theVaccines for Children Program Final Rule (httpwwwgpogovfdsyspkgFR-2012-11-06pdf2012-26507pdf)
Goal of this question Ensure that sites are not charging more than the federal allowable vaccine administration fee of $2122
bull The Centers for Medicaid and Medicare (CMS) establishes a maximum fee that sites can charge to non-Medicaid-eligible VFC patients in each stateterritory for vaccine administration Health Plans usually negotiate this fee with the site but Medicaid will not pay more
bull If a parent cannot pay the vaccine administration fee the patient cannot be turned away or reported to collections VFC-eligible children must be vaccinated regardless of their ability to pay
bull If the person with whom you are conducting the site visit does not know the exact fee charged to non-Medicaid VFC-eligible patients ask to speak to someone who can verify the exact amount
bull If they are charging more than $2122 for the administration fee ndash please contact MDH staff for help with addressing this situation
Resources bull Immunization Billing Guidance for MnVFC (wwwhealthstatemnusdivsidepcimmunizemnvfc billingtipshtml) or Immunization Billing Guidance for MnVFC Replacement Method Sites (www healthstatemnusdivsidepcimmunizemnvfcreplacementbillingtipsrephtml)
bull Section 2 of the MnVFC Policies and Procedures Manual
Page 24 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 3 Documentation Question 31
3 Documentation Eligibility Screening amp Documentation
Question 31 To answer the questions below the provider must clearly demonstrate the patient intake processReview a minimum of 10 records that contain an immunization visit within the last 6 ndash 12 months
Note to Reviewer Criteria for Record Selection 1) Record selection must be completely random and the provider must not know prior to the visit which
records will be reviewed 2) Patient must have been 0-19 years of age at the last visit (Note Records of 19-year-old patients may
allow you to see if VFC vaccines are being used beyond the allowable age) 3) Must review a mix of public and private-pay patients (if applicable)
A Does the provider have a process that ensures that patients are screened forVFC eligibility at each visit and that screening results are documented at each visit
Yes No [X] (If no skip question F)
B Does the providerrsquos process ensure that staff administering vaccine know which vaccine stock to select from prior to drawing the vaccine
Yes No [X]
C Number of records reviewed If fewer than 10 records are reviewed select the reason why Provider does not have 10 patient records with immunizations in last 12 months
D Do all records contain date of the immunization visit and patientrsquos date of birth Yes No [X]
E Do all records contain the patientrsquos specific eligibility status associated with thedate of the immunization
Yes No [X]
F Do any of the providerrsquos records contain any evidence that the patient received vaccine for which they were not eligible
Yes [X] No
Review CDC Requirement
VFC providers must screen for and document VFC eligibility at each immunization visit Documentation must include the date of the visit and the childrsquos specific eligibility category VFC providers must use screening results to ensure that only VFC-eligible children receive VFC vaccine and that administration fees are billed for as appropriate Eligibility status must be readily available to staff administering vaccine prior to selecting which vaccine stock to use
Goal of this question Ensure the site is screening for eligibility and documenting the eligibility category in the medical record
Review a minimum of 10 records from within the last 6-12 months where the patient received an immunization You must review a mix of public and private pay patients (if applicable)
Random selection is important If the staff have pre-selected records for review do not use and identify additional randomly selected records to review
Helpful information bull Discuss upgrading the electronic health record to make documentation of VFC eligibility screening a required field Documenting eligibility screening in the immunization field promotes better MIIC data
bull Q 31 B Sites using the replacement method of vaccine management only have one stock so you will answer ldquoYesrdquo to this question
Resources bull Patient Eligibility Screening Record on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfcformshtml)
bull Section 1 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 25
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 32
3 Documentation Vaccine Dose Documentation
Question 32 Review a minimum of 10 patient immunization records from the last six months (or 12 months ifnecessary) to assess compliance with documentation requirements set forth by Statute 42 US Code 300aa-25 (See note to reviewer below)
Note to Reviewer Criteria for Record Selection 1) Record selection must be completely random the Provider must not know prior to the visit which records
will be reviewed 2) Patient must have been 0-19 years of age at the last visit (Note Records of 19-year-old patients may allow
you to see if VFC vaccines are being used beyond the allowable age)
Records are Compliant if they Contain ALL the Below Elements
bull Address of clinic where vaccine was administered bull Publication date of VIS bull Name of vaccine administered bull Name of vaccine manufacturer bull Date vaccine was administered bull Lot number bull Date VIS was given bull Name and title of person who administered the
vaccine
A Number of records reviewed
B Number of records that contain ALL required documentation elements
If fewer than 10 records are reviewed select the reason why Provider does not have 10 patient records with immunizations in last 12 months
[X] Follow-up isrequired if one ormore records do not meet requirements
Goal of this question Assess whether the site is documenting all required information in each patientrsquos medical record for every vaccine dose administered in accordance with the National Childhood Vaccine Injury Act
Resources bull Section 6 of the MnVFC Policies and Procedures Manual bull National Vaccine Injury Compensation Program (wwwhrsagovvaccinecompensation)
Question 33
3 Documentation Record Retention
Question 33 Is the provider able to demonstrate (preferred) or clearly describe how they maintain historical VFCeligibility documentation for three years
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers are required to maintain all records related to the VFC program for a minimum of three years (or longer if requiredby state law) and upon request make these records available for review VFC records include but are not limited to VFC screening and eligibility documentation billing records medical records that verify receipt of vaccine vaccine ordering records and vaccinepurchase and accountability records
Goal of this question Make sure the site understands they are required to keep all MnVFC screening documentation for at least three years either electronically or on paper This information should be available to you at the time of the visit and future visits
Resource bull Section 7 of the MnVFC Policies and Procedures Manual
Page 26 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 34
3 Documentation Borrowing Documentation
Question 34 Discuss borrowing practices with the provider to answer the questions below
Note to Reviewer bull To be considered ldquofully documentedrdquo documentation for each borrowed dose must include thefollowing information
Vaccine type borrowed Date the dose was administered Stock used (VFC or private) Reason appropriate vaccine stock was not used Patient name and date of birth Date dose was returned to appropriate stock
A Did the provider state that they had borrowed any vaccines (whetherdocumented or not) since the last VFC Compliance Site Visit
Yes No (If no skip to question 36)
B Are there any doses for which there is no documentation (ie provider hasindicated that doses were borrowed but cannot verify how many or why)
All doses are documented Some doses are not documented [X] No doses are documented [X] (if nodoses documented skip toquestion 36)
C Were all borrowed doses fully documented (See Note to Reviewer above) Yes No [X]
D Were all borrowed VFC doses either replaced or an order submitted to replacethe doses Yes No [X]
Review CDC Requirement
VFC providers are expected to maintain an adequate inventory of vaccine for VFC and non-VFC-eligible patients It is theresponsibility of the VFC provider to appropriately schedule and place vaccine orders VFC providers must also rotate stock to ensure timely use of short-dated vaccines Borrowing of vaccine between private and public inventories must be a rare unplanned occurrence and cannot serve as a replacement system for a VFC providerrsquos privately purchased vaccine inventory All instances ofborrowing must be properly documented reported and replaced
Goal of this question Assess vaccine accountability by verifying that children are receiving vaccine from the appropriate stock
Borrowing is when a fully insured child receives a dose of MnVFC vaccine or a MnVFC-eligible child receives a dose of private vaccine This should be a rare unplanned occurrence The site must document any borrowing of vaccine between stocks ideally on the VFC Borrowing Report Form If they are not currently using the form review it with them and encourage them to post it close to their vaccines It does not need to be sent to MDH but should be kept for 3 years and filed with their MnVFC documents to be reviewed whenever they have a regular or unscheduled (unannounced) site visit
Helpful information bull Understand and report on staffrsquos verbal (ie anecdotal) accounts of borrowing obtained during the visit Often sites do not know that what they do is considered borrowing or they think borrowing is acceptable and documentation isnrsquot needed so long as those vaccines are eventually replaced
bull Since sites using the replacement method only have one stock of vaccine they very rarely borrow bull This question asks for future follow-up in 6 months Make a note on your calendar and ask them to send you a copy of their borrowing reports for the previous 6 months with documentation of doses borrowed and replaced We will remind you if we donrsquot hear from you at the 6 month time frame Complete the Follow-up Form and attach the borrowing form
Resources bull Vaccine Borrowing Report on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfc formshtml)
bull Section 10 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 27
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 353 Documentation Borrowing Reasons
Question 35 Based on your discussion with the provider and a review of borrowing reports document the dosesborrowed for each reason and answer the questions below
Note to Reviewer bull Short-dated vaccines are doses that are likely to expire before they can be used bull Exchanging short-dated vaccines should only occur in practices that have a small number of private
patients
A Reasons for Borrowing a VFC Dose (Enter the number of _____ Private vaccine shipment delay (order placed on time but delay in shippingreceipt)
vaccine doses borrowed for each
reason in the spaces
_____ Private vaccine not useable on arrival (vials broken temperature monitor out of range) _____ Ran out of private vaccine between orders (provider orders not placed on time) [X]
provided) _____ Short-dated private dose was exchanged with VFC stock _____ Accidental use of VFC dose for a private patient (human error) _____ Replacement of private dose with VFC when insurance plan did not cover vaccine _____ OtherDocumented dose did not include reason for borrowing [X]
(Explanation Required) Reasons for Borrowing a Private Dose _____ VFC vaccine shipment delay (order placed on time but delay in shippingreceipt) _____ VFC vaccine not useable on arrival (vials broken temperature monitor out of range) _____ Ran out of VFC stock between orders (provider orders not placed on time) [X] _____ Short-dated VFC vaccine dose was exchanged with private dose _____ Accidental use of a private dose for a VFC-eligible patient (human error) _____ OtherDocumented dose did not include reason for borrowing [X]
(Explanation Required)
B Enter date range for instances of borrowing reviewed in the borrowing report Note If ldquoDate of earliest instancerdquo is not available use the date of the last VFC Compliance Visit If ldquoDate of last instancerdquo is not available use the date of thecurrent VFC Compliance Visit
Date of earliest instance
Date of last instance
C Does borrowing appear to be a routine practice Note To determine whether borrowing is a routine practice assess frequency of and repeating reasons for borrowing Examples Frequent accidental use of incorrect stock exchanging short-dated vaccines or issues with ordering and shipment
Yes [X] No
Goal of this question Determine the reasons why the site is borrowing vaccine
If sites are using the Vaccine Borrowing Report review the reasons for borrowing to help document borrowed VFC andor private doses If they have not been documenting borrowing on this report (or any other form) estimate their borrowing practices If you do not know the date range for their borrowing use the last site visit date to the current visit date The use of ldquootherrdquo as the reported reason for borrowing should be rare if ever and would require explanation and follow up
Helpful information bull Look to see if they routinely maintain insufficient amounts or types of vaccine to support their public and private patients that leads to borrowing
bull Pay attention to borrowing cases documented as ldquoaccidentalrdquo Repetitive accidental borrowing may indicate an issue with ordering processes or insufficient staff training
bull Borrowing is not a place to document wasted or lost doses bull The time period of the borrowing may give you clues about the root cause Were the borrowed doses concentrated in a short period or spread out across several months or a year Are all vaccine types being borrowed or just one
bull If borrowing seems to be an issue discuss vaccine management ordering procedures
Resources bull Vaccine Borrowing Report on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfc formshtml)
bull Section 10 in the MnVFC Policies and Procedures Manual
Page 28 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 36
3 Documentation Vaccine Management Plan
Question 36 Physically review the providerrsquos Vaccine Management Plan to answer the question below
A Does the provider have a Vaccine Management Plan Yes No [X] (If no skip to question 37)
B Does the plan list the current Immunization Manager Vaccine Coordinator andback-up
Yes No [X]
C Does the plan address proper vaccine storage and handling practices Yes No [X]
D Does the plan specify vaccine receiving procedures Yes No [X]
E Does the plan contain procedures for what to do with vaccine in the event of an emergency
Yes No [X]
F Does the plan contain procedures for vaccine ordering Yes No [X]
G Does the plan address inventory control (example stock rotation) Yes No [X]
H Does the plan address how to handle vaccine wastage Yes No [X]
I Does the plan address staff training and documentation on vaccine managementstorage amp handling
Yes No [X]
J Does the plan contain a review date that falls within the last 12 months Yes No [X]
K Has the plan been signed by the individual responsible for its content Yes No [X]
Review CDC Requirement
VFC providers must develop maintain and implement a Vaccine Management Plan for routine and emergency vaccinemanagement The plan must contain the current Vaccine Coordinator and back-up proper storage and handling practicesshipping and receiving procedures emergency procedures procedures for vaccine ordering inventory control (eg stock rotation)how to handle vaccine wastage and staff trainingdocumentation on vaccine management storage and handling The plan must bereviewedupdated annually or more frequently if changes occur A ldquoreview daterdquo and signature are required on all plans in order tovalidate that they are current
Goal of this question Evaluate the sitersquos plan for vaccine management It is especially important that they have a plan for emergency management of their vaccine in the case of equipment failure or power outage Encourage all sites to read and sign the MnVFC Policies and Procedures Manual and complete the emergency plan or be able to show you a plan of their own
If the provider is not able to physically show you the plan at the time of the visit or if the recorded review date is not within the last 12 months you must mark that this requirement is unmet The Vaccine Management Plan is important in times of emergency and it should be easy to access by any staff member at any time Encourage them to post the plan and put a copy with the packing supplies
Helpful information bull Encourage the site to fill in the ldquoImmunization Managerrdquo and ldquoVaccine Coordinatorrdquo fields in the
MnVFC Policies and Procedures Manual for their own referencebull The emergency plan in the manual can be reviewed from last year and included in this yearrsquos manual (with an updated signature and date) if there have not been any changes
bull If information in the plan is outdated site staff will not be well equipped to safely manage vaccines in the event of a power-outage or other emergency situation
bull If their institutional policy is only reviewed and updated every 3-4 years (as many are) the staff may need to sign the MnVFC Polices and Procedure Manual to meet this requirement
Resource Routine Vaccine Management Plan and Emergency Vaccine Management Plan in the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 29
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 37
3 Documentation VIS amp VAERS
Question 37 Review the providerrsquos Vaccine Information Statements (VISs) and discuss providerrsquos VAERS process toanswer the questions below
A Does the provider have readily available up-to-date VISs for all ACIP-recommendedvaccines relevant to the populations it serves
Yes No [X]
B Does the provider make a VIS available for patientsparents before eachvaccination
Yes No [X]
C Does the provider know how and when to report clinically significant adverseevents using VAERS
Yes No [X]
Review CDC Requirement
VFC providers are required to distribute the current Vaccine Information Statements (VIS) each time a vaccine is administered and maintain records in accordance with the National Childhood Vaccine Injury Act (NCVIA) which includes reporting clinicallysignificant adverse events to the Vaccine Adverse Event Reporting System (VAERS) For a list of current VISs visit CDCrsquos Vaccine Information Statements (httpwwwcdcgovvaccineshcpvis) website
Gal of this question Ensure the site has the most current VISs and is giving them to each patientparent before administering the vaccine in compliance with the federal law Parents must be educated about the vaccine their child will receive and be aware of possible contraindications and side-effects in order to make well-informed decisions about their childrsquos health
Helpful information bull Ask to see the sitersquos VISs to determine if they have an active protocol for giving VISs to parents Review to make sure they are current Ask if they know where and how to report vaccine adverse events
Resources bull Section 3 in the MnVFC Policies and Procedures Manual bull CDC Vaccine Information Statements (wwwcdcgovvaccineshcpvisindexhtml) Site may sign up for email updates for the current list of VIS publication dates for the most up-to-date version
bull IAC Itrsquos Federal Law You must give your patients current Vaccine Information Statements (wwwimmunizeorgcatgdp2027pdf)
bull VAERS (httpsvaershhsgovindex)
Question 38
3 Documentation Anaphylaxis protocol
Question 38 Does the site have an anaphylaxis protocol which is clearly posted near the emergency kit
Answers (Choose one)
Yes No [X]
Review CDC Requirement
An anaphylaxis protocol must be clearly posted in the area where vaccines are administered
Goal of this question Make sure site is prepared for a severe allergic or anaphylactic reaction to a vaccine
Resources bull Section 11 in the MnVFC Policies and Procedures Manual bull IAC protocols Child and Teens (wwwimmunizeorgcatgdp3082apdf) and Adults (wwwimmunize orgcatgdp3082pdf)
Page 30 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
i
i i i - li i i i i i l
Section 4 Storage amp Handling Per Unit The goal of this section is to assess vaccine storage
2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet practices in each unit at the site MnVFC PIN ___________________
The 2017 MnVFC Storage amp Handling Per Unit Answer Sheet is a worksheet to document the answers to the questions in this section for each unit (combination or stand-alone) Fill in the answers to the questions in Section 4 on the answer sheet not in the questionnaire
The answer sheet has an abbreviated form of each question If you need further information on that question refer back to the full questionnaire Also if you find an area where the site is not meeting the requirements you will need to go back to that question on the 2017 MnVFC Site Visit Questionnaire to complete ldquoActions if Non- compliantrdquo section including the root cause analysis and follow-up sections If there is a problem in more than one unit make a note on the questionnaire which unit you are referring to in the Notes section
Important You must fully assess any unit that may be used to store VFC vaccines even if there are no VFC vaccines there on the day of the visit If there are no vaccines and the site is not documenting twice a day temperatures discuss the need to ensure the unit is maintaining stable temperatures by monitoring for one week before placing vaccines in the unit
Quest on number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
for the freezer and e co umn
Temperature Monitoring Dev refr gerator f the un
ce Quest ons Quest ons 4 3 4 7 must be answered separate y t s a combo Be sure to document responses n the appropr at
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
44D Data downloaded and reviewed routinely (eg weekly)
Yes No [O]
Yes No [O]
45A Certificate of Calibration Testing Yes No [X]
Yes No [X]
45B Date of calibration
45C Date certificate expires [X] Follow-up is required if expired [X] Follow-up is required if expired
45D Certificate contains all necessary items
Yes No [X]
Yes No [X]
46 Probe properly placed Yes No [X]
Yes No [X]
47A Two temperature readings per day
Yes No [X]
Yes No [X]
47B Time date and name (or initials) for each reading
Yes No [X]
Yes No [X]
47C Current temperature and minmax temperatures (if
Current ________deg Minimum ________deg Maximum _deg
Current ________deg Minimum ________deg Maximum _deg
Sections 5 and 6 contain questions about storage and handling site wide and inventory It is helpful to keep those questions in mind as you assess the individual storage units Think about dorm-style units expired vaccine vaccine supply room for vaccine stocking all the recommended vaccines and separation of stock if appropriate
NOTE The sections that follow require reviewers to validate responses by looking at vaccine storage units temperaturemonitoring equipment and the vaccine inventory inside a unit bull For section 4 use a separate Storage amp Handling Per Unit Answer Sheet for each unit to document the findings (combination
units using both sections can be documented on the same answer sheet) bull When an unmet requirement is identified return to this questionnaire to complete the ldquoActions if Non-compliantrdquo section for
that question bull After you complete one answer sheet for each unit return to the questionnaire to complete sections 5 and 6 using information
you gathered while assessing the units The questions in sections 5 and 6 (Storage amp Handling Site-Wide and Inventory) are notunit-specific but do require that the response be based on a thorough assessment of all the providersrsquo units
4 Storage amp Handling Per Unit
Description On the Storage amp Handling Per Unit Answer Sheet place a name that will allow you or someone else from your program to easily identify this unit in the event of follow-up We recommend using Brand + Location(example Samsung - Room 123) Save each Storage amp Handling Per Unit Answer Sheet with the Brand + Location in the file name
(example SamsungRoom123doc)
IPI Advisor Manual | February 2017 Page 31
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 41
4 Storage amp Handling Per Unit Storage Unit Build amp Use
Question 41 Below select the build and use of the vaccine storage unit you are assessing
Note to Reviewer Dorm-style units Do not add dorm-style units here Dorm-style units will be addressed in section 5 Units storing only private stock You must review these storage units even if they contain only private stockat the time of the visit because that vaccine could be administered to VFC patients
A What type of unit is this A Stand-alone B Combination
B Select use if stand-alone A Freezer B Refrigerator
Select use if combination A Use both sections to store vaccine B Use freezer section only to store vaccine C Use refrigerator section only to store vaccine
Goal of this question Identify the unit you are evaluating The description asks you to create a unique name for this unit so that you will be able to identify the same unit in future site visits Put this description on the top of the answer sheet (ie make and location)
Helpful information bull A stand-alone unit is either a refrigerator or a freezer It does not have both sections in the unit bull If there is a combination unit note if the site uses both the refrigerator and freezer or only one section of the unit to store vaccines CDC does not recommend the use of either section or the freezer section only of combination household units
bull If your site utilizes the separate stock method of vaccine management you must review storage units even if they contain only private stock at the time of the visit because there is a chance that those vaccines could be administered (borrowed) to VFC-eligible patients
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-
Question 424 Storage amp Handling Per Unit CDC Recommended Storage Units
Question 42 Below document the grade of the vaccine storage unit you are assessing
Note to Reviewer Pharmaceutical Also called ldquopurpose-builtrdquo these units are designed by the manufacturer specifically tostore vaccines or other biological materials Commercial Although usually intended to store food and beverages commercial units are often larger and more powerful than the household units found in most homes Though these units are intended to meet thehigher demands of larger facilities these units are not specifically built for the storage of biologicalmaterials Household (non-commercialdomestic) These units are usually smaller than commercial units and areintended for use in small offices and in homes ndash typically for food storage However just like commercialunits they are not designed specifically for the storage of biological materials Such units are usually available in common home supply stores
Answers (Choose one)
Select grade A Pharmaceutical B CommercialHousehold
[O] CDC does not recommend the use of both sections or the freezer section only of combination commercialhousehold units
Review CDC Recommendation
CDC recommends the following vaccine storage unit types (in order of preference) pharmaceutical grade stand-alone orcombination units (preferred) householdcommercial stand-alone units householdcommercial combination units using therefrigerator section only
Goal of this question Assess the grade and type of each storage unit bull Pharmaceutical grade units may be stand-alone or combination units that are often metal may have glass in the door for viewing inside often have an external digital temperature display and are manufactured by medical companies
bull Commercial or household units often look like your kitchen appliance have vegetablemeat drawers in the unit and are manufactured by household appliance companies
bull Occasionally you might find a medical grade unit which is usually a commercialhousehold unit with a lock and 3-prong plug These are still considered household units because of their ability to maintain proper temperatures and air flow Studies show that household stand-alone units are better able to maintain consistent temperatures than their combination counterparts Combination household units used to store vaccine in both sections of the unit is no longer recommended and may be prohibited in the future Combination household storage units that are having difficulty maintaining a cold enough freezer temperature and a warm enough refrigerator temperature should be replaced or a separate stand-alone freezer should be purchased
For frozen vaccines the most cost effective solution is for the site to purchase a small stand-alone freezer The site may need time to budget for a stand-alone storage unit
Resources bull Replacing Combination Household Units Tip Sheet on IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml)
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The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 434 Storage amp Handling Per Unit Temperature Monitoring Device in the Unit
Question 43 Determine whether there is a temperature monitoring device in this section of the storage unit andanswer the questions
A Is there a temperature monitoring device in this section of thestorage unit
Yes No [X] (If no skip to question 47)
B Who is responsible for supplying the temperature monitoring device in this section of the storage unit Provider
Review CDC Requirement
Certificates of calibration testing provide confidence that the temperature monitoring device is measuring temperaturesaccurately All units storing VFC vaccines must have a calibrated temperature monitoring device with a current and valid certificateof calibration testing All certificates must contain modeldevice name or number serial number date of calibration testing (report or issue date) and Instrument Passed testingInstrument in Tolerance (Recommended uncertainty = +-05ordm C (+-1ordm F))
Goal of this question Assess whether there is a temperature monitoring device in the unit If the unit is not being monitored at all call MDH at 651-201-5522 for guidance
Helpful information bull This question does not ask whether the temperature monitoring device is working or the characteristics of the device These issues will be addressed later in the questionnaire
bull For part B the provider is always responsible for supplying the temperature monitoring device Even if their thermometer or data logger was originally from MDH it is their responsibility to ensure it is functional and calibrated
Resources bull Section 8 in the MnVFC Policies and Procedures Manual
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-
Question 444 Storage amp Handling Per Unit CDC Recommended Temperature Monitoring Device
Question 44 Assess the temperature monitoring device in this section of the storage unit to answer the questionsbelow
A Is the temperature monitoring device a continuous monitoring and recordingdevice (eg data logger)
Yes No [O] (Skip D)
B Does the temperature monitoring device have a probe in buffered material Yes No [O]
C Does the temperature monitoring device have a digital display that can beeasily read from the outside of this unit
Yes No [O]
D Is data downloaded and reviewed routinely Yes No [O]
Review CDC Recommendation
As of Jan 1 2018 all VFC providers must use continuous temperature monitoring devices (eg data loggers) to monitor vaccinesthat will be administered to VFC-eligible children Routine review and accessibility of temperature data is critical for determining whether vaccine has been properly stored and for assessing usability of vaccine that was involved in a temperature excursion Tomeet VFC Program requirements the device must also be equipped with bull A temperature probe bull An active temperature display that can be easily read from the outside of the unit bull The capacity for continuous monitoring and recording capabilities where the data can be routinely downloaded
The following are additional recommended features for these devices bull Alarm for out-of-range temperatures bull Current minimum and maximum temperatures display bull Low battery indicator bull Accuracy of +- 1degF (05degC) bull Memory storage of at least 4000 readings bull User programmable logging interval (or reading rate) recommended at a maximum time interval of every 30 minutes bull Use of a probe that best reflects the temperature of the vaccine (such as a buffered probe)
Goal of this question Assess the temperature monitoring device in the storage unit Note that these are all recommendations not requirements at this time
This is a great teaching opportunity for sites who do not currently have a continuous temperature monitoring device Beginning Jan 1 2018 all units that store MnVFC vaccine will be required to have a continuous temperature monitoring device (ie a data logger or a continuous temperature monitoring system) Unlike a minmax thermometer a continuous temperature monitoring device provides detailed information on all temperatures recorded at pre-set intervals For excursions it can provide information on when a temperature went out-of-range for how long and what the temperatures were This is essential information that vaccine manufacturers need to know to assess the viability of the vaccine following an excursion
Helpful information bull Sites are required to monitor and record temperatures twice daily however temperature excursions can easily occur in the 12 hours or longer between readings Continuous temperature monitoring can help manufacturers determine vaccine viability
bull Continue to encourage sites to document and evaluate minimum and maximum temperatures the storage unit reached since the last reading and respond appropriately to out-of-range temperatures
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The 2017 MnVFC Site Visit Paperwork Chapter 4
bull It is recommended that sites download and review data weekly Discuss with sites that reviewing temperature monitoring device data also includes responding appropriately if they identify out-of-range temps
bull There is sometimes confusion about the difference between a data logger and a continuous temperature monitoring system Here are some differences
Data Loggers Continuous Monitoring Systems Have an external display similar to thermometers May or may not have an external display Have a detachable probe Probe is usually attached to transmitter Need to be plugged into the computer or cradle to download information on a regular schedule
Wirelessly sends data to computer system
Create a file of data that needs to be saved on the computer
Data is stored within the system not a separate file
Doesnrsquot allow documentation of twice a day temperature checks in the file
May allow documentation of twice a day temperature checks within the system
More about the 2018 requirement for a continuous temperature monitoring device
Required Features bull The continuous temperature monitoring device must have Continuous monitoring and recording capabilities to track and record temperatures over time The capacity to routinely download temperature data to a computer (recommended at least weekly) or wirelessly transmit data Detachable probe in a bottle filled with a thermal buffer (eg bio-safe glycol) if the data logger needs to be detached in order to download data Active temperature display
Recommended Features bull MnVFC recommends continuous temperature monitoring devices with Alarm for out-of-range temperatures Accuracy within +-1degF (+- 05degC) Low battery indicator Display of current minimum and maximum temperatures Memory storage of at least 4000 readings User programmable logging intervals (eg the user can set how often the device records the temperature)
Note that these are all currently recommendations not requirements yet
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
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The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 45
Goal of this question Ensure the temperature monitoring device is properly calibrated The certificate of calibration testing means that the device has been tested and it is accurately measuring temperatures within established testing limits The certificate of calibration ensures that the device meets all the required components
Helpful information bull The provider is always responsible for having a current certificate of calibration (or copy) on-site
bull To be considered ldquovalidrdquo a certificate of calibration must contain these required elements Modeldevice name or number Serial number
4 Storage amp Handling Per Unit Certificate of Calibration Testing
Review CDC Requirement
Certificates of calibration testing provide confidence that the temperature monitoring device is measuring temperaturesaccurately All units storing VFC vaccines must have a calibrated temperature monitoring device with a current and valid certificateof calibration testing All certificates must contain modeldevice name or number serial number date of calibration testing (report or issue date) and Instrument Passed testingInstrument in Tolerance (Recommended uncertainty = +-05ordm C (+-1ordm F))
Question 45
Note to Reviewer
A
B
C
D
E
Review the certificate of calibration testing for the temperature monitoring device in this section of the storage unit and answer the questions below
bull How to determine certificate of calibration testing expiration date 1) Identify the certificate issuecalibration date 2) Apply the Immunization Program-required frequency for calibration testing Example If the
issuecalibration date is 12312013 and Immunization Program policy requires testing every twoyears the expiration date is 12312015
bull Certificates must include all of the below bull ModelDevice Name or Number bull Serial Number bull Date of Calibration Testing (Report or Issue Date) bull Instrument Passed testing (Instrument in Tolerance)
Is there a certificate of calibration testing for the temperature monitoring Yes device in this section of the storage unit No [X]
What is the date of calibration for the temperature monitoring device in this section of the storage unit
What is the certificatersquos date of expiration based on ImmunizationProgram policy (See note to reviewer to determine expiration date) [X] Follow-up is required if
certificate is expired
Does the certificate contain all the necessary items listed in the Note to Yes Reviewer No [X]
Who is responsible for supplying the current and valid certificate of Provider calibration for this temperature monitoring device
Date of calibration testing (report or issue date) Note If there is no expiration date the certificate expires 2 years from the date of calibration Whether the instrument passed or failed testing (or instrument in tolerancenot in tolerance)
bull Recommended element Documented uncertainty of +- 1degF [05degC]
If these elements are present the certificate is considered valid If the certificate contains information about the recommended element or the entity that issued the certificate that is helpful but not required
To determine if a certificate of calibration testing was issued by an appropriate entity check to see if the certificate indicates one or more of these items (this is the wording used to help sites evaluate if their calibration is accurate but is not required on the certificate itself to be considered valid)
bull Conforms to ISO 17025 bull Performed by an ILACMRA Signatory body accredited laboratory You can review this list of the ILAC MRA and Signatories (httpilacorgilac-mra-and-signatories)
bull Traceable to the standards maintained by NIST bull Meets specifications and testing requirements for the American Society for Testing and Materials (ASTM) Standard E2877 tolerance Class F (le 05 degC) or better
bull Includes reference to another acceptable accuracy validation method such as comparison to other traceable reference standards or tests at thermometric fixed points
Note CDC recommends that certifications be issued for the entire monitoring unit (detachable probe data logger etc) and not individual certificates for each component
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The 2017 MnVFC Site Visit Paperwork Chapter 4
For 45 E the provider is always responsible for supplying the current and valid certificate of calibration for a temperature monitoring device
bull Tip If the temperature monitoring device has a sticker on the back with the calibration date the site can usually call the company who calibrated the device and get a copy of the certificate if they donrsquot have one
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 46 4 Storage amp Handling Per Unit Probe Placement
Question 46 Is the probe properly placed in this section of the storage unit
Note to Reviewer ldquoProperlyrdquo means that the probe in a commercial or household unit is placed in a central area of the unitdirectly with the vaccines Probes should not be placed in the doors near or against the walls close to vents or on the floor of the unit The only allowable exemption related to this requirement is for providerswho have pharmaceutical storage units (built for vaccine storage) that have either (1) a built-intemperature monitoring device OR (2) a dedicated port for the probe that dictates the placement of theprobe
Answers (Choose one)
Yes No [X]
Review CDC Requirement
The probe must be placed in a central area of the section of the storage unit directly with the vaccines in order to properly measurevaccine temperature The probe should not be placed in the door near or against the walls close to vents or on the floor of theunit For pharmaceutical units with a built-in temperature monitoring device or a dedicated port for a probe that is not in thecenter of the section of the storage unit consult your Immunization Program for guidance on placement
Goal of this question Make sure the temperature monitoring device is in the best location to accurately measure the temperature of the vaccines stored in the unit
Helpful information bull The probe of the temperature monitoring device should be placed directly with the vaccines in the middle of the unit The ONLY allowable exception is for pharmaceutical storage units that have either a built-in thermometer or a dedicated port for the probe that indicates placement of the probe
bull Temperatures can vary within the unit especially household units bull Call MDH at 651-201-5522 if you have questions
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Guide (wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml)
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Question 474 Storage amp Handling Per Unit Temperature Documentation
Question 47 Review the temperature documentation over the past three months for this section of the storage unit todetermine whether the provider has a process in place for properly documenting temperatures twice aday Answer the questions below
A Are there two temperature readings recorded for this section of the storage unit per day
Yes No [X]
B Is there a time date and name (or initials) recorded for each reading Yes No [X]
C What is the current temperature and minmax temperatures (if available) inthis section of the storage unit Use the reviewerrsquos thermometer if the providerrsquos temperature monitoringdevice does not have a current valid certificate of calibration testing or the probe is not properly placed in this section of the storage unit
Current Temperature Minimum Temperature Maximum Temperature Fahrenheit Celsius
D Based on your review of the providerrsquos recent temperature documentationincluding the current temperature is this section of the storage unitmaintaining appropriate temperatures
Yes No [X] Not enough information [X]
Review CDC Requirement
Vaccines must be stored under appropriate temperatures as described in the package inserts at all times Acceptable temperature ranges vary by vaccine type and the range is 36deg F and 46deg F (2deg C and 8deg C) and for frozen vaccines the range is -58deg F and +5deg F (shy50deg C and -15deg C) Exposure to temperatures outside of those included in the package inserts could affect vaccine viability andultimately could leave children unprotected against vaccine-preventable diseases In order to maintain awareness of storage unittemperatures and ensure that vaccines are being stored at appropriate temperatures at all times VFC providers are required to monitor and document temperatures for all vaccine storage units at least twice a day Temperature documentation must contain (1) at least two temperature readings per day (2) the time and date of each reading and (3) the name (or initials) of the personwho assessed and recorded the readings CDC also recommends that VFC providers record the minimum and maximumtemperatures of each unit once each workday (preferably in the morning)
Goal of this question Ensure the temperature is being monitored twice daily is within the required range and documented correctly Use your thermometer to check the temperature if the sitersquos temperature monitoring devicersquos probe is not properly placed or there is not a current certificate of calibration Place your thermometer in the unit at the beginning of the visit to allow sufficient time to reach an accurate temperature The purpose of using your thermometer is to ensure the vaccine is being stored at the proper temperature not to ldquovalidaterdquo their reading
Question 47 D is an assessment question based on information you have learned during your visit You might answer ldquonot enough informationrdquo if the unit is new and they donrsquot have at least three months of data or if the unit is only used as overflow and they are inconsistent with temperature monitoring Mark ldquoNordquo if you have reason to believe the storage unit is not maintaining temperatures properly
Helpful information bull All sites must document temperatures twice a day every day the site is open even if they have a data logger or continuous monitoring system
bull Sites can document the information electronically with some continuous monitoring systems as long as it can show what the current temp is the date time and initials of the person checking ndash this needs to be someone at the site ndash not checking remotely or centrally for a large site or system The site must be able to produce these records during their site visit Reviewing these files can be a challenge due to large volumes and lots of paper
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Temperature Logs on Managing Vaccine (wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml)
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Question 484 Storage amp Handling Per Unit Temperature Excursions
Question 48 In the event that a temperature excursion(s) occurred in this unit within the last three months requestand review documentation of actions taken to determine whether the provider has a process for properlyaddressing excursions Answer the questions below
A Were vaccines in this unit exposed to out-of-range temperatures in the lastthree months (including today)
Yes No (If no skip to question 49)
B Did the provider quarantine and label vaccines as ldquoDo not userdquo Yes No [X]
C Did the provider place vaccine in a unit where it can be stored under properconditions if applicable
Yes No [X]
D Did the provider contact the Immunization Program to report theexcursion
Yes No [X]
E Was the manufacturer contacted for documentation supporting theusability of the vaccine
Yes No [X]
Review CDC Requirement
The provider must document all excursions and actions taken including the following (1) Quarantine and label vaccines as ldquoDO NOTUSErdquo (2) Place vaccines in a unit where they can be stored under proper conditions (3) Contact the Immunization Program to report an excursion and (4) Contact the vaccine manufacturer to obtain documentation supporting the usability of the vaccine
Goal of this question Address any out-of-range temperatures (temperature excursions) identified in reviewing the last three months of temperature logs or during the site visit If there were any out-of-range temperatures did the site respond appropriately to the situation This is a great opportunity to discuss what to do in the event of an excursion The Clinicians Storage and Handling Mishap Checklist is in the IPI Site Visit information folder and is a good review of the process
Helpful information bull Sites need to know that an excursion does not automatically mean that exposed vaccines are non-viable or unusable Exposed vaccines must be quarantined (marked ldquoDo Not Userdquo) and stored under proper conditions until they have received information from vaccine manufacturers regarding the viability of the vaccine
bull Sites must inform MDH when an excursion occurs
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Clinicians Storage and Handling Mishap Checklist (wwwhealthstatemnusdivsidepcimmunize ipivaxchklstpdf)
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Question 49
Goal of this question Ensure proper placement of vaccines in the storage unit
Note These are all recommendations (best practices) not requirements
Helpful information bull Store vaccine in the middle of the compartment two to three inches away from the coils walls floor and cold air vent The temperature near the floor and walls of the unit differs from that in the middle of the compartment and the cold air vent can freeze refrigerated vaccines
4 Storage amp Handling Per Unit Vaccine Placement
Question 49 Look inside the unit to answer the questions below
A Are vaccines placed in the middle of the unit with space between vaccinesand the sideback of the unit to allow cold air to circulate
Yes No [O]
B Are vaccines stored in their original packages Yes No [O]
C Are there water bottles (for refrigerators) or frozen water bottles (forfreezers) in the unit
Yes No [O]
D Are vaccines store in the doors vegetable bins under or near cooling ventsor on the floor of the unit
Yes [O] No
E Is food being stored in the unit Yes [O] No
Review CDC Recommendation
Vaccines should be stored in their original manufacturer (or CDC centralized distributor) packaging They should be placed in the middle of the unit with space between the vaccines and the sideback of the unit to allow cold air to circulate Vaccines SHOULD NOT be stored in the doors vegetable bins or floor of the unit or under or near cooling vents and there should not be any food inthe unit Water bottles (for refrigerators) or frozen water bottles (for freezers) should be placed throughout each storage unit inorder to (1) stabilize or extend temperatures during a power outage and (2) to serve as physical blocks preventing the placementof vaccines in areas of the unit that are at higher risk for temperature excursions (such as in doors vegetable bins floor ornearunder cooling vents)
bull Vaccines should be kept in their original packaging to Protect them from light Help prevent medication errors by making labels easier to read Provide a moisture barrier that serves as insulation in case of an out-of-range temperature power outage door left open or mechanical failure Simplify managing vaccine inventory
bull Store water bottles in the doors on the floor and near the cold air vent in the refrigerator and frozen water bottles in the freezer to help maintain a stable temperature if there is a power failure and when the door is opened frequently Too many water bottles in the door can prevent the door from closing tightly Mark water bottles ldquoDo Not Drinkrdquo
bull Do not store vaccine in the door or drawers of the refrigerator or freezer Vegetable bins and crisper drawers should be removed from refrigerators or used to store other medical supplies or water bottles
bull If vaccine is stored in a household combination refrigeratorfreezer The top shelf should not be used for storing vaccine because the cold air vent blowing from the freezer will freeze vaccine located there If you must use the top shelf of this type of unit place water bottles underneath the cold air vent to prevent vaccine from being stored there It is recommended that only the refrigerator be used for vaccine storage and a separate stand-alone freezer be used to store frozen vaccine
bull Must not store food or beverages in the refrigerator or freezer because frequent opening of doors can lead to temperature variations that may affect vaccine viability There is also a risk of contaminating vaccines
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Guide (wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml) bull Vaccine Storage Tip Sheet on IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml)
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The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 4104 Storage amp Handling Per Unit Disconnection from Power Source
Question 410 Ask the provider to demonstrate what measures are taken to ensure that vaccine storage units are notaccidentally physically disconnected from the power supply Which of the following describes the measure(s) taken on this unit
Note to Reviewer bull Large hospitals and healthcare systems may not have the ability to demonstrate labels on plugs or circuitbreakers In such cases verify that the practice has a comprehensive policy and standard operatingprocedures in place to prevent the vaccine storage unit from being physically disconnected from thepower supply
bull While back-up generators may ensure power to the overall facility this question ONLY addresses thevaccine storage unit being accidentally disconnected from the power source either through the plug orthe circuit breaker
Answers A ldquoDo not disconnectrdquo labels on the plug (Choose all that B ldquoWarningrdquo label on the circuit breaker box
apply) C Hard-wired (ie built-in) and has a ldquoDo not disconnectrdquo label on thecircuit breaker box D Hospital or large health care system with a comprehensive written policyand standard operating procedures detailing measures taken to preventvaccine storage units from being accidentally disconnected from the powersupply E No acceptable measures for preventing accidental disconnection frompower supply [X]
[X] The response is non-compliant if only A only B or E is selected
Review CDC Requirement
VFC providers must take steps to protect the power source for all vaccine storage equipment by means of having clear warninglabels on both the plug and the circuit breaker associated with all vaccine storage units Large hospitals and healthcare systems canmeet this requirement by demonstrating that they have comprehensive policies and standard operating procedures to preventvaccine storage units from being physically disconnected from the power supply
Goal of this question Decrease the chance that a vaccine storage unit will be accidently unplugged or power will be turned off while vaccine is in the unit This question addresses only what measures the site has taken to ensure the storage unit is not physically disconnected from its power source
If the site uses labels on the plugs and circuit breakers perform a visual inspection to assess whether the way the stickers are positioned make it clear and obvious to anyone that these units are not to be disconnected
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Do Not Unplug and Warning stickers are included in the folder or available to order on the For
Professionals Order Form (wwwhealthstatemnusdivsidepcimmunizeordermathtml)
Note Once you have completed the 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet for each unit return to the questionnaire to complete sections 5 and 6
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-
- -
Section 5 Storage amp Handling Site-Wide Question 51
5 Storage amp Handling Site Wide Discussion of Cost amp Quantity of Vaccine
Question 51 Have a discussion with the provider about the cost and quantity of VFC vaccines they are responsible for annually Address the points listed in the note to reviewer below
Note to Reviewer bull Vaccine Shipped (Required) Share the cost of VFC vaccines shipped to the provider in the last calendaryear to make sure the provider understands the contribution made by the VFC Program to their practiceFor new providers who do not have ldquocalendar yearrdquo data share either the actual cost of their currentinventory or use the cost of 10 VFC doses of each of the ACIP-recommended vaccines (approximately $7000) to help estimate their annual cost
bull Storage amp Handling (Required) Make sure the provider understands the cost of vaccines for which they are responsible when they make decisions about purchasing recommended vaccine storage and temperature monitoring equipment
Answer I have discussed with the provider the cost and quantity of vaccines ordered in the previous calendar year
Goal of this question Inform sites of the quantity and value of vaccines that they receive as part of the MnVFC program Providers often donrsquot realize the value of the vaccine in their unit This information is included on your clinic list and on the one page site-specific information
Helpful information bull This discussion must occur and the box on the questionnaire must be checked bull If there isnrsquot actual vaccine value information available tell the site that one vaccine order that includes a box of each of the ACIP recommended vaccines costs approximately $7000
bull MDH may not have specific information for individual sites if they receive vaccine from a central warehouse or pharmacy For those sites MDH will give you numbers for the whole system so you can discuss system wide data as appropriate If individual site information is also included it is usually just varicella-containing vaccines that must be shipped directly to the site
Question 52
5 Storage amp Handling Site Wide Dorm Style Units
Question 52 Determine whether the provider has any dorm-style units on site and answer the questions below
Note to Reviewer A dormitory-style refrigerator is a unit that has both refrigerator and freezer compartments behind a singleexterior door Dorm-style units also have an evaporator plate (cooling coil) which is usually located insidean icemaker compartment (freezer) within the refrigerator
A Does the provider have any dorm-style units that are used at any time tostore vaccines
Yes [X] No (Skip to question 53)
B Does the provider have sufficient space in existing compliant vaccinestorage units to store all vaccines without use of the dorm-style unit at any time
Yes No [X]
Review CDC Requirement
Dorm- and bar-style units are prohibited for vaccine storage Vaccines stored in dorm-style units are considered non-viable and must be returned to the centralized distributor CDC recommends the following vaccine storage unit types (in order of preference)pharmaceutical grade stand-alone or combination units (preferred) householdcommercial stand-alone unitshouseholdcommercial combination units using the refrigerator section only
Goal of this question Ensure no vaccine is stored in dorm-style units even for short periods of time Encourage them to label any units ldquoNo Vaccine Storage Allowedrdquo Vaccine stored in these units is considered non-viable If a site is using a dorm-style unit call the MnVFC program (651-201-5522)
Resource Section 8 in the MnVFC Policies and Procedures Manual
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-
Question 535 Storage amp Handling Site Wide Storage Unit Space Availability
Question 53 Does the provider have sufficient room across storage units to store current stock as well as anyadditional stock acquired during peak season without overcrowding
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have sufficient storage space to accommodate vaccine stock at the busiest time of year without overcrowding
Goal of this question Ensure that sites have sufficient space in their units to maintain vaccines at the busiest time of year Overcrowding of vaccine limits air circulation and affects the unitrsquos ability to maintain stable temperatures
Helpful information bull Look for signs of overcrowding such as vaccines that are pushed up against the wall bins that are overflowing or storage units that are full during non-peak seasons
Discuss immediate actions if the unit is overcrowded Move some of their vaccines order less vaccine more frequently (once per month preferably) andor purchase another storage unit for overflow
Resource bull Section 8 MnVFC Policy and Procedure Manual
Page 44 IPI Advisor Manual | February 2017
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-
Question 545 Storage amp Handling Site Wide Expired Vaccines
Question 54 Look in each unit Are there expired vaccines in any of the vaccine storage units at this site
Answers (Choose one)
Yes [X] No
Review CDC Requirement
Vaccines should be rotated weekly and when a new shipment comes in so that longer-dated vaccines are stored behind shorter-dated vaccines If vaccines expire they can no longer be stored in the same storage unit with viable vaccines They must be placedin a container or bag clearly labeled ldquoDo not userdquo and separated from viable vaccines to prevent inadvertent use Expired vaccinemust be returned to the centralized distributor within six months of expiration
Goal of this question Ensure there is no expired vaccine in any storage unit
Helpful information bull Sites can prevent their stock from expiring by rotating vaccines every week andor when a new shipment arrives Longer-dated vaccines are stored towards the back of the unit and shorter-dated vaccines are up front
bull Pay attention to vaccines that expire within the next three months Consider transferring vaccine that will expire soon to another MnVFC-enrolled site that will use the vaccine preferably a site close by It is the transferring sitersquos responsibility to arrange the transfer of the vaccine Be sure to complete the MDH Vaccine Transfer Record form and send it to MDH If they are having difficulty finding a location to accept vaccine contact MDH
bull This is a great opportunity to educate sites about the MDH Nonviable Vaccine Form and the process for returning vaccine The VFC program does get some credit for taxes and fees on vaccine that is returned to the distribution center
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MDH Nonviable Vaccine Form and MDH Vaccine Transfer Record on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfcformshtml)
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The 2017 MnVFC Site Visit Paperwork Chapter 4
- -
-
Question 555 Storage amp Handling Site Wide Back up Thermometer
Question 55 Does the provider have a readily available back-up thermometer with a current and valid certificate ofcalibration testing
Note to Reviewer ldquoReadily availablerdquo means that the thermometer is available to perform twice-a-day monitoring for a unit asrequired CDC recommends that the back-up thermometer be maintained on site
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have a readily available back-up thermometer with a current and valid certificate of calibration testing Toprevent the certificates of calibration testing of the primary and back-up thermometers from expiring at the same time the date of calibration testing (or issue date) of the back-up thermometer should be different from the date of calibration testing (or issue date) of the primary thermometer As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meetsVFC program requirements
Goal of this question Ensure sites have one calibrated back-up thermometer onsite that is readily available in the event that the temperature monitoring device in unit fails transportation of vaccine is needed or there are other unexpected circumstances
Helpful information bull As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meets VFC Program requirements
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 56 5 Storage amp Handling Site Wide Preparation of Vaccine
Question 56 When does this provider prepare vaccine for administration to the patient
Note to Reviewer For mass vaccination clinics if one type of vaccine is offered providers may pre-draw up to 10 doses Ifusing pre-filled syringes pre-drawing also means activating the syringe by removing the needle guard orattaching a needle
Answers (Choose all that
apply)
Prepare dose immediately before administration Pre-draw doses for upcoming patients (in a regular clinicpractice) [O] Pre-draw up to 10 doses (in a mass-vaccination clinic) Pre-draw more than 10 doses (in a mass-vaccination clinic) [O] Other [O]
Review CDC Recommendation
CDC recommends preparing vaccines immediately prior to administration in order to assure viability of vaccine and prevent vaccinewastage Vaccines that are not administered immediately are at risk of exposure to temperatures outside of the required rangewhich can affect vaccine viability and ultimately can leave children unprotected against vaccine-preventable diseases
Goal of this question Discuss proper timing and preparation of vaccine(s) for administration These are recommendations not requirements
Helpful information bull Educate staff on the importance of preparing vaccine immediately before administration Pre-drawing of vaccines may lead to concerns related to vaccine viability potency sterility and wastage
Page 46 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 6 Inventory Question 61
6 Inventory Inventory Comparison
Question 61 Visually inspect storage units to determine if existing supply of vaccines proportionately mirrorspopulations served Choose the most accurate statement below
Note to Reviewer bull CDC recommends that providers maintain a four-week supply of inventory bull For this question do not take into account vaccine types that the provider does not order Here simply
make sure that overall the vaccines in the providerrsquos storage units are available in sufficient amounts toserve their patient population
Answers (Choose one)
The current vaccine inventory proportionately reflects the populations identified Only public stock is insufficient [X] Only private stock is insufficient [X] Both public and private stock are insufficient [X] Site uses the replacement method but does not appear to have enough vaccine for their population [X] Other [X]
Review CDC Requirement
VFC providers must order and stock routine vaccines in accordance with their patient population in order to prevent missedvaccination opportunities Having sufficient amounts of all stocks prevents the inadvertent use of VFC vaccines for non-VFC-eligiblepatients and vice versa
Goal of this question Assess whether the site is ordering appropriate quantities of vaccine for the population they serve at their site
Helpful information bull If the site sees 30 percent private-pay patients and 70 percent VFC the stock in their storage units should reflect that proportion If you donrsquot know you can ask the site about their population
bull This is meant to be a general assessment so in a big site if they have only a small amount of vaccine that may indicate an issue with vaccine management
bull CDC recommends smaller more frequent orders (ie monthly) rather than large orders to minimize the amount of vaccine loss if an incident occurs during shipment or in the storage unit Sites should not order more frequently than once a month
bull Sites using the replacement method will only have one stock but it should appear to be large enough for their population
bull Only assess the vaccine types that the site currently stocks in their unit We know there are sites that do not offer all ACIP-recommended vaccines for various reasons That issue will be addressed in question 62
IPI Advisor Manual | February 2017 Page 47
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 626 Inventory ACIP Recommended Vaccines
Question 62 Review providerrsquos current inventory to answer the questions below
A Does the provider offer all routine ACIP-recommendedvaccines for their patient population
Yes (Skip to question C) No [X] Offers all except varicella because direct ship ofvaccine is unavailable from manufacturer
B Which routine vaccines are NOT being offered DTaP Hepatitis A Hepatitis B HIB HPV Influenza Meningococcal
MMR Pneumococcal Polio Rotavirus TdapTd Varicella
C According to Immunization Program Policy does theprovider make accessible all non-routine ACIP-recommended vaccines for those VFC patients whomeet the criteria for receiving them
Yes (Skip to question 63) No [X]
D Which non-routine vaccines are NOT being offered Pneumococcal polysaccharide vaccine (PPSV23) Meningococcal Group B (MenB) Other
Review CDC Requirement
VFC providers agree to comply with immunization schedules dosages and contraindications that are established by the Advisory Committee on Immunization Practices (ACIP) for the vaccines identified and agreed upon in the Provider Agreement UNLESS bull In the VFC providers medical judgment and in accordance with accepted medical practice the VFC provider deems such
compliance to be medically inappropriate for the child bull The particular requirements contradict state law including laws pertaining to religious and other exemptions The VFC program entitles children to the following vaccines DTaP Hepatitis A Hepatitis B HIB HPV Influenza MeningococcalMMR Pneumococcal Polio Rotavirus TdapTd and Varicella VFC providers are also required to ensure that VFC-eligible children have access to non-routine vaccines as needed
Goal of this question Assess if the site is offering all the ACIP-recommended vaccines for the population they serve and these vaccines are in stock on the day of the visit It is important that every MnVFC-eligible child that comes to a providerrsquos office for an immunization is vaccinated
Helpful information bull The Advisory Committee on Immunization Practices (ACIP) is a group of medical and public health experts that develops recommendations on how to use vaccines to control diseases in the United States
bull Specialty providers are not required to offer all routine vaccines but should provide the vaccines appropriate for their population
bull If the site does not offer all routine ACIP-recommended vaccines appropriate for their population check the ldquoNordquo box in Part A then check the appropriate box(es) in Part B for any vaccines not offered Please contact MDH as this situation offers us the opportunity to provide education to the site
bull For non-routine vaccines they must either be in stock or the site must have an alternative protocol in the routine management plan that ensures these children have access when applicable
Resources bull IAC Diseases and Vaccines (wwwimmunizeorgvaccines) bull CDC Advisory Committee on Immunization Practices (ACIP) (wwwcdcgovvaccinesacipindexhtml)
Page 48 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 636 Inventory Separation of Stock
Question 63 Observe how the provider differentiates stock in each storage unit to answer the questions below
A Is it clear which vaccines belong to public stock andwhich belong to private stock
Yes No [X] Not applicable replacement site
B Is it clear which vaccines belong to VFC stock andwhich belong to UUAV stock
Yes No [X] Not applicable replacement site Not applicable not UUAV-enrolled site
Review CDC Requirement
In order to ensure that VFC vaccines are only administered to VFC-eligible children VFC providers that serve both VFC and non-VFCshyeligible children must maintain their vaccine inventories in such a way that they can clearly differentiate public stock from privatestock as well as VFC from other public stock
Goal of this question Assess whether the site can distinguish between MnVFC vaccine and private vaccine If they participate in the Uninsured and Underinsured Adult Vaccine (UUAV) program they should also be able to distinguish between MnVFC stock and UUAV stock Some sites use labels bins boxes etc to differentiate their stock If it is not clear how the site differentiates their stock discuss vaccine management with the staff For follow-up call MDH to discuss doing a follow-up site visit
Sites using the replacement method will not have separate stocksmdashthis is an approved alternative method for keeping track of vaccine
Resource bull Section 10 of the MnVFC Policy and Procedure Manual
IPI Advisor Manual | February 2017 Page 49
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
MnVFC Site Visit Storage and Handling Per Unit Answer Sheet 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet MnVFC PIN ___________________
Question number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
Temperature Monitoring Device Questions Questions 43 47 must be answered separately for the freezer and refrigerator if the unit is a combo Be sure to document responses in the appropriate column
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
All the questions on the Site Visit Storage amp Handling Per Unit Answer Sheet have been discussed previously in section 4 of this manual Use this sheet to record information about all the units at the site visit You will need one sheet for each unit If it is a combination unit (either pharmaceutical or household) you can record both sections on one sheet If they have stand-alone units use one sheet for each unit Do not enter the answers to the questions in section 4 of the questionnaire
If you need more information about any of the questions refer back to the main questionnairemdashthe complete question additional guidance including notes to the reviewer and the CDC requirements are there Also if the site is not meeting the requirement you will go back to the questionnaire to complete the ldquoActions if Non-compliantrdquo section including the root cause analysis and follow-up sections
When you have completed the assessment of all the storage units remember to go back to the questionnaire to complete sections 5 and 6
Page 50 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
ndash
ndash
MnVFC Provider Follow-up PlanThe goal of the Provider Follow-up Plan is to communicate with the site all of the VFC requirements any unmet requirements found during your site visit and the timeline for completing the required action The left hand column is a box to check for ldquoUnmetrdquo requirements
Helpful information bull The form can be used to review what the site is doing well and what they need to work on
bull For requirements that have specific documentation that needs to be sent to you use the notes section
2017 MnVFC Provider Follow-up Plan Site _______________________________________________ MnVFC PIN ____________ Date of Visit ___________
Thank you for participating in this MnVFC compliance site visit Please review this visit summary including follow-up actions and timelines for completion Unmet MnVFC requirements and recommendations have a checked box next to them The goal of this plan is to support you with successfully implementing the program and improving access to vaccines for VFC-eligible children
Unmet Question VFC Requirements Section 1 Changes to Key Staff
Q12 Change in the Medical Director Immunization Manager Vaccine Coordinator or back-upKey Staff must be communicated to the immunization program by emailing healthmnvfcstatemnus Changes Notes
Q12 Key staff must complete the annual training on VFC program requirements and print theAnnual Training certificate of completion Documentation Required Action
Staff that have not completed the MnVFC online training must complete it and send acopy of the certificate to the reviewer Training can be found on the MnVFC website (wwwhealthstatemnusvfc) Due date 1 month
Notes
Unmet Question VFC Requirements Section 2 Eligibility
Q21 Provider staff must possess a working knowledge of all VFC eligibility criteria and use thoseVFC Eligibility criteria to screen children prior to administering VFC vaccines
Categories Notes
bull This form provides documentation needed for follow-up actions when you send your thank you email
The second to last page of the Provider Follow-up Plan has a summary of the MnVFC program recommendations These are to remind the site about best practices they may want to improve upon even though they are not yet requirements of the program For example you could discuss the recommendation about storage units if they currently have a combination household unit and are using both sections
The last section is for your signature and the person you met with In most sites it will be the immunization manager or vaccine coordinator who signs the form unless the medical director attended the site visit You keep the original copy and the site will need to keep a copy for themselves
To be completed by the site visit reviewer
I acknowledge that a VFC site visit was performed on __________________ (visit date) The follow-up plan which includes a list of all current VFC program requirements and recommendations assessed during the visit and any required follow-up actions was provided at the end of the visit
Site visit reviewer
Phone
Reviewer Signature Date
To be completed by the provider
I acknowledge that our practice took part in the VFC site visit noted above I understand the findings of the visit and any required actions that must be taken by our office in order to meet VFC program requirements
Medical Director (or designee) Name Title
Medical Director (or designee) Signature Date
IPI Advisor Manual | February 2017 Page 51
The 2017 MnVFC Site Visit Paperwork Chapter 4
After the Site Visit Send a thank you email highlighting the unmet requirements documents you need from the site to resolve the issue(s) and the date you need them Make sure to include the link to the Site Visit Survey (httpssurveyvovicicomseashxs=56206EE334CE0B14)
Please refer to Chapter 3 for more information about future follow-up required after the visit including forms and documentation
Resource bull Sample Thank You letter on IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml)
Chapter 5
IPI Advisor Resource List MnVFC Program 651-201-5522
MnVFC wwwhealthstatemnusvfc
bull Separate Stock and Replacement Method Policies and Procedures Manuals bull Online trainings bull MnVFC Announcements sign up to receive them via email bull Ordering MDH vaccine bull MnVFC forms Screening forms Reporting forms Others MDH Nonviable Vaccine Form MDH Vaccine Transfer Record and Vaccine Borrowing Report
bull MnVFC promotional materials bull Immunization Billing Guidance for MnVFC and Immunization Billing Guidance for MnVFC Replacement Sites Immunization Practices Improvement Program (IPI) wwwhealthstatemnusdivsidepcimmunizeipi
bull IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml) bull IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml) IPI Resource Folder Contents (wwwhealthstatemnusdivsidepcimmunizeipiipifolderpdf)
Minnesota Immunization Information Connection (MIIC) wwwhealthstatemnusmiic
bull MIIC regions and regional coordinators
Clinical Practice MDH Immunization Program wwwhealthstatemnusimmunize
Got Your Shots News wwwhealthstatemnusdivsidepcnewslettersgys
MDH Immunization Information for Health Care Providers wwwhealthstatemnusdivsidepcimmunizehcp
bull Got Your Shots A Providers Guide to Immunization in Minnesota bull Vaccine protocols bull Forms for tracking patient immunizations bull Immunization schedules for Health Care Providers Immunization Action Coalition (IAC) wwwimmunizeorg
bull Ask the Experts bull VISs (Vaccine Information Statements and translations) bull Administration screening questions bull Medical management of vaccine reactions bull Order form for Californiarsquos Immunization Technique DVD Best Practices with Infants Children and Adults
Page 52 IPI Advisor Manual| February 2017
IPI Advisor Resource List Chapter 5
CDC ldquoPink Bookrdquo wwwcdcgovvaccinespubspinkbookindexhtml
CDC Advisory Committee on Immunization Practices (ACIP) wwwcdcgovvaccinesacip
CDC Vaccines and Immunizations wwwcdcgovvaccines
VAERS reporting httpvaershhsgovindex
Storage and Handling Got Your Shots Providers Guide ndash Managing Vaccine wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml
MnVFC Guide to Temperature Monitoring Devices wwwhealthstatemnusvfc
MDH Clinicianrsquos Vaccine Mishap Checklist wwwhealthstatemnusdivsidepcimmunizeipivaxchklstpdf
MDH Vaccine Storage Guide wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml
CDC Vaccine Storage and Handling Toolkit wwwcdcgovvaccinesrecsstoragetoolkit
You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Vaccine manufacturer phone numbers wwwcdcgovvaccinespubspinkbookdownloadsappendicesFcontact-info-manufactpdf
IAC Checklist for Safe Vaccine Handling and Storage wwwimmunizeorgcatgdp3035pdf
IAC Donrsquot Be Guilty of These Errors in Vaccine Storage and Handling wwwimmunizeorgcatgdp3036pdf
Additional Resources Print materials from MDH ndash order forms wwwhealthstatemnusdivsidepcimmunizeordermathtml
Vaccine Education Center ndash Childrenrsquos Hospital of Philadelphia wwwchopeduservicevaccine-education-centerhomehtml
California Department of Public Health ndash Interactive training on vaccine administration and storage and handling handout on transporting vaccine and how to package wwwezizorg
IPI Advisor Manual | February 2017 Page 53
IPI Advisor Resource List Chapter 5
CDC vaccine price list wwwcdcgovvaccinesprogramsvfcawardeesvaccine-managementprice-listindexhtml
Vaccine Information Statements (VIS) wwwcdcgovvaccineshcpvisindexhtml
CEU Opportunities CDC Immunization Education and Training wwwcdcgovvaccinesedindexhtml
Immunization You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Page 54 IPI Advisor Manual| February 2017
- Introduction
-
- Welcome to the Immunization Practice Improvement (IPI) Program
- Contact Information
-
- Chapter 1
- Requirements to Participate in the MnVFC Program
- Vaccines for Children Program
- Chapter 2
- Reimbursement for MnVFC Visits
- Types of Visits
- Your MnVFC Clinical CoordinatorPlanner
- New IPI Advisor Training Requirements
- Your Role as an IPI Advisor
- Reasons MDH Would Do All or Part of a Visit
- Chapter 3
- Future follow-up
- Conducting the Visit
- Preparing for the Visit
- Information for the Visit
- Site Visit Checklist
- Scheduling the Visit
- Chapter 4
- After the Site Visit
- MnVFC Provider Follow-up Plan
- MnVFC Site Visit Storage and Handling Per Unit Answer Sheet
- Section 6 Inventory
- Section 5 Storage amp Handling Site-Wide
- Section 4 Storage amp Handling Per Unit
- Section 3 Documentation
- Section 2 Eligibility
- Section 1 Provider Details
- The Site Visit Reviewer Legend
- MnVFC Site Visit Questionnaire
- Required Paperwork for Site Visits
- Chapter 5
-
Chapter 2 IPI Advisors Your Role as an IPI Advisor As part of an MDH grant agreement with community health boards MDH contracts with local public health agencies to conduct MnVFC site visits in their county
As an IPI advisor you will be responsible for bull Attending the annual training provided by MDH bull Reviewing your county site visit lists and providing any known updates to your MnVFC clinical coordinatorplanner
bull Conducting site visits completing and submitting paper work within 10 days of the visit bull Following up with sites for unmet requirements identified at MnVFC site visits bull Notifying MDH when new sites open that will be storing and administering immunizations (in order to recruit new providers)
bull Keeping up-to-date with new recommendations and requirements for immunizations as well as the MnVFC program Read and be familiar with MnVFC and IPI web pages Sign up to receive email alerts for these resources by clicking on the red envelope at the top of these pages MnVFC Announcements (wwwhealthstatemnusdivsidepcimmunizemnvfcbfaxhtml) Got Your Shots News newsletter (wwwhealthstatemnusdivsidepcnewslettersgysindex html) Immunization Practices Improvement Program (wwwhealthstatemnusdivsidepc immunizeipiindexhtml)
Be designated as the IPI contact in Workspace (httpsoephealthstatemnusworkspace) for your organization Contact your organizationrsquos Workspace administrator to assign you this role
Annual training
Every spring MDH provides training for IPI advisors This training may be in-person or by webinar All IPI advisors are required to attend training each year to review site visit paperwork hear updates on the MnVFC program and ask questions about the process
Clinic lists
Early in the year MDH will send you a clinic list Your list will include all sites in your county that are enrolled in the MnVFC program The priority column indicates whether the IPI advisor MDH staff or the field epidemiologist should complete the visit Those sites not due for a visit that year will have the next year listed Every active MnVFC site is required to receive a site visit at least every other year You can do visits every year if you would like but this is not required Please review the list and notify your MnVFC clinical coordinatorplanner about any changes
IPI Advisor Manual | February 2017 Page 7
IPI Advisors Chapter 2
Included with the list is a one-page information sheet for each site This contains the sitersquos demographic information vaccine coordinator and immunization manager listed in our records whether they are a separate stock or replacement site and the doses and cost of vaccine they received last year Confirm this information with the site and discuss their vaccine quantity and value as part of the questionnaire during your visit
All site visits must be completed by Sept 30 2017 If you think you will be unable to complete all your visits by then you will need to contact your MnVFC clinical coordinatorplanner to determine how the visit will be completed
New IPI Advisor Training Requirements New IPI advisors need to contact MDH before performing any MnVFC site visits on their own A MnVFC clinical coordinatorplanner will help you prepare to perform site visits They will
bull Guide your training See the Training Checklist for IPI Advisors on the IPI Program Resources (wwwhealthstate mnusdivsidepcimmunizeipiresourceshtml) page
bull Have you shadow them or another experienced IPI advisor on one or two site visits bull Shadow you on a visit or two bull Complete the training document
Your MnVFC Clinical CoordinatorPlanner Your MnVFC clinical coordinatorplanner is a MDH staff member that will help support you See who your clinical coordinatorplanner is on IPI Contact Information (wwwhealthstatemnusdivsidepc immunizeipicontacthtml)
The role of the MnVFC clinical coordinatorplanner bull Provide assistance to IPI advisors bull Perform enrollment visits for new sites that will be administering MnVFC vaccine bull Review MnVFC site visit paperwork for accuracy bull Conduct MnVFC site visits where necessary bull Provide additional education or follow-up with sites bull Provide assistance and guidance regarding MnVFC requirements and recommendations to sites bull Provide training to IPI advisors and staff at MnVFC-enrolled sites bull Field storage and handling incident calls
Types of Visits MnVFC Site Visit ndash also known as the Compliance Visit
CDC requires all state immunization programs to conduct site visits to all VFC providers MnVFC site visits are required every other year but sites can be visited on a yearly basis if needed The site visit objectives are to
Page 8 IPI Advisor Manual | February 2017
IPI Advisors Chapter 2
bull Complete the MnVFC site visit paperwork found on IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml)
bull Provide education about MnVFC program requirements and recommendations to site staff bull Ensure MnVFC program requirements are properly implemented and are being met bull Provide feedback and as necessary execute corrective action bull Follow-up on identified issues bull Notify your MnVFC clinical coordinatorplanner of issues that are not resolved by the due date
Follow-Up Visit
In-person follow-up visits will not be necessary for most MnVFC site visitsmdashonly those where significant issues are identified in the original visit If you are not able to complete part of the initial site visit because you found a storage and handling incident or you found multiple issues that need to be addressed a follow-up visit may be necessary Please contact the MnVFC clinical coordinatorplanner for approval and guidance for conducting a follow-up site visit
Educational Visit
Some sites may need more information and education than you can provide during a normal site visit This may be on topics related to immunizations immunization practices or administration or storage and handling issues These visits go beyond the sharing of pamphlets resources or information that is presented at a site visit Education visits should be conducted with a group and should focus on a topic that is identified during a site visit or requested by site staff Regularly scheduled meetings are not considered educational visits Educational visits need to be approved prior to the visit by the MnVFC clinical coordinatorplanner in order for you to receive reimbursement from the MnVFC program
Unscheduled (Unannounced) Storage amp Handling Visit
Unscheduled (unannounced) visits are not pre-scheduled with the site These visits require different paperwork and focus primarily on the storage and handling portion of a MnVFC site visit The MnVFC program is required to visit 5 percent to 10 percent of enrolled sites as unannounced visits each year Please discuss any unscheduled visits you would like to do with the MnVFC clinical coordinatorplanner You should plan to complete all of your regularly scheduled visits before doing any unscheduled visits
Enrollment Visit
All sites (including satellite clinics) that receive stock or supply MnVFC vaccine must have an enrollment visit that is conducted by MDH staff As an IPI advisor you may be asked to attend the enrollment visit This is an opportunity for you to start your relationship with the site and help with follow-up that may be necessary for the site to receive MnVFC vaccine Newly enrolled sites are scheduled for their first regular site visit within the first year (preferably within 3 to 6 months) and then every other year
IPI Advisor Manual | February 2017 Page 9
IPI Advisors Chapter 2
Reimbursement for MnVFC Visits Local public health agencies are paid for the site visits they conduct MDH will reimburse participating agencies only after we receive all of the required paperwork Paperwork submitted with incorrect or missing information may delay the reimbursement
IPI program reimbursement is processed on a quarterly basis and is processed in the month following each quarter through an electronic transfer of money Your agencycounty IPI advisor contact will receive an email notification of the reimbursement
Reimbursement rates are updated annually and available on the Contracts and Reimbursements (www healthstatemnusdivsidepcimmunizeipicontreimhtml) page
2017 MnVFC Site Visit Reimbursement Rates MnVFC Site Visit $400 Follow-up Visit$150 Education Visit$100 Unscheduled Visit$300
Reasons MDH Would Do All or Part of a Visit MDH may complete site visits or accompany you on a site visit if
bull The site is new to the MnVFC program (enrollment visit) bull The site has known issues or concerns regarding the MnVFC program especially if you are having difficulty resolving these issues
bull The site is refusing a site visit from local public health or yoursquore having a difficult time scheduling a visit
bull The site is part of tribal health or Indian Health Services bull MDH district epidemiologists will perform site visits at local health departments bull A new IPI advisor needs training from MDH staff bull Note MDH district epidemiologists will perform site visits at local health departments
Page 10 IPI Advisor Manual | February 2017
Chapter 3 Site Visits Scheduling the Visit
bull Check the information sheet or contact the site to confirm who the contact person is in charge of the MnVFC program In general this is the immunization manager or vaccine coordinator If the contact is no longer there ask for the person in charge of the sitersquos vaccines or the clinic manager They can usually direct you to the appropriate person You may want to follow a suggested phone script when contacting the site
Sample Phone Script for Scheduling a Visit
ldquoHello My name is _______ I am calling from ________ Health Department May I speak to (contact name) [If not available determine appropriate person to talk to or a better time to call back] I am calling to schedule a MnVFC site visit This visit will involve a review of immunization practices at your site We will look at vaccine administration storage and handling screening for eligibility and documentation of vaccinations It usually takes about two hours for a visit depending on the number of vaccine storage units you have Is there a day or time of day that works best for you
I have a pre-visit worksheet to send to you to help you prepare for the visit It contains information about what I will need at the visit such as temperature logs and immunization documentation information Completing this worksheet prior to me arriving will help the visit be more efficient Is there any other information that I can send to help you prepare for the visit
If you have any questions call me at ________ Thank you for your time and assistance I look forward to working with yourdquo
bull Arrange a date and time for the visit bull Let them know an approximate visit length Visits are usually around two hours long depending on the size of the site the number of vaccine storage units they have or if they have new staff
bull Request that key staff be present at the visit This could include the immunization manager vaccine coordinator immunization staff clinic manager nurse manager billing staff andor medical director
bull Inform your site contact that you will be sending them an email confirmation along with the MnVFC
Pre-Visit Worksheet
Site Visit Checklist Use the Site Visit Checklist on IPI Advisor Site Visit Materials (wwwhealthstatemnusdivs idepcimmunizeipisvmaterialshtml) to make sure all necessary steps are covered
MINNESOTA VA C CI N ES FO R CHI LD REN PROGRAM
Site Visit Checklist Date of visit Time
Site Name PIN
Address
Contact Phone
Complete Before the visit Comments
Review the clinic list Identify and prioritize which sites you will visit
Email or call to schedule a date and time for the visit Ask for the immunization manager or vaccine coordinator
Email appointment confirmation attach Pre-visit Worksheet and provide instructions for returning it prior to the visit (sample email on website) Include length of the visit and which staff should be present
Add site visit to Outlook calendar and reserve a car (if needed)
Review temp logs and Pre-visit Worksheet
Send a reminder email 2-3 days ahead of the visit
IPI Advisor Manual | February 2017 Page 11
i i li
Site Visits Chapter 3
Information for the Visit2017 MnVFC Pre-Visit Worksheet Site name MnVFC PIN
Address
Medical director Email
Immunization manager Phone
Vaccine coordinator Phone
Vaccine coordinator back-up Email
IPI Site Vis t Preparat on Check st
The staff listed have completed the MnVFC online training and printed a certification of completion Immunization Manager Vaccine coordinator Vaccine coordinator back-up
Have a copy of the most recent provider agreement
Check if the above listed staff have changed since the provider agreement was completed
Check all of the vaccines administered at your site and list the corresponding publication date for each VIS you give to patients
DTaP _____________ Hepatitis A _____________ Hepatitis B _____________ Hib _____________ HPV _____________
Influenza _____________ MCV4 _____________ MMR _____________ MMR-V _____________ PCV13 _____________
Polio _____________ Rotavirus _____________ Tdap _____________ Varicella _____________
Non-Routine Vaccines Men B__________ PPSV23 _____________ Td _____________
Vaccine administration fee charged for MnVFC eligible children is $
Have a Vaccine Management and Emergency Plan that has been reviewed and dated within the last year
Have the borrowing reports if applicable for the last 12 months available at the visit
Have an anaphylaxis protocol that is clearly posted and reviewed annually
Send an appointment reminder email and the MnVFC Pre-Visit Worksheet to the MnVFC contact A sample letter and the MnVFC Pre-Visit Worksheet can be found on the IPI Advisor Site Visit Materials (wwwhealthstate mnusdivsidepcimmunizeipisvmaterialshtml) page You can request that the MnVFC Pre-Visit Worksheet and temperature logs be sent to you prior to the visit for your review
Contact the site by phone or email one or two working days before the scheduled visit to confirm your appointment This is also a good time to ask for directions and parking information if you are not familiar with the site
Preparing for the Visit Review the site visit paperwork to familiarize yourself with the questions For most of the questions there is a ldquoNote to the reviewerrdquo These notes give helpful tips about the information you are looking for when asking this question It contains the rationale for the question and which resources to provide to the site to support the rationale Some sections also require immediate on-site actionsmdashthings you must do while you are at the site and some require future follow up
bull Print copies the of site visit paperwork bull Site visit forms are available on the IPI Advisor Site Visit Materials (wwwhealthstatemnusdivs idepcimmunizeipisvmaterialshtml) page 2017 MnVFC Site Visit Questionnaire 2017 MnVFC Site Visit Storage amp Handling per Unit Answer Sheet (print one for each stand-alone andor combination storage unit at the site) 2017 MnVFC Provider Follow-up Plan (print two copies)
bull Review any previous site visit paperwork that is available You should check in with MDH staff after your visits if the site continues to have the same issues as past visits
bull Also be sure to bring Your thermometers If the sitersquos certificate of calibration is expired or the probe is not properly placed place your thermometer in the storage unit when you arrive and read the temperature just prior to reviewing the site visit findings
The MnVFC folder with additional immunization resources you wish to add (see chapter 5) and the Vaccine Storage amp Handling magnet (to order email healthIPIinquiriesstatemnus) A copy of the appropriate MnVFC Policies and Procedures Manual found on the MnVFC website (wwwhealthstatemnusvfc) Appropriate temperature logs (Celsius or Fahrenheit) Site information sheet that contains the quantity and value of the vaccine distributed to the sitesystem
Page 12 IPI Advisor Manual | February 2017
Site Visits Chapter 3
Conducting the Visit Education is a large part of the MnVFC site visit Often approaching this visit as an exchange of information with the site is more successful than a ldquoregulatoryrdquo visit Putting the staff at ease answering their questions and making a plan to address issues that arise during the visit is more helpful than a ldquopassfailrdquo attitude Education will usually consist of providing the rationale for the requirement referring to the requirement in the MnVFC Policies and Procedures Manual and providing resources to help address the situation Some questions will require additional follow-up to assure the site has corrected the issue(s) and is meeting the MnVFC requirement(s) This will be addressed further in the follow-up section
Completing the Paperwork
There are three documents that you must complete for the MnVFC site visit bull 2017 MnVFC Site Visit Questionnaire bull 2017 MnVFC Site Visit Storage amp Handling per Unit Answer Sheet (one for each storage unit) bull 2017 MnVFC Provider Follow-up Plan (two copies or you may ask them to make you a copy of the completed form for their records)
Answer the questions on the MnVFC Site Visit Questionnaire based on how things are when you arrive at the site If they correct the issue during the visit you will still mark it as an unmet requirement and document how it was addressed during the visit
The ldquoAnswerrdquo field will contain all the possible answer choices for this question For most questions answer choices will be followed by the markings below
bull Answer choices with no marking mean the site meets the CDC requirement bull Answer choices marked with an [X] indicate that this specific answer choice is non-compliant with a CDC requirement
bull Answer choices marked with an [O] indicate that this specific answer choice is not aligned with a CDC recommendation
If you marked the box with the [X] which is non-compliant with the CDC requirement conduct a root cause analysis to determine the reason for non-compliance Root cause analysis is an important component to a successful site visit It is used to identify the cause of the problem and help to resolve the issue There are several possible root causes that can be identified Choose only one root cause
bull Human cause Personal beliefsopinions Does not understand rationale of requirement Lack of concern for compliance
bull Organizational cause Competing job assignmentsworkload Lack of (insufficient) staff to perform required duties Budget limitations (for required equipment) Lack of (insufficient) training of staff Lack of (insufficient) processesprotocols
IPI Advisor Manual | February 2017 Page 13
Site Visits Chapter 3
Once identified the root cause should be documented in the questionnaire including a brief explanation of why you chose that cause This allows for follow-up with the site and a way to help find improvements to meet the unmet requirement Complete any immediate on-site action These often require providing education and resources for the site Mark the box for each action taken If you provide additional resources or information you can use the notes section to indicate the additional items
ldquoFuture follow-uprdquo are actions the site needs to take to meet the requirements of the program Wersquoll go over more specific information about the site visit questionnaire in Chapter 4
Performing the Site Visit
As you become familiar with the MnVFC program and develop a relationship with your sites you will develop a visit pattern that works for you Here is one possible sequence for conducting MnVFC site visits
bull When you arrive at the site if you have a business card it is helpful to provide it to the front desk staff person
bull When you meet with the immunization manager andor vaccine coordinator introduce yourself and explain the expectations for the visit
bull Ask to see the temperature monitoring device(s) It must have a current certificate of calibration and the probe must be properly placed in the unit If it does not meet the requirements place your thermometer in the unit at the beginning of the visit so that it has sufficient time to reach an accurate temperature by the time you complete your assessment of the storage units
bull 2017 MnVFC Site Visit Questionnaire Ask all of the questions You may have to modify the order of the questions based on what is best for the site When you get to the storage and handling section (section 4) use the answer sheet(s) to document the answers to the questions for each storage unit that stores vaccine (MnVFC or private) Do not write answers in the questionnaire unless there is an unmet requirement Be sure to ask if there is vaccine stored anywhere else at any time at this location This includes a co-located pharmacy If so these additional units will need to be assessed as well If the site has a combination refrigeratorfreezer household unit and is using both sections discuss with them the recommendation (and probable future requirement) to have a separate freezer Refer to MDH if they have further questions or need more information Be prepared to address any storage and handling mishaps that you may find A copy of the
Clinicianrsquos Vaccine Mishap Checklist is with your visit materials and the Emergency Response Worksheet is in the MnVFC Policy and Procedure Manual If you are unsure how to handle the problem call the MnVFC program at 651-201-5522 during or after the visit
Page 14 IPI Advisor Manual | February 2017
Site Visits Chapter 3
Ending the Visit bull Fill out the two copies of the 2017 MnVFC Provider Follow-up Plan (or ask them to make a copy once it is completed for their records) Indicate if they have not met the requirement by checking the box in the ldquoUnmetrdquo column If they are not meeting requirements check the required actions Review the plan with them reinforcing the positive things they are doing as well as reviewing the required follow-up action(s) Give the site a copy of the Provider Follow-up Plan Keep the signed copy of the Provider Follow-up Plan to submit with your paperwork Do not leave a copy of the Site Visit Questionnaire at the site
bull Let them know you will be sending a thank you email that will summarize the site visit Included in the email will be a survey link you would appreciate them completing regarding the visit
After the Visit bull Send the site a thank you email There is a template thank you letter on the IPI Advisor Site Visit Materials (wwwhealthstate mnusdivsidepcimmunizeipisvmaterialshtml) page Be sure you include the issues that you identified and the timeline for their completion as well as the good things you found at the visit In the template letter be sure to include the survey link The survey is very brief ndash a few questions and space to write comments
bull Either transfer your MnVFC Site Visit Questionnaire and MnVFC Site Visit Storage amp Handling per Unit Answer Sheet information to the fillable version or submit the handwritten form to MDH
Documentation of the Visit
Paperwork must be submitted to MDH within 10 days of the visit in order to meet the federal VFC programrsquos reporting requirements Do not wait to complete your follow-up before submitting the site visit paperwork
Send the following documents to MDH bull 2017 MnVFC Site Visit Questionnaire (includes the cover sheet) bull 2017 MnVFC Site Visit Storage amp Handling per Unit Answer Sheet (one for each unit) bull 2017 MnVFC Provider Follow-up Plan (original signed plan)
Submit site visit materials to bull Email healthIPIinquiriesstatemnus (preferred) bull Mail IPI Program Specialist
Immunization Practices Improvement Program Minnesota Department of HealthPO Box 64975St Paul MN 55164-0975
IPI Advisor Manual | February 2017 Page 15
Site Visits Chapter 3
Future follow-up Follow-up is an important component of the site visit It helps us ensure that the unmet requirements have been corrected The questionnaire has different time periods for follow-up depending on the question Do not wait to complete your follow-up before submitting the site visit paperwork
When you complete the Follow-Up Form make sure to keep a copy for yourself MDH also keeps track of follow-up required and will remind you if follow-up has not been completed by the deadline Most follow-up can be done with a phone call or email In-person follow-up is rarely required and should be discussed with MDH before scheduling a follow-up visit
All requirements that need follow-up are identified with a [X] on the site visit paperwork and are listed on the MnVFC Provider Follow-up Plan
bull Follow-up with the site to see how they have resolved the unmet requirements bull Document your follow-up on the Follow-Up Form available on the IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml) page If follow-up was done via letter or email a copy can be attached to the Follow-Up Form
bull Send your Follow-Up Form to MDH (healthIPIinquiriesstatemnus) with supporting documents and emails
bull If a site is not responding to your requests regarding follow-up contact your MnVFC clinical coordinatorplanner They can help with additional follow-up as needed
Page 16 IPI Advisor Manual | February 2017
Chapter 4 The 2017 MnVFC Site Visit Paperwork This chapter will go through the required MnVFC site visit paperwork with notes about information or resources to help the site address questions or issues that may arise during the visit
The MnVFC site visit paperwork is available on the IPI Advisor Site Visit Materials (wwwhealthstate mnusdivsidepcimmunizeipisvmaterialshtml) page
Please download the paperwork shortly before your visit as there may be updates and changes and this will be the most up-to-date version of the questionnaire We will send out a Workspace message with major changes
Required Paperwork for Site Visits bull 2017 MnVFC Site Visit Questionnaire bull 2017 MnVFC Storage amp Handling Per Unit Answer Sheet ndash one for each unit assessed during site
visit bull 2017 MnVFC Provider Follow-up Plan ndash with provider signature
Make sure to include the sitersquos PIN on all your paperwork Please complete and submit your site visit paperwork as soon as possible after your visit It may be helpful to schedule some time into your calendar to complete your paperwork in the days following your visit Once you have completed the post-visit follow-up send in the Follow-Up Form with documentation of the follow-up actions Please do not wait until you have completed your follow-up before sending in your initial paperwork
MnVFC Site Visit Questionnaire The questionnaire includes these six sections 1 Provider details 2 Eligibility 3 Documentation 4 Storage amp handling per unit 5 Storage amp handling site-wide 6 Inventory
IPI Advisor Manual | February 2017 Page 17
Page 18 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
The Site Visit Reviewer Legend The legend explains the formatting of the 2017 questionnaire This includes information that will be helpful in completing the site visit
Site Visit Reviewer Guide Legend
Section Number Content Area
Question number This area will always contain the text of the question
Note to reviewer The note to reviewer contains information that is necessary for properly asking and assessing responses tothe question above This may include definitions of terms requirement details and other helpful tips
Answers This field will contain all the possible answer choices for this question For most questions answer choiceswill be followed by the markings below
Answer choices marked with an [X] indicate that this specific answer choice is non-compliant with a CDC requirement Answer choices marked with an [O] indicate that this specific answer choice is not aligned with a CDC
recommendation
Review CDC RequirementRecommendation
This field will be populated with the CDC requirementrecommendation associated with the given question
Actions if Non-Compliant
Root Cause Analysis As part of the site visit reviewers are required to assess and understand the reasons why a provider office isnon-compliant with VFC program requirements ndash this is a root cause analysis Reviewers must choose theone root cause that they believe most contributes to the non-compliance Upon establishing the root causethe reviewer must provide a clear explanation of hisher findings
Immediate Action These are actions that CDC requires reviewers to take on site during the visit
Future Follow-up These are future follow-up actions (with designated due dates) that are required of the reviewer andorprovider to remedy non-compliance Reviewers must complete all follow-up in accordance with CDCestablished deadlines
Notes Information you want the VFC program to be aware of or that explains your answer in detail
bull Note to reviewer These are notes to help you understand what the question is asking for and to clarify things you might want to know when asking or rephrasing the question
bull Answers This section helps you to know when the answer does not meet the CDC requirement [X] or recommendation [O] Whenever an answer with a [X] is checked the ldquoActions if Non-compliant section must be completed The recommendations are usually good teaching points about best practices andor future requirements of the VFC program
bull Review the CDC RequirementRecommendation This section provides a specific outline of the requirement or recommendation to give you information to use in talking with the site staff
bull Actions if Non-Compliant This section describes what to do if the site is not meeting a requirement Root cause analysis This section asks you to probe beyond the surface to find what is driving the non-compliance It is intended to help uncover reasons for recurring non-compliance issues identify additional training needs and inform reviewer follow-up actions Select only one root cause and explain the particular circumstances in the space ldquoExplanation of root causerdquo line provided If there appear to be multiple issues choose the one that most contributes to the non-compliance and describe all factors in the explanation Immediate actions A list of actions to take during the site visit to address the issue Future follow-up A list of actions to take after the site visit by the set deadline
bull Notes This section can be used for notes to yourself or to MDH
IPI Advisor Manual | February 2017 Page 19
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 1 Provider Details Questionnaire Coversheet
The first page of the questionnaire collects the demographic information for the site You can use this page to help prepare for the visit Most of the demographic information about the site should be on the site-specific document you received with your clinic list You will validate that this information is current at the time of the site visit It also helps to know if this is a separate stock site or a replacement site before the visit so you can bring a copy of the appropriate MnVFC Policies and Procedure Manual
2017 MnVFC Site Visit Questionnaire Date of visit _____________ Date forms sent to MDH ______________
Site Information
Site name MnVFC PIN
Address Separate Stock Replacement
City ZIP County
Medical Director Email
Immunization Manager Phone
Vaccine Coordinator Phone
Vaccine Coordinator back-up Email
Point of contact Phone
Personnel at site visit
On this page bull The date of the visit and the date when you send these forms to MDH This information helps us track the timeliness of our review and data entry process
bull The vaccine management method used by the site (replacement or separate stock) bull The name and email of the medical director (ideally this is the person who signed the MnVFC
Program Provider Agreement)bull Contact information for the immunization manager vaccine coordinator vaccine coordinator back-up and point-of-contact for this visit The immunization manager vaccine coordinator vaccine coordinator back-up roles are
described in the MnVFC Policies and Procedure Manual The vaccine coordinator back-up may be the immunization manager or another staff person depending on the size of the site and available personnel The Point of Contact is the person you set up the appointment with signs the Provider Follow-
up Plan and receives the follow-up email This may be one of the people listed above
The Post Visit Steps section is a reminder to you about what needs to done after the visit The Education on Immunization Best Practices for Sites section reminds you to provide the resource folder to the site
Page 20 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 12
1 Provider Details Changes to Key Staff
Question 12 Ask the provider about changes to key staff to answer the questions below
A (Choose all that
apply)
At the time of the visit is the Medical Director the same individual that signed the ProviderAgreement and are the Immunization Manager and Vaccine Coordinator the same asthose last reported to the program
Yes No the Medical Director has changed No the Immunization Manager has changed No the Vaccine Coordinator has changed
B (Choose one)
Were all changes communicated to theImmunization Program according to yourprogramrsquos policy
Yes or no staff changes No [X]
C (Choose one)
Based on review of the trainingdocumentation have the current Immunization Manager Vaccine Coordinator and back-up completed all required training
Yes No [X]
Review CDC Requirement
All changes in key staff must be communicated to the Immunization Program in the manner and timeframe defined by theImmunization Program Key staff include the Medical Director or equivalent who signed the Provider Agreement the Immunization Manager Vaccine Coordinator and the back-up VFC providers are required to ensure that all key staff are fully trained on VFC program requirements at all times All training must be documented
Goal of this question Determine if there are new staff in key positions at the site and to make sure staff are properly educated about the MnVFC program A This information can help you determine the level of knowledge and experience the staff have with the MnVFC program Follow-up throughout the visit can be tailored for various levels of staff experience Likewise you may identify additional training needs for new staff
B When sites notify us of changes in key personnel we update their information in MIIC and on the clinic lists We also send the new staff information for completing the online training and direct them to read the appropriate MnVFC Policies and Procedures Manual If the answer to this part is no update the demographic area of the questionnaire and inform the staff that in the future they must notify the MnVFC program (via email or phone) if the immunization manager or vaccine coordinator changes Resource Section 12 of the MnVFC Policies and Procedures Manual
C Annual training must be verified by looking at the certificates for the online training If the answer to this part is no refer the staff to complete the appropriate MnVFC online training found on the MnVFC website (wwwhealthstatemnusvfc) for their program (separate stockreplacement) for the current year and send you a copy of the certificate within 30 days
Resource bull Sections 12 and 14 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 21
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 2 Eligibility Question 21
Goal of this Question Assess whether staff correctly understand which patients are eligible for the MnVFC program Screening ensures that eligible children receive the vaccines that they are entitled to receive under the MnVFC program and helps to prevent fraud or abuse of the program
Children 18 years and younger in these
categories can receive MnVFC vaccine at any enrolled site bull Uninsured bull Enrolled in a Minnesota Health Care Program (MHCP) Medical Assistance (MA) or MinnesotaCare bull American Indian or Alaskan Native
The following categories are considered underinsured and are only MnVFC-eligible at local public health (LPH) Federally Qualified Health Centers (FQHC) Rural Health Centers (RHC) Indian Health Services (IHS) and tribal health clinics
bull Has health insurance that does not cover one or more vaccines as can be the case with newly licensed vaccines that arenrsquot yet covered (MnVFC-eligible for non-covered vaccines only)
bull Has health insurance that caps vaccine coverage at a certain amount Once that amount is reached the child is MnVFC-eligible
Children with insurance that does not cover vaccines until a deductible has been met are considered to be fully insured and are not MnVFC-eligible
Helpful information bull Sites are not required to verify the patientrsquos response to the screening questions For example if a patient states they lost their insurance the site does not need to call the patientrsquos insurance company to confirm
If the site cannot correctly describe the eligibility categories provide educational materialsresources on MnVFC eligibility requirements
Resources bull Patient Eligibility Screening Record on MnVFC Forms (wwwhealthstatemnusdivsidepc immunizemnvfcformshtml)
bull Section 1 of the MnVFC Policies and Procedures Manual
2 Eligibility VFC Eligibility Categories
Question 21 Was the individual responsible for determining patient VFC eligibility able to explain all the factors(including age) that make a child eligible to receive VFC vaccines
A Patient is less than 19 years of age Yes No [X]
B Patient is Medicaid-eligible Yes No [X]
C Patient is uninsured Yes No [X]
D Patient is underinsured Yes No [X]
E Patient is American Indian Yes No [X]
F Patient is Alaska Native Yes No [X]
Review CDC Requirement
VFC providers must possess a working knowledge of all VFC eligibility criteria and use those criteria to screen children prior toadministering VFC vaccines In order to receive VFC vaccine a patient must be under the age of 19 and must be at least one of the following (1) Medicaid-eligible (2) Uninsured (ie child has no health insurance) (3) Underinsured (ie child has health insurancebut coverage does not cover any or certain vaccines ndash underinsured children may only receive VFC vaccines in FQHCRHC ordeputized VFC provider offices and only for vaccines not covered by insurance) and (4) American Indian or Alaska Native (AIAN)
Page 22 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 22
2 Eligibility Billing Practices
Question 22 Is the individualdepartment responsible for billing able to clearly explain how they bill for both the costof vaccine and the vaccine administration fee for each of the eligibility categories below
A Medicaid-eligible Cost of Vaccine Do not bill ndash provided by VFC Admin Fee Bill Medicaid
Yes No [X]
B Uninsured Cost of Vaccine Do not bill ndash provided by VFC Admin Fee If billing can bill patient
Yes No [X]
C Underinsured Cost of Vaccine Do not bill ndash provided by VFC through FQHCsRHCs or deputized providers only all other providers cannotprovide VFC vaccine to underinsured patients Admin Fee If billing can bill patient
Yes No [X]
D American IndianAlaska Native(AIAN)
Cost of Vaccine Do not bill - provided by VFC unless patient is fully insured and parent chooses to use insurance Admin Fee If patient is Medicaid-eligible bill Medicaid if billingand patient is uninsuredunderinsured can bill patient if parentchooses to use private insurance for cost of vaccine billpatientinsurance
Yes No [X]
E Do individuals responsible for billing have access to the results of eligibility screening toensure proper billing
Yes No [X]
Review CDC Requirement
VFC providers must adhere to proper billing practices for vaccine administration fees and clearly understand that VFC vaccine isprovided at no cost to both the VFC provider and eligible children At no time should billing occur for the cost of VFC vaccine Whenadministering VFC vaccine providers should never bill two different ldquopayersrdquo (ie patient Medicaid insurance) for the samevaccine administration fee amount For Medicaid-eligible children Medicaid should be billed for the vaccine administration fee Forall other VFC-eligible populations the patient may be billed within the stateterritory cap established by the Centers for Medicareand Medicaid (CMS) However patients cannot be turned away or reported to collections for inability to pay the administration fee
Goal of this question Determine if the staff correctly understand how to bill patients that are eligible for the MnVFC program Billing appropriately ensures that children can receive low cost immunizations and the site is in compliance with the VFC program
bull If there is any indication that sites could be billing insurance companies or parents for VFC vaccines this should be investigated further
bull Most sites in Minnesota will bill Medicaid with the SL modifier ndash which indicates this is a Medicaid claim
bull The main point is to ensure the site is not billing uninsured children for VFC vaccine and are not charging them more than $2122 per vaccine for the administration fee
bull Non-compliance is usually unintentional and may be resolved with some training In rare cases it could be a glimpse into a larger problem where a site is intentionally billing for financial gain
bull If you think the site is billing inappropriately it is the responsibility of the IPI advisor to report concerns to MDH staff for further assistance
Resources bull Immunization Billing Guidance for MnVFC (wwwhealthstatemnusdivsidepcimmunizemnvfc billingtipshtml) or Immunization Billing Guidance for MnVFC Replacement Method Sites (www healthstatemnusdivsidepcimmunizemnvfcreplacementbillingtipsrephtml)
bull Section 2 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 23
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 232 Eligibility Vaccine Administration Fee
Question 23 Document the actual vaccine administration fee charged to non-Medicaid VFC-eligible patients (confirmwith billing department)
Answers Fee $ [X] Follow-up is required if the provider charges more than the fee cap establishedby the Centers for Medicare and Medicaid (CMS) for your stateterritory ($2122)
Review CDC Requirement
The VFC providerrsquos vaccine administration fee for non-Medicaid VFC-eligible children must not exceed the stateterritory vaccineadministration fee cap established by the Centers for Medicare and Medicaid (CMS) For current fee caps refer to Medicaid Program Payments for Services Furnished by Certain Primary Care Physicians and Charges for Vaccine Administration Under theVaccines for Children Program Final Rule (httpwwwgpogovfdsyspkgFR-2012-11-06pdf2012-26507pdf)
Goal of this question Ensure that sites are not charging more than the federal allowable vaccine administration fee of $2122
bull The Centers for Medicaid and Medicare (CMS) establishes a maximum fee that sites can charge to non-Medicaid-eligible VFC patients in each stateterritory for vaccine administration Health Plans usually negotiate this fee with the site but Medicaid will not pay more
bull If a parent cannot pay the vaccine administration fee the patient cannot be turned away or reported to collections VFC-eligible children must be vaccinated regardless of their ability to pay
bull If the person with whom you are conducting the site visit does not know the exact fee charged to non-Medicaid VFC-eligible patients ask to speak to someone who can verify the exact amount
bull If they are charging more than $2122 for the administration fee ndash please contact MDH staff for help with addressing this situation
Resources bull Immunization Billing Guidance for MnVFC (wwwhealthstatemnusdivsidepcimmunizemnvfc billingtipshtml) or Immunization Billing Guidance for MnVFC Replacement Method Sites (www healthstatemnusdivsidepcimmunizemnvfcreplacementbillingtipsrephtml)
bull Section 2 of the MnVFC Policies and Procedures Manual
Page 24 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 3 Documentation Question 31
3 Documentation Eligibility Screening amp Documentation
Question 31 To answer the questions below the provider must clearly demonstrate the patient intake processReview a minimum of 10 records that contain an immunization visit within the last 6 ndash 12 months
Note to Reviewer Criteria for Record Selection 1) Record selection must be completely random and the provider must not know prior to the visit which
records will be reviewed 2) Patient must have been 0-19 years of age at the last visit (Note Records of 19-year-old patients may
allow you to see if VFC vaccines are being used beyond the allowable age) 3) Must review a mix of public and private-pay patients (if applicable)
A Does the provider have a process that ensures that patients are screened forVFC eligibility at each visit and that screening results are documented at each visit
Yes No [X] (If no skip question F)
B Does the providerrsquos process ensure that staff administering vaccine know which vaccine stock to select from prior to drawing the vaccine
Yes No [X]
C Number of records reviewed If fewer than 10 records are reviewed select the reason why Provider does not have 10 patient records with immunizations in last 12 months
D Do all records contain date of the immunization visit and patientrsquos date of birth Yes No [X]
E Do all records contain the patientrsquos specific eligibility status associated with thedate of the immunization
Yes No [X]
F Do any of the providerrsquos records contain any evidence that the patient received vaccine for which they were not eligible
Yes [X] No
Review CDC Requirement
VFC providers must screen for and document VFC eligibility at each immunization visit Documentation must include the date of the visit and the childrsquos specific eligibility category VFC providers must use screening results to ensure that only VFC-eligible children receive VFC vaccine and that administration fees are billed for as appropriate Eligibility status must be readily available to staff administering vaccine prior to selecting which vaccine stock to use
Goal of this question Ensure the site is screening for eligibility and documenting the eligibility category in the medical record
Review a minimum of 10 records from within the last 6-12 months where the patient received an immunization You must review a mix of public and private pay patients (if applicable)
Random selection is important If the staff have pre-selected records for review do not use and identify additional randomly selected records to review
Helpful information bull Discuss upgrading the electronic health record to make documentation of VFC eligibility screening a required field Documenting eligibility screening in the immunization field promotes better MIIC data
bull Q 31 B Sites using the replacement method of vaccine management only have one stock so you will answer ldquoYesrdquo to this question
Resources bull Patient Eligibility Screening Record on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfcformshtml)
bull Section 1 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 25
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 32
3 Documentation Vaccine Dose Documentation
Question 32 Review a minimum of 10 patient immunization records from the last six months (or 12 months ifnecessary) to assess compliance with documentation requirements set forth by Statute 42 US Code 300aa-25 (See note to reviewer below)
Note to Reviewer Criteria for Record Selection 1) Record selection must be completely random the Provider must not know prior to the visit which records
will be reviewed 2) Patient must have been 0-19 years of age at the last visit (Note Records of 19-year-old patients may allow
you to see if VFC vaccines are being used beyond the allowable age)
Records are Compliant if they Contain ALL the Below Elements
bull Address of clinic where vaccine was administered bull Publication date of VIS bull Name of vaccine administered bull Name of vaccine manufacturer bull Date vaccine was administered bull Lot number bull Date VIS was given bull Name and title of person who administered the
vaccine
A Number of records reviewed
B Number of records that contain ALL required documentation elements
If fewer than 10 records are reviewed select the reason why Provider does not have 10 patient records with immunizations in last 12 months
[X] Follow-up isrequired if one ormore records do not meet requirements
Goal of this question Assess whether the site is documenting all required information in each patientrsquos medical record for every vaccine dose administered in accordance with the National Childhood Vaccine Injury Act
Resources bull Section 6 of the MnVFC Policies and Procedures Manual bull National Vaccine Injury Compensation Program (wwwhrsagovvaccinecompensation)
Question 33
3 Documentation Record Retention
Question 33 Is the provider able to demonstrate (preferred) or clearly describe how they maintain historical VFCeligibility documentation for three years
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers are required to maintain all records related to the VFC program for a minimum of three years (or longer if requiredby state law) and upon request make these records available for review VFC records include but are not limited to VFC screening and eligibility documentation billing records medical records that verify receipt of vaccine vaccine ordering records and vaccinepurchase and accountability records
Goal of this question Make sure the site understands they are required to keep all MnVFC screening documentation for at least three years either electronically or on paper This information should be available to you at the time of the visit and future visits
Resource bull Section 7 of the MnVFC Policies and Procedures Manual
Page 26 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 34
3 Documentation Borrowing Documentation
Question 34 Discuss borrowing practices with the provider to answer the questions below
Note to Reviewer bull To be considered ldquofully documentedrdquo documentation for each borrowed dose must include thefollowing information
Vaccine type borrowed Date the dose was administered Stock used (VFC or private) Reason appropriate vaccine stock was not used Patient name and date of birth Date dose was returned to appropriate stock
A Did the provider state that they had borrowed any vaccines (whetherdocumented or not) since the last VFC Compliance Site Visit
Yes No (If no skip to question 36)
B Are there any doses for which there is no documentation (ie provider hasindicated that doses were borrowed but cannot verify how many or why)
All doses are documented Some doses are not documented [X] No doses are documented [X] (if nodoses documented skip toquestion 36)
C Were all borrowed doses fully documented (See Note to Reviewer above) Yes No [X]
D Were all borrowed VFC doses either replaced or an order submitted to replacethe doses Yes No [X]
Review CDC Requirement
VFC providers are expected to maintain an adequate inventory of vaccine for VFC and non-VFC-eligible patients It is theresponsibility of the VFC provider to appropriately schedule and place vaccine orders VFC providers must also rotate stock to ensure timely use of short-dated vaccines Borrowing of vaccine between private and public inventories must be a rare unplanned occurrence and cannot serve as a replacement system for a VFC providerrsquos privately purchased vaccine inventory All instances ofborrowing must be properly documented reported and replaced
Goal of this question Assess vaccine accountability by verifying that children are receiving vaccine from the appropriate stock
Borrowing is when a fully insured child receives a dose of MnVFC vaccine or a MnVFC-eligible child receives a dose of private vaccine This should be a rare unplanned occurrence The site must document any borrowing of vaccine between stocks ideally on the VFC Borrowing Report Form If they are not currently using the form review it with them and encourage them to post it close to their vaccines It does not need to be sent to MDH but should be kept for 3 years and filed with their MnVFC documents to be reviewed whenever they have a regular or unscheduled (unannounced) site visit
Helpful information bull Understand and report on staffrsquos verbal (ie anecdotal) accounts of borrowing obtained during the visit Often sites do not know that what they do is considered borrowing or they think borrowing is acceptable and documentation isnrsquot needed so long as those vaccines are eventually replaced
bull Since sites using the replacement method only have one stock of vaccine they very rarely borrow bull This question asks for future follow-up in 6 months Make a note on your calendar and ask them to send you a copy of their borrowing reports for the previous 6 months with documentation of doses borrowed and replaced We will remind you if we donrsquot hear from you at the 6 month time frame Complete the Follow-up Form and attach the borrowing form
Resources bull Vaccine Borrowing Report on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfc formshtml)
bull Section 10 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 27
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 353 Documentation Borrowing Reasons
Question 35 Based on your discussion with the provider and a review of borrowing reports document the dosesborrowed for each reason and answer the questions below
Note to Reviewer bull Short-dated vaccines are doses that are likely to expire before they can be used bull Exchanging short-dated vaccines should only occur in practices that have a small number of private
patients
A Reasons for Borrowing a VFC Dose (Enter the number of _____ Private vaccine shipment delay (order placed on time but delay in shippingreceipt)
vaccine doses borrowed for each
reason in the spaces
_____ Private vaccine not useable on arrival (vials broken temperature monitor out of range) _____ Ran out of private vaccine between orders (provider orders not placed on time) [X]
provided) _____ Short-dated private dose was exchanged with VFC stock _____ Accidental use of VFC dose for a private patient (human error) _____ Replacement of private dose with VFC when insurance plan did not cover vaccine _____ OtherDocumented dose did not include reason for borrowing [X]
(Explanation Required) Reasons for Borrowing a Private Dose _____ VFC vaccine shipment delay (order placed on time but delay in shippingreceipt) _____ VFC vaccine not useable on arrival (vials broken temperature monitor out of range) _____ Ran out of VFC stock between orders (provider orders not placed on time) [X] _____ Short-dated VFC vaccine dose was exchanged with private dose _____ Accidental use of a private dose for a VFC-eligible patient (human error) _____ OtherDocumented dose did not include reason for borrowing [X]
(Explanation Required)
B Enter date range for instances of borrowing reviewed in the borrowing report Note If ldquoDate of earliest instancerdquo is not available use the date of the last VFC Compliance Visit If ldquoDate of last instancerdquo is not available use the date of thecurrent VFC Compliance Visit
Date of earliest instance
Date of last instance
C Does borrowing appear to be a routine practice Note To determine whether borrowing is a routine practice assess frequency of and repeating reasons for borrowing Examples Frequent accidental use of incorrect stock exchanging short-dated vaccines or issues with ordering and shipment
Yes [X] No
Goal of this question Determine the reasons why the site is borrowing vaccine
If sites are using the Vaccine Borrowing Report review the reasons for borrowing to help document borrowed VFC andor private doses If they have not been documenting borrowing on this report (or any other form) estimate their borrowing practices If you do not know the date range for their borrowing use the last site visit date to the current visit date The use of ldquootherrdquo as the reported reason for borrowing should be rare if ever and would require explanation and follow up
Helpful information bull Look to see if they routinely maintain insufficient amounts or types of vaccine to support their public and private patients that leads to borrowing
bull Pay attention to borrowing cases documented as ldquoaccidentalrdquo Repetitive accidental borrowing may indicate an issue with ordering processes or insufficient staff training
bull Borrowing is not a place to document wasted or lost doses bull The time period of the borrowing may give you clues about the root cause Were the borrowed doses concentrated in a short period or spread out across several months or a year Are all vaccine types being borrowed or just one
bull If borrowing seems to be an issue discuss vaccine management ordering procedures
Resources bull Vaccine Borrowing Report on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfc formshtml)
bull Section 10 in the MnVFC Policies and Procedures Manual
Page 28 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 36
3 Documentation Vaccine Management Plan
Question 36 Physically review the providerrsquos Vaccine Management Plan to answer the question below
A Does the provider have a Vaccine Management Plan Yes No [X] (If no skip to question 37)
B Does the plan list the current Immunization Manager Vaccine Coordinator andback-up
Yes No [X]
C Does the plan address proper vaccine storage and handling practices Yes No [X]
D Does the plan specify vaccine receiving procedures Yes No [X]
E Does the plan contain procedures for what to do with vaccine in the event of an emergency
Yes No [X]
F Does the plan contain procedures for vaccine ordering Yes No [X]
G Does the plan address inventory control (example stock rotation) Yes No [X]
H Does the plan address how to handle vaccine wastage Yes No [X]
I Does the plan address staff training and documentation on vaccine managementstorage amp handling
Yes No [X]
J Does the plan contain a review date that falls within the last 12 months Yes No [X]
K Has the plan been signed by the individual responsible for its content Yes No [X]
Review CDC Requirement
VFC providers must develop maintain and implement a Vaccine Management Plan for routine and emergency vaccinemanagement The plan must contain the current Vaccine Coordinator and back-up proper storage and handling practicesshipping and receiving procedures emergency procedures procedures for vaccine ordering inventory control (eg stock rotation)how to handle vaccine wastage and staff trainingdocumentation on vaccine management storage and handling The plan must bereviewedupdated annually or more frequently if changes occur A ldquoreview daterdquo and signature are required on all plans in order tovalidate that they are current
Goal of this question Evaluate the sitersquos plan for vaccine management It is especially important that they have a plan for emergency management of their vaccine in the case of equipment failure or power outage Encourage all sites to read and sign the MnVFC Policies and Procedures Manual and complete the emergency plan or be able to show you a plan of their own
If the provider is not able to physically show you the plan at the time of the visit or if the recorded review date is not within the last 12 months you must mark that this requirement is unmet The Vaccine Management Plan is important in times of emergency and it should be easy to access by any staff member at any time Encourage them to post the plan and put a copy with the packing supplies
Helpful information bull Encourage the site to fill in the ldquoImmunization Managerrdquo and ldquoVaccine Coordinatorrdquo fields in the
MnVFC Policies and Procedures Manual for their own referencebull The emergency plan in the manual can be reviewed from last year and included in this yearrsquos manual (with an updated signature and date) if there have not been any changes
bull If information in the plan is outdated site staff will not be well equipped to safely manage vaccines in the event of a power-outage or other emergency situation
bull If their institutional policy is only reviewed and updated every 3-4 years (as many are) the staff may need to sign the MnVFC Polices and Procedure Manual to meet this requirement
Resource Routine Vaccine Management Plan and Emergency Vaccine Management Plan in the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 29
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 37
3 Documentation VIS amp VAERS
Question 37 Review the providerrsquos Vaccine Information Statements (VISs) and discuss providerrsquos VAERS process toanswer the questions below
A Does the provider have readily available up-to-date VISs for all ACIP-recommendedvaccines relevant to the populations it serves
Yes No [X]
B Does the provider make a VIS available for patientsparents before eachvaccination
Yes No [X]
C Does the provider know how and when to report clinically significant adverseevents using VAERS
Yes No [X]
Review CDC Requirement
VFC providers are required to distribute the current Vaccine Information Statements (VIS) each time a vaccine is administered and maintain records in accordance with the National Childhood Vaccine Injury Act (NCVIA) which includes reporting clinicallysignificant adverse events to the Vaccine Adverse Event Reporting System (VAERS) For a list of current VISs visit CDCrsquos Vaccine Information Statements (httpwwwcdcgovvaccineshcpvis) website
Gal of this question Ensure the site has the most current VISs and is giving them to each patientparent before administering the vaccine in compliance with the federal law Parents must be educated about the vaccine their child will receive and be aware of possible contraindications and side-effects in order to make well-informed decisions about their childrsquos health
Helpful information bull Ask to see the sitersquos VISs to determine if they have an active protocol for giving VISs to parents Review to make sure they are current Ask if they know where and how to report vaccine adverse events
Resources bull Section 3 in the MnVFC Policies and Procedures Manual bull CDC Vaccine Information Statements (wwwcdcgovvaccineshcpvisindexhtml) Site may sign up for email updates for the current list of VIS publication dates for the most up-to-date version
bull IAC Itrsquos Federal Law You must give your patients current Vaccine Information Statements (wwwimmunizeorgcatgdp2027pdf)
bull VAERS (httpsvaershhsgovindex)
Question 38
3 Documentation Anaphylaxis protocol
Question 38 Does the site have an anaphylaxis protocol which is clearly posted near the emergency kit
Answers (Choose one)
Yes No [X]
Review CDC Requirement
An anaphylaxis protocol must be clearly posted in the area where vaccines are administered
Goal of this question Make sure site is prepared for a severe allergic or anaphylactic reaction to a vaccine
Resources bull Section 11 in the MnVFC Policies and Procedures Manual bull IAC protocols Child and Teens (wwwimmunizeorgcatgdp3082apdf) and Adults (wwwimmunize orgcatgdp3082pdf)
Page 30 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
i
i i i - li i i i i i l
Section 4 Storage amp Handling Per Unit The goal of this section is to assess vaccine storage
2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet practices in each unit at the site MnVFC PIN ___________________
The 2017 MnVFC Storage amp Handling Per Unit Answer Sheet is a worksheet to document the answers to the questions in this section for each unit (combination or stand-alone) Fill in the answers to the questions in Section 4 on the answer sheet not in the questionnaire
The answer sheet has an abbreviated form of each question If you need further information on that question refer back to the full questionnaire Also if you find an area where the site is not meeting the requirements you will need to go back to that question on the 2017 MnVFC Site Visit Questionnaire to complete ldquoActions if Non- compliantrdquo section including the root cause analysis and follow-up sections If there is a problem in more than one unit make a note on the questionnaire which unit you are referring to in the Notes section
Important You must fully assess any unit that may be used to store VFC vaccines even if there are no VFC vaccines there on the day of the visit If there are no vaccines and the site is not documenting twice a day temperatures discuss the need to ensure the unit is maintaining stable temperatures by monitoring for one week before placing vaccines in the unit
Quest on number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
for the freezer and e co umn
Temperature Monitoring Dev refr gerator f the un
ce Quest ons Quest ons 4 3 4 7 must be answered separate y t s a combo Be sure to document responses n the appropr at
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
44D Data downloaded and reviewed routinely (eg weekly)
Yes No [O]
Yes No [O]
45A Certificate of Calibration Testing Yes No [X]
Yes No [X]
45B Date of calibration
45C Date certificate expires [X] Follow-up is required if expired [X] Follow-up is required if expired
45D Certificate contains all necessary items
Yes No [X]
Yes No [X]
46 Probe properly placed Yes No [X]
Yes No [X]
47A Two temperature readings per day
Yes No [X]
Yes No [X]
47B Time date and name (or initials) for each reading
Yes No [X]
Yes No [X]
47C Current temperature and minmax temperatures (if
Current ________deg Minimum ________deg Maximum _deg
Current ________deg Minimum ________deg Maximum _deg
Sections 5 and 6 contain questions about storage and handling site wide and inventory It is helpful to keep those questions in mind as you assess the individual storage units Think about dorm-style units expired vaccine vaccine supply room for vaccine stocking all the recommended vaccines and separation of stock if appropriate
NOTE The sections that follow require reviewers to validate responses by looking at vaccine storage units temperaturemonitoring equipment and the vaccine inventory inside a unit bull For section 4 use a separate Storage amp Handling Per Unit Answer Sheet for each unit to document the findings (combination
units using both sections can be documented on the same answer sheet) bull When an unmet requirement is identified return to this questionnaire to complete the ldquoActions if Non-compliantrdquo section for
that question bull After you complete one answer sheet for each unit return to the questionnaire to complete sections 5 and 6 using information
you gathered while assessing the units The questions in sections 5 and 6 (Storage amp Handling Site-Wide and Inventory) are notunit-specific but do require that the response be based on a thorough assessment of all the providersrsquo units
4 Storage amp Handling Per Unit
Description On the Storage amp Handling Per Unit Answer Sheet place a name that will allow you or someone else from your program to easily identify this unit in the event of follow-up We recommend using Brand + Location(example Samsung - Room 123) Save each Storage amp Handling Per Unit Answer Sheet with the Brand + Location in the file name
(example SamsungRoom123doc)
IPI Advisor Manual | February 2017 Page 31
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 41
4 Storage amp Handling Per Unit Storage Unit Build amp Use
Question 41 Below select the build and use of the vaccine storage unit you are assessing
Note to Reviewer Dorm-style units Do not add dorm-style units here Dorm-style units will be addressed in section 5 Units storing only private stock You must review these storage units even if they contain only private stockat the time of the visit because that vaccine could be administered to VFC patients
A What type of unit is this A Stand-alone B Combination
B Select use if stand-alone A Freezer B Refrigerator
Select use if combination A Use both sections to store vaccine B Use freezer section only to store vaccine C Use refrigerator section only to store vaccine
Goal of this question Identify the unit you are evaluating The description asks you to create a unique name for this unit so that you will be able to identify the same unit in future site visits Put this description on the top of the answer sheet (ie make and location)
Helpful information bull A stand-alone unit is either a refrigerator or a freezer It does not have both sections in the unit bull If there is a combination unit note if the site uses both the refrigerator and freezer or only one section of the unit to store vaccines CDC does not recommend the use of either section or the freezer section only of combination household units
bull If your site utilizes the separate stock method of vaccine management you must review storage units even if they contain only private stock at the time of the visit because there is a chance that those vaccines could be administered (borrowed) to VFC-eligible patients
Page 32 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 424 Storage amp Handling Per Unit CDC Recommended Storage Units
Question 42 Below document the grade of the vaccine storage unit you are assessing
Note to Reviewer Pharmaceutical Also called ldquopurpose-builtrdquo these units are designed by the manufacturer specifically tostore vaccines or other biological materials Commercial Although usually intended to store food and beverages commercial units are often larger and more powerful than the household units found in most homes Though these units are intended to meet thehigher demands of larger facilities these units are not specifically built for the storage of biologicalmaterials Household (non-commercialdomestic) These units are usually smaller than commercial units and areintended for use in small offices and in homes ndash typically for food storage However just like commercialunits they are not designed specifically for the storage of biological materials Such units are usually available in common home supply stores
Answers (Choose one)
Select grade A Pharmaceutical B CommercialHousehold
[O] CDC does not recommend the use of both sections or the freezer section only of combination commercialhousehold units
Review CDC Recommendation
CDC recommends the following vaccine storage unit types (in order of preference) pharmaceutical grade stand-alone orcombination units (preferred) householdcommercial stand-alone units householdcommercial combination units using therefrigerator section only
Goal of this question Assess the grade and type of each storage unit bull Pharmaceutical grade units may be stand-alone or combination units that are often metal may have glass in the door for viewing inside often have an external digital temperature display and are manufactured by medical companies
bull Commercial or household units often look like your kitchen appliance have vegetablemeat drawers in the unit and are manufactured by household appliance companies
bull Occasionally you might find a medical grade unit which is usually a commercialhousehold unit with a lock and 3-prong plug These are still considered household units because of their ability to maintain proper temperatures and air flow Studies show that household stand-alone units are better able to maintain consistent temperatures than their combination counterparts Combination household units used to store vaccine in both sections of the unit is no longer recommended and may be prohibited in the future Combination household storage units that are having difficulty maintaining a cold enough freezer temperature and a warm enough refrigerator temperature should be replaced or a separate stand-alone freezer should be purchased
For frozen vaccines the most cost effective solution is for the site to purchase a small stand-alone freezer The site may need time to budget for a stand-alone storage unit
Resources bull Replacing Combination Household Units Tip Sheet on IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml)
IPI Advisor Manual | February 2017 Page 33
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 434 Storage amp Handling Per Unit Temperature Monitoring Device in the Unit
Question 43 Determine whether there is a temperature monitoring device in this section of the storage unit andanswer the questions
A Is there a temperature monitoring device in this section of thestorage unit
Yes No [X] (If no skip to question 47)
B Who is responsible for supplying the temperature monitoring device in this section of the storage unit Provider
Review CDC Requirement
Certificates of calibration testing provide confidence that the temperature monitoring device is measuring temperaturesaccurately All units storing VFC vaccines must have a calibrated temperature monitoring device with a current and valid certificateof calibration testing All certificates must contain modeldevice name or number serial number date of calibration testing (report or issue date) and Instrument Passed testingInstrument in Tolerance (Recommended uncertainty = +-05ordm C (+-1ordm F))
Goal of this question Assess whether there is a temperature monitoring device in the unit If the unit is not being monitored at all call MDH at 651-201-5522 for guidance
Helpful information bull This question does not ask whether the temperature monitoring device is working or the characteristics of the device These issues will be addressed later in the questionnaire
bull For part B the provider is always responsible for supplying the temperature monitoring device Even if their thermometer or data logger was originally from MDH it is their responsibility to ensure it is functional and calibrated
Resources bull Section 8 in the MnVFC Policies and Procedures Manual
Page 34 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 444 Storage amp Handling Per Unit CDC Recommended Temperature Monitoring Device
Question 44 Assess the temperature monitoring device in this section of the storage unit to answer the questionsbelow
A Is the temperature monitoring device a continuous monitoring and recordingdevice (eg data logger)
Yes No [O] (Skip D)
B Does the temperature monitoring device have a probe in buffered material Yes No [O]
C Does the temperature monitoring device have a digital display that can beeasily read from the outside of this unit
Yes No [O]
D Is data downloaded and reviewed routinely Yes No [O]
Review CDC Recommendation
As of Jan 1 2018 all VFC providers must use continuous temperature monitoring devices (eg data loggers) to monitor vaccinesthat will be administered to VFC-eligible children Routine review and accessibility of temperature data is critical for determining whether vaccine has been properly stored and for assessing usability of vaccine that was involved in a temperature excursion Tomeet VFC Program requirements the device must also be equipped with bull A temperature probe bull An active temperature display that can be easily read from the outside of the unit bull The capacity for continuous monitoring and recording capabilities where the data can be routinely downloaded
The following are additional recommended features for these devices bull Alarm for out-of-range temperatures bull Current minimum and maximum temperatures display bull Low battery indicator bull Accuracy of +- 1degF (05degC) bull Memory storage of at least 4000 readings bull User programmable logging interval (or reading rate) recommended at a maximum time interval of every 30 minutes bull Use of a probe that best reflects the temperature of the vaccine (such as a buffered probe)
Goal of this question Assess the temperature monitoring device in the storage unit Note that these are all recommendations not requirements at this time
This is a great teaching opportunity for sites who do not currently have a continuous temperature monitoring device Beginning Jan 1 2018 all units that store MnVFC vaccine will be required to have a continuous temperature monitoring device (ie a data logger or a continuous temperature monitoring system) Unlike a minmax thermometer a continuous temperature monitoring device provides detailed information on all temperatures recorded at pre-set intervals For excursions it can provide information on when a temperature went out-of-range for how long and what the temperatures were This is essential information that vaccine manufacturers need to know to assess the viability of the vaccine following an excursion
Helpful information bull Sites are required to monitor and record temperatures twice daily however temperature excursions can easily occur in the 12 hours or longer between readings Continuous temperature monitoring can help manufacturers determine vaccine viability
bull Continue to encourage sites to document and evaluate minimum and maximum temperatures the storage unit reached since the last reading and respond appropriately to out-of-range temperatures
IPI Advisor Manual | February 2017 Page 35
The 2017 MnVFC Site Visit Paperwork Chapter 4
bull It is recommended that sites download and review data weekly Discuss with sites that reviewing temperature monitoring device data also includes responding appropriately if they identify out-of-range temps
bull There is sometimes confusion about the difference between a data logger and a continuous temperature monitoring system Here are some differences
Data Loggers Continuous Monitoring Systems Have an external display similar to thermometers May or may not have an external display Have a detachable probe Probe is usually attached to transmitter Need to be plugged into the computer or cradle to download information on a regular schedule
Wirelessly sends data to computer system
Create a file of data that needs to be saved on the computer
Data is stored within the system not a separate file
Doesnrsquot allow documentation of twice a day temperature checks in the file
May allow documentation of twice a day temperature checks within the system
More about the 2018 requirement for a continuous temperature monitoring device
Required Features bull The continuous temperature monitoring device must have Continuous monitoring and recording capabilities to track and record temperatures over time The capacity to routinely download temperature data to a computer (recommended at least weekly) or wirelessly transmit data Detachable probe in a bottle filled with a thermal buffer (eg bio-safe glycol) if the data logger needs to be detached in order to download data Active temperature display
Recommended Features bull MnVFC recommends continuous temperature monitoring devices with Alarm for out-of-range temperatures Accuracy within +-1degF (+- 05degC) Low battery indicator Display of current minimum and maximum temperatures Memory storage of at least 4000 readings User programmable logging intervals (eg the user can set how often the device records the temperature)
Note that these are all currently recommendations not requirements yet
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Page 36 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 45
Goal of this question Ensure the temperature monitoring device is properly calibrated The certificate of calibration testing means that the device has been tested and it is accurately measuring temperatures within established testing limits The certificate of calibration ensures that the device meets all the required components
Helpful information bull The provider is always responsible for having a current certificate of calibration (or copy) on-site
bull To be considered ldquovalidrdquo a certificate of calibration must contain these required elements Modeldevice name or number Serial number
4 Storage amp Handling Per Unit Certificate of Calibration Testing
Review CDC Requirement
Certificates of calibration testing provide confidence that the temperature monitoring device is measuring temperaturesaccurately All units storing VFC vaccines must have a calibrated temperature monitoring device with a current and valid certificateof calibration testing All certificates must contain modeldevice name or number serial number date of calibration testing (report or issue date) and Instrument Passed testingInstrument in Tolerance (Recommended uncertainty = +-05ordm C (+-1ordm F))
Question 45
Note to Reviewer
A
B
C
D
E
Review the certificate of calibration testing for the temperature monitoring device in this section of the storage unit and answer the questions below
bull How to determine certificate of calibration testing expiration date 1) Identify the certificate issuecalibration date 2) Apply the Immunization Program-required frequency for calibration testing Example If the
issuecalibration date is 12312013 and Immunization Program policy requires testing every twoyears the expiration date is 12312015
bull Certificates must include all of the below bull ModelDevice Name or Number bull Serial Number bull Date of Calibration Testing (Report or Issue Date) bull Instrument Passed testing (Instrument in Tolerance)
Is there a certificate of calibration testing for the temperature monitoring Yes device in this section of the storage unit No [X]
What is the date of calibration for the temperature monitoring device in this section of the storage unit
What is the certificatersquos date of expiration based on ImmunizationProgram policy (See note to reviewer to determine expiration date) [X] Follow-up is required if
certificate is expired
Does the certificate contain all the necessary items listed in the Note to Yes Reviewer No [X]
Who is responsible for supplying the current and valid certificate of Provider calibration for this temperature monitoring device
Date of calibration testing (report or issue date) Note If there is no expiration date the certificate expires 2 years from the date of calibration Whether the instrument passed or failed testing (or instrument in tolerancenot in tolerance)
bull Recommended element Documented uncertainty of +- 1degF [05degC]
If these elements are present the certificate is considered valid If the certificate contains information about the recommended element or the entity that issued the certificate that is helpful but not required
To determine if a certificate of calibration testing was issued by an appropriate entity check to see if the certificate indicates one or more of these items (this is the wording used to help sites evaluate if their calibration is accurate but is not required on the certificate itself to be considered valid)
bull Conforms to ISO 17025 bull Performed by an ILACMRA Signatory body accredited laboratory You can review this list of the ILAC MRA and Signatories (httpilacorgilac-mra-and-signatories)
bull Traceable to the standards maintained by NIST bull Meets specifications and testing requirements for the American Society for Testing and Materials (ASTM) Standard E2877 tolerance Class F (le 05 degC) or better
bull Includes reference to another acceptable accuracy validation method such as comparison to other traceable reference standards or tests at thermometric fixed points
Note CDC recommends that certifications be issued for the entire monitoring unit (detachable probe data logger etc) and not individual certificates for each component
IPI Advisor Manual | February 2017 Page 37
The 2017 MnVFC Site Visit Paperwork Chapter 4
For 45 E the provider is always responsible for supplying the current and valid certificate of calibration for a temperature monitoring device
bull Tip If the temperature monitoring device has a sticker on the back with the calibration date the site can usually call the company who calibrated the device and get a copy of the certificate if they donrsquot have one
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 46 4 Storage amp Handling Per Unit Probe Placement
Question 46 Is the probe properly placed in this section of the storage unit
Note to Reviewer ldquoProperlyrdquo means that the probe in a commercial or household unit is placed in a central area of the unitdirectly with the vaccines Probes should not be placed in the doors near or against the walls close to vents or on the floor of the unit The only allowable exemption related to this requirement is for providerswho have pharmaceutical storage units (built for vaccine storage) that have either (1) a built-intemperature monitoring device OR (2) a dedicated port for the probe that dictates the placement of theprobe
Answers (Choose one)
Yes No [X]
Review CDC Requirement
The probe must be placed in a central area of the section of the storage unit directly with the vaccines in order to properly measurevaccine temperature The probe should not be placed in the door near or against the walls close to vents or on the floor of theunit For pharmaceutical units with a built-in temperature monitoring device or a dedicated port for a probe that is not in thecenter of the section of the storage unit consult your Immunization Program for guidance on placement
Goal of this question Make sure the temperature monitoring device is in the best location to accurately measure the temperature of the vaccines stored in the unit
Helpful information bull The probe of the temperature monitoring device should be placed directly with the vaccines in the middle of the unit The ONLY allowable exception is for pharmaceutical storage units that have either a built-in thermometer or a dedicated port for the probe that indicates placement of the probe
bull Temperatures can vary within the unit especially household units bull Call MDH at 651-201-5522 if you have questions
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Guide (wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml)
Page 38 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 474 Storage amp Handling Per Unit Temperature Documentation
Question 47 Review the temperature documentation over the past three months for this section of the storage unit todetermine whether the provider has a process in place for properly documenting temperatures twice aday Answer the questions below
A Are there two temperature readings recorded for this section of the storage unit per day
Yes No [X]
B Is there a time date and name (or initials) recorded for each reading Yes No [X]
C What is the current temperature and minmax temperatures (if available) inthis section of the storage unit Use the reviewerrsquos thermometer if the providerrsquos temperature monitoringdevice does not have a current valid certificate of calibration testing or the probe is not properly placed in this section of the storage unit
Current Temperature Minimum Temperature Maximum Temperature Fahrenheit Celsius
D Based on your review of the providerrsquos recent temperature documentationincluding the current temperature is this section of the storage unitmaintaining appropriate temperatures
Yes No [X] Not enough information [X]
Review CDC Requirement
Vaccines must be stored under appropriate temperatures as described in the package inserts at all times Acceptable temperature ranges vary by vaccine type and the range is 36deg F and 46deg F (2deg C and 8deg C) and for frozen vaccines the range is -58deg F and +5deg F (shy50deg C and -15deg C) Exposure to temperatures outside of those included in the package inserts could affect vaccine viability andultimately could leave children unprotected against vaccine-preventable diseases In order to maintain awareness of storage unittemperatures and ensure that vaccines are being stored at appropriate temperatures at all times VFC providers are required to monitor and document temperatures for all vaccine storage units at least twice a day Temperature documentation must contain (1) at least two temperature readings per day (2) the time and date of each reading and (3) the name (or initials) of the personwho assessed and recorded the readings CDC also recommends that VFC providers record the minimum and maximumtemperatures of each unit once each workday (preferably in the morning)
Goal of this question Ensure the temperature is being monitored twice daily is within the required range and documented correctly Use your thermometer to check the temperature if the sitersquos temperature monitoring devicersquos probe is not properly placed or there is not a current certificate of calibration Place your thermometer in the unit at the beginning of the visit to allow sufficient time to reach an accurate temperature The purpose of using your thermometer is to ensure the vaccine is being stored at the proper temperature not to ldquovalidaterdquo their reading
Question 47 D is an assessment question based on information you have learned during your visit You might answer ldquonot enough informationrdquo if the unit is new and they donrsquot have at least three months of data or if the unit is only used as overflow and they are inconsistent with temperature monitoring Mark ldquoNordquo if you have reason to believe the storage unit is not maintaining temperatures properly
Helpful information bull All sites must document temperatures twice a day every day the site is open even if they have a data logger or continuous monitoring system
bull Sites can document the information electronically with some continuous monitoring systems as long as it can show what the current temp is the date time and initials of the person checking ndash this needs to be someone at the site ndash not checking remotely or centrally for a large site or system The site must be able to produce these records during their site visit Reviewing these files can be a challenge due to large volumes and lots of paper
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Temperature Logs on Managing Vaccine (wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml)
IPI Advisor Manual | February 2017 Page 39
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 484 Storage amp Handling Per Unit Temperature Excursions
Question 48 In the event that a temperature excursion(s) occurred in this unit within the last three months requestand review documentation of actions taken to determine whether the provider has a process for properlyaddressing excursions Answer the questions below
A Were vaccines in this unit exposed to out-of-range temperatures in the lastthree months (including today)
Yes No (If no skip to question 49)
B Did the provider quarantine and label vaccines as ldquoDo not userdquo Yes No [X]
C Did the provider place vaccine in a unit where it can be stored under properconditions if applicable
Yes No [X]
D Did the provider contact the Immunization Program to report theexcursion
Yes No [X]
E Was the manufacturer contacted for documentation supporting theusability of the vaccine
Yes No [X]
Review CDC Requirement
The provider must document all excursions and actions taken including the following (1) Quarantine and label vaccines as ldquoDO NOTUSErdquo (2) Place vaccines in a unit where they can be stored under proper conditions (3) Contact the Immunization Program to report an excursion and (4) Contact the vaccine manufacturer to obtain documentation supporting the usability of the vaccine
Goal of this question Address any out-of-range temperatures (temperature excursions) identified in reviewing the last three months of temperature logs or during the site visit If there were any out-of-range temperatures did the site respond appropriately to the situation This is a great opportunity to discuss what to do in the event of an excursion The Clinicians Storage and Handling Mishap Checklist is in the IPI Site Visit information folder and is a good review of the process
Helpful information bull Sites need to know that an excursion does not automatically mean that exposed vaccines are non-viable or unusable Exposed vaccines must be quarantined (marked ldquoDo Not Userdquo) and stored under proper conditions until they have received information from vaccine manufacturers regarding the viability of the vaccine
bull Sites must inform MDH when an excursion occurs
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Clinicians Storage and Handling Mishap Checklist (wwwhealthstatemnusdivsidepcimmunize ipivaxchklstpdf)
Page 40 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 49
Goal of this question Ensure proper placement of vaccines in the storage unit
Note These are all recommendations (best practices) not requirements
Helpful information bull Store vaccine in the middle of the compartment two to three inches away from the coils walls floor and cold air vent The temperature near the floor and walls of the unit differs from that in the middle of the compartment and the cold air vent can freeze refrigerated vaccines
4 Storage amp Handling Per Unit Vaccine Placement
Question 49 Look inside the unit to answer the questions below
A Are vaccines placed in the middle of the unit with space between vaccinesand the sideback of the unit to allow cold air to circulate
Yes No [O]
B Are vaccines stored in their original packages Yes No [O]
C Are there water bottles (for refrigerators) or frozen water bottles (forfreezers) in the unit
Yes No [O]
D Are vaccines store in the doors vegetable bins under or near cooling ventsor on the floor of the unit
Yes [O] No
E Is food being stored in the unit Yes [O] No
Review CDC Recommendation
Vaccines should be stored in their original manufacturer (or CDC centralized distributor) packaging They should be placed in the middle of the unit with space between the vaccines and the sideback of the unit to allow cold air to circulate Vaccines SHOULD NOT be stored in the doors vegetable bins or floor of the unit or under or near cooling vents and there should not be any food inthe unit Water bottles (for refrigerators) or frozen water bottles (for freezers) should be placed throughout each storage unit inorder to (1) stabilize or extend temperatures during a power outage and (2) to serve as physical blocks preventing the placementof vaccines in areas of the unit that are at higher risk for temperature excursions (such as in doors vegetable bins floor ornearunder cooling vents)
bull Vaccines should be kept in their original packaging to Protect them from light Help prevent medication errors by making labels easier to read Provide a moisture barrier that serves as insulation in case of an out-of-range temperature power outage door left open or mechanical failure Simplify managing vaccine inventory
bull Store water bottles in the doors on the floor and near the cold air vent in the refrigerator and frozen water bottles in the freezer to help maintain a stable temperature if there is a power failure and when the door is opened frequently Too many water bottles in the door can prevent the door from closing tightly Mark water bottles ldquoDo Not Drinkrdquo
bull Do not store vaccine in the door or drawers of the refrigerator or freezer Vegetable bins and crisper drawers should be removed from refrigerators or used to store other medical supplies or water bottles
bull If vaccine is stored in a household combination refrigeratorfreezer The top shelf should not be used for storing vaccine because the cold air vent blowing from the freezer will freeze vaccine located there If you must use the top shelf of this type of unit place water bottles underneath the cold air vent to prevent vaccine from being stored there It is recommended that only the refrigerator be used for vaccine storage and a separate stand-alone freezer be used to store frozen vaccine
bull Must not store food or beverages in the refrigerator or freezer because frequent opening of doors can lead to temperature variations that may affect vaccine viability There is also a risk of contaminating vaccines
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Guide (wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml) bull Vaccine Storage Tip Sheet on IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml)
IPI Advisor Manual | February 2017 Page 41
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 4104 Storage amp Handling Per Unit Disconnection from Power Source
Question 410 Ask the provider to demonstrate what measures are taken to ensure that vaccine storage units are notaccidentally physically disconnected from the power supply Which of the following describes the measure(s) taken on this unit
Note to Reviewer bull Large hospitals and healthcare systems may not have the ability to demonstrate labels on plugs or circuitbreakers In such cases verify that the practice has a comprehensive policy and standard operatingprocedures in place to prevent the vaccine storage unit from being physically disconnected from thepower supply
bull While back-up generators may ensure power to the overall facility this question ONLY addresses thevaccine storage unit being accidentally disconnected from the power source either through the plug orthe circuit breaker
Answers A ldquoDo not disconnectrdquo labels on the plug (Choose all that B ldquoWarningrdquo label on the circuit breaker box
apply) C Hard-wired (ie built-in) and has a ldquoDo not disconnectrdquo label on thecircuit breaker box D Hospital or large health care system with a comprehensive written policyand standard operating procedures detailing measures taken to preventvaccine storage units from being accidentally disconnected from the powersupply E No acceptable measures for preventing accidental disconnection frompower supply [X]
[X] The response is non-compliant if only A only B or E is selected
Review CDC Requirement
VFC providers must take steps to protect the power source for all vaccine storage equipment by means of having clear warninglabels on both the plug and the circuit breaker associated with all vaccine storage units Large hospitals and healthcare systems canmeet this requirement by demonstrating that they have comprehensive policies and standard operating procedures to preventvaccine storage units from being physically disconnected from the power supply
Goal of this question Decrease the chance that a vaccine storage unit will be accidently unplugged or power will be turned off while vaccine is in the unit This question addresses only what measures the site has taken to ensure the storage unit is not physically disconnected from its power source
If the site uses labels on the plugs and circuit breakers perform a visual inspection to assess whether the way the stickers are positioned make it clear and obvious to anyone that these units are not to be disconnected
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Do Not Unplug and Warning stickers are included in the folder or available to order on the For
Professionals Order Form (wwwhealthstatemnusdivsidepcimmunizeordermathtml)
Note Once you have completed the 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet for each unit return to the questionnaire to complete sections 5 and 6
Page 42 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
- -
Section 5 Storage amp Handling Site-Wide Question 51
5 Storage amp Handling Site Wide Discussion of Cost amp Quantity of Vaccine
Question 51 Have a discussion with the provider about the cost and quantity of VFC vaccines they are responsible for annually Address the points listed in the note to reviewer below
Note to Reviewer bull Vaccine Shipped (Required) Share the cost of VFC vaccines shipped to the provider in the last calendaryear to make sure the provider understands the contribution made by the VFC Program to their practiceFor new providers who do not have ldquocalendar yearrdquo data share either the actual cost of their currentinventory or use the cost of 10 VFC doses of each of the ACIP-recommended vaccines (approximately $7000) to help estimate their annual cost
bull Storage amp Handling (Required) Make sure the provider understands the cost of vaccines for which they are responsible when they make decisions about purchasing recommended vaccine storage and temperature monitoring equipment
Answer I have discussed with the provider the cost and quantity of vaccines ordered in the previous calendar year
Goal of this question Inform sites of the quantity and value of vaccines that they receive as part of the MnVFC program Providers often donrsquot realize the value of the vaccine in their unit This information is included on your clinic list and on the one page site-specific information
Helpful information bull This discussion must occur and the box on the questionnaire must be checked bull If there isnrsquot actual vaccine value information available tell the site that one vaccine order that includes a box of each of the ACIP recommended vaccines costs approximately $7000
bull MDH may not have specific information for individual sites if they receive vaccine from a central warehouse or pharmacy For those sites MDH will give you numbers for the whole system so you can discuss system wide data as appropriate If individual site information is also included it is usually just varicella-containing vaccines that must be shipped directly to the site
Question 52
5 Storage amp Handling Site Wide Dorm Style Units
Question 52 Determine whether the provider has any dorm-style units on site and answer the questions below
Note to Reviewer A dormitory-style refrigerator is a unit that has both refrigerator and freezer compartments behind a singleexterior door Dorm-style units also have an evaporator plate (cooling coil) which is usually located insidean icemaker compartment (freezer) within the refrigerator
A Does the provider have any dorm-style units that are used at any time tostore vaccines
Yes [X] No (Skip to question 53)
B Does the provider have sufficient space in existing compliant vaccinestorage units to store all vaccines without use of the dorm-style unit at any time
Yes No [X]
Review CDC Requirement
Dorm- and bar-style units are prohibited for vaccine storage Vaccines stored in dorm-style units are considered non-viable and must be returned to the centralized distributor CDC recommends the following vaccine storage unit types (in order of preference)pharmaceutical grade stand-alone or combination units (preferred) householdcommercial stand-alone unitshouseholdcommercial combination units using the refrigerator section only
Goal of this question Ensure no vaccine is stored in dorm-style units even for short periods of time Encourage them to label any units ldquoNo Vaccine Storage Allowedrdquo Vaccine stored in these units is considered non-viable If a site is using a dorm-style unit call the MnVFC program (651-201-5522)
Resource Section 8 in the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 43
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 535 Storage amp Handling Site Wide Storage Unit Space Availability
Question 53 Does the provider have sufficient room across storage units to store current stock as well as anyadditional stock acquired during peak season without overcrowding
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have sufficient storage space to accommodate vaccine stock at the busiest time of year without overcrowding
Goal of this question Ensure that sites have sufficient space in their units to maintain vaccines at the busiest time of year Overcrowding of vaccine limits air circulation and affects the unitrsquos ability to maintain stable temperatures
Helpful information bull Look for signs of overcrowding such as vaccines that are pushed up against the wall bins that are overflowing or storage units that are full during non-peak seasons
Discuss immediate actions if the unit is overcrowded Move some of their vaccines order less vaccine more frequently (once per month preferably) andor purchase another storage unit for overflow
Resource bull Section 8 MnVFC Policy and Procedure Manual
Page 44 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 545 Storage amp Handling Site Wide Expired Vaccines
Question 54 Look in each unit Are there expired vaccines in any of the vaccine storage units at this site
Answers (Choose one)
Yes [X] No
Review CDC Requirement
Vaccines should be rotated weekly and when a new shipment comes in so that longer-dated vaccines are stored behind shorter-dated vaccines If vaccines expire they can no longer be stored in the same storage unit with viable vaccines They must be placedin a container or bag clearly labeled ldquoDo not userdquo and separated from viable vaccines to prevent inadvertent use Expired vaccinemust be returned to the centralized distributor within six months of expiration
Goal of this question Ensure there is no expired vaccine in any storage unit
Helpful information bull Sites can prevent their stock from expiring by rotating vaccines every week andor when a new shipment arrives Longer-dated vaccines are stored towards the back of the unit and shorter-dated vaccines are up front
bull Pay attention to vaccines that expire within the next three months Consider transferring vaccine that will expire soon to another MnVFC-enrolled site that will use the vaccine preferably a site close by It is the transferring sitersquos responsibility to arrange the transfer of the vaccine Be sure to complete the MDH Vaccine Transfer Record form and send it to MDH If they are having difficulty finding a location to accept vaccine contact MDH
bull This is a great opportunity to educate sites about the MDH Nonviable Vaccine Form and the process for returning vaccine The VFC program does get some credit for taxes and fees on vaccine that is returned to the distribution center
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MDH Nonviable Vaccine Form and MDH Vaccine Transfer Record on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfcformshtml)
IPI Advisor Manual | February 2017 Page 45
The 2017 MnVFC Site Visit Paperwork Chapter 4
- -
-
Question 555 Storage amp Handling Site Wide Back up Thermometer
Question 55 Does the provider have a readily available back-up thermometer with a current and valid certificate ofcalibration testing
Note to Reviewer ldquoReadily availablerdquo means that the thermometer is available to perform twice-a-day monitoring for a unit asrequired CDC recommends that the back-up thermometer be maintained on site
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have a readily available back-up thermometer with a current and valid certificate of calibration testing Toprevent the certificates of calibration testing of the primary and back-up thermometers from expiring at the same time the date of calibration testing (or issue date) of the back-up thermometer should be different from the date of calibration testing (or issue date) of the primary thermometer As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meetsVFC program requirements
Goal of this question Ensure sites have one calibrated back-up thermometer onsite that is readily available in the event that the temperature monitoring device in unit fails transportation of vaccine is needed or there are other unexpected circumstances
Helpful information bull As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meets VFC Program requirements
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 56 5 Storage amp Handling Site Wide Preparation of Vaccine
Question 56 When does this provider prepare vaccine for administration to the patient
Note to Reviewer For mass vaccination clinics if one type of vaccine is offered providers may pre-draw up to 10 doses Ifusing pre-filled syringes pre-drawing also means activating the syringe by removing the needle guard orattaching a needle
Answers (Choose all that
apply)
Prepare dose immediately before administration Pre-draw doses for upcoming patients (in a regular clinicpractice) [O] Pre-draw up to 10 doses (in a mass-vaccination clinic) Pre-draw more than 10 doses (in a mass-vaccination clinic) [O] Other [O]
Review CDC Recommendation
CDC recommends preparing vaccines immediately prior to administration in order to assure viability of vaccine and prevent vaccinewastage Vaccines that are not administered immediately are at risk of exposure to temperatures outside of the required rangewhich can affect vaccine viability and ultimately can leave children unprotected against vaccine-preventable diseases
Goal of this question Discuss proper timing and preparation of vaccine(s) for administration These are recommendations not requirements
Helpful information bull Educate staff on the importance of preparing vaccine immediately before administration Pre-drawing of vaccines may lead to concerns related to vaccine viability potency sterility and wastage
Page 46 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 6 Inventory Question 61
6 Inventory Inventory Comparison
Question 61 Visually inspect storage units to determine if existing supply of vaccines proportionately mirrorspopulations served Choose the most accurate statement below
Note to Reviewer bull CDC recommends that providers maintain a four-week supply of inventory bull For this question do not take into account vaccine types that the provider does not order Here simply
make sure that overall the vaccines in the providerrsquos storage units are available in sufficient amounts toserve their patient population
Answers (Choose one)
The current vaccine inventory proportionately reflects the populations identified Only public stock is insufficient [X] Only private stock is insufficient [X] Both public and private stock are insufficient [X] Site uses the replacement method but does not appear to have enough vaccine for their population [X] Other [X]
Review CDC Requirement
VFC providers must order and stock routine vaccines in accordance with their patient population in order to prevent missedvaccination opportunities Having sufficient amounts of all stocks prevents the inadvertent use of VFC vaccines for non-VFC-eligiblepatients and vice versa
Goal of this question Assess whether the site is ordering appropriate quantities of vaccine for the population they serve at their site
Helpful information bull If the site sees 30 percent private-pay patients and 70 percent VFC the stock in their storage units should reflect that proportion If you donrsquot know you can ask the site about their population
bull This is meant to be a general assessment so in a big site if they have only a small amount of vaccine that may indicate an issue with vaccine management
bull CDC recommends smaller more frequent orders (ie monthly) rather than large orders to minimize the amount of vaccine loss if an incident occurs during shipment or in the storage unit Sites should not order more frequently than once a month
bull Sites using the replacement method will only have one stock but it should appear to be large enough for their population
bull Only assess the vaccine types that the site currently stocks in their unit We know there are sites that do not offer all ACIP-recommended vaccines for various reasons That issue will be addressed in question 62
IPI Advisor Manual | February 2017 Page 47
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 626 Inventory ACIP Recommended Vaccines
Question 62 Review providerrsquos current inventory to answer the questions below
A Does the provider offer all routine ACIP-recommendedvaccines for their patient population
Yes (Skip to question C) No [X] Offers all except varicella because direct ship ofvaccine is unavailable from manufacturer
B Which routine vaccines are NOT being offered DTaP Hepatitis A Hepatitis B HIB HPV Influenza Meningococcal
MMR Pneumococcal Polio Rotavirus TdapTd Varicella
C According to Immunization Program Policy does theprovider make accessible all non-routine ACIP-recommended vaccines for those VFC patients whomeet the criteria for receiving them
Yes (Skip to question 63) No [X]
D Which non-routine vaccines are NOT being offered Pneumococcal polysaccharide vaccine (PPSV23) Meningococcal Group B (MenB) Other
Review CDC Requirement
VFC providers agree to comply with immunization schedules dosages and contraindications that are established by the Advisory Committee on Immunization Practices (ACIP) for the vaccines identified and agreed upon in the Provider Agreement UNLESS bull In the VFC providers medical judgment and in accordance with accepted medical practice the VFC provider deems such
compliance to be medically inappropriate for the child bull The particular requirements contradict state law including laws pertaining to religious and other exemptions The VFC program entitles children to the following vaccines DTaP Hepatitis A Hepatitis B HIB HPV Influenza MeningococcalMMR Pneumococcal Polio Rotavirus TdapTd and Varicella VFC providers are also required to ensure that VFC-eligible children have access to non-routine vaccines as needed
Goal of this question Assess if the site is offering all the ACIP-recommended vaccines for the population they serve and these vaccines are in stock on the day of the visit It is important that every MnVFC-eligible child that comes to a providerrsquos office for an immunization is vaccinated
Helpful information bull The Advisory Committee on Immunization Practices (ACIP) is a group of medical and public health experts that develops recommendations on how to use vaccines to control diseases in the United States
bull Specialty providers are not required to offer all routine vaccines but should provide the vaccines appropriate for their population
bull If the site does not offer all routine ACIP-recommended vaccines appropriate for their population check the ldquoNordquo box in Part A then check the appropriate box(es) in Part B for any vaccines not offered Please contact MDH as this situation offers us the opportunity to provide education to the site
bull For non-routine vaccines they must either be in stock or the site must have an alternative protocol in the routine management plan that ensures these children have access when applicable
Resources bull IAC Diseases and Vaccines (wwwimmunizeorgvaccines) bull CDC Advisory Committee on Immunization Practices (ACIP) (wwwcdcgovvaccinesacipindexhtml)
Page 48 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 636 Inventory Separation of Stock
Question 63 Observe how the provider differentiates stock in each storage unit to answer the questions below
A Is it clear which vaccines belong to public stock andwhich belong to private stock
Yes No [X] Not applicable replacement site
B Is it clear which vaccines belong to VFC stock andwhich belong to UUAV stock
Yes No [X] Not applicable replacement site Not applicable not UUAV-enrolled site
Review CDC Requirement
In order to ensure that VFC vaccines are only administered to VFC-eligible children VFC providers that serve both VFC and non-VFCshyeligible children must maintain their vaccine inventories in such a way that they can clearly differentiate public stock from privatestock as well as VFC from other public stock
Goal of this question Assess whether the site can distinguish between MnVFC vaccine and private vaccine If they participate in the Uninsured and Underinsured Adult Vaccine (UUAV) program they should also be able to distinguish between MnVFC stock and UUAV stock Some sites use labels bins boxes etc to differentiate their stock If it is not clear how the site differentiates their stock discuss vaccine management with the staff For follow-up call MDH to discuss doing a follow-up site visit
Sites using the replacement method will not have separate stocksmdashthis is an approved alternative method for keeping track of vaccine
Resource bull Section 10 of the MnVFC Policy and Procedure Manual
IPI Advisor Manual | February 2017 Page 49
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
MnVFC Site Visit Storage and Handling Per Unit Answer Sheet 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet MnVFC PIN ___________________
Question number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
Temperature Monitoring Device Questions Questions 43 47 must be answered separately for the freezer and refrigerator if the unit is a combo Be sure to document responses in the appropriate column
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
All the questions on the Site Visit Storage amp Handling Per Unit Answer Sheet have been discussed previously in section 4 of this manual Use this sheet to record information about all the units at the site visit You will need one sheet for each unit If it is a combination unit (either pharmaceutical or household) you can record both sections on one sheet If they have stand-alone units use one sheet for each unit Do not enter the answers to the questions in section 4 of the questionnaire
If you need more information about any of the questions refer back to the main questionnairemdashthe complete question additional guidance including notes to the reviewer and the CDC requirements are there Also if the site is not meeting the requirement you will go back to the questionnaire to complete the ldquoActions if Non-compliantrdquo section including the root cause analysis and follow-up sections
When you have completed the assessment of all the storage units remember to go back to the questionnaire to complete sections 5 and 6
Page 50 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
ndash
ndash
MnVFC Provider Follow-up PlanThe goal of the Provider Follow-up Plan is to communicate with the site all of the VFC requirements any unmet requirements found during your site visit and the timeline for completing the required action The left hand column is a box to check for ldquoUnmetrdquo requirements
Helpful information bull The form can be used to review what the site is doing well and what they need to work on
bull For requirements that have specific documentation that needs to be sent to you use the notes section
2017 MnVFC Provider Follow-up Plan Site _______________________________________________ MnVFC PIN ____________ Date of Visit ___________
Thank you for participating in this MnVFC compliance site visit Please review this visit summary including follow-up actions and timelines for completion Unmet MnVFC requirements and recommendations have a checked box next to them The goal of this plan is to support you with successfully implementing the program and improving access to vaccines for VFC-eligible children
Unmet Question VFC Requirements Section 1 Changes to Key Staff
Q12 Change in the Medical Director Immunization Manager Vaccine Coordinator or back-upKey Staff must be communicated to the immunization program by emailing healthmnvfcstatemnus Changes Notes
Q12 Key staff must complete the annual training on VFC program requirements and print theAnnual Training certificate of completion Documentation Required Action
Staff that have not completed the MnVFC online training must complete it and send acopy of the certificate to the reviewer Training can be found on the MnVFC website (wwwhealthstatemnusvfc) Due date 1 month
Notes
Unmet Question VFC Requirements Section 2 Eligibility
Q21 Provider staff must possess a working knowledge of all VFC eligibility criteria and use thoseVFC Eligibility criteria to screen children prior to administering VFC vaccines
Categories Notes
bull This form provides documentation needed for follow-up actions when you send your thank you email
The second to last page of the Provider Follow-up Plan has a summary of the MnVFC program recommendations These are to remind the site about best practices they may want to improve upon even though they are not yet requirements of the program For example you could discuss the recommendation about storage units if they currently have a combination household unit and are using both sections
The last section is for your signature and the person you met with In most sites it will be the immunization manager or vaccine coordinator who signs the form unless the medical director attended the site visit You keep the original copy and the site will need to keep a copy for themselves
To be completed by the site visit reviewer
I acknowledge that a VFC site visit was performed on __________________ (visit date) The follow-up plan which includes a list of all current VFC program requirements and recommendations assessed during the visit and any required follow-up actions was provided at the end of the visit
Site visit reviewer
Phone
Reviewer Signature Date
To be completed by the provider
I acknowledge that our practice took part in the VFC site visit noted above I understand the findings of the visit and any required actions that must be taken by our office in order to meet VFC program requirements
Medical Director (or designee) Name Title
Medical Director (or designee) Signature Date
IPI Advisor Manual | February 2017 Page 51
The 2017 MnVFC Site Visit Paperwork Chapter 4
After the Site Visit Send a thank you email highlighting the unmet requirements documents you need from the site to resolve the issue(s) and the date you need them Make sure to include the link to the Site Visit Survey (httpssurveyvovicicomseashxs=56206EE334CE0B14)
Please refer to Chapter 3 for more information about future follow-up required after the visit including forms and documentation
Resource bull Sample Thank You letter on IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml)
Chapter 5
IPI Advisor Resource List MnVFC Program 651-201-5522
MnVFC wwwhealthstatemnusvfc
bull Separate Stock and Replacement Method Policies and Procedures Manuals bull Online trainings bull MnVFC Announcements sign up to receive them via email bull Ordering MDH vaccine bull MnVFC forms Screening forms Reporting forms Others MDH Nonviable Vaccine Form MDH Vaccine Transfer Record and Vaccine Borrowing Report
bull MnVFC promotional materials bull Immunization Billing Guidance for MnVFC and Immunization Billing Guidance for MnVFC Replacement Sites Immunization Practices Improvement Program (IPI) wwwhealthstatemnusdivsidepcimmunizeipi
bull IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml) bull IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml) IPI Resource Folder Contents (wwwhealthstatemnusdivsidepcimmunizeipiipifolderpdf)
Minnesota Immunization Information Connection (MIIC) wwwhealthstatemnusmiic
bull MIIC regions and regional coordinators
Clinical Practice MDH Immunization Program wwwhealthstatemnusimmunize
Got Your Shots News wwwhealthstatemnusdivsidepcnewslettersgys
MDH Immunization Information for Health Care Providers wwwhealthstatemnusdivsidepcimmunizehcp
bull Got Your Shots A Providers Guide to Immunization in Minnesota bull Vaccine protocols bull Forms for tracking patient immunizations bull Immunization schedules for Health Care Providers Immunization Action Coalition (IAC) wwwimmunizeorg
bull Ask the Experts bull VISs (Vaccine Information Statements and translations) bull Administration screening questions bull Medical management of vaccine reactions bull Order form for Californiarsquos Immunization Technique DVD Best Practices with Infants Children and Adults
Page 52 IPI Advisor Manual| February 2017
IPI Advisor Resource List Chapter 5
CDC ldquoPink Bookrdquo wwwcdcgovvaccinespubspinkbookindexhtml
CDC Advisory Committee on Immunization Practices (ACIP) wwwcdcgovvaccinesacip
CDC Vaccines and Immunizations wwwcdcgovvaccines
VAERS reporting httpvaershhsgovindex
Storage and Handling Got Your Shots Providers Guide ndash Managing Vaccine wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml
MnVFC Guide to Temperature Monitoring Devices wwwhealthstatemnusvfc
MDH Clinicianrsquos Vaccine Mishap Checklist wwwhealthstatemnusdivsidepcimmunizeipivaxchklstpdf
MDH Vaccine Storage Guide wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml
CDC Vaccine Storage and Handling Toolkit wwwcdcgovvaccinesrecsstoragetoolkit
You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Vaccine manufacturer phone numbers wwwcdcgovvaccinespubspinkbookdownloadsappendicesFcontact-info-manufactpdf
IAC Checklist for Safe Vaccine Handling and Storage wwwimmunizeorgcatgdp3035pdf
IAC Donrsquot Be Guilty of These Errors in Vaccine Storage and Handling wwwimmunizeorgcatgdp3036pdf
Additional Resources Print materials from MDH ndash order forms wwwhealthstatemnusdivsidepcimmunizeordermathtml
Vaccine Education Center ndash Childrenrsquos Hospital of Philadelphia wwwchopeduservicevaccine-education-centerhomehtml
California Department of Public Health ndash Interactive training on vaccine administration and storage and handling handout on transporting vaccine and how to package wwwezizorg
IPI Advisor Manual | February 2017 Page 53
IPI Advisor Resource List Chapter 5
CDC vaccine price list wwwcdcgovvaccinesprogramsvfcawardeesvaccine-managementprice-listindexhtml
Vaccine Information Statements (VIS) wwwcdcgovvaccineshcpvisindexhtml
CEU Opportunities CDC Immunization Education and Training wwwcdcgovvaccinesedindexhtml
Immunization You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Page 54 IPI Advisor Manual| February 2017
- Introduction
-
- Welcome to the Immunization Practice Improvement (IPI) Program
- Contact Information
-
- Chapter 1
- Requirements to Participate in the MnVFC Program
- Vaccines for Children Program
- Chapter 2
- Reimbursement for MnVFC Visits
- Types of Visits
- Your MnVFC Clinical CoordinatorPlanner
- New IPI Advisor Training Requirements
- Your Role as an IPI Advisor
- Reasons MDH Would Do All or Part of a Visit
- Chapter 3
- Future follow-up
- Conducting the Visit
- Preparing for the Visit
- Information for the Visit
- Site Visit Checklist
- Scheduling the Visit
- Chapter 4
- After the Site Visit
- MnVFC Provider Follow-up Plan
- MnVFC Site Visit Storage and Handling Per Unit Answer Sheet
- Section 6 Inventory
- Section 5 Storage amp Handling Site-Wide
- Section 4 Storage amp Handling Per Unit
- Section 3 Documentation
- Section 2 Eligibility
- Section 1 Provider Details
- The Site Visit Reviewer Legend
- MnVFC Site Visit Questionnaire
- Required Paperwork for Site Visits
- Chapter 5
-
IPI Advisors Chapter 2
Included with the list is a one-page information sheet for each site This contains the sitersquos demographic information vaccine coordinator and immunization manager listed in our records whether they are a separate stock or replacement site and the doses and cost of vaccine they received last year Confirm this information with the site and discuss their vaccine quantity and value as part of the questionnaire during your visit
All site visits must be completed by Sept 30 2017 If you think you will be unable to complete all your visits by then you will need to contact your MnVFC clinical coordinatorplanner to determine how the visit will be completed
New IPI Advisor Training Requirements New IPI advisors need to contact MDH before performing any MnVFC site visits on their own A MnVFC clinical coordinatorplanner will help you prepare to perform site visits They will
bull Guide your training See the Training Checklist for IPI Advisors on the IPI Program Resources (wwwhealthstate mnusdivsidepcimmunizeipiresourceshtml) page
bull Have you shadow them or another experienced IPI advisor on one or two site visits bull Shadow you on a visit or two bull Complete the training document
Your MnVFC Clinical CoordinatorPlanner Your MnVFC clinical coordinatorplanner is a MDH staff member that will help support you See who your clinical coordinatorplanner is on IPI Contact Information (wwwhealthstatemnusdivsidepc immunizeipicontacthtml)
The role of the MnVFC clinical coordinatorplanner bull Provide assistance to IPI advisors bull Perform enrollment visits for new sites that will be administering MnVFC vaccine bull Review MnVFC site visit paperwork for accuracy bull Conduct MnVFC site visits where necessary bull Provide additional education or follow-up with sites bull Provide assistance and guidance regarding MnVFC requirements and recommendations to sites bull Provide training to IPI advisors and staff at MnVFC-enrolled sites bull Field storage and handling incident calls
Types of Visits MnVFC Site Visit ndash also known as the Compliance Visit
CDC requires all state immunization programs to conduct site visits to all VFC providers MnVFC site visits are required every other year but sites can be visited on a yearly basis if needed The site visit objectives are to
Page 8 IPI Advisor Manual | February 2017
IPI Advisors Chapter 2
bull Complete the MnVFC site visit paperwork found on IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml)
bull Provide education about MnVFC program requirements and recommendations to site staff bull Ensure MnVFC program requirements are properly implemented and are being met bull Provide feedback and as necessary execute corrective action bull Follow-up on identified issues bull Notify your MnVFC clinical coordinatorplanner of issues that are not resolved by the due date
Follow-Up Visit
In-person follow-up visits will not be necessary for most MnVFC site visitsmdashonly those where significant issues are identified in the original visit If you are not able to complete part of the initial site visit because you found a storage and handling incident or you found multiple issues that need to be addressed a follow-up visit may be necessary Please contact the MnVFC clinical coordinatorplanner for approval and guidance for conducting a follow-up site visit
Educational Visit
Some sites may need more information and education than you can provide during a normal site visit This may be on topics related to immunizations immunization practices or administration or storage and handling issues These visits go beyond the sharing of pamphlets resources or information that is presented at a site visit Education visits should be conducted with a group and should focus on a topic that is identified during a site visit or requested by site staff Regularly scheduled meetings are not considered educational visits Educational visits need to be approved prior to the visit by the MnVFC clinical coordinatorplanner in order for you to receive reimbursement from the MnVFC program
Unscheduled (Unannounced) Storage amp Handling Visit
Unscheduled (unannounced) visits are not pre-scheduled with the site These visits require different paperwork and focus primarily on the storage and handling portion of a MnVFC site visit The MnVFC program is required to visit 5 percent to 10 percent of enrolled sites as unannounced visits each year Please discuss any unscheduled visits you would like to do with the MnVFC clinical coordinatorplanner You should plan to complete all of your regularly scheduled visits before doing any unscheduled visits
Enrollment Visit
All sites (including satellite clinics) that receive stock or supply MnVFC vaccine must have an enrollment visit that is conducted by MDH staff As an IPI advisor you may be asked to attend the enrollment visit This is an opportunity for you to start your relationship with the site and help with follow-up that may be necessary for the site to receive MnVFC vaccine Newly enrolled sites are scheduled for their first regular site visit within the first year (preferably within 3 to 6 months) and then every other year
IPI Advisor Manual | February 2017 Page 9
IPI Advisors Chapter 2
Reimbursement for MnVFC Visits Local public health agencies are paid for the site visits they conduct MDH will reimburse participating agencies only after we receive all of the required paperwork Paperwork submitted with incorrect or missing information may delay the reimbursement
IPI program reimbursement is processed on a quarterly basis and is processed in the month following each quarter through an electronic transfer of money Your agencycounty IPI advisor contact will receive an email notification of the reimbursement
Reimbursement rates are updated annually and available on the Contracts and Reimbursements (www healthstatemnusdivsidepcimmunizeipicontreimhtml) page
2017 MnVFC Site Visit Reimbursement Rates MnVFC Site Visit $400 Follow-up Visit$150 Education Visit$100 Unscheduled Visit$300
Reasons MDH Would Do All or Part of a Visit MDH may complete site visits or accompany you on a site visit if
bull The site is new to the MnVFC program (enrollment visit) bull The site has known issues or concerns regarding the MnVFC program especially if you are having difficulty resolving these issues
bull The site is refusing a site visit from local public health or yoursquore having a difficult time scheduling a visit
bull The site is part of tribal health or Indian Health Services bull MDH district epidemiologists will perform site visits at local health departments bull A new IPI advisor needs training from MDH staff bull Note MDH district epidemiologists will perform site visits at local health departments
Page 10 IPI Advisor Manual | February 2017
Chapter 3 Site Visits Scheduling the Visit
bull Check the information sheet or contact the site to confirm who the contact person is in charge of the MnVFC program In general this is the immunization manager or vaccine coordinator If the contact is no longer there ask for the person in charge of the sitersquos vaccines or the clinic manager They can usually direct you to the appropriate person You may want to follow a suggested phone script when contacting the site
Sample Phone Script for Scheduling a Visit
ldquoHello My name is _______ I am calling from ________ Health Department May I speak to (contact name) [If not available determine appropriate person to talk to or a better time to call back] I am calling to schedule a MnVFC site visit This visit will involve a review of immunization practices at your site We will look at vaccine administration storage and handling screening for eligibility and documentation of vaccinations It usually takes about two hours for a visit depending on the number of vaccine storage units you have Is there a day or time of day that works best for you
I have a pre-visit worksheet to send to you to help you prepare for the visit It contains information about what I will need at the visit such as temperature logs and immunization documentation information Completing this worksheet prior to me arriving will help the visit be more efficient Is there any other information that I can send to help you prepare for the visit
If you have any questions call me at ________ Thank you for your time and assistance I look forward to working with yourdquo
bull Arrange a date and time for the visit bull Let them know an approximate visit length Visits are usually around two hours long depending on the size of the site the number of vaccine storage units they have or if they have new staff
bull Request that key staff be present at the visit This could include the immunization manager vaccine coordinator immunization staff clinic manager nurse manager billing staff andor medical director
bull Inform your site contact that you will be sending them an email confirmation along with the MnVFC
Pre-Visit Worksheet
Site Visit Checklist Use the Site Visit Checklist on IPI Advisor Site Visit Materials (wwwhealthstatemnusdivs idepcimmunizeipisvmaterialshtml) to make sure all necessary steps are covered
MINNESOTA VA C CI N ES FO R CHI LD REN PROGRAM
Site Visit Checklist Date of visit Time
Site Name PIN
Address
Contact Phone
Complete Before the visit Comments
Review the clinic list Identify and prioritize which sites you will visit
Email or call to schedule a date and time for the visit Ask for the immunization manager or vaccine coordinator
Email appointment confirmation attach Pre-visit Worksheet and provide instructions for returning it prior to the visit (sample email on website) Include length of the visit and which staff should be present
Add site visit to Outlook calendar and reserve a car (if needed)
Review temp logs and Pre-visit Worksheet
Send a reminder email 2-3 days ahead of the visit
IPI Advisor Manual | February 2017 Page 11
i i li
Site Visits Chapter 3
Information for the Visit2017 MnVFC Pre-Visit Worksheet Site name MnVFC PIN
Address
Medical director Email
Immunization manager Phone
Vaccine coordinator Phone
Vaccine coordinator back-up Email
IPI Site Vis t Preparat on Check st
The staff listed have completed the MnVFC online training and printed a certification of completion Immunization Manager Vaccine coordinator Vaccine coordinator back-up
Have a copy of the most recent provider agreement
Check if the above listed staff have changed since the provider agreement was completed
Check all of the vaccines administered at your site and list the corresponding publication date for each VIS you give to patients
DTaP _____________ Hepatitis A _____________ Hepatitis B _____________ Hib _____________ HPV _____________
Influenza _____________ MCV4 _____________ MMR _____________ MMR-V _____________ PCV13 _____________
Polio _____________ Rotavirus _____________ Tdap _____________ Varicella _____________
Non-Routine Vaccines Men B__________ PPSV23 _____________ Td _____________
Vaccine administration fee charged for MnVFC eligible children is $
Have a Vaccine Management and Emergency Plan that has been reviewed and dated within the last year
Have the borrowing reports if applicable for the last 12 months available at the visit
Have an anaphylaxis protocol that is clearly posted and reviewed annually
Send an appointment reminder email and the MnVFC Pre-Visit Worksheet to the MnVFC contact A sample letter and the MnVFC Pre-Visit Worksheet can be found on the IPI Advisor Site Visit Materials (wwwhealthstate mnusdivsidepcimmunizeipisvmaterialshtml) page You can request that the MnVFC Pre-Visit Worksheet and temperature logs be sent to you prior to the visit for your review
Contact the site by phone or email one or two working days before the scheduled visit to confirm your appointment This is also a good time to ask for directions and parking information if you are not familiar with the site
Preparing for the Visit Review the site visit paperwork to familiarize yourself with the questions For most of the questions there is a ldquoNote to the reviewerrdquo These notes give helpful tips about the information you are looking for when asking this question It contains the rationale for the question and which resources to provide to the site to support the rationale Some sections also require immediate on-site actionsmdashthings you must do while you are at the site and some require future follow up
bull Print copies the of site visit paperwork bull Site visit forms are available on the IPI Advisor Site Visit Materials (wwwhealthstatemnusdivs idepcimmunizeipisvmaterialshtml) page 2017 MnVFC Site Visit Questionnaire 2017 MnVFC Site Visit Storage amp Handling per Unit Answer Sheet (print one for each stand-alone andor combination storage unit at the site) 2017 MnVFC Provider Follow-up Plan (print two copies)
bull Review any previous site visit paperwork that is available You should check in with MDH staff after your visits if the site continues to have the same issues as past visits
bull Also be sure to bring Your thermometers If the sitersquos certificate of calibration is expired or the probe is not properly placed place your thermometer in the storage unit when you arrive and read the temperature just prior to reviewing the site visit findings
The MnVFC folder with additional immunization resources you wish to add (see chapter 5) and the Vaccine Storage amp Handling magnet (to order email healthIPIinquiriesstatemnus) A copy of the appropriate MnVFC Policies and Procedures Manual found on the MnVFC website (wwwhealthstatemnusvfc) Appropriate temperature logs (Celsius or Fahrenheit) Site information sheet that contains the quantity and value of the vaccine distributed to the sitesystem
Page 12 IPI Advisor Manual | February 2017
Site Visits Chapter 3
Conducting the Visit Education is a large part of the MnVFC site visit Often approaching this visit as an exchange of information with the site is more successful than a ldquoregulatoryrdquo visit Putting the staff at ease answering their questions and making a plan to address issues that arise during the visit is more helpful than a ldquopassfailrdquo attitude Education will usually consist of providing the rationale for the requirement referring to the requirement in the MnVFC Policies and Procedures Manual and providing resources to help address the situation Some questions will require additional follow-up to assure the site has corrected the issue(s) and is meeting the MnVFC requirement(s) This will be addressed further in the follow-up section
Completing the Paperwork
There are three documents that you must complete for the MnVFC site visit bull 2017 MnVFC Site Visit Questionnaire bull 2017 MnVFC Site Visit Storage amp Handling per Unit Answer Sheet (one for each storage unit) bull 2017 MnVFC Provider Follow-up Plan (two copies or you may ask them to make you a copy of the completed form for their records)
Answer the questions on the MnVFC Site Visit Questionnaire based on how things are when you arrive at the site If they correct the issue during the visit you will still mark it as an unmet requirement and document how it was addressed during the visit
The ldquoAnswerrdquo field will contain all the possible answer choices for this question For most questions answer choices will be followed by the markings below
bull Answer choices with no marking mean the site meets the CDC requirement bull Answer choices marked with an [X] indicate that this specific answer choice is non-compliant with a CDC requirement
bull Answer choices marked with an [O] indicate that this specific answer choice is not aligned with a CDC recommendation
If you marked the box with the [X] which is non-compliant with the CDC requirement conduct a root cause analysis to determine the reason for non-compliance Root cause analysis is an important component to a successful site visit It is used to identify the cause of the problem and help to resolve the issue There are several possible root causes that can be identified Choose only one root cause
bull Human cause Personal beliefsopinions Does not understand rationale of requirement Lack of concern for compliance
bull Organizational cause Competing job assignmentsworkload Lack of (insufficient) staff to perform required duties Budget limitations (for required equipment) Lack of (insufficient) training of staff Lack of (insufficient) processesprotocols
IPI Advisor Manual | February 2017 Page 13
Site Visits Chapter 3
Once identified the root cause should be documented in the questionnaire including a brief explanation of why you chose that cause This allows for follow-up with the site and a way to help find improvements to meet the unmet requirement Complete any immediate on-site action These often require providing education and resources for the site Mark the box for each action taken If you provide additional resources or information you can use the notes section to indicate the additional items
ldquoFuture follow-uprdquo are actions the site needs to take to meet the requirements of the program Wersquoll go over more specific information about the site visit questionnaire in Chapter 4
Performing the Site Visit
As you become familiar with the MnVFC program and develop a relationship with your sites you will develop a visit pattern that works for you Here is one possible sequence for conducting MnVFC site visits
bull When you arrive at the site if you have a business card it is helpful to provide it to the front desk staff person
bull When you meet with the immunization manager andor vaccine coordinator introduce yourself and explain the expectations for the visit
bull Ask to see the temperature monitoring device(s) It must have a current certificate of calibration and the probe must be properly placed in the unit If it does not meet the requirements place your thermometer in the unit at the beginning of the visit so that it has sufficient time to reach an accurate temperature by the time you complete your assessment of the storage units
bull 2017 MnVFC Site Visit Questionnaire Ask all of the questions You may have to modify the order of the questions based on what is best for the site When you get to the storage and handling section (section 4) use the answer sheet(s) to document the answers to the questions for each storage unit that stores vaccine (MnVFC or private) Do not write answers in the questionnaire unless there is an unmet requirement Be sure to ask if there is vaccine stored anywhere else at any time at this location This includes a co-located pharmacy If so these additional units will need to be assessed as well If the site has a combination refrigeratorfreezer household unit and is using both sections discuss with them the recommendation (and probable future requirement) to have a separate freezer Refer to MDH if they have further questions or need more information Be prepared to address any storage and handling mishaps that you may find A copy of the
Clinicianrsquos Vaccine Mishap Checklist is with your visit materials and the Emergency Response Worksheet is in the MnVFC Policy and Procedure Manual If you are unsure how to handle the problem call the MnVFC program at 651-201-5522 during or after the visit
Page 14 IPI Advisor Manual | February 2017
Site Visits Chapter 3
Ending the Visit bull Fill out the two copies of the 2017 MnVFC Provider Follow-up Plan (or ask them to make a copy once it is completed for their records) Indicate if they have not met the requirement by checking the box in the ldquoUnmetrdquo column If they are not meeting requirements check the required actions Review the plan with them reinforcing the positive things they are doing as well as reviewing the required follow-up action(s) Give the site a copy of the Provider Follow-up Plan Keep the signed copy of the Provider Follow-up Plan to submit with your paperwork Do not leave a copy of the Site Visit Questionnaire at the site
bull Let them know you will be sending a thank you email that will summarize the site visit Included in the email will be a survey link you would appreciate them completing regarding the visit
After the Visit bull Send the site a thank you email There is a template thank you letter on the IPI Advisor Site Visit Materials (wwwhealthstate mnusdivsidepcimmunizeipisvmaterialshtml) page Be sure you include the issues that you identified and the timeline for their completion as well as the good things you found at the visit In the template letter be sure to include the survey link The survey is very brief ndash a few questions and space to write comments
bull Either transfer your MnVFC Site Visit Questionnaire and MnVFC Site Visit Storage amp Handling per Unit Answer Sheet information to the fillable version or submit the handwritten form to MDH
Documentation of the Visit
Paperwork must be submitted to MDH within 10 days of the visit in order to meet the federal VFC programrsquos reporting requirements Do not wait to complete your follow-up before submitting the site visit paperwork
Send the following documents to MDH bull 2017 MnVFC Site Visit Questionnaire (includes the cover sheet) bull 2017 MnVFC Site Visit Storage amp Handling per Unit Answer Sheet (one for each unit) bull 2017 MnVFC Provider Follow-up Plan (original signed plan)
Submit site visit materials to bull Email healthIPIinquiriesstatemnus (preferred) bull Mail IPI Program Specialist
Immunization Practices Improvement Program Minnesota Department of HealthPO Box 64975St Paul MN 55164-0975
IPI Advisor Manual | February 2017 Page 15
Site Visits Chapter 3
Future follow-up Follow-up is an important component of the site visit It helps us ensure that the unmet requirements have been corrected The questionnaire has different time periods for follow-up depending on the question Do not wait to complete your follow-up before submitting the site visit paperwork
When you complete the Follow-Up Form make sure to keep a copy for yourself MDH also keeps track of follow-up required and will remind you if follow-up has not been completed by the deadline Most follow-up can be done with a phone call or email In-person follow-up is rarely required and should be discussed with MDH before scheduling a follow-up visit
All requirements that need follow-up are identified with a [X] on the site visit paperwork and are listed on the MnVFC Provider Follow-up Plan
bull Follow-up with the site to see how they have resolved the unmet requirements bull Document your follow-up on the Follow-Up Form available on the IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml) page If follow-up was done via letter or email a copy can be attached to the Follow-Up Form
bull Send your Follow-Up Form to MDH (healthIPIinquiriesstatemnus) with supporting documents and emails
bull If a site is not responding to your requests regarding follow-up contact your MnVFC clinical coordinatorplanner They can help with additional follow-up as needed
Page 16 IPI Advisor Manual | February 2017
Chapter 4 The 2017 MnVFC Site Visit Paperwork This chapter will go through the required MnVFC site visit paperwork with notes about information or resources to help the site address questions or issues that may arise during the visit
The MnVFC site visit paperwork is available on the IPI Advisor Site Visit Materials (wwwhealthstate mnusdivsidepcimmunizeipisvmaterialshtml) page
Please download the paperwork shortly before your visit as there may be updates and changes and this will be the most up-to-date version of the questionnaire We will send out a Workspace message with major changes
Required Paperwork for Site Visits bull 2017 MnVFC Site Visit Questionnaire bull 2017 MnVFC Storage amp Handling Per Unit Answer Sheet ndash one for each unit assessed during site
visit bull 2017 MnVFC Provider Follow-up Plan ndash with provider signature
Make sure to include the sitersquos PIN on all your paperwork Please complete and submit your site visit paperwork as soon as possible after your visit It may be helpful to schedule some time into your calendar to complete your paperwork in the days following your visit Once you have completed the post-visit follow-up send in the Follow-Up Form with documentation of the follow-up actions Please do not wait until you have completed your follow-up before sending in your initial paperwork
MnVFC Site Visit Questionnaire The questionnaire includes these six sections 1 Provider details 2 Eligibility 3 Documentation 4 Storage amp handling per unit 5 Storage amp handling site-wide 6 Inventory
IPI Advisor Manual | February 2017 Page 17
Page 18 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
The Site Visit Reviewer Legend The legend explains the formatting of the 2017 questionnaire This includes information that will be helpful in completing the site visit
Site Visit Reviewer Guide Legend
Section Number Content Area
Question number This area will always contain the text of the question
Note to reviewer The note to reviewer contains information that is necessary for properly asking and assessing responses tothe question above This may include definitions of terms requirement details and other helpful tips
Answers This field will contain all the possible answer choices for this question For most questions answer choiceswill be followed by the markings below
Answer choices marked with an [X] indicate that this specific answer choice is non-compliant with a CDC requirement Answer choices marked with an [O] indicate that this specific answer choice is not aligned with a CDC
recommendation
Review CDC RequirementRecommendation
This field will be populated with the CDC requirementrecommendation associated with the given question
Actions if Non-Compliant
Root Cause Analysis As part of the site visit reviewers are required to assess and understand the reasons why a provider office isnon-compliant with VFC program requirements ndash this is a root cause analysis Reviewers must choose theone root cause that they believe most contributes to the non-compliance Upon establishing the root causethe reviewer must provide a clear explanation of hisher findings
Immediate Action These are actions that CDC requires reviewers to take on site during the visit
Future Follow-up These are future follow-up actions (with designated due dates) that are required of the reviewer andorprovider to remedy non-compliance Reviewers must complete all follow-up in accordance with CDCestablished deadlines
Notes Information you want the VFC program to be aware of or that explains your answer in detail
bull Note to reviewer These are notes to help you understand what the question is asking for and to clarify things you might want to know when asking or rephrasing the question
bull Answers This section helps you to know when the answer does not meet the CDC requirement [X] or recommendation [O] Whenever an answer with a [X] is checked the ldquoActions if Non-compliant section must be completed The recommendations are usually good teaching points about best practices andor future requirements of the VFC program
bull Review the CDC RequirementRecommendation This section provides a specific outline of the requirement or recommendation to give you information to use in talking with the site staff
bull Actions if Non-Compliant This section describes what to do if the site is not meeting a requirement Root cause analysis This section asks you to probe beyond the surface to find what is driving the non-compliance It is intended to help uncover reasons for recurring non-compliance issues identify additional training needs and inform reviewer follow-up actions Select only one root cause and explain the particular circumstances in the space ldquoExplanation of root causerdquo line provided If there appear to be multiple issues choose the one that most contributes to the non-compliance and describe all factors in the explanation Immediate actions A list of actions to take during the site visit to address the issue Future follow-up A list of actions to take after the site visit by the set deadline
bull Notes This section can be used for notes to yourself or to MDH
IPI Advisor Manual | February 2017 Page 19
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 1 Provider Details Questionnaire Coversheet
The first page of the questionnaire collects the demographic information for the site You can use this page to help prepare for the visit Most of the demographic information about the site should be on the site-specific document you received with your clinic list You will validate that this information is current at the time of the site visit It also helps to know if this is a separate stock site or a replacement site before the visit so you can bring a copy of the appropriate MnVFC Policies and Procedure Manual
2017 MnVFC Site Visit Questionnaire Date of visit _____________ Date forms sent to MDH ______________
Site Information
Site name MnVFC PIN
Address Separate Stock Replacement
City ZIP County
Medical Director Email
Immunization Manager Phone
Vaccine Coordinator Phone
Vaccine Coordinator back-up Email
Point of contact Phone
Personnel at site visit
On this page bull The date of the visit and the date when you send these forms to MDH This information helps us track the timeliness of our review and data entry process
bull The vaccine management method used by the site (replacement or separate stock) bull The name and email of the medical director (ideally this is the person who signed the MnVFC
Program Provider Agreement)bull Contact information for the immunization manager vaccine coordinator vaccine coordinator back-up and point-of-contact for this visit The immunization manager vaccine coordinator vaccine coordinator back-up roles are
described in the MnVFC Policies and Procedure Manual The vaccine coordinator back-up may be the immunization manager or another staff person depending on the size of the site and available personnel The Point of Contact is the person you set up the appointment with signs the Provider Follow-
up Plan and receives the follow-up email This may be one of the people listed above
The Post Visit Steps section is a reminder to you about what needs to done after the visit The Education on Immunization Best Practices for Sites section reminds you to provide the resource folder to the site
Page 20 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 12
1 Provider Details Changes to Key Staff
Question 12 Ask the provider about changes to key staff to answer the questions below
A (Choose all that
apply)
At the time of the visit is the Medical Director the same individual that signed the ProviderAgreement and are the Immunization Manager and Vaccine Coordinator the same asthose last reported to the program
Yes No the Medical Director has changed No the Immunization Manager has changed No the Vaccine Coordinator has changed
B (Choose one)
Were all changes communicated to theImmunization Program according to yourprogramrsquos policy
Yes or no staff changes No [X]
C (Choose one)
Based on review of the trainingdocumentation have the current Immunization Manager Vaccine Coordinator and back-up completed all required training
Yes No [X]
Review CDC Requirement
All changes in key staff must be communicated to the Immunization Program in the manner and timeframe defined by theImmunization Program Key staff include the Medical Director or equivalent who signed the Provider Agreement the Immunization Manager Vaccine Coordinator and the back-up VFC providers are required to ensure that all key staff are fully trained on VFC program requirements at all times All training must be documented
Goal of this question Determine if there are new staff in key positions at the site and to make sure staff are properly educated about the MnVFC program A This information can help you determine the level of knowledge and experience the staff have with the MnVFC program Follow-up throughout the visit can be tailored for various levels of staff experience Likewise you may identify additional training needs for new staff
B When sites notify us of changes in key personnel we update their information in MIIC and on the clinic lists We also send the new staff information for completing the online training and direct them to read the appropriate MnVFC Policies and Procedures Manual If the answer to this part is no update the demographic area of the questionnaire and inform the staff that in the future they must notify the MnVFC program (via email or phone) if the immunization manager or vaccine coordinator changes Resource Section 12 of the MnVFC Policies and Procedures Manual
C Annual training must be verified by looking at the certificates for the online training If the answer to this part is no refer the staff to complete the appropriate MnVFC online training found on the MnVFC website (wwwhealthstatemnusvfc) for their program (separate stockreplacement) for the current year and send you a copy of the certificate within 30 days
Resource bull Sections 12 and 14 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 21
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 2 Eligibility Question 21
Goal of this Question Assess whether staff correctly understand which patients are eligible for the MnVFC program Screening ensures that eligible children receive the vaccines that they are entitled to receive under the MnVFC program and helps to prevent fraud or abuse of the program
Children 18 years and younger in these
categories can receive MnVFC vaccine at any enrolled site bull Uninsured bull Enrolled in a Minnesota Health Care Program (MHCP) Medical Assistance (MA) or MinnesotaCare bull American Indian or Alaskan Native
The following categories are considered underinsured and are only MnVFC-eligible at local public health (LPH) Federally Qualified Health Centers (FQHC) Rural Health Centers (RHC) Indian Health Services (IHS) and tribal health clinics
bull Has health insurance that does not cover one or more vaccines as can be the case with newly licensed vaccines that arenrsquot yet covered (MnVFC-eligible for non-covered vaccines only)
bull Has health insurance that caps vaccine coverage at a certain amount Once that amount is reached the child is MnVFC-eligible
Children with insurance that does not cover vaccines until a deductible has been met are considered to be fully insured and are not MnVFC-eligible
Helpful information bull Sites are not required to verify the patientrsquos response to the screening questions For example if a patient states they lost their insurance the site does not need to call the patientrsquos insurance company to confirm
If the site cannot correctly describe the eligibility categories provide educational materialsresources on MnVFC eligibility requirements
Resources bull Patient Eligibility Screening Record on MnVFC Forms (wwwhealthstatemnusdivsidepc immunizemnvfcformshtml)
bull Section 1 of the MnVFC Policies and Procedures Manual
2 Eligibility VFC Eligibility Categories
Question 21 Was the individual responsible for determining patient VFC eligibility able to explain all the factors(including age) that make a child eligible to receive VFC vaccines
A Patient is less than 19 years of age Yes No [X]
B Patient is Medicaid-eligible Yes No [X]
C Patient is uninsured Yes No [X]
D Patient is underinsured Yes No [X]
E Patient is American Indian Yes No [X]
F Patient is Alaska Native Yes No [X]
Review CDC Requirement
VFC providers must possess a working knowledge of all VFC eligibility criteria and use those criteria to screen children prior toadministering VFC vaccines In order to receive VFC vaccine a patient must be under the age of 19 and must be at least one of the following (1) Medicaid-eligible (2) Uninsured (ie child has no health insurance) (3) Underinsured (ie child has health insurancebut coverage does not cover any or certain vaccines ndash underinsured children may only receive VFC vaccines in FQHCRHC ordeputized VFC provider offices and only for vaccines not covered by insurance) and (4) American Indian or Alaska Native (AIAN)
Page 22 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 22
2 Eligibility Billing Practices
Question 22 Is the individualdepartment responsible for billing able to clearly explain how they bill for both the costof vaccine and the vaccine administration fee for each of the eligibility categories below
A Medicaid-eligible Cost of Vaccine Do not bill ndash provided by VFC Admin Fee Bill Medicaid
Yes No [X]
B Uninsured Cost of Vaccine Do not bill ndash provided by VFC Admin Fee If billing can bill patient
Yes No [X]
C Underinsured Cost of Vaccine Do not bill ndash provided by VFC through FQHCsRHCs or deputized providers only all other providers cannotprovide VFC vaccine to underinsured patients Admin Fee If billing can bill patient
Yes No [X]
D American IndianAlaska Native(AIAN)
Cost of Vaccine Do not bill - provided by VFC unless patient is fully insured and parent chooses to use insurance Admin Fee If patient is Medicaid-eligible bill Medicaid if billingand patient is uninsuredunderinsured can bill patient if parentchooses to use private insurance for cost of vaccine billpatientinsurance
Yes No [X]
E Do individuals responsible for billing have access to the results of eligibility screening toensure proper billing
Yes No [X]
Review CDC Requirement
VFC providers must adhere to proper billing practices for vaccine administration fees and clearly understand that VFC vaccine isprovided at no cost to both the VFC provider and eligible children At no time should billing occur for the cost of VFC vaccine Whenadministering VFC vaccine providers should never bill two different ldquopayersrdquo (ie patient Medicaid insurance) for the samevaccine administration fee amount For Medicaid-eligible children Medicaid should be billed for the vaccine administration fee Forall other VFC-eligible populations the patient may be billed within the stateterritory cap established by the Centers for Medicareand Medicaid (CMS) However patients cannot be turned away or reported to collections for inability to pay the administration fee
Goal of this question Determine if the staff correctly understand how to bill patients that are eligible for the MnVFC program Billing appropriately ensures that children can receive low cost immunizations and the site is in compliance with the VFC program
bull If there is any indication that sites could be billing insurance companies or parents for VFC vaccines this should be investigated further
bull Most sites in Minnesota will bill Medicaid with the SL modifier ndash which indicates this is a Medicaid claim
bull The main point is to ensure the site is not billing uninsured children for VFC vaccine and are not charging them more than $2122 per vaccine for the administration fee
bull Non-compliance is usually unintentional and may be resolved with some training In rare cases it could be a glimpse into a larger problem where a site is intentionally billing for financial gain
bull If you think the site is billing inappropriately it is the responsibility of the IPI advisor to report concerns to MDH staff for further assistance
Resources bull Immunization Billing Guidance for MnVFC (wwwhealthstatemnusdivsidepcimmunizemnvfc billingtipshtml) or Immunization Billing Guidance for MnVFC Replacement Method Sites (www healthstatemnusdivsidepcimmunizemnvfcreplacementbillingtipsrephtml)
bull Section 2 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 23
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 232 Eligibility Vaccine Administration Fee
Question 23 Document the actual vaccine administration fee charged to non-Medicaid VFC-eligible patients (confirmwith billing department)
Answers Fee $ [X] Follow-up is required if the provider charges more than the fee cap establishedby the Centers for Medicare and Medicaid (CMS) for your stateterritory ($2122)
Review CDC Requirement
The VFC providerrsquos vaccine administration fee for non-Medicaid VFC-eligible children must not exceed the stateterritory vaccineadministration fee cap established by the Centers for Medicare and Medicaid (CMS) For current fee caps refer to Medicaid Program Payments for Services Furnished by Certain Primary Care Physicians and Charges for Vaccine Administration Under theVaccines for Children Program Final Rule (httpwwwgpogovfdsyspkgFR-2012-11-06pdf2012-26507pdf)
Goal of this question Ensure that sites are not charging more than the federal allowable vaccine administration fee of $2122
bull The Centers for Medicaid and Medicare (CMS) establishes a maximum fee that sites can charge to non-Medicaid-eligible VFC patients in each stateterritory for vaccine administration Health Plans usually negotiate this fee with the site but Medicaid will not pay more
bull If a parent cannot pay the vaccine administration fee the patient cannot be turned away or reported to collections VFC-eligible children must be vaccinated regardless of their ability to pay
bull If the person with whom you are conducting the site visit does not know the exact fee charged to non-Medicaid VFC-eligible patients ask to speak to someone who can verify the exact amount
bull If they are charging more than $2122 for the administration fee ndash please contact MDH staff for help with addressing this situation
Resources bull Immunization Billing Guidance for MnVFC (wwwhealthstatemnusdivsidepcimmunizemnvfc billingtipshtml) or Immunization Billing Guidance for MnVFC Replacement Method Sites (www healthstatemnusdivsidepcimmunizemnvfcreplacementbillingtipsrephtml)
bull Section 2 of the MnVFC Policies and Procedures Manual
Page 24 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 3 Documentation Question 31
3 Documentation Eligibility Screening amp Documentation
Question 31 To answer the questions below the provider must clearly demonstrate the patient intake processReview a minimum of 10 records that contain an immunization visit within the last 6 ndash 12 months
Note to Reviewer Criteria for Record Selection 1) Record selection must be completely random and the provider must not know prior to the visit which
records will be reviewed 2) Patient must have been 0-19 years of age at the last visit (Note Records of 19-year-old patients may
allow you to see if VFC vaccines are being used beyond the allowable age) 3) Must review a mix of public and private-pay patients (if applicable)
A Does the provider have a process that ensures that patients are screened forVFC eligibility at each visit and that screening results are documented at each visit
Yes No [X] (If no skip question F)
B Does the providerrsquos process ensure that staff administering vaccine know which vaccine stock to select from prior to drawing the vaccine
Yes No [X]
C Number of records reviewed If fewer than 10 records are reviewed select the reason why Provider does not have 10 patient records with immunizations in last 12 months
D Do all records contain date of the immunization visit and patientrsquos date of birth Yes No [X]
E Do all records contain the patientrsquos specific eligibility status associated with thedate of the immunization
Yes No [X]
F Do any of the providerrsquos records contain any evidence that the patient received vaccine for which they were not eligible
Yes [X] No
Review CDC Requirement
VFC providers must screen for and document VFC eligibility at each immunization visit Documentation must include the date of the visit and the childrsquos specific eligibility category VFC providers must use screening results to ensure that only VFC-eligible children receive VFC vaccine and that administration fees are billed for as appropriate Eligibility status must be readily available to staff administering vaccine prior to selecting which vaccine stock to use
Goal of this question Ensure the site is screening for eligibility and documenting the eligibility category in the medical record
Review a minimum of 10 records from within the last 6-12 months where the patient received an immunization You must review a mix of public and private pay patients (if applicable)
Random selection is important If the staff have pre-selected records for review do not use and identify additional randomly selected records to review
Helpful information bull Discuss upgrading the electronic health record to make documentation of VFC eligibility screening a required field Documenting eligibility screening in the immunization field promotes better MIIC data
bull Q 31 B Sites using the replacement method of vaccine management only have one stock so you will answer ldquoYesrdquo to this question
Resources bull Patient Eligibility Screening Record on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfcformshtml)
bull Section 1 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 25
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 32
3 Documentation Vaccine Dose Documentation
Question 32 Review a minimum of 10 patient immunization records from the last six months (or 12 months ifnecessary) to assess compliance with documentation requirements set forth by Statute 42 US Code 300aa-25 (See note to reviewer below)
Note to Reviewer Criteria for Record Selection 1) Record selection must be completely random the Provider must not know prior to the visit which records
will be reviewed 2) Patient must have been 0-19 years of age at the last visit (Note Records of 19-year-old patients may allow
you to see if VFC vaccines are being used beyond the allowable age)
Records are Compliant if they Contain ALL the Below Elements
bull Address of clinic where vaccine was administered bull Publication date of VIS bull Name of vaccine administered bull Name of vaccine manufacturer bull Date vaccine was administered bull Lot number bull Date VIS was given bull Name and title of person who administered the
vaccine
A Number of records reviewed
B Number of records that contain ALL required documentation elements
If fewer than 10 records are reviewed select the reason why Provider does not have 10 patient records with immunizations in last 12 months
[X] Follow-up isrequired if one ormore records do not meet requirements
Goal of this question Assess whether the site is documenting all required information in each patientrsquos medical record for every vaccine dose administered in accordance with the National Childhood Vaccine Injury Act
Resources bull Section 6 of the MnVFC Policies and Procedures Manual bull National Vaccine Injury Compensation Program (wwwhrsagovvaccinecompensation)
Question 33
3 Documentation Record Retention
Question 33 Is the provider able to demonstrate (preferred) or clearly describe how they maintain historical VFCeligibility documentation for three years
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers are required to maintain all records related to the VFC program for a minimum of three years (or longer if requiredby state law) and upon request make these records available for review VFC records include but are not limited to VFC screening and eligibility documentation billing records medical records that verify receipt of vaccine vaccine ordering records and vaccinepurchase and accountability records
Goal of this question Make sure the site understands they are required to keep all MnVFC screening documentation for at least three years either electronically or on paper This information should be available to you at the time of the visit and future visits
Resource bull Section 7 of the MnVFC Policies and Procedures Manual
Page 26 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 34
3 Documentation Borrowing Documentation
Question 34 Discuss borrowing practices with the provider to answer the questions below
Note to Reviewer bull To be considered ldquofully documentedrdquo documentation for each borrowed dose must include thefollowing information
Vaccine type borrowed Date the dose was administered Stock used (VFC or private) Reason appropriate vaccine stock was not used Patient name and date of birth Date dose was returned to appropriate stock
A Did the provider state that they had borrowed any vaccines (whetherdocumented or not) since the last VFC Compliance Site Visit
Yes No (If no skip to question 36)
B Are there any doses for which there is no documentation (ie provider hasindicated that doses were borrowed but cannot verify how many or why)
All doses are documented Some doses are not documented [X] No doses are documented [X] (if nodoses documented skip toquestion 36)
C Were all borrowed doses fully documented (See Note to Reviewer above) Yes No [X]
D Were all borrowed VFC doses either replaced or an order submitted to replacethe doses Yes No [X]
Review CDC Requirement
VFC providers are expected to maintain an adequate inventory of vaccine for VFC and non-VFC-eligible patients It is theresponsibility of the VFC provider to appropriately schedule and place vaccine orders VFC providers must also rotate stock to ensure timely use of short-dated vaccines Borrowing of vaccine between private and public inventories must be a rare unplanned occurrence and cannot serve as a replacement system for a VFC providerrsquos privately purchased vaccine inventory All instances ofborrowing must be properly documented reported and replaced
Goal of this question Assess vaccine accountability by verifying that children are receiving vaccine from the appropriate stock
Borrowing is when a fully insured child receives a dose of MnVFC vaccine or a MnVFC-eligible child receives a dose of private vaccine This should be a rare unplanned occurrence The site must document any borrowing of vaccine between stocks ideally on the VFC Borrowing Report Form If they are not currently using the form review it with them and encourage them to post it close to their vaccines It does not need to be sent to MDH but should be kept for 3 years and filed with their MnVFC documents to be reviewed whenever they have a regular or unscheduled (unannounced) site visit
Helpful information bull Understand and report on staffrsquos verbal (ie anecdotal) accounts of borrowing obtained during the visit Often sites do not know that what they do is considered borrowing or they think borrowing is acceptable and documentation isnrsquot needed so long as those vaccines are eventually replaced
bull Since sites using the replacement method only have one stock of vaccine they very rarely borrow bull This question asks for future follow-up in 6 months Make a note on your calendar and ask them to send you a copy of their borrowing reports for the previous 6 months with documentation of doses borrowed and replaced We will remind you if we donrsquot hear from you at the 6 month time frame Complete the Follow-up Form and attach the borrowing form
Resources bull Vaccine Borrowing Report on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfc formshtml)
bull Section 10 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 27
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 353 Documentation Borrowing Reasons
Question 35 Based on your discussion with the provider and a review of borrowing reports document the dosesborrowed for each reason and answer the questions below
Note to Reviewer bull Short-dated vaccines are doses that are likely to expire before they can be used bull Exchanging short-dated vaccines should only occur in practices that have a small number of private
patients
A Reasons for Borrowing a VFC Dose (Enter the number of _____ Private vaccine shipment delay (order placed on time but delay in shippingreceipt)
vaccine doses borrowed for each
reason in the spaces
_____ Private vaccine not useable on arrival (vials broken temperature monitor out of range) _____ Ran out of private vaccine between orders (provider orders not placed on time) [X]
provided) _____ Short-dated private dose was exchanged with VFC stock _____ Accidental use of VFC dose for a private patient (human error) _____ Replacement of private dose with VFC when insurance plan did not cover vaccine _____ OtherDocumented dose did not include reason for borrowing [X]
(Explanation Required) Reasons for Borrowing a Private Dose _____ VFC vaccine shipment delay (order placed on time but delay in shippingreceipt) _____ VFC vaccine not useable on arrival (vials broken temperature monitor out of range) _____ Ran out of VFC stock between orders (provider orders not placed on time) [X] _____ Short-dated VFC vaccine dose was exchanged with private dose _____ Accidental use of a private dose for a VFC-eligible patient (human error) _____ OtherDocumented dose did not include reason for borrowing [X]
(Explanation Required)
B Enter date range for instances of borrowing reviewed in the borrowing report Note If ldquoDate of earliest instancerdquo is not available use the date of the last VFC Compliance Visit If ldquoDate of last instancerdquo is not available use the date of thecurrent VFC Compliance Visit
Date of earliest instance
Date of last instance
C Does borrowing appear to be a routine practice Note To determine whether borrowing is a routine practice assess frequency of and repeating reasons for borrowing Examples Frequent accidental use of incorrect stock exchanging short-dated vaccines or issues with ordering and shipment
Yes [X] No
Goal of this question Determine the reasons why the site is borrowing vaccine
If sites are using the Vaccine Borrowing Report review the reasons for borrowing to help document borrowed VFC andor private doses If they have not been documenting borrowing on this report (or any other form) estimate their borrowing practices If you do not know the date range for their borrowing use the last site visit date to the current visit date The use of ldquootherrdquo as the reported reason for borrowing should be rare if ever and would require explanation and follow up
Helpful information bull Look to see if they routinely maintain insufficient amounts or types of vaccine to support their public and private patients that leads to borrowing
bull Pay attention to borrowing cases documented as ldquoaccidentalrdquo Repetitive accidental borrowing may indicate an issue with ordering processes or insufficient staff training
bull Borrowing is not a place to document wasted or lost doses bull The time period of the borrowing may give you clues about the root cause Were the borrowed doses concentrated in a short period or spread out across several months or a year Are all vaccine types being borrowed or just one
bull If borrowing seems to be an issue discuss vaccine management ordering procedures
Resources bull Vaccine Borrowing Report on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfc formshtml)
bull Section 10 in the MnVFC Policies and Procedures Manual
Page 28 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 36
3 Documentation Vaccine Management Plan
Question 36 Physically review the providerrsquos Vaccine Management Plan to answer the question below
A Does the provider have a Vaccine Management Plan Yes No [X] (If no skip to question 37)
B Does the plan list the current Immunization Manager Vaccine Coordinator andback-up
Yes No [X]
C Does the plan address proper vaccine storage and handling practices Yes No [X]
D Does the plan specify vaccine receiving procedures Yes No [X]
E Does the plan contain procedures for what to do with vaccine in the event of an emergency
Yes No [X]
F Does the plan contain procedures for vaccine ordering Yes No [X]
G Does the plan address inventory control (example stock rotation) Yes No [X]
H Does the plan address how to handle vaccine wastage Yes No [X]
I Does the plan address staff training and documentation on vaccine managementstorage amp handling
Yes No [X]
J Does the plan contain a review date that falls within the last 12 months Yes No [X]
K Has the plan been signed by the individual responsible for its content Yes No [X]
Review CDC Requirement
VFC providers must develop maintain and implement a Vaccine Management Plan for routine and emergency vaccinemanagement The plan must contain the current Vaccine Coordinator and back-up proper storage and handling practicesshipping and receiving procedures emergency procedures procedures for vaccine ordering inventory control (eg stock rotation)how to handle vaccine wastage and staff trainingdocumentation on vaccine management storage and handling The plan must bereviewedupdated annually or more frequently if changes occur A ldquoreview daterdquo and signature are required on all plans in order tovalidate that they are current
Goal of this question Evaluate the sitersquos plan for vaccine management It is especially important that they have a plan for emergency management of their vaccine in the case of equipment failure or power outage Encourage all sites to read and sign the MnVFC Policies and Procedures Manual and complete the emergency plan or be able to show you a plan of their own
If the provider is not able to physically show you the plan at the time of the visit or if the recorded review date is not within the last 12 months you must mark that this requirement is unmet The Vaccine Management Plan is important in times of emergency and it should be easy to access by any staff member at any time Encourage them to post the plan and put a copy with the packing supplies
Helpful information bull Encourage the site to fill in the ldquoImmunization Managerrdquo and ldquoVaccine Coordinatorrdquo fields in the
MnVFC Policies and Procedures Manual for their own referencebull The emergency plan in the manual can be reviewed from last year and included in this yearrsquos manual (with an updated signature and date) if there have not been any changes
bull If information in the plan is outdated site staff will not be well equipped to safely manage vaccines in the event of a power-outage or other emergency situation
bull If their institutional policy is only reviewed and updated every 3-4 years (as many are) the staff may need to sign the MnVFC Polices and Procedure Manual to meet this requirement
Resource Routine Vaccine Management Plan and Emergency Vaccine Management Plan in the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 29
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 37
3 Documentation VIS amp VAERS
Question 37 Review the providerrsquos Vaccine Information Statements (VISs) and discuss providerrsquos VAERS process toanswer the questions below
A Does the provider have readily available up-to-date VISs for all ACIP-recommendedvaccines relevant to the populations it serves
Yes No [X]
B Does the provider make a VIS available for patientsparents before eachvaccination
Yes No [X]
C Does the provider know how and when to report clinically significant adverseevents using VAERS
Yes No [X]
Review CDC Requirement
VFC providers are required to distribute the current Vaccine Information Statements (VIS) each time a vaccine is administered and maintain records in accordance with the National Childhood Vaccine Injury Act (NCVIA) which includes reporting clinicallysignificant adverse events to the Vaccine Adverse Event Reporting System (VAERS) For a list of current VISs visit CDCrsquos Vaccine Information Statements (httpwwwcdcgovvaccineshcpvis) website
Gal of this question Ensure the site has the most current VISs and is giving them to each patientparent before administering the vaccine in compliance with the federal law Parents must be educated about the vaccine their child will receive and be aware of possible contraindications and side-effects in order to make well-informed decisions about their childrsquos health
Helpful information bull Ask to see the sitersquos VISs to determine if they have an active protocol for giving VISs to parents Review to make sure they are current Ask if they know where and how to report vaccine adverse events
Resources bull Section 3 in the MnVFC Policies and Procedures Manual bull CDC Vaccine Information Statements (wwwcdcgovvaccineshcpvisindexhtml) Site may sign up for email updates for the current list of VIS publication dates for the most up-to-date version
bull IAC Itrsquos Federal Law You must give your patients current Vaccine Information Statements (wwwimmunizeorgcatgdp2027pdf)
bull VAERS (httpsvaershhsgovindex)
Question 38
3 Documentation Anaphylaxis protocol
Question 38 Does the site have an anaphylaxis protocol which is clearly posted near the emergency kit
Answers (Choose one)
Yes No [X]
Review CDC Requirement
An anaphylaxis protocol must be clearly posted in the area where vaccines are administered
Goal of this question Make sure site is prepared for a severe allergic or anaphylactic reaction to a vaccine
Resources bull Section 11 in the MnVFC Policies and Procedures Manual bull IAC protocols Child and Teens (wwwimmunizeorgcatgdp3082apdf) and Adults (wwwimmunize orgcatgdp3082pdf)
Page 30 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
i
i i i - li i i i i i l
Section 4 Storage amp Handling Per Unit The goal of this section is to assess vaccine storage
2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet practices in each unit at the site MnVFC PIN ___________________
The 2017 MnVFC Storage amp Handling Per Unit Answer Sheet is a worksheet to document the answers to the questions in this section for each unit (combination or stand-alone) Fill in the answers to the questions in Section 4 on the answer sheet not in the questionnaire
The answer sheet has an abbreviated form of each question If you need further information on that question refer back to the full questionnaire Also if you find an area where the site is not meeting the requirements you will need to go back to that question on the 2017 MnVFC Site Visit Questionnaire to complete ldquoActions if Non- compliantrdquo section including the root cause analysis and follow-up sections If there is a problem in more than one unit make a note on the questionnaire which unit you are referring to in the Notes section
Important You must fully assess any unit that may be used to store VFC vaccines even if there are no VFC vaccines there on the day of the visit If there are no vaccines and the site is not documenting twice a day temperatures discuss the need to ensure the unit is maintaining stable temperatures by monitoring for one week before placing vaccines in the unit
Quest on number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
for the freezer and e co umn
Temperature Monitoring Dev refr gerator f the un
ce Quest ons Quest ons 4 3 4 7 must be answered separate y t s a combo Be sure to document responses n the appropr at
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
44D Data downloaded and reviewed routinely (eg weekly)
Yes No [O]
Yes No [O]
45A Certificate of Calibration Testing Yes No [X]
Yes No [X]
45B Date of calibration
45C Date certificate expires [X] Follow-up is required if expired [X] Follow-up is required if expired
45D Certificate contains all necessary items
Yes No [X]
Yes No [X]
46 Probe properly placed Yes No [X]
Yes No [X]
47A Two temperature readings per day
Yes No [X]
Yes No [X]
47B Time date and name (or initials) for each reading
Yes No [X]
Yes No [X]
47C Current temperature and minmax temperatures (if
Current ________deg Minimum ________deg Maximum _deg
Current ________deg Minimum ________deg Maximum _deg
Sections 5 and 6 contain questions about storage and handling site wide and inventory It is helpful to keep those questions in mind as you assess the individual storage units Think about dorm-style units expired vaccine vaccine supply room for vaccine stocking all the recommended vaccines and separation of stock if appropriate
NOTE The sections that follow require reviewers to validate responses by looking at vaccine storage units temperaturemonitoring equipment and the vaccine inventory inside a unit bull For section 4 use a separate Storage amp Handling Per Unit Answer Sheet for each unit to document the findings (combination
units using both sections can be documented on the same answer sheet) bull When an unmet requirement is identified return to this questionnaire to complete the ldquoActions if Non-compliantrdquo section for
that question bull After you complete one answer sheet for each unit return to the questionnaire to complete sections 5 and 6 using information
you gathered while assessing the units The questions in sections 5 and 6 (Storage amp Handling Site-Wide and Inventory) are notunit-specific but do require that the response be based on a thorough assessment of all the providersrsquo units
4 Storage amp Handling Per Unit
Description On the Storage amp Handling Per Unit Answer Sheet place a name that will allow you or someone else from your program to easily identify this unit in the event of follow-up We recommend using Brand + Location(example Samsung - Room 123) Save each Storage amp Handling Per Unit Answer Sheet with the Brand + Location in the file name
(example SamsungRoom123doc)
IPI Advisor Manual | February 2017 Page 31
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 41
4 Storage amp Handling Per Unit Storage Unit Build amp Use
Question 41 Below select the build and use of the vaccine storage unit you are assessing
Note to Reviewer Dorm-style units Do not add dorm-style units here Dorm-style units will be addressed in section 5 Units storing only private stock You must review these storage units even if they contain only private stockat the time of the visit because that vaccine could be administered to VFC patients
A What type of unit is this A Stand-alone B Combination
B Select use if stand-alone A Freezer B Refrigerator
Select use if combination A Use both sections to store vaccine B Use freezer section only to store vaccine C Use refrigerator section only to store vaccine
Goal of this question Identify the unit you are evaluating The description asks you to create a unique name for this unit so that you will be able to identify the same unit in future site visits Put this description on the top of the answer sheet (ie make and location)
Helpful information bull A stand-alone unit is either a refrigerator or a freezer It does not have both sections in the unit bull If there is a combination unit note if the site uses both the refrigerator and freezer or only one section of the unit to store vaccines CDC does not recommend the use of either section or the freezer section only of combination household units
bull If your site utilizes the separate stock method of vaccine management you must review storage units even if they contain only private stock at the time of the visit because there is a chance that those vaccines could be administered (borrowed) to VFC-eligible patients
Page 32 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 424 Storage amp Handling Per Unit CDC Recommended Storage Units
Question 42 Below document the grade of the vaccine storage unit you are assessing
Note to Reviewer Pharmaceutical Also called ldquopurpose-builtrdquo these units are designed by the manufacturer specifically tostore vaccines or other biological materials Commercial Although usually intended to store food and beverages commercial units are often larger and more powerful than the household units found in most homes Though these units are intended to meet thehigher demands of larger facilities these units are not specifically built for the storage of biologicalmaterials Household (non-commercialdomestic) These units are usually smaller than commercial units and areintended for use in small offices and in homes ndash typically for food storage However just like commercialunits they are not designed specifically for the storage of biological materials Such units are usually available in common home supply stores
Answers (Choose one)
Select grade A Pharmaceutical B CommercialHousehold
[O] CDC does not recommend the use of both sections or the freezer section only of combination commercialhousehold units
Review CDC Recommendation
CDC recommends the following vaccine storage unit types (in order of preference) pharmaceutical grade stand-alone orcombination units (preferred) householdcommercial stand-alone units householdcommercial combination units using therefrigerator section only
Goal of this question Assess the grade and type of each storage unit bull Pharmaceutical grade units may be stand-alone or combination units that are often metal may have glass in the door for viewing inside often have an external digital temperature display and are manufactured by medical companies
bull Commercial or household units often look like your kitchen appliance have vegetablemeat drawers in the unit and are manufactured by household appliance companies
bull Occasionally you might find a medical grade unit which is usually a commercialhousehold unit with a lock and 3-prong plug These are still considered household units because of their ability to maintain proper temperatures and air flow Studies show that household stand-alone units are better able to maintain consistent temperatures than their combination counterparts Combination household units used to store vaccine in both sections of the unit is no longer recommended and may be prohibited in the future Combination household storage units that are having difficulty maintaining a cold enough freezer temperature and a warm enough refrigerator temperature should be replaced or a separate stand-alone freezer should be purchased
For frozen vaccines the most cost effective solution is for the site to purchase a small stand-alone freezer The site may need time to budget for a stand-alone storage unit
Resources bull Replacing Combination Household Units Tip Sheet on IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml)
IPI Advisor Manual | February 2017 Page 33
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 434 Storage amp Handling Per Unit Temperature Monitoring Device in the Unit
Question 43 Determine whether there is a temperature monitoring device in this section of the storage unit andanswer the questions
A Is there a temperature monitoring device in this section of thestorage unit
Yes No [X] (If no skip to question 47)
B Who is responsible for supplying the temperature monitoring device in this section of the storage unit Provider
Review CDC Requirement
Certificates of calibration testing provide confidence that the temperature monitoring device is measuring temperaturesaccurately All units storing VFC vaccines must have a calibrated temperature monitoring device with a current and valid certificateof calibration testing All certificates must contain modeldevice name or number serial number date of calibration testing (report or issue date) and Instrument Passed testingInstrument in Tolerance (Recommended uncertainty = +-05ordm C (+-1ordm F))
Goal of this question Assess whether there is a temperature monitoring device in the unit If the unit is not being monitored at all call MDH at 651-201-5522 for guidance
Helpful information bull This question does not ask whether the temperature monitoring device is working or the characteristics of the device These issues will be addressed later in the questionnaire
bull For part B the provider is always responsible for supplying the temperature monitoring device Even if their thermometer or data logger was originally from MDH it is their responsibility to ensure it is functional and calibrated
Resources bull Section 8 in the MnVFC Policies and Procedures Manual
Page 34 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 444 Storage amp Handling Per Unit CDC Recommended Temperature Monitoring Device
Question 44 Assess the temperature monitoring device in this section of the storage unit to answer the questionsbelow
A Is the temperature monitoring device a continuous monitoring and recordingdevice (eg data logger)
Yes No [O] (Skip D)
B Does the temperature monitoring device have a probe in buffered material Yes No [O]
C Does the temperature monitoring device have a digital display that can beeasily read from the outside of this unit
Yes No [O]
D Is data downloaded and reviewed routinely Yes No [O]
Review CDC Recommendation
As of Jan 1 2018 all VFC providers must use continuous temperature monitoring devices (eg data loggers) to monitor vaccinesthat will be administered to VFC-eligible children Routine review and accessibility of temperature data is critical for determining whether vaccine has been properly stored and for assessing usability of vaccine that was involved in a temperature excursion Tomeet VFC Program requirements the device must also be equipped with bull A temperature probe bull An active temperature display that can be easily read from the outside of the unit bull The capacity for continuous monitoring and recording capabilities where the data can be routinely downloaded
The following are additional recommended features for these devices bull Alarm for out-of-range temperatures bull Current minimum and maximum temperatures display bull Low battery indicator bull Accuracy of +- 1degF (05degC) bull Memory storage of at least 4000 readings bull User programmable logging interval (or reading rate) recommended at a maximum time interval of every 30 minutes bull Use of a probe that best reflects the temperature of the vaccine (such as a buffered probe)
Goal of this question Assess the temperature monitoring device in the storage unit Note that these are all recommendations not requirements at this time
This is a great teaching opportunity for sites who do not currently have a continuous temperature monitoring device Beginning Jan 1 2018 all units that store MnVFC vaccine will be required to have a continuous temperature monitoring device (ie a data logger or a continuous temperature monitoring system) Unlike a minmax thermometer a continuous temperature monitoring device provides detailed information on all temperatures recorded at pre-set intervals For excursions it can provide information on when a temperature went out-of-range for how long and what the temperatures were This is essential information that vaccine manufacturers need to know to assess the viability of the vaccine following an excursion
Helpful information bull Sites are required to monitor and record temperatures twice daily however temperature excursions can easily occur in the 12 hours or longer between readings Continuous temperature monitoring can help manufacturers determine vaccine viability
bull Continue to encourage sites to document and evaluate minimum and maximum temperatures the storage unit reached since the last reading and respond appropriately to out-of-range temperatures
IPI Advisor Manual | February 2017 Page 35
The 2017 MnVFC Site Visit Paperwork Chapter 4
bull It is recommended that sites download and review data weekly Discuss with sites that reviewing temperature monitoring device data also includes responding appropriately if they identify out-of-range temps
bull There is sometimes confusion about the difference between a data logger and a continuous temperature monitoring system Here are some differences
Data Loggers Continuous Monitoring Systems Have an external display similar to thermometers May or may not have an external display Have a detachable probe Probe is usually attached to transmitter Need to be plugged into the computer or cradle to download information on a regular schedule
Wirelessly sends data to computer system
Create a file of data that needs to be saved on the computer
Data is stored within the system not a separate file
Doesnrsquot allow documentation of twice a day temperature checks in the file
May allow documentation of twice a day temperature checks within the system
More about the 2018 requirement for a continuous temperature monitoring device
Required Features bull The continuous temperature monitoring device must have Continuous monitoring and recording capabilities to track and record temperatures over time The capacity to routinely download temperature data to a computer (recommended at least weekly) or wirelessly transmit data Detachable probe in a bottle filled with a thermal buffer (eg bio-safe glycol) if the data logger needs to be detached in order to download data Active temperature display
Recommended Features bull MnVFC recommends continuous temperature monitoring devices with Alarm for out-of-range temperatures Accuracy within +-1degF (+- 05degC) Low battery indicator Display of current minimum and maximum temperatures Memory storage of at least 4000 readings User programmable logging intervals (eg the user can set how often the device records the temperature)
Note that these are all currently recommendations not requirements yet
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Page 36 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 45
Goal of this question Ensure the temperature monitoring device is properly calibrated The certificate of calibration testing means that the device has been tested and it is accurately measuring temperatures within established testing limits The certificate of calibration ensures that the device meets all the required components
Helpful information bull The provider is always responsible for having a current certificate of calibration (or copy) on-site
bull To be considered ldquovalidrdquo a certificate of calibration must contain these required elements Modeldevice name or number Serial number
4 Storage amp Handling Per Unit Certificate of Calibration Testing
Review CDC Requirement
Certificates of calibration testing provide confidence that the temperature monitoring device is measuring temperaturesaccurately All units storing VFC vaccines must have a calibrated temperature monitoring device with a current and valid certificateof calibration testing All certificates must contain modeldevice name or number serial number date of calibration testing (report or issue date) and Instrument Passed testingInstrument in Tolerance (Recommended uncertainty = +-05ordm C (+-1ordm F))
Question 45
Note to Reviewer
A
B
C
D
E
Review the certificate of calibration testing for the temperature monitoring device in this section of the storage unit and answer the questions below
bull How to determine certificate of calibration testing expiration date 1) Identify the certificate issuecalibration date 2) Apply the Immunization Program-required frequency for calibration testing Example If the
issuecalibration date is 12312013 and Immunization Program policy requires testing every twoyears the expiration date is 12312015
bull Certificates must include all of the below bull ModelDevice Name or Number bull Serial Number bull Date of Calibration Testing (Report or Issue Date) bull Instrument Passed testing (Instrument in Tolerance)
Is there a certificate of calibration testing for the temperature monitoring Yes device in this section of the storage unit No [X]
What is the date of calibration for the temperature monitoring device in this section of the storage unit
What is the certificatersquos date of expiration based on ImmunizationProgram policy (See note to reviewer to determine expiration date) [X] Follow-up is required if
certificate is expired
Does the certificate contain all the necessary items listed in the Note to Yes Reviewer No [X]
Who is responsible for supplying the current and valid certificate of Provider calibration for this temperature monitoring device
Date of calibration testing (report or issue date) Note If there is no expiration date the certificate expires 2 years from the date of calibration Whether the instrument passed or failed testing (or instrument in tolerancenot in tolerance)
bull Recommended element Documented uncertainty of +- 1degF [05degC]
If these elements are present the certificate is considered valid If the certificate contains information about the recommended element or the entity that issued the certificate that is helpful but not required
To determine if a certificate of calibration testing was issued by an appropriate entity check to see if the certificate indicates one or more of these items (this is the wording used to help sites evaluate if their calibration is accurate but is not required on the certificate itself to be considered valid)
bull Conforms to ISO 17025 bull Performed by an ILACMRA Signatory body accredited laboratory You can review this list of the ILAC MRA and Signatories (httpilacorgilac-mra-and-signatories)
bull Traceable to the standards maintained by NIST bull Meets specifications and testing requirements for the American Society for Testing and Materials (ASTM) Standard E2877 tolerance Class F (le 05 degC) or better
bull Includes reference to another acceptable accuracy validation method such as comparison to other traceable reference standards or tests at thermometric fixed points
Note CDC recommends that certifications be issued for the entire monitoring unit (detachable probe data logger etc) and not individual certificates for each component
IPI Advisor Manual | February 2017 Page 37
The 2017 MnVFC Site Visit Paperwork Chapter 4
For 45 E the provider is always responsible for supplying the current and valid certificate of calibration for a temperature monitoring device
bull Tip If the temperature monitoring device has a sticker on the back with the calibration date the site can usually call the company who calibrated the device and get a copy of the certificate if they donrsquot have one
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 46 4 Storage amp Handling Per Unit Probe Placement
Question 46 Is the probe properly placed in this section of the storage unit
Note to Reviewer ldquoProperlyrdquo means that the probe in a commercial or household unit is placed in a central area of the unitdirectly with the vaccines Probes should not be placed in the doors near or against the walls close to vents or on the floor of the unit The only allowable exemption related to this requirement is for providerswho have pharmaceutical storage units (built for vaccine storage) that have either (1) a built-intemperature monitoring device OR (2) a dedicated port for the probe that dictates the placement of theprobe
Answers (Choose one)
Yes No [X]
Review CDC Requirement
The probe must be placed in a central area of the section of the storage unit directly with the vaccines in order to properly measurevaccine temperature The probe should not be placed in the door near or against the walls close to vents or on the floor of theunit For pharmaceutical units with a built-in temperature monitoring device or a dedicated port for a probe that is not in thecenter of the section of the storage unit consult your Immunization Program for guidance on placement
Goal of this question Make sure the temperature monitoring device is in the best location to accurately measure the temperature of the vaccines stored in the unit
Helpful information bull The probe of the temperature monitoring device should be placed directly with the vaccines in the middle of the unit The ONLY allowable exception is for pharmaceutical storage units that have either a built-in thermometer or a dedicated port for the probe that indicates placement of the probe
bull Temperatures can vary within the unit especially household units bull Call MDH at 651-201-5522 if you have questions
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Guide (wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml)
Page 38 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 474 Storage amp Handling Per Unit Temperature Documentation
Question 47 Review the temperature documentation over the past three months for this section of the storage unit todetermine whether the provider has a process in place for properly documenting temperatures twice aday Answer the questions below
A Are there two temperature readings recorded for this section of the storage unit per day
Yes No [X]
B Is there a time date and name (or initials) recorded for each reading Yes No [X]
C What is the current temperature and minmax temperatures (if available) inthis section of the storage unit Use the reviewerrsquos thermometer if the providerrsquos temperature monitoringdevice does not have a current valid certificate of calibration testing or the probe is not properly placed in this section of the storage unit
Current Temperature Minimum Temperature Maximum Temperature Fahrenheit Celsius
D Based on your review of the providerrsquos recent temperature documentationincluding the current temperature is this section of the storage unitmaintaining appropriate temperatures
Yes No [X] Not enough information [X]
Review CDC Requirement
Vaccines must be stored under appropriate temperatures as described in the package inserts at all times Acceptable temperature ranges vary by vaccine type and the range is 36deg F and 46deg F (2deg C and 8deg C) and for frozen vaccines the range is -58deg F and +5deg F (shy50deg C and -15deg C) Exposure to temperatures outside of those included in the package inserts could affect vaccine viability andultimately could leave children unprotected against vaccine-preventable diseases In order to maintain awareness of storage unittemperatures and ensure that vaccines are being stored at appropriate temperatures at all times VFC providers are required to monitor and document temperatures for all vaccine storage units at least twice a day Temperature documentation must contain (1) at least two temperature readings per day (2) the time and date of each reading and (3) the name (or initials) of the personwho assessed and recorded the readings CDC also recommends that VFC providers record the minimum and maximumtemperatures of each unit once each workday (preferably in the morning)
Goal of this question Ensure the temperature is being monitored twice daily is within the required range and documented correctly Use your thermometer to check the temperature if the sitersquos temperature monitoring devicersquos probe is not properly placed or there is not a current certificate of calibration Place your thermometer in the unit at the beginning of the visit to allow sufficient time to reach an accurate temperature The purpose of using your thermometer is to ensure the vaccine is being stored at the proper temperature not to ldquovalidaterdquo their reading
Question 47 D is an assessment question based on information you have learned during your visit You might answer ldquonot enough informationrdquo if the unit is new and they donrsquot have at least three months of data or if the unit is only used as overflow and they are inconsistent with temperature monitoring Mark ldquoNordquo if you have reason to believe the storage unit is not maintaining temperatures properly
Helpful information bull All sites must document temperatures twice a day every day the site is open even if they have a data logger or continuous monitoring system
bull Sites can document the information electronically with some continuous monitoring systems as long as it can show what the current temp is the date time and initials of the person checking ndash this needs to be someone at the site ndash not checking remotely or centrally for a large site or system The site must be able to produce these records during their site visit Reviewing these files can be a challenge due to large volumes and lots of paper
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Temperature Logs on Managing Vaccine (wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml)
IPI Advisor Manual | February 2017 Page 39
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 484 Storage amp Handling Per Unit Temperature Excursions
Question 48 In the event that a temperature excursion(s) occurred in this unit within the last three months requestand review documentation of actions taken to determine whether the provider has a process for properlyaddressing excursions Answer the questions below
A Were vaccines in this unit exposed to out-of-range temperatures in the lastthree months (including today)
Yes No (If no skip to question 49)
B Did the provider quarantine and label vaccines as ldquoDo not userdquo Yes No [X]
C Did the provider place vaccine in a unit where it can be stored under properconditions if applicable
Yes No [X]
D Did the provider contact the Immunization Program to report theexcursion
Yes No [X]
E Was the manufacturer contacted for documentation supporting theusability of the vaccine
Yes No [X]
Review CDC Requirement
The provider must document all excursions and actions taken including the following (1) Quarantine and label vaccines as ldquoDO NOTUSErdquo (2) Place vaccines in a unit where they can be stored under proper conditions (3) Contact the Immunization Program to report an excursion and (4) Contact the vaccine manufacturer to obtain documentation supporting the usability of the vaccine
Goal of this question Address any out-of-range temperatures (temperature excursions) identified in reviewing the last three months of temperature logs or during the site visit If there were any out-of-range temperatures did the site respond appropriately to the situation This is a great opportunity to discuss what to do in the event of an excursion The Clinicians Storage and Handling Mishap Checklist is in the IPI Site Visit information folder and is a good review of the process
Helpful information bull Sites need to know that an excursion does not automatically mean that exposed vaccines are non-viable or unusable Exposed vaccines must be quarantined (marked ldquoDo Not Userdquo) and stored under proper conditions until they have received information from vaccine manufacturers regarding the viability of the vaccine
bull Sites must inform MDH when an excursion occurs
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Clinicians Storage and Handling Mishap Checklist (wwwhealthstatemnusdivsidepcimmunize ipivaxchklstpdf)
Page 40 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 49
Goal of this question Ensure proper placement of vaccines in the storage unit
Note These are all recommendations (best practices) not requirements
Helpful information bull Store vaccine in the middle of the compartment two to three inches away from the coils walls floor and cold air vent The temperature near the floor and walls of the unit differs from that in the middle of the compartment and the cold air vent can freeze refrigerated vaccines
4 Storage amp Handling Per Unit Vaccine Placement
Question 49 Look inside the unit to answer the questions below
A Are vaccines placed in the middle of the unit with space between vaccinesand the sideback of the unit to allow cold air to circulate
Yes No [O]
B Are vaccines stored in their original packages Yes No [O]
C Are there water bottles (for refrigerators) or frozen water bottles (forfreezers) in the unit
Yes No [O]
D Are vaccines store in the doors vegetable bins under or near cooling ventsor on the floor of the unit
Yes [O] No
E Is food being stored in the unit Yes [O] No
Review CDC Recommendation
Vaccines should be stored in their original manufacturer (or CDC centralized distributor) packaging They should be placed in the middle of the unit with space between the vaccines and the sideback of the unit to allow cold air to circulate Vaccines SHOULD NOT be stored in the doors vegetable bins or floor of the unit or under or near cooling vents and there should not be any food inthe unit Water bottles (for refrigerators) or frozen water bottles (for freezers) should be placed throughout each storage unit inorder to (1) stabilize or extend temperatures during a power outage and (2) to serve as physical blocks preventing the placementof vaccines in areas of the unit that are at higher risk for temperature excursions (such as in doors vegetable bins floor ornearunder cooling vents)
bull Vaccines should be kept in their original packaging to Protect them from light Help prevent medication errors by making labels easier to read Provide a moisture barrier that serves as insulation in case of an out-of-range temperature power outage door left open or mechanical failure Simplify managing vaccine inventory
bull Store water bottles in the doors on the floor and near the cold air vent in the refrigerator and frozen water bottles in the freezer to help maintain a stable temperature if there is a power failure and when the door is opened frequently Too many water bottles in the door can prevent the door from closing tightly Mark water bottles ldquoDo Not Drinkrdquo
bull Do not store vaccine in the door or drawers of the refrigerator or freezer Vegetable bins and crisper drawers should be removed from refrigerators or used to store other medical supplies or water bottles
bull If vaccine is stored in a household combination refrigeratorfreezer The top shelf should not be used for storing vaccine because the cold air vent blowing from the freezer will freeze vaccine located there If you must use the top shelf of this type of unit place water bottles underneath the cold air vent to prevent vaccine from being stored there It is recommended that only the refrigerator be used for vaccine storage and a separate stand-alone freezer be used to store frozen vaccine
bull Must not store food or beverages in the refrigerator or freezer because frequent opening of doors can lead to temperature variations that may affect vaccine viability There is also a risk of contaminating vaccines
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Guide (wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml) bull Vaccine Storage Tip Sheet on IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml)
IPI Advisor Manual | February 2017 Page 41
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 4104 Storage amp Handling Per Unit Disconnection from Power Source
Question 410 Ask the provider to demonstrate what measures are taken to ensure that vaccine storage units are notaccidentally physically disconnected from the power supply Which of the following describes the measure(s) taken on this unit
Note to Reviewer bull Large hospitals and healthcare systems may not have the ability to demonstrate labels on plugs or circuitbreakers In such cases verify that the practice has a comprehensive policy and standard operatingprocedures in place to prevent the vaccine storage unit from being physically disconnected from thepower supply
bull While back-up generators may ensure power to the overall facility this question ONLY addresses thevaccine storage unit being accidentally disconnected from the power source either through the plug orthe circuit breaker
Answers A ldquoDo not disconnectrdquo labels on the plug (Choose all that B ldquoWarningrdquo label on the circuit breaker box
apply) C Hard-wired (ie built-in) and has a ldquoDo not disconnectrdquo label on thecircuit breaker box D Hospital or large health care system with a comprehensive written policyand standard operating procedures detailing measures taken to preventvaccine storage units from being accidentally disconnected from the powersupply E No acceptable measures for preventing accidental disconnection frompower supply [X]
[X] The response is non-compliant if only A only B or E is selected
Review CDC Requirement
VFC providers must take steps to protect the power source for all vaccine storage equipment by means of having clear warninglabels on both the plug and the circuit breaker associated with all vaccine storage units Large hospitals and healthcare systems canmeet this requirement by demonstrating that they have comprehensive policies and standard operating procedures to preventvaccine storage units from being physically disconnected from the power supply
Goal of this question Decrease the chance that a vaccine storage unit will be accidently unplugged or power will be turned off while vaccine is in the unit This question addresses only what measures the site has taken to ensure the storage unit is not physically disconnected from its power source
If the site uses labels on the plugs and circuit breakers perform a visual inspection to assess whether the way the stickers are positioned make it clear and obvious to anyone that these units are not to be disconnected
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Do Not Unplug and Warning stickers are included in the folder or available to order on the For
Professionals Order Form (wwwhealthstatemnusdivsidepcimmunizeordermathtml)
Note Once you have completed the 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet for each unit return to the questionnaire to complete sections 5 and 6
Page 42 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
- -
Section 5 Storage amp Handling Site-Wide Question 51
5 Storage amp Handling Site Wide Discussion of Cost amp Quantity of Vaccine
Question 51 Have a discussion with the provider about the cost and quantity of VFC vaccines they are responsible for annually Address the points listed in the note to reviewer below
Note to Reviewer bull Vaccine Shipped (Required) Share the cost of VFC vaccines shipped to the provider in the last calendaryear to make sure the provider understands the contribution made by the VFC Program to their practiceFor new providers who do not have ldquocalendar yearrdquo data share either the actual cost of their currentinventory or use the cost of 10 VFC doses of each of the ACIP-recommended vaccines (approximately $7000) to help estimate their annual cost
bull Storage amp Handling (Required) Make sure the provider understands the cost of vaccines for which they are responsible when they make decisions about purchasing recommended vaccine storage and temperature monitoring equipment
Answer I have discussed with the provider the cost and quantity of vaccines ordered in the previous calendar year
Goal of this question Inform sites of the quantity and value of vaccines that they receive as part of the MnVFC program Providers often donrsquot realize the value of the vaccine in their unit This information is included on your clinic list and on the one page site-specific information
Helpful information bull This discussion must occur and the box on the questionnaire must be checked bull If there isnrsquot actual vaccine value information available tell the site that one vaccine order that includes a box of each of the ACIP recommended vaccines costs approximately $7000
bull MDH may not have specific information for individual sites if they receive vaccine from a central warehouse or pharmacy For those sites MDH will give you numbers for the whole system so you can discuss system wide data as appropriate If individual site information is also included it is usually just varicella-containing vaccines that must be shipped directly to the site
Question 52
5 Storage amp Handling Site Wide Dorm Style Units
Question 52 Determine whether the provider has any dorm-style units on site and answer the questions below
Note to Reviewer A dormitory-style refrigerator is a unit that has both refrigerator and freezer compartments behind a singleexterior door Dorm-style units also have an evaporator plate (cooling coil) which is usually located insidean icemaker compartment (freezer) within the refrigerator
A Does the provider have any dorm-style units that are used at any time tostore vaccines
Yes [X] No (Skip to question 53)
B Does the provider have sufficient space in existing compliant vaccinestorage units to store all vaccines without use of the dorm-style unit at any time
Yes No [X]
Review CDC Requirement
Dorm- and bar-style units are prohibited for vaccine storage Vaccines stored in dorm-style units are considered non-viable and must be returned to the centralized distributor CDC recommends the following vaccine storage unit types (in order of preference)pharmaceutical grade stand-alone or combination units (preferred) householdcommercial stand-alone unitshouseholdcommercial combination units using the refrigerator section only
Goal of this question Ensure no vaccine is stored in dorm-style units even for short periods of time Encourage them to label any units ldquoNo Vaccine Storage Allowedrdquo Vaccine stored in these units is considered non-viable If a site is using a dorm-style unit call the MnVFC program (651-201-5522)
Resource Section 8 in the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 43
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 535 Storage amp Handling Site Wide Storage Unit Space Availability
Question 53 Does the provider have sufficient room across storage units to store current stock as well as anyadditional stock acquired during peak season without overcrowding
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have sufficient storage space to accommodate vaccine stock at the busiest time of year without overcrowding
Goal of this question Ensure that sites have sufficient space in their units to maintain vaccines at the busiest time of year Overcrowding of vaccine limits air circulation and affects the unitrsquos ability to maintain stable temperatures
Helpful information bull Look for signs of overcrowding such as vaccines that are pushed up against the wall bins that are overflowing or storage units that are full during non-peak seasons
Discuss immediate actions if the unit is overcrowded Move some of their vaccines order less vaccine more frequently (once per month preferably) andor purchase another storage unit for overflow
Resource bull Section 8 MnVFC Policy and Procedure Manual
Page 44 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 545 Storage amp Handling Site Wide Expired Vaccines
Question 54 Look in each unit Are there expired vaccines in any of the vaccine storage units at this site
Answers (Choose one)
Yes [X] No
Review CDC Requirement
Vaccines should be rotated weekly and when a new shipment comes in so that longer-dated vaccines are stored behind shorter-dated vaccines If vaccines expire they can no longer be stored in the same storage unit with viable vaccines They must be placedin a container or bag clearly labeled ldquoDo not userdquo and separated from viable vaccines to prevent inadvertent use Expired vaccinemust be returned to the centralized distributor within six months of expiration
Goal of this question Ensure there is no expired vaccine in any storage unit
Helpful information bull Sites can prevent their stock from expiring by rotating vaccines every week andor when a new shipment arrives Longer-dated vaccines are stored towards the back of the unit and shorter-dated vaccines are up front
bull Pay attention to vaccines that expire within the next three months Consider transferring vaccine that will expire soon to another MnVFC-enrolled site that will use the vaccine preferably a site close by It is the transferring sitersquos responsibility to arrange the transfer of the vaccine Be sure to complete the MDH Vaccine Transfer Record form and send it to MDH If they are having difficulty finding a location to accept vaccine contact MDH
bull This is a great opportunity to educate sites about the MDH Nonviable Vaccine Form and the process for returning vaccine The VFC program does get some credit for taxes and fees on vaccine that is returned to the distribution center
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MDH Nonviable Vaccine Form and MDH Vaccine Transfer Record on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfcformshtml)
IPI Advisor Manual | February 2017 Page 45
The 2017 MnVFC Site Visit Paperwork Chapter 4
- -
-
Question 555 Storage amp Handling Site Wide Back up Thermometer
Question 55 Does the provider have a readily available back-up thermometer with a current and valid certificate ofcalibration testing
Note to Reviewer ldquoReadily availablerdquo means that the thermometer is available to perform twice-a-day monitoring for a unit asrequired CDC recommends that the back-up thermometer be maintained on site
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have a readily available back-up thermometer with a current and valid certificate of calibration testing Toprevent the certificates of calibration testing of the primary and back-up thermometers from expiring at the same time the date of calibration testing (or issue date) of the back-up thermometer should be different from the date of calibration testing (or issue date) of the primary thermometer As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meetsVFC program requirements
Goal of this question Ensure sites have one calibrated back-up thermometer onsite that is readily available in the event that the temperature monitoring device in unit fails transportation of vaccine is needed or there are other unexpected circumstances
Helpful information bull As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meets VFC Program requirements
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 56 5 Storage amp Handling Site Wide Preparation of Vaccine
Question 56 When does this provider prepare vaccine for administration to the patient
Note to Reviewer For mass vaccination clinics if one type of vaccine is offered providers may pre-draw up to 10 doses Ifusing pre-filled syringes pre-drawing also means activating the syringe by removing the needle guard orattaching a needle
Answers (Choose all that
apply)
Prepare dose immediately before administration Pre-draw doses for upcoming patients (in a regular clinicpractice) [O] Pre-draw up to 10 doses (in a mass-vaccination clinic) Pre-draw more than 10 doses (in a mass-vaccination clinic) [O] Other [O]
Review CDC Recommendation
CDC recommends preparing vaccines immediately prior to administration in order to assure viability of vaccine and prevent vaccinewastage Vaccines that are not administered immediately are at risk of exposure to temperatures outside of the required rangewhich can affect vaccine viability and ultimately can leave children unprotected against vaccine-preventable diseases
Goal of this question Discuss proper timing and preparation of vaccine(s) for administration These are recommendations not requirements
Helpful information bull Educate staff on the importance of preparing vaccine immediately before administration Pre-drawing of vaccines may lead to concerns related to vaccine viability potency sterility and wastage
Page 46 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 6 Inventory Question 61
6 Inventory Inventory Comparison
Question 61 Visually inspect storage units to determine if existing supply of vaccines proportionately mirrorspopulations served Choose the most accurate statement below
Note to Reviewer bull CDC recommends that providers maintain a four-week supply of inventory bull For this question do not take into account vaccine types that the provider does not order Here simply
make sure that overall the vaccines in the providerrsquos storage units are available in sufficient amounts toserve their patient population
Answers (Choose one)
The current vaccine inventory proportionately reflects the populations identified Only public stock is insufficient [X] Only private stock is insufficient [X] Both public and private stock are insufficient [X] Site uses the replacement method but does not appear to have enough vaccine for their population [X] Other [X]
Review CDC Requirement
VFC providers must order and stock routine vaccines in accordance with their patient population in order to prevent missedvaccination opportunities Having sufficient amounts of all stocks prevents the inadvertent use of VFC vaccines for non-VFC-eligiblepatients and vice versa
Goal of this question Assess whether the site is ordering appropriate quantities of vaccine for the population they serve at their site
Helpful information bull If the site sees 30 percent private-pay patients and 70 percent VFC the stock in their storage units should reflect that proportion If you donrsquot know you can ask the site about their population
bull This is meant to be a general assessment so in a big site if they have only a small amount of vaccine that may indicate an issue with vaccine management
bull CDC recommends smaller more frequent orders (ie monthly) rather than large orders to minimize the amount of vaccine loss if an incident occurs during shipment or in the storage unit Sites should not order more frequently than once a month
bull Sites using the replacement method will only have one stock but it should appear to be large enough for their population
bull Only assess the vaccine types that the site currently stocks in their unit We know there are sites that do not offer all ACIP-recommended vaccines for various reasons That issue will be addressed in question 62
IPI Advisor Manual | February 2017 Page 47
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 626 Inventory ACIP Recommended Vaccines
Question 62 Review providerrsquos current inventory to answer the questions below
A Does the provider offer all routine ACIP-recommendedvaccines for their patient population
Yes (Skip to question C) No [X] Offers all except varicella because direct ship ofvaccine is unavailable from manufacturer
B Which routine vaccines are NOT being offered DTaP Hepatitis A Hepatitis B HIB HPV Influenza Meningococcal
MMR Pneumococcal Polio Rotavirus TdapTd Varicella
C According to Immunization Program Policy does theprovider make accessible all non-routine ACIP-recommended vaccines for those VFC patients whomeet the criteria for receiving them
Yes (Skip to question 63) No [X]
D Which non-routine vaccines are NOT being offered Pneumococcal polysaccharide vaccine (PPSV23) Meningococcal Group B (MenB) Other
Review CDC Requirement
VFC providers agree to comply with immunization schedules dosages and contraindications that are established by the Advisory Committee on Immunization Practices (ACIP) for the vaccines identified and agreed upon in the Provider Agreement UNLESS bull In the VFC providers medical judgment and in accordance with accepted medical practice the VFC provider deems such
compliance to be medically inappropriate for the child bull The particular requirements contradict state law including laws pertaining to religious and other exemptions The VFC program entitles children to the following vaccines DTaP Hepatitis A Hepatitis B HIB HPV Influenza MeningococcalMMR Pneumococcal Polio Rotavirus TdapTd and Varicella VFC providers are also required to ensure that VFC-eligible children have access to non-routine vaccines as needed
Goal of this question Assess if the site is offering all the ACIP-recommended vaccines for the population they serve and these vaccines are in stock on the day of the visit It is important that every MnVFC-eligible child that comes to a providerrsquos office for an immunization is vaccinated
Helpful information bull The Advisory Committee on Immunization Practices (ACIP) is a group of medical and public health experts that develops recommendations on how to use vaccines to control diseases in the United States
bull Specialty providers are not required to offer all routine vaccines but should provide the vaccines appropriate for their population
bull If the site does not offer all routine ACIP-recommended vaccines appropriate for their population check the ldquoNordquo box in Part A then check the appropriate box(es) in Part B for any vaccines not offered Please contact MDH as this situation offers us the opportunity to provide education to the site
bull For non-routine vaccines they must either be in stock or the site must have an alternative protocol in the routine management plan that ensures these children have access when applicable
Resources bull IAC Diseases and Vaccines (wwwimmunizeorgvaccines) bull CDC Advisory Committee on Immunization Practices (ACIP) (wwwcdcgovvaccinesacipindexhtml)
Page 48 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 636 Inventory Separation of Stock
Question 63 Observe how the provider differentiates stock in each storage unit to answer the questions below
A Is it clear which vaccines belong to public stock andwhich belong to private stock
Yes No [X] Not applicable replacement site
B Is it clear which vaccines belong to VFC stock andwhich belong to UUAV stock
Yes No [X] Not applicable replacement site Not applicable not UUAV-enrolled site
Review CDC Requirement
In order to ensure that VFC vaccines are only administered to VFC-eligible children VFC providers that serve both VFC and non-VFCshyeligible children must maintain their vaccine inventories in such a way that they can clearly differentiate public stock from privatestock as well as VFC from other public stock
Goal of this question Assess whether the site can distinguish between MnVFC vaccine and private vaccine If they participate in the Uninsured and Underinsured Adult Vaccine (UUAV) program they should also be able to distinguish between MnVFC stock and UUAV stock Some sites use labels bins boxes etc to differentiate their stock If it is not clear how the site differentiates their stock discuss vaccine management with the staff For follow-up call MDH to discuss doing a follow-up site visit
Sites using the replacement method will not have separate stocksmdashthis is an approved alternative method for keeping track of vaccine
Resource bull Section 10 of the MnVFC Policy and Procedure Manual
IPI Advisor Manual | February 2017 Page 49
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
MnVFC Site Visit Storage and Handling Per Unit Answer Sheet 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet MnVFC PIN ___________________
Question number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
Temperature Monitoring Device Questions Questions 43 47 must be answered separately for the freezer and refrigerator if the unit is a combo Be sure to document responses in the appropriate column
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
All the questions on the Site Visit Storage amp Handling Per Unit Answer Sheet have been discussed previously in section 4 of this manual Use this sheet to record information about all the units at the site visit You will need one sheet for each unit If it is a combination unit (either pharmaceutical or household) you can record both sections on one sheet If they have stand-alone units use one sheet for each unit Do not enter the answers to the questions in section 4 of the questionnaire
If you need more information about any of the questions refer back to the main questionnairemdashthe complete question additional guidance including notes to the reviewer and the CDC requirements are there Also if the site is not meeting the requirement you will go back to the questionnaire to complete the ldquoActions if Non-compliantrdquo section including the root cause analysis and follow-up sections
When you have completed the assessment of all the storage units remember to go back to the questionnaire to complete sections 5 and 6
Page 50 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
ndash
ndash
MnVFC Provider Follow-up PlanThe goal of the Provider Follow-up Plan is to communicate with the site all of the VFC requirements any unmet requirements found during your site visit and the timeline for completing the required action The left hand column is a box to check for ldquoUnmetrdquo requirements
Helpful information bull The form can be used to review what the site is doing well and what they need to work on
bull For requirements that have specific documentation that needs to be sent to you use the notes section
2017 MnVFC Provider Follow-up Plan Site _______________________________________________ MnVFC PIN ____________ Date of Visit ___________
Thank you for participating in this MnVFC compliance site visit Please review this visit summary including follow-up actions and timelines for completion Unmet MnVFC requirements and recommendations have a checked box next to them The goal of this plan is to support you with successfully implementing the program and improving access to vaccines for VFC-eligible children
Unmet Question VFC Requirements Section 1 Changes to Key Staff
Q12 Change in the Medical Director Immunization Manager Vaccine Coordinator or back-upKey Staff must be communicated to the immunization program by emailing healthmnvfcstatemnus Changes Notes
Q12 Key staff must complete the annual training on VFC program requirements and print theAnnual Training certificate of completion Documentation Required Action
Staff that have not completed the MnVFC online training must complete it and send acopy of the certificate to the reviewer Training can be found on the MnVFC website (wwwhealthstatemnusvfc) Due date 1 month
Notes
Unmet Question VFC Requirements Section 2 Eligibility
Q21 Provider staff must possess a working knowledge of all VFC eligibility criteria and use thoseVFC Eligibility criteria to screen children prior to administering VFC vaccines
Categories Notes
bull This form provides documentation needed for follow-up actions when you send your thank you email
The second to last page of the Provider Follow-up Plan has a summary of the MnVFC program recommendations These are to remind the site about best practices they may want to improve upon even though they are not yet requirements of the program For example you could discuss the recommendation about storage units if they currently have a combination household unit and are using both sections
The last section is for your signature and the person you met with In most sites it will be the immunization manager or vaccine coordinator who signs the form unless the medical director attended the site visit You keep the original copy and the site will need to keep a copy for themselves
To be completed by the site visit reviewer
I acknowledge that a VFC site visit was performed on __________________ (visit date) The follow-up plan which includes a list of all current VFC program requirements and recommendations assessed during the visit and any required follow-up actions was provided at the end of the visit
Site visit reviewer
Phone
Reviewer Signature Date
To be completed by the provider
I acknowledge that our practice took part in the VFC site visit noted above I understand the findings of the visit and any required actions that must be taken by our office in order to meet VFC program requirements
Medical Director (or designee) Name Title
Medical Director (or designee) Signature Date
IPI Advisor Manual | February 2017 Page 51
The 2017 MnVFC Site Visit Paperwork Chapter 4
After the Site Visit Send a thank you email highlighting the unmet requirements documents you need from the site to resolve the issue(s) and the date you need them Make sure to include the link to the Site Visit Survey (httpssurveyvovicicomseashxs=56206EE334CE0B14)
Please refer to Chapter 3 for more information about future follow-up required after the visit including forms and documentation
Resource bull Sample Thank You letter on IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml)
Chapter 5
IPI Advisor Resource List MnVFC Program 651-201-5522
MnVFC wwwhealthstatemnusvfc
bull Separate Stock and Replacement Method Policies and Procedures Manuals bull Online trainings bull MnVFC Announcements sign up to receive them via email bull Ordering MDH vaccine bull MnVFC forms Screening forms Reporting forms Others MDH Nonviable Vaccine Form MDH Vaccine Transfer Record and Vaccine Borrowing Report
bull MnVFC promotional materials bull Immunization Billing Guidance for MnVFC and Immunization Billing Guidance for MnVFC Replacement Sites Immunization Practices Improvement Program (IPI) wwwhealthstatemnusdivsidepcimmunizeipi
bull IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml) bull IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml) IPI Resource Folder Contents (wwwhealthstatemnusdivsidepcimmunizeipiipifolderpdf)
Minnesota Immunization Information Connection (MIIC) wwwhealthstatemnusmiic
bull MIIC regions and regional coordinators
Clinical Practice MDH Immunization Program wwwhealthstatemnusimmunize
Got Your Shots News wwwhealthstatemnusdivsidepcnewslettersgys
MDH Immunization Information for Health Care Providers wwwhealthstatemnusdivsidepcimmunizehcp
bull Got Your Shots A Providers Guide to Immunization in Minnesota bull Vaccine protocols bull Forms for tracking patient immunizations bull Immunization schedules for Health Care Providers Immunization Action Coalition (IAC) wwwimmunizeorg
bull Ask the Experts bull VISs (Vaccine Information Statements and translations) bull Administration screening questions bull Medical management of vaccine reactions bull Order form for Californiarsquos Immunization Technique DVD Best Practices with Infants Children and Adults
Page 52 IPI Advisor Manual| February 2017
IPI Advisor Resource List Chapter 5
CDC ldquoPink Bookrdquo wwwcdcgovvaccinespubspinkbookindexhtml
CDC Advisory Committee on Immunization Practices (ACIP) wwwcdcgovvaccinesacip
CDC Vaccines and Immunizations wwwcdcgovvaccines
VAERS reporting httpvaershhsgovindex
Storage and Handling Got Your Shots Providers Guide ndash Managing Vaccine wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml
MnVFC Guide to Temperature Monitoring Devices wwwhealthstatemnusvfc
MDH Clinicianrsquos Vaccine Mishap Checklist wwwhealthstatemnusdivsidepcimmunizeipivaxchklstpdf
MDH Vaccine Storage Guide wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml
CDC Vaccine Storage and Handling Toolkit wwwcdcgovvaccinesrecsstoragetoolkit
You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Vaccine manufacturer phone numbers wwwcdcgovvaccinespubspinkbookdownloadsappendicesFcontact-info-manufactpdf
IAC Checklist for Safe Vaccine Handling and Storage wwwimmunizeorgcatgdp3035pdf
IAC Donrsquot Be Guilty of These Errors in Vaccine Storage and Handling wwwimmunizeorgcatgdp3036pdf
Additional Resources Print materials from MDH ndash order forms wwwhealthstatemnusdivsidepcimmunizeordermathtml
Vaccine Education Center ndash Childrenrsquos Hospital of Philadelphia wwwchopeduservicevaccine-education-centerhomehtml
California Department of Public Health ndash Interactive training on vaccine administration and storage and handling handout on transporting vaccine and how to package wwwezizorg
IPI Advisor Manual | February 2017 Page 53
IPI Advisor Resource List Chapter 5
CDC vaccine price list wwwcdcgovvaccinesprogramsvfcawardeesvaccine-managementprice-listindexhtml
Vaccine Information Statements (VIS) wwwcdcgovvaccineshcpvisindexhtml
CEU Opportunities CDC Immunization Education and Training wwwcdcgovvaccinesedindexhtml
Immunization You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Page 54 IPI Advisor Manual| February 2017
- Introduction
-
- Welcome to the Immunization Practice Improvement (IPI) Program
- Contact Information
-
- Chapter 1
- Requirements to Participate in the MnVFC Program
- Vaccines for Children Program
- Chapter 2
- Reimbursement for MnVFC Visits
- Types of Visits
- Your MnVFC Clinical CoordinatorPlanner
- New IPI Advisor Training Requirements
- Your Role as an IPI Advisor
- Reasons MDH Would Do All or Part of a Visit
- Chapter 3
- Future follow-up
- Conducting the Visit
- Preparing for the Visit
- Information for the Visit
- Site Visit Checklist
- Scheduling the Visit
- Chapter 4
- After the Site Visit
- MnVFC Provider Follow-up Plan
- MnVFC Site Visit Storage and Handling Per Unit Answer Sheet
- Section 6 Inventory
- Section 5 Storage amp Handling Site-Wide
- Section 4 Storage amp Handling Per Unit
- Section 3 Documentation
- Section 2 Eligibility
- Section 1 Provider Details
- The Site Visit Reviewer Legend
- MnVFC Site Visit Questionnaire
- Required Paperwork for Site Visits
- Chapter 5
-
IPI Advisors Chapter 2
bull Complete the MnVFC site visit paperwork found on IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml)
bull Provide education about MnVFC program requirements and recommendations to site staff bull Ensure MnVFC program requirements are properly implemented and are being met bull Provide feedback and as necessary execute corrective action bull Follow-up on identified issues bull Notify your MnVFC clinical coordinatorplanner of issues that are not resolved by the due date
Follow-Up Visit
In-person follow-up visits will not be necessary for most MnVFC site visitsmdashonly those where significant issues are identified in the original visit If you are not able to complete part of the initial site visit because you found a storage and handling incident or you found multiple issues that need to be addressed a follow-up visit may be necessary Please contact the MnVFC clinical coordinatorplanner for approval and guidance for conducting a follow-up site visit
Educational Visit
Some sites may need more information and education than you can provide during a normal site visit This may be on topics related to immunizations immunization practices or administration or storage and handling issues These visits go beyond the sharing of pamphlets resources or information that is presented at a site visit Education visits should be conducted with a group and should focus on a topic that is identified during a site visit or requested by site staff Regularly scheduled meetings are not considered educational visits Educational visits need to be approved prior to the visit by the MnVFC clinical coordinatorplanner in order for you to receive reimbursement from the MnVFC program
Unscheduled (Unannounced) Storage amp Handling Visit
Unscheduled (unannounced) visits are not pre-scheduled with the site These visits require different paperwork and focus primarily on the storage and handling portion of a MnVFC site visit The MnVFC program is required to visit 5 percent to 10 percent of enrolled sites as unannounced visits each year Please discuss any unscheduled visits you would like to do with the MnVFC clinical coordinatorplanner You should plan to complete all of your regularly scheduled visits before doing any unscheduled visits
Enrollment Visit
All sites (including satellite clinics) that receive stock or supply MnVFC vaccine must have an enrollment visit that is conducted by MDH staff As an IPI advisor you may be asked to attend the enrollment visit This is an opportunity for you to start your relationship with the site and help with follow-up that may be necessary for the site to receive MnVFC vaccine Newly enrolled sites are scheduled for their first regular site visit within the first year (preferably within 3 to 6 months) and then every other year
IPI Advisor Manual | February 2017 Page 9
IPI Advisors Chapter 2
Reimbursement for MnVFC Visits Local public health agencies are paid for the site visits they conduct MDH will reimburse participating agencies only after we receive all of the required paperwork Paperwork submitted with incorrect or missing information may delay the reimbursement
IPI program reimbursement is processed on a quarterly basis and is processed in the month following each quarter through an electronic transfer of money Your agencycounty IPI advisor contact will receive an email notification of the reimbursement
Reimbursement rates are updated annually and available on the Contracts and Reimbursements (www healthstatemnusdivsidepcimmunizeipicontreimhtml) page
2017 MnVFC Site Visit Reimbursement Rates MnVFC Site Visit $400 Follow-up Visit$150 Education Visit$100 Unscheduled Visit$300
Reasons MDH Would Do All or Part of a Visit MDH may complete site visits or accompany you on a site visit if
bull The site is new to the MnVFC program (enrollment visit) bull The site has known issues or concerns regarding the MnVFC program especially if you are having difficulty resolving these issues
bull The site is refusing a site visit from local public health or yoursquore having a difficult time scheduling a visit
bull The site is part of tribal health or Indian Health Services bull MDH district epidemiologists will perform site visits at local health departments bull A new IPI advisor needs training from MDH staff bull Note MDH district epidemiologists will perform site visits at local health departments
Page 10 IPI Advisor Manual | February 2017
Chapter 3 Site Visits Scheduling the Visit
bull Check the information sheet or contact the site to confirm who the contact person is in charge of the MnVFC program In general this is the immunization manager or vaccine coordinator If the contact is no longer there ask for the person in charge of the sitersquos vaccines or the clinic manager They can usually direct you to the appropriate person You may want to follow a suggested phone script when contacting the site
Sample Phone Script for Scheduling a Visit
ldquoHello My name is _______ I am calling from ________ Health Department May I speak to (contact name) [If not available determine appropriate person to talk to or a better time to call back] I am calling to schedule a MnVFC site visit This visit will involve a review of immunization practices at your site We will look at vaccine administration storage and handling screening for eligibility and documentation of vaccinations It usually takes about two hours for a visit depending on the number of vaccine storage units you have Is there a day or time of day that works best for you
I have a pre-visit worksheet to send to you to help you prepare for the visit It contains information about what I will need at the visit such as temperature logs and immunization documentation information Completing this worksheet prior to me arriving will help the visit be more efficient Is there any other information that I can send to help you prepare for the visit
If you have any questions call me at ________ Thank you for your time and assistance I look forward to working with yourdquo
bull Arrange a date and time for the visit bull Let them know an approximate visit length Visits are usually around two hours long depending on the size of the site the number of vaccine storage units they have or if they have new staff
bull Request that key staff be present at the visit This could include the immunization manager vaccine coordinator immunization staff clinic manager nurse manager billing staff andor medical director
bull Inform your site contact that you will be sending them an email confirmation along with the MnVFC
Pre-Visit Worksheet
Site Visit Checklist Use the Site Visit Checklist on IPI Advisor Site Visit Materials (wwwhealthstatemnusdivs idepcimmunizeipisvmaterialshtml) to make sure all necessary steps are covered
MINNESOTA VA C CI N ES FO R CHI LD REN PROGRAM
Site Visit Checklist Date of visit Time
Site Name PIN
Address
Contact Phone
Complete Before the visit Comments
Review the clinic list Identify and prioritize which sites you will visit
Email or call to schedule a date and time for the visit Ask for the immunization manager or vaccine coordinator
Email appointment confirmation attach Pre-visit Worksheet and provide instructions for returning it prior to the visit (sample email on website) Include length of the visit and which staff should be present
Add site visit to Outlook calendar and reserve a car (if needed)
Review temp logs and Pre-visit Worksheet
Send a reminder email 2-3 days ahead of the visit
IPI Advisor Manual | February 2017 Page 11
i i li
Site Visits Chapter 3
Information for the Visit2017 MnVFC Pre-Visit Worksheet Site name MnVFC PIN
Address
Medical director Email
Immunization manager Phone
Vaccine coordinator Phone
Vaccine coordinator back-up Email
IPI Site Vis t Preparat on Check st
The staff listed have completed the MnVFC online training and printed a certification of completion Immunization Manager Vaccine coordinator Vaccine coordinator back-up
Have a copy of the most recent provider agreement
Check if the above listed staff have changed since the provider agreement was completed
Check all of the vaccines administered at your site and list the corresponding publication date for each VIS you give to patients
DTaP _____________ Hepatitis A _____________ Hepatitis B _____________ Hib _____________ HPV _____________
Influenza _____________ MCV4 _____________ MMR _____________ MMR-V _____________ PCV13 _____________
Polio _____________ Rotavirus _____________ Tdap _____________ Varicella _____________
Non-Routine Vaccines Men B__________ PPSV23 _____________ Td _____________
Vaccine administration fee charged for MnVFC eligible children is $
Have a Vaccine Management and Emergency Plan that has been reviewed and dated within the last year
Have the borrowing reports if applicable for the last 12 months available at the visit
Have an anaphylaxis protocol that is clearly posted and reviewed annually
Send an appointment reminder email and the MnVFC Pre-Visit Worksheet to the MnVFC contact A sample letter and the MnVFC Pre-Visit Worksheet can be found on the IPI Advisor Site Visit Materials (wwwhealthstate mnusdivsidepcimmunizeipisvmaterialshtml) page You can request that the MnVFC Pre-Visit Worksheet and temperature logs be sent to you prior to the visit for your review
Contact the site by phone or email one or two working days before the scheduled visit to confirm your appointment This is also a good time to ask for directions and parking information if you are not familiar with the site
Preparing for the Visit Review the site visit paperwork to familiarize yourself with the questions For most of the questions there is a ldquoNote to the reviewerrdquo These notes give helpful tips about the information you are looking for when asking this question It contains the rationale for the question and which resources to provide to the site to support the rationale Some sections also require immediate on-site actionsmdashthings you must do while you are at the site and some require future follow up
bull Print copies the of site visit paperwork bull Site visit forms are available on the IPI Advisor Site Visit Materials (wwwhealthstatemnusdivs idepcimmunizeipisvmaterialshtml) page 2017 MnVFC Site Visit Questionnaire 2017 MnVFC Site Visit Storage amp Handling per Unit Answer Sheet (print one for each stand-alone andor combination storage unit at the site) 2017 MnVFC Provider Follow-up Plan (print two copies)
bull Review any previous site visit paperwork that is available You should check in with MDH staff after your visits if the site continues to have the same issues as past visits
bull Also be sure to bring Your thermometers If the sitersquos certificate of calibration is expired or the probe is not properly placed place your thermometer in the storage unit when you arrive and read the temperature just prior to reviewing the site visit findings
The MnVFC folder with additional immunization resources you wish to add (see chapter 5) and the Vaccine Storage amp Handling magnet (to order email healthIPIinquiriesstatemnus) A copy of the appropriate MnVFC Policies and Procedures Manual found on the MnVFC website (wwwhealthstatemnusvfc) Appropriate temperature logs (Celsius or Fahrenheit) Site information sheet that contains the quantity and value of the vaccine distributed to the sitesystem
Page 12 IPI Advisor Manual | February 2017
Site Visits Chapter 3
Conducting the Visit Education is a large part of the MnVFC site visit Often approaching this visit as an exchange of information with the site is more successful than a ldquoregulatoryrdquo visit Putting the staff at ease answering their questions and making a plan to address issues that arise during the visit is more helpful than a ldquopassfailrdquo attitude Education will usually consist of providing the rationale for the requirement referring to the requirement in the MnVFC Policies and Procedures Manual and providing resources to help address the situation Some questions will require additional follow-up to assure the site has corrected the issue(s) and is meeting the MnVFC requirement(s) This will be addressed further in the follow-up section
Completing the Paperwork
There are three documents that you must complete for the MnVFC site visit bull 2017 MnVFC Site Visit Questionnaire bull 2017 MnVFC Site Visit Storage amp Handling per Unit Answer Sheet (one for each storage unit) bull 2017 MnVFC Provider Follow-up Plan (two copies or you may ask them to make you a copy of the completed form for their records)
Answer the questions on the MnVFC Site Visit Questionnaire based on how things are when you arrive at the site If they correct the issue during the visit you will still mark it as an unmet requirement and document how it was addressed during the visit
The ldquoAnswerrdquo field will contain all the possible answer choices for this question For most questions answer choices will be followed by the markings below
bull Answer choices with no marking mean the site meets the CDC requirement bull Answer choices marked with an [X] indicate that this specific answer choice is non-compliant with a CDC requirement
bull Answer choices marked with an [O] indicate that this specific answer choice is not aligned with a CDC recommendation
If you marked the box with the [X] which is non-compliant with the CDC requirement conduct a root cause analysis to determine the reason for non-compliance Root cause analysis is an important component to a successful site visit It is used to identify the cause of the problem and help to resolve the issue There are several possible root causes that can be identified Choose only one root cause
bull Human cause Personal beliefsopinions Does not understand rationale of requirement Lack of concern for compliance
bull Organizational cause Competing job assignmentsworkload Lack of (insufficient) staff to perform required duties Budget limitations (for required equipment) Lack of (insufficient) training of staff Lack of (insufficient) processesprotocols
IPI Advisor Manual | February 2017 Page 13
Site Visits Chapter 3
Once identified the root cause should be documented in the questionnaire including a brief explanation of why you chose that cause This allows for follow-up with the site and a way to help find improvements to meet the unmet requirement Complete any immediate on-site action These often require providing education and resources for the site Mark the box for each action taken If you provide additional resources or information you can use the notes section to indicate the additional items
ldquoFuture follow-uprdquo are actions the site needs to take to meet the requirements of the program Wersquoll go over more specific information about the site visit questionnaire in Chapter 4
Performing the Site Visit
As you become familiar with the MnVFC program and develop a relationship with your sites you will develop a visit pattern that works for you Here is one possible sequence for conducting MnVFC site visits
bull When you arrive at the site if you have a business card it is helpful to provide it to the front desk staff person
bull When you meet with the immunization manager andor vaccine coordinator introduce yourself and explain the expectations for the visit
bull Ask to see the temperature monitoring device(s) It must have a current certificate of calibration and the probe must be properly placed in the unit If it does not meet the requirements place your thermometer in the unit at the beginning of the visit so that it has sufficient time to reach an accurate temperature by the time you complete your assessment of the storage units
bull 2017 MnVFC Site Visit Questionnaire Ask all of the questions You may have to modify the order of the questions based on what is best for the site When you get to the storage and handling section (section 4) use the answer sheet(s) to document the answers to the questions for each storage unit that stores vaccine (MnVFC or private) Do not write answers in the questionnaire unless there is an unmet requirement Be sure to ask if there is vaccine stored anywhere else at any time at this location This includes a co-located pharmacy If so these additional units will need to be assessed as well If the site has a combination refrigeratorfreezer household unit and is using both sections discuss with them the recommendation (and probable future requirement) to have a separate freezer Refer to MDH if they have further questions or need more information Be prepared to address any storage and handling mishaps that you may find A copy of the
Clinicianrsquos Vaccine Mishap Checklist is with your visit materials and the Emergency Response Worksheet is in the MnVFC Policy and Procedure Manual If you are unsure how to handle the problem call the MnVFC program at 651-201-5522 during or after the visit
Page 14 IPI Advisor Manual | February 2017
Site Visits Chapter 3
Ending the Visit bull Fill out the two copies of the 2017 MnVFC Provider Follow-up Plan (or ask them to make a copy once it is completed for their records) Indicate if they have not met the requirement by checking the box in the ldquoUnmetrdquo column If they are not meeting requirements check the required actions Review the plan with them reinforcing the positive things they are doing as well as reviewing the required follow-up action(s) Give the site a copy of the Provider Follow-up Plan Keep the signed copy of the Provider Follow-up Plan to submit with your paperwork Do not leave a copy of the Site Visit Questionnaire at the site
bull Let them know you will be sending a thank you email that will summarize the site visit Included in the email will be a survey link you would appreciate them completing regarding the visit
After the Visit bull Send the site a thank you email There is a template thank you letter on the IPI Advisor Site Visit Materials (wwwhealthstate mnusdivsidepcimmunizeipisvmaterialshtml) page Be sure you include the issues that you identified and the timeline for their completion as well as the good things you found at the visit In the template letter be sure to include the survey link The survey is very brief ndash a few questions and space to write comments
bull Either transfer your MnVFC Site Visit Questionnaire and MnVFC Site Visit Storage amp Handling per Unit Answer Sheet information to the fillable version or submit the handwritten form to MDH
Documentation of the Visit
Paperwork must be submitted to MDH within 10 days of the visit in order to meet the federal VFC programrsquos reporting requirements Do not wait to complete your follow-up before submitting the site visit paperwork
Send the following documents to MDH bull 2017 MnVFC Site Visit Questionnaire (includes the cover sheet) bull 2017 MnVFC Site Visit Storage amp Handling per Unit Answer Sheet (one for each unit) bull 2017 MnVFC Provider Follow-up Plan (original signed plan)
Submit site visit materials to bull Email healthIPIinquiriesstatemnus (preferred) bull Mail IPI Program Specialist
Immunization Practices Improvement Program Minnesota Department of HealthPO Box 64975St Paul MN 55164-0975
IPI Advisor Manual | February 2017 Page 15
Site Visits Chapter 3
Future follow-up Follow-up is an important component of the site visit It helps us ensure that the unmet requirements have been corrected The questionnaire has different time periods for follow-up depending on the question Do not wait to complete your follow-up before submitting the site visit paperwork
When you complete the Follow-Up Form make sure to keep a copy for yourself MDH also keeps track of follow-up required and will remind you if follow-up has not been completed by the deadline Most follow-up can be done with a phone call or email In-person follow-up is rarely required and should be discussed with MDH before scheduling a follow-up visit
All requirements that need follow-up are identified with a [X] on the site visit paperwork and are listed on the MnVFC Provider Follow-up Plan
bull Follow-up with the site to see how they have resolved the unmet requirements bull Document your follow-up on the Follow-Up Form available on the IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml) page If follow-up was done via letter or email a copy can be attached to the Follow-Up Form
bull Send your Follow-Up Form to MDH (healthIPIinquiriesstatemnus) with supporting documents and emails
bull If a site is not responding to your requests regarding follow-up contact your MnVFC clinical coordinatorplanner They can help with additional follow-up as needed
Page 16 IPI Advisor Manual | February 2017
Chapter 4 The 2017 MnVFC Site Visit Paperwork This chapter will go through the required MnVFC site visit paperwork with notes about information or resources to help the site address questions or issues that may arise during the visit
The MnVFC site visit paperwork is available on the IPI Advisor Site Visit Materials (wwwhealthstate mnusdivsidepcimmunizeipisvmaterialshtml) page
Please download the paperwork shortly before your visit as there may be updates and changes and this will be the most up-to-date version of the questionnaire We will send out a Workspace message with major changes
Required Paperwork for Site Visits bull 2017 MnVFC Site Visit Questionnaire bull 2017 MnVFC Storage amp Handling Per Unit Answer Sheet ndash one for each unit assessed during site
visit bull 2017 MnVFC Provider Follow-up Plan ndash with provider signature
Make sure to include the sitersquos PIN on all your paperwork Please complete and submit your site visit paperwork as soon as possible after your visit It may be helpful to schedule some time into your calendar to complete your paperwork in the days following your visit Once you have completed the post-visit follow-up send in the Follow-Up Form with documentation of the follow-up actions Please do not wait until you have completed your follow-up before sending in your initial paperwork
MnVFC Site Visit Questionnaire The questionnaire includes these six sections 1 Provider details 2 Eligibility 3 Documentation 4 Storage amp handling per unit 5 Storage amp handling site-wide 6 Inventory
IPI Advisor Manual | February 2017 Page 17
Page 18 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
The Site Visit Reviewer Legend The legend explains the formatting of the 2017 questionnaire This includes information that will be helpful in completing the site visit
Site Visit Reviewer Guide Legend
Section Number Content Area
Question number This area will always contain the text of the question
Note to reviewer The note to reviewer contains information that is necessary for properly asking and assessing responses tothe question above This may include definitions of terms requirement details and other helpful tips
Answers This field will contain all the possible answer choices for this question For most questions answer choiceswill be followed by the markings below
Answer choices marked with an [X] indicate that this specific answer choice is non-compliant with a CDC requirement Answer choices marked with an [O] indicate that this specific answer choice is not aligned with a CDC
recommendation
Review CDC RequirementRecommendation
This field will be populated with the CDC requirementrecommendation associated with the given question
Actions if Non-Compliant
Root Cause Analysis As part of the site visit reviewers are required to assess and understand the reasons why a provider office isnon-compliant with VFC program requirements ndash this is a root cause analysis Reviewers must choose theone root cause that they believe most contributes to the non-compliance Upon establishing the root causethe reviewer must provide a clear explanation of hisher findings
Immediate Action These are actions that CDC requires reviewers to take on site during the visit
Future Follow-up These are future follow-up actions (with designated due dates) that are required of the reviewer andorprovider to remedy non-compliance Reviewers must complete all follow-up in accordance with CDCestablished deadlines
Notes Information you want the VFC program to be aware of or that explains your answer in detail
bull Note to reviewer These are notes to help you understand what the question is asking for and to clarify things you might want to know when asking or rephrasing the question
bull Answers This section helps you to know when the answer does not meet the CDC requirement [X] or recommendation [O] Whenever an answer with a [X] is checked the ldquoActions if Non-compliant section must be completed The recommendations are usually good teaching points about best practices andor future requirements of the VFC program
bull Review the CDC RequirementRecommendation This section provides a specific outline of the requirement or recommendation to give you information to use in talking with the site staff
bull Actions if Non-Compliant This section describes what to do if the site is not meeting a requirement Root cause analysis This section asks you to probe beyond the surface to find what is driving the non-compliance It is intended to help uncover reasons for recurring non-compliance issues identify additional training needs and inform reviewer follow-up actions Select only one root cause and explain the particular circumstances in the space ldquoExplanation of root causerdquo line provided If there appear to be multiple issues choose the one that most contributes to the non-compliance and describe all factors in the explanation Immediate actions A list of actions to take during the site visit to address the issue Future follow-up A list of actions to take after the site visit by the set deadline
bull Notes This section can be used for notes to yourself or to MDH
IPI Advisor Manual | February 2017 Page 19
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 1 Provider Details Questionnaire Coversheet
The first page of the questionnaire collects the demographic information for the site You can use this page to help prepare for the visit Most of the demographic information about the site should be on the site-specific document you received with your clinic list You will validate that this information is current at the time of the site visit It also helps to know if this is a separate stock site or a replacement site before the visit so you can bring a copy of the appropriate MnVFC Policies and Procedure Manual
2017 MnVFC Site Visit Questionnaire Date of visit _____________ Date forms sent to MDH ______________
Site Information
Site name MnVFC PIN
Address Separate Stock Replacement
City ZIP County
Medical Director Email
Immunization Manager Phone
Vaccine Coordinator Phone
Vaccine Coordinator back-up Email
Point of contact Phone
Personnel at site visit
On this page bull The date of the visit and the date when you send these forms to MDH This information helps us track the timeliness of our review and data entry process
bull The vaccine management method used by the site (replacement or separate stock) bull The name and email of the medical director (ideally this is the person who signed the MnVFC
Program Provider Agreement)bull Contact information for the immunization manager vaccine coordinator vaccine coordinator back-up and point-of-contact for this visit The immunization manager vaccine coordinator vaccine coordinator back-up roles are
described in the MnVFC Policies and Procedure Manual The vaccine coordinator back-up may be the immunization manager or another staff person depending on the size of the site and available personnel The Point of Contact is the person you set up the appointment with signs the Provider Follow-
up Plan and receives the follow-up email This may be one of the people listed above
The Post Visit Steps section is a reminder to you about what needs to done after the visit The Education on Immunization Best Practices for Sites section reminds you to provide the resource folder to the site
Page 20 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 12
1 Provider Details Changes to Key Staff
Question 12 Ask the provider about changes to key staff to answer the questions below
A (Choose all that
apply)
At the time of the visit is the Medical Director the same individual that signed the ProviderAgreement and are the Immunization Manager and Vaccine Coordinator the same asthose last reported to the program
Yes No the Medical Director has changed No the Immunization Manager has changed No the Vaccine Coordinator has changed
B (Choose one)
Were all changes communicated to theImmunization Program according to yourprogramrsquos policy
Yes or no staff changes No [X]
C (Choose one)
Based on review of the trainingdocumentation have the current Immunization Manager Vaccine Coordinator and back-up completed all required training
Yes No [X]
Review CDC Requirement
All changes in key staff must be communicated to the Immunization Program in the manner and timeframe defined by theImmunization Program Key staff include the Medical Director or equivalent who signed the Provider Agreement the Immunization Manager Vaccine Coordinator and the back-up VFC providers are required to ensure that all key staff are fully trained on VFC program requirements at all times All training must be documented
Goal of this question Determine if there are new staff in key positions at the site and to make sure staff are properly educated about the MnVFC program A This information can help you determine the level of knowledge and experience the staff have with the MnVFC program Follow-up throughout the visit can be tailored for various levels of staff experience Likewise you may identify additional training needs for new staff
B When sites notify us of changes in key personnel we update their information in MIIC and on the clinic lists We also send the new staff information for completing the online training and direct them to read the appropriate MnVFC Policies and Procedures Manual If the answer to this part is no update the demographic area of the questionnaire and inform the staff that in the future they must notify the MnVFC program (via email or phone) if the immunization manager or vaccine coordinator changes Resource Section 12 of the MnVFC Policies and Procedures Manual
C Annual training must be verified by looking at the certificates for the online training If the answer to this part is no refer the staff to complete the appropriate MnVFC online training found on the MnVFC website (wwwhealthstatemnusvfc) for their program (separate stockreplacement) for the current year and send you a copy of the certificate within 30 days
Resource bull Sections 12 and 14 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 21
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 2 Eligibility Question 21
Goal of this Question Assess whether staff correctly understand which patients are eligible for the MnVFC program Screening ensures that eligible children receive the vaccines that they are entitled to receive under the MnVFC program and helps to prevent fraud or abuse of the program
Children 18 years and younger in these
categories can receive MnVFC vaccine at any enrolled site bull Uninsured bull Enrolled in a Minnesota Health Care Program (MHCP) Medical Assistance (MA) or MinnesotaCare bull American Indian or Alaskan Native
The following categories are considered underinsured and are only MnVFC-eligible at local public health (LPH) Federally Qualified Health Centers (FQHC) Rural Health Centers (RHC) Indian Health Services (IHS) and tribal health clinics
bull Has health insurance that does not cover one or more vaccines as can be the case with newly licensed vaccines that arenrsquot yet covered (MnVFC-eligible for non-covered vaccines only)
bull Has health insurance that caps vaccine coverage at a certain amount Once that amount is reached the child is MnVFC-eligible
Children with insurance that does not cover vaccines until a deductible has been met are considered to be fully insured and are not MnVFC-eligible
Helpful information bull Sites are not required to verify the patientrsquos response to the screening questions For example if a patient states they lost their insurance the site does not need to call the patientrsquos insurance company to confirm
If the site cannot correctly describe the eligibility categories provide educational materialsresources on MnVFC eligibility requirements
Resources bull Patient Eligibility Screening Record on MnVFC Forms (wwwhealthstatemnusdivsidepc immunizemnvfcformshtml)
bull Section 1 of the MnVFC Policies and Procedures Manual
2 Eligibility VFC Eligibility Categories
Question 21 Was the individual responsible for determining patient VFC eligibility able to explain all the factors(including age) that make a child eligible to receive VFC vaccines
A Patient is less than 19 years of age Yes No [X]
B Patient is Medicaid-eligible Yes No [X]
C Patient is uninsured Yes No [X]
D Patient is underinsured Yes No [X]
E Patient is American Indian Yes No [X]
F Patient is Alaska Native Yes No [X]
Review CDC Requirement
VFC providers must possess a working knowledge of all VFC eligibility criteria and use those criteria to screen children prior toadministering VFC vaccines In order to receive VFC vaccine a patient must be under the age of 19 and must be at least one of the following (1) Medicaid-eligible (2) Uninsured (ie child has no health insurance) (3) Underinsured (ie child has health insurancebut coverage does not cover any or certain vaccines ndash underinsured children may only receive VFC vaccines in FQHCRHC ordeputized VFC provider offices and only for vaccines not covered by insurance) and (4) American Indian or Alaska Native (AIAN)
Page 22 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 22
2 Eligibility Billing Practices
Question 22 Is the individualdepartment responsible for billing able to clearly explain how they bill for both the costof vaccine and the vaccine administration fee for each of the eligibility categories below
A Medicaid-eligible Cost of Vaccine Do not bill ndash provided by VFC Admin Fee Bill Medicaid
Yes No [X]
B Uninsured Cost of Vaccine Do not bill ndash provided by VFC Admin Fee If billing can bill patient
Yes No [X]
C Underinsured Cost of Vaccine Do not bill ndash provided by VFC through FQHCsRHCs or deputized providers only all other providers cannotprovide VFC vaccine to underinsured patients Admin Fee If billing can bill patient
Yes No [X]
D American IndianAlaska Native(AIAN)
Cost of Vaccine Do not bill - provided by VFC unless patient is fully insured and parent chooses to use insurance Admin Fee If patient is Medicaid-eligible bill Medicaid if billingand patient is uninsuredunderinsured can bill patient if parentchooses to use private insurance for cost of vaccine billpatientinsurance
Yes No [X]
E Do individuals responsible for billing have access to the results of eligibility screening toensure proper billing
Yes No [X]
Review CDC Requirement
VFC providers must adhere to proper billing practices for vaccine administration fees and clearly understand that VFC vaccine isprovided at no cost to both the VFC provider and eligible children At no time should billing occur for the cost of VFC vaccine Whenadministering VFC vaccine providers should never bill two different ldquopayersrdquo (ie patient Medicaid insurance) for the samevaccine administration fee amount For Medicaid-eligible children Medicaid should be billed for the vaccine administration fee Forall other VFC-eligible populations the patient may be billed within the stateterritory cap established by the Centers for Medicareand Medicaid (CMS) However patients cannot be turned away or reported to collections for inability to pay the administration fee
Goal of this question Determine if the staff correctly understand how to bill patients that are eligible for the MnVFC program Billing appropriately ensures that children can receive low cost immunizations and the site is in compliance with the VFC program
bull If there is any indication that sites could be billing insurance companies or parents for VFC vaccines this should be investigated further
bull Most sites in Minnesota will bill Medicaid with the SL modifier ndash which indicates this is a Medicaid claim
bull The main point is to ensure the site is not billing uninsured children for VFC vaccine and are not charging them more than $2122 per vaccine for the administration fee
bull Non-compliance is usually unintentional and may be resolved with some training In rare cases it could be a glimpse into a larger problem where a site is intentionally billing for financial gain
bull If you think the site is billing inappropriately it is the responsibility of the IPI advisor to report concerns to MDH staff for further assistance
Resources bull Immunization Billing Guidance for MnVFC (wwwhealthstatemnusdivsidepcimmunizemnvfc billingtipshtml) or Immunization Billing Guidance for MnVFC Replacement Method Sites (www healthstatemnusdivsidepcimmunizemnvfcreplacementbillingtipsrephtml)
bull Section 2 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 23
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 232 Eligibility Vaccine Administration Fee
Question 23 Document the actual vaccine administration fee charged to non-Medicaid VFC-eligible patients (confirmwith billing department)
Answers Fee $ [X] Follow-up is required if the provider charges more than the fee cap establishedby the Centers for Medicare and Medicaid (CMS) for your stateterritory ($2122)
Review CDC Requirement
The VFC providerrsquos vaccine administration fee for non-Medicaid VFC-eligible children must not exceed the stateterritory vaccineadministration fee cap established by the Centers for Medicare and Medicaid (CMS) For current fee caps refer to Medicaid Program Payments for Services Furnished by Certain Primary Care Physicians and Charges for Vaccine Administration Under theVaccines for Children Program Final Rule (httpwwwgpogovfdsyspkgFR-2012-11-06pdf2012-26507pdf)
Goal of this question Ensure that sites are not charging more than the federal allowable vaccine administration fee of $2122
bull The Centers for Medicaid and Medicare (CMS) establishes a maximum fee that sites can charge to non-Medicaid-eligible VFC patients in each stateterritory for vaccine administration Health Plans usually negotiate this fee with the site but Medicaid will not pay more
bull If a parent cannot pay the vaccine administration fee the patient cannot be turned away or reported to collections VFC-eligible children must be vaccinated regardless of their ability to pay
bull If the person with whom you are conducting the site visit does not know the exact fee charged to non-Medicaid VFC-eligible patients ask to speak to someone who can verify the exact amount
bull If they are charging more than $2122 for the administration fee ndash please contact MDH staff for help with addressing this situation
Resources bull Immunization Billing Guidance for MnVFC (wwwhealthstatemnusdivsidepcimmunizemnvfc billingtipshtml) or Immunization Billing Guidance for MnVFC Replacement Method Sites (www healthstatemnusdivsidepcimmunizemnvfcreplacementbillingtipsrephtml)
bull Section 2 of the MnVFC Policies and Procedures Manual
Page 24 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 3 Documentation Question 31
3 Documentation Eligibility Screening amp Documentation
Question 31 To answer the questions below the provider must clearly demonstrate the patient intake processReview a minimum of 10 records that contain an immunization visit within the last 6 ndash 12 months
Note to Reviewer Criteria for Record Selection 1) Record selection must be completely random and the provider must not know prior to the visit which
records will be reviewed 2) Patient must have been 0-19 years of age at the last visit (Note Records of 19-year-old patients may
allow you to see if VFC vaccines are being used beyond the allowable age) 3) Must review a mix of public and private-pay patients (if applicable)
A Does the provider have a process that ensures that patients are screened forVFC eligibility at each visit and that screening results are documented at each visit
Yes No [X] (If no skip question F)
B Does the providerrsquos process ensure that staff administering vaccine know which vaccine stock to select from prior to drawing the vaccine
Yes No [X]
C Number of records reviewed If fewer than 10 records are reviewed select the reason why Provider does not have 10 patient records with immunizations in last 12 months
D Do all records contain date of the immunization visit and patientrsquos date of birth Yes No [X]
E Do all records contain the patientrsquos specific eligibility status associated with thedate of the immunization
Yes No [X]
F Do any of the providerrsquos records contain any evidence that the patient received vaccine for which they were not eligible
Yes [X] No
Review CDC Requirement
VFC providers must screen for and document VFC eligibility at each immunization visit Documentation must include the date of the visit and the childrsquos specific eligibility category VFC providers must use screening results to ensure that only VFC-eligible children receive VFC vaccine and that administration fees are billed for as appropriate Eligibility status must be readily available to staff administering vaccine prior to selecting which vaccine stock to use
Goal of this question Ensure the site is screening for eligibility and documenting the eligibility category in the medical record
Review a minimum of 10 records from within the last 6-12 months where the patient received an immunization You must review a mix of public and private pay patients (if applicable)
Random selection is important If the staff have pre-selected records for review do not use and identify additional randomly selected records to review
Helpful information bull Discuss upgrading the electronic health record to make documentation of VFC eligibility screening a required field Documenting eligibility screening in the immunization field promotes better MIIC data
bull Q 31 B Sites using the replacement method of vaccine management only have one stock so you will answer ldquoYesrdquo to this question
Resources bull Patient Eligibility Screening Record on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfcformshtml)
bull Section 1 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 25
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 32
3 Documentation Vaccine Dose Documentation
Question 32 Review a minimum of 10 patient immunization records from the last six months (or 12 months ifnecessary) to assess compliance with documentation requirements set forth by Statute 42 US Code 300aa-25 (See note to reviewer below)
Note to Reviewer Criteria for Record Selection 1) Record selection must be completely random the Provider must not know prior to the visit which records
will be reviewed 2) Patient must have been 0-19 years of age at the last visit (Note Records of 19-year-old patients may allow
you to see if VFC vaccines are being used beyond the allowable age)
Records are Compliant if they Contain ALL the Below Elements
bull Address of clinic where vaccine was administered bull Publication date of VIS bull Name of vaccine administered bull Name of vaccine manufacturer bull Date vaccine was administered bull Lot number bull Date VIS was given bull Name and title of person who administered the
vaccine
A Number of records reviewed
B Number of records that contain ALL required documentation elements
If fewer than 10 records are reviewed select the reason why Provider does not have 10 patient records with immunizations in last 12 months
[X] Follow-up isrequired if one ormore records do not meet requirements
Goal of this question Assess whether the site is documenting all required information in each patientrsquos medical record for every vaccine dose administered in accordance with the National Childhood Vaccine Injury Act
Resources bull Section 6 of the MnVFC Policies and Procedures Manual bull National Vaccine Injury Compensation Program (wwwhrsagovvaccinecompensation)
Question 33
3 Documentation Record Retention
Question 33 Is the provider able to demonstrate (preferred) or clearly describe how they maintain historical VFCeligibility documentation for three years
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers are required to maintain all records related to the VFC program for a minimum of three years (or longer if requiredby state law) and upon request make these records available for review VFC records include but are not limited to VFC screening and eligibility documentation billing records medical records that verify receipt of vaccine vaccine ordering records and vaccinepurchase and accountability records
Goal of this question Make sure the site understands they are required to keep all MnVFC screening documentation for at least three years either electronically or on paper This information should be available to you at the time of the visit and future visits
Resource bull Section 7 of the MnVFC Policies and Procedures Manual
Page 26 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 34
3 Documentation Borrowing Documentation
Question 34 Discuss borrowing practices with the provider to answer the questions below
Note to Reviewer bull To be considered ldquofully documentedrdquo documentation for each borrowed dose must include thefollowing information
Vaccine type borrowed Date the dose was administered Stock used (VFC or private) Reason appropriate vaccine stock was not used Patient name and date of birth Date dose was returned to appropriate stock
A Did the provider state that they had borrowed any vaccines (whetherdocumented or not) since the last VFC Compliance Site Visit
Yes No (If no skip to question 36)
B Are there any doses for which there is no documentation (ie provider hasindicated that doses were borrowed but cannot verify how many or why)
All doses are documented Some doses are not documented [X] No doses are documented [X] (if nodoses documented skip toquestion 36)
C Were all borrowed doses fully documented (See Note to Reviewer above) Yes No [X]
D Were all borrowed VFC doses either replaced or an order submitted to replacethe doses Yes No [X]
Review CDC Requirement
VFC providers are expected to maintain an adequate inventory of vaccine for VFC and non-VFC-eligible patients It is theresponsibility of the VFC provider to appropriately schedule and place vaccine orders VFC providers must also rotate stock to ensure timely use of short-dated vaccines Borrowing of vaccine between private and public inventories must be a rare unplanned occurrence and cannot serve as a replacement system for a VFC providerrsquos privately purchased vaccine inventory All instances ofborrowing must be properly documented reported and replaced
Goal of this question Assess vaccine accountability by verifying that children are receiving vaccine from the appropriate stock
Borrowing is when a fully insured child receives a dose of MnVFC vaccine or a MnVFC-eligible child receives a dose of private vaccine This should be a rare unplanned occurrence The site must document any borrowing of vaccine between stocks ideally on the VFC Borrowing Report Form If they are not currently using the form review it with them and encourage them to post it close to their vaccines It does not need to be sent to MDH but should be kept for 3 years and filed with their MnVFC documents to be reviewed whenever they have a regular or unscheduled (unannounced) site visit
Helpful information bull Understand and report on staffrsquos verbal (ie anecdotal) accounts of borrowing obtained during the visit Often sites do not know that what they do is considered borrowing or they think borrowing is acceptable and documentation isnrsquot needed so long as those vaccines are eventually replaced
bull Since sites using the replacement method only have one stock of vaccine they very rarely borrow bull This question asks for future follow-up in 6 months Make a note on your calendar and ask them to send you a copy of their borrowing reports for the previous 6 months with documentation of doses borrowed and replaced We will remind you if we donrsquot hear from you at the 6 month time frame Complete the Follow-up Form and attach the borrowing form
Resources bull Vaccine Borrowing Report on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfc formshtml)
bull Section 10 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 27
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 353 Documentation Borrowing Reasons
Question 35 Based on your discussion with the provider and a review of borrowing reports document the dosesborrowed for each reason and answer the questions below
Note to Reviewer bull Short-dated vaccines are doses that are likely to expire before they can be used bull Exchanging short-dated vaccines should only occur in practices that have a small number of private
patients
A Reasons for Borrowing a VFC Dose (Enter the number of _____ Private vaccine shipment delay (order placed on time but delay in shippingreceipt)
vaccine doses borrowed for each
reason in the spaces
_____ Private vaccine not useable on arrival (vials broken temperature monitor out of range) _____ Ran out of private vaccine between orders (provider orders not placed on time) [X]
provided) _____ Short-dated private dose was exchanged with VFC stock _____ Accidental use of VFC dose for a private patient (human error) _____ Replacement of private dose with VFC when insurance plan did not cover vaccine _____ OtherDocumented dose did not include reason for borrowing [X]
(Explanation Required) Reasons for Borrowing a Private Dose _____ VFC vaccine shipment delay (order placed on time but delay in shippingreceipt) _____ VFC vaccine not useable on arrival (vials broken temperature monitor out of range) _____ Ran out of VFC stock between orders (provider orders not placed on time) [X] _____ Short-dated VFC vaccine dose was exchanged with private dose _____ Accidental use of a private dose for a VFC-eligible patient (human error) _____ OtherDocumented dose did not include reason for borrowing [X]
(Explanation Required)
B Enter date range for instances of borrowing reviewed in the borrowing report Note If ldquoDate of earliest instancerdquo is not available use the date of the last VFC Compliance Visit If ldquoDate of last instancerdquo is not available use the date of thecurrent VFC Compliance Visit
Date of earliest instance
Date of last instance
C Does borrowing appear to be a routine practice Note To determine whether borrowing is a routine practice assess frequency of and repeating reasons for borrowing Examples Frequent accidental use of incorrect stock exchanging short-dated vaccines or issues with ordering and shipment
Yes [X] No
Goal of this question Determine the reasons why the site is borrowing vaccine
If sites are using the Vaccine Borrowing Report review the reasons for borrowing to help document borrowed VFC andor private doses If they have not been documenting borrowing on this report (or any other form) estimate their borrowing practices If you do not know the date range for their borrowing use the last site visit date to the current visit date The use of ldquootherrdquo as the reported reason for borrowing should be rare if ever and would require explanation and follow up
Helpful information bull Look to see if they routinely maintain insufficient amounts or types of vaccine to support their public and private patients that leads to borrowing
bull Pay attention to borrowing cases documented as ldquoaccidentalrdquo Repetitive accidental borrowing may indicate an issue with ordering processes or insufficient staff training
bull Borrowing is not a place to document wasted or lost doses bull The time period of the borrowing may give you clues about the root cause Were the borrowed doses concentrated in a short period or spread out across several months or a year Are all vaccine types being borrowed or just one
bull If borrowing seems to be an issue discuss vaccine management ordering procedures
Resources bull Vaccine Borrowing Report on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfc formshtml)
bull Section 10 in the MnVFC Policies and Procedures Manual
Page 28 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 36
3 Documentation Vaccine Management Plan
Question 36 Physically review the providerrsquos Vaccine Management Plan to answer the question below
A Does the provider have a Vaccine Management Plan Yes No [X] (If no skip to question 37)
B Does the plan list the current Immunization Manager Vaccine Coordinator andback-up
Yes No [X]
C Does the plan address proper vaccine storage and handling practices Yes No [X]
D Does the plan specify vaccine receiving procedures Yes No [X]
E Does the plan contain procedures for what to do with vaccine in the event of an emergency
Yes No [X]
F Does the plan contain procedures for vaccine ordering Yes No [X]
G Does the plan address inventory control (example stock rotation) Yes No [X]
H Does the plan address how to handle vaccine wastage Yes No [X]
I Does the plan address staff training and documentation on vaccine managementstorage amp handling
Yes No [X]
J Does the plan contain a review date that falls within the last 12 months Yes No [X]
K Has the plan been signed by the individual responsible for its content Yes No [X]
Review CDC Requirement
VFC providers must develop maintain and implement a Vaccine Management Plan for routine and emergency vaccinemanagement The plan must contain the current Vaccine Coordinator and back-up proper storage and handling practicesshipping and receiving procedures emergency procedures procedures for vaccine ordering inventory control (eg stock rotation)how to handle vaccine wastage and staff trainingdocumentation on vaccine management storage and handling The plan must bereviewedupdated annually or more frequently if changes occur A ldquoreview daterdquo and signature are required on all plans in order tovalidate that they are current
Goal of this question Evaluate the sitersquos plan for vaccine management It is especially important that they have a plan for emergency management of their vaccine in the case of equipment failure or power outage Encourage all sites to read and sign the MnVFC Policies and Procedures Manual and complete the emergency plan or be able to show you a plan of their own
If the provider is not able to physically show you the plan at the time of the visit or if the recorded review date is not within the last 12 months you must mark that this requirement is unmet The Vaccine Management Plan is important in times of emergency and it should be easy to access by any staff member at any time Encourage them to post the plan and put a copy with the packing supplies
Helpful information bull Encourage the site to fill in the ldquoImmunization Managerrdquo and ldquoVaccine Coordinatorrdquo fields in the
MnVFC Policies and Procedures Manual for their own referencebull The emergency plan in the manual can be reviewed from last year and included in this yearrsquos manual (with an updated signature and date) if there have not been any changes
bull If information in the plan is outdated site staff will not be well equipped to safely manage vaccines in the event of a power-outage or other emergency situation
bull If their institutional policy is only reviewed and updated every 3-4 years (as many are) the staff may need to sign the MnVFC Polices and Procedure Manual to meet this requirement
Resource Routine Vaccine Management Plan and Emergency Vaccine Management Plan in the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 29
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 37
3 Documentation VIS amp VAERS
Question 37 Review the providerrsquos Vaccine Information Statements (VISs) and discuss providerrsquos VAERS process toanswer the questions below
A Does the provider have readily available up-to-date VISs for all ACIP-recommendedvaccines relevant to the populations it serves
Yes No [X]
B Does the provider make a VIS available for patientsparents before eachvaccination
Yes No [X]
C Does the provider know how and when to report clinically significant adverseevents using VAERS
Yes No [X]
Review CDC Requirement
VFC providers are required to distribute the current Vaccine Information Statements (VIS) each time a vaccine is administered and maintain records in accordance with the National Childhood Vaccine Injury Act (NCVIA) which includes reporting clinicallysignificant adverse events to the Vaccine Adverse Event Reporting System (VAERS) For a list of current VISs visit CDCrsquos Vaccine Information Statements (httpwwwcdcgovvaccineshcpvis) website
Gal of this question Ensure the site has the most current VISs and is giving them to each patientparent before administering the vaccine in compliance with the federal law Parents must be educated about the vaccine their child will receive and be aware of possible contraindications and side-effects in order to make well-informed decisions about their childrsquos health
Helpful information bull Ask to see the sitersquos VISs to determine if they have an active protocol for giving VISs to parents Review to make sure they are current Ask if they know where and how to report vaccine adverse events
Resources bull Section 3 in the MnVFC Policies and Procedures Manual bull CDC Vaccine Information Statements (wwwcdcgovvaccineshcpvisindexhtml) Site may sign up for email updates for the current list of VIS publication dates for the most up-to-date version
bull IAC Itrsquos Federal Law You must give your patients current Vaccine Information Statements (wwwimmunizeorgcatgdp2027pdf)
bull VAERS (httpsvaershhsgovindex)
Question 38
3 Documentation Anaphylaxis protocol
Question 38 Does the site have an anaphylaxis protocol which is clearly posted near the emergency kit
Answers (Choose one)
Yes No [X]
Review CDC Requirement
An anaphylaxis protocol must be clearly posted in the area where vaccines are administered
Goal of this question Make sure site is prepared for a severe allergic or anaphylactic reaction to a vaccine
Resources bull Section 11 in the MnVFC Policies and Procedures Manual bull IAC protocols Child and Teens (wwwimmunizeorgcatgdp3082apdf) and Adults (wwwimmunize orgcatgdp3082pdf)
Page 30 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
i
i i i - li i i i i i l
Section 4 Storage amp Handling Per Unit The goal of this section is to assess vaccine storage
2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet practices in each unit at the site MnVFC PIN ___________________
The 2017 MnVFC Storage amp Handling Per Unit Answer Sheet is a worksheet to document the answers to the questions in this section for each unit (combination or stand-alone) Fill in the answers to the questions in Section 4 on the answer sheet not in the questionnaire
The answer sheet has an abbreviated form of each question If you need further information on that question refer back to the full questionnaire Also if you find an area where the site is not meeting the requirements you will need to go back to that question on the 2017 MnVFC Site Visit Questionnaire to complete ldquoActions if Non- compliantrdquo section including the root cause analysis and follow-up sections If there is a problem in more than one unit make a note on the questionnaire which unit you are referring to in the Notes section
Important You must fully assess any unit that may be used to store VFC vaccines even if there are no VFC vaccines there on the day of the visit If there are no vaccines and the site is not documenting twice a day temperatures discuss the need to ensure the unit is maintaining stable temperatures by monitoring for one week before placing vaccines in the unit
Quest on number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
for the freezer and e co umn
Temperature Monitoring Dev refr gerator f the un
ce Quest ons Quest ons 4 3 4 7 must be answered separate y t s a combo Be sure to document responses n the appropr at
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
44D Data downloaded and reviewed routinely (eg weekly)
Yes No [O]
Yes No [O]
45A Certificate of Calibration Testing Yes No [X]
Yes No [X]
45B Date of calibration
45C Date certificate expires [X] Follow-up is required if expired [X] Follow-up is required if expired
45D Certificate contains all necessary items
Yes No [X]
Yes No [X]
46 Probe properly placed Yes No [X]
Yes No [X]
47A Two temperature readings per day
Yes No [X]
Yes No [X]
47B Time date and name (or initials) for each reading
Yes No [X]
Yes No [X]
47C Current temperature and minmax temperatures (if
Current ________deg Minimum ________deg Maximum _deg
Current ________deg Minimum ________deg Maximum _deg
Sections 5 and 6 contain questions about storage and handling site wide and inventory It is helpful to keep those questions in mind as you assess the individual storage units Think about dorm-style units expired vaccine vaccine supply room for vaccine stocking all the recommended vaccines and separation of stock if appropriate
NOTE The sections that follow require reviewers to validate responses by looking at vaccine storage units temperaturemonitoring equipment and the vaccine inventory inside a unit bull For section 4 use a separate Storage amp Handling Per Unit Answer Sheet for each unit to document the findings (combination
units using both sections can be documented on the same answer sheet) bull When an unmet requirement is identified return to this questionnaire to complete the ldquoActions if Non-compliantrdquo section for
that question bull After you complete one answer sheet for each unit return to the questionnaire to complete sections 5 and 6 using information
you gathered while assessing the units The questions in sections 5 and 6 (Storage amp Handling Site-Wide and Inventory) are notunit-specific but do require that the response be based on a thorough assessment of all the providersrsquo units
4 Storage amp Handling Per Unit
Description On the Storage amp Handling Per Unit Answer Sheet place a name that will allow you or someone else from your program to easily identify this unit in the event of follow-up We recommend using Brand + Location(example Samsung - Room 123) Save each Storage amp Handling Per Unit Answer Sheet with the Brand + Location in the file name
(example SamsungRoom123doc)
IPI Advisor Manual | February 2017 Page 31
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 41
4 Storage amp Handling Per Unit Storage Unit Build amp Use
Question 41 Below select the build and use of the vaccine storage unit you are assessing
Note to Reviewer Dorm-style units Do not add dorm-style units here Dorm-style units will be addressed in section 5 Units storing only private stock You must review these storage units even if they contain only private stockat the time of the visit because that vaccine could be administered to VFC patients
A What type of unit is this A Stand-alone B Combination
B Select use if stand-alone A Freezer B Refrigerator
Select use if combination A Use both sections to store vaccine B Use freezer section only to store vaccine C Use refrigerator section only to store vaccine
Goal of this question Identify the unit you are evaluating The description asks you to create a unique name for this unit so that you will be able to identify the same unit in future site visits Put this description on the top of the answer sheet (ie make and location)
Helpful information bull A stand-alone unit is either a refrigerator or a freezer It does not have both sections in the unit bull If there is a combination unit note if the site uses both the refrigerator and freezer or only one section of the unit to store vaccines CDC does not recommend the use of either section or the freezer section only of combination household units
bull If your site utilizes the separate stock method of vaccine management you must review storage units even if they contain only private stock at the time of the visit because there is a chance that those vaccines could be administered (borrowed) to VFC-eligible patients
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Question 424 Storage amp Handling Per Unit CDC Recommended Storage Units
Question 42 Below document the grade of the vaccine storage unit you are assessing
Note to Reviewer Pharmaceutical Also called ldquopurpose-builtrdquo these units are designed by the manufacturer specifically tostore vaccines or other biological materials Commercial Although usually intended to store food and beverages commercial units are often larger and more powerful than the household units found in most homes Though these units are intended to meet thehigher demands of larger facilities these units are not specifically built for the storage of biologicalmaterials Household (non-commercialdomestic) These units are usually smaller than commercial units and areintended for use in small offices and in homes ndash typically for food storage However just like commercialunits they are not designed specifically for the storage of biological materials Such units are usually available in common home supply stores
Answers (Choose one)
Select grade A Pharmaceutical B CommercialHousehold
[O] CDC does not recommend the use of both sections or the freezer section only of combination commercialhousehold units
Review CDC Recommendation
CDC recommends the following vaccine storage unit types (in order of preference) pharmaceutical grade stand-alone orcombination units (preferred) householdcommercial stand-alone units householdcommercial combination units using therefrigerator section only
Goal of this question Assess the grade and type of each storage unit bull Pharmaceutical grade units may be stand-alone or combination units that are often metal may have glass in the door for viewing inside often have an external digital temperature display and are manufactured by medical companies
bull Commercial or household units often look like your kitchen appliance have vegetablemeat drawers in the unit and are manufactured by household appliance companies
bull Occasionally you might find a medical grade unit which is usually a commercialhousehold unit with a lock and 3-prong plug These are still considered household units because of their ability to maintain proper temperatures and air flow Studies show that household stand-alone units are better able to maintain consistent temperatures than their combination counterparts Combination household units used to store vaccine in both sections of the unit is no longer recommended and may be prohibited in the future Combination household storage units that are having difficulty maintaining a cold enough freezer temperature and a warm enough refrigerator temperature should be replaced or a separate stand-alone freezer should be purchased
For frozen vaccines the most cost effective solution is for the site to purchase a small stand-alone freezer The site may need time to budget for a stand-alone storage unit
Resources bull Replacing Combination Household Units Tip Sheet on IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml)
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The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 434 Storage amp Handling Per Unit Temperature Monitoring Device in the Unit
Question 43 Determine whether there is a temperature monitoring device in this section of the storage unit andanswer the questions
A Is there a temperature monitoring device in this section of thestorage unit
Yes No [X] (If no skip to question 47)
B Who is responsible for supplying the temperature monitoring device in this section of the storage unit Provider
Review CDC Requirement
Certificates of calibration testing provide confidence that the temperature monitoring device is measuring temperaturesaccurately All units storing VFC vaccines must have a calibrated temperature monitoring device with a current and valid certificateof calibration testing All certificates must contain modeldevice name or number serial number date of calibration testing (report or issue date) and Instrument Passed testingInstrument in Tolerance (Recommended uncertainty = +-05ordm C (+-1ordm F))
Goal of this question Assess whether there is a temperature monitoring device in the unit If the unit is not being monitored at all call MDH at 651-201-5522 for guidance
Helpful information bull This question does not ask whether the temperature monitoring device is working or the characteristics of the device These issues will be addressed later in the questionnaire
bull For part B the provider is always responsible for supplying the temperature monitoring device Even if their thermometer or data logger was originally from MDH it is their responsibility to ensure it is functional and calibrated
Resources bull Section 8 in the MnVFC Policies and Procedures Manual
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-
Question 444 Storage amp Handling Per Unit CDC Recommended Temperature Monitoring Device
Question 44 Assess the temperature monitoring device in this section of the storage unit to answer the questionsbelow
A Is the temperature monitoring device a continuous monitoring and recordingdevice (eg data logger)
Yes No [O] (Skip D)
B Does the temperature monitoring device have a probe in buffered material Yes No [O]
C Does the temperature monitoring device have a digital display that can beeasily read from the outside of this unit
Yes No [O]
D Is data downloaded and reviewed routinely Yes No [O]
Review CDC Recommendation
As of Jan 1 2018 all VFC providers must use continuous temperature monitoring devices (eg data loggers) to monitor vaccinesthat will be administered to VFC-eligible children Routine review and accessibility of temperature data is critical for determining whether vaccine has been properly stored and for assessing usability of vaccine that was involved in a temperature excursion Tomeet VFC Program requirements the device must also be equipped with bull A temperature probe bull An active temperature display that can be easily read from the outside of the unit bull The capacity for continuous monitoring and recording capabilities where the data can be routinely downloaded
The following are additional recommended features for these devices bull Alarm for out-of-range temperatures bull Current minimum and maximum temperatures display bull Low battery indicator bull Accuracy of +- 1degF (05degC) bull Memory storage of at least 4000 readings bull User programmable logging interval (or reading rate) recommended at a maximum time interval of every 30 minutes bull Use of a probe that best reflects the temperature of the vaccine (such as a buffered probe)
Goal of this question Assess the temperature monitoring device in the storage unit Note that these are all recommendations not requirements at this time
This is a great teaching opportunity for sites who do not currently have a continuous temperature monitoring device Beginning Jan 1 2018 all units that store MnVFC vaccine will be required to have a continuous temperature monitoring device (ie a data logger or a continuous temperature monitoring system) Unlike a minmax thermometer a continuous temperature monitoring device provides detailed information on all temperatures recorded at pre-set intervals For excursions it can provide information on when a temperature went out-of-range for how long and what the temperatures were This is essential information that vaccine manufacturers need to know to assess the viability of the vaccine following an excursion
Helpful information bull Sites are required to monitor and record temperatures twice daily however temperature excursions can easily occur in the 12 hours or longer between readings Continuous temperature monitoring can help manufacturers determine vaccine viability
bull Continue to encourage sites to document and evaluate minimum and maximum temperatures the storage unit reached since the last reading and respond appropriately to out-of-range temperatures
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The 2017 MnVFC Site Visit Paperwork Chapter 4
bull It is recommended that sites download and review data weekly Discuss with sites that reviewing temperature monitoring device data also includes responding appropriately if they identify out-of-range temps
bull There is sometimes confusion about the difference between a data logger and a continuous temperature monitoring system Here are some differences
Data Loggers Continuous Monitoring Systems Have an external display similar to thermometers May or may not have an external display Have a detachable probe Probe is usually attached to transmitter Need to be plugged into the computer or cradle to download information on a regular schedule
Wirelessly sends data to computer system
Create a file of data that needs to be saved on the computer
Data is stored within the system not a separate file
Doesnrsquot allow documentation of twice a day temperature checks in the file
May allow documentation of twice a day temperature checks within the system
More about the 2018 requirement for a continuous temperature monitoring device
Required Features bull The continuous temperature monitoring device must have Continuous monitoring and recording capabilities to track and record temperatures over time The capacity to routinely download temperature data to a computer (recommended at least weekly) or wirelessly transmit data Detachable probe in a bottle filled with a thermal buffer (eg bio-safe glycol) if the data logger needs to be detached in order to download data Active temperature display
Recommended Features bull MnVFC recommends continuous temperature monitoring devices with Alarm for out-of-range temperatures Accuracy within +-1degF (+- 05degC) Low battery indicator Display of current minimum and maximum temperatures Memory storage of at least 4000 readings User programmable logging intervals (eg the user can set how often the device records the temperature)
Note that these are all currently recommendations not requirements yet
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
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The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 45
Goal of this question Ensure the temperature monitoring device is properly calibrated The certificate of calibration testing means that the device has been tested and it is accurately measuring temperatures within established testing limits The certificate of calibration ensures that the device meets all the required components
Helpful information bull The provider is always responsible for having a current certificate of calibration (or copy) on-site
bull To be considered ldquovalidrdquo a certificate of calibration must contain these required elements Modeldevice name or number Serial number
4 Storage amp Handling Per Unit Certificate of Calibration Testing
Review CDC Requirement
Certificates of calibration testing provide confidence that the temperature monitoring device is measuring temperaturesaccurately All units storing VFC vaccines must have a calibrated temperature monitoring device with a current and valid certificateof calibration testing All certificates must contain modeldevice name or number serial number date of calibration testing (report or issue date) and Instrument Passed testingInstrument in Tolerance (Recommended uncertainty = +-05ordm C (+-1ordm F))
Question 45
Note to Reviewer
A
B
C
D
E
Review the certificate of calibration testing for the temperature monitoring device in this section of the storage unit and answer the questions below
bull How to determine certificate of calibration testing expiration date 1) Identify the certificate issuecalibration date 2) Apply the Immunization Program-required frequency for calibration testing Example If the
issuecalibration date is 12312013 and Immunization Program policy requires testing every twoyears the expiration date is 12312015
bull Certificates must include all of the below bull ModelDevice Name or Number bull Serial Number bull Date of Calibration Testing (Report or Issue Date) bull Instrument Passed testing (Instrument in Tolerance)
Is there a certificate of calibration testing for the temperature monitoring Yes device in this section of the storage unit No [X]
What is the date of calibration for the temperature monitoring device in this section of the storage unit
What is the certificatersquos date of expiration based on ImmunizationProgram policy (See note to reviewer to determine expiration date) [X] Follow-up is required if
certificate is expired
Does the certificate contain all the necessary items listed in the Note to Yes Reviewer No [X]
Who is responsible for supplying the current and valid certificate of Provider calibration for this temperature monitoring device
Date of calibration testing (report or issue date) Note If there is no expiration date the certificate expires 2 years from the date of calibration Whether the instrument passed or failed testing (or instrument in tolerancenot in tolerance)
bull Recommended element Documented uncertainty of +- 1degF [05degC]
If these elements are present the certificate is considered valid If the certificate contains information about the recommended element or the entity that issued the certificate that is helpful but not required
To determine if a certificate of calibration testing was issued by an appropriate entity check to see if the certificate indicates one or more of these items (this is the wording used to help sites evaluate if their calibration is accurate but is not required on the certificate itself to be considered valid)
bull Conforms to ISO 17025 bull Performed by an ILACMRA Signatory body accredited laboratory You can review this list of the ILAC MRA and Signatories (httpilacorgilac-mra-and-signatories)
bull Traceable to the standards maintained by NIST bull Meets specifications and testing requirements for the American Society for Testing and Materials (ASTM) Standard E2877 tolerance Class F (le 05 degC) or better
bull Includes reference to another acceptable accuracy validation method such as comparison to other traceable reference standards or tests at thermometric fixed points
Note CDC recommends that certifications be issued for the entire monitoring unit (detachable probe data logger etc) and not individual certificates for each component
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The 2017 MnVFC Site Visit Paperwork Chapter 4
For 45 E the provider is always responsible for supplying the current and valid certificate of calibration for a temperature monitoring device
bull Tip If the temperature monitoring device has a sticker on the back with the calibration date the site can usually call the company who calibrated the device and get a copy of the certificate if they donrsquot have one
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 46 4 Storage amp Handling Per Unit Probe Placement
Question 46 Is the probe properly placed in this section of the storage unit
Note to Reviewer ldquoProperlyrdquo means that the probe in a commercial or household unit is placed in a central area of the unitdirectly with the vaccines Probes should not be placed in the doors near or against the walls close to vents or on the floor of the unit The only allowable exemption related to this requirement is for providerswho have pharmaceutical storage units (built for vaccine storage) that have either (1) a built-intemperature monitoring device OR (2) a dedicated port for the probe that dictates the placement of theprobe
Answers (Choose one)
Yes No [X]
Review CDC Requirement
The probe must be placed in a central area of the section of the storage unit directly with the vaccines in order to properly measurevaccine temperature The probe should not be placed in the door near or against the walls close to vents or on the floor of theunit For pharmaceutical units with a built-in temperature monitoring device or a dedicated port for a probe that is not in thecenter of the section of the storage unit consult your Immunization Program for guidance on placement
Goal of this question Make sure the temperature monitoring device is in the best location to accurately measure the temperature of the vaccines stored in the unit
Helpful information bull The probe of the temperature monitoring device should be placed directly with the vaccines in the middle of the unit The ONLY allowable exception is for pharmaceutical storage units that have either a built-in thermometer or a dedicated port for the probe that indicates placement of the probe
bull Temperatures can vary within the unit especially household units bull Call MDH at 651-201-5522 if you have questions
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Guide (wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml)
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Question 474 Storage amp Handling Per Unit Temperature Documentation
Question 47 Review the temperature documentation over the past three months for this section of the storage unit todetermine whether the provider has a process in place for properly documenting temperatures twice aday Answer the questions below
A Are there two temperature readings recorded for this section of the storage unit per day
Yes No [X]
B Is there a time date and name (or initials) recorded for each reading Yes No [X]
C What is the current temperature and minmax temperatures (if available) inthis section of the storage unit Use the reviewerrsquos thermometer if the providerrsquos temperature monitoringdevice does not have a current valid certificate of calibration testing or the probe is not properly placed in this section of the storage unit
Current Temperature Minimum Temperature Maximum Temperature Fahrenheit Celsius
D Based on your review of the providerrsquos recent temperature documentationincluding the current temperature is this section of the storage unitmaintaining appropriate temperatures
Yes No [X] Not enough information [X]
Review CDC Requirement
Vaccines must be stored under appropriate temperatures as described in the package inserts at all times Acceptable temperature ranges vary by vaccine type and the range is 36deg F and 46deg F (2deg C and 8deg C) and for frozen vaccines the range is -58deg F and +5deg F (shy50deg C and -15deg C) Exposure to temperatures outside of those included in the package inserts could affect vaccine viability andultimately could leave children unprotected against vaccine-preventable diseases In order to maintain awareness of storage unittemperatures and ensure that vaccines are being stored at appropriate temperatures at all times VFC providers are required to monitor and document temperatures for all vaccine storage units at least twice a day Temperature documentation must contain (1) at least two temperature readings per day (2) the time and date of each reading and (3) the name (or initials) of the personwho assessed and recorded the readings CDC also recommends that VFC providers record the minimum and maximumtemperatures of each unit once each workday (preferably in the morning)
Goal of this question Ensure the temperature is being monitored twice daily is within the required range and documented correctly Use your thermometer to check the temperature if the sitersquos temperature monitoring devicersquos probe is not properly placed or there is not a current certificate of calibration Place your thermometer in the unit at the beginning of the visit to allow sufficient time to reach an accurate temperature The purpose of using your thermometer is to ensure the vaccine is being stored at the proper temperature not to ldquovalidaterdquo their reading
Question 47 D is an assessment question based on information you have learned during your visit You might answer ldquonot enough informationrdquo if the unit is new and they donrsquot have at least three months of data or if the unit is only used as overflow and they are inconsistent with temperature monitoring Mark ldquoNordquo if you have reason to believe the storage unit is not maintaining temperatures properly
Helpful information bull All sites must document temperatures twice a day every day the site is open even if they have a data logger or continuous monitoring system
bull Sites can document the information electronically with some continuous monitoring systems as long as it can show what the current temp is the date time and initials of the person checking ndash this needs to be someone at the site ndash not checking remotely or centrally for a large site or system The site must be able to produce these records during their site visit Reviewing these files can be a challenge due to large volumes and lots of paper
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Temperature Logs on Managing Vaccine (wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml)
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Question 484 Storage amp Handling Per Unit Temperature Excursions
Question 48 In the event that a temperature excursion(s) occurred in this unit within the last three months requestand review documentation of actions taken to determine whether the provider has a process for properlyaddressing excursions Answer the questions below
A Were vaccines in this unit exposed to out-of-range temperatures in the lastthree months (including today)
Yes No (If no skip to question 49)
B Did the provider quarantine and label vaccines as ldquoDo not userdquo Yes No [X]
C Did the provider place vaccine in a unit where it can be stored under properconditions if applicable
Yes No [X]
D Did the provider contact the Immunization Program to report theexcursion
Yes No [X]
E Was the manufacturer contacted for documentation supporting theusability of the vaccine
Yes No [X]
Review CDC Requirement
The provider must document all excursions and actions taken including the following (1) Quarantine and label vaccines as ldquoDO NOTUSErdquo (2) Place vaccines in a unit where they can be stored under proper conditions (3) Contact the Immunization Program to report an excursion and (4) Contact the vaccine manufacturer to obtain documentation supporting the usability of the vaccine
Goal of this question Address any out-of-range temperatures (temperature excursions) identified in reviewing the last three months of temperature logs or during the site visit If there were any out-of-range temperatures did the site respond appropriately to the situation This is a great opportunity to discuss what to do in the event of an excursion The Clinicians Storage and Handling Mishap Checklist is in the IPI Site Visit information folder and is a good review of the process
Helpful information bull Sites need to know that an excursion does not automatically mean that exposed vaccines are non-viable or unusable Exposed vaccines must be quarantined (marked ldquoDo Not Userdquo) and stored under proper conditions until they have received information from vaccine manufacturers regarding the viability of the vaccine
bull Sites must inform MDH when an excursion occurs
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Clinicians Storage and Handling Mishap Checklist (wwwhealthstatemnusdivsidepcimmunize ipivaxchklstpdf)
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Question 49
Goal of this question Ensure proper placement of vaccines in the storage unit
Note These are all recommendations (best practices) not requirements
Helpful information bull Store vaccine in the middle of the compartment two to three inches away from the coils walls floor and cold air vent The temperature near the floor and walls of the unit differs from that in the middle of the compartment and the cold air vent can freeze refrigerated vaccines
4 Storage amp Handling Per Unit Vaccine Placement
Question 49 Look inside the unit to answer the questions below
A Are vaccines placed in the middle of the unit with space between vaccinesand the sideback of the unit to allow cold air to circulate
Yes No [O]
B Are vaccines stored in their original packages Yes No [O]
C Are there water bottles (for refrigerators) or frozen water bottles (forfreezers) in the unit
Yes No [O]
D Are vaccines store in the doors vegetable bins under or near cooling ventsor on the floor of the unit
Yes [O] No
E Is food being stored in the unit Yes [O] No
Review CDC Recommendation
Vaccines should be stored in their original manufacturer (or CDC centralized distributor) packaging They should be placed in the middle of the unit with space between the vaccines and the sideback of the unit to allow cold air to circulate Vaccines SHOULD NOT be stored in the doors vegetable bins or floor of the unit or under or near cooling vents and there should not be any food inthe unit Water bottles (for refrigerators) or frozen water bottles (for freezers) should be placed throughout each storage unit inorder to (1) stabilize or extend temperatures during a power outage and (2) to serve as physical blocks preventing the placementof vaccines in areas of the unit that are at higher risk for temperature excursions (such as in doors vegetable bins floor ornearunder cooling vents)
bull Vaccines should be kept in their original packaging to Protect them from light Help prevent medication errors by making labels easier to read Provide a moisture barrier that serves as insulation in case of an out-of-range temperature power outage door left open or mechanical failure Simplify managing vaccine inventory
bull Store water bottles in the doors on the floor and near the cold air vent in the refrigerator and frozen water bottles in the freezer to help maintain a stable temperature if there is a power failure and when the door is opened frequently Too many water bottles in the door can prevent the door from closing tightly Mark water bottles ldquoDo Not Drinkrdquo
bull Do not store vaccine in the door or drawers of the refrigerator or freezer Vegetable bins and crisper drawers should be removed from refrigerators or used to store other medical supplies or water bottles
bull If vaccine is stored in a household combination refrigeratorfreezer The top shelf should not be used for storing vaccine because the cold air vent blowing from the freezer will freeze vaccine located there If you must use the top shelf of this type of unit place water bottles underneath the cold air vent to prevent vaccine from being stored there It is recommended that only the refrigerator be used for vaccine storage and a separate stand-alone freezer be used to store frozen vaccine
bull Must not store food or beverages in the refrigerator or freezer because frequent opening of doors can lead to temperature variations that may affect vaccine viability There is also a risk of contaminating vaccines
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Guide (wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml) bull Vaccine Storage Tip Sheet on IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml)
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The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 4104 Storage amp Handling Per Unit Disconnection from Power Source
Question 410 Ask the provider to demonstrate what measures are taken to ensure that vaccine storage units are notaccidentally physically disconnected from the power supply Which of the following describes the measure(s) taken on this unit
Note to Reviewer bull Large hospitals and healthcare systems may not have the ability to demonstrate labels on plugs or circuitbreakers In such cases verify that the practice has a comprehensive policy and standard operatingprocedures in place to prevent the vaccine storage unit from being physically disconnected from thepower supply
bull While back-up generators may ensure power to the overall facility this question ONLY addresses thevaccine storage unit being accidentally disconnected from the power source either through the plug orthe circuit breaker
Answers A ldquoDo not disconnectrdquo labels on the plug (Choose all that B ldquoWarningrdquo label on the circuit breaker box
apply) C Hard-wired (ie built-in) and has a ldquoDo not disconnectrdquo label on thecircuit breaker box D Hospital or large health care system with a comprehensive written policyand standard operating procedures detailing measures taken to preventvaccine storage units from being accidentally disconnected from the powersupply E No acceptable measures for preventing accidental disconnection frompower supply [X]
[X] The response is non-compliant if only A only B or E is selected
Review CDC Requirement
VFC providers must take steps to protect the power source for all vaccine storage equipment by means of having clear warninglabels on both the plug and the circuit breaker associated with all vaccine storage units Large hospitals and healthcare systems canmeet this requirement by demonstrating that they have comprehensive policies and standard operating procedures to preventvaccine storage units from being physically disconnected from the power supply
Goal of this question Decrease the chance that a vaccine storage unit will be accidently unplugged or power will be turned off while vaccine is in the unit This question addresses only what measures the site has taken to ensure the storage unit is not physically disconnected from its power source
If the site uses labels on the plugs and circuit breakers perform a visual inspection to assess whether the way the stickers are positioned make it clear and obvious to anyone that these units are not to be disconnected
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Do Not Unplug and Warning stickers are included in the folder or available to order on the For
Professionals Order Form (wwwhealthstatemnusdivsidepcimmunizeordermathtml)
Note Once you have completed the 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet for each unit return to the questionnaire to complete sections 5 and 6
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-
- -
Section 5 Storage amp Handling Site-Wide Question 51
5 Storage amp Handling Site Wide Discussion of Cost amp Quantity of Vaccine
Question 51 Have a discussion with the provider about the cost and quantity of VFC vaccines they are responsible for annually Address the points listed in the note to reviewer below
Note to Reviewer bull Vaccine Shipped (Required) Share the cost of VFC vaccines shipped to the provider in the last calendaryear to make sure the provider understands the contribution made by the VFC Program to their practiceFor new providers who do not have ldquocalendar yearrdquo data share either the actual cost of their currentinventory or use the cost of 10 VFC doses of each of the ACIP-recommended vaccines (approximately $7000) to help estimate their annual cost
bull Storage amp Handling (Required) Make sure the provider understands the cost of vaccines for which they are responsible when they make decisions about purchasing recommended vaccine storage and temperature monitoring equipment
Answer I have discussed with the provider the cost and quantity of vaccines ordered in the previous calendar year
Goal of this question Inform sites of the quantity and value of vaccines that they receive as part of the MnVFC program Providers often donrsquot realize the value of the vaccine in their unit This information is included on your clinic list and on the one page site-specific information
Helpful information bull This discussion must occur and the box on the questionnaire must be checked bull If there isnrsquot actual vaccine value information available tell the site that one vaccine order that includes a box of each of the ACIP recommended vaccines costs approximately $7000
bull MDH may not have specific information for individual sites if they receive vaccine from a central warehouse or pharmacy For those sites MDH will give you numbers for the whole system so you can discuss system wide data as appropriate If individual site information is also included it is usually just varicella-containing vaccines that must be shipped directly to the site
Question 52
5 Storage amp Handling Site Wide Dorm Style Units
Question 52 Determine whether the provider has any dorm-style units on site and answer the questions below
Note to Reviewer A dormitory-style refrigerator is a unit that has both refrigerator and freezer compartments behind a singleexterior door Dorm-style units also have an evaporator plate (cooling coil) which is usually located insidean icemaker compartment (freezer) within the refrigerator
A Does the provider have any dorm-style units that are used at any time tostore vaccines
Yes [X] No (Skip to question 53)
B Does the provider have sufficient space in existing compliant vaccinestorage units to store all vaccines without use of the dorm-style unit at any time
Yes No [X]
Review CDC Requirement
Dorm- and bar-style units are prohibited for vaccine storage Vaccines stored in dorm-style units are considered non-viable and must be returned to the centralized distributor CDC recommends the following vaccine storage unit types (in order of preference)pharmaceutical grade stand-alone or combination units (preferred) householdcommercial stand-alone unitshouseholdcommercial combination units using the refrigerator section only
Goal of this question Ensure no vaccine is stored in dorm-style units even for short periods of time Encourage them to label any units ldquoNo Vaccine Storage Allowedrdquo Vaccine stored in these units is considered non-viable If a site is using a dorm-style unit call the MnVFC program (651-201-5522)
Resource Section 8 in the MnVFC Policies and Procedures Manual
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-
Question 535 Storage amp Handling Site Wide Storage Unit Space Availability
Question 53 Does the provider have sufficient room across storage units to store current stock as well as anyadditional stock acquired during peak season without overcrowding
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have sufficient storage space to accommodate vaccine stock at the busiest time of year without overcrowding
Goal of this question Ensure that sites have sufficient space in their units to maintain vaccines at the busiest time of year Overcrowding of vaccine limits air circulation and affects the unitrsquos ability to maintain stable temperatures
Helpful information bull Look for signs of overcrowding such as vaccines that are pushed up against the wall bins that are overflowing or storage units that are full during non-peak seasons
Discuss immediate actions if the unit is overcrowded Move some of their vaccines order less vaccine more frequently (once per month preferably) andor purchase another storage unit for overflow
Resource bull Section 8 MnVFC Policy and Procedure Manual
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-
Question 545 Storage amp Handling Site Wide Expired Vaccines
Question 54 Look in each unit Are there expired vaccines in any of the vaccine storage units at this site
Answers (Choose one)
Yes [X] No
Review CDC Requirement
Vaccines should be rotated weekly and when a new shipment comes in so that longer-dated vaccines are stored behind shorter-dated vaccines If vaccines expire they can no longer be stored in the same storage unit with viable vaccines They must be placedin a container or bag clearly labeled ldquoDo not userdquo and separated from viable vaccines to prevent inadvertent use Expired vaccinemust be returned to the centralized distributor within six months of expiration
Goal of this question Ensure there is no expired vaccine in any storage unit
Helpful information bull Sites can prevent their stock from expiring by rotating vaccines every week andor when a new shipment arrives Longer-dated vaccines are stored towards the back of the unit and shorter-dated vaccines are up front
bull Pay attention to vaccines that expire within the next three months Consider transferring vaccine that will expire soon to another MnVFC-enrolled site that will use the vaccine preferably a site close by It is the transferring sitersquos responsibility to arrange the transfer of the vaccine Be sure to complete the MDH Vaccine Transfer Record form and send it to MDH If they are having difficulty finding a location to accept vaccine contact MDH
bull This is a great opportunity to educate sites about the MDH Nonviable Vaccine Form and the process for returning vaccine The VFC program does get some credit for taxes and fees on vaccine that is returned to the distribution center
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MDH Nonviable Vaccine Form and MDH Vaccine Transfer Record on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfcformshtml)
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The 2017 MnVFC Site Visit Paperwork Chapter 4
- -
-
Question 555 Storage amp Handling Site Wide Back up Thermometer
Question 55 Does the provider have a readily available back-up thermometer with a current and valid certificate ofcalibration testing
Note to Reviewer ldquoReadily availablerdquo means that the thermometer is available to perform twice-a-day monitoring for a unit asrequired CDC recommends that the back-up thermometer be maintained on site
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have a readily available back-up thermometer with a current and valid certificate of calibration testing Toprevent the certificates of calibration testing of the primary and back-up thermometers from expiring at the same time the date of calibration testing (or issue date) of the back-up thermometer should be different from the date of calibration testing (or issue date) of the primary thermometer As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meetsVFC program requirements
Goal of this question Ensure sites have one calibrated back-up thermometer onsite that is readily available in the event that the temperature monitoring device in unit fails transportation of vaccine is needed or there are other unexpected circumstances
Helpful information bull As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meets VFC Program requirements
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 56 5 Storage amp Handling Site Wide Preparation of Vaccine
Question 56 When does this provider prepare vaccine for administration to the patient
Note to Reviewer For mass vaccination clinics if one type of vaccine is offered providers may pre-draw up to 10 doses Ifusing pre-filled syringes pre-drawing also means activating the syringe by removing the needle guard orattaching a needle
Answers (Choose all that
apply)
Prepare dose immediately before administration Pre-draw doses for upcoming patients (in a regular clinicpractice) [O] Pre-draw up to 10 doses (in a mass-vaccination clinic) Pre-draw more than 10 doses (in a mass-vaccination clinic) [O] Other [O]
Review CDC Recommendation
CDC recommends preparing vaccines immediately prior to administration in order to assure viability of vaccine and prevent vaccinewastage Vaccines that are not administered immediately are at risk of exposure to temperatures outside of the required rangewhich can affect vaccine viability and ultimately can leave children unprotected against vaccine-preventable diseases
Goal of this question Discuss proper timing and preparation of vaccine(s) for administration These are recommendations not requirements
Helpful information bull Educate staff on the importance of preparing vaccine immediately before administration Pre-drawing of vaccines may lead to concerns related to vaccine viability potency sterility and wastage
Page 46 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 6 Inventory Question 61
6 Inventory Inventory Comparison
Question 61 Visually inspect storage units to determine if existing supply of vaccines proportionately mirrorspopulations served Choose the most accurate statement below
Note to Reviewer bull CDC recommends that providers maintain a four-week supply of inventory bull For this question do not take into account vaccine types that the provider does not order Here simply
make sure that overall the vaccines in the providerrsquos storage units are available in sufficient amounts toserve their patient population
Answers (Choose one)
The current vaccine inventory proportionately reflects the populations identified Only public stock is insufficient [X] Only private stock is insufficient [X] Both public and private stock are insufficient [X] Site uses the replacement method but does not appear to have enough vaccine for their population [X] Other [X]
Review CDC Requirement
VFC providers must order and stock routine vaccines in accordance with their patient population in order to prevent missedvaccination opportunities Having sufficient amounts of all stocks prevents the inadvertent use of VFC vaccines for non-VFC-eligiblepatients and vice versa
Goal of this question Assess whether the site is ordering appropriate quantities of vaccine for the population they serve at their site
Helpful information bull If the site sees 30 percent private-pay patients and 70 percent VFC the stock in their storage units should reflect that proportion If you donrsquot know you can ask the site about their population
bull This is meant to be a general assessment so in a big site if they have only a small amount of vaccine that may indicate an issue with vaccine management
bull CDC recommends smaller more frequent orders (ie monthly) rather than large orders to minimize the amount of vaccine loss if an incident occurs during shipment or in the storage unit Sites should not order more frequently than once a month
bull Sites using the replacement method will only have one stock but it should appear to be large enough for their population
bull Only assess the vaccine types that the site currently stocks in their unit We know there are sites that do not offer all ACIP-recommended vaccines for various reasons That issue will be addressed in question 62
IPI Advisor Manual | February 2017 Page 47
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 626 Inventory ACIP Recommended Vaccines
Question 62 Review providerrsquos current inventory to answer the questions below
A Does the provider offer all routine ACIP-recommendedvaccines for their patient population
Yes (Skip to question C) No [X] Offers all except varicella because direct ship ofvaccine is unavailable from manufacturer
B Which routine vaccines are NOT being offered DTaP Hepatitis A Hepatitis B HIB HPV Influenza Meningococcal
MMR Pneumococcal Polio Rotavirus TdapTd Varicella
C According to Immunization Program Policy does theprovider make accessible all non-routine ACIP-recommended vaccines for those VFC patients whomeet the criteria for receiving them
Yes (Skip to question 63) No [X]
D Which non-routine vaccines are NOT being offered Pneumococcal polysaccharide vaccine (PPSV23) Meningococcal Group B (MenB) Other
Review CDC Requirement
VFC providers agree to comply with immunization schedules dosages and contraindications that are established by the Advisory Committee on Immunization Practices (ACIP) for the vaccines identified and agreed upon in the Provider Agreement UNLESS bull In the VFC providers medical judgment and in accordance with accepted medical practice the VFC provider deems such
compliance to be medically inappropriate for the child bull The particular requirements contradict state law including laws pertaining to religious and other exemptions The VFC program entitles children to the following vaccines DTaP Hepatitis A Hepatitis B HIB HPV Influenza MeningococcalMMR Pneumococcal Polio Rotavirus TdapTd and Varicella VFC providers are also required to ensure that VFC-eligible children have access to non-routine vaccines as needed
Goal of this question Assess if the site is offering all the ACIP-recommended vaccines for the population they serve and these vaccines are in stock on the day of the visit It is important that every MnVFC-eligible child that comes to a providerrsquos office for an immunization is vaccinated
Helpful information bull The Advisory Committee on Immunization Practices (ACIP) is a group of medical and public health experts that develops recommendations on how to use vaccines to control diseases in the United States
bull Specialty providers are not required to offer all routine vaccines but should provide the vaccines appropriate for their population
bull If the site does not offer all routine ACIP-recommended vaccines appropriate for their population check the ldquoNordquo box in Part A then check the appropriate box(es) in Part B for any vaccines not offered Please contact MDH as this situation offers us the opportunity to provide education to the site
bull For non-routine vaccines they must either be in stock or the site must have an alternative protocol in the routine management plan that ensures these children have access when applicable
Resources bull IAC Diseases and Vaccines (wwwimmunizeorgvaccines) bull CDC Advisory Committee on Immunization Practices (ACIP) (wwwcdcgovvaccinesacipindexhtml)
Page 48 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 636 Inventory Separation of Stock
Question 63 Observe how the provider differentiates stock in each storage unit to answer the questions below
A Is it clear which vaccines belong to public stock andwhich belong to private stock
Yes No [X] Not applicable replacement site
B Is it clear which vaccines belong to VFC stock andwhich belong to UUAV stock
Yes No [X] Not applicable replacement site Not applicable not UUAV-enrolled site
Review CDC Requirement
In order to ensure that VFC vaccines are only administered to VFC-eligible children VFC providers that serve both VFC and non-VFCshyeligible children must maintain their vaccine inventories in such a way that they can clearly differentiate public stock from privatestock as well as VFC from other public stock
Goal of this question Assess whether the site can distinguish between MnVFC vaccine and private vaccine If they participate in the Uninsured and Underinsured Adult Vaccine (UUAV) program they should also be able to distinguish between MnVFC stock and UUAV stock Some sites use labels bins boxes etc to differentiate their stock If it is not clear how the site differentiates their stock discuss vaccine management with the staff For follow-up call MDH to discuss doing a follow-up site visit
Sites using the replacement method will not have separate stocksmdashthis is an approved alternative method for keeping track of vaccine
Resource bull Section 10 of the MnVFC Policy and Procedure Manual
IPI Advisor Manual | February 2017 Page 49
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
MnVFC Site Visit Storage and Handling Per Unit Answer Sheet 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet MnVFC PIN ___________________
Question number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
Temperature Monitoring Device Questions Questions 43 47 must be answered separately for the freezer and refrigerator if the unit is a combo Be sure to document responses in the appropriate column
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
All the questions on the Site Visit Storage amp Handling Per Unit Answer Sheet have been discussed previously in section 4 of this manual Use this sheet to record information about all the units at the site visit You will need one sheet for each unit If it is a combination unit (either pharmaceutical or household) you can record both sections on one sheet If they have stand-alone units use one sheet for each unit Do not enter the answers to the questions in section 4 of the questionnaire
If you need more information about any of the questions refer back to the main questionnairemdashthe complete question additional guidance including notes to the reviewer and the CDC requirements are there Also if the site is not meeting the requirement you will go back to the questionnaire to complete the ldquoActions if Non-compliantrdquo section including the root cause analysis and follow-up sections
When you have completed the assessment of all the storage units remember to go back to the questionnaire to complete sections 5 and 6
Page 50 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
ndash
ndash
MnVFC Provider Follow-up PlanThe goal of the Provider Follow-up Plan is to communicate with the site all of the VFC requirements any unmet requirements found during your site visit and the timeline for completing the required action The left hand column is a box to check for ldquoUnmetrdquo requirements
Helpful information bull The form can be used to review what the site is doing well and what they need to work on
bull For requirements that have specific documentation that needs to be sent to you use the notes section
2017 MnVFC Provider Follow-up Plan Site _______________________________________________ MnVFC PIN ____________ Date of Visit ___________
Thank you for participating in this MnVFC compliance site visit Please review this visit summary including follow-up actions and timelines for completion Unmet MnVFC requirements and recommendations have a checked box next to them The goal of this plan is to support you with successfully implementing the program and improving access to vaccines for VFC-eligible children
Unmet Question VFC Requirements Section 1 Changes to Key Staff
Q12 Change in the Medical Director Immunization Manager Vaccine Coordinator or back-upKey Staff must be communicated to the immunization program by emailing healthmnvfcstatemnus Changes Notes
Q12 Key staff must complete the annual training on VFC program requirements and print theAnnual Training certificate of completion Documentation Required Action
Staff that have not completed the MnVFC online training must complete it and send acopy of the certificate to the reviewer Training can be found on the MnVFC website (wwwhealthstatemnusvfc) Due date 1 month
Notes
Unmet Question VFC Requirements Section 2 Eligibility
Q21 Provider staff must possess a working knowledge of all VFC eligibility criteria and use thoseVFC Eligibility criteria to screen children prior to administering VFC vaccines
Categories Notes
bull This form provides documentation needed for follow-up actions when you send your thank you email
The second to last page of the Provider Follow-up Plan has a summary of the MnVFC program recommendations These are to remind the site about best practices they may want to improve upon even though they are not yet requirements of the program For example you could discuss the recommendation about storage units if they currently have a combination household unit and are using both sections
The last section is for your signature and the person you met with In most sites it will be the immunization manager or vaccine coordinator who signs the form unless the medical director attended the site visit You keep the original copy and the site will need to keep a copy for themselves
To be completed by the site visit reviewer
I acknowledge that a VFC site visit was performed on __________________ (visit date) The follow-up plan which includes a list of all current VFC program requirements and recommendations assessed during the visit and any required follow-up actions was provided at the end of the visit
Site visit reviewer
Phone
Reviewer Signature Date
To be completed by the provider
I acknowledge that our practice took part in the VFC site visit noted above I understand the findings of the visit and any required actions that must be taken by our office in order to meet VFC program requirements
Medical Director (or designee) Name Title
Medical Director (or designee) Signature Date
IPI Advisor Manual | February 2017 Page 51
The 2017 MnVFC Site Visit Paperwork Chapter 4
After the Site Visit Send a thank you email highlighting the unmet requirements documents you need from the site to resolve the issue(s) and the date you need them Make sure to include the link to the Site Visit Survey (httpssurveyvovicicomseashxs=56206EE334CE0B14)
Please refer to Chapter 3 for more information about future follow-up required after the visit including forms and documentation
Resource bull Sample Thank You letter on IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml)
Chapter 5
IPI Advisor Resource List MnVFC Program 651-201-5522
MnVFC wwwhealthstatemnusvfc
bull Separate Stock and Replacement Method Policies and Procedures Manuals bull Online trainings bull MnVFC Announcements sign up to receive them via email bull Ordering MDH vaccine bull MnVFC forms Screening forms Reporting forms Others MDH Nonviable Vaccine Form MDH Vaccine Transfer Record and Vaccine Borrowing Report
bull MnVFC promotional materials bull Immunization Billing Guidance for MnVFC and Immunization Billing Guidance for MnVFC Replacement Sites Immunization Practices Improvement Program (IPI) wwwhealthstatemnusdivsidepcimmunizeipi
bull IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml) bull IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml) IPI Resource Folder Contents (wwwhealthstatemnusdivsidepcimmunizeipiipifolderpdf)
Minnesota Immunization Information Connection (MIIC) wwwhealthstatemnusmiic
bull MIIC regions and regional coordinators
Clinical Practice MDH Immunization Program wwwhealthstatemnusimmunize
Got Your Shots News wwwhealthstatemnusdivsidepcnewslettersgys
MDH Immunization Information for Health Care Providers wwwhealthstatemnusdivsidepcimmunizehcp
bull Got Your Shots A Providers Guide to Immunization in Minnesota bull Vaccine protocols bull Forms for tracking patient immunizations bull Immunization schedules for Health Care Providers Immunization Action Coalition (IAC) wwwimmunizeorg
bull Ask the Experts bull VISs (Vaccine Information Statements and translations) bull Administration screening questions bull Medical management of vaccine reactions bull Order form for Californiarsquos Immunization Technique DVD Best Practices with Infants Children and Adults
Page 52 IPI Advisor Manual| February 2017
IPI Advisor Resource List Chapter 5
CDC ldquoPink Bookrdquo wwwcdcgovvaccinespubspinkbookindexhtml
CDC Advisory Committee on Immunization Practices (ACIP) wwwcdcgovvaccinesacip
CDC Vaccines and Immunizations wwwcdcgovvaccines
VAERS reporting httpvaershhsgovindex
Storage and Handling Got Your Shots Providers Guide ndash Managing Vaccine wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml
MnVFC Guide to Temperature Monitoring Devices wwwhealthstatemnusvfc
MDH Clinicianrsquos Vaccine Mishap Checklist wwwhealthstatemnusdivsidepcimmunizeipivaxchklstpdf
MDH Vaccine Storage Guide wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml
CDC Vaccine Storage and Handling Toolkit wwwcdcgovvaccinesrecsstoragetoolkit
You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Vaccine manufacturer phone numbers wwwcdcgovvaccinespubspinkbookdownloadsappendicesFcontact-info-manufactpdf
IAC Checklist for Safe Vaccine Handling and Storage wwwimmunizeorgcatgdp3035pdf
IAC Donrsquot Be Guilty of These Errors in Vaccine Storage and Handling wwwimmunizeorgcatgdp3036pdf
Additional Resources Print materials from MDH ndash order forms wwwhealthstatemnusdivsidepcimmunizeordermathtml
Vaccine Education Center ndash Childrenrsquos Hospital of Philadelphia wwwchopeduservicevaccine-education-centerhomehtml
California Department of Public Health ndash Interactive training on vaccine administration and storage and handling handout on transporting vaccine and how to package wwwezizorg
IPI Advisor Manual | February 2017 Page 53
IPI Advisor Resource List Chapter 5
CDC vaccine price list wwwcdcgovvaccinesprogramsvfcawardeesvaccine-managementprice-listindexhtml
Vaccine Information Statements (VIS) wwwcdcgovvaccineshcpvisindexhtml
CEU Opportunities CDC Immunization Education and Training wwwcdcgovvaccinesedindexhtml
Immunization You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Page 54 IPI Advisor Manual| February 2017
- Introduction
-
- Welcome to the Immunization Practice Improvement (IPI) Program
- Contact Information
-
- Chapter 1
- Requirements to Participate in the MnVFC Program
- Vaccines for Children Program
- Chapter 2
- Reimbursement for MnVFC Visits
- Types of Visits
- Your MnVFC Clinical CoordinatorPlanner
- New IPI Advisor Training Requirements
- Your Role as an IPI Advisor
- Reasons MDH Would Do All or Part of a Visit
- Chapter 3
- Future follow-up
- Conducting the Visit
- Preparing for the Visit
- Information for the Visit
- Site Visit Checklist
- Scheduling the Visit
- Chapter 4
- After the Site Visit
- MnVFC Provider Follow-up Plan
- MnVFC Site Visit Storage and Handling Per Unit Answer Sheet
- Section 6 Inventory
- Section 5 Storage amp Handling Site-Wide
- Section 4 Storage amp Handling Per Unit
- Section 3 Documentation
- Section 2 Eligibility
- Section 1 Provider Details
- The Site Visit Reviewer Legend
- MnVFC Site Visit Questionnaire
- Required Paperwork for Site Visits
- Chapter 5
-
IPI Advisors Chapter 2
Reimbursement for MnVFC Visits Local public health agencies are paid for the site visits they conduct MDH will reimburse participating agencies only after we receive all of the required paperwork Paperwork submitted with incorrect or missing information may delay the reimbursement
IPI program reimbursement is processed on a quarterly basis and is processed in the month following each quarter through an electronic transfer of money Your agencycounty IPI advisor contact will receive an email notification of the reimbursement
Reimbursement rates are updated annually and available on the Contracts and Reimbursements (www healthstatemnusdivsidepcimmunizeipicontreimhtml) page
2017 MnVFC Site Visit Reimbursement Rates MnVFC Site Visit $400 Follow-up Visit$150 Education Visit$100 Unscheduled Visit$300
Reasons MDH Would Do All or Part of a Visit MDH may complete site visits or accompany you on a site visit if
bull The site is new to the MnVFC program (enrollment visit) bull The site has known issues or concerns regarding the MnVFC program especially if you are having difficulty resolving these issues
bull The site is refusing a site visit from local public health or yoursquore having a difficult time scheduling a visit
bull The site is part of tribal health or Indian Health Services bull MDH district epidemiologists will perform site visits at local health departments bull A new IPI advisor needs training from MDH staff bull Note MDH district epidemiologists will perform site visits at local health departments
Page 10 IPI Advisor Manual | February 2017
Chapter 3 Site Visits Scheduling the Visit
bull Check the information sheet or contact the site to confirm who the contact person is in charge of the MnVFC program In general this is the immunization manager or vaccine coordinator If the contact is no longer there ask for the person in charge of the sitersquos vaccines or the clinic manager They can usually direct you to the appropriate person You may want to follow a suggested phone script when contacting the site
Sample Phone Script for Scheduling a Visit
ldquoHello My name is _______ I am calling from ________ Health Department May I speak to (contact name) [If not available determine appropriate person to talk to or a better time to call back] I am calling to schedule a MnVFC site visit This visit will involve a review of immunization practices at your site We will look at vaccine administration storage and handling screening for eligibility and documentation of vaccinations It usually takes about two hours for a visit depending on the number of vaccine storage units you have Is there a day or time of day that works best for you
I have a pre-visit worksheet to send to you to help you prepare for the visit It contains information about what I will need at the visit such as temperature logs and immunization documentation information Completing this worksheet prior to me arriving will help the visit be more efficient Is there any other information that I can send to help you prepare for the visit
If you have any questions call me at ________ Thank you for your time and assistance I look forward to working with yourdquo
bull Arrange a date and time for the visit bull Let them know an approximate visit length Visits are usually around two hours long depending on the size of the site the number of vaccine storage units they have or if they have new staff
bull Request that key staff be present at the visit This could include the immunization manager vaccine coordinator immunization staff clinic manager nurse manager billing staff andor medical director
bull Inform your site contact that you will be sending them an email confirmation along with the MnVFC
Pre-Visit Worksheet
Site Visit Checklist Use the Site Visit Checklist on IPI Advisor Site Visit Materials (wwwhealthstatemnusdivs idepcimmunizeipisvmaterialshtml) to make sure all necessary steps are covered
MINNESOTA VA C CI N ES FO R CHI LD REN PROGRAM
Site Visit Checklist Date of visit Time
Site Name PIN
Address
Contact Phone
Complete Before the visit Comments
Review the clinic list Identify and prioritize which sites you will visit
Email or call to schedule a date and time for the visit Ask for the immunization manager or vaccine coordinator
Email appointment confirmation attach Pre-visit Worksheet and provide instructions for returning it prior to the visit (sample email on website) Include length of the visit and which staff should be present
Add site visit to Outlook calendar and reserve a car (if needed)
Review temp logs and Pre-visit Worksheet
Send a reminder email 2-3 days ahead of the visit
IPI Advisor Manual | February 2017 Page 11
i i li
Site Visits Chapter 3
Information for the Visit2017 MnVFC Pre-Visit Worksheet Site name MnVFC PIN
Address
Medical director Email
Immunization manager Phone
Vaccine coordinator Phone
Vaccine coordinator back-up Email
IPI Site Vis t Preparat on Check st
The staff listed have completed the MnVFC online training and printed a certification of completion Immunization Manager Vaccine coordinator Vaccine coordinator back-up
Have a copy of the most recent provider agreement
Check if the above listed staff have changed since the provider agreement was completed
Check all of the vaccines administered at your site and list the corresponding publication date for each VIS you give to patients
DTaP _____________ Hepatitis A _____________ Hepatitis B _____________ Hib _____________ HPV _____________
Influenza _____________ MCV4 _____________ MMR _____________ MMR-V _____________ PCV13 _____________
Polio _____________ Rotavirus _____________ Tdap _____________ Varicella _____________
Non-Routine Vaccines Men B__________ PPSV23 _____________ Td _____________
Vaccine administration fee charged for MnVFC eligible children is $
Have a Vaccine Management and Emergency Plan that has been reviewed and dated within the last year
Have the borrowing reports if applicable for the last 12 months available at the visit
Have an anaphylaxis protocol that is clearly posted and reviewed annually
Send an appointment reminder email and the MnVFC Pre-Visit Worksheet to the MnVFC contact A sample letter and the MnVFC Pre-Visit Worksheet can be found on the IPI Advisor Site Visit Materials (wwwhealthstate mnusdivsidepcimmunizeipisvmaterialshtml) page You can request that the MnVFC Pre-Visit Worksheet and temperature logs be sent to you prior to the visit for your review
Contact the site by phone or email one or two working days before the scheduled visit to confirm your appointment This is also a good time to ask for directions and parking information if you are not familiar with the site
Preparing for the Visit Review the site visit paperwork to familiarize yourself with the questions For most of the questions there is a ldquoNote to the reviewerrdquo These notes give helpful tips about the information you are looking for when asking this question It contains the rationale for the question and which resources to provide to the site to support the rationale Some sections also require immediate on-site actionsmdashthings you must do while you are at the site and some require future follow up
bull Print copies the of site visit paperwork bull Site visit forms are available on the IPI Advisor Site Visit Materials (wwwhealthstatemnusdivs idepcimmunizeipisvmaterialshtml) page 2017 MnVFC Site Visit Questionnaire 2017 MnVFC Site Visit Storage amp Handling per Unit Answer Sheet (print one for each stand-alone andor combination storage unit at the site) 2017 MnVFC Provider Follow-up Plan (print two copies)
bull Review any previous site visit paperwork that is available You should check in with MDH staff after your visits if the site continues to have the same issues as past visits
bull Also be sure to bring Your thermometers If the sitersquos certificate of calibration is expired or the probe is not properly placed place your thermometer in the storage unit when you arrive and read the temperature just prior to reviewing the site visit findings
The MnVFC folder with additional immunization resources you wish to add (see chapter 5) and the Vaccine Storage amp Handling magnet (to order email healthIPIinquiriesstatemnus) A copy of the appropriate MnVFC Policies and Procedures Manual found on the MnVFC website (wwwhealthstatemnusvfc) Appropriate temperature logs (Celsius or Fahrenheit) Site information sheet that contains the quantity and value of the vaccine distributed to the sitesystem
Page 12 IPI Advisor Manual | February 2017
Site Visits Chapter 3
Conducting the Visit Education is a large part of the MnVFC site visit Often approaching this visit as an exchange of information with the site is more successful than a ldquoregulatoryrdquo visit Putting the staff at ease answering their questions and making a plan to address issues that arise during the visit is more helpful than a ldquopassfailrdquo attitude Education will usually consist of providing the rationale for the requirement referring to the requirement in the MnVFC Policies and Procedures Manual and providing resources to help address the situation Some questions will require additional follow-up to assure the site has corrected the issue(s) and is meeting the MnVFC requirement(s) This will be addressed further in the follow-up section
Completing the Paperwork
There are three documents that you must complete for the MnVFC site visit bull 2017 MnVFC Site Visit Questionnaire bull 2017 MnVFC Site Visit Storage amp Handling per Unit Answer Sheet (one for each storage unit) bull 2017 MnVFC Provider Follow-up Plan (two copies or you may ask them to make you a copy of the completed form for their records)
Answer the questions on the MnVFC Site Visit Questionnaire based on how things are when you arrive at the site If they correct the issue during the visit you will still mark it as an unmet requirement and document how it was addressed during the visit
The ldquoAnswerrdquo field will contain all the possible answer choices for this question For most questions answer choices will be followed by the markings below
bull Answer choices with no marking mean the site meets the CDC requirement bull Answer choices marked with an [X] indicate that this specific answer choice is non-compliant with a CDC requirement
bull Answer choices marked with an [O] indicate that this specific answer choice is not aligned with a CDC recommendation
If you marked the box with the [X] which is non-compliant with the CDC requirement conduct a root cause analysis to determine the reason for non-compliance Root cause analysis is an important component to a successful site visit It is used to identify the cause of the problem and help to resolve the issue There are several possible root causes that can be identified Choose only one root cause
bull Human cause Personal beliefsopinions Does not understand rationale of requirement Lack of concern for compliance
bull Organizational cause Competing job assignmentsworkload Lack of (insufficient) staff to perform required duties Budget limitations (for required equipment) Lack of (insufficient) training of staff Lack of (insufficient) processesprotocols
IPI Advisor Manual | February 2017 Page 13
Site Visits Chapter 3
Once identified the root cause should be documented in the questionnaire including a brief explanation of why you chose that cause This allows for follow-up with the site and a way to help find improvements to meet the unmet requirement Complete any immediate on-site action These often require providing education and resources for the site Mark the box for each action taken If you provide additional resources or information you can use the notes section to indicate the additional items
ldquoFuture follow-uprdquo are actions the site needs to take to meet the requirements of the program Wersquoll go over more specific information about the site visit questionnaire in Chapter 4
Performing the Site Visit
As you become familiar with the MnVFC program and develop a relationship with your sites you will develop a visit pattern that works for you Here is one possible sequence for conducting MnVFC site visits
bull When you arrive at the site if you have a business card it is helpful to provide it to the front desk staff person
bull When you meet with the immunization manager andor vaccine coordinator introduce yourself and explain the expectations for the visit
bull Ask to see the temperature monitoring device(s) It must have a current certificate of calibration and the probe must be properly placed in the unit If it does not meet the requirements place your thermometer in the unit at the beginning of the visit so that it has sufficient time to reach an accurate temperature by the time you complete your assessment of the storage units
bull 2017 MnVFC Site Visit Questionnaire Ask all of the questions You may have to modify the order of the questions based on what is best for the site When you get to the storage and handling section (section 4) use the answer sheet(s) to document the answers to the questions for each storage unit that stores vaccine (MnVFC or private) Do not write answers in the questionnaire unless there is an unmet requirement Be sure to ask if there is vaccine stored anywhere else at any time at this location This includes a co-located pharmacy If so these additional units will need to be assessed as well If the site has a combination refrigeratorfreezer household unit and is using both sections discuss with them the recommendation (and probable future requirement) to have a separate freezer Refer to MDH if they have further questions or need more information Be prepared to address any storage and handling mishaps that you may find A copy of the
Clinicianrsquos Vaccine Mishap Checklist is with your visit materials and the Emergency Response Worksheet is in the MnVFC Policy and Procedure Manual If you are unsure how to handle the problem call the MnVFC program at 651-201-5522 during or after the visit
Page 14 IPI Advisor Manual | February 2017
Site Visits Chapter 3
Ending the Visit bull Fill out the two copies of the 2017 MnVFC Provider Follow-up Plan (or ask them to make a copy once it is completed for their records) Indicate if they have not met the requirement by checking the box in the ldquoUnmetrdquo column If they are not meeting requirements check the required actions Review the plan with them reinforcing the positive things they are doing as well as reviewing the required follow-up action(s) Give the site a copy of the Provider Follow-up Plan Keep the signed copy of the Provider Follow-up Plan to submit with your paperwork Do not leave a copy of the Site Visit Questionnaire at the site
bull Let them know you will be sending a thank you email that will summarize the site visit Included in the email will be a survey link you would appreciate them completing regarding the visit
After the Visit bull Send the site a thank you email There is a template thank you letter on the IPI Advisor Site Visit Materials (wwwhealthstate mnusdivsidepcimmunizeipisvmaterialshtml) page Be sure you include the issues that you identified and the timeline for their completion as well as the good things you found at the visit In the template letter be sure to include the survey link The survey is very brief ndash a few questions and space to write comments
bull Either transfer your MnVFC Site Visit Questionnaire and MnVFC Site Visit Storage amp Handling per Unit Answer Sheet information to the fillable version or submit the handwritten form to MDH
Documentation of the Visit
Paperwork must be submitted to MDH within 10 days of the visit in order to meet the federal VFC programrsquos reporting requirements Do not wait to complete your follow-up before submitting the site visit paperwork
Send the following documents to MDH bull 2017 MnVFC Site Visit Questionnaire (includes the cover sheet) bull 2017 MnVFC Site Visit Storage amp Handling per Unit Answer Sheet (one for each unit) bull 2017 MnVFC Provider Follow-up Plan (original signed plan)
Submit site visit materials to bull Email healthIPIinquiriesstatemnus (preferred) bull Mail IPI Program Specialist
Immunization Practices Improvement Program Minnesota Department of HealthPO Box 64975St Paul MN 55164-0975
IPI Advisor Manual | February 2017 Page 15
Site Visits Chapter 3
Future follow-up Follow-up is an important component of the site visit It helps us ensure that the unmet requirements have been corrected The questionnaire has different time periods for follow-up depending on the question Do not wait to complete your follow-up before submitting the site visit paperwork
When you complete the Follow-Up Form make sure to keep a copy for yourself MDH also keeps track of follow-up required and will remind you if follow-up has not been completed by the deadline Most follow-up can be done with a phone call or email In-person follow-up is rarely required and should be discussed with MDH before scheduling a follow-up visit
All requirements that need follow-up are identified with a [X] on the site visit paperwork and are listed on the MnVFC Provider Follow-up Plan
bull Follow-up with the site to see how they have resolved the unmet requirements bull Document your follow-up on the Follow-Up Form available on the IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml) page If follow-up was done via letter or email a copy can be attached to the Follow-Up Form
bull Send your Follow-Up Form to MDH (healthIPIinquiriesstatemnus) with supporting documents and emails
bull If a site is not responding to your requests regarding follow-up contact your MnVFC clinical coordinatorplanner They can help with additional follow-up as needed
Page 16 IPI Advisor Manual | February 2017
Chapter 4 The 2017 MnVFC Site Visit Paperwork This chapter will go through the required MnVFC site visit paperwork with notes about information or resources to help the site address questions or issues that may arise during the visit
The MnVFC site visit paperwork is available on the IPI Advisor Site Visit Materials (wwwhealthstate mnusdivsidepcimmunizeipisvmaterialshtml) page
Please download the paperwork shortly before your visit as there may be updates and changes and this will be the most up-to-date version of the questionnaire We will send out a Workspace message with major changes
Required Paperwork for Site Visits bull 2017 MnVFC Site Visit Questionnaire bull 2017 MnVFC Storage amp Handling Per Unit Answer Sheet ndash one for each unit assessed during site
visit bull 2017 MnVFC Provider Follow-up Plan ndash with provider signature
Make sure to include the sitersquos PIN on all your paperwork Please complete and submit your site visit paperwork as soon as possible after your visit It may be helpful to schedule some time into your calendar to complete your paperwork in the days following your visit Once you have completed the post-visit follow-up send in the Follow-Up Form with documentation of the follow-up actions Please do not wait until you have completed your follow-up before sending in your initial paperwork
MnVFC Site Visit Questionnaire The questionnaire includes these six sections 1 Provider details 2 Eligibility 3 Documentation 4 Storage amp handling per unit 5 Storage amp handling site-wide 6 Inventory
IPI Advisor Manual | February 2017 Page 17
Page 18 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
The Site Visit Reviewer Legend The legend explains the formatting of the 2017 questionnaire This includes information that will be helpful in completing the site visit
Site Visit Reviewer Guide Legend
Section Number Content Area
Question number This area will always contain the text of the question
Note to reviewer The note to reviewer contains information that is necessary for properly asking and assessing responses tothe question above This may include definitions of terms requirement details and other helpful tips
Answers This field will contain all the possible answer choices for this question For most questions answer choiceswill be followed by the markings below
Answer choices marked with an [X] indicate that this specific answer choice is non-compliant with a CDC requirement Answer choices marked with an [O] indicate that this specific answer choice is not aligned with a CDC
recommendation
Review CDC RequirementRecommendation
This field will be populated with the CDC requirementrecommendation associated with the given question
Actions if Non-Compliant
Root Cause Analysis As part of the site visit reviewers are required to assess and understand the reasons why a provider office isnon-compliant with VFC program requirements ndash this is a root cause analysis Reviewers must choose theone root cause that they believe most contributes to the non-compliance Upon establishing the root causethe reviewer must provide a clear explanation of hisher findings
Immediate Action These are actions that CDC requires reviewers to take on site during the visit
Future Follow-up These are future follow-up actions (with designated due dates) that are required of the reviewer andorprovider to remedy non-compliance Reviewers must complete all follow-up in accordance with CDCestablished deadlines
Notes Information you want the VFC program to be aware of or that explains your answer in detail
bull Note to reviewer These are notes to help you understand what the question is asking for and to clarify things you might want to know when asking or rephrasing the question
bull Answers This section helps you to know when the answer does not meet the CDC requirement [X] or recommendation [O] Whenever an answer with a [X] is checked the ldquoActions if Non-compliant section must be completed The recommendations are usually good teaching points about best practices andor future requirements of the VFC program
bull Review the CDC RequirementRecommendation This section provides a specific outline of the requirement or recommendation to give you information to use in talking with the site staff
bull Actions if Non-Compliant This section describes what to do if the site is not meeting a requirement Root cause analysis This section asks you to probe beyond the surface to find what is driving the non-compliance It is intended to help uncover reasons for recurring non-compliance issues identify additional training needs and inform reviewer follow-up actions Select only one root cause and explain the particular circumstances in the space ldquoExplanation of root causerdquo line provided If there appear to be multiple issues choose the one that most contributes to the non-compliance and describe all factors in the explanation Immediate actions A list of actions to take during the site visit to address the issue Future follow-up A list of actions to take after the site visit by the set deadline
bull Notes This section can be used for notes to yourself or to MDH
IPI Advisor Manual | February 2017 Page 19
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 1 Provider Details Questionnaire Coversheet
The first page of the questionnaire collects the demographic information for the site You can use this page to help prepare for the visit Most of the demographic information about the site should be on the site-specific document you received with your clinic list You will validate that this information is current at the time of the site visit It also helps to know if this is a separate stock site or a replacement site before the visit so you can bring a copy of the appropriate MnVFC Policies and Procedure Manual
2017 MnVFC Site Visit Questionnaire Date of visit _____________ Date forms sent to MDH ______________
Site Information
Site name MnVFC PIN
Address Separate Stock Replacement
City ZIP County
Medical Director Email
Immunization Manager Phone
Vaccine Coordinator Phone
Vaccine Coordinator back-up Email
Point of contact Phone
Personnel at site visit
On this page bull The date of the visit and the date when you send these forms to MDH This information helps us track the timeliness of our review and data entry process
bull The vaccine management method used by the site (replacement or separate stock) bull The name and email of the medical director (ideally this is the person who signed the MnVFC
Program Provider Agreement)bull Contact information for the immunization manager vaccine coordinator vaccine coordinator back-up and point-of-contact for this visit The immunization manager vaccine coordinator vaccine coordinator back-up roles are
described in the MnVFC Policies and Procedure Manual The vaccine coordinator back-up may be the immunization manager or another staff person depending on the size of the site and available personnel The Point of Contact is the person you set up the appointment with signs the Provider Follow-
up Plan and receives the follow-up email This may be one of the people listed above
The Post Visit Steps section is a reminder to you about what needs to done after the visit The Education on Immunization Best Practices for Sites section reminds you to provide the resource folder to the site
Page 20 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 12
1 Provider Details Changes to Key Staff
Question 12 Ask the provider about changes to key staff to answer the questions below
A (Choose all that
apply)
At the time of the visit is the Medical Director the same individual that signed the ProviderAgreement and are the Immunization Manager and Vaccine Coordinator the same asthose last reported to the program
Yes No the Medical Director has changed No the Immunization Manager has changed No the Vaccine Coordinator has changed
B (Choose one)
Were all changes communicated to theImmunization Program according to yourprogramrsquos policy
Yes or no staff changes No [X]
C (Choose one)
Based on review of the trainingdocumentation have the current Immunization Manager Vaccine Coordinator and back-up completed all required training
Yes No [X]
Review CDC Requirement
All changes in key staff must be communicated to the Immunization Program in the manner and timeframe defined by theImmunization Program Key staff include the Medical Director or equivalent who signed the Provider Agreement the Immunization Manager Vaccine Coordinator and the back-up VFC providers are required to ensure that all key staff are fully trained on VFC program requirements at all times All training must be documented
Goal of this question Determine if there are new staff in key positions at the site and to make sure staff are properly educated about the MnVFC program A This information can help you determine the level of knowledge and experience the staff have with the MnVFC program Follow-up throughout the visit can be tailored for various levels of staff experience Likewise you may identify additional training needs for new staff
B When sites notify us of changes in key personnel we update their information in MIIC and on the clinic lists We also send the new staff information for completing the online training and direct them to read the appropriate MnVFC Policies and Procedures Manual If the answer to this part is no update the demographic area of the questionnaire and inform the staff that in the future they must notify the MnVFC program (via email or phone) if the immunization manager or vaccine coordinator changes Resource Section 12 of the MnVFC Policies and Procedures Manual
C Annual training must be verified by looking at the certificates for the online training If the answer to this part is no refer the staff to complete the appropriate MnVFC online training found on the MnVFC website (wwwhealthstatemnusvfc) for their program (separate stockreplacement) for the current year and send you a copy of the certificate within 30 days
Resource bull Sections 12 and 14 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 21
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 2 Eligibility Question 21
Goal of this Question Assess whether staff correctly understand which patients are eligible for the MnVFC program Screening ensures that eligible children receive the vaccines that they are entitled to receive under the MnVFC program and helps to prevent fraud or abuse of the program
Children 18 years and younger in these
categories can receive MnVFC vaccine at any enrolled site bull Uninsured bull Enrolled in a Minnesota Health Care Program (MHCP) Medical Assistance (MA) or MinnesotaCare bull American Indian or Alaskan Native
The following categories are considered underinsured and are only MnVFC-eligible at local public health (LPH) Federally Qualified Health Centers (FQHC) Rural Health Centers (RHC) Indian Health Services (IHS) and tribal health clinics
bull Has health insurance that does not cover one or more vaccines as can be the case with newly licensed vaccines that arenrsquot yet covered (MnVFC-eligible for non-covered vaccines only)
bull Has health insurance that caps vaccine coverage at a certain amount Once that amount is reached the child is MnVFC-eligible
Children with insurance that does not cover vaccines until a deductible has been met are considered to be fully insured and are not MnVFC-eligible
Helpful information bull Sites are not required to verify the patientrsquos response to the screening questions For example if a patient states they lost their insurance the site does not need to call the patientrsquos insurance company to confirm
If the site cannot correctly describe the eligibility categories provide educational materialsresources on MnVFC eligibility requirements
Resources bull Patient Eligibility Screening Record on MnVFC Forms (wwwhealthstatemnusdivsidepc immunizemnvfcformshtml)
bull Section 1 of the MnVFC Policies and Procedures Manual
2 Eligibility VFC Eligibility Categories
Question 21 Was the individual responsible for determining patient VFC eligibility able to explain all the factors(including age) that make a child eligible to receive VFC vaccines
A Patient is less than 19 years of age Yes No [X]
B Patient is Medicaid-eligible Yes No [X]
C Patient is uninsured Yes No [X]
D Patient is underinsured Yes No [X]
E Patient is American Indian Yes No [X]
F Patient is Alaska Native Yes No [X]
Review CDC Requirement
VFC providers must possess a working knowledge of all VFC eligibility criteria and use those criteria to screen children prior toadministering VFC vaccines In order to receive VFC vaccine a patient must be under the age of 19 and must be at least one of the following (1) Medicaid-eligible (2) Uninsured (ie child has no health insurance) (3) Underinsured (ie child has health insurancebut coverage does not cover any or certain vaccines ndash underinsured children may only receive VFC vaccines in FQHCRHC ordeputized VFC provider offices and only for vaccines not covered by insurance) and (4) American Indian or Alaska Native (AIAN)
Page 22 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 22
2 Eligibility Billing Practices
Question 22 Is the individualdepartment responsible for billing able to clearly explain how they bill for both the costof vaccine and the vaccine administration fee for each of the eligibility categories below
A Medicaid-eligible Cost of Vaccine Do not bill ndash provided by VFC Admin Fee Bill Medicaid
Yes No [X]
B Uninsured Cost of Vaccine Do not bill ndash provided by VFC Admin Fee If billing can bill patient
Yes No [X]
C Underinsured Cost of Vaccine Do not bill ndash provided by VFC through FQHCsRHCs or deputized providers only all other providers cannotprovide VFC vaccine to underinsured patients Admin Fee If billing can bill patient
Yes No [X]
D American IndianAlaska Native(AIAN)
Cost of Vaccine Do not bill - provided by VFC unless patient is fully insured and parent chooses to use insurance Admin Fee If patient is Medicaid-eligible bill Medicaid if billingand patient is uninsuredunderinsured can bill patient if parentchooses to use private insurance for cost of vaccine billpatientinsurance
Yes No [X]
E Do individuals responsible for billing have access to the results of eligibility screening toensure proper billing
Yes No [X]
Review CDC Requirement
VFC providers must adhere to proper billing practices for vaccine administration fees and clearly understand that VFC vaccine isprovided at no cost to both the VFC provider and eligible children At no time should billing occur for the cost of VFC vaccine Whenadministering VFC vaccine providers should never bill two different ldquopayersrdquo (ie patient Medicaid insurance) for the samevaccine administration fee amount For Medicaid-eligible children Medicaid should be billed for the vaccine administration fee Forall other VFC-eligible populations the patient may be billed within the stateterritory cap established by the Centers for Medicareand Medicaid (CMS) However patients cannot be turned away or reported to collections for inability to pay the administration fee
Goal of this question Determine if the staff correctly understand how to bill patients that are eligible for the MnVFC program Billing appropriately ensures that children can receive low cost immunizations and the site is in compliance with the VFC program
bull If there is any indication that sites could be billing insurance companies or parents for VFC vaccines this should be investigated further
bull Most sites in Minnesota will bill Medicaid with the SL modifier ndash which indicates this is a Medicaid claim
bull The main point is to ensure the site is not billing uninsured children for VFC vaccine and are not charging them more than $2122 per vaccine for the administration fee
bull Non-compliance is usually unintentional and may be resolved with some training In rare cases it could be a glimpse into a larger problem where a site is intentionally billing for financial gain
bull If you think the site is billing inappropriately it is the responsibility of the IPI advisor to report concerns to MDH staff for further assistance
Resources bull Immunization Billing Guidance for MnVFC (wwwhealthstatemnusdivsidepcimmunizemnvfc billingtipshtml) or Immunization Billing Guidance for MnVFC Replacement Method Sites (www healthstatemnusdivsidepcimmunizemnvfcreplacementbillingtipsrephtml)
bull Section 2 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 23
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 232 Eligibility Vaccine Administration Fee
Question 23 Document the actual vaccine administration fee charged to non-Medicaid VFC-eligible patients (confirmwith billing department)
Answers Fee $ [X] Follow-up is required if the provider charges more than the fee cap establishedby the Centers for Medicare and Medicaid (CMS) for your stateterritory ($2122)
Review CDC Requirement
The VFC providerrsquos vaccine administration fee for non-Medicaid VFC-eligible children must not exceed the stateterritory vaccineadministration fee cap established by the Centers for Medicare and Medicaid (CMS) For current fee caps refer to Medicaid Program Payments for Services Furnished by Certain Primary Care Physicians and Charges for Vaccine Administration Under theVaccines for Children Program Final Rule (httpwwwgpogovfdsyspkgFR-2012-11-06pdf2012-26507pdf)
Goal of this question Ensure that sites are not charging more than the federal allowable vaccine administration fee of $2122
bull The Centers for Medicaid and Medicare (CMS) establishes a maximum fee that sites can charge to non-Medicaid-eligible VFC patients in each stateterritory for vaccine administration Health Plans usually negotiate this fee with the site but Medicaid will not pay more
bull If a parent cannot pay the vaccine administration fee the patient cannot be turned away or reported to collections VFC-eligible children must be vaccinated regardless of their ability to pay
bull If the person with whom you are conducting the site visit does not know the exact fee charged to non-Medicaid VFC-eligible patients ask to speak to someone who can verify the exact amount
bull If they are charging more than $2122 for the administration fee ndash please contact MDH staff for help with addressing this situation
Resources bull Immunization Billing Guidance for MnVFC (wwwhealthstatemnusdivsidepcimmunizemnvfc billingtipshtml) or Immunization Billing Guidance for MnVFC Replacement Method Sites (www healthstatemnusdivsidepcimmunizemnvfcreplacementbillingtipsrephtml)
bull Section 2 of the MnVFC Policies and Procedures Manual
Page 24 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 3 Documentation Question 31
3 Documentation Eligibility Screening amp Documentation
Question 31 To answer the questions below the provider must clearly demonstrate the patient intake processReview a minimum of 10 records that contain an immunization visit within the last 6 ndash 12 months
Note to Reviewer Criteria for Record Selection 1) Record selection must be completely random and the provider must not know prior to the visit which
records will be reviewed 2) Patient must have been 0-19 years of age at the last visit (Note Records of 19-year-old patients may
allow you to see if VFC vaccines are being used beyond the allowable age) 3) Must review a mix of public and private-pay patients (if applicable)
A Does the provider have a process that ensures that patients are screened forVFC eligibility at each visit and that screening results are documented at each visit
Yes No [X] (If no skip question F)
B Does the providerrsquos process ensure that staff administering vaccine know which vaccine stock to select from prior to drawing the vaccine
Yes No [X]
C Number of records reviewed If fewer than 10 records are reviewed select the reason why Provider does not have 10 patient records with immunizations in last 12 months
D Do all records contain date of the immunization visit and patientrsquos date of birth Yes No [X]
E Do all records contain the patientrsquos specific eligibility status associated with thedate of the immunization
Yes No [X]
F Do any of the providerrsquos records contain any evidence that the patient received vaccine for which they were not eligible
Yes [X] No
Review CDC Requirement
VFC providers must screen for and document VFC eligibility at each immunization visit Documentation must include the date of the visit and the childrsquos specific eligibility category VFC providers must use screening results to ensure that only VFC-eligible children receive VFC vaccine and that administration fees are billed for as appropriate Eligibility status must be readily available to staff administering vaccine prior to selecting which vaccine stock to use
Goal of this question Ensure the site is screening for eligibility and documenting the eligibility category in the medical record
Review a minimum of 10 records from within the last 6-12 months where the patient received an immunization You must review a mix of public and private pay patients (if applicable)
Random selection is important If the staff have pre-selected records for review do not use and identify additional randomly selected records to review
Helpful information bull Discuss upgrading the electronic health record to make documentation of VFC eligibility screening a required field Documenting eligibility screening in the immunization field promotes better MIIC data
bull Q 31 B Sites using the replacement method of vaccine management only have one stock so you will answer ldquoYesrdquo to this question
Resources bull Patient Eligibility Screening Record on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfcformshtml)
bull Section 1 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 25
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 32
3 Documentation Vaccine Dose Documentation
Question 32 Review a minimum of 10 patient immunization records from the last six months (or 12 months ifnecessary) to assess compliance with documentation requirements set forth by Statute 42 US Code 300aa-25 (See note to reviewer below)
Note to Reviewer Criteria for Record Selection 1) Record selection must be completely random the Provider must not know prior to the visit which records
will be reviewed 2) Patient must have been 0-19 years of age at the last visit (Note Records of 19-year-old patients may allow
you to see if VFC vaccines are being used beyond the allowable age)
Records are Compliant if they Contain ALL the Below Elements
bull Address of clinic where vaccine was administered bull Publication date of VIS bull Name of vaccine administered bull Name of vaccine manufacturer bull Date vaccine was administered bull Lot number bull Date VIS was given bull Name and title of person who administered the
vaccine
A Number of records reviewed
B Number of records that contain ALL required documentation elements
If fewer than 10 records are reviewed select the reason why Provider does not have 10 patient records with immunizations in last 12 months
[X] Follow-up isrequired if one ormore records do not meet requirements
Goal of this question Assess whether the site is documenting all required information in each patientrsquos medical record for every vaccine dose administered in accordance with the National Childhood Vaccine Injury Act
Resources bull Section 6 of the MnVFC Policies and Procedures Manual bull National Vaccine Injury Compensation Program (wwwhrsagovvaccinecompensation)
Question 33
3 Documentation Record Retention
Question 33 Is the provider able to demonstrate (preferred) or clearly describe how they maintain historical VFCeligibility documentation for three years
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers are required to maintain all records related to the VFC program for a minimum of three years (or longer if requiredby state law) and upon request make these records available for review VFC records include but are not limited to VFC screening and eligibility documentation billing records medical records that verify receipt of vaccine vaccine ordering records and vaccinepurchase and accountability records
Goal of this question Make sure the site understands they are required to keep all MnVFC screening documentation for at least three years either electronically or on paper This information should be available to you at the time of the visit and future visits
Resource bull Section 7 of the MnVFC Policies and Procedures Manual
Page 26 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 34
3 Documentation Borrowing Documentation
Question 34 Discuss borrowing practices with the provider to answer the questions below
Note to Reviewer bull To be considered ldquofully documentedrdquo documentation for each borrowed dose must include thefollowing information
Vaccine type borrowed Date the dose was administered Stock used (VFC or private) Reason appropriate vaccine stock was not used Patient name and date of birth Date dose was returned to appropriate stock
A Did the provider state that they had borrowed any vaccines (whetherdocumented or not) since the last VFC Compliance Site Visit
Yes No (If no skip to question 36)
B Are there any doses for which there is no documentation (ie provider hasindicated that doses were borrowed but cannot verify how many or why)
All doses are documented Some doses are not documented [X] No doses are documented [X] (if nodoses documented skip toquestion 36)
C Were all borrowed doses fully documented (See Note to Reviewer above) Yes No [X]
D Were all borrowed VFC doses either replaced or an order submitted to replacethe doses Yes No [X]
Review CDC Requirement
VFC providers are expected to maintain an adequate inventory of vaccine for VFC and non-VFC-eligible patients It is theresponsibility of the VFC provider to appropriately schedule and place vaccine orders VFC providers must also rotate stock to ensure timely use of short-dated vaccines Borrowing of vaccine between private and public inventories must be a rare unplanned occurrence and cannot serve as a replacement system for a VFC providerrsquos privately purchased vaccine inventory All instances ofborrowing must be properly documented reported and replaced
Goal of this question Assess vaccine accountability by verifying that children are receiving vaccine from the appropriate stock
Borrowing is when a fully insured child receives a dose of MnVFC vaccine or a MnVFC-eligible child receives a dose of private vaccine This should be a rare unplanned occurrence The site must document any borrowing of vaccine between stocks ideally on the VFC Borrowing Report Form If they are not currently using the form review it with them and encourage them to post it close to their vaccines It does not need to be sent to MDH but should be kept for 3 years and filed with their MnVFC documents to be reviewed whenever they have a regular or unscheduled (unannounced) site visit
Helpful information bull Understand and report on staffrsquos verbal (ie anecdotal) accounts of borrowing obtained during the visit Often sites do not know that what they do is considered borrowing or they think borrowing is acceptable and documentation isnrsquot needed so long as those vaccines are eventually replaced
bull Since sites using the replacement method only have one stock of vaccine they very rarely borrow bull This question asks for future follow-up in 6 months Make a note on your calendar and ask them to send you a copy of their borrowing reports for the previous 6 months with documentation of doses borrowed and replaced We will remind you if we donrsquot hear from you at the 6 month time frame Complete the Follow-up Form and attach the borrowing form
Resources bull Vaccine Borrowing Report on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfc formshtml)
bull Section 10 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 27
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 353 Documentation Borrowing Reasons
Question 35 Based on your discussion with the provider and a review of borrowing reports document the dosesborrowed for each reason and answer the questions below
Note to Reviewer bull Short-dated vaccines are doses that are likely to expire before they can be used bull Exchanging short-dated vaccines should only occur in practices that have a small number of private
patients
A Reasons for Borrowing a VFC Dose (Enter the number of _____ Private vaccine shipment delay (order placed on time but delay in shippingreceipt)
vaccine doses borrowed for each
reason in the spaces
_____ Private vaccine not useable on arrival (vials broken temperature monitor out of range) _____ Ran out of private vaccine between orders (provider orders not placed on time) [X]
provided) _____ Short-dated private dose was exchanged with VFC stock _____ Accidental use of VFC dose for a private patient (human error) _____ Replacement of private dose with VFC when insurance plan did not cover vaccine _____ OtherDocumented dose did not include reason for borrowing [X]
(Explanation Required) Reasons for Borrowing a Private Dose _____ VFC vaccine shipment delay (order placed on time but delay in shippingreceipt) _____ VFC vaccine not useable on arrival (vials broken temperature monitor out of range) _____ Ran out of VFC stock between orders (provider orders not placed on time) [X] _____ Short-dated VFC vaccine dose was exchanged with private dose _____ Accidental use of a private dose for a VFC-eligible patient (human error) _____ OtherDocumented dose did not include reason for borrowing [X]
(Explanation Required)
B Enter date range for instances of borrowing reviewed in the borrowing report Note If ldquoDate of earliest instancerdquo is not available use the date of the last VFC Compliance Visit If ldquoDate of last instancerdquo is not available use the date of thecurrent VFC Compliance Visit
Date of earliest instance
Date of last instance
C Does borrowing appear to be a routine practice Note To determine whether borrowing is a routine practice assess frequency of and repeating reasons for borrowing Examples Frequent accidental use of incorrect stock exchanging short-dated vaccines or issues with ordering and shipment
Yes [X] No
Goal of this question Determine the reasons why the site is borrowing vaccine
If sites are using the Vaccine Borrowing Report review the reasons for borrowing to help document borrowed VFC andor private doses If they have not been documenting borrowing on this report (or any other form) estimate their borrowing practices If you do not know the date range for their borrowing use the last site visit date to the current visit date The use of ldquootherrdquo as the reported reason for borrowing should be rare if ever and would require explanation and follow up
Helpful information bull Look to see if they routinely maintain insufficient amounts or types of vaccine to support their public and private patients that leads to borrowing
bull Pay attention to borrowing cases documented as ldquoaccidentalrdquo Repetitive accidental borrowing may indicate an issue with ordering processes or insufficient staff training
bull Borrowing is not a place to document wasted or lost doses bull The time period of the borrowing may give you clues about the root cause Were the borrowed doses concentrated in a short period or spread out across several months or a year Are all vaccine types being borrowed or just one
bull If borrowing seems to be an issue discuss vaccine management ordering procedures
Resources bull Vaccine Borrowing Report on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfc formshtml)
bull Section 10 in the MnVFC Policies and Procedures Manual
Page 28 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 36
3 Documentation Vaccine Management Plan
Question 36 Physically review the providerrsquos Vaccine Management Plan to answer the question below
A Does the provider have a Vaccine Management Plan Yes No [X] (If no skip to question 37)
B Does the plan list the current Immunization Manager Vaccine Coordinator andback-up
Yes No [X]
C Does the plan address proper vaccine storage and handling practices Yes No [X]
D Does the plan specify vaccine receiving procedures Yes No [X]
E Does the plan contain procedures for what to do with vaccine in the event of an emergency
Yes No [X]
F Does the plan contain procedures for vaccine ordering Yes No [X]
G Does the plan address inventory control (example stock rotation) Yes No [X]
H Does the plan address how to handle vaccine wastage Yes No [X]
I Does the plan address staff training and documentation on vaccine managementstorage amp handling
Yes No [X]
J Does the plan contain a review date that falls within the last 12 months Yes No [X]
K Has the plan been signed by the individual responsible for its content Yes No [X]
Review CDC Requirement
VFC providers must develop maintain and implement a Vaccine Management Plan for routine and emergency vaccinemanagement The plan must contain the current Vaccine Coordinator and back-up proper storage and handling practicesshipping and receiving procedures emergency procedures procedures for vaccine ordering inventory control (eg stock rotation)how to handle vaccine wastage and staff trainingdocumentation on vaccine management storage and handling The plan must bereviewedupdated annually or more frequently if changes occur A ldquoreview daterdquo and signature are required on all plans in order tovalidate that they are current
Goal of this question Evaluate the sitersquos plan for vaccine management It is especially important that they have a plan for emergency management of their vaccine in the case of equipment failure or power outage Encourage all sites to read and sign the MnVFC Policies and Procedures Manual and complete the emergency plan or be able to show you a plan of their own
If the provider is not able to physically show you the plan at the time of the visit or if the recorded review date is not within the last 12 months you must mark that this requirement is unmet The Vaccine Management Plan is important in times of emergency and it should be easy to access by any staff member at any time Encourage them to post the plan and put a copy with the packing supplies
Helpful information bull Encourage the site to fill in the ldquoImmunization Managerrdquo and ldquoVaccine Coordinatorrdquo fields in the
MnVFC Policies and Procedures Manual for their own referencebull The emergency plan in the manual can be reviewed from last year and included in this yearrsquos manual (with an updated signature and date) if there have not been any changes
bull If information in the plan is outdated site staff will not be well equipped to safely manage vaccines in the event of a power-outage or other emergency situation
bull If their institutional policy is only reviewed and updated every 3-4 years (as many are) the staff may need to sign the MnVFC Polices and Procedure Manual to meet this requirement
Resource Routine Vaccine Management Plan and Emergency Vaccine Management Plan in the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 29
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 37
3 Documentation VIS amp VAERS
Question 37 Review the providerrsquos Vaccine Information Statements (VISs) and discuss providerrsquos VAERS process toanswer the questions below
A Does the provider have readily available up-to-date VISs for all ACIP-recommendedvaccines relevant to the populations it serves
Yes No [X]
B Does the provider make a VIS available for patientsparents before eachvaccination
Yes No [X]
C Does the provider know how and when to report clinically significant adverseevents using VAERS
Yes No [X]
Review CDC Requirement
VFC providers are required to distribute the current Vaccine Information Statements (VIS) each time a vaccine is administered and maintain records in accordance with the National Childhood Vaccine Injury Act (NCVIA) which includes reporting clinicallysignificant adverse events to the Vaccine Adverse Event Reporting System (VAERS) For a list of current VISs visit CDCrsquos Vaccine Information Statements (httpwwwcdcgovvaccineshcpvis) website
Gal of this question Ensure the site has the most current VISs and is giving them to each patientparent before administering the vaccine in compliance with the federal law Parents must be educated about the vaccine their child will receive and be aware of possible contraindications and side-effects in order to make well-informed decisions about their childrsquos health
Helpful information bull Ask to see the sitersquos VISs to determine if they have an active protocol for giving VISs to parents Review to make sure they are current Ask if they know where and how to report vaccine adverse events
Resources bull Section 3 in the MnVFC Policies and Procedures Manual bull CDC Vaccine Information Statements (wwwcdcgovvaccineshcpvisindexhtml) Site may sign up for email updates for the current list of VIS publication dates for the most up-to-date version
bull IAC Itrsquos Federal Law You must give your patients current Vaccine Information Statements (wwwimmunizeorgcatgdp2027pdf)
bull VAERS (httpsvaershhsgovindex)
Question 38
3 Documentation Anaphylaxis protocol
Question 38 Does the site have an anaphylaxis protocol which is clearly posted near the emergency kit
Answers (Choose one)
Yes No [X]
Review CDC Requirement
An anaphylaxis protocol must be clearly posted in the area where vaccines are administered
Goal of this question Make sure site is prepared for a severe allergic or anaphylactic reaction to a vaccine
Resources bull Section 11 in the MnVFC Policies and Procedures Manual bull IAC protocols Child and Teens (wwwimmunizeorgcatgdp3082apdf) and Adults (wwwimmunize orgcatgdp3082pdf)
Page 30 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
i
i i i - li i i i i i l
Section 4 Storage amp Handling Per Unit The goal of this section is to assess vaccine storage
2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet practices in each unit at the site MnVFC PIN ___________________
The 2017 MnVFC Storage amp Handling Per Unit Answer Sheet is a worksheet to document the answers to the questions in this section for each unit (combination or stand-alone) Fill in the answers to the questions in Section 4 on the answer sheet not in the questionnaire
The answer sheet has an abbreviated form of each question If you need further information on that question refer back to the full questionnaire Also if you find an area where the site is not meeting the requirements you will need to go back to that question on the 2017 MnVFC Site Visit Questionnaire to complete ldquoActions if Non- compliantrdquo section including the root cause analysis and follow-up sections If there is a problem in more than one unit make a note on the questionnaire which unit you are referring to in the Notes section
Important You must fully assess any unit that may be used to store VFC vaccines even if there are no VFC vaccines there on the day of the visit If there are no vaccines and the site is not documenting twice a day temperatures discuss the need to ensure the unit is maintaining stable temperatures by monitoring for one week before placing vaccines in the unit
Quest on number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
for the freezer and e co umn
Temperature Monitoring Dev refr gerator f the un
ce Quest ons Quest ons 4 3 4 7 must be answered separate y t s a combo Be sure to document responses n the appropr at
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
44D Data downloaded and reviewed routinely (eg weekly)
Yes No [O]
Yes No [O]
45A Certificate of Calibration Testing Yes No [X]
Yes No [X]
45B Date of calibration
45C Date certificate expires [X] Follow-up is required if expired [X] Follow-up is required if expired
45D Certificate contains all necessary items
Yes No [X]
Yes No [X]
46 Probe properly placed Yes No [X]
Yes No [X]
47A Two temperature readings per day
Yes No [X]
Yes No [X]
47B Time date and name (or initials) for each reading
Yes No [X]
Yes No [X]
47C Current temperature and minmax temperatures (if
Current ________deg Minimum ________deg Maximum _deg
Current ________deg Minimum ________deg Maximum _deg
Sections 5 and 6 contain questions about storage and handling site wide and inventory It is helpful to keep those questions in mind as you assess the individual storage units Think about dorm-style units expired vaccine vaccine supply room for vaccine stocking all the recommended vaccines and separation of stock if appropriate
NOTE The sections that follow require reviewers to validate responses by looking at vaccine storage units temperaturemonitoring equipment and the vaccine inventory inside a unit bull For section 4 use a separate Storage amp Handling Per Unit Answer Sheet for each unit to document the findings (combination
units using both sections can be documented on the same answer sheet) bull When an unmet requirement is identified return to this questionnaire to complete the ldquoActions if Non-compliantrdquo section for
that question bull After you complete one answer sheet for each unit return to the questionnaire to complete sections 5 and 6 using information
you gathered while assessing the units The questions in sections 5 and 6 (Storage amp Handling Site-Wide and Inventory) are notunit-specific but do require that the response be based on a thorough assessment of all the providersrsquo units
4 Storage amp Handling Per Unit
Description On the Storage amp Handling Per Unit Answer Sheet place a name that will allow you or someone else from your program to easily identify this unit in the event of follow-up We recommend using Brand + Location(example Samsung - Room 123) Save each Storage amp Handling Per Unit Answer Sheet with the Brand + Location in the file name
(example SamsungRoom123doc)
IPI Advisor Manual | February 2017 Page 31
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 41
4 Storage amp Handling Per Unit Storage Unit Build amp Use
Question 41 Below select the build and use of the vaccine storage unit you are assessing
Note to Reviewer Dorm-style units Do not add dorm-style units here Dorm-style units will be addressed in section 5 Units storing only private stock You must review these storage units even if they contain only private stockat the time of the visit because that vaccine could be administered to VFC patients
A What type of unit is this A Stand-alone B Combination
B Select use if stand-alone A Freezer B Refrigerator
Select use if combination A Use both sections to store vaccine B Use freezer section only to store vaccine C Use refrigerator section only to store vaccine
Goal of this question Identify the unit you are evaluating The description asks you to create a unique name for this unit so that you will be able to identify the same unit in future site visits Put this description on the top of the answer sheet (ie make and location)
Helpful information bull A stand-alone unit is either a refrigerator or a freezer It does not have both sections in the unit bull If there is a combination unit note if the site uses both the refrigerator and freezer or only one section of the unit to store vaccines CDC does not recommend the use of either section or the freezer section only of combination household units
bull If your site utilizes the separate stock method of vaccine management you must review storage units even if they contain only private stock at the time of the visit because there is a chance that those vaccines could be administered (borrowed) to VFC-eligible patients
Page 32 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 424 Storage amp Handling Per Unit CDC Recommended Storage Units
Question 42 Below document the grade of the vaccine storage unit you are assessing
Note to Reviewer Pharmaceutical Also called ldquopurpose-builtrdquo these units are designed by the manufacturer specifically tostore vaccines or other biological materials Commercial Although usually intended to store food and beverages commercial units are often larger and more powerful than the household units found in most homes Though these units are intended to meet thehigher demands of larger facilities these units are not specifically built for the storage of biologicalmaterials Household (non-commercialdomestic) These units are usually smaller than commercial units and areintended for use in small offices and in homes ndash typically for food storage However just like commercialunits they are not designed specifically for the storage of biological materials Such units are usually available in common home supply stores
Answers (Choose one)
Select grade A Pharmaceutical B CommercialHousehold
[O] CDC does not recommend the use of both sections or the freezer section only of combination commercialhousehold units
Review CDC Recommendation
CDC recommends the following vaccine storage unit types (in order of preference) pharmaceutical grade stand-alone orcombination units (preferred) householdcommercial stand-alone units householdcommercial combination units using therefrigerator section only
Goal of this question Assess the grade and type of each storage unit bull Pharmaceutical grade units may be stand-alone or combination units that are often metal may have glass in the door for viewing inside often have an external digital temperature display and are manufactured by medical companies
bull Commercial or household units often look like your kitchen appliance have vegetablemeat drawers in the unit and are manufactured by household appliance companies
bull Occasionally you might find a medical grade unit which is usually a commercialhousehold unit with a lock and 3-prong plug These are still considered household units because of their ability to maintain proper temperatures and air flow Studies show that household stand-alone units are better able to maintain consistent temperatures than their combination counterparts Combination household units used to store vaccine in both sections of the unit is no longer recommended and may be prohibited in the future Combination household storage units that are having difficulty maintaining a cold enough freezer temperature and a warm enough refrigerator temperature should be replaced or a separate stand-alone freezer should be purchased
For frozen vaccines the most cost effective solution is for the site to purchase a small stand-alone freezer The site may need time to budget for a stand-alone storage unit
Resources bull Replacing Combination Household Units Tip Sheet on IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml)
IPI Advisor Manual | February 2017 Page 33
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 434 Storage amp Handling Per Unit Temperature Monitoring Device in the Unit
Question 43 Determine whether there is a temperature monitoring device in this section of the storage unit andanswer the questions
A Is there a temperature monitoring device in this section of thestorage unit
Yes No [X] (If no skip to question 47)
B Who is responsible for supplying the temperature monitoring device in this section of the storage unit Provider
Review CDC Requirement
Certificates of calibration testing provide confidence that the temperature monitoring device is measuring temperaturesaccurately All units storing VFC vaccines must have a calibrated temperature monitoring device with a current and valid certificateof calibration testing All certificates must contain modeldevice name or number serial number date of calibration testing (report or issue date) and Instrument Passed testingInstrument in Tolerance (Recommended uncertainty = +-05ordm C (+-1ordm F))
Goal of this question Assess whether there is a temperature monitoring device in the unit If the unit is not being monitored at all call MDH at 651-201-5522 for guidance
Helpful information bull This question does not ask whether the temperature monitoring device is working or the characteristics of the device These issues will be addressed later in the questionnaire
bull For part B the provider is always responsible for supplying the temperature monitoring device Even if their thermometer or data logger was originally from MDH it is their responsibility to ensure it is functional and calibrated
Resources bull Section 8 in the MnVFC Policies and Procedures Manual
Page 34 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 444 Storage amp Handling Per Unit CDC Recommended Temperature Monitoring Device
Question 44 Assess the temperature monitoring device in this section of the storage unit to answer the questionsbelow
A Is the temperature monitoring device a continuous monitoring and recordingdevice (eg data logger)
Yes No [O] (Skip D)
B Does the temperature monitoring device have a probe in buffered material Yes No [O]
C Does the temperature monitoring device have a digital display that can beeasily read from the outside of this unit
Yes No [O]
D Is data downloaded and reviewed routinely Yes No [O]
Review CDC Recommendation
As of Jan 1 2018 all VFC providers must use continuous temperature monitoring devices (eg data loggers) to monitor vaccinesthat will be administered to VFC-eligible children Routine review and accessibility of temperature data is critical for determining whether vaccine has been properly stored and for assessing usability of vaccine that was involved in a temperature excursion Tomeet VFC Program requirements the device must also be equipped with bull A temperature probe bull An active temperature display that can be easily read from the outside of the unit bull The capacity for continuous monitoring and recording capabilities where the data can be routinely downloaded
The following are additional recommended features for these devices bull Alarm for out-of-range temperatures bull Current minimum and maximum temperatures display bull Low battery indicator bull Accuracy of +- 1degF (05degC) bull Memory storage of at least 4000 readings bull User programmable logging interval (or reading rate) recommended at a maximum time interval of every 30 minutes bull Use of a probe that best reflects the temperature of the vaccine (such as a buffered probe)
Goal of this question Assess the temperature monitoring device in the storage unit Note that these are all recommendations not requirements at this time
This is a great teaching opportunity for sites who do not currently have a continuous temperature monitoring device Beginning Jan 1 2018 all units that store MnVFC vaccine will be required to have a continuous temperature monitoring device (ie a data logger or a continuous temperature monitoring system) Unlike a minmax thermometer a continuous temperature monitoring device provides detailed information on all temperatures recorded at pre-set intervals For excursions it can provide information on when a temperature went out-of-range for how long and what the temperatures were This is essential information that vaccine manufacturers need to know to assess the viability of the vaccine following an excursion
Helpful information bull Sites are required to monitor and record temperatures twice daily however temperature excursions can easily occur in the 12 hours or longer between readings Continuous temperature monitoring can help manufacturers determine vaccine viability
bull Continue to encourage sites to document and evaluate minimum and maximum temperatures the storage unit reached since the last reading and respond appropriately to out-of-range temperatures
IPI Advisor Manual | February 2017 Page 35
The 2017 MnVFC Site Visit Paperwork Chapter 4
bull It is recommended that sites download and review data weekly Discuss with sites that reviewing temperature monitoring device data also includes responding appropriately if they identify out-of-range temps
bull There is sometimes confusion about the difference between a data logger and a continuous temperature monitoring system Here are some differences
Data Loggers Continuous Monitoring Systems Have an external display similar to thermometers May or may not have an external display Have a detachable probe Probe is usually attached to transmitter Need to be plugged into the computer or cradle to download information on a regular schedule
Wirelessly sends data to computer system
Create a file of data that needs to be saved on the computer
Data is stored within the system not a separate file
Doesnrsquot allow documentation of twice a day temperature checks in the file
May allow documentation of twice a day temperature checks within the system
More about the 2018 requirement for a continuous temperature monitoring device
Required Features bull The continuous temperature monitoring device must have Continuous monitoring and recording capabilities to track and record temperatures over time The capacity to routinely download temperature data to a computer (recommended at least weekly) or wirelessly transmit data Detachable probe in a bottle filled with a thermal buffer (eg bio-safe glycol) if the data logger needs to be detached in order to download data Active temperature display
Recommended Features bull MnVFC recommends continuous temperature monitoring devices with Alarm for out-of-range temperatures Accuracy within +-1degF (+- 05degC) Low battery indicator Display of current minimum and maximum temperatures Memory storage of at least 4000 readings User programmable logging intervals (eg the user can set how often the device records the temperature)
Note that these are all currently recommendations not requirements yet
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Page 36 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 45
Goal of this question Ensure the temperature monitoring device is properly calibrated The certificate of calibration testing means that the device has been tested and it is accurately measuring temperatures within established testing limits The certificate of calibration ensures that the device meets all the required components
Helpful information bull The provider is always responsible for having a current certificate of calibration (or copy) on-site
bull To be considered ldquovalidrdquo a certificate of calibration must contain these required elements Modeldevice name or number Serial number
4 Storage amp Handling Per Unit Certificate of Calibration Testing
Review CDC Requirement
Certificates of calibration testing provide confidence that the temperature monitoring device is measuring temperaturesaccurately All units storing VFC vaccines must have a calibrated temperature monitoring device with a current and valid certificateof calibration testing All certificates must contain modeldevice name or number serial number date of calibration testing (report or issue date) and Instrument Passed testingInstrument in Tolerance (Recommended uncertainty = +-05ordm C (+-1ordm F))
Question 45
Note to Reviewer
A
B
C
D
E
Review the certificate of calibration testing for the temperature monitoring device in this section of the storage unit and answer the questions below
bull How to determine certificate of calibration testing expiration date 1) Identify the certificate issuecalibration date 2) Apply the Immunization Program-required frequency for calibration testing Example If the
issuecalibration date is 12312013 and Immunization Program policy requires testing every twoyears the expiration date is 12312015
bull Certificates must include all of the below bull ModelDevice Name or Number bull Serial Number bull Date of Calibration Testing (Report or Issue Date) bull Instrument Passed testing (Instrument in Tolerance)
Is there a certificate of calibration testing for the temperature monitoring Yes device in this section of the storage unit No [X]
What is the date of calibration for the temperature monitoring device in this section of the storage unit
What is the certificatersquos date of expiration based on ImmunizationProgram policy (See note to reviewer to determine expiration date) [X] Follow-up is required if
certificate is expired
Does the certificate contain all the necessary items listed in the Note to Yes Reviewer No [X]
Who is responsible for supplying the current and valid certificate of Provider calibration for this temperature monitoring device
Date of calibration testing (report or issue date) Note If there is no expiration date the certificate expires 2 years from the date of calibration Whether the instrument passed or failed testing (or instrument in tolerancenot in tolerance)
bull Recommended element Documented uncertainty of +- 1degF [05degC]
If these elements are present the certificate is considered valid If the certificate contains information about the recommended element or the entity that issued the certificate that is helpful but not required
To determine if a certificate of calibration testing was issued by an appropriate entity check to see if the certificate indicates one or more of these items (this is the wording used to help sites evaluate if their calibration is accurate but is not required on the certificate itself to be considered valid)
bull Conforms to ISO 17025 bull Performed by an ILACMRA Signatory body accredited laboratory You can review this list of the ILAC MRA and Signatories (httpilacorgilac-mra-and-signatories)
bull Traceable to the standards maintained by NIST bull Meets specifications and testing requirements for the American Society for Testing and Materials (ASTM) Standard E2877 tolerance Class F (le 05 degC) or better
bull Includes reference to another acceptable accuracy validation method such as comparison to other traceable reference standards or tests at thermometric fixed points
Note CDC recommends that certifications be issued for the entire monitoring unit (detachable probe data logger etc) and not individual certificates for each component
IPI Advisor Manual | February 2017 Page 37
The 2017 MnVFC Site Visit Paperwork Chapter 4
For 45 E the provider is always responsible for supplying the current and valid certificate of calibration for a temperature monitoring device
bull Tip If the temperature monitoring device has a sticker on the back with the calibration date the site can usually call the company who calibrated the device and get a copy of the certificate if they donrsquot have one
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 46 4 Storage amp Handling Per Unit Probe Placement
Question 46 Is the probe properly placed in this section of the storage unit
Note to Reviewer ldquoProperlyrdquo means that the probe in a commercial or household unit is placed in a central area of the unitdirectly with the vaccines Probes should not be placed in the doors near or against the walls close to vents or on the floor of the unit The only allowable exemption related to this requirement is for providerswho have pharmaceutical storage units (built for vaccine storage) that have either (1) a built-intemperature monitoring device OR (2) a dedicated port for the probe that dictates the placement of theprobe
Answers (Choose one)
Yes No [X]
Review CDC Requirement
The probe must be placed in a central area of the section of the storage unit directly with the vaccines in order to properly measurevaccine temperature The probe should not be placed in the door near or against the walls close to vents or on the floor of theunit For pharmaceutical units with a built-in temperature monitoring device or a dedicated port for a probe that is not in thecenter of the section of the storage unit consult your Immunization Program for guidance on placement
Goal of this question Make sure the temperature monitoring device is in the best location to accurately measure the temperature of the vaccines stored in the unit
Helpful information bull The probe of the temperature monitoring device should be placed directly with the vaccines in the middle of the unit The ONLY allowable exception is for pharmaceutical storage units that have either a built-in thermometer or a dedicated port for the probe that indicates placement of the probe
bull Temperatures can vary within the unit especially household units bull Call MDH at 651-201-5522 if you have questions
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Guide (wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml)
Page 38 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 474 Storage amp Handling Per Unit Temperature Documentation
Question 47 Review the temperature documentation over the past three months for this section of the storage unit todetermine whether the provider has a process in place for properly documenting temperatures twice aday Answer the questions below
A Are there two temperature readings recorded for this section of the storage unit per day
Yes No [X]
B Is there a time date and name (or initials) recorded for each reading Yes No [X]
C What is the current temperature and minmax temperatures (if available) inthis section of the storage unit Use the reviewerrsquos thermometer if the providerrsquos temperature monitoringdevice does not have a current valid certificate of calibration testing or the probe is not properly placed in this section of the storage unit
Current Temperature Minimum Temperature Maximum Temperature Fahrenheit Celsius
D Based on your review of the providerrsquos recent temperature documentationincluding the current temperature is this section of the storage unitmaintaining appropriate temperatures
Yes No [X] Not enough information [X]
Review CDC Requirement
Vaccines must be stored under appropriate temperatures as described in the package inserts at all times Acceptable temperature ranges vary by vaccine type and the range is 36deg F and 46deg F (2deg C and 8deg C) and for frozen vaccines the range is -58deg F and +5deg F (shy50deg C and -15deg C) Exposure to temperatures outside of those included in the package inserts could affect vaccine viability andultimately could leave children unprotected against vaccine-preventable diseases In order to maintain awareness of storage unittemperatures and ensure that vaccines are being stored at appropriate temperatures at all times VFC providers are required to monitor and document temperatures for all vaccine storage units at least twice a day Temperature documentation must contain (1) at least two temperature readings per day (2) the time and date of each reading and (3) the name (or initials) of the personwho assessed and recorded the readings CDC also recommends that VFC providers record the minimum and maximumtemperatures of each unit once each workday (preferably in the morning)
Goal of this question Ensure the temperature is being monitored twice daily is within the required range and documented correctly Use your thermometer to check the temperature if the sitersquos temperature monitoring devicersquos probe is not properly placed or there is not a current certificate of calibration Place your thermometer in the unit at the beginning of the visit to allow sufficient time to reach an accurate temperature The purpose of using your thermometer is to ensure the vaccine is being stored at the proper temperature not to ldquovalidaterdquo their reading
Question 47 D is an assessment question based on information you have learned during your visit You might answer ldquonot enough informationrdquo if the unit is new and they donrsquot have at least three months of data or if the unit is only used as overflow and they are inconsistent with temperature monitoring Mark ldquoNordquo if you have reason to believe the storage unit is not maintaining temperatures properly
Helpful information bull All sites must document temperatures twice a day every day the site is open even if they have a data logger or continuous monitoring system
bull Sites can document the information electronically with some continuous monitoring systems as long as it can show what the current temp is the date time and initials of the person checking ndash this needs to be someone at the site ndash not checking remotely or centrally for a large site or system The site must be able to produce these records during their site visit Reviewing these files can be a challenge due to large volumes and lots of paper
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Temperature Logs on Managing Vaccine (wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml)
IPI Advisor Manual | February 2017 Page 39
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 484 Storage amp Handling Per Unit Temperature Excursions
Question 48 In the event that a temperature excursion(s) occurred in this unit within the last three months requestand review documentation of actions taken to determine whether the provider has a process for properlyaddressing excursions Answer the questions below
A Were vaccines in this unit exposed to out-of-range temperatures in the lastthree months (including today)
Yes No (If no skip to question 49)
B Did the provider quarantine and label vaccines as ldquoDo not userdquo Yes No [X]
C Did the provider place vaccine in a unit where it can be stored under properconditions if applicable
Yes No [X]
D Did the provider contact the Immunization Program to report theexcursion
Yes No [X]
E Was the manufacturer contacted for documentation supporting theusability of the vaccine
Yes No [X]
Review CDC Requirement
The provider must document all excursions and actions taken including the following (1) Quarantine and label vaccines as ldquoDO NOTUSErdquo (2) Place vaccines in a unit where they can be stored under proper conditions (3) Contact the Immunization Program to report an excursion and (4) Contact the vaccine manufacturer to obtain documentation supporting the usability of the vaccine
Goal of this question Address any out-of-range temperatures (temperature excursions) identified in reviewing the last three months of temperature logs or during the site visit If there were any out-of-range temperatures did the site respond appropriately to the situation This is a great opportunity to discuss what to do in the event of an excursion The Clinicians Storage and Handling Mishap Checklist is in the IPI Site Visit information folder and is a good review of the process
Helpful information bull Sites need to know that an excursion does not automatically mean that exposed vaccines are non-viable or unusable Exposed vaccines must be quarantined (marked ldquoDo Not Userdquo) and stored under proper conditions until they have received information from vaccine manufacturers regarding the viability of the vaccine
bull Sites must inform MDH when an excursion occurs
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Clinicians Storage and Handling Mishap Checklist (wwwhealthstatemnusdivsidepcimmunize ipivaxchklstpdf)
Page 40 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 49
Goal of this question Ensure proper placement of vaccines in the storage unit
Note These are all recommendations (best practices) not requirements
Helpful information bull Store vaccine in the middle of the compartment two to three inches away from the coils walls floor and cold air vent The temperature near the floor and walls of the unit differs from that in the middle of the compartment and the cold air vent can freeze refrigerated vaccines
4 Storage amp Handling Per Unit Vaccine Placement
Question 49 Look inside the unit to answer the questions below
A Are vaccines placed in the middle of the unit with space between vaccinesand the sideback of the unit to allow cold air to circulate
Yes No [O]
B Are vaccines stored in their original packages Yes No [O]
C Are there water bottles (for refrigerators) or frozen water bottles (forfreezers) in the unit
Yes No [O]
D Are vaccines store in the doors vegetable bins under or near cooling ventsor on the floor of the unit
Yes [O] No
E Is food being stored in the unit Yes [O] No
Review CDC Recommendation
Vaccines should be stored in their original manufacturer (or CDC centralized distributor) packaging They should be placed in the middle of the unit with space between the vaccines and the sideback of the unit to allow cold air to circulate Vaccines SHOULD NOT be stored in the doors vegetable bins or floor of the unit or under or near cooling vents and there should not be any food inthe unit Water bottles (for refrigerators) or frozen water bottles (for freezers) should be placed throughout each storage unit inorder to (1) stabilize or extend temperatures during a power outage and (2) to serve as physical blocks preventing the placementof vaccines in areas of the unit that are at higher risk for temperature excursions (such as in doors vegetable bins floor ornearunder cooling vents)
bull Vaccines should be kept in their original packaging to Protect them from light Help prevent medication errors by making labels easier to read Provide a moisture barrier that serves as insulation in case of an out-of-range temperature power outage door left open or mechanical failure Simplify managing vaccine inventory
bull Store water bottles in the doors on the floor and near the cold air vent in the refrigerator and frozen water bottles in the freezer to help maintain a stable temperature if there is a power failure and when the door is opened frequently Too many water bottles in the door can prevent the door from closing tightly Mark water bottles ldquoDo Not Drinkrdquo
bull Do not store vaccine in the door or drawers of the refrigerator or freezer Vegetable bins and crisper drawers should be removed from refrigerators or used to store other medical supplies or water bottles
bull If vaccine is stored in a household combination refrigeratorfreezer The top shelf should not be used for storing vaccine because the cold air vent blowing from the freezer will freeze vaccine located there If you must use the top shelf of this type of unit place water bottles underneath the cold air vent to prevent vaccine from being stored there It is recommended that only the refrigerator be used for vaccine storage and a separate stand-alone freezer be used to store frozen vaccine
bull Must not store food or beverages in the refrigerator or freezer because frequent opening of doors can lead to temperature variations that may affect vaccine viability There is also a risk of contaminating vaccines
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Guide (wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml) bull Vaccine Storage Tip Sheet on IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml)
IPI Advisor Manual | February 2017 Page 41
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 4104 Storage amp Handling Per Unit Disconnection from Power Source
Question 410 Ask the provider to demonstrate what measures are taken to ensure that vaccine storage units are notaccidentally physically disconnected from the power supply Which of the following describes the measure(s) taken on this unit
Note to Reviewer bull Large hospitals and healthcare systems may not have the ability to demonstrate labels on plugs or circuitbreakers In such cases verify that the practice has a comprehensive policy and standard operatingprocedures in place to prevent the vaccine storage unit from being physically disconnected from thepower supply
bull While back-up generators may ensure power to the overall facility this question ONLY addresses thevaccine storage unit being accidentally disconnected from the power source either through the plug orthe circuit breaker
Answers A ldquoDo not disconnectrdquo labels on the plug (Choose all that B ldquoWarningrdquo label on the circuit breaker box
apply) C Hard-wired (ie built-in) and has a ldquoDo not disconnectrdquo label on thecircuit breaker box D Hospital or large health care system with a comprehensive written policyand standard operating procedures detailing measures taken to preventvaccine storage units from being accidentally disconnected from the powersupply E No acceptable measures for preventing accidental disconnection frompower supply [X]
[X] The response is non-compliant if only A only B or E is selected
Review CDC Requirement
VFC providers must take steps to protect the power source for all vaccine storage equipment by means of having clear warninglabels on both the plug and the circuit breaker associated with all vaccine storage units Large hospitals and healthcare systems canmeet this requirement by demonstrating that they have comprehensive policies and standard operating procedures to preventvaccine storage units from being physically disconnected from the power supply
Goal of this question Decrease the chance that a vaccine storage unit will be accidently unplugged or power will be turned off while vaccine is in the unit This question addresses only what measures the site has taken to ensure the storage unit is not physically disconnected from its power source
If the site uses labels on the plugs and circuit breakers perform a visual inspection to assess whether the way the stickers are positioned make it clear and obvious to anyone that these units are not to be disconnected
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Do Not Unplug and Warning stickers are included in the folder or available to order on the For
Professionals Order Form (wwwhealthstatemnusdivsidepcimmunizeordermathtml)
Note Once you have completed the 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet for each unit return to the questionnaire to complete sections 5 and 6
Page 42 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
- -
Section 5 Storage amp Handling Site-Wide Question 51
5 Storage amp Handling Site Wide Discussion of Cost amp Quantity of Vaccine
Question 51 Have a discussion with the provider about the cost and quantity of VFC vaccines they are responsible for annually Address the points listed in the note to reviewer below
Note to Reviewer bull Vaccine Shipped (Required) Share the cost of VFC vaccines shipped to the provider in the last calendaryear to make sure the provider understands the contribution made by the VFC Program to their practiceFor new providers who do not have ldquocalendar yearrdquo data share either the actual cost of their currentinventory or use the cost of 10 VFC doses of each of the ACIP-recommended vaccines (approximately $7000) to help estimate their annual cost
bull Storage amp Handling (Required) Make sure the provider understands the cost of vaccines for which they are responsible when they make decisions about purchasing recommended vaccine storage and temperature monitoring equipment
Answer I have discussed with the provider the cost and quantity of vaccines ordered in the previous calendar year
Goal of this question Inform sites of the quantity and value of vaccines that they receive as part of the MnVFC program Providers often donrsquot realize the value of the vaccine in their unit This information is included on your clinic list and on the one page site-specific information
Helpful information bull This discussion must occur and the box on the questionnaire must be checked bull If there isnrsquot actual vaccine value information available tell the site that one vaccine order that includes a box of each of the ACIP recommended vaccines costs approximately $7000
bull MDH may not have specific information for individual sites if they receive vaccine from a central warehouse or pharmacy For those sites MDH will give you numbers for the whole system so you can discuss system wide data as appropriate If individual site information is also included it is usually just varicella-containing vaccines that must be shipped directly to the site
Question 52
5 Storage amp Handling Site Wide Dorm Style Units
Question 52 Determine whether the provider has any dorm-style units on site and answer the questions below
Note to Reviewer A dormitory-style refrigerator is a unit that has both refrigerator and freezer compartments behind a singleexterior door Dorm-style units also have an evaporator plate (cooling coil) which is usually located insidean icemaker compartment (freezer) within the refrigerator
A Does the provider have any dorm-style units that are used at any time tostore vaccines
Yes [X] No (Skip to question 53)
B Does the provider have sufficient space in existing compliant vaccinestorage units to store all vaccines without use of the dorm-style unit at any time
Yes No [X]
Review CDC Requirement
Dorm- and bar-style units are prohibited for vaccine storage Vaccines stored in dorm-style units are considered non-viable and must be returned to the centralized distributor CDC recommends the following vaccine storage unit types (in order of preference)pharmaceutical grade stand-alone or combination units (preferred) householdcommercial stand-alone unitshouseholdcommercial combination units using the refrigerator section only
Goal of this question Ensure no vaccine is stored in dorm-style units even for short periods of time Encourage them to label any units ldquoNo Vaccine Storage Allowedrdquo Vaccine stored in these units is considered non-viable If a site is using a dorm-style unit call the MnVFC program (651-201-5522)
Resource Section 8 in the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 43
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 535 Storage amp Handling Site Wide Storage Unit Space Availability
Question 53 Does the provider have sufficient room across storage units to store current stock as well as anyadditional stock acquired during peak season without overcrowding
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have sufficient storage space to accommodate vaccine stock at the busiest time of year without overcrowding
Goal of this question Ensure that sites have sufficient space in their units to maintain vaccines at the busiest time of year Overcrowding of vaccine limits air circulation and affects the unitrsquos ability to maintain stable temperatures
Helpful information bull Look for signs of overcrowding such as vaccines that are pushed up against the wall bins that are overflowing or storage units that are full during non-peak seasons
Discuss immediate actions if the unit is overcrowded Move some of their vaccines order less vaccine more frequently (once per month preferably) andor purchase another storage unit for overflow
Resource bull Section 8 MnVFC Policy and Procedure Manual
Page 44 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 545 Storage amp Handling Site Wide Expired Vaccines
Question 54 Look in each unit Are there expired vaccines in any of the vaccine storage units at this site
Answers (Choose one)
Yes [X] No
Review CDC Requirement
Vaccines should be rotated weekly and when a new shipment comes in so that longer-dated vaccines are stored behind shorter-dated vaccines If vaccines expire they can no longer be stored in the same storage unit with viable vaccines They must be placedin a container or bag clearly labeled ldquoDo not userdquo and separated from viable vaccines to prevent inadvertent use Expired vaccinemust be returned to the centralized distributor within six months of expiration
Goal of this question Ensure there is no expired vaccine in any storage unit
Helpful information bull Sites can prevent their stock from expiring by rotating vaccines every week andor when a new shipment arrives Longer-dated vaccines are stored towards the back of the unit and shorter-dated vaccines are up front
bull Pay attention to vaccines that expire within the next three months Consider transferring vaccine that will expire soon to another MnVFC-enrolled site that will use the vaccine preferably a site close by It is the transferring sitersquos responsibility to arrange the transfer of the vaccine Be sure to complete the MDH Vaccine Transfer Record form and send it to MDH If they are having difficulty finding a location to accept vaccine contact MDH
bull This is a great opportunity to educate sites about the MDH Nonviable Vaccine Form and the process for returning vaccine The VFC program does get some credit for taxes and fees on vaccine that is returned to the distribution center
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MDH Nonviable Vaccine Form and MDH Vaccine Transfer Record on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfcformshtml)
IPI Advisor Manual | February 2017 Page 45
The 2017 MnVFC Site Visit Paperwork Chapter 4
- -
-
Question 555 Storage amp Handling Site Wide Back up Thermometer
Question 55 Does the provider have a readily available back-up thermometer with a current and valid certificate ofcalibration testing
Note to Reviewer ldquoReadily availablerdquo means that the thermometer is available to perform twice-a-day monitoring for a unit asrequired CDC recommends that the back-up thermometer be maintained on site
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have a readily available back-up thermometer with a current and valid certificate of calibration testing Toprevent the certificates of calibration testing of the primary and back-up thermometers from expiring at the same time the date of calibration testing (or issue date) of the back-up thermometer should be different from the date of calibration testing (or issue date) of the primary thermometer As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meetsVFC program requirements
Goal of this question Ensure sites have one calibrated back-up thermometer onsite that is readily available in the event that the temperature monitoring device in unit fails transportation of vaccine is needed or there are other unexpected circumstances
Helpful information bull As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meets VFC Program requirements
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 56 5 Storage amp Handling Site Wide Preparation of Vaccine
Question 56 When does this provider prepare vaccine for administration to the patient
Note to Reviewer For mass vaccination clinics if one type of vaccine is offered providers may pre-draw up to 10 doses Ifusing pre-filled syringes pre-drawing also means activating the syringe by removing the needle guard orattaching a needle
Answers (Choose all that
apply)
Prepare dose immediately before administration Pre-draw doses for upcoming patients (in a regular clinicpractice) [O] Pre-draw up to 10 doses (in a mass-vaccination clinic) Pre-draw more than 10 doses (in a mass-vaccination clinic) [O] Other [O]
Review CDC Recommendation
CDC recommends preparing vaccines immediately prior to administration in order to assure viability of vaccine and prevent vaccinewastage Vaccines that are not administered immediately are at risk of exposure to temperatures outside of the required rangewhich can affect vaccine viability and ultimately can leave children unprotected against vaccine-preventable diseases
Goal of this question Discuss proper timing and preparation of vaccine(s) for administration These are recommendations not requirements
Helpful information bull Educate staff on the importance of preparing vaccine immediately before administration Pre-drawing of vaccines may lead to concerns related to vaccine viability potency sterility and wastage
Page 46 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 6 Inventory Question 61
6 Inventory Inventory Comparison
Question 61 Visually inspect storage units to determine if existing supply of vaccines proportionately mirrorspopulations served Choose the most accurate statement below
Note to Reviewer bull CDC recommends that providers maintain a four-week supply of inventory bull For this question do not take into account vaccine types that the provider does not order Here simply
make sure that overall the vaccines in the providerrsquos storage units are available in sufficient amounts toserve their patient population
Answers (Choose one)
The current vaccine inventory proportionately reflects the populations identified Only public stock is insufficient [X] Only private stock is insufficient [X] Both public and private stock are insufficient [X] Site uses the replacement method but does not appear to have enough vaccine for their population [X] Other [X]
Review CDC Requirement
VFC providers must order and stock routine vaccines in accordance with their patient population in order to prevent missedvaccination opportunities Having sufficient amounts of all stocks prevents the inadvertent use of VFC vaccines for non-VFC-eligiblepatients and vice versa
Goal of this question Assess whether the site is ordering appropriate quantities of vaccine for the population they serve at their site
Helpful information bull If the site sees 30 percent private-pay patients and 70 percent VFC the stock in their storage units should reflect that proportion If you donrsquot know you can ask the site about their population
bull This is meant to be a general assessment so in a big site if they have only a small amount of vaccine that may indicate an issue with vaccine management
bull CDC recommends smaller more frequent orders (ie monthly) rather than large orders to minimize the amount of vaccine loss if an incident occurs during shipment or in the storage unit Sites should not order more frequently than once a month
bull Sites using the replacement method will only have one stock but it should appear to be large enough for their population
bull Only assess the vaccine types that the site currently stocks in their unit We know there are sites that do not offer all ACIP-recommended vaccines for various reasons That issue will be addressed in question 62
IPI Advisor Manual | February 2017 Page 47
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 626 Inventory ACIP Recommended Vaccines
Question 62 Review providerrsquos current inventory to answer the questions below
A Does the provider offer all routine ACIP-recommendedvaccines for their patient population
Yes (Skip to question C) No [X] Offers all except varicella because direct ship ofvaccine is unavailable from manufacturer
B Which routine vaccines are NOT being offered DTaP Hepatitis A Hepatitis B HIB HPV Influenza Meningococcal
MMR Pneumococcal Polio Rotavirus TdapTd Varicella
C According to Immunization Program Policy does theprovider make accessible all non-routine ACIP-recommended vaccines for those VFC patients whomeet the criteria for receiving them
Yes (Skip to question 63) No [X]
D Which non-routine vaccines are NOT being offered Pneumococcal polysaccharide vaccine (PPSV23) Meningococcal Group B (MenB) Other
Review CDC Requirement
VFC providers agree to comply with immunization schedules dosages and contraindications that are established by the Advisory Committee on Immunization Practices (ACIP) for the vaccines identified and agreed upon in the Provider Agreement UNLESS bull In the VFC providers medical judgment and in accordance with accepted medical practice the VFC provider deems such
compliance to be medically inappropriate for the child bull The particular requirements contradict state law including laws pertaining to religious and other exemptions The VFC program entitles children to the following vaccines DTaP Hepatitis A Hepatitis B HIB HPV Influenza MeningococcalMMR Pneumococcal Polio Rotavirus TdapTd and Varicella VFC providers are also required to ensure that VFC-eligible children have access to non-routine vaccines as needed
Goal of this question Assess if the site is offering all the ACIP-recommended vaccines for the population they serve and these vaccines are in stock on the day of the visit It is important that every MnVFC-eligible child that comes to a providerrsquos office for an immunization is vaccinated
Helpful information bull The Advisory Committee on Immunization Practices (ACIP) is a group of medical and public health experts that develops recommendations on how to use vaccines to control diseases in the United States
bull Specialty providers are not required to offer all routine vaccines but should provide the vaccines appropriate for their population
bull If the site does not offer all routine ACIP-recommended vaccines appropriate for their population check the ldquoNordquo box in Part A then check the appropriate box(es) in Part B for any vaccines not offered Please contact MDH as this situation offers us the opportunity to provide education to the site
bull For non-routine vaccines they must either be in stock or the site must have an alternative protocol in the routine management plan that ensures these children have access when applicable
Resources bull IAC Diseases and Vaccines (wwwimmunizeorgvaccines) bull CDC Advisory Committee on Immunization Practices (ACIP) (wwwcdcgovvaccinesacipindexhtml)
Page 48 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 636 Inventory Separation of Stock
Question 63 Observe how the provider differentiates stock in each storage unit to answer the questions below
A Is it clear which vaccines belong to public stock andwhich belong to private stock
Yes No [X] Not applicable replacement site
B Is it clear which vaccines belong to VFC stock andwhich belong to UUAV stock
Yes No [X] Not applicable replacement site Not applicable not UUAV-enrolled site
Review CDC Requirement
In order to ensure that VFC vaccines are only administered to VFC-eligible children VFC providers that serve both VFC and non-VFCshyeligible children must maintain their vaccine inventories in such a way that they can clearly differentiate public stock from privatestock as well as VFC from other public stock
Goal of this question Assess whether the site can distinguish between MnVFC vaccine and private vaccine If they participate in the Uninsured and Underinsured Adult Vaccine (UUAV) program they should also be able to distinguish between MnVFC stock and UUAV stock Some sites use labels bins boxes etc to differentiate their stock If it is not clear how the site differentiates their stock discuss vaccine management with the staff For follow-up call MDH to discuss doing a follow-up site visit
Sites using the replacement method will not have separate stocksmdashthis is an approved alternative method for keeping track of vaccine
Resource bull Section 10 of the MnVFC Policy and Procedure Manual
IPI Advisor Manual | February 2017 Page 49
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
MnVFC Site Visit Storage and Handling Per Unit Answer Sheet 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet MnVFC PIN ___________________
Question number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
Temperature Monitoring Device Questions Questions 43 47 must be answered separately for the freezer and refrigerator if the unit is a combo Be sure to document responses in the appropriate column
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
All the questions on the Site Visit Storage amp Handling Per Unit Answer Sheet have been discussed previously in section 4 of this manual Use this sheet to record information about all the units at the site visit You will need one sheet for each unit If it is a combination unit (either pharmaceutical or household) you can record both sections on one sheet If they have stand-alone units use one sheet for each unit Do not enter the answers to the questions in section 4 of the questionnaire
If you need more information about any of the questions refer back to the main questionnairemdashthe complete question additional guidance including notes to the reviewer and the CDC requirements are there Also if the site is not meeting the requirement you will go back to the questionnaire to complete the ldquoActions if Non-compliantrdquo section including the root cause analysis and follow-up sections
When you have completed the assessment of all the storage units remember to go back to the questionnaire to complete sections 5 and 6
Page 50 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
ndash
ndash
MnVFC Provider Follow-up PlanThe goal of the Provider Follow-up Plan is to communicate with the site all of the VFC requirements any unmet requirements found during your site visit and the timeline for completing the required action The left hand column is a box to check for ldquoUnmetrdquo requirements
Helpful information bull The form can be used to review what the site is doing well and what they need to work on
bull For requirements that have specific documentation that needs to be sent to you use the notes section
2017 MnVFC Provider Follow-up Plan Site _______________________________________________ MnVFC PIN ____________ Date of Visit ___________
Thank you for participating in this MnVFC compliance site visit Please review this visit summary including follow-up actions and timelines for completion Unmet MnVFC requirements and recommendations have a checked box next to them The goal of this plan is to support you with successfully implementing the program and improving access to vaccines for VFC-eligible children
Unmet Question VFC Requirements Section 1 Changes to Key Staff
Q12 Change in the Medical Director Immunization Manager Vaccine Coordinator or back-upKey Staff must be communicated to the immunization program by emailing healthmnvfcstatemnus Changes Notes
Q12 Key staff must complete the annual training on VFC program requirements and print theAnnual Training certificate of completion Documentation Required Action
Staff that have not completed the MnVFC online training must complete it and send acopy of the certificate to the reviewer Training can be found on the MnVFC website (wwwhealthstatemnusvfc) Due date 1 month
Notes
Unmet Question VFC Requirements Section 2 Eligibility
Q21 Provider staff must possess a working knowledge of all VFC eligibility criteria and use thoseVFC Eligibility criteria to screen children prior to administering VFC vaccines
Categories Notes
bull This form provides documentation needed for follow-up actions when you send your thank you email
The second to last page of the Provider Follow-up Plan has a summary of the MnVFC program recommendations These are to remind the site about best practices they may want to improve upon even though they are not yet requirements of the program For example you could discuss the recommendation about storage units if they currently have a combination household unit and are using both sections
The last section is for your signature and the person you met with In most sites it will be the immunization manager or vaccine coordinator who signs the form unless the medical director attended the site visit You keep the original copy and the site will need to keep a copy for themselves
To be completed by the site visit reviewer
I acknowledge that a VFC site visit was performed on __________________ (visit date) The follow-up plan which includes a list of all current VFC program requirements and recommendations assessed during the visit and any required follow-up actions was provided at the end of the visit
Site visit reviewer
Phone
Reviewer Signature Date
To be completed by the provider
I acknowledge that our practice took part in the VFC site visit noted above I understand the findings of the visit and any required actions that must be taken by our office in order to meet VFC program requirements
Medical Director (or designee) Name Title
Medical Director (or designee) Signature Date
IPI Advisor Manual | February 2017 Page 51
The 2017 MnVFC Site Visit Paperwork Chapter 4
After the Site Visit Send a thank you email highlighting the unmet requirements documents you need from the site to resolve the issue(s) and the date you need them Make sure to include the link to the Site Visit Survey (httpssurveyvovicicomseashxs=56206EE334CE0B14)
Please refer to Chapter 3 for more information about future follow-up required after the visit including forms and documentation
Resource bull Sample Thank You letter on IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml)
Chapter 5
IPI Advisor Resource List MnVFC Program 651-201-5522
MnVFC wwwhealthstatemnusvfc
bull Separate Stock and Replacement Method Policies and Procedures Manuals bull Online trainings bull MnVFC Announcements sign up to receive them via email bull Ordering MDH vaccine bull MnVFC forms Screening forms Reporting forms Others MDH Nonviable Vaccine Form MDH Vaccine Transfer Record and Vaccine Borrowing Report
bull MnVFC promotional materials bull Immunization Billing Guidance for MnVFC and Immunization Billing Guidance for MnVFC Replacement Sites Immunization Practices Improvement Program (IPI) wwwhealthstatemnusdivsidepcimmunizeipi
bull IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml) bull IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml) IPI Resource Folder Contents (wwwhealthstatemnusdivsidepcimmunizeipiipifolderpdf)
Minnesota Immunization Information Connection (MIIC) wwwhealthstatemnusmiic
bull MIIC regions and regional coordinators
Clinical Practice MDH Immunization Program wwwhealthstatemnusimmunize
Got Your Shots News wwwhealthstatemnusdivsidepcnewslettersgys
MDH Immunization Information for Health Care Providers wwwhealthstatemnusdivsidepcimmunizehcp
bull Got Your Shots A Providers Guide to Immunization in Minnesota bull Vaccine protocols bull Forms for tracking patient immunizations bull Immunization schedules for Health Care Providers Immunization Action Coalition (IAC) wwwimmunizeorg
bull Ask the Experts bull VISs (Vaccine Information Statements and translations) bull Administration screening questions bull Medical management of vaccine reactions bull Order form for Californiarsquos Immunization Technique DVD Best Practices with Infants Children and Adults
Page 52 IPI Advisor Manual| February 2017
IPI Advisor Resource List Chapter 5
CDC ldquoPink Bookrdquo wwwcdcgovvaccinespubspinkbookindexhtml
CDC Advisory Committee on Immunization Practices (ACIP) wwwcdcgovvaccinesacip
CDC Vaccines and Immunizations wwwcdcgovvaccines
VAERS reporting httpvaershhsgovindex
Storage and Handling Got Your Shots Providers Guide ndash Managing Vaccine wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml
MnVFC Guide to Temperature Monitoring Devices wwwhealthstatemnusvfc
MDH Clinicianrsquos Vaccine Mishap Checklist wwwhealthstatemnusdivsidepcimmunizeipivaxchklstpdf
MDH Vaccine Storage Guide wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml
CDC Vaccine Storage and Handling Toolkit wwwcdcgovvaccinesrecsstoragetoolkit
You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Vaccine manufacturer phone numbers wwwcdcgovvaccinespubspinkbookdownloadsappendicesFcontact-info-manufactpdf
IAC Checklist for Safe Vaccine Handling and Storage wwwimmunizeorgcatgdp3035pdf
IAC Donrsquot Be Guilty of These Errors in Vaccine Storage and Handling wwwimmunizeorgcatgdp3036pdf
Additional Resources Print materials from MDH ndash order forms wwwhealthstatemnusdivsidepcimmunizeordermathtml
Vaccine Education Center ndash Childrenrsquos Hospital of Philadelphia wwwchopeduservicevaccine-education-centerhomehtml
California Department of Public Health ndash Interactive training on vaccine administration and storage and handling handout on transporting vaccine and how to package wwwezizorg
IPI Advisor Manual | February 2017 Page 53
IPI Advisor Resource List Chapter 5
CDC vaccine price list wwwcdcgovvaccinesprogramsvfcawardeesvaccine-managementprice-listindexhtml
Vaccine Information Statements (VIS) wwwcdcgovvaccineshcpvisindexhtml
CEU Opportunities CDC Immunization Education and Training wwwcdcgovvaccinesedindexhtml
Immunization You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Page 54 IPI Advisor Manual| February 2017
- Introduction
-
- Welcome to the Immunization Practice Improvement (IPI) Program
- Contact Information
-
- Chapter 1
- Requirements to Participate in the MnVFC Program
- Vaccines for Children Program
- Chapter 2
- Reimbursement for MnVFC Visits
- Types of Visits
- Your MnVFC Clinical CoordinatorPlanner
- New IPI Advisor Training Requirements
- Your Role as an IPI Advisor
- Reasons MDH Would Do All or Part of a Visit
- Chapter 3
- Future follow-up
- Conducting the Visit
- Preparing for the Visit
- Information for the Visit
- Site Visit Checklist
- Scheduling the Visit
- Chapter 4
- After the Site Visit
- MnVFC Provider Follow-up Plan
- MnVFC Site Visit Storage and Handling Per Unit Answer Sheet
- Section 6 Inventory
- Section 5 Storage amp Handling Site-Wide
- Section 4 Storage amp Handling Per Unit
- Section 3 Documentation
- Section 2 Eligibility
- Section 1 Provider Details
- The Site Visit Reviewer Legend
- MnVFC Site Visit Questionnaire
- Required Paperwork for Site Visits
- Chapter 5
-
Chapter 3 Site Visits Scheduling the Visit
bull Check the information sheet or contact the site to confirm who the contact person is in charge of the MnVFC program In general this is the immunization manager or vaccine coordinator If the contact is no longer there ask for the person in charge of the sitersquos vaccines or the clinic manager They can usually direct you to the appropriate person You may want to follow a suggested phone script when contacting the site
Sample Phone Script for Scheduling a Visit
ldquoHello My name is _______ I am calling from ________ Health Department May I speak to (contact name) [If not available determine appropriate person to talk to or a better time to call back] I am calling to schedule a MnVFC site visit This visit will involve a review of immunization practices at your site We will look at vaccine administration storage and handling screening for eligibility and documentation of vaccinations It usually takes about two hours for a visit depending on the number of vaccine storage units you have Is there a day or time of day that works best for you
I have a pre-visit worksheet to send to you to help you prepare for the visit It contains information about what I will need at the visit such as temperature logs and immunization documentation information Completing this worksheet prior to me arriving will help the visit be more efficient Is there any other information that I can send to help you prepare for the visit
If you have any questions call me at ________ Thank you for your time and assistance I look forward to working with yourdquo
bull Arrange a date and time for the visit bull Let them know an approximate visit length Visits are usually around two hours long depending on the size of the site the number of vaccine storage units they have or if they have new staff
bull Request that key staff be present at the visit This could include the immunization manager vaccine coordinator immunization staff clinic manager nurse manager billing staff andor medical director
bull Inform your site contact that you will be sending them an email confirmation along with the MnVFC
Pre-Visit Worksheet
Site Visit Checklist Use the Site Visit Checklist on IPI Advisor Site Visit Materials (wwwhealthstatemnusdivs idepcimmunizeipisvmaterialshtml) to make sure all necessary steps are covered
MINNESOTA VA C CI N ES FO R CHI LD REN PROGRAM
Site Visit Checklist Date of visit Time
Site Name PIN
Address
Contact Phone
Complete Before the visit Comments
Review the clinic list Identify and prioritize which sites you will visit
Email or call to schedule a date and time for the visit Ask for the immunization manager or vaccine coordinator
Email appointment confirmation attach Pre-visit Worksheet and provide instructions for returning it prior to the visit (sample email on website) Include length of the visit and which staff should be present
Add site visit to Outlook calendar and reserve a car (if needed)
Review temp logs and Pre-visit Worksheet
Send a reminder email 2-3 days ahead of the visit
IPI Advisor Manual | February 2017 Page 11
i i li
Site Visits Chapter 3
Information for the Visit2017 MnVFC Pre-Visit Worksheet Site name MnVFC PIN
Address
Medical director Email
Immunization manager Phone
Vaccine coordinator Phone
Vaccine coordinator back-up Email
IPI Site Vis t Preparat on Check st
The staff listed have completed the MnVFC online training and printed a certification of completion Immunization Manager Vaccine coordinator Vaccine coordinator back-up
Have a copy of the most recent provider agreement
Check if the above listed staff have changed since the provider agreement was completed
Check all of the vaccines administered at your site and list the corresponding publication date for each VIS you give to patients
DTaP _____________ Hepatitis A _____________ Hepatitis B _____________ Hib _____________ HPV _____________
Influenza _____________ MCV4 _____________ MMR _____________ MMR-V _____________ PCV13 _____________
Polio _____________ Rotavirus _____________ Tdap _____________ Varicella _____________
Non-Routine Vaccines Men B__________ PPSV23 _____________ Td _____________
Vaccine administration fee charged for MnVFC eligible children is $
Have a Vaccine Management and Emergency Plan that has been reviewed and dated within the last year
Have the borrowing reports if applicable for the last 12 months available at the visit
Have an anaphylaxis protocol that is clearly posted and reviewed annually
Send an appointment reminder email and the MnVFC Pre-Visit Worksheet to the MnVFC contact A sample letter and the MnVFC Pre-Visit Worksheet can be found on the IPI Advisor Site Visit Materials (wwwhealthstate mnusdivsidepcimmunizeipisvmaterialshtml) page You can request that the MnVFC Pre-Visit Worksheet and temperature logs be sent to you prior to the visit for your review
Contact the site by phone or email one or two working days before the scheduled visit to confirm your appointment This is also a good time to ask for directions and parking information if you are not familiar with the site
Preparing for the Visit Review the site visit paperwork to familiarize yourself with the questions For most of the questions there is a ldquoNote to the reviewerrdquo These notes give helpful tips about the information you are looking for when asking this question It contains the rationale for the question and which resources to provide to the site to support the rationale Some sections also require immediate on-site actionsmdashthings you must do while you are at the site and some require future follow up
bull Print copies the of site visit paperwork bull Site visit forms are available on the IPI Advisor Site Visit Materials (wwwhealthstatemnusdivs idepcimmunizeipisvmaterialshtml) page 2017 MnVFC Site Visit Questionnaire 2017 MnVFC Site Visit Storage amp Handling per Unit Answer Sheet (print one for each stand-alone andor combination storage unit at the site) 2017 MnVFC Provider Follow-up Plan (print two copies)
bull Review any previous site visit paperwork that is available You should check in with MDH staff after your visits if the site continues to have the same issues as past visits
bull Also be sure to bring Your thermometers If the sitersquos certificate of calibration is expired or the probe is not properly placed place your thermometer in the storage unit when you arrive and read the temperature just prior to reviewing the site visit findings
The MnVFC folder with additional immunization resources you wish to add (see chapter 5) and the Vaccine Storage amp Handling magnet (to order email healthIPIinquiriesstatemnus) A copy of the appropriate MnVFC Policies and Procedures Manual found on the MnVFC website (wwwhealthstatemnusvfc) Appropriate temperature logs (Celsius or Fahrenheit) Site information sheet that contains the quantity and value of the vaccine distributed to the sitesystem
Page 12 IPI Advisor Manual | February 2017
Site Visits Chapter 3
Conducting the Visit Education is a large part of the MnVFC site visit Often approaching this visit as an exchange of information with the site is more successful than a ldquoregulatoryrdquo visit Putting the staff at ease answering their questions and making a plan to address issues that arise during the visit is more helpful than a ldquopassfailrdquo attitude Education will usually consist of providing the rationale for the requirement referring to the requirement in the MnVFC Policies and Procedures Manual and providing resources to help address the situation Some questions will require additional follow-up to assure the site has corrected the issue(s) and is meeting the MnVFC requirement(s) This will be addressed further in the follow-up section
Completing the Paperwork
There are three documents that you must complete for the MnVFC site visit bull 2017 MnVFC Site Visit Questionnaire bull 2017 MnVFC Site Visit Storage amp Handling per Unit Answer Sheet (one for each storage unit) bull 2017 MnVFC Provider Follow-up Plan (two copies or you may ask them to make you a copy of the completed form for their records)
Answer the questions on the MnVFC Site Visit Questionnaire based on how things are when you arrive at the site If they correct the issue during the visit you will still mark it as an unmet requirement and document how it was addressed during the visit
The ldquoAnswerrdquo field will contain all the possible answer choices for this question For most questions answer choices will be followed by the markings below
bull Answer choices with no marking mean the site meets the CDC requirement bull Answer choices marked with an [X] indicate that this specific answer choice is non-compliant with a CDC requirement
bull Answer choices marked with an [O] indicate that this specific answer choice is not aligned with a CDC recommendation
If you marked the box with the [X] which is non-compliant with the CDC requirement conduct a root cause analysis to determine the reason for non-compliance Root cause analysis is an important component to a successful site visit It is used to identify the cause of the problem and help to resolve the issue There are several possible root causes that can be identified Choose only one root cause
bull Human cause Personal beliefsopinions Does not understand rationale of requirement Lack of concern for compliance
bull Organizational cause Competing job assignmentsworkload Lack of (insufficient) staff to perform required duties Budget limitations (for required equipment) Lack of (insufficient) training of staff Lack of (insufficient) processesprotocols
IPI Advisor Manual | February 2017 Page 13
Site Visits Chapter 3
Once identified the root cause should be documented in the questionnaire including a brief explanation of why you chose that cause This allows for follow-up with the site and a way to help find improvements to meet the unmet requirement Complete any immediate on-site action These often require providing education and resources for the site Mark the box for each action taken If you provide additional resources or information you can use the notes section to indicate the additional items
ldquoFuture follow-uprdquo are actions the site needs to take to meet the requirements of the program Wersquoll go over more specific information about the site visit questionnaire in Chapter 4
Performing the Site Visit
As you become familiar with the MnVFC program and develop a relationship with your sites you will develop a visit pattern that works for you Here is one possible sequence for conducting MnVFC site visits
bull When you arrive at the site if you have a business card it is helpful to provide it to the front desk staff person
bull When you meet with the immunization manager andor vaccine coordinator introduce yourself and explain the expectations for the visit
bull Ask to see the temperature monitoring device(s) It must have a current certificate of calibration and the probe must be properly placed in the unit If it does not meet the requirements place your thermometer in the unit at the beginning of the visit so that it has sufficient time to reach an accurate temperature by the time you complete your assessment of the storage units
bull 2017 MnVFC Site Visit Questionnaire Ask all of the questions You may have to modify the order of the questions based on what is best for the site When you get to the storage and handling section (section 4) use the answer sheet(s) to document the answers to the questions for each storage unit that stores vaccine (MnVFC or private) Do not write answers in the questionnaire unless there is an unmet requirement Be sure to ask if there is vaccine stored anywhere else at any time at this location This includes a co-located pharmacy If so these additional units will need to be assessed as well If the site has a combination refrigeratorfreezer household unit and is using both sections discuss with them the recommendation (and probable future requirement) to have a separate freezer Refer to MDH if they have further questions or need more information Be prepared to address any storage and handling mishaps that you may find A copy of the
Clinicianrsquos Vaccine Mishap Checklist is with your visit materials and the Emergency Response Worksheet is in the MnVFC Policy and Procedure Manual If you are unsure how to handle the problem call the MnVFC program at 651-201-5522 during or after the visit
Page 14 IPI Advisor Manual | February 2017
Site Visits Chapter 3
Ending the Visit bull Fill out the two copies of the 2017 MnVFC Provider Follow-up Plan (or ask them to make a copy once it is completed for their records) Indicate if they have not met the requirement by checking the box in the ldquoUnmetrdquo column If they are not meeting requirements check the required actions Review the plan with them reinforcing the positive things they are doing as well as reviewing the required follow-up action(s) Give the site a copy of the Provider Follow-up Plan Keep the signed copy of the Provider Follow-up Plan to submit with your paperwork Do not leave a copy of the Site Visit Questionnaire at the site
bull Let them know you will be sending a thank you email that will summarize the site visit Included in the email will be a survey link you would appreciate them completing regarding the visit
After the Visit bull Send the site a thank you email There is a template thank you letter on the IPI Advisor Site Visit Materials (wwwhealthstate mnusdivsidepcimmunizeipisvmaterialshtml) page Be sure you include the issues that you identified and the timeline for their completion as well as the good things you found at the visit In the template letter be sure to include the survey link The survey is very brief ndash a few questions and space to write comments
bull Either transfer your MnVFC Site Visit Questionnaire and MnVFC Site Visit Storage amp Handling per Unit Answer Sheet information to the fillable version or submit the handwritten form to MDH
Documentation of the Visit
Paperwork must be submitted to MDH within 10 days of the visit in order to meet the federal VFC programrsquos reporting requirements Do not wait to complete your follow-up before submitting the site visit paperwork
Send the following documents to MDH bull 2017 MnVFC Site Visit Questionnaire (includes the cover sheet) bull 2017 MnVFC Site Visit Storage amp Handling per Unit Answer Sheet (one for each unit) bull 2017 MnVFC Provider Follow-up Plan (original signed plan)
Submit site visit materials to bull Email healthIPIinquiriesstatemnus (preferred) bull Mail IPI Program Specialist
Immunization Practices Improvement Program Minnesota Department of HealthPO Box 64975St Paul MN 55164-0975
IPI Advisor Manual | February 2017 Page 15
Site Visits Chapter 3
Future follow-up Follow-up is an important component of the site visit It helps us ensure that the unmet requirements have been corrected The questionnaire has different time periods for follow-up depending on the question Do not wait to complete your follow-up before submitting the site visit paperwork
When you complete the Follow-Up Form make sure to keep a copy for yourself MDH also keeps track of follow-up required and will remind you if follow-up has not been completed by the deadline Most follow-up can be done with a phone call or email In-person follow-up is rarely required and should be discussed with MDH before scheduling a follow-up visit
All requirements that need follow-up are identified with a [X] on the site visit paperwork and are listed on the MnVFC Provider Follow-up Plan
bull Follow-up with the site to see how they have resolved the unmet requirements bull Document your follow-up on the Follow-Up Form available on the IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml) page If follow-up was done via letter or email a copy can be attached to the Follow-Up Form
bull Send your Follow-Up Form to MDH (healthIPIinquiriesstatemnus) with supporting documents and emails
bull If a site is not responding to your requests regarding follow-up contact your MnVFC clinical coordinatorplanner They can help with additional follow-up as needed
Page 16 IPI Advisor Manual | February 2017
Chapter 4 The 2017 MnVFC Site Visit Paperwork This chapter will go through the required MnVFC site visit paperwork with notes about information or resources to help the site address questions or issues that may arise during the visit
The MnVFC site visit paperwork is available on the IPI Advisor Site Visit Materials (wwwhealthstate mnusdivsidepcimmunizeipisvmaterialshtml) page
Please download the paperwork shortly before your visit as there may be updates and changes and this will be the most up-to-date version of the questionnaire We will send out a Workspace message with major changes
Required Paperwork for Site Visits bull 2017 MnVFC Site Visit Questionnaire bull 2017 MnVFC Storage amp Handling Per Unit Answer Sheet ndash one for each unit assessed during site
visit bull 2017 MnVFC Provider Follow-up Plan ndash with provider signature
Make sure to include the sitersquos PIN on all your paperwork Please complete and submit your site visit paperwork as soon as possible after your visit It may be helpful to schedule some time into your calendar to complete your paperwork in the days following your visit Once you have completed the post-visit follow-up send in the Follow-Up Form with documentation of the follow-up actions Please do not wait until you have completed your follow-up before sending in your initial paperwork
MnVFC Site Visit Questionnaire The questionnaire includes these six sections 1 Provider details 2 Eligibility 3 Documentation 4 Storage amp handling per unit 5 Storage amp handling site-wide 6 Inventory
IPI Advisor Manual | February 2017 Page 17
Page 18 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
The Site Visit Reviewer Legend The legend explains the formatting of the 2017 questionnaire This includes information that will be helpful in completing the site visit
Site Visit Reviewer Guide Legend
Section Number Content Area
Question number This area will always contain the text of the question
Note to reviewer The note to reviewer contains information that is necessary for properly asking and assessing responses tothe question above This may include definitions of terms requirement details and other helpful tips
Answers This field will contain all the possible answer choices for this question For most questions answer choiceswill be followed by the markings below
Answer choices marked with an [X] indicate that this specific answer choice is non-compliant with a CDC requirement Answer choices marked with an [O] indicate that this specific answer choice is not aligned with a CDC
recommendation
Review CDC RequirementRecommendation
This field will be populated with the CDC requirementrecommendation associated with the given question
Actions if Non-Compliant
Root Cause Analysis As part of the site visit reviewers are required to assess and understand the reasons why a provider office isnon-compliant with VFC program requirements ndash this is a root cause analysis Reviewers must choose theone root cause that they believe most contributes to the non-compliance Upon establishing the root causethe reviewer must provide a clear explanation of hisher findings
Immediate Action These are actions that CDC requires reviewers to take on site during the visit
Future Follow-up These are future follow-up actions (with designated due dates) that are required of the reviewer andorprovider to remedy non-compliance Reviewers must complete all follow-up in accordance with CDCestablished deadlines
Notes Information you want the VFC program to be aware of or that explains your answer in detail
bull Note to reviewer These are notes to help you understand what the question is asking for and to clarify things you might want to know when asking or rephrasing the question
bull Answers This section helps you to know when the answer does not meet the CDC requirement [X] or recommendation [O] Whenever an answer with a [X] is checked the ldquoActions if Non-compliant section must be completed The recommendations are usually good teaching points about best practices andor future requirements of the VFC program
bull Review the CDC RequirementRecommendation This section provides a specific outline of the requirement or recommendation to give you information to use in talking with the site staff
bull Actions if Non-Compliant This section describes what to do if the site is not meeting a requirement Root cause analysis This section asks you to probe beyond the surface to find what is driving the non-compliance It is intended to help uncover reasons for recurring non-compliance issues identify additional training needs and inform reviewer follow-up actions Select only one root cause and explain the particular circumstances in the space ldquoExplanation of root causerdquo line provided If there appear to be multiple issues choose the one that most contributes to the non-compliance and describe all factors in the explanation Immediate actions A list of actions to take during the site visit to address the issue Future follow-up A list of actions to take after the site visit by the set deadline
bull Notes This section can be used for notes to yourself or to MDH
IPI Advisor Manual | February 2017 Page 19
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 1 Provider Details Questionnaire Coversheet
The first page of the questionnaire collects the demographic information for the site You can use this page to help prepare for the visit Most of the demographic information about the site should be on the site-specific document you received with your clinic list You will validate that this information is current at the time of the site visit It also helps to know if this is a separate stock site or a replacement site before the visit so you can bring a copy of the appropriate MnVFC Policies and Procedure Manual
2017 MnVFC Site Visit Questionnaire Date of visit _____________ Date forms sent to MDH ______________
Site Information
Site name MnVFC PIN
Address Separate Stock Replacement
City ZIP County
Medical Director Email
Immunization Manager Phone
Vaccine Coordinator Phone
Vaccine Coordinator back-up Email
Point of contact Phone
Personnel at site visit
On this page bull The date of the visit and the date when you send these forms to MDH This information helps us track the timeliness of our review and data entry process
bull The vaccine management method used by the site (replacement or separate stock) bull The name and email of the medical director (ideally this is the person who signed the MnVFC
Program Provider Agreement)bull Contact information for the immunization manager vaccine coordinator vaccine coordinator back-up and point-of-contact for this visit The immunization manager vaccine coordinator vaccine coordinator back-up roles are
described in the MnVFC Policies and Procedure Manual The vaccine coordinator back-up may be the immunization manager or another staff person depending on the size of the site and available personnel The Point of Contact is the person you set up the appointment with signs the Provider Follow-
up Plan and receives the follow-up email This may be one of the people listed above
The Post Visit Steps section is a reminder to you about what needs to done after the visit The Education on Immunization Best Practices for Sites section reminds you to provide the resource folder to the site
Page 20 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 12
1 Provider Details Changes to Key Staff
Question 12 Ask the provider about changes to key staff to answer the questions below
A (Choose all that
apply)
At the time of the visit is the Medical Director the same individual that signed the ProviderAgreement and are the Immunization Manager and Vaccine Coordinator the same asthose last reported to the program
Yes No the Medical Director has changed No the Immunization Manager has changed No the Vaccine Coordinator has changed
B (Choose one)
Were all changes communicated to theImmunization Program according to yourprogramrsquos policy
Yes or no staff changes No [X]
C (Choose one)
Based on review of the trainingdocumentation have the current Immunization Manager Vaccine Coordinator and back-up completed all required training
Yes No [X]
Review CDC Requirement
All changes in key staff must be communicated to the Immunization Program in the manner and timeframe defined by theImmunization Program Key staff include the Medical Director or equivalent who signed the Provider Agreement the Immunization Manager Vaccine Coordinator and the back-up VFC providers are required to ensure that all key staff are fully trained on VFC program requirements at all times All training must be documented
Goal of this question Determine if there are new staff in key positions at the site and to make sure staff are properly educated about the MnVFC program A This information can help you determine the level of knowledge and experience the staff have with the MnVFC program Follow-up throughout the visit can be tailored for various levels of staff experience Likewise you may identify additional training needs for new staff
B When sites notify us of changes in key personnel we update their information in MIIC and on the clinic lists We also send the new staff information for completing the online training and direct them to read the appropriate MnVFC Policies and Procedures Manual If the answer to this part is no update the demographic area of the questionnaire and inform the staff that in the future they must notify the MnVFC program (via email or phone) if the immunization manager or vaccine coordinator changes Resource Section 12 of the MnVFC Policies and Procedures Manual
C Annual training must be verified by looking at the certificates for the online training If the answer to this part is no refer the staff to complete the appropriate MnVFC online training found on the MnVFC website (wwwhealthstatemnusvfc) for their program (separate stockreplacement) for the current year and send you a copy of the certificate within 30 days
Resource bull Sections 12 and 14 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 21
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 2 Eligibility Question 21
Goal of this Question Assess whether staff correctly understand which patients are eligible for the MnVFC program Screening ensures that eligible children receive the vaccines that they are entitled to receive under the MnVFC program and helps to prevent fraud or abuse of the program
Children 18 years and younger in these
categories can receive MnVFC vaccine at any enrolled site bull Uninsured bull Enrolled in a Minnesota Health Care Program (MHCP) Medical Assistance (MA) or MinnesotaCare bull American Indian or Alaskan Native
The following categories are considered underinsured and are only MnVFC-eligible at local public health (LPH) Federally Qualified Health Centers (FQHC) Rural Health Centers (RHC) Indian Health Services (IHS) and tribal health clinics
bull Has health insurance that does not cover one or more vaccines as can be the case with newly licensed vaccines that arenrsquot yet covered (MnVFC-eligible for non-covered vaccines only)
bull Has health insurance that caps vaccine coverage at a certain amount Once that amount is reached the child is MnVFC-eligible
Children with insurance that does not cover vaccines until a deductible has been met are considered to be fully insured and are not MnVFC-eligible
Helpful information bull Sites are not required to verify the patientrsquos response to the screening questions For example if a patient states they lost their insurance the site does not need to call the patientrsquos insurance company to confirm
If the site cannot correctly describe the eligibility categories provide educational materialsresources on MnVFC eligibility requirements
Resources bull Patient Eligibility Screening Record on MnVFC Forms (wwwhealthstatemnusdivsidepc immunizemnvfcformshtml)
bull Section 1 of the MnVFC Policies and Procedures Manual
2 Eligibility VFC Eligibility Categories
Question 21 Was the individual responsible for determining patient VFC eligibility able to explain all the factors(including age) that make a child eligible to receive VFC vaccines
A Patient is less than 19 years of age Yes No [X]
B Patient is Medicaid-eligible Yes No [X]
C Patient is uninsured Yes No [X]
D Patient is underinsured Yes No [X]
E Patient is American Indian Yes No [X]
F Patient is Alaska Native Yes No [X]
Review CDC Requirement
VFC providers must possess a working knowledge of all VFC eligibility criteria and use those criteria to screen children prior toadministering VFC vaccines In order to receive VFC vaccine a patient must be under the age of 19 and must be at least one of the following (1) Medicaid-eligible (2) Uninsured (ie child has no health insurance) (3) Underinsured (ie child has health insurancebut coverage does not cover any or certain vaccines ndash underinsured children may only receive VFC vaccines in FQHCRHC ordeputized VFC provider offices and only for vaccines not covered by insurance) and (4) American Indian or Alaska Native (AIAN)
Page 22 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 22
2 Eligibility Billing Practices
Question 22 Is the individualdepartment responsible for billing able to clearly explain how they bill for both the costof vaccine and the vaccine administration fee for each of the eligibility categories below
A Medicaid-eligible Cost of Vaccine Do not bill ndash provided by VFC Admin Fee Bill Medicaid
Yes No [X]
B Uninsured Cost of Vaccine Do not bill ndash provided by VFC Admin Fee If billing can bill patient
Yes No [X]
C Underinsured Cost of Vaccine Do not bill ndash provided by VFC through FQHCsRHCs or deputized providers only all other providers cannotprovide VFC vaccine to underinsured patients Admin Fee If billing can bill patient
Yes No [X]
D American IndianAlaska Native(AIAN)
Cost of Vaccine Do not bill - provided by VFC unless patient is fully insured and parent chooses to use insurance Admin Fee If patient is Medicaid-eligible bill Medicaid if billingand patient is uninsuredunderinsured can bill patient if parentchooses to use private insurance for cost of vaccine billpatientinsurance
Yes No [X]
E Do individuals responsible for billing have access to the results of eligibility screening toensure proper billing
Yes No [X]
Review CDC Requirement
VFC providers must adhere to proper billing practices for vaccine administration fees and clearly understand that VFC vaccine isprovided at no cost to both the VFC provider and eligible children At no time should billing occur for the cost of VFC vaccine Whenadministering VFC vaccine providers should never bill two different ldquopayersrdquo (ie patient Medicaid insurance) for the samevaccine administration fee amount For Medicaid-eligible children Medicaid should be billed for the vaccine administration fee Forall other VFC-eligible populations the patient may be billed within the stateterritory cap established by the Centers for Medicareand Medicaid (CMS) However patients cannot be turned away or reported to collections for inability to pay the administration fee
Goal of this question Determine if the staff correctly understand how to bill patients that are eligible for the MnVFC program Billing appropriately ensures that children can receive low cost immunizations and the site is in compliance with the VFC program
bull If there is any indication that sites could be billing insurance companies or parents for VFC vaccines this should be investigated further
bull Most sites in Minnesota will bill Medicaid with the SL modifier ndash which indicates this is a Medicaid claim
bull The main point is to ensure the site is not billing uninsured children for VFC vaccine and are not charging them more than $2122 per vaccine for the administration fee
bull Non-compliance is usually unintentional and may be resolved with some training In rare cases it could be a glimpse into a larger problem where a site is intentionally billing for financial gain
bull If you think the site is billing inappropriately it is the responsibility of the IPI advisor to report concerns to MDH staff for further assistance
Resources bull Immunization Billing Guidance for MnVFC (wwwhealthstatemnusdivsidepcimmunizemnvfc billingtipshtml) or Immunization Billing Guidance for MnVFC Replacement Method Sites (www healthstatemnusdivsidepcimmunizemnvfcreplacementbillingtipsrephtml)
bull Section 2 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 23
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 232 Eligibility Vaccine Administration Fee
Question 23 Document the actual vaccine administration fee charged to non-Medicaid VFC-eligible patients (confirmwith billing department)
Answers Fee $ [X] Follow-up is required if the provider charges more than the fee cap establishedby the Centers for Medicare and Medicaid (CMS) for your stateterritory ($2122)
Review CDC Requirement
The VFC providerrsquos vaccine administration fee for non-Medicaid VFC-eligible children must not exceed the stateterritory vaccineadministration fee cap established by the Centers for Medicare and Medicaid (CMS) For current fee caps refer to Medicaid Program Payments for Services Furnished by Certain Primary Care Physicians and Charges for Vaccine Administration Under theVaccines for Children Program Final Rule (httpwwwgpogovfdsyspkgFR-2012-11-06pdf2012-26507pdf)
Goal of this question Ensure that sites are not charging more than the federal allowable vaccine administration fee of $2122
bull The Centers for Medicaid and Medicare (CMS) establishes a maximum fee that sites can charge to non-Medicaid-eligible VFC patients in each stateterritory for vaccine administration Health Plans usually negotiate this fee with the site but Medicaid will not pay more
bull If a parent cannot pay the vaccine administration fee the patient cannot be turned away or reported to collections VFC-eligible children must be vaccinated regardless of their ability to pay
bull If the person with whom you are conducting the site visit does not know the exact fee charged to non-Medicaid VFC-eligible patients ask to speak to someone who can verify the exact amount
bull If they are charging more than $2122 for the administration fee ndash please contact MDH staff for help with addressing this situation
Resources bull Immunization Billing Guidance for MnVFC (wwwhealthstatemnusdivsidepcimmunizemnvfc billingtipshtml) or Immunization Billing Guidance for MnVFC Replacement Method Sites (www healthstatemnusdivsidepcimmunizemnvfcreplacementbillingtipsrephtml)
bull Section 2 of the MnVFC Policies and Procedures Manual
Page 24 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 3 Documentation Question 31
3 Documentation Eligibility Screening amp Documentation
Question 31 To answer the questions below the provider must clearly demonstrate the patient intake processReview a minimum of 10 records that contain an immunization visit within the last 6 ndash 12 months
Note to Reviewer Criteria for Record Selection 1) Record selection must be completely random and the provider must not know prior to the visit which
records will be reviewed 2) Patient must have been 0-19 years of age at the last visit (Note Records of 19-year-old patients may
allow you to see if VFC vaccines are being used beyond the allowable age) 3) Must review a mix of public and private-pay patients (if applicable)
A Does the provider have a process that ensures that patients are screened forVFC eligibility at each visit and that screening results are documented at each visit
Yes No [X] (If no skip question F)
B Does the providerrsquos process ensure that staff administering vaccine know which vaccine stock to select from prior to drawing the vaccine
Yes No [X]
C Number of records reviewed If fewer than 10 records are reviewed select the reason why Provider does not have 10 patient records with immunizations in last 12 months
D Do all records contain date of the immunization visit and patientrsquos date of birth Yes No [X]
E Do all records contain the patientrsquos specific eligibility status associated with thedate of the immunization
Yes No [X]
F Do any of the providerrsquos records contain any evidence that the patient received vaccine for which they were not eligible
Yes [X] No
Review CDC Requirement
VFC providers must screen for and document VFC eligibility at each immunization visit Documentation must include the date of the visit and the childrsquos specific eligibility category VFC providers must use screening results to ensure that only VFC-eligible children receive VFC vaccine and that administration fees are billed for as appropriate Eligibility status must be readily available to staff administering vaccine prior to selecting which vaccine stock to use
Goal of this question Ensure the site is screening for eligibility and documenting the eligibility category in the medical record
Review a minimum of 10 records from within the last 6-12 months where the patient received an immunization You must review a mix of public and private pay patients (if applicable)
Random selection is important If the staff have pre-selected records for review do not use and identify additional randomly selected records to review
Helpful information bull Discuss upgrading the electronic health record to make documentation of VFC eligibility screening a required field Documenting eligibility screening in the immunization field promotes better MIIC data
bull Q 31 B Sites using the replacement method of vaccine management only have one stock so you will answer ldquoYesrdquo to this question
Resources bull Patient Eligibility Screening Record on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfcformshtml)
bull Section 1 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 25
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 32
3 Documentation Vaccine Dose Documentation
Question 32 Review a minimum of 10 patient immunization records from the last six months (or 12 months ifnecessary) to assess compliance with documentation requirements set forth by Statute 42 US Code 300aa-25 (See note to reviewer below)
Note to Reviewer Criteria for Record Selection 1) Record selection must be completely random the Provider must not know prior to the visit which records
will be reviewed 2) Patient must have been 0-19 years of age at the last visit (Note Records of 19-year-old patients may allow
you to see if VFC vaccines are being used beyond the allowable age)
Records are Compliant if they Contain ALL the Below Elements
bull Address of clinic where vaccine was administered bull Publication date of VIS bull Name of vaccine administered bull Name of vaccine manufacturer bull Date vaccine was administered bull Lot number bull Date VIS was given bull Name and title of person who administered the
vaccine
A Number of records reviewed
B Number of records that contain ALL required documentation elements
If fewer than 10 records are reviewed select the reason why Provider does not have 10 patient records with immunizations in last 12 months
[X] Follow-up isrequired if one ormore records do not meet requirements
Goal of this question Assess whether the site is documenting all required information in each patientrsquos medical record for every vaccine dose administered in accordance with the National Childhood Vaccine Injury Act
Resources bull Section 6 of the MnVFC Policies and Procedures Manual bull National Vaccine Injury Compensation Program (wwwhrsagovvaccinecompensation)
Question 33
3 Documentation Record Retention
Question 33 Is the provider able to demonstrate (preferred) or clearly describe how they maintain historical VFCeligibility documentation for three years
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers are required to maintain all records related to the VFC program for a minimum of three years (or longer if requiredby state law) and upon request make these records available for review VFC records include but are not limited to VFC screening and eligibility documentation billing records medical records that verify receipt of vaccine vaccine ordering records and vaccinepurchase and accountability records
Goal of this question Make sure the site understands they are required to keep all MnVFC screening documentation for at least three years either electronically or on paper This information should be available to you at the time of the visit and future visits
Resource bull Section 7 of the MnVFC Policies and Procedures Manual
Page 26 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 34
3 Documentation Borrowing Documentation
Question 34 Discuss borrowing practices with the provider to answer the questions below
Note to Reviewer bull To be considered ldquofully documentedrdquo documentation for each borrowed dose must include thefollowing information
Vaccine type borrowed Date the dose was administered Stock used (VFC or private) Reason appropriate vaccine stock was not used Patient name and date of birth Date dose was returned to appropriate stock
A Did the provider state that they had borrowed any vaccines (whetherdocumented or not) since the last VFC Compliance Site Visit
Yes No (If no skip to question 36)
B Are there any doses for which there is no documentation (ie provider hasindicated that doses were borrowed but cannot verify how many or why)
All doses are documented Some doses are not documented [X] No doses are documented [X] (if nodoses documented skip toquestion 36)
C Were all borrowed doses fully documented (See Note to Reviewer above) Yes No [X]
D Were all borrowed VFC doses either replaced or an order submitted to replacethe doses Yes No [X]
Review CDC Requirement
VFC providers are expected to maintain an adequate inventory of vaccine for VFC and non-VFC-eligible patients It is theresponsibility of the VFC provider to appropriately schedule and place vaccine orders VFC providers must also rotate stock to ensure timely use of short-dated vaccines Borrowing of vaccine between private and public inventories must be a rare unplanned occurrence and cannot serve as a replacement system for a VFC providerrsquos privately purchased vaccine inventory All instances ofborrowing must be properly documented reported and replaced
Goal of this question Assess vaccine accountability by verifying that children are receiving vaccine from the appropriate stock
Borrowing is when a fully insured child receives a dose of MnVFC vaccine or a MnVFC-eligible child receives a dose of private vaccine This should be a rare unplanned occurrence The site must document any borrowing of vaccine between stocks ideally on the VFC Borrowing Report Form If they are not currently using the form review it with them and encourage them to post it close to their vaccines It does not need to be sent to MDH but should be kept for 3 years and filed with their MnVFC documents to be reviewed whenever they have a regular or unscheduled (unannounced) site visit
Helpful information bull Understand and report on staffrsquos verbal (ie anecdotal) accounts of borrowing obtained during the visit Often sites do not know that what they do is considered borrowing or they think borrowing is acceptable and documentation isnrsquot needed so long as those vaccines are eventually replaced
bull Since sites using the replacement method only have one stock of vaccine they very rarely borrow bull This question asks for future follow-up in 6 months Make a note on your calendar and ask them to send you a copy of their borrowing reports for the previous 6 months with documentation of doses borrowed and replaced We will remind you if we donrsquot hear from you at the 6 month time frame Complete the Follow-up Form and attach the borrowing form
Resources bull Vaccine Borrowing Report on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfc formshtml)
bull Section 10 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 27
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 353 Documentation Borrowing Reasons
Question 35 Based on your discussion with the provider and a review of borrowing reports document the dosesborrowed for each reason and answer the questions below
Note to Reviewer bull Short-dated vaccines are doses that are likely to expire before they can be used bull Exchanging short-dated vaccines should only occur in practices that have a small number of private
patients
A Reasons for Borrowing a VFC Dose (Enter the number of _____ Private vaccine shipment delay (order placed on time but delay in shippingreceipt)
vaccine doses borrowed for each
reason in the spaces
_____ Private vaccine not useable on arrival (vials broken temperature monitor out of range) _____ Ran out of private vaccine between orders (provider orders not placed on time) [X]
provided) _____ Short-dated private dose was exchanged with VFC stock _____ Accidental use of VFC dose for a private patient (human error) _____ Replacement of private dose with VFC when insurance plan did not cover vaccine _____ OtherDocumented dose did not include reason for borrowing [X]
(Explanation Required) Reasons for Borrowing a Private Dose _____ VFC vaccine shipment delay (order placed on time but delay in shippingreceipt) _____ VFC vaccine not useable on arrival (vials broken temperature monitor out of range) _____ Ran out of VFC stock between orders (provider orders not placed on time) [X] _____ Short-dated VFC vaccine dose was exchanged with private dose _____ Accidental use of a private dose for a VFC-eligible patient (human error) _____ OtherDocumented dose did not include reason for borrowing [X]
(Explanation Required)
B Enter date range for instances of borrowing reviewed in the borrowing report Note If ldquoDate of earliest instancerdquo is not available use the date of the last VFC Compliance Visit If ldquoDate of last instancerdquo is not available use the date of thecurrent VFC Compliance Visit
Date of earliest instance
Date of last instance
C Does borrowing appear to be a routine practice Note To determine whether borrowing is a routine practice assess frequency of and repeating reasons for borrowing Examples Frequent accidental use of incorrect stock exchanging short-dated vaccines or issues with ordering and shipment
Yes [X] No
Goal of this question Determine the reasons why the site is borrowing vaccine
If sites are using the Vaccine Borrowing Report review the reasons for borrowing to help document borrowed VFC andor private doses If they have not been documenting borrowing on this report (or any other form) estimate their borrowing practices If you do not know the date range for their borrowing use the last site visit date to the current visit date The use of ldquootherrdquo as the reported reason for borrowing should be rare if ever and would require explanation and follow up
Helpful information bull Look to see if they routinely maintain insufficient amounts or types of vaccine to support their public and private patients that leads to borrowing
bull Pay attention to borrowing cases documented as ldquoaccidentalrdquo Repetitive accidental borrowing may indicate an issue with ordering processes or insufficient staff training
bull Borrowing is not a place to document wasted or lost doses bull The time period of the borrowing may give you clues about the root cause Were the borrowed doses concentrated in a short period or spread out across several months or a year Are all vaccine types being borrowed or just one
bull If borrowing seems to be an issue discuss vaccine management ordering procedures
Resources bull Vaccine Borrowing Report on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfc formshtml)
bull Section 10 in the MnVFC Policies and Procedures Manual
Page 28 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 36
3 Documentation Vaccine Management Plan
Question 36 Physically review the providerrsquos Vaccine Management Plan to answer the question below
A Does the provider have a Vaccine Management Plan Yes No [X] (If no skip to question 37)
B Does the plan list the current Immunization Manager Vaccine Coordinator andback-up
Yes No [X]
C Does the plan address proper vaccine storage and handling practices Yes No [X]
D Does the plan specify vaccine receiving procedures Yes No [X]
E Does the plan contain procedures for what to do with vaccine in the event of an emergency
Yes No [X]
F Does the plan contain procedures for vaccine ordering Yes No [X]
G Does the plan address inventory control (example stock rotation) Yes No [X]
H Does the plan address how to handle vaccine wastage Yes No [X]
I Does the plan address staff training and documentation on vaccine managementstorage amp handling
Yes No [X]
J Does the plan contain a review date that falls within the last 12 months Yes No [X]
K Has the plan been signed by the individual responsible for its content Yes No [X]
Review CDC Requirement
VFC providers must develop maintain and implement a Vaccine Management Plan for routine and emergency vaccinemanagement The plan must contain the current Vaccine Coordinator and back-up proper storage and handling practicesshipping and receiving procedures emergency procedures procedures for vaccine ordering inventory control (eg stock rotation)how to handle vaccine wastage and staff trainingdocumentation on vaccine management storage and handling The plan must bereviewedupdated annually or more frequently if changes occur A ldquoreview daterdquo and signature are required on all plans in order tovalidate that they are current
Goal of this question Evaluate the sitersquos plan for vaccine management It is especially important that they have a plan for emergency management of their vaccine in the case of equipment failure or power outage Encourage all sites to read and sign the MnVFC Policies and Procedures Manual and complete the emergency plan or be able to show you a plan of their own
If the provider is not able to physically show you the plan at the time of the visit or if the recorded review date is not within the last 12 months you must mark that this requirement is unmet The Vaccine Management Plan is important in times of emergency and it should be easy to access by any staff member at any time Encourage them to post the plan and put a copy with the packing supplies
Helpful information bull Encourage the site to fill in the ldquoImmunization Managerrdquo and ldquoVaccine Coordinatorrdquo fields in the
MnVFC Policies and Procedures Manual for their own referencebull The emergency plan in the manual can be reviewed from last year and included in this yearrsquos manual (with an updated signature and date) if there have not been any changes
bull If information in the plan is outdated site staff will not be well equipped to safely manage vaccines in the event of a power-outage or other emergency situation
bull If their institutional policy is only reviewed and updated every 3-4 years (as many are) the staff may need to sign the MnVFC Polices and Procedure Manual to meet this requirement
Resource Routine Vaccine Management Plan and Emergency Vaccine Management Plan in the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 29
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 37
3 Documentation VIS amp VAERS
Question 37 Review the providerrsquos Vaccine Information Statements (VISs) and discuss providerrsquos VAERS process toanswer the questions below
A Does the provider have readily available up-to-date VISs for all ACIP-recommendedvaccines relevant to the populations it serves
Yes No [X]
B Does the provider make a VIS available for patientsparents before eachvaccination
Yes No [X]
C Does the provider know how and when to report clinically significant adverseevents using VAERS
Yes No [X]
Review CDC Requirement
VFC providers are required to distribute the current Vaccine Information Statements (VIS) each time a vaccine is administered and maintain records in accordance with the National Childhood Vaccine Injury Act (NCVIA) which includes reporting clinicallysignificant adverse events to the Vaccine Adverse Event Reporting System (VAERS) For a list of current VISs visit CDCrsquos Vaccine Information Statements (httpwwwcdcgovvaccineshcpvis) website
Gal of this question Ensure the site has the most current VISs and is giving them to each patientparent before administering the vaccine in compliance with the federal law Parents must be educated about the vaccine their child will receive and be aware of possible contraindications and side-effects in order to make well-informed decisions about their childrsquos health
Helpful information bull Ask to see the sitersquos VISs to determine if they have an active protocol for giving VISs to parents Review to make sure they are current Ask if they know where and how to report vaccine adverse events
Resources bull Section 3 in the MnVFC Policies and Procedures Manual bull CDC Vaccine Information Statements (wwwcdcgovvaccineshcpvisindexhtml) Site may sign up for email updates for the current list of VIS publication dates for the most up-to-date version
bull IAC Itrsquos Federal Law You must give your patients current Vaccine Information Statements (wwwimmunizeorgcatgdp2027pdf)
bull VAERS (httpsvaershhsgovindex)
Question 38
3 Documentation Anaphylaxis protocol
Question 38 Does the site have an anaphylaxis protocol which is clearly posted near the emergency kit
Answers (Choose one)
Yes No [X]
Review CDC Requirement
An anaphylaxis protocol must be clearly posted in the area where vaccines are administered
Goal of this question Make sure site is prepared for a severe allergic or anaphylactic reaction to a vaccine
Resources bull Section 11 in the MnVFC Policies and Procedures Manual bull IAC protocols Child and Teens (wwwimmunizeorgcatgdp3082apdf) and Adults (wwwimmunize orgcatgdp3082pdf)
Page 30 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
i
i i i - li i i i i i l
Section 4 Storage amp Handling Per Unit The goal of this section is to assess vaccine storage
2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet practices in each unit at the site MnVFC PIN ___________________
The 2017 MnVFC Storage amp Handling Per Unit Answer Sheet is a worksheet to document the answers to the questions in this section for each unit (combination or stand-alone) Fill in the answers to the questions in Section 4 on the answer sheet not in the questionnaire
The answer sheet has an abbreviated form of each question If you need further information on that question refer back to the full questionnaire Also if you find an area where the site is not meeting the requirements you will need to go back to that question on the 2017 MnVFC Site Visit Questionnaire to complete ldquoActions if Non- compliantrdquo section including the root cause analysis and follow-up sections If there is a problem in more than one unit make a note on the questionnaire which unit you are referring to in the Notes section
Important You must fully assess any unit that may be used to store VFC vaccines even if there are no VFC vaccines there on the day of the visit If there are no vaccines and the site is not documenting twice a day temperatures discuss the need to ensure the unit is maintaining stable temperatures by monitoring for one week before placing vaccines in the unit
Quest on number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
for the freezer and e co umn
Temperature Monitoring Dev refr gerator f the un
ce Quest ons Quest ons 4 3 4 7 must be answered separate y t s a combo Be sure to document responses n the appropr at
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
44D Data downloaded and reviewed routinely (eg weekly)
Yes No [O]
Yes No [O]
45A Certificate of Calibration Testing Yes No [X]
Yes No [X]
45B Date of calibration
45C Date certificate expires [X] Follow-up is required if expired [X] Follow-up is required if expired
45D Certificate contains all necessary items
Yes No [X]
Yes No [X]
46 Probe properly placed Yes No [X]
Yes No [X]
47A Two temperature readings per day
Yes No [X]
Yes No [X]
47B Time date and name (or initials) for each reading
Yes No [X]
Yes No [X]
47C Current temperature and minmax temperatures (if
Current ________deg Minimum ________deg Maximum _deg
Current ________deg Minimum ________deg Maximum _deg
Sections 5 and 6 contain questions about storage and handling site wide and inventory It is helpful to keep those questions in mind as you assess the individual storage units Think about dorm-style units expired vaccine vaccine supply room for vaccine stocking all the recommended vaccines and separation of stock if appropriate
NOTE The sections that follow require reviewers to validate responses by looking at vaccine storage units temperaturemonitoring equipment and the vaccine inventory inside a unit bull For section 4 use a separate Storage amp Handling Per Unit Answer Sheet for each unit to document the findings (combination
units using both sections can be documented on the same answer sheet) bull When an unmet requirement is identified return to this questionnaire to complete the ldquoActions if Non-compliantrdquo section for
that question bull After you complete one answer sheet for each unit return to the questionnaire to complete sections 5 and 6 using information
you gathered while assessing the units The questions in sections 5 and 6 (Storage amp Handling Site-Wide and Inventory) are notunit-specific but do require that the response be based on a thorough assessment of all the providersrsquo units
4 Storage amp Handling Per Unit
Description On the Storage amp Handling Per Unit Answer Sheet place a name that will allow you or someone else from your program to easily identify this unit in the event of follow-up We recommend using Brand + Location(example Samsung - Room 123) Save each Storage amp Handling Per Unit Answer Sheet with the Brand + Location in the file name
(example SamsungRoom123doc)
IPI Advisor Manual | February 2017 Page 31
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 41
4 Storage amp Handling Per Unit Storage Unit Build amp Use
Question 41 Below select the build and use of the vaccine storage unit you are assessing
Note to Reviewer Dorm-style units Do not add dorm-style units here Dorm-style units will be addressed in section 5 Units storing only private stock You must review these storage units even if they contain only private stockat the time of the visit because that vaccine could be administered to VFC patients
A What type of unit is this A Stand-alone B Combination
B Select use if stand-alone A Freezer B Refrigerator
Select use if combination A Use both sections to store vaccine B Use freezer section only to store vaccine C Use refrigerator section only to store vaccine
Goal of this question Identify the unit you are evaluating The description asks you to create a unique name for this unit so that you will be able to identify the same unit in future site visits Put this description on the top of the answer sheet (ie make and location)
Helpful information bull A stand-alone unit is either a refrigerator or a freezer It does not have both sections in the unit bull If there is a combination unit note if the site uses both the refrigerator and freezer or only one section of the unit to store vaccines CDC does not recommend the use of either section or the freezer section only of combination household units
bull If your site utilizes the separate stock method of vaccine management you must review storage units even if they contain only private stock at the time of the visit because there is a chance that those vaccines could be administered (borrowed) to VFC-eligible patients
Page 32 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 424 Storage amp Handling Per Unit CDC Recommended Storage Units
Question 42 Below document the grade of the vaccine storage unit you are assessing
Note to Reviewer Pharmaceutical Also called ldquopurpose-builtrdquo these units are designed by the manufacturer specifically tostore vaccines or other biological materials Commercial Although usually intended to store food and beverages commercial units are often larger and more powerful than the household units found in most homes Though these units are intended to meet thehigher demands of larger facilities these units are not specifically built for the storage of biologicalmaterials Household (non-commercialdomestic) These units are usually smaller than commercial units and areintended for use in small offices and in homes ndash typically for food storage However just like commercialunits they are not designed specifically for the storage of biological materials Such units are usually available in common home supply stores
Answers (Choose one)
Select grade A Pharmaceutical B CommercialHousehold
[O] CDC does not recommend the use of both sections or the freezer section only of combination commercialhousehold units
Review CDC Recommendation
CDC recommends the following vaccine storage unit types (in order of preference) pharmaceutical grade stand-alone orcombination units (preferred) householdcommercial stand-alone units householdcommercial combination units using therefrigerator section only
Goal of this question Assess the grade and type of each storage unit bull Pharmaceutical grade units may be stand-alone or combination units that are often metal may have glass in the door for viewing inside often have an external digital temperature display and are manufactured by medical companies
bull Commercial or household units often look like your kitchen appliance have vegetablemeat drawers in the unit and are manufactured by household appliance companies
bull Occasionally you might find a medical grade unit which is usually a commercialhousehold unit with a lock and 3-prong plug These are still considered household units because of their ability to maintain proper temperatures and air flow Studies show that household stand-alone units are better able to maintain consistent temperatures than their combination counterparts Combination household units used to store vaccine in both sections of the unit is no longer recommended and may be prohibited in the future Combination household storage units that are having difficulty maintaining a cold enough freezer temperature and a warm enough refrigerator temperature should be replaced or a separate stand-alone freezer should be purchased
For frozen vaccines the most cost effective solution is for the site to purchase a small stand-alone freezer The site may need time to budget for a stand-alone storage unit
Resources bull Replacing Combination Household Units Tip Sheet on IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml)
IPI Advisor Manual | February 2017 Page 33
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 434 Storage amp Handling Per Unit Temperature Monitoring Device in the Unit
Question 43 Determine whether there is a temperature monitoring device in this section of the storage unit andanswer the questions
A Is there a temperature monitoring device in this section of thestorage unit
Yes No [X] (If no skip to question 47)
B Who is responsible for supplying the temperature monitoring device in this section of the storage unit Provider
Review CDC Requirement
Certificates of calibration testing provide confidence that the temperature monitoring device is measuring temperaturesaccurately All units storing VFC vaccines must have a calibrated temperature monitoring device with a current and valid certificateof calibration testing All certificates must contain modeldevice name or number serial number date of calibration testing (report or issue date) and Instrument Passed testingInstrument in Tolerance (Recommended uncertainty = +-05ordm C (+-1ordm F))
Goal of this question Assess whether there is a temperature monitoring device in the unit If the unit is not being monitored at all call MDH at 651-201-5522 for guidance
Helpful information bull This question does not ask whether the temperature monitoring device is working or the characteristics of the device These issues will be addressed later in the questionnaire
bull For part B the provider is always responsible for supplying the temperature monitoring device Even if their thermometer or data logger was originally from MDH it is their responsibility to ensure it is functional and calibrated
Resources bull Section 8 in the MnVFC Policies and Procedures Manual
Page 34 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 444 Storage amp Handling Per Unit CDC Recommended Temperature Monitoring Device
Question 44 Assess the temperature monitoring device in this section of the storage unit to answer the questionsbelow
A Is the temperature monitoring device a continuous monitoring and recordingdevice (eg data logger)
Yes No [O] (Skip D)
B Does the temperature monitoring device have a probe in buffered material Yes No [O]
C Does the temperature monitoring device have a digital display that can beeasily read from the outside of this unit
Yes No [O]
D Is data downloaded and reviewed routinely Yes No [O]
Review CDC Recommendation
As of Jan 1 2018 all VFC providers must use continuous temperature monitoring devices (eg data loggers) to monitor vaccinesthat will be administered to VFC-eligible children Routine review and accessibility of temperature data is critical for determining whether vaccine has been properly stored and for assessing usability of vaccine that was involved in a temperature excursion Tomeet VFC Program requirements the device must also be equipped with bull A temperature probe bull An active temperature display that can be easily read from the outside of the unit bull The capacity for continuous monitoring and recording capabilities where the data can be routinely downloaded
The following are additional recommended features for these devices bull Alarm for out-of-range temperatures bull Current minimum and maximum temperatures display bull Low battery indicator bull Accuracy of +- 1degF (05degC) bull Memory storage of at least 4000 readings bull User programmable logging interval (or reading rate) recommended at a maximum time interval of every 30 minutes bull Use of a probe that best reflects the temperature of the vaccine (such as a buffered probe)
Goal of this question Assess the temperature monitoring device in the storage unit Note that these are all recommendations not requirements at this time
This is a great teaching opportunity for sites who do not currently have a continuous temperature monitoring device Beginning Jan 1 2018 all units that store MnVFC vaccine will be required to have a continuous temperature monitoring device (ie a data logger or a continuous temperature monitoring system) Unlike a minmax thermometer a continuous temperature monitoring device provides detailed information on all temperatures recorded at pre-set intervals For excursions it can provide information on when a temperature went out-of-range for how long and what the temperatures were This is essential information that vaccine manufacturers need to know to assess the viability of the vaccine following an excursion
Helpful information bull Sites are required to monitor and record temperatures twice daily however temperature excursions can easily occur in the 12 hours or longer between readings Continuous temperature monitoring can help manufacturers determine vaccine viability
bull Continue to encourage sites to document and evaluate minimum and maximum temperatures the storage unit reached since the last reading and respond appropriately to out-of-range temperatures
IPI Advisor Manual | February 2017 Page 35
The 2017 MnVFC Site Visit Paperwork Chapter 4
bull It is recommended that sites download and review data weekly Discuss with sites that reviewing temperature monitoring device data also includes responding appropriately if they identify out-of-range temps
bull There is sometimes confusion about the difference between a data logger and a continuous temperature monitoring system Here are some differences
Data Loggers Continuous Monitoring Systems Have an external display similar to thermometers May or may not have an external display Have a detachable probe Probe is usually attached to transmitter Need to be plugged into the computer or cradle to download information on a regular schedule
Wirelessly sends data to computer system
Create a file of data that needs to be saved on the computer
Data is stored within the system not a separate file
Doesnrsquot allow documentation of twice a day temperature checks in the file
May allow documentation of twice a day temperature checks within the system
More about the 2018 requirement for a continuous temperature monitoring device
Required Features bull The continuous temperature monitoring device must have Continuous monitoring and recording capabilities to track and record temperatures over time The capacity to routinely download temperature data to a computer (recommended at least weekly) or wirelessly transmit data Detachable probe in a bottle filled with a thermal buffer (eg bio-safe glycol) if the data logger needs to be detached in order to download data Active temperature display
Recommended Features bull MnVFC recommends continuous temperature monitoring devices with Alarm for out-of-range temperatures Accuracy within +-1degF (+- 05degC) Low battery indicator Display of current minimum and maximum temperatures Memory storage of at least 4000 readings User programmable logging intervals (eg the user can set how often the device records the temperature)
Note that these are all currently recommendations not requirements yet
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Page 36 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 45
Goal of this question Ensure the temperature monitoring device is properly calibrated The certificate of calibration testing means that the device has been tested and it is accurately measuring temperatures within established testing limits The certificate of calibration ensures that the device meets all the required components
Helpful information bull The provider is always responsible for having a current certificate of calibration (or copy) on-site
bull To be considered ldquovalidrdquo a certificate of calibration must contain these required elements Modeldevice name or number Serial number
4 Storage amp Handling Per Unit Certificate of Calibration Testing
Review CDC Requirement
Certificates of calibration testing provide confidence that the temperature monitoring device is measuring temperaturesaccurately All units storing VFC vaccines must have a calibrated temperature monitoring device with a current and valid certificateof calibration testing All certificates must contain modeldevice name or number serial number date of calibration testing (report or issue date) and Instrument Passed testingInstrument in Tolerance (Recommended uncertainty = +-05ordm C (+-1ordm F))
Question 45
Note to Reviewer
A
B
C
D
E
Review the certificate of calibration testing for the temperature monitoring device in this section of the storage unit and answer the questions below
bull How to determine certificate of calibration testing expiration date 1) Identify the certificate issuecalibration date 2) Apply the Immunization Program-required frequency for calibration testing Example If the
issuecalibration date is 12312013 and Immunization Program policy requires testing every twoyears the expiration date is 12312015
bull Certificates must include all of the below bull ModelDevice Name or Number bull Serial Number bull Date of Calibration Testing (Report or Issue Date) bull Instrument Passed testing (Instrument in Tolerance)
Is there a certificate of calibration testing for the temperature monitoring Yes device in this section of the storage unit No [X]
What is the date of calibration for the temperature monitoring device in this section of the storage unit
What is the certificatersquos date of expiration based on ImmunizationProgram policy (See note to reviewer to determine expiration date) [X] Follow-up is required if
certificate is expired
Does the certificate contain all the necessary items listed in the Note to Yes Reviewer No [X]
Who is responsible for supplying the current and valid certificate of Provider calibration for this temperature monitoring device
Date of calibration testing (report or issue date) Note If there is no expiration date the certificate expires 2 years from the date of calibration Whether the instrument passed or failed testing (or instrument in tolerancenot in tolerance)
bull Recommended element Documented uncertainty of +- 1degF [05degC]
If these elements are present the certificate is considered valid If the certificate contains information about the recommended element or the entity that issued the certificate that is helpful but not required
To determine if a certificate of calibration testing was issued by an appropriate entity check to see if the certificate indicates one or more of these items (this is the wording used to help sites evaluate if their calibration is accurate but is not required on the certificate itself to be considered valid)
bull Conforms to ISO 17025 bull Performed by an ILACMRA Signatory body accredited laboratory You can review this list of the ILAC MRA and Signatories (httpilacorgilac-mra-and-signatories)
bull Traceable to the standards maintained by NIST bull Meets specifications and testing requirements for the American Society for Testing and Materials (ASTM) Standard E2877 tolerance Class F (le 05 degC) or better
bull Includes reference to another acceptable accuracy validation method such as comparison to other traceable reference standards or tests at thermometric fixed points
Note CDC recommends that certifications be issued for the entire monitoring unit (detachable probe data logger etc) and not individual certificates for each component
IPI Advisor Manual | February 2017 Page 37
The 2017 MnVFC Site Visit Paperwork Chapter 4
For 45 E the provider is always responsible for supplying the current and valid certificate of calibration for a temperature monitoring device
bull Tip If the temperature monitoring device has a sticker on the back with the calibration date the site can usually call the company who calibrated the device and get a copy of the certificate if they donrsquot have one
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 46 4 Storage amp Handling Per Unit Probe Placement
Question 46 Is the probe properly placed in this section of the storage unit
Note to Reviewer ldquoProperlyrdquo means that the probe in a commercial or household unit is placed in a central area of the unitdirectly with the vaccines Probes should not be placed in the doors near or against the walls close to vents or on the floor of the unit The only allowable exemption related to this requirement is for providerswho have pharmaceutical storage units (built for vaccine storage) that have either (1) a built-intemperature monitoring device OR (2) a dedicated port for the probe that dictates the placement of theprobe
Answers (Choose one)
Yes No [X]
Review CDC Requirement
The probe must be placed in a central area of the section of the storage unit directly with the vaccines in order to properly measurevaccine temperature The probe should not be placed in the door near or against the walls close to vents or on the floor of theunit For pharmaceutical units with a built-in temperature monitoring device or a dedicated port for a probe that is not in thecenter of the section of the storage unit consult your Immunization Program for guidance on placement
Goal of this question Make sure the temperature monitoring device is in the best location to accurately measure the temperature of the vaccines stored in the unit
Helpful information bull The probe of the temperature monitoring device should be placed directly with the vaccines in the middle of the unit The ONLY allowable exception is for pharmaceutical storage units that have either a built-in thermometer or a dedicated port for the probe that indicates placement of the probe
bull Temperatures can vary within the unit especially household units bull Call MDH at 651-201-5522 if you have questions
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Guide (wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml)
Page 38 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 474 Storage amp Handling Per Unit Temperature Documentation
Question 47 Review the temperature documentation over the past three months for this section of the storage unit todetermine whether the provider has a process in place for properly documenting temperatures twice aday Answer the questions below
A Are there two temperature readings recorded for this section of the storage unit per day
Yes No [X]
B Is there a time date and name (or initials) recorded for each reading Yes No [X]
C What is the current temperature and minmax temperatures (if available) inthis section of the storage unit Use the reviewerrsquos thermometer if the providerrsquos temperature monitoringdevice does not have a current valid certificate of calibration testing or the probe is not properly placed in this section of the storage unit
Current Temperature Minimum Temperature Maximum Temperature Fahrenheit Celsius
D Based on your review of the providerrsquos recent temperature documentationincluding the current temperature is this section of the storage unitmaintaining appropriate temperatures
Yes No [X] Not enough information [X]
Review CDC Requirement
Vaccines must be stored under appropriate temperatures as described in the package inserts at all times Acceptable temperature ranges vary by vaccine type and the range is 36deg F and 46deg F (2deg C and 8deg C) and for frozen vaccines the range is -58deg F and +5deg F (shy50deg C and -15deg C) Exposure to temperatures outside of those included in the package inserts could affect vaccine viability andultimately could leave children unprotected against vaccine-preventable diseases In order to maintain awareness of storage unittemperatures and ensure that vaccines are being stored at appropriate temperatures at all times VFC providers are required to monitor and document temperatures for all vaccine storage units at least twice a day Temperature documentation must contain (1) at least two temperature readings per day (2) the time and date of each reading and (3) the name (or initials) of the personwho assessed and recorded the readings CDC also recommends that VFC providers record the minimum and maximumtemperatures of each unit once each workday (preferably in the morning)
Goal of this question Ensure the temperature is being monitored twice daily is within the required range and documented correctly Use your thermometer to check the temperature if the sitersquos temperature monitoring devicersquos probe is not properly placed or there is not a current certificate of calibration Place your thermometer in the unit at the beginning of the visit to allow sufficient time to reach an accurate temperature The purpose of using your thermometer is to ensure the vaccine is being stored at the proper temperature not to ldquovalidaterdquo their reading
Question 47 D is an assessment question based on information you have learned during your visit You might answer ldquonot enough informationrdquo if the unit is new and they donrsquot have at least three months of data or if the unit is only used as overflow and they are inconsistent with temperature monitoring Mark ldquoNordquo if you have reason to believe the storage unit is not maintaining temperatures properly
Helpful information bull All sites must document temperatures twice a day every day the site is open even if they have a data logger or continuous monitoring system
bull Sites can document the information electronically with some continuous monitoring systems as long as it can show what the current temp is the date time and initials of the person checking ndash this needs to be someone at the site ndash not checking remotely or centrally for a large site or system The site must be able to produce these records during their site visit Reviewing these files can be a challenge due to large volumes and lots of paper
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Temperature Logs on Managing Vaccine (wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml)
IPI Advisor Manual | February 2017 Page 39
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 484 Storage amp Handling Per Unit Temperature Excursions
Question 48 In the event that a temperature excursion(s) occurred in this unit within the last three months requestand review documentation of actions taken to determine whether the provider has a process for properlyaddressing excursions Answer the questions below
A Were vaccines in this unit exposed to out-of-range temperatures in the lastthree months (including today)
Yes No (If no skip to question 49)
B Did the provider quarantine and label vaccines as ldquoDo not userdquo Yes No [X]
C Did the provider place vaccine in a unit where it can be stored under properconditions if applicable
Yes No [X]
D Did the provider contact the Immunization Program to report theexcursion
Yes No [X]
E Was the manufacturer contacted for documentation supporting theusability of the vaccine
Yes No [X]
Review CDC Requirement
The provider must document all excursions and actions taken including the following (1) Quarantine and label vaccines as ldquoDO NOTUSErdquo (2) Place vaccines in a unit where they can be stored under proper conditions (3) Contact the Immunization Program to report an excursion and (4) Contact the vaccine manufacturer to obtain documentation supporting the usability of the vaccine
Goal of this question Address any out-of-range temperatures (temperature excursions) identified in reviewing the last three months of temperature logs or during the site visit If there were any out-of-range temperatures did the site respond appropriately to the situation This is a great opportunity to discuss what to do in the event of an excursion The Clinicians Storage and Handling Mishap Checklist is in the IPI Site Visit information folder and is a good review of the process
Helpful information bull Sites need to know that an excursion does not automatically mean that exposed vaccines are non-viable or unusable Exposed vaccines must be quarantined (marked ldquoDo Not Userdquo) and stored under proper conditions until they have received information from vaccine manufacturers regarding the viability of the vaccine
bull Sites must inform MDH when an excursion occurs
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Clinicians Storage and Handling Mishap Checklist (wwwhealthstatemnusdivsidepcimmunize ipivaxchklstpdf)
Page 40 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 49
Goal of this question Ensure proper placement of vaccines in the storage unit
Note These are all recommendations (best practices) not requirements
Helpful information bull Store vaccine in the middle of the compartment two to three inches away from the coils walls floor and cold air vent The temperature near the floor and walls of the unit differs from that in the middle of the compartment and the cold air vent can freeze refrigerated vaccines
4 Storage amp Handling Per Unit Vaccine Placement
Question 49 Look inside the unit to answer the questions below
A Are vaccines placed in the middle of the unit with space between vaccinesand the sideback of the unit to allow cold air to circulate
Yes No [O]
B Are vaccines stored in their original packages Yes No [O]
C Are there water bottles (for refrigerators) or frozen water bottles (forfreezers) in the unit
Yes No [O]
D Are vaccines store in the doors vegetable bins under or near cooling ventsor on the floor of the unit
Yes [O] No
E Is food being stored in the unit Yes [O] No
Review CDC Recommendation
Vaccines should be stored in their original manufacturer (or CDC centralized distributor) packaging They should be placed in the middle of the unit with space between the vaccines and the sideback of the unit to allow cold air to circulate Vaccines SHOULD NOT be stored in the doors vegetable bins or floor of the unit or under or near cooling vents and there should not be any food inthe unit Water bottles (for refrigerators) or frozen water bottles (for freezers) should be placed throughout each storage unit inorder to (1) stabilize or extend temperatures during a power outage and (2) to serve as physical blocks preventing the placementof vaccines in areas of the unit that are at higher risk for temperature excursions (such as in doors vegetable bins floor ornearunder cooling vents)
bull Vaccines should be kept in their original packaging to Protect them from light Help prevent medication errors by making labels easier to read Provide a moisture barrier that serves as insulation in case of an out-of-range temperature power outage door left open or mechanical failure Simplify managing vaccine inventory
bull Store water bottles in the doors on the floor and near the cold air vent in the refrigerator and frozen water bottles in the freezer to help maintain a stable temperature if there is a power failure and when the door is opened frequently Too many water bottles in the door can prevent the door from closing tightly Mark water bottles ldquoDo Not Drinkrdquo
bull Do not store vaccine in the door or drawers of the refrigerator or freezer Vegetable bins and crisper drawers should be removed from refrigerators or used to store other medical supplies or water bottles
bull If vaccine is stored in a household combination refrigeratorfreezer The top shelf should not be used for storing vaccine because the cold air vent blowing from the freezer will freeze vaccine located there If you must use the top shelf of this type of unit place water bottles underneath the cold air vent to prevent vaccine from being stored there It is recommended that only the refrigerator be used for vaccine storage and a separate stand-alone freezer be used to store frozen vaccine
bull Must not store food or beverages in the refrigerator or freezer because frequent opening of doors can lead to temperature variations that may affect vaccine viability There is also a risk of contaminating vaccines
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Guide (wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml) bull Vaccine Storage Tip Sheet on IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml)
IPI Advisor Manual | February 2017 Page 41
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 4104 Storage amp Handling Per Unit Disconnection from Power Source
Question 410 Ask the provider to demonstrate what measures are taken to ensure that vaccine storage units are notaccidentally physically disconnected from the power supply Which of the following describes the measure(s) taken on this unit
Note to Reviewer bull Large hospitals and healthcare systems may not have the ability to demonstrate labels on plugs or circuitbreakers In such cases verify that the practice has a comprehensive policy and standard operatingprocedures in place to prevent the vaccine storage unit from being physically disconnected from thepower supply
bull While back-up generators may ensure power to the overall facility this question ONLY addresses thevaccine storage unit being accidentally disconnected from the power source either through the plug orthe circuit breaker
Answers A ldquoDo not disconnectrdquo labels on the plug (Choose all that B ldquoWarningrdquo label on the circuit breaker box
apply) C Hard-wired (ie built-in) and has a ldquoDo not disconnectrdquo label on thecircuit breaker box D Hospital or large health care system with a comprehensive written policyand standard operating procedures detailing measures taken to preventvaccine storage units from being accidentally disconnected from the powersupply E No acceptable measures for preventing accidental disconnection frompower supply [X]
[X] The response is non-compliant if only A only B or E is selected
Review CDC Requirement
VFC providers must take steps to protect the power source for all vaccine storage equipment by means of having clear warninglabels on both the plug and the circuit breaker associated with all vaccine storage units Large hospitals and healthcare systems canmeet this requirement by demonstrating that they have comprehensive policies and standard operating procedures to preventvaccine storage units from being physically disconnected from the power supply
Goal of this question Decrease the chance that a vaccine storage unit will be accidently unplugged or power will be turned off while vaccine is in the unit This question addresses only what measures the site has taken to ensure the storage unit is not physically disconnected from its power source
If the site uses labels on the plugs and circuit breakers perform a visual inspection to assess whether the way the stickers are positioned make it clear and obvious to anyone that these units are not to be disconnected
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Do Not Unplug and Warning stickers are included in the folder or available to order on the For
Professionals Order Form (wwwhealthstatemnusdivsidepcimmunizeordermathtml)
Note Once you have completed the 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet for each unit return to the questionnaire to complete sections 5 and 6
Page 42 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
- -
Section 5 Storage amp Handling Site-Wide Question 51
5 Storage amp Handling Site Wide Discussion of Cost amp Quantity of Vaccine
Question 51 Have a discussion with the provider about the cost and quantity of VFC vaccines they are responsible for annually Address the points listed in the note to reviewer below
Note to Reviewer bull Vaccine Shipped (Required) Share the cost of VFC vaccines shipped to the provider in the last calendaryear to make sure the provider understands the contribution made by the VFC Program to their practiceFor new providers who do not have ldquocalendar yearrdquo data share either the actual cost of their currentinventory or use the cost of 10 VFC doses of each of the ACIP-recommended vaccines (approximately $7000) to help estimate their annual cost
bull Storage amp Handling (Required) Make sure the provider understands the cost of vaccines for which they are responsible when they make decisions about purchasing recommended vaccine storage and temperature monitoring equipment
Answer I have discussed with the provider the cost and quantity of vaccines ordered in the previous calendar year
Goal of this question Inform sites of the quantity and value of vaccines that they receive as part of the MnVFC program Providers often donrsquot realize the value of the vaccine in their unit This information is included on your clinic list and on the one page site-specific information
Helpful information bull This discussion must occur and the box on the questionnaire must be checked bull If there isnrsquot actual vaccine value information available tell the site that one vaccine order that includes a box of each of the ACIP recommended vaccines costs approximately $7000
bull MDH may not have specific information for individual sites if they receive vaccine from a central warehouse or pharmacy For those sites MDH will give you numbers for the whole system so you can discuss system wide data as appropriate If individual site information is also included it is usually just varicella-containing vaccines that must be shipped directly to the site
Question 52
5 Storage amp Handling Site Wide Dorm Style Units
Question 52 Determine whether the provider has any dorm-style units on site and answer the questions below
Note to Reviewer A dormitory-style refrigerator is a unit that has both refrigerator and freezer compartments behind a singleexterior door Dorm-style units also have an evaporator plate (cooling coil) which is usually located insidean icemaker compartment (freezer) within the refrigerator
A Does the provider have any dorm-style units that are used at any time tostore vaccines
Yes [X] No (Skip to question 53)
B Does the provider have sufficient space in existing compliant vaccinestorage units to store all vaccines without use of the dorm-style unit at any time
Yes No [X]
Review CDC Requirement
Dorm- and bar-style units are prohibited for vaccine storage Vaccines stored in dorm-style units are considered non-viable and must be returned to the centralized distributor CDC recommends the following vaccine storage unit types (in order of preference)pharmaceutical grade stand-alone or combination units (preferred) householdcommercial stand-alone unitshouseholdcommercial combination units using the refrigerator section only
Goal of this question Ensure no vaccine is stored in dorm-style units even for short periods of time Encourage them to label any units ldquoNo Vaccine Storage Allowedrdquo Vaccine stored in these units is considered non-viable If a site is using a dorm-style unit call the MnVFC program (651-201-5522)
Resource Section 8 in the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 43
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 535 Storage amp Handling Site Wide Storage Unit Space Availability
Question 53 Does the provider have sufficient room across storage units to store current stock as well as anyadditional stock acquired during peak season without overcrowding
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have sufficient storage space to accommodate vaccine stock at the busiest time of year without overcrowding
Goal of this question Ensure that sites have sufficient space in their units to maintain vaccines at the busiest time of year Overcrowding of vaccine limits air circulation and affects the unitrsquos ability to maintain stable temperatures
Helpful information bull Look for signs of overcrowding such as vaccines that are pushed up against the wall bins that are overflowing or storage units that are full during non-peak seasons
Discuss immediate actions if the unit is overcrowded Move some of their vaccines order less vaccine more frequently (once per month preferably) andor purchase another storage unit for overflow
Resource bull Section 8 MnVFC Policy and Procedure Manual
Page 44 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 545 Storage amp Handling Site Wide Expired Vaccines
Question 54 Look in each unit Are there expired vaccines in any of the vaccine storage units at this site
Answers (Choose one)
Yes [X] No
Review CDC Requirement
Vaccines should be rotated weekly and when a new shipment comes in so that longer-dated vaccines are stored behind shorter-dated vaccines If vaccines expire they can no longer be stored in the same storage unit with viable vaccines They must be placedin a container or bag clearly labeled ldquoDo not userdquo and separated from viable vaccines to prevent inadvertent use Expired vaccinemust be returned to the centralized distributor within six months of expiration
Goal of this question Ensure there is no expired vaccine in any storage unit
Helpful information bull Sites can prevent their stock from expiring by rotating vaccines every week andor when a new shipment arrives Longer-dated vaccines are stored towards the back of the unit and shorter-dated vaccines are up front
bull Pay attention to vaccines that expire within the next three months Consider transferring vaccine that will expire soon to another MnVFC-enrolled site that will use the vaccine preferably a site close by It is the transferring sitersquos responsibility to arrange the transfer of the vaccine Be sure to complete the MDH Vaccine Transfer Record form and send it to MDH If they are having difficulty finding a location to accept vaccine contact MDH
bull This is a great opportunity to educate sites about the MDH Nonviable Vaccine Form and the process for returning vaccine The VFC program does get some credit for taxes and fees on vaccine that is returned to the distribution center
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MDH Nonviable Vaccine Form and MDH Vaccine Transfer Record on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfcformshtml)
IPI Advisor Manual | February 2017 Page 45
The 2017 MnVFC Site Visit Paperwork Chapter 4
- -
-
Question 555 Storage amp Handling Site Wide Back up Thermometer
Question 55 Does the provider have a readily available back-up thermometer with a current and valid certificate ofcalibration testing
Note to Reviewer ldquoReadily availablerdquo means that the thermometer is available to perform twice-a-day monitoring for a unit asrequired CDC recommends that the back-up thermometer be maintained on site
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have a readily available back-up thermometer with a current and valid certificate of calibration testing Toprevent the certificates of calibration testing of the primary and back-up thermometers from expiring at the same time the date of calibration testing (or issue date) of the back-up thermometer should be different from the date of calibration testing (or issue date) of the primary thermometer As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meetsVFC program requirements
Goal of this question Ensure sites have one calibrated back-up thermometer onsite that is readily available in the event that the temperature monitoring device in unit fails transportation of vaccine is needed or there are other unexpected circumstances
Helpful information bull As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meets VFC Program requirements
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 56 5 Storage amp Handling Site Wide Preparation of Vaccine
Question 56 When does this provider prepare vaccine for administration to the patient
Note to Reviewer For mass vaccination clinics if one type of vaccine is offered providers may pre-draw up to 10 doses Ifusing pre-filled syringes pre-drawing also means activating the syringe by removing the needle guard orattaching a needle
Answers (Choose all that
apply)
Prepare dose immediately before administration Pre-draw doses for upcoming patients (in a regular clinicpractice) [O] Pre-draw up to 10 doses (in a mass-vaccination clinic) Pre-draw more than 10 doses (in a mass-vaccination clinic) [O] Other [O]
Review CDC Recommendation
CDC recommends preparing vaccines immediately prior to administration in order to assure viability of vaccine and prevent vaccinewastage Vaccines that are not administered immediately are at risk of exposure to temperatures outside of the required rangewhich can affect vaccine viability and ultimately can leave children unprotected against vaccine-preventable diseases
Goal of this question Discuss proper timing and preparation of vaccine(s) for administration These are recommendations not requirements
Helpful information bull Educate staff on the importance of preparing vaccine immediately before administration Pre-drawing of vaccines may lead to concerns related to vaccine viability potency sterility and wastage
Page 46 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 6 Inventory Question 61
6 Inventory Inventory Comparison
Question 61 Visually inspect storage units to determine if existing supply of vaccines proportionately mirrorspopulations served Choose the most accurate statement below
Note to Reviewer bull CDC recommends that providers maintain a four-week supply of inventory bull For this question do not take into account vaccine types that the provider does not order Here simply
make sure that overall the vaccines in the providerrsquos storage units are available in sufficient amounts toserve their patient population
Answers (Choose one)
The current vaccine inventory proportionately reflects the populations identified Only public stock is insufficient [X] Only private stock is insufficient [X] Both public and private stock are insufficient [X] Site uses the replacement method but does not appear to have enough vaccine for their population [X] Other [X]
Review CDC Requirement
VFC providers must order and stock routine vaccines in accordance with their patient population in order to prevent missedvaccination opportunities Having sufficient amounts of all stocks prevents the inadvertent use of VFC vaccines for non-VFC-eligiblepatients and vice versa
Goal of this question Assess whether the site is ordering appropriate quantities of vaccine for the population they serve at their site
Helpful information bull If the site sees 30 percent private-pay patients and 70 percent VFC the stock in their storage units should reflect that proportion If you donrsquot know you can ask the site about their population
bull This is meant to be a general assessment so in a big site if they have only a small amount of vaccine that may indicate an issue with vaccine management
bull CDC recommends smaller more frequent orders (ie monthly) rather than large orders to minimize the amount of vaccine loss if an incident occurs during shipment or in the storage unit Sites should not order more frequently than once a month
bull Sites using the replacement method will only have one stock but it should appear to be large enough for their population
bull Only assess the vaccine types that the site currently stocks in their unit We know there are sites that do not offer all ACIP-recommended vaccines for various reasons That issue will be addressed in question 62
IPI Advisor Manual | February 2017 Page 47
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 626 Inventory ACIP Recommended Vaccines
Question 62 Review providerrsquos current inventory to answer the questions below
A Does the provider offer all routine ACIP-recommendedvaccines for their patient population
Yes (Skip to question C) No [X] Offers all except varicella because direct ship ofvaccine is unavailable from manufacturer
B Which routine vaccines are NOT being offered DTaP Hepatitis A Hepatitis B HIB HPV Influenza Meningococcal
MMR Pneumococcal Polio Rotavirus TdapTd Varicella
C According to Immunization Program Policy does theprovider make accessible all non-routine ACIP-recommended vaccines for those VFC patients whomeet the criteria for receiving them
Yes (Skip to question 63) No [X]
D Which non-routine vaccines are NOT being offered Pneumococcal polysaccharide vaccine (PPSV23) Meningococcal Group B (MenB) Other
Review CDC Requirement
VFC providers agree to comply with immunization schedules dosages and contraindications that are established by the Advisory Committee on Immunization Practices (ACIP) for the vaccines identified and agreed upon in the Provider Agreement UNLESS bull In the VFC providers medical judgment and in accordance with accepted medical practice the VFC provider deems such
compliance to be medically inappropriate for the child bull The particular requirements contradict state law including laws pertaining to religious and other exemptions The VFC program entitles children to the following vaccines DTaP Hepatitis A Hepatitis B HIB HPV Influenza MeningococcalMMR Pneumococcal Polio Rotavirus TdapTd and Varicella VFC providers are also required to ensure that VFC-eligible children have access to non-routine vaccines as needed
Goal of this question Assess if the site is offering all the ACIP-recommended vaccines for the population they serve and these vaccines are in stock on the day of the visit It is important that every MnVFC-eligible child that comes to a providerrsquos office for an immunization is vaccinated
Helpful information bull The Advisory Committee on Immunization Practices (ACIP) is a group of medical and public health experts that develops recommendations on how to use vaccines to control diseases in the United States
bull Specialty providers are not required to offer all routine vaccines but should provide the vaccines appropriate for their population
bull If the site does not offer all routine ACIP-recommended vaccines appropriate for their population check the ldquoNordquo box in Part A then check the appropriate box(es) in Part B for any vaccines not offered Please contact MDH as this situation offers us the opportunity to provide education to the site
bull For non-routine vaccines they must either be in stock or the site must have an alternative protocol in the routine management plan that ensures these children have access when applicable
Resources bull IAC Diseases and Vaccines (wwwimmunizeorgvaccines) bull CDC Advisory Committee on Immunization Practices (ACIP) (wwwcdcgovvaccinesacipindexhtml)
Page 48 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 636 Inventory Separation of Stock
Question 63 Observe how the provider differentiates stock in each storage unit to answer the questions below
A Is it clear which vaccines belong to public stock andwhich belong to private stock
Yes No [X] Not applicable replacement site
B Is it clear which vaccines belong to VFC stock andwhich belong to UUAV stock
Yes No [X] Not applicable replacement site Not applicable not UUAV-enrolled site
Review CDC Requirement
In order to ensure that VFC vaccines are only administered to VFC-eligible children VFC providers that serve both VFC and non-VFCshyeligible children must maintain their vaccine inventories in such a way that they can clearly differentiate public stock from privatestock as well as VFC from other public stock
Goal of this question Assess whether the site can distinguish between MnVFC vaccine and private vaccine If they participate in the Uninsured and Underinsured Adult Vaccine (UUAV) program they should also be able to distinguish between MnVFC stock and UUAV stock Some sites use labels bins boxes etc to differentiate their stock If it is not clear how the site differentiates their stock discuss vaccine management with the staff For follow-up call MDH to discuss doing a follow-up site visit
Sites using the replacement method will not have separate stocksmdashthis is an approved alternative method for keeping track of vaccine
Resource bull Section 10 of the MnVFC Policy and Procedure Manual
IPI Advisor Manual | February 2017 Page 49
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
MnVFC Site Visit Storage and Handling Per Unit Answer Sheet 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet MnVFC PIN ___________________
Question number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
Temperature Monitoring Device Questions Questions 43 47 must be answered separately for the freezer and refrigerator if the unit is a combo Be sure to document responses in the appropriate column
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
All the questions on the Site Visit Storage amp Handling Per Unit Answer Sheet have been discussed previously in section 4 of this manual Use this sheet to record information about all the units at the site visit You will need one sheet for each unit If it is a combination unit (either pharmaceutical or household) you can record both sections on one sheet If they have stand-alone units use one sheet for each unit Do not enter the answers to the questions in section 4 of the questionnaire
If you need more information about any of the questions refer back to the main questionnairemdashthe complete question additional guidance including notes to the reviewer and the CDC requirements are there Also if the site is not meeting the requirement you will go back to the questionnaire to complete the ldquoActions if Non-compliantrdquo section including the root cause analysis and follow-up sections
When you have completed the assessment of all the storage units remember to go back to the questionnaire to complete sections 5 and 6
Page 50 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
ndash
ndash
MnVFC Provider Follow-up PlanThe goal of the Provider Follow-up Plan is to communicate with the site all of the VFC requirements any unmet requirements found during your site visit and the timeline for completing the required action The left hand column is a box to check for ldquoUnmetrdquo requirements
Helpful information bull The form can be used to review what the site is doing well and what they need to work on
bull For requirements that have specific documentation that needs to be sent to you use the notes section
2017 MnVFC Provider Follow-up Plan Site _______________________________________________ MnVFC PIN ____________ Date of Visit ___________
Thank you for participating in this MnVFC compliance site visit Please review this visit summary including follow-up actions and timelines for completion Unmet MnVFC requirements and recommendations have a checked box next to them The goal of this plan is to support you with successfully implementing the program and improving access to vaccines for VFC-eligible children
Unmet Question VFC Requirements Section 1 Changes to Key Staff
Q12 Change in the Medical Director Immunization Manager Vaccine Coordinator or back-upKey Staff must be communicated to the immunization program by emailing healthmnvfcstatemnus Changes Notes
Q12 Key staff must complete the annual training on VFC program requirements and print theAnnual Training certificate of completion Documentation Required Action
Staff that have not completed the MnVFC online training must complete it and send acopy of the certificate to the reviewer Training can be found on the MnVFC website (wwwhealthstatemnusvfc) Due date 1 month
Notes
Unmet Question VFC Requirements Section 2 Eligibility
Q21 Provider staff must possess a working knowledge of all VFC eligibility criteria and use thoseVFC Eligibility criteria to screen children prior to administering VFC vaccines
Categories Notes
bull This form provides documentation needed for follow-up actions when you send your thank you email
The second to last page of the Provider Follow-up Plan has a summary of the MnVFC program recommendations These are to remind the site about best practices they may want to improve upon even though they are not yet requirements of the program For example you could discuss the recommendation about storage units if they currently have a combination household unit and are using both sections
The last section is for your signature and the person you met with In most sites it will be the immunization manager or vaccine coordinator who signs the form unless the medical director attended the site visit You keep the original copy and the site will need to keep a copy for themselves
To be completed by the site visit reviewer
I acknowledge that a VFC site visit was performed on __________________ (visit date) The follow-up plan which includes a list of all current VFC program requirements and recommendations assessed during the visit and any required follow-up actions was provided at the end of the visit
Site visit reviewer
Phone
Reviewer Signature Date
To be completed by the provider
I acknowledge that our practice took part in the VFC site visit noted above I understand the findings of the visit and any required actions that must be taken by our office in order to meet VFC program requirements
Medical Director (or designee) Name Title
Medical Director (or designee) Signature Date
IPI Advisor Manual | February 2017 Page 51
The 2017 MnVFC Site Visit Paperwork Chapter 4
After the Site Visit Send a thank you email highlighting the unmet requirements documents you need from the site to resolve the issue(s) and the date you need them Make sure to include the link to the Site Visit Survey (httpssurveyvovicicomseashxs=56206EE334CE0B14)
Please refer to Chapter 3 for more information about future follow-up required after the visit including forms and documentation
Resource bull Sample Thank You letter on IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml)
Chapter 5
IPI Advisor Resource List MnVFC Program 651-201-5522
MnVFC wwwhealthstatemnusvfc
bull Separate Stock and Replacement Method Policies and Procedures Manuals bull Online trainings bull MnVFC Announcements sign up to receive them via email bull Ordering MDH vaccine bull MnVFC forms Screening forms Reporting forms Others MDH Nonviable Vaccine Form MDH Vaccine Transfer Record and Vaccine Borrowing Report
bull MnVFC promotional materials bull Immunization Billing Guidance for MnVFC and Immunization Billing Guidance for MnVFC Replacement Sites Immunization Practices Improvement Program (IPI) wwwhealthstatemnusdivsidepcimmunizeipi
bull IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml) bull IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml) IPI Resource Folder Contents (wwwhealthstatemnusdivsidepcimmunizeipiipifolderpdf)
Minnesota Immunization Information Connection (MIIC) wwwhealthstatemnusmiic
bull MIIC regions and regional coordinators
Clinical Practice MDH Immunization Program wwwhealthstatemnusimmunize
Got Your Shots News wwwhealthstatemnusdivsidepcnewslettersgys
MDH Immunization Information for Health Care Providers wwwhealthstatemnusdivsidepcimmunizehcp
bull Got Your Shots A Providers Guide to Immunization in Minnesota bull Vaccine protocols bull Forms for tracking patient immunizations bull Immunization schedules for Health Care Providers Immunization Action Coalition (IAC) wwwimmunizeorg
bull Ask the Experts bull VISs (Vaccine Information Statements and translations) bull Administration screening questions bull Medical management of vaccine reactions bull Order form for Californiarsquos Immunization Technique DVD Best Practices with Infants Children and Adults
Page 52 IPI Advisor Manual| February 2017
IPI Advisor Resource List Chapter 5
CDC ldquoPink Bookrdquo wwwcdcgovvaccinespubspinkbookindexhtml
CDC Advisory Committee on Immunization Practices (ACIP) wwwcdcgovvaccinesacip
CDC Vaccines and Immunizations wwwcdcgovvaccines
VAERS reporting httpvaershhsgovindex
Storage and Handling Got Your Shots Providers Guide ndash Managing Vaccine wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml
MnVFC Guide to Temperature Monitoring Devices wwwhealthstatemnusvfc
MDH Clinicianrsquos Vaccine Mishap Checklist wwwhealthstatemnusdivsidepcimmunizeipivaxchklstpdf
MDH Vaccine Storage Guide wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml
CDC Vaccine Storage and Handling Toolkit wwwcdcgovvaccinesrecsstoragetoolkit
You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Vaccine manufacturer phone numbers wwwcdcgovvaccinespubspinkbookdownloadsappendicesFcontact-info-manufactpdf
IAC Checklist for Safe Vaccine Handling and Storage wwwimmunizeorgcatgdp3035pdf
IAC Donrsquot Be Guilty of These Errors in Vaccine Storage and Handling wwwimmunizeorgcatgdp3036pdf
Additional Resources Print materials from MDH ndash order forms wwwhealthstatemnusdivsidepcimmunizeordermathtml
Vaccine Education Center ndash Childrenrsquos Hospital of Philadelphia wwwchopeduservicevaccine-education-centerhomehtml
California Department of Public Health ndash Interactive training on vaccine administration and storage and handling handout on transporting vaccine and how to package wwwezizorg
IPI Advisor Manual | February 2017 Page 53
IPI Advisor Resource List Chapter 5
CDC vaccine price list wwwcdcgovvaccinesprogramsvfcawardeesvaccine-managementprice-listindexhtml
Vaccine Information Statements (VIS) wwwcdcgovvaccineshcpvisindexhtml
CEU Opportunities CDC Immunization Education and Training wwwcdcgovvaccinesedindexhtml
Immunization You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Page 54 IPI Advisor Manual| February 2017
- Introduction
-
- Welcome to the Immunization Practice Improvement (IPI) Program
- Contact Information
-
- Chapter 1
- Requirements to Participate in the MnVFC Program
- Vaccines for Children Program
- Chapter 2
- Reimbursement for MnVFC Visits
- Types of Visits
- Your MnVFC Clinical CoordinatorPlanner
- New IPI Advisor Training Requirements
- Your Role as an IPI Advisor
- Reasons MDH Would Do All or Part of a Visit
- Chapter 3
- Future follow-up
- Conducting the Visit
- Preparing for the Visit
- Information for the Visit
- Site Visit Checklist
- Scheduling the Visit
- Chapter 4
- After the Site Visit
- MnVFC Provider Follow-up Plan
- MnVFC Site Visit Storage and Handling Per Unit Answer Sheet
- Section 6 Inventory
- Section 5 Storage amp Handling Site-Wide
- Section 4 Storage amp Handling Per Unit
- Section 3 Documentation
- Section 2 Eligibility
- Section 1 Provider Details
- The Site Visit Reviewer Legend
- MnVFC Site Visit Questionnaire
- Required Paperwork for Site Visits
- Chapter 5
-
i i li
Site Visits Chapter 3
Information for the Visit2017 MnVFC Pre-Visit Worksheet Site name MnVFC PIN
Address
Medical director Email
Immunization manager Phone
Vaccine coordinator Phone
Vaccine coordinator back-up Email
IPI Site Vis t Preparat on Check st
The staff listed have completed the MnVFC online training and printed a certification of completion Immunization Manager Vaccine coordinator Vaccine coordinator back-up
Have a copy of the most recent provider agreement
Check if the above listed staff have changed since the provider agreement was completed
Check all of the vaccines administered at your site and list the corresponding publication date for each VIS you give to patients
DTaP _____________ Hepatitis A _____________ Hepatitis B _____________ Hib _____________ HPV _____________
Influenza _____________ MCV4 _____________ MMR _____________ MMR-V _____________ PCV13 _____________
Polio _____________ Rotavirus _____________ Tdap _____________ Varicella _____________
Non-Routine Vaccines Men B__________ PPSV23 _____________ Td _____________
Vaccine administration fee charged for MnVFC eligible children is $
Have a Vaccine Management and Emergency Plan that has been reviewed and dated within the last year
Have the borrowing reports if applicable for the last 12 months available at the visit
Have an anaphylaxis protocol that is clearly posted and reviewed annually
Send an appointment reminder email and the MnVFC Pre-Visit Worksheet to the MnVFC contact A sample letter and the MnVFC Pre-Visit Worksheet can be found on the IPI Advisor Site Visit Materials (wwwhealthstate mnusdivsidepcimmunizeipisvmaterialshtml) page You can request that the MnVFC Pre-Visit Worksheet and temperature logs be sent to you prior to the visit for your review
Contact the site by phone or email one or two working days before the scheduled visit to confirm your appointment This is also a good time to ask for directions and parking information if you are not familiar with the site
Preparing for the Visit Review the site visit paperwork to familiarize yourself with the questions For most of the questions there is a ldquoNote to the reviewerrdquo These notes give helpful tips about the information you are looking for when asking this question It contains the rationale for the question and which resources to provide to the site to support the rationale Some sections also require immediate on-site actionsmdashthings you must do while you are at the site and some require future follow up
bull Print copies the of site visit paperwork bull Site visit forms are available on the IPI Advisor Site Visit Materials (wwwhealthstatemnusdivs idepcimmunizeipisvmaterialshtml) page 2017 MnVFC Site Visit Questionnaire 2017 MnVFC Site Visit Storage amp Handling per Unit Answer Sheet (print one for each stand-alone andor combination storage unit at the site) 2017 MnVFC Provider Follow-up Plan (print two copies)
bull Review any previous site visit paperwork that is available You should check in with MDH staff after your visits if the site continues to have the same issues as past visits
bull Also be sure to bring Your thermometers If the sitersquos certificate of calibration is expired or the probe is not properly placed place your thermometer in the storage unit when you arrive and read the temperature just prior to reviewing the site visit findings
The MnVFC folder with additional immunization resources you wish to add (see chapter 5) and the Vaccine Storage amp Handling magnet (to order email healthIPIinquiriesstatemnus) A copy of the appropriate MnVFC Policies and Procedures Manual found on the MnVFC website (wwwhealthstatemnusvfc) Appropriate temperature logs (Celsius or Fahrenheit) Site information sheet that contains the quantity and value of the vaccine distributed to the sitesystem
Page 12 IPI Advisor Manual | February 2017
Site Visits Chapter 3
Conducting the Visit Education is a large part of the MnVFC site visit Often approaching this visit as an exchange of information with the site is more successful than a ldquoregulatoryrdquo visit Putting the staff at ease answering their questions and making a plan to address issues that arise during the visit is more helpful than a ldquopassfailrdquo attitude Education will usually consist of providing the rationale for the requirement referring to the requirement in the MnVFC Policies and Procedures Manual and providing resources to help address the situation Some questions will require additional follow-up to assure the site has corrected the issue(s) and is meeting the MnVFC requirement(s) This will be addressed further in the follow-up section
Completing the Paperwork
There are three documents that you must complete for the MnVFC site visit bull 2017 MnVFC Site Visit Questionnaire bull 2017 MnVFC Site Visit Storage amp Handling per Unit Answer Sheet (one for each storage unit) bull 2017 MnVFC Provider Follow-up Plan (two copies or you may ask them to make you a copy of the completed form for their records)
Answer the questions on the MnVFC Site Visit Questionnaire based on how things are when you arrive at the site If they correct the issue during the visit you will still mark it as an unmet requirement and document how it was addressed during the visit
The ldquoAnswerrdquo field will contain all the possible answer choices for this question For most questions answer choices will be followed by the markings below
bull Answer choices with no marking mean the site meets the CDC requirement bull Answer choices marked with an [X] indicate that this specific answer choice is non-compliant with a CDC requirement
bull Answer choices marked with an [O] indicate that this specific answer choice is not aligned with a CDC recommendation
If you marked the box with the [X] which is non-compliant with the CDC requirement conduct a root cause analysis to determine the reason for non-compliance Root cause analysis is an important component to a successful site visit It is used to identify the cause of the problem and help to resolve the issue There are several possible root causes that can be identified Choose only one root cause
bull Human cause Personal beliefsopinions Does not understand rationale of requirement Lack of concern for compliance
bull Organizational cause Competing job assignmentsworkload Lack of (insufficient) staff to perform required duties Budget limitations (for required equipment) Lack of (insufficient) training of staff Lack of (insufficient) processesprotocols
IPI Advisor Manual | February 2017 Page 13
Site Visits Chapter 3
Once identified the root cause should be documented in the questionnaire including a brief explanation of why you chose that cause This allows for follow-up with the site and a way to help find improvements to meet the unmet requirement Complete any immediate on-site action These often require providing education and resources for the site Mark the box for each action taken If you provide additional resources or information you can use the notes section to indicate the additional items
ldquoFuture follow-uprdquo are actions the site needs to take to meet the requirements of the program Wersquoll go over more specific information about the site visit questionnaire in Chapter 4
Performing the Site Visit
As you become familiar with the MnVFC program and develop a relationship with your sites you will develop a visit pattern that works for you Here is one possible sequence for conducting MnVFC site visits
bull When you arrive at the site if you have a business card it is helpful to provide it to the front desk staff person
bull When you meet with the immunization manager andor vaccine coordinator introduce yourself and explain the expectations for the visit
bull Ask to see the temperature monitoring device(s) It must have a current certificate of calibration and the probe must be properly placed in the unit If it does not meet the requirements place your thermometer in the unit at the beginning of the visit so that it has sufficient time to reach an accurate temperature by the time you complete your assessment of the storage units
bull 2017 MnVFC Site Visit Questionnaire Ask all of the questions You may have to modify the order of the questions based on what is best for the site When you get to the storage and handling section (section 4) use the answer sheet(s) to document the answers to the questions for each storage unit that stores vaccine (MnVFC or private) Do not write answers in the questionnaire unless there is an unmet requirement Be sure to ask if there is vaccine stored anywhere else at any time at this location This includes a co-located pharmacy If so these additional units will need to be assessed as well If the site has a combination refrigeratorfreezer household unit and is using both sections discuss with them the recommendation (and probable future requirement) to have a separate freezer Refer to MDH if they have further questions or need more information Be prepared to address any storage and handling mishaps that you may find A copy of the
Clinicianrsquos Vaccine Mishap Checklist is with your visit materials and the Emergency Response Worksheet is in the MnVFC Policy and Procedure Manual If you are unsure how to handle the problem call the MnVFC program at 651-201-5522 during or after the visit
Page 14 IPI Advisor Manual | February 2017
Site Visits Chapter 3
Ending the Visit bull Fill out the two copies of the 2017 MnVFC Provider Follow-up Plan (or ask them to make a copy once it is completed for their records) Indicate if they have not met the requirement by checking the box in the ldquoUnmetrdquo column If they are not meeting requirements check the required actions Review the plan with them reinforcing the positive things they are doing as well as reviewing the required follow-up action(s) Give the site a copy of the Provider Follow-up Plan Keep the signed copy of the Provider Follow-up Plan to submit with your paperwork Do not leave a copy of the Site Visit Questionnaire at the site
bull Let them know you will be sending a thank you email that will summarize the site visit Included in the email will be a survey link you would appreciate them completing regarding the visit
After the Visit bull Send the site a thank you email There is a template thank you letter on the IPI Advisor Site Visit Materials (wwwhealthstate mnusdivsidepcimmunizeipisvmaterialshtml) page Be sure you include the issues that you identified and the timeline for their completion as well as the good things you found at the visit In the template letter be sure to include the survey link The survey is very brief ndash a few questions and space to write comments
bull Either transfer your MnVFC Site Visit Questionnaire and MnVFC Site Visit Storage amp Handling per Unit Answer Sheet information to the fillable version or submit the handwritten form to MDH
Documentation of the Visit
Paperwork must be submitted to MDH within 10 days of the visit in order to meet the federal VFC programrsquos reporting requirements Do not wait to complete your follow-up before submitting the site visit paperwork
Send the following documents to MDH bull 2017 MnVFC Site Visit Questionnaire (includes the cover sheet) bull 2017 MnVFC Site Visit Storage amp Handling per Unit Answer Sheet (one for each unit) bull 2017 MnVFC Provider Follow-up Plan (original signed plan)
Submit site visit materials to bull Email healthIPIinquiriesstatemnus (preferred) bull Mail IPI Program Specialist
Immunization Practices Improvement Program Minnesota Department of HealthPO Box 64975St Paul MN 55164-0975
IPI Advisor Manual | February 2017 Page 15
Site Visits Chapter 3
Future follow-up Follow-up is an important component of the site visit It helps us ensure that the unmet requirements have been corrected The questionnaire has different time periods for follow-up depending on the question Do not wait to complete your follow-up before submitting the site visit paperwork
When you complete the Follow-Up Form make sure to keep a copy for yourself MDH also keeps track of follow-up required and will remind you if follow-up has not been completed by the deadline Most follow-up can be done with a phone call or email In-person follow-up is rarely required and should be discussed with MDH before scheduling a follow-up visit
All requirements that need follow-up are identified with a [X] on the site visit paperwork and are listed on the MnVFC Provider Follow-up Plan
bull Follow-up with the site to see how they have resolved the unmet requirements bull Document your follow-up on the Follow-Up Form available on the IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml) page If follow-up was done via letter or email a copy can be attached to the Follow-Up Form
bull Send your Follow-Up Form to MDH (healthIPIinquiriesstatemnus) with supporting documents and emails
bull If a site is not responding to your requests regarding follow-up contact your MnVFC clinical coordinatorplanner They can help with additional follow-up as needed
Page 16 IPI Advisor Manual | February 2017
Chapter 4 The 2017 MnVFC Site Visit Paperwork This chapter will go through the required MnVFC site visit paperwork with notes about information or resources to help the site address questions or issues that may arise during the visit
The MnVFC site visit paperwork is available on the IPI Advisor Site Visit Materials (wwwhealthstate mnusdivsidepcimmunizeipisvmaterialshtml) page
Please download the paperwork shortly before your visit as there may be updates and changes and this will be the most up-to-date version of the questionnaire We will send out a Workspace message with major changes
Required Paperwork for Site Visits bull 2017 MnVFC Site Visit Questionnaire bull 2017 MnVFC Storage amp Handling Per Unit Answer Sheet ndash one for each unit assessed during site
visit bull 2017 MnVFC Provider Follow-up Plan ndash with provider signature
Make sure to include the sitersquos PIN on all your paperwork Please complete and submit your site visit paperwork as soon as possible after your visit It may be helpful to schedule some time into your calendar to complete your paperwork in the days following your visit Once you have completed the post-visit follow-up send in the Follow-Up Form with documentation of the follow-up actions Please do not wait until you have completed your follow-up before sending in your initial paperwork
MnVFC Site Visit Questionnaire The questionnaire includes these six sections 1 Provider details 2 Eligibility 3 Documentation 4 Storage amp handling per unit 5 Storage amp handling site-wide 6 Inventory
IPI Advisor Manual | February 2017 Page 17
Page 18 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
The Site Visit Reviewer Legend The legend explains the formatting of the 2017 questionnaire This includes information that will be helpful in completing the site visit
Site Visit Reviewer Guide Legend
Section Number Content Area
Question number This area will always contain the text of the question
Note to reviewer The note to reviewer contains information that is necessary for properly asking and assessing responses tothe question above This may include definitions of terms requirement details and other helpful tips
Answers This field will contain all the possible answer choices for this question For most questions answer choiceswill be followed by the markings below
Answer choices marked with an [X] indicate that this specific answer choice is non-compliant with a CDC requirement Answer choices marked with an [O] indicate that this specific answer choice is not aligned with a CDC
recommendation
Review CDC RequirementRecommendation
This field will be populated with the CDC requirementrecommendation associated with the given question
Actions if Non-Compliant
Root Cause Analysis As part of the site visit reviewers are required to assess and understand the reasons why a provider office isnon-compliant with VFC program requirements ndash this is a root cause analysis Reviewers must choose theone root cause that they believe most contributes to the non-compliance Upon establishing the root causethe reviewer must provide a clear explanation of hisher findings
Immediate Action These are actions that CDC requires reviewers to take on site during the visit
Future Follow-up These are future follow-up actions (with designated due dates) that are required of the reviewer andorprovider to remedy non-compliance Reviewers must complete all follow-up in accordance with CDCestablished deadlines
Notes Information you want the VFC program to be aware of or that explains your answer in detail
bull Note to reviewer These are notes to help you understand what the question is asking for and to clarify things you might want to know when asking or rephrasing the question
bull Answers This section helps you to know when the answer does not meet the CDC requirement [X] or recommendation [O] Whenever an answer with a [X] is checked the ldquoActions if Non-compliant section must be completed The recommendations are usually good teaching points about best practices andor future requirements of the VFC program
bull Review the CDC RequirementRecommendation This section provides a specific outline of the requirement or recommendation to give you information to use in talking with the site staff
bull Actions if Non-Compliant This section describes what to do if the site is not meeting a requirement Root cause analysis This section asks you to probe beyond the surface to find what is driving the non-compliance It is intended to help uncover reasons for recurring non-compliance issues identify additional training needs and inform reviewer follow-up actions Select only one root cause and explain the particular circumstances in the space ldquoExplanation of root causerdquo line provided If there appear to be multiple issues choose the one that most contributes to the non-compliance and describe all factors in the explanation Immediate actions A list of actions to take during the site visit to address the issue Future follow-up A list of actions to take after the site visit by the set deadline
bull Notes This section can be used for notes to yourself or to MDH
IPI Advisor Manual | February 2017 Page 19
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 1 Provider Details Questionnaire Coversheet
The first page of the questionnaire collects the demographic information for the site You can use this page to help prepare for the visit Most of the demographic information about the site should be on the site-specific document you received with your clinic list You will validate that this information is current at the time of the site visit It also helps to know if this is a separate stock site or a replacement site before the visit so you can bring a copy of the appropriate MnVFC Policies and Procedure Manual
2017 MnVFC Site Visit Questionnaire Date of visit _____________ Date forms sent to MDH ______________
Site Information
Site name MnVFC PIN
Address Separate Stock Replacement
City ZIP County
Medical Director Email
Immunization Manager Phone
Vaccine Coordinator Phone
Vaccine Coordinator back-up Email
Point of contact Phone
Personnel at site visit
On this page bull The date of the visit and the date when you send these forms to MDH This information helps us track the timeliness of our review and data entry process
bull The vaccine management method used by the site (replacement or separate stock) bull The name and email of the medical director (ideally this is the person who signed the MnVFC
Program Provider Agreement)bull Contact information for the immunization manager vaccine coordinator vaccine coordinator back-up and point-of-contact for this visit The immunization manager vaccine coordinator vaccine coordinator back-up roles are
described in the MnVFC Policies and Procedure Manual The vaccine coordinator back-up may be the immunization manager or another staff person depending on the size of the site and available personnel The Point of Contact is the person you set up the appointment with signs the Provider Follow-
up Plan and receives the follow-up email This may be one of the people listed above
The Post Visit Steps section is a reminder to you about what needs to done after the visit The Education on Immunization Best Practices for Sites section reminds you to provide the resource folder to the site
Page 20 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 12
1 Provider Details Changes to Key Staff
Question 12 Ask the provider about changes to key staff to answer the questions below
A (Choose all that
apply)
At the time of the visit is the Medical Director the same individual that signed the ProviderAgreement and are the Immunization Manager and Vaccine Coordinator the same asthose last reported to the program
Yes No the Medical Director has changed No the Immunization Manager has changed No the Vaccine Coordinator has changed
B (Choose one)
Were all changes communicated to theImmunization Program according to yourprogramrsquos policy
Yes or no staff changes No [X]
C (Choose one)
Based on review of the trainingdocumentation have the current Immunization Manager Vaccine Coordinator and back-up completed all required training
Yes No [X]
Review CDC Requirement
All changes in key staff must be communicated to the Immunization Program in the manner and timeframe defined by theImmunization Program Key staff include the Medical Director or equivalent who signed the Provider Agreement the Immunization Manager Vaccine Coordinator and the back-up VFC providers are required to ensure that all key staff are fully trained on VFC program requirements at all times All training must be documented
Goal of this question Determine if there are new staff in key positions at the site and to make sure staff are properly educated about the MnVFC program A This information can help you determine the level of knowledge and experience the staff have with the MnVFC program Follow-up throughout the visit can be tailored for various levels of staff experience Likewise you may identify additional training needs for new staff
B When sites notify us of changes in key personnel we update their information in MIIC and on the clinic lists We also send the new staff information for completing the online training and direct them to read the appropriate MnVFC Policies and Procedures Manual If the answer to this part is no update the demographic area of the questionnaire and inform the staff that in the future they must notify the MnVFC program (via email or phone) if the immunization manager or vaccine coordinator changes Resource Section 12 of the MnVFC Policies and Procedures Manual
C Annual training must be verified by looking at the certificates for the online training If the answer to this part is no refer the staff to complete the appropriate MnVFC online training found on the MnVFC website (wwwhealthstatemnusvfc) for their program (separate stockreplacement) for the current year and send you a copy of the certificate within 30 days
Resource bull Sections 12 and 14 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 21
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 2 Eligibility Question 21
Goal of this Question Assess whether staff correctly understand which patients are eligible for the MnVFC program Screening ensures that eligible children receive the vaccines that they are entitled to receive under the MnVFC program and helps to prevent fraud or abuse of the program
Children 18 years and younger in these
categories can receive MnVFC vaccine at any enrolled site bull Uninsured bull Enrolled in a Minnesota Health Care Program (MHCP) Medical Assistance (MA) or MinnesotaCare bull American Indian or Alaskan Native
The following categories are considered underinsured and are only MnVFC-eligible at local public health (LPH) Federally Qualified Health Centers (FQHC) Rural Health Centers (RHC) Indian Health Services (IHS) and tribal health clinics
bull Has health insurance that does not cover one or more vaccines as can be the case with newly licensed vaccines that arenrsquot yet covered (MnVFC-eligible for non-covered vaccines only)
bull Has health insurance that caps vaccine coverage at a certain amount Once that amount is reached the child is MnVFC-eligible
Children with insurance that does not cover vaccines until a deductible has been met are considered to be fully insured and are not MnVFC-eligible
Helpful information bull Sites are not required to verify the patientrsquos response to the screening questions For example if a patient states they lost their insurance the site does not need to call the patientrsquos insurance company to confirm
If the site cannot correctly describe the eligibility categories provide educational materialsresources on MnVFC eligibility requirements
Resources bull Patient Eligibility Screening Record on MnVFC Forms (wwwhealthstatemnusdivsidepc immunizemnvfcformshtml)
bull Section 1 of the MnVFC Policies and Procedures Manual
2 Eligibility VFC Eligibility Categories
Question 21 Was the individual responsible for determining patient VFC eligibility able to explain all the factors(including age) that make a child eligible to receive VFC vaccines
A Patient is less than 19 years of age Yes No [X]
B Patient is Medicaid-eligible Yes No [X]
C Patient is uninsured Yes No [X]
D Patient is underinsured Yes No [X]
E Patient is American Indian Yes No [X]
F Patient is Alaska Native Yes No [X]
Review CDC Requirement
VFC providers must possess a working knowledge of all VFC eligibility criteria and use those criteria to screen children prior toadministering VFC vaccines In order to receive VFC vaccine a patient must be under the age of 19 and must be at least one of the following (1) Medicaid-eligible (2) Uninsured (ie child has no health insurance) (3) Underinsured (ie child has health insurancebut coverage does not cover any or certain vaccines ndash underinsured children may only receive VFC vaccines in FQHCRHC ordeputized VFC provider offices and only for vaccines not covered by insurance) and (4) American Indian or Alaska Native (AIAN)
Page 22 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 22
2 Eligibility Billing Practices
Question 22 Is the individualdepartment responsible for billing able to clearly explain how they bill for both the costof vaccine and the vaccine administration fee for each of the eligibility categories below
A Medicaid-eligible Cost of Vaccine Do not bill ndash provided by VFC Admin Fee Bill Medicaid
Yes No [X]
B Uninsured Cost of Vaccine Do not bill ndash provided by VFC Admin Fee If billing can bill patient
Yes No [X]
C Underinsured Cost of Vaccine Do not bill ndash provided by VFC through FQHCsRHCs or deputized providers only all other providers cannotprovide VFC vaccine to underinsured patients Admin Fee If billing can bill patient
Yes No [X]
D American IndianAlaska Native(AIAN)
Cost of Vaccine Do not bill - provided by VFC unless patient is fully insured and parent chooses to use insurance Admin Fee If patient is Medicaid-eligible bill Medicaid if billingand patient is uninsuredunderinsured can bill patient if parentchooses to use private insurance for cost of vaccine billpatientinsurance
Yes No [X]
E Do individuals responsible for billing have access to the results of eligibility screening toensure proper billing
Yes No [X]
Review CDC Requirement
VFC providers must adhere to proper billing practices for vaccine administration fees and clearly understand that VFC vaccine isprovided at no cost to both the VFC provider and eligible children At no time should billing occur for the cost of VFC vaccine Whenadministering VFC vaccine providers should never bill two different ldquopayersrdquo (ie patient Medicaid insurance) for the samevaccine administration fee amount For Medicaid-eligible children Medicaid should be billed for the vaccine administration fee Forall other VFC-eligible populations the patient may be billed within the stateterritory cap established by the Centers for Medicareand Medicaid (CMS) However patients cannot be turned away or reported to collections for inability to pay the administration fee
Goal of this question Determine if the staff correctly understand how to bill patients that are eligible for the MnVFC program Billing appropriately ensures that children can receive low cost immunizations and the site is in compliance with the VFC program
bull If there is any indication that sites could be billing insurance companies or parents for VFC vaccines this should be investigated further
bull Most sites in Minnesota will bill Medicaid with the SL modifier ndash which indicates this is a Medicaid claim
bull The main point is to ensure the site is not billing uninsured children for VFC vaccine and are not charging them more than $2122 per vaccine for the administration fee
bull Non-compliance is usually unintentional and may be resolved with some training In rare cases it could be a glimpse into a larger problem where a site is intentionally billing for financial gain
bull If you think the site is billing inappropriately it is the responsibility of the IPI advisor to report concerns to MDH staff for further assistance
Resources bull Immunization Billing Guidance for MnVFC (wwwhealthstatemnusdivsidepcimmunizemnvfc billingtipshtml) or Immunization Billing Guidance for MnVFC Replacement Method Sites (www healthstatemnusdivsidepcimmunizemnvfcreplacementbillingtipsrephtml)
bull Section 2 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 23
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 232 Eligibility Vaccine Administration Fee
Question 23 Document the actual vaccine administration fee charged to non-Medicaid VFC-eligible patients (confirmwith billing department)
Answers Fee $ [X] Follow-up is required if the provider charges more than the fee cap establishedby the Centers for Medicare and Medicaid (CMS) for your stateterritory ($2122)
Review CDC Requirement
The VFC providerrsquos vaccine administration fee for non-Medicaid VFC-eligible children must not exceed the stateterritory vaccineadministration fee cap established by the Centers for Medicare and Medicaid (CMS) For current fee caps refer to Medicaid Program Payments for Services Furnished by Certain Primary Care Physicians and Charges for Vaccine Administration Under theVaccines for Children Program Final Rule (httpwwwgpogovfdsyspkgFR-2012-11-06pdf2012-26507pdf)
Goal of this question Ensure that sites are not charging more than the federal allowable vaccine administration fee of $2122
bull The Centers for Medicaid and Medicare (CMS) establishes a maximum fee that sites can charge to non-Medicaid-eligible VFC patients in each stateterritory for vaccine administration Health Plans usually negotiate this fee with the site but Medicaid will not pay more
bull If a parent cannot pay the vaccine administration fee the patient cannot be turned away or reported to collections VFC-eligible children must be vaccinated regardless of their ability to pay
bull If the person with whom you are conducting the site visit does not know the exact fee charged to non-Medicaid VFC-eligible patients ask to speak to someone who can verify the exact amount
bull If they are charging more than $2122 for the administration fee ndash please contact MDH staff for help with addressing this situation
Resources bull Immunization Billing Guidance for MnVFC (wwwhealthstatemnusdivsidepcimmunizemnvfc billingtipshtml) or Immunization Billing Guidance for MnVFC Replacement Method Sites (www healthstatemnusdivsidepcimmunizemnvfcreplacementbillingtipsrephtml)
bull Section 2 of the MnVFC Policies and Procedures Manual
Page 24 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 3 Documentation Question 31
3 Documentation Eligibility Screening amp Documentation
Question 31 To answer the questions below the provider must clearly demonstrate the patient intake processReview a minimum of 10 records that contain an immunization visit within the last 6 ndash 12 months
Note to Reviewer Criteria for Record Selection 1) Record selection must be completely random and the provider must not know prior to the visit which
records will be reviewed 2) Patient must have been 0-19 years of age at the last visit (Note Records of 19-year-old patients may
allow you to see if VFC vaccines are being used beyond the allowable age) 3) Must review a mix of public and private-pay patients (if applicable)
A Does the provider have a process that ensures that patients are screened forVFC eligibility at each visit and that screening results are documented at each visit
Yes No [X] (If no skip question F)
B Does the providerrsquos process ensure that staff administering vaccine know which vaccine stock to select from prior to drawing the vaccine
Yes No [X]
C Number of records reviewed If fewer than 10 records are reviewed select the reason why Provider does not have 10 patient records with immunizations in last 12 months
D Do all records contain date of the immunization visit and patientrsquos date of birth Yes No [X]
E Do all records contain the patientrsquos specific eligibility status associated with thedate of the immunization
Yes No [X]
F Do any of the providerrsquos records contain any evidence that the patient received vaccine for which they were not eligible
Yes [X] No
Review CDC Requirement
VFC providers must screen for and document VFC eligibility at each immunization visit Documentation must include the date of the visit and the childrsquos specific eligibility category VFC providers must use screening results to ensure that only VFC-eligible children receive VFC vaccine and that administration fees are billed for as appropriate Eligibility status must be readily available to staff administering vaccine prior to selecting which vaccine stock to use
Goal of this question Ensure the site is screening for eligibility and documenting the eligibility category in the medical record
Review a minimum of 10 records from within the last 6-12 months where the patient received an immunization You must review a mix of public and private pay patients (if applicable)
Random selection is important If the staff have pre-selected records for review do not use and identify additional randomly selected records to review
Helpful information bull Discuss upgrading the electronic health record to make documentation of VFC eligibility screening a required field Documenting eligibility screening in the immunization field promotes better MIIC data
bull Q 31 B Sites using the replacement method of vaccine management only have one stock so you will answer ldquoYesrdquo to this question
Resources bull Patient Eligibility Screening Record on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfcformshtml)
bull Section 1 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 25
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 32
3 Documentation Vaccine Dose Documentation
Question 32 Review a minimum of 10 patient immunization records from the last six months (or 12 months ifnecessary) to assess compliance with documentation requirements set forth by Statute 42 US Code 300aa-25 (See note to reviewer below)
Note to Reviewer Criteria for Record Selection 1) Record selection must be completely random the Provider must not know prior to the visit which records
will be reviewed 2) Patient must have been 0-19 years of age at the last visit (Note Records of 19-year-old patients may allow
you to see if VFC vaccines are being used beyond the allowable age)
Records are Compliant if they Contain ALL the Below Elements
bull Address of clinic where vaccine was administered bull Publication date of VIS bull Name of vaccine administered bull Name of vaccine manufacturer bull Date vaccine was administered bull Lot number bull Date VIS was given bull Name and title of person who administered the
vaccine
A Number of records reviewed
B Number of records that contain ALL required documentation elements
If fewer than 10 records are reviewed select the reason why Provider does not have 10 patient records with immunizations in last 12 months
[X] Follow-up isrequired if one ormore records do not meet requirements
Goal of this question Assess whether the site is documenting all required information in each patientrsquos medical record for every vaccine dose administered in accordance with the National Childhood Vaccine Injury Act
Resources bull Section 6 of the MnVFC Policies and Procedures Manual bull National Vaccine Injury Compensation Program (wwwhrsagovvaccinecompensation)
Question 33
3 Documentation Record Retention
Question 33 Is the provider able to demonstrate (preferred) or clearly describe how they maintain historical VFCeligibility documentation for three years
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers are required to maintain all records related to the VFC program for a minimum of three years (or longer if requiredby state law) and upon request make these records available for review VFC records include but are not limited to VFC screening and eligibility documentation billing records medical records that verify receipt of vaccine vaccine ordering records and vaccinepurchase and accountability records
Goal of this question Make sure the site understands they are required to keep all MnVFC screening documentation for at least three years either electronically or on paper This information should be available to you at the time of the visit and future visits
Resource bull Section 7 of the MnVFC Policies and Procedures Manual
Page 26 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 34
3 Documentation Borrowing Documentation
Question 34 Discuss borrowing practices with the provider to answer the questions below
Note to Reviewer bull To be considered ldquofully documentedrdquo documentation for each borrowed dose must include thefollowing information
Vaccine type borrowed Date the dose was administered Stock used (VFC or private) Reason appropriate vaccine stock was not used Patient name and date of birth Date dose was returned to appropriate stock
A Did the provider state that they had borrowed any vaccines (whetherdocumented or not) since the last VFC Compliance Site Visit
Yes No (If no skip to question 36)
B Are there any doses for which there is no documentation (ie provider hasindicated that doses were borrowed but cannot verify how many or why)
All doses are documented Some doses are not documented [X] No doses are documented [X] (if nodoses documented skip toquestion 36)
C Were all borrowed doses fully documented (See Note to Reviewer above) Yes No [X]
D Were all borrowed VFC doses either replaced or an order submitted to replacethe doses Yes No [X]
Review CDC Requirement
VFC providers are expected to maintain an adequate inventory of vaccine for VFC and non-VFC-eligible patients It is theresponsibility of the VFC provider to appropriately schedule and place vaccine orders VFC providers must also rotate stock to ensure timely use of short-dated vaccines Borrowing of vaccine between private and public inventories must be a rare unplanned occurrence and cannot serve as a replacement system for a VFC providerrsquos privately purchased vaccine inventory All instances ofborrowing must be properly documented reported and replaced
Goal of this question Assess vaccine accountability by verifying that children are receiving vaccine from the appropriate stock
Borrowing is when a fully insured child receives a dose of MnVFC vaccine or a MnVFC-eligible child receives a dose of private vaccine This should be a rare unplanned occurrence The site must document any borrowing of vaccine between stocks ideally on the VFC Borrowing Report Form If they are not currently using the form review it with them and encourage them to post it close to their vaccines It does not need to be sent to MDH but should be kept for 3 years and filed with their MnVFC documents to be reviewed whenever they have a regular or unscheduled (unannounced) site visit
Helpful information bull Understand and report on staffrsquos verbal (ie anecdotal) accounts of borrowing obtained during the visit Often sites do not know that what they do is considered borrowing or they think borrowing is acceptable and documentation isnrsquot needed so long as those vaccines are eventually replaced
bull Since sites using the replacement method only have one stock of vaccine they very rarely borrow bull This question asks for future follow-up in 6 months Make a note on your calendar and ask them to send you a copy of their borrowing reports for the previous 6 months with documentation of doses borrowed and replaced We will remind you if we donrsquot hear from you at the 6 month time frame Complete the Follow-up Form and attach the borrowing form
Resources bull Vaccine Borrowing Report on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfc formshtml)
bull Section 10 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 27
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 353 Documentation Borrowing Reasons
Question 35 Based on your discussion with the provider and a review of borrowing reports document the dosesborrowed for each reason and answer the questions below
Note to Reviewer bull Short-dated vaccines are doses that are likely to expire before they can be used bull Exchanging short-dated vaccines should only occur in practices that have a small number of private
patients
A Reasons for Borrowing a VFC Dose (Enter the number of _____ Private vaccine shipment delay (order placed on time but delay in shippingreceipt)
vaccine doses borrowed for each
reason in the spaces
_____ Private vaccine not useable on arrival (vials broken temperature monitor out of range) _____ Ran out of private vaccine between orders (provider orders not placed on time) [X]
provided) _____ Short-dated private dose was exchanged with VFC stock _____ Accidental use of VFC dose for a private patient (human error) _____ Replacement of private dose with VFC when insurance plan did not cover vaccine _____ OtherDocumented dose did not include reason for borrowing [X]
(Explanation Required) Reasons for Borrowing a Private Dose _____ VFC vaccine shipment delay (order placed on time but delay in shippingreceipt) _____ VFC vaccine not useable on arrival (vials broken temperature monitor out of range) _____ Ran out of VFC stock between orders (provider orders not placed on time) [X] _____ Short-dated VFC vaccine dose was exchanged with private dose _____ Accidental use of a private dose for a VFC-eligible patient (human error) _____ OtherDocumented dose did not include reason for borrowing [X]
(Explanation Required)
B Enter date range for instances of borrowing reviewed in the borrowing report Note If ldquoDate of earliest instancerdquo is not available use the date of the last VFC Compliance Visit If ldquoDate of last instancerdquo is not available use the date of thecurrent VFC Compliance Visit
Date of earliest instance
Date of last instance
C Does borrowing appear to be a routine practice Note To determine whether borrowing is a routine practice assess frequency of and repeating reasons for borrowing Examples Frequent accidental use of incorrect stock exchanging short-dated vaccines or issues with ordering and shipment
Yes [X] No
Goal of this question Determine the reasons why the site is borrowing vaccine
If sites are using the Vaccine Borrowing Report review the reasons for borrowing to help document borrowed VFC andor private doses If they have not been documenting borrowing on this report (or any other form) estimate their borrowing practices If you do not know the date range for their borrowing use the last site visit date to the current visit date The use of ldquootherrdquo as the reported reason for borrowing should be rare if ever and would require explanation and follow up
Helpful information bull Look to see if they routinely maintain insufficient amounts or types of vaccine to support their public and private patients that leads to borrowing
bull Pay attention to borrowing cases documented as ldquoaccidentalrdquo Repetitive accidental borrowing may indicate an issue with ordering processes or insufficient staff training
bull Borrowing is not a place to document wasted or lost doses bull The time period of the borrowing may give you clues about the root cause Were the borrowed doses concentrated in a short period or spread out across several months or a year Are all vaccine types being borrowed or just one
bull If borrowing seems to be an issue discuss vaccine management ordering procedures
Resources bull Vaccine Borrowing Report on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfc formshtml)
bull Section 10 in the MnVFC Policies and Procedures Manual
Page 28 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 36
3 Documentation Vaccine Management Plan
Question 36 Physically review the providerrsquos Vaccine Management Plan to answer the question below
A Does the provider have a Vaccine Management Plan Yes No [X] (If no skip to question 37)
B Does the plan list the current Immunization Manager Vaccine Coordinator andback-up
Yes No [X]
C Does the plan address proper vaccine storage and handling practices Yes No [X]
D Does the plan specify vaccine receiving procedures Yes No [X]
E Does the plan contain procedures for what to do with vaccine in the event of an emergency
Yes No [X]
F Does the plan contain procedures for vaccine ordering Yes No [X]
G Does the plan address inventory control (example stock rotation) Yes No [X]
H Does the plan address how to handle vaccine wastage Yes No [X]
I Does the plan address staff training and documentation on vaccine managementstorage amp handling
Yes No [X]
J Does the plan contain a review date that falls within the last 12 months Yes No [X]
K Has the plan been signed by the individual responsible for its content Yes No [X]
Review CDC Requirement
VFC providers must develop maintain and implement a Vaccine Management Plan for routine and emergency vaccinemanagement The plan must contain the current Vaccine Coordinator and back-up proper storage and handling practicesshipping and receiving procedures emergency procedures procedures for vaccine ordering inventory control (eg stock rotation)how to handle vaccine wastage and staff trainingdocumentation on vaccine management storage and handling The plan must bereviewedupdated annually or more frequently if changes occur A ldquoreview daterdquo and signature are required on all plans in order tovalidate that they are current
Goal of this question Evaluate the sitersquos plan for vaccine management It is especially important that they have a plan for emergency management of their vaccine in the case of equipment failure or power outage Encourage all sites to read and sign the MnVFC Policies and Procedures Manual and complete the emergency plan or be able to show you a plan of their own
If the provider is not able to physically show you the plan at the time of the visit or if the recorded review date is not within the last 12 months you must mark that this requirement is unmet The Vaccine Management Plan is important in times of emergency and it should be easy to access by any staff member at any time Encourage them to post the plan and put a copy with the packing supplies
Helpful information bull Encourage the site to fill in the ldquoImmunization Managerrdquo and ldquoVaccine Coordinatorrdquo fields in the
MnVFC Policies and Procedures Manual for their own referencebull The emergency plan in the manual can be reviewed from last year and included in this yearrsquos manual (with an updated signature and date) if there have not been any changes
bull If information in the plan is outdated site staff will not be well equipped to safely manage vaccines in the event of a power-outage or other emergency situation
bull If their institutional policy is only reviewed and updated every 3-4 years (as many are) the staff may need to sign the MnVFC Polices and Procedure Manual to meet this requirement
Resource Routine Vaccine Management Plan and Emergency Vaccine Management Plan in the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 29
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 37
3 Documentation VIS amp VAERS
Question 37 Review the providerrsquos Vaccine Information Statements (VISs) and discuss providerrsquos VAERS process toanswer the questions below
A Does the provider have readily available up-to-date VISs for all ACIP-recommendedvaccines relevant to the populations it serves
Yes No [X]
B Does the provider make a VIS available for patientsparents before eachvaccination
Yes No [X]
C Does the provider know how and when to report clinically significant adverseevents using VAERS
Yes No [X]
Review CDC Requirement
VFC providers are required to distribute the current Vaccine Information Statements (VIS) each time a vaccine is administered and maintain records in accordance with the National Childhood Vaccine Injury Act (NCVIA) which includes reporting clinicallysignificant adverse events to the Vaccine Adverse Event Reporting System (VAERS) For a list of current VISs visit CDCrsquos Vaccine Information Statements (httpwwwcdcgovvaccineshcpvis) website
Gal of this question Ensure the site has the most current VISs and is giving them to each patientparent before administering the vaccine in compliance with the federal law Parents must be educated about the vaccine their child will receive and be aware of possible contraindications and side-effects in order to make well-informed decisions about their childrsquos health
Helpful information bull Ask to see the sitersquos VISs to determine if they have an active protocol for giving VISs to parents Review to make sure they are current Ask if they know where and how to report vaccine adverse events
Resources bull Section 3 in the MnVFC Policies and Procedures Manual bull CDC Vaccine Information Statements (wwwcdcgovvaccineshcpvisindexhtml) Site may sign up for email updates for the current list of VIS publication dates for the most up-to-date version
bull IAC Itrsquos Federal Law You must give your patients current Vaccine Information Statements (wwwimmunizeorgcatgdp2027pdf)
bull VAERS (httpsvaershhsgovindex)
Question 38
3 Documentation Anaphylaxis protocol
Question 38 Does the site have an anaphylaxis protocol which is clearly posted near the emergency kit
Answers (Choose one)
Yes No [X]
Review CDC Requirement
An anaphylaxis protocol must be clearly posted in the area where vaccines are administered
Goal of this question Make sure site is prepared for a severe allergic or anaphylactic reaction to a vaccine
Resources bull Section 11 in the MnVFC Policies and Procedures Manual bull IAC protocols Child and Teens (wwwimmunizeorgcatgdp3082apdf) and Adults (wwwimmunize orgcatgdp3082pdf)
Page 30 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
i
i i i - li i i i i i l
Section 4 Storage amp Handling Per Unit The goal of this section is to assess vaccine storage
2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet practices in each unit at the site MnVFC PIN ___________________
The 2017 MnVFC Storage amp Handling Per Unit Answer Sheet is a worksheet to document the answers to the questions in this section for each unit (combination or stand-alone) Fill in the answers to the questions in Section 4 on the answer sheet not in the questionnaire
The answer sheet has an abbreviated form of each question If you need further information on that question refer back to the full questionnaire Also if you find an area where the site is not meeting the requirements you will need to go back to that question on the 2017 MnVFC Site Visit Questionnaire to complete ldquoActions if Non- compliantrdquo section including the root cause analysis and follow-up sections If there is a problem in more than one unit make a note on the questionnaire which unit you are referring to in the Notes section
Important You must fully assess any unit that may be used to store VFC vaccines even if there are no VFC vaccines there on the day of the visit If there are no vaccines and the site is not documenting twice a day temperatures discuss the need to ensure the unit is maintaining stable temperatures by monitoring for one week before placing vaccines in the unit
Quest on number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
for the freezer and e co umn
Temperature Monitoring Dev refr gerator f the un
ce Quest ons Quest ons 4 3 4 7 must be answered separate y t s a combo Be sure to document responses n the appropr at
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
44D Data downloaded and reviewed routinely (eg weekly)
Yes No [O]
Yes No [O]
45A Certificate of Calibration Testing Yes No [X]
Yes No [X]
45B Date of calibration
45C Date certificate expires [X] Follow-up is required if expired [X] Follow-up is required if expired
45D Certificate contains all necessary items
Yes No [X]
Yes No [X]
46 Probe properly placed Yes No [X]
Yes No [X]
47A Two temperature readings per day
Yes No [X]
Yes No [X]
47B Time date and name (or initials) for each reading
Yes No [X]
Yes No [X]
47C Current temperature and minmax temperatures (if
Current ________deg Minimum ________deg Maximum _deg
Current ________deg Minimum ________deg Maximum _deg
Sections 5 and 6 contain questions about storage and handling site wide and inventory It is helpful to keep those questions in mind as you assess the individual storage units Think about dorm-style units expired vaccine vaccine supply room for vaccine stocking all the recommended vaccines and separation of stock if appropriate
NOTE The sections that follow require reviewers to validate responses by looking at vaccine storage units temperaturemonitoring equipment and the vaccine inventory inside a unit bull For section 4 use a separate Storage amp Handling Per Unit Answer Sheet for each unit to document the findings (combination
units using both sections can be documented on the same answer sheet) bull When an unmet requirement is identified return to this questionnaire to complete the ldquoActions if Non-compliantrdquo section for
that question bull After you complete one answer sheet for each unit return to the questionnaire to complete sections 5 and 6 using information
you gathered while assessing the units The questions in sections 5 and 6 (Storage amp Handling Site-Wide and Inventory) are notunit-specific but do require that the response be based on a thorough assessment of all the providersrsquo units
4 Storage amp Handling Per Unit
Description On the Storage amp Handling Per Unit Answer Sheet place a name that will allow you or someone else from your program to easily identify this unit in the event of follow-up We recommend using Brand + Location(example Samsung - Room 123) Save each Storage amp Handling Per Unit Answer Sheet with the Brand + Location in the file name
(example SamsungRoom123doc)
IPI Advisor Manual | February 2017 Page 31
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 41
4 Storage amp Handling Per Unit Storage Unit Build amp Use
Question 41 Below select the build and use of the vaccine storage unit you are assessing
Note to Reviewer Dorm-style units Do not add dorm-style units here Dorm-style units will be addressed in section 5 Units storing only private stock You must review these storage units even if they contain only private stockat the time of the visit because that vaccine could be administered to VFC patients
A What type of unit is this A Stand-alone B Combination
B Select use if stand-alone A Freezer B Refrigerator
Select use if combination A Use both sections to store vaccine B Use freezer section only to store vaccine C Use refrigerator section only to store vaccine
Goal of this question Identify the unit you are evaluating The description asks you to create a unique name for this unit so that you will be able to identify the same unit in future site visits Put this description on the top of the answer sheet (ie make and location)
Helpful information bull A stand-alone unit is either a refrigerator or a freezer It does not have both sections in the unit bull If there is a combination unit note if the site uses both the refrigerator and freezer or only one section of the unit to store vaccines CDC does not recommend the use of either section or the freezer section only of combination household units
bull If your site utilizes the separate stock method of vaccine management you must review storage units even if they contain only private stock at the time of the visit because there is a chance that those vaccines could be administered (borrowed) to VFC-eligible patients
Page 32 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 424 Storage amp Handling Per Unit CDC Recommended Storage Units
Question 42 Below document the grade of the vaccine storage unit you are assessing
Note to Reviewer Pharmaceutical Also called ldquopurpose-builtrdquo these units are designed by the manufacturer specifically tostore vaccines or other biological materials Commercial Although usually intended to store food and beverages commercial units are often larger and more powerful than the household units found in most homes Though these units are intended to meet thehigher demands of larger facilities these units are not specifically built for the storage of biologicalmaterials Household (non-commercialdomestic) These units are usually smaller than commercial units and areintended for use in small offices and in homes ndash typically for food storage However just like commercialunits they are not designed specifically for the storage of biological materials Such units are usually available in common home supply stores
Answers (Choose one)
Select grade A Pharmaceutical B CommercialHousehold
[O] CDC does not recommend the use of both sections or the freezer section only of combination commercialhousehold units
Review CDC Recommendation
CDC recommends the following vaccine storage unit types (in order of preference) pharmaceutical grade stand-alone orcombination units (preferred) householdcommercial stand-alone units householdcommercial combination units using therefrigerator section only
Goal of this question Assess the grade and type of each storage unit bull Pharmaceutical grade units may be stand-alone or combination units that are often metal may have glass in the door for viewing inside often have an external digital temperature display and are manufactured by medical companies
bull Commercial or household units often look like your kitchen appliance have vegetablemeat drawers in the unit and are manufactured by household appliance companies
bull Occasionally you might find a medical grade unit which is usually a commercialhousehold unit with a lock and 3-prong plug These are still considered household units because of their ability to maintain proper temperatures and air flow Studies show that household stand-alone units are better able to maintain consistent temperatures than their combination counterparts Combination household units used to store vaccine in both sections of the unit is no longer recommended and may be prohibited in the future Combination household storage units that are having difficulty maintaining a cold enough freezer temperature and a warm enough refrigerator temperature should be replaced or a separate stand-alone freezer should be purchased
For frozen vaccines the most cost effective solution is for the site to purchase a small stand-alone freezer The site may need time to budget for a stand-alone storage unit
Resources bull Replacing Combination Household Units Tip Sheet on IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml)
IPI Advisor Manual | February 2017 Page 33
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 434 Storage amp Handling Per Unit Temperature Monitoring Device in the Unit
Question 43 Determine whether there is a temperature monitoring device in this section of the storage unit andanswer the questions
A Is there a temperature monitoring device in this section of thestorage unit
Yes No [X] (If no skip to question 47)
B Who is responsible for supplying the temperature monitoring device in this section of the storage unit Provider
Review CDC Requirement
Certificates of calibration testing provide confidence that the temperature monitoring device is measuring temperaturesaccurately All units storing VFC vaccines must have a calibrated temperature monitoring device with a current and valid certificateof calibration testing All certificates must contain modeldevice name or number serial number date of calibration testing (report or issue date) and Instrument Passed testingInstrument in Tolerance (Recommended uncertainty = +-05ordm C (+-1ordm F))
Goal of this question Assess whether there is a temperature monitoring device in the unit If the unit is not being monitored at all call MDH at 651-201-5522 for guidance
Helpful information bull This question does not ask whether the temperature monitoring device is working or the characteristics of the device These issues will be addressed later in the questionnaire
bull For part B the provider is always responsible for supplying the temperature monitoring device Even if their thermometer or data logger was originally from MDH it is their responsibility to ensure it is functional and calibrated
Resources bull Section 8 in the MnVFC Policies and Procedures Manual
Page 34 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 444 Storage amp Handling Per Unit CDC Recommended Temperature Monitoring Device
Question 44 Assess the temperature monitoring device in this section of the storage unit to answer the questionsbelow
A Is the temperature monitoring device a continuous monitoring and recordingdevice (eg data logger)
Yes No [O] (Skip D)
B Does the temperature monitoring device have a probe in buffered material Yes No [O]
C Does the temperature monitoring device have a digital display that can beeasily read from the outside of this unit
Yes No [O]
D Is data downloaded and reviewed routinely Yes No [O]
Review CDC Recommendation
As of Jan 1 2018 all VFC providers must use continuous temperature monitoring devices (eg data loggers) to monitor vaccinesthat will be administered to VFC-eligible children Routine review and accessibility of temperature data is critical for determining whether vaccine has been properly stored and for assessing usability of vaccine that was involved in a temperature excursion Tomeet VFC Program requirements the device must also be equipped with bull A temperature probe bull An active temperature display that can be easily read from the outside of the unit bull The capacity for continuous monitoring and recording capabilities where the data can be routinely downloaded
The following are additional recommended features for these devices bull Alarm for out-of-range temperatures bull Current minimum and maximum temperatures display bull Low battery indicator bull Accuracy of +- 1degF (05degC) bull Memory storage of at least 4000 readings bull User programmable logging interval (or reading rate) recommended at a maximum time interval of every 30 minutes bull Use of a probe that best reflects the temperature of the vaccine (such as a buffered probe)
Goal of this question Assess the temperature monitoring device in the storage unit Note that these are all recommendations not requirements at this time
This is a great teaching opportunity for sites who do not currently have a continuous temperature monitoring device Beginning Jan 1 2018 all units that store MnVFC vaccine will be required to have a continuous temperature monitoring device (ie a data logger or a continuous temperature monitoring system) Unlike a minmax thermometer a continuous temperature monitoring device provides detailed information on all temperatures recorded at pre-set intervals For excursions it can provide information on when a temperature went out-of-range for how long and what the temperatures were This is essential information that vaccine manufacturers need to know to assess the viability of the vaccine following an excursion
Helpful information bull Sites are required to monitor and record temperatures twice daily however temperature excursions can easily occur in the 12 hours or longer between readings Continuous temperature monitoring can help manufacturers determine vaccine viability
bull Continue to encourage sites to document and evaluate minimum and maximum temperatures the storage unit reached since the last reading and respond appropriately to out-of-range temperatures
IPI Advisor Manual | February 2017 Page 35
The 2017 MnVFC Site Visit Paperwork Chapter 4
bull It is recommended that sites download and review data weekly Discuss with sites that reviewing temperature monitoring device data also includes responding appropriately if they identify out-of-range temps
bull There is sometimes confusion about the difference between a data logger and a continuous temperature monitoring system Here are some differences
Data Loggers Continuous Monitoring Systems Have an external display similar to thermometers May or may not have an external display Have a detachable probe Probe is usually attached to transmitter Need to be plugged into the computer or cradle to download information on a regular schedule
Wirelessly sends data to computer system
Create a file of data that needs to be saved on the computer
Data is stored within the system not a separate file
Doesnrsquot allow documentation of twice a day temperature checks in the file
May allow documentation of twice a day temperature checks within the system
More about the 2018 requirement for a continuous temperature monitoring device
Required Features bull The continuous temperature monitoring device must have Continuous monitoring and recording capabilities to track and record temperatures over time The capacity to routinely download temperature data to a computer (recommended at least weekly) or wirelessly transmit data Detachable probe in a bottle filled with a thermal buffer (eg bio-safe glycol) if the data logger needs to be detached in order to download data Active temperature display
Recommended Features bull MnVFC recommends continuous temperature monitoring devices with Alarm for out-of-range temperatures Accuracy within +-1degF (+- 05degC) Low battery indicator Display of current minimum and maximum temperatures Memory storage of at least 4000 readings User programmable logging intervals (eg the user can set how often the device records the temperature)
Note that these are all currently recommendations not requirements yet
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Page 36 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 45
Goal of this question Ensure the temperature monitoring device is properly calibrated The certificate of calibration testing means that the device has been tested and it is accurately measuring temperatures within established testing limits The certificate of calibration ensures that the device meets all the required components
Helpful information bull The provider is always responsible for having a current certificate of calibration (or copy) on-site
bull To be considered ldquovalidrdquo a certificate of calibration must contain these required elements Modeldevice name or number Serial number
4 Storage amp Handling Per Unit Certificate of Calibration Testing
Review CDC Requirement
Certificates of calibration testing provide confidence that the temperature monitoring device is measuring temperaturesaccurately All units storing VFC vaccines must have a calibrated temperature monitoring device with a current and valid certificateof calibration testing All certificates must contain modeldevice name or number serial number date of calibration testing (report or issue date) and Instrument Passed testingInstrument in Tolerance (Recommended uncertainty = +-05ordm C (+-1ordm F))
Question 45
Note to Reviewer
A
B
C
D
E
Review the certificate of calibration testing for the temperature monitoring device in this section of the storage unit and answer the questions below
bull How to determine certificate of calibration testing expiration date 1) Identify the certificate issuecalibration date 2) Apply the Immunization Program-required frequency for calibration testing Example If the
issuecalibration date is 12312013 and Immunization Program policy requires testing every twoyears the expiration date is 12312015
bull Certificates must include all of the below bull ModelDevice Name or Number bull Serial Number bull Date of Calibration Testing (Report or Issue Date) bull Instrument Passed testing (Instrument in Tolerance)
Is there a certificate of calibration testing for the temperature monitoring Yes device in this section of the storage unit No [X]
What is the date of calibration for the temperature monitoring device in this section of the storage unit
What is the certificatersquos date of expiration based on ImmunizationProgram policy (See note to reviewer to determine expiration date) [X] Follow-up is required if
certificate is expired
Does the certificate contain all the necessary items listed in the Note to Yes Reviewer No [X]
Who is responsible for supplying the current and valid certificate of Provider calibration for this temperature monitoring device
Date of calibration testing (report or issue date) Note If there is no expiration date the certificate expires 2 years from the date of calibration Whether the instrument passed or failed testing (or instrument in tolerancenot in tolerance)
bull Recommended element Documented uncertainty of +- 1degF [05degC]
If these elements are present the certificate is considered valid If the certificate contains information about the recommended element or the entity that issued the certificate that is helpful but not required
To determine if a certificate of calibration testing was issued by an appropriate entity check to see if the certificate indicates one or more of these items (this is the wording used to help sites evaluate if their calibration is accurate but is not required on the certificate itself to be considered valid)
bull Conforms to ISO 17025 bull Performed by an ILACMRA Signatory body accredited laboratory You can review this list of the ILAC MRA and Signatories (httpilacorgilac-mra-and-signatories)
bull Traceable to the standards maintained by NIST bull Meets specifications and testing requirements for the American Society for Testing and Materials (ASTM) Standard E2877 tolerance Class F (le 05 degC) or better
bull Includes reference to another acceptable accuracy validation method such as comparison to other traceable reference standards or tests at thermometric fixed points
Note CDC recommends that certifications be issued for the entire monitoring unit (detachable probe data logger etc) and not individual certificates for each component
IPI Advisor Manual | February 2017 Page 37
The 2017 MnVFC Site Visit Paperwork Chapter 4
For 45 E the provider is always responsible for supplying the current and valid certificate of calibration for a temperature monitoring device
bull Tip If the temperature monitoring device has a sticker on the back with the calibration date the site can usually call the company who calibrated the device and get a copy of the certificate if they donrsquot have one
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 46 4 Storage amp Handling Per Unit Probe Placement
Question 46 Is the probe properly placed in this section of the storage unit
Note to Reviewer ldquoProperlyrdquo means that the probe in a commercial or household unit is placed in a central area of the unitdirectly with the vaccines Probes should not be placed in the doors near or against the walls close to vents or on the floor of the unit The only allowable exemption related to this requirement is for providerswho have pharmaceutical storage units (built for vaccine storage) that have either (1) a built-intemperature monitoring device OR (2) a dedicated port for the probe that dictates the placement of theprobe
Answers (Choose one)
Yes No [X]
Review CDC Requirement
The probe must be placed in a central area of the section of the storage unit directly with the vaccines in order to properly measurevaccine temperature The probe should not be placed in the door near or against the walls close to vents or on the floor of theunit For pharmaceutical units with a built-in temperature monitoring device or a dedicated port for a probe that is not in thecenter of the section of the storage unit consult your Immunization Program for guidance on placement
Goal of this question Make sure the temperature monitoring device is in the best location to accurately measure the temperature of the vaccines stored in the unit
Helpful information bull The probe of the temperature monitoring device should be placed directly with the vaccines in the middle of the unit The ONLY allowable exception is for pharmaceutical storage units that have either a built-in thermometer or a dedicated port for the probe that indicates placement of the probe
bull Temperatures can vary within the unit especially household units bull Call MDH at 651-201-5522 if you have questions
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Guide (wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml)
Page 38 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 474 Storage amp Handling Per Unit Temperature Documentation
Question 47 Review the temperature documentation over the past three months for this section of the storage unit todetermine whether the provider has a process in place for properly documenting temperatures twice aday Answer the questions below
A Are there two temperature readings recorded for this section of the storage unit per day
Yes No [X]
B Is there a time date and name (or initials) recorded for each reading Yes No [X]
C What is the current temperature and minmax temperatures (if available) inthis section of the storage unit Use the reviewerrsquos thermometer if the providerrsquos temperature monitoringdevice does not have a current valid certificate of calibration testing or the probe is not properly placed in this section of the storage unit
Current Temperature Minimum Temperature Maximum Temperature Fahrenheit Celsius
D Based on your review of the providerrsquos recent temperature documentationincluding the current temperature is this section of the storage unitmaintaining appropriate temperatures
Yes No [X] Not enough information [X]
Review CDC Requirement
Vaccines must be stored under appropriate temperatures as described in the package inserts at all times Acceptable temperature ranges vary by vaccine type and the range is 36deg F and 46deg F (2deg C and 8deg C) and for frozen vaccines the range is -58deg F and +5deg F (shy50deg C and -15deg C) Exposure to temperatures outside of those included in the package inserts could affect vaccine viability andultimately could leave children unprotected against vaccine-preventable diseases In order to maintain awareness of storage unittemperatures and ensure that vaccines are being stored at appropriate temperatures at all times VFC providers are required to monitor and document temperatures for all vaccine storage units at least twice a day Temperature documentation must contain (1) at least two temperature readings per day (2) the time and date of each reading and (3) the name (or initials) of the personwho assessed and recorded the readings CDC also recommends that VFC providers record the minimum and maximumtemperatures of each unit once each workday (preferably in the morning)
Goal of this question Ensure the temperature is being monitored twice daily is within the required range and documented correctly Use your thermometer to check the temperature if the sitersquos temperature monitoring devicersquos probe is not properly placed or there is not a current certificate of calibration Place your thermometer in the unit at the beginning of the visit to allow sufficient time to reach an accurate temperature The purpose of using your thermometer is to ensure the vaccine is being stored at the proper temperature not to ldquovalidaterdquo their reading
Question 47 D is an assessment question based on information you have learned during your visit You might answer ldquonot enough informationrdquo if the unit is new and they donrsquot have at least three months of data or if the unit is only used as overflow and they are inconsistent with temperature monitoring Mark ldquoNordquo if you have reason to believe the storage unit is not maintaining temperatures properly
Helpful information bull All sites must document temperatures twice a day every day the site is open even if they have a data logger or continuous monitoring system
bull Sites can document the information electronically with some continuous monitoring systems as long as it can show what the current temp is the date time and initials of the person checking ndash this needs to be someone at the site ndash not checking remotely or centrally for a large site or system The site must be able to produce these records during their site visit Reviewing these files can be a challenge due to large volumes and lots of paper
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Temperature Logs on Managing Vaccine (wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml)
IPI Advisor Manual | February 2017 Page 39
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 484 Storage amp Handling Per Unit Temperature Excursions
Question 48 In the event that a temperature excursion(s) occurred in this unit within the last three months requestand review documentation of actions taken to determine whether the provider has a process for properlyaddressing excursions Answer the questions below
A Were vaccines in this unit exposed to out-of-range temperatures in the lastthree months (including today)
Yes No (If no skip to question 49)
B Did the provider quarantine and label vaccines as ldquoDo not userdquo Yes No [X]
C Did the provider place vaccine in a unit where it can be stored under properconditions if applicable
Yes No [X]
D Did the provider contact the Immunization Program to report theexcursion
Yes No [X]
E Was the manufacturer contacted for documentation supporting theusability of the vaccine
Yes No [X]
Review CDC Requirement
The provider must document all excursions and actions taken including the following (1) Quarantine and label vaccines as ldquoDO NOTUSErdquo (2) Place vaccines in a unit where they can be stored under proper conditions (3) Contact the Immunization Program to report an excursion and (4) Contact the vaccine manufacturer to obtain documentation supporting the usability of the vaccine
Goal of this question Address any out-of-range temperatures (temperature excursions) identified in reviewing the last three months of temperature logs or during the site visit If there were any out-of-range temperatures did the site respond appropriately to the situation This is a great opportunity to discuss what to do in the event of an excursion The Clinicians Storage and Handling Mishap Checklist is in the IPI Site Visit information folder and is a good review of the process
Helpful information bull Sites need to know that an excursion does not automatically mean that exposed vaccines are non-viable or unusable Exposed vaccines must be quarantined (marked ldquoDo Not Userdquo) and stored under proper conditions until they have received information from vaccine manufacturers regarding the viability of the vaccine
bull Sites must inform MDH when an excursion occurs
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Clinicians Storage and Handling Mishap Checklist (wwwhealthstatemnusdivsidepcimmunize ipivaxchklstpdf)
Page 40 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 49
Goal of this question Ensure proper placement of vaccines in the storage unit
Note These are all recommendations (best practices) not requirements
Helpful information bull Store vaccine in the middle of the compartment two to three inches away from the coils walls floor and cold air vent The temperature near the floor and walls of the unit differs from that in the middle of the compartment and the cold air vent can freeze refrigerated vaccines
4 Storage amp Handling Per Unit Vaccine Placement
Question 49 Look inside the unit to answer the questions below
A Are vaccines placed in the middle of the unit with space between vaccinesand the sideback of the unit to allow cold air to circulate
Yes No [O]
B Are vaccines stored in their original packages Yes No [O]
C Are there water bottles (for refrigerators) or frozen water bottles (forfreezers) in the unit
Yes No [O]
D Are vaccines store in the doors vegetable bins under or near cooling ventsor on the floor of the unit
Yes [O] No
E Is food being stored in the unit Yes [O] No
Review CDC Recommendation
Vaccines should be stored in their original manufacturer (or CDC centralized distributor) packaging They should be placed in the middle of the unit with space between the vaccines and the sideback of the unit to allow cold air to circulate Vaccines SHOULD NOT be stored in the doors vegetable bins or floor of the unit or under or near cooling vents and there should not be any food inthe unit Water bottles (for refrigerators) or frozen water bottles (for freezers) should be placed throughout each storage unit inorder to (1) stabilize or extend temperatures during a power outage and (2) to serve as physical blocks preventing the placementof vaccines in areas of the unit that are at higher risk for temperature excursions (such as in doors vegetable bins floor ornearunder cooling vents)
bull Vaccines should be kept in their original packaging to Protect them from light Help prevent medication errors by making labels easier to read Provide a moisture barrier that serves as insulation in case of an out-of-range temperature power outage door left open or mechanical failure Simplify managing vaccine inventory
bull Store water bottles in the doors on the floor and near the cold air vent in the refrigerator and frozen water bottles in the freezer to help maintain a stable temperature if there is a power failure and when the door is opened frequently Too many water bottles in the door can prevent the door from closing tightly Mark water bottles ldquoDo Not Drinkrdquo
bull Do not store vaccine in the door or drawers of the refrigerator or freezer Vegetable bins and crisper drawers should be removed from refrigerators or used to store other medical supplies or water bottles
bull If vaccine is stored in a household combination refrigeratorfreezer The top shelf should not be used for storing vaccine because the cold air vent blowing from the freezer will freeze vaccine located there If you must use the top shelf of this type of unit place water bottles underneath the cold air vent to prevent vaccine from being stored there It is recommended that only the refrigerator be used for vaccine storage and a separate stand-alone freezer be used to store frozen vaccine
bull Must not store food or beverages in the refrigerator or freezer because frequent opening of doors can lead to temperature variations that may affect vaccine viability There is also a risk of contaminating vaccines
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Guide (wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml) bull Vaccine Storage Tip Sheet on IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml)
IPI Advisor Manual | February 2017 Page 41
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 4104 Storage amp Handling Per Unit Disconnection from Power Source
Question 410 Ask the provider to demonstrate what measures are taken to ensure that vaccine storage units are notaccidentally physically disconnected from the power supply Which of the following describes the measure(s) taken on this unit
Note to Reviewer bull Large hospitals and healthcare systems may not have the ability to demonstrate labels on plugs or circuitbreakers In such cases verify that the practice has a comprehensive policy and standard operatingprocedures in place to prevent the vaccine storage unit from being physically disconnected from thepower supply
bull While back-up generators may ensure power to the overall facility this question ONLY addresses thevaccine storage unit being accidentally disconnected from the power source either through the plug orthe circuit breaker
Answers A ldquoDo not disconnectrdquo labels on the plug (Choose all that B ldquoWarningrdquo label on the circuit breaker box
apply) C Hard-wired (ie built-in) and has a ldquoDo not disconnectrdquo label on thecircuit breaker box D Hospital or large health care system with a comprehensive written policyand standard operating procedures detailing measures taken to preventvaccine storage units from being accidentally disconnected from the powersupply E No acceptable measures for preventing accidental disconnection frompower supply [X]
[X] The response is non-compliant if only A only B or E is selected
Review CDC Requirement
VFC providers must take steps to protect the power source for all vaccine storage equipment by means of having clear warninglabels on both the plug and the circuit breaker associated with all vaccine storage units Large hospitals and healthcare systems canmeet this requirement by demonstrating that they have comprehensive policies and standard operating procedures to preventvaccine storage units from being physically disconnected from the power supply
Goal of this question Decrease the chance that a vaccine storage unit will be accidently unplugged or power will be turned off while vaccine is in the unit This question addresses only what measures the site has taken to ensure the storage unit is not physically disconnected from its power source
If the site uses labels on the plugs and circuit breakers perform a visual inspection to assess whether the way the stickers are positioned make it clear and obvious to anyone that these units are not to be disconnected
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Do Not Unplug and Warning stickers are included in the folder or available to order on the For
Professionals Order Form (wwwhealthstatemnusdivsidepcimmunizeordermathtml)
Note Once you have completed the 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet for each unit return to the questionnaire to complete sections 5 and 6
Page 42 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
- -
Section 5 Storage amp Handling Site-Wide Question 51
5 Storage amp Handling Site Wide Discussion of Cost amp Quantity of Vaccine
Question 51 Have a discussion with the provider about the cost and quantity of VFC vaccines they are responsible for annually Address the points listed in the note to reviewer below
Note to Reviewer bull Vaccine Shipped (Required) Share the cost of VFC vaccines shipped to the provider in the last calendaryear to make sure the provider understands the contribution made by the VFC Program to their practiceFor new providers who do not have ldquocalendar yearrdquo data share either the actual cost of their currentinventory or use the cost of 10 VFC doses of each of the ACIP-recommended vaccines (approximately $7000) to help estimate their annual cost
bull Storage amp Handling (Required) Make sure the provider understands the cost of vaccines for which they are responsible when they make decisions about purchasing recommended vaccine storage and temperature monitoring equipment
Answer I have discussed with the provider the cost and quantity of vaccines ordered in the previous calendar year
Goal of this question Inform sites of the quantity and value of vaccines that they receive as part of the MnVFC program Providers often donrsquot realize the value of the vaccine in their unit This information is included on your clinic list and on the one page site-specific information
Helpful information bull This discussion must occur and the box on the questionnaire must be checked bull If there isnrsquot actual vaccine value information available tell the site that one vaccine order that includes a box of each of the ACIP recommended vaccines costs approximately $7000
bull MDH may not have specific information for individual sites if they receive vaccine from a central warehouse or pharmacy For those sites MDH will give you numbers for the whole system so you can discuss system wide data as appropriate If individual site information is also included it is usually just varicella-containing vaccines that must be shipped directly to the site
Question 52
5 Storage amp Handling Site Wide Dorm Style Units
Question 52 Determine whether the provider has any dorm-style units on site and answer the questions below
Note to Reviewer A dormitory-style refrigerator is a unit that has both refrigerator and freezer compartments behind a singleexterior door Dorm-style units also have an evaporator plate (cooling coil) which is usually located insidean icemaker compartment (freezer) within the refrigerator
A Does the provider have any dorm-style units that are used at any time tostore vaccines
Yes [X] No (Skip to question 53)
B Does the provider have sufficient space in existing compliant vaccinestorage units to store all vaccines without use of the dorm-style unit at any time
Yes No [X]
Review CDC Requirement
Dorm- and bar-style units are prohibited for vaccine storage Vaccines stored in dorm-style units are considered non-viable and must be returned to the centralized distributor CDC recommends the following vaccine storage unit types (in order of preference)pharmaceutical grade stand-alone or combination units (preferred) householdcommercial stand-alone unitshouseholdcommercial combination units using the refrigerator section only
Goal of this question Ensure no vaccine is stored in dorm-style units even for short periods of time Encourage them to label any units ldquoNo Vaccine Storage Allowedrdquo Vaccine stored in these units is considered non-viable If a site is using a dorm-style unit call the MnVFC program (651-201-5522)
Resource Section 8 in the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 43
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 535 Storage amp Handling Site Wide Storage Unit Space Availability
Question 53 Does the provider have sufficient room across storage units to store current stock as well as anyadditional stock acquired during peak season without overcrowding
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have sufficient storage space to accommodate vaccine stock at the busiest time of year without overcrowding
Goal of this question Ensure that sites have sufficient space in their units to maintain vaccines at the busiest time of year Overcrowding of vaccine limits air circulation and affects the unitrsquos ability to maintain stable temperatures
Helpful information bull Look for signs of overcrowding such as vaccines that are pushed up against the wall bins that are overflowing or storage units that are full during non-peak seasons
Discuss immediate actions if the unit is overcrowded Move some of their vaccines order less vaccine more frequently (once per month preferably) andor purchase another storage unit for overflow
Resource bull Section 8 MnVFC Policy and Procedure Manual
Page 44 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 545 Storage amp Handling Site Wide Expired Vaccines
Question 54 Look in each unit Are there expired vaccines in any of the vaccine storage units at this site
Answers (Choose one)
Yes [X] No
Review CDC Requirement
Vaccines should be rotated weekly and when a new shipment comes in so that longer-dated vaccines are stored behind shorter-dated vaccines If vaccines expire they can no longer be stored in the same storage unit with viable vaccines They must be placedin a container or bag clearly labeled ldquoDo not userdquo and separated from viable vaccines to prevent inadvertent use Expired vaccinemust be returned to the centralized distributor within six months of expiration
Goal of this question Ensure there is no expired vaccine in any storage unit
Helpful information bull Sites can prevent their stock from expiring by rotating vaccines every week andor when a new shipment arrives Longer-dated vaccines are stored towards the back of the unit and shorter-dated vaccines are up front
bull Pay attention to vaccines that expire within the next three months Consider transferring vaccine that will expire soon to another MnVFC-enrolled site that will use the vaccine preferably a site close by It is the transferring sitersquos responsibility to arrange the transfer of the vaccine Be sure to complete the MDH Vaccine Transfer Record form and send it to MDH If they are having difficulty finding a location to accept vaccine contact MDH
bull This is a great opportunity to educate sites about the MDH Nonviable Vaccine Form and the process for returning vaccine The VFC program does get some credit for taxes and fees on vaccine that is returned to the distribution center
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MDH Nonviable Vaccine Form and MDH Vaccine Transfer Record on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfcformshtml)
IPI Advisor Manual | February 2017 Page 45
The 2017 MnVFC Site Visit Paperwork Chapter 4
- -
-
Question 555 Storage amp Handling Site Wide Back up Thermometer
Question 55 Does the provider have a readily available back-up thermometer with a current and valid certificate ofcalibration testing
Note to Reviewer ldquoReadily availablerdquo means that the thermometer is available to perform twice-a-day monitoring for a unit asrequired CDC recommends that the back-up thermometer be maintained on site
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have a readily available back-up thermometer with a current and valid certificate of calibration testing Toprevent the certificates of calibration testing of the primary and back-up thermometers from expiring at the same time the date of calibration testing (or issue date) of the back-up thermometer should be different from the date of calibration testing (or issue date) of the primary thermometer As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meetsVFC program requirements
Goal of this question Ensure sites have one calibrated back-up thermometer onsite that is readily available in the event that the temperature monitoring device in unit fails transportation of vaccine is needed or there are other unexpected circumstances
Helpful information bull As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meets VFC Program requirements
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 56 5 Storage amp Handling Site Wide Preparation of Vaccine
Question 56 When does this provider prepare vaccine for administration to the patient
Note to Reviewer For mass vaccination clinics if one type of vaccine is offered providers may pre-draw up to 10 doses Ifusing pre-filled syringes pre-drawing also means activating the syringe by removing the needle guard orattaching a needle
Answers (Choose all that
apply)
Prepare dose immediately before administration Pre-draw doses for upcoming patients (in a regular clinicpractice) [O] Pre-draw up to 10 doses (in a mass-vaccination clinic) Pre-draw more than 10 doses (in a mass-vaccination clinic) [O] Other [O]
Review CDC Recommendation
CDC recommends preparing vaccines immediately prior to administration in order to assure viability of vaccine and prevent vaccinewastage Vaccines that are not administered immediately are at risk of exposure to temperatures outside of the required rangewhich can affect vaccine viability and ultimately can leave children unprotected against vaccine-preventable diseases
Goal of this question Discuss proper timing and preparation of vaccine(s) for administration These are recommendations not requirements
Helpful information bull Educate staff on the importance of preparing vaccine immediately before administration Pre-drawing of vaccines may lead to concerns related to vaccine viability potency sterility and wastage
Page 46 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 6 Inventory Question 61
6 Inventory Inventory Comparison
Question 61 Visually inspect storage units to determine if existing supply of vaccines proportionately mirrorspopulations served Choose the most accurate statement below
Note to Reviewer bull CDC recommends that providers maintain a four-week supply of inventory bull For this question do not take into account vaccine types that the provider does not order Here simply
make sure that overall the vaccines in the providerrsquos storage units are available in sufficient amounts toserve their patient population
Answers (Choose one)
The current vaccine inventory proportionately reflects the populations identified Only public stock is insufficient [X] Only private stock is insufficient [X] Both public and private stock are insufficient [X] Site uses the replacement method but does not appear to have enough vaccine for their population [X] Other [X]
Review CDC Requirement
VFC providers must order and stock routine vaccines in accordance with their patient population in order to prevent missedvaccination opportunities Having sufficient amounts of all stocks prevents the inadvertent use of VFC vaccines for non-VFC-eligiblepatients and vice versa
Goal of this question Assess whether the site is ordering appropriate quantities of vaccine for the population they serve at their site
Helpful information bull If the site sees 30 percent private-pay patients and 70 percent VFC the stock in their storage units should reflect that proportion If you donrsquot know you can ask the site about their population
bull This is meant to be a general assessment so in a big site if they have only a small amount of vaccine that may indicate an issue with vaccine management
bull CDC recommends smaller more frequent orders (ie monthly) rather than large orders to minimize the amount of vaccine loss if an incident occurs during shipment or in the storage unit Sites should not order more frequently than once a month
bull Sites using the replacement method will only have one stock but it should appear to be large enough for their population
bull Only assess the vaccine types that the site currently stocks in their unit We know there are sites that do not offer all ACIP-recommended vaccines for various reasons That issue will be addressed in question 62
IPI Advisor Manual | February 2017 Page 47
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 626 Inventory ACIP Recommended Vaccines
Question 62 Review providerrsquos current inventory to answer the questions below
A Does the provider offer all routine ACIP-recommendedvaccines for their patient population
Yes (Skip to question C) No [X] Offers all except varicella because direct ship ofvaccine is unavailable from manufacturer
B Which routine vaccines are NOT being offered DTaP Hepatitis A Hepatitis B HIB HPV Influenza Meningococcal
MMR Pneumococcal Polio Rotavirus TdapTd Varicella
C According to Immunization Program Policy does theprovider make accessible all non-routine ACIP-recommended vaccines for those VFC patients whomeet the criteria for receiving them
Yes (Skip to question 63) No [X]
D Which non-routine vaccines are NOT being offered Pneumococcal polysaccharide vaccine (PPSV23) Meningococcal Group B (MenB) Other
Review CDC Requirement
VFC providers agree to comply with immunization schedules dosages and contraindications that are established by the Advisory Committee on Immunization Practices (ACIP) for the vaccines identified and agreed upon in the Provider Agreement UNLESS bull In the VFC providers medical judgment and in accordance with accepted medical practice the VFC provider deems such
compliance to be medically inappropriate for the child bull The particular requirements contradict state law including laws pertaining to religious and other exemptions The VFC program entitles children to the following vaccines DTaP Hepatitis A Hepatitis B HIB HPV Influenza MeningococcalMMR Pneumococcal Polio Rotavirus TdapTd and Varicella VFC providers are also required to ensure that VFC-eligible children have access to non-routine vaccines as needed
Goal of this question Assess if the site is offering all the ACIP-recommended vaccines for the population they serve and these vaccines are in stock on the day of the visit It is important that every MnVFC-eligible child that comes to a providerrsquos office for an immunization is vaccinated
Helpful information bull The Advisory Committee on Immunization Practices (ACIP) is a group of medical and public health experts that develops recommendations on how to use vaccines to control diseases in the United States
bull Specialty providers are not required to offer all routine vaccines but should provide the vaccines appropriate for their population
bull If the site does not offer all routine ACIP-recommended vaccines appropriate for their population check the ldquoNordquo box in Part A then check the appropriate box(es) in Part B for any vaccines not offered Please contact MDH as this situation offers us the opportunity to provide education to the site
bull For non-routine vaccines they must either be in stock or the site must have an alternative protocol in the routine management plan that ensures these children have access when applicable
Resources bull IAC Diseases and Vaccines (wwwimmunizeorgvaccines) bull CDC Advisory Committee on Immunization Practices (ACIP) (wwwcdcgovvaccinesacipindexhtml)
Page 48 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 636 Inventory Separation of Stock
Question 63 Observe how the provider differentiates stock in each storage unit to answer the questions below
A Is it clear which vaccines belong to public stock andwhich belong to private stock
Yes No [X] Not applicable replacement site
B Is it clear which vaccines belong to VFC stock andwhich belong to UUAV stock
Yes No [X] Not applicable replacement site Not applicable not UUAV-enrolled site
Review CDC Requirement
In order to ensure that VFC vaccines are only administered to VFC-eligible children VFC providers that serve both VFC and non-VFCshyeligible children must maintain their vaccine inventories in such a way that they can clearly differentiate public stock from privatestock as well as VFC from other public stock
Goal of this question Assess whether the site can distinguish between MnVFC vaccine and private vaccine If they participate in the Uninsured and Underinsured Adult Vaccine (UUAV) program they should also be able to distinguish between MnVFC stock and UUAV stock Some sites use labels bins boxes etc to differentiate their stock If it is not clear how the site differentiates their stock discuss vaccine management with the staff For follow-up call MDH to discuss doing a follow-up site visit
Sites using the replacement method will not have separate stocksmdashthis is an approved alternative method for keeping track of vaccine
Resource bull Section 10 of the MnVFC Policy and Procedure Manual
IPI Advisor Manual | February 2017 Page 49
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
MnVFC Site Visit Storage and Handling Per Unit Answer Sheet 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet MnVFC PIN ___________________
Question number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
Temperature Monitoring Device Questions Questions 43 47 must be answered separately for the freezer and refrigerator if the unit is a combo Be sure to document responses in the appropriate column
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
All the questions on the Site Visit Storage amp Handling Per Unit Answer Sheet have been discussed previously in section 4 of this manual Use this sheet to record information about all the units at the site visit You will need one sheet for each unit If it is a combination unit (either pharmaceutical or household) you can record both sections on one sheet If they have stand-alone units use one sheet for each unit Do not enter the answers to the questions in section 4 of the questionnaire
If you need more information about any of the questions refer back to the main questionnairemdashthe complete question additional guidance including notes to the reviewer and the CDC requirements are there Also if the site is not meeting the requirement you will go back to the questionnaire to complete the ldquoActions if Non-compliantrdquo section including the root cause analysis and follow-up sections
When you have completed the assessment of all the storage units remember to go back to the questionnaire to complete sections 5 and 6
Page 50 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
ndash
ndash
MnVFC Provider Follow-up PlanThe goal of the Provider Follow-up Plan is to communicate with the site all of the VFC requirements any unmet requirements found during your site visit and the timeline for completing the required action The left hand column is a box to check for ldquoUnmetrdquo requirements
Helpful information bull The form can be used to review what the site is doing well and what they need to work on
bull For requirements that have specific documentation that needs to be sent to you use the notes section
2017 MnVFC Provider Follow-up Plan Site _______________________________________________ MnVFC PIN ____________ Date of Visit ___________
Thank you for participating in this MnVFC compliance site visit Please review this visit summary including follow-up actions and timelines for completion Unmet MnVFC requirements and recommendations have a checked box next to them The goal of this plan is to support you with successfully implementing the program and improving access to vaccines for VFC-eligible children
Unmet Question VFC Requirements Section 1 Changes to Key Staff
Q12 Change in the Medical Director Immunization Manager Vaccine Coordinator or back-upKey Staff must be communicated to the immunization program by emailing healthmnvfcstatemnus Changes Notes
Q12 Key staff must complete the annual training on VFC program requirements and print theAnnual Training certificate of completion Documentation Required Action
Staff that have not completed the MnVFC online training must complete it and send acopy of the certificate to the reviewer Training can be found on the MnVFC website (wwwhealthstatemnusvfc) Due date 1 month
Notes
Unmet Question VFC Requirements Section 2 Eligibility
Q21 Provider staff must possess a working knowledge of all VFC eligibility criteria and use thoseVFC Eligibility criteria to screen children prior to administering VFC vaccines
Categories Notes
bull This form provides documentation needed for follow-up actions when you send your thank you email
The second to last page of the Provider Follow-up Plan has a summary of the MnVFC program recommendations These are to remind the site about best practices they may want to improve upon even though they are not yet requirements of the program For example you could discuss the recommendation about storage units if they currently have a combination household unit and are using both sections
The last section is for your signature and the person you met with In most sites it will be the immunization manager or vaccine coordinator who signs the form unless the medical director attended the site visit You keep the original copy and the site will need to keep a copy for themselves
To be completed by the site visit reviewer
I acknowledge that a VFC site visit was performed on __________________ (visit date) The follow-up plan which includes a list of all current VFC program requirements and recommendations assessed during the visit and any required follow-up actions was provided at the end of the visit
Site visit reviewer
Phone
Reviewer Signature Date
To be completed by the provider
I acknowledge that our practice took part in the VFC site visit noted above I understand the findings of the visit and any required actions that must be taken by our office in order to meet VFC program requirements
Medical Director (or designee) Name Title
Medical Director (or designee) Signature Date
IPI Advisor Manual | February 2017 Page 51
The 2017 MnVFC Site Visit Paperwork Chapter 4
After the Site Visit Send a thank you email highlighting the unmet requirements documents you need from the site to resolve the issue(s) and the date you need them Make sure to include the link to the Site Visit Survey (httpssurveyvovicicomseashxs=56206EE334CE0B14)
Please refer to Chapter 3 for more information about future follow-up required after the visit including forms and documentation
Resource bull Sample Thank You letter on IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml)
Chapter 5
IPI Advisor Resource List MnVFC Program 651-201-5522
MnVFC wwwhealthstatemnusvfc
bull Separate Stock and Replacement Method Policies and Procedures Manuals bull Online trainings bull MnVFC Announcements sign up to receive them via email bull Ordering MDH vaccine bull MnVFC forms Screening forms Reporting forms Others MDH Nonviable Vaccine Form MDH Vaccine Transfer Record and Vaccine Borrowing Report
bull MnVFC promotional materials bull Immunization Billing Guidance for MnVFC and Immunization Billing Guidance for MnVFC Replacement Sites Immunization Practices Improvement Program (IPI) wwwhealthstatemnusdivsidepcimmunizeipi
bull IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml) bull IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml) IPI Resource Folder Contents (wwwhealthstatemnusdivsidepcimmunizeipiipifolderpdf)
Minnesota Immunization Information Connection (MIIC) wwwhealthstatemnusmiic
bull MIIC regions and regional coordinators
Clinical Practice MDH Immunization Program wwwhealthstatemnusimmunize
Got Your Shots News wwwhealthstatemnusdivsidepcnewslettersgys
MDH Immunization Information for Health Care Providers wwwhealthstatemnusdivsidepcimmunizehcp
bull Got Your Shots A Providers Guide to Immunization in Minnesota bull Vaccine protocols bull Forms for tracking patient immunizations bull Immunization schedules for Health Care Providers Immunization Action Coalition (IAC) wwwimmunizeorg
bull Ask the Experts bull VISs (Vaccine Information Statements and translations) bull Administration screening questions bull Medical management of vaccine reactions bull Order form for Californiarsquos Immunization Technique DVD Best Practices with Infants Children and Adults
Page 52 IPI Advisor Manual| February 2017
IPI Advisor Resource List Chapter 5
CDC ldquoPink Bookrdquo wwwcdcgovvaccinespubspinkbookindexhtml
CDC Advisory Committee on Immunization Practices (ACIP) wwwcdcgovvaccinesacip
CDC Vaccines and Immunizations wwwcdcgovvaccines
VAERS reporting httpvaershhsgovindex
Storage and Handling Got Your Shots Providers Guide ndash Managing Vaccine wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml
MnVFC Guide to Temperature Monitoring Devices wwwhealthstatemnusvfc
MDH Clinicianrsquos Vaccine Mishap Checklist wwwhealthstatemnusdivsidepcimmunizeipivaxchklstpdf
MDH Vaccine Storage Guide wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml
CDC Vaccine Storage and Handling Toolkit wwwcdcgovvaccinesrecsstoragetoolkit
You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Vaccine manufacturer phone numbers wwwcdcgovvaccinespubspinkbookdownloadsappendicesFcontact-info-manufactpdf
IAC Checklist for Safe Vaccine Handling and Storage wwwimmunizeorgcatgdp3035pdf
IAC Donrsquot Be Guilty of These Errors in Vaccine Storage and Handling wwwimmunizeorgcatgdp3036pdf
Additional Resources Print materials from MDH ndash order forms wwwhealthstatemnusdivsidepcimmunizeordermathtml
Vaccine Education Center ndash Childrenrsquos Hospital of Philadelphia wwwchopeduservicevaccine-education-centerhomehtml
California Department of Public Health ndash Interactive training on vaccine administration and storage and handling handout on transporting vaccine and how to package wwwezizorg
IPI Advisor Manual | February 2017 Page 53
IPI Advisor Resource List Chapter 5
CDC vaccine price list wwwcdcgovvaccinesprogramsvfcawardeesvaccine-managementprice-listindexhtml
Vaccine Information Statements (VIS) wwwcdcgovvaccineshcpvisindexhtml
CEU Opportunities CDC Immunization Education and Training wwwcdcgovvaccinesedindexhtml
Immunization You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Page 54 IPI Advisor Manual| February 2017
- Introduction
-
- Welcome to the Immunization Practice Improvement (IPI) Program
- Contact Information
-
- Chapter 1
- Requirements to Participate in the MnVFC Program
- Vaccines for Children Program
- Chapter 2
- Reimbursement for MnVFC Visits
- Types of Visits
- Your MnVFC Clinical CoordinatorPlanner
- New IPI Advisor Training Requirements
- Your Role as an IPI Advisor
- Reasons MDH Would Do All or Part of a Visit
- Chapter 3
- Future follow-up
- Conducting the Visit
- Preparing for the Visit
- Information for the Visit
- Site Visit Checklist
- Scheduling the Visit
- Chapter 4
- After the Site Visit
- MnVFC Provider Follow-up Plan
- MnVFC Site Visit Storage and Handling Per Unit Answer Sheet
- Section 6 Inventory
- Section 5 Storage amp Handling Site-Wide
- Section 4 Storage amp Handling Per Unit
- Section 3 Documentation
- Section 2 Eligibility
- Section 1 Provider Details
- The Site Visit Reviewer Legend
- MnVFC Site Visit Questionnaire
- Required Paperwork for Site Visits
- Chapter 5
-
Site Visits Chapter 3
Conducting the Visit Education is a large part of the MnVFC site visit Often approaching this visit as an exchange of information with the site is more successful than a ldquoregulatoryrdquo visit Putting the staff at ease answering their questions and making a plan to address issues that arise during the visit is more helpful than a ldquopassfailrdquo attitude Education will usually consist of providing the rationale for the requirement referring to the requirement in the MnVFC Policies and Procedures Manual and providing resources to help address the situation Some questions will require additional follow-up to assure the site has corrected the issue(s) and is meeting the MnVFC requirement(s) This will be addressed further in the follow-up section
Completing the Paperwork
There are three documents that you must complete for the MnVFC site visit bull 2017 MnVFC Site Visit Questionnaire bull 2017 MnVFC Site Visit Storage amp Handling per Unit Answer Sheet (one for each storage unit) bull 2017 MnVFC Provider Follow-up Plan (two copies or you may ask them to make you a copy of the completed form for their records)
Answer the questions on the MnVFC Site Visit Questionnaire based on how things are when you arrive at the site If they correct the issue during the visit you will still mark it as an unmet requirement and document how it was addressed during the visit
The ldquoAnswerrdquo field will contain all the possible answer choices for this question For most questions answer choices will be followed by the markings below
bull Answer choices with no marking mean the site meets the CDC requirement bull Answer choices marked with an [X] indicate that this specific answer choice is non-compliant with a CDC requirement
bull Answer choices marked with an [O] indicate that this specific answer choice is not aligned with a CDC recommendation
If you marked the box with the [X] which is non-compliant with the CDC requirement conduct a root cause analysis to determine the reason for non-compliance Root cause analysis is an important component to a successful site visit It is used to identify the cause of the problem and help to resolve the issue There are several possible root causes that can be identified Choose only one root cause
bull Human cause Personal beliefsopinions Does not understand rationale of requirement Lack of concern for compliance
bull Organizational cause Competing job assignmentsworkload Lack of (insufficient) staff to perform required duties Budget limitations (for required equipment) Lack of (insufficient) training of staff Lack of (insufficient) processesprotocols
IPI Advisor Manual | February 2017 Page 13
Site Visits Chapter 3
Once identified the root cause should be documented in the questionnaire including a brief explanation of why you chose that cause This allows for follow-up with the site and a way to help find improvements to meet the unmet requirement Complete any immediate on-site action These often require providing education and resources for the site Mark the box for each action taken If you provide additional resources or information you can use the notes section to indicate the additional items
ldquoFuture follow-uprdquo are actions the site needs to take to meet the requirements of the program Wersquoll go over more specific information about the site visit questionnaire in Chapter 4
Performing the Site Visit
As you become familiar with the MnVFC program and develop a relationship with your sites you will develop a visit pattern that works for you Here is one possible sequence for conducting MnVFC site visits
bull When you arrive at the site if you have a business card it is helpful to provide it to the front desk staff person
bull When you meet with the immunization manager andor vaccine coordinator introduce yourself and explain the expectations for the visit
bull Ask to see the temperature monitoring device(s) It must have a current certificate of calibration and the probe must be properly placed in the unit If it does not meet the requirements place your thermometer in the unit at the beginning of the visit so that it has sufficient time to reach an accurate temperature by the time you complete your assessment of the storage units
bull 2017 MnVFC Site Visit Questionnaire Ask all of the questions You may have to modify the order of the questions based on what is best for the site When you get to the storage and handling section (section 4) use the answer sheet(s) to document the answers to the questions for each storage unit that stores vaccine (MnVFC or private) Do not write answers in the questionnaire unless there is an unmet requirement Be sure to ask if there is vaccine stored anywhere else at any time at this location This includes a co-located pharmacy If so these additional units will need to be assessed as well If the site has a combination refrigeratorfreezer household unit and is using both sections discuss with them the recommendation (and probable future requirement) to have a separate freezer Refer to MDH if they have further questions or need more information Be prepared to address any storage and handling mishaps that you may find A copy of the
Clinicianrsquos Vaccine Mishap Checklist is with your visit materials and the Emergency Response Worksheet is in the MnVFC Policy and Procedure Manual If you are unsure how to handle the problem call the MnVFC program at 651-201-5522 during or after the visit
Page 14 IPI Advisor Manual | February 2017
Site Visits Chapter 3
Ending the Visit bull Fill out the two copies of the 2017 MnVFC Provider Follow-up Plan (or ask them to make a copy once it is completed for their records) Indicate if they have not met the requirement by checking the box in the ldquoUnmetrdquo column If they are not meeting requirements check the required actions Review the plan with them reinforcing the positive things they are doing as well as reviewing the required follow-up action(s) Give the site a copy of the Provider Follow-up Plan Keep the signed copy of the Provider Follow-up Plan to submit with your paperwork Do not leave a copy of the Site Visit Questionnaire at the site
bull Let them know you will be sending a thank you email that will summarize the site visit Included in the email will be a survey link you would appreciate them completing regarding the visit
After the Visit bull Send the site a thank you email There is a template thank you letter on the IPI Advisor Site Visit Materials (wwwhealthstate mnusdivsidepcimmunizeipisvmaterialshtml) page Be sure you include the issues that you identified and the timeline for their completion as well as the good things you found at the visit In the template letter be sure to include the survey link The survey is very brief ndash a few questions and space to write comments
bull Either transfer your MnVFC Site Visit Questionnaire and MnVFC Site Visit Storage amp Handling per Unit Answer Sheet information to the fillable version or submit the handwritten form to MDH
Documentation of the Visit
Paperwork must be submitted to MDH within 10 days of the visit in order to meet the federal VFC programrsquos reporting requirements Do not wait to complete your follow-up before submitting the site visit paperwork
Send the following documents to MDH bull 2017 MnVFC Site Visit Questionnaire (includes the cover sheet) bull 2017 MnVFC Site Visit Storage amp Handling per Unit Answer Sheet (one for each unit) bull 2017 MnVFC Provider Follow-up Plan (original signed plan)
Submit site visit materials to bull Email healthIPIinquiriesstatemnus (preferred) bull Mail IPI Program Specialist
Immunization Practices Improvement Program Minnesota Department of HealthPO Box 64975St Paul MN 55164-0975
IPI Advisor Manual | February 2017 Page 15
Site Visits Chapter 3
Future follow-up Follow-up is an important component of the site visit It helps us ensure that the unmet requirements have been corrected The questionnaire has different time periods for follow-up depending on the question Do not wait to complete your follow-up before submitting the site visit paperwork
When you complete the Follow-Up Form make sure to keep a copy for yourself MDH also keeps track of follow-up required and will remind you if follow-up has not been completed by the deadline Most follow-up can be done with a phone call or email In-person follow-up is rarely required and should be discussed with MDH before scheduling a follow-up visit
All requirements that need follow-up are identified with a [X] on the site visit paperwork and are listed on the MnVFC Provider Follow-up Plan
bull Follow-up with the site to see how they have resolved the unmet requirements bull Document your follow-up on the Follow-Up Form available on the IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml) page If follow-up was done via letter or email a copy can be attached to the Follow-Up Form
bull Send your Follow-Up Form to MDH (healthIPIinquiriesstatemnus) with supporting documents and emails
bull If a site is not responding to your requests regarding follow-up contact your MnVFC clinical coordinatorplanner They can help with additional follow-up as needed
Page 16 IPI Advisor Manual | February 2017
Chapter 4 The 2017 MnVFC Site Visit Paperwork This chapter will go through the required MnVFC site visit paperwork with notes about information or resources to help the site address questions or issues that may arise during the visit
The MnVFC site visit paperwork is available on the IPI Advisor Site Visit Materials (wwwhealthstate mnusdivsidepcimmunizeipisvmaterialshtml) page
Please download the paperwork shortly before your visit as there may be updates and changes and this will be the most up-to-date version of the questionnaire We will send out a Workspace message with major changes
Required Paperwork for Site Visits bull 2017 MnVFC Site Visit Questionnaire bull 2017 MnVFC Storage amp Handling Per Unit Answer Sheet ndash one for each unit assessed during site
visit bull 2017 MnVFC Provider Follow-up Plan ndash with provider signature
Make sure to include the sitersquos PIN on all your paperwork Please complete and submit your site visit paperwork as soon as possible after your visit It may be helpful to schedule some time into your calendar to complete your paperwork in the days following your visit Once you have completed the post-visit follow-up send in the Follow-Up Form with documentation of the follow-up actions Please do not wait until you have completed your follow-up before sending in your initial paperwork
MnVFC Site Visit Questionnaire The questionnaire includes these six sections 1 Provider details 2 Eligibility 3 Documentation 4 Storage amp handling per unit 5 Storage amp handling site-wide 6 Inventory
IPI Advisor Manual | February 2017 Page 17
Page 18 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
The Site Visit Reviewer Legend The legend explains the formatting of the 2017 questionnaire This includes information that will be helpful in completing the site visit
Site Visit Reviewer Guide Legend
Section Number Content Area
Question number This area will always contain the text of the question
Note to reviewer The note to reviewer contains information that is necessary for properly asking and assessing responses tothe question above This may include definitions of terms requirement details and other helpful tips
Answers This field will contain all the possible answer choices for this question For most questions answer choiceswill be followed by the markings below
Answer choices marked with an [X] indicate that this specific answer choice is non-compliant with a CDC requirement Answer choices marked with an [O] indicate that this specific answer choice is not aligned with a CDC
recommendation
Review CDC RequirementRecommendation
This field will be populated with the CDC requirementrecommendation associated with the given question
Actions if Non-Compliant
Root Cause Analysis As part of the site visit reviewers are required to assess and understand the reasons why a provider office isnon-compliant with VFC program requirements ndash this is a root cause analysis Reviewers must choose theone root cause that they believe most contributes to the non-compliance Upon establishing the root causethe reviewer must provide a clear explanation of hisher findings
Immediate Action These are actions that CDC requires reviewers to take on site during the visit
Future Follow-up These are future follow-up actions (with designated due dates) that are required of the reviewer andorprovider to remedy non-compliance Reviewers must complete all follow-up in accordance with CDCestablished deadlines
Notes Information you want the VFC program to be aware of or that explains your answer in detail
bull Note to reviewer These are notes to help you understand what the question is asking for and to clarify things you might want to know when asking or rephrasing the question
bull Answers This section helps you to know when the answer does not meet the CDC requirement [X] or recommendation [O] Whenever an answer with a [X] is checked the ldquoActions if Non-compliant section must be completed The recommendations are usually good teaching points about best practices andor future requirements of the VFC program
bull Review the CDC RequirementRecommendation This section provides a specific outline of the requirement or recommendation to give you information to use in talking with the site staff
bull Actions if Non-Compliant This section describes what to do if the site is not meeting a requirement Root cause analysis This section asks you to probe beyond the surface to find what is driving the non-compliance It is intended to help uncover reasons for recurring non-compliance issues identify additional training needs and inform reviewer follow-up actions Select only one root cause and explain the particular circumstances in the space ldquoExplanation of root causerdquo line provided If there appear to be multiple issues choose the one that most contributes to the non-compliance and describe all factors in the explanation Immediate actions A list of actions to take during the site visit to address the issue Future follow-up A list of actions to take after the site visit by the set deadline
bull Notes This section can be used for notes to yourself or to MDH
IPI Advisor Manual | February 2017 Page 19
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 1 Provider Details Questionnaire Coversheet
The first page of the questionnaire collects the demographic information for the site You can use this page to help prepare for the visit Most of the demographic information about the site should be on the site-specific document you received with your clinic list You will validate that this information is current at the time of the site visit It also helps to know if this is a separate stock site or a replacement site before the visit so you can bring a copy of the appropriate MnVFC Policies and Procedure Manual
2017 MnVFC Site Visit Questionnaire Date of visit _____________ Date forms sent to MDH ______________
Site Information
Site name MnVFC PIN
Address Separate Stock Replacement
City ZIP County
Medical Director Email
Immunization Manager Phone
Vaccine Coordinator Phone
Vaccine Coordinator back-up Email
Point of contact Phone
Personnel at site visit
On this page bull The date of the visit and the date when you send these forms to MDH This information helps us track the timeliness of our review and data entry process
bull The vaccine management method used by the site (replacement or separate stock) bull The name and email of the medical director (ideally this is the person who signed the MnVFC
Program Provider Agreement)bull Contact information for the immunization manager vaccine coordinator vaccine coordinator back-up and point-of-contact for this visit The immunization manager vaccine coordinator vaccine coordinator back-up roles are
described in the MnVFC Policies and Procedure Manual The vaccine coordinator back-up may be the immunization manager or another staff person depending on the size of the site and available personnel The Point of Contact is the person you set up the appointment with signs the Provider Follow-
up Plan and receives the follow-up email This may be one of the people listed above
The Post Visit Steps section is a reminder to you about what needs to done after the visit The Education on Immunization Best Practices for Sites section reminds you to provide the resource folder to the site
Page 20 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 12
1 Provider Details Changes to Key Staff
Question 12 Ask the provider about changes to key staff to answer the questions below
A (Choose all that
apply)
At the time of the visit is the Medical Director the same individual that signed the ProviderAgreement and are the Immunization Manager and Vaccine Coordinator the same asthose last reported to the program
Yes No the Medical Director has changed No the Immunization Manager has changed No the Vaccine Coordinator has changed
B (Choose one)
Were all changes communicated to theImmunization Program according to yourprogramrsquos policy
Yes or no staff changes No [X]
C (Choose one)
Based on review of the trainingdocumentation have the current Immunization Manager Vaccine Coordinator and back-up completed all required training
Yes No [X]
Review CDC Requirement
All changes in key staff must be communicated to the Immunization Program in the manner and timeframe defined by theImmunization Program Key staff include the Medical Director or equivalent who signed the Provider Agreement the Immunization Manager Vaccine Coordinator and the back-up VFC providers are required to ensure that all key staff are fully trained on VFC program requirements at all times All training must be documented
Goal of this question Determine if there are new staff in key positions at the site and to make sure staff are properly educated about the MnVFC program A This information can help you determine the level of knowledge and experience the staff have with the MnVFC program Follow-up throughout the visit can be tailored for various levels of staff experience Likewise you may identify additional training needs for new staff
B When sites notify us of changes in key personnel we update their information in MIIC and on the clinic lists We also send the new staff information for completing the online training and direct them to read the appropriate MnVFC Policies and Procedures Manual If the answer to this part is no update the demographic area of the questionnaire and inform the staff that in the future they must notify the MnVFC program (via email or phone) if the immunization manager or vaccine coordinator changes Resource Section 12 of the MnVFC Policies and Procedures Manual
C Annual training must be verified by looking at the certificates for the online training If the answer to this part is no refer the staff to complete the appropriate MnVFC online training found on the MnVFC website (wwwhealthstatemnusvfc) for their program (separate stockreplacement) for the current year and send you a copy of the certificate within 30 days
Resource bull Sections 12 and 14 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 21
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 2 Eligibility Question 21
Goal of this Question Assess whether staff correctly understand which patients are eligible for the MnVFC program Screening ensures that eligible children receive the vaccines that they are entitled to receive under the MnVFC program and helps to prevent fraud or abuse of the program
Children 18 years and younger in these
categories can receive MnVFC vaccine at any enrolled site bull Uninsured bull Enrolled in a Minnesota Health Care Program (MHCP) Medical Assistance (MA) or MinnesotaCare bull American Indian or Alaskan Native
The following categories are considered underinsured and are only MnVFC-eligible at local public health (LPH) Federally Qualified Health Centers (FQHC) Rural Health Centers (RHC) Indian Health Services (IHS) and tribal health clinics
bull Has health insurance that does not cover one or more vaccines as can be the case with newly licensed vaccines that arenrsquot yet covered (MnVFC-eligible for non-covered vaccines only)
bull Has health insurance that caps vaccine coverage at a certain amount Once that amount is reached the child is MnVFC-eligible
Children with insurance that does not cover vaccines until a deductible has been met are considered to be fully insured and are not MnVFC-eligible
Helpful information bull Sites are not required to verify the patientrsquos response to the screening questions For example if a patient states they lost their insurance the site does not need to call the patientrsquos insurance company to confirm
If the site cannot correctly describe the eligibility categories provide educational materialsresources on MnVFC eligibility requirements
Resources bull Patient Eligibility Screening Record on MnVFC Forms (wwwhealthstatemnusdivsidepc immunizemnvfcformshtml)
bull Section 1 of the MnVFC Policies and Procedures Manual
2 Eligibility VFC Eligibility Categories
Question 21 Was the individual responsible for determining patient VFC eligibility able to explain all the factors(including age) that make a child eligible to receive VFC vaccines
A Patient is less than 19 years of age Yes No [X]
B Patient is Medicaid-eligible Yes No [X]
C Patient is uninsured Yes No [X]
D Patient is underinsured Yes No [X]
E Patient is American Indian Yes No [X]
F Patient is Alaska Native Yes No [X]
Review CDC Requirement
VFC providers must possess a working knowledge of all VFC eligibility criteria and use those criteria to screen children prior toadministering VFC vaccines In order to receive VFC vaccine a patient must be under the age of 19 and must be at least one of the following (1) Medicaid-eligible (2) Uninsured (ie child has no health insurance) (3) Underinsured (ie child has health insurancebut coverage does not cover any or certain vaccines ndash underinsured children may only receive VFC vaccines in FQHCRHC ordeputized VFC provider offices and only for vaccines not covered by insurance) and (4) American Indian or Alaska Native (AIAN)
Page 22 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 22
2 Eligibility Billing Practices
Question 22 Is the individualdepartment responsible for billing able to clearly explain how they bill for both the costof vaccine and the vaccine administration fee for each of the eligibility categories below
A Medicaid-eligible Cost of Vaccine Do not bill ndash provided by VFC Admin Fee Bill Medicaid
Yes No [X]
B Uninsured Cost of Vaccine Do not bill ndash provided by VFC Admin Fee If billing can bill patient
Yes No [X]
C Underinsured Cost of Vaccine Do not bill ndash provided by VFC through FQHCsRHCs or deputized providers only all other providers cannotprovide VFC vaccine to underinsured patients Admin Fee If billing can bill patient
Yes No [X]
D American IndianAlaska Native(AIAN)
Cost of Vaccine Do not bill - provided by VFC unless patient is fully insured and parent chooses to use insurance Admin Fee If patient is Medicaid-eligible bill Medicaid if billingand patient is uninsuredunderinsured can bill patient if parentchooses to use private insurance for cost of vaccine billpatientinsurance
Yes No [X]
E Do individuals responsible for billing have access to the results of eligibility screening toensure proper billing
Yes No [X]
Review CDC Requirement
VFC providers must adhere to proper billing practices for vaccine administration fees and clearly understand that VFC vaccine isprovided at no cost to both the VFC provider and eligible children At no time should billing occur for the cost of VFC vaccine Whenadministering VFC vaccine providers should never bill two different ldquopayersrdquo (ie patient Medicaid insurance) for the samevaccine administration fee amount For Medicaid-eligible children Medicaid should be billed for the vaccine administration fee Forall other VFC-eligible populations the patient may be billed within the stateterritory cap established by the Centers for Medicareand Medicaid (CMS) However patients cannot be turned away or reported to collections for inability to pay the administration fee
Goal of this question Determine if the staff correctly understand how to bill patients that are eligible for the MnVFC program Billing appropriately ensures that children can receive low cost immunizations and the site is in compliance with the VFC program
bull If there is any indication that sites could be billing insurance companies or parents for VFC vaccines this should be investigated further
bull Most sites in Minnesota will bill Medicaid with the SL modifier ndash which indicates this is a Medicaid claim
bull The main point is to ensure the site is not billing uninsured children for VFC vaccine and are not charging them more than $2122 per vaccine for the administration fee
bull Non-compliance is usually unintentional and may be resolved with some training In rare cases it could be a glimpse into a larger problem where a site is intentionally billing for financial gain
bull If you think the site is billing inappropriately it is the responsibility of the IPI advisor to report concerns to MDH staff for further assistance
Resources bull Immunization Billing Guidance for MnVFC (wwwhealthstatemnusdivsidepcimmunizemnvfc billingtipshtml) or Immunization Billing Guidance for MnVFC Replacement Method Sites (www healthstatemnusdivsidepcimmunizemnvfcreplacementbillingtipsrephtml)
bull Section 2 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 23
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 232 Eligibility Vaccine Administration Fee
Question 23 Document the actual vaccine administration fee charged to non-Medicaid VFC-eligible patients (confirmwith billing department)
Answers Fee $ [X] Follow-up is required if the provider charges more than the fee cap establishedby the Centers for Medicare and Medicaid (CMS) for your stateterritory ($2122)
Review CDC Requirement
The VFC providerrsquos vaccine administration fee for non-Medicaid VFC-eligible children must not exceed the stateterritory vaccineadministration fee cap established by the Centers for Medicare and Medicaid (CMS) For current fee caps refer to Medicaid Program Payments for Services Furnished by Certain Primary Care Physicians and Charges for Vaccine Administration Under theVaccines for Children Program Final Rule (httpwwwgpogovfdsyspkgFR-2012-11-06pdf2012-26507pdf)
Goal of this question Ensure that sites are not charging more than the federal allowable vaccine administration fee of $2122
bull The Centers for Medicaid and Medicare (CMS) establishes a maximum fee that sites can charge to non-Medicaid-eligible VFC patients in each stateterritory for vaccine administration Health Plans usually negotiate this fee with the site but Medicaid will not pay more
bull If a parent cannot pay the vaccine administration fee the patient cannot be turned away or reported to collections VFC-eligible children must be vaccinated regardless of their ability to pay
bull If the person with whom you are conducting the site visit does not know the exact fee charged to non-Medicaid VFC-eligible patients ask to speak to someone who can verify the exact amount
bull If they are charging more than $2122 for the administration fee ndash please contact MDH staff for help with addressing this situation
Resources bull Immunization Billing Guidance for MnVFC (wwwhealthstatemnusdivsidepcimmunizemnvfc billingtipshtml) or Immunization Billing Guidance for MnVFC Replacement Method Sites (www healthstatemnusdivsidepcimmunizemnvfcreplacementbillingtipsrephtml)
bull Section 2 of the MnVFC Policies and Procedures Manual
Page 24 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 3 Documentation Question 31
3 Documentation Eligibility Screening amp Documentation
Question 31 To answer the questions below the provider must clearly demonstrate the patient intake processReview a minimum of 10 records that contain an immunization visit within the last 6 ndash 12 months
Note to Reviewer Criteria for Record Selection 1) Record selection must be completely random and the provider must not know prior to the visit which
records will be reviewed 2) Patient must have been 0-19 years of age at the last visit (Note Records of 19-year-old patients may
allow you to see if VFC vaccines are being used beyond the allowable age) 3) Must review a mix of public and private-pay patients (if applicable)
A Does the provider have a process that ensures that patients are screened forVFC eligibility at each visit and that screening results are documented at each visit
Yes No [X] (If no skip question F)
B Does the providerrsquos process ensure that staff administering vaccine know which vaccine stock to select from prior to drawing the vaccine
Yes No [X]
C Number of records reviewed If fewer than 10 records are reviewed select the reason why Provider does not have 10 patient records with immunizations in last 12 months
D Do all records contain date of the immunization visit and patientrsquos date of birth Yes No [X]
E Do all records contain the patientrsquos specific eligibility status associated with thedate of the immunization
Yes No [X]
F Do any of the providerrsquos records contain any evidence that the patient received vaccine for which they were not eligible
Yes [X] No
Review CDC Requirement
VFC providers must screen for and document VFC eligibility at each immunization visit Documentation must include the date of the visit and the childrsquos specific eligibility category VFC providers must use screening results to ensure that only VFC-eligible children receive VFC vaccine and that administration fees are billed for as appropriate Eligibility status must be readily available to staff administering vaccine prior to selecting which vaccine stock to use
Goal of this question Ensure the site is screening for eligibility and documenting the eligibility category in the medical record
Review a minimum of 10 records from within the last 6-12 months where the patient received an immunization You must review a mix of public and private pay patients (if applicable)
Random selection is important If the staff have pre-selected records for review do not use and identify additional randomly selected records to review
Helpful information bull Discuss upgrading the electronic health record to make documentation of VFC eligibility screening a required field Documenting eligibility screening in the immunization field promotes better MIIC data
bull Q 31 B Sites using the replacement method of vaccine management only have one stock so you will answer ldquoYesrdquo to this question
Resources bull Patient Eligibility Screening Record on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfcformshtml)
bull Section 1 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 25
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 32
3 Documentation Vaccine Dose Documentation
Question 32 Review a minimum of 10 patient immunization records from the last six months (or 12 months ifnecessary) to assess compliance with documentation requirements set forth by Statute 42 US Code 300aa-25 (See note to reviewer below)
Note to Reviewer Criteria for Record Selection 1) Record selection must be completely random the Provider must not know prior to the visit which records
will be reviewed 2) Patient must have been 0-19 years of age at the last visit (Note Records of 19-year-old patients may allow
you to see if VFC vaccines are being used beyond the allowable age)
Records are Compliant if they Contain ALL the Below Elements
bull Address of clinic where vaccine was administered bull Publication date of VIS bull Name of vaccine administered bull Name of vaccine manufacturer bull Date vaccine was administered bull Lot number bull Date VIS was given bull Name and title of person who administered the
vaccine
A Number of records reviewed
B Number of records that contain ALL required documentation elements
If fewer than 10 records are reviewed select the reason why Provider does not have 10 patient records with immunizations in last 12 months
[X] Follow-up isrequired if one ormore records do not meet requirements
Goal of this question Assess whether the site is documenting all required information in each patientrsquos medical record for every vaccine dose administered in accordance with the National Childhood Vaccine Injury Act
Resources bull Section 6 of the MnVFC Policies and Procedures Manual bull National Vaccine Injury Compensation Program (wwwhrsagovvaccinecompensation)
Question 33
3 Documentation Record Retention
Question 33 Is the provider able to demonstrate (preferred) or clearly describe how they maintain historical VFCeligibility documentation for three years
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers are required to maintain all records related to the VFC program for a minimum of three years (or longer if requiredby state law) and upon request make these records available for review VFC records include but are not limited to VFC screening and eligibility documentation billing records medical records that verify receipt of vaccine vaccine ordering records and vaccinepurchase and accountability records
Goal of this question Make sure the site understands they are required to keep all MnVFC screening documentation for at least three years either electronically or on paper This information should be available to you at the time of the visit and future visits
Resource bull Section 7 of the MnVFC Policies and Procedures Manual
Page 26 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 34
3 Documentation Borrowing Documentation
Question 34 Discuss borrowing practices with the provider to answer the questions below
Note to Reviewer bull To be considered ldquofully documentedrdquo documentation for each borrowed dose must include thefollowing information
Vaccine type borrowed Date the dose was administered Stock used (VFC or private) Reason appropriate vaccine stock was not used Patient name and date of birth Date dose was returned to appropriate stock
A Did the provider state that they had borrowed any vaccines (whetherdocumented or not) since the last VFC Compliance Site Visit
Yes No (If no skip to question 36)
B Are there any doses for which there is no documentation (ie provider hasindicated that doses were borrowed but cannot verify how many or why)
All doses are documented Some doses are not documented [X] No doses are documented [X] (if nodoses documented skip toquestion 36)
C Were all borrowed doses fully documented (See Note to Reviewer above) Yes No [X]
D Were all borrowed VFC doses either replaced or an order submitted to replacethe doses Yes No [X]
Review CDC Requirement
VFC providers are expected to maintain an adequate inventory of vaccine for VFC and non-VFC-eligible patients It is theresponsibility of the VFC provider to appropriately schedule and place vaccine orders VFC providers must also rotate stock to ensure timely use of short-dated vaccines Borrowing of vaccine between private and public inventories must be a rare unplanned occurrence and cannot serve as a replacement system for a VFC providerrsquos privately purchased vaccine inventory All instances ofborrowing must be properly documented reported and replaced
Goal of this question Assess vaccine accountability by verifying that children are receiving vaccine from the appropriate stock
Borrowing is when a fully insured child receives a dose of MnVFC vaccine or a MnVFC-eligible child receives a dose of private vaccine This should be a rare unplanned occurrence The site must document any borrowing of vaccine between stocks ideally on the VFC Borrowing Report Form If they are not currently using the form review it with them and encourage them to post it close to their vaccines It does not need to be sent to MDH but should be kept for 3 years and filed with their MnVFC documents to be reviewed whenever they have a regular or unscheduled (unannounced) site visit
Helpful information bull Understand and report on staffrsquos verbal (ie anecdotal) accounts of borrowing obtained during the visit Often sites do not know that what they do is considered borrowing or they think borrowing is acceptable and documentation isnrsquot needed so long as those vaccines are eventually replaced
bull Since sites using the replacement method only have one stock of vaccine they very rarely borrow bull This question asks for future follow-up in 6 months Make a note on your calendar and ask them to send you a copy of their borrowing reports for the previous 6 months with documentation of doses borrowed and replaced We will remind you if we donrsquot hear from you at the 6 month time frame Complete the Follow-up Form and attach the borrowing form
Resources bull Vaccine Borrowing Report on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfc formshtml)
bull Section 10 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 27
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 353 Documentation Borrowing Reasons
Question 35 Based on your discussion with the provider and a review of borrowing reports document the dosesborrowed for each reason and answer the questions below
Note to Reviewer bull Short-dated vaccines are doses that are likely to expire before they can be used bull Exchanging short-dated vaccines should only occur in practices that have a small number of private
patients
A Reasons for Borrowing a VFC Dose (Enter the number of _____ Private vaccine shipment delay (order placed on time but delay in shippingreceipt)
vaccine doses borrowed for each
reason in the spaces
_____ Private vaccine not useable on arrival (vials broken temperature monitor out of range) _____ Ran out of private vaccine between orders (provider orders not placed on time) [X]
provided) _____ Short-dated private dose was exchanged with VFC stock _____ Accidental use of VFC dose for a private patient (human error) _____ Replacement of private dose with VFC when insurance plan did not cover vaccine _____ OtherDocumented dose did not include reason for borrowing [X]
(Explanation Required) Reasons for Borrowing a Private Dose _____ VFC vaccine shipment delay (order placed on time but delay in shippingreceipt) _____ VFC vaccine not useable on arrival (vials broken temperature monitor out of range) _____ Ran out of VFC stock between orders (provider orders not placed on time) [X] _____ Short-dated VFC vaccine dose was exchanged with private dose _____ Accidental use of a private dose for a VFC-eligible patient (human error) _____ OtherDocumented dose did not include reason for borrowing [X]
(Explanation Required)
B Enter date range for instances of borrowing reviewed in the borrowing report Note If ldquoDate of earliest instancerdquo is not available use the date of the last VFC Compliance Visit If ldquoDate of last instancerdquo is not available use the date of thecurrent VFC Compliance Visit
Date of earliest instance
Date of last instance
C Does borrowing appear to be a routine practice Note To determine whether borrowing is a routine practice assess frequency of and repeating reasons for borrowing Examples Frequent accidental use of incorrect stock exchanging short-dated vaccines or issues with ordering and shipment
Yes [X] No
Goal of this question Determine the reasons why the site is borrowing vaccine
If sites are using the Vaccine Borrowing Report review the reasons for borrowing to help document borrowed VFC andor private doses If they have not been documenting borrowing on this report (or any other form) estimate their borrowing practices If you do not know the date range for their borrowing use the last site visit date to the current visit date The use of ldquootherrdquo as the reported reason for borrowing should be rare if ever and would require explanation and follow up
Helpful information bull Look to see if they routinely maintain insufficient amounts or types of vaccine to support their public and private patients that leads to borrowing
bull Pay attention to borrowing cases documented as ldquoaccidentalrdquo Repetitive accidental borrowing may indicate an issue with ordering processes or insufficient staff training
bull Borrowing is not a place to document wasted or lost doses bull The time period of the borrowing may give you clues about the root cause Were the borrowed doses concentrated in a short period or spread out across several months or a year Are all vaccine types being borrowed or just one
bull If borrowing seems to be an issue discuss vaccine management ordering procedures
Resources bull Vaccine Borrowing Report on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfc formshtml)
bull Section 10 in the MnVFC Policies and Procedures Manual
Page 28 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 36
3 Documentation Vaccine Management Plan
Question 36 Physically review the providerrsquos Vaccine Management Plan to answer the question below
A Does the provider have a Vaccine Management Plan Yes No [X] (If no skip to question 37)
B Does the plan list the current Immunization Manager Vaccine Coordinator andback-up
Yes No [X]
C Does the plan address proper vaccine storage and handling practices Yes No [X]
D Does the plan specify vaccine receiving procedures Yes No [X]
E Does the plan contain procedures for what to do with vaccine in the event of an emergency
Yes No [X]
F Does the plan contain procedures for vaccine ordering Yes No [X]
G Does the plan address inventory control (example stock rotation) Yes No [X]
H Does the plan address how to handle vaccine wastage Yes No [X]
I Does the plan address staff training and documentation on vaccine managementstorage amp handling
Yes No [X]
J Does the plan contain a review date that falls within the last 12 months Yes No [X]
K Has the plan been signed by the individual responsible for its content Yes No [X]
Review CDC Requirement
VFC providers must develop maintain and implement a Vaccine Management Plan for routine and emergency vaccinemanagement The plan must contain the current Vaccine Coordinator and back-up proper storage and handling practicesshipping and receiving procedures emergency procedures procedures for vaccine ordering inventory control (eg stock rotation)how to handle vaccine wastage and staff trainingdocumentation on vaccine management storage and handling The plan must bereviewedupdated annually or more frequently if changes occur A ldquoreview daterdquo and signature are required on all plans in order tovalidate that they are current
Goal of this question Evaluate the sitersquos plan for vaccine management It is especially important that they have a plan for emergency management of their vaccine in the case of equipment failure or power outage Encourage all sites to read and sign the MnVFC Policies and Procedures Manual and complete the emergency plan or be able to show you a plan of their own
If the provider is not able to physically show you the plan at the time of the visit or if the recorded review date is not within the last 12 months you must mark that this requirement is unmet The Vaccine Management Plan is important in times of emergency and it should be easy to access by any staff member at any time Encourage them to post the plan and put a copy with the packing supplies
Helpful information bull Encourage the site to fill in the ldquoImmunization Managerrdquo and ldquoVaccine Coordinatorrdquo fields in the
MnVFC Policies and Procedures Manual for their own referencebull The emergency plan in the manual can be reviewed from last year and included in this yearrsquos manual (with an updated signature and date) if there have not been any changes
bull If information in the plan is outdated site staff will not be well equipped to safely manage vaccines in the event of a power-outage or other emergency situation
bull If their institutional policy is only reviewed and updated every 3-4 years (as many are) the staff may need to sign the MnVFC Polices and Procedure Manual to meet this requirement
Resource Routine Vaccine Management Plan and Emergency Vaccine Management Plan in the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 29
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 37
3 Documentation VIS amp VAERS
Question 37 Review the providerrsquos Vaccine Information Statements (VISs) and discuss providerrsquos VAERS process toanswer the questions below
A Does the provider have readily available up-to-date VISs for all ACIP-recommendedvaccines relevant to the populations it serves
Yes No [X]
B Does the provider make a VIS available for patientsparents before eachvaccination
Yes No [X]
C Does the provider know how and when to report clinically significant adverseevents using VAERS
Yes No [X]
Review CDC Requirement
VFC providers are required to distribute the current Vaccine Information Statements (VIS) each time a vaccine is administered and maintain records in accordance with the National Childhood Vaccine Injury Act (NCVIA) which includes reporting clinicallysignificant adverse events to the Vaccine Adverse Event Reporting System (VAERS) For a list of current VISs visit CDCrsquos Vaccine Information Statements (httpwwwcdcgovvaccineshcpvis) website
Gal of this question Ensure the site has the most current VISs and is giving them to each patientparent before administering the vaccine in compliance with the federal law Parents must be educated about the vaccine their child will receive and be aware of possible contraindications and side-effects in order to make well-informed decisions about their childrsquos health
Helpful information bull Ask to see the sitersquos VISs to determine if they have an active protocol for giving VISs to parents Review to make sure they are current Ask if they know where and how to report vaccine adverse events
Resources bull Section 3 in the MnVFC Policies and Procedures Manual bull CDC Vaccine Information Statements (wwwcdcgovvaccineshcpvisindexhtml) Site may sign up for email updates for the current list of VIS publication dates for the most up-to-date version
bull IAC Itrsquos Federal Law You must give your patients current Vaccine Information Statements (wwwimmunizeorgcatgdp2027pdf)
bull VAERS (httpsvaershhsgovindex)
Question 38
3 Documentation Anaphylaxis protocol
Question 38 Does the site have an anaphylaxis protocol which is clearly posted near the emergency kit
Answers (Choose one)
Yes No [X]
Review CDC Requirement
An anaphylaxis protocol must be clearly posted in the area where vaccines are administered
Goal of this question Make sure site is prepared for a severe allergic or anaphylactic reaction to a vaccine
Resources bull Section 11 in the MnVFC Policies and Procedures Manual bull IAC protocols Child and Teens (wwwimmunizeorgcatgdp3082apdf) and Adults (wwwimmunize orgcatgdp3082pdf)
Page 30 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
i
i i i - li i i i i i l
Section 4 Storage amp Handling Per Unit The goal of this section is to assess vaccine storage
2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet practices in each unit at the site MnVFC PIN ___________________
The 2017 MnVFC Storage amp Handling Per Unit Answer Sheet is a worksheet to document the answers to the questions in this section for each unit (combination or stand-alone) Fill in the answers to the questions in Section 4 on the answer sheet not in the questionnaire
The answer sheet has an abbreviated form of each question If you need further information on that question refer back to the full questionnaire Also if you find an area where the site is not meeting the requirements you will need to go back to that question on the 2017 MnVFC Site Visit Questionnaire to complete ldquoActions if Non- compliantrdquo section including the root cause analysis and follow-up sections If there is a problem in more than one unit make a note on the questionnaire which unit you are referring to in the Notes section
Important You must fully assess any unit that may be used to store VFC vaccines even if there are no VFC vaccines there on the day of the visit If there are no vaccines and the site is not documenting twice a day temperatures discuss the need to ensure the unit is maintaining stable temperatures by monitoring for one week before placing vaccines in the unit
Quest on number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
for the freezer and e co umn
Temperature Monitoring Dev refr gerator f the un
ce Quest ons Quest ons 4 3 4 7 must be answered separate y t s a combo Be sure to document responses n the appropr at
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
44D Data downloaded and reviewed routinely (eg weekly)
Yes No [O]
Yes No [O]
45A Certificate of Calibration Testing Yes No [X]
Yes No [X]
45B Date of calibration
45C Date certificate expires [X] Follow-up is required if expired [X] Follow-up is required if expired
45D Certificate contains all necessary items
Yes No [X]
Yes No [X]
46 Probe properly placed Yes No [X]
Yes No [X]
47A Two temperature readings per day
Yes No [X]
Yes No [X]
47B Time date and name (or initials) for each reading
Yes No [X]
Yes No [X]
47C Current temperature and minmax temperatures (if
Current ________deg Minimum ________deg Maximum _deg
Current ________deg Minimum ________deg Maximum _deg
Sections 5 and 6 contain questions about storage and handling site wide and inventory It is helpful to keep those questions in mind as you assess the individual storage units Think about dorm-style units expired vaccine vaccine supply room for vaccine stocking all the recommended vaccines and separation of stock if appropriate
NOTE The sections that follow require reviewers to validate responses by looking at vaccine storage units temperaturemonitoring equipment and the vaccine inventory inside a unit bull For section 4 use a separate Storage amp Handling Per Unit Answer Sheet for each unit to document the findings (combination
units using both sections can be documented on the same answer sheet) bull When an unmet requirement is identified return to this questionnaire to complete the ldquoActions if Non-compliantrdquo section for
that question bull After you complete one answer sheet for each unit return to the questionnaire to complete sections 5 and 6 using information
you gathered while assessing the units The questions in sections 5 and 6 (Storage amp Handling Site-Wide and Inventory) are notunit-specific but do require that the response be based on a thorough assessment of all the providersrsquo units
4 Storage amp Handling Per Unit
Description On the Storage amp Handling Per Unit Answer Sheet place a name that will allow you or someone else from your program to easily identify this unit in the event of follow-up We recommend using Brand + Location(example Samsung - Room 123) Save each Storage amp Handling Per Unit Answer Sheet with the Brand + Location in the file name
(example SamsungRoom123doc)
IPI Advisor Manual | February 2017 Page 31
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 41
4 Storage amp Handling Per Unit Storage Unit Build amp Use
Question 41 Below select the build and use of the vaccine storage unit you are assessing
Note to Reviewer Dorm-style units Do not add dorm-style units here Dorm-style units will be addressed in section 5 Units storing only private stock You must review these storage units even if they contain only private stockat the time of the visit because that vaccine could be administered to VFC patients
A What type of unit is this A Stand-alone B Combination
B Select use if stand-alone A Freezer B Refrigerator
Select use if combination A Use both sections to store vaccine B Use freezer section only to store vaccine C Use refrigerator section only to store vaccine
Goal of this question Identify the unit you are evaluating The description asks you to create a unique name for this unit so that you will be able to identify the same unit in future site visits Put this description on the top of the answer sheet (ie make and location)
Helpful information bull A stand-alone unit is either a refrigerator or a freezer It does not have both sections in the unit bull If there is a combination unit note if the site uses both the refrigerator and freezer or only one section of the unit to store vaccines CDC does not recommend the use of either section or the freezer section only of combination household units
bull If your site utilizes the separate stock method of vaccine management you must review storage units even if they contain only private stock at the time of the visit because there is a chance that those vaccines could be administered (borrowed) to VFC-eligible patients
Page 32 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 424 Storage amp Handling Per Unit CDC Recommended Storage Units
Question 42 Below document the grade of the vaccine storage unit you are assessing
Note to Reviewer Pharmaceutical Also called ldquopurpose-builtrdquo these units are designed by the manufacturer specifically tostore vaccines or other biological materials Commercial Although usually intended to store food and beverages commercial units are often larger and more powerful than the household units found in most homes Though these units are intended to meet thehigher demands of larger facilities these units are not specifically built for the storage of biologicalmaterials Household (non-commercialdomestic) These units are usually smaller than commercial units and areintended for use in small offices and in homes ndash typically for food storage However just like commercialunits they are not designed specifically for the storage of biological materials Such units are usually available in common home supply stores
Answers (Choose one)
Select grade A Pharmaceutical B CommercialHousehold
[O] CDC does not recommend the use of both sections or the freezer section only of combination commercialhousehold units
Review CDC Recommendation
CDC recommends the following vaccine storage unit types (in order of preference) pharmaceutical grade stand-alone orcombination units (preferred) householdcommercial stand-alone units householdcommercial combination units using therefrigerator section only
Goal of this question Assess the grade and type of each storage unit bull Pharmaceutical grade units may be stand-alone or combination units that are often metal may have glass in the door for viewing inside often have an external digital temperature display and are manufactured by medical companies
bull Commercial or household units often look like your kitchen appliance have vegetablemeat drawers in the unit and are manufactured by household appliance companies
bull Occasionally you might find a medical grade unit which is usually a commercialhousehold unit with a lock and 3-prong plug These are still considered household units because of their ability to maintain proper temperatures and air flow Studies show that household stand-alone units are better able to maintain consistent temperatures than their combination counterparts Combination household units used to store vaccine in both sections of the unit is no longer recommended and may be prohibited in the future Combination household storage units that are having difficulty maintaining a cold enough freezer temperature and a warm enough refrigerator temperature should be replaced or a separate stand-alone freezer should be purchased
For frozen vaccines the most cost effective solution is for the site to purchase a small stand-alone freezer The site may need time to budget for a stand-alone storage unit
Resources bull Replacing Combination Household Units Tip Sheet on IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml)
IPI Advisor Manual | February 2017 Page 33
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 434 Storage amp Handling Per Unit Temperature Monitoring Device in the Unit
Question 43 Determine whether there is a temperature monitoring device in this section of the storage unit andanswer the questions
A Is there a temperature monitoring device in this section of thestorage unit
Yes No [X] (If no skip to question 47)
B Who is responsible for supplying the temperature monitoring device in this section of the storage unit Provider
Review CDC Requirement
Certificates of calibration testing provide confidence that the temperature monitoring device is measuring temperaturesaccurately All units storing VFC vaccines must have a calibrated temperature monitoring device with a current and valid certificateof calibration testing All certificates must contain modeldevice name or number serial number date of calibration testing (report or issue date) and Instrument Passed testingInstrument in Tolerance (Recommended uncertainty = +-05ordm C (+-1ordm F))
Goal of this question Assess whether there is a temperature monitoring device in the unit If the unit is not being monitored at all call MDH at 651-201-5522 for guidance
Helpful information bull This question does not ask whether the temperature monitoring device is working or the characteristics of the device These issues will be addressed later in the questionnaire
bull For part B the provider is always responsible for supplying the temperature monitoring device Even if their thermometer or data logger was originally from MDH it is their responsibility to ensure it is functional and calibrated
Resources bull Section 8 in the MnVFC Policies and Procedures Manual
Page 34 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 444 Storage amp Handling Per Unit CDC Recommended Temperature Monitoring Device
Question 44 Assess the temperature monitoring device in this section of the storage unit to answer the questionsbelow
A Is the temperature monitoring device a continuous monitoring and recordingdevice (eg data logger)
Yes No [O] (Skip D)
B Does the temperature monitoring device have a probe in buffered material Yes No [O]
C Does the temperature monitoring device have a digital display that can beeasily read from the outside of this unit
Yes No [O]
D Is data downloaded and reviewed routinely Yes No [O]
Review CDC Recommendation
As of Jan 1 2018 all VFC providers must use continuous temperature monitoring devices (eg data loggers) to monitor vaccinesthat will be administered to VFC-eligible children Routine review and accessibility of temperature data is critical for determining whether vaccine has been properly stored and for assessing usability of vaccine that was involved in a temperature excursion Tomeet VFC Program requirements the device must also be equipped with bull A temperature probe bull An active temperature display that can be easily read from the outside of the unit bull The capacity for continuous monitoring and recording capabilities where the data can be routinely downloaded
The following are additional recommended features for these devices bull Alarm for out-of-range temperatures bull Current minimum and maximum temperatures display bull Low battery indicator bull Accuracy of +- 1degF (05degC) bull Memory storage of at least 4000 readings bull User programmable logging interval (or reading rate) recommended at a maximum time interval of every 30 minutes bull Use of a probe that best reflects the temperature of the vaccine (such as a buffered probe)
Goal of this question Assess the temperature monitoring device in the storage unit Note that these are all recommendations not requirements at this time
This is a great teaching opportunity for sites who do not currently have a continuous temperature monitoring device Beginning Jan 1 2018 all units that store MnVFC vaccine will be required to have a continuous temperature monitoring device (ie a data logger or a continuous temperature monitoring system) Unlike a minmax thermometer a continuous temperature monitoring device provides detailed information on all temperatures recorded at pre-set intervals For excursions it can provide information on when a temperature went out-of-range for how long and what the temperatures were This is essential information that vaccine manufacturers need to know to assess the viability of the vaccine following an excursion
Helpful information bull Sites are required to monitor and record temperatures twice daily however temperature excursions can easily occur in the 12 hours or longer between readings Continuous temperature monitoring can help manufacturers determine vaccine viability
bull Continue to encourage sites to document and evaluate minimum and maximum temperatures the storage unit reached since the last reading and respond appropriately to out-of-range temperatures
IPI Advisor Manual | February 2017 Page 35
The 2017 MnVFC Site Visit Paperwork Chapter 4
bull It is recommended that sites download and review data weekly Discuss with sites that reviewing temperature monitoring device data also includes responding appropriately if they identify out-of-range temps
bull There is sometimes confusion about the difference between a data logger and a continuous temperature monitoring system Here are some differences
Data Loggers Continuous Monitoring Systems Have an external display similar to thermometers May or may not have an external display Have a detachable probe Probe is usually attached to transmitter Need to be plugged into the computer or cradle to download information on a regular schedule
Wirelessly sends data to computer system
Create a file of data that needs to be saved on the computer
Data is stored within the system not a separate file
Doesnrsquot allow documentation of twice a day temperature checks in the file
May allow documentation of twice a day temperature checks within the system
More about the 2018 requirement for a continuous temperature monitoring device
Required Features bull The continuous temperature monitoring device must have Continuous monitoring and recording capabilities to track and record temperatures over time The capacity to routinely download temperature data to a computer (recommended at least weekly) or wirelessly transmit data Detachable probe in a bottle filled with a thermal buffer (eg bio-safe glycol) if the data logger needs to be detached in order to download data Active temperature display
Recommended Features bull MnVFC recommends continuous temperature monitoring devices with Alarm for out-of-range temperatures Accuracy within +-1degF (+- 05degC) Low battery indicator Display of current minimum and maximum temperatures Memory storage of at least 4000 readings User programmable logging intervals (eg the user can set how often the device records the temperature)
Note that these are all currently recommendations not requirements yet
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Page 36 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 45
Goal of this question Ensure the temperature monitoring device is properly calibrated The certificate of calibration testing means that the device has been tested and it is accurately measuring temperatures within established testing limits The certificate of calibration ensures that the device meets all the required components
Helpful information bull The provider is always responsible for having a current certificate of calibration (or copy) on-site
bull To be considered ldquovalidrdquo a certificate of calibration must contain these required elements Modeldevice name or number Serial number
4 Storage amp Handling Per Unit Certificate of Calibration Testing
Review CDC Requirement
Certificates of calibration testing provide confidence that the temperature monitoring device is measuring temperaturesaccurately All units storing VFC vaccines must have a calibrated temperature monitoring device with a current and valid certificateof calibration testing All certificates must contain modeldevice name or number serial number date of calibration testing (report or issue date) and Instrument Passed testingInstrument in Tolerance (Recommended uncertainty = +-05ordm C (+-1ordm F))
Question 45
Note to Reviewer
A
B
C
D
E
Review the certificate of calibration testing for the temperature monitoring device in this section of the storage unit and answer the questions below
bull How to determine certificate of calibration testing expiration date 1) Identify the certificate issuecalibration date 2) Apply the Immunization Program-required frequency for calibration testing Example If the
issuecalibration date is 12312013 and Immunization Program policy requires testing every twoyears the expiration date is 12312015
bull Certificates must include all of the below bull ModelDevice Name or Number bull Serial Number bull Date of Calibration Testing (Report or Issue Date) bull Instrument Passed testing (Instrument in Tolerance)
Is there a certificate of calibration testing for the temperature monitoring Yes device in this section of the storage unit No [X]
What is the date of calibration for the temperature monitoring device in this section of the storage unit
What is the certificatersquos date of expiration based on ImmunizationProgram policy (See note to reviewer to determine expiration date) [X] Follow-up is required if
certificate is expired
Does the certificate contain all the necessary items listed in the Note to Yes Reviewer No [X]
Who is responsible for supplying the current and valid certificate of Provider calibration for this temperature monitoring device
Date of calibration testing (report or issue date) Note If there is no expiration date the certificate expires 2 years from the date of calibration Whether the instrument passed or failed testing (or instrument in tolerancenot in tolerance)
bull Recommended element Documented uncertainty of +- 1degF [05degC]
If these elements are present the certificate is considered valid If the certificate contains information about the recommended element or the entity that issued the certificate that is helpful but not required
To determine if a certificate of calibration testing was issued by an appropriate entity check to see if the certificate indicates one or more of these items (this is the wording used to help sites evaluate if their calibration is accurate but is not required on the certificate itself to be considered valid)
bull Conforms to ISO 17025 bull Performed by an ILACMRA Signatory body accredited laboratory You can review this list of the ILAC MRA and Signatories (httpilacorgilac-mra-and-signatories)
bull Traceable to the standards maintained by NIST bull Meets specifications and testing requirements for the American Society for Testing and Materials (ASTM) Standard E2877 tolerance Class F (le 05 degC) or better
bull Includes reference to another acceptable accuracy validation method such as comparison to other traceable reference standards or tests at thermometric fixed points
Note CDC recommends that certifications be issued for the entire monitoring unit (detachable probe data logger etc) and not individual certificates for each component
IPI Advisor Manual | February 2017 Page 37
The 2017 MnVFC Site Visit Paperwork Chapter 4
For 45 E the provider is always responsible for supplying the current and valid certificate of calibration for a temperature monitoring device
bull Tip If the temperature monitoring device has a sticker on the back with the calibration date the site can usually call the company who calibrated the device and get a copy of the certificate if they donrsquot have one
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 46 4 Storage amp Handling Per Unit Probe Placement
Question 46 Is the probe properly placed in this section of the storage unit
Note to Reviewer ldquoProperlyrdquo means that the probe in a commercial or household unit is placed in a central area of the unitdirectly with the vaccines Probes should not be placed in the doors near or against the walls close to vents or on the floor of the unit The only allowable exemption related to this requirement is for providerswho have pharmaceutical storage units (built for vaccine storage) that have either (1) a built-intemperature monitoring device OR (2) a dedicated port for the probe that dictates the placement of theprobe
Answers (Choose one)
Yes No [X]
Review CDC Requirement
The probe must be placed in a central area of the section of the storage unit directly with the vaccines in order to properly measurevaccine temperature The probe should not be placed in the door near or against the walls close to vents or on the floor of theunit For pharmaceutical units with a built-in temperature monitoring device or a dedicated port for a probe that is not in thecenter of the section of the storage unit consult your Immunization Program for guidance on placement
Goal of this question Make sure the temperature monitoring device is in the best location to accurately measure the temperature of the vaccines stored in the unit
Helpful information bull The probe of the temperature monitoring device should be placed directly with the vaccines in the middle of the unit The ONLY allowable exception is for pharmaceutical storage units that have either a built-in thermometer or a dedicated port for the probe that indicates placement of the probe
bull Temperatures can vary within the unit especially household units bull Call MDH at 651-201-5522 if you have questions
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Guide (wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml)
Page 38 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 474 Storage amp Handling Per Unit Temperature Documentation
Question 47 Review the temperature documentation over the past three months for this section of the storage unit todetermine whether the provider has a process in place for properly documenting temperatures twice aday Answer the questions below
A Are there two temperature readings recorded for this section of the storage unit per day
Yes No [X]
B Is there a time date and name (or initials) recorded for each reading Yes No [X]
C What is the current temperature and minmax temperatures (if available) inthis section of the storage unit Use the reviewerrsquos thermometer if the providerrsquos temperature monitoringdevice does not have a current valid certificate of calibration testing or the probe is not properly placed in this section of the storage unit
Current Temperature Minimum Temperature Maximum Temperature Fahrenheit Celsius
D Based on your review of the providerrsquos recent temperature documentationincluding the current temperature is this section of the storage unitmaintaining appropriate temperatures
Yes No [X] Not enough information [X]
Review CDC Requirement
Vaccines must be stored under appropriate temperatures as described in the package inserts at all times Acceptable temperature ranges vary by vaccine type and the range is 36deg F and 46deg F (2deg C and 8deg C) and for frozen vaccines the range is -58deg F and +5deg F (shy50deg C and -15deg C) Exposure to temperatures outside of those included in the package inserts could affect vaccine viability andultimately could leave children unprotected against vaccine-preventable diseases In order to maintain awareness of storage unittemperatures and ensure that vaccines are being stored at appropriate temperatures at all times VFC providers are required to monitor and document temperatures for all vaccine storage units at least twice a day Temperature documentation must contain (1) at least two temperature readings per day (2) the time and date of each reading and (3) the name (or initials) of the personwho assessed and recorded the readings CDC also recommends that VFC providers record the minimum and maximumtemperatures of each unit once each workday (preferably in the morning)
Goal of this question Ensure the temperature is being monitored twice daily is within the required range and documented correctly Use your thermometer to check the temperature if the sitersquos temperature monitoring devicersquos probe is not properly placed or there is not a current certificate of calibration Place your thermometer in the unit at the beginning of the visit to allow sufficient time to reach an accurate temperature The purpose of using your thermometer is to ensure the vaccine is being stored at the proper temperature not to ldquovalidaterdquo their reading
Question 47 D is an assessment question based on information you have learned during your visit You might answer ldquonot enough informationrdquo if the unit is new and they donrsquot have at least three months of data or if the unit is only used as overflow and they are inconsistent with temperature monitoring Mark ldquoNordquo if you have reason to believe the storage unit is not maintaining temperatures properly
Helpful information bull All sites must document temperatures twice a day every day the site is open even if they have a data logger or continuous monitoring system
bull Sites can document the information electronically with some continuous monitoring systems as long as it can show what the current temp is the date time and initials of the person checking ndash this needs to be someone at the site ndash not checking remotely or centrally for a large site or system The site must be able to produce these records during their site visit Reviewing these files can be a challenge due to large volumes and lots of paper
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Temperature Logs on Managing Vaccine (wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml)
IPI Advisor Manual | February 2017 Page 39
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 484 Storage amp Handling Per Unit Temperature Excursions
Question 48 In the event that a temperature excursion(s) occurred in this unit within the last three months requestand review documentation of actions taken to determine whether the provider has a process for properlyaddressing excursions Answer the questions below
A Were vaccines in this unit exposed to out-of-range temperatures in the lastthree months (including today)
Yes No (If no skip to question 49)
B Did the provider quarantine and label vaccines as ldquoDo not userdquo Yes No [X]
C Did the provider place vaccine in a unit where it can be stored under properconditions if applicable
Yes No [X]
D Did the provider contact the Immunization Program to report theexcursion
Yes No [X]
E Was the manufacturer contacted for documentation supporting theusability of the vaccine
Yes No [X]
Review CDC Requirement
The provider must document all excursions and actions taken including the following (1) Quarantine and label vaccines as ldquoDO NOTUSErdquo (2) Place vaccines in a unit where they can be stored under proper conditions (3) Contact the Immunization Program to report an excursion and (4) Contact the vaccine manufacturer to obtain documentation supporting the usability of the vaccine
Goal of this question Address any out-of-range temperatures (temperature excursions) identified in reviewing the last three months of temperature logs or during the site visit If there were any out-of-range temperatures did the site respond appropriately to the situation This is a great opportunity to discuss what to do in the event of an excursion The Clinicians Storage and Handling Mishap Checklist is in the IPI Site Visit information folder and is a good review of the process
Helpful information bull Sites need to know that an excursion does not automatically mean that exposed vaccines are non-viable or unusable Exposed vaccines must be quarantined (marked ldquoDo Not Userdquo) and stored under proper conditions until they have received information from vaccine manufacturers regarding the viability of the vaccine
bull Sites must inform MDH when an excursion occurs
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Clinicians Storage and Handling Mishap Checklist (wwwhealthstatemnusdivsidepcimmunize ipivaxchklstpdf)
Page 40 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 49
Goal of this question Ensure proper placement of vaccines in the storage unit
Note These are all recommendations (best practices) not requirements
Helpful information bull Store vaccine in the middle of the compartment two to three inches away from the coils walls floor and cold air vent The temperature near the floor and walls of the unit differs from that in the middle of the compartment and the cold air vent can freeze refrigerated vaccines
4 Storage amp Handling Per Unit Vaccine Placement
Question 49 Look inside the unit to answer the questions below
A Are vaccines placed in the middle of the unit with space between vaccinesand the sideback of the unit to allow cold air to circulate
Yes No [O]
B Are vaccines stored in their original packages Yes No [O]
C Are there water bottles (for refrigerators) or frozen water bottles (forfreezers) in the unit
Yes No [O]
D Are vaccines store in the doors vegetable bins under or near cooling ventsor on the floor of the unit
Yes [O] No
E Is food being stored in the unit Yes [O] No
Review CDC Recommendation
Vaccines should be stored in their original manufacturer (or CDC centralized distributor) packaging They should be placed in the middle of the unit with space between the vaccines and the sideback of the unit to allow cold air to circulate Vaccines SHOULD NOT be stored in the doors vegetable bins or floor of the unit or under or near cooling vents and there should not be any food inthe unit Water bottles (for refrigerators) or frozen water bottles (for freezers) should be placed throughout each storage unit inorder to (1) stabilize or extend temperatures during a power outage and (2) to serve as physical blocks preventing the placementof vaccines in areas of the unit that are at higher risk for temperature excursions (such as in doors vegetable bins floor ornearunder cooling vents)
bull Vaccines should be kept in their original packaging to Protect them from light Help prevent medication errors by making labels easier to read Provide a moisture barrier that serves as insulation in case of an out-of-range temperature power outage door left open or mechanical failure Simplify managing vaccine inventory
bull Store water bottles in the doors on the floor and near the cold air vent in the refrigerator and frozen water bottles in the freezer to help maintain a stable temperature if there is a power failure and when the door is opened frequently Too many water bottles in the door can prevent the door from closing tightly Mark water bottles ldquoDo Not Drinkrdquo
bull Do not store vaccine in the door or drawers of the refrigerator or freezer Vegetable bins and crisper drawers should be removed from refrigerators or used to store other medical supplies or water bottles
bull If vaccine is stored in a household combination refrigeratorfreezer The top shelf should not be used for storing vaccine because the cold air vent blowing from the freezer will freeze vaccine located there If you must use the top shelf of this type of unit place water bottles underneath the cold air vent to prevent vaccine from being stored there It is recommended that only the refrigerator be used for vaccine storage and a separate stand-alone freezer be used to store frozen vaccine
bull Must not store food or beverages in the refrigerator or freezer because frequent opening of doors can lead to temperature variations that may affect vaccine viability There is also a risk of contaminating vaccines
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Guide (wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml) bull Vaccine Storage Tip Sheet on IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml)
IPI Advisor Manual | February 2017 Page 41
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 4104 Storage amp Handling Per Unit Disconnection from Power Source
Question 410 Ask the provider to demonstrate what measures are taken to ensure that vaccine storage units are notaccidentally physically disconnected from the power supply Which of the following describes the measure(s) taken on this unit
Note to Reviewer bull Large hospitals and healthcare systems may not have the ability to demonstrate labels on plugs or circuitbreakers In such cases verify that the practice has a comprehensive policy and standard operatingprocedures in place to prevent the vaccine storage unit from being physically disconnected from thepower supply
bull While back-up generators may ensure power to the overall facility this question ONLY addresses thevaccine storage unit being accidentally disconnected from the power source either through the plug orthe circuit breaker
Answers A ldquoDo not disconnectrdquo labels on the plug (Choose all that B ldquoWarningrdquo label on the circuit breaker box
apply) C Hard-wired (ie built-in) and has a ldquoDo not disconnectrdquo label on thecircuit breaker box D Hospital or large health care system with a comprehensive written policyand standard operating procedures detailing measures taken to preventvaccine storage units from being accidentally disconnected from the powersupply E No acceptable measures for preventing accidental disconnection frompower supply [X]
[X] The response is non-compliant if only A only B or E is selected
Review CDC Requirement
VFC providers must take steps to protect the power source for all vaccine storage equipment by means of having clear warninglabels on both the plug and the circuit breaker associated with all vaccine storage units Large hospitals and healthcare systems canmeet this requirement by demonstrating that they have comprehensive policies and standard operating procedures to preventvaccine storage units from being physically disconnected from the power supply
Goal of this question Decrease the chance that a vaccine storage unit will be accidently unplugged or power will be turned off while vaccine is in the unit This question addresses only what measures the site has taken to ensure the storage unit is not physically disconnected from its power source
If the site uses labels on the plugs and circuit breakers perform a visual inspection to assess whether the way the stickers are positioned make it clear and obvious to anyone that these units are not to be disconnected
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Do Not Unplug and Warning stickers are included in the folder or available to order on the For
Professionals Order Form (wwwhealthstatemnusdivsidepcimmunizeordermathtml)
Note Once you have completed the 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet for each unit return to the questionnaire to complete sections 5 and 6
Page 42 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
- -
Section 5 Storage amp Handling Site-Wide Question 51
5 Storage amp Handling Site Wide Discussion of Cost amp Quantity of Vaccine
Question 51 Have a discussion with the provider about the cost and quantity of VFC vaccines they are responsible for annually Address the points listed in the note to reviewer below
Note to Reviewer bull Vaccine Shipped (Required) Share the cost of VFC vaccines shipped to the provider in the last calendaryear to make sure the provider understands the contribution made by the VFC Program to their practiceFor new providers who do not have ldquocalendar yearrdquo data share either the actual cost of their currentinventory or use the cost of 10 VFC doses of each of the ACIP-recommended vaccines (approximately $7000) to help estimate their annual cost
bull Storage amp Handling (Required) Make sure the provider understands the cost of vaccines for which they are responsible when they make decisions about purchasing recommended vaccine storage and temperature monitoring equipment
Answer I have discussed with the provider the cost and quantity of vaccines ordered in the previous calendar year
Goal of this question Inform sites of the quantity and value of vaccines that they receive as part of the MnVFC program Providers often donrsquot realize the value of the vaccine in their unit This information is included on your clinic list and on the one page site-specific information
Helpful information bull This discussion must occur and the box on the questionnaire must be checked bull If there isnrsquot actual vaccine value information available tell the site that one vaccine order that includes a box of each of the ACIP recommended vaccines costs approximately $7000
bull MDH may not have specific information for individual sites if they receive vaccine from a central warehouse or pharmacy For those sites MDH will give you numbers for the whole system so you can discuss system wide data as appropriate If individual site information is also included it is usually just varicella-containing vaccines that must be shipped directly to the site
Question 52
5 Storage amp Handling Site Wide Dorm Style Units
Question 52 Determine whether the provider has any dorm-style units on site and answer the questions below
Note to Reviewer A dormitory-style refrigerator is a unit that has both refrigerator and freezer compartments behind a singleexterior door Dorm-style units also have an evaporator plate (cooling coil) which is usually located insidean icemaker compartment (freezer) within the refrigerator
A Does the provider have any dorm-style units that are used at any time tostore vaccines
Yes [X] No (Skip to question 53)
B Does the provider have sufficient space in existing compliant vaccinestorage units to store all vaccines without use of the dorm-style unit at any time
Yes No [X]
Review CDC Requirement
Dorm- and bar-style units are prohibited for vaccine storage Vaccines stored in dorm-style units are considered non-viable and must be returned to the centralized distributor CDC recommends the following vaccine storage unit types (in order of preference)pharmaceutical grade stand-alone or combination units (preferred) householdcommercial stand-alone unitshouseholdcommercial combination units using the refrigerator section only
Goal of this question Ensure no vaccine is stored in dorm-style units even for short periods of time Encourage them to label any units ldquoNo Vaccine Storage Allowedrdquo Vaccine stored in these units is considered non-viable If a site is using a dorm-style unit call the MnVFC program (651-201-5522)
Resource Section 8 in the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 43
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 535 Storage amp Handling Site Wide Storage Unit Space Availability
Question 53 Does the provider have sufficient room across storage units to store current stock as well as anyadditional stock acquired during peak season without overcrowding
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have sufficient storage space to accommodate vaccine stock at the busiest time of year without overcrowding
Goal of this question Ensure that sites have sufficient space in their units to maintain vaccines at the busiest time of year Overcrowding of vaccine limits air circulation and affects the unitrsquos ability to maintain stable temperatures
Helpful information bull Look for signs of overcrowding such as vaccines that are pushed up against the wall bins that are overflowing or storage units that are full during non-peak seasons
Discuss immediate actions if the unit is overcrowded Move some of their vaccines order less vaccine more frequently (once per month preferably) andor purchase another storage unit for overflow
Resource bull Section 8 MnVFC Policy and Procedure Manual
Page 44 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 545 Storage amp Handling Site Wide Expired Vaccines
Question 54 Look in each unit Are there expired vaccines in any of the vaccine storage units at this site
Answers (Choose one)
Yes [X] No
Review CDC Requirement
Vaccines should be rotated weekly and when a new shipment comes in so that longer-dated vaccines are stored behind shorter-dated vaccines If vaccines expire they can no longer be stored in the same storage unit with viable vaccines They must be placedin a container or bag clearly labeled ldquoDo not userdquo and separated from viable vaccines to prevent inadvertent use Expired vaccinemust be returned to the centralized distributor within six months of expiration
Goal of this question Ensure there is no expired vaccine in any storage unit
Helpful information bull Sites can prevent their stock from expiring by rotating vaccines every week andor when a new shipment arrives Longer-dated vaccines are stored towards the back of the unit and shorter-dated vaccines are up front
bull Pay attention to vaccines that expire within the next three months Consider transferring vaccine that will expire soon to another MnVFC-enrolled site that will use the vaccine preferably a site close by It is the transferring sitersquos responsibility to arrange the transfer of the vaccine Be sure to complete the MDH Vaccine Transfer Record form and send it to MDH If they are having difficulty finding a location to accept vaccine contact MDH
bull This is a great opportunity to educate sites about the MDH Nonviable Vaccine Form and the process for returning vaccine The VFC program does get some credit for taxes and fees on vaccine that is returned to the distribution center
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MDH Nonviable Vaccine Form and MDH Vaccine Transfer Record on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfcformshtml)
IPI Advisor Manual | February 2017 Page 45
The 2017 MnVFC Site Visit Paperwork Chapter 4
- -
-
Question 555 Storage amp Handling Site Wide Back up Thermometer
Question 55 Does the provider have a readily available back-up thermometer with a current and valid certificate ofcalibration testing
Note to Reviewer ldquoReadily availablerdquo means that the thermometer is available to perform twice-a-day monitoring for a unit asrequired CDC recommends that the back-up thermometer be maintained on site
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have a readily available back-up thermometer with a current and valid certificate of calibration testing Toprevent the certificates of calibration testing of the primary and back-up thermometers from expiring at the same time the date of calibration testing (or issue date) of the back-up thermometer should be different from the date of calibration testing (or issue date) of the primary thermometer As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meetsVFC program requirements
Goal of this question Ensure sites have one calibrated back-up thermometer onsite that is readily available in the event that the temperature monitoring device in unit fails transportation of vaccine is needed or there are other unexpected circumstances
Helpful information bull As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meets VFC Program requirements
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 56 5 Storage amp Handling Site Wide Preparation of Vaccine
Question 56 When does this provider prepare vaccine for administration to the patient
Note to Reviewer For mass vaccination clinics if one type of vaccine is offered providers may pre-draw up to 10 doses Ifusing pre-filled syringes pre-drawing also means activating the syringe by removing the needle guard orattaching a needle
Answers (Choose all that
apply)
Prepare dose immediately before administration Pre-draw doses for upcoming patients (in a regular clinicpractice) [O] Pre-draw up to 10 doses (in a mass-vaccination clinic) Pre-draw more than 10 doses (in a mass-vaccination clinic) [O] Other [O]
Review CDC Recommendation
CDC recommends preparing vaccines immediately prior to administration in order to assure viability of vaccine and prevent vaccinewastage Vaccines that are not administered immediately are at risk of exposure to temperatures outside of the required rangewhich can affect vaccine viability and ultimately can leave children unprotected against vaccine-preventable diseases
Goal of this question Discuss proper timing and preparation of vaccine(s) for administration These are recommendations not requirements
Helpful information bull Educate staff on the importance of preparing vaccine immediately before administration Pre-drawing of vaccines may lead to concerns related to vaccine viability potency sterility and wastage
Page 46 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 6 Inventory Question 61
6 Inventory Inventory Comparison
Question 61 Visually inspect storage units to determine if existing supply of vaccines proportionately mirrorspopulations served Choose the most accurate statement below
Note to Reviewer bull CDC recommends that providers maintain a four-week supply of inventory bull For this question do not take into account vaccine types that the provider does not order Here simply
make sure that overall the vaccines in the providerrsquos storage units are available in sufficient amounts toserve their patient population
Answers (Choose one)
The current vaccine inventory proportionately reflects the populations identified Only public stock is insufficient [X] Only private stock is insufficient [X] Both public and private stock are insufficient [X] Site uses the replacement method but does not appear to have enough vaccine for their population [X] Other [X]
Review CDC Requirement
VFC providers must order and stock routine vaccines in accordance with their patient population in order to prevent missedvaccination opportunities Having sufficient amounts of all stocks prevents the inadvertent use of VFC vaccines for non-VFC-eligiblepatients and vice versa
Goal of this question Assess whether the site is ordering appropriate quantities of vaccine for the population they serve at their site
Helpful information bull If the site sees 30 percent private-pay patients and 70 percent VFC the stock in their storage units should reflect that proportion If you donrsquot know you can ask the site about their population
bull This is meant to be a general assessment so in a big site if they have only a small amount of vaccine that may indicate an issue with vaccine management
bull CDC recommends smaller more frequent orders (ie monthly) rather than large orders to minimize the amount of vaccine loss if an incident occurs during shipment or in the storage unit Sites should not order more frequently than once a month
bull Sites using the replacement method will only have one stock but it should appear to be large enough for their population
bull Only assess the vaccine types that the site currently stocks in their unit We know there are sites that do not offer all ACIP-recommended vaccines for various reasons That issue will be addressed in question 62
IPI Advisor Manual | February 2017 Page 47
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 626 Inventory ACIP Recommended Vaccines
Question 62 Review providerrsquos current inventory to answer the questions below
A Does the provider offer all routine ACIP-recommendedvaccines for their patient population
Yes (Skip to question C) No [X] Offers all except varicella because direct ship ofvaccine is unavailable from manufacturer
B Which routine vaccines are NOT being offered DTaP Hepatitis A Hepatitis B HIB HPV Influenza Meningococcal
MMR Pneumococcal Polio Rotavirus TdapTd Varicella
C According to Immunization Program Policy does theprovider make accessible all non-routine ACIP-recommended vaccines for those VFC patients whomeet the criteria for receiving them
Yes (Skip to question 63) No [X]
D Which non-routine vaccines are NOT being offered Pneumococcal polysaccharide vaccine (PPSV23) Meningococcal Group B (MenB) Other
Review CDC Requirement
VFC providers agree to comply with immunization schedules dosages and contraindications that are established by the Advisory Committee on Immunization Practices (ACIP) for the vaccines identified and agreed upon in the Provider Agreement UNLESS bull In the VFC providers medical judgment and in accordance with accepted medical practice the VFC provider deems such
compliance to be medically inappropriate for the child bull The particular requirements contradict state law including laws pertaining to religious and other exemptions The VFC program entitles children to the following vaccines DTaP Hepatitis A Hepatitis B HIB HPV Influenza MeningococcalMMR Pneumococcal Polio Rotavirus TdapTd and Varicella VFC providers are also required to ensure that VFC-eligible children have access to non-routine vaccines as needed
Goal of this question Assess if the site is offering all the ACIP-recommended vaccines for the population they serve and these vaccines are in stock on the day of the visit It is important that every MnVFC-eligible child that comes to a providerrsquos office for an immunization is vaccinated
Helpful information bull The Advisory Committee on Immunization Practices (ACIP) is a group of medical and public health experts that develops recommendations on how to use vaccines to control diseases in the United States
bull Specialty providers are not required to offer all routine vaccines but should provide the vaccines appropriate for their population
bull If the site does not offer all routine ACIP-recommended vaccines appropriate for their population check the ldquoNordquo box in Part A then check the appropriate box(es) in Part B for any vaccines not offered Please contact MDH as this situation offers us the opportunity to provide education to the site
bull For non-routine vaccines they must either be in stock or the site must have an alternative protocol in the routine management plan that ensures these children have access when applicable
Resources bull IAC Diseases and Vaccines (wwwimmunizeorgvaccines) bull CDC Advisory Committee on Immunization Practices (ACIP) (wwwcdcgovvaccinesacipindexhtml)
Page 48 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 636 Inventory Separation of Stock
Question 63 Observe how the provider differentiates stock in each storage unit to answer the questions below
A Is it clear which vaccines belong to public stock andwhich belong to private stock
Yes No [X] Not applicable replacement site
B Is it clear which vaccines belong to VFC stock andwhich belong to UUAV stock
Yes No [X] Not applicable replacement site Not applicable not UUAV-enrolled site
Review CDC Requirement
In order to ensure that VFC vaccines are only administered to VFC-eligible children VFC providers that serve both VFC and non-VFCshyeligible children must maintain their vaccine inventories in such a way that they can clearly differentiate public stock from privatestock as well as VFC from other public stock
Goal of this question Assess whether the site can distinguish between MnVFC vaccine and private vaccine If they participate in the Uninsured and Underinsured Adult Vaccine (UUAV) program they should also be able to distinguish between MnVFC stock and UUAV stock Some sites use labels bins boxes etc to differentiate their stock If it is not clear how the site differentiates their stock discuss vaccine management with the staff For follow-up call MDH to discuss doing a follow-up site visit
Sites using the replacement method will not have separate stocksmdashthis is an approved alternative method for keeping track of vaccine
Resource bull Section 10 of the MnVFC Policy and Procedure Manual
IPI Advisor Manual | February 2017 Page 49
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
MnVFC Site Visit Storage and Handling Per Unit Answer Sheet 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet MnVFC PIN ___________________
Question number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
Temperature Monitoring Device Questions Questions 43 47 must be answered separately for the freezer and refrigerator if the unit is a combo Be sure to document responses in the appropriate column
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
All the questions on the Site Visit Storage amp Handling Per Unit Answer Sheet have been discussed previously in section 4 of this manual Use this sheet to record information about all the units at the site visit You will need one sheet for each unit If it is a combination unit (either pharmaceutical or household) you can record both sections on one sheet If they have stand-alone units use one sheet for each unit Do not enter the answers to the questions in section 4 of the questionnaire
If you need more information about any of the questions refer back to the main questionnairemdashthe complete question additional guidance including notes to the reviewer and the CDC requirements are there Also if the site is not meeting the requirement you will go back to the questionnaire to complete the ldquoActions if Non-compliantrdquo section including the root cause analysis and follow-up sections
When you have completed the assessment of all the storage units remember to go back to the questionnaire to complete sections 5 and 6
Page 50 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
ndash
ndash
MnVFC Provider Follow-up PlanThe goal of the Provider Follow-up Plan is to communicate with the site all of the VFC requirements any unmet requirements found during your site visit and the timeline for completing the required action The left hand column is a box to check for ldquoUnmetrdquo requirements
Helpful information bull The form can be used to review what the site is doing well and what they need to work on
bull For requirements that have specific documentation that needs to be sent to you use the notes section
2017 MnVFC Provider Follow-up Plan Site _______________________________________________ MnVFC PIN ____________ Date of Visit ___________
Thank you for participating in this MnVFC compliance site visit Please review this visit summary including follow-up actions and timelines for completion Unmet MnVFC requirements and recommendations have a checked box next to them The goal of this plan is to support you with successfully implementing the program and improving access to vaccines for VFC-eligible children
Unmet Question VFC Requirements Section 1 Changes to Key Staff
Q12 Change in the Medical Director Immunization Manager Vaccine Coordinator or back-upKey Staff must be communicated to the immunization program by emailing healthmnvfcstatemnus Changes Notes
Q12 Key staff must complete the annual training on VFC program requirements and print theAnnual Training certificate of completion Documentation Required Action
Staff that have not completed the MnVFC online training must complete it and send acopy of the certificate to the reviewer Training can be found on the MnVFC website (wwwhealthstatemnusvfc) Due date 1 month
Notes
Unmet Question VFC Requirements Section 2 Eligibility
Q21 Provider staff must possess a working knowledge of all VFC eligibility criteria and use thoseVFC Eligibility criteria to screen children prior to administering VFC vaccines
Categories Notes
bull This form provides documentation needed for follow-up actions when you send your thank you email
The second to last page of the Provider Follow-up Plan has a summary of the MnVFC program recommendations These are to remind the site about best practices they may want to improve upon even though they are not yet requirements of the program For example you could discuss the recommendation about storage units if they currently have a combination household unit and are using both sections
The last section is for your signature and the person you met with In most sites it will be the immunization manager or vaccine coordinator who signs the form unless the medical director attended the site visit You keep the original copy and the site will need to keep a copy for themselves
To be completed by the site visit reviewer
I acknowledge that a VFC site visit was performed on __________________ (visit date) The follow-up plan which includes a list of all current VFC program requirements and recommendations assessed during the visit and any required follow-up actions was provided at the end of the visit
Site visit reviewer
Phone
Reviewer Signature Date
To be completed by the provider
I acknowledge that our practice took part in the VFC site visit noted above I understand the findings of the visit and any required actions that must be taken by our office in order to meet VFC program requirements
Medical Director (or designee) Name Title
Medical Director (or designee) Signature Date
IPI Advisor Manual | February 2017 Page 51
The 2017 MnVFC Site Visit Paperwork Chapter 4
After the Site Visit Send a thank you email highlighting the unmet requirements documents you need from the site to resolve the issue(s) and the date you need them Make sure to include the link to the Site Visit Survey (httpssurveyvovicicomseashxs=56206EE334CE0B14)
Please refer to Chapter 3 for more information about future follow-up required after the visit including forms and documentation
Resource bull Sample Thank You letter on IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml)
Chapter 5
IPI Advisor Resource List MnVFC Program 651-201-5522
MnVFC wwwhealthstatemnusvfc
bull Separate Stock and Replacement Method Policies and Procedures Manuals bull Online trainings bull MnVFC Announcements sign up to receive them via email bull Ordering MDH vaccine bull MnVFC forms Screening forms Reporting forms Others MDH Nonviable Vaccine Form MDH Vaccine Transfer Record and Vaccine Borrowing Report
bull MnVFC promotional materials bull Immunization Billing Guidance for MnVFC and Immunization Billing Guidance for MnVFC Replacement Sites Immunization Practices Improvement Program (IPI) wwwhealthstatemnusdivsidepcimmunizeipi
bull IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml) bull IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml) IPI Resource Folder Contents (wwwhealthstatemnusdivsidepcimmunizeipiipifolderpdf)
Minnesota Immunization Information Connection (MIIC) wwwhealthstatemnusmiic
bull MIIC regions and regional coordinators
Clinical Practice MDH Immunization Program wwwhealthstatemnusimmunize
Got Your Shots News wwwhealthstatemnusdivsidepcnewslettersgys
MDH Immunization Information for Health Care Providers wwwhealthstatemnusdivsidepcimmunizehcp
bull Got Your Shots A Providers Guide to Immunization in Minnesota bull Vaccine protocols bull Forms for tracking patient immunizations bull Immunization schedules for Health Care Providers Immunization Action Coalition (IAC) wwwimmunizeorg
bull Ask the Experts bull VISs (Vaccine Information Statements and translations) bull Administration screening questions bull Medical management of vaccine reactions bull Order form for Californiarsquos Immunization Technique DVD Best Practices with Infants Children and Adults
Page 52 IPI Advisor Manual| February 2017
IPI Advisor Resource List Chapter 5
CDC ldquoPink Bookrdquo wwwcdcgovvaccinespubspinkbookindexhtml
CDC Advisory Committee on Immunization Practices (ACIP) wwwcdcgovvaccinesacip
CDC Vaccines and Immunizations wwwcdcgovvaccines
VAERS reporting httpvaershhsgovindex
Storage and Handling Got Your Shots Providers Guide ndash Managing Vaccine wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml
MnVFC Guide to Temperature Monitoring Devices wwwhealthstatemnusvfc
MDH Clinicianrsquos Vaccine Mishap Checklist wwwhealthstatemnusdivsidepcimmunizeipivaxchklstpdf
MDH Vaccine Storage Guide wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml
CDC Vaccine Storage and Handling Toolkit wwwcdcgovvaccinesrecsstoragetoolkit
You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Vaccine manufacturer phone numbers wwwcdcgovvaccinespubspinkbookdownloadsappendicesFcontact-info-manufactpdf
IAC Checklist for Safe Vaccine Handling and Storage wwwimmunizeorgcatgdp3035pdf
IAC Donrsquot Be Guilty of These Errors in Vaccine Storage and Handling wwwimmunizeorgcatgdp3036pdf
Additional Resources Print materials from MDH ndash order forms wwwhealthstatemnusdivsidepcimmunizeordermathtml
Vaccine Education Center ndash Childrenrsquos Hospital of Philadelphia wwwchopeduservicevaccine-education-centerhomehtml
California Department of Public Health ndash Interactive training on vaccine administration and storage and handling handout on transporting vaccine and how to package wwwezizorg
IPI Advisor Manual | February 2017 Page 53
IPI Advisor Resource List Chapter 5
CDC vaccine price list wwwcdcgovvaccinesprogramsvfcawardeesvaccine-managementprice-listindexhtml
Vaccine Information Statements (VIS) wwwcdcgovvaccineshcpvisindexhtml
CEU Opportunities CDC Immunization Education and Training wwwcdcgovvaccinesedindexhtml
Immunization You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Page 54 IPI Advisor Manual| February 2017
- Introduction
-
- Welcome to the Immunization Practice Improvement (IPI) Program
- Contact Information
-
- Chapter 1
- Requirements to Participate in the MnVFC Program
- Vaccines for Children Program
- Chapter 2
- Reimbursement for MnVFC Visits
- Types of Visits
- Your MnVFC Clinical CoordinatorPlanner
- New IPI Advisor Training Requirements
- Your Role as an IPI Advisor
- Reasons MDH Would Do All or Part of a Visit
- Chapter 3
- Future follow-up
- Conducting the Visit
- Preparing for the Visit
- Information for the Visit
- Site Visit Checklist
- Scheduling the Visit
- Chapter 4
- After the Site Visit
- MnVFC Provider Follow-up Plan
- MnVFC Site Visit Storage and Handling Per Unit Answer Sheet
- Section 6 Inventory
- Section 5 Storage amp Handling Site-Wide
- Section 4 Storage amp Handling Per Unit
- Section 3 Documentation
- Section 2 Eligibility
- Section 1 Provider Details
- The Site Visit Reviewer Legend
- MnVFC Site Visit Questionnaire
- Required Paperwork for Site Visits
- Chapter 5
-
Site Visits Chapter 3
Once identified the root cause should be documented in the questionnaire including a brief explanation of why you chose that cause This allows for follow-up with the site and a way to help find improvements to meet the unmet requirement Complete any immediate on-site action These often require providing education and resources for the site Mark the box for each action taken If you provide additional resources or information you can use the notes section to indicate the additional items
ldquoFuture follow-uprdquo are actions the site needs to take to meet the requirements of the program Wersquoll go over more specific information about the site visit questionnaire in Chapter 4
Performing the Site Visit
As you become familiar with the MnVFC program and develop a relationship with your sites you will develop a visit pattern that works for you Here is one possible sequence for conducting MnVFC site visits
bull When you arrive at the site if you have a business card it is helpful to provide it to the front desk staff person
bull When you meet with the immunization manager andor vaccine coordinator introduce yourself and explain the expectations for the visit
bull Ask to see the temperature monitoring device(s) It must have a current certificate of calibration and the probe must be properly placed in the unit If it does not meet the requirements place your thermometer in the unit at the beginning of the visit so that it has sufficient time to reach an accurate temperature by the time you complete your assessment of the storage units
bull 2017 MnVFC Site Visit Questionnaire Ask all of the questions You may have to modify the order of the questions based on what is best for the site When you get to the storage and handling section (section 4) use the answer sheet(s) to document the answers to the questions for each storage unit that stores vaccine (MnVFC or private) Do not write answers in the questionnaire unless there is an unmet requirement Be sure to ask if there is vaccine stored anywhere else at any time at this location This includes a co-located pharmacy If so these additional units will need to be assessed as well If the site has a combination refrigeratorfreezer household unit and is using both sections discuss with them the recommendation (and probable future requirement) to have a separate freezer Refer to MDH if they have further questions or need more information Be prepared to address any storage and handling mishaps that you may find A copy of the
Clinicianrsquos Vaccine Mishap Checklist is with your visit materials and the Emergency Response Worksheet is in the MnVFC Policy and Procedure Manual If you are unsure how to handle the problem call the MnVFC program at 651-201-5522 during or after the visit
Page 14 IPI Advisor Manual | February 2017
Site Visits Chapter 3
Ending the Visit bull Fill out the two copies of the 2017 MnVFC Provider Follow-up Plan (or ask them to make a copy once it is completed for their records) Indicate if they have not met the requirement by checking the box in the ldquoUnmetrdquo column If they are not meeting requirements check the required actions Review the plan with them reinforcing the positive things they are doing as well as reviewing the required follow-up action(s) Give the site a copy of the Provider Follow-up Plan Keep the signed copy of the Provider Follow-up Plan to submit with your paperwork Do not leave a copy of the Site Visit Questionnaire at the site
bull Let them know you will be sending a thank you email that will summarize the site visit Included in the email will be a survey link you would appreciate them completing regarding the visit
After the Visit bull Send the site a thank you email There is a template thank you letter on the IPI Advisor Site Visit Materials (wwwhealthstate mnusdivsidepcimmunizeipisvmaterialshtml) page Be sure you include the issues that you identified and the timeline for their completion as well as the good things you found at the visit In the template letter be sure to include the survey link The survey is very brief ndash a few questions and space to write comments
bull Either transfer your MnVFC Site Visit Questionnaire and MnVFC Site Visit Storage amp Handling per Unit Answer Sheet information to the fillable version or submit the handwritten form to MDH
Documentation of the Visit
Paperwork must be submitted to MDH within 10 days of the visit in order to meet the federal VFC programrsquos reporting requirements Do not wait to complete your follow-up before submitting the site visit paperwork
Send the following documents to MDH bull 2017 MnVFC Site Visit Questionnaire (includes the cover sheet) bull 2017 MnVFC Site Visit Storage amp Handling per Unit Answer Sheet (one for each unit) bull 2017 MnVFC Provider Follow-up Plan (original signed plan)
Submit site visit materials to bull Email healthIPIinquiriesstatemnus (preferred) bull Mail IPI Program Specialist
Immunization Practices Improvement Program Minnesota Department of HealthPO Box 64975St Paul MN 55164-0975
IPI Advisor Manual | February 2017 Page 15
Site Visits Chapter 3
Future follow-up Follow-up is an important component of the site visit It helps us ensure that the unmet requirements have been corrected The questionnaire has different time periods for follow-up depending on the question Do not wait to complete your follow-up before submitting the site visit paperwork
When you complete the Follow-Up Form make sure to keep a copy for yourself MDH also keeps track of follow-up required and will remind you if follow-up has not been completed by the deadline Most follow-up can be done with a phone call or email In-person follow-up is rarely required and should be discussed with MDH before scheduling a follow-up visit
All requirements that need follow-up are identified with a [X] on the site visit paperwork and are listed on the MnVFC Provider Follow-up Plan
bull Follow-up with the site to see how they have resolved the unmet requirements bull Document your follow-up on the Follow-Up Form available on the IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml) page If follow-up was done via letter or email a copy can be attached to the Follow-Up Form
bull Send your Follow-Up Form to MDH (healthIPIinquiriesstatemnus) with supporting documents and emails
bull If a site is not responding to your requests regarding follow-up contact your MnVFC clinical coordinatorplanner They can help with additional follow-up as needed
Page 16 IPI Advisor Manual | February 2017
Chapter 4 The 2017 MnVFC Site Visit Paperwork This chapter will go through the required MnVFC site visit paperwork with notes about information or resources to help the site address questions or issues that may arise during the visit
The MnVFC site visit paperwork is available on the IPI Advisor Site Visit Materials (wwwhealthstate mnusdivsidepcimmunizeipisvmaterialshtml) page
Please download the paperwork shortly before your visit as there may be updates and changes and this will be the most up-to-date version of the questionnaire We will send out a Workspace message with major changes
Required Paperwork for Site Visits bull 2017 MnVFC Site Visit Questionnaire bull 2017 MnVFC Storage amp Handling Per Unit Answer Sheet ndash one for each unit assessed during site
visit bull 2017 MnVFC Provider Follow-up Plan ndash with provider signature
Make sure to include the sitersquos PIN on all your paperwork Please complete and submit your site visit paperwork as soon as possible after your visit It may be helpful to schedule some time into your calendar to complete your paperwork in the days following your visit Once you have completed the post-visit follow-up send in the Follow-Up Form with documentation of the follow-up actions Please do not wait until you have completed your follow-up before sending in your initial paperwork
MnVFC Site Visit Questionnaire The questionnaire includes these six sections 1 Provider details 2 Eligibility 3 Documentation 4 Storage amp handling per unit 5 Storage amp handling site-wide 6 Inventory
IPI Advisor Manual | February 2017 Page 17
Page 18 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
The Site Visit Reviewer Legend The legend explains the formatting of the 2017 questionnaire This includes information that will be helpful in completing the site visit
Site Visit Reviewer Guide Legend
Section Number Content Area
Question number This area will always contain the text of the question
Note to reviewer The note to reviewer contains information that is necessary for properly asking and assessing responses tothe question above This may include definitions of terms requirement details and other helpful tips
Answers This field will contain all the possible answer choices for this question For most questions answer choiceswill be followed by the markings below
Answer choices marked with an [X] indicate that this specific answer choice is non-compliant with a CDC requirement Answer choices marked with an [O] indicate that this specific answer choice is not aligned with a CDC
recommendation
Review CDC RequirementRecommendation
This field will be populated with the CDC requirementrecommendation associated with the given question
Actions if Non-Compliant
Root Cause Analysis As part of the site visit reviewers are required to assess and understand the reasons why a provider office isnon-compliant with VFC program requirements ndash this is a root cause analysis Reviewers must choose theone root cause that they believe most contributes to the non-compliance Upon establishing the root causethe reviewer must provide a clear explanation of hisher findings
Immediate Action These are actions that CDC requires reviewers to take on site during the visit
Future Follow-up These are future follow-up actions (with designated due dates) that are required of the reviewer andorprovider to remedy non-compliance Reviewers must complete all follow-up in accordance with CDCestablished deadlines
Notes Information you want the VFC program to be aware of or that explains your answer in detail
bull Note to reviewer These are notes to help you understand what the question is asking for and to clarify things you might want to know when asking or rephrasing the question
bull Answers This section helps you to know when the answer does not meet the CDC requirement [X] or recommendation [O] Whenever an answer with a [X] is checked the ldquoActions if Non-compliant section must be completed The recommendations are usually good teaching points about best practices andor future requirements of the VFC program
bull Review the CDC RequirementRecommendation This section provides a specific outline of the requirement or recommendation to give you information to use in talking with the site staff
bull Actions if Non-Compliant This section describes what to do if the site is not meeting a requirement Root cause analysis This section asks you to probe beyond the surface to find what is driving the non-compliance It is intended to help uncover reasons for recurring non-compliance issues identify additional training needs and inform reviewer follow-up actions Select only one root cause and explain the particular circumstances in the space ldquoExplanation of root causerdquo line provided If there appear to be multiple issues choose the one that most contributes to the non-compliance and describe all factors in the explanation Immediate actions A list of actions to take during the site visit to address the issue Future follow-up A list of actions to take after the site visit by the set deadline
bull Notes This section can be used for notes to yourself or to MDH
IPI Advisor Manual | February 2017 Page 19
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 1 Provider Details Questionnaire Coversheet
The first page of the questionnaire collects the demographic information for the site You can use this page to help prepare for the visit Most of the demographic information about the site should be on the site-specific document you received with your clinic list You will validate that this information is current at the time of the site visit It also helps to know if this is a separate stock site or a replacement site before the visit so you can bring a copy of the appropriate MnVFC Policies and Procedure Manual
2017 MnVFC Site Visit Questionnaire Date of visit _____________ Date forms sent to MDH ______________
Site Information
Site name MnVFC PIN
Address Separate Stock Replacement
City ZIP County
Medical Director Email
Immunization Manager Phone
Vaccine Coordinator Phone
Vaccine Coordinator back-up Email
Point of contact Phone
Personnel at site visit
On this page bull The date of the visit and the date when you send these forms to MDH This information helps us track the timeliness of our review and data entry process
bull The vaccine management method used by the site (replacement or separate stock) bull The name and email of the medical director (ideally this is the person who signed the MnVFC
Program Provider Agreement)bull Contact information for the immunization manager vaccine coordinator vaccine coordinator back-up and point-of-contact for this visit The immunization manager vaccine coordinator vaccine coordinator back-up roles are
described in the MnVFC Policies and Procedure Manual The vaccine coordinator back-up may be the immunization manager or another staff person depending on the size of the site and available personnel The Point of Contact is the person you set up the appointment with signs the Provider Follow-
up Plan and receives the follow-up email This may be one of the people listed above
The Post Visit Steps section is a reminder to you about what needs to done after the visit The Education on Immunization Best Practices for Sites section reminds you to provide the resource folder to the site
Page 20 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 12
1 Provider Details Changes to Key Staff
Question 12 Ask the provider about changes to key staff to answer the questions below
A (Choose all that
apply)
At the time of the visit is the Medical Director the same individual that signed the ProviderAgreement and are the Immunization Manager and Vaccine Coordinator the same asthose last reported to the program
Yes No the Medical Director has changed No the Immunization Manager has changed No the Vaccine Coordinator has changed
B (Choose one)
Were all changes communicated to theImmunization Program according to yourprogramrsquos policy
Yes or no staff changes No [X]
C (Choose one)
Based on review of the trainingdocumentation have the current Immunization Manager Vaccine Coordinator and back-up completed all required training
Yes No [X]
Review CDC Requirement
All changes in key staff must be communicated to the Immunization Program in the manner and timeframe defined by theImmunization Program Key staff include the Medical Director or equivalent who signed the Provider Agreement the Immunization Manager Vaccine Coordinator and the back-up VFC providers are required to ensure that all key staff are fully trained on VFC program requirements at all times All training must be documented
Goal of this question Determine if there are new staff in key positions at the site and to make sure staff are properly educated about the MnVFC program A This information can help you determine the level of knowledge and experience the staff have with the MnVFC program Follow-up throughout the visit can be tailored for various levels of staff experience Likewise you may identify additional training needs for new staff
B When sites notify us of changes in key personnel we update their information in MIIC and on the clinic lists We also send the new staff information for completing the online training and direct them to read the appropriate MnVFC Policies and Procedures Manual If the answer to this part is no update the demographic area of the questionnaire and inform the staff that in the future they must notify the MnVFC program (via email or phone) if the immunization manager or vaccine coordinator changes Resource Section 12 of the MnVFC Policies and Procedures Manual
C Annual training must be verified by looking at the certificates for the online training If the answer to this part is no refer the staff to complete the appropriate MnVFC online training found on the MnVFC website (wwwhealthstatemnusvfc) for their program (separate stockreplacement) for the current year and send you a copy of the certificate within 30 days
Resource bull Sections 12 and 14 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 21
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 2 Eligibility Question 21
Goal of this Question Assess whether staff correctly understand which patients are eligible for the MnVFC program Screening ensures that eligible children receive the vaccines that they are entitled to receive under the MnVFC program and helps to prevent fraud or abuse of the program
Children 18 years and younger in these
categories can receive MnVFC vaccine at any enrolled site bull Uninsured bull Enrolled in a Minnesota Health Care Program (MHCP) Medical Assistance (MA) or MinnesotaCare bull American Indian or Alaskan Native
The following categories are considered underinsured and are only MnVFC-eligible at local public health (LPH) Federally Qualified Health Centers (FQHC) Rural Health Centers (RHC) Indian Health Services (IHS) and tribal health clinics
bull Has health insurance that does not cover one or more vaccines as can be the case with newly licensed vaccines that arenrsquot yet covered (MnVFC-eligible for non-covered vaccines only)
bull Has health insurance that caps vaccine coverage at a certain amount Once that amount is reached the child is MnVFC-eligible
Children with insurance that does not cover vaccines until a deductible has been met are considered to be fully insured and are not MnVFC-eligible
Helpful information bull Sites are not required to verify the patientrsquos response to the screening questions For example if a patient states they lost their insurance the site does not need to call the patientrsquos insurance company to confirm
If the site cannot correctly describe the eligibility categories provide educational materialsresources on MnVFC eligibility requirements
Resources bull Patient Eligibility Screening Record on MnVFC Forms (wwwhealthstatemnusdivsidepc immunizemnvfcformshtml)
bull Section 1 of the MnVFC Policies and Procedures Manual
2 Eligibility VFC Eligibility Categories
Question 21 Was the individual responsible for determining patient VFC eligibility able to explain all the factors(including age) that make a child eligible to receive VFC vaccines
A Patient is less than 19 years of age Yes No [X]
B Patient is Medicaid-eligible Yes No [X]
C Patient is uninsured Yes No [X]
D Patient is underinsured Yes No [X]
E Patient is American Indian Yes No [X]
F Patient is Alaska Native Yes No [X]
Review CDC Requirement
VFC providers must possess a working knowledge of all VFC eligibility criteria and use those criteria to screen children prior toadministering VFC vaccines In order to receive VFC vaccine a patient must be under the age of 19 and must be at least one of the following (1) Medicaid-eligible (2) Uninsured (ie child has no health insurance) (3) Underinsured (ie child has health insurancebut coverage does not cover any or certain vaccines ndash underinsured children may only receive VFC vaccines in FQHCRHC ordeputized VFC provider offices and only for vaccines not covered by insurance) and (4) American Indian or Alaska Native (AIAN)
Page 22 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 22
2 Eligibility Billing Practices
Question 22 Is the individualdepartment responsible for billing able to clearly explain how they bill for both the costof vaccine and the vaccine administration fee for each of the eligibility categories below
A Medicaid-eligible Cost of Vaccine Do not bill ndash provided by VFC Admin Fee Bill Medicaid
Yes No [X]
B Uninsured Cost of Vaccine Do not bill ndash provided by VFC Admin Fee If billing can bill patient
Yes No [X]
C Underinsured Cost of Vaccine Do not bill ndash provided by VFC through FQHCsRHCs or deputized providers only all other providers cannotprovide VFC vaccine to underinsured patients Admin Fee If billing can bill patient
Yes No [X]
D American IndianAlaska Native(AIAN)
Cost of Vaccine Do not bill - provided by VFC unless patient is fully insured and parent chooses to use insurance Admin Fee If patient is Medicaid-eligible bill Medicaid if billingand patient is uninsuredunderinsured can bill patient if parentchooses to use private insurance for cost of vaccine billpatientinsurance
Yes No [X]
E Do individuals responsible for billing have access to the results of eligibility screening toensure proper billing
Yes No [X]
Review CDC Requirement
VFC providers must adhere to proper billing practices for vaccine administration fees and clearly understand that VFC vaccine isprovided at no cost to both the VFC provider and eligible children At no time should billing occur for the cost of VFC vaccine Whenadministering VFC vaccine providers should never bill two different ldquopayersrdquo (ie patient Medicaid insurance) for the samevaccine administration fee amount For Medicaid-eligible children Medicaid should be billed for the vaccine administration fee Forall other VFC-eligible populations the patient may be billed within the stateterritory cap established by the Centers for Medicareand Medicaid (CMS) However patients cannot be turned away or reported to collections for inability to pay the administration fee
Goal of this question Determine if the staff correctly understand how to bill patients that are eligible for the MnVFC program Billing appropriately ensures that children can receive low cost immunizations and the site is in compliance with the VFC program
bull If there is any indication that sites could be billing insurance companies or parents for VFC vaccines this should be investigated further
bull Most sites in Minnesota will bill Medicaid with the SL modifier ndash which indicates this is a Medicaid claim
bull The main point is to ensure the site is not billing uninsured children for VFC vaccine and are not charging them more than $2122 per vaccine for the administration fee
bull Non-compliance is usually unintentional and may be resolved with some training In rare cases it could be a glimpse into a larger problem where a site is intentionally billing for financial gain
bull If you think the site is billing inappropriately it is the responsibility of the IPI advisor to report concerns to MDH staff for further assistance
Resources bull Immunization Billing Guidance for MnVFC (wwwhealthstatemnusdivsidepcimmunizemnvfc billingtipshtml) or Immunization Billing Guidance for MnVFC Replacement Method Sites (www healthstatemnusdivsidepcimmunizemnvfcreplacementbillingtipsrephtml)
bull Section 2 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 23
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 232 Eligibility Vaccine Administration Fee
Question 23 Document the actual vaccine administration fee charged to non-Medicaid VFC-eligible patients (confirmwith billing department)
Answers Fee $ [X] Follow-up is required if the provider charges more than the fee cap establishedby the Centers for Medicare and Medicaid (CMS) for your stateterritory ($2122)
Review CDC Requirement
The VFC providerrsquos vaccine administration fee for non-Medicaid VFC-eligible children must not exceed the stateterritory vaccineadministration fee cap established by the Centers for Medicare and Medicaid (CMS) For current fee caps refer to Medicaid Program Payments for Services Furnished by Certain Primary Care Physicians and Charges for Vaccine Administration Under theVaccines for Children Program Final Rule (httpwwwgpogovfdsyspkgFR-2012-11-06pdf2012-26507pdf)
Goal of this question Ensure that sites are not charging more than the federal allowable vaccine administration fee of $2122
bull The Centers for Medicaid and Medicare (CMS) establishes a maximum fee that sites can charge to non-Medicaid-eligible VFC patients in each stateterritory for vaccine administration Health Plans usually negotiate this fee with the site but Medicaid will not pay more
bull If a parent cannot pay the vaccine administration fee the patient cannot be turned away or reported to collections VFC-eligible children must be vaccinated regardless of their ability to pay
bull If the person with whom you are conducting the site visit does not know the exact fee charged to non-Medicaid VFC-eligible patients ask to speak to someone who can verify the exact amount
bull If they are charging more than $2122 for the administration fee ndash please contact MDH staff for help with addressing this situation
Resources bull Immunization Billing Guidance for MnVFC (wwwhealthstatemnusdivsidepcimmunizemnvfc billingtipshtml) or Immunization Billing Guidance for MnVFC Replacement Method Sites (www healthstatemnusdivsidepcimmunizemnvfcreplacementbillingtipsrephtml)
bull Section 2 of the MnVFC Policies and Procedures Manual
Page 24 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 3 Documentation Question 31
3 Documentation Eligibility Screening amp Documentation
Question 31 To answer the questions below the provider must clearly demonstrate the patient intake processReview a minimum of 10 records that contain an immunization visit within the last 6 ndash 12 months
Note to Reviewer Criteria for Record Selection 1) Record selection must be completely random and the provider must not know prior to the visit which
records will be reviewed 2) Patient must have been 0-19 years of age at the last visit (Note Records of 19-year-old patients may
allow you to see if VFC vaccines are being used beyond the allowable age) 3) Must review a mix of public and private-pay patients (if applicable)
A Does the provider have a process that ensures that patients are screened forVFC eligibility at each visit and that screening results are documented at each visit
Yes No [X] (If no skip question F)
B Does the providerrsquos process ensure that staff administering vaccine know which vaccine stock to select from prior to drawing the vaccine
Yes No [X]
C Number of records reviewed If fewer than 10 records are reviewed select the reason why Provider does not have 10 patient records with immunizations in last 12 months
D Do all records contain date of the immunization visit and patientrsquos date of birth Yes No [X]
E Do all records contain the patientrsquos specific eligibility status associated with thedate of the immunization
Yes No [X]
F Do any of the providerrsquos records contain any evidence that the patient received vaccine for which they were not eligible
Yes [X] No
Review CDC Requirement
VFC providers must screen for and document VFC eligibility at each immunization visit Documentation must include the date of the visit and the childrsquos specific eligibility category VFC providers must use screening results to ensure that only VFC-eligible children receive VFC vaccine and that administration fees are billed for as appropriate Eligibility status must be readily available to staff administering vaccine prior to selecting which vaccine stock to use
Goal of this question Ensure the site is screening for eligibility and documenting the eligibility category in the medical record
Review a minimum of 10 records from within the last 6-12 months where the patient received an immunization You must review a mix of public and private pay patients (if applicable)
Random selection is important If the staff have pre-selected records for review do not use and identify additional randomly selected records to review
Helpful information bull Discuss upgrading the electronic health record to make documentation of VFC eligibility screening a required field Documenting eligibility screening in the immunization field promotes better MIIC data
bull Q 31 B Sites using the replacement method of vaccine management only have one stock so you will answer ldquoYesrdquo to this question
Resources bull Patient Eligibility Screening Record on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfcformshtml)
bull Section 1 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 25
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 32
3 Documentation Vaccine Dose Documentation
Question 32 Review a minimum of 10 patient immunization records from the last six months (or 12 months ifnecessary) to assess compliance with documentation requirements set forth by Statute 42 US Code 300aa-25 (See note to reviewer below)
Note to Reviewer Criteria for Record Selection 1) Record selection must be completely random the Provider must not know prior to the visit which records
will be reviewed 2) Patient must have been 0-19 years of age at the last visit (Note Records of 19-year-old patients may allow
you to see if VFC vaccines are being used beyond the allowable age)
Records are Compliant if they Contain ALL the Below Elements
bull Address of clinic where vaccine was administered bull Publication date of VIS bull Name of vaccine administered bull Name of vaccine manufacturer bull Date vaccine was administered bull Lot number bull Date VIS was given bull Name and title of person who administered the
vaccine
A Number of records reviewed
B Number of records that contain ALL required documentation elements
If fewer than 10 records are reviewed select the reason why Provider does not have 10 patient records with immunizations in last 12 months
[X] Follow-up isrequired if one ormore records do not meet requirements
Goal of this question Assess whether the site is documenting all required information in each patientrsquos medical record for every vaccine dose administered in accordance with the National Childhood Vaccine Injury Act
Resources bull Section 6 of the MnVFC Policies and Procedures Manual bull National Vaccine Injury Compensation Program (wwwhrsagovvaccinecompensation)
Question 33
3 Documentation Record Retention
Question 33 Is the provider able to demonstrate (preferred) or clearly describe how they maintain historical VFCeligibility documentation for three years
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers are required to maintain all records related to the VFC program for a minimum of three years (or longer if requiredby state law) and upon request make these records available for review VFC records include but are not limited to VFC screening and eligibility documentation billing records medical records that verify receipt of vaccine vaccine ordering records and vaccinepurchase and accountability records
Goal of this question Make sure the site understands they are required to keep all MnVFC screening documentation for at least three years either electronically or on paper This information should be available to you at the time of the visit and future visits
Resource bull Section 7 of the MnVFC Policies and Procedures Manual
Page 26 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 34
3 Documentation Borrowing Documentation
Question 34 Discuss borrowing practices with the provider to answer the questions below
Note to Reviewer bull To be considered ldquofully documentedrdquo documentation for each borrowed dose must include thefollowing information
Vaccine type borrowed Date the dose was administered Stock used (VFC or private) Reason appropriate vaccine stock was not used Patient name and date of birth Date dose was returned to appropriate stock
A Did the provider state that they had borrowed any vaccines (whetherdocumented or not) since the last VFC Compliance Site Visit
Yes No (If no skip to question 36)
B Are there any doses for which there is no documentation (ie provider hasindicated that doses were borrowed but cannot verify how many or why)
All doses are documented Some doses are not documented [X] No doses are documented [X] (if nodoses documented skip toquestion 36)
C Were all borrowed doses fully documented (See Note to Reviewer above) Yes No [X]
D Were all borrowed VFC doses either replaced or an order submitted to replacethe doses Yes No [X]
Review CDC Requirement
VFC providers are expected to maintain an adequate inventory of vaccine for VFC and non-VFC-eligible patients It is theresponsibility of the VFC provider to appropriately schedule and place vaccine orders VFC providers must also rotate stock to ensure timely use of short-dated vaccines Borrowing of vaccine between private and public inventories must be a rare unplanned occurrence and cannot serve as a replacement system for a VFC providerrsquos privately purchased vaccine inventory All instances ofborrowing must be properly documented reported and replaced
Goal of this question Assess vaccine accountability by verifying that children are receiving vaccine from the appropriate stock
Borrowing is when a fully insured child receives a dose of MnVFC vaccine or a MnVFC-eligible child receives a dose of private vaccine This should be a rare unplanned occurrence The site must document any borrowing of vaccine between stocks ideally on the VFC Borrowing Report Form If they are not currently using the form review it with them and encourage them to post it close to their vaccines It does not need to be sent to MDH but should be kept for 3 years and filed with their MnVFC documents to be reviewed whenever they have a regular or unscheduled (unannounced) site visit
Helpful information bull Understand and report on staffrsquos verbal (ie anecdotal) accounts of borrowing obtained during the visit Often sites do not know that what they do is considered borrowing or they think borrowing is acceptable and documentation isnrsquot needed so long as those vaccines are eventually replaced
bull Since sites using the replacement method only have one stock of vaccine they very rarely borrow bull This question asks for future follow-up in 6 months Make a note on your calendar and ask them to send you a copy of their borrowing reports for the previous 6 months with documentation of doses borrowed and replaced We will remind you if we donrsquot hear from you at the 6 month time frame Complete the Follow-up Form and attach the borrowing form
Resources bull Vaccine Borrowing Report on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfc formshtml)
bull Section 10 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 27
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 353 Documentation Borrowing Reasons
Question 35 Based on your discussion with the provider and a review of borrowing reports document the dosesborrowed for each reason and answer the questions below
Note to Reviewer bull Short-dated vaccines are doses that are likely to expire before they can be used bull Exchanging short-dated vaccines should only occur in practices that have a small number of private
patients
A Reasons for Borrowing a VFC Dose (Enter the number of _____ Private vaccine shipment delay (order placed on time but delay in shippingreceipt)
vaccine doses borrowed for each
reason in the spaces
_____ Private vaccine not useable on arrival (vials broken temperature monitor out of range) _____ Ran out of private vaccine between orders (provider orders not placed on time) [X]
provided) _____ Short-dated private dose was exchanged with VFC stock _____ Accidental use of VFC dose for a private patient (human error) _____ Replacement of private dose with VFC when insurance plan did not cover vaccine _____ OtherDocumented dose did not include reason for borrowing [X]
(Explanation Required) Reasons for Borrowing a Private Dose _____ VFC vaccine shipment delay (order placed on time but delay in shippingreceipt) _____ VFC vaccine not useable on arrival (vials broken temperature monitor out of range) _____ Ran out of VFC stock between orders (provider orders not placed on time) [X] _____ Short-dated VFC vaccine dose was exchanged with private dose _____ Accidental use of a private dose for a VFC-eligible patient (human error) _____ OtherDocumented dose did not include reason for borrowing [X]
(Explanation Required)
B Enter date range for instances of borrowing reviewed in the borrowing report Note If ldquoDate of earliest instancerdquo is not available use the date of the last VFC Compliance Visit If ldquoDate of last instancerdquo is not available use the date of thecurrent VFC Compliance Visit
Date of earliest instance
Date of last instance
C Does borrowing appear to be a routine practice Note To determine whether borrowing is a routine practice assess frequency of and repeating reasons for borrowing Examples Frequent accidental use of incorrect stock exchanging short-dated vaccines or issues with ordering and shipment
Yes [X] No
Goal of this question Determine the reasons why the site is borrowing vaccine
If sites are using the Vaccine Borrowing Report review the reasons for borrowing to help document borrowed VFC andor private doses If they have not been documenting borrowing on this report (or any other form) estimate their borrowing practices If you do not know the date range for their borrowing use the last site visit date to the current visit date The use of ldquootherrdquo as the reported reason for borrowing should be rare if ever and would require explanation and follow up
Helpful information bull Look to see if they routinely maintain insufficient amounts or types of vaccine to support their public and private patients that leads to borrowing
bull Pay attention to borrowing cases documented as ldquoaccidentalrdquo Repetitive accidental borrowing may indicate an issue with ordering processes or insufficient staff training
bull Borrowing is not a place to document wasted or lost doses bull The time period of the borrowing may give you clues about the root cause Were the borrowed doses concentrated in a short period or spread out across several months or a year Are all vaccine types being borrowed or just one
bull If borrowing seems to be an issue discuss vaccine management ordering procedures
Resources bull Vaccine Borrowing Report on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfc formshtml)
bull Section 10 in the MnVFC Policies and Procedures Manual
Page 28 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 36
3 Documentation Vaccine Management Plan
Question 36 Physically review the providerrsquos Vaccine Management Plan to answer the question below
A Does the provider have a Vaccine Management Plan Yes No [X] (If no skip to question 37)
B Does the plan list the current Immunization Manager Vaccine Coordinator andback-up
Yes No [X]
C Does the plan address proper vaccine storage and handling practices Yes No [X]
D Does the plan specify vaccine receiving procedures Yes No [X]
E Does the plan contain procedures for what to do with vaccine in the event of an emergency
Yes No [X]
F Does the plan contain procedures for vaccine ordering Yes No [X]
G Does the plan address inventory control (example stock rotation) Yes No [X]
H Does the plan address how to handle vaccine wastage Yes No [X]
I Does the plan address staff training and documentation on vaccine managementstorage amp handling
Yes No [X]
J Does the plan contain a review date that falls within the last 12 months Yes No [X]
K Has the plan been signed by the individual responsible for its content Yes No [X]
Review CDC Requirement
VFC providers must develop maintain and implement a Vaccine Management Plan for routine and emergency vaccinemanagement The plan must contain the current Vaccine Coordinator and back-up proper storage and handling practicesshipping and receiving procedures emergency procedures procedures for vaccine ordering inventory control (eg stock rotation)how to handle vaccine wastage and staff trainingdocumentation on vaccine management storage and handling The plan must bereviewedupdated annually or more frequently if changes occur A ldquoreview daterdquo and signature are required on all plans in order tovalidate that they are current
Goal of this question Evaluate the sitersquos plan for vaccine management It is especially important that they have a plan for emergency management of their vaccine in the case of equipment failure or power outage Encourage all sites to read and sign the MnVFC Policies and Procedures Manual and complete the emergency plan or be able to show you a plan of their own
If the provider is not able to physically show you the plan at the time of the visit or if the recorded review date is not within the last 12 months you must mark that this requirement is unmet The Vaccine Management Plan is important in times of emergency and it should be easy to access by any staff member at any time Encourage them to post the plan and put a copy with the packing supplies
Helpful information bull Encourage the site to fill in the ldquoImmunization Managerrdquo and ldquoVaccine Coordinatorrdquo fields in the
MnVFC Policies and Procedures Manual for their own referencebull The emergency plan in the manual can be reviewed from last year and included in this yearrsquos manual (with an updated signature and date) if there have not been any changes
bull If information in the plan is outdated site staff will not be well equipped to safely manage vaccines in the event of a power-outage or other emergency situation
bull If their institutional policy is only reviewed and updated every 3-4 years (as many are) the staff may need to sign the MnVFC Polices and Procedure Manual to meet this requirement
Resource Routine Vaccine Management Plan and Emergency Vaccine Management Plan in the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 29
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 37
3 Documentation VIS amp VAERS
Question 37 Review the providerrsquos Vaccine Information Statements (VISs) and discuss providerrsquos VAERS process toanswer the questions below
A Does the provider have readily available up-to-date VISs for all ACIP-recommendedvaccines relevant to the populations it serves
Yes No [X]
B Does the provider make a VIS available for patientsparents before eachvaccination
Yes No [X]
C Does the provider know how and when to report clinically significant adverseevents using VAERS
Yes No [X]
Review CDC Requirement
VFC providers are required to distribute the current Vaccine Information Statements (VIS) each time a vaccine is administered and maintain records in accordance with the National Childhood Vaccine Injury Act (NCVIA) which includes reporting clinicallysignificant adverse events to the Vaccine Adverse Event Reporting System (VAERS) For a list of current VISs visit CDCrsquos Vaccine Information Statements (httpwwwcdcgovvaccineshcpvis) website
Gal of this question Ensure the site has the most current VISs and is giving them to each patientparent before administering the vaccine in compliance with the federal law Parents must be educated about the vaccine their child will receive and be aware of possible contraindications and side-effects in order to make well-informed decisions about their childrsquos health
Helpful information bull Ask to see the sitersquos VISs to determine if they have an active protocol for giving VISs to parents Review to make sure they are current Ask if they know where and how to report vaccine adverse events
Resources bull Section 3 in the MnVFC Policies and Procedures Manual bull CDC Vaccine Information Statements (wwwcdcgovvaccineshcpvisindexhtml) Site may sign up for email updates for the current list of VIS publication dates for the most up-to-date version
bull IAC Itrsquos Federal Law You must give your patients current Vaccine Information Statements (wwwimmunizeorgcatgdp2027pdf)
bull VAERS (httpsvaershhsgovindex)
Question 38
3 Documentation Anaphylaxis protocol
Question 38 Does the site have an anaphylaxis protocol which is clearly posted near the emergency kit
Answers (Choose one)
Yes No [X]
Review CDC Requirement
An anaphylaxis protocol must be clearly posted in the area where vaccines are administered
Goal of this question Make sure site is prepared for a severe allergic or anaphylactic reaction to a vaccine
Resources bull Section 11 in the MnVFC Policies and Procedures Manual bull IAC protocols Child and Teens (wwwimmunizeorgcatgdp3082apdf) and Adults (wwwimmunize orgcatgdp3082pdf)
Page 30 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
i
i i i - li i i i i i l
Section 4 Storage amp Handling Per Unit The goal of this section is to assess vaccine storage
2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet practices in each unit at the site MnVFC PIN ___________________
The 2017 MnVFC Storage amp Handling Per Unit Answer Sheet is a worksheet to document the answers to the questions in this section for each unit (combination or stand-alone) Fill in the answers to the questions in Section 4 on the answer sheet not in the questionnaire
The answer sheet has an abbreviated form of each question If you need further information on that question refer back to the full questionnaire Also if you find an area where the site is not meeting the requirements you will need to go back to that question on the 2017 MnVFC Site Visit Questionnaire to complete ldquoActions if Non- compliantrdquo section including the root cause analysis and follow-up sections If there is a problem in more than one unit make a note on the questionnaire which unit you are referring to in the Notes section
Important You must fully assess any unit that may be used to store VFC vaccines even if there are no VFC vaccines there on the day of the visit If there are no vaccines and the site is not documenting twice a day temperatures discuss the need to ensure the unit is maintaining stable temperatures by monitoring for one week before placing vaccines in the unit
Quest on number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
for the freezer and e co umn
Temperature Monitoring Dev refr gerator f the un
ce Quest ons Quest ons 4 3 4 7 must be answered separate y t s a combo Be sure to document responses n the appropr at
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
44D Data downloaded and reviewed routinely (eg weekly)
Yes No [O]
Yes No [O]
45A Certificate of Calibration Testing Yes No [X]
Yes No [X]
45B Date of calibration
45C Date certificate expires [X] Follow-up is required if expired [X] Follow-up is required if expired
45D Certificate contains all necessary items
Yes No [X]
Yes No [X]
46 Probe properly placed Yes No [X]
Yes No [X]
47A Two temperature readings per day
Yes No [X]
Yes No [X]
47B Time date and name (or initials) for each reading
Yes No [X]
Yes No [X]
47C Current temperature and minmax temperatures (if
Current ________deg Minimum ________deg Maximum _deg
Current ________deg Minimum ________deg Maximum _deg
Sections 5 and 6 contain questions about storage and handling site wide and inventory It is helpful to keep those questions in mind as you assess the individual storage units Think about dorm-style units expired vaccine vaccine supply room for vaccine stocking all the recommended vaccines and separation of stock if appropriate
NOTE The sections that follow require reviewers to validate responses by looking at vaccine storage units temperaturemonitoring equipment and the vaccine inventory inside a unit bull For section 4 use a separate Storage amp Handling Per Unit Answer Sheet for each unit to document the findings (combination
units using both sections can be documented on the same answer sheet) bull When an unmet requirement is identified return to this questionnaire to complete the ldquoActions if Non-compliantrdquo section for
that question bull After you complete one answer sheet for each unit return to the questionnaire to complete sections 5 and 6 using information
you gathered while assessing the units The questions in sections 5 and 6 (Storage amp Handling Site-Wide and Inventory) are notunit-specific but do require that the response be based on a thorough assessment of all the providersrsquo units
4 Storage amp Handling Per Unit
Description On the Storage amp Handling Per Unit Answer Sheet place a name that will allow you or someone else from your program to easily identify this unit in the event of follow-up We recommend using Brand + Location(example Samsung - Room 123) Save each Storage amp Handling Per Unit Answer Sheet with the Brand + Location in the file name
(example SamsungRoom123doc)
IPI Advisor Manual | February 2017 Page 31
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 41
4 Storage amp Handling Per Unit Storage Unit Build amp Use
Question 41 Below select the build and use of the vaccine storage unit you are assessing
Note to Reviewer Dorm-style units Do not add dorm-style units here Dorm-style units will be addressed in section 5 Units storing only private stock You must review these storage units even if they contain only private stockat the time of the visit because that vaccine could be administered to VFC patients
A What type of unit is this A Stand-alone B Combination
B Select use if stand-alone A Freezer B Refrigerator
Select use if combination A Use both sections to store vaccine B Use freezer section only to store vaccine C Use refrigerator section only to store vaccine
Goal of this question Identify the unit you are evaluating The description asks you to create a unique name for this unit so that you will be able to identify the same unit in future site visits Put this description on the top of the answer sheet (ie make and location)
Helpful information bull A stand-alone unit is either a refrigerator or a freezer It does not have both sections in the unit bull If there is a combination unit note if the site uses both the refrigerator and freezer or only one section of the unit to store vaccines CDC does not recommend the use of either section or the freezer section only of combination household units
bull If your site utilizes the separate stock method of vaccine management you must review storage units even if they contain only private stock at the time of the visit because there is a chance that those vaccines could be administered (borrowed) to VFC-eligible patients
Page 32 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 424 Storage amp Handling Per Unit CDC Recommended Storage Units
Question 42 Below document the grade of the vaccine storage unit you are assessing
Note to Reviewer Pharmaceutical Also called ldquopurpose-builtrdquo these units are designed by the manufacturer specifically tostore vaccines or other biological materials Commercial Although usually intended to store food and beverages commercial units are often larger and more powerful than the household units found in most homes Though these units are intended to meet thehigher demands of larger facilities these units are not specifically built for the storage of biologicalmaterials Household (non-commercialdomestic) These units are usually smaller than commercial units and areintended for use in small offices and in homes ndash typically for food storage However just like commercialunits they are not designed specifically for the storage of biological materials Such units are usually available in common home supply stores
Answers (Choose one)
Select grade A Pharmaceutical B CommercialHousehold
[O] CDC does not recommend the use of both sections or the freezer section only of combination commercialhousehold units
Review CDC Recommendation
CDC recommends the following vaccine storage unit types (in order of preference) pharmaceutical grade stand-alone orcombination units (preferred) householdcommercial stand-alone units householdcommercial combination units using therefrigerator section only
Goal of this question Assess the grade and type of each storage unit bull Pharmaceutical grade units may be stand-alone or combination units that are often metal may have glass in the door for viewing inside often have an external digital temperature display and are manufactured by medical companies
bull Commercial or household units often look like your kitchen appliance have vegetablemeat drawers in the unit and are manufactured by household appliance companies
bull Occasionally you might find a medical grade unit which is usually a commercialhousehold unit with a lock and 3-prong plug These are still considered household units because of their ability to maintain proper temperatures and air flow Studies show that household stand-alone units are better able to maintain consistent temperatures than their combination counterparts Combination household units used to store vaccine in both sections of the unit is no longer recommended and may be prohibited in the future Combination household storage units that are having difficulty maintaining a cold enough freezer temperature and a warm enough refrigerator temperature should be replaced or a separate stand-alone freezer should be purchased
For frozen vaccines the most cost effective solution is for the site to purchase a small stand-alone freezer The site may need time to budget for a stand-alone storage unit
Resources bull Replacing Combination Household Units Tip Sheet on IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml)
IPI Advisor Manual | February 2017 Page 33
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 434 Storage amp Handling Per Unit Temperature Monitoring Device in the Unit
Question 43 Determine whether there is a temperature monitoring device in this section of the storage unit andanswer the questions
A Is there a temperature monitoring device in this section of thestorage unit
Yes No [X] (If no skip to question 47)
B Who is responsible for supplying the temperature monitoring device in this section of the storage unit Provider
Review CDC Requirement
Certificates of calibration testing provide confidence that the temperature monitoring device is measuring temperaturesaccurately All units storing VFC vaccines must have a calibrated temperature monitoring device with a current and valid certificateof calibration testing All certificates must contain modeldevice name or number serial number date of calibration testing (report or issue date) and Instrument Passed testingInstrument in Tolerance (Recommended uncertainty = +-05ordm C (+-1ordm F))
Goal of this question Assess whether there is a temperature monitoring device in the unit If the unit is not being monitored at all call MDH at 651-201-5522 for guidance
Helpful information bull This question does not ask whether the temperature monitoring device is working or the characteristics of the device These issues will be addressed later in the questionnaire
bull For part B the provider is always responsible for supplying the temperature monitoring device Even if their thermometer or data logger was originally from MDH it is their responsibility to ensure it is functional and calibrated
Resources bull Section 8 in the MnVFC Policies and Procedures Manual
Page 34 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 444 Storage amp Handling Per Unit CDC Recommended Temperature Monitoring Device
Question 44 Assess the temperature monitoring device in this section of the storage unit to answer the questionsbelow
A Is the temperature monitoring device a continuous monitoring and recordingdevice (eg data logger)
Yes No [O] (Skip D)
B Does the temperature monitoring device have a probe in buffered material Yes No [O]
C Does the temperature monitoring device have a digital display that can beeasily read from the outside of this unit
Yes No [O]
D Is data downloaded and reviewed routinely Yes No [O]
Review CDC Recommendation
As of Jan 1 2018 all VFC providers must use continuous temperature monitoring devices (eg data loggers) to monitor vaccinesthat will be administered to VFC-eligible children Routine review and accessibility of temperature data is critical for determining whether vaccine has been properly stored and for assessing usability of vaccine that was involved in a temperature excursion Tomeet VFC Program requirements the device must also be equipped with bull A temperature probe bull An active temperature display that can be easily read from the outside of the unit bull The capacity for continuous monitoring and recording capabilities where the data can be routinely downloaded
The following are additional recommended features for these devices bull Alarm for out-of-range temperatures bull Current minimum and maximum temperatures display bull Low battery indicator bull Accuracy of +- 1degF (05degC) bull Memory storage of at least 4000 readings bull User programmable logging interval (or reading rate) recommended at a maximum time interval of every 30 minutes bull Use of a probe that best reflects the temperature of the vaccine (such as a buffered probe)
Goal of this question Assess the temperature monitoring device in the storage unit Note that these are all recommendations not requirements at this time
This is a great teaching opportunity for sites who do not currently have a continuous temperature monitoring device Beginning Jan 1 2018 all units that store MnVFC vaccine will be required to have a continuous temperature monitoring device (ie a data logger or a continuous temperature monitoring system) Unlike a minmax thermometer a continuous temperature monitoring device provides detailed information on all temperatures recorded at pre-set intervals For excursions it can provide information on when a temperature went out-of-range for how long and what the temperatures were This is essential information that vaccine manufacturers need to know to assess the viability of the vaccine following an excursion
Helpful information bull Sites are required to monitor and record temperatures twice daily however temperature excursions can easily occur in the 12 hours or longer between readings Continuous temperature monitoring can help manufacturers determine vaccine viability
bull Continue to encourage sites to document and evaluate minimum and maximum temperatures the storage unit reached since the last reading and respond appropriately to out-of-range temperatures
IPI Advisor Manual | February 2017 Page 35
The 2017 MnVFC Site Visit Paperwork Chapter 4
bull It is recommended that sites download and review data weekly Discuss with sites that reviewing temperature monitoring device data also includes responding appropriately if they identify out-of-range temps
bull There is sometimes confusion about the difference between a data logger and a continuous temperature monitoring system Here are some differences
Data Loggers Continuous Monitoring Systems Have an external display similar to thermometers May or may not have an external display Have a detachable probe Probe is usually attached to transmitter Need to be plugged into the computer or cradle to download information on a regular schedule
Wirelessly sends data to computer system
Create a file of data that needs to be saved on the computer
Data is stored within the system not a separate file
Doesnrsquot allow documentation of twice a day temperature checks in the file
May allow documentation of twice a day temperature checks within the system
More about the 2018 requirement for a continuous temperature monitoring device
Required Features bull The continuous temperature monitoring device must have Continuous monitoring and recording capabilities to track and record temperatures over time The capacity to routinely download temperature data to a computer (recommended at least weekly) or wirelessly transmit data Detachable probe in a bottle filled with a thermal buffer (eg bio-safe glycol) if the data logger needs to be detached in order to download data Active temperature display
Recommended Features bull MnVFC recommends continuous temperature monitoring devices with Alarm for out-of-range temperatures Accuracy within +-1degF (+- 05degC) Low battery indicator Display of current minimum and maximum temperatures Memory storage of at least 4000 readings User programmable logging intervals (eg the user can set how often the device records the temperature)
Note that these are all currently recommendations not requirements yet
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Page 36 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 45
Goal of this question Ensure the temperature monitoring device is properly calibrated The certificate of calibration testing means that the device has been tested and it is accurately measuring temperatures within established testing limits The certificate of calibration ensures that the device meets all the required components
Helpful information bull The provider is always responsible for having a current certificate of calibration (or copy) on-site
bull To be considered ldquovalidrdquo a certificate of calibration must contain these required elements Modeldevice name or number Serial number
4 Storage amp Handling Per Unit Certificate of Calibration Testing
Review CDC Requirement
Certificates of calibration testing provide confidence that the temperature monitoring device is measuring temperaturesaccurately All units storing VFC vaccines must have a calibrated temperature monitoring device with a current and valid certificateof calibration testing All certificates must contain modeldevice name or number serial number date of calibration testing (report or issue date) and Instrument Passed testingInstrument in Tolerance (Recommended uncertainty = +-05ordm C (+-1ordm F))
Question 45
Note to Reviewer
A
B
C
D
E
Review the certificate of calibration testing for the temperature monitoring device in this section of the storage unit and answer the questions below
bull How to determine certificate of calibration testing expiration date 1) Identify the certificate issuecalibration date 2) Apply the Immunization Program-required frequency for calibration testing Example If the
issuecalibration date is 12312013 and Immunization Program policy requires testing every twoyears the expiration date is 12312015
bull Certificates must include all of the below bull ModelDevice Name or Number bull Serial Number bull Date of Calibration Testing (Report or Issue Date) bull Instrument Passed testing (Instrument in Tolerance)
Is there a certificate of calibration testing for the temperature monitoring Yes device in this section of the storage unit No [X]
What is the date of calibration for the temperature monitoring device in this section of the storage unit
What is the certificatersquos date of expiration based on ImmunizationProgram policy (See note to reviewer to determine expiration date) [X] Follow-up is required if
certificate is expired
Does the certificate contain all the necessary items listed in the Note to Yes Reviewer No [X]
Who is responsible for supplying the current and valid certificate of Provider calibration for this temperature monitoring device
Date of calibration testing (report or issue date) Note If there is no expiration date the certificate expires 2 years from the date of calibration Whether the instrument passed or failed testing (or instrument in tolerancenot in tolerance)
bull Recommended element Documented uncertainty of +- 1degF [05degC]
If these elements are present the certificate is considered valid If the certificate contains information about the recommended element or the entity that issued the certificate that is helpful but not required
To determine if a certificate of calibration testing was issued by an appropriate entity check to see if the certificate indicates one or more of these items (this is the wording used to help sites evaluate if their calibration is accurate but is not required on the certificate itself to be considered valid)
bull Conforms to ISO 17025 bull Performed by an ILACMRA Signatory body accredited laboratory You can review this list of the ILAC MRA and Signatories (httpilacorgilac-mra-and-signatories)
bull Traceable to the standards maintained by NIST bull Meets specifications and testing requirements for the American Society for Testing and Materials (ASTM) Standard E2877 tolerance Class F (le 05 degC) or better
bull Includes reference to another acceptable accuracy validation method such as comparison to other traceable reference standards or tests at thermometric fixed points
Note CDC recommends that certifications be issued for the entire monitoring unit (detachable probe data logger etc) and not individual certificates for each component
IPI Advisor Manual | February 2017 Page 37
The 2017 MnVFC Site Visit Paperwork Chapter 4
For 45 E the provider is always responsible for supplying the current and valid certificate of calibration for a temperature monitoring device
bull Tip If the temperature monitoring device has a sticker on the back with the calibration date the site can usually call the company who calibrated the device and get a copy of the certificate if they donrsquot have one
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 46 4 Storage amp Handling Per Unit Probe Placement
Question 46 Is the probe properly placed in this section of the storage unit
Note to Reviewer ldquoProperlyrdquo means that the probe in a commercial or household unit is placed in a central area of the unitdirectly with the vaccines Probes should not be placed in the doors near or against the walls close to vents or on the floor of the unit The only allowable exemption related to this requirement is for providerswho have pharmaceutical storage units (built for vaccine storage) that have either (1) a built-intemperature monitoring device OR (2) a dedicated port for the probe that dictates the placement of theprobe
Answers (Choose one)
Yes No [X]
Review CDC Requirement
The probe must be placed in a central area of the section of the storage unit directly with the vaccines in order to properly measurevaccine temperature The probe should not be placed in the door near or against the walls close to vents or on the floor of theunit For pharmaceutical units with a built-in temperature monitoring device or a dedicated port for a probe that is not in thecenter of the section of the storage unit consult your Immunization Program for guidance on placement
Goal of this question Make sure the temperature monitoring device is in the best location to accurately measure the temperature of the vaccines stored in the unit
Helpful information bull The probe of the temperature monitoring device should be placed directly with the vaccines in the middle of the unit The ONLY allowable exception is for pharmaceutical storage units that have either a built-in thermometer or a dedicated port for the probe that indicates placement of the probe
bull Temperatures can vary within the unit especially household units bull Call MDH at 651-201-5522 if you have questions
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Guide (wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml)
Page 38 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 474 Storage amp Handling Per Unit Temperature Documentation
Question 47 Review the temperature documentation over the past three months for this section of the storage unit todetermine whether the provider has a process in place for properly documenting temperatures twice aday Answer the questions below
A Are there two temperature readings recorded for this section of the storage unit per day
Yes No [X]
B Is there a time date and name (or initials) recorded for each reading Yes No [X]
C What is the current temperature and minmax temperatures (if available) inthis section of the storage unit Use the reviewerrsquos thermometer if the providerrsquos temperature monitoringdevice does not have a current valid certificate of calibration testing or the probe is not properly placed in this section of the storage unit
Current Temperature Minimum Temperature Maximum Temperature Fahrenheit Celsius
D Based on your review of the providerrsquos recent temperature documentationincluding the current temperature is this section of the storage unitmaintaining appropriate temperatures
Yes No [X] Not enough information [X]
Review CDC Requirement
Vaccines must be stored under appropriate temperatures as described in the package inserts at all times Acceptable temperature ranges vary by vaccine type and the range is 36deg F and 46deg F (2deg C and 8deg C) and for frozen vaccines the range is -58deg F and +5deg F (shy50deg C and -15deg C) Exposure to temperatures outside of those included in the package inserts could affect vaccine viability andultimately could leave children unprotected against vaccine-preventable diseases In order to maintain awareness of storage unittemperatures and ensure that vaccines are being stored at appropriate temperatures at all times VFC providers are required to monitor and document temperatures for all vaccine storage units at least twice a day Temperature documentation must contain (1) at least two temperature readings per day (2) the time and date of each reading and (3) the name (or initials) of the personwho assessed and recorded the readings CDC also recommends that VFC providers record the minimum and maximumtemperatures of each unit once each workday (preferably in the morning)
Goal of this question Ensure the temperature is being monitored twice daily is within the required range and documented correctly Use your thermometer to check the temperature if the sitersquos temperature monitoring devicersquos probe is not properly placed or there is not a current certificate of calibration Place your thermometer in the unit at the beginning of the visit to allow sufficient time to reach an accurate temperature The purpose of using your thermometer is to ensure the vaccine is being stored at the proper temperature not to ldquovalidaterdquo their reading
Question 47 D is an assessment question based on information you have learned during your visit You might answer ldquonot enough informationrdquo if the unit is new and they donrsquot have at least three months of data or if the unit is only used as overflow and they are inconsistent with temperature monitoring Mark ldquoNordquo if you have reason to believe the storage unit is not maintaining temperatures properly
Helpful information bull All sites must document temperatures twice a day every day the site is open even if they have a data logger or continuous monitoring system
bull Sites can document the information electronically with some continuous monitoring systems as long as it can show what the current temp is the date time and initials of the person checking ndash this needs to be someone at the site ndash not checking remotely or centrally for a large site or system The site must be able to produce these records during their site visit Reviewing these files can be a challenge due to large volumes and lots of paper
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Temperature Logs on Managing Vaccine (wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml)
IPI Advisor Manual | February 2017 Page 39
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 484 Storage amp Handling Per Unit Temperature Excursions
Question 48 In the event that a temperature excursion(s) occurred in this unit within the last three months requestand review documentation of actions taken to determine whether the provider has a process for properlyaddressing excursions Answer the questions below
A Were vaccines in this unit exposed to out-of-range temperatures in the lastthree months (including today)
Yes No (If no skip to question 49)
B Did the provider quarantine and label vaccines as ldquoDo not userdquo Yes No [X]
C Did the provider place vaccine in a unit where it can be stored under properconditions if applicable
Yes No [X]
D Did the provider contact the Immunization Program to report theexcursion
Yes No [X]
E Was the manufacturer contacted for documentation supporting theusability of the vaccine
Yes No [X]
Review CDC Requirement
The provider must document all excursions and actions taken including the following (1) Quarantine and label vaccines as ldquoDO NOTUSErdquo (2) Place vaccines in a unit where they can be stored under proper conditions (3) Contact the Immunization Program to report an excursion and (4) Contact the vaccine manufacturer to obtain documentation supporting the usability of the vaccine
Goal of this question Address any out-of-range temperatures (temperature excursions) identified in reviewing the last three months of temperature logs or during the site visit If there were any out-of-range temperatures did the site respond appropriately to the situation This is a great opportunity to discuss what to do in the event of an excursion The Clinicians Storage and Handling Mishap Checklist is in the IPI Site Visit information folder and is a good review of the process
Helpful information bull Sites need to know that an excursion does not automatically mean that exposed vaccines are non-viable or unusable Exposed vaccines must be quarantined (marked ldquoDo Not Userdquo) and stored under proper conditions until they have received information from vaccine manufacturers regarding the viability of the vaccine
bull Sites must inform MDH when an excursion occurs
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Clinicians Storage and Handling Mishap Checklist (wwwhealthstatemnusdivsidepcimmunize ipivaxchklstpdf)
Page 40 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 49
Goal of this question Ensure proper placement of vaccines in the storage unit
Note These are all recommendations (best practices) not requirements
Helpful information bull Store vaccine in the middle of the compartment two to three inches away from the coils walls floor and cold air vent The temperature near the floor and walls of the unit differs from that in the middle of the compartment and the cold air vent can freeze refrigerated vaccines
4 Storage amp Handling Per Unit Vaccine Placement
Question 49 Look inside the unit to answer the questions below
A Are vaccines placed in the middle of the unit with space between vaccinesand the sideback of the unit to allow cold air to circulate
Yes No [O]
B Are vaccines stored in their original packages Yes No [O]
C Are there water bottles (for refrigerators) or frozen water bottles (forfreezers) in the unit
Yes No [O]
D Are vaccines store in the doors vegetable bins under or near cooling ventsor on the floor of the unit
Yes [O] No
E Is food being stored in the unit Yes [O] No
Review CDC Recommendation
Vaccines should be stored in their original manufacturer (or CDC centralized distributor) packaging They should be placed in the middle of the unit with space between the vaccines and the sideback of the unit to allow cold air to circulate Vaccines SHOULD NOT be stored in the doors vegetable bins or floor of the unit or under or near cooling vents and there should not be any food inthe unit Water bottles (for refrigerators) or frozen water bottles (for freezers) should be placed throughout each storage unit inorder to (1) stabilize or extend temperatures during a power outage and (2) to serve as physical blocks preventing the placementof vaccines in areas of the unit that are at higher risk for temperature excursions (such as in doors vegetable bins floor ornearunder cooling vents)
bull Vaccines should be kept in their original packaging to Protect them from light Help prevent medication errors by making labels easier to read Provide a moisture barrier that serves as insulation in case of an out-of-range temperature power outage door left open or mechanical failure Simplify managing vaccine inventory
bull Store water bottles in the doors on the floor and near the cold air vent in the refrigerator and frozen water bottles in the freezer to help maintain a stable temperature if there is a power failure and when the door is opened frequently Too many water bottles in the door can prevent the door from closing tightly Mark water bottles ldquoDo Not Drinkrdquo
bull Do not store vaccine in the door or drawers of the refrigerator or freezer Vegetable bins and crisper drawers should be removed from refrigerators or used to store other medical supplies or water bottles
bull If vaccine is stored in a household combination refrigeratorfreezer The top shelf should not be used for storing vaccine because the cold air vent blowing from the freezer will freeze vaccine located there If you must use the top shelf of this type of unit place water bottles underneath the cold air vent to prevent vaccine from being stored there It is recommended that only the refrigerator be used for vaccine storage and a separate stand-alone freezer be used to store frozen vaccine
bull Must not store food or beverages in the refrigerator or freezer because frequent opening of doors can lead to temperature variations that may affect vaccine viability There is also a risk of contaminating vaccines
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Guide (wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml) bull Vaccine Storage Tip Sheet on IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml)
IPI Advisor Manual | February 2017 Page 41
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 4104 Storage amp Handling Per Unit Disconnection from Power Source
Question 410 Ask the provider to demonstrate what measures are taken to ensure that vaccine storage units are notaccidentally physically disconnected from the power supply Which of the following describes the measure(s) taken on this unit
Note to Reviewer bull Large hospitals and healthcare systems may not have the ability to demonstrate labels on plugs or circuitbreakers In such cases verify that the practice has a comprehensive policy and standard operatingprocedures in place to prevent the vaccine storage unit from being physically disconnected from thepower supply
bull While back-up generators may ensure power to the overall facility this question ONLY addresses thevaccine storage unit being accidentally disconnected from the power source either through the plug orthe circuit breaker
Answers A ldquoDo not disconnectrdquo labels on the plug (Choose all that B ldquoWarningrdquo label on the circuit breaker box
apply) C Hard-wired (ie built-in) and has a ldquoDo not disconnectrdquo label on thecircuit breaker box D Hospital or large health care system with a comprehensive written policyand standard operating procedures detailing measures taken to preventvaccine storage units from being accidentally disconnected from the powersupply E No acceptable measures for preventing accidental disconnection frompower supply [X]
[X] The response is non-compliant if only A only B or E is selected
Review CDC Requirement
VFC providers must take steps to protect the power source for all vaccine storage equipment by means of having clear warninglabels on both the plug and the circuit breaker associated with all vaccine storage units Large hospitals and healthcare systems canmeet this requirement by demonstrating that they have comprehensive policies and standard operating procedures to preventvaccine storage units from being physically disconnected from the power supply
Goal of this question Decrease the chance that a vaccine storage unit will be accidently unplugged or power will be turned off while vaccine is in the unit This question addresses only what measures the site has taken to ensure the storage unit is not physically disconnected from its power source
If the site uses labels on the plugs and circuit breakers perform a visual inspection to assess whether the way the stickers are positioned make it clear and obvious to anyone that these units are not to be disconnected
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Do Not Unplug and Warning stickers are included in the folder or available to order on the For
Professionals Order Form (wwwhealthstatemnusdivsidepcimmunizeordermathtml)
Note Once you have completed the 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet for each unit return to the questionnaire to complete sections 5 and 6
Page 42 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
- -
Section 5 Storage amp Handling Site-Wide Question 51
5 Storage amp Handling Site Wide Discussion of Cost amp Quantity of Vaccine
Question 51 Have a discussion with the provider about the cost and quantity of VFC vaccines they are responsible for annually Address the points listed in the note to reviewer below
Note to Reviewer bull Vaccine Shipped (Required) Share the cost of VFC vaccines shipped to the provider in the last calendaryear to make sure the provider understands the contribution made by the VFC Program to their practiceFor new providers who do not have ldquocalendar yearrdquo data share either the actual cost of their currentinventory or use the cost of 10 VFC doses of each of the ACIP-recommended vaccines (approximately $7000) to help estimate their annual cost
bull Storage amp Handling (Required) Make sure the provider understands the cost of vaccines for which they are responsible when they make decisions about purchasing recommended vaccine storage and temperature monitoring equipment
Answer I have discussed with the provider the cost and quantity of vaccines ordered in the previous calendar year
Goal of this question Inform sites of the quantity and value of vaccines that they receive as part of the MnVFC program Providers often donrsquot realize the value of the vaccine in their unit This information is included on your clinic list and on the one page site-specific information
Helpful information bull This discussion must occur and the box on the questionnaire must be checked bull If there isnrsquot actual vaccine value information available tell the site that one vaccine order that includes a box of each of the ACIP recommended vaccines costs approximately $7000
bull MDH may not have specific information for individual sites if they receive vaccine from a central warehouse or pharmacy For those sites MDH will give you numbers for the whole system so you can discuss system wide data as appropriate If individual site information is also included it is usually just varicella-containing vaccines that must be shipped directly to the site
Question 52
5 Storage amp Handling Site Wide Dorm Style Units
Question 52 Determine whether the provider has any dorm-style units on site and answer the questions below
Note to Reviewer A dormitory-style refrigerator is a unit that has both refrigerator and freezer compartments behind a singleexterior door Dorm-style units also have an evaporator plate (cooling coil) which is usually located insidean icemaker compartment (freezer) within the refrigerator
A Does the provider have any dorm-style units that are used at any time tostore vaccines
Yes [X] No (Skip to question 53)
B Does the provider have sufficient space in existing compliant vaccinestorage units to store all vaccines without use of the dorm-style unit at any time
Yes No [X]
Review CDC Requirement
Dorm- and bar-style units are prohibited for vaccine storage Vaccines stored in dorm-style units are considered non-viable and must be returned to the centralized distributor CDC recommends the following vaccine storage unit types (in order of preference)pharmaceutical grade stand-alone or combination units (preferred) householdcommercial stand-alone unitshouseholdcommercial combination units using the refrigerator section only
Goal of this question Ensure no vaccine is stored in dorm-style units even for short periods of time Encourage them to label any units ldquoNo Vaccine Storage Allowedrdquo Vaccine stored in these units is considered non-viable If a site is using a dorm-style unit call the MnVFC program (651-201-5522)
Resource Section 8 in the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 43
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 535 Storage amp Handling Site Wide Storage Unit Space Availability
Question 53 Does the provider have sufficient room across storage units to store current stock as well as anyadditional stock acquired during peak season without overcrowding
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have sufficient storage space to accommodate vaccine stock at the busiest time of year without overcrowding
Goal of this question Ensure that sites have sufficient space in their units to maintain vaccines at the busiest time of year Overcrowding of vaccine limits air circulation and affects the unitrsquos ability to maintain stable temperatures
Helpful information bull Look for signs of overcrowding such as vaccines that are pushed up against the wall bins that are overflowing or storage units that are full during non-peak seasons
Discuss immediate actions if the unit is overcrowded Move some of their vaccines order less vaccine more frequently (once per month preferably) andor purchase another storage unit for overflow
Resource bull Section 8 MnVFC Policy and Procedure Manual
Page 44 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 545 Storage amp Handling Site Wide Expired Vaccines
Question 54 Look in each unit Are there expired vaccines in any of the vaccine storage units at this site
Answers (Choose one)
Yes [X] No
Review CDC Requirement
Vaccines should be rotated weekly and when a new shipment comes in so that longer-dated vaccines are stored behind shorter-dated vaccines If vaccines expire they can no longer be stored in the same storage unit with viable vaccines They must be placedin a container or bag clearly labeled ldquoDo not userdquo and separated from viable vaccines to prevent inadvertent use Expired vaccinemust be returned to the centralized distributor within six months of expiration
Goal of this question Ensure there is no expired vaccine in any storage unit
Helpful information bull Sites can prevent their stock from expiring by rotating vaccines every week andor when a new shipment arrives Longer-dated vaccines are stored towards the back of the unit and shorter-dated vaccines are up front
bull Pay attention to vaccines that expire within the next three months Consider transferring vaccine that will expire soon to another MnVFC-enrolled site that will use the vaccine preferably a site close by It is the transferring sitersquos responsibility to arrange the transfer of the vaccine Be sure to complete the MDH Vaccine Transfer Record form and send it to MDH If they are having difficulty finding a location to accept vaccine contact MDH
bull This is a great opportunity to educate sites about the MDH Nonviable Vaccine Form and the process for returning vaccine The VFC program does get some credit for taxes and fees on vaccine that is returned to the distribution center
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MDH Nonviable Vaccine Form and MDH Vaccine Transfer Record on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfcformshtml)
IPI Advisor Manual | February 2017 Page 45
The 2017 MnVFC Site Visit Paperwork Chapter 4
- -
-
Question 555 Storage amp Handling Site Wide Back up Thermometer
Question 55 Does the provider have a readily available back-up thermometer with a current and valid certificate ofcalibration testing
Note to Reviewer ldquoReadily availablerdquo means that the thermometer is available to perform twice-a-day monitoring for a unit asrequired CDC recommends that the back-up thermometer be maintained on site
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have a readily available back-up thermometer with a current and valid certificate of calibration testing Toprevent the certificates of calibration testing of the primary and back-up thermometers from expiring at the same time the date of calibration testing (or issue date) of the back-up thermometer should be different from the date of calibration testing (or issue date) of the primary thermometer As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meetsVFC program requirements
Goal of this question Ensure sites have one calibrated back-up thermometer onsite that is readily available in the event that the temperature monitoring device in unit fails transportation of vaccine is needed or there are other unexpected circumstances
Helpful information bull As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meets VFC Program requirements
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 56 5 Storage amp Handling Site Wide Preparation of Vaccine
Question 56 When does this provider prepare vaccine for administration to the patient
Note to Reviewer For mass vaccination clinics if one type of vaccine is offered providers may pre-draw up to 10 doses Ifusing pre-filled syringes pre-drawing also means activating the syringe by removing the needle guard orattaching a needle
Answers (Choose all that
apply)
Prepare dose immediately before administration Pre-draw doses for upcoming patients (in a regular clinicpractice) [O] Pre-draw up to 10 doses (in a mass-vaccination clinic) Pre-draw more than 10 doses (in a mass-vaccination clinic) [O] Other [O]
Review CDC Recommendation
CDC recommends preparing vaccines immediately prior to administration in order to assure viability of vaccine and prevent vaccinewastage Vaccines that are not administered immediately are at risk of exposure to temperatures outside of the required rangewhich can affect vaccine viability and ultimately can leave children unprotected against vaccine-preventable diseases
Goal of this question Discuss proper timing and preparation of vaccine(s) for administration These are recommendations not requirements
Helpful information bull Educate staff on the importance of preparing vaccine immediately before administration Pre-drawing of vaccines may lead to concerns related to vaccine viability potency sterility and wastage
Page 46 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 6 Inventory Question 61
6 Inventory Inventory Comparison
Question 61 Visually inspect storage units to determine if existing supply of vaccines proportionately mirrorspopulations served Choose the most accurate statement below
Note to Reviewer bull CDC recommends that providers maintain a four-week supply of inventory bull For this question do not take into account vaccine types that the provider does not order Here simply
make sure that overall the vaccines in the providerrsquos storage units are available in sufficient amounts toserve their patient population
Answers (Choose one)
The current vaccine inventory proportionately reflects the populations identified Only public stock is insufficient [X] Only private stock is insufficient [X] Both public and private stock are insufficient [X] Site uses the replacement method but does not appear to have enough vaccine for their population [X] Other [X]
Review CDC Requirement
VFC providers must order and stock routine vaccines in accordance with their patient population in order to prevent missedvaccination opportunities Having sufficient amounts of all stocks prevents the inadvertent use of VFC vaccines for non-VFC-eligiblepatients and vice versa
Goal of this question Assess whether the site is ordering appropriate quantities of vaccine for the population they serve at their site
Helpful information bull If the site sees 30 percent private-pay patients and 70 percent VFC the stock in their storage units should reflect that proportion If you donrsquot know you can ask the site about their population
bull This is meant to be a general assessment so in a big site if they have only a small amount of vaccine that may indicate an issue with vaccine management
bull CDC recommends smaller more frequent orders (ie monthly) rather than large orders to minimize the amount of vaccine loss if an incident occurs during shipment or in the storage unit Sites should not order more frequently than once a month
bull Sites using the replacement method will only have one stock but it should appear to be large enough for their population
bull Only assess the vaccine types that the site currently stocks in their unit We know there are sites that do not offer all ACIP-recommended vaccines for various reasons That issue will be addressed in question 62
IPI Advisor Manual | February 2017 Page 47
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 626 Inventory ACIP Recommended Vaccines
Question 62 Review providerrsquos current inventory to answer the questions below
A Does the provider offer all routine ACIP-recommendedvaccines for their patient population
Yes (Skip to question C) No [X] Offers all except varicella because direct ship ofvaccine is unavailable from manufacturer
B Which routine vaccines are NOT being offered DTaP Hepatitis A Hepatitis B HIB HPV Influenza Meningococcal
MMR Pneumococcal Polio Rotavirus TdapTd Varicella
C According to Immunization Program Policy does theprovider make accessible all non-routine ACIP-recommended vaccines for those VFC patients whomeet the criteria for receiving them
Yes (Skip to question 63) No [X]
D Which non-routine vaccines are NOT being offered Pneumococcal polysaccharide vaccine (PPSV23) Meningococcal Group B (MenB) Other
Review CDC Requirement
VFC providers agree to comply with immunization schedules dosages and contraindications that are established by the Advisory Committee on Immunization Practices (ACIP) for the vaccines identified and agreed upon in the Provider Agreement UNLESS bull In the VFC providers medical judgment and in accordance with accepted medical practice the VFC provider deems such
compliance to be medically inappropriate for the child bull The particular requirements contradict state law including laws pertaining to religious and other exemptions The VFC program entitles children to the following vaccines DTaP Hepatitis A Hepatitis B HIB HPV Influenza MeningococcalMMR Pneumococcal Polio Rotavirus TdapTd and Varicella VFC providers are also required to ensure that VFC-eligible children have access to non-routine vaccines as needed
Goal of this question Assess if the site is offering all the ACIP-recommended vaccines for the population they serve and these vaccines are in stock on the day of the visit It is important that every MnVFC-eligible child that comes to a providerrsquos office for an immunization is vaccinated
Helpful information bull The Advisory Committee on Immunization Practices (ACIP) is a group of medical and public health experts that develops recommendations on how to use vaccines to control diseases in the United States
bull Specialty providers are not required to offer all routine vaccines but should provide the vaccines appropriate for their population
bull If the site does not offer all routine ACIP-recommended vaccines appropriate for their population check the ldquoNordquo box in Part A then check the appropriate box(es) in Part B for any vaccines not offered Please contact MDH as this situation offers us the opportunity to provide education to the site
bull For non-routine vaccines they must either be in stock or the site must have an alternative protocol in the routine management plan that ensures these children have access when applicable
Resources bull IAC Diseases and Vaccines (wwwimmunizeorgvaccines) bull CDC Advisory Committee on Immunization Practices (ACIP) (wwwcdcgovvaccinesacipindexhtml)
Page 48 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 636 Inventory Separation of Stock
Question 63 Observe how the provider differentiates stock in each storage unit to answer the questions below
A Is it clear which vaccines belong to public stock andwhich belong to private stock
Yes No [X] Not applicable replacement site
B Is it clear which vaccines belong to VFC stock andwhich belong to UUAV stock
Yes No [X] Not applicable replacement site Not applicable not UUAV-enrolled site
Review CDC Requirement
In order to ensure that VFC vaccines are only administered to VFC-eligible children VFC providers that serve both VFC and non-VFCshyeligible children must maintain their vaccine inventories in such a way that they can clearly differentiate public stock from privatestock as well as VFC from other public stock
Goal of this question Assess whether the site can distinguish between MnVFC vaccine and private vaccine If they participate in the Uninsured and Underinsured Adult Vaccine (UUAV) program they should also be able to distinguish between MnVFC stock and UUAV stock Some sites use labels bins boxes etc to differentiate their stock If it is not clear how the site differentiates their stock discuss vaccine management with the staff For follow-up call MDH to discuss doing a follow-up site visit
Sites using the replacement method will not have separate stocksmdashthis is an approved alternative method for keeping track of vaccine
Resource bull Section 10 of the MnVFC Policy and Procedure Manual
IPI Advisor Manual | February 2017 Page 49
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
MnVFC Site Visit Storage and Handling Per Unit Answer Sheet 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet MnVFC PIN ___________________
Question number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
Temperature Monitoring Device Questions Questions 43 47 must be answered separately for the freezer and refrigerator if the unit is a combo Be sure to document responses in the appropriate column
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
All the questions on the Site Visit Storage amp Handling Per Unit Answer Sheet have been discussed previously in section 4 of this manual Use this sheet to record information about all the units at the site visit You will need one sheet for each unit If it is a combination unit (either pharmaceutical or household) you can record both sections on one sheet If they have stand-alone units use one sheet for each unit Do not enter the answers to the questions in section 4 of the questionnaire
If you need more information about any of the questions refer back to the main questionnairemdashthe complete question additional guidance including notes to the reviewer and the CDC requirements are there Also if the site is not meeting the requirement you will go back to the questionnaire to complete the ldquoActions if Non-compliantrdquo section including the root cause analysis and follow-up sections
When you have completed the assessment of all the storage units remember to go back to the questionnaire to complete sections 5 and 6
Page 50 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
ndash
ndash
MnVFC Provider Follow-up PlanThe goal of the Provider Follow-up Plan is to communicate with the site all of the VFC requirements any unmet requirements found during your site visit and the timeline for completing the required action The left hand column is a box to check for ldquoUnmetrdquo requirements
Helpful information bull The form can be used to review what the site is doing well and what they need to work on
bull For requirements that have specific documentation that needs to be sent to you use the notes section
2017 MnVFC Provider Follow-up Plan Site _______________________________________________ MnVFC PIN ____________ Date of Visit ___________
Thank you for participating in this MnVFC compliance site visit Please review this visit summary including follow-up actions and timelines for completion Unmet MnVFC requirements and recommendations have a checked box next to them The goal of this plan is to support you with successfully implementing the program and improving access to vaccines for VFC-eligible children
Unmet Question VFC Requirements Section 1 Changes to Key Staff
Q12 Change in the Medical Director Immunization Manager Vaccine Coordinator or back-upKey Staff must be communicated to the immunization program by emailing healthmnvfcstatemnus Changes Notes
Q12 Key staff must complete the annual training on VFC program requirements and print theAnnual Training certificate of completion Documentation Required Action
Staff that have not completed the MnVFC online training must complete it and send acopy of the certificate to the reviewer Training can be found on the MnVFC website (wwwhealthstatemnusvfc) Due date 1 month
Notes
Unmet Question VFC Requirements Section 2 Eligibility
Q21 Provider staff must possess a working knowledge of all VFC eligibility criteria and use thoseVFC Eligibility criteria to screen children prior to administering VFC vaccines
Categories Notes
bull This form provides documentation needed for follow-up actions when you send your thank you email
The second to last page of the Provider Follow-up Plan has a summary of the MnVFC program recommendations These are to remind the site about best practices they may want to improve upon even though they are not yet requirements of the program For example you could discuss the recommendation about storage units if they currently have a combination household unit and are using both sections
The last section is for your signature and the person you met with In most sites it will be the immunization manager or vaccine coordinator who signs the form unless the medical director attended the site visit You keep the original copy and the site will need to keep a copy for themselves
To be completed by the site visit reviewer
I acknowledge that a VFC site visit was performed on __________________ (visit date) The follow-up plan which includes a list of all current VFC program requirements and recommendations assessed during the visit and any required follow-up actions was provided at the end of the visit
Site visit reviewer
Phone
Reviewer Signature Date
To be completed by the provider
I acknowledge that our practice took part in the VFC site visit noted above I understand the findings of the visit and any required actions that must be taken by our office in order to meet VFC program requirements
Medical Director (or designee) Name Title
Medical Director (or designee) Signature Date
IPI Advisor Manual | February 2017 Page 51
The 2017 MnVFC Site Visit Paperwork Chapter 4
After the Site Visit Send a thank you email highlighting the unmet requirements documents you need from the site to resolve the issue(s) and the date you need them Make sure to include the link to the Site Visit Survey (httpssurveyvovicicomseashxs=56206EE334CE0B14)
Please refer to Chapter 3 for more information about future follow-up required after the visit including forms and documentation
Resource bull Sample Thank You letter on IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml)
Chapter 5
IPI Advisor Resource List MnVFC Program 651-201-5522
MnVFC wwwhealthstatemnusvfc
bull Separate Stock and Replacement Method Policies and Procedures Manuals bull Online trainings bull MnVFC Announcements sign up to receive them via email bull Ordering MDH vaccine bull MnVFC forms Screening forms Reporting forms Others MDH Nonviable Vaccine Form MDH Vaccine Transfer Record and Vaccine Borrowing Report
bull MnVFC promotional materials bull Immunization Billing Guidance for MnVFC and Immunization Billing Guidance for MnVFC Replacement Sites Immunization Practices Improvement Program (IPI) wwwhealthstatemnusdivsidepcimmunizeipi
bull IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml) bull IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml) IPI Resource Folder Contents (wwwhealthstatemnusdivsidepcimmunizeipiipifolderpdf)
Minnesota Immunization Information Connection (MIIC) wwwhealthstatemnusmiic
bull MIIC regions and regional coordinators
Clinical Practice MDH Immunization Program wwwhealthstatemnusimmunize
Got Your Shots News wwwhealthstatemnusdivsidepcnewslettersgys
MDH Immunization Information for Health Care Providers wwwhealthstatemnusdivsidepcimmunizehcp
bull Got Your Shots A Providers Guide to Immunization in Minnesota bull Vaccine protocols bull Forms for tracking patient immunizations bull Immunization schedules for Health Care Providers Immunization Action Coalition (IAC) wwwimmunizeorg
bull Ask the Experts bull VISs (Vaccine Information Statements and translations) bull Administration screening questions bull Medical management of vaccine reactions bull Order form for Californiarsquos Immunization Technique DVD Best Practices with Infants Children and Adults
Page 52 IPI Advisor Manual| February 2017
IPI Advisor Resource List Chapter 5
CDC ldquoPink Bookrdquo wwwcdcgovvaccinespubspinkbookindexhtml
CDC Advisory Committee on Immunization Practices (ACIP) wwwcdcgovvaccinesacip
CDC Vaccines and Immunizations wwwcdcgovvaccines
VAERS reporting httpvaershhsgovindex
Storage and Handling Got Your Shots Providers Guide ndash Managing Vaccine wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml
MnVFC Guide to Temperature Monitoring Devices wwwhealthstatemnusvfc
MDH Clinicianrsquos Vaccine Mishap Checklist wwwhealthstatemnusdivsidepcimmunizeipivaxchklstpdf
MDH Vaccine Storage Guide wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml
CDC Vaccine Storage and Handling Toolkit wwwcdcgovvaccinesrecsstoragetoolkit
You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Vaccine manufacturer phone numbers wwwcdcgovvaccinespubspinkbookdownloadsappendicesFcontact-info-manufactpdf
IAC Checklist for Safe Vaccine Handling and Storage wwwimmunizeorgcatgdp3035pdf
IAC Donrsquot Be Guilty of These Errors in Vaccine Storage and Handling wwwimmunizeorgcatgdp3036pdf
Additional Resources Print materials from MDH ndash order forms wwwhealthstatemnusdivsidepcimmunizeordermathtml
Vaccine Education Center ndash Childrenrsquos Hospital of Philadelphia wwwchopeduservicevaccine-education-centerhomehtml
California Department of Public Health ndash Interactive training on vaccine administration and storage and handling handout on transporting vaccine and how to package wwwezizorg
IPI Advisor Manual | February 2017 Page 53
IPI Advisor Resource List Chapter 5
CDC vaccine price list wwwcdcgovvaccinesprogramsvfcawardeesvaccine-managementprice-listindexhtml
Vaccine Information Statements (VIS) wwwcdcgovvaccineshcpvisindexhtml
CEU Opportunities CDC Immunization Education and Training wwwcdcgovvaccinesedindexhtml
Immunization You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Page 54 IPI Advisor Manual| February 2017
- Introduction
-
- Welcome to the Immunization Practice Improvement (IPI) Program
- Contact Information
-
- Chapter 1
- Requirements to Participate in the MnVFC Program
- Vaccines for Children Program
- Chapter 2
- Reimbursement for MnVFC Visits
- Types of Visits
- Your MnVFC Clinical CoordinatorPlanner
- New IPI Advisor Training Requirements
- Your Role as an IPI Advisor
- Reasons MDH Would Do All or Part of a Visit
- Chapter 3
- Future follow-up
- Conducting the Visit
- Preparing for the Visit
- Information for the Visit
- Site Visit Checklist
- Scheduling the Visit
- Chapter 4
- After the Site Visit
- MnVFC Provider Follow-up Plan
- MnVFC Site Visit Storage and Handling Per Unit Answer Sheet
- Section 6 Inventory
- Section 5 Storage amp Handling Site-Wide
- Section 4 Storage amp Handling Per Unit
- Section 3 Documentation
- Section 2 Eligibility
- Section 1 Provider Details
- The Site Visit Reviewer Legend
- MnVFC Site Visit Questionnaire
- Required Paperwork for Site Visits
- Chapter 5
-
Site Visits Chapter 3
Ending the Visit bull Fill out the two copies of the 2017 MnVFC Provider Follow-up Plan (or ask them to make a copy once it is completed for their records) Indicate if they have not met the requirement by checking the box in the ldquoUnmetrdquo column If they are not meeting requirements check the required actions Review the plan with them reinforcing the positive things they are doing as well as reviewing the required follow-up action(s) Give the site a copy of the Provider Follow-up Plan Keep the signed copy of the Provider Follow-up Plan to submit with your paperwork Do not leave a copy of the Site Visit Questionnaire at the site
bull Let them know you will be sending a thank you email that will summarize the site visit Included in the email will be a survey link you would appreciate them completing regarding the visit
After the Visit bull Send the site a thank you email There is a template thank you letter on the IPI Advisor Site Visit Materials (wwwhealthstate mnusdivsidepcimmunizeipisvmaterialshtml) page Be sure you include the issues that you identified and the timeline for their completion as well as the good things you found at the visit In the template letter be sure to include the survey link The survey is very brief ndash a few questions and space to write comments
bull Either transfer your MnVFC Site Visit Questionnaire and MnVFC Site Visit Storage amp Handling per Unit Answer Sheet information to the fillable version or submit the handwritten form to MDH
Documentation of the Visit
Paperwork must be submitted to MDH within 10 days of the visit in order to meet the federal VFC programrsquos reporting requirements Do not wait to complete your follow-up before submitting the site visit paperwork
Send the following documents to MDH bull 2017 MnVFC Site Visit Questionnaire (includes the cover sheet) bull 2017 MnVFC Site Visit Storage amp Handling per Unit Answer Sheet (one for each unit) bull 2017 MnVFC Provider Follow-up Plan (original signed plan)
Submit site visit materials to bull Email healthIPIinquiriesstatemnus (preferred) bull Mail IPI Program Specialist
Immunization Practices Improvement Program Minnesota Department of HealthPO Box 64975St Paul MN 55164-0975
IPI Advisor Manual | February 2017 Page 15
Site Visits Chapter 3
Future follow-up Follow-up is an important component of the site visit It helps us ensure that the unmet requirements have been corrected The questionnaire has different time periods for follow-up depending on the question Do not wait to complete your follow-up before submitting the site visit paperwork
When you complete the Follow-Up Form make sure to keep a copy for yourself MDH also keeps track of follow-up required and will remind you if follow-up has not been completed by the deadline Most follow-up can be done with a phone call or email In-person follow-up is rarely required and should be discussed with MDH before scheduling a follow-up visit
All requirements that need follow-up are identified with a [X] on the site visit paperwork and are listed on the MnVFC Provider Follow-up Plan
bull Follow-up with the site to see how they have resolved the unmet requirements bull Document your follow-up on the Follow-Up Form available on the IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml) page If follow-up was done via letter or email a copy can be attached to the Follow-Up Form
bull Send your Follow-Up Form to MDH (healthIPIinquiriesstatemnus) with supporting documents and emails
bull If a site is not responding to your requests regarding follow-up contact your MnVFC clinical coordinatorplanner They can help with additional follow-up as needed
Page 16 IPI Advisor Manual | February 2017
Chapter 4 The 2017 MnVFC Site Visit Paperwork This chapter will go through the required MnVFC site visit paperwork with notes about information or resources to help the site address questions or issues that may arise during the visit
The MnVFC site visit paperwork is available on the IPI Advisor Site Visit Materials (wwwhealthstate mnusdivsidepcimmunizeipisvmaterialshtml) page
Please download the paperwork shortly before your visit as there may be updates and changes and this will be the most up-to-date version of the questionnaire We will send out a Workspace message with major changes
Required Paperwork for Site Visits bull 2017 MnVFC Site Visit Questionnaire bull 2017 MnVFC Storage amp Handling Per Unit Answer Sheet ndash one for each unit assessed during site
visit bull 2017 MnVFC Provider Follow-up Plan ndash with provider signature
Make sure to include the sitersquos PIN on all your paperwork Please complete and submit your site visit paperwork as soon as possible after your visit It may be helpful to schedule some time into your calendar to complete your paperwork in the days following your visit Once you have completed the post-visit follow-up send in the Follow-Up Form with documentation of the follow-up actions Please do not wait until you have completed your follow-up before sending in your initial paperwork
MnVFC Site Visit Questionnaire The questionnaire includes these six sections 1 Provider details 2 Eligibility 3 Documentation 4 Storage amp handling per unit 5 Storage amp handling site-wide 6 Inventory
IPI Advisor Manual | February 2017 Page 17
Page 18 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
The Site Visit Reviewer Legend The legend explains the formatting of the 2017 questionnaire This includes information that will be helpful in completing the site visit
Site Visit Reviewer Guide Legend
Section Number Content Area
Question number This area will always contain the text of the question
Note to reviewer The note to reviewer contains information that is necessary for properly asking and assessing responses tothe question above This may include definitions of terms requirement details and other helpful tips
Answers This field will contain all the possible answer choices for this question For most questions answer choiceswill be followed by the markings below
Answer choices marked with an [X] indicate that this specific answer choice is non-compliant with a CDC requirement Answer choices marked with an [O] indicate that this specific answer choice is not aligned with a CDC
recommendation
Review CDC RequirementRecommendation
This field will be populated with the CDC requirementrecommendation associated with the given question
Actions if Non-Compliant
Root Cause Analysis As part of the site visit reviewers are required to assess and understand the reasons why a provider office isnon-compliant with VFC program requirements ndash this is a root cause analysis Reviewers must choose theone root cause that they believe most contributes to the non-compliance Upon establishing the root causethe reviewer must provide a clear explanation of hisher findings
Immediate Action These are actions that CDC requires reviewers to take on site during the visit
Future Follow-up These are future follow-up actions (with designated due dates) that are required of the reviewer andorprovider to remedy non-compliance Reviewers must complete all follow-up in accordance with CDCestablished deadlines
Notes Information you want the VFC program to be aware of or that explains your answer in detail
bull Note to reviewer These are notes to help you understand what the question is asking for and to clarify things you might want to know when asking or rephrasing the question
bull Answers This section helps you to know when the answer does not meet the CDC requirement [X] or recommendation [O] Whenever an answer with a [X] is checked the ldquoActions if Non-compliant section must be completed The recommendations are usually good teaching points about best practices andor future requirements of the VFC program
bull Review the CDC RequirementRecommendation This section provides a specific outline of the requirement or recommendation to give you information to use in talking with the site staff
bull Actions if Non-Compliant This section describes what to do if the site is not meeting a requirement Root cause analysis This section asks you to probe beyond the surface to find what is driving the non-compliance It is intended to help uncover reasons for recurring non-compliance issues identify additional training needs and inform reviewer follow-up actions Select only one root cause and explain the particular circumstances in the space ldquoExplanation of root causerdquo line provided If there appear to be multiple issues choose the one that most contributes to the non-compliance and describe all factors in the explanation Immediate actions A list of actions to take during the site visit to address the issue Future follow-up A list of actions to take after the site visit by the set deadline
bull Notes This section can be used for notes to yourself or to MDH
IPI Advisor Manual | February 2017 Page 19
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 1 Provider Details Questionnaire Coversheet
The first page of the questionnaire collects the demographic information for the site You can use this page to help prepare for the visit Most of the demographic information about the site should be on the site-specific document you received with your clinic list You will validate that this information is current at the time of the site visit It also helps to know if this is a separate stock site or a replacement site before the visit so you can bring a copy of the appropriate MnVFC Policies and Procedure Manual
2017 MnVFC Site Visit Questionnaire Date of visit _____________ Date forms sent to MDH ______________
Site Information
Site name MnVFC PIN
Address Separate Stock Replacement
City ZIP County
Medical Director Email
Immunization Manager Phone
Vaccine Coordinator Phone
Vaccine Coordinator back-up Email
Point of contact Phone
Personnel at site visit
On this page bull The date of the visit and the date when you send these forms to MDH This information helps us track the timeliness of our review and data entry process
bull The vaccine management method used by the site (replacement or separate stock) bull The name and email of the medical director (ideally this is the person who signed the MnVFC
Program Provider Agreement)bull Contact information for the immunization manager vaccine coordinator vaccine coordinator back-up and point-of-contact for this visit The immunization manager vaccine coordinator vaccine coordinator back-up roles are
described in the MnVFC Policies and Procedure Manual The vaccine coordinator back-up may be the immunization manager or another staff person depending on the size of the site and available personnel The Point of Contact is the person you set up the appointment with signs the Provider Follow-
up Plan and receives the follow-up email This may be one of the people listed above
The Post Visit Steps section is a reminder to you about what needs to done after the visit The Education on Immunization Best Practices for Sites section reminds you to provide the resource folder to the site
Page 20 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 12
1 Provider Details Changes to Key Staff
Question 12 Ask the provider about changes to key staff to answer the questions below
A (Choose all that
apply)
At the time of the visit is the Medical Director the same individual that signed the ProviderAgreement and are the Immunization Manager and Vaccine Coordinator the same asthose last reported to the program
Yes No the Medical Director has changed No the Immunization Manager has changed No the Vaccine Coordinator has changed
B (Choose one)
Were all changes communicated to theImmunization Program according to yourprogramrsquos policy
Yes or no staff changes No [X]
C (Choose one)
Based on review of the trainingdocumentation have the current Immunization Manager Vaccine Coordinator and back-up completed all required training
Yes No [X]
Review CDC Requirement
All changes in key staff must be communicated to the Immunization Program in the manner and timeframe defined by theImmunization Program Key staff include the Medical Director or equivalent who signed the Provider Agreement the Immunization Manager Vaccine Coordinator and the back-up VFC providers are required to ensure that all key staff are fully trained on VFC program requirements at all times All training must be documented
Goal of this question Determine if there are new staff in key positions at the site and to make sure staff are properly educated about the MnVFC program A This information can help you determine the level of knowledge and experience the staff have with the MnVFC program Follow-up throughout the visit can be tailored for various levels of staff experience Likewise you may identify additional training needs for new staff
B When sites notify us of changes in key personnel we update their information in MIIC and on the clinic lists We also send the new staff information for completing the online training and direct them to read the appropriate MnVFC Policies and Procedures Manual If the answer to this part is no update the demographic area of the questionnaire and inform the staff that in the future they must notify the MnVFC program (via email or phone) if the immunization manager or vaccine coordinator changes Resource Section 12 of the MnVFC Policies and Procedures Manual
C Annual training must be verified by looking at the certificates for the online training If the answer to this part is no refer the staff to complete the appropriate MnVFC online training found on the MnVFC website (wwwhealthstatemnusvfc) for their program (separate stockreplacement) for the current year and send you a copy of the certificate within 30 days
Resource bull Sections 12 and 14 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 21
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 2 Eligibility Question 21
Goal of this Question Assess whether staff correctly understand which patients are eligible for the MnVFC program Screening ensures that eligible children receive the vaccines that they are entitled to receive under the MnVFC program and helps to prevent fraud or abuse of the program
Children 18 years and younger in these
categories can receive MnVFC vaccine at any enrolled site bull Uninsured bull Enrolled in a Minnesota Health Care Program (MHCP) Medical Assistance (MA) or MinnesotaCare bull American Indian or Alaskan Native
The following categories are considered underinsured and are only MnVFC-eligible at local public health (LPH) Federally Qualified Health Centers (FQHC) Rural Health Centers (RHC) Indian Health Services (IHS) and tribal health clinics
bull Has health insurance that does not cover one or more vaccines as can be the case with newly licensed vaccines that arenrsquot yet covered (MnVFC-eligible for non-covered vaccines only)
bull Has health insurance that caps vaccine coverage at a certain amount Once that amount is reached the child is MnVFC-eligible
Children with insurance that does not cover vaccines until a deductible has been met are considered to be fully insured and are not MnVFC-eligible
Helpful information bull Sites are not required to verify the patientrsquos response to the screening questions For example if a patient states they lost their insurance the site does not need to call the patientrsquos insurance company to confirm
If the site cannot correctly describe the eligibility categories provide educational materialsresources on MnVFC eligibility requirements
Resources bull Patient Eligibility Screening Record on MnVFC Forms (wwwhealthstatemnusdivsidepc immunizemnvfcformshtml)
bull Section 1 of the MnVFC Policies and Procedures Manual
2 Eligibility VFC Eligibility Categories
Question 21 Was the individual responsible for determining patient VFC eligibility able to explain all the factors(including age) that make a child eligible to receive VFC vaccines
A Patient is less than 19 years of age Yes No [X]
B Patient is Medicaid-eligible Yes No [X]
C Patient is uninsured Yes No [X]
D Patient is underinsured Yes No [X]
E Patient is American Indian Yes No [X]
F Patient is Alaska Native Yes No [X]
Review CDC Requirement
VFC providers must possess a working knowledge of all VFC eligibility criteria and use those criteria to screen children prior toadministering VFC vaccines In order to receive VFC vaccine a patient must be under the age of 19 and must be at least one of the following (1) Medicaid-eligible (2) Uninsured (ie child has no health insurance) (3) Underinsured (ie child has health insurancebut coverage does not cover any or certain vaccines ndash underinsured children may only receive VFC vaccines in FQHCRHC ordeputized VFC provider offices and only for vaccines not covered by insurance) and (4) American Indian or Alaska Native (AIAN)
Page 22 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 22
2 Eligibility Billing Practices
Question 22 Is the individualdepartment responsible for billing able to clearly explain how they bill for both the costof vaccine and the vaccine administration fee for each of the eligibility categories below
A Medicaid-eligible Cost of Vaccine Do not bill ndash provided by VFC Admin Fee Bill Medicaid
Yes No [X]
B Uninsured Cost of Vaccine Do not bill ndash provided by VFC Admin Fee If billing can bill patient
Yes No [X]
C Underinsured Cost of Vaccine Do not bill ndash provided by VFC through FQHCsRHCs or deputized providers only all other providers cannotprovide VFC vaccine to underinsured patients Admin Fee If billing can bill patient
Yes No [X]
D American IndianAlaska Native(AIAN)
Cost of Vaccine Do not bill - provided by VFC unless patient is fully insured and parent chooses to use insurance Admin Fee If patient is Medicaid-eligible bill Medicaid if billingand patient is uninsuredunderinsured can bill patient if parentchooses to use private insurance for cost of vaccine billpatientinsurance
Yes No [X]
E Do individuals responsible for billing have access to the results of eligibility screening toensure proper billing
Yes No [X]
Review CDC Requirement
VFC providers must adhere to proper billing practices for vaccine administration fees and clearly understand that VFC vaccine isprovided at no cost to both the VFC provider and eligible children At no time should billing occur for the cost of VFC vaccine Whenadministering VFC vaccine providers should never bill two different ldquopayersrdquo (ie patient Medicaid insurance) for the samevaccine administration fee amount For Medicaid-eligible children Medicaid should be billed for the vaccine administration fee Forall other VFC-eligible populations the patient may be billed within the stateterritory cap established by the Centers for Medicareand Medicaid (CMS) However patients cannot be turned away or reported to collections for inability to pay the administration fee
Goal of this question Determine if the staff correctly understand how to bill patients that are eligible for the MnVFC program Billing appropriately ensures that children can receive low cost immunizations and the site is in compliance with the VFC program
bull If there is any indication that sites could be billing insurance companies or parents for VFC vaccines this should be investigated further
bull Most sites in Minnesota will bill Medicaid with the SL modifier ndash which indicates this is a Medicaid claim
bull The main point is to ensure the site is not billing uninsured children for VFC vaccine and are not charging them more than $2122 per vaccine for the administration fee
bull Non-compliance is usually unintentional and may be resolved with some training In rare cases it could be a glimpse into a larger problem where a site is intentionally billing for financial gain
bull If you think the site is billing inappropriately it is the responsibility of the IPI advisor to report concerns to MDH staff for further assistance
Resources bull Immunization Billing Guidance for MnVFC (wwwhealthstatemnusdivsidepcimmunizemnvfc billingtipshtml) or Immunization Billing Guidance for MnVFC Replacement Method Sites (www healthstatemnusdivsidepcimmunizemnvfcreplacementbillingtipsrephtml)
bull Section 2 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 23
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 232 Eligibility Vaccine Administration Fee
Question 23 Document the actual vaccine administration fee charged to non-Medicaid VFC-eligible patients (confirmwith billing department)
Answers Fee $ [X] Follow-up is required if the provider charges more than the fee cap establishedby the Centers for Medicare and Medicaid (CMS) for your stateterritory ($2122)
Review CDC Requirement
The VFC providerrsquos vaccine administration fee for non-Medicaid VFC-eligible children must not exceed the stateterritory vaccineadministration fee cap established by the Centers for Medicare and Medicaid (CMS) For current fee caps refer to Medicaid Program Payments for Services Furnished by Certain Primary Care Physicians and Charges for Vaccine Administration Under theVaccines for Children Program Final Rule (httpwwwgpogovfdsyspkgFR-2012-11-06pdf2012-26507pdf)
Goal of this question Ensure that sites are not charging more than the federal allowable vaccine administration fee of $2122
bull The Centers for Medicaid and Medicare (CMS) establishes a maximum fee that sites can charge to non-Medicaid-eligible VFC patients in each stateterritory for vaccine administration Health Plans usually negotiate this fee with the site but Medicaid will not pay more
bull If a parent cannot pay the vaccine administration fee the patient cannot be turned away or reported to collections VFC-eligible children must be vaccinated regardless of their ability to pay
bull If the person with whom you are conducting the site visit does not know the exact fee charged to non-Medicaid VFC-eligible patients ask to speak to someone who can verify the exact amount
bull If they are charging more than $2122 for the administration fee ndash please contact MDH staff for help with addressing this situation
Resources bull Immunization Billing Guidance for MnVFC (wwwhealthstatemnusdivsidepcimmunizemnvfc billingtipshtml) or Immunization Billing Guidance for MnVFC Replacement Method Sites (www healthstatemnusdivsidepcimmunizemnvfcreplacementbillingtipsrephtml)
bull Section 2 of the MnVFC Policies and Procedures Manual
Page 24 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 3 Documentation Question 31
3 Documentation Eligibility Screening amp Documentation
Question 31 To answer the questions below the provider must clearly demonstrate the patient intake processReview a minimum of 10 records that contain an immunization visit within the last 6 ndash 12 months
Note to Reviewer Criteria for Record Selection 1) Record selection must be completely random and the provider must not know prior to the visit which
records will be reviewed 2) Patient must have been 0-19 years of age at the last visit (Note Records of 19-year-old patients may
allow you to see if VFC vaccines are being used beyond the allowable age) 3) Must review a mix of public and private-pay patients (if applicable)
A Does the provider have a process that ensures that patients are screened forVFC eligibility at each visit and that screening results are documented at each visit
Yes No [X] (If no skip question F)
B Does the providerrsquos process ensure that staff administering vaccine know which vaccine stock to select from prior to drawing the vaccine
Yes No [X]
C Number of records reviewed If fewer than 10 records are reviewed select the reason why Provider does not have 10 patient records with immunizations in last 12 months
D Do all records contain date of the immunization visit and patientrsquos date of birth Yes No [X]
E Do all records contain the patientrsquos specific eligibility status associated with thedate of the immunization
Yes No [X]
F Do any of the providerrsquos records contain any evidence that the patient received vaccine for which they were not eligible
Yes [X] No
Review CDC Requirement
VFC providers must screen for and document VFC eligibility at each immunization visit Documentation must include the date of the visit and the childrsquos specific eligibility category VFC providers must use screening results to ensure that only VFC-eligible children receive VFC vaccine and that administration fees are billed for as appropriate Eligibility status must be readily available to staff administering vaccine prior to selecting which vaccine stock to use
Goal of this question Ensure the site is screening for eligibility and documenting the eligibility category in the medical record
Review a minimum of 10 records from within the last 6-12 months where the patient received an immunization You must review a mix of public and private pay patients (if applicable)
Random selection is important If the staff have pre-selected records for review do not use and identify additional randomly selected records to review
Helpful information bull Discuss upgrading the electronic health record to make documentation of VFC eligibility screening a required field Documenting eligibility screening in the immunization field promotes better MIIC data
bull Q 31 B Sites using the replacement method of vaccine management only have one stock so you will answer ldquoYesrdquo to this question
Resources bull Patient Eligibility Screening Record on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfcformshtml)
bull Section 1 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 25
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 32
3 Documentation Vaccine Dose Documentation
Question 32 Review a minimum of 10 patient immunization records from the last six months (or 12 months ifnecessary) to assess compliance with documentation requirements set forth by Statute 42 US Code 300aa-25 (See note to reviewer below)
Note to Reviewer Criteria for Record Selection 1) Record selection must be completely random the Provider must not know prior to the visit which records
will be reviewed 2) Patient must have been 0-19 years of age at the last visit (Note Records of 19-year-old patients may allow
you to see if VFC vaccines are being used beyond the allowable age)
Records are Compliant if they Contain ALL the Below Elements
bull Address of clinic where vaccine was administered bull Publication date of VIS bull Name of vaccine administered bull Name of vaccine manufacturer bull Date vaccine was administered bull Lot number bull Date VIS was given bull Name and title of person who administered the
vaccine
A Number of records reviewed
B Number of records that contain ALL required documentation elements
If fewer than 10 records are reviewed select the reason why Provider does not have 10 patient records with immunizations in last 12 months
[X] Follow-up isrequired if one ormore records do not meet requirements
Goal of this question Assess whether the site is documenting all required information in each patientrsquos medical record for every vaccine dose administered in accordance with the National Childhood Vaccine Injury Act
Resources bull Section 6 of the MnVFC Policies and Procedures Manual bull National Vaccine Injury Compensation Program (wwwhrsagovvaccinecompensation)
Question 33
3 Documentation Record Retention
Question 33 Is the provider able to demonstrate (preferred) or clearly describe how they maintain historical VFCeligibility documentation for three years
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers are required to maintain all records related to the VFC program for a minimum of three years (or longer if requiredby state law) and upon request make these records available for review VFC records include but are not limited to VFC screening and eligibility documentation billing records medical records that verify receipt of vaccine vaccine ordering records and vaccinepurchase and accountability records
Goal of this question Make sure the site understands they are required to keep all MnVFC screening documentation for at least three years either electronically or on paper This information should be available to you at the time of the visit and future visits
Resource bull Section 7 of the MnVFC Policies and Procedures Manual
Page 26 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 34
3 Documentation Borrowing Documentation
Question 34 Discuss borrowing practices with the provider to answer the questions below
Note to Reviewer bull To be considered ldquofully documentedrdquo documentation for each borrowed dose must include thefollowing information
Vaccine type borrowed Date the dose was administered Stock used (VFC or private) Reason appropriate vaccine stock was not used Patient name and date of birth Date dose was returned to appropriate stock
A Did the provider state that they had borrowed any vaccines (whetherdocumented or not) since the last VFC Compliance Site Visit
Yes No (If no skip to question 36)
B Are there any doses for which there is no documentation (ie provider hasindicated that doses were borrowed but cannot verify how many or why)
All doses are documented Some doses are not documented [X] No doses are documented [X] (if nodoses documented skip toquestion 36)
C Were all borrowed doses fully documented (See Note to Reviewer above) Yes No [X]
D Were all borrowed VFC doses either replaced or an order submitted to replacethe doses Yes No [X]
Review CDC Requirement
VFC providers are expected to maintain an adequate inventory of vaccine for VFC and non-VFC-eligible patients It is theresponsibility of the VFC provider to appropriately schedule and place vaccine orders VFC providers must also rotate stock to ensure timely use of short-dated vaccines Borrowing of vaccine between private and public inventories must be a rare unplanned occurrence and cannot serve as a replacement system for a VFC providerrsquos privately purchased vaccine inventory All instances ofborrowing must be properly documented reported and replaced
Goal of this question Assess vaccine accountability by verifying that children are receiving vaccine from the appropriate stock
Borrowing is when a fully insured child receives a dose of MnVFC vaccine or a MnVFC-eligible child receives a dose of private vaccine This should be a rare unplanned occurrence The site must document any borrowing of vaccine between stocks ideally on the VFC Borrowing Report Form If they are not currently using the form review it with them and encourage them to post it close to their vaccines It does not need to be sent to MDH but should be kept for 3 years and filed with their MnVFC documents to be reviewed whenever they have a regular or unscheduled (unannounced) site visit
Helpful information bull Understand and report on staffrsquos verbal (ie anecdotal) accounts of borrowing obtained during the visit Often sites do not know that what they do is considered borrowing or they think borrowing is acceptable and documentation isnrsquot needed so long as those vaccines are eventually replaced
bull Since sites using the replacement method only have one stock of vaccine they very rarely borrow bull This question asks for future follow-up in 6 months Make a note on your calendar and ask them to send you a copy of their borrowing reports for the previous 6 months with documentation of doses borrowed and replaced We will remind you if we donrsquot hear from you at the 6 month time frame Complete the Follow-up Form and attach the borrowing form
Resources bull Vaccine Borrowing Report on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfc formshtml)
bull Section 10 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 27
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 353 Documentation Borrowing Reasons
Question 35 Based on your discussion with the provider and a review of borrowing reports document the dosesborrowed for each reason and answer the questions below
Note to Reviewer bull Short-dated vaccines are doses that are likely to expire before they can be used bull Exchanging short-dated vaccines should only occur in practices that have a small number of private
patients
A Reasons for Borrowing a VFC Dose (Enter the number of _____ Private vaccine shipment delay (order placed on time but delay in shippingreceipt)
vaccine doses borrowed for each
reason in the spaces
_____ Private vaccine not useable on arrival (vials broken temperature monitor out of range) _____ Ran out of private vaccine between orders (provider orders not placed on time) [X]
provided) _____ Short-dated private dose was exchanged with VFC stock _____ Accidental use of VFC dose for a private patient (human error) _____ Replacement of private dose with VFC when insurance plan did not cover vaccine _____ OtherDocumented dose did not include reason for borrowing [X]
(Explanation Required) Reasons for Borrowing a Private Dose _____ VFC vaccine shipment delay (order placed on time but delay in shippingreceipt) _____ VFC vaccine not useable on arrival (vials broken temperature monitor out of range) _____ Ran out of VFC stock between orders (provider orders not placed on time) [X] _____ Short-dated VFC vaccine dose was exchanged with private dose _____ Accidental use of a private dose for a VFC-eligible patient (human error) _____ OtherDocumented dose did not include reason for borrowing [X]
(Explanation Required)
B Enter date range for instances of borrowing reviewed in the borrowing report Note If ldquoDate of earliest instancerdquo is not available use the date of the last VFC Compliance Visit If ldquoDate of last instancerdquo is not available use the date of thecurrent VFC Compliance Visit
Date of earliest instance
Date of last instance
C Does borrowing appear to be a routine practice Note To determine whether borrowing is a routine practice assess frequency of and repeating reasons for borrowing Examples Frequent accidental use of incorrect stock exchanging short-dated vaccines or issues with ordering and shipment
Yes [X] No
Goal of this question Determine the reasons why the site is borrowing vaccine
If sites are using the Vaccine Borrowing Report review the reasons for borrowing to help document borrowed VFC andor private doses If they have not been documenting borrowing on this report (or any other form) estimate their borrowing practices If you do not know the date range for their borrowing use the last site visit date to the current visit date The use of ldquootherrdquo as the reported reason for borrowing should be rare if ever and would require explanation and follow up
Helpful information bull Look to see if they routinely maintain insufficient amounts or types of vaccine to support their public and private patients that leads to borrowing
bull Pay attention to borrowing cases documented as ldquoaccidentalrdquo Repetitive accidental borrowing may indicate an issue with ordering processes or insufficient staff training
bull Borrowing is not a place to document wasted or lost doses bull The time period of the borrowing may give you clues about the root cause Were the borrowed doses concentrated in a short period or spread out across several months or a year Are all vaccine types being borrowed or just one
bull If borrowing seems to be an issue discuss vaccine management ordering procedures
Resources bull Vaccine Borrowing Report on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfc formshtml)
bull Section 10 in the MnVFC Policies and Procedures Manual
Page 28 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 36
3 Documentation Vaccine Management Plan
Question 36 Physically review the providerrsquos Vaccine Management Plan to answer the question below
A Does the provider have a Vaccine Management Plan Yes No [X] (If no skip to question 37)
B Does the plan list the current Immunization Manager Vaccine Coordinator andback-up
Yes No [X]
C Does the plan address proper vaccine storage and handling practices Yes No [X]
D Does the plan specify vaccine receiving procedures Yes No [X]
E Does the plan contain procedures for what to do with vaccine in the event of an emergency
Yes No [X]
F Does the plan contain procedures for vaccine ordering Yes No [X]
G Does the plan address inventory control (example stock rotation) Yes No [X]
H Does the plan address how to handle vaccine wastage Yes No [X]
I Does the plan address staff training and documentation on vaccine managementstorage amp handling
Yes No [X]
J Does the plan contain a review date that falls within the last 12 months Yes No [X]
K Has the plan been signed by the individual responsible for its content Yes No [X]
Review CDC Requirement
VFC providers must develop maintain and implement a Vaccine Management Plan for routine and emergency vaccinemanagement The plan must contain the current Vaccine Coordinator and back-up proper storage and handling practicesshipping and receiving procedures emergency procedures procedures for vaccine ordering inventory control (eg stock rotation)how to handle vaccine wastage and staff trainingdocumentation on vaccine management storage and handling The plan must bereviewedupdated annually or more frequently if changes occur A ldquoreview daterdquo and signature are required on all plans in order tovalidate that they are current
Goal of this question Evaluate the sitersquos plan for vaccine management It is especially important that they have a plan for emergency management of their vaccine in the case of equipment failure or power outage Encourage all sites to read and sign the MnVFC Policies and Procedures Manual and complete the emergency plan or be able to show you a plan of their own
If the provider is not able to physically show you the plan at the time of the visit or if the recorded review date is not within the last 12 months you must mark that this requirement is unmet The Vaccine Management Plan is important in times of emergency and it should be easy to access by any staff member at any time Encourage them to post the plan and put a copy with the packing supplies
Helpful information bull Encourage the site to fill in the ldquoImmunization Managerrdquo and ldquoVaccine Coordinatorrdquo fields in the
MnVFC Policies and Procedures Manual for their own referencebull The emergency plan in the manual can be reviewed from last year and included in this yearrsquos manual (with an updated signature and date) if there have not been any changes
bull If information in the plan is outdated site staff will not be well equipped to safely manage vaccines in the event of a power-outage or other emergency situation
bull If their institutional policy is only reviewed and updated every 3-4 years (as many are) the staff may need to sign the MnVFC Polices and Procedure Manual to meet this requirement
Resource Routine Vaccine Management Plan and Emergency Vaccine Management Plan in the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 29
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 37
3 Documentation VIS amp VAERS
Question 37 Review the providerrsquos Vaccine Information Statements (VISs) and discuss providerrsquos VAERS process toanswer the questions below
A Does the provider have readily available up-to-date VISs for all ACIP-recommendedvaccines relevant to the populations it serves
Yes No [X]
B Does the provider make a VIS available for patientsparents before eachvaccination
Yes No [X]
C Does the provider know how and when to report clinically significant adverseevents using VAERS
Yes No [X]
Review CDC Requirement
VFC providers are required to distribute the current Vaccine Information Statements (VIS) each time a vaccine is administered and maintain records in accordance with the National Childhood Vaccine Injury Act (NCVIA) which includes reporting clinicallysignificant adverse events to the Vaccine Adverse Event Reporting System (VAERS) For a list of current VISs visit CDCrsquos Vaccine Information Statements (httpwwwcdcgovvaccineshcpvis) website
Gal of this question Ensure the site has the most current VISs and is giving them to each patientparent before administering the vaccine in compliance with the federal law Parents must be educated about the vaccine their child will receive and be aware of possible contraindications and side-effects in order to make well-informed decisions about their childrsquos health
Helpful information bull Ask to see the sitersquos VISs to determine if they have an active protocol for giving VISs to parents Review to make sure they are current Ask if they know where and how to report vaccine adverse events
Resources bull Section 3 in the MnVFC Policies and Procedures Manual bull CDC Vaccine Information Statements (wwwcdcgovvaccineshcpvisindexhtml) Site may sign up for email updates for the current list of VIS publication dates for the most up-to-date version
bull IAC Itrsquos Federal Law You must give your patients current Vaccine Information Statements (wwwimmunizeorgcatgdp2027pdf)
bull VAERS (httpsvaershhsgovindex)
Question 38
3 Documentation Anaphylaxis protocol
Question 38 Does the site have an anaphylaxis protocol which is clearly posted near the emergency kit
Answers (Choose one)
Yes No [X]
Review CDC Requirement
An anaphylaxis protocol must be clearly posted in the area where vaccines are administered
Goal of this question Make sure site is prepared for a severe allergic or anaphylactic reaction to a vaccine
Resources bull Section 11 in the MnVFC Policies and Procedures Manual bull IAC protocols Child and Teens (wwwimmunizeorgcatgdp3082apdf) and Adults (wwwimmunize orgcatgdp3082pdf)
Page 30 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
i
i i i - li i i i i i l
Section 4 Storage amp Handling Per Unit The goal of this section is to assess vaccine storage
2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet practices in each unit at the site MnVFC PIN ___________________
The 2017 MnVFC Storage amp Handling Per Unit Answer Sheet is a worksheet to document the answers to the questions in this section for each unit (combination or stand-alone) Fill in the answers to the questions in Section 4 on the answer sheet not in the questionnaire
The answer sheet has an abbreviated form of each question If you need further information on that question refer back to the full questionnaire Also if you find an area where the site is not meeting the requirements you will need to go back to that question on the 2017 MnVFC Site Visit Questionnaire to complete ldquoActions if Non- compliantrdquo section including the root cause analysis and follow-up sections If there is a problem in more than one unit make a note on the questionnaire which unit you are referring to in the Notes section
Important You must fully assess any unit that may be used to store VFC vaccines even if there are no VFC vaccines there on the day of the visit If there are no vaccines and the site is not documenting twice a day temperatures discuss the need to ensure the unit is maintaining stable temperatures by monitoring for one week before placing vaccines in the unit
Quest on number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
for the freezer and e co umn
Temperature Monitoring Dev refr gerator f the un
ce Quest ons Quest ons 4 3 4 7 must be answered separate y t s a combo Be sure to document responses n the appropr at
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
44D Data downloaded and reviewed routinely (eg weekly)
Yes No [O]
Yes No [O]
45A Certificate of Calibration Testing Yes No [X]
Yes No [X]
45B Date of calibration
45C Date certificate expires [X] Follow-up is required if expired [X] Follow-up is required if expired
45D Certificate contains all necessary items
Yes No [X]
Yes No [X]
46 Probe properly placed Yes No [X]
Yes No [X]
47A Two temperature readings per day
Yes No [X]
Yes No [X]
47B Time date and name (or initials) for each reading
Yes No [X]
Yes No [X]
47C Current temperature and minmax temperatures (if
Current ________deg Minimum ________deg Maximum _deg
Current ________deg Minimum ________deg Maximum _deg
Sections 5 and 6 contain questions about storage and handling site wide and inventory It is helpful to keep those questions in mind as you assess the individual storage units Think about dorm-style units expired vaccine vaccine supply room for vaccine stocking all the recommended vaccines and separation of stock if appropriate
NOTE The sections that follow require reviewers to validate responses by looking at vaccine storage units temperaturemonitoring equipment and the vaccine inventory inside a unit bull For section 4 use a separate Storage amp Handling Per Unit Answer Sheet for each unit to document the findings (combination
units using both sections can be documented on the same answer sheet) bull When an unmet requirement is identified return to this questionnaire to complete the ldquoActions if Non-compliantrdquo section for
that question bull After you complete one answer sheet for each unit return to the questionnaire to complete sections 5 and 6 using information
you gathered while assessing the units The questions in sections 5 and 6 (Storage amp Handling Site-Wide and Inventory) are notunit-specific but do require that the response be based on a thorough assessment of all the providersrsquo units
4 Storage amp Handling Per Unit
Description On the Storage amp Handling Per Unit Answer Sheet place a name that will allow you or someone else from your program to easily identify this unit in the event of follow-up We recommend using Brand + Location(example Samsung - Room 123) Save each Storage amp Handling Per Unit Answer Sheet with the Brand + Location in the file name
(example SamsungRoom123doc)
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The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 41
4 Storage amp Handling Per Unit Storage Unit Build amp Use
Question 41 Below select the build and use of the vaccine storage unit you are assessing
Note to Reviewer Dorm-style units Do not add dorm-style units here Dorm-style units will be addressed in section 5 Units storing only private stock You must review these storage units even if they contain only private stockat the time of the visit because that vaccine could be administered to VFC patients
A What type of unit is this A Stand-alone B Combination
B Select use if stand-alone A Freezer B Refrigerator
Select use if combination A Use both sections to store vaccine B Use freezer section only to store vaccine C Use refrigerator section only to store vaccine
Goal of this question Identify the unit you are evaluating The description asks you to create a unique name for this unit so that you will be able to identify the same unit in future site visits Put this description on the top of the answer sheet (ie make and location)
Helpful information bull A stand-alone unit is either a refrigerator or a freezer It does not have both sections in the unit bull If there is a combination unit note if the site uses both the refrigerator and freezer or only one section of the unit to store vaccines CDC does not recommend the use of either section or the freezer section only of combination household units
bull If your site utilizes the separate stock method of vaccine management you must review storage units even if they contain only private stock at the time of the visit because there is a chance that those vaccines could be administered (borrowed) to VFC-eligible patients
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The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 424 Storage amp Handling Per Unit CDC Recommended Storage Units
Question 42 Below document the grade of the vaccine storage unit you are assessing
Note to Reviewer Pharmaceutical Also called ldquopurpose-builtrdquo these units are designed by the manufacturer specifically tostore vaccines or other biological materials Commercial Although usually intended to store food and beverages commercial units are often larger and more powerful than the household units found in most homes Though these units are intended to meet thehigher demands of larger facilities these units are not specifically built for the storage of biologicalmaterials Household (non-commercialdomestic) These units are usually smaller than commercial units and areintended for use in small offices and in homes ndash typically for food storage However just like commercialunits they are not designed specifically for the storage of biological materials Such units are usually available in common home supply stores
Answers (Choose one)
Select grade A Pharmaceutical B CommercialHousehold
[O] CDC does not recommend the use of both sections or the freezer section only of combination commercialhousehold units
Review CDC Recommendation
CDC recommends the following vaccine storage unit types (in order of preference) pharmaceutical grade stand-alone orcombination units (preferred) householdcommercial stand-alone units householdcommercial combination units using therefrigerator section only
Goal of this question Assess the grade and type of each storage unit bull Pharmaceutical grade units may be stand-alone or combination units that are often metal may have glass in the door for viewing inside often have an external digital temperature display and are manufactured by medical companies
bull Commercial or household units often look like your kitchen appliance have vegetablemeat drawers in the unit and are manufactured by household appliance companies
bull Occasionally you might find a medical grade unit which is usually a commercialhousehold unit with a lock and 3-prong plug These are still considered household units because of their ability to maintain proper temperatures and air flow Studies show that household stand-alone units are better able to maintain consistent temperatures than their combination counterparts Combination household units used to store vaccine in both sections of the unit is no longer recommended and may be prohibited in the future Combination household storage units that are having difficulty maintaining a cold enough freezer temperature and a warm enough refrigerator temperature should be replaced or a separate stand-alone freezer should be purchased
For frozen vaccines the most cost effective solution is for the site to purchase a small stand-alone freezer The site may need time to budget for a stand-alone storage unit
Resources bull Replacing Combination Household Units Tip Sheet on IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml)
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The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 434 Storage amp Handling Per Unit Temperature Monitoring Device in the Unit
Question 43 Determine whether there is a temperature monitoring device in this section of the storage unit andanswer the questions
A Is there a temperature monitoring device in this section of thestorage unit
Yes No [X] (If no skip to question 47)
B Who is responsible for supplying the temperature monitoring device in this section of the storage unit Provider
Review CDC Requirement
Certificates of calibration testing provide confidence that the temperature monitoring device is measuring temperaturesaccurately All units storing VFC vaccines must have a calibrated temperature monitoring device with a current and valid certificateof calibration testing All certificates must contain modeldevice name or number serial number date of calibration testing (report or issue date) and Instrument Passed testingInstrument in Tolerance (Recommended uncertainty = +-05ordm C (+-1ordm F))
Goal of this question Assess whether there is a temperature monitoring device in the unit If the unit is not being monitored at all call MDH at 651-201-5522 for guidance
Helpful information bull This question does not ask whether the temperature monitoring device is working or the characteristics of the device These issues will be addressed later in the questionnaire
bull For part B the provider is always responsible for supplying the temperature monitoring device Even if their thermometer or data logger was originally from MDH it is their responsibility to ensure it is functional and calibrated
Resources bull Section 8 in the MnVFC Policies and Procedures Manual
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The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 444 Storage amp Handling Per Unit CDC Recommended Temperature Monitoring Device
Question 44 Assess the temperature monitoring device in this section of the storage unit to answer the questionsbelow
A Is the temperature monitoring device a continuous monitoring and recordingdevice (eg data logger)
Yes No [O] (Skip D)
B Does the temperature monitoring device have a probe in buffered material Yes No [O]
C Does the temperature monitoring device have a digital display that can beeasily read from the outside of this unit
Yes No [O]
D Is data downloaded and reviewed routinely Yes No [O]
Review CDC Recommendation
As of Jan 1 2018 all VFC providers must use continuous temperature monitoring devices (eg data loggers) to monitor vaccinesthat will be administered to VFC-eligible children Routine review and accessibility of temperature data is critical for determining whether vaccine has been properly stored and for assessing usability of vaccine that was involved in a temperature excursion Tomeet VFC Program requirements the device must also be equipped with bull A temperature probe bull An active temperature display that can be easily read from the outside of the unit bull The capacity for continuous monitoring and recording capabilities where the data can be routinely downloaded
The following are additional recommended features for these devices bull Alarm for out-of-range temperatures bull Current minimum and maximum temperatures display bull Low battery indicator bull Accuracy of +- 1degF (05degC) bull Memory storage of at least 4000 readings bull User programmable logging interval (or reading rate) recommended at a maximum time interval of every 30 minutes bull Use of a probe that best reflects the temperature of the vaccine (such as a buffered probe)
Goal of this question Assess the temperature monitoring device in the storage unit Note that these are all recommendations not requirements at this time
This is a great teaching opportunity for sites who do not currently have a continuous temperature monitoring device Beginning Jan 1 2018 all units that store MnVFC vaccine will be required to have a continuous temperature monitoring device (ie a data logger or a continuous temperature monitoring system) Unlike a minmax thermometer a continuous temperature monitoring device provides detailed information on all temperatures recorded at pre-set intervals For excursions it can provide information on when a temperature went out-of-range for how long and what the temperatures were This is essential information that vaccine manufacturers need to know to assess the viability of the vaccine following an excursion
Helpful information bull Sites are required to monitor and record temperatures twice daily however temperature excursions can easily occur in the 12 hours or longer between readings Continuous temperature monitoring can help manufacturers determine vaccine viability
bull Continue to encourage sites to document and evaluate minimum and maximum temperatures the storage unit reached since the last reading and respond appropriately to out-of-range temperatures
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The 2017 MnVFC Site Visit Paperwork Chapter 4
bull It is recommended that sites download and review data weekly Discuss with sites that reviewing temperature monitoring device data also includes responding appropriately if they identify out-of-range temps
bull There is sometimes confusion about the difference between a data logger and a continuous temperature monitoring system Here are some differences
Data Loggers Continuous Monitoring Systems Have an external display similar to thermometers May or may not have an external display Have a detachable probe Probe is usually attached to transmitter Need to be plugged into the computer or cradle to download information on a regular schedule
Wirelessly sends data to computer system
Create a file of data that needs to be saved on the computer
Data is stored within the system not a separate file
Doesnrsquot allow documentation of twice a day temperature checks in the file
May allow documentation of twice a day temperature checks within the system
More about the 2018 requirement for a continuous temperature monitoring device
Required Features bull The continuous temperature monitoring device must have Continuous monitoring and recording capabilities to track and record temperatures over time The capacity to routinely download temperature data to a computer (recommended at least weekly) or wirelessly transmit data Detachable probe in a bottle filled with a thermal buffer (eg bio-safe glycol) if the data logger needs to be detached in order to download data Active temperature display
Recommended Features bull MnVFC recommends continuous temperature monitoring devices with Alarm for out-of-range temperatures Accuracy within +-1degF (+- 05degC) Low battery indicator Display of current minimum and maximum temperatures Memory storage of at least 4000 readings User programmable logging intervals (eg the user can set how often the device records the temperature)
Note that these are all currently recommendations not requirements yet
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
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The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 45
Goal of this question Ensure the temperature monitoring device is properly calibrated The certificate of calibration testing means that the device has been tested and it is accurately measuring temperatures within established testing limits The certificate of calibration ensures that the device meets all the required components
Helpful information bull The provider is always responsible for having a current certificate of calibration (or copy) on-site
bull To be considered ldquovalidrdquo a certificate of calibration must contain these required elements Modeldevice name or number Serial number
4 Storage amp Handling Per Unit Certificate of Calibration Testing
Review CDC Requirement
Certificates of calibration testing provide confidence that the temperature monitoring device is measuring temperaturesaccurately All units storing VFC vaccines must have a calibrated temperature monitoring device with a current and valid certificateof calibration testing All certificates must contain modeldevice name or number serial number date of calibration testing (report or issue date) and Instrument Passed testingInstrument in Tolerance (Recommended uncertainty = +-05ordm C (+-1ordm F))
Question 45
Note to Reviewer
A
B
C
D
E
Review the certificate of calibration testing for the temperature monitoring device in this section of the storage unit and answer the questions below
bull How to determine certificate of calibration testing expiration date 1) Identify the certificate issuecalibration date 2) Apply the Immunization Program-required frequency for calibration testing Example If the
issuecalibration date is 12312013 and Immunization Program policy requires testing every twoyears the expiration date is 12312015
bull Certificates must include all of the below bull ModelDevice Name or Number bull Serial Number bull Date of Calibration Testing (Report or Issue Date) bull Instrument Passed testing (Instrument in Tolerance)
Is there a certificate of calibration testing for the temperature monitoring Yes device in this section of the storage unit No [X]
What is the date of calibration for the temperature monitoring device in this section of the storage unit
What is the certificatersquos date of expiration based on ImmunizationProgram policy (See note to reviewer to determine expiration date) [X] Follow-up is required if
certificate is expired
Does the certificate contain all the necessary items listed in the Note to Yes Reviewer No [X]
Who is responsible for supplying the current and valid certificate of Provider calibration for this temperature monitoring device
Date of calibration testing (report or issue date) Note If there is no expiration date the certificate expires 2 years from the date of calibration Whether the instrument passed or failed testing (or instrument in tolerancenot in tolerance)
bull Recommended element Documented uncertainty of +- 1degF [05degC]
If these elements are present the certificate is considered valid If the certificate contains information about the recommended element or the entity that issued the certificate that is helpful but not required
To determine if a certificate of calibration testing was issued by an appropriate entity check to see if the certificate indicates one or more of these items (this is the wording used to help sites evaluate if their calibration is accurate but is not required on the certificate itself to be considered valid)
bull Conforms to ISO 17025 bull Performed by an ILACMRA Signatory body accredited laboratory You can review this list of the ILAC MRA and Signatories (httpilacorgilac-mra-and-signatories)
bull Traceable to the standards maintained by NIST bull Meets specifications and testing requirements for the American Society for Testing and Materials (ASTM) Standard E2877 tolerance Class F (le 05 degC) or better
bull Includes reference to another acceptable accuracy validation method such as comparison to other traceable reference standards or tests at thermometric fixed points
Note CDC recommends that certifications be issued for the entire monitoring unit (detachable probe data logger etc) and not individual certificates for each component
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The 2017 MnVFC Site Visit Paperwork Chapter 4
For 45 E the provider is always responsible for supplying the current and valid certificate of calibration for a temperature monitoring device
bull Tip If the temperature monitoring device has a sticker on the back with the calibration date the site can usually call the company who calibrated the device and get a copy of the certificate if they donrsquot have one
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 46 4 Storage amp Handling Per Unit Probe Placement
Question 46 Is the probe properly placed in this section of the storage unit
Note to Reviewer ldquoProperlyrdquo means that the probe in a commercial or household unit is placed in a central area of the unitdirectly with the vaccines Probes should not be placed in the doors near or against the walls close to vents or on the floor of the unit The only allowable exemption related to this requirement is for providerswho have pharmaceutical storage units (built for vaccine storage) that have either (1) a built-intemperature monitoring device OR (2) a dedicated port for the probe that dictates the placement of theprobe
Answers (Choose one)
Yes No [X]
Review CDC Requirement
The probe must be placed in a central area of the section of the storage unit directly with the vaccines in order to properly measurevaccine temperature The probe should not be placed in the door near or against the walls close to vents or on the floor of theunit For pharmaceutical units with a built-in temperature monitoring device or a dedicated port for a probe that is not in thecenter of the section of the storage unit consult your Immunization Program for guidance on placement
Goal of this question Make sure the temperature monitoring device is in the best location to accurately measure the temperature of the vaccines stored in the unit
Helpful information bull The probe of the temperature monitoring device should be placed directly with the vaccines in the middle of the unit The ONLY allowable exception is for pharmaceutical storage units that have either a built-in thermometer or a dedicated port for the probe that indicates placement of the probe
bull Temperatures can vary within the unit especially household units bull Call MDH at 651-201-5522 if you have questions
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Guide (wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml)
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The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 474 Storage amp Handling Per Unit Temperature Documentation
Question 47 Review the temperature documentation over the past three months for this section of the storage unit todetermine whether the provider has a process in place for properly documenting temperatures twice aday Answer the questions below
A Are there two temperature readings recorded for this section of the storage unit per day
Yes No [X]
B Is there a time date and name (or initials) recorded for each reading Yes No [X]
C What is the current temperature and minmax temperatures (if available) inthis section of the storage unit Use the reviewerrsquos thermometer if the providerrsquos temperature monitoringdevice does not have a current valid certificate of calibration testing or the probe is not properly placed in this section of the storage unit
Current Temperature Minimum Temperature Maximum Temperature Fahrenheit Celsius
D Based on your review of the providerrsquos recent temperature documentationincluding the current temperature is this section of the storage unitmaintaining appropriate temperatures
Yes No [X] Not enough information [X]
Review CDC Requirement
Vaccines must be stored under appropriate temperatures as described in the package inserts at all times Acceptable temperature ranges vary by vaccine type and the range is 36deg F and 46deg F (2deg C and 8deg C) and for frozen vaccines the range is -58deg F and +5deg F (shy50deg C and -15deg C) Exposure to temperatures outside of those included in the package inserts could affect vaccine viability andultimately could leave children unprotected against vaccine-preventable diseases In order to maintain awareness of storage unittemperatures and ensure that vaccines are being stored at appropriate temperatures at all times VFC providers are required to monitor and document temperatures for all vaccine storage units at least twice a day Temperature documentation must contain (1) at least two temperature readings per day (2) the time and date of each reading and (3) the name (or initials) of the personwho assessed and recorded the readings CDC also recommends that VFC providers record the minimum and maximumtemperatures of each unit once each workday (preferably in the morning)
Goal of this question Ensure the temperature is being monitored twice daily is within the required range and documented correctly Use your thermometer to check the temperature if the sitersquos temperature monitoring devicersquos probe is not properly placed or there is not a current certificate of calibration Place your thermometer in the unit at the beginning of the visit to allow sufficient time to reach an accurate temperature The purpose of using your thermometer is to ensure the vaccine is being stored at the proper temperature not to ldquovalidaterdquo their reading
Question 47 D is an assessment question based on information you have learned during your visit You might answer ldquonot enough informationrdquo if the unit is new and they donrsquot have at least three months of data or if the unit is only used as overflow and they are inconsistent with temperature monitoring Mark ldquoNordquo if you have reason to believe the storage unit is not maintaining temperatures properly
Helpful information bull All sites must document temperatures twice a day every day the site is open even if they have a data logger or continuous monitoring system
bull Sites can document the information electronically with some continuous monitoring systems as long as it can show what the current temp is the date time and initials of the person checking ndash this needs to be someone at the site ndash not checking remotely or centrally for a large site or system The site must be able to produce these records during their site visit Reviewing these files can be a challenge due to large volumes and lots of paper
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Temperature Logs on Managing Vaccine (wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml)
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The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 484 Storage amp Handling Per Unit Temperature Excursions
Question 48 In the event that a temperature excursion(s) occurred in this unit within the last three months requestand review documentation of actions taken to determine whether the provider has a process for properlyaddressing excursions Answer the questions below
A Were vaccines in this unit exposed to out-of-range temperatures in the lastthree months (including today)
Yes No (If no skip to question 49)
B Did the provider quarantine and label vaccines as ldquoDo not userdquo Yes No [X]
C Did the provider place vaccine in a unit where it can be stored under properconditions if applicable
Yes No [X]
D Did the provider contact the Immunization Program to report theexcursion
Yes No [X]
E Was the manufacturer contacted for documentation supporting theusability of the vaccine
Yes No [X]
Review CDC Requirement
The provider must document all excursions and actions taken including the following (1) Quarantine and label vaccines as ldquoDO NOTUSErdquo (2) Place vaccines in a unit where they can be stored under proper conditions (3) Contact the Immunization Program to report an excursion and (4) Contact the vaccine manufacturer to obtain documentation supporting the usability of the vaccine
Goal of this question Address any out-of-range temperatures (temperature excursions) identified in reviewing the last three months of temperature logs or during the site visit If there were any out-of-range temperatures did the site respond appropriately to the situation This is a great opportunity to discuss what to do in the event of an excursion The Clinicians Storage and Handling Mishap Checklist is in the IPI Site Visit information folder and is a good review of the process
Helpful information bull Sites need to know that an excursion does not automatically mean that exposed vaccines are non-viable or unusable Exposed vaccines must be quarantined (marked ldquoDo Not Userdquo) and stored under proper conditions until they have received information from vaccine manufacturers regarding the viability of the vaccine
bull Sites must inform MDH when an excursion occurs
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Clinicians Storage and Handling Mishap Checklist (wwwhealthstatemnusdivsidepcimmunize ipivaxchklstpdf)
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The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 49
Goal of this question Ensure proper placement of vaccines in the storage unit
Note These are all recommendations (best practices) not requirements
Helpful information bull Store vaccine in the middle of the compartment two to three inches away from the coils walls floor and cold air vent The temperature near the floor and walls of the unit differs from that in the middle of the compartment and the cold air vent can freeze refrigerated vaccines
4 Storage amp Handling Per Unit Vaccine Placement
Question 49 Look inside the unit to answer the questions below
A Are vaccines placed in the middle of the unit with space between vaccinesand the sideback of the unit to allow cold air to circulate
Yes No [O]
B Are vaccines stored in their original packages Yes No [O]
C Are there water bottles (for refrigerators) or frozen water bottles (forfreezers) in the unit
Yes No [O]
D Are vaccines store in the doors vegetable bins under or near cooling ventsor on the floor of the unit
Yes [O] No
E Is food being stored in the unit Yes [O] No
Review CDC Recommendation
Vaccines should be stored in their original manufacturer (or CDC centralized distributor) packaging They should be placed in the middle of the unit with space between the vaccines and the sideback of the unit to allow cold air to circulate Vaccines SHOULD NOT be stored in the doors vegetable bins or floor of the unit or under or near cooling vents and there should not be any food inthe unit Water bottles (for refrigerators) or frozen water bottles (for freezers) should be placed throughout each storage unit inorder to (1) stabilize or extend temperatures during a power outage and (2) to serve as physical blocks preventing the placementof vaccines in areas of the unit that are at higher risk for temperature excursions (such as in doors vegetable bins floor ornearunder cooling vents)
bull Vaccines should be kept in their original packaging to Protect them from light Help prevent medication errors by making labels easier to read Provide a moisture barrier that serves as insulation in case of an out-of-range temperature power outage door left open or mechanical failure Simplify managing vaccine inventory
bull Store water bottles in the doors on the floor and near the cold air vent in the refrigerator and frozen water bottles in the freezer to help maintain a stable temperature if there is a power failure and when the door is opened frequently Too many water bottles in the door can prevent the door from closing tightly Mark water bottles ldquoDo Not Drinkrdquo
bull Do not store vaccine in the door or drawers of the refrigerator or freezer Vegetable bins and crisper drawers should be removed from refrigerators or used to store other medical supplies or water bottles
bull If vaccine is stored in a household combination refrigeratorfreezer The top shelf should not be used for storing vaccine because the cold air vent blowing from the freezer will freeze vaccine located there If you must use the top shelf of this type of unit place water bottles underneath the cold air vent to prevent vaccine from being stored there It is recommended that only the refrigerator be used for vaccine storage and a separate stand-alone freezer be used to store frozen vaccine
bull Must not store food or beverages in the refrigerator or freezer because frequent opening of doors can lead to temperature variations that may affect vaccine viability There is also a risk of contaminating vaccines
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Guide (wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml) bull Vaccine Storage Tip Sheet on IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml)
IPI Advisor Manual | February 2017 Page 41
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 4104 Storage amp Handling Per Unit Disconnection from Power Source
Question 410 Ask the provider to demonstrate what measures are taken to ensure that vaccine storage units are notaccidentally physically disconnected from the power supply Which of the following describes the measure(s) taken on this unit
Note to Reviewer bull Large hospitals and healthcare systems may not have the ability to demonstrate labels on plugs or circuitbreakers In such cases verify that the practice has a comprehensive policy and standard operatingprocedures in place to prevent the vaccine storage unit from being physically disconnected from thepower supply
bull While back-up generators may ensure power to the overall facility this question ONLY addresses thevaccine storage unit being accidentally disconnected from the power source either through the plug orthe circuit breaker
Answers A ldquoDo not disconnectrdquo labels on the plug (Choose all that B ldquoWarningrdquo label on the circuit breaker box
apply) C Hard-wired (ie built-in) and has a ldquoDo not disconnectrdquo label on thecircuit breaker box D Hospital or large health care system with a comprehensive written policyand standard operating procedures detailing measures taken to preventvaccine storage units from being accidentally disconnected from the powersupply E No acceptable measures for preventing accidental disconnection frompower supply [X]
[X] The response is non-compliant if only A only B or E is selected
Review CDC Requirement
VFC providers must take steps to protect the power source for all vaccine storage equipment by means of having clear warninglabels on both the plug and the circuit breaker associated with all vaccine storage units Large hospitals and healthcare systems canmeet this requirement by demonstrating that they have comprehensive policies and standard operating procedures to preventvaccine storage units from being physically disconnected from the power supply
Goal of this question Decrease the chance that a vaccine storage unit will be accidently unplugged or power will be turned off while vaccine is in the unit This question addresses only what measures the site has taken to ensure the storage unit is not physically disconnected from its power source
If the site uses labels on the plugs and circuit breakers perform a visual inspection to assess whether the way the stickers are positioned make it clear and obvious to anyone that these units are not to be disconnected
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Do Not Unplug and Warning stickers are included in the folder or available to order on the For
Professionals Order Form (wwwhealthstatemnusdivsidepcimmunizeordermathtml)
Note Once you have completed the 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet for each unit return to the questionnaire to complete sections 5 and 6
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The 2017 MnVFC Site Visit Paperwork Chapter 4
-
- -
Section 5 Storage amp Handling Site-Wide Question 51
5 Storage amp Handling Site Wide Discussion of Cost amp Quantity of Vaccine
Question 51 Have a discussion with the provider about the cost and quantity of VFC vaccines they are responsible for annually Address the points listed in the note to reviewer below
Note to Reviewer bull Vaccine Shipped (Required) Share the cost of VFC vaccines shipped to the provider in the last calendaryear to make sure the provider understands the contribution made by the VFC Program to their practiceFor new providers who do not have ldquocalendar yearrdquo data share either the actual cost of their currentinventory or use the cost of 10 VFC doses of each of the ACIP-recommended vaccines (approximately $7000) to help estimate their annual cost
bull Storage amp Handling (Required) Make sure the provider understands the cost of vaccines for which they are responsible when they make decisions about purchasing recommended vaccine storage and temperature monitoring equipment
Answer I have discussed with the provider the cost and quantity of vaccines ordered in the previous calendar year
Goal of this question Inform sites of the quantity and value of vaccines that they receive as part of the MnVFC program Providers often donrsquot realize the value of the vaccine in their unit This information is included on your clinic list and on the one page site-specific information
Helpful information bull This discussion must occur and the box on the questionnaire must be checked bull If there isnrsquot actual vaccine value information available tell the site that one vaccine order that includes a box of each of the ACIP recommended vaccines costs approximately $7000
bull MDH may not have specific information for individual sites if they receive vaccine from a central warehouse or pharmacy For those sites MDH will give you numbers for the whole system so you can discuss system wide data as appropriate If individual site information is also included it is usually just varicella-containing vaccines that must be shipped directly to the site
Question 52
5 Storage amp Handling Site Wide Dorm Style Units
Question 52 Determine whether the provider has any dorm-style units on site and answer the questions below
Note to Reviewer A dormitory-style refrigerator is a unit that has both refrigerator and freezer compartments behind a singleexterior door Dorm-style units also have an evaporator plate (cooling coil) which is usually located insidean icemaker compartment (freezer) within the refrigerator
A Does the provider have any dorm-style units that are used at any time tostore vaccines
Yes [X] No (Skip to question 53)
B Does the provider have sufficient space in existing compliant vaccinestorage units to store all vaccines without use of the dorm-style unit at any time
Yes No [X]
Review CDC Requirement
Dorm- and bar-style units are prohibited for vaccine storage Vaccines stored in dorm-style units are considered non-viable and must be returned to the centralized distributor CDC recommends the following vaccine storage unit types (in order of preference)pharmaceutical grade stand-alone or combination units (preferred) householdcommercial stand-alone unitshouseholdcommercial combination units using the refrigerator section only
Goal of this question Ensure no vaccine is stored in dorm-style units even for short periods of time Encourage them to label any units ldquoNo Vaccine Storage Allowedrdquo Vaccine stored in these units is considered non-viable If a site is using a dorm-style unit call the MnVFC program (651-201-5522)
Resource Section 8 in the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 43
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 535 Storage amp Handling Site Wide Storage Unit Space Availability
Question 53 Does the provider have sufficient room across storage units to store current stock as well as anyadditional stock acquired during peak season without overcrowding
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have sufficient storage space to accommodate vaccine stock at the busiest time of year without overcrowding
Goal of this question Ensure that sites have sufficient space in their units to maintain vaccines at the busiest time of year Overcrowding of vaccine limits air circulation and affects the unitrsquos ability to maintain stable temperatures
Helpful information bull Look for signs of overcrowding such as vaccines that are pushed up against the wall bins that are overflowing or storage units that are full during non-peak seasons
Discuss immediate actions if the unit is overcrowded Move some of their vaccines order less vaccine more frequently (once per month preferably) andor purchase another storage unit for overflow
Resource bull Section 8 MnVFC Policy and Procedure Manual
Page 44 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 545 Storage amp Handling Site Wide Expired Vaccines
Question 54 Look in each unit Are there expired vaccines in any of the vaccine storage units at this site
Answers (Choose one)
Yes [X] No
Review CDC Requirement
Vaccines should be rotated weekly and when a new shipment comes in so that longer-dated vaccines are stored behind shorter-dated vaccines If vaccines expire they can no longer be stored in the same storage unit with viable vaccines They must be placedin a container or bag clearly labeled ldquoDo not userdquo and separated from viable vaccines to prevent inadvertent use Expired vaccinemust be returned to the centralized distributor within six months of expiration
Goal of this question Ensure there is no expired vaccine in any storage unit
Helpful information bull Sites can prevent their stock from expiring by rotating vaccines every week andor when a new shipment arrives Longer-dated vaccines are stored towards the back of the unit and shorter-dated vaccines are up front
bull Pay attention to vaccines that expire within the next three months Consider transferring vaccine that will expire soon to another MnVFC-enrolled site that will use the vaccine preferably a site close by It is the transferring sitersquos responsibility to arrange the transfer of the vaccine Be sure to complete the MDH Vaccine Transfer Record form and send it to MDH If they are having difficulty finding a location to accept vaccine contact MDH
bull This is a great opportunity to educate sites about the MDH Nonviable Vaccine Form and the process for returning vaccine The VFC program does get some credit for taxes and fees on vaccine that is returned to the distribution center
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MDH Nonviable Vaccine Form and MDH Vaccine Transfer Record on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfcformshtml)
IPI Advisor Manual | February 2017 Page 45
The 2017 MnVFC Site Visit Paperwork Chapter 4
- -
-
Question 555 Storage amp Handling Site Wide Back up Thermometer
Question 55 Does the provider have a readily available back-up thermometer with a current and valid certificate ofcalibration testing
Note to Reviewer ldquoReadily availablerdquo means that the thermometer is available to perform twice-a-day monitoring for a unit asrequired CDC recommends that the back-up thermometer be maintained on site
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have a readily available back-up thermometer with a current and valid certificate of calibration testing Toprevent the certificates of calibration testing of the primary and back-up thermometers from expiring at the same time the date of calibration testing (or issue date) of the back-up thermometer should be different from the date of calibration testing (or issue date) of the primary thermometer As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meetsVFC program requirements
Goal of this question Ensure sites have one calibrated back-up thermometer onsite that is readily available in the event that the temperature monitoring device in unit fails transportation of vaccine is needed or there are other unexpected circumstances
Helpful information bull As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meets VFC Program requirements
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 56 5 Storage amp Handling Site Wide Preparation of Vaccine
Question 56 When does this provider prepare vaccine for administration to the patient
Note to Reviewer For mass vaccination clinics if one type of vaccine is offered providers may pre-draw up to 10 doses Ifusing pre-filled syringes pre-drawing also means activating the syringe by removing the needle guard orattaching a needle
Answers (Choose all that
apply)
Prepare dose immediately before administration Pre-draw doses for upcoming patients (in a regular clinicpractice) [O] Pre-draw up to 10 doses (in a mass-vaccination clinic) Pre-draw more than 10 doses (in a mass-vaccination clinic) [O] Other [O]
Review CDC Recommendation
CDC recommends preparing vaccines immediately prior to administration in order to assure viability of vaccine and prevent vaccinewastage Vaccines that are not administered immediately are at risk of exposure to temperatures outside of the required rangewhich can affect vaccine viability and ultimately can leave children unprotected against vaccine-preventable diseases
Goal of this question Discuss proper timing and preparation of vaccine(s) for administration These are recommendations not requirements
Helpful information bull Educate staff on the importance of preparing vaccine immediately before administration Pre-drawing of vaccines may lead to concerns related to vaccine viability potency sterility and wastage
Page 46 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 6 Inventory Question 61
6 Inventory Inventory Comparison
Question 61 Visually inspect storage units to determine if existing supply of vaccines proportionately mirrorspopulations served Choose the most accurate statement below
Note to Reviewer bull CDC recommends that providers maintain a four-week supply of inventory bull For this question do not take into account vaccine types that the provider does not order Here simply
make sure that overall the vaccines in the providerrsquos storage units are available in sufficient amounts toserve their patient population
Answers (Choose one)
The current vaccine inventory proportionately reflects the populations identified Only public stock is insufficient [X] Only private stock is insufficient [X] Both public and private stock are insufficient [X] Site uses the replacement method but does not appear to have enough vaccine for their population [X] Other [X]
Review CDC Requirement
VFC providers must order and stock routine vaccines in accordance with their patient population in order to prevent missedvaccination opportunities Having sufficient amounts of all stocks prevents the inadvertent use of VFC vaccines for non-VFC-eligiblepatients and vice versa
Goal of this question Assess whether the site is ordering appropriate quantities of vaccine for the population they serve at their site
Helpful information bull If the site sees 30 percent private-pay patients and 70 percent VFC the stock in their storage units should reflect that proportion If you donrsquot know you can ask the site about their population
bull This is meant to be a general assessment so in a big site if they have only a small amount of vaccine that may indicate an issue with vaccine management
bull CDC recommends smaller more frequent orders (ie monthly) rather than large orders to minimize the amount of vaccine loss if an incident occurs during shipment or in the storage unit Sites should not order more frequently than once a month
bull Sites using the replacement method will only have one stock but it should appear to be large enough for their population
bull Only assess the vaccine types that the site currently stocks in their unit We know there are sites that do not offer all ACIP-recommended vaccines for various reasons That issue will be addressed in question 62
IPI Advisor Manual | February 2017 Page 47
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 626 Inventory ACIP Recommended Vaccines
Question 62 Review providerrsquos current inventory to answer the questions below
A Does the provider offer all routine ACIP-recommendedvaccines for their patient population
Yes (Skip to question C) No [X] Offers all except varicella because direct ship ofvaccine is unavailable from manufacturer
B Which routine vaccines are NOT being offered DTaP Hepatitis A Hepatitis B HIB HPV Influenza Meningococcal
MMR Pneumococcal Polio Rotavirus TdapTd Varicella
C According to Immunization Program Policy does theprovider make accessible all non-routine ACIP-recommended vaccines for those VFC patients whomeet the criteria for receiving them
Yes (Skip to question 63) No [X]
D Which non-routine vaccines are NOT being offered Pneumococcal polysaccharide vaccine (PPSV23) Meningococcal Group B (MenB) Other
Review CDC Requirement
VFC providers agree to comply with immunization schedules dosages and contraindications that are established by the Advisory Committee on Immunization Practices (ACIP) for the vaccines identified and agreed upon in the Provider Agreement UNLESS bull In the VFC providers medical judgment and in accordance with accepted medical practice the VFC provider deems such
compliance to be medically inappropriate for the child bull The particular requirements contradict state law including laws pertaining to religious and other exemptions The VFC program entitles children to the following vaccines DTaP Hepatitis A Hepatitis B HIB HPV Influenza MeningococcalMMR Pneumococcal Polio Rotavirus TdapTd and Varicella VFC providers are also required to ensure that VFC-eligible children have access to non-routine vaccines as needed
Goal of this question Assess if the site is offering all the ACIP-recommended vaccines for the population they serve and these vaccines are in stock on the day of the visit It is important that every MnVFC-eligible child that comes to a providerrsquos office for an immunization is vaccinated
Helpful information bull The Advisory Committee on Immunization Practices (ACIP) is a group of medical and public health experts that develops recommendations on how to use vaccines to control diseases in the United States
bull Specialty providers are not required to offer all routine vaccines but should provide the vaccines appropriate for their population
bull If the site does not offer all routine ACIP-recommended vaccines appropriate for their population check the ldquoNordquo box in Part A then check the appropriate box(es) in Part B for any vaccines not offered Please contact MDH as this situation offers us the opportunity to provide education to the site
bull For non-routine vaccines they must either be in stock or the site must have an alternative protocol in the routine management plan that ensures these children have access when applicable
Resources bull IAC Diseases and Vaccines (wwwimmunizeorgvaccines) bull CDC Advisory Committee on Immunization Practices (ACIP) (wwwcdcgovvaccinesacipindexhtml)
Page 48 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 636 Inventory Separation of Stock
Question 63 Observe how the provider differentiates stock in each storage unit to answer the questions below
A Is it clear which vaccines belong to public stock andwhich belong to private stock
Yes No [X] Not applicable replacement site
B Is it clear which vaccines belong to VFC stock andwhich belong to UUAV stock
Yes No [X] Not applicable replacement site Not applicable not UUAV-enrolled site
Review CDC Requirement
In order to ensure that VFC vaccines are only administered to VFC-eligible children VFC providers that serve both VFC and non-VFCshyeligible children must maintain their vaccine inventories in such a way that they can clearly differentiate public stock from privatestock as well as VFC from other public stock
Goal of this question Assess whether the site can distinguish between MnVFC vaccine and private vaccine If they participate in the Uninsured and Underinsured Adult Vaccine (UUAV) program they should also be able to distinguish between MnVFC stock and UUAV stock Some sites use labels bins boxes etc to differentiate their stock If it is not clear how the site differentiates their stock discuss vaccine management with the staff For follow-up call MDH to discuss doing a follow-up site visit
Sites using the replacement method will not have separate stocksmdashthis is an approved alternative method for keeping track of vaccine
Resource bull Section 10 of the MnVFC Policy and Procedure Manual
IPI Advisor Manual | February 2017 Page 49
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
MnVFC Site Visit Storage and Handling Per Unit Answer Sheet 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet MnVFC PIN ___________________
Question number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
Temperature Monitoring Device Questions Questions 43 47 must be answered separately for the freezer and refrigerator if the unit is a combo Be sure to document responses in the appropriate column
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
All the questions on the Site Visit Storage amp Handling Per Unit Answer Sheet have been discussed previously in section 4 of this manual Use this sheet to record information about all the units at the site visit You will need one sheet for each unit If it is a combination unit (either pharmaceutical or household) you can record both sections on one sheet If they have stand-alone units use one sheet for each unit Do not enter the answers to the questions in section 4 of the questionnaire
If you need more information about any of the questions refer back to the main questionnairemdashthe complete question additional guidance including notes to the reviewer and the CDC requirements are there Also if the site is not meeting the requirement you will go back to the questionnaire to complete the ldquoActions if Non-compliantrdquo section including the root cause analysis and follow-up sections
When you have completed the assessment of all the storage units remember to go back to the questionnaire to complete sections 5 and 6
Page 50 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
ndash
ndash
MnVFC Provider Follow-up PlanThe goal of the Provider Follow-up Plan is to communicate with the site all of the VFC requirements any unmet requirements found during your site visit and the timeline for completing the required action The left hand column is a box to check for ldquoUnmetrdquo requirements
Helpful information bull The form can be used to review what the site is doing well and what they need to work on
bull For requirements that have specific documentation that needs to be sent to you use the notes section
2017 MnVFC Provider Follow-up Plan Site _______________________________________________ MnVFC PIN ____________ Date of Visit ___________
Thank you for participating in this MnVFC compliance site visit Please review this visit summary including follow-up actions and timelines for completion Unmet MnVFC requirements and recommendations have a checked box next to them The goal of this plan is to support you with successfully implementing the program and improving access to vaccines for VFC-eligible children
Unmet Question VFC Requirements Section 1 Changes to Key Staff
Q12 Change in the Medical Director Immunization Manager Vaccine Coordinator or back-upKey Staff must be communicated to the immunization program by emailing healthmnvfcstatemnus Changes Notes
Q12 Key staff must complete the annual training on VFC program requirements and print theAnnual Training certificate of completion Documentation Required Action
Staff that have not completed the MnVFC online training must complete it and send acopy of the certificate to the reviewer Training can be found on the MnVFC website (wwwhealthstatemnusvfc) Due date 1 month
Notes
Unmet Question VFC Requirements Section 2 Eligibility
Q21 Provider staff must possess a working knowledge of all VFC eligibility criteria and use thoseVFC Eligibility criteria to screen children prior to administering VFC vaccines
Categories Notes
bull This form provides documentation needed for follow-up actions when you send your thank you email
The second to last page of the Provider Follow-up Plan has a summary of the MnVFC program recommendations These are to remind the site about best practices they may want to improve upon even though they are not yet requirements of the program For example you could discuss the recommendation about storage units if they currently have a combination household unit and are using both sections
The last section is for your signature and the person you met with In most sites it will be the immunization manager or vaccine coordinator who signs the form unless the medical director attended the site visit You keep the original copy and the site will need to keep a copy for themselves
To be completed by the site visit reviewer
I acknowledge that a VFC site visit was performed on __________________ (visit date) The follow-up plan which includes a list of all current VFC program requirements and recommendations assessed during the visit and any required follow-up actions was provided at the end of the visit
Site visit reviewer
Phone
Reviewer Signature Date
To be completed by the provider
I acknowledge that our practice took part in the VFC site visit noted above I understand the findings of the visit and any required actions that must be taken by our office in order to meet VFC program requirements
Medical Director (or designee) Name Title
Medical Director (or designee) Signature Date
IPI Advisor Manual | February 2017 Page 51
The 2017 MnVFC Site Visit Paperwork Chapter 4
After the Site Visit Send a thank you email highlighting the unmet requirements documents you need from the site to resolve the issue(s) and the date you need them Make sure to include the link to the Site Visit Survey (httpssurveyvovicicomseashxs=56206EE334CE0B14)
Please refer to Chapter 3 for more information about future follow-up required after the visit including forms and documentation
Resource bull Sample Thank You letter on IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml)
Chapter 5
IPI Advisor Resource List MnVFC Program 651-201-5522
MnVFC wwwhealthstatemnusvfc
bull Separate Stock and Replacement Method Policies and Procedures Manuals bull Online trainings bull MnVFC Announcements sign up to receive them via email bull Ordering MDH vaccine bull MnVFC forms Screening forms Reporting forms Others MDH Nonviable Vaccine Form MDH Vaccine Transfer Record and Vaccine Borrowing Report
bull MnVFC promotional materials bull Immunization Billing Guidance for MnVFC and Immunization Billing Guidance for MnVFC Replacement Sites Immunization Practices Improvement Program (IPI) wwwhealthstatemnusdivsidepcimmunizeipi
bull IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml) bull IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml) IPI Resource Folder Contents (wwwhealthstatemnusdivsidepcimmunizeipiipifolderpdf)
Minnesota Immunization Information Connection (MIIC) wwwhealthstatemnusmiic
bull MIIC regions and regional coordinators
Clinical Practice MDH Immunization Program wwwhealthstatemnusimmunize
Got Your Shots News wwwhealthstatemnusdivsidepcnewslettersgys
MDH Immunization Information for Health Care Providers wwwhealthstatemnusdivsidepcimmunizehcp
bull Got Your Shots A Providers Guide to Immunization in Minnesota bull Vaccine protocols bull Forms for tracking patient immunizations bull Immunization schedules for Health Care Providers Immunization Action Coalition (IAC) wwwimmunizeorg
bull Ask the Experts bull VISs (Vaccine Information Statements and translations) bull Administration screening questions bull Medical management of vaccine reactions bull Order form for Californiarsquos Immunization Technique DVD Best Practices with Infants Children and Adults
Page 52 IPI Advisor Manual| February 2017
IPI Advisor Resource List Chapter 5
CDC ldquoPink Bookrdquo wwwcdcgovvaccinespubspinkbookindexhtml
CDC Advisory Committee on Immunization Practices (ACIP) wwwcdcgovvaccinesacip
CDC Vaccines and Immunizations wwwcdcgovvaccines
VAERS reporting httpvaershhsgovindex
Storage and Handling Got Your Shots Providers Guide ndash Managing Vaccine wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml
MnVFC Guide to Temperature Monitoring Devices wwwhealthstatemnusvfc
MDH Clinicianrsquos Vaccine Mishap Checklist wwwhealthstatemnusdivsidepcimmunizeipivaxchklstpdf
MDH Vaccine Storage Guide wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml
CDC Vaccine Storage and Handling Toolkit wwwcdcgovvaccinesrecsstoragetoolkit
You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Vaccine manufacturer phone numbers wwwcdcgovvaccinespubspinkbookdownloadsappendicesFcontact-info-manufactpdf
IAC Checklist for Safe Vaccine Handling and Storage wwwimmunizeorgcatgdp3035pdf
IAC Donrsquot Be Guilty of These Errors in Vaccine Storage and Handling wwwimmunizeorgcatgdp3036pdf
Additional Resources Print materials from MDH ndash order forms wwwhealthstatemnusdivsidepcimmunizeordermathtml
Vaccine Education Center ndash Childrenrsquos Hospital of Philadelphia wwwchopeduservicevaccine-education-centerhomehtml
California Department of Public Health ndash Interactive training on vaccine administration and storage and handling handout on transporting vaccine and how to package wwwezizorg
IPI Advisor Manual | February 2017 Page 53
IPI Advisor Resource List Chapter 5
CDC vaccine price list wwwcdcgovvaccinesprogramsvfcawardeesvaccine-managementprice-listindexhtml
Vaccine Information Statements (VIS) wwwcdcgovvaccineshcpvisindexhtml
CEU Opportunities CDC Immunization Education and Training wwwcdcgovvaccinesedindexhtml
Immunization You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Page 54 IPI Advisor Manual| February 2017
- Introduction
-
- Welcome to the Immunization Practice Improvement (IPI) Program
- Contact Information
-
- Chapter 1
- Requirements to Participate in the MnVFC Program
- Vaccines for Children Program
- Chapter 2
- Reimbursement for MnVFC Visits
- Types of Visits
- Your MnVFC Clinical CoordinatorPlanner
- New IPI Advisor Training Requirements
- Your Role as an IPI Advisor
- Reasons MDH Would Do All or Part of a Visit
- Chapter 3
- Future follow-up
- Conducting the Visit
- Preparing for the Visit
- Information for the Visit
- Site Visit Checklist
- Scheduling the Visit
- Chapter 4
- After the Site Visit
- MnVFC Provider Follow-up Plan
- MnVFC Site Visit Storage and Handling Per Unit Answer Sheet
- Section 6 Inventory
- Section 5 Storage amp Handling Site-Wide
- Section 4 Storage amp Handling Per Unit
- Section 3 Documentation
- Section 2 Eligibility
- Section 1 Provider Details
- The Site Visit Reviewer Legend
- MnVFC Site Visit Questionnaire
- Required Paperwork for Site Visits
- Chapter 5
-
Site Visits Chapter 3
Future follow-up Follow-up is an important component of the site visit It helps us ensure that the unmet requirements have been corrected The questionnaire has different time periods for follow-up depending on the question Do not wait to complete your follow-up before submitting the site visit paperwork
When you complete the Follow-Up Form make sure to keep a copy for yourself MDH also keeps track of follow-up required and will remind you if follow-up has not been completed by the deadline Most follow-up can be done with a phone call or email In-person follow-up is rarely required and should be discussed with MDH before scheduling a follow-up visit
All requirements that need follow-up are identified with a [X] on the site visit paperwork and are listed on the MnVFC Provider Follow-up Plan
bull Follow-up with the site to see how they have resolved the unmet requirements bull Document your follow-up on the Follow-Up Form available on the IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml) page If follow-up was done via letter or email a copy can be attached to the Follow-Up Form
bull Send your Follow-Up Form to MDH (healthIPIinquiriesstatemnus) with supporting documents and emails
bull If a site is not responding to your requests regarding follow-up contact your MnVFC clinical coordinatorplanner They can help with additional follow-up as needed
Page 16 IPI Advisor Manual | February 2017
Chapter 4 The 2017 MnVFC Site Visit Paperwork This chapter will go through the required MnVFC site visit paperwork with notes about information or resources to help the site address questions or issues that may arise during the visit
The MnVFC site visit paperwork is available on the IPI Advisor Site Visit Materials (wwwhealthstate mnusdivsidepcimmunizeipisvmaterialshtml) page
Please download the paperwork shortly before your visit as there may be updates and changes and this will be the most up-to-date version of the questionnaire We will send out a Workspace message with major changes
Required Paperwork for Site Visits bull 2017 MnVFC Site Visit Questionnaire bull 2017 MnVFC Storage amp Handling Per Unit Answer Sheet ndash one for each unit assessed during site
visit bull 2017 MnVFC Provider Follow-up Plan ndash with provider signature
Make sure to include the sitersquos PIN on all your paperwork Please complete and submit your site visit paperwork as soon as possible after your visit It may be helpful to schedule some time into your calendar to complete your paperwork in the days following your visit Once you have completed the post-visit follow-up send in the Follow-Up Form with documentation of the follow-up actions Please do not wait until you have completed your follow-up before sending in your initial paperwork
MnVFC Site Visit Questionnaire The questionnaire includes these six sections 1 Provider details 2 Eligibility 3 Documentation 4 Storage amp handling per unit 5 Storage amp handling site-wide 6 Inventory
IPI Advisor Manual | February 2017 Page 17
Page 18 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
The Site Visit Reviewer Legend The legend explains the formatting of the 2017 questionnaire This includes information that will be helpful in completing the site visit
Site Visit Reviewer Guide Legend
Section Number Content Area
Question number This area will always contain the text of the question
Note to reviewer The note to reviewer contains information that is necessary for properly asking and assessing responses tothe question above This may include definitions of terms requirement details and other helpful tips
Answers This field will contain all the possible answer choices for this question For most questions answer choiceswill be followed by the markings below
Answer choices marked with an [X] indicate that this specific answer choice is non-compliant with a CDC requirement Answer choices marked with an [O] indicate that this specific answer choice is not aligned with a CDC
recommendation
Review CDC RequirementRecommendation
This field will be populated with the CDC requirementrecommendation associated with the given question
Actions if Non-Compliant
Root Cause Analysis As part of the site visit reviewers are required to assess and understand the reasons why a provider office isnon-compliant with VFC program requirements ndash this is a root cause analysis Reviewers must choose theone root cause that they believe most contributes to the non-compliance Upon establishing the root causethe reviewer must provide a clear explanation of hisher findings
Immediate Action These are actions that CDC requires reviewers to take on site during the visit
Future Follow-up These are future follow-up actions (with designated due dates) that are required of the reviewer andorprovider to remedy non-compliance Reviewers must complete all follow-up in accordance with CDCestablished deadlines
Notes Information you want the VFC program to be aware of or that explains your answer in detail
bull Note to reviewer These are notes to help you understand what the question is asking for and to clarify things you might want to know when asking or rephrasing the question
bull Answers This section helps you to know when the answer does not meet the CDC requirement [X] or recommendation [O] Whenever an answer with a [X] is checked the ldquoActions if Non-compliant section must be completed The recommendations are usually good teaching points about best practices andor future requirements of the VFC program
bull Review the CDC RequirementRecommendation This section provides a specific outline of the requirement or recommendation to give you information to use in talking with the site staff
bull Actions if Non-Compliant This section describes what to do if the site is not meeting a requirement Root cause analysis This section asks you to probe beyond the surface to find what is driving the non-compliance It is intended to help uncover reasons for recurring non-compliance issues identify additional training needs and inform reviewer follow-up actions Select only one root cause and explain the particular circumstances in the space ldquoExplanation of root causerdquo line provided If there appear to be multiple issues choose the one that most contributes to the non-compliance and describe all factors in the explanation Immediate actions A list of actions to take during the site visit to address the issue Future follow-up A list of actions to take after the site visit by the set deadline
bull Notes This section can be used for notes to yourself or to MDH
IPI Advisor Manual | February 2017 Page 19
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 1 Provider Details Questionnaire Coversheet
The first page of the questionnaire collects the demographic information for the site You can use this page to help prepare for the visit Most of the demographic information about the site should be on the site-specific document you received with your clinic list You will validate that this information is current at the time of the site visit It also helps to know if this is a separate stock site or a replacement site before the visit so you can bring a copy of the appropriate MnVFC Policies and Procedure Manual
2017 MnVFC Site Visit Questionnaire Date of visit _____________ Date forms sent to MDH ______________
Site Information
Site name MnVFC PIN
Address Separate Stock Replacement
City ZIP County
Medical Director Email
Immunization Manager Phone
Vaccine Coordinator Phone
Vaccine Coordinator back-up Email
Point of contact Phone
Personnel at site visit
On this page bull The date of the visit and the date when you send these forms to MDH This information helps us track the timeliness of our review and data entry process
bull The vaccine management method used by the site (replacement or separate stock) bull The name and email of the medical director (ideally this is the person who signed the MnVFC
Program Provider Agreement)bull Contact information for the immunization manager vaccine coordinator vaccine coordinator back-up and point-of-contact for this visit The immunization manager vaccine coordinator vaccine coordinator back-up roles are
described in the MnVFC Policies and Procedure Manual The vaccine coordinator back-up may be the immunization manager or another staff person depending on the size of the site and available personnel The Point of Contact is the person you set up the appointment with signs the Provider Follow-
up Plan and receives the follow-up email This may be one of the people listed above
The Post Visit Steps section is a reminder to you about what needs to done after the visit The Education on Immunization Best Practices for Sites section reminds you to provide the resource folder to the site
Page 20 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 12
1 Provider Details Changes to Key Staff
Question 12 Ask the provider about changes to key staff to answer the questions below
A (Choose all that
apply)
At the time of the visit is the Medical Director the same individual that signed the ProviderAgreement and are the Immunization Manager and Vaccine Coordinator the same asthose last reported to the program
Yes No the Medical Director has changed No the Immunization Manager has changed No the Vaccine Coordinator has changed
B (Choose one)
Were all changes communicated to theImmunization Program according to yourprogramrsquos policy
Yes or no staff changes No [X]
C (Choose one)
Based on review of the trainingdocumentation have the current Immunization Manager Vaccine Coordinator and back-up completed all required training
Yes No [X]
Review CDC Requirement
All changes in key staff must be communicated to the Immunization Program in the manner and timeframe defined by theImmunization Program Key staff include the Medical Director or equivalent who signed the Provider Agreement the Immunization Manager Vaccine Coordinator and the back-up VFC providers are required to ensure that all key staff are fully trained on VFC program requirements at all times All training must be documented
Goal of this question Determine if there are new staff in key positions at the site and to make sure staff are properly educated about the MnVFC program A This information can help you determine the level of knowledge and experience the staff have with the MnVFC program Follow-up throughout the visit can be tailored for various levels of staff experience Likewise you may identify additional training needs for new staff
B When sites notify us of changes in key personnel we update their information in MIIC and on the clinic lists We also send the new staff information for completing the online training and direct them to read the appropriate MnVFC Policies and Procedures Manual If the answer to this part is no update the demographic area of the questionnaire and inform the staff that in the future they must notify the MnVFC program (via email or phone) if the immunization manager or vaccine coordinator changes Resource Section 12 of the MnVFC Policies and Procedures Manual
C Annual training must be verified by looking at the certificates for the online training If the answer to this part is no refer the staff to complete the appropriate MnVFC online training found on the MnVFC website (wwwhealthstatemnusvfc) for their program (separate stockreplacement) for the current year and send you a copy of the certificate within 30 days
Resource bull Sections 12 and 14 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 21
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 2 Eligibility Question 21
Goal of this Question Assess whether staff correctly understand which patients are eligible for the MnVFC program Screening ensures that eligible children receive the vaccines that they are entitled to receive under the MnVFC program and helps to prevent fraud or abuse of the program
Children 18 years and younger in these
categories can receive MnVFC vaccine at any enrolled site bull Uninsured bull Enrolled in a Minnesota Health Care Program (MHCP) Medical Assistance (MA) or MinnesotaCare bull American Indian or Alaskan Native
The following categories are considered underinsured and are only MnVFC-eligible at local public health (LPH) Federally Qualified Health Centers (FQHC) Rural Health Centers (RHC) Indian Health Services (IHS) and tribal health clinics
bull Has health insurance that does not cover one or more vaccines as can be the case with newly licensed vaccines that arenrsquot yet covered (MnVFC-eligible for non-covered vaccines only)
bull Has health insurance that caps vaccine coverage at a certain amount Once that amount is reached the child is MnVFC-eligible
Children with insurance that does not cover vaccines until a deductible has been met are considered to be fully insured and are not MnVFC-eligible
Helpful information bull Sites are not required to verify the patientrsquos response to the screening questions For example if a patient states they lost their insurance the site does not need to call the patientrsquos insurance company to confirm
If the site cannot correctly describe the eligibility categories provide educational materialsresources on MnVFC eligibility requirements
Resources bull Patient Eligibility Screening Record on MnVFC Forms (wwwhealthstatemnusdivsidepc immunizemnvfcformshtml)
bull Section 1 of the MnVFC Policies and Procedures Manual
2 Eligibility VFC Eligibility Categories
Question 21 Was the individual responsible for determining patient VFC eligibility able to explain all the factors(including age) that make a child eligible to receive VFC vaccines
A Patient is less than 19 years of age Yes No [X]
B Patient is Medicaid-eligible Yes No [X]
C Patient is uninsured Yes No [X]
D Patient is underinsured Yes No [X]
E Patient is American Indian Yes No [X]
F Patient is Alaska Native Yes No [X]
Review CDC Requirement
VFC providers must possess a working knowledge of all VFC eligibility criteria and use those criteria to screen children prior toadministering VFC vaccines In order to receive VFC vaccine a patient must be under the age of 19 and must be at least one of the following (1) Medicaid-eligible (2) Uninsured (ie child has no health insurance) (3) Underinsured (ie child has health insurancebut coverage does not cover any or certain vaccines ndash underinsured children may only receive VFC vaccines in FQHCRHC ordeputized VFC provider offices and only for vaccines not covered by insurance) and (4) American Indian or Alaska Native (AIAN)
Page 22 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 22
2 Eligibility Billing Practices
Question 22 Is the individualdepartment responsible for billing able to clearly explain how they bill for both the costof vaccine and the vaccine administration fee for each of the eligibility categories below
A Medicaid-eligible Cost of Vaccine Do not bill ndash provided by VFC Admin Fee Bill Medicaid
Yes No [X]
B Uninsured Cost of Vaccine Do not bill ndash provided by VFC Admin Fee If billing can bill patient
Yes No [X]
C Underinsured Cost of Vaccine Do not bill ndash provided by VFC through FQHCsRHCs or deputized providers only all other providers cannotprovide VFC vaccine to underinsured patients Admin Fee If billing can bill patient
Yes No [X]
D American IndianAlaska Native(AIAN)
Cost of Vaccine Do not bill - provided by VFC unless patient is fully insured and parent chooses to use insurance Admin Fee If patient is Medicaid-eligible bill Medicaid if billingand patient is uninsuredunderinsured can bill patient if parentchooses to use private insurance for cost of vaccine billpatientinsurance
Yes No [X]
E Do individuals responsible for billing have access to the results of eligibility screening toensure proper billing
Yes No [X]
Review CDC Requirement
VFC providers must adhere to proper billing practices for vaccine administration fees and clearly understand that VFC vaccine isprovided at no cost to both the VFC provider and eligible children At no time should billing occur for the cost of VFC vaccine Whenadministering VFC vaccine providers should never bill two different ldquopayersrdquo (ie patient Medicaid insurance) for the samevaccine administration fee amount For Medicaid-eligible children Medicaid should be billed for the vaccine administration fee Forall other VFC-eligible populations the patient may be billed within the stateterritory cap established by the Centers for Medicareand Medicaid (CMS) However patients cannot be turned away or reported to collections for inability to pay the administration fee
Goal of this question Determine if the staff correctly understand how to bill patients that are eligible for the MnVFC program Billing appropriately ensures that children can receive low cost immunizations and the site is in compliance with the VFC program
bull If there is any indication that sites could be billing insurance companies or parents for VFC vaccines this should be investigated further
bull Most sites in Minnesota will bill Medicaid with the SL modifier ndash which indicates this is a Medicaid claim
bull The main point is to ensure the site is not billing uninsured children for VFC vaccine and are not charging them more than $2122 per vaccine for the administration fee
bull Non-compliance is usually unintentional and may be resolved with some training In rare cases it could be a glimpse into a larger problem where a site is intentionally billing for financial gain
bull If you think the site is billing inappropriately it is the responsibility of the IPI advisor to report concerns to MDH staff for further assistance
Resources bull Immunization Billing Guidance for MnVFC (wwwhealthstatemnusdivsidepcimmunizemnvfc billingtipshtml) or Immunization Billing Guidance for MnVFC Replacement Method Sites (www healthstatemnusdivsidepcimmunizemnvfcreplacementbillingtipsrephtml)
bull Section 2 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 23
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 232 Eligibility Vaccine Administration Fee
Question 23 Document the actual vaccine administration fee charged to non-Medicaid VFC-eligible patients (confirmwith billing department)
Answers Fee $ [X] Follow-up is required if the provider charges more than the fee cap establishedby the Centers for Medicare and Medicaid (CMS) for your stateterritory ($2122)
Review CDC Requirement
The VFC providerrsquos vaccine administration fee for non-Medicaid VFC-eligible children must not exceed the stateterritory vaccineadministration fee cap established by the Centers for Medicare and Medicaid (CMS) For current fee caps refer to Medicaid Program Payments for Services Furnished by Certain Primary Care Physicians and Charges for Vaccine Administration Under theVaccines for Children Program Final Rule (httpwwwgpogovfdsyspkgFR-2012-11-06pdf2012-26507pdf)
Goal of this question Ensure that sites are not charging more than the federal allowable vaccine administration fee of $2122
bull The Centers for Medicaid and Medicare (CMS) establishes a maximum fee that sites can charge to non-Medicaid-eligible VFC patients in each stateterritory for vaccine administration Health Plans usually negotiate this fee with the site but Medicaid will not pay more
bull If a parent cannot pay the vaccine administration fee the patient cannot be turned away or reported to collections VFC-eligible children must be vaccinated regardless of their ability to pay
bull If the person with whom you are conducting the site visit does not know the exact fee charged to non-Medicaid VFC-eligible patients ask to speak to someone who can verify the exact amount
bull If they are charging more than $2122 for the administration fee ndash please contact MDH staff for help with addressing this situation
Resources bull Immunization Billing Guidance for MnVFC (wwwhealthstatemnusdivsidepcimmunizemnvfc billingtipshtml) or Immunization Billing Guidance for MnVFC Replacement Method Sites (www healthstatemnusdivsidepcimmunizemnvfcreplacementbillingtipsrephtml)
bull Section 2 of the MnVFC Policies and Procedures Manual
Page 24 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 3 Documentation Question 31
3 Documentation Eligibility Screening amp Documentation
Question 31 To answer the questions below the provider must clearly demonstrate the patient intake processReview a minimum of 10 records that contain an immunization visit within the last 6 ndash 12 months
Note to Reviewer Criteria for Record Selection 1) Record selection must be completely random and the provider must not know prior to the visit which
records will be reviewed 2) Patient must have been 0-19 years of age at the last visit (Note Records of 19-year-old patients may
allow you to see if VFC vaccines are being used beyond the allowable age) 3) Must review a mix of public and private-pay patients (if applicable)
A Does the provider have a process that ensures that patients are screened forVFC eligibility at each visit and that screening results are documented at each visit
Yes No [X] (If no skip question F)
B Does the providerrsquos process ensure that staff administering vaccine know which vaccine stock to select from prior to drawing the vaccine
Yes No [X]
C Number of records reviewed If fewer than 10 records are reviewed select the reason why Provider does not have 10 patient records with immunizations in last 12 months
D Do all records contain date of the immunization visit and patientrsquos date of birth Yes No [X]
E Do all records contain the patientrsquos specific eligibility status associated with thedate of the immunization
Yes No [X]
F Do any of the providerrsquos records contain any evidence that the patient received vaccine for which they were not eligible
Yes [X] No
Review CDC Requirement
VFC providers must screen for and document VFC eligibility at each immunization visit Documentation must include the date of the visit and the childrsquos specific eligibility category VFC providers must use screening results to ensure that only VFC-eligible children receive VFC vaccine and that administration fees are billed for as appropriate Eligibility status must be readily available to staff administering vaccine prior to selecting which vaccine stock to use
Goal of this question Ensure the site is screening for eligibility and documenting the eligibility category in the medical record
Review a minimum of 10 records from within the last 6-12 months where the patient received an immunization You must review a mix of public and private pay patients (if applicable)
Random selection is important If the staff have pre-selected records for review do not use and identify additional randomly selected records to review
Helpful information bull Discuss upgrading the electronic health record to make documentation of VFC eligibility screening a required field Documenting eligibility screening in the immunization field promotes better MIIC data
bull Q 31 B Sites using the replacement method of vaccine management only have one stock so you will answer ldquoYesrdquo to this question
Resources bull Patient Eligibility Screening Record on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfcformshtml)
bull Section 1 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 25
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 32
3 Documentation Vaccine Dose Documentation
Question 32 Review a minimum of 10 patient immunization records from the last six months (or 12 months ifnecessary) to assess compliance with documentation requirements set forth by Statute 42 US Code 300aa-25 (See note to reviewer below)
Note to Reviewer Criteria for Record Selection 1) Record selection must be completely random the Provider must not know prior to the visit which records
will be reviewed 2) Patient must have been 0-19 years of age at the last visit (Note Records of 19-year-old patients may allow
you to see if VFC vaccines are being used beyond the allowable age)
Records are Compliant if they Contain ALL the Below Elements
bull Address of clinic where vaccine was administered bull Publication date of VIS bull Name of vaccine administered bull Name of vaccine manufacturer bull Date vaccine was administered bull Lot number bull Date VIS was given bull Name and title of person who administered the
vaccine
A Number of records reviewed
B Number of records that contain ALL required documentation elements
If fewer than 10 records are reviewed select the reason why Provider does not have 10 patient records with immunizations in last 12 months
[X] Follow-up isrequired if one ormore records do not meet requirements
Goal of this question Assess whether the site is documenting all required information in each patientrsquos medical record for every vaccine dose administered in accordance with the National Childhood Vaccine Injury Act
Resources bull Section 6 of the MnVFC Policies and Procedures Manual bull National Vaccine Injury Compensation Program (wwwhrsagovvaccinecompensation)
Question 33
3 Documentation Record Retention
Question 33 Is the provider able to demonstrate (preferred) or clearly describe how they maintain historical VFCeligibility documentation for three years
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers are required to maintain all records related to the VFC program for a minimum of three years (or longer if requiredby state law) and upon request make these records available for review VFC records include but are not limited to VFC screening and eligibility documentation billing records medical records that verify receipt of vaccine vaccine ordering records and vaccinepurchase and accountability records
Goal of this question Make sure the site understands they are required to keep all MnVFC screening documentation for at least three years either electronically or on paper This information should be available to you at the time of the visit and future visits
Resource bull Section 7 of the MnVFC Policies and Procedures Manual
Page 26 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 34
3 Documentation Borrowing Documentation
Question 34 Discuss borrowing practices with the provider to answer the questions below
Note to Reviewer bull To be considered ldquofully documentedrdquo documentation for each borrowed dose must include thefollowing information
Vaccine type borrowed Date the dose was administered Stock used (VFC or private) Reason appropriate vaccine stock was not used Patient name and date of birth Date dose was returned to appropriate stock
A Did the provider state that they had borrowed any vaccines (whetherdocumented or not) since the last VFC Compliance Site Visit
Yes No (If no skip to question 36)
B Are there any doses for which there is no documentation (ie provider hasindicated that doses were borrowed but cannot verify how many or why)
All doses are documented Some doses are not documented [X] No doses are documented [X] (if nodoses documented skip toquestion 36)
C Were all borrowed doses fully documented (See Note to Reviewer above) Yes No [X]
D Were all borrowed VFC doses either replaced or an order submitted to replacethe doses Yes No [X]
Review CDC Requirement
VFC providers are expected to maintain an adequate inventory of vaccine for VFC and non-VFC-eligible patients It is theresponsibility of the VFC provider to appropriately schedule and place vaccine orders VFC providers must also rotate stock to ensure timely use of short-dated vaccines Borrowing of vaccine between private and public inventories must be a rare unplanned occurrence and cannot serve as a replacement system for a VFC providerrsquos privately purchased vaccine inventory All instances ofborrowing must be properly documented reported and replaced
Goal of this question Assess vaccine accountability by verifying that children are receiving vaccine from the appropriate stock
Borrowing is when a fully insured child receives a dose of MnVFC vaccine or a MnVFC-eligible child receives a dose of private vaccine This should be a rare unplanned occurrence The site must document any borrowing of vaccine between stocks ideally on the VFC Borrowing Report Form If they are not currently using the form review it with them and encourage them to post it close to their vaccines It does not need to be sent to MDH but should be kept for 3 years and filed with their MnVFC documents to be reviewed whenever they have a regular or unscheduled (unannounced) site visit
Helpful information bull Understand and report on staffrsquos verbal (ie anecdotal) accounts of borrowing obtained during the visit Often sites do not know that what they do is considered borrowing or they think borrowing is acceptable and documentation isnrsquot needed so long as those vaccines are eventually replaced
bull Since sites using the replacement method only have one stock of vaccine they very rarely borrow bull This question asks for future follow-up in 6 months Make a note on your calendar and ask them to send you a copy of their borrowing reports for the previous 6 months with documentation of doses borrowed and replaced We will remind you if we donrsquot hear from you at the 6 month time frame Complete the Follow-up Form and attach the borrowing form
Resources bull Vaccine Borrowing Report on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfc formshtml)
bull Section 10 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 27
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 353 Documentation Borrowing Reasons
Question 35 Based on your discussion with the provider and a review of borrowing reports document the dosesborrowed for each reason and answer the questions below
Note to Reviewer bull Short-dated vaccines are doses that are likely to expire before they can be used bull Exchanging short-dated vaccines should only occur in practices that have a small number of private
patients
A Reasons for Borrowing a VFC Dose (Enter the number of _____ Private vaccine shipment delay (order placed on time but delay in shippingreceipt)
vaccine doses borrowed for each
reason in the spaces
_____ Private vaccine not useable on arrival (vials broken temperature monitor out of range) _____ Ran out of private vaccine between orders (provider orders not placed on time) [X]
provided) _____ Short-dated private dose was exchanged with VFC stock _____ Accidental use of VFC dose for a private patient (human error) _____ Replacement of private dose with VFC when insurance plan did not cover vaccine _____ OtherDocumented dose did not include reason for borrowing [X]
(Explanation Required) Reasons for Borrowing a Private Dose _____ VFC vaccine shipment delay (order placed on time but delay in shippingreceipt) _____ VFC vaccine not useable on arrival (vials broken temperature monitor out of range) _____ Ran out of VFC stock between orders (provider orders not placed on time) [X] _____ Short-dated VFC vaccine dose was exchanged with private dose _____ Accidental use of a private dose for a VFC-eligible patient (human error) _____ OtherDocumented dose did not include reason for borrowing [X]
(Explanation Required)
B Enter date range for instances of borrowing reviewed in the borrowing report Note If ldquoDate of earliest instancerdquo is not available use the date of the last VFC Compliance Visit If ldquoDate of last instancerdquo is not available use the date of thecurrent VFC Compliance Visit
Date of earliest instance
Date of last instance
C Does borrowing appear to be a routine practice Note To determine whether borrowing is a routine practice assess frequency of and repeating reasons for borrowing Examples Frequent accidental use of incorrect stock exchanging short-dated vaccines or issues with ordering and shipment
Yes [X] No
Goal of this question Determine the reasons why the site is borrowing vaccine
If sites are using the Vaccine Borrowing Report review the reasons for borrowing to help document borrowed VFC andor private doses If they have not been documenting borrowing on this report (or any other form) estimate their borrowing practices If you do not know the date range for their borrowing use the last site visit date to the current visit date The use of ldquootherrdquo as the reported reason for borrowing should be rare if ever and would require explanation and follow up
Helpful information bull Look to see if they routinely maintain insufficient amounts or types of vaccine to support their public and private patients that leads to borrowing
bull Pay attention to borrowing cases documented as ldquoaccidentalrdquo Repetitive accidental borrowing may indicate an issue with ordering processes or insufficient staff training
bull Borrowing is not a place to document wasted or lost doses bull The time period of the borrowing may give you clues about the root cause Were the borrowed doses concentrated in a short period or spread out across several months or a year Are all vaccine types being borrowed or just one
bull If borrowing seems to be an issue discuss vaccine management ordering procedures
Resources bull Vaccine Borrowing Report on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfc formshtml)
bull Section 10 in the MnVFC Policies and Procedures Manual
Page 28 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 36
3 Documentation Vaccine Management Plan
Question 36 Physically review the providerrsquos Vaccine Management Plan to answer the question below
A Does the provider have a Vaccine Management Plan Yes No [X] (If no skip to question 37)
B Does the plan list the current Immunization Manager Vaccine Coordinator andback-up
Yes No [X]
C Does the plan address proper vaccine storage and handling practices Yes No [X]
D Does the plan specify vaccine receiving procedures Yes No [X]
E Does the plan contain procedures for what to do with vaccine in the event of an emergency
Yes No [X]
F Does the plan contain procedures for vaccine ordering Yes No [X]
G Does the plan address inventory control (example stock rotation) Yes No [X]
H Does the plan address how to handle vaccine wastage Yes No [X]
I Does the plan address staff training and documentation on vaccine managementstorage amp handling
Yes No [X]
J Does the plan contain a review date that falls within the last 12 months Yes No [X]
K Has the plan been signed by the individual responsible for its content Yes No [X]
Review CDC Requirement
VFC providers must develop maintain and implement a Vaccine Management Plan for routine and emergency vaccinemanagement The plan must contain the current Vaccine Coordinator and back-up proper storage and handling practicesshipping and receiving procedures emergency procedures procedures for vaccine ordering inventory control (eg stock rotation)how to handle vaccine wastage and staff trainingdocumentation on vaccine management storage and handling The plan must bereviewedupdated annually or more frequently if changes occur A ldquoreview daterdquo and signature are required on all plans in order tovalidate that they are current
Goal of this question Evaluate the sitersquos plan for vaccine management It is especially important that they have a plan for emergency management of their vaccine in the case of equipment failure or power outage Encourage all sites to read and sign the MnVFC Policies and Procedures Manual and complete the emergency plan or be able to show you a plan of their own
If the provider is not able to physically show you the plan at the time of the visit or if the recorded review date is not within the last 12 months you must mark that this requirement is unmet The Vaccine Management Plan is important in times of emergency and it should be easy to access by any staff member at any time Encourage them to post the plan and put a copy with the packing supplies
Helpful information bull Encourage the site to fill in the ldquoImmunization Managerrdquo and ldquoVaccine Coordinatorrdquo fields in the
MnVFC Policies and Procedures Manual for their own referencebull The emergency plan in the manual can be reviewed from last year and included in this yearrsquos manual (with an updated signature and date) if there have not been any changes
bull If information in the plan is outdated site staff will not be well equipped to safely manage vaccines in the event of a power-outage or other emergency situation
bull If their institutional policy is only reviewed and updated every 3-4 years (as many are) the staff may need to sign the MnVFC Polices and Procedure Manual to meet this requirement
Resource Routine Vaccine Management Plan and Emergency Vaccine Management Plan in the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 29
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 37
3 Documentation VIS amp VAERS
Question 37 Review the providerrsquos Vaccine Information Statements (VISs) and discuss providerrsquos VAERS process toanswer the questions below
A Does the provider have readily available up-to-date VISs for all ACIP-recommendedvaccines relevant to the populations it serves
Yes No [X]
B Does the provider make a VIS available for patientsparents before eachvaccination
Yes No [X]
C Does the provider know how and when to report clinically significant adverseevents using VAERS
Yes No [X]
Review CDC Requirement
VFC providers are required to distribute the current Vaccine Information Statements (VIS) each time a vaccine is administered and maintain records in accordance with the National Childhood Vaccine Injury Act (NCVIA) which includes reporting clinicallysignificant adverse events to the Vaccine Adverse Event Reporting System (VAERS) For a list of current VISs visit CDCrsquos Vaccine Information Statements (httpwwwcdcgovvaccineshcpvis) website
Gal of this question Ensure the site has the most current VISs and is giving them to each patientparent before administering the vaccine in compliance with the federal law Parents must be educated about the vaccine their child will receive and be aware of possible contraindications and side-effects in order to make well-informed decisions about their childrsquos health
Helpful information bull Ask to see the sitersquos VISs to determine if they have an active protocol for giving VISs to parents Review to make sure they are current Ask if they know where and how to report vaccine adverse events
Resources bull Section 3 in the MnVFC Policies and Procedures Manual bull CDC Vaccine Information Statements (wwwcdcgovvaccineshcpvisindexhtml) Site may sign up for email updates for the current list of VIS publication dates for the most up-to-date version
bull IAC Itrsquos Federal Law You must give your patients current Vaccine Information Statements (wwwimmunizeorgcatgdp2027pdf)
bull VAERS (httpsvaershhsgovindex)
Question 38
3 Documentation Anaphylaxis protocol
Question 38 Does the site have an anaphylaxis protocol which is clearly posted near the emergency kit
Answers (Choose one)
Yes No [X]
Review CDC Requirement
An anaphylaxis protocol must be clearly posted in the area where vaccines are administered
Goal of this question Make sure site is prepared for a severe allergic or anaphylactic reaction to a vaccine
Resources bull Section 11 in the MnVFC Policies and Procedures Manual bull IAC protocols Child and Teens (wwwimmunizeorgcatgdp3082apdf) and Adults (wwwimmunize orgcatgdp3082pdf)
Page 30 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
i
i i i - li i i i i i l
Section 4 Storage amp Handling Per Unit The goal of this section is to assess vaccine storage
2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet practices in each unit at the site MnVFC PIN ___________________
The 2017 MnVFC Storage amp Handling Per Unit Answer Sheet is a worksheet to document the answers to the questions in this section for each unit (combination or stand-alone) Fill in the answers to the questions in Section 4 on the answer sheet not in the questionnaire
The answer sheet has an abbreviated form of each question If you need further information on that question refer back to the full questionnaire Also if you find an area where the site is not meeting the requirements you will need to go back to that question on the 2017 MnVFC Site Visit Questionnaire to complete ldquoActions if Non- compliantrdquo section including the root cause analysis and follow-up sections If there is a problem in more than one unit make a note on the questionnaire which unit you are referring to in the Notes section
Important You must fully assess any unit that may be used to store VFC vaccines even if there are no VFC vaccines there on the day of the visit If there are no vaccines and the site is not documenting twice a day temperatures discuss the need to ensure the unit is maintaining stable temperatures by monitoring for one week before placing vaccines in the unit
Quest on number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
for the freezer and e co umn
Temperature Monitoring Dev refr gerator f the un
ce Quest ons Quest ons 4 3 4 7 must be answered separate y t s a combo Be sure to document responses n the appropr at
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
44D Data downloaded and reviewed routinely (eg weekly)
Yes No [O]
Yes No [O]
45A Certificate of Calibration Testing Yes No [X]
Yes No [X]
45B Date of calibration
45C Date certificate expires [X] Follow-up is required if expired [X] Follow-up is required if expired
45D Certificate contains all necessary items
Yes No [X]
Yes No [X]
46 Probe properly placed Yes No [X]
Yes No [X]
47A Two temperature readings per day
Yes No [X]
Yes No [X]
47B Time date and name (or initials) for each reading
Yes No [X]
Yes No [X]
47C Current temperature and minmax temperatures (if
Current ________deg Minimum ________deg Maximum _deg
Current ________deg Minimum ________deg Maximum _deg
Sections 5 and 6 contain questions about storage and handling site wide and inventory It is helpful to keep those questions in mind as you assess the individual storage units Think about dorm-style units expired vaccine vaccine supply room for vaccine stocking all the recommended vaccines and separation of stock if appropriate
NOTE The sections that follow require reviewers to validate responses by looking at vaccine storage units temperaturemonitoring equipment and the vaccine inventory inside a unit bull For section 4 use a separate Storage amp Handling Per Unit Answer Sheet for each unit to document the findings (combination
units using both sections can be documented on the same answer sheet) bull When an unmet requirement is identified return to this questionnaire to complete the ldquoActions if Non-compliantrdquo section for
that question bull After you complete one answer sheet for each unit return to the questionnaire to complete sections 5 and 6 using information
you gathered while assessing the units The questions in sections 5 and 6 (Storage amp Handling Site-Wide and Inventory) are notunit-specific but do require that the response be based on a thorough assessment of all the providersrsquo units
4 Storage amp Handling Per Unit
Description On the Storage amp Handling Per Unit Answer Sheet place a name that will allow you or someone else from your program to easily identify this unit in the event of follow-up We recommend using Brand + Location(example Samsung - Room 123) Save each Storage amp Handling Per Unit Answer Sheet with the Brand + Location in the file name
(example SamsungRoom123doc)
IPI Advisor Manual | February 2017 Page 31
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 41
4 Storage amp Handling Per Unit Storage Unit Build amp Use
Question 41 Below select the build and use of the vaccine storage unit you are assessing
Note to Reviewer Dorm-style units Do not add dorm-style units here Dorm-style units will be addressed in section 5 Units storing only private stock You must review these storage units even if they contain only private stockat the time of the visit because that vaccine could be administered to VFC patients
A What type of unit is this A Stand-alone B Combination
B Select use if stand-alone A Freezer B Refrigerator
Select use if combination A Use both sections to store vaccine B Use freezer section only to store vaccine C Use refrigerator section only to store vaccine
Goal of this question Identify the unit you are evaluating The description asks you to create a unique name for this unit so that you will be able to identify the same unit in future site visits Put this description on the top of the answer sheet (ie make and location)
Helpful information bull A stand-alone unit is either a refrigerator or a freezer It does not have both sections in the unit bull If there is a combination unit note if the site uses both the refrigerator and freezer or only one section of the unit to store vaccines CDC does not recommend the use of either section or the freezer section only of combination household units
bull If your site utilizes the separate stock method of vaccine management you must review storage units even if they contain only private stock at the time of the visit because there is a chance that those vaccines could be administered (borrowed) to VFC-eligible patients
Page 32 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 424 Storage amp Handling Per Unit CDC Recommended Storage Units
Question 42 Below document the grade of the vaccine storage unit you are assessing
Note to Reviewer Pharmaceutical Also called ldquopurpose-builtrdquo these units are designed by the manufacturer specifically tostore vaccines or other biological materials Commercial Although usually intended to store food and beverages commercial units are often larger and more powerful than the household units found in most homes Though these units are intended to meet thehigher demands of larger facilities these units are not specifically built for the storage of biologicalmaterials Household (non-commercialdomestic) These units are usually smaller than commercial units and areintended for use in small offices and in homes ndash typically for food storage However just like commercialunits they are not designed specifically for the storage of biological materials Such units are usually available in common home supply stores
Answers (Choose one)
Select grade A Pharmaceutical B CommercialHousehold
[O] CDC does not recommend the use of both sections or the freezer section only of combination commercialhousehold units
Review CDC Recommendation
CDC recommends the following vaccine storage unit types (in order of preference) pharmaceutical grade stand-alone orcombination units (preferred) householdcommercial stand-alone units householdcommercial combination units using therefrigerator section only
Goal of this question Assess the grade and type of each storage unit bull Pharmaceutical grade units may be stand-alone or combination units that are often metal may have glass in the door for viewing inside often have an external digital temperature display and are manufactured by medical companies
bull Commercial or household units often look like your kitchen appliance have vegetablemeat drawers in the unit and are manufactured by household appliance companies
bull Occasionally you might find a medical grade unit which is usually a commercialhousehold unit with a lock and 3-prong plug These are still considered household units because of their ability to maintain proper temperatures and air flow Studies show that household stand-alone units are better able to maintain consistent temperatures than their combination counterparts Combination household units used to store vaccine in both sections of the unit is no longer recommended and may be prohibited in the future Combination household storage units that are having difficulty maintaining a cold enough freezer temperature and a warm enough refrigerator temperature should be replaced or a separate stand-alone freezer should be purchased
For frozen vaccines the most cost effective solution is for the site to purchase a small stand-alone freezer The site may need time to budget for a stand-alone storage unit
Resources bull Replacing Combination Household Units Tip Sheet on IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml)
IPI Advisor Manual | February 2017 Page 33
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 434 Storage amp Handling Per Unit Temperature Monitoring Device in the Unit
Question 43 Determine whether there is a temperature monitoring device in this section of the storage unit andanswer the questions
A Is there a temperature monitoring device in this section of thestorage unit
Yes No [X] (If no skip to question 47)
B Who is responsible for supplying the temperature monitoring device in this section of the storage unit Provider
Review CDC Requirement
Certificates of calibration testing provide confidence that the temperature monitoring device is measuring temperaturesaccurately All units storing VFC vaccines must have a calibrated temperature monitoring device with a current and valid certificateof calibration testing All certificates must contain modeldevice name or number serial number date of calibration testing (report or issue date) and Instrument Passed testingInstrument in Tolerance (Recommended uncertainty = +-05ordm C (+-1ordm F))
Goal of this question Assess whether there is a temperature monitoring device in the unit If the unit is not being monitored at all call MDH at 651-201-5522 for guidance
Helpful information bull This question does not ask whether the temperature monitoring device is working or the characteristics of the device These issues will be addressed later in the questionnaire
bull For part B the provider is always responsible for supplying the temperature monitoring device Even if their thermometer or data logger was originally from MDH it is their responsibility to ensure it is functional and calibrated
Resources bull Section 8 in the MnVFC Policies and Procedures Manual
Page 34 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 444 Storage amp Handling Per Unit CDC Recommended Temperature Monitoring Device
Question 44 Assess the temperature monitoring device in this section of the storage unit to answer the questionsbelow
A Is the temperature monitoring device a continuous monitoring and recordingdevice (eg data logger)
Yes No [O] (Skip D)
B Does the temperature monitoring device have a probe in buffered material Yes No [O]
C Does the temperature monitoring device have a digital display that can beeasily read from the outside of this unit
Yes No [O]
D Is data downloaded and reviewed routinely Yes No [O]
Review CDC Recommendation
As of Jan 1 2018 all VFC providers must use continuous temperature monitoring devices (eg data loggers) to monitor vaccinesthat will be administered to VFC-eligible children Routine review and accessibility of temperature data is critical for determining whether vaccine has been properly stored and for assessing usability of vaccine that was involved in a temperature excursion Tomeet VFC Program requirements the device must also be equipped with bull A temperature probe bull An active temperature display that can be easily read from the outside of the unit bull The capacity for continuous monitoring and recording capabilities where the data can be routinely downloaded
The following are additional recommended features for these devices bull Alarm for out-of-range temperatures bull Current minimum and maximum temperatures display bull Low battery indicator bull Accuracy of +- 1degF (05degC) bull Memory storage of at least 4000 readings bull User programmable logging interval (or reading rate) recommended at a maximum time interval of every 30 minutes bull Use of a probe that best reflects the temperature of the vaccine (such as a buffered probe)
Goal of this question Assess the temperature monitoring device in the storage unit Note that these are all recommendations not requirements at this time
This is a great teaching opportunity for sites who do not currently have a continuous temperature monitoring device Beginning Jan 1 2018 all units that store MnVFC vaccine will be required to have a continuous temperature monitoring device (ie a data logger or a continuous temperature monitoring system) Unlike a minmax thermometer a continuous temperature monitoring device provides detailed information on all temperatures recorded at pre-set intervals For excursions it can provide information on when a temperature went out-of-range for how long and what the temperatures were This is essential information that vaccine manufacturers need to know to assess the viability of the vaccine following an excursion
Helpful information bull Sites are required to monitor and record temperatures twice daily however temperature excursions can easily occur in the 12 hours or longer between readings Continuous temperature monitoring can help manufacturers determine vaccine viability
bull Continue to encourage sites to document and evaluate minimum and maximum temperatures the storage unit reached since the last reading and respond appropriately to out-of-range temperatures
IPI Advisor Manual | February 2017 Page 35
The 2017 MnVFC Site Visit Paperwork Chapter 4
bull It is recommended that sites download and review data weekly Discuss with sites that reviewing temperature monitoring device data also includes responding appropriately if they identify out-of-range temps
bull There is sometimes confusion about the difference between a data logger and a continuous temperature monitoring system Here are some differences
Data Loggers Continuous Monitoring Systems Have an external display similar to thermometers May or may not have an external display Have a detachable probe Probe is usually attached to transmitter Need to be plugged into the computer or cradle to download information on a regular schedule
Wirelessly sends data to computer system
Create a file of data that needs to be saved on the computer
Data is stored within the system not a separate file
Doesnrsquot allow documentation of twice a day temperature checks in the file
May allow documentation of twice a day temperature checks within the system
More about the 2018 requirement for a continuous temperature monitoring device
Required Features bull The continuous temperature monitoring device must have Continuous monitoring and recording capabilities to track and record temperatures over time The capacity to routinely download temperature data to a computer (recommended at least weekly) or wirelessly transmit data Detachable probe in a bottle filled with a thermal buffer (eg bio-safe glycol) if the data logger needs to be detached in order to download data Active temperature display
Recommended Features bull MnVFC recommends continuous temperature monitoring devices with Alarm for out-of-range temperatures Accuracy within +-1degF (+- 05degC) Low battery indicator Display of current minimum and maximum temperatures Memory storage of at least 4000 readings User programmable logging intervals (eg the user can set how often the device records the temperature)
Note that these are all currently recommendations not requirements yet
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Page 36 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 45
Goal of this question Ensure the temperature monitoring device is properly calibrated The certificate of calibration testing means that the device has been tested and it is accurately measuring temperatures within established testing limits The certificate of calibration ensures that the device meets all the required components
Helpful information bull The provider is always responsible for having a current certificate of calibration (or copy) on-site
bull To be considered ldquovalidrdquo a certificate of calibration must contain these required elements Modeldevice name or number Serial number
4 Storage amp Handling Per Unit Certificate of Calibration Testing
Review CDC Requirement
Certificates of calibration testing provide confidence that the temperature monitoring device is measuring temperaturesaccurately All units storing VFC vaccines must have a calibrated temperature monitoring device with a current and valid certificateof calibration testing All certificates must contain modeldevice name or number serial number date of calibration testing (report or issue date) and Instrument Passed testingInstrument in Tolerance (Recommended uncertainty = +-05ordm C (+-1ordm F))
Question 45
Note to Reviewer
A
B
C
D
E
Review the certificate of calibration testing for the temperature monitoring device in this section of the storage unit and answer the questions below
bull How to determine certificate of calibration testing expiration date 1) Identify the certificate issuecalibration date 2) Apply the Immunization Program-required frequency for calibration testing Example If the
issuecalibration date is 12312013 and Immunization Program policy requires testing every twoyears the expiration date is 12312015
bull Certificates must include all of the below bull ModelDevice Name or Number bull Serial Number bull Date of Calibration Testing (Report or Issue Date) bull Instrument Passed testing (Instrument in Tolerance)
Is there a certificate of calibration testing for the temperature monitoring Yes device in this section of the storage unit No [X]
What is the date of calibration for the temperature monitoring device in this section of the storage unit
What is the certificatersquos date of expiration based on ImmunizationProgram policy (See note to reviewer to determine expiration date) [X] Follow-up is required if
certificate is expired
Does the certificate contain all the necessary items listed in the Note to Yes Reviewer No [X]
Who is responsible for supplying the current and valid certificate of Provider calibration for this temperature monitoring device
Date of calibration testing (report or issue date) Note If there is no expiration date the certificate expires 2 years from the date of calibration Whether the instrument passed or failed testing (or instrument in tolerancenot in tolerance)
bull Recommended element Documented uncertainty of +- 1degF [05degC]
If these elements are present the certificate is considered valid If the certificate contains information about the recommended element or the entity that issued the certificate that is helpful but not required
To determine if a certificate of calibration testing was issued by an appropriate entity check to see if the certificate indicates one or more of these items (this is the wording used to help sites evaluate if their calibration is accurate but is not required on the certificate itself to be considered valid)
bull Conforms to ISO 17025 bull Performed by an ILACMRA Signatory body accredited laboratory You can review this list of the ILAC MRA and Signatories (httpilacorgilac-mra-and-signatories)
bull Traceable to the standards maintained by NIST bull Meets specifications and testing requirements for the American Society for Testing and Materials (ASTM) Standard E2877 tolerance Class F (le 05 degC) or better
bull Includes reference to another acceptable accuracy validation method such as comparison to other traceable reference standards or tests at thermometric fixed points
Note CDC recommends that certifications be issued for the entire monitoring unit (detachable probe data logger etc) and not individual certificates for each component
IPI Advisor Manual | February 2017 Page 37
The 2017 MnVFC Site Visit Paperwork Chapter 4
For 45 E the provider is always responsible for supplying the current and valid certificate of calibration for a temperature monitoring device
bull Tip If the temperature monitoring device has a sticker on the back with the calibration date the site can usually call the company who calibrated the device and get a copy of the certificate if they donrsquot have one
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 46 4 Storage amp Handling Per Unit Probe Placement
Question 46 Is the probe properly placed in this section of the storage unit
Note to Reviewer ldquoProperlyrdquo means that the probe in a commercial or household unit is placed in a central area of the unitdirectly with the vaccines Probes should not be placed in the doors near or against the walls close to vents or on the floor of the unit The only allowable exemption related to this requirement is for providerswho have pharmaceutical storage units (built for vaccine storage) that have either (1) a built-intemperature monitoring device OR (2) a dedicated port for the probe that dictates the placement of theprobe
Answers (Choose one)
Yes No [X]
Review CDC Requirement
The probe must be placed in a central area of the section of the storage unit directly with the vaccines in order to properly measurevaccine temperature The probe should not be placed in the door near or against the walls close to vents or on the floor of theunit For pharmaceutical units with a built-in temperature monitoring device or a dedicated port for a probe that is not in thecenter of the section of the storage unit consult your Immunization Program for guidance on placement
Goal of this question Make sure the temperature monitoring device is in the best location to accurately measure the temperature of the vaccines stored in the unit
Helpful information bull The probe of the temperature monitoring device should be placed directly with the vaccines in the middle of the unit The ONLY allowable exception is for pharmaceutical storage units that have either a built-in thermometer or a dedicated port for the probe that indicates placement of the probe
bull Temperatures can vary within the unit especially household units bull Call MDH at 651-201-5522 if you have questions
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Guide (wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml)
Page 38 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 474 Storage amp Handling Per Unit Temperature Documentation
Question 47 Review the temperature documentation over the past three months for this section of the storage unit todetermine whether the provider has a process in place for properly documenting temperatures twice aday Answer the questions below
A Are there two temperature readings recorded for this section of the storage unit per day
Yes No [X]
B Is there a time date and name (or initials) recorded for each reading Yes No [X]
C What is the current temperature and minmax temperatures (if available) inthis section of the storage unit Use the reviewerrsquos thermometer if the providerrsquos temperature monitoringdevice does not have a current valid certificate of calibration testing or the probe is not properly placed in this section of the storage unit
Current Temperature Minimum Temperature Maximum Temperature Fahrenheit Celsius
D Based on your review of the providerrsquos recent temperature documentationincluding the current temperature is this section of the storage unitmaintaining appropriate temperatures
Yes No [X] Not enough information [X]
Review CDC Requirement
Vaccines must be stored under appropriate temperatures as described in the package inserts at all times Acceptable temperature ranges vary by vaccine type and the range is 36deg F and 46deg F (2deg C and 8deg C) and for frozen vaccines the range is -58deg F and +5deg F (shy50deg C and -15deg C) Exposure to temperatures outside of those included in the package inserts could affect vaccine viability andultimately could leave children unprotected against vaccine-preventable diseases In order to maintain awareness of storage unittemperatures and ensure that vaccines are being stored at appropriate temperatures at all times VFC providers are required to monitor and document temperatures for all vaccine storage units at least twice a day Temperature documentation must contain (1) at least two temperature readings per day (2) the time and date of each reading and (3) the name (or initials) of the personwho assessed and recorded the readings CDC also recommends that VFC providers record the minimum and maximumtemperatures of each unit once each workday (preferably in the morning)
Goal of this question Ensure the temperature is being monitored twice daily is within the required range and documented correctly Use your thermometer to check the temperature if the sitersquos temperature monitoring devicersquos probe is not properly placed or there is not a current certificate of calibration Place your thermometer in the unit at the beginning of the visit to allow sufficient time to reach an accurate temperature The purpose of using your thermometer is to ensure the vaccine is being stored at the proper temperature not to ldquovalidaterdquo their reading
Question 47 D is an assessment question based on information you have learned during your visit You might answer ldquonot enough informationrdquo if the unit is new and they donrsquot have at least three months of data or if the unit is only used as overflow and they are inconsistent with temperature monitoring Mark ldquoNordquo if you have reason to believe the storage unit is not maintaining temperatures properly
Helpful information bull All sites must document temperatures twice a day every day the site is open even if they have a data logger or continuous monitoring system
bull Sites can document the information electronically with some continuous monitoring systems as long as it can show what the current temp is the date time and initials of the person checking ndash this needs to be someone at the site ndash not checking remotely or centrally for a large site or system The site must be able to produce these records during their site visit Reviewing these files can be a challenge due to large volumes and lots of paper
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Temperature Logs on Managing Vaccine (wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml)
IPI Advisor Manual | February 2017 Page 39
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 484 Storage amp Handling Per Unit Temperature Excursions
Question 48 In the event that a temperature excursion(s) occurred in this unit within the last three months requestand review documentation of actions taken to determine whether the provider has a process for properlyaddressing excursions Answer the questions below
A Were vaccines in this unit exposed to out-of-range temperatures in the lastthree months (including today)
Yes No (If no skip to question 49)
B Did the provider quarantine and label vaccines as ldquoDo not userdquo Yes No [X]
C Did the provider place vaccine in a unit where it can be stored under properconditions if applicable
Yes No [X]
D Did the provider contact the Immunization Program to report theexcursion
Yes No [X]
E Was the manufacturer contacted for documentation supporting theusability of the vaccine
Yes No [X]
Review CDC Requirement
The provider must document all excursions and actions taken including the following (1) Quarantine and label vaccines as ldquoDO NOTUSErdquo (2) Place vaccines in a unit where they can be stored under proper conditions (3) Contact the Immunization Program to report an excursion and (4) Contact the vaccine manufacturer to obtain documentation supporting the usability of the vaccine
Goal of this question Address any out-of-range temperatures (temperature excursions) identified in reviewing the last three months of temperature logs or during the site visit If there were any out-of-range temperatures did the site respond appropriately to the situation This is a great opportunity to discuss what to do in the event of an excursion The Clinicians Storage and Handling Mishap Checklist is in the IPI Site Visit information folder and is a good review of the process
Helpful information bull Sites need to know that an excursion does not automatically mean that exposed vaccines are non-viable or unusable Exposed vaccines must be quarantined (marked ldquoDo Not Userdquo) and stored under proper conditions until they have received information from vaccine manufacturers regarding the viability of the vaccine
bull Sites must inform MDH when an excursion occurs
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Clinicians Storage and Handling Mishap Checklist (wwwhealthstatemnusdivsidepcimmunize ipivaxchklstpdf)
Page 40 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 49
Goal of this question Ensure proper placement of vaccines in the storage unit
Note These are all recommendations (best practices) not requirements
Helpful information bull Store vaccine in the middle of the compartment two to three inches away from the coils walls floor and cold air vent The temperature near the floor and walls of the unit differs from that in the middle of the compartment and the cold air vent can freeze refrigerated vaccines
4 Storage amp Handling Per Unit Vaccine Placement
Question 49 Look inside the unit to answer the questions below
A Are vaccines placed in the middle of the unit with space between vaccinesand the sideback of the unit to allow cold air to circulate
Yes No [O]
B Are vaccines stored in their original packages Yes No [O]
C Are there water bottles (for refrigerators) or frozen water bottles (forfreezers) in the unit
Yes No [O]
D Are vaccines store in the doors vegetable bins under or near cooling ventsor on the floor of the unit
Yes [O] No
E Is food being stored in the unit Yes [O] No
Review CDC Recommendation
Vaccines should be stored in their original manufacturer (or CDC centralized distributor) packaging They should be placed in the middle of the unit with space between the vaccines and the sideback of the unit to allow cold air to circulate Vaccines SHOULD NOT be stored in the doors vegetable bins or floor of the unit or under or near cooling vents and there should not be any food inthe unit Water bottles (for refrigerators) or frozen water bottles (for freezers) should be placed throughout each storage unit inorder to (1) stabilize or extend temperatures during a power outage and (2) to serve as physical blocks preventing the placementof vaccines in areas of the unit that are at higher risk for temperature excursions (such as in doors vegetable bins floor ornearunder cooling vents)
bull Vaccines should be kept in their original packaging to Protect them from light Help prevent medication errors by making labels easier to read Provide a moisture barrier that serves as insulation in case of an out-of-range temperature power outage door left open or mechanical failure Simplify managing vaccine inventory
bull Store water bottles in the doors on the floor and near the cold air vent in the refrigerator and frozen water bottles in the freezer to help maintain a stable temperature if there is a power failure and when the door is opened frequently Too many water bottles in the door can prevent the door from closing tightly Mark water bottles ldquoDo Not Drinkrdquo
bull Do not store vaccine in the door or drawers of the refrigerator or freezer Vegetable bins and crisper drawers should be removed from refrigerators or used to store other medical supplies or water bottles
bull If vaccine is stored in a household combination refrigeratorfreezer The top shelf should not be used for storing vaccine because the cold air vent blowing from the freezer will freeze vaccine located there If you must use the top shelf of this type of unit place water bottles underneath the cold air vent to prevent vaccine from being stored there It is recommended that only the refrigerator be used for vaccine storage and a separate stand-alone freezer be used to store frozen vaccine
bull Must not store food or beverages in the refrigerator or freezer because frequent opening of doors can lead to temperature variations that may affect vaccine viability There is also a risk of contaminating vaccines
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Guide (wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml) bull Vaccine Storage Tip Sheet on IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml)
IPI Advisor Manual | February 2017 Page 41
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 4104 Storage amp Handling Per Unit Disconnection from Power Source
Question 410 Ask the provider to demonstrate what measures are taken to ensure that vaccine storage units are notaccidentally physically disconnected from the power supply Which of the following describes the measure(s) taken on this unit
Note to Reviewer bull Large hospitals and healthcare systems may not have the ability to demonstrate labels on plugs or circuitbreakers In such cases verify that the practice has a comprehensive policy and standard operatingprocedures in place to prevent the vaccine storage unit from being physically disconnected from thepower supply
bull While back-up generators may ensure power to the overall facility this question ONLY addresses thevaccine storage unit being accidentally disconnected from the power source either through the plug orthe circuit breaker
Answers A ldquoDo not disconnectrdquo labels on the plug (Choose all that B ldquoWarningrdquo label on the circuit breaker box
apply) C Hard-wired (ie built-in) and has a ldquoDo not disconnectrdquo label on thecircuit breaker box D Hospital or large health care system with a comprehensive written policyand standard operating procedures detailing measures taken to preventvaccine storage units from being accidentally disconnected from the powersupply E No acceptable measures for preventing accidental disconnection frompower supply [X]
[X] The response is non-compliant if only A only B or E is selected
Review CDC Requirement
VFC providers must take steps to protect the power source for all vaccine storage equipment by means of having clear warninglabels on both the plug and the circuit breaker associated with all vaccine storage units Large hospitals and healthcare systems canmeet this requirement by demonstrating that they have comprehensive policies and standard operating procedures to preventvaccine storage units from being physically disconnected from the power supply
Goal of this question Decrease the chance that a vaccine storage unit will be accidently unplugged or power will be turned off while vaccine is in the unit This question addresses only what measures the site has taken to ensure the storage unit is not physically disconnected from its power source
If the site uses labels on the plugs and circuit breakers perform a visual inspection to assess whether the way the stickers are positioned make it clear and obvious to anyone that these units are not to be disconnected
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Do Not Unplug and Warning stickers are included in the folder or available to order on the For
Professionals Order Form (wwwhealthstatemnusdivsidepcimmunizeordermathtml)
Note Once you have completed the 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet for each unit return to the questionnaire to complete sections 5 and 6
Page 42 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
- -
Section 5 Storage amp Handling Site-Wide Question 51
5 Storage amp Handling Site Wide Discussion of Cost amp Quantity of Vaccine
Question 51 Have a discussion with the provider about the cost and quantity of VFC vaccines they are responsible for annually Address the points listed in the note to reviewer below
Note to Reviewer bull Vaccine Shipped (Required) Share the cost of VFC vaccines shipped to the provider in the last calendaryear to make sure the provider understands the contribution made by the VFC Program to their practiceFor new providers who do not have ldquocalendar yearrdquo data share either the actual cost of their currentinventory or use the cost of 10 VFC doses of each of the ACIP-recommended vaccines (approximately $7000) to help estimate their annual cost
bull Storage amp Handling (Required) Make sure the provider understands the cost of vaccines for which they are responsible when they make decisions about purchasing recommended vaccine storage and temperature monitoring equipment
Answer I have discussed with the provider the cost and quantity of vaccines ordered in the previous calendar year
Goal of this question Inform sites of the quantity and value of vaccines that they receive as part of the MnVFC program Providers often donrsquot realize the value of the vaccine in their unit This information is included on your clinic list and on the one page site-specific information
Helpful information bull This discussion must occur and the box on the questionnaire must be checked bull If there isnrsquot actual vaccine value information available tell the site that one vaccine order that includes a box of each of the ACIP recommended vaccines costs approximately $7000
bull MDH may not have specific information for individual sites if they receive vaccine from a central warehouse or pharmacy For those sites MDH will give you numbers for the whole system so you can discuss system wide data as appropriate If individual site information is also included it is usually just varicella-containing vaccines that must be shipped directly to the site
Question 52
5 Storage amp Handling Site Wide Dorm Style Units
Question 52 Determine whether the provider has any dorm-style units on site and answer the questions below
Note to Reviewer A dormitory-style refrigerator is a unit that has both refrigerator and freezer compartments behind a singleexterior door Dorm-style units also have an evaporator plate (cooling coil) which is usually located insidean icemaker compartment (freezer) within the refrigerator
A Does the provider have any dorm-style units that are used at any time tostore vaccines
Yes [X] No (Skip to question 53)
B Does the provider have sufficient space in existing compliant vaccinestorage units to store all vaccines without use of the dorm-style unit at any time
Yes No [X]
Review CDC Requirement
Dorm- and bar-style units are prohibited for vaccine storage Vaccines stored in dorm-style units are considered non-viable and must be returned to the centralized distributor CDC recommends the following vaccine storage unit types (in order of preference)pharmaceutical grade stand-alone or combination units (preferred) householdcommercial stand-alone unitshouseholdcommercial combination units using the refrigerator section only
Goal of this question Ensure no vaccine is stored in dorm-style units even for short periods of time Encourage them to label any units ldquoNo Vaccine Storage Allowedrdquo Vaccine stored in these units is considered non-viable If a site is using a dorm-style unit call the MnVFC program (651-201-5522)
Resource Section 8 in the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 43
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 535 Storage amp Handling Site Wide Storage Unit Space Availability
Question 53 Does the provider have sufficient room across storage units to store current stock as well as anyadditional stock acquired during peak season without overcrowding
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have sufficient storage space to accommodate vaccine stock at the busiest time of year without overcrowding
Goal of this question Ensure that sites have sufficient space in their units to maintain vaccines at the busiest time of year Overcrowding of vaccine limits air circulation and affects the unitrsquos ability to maintain stable temperatures
Helpful information bull Look for signs of overcrowding such as vaccines that are pushed up against the wall bins that are overflowing or storage units that are full during non-peak seasons
Discuss immediate actions if the unit is overcrowded Move some of their vaccines order less vaccine more frequently (once per month preferably) andor purchase another storage unit for overflow
Resource bull Section 8 MnVFC Policy and Procedure Manual
Page 44 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 545 Storage amp Handling Site Wide Expired Vaccines
Question 54 Look in each unit Are there expired vaccines in any of the vaccine storage units at this site
Answers (Choose one)
Yes [X] No
Review CDC Requirement
Vaccines should be rotated weekly and when a new shipment comes in so that longer-dated vaccines are stored behind shorter-dated vaccines If vaccines expire they can no longer be stored in the same storage unit with viable vaccines They must be placedin a container or bag clearly labeled ldquoDo not userdquo and separated from viable vaccines to prevent inadvertent use Expired vaccinemust be returned to the centralized distributor within six months of expiration
Goal of this question Ensure there is no expired vaccine in any storage unit
Helpful information bull Sites can prevent their stock from expiring by rotating vaccines every week andor when a new shipment arrives Longer-dated vaccines are stored towards the back of the unit and shorter-dated vaccines are up front
bull Pay attention to vaccines that expire within the next three months Consider transferring vaccine that will expire soon to another MnVFC-enrolled site that will use the vaccine preferably a site close by It is the transferring sitersquos responsibility to arrange the transfer of the vaccine Be sure to complete the MDH Vaccine Transfer Record form and send it to MDH If they are having difficulty finding a location to accept vaccine contact MDH
bull This is a great opportunity to educate sites about the MDH Nonviable Vaccine Form and the process for returning vaccine The VFC program does get some credit for taxes and fees on vaccine that is returned to the distribution center
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MDH Nonviable Vaccine Form and MDH Vaccine Transfer Record on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfcformshtml)
IPI Advisor Manual | February 2017 Page 45
The 2017 MnVFC Site Visit Paperwork Chapter 4
- -
-
Question 555 Storage amp Handling Site Wide Back up Thermometer
Question 55 Does the provider have a readily available back-up thermometer with a current and valid certificate ofcalibration testing
Note to Reviewer ldquoReadily availablerdquo means that the thermometer is available to perform twice-a-day monitoring for a unit asrequired CDC recommends that the back-up thermometer be maintained on site
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have a readily available back-up thermometer with a current and valid certificate of calibration testing Toprevent the certificates of calibration testing of the primary and back-up thermometers from expiring at the same time the date of calibration testing (or issue date) of the back-up thermometer should be different from the date of calibration testing (or issue date) of the primary thermometer As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meetsVFC program requirements
Goal of this question Ensure sites have one calibrated back-up thermometer onsite that is readily available in the event that the temperature monitoring device in unit fails transportation of vaccine is needed or there are other unexpected circumstances
Helpful information bull As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meets VFC Program requirements
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 56 5 Storage amp Handling Site Wide Preparation of Vaccine
Question 56 When does this provider prepare vaccine for administration to the patient
Note to Reviewer For mass vaccination clinics if one type of vaccine is offered providers may pre-draw up to 10 doses Ifusing pre-filled syringes pre-drawing also means activating the syringe by removing the needle guard orattaching a needle
Answers (Choose all that
apply)
Prepare dose immediately before administration Pre-draw doses for upcoming patients (in a regular clinicpractice) [O] Pre-draw up to 10 doses (in a mass-vaccination clinic) Pre-draw more than 10 doses (in a mass-vaccination clinic) [O] Other [O]
Review CDC Recommendation
CDC recommends preparing vaccines immediately prior to administration in order to assure viability of vaccine and prevent vaccinewastage Vaccines that are not administered immediately are at risk of exposure to temperatures outside of the required rangewhich can affect vaccine viability and ultimately can leave children unprotected against vaccine-preventable diseases
Goal of this question Discuss proper timing and preparation of vaccine(s) for administration These are recommendations not requirements
Helpful information bull Educate staff on the importance of preparing vaccine immediately before administration Pre-drawing of vaccines may lead to concerns related to vaccine viability potency sterility and wastage
Page 46 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 6 Inventory Question 61
6 Inventory Inventory Comparison
Question 61 Visually inspect storage units to determine if existing supply of vaccines proportionately mirrorspopulations served Choose the most accurate statement below
Note to Reviewer bull CDC recommends that providers maintain a four-week supply of inventory bull For this question do not take into account vaccine types that the provider does not order Here simply
make sure that overall the vaccines in the providerrsquos storage units are available in sufficient amounts toserve their patient population
Answers (Choose one)
The current vaccine inventory proportionately reflects the populations identified Only public stock is insufficient [X] Only private stock is insufficient [X] Both public and private stock are insufficient [X] Site uses the replacement method but does not appear to have enough vaccine for their population [X] Other [X]
Review CDC Requirement
VFC providers must order and stock routine vaccines in accordance with their patient population in order to prevent missedvaccination opportunities Having sufficient amounts of all stocks prevents the inadvertent use of VFC vaccines for non-VFC-eligiblepatients and vice versa
Goal of this question Assess whether the site is ordering appropriate quantities of vaccine for the population they serve at their site
Helpful information bull If the site sees 30 percent private-pay patients and 70 percent VFC the stock in their storage units should reflect that proportion If you donrsquot know you can ask the site about their population
bull This is meant to be a general assessment so in a big site if they have only a small amount of vaccine that may indicate an issue with vaccine management
bull CDC recommends smaller more frequent orders (ie monthly) rather than large orders to minimize the amount of vaccine loss if an incident occurs during shipment or in the storage unit Sites should not order more frequently than once a month
bull Sites using the replacement method will only have one stock but it should appear to be large enough for their population
bull Only assess the vaccine types that the site currently stocks in their unit We know there are sites that do not offer all ACIP-recommended vaccines for various reasons That issue will be addressed in question 62
IPI Advisor Manual | February 2017 Page 47
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 626 Inventory ACIP Recommended Vaccines
Question 62 Review providerrsquos current inventory to answer the questions below
A Does the provider offer all routine ACIP-recommendedvaccines for their patient population
Yes (Skip to question C) No [X] Offers all except varicella because direct ship ofvaccine is unavailable from manufacturer
B Which routine vaccines are NOT being offered DTaP Hepatitis A Hepatitis B HIB HPV Influenza Meningococcal
MMR Pneumococcal Polio Rotavirus TdapTd Varicella
C According to Immunization Program Policy does theprovider make accessible all non-routine ACIP-recommended vaccines for those VFC patients whomeet the criteria for receiving them
Yes (Skip to question 63) No [X]
D Which non-routine vaccines are NOT being offered Pneumococcal polysaccharide vaccine (PPSV23) Meningococcal Group B (MenB) Other
Review CDC Requirement
VFC providers agree to comply with immunization schedules dosages and contraindications that are established by the Advisory Committee on Immunization Practices (ACIP) for the vaccines identified and agreed upon in the Provider Agreement UNLESS bull In the VFC providers medical judgment and in accordance with accepted medical practice the VFC provider deems such
compliance to be medically inappropriate for the child bull The particular requirements contradict state law including laws pertaining to religious and other exemptions The VFC program entitles children to the following vaccines DTaP Hepatitis A Hepatitis B HIB HPV Influenza MeningococcalMMR Pneumococcal Polio Rotavirus TdapTd and Varicella VFC providers are also required to ensure that VFC-eligible children have access to non-routine vaccines as needed
Goal of this question Assess if the site is offering all the ACIP-recommended vaccines for the population they serve and these vaccines are in stock on the day of the visit It is important that every MnVFC-eligible child that comes to a providerrsquos office for an immunization is vaccinated
Helpful information bull The Advisory Committee on Immunization Practices (ACIP) is a group of medical and public health experts that develops recommendations on how to use vaccines to control diseases in the United States
bull Specialty providers are not required to offer all routine vaccines but should provide the vaccines appropriate for their population
bull If the site does not offer all routine ACIP-recommended vaccines appropriate for their population check the ldquoNordquo box in Part A then check the appropriate box(es) in Part B for any vaccines not offered Please contact MDH as this situation offers us the opportunity to provide education to the site
bull For non-routine vaccines they must either be in stock or the site must have an alternative protocol in the routine management plan that ensures these children have access when applicable
Resources bull IAC Diseases and Vaccines (wwwimmunizeorgvaccines) bull CDC Advisory Committee on Immunization Practices (ACIP) (wwwcdcgovvaccinesacipindexhtml)
Page 48 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 636 Inventory Separation of Stock
Question 63 Observe how the provider differentiates stock in each storage unit to answer the questions below
A Is it clear which vaccines belong to public stock andwhich belong to private stock
Yes No [X] Not applicable replacement site
B Is it clear which vaccines belong to VFC stock andwhich belong to UUAV stock
Yes No [X] Not applicable replacement site Not applicable not UUAV-enrolled site
Review CDC Requirement
In order to ensure that VFC vaccines are only administered to VFC-eligible children VFC providers that serve both VFC and non-VFCshyeligible children must maintain their vaccine inventories in such a way that they can clearly differentiate public stock from privatestock as well as VFC from other public stock
Goal of this question Assess whether the site can distinguish between MnVFC vaccine and private vaccine If they participate in the Uninsured and Underinsured Adult Vaccine (UUAV) program they should also be able to distinguish between MnVFC stock and UUAV stock Some sites use labels bins boxes etc to differentiate their stock If it is not clear how the site differentiates their stock discuss vaccine management with the staff For follow-up call MDH to discuss doing a follow-up site visit
Sites using the replacement method will not have separate stocksmdashthis is an approved alternative method for keeping track of vaccine
Resource bull Section 10 of the MnVFC Policy and Procedure Manual
IPI Advisor Manual | February 2017 Page 49
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
MnVFC Site Visit Storage and Handling Per Unit Answer Sheet 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet MnVFC PIN ___________________
Question number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
Temperature Monitoring Device Questions Questions 43 47 must be answered separately for the freezer and refrigerator if the unit is a combo Be sure to document responses in the appropriate column
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
All the questions on the Site Visit Storage amp Handling Per Unit Answer Sheet have been discussed previously in section 4 of this manual Use this sheet to record information about all the units at the site visit You will need one sheet for each unit If it is a combination unit (either pharmaceutical or household) you can record both sections on one sheet If they have stand-alone units use one sheet for each unit Do not enter the answers to the questions in section 4 of the questionnaire
If you need more information about any of the questions refer back to the main questionnairemdashthe complete question additional guidance including notes to the reviewer and the CDC requirements are there Also if the site is not meeting the requirement you will go back to the questionnaire to complete the ldquoActions if Non-compliantrdquo section including the root cause analysis and follow-up sections
When you have completed the assessment of all the storage units remember to go back to the questionnaire to complete sections 5 and 6
Page 50 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
ndash
ndash
MnVFC Provider Follow-up PlanThe goal of the Provider Follow-up Plan is to communicate with the site all of the VFC requirements any unmet requirements found during your site visit and the timeline for completing the required action The left hand column is a box to check for ldquoUnmetrdquo requirements
Helpful information bull The form can be used to review what the site is doing well and what they need to work on
bull For requirements that have specific documentation that needs to be sent to you use the notes section
2017 MnVFC Provider Follow-up Plan Site _______________________________________________ MnVFC PIN ____________ Date of Visit ___________
Thank you for participating in this MnVFC compliance site visit Please review this visit summary including follow-up actions and timelines for completion Unmet MnVFC requirements and recommendations have a checked box next to them The goal of this plan is to support you with successfully implementing the program and improving access to vaccines for VFC-eligible children
Unmet Question VFC Requirements Section 1 Changes to Key Staff
Q12 Change in the Medical Director Immunization Manager Vaccine Coordinator or back-upKey Staff must be communicated to the immunization program by emailing healthmnvfcstatemnus Changes Notes
Q12 Key staff must complete the annual training on VFC program requirements and print theAnnual Training certificate of completion Documentation Required Action
Staff that have not completed the MnVFC online training must complete it and send acopy of the certificate to the reviewer Training can be found on the MnVFC website (wwwhealthstatemnusvfc) Due date 1 month
Notes
Unmet Question VFC Requirements Section 2 Eligibility
Q21 Provider staff must possess a working knowledge of all VFC eligibility criteria and use thoseVFC Eligibility criteria to screen children prior to administering VFC vaccines
Categories Notes
bull This form provides documentation needed for follow-up actions when you send your thank you email
The second to last page of the Provider Follow-up Plan has a summary of the MnVFC program recommendations These are to remind the site about best practices they may want to improve upon even though they are not yet requirements of the program For example you could discuss the recommendation about storage units if they currently have a combination household unit and are using both sections
The last section is for your signature and the person you met with In most sites it will be the immunization manager or vaccine coordinator who signs the form unless the medical director attended the site visit You keep the original copy and the site will need to keep a copy for themselves
To be completed by the site visit reviewer
I acknowledge that a VFC site visit was performed on __________________ (visit date) The follow-up plan which includes a list of all current VFC program requirements and recommendations assessed during the visit and any required follow-up actions was provided at the end of the visit
Site visit reviewer
Phone
Reviewer Signature Date
To be completed by the provider
I acknowledge that our practice took part in the VFC site visit noted above I understand the findings of the visit and any required actions that must be taken by our office in order to meet VFC program requirements
Medical Director (or designee) Name Title
Medical Director (or designee) Signature Date
IPI Advisor Manual | February 2017 Page 51
The 2017 MnVFC Site Visit Paperwork Chapter 4
After the Site Visit Send a thank you email highlighting the unmet requirements documents you need from the site to resolve the issue(s) and the date you need them Make sure to include the link to the Site Visit Survey (httpssurveyvovicicomseashxs=56206EE334CE0B14)
Please refer to Chapter 3 for more information about future follow-up required after the visit including forms and documentation
Resource bull Sample Thank You letter on IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml)
Chapter 5
IPI Advisor Resource List MnVFC Program 651-201-5522
MnVFC wwwhealthstatemnusvfc
bull Separate Stock and Replacement Method Policies and Procedures Manuals bull Online trainings bull MnVFC Announcements sign up to receive them via email bull Ordering MDH vaccine bull MnVFC forms Screening forms Reporting forms Others MDH Nonviable Vaccine Form MDH Vaccine Transfer Record and Vaccine Borrowing Report
bull MnVFC promotional materials bull Immunization Billing Guidance for MnVFC and Immunization Billing Guidance for MnVFC Replacement Sites Immunization Practices Improvement Program (IPI) wwwhealthstatemnusdivsidepcimmunizeipi
bull IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml) bull IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml) IPI Resource Folder Contents (wwwhealthstatemnusdivsidepcimmunizeipiipifolderpdf)
Minnesota Immunization Information Connection (MIIC) wwwhealthstatemnusmiic
bull MIIC regions and regional coordinators
Clinical Practice MDH Immunization Program wwwhealthstatemnusimmunize
Got Your Shots News wwwhealthstatemnusdivsidepcnewslettersgys
MDH Immunization Information for Health Care Providers wwwhealthstatemnusdivsidepcimmunizehcp
bull Got Your Shots A Providers Guide to Immunization in Minnesota bull Vaccine protocols bull Forms for tracking patient immunizations bull Immunization schedules for Health Care Providers Immunization Action Coalition (IAC) wwwimmunizeorg
bull Ask the Experts bull VISs (Vaccine Information Statements and translations) bull Administration screening questions bull Medical management of vaccine reactions bull Order form for Californiarsquos Immunization Technique DVD Best Practices with Infants Children and Adults
Page 52 IPI Advisor Manual| February 2017
IPI Advisor Resource List Chapter 5
CDC ldquoPink Bookrdquo wwwcdcgovvaccinespubspinkbookindexhtml
CDC Advisory Committee on Immunization Practices (ACIP) wwwcdcgovvaccinesacip
CDC Vaccines and Immunizations wwwcdcgovvaccines
VAERS reporting httpvaershhsgovindex
Storage and Handling Got Your Shots Providers Guide ndash Managing Vaccine wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml
MnVFC Guide to Temperature Monitoring Devices wwwhealthstatemnusvfc
MDH Clinicianrsquos Vaccine Mishap Checklist wwwhealthstatemnusdivsidepcimmunizeipivaxchklstpdf
MDH Vaccine Storage Guide wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml
CDC Vaccine Storage and Handling Toolkit wwwcdcgovvaccinesrecsstoragetoolkit
You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Vaccine manufacturer phone numbers wwwcdcgovvaccinespubspinkbookdownloadsappendicesFcontact-info-manufactpdf
IAC Checklist for Safe Vaccine Handling and Storage wwwimmunizeorgcatgdp3035pdf
IAC Donrsquot Be Guilty of These Errors in Vaccine Storage and Handling wwwimmunizeorgcatgdp3036pdf
Additional Resources Print materials from MDH ndash order forms wwwhealthstatemnusdivsidepcimmunizeordermathtml
Vaccine Education Center ndash Childrenrsquos Hospital of Philadelphia wwwchopeduservicevaccine-education-centerhomehtml
California Department of Public Health ndash Interactive training on vaccine administration and storage and handling handout on transporting vaccine and how to package wwwezizorg
IPI Advisor Manual | February 2017 Page 53
IPI Advisor Resource List Chapter 5
CDC vaccine price list wwwcdcgovvaccinesprogramsvfcawardeesvaccine-managementprice-listindexhtml
Vaccine Information Statements (VIS) wwwcdcgovvaccineshcpvisindexhtml
CEU Opportunities CDC Immunization Education and Training wwwcdcgovvaccinesedindexhtml
Immunization You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Page 54 IPI Advisor Manual| February 2017
- Introduction
-
- Welcome to the Immunization Practice Improvement (IPI) Program
- Contact Information
-
- Chapter 1
- Requirements to Participate in the MnVFC Program
- Vaccines for Children Program
- Chapter 2
- Reimbursement for MnVFC Visits
- Types of Visits
- Your MnVFC Clinical CoordinatorPlanner
- New IPI Advisor Training Requirements
- Your Role as an IPI Advisor
- Reasons MDH Would Do All or Part of a Visit
- Chapter 3
- Future follow-up
- Conducting the Visit
- Preparing for the Visit
- Information for the Visit
- Site Visit Checklist
- Scheduling the Visit
- Chapter 4
- After the Site Visit
- MnVFC Provider Follow-up Plan
- MnVFC Site Visit Storage and Handling Per Unit Answer Sheet
- Section 6 Inventory
- Section 5 Storage amp Handling Site-Wide
- Section 4 Storage amp Handling Per Unit
- Section 3 Documentation
- Section 2 Eligibility
- Section 1 Provider Details
- The Site Visit Reviewer Legend
- MnVFC Site Visit Questionnaire
- Required Paperwork for Site Visits
- Chapter 5
-
Chapter 4 The 2017 MnVFC Site Visit Paperwork This chapter will go through the required MnVFC site visit paperwork with notes about information or resources to help the site address questions or issues that may arise during the visit
The MnVFC site visit paperwork is available on the IPI Advisor Site Visit Materials (wwwhealthstate mnusdivsidepcimmunizeipisvmaterialshtml) page
Please download the paperwork shortly before your visit as there may be updates and changes and this will be the most up-to-date version of the questionnaire We will send out a Workspace message with major changes
Required Paperwork for Site Visits bull 2017 MnVFC Site Visit Questionnaire bull 2017 MnVFC Storage amp Handling Per Unit Answer Sheet ndash one for each unit assessed during site
visit bull 2017 MnVFC Provider Follow-up Plan ndash with provider signature
Make sure to include the sitersquos PIN on all your paperwork Please complete and submit your site visit paperwork as soon as possible after your visit It may be helpful to schedule some time into your calendar to complete your paperwork in the days following your visit Once you have completed the post-visit follow-up send in the Follow-Up Form with documentation of the follow-up actions Please do not wait until you have completed your follow-up before sending in your initial paperwork
MnVFC Site Visit Questionnaire The questionnaire includes these six sections 1 Provider details 2 Eligibility 3 Documentation 4 Storage amp handling per unit 5 Storage amp handling site-wide 6 Inventory
IPI Advisor Manual | February 2017 Page 17
Page 18 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
The Site Visit Reviewer Legend The legend explains the formatting of the 2017 questionnaire This includes information that will be helpful in completing the site visit
Site Visit Reviewer Guide Legend
Section Number Content Area
Question number This area will always contain the text of the question
Note to reviewer The note to reviewer contains information that is necessary for properly asking and assessing responses tothe question above This may include definitions of terms requirement details and other helpful tips
Answers This field will contain all the possible answer choices for this question For most questions answer choiceswill be followed by the markings below
Answer choices marked with an [X] indicate that this specific answer choice is non-compliant with a CDC requirement Answer choices marked with an [O] indicate that this specific answer choice is not aligned with a CDC
recommendation
Review CDC RequirementRecommendation
This field will be populated with the CDC requirementrecommendation associated with the given question
Actions if Non-Compliant
Root Cause Analysis As part of the site visit reviewers are required to assess and understand the reasons why a provider office isnon-compliant with VFC program requirements ndash this is a root cause analysis Reviewers must choose theone root cause that they believe most contributes to the non-compliance Upon establishing the root causethe reviewer must provide a clear explanation of hisher findings
Immediate Action These are actions that CDC requires reviewers to take on site during the visit
Future Follow-up These are future follow-up actions (with designated due dates) that are required of the reviewer andorprovider to remedy non-compliance Reviewers must complete all follow-up in accordance with CDCestablished deadlines
Notes Information you want the VFC program to be aware of or that explains your answer in detail
bull Note to reviewer These are notes to help you understand what the question is asking for and to clarify things you might want to know when asking or rephrasing the question
bull Answers This section helps you to know when the answer does not meet the CDC requirement [X] or recommendation [O] Whenever an answer with a [X] is checked the ldquoActions if Non-compliant section must be completed The recommendations are usually good teaching points about best practices andor future requirements of the VFC program
bull Review the CDC RequirementRecommendation This section provides a specific outline of the requirement or recommendation to give you information to use in talking with the site staff
bull Actions if Non-Compliant This section describes what to do if the site is not meeting a requirement Root cause analysis This section asks you to probe beyond the surface to find what is driving the non-compliance It is intended to help uncover reasons for recurring non-compliance issues identify additional training needs and inform reviewer follow-up actions Select only one root cause and explain the particular circumstances in the space ldquoExplanation of root causerdquo line provided If there appear to be multiple issues choose the one that most contributes to the non-compliance and describe all factors in the explanation Immediate actions A list of actions to take during the site visit to address the issue Future follow-up A list of actions to take after the site visit by the set deadline
bull Notes This section can be used for notes to yourself or to MDH
IPI Advisor Manual | February 2017 Page 19
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 1 Provider Details Questionnaire Coversheet
The first page of the questionnaire collects the demographic information for the site You can use this page to help prepare for the visit Most of the demographic information about the site should be on the site-specific document you received with your clinic list You will validate that this information is current at the time of the site visit It also helps to know if this is a separate stock site or a replacement site before the visit so you can bring a copy of the appropriate MnVFC Policies and Procedure Manual
2017 MnVFC Site Visit Questionnaire Date of visit _____________ Date forms sent to MDH ______________
Site Information
Site name MnVFC PIN
Address Separate Stock Replacement
City ZIP County
Medical Director Email
Immunization Manager Phone
Vaccine Coordinator Phone
Vaccine Coordinator back-up Email
Point of contact Phone
Personnel at site visit
On this page bull The date of the visit and the date when you send these forms to MDH This information helps us track the timeliness of our review and data entry process
bull The vaccine management method used by the site (replacement or separate stock) bull The name and email of the medical director (ideally this is the person who signed the MnVFC
Program Provider Agreement)bull Contact information for the immunization manager vaccine coordinator vaccine coordinator back-up and point-of-contact for this visit The immunization manager vaccine coordinator vaccine coordinator back-up roles are
described in the MnVFC Policies and Procedure Manual The vaccine coordinator back-up may be the immunization manager or another staff person depending on the size of the site and available personnel The Point of Contact is the person you set up the appointment with signs the Provider Follow-
up Plan and receives the follow-up email This may be one of the people listed above
The Post Visit Steps section is a reminder to you about what needs to done after the visit The Education on Immunization Best Practices for Sites section reminds you to provide the resource folder to the site
Page 20 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 12
1 Provider Details Changes to Key Staff
Question 12 Ask the provider about changes to key staff to answer the questions below
A (Choose all that
apply)
At the time of the visit is the Medical Director the same individual that signed the ProviderAgreement and are the Immunization Manager and Vaccine Coordinator the same asthose last reported to the program
Yes No the Medical Director has changed No the Immunization Manager has changed No the Vaccine Coordinator has changed
B (Choose one)
Were all changes communicated to theImmunization Program according to yourprogramrsquos policy
Yes or no staff changes No [X]
C (Choose one)
Based on review of the trainingdocumentation have the current Immunization Manager Vaccine Coordinator and back-up completed all required training
Yes No [X]
Review CDC Requirement
All changes in key staff must be communicated to the Immunization Program in the manner and timeframe defined by theImmunization Program Key staff include the Medical Director or equivalent who signed the Provider Agreement the Immunization Manager Vaccine Coordinator and the back-up VFC providers are required to ensure that all key staff are fully trained on VFC program requirements at all times All training must be documented
Goal of this question Determine if there are new staff in key positions at the site and to make sure staff are properly educated about the MnVFC program A This information can help you determine the level of knowledge and experience the staff have with the MnVFC program Follow-up throughout the visit can be tailored for various levels of staff experience Likewise you may identify additional training needs for new staff
B When sites notify us of changes in key personnel we update their information in MIIC and on the clinic lists We also send the new staff information for completing the online training and direct them to read the appropriate MnVFC Policies and Procedures Manual If the answer to this part is no update the demographic area of the questionnaire and inform the staff that in the future they must notify the MnVFC program (via email or phone) if the immunization manager or vaccine coordinator changes Resource Section 12 of the MnVFC Policies and Procedures Manual
C Annual training must be verified by looking at the certificates for the online training If the answer to this part is no refer the staff to complete the appropriate MnVFC online training found on the MnVFC website (wwwhealthstatemnusvfc) for their program (separate stockreplacement) for the current year and send you a copy of the certificate within 30 days
Resource bull Sections 12 and 14 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 21
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 2 Eligibility Question 21
Goal of this Question Assess whether staff correctly understand which patients are eligible for the MnVFC program Screening ensures that eligible children receive the vaccines that they are entitled to receive under the MnVFC program and helps to prevent fraud or abuse of the program
Children 18 years and younger in these
categories can receive MnVFC vaccine at any enrolled site bull Uninsured bull Enrolled in a Minnesota Health Care Program (MHCP) Medical Assistance (MA) or MinnesotaCare bull American Indian or Alaskan Native
The following categories are considered underinsured and are only MnVFC-eligible at local public health (LPH) Federally Qualified Health Centers (FQHC) Rural Health Centers (RHC) Indian Health Services (IHS) and tribal health clinics
bull Has health insurance that does not cover one or more vaccines as can be the case with newly licensed vaccines that arenrsquot yet covered (MnVFC-eligible for non-covered vaccines only)
bull Has health insurance that caps vaccine coverage at a certain amount Once that amount is reached the child is MnVFC-eligible
Children with insurance that does not cover vaccines until a deductible has been met are considered to be fully insured and are not MnVFC-eligible
Helpful information bull Sites are not required to verify the patientrsquos response to the screening questions For example if a patient states they lost their insurance the site does not need to call the patientrsquos insurance company to confirm
If the site cannot correctly describe the eligibility categories provide educational materialsresources on MnVFC eligibility requirements
Resources bull Patient Eligibility Screening Record on MnVFC Forms (wwwhealthstatemnusdivsidepc immunizemnvfcformshtml)
bull Section 1 of the MnVFC Policies and Procedures Manual
2 Eligibility VFC Eligibility Categories
Question 21 Was the individual responsible for determining patient VFC eligibility able to explain all the factors(including age) that make a child eligible to receive VFC vaccines
A Patient is less than 19 years of age Yes No [X]
B Patient is Medicaid-eligible Yes No [X]
C Patient is uninsured Yes No [X]
D Patient is underinsured Yes No [X]
E Patient is American Indian Yes No [X]
F Patient is Alaska Native Yes No [X]
Review CDC Requirement
VFC providers must possess a working knowledge of all VFC eligibility criteria and use those criteria to screen children prior toadministering VFC vaccines In order to receive VFC vaccine a patient must be under the age of 19 and must be at least one of the following (1) Medicaid-eligible (2) Uninsured (ie child has no health insurance) (3) Underinsured (ie child has health insurancebut coverage does not cover any or certain vaccines ndash underinsured children may only receive VFC vaccines in FQHCRHC ordeputized VFC provider offices and only for vaccines not covered by insurance) and (4) American Indian or Alaska Native (AIAN)
Page 22 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 22
2 Eligibility Billing Practices
Question 22 Is the individualdepartment responsible for billing able to clearly explain how they bill for both the costof vaccine and the vaccine administration fee for each of the eligibility categories below
A Medicaid-eligible Cost of Vaccine Do not bill ndash provided by VFC Admin Fee Bill Medicaid
Yes No [X]
B Uninsured Cost of Vaccine Do not bill ndash provided by VFC Admin Fee If billing can bill patient
Yes No [X]
C Underinsured Cost of Vaccine Do not bill ndash provided by VFC through FQHCsRHCs or deputized providers only all other providers cannotprovide VFC vaccine to underinsured patients Admin Fee If billing can bill patient
Yes No [X]
D American IndianAlaska Native(AIAN)
Cost of Vaccine Do not bill - provided by VFC unless patient is fully insured and parent chooses to use insurance Admin Fee If patient is Medicaid-eligible bill Medicaid if billingand patient is uninsuredunderinsured can bill patient if parentchooses to use private insurance for cost of vaccine billpatientinsurance
Yes No [X]
E Do individuals responsible for billing have access to the results of eligibility screening toensure proper billing
Yes No [X]
Review CDC Requirement
VFC providers must adhere to proper billing practices for vaccine administration fees and clearly understand that VFC vaccine isprovided at no cost to both the VFC provider and eligible children At no time should billing occur for the cost of VFC vaccine Whenadministering VFC vaccine providers should never bill two different ldquopayersrdquo (ie patient Medicaid insurance) for the samevaccine administration fee amount For Medicaid-eligible children Medicaid should be billed for the vaccine administration fee Forall other VFC-eligible populations the patient may be billed within the stateterritory cap established by the Centers for Medicareand Medicaid (CMS) However patients cannot be turned away or reported to collections for inability to pay the administration fee
Goal of this question Determine if the staff correctly understand how to bill patients that are eligible for the MnVFC program Billing appropriately ensures that children can receive low cost immunizations and the site is in compliance with the VFC program
bull If there is any indication that sites could be billing insurance companies or parents for VFC vaccines this should be investigated further
bull Most sites in Minnesota will bill Medicaid with the SL modifier ndash which indicates this is a Medicaid claim
bull The main point is to ensure the site is not billing uninsured children for VFC vaccine and are not charging them more than $2122 per vaccine for the administration fee
bull Non-compliance is usually unintentional and may be resolved with some training In rare cases it could be a glimpse into a larger problem where a site is intentionally billing for financial gain
bull If you think the site is billing inappropriately it is the responsibility of the IPI advisor to report concerns to MDH staff for further assistance
Resources bull Immunization Billing Guidance for MnVFC (wwwhealthstatemnusdivsidepcimmunizemnvfc billingtipshtml) or Immunization Billing Guidance for MnVFC Replacement Method Sites (www healthstatemnusdivsidepcimmunizemnvfcreplacementbillingtipsrephtml)
bull Section 2 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 23
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 232 Eligibility Vaccine Administration Fee
Question 23 Document the actual vaccine administration fee charged to non-Medicaid VFC-eligible patients (confirmwith billing department)
Answers Fee $ [X] Follow-up is required if the provider charges more than the fee cap establishedby the Centers for Medicare and Medicaid (CMS) for your stateterritory ($2122)
Review CDC Requirement
The VFC providerrsquos vaccine administration fee for non-Medicaid VFC-eligible children must not exceed the stateterritory vaccineadministration fee cap established by the Centers for Medicare and Medicaid (CMS) For current fee caps refer to Medicaid Program Payments for Services Furnished by Certain Primary Care Physicians and Charges for Vaccine Administration Under theVaccines for Children Program Final Rule (httpwwwgpogovfdsyspkgFR-2012-11-06pdf2012-26507pdf)
Goal of this question Ensure that sites are not charging more than the federal allowable vaccine administration fee of $2122
bull The Centers for Medicaid and Medicare (CMS) establishes a maximum fee that sites can charge to non-Medicaid-eligible VFC patients in each stateterritory for vaccine administration Health Plans usually negotiate this fee with the site but Medicaid will not pay more
bull If a parent cannot pay the vaccine administration fee the patient cannot be turned away or reported to collections VFC-eligible children must be vaccinated regardless of their ability to pay
bull If the person with whom you are conducting the site visit does not know the exact fee charged to non-Medicaid VFC-eligible patients ask to speak to someone who can verify the exact amount
bull If they are charging more than $2122 for the administration fee ndash please contact MDH staff for help with addressing this situation
Resources bull Immunization Billing Guidance for MnVFC (wwwhealthstatemnusdivsidepcimmunizemnvfc billingtipshtml) or Immunization Billing Guidance for MnVFC Replacement Method Sites (www healthstatemnusdivsidepcimmunizemnvfcreplacementbillingtipsrephtml)
bull Section 2 of the MnVFC Policies and Procedures Manual
Page 24 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 3 Documentation Question 31
3 Documentation Eligibility Screening amp Documentation
Question 31 To answer the questions below the provider must clearly demonstrate the patient intake processReview a minimum of 10 records that contain an immunization visit within the last 6 ndash 12 months
Note to Reviewer Criteria for Record Selection 1) Record selection must be completely random and the provider must not know prior to the visit which
records will be reviewed 2) Patient must have been 0-19 years of age at the last visit (Note Records of 19-year-old patients may
allow you to see if VFC vaccines are being used beyond the allowable age) 3) Must review a mix of public and private-pay patients (if applicable)
A Does the provider have a process that ensures that patients are screened forVFC eligibility at each visit and that screening results are documented at each visit
Yes No [X] (If no skip question F)
B Does the providerrsquos process ensure that staff administering vaccine know which vaccine stock to select from prior to drawing the vaccine
Yes No [X]
C Number of records reviewed If fewer than 10 records are reviewed select the reason why Provider does not have 10 patient records with immunizations in last 12 months
D Do all records contain date of the immunization visit and patientrsquos date of birth Yes No [X]
E Do all records contain the patientrsquos specific eligibility status associated with thedate of the immunization
Yes No [X]
F Do any of the providerrsquos records contain any evidence that the patient received vaccine for which they were not eligible
Yes [X] No
Review CDC Requirement
VFC providers must screen for and document VFC eligibility at each immunization visit Documentation must include the date of the visit and the childrsquos specific eligibility category VFC providers must use screening results to ensure that only VFC-eligible children receive VFC vaccine and that administration fees are billed for as appropriate Eligibility status must be readily available to staff administering vaccine prior to selecting which vaccine stock to use
Goal of this question Ensure the site is screening for eligibility and documenting the eligibility category in the medical record
Review a minimum of 10 records from within the last 6-12 months where the patient received an immunization You must review a mix of public and private pay patients (if applicable)
Random selection is important If the staff have pre-selected records for review do not use and identify additional randomly selected records to review
Helpful information bull Discuss upgrading the electronic health record to make documentation of VFC eligibility screening a required field Documenting eligibility screening in the immunization field promotes better MIIC data
bull Q 31 B Sites using the replacement method of vaccine management only have one stock so you will answer ldquoYesrdquo to this question
Resources bull Patient Eligibility Screening Record on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfcformshtml)
bull Section 1 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 25
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 32
3 Documentation Vaccine Dose Documentation
Question 32 Review a minimum of 10 patient immunization records from the last six months (or 12 months ifnecessary) to assess compliance with documentation requirements set forth by Statute 42 US Code 300aa-25 (See note to reviewer below)
Note to Reviewer Criteria for Record Selection 1) Record selection must be completely random the Provider must not know prior to the visit which records
will be reviewed 2) Patient must have been 0-19 years of age at the last visit (Note Records of 19-year-old patients may allow
you to see if VFC vaccines are being used beyond the allowable age)
Records are Compliant if they Contain ALL the Below Elements
bull Address of clinic where vaccine was administered bull Publication date of VIS bull Name of vaccine administered bull Name of vaccine manufacturer bull Date vaccine was administered bull Lot number bull Date VIS was given bull Name and title of person who administered the
vaccine
A Number of records reviewed
B Number of records that contain ALL required documentation elements
If fewer than 10 records are reviewed select the reason why Provider does not have 10 patient records with immunizations in last 12 months
[X] Follow-up isrequired if one ormore records do not meet requirements
Goal of this question Assess whether the site is documenting all required information in each patientrsquos medical record for every vaccine dose administered in accordance with the National Childhood Vaccine Injury Act
Resources bull Section 6 of the MnVFC Policies and Procedures Manual bull National Vaccine Injury Compensation Program (wwwhrsagovvaccinecompensation)
Question 33
3 Documentation Record Retention
Question 33 Is the provider able to demonstrate (preferred) or clearly describe how they maintain historical VFCeligibility documentation for three years
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers are required to maintain all records related to the VFC program for a minimum of three years (or longer if requiredby state law) and upon request make these records available for review VFC records include but are not limited to VFC screening and eligibility documentation billing records medical records that verify receipt of vaccine vaccine ordering records and vaccinepurchase and accountability records
Goal of this question Make sure the site understands they are required to keep all MnVFC screening documentation for at least three years either electronically or on paper This information should be available to you at the time of the visit and future visits
Resource bull Section 7 of the MnVFC Policies and Procedures Manual
Page 26 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 34
3 Documentation Borrowing Documentation
Question 34 Discuss borrowing practices with the provider to answer the questions below
Note to Reviewer bull To be considered ldquofully documentedrdquo documentation for each borrowed dose must include thefollowing information
Vaccine type borrowed Date the dose was administered Stock used (VFC or private) Reason appropriate vaccine stock was not used Patient name and date of birth Date dose was returned to appropriate stock
A Did the provider state that they had borrowed any vaccines (whetherdocumented or not) since the last VFC Compliance Site Visit
Yes No (If no skip to question 36)
B Are there any doses for which there is no documentation (ie provider hasindicated that doses were borrowed but cannot verify how many or why)
All doses are documented Some doses are not documented [X] No doses are documented [X] (if nodoses documented skip toquestion 36)
C Were all borrowed doses fully documented (See Note to Reviewer above) Yes No [X]
D Were all borrowed VFC doses either replaced or an order submitted to replacethe doses Yes No [X]
Review CDC Requirement
VFC providers are expected to maintain an adequate inventory of vaccine for VFC and non-VFC-eligible patients It is theresponsibility of the VFC provider to appropriately schedule and place vaccine orders VFC providers must also rotate stock to ensure timely use of short-dated vaccines Borrowing of vaccine between private and public inventories must be a rare unplanned occurrence and cannot serve as a replacement system for a VFC providerrsquos privately purchased vaccine inventory All instances ofborrowing must be properly documented reported and replaced
Goal of this question Assess vaccine accountability by verifying that children are receiving vaccine from the appropriate stock
Borrowing is when a fully insured child receives a dose of MnVFC vaccine or a MnVFC-eligible child receives a dose of private vaccine This should be a rare unplanned occurrence The site must document any borrowing of vaccine between stocks ideally on the VFC Borrowing Report Form If they are not currently using the form review it with them and encourage them to post it close to their vaccines It does not need to be sent to MDH but should be kept for 3 years and filed with their MnVFC documents to be reviewed whenever they have a regular or unscheduled (unannounced) site visit
Helpful information bull Understand and report on staffrsquos verbal (ie anecdotal) accounts of borrowing obtained during the visit Often sites do not know that what they do is considered borrowing or they think borrowing is acceptable and documentation isnrsquot needed so long as those vaccines are eventually replaced
bull Since sites using the replacement method only have one stock of vaccine they very rarely borrow bull This question asks for future follow-up in 6 months Make a note on your calendar and ask them to send you a copy of their borrowing reports for the previous 6 months with documentation of doses borrowed and replaced We will remind you if we donrsquot hear from you at the 6 month time frame Complete the Follow-up Form and attach the borrowing form
Resources bull Vaccine Borrowing Report on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfc formshtml)
bull Section 10 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 27
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 353 Documentation Borrowing Reasons
Question 35 Based on your discussion with the provider and a review of borrowing reports document the dosesborrowed for each reason and answer the questions below
Note to Reviewer bull Short-dated vaccines are doses that are likely to expire before they can be used bull Exchanging short-dated vaccines should only occur in practices that have a small number of private
patients
A Reasons for Borrowing a VFC Dose (Enter the number of _____ Private vaccine shipment delay (order placed on time but delay in shippingreceipt)
vaccine doses borrowed for each
reason in the spaces
_____ Private vaccine not useable on arrival (vials broken temperature monitor out of range) _____ Ran out of private vaccine between orders (provider orders not placed on time) [X]
provided) _____ Short-dated private dose was exchanged with VFC stock _____ Accidental use of VFC dose for a private patient (human error) _____ Replacement of private dose with VFC when insurance plan did not cover vaccine _____ OtherDocumented dose did not include reason for borrowing [X]
(Explanation Required) Reasons for Borrowing a Private Dose _____ VFC vaccine shipment delay (order placed on time but delay in shippingreceipt) _____ VFC vaccine not useable on arrival (vials broken temperature monitor out of range) _____ Ran out of VFC stock between orders (provider orders not placed on time) [X] _____ Short-dated VFC vaccine dose was exchanged with private dose _____ Accidental use of a private dose for a VFC-eligible patient (human error) _____ OtherDocumented dose did not include reason for borrowing [X]
(Explanation Required)
B Enter date range for instances of borrowing reviewed in the borrowing report Note If ldquoDate of earliest instancerdquo is not available use the date of the last VFC Compliance Visit If ldquoDate of last instancerdquo is not available use the date of thecurrent VFC Compliance Visit
Date of earliest instance
Date of last instance
C Does borrowing appear to be a routine practice Note To determine whether borrowing is a routine practice assess frequency of and repeating reasons for borrowing Examples Frequent accidental use of incorrect stock exchanging short-dated vaccines or issues with ordering and shipment
Yes [X] No
Goal of this question Determine the reasons why the site is borrowing vaccine
If sites are using the Vaccine Borrowing Report review the reasons for borrowing to help document borrowed VFC andor private doses If they have not been documenting borrowing on this report (or any other form) estimate their borrowing practices If you do not know the date range for their borrowing use the last site visit date to the current visit date The use of ldquootherrdquo as the reported reason for borrowing should be rare if ever and would require explanation and follow up
Helpful information bull Look to see if they routinely maintain insufficient amounts or types of vaccine to support their public and private patients that leads to borrowing
bull Pay attention to borrowing cases documented as ldquoaccidentalrdquo Repetitive accidental borrowing may indicate an issue with ordering processes or insufficient staff training
bull Borrowing is not a place to document wasted or lost doses bull The time period of the borrowing may give you clues about the root cause Were the borrowed doses concentrated in a short period or spread out across several months or a year Are all vaccine types being borrowed or just one
bull If borrowing seems to be an issue discuss vaccine management ordering procedures
Resources bull Vaccine Borrowing Report on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfc formshtml)
bull Section 10 in the MnVFC Policies and Procedures Manual
Page 28 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 36
3 Documentation Vaccine Management Plan
Question 36 Physically review the providerrsquos Vaccine Management Plan to answer the question below
A Does the provider have a Vaccine Management Plan Yes No [X] (If no skip to question 37)
B Does the plan list the current Immunization Manager Vaccine Coordinator andback-up
Yes No [X]
C Does the plan address proper vaccine storage and handling practices Yes No [X]
D Does the plan specify vaccine receiving procedures Yes No [X]
E Does the plan contain procedures for what to do with vaccine in the event of an emergency
Yes No [X]
F Does the plan contain procedures for vaccine ordering Yes No [X]
G Does the plan address inventory control (example stock rotation) Yes No [X]
H Does the plan address how to handle vaccine wastage Yes No [X]
I Does the plan address staff training and documentation on vaccine managementstorage amp handling
Yes No [X]
J Does the plan contain a review date that falls within the last 12 months Yes No [X]
K Has the plan been signed by the individual responsible for its content Yes No [X]
Review CDC Requirement
VFC providers must develop maintain and implement a Vaccine Management Plan for routine and emergency vaccinemanagement The plan must contain the current Vaccine Coordinator and back-up proper storage and handling practicesshipping and receiving procedures emergency procedures procedures for vaccine ordering inventory control (eg stock rotation)how to handle vaccine wastage and staff trainingdocumentation on vaccine management storage and handling The plan must bereviewedupdated annually or more frequently if changes occur A ldquoreview daterdquo and signature are required on all plans in order tovalidate that they are current
Goal of this question Evaluate the sitersquos plan for vaccine management It is especially important that they have a plan for emergency management of their vaccine in the case of equipment failure or power outage Encourage all sites to read and sign the MnVFC Policies and Procedures Manual and complete the emergency plan or be able to show you a plan of their own
If the provider is not able to physically show you the plan at the time of the visit or if the recorded review date is not within the last 12 months you must mark that this requirement is unmet The Vaccine Management Plan is important in times of emergency and it should be easy to access by any staff member at any time Encourage them to post the plan and put a copy with the packing supplies
Helpful information bull Encourage the site to fill in the ldquoImmunization Managerrdquo and ldquoVaccine Coordinatorrdquo fields in the
MnVFC Policies and Procedures Manual for their own referencebull The emergency plan in the manual can be reviewed from last year and included in this yearrsquos manual (with an updated signature and date) if there have not been any changes
bull If information in the plan is outdated site staff will not be well equipped to safely manage vaccines in the event of a power-outage or other emergency situation
bull If their institutional policy is only reviewed and updated every 3-4 years (as many are) the staff may need to sign the MnVFC Polices and Procedure Manual to meet this requirement
Resource Routine Vaccine Management Plan and Emergency Vaccine Management Plan in the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 29
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 37
3 Documentation VIS amp VAERS
Question 37 Review the providerrsquos Vaccine Information Statements (VISs) and discuss providerrsquos VAERS process toanswer the questions below
A Does the provider have readily available up-to-date VISs for all ACIP-recommendedvaccines relevant to the populations it serves
Yes No [X]
B Does the provider make a VIS available for patientsparents before eachvaccination
Yes No [X]
C Does the provider know how and when to report clinically significant adverseevents using VAERS
Yes No [X]
Review CDC Requirement
VFC providers are required to distribute the current Vaccine Information Statements (VIS) each time a vaccine is administered and maintain records in accordance with the National Childhood Vaccine Injury Act (NCVIA) which includes reporting clinicallysignificant adverse events to the Vaccine Adverse Event Reporting System (VAERS) For a list of current VISs visit CDCrsquos Vaccine Information Statements (httpwwwcdcgovvaccineshcpvis) website
Gal of this question Ensure the site has the most current VISs and is giving them to each patientparent before administering the vaccine in compliance with the federal law Parents must be educated about the vaccine their child will receive and be aware of possible contraindications and side-effects in order to make well-informed decisions about their childrsquos health
Helpful information bull Ask to see the sitersquos VISs to determine if they have an active protocol for giving VISs to parents Review to make sure they are current Ask if they know where and how to report vaccine adverse events
Resources bull Section 3 in the MnVFC Policies and Procedures Manual bull CDC Vaccine Information Statements (wwwcdcgovvaccineshcpvisindexhtml) Site may sign up for email updates for the current list of VIS publication dates for the most up-to-date version
bull IAC Itrsquos Federal Law You must give your patients current Vaccine Information Statements (wwwimmunizeorgcatgdp2027pdf)
bull VAERS (httpsvaershhsgovindex)
Question 38
3 Documentation Anaphylaxis protocol
Question 38 Does the site have an anaphylaxis protocol which is clearly posted near the emergency kit
Answers (Choose one)
Yes No [X]
Review CDC Requirement
An anaphylaxis protocol must be clearly posted in the area where vaccines are administered
Goal of this question Make sure site is prepared for a severe allergic or anaphylactic reaction to a vaccine
Resources bull Section 11 in the MnVFC Policies and Procedures Manual bull IAC protocols Child and Teens (wwwimmunizeorgcatgdp3082apdf) and Adults (wwwimmunize orgcatgdp3082pdf)
Page 30 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
i
i i i - li i i i i i l
Section 4 Storage amp Handling Per Unit The goal of this section is to assess vaccine storage
2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet practices in each unit at the site MnVFC PIN ___________________
The 2017 MnVFC Storage amp Handling Per Unit Answer Sheet is a worksheet to document the answers to the questions in this section for each unit (combination or stand-alone) Fill in the answers to the questions in Section 4 on the answer sheet not in the questionnaire
The answer sheet has an abbreviated form of each question If you need further information on that question refer back to the full questionnaire Also if you find an area where the site is not meeting the requirements you will need to go back to that question on the 2017 MnVFC Site Visit Questionnaire to complete ldquoActions if Non- compliantrdquo section including the root cause analysis and follow-up sections If there is a problem in more than one unit make a note on the questionnaire which unit you are referring to in the Notes section
Important You must fully assess any unit that may be used to store VFC vaccines even if there are no VFC vaccines there on the day of the visit If there are no vaccines and the site is not documenting twice a day temperatures discuss the need to ensure the unit is maintaining stable temperatures by monitoring for one week before placing vaccines in the unit
Quest on number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
for the freezer and e co umn
Temperature Monitoring Dev refr gerator f the un
ce Quest ons Quest ons 4 3 4 7 must be answered separate y t s a combo Be sure to document responses n the appropr at
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
44D Data downloaded and reviewed routinely (eg weekly)
Yes No [O]
Yes No [O]
45A Certificate of Calibration Testing Yes No [X]
Yes No [X]
45B Date of calibration
45C Date certificate expires [X] Follow-up is required if expired [X] Follow-up is required if expired
45D Certificate contains all necessary items
Yes No [X]
Yes No [X]
46 Probe properly placed Yes No [X]
Yes No [X]
47A Two temperature readings per day
Yes No [X]
Yes No [X]
47B Time date and name (or initials) for each reading
Yes No [X]
Yes No [X]
47C Current temperature and minmax temperatures (if
Current ________deg Minimum ________deg Maximum _deg
Current ________deg Minimum ________deg Maximum _deg
Sections 5 and 6 contain questions about storage and handling site wide and inventory It is helpful to keep those questions in mind as you assess the individual storage units Think about dorm-style units expired vaccine vaccine supply room for vaccine stocking all the recommended vaccines and separation of stock if appropriate
NOTE The sections that follow require reviewers to validate responses by looking at vaccine storage units temperaturemonitoring equipment and the vaccine inventory inside a unit bull For section 4 use a separate Storage amp Handling Per Unit Answer Sheet for each unit to document the findings (combination
units using both sections can be documented on the same answer sheet) bull When an unmet requirement is identified return to this questionnaire to complete the ldquoActions if Non-compliantrdquo section for
that question bull After you complete one answer sheet for each unit return to the questionnaire to complete sections 5 and 6 using information
you gathered while assessing the units The questions in sections 5 and 6 (Storage amp Handling Site-Wide and Inventory) are notunit-specific but do require that the response be based on a thorough assessment of all the providersrsquo units
4 Storage amp Handling Per Unit
Description On the Storage amp Handling Per Unit Answer Sheet place a name that will allow you or someone else from your program to easily identify this unit in the event of follow-up We recommend using Brand + Location(example Samsung - Room 123) Save each Storage amp Handling Per Unit Answer Sheet with the Brand + Location in the file name
(example SamsungRoom123doc)
IPI Advisor Manual | February 2017 Page 31
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 41
4 Storage amp Handling Per Unit Storage Unit Build amp Use
Question 41 Below select the build and use of the vaccine storage unit you are assessing
Note to Reviewer Dorm-style units Do not add dorm-style units here Dorm-style units will be addressed in section 5 Units storing only private stock You must review these storage units even if they contain only private stockat the time of the visit because that vaccine could be administered to VFC patients
A What type of unit is this A Stand-alone B Combination
B Select use if stand-alone A Freezer B Refrigerator
Select use if combination A Use both sections to store vaccine B Use freezer section only to store vaccine C Use refrigerator section only to store vaccine
Goal of this question Identify the unit you are evaluating The description asks you to create a unique name for this unit so that you will be able to identify the same unit in future site visits Put this description on the top of the answer sheet (ie make and location)
Helpful information bull A stand-alone unit is either a refrigerator or a freezer It does not have both sections in the unit bull If there is a combination unit note if the site uses both the refrigerator and freezer or only one section of the unit to store vaccines CDC does not recommend the use of either section or the freezer section only of combination household units
bull If your site utilizes the separate stock method of vaccine management you must review storage units even if they contain only private stock at the time of the visit because there is a chance that those vaccines could be administered (borrowed) to VFC-eligible patients
Page 32 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 424 Storage amp Handling Per Unit CDC Recommended Storage Units
Question 42 Below document the grade of the vaccine storage unit you are assessing
Note to Reviewer Pharmaceutical Also called ldquopurpose-builtrdquo these units are designed by the manufacturer specifically tostore vaccines or other biological materials Commercial Although usually intended to store food and beverages commercial units are often larger and more powerful than the household units found in most homes Though these units are intended to meet thehigher demands of larger facilities these units are not specifically built for the storage of biologicalmaterials Household (non-commercialdomestic) These units are usually smaller than commercial units and areintended for use in small offices and in homes ndash typically for food storage However just like commercialunits they are not designed specifically for the storage of biological materials Such units are usually available in common home supply stores
Answers (Choose one)
Select grade A Pharmaceutical B CommercialHousehold
[O] CDC does not recommend the use of both sections or the freezer section only of combination commercialhousehold units
Review CDC Recommendation
CDC recommends the following vaccine storage unit types (in order of preference) pharmaceutical grade stand-alone orcombination units (preferred) householdcommercial stand-alone units householdcommercial combination units using therefrigerator section only
Goal of this question Assess the grade and type of each storage unit bull Pharmaceutical grade units may be stand-alone or combination units that are often metal may have glass in the door for viewing inside often have an external digital temperature display and are manufactured by medical companies
bull Commercial or household units often look like your kitchen appliance have vegetablemeat drawers in the unit and are manufactured by household appliance companies
bull Occasionally you might find a medical grade unit which is usually a commercialhousehold unit with a lock and 3-prong plug These are still considered household units because of their ability to maintain proper temperatures and air flow Studies show that household stand-alone units are better able to maintain consistent temperatures than their combination counterparts Combination household units used to store vaccine in both sections of the unit is no longer recommended and may be prohibited in the future Combination household storage units that are having difficulty maintaining a cold enough freezer temperature and a warm enough refrigerator temperature should be replaced or a separate stand-alone freezer should be purchased
For frozen vaccines the most cost effective solution is for the site to purchase a small stand-alone freezer The site may need time to budget for a stand-alone storage unit
Resources bull Replacing Combination Household Units Tip Sheet on IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml)
IPI Advisor Manual | February 2017 Page 33
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 434 Storage amp Handling Per Unit Temperature Monitoring Device in the Unit
Question 43 Determine whether there is a temperature monitoring device in this section of the storage unit andanswer the questions
A Is there a temperature monitoring device in this section of thestorage unit
Yes No [X] (If no skip to question 47)
B Who is responsible for supplying the temperature monitoring device in this section of the storage unit Provider
Review CDC Requirement
Certificates of calibration testing provide confidence that the temperature monitoring device is measuring temperaturesaccurately All units storing VFC vaccines must have a calibrated temperature monitoring device with a current and valid certificateof calibration testing All certificates must contain modeldevice name or number serial number date of calibration testing (report or issue date) and Instrument Passed testingInstrument in Tolerance (Recommended uncertainty = +-05ordm C (+-1ordm F))
Goal of this question Assess whether there is a temperature monitoring device in the unit If the unit is not being monitored at all call MDH at 651-201-5522 for guidance
Helpful information bull This question does not ask whether the temperature monitoring device is working or the characteristics of the device These issues will be addressed later in the questionnaire
bull For part B the provider is always responsible for supplying the temperature monitoring device Even if their thermometer or data logger was originally from MDH it is their responsibility to ensure it is functional and calibrated
Resources bull Section 8 in the MnVFC Policies and Procedures Manual
Page 34 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 444 Storage amp Handling Per Unit CDC Recommended Temperature Monitoring Device
Question 44 Assess the temperature monitoring device in this section of the storage unit to answer the questionsbelow
A Is the temperature monitoring device a continuous monitoring and recordingdevice (eg data logger)
Yes No [O] (Skip D)
B Does the temperature monitoring device have a probe in buffered material Yes No [O]
C Does the temperature monitoring device have a digital display that can beeasily read from the outside of this unit
Yes No [O]
D Is data downloaded and reviewed routinely Yes No [O]
Review CDC Recommendation
As of Jan 1 2018 all VFC providers must use continuous temperature monitoring devices (eg data loggers) to monitor vaccinesthat will be administered to VFC-eligible children Routine review and accessibility of temperature data is critical for determining whether vaccine has been properly stored and for assessing usability of vaccine that was involved in a temperature excursion Tomeet VFC Program requirements the device must also be equipped with bull A temperature probe bull An active temperature display that can be easily read from the outside of the unit bull The capacity for continuous monitoring and recording capabilities where the data can be routinely downloaded
The following are additional recommended features for these devices bull Alarm for out-of-range temperatures bull Current minimum and maximum temperatures display bull Low battery indicator bull Accuracy of +- 1degF (05degC) bull Memory storage of at least 4000 readings bull User programmable logging interval (or reading rate) recommended at a maximum time interval of every 30 minutes bull Use of a probe that best reflects the temperature of the vaccine (such as a buffered probe)
Goal of this question Assess the temperature monitoring device in the storage unit Note that these are all recommendations not requirements at this time
This is a great teaching opportunity for sites who do not currently have a continuous temperature monitoring device Beginning Jan 1 2018 all units that store MnVFC vaccine will be required to have a continuous temperature monitoring device (ie a data logger or a continuous temperature monitoring system) Unlike a minmax thermometer a continuous temperature monitoring device provides detailed information on all temperatures recorded at pre-set intervals For excursions it can provide information on when a temperature went out-of-range for how long and what the temperatures were This is essential information that vaccine manufacturers need to know to assess the viability of the vaccine following an excursion
Helpful information bull Sites are required to monitor and record temperatures twice daily however temperature excursions can easily occur in the 12 hours or longer between readings Continuous temperature monitoring can help manufacturers determine vaccine viability
bull Continue to encourage sites to document and evaluate minimum and maximum temperatures the storage unit reached since the last reading and respond appropriately to out-of-range temperatures
IPI Advisor Manual | February 2017 Page 35
The 2017 MnVFC Site Visit Paperwork Chapter 4
bull It is recommended that sites download and review data weekly Discuss with sites that reviewing temperature monitoring device data also includes responding appropriately if they identify out-of-range temps
bull There is sometimes confusion about the difference between a data logger and a continuous temperature monitoring system Here are some differences
Data Loggers Continuous Monitoring Systems Have an external display similar to thermometers May or may not have an external display Have a detachable probe Probe is usually attached to transmitter Need to be plugged into the computer or cradle to download information on a regular schedule
Wirelessly sends data to computer system
Create a file of data that needs to be saved on the computer
Data is stored within the system not a separate file
Doesnrsquot allow documentation of twice a day temperature checks in the file
May allow documentation of twice a day temperature checks within the system
More about the 2018 requirement for a continuous temperature monitoring device
Required Features bull The continuous temperature monitoring device must have Continuous monitoring and recording capabilities to track and record temperatures over time The capacity to routinely download temperature data to a computer (recommended at least weekly) or wirelessly transmit data Detachable probe in a bottle filled with a thermal buffer (eg bio-safe glycol) if the data logger needs to be detached in order to download data Active temperature display
Recommended Features bull MnVFC recommends continuous temperature monitoring devices with Alarm for out-of-range temperatures Accuracy within +-1degF (+- 05degC) Low battery indicator Display of current minimum and maximum temperatures Memory storage of at least 4000 readings User programmable logging intervals (eg the user can set how often the device records the temperature)
Note that these are all currently recommendations not requirements yet
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Page 36 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 45
Goal of this question Ensure the temperature monitoring device is properly calibrated The certificate of calibration testing means that the device has been tested and it is accurately measuring temperatures within established testing limits The certificate of calibration ensures that the device meets all the required components
Helpful information bull The provider is always responsible for having a current certificate of calibration (or copy) on-site
bull To be considered ldquovalidrdquo a certificate of calibration must contain these required elements Modeldevice name or number Serial number
4 Storage amp Handling Per Unit Certificate of Calibration Testing
Review CDC Requirement
Certificates of calibration testing provide confidence that the temperature monitoring device is measuring temperaturesaccurately All units storing VFC vaccines must have a calibrated temperature monitoring device with a current and valid certificateof calibration testing All certificates must contain modeldevice name or number serial number date of calibration testing (report or issue date) and Instrument Passed testingInstrument in Tolerance (Recommended uncertainty = +-05ordm C (+-1ordm F))
Question 45
Note to Reviewer
A
B
C
D
E
Review the certificate of calibration testing for the temperature monitoring device in this section of the storage unit and answer the questions below
bull How to determine certificate of calibration testing expiration date 1) Identify the certificate issuecalibration date 2) Apply the Immunization Program-required frequency for calibration testing Example If the
issuecalibration date is 12312013 and Immunization Program policy requires testing every twoyears the expiration date is 12312015
bull Certificates must include all of the below bull ModelDevice Name or Number bull Serial Number bull Date of Calibration Testing (Report or Issue Date) bull Instrument Passed testing (Instrument in Tolerance)
Is there a certificate of calibration testing for the temperature monitoring Yes device in this section of the storage unit No [X]
What is the date of calibration for the temperature monitoring device in this section of the storage unit
What is the certificatersquos date of expiration based on ImmunizationProgram policy (See note to reviewer to determine expiration date) [X] Follow-up is required if
certificate is expired
Does the certificate contain all the necessary items listed in the Note to Yes Reviewer No [X]
Who is responsible for supplying the current and valid certificate of Provider calibration for this temperature monitoring device
Date of calibration testing (report or issue date) Note If there is no expiration date the certificate expires 2 years from the date of calibration Whether the instrument passed or failed testing (or instrument in tolerancenot in tolerance)
bull Recommended element Documented uncertainty of +- 1degF [05degC]
If these elements are present the certificate is considered valid If the certificate contains information about the recommended element or the entity that issued the certificate that is helpful but not required
To determine if a certificate of calibration testing was issued by an appropriate entity check to see if the certificate indicates one or more of these items (this is the wording used to help sites evaluate if their calibration is accurate but is not required on the certificate itself to be considered valid)
bull Conforms to ISO 17025 bull Performed by an ILACMRA Signatory body accredited laboratory You can review this list of the ILAC MRA and Signatories (httpilacorgilac-mra-and-signatories)
bull Traceable to the standards maintained by NIST bull Meets specifications and testing requirements for the American Society for Testing and Materials (ASTM) Standard E2877 tolerance Class F (le 05 degC) or better
bull Includes reference to another acceptable accuracy validation method such as comparison to other traceable reference standards or tests at thermometric fixed points
Note CDC recommends that certifications be issued for the entire monitoring unit (detachable probe data logger etc) and not individual certificates for each component
IPI Advisor Manual | February 2017 Page 37
The 2017 MnVFC Site Visit Paperwork Chapter 4
For 45 E the provider is always responsible for supplying the current and valid certificate of calibration for a temperature monitoring device
bull Tip If the temperature monitoring device has a sticker on the back with the calibration date the site can usually call the company who calibrated the device and get a copy of the certificate if they donrsquot have one
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 46 4 Storage amp Handling Per Unit Probe Placement
Question 46 Is the probe properly placed in this section of the storage unit
Note to Reviewer ldquoProperlyrdquo means that the probe in a commercial or household unit is placed in a central area of the unitdirectly with the vaccines Probes should not be placed in the doors near or against the walls close to vents or on the floor of the unit The only allowable exemption related to this requirement is for providerswho have pharmaceutical storage units (built for vaccine storage) that have either (1) a built-intemperature monitoring device OR (2) a dedicated port for the probe that dictates the placement of theprobe
Answers (Choose one)
Yes No [X]
Review CDC Requirement
The probe must be placed in a central area of the section of the storage unit directly with the vaccines in order to properly measurevaccine temperature The probe should not be placed in the door near or against the walls close to vents or on the floor of theunit For pharmaceutical units with a built-in temperature monitoring device or a dedicated port for a probe that is not in thecenter of the section of the storage unit consult your Immunization Program for guidance on placement
Goal of this question Make sure the temperature monitoring device is in the best location to accurately measure the temperature of the vaccines stored in the unit
Helpful information bull The probe of the temperature monitoring device should be placed directly with the vaccines in the middle of the unit The ONLY allowable exception is for pharmaceutical storage units that have either a built-in thermometer or a dedicated port for the probe that indicates placement of the probe
bull Temperatures can vary within the unit especially household units bull Call MDH at 651-201-5522 if you have questions
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Guide (wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml)
Page 38 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 474 Storage amp Handling Per Unit Temperature Documentation
Question 47 Review the temperature documentation over the past three months for this section of the storage unit todetermine whether the provider has a process in place for properly documenting temperatures twice aday Answer the questions below
A Are there two temperature readings recorded for this section of the storage unit per day
Yes No [X]
B Is there a time date and name (or initials) recorded for each reading Yes No [X]
C What is the current temperature and minmax temperatures (if available) inthis section of the storage unit Use the reviewerrsquos thermometer if the providerrsquos temperature monitoringdevice does not have a current valid certificate of calibration testing or the probe is not properly placed in this section of the storage unit
Current Temperature Minimum Temperature Maximum Temperature Fahrenheit Celsius
D Based on your review of the providerrsquos recent temperature documentationincluding the current temperature is this section of the storage unitmaintaining appropriate temperatures
Yes No [X] Not enough information [X]
Review CDC Requirement
Vaccines must be stored under appropriate temperatures as described in the package inserts at all times Acceptable temperature ranges vary by vaccine type and the range is 36deg F and 46deg F (2deg C and 8deg C) and for frozen vaccines the range is -58deg F and +5deg F (shy50deg C and -15deg C) Exposure to temperatures outside of those included in the package inserts could affect vaccine viability andultimately could leave children unprotected against vaccine-preventable diseases In order to maintain awareness of storage unittemperatures and ensure that vaccines are being stored at appropriate temperatures at all times VFC providers are required to monitor and document temperatures for all vaccine storage units at least twice a day Temperature documentation must contain (1) at least two temperature readings per day (2) the time and date of each reading and (3) the name (or initials) of the personwho assessed and recorded the readings CDC also recommends that VFC providers record the minimum and maximumtemperatures of each unit once each workday (preferably in the morning)
Goal of this question Ensure the temperature is being monitored twice daily is within the required range and documented correctly Use your thermometer to check the temperature if the sitersquos temperature monitoring devicersquos probe is not properly placed or there is not a current certificate of calibration Place your thermometer in the unit at the beginning of the visit to allow sufficient time to reach an accurate temperature The purpose of using your thermometer is to ensure the vaccine is being stored at the proper temperature not to ldquovalidaterdquo their reading
Question 47 D is an assessment question based on information you have learned during your visit You might answer ldquonot enough informationrdquo if the unit is new and they donrsquot have at least three months of data or if the unit is only used as overflow and they are inconsistent with temperature monitoring Mark ldquoNordquo if you have reason to believe the storage unit is not maintaining temperatures properly
Helpful information bull All sites must document temperatures twice a day every day the site is open even if they have a data logger or continuous monitoring system
bull Sites can document the information electronically with some continuous monitoring systems as long as it can show what the current temp is the date time and initials of the person checking ndash this needs to be someone at the site ndash not checking remotely or centrally for a large site or system The site must be able to produce these records during their site visit Reviewing these files can be a challenge due to large volumes and lots of paper
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Temperature Logs on Managing Vaccine (wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml)
IPI Advisor Manual | February 2017 Page 39
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 484 Storage amp Handling Per Unit Temperature Excursions
Question 48 In the event that a temperature excursion(s) occurred in this unit within the last three months requestand review documentation of actions taken to determine whether the provider has a process for properlyaddressing excursions Answer the questions below
A Were vaccines in this unit exposed to out-of-range temperatures in the lastthree months (including today)
Yes No (If no skip to question 49)
B Did the provider quarantine and label vaccines as ldquoDo not userdquo Yes No [X]
C Did the provider place vaccine in a unit where it can be stored under properconditions if applicable
Yes No [X]
D Did the provider contact the Immunization Program to report theexcursion
Yes No [X]
E Was the manufacturer contacted for documentation supporting theusability of the vaccine
Yes No [X]
Review CDC Requirement
The provider must document all excursions and actions taken including the following (1) Quarantine and label vaccines as ldquoDO NOTUSErdquo (2) Place vaccines in a unit where they can be stored under proper conditions (3) Contact the Immunization Program to report an excursion and (4) Contact the vaccine manufacturer to obtain documentation supporting the usability of the vaccine
Goal of this question Address any out-of-range temperatures (temperature excursions) identified in reviewing the last three months of temperature logs or during the site visit If there were any out-of-range temperatures did the site respond appropriately to the situation This is a great opportunity to discuss what to do in the event of an excursion The Clinicians Storage and Handling Mishap Checklist is in the IPI Site Visit information folder and is a good review of the process
Helpful information bull Sites need to know that an excursion does not automatically mean that exposed vaccines are non-viable or unusable Exposed vaccines must be quarantined (marked ldquoDo Not Userdquo) and stored under proper conditions until they have received information from vaccine manufacturers regarding the viability of the vaccine
bull Sites must inform MDH when an excursion occurs
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Clinicians Storage and Handling Mishap Checklist (wwwhealthstatemnusdivsidepcimmunize ipivaxchklstpdf)
Page 40 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 49
Goal of this question Ensure proper placement of vaccines in the storage unit
Note These are all recommendations (best practices) not requirements
Helpful information bull Store vaccine in the middle of the compartment two to three inches away from the coils walls floor and cold air vent The temperature near the floor and walls of the unit differs from that in the middle of the compartment and the cold air vent can freeze refrigerated vaccines
4 Storage amp Handling Per Unit Vaccine Placement
Question 49 Look inside the unit to answer the questions below
A Are vaccines placed in the middle of the unit with space between vaccinesand the sideback of the unit to allow cold air to circulate
Yes No [O]
B Are vaccines stored in their original packages Yes No [O]
C Are there water bottles (for refrigerators) or frozen water bottles (forfreezers) in the unit
Yes No [O]
D Are vaccines store in the doors vegetable bins under or near cooling ventsor on the floor of the unit
Yes [O] No
E Is food being stored in the unit Yes [O] No
Review CDC Recommendation
Vaccines should be stored in their original manufacturer (or CDC centralized distributor) packaging They should be placed in the middle of the unit with space between the vaccines and the sideback of the unit to allow cold air to circulate Vaccines SHOULD NOT be stored in the doors vegetable bins or floor of the unit or under or near cooling vents and there should not be any food inthe unit Water bottles (for refrigerators) or frozen water bottles (for freezers) should be placed throughout each storage unit inorder to (1) stabilize or extend temperatures during a power outage and (2) to serve as physical blocks preventing the placementof vaccines in areas of the unit that are at higher risk for temperature excursions (such as in doors vegetable bins floor ornearunder cooling vents)
bull Vaccines should be kept in their original packaging to Protect them from light Help prevent medication errors by making labels easier to read Provide a moisture barrier that serves as insulation in case of an out-of-range temperature power outage door left open or mechanical failure Simplify managing vaccine inventory
bull Store water bottles in the doors on the floor and near the cold air vent in the refrigerator and frozen water bottles in the freezer to help maintain a stable temperature if there is a power failure and when the door is opened frequently Too many water bottles in the door can prevent the door from closing tightly Mark water bottles ldquoDo Not Drinkrdquo
bull Do not store vaccine in the door or drawers of the refrigerator or freezer Vegetable bins and crisper drawers should be removed from refrigerators or used to store other medical supplies or water bottles
bull If vaccine is stored in a household combination refrigeratorfreezer The top shelf should not be used for storing vaccine because the cold air vent blowing from the freezer will freeze vaccine located there If you must use the top shelf of this type of unit place water bottles underneath the cold air vent to prevent vaccine from being stored there It is recommended that only the refrigerator be used for vaccine storage and a separate stand-alone freezer be used to store frozen vaccine
bull Must not store food or beverages in the refrigerator or freezer because frequent opening of doors can lead to temperature variations that may affect vaccine viability There is also a risk of contaminating vaccines
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Guide (wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml) bull Vaccine Storage Tip Sheet on IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml)
IPI Advisor Manual | February 2017 Page 41
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 4104 Storage amp Handling Per Unit Disconnection from Power Source
Question 410 Ask the provider to demonstrate what measures are taken to ensure that vaccine storage units are notaccidentally physically disconnected from the power supply Which of the following describes the measure(s) taken on this unit
Note to Reviewer bull Large hospitals and healthcare systems may not have the ability to demonstrate labels on plugs or circuitbreakers In such cases verify that the practice has a comprehensive policy and standard operatingprocedures in place to prevent the vaccine storage unit from being physically disconnected from thepower supply
bull While back-up generators may ensure power to the overall facility this question ONLY addresses thevaccine storage unit being accidentally disconnected from the power source either through the plug orthe circuit breaker
Answers A ldquoDo not disconnectrdquo labels on the plug (Choose all that B ldquoWarningrdquo label on the circuit breaker box
apply) C Hard-wired (ie built-in) and has a ldquoDo not disconnectrdquo label on thecircuit breaker box D Hospital or large health care system with a comprehensive written policyand standard operating procedures detailing measures taken to preventvaccine storage units from being accidentally disconnected from the powersupply E No acceptable measures for preventing accidental disconnection frompower supply [X]
[X] The response is non-compliant if only A only B or E is selected
Review CDC Requirement
VFC providers must take steps to protect the power source for all vaccine storage equipment by means of having clear warninglabels on both the plug and the circuit breaker associated with all vaccine storage units Large hospitals and healthcare systems canmeet this requirement by demonstrating that they have comprehensive policies and standard operating procedures to preventvaccine storage units from being physically disconnected from the power supply
Goal of this question Decrease the chance that a vaccine storage unit will be accidently unplugged or power will be turned off while vaccine is in the unit This question addresses only what measures the site has taken to ensure the storage unit is not physically disconnected from its power source
If the site uses labels on the plugs and circuit breakers perform a visual inspection to assess whether the way the stickers are positioned make it clear and obvious to anyone that these units are not to be disconnected
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Do Not Unplug and Warning stickers are included in the folder or available to order on the For
Professionals Order Form (wwwhealthstatemnusdivsidepcimmunizeordermathtml)
Note Once you have completed the 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet for each unit return to the questionnaire to complete sections 5 and 6
Page 42 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
- -
Section 5 Storage amp Handling Site-Wide Question 51
5 Storage amp Handling Site Wide Discussion of Cost amp Quantity of Vaccine
Question 51 Have a discussion with the provider about the cost and quantity of VFC vaccines they are responsible for annually Address the points listed in the note to reviewer below
Note to Reviewer bull Vaccine Shipped (Required) Share the cost of VFC vaccines shipped to the provider in the last calendaryear to make sure the provider understands the contribution made by the VFC Program to their practiceFor new providers who do not have ldquocalendar yearrdquo data share either the actual cost of their currentinventory or use the cost of 10 VFC doses of each of the ACIP-recommended vaccines (approximately $7000) to help estimate their annual cost
bull Storage amp Handling (Required) Make sure the provider understands the cost of vaccines for which they are responsible when they make decisions about purchasing recommended vaccine storage and temperature monitoring equipment
Answer I have discussed with the provider the cost and quantity of vaccines ordered in the previous calendar year
Goal of this question Inform sites of the quantity and value of vaccines that they receive as part of the MnVFC program Providers often donrsquot realize the value of the vaccine in their unit This information is included on your clinic list and on the one page site-specific information
Helpful information bull This discussion must occur and the box on the questionnaire must be checked bull If there isnrsquot actual vaccine value information available tell the site that one vaccine order that includes a box of each of the ACIP recommended vaccines costs approximately $7000
bull MDH may not have specific information for individual sites if they receive vaccine from a central warehouse or pharmacy For those sites MDH will give you numbers for the whole system so you can discuss system wide data as appropriate If individual site information is also included it is usually just varicella-containing vaccines that must be shipped directly to the site
Question 52
5 Storage amp Handling Site Wide Dorm Style Units
Question 52 Determine whether the provider has any dorm-style units on site and answer the questions below
Note to Reviewer A dormitory-style refrigerator is a unit that has both refrigerator and freezer compartments behind a singleexterior door Dorm-style units also have an evaporator plate (cooling coil) which is usually located insidean icemaker compartment (freezer) within the refrigerator
A Does the provider have any dorm-style units that are used at any time tostore vaccines
Yes [X] No (Skip to question 53)
B Does the provider have sufficient space in existing compliant vaccinestorage units to store all vaccines without use of the dorm-style unit at any time
Yes No [X]
Review CDC Requirement
Dorm- and bar-style units are prohibited for vaccine storage Vaccines stored in dorm-style units are considered non-viable and must be returned to the centralized distributor CDC recommends the following vaccine storage unit types (in order of preference)pharmaceutical grade stand-alone or combination units (preferred) householdcommercial stand-alone unitshouseholdcommercial combination units using the refrigerator section only
Goal of this question Ensure no vaccine is stored in dorm-style units even for short periods of time Encourage them to label any units ldquoNo Vaccine Storage Allowedrdquo Vaccine stored in these units is considered non-viable If a site is using a dorm-style unit call the MnVFC program (651-201-5522)
Resource Section 8 in the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 43
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 535 Storage amp Handling Site Wide Storage Unit Space Availability
Question 53 Does the provider have sufficient room across storage units to store current stock as well as anyadditional stock acquired during peak season without overcrowding
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have sufficient storage space to accommodate vaccine stock at the busiest time of year without overcrowding
Goal of this question Ensure that sites have sufficient space in their units to maintain vaccines at the busiest time of year Overcrowding of vaccine limits air circulation and affects the unitrsquos ability to maintain stable temperatures
Helpful information bull Look for signs of overcrowding such as vaccines that are pushed up against the wall bins that are overflowing or storage units that are full during non-peak seasons
Discuss immediate actions if the unit is overcrowded Move some of their vaccines order less vaccine more frequently (once per month preferably) andor purchase another storage unit for overflow
Resource bull Section 8 MnVFC Policy and Procedure Manual
Page 44 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 545 Storage amp Handling Site Wide Expired Vaccines
Question 54 Look in each unit Are there expired vaccines in any of the vaccine storage units at this site
Answers (Choose one)
Yes [X] No
Review CDC Requirement
Vaccines should be rotated weekly and when a new shipment comes in so that longer-dated vaccines are stored behind shorter-dated vaccines If vaccines expire they can no longer be stored in the same storage unit with viable vaccines They must be placedin a container or bag clearly labeled ldquoDo not userdquo and separated from viable vaccines to prevent inadvertent use Expired vaccinemust be returned to the centralized distributor within six months of expiration
Goal of this question Ensure there is no expired vaccine in any storage unit
Helpful information bull Sites can prevent their stock from expiring by rotating vaccines every week andor when a new shipment arrives Longer-dated vaccines are stored towards the back of the unit and shorter-dated vaccines are up front
bull Pay attention to vaccines that expire within the next three months Consider transferring vaccine that will expire soon to another MnVFC-enrolled site that will use the vaccine preferably a site close by It is the transferring sitersquos responsibility to arrange the transfer of the vaccine Be sure to complete the MDH Vaccine Transfer Record form and send it to MDH If they are having difficulty finding a location to accept vaccine contact MDH
bull This is a great opportunity to educate sites about the MDH Nonviable Vaccine Form and the process for returning vaccine The VFC program does get some credit for taxes and fees on vaccine that is returned to the distribution center
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MDH Nonviable Vaccine Form and MDH Vaccine Transfer Record on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfcformshtml)
IPI Advisor Manual | February 2017 Page 45
The 2017 MnVFC Site Visit Paperwork Chapter 4
- -
-
Question 555 Storage amp Handling Site Wide Back up Thermometer
Question 55 Does the provider have a readily available back-up thermometer with a current and valid certificate ofcalibration testing
Note to Reviewer ldquoReadily availablerdquo means that the thermometer is available to perform twice-a-day monitoring for a unit asrequired CDC recommends that the back-up thermometer be maintained on site
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have a readily available back-up thermometer with a current and valid certificate of calibration testing Toprevent the certificates of calibration testing of the primary and back-up thermometers from expiring at the same time the date of calibration testing (or issue date) of the back-up thermometer should be different from the date of calibration testing (or issue date) of the primary thermometer As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meetsVFC program requirements
Goal of this question Ensure sites have one calibrated back-up thermometer onsite that is readily available in the event that the temperature monitoring device in unit fails transportation of vaccine is needed or there are other unexpected circumstances
Helpful information bull As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meets VFC Program requirements
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 56 5 Storage amp Handling Site Wide Preparation of Vaccine
Question 56 When does this provider prepare vaccine for administration to the patient
Note to Reviewer For mass vaccination clinics if one type of vaccine is offered providers may pre-draw up to 10 doses Ifusing pre-filled syringes pre-drawing also means activating the syringe by removing the needle guard orattaching a needle
Answers (Choose all that
apply)
Prepare dose immediately before administration Pre-draw doses for upcoming patients (in a regular clinicpractice) [O] Pre-draw up to 10 doses (in a mass-vaccination clinic) Pre-draw more than 10 doses (in a mass-vaccination clinic) [O] Other [O]
Review CDC Recommendation
CDC recommends preparing vaccines immediately prior to administration in order to assure viability of vaccine and prevent vaccinewastage Vaccines that are not administered immediately are at risk of exposure to temperatures outside of the required rangewhich can affect vaccine viability and ultimately can leave children unprotected against vaccine-preventable diseases
Goal of this question Discuss proper timing and preparation of vaccine(s) for administration These are recommendations not requirements
Helpful information bull Educate staff on the importance of preparing vaccine immediately before administration Pre-drawing of vaccines may lead to concerns related to vaccine viability potency sterility and wastage
Page 46 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 6 Inventory Question 61
6 Inventory Inventory Comparison
Question 61 Visually inspect storage units to determine if existing supply of vaccines proportionately mirrorspopulations served Choose the most accurate statement below
Note to Reviewer bull CDC recommends that providers maintain a four-week supply of inventory bull For this question do not take into account vaccine types that the provider does not order Here simply
make sure that overall the vaccines in the providerrsquos storage units are available in sufficient amounts toserve their patient population
Answers (Choose one)
The current vaccine inventory proportionately reflects the populations identified Only public stock is insufficient [X] Only private stock is insufficient [X] Both public and private stock are insufficient [X] Site uses the replacement method but does not appear to have enough vaccine for their population [X] Other [X]
Review CDC Requirement
VFC providers must order and stock routine vaccines in accordance with their patient population in order to prevent missedvaccination opportunities Having sufficient amounts of all stocks prevents the inadvertent use of VFC vaccines for non-VFC-eligiblepatients and vice versa
Goal of this question Assess whether the site is ordering appropriate quantities of vaccine for the population they serve at their site
Helpful information bull If the site sees 30 percent private-pay patients and 70 percent VFC the stock in their storage units should reflect that proportion If you donrsquot know you can ask the site about their population
bull This is meant to be a general assessment so in a big site if they have only a small amount of vaccine that may indicate an issue with vaccine management
bull CDC recommends smaller more frequent orders (ie monthly) rather than large orders to minimize the amount of vaccine loss if an incident occurs during shipment or in the storage unit Sites should not order more frequently than once a month
bull Sites using the replacement method will only have one stock but it should appear to be large enough for their population
bull Only assess the vaccine types that the site currently stocks in their unit We know there are sites that do not offer all ACIP-recommended vaccines for various reasons That issue will be addressed in question 62
IPI Advisor Manual | February 2017 Page 47
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 626 Inventory ACIP Recommended Vaccines
Question 62 Review providerrsquos current inventory to answer the questions below
A Does the provider offer all routine ACIP-recommendedvaccines for their patient population
Yes (Skip to question C) No [X] Offers all except varicella because direct ship ofvaccine is unavailable from manufacturer
B Which routine vaccines are NOT being offered DTaP Hepatitis A Hepatitis B HIB HPV Influenza Meningococcal
MMR Pneumococcal Polio Rotavirus TdapTd Varicella
C According to Immunization Program Policy does theprovider make accessible all non-routine ACIP-recommended vaccines for those VFC patients whomeet the criteria for receiving them
Yes (Skip to question 63) No [X]
D Which non-routine vaccines are NOT being offered Pneumococcal polysaccharide vaccine (PPSV23) Meningococcal Group B (MenB) Other
Review CDC Requirement
VFC providers agree to comply with immunization schedules dosages and contraindications that are established by the Advisory Committee on Immunization Practices (ACIP) for the vaccines identified and agreed upon in the Provider Agreement UNLESS bull In the VFC providers medical judgment and in accordance with accepted medical practice the VFC provider deems such
compliance to be medically inappropriate for the child bull The particular requirements contradict state law including laws pertaining to religious and other exemptions The VFC program entitles children to the following vaccines DTaP Hepatitis A Hepatitis B HIB HPV Influenza MeningococcalMMR Pneumococcal Polio Rotavirus TdapTd and Varicella VFC providers are also required to ensure that VFC-eligible children have access to non-routine vaccines as needed
Goal of this question Assess if the site is offering all the ACIP-recommended vaccines for the population they serve and these vaccines are in stock on the day of the visit It is important that every MnVFC-eligible child that comes to a providerrsquos office for an immunization is vaccinated
Helpful information bull The Advisory Committee on Immunization Practices (ACIP) is a group of medical and public health experts that develops recommendations on how to use vaccines to control diseases in the United States
bull Specialty providers are not required to offer all routine vaccines but should provide the vaccines appropriate for their population
bull If the site does not offer all routine ACIP-recommended vaccines appropriate for their population check the ldquoNordquo box in Part A then check the appropriate box(es) in Part B for any vaccines not offered Please contact MDH as this situation offers us the opportunity to provide education to the site
bull For non-routine vaccines they must either be in stock or the site must have an alternative protocol in the routine management plan that ensures these children have access when applicable
Resources bull IAC Diseases and Vaccines (wwwimmunizeorgvaccines) bull CDC Advisory Committee on Immunization Practices (ACIP) (wwwcdcgovvaccinesacipindexhtml)
Page 48 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 636 Inventory Separation of Stock
Question 63 Observe how the provider differentiates stock in each storage unit to answer the questions below
A Is it clear which vaccines belong to public stock andwhich belong to private stock
Yes No [X] Not applicable replacement site
B Is it clear which vaccines belong to VFC stock andwhich belong to UUAV stock
Yes No [X] Not applicable replacement site Not applicable not UUAV-enrolled site
Review CDC Requirement
In order to ensure that VFC vaccines are only administered to VFC-eligible children VFC providers that serve both VFC and non-VFCshyeligible children must maintain their vaccine inventories in such a way that they can clearly differentiate public stock from privatestock as well as VFC from other public stock
Goal of this question Assess whether the site can distinguish between MnVFC vaccine and private vaccine If they participate in the Uninsured and Underinsured Adult Vaccine (UUAV) program they should also be able to distinguish between MnVFC stock and UUAV stock Some sites use labels bins boxes etc to differentiate their stock If it is not clear how the site differentiates their stock discuss vaccine management with the staff For follow-up call MDH to discuss doing a follow-up site visit
Sites using the replacement method will not have separate stocksmdashthis is an approved alternative method for keeping track of vaccine
Resource bull Section 10 of the MnVFC Policy and Procedure Manual
IPI Advisor Manual | February 2017 Page 49
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
MnVFC Site Visit Storage and Handling Per Unit Answer Sheet 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet MnVFC PIN ___________________
Question number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
Temperature Monitoring Device Questions Questions 43 47 must be answered separately for the freezer and refrigerator if the unit is a combo Be sure to document responses in the appropriate column
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
All the questions on the Site Visit Storage amp Handling Per Unit Answer Sheet have been discussed previously in section 4 of this manual Use this sheet to record information about all the units at the site visit You will need one sheet for each unit If it is a combination unit (either pharmaceutical or household) you can record both sections on one sheet If they have stand-alone units use one sheet for each unit Do not enter the answers to the questions in section 4 of the questionnaire
If you need more information about any of the questions refer back to the main questionnairemdashthe complete question additional guidance including notes to the reviewer and the CDC requirements are there Also if the site is not meeting the requirement you will go back to the questionnaire to complete the ldquoActions if Non-compliantrdquo section including the root cause analysis and follow-up sections
When you have completed the assessment of all the storage units remember to go back to the questionnaire to complete sections 5 and 6
Page 50 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
ndash
ndash
MnVFC Provider Follow-up PlanThe goal of the Provider Follow-up Plan is to communicate with the site all of the VFC requirements any unmet requirements found during your site visit and the timeline for completing the required action The left hand column is a box to check for ldquoUnmetrdquo requirements
Helpful information bull The form can be used to review what the site is doing well and what they need to work on
bull For requirements that have specific documentation that needs to be sent to you use the notes section
2017 MnVFC Provider Follow-up Plan Site _______________________________________________ MnVFC PIN ____________ Date of Visit ___________
Thank you for participating in this MnVFC compliance site visit Please review this visit summary including follow-up actions and timelines for completion Unmet MnVFC requirements and recommendations have a checked box next to them The goal of this plan is to support you with successfully implementing the program and improving access to vaccines for VFC-eligible children
Unmet Question VFC Requirements Section 1 Changes to Key Staff
Q12 Change in the Medical Director Immunization Manager Vaccine Coordinator or back-upKey Staff must be communicated to the immunization program by emailing healthmnvfcstatemnus Changes Notes
Q12 Key staff must complete the annual training on VFC program requirements and print theAnnual Training certificate of completion Documentation Required Action
Staff that have not completed the MnVFC online training must complete it and send acopy of the certificate to the reviewer Training can be found on the MnVFC website (wwwhealthstatemnusvfc) Due date 1 month
Notes
Unmet Question VFC Requirements Section 2 Eligibility
Q21 Provider staff must possess a working knowledge of all VFC eligibility criteria and use thoseVFC Eligibility criteria to screen children prior to administering VFC vaccines
Categories Notes
bull This form provides documentation needed for follow-up actions when you send your thank you email
The second to last page of the Provider Follow-up Plan has a summary of the MnVFC program recommendations These are to remind the site about best practices they may want to improve upon even though they are not yet requirements of the program For example you could discuss the recommendation about storage units if they currently have a combination household unit and are using both sections
The last section is for your signature and the person you met with In most sites it will be the immunization manager or vaccine coordinator who signs the form unless the medical director attended the site visit You keep the original copy and the site will need to keep a copy for themselves
To be completed by the site visit reviewer
I acknowledge that a VFC site visit was performed on __________________ (visit date) The follow-up plan which includes a list of all current VFC program requirements and recommendations assessed during the visit and any required follow-up actions was provided at the end of the visit
Site visit reviewer
Phone
Reviewer Signature Date
To be completed by the provider
I acknowledge that our practice took part in the VFC site visit noted above I understand the findings of the visit and any required actions that must be taken by our office in order to meet VFC program requirements
Medical Director (or designee) Name Title
Medical Director (or designee) Signature Date
IPI Advisor Manual | February 2017 Page 51
The 2017 MnVFC Site Visit Paperwork Chapter 4
After the Site Visit Send a thank you email highlighting the unmet requirements documents you need from the site to resolve the issue(s) and the date you need them Make sure to include the link to the Site Visit Survey (httpssurveyvovicicomseashxs=56206EE334CE0B14)
Please refer to Chapter 3 for more information about future follow-up required after the visit including forms and documentation
Resource bull Sample Thank You letter on IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml)
Chapter 5
IPI Advisor Resource List MnVFC Program 651-201-5522
MnVFC wwwhealthstatemnusvfc
bull Separate Stock and Replacement Method Policies and Procedures Manuals bull Online trainings bull MnVFC Announcements sign up to receive them via email bull Ordering MDH vaccine bull MnVFC forms Screening forms Reporting forms Others MDH Nonviable Vaccine Form MDH Vaccine Transfer Record and Vaccine Borrowing Report
bull MnVFC promotional materials bull Immunization Billing Guidance for MnVFC and Immunization Billing Guidance for MnVFC Replacement Sites Immunization Practices Improvement Program (IPI) wwwhealthstatemnusdivsidepcimmunizeipi
bull IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml) bull IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml) IPI Resource Folder Contents (wwwhealthstatemnusdivsidepcimmunizeipiipifolderpdf)
Minnesota Immunization Information Connection (MIIC) wwwhealthstatemnusmiic
bull MIIC regions and regional coordinators
Clinical Practice MDH Immunization Program wwwhealthstatemnusimmunize
Got Your Shots News wwwhealthstatemnusdivsidepcnewslettersgys
MDH Immunization Information for Health Care Providers wwwhealthstatemnusdivsidepcimmunizehcp
bull Got Your Shots A Providers Guide to Immunization in Minnesota bull Vaccine protocols bull Forms for tracking patient immunizations bull Immunization schedules for Health Care Providers Immunization Action Coalition (IAC) wwwimmunizeorg
bull Ask the Experts bull VISs (Vaccine Information Statements and translations) bull Administration screening questions bull Medical management of vaccine reactions bull Order form for Californiarsquos Immunization Technique DVD Best Practices with Infants Children and Adults
Page 52 IPI Advisor Manual| February 2017
IPI Advisor Resource List Chapter 5
CDC ldquoPink Bookrdquo wwwcdcgovvaccinespubspinkbookindexhtml
CDC Advisory Committee on Immunization Practices (ACIP) wwwcdcgovvaccinesacip
CDC Vaccines and Immunizations wwwcdcgovvaccines
VAERS reporting httpvaershhsgovindex
Storage and Handling Got Your Shots Providers Guide ndash Managing Vaccine wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml
MnVFC Guide to Temperature Monitoring Devices wwwhealthstatemnusvfc
MDH Clinicianrsquos Vaccine Mishap Checklist wwwhealthstatemnusdivsidepcimmunizeipivaxchklstpdf
MDH Vaccine Storage Guide wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml
CDC Vaccine Storage and Handling Toolkit wwwcdcgovvaccinesrecsstoragetoolkit
You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Vaccine manufacturer phone numbers wwwcdcgovvaccinespubspinkbookdownloadsappendicesFcontact-info-manufactpdf
IAC Checklist for Safe Vaccine Handling and Storage wwwimmunizeorgcatgdp3035pdf
IAC Donrsquot Be Guilty of These Errors in Vaccine Storage and Handling wwwimmunizeorgcatgdp3036pdf
Additional Resources Print materials from MDH ndash order forms wwwhealthstatemnusdivsidepcimmunizeordermathtml
Vaccine Education Center ndash Childrenrsquos Hospital of Philadelphia wwwchopeduservicevaccine-education-centerhomehtml
California Department of Public Health ndash Interactive training on vaccine administration and storage and handling handout on transporting vaccine and how to package wwwezizorg
IPI Advisor Manual | February 2017 Page 53
IPI Advisor Resource List Chapter 5
CDC vaccine price list wwwcdcgovvaccinesprogramsvfcawardeesvaccine-managementprice-listindexhtml
Vaccine Information Statements (VIS) wwwcdcgovvaccineshcpvisindexhtml
CEU Opportunities CDC Immunization Education and Training wwwcdcgovvaccinesedindexhtml
Immunization You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Page 54 IPI Advisor Manual| February 2017
- Introduction
-
- Welcome to the Immunization Practice Improvement (IPI) Program
- Contact Information
-
- Chapter 1
- Requirements to Participate in the MnVFC Program
- Vaccines for Children Program
- Chapter 2
- Reimbursement for MnVFC Visits
- Types of Visits
- Your MnVFC Clinical CoordinatorPlanner
- New IPI Advisor Training Requirements
- Your Role as an IPI Advisor
- Reasons MDH Would Do All or Part of a Visit
- Chapter 3
- Future follow-up
- Conducting the Visit
- Preparing for the Visit
- Information for the Visit
- Site Visit Checklist
- Scheduling the Visit
- Chapter 4
- After the Site Visit
- MnVFC Provider Follow-up Plan
- MnVFC Site Visit Storage and Handling Per Unit Answer Sheet
- Section 6 Inventory
- Section 5 Storage amp Handling Site-Wide
- Section 4 Storage amp Handling Per Unit
- Section 3 Documentation
- Section 2 Eligibility
- Section 1 Provider Details
- The Site Visit Reviewer Legend
- MnVFC Site Visit Questionnaire
- Required Paperwork for Site Visits
- Chapter 5
-
Page 18 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
The Site Visit Reviewer Legend The legend explains the formatting of the 2017 questionnaire This includes information that will be helpful in completing the site visit
Site Visit Reviewer Guide Legend
Section Number Content Area
Question number This area will always contain the text of the question
Note to reviewer The note to reviewer contains information that is necessary for properly asking and assessing responses tothe question above This may include definitions of terms requirement details and other helpful tips
Answers This field will contain all the possible answer choices for this question For most questions answer choiceswill be followed by the markings below
Answer choices marked with an [X] indicate that this specific answer choice is non-compliant with a CDC requirement Answer choices marked with an [O] indicate that this specific answer choice is not aligned with a CDC
recommendation
Review CDC RequirementRecommendation
This field will be populated with the CDC requirementrecommendation associated with the given question
Actions if Non-Compliant
Root Cause Analysis As part of the site visit reviewers are required to assess and understand the reasons why a provider office isnon-compliant with VFC program requirements ndash this is a root cause analysis Reviewers must choose theone root cause that they believe most contributes to the non-compliance Upon establishing the root causethe reviewer must provide a clear explanation of hisher findings
Immediate Action These are actions that CDC requires reviewers to take on site during the visit
Future Follow-up These are future follow-up actions (with designated due dates) that are required of the reviewer andorprovider to remedy non-compliance Reviewers must complete all follow-up in accordance with CDCestablished deadlines
Notes Information you want the VFC program to be aware of or that explains your answer in detail
bull Note to reviewer These are notes to help you understand what the question is asking for and to clarify things you might want to know when asking or rephrasing the question
bull Answers This section helps you to know when the answer does not meet the CDC requirement [X] or recommendation [O] Whenever an answer with a [X] is checked the ldquoActions if Non-compliant section must be completed The recommendations are usually good teaching points about best practices andor future requirements of the VFC program
bull Review the CDC RequirementRecommendation This section provides a specific outline of the requirement or recommendation to give you information to use in talking with the site staff
bull Actions if Non-Compliant This section describes what to do if the site is not meeting a requirement Root cause analysis This section asks you to probe beyond the surface to find what is driving the non-compliance It is intended to help uncover reasons for recurring non-compliance issues identify additional training needs and inform reviewer follow-up actions Select only one root cause and explain the particular circumstances in the space ldquoExplanation of root causerdquo line provided If there appear to be multiple issues choose the one that most contributes to the non-compliance and describe all factors in the explanation Immediate actions A list of actions to take during the site visit to address the issue Future follow-up A list of actions to take after the site visit by the set deadline
bull Notes This section can be used for notes to yourself or to MDH
IPI Advisor Manual | February 2017 Page 19
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 1 Provider Details Questionnaire Coversheet
The first page of the questionnaire collects the demographic information for the site You can use this page to help prepare for the visit Most of the demographic information about the site should be on the site-specific document you received with your clinic list You will validate that this information is current at the time of the site visit It also helps to know if this is a separate stock site or a replacement site before the visit so you can bring a copy of the appropriate MnVFC Policies and Procedure Manual
2017 MnVFC Site Visit Questionnaire Date of visit _____________ Date forms sent to MDH ______________
Site Information
Site name MnVFC PIN
Address Separate Stock Replacement
City ZIP County
Medical Director Email
Immunization Manager Phone
Vaccine Coordinator Phone
Vaccine Coordinator back-up Email
Point of contact Phone
Personnel at site visit
On this page bull The date of the visit and the date when you send these forms to MDH This information helps us track the timeliness of our review and data entry process
bull The vaccine management method used by the site (replacement or separate stock) bull The name and email of the medical director (ideally this is the person who signed the MnVFC
Program Provider Agreement)bull Contact information for the immunization manager vaccine coordinator vaccine coordinator back-up and point-of-contact for this visit The immunization manager vaccine coordinator vaccine coordinator back-up roles are
described in the MnVFC Policies and Procedure Manual The vaccine coordinator back-up may be the immunization manager or another staff person depending on the size of the site and available personnel The Point of Contact is the person you set up the appointment with signs the Provider Follow-
up Plan and receives the follow-up email This may be one of the people listed above
The Post Visit Steps section is a reminder to you about what needs to done after the visit The Education on Immunization Best Practices for Sites section reminds you to provide the resource folder to the site
Page 20 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 12
1 Provider Details Changes to Key Staff
Question 12 Ask the provider about changes to key staff to answer the questions below
A (Choose all that
apply)
At the time of the visit is the Medical Director the same individual that signed the ProviderAgreement and are the Immunization Manager and Vaccine Coordinator the same asthose last reported to the program
Yes No the Medical Director has changed No the Immunization Manager has changed No the Vaccine Coordinator has changed
B (Choose one)
Were all changes communicated to theImmunization Program according to yourprogramrsquos policy
Yes or no staff changes No [X]
C (Choose one)
Based on review of the trainingdocumentation have the current Immunization Manager Vaccine Coordinator and back-up completed all required training
Yes No [X]
Review CDC Requirement
All changes in key staff must be communicated to the Immunization Program in the manner and timeframe defined by theImmunization Program Key staff include the Medical Director or equivalent who signed the Provider Agreement the Immunization Manager Vaccine Coordinator and the back-up VFC providers are required to ensure that all key staff are fully trained on VFC program requirements at all times All training must be documented
Goal of this question Determine if there are new staff in key positions at the site and to make sure staff are properly educated about the MnVFC program A This information can help you determine the level of knowledge and experience the staff have with the MnVFC program Follow-up throughout the visit can be tailored for various levels of staff experience Likewise you may identify additional training needs for new staff
B When sites notify us of changes in key personnel we update their information in MIIC and on the clinic lists We also send the new staff information for completing the online training and direct them to read the appropriate MnVFC Policies and Procedures Manual If the answer to this part is no update the demographic area of the questionnaire and inform the staff that in the future they must notify the MnVFC program (via email or phone) if the immunization manager or vaccine coordinator changes Resource Section 12 of the MnVFC Policies and Procedures Manual
C Annual training must be verified by looking at the certificates for the online training If the answer to this part is no refer the staff to complete the appropriate MnVFC online training found on the MnVFC website (wwwhealthstatemnusvfc) for their program (separate stockreplacement) for the current year and send you a copy of the certificate within 30 days
Resource bull Sections 12 and 14 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 21
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 2 Eligibility Question 21
Goal of this Question Assess whether staff correctly understand which patients are eligible for the MnVFC program Screening ensures that eligible children receive the vaccines that they are entitled to receive under the MnVFC program and helps to prevent fraud or abuse of the program
Children 18 years and younger in these
categories can receive MnVFC vaccine at any enrolled site bull Uninsured bull Enrolled in a Minnesota Health Care Program (MHCP) Medical Assistance (MA) or MinnesotaCare bull American Indian or Alaskan Native
The following categories are considered underinsured and are only MnVFC-eligible at local public health (LPH) Federally Qualified Health Centers (FQHC) Rural Health Centers (RHC) Indian Health Services (IHS) and tribal health clinics
bull Has health insurance that does not cover one or more vaccines as can be the case with newly licensed vaccines that arenrsquot yet covered (MnVFC-eligible for non-covered vaccines only)
bull Has health insurance that caps vaccine coverage at a certain amount Once that amount is reached the child is MnVFC-eligible
Children with insurance that does not cover vaccines until a deductible has been met are considered to be fully insured and are not MnVFC-eligible
Helpful information bull Sites are not required to verify the patientrsquos response to the screening questions For example if a patient states they lost their insurance the site does not need to call the patientrsquos insurance company to confirm
If the site cannot correctly describe the eligibility categories provide educational materialsresources on MnVFC eligibility requirements
Resources bull Patient Eligibility Screening Record on MnVFC Forms (wwwhealthstatemnusdivsidepc immunizemnvfcformshtml)
bull Section 1 of the MnVFC Policies and Procedures Manual
2 Eligibility VFC Eligibility Categories
Question 21 Was the individual responsible for determining patient VFC eligibility able to explain all the factors(including age) that make a child eligible to receive VFC vaccines
A Patient is less than 19 years of age Yes No [X]
B Patient is Medicaid-eligible Yes No [X]
C Patient is uninsured Yes No [X]
D Patient is underinsured Yes No [X]
E Patient is American Indian Yes No [X]
F Patient is Alaska Native Yes No [X]
Review CDC Requirement
VFC providers must possess a working knowledge of all VFC eligibility criteria and use those criteria to screen children prior toadministering VFC vaccines In order to receive VFC vaccine a patient must be under the age of 19 and must be at least one of the following (1) Medicaid-eligible (2) Uninsured (ie child has no health insurance) (3) Underinsured (ie child has health insurancebut coverage does not cover any or certain vaccines ndash underinsured children may only receive VFC vaccines in FQHCRHC ordeputized VFC provider offices and only for vaccines not covered by insurance) and (4) American Indian or Alaska Native (AIAN)
Page 22 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 22
2 Eligibility Billing Practices
Question 22 Is the individualdepartment responsible for billing able to clearly explain how they bill for both the costof vaccine and the vaccine administration fee for each of the eligibility categories below
A Medicaid-eligible Cost of Vaccine Do not bill ndash provided by VFC Admin Fee Bill Medicaid
Yes No [X]
B Uninsured Cost of Vaccine Do not bill ndash provided by VFC Admin Fee If billing can bill patient
Yes No [X]
C Underinsured Cost of Vaccine Do not bill ndash provided by VFC through FQHCsRHCs or deputized providers only all other providers cannotprovide VFC vaccine to underinsured patients Admin Fee If billing can bill patient
Yes No [X]
D American IndianAlaska Native(AIAN)
Cost of Vaccine Do not bill - provided by VFC unless patient is fully insured and parent chooses to use insurance Admin Fee If patient is Medicaid-eligible bill Medicaid if billingand patient is uninsuredunderinsured can bill patient if parentchooses to use private insurance for cost of vaccine billpatientinsurance
Yes No [X]
E Do individuals responsible for billing have access to the results of eligibility screening toensure proper billing
Yes No [X]
Review CDC Requirement
VFC providers must adhere to proper billing practices for vaccine administration fees and clearly understand that VFC vaccine isprovided at no cost to both the VFC provider and eligible children At no time should billing occur for the cost of VFC vaccine Whenadministering VFC vaccine providers should never bill two different ldquopayersrdquo (ie patient Medicaid insurance) for the samevaccine administration fee amount For Medicaid-eligible children Medicaid should be billed for the vaccine administration fee Forall other VFC-eligible populations the patient may be billed within the stateterritory cap established by the Centers for Medicareand Medicaid (CMS) However patients cannot be turned away or reported to collections for inability to pay the administration fee
Goal of this question Determine if the staff correctly understand how to bill patients that are eligible for the MnVFC program Billing appropriately ensures that children can receive low cost immunizations and the site is in compliance with the VFC program
bull If there is any indication that sites could be billing insurance companies or parents for VFC vaccines this should be investigated further
bull Most sites in Minnesota will bill Medicaid with the SL modifier ndash which indicates this is a Medicaid claim
bull The main point is to ensure the site is not billing uninsured children for VFC vaccine and are not charging them more than $2122 per vaccine for the administration fee
bull Non-compliance is usually unintentional and may be resolved with some training In rare cases it could be a glimpse into a larger problem where a site is intentionally billing for financial gain
bull If you think the site is billing inappropriately it is the responsibility of the IPI advisor to report concerns to MDH staff for further assistance
Resources bull Immunization Billing Guidance for MnVFC (wwwhealthstatemnusdivsidepcimmunizemnvfc billingtipshtml) or Immunization Billing Guidance for MnVFC Replacement Method Sites (www healthstatemnusdivsidepcimmunizemnvfcreplacementbillingtipsrephtml)
bull Section 2 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 23
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 232 Eligibility Vaccine Administration Fee
Question 23 Document the actual vaccine administration fee charged to non-Medicaid VFC-eligible patients (confirmwith billing department)
Answers Fee $ [X] Follow-up is required if the provider charges more than the fee cap establishedby the Centers for Medicare and Medicaid (CMS) for your stateterritory ($2122)
Review CDC Requirement
The VFC providerrsquos vaccine administration fee for non-Medicaid VFC-eligible children must not exceed the stateterritory vaccineadministration fee cap established by the Centers for Medicare and Medicaid (CMS) For current fee caps refer to Medicaid Program Payments for Services Furnished by Certain Primary Care Physicians and Charges for Vaccine Administration Under theVaccines for Children Program Final Rule (httpwwwgpogovfdsyspkgFR-2012-11-06pdf2012-26507pdf)
Goal of this question Ensure that sites are not charging more than the federal allowable vaccine administration fee of $2122
bull The Centers for Medicaid and Medicare (CMS) establishes a maximum fee that sites can charge to non-Medicaid-eligible VFC patients in each stateterritory for vaccine administration Health Plans usually negotiate this fee with the site but Medicaid will not pay more
bull If a parent cannot pay the vaccine administration fee the patient cannot be turned away or reported to collections VFC-eligible children must be vaccinated regardless of their ability to pay
bull If the person with whom you are conducting the site visit does not know the exact fee charged to non-Medicaid VFC-eligible patients ask to speak to someone who can verify the exact amount
bull If they are charging more than $2122 for the administration fee ndash please contact MDH staff for help with addressing this situation
Resources bull Immunization Billing Guidance for MnVFC (wwwhealthstatemnusdivsidepcimmunizemnvfc billingtipshtml) or Immunization Billing Guidance for MnVFC Replacement Method Sites (www healthstatemnusdivsidepcimmunizemnvfcreplacementbillingtipsrephtml)
bull Section 2 of the MnVFC Policies and Procedures Manual
Page 24 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 3 Documentation Question 31
3 Documentation Eligibility Screening amp Documentation
Question 31 To answer the questions below the provider must clearly demonstrate the patient intake processReview a minimum of 10 records that contain an immunization visit within the last 6 ndash 12 months
Note to Reviewer Criteria for Record Selection 1) Record selection must be completely random and the provider must not know prior to the visit which
records will be reviewed 2) Patient must have been 0-19 years of age at the last visit (Note Records of 19-year-old patients may
allow you to see if VFC vaccines are being used beyond the allowable age) 3) Must review a mix of public and private-pay patients (if applicable)
A Does the provider have a process that ensures that patients are screened forVFC eligibility at each visit and that screening results are documented at each visit
Yes No [X] (If no skip question F)
B Does the providerrsquos process ensure that staff administering vaccine know which vaccine stock to select from prior to drawing the vaccine
Yes No [X]
C Number of records reviewed If fewer than 10 records are reviewed select the reason why Provider does not have 10 patient records with immunizations in last 12 months
D Do all records contain date of the immunization visit and patientrsquos date of birth Yes No [X]
E Do all records contain the patientrsquos specific eligibility status associated with thedate of the immunization
Yes No [X]
F Do any of the providerrsquos records contain any evidence that the patient received vaccine for which they were not eligible
Yes [X] No
Review CDC Requirement
VFC providers must screen for and document VFC eligibility at each immunization visit Documentation must include the date of the visit and the childrsquos specific eligibility category VFC providers must use screening results to ensure that only VFC-eligible children receive VFC vaccine and that administration fees are billed for as appropriate Eligibility status must be readily available to staff administering vaccine prior to selecting which vaccine stock to use
Goal of this question Ensure the site is screening for eligibility and documenting the eligibility category in the medical record
Review a minimum of 10 records from within the last 6-12 months where the patient received an immunization You must review a mix of public and private pay patients (if applicable)
Random selection is important If the staff have pre-selected records for review do not use and identify additional randomly selected records to review
Helpful information bull Discuss upgrading the electronic health record to make documentation of VFC eligibility screening a required field Documenting eligibility screening in the immunization field promotes better MIIC data
bull Q 31 B Sites using the replacement method of vaccine management only have one stock so you will answer ldquoYesrdquo to this question
Resources bull Patient Eligibility Screening Record on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfcformshtml)
bull Section 1 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 25
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 32
3 Documentation Vaccine Dose Documentation
Question 32 Review a minimum of 10 patient immunization records from the last six months (or 12 months ifnecessary) to assess compliance with documentation requirements set forth by Statute 42 US Code 300aa-25 (See note to reviewer below)
Note to Reviewer Criteria for Record Selection 1) Record selection must be completely random the Provider must not know prior to the visit which records
will be reviewed 2) Patient must have been 0-19 years of age at the last visit (Note Records of 19-year-old patients may allow
you to see if VFC vaccines are being used beyond the allowable age)
Records are Compliant if they Contain ALL the Below Elements
bull Address of clinic where vaccine was administered bull Publication date of VIS bull Name of vaccine administered bull Name of vaccine manufacturer bull Date vaccine was administered bull Lot number bull Date VIS was given bull Name and title of person who administered the
vaccine
A Number of records reviewed
B Number of records that contain ALL required documentation elements
If fewer than 10 records are reviewed select the reason why Provider does not have 10 patient records with immunizations in last 12 months
[X] Follow-up isrequired if one ormore records do not meet requirements
Goal of this question Assess whether the site is documenting all required information in each patientrsquos medical record for every vaccine dose administered in accordance with the National Childhood Vaccine Injury Act
Resources bull Section 6 of the MnVFC Policies and Procedures Manual bull National Vaccine Injury Compensation Program (wwwhrsagovvaccinecompensation)
Question 33
3 Documentation Record Retention
Question 33 Is the provider able to demonstrate (preferred) or clearly describe how they maintain historical VFCeligibility documentation for three years
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers are required to maintain all records related to the VFC program for a minimum of three years (or longer if requiredby state law) and upon request make these records available for review VFC records include but are not limited to VFC screening and eligibility documentation billing records medical records that verify receipt of vaccine vaccine ordering records and vaccinepurchase and accountability records
Goal of this question Make sure the site understands they are required to keep all MnVFC screening documentation for at least three years either electronically or on paper This information should be available to you at the time of the visit and future visits
Resource bull Section 7 of the MnVFC Policies and Procedures Manual
Page 26 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 34
3 Documentation Borrowing Documentation
Question 34 Discuss borrowing practices with the provider to answer the questions below
Note to Reviewer bull To be considered ldquofully documentedrdquo documentation for each borrowed dose must include thefollowing information
Vaccine type borrowed Date the dose was administered Stock used (VFC or private) Reason appropriate vaccine stock was not used Patient name and date of birth Date dose was returned to appropriate stock
A Did the provider state that they had borrowed any vaccines (whetherdocumented or not) since the last VFC Compliance Site Visit
Yes No (If no skip to question 36)
B Are there any doses for which there is no documentation (ie provider hasindicated that doses were borrowed but cannot verify how many or why)
All doses are documented Some doses are not documented [X] No doses are documented [X] (if nodoses documented skip toquestion 36)
C Were all borrowed doses fully documented (See Note to Reviewer above) Yes No [X]
D Were all borrowed VFC doses either replaced or an order submitted to replacethe doses Yes No [X]
Review CDC Requirement
VFC providers are expected to maintain an adequate inventory of vaccine for VFC and non-VFC-eligible patients It is theresponsibility of the VFC provider to appropriately schedule and place vaccine orders VFC providers must also rotate stock to ensure timely use of short-dated vaccines Borrowing of vaccine between private and public inventories must be a rare unplanned occurrence and cannot serve as a replacement system for a VFC providerrsquos privately purchased vaccine inventory All instances ofborrowing must be properly documented reported and replaced
Goal of this question Assess vaccine accountability by verifying that children are receiving vaccine from the appropriate stock
Borrowing is when a fully insured child receives a dose of MnVFC vaccine or a MnVFC-eligible child receives a dose of private vaccine This should be a rare unplanned occurrence The site must document any borrowing of vaccine between stocks ideally on the VFC Borrowing Report Form If they are not currently using the form review it with them and encourage them to post it close to their vaccines It does not need to be sent to MDH but should be kept for 3 years and filed with their MnVFC documents to be reviewed whenever they have a regular or unscheduled (unannounced) site visit
Helpful information bull Understand and report on staffrsquos verbal (ie anecdotal) accounts of borrowing obtained during the visit Often sites do not know that what they do is considered borrowing or they think borrowing is acceptable and documentation isnrsquot needed so long as those vaccines are eventually replaced
bull Since sites using the replacement method only have one stock of vaccine they very rarely borrow bull This question asks for future follow-up in 6 months Make a note on your calendar and ask them to send you a copy of their borrowing reports for the previous 6 months with documentation of doses borrowed and replaced We will remind you if we donrsquot hear from you at the 6 month time frame Complete the Follow-up Form and attach the borrowing form
Resources bull Vaccine Borrowing Report on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfc formshtml)
bull Section 10 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 27
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 353 Documentation Borrowing Reasons
Question 35 Based on your discussion with the provider and a review of borrowing reports document the dosesborrowed for each reason and answer the questions below
Note to Reviewer bull Short-dated vaccines are doses that are likely to expire before they can be used bull Exchanging short-dated vaccines should only occur in practices that have a small number of private
patients
A Reasons for Borrowing a VFC Dose (Enter the number of _____ Private vaccine shipment delay (order placed on time but delay in shippingreceipt)
vaccine doses borrowed for each
reason in the spaces
_____ Private vaccine not useable on arrival (vials broken temperature monitor out of range) _____ Ran out of private vaccine between orders (provider orders not placed on time) [X]
provided) _____ Short-dated private dose was exchanged with VFC stock _____ Accidental use of VFC dose for a private patient (human error) _____ Replacement of private dose with VFC when insurance plan did not cover vaccine _____ OtherDocumented dose did not include reason for borrowing [X]
(Explanation Required) Reasons for Borrowing a Private Dose _____ VFC vaccine shipment delay (order placed on time but delay in shippingreceipt) _____ VFC vaccine not useable on arrival (vials broken temperature monitor out of range) _____ Ran out of VFC stock between orders (provider orders not placed on time) [X] _____ Short-dated VFC vaccine dose was exchanged with private dose _____ Accidental use of a private dose for a VFC-eligible patient (human error) _____ OtherDocumented dose did not include reason for borrowing [X]
(Explanation Required)
B Enter date range for instances of borrowing reviewed in the borrowing report Note If ldquoDate of earliest instancerdquo is not available use the date of the last VFC Compliance Visit If ldquoDate of last instancerdquo is not available use the date of thecurrent VFC Compliance Visit
Date of earliest instance
Date of last instance
C Does borrowing appear to be a routine practice Note To determine whether borrowing is a routine practice assess frequency of and repeating reasons for borrowing Examples Frequent accidental use of incorrect stock exchanging short-dated vaccines or issues with ordering and shipment
Yes [X] No
Goal of this question Determine the reasons why the site is borrowing vaccine
If sites are using the Vaccine Borrowing Report review the reasons for borrowing to help document borrowed VFC andor private doses If they have not been documenting borrowing on this report (or any other form) estimate their borrowing practices If you do not know the date range for their borrowing use the last site visit date to the current visit date The use of ldquootherrdquo as the reported reason for borrowing should be rare if ever and would require explanation and follow up
Helpful information bull Look to see if they routinely maintain insufficient amounts or types of vaccine to support their public and private patients that leads to borrowing
bull Pay attention to borrowing cases documented as ldquoaccidentalrdquo Repetitive accidental borrowing may indicate an issue with ordering processes or insufficient staff training
bull Borrowing is not a place to document wasted or lost doses bull The time period of the borrowing may give you clues about the root cause Were the borrowed doses concentrated in a short period or spread out across several months or a year Are all vaccine types being borrowed or just one
bull If borrowing seems to be an issue discuss vaccine management ordering procedures
Resources bull Vaccine Borrowing Report on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfc formshtml)
bull Section 10 in the MnVFC Policies and Procedures Manual
Page 28 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 36
3 Documentation Vaccine Management Plan
Question 36 Physically review the providerrsquos Vaccine Management Plan to answer the question below
A Does the provider have a Vaccine Management Plan Yes No [X] (If no skip to question 37)
B Does the plan list the current Immunization Manager Vaccine Coordinator andback-up
Yes No [X]
C Does the plan address proper vaccine storage and handling practices Yes No [X]
D Does the plan specify vaccine receiving procedures Yes No [X]
E Does the plan contain procedures for what to do with vaccine in the event of an emergency
Yes No [X]
F Does the plan contain procedures for vaccine ordering Yes No [X]
G Does the plan address inventory control (example stock rotation) Yes No [X]
H Does the plan address how to handle vaccine wastage Yes No [X]
I Does the plan address staff training and documentation on vaccine managementstorage amp handling
Yes No [X]
J Does the plan contain a review date that falls within the last 12 months Yes No [X]
K Has the plan been signed by the individual responsible for its content Yes No [X]
Review CDC Requirement
VFC providers must develop maintain and implement a Vaccine Management Plan for routine and emergency vaccinemanagement The plan must contain the current Vaccine Coordinator and back-up proper storage and handling practicesshipping and receiving procedures emergency procedures procedures for vaccine ordering inventory control (eg stock rotation)how to handle vaccine wastage and staff trainingdocumentation on vaccine management storage and handling The plan must bereviewedupdated annually or more frequently if changes occur A ldquoreview daterdquo and signature are required on all plans in order tovalidate that they are current
Goal of this question Evaluate the sitersquos plan for vaccine management It is especially important that they have a plan for emergency management of their vaccine in the case of equipment failure or power outage Encourage all sites to read and sign the MnVFC Policies and Procedures Manual and complete the emergency plan or be able to show you a plan of their own
If the provider is not able to physically show you the plan at the time of the visit or if the recorded review date is not within the last 12 months you must mark that this requirement is unmet The Vaccine Management Plan is important in times of emergency and it should be easy to access by any staff member at any time Encourage them to post the plan and put a copy with the packing supplies
Helpful information bull Encourage the site to fill in the ldquoImmunization Managerrdquo and ldquoVaccine Coordinatorrdquo fields in the
MnVFC Policies and Procedures Manual for their own referencebull The emergency plan in the manual can be reviewed from last year and included in this yearrsquos manual (with an updated signature and date) if there have not been any changes
bull If information in the plan is outdated site staff will not be well equipped to safely manage vaccines in the event of a power-outage or other emergency situation
bull If their institutional policy is only reviewed and updated every 3-4 years (as many are) the staff may need to sign the MnVFC Polices and Procedure Manual to meet this requirement
Resource Routine Vaccine Management Plan and Emergency Vaccine Management Plan in the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 29
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 37
3 Documentation VIS amp VAERS
Question 37 Review the providerrsquos Vaccine Information Statements (VISs) and discuss providerrsquos VAERS process toanswer the questions below
A Does the provider have readily available up-to-date VISs for all ACIP-recommendedvaccines relevant to the populations it serves
Yes No [X]
B Does the provider make a VIS available for patientsparents before eachvaccination
Yes No [X]
C Does the provider know how and when to report clinically significant adverseevents using VAERS
Yes No [X]
Review CDC Requirement
VFC providers are required to distribute the current Vaccine Information Statements (VIS) each time a vaccine is administered and maintain records in accordance with the National Childhood Vaccine Injury Act (NCVIA) which includes reporting clinicallysignificant adverse events to the Vaccine Adverse Event Reporting System (VAERS) For a list of current VISs visit CDCrsquos Vaccine Information Statements (httpwwwcdcgovvaccineshcpvis) website
Gal of this question Ensure the site has the most current VISs and is giving them to each patientparent before administering the vaccine in compliance with the federal law Parents must be educated about the vaccine their child will receive and be aware of possible contraindications and side-effects in order to make well-informed decisions about their childrsquos health
Helpful information bull Ask to see the sitersquos VISs to determine if they have an active protocol for giving VISs to parents Review to make sure they are current Ask if they know where and how to report vaccine adverse events
Resources bull Section 3 in the MnVFC Policies and Procedures Manual bull CDC Vaccine Information Statements (wwwcdcgovvaccineshcpvisindexhtml) Site may sign up for email updates for the current list of VIS publication dates for the most up-to-date version
bull IAC Itrsquos Federal Law You must give your patients current Vaccine Information Statements (wwwimmunizeorgcatgdp2027pdf)
bull VAERS (httpsvaershhsgovindex)
Question 38
3 Documentation Anaphylaxis protocol
Question 38 Does the site have an anaphylaxis protocol which is clearly posted near the emergency kit
Answers (Choose one)
Yes No [X]
Review CDC Requirement
An anaphylaxis protocol must be clearly posted in the area where vaccines are administered
Goal of this question Make sure site is prepared for a severe allergic or anaphylactic reaction to a vaccine
Resources bull Section 11 in the MnVFC Policies and Procedures Manual bull IAC protocols Child and Teens (wwwimmunizeorgcatgdp3082apdf) and Adults (wwwimmunize orgcatgdp3082pdf)
Page 30 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
i
i i i - li i i i i i l
Section 4 Storage amp Handling Per Unit The goal of this section is to assess vaccine storage
2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet practices in each unit at the site MnVFC PIN ___________________
The 2017 MnVFC Storage amp Handling Per Unit Answer Sheet is a worksheet to document the answers to the questions in this section for each unit (combination or stand-alone) Fill in the answers to the questions in Section 4 on the answer sheet not in the questionnaire
The answer sheet has an abbreviated form of each question If you need further information on that question refer back to the full questionnaire Also if you find an area where the site is not meeting the requirements you will need to go back to that question on the 2017 MnVFC Site Visit Questionnaire to complete ldquoActions if Non- compliantrdquo section including the root cause analysis and follow-up sections If there is a problem in more than one unit make a note on the questionnaire which unit you are referring to in the Notes section
Important You must fully assess any unit that may be used to store VFC vaccines even if there are no VFC vaccines there on the day of the visit If there are no vaccines and the site is not documenting twice a day temperatures discuss the need to ensure the unit is maintaining stable temperatures by monitoring for one week before placing vaccines in the unit
Quest on number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
for the freezer and e co umn
Temperature Monitoring Dev refr gerator f the un
ce Quest ons Quest ons 4 3 4 7 must be answered separate y t s a combo Be sure to document responses n the appropr at
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
44D Data downloaded and reviewed routinely (eg weekly)
Yes No [O]
Yes No [O]
45A Certificate of Calibration Testing Yes No [X]
Yes No [X]
45B Date of calibration
45C Date certificate expires [X] Follow-up is required if expired [X] Follow-up is required if expired
45D Certificate contains all necessary items
Yes No [X]
Yes No [X]
46 Probe properly placed Yes No [X]
Yes No [X]
47A Two temperature readings per day
Yes No [X]
Yes No [X]
47B Time date and name (or initials) for each reading
Yes No [X]
Yes No [X]
47C Current temperature and minmax temperatures (if
Current ________deg Minimum ________deg Maximum _deg
Current ________deg Minimum ________deg Maximum _deg
Sections 5 and 6 contain questions about storage and handling site wide and inventory It is helpful to keep those questions in mind as you assess the individual storage units Think about dorm-style units expired vaccine vaccine supply room for vaccine stocking all the recommended vaccines and separation of stock if appropriate
NOTE The sections that follow require reviewers to validate responses by looking at vaccine storage units temperaturemonitoring equipment and the vaccine inventory inside a unit bull For section 4 use a separate Storage amp Handling Per Unit Answer Sheet for each unit to document the findings (combination
units using both sections can be documented on the same answer sheet) bull When an unmet requirement is identified return to this questionnaire to complete the ldquoActions if Non-compliantrdquo section for
that question bull After you complete one answer sheet for each unit return to the questionnaire to complete sections 5 and 6 using information
you gathered while assessing the units The questions in sections 5 and 6 (Storage amp Handling Site-Wide and Inventory) are notunit-specific but do require that the response be based on a thorough assessment of all the providersrsquo units
4 Storage amp Handling Per Unit
Description On the Storage amp Handling Per Unit Answer Sheet place a name that will allow you or someone else from your program to easily identify this unit in the event of follow-up We recommend using Brand + Location(example Samsung - Room 123) Save each Storage amp Handling Per Unit Answer Sheet with the Brand + Location in the file name
(example SamsungRoom123doc)
IPI Advisor Manual | February 2017 Page 31
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 41
4 Storage amp Handling Per Unit Storage Unit Build amp Use
Question 41 Below select the build and use of the vaccine storage unit you are assessing
Note to Reviewer Dorm-style units Do not add dorm-style units here Dorm-style units will be addressed in section 5 Units storing only private stock You must review these storage units even if they contain only private stockat the time of the visit because that vaccine could be administered to VFC patients
A What type of unit is this A Stand-alone B Combination
B Select use if stand-alone A Freezer B Refrigerator
Select use if combination A Use both sections to store vaccine B Use freezer section only to store vaccine C Use refrigerator section only to store vaccine
Goal of this question Identify the unit you are evaluating The description asks you to create a unique name for this unit so that you will be able to identify the same unit in future site visits Put this description on the top of the answer sheet (ie make and location)
Helpful information bull A stand-alone unit is either a refrigerator or a freezer It does not have both sections in the unit bull If there is a combination unit note if the site uses both the refrigerator and freezer or only one section of the unit to store vaccines CDC does not recommend the use of either section or the freezer section only of combination household units
bull If your site utilizes the separate stock method of vaccine management you must review storage units even if they contain only private stock at the time of the visit because there is a chance that those vaccines could be administered (borrowed) to VFC-eligible patients
Page 32 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 424 Storage amp Handling Per Unit CDC Recommended Storage Units
Question 42 Below document the grade of the vaccine storage unit you are assessing
Note to Reviewer Pharmaceutical Also called ldquopurpose-builtrdquo these units are designed by the manufacturer specifically tostore vaccines or other biological materials Commercial Although usually intended to store food and beverages commercial units are often larger and more powerful than the household units found in most homes Though these units are intended to meet thehigher demands of larger facilities these units are not specifically built for the storage of biologicalmaterials Household (non-commercialdomestic) These units are usually smaller than commercial units and areintended for use in small offices and in homes ndash typically for food storage However just like commercialunits they are not designed specifically for the storage of biological materials Such units are usually available in common home supply stores
Answers (Choose one)
Select grade A Pharmaceutical B CommercialHousehold
[O] CDC does not recommend the use of both sections or the freezer section only of combination commercialhousehold units
Review CDC Recommendation
CDC recommends the following vaccine storage unit types (in order of preference) pharmaceutical grade stand-alone orcombination units (preferred) householdcommercial stand-alone units householdcommercial combination units using therefrigerator section only
Goal of this question Assess the grade and type of each storage unit bull Pharmaceutical grade units may be stand-alone or combination units that are often metal may have glass in the door for viewing inside often have an external digital temperature display and are manufactured by medical companies
bull Commercial or household units often look like your kitchen appliance have vegetablemeat drawers in the unit and are manufactured by household appliance companies
bull Occasionally you might find a medical grade unit which is usually a commercialhousehold unit with a lock and 3-prong plug These are still considered household units because of their ability to maintain proper temperatures and air flow Studies show that household stand-alone units are better able to maintain consistent temperatures than their combination counterparts Combination household units used to store vaccine in both sections of the unit is no longer recommended and may be prohibited in the future Combination household storage units that are having difficulty maintaining a cold enough freezer temperature and a warm enough refrigerator temperature should be replaced or a separate stand-alone freezer should be purchased
For frozen vaccines the most cost effective solution is for the site to purchase a small stand-alone freezer The site may need time to budget for a stand-alone storage unit
Resources bull Replacing Combination Household Units Tip Sheet on IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml)
IPI Advisor Manual | February 2017 Page 33
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 434 Storage amp Handling Per Unit Temperature Monitoring Device in the Unit
Question 43 Determine whether there is a temperature monitoring device in this section of the storage unit andanswer the questions
A Is there a temperature monitoring device in this section of thestorage unit
Yes No [X] (If no skip to question 47)
B Who is responsible for supplying the temperature monitoring device in this section of the storage unit Provider
Review CDC Requirement
Certificates of calibration testing provide confidence that the temperature monitoring device is measuring temperaturesaccurately All units storing VFC vaccines must have a calibrated temperature monitoring device with a current and valid certificateof calibration testing All certificates must contain modeldevice name or number serial number date of calibration testing (report or issue date) and Instrument Passed testingInstrument in Tolerance (Recommended uncertainty = +-05ordm C (+-1ordm F))
Goal of this question Assess whether there is a temperature monitoring device in the unit If the unit is not being monitored at all call MDH at 651-201-5522 for guidance
Helpful information bull This question does not ask whether the temperature monitoring device is working or the characteristics of the device These issues will be addressed later in the questionnaire
bull For part B the provider is always responsible for supplying the temperature monitoring device Even if their thermometer or data logger was originally from MDH it is their responsibility to ensure it is functional and calibrated
Resources bull Section 8 in the MnVFC Policies and Procedures Manual
Page 34 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 444 Storage amp Handling Per Unit CDC Recommended Temperature Monitoring Device
Question 44 Assess the temperature monitoring device in this section of the storage unit to answer the questionsbelow
A Is the temperature monitoring device a continuous monitoring and recordingdevice (eg data logger)
Yes No [O] (Skip D)
B Does the temperature monitoring device have a probe in buffered material Yes No [O]
C Does the temperature monitoring device have a digital display that can beeasily read from the outside of this unit
Yes No [O]
D Is data downloaded and reviewed routinely Yes No [O]
Review CDC Recommendation
As of Jan 1 2018 all VFC providers must use continuous temperature monitoring devices (eg data loggers) to monitor vaccinesthat will be administered to VFC-eligible children Routine review and accessibility of temperature data is critical for determining whether vaccine has been properly stored and for assessing usability of vaccine that was involved in a temperature excursion Tomeet VFC Program requirements the device must also be equipped with bull A temperature probe bull An active temperature display that can be easily read from the outside of the unit bull The capacity for continuous monitoring and recording capabilities where the data can be routinely downloaded
The following are additional recommended features for these devices bull Alarm for out-of-range temperatures bull Current minimum and maximum temperatures display bull Low battery indicator bull Accuracy of +- 1degF (05degC) bull Memory storage of at least 4000 readings bull User programmable logging interval (or reading rate) recommended at a maximum time interval of every 30 minutes bull Use of a probe that best reflects the temperature of the vaccine (such as a buffered probe)
Goal of this question Assess the temperature monitoring device in the storage unit Note that these are all recommendations not requirements at this time
This is a great teaching opportunity for sites who do not currently have a continuous temperature monitoring device Beginning Jan 1 2018 all units that store MnVFC vaccine will be required to have a continuous temperature monitoring device (ie a data logger or a continuous temperature monitoring system) Unlike a minmax thermometer a continuous temperature monitoring device provides detailed information on all temperatures recorded at pre-set intervals For excursions it can provide information on when a temperature went out-of-range for how long and what the temperatures were This is essential information that vaccine manufacturers need to know to assess the viability of the vaccine following an excursion
Helpful information bull Sites are required to monitor and record temperatures twice daily however temperature excursions can easily occur in the 12 hours or longer between readings Continuous temperature monitoring can help manufacturers determine vaccine viability
bull Continue to encourage sites to document and evaluate minimum and maximum temperatures the storage unit reached since the last reading and respond appropriately to out-of-range temperatures
IPI Advisor Manual | February 2017 Page 35
The 2017 MnVFC Site Visit Paperwork Chapter 4
bull It is recommended that sites download and review data weekly Discuss with sites that reviewing temperature monitoring device data also includes responding appropriately if they identify out-of-range temps
bull There is sometimes confusion about the difference between a data logger and a continuous temperature monitoring system Here are some differences
Data Loggers Continuous Monitoring Systems Have an external display similar to thermometers May or may not have an external display Have a detachable probe Probe is usually attached to transmitter Need to be plugged into the computer or cradle to download information on a regular schedule
Wirelessly sends data to computer system
Create a file of data that needs to be saved on the computer
Data is stored within the system not a separate file
Doesnrsquot allow documentation of twice a day temperature checks in the file
May allow documentation of twice a day temperature checks within the system
More about the 2018 requirement for a continuous temperature monitoring device
Required Features bull The continuous temperature monitoring device must have Continuous monitoring and recording capabilities to track and record temperatures over time The capacity to routinely download temperature data to a computer (recommended at least weekly) or wirelessly transmit data Detachable probe in a bottle filled with a thermal buffer (eg bio-safe glycol) if the data logger needs to be detached in order to download data Active temperature display
Recommended Features bull MnVFC recommends continuous temperature monitoring devices with Alarm for out-of-range temperatures Accuracy within +-1degF (+- 05degC) Low battery indicator Display of current minimum and maximum temperatures Memory storage of at least 4000 readings User programmable logging intervals (eg the user can set how often the device records the temperature)
Note that these are all currently recommendations not requirements yet
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Page 36 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 45
Goal of this question Ensure the temperature monitoring device is properly calibrated The certificate of calibration testing means that the device has been tested and it is accurately measuring temperatures within established testing limits The certificate of calibration ensures that the device meets all the required components
Helpful information bull The provider is always responsible for having a current certificate of calibration (or copy) on-site
bull To be considered ldquovalidrdquo a certificate of calibration must contain these required elements Modeldevice name or number Serial number
4 Storage amp Handling Per Unit Certificate of Calibration Testing
Review CDC Requirement
Certificates of calibration testing provide confidence that the temperature monitoring device is measuring temperaturesaccurately All units storing VFC vaccines must have a calibrated temperature monitoring device with a current and valid certificateof calibration testing All certificates must contain modeldevice name or number serial number date of calibration testing (report or issue date) and Instrument Passed testingInstrument in Tolerance (Recommended uncertainty = +-05ordm C (+-1ordm F))
Question 45
Note to Reviewer
A
B
C
D
E
Review the certificate of calibration testing for the temperature monitoring device in this section of the storage unit and answer the questions below
bull How to determine certificate of calibration testing expiration date 1) Identify the certificate issuecalibration date 2) Apply the Immunization Program-required frequency for calibration testing Example If the
issuecalibration date is 12312013 and Immunization Program policy requires testing every twoyears the expiration date is 12312015
bull Certificates must include all of the below bull ModelDevice Name or Number bull Serial Number bull Date of Calibration Testing (Report or Issue Date) bull Instrument Passed testing (Instrument in Tolerance)
Is there a certificate of calibration testing for the temperature monitoring Yes device in this section of the storage unit No [X]
What is the date of calibration for the temperature monitoring device in this section of the storage unit
What is the certificatersquos date of expiration based on ImmunizationProgram policy (See note to reviewer to determine expiration date) [X] Follow-up is required if
certificate is expired
Does the certificate contain all the necessary items listed in the Note to Yes Reviewer No [X]
Who is responsible for supplying the current and valid certificate of Provider calibration for this temperature monitoring device
Date of calibration testing (report or issue date) Note If there is no expiration date the certificate expires 2 years from the date of calibration Whether the instrument passed or failed testing (or instrument in tolerancenot in tolerance)
bull Recommended element Documented uncertainty of +- 1degF [05degC]
If these elements are present the certificate is considered valid If the certificate contains information about the recommended element or the entity that issued the certificate that is helpful but not required
To determine if a certificate of calibration testing was issued by an appropriate entity check to see if the certificate indicates one or more of these items (this is the wording used to help sites evaluate if their calibration is accurate but is not required on the certificate itself to be considered valid)
bull Conforms to ISO 17025 bull Performed by an ILACMRA Signatory body accredited laboratory You can review this list of the ILAC MRA and Signatories (httpilacorgilac-mra-and-signatories)
bull Traceable to the standards maintained by NIST bull Meets specifications and testing requirements for the American Society for Testing and Materials (ASTM) Standard E2877 tolerance Class F (le 05 degC) or better
bull Includes reference to another acceptable accuracy validation method such as comparison to other traceable reference standards or tests at thermometric fixed points
Note CDC recommends that certifications be issued for the entire monitoring unit (detachable probe data logger etc) and not individual certificates for each component
IPI Advisor Manual | February 2017 Page 37
The 2017 MnVFC Site Visit Paperwork Chapter 4
For 45 E the provider is always responsible for supplying the current and valid certificate of calibration for a temperature monitoring device
bull Tip If the temperature monitoring device has a sticker on the back with the calibration date the site can usually call the company who calibrated the device and get a copy of the certificate if they donrsquot have one
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 46 4 Storage amp Handling Per Unit Probe Placement
Question 46 Is the probe properly placed in this section of the storage unit
Note to Reviewer ldquoProperlyrdquo means that the probe in a commercial or household unit is placed in a central area of the unitdirectly with the vaccines Probes should not be placed in the doors near or against the walls close to vents or on the floor of the unit The only allowable exemption related to this requirement is for providerswho have pharmaceutical storage units (built for vaccine storage) that have either (1) a built-intemperature monitoring device OR (2) a dedicated port for the probe that dictates the placement of theprobe
Answers (Choose one)
Yes No [X]
Review CDC Requirement
The probe must be placed in a central area of the section of the storage unit directly with the vaccines in order to properly measurevaccine temperature The probe should not be placed in the door near or against the walls close to vents or on the floor of theunit For pharmaceutical units with a built-in temperature monitoring device or a dedicated port for a probe that is not in thecenter of the section of the storage unit consult your Immunization Program for guidance on placement
Goal of this question Make sure the temperature monitoring device is in the best location to accurately measure the temperature of the vaccines stored in the unit
Helpful information bull The probe of the temperature monitoring device should be placed directly with the vaccines in the middle of the unit The ONLY allowable exception is for pharmaceutical storage units that have either a built-in thermometer or a dedicated port for the probe that indicates placement of the probe
bull Temperatures can vary within the unit especially household units bull Call MDH at 651-201-5522 if you have questions
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Guide (wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml)
Page 38 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 474 Storage amp Handling Per Unit Temperature Documentation
Question 47 Review the temperature documentation over the past three months for this section of the storage unit todetermine whether the provider has a process in place for properly documenting temperatures twice aday Answer the questions below
A Are there two temperature readings recorded for this section of the storage unit per day
Yes No [X]
B Is there a time date and name (or initials) recorded for each reading Yes No [X]
C What is the current temperature and minmax temperatures (if available) inthis section of the storage unit Use the reviewerrsquos thermometer if the providerrsquos temperature monitoringdevice does not have a current valid certificate of calibration testing or the probe is not properly placed in this section of the storage unit
Current Temperature Minimum Temperature Maximum Temperature Fahrenheit Celsius
D Based on your review of the providerrsquos recent temperature documentationincluding the current temperature is this section of the storage unitmaintaining appropriate temperatures
Yes No [X] Not enough information [X]
Review CDC Requirement
Vaccines must be stored under appropriate temperatures as described in the package inserts at all times Acceptable temperature ranges vary by vaccine type and the range is 36deg F and 46deg F (2deg C and 8deg C) and for frozen vaccines the range is -58deg F and +5deg F (shy50deg C and -15deg C) Exposure to temperatures outside of those included in the package inserts could affect vaccine viability andultimately could leave children unprotected against vaccine-preventable diseases In order to maintain awareness of storage unittemperatures and ensure that vaccines are being stored at appropriate temperatures at all times VFC providers are required to monitor and document temperatures for all vaccine storage units at least twice a day Temperature documentation must contain (1) at least two temperature readings per day (2) the time and date of each reading and (3) the name (or initials) of the personwho assessed and recorded the readings CDC also recommends that VFC providers record the minimum and maximumtemperatures of each unit once each workday (preferably in the morning)
Goal of this question Ensure the temperature is being monitored twice daily is within the required range and documented correctly Use your thermometer to check the temperature if the sitersquos temperature monitoring devicersquos probe is not properly placed or there is not a current certificate of calibration Place your thermometer in the unit at the beginning of the visit to allow sufficient time to reach an accurate temperature The purpose of using your thermometer is to ensure the vaccine is being stored at the proper temperature not to ldquovalidaterdquo their reading
Question 47 D is an assessment question based on information you have learned during your visit You might answer ldquonot enough informationrdquo if the unit is new and they donrsquot have at least three months of data or if the unit is only used as overflow and they are inconsistent with temperature monitoring Mark ldquoNordquo if you have reason to believe the storage unit is not maintaining temperatures properly
Helpful information bull All sites must document temperatures twice a day every day the site is open even if they have a data logger or continuous monitoring system
bull Sites can document the information electronically with some continuous monitoring systems as long as it can show what the current temp is the date time and initials of the person checking ndash this needs to be someone at the site ndash not checking remotely or centrally for a large site or system The site must be able to produce these records during their site visit Reviewing these files can be a challenge due to large volumes and lots of paper
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Temperature Logs on Managing Vaccine (wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml)
IPI Advisor Manual | February 2017 Page 39
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 484 Storage amp Handling Per Unit Temperature Excursions
Question 48 In the event that a temperature excursion(s) occurred in this unit within the last three months requestand review documentation of actions taken to determine whether the provider has a process for properlyaddressing excursions Answer the questions below
A Were vaccines in this unit exposed to out-of-range temperatures in the lastthree months (including today)
Yes No (If no skip to question 49)
B Did the provider quarantine and label vaccines as ldquoDo not userdquo Yes No [X]
C Did the provider place vaccine in a unit where it can be stored under properconditions if applicable
Yes No [X]
D Did the provider contact the Immunization Program to report theexcursion
Yes No [X]
E Was the manufacturer contacted for documentation supporting theusability of the vaccine
Yes No [X]
Review CDC Requirement
The provider must document all excursions and actions taken including the following (1) Quarantine and label vaccines as ldquoDO NOTUSErdquo (2) Place vaccines in a unit where they can be stored under proper conditions (3) Contact the Immunization Program to report an excursion and (4) Contact the vaccine manufacturer to obtain documentation supporting the usability of the vaccine
Goal of this question Address any out-of-range temperatures (temperature excursions) identified in reviewing the last three months of temperature logs or during the site visit If there were any out-of-range temperatures did the site respond appropriately to the situation This is a great opportunity to discuss what to do in the event of an excursion The Clinicians Storage and Handling Mishap Checklist is in the IPI Site Visit information folder and is a good review of the process
Helpful information bull Sites need to know that an excursion does not automatically mean that exposed vaccines are non-viable or unusable Exposed vaccines must be quarantined (marked ldquoDo Not Userdquo) and stored under proper conditions until they have received information from vaccine manufacturers regarding the viability of the vaccine
bull Sites must inform MDH when an excursion occurs
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Clinicians Storage and Handling Mishap Checklist (wwwhealthstatemnusdivsidepcimmunize ipivaxchklstpdf)
Page 40 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 49
Goal of this question Ensure proper placement of vaccines in the storage unit
Note These are all recommendations (best practices) not requirements
Helpful information bull Store vaccine in the middle of the compartment two to three inches away from the coils walls floor and cold air vent The temperature near the floor and walls of the unit differs from that in the middle of the compartment and the cold air vent can freeze refrigerated vaccines
4 Storage amp Handling Per Unit Vaccine Placement
Question 49 Look inside the unit to answer the questions below
A Are vaccines placed in the middle of the unit with space between vaccinesand the sideback of the unit to allow cold air to circulate
Yes No [O]
B Are vaccines stored in their original packages Yes No [O]
C Are there water bottles (for refrigerators) or frozen water bottles (forfreezers) in the unit
Yes No [O]
D Are vaccines store in the doors vegetable bins under or near cooling ventsor on the floor of the unit
Yes [O] No
E Is food being stored in the unit Yes [O] No
Review CDC Recommendation
Vaccines should be stored in their original manufacturer (or CDC centralized distributor) packaging They should be placed in the middle of the unit with space between the vaccines and the sideback of the unit to allow cold air to circulate Vaccines SHOULD NOT be stored in the doors vegetable bins or floor of the unit or under or near cooling vents and there should not be any food inthe unit Water bottles (for refrigerators) or frozen water bottles (for freezers) should be placed throughout each storage unit inorder to (1) stabilize or extend temperatures during a power outage and (2) to serve as physical blocks preventing the placementof vaccines in areas of the unit that are at higher risk for temperature excursions (such as in doors vegetable bins floor ornearunder cooling vents)
bull Vaccines should be kept in their original packaging to Protect them from light Help prevent medication errors by making labels easier to read Provide a moisture barrier that serves as insulation in case of an out-of-range temperature power outage door left open or mechanical failure Simplify managing vaccine inventory
bull Store water bottles in the doors on the floor and near the cold air vent in the refrigerator and frozen water bottles in the freezer to help maintain a stable temperature if there is a power failure and when the door is opened frequently Too many water bottles in the door can prevent the door from closing tightly Mark water bottles ldquoDo Not Drinkrdquo
bull Do not store vaccine in the door or drawers of the refrigerator or freezer Vegetable bins and crisper drawers should be removed from refrigerators or used to store other medical supplies or water bottles
bull If vaccine is stored in a household combination refrigeratorfreezer The top shelf should not be used for storing vaccine because the cold air vent blowing from the freezer will freeze vaccine located there If you must use the top shelf of this type of unit place water bottles underneath the cold air vent to prevent vaccine from being stored there It is recommended that only the refrigerator be used for vaccine storage and a separate stand-alone freezer be used to store frozen vaccine
bull Must not store food or beverages in the refrigerator or freezer because frequent opening of doors can lead to temperature variations that may affect vaccine viability There is also a risk of contaminating vaccines
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Guide (wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml) bull Vaccine Storage Tip Sheet on IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml)
IPI Advisor Manual | February 2017 Page 41
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 4104 Storage amp Handling Per Unit Disconnection from Power Source
Question 410 Ask the provider to demonstrate what measures are taken to ensure that vaccine storage units are notaccidentally physically disconnected from the power supply Which of the following describes the measure(s) taken on this unit
Note to Reviewer bull Large hospitals and healthcare systems may not have the ability to demonstrate labels on plugs or circuitbreakers In such cases verify that the practice has a comprehensive policy and standard operatingprocedures in place to prevent the vaccine storage unit from being physically disconnected from thepower supply
bull While back-up generators may ensure power to the overall facility this question ONLY addresses thevaccine storage unit being accidentally disconnected from the power source either through the plug orthe circuit breaker
Answers A ldquoDo not disconnectrdquo labels on the plug (Choose all that B ldquoWarningrdquo label on the circuit breaker box
apply) C Hard-wired (ie built-in) and has a ldquoDo not disconnectrdquo label on thecircuit breaker box D Hospital or large health care system with a comprehensive written policyand standard operating procedures detailing measures taken to preventvaccine storage units from being accidentally disconnected from the powersupply E No acceptable measures for preventing accidental disconnection frompower supply [X]
[X] The response is non-compliant if only A only B or E is selected
Review CDC Requirement
VFC providers must take steps to protect the power source for all vaccine storage equipment by means of having clear warninglabels on both the plug and the circuit breaker associated with all vaccine storage units Large hospitals and healthcare systems canmeet this requirement by demonstrating that they have comprehensive policies and standard operating procedures to preventvaccine storage units from being physically disconnected from the power supply
Goal of this question Decrease the chance that a vaccine storage unit will be accidently unplugged or power will be turned off while vaccine is in the unit This question addresses only what measures the site has taken to ensure the storage unit is not physically disconnected from its power source
If the site uses labels on the plugs and circuit breakers perform a visual inspection to assess whether the way the stickers are positioned make it clear and obvious to anyone that these units are not to be disconnected
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Do Not Unplug and Warning stickers are included in the folder or available to order on the For
Professionals Order Form (wwwhealthstatemnusdivsidepcimmunizeordermathtml)
Note Once you have completed the 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet for each unit return to the questionnaire to complete sections 5 and 6
Page 42 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
- -
Section 5 Storage amp Handling Site-Wide Question 51
5 Storage amp Handling Site Wide Discussion of Cost amp Quantity of Vaccine
Question 51 Have a discussion with the provider about the cost and quantity of VFC vaccines they are responsible for annually Address the points listed in the note to reviewer below
Note to Reviewer bull Vaccine Shipped (Required) Share the cost of VFC vaccines shipped to the provider in the last calendaryear to make sure the provider understands the contribution made by the VFC Program to their practiceFor new providers who do not have ldquocalendar yearrdquo data share either the actual cost of their currentinventory or use the cost of 10 VFC doses of each of the ACIP-recommended vaccines (approximately $7000) to help estimate their annual cost
bull Storage amp Handling (Required) Make sure the provider understands the cost of vaccines for which they are responsible when they make decisions about purchasing recommended vaccine storage and temperature monitoring equipment
Answer I have discussed with the provider the cost and quantity of vaccines ordered in the previous calendar year
Goal of this question Inform sites of the quantity and value of vaccines that they receive as part of the MnVFC program Providers often donrsquot realize the value of the vaccine in their unit This information is included on your clinic list and on the one page site-specific information
Helpful information bull This discussion must occur and the box on the questionnaire must be checked bull If there isnrsquot actual vaccine value information available tell the site that one vaccine order that includes a box of each of the ACIP recommended vaccines costs approximately $7000
bull MDH may not have specific information for individual sites if they receive vaccine from a central warehouse or pharmacy For those sites MDH will give you numbers for the whole system so you can discuss system wide data as appropriate If individual site information is also included it is usually just varicella-containing vaccines that must be shipped directly to the site
Question 52
5 Storage amp Handling Site Wide Dorm Style Units
Question 52 Determine whether the provider has any dorm-style units on site and answer the questions below
Note to Reviewer A dormitory-style refrigerator is a unit that has both refrigerator and freezer compartments behind a singleexterior door Dorm-style units also have an evaporator plate (cooling coil) which is usually located insidean icemaker compartment (freezer) within the refrigerator
A Does the provider have any dorm-style units that are used at any time tostore vaccines
Yes [X] No (Skip to question 53)
B Does the provider have sufficient space in existing compliant vaccinestorage units to store all vaccines without use of the dorm-style unit at any time
Yes No [X]
Review CDC Requirement
Dorm- and bar-style units are prohibited for vaccine storage Vaccines stored in dorm-style units are considered non-viable and must be returned to the centralized distributor CDC recommends the following vaccine storage unit types (in order of preference)pharmaceutical grade stand-alone or combination units (preferred) householdcommercial stand-alone unitshouseholdcommercial combination units using the refrigerator section only
Goal of this question Ensure no vaccine is stored in dorm-style units even for short periods of time Encourage them to label any units ldquoNo Vaccine Storage Allowedrdquo Vaccine stored in these units is considered non-viable If a site is using a dorm-style unit call the MnVFC program (651-201-5522)
Resource Section 8 in the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 43
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 535 Storage amp Handling Site Wide Storage Unit Space Availability
Question 53 Does the provider have sufficient room across storage units to store current stock as well as anyadditional stock acquired during peak season without overcrowding
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have sufficient storage space to accommodate vaccine stock at the busiest time of year without overcrowding
Goal of this question Ensure that sites have sufficient space in their units to maintain vaccines at the busiest time of year Overcrowding of vaccine limits air circulation and affects the unitrsquos ability to maintain stable temperatures
Helpful information bull Look for signs of overcrowding such as vaccines that are pushed up against the wall bins that are overflowing or storage units that are full during non-peak seasons
Discuss immediate actions if the unit is overcrowded Move some of their vaccines order less vaccine more frequently (once per month preferably) andor purchase another storage unit for overflow
Resource bull Section 8 MnVFC Policy and Procedure Manual
Page 44 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 545 Storage amp Handling Site Wide Expired Vaccines
Question 54 Look in each unit Are there expired vaccines in any of the vaccine storage units at this site
Answers (Choose one)
Yes [X] No
Review CDC Requirement
Vaccines should be rotated weekly and when a new shipment comes in so that longer-dated vaccines are stored behind shorter-dated vaccines If vaccines expire they can no longer be stored in the same storage unit with viable vaccines They must be placedin a container or bag clearly labeled ldquoDo not userdquo and separated from viable vaccines to prevent inadvertent use Expired vaccinemust be returned to the centralized distributor within six months of expiration
Goal of this question Ensure there is no expired vaccine in any storage unit
Helpful information bull Sites can prevent their stock from expiring by rotating vaccines every week andor when a new shipment arrives Longer-dated vaccines are stored towards the back of the unit and shorter-dated vaccines are up front
bull Pay attention to vaccines that expire within the next three months Consider transferring vaccine that will expire soon to another MnVFC-enrolled site that will use the vaccine preferably a site close by It is the transferring sitersquos responsibility to arrange the transfer of the vaccine Be sure to complete the MDH Vaccine Transfer Record form and send it to MDH If they are having difficulty finding a location to accept vaccine contact MDH
bull This is a great opportunity to educate sites about the MDH Nonviable Vaccine Form and the process for returning vaccine The VFC program does get some credit for taxes and fees on vaccine that is returned to the distribution center
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MDH Nonviable Vaccine Form and MDH Vaccine Transfer Record on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfcformshtml)
IPI Advisor Manual | February 2017 Page 45
The 2017 MnVFC Site Visit Paperwork Chapter 4
- -
-
Question 555 Storage amp Handling Site Wide Back up Thermometer
Question 55 Does the provider have a readily available back-up thermometer with a current and valid certificate ofcalibration testing
Note to Reviewer ldquoReadily availablerdquo means that the thermometer is available to perform twice-a-day monitoring for a unit asrequired CDC recommends that the back-up thermometer be maintained on site
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have a readily available back-up thermometer with a current and valid certificate of calibration testing Toprevent the certificates of calibration testing of the primary and back-up thermometers from expiring at the same time the date of calibration testing (or issue date) of the back-up thermometer should be different from the date of calibration testing (or issue date) of the primary thermometer As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meetsVFC program requirements
Goal of this question Ensure sites have one calibrated back-up thermometer onsite that is readily available in the event that the temperature monitoring device in unit fails transportation of vaccine is needed or there are other unexpected circumstances
Helpful information bull As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meets VFC Program requirements
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 56 5 Storage amp Handling Site Wide Preparation of Vaccine
Question 56 When does this provider prepare vaccine for administration to the patient
Note to Reviewer For mass vaccination clinics if one type of vaccine is offered providers may pre-draw up to 10 doses Ifusing pre-filled syringes pre-drawing also means activating the syringe by removing the needle guard orattaching a needle
Answers (Choose all that
apply)
Prepare dose immediately before administration Pre-draw doses for upcoming patients (in a regular clinicpractice) [O] Pre-draw up to 10 doses (in a mass-vaccination clinic) Pre-draw more than 10 doses (in a mass-vaccination clinic) [O] Other [O]
Review CDC Recommendation
CDC recommends preparing vaccines immediately prior to administration in order to assure viability of vaccine and prevent vaccinewastage Vaccines that are not administered immediately are at risk of exposure to temperatures outside of the required rangewhich can affect vaccine viability and ultimately can leave children unprotected against vaccine-preventable diseases
Goal of this question Discuss proper timing and preparation of vaccine(s) for administration These are recommendations not requirements
Helpful information bull Educate staff on the importance of preparing vaccine immediately before administration Pre-drawing of vaccines may lead to concerns related to vaccine viability potency sterility and wastage
Page 46 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 6 Inventory Question 61
6 Inventory Inventory Comparison
Question 61 Visually inspect storage units to determine if existing supply of vaccines proportionately mirrorspopulations served Choose the most accurate statement below
Note to Reviewer bull CDC recommends that providers maintain a four-week supply of inventory bull For this question do not take into account vaccine types that the provider does not order Here simply
make sure that overall the vaccines in the providerrsquos storage units are available in sufficient amounts toserve their patient population
Answers (Choose one)
The current vaccine inventory proportionately reflects the populations identified Only public stock is insufficient [X] Only private stock is insufficient [X] Both public and private stock are insufficient [X] Site uses the replacement method but does not appear to have enough vaccine for their population [X] Other [X]
Review CDC Requirement
VFC providers must order and stock routine vaccines in accordance with their patient population in order to prevent missedvaccination opportunities Having sufficient amounts of all stocks prevents the inadvertent use of VFC vaccines for non-VFC-eligiblepatients and vice versa
Goal of this question Assess whether the site is ordering appropriate quantities of vaccine for the population they serve at their site
Helpful information bull If the site sees 30 percent private-pay patients and 70 percent VFC the stock in their storage units should reflect that proportion If you donrsquot know you can ask the site about their population
bull This is meant to be a general assessment so in a big site if they have only a small amount of vaccine that may indicate an issue with vaccine management
bull CDC recommends smaller more frequent orders (ie monthly) rather than large orders to minimize the amount of vaccine loss if an incident occurs during shipment or in the storage unit Sites should not order more frequently than once a month
bull Sites using the replacement method will only have one stock but it should appear to be large enough for their population
bull Only assess the vaccine types that the site currently stocks in their unit We know there are sites that do not offer all ACIP-recommended vaccines for various reasons That issue will be addressed in question 62
IPI Advisor Manual | February 2017 Page 47
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 626 Inventory ACIP Recommended Vaccines
Question 62 Review providerrsquos current inventory to answer the questions below
A Does the provider offer all routine ACIP-recommendedvaccines for their patient population
Yes (Skip to question C) No [X] Offers all except varicella because direct ship ofvaccine is unavailable from manufacturer
B Which routine vaccines are NOT being offered DTaP Hepatitis A Hepatitis B HIB HPV Influenza Meningococcal
MMR Pneumococcal Polio Rotavirus TdapTd Varicella
C According to Immunization Program Policy does theprovider make accessible all non-routine ACIP-recommended vaccines for those VFC patients whomeet the criteria for receiving them
Yes (Skip to question 63) No [X]
D Which non-routine vaccines are NOT being offered Pneumococcal polysaccharide vaccine (PPSV23) Meningococcal Group B (MenB) Other
Review CDC Requirement
VFC providers agree to comply with immunization schedules dosages and contraindications that are established by the Advisory Committee on Immunization Practices (ACIP) for the vaccines identified and agreed upon in the Provider Agreement UNLESS bull In the VFC providers medical judgment and in accordance with accepted medical practice the VFC provider deems such
compliance to be medically inappropriate for the child bull The particular requirements contradict state law including laws pertaining to religious and other exemptions The VFC program entitles children to the following vaccines DTaP Hepatitis A Hepatitis B HIB HPV Influenza MeningococcalMMR Pneumococcal Polio Rotavirus TdapTd and Varicella VFC providers are also required to ensure that VFC-eligible children have access to non-routine vaccines as needed
Goal of this question Assess if the site is offering all the ACIP-recommended vaccines for the population they serve and these vaccines are in stock on the day of the visit It is important that every MnVFC-eligible child that comes to a providerrsquos office for an immunization is vaccinated
Helpful information bull The Advisory Committee on Immunization Practices (ACIP) is a group of medical and public health experts that develops recommendations on how to use vaccines to control diseases in the United States
bull Specialty providers are not required to offer all routine vaccines but should provide the vaccines appropriate for their population
bull If the site does not offer all routine ACIP-recommended vaccines appropriate for their population check the ldquoNordquo box in Part A then check the appropriate box(es) in Part B for any vaccines not offered Please contact MDH as this situation offers us the opportunity to provide education to the site
bull For non-routine vaccines they must either be in stock or the site must have an alternative protocol in the routine management plan that ensures these children have access when applicable
Resources bull IAC Diseases and Vaccines (wwwimmunizeorgvaccines) bull CDC Advisory Committee on Immunization Practices (ACIP) (wwwcdcgovvaccinesacipindexhtml)
Page 48 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 636 Inventory Separation of Stock
Question 63 Observe how the provider differentiates stock in each storage unit to answer the questions below
A Is it clear which vaccines belong to public stock andwhich belong to private stock
Yes No [X] Not applicable replacement site
B Is it clear which vaccines belong to VFC stock andwhich belong to UUAV stock
Yes No [X] Not applicable replacement site Not applicable not UUAV-enrolled site
Review CDC Requirement
In order to ensure that VFC vaccines are only administered to VFC-eligible children VFC providers that serve both VFC and non-VFCshyeligible children must maintain their vaccine inventories in such a way that they can clearly differentiate public stock from privatestock as well as VFC from other public stock
Goal of this question Assess whether the site can distinguish between MnVFC vaccine and private vaccine If they participate in the Uninsured and Underinsured Adult Vaccine (UUAV) program they should also be able to distinguish between MnVFC stock and UUAV stock Some sites use labels bins boxes etc to differentiate their stock If it is not clear how the site differentiates their stock discuss vaccine management with the staff For follow-up call MDH to discuss doing a follow-up site visit
Sites using the replacement method will not have separate stocksmdashthis is an approved alternative method for keeping track of vaccine
Resource bull Section 10 of the MnVFC Policy and Procedure Manual
IPI Advisor Manual | February 2017 Page 49
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
MnVFC Site Visit Storage and Handling Per Unit Answer Sheet 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet MnVFC PIN ___________________
Question number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
Temperature Monitoring Device Questions Questions 43 47 must be answered separately for the freezer and refrigerator if the unit is a combo Be sure to document responses in the appropriate column
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
All the questions on the Site Visit Storage amp Handling Per Unit Answer Sheet have been discussed previously in section 4 of this manual Use this sheet to record information about all the units at the site visit You will need one sheet for each unit If it is a combination unit (either pharmaceutical or household) you can record both sections on one sheet If they have stand-alone units use one sheet for each unit Do not enter the answers to the questions in section 4 of the questionnaire
If you need more information about any of the questions refer back to the main questionnairemdashthe complete question additional guidance including notes to the reviewer and the CDC requirements are there Also if the site is not meeting the requirement you will go back to the questionnaire to complete the ldquoActions if Non-compliantrdquo section including the root cause analysis and follow-up sections
When you have completed the assessment of all the storage units remember to go back to the questionnaire to complete sections 5 and 6
Page 50 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
ndash
ndash
MnVFC Provider Follow-up PlanThe goal of the Provider Follow-up Plan is to communicate with the site all of the VFC requirements any unmet requirements found during your site visit and the timeline for completing the required action The left hand column is a box to check for ldquoUnmetrdquo requirements
Helpful information bull The form can be used to review what the site is doing well and what they need to work on
bull For requirements that have specific documentation that needs to be sent to you use the notes section
2017 MnVFC Provider Follow-up Plan Site _______________________________________________ MnVFC PIN ____________ Date of Visit ___________
Thank you for participating in this MnVFC compliance site visit Please review this visit summary including follow-up actions and timelines for completion Unmet MnVFC requirements and recommendations have a checked box next to them The goal of this plan is to support you with successfully implementing the program and improving access to vaccines for VFC-eligible children
Unmet Question VFC Requirements Section 1 Changes to Key Staff
Q12 Change in the Medical Director Immunization Manager Vaccine Coordinator or back-upKey Staff must be communicated to the immunization program by emailing healthmnvfcstatemnus Changes Notes
Q12 Key staff must complete the annual training on VFC program requirements and print theAnnual Training certificate of completion Documentation Required Action
Staff that have not completed the MnVFC online training must complete it and send acopy of the certificate to the reviewer Training can be found on the MnVFC website (wwwhealthstatemnusvfc) Due date 1 month
Notes
Unmet Question VFC Requirements Section 2 Eligibility
Q21 Provider staff must possess a working knowledge of all VFC eligibility criteria and use thoseVFC Eligibility criteria to screen children prior to administering VFC vaccines
Categories Notes
bull This form provides documentation needed for follow-up actions when you send your thank you email
The second to last page of the Provider Follow-up Plan has a summary of the MnVFC program recommendations These are to remind the site about best practices they may want to improve upon even though they are not yet requirements of the program For example you could discuss the recommendation about storage units if they currently have a combination household unit and are using both sections
The last section is for your signature and the person you met with In most sites it will be the immunization manager or vaccine coordinator who signs the form unless the medical director attended the site visit You keep the original copy and the site will need to keep a copy for themselves
To be completed by the site visit reviewer
I acknowledge that a VFC site visit was performed on __________________ (visit date) The follow-up plan which includes a list of all current VFC program requirements and recommendations assessed during the visit and any required follow-up actions was provided at the end of the visit
Site visit reviewer
Phone
Reviewer Signature Date
To be completed by the provider
I acknowledge that our practice took part in the VFC site visit noted above I understand the findings of the visit and any required actions that must be taken by our office in order to meet VFC program requirements
Medical Director (or designee) Name Title
Medical Director (or designee) Signature Date
IPI Advisor Manual | February 2017 Page 51
The 2017 MnVFC Site Visit Paperwork Chapter 4
After the Site Visit Send a thank you email highlighting the unmet requirements documents you need from the site to resolve the issue(s) and the date you need them Make sure to include the link to the Site Visit Survey (httpssurveyvovicicomseashxs=56206EE334CE0B14)
Please refer to Chapter 3 for more information about future follow-up required after the visit including forms and documentation
Resource bull Sample Thank You letter on IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml)
Chapter 5
IPI Advisor Resource List MnVFC Program 651-201-5522
MnVFC wwwhealthstatemnusvfc
bull Separate Stock and Replacement Method Policies and Procedures Manuals bull Online trainings bull MnVFC Announcements sign up to receive them via email bull Ordering MDH vaccine bull MnVFC forms Screening forms Reporting forms Others MDH Nonviable Vaccine Form MDH Vaccine Transfer Record and Vaccine Borrowing Report
bull MnVFC promotional materials bull Immunization Billing Guidance for MnVFC and Immunization Billing Guidance for MnVFC Replacement Sites Immunization Practices Improvement Program (IPI) wwwhealthstatemnusdivsidepcimmunizeipi
bull IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml) bull IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml) IPI Resource Folder Contents (wwwhealthstatemnusdivsidepcimmunizeipiipifolderpdf)
Minnesota Immunization Information Connection (MIIC) wwwhealthstatemnusmiic
bull MIIC regions and regional coordinators
Clinical Practice MDH Immunization Program wwwhealthstatemnusimmunize
Got Your Shots News wwwhealthstatemnusdivsidepcnewslettersgys
MDH Immunization Information for Health Care Providers wwwhealthstatemnusdivsidepcimmunizehcp
bull Got Your Shots A Providers Guide to Immunization in Minnesota bull Vaccine protocols bull Forms for tracking patient immunizations bull Immunization schedules for Health Care Providers Immunization Action Coalition (IAC) wwwimmunizeorg
bull Ask the Experts bull VISs (Vaccine Information Statements and translations) bull Administration screening questions bull Medical management of vaccine reactions bull Order form for Californiarsquos Immunization Technique DVD Best Practices with Infants Children and Adults
Page 52 IPI Advisor Manual| February 2017
IPI Advisor Resource List Chapter 5
CDC ldquoPink Bookrdquo wwwcdcgovvaccinespubspinkbookindexhtml
CDC Advisory Committee on Immunization Practices (ACIP) wwwcdcgovvaccinesacip
CDC Vaccines and Immunizations wwwcdcgovvaccines
VAERS reporting httpvaershhsgovindex
Storage and Handling Got Your Shots Providers Guide ndash Managing Vaccine wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml
MnVFC Guide to Temperature Monitoring Devices wwwhealthstatemnusvfc
MDH Clinicianrsquos Vaccine Mishap Checklist wwwhealthstatemnusdivsidepcimmunizeipivaxchklstpdf
MDH Vaccine Storage Guide wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml
CDC Vaccine Storage and Handling Toolkit wwwcdcgovvaccinesrecsstoragetoolkit
You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Vaccine manufacturer phone numbers wwwcdcgovvaccinespubspinkbookdownloadsappendicesFcontact-info-manufactpdf
IAC Checklist for Safe Vaccine Handling and Storage wwwimmunizeorgcatgdp3035pdf
IAC Donrsquot Be Guilty of These Errors in Vaccine Storage and Handling wwwimmunizeorgcatgdp3036pdf
Additional Resources Print materials from MDH ndash order forms wwwhealthstatemnusdivsidepcimmunizeordermathtml
Vaccine Education Center ndash Childrenrsquos Hospital of Philadelphia wwwchopeduservicevaccine-education-centerhomehtml
California Department of Public Health ndash Interactive training on vaccine administration and storage and handling handout on transporting vaccine and how to package wwwezizorg
IPI Advisor Manual | February 2017 Page 53
IPI Advisor Resource List Chapter 5
CDC vaccine price list wwwcdcgovvaccinesprogramsvfcawardeesvaccine-managementprice-listindexhtml
Vaccine Information Statements (VIS) wwwcdcgovvaccineshcpvisindexhtml
CEU Opportunities CDC Immunization Education and Training wwwcdcgovvaccinesedindexhtml
Immunization You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Page 54 IPI Advisor Manual| February 2017
- Introduction
-
- Welcome to the Immunization Practice Improvement (IPI) Program
- Contact Information
-
- Chapter 1
- Requirements to Participate in the MnVFC Program
- Vaccines for Children Program
- Chapter 2
- Reimbursement for MnVFC Visits
- Types of Visits
- Your MnVFC Clinical CoordinatorPlanner
- New IPI Advisor Training Requirements
- Your Role as an IPI Advisor
- Reasons MDH Would Do All or Part of a Visit
- Chapter 3
- Future follow-up
- Conducting the Visit
- Preparing for the Visit
- Information for the Visit
- Site Visit Checklist
- Scheduling the Visit
- Chapter 4
- After the Site Visit
- MnVFC Provider Follow-up Plan
- MnVFC Site Visit Storage and Handling Per Unit Answer Sheet
- Section 6 Inventory
- Section 5 Storage amp Handling Site-Wide
- Section 4 Storage amp Handling Per Unit
- Section 3 Documentation
- Section 2 Eligibility
- Section 1 Provider Details
- The Site Visit Reviewer Legend
- MnVFC Site Visit Questionnaire
- Required Paperwork for Site Visits
- Chapter 5
-
IPI Advisor Manual | February 2017 Page 19
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 1 Provider Details Questionnaire Coversheet
The first page of the questionnaire collects the demographic information for the site You can use this page to help prepare for the visit Most of the demographic information about the site should be on the site-specific document you received with your clinic list You will validate that this information is current at the time of the site visit It also helps to know if this is a separate stock site or a replacement site before the visit so you can bring a copy of the appropriate MnVFC Policies and Procedure Manual
2017 MnVFC Site Visit Questionnaire Date of visit _____________ Date forms sent to MDH ______________
Site Information
Site name MnVFC PIN
Address Separate Stock Replacement
City ZIP County
Medical Director Email
Immunization Manager Phone
Vaccine Coordinator Phone
Vaccine Coordinator back-up Email
Point of contact Phone
Personnel at site visit
On this page bull The date of the visit and the date when you send these forms to MDH This information helps us track the timeliness of our review and data entry process
bull The vaccine management method used by the site (replacement or separate stock) bull The name and email of the medical director (ideally this is the person who signed the MnVFC
Program Provider Agreement)bull Contact information for the immunization manager vaccine coordinator vaccine coordinator back-up and point-of-contact for this visit The immunization manager vaccine coordinator vaccine coordinator back-up roles are
described in the MnVFC Policies and Procedure Manual The vaccine coordinator back-up may be the immunization manager or another staff person depending on the size of the site and available personnel The Point of Contact is the person you set up the appointment with signs the Provider Follow-
up Plan and receives the follow-up email This may be one of the people listed above
The Post Visit Steps section is a reminder to you about what needs to done after the visit The Education on Immunization Best Practices for Sites section reminds you to provide the resource folder to the site
Page 20 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 12
1 Provider Details Changes to Key Staff
Question 12 Ask the provider about changes to key staff to answer the questions below
A (Choose all that
apply)
At the time of the visit is the Medical Director the same individual that signed the ProviderAgreement and are the Immunization Manager and Vaccine Coordinator the same asthose last reported to the program
Yes No the Medical Director has changed No the Immunization Manager has changed No the Vaccine Coordinator has changed
B (Choose one)
Were all changes communicated to theImmunization Program according to yourprogramrsquos policy
Yes or no staff changes No [X]
C (Choose one)
Based on review of the trainingdocumentation have the current Immunization Manager Vaccine Coordinator and back-up completed all required training
Yes No [X]
Review CDC Requirement
All changes in key staff must be communicated to the Immunization Program in the manner and timeframe defined by theImmunization Program Key staff include the Medical Director or equivalent who signed the Provider Agreement the Immunization Manager Vaccine Coordinator and the back-up VFC providers are required to ensure that all key staff are fully trained on VFC program requirements at all times All training must be documented
Goal of this question Determine if there are new staff in key positions at the site and to make sure staff are properly educated about the MnVFC program A This information can help you determine the level of knowledge and experience the staff have with the MnVFC program Follow-up throughout the visit can be tailored for various levels of staff experience Likewise you may identify additional training needs for new staff
B When sites notify us of changes in key personnel we update their information in MIIC and on the clinic lists We also send the new staff information for completing the online training and direct them to read the appropriate MnVFC Policies and Procedures Manual If the answer to this part is no update the demographic area of the questionnaire and inform the staff that in the future they must notify the MnVFC program (via email or phone) if the immunization manager or vaccine coordinator changes Resource Section 12 of the MnVFC Policies and Procedures Manual
C Annual training must be verified by looking at the certificates for the online training If the answer to this part is no refer the staff to complete the appropriate MnVFC online training found on the MnVFC website (wwwhealthstatemnusvfc) for their program (separate stockreplacement) for the current year and send you a copy of the certificate within 30 days
Resource bull Sections 12 and 14 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 21
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 2 Eligibility Question 21
Goal of this Question Assess whether staff correctly understand which patients are eligible for the MnVFC program Screening ensures that eligible children receive the vaccines that they are entitled to receive under the MnVFC program and helps to prevent fraud or abuse of the program
Children 18 years and younger in these
categories can receive MnVFC vaccine at any enrolled site bull Uninsured bull Enrolled in a Minnesota Health Care Program (MHCP) Medical Assistance (MA) or MinnesotaCare bull American Indian or Alaskan Native
The following categories are considered underinsured and are only MnVFC-eligible at local public health (LPH) Federally Qualified Health Centers (FQHC) Rural Health Centers (RHC) Indian Health Services (IHS) and tribal health clinics
bull Has health insurance that does not cover one or more vaccines as can be the case with newly licensed vaccines that arenrsquot yet covered (MnVFC-eligible for non-covered vaccines only)
bull Has health insurance that caps vaccine coverage at a certain amount Once that amount is reached the child is MnVFC-eligible
Children with insurance that does not cover vaccines until a deductible has been met are considered to be fully insured and are not MnVFC-eligible
Helpful information bull Sites are not required to verify the patientrsquos response to the screening questions For example if a patient states they lost their insurance the site does not need to call the patientrsquos insurance company to confirm
If the site cannot correctly describe the eligibility categories provide educational materialsresources on MnVFC eligibility requirements
Resources bull Patient Eligibility Screening Record on MnVFC Forms (wwwhealthstatemnusdivsidepc immunizemnvfcformshtml)
bull Section 1 of the MnVFC Policies and Procedures Manual
2 Eligibility VFC Eligibility Categories
Question 21 Was the individual responsible for determining patient VFC eligibility able to explain all the factors(including age) that make a child eligible to receive VFC vaccines
A Patient is less than 19 years of age Yes No [X]
B Patient is Medicaid-eligible Yes No [X]
C Patient is uninsured Yes No [X]
D Patient is underinsured Yes No [X]
E Patient is American Indian Yes No [X]
F Patient is Alaska Native Yes No [X]
Review CDC Requirement
VFC providers must possess a working knowledge of all VFC eligibility criteria and use those criteria to screen children prior toadministering VFC vaccines In order to receive VFC vaccine a patient must be under the age of 19 and must be at least one of the following (1) Medicaid-eligible (2) Uninsured (ie child has no health insurance) (3) Underinsured (ie child has health insurancebut coverage does not cover any or certain vaccines ndash underinsured children may only receive VFC vaccines in FQHCRHC ordeputized VFC provider offices and only for vaccines not covered by insurance) and (4) American Indian or Alaska Native (AIAN)
Page 22 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 22
2 Eligibility Billing Practices
Question 22 Is the individualdepartment responsible for billing able to clearly explain how they bill for both the costof vaccine and the vaccine administration fee for each of the eligibility categories below
A Medicaid-eligible Cost of Vaccine Do not bill ndash provided by VFC Admin Fee Bill Medicaid
Yes No [X]
B Uninsured Cost of Vaccine Do not bill ndash provided by VFC Admin Fee If billing can bill patient
Yes No [X]
C Underinsured Cost of Vaccine Do not bill ndash provided by VFC through FQHCsRHCs or deputized providers only all other providers cannotprovide VFC vaccine to underinsured patients Admin Fee If billing can bill patient
Yes No [X]
D American IndianAlaska Native(AIAN)
Cost of Vaccine Do not bill - provided by VFC unless patient is fully insured and parent chooses to use insurance Admin Fee If patient is Medicaid-eligible bill Medicaid if billingand patient is uninsuredunderinsured can bill patient if parentchooses to use private insurance for cost of vaccine billpatientinsurance
Yes No [X]
E Do individuals responsible for billing have access to the results of eligibility screening toensure proper billing
Yes No [X]
Review CDC Requirement
VFC providers must adhere to proper billing practices for vaccine administration fees and clearly understand that VFC vaccine isprovided at no cost to both the VFC provider and eligible children At no time should billing occur for the cost of VFC vaccine Whenadministering VFC vaccine providers should never bill two different ldquopayersrdquo (ie patient Medicaid insurance) for the samevaccine administration fee amount For Medicaid-eligible children Medicaid should be billed for the vaccine administration fee Forall other VFC-eligible populations the patient may be billed within the stateterritory cap established by the Centers for Medicareand Medicaid (CMS) However patients cannot be turned away or reported to collections for inability to pay the administration fee
Goal of this question Determine if the staff correctly understand how to bill patients that are eligible for the MnVFC program Billing appropriately ensures that children can receive low cost immunizations and the site is in compliance with the VFC program
bull If there is any indication that sites could be billing insurance companies or parents for VFC vaccines this should be investigated further
bull Most sites in Minnesota will bill Medicaid with the SL modifier ndash which indicates this is a Medicaid claim
bull The main point is to ensure the site is not billing uninsured children for VFC vaccine and are not charging them more than $2122 per vaccine for the administration fee
bull Non-compliance is usually unintentional and may be resolved with some training In rare cases it could be a glimpse into a larger problem where a site is intentionally billing for financial gain
bull If you think the site is billing inappropriately it is the responsibility of the IPI advisor to report concerns to MDH staff for further assistance
Resources bull Immunization Billing Guidance for MnVFC (wwwhealthstatemnusdivsidepcimmunizemnvfc billingtipshtml) or Immunization Billing Guidance for MnVFC Replacement Method Sites (www healthstatemnusdivsidepcimmunizemnvfcreplacementbillingtipsrephtml)
bull Section 2 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 23
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 232 Eligibility Vaccine Administration Fee
Question 23 Document the actual vaccine administration fee charged to non-Medicaid VFC-eligible patients (confirmwith billing department)
Answers Fee $ [X] Follow-up is required if the provider charges more than the fee cap establishedby the Centers for Medicare and Medicaid (CMS) for your stateterritory ($2122)
Review CDC Requirement
The VFC providerrsquos vaccine administration fee for non-Medicaid VFC-eligible children must not exceed the stateterritory vaccineadministration fee cap established by the Centers for Medicare and Medicaid (CMS) For current fee caps refer to Medicaid Program Payments for Services Furnished by Certain Primary Care Physicians and Charges for Vaccine Administration Under theVaccines for Children Program Final Rule (httpwwwgpogovfdsyspkgFR-2012-11-06pdf2012-26507pdf)
Goal of this question Ensure that sites are not charging more than the federal allowable vaccine administration fee of $2122
bull The Centers for Medicaid and Medicare (CMS) establishes a maximum fee that sites can charge to non-Medicaid-eligible VFC patients in each stateterritory for vaccine administration Health Plans usually negotiate this fee with the site but Medicaid will not pay more
bull If a parent cannot pay the vaccine administration fee the patient cannot be turned away or reported to collections VFC-eligible children must be vaccinated regardless of their ability to pay
bull If the person with whom you are conducting the site visit does not know the exact fee charged to non-Medicaid VFC-eligible patients ask to speak to someone who can verify the exact amount
bull If they are charging more than $2122 for the administration fee ndash please contact MDH staff for help with addressing this situation
Resources bull Immunization Billing Guidance for MnVFC (wwwhealthstatemnusdivsidepcimmunizemnvfc billingtipshtml) or Immunization Billing Guidance for MnVFC Replacement Method Sites (www healthstatemnusdivsidepcimmunizemnvfcreplacementbillingtipsrephtml)
bull Section 2 of the MnVFC Policies and Procedures Manual
Page 24 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 3 Documentation Question 31
3 Documentation Eligibility Screening amp Documentation
Question 31 To answer the questions below the provider must clearly demonstrate the patient intake processReview a minimum of 10 records that contain an immunization visit within the last 6 ndash 12 months
Note to Reviewer Criteria for Record Selection 1) Record selection must be completely random and the provider must not know prior to the visit which
records will be reviewed 2) Patient must have been 0-19 years of age at the last visit (Note Records of 19-year-old patients may
allow you to see if VFC vaccines are being used beyond the allowable age) 3) Must review a mix of public and private-pay patients (if applicable)
A Does the provider have a process that ensures that patients are screened forVFC eligibility at each visit and that screening results are documented at each visit
Yes No [X] (If no skip question F)
B Does the providerrsquos process ensure that staff administering vaccine know which vaccine stock to select from prior to drawing the vaccine
Yes No [X]
C Number of records reviewed If fewer than 10 records are reviewed select the reason why Provider does not have 10 patient records with immunizations in last 12 months
D Do all records contain date of the immunization visit and patientrsquos date of birth Yes No [X]
E Do all records contain the patientrsquos specific eligibility status associated with thedate of the immunization
Yes No [X]
F Do any of the providerrsquos records contain any evidence that the patient received vaccine for which they were not eligible
Yes [X] No
Review CDC Requirement
VFC providers must screen for and document VFC eligibility at each immunization visit Documentation must include the date of the visit and the childrsquos specific eligibility category VFC providers must use screening results to ensure that only VFC-eligible children receive VFC vaccine and that administration fees are billed for as appropriate Eligibility status must be readily available to staff administering vaccine prior to selecting which vaccine stock to use
Goal of this question Ensure the site is screening for eligibility and documenting the eligibility category in the medical record
Review a minimum of 10 records from within the last 6-12 months where the patient received an immunization You must review a mix of public and private pay patients (if applicable)
Random selection is important If the staff have pre-selected records for review do not use and identify additional randomly selected records to review
Helpful information bull Discuss upgrading the electronic health record to make documentation of VFC eligibility screening a required field Documenting eligibility screening in the immunization field promotes better MIIC data
bull Q 31 B Sites using the replacement method of vaccine management only have one stock so you will answer ldquoYesrdquo to this question
Resources bull Patient Eligibility Screening Record on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfcformshtml)
bull Section 1 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 25
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 32
3 Documentation Vaccine Dose Documentation
Question 32 Review a minimum of 10 patient immunization records from the last six months (or 12 months ifnecessary) to assess compliance with documentation requirements set forth by Statute 42 US Code 300aa-25 (See note to reviewer below)
Note to Reviewer Criteria for Record Selection 1) Record selection must be completely random the Provider must not know prior to the visit which records
will be reviewed 2) Patient must have been 0-19 years of age at the last visit (Note Records of 19-year-old patients may allow
you to see if VFC vaccines are being used beyond the allowable age)
Records are Compliant if they Contain ALL the Below Elements
bull Address of clinic where vaccine was administered bull Publication date of VIS bull Name of vaccine administered bull Name of vaccine manufacturer bull Date vaccine was administered bull Lot number bull Date VIS was given bull Name and title of person who administered the
vaccine
A Number of records reviewed
B Number of records that contain ALL required documentation elements
If fewer than 10 records are reviewed select the reason why Provider does not have 10 patient records with immunizations in last 12 months
[X] Follow-up isrequired if one ormore records do not meet requirements
Goal of this question Assess whether the site is documenting all required information in each patientrsquos medical record for every vaccine dose administered in accordance with the National Childhood Vaccine Injury Act
Resources bull Section 6 of the MnVFC Policies and Procedures Manual bull National Vaccine Injury Compensation Program (wwwhrsagovvaccinecompensation)
Question 33
3 Documentation Record Retention
Question 33 Is the provider able to demonstrate (preferred) or clearly describe how they maintain historical VFCeligibility documentation for three years
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers are required to maintain all records related to the VFC program for a minimum of three years (or longer if requiredby state law) and upon request make these records available for review VFC records include but are not limited to VFC screening and eligibility documentation billing records medical records that verify receipt of vaccine vaccine ordering records and vaccinepurchase and accountability records
Goal of this question Make sure the site understands they are required to keep all MnVFC screening documentation for at least three years either electronically or on paper This information should be available to you at the time of the visit and future visits
Resource bull Section 7 of the MnVFC Policies and Procedures Manual
Page 26 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 34
3 Documentation Borrowing Documentation
Question 34 Discuss borrowing practices with the provider to answer the questions below
Note to Reviewer bull To be considered ldquofully documentedrdquo documentation for each borrowed dose must include thefollowing information
Vaccine type borrowed Date the dose was administered Stock used (VFC or private) Reason appropriate vaccine stock was not used Patient name and date of birth Date dose was returned to appropriate stock
A Did the provider state that they had borrowed any vaccines (whetherdocumented or not) since the last VFC Compliance Site Visit
Yes No (If no skip to question 36)
B Are there any doses for which there is no documentation (ie provider hasindicated that doses were borrowed but cannot verify how many or why)
All doses are documented Some doses are not documented [X] No doses are documented [X] (if nodoses documented skip toquestion 36)
C Were all borrowed doses fully documented (See Note to Reviewer above) Yes No [X]
D Were all borrowed VFC doses either replaced or an order submitted to replacethe doses Yes No [X]
Review CDC Requirement
VFC providers are expected to maintain an adequate inventory of vaccine for VFC and non-VFC-eligible patients It is theresponsibility of the VFC provider to appropriately schedule and place vaccine orders VFC providers must also rotate stock to ensure timely use of short-dated vaccines Borrowing of vaccine between private and public inventories must be a rare unplanned occurrence and cannot serve as a replacement system for a VFC providerrsquos privately purchased vaccine inventory All instances ofborrowing must be properly documented reported and replaced
Goal of this question Assess vaccine accountability by verifying that children are receiving vaccine from the appropriate stock
Borrowing is when a fully insured child receives a dose of MnVFC vaccine or a MnVFC-eligible child receives a dose of private vaccine This should be a rare unplanned occurrence The site must document any borrowing of vaccine between stocks ideally on the VFC Borrowing Report Form If they are not currently using the form review it with them and encourage them to post it close to their vaccines It does not need to be sent to MDH but should be kept for 3 years and filed with their MnVFC documents to be reviewed whenever they have a regular or unscheduled (unannounced) site visit
Helpful information bull Understand and report on staffrsquos verbal (ie anecdotal) accounts of borrowing obtained during the visit Often sites do not know that what they do is considered borrowing or they think borrowing is acceptable and documentation isnrsquot needed so long as those vaccines are eventually replaced
bull Since sites using the replacement method only have one stock of vaccine they very rarely borrow bull This question asks for future follow-up in 6 months Make a note on your calendar and ask them to send you a copy of their borrowing reports for the previous 6 months with documentation of doses borrowed and replaced We will remind you if we donrsquot hear from you at the 6 month time frame Complete the Follow-up Form and attach the borrowing form
Resources bull Vaccine Borrowing Report on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfc formshtml)
bull Section 10 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 27
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 353 Documentation Borrowing Reasons
Question 35 Based on your discussion with the provider and a review of borrowing reports document the dosesborrowed for each reason and answer the questions below
Note to Reviewer bull Short-dated vaccines are doses that are likely to expire before they can be used bull Exchanging short-dated vaccines should only occur in practices that have a small number of private
patients
A Reasons for Borrowing a VFC Dose (Enter the number of _____ Private vaccine shipment delay (order placed on time but delay in shippingreceipt)
vaccine doses borrowed for each
reason in the spaces
_____ Private vaccine not useable on arrival (vials broken temperature monitor out of range) _____ Ran out of private vaccine between orders (provider orders not placed on time) [X]
provided) _____ Short-dated private dose was exchanged with VFC stock _____ Accidental use of VFC dose for a private patient (human error) _____ Replacement of private dose with VFC when insurance plan did not cover vaccine _____ OtherDocumented dose did not include reason for borrowing [X]
(Explanation Required) Reasons for Borrowing a Private Dose _____ VFC vaccine shipment delay (order placed on time but delay in shippingreceipt) _____ VFC vaccine not useable on arrival (vials broken temperature monitor out of range) _____ Ran out of VFC stock between orders (provider orders not placed on time) [X] _____ Short-dated VFC vaccine dose was exchanged with private dose _____ Accidental use of a private dose for a VFC-eligible patient (human error) _____ OtherDocumented dose did not include reason for borrowing [X]
(Explanation Required)
B Enter date range for instances of borrowing reviewed in the borrowing report Note If ldquoDate of earliest instancerdquo is not available use the date of the last VFC Compliance Visit If ldquoDate of last instancerdquo is not available use the date of thecurrent VFC Compliance Visit
Date of earliest instance
Date of last instance
C Does borrowing appear to be a routine practice Note To determine whether borrowing is a routine practice assess frequency of and repeating reasons for borrowing Examples Frequent accidental use of incorrect stock exchanging short-dated vaccines or issues with ordering and shipment
Yes [X] No
Goal of this question Determine the reasons why the site is borrowing vaccine
If sites are using the Vaccine Borrowing Report review the reasons for borrowing to help document borrowed VFC andor private doses If they have not been documenting borrowing on this report (or any other form) estimate their borrowing practices If you do not know the date range for their borrowing use the last site visit date to the current visit date The use of ldquootherrdquo as the reported reason for borrowing should be rare if ever and would require explanation and follow up
Helpful information bull Look to see if they routinely maintain insufficient amounts or types of vaccine to support their public and private patients that leads to borrowing
bull Pay attention to borrowing cases documented as ldquoaccidentalrdquo Repetitive accidental borrowing may indicate an issue with ordering processes or insufficient staff training
bull Borrowing is not a place to document wasted or lost doses bull The time period of the borrowing may give you clues about the root cause Were the borrowed doses concentrated in a short period or spread out across several months or a year Are all vaccine types being borrowed or just one
bull If borrowing seems to be an issue discuss vaccine management ordering procedures
Resources bull Vaccine Borrowing Report on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfc formshtml)
bull Section 10 in the MnVFC Policies and Procedures Manual
Page 28 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 36
3 Documentation Vaccine Management Plan
Question 36 Physically review the providerrsquos Vaccine Management Plan to answer the question below
A Does the provider have a Vaccine Management Plan Yes No [X] (If no skip to question 37)
B Does the plan list the current Immunization Manager Vaccine Coordinator andback-up
Yes No [X]
C Does the plan address proper vaccine storage and handling practices Yes No [X]
D Does the plan specify vaccine receiving procedures Yes No [X]
E Does the plan contain procedures for what to do with vaccine in the event of an emergency
Yes No [X]
F Does the plan contain procedures for vaccine ordering Yes No [X]
G Does the plan address inventory control (example stock rotation) Yes No [X]
H Does the plan address how to handle vaccine wastage Yes No [X]
I Does the plan address staff training and documentation on vaccine managementstorage amp handling
Yes No [X]
J Does the plan contain a review date that falls within the last 12 months Yes No [X]
K Has the plan been signed by the individual responsible for its content Yes No [X]
Review CDC Requirement
VFC providers must develop maintain and implement a Vaccine Management Plan for routine and emergency vaccinemanagement The plan must contain the current Vaccine Coordinator and back-up proper storage and handling practicesshipping and receiving procedures emergency procedures procedures for vaccine ordering inventory control (eg stock rotation)how to handle vaccine wastage and staff trainingdocumentation on vaccine management storage and handling The plan must bereviewedupdated annually or more frequently if changes occur A ldquoreview daterdquo and signature are required on all plans in order tovalidate that they are current
Goal of this question Evaluate the sitersquos plan for vaccine management It is especially important that they have a plan for emergency management of their vaccine in the case of equipment failure or power outage Encourage all sites to read and sign the MnVFC Policies and Procedures Manual and complete the emergency plan or be able to show you a plan of their own
If the provider is not able to physically show you the plan at the time of the visit or if the recorded review date is not within the last 12 months you must mark that this requirement is unmet The Vaccine Management Plan is important in times of emergency and it should be easy to access by any staff member at any time Encourage them to post the plan and put a copy with the packing supplies
Helpful information bull Encourage the site to fill in the ldquoImmunization Managerrdquo and ldquoVaccine Coordinatorrdquo fields in the
MnVFC Policies and Procedures Manual for their own referencebull The emergency plan in the manual can be reviewed from last year and included in this yearrsquos manual (with an updated signature and date) if there have not been any changes
bull If information in the plan is outdated site staff will not be well equipped to safely manage vaccines in the event of a power-outage or other emergency situation
bull If their institutional policy is only reviewed and updated every 3-4 years (as many are) the staff may need to sign the MnVFC Polices and Procedure Manual to meet this requirement
Resource Routine Vaccine Management Plan and Emergency Vaccine Management Plan in the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 29
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 37
3 Documentation VIS amp VAERS
Question 37 Review the providerrsquos Vaccine Information Statements (VISs) and discuss providerrsquos VAERS process toanswer the questions below
A Does the provider have readily available up-to-date VISs for all ACIP-recommendedvaccines relevant to the populations it serves
Yes No [X]
B Does the provider make a VIS available for patientsparents before eachvaccination
Yes No [X]
C Does the provider know how and when to report clinically significant adverseevents using VAERS
Yes No [X]
Review CDC Requirement
VFC providers are required to distribute the current Vaccine Information Statements (VIS) each time a vaccine is administered and maintain records in accordance with the National Childhood Vaccine Injury Act (NCVIA) which includes reporting clinicallysignificant adverse events to the Vaccine Adverse Event Reporting System (VAERS) For a list of current VISs visit CDCrsquos Vaccine Information Statements (httpwwwcdcgovvaccineshcpvis) website
Gal of this question Ensure the site has the most current VISs and is giving them to each patientparent before administering the vaccine in compliance with the federal law Parents must be educated about the vaccine their child will receive and be aware of possible contraindications and side-effects in order to make well-informed decisions about their childrsquos health
Helpful information bull Ask to see the sitersquos VISs to determine if they have an active protocol for giving VISs to parents Review to make sure they are current Ask if they know where and how to report vaccine adverse events
Resources bull Section 3 in the MnVFC Policies and Procedures Manual bull CDC Vaccine Information Statements (wwwcdcgovvaccineshcpvisindexhtml) Site may sign up for email updates for the current list of VIS publication dates for the most up-to-date version
bull IAC Itrsquos Federal Law You must give your patients current Vaccine Information Statements (wwwimmunizeorgcatgdp2027pdf)
bull VAERS (httpsvaershhsgovindex)
Question 38
3 Documentation Anaphylaxis protocol
Question 38 Does the site have an anaphylaxis protocol which is clearly posted near the emergency kit
Answers (Choose one)
Yes No [X]
Review CDC Requirement
An anaphylaxis protocol must be clearly posted in the area where vaccines are administered
Goal of this question Make sure site is prepared for a severe allergic or anaphylactic reaction to a vaccine
Resources bull Section 11 in the MnVFC Policies and Procedures Manual bull IAC protocols Child and Teens (wwwimmunizeorgcatgdp3082apdf) and Adults (wwwimmunize orgcatgdp3082pdf)
Page 30 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
i
i i i - li i i i i i l
Section 4 Storage amp Handling Per Unit The goal of this section is to assess vaccine storage
2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet practices in each unit at the site MnVFC PIN ___________________
The 2017 MnVFC Storage amp Handling Per Unit Answer Sheet is a worksheet to document the answers to the questions in this section for each unit (combination or stand-alone) Fill in the answers to the questions in Section 4 on the answer sheet not in the questionnaire
The answer sheet has an abbreviated form of each question If you need further information on that question refer back to the full questionnaire Also if you find an area where the site is not meeting the requirements you will need to go back to that question on the 2017 MnVFC Site Visit Questionnaire to complete ldquoActions if Non- compliantrdquo section including the root cause analysis and follow-up sections If there is a problem in more than one unit make a note on the questionnaire which unit you are referring to in the Notes section
Important You must fully assess any unit that may be used to store VFC vaccines even if there are no VFC vaccines there on the day of the visit If there are no vaccines and the site is not documenting twice a day temperatures discuss the need to ensure the unit is maintaining stable temperatures by monitoring for one week before placing vaccines in the unit
Quest on number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
for the freezer and e co umn
Temperature Monitoring Dev refr gerator f the un
ce Quest ons Quest ons 4 3 4 7 must be answered separate y t s a combo Be sure to document responses n the appropr at
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
44D Data downloaded and reviewed routinely (eg weekly)
Yes No [O]
Yes No [O]
45A Certificate of Calibration Testing Yes No [X]
Yes No [X]
45B Date of calibration
45C Date certificate expires [X] Follow-up is required if expired [X] Follow-up is required if expired
45D Certificate contains all necessary items
Yes No [X]
Yes No [X]
46 Probe properly placed Yes No [X]
Yes No [X]
47A Two temperature readings per day
Yes No [X]
Yes No [X]
47B Time date and name (or initials) for each reading
Yes No [X]
Yes No [X]
47C Current temperature and minmax temperatures (if
Current ________deg Minimum ________deg Maximum _deg
Current ________deg Minimum ________deg Maximum _deg
Sections 5 and 6 contain questions about storage and handling site wide and inventory It is helpful to keep those questions in mind as you assess the individual storage units Think about dorm-style units expired vaccine vaccine supply room for vaccine stocking all the recommended vaccines and separation of stock if appropriate
NOTE The sections that follow require reviewers to validate responses by looking at vaccine storage units temperaturemonitoring equipment and the vaccine inventory inside a unit bull For section 4 use a separate Storage amp Handling Per Unit Answer Sheet for each unit to document the findings (combination
units using both sections can be documented on the same answer sheet) bull When an unmet requirement is identified return to this questionnaire to complete the ldquoActions if Non-compliantrdquo section for
that question bull After you complete one answer sheet for each unit return to the questionnaire to complete sections 5 and 6 using information
you gathered while assessing the units The questions in sections 5 and 6 (Storage amp Handling Site-Wide and Inventory) are notunit-specific but do require that the response be based on a thorough assessment of all the providersrsquo units
4 Storage amp Handling Per Unit
Description On the Storage amp Handling Per Unit Answer Sheet place a name that will allow you or someone else from your program to easily identify this unit in the event of follow-up We recommend using Brand + Location(example Samsung - Room 123) Save each Storage amp Handling Per Unit Answer Sheet with the Brand + Location in the file name
(example SamsungRoom123doc)
IPI Advisor Manual | February 2017 Page 31
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 41
4 Storage amp Handling Per Unit Storage Unit Build amp Use
Question 41 Below select the build and use of the vaccine storage unit you are assessing
Note to Reviewer Dorm-style units Do not add dorm-style units here Dorm-style units will be addressed in section 5 Units storing only private stock You must review these storage units even if they contain only private stockat the time of the visit because that vaccine could be administered to VFC patients
A What type of unit is this A Stand-alone B Combination
B Select use if stand-alone A Freezer B Refrigerator
Select use if combination A Use both sections to store vaccine B Use freezer section only to store vaccine C Use refrigerator section only to store vaccine
Goal of this question Identify the unit you are evaluating The description asks you to create a unique name for this unit so that you will be able to identify the same unit in future site visits Put this description on the top of the answer sheet (ie make and location)
Helpful information bull A stand-alone unit is either a refrigerator or a freezer It does not have both sections in the unit bull If there is a combination unit note if the site uses both the refrigerator and freezer or only one section of the unit to store vaccines CDC does not recommend the use of either section or the freezer section only of combination household units
bull If your site utilizes the separate stock method of vaccine management you must review storage units even if they contain only private stock at the time of the visit because there is a chance that those vaccines could be administered (borrowed) to VFC-eligible patients
Page 32 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 424 Storage amp Handling Per Unit CDC Recommended Storage Units
Question 42 Below document the grade of the vaccine storage unit you are assessing
Note to Reviewer Pharmaceutical Also called ldquopurpose-builtrdquo these units are designed by the manufacturer specifically tostore vaccines or other biological materials Commercial Although usually intended to store food and beverages commercial units are often larger and more powerful than the household units found in most homes Though these units are intended to meet thehigher demands of larger facilities these units are not specifically built for the storage of biologicalmaterials Household (non-commercialdomestic) These units are usually smaller than commercial units and areintended for use in small offices and in homes ndash typically for food storage However just like commercialunits they are not designed specifically for the storage of biological materials Such units are usually available in common home supply stores
Answers (Choose one)
Select grade A Pharmaceutical B CommercialHousehold
[O] CDC does not recommend the use of both sections or the freezer section only of combination commercialhousehold units
Review CDC Recommendation
CDC recommends the following vaccine storage unit types (in order of preference) pharmaceutical grade stand-alone orcombination units (preferred) householdcommercial stand-alone units householdcommercial combination units using therefrigerator section only
Goal of this question Assess the grade and type of each storage unit bull Pharmaceutical grade units may be stand-alone or combination units that are often metal may have glass in the door for viewing inside often have an external digital temperature display and are manufactured by medical companies
bull Commercial or household units often look like your kitchen appliance have vegetablemeat drawers in the unit and are manufactured by household appliance companies
bull Occasionally you might find a medical grade unit which is usually a commercialhousehold unit with a lock and 3-prong plug These are still considered household units because of their ability to maintain proper temperatures and air flow Studies show that household stand-alone units are better able to maintain consistent temperatures than their combination counterparts Combination household units used to store vaccine in both sections of the unit is no longer recommended and may be prohibited in the future Combination household storage units that are having difficulty maintaining a cold enough freezer temperature and a warm enough refrigerator temperature should be replaced or a separate stand-alone freezer should be purchased
For frozen vaccines the most cost effective solution is for the site to purchase a small stand-alone freezer The site may need time to budget for a stand-alone storage unit
Resources bull Replacing Combination Household Units Tip Sheet on IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml)
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The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 434 Storage amp Handling Per Unit Temperature Monitoring Device in the Unit
Question 43 Determine whether there is a temperature monitoring device in this section of the storage unit andanswer the questions
A Is there a temperature monitoring device in this section of thestorage unit
Yes No [X] (If no skip to question 47)
B Who is responsible for supplying the temperature monitoring device in this section of the storage unit Provider
Review CDC Requirement
Certificates of calibration testing provide confidence that the temperature monitoring device is measuring temperaturesaccurately All units storing VFC vaccines must have a calibrated temperature monitoring device with a current and valid certificateof calibration testing All certificates must contain modeldevice name or number serial number date of calibration testing (report or issue date) and Instrument Passed testingInstrument in Tolerance (Recommended uncertainty = +-05ordm C (+-1ordm F))
Goal of this question Assess whether there is a temperature monitoring device in the unit If the unit is not being monitored at all call MDH at 651-201-5522 for guidance
Helpful information bull This question does not ask whether the temperature monitoring device is working or the characteristics of the device These issues will be addressed later in the questionnaire
bull For part B the provider is always responsible for supplying the temperature monitoring device Even if their thermometer or data logger was originally from MDH it is their responsibility to ensure it is functional and calibrated
Resources bull Section 8 in the MnVFC Policies and Procedures Manual
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-
Question 444 Storage amp Handling Per Unit CDC Recommended Temperature Monitoring Device
Question 44 Assess the temperature monitoring device in this section of the storage unit to answer the questionsbelow
A Is the temperature monitoring device a continuous monitoring and recordingdevice (eg data logger)
Yes No [O] (Skip D)
B Does the temperature monitoring device have a probe in buffered material Yes No [O]
C Does the temperature monitoring device have a digital display that can beeasily read from the outside of this unit
Yes No [O]
D Is data downloaded and reviewed routinely Yes No [O]
Review CDC Recommendation
As of Jan 1 2018 all VFC providers must use continuous temperature monitoring devices (eg data loggers) to monitor vaccinesthat will be administered to VFC-eligible children Routine review and accessibility of temperature data is critical for determining whether vaccine has been properly stored and for assessing usability of vaccine that was involved in a temperature excursion Tomeet VFC Program requirements the device must also be equipped with bull A temperature probe bull An active temperature display that can be easily read from the outside of the unit bull The capacity for continuous monitoring and recording capabilities where the data can be routinely downloaded
The following are additional recommended features for these devices bull Alarm for out-of-range temperatures bull Current minimum and maximum temperatures display bull Low battery indicator bull Accuracy of +- 1degF (05degC) bull Memory storage of at least 4000 readings bull User programmable logging interval (or reading rate) recommended at a maximum time interval of every 30 minutes bull Use of a probe that best reflects the temperature of the vaccine (such as a buffered probe)
Goal of this question Assess the temperature monitoring device in the storage unit Note that these are all recommendations not requirements at this time
This is a great teaching opportunity for sites who do not currently have a continuous temperature monitoring device Beginning Jan 1 2018 all units that store MnVFC vaccine will be required to have a continuous temperature monitoring device (ie a data logger or a continuous temperature monitoring system) Unlike a minmax thermometer a continuous temperature monitoring device provides detailed information on all temperatures recorded at pre-set intervals For excursions it can provide information on when a temperature went out-of-range for how long and what the temperatures were This is essential information that vaccine manufacturers need to know to assess the viability of the vaccine following an excursion
Helpful information bull Sites are required to monitor and record temperatures twice daily however temperature excursions can easily occur in the 12 hours or longer between readings Continuous temperature monitoring can help manufacturers determine vaccine viability
bull Continue to encourage sites to document and evaluate minimum and maximum temperatures the storage unit reached since the last reading and respond appropriately to out-of-range temperatures
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The 2017 MnVFC Site Visit Paperwork Chapter 4
bull It is recommended that sites download and review data weekly Discuss with sites that reviewing temperature monitoring device data also includes responding appropriately if they identify out-of-range temps
bull There is sometimes confusion about the difference between a data logger and a continuous temperature monitoring system Here are some differences
Data Loggers Continuous Monitoring Systems Have an external display similar to thermometers May or may not have an external display Have a detachable probe Probe is usually attached to transmitter Need to be plugged into the computer or cradle to download information on a regular schedule
Wirelessly sends data to computer system
Create a file of data that needs to be saved on the computer
Data is stored within the system not a separate file
Doesnrsquot allow documentation of twice a day temperature checks in the file
May allow documentation of twice a day temperature checks within the system
More about the 2018 requirement for a continuous temperature monitoring device
Required Features bull The continuous temperature monitoring device must have Continuous monitoring and recording capabilities to track and record temperatures over time The capacity to routinely download temperature data to a computer (recommended at least weekly) or wirelessly transmit data Detachable probe in a bottle filled with a thermal buffer (eg bio-safe glycol) if the data logger needs to be detached in order to download data Active temperature display
Recommended Features bull MnVFC recommends continuous temperature monitoring devices with Alarm for out-of-range temperatures Accuracy within +-1degF (+- 05degC) Low battery indicator Display of current minimum and maximum temperatures Memory storage of at least 4000 readings User programmable logging intervals (eg the user can set how often the device records the temperature)
Note that these are all currently recommendations not requirements yet
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
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The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 45
Goal of this question Ensure the temperature monitoring device is properly calibrated The certificate of calibration testing means that the device has been tested and it is accurately measuring temperatures within established testing limits The certificate of calibration ensures that the device meets all the required components
Helpful information bull The provider is always responsible for having a current certificate of calibration (or copy) on-site
bull To be considered ldquovalidrdquo a certificate of calibration must contain these required elements Modeldevice name or number Serial number
4 Storage amp Handling Per Unit Certificate of Calibration Testing
Review CDC Requirement
Certificates of calibration testing provide confidence that the temperature monitoring device is measuring temperaturesaccurately All units storing VFC vaccines must have a calibrated temperature monitoring device with a current and valid certificateof calibration testing All certificates must contain modeldevice name or number serial number date of calibration testing (report or issue date) and Instrument Passed testingInstrument in Tolerance (Recommended uncertainty = +-05ordm C (+-1ordm F))
Question 45
Note to Reviewer
A
B
C
D
E
Review the certificate of calibration testing for the temperature monitoring device in this section of the storage unit and answer the questions below
bull How to determine certificate of calibration testing expiration date 1) Identify the certificate issuecalibration date 2) Apply the Immunization Program-required frequency for calibration testing Example If the
issuecalibration date is 12312013 and Immunization Program policy requires testing every twoyears the expiration date is 12312015
bull Certificates must include all of the below bull ModelDevice Name or Number bull Serial Number bull Date of Calibration Testing (Report or Issue Date) bull Instrument Passed testing (Instrument in Tolerance)
Is there a certificate of calibration testing for the temperature monitoring Yes device in this section of the storage unit No [X]
What is the date of calibration for the temperature monitoring device in this section of the storage unit
What is the certificatersquos date of expiration based on ImmunizationProgram policy (See note to reviewer to determine expiration date) [X] Follow-up is required if
certificate is expired
Does the certificate contain all the necessary items listed in the Note to Yes Reviewer No [X]
Who is responsible for supplying the current and valid certificate of Provider calibration for this temperature monitoring device
Date of calibration testing (report or issue date) Note If there is no expiration date the certificate expires 2 years from the date of calibration Whether the instrument passed or failed testing (or instrument in tolerancenot in tolerance)
bull Recommended element Documented uncertainty of +- 1degF [05degC]
If these elements are present the certificate is considered valid If the certificate contains information about the recommended element or the entity that issued the certificate that is helpful but not required
To determine if a certificate of calibration testing was issued by an appropriate entity check to see if the certificate indicates one or more of these items (this is the wording used to help sites evaluate if their calibration is accurate but is not required on the certificate itself to be considered valid)
bull Conforms to ISO 17025 bull Performed by an ILACMRA Signatory body accredited laboratory You can review this list of the ILAC MRA and Signatories (httpilacorgilac-mra-and-signatories)
bull Traceable to the standards maintained by NIST bull Meets specifications and testing requirements for the American Society for Testing and Materials (ASTM) Standard E2877 tolerance Class F (le 05 degC) or better
bull Includes reference to another acceptable accuracy validation method such as comparison to other traceable reference standards or tests at thermometric fixed points
Note CDC recommends that certifications be issued for the entire monitoring unit (detachable probe data logger etc) and not individual certificates for each component
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The 2017 MnVFC Site Visit Paperwork Chapter 4
For 45 E the provider is always responsible for supplying the current and valid certificate of calibration for a temperature monitoring device
bull Tip If the temperature monitoring device has a sticker on the back with the calibration date the site can usually call the company who calibrated the device and get a copy of the certificate if they donrsquot have one
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 46 4 Storage amp Handling Per Unit Probe Placement
Question 46 Is the probe properly placed in this section of the storage unit
Note to Reviewer ldquoProperlyrdquo means that the probe in a commercial or household unit is placed in a central area of the unitdirectly with the vaccines Probes should not be placed in the doors near or against the walls close to vents or on the floor of the unit The only allowable exemption related to this requirement is for providerswho have pharmaceutical storage units (built for vaccine storage) that have either (1) a built-intemperature monitoring device OR (2) a dedicated port for the probe that dictates the placement of theprobe
Answers (Choose one)
Yes No [X]
Review CDC Requirement
The probe must be placed in a central area of the section of the storage unit directly with the vaccines in order to properly measurevaccine temperature The probe should not be placed in the door near or against the walls close to vents or on the floor of theunit For pharmaceutical units with a built-in temperature monitoring device or a dedicated port for a probe that is not in thecenter of the section of the storage unit consult your Immunization Program for guidance on placement
Goal of this question Make sure the temperature monitoring device is in the best location to accurately measure the temperature of the vaccines stored in the unit
Helpful information bull The probe of the temperature monitoring device should be placed directly with the vaccines in the middle of the unit The ONLY allowable exception is for pharmaceutical storage units that have either a built-in thermometer or a dedicated port for the probe that indicates placement of the probe
bull Temperatures can vary within the unit especially household units bull Call MDH at 651-201-5522 if you have questions
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Guide (wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml)
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Question 474 Storage amp Handling Per Unit Temperature Documentation
Question 47 Review the temperature documentation over the past three months for this section of the storage unit todetermine whether the provider has a process in place for properly documenting temperatures twice aday Answer the questions below
A Are there two temperature readings recorded for this section of the storage unit per day
Yes No [X]
B Is there a time date and name (or initials) recorded for each reading Yes No [X]
C What is the current temperature and minmax temperatures (if available) inthis section of the storage unit Use the reviewerrsquos thermometer if the providerrsquos temperature monitoringdevice does not have a current valid certificate of calibration testing or the probe is not properly placed in this section of the storage unit
Current Temperature Minimum Temperature Maximum Temperature Fahrenheit Celsius
D Based on your review of the providerrsquos recent temperature documentationincluding the current temperature is this section of the storage unitmaintaining appropriate temperatures
Yes No [X] Not enough information [X]
Review CDC Requirement
Vaccines must be stored under appropriate temperatures as described in the package inserts at all times Acceptable temperature ranges vary by vaccine type and the range is 36deg F and 46deg F (2deg C and 8deg C) and for frozen vaccines the range is -58deg F and +5deg F (shy50deg C and -15deg C) Exposure to temperatures outside of those included in the package inserts could affect vaccine viability andultimately could leave children unprotected against vaccine-preventable diseases In order to maintain awareness of storage unittemperatures and ensure that vaccines are being stored at appropriate temperatures at all times VFC providers are required to monitor and document temperatures for all vaccine storage units at least twice a day Temperature documentation must contain (1) at least two temperature readings per day (2) the time and date of each reading and (3) the name (or initials) of the personwho assessed and recorded the readings CDC also recommends that VFC providers record the minimum and maximumtemperatures of each unit once each workday (preferably in the morning)
Goal of this question Ensure the temperature is being monitored twice daily is within the required range and documented correctly Use your thermometer to check the temperature if the sitersquos temperature monitoring devicersquos probe is not properly placed or there is not a current certificate of calibration Place your thermometer in the unit at the beginning of the visit to allow sufficient time to reach an accurate temperature The purpose of using your thermometer is to ensure the vaccine is being stored at the proper temperature not to ldquovalidaterdquo their reading
Question 47 D is an assessment question based on information you have learned during your visit You might answer ldquonot enough informationrdquo if the unit is new and they donrsquot have at least three months of data or if the unit is only used as overflow and they are inconsistent with temperature monitoring Mark ldquoNordquo if you have reason to believe the storage unit is not maintaining temperatures properly
Helpful information bull All sites must document temperatures twice a day every day the site is open even if they have a data logger or continuous monitoring system
bull Sites can document the information electronically with some continuous monitoring systems as long as it can show what the current temp is the date time and initials of the person checking ndash this needs to be someone at the site ndash not checking remotely or centrally for a large site or system The site must be able to produce these records during their site visit Reviewing these files can be a challenge due to large volumes and lots of paper
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Temperature Logs on Managing Vaccine (wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml)
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The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 484 Storage amp Handling Per Unit Temperature Excursions
Question 48 In the event that a temperature excursion(s) occurred in this unit within the last three months requestand review documentation of actions taken to determine whether the provider has a process for properlyaddressing excursions Answer the questions below
A Were vaccines in this unit exposed to out-of-range temperatures in the lastthree months (including today)
Yes No (If no skip to question 49)
B Did the provider quarantine and label vaccines as ldquoDo not userdquo Yes No [X]
C Did the provider place vaccine in a unit where it can be stored under properconditions if applicable
Yes No [X]
D Did the provider contact the Immunization Program to report theexcursion
Yes No [X]
E Was the manufacturer contacted for documentation supporting theusability of the vaccine
Yes No [X]
Review CDC Requirement
The provider must document all excursions and actions taken including the following (1) Quarantine and label vaccines as ldquoDO NOTUSErdquo (2) Place vaccines in a unit where they can be stored under proper conditions (3) Contact the Immunization Program to report an excursion and (4) Contact the vaccine manufacturer to obtain documentation supporting the usability of the vaccine
Goal of this question Address any out-of-range temperatures (temperature excursions) identified in reviewing the last three months of temperature logs or during the site visit If there were any out-of-range temperatures did the site respond appropriately to the situation This is a great opportunity to discuss what to do in the event of an excursion The Clinicians Storage and Handling Mishap Checklist is in the IPI Site Visit information folder and is a good review of the process
Helpful information bull Sites need to know that an excursion does not automatically mean that exposed vaccines are non-viable or unusable Exposed vaccines must be quarantined (marked ldquoDo Not Userdquo) and stored under proper conditions until they have received information from vaccine manufacturers regarding the viability of the vaccine
bull Sites must inform MDH when an excursion occurs
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Clinicians Storage and Handling Mishap Checklist (wwwhealthstatemnusdivsidepcimmunize ipivaxchklstpdf)
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Question 49
Goal of this question Ensure proper placement of vaccines in the storage unit
Note These are all recommendations (best practices) not requirements
Helpful information bull Store vaccine in the middle of the compartment two to three inches away from the coils walls floor and cold air vent The temperature near the floor and walls of the unit differs from that in the middle of the compartment and the cold air vent can freeze refrigerated vaccines
4 Storage amp Handling Per Unit Vaccine Placement
Question 49 Look inside the unit to answer the questions below
A Are vaccines placed in the middle of the unit with space between vaccinesand the sideback of the unit to allow cold air to circulate
Yes No [O]
B Are vaccines stored in their original packages Yes No [O]
C Are there water bottles (for refrigerators) or frozen water bottles (forfreezers) in the unit
Yes No [O]
D Are vaccines store in the doors vegetable bins under or near cooling ventsor on the floor of the unit
Yes [O] No
E Is food being stored in the unit Yes [O] No
Review CDC Recommendation
Vaccines should be stored in their original manufacturer (or CDC centralized distributor) packaging They should be placed in the middle of the unit with space between the vaccines and the sideback of the unit to allow cold air to circulate Vaccines SHOULD NOT be stored in the doors vegetable bins or floor of the unit or under or near cooling vents and there should not be any food inthe unit Water bottles (for refrigerators) or frozen water bottles (for freezers) should be placed throughout each storage unit inorder to (1) stabilize or extend temperatures during a power outage and (2) to serve as physical blocks preventing the placementof vaccines in areas of the unit that are at higher risk for temperature excursions (such as in doors vegetable bins floor ornearunder cooling vents)
bull Vaccines should be kept in their original packaging to Protect them from light Help prevent medication errors by making labels easier to read Provide a moisture barrier that serves as insulation in case of an out-of-range temperature power outage door left open or mechanical failure Simplify managing vaccine inventory
bull Store water bottles in the doors on the floor and near the cold air vent in the refrigerator and frozen water bottles in the freezer to help maintain a stable temperature if there is a power failure and when the door is opened frequently Too many water bottles in the door can prevent the door from closing tightly Mark water bottles ldquoDo Not Drinkrdquo
bull Do not store vaccine in the door or drawers of the refrigerator or freezer Vegetable bins and crisper drawers should be removed from refrigerators or used to store other medical supplies or water bottles
bull If vaccine is stored in a household combination refrigeratorfreezer The top shelf should not be used for storing vaccine because the cold air vent blowing from the freezer will freeze vaccine located there If you must use the top shelf of this type of unit place water bottles underneath the cold air vent to prevent vaccine from being stored there It is recommended that only the refrigerator be used for vaccine storage and a separate stand-alone freezer be used to store frozen vaccine
bull Must not store food or beverages in the refrigerator or freezer because frequent opening of doors can lead to temperature variations that may affect vaccine viability There is also a risk of contaminating vaccines
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Guide (wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml) bull Vaccine Storage Tip Sheet on IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml)
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The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 4104 Storage amp Handling Per Unit Disconnection from Power Source
Question 410 Ask the provider to demonstrate what measures are taken to ensure that vaccine storage units are notaccidentally physically disconnected from the power supply Which of the following describes the measure(s) taken on this unit
Note to Reviewer bull Large hospitals and healthcare systems may not have the ability to demonstrate labels on plugs or circuitbreakers In such cases verify that the practice has a comprehensive policy and standard operatingprocedures in place to prevent the vaccine storage unit from being physically disconnected from thepower supply
bull While back-up generators may ensure power to the overall facility this question ONLY addresses thevaccine storage unit being accidentally disconnected from the power source either through the plug orthe circuit breaker
Answers A ldquoDo not disconnectrdquo labels on the plug (Choose all that B ldquoWarningrdquo label on the circuit breaker box
apply) C Hard-wired (ie built-in) and has a ldquoDo not disconnectrdquo label on thecircuit breaker box D Hospital or large health care system with a comprehensive written policyand standard operating procedures detailing measures taken to preventvaccine storage units from being accidentally disconnected from the powersupply E No acceptable measures for preventing accidental disconnection frompower supply [X]
[X] The response is non-compliant if only A only B or E is selected
Review CDC Requirement
VFC providers must take steps to protect the power source for all vaccine storage equipment by means of having clear warninglabels on both the plug and the circuit breaker associated with all vaccine storage units Large hospitals and healthcare systems canmeet this requirement by demonstrating that they have comprehensive policies and standard operating procedures to preventvaccine storage units from being physically disconnected from the power supply
Goal of this question Decrease the chance that a vaccine storage unit will be accidently unplugged or power will be turned off while vaccine is in the unit This question addresses only what measures the site has taken to ensure the storage unit is not physically disconnected from its power source
If the site uses labels on the plugs and circuit breakers perform a visual inspection to assess whether the way the stickers are positioned make it clear and obvious to anyone that these units are not to be disconnected
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Do Not Unplug and Warning stickers are included in the folder or available to order on the For
Professionals Order Form (wwwhealthstatemnusdivsidepcimmunizeordermathtml)
Note Once you have completed the 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet for each unit return to the questionnaire to complete sections 5 and 6
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The 2017 MnVFC Site Visit Paperwork Chapter 4
-
- -
Section 5 Storage amp Handling Site-Wide Question 51
5 Storage amp Handling Site Wide Discussion of Cost amp Quantity of Vaccine
Question 51 Have a discussion with the provider about the cost and quantity of VFC vaccines they are responsible for annually Address the points listed in the note to reviewer below
Note to Reviewer bull Vaccine Shipped (Required) Share the cost of VFC vaccines shipped to the provider in the last calendaryear to make sure the provider understands the contribution made by the VFC Program to their practiceFor new providers who do not have ldquocalendar yearrdquo data share either the actual cost of their currentinventory or use the cost of 10 VFC doses of each of the ACIP-recommended vaccines (approximately $7000) to help estimate their annual cost
bull Storage amp Handling (Required) Make sure the provider understands the cost of vaccines for which they are responsible when they make decisions about purchasing recommended vaccine storage and temperature monitoring equipment
Answer I have discussed with the provider the cost and quantity of vaccines ordered in the previous calendar year
Goal of this question Inform sites of the quantity and value of vaccines that they receive as part of the MnVFC program Providers often donrsquot realize the value of the vaccine in their unit This information is included on your clinic list and on the one page site-specific information
Helpful information bull This discussion must occur and the box on the questionnaire must be checked bull If there isnrsquot actual vaccine value information available tell the site that one vaccine order that includes a box of each of the ACIP recommended vaccines costs approximately $7000
bull MDH may not have specific information for individual sites if they receive vaccine from a central warehouse or pharmacy For those sites MDH will give you numbers for the whole system so you can discuss system wide data as appropriate If individual site information is also included it is usually just varicella-containing vaccines that must be shipped directly to the site
Question 52
5 Storage amp Handling Site Wide Dorm Style Units
Question 52 Determine whether the provider has any dorm-style units on site and answer the questions below
Note to Reviewer A dormitory-style refrigerator is a unit that has both refrigerator and freezer compartments behind a singleexterior door Dorm-style units also have an evaporator plate (cooling coil) which is usually located insidean icemaker compartment (freezer) within the refrigerator
A Does the provider have any dorm-style units that are used at any time tostore vaccines
Yes [X] No (Skip to question 53)
B Does the provider have sufficient space in existing compliant vaccinestorage units to store all vaccines without use of the dorm-style unit at any time
Yes No [X]
Review CDC Requirement
Dorm- and bar-style units are prohibited for vaccine storage Vaccines stored in dorm-style units are considered non-viable and must be returned to the centralized distributor CDC recommends the following vaccine storage unit types (in order of preference)pharmaceutical grade stand-alone or combination units (preferred) householdcommercial stand-alone unitshouseholdcommercial combination units using the refrigerator section only
Goal of this question Ensure no vaccine is stored in dorm-style units even for short periods of time Encourage them to label any units ldquoNo Vaccine Storage Allowedrdquo Vaccine stored in these units is considered non-viable If a site is using a dorm-style unit call the MnVFC program (651-201-5522)
Resource Section 8 in the MnVFC Policies and Procedures Manual
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-
Question 535 Storage amp Handling Site Wide Storage Unit Space Availability
Question 53 Does the provider have sufficient room across storage units to store current stock as well as anyadditional stock acquired during peak season without overcrowding
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have sufficient storage space to accommodate vaccine stock at the busiest time of year without overcrowding
Goal of this question Ensure that sites have sufficient space in their units to maintain vaccines at the busiest time of year Overcrowding of vaccine limits air circulation and affects the unitrsquos ability to maintain stable temperatures
Helpful information bull Look for signs of overcrowding such as vaccines that are pushed up against the wall bins that are overflowing or storage units that are full during non-peak seasons
Discuss immediate actions if the unit is overcrowded Move some of their vaccines order less vaccine more frequently (once per month preferably) andor purchase another storage unit for overflow
Resource bull Section 8 MnVFC Policy and Procedure Manual
Page 44 IPI Advisor Manual | February 2017
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-
Question 545 Storage amp Handling Site Wide Expired Vaccines
Question 54 Look in each unit Are there expired vaccines in any of the vaccine storage units at this site
Answers (Choose one)
Yes [X] No
Review CDC Requirement
Vaccines should be rotated weekly and when a new shipment comes in so that longer-dated vaccines are stored behind shorter-dated vaccines If vaccines expire they can no longer be stored in the same storage unit with viable vaccines They must be placedin a container or bag clearly labeled ldquoDo not userdquo and separated from viable vaccines to prevent inadvertent use Expired vaccinemust be returned to the centralized distributor within six months of expiration
Goal of this question Ensure there is no expired vaccine in any storage unit
Helpful information bull Sites can prevent their stock from expiring by rotating vaccines every week andor when a new shipment arrives Longer-dated vaccines are stored towards the back of the unit and shorter-dated vaccines are up front
bull Pay attention to vaccines that expire within the next three months Consider transferring vaccine that will expire soon to another MnVFC-enrolled site that will use the vaccine preferably a site close by It is the transferring sitersquos responsibility to arrange the transfer of the vaccine Be sure to complete the MDH Vaccine Transfer Record form and send it to MDH If they are having difficulty finding a location to accept vaccine contact MDH
bull This is a great opportunity to educate sites about the MDH Nonviable Vaccine Form and the process for returning vaccine The VFC program does get some credit for taxes and fees on vaccine that is returned to the distribution center
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MDH Nonviable Vaccine Form and MDH Vaccine Transfer Record on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfcformshtml)
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The 2017 MnVFC Site Visit Paperwork Chapter 4
- -
-
Question 555 Storage amp Handling Site Wide Back up Thermometer
Question 55 Does the provider have a readily available back-up thermometer with a current and valid certificate ofcalibration testing
Note to Reviewer ldquoReadily availablerdquo means that the thermometer is available to perform twice-a-day monitoring for a unit asrequired CDC recommends that the back-up thermometer be maintained on site
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have a readily available back-up thermometer with a current and valid certificate of calibration testing Toprevent the certificates of calibration testing of the primary and back-up thermometers from expiring at the same time the date of calibration testing (or issue date) of the back-up thermometer should be different from the date of calibration testing (or issue date) of the primary thermometer As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meetsVFC program requirements
Goal of this question Ensure sites have one calibrated back-up thermometer onsite that is readily available in the event that the temperature monitoring device in unit fails transportation of vaccine is needed or there are other unexpected circumstances
Helpful information bull As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meets VFC Program requirements
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 56 5 Storage amp Handling Site Wide Preparation of Vaccine
Question 56 When does this provider prepare vaccine for administration to the patient
Note to Reviewer For mass vaccination clinics if one type of vaccine is offered providers may pre-draw up to 10 doses Ifusing pre-filled syringes pre-drawing also means activating the syringe by removing the needle guard orattaching a needle
Answers (Choose all that
apply)
Prepare dose immediately before administration Pre-draw doses for upcoming patients (in a regular clinicpractice) [O] Pre-draw up to 10 doses (in a mass-vaccination clinic) Pre-draw more than 10 doses (in a mass-vaccination clinic) [O] Other [O]
Review CDC Recommendation
CDC recommends preparing vaccines immediately prior to administration in order to assure viability of vaccine and prevent vaccinewastage Vaccines that are not administered immediately are at risk of exposure to temperatures outside of the required rangewhich can affect vaccine viability and ultimately can leave children unprotected against vaccine-preventable diseases
Goal of this question Discuss proper timing and preparation of vaccine(s) for administration These are recommendations not requirements
Helpful information bull Educate staff on the importance of preparing vaccine immediately before administration Pre-drawing of vaccines may lead to concerns related to vaccine viability potency sterility and wastage
Page 46 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 6 Inventory Question 61
6 Inventory Inventory Comparison
Question 61 Visually inspect storage units to determine if existing supply of vaccines proportionately mirrorspopulations served Choose the most accurate statement below
Note to Reviewer bull CDC recommends that providers maintain a four-week supply of inventory bull For this question do not take into account vaccine types that the provider does not order Here simply
make sure that overall the vaccines in the providerrsquos storage units are available in sufficient amounts toserve their patient population
Answers (Choose one)
The current vaccine inventory proportionately reflects the populations identified Only public stock is insufficient [X] Only private stock is insufficient [X] Both public and private stock are insufficient [X] Site uses the replacement method but does not appear to have enough vaccine for their population [X] Other [X]
Review CDC Requirement
VFC providers must order and stock routine vaccines in accordance with their patient population in order to prevent missedvaccination opportunities Having sufficient amounts of all stocks prevents the inadvertent use of VFC vaccines for non-VFC-eligiblepatients and vice versa
Goal of this question Assess whether the site is ordering appropriate quantities of vaccine for the population they serve at their site
Helpful information bull If the site sees 30 percent private-pay patients and 70 percent VFC the stock in their storage units should reflect that proportion If you donrsquot know you can ask the site about their population
bull This is meant to be a general assessment so in a big site if they have only a small amount of vaccine that may indicate an issue with vaccine management
bull CDC recommends smaller more frequent orders (ie monthly) rather than large orders to minimize the amount of vaccine loss if an incident occurs during shipment or in the storage unit Sites should not order more frequently than once a month
bull Sites using the replacement method will only have one stock but it should appear to be large enough for their population
bull Only assess the vaccine types that the site currently stocks in their unit We know there are sites that do not offer all ACIP-recommended vaccines for various reasons That issue will be addressed in question 62
IPI Advisor Manual | February 2017 Page 47
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 626 Inventory ACIP Recommended Vaccines
Question 62 Review providerrsquos current inventory to answer the questions below
A Does the provider offer all routine ACIP-recommendedvaccines for their patient population
Yes (Skip to question C) No [X] Offers all except varicella because direct ship ofvaccine is unavailable from manufacturer
B Which routine vaccines are NOT being offered DTaP Hepatitis A Hepatitis B HIB HPV Influenza Meningococcal
MMR Pneumococcal Polio Rotavirus TdapTd Varicella
C According to Immunization Program Policy does theprovider make accessible all non-routine ACIP-recommended vaccines for those VFC patients whomeet the criteria for receiving them
Yes (Skip to question 63) No [X]
D Which non-routine vaccines are NOT being offered Pneumococcal polysaccharide vaccine (PPSV23) Meningococcal Group B (MenB) Other
Review CDC Requirement
VFC providers agree to comply with immunization schedules dosages and contraindications that are established by the Advisory Committee on Immunization Practices (ACIP) for the vaccines identified and agreed upon in the Provider Agreement UNLESS bull In the VFC providers medical judgment and in accordance with accepted medical practice the VFC provider deems such
compliance to be medically inappropriate for the child bull The particular requirements contradict state law including laws pertaining to religious and other exemptions The VFC program entitles children to the following vaccines DTaP Hepatitis A Hepatitis B HIB HPV Influenza MeningococcalMMR Pneumococcal Polio Rotavirus TdapTd and Varicella VFC providers are also required to ensure that VFC-eligible children have access to non-routine vaccines as needed
Goal of this question Assess if the site is offering all the ACIP-recommended vaccines for the population they serve and these vaccines are in stock on the day of the visit It is important that every MnVFC-eligible child that comes to a providerrsquos office for an immunization is vaccinated
Helpful information bull The Advisory Committee on Immunization Practices (ACIP) is a group of medical and public health experts that develops recommendations on how to use vaccines to control diseases in the United States
bull Specialty providers are not required to offer all routine vaccines but should provide the vaccines appropriate for their population
bull If the site does not offer all routine ACIP-recommended vaccines appropriate for their population check the ldquoNordquo box in Part A then check the appropriate box(es) in Part B for any vaccines not offered Please contact MDH as this situation offers us the opportunity to provide education to the site
bull For non-routine vaccines they must either be in stock or the site must have an alternative protocol in the routine management plan that ensures these children have access when applicable
Resources bull IAC Diseases and Vaccines (wwwimmunizeorgvaccines) bull CDC Advisory Committee on Immunization Practices (ACIP) (wwwcdcgovvaccinesacipindexhtml)
Page 48 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 636 Inventory Separation of Stock
Question 63 Observe how the provider differentiates stock in each storage unit to answer the questions below
A Is it clear which vaccines belong to public stock andwhich belong to private stock
Yes No [X] Not applicable replacement site
B Is it clear which vaccines belong to VFC stock andwhich belong to UUAV stock
Yes No [X] Not applicable replacement site Not applicable not UUAV-enrolled site
Review CDC Requirement
In order to ensure that VFC vaccines are only administered to VFC-eligible children VFC providers that serve both VFC and non-VFCshyeligible children must maintain their vaccine inventories in such a way that they can clearly differentiate public stock from privatestock as well as VFC from other public stock
Goal of this question Assess whether the site can distinguish between MnVFC vaccine and private vaccine If they participate in the Uninsured and Underinsured Adult Vaccine (UUAV) program they should also be able to distinguish between MnVFC stock and UUAV stock Some sites use labels bins boxes etc to differentiate their stock If it is not clear how the site differentiates their stock discuss vaccine management with the staff For follow-up call MDH to discuss doing a follow-up site visit
Sites using the replacement method will not have separate stocksmdashthis is an approved alternative method for keeping track of vaccine
Resource bull Section 10 of the MnVFC Policy and Procedure Manual
IPI Advisor Manual | February 2017 Page 49
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
MnVFC Site Visit Storage and Handling Per Unit Answer Sheet 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet MnVFC PIN ___________________
Question number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
Temperature Monitoring Device Questions Questions 43 47 must be answered separately for the freezer and refrigerator if the unit is a combo Be sure to document responses in the appropriate column
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
All the questions on the Site Visit Storage amp Handling Per Unit Answer Sheet have been discussed previously in section 4 of this manual Use this sheet to record information about all the units at the site visit You will need one sheet for each unit If it is a combination unit (either pharmaceutical or household) you can record both sections on one sheet If they have stand-alone units use one sheet for each unit Do not enter the answers to the questions in section 4 of the questionnaire
If you need more information about any of the questions refer back to the main questionnairemdashthe complete question additional guidance including notes to the reviewer and the CDC requirements are there Also if the site is not meeting the requirement you will go back to the questionnaire to complete the ldquoActions if Non-compliantrdquo section including the root cause analysis and follow-up sections
When you have completed the assessment of all the storage units remember to go back to the questionnaire to complete sections 5 and 6
Page 50 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
ndash
ndash
MnVFC Provider Follow-up PlanThe goal of the Provider Follow-up Plan is to communicate with the site all of the VFC requirements any unmet requirements found during your site visit and the timeline for completing the required action The left hand column is a box to check for ldquoUnmetrdquo requirements
Helpful information bull The form can be used to review what the site is doing well and what they need to work on
bull For requirements that have specific documentation that needs to be sent to you use the notes section
2017 MnVFC Provider Follow-up Plan Site _______________________________________________ MnVFC PIN ____________ Date of Visit ___________
Thank you for participating in this MnVFC compliance site visit Please review this visit summary including follow-up actions and timelines for completion Unmet MnVFC requirements and recommendations have a checked box next to them The goal of this plan is to support you with successfully implementing the program and improving access to vaccines for VFC-eligible children
Unmet Question VFC Requirements Section 1 Changes to Key Staff
Q12 Change in the Medical Director Immunization Manager Vaccine Coordinator or back-upKey Staff must be communicated to the immunization program by emailing healthmnvfcstatemnus Changes Notes
Q12 Key staff must complete the annual training on VFC program requirements and print theAnnual Training certificate of completion Documentation Required Action
Staff that have not completed the MnVFC online training must complete it and send acopy of the certificate to the reviewer Training can be found on the MnVFC website (wwwhealthstatemnusvfc) Due date 1 month
Notes
Unmet Question VFC Requirements Section 2 Eligibility
Q21 Provider staff must possess a working knowledge of all VFC eligibility criteria and use thoseVFC Eligibility criteria to screen children prior to administering VFC vaccines
Categories Notes
bull This form provides documentation needed for follow-up actions when you send your thank you email
The second to last page of the Provider Follow-up Plan has a summary of the MnVFC program recommendations These are to remind the site about best practices they may want to improve upon even though they are not yet requirements of the program For example you could discuss the recommendation about storage units if they currently have a combination household unit and are using both sections
The last section is for your signature and the person you met with In most sites it will be the immunization manager or vaccine coordinator who signs the form unless the medical director attended the site visit You keep the original copy and the site will need to keep a copy for themselves
To be completed by the site visit reviewer
I acknowledge that a VFC site visit was performed on __________________ (visit date) The follow-up plan which includes a list of all current VFC program requirements and recommendations assessed during the visit and any required follow-up actions was provided at the end of the visit
Site visit reviewer
Phone
Reviewer Signature Date
To be completed by the provider
I acknowledge that our practice took part in the VFC site visit noted above I understand the findings of the visit and any required actions that must be taken by our office in order to meet VFC program requirements
Medical Director (or designee) Name Title
Medical Director (or designee) Signature Date
IPI Advisor Manual | February 2017 Page 51
The 2017 MnVFC Site Visit Paperwork Chapter 4
After the Site Visit Send a thank you email highlighting the unmet requirements documents you need from the site to resolve the issue(s) and the date you need them Make sure to include the link to the Site Visit Survey (httpssurveyvovicicomseashxs=56206EE334CE0B14)
Please refer to Chapter 3 for more information about future follow-up required after the visit including forms and documentation
Resource bull Sample Thank You letter on IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml)
Chapter 5
IPI Advisor Resource List MnVFC Program 651-201-5522
MnVFC wwwhealthstatemnusvfc
bull Separate Stock and Replacement Method Policies and Procedures Manuals bull Online trainings bull MnVFC Announcements sign up to receive them via email bull Ordering MDH vaccine bull MnVFC forms Screening forms Reporting forms Others MDH Nonviable Vaccine Form MDH Vaccine Transfer Record and Vaccine Borrowing Report
bull MnVFC promotional materials bull Immunization Billing Guidance for MnVFC and Immunization Billing Guidance for MnVFC Replacement Sites Immunization Practices Improvement Program (IPI) wwwhealthstatemnusdivsidepcimmunizeipi
bull IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml) bull IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml) IPI Resource Folder Contents (wwwhealthstatemnusdivsidepcimmunizeipiipifolderpdf)
Minnesota Immunization Information Connection (MIIC) wwwhealthstatemnusmiic
bull MIIC regions and regional coordinators
Clinical Practice MDH Immunization Program wwwhealthstatemnusimmunize
Got Your Shots News wwwhealthstatemnusdivsidepcnewslettersgys
MDH Immunization Information for Health Care Providers wwwhealthstatemnusdivsidepcimmunizehcp
bull Got Your Shots A Providers Guide to Immunization in Minnesota bull Vaccine protocols bull Forms for tracking patient immunizations bull Immunization schedules for Health Care Providers Immunization Action Coalition (IAC) wwwimmunizeorg
bull Ask the Experts bull VISs (Vaccine Information Statements and translations) bull Administration screening questions bull Medical management of vaccine reactions bull Order form for Californiarsquos Immunization Technique DVD Best Practices with Infants Children and Adults
Page 52 IPI Advisor Manual| February 2017
IPI Advisor Resource List Chapter 5
CDC ldquoPink Bookrdquo wwwcdcgovvaccinespubspinkbookindexhtml
CDC Advisory Committee on Immunization Practices (ACIP) wwwcdcgovvaccinesacip
CDC Vaccines and Immunizations wwwcdcgovvaccines
VAERS reporting httpvaershhsgovindex
Storage and Handling Got Your Shots Providers Guide ndash Managing Vaccine wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml
MnVFC Guide to Temperature Monitoring Devices wwwhealthstatemnusvfc
MDH Clinicianrsquos Vaccine Mishap Checklist wwwhealthstatemnusdivsidepcimmunizeipivaxchklstpdf
MDH Vaccine Storage Guide wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml
CDC Vaccine Storage and Handling Toolkit wwwcdcgovvaccinesrecsstoragetoolkit
You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Vaccine manufacturer phone numbers wwwcdcgovvaccinespubspinkbookdownloadsappendicesFcontact-info-manufactpdf
IAC Checklist for Safe Vaccine Handling and Storage wwwimmunizeorgcatgdp3035pdf
IAC Donrsquot Be Guilty of These Errors in Vaccine Storage and Handling wwwimmunizeorgcatgdp3036pdf
Additional Resources Print materials from MDH ndash order forms wwwhealthstatemnusdivsidepcimmunizeordermathtml
Vaccine Education Center ndash Childrenrsquos Hospital of Philadelphia wwwchopeduservicevaccine-education-centerhomehtml
California Department of Public Health ndash Interactive training on vaccine administration and storage and handling handout on transporting vaccine and how to package wwwezizorg
IPI Advisor Manual | February 2017 Page 53
IPI Advisor Resource List Chapter 5
CDC vaccine price list wwwcdcgovvaccinesprogramsvfcawardeesvaccine-managementprice-listindexhtml
Vaccine Information Statements (VIS) wwwcdcgovvaccineshcpvisindexhtml
CEU Opportunities CDC Immunization Education and Training wwwcdcgovvaccinesedindexhtml
Immunization You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Page 54 IPI Advisor Manual| February 2017
- Introduction
-
- Welcome to the Immunization Practice Improvement (IPI) Program
- Contact Information
-
- Chapter 1
- Requirements to Participate in the MnVFC Program
- Vaccines for Children Program
- Chapter 2
- Reimbursement for MnVFC Visits
- Types of Visits
- Your MnVFC Clinical CoordinatorPlanner
- New IPI Advisor Training Requirements
- Your Role as an IPI Advisor
- Reasons MDH Would Do All or Part of a Visit
- Chapter 3
- Future follow-up
- Conducting the Visit
- Preparing for the Visit
- Information for the Visit
- Site Visit Checklist
- Scheduling the Visit
- Chapter 4
- After the Site Visit
- MnVFC Provider Follow-up Plan
- MnVFC Site Visit Storage and Handling Per Unit Answer Sheet
- Section 6 Inventory
- Section 5 Storage amp Handling Site-Wide
- Section 4 Storage amp Handling Per Unit
- Section 3 Documentation
- Section 2 Eligibility
- Section 1 Provider Details
- The Site Visit Reviewer Legend
- MnVFC Site Visit Questionnaire
- Required Paperwork for Site Visits
- Chapter 5
-
Page 20 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 12
1 Provider Details Changes to Key Staff
Question 12 Ask the provider about changes to key staff to answer the questions below
A (Choose all that
apply)
At the time of the visit is the Medical Director the same individual that signed the ProviderAgreement and are the Immunization Manager and Vaccine Coordinator the same asthose last reported to the program
Yes No the Medical Director has changed No the Immunization Manager has changed No the Vaccine Coordinator has changed
B (Choose one)
Were all changes communicated to theImmunization Program according to yourprogramrsquos policy
Yes or no staff changes No [X]
C (Choose one)
Based on review of the trainingdocumentation have the current Immunization Manager Vaccine Coordinator and back-up completed all required training
Yes No [X]
Review CDC Requirement
All changes in key staff must be communicated to the Immunization Program in the manner and timeframe defined by theImmunization Program Key staff include the Medical Director or equivalent who signed the Provider Agreement the Immunization Manager Vaccine Coordinator and the back-up VFC providers are required to ensure that all key staff are fully trained on VFC program requirements at all times All training must be documented
Goal of this question Determine if there are new staff in key positions at the site and to make sure staff are properly educated about the MnVFC program A This information can help you determine the level of knowledge and experience the staff have with the MnVFC program Follow-up throughout the visit can be tailored for various levels of staff experience Likewise you may identify additional training needs for new staff
B When sites notify us of changes in key personnel we update their information in MIIC and on the clinic lists We also send the new staff information for completing the online training and direct them to read the appropriate MnVFC Policies and Procedures Manual If the answer to this part is no update the demographic area of the questionnaire and inform the staff that in the future they must notify the MnVFC program (via email or phone) if the immunization manager or vaccine coordinator changes Resource Section 12 of the MnVFC Policies and Procedures Manual
C Annual training must be verified by looking at the certificates for the online training If the answer to this part is no refer the staff to complete the appropriate MnVFC online training found on the MnVFC website (wwwhealthstatemnusvfc) for their program (separate stockreplacement) for the current year and send you a copy of the certificate within 30 days
Resource bull Sections 12 and 14 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 21
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 2 Eligibility Question 21
Goal of this Question Assess whether staff correctly understand which patients are eligible for the MnVFC program Screening ensures that eligible children receive the vaccines that they are entitled to receive under the MnVFC program and helps to prevent fraud or abuse of the program
Children 18 years and younger in these
categories can receive MnVFC vaccine at any enrolled site bull Uninsured bull Enrolled in a Minnesota Health Care Program (MHCP) Medical Assistance (MA) or MinnesotaCare bull American Indian or Alaskan Native
The following categories are considered underinsured and are only MnVFC-eligible at local public health (LPH) Federally Qualified Health Centers (FQHC) Rural Health Centers (RHC) Indian Health Services (IHS) and tribal health clinics
bull Has health insurance that does not cover one or more vaccines as can be the case with newly licensed vaccines that arenrsquot yet covered (MnVFC-eligible for non-covered vaccines only)
bull Has health insurance that caps vaccine coverage at a certain amount Once that amount is reached the child is MnVFC-eligible
Children with insurance that does not cover vaccines until a deductible has been met are considered to be fully insured and are not MnVFC-eligible
Helpful information bull Sites are not required to verify the patientrsquos response to the screening questions For example if a patient states they lost their insurance the site does not need to call the patientrsquos insurance company to confirm
If the site cannot correctly describe the eligibility categories provide educational materialsresources on MnVFC eligibility requirements
Resources bull Patient Eligibility Screening Record on MnVFC Forms (wwwhealthstatemnusdivsidepc immunizemnvfcformshtml)
bull Section 1 of the MnVFC Policies and Procedures Manual
2 Eligibility VFC Eligibility Categories
Question 21 Was the individual responsible for determining patient VFC eligibility able to explain all the factors(including age) that make a child eligible to receive VFC vaccines
A Patient is less than 19 years of age Yes No [X]
B Patient is Medicaid-eligible Yes No [X]
C Patient is uninsured Yes No [X]
D Patient is underinsured Yes No [X]
E Patient is American Indian Yes No [X]
F Patient is Alaska Native Yes No [X]
Review CDC Requirement
VFC providers must possess a working knowledge of all VFC eligibility criteria and use those criteria to screen children prior toadministering VFC vaccines In order to receive VFC vaccine a patient must be under the age of 19 and must be at least one of the following (1) Medicaid-eligible (2) Uninsured (ie child has no health insurance) (3) Underinsured (ie child has health insurancebut coverage does not cover any or certain vaccines ndash underinsured children may only receive VFC vaccines in FQHCRHC ordeputized VFC provider offices and only for vaccines not covered by insurance) and (4) American Indian or Alaska Native (AIAN)
Page 22 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 22
2 Eligibility Billing Practices
Question 22 Is the individualdepartment responsible for billing able to clearly explain how they bill for both the costof vaccine and the vaccine administration fee for each of the eligibility categories below
A Medicaid-eligible Cost of Vaccine Do not bill ndash provided by VFC Admin Fee Bill Medicaid
Yes No [X]
B Uninsured Cost of Vaccine Do not bill ndash provided by VFC Admin Fee If billing can bill patient
Yes No [X]
C Underinsured Cost of Vaccine Do not bill ndash provided by VFC through FQHCsRHCs or deputized providers only all other providers cannotprovide VFC vaccine to underinsured patients Admin Fee If billing can bill patient
Yes No [X]
D American IndianAlaska Native(AIAN)
Cost of Vaccine Do not bill - provided by VFC unless patient is fully insured and parent chooses to use insurance Admin Fee If patient is Medicaid-eligible bill Medicaid if billingand patient is uninsuredunderinsured can bill patient if parentchooses to use private insurance for cost of vaccine billpatientinsurance
Yes No [X]
E Do individuals responsible for billing have access to the results of eligibility screening toensure proper billing
Yes No [X]
Review CDC Requirement
VFC providers must adhere to proper billing practices for vaccine administration fees and clearly understand that VFC vaccine isprovided at no cost to both the VFC provider and eligible children At no time should billing occur for the cost of VFC vaccine Whenadministering VFC vaccine providers should never bill two different ldquopayersrdquo (ie patient Medicaid insurance) for the samevaccine administration fee amount For Medicaid-eligible children Medicaid should be billed for the vaccine administration fee Forall other VFC-eligible populations the patient may be billed within the stateterritory cap established by the Centers for Medicareand Medicaid (CMS) However patients cannot be turned away or reported to collections for inability to pay the administration fee
Goal of this question Determine if the staff correctly understand how to bill patients that are eligible for the MnVFC program Billing appropriately ensures that children can receive low cost immunizations and the site is in compliance with the VFC program
bull If there is any indication that sites could be billing insurance companies or parents for VFC vaccines this should be investigated further
bull Most sites in Minnesota will bill Medicaid with the SL modifier ndash which indicates this is a Medicaid claim
bull The main point is to ensure the site is not billing uninsured children for VFC vaccine and are not charging them more than $2122 per vaccine for the administration fee
bull Non-compliance is usually unintentional and may be resolved with some training In rare cases it could be a glimpse into a larger problem where a site is intentionally billing for financial gain
bull If you think the site is billing inappropriately it is the responsibility of the IPI advisor to report concerns to MDH staff for further assistance
Resources bull Immunization Billing Guidance for MnVFC (wwwhealthstatemnusdivsidepcimmunizemnvfc billingtipshtml) or Immunization Billing Guidance for MnVFC Replacement Method Sites (www healthstatemnusdivsidepcimmunizemnvfcreplacementbillingtipsrephtml)
bull Section 2 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 23
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 232 Eligibility Vaccine Administration Fee
Question 23 Document the actual vaccine administration fee charged to non-Medicaid VFC-eligible patients (confirmwith billing department)
Answers Fee $ [X] Follow-up is required if the provider charges more than the fee cap establishedby the Centers for Medicare and Medicaid (CMS) for your stateterritory ($2122)
Review CDC Requirement
The VFC providerrsquos vaccine administration fee for non-Medicaid VFC-eligible children must not exceed the stateterritory vaccineadministration fee cap established by the Centers for Medicare and Medicaid (CMS) For current fee caps refer to Medicaid Program Payments for Services Furnished by Certain Primary Care Physicians and Charges for Vaccine Administration Under theVaccines for Children Program Final Rule (httpwwwgpogovfdsyspkgFR-2012-11-06pdf2012-26507pdf)
Goal of this question Ensure that sites are not charging more than the federal allowable vaccine administration fee of $2122
bull The Centers for Medicaid and Medicare (CMS) establishes a maximum fee that sites can charge to non-Medicaid-eligible VFC patients in each stateterritory for vaccine administration Health Plans usually negotiate this fee with the site but Medicaid will not pay more
bull If a parent cannot pay the vaccine administration fee the patient cannot be turned away or reported to collections VFC-eligible children must be vaccinated regardless of their ability to pay
bull If the person with whom you are conducting the site visit does not know the exact fee charged to non-Medicaid VFC-eligible patients ask to speak to someone who can verify the exact amount
bull If they are charging more than $2122 for the administration fee ndash please contact MDH staff for help with addressing this situation
Resources bull Immunization Billing Guidance for MnVFC (wwwhealthstatemnusdivsidepcimmunizemnvfc billingtipshtml) or Immunization Billing Guidance for MnVFC Replacement Method Sites (www healthstatemnusdivsidepcimmunizemnvfcreplacementbillingtipsrephtml)
bull Section 2 of the MnVFC Policies and Procedures Manual
Page 24 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 3 Documentation Question 31
3 Documentation Eligibility Screening amp Documentation
Question 31 To answer the questions below the provider must clearly demonstrate the patient intake processReview a minimum of 10 records that contain an immunization visit within the last 6 ndash 12 months
Note to Reviewer Criteria for Record Selection 1) Record selection must be completely random and the provider must not know prior to the visit which
records will be reviewed 2) Patient must have been 0-19 years of age at the last visit (Note Records of 19-year-old patients may
allow you to see if VFC vaccines are being used beyond the allowable age) 3) Must review a mix of public and private-pay patients (if applicable)
A Does the provider have a process that ensures that patients are screened forVFC eligibility at each visit and that screening results are documented at each visit
Yes No [X] (If no skip question F)
B Does the providerrsquos process ensure that staff administering vaccine know which vaccine stock to select from prior to drawing the vaccine
Yes No [X]
C Number of records reviewed If fewer than 10 records are reviewed select the reason why Provider does not have 10 patient records with immunizations in last 12 months
D Do all records contain date of the immunization visit and patientrsquos date of birth Yes No [X]
E Do all records contain the patientrsquos specific eligibility status associated with thedate of the immunization
Yes No [X]
F Do any of the providerrsquos records contain any evidence that the patient received vaccine for which they were not eligible
Yes [X] No
Review CDC Requirement
VFC providers must screen for and document VFC eligibility at each immunization visit Documentation must include the date of the visit and the childrsquos specific eligibility category VFC providers must use screening results to ensure that only VFC-eligible children receive VFC vaccine and that administration fees are billed for as appropriate Eligibility status must be readily available to staff administering vaccine prior to selecting which vaccine stock to use
Goal of this question Ensure the site is screening for eligibility and documenting the eligibility category in the medical record
Review a minimum of 10 records from within the last 6-12 months where the patient received an immunization You must review a mix of public and private pay patients (if applicable)
Random selection is important If the staff have pre-selected records for review do not use and identify additional randomly selected records to review
Helpful information bull Discuss upgrading the electronic health record to make documentation of VFC eligibility screening a required field Documenting eligibility screening in the immunization field promotes better MIIC data
bull Q 31 B Sites using the replacement method of vaccine management only have one stock so you will answer ldquoYesrdquo to this question
Resources bull Patient Eligibility Screening Record on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfcformshtml)
bull Section 1 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 25
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 32
3 Documentation Vaccine Dose Documentation
Question 32 Review a minimum of 10 patient immunization records from the last six months (or 12 months ifnecessary) to assess compliance with documentation requirements set forth by Statute 42 US Code 300aa-25 (See note to reviewer below)
Note to Reviewer Criteria for Record Selection 1) Record selection must be completely random the Provider must not know prior to the visit which records
will be reviewed 2) Patient must have been 0-19 years of age at the last visit (Note Records of 19-year-old patients may allow
you to see if VFC vaccines are being used beyond the allowable age)
Records are Compliant if they Contain ALL the Below Elements
bull Address of clinic where vaccine was administered bull Publication date of VIS bull Name of vaccine administered bull Name of vaccine manufacturer bull Date vaccine was administered bull Lot number bull Date VIS was given bull Name and title of person who administered the
vaccine
A Number of records reviewed
B Number of records that contain ALL required documentation elements
If fewer than 10 records are reviewed select the reason why Provider does not have 10 patient records with immunizations in last 12 months
[X] Follow-up isrequired if one ormore records do not meet requirements
Goal of this question Assess whether the site is documenting all required information in each patientrsquos medical record for every vaccine dose administered in accordance with the National Childhood Vaccine Injury Act
Resources bull Section 6 of the MnVFC Policies and Procedures Manual bull National Vaccine Injury Compensation Program (wwwhrsagovvaccinecompensation)
Question 33
3 Documentation Record Retention
Question 33 Is the provider able to demonstrate (preferred) or clearly describe how they maintain historical VFCeligibility documentation for three years
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers are required to maintain all records related to the VFC program for a minimum of three years (or longer if requiredby state law) and upon request make these records available for review VFC records include but are not limited to VFC screening and eligibility documentation billing records medical records that verify receipt of vaccine vaccine ordering records and vaccinepurchase and accountability records
Goal of this question Make sure the site understands they are required to keep all MnVFC screening documentation for at least three years either electronically or on paper This information should be available to you at the time of the visit and future visits
Resource bull Section 7 of the MnVFC Policies and Procedures Manual
Page 26 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 34
3 Documentation Borrowing Documentation
Question 34 Discuss borrowing practices with the provider to answer the questions below
Note to Reviewer bull To be considered ldquofully documentedrdquo documentation for each borrowed dose must include thefollowing information
Vaccine type borrowed Date the dose was administered Stock used (VFC or private) Reason appropriate vaccine stock was not used Patient name and date of birth Date dose was returned to appropriate stock
A Did the provider state that they had borrowed any vaccines (whetherdocumented or not) since the last VFC Compliance Site Visit
Yes No (If no skip to question 36)
B Are there any doses for which there is no documentation (ie provider hasindicated that doses were borrowed but cannot verify how many or why)
All doses are documented Some doses are not documented [X] No doses are documented [X] (if nodoses documented skip toquestion 36)
C Were all borrowed doses fully documented (See Note to Reviewer above) Yes No [X]
D Were all borrowed VFC doses either replaced or an order submitted to replacethe doses Yes No [X]
Review CDC Requirement
VFC providers are expected to maintain an adequate inventory of vaccine for VFC and non-VFC-eligible patients It is theresponsibility of the VFC provider to appropriately schedule and place vaccine orders VFC providers must also rotate stock to ensure timely use of short-dated vaccines Borrowing of vaccine between private and public inventories must be a rare unplanned occurrence and cannot serve as a replacement system for a VFC providerrsquos privately purchased vaccine inventory All instances ofborrowing must be properly documented reported and replaced
Goal of this question Assess vaccine accountability by verifying that children are receiving vaccine from the appropriate stock
Borrowing is when a fully insured child receives a dose of MnVFC vaccine or a MnVFC-eligible child receives a dose of private vaccine This should be a rare unplanned occurrence The site must document any borrowing of vaccine between stocks ideally on the VFC Borrowing Report Form If they are not currently using the form review it with them and encourage them to post it close to their vaccines It does not need to be sent to MDH but should be kept for 3 years and filed with their MnVFC documents to be reviewed whenever they have a regular or unscheduled (unannounced) site visit
Helpful information bull Understand and report on staffrsquos verbal (ie anecdotal) accounts of borrowing obtained during the visit Often sites do not know that what they do is considered borrowing or they think borrowing is acceptable and documentation isnrsquot needed so long as those vaccines are eventually replaced
bull Since sites using the replacement method only have one stock of vaccine they very rarely borrow bull This question asks for future follow-up in 6 months Make a note on your calendar and ask them to send you a copy of their borrowing reports for the previous 6 months with documentation of doses borrowed and replaced We will remind you if we donrsquot hear from you at the 6 month time frame Complete the Follow-up Form and attach the borrowing form
Resources bull Vaccine Borrowing Report on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfc formshtml)
bull Section 10 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 27
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 353 Documentation Borrowing Reasons
Question 35 Based on your discussion with the provider and a review of borrowing reports document the dosesborrowed for each reason and answer the questions below
Note to Reviewer bull Short-dated vaccines are doses that are likely to expire before they can be used bull Exchanging short-dated vaccines should only occur in practices that have a small number of private
patients
A Reasons for Borrowing a VFC Dose (Enter the number of _____ Private vaccine shipment delay (order placed on time but delay in shippingreceipt)
vaccine doses borrowed for each
reason in the spaces
_____ Private vaccine not useable on arrival (vials broken temperature monitor out of range) _____ Ran out of private vaccine between orders (provider orders not placed on time) [X]
provided) _____ Short-dated private dose was exchanged with VFC stock _____ Accidental use of VFC dose for a private patient (human error) _____ Replacement of private dose with VFC when insurance plan did not cover vaccine _____ OtherDocumented dose did not include reason for borrowing [X]
(Explanation Required) Reasons for Borrowing a Private Dose _____ VFC vaccine shipment delay (order placed on time but delay in shippingreceipt) _____ VFC vaccine not useable on arrival (vials broken temperature monitor out of range) _____ Ran out of VFC stock between orders (provider orders not placed on time) [X] _____ Short-dated VFC vaccine dose was exchanged with private dose _____ Accidental use of a private dose for a VFC-eligible patient (human error) _____ OtherDocumented dose did not include reason for borrowing [X]
(Explanation Required)
B Enter date range for instances of borrowing reviewed in the borrowing report Note If ldquoDate of earliest instancerdquo is not available use the date of the last VFC Compliance Visit If ldquoDate of last instancerdquo is not available use the date of thecurrent VFC Compliance Visit
Date of earliest instance
Date of last instance
C Does borrowing appear to be a routine practice Note To determine whether borrowing is a routine practice assess frequency of and repeating reasons for borrowing Examples Frequent accidental use of incorrect stock exchanging short-dated vaccines or issues with ordering and shipment
Yes [X] No
Goal of this question Determine the reasons why the site is borrowing vaccine
If sites are using the Vaccine Borrowing Report review the reasons for borrowing to help document borrowed VFC andor private doses If they have not been documenting borrowing on this report (or any other form) estimate their borrowing practices If you do not know the date range for their borrowing use the last site visit date to the current visit date The use of ldquootherrdquo as the reported reason for borrowing should be rare if ever and would require explanation and follow up
Helpful information bull Look to see if they routinely maintain insufficient amounts or types of vaccine to support their public and private patients that leads to borrowing
bull Pay attention to borrowing cases documented as ldquoaccidentalrdquo Repetitive accidental borrowing may indicate an issue with ordering processes or insufficient staff training
bull Borrowing is not a place to document wasted or lost doses bull The time period of the borrowing may give you clues about the root cause Were the borrowed doses concentrated in a short period or spread out across several months or a year Are all vaccine types being borrowed or just one
bull If borrowing seems to be an issue discuss vaccine management ordering procedures
Resources bull Vaccine Borrowing Report on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfc formshtml)
bull Section 10 in the MnVFC Policies and Procedures Manual
Page 28 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 36
3 Documentation Vaccine Management Plan
Question 36 Physically review the providerrsquos Vaccine Management Plan to answer the question below
A Does the provider have a Vaccine Management Plan Yes No [X] (If no skip to question 37)
B Does the plan list the current Immunization Manager Vaccine Coordinator andback-up
Yes No [X]
C Does the plan address proper vaccine storage and handling practices Yes No [X]
D Does the plan specify vaccine receiving procedures Yes No [X]
E Does the plan contain procedures for what to do with vaccine in the event of an emergency
Yes No [X]
F Does the plan contain procedures for vaccine ordering Yes No [X]
G Does the plan address inventory control (example stock rotation) Yes No [X]
H Does the plan address how to handle vaccine wastage Yes No [X]
I Does the plan address staff training and documentation on vaccine managementstorage amp handling
Yes No [X]
J Does the plan contain a review date that falls within the last 12 months Yes No [X]
K Has the plan been signed by the individual responsible for its content Yes No [X]
Review CDC Requirement
VFC providers must develop maintain and implement a Vaccine Management Plan for routine and emergency vaccinemanagement The plan must contain the current Vaccine Coordinator and back-up proper storage and handling practicesshipping and receiving procedures emergency procedures procedures for vaccine ordering inventory control (eg stock rotation)how to handle vaccine wastage and staff trainingdocumentation on vaccine management storage and handling The plan must bereviewedupdated annually or more frequently if changes occur A ldquoreview daterdquo and signature are required on all plans in order tovalidate that they are current
Goal of this question Evaluate the sitersquos plan for vaccine management It is especially important that they have a plan for emergency management of their vaccine in the case of equipment failure or power outage Encourage all sites to read and sign the MnVFC Policies and Procedures Manual and complete the emergency plan or be able to show you a plan of their own
If the provider is not able to physically show you the plan at the time of the visit or if the recorded review date is not within the last 12 months you must mark that this requirement is unmet The Vaccine Management Plan is important in times of emergency and it should be easy to access by any staff member at any time Encourage them to post the plan and put a copy with the packing supplies
Helpful information bull Encourage the site to fill in the ldquoImmunization Managerrdquo and ldquoVaccine Coordinatorrdquo fields in the
MnVFC Policies and Procedures Manual for their own referencebull The emergency plan in the manual can be reviewed from last year and included in this yearrsquos manual (with an updated signature and date) if there have not been any changes
bull If information in the plan is outdated site staff will not be well equipped to safely manage vaccines in the event of a power-outage or other emergency situation
bull If their institutional policy is only reviewed and updated every 3-4 years (as many are) the staff may need to sign the MnVFC Polices and Procedure Manual to meet this requirement
Resource Routine Vaccine Management Plan and Emergency Vaccine Management Plan in the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 29
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 37
3 Documentation VIS amp VAERS
Question 37 Review the providerrsquos Vaccine Information Statements (VISs) and discuss providerrsquos VAERS process toanswer the questions below
A Does the provider have readily available up-to-date VISs for all ACIP-recommendedvaccines relevant to the populations it serves
Yes No [X]
B Does the provider make a VIS available for patientsparents before eachvaccination
Yes No [X]
C Does the provider know how and when to report clinically significant adverseevents using VAERS
Yes No [X]
Review CDC Requirement
VFC providers are required to distribute the current Vaccine Information Statements (VIS) each time a vaccine is administered and maintain records in accordance with the National Childhood Vaccine Injury Act (NCVIA) which includes reporting clinicallysignificant adverse events to the Vaccine Adverse Event Reporting System (VAERS) For a list of current VISs visit CDCrsquos Vaccine Information Statements (httpwwwcdcgovvaccineshcpvis) website
Gal of this question Ensure the site has the most current VISs and is giving them to each patientparent before administering the vaccine in compliance with the federal law Parents must be educated about the vaccine their child will receive and be aware of possible contraindications and side-effects in order to make well-informed decisions about their childrsquos health
Helpful information bull Ask to see the sitersquos VISs to determine if they have an active protocol for giving VISs to parents Review to make sure they are current Ask if they know where and how to report vaccine adverse events
Resources bull Section 3 in the MnVFC Policies and Procedures Manual bull CDC Vaccine Information Statements (wwwcdcgovvaccineshcpvisindexhtml) Site may sign up for email updates for the current list of VIS publication dates for the most up-to-date version
bull IAC Itrsquos Federal Law You must give your patients current Vaccine Information Statements (wwwimmunizeorgcatgdp2027pdf)
bull VAERS (httpsvaershhsgovindex)
Question 38
3 Documentation Anaphylaxis protocol
Question 38 Does the site have an anaphylaxis protocol which is clearly posted near the emergency kit
Answers (Choose one)
Yes No [X]
Review CDC Requirement
An anaphylaxis protocol must be clearly posted in the area where vaccines are administered
Goal of this question Make sure site is prepared for a severe allergic or anaphylactic reaction to a vaccine
Resources bull Section 11 in the MnVFC Policies and Procedures Manual bull IAC protocols Child and Teens (wwwimmunizeorgcatgdp3082apdf) and Adults (wwwimmunize orgcatgdp3082pdf)
Page 30 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
i
i i i - li i i i i i l
Section 4 Storage amp Handling Per Unit The goal of this section is to assess vaccine storage
2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet practices in each unit at the site MnVFC PIN ___________________
The 2017 MnVFC Storage amp Handling Per Unit Answer Sheet is a worksheet to document the answers to the questions in this section for each unit (combination or stand-alone) Fill in the answers to the questions in Section 4 on the answer sheet not in the questionnaire
The answer sheet has an abbreviated form of each question If you need further information on that question refer back to the full questionnaire Also if you find an area where the site is not meeting the requirements you will need to go back to that question on the 2017 MnVFC Site Visit Questionnaire to complete ldquoActions if Non- compliantrdquo section including the root cause analysis and follow-up sections If there is a problem in more than one unit make a note on the questionnaire which unit you are referring to in the Notes section
Important You must fully assess any unit that may be used to store VFC vaccines even if there are no VFC vaccines there on the day of the visit If there are no vaccines and the site is not documenting twice a day temperatures discuss the need to ensure the unit is maintaining stable temperatures by monitoring for one week before placing vaccines in the unit
Quest on number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
for the freezer and e co umn
Temperature Monitoring Dev refr gerator f the un
ce Quest ons Quest ons 4 3 4 7 must be answered separate y t s a combo Be sure to document responses n the appropr at
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
44D Data downloaded and reviewed routinely (eg weekly)
Yes No [O]
Yes No [O]
45A Certificate of Calibration Testing Yes No [X]
Yes No [X]
45B Date of calibration
45C Date certificate expires [X] Follow-up is required if expired [X] Follow-up is required if expired
45D Certificate contains all necessary items
Yes No [X]
Yes No [X]
46 Probe properly placed Yes No [X]
Yes No [X]
47A Two temperature readings per day
Yes No [X]
Yes No [X]
47B Time date and name (or initials) for each reading
Yes No [X]
Yes No [X]
47C Current temperature and minmax temperatures (if
Current ________deg Minimum ________deg Maximum _deg
Current ________deg Minimum ________deg Maximum _deg
Sections 5 and 6 contain questions about storage and handling site wide and inventory It is helpful to keep those questions in mind as you assess the individual storage units Think about dorm-style units expired vaccine vaccine supply room for vaccine stocking all the recommended vaccines and separation of stock if appropriate
NOTE The sections that follow require reviewers to validate responses by looking at vaccine storage units temperaturemonitoring equipment and the vaccine inventory inside a unit bull For section 4 use a separate Storage amp Handling Per Unit Answer Sheet for each unit to document the findings (combination
units using both sections can be documented on the same answer sheet) bull When an unmet requirement is identified return to this questionnaire to complete the ldquoActions if Non-compliantrdquo section for
that question bull After you complete one answer sheet for each unit return to the questionnaire to complete sections 5 and 6 using information
you gathered while assessing the units The questions in sections 5 and 6 (Storage amp Handling Site-Wide and Inventory) are notunit-specific but do require that the response be based on a thorough assessment of all the providersrsquo units
4 Storage amp Handling Per Unit
Description On the Storage amp Handling Per Unit Answer Sheet place a name that will allow you or someone else from your program to easily identify this unit in the event of follow-up We recommend using Brand + Location(example Samsung - Room 123) Save each Storage amp Handling Per Unit Answer Sheet with the Brand + Location in the file name
(example SamsungRoom123doc)
IPI Advisor Manual | February 2017 Page 31
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 41
4 Storage amp Handling Per Unit Storage Unit Build amp Use
Question 41 Below select the build and use of the vaccine storage unit you are assessing
Note to Reviewer Dorm-style units Do not add dorm-style units here Dorm-style units will be addressed in section 5 Units storing only private stock You must review these storage units even if they contain only private stockat the time of the visit because that vaccine could be administered to VFC patients
A What type of unit is this A Stand-alone B Combination
B Select use if stand-alone A Freezer B Refrigerator
Select use if combination A Use both sections to store vaccine B Use freezer section only to store vaccine C Use refrigerator section only to store vaccine
Goal of this question Identify the unit you are evaluating The description asks you to create a unique name for this unit so that you will be able to identify the same unit in future site visits Put this description on the top of the answer sheet (ie make and location)
Helpful information bull A stand-alone unit is either a refrigerator or a freezer It does not have both sections in the unit bull If there is a combination unit note if the site uses both the refrigerator and freezer or only one section of the unit to store vaccines CDC does not recommend the use of either section or the freezer section only of combination household units
bull If your site utilizes the separate stock method of vaccine management you must review storage units even if they contain only private stock at the time of the visit because there is a chance that those vaccines could be administered (borrowed) to VFC-eligible patients
Page 32 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 424 Storage amp Handling Per Unit CDC Recommended Storage Units
Question 42 Below document the grade of the vaccine storage unit you are assessing
Note to Reviewer Pharmaceutical Also called ldquopurpose-builtrdquo these units are designed by the manufacturer specifically tostore vaccines or other biological materials Commercial Although usually intended to store food and beverages commercial units are often larger and more powerful than the household units found in most homes Though these units are intended to meet thehigher demands of larger facilities these units are not specifically built for the storage of biologicalmaterials Household (non-commercialdomestic) These units are usually smaller than commercial units and areintended for use in small offices and in homes ndash typically for food storage However just like commercialunits they are not designed specifically for the storage of biological materials Such units are usually available in common home supply stores
Answers (Choose one)
Select grade A Pharmaceutical B CommercialHousehold
[O] CDC does not recommend the use of both sections or the freezer section only of combination commercialhousehold units
Review CDC Recommendation
CDC recommends the following vaccine storage unit types (in order of preference) pharmaceutical grade stand-alone orcombination units (preferred) householdcommercial stand-alone units householdcommercial combination units using therefrigerator section only
Goal of this question Assess the grade and type of each storage unit bull Pharmaceutical grade units may be stand-alone or combination units that are often metal may have glass in the door for viewing inside often have an external digital temperature display and are manufactured by medical companies
bull Commercial or household units often look like your kitchen appliance have vegetablemeat drawers in the unit and are manufactured by household appliance companies
bull Occasionally you might find a medical grade unit which is usually a commercialhousehold unit with a lock and 3-prong plug These are still considered household units because of their ability to maintain proper temperatures and air flow Studies show that household stand-alone units are better able to maintain consistent temperatures than their combination counterparts Combination household units used to store vaccine in both sections of the unit is no longer recommended and may be prohibited in the future Combination household storage units that are having difficulty maintaining a cold enough freezer temperature and a warm enough refrigerator temperature should be replaced or a separate stand-alone freezer should be purchased
For frozen vaccines the most cost effective solution is for the site to purchase a small stand-alone freezer The site may need time to budget for a stand-alone storage unit
Resources bull Replacing Combination Household Units Tip Sheet on IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml)
IPI Advisor Manual | February 2017 Page 33
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 434 Storage amp Handling Per Unit Temperature Monitoring Device in the Unit
Question 43 Determine whether there is a temperature monitoring device in this section of the storage unit andanswer the questions
A Is there a temperature monitoring device in this section of thestorage unit
Yes No [X] (If no skip to question 47)
B Who is responsible for supplying the temperature monitoring device in this section of the storage unit Provider
Review CDC Requirement
Certificates of calibration testing provide confidence that the temperature monitoring device is measuring temperaturesaccurately All units storing VFC vaccines must have a calibrated temperature monitoring device with a current and valid certificateof calibration testing All certificates must contain modeldevice name or number serial number date of calibration testing (report or issue date) and Instrument Passed testingInstrument in Tolerance (Recommended uncertainty = +-05ordm C (+-1ordm F))
Goal of this question Assess whether there is a temperature monitoring device in the unit If the unit is not being monitored at all call MDH at 651-201-5522 for guidance
Helpful information bull This question does not ask whether the temperature monitoring device is working or the characteristics of the device These issues will be addressed later in the questionnaire
bull For part B the provider is always responsible for supplying the temperature monitoring device Even if their thermometer or data logger was originally from MDH it is their responsibility to ensure it is functional and calibrated
Resources bull Section 8 in the MnVFC Policies and Procedures Manual
Page 34 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 444 Storage amp Handling Per Unit CDC Recommended Temperature Monitoring Device
Question 44 Assess the temperature monitoring device in this section of the storage unit to answer the questionsbelow
A Is the temperature monitoring device a continuous monitoring and recordingdevice (eg data logger)
Yes No [O] (Skip D)
B Does the temperature monitoring device have a probe in buffered material Yes No [O]
C Does the temperature monitoring device have a digital display that can beeasily read from the outside of this unit
Yes No [O]
D Is data downloaded and reviewed routinely Yes No [O]
Review CDC Recommendation
As of Jan 1 2018 all VFC providers must use continuous temperature monitoring devices (eg data loggers) to monitor vaccinesthat will be administered to VFC-eligible children Routine review and accessibility of temperature data is critical for determining whether vaccine has been properly stored and for assessing usability of vaccine that was involved in a temperature excursion Tomeet VFC Program requirements the device must also be equipped with bull A temperature probe bull An active temperature display that can be easily read from the outside of the unit bull The capacity for continuous monitoring and recording capabilities where the data can be routinely downloaded
The following are additional recommended features for these devices bull Alarm for out-of-range temperatures bull Current minimum and maximum temperatures display bull Low battery indicator bull Accuracy of +- 1degF (05degC) bull Memory storage of at least 4000 readings bull User programmable logging interval (or reading rate) recommended at a maximum time interval of every 30 minutes bull Use of a probe that best reflects the temperature of the vaccine (such as a buffered probe)
Goal of this question Assess the temperature monitoring device in the storage unit Note that these are all recommendations not requirements at this time
This is a great teaching opportunity for sites who do not currently have a continuous temperature monitoring device Beginning Jan 1 2018 all units that store MnVFC vaccine will be required to have a continuous temperature monitoring device (ie a data logger or a continuous temperature monitoring system) Unlike a minmax thermometer a continuous temperature monitoring device provides detailed information on all temperatures recorded at pre-set intervals For excursions it can provide information on when a temperature went out-of-range for how long and what the temperatures were This is essential information that vaccine manufacturers need to know to assess the viability of the vaccine following an excursion
Helpful information bull Sites are required to monitor and record temperatures twice daily however temperature excursions can easily occur in the 12 hours or longer between readings Continuous temperature monitoring can help manufacturers determine vaccine viability
bull Continue to encourage sites to document and evaluate minimum and maximum temperatures the storage unit reached since the last reading and respond appropriately to out-of-range temperatures
IPI Advisor Manual | February 2017 Page 35
The 2017 MnVFC Site Visit Paperwork Chapter 4
bull It is recommended that sites download and review data weekly Discuss with sites that reviewing temperature monitoring device data also includes responding appropriately if they identify out-of-range temps
bull There is sometimes confusion about the difference between a data logger and a continuous temperature monitoring system Here are some differences
Data Loggers Continuous Monitoring Systems Have an external display similar to thermometers May or may not have an external display Have a detachable probe Probe is usually attached to transmitter Need to be plugged into the computer or cradle to download information on a regular schedule
Wirelessly sends data to computer system
Create a file of data that needs to be saved on the computer
Data is stored within the system not a separate file
Doesnrsquot allow documentation of twice a day temperature checks in the file
May allow documentation of twice a day temperature checks within the system
More about the 2018 requirement for a continuous temperature monitoring device
Required Features bull The continuous temperature monitoring device must have Continuous monitoring and recording capabilities to track and record temperatures over time The capacity to routinely download temperature data to a computer (recommended at least weekly) or wirelessly transmit data Detachable probe in a bottle filled with a thermal buffer (eg bio-safe glycol) if the data logger needs to be detached in order to download data Active temperature display
Recommended Features bull MnVFC recommends continuous temperature monitoring devices with Alarm for out-of-range temperatures Accuracy within +-1degF (+- 05degC) Low battery indicator Display of current minimum and maximum temperatures Memory storage of at least 4000 readings User programmable logging intervals (eg the user can set how often the device records the temperature)
Note that these are all currently recommendations not requirements yet
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Page 36 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 45
Goal of this question Ensure the temperature monitoring device is properly calibrated The certificate of calibration testing means that the device has been tested and it is accurately measuring temperatures within established testing limits The certificate of calibration ensures that the device meets all the required components
Helpful information bull The provider is always responsible for having a current certificate of calibration (or copy) on-site
bull To be considered ldquovalidrdquo a certificate of calibration must contain these required elements Modeldevice name or number Serial number
4 Storage amp Handling Per Unit Certificate of Calibration Testing
Review CDC Requirement
Certificates of calibration testing provide confidence that the temperature monitoring device is measuring temperaturesaccurately All units storing VFC vaccines must have a calibrated temperature monitoring device with a current and valid certificateof calibration testing All certificates must contain modeldevice name or number serial number date of calibration testing (report or issue date) and Instrument Passed testingInstrument in Tolerance (Recommended uncertainty = +-05ordm C (+-1ordm F))
Question 45
Note to Reviewer
A
B
C
D
E
Review the certificate of calibration testing for the temperature monitoring device in this section of the storage unit and answer the questions below
bull How to determine certificate of calibration testing expiration date 1) Identify the certificate issuecalibration date 2) Apply the Immunization Program-required frequency for calibration testing Example If the
issuecalibration date is 12312013 and Immunization Program policy requires testing every twoyears the expiration date is 12312015
bull Certificates must include all of the below bull ModelDevice Name or Number bull Serial Number bull Date of Calibration Testing (Report or Issue Date) bull Instrument Passed testing (Instrument in Tolerance)
Is there a certificate of calibration testing for the temperature monitoring Yes device in this section of the storage unit No [X]
What is the date of calibration for the temperature monitoring device in this section of the storage unit
What is the certificatersquos date of expiration based on ImmunizationProgram policy (See note to reviewer to determine expiration date) [X] Follow-up is required if
certificate is expired
Does the certificate contain all the necessary items listed in the Note to Yes Reviewer No [X]
Who is responsible for supplying the current and valid certificate of Provider calibration for this temperature monitoring device
Date of calibration testing (report or issue date) Note If there is no expiration date the certificate expires 2 years from the date of calibration Whether the instrument passed or failed testing (or instrument in tolerancenot in tolerance)
bull Recommended element Documented uncertainty of +- 1degF [05degC]
If these elements are present the certificate is considered valid If the certificate contains information about the recommended element or the entity that issued the certificate that is helpful but not required
To determine if a certificate of calibration testing was issued by an appropriate entity check to see if the certificate indicates one or more of these items (this is the wording used to help sites evaluate if their calibration is accurate but is not required on the certificate itself to be considered valid)
bull Conforms to ISO 17025 bull Performed by an ILACMRA Signatory body accredited laboratory You can review this list of the ILAC MRA and Signatories (httpilacorgilac-mra-and-signatories)
bull Traceable to the standards maintained by NIST bull Meets specifications and testing requirements for the American Society for Testing and Materials (ASTM) Standard E2877 tolerance Class F (le 05 degC) or better
bull Includes reference to another acceptable accuracy validation method such as comparison to other traceable reference standards or tests at thermometric fixed points
Note CDC recommends that certifications be issued for the entire monitoring unit (detachable probe data logger etc) and not individual certificates for each component
IPI Advisor Manual | February 2017 Page 37
The 2017 MnVFC Site Visit Paperwork Chapter 4
For 45 E the provider is always responsible for supplying the current and valid certificate of calibration for a temperature monitoring device
bull Tip If the temperature monitoring device has a sticker on the back with the calibration date the site can usually call the company who calibrated the device and get a copy of the certificate if they donrsquot have one
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 46 4 Storage amp Handling Per Unit Probe Placement
Question 46 Is the probe properly placed in this section of the storage unit
Note to Reviewer ldquoProperlyrdquo means that the probe in a commercial or household unit is placed in a central area of the unitdirectly with the vaccines Probes should not be placed in the doors near or against the walls close to vents or on the floor of the unit The only allowable exemption related to this requirement is for providerswho have pharmaceutical storage units (built for vaccine storage) that have either (1) a built-intemperature monitoring device OR (2) a dedicated port for the probe that dictates the placement of theprobe
Answers (Choose one)
Yes No [X]
Review CDC Requirement
The probe must be placed in a central area of the section of the storage unit directly with the vaccines in order to properly measurevaccine temperature The probe should not be placed in the door near or against the walls close to vents or on the floor of theunit For pharmaceutical units with a built-in temperature monitoring device or a dedicated port for a probe that is not in thecenter of the section of the storage unit consult your Immunization Program for guidance on placement
Goal of this question Make sure the temperature monitoring device is in the best location to accurately measure the temperature of the vaccines stored in the unit
Helpful information bull The probe of the temperature monitoring device should be placed directly with the vaccines in the middle of the unit The ONLY allowable exception is for pharmaceutical storage units that have either a built-in thermometer or a dedicated port for the probe that indicates placement of the probe
bull Temperatures can vary within the unit especially household units bull Call MDH at 651-201-5522 if you have questions
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Guide (wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml)
Page 38 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 474 Storage amp Handling Per Unit Temperature Documentation
Question 47 Review the temperature documentation over the past three months for this section of the storage unit todetermine whether the provider has a process in place for properly documenting temperatures twice aday Answer the questions below
A Are there two temperature readings recorded for this section of the storage unit per day
Yes No [X]
B Is there a time date and name (or initials) recorded for each reading Yes No [X]
C What is the current temperature and minmax temperatures (if available) inthis section of the storage unit Use the reviewerrsquos thermometer if the providerrsquos temperature monitoringdevice does not have a current valid certificate of calibration testing or the probe is not properly placed in this section of the storage unit
Current Temperature Minimum Temperature Maximum Temperature Fahrenheit Celsius
D Based on your review of the providerrsquos recent temperature documentationincluding the current temperature is this section of the storage unitmaintaining appropriate temperatures
Yes No [X] Not enough information [X]
Review CDC Requirement
Vaccines must be stored under appropriate temperatures as described in the package inserts at all times Acceptable temperature ranges vary by vaccine type and the range is 36deg F and 46deg F (2deg C and 8deg C) and for frozen vaccines the range is -58deg F and +5deg F (shy50deg C and -15deg C) Exposure to temperatures outside of those included in the package inserts could affect vaccine viability andultimately could leave children unprotected against vaccine-preventable diseases In order to maintain awareness of storage unittemperatures and ensure that vaccines are being stored at appropriate temperatures at all times VFC providers are required to monitor and document temperatures for all vaccine storage units at least twice a day Temperature documentation must contain (1) at least two temperature readings per day (2) the time and date of each reading and (3) the name (or initials) of the personwho assessed and recorded the readings CDC also recommends that VFC providers record the minimum and maximumtemperatures of each unit once each workday (preferably in the morning)
Goal of this question Ensure the temperature is being monitored twice daily is within the required range and documented correctly Use your thermometer to check the temperature if the sitersquos temperature monitoring devicersquos probe is not properly placed or there is not a current certificate of calibration Place your thermometer in the unit at the beginning of the visit to allow sufficient time to reach an accurate temperature The purpose of using your thermometer is to ensure the vaccine is being stored at the proper temperature not to ldquovalidaterdquo their reading
Question 47 D is an assessment question based on information you have learned during your visit You might answer ldquonot enough informationrdquo if the unit is new and they donrsquot have at least three months of data or if the unit is only used as overflow and they are inconsistent with temperature monitoring Mark ldquoNordquo if you have reason to believe the storage unit is not maintaining temperatures properly
Helpful information bull All sites must document temperatures twice a day every day the site is open even if they have a data logger or continuous monitoring system
bull Sites can document the information electronically with some continuous monitoring systems as long as it can show what the current temp is the date time and initials of the person checking ndash this needs to be someone at the site ndash not checking remotely or centrally for a large site or system The site must be able to produce these records during their site visit Reviewing these files can be a challenge due to large volumes and lots of paper
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Temperature Logs on Managing Vaccine (wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml)
IPI Advisor Manual | February 2017 Page 39
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 484 Storage amp Handling Per Unit Temperature Excursions
Question 48 In the event that a temperature excursion(s) occurred in this unit within the last three months requestand review documentation of actions taken to determine whether the provider has a process for properlyaddressing excursions Answer the questions below
A Were vaccines in this unit exposed to out-of-range temperatures in the lastthree months (including today)
Yes No (If no skip to question 49)
B Did the provider quarantine and label vaccines as ldquoDo not userdquo Yes No [X]
C Did the provider place vaccine in a unit where it can be stored under properconditions if applicable
Yes No [X]
D Did the provider contact the Immunization Program to report theexcursion
Yes No [X]
E Was the manufacturer contacted for documentation supporting theusability of the vaccine
Yes No [X]
Review CDC Requirement
The provider must document all excursions and actions taken including the following (1) Quarantine and label vaccines as ldquoDO NOTUSErdquo (2) Place vaccines in a unit where they can be stored under proper conditions (3) Contact the Immunization Program to report an excursion and (4) Contact the vaccine manufacturer to obtain documentation supporting the usability of the vaccine
Goal of this question Address any out-of-range temperatures (temperature excursions) identified in reviewing the last three months of temperature logs or during the site visit If there were any out-of-range temperatures did the site respond appropriately to the situation This is a great opportunity to discuss what to do in the event of an excursion The Clinicians Storage and Handling Mishap Checklist is in the IPI Site Visit information folder and is a good review of the process
Helpful information bull Sites need to know that an excursion does not automatically mean that exposed vaccines are non-viable or unusable Exposed vaccines must be quarantined (marked ldquoDo Not Userdquo) and stored under proper conditions until they have received information from vaccine manufacturers regarding the viability of the vaccine
bull Sites must inform MDH when an excursion occurs
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Clinicians Storage and Handling Mishap Checklist (wwwhealthstatemnusdivsidepcimmunize ipivaxchklstpdf)
Page 40 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 49
Goal of this question Ensure proper placement of vaccines in the storage unit
Note These are all recommendations (best practices) not requirements
Helpful information bull Store vaccine in the middle of the compartment two to three inches away from the coils walls floor and cold air vent The temperature near the floor and walls of the unit differs from that in the middle of the compartment and the cold air vent can freeze refrigerated vaccines
4 Storage amp Handling Per Unit Vaccine Placement
Question 49 Look inside the unit to answer the questions below
A Are vaccines placed in the middle of the unit with space between vaccinesand the sideback of the unit to allow cold air to circulate
Yes No [O]
B Are vaccines stored in their original packages Yes No [O]
C Are there water bottles (for refrigerators) or frozen water bottles (forfreezers) in the unit
Yes No [O]
D Are vaccines store in the doors vegetable bins under or near cooling ventsor on the floor of the unit
Yes [O] No
E Is food being stored in the unit Yes [O] No
Review CDC Recommendation
Vaccines should be stored in their original manufacturer (or CDC centralized distributor) packaging They should be placed in the middle of the unit with space between the vaccines and the sideback of the unit to allow cold air to circulate Vaccines SHOULD NOT be stored in the doors vegetable bins or floor of the unit or under or near cooling vents and there should not be any food inthe unit Water bottles (for refrigerators) or frozen water bottles (for freezers) should be placed throughout each storage unit inorder to (1) stabilize or extend temperatures during a power outage and (2) to serve as physical blocks preventing the placementof vaccines in areas of the unit that are at higher risk for temperature excursions (such as in doors vegetable bins floor ornearunder cooling vents)
bull Vaccines should be kept in their original packaging to Protect them from light Help prevent medication errors by making labels easier to read Provide a moisture barrier that serves as insulation in case of an out-of-range temperature power outage door left open or mechanical failure Simplify managing vaccine inventory
bull Store water bottles in the doors on the floor and near the cold air vent in the refrigerator and frozen water bottles in the freezer to help maintain a stable temperature if there is a power failure and when the door is opened frequently Too many water bottles in the door can prevent the door from closing tightly Mark water bottles ldquoDo Not Drinkrdquo
bull Do not store vaccine in the door or drawers of the refrigerator or freezer Vegetable bins and crisper drawers should be removed from refrigerators or used to store other medical supplies or water bottles
bull If vaccine is stored in a household combination refrigeratorfreezer The top shelf should not be used for storing vaccine because the cold air vent blowing from the freezer will freeze vaccine located there If you must use the top shelf of this type of unit place water bottles underneath the cold air vent to prevent vaccine from being stored there It is recommended that only the refrigerator be used for vaccine storage and a separate stand-alone freezer be used to store frozen vaccine
bull Must not store food or beverages in the refrigerator or freezer because frequent opening of doors can lead to temperature variations that may affect vaccine viability There is also a risk of contaminating vaccines
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Guide (wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml) bull Vaccine Storage Tip Sheet on IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml)
IPI Advisor Manual | February 2017 Page 41
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 4104 Storage amp Handling Per Unit Disconnection from Power Source
Question 410 Ask the provider to demonstrate what measures are taken to ensure that vaccine storage units are notaccidentally physically disconnected from the power supply Which of the following describes the measure(s) taken on this unit
Note to Reviewer bull Large hospitals and healthcare systems may not have the ability to demonstrate labels on plugs or circuitbreakers In such cases verify that the practice has a comprehensive policy and standard operatingprocedures in place to prevent the vaccine storage unit from being physically disconnected from thepower supply
bull While back-up generators may ensure power to the overall facility this question ONLY addresses thevaccine storage unit being accidentally disconnected from the power source either through the plug orthe circuit breaker
Answers A ldquoDo not disconnectrdquo labels on the plug (Choose all that B ldquoWarningrdquo label on the circuit breaker box
apply) C Hard-wired (ie built-in) and has a ldquoDo not disconnectrdquo label on thecircuit breaker box D Hospital or large health care system with a comprehensive written policyand standard operating procedures detailing measures taken to preventvaccine storage units from being accidentally disconnected from the powersupply E No acceptable measures for preventing accidental disconnection frompower supply [X]
[X] The response is non-compliant if only A only B or E is selected
Review CDC Requirement
VFC providers must take steps to protect the power source for all vaccine storage equipment by means of having clear warninglabels on both the plug and the circuit breaker associated with all vaccine storage units Large hospitals and healthcare systems canmeet this requirement by demonstrating that they have comprehensive policies and standard operating procedures to preventvaccine storage units from being physically disconnected from the power supply
Goal of this question Decrease the chance that a vaccine storage unit will be accidently unplugged or power will be turned off while vaccine is in the unit This question addresses only what measures the site has taken to ensure the storage unit is not physically disconnected from its power source
If the site uses labels on the plugs and circuit breakers perform a visual inspection to assess whether the way the stickers are positioned make it clear and obvious to anyone that these units are not to be disconnected
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Do Not Unplug and Warning stickers are included in the folder or available to order on the For
Professionals Order Form (wwwhealthstatemnusdivsidepcimmunizeordermathtml)
Note Once you have completed the 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet for each unit return to the questionnaire to complete sections 5 and 6
Page 42 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
- -
Section 5 Storage amp Handling Site-Wide Question 51
5 Storage amp Handling Site Wide Discussion of Cost amp Quantity of Vaccine
Question 51 Have a discussion with the provider about the cost and quantity of VFC vaccines they are responsible for annually Address the points listed in the note to reviewer below
Note to Reviewer bull Vaccine Shipped (Required) Share the cost of VFC vaccines shipped to the provider in the last calendaryear to make sure the provider understands the contribution made by the VFC Program to their practiceFor new providers who do not have ldquocalendar yearrdquo data share either the actual cost of their currentinventory or use the cost of 10 VFC doses of each of the ACIP-recommended vaccines (approximately $7000) to help estimate their annual cost
bull Storage amp Handling (Required) Make sure the provider understands the cost of vaccines for which they are responsible when they make decisions about purchasing recommended vaccine storage and temperature monitoring equipment
Answer I have discussed with the provider the cost and quantity of vaccines ordered in the previous calendar year
Goal of this question Inform sites of the quantity and value of vaccines that they receive as part of the MnVFC program Providers often donrsquot realize the value of the vaccine in their unit This information is included on your clinic list and on the one page site-specific information
Helpful information bull This discussion must occur and the box on the questionnaire must be checked bull If there isnrsquot actual vaccine value information available tell the site that one vaccine order that includes a box of each of the ACIP recommended vaccines costs approximately $7000
bull MDH may not have specific information for individual sites if they receive vaccine from a central warehouse or pharmacy For those sites MDH will give you numbers for the whole system so you can discuss system wide data as appropriate If individual site information is also included it is usually just varicella-containing vaccines that must be shipped directly to the site
Question 52
5 Storage amp Handling Site Wide Dorm Style Units
Question 52 Determine whether the provider has any dorm-style units on site and answer the questions below
Note to Reviewer A dormitory-style refrigerator is a unit that has both refrigerator and freezer compartments behind a singleexterior door Dorm-style units also have an evaporator plate (cooling coil) which is usually located insidean icemaker compartment (freezer) within the refrigerator
A Does the provider have any dorm-style units that are used at any time tostore vaccines
Yes [X] No (Skip to question 53)
B Does the provider have sufficient space in existing compliant vaccinestorage units to store all vaccines without use of the dorm-style unit at any time
Yes No [X]
Review CDC Requirement
Dorm- and bar-style units are prohibited for vaccine storage Vaccines stored in dorm-style units are considered non-viable and must be returned to the centralized distributor CDC recommends the following vaccine storage unit types (in order of preference)pharmaceutical grade stand-alone or combination units (preferred) householdcommercial stand-alone unitshouseholdcommercial combination units using the refrigerator section only
Goal of this question Ensure no vaccine is stored in dorm-style units even for short periods of time Encourage them to label any units ldquoNo Vaccine Storage Allowedrdquo Vaccine stored in these units is considered non-viable If a site is using a dorm-style unit call the MnVFC program (651-201-5522)
Resource Section 8 in the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 43
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 535 Storage amp Handling Site Wide Storage Unit Space Availability
Question 53 Does the provider have sufficient room across storage units to store current stock as well as anyadditional stock acquired during peak season without overcrowding
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have sufficient storage space to accommodate vaccine stock at the busiest time of year without overcrowding
Goal of this question Ensure that sites have sufficient space in their units to maintain vaccines at the busiest time of year Overcrowding of vaccine limits air circulation and affects the unitrsquos ability to maintain stable temperatures
Helpful information bull Look for signs of overcrowding such as vaccines that are pushed up against the wall bins that are overflowing or storage units that are full during non-peak seasons
Discuss immediate actions if the unit is overcrowded Move some of their vaccines order less vaccine more frequently (once per month preferably) andor purchase another storage unit for overflow
Resource bull Section 8 MnVFC Policy and Procedure Manual
Page 44 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 545 Storage amp Handling Site Wide Expired Vaccines
Question 54 Look in each unit Are there expired vaccines in any of the vaccine storage units at this site
Answers (Choose one)
Yes [X] No
Review CDC Requirement
Vaccines should be rotated weekly and when a new shipment comes in so that longer-dated vaccines are stored behind shorter-dated vaccines If vaccines expire they can no longer be stored in the same storage unit with viable vaccines They must be placedin a container or bag clearly labeled ldquoDo not userdquo and separated from viable vaccines to prevent inadvertent use Expired vaccinemust be returned to the centralized distributor within six months of expiration
Goal of this question Ensure there is no expired vaccine in any storage unit
Helpful information bull Sites can prevent their stock from expiring by rotating vaccines every week andor when a new shipment arrives Longer-dated vaccines are stored towards the back of the unit and shorter-dated vaccines are up front
bull Pay attention to vaccines that expire within the next three months Consider transferring vaccine that will expire soon to another MnVFC-enrolled site that will use the vaccine preferably a site close by It is the transferring sitersquos responsibility to arrange the transfer of the vaccine Be sure to complete the MDH Vaccine Transfer Record form and send it to MDH If they are having difficulty finding a location to accept vaccine contact MDH
bull This is a great opportunity to educate sites about the MDH Nonviable Vaccine Form and the process for returning vaccine The VFC program does get some credit for taxes and fees on vaccine that is returned to the distribution center
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MDH Nonviable Vaccine Form and MDH Vaccine Transfer Record on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfcformshtml)
IPI Advisor Manual | February 2017 Page 45
The 2017 MnVFC Site Visit Paperwork Chapter 4
- -
-
Question 555 Storage amp Handling Site Wide Back up Thermometer
Question 55 Does the provider have a readily available back-up thermometer with a current and valid certificate ofcalibration testing
Note to Reviewer ldquoReadily availablerdquo means that the thermometer is available to perform twice-a-day monitoring for a unit asrequired CDC recommends that the back-up thermometer be maintained on site
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have a readily available back-up thermometer with a current and valid certificate of calibration testing Toprevent the certificates of calibration testing of the primary and back-up thermometers from expiring at the same time the date of calibration testing (or issue date) of the back-up thermometer should be different from the date of calibration testing (or issue date) of the primary thermometer As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meetsVFC program requirements
Goal of this question Ensure sites have one calibrated back-up thermometer onsite that is readily available in the event that the temperature monitoring device in unit fails transportation of vaccine is needed or there are other unexpected circumstances
Helpful information bull As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meets VFC Program requirements
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 56 5 Storage amp Handling Site Wide Preparation of Vaccine
Question 56 When does this provider prepare vaccine for administration to the patient
Note to Reviewer For mass vaccination clinics if one type of vaccine is offered providers may pre-draw up to 10 doses Ifusing pre-filled syringes pre-drawing also means activating the syringe by removing the needle guard orattaching a needle
Answers (Choose all that
apply)
Prepare dose immediately before administration Pre-draw doses for upcoming patients (in a regular clinicpractice) [O] Pre-draw up to 10 doses (in a mass-vaccination clinic) Pre-draw more than 10 doses (in a mass-vaccination clinic) [O] Other [O]
Review CDC Recommendation
CDC recommends preparing vaccines immediately prior to administration in order to assure viability of vaccine and prevent vaccinewastage Vaccines that are not administered immediately are at risk of exposure to temperatures outside of the required rangewhich can affect vaccine viability and ultimately can leave children unprotected against vaccine-preventable diseases
Goal of this question Discuss proper timing and preparation of vaccine(s) for administration These are recommendations not requirements
Helpful information bull Educate staff on the importance of preparing vaccine immediately before administration Pre-drawing of vaccines may lead to concerns related to vaccine viability potency sterility and wastage
Page 46 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 6 Inventory Question 61
6 Inventory Inventory Comparison
Question 61 Visually inspect storage units to determine if existing supply of vaccines proportionately mirrorspopulations served Choose the most accurate statement below
Note to Reviewer bull CDC recommends that providers maintain a four-week supply of inventory bull For this question do not take into account vaccine types that the provider does not order Here simply
make sure that overall the vaccines in the providerrsquos storage units are available in sufficient amounts toserve their patient population
Answers (Choose one)
The current vaccine inventory proportionately reflects the populations identified Only public stock is insufficient [X] Only private stock is insufficient [X] Both public and private stock are insufficient [X] Site uses the replacement method but does not appear to have enough vaccine for their population [X] Other [X]
Review CDC Requirement
VFC providers must order and stock routine vaccines in accordance with their patient population in order to prevent missedvaccination opportunities Having sufficient amounts of all stocks prevents the inadvertent use of VFC vaccines for non-VFC-eligiblepatients and vice versa
Goal of this question Assess whether the site is ordering appropriate quantities of vaccine for the population they serve at their site
Helpful information bull If the site sees 30 percent private-pay patients and 70 percent VFC the stock in their storage units should reflect that proportion If you donrsquot know you can ask the site about their population
bull This is meant to be a general assessment so in a big site if they have only a small amount of vaccine that may indicate an issue with vaccine management
bull CDC recommends smaller more frequent orders (ie monthly) rather than large orders to minimize the amount of vaccine loss if an incident occurs during shipment or in the storage unit Sites should not order more frequently than once a month
bull Sites using the replacement method will only have one stock but it should appear to be large enough for their population
bull Only assess the vaccine types that the site currently stocks in their unit We know there are sites that do not offer all ACIP-recommended vaccines for various reasons That issue will be addressed in question 62
IPI Advisor Manual | February 2017 Page 47
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 626 Inventory ACIP Recommended Vaccines
Question 62 Review providerrsquos current inventory to answer the questions below
A Does the provider offer all routine ACIP-recommendedvaccines for their patient population
Yes (Skip to question C) No [X] Offers all except varicella because direct ship ofvaccine is unavailable from manufacturer
B Which routine vaccines are NOT being offered DTaP Hepatitis A Hepatitis B HIB HPV Influenza Meningococcal
MMR Pneumococcal Polio Rotavirus TdapTd Varicella
C According to Immunization Program Policy does theprovider make accessible all non-routine ACIP-recommended vaccines for those VFC patients whomeet the criteria for receiving them
Yes (Skip to question 63) No [X]
D Which non-routine vaccines are NOT being offered Pneumococcal polysaccharide vaccine (PPSV23) Meningococcal Group B (MenB) Other
Review CDC Requirement
VFC providers agree to comply with immunization schedules dosages and contraindications that are established by the Advisory Committee on Immunization Practices (ACIP) for the vaccines identified and agreed upon in the Provider Agreement UNLESS bull In the VFC providers medical judgment and in accordance with accepted medical practice the VFC provider deems such
compliance to be medically inappropriate for the child bull The particular requirements contradict state law including laws pertaining to religious and other exemptions The VFC program entitles children to the following vaccines DTaP Hepatitis A Hepatitis B HIB HPV Influenza MeningococcalMMR Pneumococcal Polio Rotavirus TdapTd and Varicella VFC providers are also required to ensure that VFC-eligible children have access to non-routine vaccines as needed
Goal of this question Assess if the site is offering all the ACIP-recommended vaccines for the population they serve and these vaccines are in stock on the day of the visit It is important that every MnVFC-eligible child that comes to a providerrsquos office for an immunization is vaccinated
Helpful information bull The Advisory Committee on Immunization Practices (ACIP) is a group of medical and public health experts that develops recommendations on how to use vaccines to control diseases in the United States
bull Specialty providers are not required to offer all routine vaccines but should provide the vaccines appropriate for their population
bull If the site does not offer all routine ACIP-recommended vaccines appropriate for their population check the ldquoNordquo box in Part A then check the appropriate box(es) in Part B for any vaccines not offered Please contact MDH as this situation offers us the opportunity to provide education to the site
bull For non-routine vaccines they must either be in stock or the site must have an alternative protocol in the routine management plan that ensures these children have access when applicable
Resources bull IAC Diseases and Vaccines (wwwimmunizeorgvaccines) bull CDC Advisory Committee on Immunization Practices (ACIP) (wwwcdcgovvaccinesacipindexhtml)
Page 48 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 636 Inventory Separation of Stock
Question 63 Observe how the provider differentiates stock in each storage unit to answer the questions below
A Is it clear which vaccines belong to public stock andwhich belong to private stock
Yes No [X] Not applicable replacement site
B Is it clear which vaccines belong to VFC stock andwhich belong to UUAV stock
Yes No [X] Not applicable replacement site Not applicable not UUAV-enrolled site
Review CDC Requirement
In order to ensure that VFC vaccines are only administered to VFC-eligible children VFC providers that serve both VFC and non-VFCshyeligible children must maintain their vaccine inventories in such a way that they can clearly differentiate public stock from privatestock as well as VFC from other public stock
Goal of this question Assess whether the site can distinguish between MnVFC vaccine and private vaccine If they participate in the Uninsured and Underinsured Adult Vaccine (UUAV) program they should also be able to distinguish between MnVFC stock and UUAV stock Some sites use labels bins boxes etc to differentiate their stock If it is not clear how the site differentiates their stock discuss vaccine management with the staff For follow-up call MDH to discuss doing a follow-up site visit
Sites using the replacement method will not have separate stocksmdashthis is an approved alternative method for keeping track of vaccine
Resource bull Section 10 of the MnVFC Policy and Procedure Manual
IPI Advisor Manual | February 2017 Page 49
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
MnVFC Site Visit Storage and Handling Per Unit Answer Sheet 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet MnVFC PIN ___________________
Question number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
Temperature Monitoring Device Questions Questions 43 47 must be answered separately for the freezer and refrigerator if the unit is a combo Be sure to document responses in the appropriate column
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
All the questions on the Site Visit Storage amp Handling Per Unit Answer Sheet have been discussed previously in section 4 of this manual Use this sheet to record information about all the units at the site visit You will need one sheet for each unit If it is a combination unit (either pharmaceutical or household) you can record both sections on one sheet If they have stand-alone units use one sheet for each unit Do not enter the answers to the questions in section 4 of the questionnaire
If you need more information about any of the questions refer back to the main questionnairemdashthe complete question additional guidance including notes to the reviewer and the CDC requirements are there Also if the site is not meeting the requirement you will go back to the questionnaire to complete the ldquoActions if Non-compliantrdquo section including the root cause analysis and follow-up sections
When you have completed the assessment of all the storage units remember to go back to the questionnaire to complete sections 5 and 6
Page 50 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
ndash
ndash
MnVFC Provider Follow-up PlanThe goal of the Provider Follow-up Plan is to communicate with the site all of the VFC requirements any unmet requirements found during your site visit and the timeline for completing the required action The left hand column is a box to check for ldquoUnmetrdquo requirements
Helpful information bull The form can be used to review what the site is doing well and what they need to work on
bull For requirements that have specific documentation that needs to be sent to you use the notes section
2017 MnVFC Provider Follow-up Plan Site _______________________________________________ MnVFC PIN ____________ Date of Visit ___________
Thank you for participating in this MnVFC compliance site visit Please review this visit summary including follow-up actions and timelines for completion Unmet MnVFC requirements and recommendations have a checked box next to them The goal of this plan is to support you with successfully implementing the program and improving access to vaccines for VFC-eligible children
Unmet Question VFC Requirements Section 1 Changes to Key Staff
Q12 Change in the Medical Director Immunization Manager Vaccine Coordinator or back-upKey Staff must be communicated to the immunization program by emailing healthmnvfcstatemnus Changes Notes
Q12 Key staff must complete the annual training on VFC program requirements and print theAnnual Training certificate of completion Documentation Required Action
Staff that have not completed the MnVFC online training must complete it and send acopy of the certificate to the reviewer Training can be found on the MnVFC website (wwwhealthstatemnusvfc) Due date 1 month
Notes
Unmet Question VFC Requirements Section 2 Eligibility
Q21 Provider staff must possess a working knowledge of all VFC eligibility criteria and use thoseVFC Eligibility criteria to screen children prior to administering VFC vaccines
Categories Notes
bull This form provides documentation needed for follow-up actions when you send your thank you email
The second to last page of the Provider Follow-up Plan has a summary of the MnVFC program recommendations These are to remind the site about best practices they may want to improve upon even though they are not yet requirements of the program For example you could discuss the recommendation about storage units if they currently have a combination household unit and are using both sections
The last section is for your signature and the person you met with In most sites it will be the immunization manager or vaccine coordinator who signs the form unless the medical director attended the site visit You keep the original copy and the site will need to keep a copy for themselves
To be completed by the site visit reviewer
I acknowledge that a VFC site visit was performed on __________________ (visit date) The follow-up plan which includes a list of all current VFC program requirements and recommendations assessed during the visit and any required follow-up actions was provided at the end of the visit
Site visit reviewer
Phone
Reviewer Signature Date
To be completed by the provider
I acknowledge that our practice took part in the VFC site visit noted above I understand the findings of the visit and any required actions that must be taken by our office in order to meet VFC program requirements
Medical Director (or designee) Name Title
Medical Director (or designee) Signature Date
IPI Advisor Manual | February 2017 Page 51
The 2017 MnVFC Site Visit Paperwork Chapter 4
After the Site Visit Send a thank you email highlighting the unmet requirements documents you need from the site to resolve the issue(s) and the date you need them Make sure to include the link to the Site Visit Survey (httpssurveyvovicicomseashxs=56206EE334CE0B14)
Please refer to Chapter 3 for more information about future follow-up required after the visit including forms and documentation
Resource bull Sample Thank You letter on IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml)
Chapter 5
IPI Advisor Resource List MnVFC Program 651-201-5522
MnVFC wwwhealthstatemnusvfc
bull Separate Stock and Replacement Method Policies and Procedures Manuals bull Online trainings bull MnVFC Announcements sign up to receive them via email bull Ordering MDH vaccine bull MnVFC forms Screening forms Reporting forms Others MDH Nonviable Vaccine Form MDH Vaccine Transfer Record and Vaccine Borrowing Report
bull MnVFC promotional materials bull Immunization Billing Guidance for MnVFC and Immunization Billing Guidance for MnVFC Replacement Sites Immunization Practices Improvement Program (IPI) wwwhealthstatemnusdivsidepcimmunizeipi
bull IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml) bull IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml) IPI Resource Folder Contents (wwwhealthstatemnusdivsidepcimmunizeipiipifolderpdf)
Minnesota Immunization Information Connection (MIIC) wwwhealthstatemnusmiic
bull MIIC regions and regional coordinators
Clinical Practice MDH Immunization Program wwwhealthstatemnusimmunize
Got Your Shots News wwwhealthstatemnusdivsidepcnewslettersgys
MDH Immunization Information for Health Care Providers wwwhealthstatemnusdivsidepcimmunizehcp
bull Got Your Shots A Providers Guide to Immunization in Minnesota bull Vaccine protocols bull Forms for tracking patient immunizations bull Immunization schedules for Health Care Providers Immunization Action Coalition (IAC) wwwimmunizeorg
bull Ask the Experts bull VISs (Vaccine Information Statements and translations) bull Administration screening questions bull Medical management of vaccine reactions bull Order form for Californiarsquos Immunization Technique DVD Best Practices with Infants Children and Adults
Page 52 IPI Advisor Manual| February 2017
IPI Advisor Resource List Chapter 5
CDC ldquoPink Bookrdquo wwwcdcgovvaccinespubspinkbookindexhtml
CDC Advisory Committee on Immunization Practices (ACIP) wwwcdcgovvaccinesacip
CDC Vaccines and Immunizations wwwcdcgovvaccines
VAERS reporting httpvaershhsgovindex
Storage and Handling Got Your Shots Providers Guide ndash Managing Vaccine wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml
MnVFC Guide to Temperature Monitoring Devices wwwhealthstatemnusvfc
MDH Clinicianrsquos Vaccine Mishap Checklist wwwhealthstatemnusdivsidepcimmunizeipivaxchklstpdf
MDH Vaccine Storage Guide wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml
CDC Vaccine Storage and Handling Toolkit wwwcdcgovvaccinesrecsstoragetoolkit
You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Vaccine manufacturer phone numbers wwwcdcgovvaccinespubspinkbookdownloadsappendicesFcontact-info-manufactpdf
IAC Checklist for Safe Vaccine Handling and Storage wwwimmunizeorgcatgdp3035pdf
IAC Donrsquot Be Guilty of These Errors in Vaccine Storage and Handling wwwimmunizeorgcatgdp3036pdf
Additional Resources Print materials from MDH ndash order forms wwwhealthstatemnusdivsidepcimmunizeordermathtml
Vaccine Education Center ndash Childrenrsquos Hospital of Philadelphia wwwchopeduservicevaccine-education-centerhomehtml
California Department of Public Health ndash Interactive training on vaccine administration and storage and handling handout on transporting vaccine and how to package wwwezizorg
IPI Advisor Manual | February 2017 Page 53
IPI Advisor Resource List Chapter 5
CDC vaccine price list wwwcdcgovvaccinesprogramsvfcawardeesvaccine-managementprice-listindexhtml
Vaccine Information Statements (VIS) wwwcdcgovvaccineshcpvisindexhtml
CEU Opportunities CDC Immunization Education and Training wwwcdcgovvaccinesedindexhtml
Immunization You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Page 54 IPI Advisor Manual| February 2017
- Introduction
-
- Welcome to the Immunization Practice Improvement (IPI) Program
- Contact Information
-
- Chapter 1
- Requirements to Participate in the MnVFC Program
- Vaccines for Children Program
- Chapter 2
- Reimbursement for MnVFC Visits
- Types of Visits
- Your MnVFC Clinical CoordinatorPlanner
- New IPI Advisor Training Requirements
- Your Role as an IPI Advisor
- Reasons MDH Would Do All or Part of a Visit
- Chapter 3
- Future follow-up
- Conducting the Visit
- Preparing for the Visit
- Information for the Visit
- Site Visit Checklist
- Scheduling the Visit
- Chapter 4
- After the Site Visit
- MnVFC Provider Follow-up Plan
- MnVFC Site Visit Storage and Handling Per Unit Answer Sheet
- Section 6 Inventory
- Section 5 Storage amp Handling Site-Wide
- Section 4 Storage amp Handling Per Unit
- Section 3 Documentation
- Section 2 Eligibility
- Section 1 Provider Details
- The Site Visit Reviewer Legend
- MnVFC Site Visit Questionnaire
- Required Paperwork for Site Visits
- Chapter 5
-
IPI Advisor Manual | February 2017 Page 21
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 2 Eligibility Question 21
Goal of this Question Assess whether staff correctly understand which patients are eligible for the MnVFC program Screening ensures that eligible children receive the vaccines that they are entitled to receive under the MnVFC program and helps to prevent fraud or abuse of the program
Children 18 years and younger in these
categories can receive MnVFC vaccine at any enrolled site bull Uninsured bull Enrolled in a Minnesota Health Care Program (MHCP) Medical Assistance (MA) or MinnesotaCare bull American Indian or Alaskan Native
The following categories are considered underinsured and are only MnVFC-eligible at local public health (LPH) Federally Qualified Health Centers (FQHC) Rural Health Centers (RHC) Indian Health Services (IHS) and tribal health clinics
bull Has health insurance that does not cover one or more vaccines as can be the case with newly licensed vaccines that arenrsquot yet covered (MnVFC-eligible for non-covered vaccines only)
bull Has health insurance that caps vaccine coverage at a certain amount Once that amount is reached the child is MnVFC-eligible
Children with insurance that does not cover vaccines until a deductible has been met are considered to be fully insured and are not MnVFC-eligible
Helpful information bull Sites are not required to verify the patientrsquos response to the screening questions For example if a patient states they lost their insurance the site does not need to call the patientrsquos insurance company to confirm
If the site cannot correctly describe the eligibility categories provide educational materialsresources on MnVFC eligibility requirements
Resources bull Patient Eligibility Screening Record on MnVFC Forms (wwwhealthstatemnusdivsidepc immunizemnvfcformshtml)
bull Section 1 of the MnVFC Policies and Procedures Manual
2 Eligibility VFC Eligibility Categories
Question 21 Was the individual responsible for determining patient VFC eligibility able to explain all the factors(including age) that make a child eligible to receive VFC vaccines
A Patient is less than 19 years of age Yes No [X]
B Patient is Medicaid-eligible Yes No [X]
C Patient is uninsured Yes No [X]
D Patient is underinsured Yes No [X]
E Patient is American Indian Yes No [X]
F Patient is Alaska Native Yes No [X]
Review CDC Requirement
VFC providers must possess a working knowledge of all VFC eligibility criteria and use those criteria to screen children prior toadministering VFC vaccines In order to receive VFC vaccine a patient must be under the age of 19 and must be at least one of the following (1) Medicaid-eligible (2) Uninsured (ie child has no health insurance) (3) Underinsured (ie child has health insurancebut coverage does not cover any or certain vaccines ndash underinsured children may only receive VFC vaccines in FQHCRHC ordeputized VFC provider offices and only for vaccines not covered by insurance) and (4) American Indian or Alaska Native (AIAN)
Page 22 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 22
2 Eligibility Billing Practices
Question 22 Is the individualdepartment responsible for billing able to clearly explain how they bill for both the costof vaccine and the vaccine administration fee for each of the eligibility categories below
A Medicaid-eligible Cost of Vaccine Do not bill ndash provided by VFC Admin Fee Bill Medicaid
Yes No [X]
B Uninsured Cost of Vaccine Do not bill ndash provided by VFC Admin Fee If billing can bill patient
Yes No [X]
C Underinsured Cost of Vaccine Do not bill ndash provided by VFC through FQHCsRHCs or deputized providers only all other providers cannotprovide VFC vaccine to underinsured patients Admin Fee If billing can bill patient
Yes No [X]
D American IndianAlaska Native(AIAN)
Cost of Vaccine Do not bill - provided by VFC unless patient is fully insured and parent chooses to use insurance Admin Fee If patient is Medicaid-eligible bill Medicaid if billingand patient is uninsuredunderinsured can bill patient if parentchooses to use private insurance for cost of vaccine billpatientinsurance
Yes No [X]
E Do individuals responsible for billing have access to the results of eligibility screening toensure proper billing
Yes No [X]
Review CDC Requirement
VFC providers must adhere to proper billing practices for vaccine administration fees and clearly understand that VFC vaccine isprovided at no cost to both the VFC provider and eligible children At no time should billing occur for the cost of VFC vaccine Whenadministering VFC vaccine providers should never bill two different ldquopayersrdquo (ie patient Medicaid insurance) for the samevaccine administration fee amount For Medicaid-eligible children Medicaid should be billed for the vaccine administration fee Forall other VFC-eligible populations the patient may be billed within the stateterritory cap established by the Centers for Medicareand Medicaid (CMS) However patients cannot be turned away or reported to collections for inability to pay the administration fee
Goal of this question Determine if the staff correctly understand how to bill patients that are eligible for the MnVFC program Billing appropriately ensures that children can receive low cost immunizations and the site is in compliance with the VFC program
bull If there is any indication that sites could be billing insurance companies or parents for VFC vaccines this should be investigated further
bull Most sites in Minnesota will bill Medicaid with the SL modifier ndash which indicates this is a Medicaid claim
bull The main point is to ensure the site is not billing uninsured children for VFC vaccine and are not charging them more than $2122 per vaccine for the administration fee
bull Non-compliance is usually unintentional and may be resolved with some training In rare cases it could be a glimpse into a larger problem where a site is intentionally billing for financial gain
bull If you think the site is billing inappropriately it is the responsibility of the IPI advisor to report concerns to MDH staff for further assistance
Resources bull Immunization Billing Guidance for MnVFC (wwwhealthstatemnusdivsidepcimmunizemnvfc billingtipshtml) or Immunization Billing Guidance for MnVFC Replacement Method Sites (www healthstatemnusdivsidepcimmunizemnvfcreplacementbillingtipsrephtml)
bull Section 2 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 23
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 232 Eligibility Vaccine Administration Fee
Question 23 Document the actual vaccine administration fee charged to non-Medicaid VFC-eligible patients (confirmwith billing department)
Answers Fee $ [X] Follow-up is required if the provider charges more than the fee cap establishedby the Centers for Medicare and Medicaid (CMS) for your stateterritory ($2122)
Review CDC Requirement
The VFC providerrsquos vaccine administration fee for non-Medicaid VFC-eligible children must not exceed the stateterritory vaccineadministration fee cap established by the Centers for Medicare and Medicaid (CMS) For current fee caps refer to Medicaid Program Payments for Services Furnished by Certain Primary Care Physicians and Charges for Vaccine Administration Under theVaccines for Children Program Final Rule (httpwwwgpogovfdsyspkgFR-2012-11-06pdf2012-26507pdf)
Goal of this question Ensure that sites are not charging more than the federal allowable vaccine administration fee of $2122
bull The Centers for Medicaid and Medicare (CMS) establishes a maximum fee that sites can charge to non-Medicaid-eligible VFC patients in each stateterritory for vaccine administration Health Plans usually negotiate this fee with the site but Medicaid will not pay more
bull If a parent cannot pay the vaccine administration fee the patient cannot be turned away or reported to collections VFC-eligible children must be vaccinated regardless of their ability to pay
bull If the person with whom you are conducting the site visit does not know the exact fee charged to non-Medicaid VFC-eligible patients ask to speak to someone who can verify the exact amount
bull If they are charging more than $2122 for the administration fee ndash please contact MDH staff for help with addressing this situation
Resources bull Immunization Billing Guidance for MnVFC (wwwhealthstatemnusdivsidepcimmunizemnvfc billingtipshtml) or Immunization Billing Guidance for MnVFC Replacement Method Sites (www healthstatemnusdivsidepcimmunizemnvfcreplacementbillingtipsrephtml)
bull Section 2 of the MnVFC Policies and Procedures Manual
Page 24 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 3 Documentation Question 31
3 Documentation Eligibility Screening amp Documentation
Question 31 To answer the questions below the provider must clearly demonstrate the patient intake processReview a minimum of 10 records that contain an immunization visit within the last 6 ndash 12 months
Note to Reviewer Criteria for Record Selection 1) Record selection must be completely random and the provider must not know prior to the visit which
records will be reviewed 2) Patient must have been 0-19 years of age at the last visit (Note Records of 19-year-old patients may
allow you to see if VFC vaccines are being used beyond the allowable age) 3) Must review a mix of public and private-pay patients (if applicable)
A Does the provider have a process that ensures that patients are screened forVFC eligibility at each visit and that screening results are documented at each visit
Yes No [X] (If no skip question F)
B Does the providerrsquos process ensure that staff administering vaccine know which vaccine stock to select from prior to drawing the vaccine
Yes No [X]
C Number of records reviewed If fewer than 10 records are reviewed select the reason why Provider does not have 10 patient records with immunizations in last 12 months
D Do all records contain date of the immunization visit and patientrsquos date of birth Yes No [X]
E Do all records contain the patientrsquos specific eligibility status associated with thedate of the immunization
Yes No [X]
F Do any of the providerrsquos records contain any evidence that the patient received vaccine for which they were not eligible
Yes [X] No
Review CDC Requirement
VFC providers must screen for and document VFC eligibility at each immunization visit Documentation must include the date of the visit and the childrsquos specific eligibility category VFC providers must use screening results to ensure that only VFC-eligible children receive VFC vaccine and that administration fees are billed for as appropriate Eligibility status must be readily available to staff administering vaccine prior to selecting which vaccine stock to use
Goal of this question Ensure the site is screening for eligibility and documenting the eligibility category in the medical record
Review a minimum of 10 records from within the last 6-12 months where the patient received an immunization You must review a mix of public and private pay patients (if applicable)
Random selection is important If the staff have pre-selected records for review do not use and identify additional randomly selected records to review
Helpful information bull Discuss upgrading the electronic health record to make documentation of VFC eligibility screening a required field Documenting eligibility screening in the immunization field promotes better MIIC data
bull Q 31 B Sites using the replacement method of vaccine management only have one stock so you will answer ldquoYesrdquo to this question
Resources bull Patient Eligibility Screening Record on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfcformshtml)
bull Section 1 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 25
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 32
3 Documentation Vaccine Dose Documentation
Question 32 Review a minimum of 10 patient immunization records from the last six months (or 12 months ifnecessary) to assess compliance with documentation requirements set forth by Statute 42 US Code 300aa-25 (See note to reviewer below)
Note to Reviewer Criteria for Record Selection 1) Record selection must be completely random the Provider must not know prior to the visit which records
will be reviewed 2) Patient must have been 0-19 years of age at the last visit (Note Records of 19-year-old patients may allow
you to see if VFC vaccines are being used beyond the allowable age)
Records are Compliant if they Contain ALL the Below Elements
bull Address of clinic where vaccine was administered bull Publication date of VIS bull Name of vaccine administered bull Name of vaccine manufacturer bull Date vaccine was administered bull Lot number bull Date VIS was given bull Name and title of person who administered the
vaccine
A Number of records reviewed
B Number of records that contain ALL required documentation elements
If fewer than 10 records are reviewed select the reason why Provider does not have 10 patient records with immunizations in last 12 months
[X] Follow-up isrequired if one ormore records do not meet requirements
Goal of this question Assess whether the site is documenting all required information in each patientrsquos medical record for every vaccine dose administered in accordance with the National Childhood Vaccine Injury Act
Resources bull Section 6 of the MnVFC Policies and Procedures Manual bull National Vaccine Injury Compensation Program (wwwhrsagovvaccinecompensation)
Question 33
3 Documentation Record Retention
Question 33 Is the provider able to demonstrate (preferred) or clearly describe how they maintain historical VFCeligibility documentation for three years
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers are required to maintain all records related to the VFC program for a minimum of three years (or longer if requiredby state law) and upon request make these records available for review VFC records include but are not limited to VFC screening and eligibility documentation billing records medical records that verify receipt of vaccine vaccine ordering records and vaccinepurchase and accountability records
Goal of this question Make sure the site understands they are required to keep all MnVFC screening documentation for at least three years either electronically or on paper This information should be available to you at the time of the visit and future visits
Resource bull Section 7 of the MnVFC Policies and Procedures Manual
Page 26 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 34
3 Documentation Borrowing Documentation
Question 34 Discuss borrowing practices with the provider to answer the questions below
Note to Reviewer bull To be considered ldquofully documentedrdquo documentation for each borrowed dose must include thefollowing information
Vaccine type borrowed Date the dose was administered Stock used (VFC or private) Reason appropriate vaccine stock was not used Patient name and date of birth Date dose was returned to appropriate stock
A Did the provider state that they had borrowed any vaccines (whetherdocumented or not) since the last VFC Compliance Site Visit
Yes No (If no skip to question 36)
B Are there any doses for which there is no documentation (ie provider hasindicated that doses were borrowed but cannot verify how many or why)
All doses are documented Some doses are not documented [X] No doses are documented [X] (if nodoses documented skip toquestion 36)
C Were all borrowed doses fully documented (See Note to Reviewer above) Yes No [X]
D Were all borrowed VFC doses either replaced or an order submitted to replacethe doses Yes No [X]
Review CDC Requirement
VFC providers are expected to maintain an adequate inventory of vaccine for VFC and non-VFC-eligible patients It is theresponsibility of the VFC provider to appropriately schedule and place vaccine orders VFC providers must also rotate stock to ensure timely use of short-dated vaccines Borrowing of vaccine between private and public inventories must be a rare unplanned occurrence and cannot serve as a replacement system for a VFC providerrsquos privately purchased vaccine inventory All instances ofborrowing must be properly documented reported and replaced
Goal of this question Assess vaccine accountability by verifying that children are receiving vaccine from the appropriate stock
Borrowing is when a fully insured child receives a dose of MnVFC vaccine or a MnVFC-eligible child receives a dose of private vaccine This should be a rare unplanned occurrence The site must document any borrowing of vaccine between stocks ideally on the VFC Borrowing Report Form If they are not currently using the form review it with them and encourage them to post it close to their vaccines It does not need to be sent to MDH but should be kept for 3 years and filed with their MnVFC documents to be reviewed whenever they have a regular or unscheduled (unannounced) site visit
Helpful information bull Understand and report on staffrsquos verbal (ie anecdotal) accounts of borrowing obtained during the visit Often sites do not know that what they do is considered borrowing or they think borrowing is acceptable and documentation isnrsquot needed so long as those vaccines are eventually replaced
bull Since sites using the replacement method only have one stock of vaccine they very rarely borrow bull This question asks for future follow-up in 6 months Make a note on your calendar and ask them to send you a copy of their borrowing reports for the previous 6 months with documentation of doses borrowed and replaced We will remind you if we donrsquot hear from you at the 6 month time frame Complete the Follow-up Form and attach the borrowing form
Resources bull Vaccine Borrowing Report on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfc formshtml)
bull Section 10 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 27
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 353 Documentation Borrowing Reasons
Question 35 Based on your discussion with the provider and a review of borrowing reports document the dosesborrowed for each reason and answer the questions below
Note to Reviewer bull Short-dated vaccines are doses that are likely to expire before they can be used bull Exchanging short-dated vaccines should only occur in practices that have a small number of private
patients
A Reasons for Borrowing a VFC Dose (Enter the number of _____ Private vaccine shipment delay (order placed on time but delay in shippingreceipt)
vaccine doses borrowed for each
reason in the spaces
_____ Private vaccine not useable on arrival (vials broken temperature monitor out of range) _____ Ran out of private vaccine between orders (provider orders not placed on time) [X]
provided) _____ Short-dated private dose was exchanged with VFC stock _____ Accidental use of VFC dose for a private patient (human error) _____ Replacement of private dose with VFC when insurance plan did not cover vaccine _____ OtherDocumented dose did not include reason for borrowing [X]
(Explanation Required) Reasons for Borrowing a Private Dose _____ VFC vaccine shipment delay (order placed on time but delay in shippingreceipt) _____ VFC vaccine not useable on arrival (vials broken temperature monitor out of range) _____ Ran out of VFC stock between orders (provider orders not placed on time) [X] _____ Short-dated VFC vaccine dose was exchanged with private dose _____ Accidental use of a private dose for a VFC-eligible patient (human error) _____ OtherDocumented dose did not include reason for borrowing [X]
(Explanation Required)
B Enter date range for instances of borrowing reviewed in the borrowing report Note If ldquoDate of earliest instancerdquo is not available use the date of the last VFC Compliance Visit If ldquoDate of last instancerdquo is not available use the date of thecurrent VFC Compliance Visit
Date of earliest instance
Date of last instance
C Does borrowing appear to be a routine practice Note To determine whether borrowing is a routine practice assess frequency of and repeating reasons for borrowing Examples Frequent accidental use of incorrect stock exchanging short-dated vaccines or issues with ordering and shipment
Yes [X] No
Goal of this question Determine the reasons why the site is borrowing vaccine
If sites are using the Vaccine Borrowing Report review the reasons for borrowing to help document borrowed VFC andor private doses If they have not been documenting borrowing on this report (or any other form) estimate their borrowing practices If you do not know the date range for their borrowing use the last site visit date to the current visit date The use of ldquootherrdquo as the reported reason for borrowing should be rare if ever and would require explanation and follow up
Helpful information bull Look to see if they routinely maintain insufficient amounts or types of vaccine to support their public and private patients that leads to borrowing
bull Pay attention to borrowing cases documented as ldquoaccidentalrdquo Repetitive accidental borrowing may indicate an issue with ordering processes or insufficient staff training
bull Borrowing is not a place to document wasted or lost doses bull The time period of the borrowing may give you clues about the root cause Were the borrowed doses concentrated in a short period or spread out across several months or a year Are all vaccine types being borrowed or just one
bull If borrowing seems to be an issue discuss vaccine management ordering procedures
Resources bull Vaccine Borrowing Report on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfc formshtml)
bull Section 10 in the MnVFC Policies and Procedures Manual
Page 28 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 36
3 Documentation Vaccine Management Plan
Question 36 Physically review the providerrsquos Vaccine Management Plan to answer the question below
A Does the provider have a Vaccine Management Plan Yes No [X] (If no skip to question 37)
B Does the plan list the current Immunization Manager Vaccine Coordinator andback-up
Yes No [X]
C Does the plan address proper vaccine storage and handling practices Yes No [X]
D Does the plan specify vaccine receiving procedures Yes No [X]
E Does the plan contain procedures for what to do with vaccine in the event of an emergency
Yes No [X]
F Does the plan contain procedures for vaccine ordering Yes No [X]
G Does the plan address inventory control (example stock rotation) Yes No [X]
H Does the plan address how to handle vaccine wastage Yes No [X]
I Does the plan address staff training and documentation on vaccine managementstorage amp handling
Yes No [X]
J Does the plan contain a review date that falls within the last 12 months Yes No [X]
K Has the plan been signed by the individual responsible for its content Yes No [X]
Review CDC Requirement
VFC providers must develop maintain and implement a Vaccine Management Plan for routine and emergency vaccinemanagement The plan must contain the current Vaccine Coordinator and back-up proper storage and handling practicesshipping and receiving procedures emergency procedures procedures for vaccine ordering inventory control (eg stock rotation)how to handle vaccine wastage and staff trainingdocumentation on vaccine management storage and handling The plan must bereviewedupdated annually or more frequently if changes occur A ldquoreview daterdquo and signature are required on all plans in order tovalidate that they are current
Goal of this question Evaluate the sitersquos plan for vaccine management It is especially important that they have a plan for emergency management of their vaccine in the case of equipment failure or power outage Encourage all sites to read and sign the MnVFC Policies and Procedures Manual and complete the emergency plan or be able to show you a plan of their own
If the provider is not able to physically show you the plan at the time of the visit or if the recorded review date is not within the last 12 months you must mark that this requirement is unmet The Vaccine Management Plan is important in times of emergency and it should be easy to access by any staff member at any time Encourage them to post the plan and put a copy with the packing supplies
Helpful information bull Encourage the site to fill in the ldquoImmunization Managerrdquo and ldquoVaccine Coordinatorrdquo fields in the
MnVFC Policies and Procedures Manual for their own referencebull The emergency plan in the manual can be reviewed from last year and included in this yearrsquos manual (with an updated signature and date) if there have not been any changes
bull If information in the plan is outdated site staff will not be well equipped to safely manage vaccines in the event of a power-outage or other emergency situation
bull If their institutional policy is only reviewed and updated every 3-4 years (as many are) the staff may need to sign the MnVFC Polices and Procedure Manual to meet this requirement
Resource Routine Vaccine Management Plan and Emergency Vaccine Management Plan in the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 29
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 37
3 Documentation VIS amp VAERS
Question 37 Review the providerrsquos Vaccine Information Statements (VISs) and discuss providerrsquos VAERS process toanswer the questions below
A Does the provider have readily available up-to-date VISs for all ACIP-recommendedvaccines relevant to the populations it serves
Yes No [X]
B Does the provider make a VIS available for patientsparents before eachvaccination
Yes No [X]
C Does the provider know how and when to report clinically significant adverseevents using VAERS
Yes No [X]
Review CDC Requirement
VFC providers are required to distribute the current Vaccine Information Statements (VIS) each time a vaccine is administered and maintain records in accordance with the National Childhood Vaccine Injury Act (NCVIA) which includes reporting clinicallysignificant adverse events to the Vaccine Adverse Event Reporting System (VAERS) For a list of current VISs visit CDCrsquos Vaccine Information Statements (httpwwwcdcgovvaccineshcpvis) website
Gal of this question Ensure the site has the most current VISs and is giving them to each patientparent before administering the vaccine in compliance with the federal law Parents must be educated about the vaccine their child will receive and be aware of possible contraindications and side-effects in order to make well-informed decisions about their childrsquos health
Helpful information bull Ask to see the sitersquos VISs to determine if they have an active protocol for giving VISs to parents Review to make sure they are current Ask if they know where and how to report vaccine adverse events
Resources bull Section 3 in the MnVFC Policies and Procedures Manual bull CDC Vaccine Information Statements (wwwcdcgovvaccineshcpvisindexhtml) Site may sign up for email updates for the current list of VIS publication dates for the most up-to-date version
bull IAC Itrsquos Federal Law You must give your patients current Vaccine Information Statements (wwwimmunizeorgcatgdp2027pdf)
bull VAERS (httpsvaershhsgovindex)
Question 38
3 Documentation Anaphylaxis protocol
Question 38 Does the site have an anaphylaxis protocol which is clearly posted near the emergency kit
Answers (Choose one)
Yes No [X]
Review CDC Requirement
An anaphylaxis protocol must be clearly posted in the area where vaccines are administered
Goal of this question Make sure site is prepared for a severe allergic or anaphylactic reaction to a vaccine
Resources bull Section 11 in the MnVFC Policies and Procedures Manual bull IAC protocols Child and Teens (wwwimmunizeorgcatgdp3082apdf) and Adults (wwwimmunize orgcatgdp3082pdf)
Page 30 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
i
i i i - li i i i i i l
Section 4 Storage amp Handling Per Unit The goal of this section is to assess vaccine storage
2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet practices in each unit at the site MnVFC PIN ___________________
The 2017 MnVFC Storage amp Handling Per Unit Answer Sheet is a worksheet to document the answers to the questions in this section for each unit (combination or stand-alone) Fill in the answers to the questions in Section 4 on the answer sheet not in the questionnaire
The answer sheet has an abbreviated form of each question If you need further information on that question refer back to the full questionnaire Also if you find an area where the site is not meeting the requirements you will need to go back to that question on the 2017 MnVFC Site Visit Questionnaire to complete ldquoActions if Non- compliantrdquo section including the root cause analysis and follow-up sections If there is a problem in more than one unit make a note on the questionnaire which unit you are referring to in the Notes section
Important You must fully assess any unit that may be used to store VFC vaccines even if there are no VFC vaccines there on the day of the visit If there are no vaccines and the site is not documenting twice a day temperatures discuss the need to ensure the unit is maintaining stable temperatures by monitoring for one week before placing vaccines in the unit
Quest on number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
for the freezer and e co umn
Temperature Monitoring Dev refr gerator f the un
ce Quest ons Quest ons 4 3 4 7 must be answered separate y t s a combo Be sure to document responses n the appropr at
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
44D Data downloaded and reviewed routinely (eg weekly)
Yes No [O]
Yes No [O]
45A Certificate of Calibration Testing Yes No [X]
Yes No [X]
45B Date of calibration
45C Date certificate expires [X] Follow-up is required if expired [X] Follow-up is required if expired
45D Certificate contains all necessary items
Yes No [X]
Yes No [X]
46 Probe properly placed Yes No [X]
Yes No [X]
47A Two temperature readings per day
Yes No [X]
Yes No [X]
47B Time date and name (or initials) for each reading
Yes No [X]
Yes No [X]
47C Current temperature and minmax temperatures (if
Current ________deg Minimum ________deg Maximum _deg
Current ________deg Minimum ________deg Maximum _deg
Sections 5 and 6 contain questions about storage and handling site wide and inventory It is helpful to keep those questions in mind as you assess the individual storage units Think about dorm-style units expired vaccine vaccine supply room for vaccine stocking all the recommended vaccines and separation of stock if appropriate
NOTE The sections that follow require reviewers to validate responses by looking at vaccine storage units temperaturemonitoring equipment and the vaccine inventory inside a unit bull For section 4 use a separate Storage amp Handling Per Unit Answer Sheet for each unit to document the findings (combination
units using both sections can be documented on the same answer sheet) bull When an unmet requirement is identified return to this questionnaire to complete the ldquoActions if Non-compliantrdquo section for
that question bull After you complete one answer sheet for each unit return to the questionnaire to complete sections 5 and 6 using information
you gathered while assessing the units The questions in sections 5 and 6 (Storage amp Handling Site-Wide and Inventory) are notunit-specific but do require that the response be based on a thorough assessment of all the providersrsquo units
4 Storage amp Handling Per Unit
Description On the Storage amp Handling Per Unit Answer Sheet place a name that will allow you or someone else from your program to easily identify this unit in the event of follow-up We recommend using Brand + Location(example Samsung - Room 123) Save each Storage amp Handling Per Unit Answer Sheet with the Brand + Location in the file name
(example SamsungRoom123doc)
IPI Advisor Manual | February 2017 Page 31
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 41
4 Storage amp Handling Per Unit Storage Unit Build amp Use
Question 41 Below select the build and use of the vaccine storage unit you are assessing
Note to Reviewer Dorm-style units Do not add dorm-style units here Dorm-style units will be addressed in section 5 Units storing only private stock You must review these storage units even if they contain only private stockat the time of the visit because that vaccine could be administered to VFC patients
A What type of unit is this A Stand-alone B Combination
B Select use if stand-alone A Freezer B Refrigerator
Select use if combination A Use both sections to store vaccine B Use freezer section only to store vaccine C Use refrigerator section only to store vaccine
Goal of this question Identify the unit you are evaluating The description asks you to create a unique name for this unit so that you will be able to identify the same unit in future site visits Put this description on the top of the answer sheet (ie make and location)
Helpful information bull A stand-alone unit is either a refrigerator or a freezer It does not have both sections in the unit bull If there is a combination unit note if the site uses both the refrigerator and freezer or only one section of the unit to store vaccines CDC does not recommend the use of either section or the freezer section only of combination household units
bull If your site utilizes the separate stock method of vaccine management you must review storage units even if they contain only private stock at the time of the visit because there is a chance that those vaccines could be administered (borrowed) to VFC-eligible patients
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The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 424 Storage amp Handling Per Unit CDC Recommended Storage Units
Question 42 Below document the grade of the vaccine storage unit you are assessing
Note to Reviewer Pharmaceutical Also called ldquopurpose-builtrdquo these units are designed by the manufacturer specifically tostore vaccines or other biological materials Commercial Although usually intended to store food and beverages commercial units are often larger and more powerful than the household units found in most homes Though these units are intended to meet thehigher demands of larger facilities these units are not specifically built for the storage of biologicalmaterials Household (non-commercialdomestic) These units are usually smaller than commercial units and areintended for use in small offices and in homes ndash typically for food storage However just like commercialunits they are not designed specifically for the storage of biological materials Such units are usually available in common home supply stores
Answers (Choose one)
Select grade A Pharmaceutical B CommercialHousehold
[O] CDC does not recommend the use of both sections or the freezer section only of combination commercialhousehold units
Review CDC Recommendation
CDC recommends the following vaccine storage unit types (in order of preference) pharmaceutical grade stand-alone orcombination units (preferred) householdcommercial stand-alone units householdcommercial combination units using therefrigerator section only
Goal of this question Assess the grade and type of each storage unit bull Pharmaceutical grade units may be stand-alone or combination units that are often metal may have glass in the door for viewing inside often have an external digital temperature display and are manufactured by medical companies
bull Commercial or household units often look like your kitchen appliance have vegetablemeat drawers in the unit and are manufactured by household appliance companies
bull Occasionally you might find a medical grade unit which is usually a commercialhousehold unit with a lock and 3-prong plug These are still considered household units because of their ability to maintain proper temperatures and air flow Studies show that household stand-alone units are better able to maintain consistent temperatures than their combination counterparts Combination household units used to store vaccine in both sections of the unit is no longer recommended and may be prohibited in the future Combination household storage units that are having difficulty maintaining a cold enough freezer temperature and a warm enough refrigerator temperature should be replaced or a separate stand-alone freezer should be purchased
For frozen vaccines the most cost effective solution is for the site to purchase a small stand-alone freezer The site may need time to budget for a stand-alone storage unit
Resources bull Replacing Combination Household Units Tip Sheet on IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml)
IPI Advisor Manual | February 2017 Page 33
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 434 Storage amp Handling Per Unit Temperature Monitoring Device in the Unit
Question 43 Determine whether there is a temperature monitoring device in this section of the storage unit andanswer the questions
A Is there a temperature monitoring device in this section of thestorage unit
Yes No [X] (If no skip to question 47)
B Who is responsible for supplying the temperature monitoring device in this section of the storage unit Provider
Review CDC Requirement
Certificates of calibration testing provide confidence that the temperature monitoring device is measuring temperaturesaccurately All units storing VFC vaccines must have a calibrated temperature monitoring device with a current and valid certificateof calibration testing All certificates must contain modeldevice name or number serial number date of calibration testing (report or issue date) and Instrument Passed testingInstrument in Tolerance (Recommended uncertainty = +-05ordm C (+-1ordm F))
Goal of this question Assess whether there is a temperature monitoring device in the unit If the unit is not being monitored at all call MDH at 651-201-5522 for guidance
Helpful information bull This question does not ask whether the temperature monitoring device is working or the characteristics of the device These issues will be addressed later in the questionnaire
bull For part B the provider is always responsible for supplying the temperature monitoring device Even if their thermometer or data logger was originally from MDH it is their responsibility to ensure it is functional and calibrated
Resources bull Section 8 in the MnVFC Policies and Procedures Manual
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-
Question 444 Storage amp Handling Per Unit CDC Recommended Temperature Monitoring Device
Question 44 Assess the temperature monitoring device in this section of the storage unit to answer the questionsbelow
A Is the temperature monitoring device a continuous monitoring and recordingdevice (eg data logger)
Yes No [O] (Skip D)
B Does the temperature monitoring device have a probe in buffered material Yes No [O]
C Does the temperature monitoring device have a digital display that can beeasily read from the outside of this unit
Yes No [O]
D Is data downloaded and reviewed routinely Yes No [O]
Review CDC Recommendation
As of Jan 1 2018 all VFC providers must use continuous temperature monitoring devices (eg data loggers) to monitor vaccinesthat will be administered to VFC-eligible children Routine review and accessibility of temperature data is critical for determining whether vaccine has been properly stored and for assessing usability of vaccine that was involved in a temperature excursion Tomeet VFC Program requirements the device must also be equipped with bull A temperature probe bull An active temperature display that can be easily read from the outside of the unit bull The capacity for continuous monitoring and recording capabilities where the data can be routinely downloaded
The following are additional recommended features for these devices bull Alarm for out-of-range temperatures bull Current minimum and maximum temperatures display bull Low battery indicator bull Accuracy of +- 1degF (05degC) bull Memory storage of at least 4000 readings bull User programmable logging interval (or reading rate) recommended at a maximum time interval of every 30 minutes bull Use of a probe that best reflects the temperature of the vaccine (such as a buffered probe)
Goal of this question Assess the temperature monitoring device in the storage unit Note that these are all recommendations not requirements at this time
This is a great teaching opportunity for sites who do not currently have a continuous temperature monitoring device Beginning Jan 1 2018 all units that store MnVFC vaccine will be required to have a continuous temperature monitoring device (ie a data logger or a continuous temperature monitoring system) Unlike a minmax thermometer a continuous temperature monitoring device provides detailed information on all temperatures recorded at pre-set intervals For excursions it can provide information on when a temperature went out-of-range for how long and what the temperatures were This is essential information that vaccine manufacturers need to know to assess the viability of the vaccine following an excursion
Helpful information bull Sites are required to monitor and record temperatures twice daily however temperature excursions can easily occur in the 12 hours or longer between readings Continuous temperature monitoring can help manufacturers determine vaccine viability
bull Continue to encourage sites to document and evaluate minimum and maximum temperatures the storage unit reached since the last reading and respond appropriately to out-of-range temperatures
IPI Advisor Manual | February 2017 Page 35
The 2017 MnVFC Site Visit Paperwork Chapter 4
bull It is recommended that sites download and review data weekly Discuss with sites that reviewing temperature monitoring device data also includes responding appropriately if they identify out-of-range temps
bull There is sometimes confusion about the difference between a data logger and a continuous temperature monitoring system Here are some differences
Data Loggers Continuous Monitoring Systems Have an external display similar to thermometers May or may not have an external display Have a detachable probe Probe is usually attached to transmitter Need to be plugged into the computer or cradle to download information on a regular schedule
Wirelessly sends data to computer system
Create a file of data that needs to be saved on the computer
Data is stored within the system not a separate file
Doesnrsquot allow documentation of twice a day temperature checks in the file
May allow documentation of twice a day temperature checks within the system
More about the 2018 requirement for a continuous temperature monitoring device
Required Features bull The continuous temperature monitoring device must have Continuous monitoring and recording capabilities to track and record temperatures over time The capacity to routinely download temperature data to a computer (recommended at least weekly) or wirelessly transmit data Detachable probe in a bottle filled with a thermal buffer (eg bio-safe glycol) if the data logger needs to be detached in order to download data Active temperature display
Recommended Features bull MnVFC recommends continuous temperature monitoring devices with Alarm for out-of-range temperatures Accuracy within +-1degF (+- 05degC) Low battery indicator Display of current minimum and maximum temperatures Memory storage of at least 4000 readings User programmable logging intervals (eg the user can set how often the device records the temperature)
Note that these are all currently recommendations not requirements yet
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
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The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 45
Goal of this question Ensure the temperature monitoring device is properly calibrated The certificate of calibration testing means that the device has been tested and it is accurately measuring temperatures within established testing limits The certificate of calibration ensures that the device meets all the required components
Helpful information bull The provider is always responsible for having a current certificate of calibration (or copy) on-site
bull To be considered ldquovalidrdquo a certificate of calibration must contain these required elements Modeldevice name or number Serial number
4 Storage amp Handling Per Unit Certificate of Calibration Testing
Review CDC Requirement
Certificates of calibration testing provide confidence that the temperature monitoring device is measuring temperaturesaccurately All units storing VFC vaccines must have a calibrated temperature monitoring device with a current and valid certificateof calibration testing All certificates must contain modeldevice name or number serial number date of calibration testing (report or issue date) and Instrument Passed testingInstrument in Tolerance (Recommended uncertainty = +-05ordm C (+-1ordm F))
Question 45
Note to Reviewer
A
B
C
D
E
Review the certificate of calibration testing for the temperature monitoring device in this section of the storage unit and answer the questions below
bull How to determine certificate of calibration testing expiration date 1) Identify the certificate issuecalibration date 2) Apply the Immunization Program-required frequency for calibration testing Example If the
issuecalibration date is 12312013 and Immunization Program policy requires testing every twoyears the expiration date is 12312015
bull Certificates must include all of the below bull ModelDevice Name or Number bull Serial Number bull Date of Calibration Testing (Report or Issue Date) bull Instrument Passed testing (Instrument in Tolerance)
Is there a certificate of calibration testing for the temperature monitoring Yes device in this section of the storage unit No [X]
What is the date of calibration for the temperature monitoring device in this section of the storage unit
What is the certificatersquos date of expiration based on ImmunizationProgram policy (See note to reviewer to determine expiration date) [X] Follow-up is required if
certificate is expired
Does the certificate contain all the necessary items listed in the Note to Yes Reviewer No [X]
Who is responsible for supplying the current and valid certificate of Provider calibration for this temperature monitoring device
Date of calibration testing (report or issue date) Note If there is no expiration date the certificate expires 2 years from the date of calibration Whether the instrument passed or failed testing (or instrument in tolerancenot in tolerance)
bull Recommended element Documented uncertainty of +- 1degF [05degC]
If these elements are present the certificate is considered valid If the certificate contains information about the recommended element or the entity that issued the certificate that is helpful but not required
To determine if a certificate of calibration testing was issued by an appropriate entity check to see if the certificate indicates one or more of these items (this is the wording used to help sites evaluate if their calibration is accurate but is not required on the certificate itself to be considered valid)
bull Conforms to ISO 17025 bull Performed by an ILACMRA Signatory body accredited laboratory You can review this list of the ILAC MRA and Signatories (httpilacorgilac-mra-and-signatories)
bull Traceable to the standards maintained by NIST bull Meets specifications and testing requirements for the American Society for Testing and Materials (ASTM) Standard E2877 tolerance Class F (le 05 degC) or better
bull Includes reference to another acceptable accuracy validation method such as comparison to other traceable reference standards or tests at thermometric fixed points
Note CDC recommends that certifications be issued for the entire monitoring unit (detachable probe data logger etc) and not individual certificates for each component
IPI Advisor Manual | February 2017 Page 37
The 2017 MnVFC Site Visit Paperwork Chapter 4
For 45 E the provider is always responsible for supplying the current and valid certificate of calibration for a temperature monitoring device
bull Tip If the temperature monitoring device has a sticker on the back with the calibration date the site can usually call the company who calibrated the device and get a copy of the certificate if they donrsquot have one
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 46 4 Storage amp Handling Per Unit Probe Placement
Question 46 Is the probe properly placed in this section of the storage unit
Note to Reviewer ldquoProperlyrdquo means that the probe in a commercial or household unit is placed in a central area of the unitdirectly with the vaccines Probes should not be placed in the doors near or against the walls close to vents or on the floor of the unit The only allowable exemption related to this requirement is for providerswho have pharmaceutical storage units (built for vaccine storage) that have either (1) a built-intemperature monitoring device OR (2) a dedicated port for the probe that dictates the placement of theprobe
Answers (Choose one)
Yes No [X]
Review CDC Requirement
The probe must be placed in a central area of the section of the storage unit directly with the vaccines in order to properly measurevaccine temperature The probe should not be placed in the door near or against the walls close to vents or on the floor of theunit For pharmaceutical units with a built-in temperature monitoring device or a dedicated port for a probe that is not in thecenter of the section of the storage unit consult your Immunization Program for guidance on placement
Goal of this question Make sure the temperature monitoring device is in the best location to accurately measure the temperature of the vaccines stored in the unit
Helpful information bull The probe of the temperature monitoring device should be placed directly with the vaccines in the middle of the unit The ONLY allowable exception is for pharmaceutical storage units that have either a built-in thermometer or a dedicated port for the probe that indicates placement of the probe
bull Temperatures can vary within the unit especially household units bull Call MDH at 651-201-5522 if you have questions
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Guide (wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml)
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The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 474 Storage amp Handling Per Unit Temperature Documentation
Question 47 Review the temperature documentation over the past three months for this section of the storage unit todetermine whether the provider has a process in place for properly documenting temperatures twice aday Answer the questions below
A Are there two temperature readings recorded for this section of the storage unit per day
Yes No [X]
B Is there a time date and name (or initials) recorded for each reading Yes No [X]
C What is the current temperature and minmax temperatures (if available) inthis section of the storage unit Use the reviewerrsquos thermometer if the providerrsquos temperature monitoringdevice does not have a current valid certificate of calibration testing or the probe is not properly placed in this section of the storage unit
Current Temperature Minimum Temperature Maximum Temperature Fahrenheit Celsius
D Based on your review of the providerrsquos recent temperature documentationincluding the current temperature is this section of the storage unitmaintaining appropriate temperatures
Yes No [X] Not enough information [X]
Review CDC Requirement
Vaccines must be stored under appropriate temperatures as described in the package inserts at all times Acceptable temperature ranges vary by vaccine type and the range is 36deg F and 46deg F (2deg C and 8deg C) and for frozen vaccines the range is -58deg F and +5deg F (shy50deg C and -15deg C) Exposure to temperatures outside of those included in the package inserts could affect vaccine viability andultimately could leave children unprotected against vaccine-preventable diseases In order to maintain awareness of storage unittemperatures and ensure that vaccines are being stored at appropriate temperatures at all times VFC providers are required to monitor and document temperatures for all vaccine storage units at least twice a day Temperature documentation must contain (1) at least two temperature readings per day (2) the time and date of each reading and (3) the name (or initials) of the personwho assessed and recorded the readings CDC also recommends that VFC providers record the minimum and maximumtemperatures of each unit once each workday (preferably in the morning)
Goal of this question Ensure the temperature is being monitored twice daily is within the required range and documented correctly Use your thermometer to check the temperature if the sitersquos temperature monitoring devicersquos probe is not properly placed or there is not a current certificate of calibration Place your thermometer in the unit at the beginning of the visit to allow sufficient time to reach an accurate temperature The purpose of using your thermometer is to ensure the vaccine is being stored at the proper temperature not to ldquovalidaterdquo their reading
Question 47 D is an assessment question based on information you have learned during your visit You might answer ldquonot enough informationrdquo if the unit is new and they donrsquot have at least three months of data or if the unit is only used as overflow and they are inconsistent with temperature monitoring Mark ldquoNordquo if you have reason to believe the storage unit is not maintaining temperatures properly
Helpful information bull All sites must document temperatures twice a day every day the site is open even if they have a data logger or continuous monitoring system
bull Sites can document the information electronically with some continuous monitoring systems as long as it can show what the current temp is the date time and initials of the person checking ndash this needs to be someone at the site ndash not checking remotely or centrally for a large site or system The site must be able to produce these records during their site visit Reviewing these files can be a challenge due to large volumes and lots of paper
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Temperature Logs on Managing Vaccine (wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml)
IPI Advisor Manual | February 2017 Page 39
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 484 Storage amp Handling Per Unit Temperature Excursions
Question 48 In the event that a temperature excursion(s) occurred in this unit within the last three months requestand review documentation of actions taken to determine whether the provider has a process for properlyaddressing excursions Answer the questions below
A Were vaccines in this unit exposed to out-of-range temperatures in the lastthree months (including today)
Yes No (If no skip to question 49)
B Did the provider quarantine and label vaccines as ldquoDo not userdquo Yes No [X]
C Did the provider place vaccine in a unit where it can be stored under properconditions if applicable
Yes No [X]
D Did the provider contact the Immunization Program to report theexcursion
Yes No [X]
E Was the manufacturer contacted for documentation supporting theusability of the vaccine
Yes No [X]
Review CDC Requirement
The provider must document all excursions and actions taken including the following (1) Quarantine and label vaccines as ldquoDO NOTUSErdquo (2) Place vaccines in a unit where they can be stored under proper conditions (3) Contact the Immunization Program to report an excursion and (4) Contact the vaccine manufacturer to obtain documentation supporting the usability of the vaccine
Goal of this question Address any out-of-range temperatures (temperature excursions) identified in reviewing the last three months of temperature logs or during the site visit If there were any out-of-range temperatures did the site respond appropriately to the situation This is a great opportunity to discuss what to do in the event of an excursion The Clinicians Storage and Handling Mishap Checklist is in the IPI Site Visit information folder and is a good review of the process
Helpful information bull Sites need to know that an excursion does not automatically mean that exposed vaccines are non-viable or unusable Exposed vaccines must be quarantined (marked ldquoDo Not Userdquo) and stored under proper conditions until they have received information from vaccine manufacturers regarding the viability of the vaccine
bull Sites must inform MDH when an excursion occurs
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Clinicians Storage and Handling Mishap Checklist (wwwhealthstatemnusdivsidepcimmunize ipivaxchklstpdf)
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Question 49
Goal of this question Ensure proper placement of vaccines in the storage unit
Note These are all recommendations (best practices) not requirements
Helpful information bull Store vaccine in the middle of the compartment two to three inches away from the coils walls floor and cold air vent The temperature near the floor and walls of the unit differs from that in the middle of the compartment and the cold air vent can freeze refrigerated vaccines
4 Storage amp Handling Per Unit Vaccine Placement
Question 49 Look inside the unit to answer the questions below
A Are vaccines placed in the middle of the unit with space between vaccinesand the sideback of the unit to allow cold air to circulate
Yes No [O]
B Are vaccines stored in their original packages Yes No [O]
C Are there water bottles (for refrigerators) or frozen water bottles (forfreezers) in the unit
Yes No [O]
D Are vaccines store in the doors vegetable bins under or near cooling ventsor on the floor of the unit
Yes [O] No
E Is food being stored in the unit Yes [O] No
Review CDC Recommendation
Vaccines should be stored in their original manufacturer (or CDC centralized distributor) packaging They should be placed in the middle of the unit with space between the vaccines and the sideback of the unit to allow cold air to circulate Vaccines SHOULD NOT be stored in the doors vegetable bins or floor of the unit or under or near cooling vents and there should not be any food inthe unit Water bottles (for refrigerators) or frozen water bottles (for freezers) should be placed throughout each storage unit inorder to (1) stabilize or extend temperatures during a power outage and (2) to serve as physical blocks preventing the placementof vaccines in areas of the unit that are at higher risk for temperature excursions (such as in doors vegetable bins floor ornearunder cooling vents)
bull Vaccines should be kept in their original packaging to Protect them from light Help prevent medication errors by making labels easier to read Provide a moisture barrier that serves as insulation in case of an out-of-range temperature power outage door left open or mechanical failure Simplify managing vaccine inventory
bull Store water bottles in the doors on the floor and near the cold air vent in the refrigerator and frozen water bottles in the freezer to help maintain a stable temperature if there is a power failure and when the door is opened frequently Too many water bottles in the door can prevent the door from closing tightly Mark water bottles ldquoDo Not Drinkrdquo
bull Do not store vaccine in the door or drawers of the refrigerator or freezer Vegetable bins and crisper drawers should be removed from refrigerators or used to store other medical supplies or water bottles
bull If vaccine is stored in a household combination refrigeratorfreezer The top shelf should not be used for storing vaccine because the cold air vent blowing from the freezer will freeze vaccine located there If you must use the top shelf of this type of unit place water bottles underneath the cold air vent to prevent vaccine from being stored there It is recommended that only the refrigerator be used for vaccine storage and a separate stand-alone freezer be used to store frozen vaccine
bull Must not store food or beverages in the refrigerator or freezer because frequent opening of doors can lead to temperature variations that may affect vaccine viability There is also a risk of contaminating vaccines
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Guide (wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml) bull Vaccine Storage Tip Sheet on IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml)
IPI Advisor Manual | February 2017 Page 41
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 4104 Storage amp Handling Per Unit Disconnection from Power Source
Question 410 Ask the provider to demonstrate what measures are taken to ensure that vaccine storage units are notaccidentally physically disconnected from the power supply Which of the following describes the measure(s) taken on this unit
Note to Reviewer bull Large hospitals and healthcare systems may not have the ability to demonstrate labels on plugs or circuitbreakers In such cases verify that the practice has a comprehensive policy and standard operatingprocedures in place to prevent the vaccine storage unit from being physically disconnected from thepower supply
bull While back-up generators may ensure power to the overall facility this question ONLY addresses thevaccine storage unit being accidentally disconnected from the power source either through the plug orthe circuit breaker
Answers A ldquoDo not disconnectrdquo labels on the plug (Choose all that B ldquoWarningrdquo label on the circuit breaker box
apply) C Hard-wired (ie built-in) and has a ldquoDo not disconnectrdquo label on thecircuit breaker box D Hospital or large health care system with a comprehensive written policyand standard operating procedures detailing measures taken to preventvaccine storage units from being accidentally disconnected from the powersupply E No acceptable measures for preventing accidental disconnection frompower supply [X]
[X] The response is non-compliant if only A only B or E is selected
Review CDC Requirement
VFC providers must take steps to protect the power source for all vaccine storage equipment by means of having clear warninglabels on both the plug and the circuit breaker associated with all vaccine storage units Large hospitals and healthcare systems canmeet this requirement by demonstrating that they have comprehensive policies and standard operating procedures to preventvaccine storage units from being physically disconnected from the power supply
Goal of this question Decrease the chance that a vaccine storage unit will be accidently unplugged or power will be turned off while vaccine is in the unit This question addresses only what measures the site has taken to ensure the storage unit is not physically disconnected from its power source
If the site uses labels on the plugs and circuit breakers perform a visual inspection to assess whether the way the stickers are positioned make it clear and obvious to anyone that these units are not to be disconnected
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Do Not Unplug and Warning stickers are included in the folder or available to order on the For
Professionals Order Form (wwwhealthstatemnusdivsidepcimmunizeordermathtml)
Note Once you have completed the 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet for each unit return to the questionnaire to complete sections 5 and 6
Page 42 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
- -
Section 5 Storage amp Handling Site-Wide Question 51
5 Storage amp Handling Site Wide Discussion of Cost amp Quantity of Vaccine
Question 51 Have a discussion with the provider about the cost and quantity of VFC vaccines they are responsible for annually Address the points listed in the note to reviewer below
Note to Reviewer bull Vaccine Shipped (Required) Share the cost of VFC vaccines shipped to the provider in the last calendaryear to make sure the provider understands the contribution made by the VFC Program to their practiceFor new providers who do not have ldquocalendar yearrdquo data share either the actual cost of their currentinventory or use the cost of 10 VFC doses of each of the ACIP-recommended vaccines (approximately $7000) to help estimate their annual cost
bull Storage amp Handling (Required) Make sure the provider understands the cost of vaccines for which they are responsible when they make decisions about purchasing recommended vaccine storage and temperature monitoring equipment
Answer I have discussed with the provider the cost and quantity of vaccines ordered in the previous calendar year
Goal of this question Inform sites of the quantity and value of vaccines that they receive as part of the MnVFC program Providers often donrsquot realize the value of the vaccine in their unit This information is included on your clinic list and on the one page site-specific information
Helpful information bull This discussion must occur and the box on the questionnaire must be checked bull If there isnrsquot actual vaccine value information available tell the site that one vaccine order that includes a box of each of the ACIP recommended vaccines costs approximately $7000
bull MDH may not have specific information for individual sites if they receive vaccine from a central warehouse or pharmacy For those sites MDH will give you numbers for the whole system so you can discuss system wide data as appropriate If individual site information is also included it is usually just varicella-containing vaccines that must be shipped directly to the site
Question 52
5 Storage amp Handling Site Wide Dorm Style Units
Question 52 Determine whether the provider has any dorm-style units on site and answer the questions below
Note to Reviewer A dormitory-style refrigerator is a unit that has both refrigerator and freezer compartments behind a singleexterior door Dorm-style units also have an evaporator plate (cooling coil) which is usually located insidean icemaker compartment (freezer) within the refrigerator
A Does the provider have any dorm-style units that are used at any time tostore vaccines
Yes [X] No (Skip to question 53)
B Does the provider have sufficient space in existing compliant vaccinestorage units to store all vaccines without use of the dorm-style unit at any time
Yes No [X]
Review CDC Requirement
Dorm- and bar-style units are prohibited for vaccine storage Vaccines stored in dorm-style units are considered non-viable and must be returned to the centralized distributor CDC recommends the following vaccine storage unit types (in order of preference)pharmaceutical grade stand-alone or combination units (preferred) householdcommercial stand-alone unitshouseholdcommercial combination units using the refrigerator section only
Goal of this question Ensure no vaccine is stored in dorm-style units even for short periods of time Encourage them to label any units ldquoNo Vaccine Storage Allowedrdquo Vaccine stored in these units is considered non-viable If a site is using a dorm-style unit call the MnVFC program (651-201-5522)
Resource Section 8 in the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 43
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 535 Storage amp Handling Site Wide Storage Unit Space Availability
Question 53 Does the provider have sufficient room across storage units to store current stock as well as anyadditional stock acquired during peak season without overcrowding
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have sufficient storage space to accommodate vaccine stock at the busiest time of year without overcrowding
Goal of this question Ensure that sites have sufficient space in their units to maintain vaccines at the busiest time of year Overcrowding of vaccine limits air circulation and affects the unitrsquos ability to maintain stable temperatures
Helpful information bull Look for signs of overcrowding such as vaccines that are pushed up against the wall bins that are overflowing or storage units that are full during non-peak seasons
Discuss immediate actions if the unit is overcrowded Move some of their vaccines order less vaccine more frequently (once per month preferably) andor purchase another storage unit for overflow
Resource bull Section 8 MnVFC Policy and Procedure Manual
Page 44 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 545 Storage amp Handling Site Wide Expired Vaccines
Question 54 Look in each unit Are there expired vaccines in any of the vaccine storage units at this site
Answers (Choose one)
Yes [X] No
Review CDC Requirement
Vaccines should be rotated weekly and when a new shipment comes in so that longer-dated vaccines are stored behind shorter-dated vaccines If vaccines expire they can no longer be stored in the same storage unit with viable vaccines They must be placedin a container or bag clearly labeled ldquoDo not userdquo and separated from viable vaccines to prevent inadvertent use Expired vaccinemust be returned to the centralized distributor within six months of expiration
Goal of this question Ensure there is no expired vaccine in any storage unit
Helpful information bull Sites can prevent their stock from expiring by rotating vaccines every week andor when a new shipment arrives Longer-dated vaccines are stored towards the back of the unit and shorter-dated vaccines are up front
bull Pay attention to vaccines that expire within the next three months Consider transferring vaccine that will expire soon to another MnVFC-enrolled site that will use the vaccine preferably a site close by It is the transferring sitersquos responsibility to arrange the transfer of the vaccine Be sure to complete the MDH Vaccine Transfer Record form and send it to MDH If they are having difficulty finding a location to accept vaccine contact MDH
bull This is a great opportunity to educate sites about the MDH Nonviable Vaccine Form and the process for returning vaccine The VFC program does get some credit for taxes and fees on vaccine that is returned to the distribution center
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MDH Nonviable Vaccine Form and MDH Vaccine Transfer Record on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfcformshtml)
IPI Advisor Manual | February 2017 Page 45
The 2017 MnVFC Site Visit Paperwork Chapter 4
- -
-
Question 555 Storage amp Handling Site Wide Back up Thermometer
Question 55 Does the provider have a readily available back-up thermometer with a current and valid certificate ofcalibration testing
Note to Reviewer ldquoReadily availablerdquo means that the thermometer is available to perform twice-a-day monitoring for a unit asrequired CDC recommends that the back-up thermometer be maintained on site
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have a readily available back-up thermometer with a current and valid certificate of calibration testing Toprevent the certificates of calibration testing of the primary and back-up thermometers from expiring at the same time the date of calibration testing (or issue date) of the back-up thermometer should be different from the date of calibration testing (or issue date) of the primary thermometer As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meetsVFC program requirements
Goal of this question Ensure sites have one calibrated back-up thermometer onsite that is readily available in the event that the temperature monitoring device in unit fails transportation of vaccine is needed or there are other unexpected circumstances
Helpful information bull As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meets VFC Program requirements
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 56 5 Storage amp Handling Site Wide Preparation of Vaccine
Question 56 When does this provider prepare vaccine for administration to the patient
Note to Reviewer For mass vaccination clinics if one type of vaccine is offered providers may pre-draw up to 10 doses Ifusing pre-filled syringes pre-drawing also means activating the syringe by removing the needle guard orattaching a needle
Answers (Choose all that
apply)
Prepare dose immediately before administration Pre-draw doses for upcoming patients (in a regular clinicpractice) [O] Pre-draw up to 10 doses (in a mass-vaccination clinic) Pre-draw more than 10 doses (in a mass-vaccination clinic) [O] Other [O]
Review CDC Recommendation
CDC recommends preparing vaccines immediately prior to administration in order to assure viability of vaccine and prevent vaccinewastage Vaccines that are not administered immediately are at risk of exposure to temperatures outside of the required rangewhich can affect vaccine viability and ultimately can leave children unprotected against vaccine-preventable diseases
Goal of this question Discuss proper timing and preparation of vaccine(s) for administration These are recommendations not requirements
Helpful information bull Educate staff on the importance of preparing vaccine immediately before administration Pre-drawing of vaccines may lead to concerns related to vaccine viability potency sterility and wastage
Page 46 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 6 Inventory Question 61
6 Inventory Inventory Comparison
Question 61 Visually inspect storage units to determine if existing supply of vaccines proportionately mirrorspopulations served Choose the most accurate statement below
Note to Reviewer bull CDC recommends that providers maintain a four-week supply of inventory bull For this question do not take into account vaccine types that the provider does not order Here simply
make sure that overall the vaccines in the providerrsquos storage units are available in sufficient amounts toserve their patient population
Answers (Choose one)
The current vaccine inventory proportionately reflects the populations identified Only public stock is insufficient [X] Only private stock is insufficient [X] Both public and private stock are insufficient [X] Site uses the replacement method but does not appear to have enough vaccine for their population [X] Other [X]
Review CDC Requirement
VFC providers must order and stock routine vaccines in accordance with their patient population in order to prevent missedvaccination opportunities Having sufficient amounts of all stocks prevents the inadvertent use of VFC vaccines for non-VFC-eligiblepatients and vice versa
Goal of this question Assess whether the site is ordering appropriate quantities of vaccine for the population they serve at their site
Helpful information bull If the site sees 30 percent private-pay patients and 70 percent VFC the stock in their storage units should reflect that proportion If you donrsquot know you can ask the site about their population
bull This is meant to be a general assessment so in a big site if they have only a small amount of vaccine that may indicate an issue with vaccine management
bull CDC recommends smaller more frequent orders (ie monthly) rather than large orders to minimize the amount of vaccine loss if an incident occurs during shipment or in the storage unit Sites should not order more frequently than once a month
bull Sites using the replacement method will only have one stock but it should appear to be large enough for their population
bull Only assess the vaccine types that the site currently stocks in their unit We know there are sites that do not offer all ACIP-recommended vaccines for various reasons That issue will be addressed in question 62
IPI Advisor Manual | February 2017 Page 47
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 626 Inventory ACIP Recommended Vaccines
Question 62 Review providerrsquos current inventory to answer the questions below
A Does the provider offer all routine ACIP-recommendedvaccines for their patient population
Yes (Skip to question C) No [X] Offers all except varicella because direct ship ofvaccine is unavailable from manufacturer
B Which routine vaccines are NOT being offered DTaP Hepatitis A Hepatitis B HIB HPV Influenza Meningococcal
MMR Pneumococcal Polio Rotavirus TdapTd Varicella
C According to Immunization Program Policy does theprovider make accessible all non-routine ACIP-recommended vaccines for those VFC patients whomeet the criteria for receiving them
Yes (Skip to question 63) No [X]
D Which non-routine vaccines are NOT being offered Pneumococcal polysaccharide vaccine (PPSV23) Meningococcal Group B (MenB) Other
Review CDC Requirement
VFC providers agree to comply with immunization schedules dosages and contraindications that are established by the Advisory Committee on Immunization Practices (ACIP) for the vaccines identified and agreed upon in the Provider Agreement UNLESS bull In the VFC providers medical judgment and in accordance with accepted medical practice the VFC provider deems such
compliance to be medically inappropriate for the child bull The particular requirements contradict state law including laws pertaining to religious and other exemptions The VFC program entitles children to the following vaccines DTaP Hepatitis A Hepatitis B HIB HPV Influenza MeningococcalMMR Pneumococcal Polio Rotavirus TdapTd and Varicella VFC providers are also required to ensure that VFC-eligible children have access to non-routine vaccines as needed
Goal of this question Assess if the site is offering all the ACIP-recommended vaccines for the population they serve and these vaccines are in stock on the day of the visit It is important that every MnVFC-eligible child that comes to a providerrsquos office for an immunization is vaccinated
Helpful information bull The Advisory Committee on Immunization Practices (ACIP) is a group of medical and public health experts that develops recommendations on how to use vaccines to control diseases in the United States
bull Specialty providers are not required to offer all routine vaccines but should provide the vaccines appropriate for their population
bull If the site does not offer all routine ACIP-recommended vaccines appropriate for their population check the ldquoNordquo box in Part A then check the appropriate box(es) in Part B for any vaccines not offered Please contact MDH as this situation offers us the opportunity to provide education to the site
bull For non-routine vaccines they must either be in stock or the site must have an alternative protocol in the routine management plan that ensures these children have access when applicable
Resources bull IAC Diseases and Vaccines (wwwimmunizeorgvaccines) bull CDC Advisory Committee on Immunization Practices (ACIP) (wwwcdcgovvaccinesacipindexhtml)
Page 48 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 636 Inventory Separation of Stock
Question 63 Observe how the provider differentiates stock in each storage unit to answer the questions below
A Is it clear which vaccines belong to public stock andwhich belong to private stock
Yes No [X] Not applicable replacement site
B Is it clear which vaccines belong to VFC stock andwhich belong to UUAV stock
Yes No [X] Not applicable replacement site Not applicable not UUAV-enrolled site
Review CDC Requirement
In order to ensure that VFC vaccines are only administered to VFC-eligible children VFC providers that serve both VFC and non-VFCshyeligible children must maintain their vaccine inventories in such a way that they can clearly differentiate public stock from privatestock as well as VFC from other public stock
Goal of this question Assess whether the site can distinguish between MnVFC vaccine and private vaccine If they participate in the Uninsured and Underinsured Adult Vaccine (UUAV) program they should also be able to distinguish between MnVFC stock and UUAV stock Some sites use labels bins boxes etc to differentiate their stock If it is not clear how the site differentiates their stock discuss vaccine management with the staff For follow-up call MDH to discuss doing a follow-up site visit
Sites using the replacement method will not have separate stocksmdashthis is an approved alternative method for keeping track of vaccine
Resource bull Section 10 of the MnVFC Policy and Procedure Manual
IPI Advisor Manual | February 2017 Page 49
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
MnVFC Site Visit Storage and Handling Per Unit Answer Sheet 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet MnVFC PIN ___________________
Question number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
Temperature Monitoring Device Questions Questions 43 47 must be answered separately for the freezer and refrigerator if the unit is a combo Be sure to document responses in the appropriate column
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
All the questions on the Site Visit Storage amp Handling Per Unit Answer Sheet have been discussed previously in section 4 of this manual Use this sheet to record information about all the units at the site visit You will need one sheet for each unit If it is a combination unit (either pharmaceutical or household) you can record both sections on one sheet If they have stand-alone units use one sheet for each unit Do not enter the answers to the questions in section 4 of the questionnaire
If you need more information about any of the questions refer back to the main questionnairemdashthe complete question additional guidance including notes to the reviewer and the CDC requirements are there Also if the site is not meeting the requirement you will go back to the questionnaire to complete the ldquoActions if Non-compliantrdquo section including the root cause analysis and follow-up sections
When you have completed the assessment of all the storage units remember to go back to the questionnaire to complete sections 5 and 6
Page 50 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
ndash
ndash
MnVFC Provider Follow-up PlanThe goal of the Provider Follow-up Plan is to communicate with the site all of the VFC requirements any unmet requirements found during your site visit and the timeline for completing the required action The left hand column is a box to check for ldquoUnmetrdquo requirements
Helpful information bull The form can be used to review what the site is doing well and what they need to work on
bull For requirements that have specific documentation that needs to be sent to you use the notes section
2017 MnVFC Provider Follow-up Plan Site _______________________________________________ MnVFC PIN ____________ Date of Visit ___________
Thank you for participating in this MnVFC compliance site visit Please review this visit summary including follow-up actions and timelines for completion Unmet MnVFC requirements and recommendations have a checked box next to them The goal of this plan is to support you with successfully implementing the program and improving access to vaccines for VFC-eligible children
Unmet Question VFC Requirements Section 1 Changes to Key Staff
Q12 Change in the Medical Director Immunization Manager Vaccine Coordinator or back-upKey Staff must be communicated to the immunization program by emailing healthmnvfcstatemnus Changes Notes
Q12 Key staff must complete the annual training on VFC program requirements and print theAnnual Training certificate of completion Documentation Required Action
Staff that have not completed the MnVFC online training must complete it and send acopy of the certificate to the reviewer Training can be found on the MnVFC website (wwwhealthstatemnusvfc) Due date 1 month
Notes
Unmet Question VFC Requirements Section 2 Eligibility
Q21 Provider staff must possess a working knowledge of all VFC eligibility criteria and use thoseVFC Eligibility criteria to screen children prior to administering VFC vaccines
Categories Notes
bull This form provides documentation needed for follow-up actions when you send your thank you email
The second to last page of the Provider Follow-up Plan has a summary of the MnVFC program recommendations These are to remind the site about best practices they may want to improve upon even though they are not yet requirements of the program For example you could discuss the recommendation about storage units if they currently have a combination household unit and are using both sections
The last section is for your signature and the person you met with In most sites it will be the immunization manager or vaccine coordinator who signs the form unless the medical director attended the site visit You keep the original copy and the site will need to keep a copy for themselves
To be completed by the site visit reviewer
I acknowledge that a VFC site visit was performed on __________________ (visit date) The follow-up plan which includes a list of all current VFC program requirements and recommendations assessed during the visit and any required follow-up actions was provided at the end of the visit
Site visit reviewer
Phone
Reviewer Signature Date
To be completed by the provider
I acknowledge that our practice took part in the VFC site visit noted above I understand the findings of the visit and any required actions that must be taken by our office in order to meet VFC program requirements
Medical Director (or designee) Name Title
Medical Director (or designee) Signature Date
IPI Advisor Manual | February 2017 Page 51
The 2017 MnVFC Site Visit Paperwork Chapter 4
After the Site Visit Send a thank you email highlighting the unmet requirements documents you need from the site to resolve the issue(s) and the date you need them Make sure to include the link to the Site Visit Survey (httpssurveyvovicicomseashxs=56206EE334CE0B14)
Please refer to Chapter 3 for more information about future follow-up required after the visit including forms and documentation
Resource bull Sample Thank You letter on IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml)
Chapter 5
IPI Advisor Resource List MnVFC Program 651-201-5522
MnVFC wwwhealthstatemnusvfc
bull Separate Stock and Replacement Method Policies and Procedures Manuals bull Online trainings bull MnVFC Announcements sign up to receive them via email bull Ordering MDH vaccine bull MnVFC forms Screening forms Reporting forms Others MDH Nonviable Vaccine Form MDH Vaccine Transfer Record and Vaccine Borrowing Report
bull MnVFC promotional materials bull Immunization Billing Guidance for MnVFC and Immunization Billing Guidance for MnVFC Replacement Sites Immunization Practices Improvement Program (IPI) wwwhealthstatemnusdivsidepcimmunizeipi
bull IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml) bull IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml) IPI Resource Folder Contents (wwwhealthstatemnusdivsidepcimmunizeipiipifolderpdf)
Minnesota Immunization Information Connection (MIIC) wwwhealthstatemnusmiic
bull MIIC regions and regional coordinators
Clinical Practice MDH Immunization Program wwwhealthstatemnusimmunize
Got Your Shots News wwwhealthstatemnusdivsidepcnewslettersgys
MDH Immunization Information for Health Care Providers wwwhealthstatemnusdivsidepcimmunizehcp
bull Got Your Shots A Providers Guide to Immunization in Minnesota bull Vaccine protocols bull Forms for tracking patient immunizations bull Immunization schedules for Health Care Providers Immunization Action Coalition (IAC) wwwimmunizeorg
bull Ask the Experts bull VISs (Vaccine Information Statements and translations) bull Administration screening questions bull Medical management of vaccine reactions bull Order form for Californiarsquos Immunization Technique DVD Best Practices with Infants Children and Adults
Page 52 IPI Advisor Manual| February 2017
IPI Advisor Resource List Chapter 5
CDC ldquoPink Bookrdquo wwwcdcgovvaccinespubspinkbookindexhtml
CDC Advisory Committee on Immunization Practices (ACIP) wwwcdcgovvaccinesacip
CDC Vaccines and Immunizations wwwcdcgovvaccines
VAERS reporting httpvaershhsgovindex
Storage and Handling Got Your Shots Providers Guide ndash Managing Vaccine wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml
MnVFC Guide to Temperature Monitoring Devices wwwhealthstatemnusvfc
MDH Clinicianrsquos Vaccine Mishap Checklist wwwhealthstatemnusdivsidepcimmunizeipivaxchklstpdf
MDH Vaccine Storage Guide wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml
CDC Vaccine Storage and Handling Toolkit wwwcdcgovvaccinesrecsstoragetoolkit
You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Vaccine manufacturer phone numbers wwwcdcgovvaccinespubspinkbookdownloadsappendicesFcontact-info-manufactpdf
IAC Checklist for Safe Vaccine Handling and Storage wwwimmunizeorgcatgdp3035pdf
IAC Donrsquot Be Guilty of These Errors in Vaccine Storage and Handling wwwimmunizeorgcatgdp3036pdf
Additional Resources Print materials from MDH ndash order forms wwwhealthstatemnusdivsidepcimmunizeordermathtml
Vaccine Education Center ndash Childrenrsquos Hospital of Philadelphia wwwchopeduservicevaccine-education-centerhomehtml
California Department of Public Health ndash Interactive training on vaccine administration and storage and handling handout on transporting vaccine and how to package wwwezizorg
IPI Advisor Manual | February 2017 Page 53
IPI Advisor Resource List Chapter 5
CDC vaccine price list wwwcdcgovvaccinesprogramsvfcawardeesvaccine-managementprice-listindexhtml
Vaccine Information Statements (VIS) wwwcdcgovvaccineshcpvisindexhtml
CEU Opportunities CDC Immunization Education and Training wwwcdcgovvaccinesedindexhtml
Immunization You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Page 54 IPI Advisor Manual| February 2017
- Introduction
-
- Welcome to the Immunization Practice Improvement (IPI) Program
- Contact Information
-
- Chapter 1
- Requirements to Participate in the MnVFC Program
- Vaccines for Children Program
- Chapter 2
- Reimbursement for MnVFC Visits
- Types of Visits
- Your MnVFC Clinical CoordinatorPlanner
- New IPI Advisor Training Requirements
- Your Role as an IPI Advisor
- Reasons MDH Would Do All or Part of a Visit
- Chapter 3
- Future follow-up
- Conducting the Visit
- Preparing for the Visit
- Information for the Visit
- Site Visit Checklist
- Scheduling the Visit
- Chapter 4
- After the Site Visit
- MnVFC Provider Follow-up Plan
- MnVFC Site Visit Storage and Handling Per Unit Answer Sheet
- Section 6 Inventory
- Section 5 Storage amp Handling Site-Wide
- Section 4 Storage amp Handling Per Unit
- Section 3 Documentation
- Section 2 Eligibility
- Section 1 Provider Details
- The Site Visit Reviewer Legend
- MnVFC Site Visit Questionnaire
- Required Paperwork for Site Visits
- Chapter 5
-
Page 22 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 22
2 Eligibility Billing Practices
Question 22 Is the individualdepartment responsible for billing able to clearly explain how they bill for both the costof vaccine and the vaccine administration fee for each of the eligibility categories below
A Medicaid-eligible Cost of Vaccine Do not bill ndash provided by VFC Admin Fee Bill Medicaid
Yes No [X]
B Uninsured Cost of Vaccine Do not bill ndash provided by VFC Admin Fee If billing can bill patient
Yes No [X]
C Underinsured Cost of Vaccine Do not bill ndash provided by VFC through FQHCsRHCs or deputized providers only all other providers cannotprovide VFC vaccine to underinsured patients Admin Fee If billing can bill patient
Yes No [X]
D American IndianAlaska Native(AIAN)
Cost of Vaccine Do not bill - provided by VFC unless patient is fully insured and parent chooses to use insurance Admin Fee If patient is Medicaid-eligible bill Medicaid if billingand patient is uninsuredunderinsured can bill patient if parentchooses to use private insurance for cost of vaccine billpatientinsurance
Yes No [X]
E Do individuals responsible for billing have access to the results of eligibility screening toensure proper billing
Yes No [X]
Review CDC Requirement
VFC providers must adhere to proper billing practices for vaccine administration fees and clearly understand that VFC vaccine isprovided at no cost to both the VFC provider and eligible children At no time should billing occur for the cost of VFC vaccine Whenadministering VFC vaccine providers should never bill two different ldquopayersrdquo (ie patient Medicaid insurance) for the samevaccine administration fee amount For Medicaid-eligible children Medicaid should be billed for the vaccine administration fee Forall other VFC-eligible populations the patient may be billed within the stateterritory cap established by the Centers for Medicareand Medicaid (CMS) However patients cannot be turned away or reported to collections for inability to pay the administration fee
Goal of this question Determine if the staff correctly understand how to bill patients that are eligible for the MnVFC program Billing appropriately ensures that children can receive low cost immunizations and the site is in compliance with the VFC program
bull If there is any indication that sites could be billing insurance companies or parents for VFC vaccines this should be investigated further
bull Most sites in Minnesota will bill Medicaid with the SL modifier ndash which indicates this is a Medicaid claim
bull The main point is to ensure the site is not billing uninsured children for VFC vaccine and are not charging them more than $2122 per vaccine for the administration fee
bull Non-compliance is usually unintentional and may be resolved with some training In rare cases it could be a glimpse into a larger problem where a site is intentionally billing for financial gain
bull If you think the site is billing inappropriately it is the responsibility of the IPI advisor to report concerns to MDH staff for further assistance
Resources bull Immunization Billing Guidance for MnVFC (wwwhealthstatemnusdivsidepcimmunizemnvfc billingtipshtml) or Immunization Billing Guidance for MnVFC Replacement Method Sites (www healthstatemnusdivsidepcimmunizemnvfcreplacementbillingtipsrephtml)
bull Section 2 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 23
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 232 Eligibility Vaccine Administration Fee
Question 23 Document the actual vaccine administration fee charged to non-Medicaid VFC-eligible patients (confirmwith billing department)
Answers Fee $ [X] Follow-up is required if the provider charges more than the fee cap establishedby the Centers for Medicare and Medicaid (CMS) for your stateterritory ($2122)
Review CDC Requirement
The VFC providerrsquos vaccine administration fee for non-Medicaid VFC-eligible children must not exceed the stateterritory vaccineadministration fee cap established by the Centers for Medicare and Medicaid (CMS) For current fee caps refer to Medicaid Program Payments for Services Furnished by Certain Primary Care Physicians and Charges for Vaccine Administration Under theVaccines for Children Program Final Rule (httpwwwgpogovfdsyspkgFR-2012-11-06pdf2012-26507pdf)
Goal of this question Ensure that sites are not charging more than the federal allowable vaccine administration fee of $2122
bull The Centers for Medicaid and Medicare (CMS) establishes a maximum fee that sites can charge to non-Medicaid-eligible VFC patients in each stateterritory for vaccine administration Health Plans usually negotiate this fee with the site but Medicaid will not pay more
bull If a parent cannot pay the vaccine administration fee the patient cannot be turned away or reported to collections VFC-eligible children must be vaccinated regardless of their ability to pay
bull If the person with whom you are conducting the site visit does not know the exact fee charged to non-Medicaid VFC-eligible patients ask to speak to someone who can verify the exact amount
bull If they are charging more than $2122 for the administration fee ndash please contact MDH staff for help with addressing this situation
Resources bull Immunization Billing Guidance for MnVFC (wwwhealthstatemnusdivsidepcimmunizemnvfc billingtipshtml) or Immunization Billing Guidance for MnVFC Replacement Method Sites (www healthstatemnusdivsidepcimmunizemnvfcreplacementbillingtipsrephtml)
bull Section 2 of the MnVFC Policies and Procedures Manual
Page 24 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 3 Documentation Question 31
3 Documentation Eligibility Screening amp Documentation
Question 31 To answer the questions below the provider must clearly demonstrate the patient intake processReview a minimum of 10 records that contain an immunization visit within the last 6 ndash 12 months
Note to Reviewer Criteria for Record Selection 1) Record selection must be completely random and the provider must not know prior to the visit which
records will be reviewed 2) Patient must have been 0-19 years of age at the last visit (Note Records of 19-year-old patients may
allow you to see if VFC vaccines are being used beyond the allowable age) 3) Must review a mix of public and private-pay patients (if applicable)
A Does the provider have a process that ensures that patients are screened forVFC eligibility at each visit and that screening results are documented at each visit
Yes No [X] (If no skip question F)
B Does the providerrsquos process ensure that staff administering vaccine know which vaccine stock to select from prior to drawing the vaccine
Yes No [X]
C Number of records reviewed If fewer than 10 records are reviewed select the reason why Provider does not have 10 patient records with immunizations in last 12 months
D Do all records contain date of the immunization visit and patientrsquos date of birth Yes No [X]
E Do all records contain the patientrsquos specific eligibility status associated with thedate of the immunization
Yes No [X]
F Do any of the providerrsquos records contain any evidence that the patient received vaccine for which they were not eligible
Yes [X] No
Review CDC Requirement
VFC providers must screen for and document VFC eligibility at each immunization visit Documentation must include the date of the visit and the childrsquos specific eligibility category VFC providers must use screening results to ensure that only VFC-eligible children receive VFC vaccine and that administration fees are billed for as appropriate Eligibility status must be readily available to staff administering vaccine prior to selecting which vaccine stock to use
Goal of this question Ensure the site is screening for eligibility and documenting the eligibility category in the medical record
Review a minimum of 10 records from within the last 6-12 months where the patient received an immunization You must review a mix of public and private pay patients (if applicable)
Random selection is important If the staff have pre-selected records for review do not use and identify additional randomly selected records to review
Helpful information bull Discuss upgrading the electronic health record to make documentation of VFC eligibility screening a required field Documenting eligibility screening in the immunization field promotes better MIIC data
bull Q 31 B Sites using the replacement method of vaccine management only have one stock so you will answer ldquoYesrdquo to this question
Resources bull Patient Eligibility Screening Record on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfcformshtml)
bull Section 1 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 25
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 32
3 Documentation Vaccine Dose Documentation
Question 32 Review a minimum of 10 patient immunization records from the last six months (or 12 months ifnecessary) to assess compliance with documentation requirements set forth by Statute 42 US Code 300aa-25 (See note to reviewer below)
Note to Reviewer Criteria for Record Selection 1) Record selection must be completely random the Provider must not know prior to the visit which records
will be reviewed 2) Patient must have been 0-19 years of age at the last visit (Note Records of 19-year-old patients may allow
you to see if VFC vaccines are being used beyond the allowable age)
Records are Compliant if they Contain ALL the Below Elements
bull Address of clinic where vaccine was administered bull Publication date of VIS bull Name of vaccine administered bull Name of vaccine manufacturer bull Date vaccine was administered bull Lot number bull Date VIS was given bull Name and title of person who administered the
vaccine
A Number of records reviewed
B Number of records that contain ALL required documentation elements
If fewer than 10 records are reviewed select the reason why Provider does not have 10 patient records with immunizations in last 12 months
[X] Follow-up isrequired if one ormore records do not meet requirements
Goal of this question Assess whether the site is documenting all required information in each patientrsquos medical record for every vaccine dose administered in accordance with the National Childhood Vaccine Injury Act
Resources bull Section 6 of the MnVFC Policies and Procedures Manual bull National Vaccine Injury Compensation Program (wwwhrsagovvaccinecompensation)
Question 33
3 Documentation Record Retention
Question 33 Is the provider able to demonstrate (preferred) or clearly describe how they maintain historical VFCeligibility documentation for three years
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers are required to maintain all records related to the VFC program for a minimum of three years (or longer if requiredby state law) and upon request make these records available for review VFC records include but are not limited to VFC screening and eligibility documentation billing records medical records that verify receipt of vaccine vaccine ordering records and vaccinepurchase and accountability records
Goal of this question Make sure the site understands they are required to keep all MnVFC screening documentation for at least three years either electronically or on paper This information should be available to you at the time of the visit and future visits
Resource bull Section 7 of the MnVFC Policies and Procedures Manual
Page 26 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 34
3 Documentation Borrowing Documentation
Question 34 Discuss borrowing practices with the provider to answer the questions below
Note to Reviewer bull To be considered ldquofully documentedrdquo documentation for each borrowed dose must include thefollowing information
Vaccine type borrowed Date the dose was administered Stock used (VFC or private) Reason appropriate vaccine stock was not used Patient name and date of birth Date dose was returned to appropriate stock
A Did the provider state that they had borrowed any vaccines (whetherdocumented or not) since the last VFC Compliance Site Visit
Yes No (If no skip to question 36)
B Are there any doses for which there is no documentation (ie provider hasindicated that doses were borrowed but cannot verify how many or why)
All doses are documented Some doses are not documented [X] No doses are documented [X] (if nodoses documented skip toquestion 36)
C Were all borrowed doses fully documented (See Note to Reviewer above) Yes No [X]
D Were all borrowed VFC doses either replaced or an order submitted to replacethe doses Yes No [X]
Review CDC Requirement
VFC providers are expected to maintain an adequate inventory of vaccine for VFC and non-VFC-eligible patients It is theresponsibility of the VFC provider to appropriately schedule and place vaccine orders VFC providers must also rotate stock to ensure timely use of short-dated vaccines Borrowing of vaccine between private and public inventories must be a rare unplanned occurrence and cannot serve as a replacement system for a VFC providerrsquos privately purchased vaccine inventory All instances ofborrowing must be properly documented reported and replaced
Goal of this question Assess vaccine accountability by verifying that children are receiving vaccine from the appropriate stock
Borrowing is when a fully insured child receives a dose of MnVFC vaccine or a MnVFC-eligible child receives a dose of private vaccine This should be a rare unplanned occurrence The site must document any borrowing of vaccine between stocks ideally on the VFC Borrowing Report Form If they are not currently using the form review it with them and encourage them to post it close to their vaccines It does not need to be sent to MDH but should be kept for 3 years and filed with their MnVFC documents to be reviewed whenever they have a regular or unscheduled (unannounced) site visit
Helpful information bull Understand and report on staffrsquos verbal (ie anecdotal) accounts of borrowing obtained during the visit Often sites do not know that what they do is considered borrowing or they think borrowing is acceptable and documentation isnrsquot needed so long as those vaccines are eventually replaced
bull Since sites using the replacement method only have one stock of vaccine they very rarely borrow bull This question asks for future follow-up in 6 months Make a note on your calendar and ask them to send you a copy of their borrowing reports for the previous 6 months with documentation of doses borrowed and replaced We will remind you if we donrsquot hear from you at the 6 month time frame Complete the Follow-up Form and attach the borrowing form
Resources bull Vaccine Borrowing Report on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfc formshtml)
bull Section 10 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 27
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 353 Documentation Borrowing Reasons
Question 35 Based on your discussion with the provider and a review of borrowing reports document the dosesborrowed for each reason and answer the questions below
Note to Reviewer bull Short-dated vaccines are doses that are likely to expire before they can be used bull Exchanging short-dated vaccines should only occur in practices that have a small number of private
patients
A Reasons for Borrowing a VFC Dose (Enter the number of _____ Private vaccine shipment delay (order placed on time but delay in shippingreceipt)
vaccine doses borrowed for each
reason in the spaces
_____ Private vaccine not useable on arrival (vials broken temperature monitor out of range) _____ Ran out of private vaccine between orders (provider orders not placed on time) [X]
provided) _____ Short-dated private dose was exchanged with VFC stock _____ Accidental use of VFC dose for a private patient (human error) _____ Replacement of private dose with VFC when insurance plan did not cover vaccine _____ OtherDocumented dose did not include reason for borrowing [X]
(Explanation Required) Reasons for Borrowing a Private Dose _____ VFC vaccine shipment delay (order placed on time but delay in shippingreceipt) _____ VFC vaccine not useable on arrival (vials broken temperature monitor out of range) _____ Ran out of VFC stock between orders (provider orders not placed on time) [X] _____ Short-dated VFC vaccine dose was exchanged with private dose _____ Accidental use of a private dose for a VFC-eligible patient (human error) _____ OtherDocumented dose did not include reason for borrowing [X]
(Explanation Required)
B Enter date range for instances of borrowing reviewed in the borrowing report Note If ldquoDate of earliest instancerdquo is not available use the date of the last VFC Compliance Visit If ldquoDate of last instancerdquo is not available use the date of thecurrent VFC Compliance Visit
Date of earliest instance
Date of last instance
C Does borrowing appear to be a routine practice Note To determine whether borrowing is a routine practice assess frequency of and repeating reasons for borrowing Examples Frequent accidental use of incorrect stock exchanging short-dated vaccines or issues with ordering and shipment
Yes [X] No
Goal of this question Determine the reasons why the site is borrowing vaccine
If sites are using the Vaccine Borrowing Report review the reasons for borrowing to help document borrowed VFC andor private doses If they have not been documenting borrowing on this report (or any other form) estimate their borrowing practices If you do not know the date range for their borrowing use the last site visit date to the current visit date The use of ldquootherrdquo as the reported reason for borrowing should be rare if ever and would require explanation and follow up
Helpful information bull Look to see if they routinely maintain insufficient amounts or types of vaccine to support their public and private patients that leads to borrowing
bull Pay attention to borrowing cases documented as ldquoaccidentalrdquo Repetitive accidental borrowing may indicate an issue with ordering processes or insufficient staff training
bull Borrowing is not a place to document wasted or lost doses bull The time period of the borrowing may give you clues about the root cause Were the borrowed doses concentrated in a short period or spread out across several months or a year Are all vaccine types being borrowed or just one
bull If borrowing seems to be an issue discuss vaccine management ordering procedures
Resources bull Vaccine Borrowing Report on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfc formshtml)
bull Section 10 in the MnVFC Policies and Procedures Manual
Page 28 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 36
3 Documentation Vaccine Management Plan
Question 36 Physically review the providerrsquos Vaccine Management Plan to answer the question below
A Does the provider have a Vaccine Management Plan Yes No [X] (If no skip to question 37)
B Does the plan list the current Immunization Manager Vaccine Coordinator andback-up
Yes No [X]
C Does the plan address proper vaccine storage and handling practices Yes No [X]
D Does the plan specify vaccine receiving procedures Yes No [X]
E Does the plan contain procedures for what to do with vaccine in the event of an emergency
Yes No [X]
F Does the plan contain procedures for vaccine ordering Yes No [X]
G Does the plan address inventory control (example stock rotation) Yes No [X]
H Does the plan address how to handle vaccine wastage Yes No [X]
I Does the plan address staff training and documentation on vaccine managementstorage amp handling
Yes No [X]
J Does the plan contain a review date that falls within the last 12 months Yes No [X]
K Has the plan been signed by the individual responsible for its content Yes No [X]
Review CDC Requirement
VFC providers must develop maintain and implement a Vaccine Management Plan for routine and emergency vaccinemanagement The plan must contain the current Vaccine Coordinator and back-up proper storage and handling practicesshipping and receiving procedures emergency procedures procedures for vaccine ordering inventory control (eg stock rotation)how to handle vaccine wastage and staff trainingdocumentation on vaccine management storage and handling The plan must bereviewedupdated annually or more frequently if changes occur A ldquoreview daterdquo and signature are required on all plans in order tovalidate that they are current
Goal of this question Evaluate the sitersquos plan for vaccine management It is especially important that they have a plan for emergency management of their vaccine in the case of equipment failure or power outage Encourage all sites to read and sign the MnVFC Policies and Procedures Manual and complete the emergency plan or be able to show you a plan of their own
If the provider is not able to physically show you the plan at the time of the visit or if the recorded review date is not within the last 12 months you must mark that this requirement is unmet The Vaccine Management Plan is important in times of emergency and it should be easy to access by any staff member at any time Encourage them to post the plan and put a copy with the packing supplies
Helpful information bull Encourage the site to fill in the ldquoImmunization Managerrdquo and ldquoVaccine Coordinatorrdquo fields in the
MnVFC Policies and Procedures Manual for their own referencebull The emergency plan in the manual can be reviewed from last year and included in this yearrsquos manual (with an updated signature and date) if there have not been any changes
bull If information in the plan is outdated site staff will not be well equipped to safely manage vaccines in the event of a power-outage or other emergency situation
bull If their institutional policy is only reviewed and updated every 3-4 years (as many are) the staff may need to sign the MnVFC Polices and Procedure Manual to meet this requirement
Resource Routine Vaccine Management Plan and Emergency Vaccine Management Plan in the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 29
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 37
3 Documentation VIS amp VAERS
Question 37 Review the providerrsquos Vaccine Information Statements (VISs) and discuss providerrsquos VAERS process toanswer the questions below
A Does the provider have readily available up-to-date VISs for all ACIP-recommendedvaccines relevant to the populations it serves
Yes No [X]
B Does the provider make a VIS available for patientsparents before eachvaccination
Yes No [X]
C Does the provider know how and when to report clinically significant adverseevents using VAERS
Yes No [X]
Review CDC Requirement
VFC providers are required to distribute the current Vaccine Information Statements (VIS) each time a vaccine is administered and maintain records in accordance with the National Childhood Vaccine Injury Act (NCVIA) which includes reporting clinicallysignificant adverse events to the Vaccine Adverse Event Reporting System (VAERS) For a list of current VISs visit CDCrsquos Vaccine Information Statements (httpwwwcdcgovvaccineshcpvis) website
Gal of this question Ensure the site has the most current VISs and is giving them to each patientparent before administering the vaccine in compliance with the federal law Parents must be educated about the vaccine their child will receive and be aware of possible contraindications and side-effects in order to make well-informed decisions about their childrsquos health
Helpful information bull Ask to see the sitersquos VISs to determine if they have an active protocol for giving VISs to parents Review to make sure they are current Ask if they know where and how to report vaccine adverse events
Resources bull Section 3 in the MnVFC Policies and Procedures Manual bull CDC Vaccine Information Statements (wwwcdcgovvaccineshcpvisindexhtml) Site may sign up for email updates for the current list of VIS publication dates for the most up-to-date version
bull IAC Itrsquos Federal Law You must give your patients current Vaccine Information Statements (wwwimmunizeorgcatgdp2027pdf)
bull VAERS (httpsvaershhsgovindex)
Question 38
3 Documentation Anaphylaxis protocol
Question 38 Does the site have an anaphylaxis protocol which is clearly posted near the emergency kit
Answers (Choose one)
Yes No [X]
Review CDC Requirement
An anaphylaxis protocol must be clearly posted in the area where vaccines are administered
Goal of this question Make sure site is prepared for a severe allergic or anaphylactic reaction to a vaccine
Resources bull Section 11 in the MnVFC Policies and Procedures Manual bull IAC protocols Child and Teens (wwwimmunizeorgcatgdp3082apdf) and Adults (wwwimmunize orgcatgdp3082pdf)
Page 30 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
i
i i i - li i i i i i l
Section 4 Storage amp Handling Per Unit The goal of this section is to assess vaccine storage
2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet practices in each unit at the site MnVFC PIN ___________________
The 2017 MnVFC Storage amp Handling Per Unit Answer Sheet is a worksheet to document the answers to the questions in this section for each unit (combination or stand-alone) Fill in the answers to the questions in Section 4 on the answer sheet not in the questionnaire
The answer sheet has an abbreviated form of each question If you need further information on that question refer back to the full questionnaire Also if you find an area where the site is not meeting the requirements you will need to go back to that question on the 2017 MnVFC Site Visit Questionnaire to complete ldquoActions if Non- compliantrdquo section including the root cause analysis and follow-up sections If there is a problem in more than one unit make a note on the questionnaire which unit you are referring to in the Notes section
Important You must fully assess any unit that may be used to store VFC vaccines even if there are no VFC vaccines there on the day of the visit If there are no vaccines and the site is not documenting twice a day temperatures discuss the need to ensure the unit is maintaining stable temperatures by monitoring for one week before placing vaccines in the unit
Quest on number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
for the freezer and e co umn
Temperature Monitoring Dev refr gerator f the un
ce Quest ons Quest ons 4 3 4 7 must be answered separate y t s a combo Be sure to document responses n the appropr at
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
44D Data downloaded and reviewed routinely (eg weekly)
Yes No [O]
Yes No [O]
45A Certificate of Calibration Testing Yes No [X]
Yes No [X]
45B Date of calibration
45C Date certificate expires [X] Follow-up is required if expired [X] Follow-up is required if expired
45D Certificate contains all necessary items
Yes No [X]
Yes No [X]
46 Probe properly placed Yes No [X]
Yes No [X]
47A Two temperature readings per day
Yes No [X]
Yes No [X]
47B Time date and name (or initials) for each reading
Yes No [X]
Yes No [X]
47C Current temperature and minmax temperatures (if
Current ________deg Minimum ________deg Maximum _deg
Current ________deg Minimum ________deg Maximum _deg
Sections 5 and 6 contain questions about storage and handling site wide and inventory It is helpful to keep those questions in mind as you assess the individual storage units Think about dorm-style units expired vaccine vaccine supply room for vaccine stocking all the recommended vaccines and separation of stock if appropriate
NOTE The sections that follow require reviewers to validate responses by looking at vaccine storage units temperaturemonitoring equipment and the vaccine inventory inside a unit bull For section 4 use a separate Storage amp Handling Per Unit Answer Sheet for each unit to document the findings (combination
units using both sections can be documented on the same answer sheet) bull When an unmet requirement is identified return to this questionnaire to complete the ldquoActions if Non-compliantrdquo section for
that question bull After you complete one answer sheet for each unit return to the questionnaire to complete sections 5 and 6 using information
you gathered while assessing the units The questions in sections 5 and 6 (Storage amp Handling Site-Wide and Inventory) are notunit-specific but do require that the response be based on a thorough assessment of all the providersrsquo units
4 Storage amp Handling Per Unit
Description On the Storage amp Handling Per Unit Answer Sheet place a name that will allow you or someone else from your program to easily identify this unit in the event of follow-up We recommend using Brand + Location(example Samsung - Room 123) Save each Storage amp Handling Per Unit Answer Sheet with the Brand + Location in the file name
(example SamsungRoom123doc)
IPI Advisor Manual | February 2017 Page 31
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 41
4 Storage amp Handling Per Unit Storage Unit Build amp Use
Question 41 Below select the build and use of the vaccine storage unit you are assessing
Note to Reviewer Dorm-style units Do not add dorm-style units here Dorm-style units will be addressed in section 5 Units storing only private stock You must review these storage units even if they contain only private stockat the time of the visit because that vaccine could be administered to VFC patients
A What type of unit is this A Stand-alone B Combination
B Select use if stand-alone A Freezer B Refrigerator
Select use if combination A Use both sections to store vaccine B Use freezer section only to store vaccine C Use refrigerator section only to store vaccine
Goal of this question Identify the unit you are evaluating The description asks you to create a unique name for this unit so that you will be able to identify the same unit in future site visits Put this description on the top of the answer sheet (ie make and location)
Helpful information bull A stand-alone unit is either a refrigerator or a freezer It does not have both sections in the unit bull If there is a combination unit note if the site uses both the refrigerator and freezer or only one section of the unit to store vaccines CDC does not recommend the use of either section or the freezer section only of combination household units
bull If your site utilizes the separate stock method of vaccine management you must review storage units even if they contain only private stock at the time of the visit because there is a chance that those vaccines could be administered (borrowed) to VFC-eligible patients
Page 32 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 424 Storage amp Handling Per Unit CDC Recommended Storage Units
Question 42 Below document the grade of the vaccine storage unit you are assessing
Note to Reviewer Pharmaceutical Also called ldquopurpose-builtrdquo these units are designed by the manufacturer specifically tostore vaccines or other biological materials Commercial Although usually intended to store food and beverages commercial units are often larger and more powerful than the household units found in most homes Though these units are intended to meet thehigher demands of larger facilities these units are not specifically built for the storage of biologicalmaterials Household (non-commercialdomestic) These units are usually smaller than commercial units and areintended for use in small offices and in homes ndash typically for food storage However just like commercialunits they are not designed specifically for the storage of biological materials Such units are usually available in common home supply stores
Answers (Choose one)
Select grade A Pharmaceutical B CommercialHousehold
[O] CDC does not recommend the use of both sections or the freezer section only of combination commercialhousehold units
Review CDC Recommendation
CDC recommends the following vaccine storage unit types (in order of preference) pharmaceutical grade stand-alone orcombination units (preferred) householdcommercial stand-alone units householdcommercial combination units using therefrigerator section only
Goal of this question Assess the grade and type of each storage unit bull Pharmaceutical grade units may be stand-alone or combination units that are often metal may have glass in the door for viewing inside often have an external digital temperature display and are manufactured by medical companies
bull Commercial or household units often look like your kitchen appliance have vegetablemeat drawers in the unit and are manufactured by household appliance companies
bull Occasionally you might find a medical grade unit which is usually a commercialhousehold unit with a lock and 3-prong plug These are still considered household units because of their ability to maintain proper temperatures and air flow Studies show that household stand-alone units are better able to maintain consistent temperatures than their combination counterparts Combination household units used to store vaccine in both sections of the unit is no longer recommended and may be prohibited in the future Combination household storage units that are having difficulty maintaining a cold enough freezer temperature and a warm enough refrigerator temperature should be replaced or a separate stand-alone freezer should be purchased
For frozen vaccines the most cost effective solution is for the site to purchase a small stand-alone freezer The site may need time to budget for a stand-alone storage unit
Resources bull Replacing Combination Household Units Tip Sheet on IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml)
IPI Advisor Manual | February 2017 Page 33
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 434 Storage amp Handling Per Unit Temperature Monitoring Device in the Unit
Question 43 Determine whether there is a temperature monitoring device in this section of the storage unit andanswer the questions
A Is there a temperature monitoring device in this section of thestorage unit
Yes No [X] (If no skip to question 47)
B Who is responsible for supplying the temperature monitoring device in this section of the storage unit Provider
Review CDC Requirement
Certificates of calibration testing provide confidence that the temperature monitoring device is measuring temperaturesaccurately All units storing VFC vaccines must have a calibrated temperature monitoring device with a current and valid certificateof calibration testing All certificates must contain modeldevice name or number serial number date of calibration testing (report or issue date) and Instrument Passed testingInstrument in Tolerance (Recommended uncertainty = +-05ordm C (+-1ordm F))
Goal of this question Assess whether there is a temperature monitoring device in the unit If the unit is not being monitored at all call MDH at 651-201-5522 for guidance
Helpful information bull This question does not ask whether the temperature monitoring device is working or the characteristics of the device These issues will be addressed later in the questionnaire
bull For part B the provider is always responsible for supplying the temperature monitoring device Even if their thermometer or data logger was originally from MDH it is their responsibility to ensure it is functional and calibrated
Resources bull Section 8 in the MnVFC Policies and Procedures Manual
Page 34 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 444 Storage amp Handling Per Unit CDC Recommended Temperature Monitoring Device
Question 44 Assess the temperature monitoring device in this section of the storage unit to answer the questionsbelow
A Is the temperature monitoring device a continuous monitoring and recordingdevice (eg data logger)
Yes No [O] (Skip D)
B Does the temperature monitoring device have a probe in buffered material Yes No [O]
C Does the temperature monitoring device have a digital display that can beeasily read from the outside of this unit
Yes No [O]
D Is data downloaded and reviewed routinely Yes No [O]
Review CDC Recommendation
As of Jan 1 2018 all VFC providers must use continuous temperature monitoring devices (eg data loggers) to monitor vaccinesthat will be administered to VFC-eligible children Routine review and accessibility of temperature data is critical for determining whether vaccine has been properly stored and for assessing usability of vaccine that was involved in a temperature excursion Tomeet VFC Program requirements the device must also be equipped with bull A temperature probe bull An active temperature display that can be easily read from the outside of the unit bull The capacity for continuous monitoring and recording capabilities where the data can be routinely downloaded
The following are additional recommended features for these devices bull Alarm for out-of-range temperatures bull Current minimum and maximum temperatures display bull Low battery indicator bull Accuracy of +- 1degF (05degC) bull Memory storage of at least 4000 readings bull User programmable logging interval (or reading rate) recommended at a maximum time interval of every 30 minutes bull Use of a probe that best reflects the temperature of the vaccine (such as a buffered probe)
Goal of this question Assess the temperature monitoring device in the storage unit Note that these are all recommendations not requirements at this time
This is a great teaching opportunity for sites who do not currently have a continuous temperature monitoring device Beginning Jan 1 2018 all units that store MnVFC vaccine will be required to have a continuous temperature monitoring device (ie a data logger or a continuous temperature monitoring system) Unlike a minmax thermometer a continuous temperature monitoring device provides detailed information on all temperatures recorded at pre-set intervals For excursions it can provide information on when a temperature went out-of-range for how long and what the temperatures were This is essential information that vaccine manufacturers need to know to assess the viability of the vaccine following an excursion
Helpful information bull Sites are required to monitor and record temperatures twice daily however temperature excursions can easily occur in the 12 hours or longer between readings Continuous temperature monitoring can help manufacturers determine vaccine viability
bull Continue to encourage sites to document and evaluate minimum and maximum temperatures the storage unit reached since the last reading and respond appropriately to out-of-range temperatures
IPI Advisor Manual | February 2017 Page 35
The 2017 MnVFC Site Visit Paperwork Chapter 4
bull It is recommended that sites download and review data weekly Discuss with sites that reviewing temperature monitoring device data also includes responding appropriately if they identify out-of-range temps
bull There is sometimes confusion about the difference between a data logger and a continuous temperature monitoring system Here are some differences
Data Loggers Continuous Monitoring Systems Have an external display similar to thermometers May or may not have an external display Have a detachable probe Probe is usually attached to transmitter Need to be plugged into the computer or cradle to download information on a regular schedule
Wirelessly sends data to computer system
Create a file of data that needs to be saved on the computer
Data is stored within the system not a separate file
Doesnrsquot allow documentation of twice a day temperature checks in the file
May allow documentation of twice a day temperature checks within the system
More about the 2018 requirement for a continuous temperature monitoring device
Required Features bull The continuous temperature monitoring device must have Continuous monitoring and recording capabilities to track and record temperatures over time The capacity to routinely download temperature data to a computer (recommended at least weekly) or wirelessly transmit data Detachable probe in a bottle filled with a thermal buffer (eg bio-safe glycol) if the data logger needs to be detached in order to download data Active temperature display
Recommended Features bull MnVFC recommends continuous temperature monitoring devices with Alarm for out-of-range temperatures Accuracy within +-1degF (+- 05degC) Low battery indicator Display of current minimum and maximum temperatures Memory storage of at least 4000 readings User programmable logging intervals (eg the user can set how often the device records the temperature)
Note that these are all currently recommendations not requirements yet
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Page 36 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 45
Goal of this question Ensure the temperature monitoring device is properly calibrated The certificate of calibration testing means that the device has been tested and it is accurately measuring temperatures within established testing limits The certificate of calibration ensures that the device meets all the required components
Helpful information bull The provider is always responsible for having a current certificate of calibration (or copy) on-site
bull To be considered ldquovalidrdquo a certificate of calibration must contain these required elements Modeldevice name or number Serial number
4 Storage amp Handling Per Unit Certificate of Calibration Testing
Review CDC Requirement
Certificates of calibration testing provide confidence that the temperature monitoring device is measuring temperaturesaccurately All units storing VFC vaccines must have a calibrated temperature monitoring device with a current and valid certificateof calibration testing All certificates must contain modeldevice name or number serial number date of calibration testing (report or issue date) and Instrument Passed testingInstrument in Tolerance (Recommended uncertainty = +-05ordm C (+-1ordm F))
Question 45
Note to Reviewer
A
B
C
D
E
Review the certificate of calibration testing for the temperature monitoring device in this section of the storage unit and answer the questions below
bull How to determine certificate of calibration testing expiration date 1) Identify the certificate issuecalibration date 2) Apply the Immunization Program-required frequency for calibration testing Example If the
issuecalibration date is 12312013 and Immunization Program policy requires testing every twoyears the expiration date is 12312015
bull Certificates must include all of the below bull ModelDevice Name or Number bull Serial Number bull Date of Calibration Testing (Report or Issue Date) bull Instrument Passed testing (Instrument in Tolerance)
Is there a certificate of calibration testing for the temperature monitoring Yes device in this section of the storage unit No [X]
What is the date of calibration for the temperature monitoring device in this section of the storage unit
What is the certificatersquos date of expiration based on ImmunizationProgram policy (See note to reviewer to determine expiration date) [X] Follow-up is required if
certificate is expired
Does the certificate contain all the necessary items listed in the Note to Yes Reviewer No [X]
Who is responsible for supplying the current and valid certificate of Provider calibration for this temperature monitoring device
Date of calibration testing (report or issue date) Note If there is no expiration date the certificate expires 2 years from the date of calibration Whether the instrument passed or failed testing (or instrument in tolerancenot in tolerance)
bull Recommended element Documented uncertainty of +- 1degF [05degC]
If these elements are present the certificate is considered valid If the certificate contains information about the recommended element or the entity that issued the certificate that is helpful but not required
To determine if a certificate of calibration testing was issued by an appropriate entity check to see if the certificate indicates one or more of these items (this is the wording used to help sites evaluate if their calibration is accurate but is not required on the certificate itself to be considered valid)
bull Conforms to ISO 17025 bull Performed by an ILACMRA Signatory body accredited laboratory You can review this list of the ILAC MRA and Signatories (httpilacorgilac-mra-and-signatories)
bull Traceable to the standards maintained by NIST bull Meets specifications and testing requirements for the American Society for Testing and Materials (ASTM) Standard E2877 tolerance Class F (le 05 degC) or better
bull Includes reference to another acceptable accuracy validation method such as comparison to other traceable reference standards or tests at thermometric fixed points
Note CDC recommends that certifications be issued for the entire monitoring unit (detachable probe data logger etc) and not individual certificates for each component
IPI Advisor Manual | February 2017 Page 37
The 2017 MnVFC Site Visit Paperwork Chapter 4
For 45 E the provider is always responsible for supplying the current and valid certificate of calibration for a temperature monitoring device
bull Tip If the temperature monitoring device has a sticker on the back with the calibration date the site can usually call the company who calibrated the device and get a copy of the certificate if they donrsquot have one
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 46 4 Storage amp Handling Per Unit Probe Placement
Question 46 Is the probe properly placed in this section of the storage unit
Note to Reviewer ldquoProperlyrdquo means that the probe in a commercial or household unit is placed in a central area of the unitdirectly with the vaccines Probes should not be placed in the doors near or against the walls close to vents or on the floor of the unit The only allowable exemption related to this requirement is for providerswho have pharmaceutical storage units (built for vaccine storage) that have either (1) a built-intemperature monitoring device OR (2) a dedicated port for the probe that dictates the placement of theprobe
Answers (Choose one)
Yes No [X]
Review CDC Requirement
The probe must be placed in a central area of the section of the storage unit directly with the vaccines in order to properly measurevaccine temperature The probe should not be placed in the door near or against the walls close to vents or on the floor of theunit For pharmaceutical units with a built-in temperature monitoring device or a dedicated port for a probe that is not in thecenter of the section of the storage unit consult your Immunization Program for guidance on placement
Goal of this question Make sure the temperature monitoring device is in the best location to accurately measure the temperature of the vaccines stored in the unit
Helpful information bull The probe of the temperature monitoring device should be placed directly with the vaccines in the middle of the unit The ONLY allowable exception is for pharmaceutical storage units that have either a built-in thermometer or a dedicated port for the probe that indicates placement of the probe
bull Temperatures can vary within the unit especially household units bull Call MDH at 651-201-5522 if you have questions
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Guide (wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml)
Page 38 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 474 Storage amp Handling Per Unit Temperature Documentation
Question 47 Review the temperature documentation over the past three months for this section of the storage unit todetermine whether the provider has a process in place for properly documenting temperatures twice aday Answer the questions below
A Are there two temperature readings recorded for this section of the storage unit per day
Yes No [X]
B Is there a time date and name (or initials) recorded for each reading Yes No [X]
C What is the current temperature and minmax temperatures (if available) inthis section of the storage unit Use the reviewerrsquos thermometer if the providerrsquos temperature monitoringdevice does not have a current valid certificate of calibration testing or the probe is not properly placed in this section of the storage unit
Current Temperature Minimum Temperature Maximum Temperature Fahrenheit Celsius
D Based on your review of the providerrsquos recent temperature documentationincluding the current temperature is this section of the storage unitmaintaining appropriate temperatures
Yes No [X] Not enough information [X]
Review CDC Requirement
Vaccines must be stored under appropriate temperatures as described in the package inserts at all times Acceptable temperature ranges vary by vaccine type and the range is 36deg F and 46deg F (2deg C and 8deg C) and for frozen vaccines the range is -58deg F and +5deg F (shy50deg C and -15deg C) Exposure to temperatures outside of those included in the package inserts could affect vaccine viability andultimately could leave children unprotected against vaccine-preventable diseases In order to maintain awareness of storage unittemperatures and ensure that vaccines are being stored at appropriate temperatures at all times VFC providers are required to monitor and document temperatures for all vaccine storage units at least twice a day Temperature documentation must contain (1) at least two temperature readings per day (2) the time and date of each reading and (3) the name (or initials) of the personwho assessed and recorded the readings CDC also recommends that VFC providers record the minimum and maximumtemperatures of each unit once each workday (preferably in the morning)
Goal of this question Ensure the temperature is being monitored twice daily is within the required range and documented correctly Use your thermometer to check the temperature if the sitersquos temperature monitoring devicersquos probe is not properly placed or there is not a current certificate of calibration Place your thermometer in the unit at the beginning of the visit to allow sufficient time to reach an accurate temperature The purpose of using your thermometer is to ensure the vaccine is being stored at the proper temperature not to ldquovalidaterdquo their reading
Question 47 D is an assessment question based on information you have learned during your visit You might answer ldquonot enough informationrdquo if the unit is new and they donrsquot have at least three months of data or if the unit is only used as overflow and they are inconsistent with temperature monitoring Mark ldquoNordquo if you have reason to believe the storage unit is not maintaining temperatures properly
Helpful information bull All sites must document temperatures twice a day every day the site is open even if they have a data logger or continuous monitoring system
bull Sites can document the information electronically with some continuous monitoring systems as long as it can show what the current temp is the date time and initials of the person checking ndash this needs to be someone at the site ndash not checking remotely or centrally for a large site or system The site must be able to produce these records during their site visit Reviewing these files can be a challenge due to large volumes and lots of paper
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Temperature Logs on Managing Vaccine (wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml)
IPI Advisor Manual | February 2017 Page 39
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 484 Storage amp Handling Per Unit Temperature Excursions
Question 48 In the event that a temperature excursion(s) occurred in this unit within the last three months requestand review documentation of actions taken to determine whether the provider has a process for properlyaddressing excursions Answer the questions below
A Were vaccines in this unit exposed to out-of-range temperatures in the lastthree months (including today)
Yes No (If no skip to question 49)
B Did the provider quarantine and label vaccines as ldquoDo not userdquo Yes No [X]
C Did the provider place vaccine in a unit where it can be stored under properconditions if applicable
Yes No [X]
D Did the provider contact the Immunization Program to report theexcursion
Yes No [X]
E Was the manufacturer contacted for documentation supporting theusability of the vaccine
Yes No [X]
Review CDC Requirement
The provider must document all excursions and actions taken including the following (1) Quarantine and label vaccines as ldquoDO NOTUSErdquo (2) Place vaccines in a unit where they can be stored under proper conditions (3) Contact the Immunization Program to report an excursion and (4) Contact the vaccine manufacturer to obtain documentation supporting the usability of the vaccine
Goal of this question Address any out-of-range temperatures (temperature excursions) identified in reviewing the last three months of temperature logs or during the site visit If there were any out-of-range temperatures did the site respond appropriately to the situation This is a great opportunity to discuss what to do in the event of an excursion The Clinicians Storage and Handling Mishap Checklist is in the IPI Site Visit information folder and is a good review of the process
Helpful information bull Sites need to know that an excursion does not automatically mean that exposed vaccines are non-viable or unusable Exposed vaccines must be quarantined (marked ldquoDo Not Userdquo) and stored under proper conditions until they have received information from vaccine manufacturers regarding the viability of the vaccine
bull Sites must inform MDH when an excursion occurs
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Clinicians Storage and Handling Mishap Checklist (wwwhealthstatemnusdivsidepcimmunize ipivaxchklstpdf)
Page 40 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 49
Goal of this question Ensure proper placement of vaccines in the storage unit
Note These are all recommendations (best practices) not requirements
Helpful information bull Store vaccine in the middle of the compartment two to three inches away from the coils walls floor and cold air vent The temperature near the floor and walls of the unit differs from that in the middle of the compartment and the cold air vent can freeze refrigerated vaccines
4 Storage amp Handling Per Unit Vaccine Placement
Question 49 Look inside the unit to answer the questions below
A Are vaccines placed in the middle of the unit with space between vaccinesand the sideback of the unit to allow cold air to circulate
Yes No [O]
B Are vaccines stored in their original packages Yes No [O]
C Are there water bottles (for refrigerators) or frozen water bottles (forfreezers) in the unit
Yes No [O]
D Are vaccines store in the doors vegetable bins under or near cooling ventsor on the floor of the unit
Yes [O] No
E Is food being stored in the unit Yes [O] No
Review CDC Recommendation
Vaccines should be stored in their original manufacturer (or CDC centralized distributor) packaging They should be placed in the middle of the unit with space between the vaccines and the sideback of the unit to allow cold air to circulate Vaccines SHOULD NOT be stored in the doors vegetable bins or floor of the unit or under or near cooling vents and there should not be any food inthe unit Water bottles (for refrigerators) or frozen water bottles (for freezers) should be placed throughout each storage unit inorder to (1) stabilize or extend temperatures during a power outage and (2) to serve as physical blocks preventing the placementof vaccines in areas of the unit that are at higher risk for temperature excursions (such as in doors vegetable bins floor ornearunder cooling vents)
bull Vaccines should be kept in their original packaging to Protect them from light Help prevent medication errors by making labels easier to read Provide a moisture barrier that serves as insulation in case of an out-of-range temperature power outage door left open or mechanical failure Simplify managing vaccine inventory
bull Store water bottles in the doors on the floor and near the cold air vent in the refrigerator and frozen water bottles in the freezer to help maintain a stable temperature if there is a power failure and when the door is opened frequently Too many water bottles in the door can prevent the door from closing tightly Mark water bottles ldquoDo Not Drinkrdquo
bull Do not store vaccine in the door or drawers of the refrigerator or freezer Vegetable bins and crisper drawers should be removed from refrigerators or used to store other medical supplies or water bottles
bull If vaccine is stored in a household combination refrigeratorfreezer The top shelf should not be used for storing vaccine because the cold air vent blowing from the freezer will freeze vaccine located there If you must use the top shelf of this type of unit place water bottles underneath the cold air vent to prevent vaccine from being stored there It is recommended that only the refrigerator be used for vaccine storage and a separate stand-alone freezer be used to store frozen vaccine
bull Must not store food or beverages in the refrigerator or freezer because frequent opening of doors can lead to temperature variations that may affect vaccine viability There is also a risk of contaminating vaccines
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Guide (wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml) bull Vaccine Storage Tip Sheet on IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml)
IPI Advisor Manual | February 2017 Page 41
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 4104 Storage amp Handling Per Unit Disconnection from Power Source
Question 410 Ask the provider to demonstrate what measures are taken to ensure that vaccine storage units are notaccidentally physically disconnected from the power supply Which of the following describes the measure(s) taken on this unit
Note to Reviewer bull Large hospitals and healthcare systems may not have the ability to demonstrate labels on plugs or circuitbreakers In such cases verify that the practice has a comprehensive policy and standard operatingprocedures in place to prevent the vaccine storage unit from being physically disconnected from thepower supply
bull While back-up generators may ensure power to the overall facility this question ONLY addresses thevaccine storage unit being accidentally disconnected from the power source either through the plug orthe circuit breaker
Answers A ldquoDo not disconnectrdquo labels on the plug (Choose all that B ldquoWarningrdquo label on the circuit breaker box
apply) C Hard-wired (ie built-in) and has a ldquoDo not disconnectrdquo label on thecircuit breaker box D Hospital or large health care system with a comprehensive written policyand standard operating procedures detailing measures taken to preventvaccine storage units from being accidentally disconnected from the powersupply E No acceptable measures for preventing accidental disconnection frompower supply [X]
[X] The response is non-compliant if only A only B or E is selected
Review CDC Requirement
VFC providers must take steps to protect the power source for all vaccine storage equipment by means of having clear warninglabels on both the plug and the circuit breaker associated with all vaccine storage units Large hospitals and healthcare systems canmeet this requirement by demonstrating that they have comprehensive policies and standard operating procedures to preventvaccine storage units from being physically disconnected from the power supply
Goal of this question Decrease the chance that a vaccine storage unit will be accidently unplugged or power will be turned off while vaccine is in the unit This question addresses only what measures the site has taken to ensure the storage unit is not physically disconnected from its power source
If the site uses labels on the plugs and circuit breakers perform a visual inspection to assess whether the way the stickers are positioned make it clear and obvious to anyone that these units are not to be disconnected
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Do Not Unplug and Warning stickers are included in the folder or available to order on the For
Professionals Order Form (wwwhealthstatemnusdivsidepcimmunizeordermathtml)
Note Once you have completed the 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet for each unit return to the questionnaire to complete sections 5 and 6
Page 42 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
- -
Section 5 Storage amp Handling Site-Wide Question 51
5 Storage amp Handling Site Wide Discussion of Cost amp Quantity of Vaccine
Question 51 Have a discussion with the provider about the cost and quantity of VFC vaccines they are responsible for annually Address the points listed in the note to reviewer below
Note to Reviewer bull Vaccine Shipped (Required) Share the cost of VFC vaccines shipped to the provider in the last calendaryear to make sure the provider understands the contribution made by the VFC Program to their practiceFor new providers who do not have ldquocalendar yearrdquo data share either the actual cost of their currentinventory or use the cost of 10 VFC doses of each of the ACIP-recommended vaccines (approximately $7000) to help estimate their annual cost
bull Storage amp Handling (Required) Make sure the provider understands the cost of vaccines for which they are responsible when they make decisions about purchasing recommended vaccine storage and temperature monitoring equipment
Answer I have discussed with the provider the cost and quantity of vaccines ordered in the previous calendar year
Goal of this question Inform sites of the quantity and value of vaccines that they receive as part of the MnVFC program Providers often donrsquot realize the value of the vaccine in their unit This information is included on your clinic list and on the one page site-specific information
Helpful information bull This discussion must occur and the box on the questionnaire must be checked bull If there isnrsquot actual vaccine value information available tell the site that one vaccine order that includes a box of each of the ACIP recommended vaccines costs approximately $7000
bull MDH may not have specific information for individual sites if they receive vaccine from a central warehouse or pharmacy For those sites MDH will give you numbers for the whole system so you can discuss system wide data as appropriate If individual site information is also included it is usually just varicella-containing vaccines that must be shipped directly to the site
Question 52
5 Storage amp Handling Site Wide Dorm Style Units
Question 52 Determine whether the provider has any dorm-style units on site and answer the questions below
Note to Reviewer A dormitory-style refrigerator is a unit that has both refrigerator and freezer compartments behind a singleexterior door Dorm-style units also have an evaporator plate (cooling coil) which is usually located insidean icemaker compartment (freezer) within the refrigerator
A Does the provider have any dorm-style units that are used at any time tostore vaccines
Yes [X] No (Skip to question 53)
B Does the provider have sufficient space in existing compliant vaccinestorage units to store all vaccines without use of the dorm-style unit at any time
Yes No [X]
Review CDC Requirement
Dorm- and bar-style units are prohibited for vaccine storage Vaccines stored in dorm-style units are considered non-viable and must be returned to the centralized distributor CDC recommends the following vaccine storage unit types (in order of preference)pharmaceutical grade stand-alone or combination units (preferred) householdcommercial stand-alone unitshouseholdcommercial combination units using the refrigerator section only
Goal of this question Ensure no vaccine is stored in dorm-style units even for short periods of time Encourage them to label any units ldquoNo Vaccine Storage Allowedrdquo Vaccine stored in these units is considered non-viable If a site is using a dorm-style unit call the MnVFC program (651-201-5522)
Resource Section 8 in the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 43
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 535 Storage amp Handling Site Wide Storage Unit Space Availability
Question 53 Does the provider have sufficient room across storage units to store current stock as well as anyadditional stock acquired during peak season without overcrowding
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have sufficient storage space to accommodate vaccine stock at the busiest time of year without overcrowding
Goal of this question Ensure that sites have sufficient space in their units to maintain vaccines at the busiest time of year Overcrowding of vaccine limits air circulation and affects the unitrsquos ability to maintain stable temperatures
Helpful information bull Look for signs of overcrowding such as vaccines that are pushed up against the wall bins that are overflowing or storage units that are full during non-peak seasons
Discuss immediate actions if the unit is overcrowded Move some of their vaccines order less vaccine more frequently (once per month preferably) andor purchase another storage unit for overflow
Resource bull Section 8 MnVFC Policy and Procedure Manual
Page 44 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 545 Storage amp Handling Site Wide Expired Vaccines
Question 54 Look in each unit Are there expired vaccines in any of the vaccine storage units at this site
Answers (Choose one)
Yes [X] No
Review CDC Requirement
Vaccines should be rotated weekly and when a new shipment comes in so that longer-dated vaccines are stored behind shorter-dated vaccines If vaccines expire they can no longer be stored in the same storage unit with viable vaccines They must be placedin a container or bag clearly labeled ldquoDo not userdquo and separated from viable vaccines to prevent inadvertent use Expired vaccinemust be returned to the centralized distributor within six months of expiration
Goal of this question Ensure there is no expired vaccine in any storage unit
Helpful information bull Sites can prevent their stock from expiring by rotating vaccines every week andor when a new shipment arrives Longer-dated vaccines are stored towards the back of the unit and shorter-dated vaccines are up front
bull Pay attention to vaccines that expire within the next three months Consider transferring vaccine that will expire soon to another MnVFC-enrolled site that will use the vaccine preferably a site close by It is the transferring sitersquos responsibility to arrange the transfer of the vaccine Be sure to complete the MDH Vaccine Transfer Record form and send it to MDH If they are having difficulty finding a location to accept vaccine contact MDH
bull This is a great opportunity to educate sites about the MDH Nonviable Vaccine Form and the process for returning vaccine The VFC program does get some credit for taxes and fees on vaccine that is returned to the distribution center
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MDH Nonviable Vaccine Form and MDH Vaccine Transfer Record on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfcformshtml)
IPI Advisor Manual | February 2017 Page 45
The 2017 MnVFC Site Visit Paperwork Chapter 4
- -
-
Question 555 Storage amp Handling Site Wide Back up Thermometer
Question 55 Does the provider have a readily available back-up thermometer with a current and valid certificate ofcalibration testing
Note to Reviewer ldquoReadily availablerdquo means that the thermometer is available to perform twice-a-day monitoring for a unit asrequired CDC recommends that the back-up thermometer be maintained on site
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have a readily available back-up thermometer with a current and valid certificate of calibration testing Toprevent the certificates of calibration testing of the primary and back-up thermometers from expiring at the same time the date of calibration testing (or issue date) of the back-up thermometer should be different from the date of calibration testing (or issue date) of the primary thermometer As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meetsVFC program requirements
Goal of this question Ensure sites have one calibrated back-up thermometer onsite that is readily available in the event that the temperature monitoring device in unit fails transportation of vaccine is needed or there are other unexpected circumstances
Helpful information bull As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meets VFC Program requirements
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 56 5 Storage amp Handling Site Wide Preparation of Vaccine
Question 56 When does this provider prepare vaccine for administration to the patient
Note to Reviewer For mass vaccination clinics if one type of vaccine is offered providers may pre-draw up to 10 doses Ifusing pre-filled syringes pre-drawing also means activating the syringe by removing the needle guard orattaching a needle
Answers (Choose all that
apply)
Prepare dose immediately before administration Pre-draw doses for upcoming patients (in a regular clinicpractice) [O] Pre-draw up to 10 doses (in a mass-vaccination clinic) Pre-draw more than 10 doses (in a mass-vaccination clinic) [O] Other [O]
Review CDC Recommendation
CDC recommends preparing vaccines immediately prior to administration in order to assure viability of vaccine and prevent vaccinewastage Vaccines that are not administered immediately are at risk of exposure to temperatures outside of the required rangewhich can affect vaccine viability and ultimately can leave children unprotected against vaccine-preventable diseases
Goal of this question Discuss proper timing and preparation of vaccine(s) for administration These are recommendations not requirements
Helpful information bull Educate staff on the importance of preparing vaccine immediately before administration Pre-drawing of vaccines may lead to concerns related to vaccine viability potency sterility and wastage
Page 46 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 6 Inventory Question 61
6 Inventory Inventory Comparison
Question 61 Visually inspect storage units to determine if existing supply of vaccines proportionately mirrorspopulations served Choose the most accurate statement below
Note to Reviewer bull CDC recommends that providers maintain a four-week supply of inventory bull For this question do not take into account vaccine types that the provider does not order Here simply
make sure that overall the vaccines in the providerrsquos storage units are available in sufficient amounts toserve their patient population
Answers (Choose one)
The current vaccine inventory proportionately reflects the populations identified Only public stock is insufficient [X] Only private stock is insufficient [X] Both public and private stock are insufficient [X] Site uses the replacement method but does not appear to have enough vaccine for their population [X] Other [X]
Review CDC Requirement
VFC providers must order and stock routine vaccines in accordance with their patient population in order to prevent missedvaccination opportunities Having sufficient amounts of all stocks prevents the inadvertent use of VFC vaccines for non-VFC-eligiblepatients and vice versa
Goal of this question Assess whether the site is ordering appropriate quantities of vaccine for the population they serve at their site
Helpful information bull If the site sees 30 percent private-pay patients and 70 percent VFC the stock in their storage units should reflect that proportion If you donrsquot know you can ask the site about their population
bull This is meant to be a general assessment so in a big site if they have only a small amount of vaccine that may indicate an issue with vaccine management
bull CDC recommends smaller more frequent orders (ie monthly) rather than large orders to minimize the amount of vaccine loss if an incident occurs during shipment or in the storage unit Sites should not order more frequently than once a month
bull Sites using the replacement method will only have one stock but it should appear to be large enough for their population
bull Only assess the vaccine types that the site currently stocks in their unit We know there are sites that do not offer all ACIP-recommended vaccines for various reasons That issue will be addressed in question 62
IPI Advisor Manual | February 2017 Page 47
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 626 Inventory ACIP Recommended Vaccines
Question 62 Review providerrsquos current inventory to answer the questions below
A Does the provider offer all routine ACIP-recommendedvaccines for their patient population
Yes (Skip to question C) No [X] Offers all except varicella because direct ship ofvaccine is unavailable from manufacturer
B Which routine vaccines are NOT being offered DTaP Hepatitis A Hepatitis B HIB HPV Influenza Meningococcal
MMR Pneumococcal Polio Rotavirus TdapTd Varicella
C According to Immunization Program Policy does theprovider make accessible all non-routine ACIP-recommended vaccines for those VFC patients whomeet the criteria for receiving them
Yes (Skip to question 63) No [X]
D Which non-routine vaccines are NOT being offered Pneumococcal polysaccharide vaccine (PPSV23) Meningococcal Group B (MenB) Other
Review CDC Requirement
VFC providers agree to comply with immunization schedules dosages and contraindications that are established by the Advisory Committee on Immunization Practices (ACIP) for the vaccines identified and agreed upon in the Provider Agreement UNLESS bull In the VFC providers medical judgment and in accordance with accepted medical practice the VFC provider deems such
compliance to be medically inappropriate for the child bull The particular requirements contradict state law including laws pertaining to religious and other exemptions The VFC program entitles children to the following vaccines DTaP Hepatitis A Hepatitis B HIB HPV Influenza MeningococcalMMR Pneumococcal Polio Rotavirus TdapTd and Varicella VFC providers are also required to ensure that VFC-eligible children have access to non-routine vaccines as needed
Goal of this question Assess if the site is offering all the ACIP-recommended vaccines for the population they serve and these vaccines are in stock on the day of the visit It is important that every MnVFC-eligible child that comes to a providerrsquos office for an immunization is vaccinated
Helpful information bull The Advisory Committee on Immunization Practices (ACIP) is a group of medical and public health experts that develops recommendations on how to use vaccines to control diseases in the United States
bull Specialty providers are not required to offer all routine vaccines but should provide the vaccines appropriate for their population
bull If the site does not offer all routine ACIP-recommended vaccines appropriate for their population check the ldquoNordquo box in Part A then check the appropriate box(es) in Part B for any vaccines not offered Please contact MDH as this situation offers us the opportunity to provide education to the site
bull For non-routine vaccines they must either be in stock or the site must have an alternative protocol in the routine management plan that ensures these children have access when applicable
Resources bull IAC Diseases and Vaccines (wwwimmunizeorgvaccines) bull CDC Advisory Committee on Immunization Practices (ACIP) (wwwcdcgovvaccinesacipindexhtml)
Page 48 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 636 Inventory Separation of Stock
Question 63 Observe how the provider differentiates stock in each storage unit to answer the questions below
A Is it clear which vaccines belong to public stock andwhich belong to private stock
Yes No [X] Not applicable replacement site
B Is it clear which vaccines belong to VFC stock andwhich belong to UUAV stock
Yes No [X] Not applicable replacement site Not applicable not UUAV-enrolled site
Review CDC Requirement
In order to ensure that VFC vaccines are only administered to VFC-eligible children VFC providers that serve both VFC and non-VFCshyeligible children must maintain their vaccine inventories in such a way that they can clearly differentiate public stock from privatestock as well as VFC from other public stock
Goal of this question Assess whether the site can distinguish between MnVFC vaccine and private vaccine If they participate in the Uninsured and Underinsured Adult Vaccine (UUAV) program they should also be able to distinguish between MnVFC stock and UUAV stock Some sites use labels bins boxes etc to differentiate their stock If it is not clear how the site differentiates their stock discuss vaccine management with the staff For follow-up call MDH to discuss doing a follow-up site visit
Sites using the replacement method will not have separate stocksmdashthis is an approved alternative method for keeping track of vaccine
Resource bull Section 10 of the MnVFC Policy and Procedure Manual
IPI Advisor Manual | February 2017 Page 49
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
MnVFC Site Visit Storage and Handling Per Unit Answer Sheet 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet MnVFC PIN ___________________
Question number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
Temperature Monitoring Device Questions Questions 43 47 must be answered separately for the freezer and refrigerator if the unit is a combo Be sure to document responses in the appropriate column
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
All the questions on the Site Visit Storage amp Handling Per Unit Answer Sheet have been discussed previously in section 4 of this manual Use this sheet to record information about all the units at the site visit You will need one sheet for each unit If it is a combination unit (either pharmaceutical or household) you can record both sections on one sheet If they have stand-alone units use one sheet for each unit Do not enter the answers to the questions in section 4 of the questionnaire
If you need more information about any of the questions refer back to the main questionnairemdashthe complete question additional guidance including notes to the reviewer and the CDC requirements are there Also if the site is not meeting the requirement you will go back to the questionnaire to complete the ldquoActions if Non-compliantrdquo section including the root cause analysis and follow-up sections
When you have completed the assessment of all the storage units remember to go back to the questionnaire to complete sections 5 and 6
Page 50 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
ndash
ndash
MnVFC Provider Follow-up PlanThe goal of the Provider Follow-up Plan is to communicate with the site all of the VFC requirements any unmet requirements found during your site visit and the timeline for completing the required action The left hand column is a box to check for ldquoUnmetrdquo requirements
Helpful information bull The form can be used to review what the site is doing well and what they need to work on
bull For requirements that have specific documentation that needs to be sent to you use the notes section
2017 MnVFC Provider Follow-up Plan Site _______________________________________________ MnVFC PIN ____________ Date of Visit ___________
Thank you for participating in this MnVFC compliance site visit Please review this visit summary including follow-up actions and timelines for completion Unmet MnVFC requirements and recommendations have a checked box next to them The goal of this plan is to support you with successfully implementing the program and improving access to vaccines for VFC-eligible children
Unmet Question VFC Requirements Section 1 Changes to Key Staff
Q12 Change in the Medical Director Immunization Manager Vaccine Coordinator or back-upKey Staff must be communicated to the immunization program by emailing healthmnvfcstatemnus Changes Notes
Q12 Key staff must complete the annual training on VFC program requirements and print theAnnual Training certificate of completion Documentation Required Action
Staff that have not completed the MnVFC online training must complete it and send acopy of the certificate to the reviewer Training can be found on the MnVFC website (wwwhealthstatemnusvfc) Due date 1 month
Notes
Unmet Question VFC Requirements Section 2 Eligibility
Q21 Provider staff must possess a working knowledge of all VFC eligibility criteria and use thoseVFC Eligibility criteria to screen children prior to administering VFC vaccines
Categories Notes
bull This form provides documentation needed for follow-up actions when you send your thank you email
The second to last page of the Provider Follow-up Plan has a summary of the MnVFC program recommendations These are to remind the site about best practices they may want to improve upon even though they are not yet requirements of the program For example you could discuss the recommendation about storage units if they currently have a combination household unit and are using both sections
The last section is for your signature and the person you met with In most sites it will be the immunization manager or vaccine coordinator who signs the form unless the medical director attended the site visit You keep the original copy and the site will need to keep a copy for themselves
To be completed by the site visit reviewer
I acknowledge that a VFC site visit was performed on __________________ (visit date) The follow-up plan which includes a list of all current VFC program requirements and recommendations assessed during the visit and any required follow-up actions was provided at the end of the visit
Site visit reviewer
Phone
Reviewer Signature Date
To be completed by the provider
I acknowledge that our practice took part in the VFC site visit noted above I understand the findings of the visit and any required actions that must be taken by our office in order to meet VFC program requirements
Medical Director (or designee) Name Title
Medical Director (or designee) Signature Date
IPI Advisor Manual | February 2017 Page 51
The 2017 MnVFC Site Visit Paperwork Chapter 4
After the Site Visit Send a thank you email highlighting the unmet requirements documents you need from the site to resolve the issue(s) and the date you need them Make sure to include the link to the Site Visit Survey (httpssurveyvovicicomseashxs=56206EE334CE0B14)
Please refer to Chapter 3 for more information about future follow-up required after the visit including forms and documentation
Resource bull Sample Thank You letter on IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml)
Chapter 5
IPI Advisor Resource List MnVFC Program 651-201-5522
MnVFC wwwhealthstatemnusvfc
bull Separate Stock and Replacement Method Policies and Procedures Manuals bull Online trainings bull MnVFC Announcements sign up to receive them via email bull Ordering MDH vaccine bull MnVFC forms Screening forms Reporting forms Others MDH Nonviable Vaccine Form MDH Vaccine Transfer Record and Vaccine Borrowing Report
bull MnVFC promotional materials bull Immunization Billing Guidance for MnVFC and Immunization Billing Guidance for MnVFC Replacement Sites Immunization Practices Improvement Program (IPI) wwwhealthstatemnusdivsidepcimmunizeipi
bull IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml) bull IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml) IPI Resource Folder Contents (wwwhealthstatemnusdivsidepcimmunizeipiipifolderpdf)
Minnesota Immunization Information Connection (MIIC) wwwhealthstatemnusmiic
bull MIIC regions and regional coordinators
Clinical Practice MDH Immunization Program wwwhealthstatemnusimmunize
Got Your Shots News wwwhealthstatemnusdivsidepcnewslettersgys
MDH Immunization Information for Health Care Providers wwwhealthstatemnusdivsidepcimmunizehcp
bull Got Your Shots A Providers Guide to Immunization in Minnesota bull Vaccine protocols bull Forms for tracking patient immunizations bull Immunization schedules for Health Care Providers Immunization Action Coalition (IAC) wwwimmunizeorg
bull Ask the Experts bull VISs (Vaccine Information Statements and translations) bull Administration screening questions bull Medical management of vaccine reactions bull Order form for Californiarsquos Immunization Technique DVD Best Practices with Infants Children and Adults
Page 52 IPI Advisor Manual| February 2017
IPI Advisor Resource List Chapter 5
CDC ldquoPink Bookrdquo wwwcdcgovvaccinespubspinkbookindexhtml
CDC Advisory Committee on Immunization Practices (ACIP) wwwcdcgovvaccinesacip
CDC Vaccines and Immunizations wwwcdcgovvaccines
VAERS reporting httpvaershhsgovindex
Storage and Handling Got Your Shots Providers Guide ndash Managing Vaccine wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml
MnVFC Guide to Temperature Monitoring Devices wwwhealthstatemnusvfc
MDH Clinicianrsquos Vaccine Mishap Checklist wwwhealthstatemnusdivsidepcimmunizeipivaxchklstpdf
MDH Vaccine Storage Guide wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml
CDC Vaccine Storage and Handling Toolkit wwwcdcgovvaccinesrecsstoragetoolkit
You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Vaccine manufacturer phone numbers wwwcdcgovvaccinespubspinkbookdownloadsappendicesFcontact-info-manufactpdf
IAC Checklist for Safe Vaccine Handling and Storage wwwimmunizeorgcatgdp3035pdf
IAC Donrsquot Be Guilty of These Errors in Vaccine Storage and Handling wwwimmunizeorgcatgdp3036pdf
Additional Resources Print materials from MDH ndash order forms wwwhealthstatemnusdivsidepcimmunizeordermathtml
Vaccine Education Center ndash Childrenrsquos Hospital of Philadelphia wwwchopeduservicevaccine-education-centerhomehtml
California Department of Public Health ndash Interactive training on vaccine administration and storage and handling handout on transporting vaccine and how to package wwwezizorg
IPI Advisor Manual | February 2017 Page 53
IPI Advisor Resource List Chapter 5
CDC vaccine price list wwwcdcgovvaccinesprogramsvfcawardeesvaccine-managementprice-listindexhtml
Vaccine Information Statements (VIS) wwwcdcgovvaccineshcpvisindexhtml
CEU Opportunities CDC Immunization Education and Training wwwcdcgovvaccinesedindexhtml
Immunization You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Page 54 IPI Advisor Manual| February 2017
- Introduction
-
- Welcome to the Immunization Practice Improvement (IPI) Program
- Contact Information
-
- Chapter 1
- Requirements to Participate in the MnVFC Program
- Vaccines for Children Program
- Chapter 2
- Reimbursement for MnVFC Visits
- Types of Visits
- Your MnVFC Clinical CoordinatorPlanner
- New IPI Advisor Training Requirements
- Your Role as an IPI Advisor
- Reasons MDH Would Do All or Part of a Visit
- Chapter 3
- Future follow-up
- Conducting the Visit
- Preparing for the Visit
- Information for the Visit
- Site Visit Checklist
- Scheduling the Visit
- Chapter 4
- After the Site Visit
- MnVFC Provider Follow-up Plan
- MnVFC Site Visit Storage and Handling Per Unit Answer Sheet
- Section 6 Inventory
- Section 5 Storage amp Handling Site-Wide
- Section 4 Storage amp Handling Per Unit
- Section 3 Documentation
- Section 2 Eligibility
- Section 1 Provider Details
- The Site Visit Reviewer Legend
- MnVFC Site Visit Questionnaire
- Required Paperwork for Site Visits
- Chapter 5
-
IPI Advisor Manual | February 2017 Page 23
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 232 Eligibility Vaccine Administration Fee
Question 23 Document the actual vaccine administration fee charged to non-Medicaid VFC-eligible patients (confirmwith billing department)
Answers Fee $ [X] Follow-up is required if the provider charges more than the fee cap establishedby the Centers for Medicare and Medicaid (CMS) for your stateterritory ($2122)
Review CDC Requirement
The VFC providerrsquos vaccine administration fee for non-Medicaid VFC-eligible children must not exceed the stateterritory vaccineadministration fee cap established by the Centers for Medicare and Medicaid (CMS) For current fee caps refer to Medicaid Program Payments for Services Furnished by Certain Primary Care Physicians and Charges for Vaccine Administration Under theVaccines for Children Program Final Rule (httpwwwgpogovfdsyspkgFR-2012-11-06pdf2012-26507pdf)
Goal of this question Ensure that sites are not charging more than the federal allowable vaccine administration fee of $2122
bull The Centers for Medicaid and Medicare (CMS) establishes a maximum fee that sites can charge to non-Medicaid-eligible VFC patients in each stateterritory for vaccine administration Health Plans usually negotiate this fee with the site but Medicaid will not pay more
bull If a parent cannot pay the vaccine administration fee the patient cannot be turned away or reported to collections VFC-eligible children must be vaccinated regardless of their ability to pay
bull If the person with whom you are conducting the site visit does not know the exact fee charged to non-Medicaid VFC-eligible patients ask to speak to someone who can verify the exact amount
bull If they are charging more than $2122 for the administration fee ndash please contact MDH staff for help with addressing this situation
Resources bull Immunization Billing Guidance for MnVFC (wwwhealthstatemnusdivsidepcimmunizemnvfc billingtipshtml) or Immunization Billing Guidance for MnVFC Replacement Method Sites (www healthstatemnusdivsidepcimmunizemnvfcreplacementbillingtipsrephtml)
bull Section 2 of the MnVFC Policies and Procedures Manual
Page 24 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 3 Documentation Question 31
3 Documentation Eligibility Screening amp Documentation
Question 31 To answer the questions below the provider must clearly demonstrate the patient intake processReview a minimum of 10 records that contain an immunization visit within the last 6 ndash 12 months
Note to Reviewer Criteria for Record Selection 1) Record selection must be completely random and the provider must not know prior to the visit which
records will be reviewed 2) Patient must have been 0-19 years of age at the last visit (Note Records of 19-year-old patients may
allow you to see if VFC vaccines are being used beyond the allowable age) 3) Must review a mix of public and private-pay patients (if applicable)
A Does the provider have a process that ensures that patients are screened forVFC eligibility at each visit and that screening results are documented at each visit
Yes No [X] (If no skip question F)
B Does the providerrsquos process ensure that staff administering vaccine know which vaccine stock to select from prior to drawing the vaccine
Yes No [X]
C Number of records reviewed If fewer than 10 records are reviewed select the reason why Provider does not have 10 patient records with immunizations in last 12 months
D Do all records contain date of the immunization visit and patientrsquos date of birth Yes No [X]
E Do all records contain the patientrsquos specific eligibility status associated with thedate of the immunization
Yes No [X]
F Do any of the providerrsquos records contain any evidence that the patient received vaccine for which they were not eligible
Yes [X] No
Review CDC Requirement
VFC providers must screen for and document VFC eligibility at each immunization visit Documentation must include the date of the visit and the childrsquos specific eligibility category VFC providers must use screening results to ensure that only VFC-eligible children receive VFC vaccine and that administration fees are billed for as appropriate Eligibility status must be readily available to staff administering vaccine prior to selecting which vaccine stock to use
Goal of this question Ensure the site is screening for eligibility and documenting the eligibility category in the medical record
Review a minimum of 10 records from within the last 6-12 months where the patient received an immunization You must review a mix of public and private pay patients (if applicable)
Random selection is important If the staff have pre-selected records for review do not use and identify additional randomly selected records to review
Helpful information bull Discuss upgrading the electronic health record to make documentation of VFC eligibility screening a required field Documenting eligibility screening in the immunization field promotes better MIIC data
bull Q 31 B Sites using the replacement method of vaccine management only have one stock so you will answer ldquoYesrdquo to this question
Resources bull Patient Eligibility Screening Record on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfcformshtml)
bull Section 1 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 25
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 32
3 Documentation Vaccine Dose Documentation
Question 32 Review a minimum of 10 patient immunization records from the last six months (or 12 months ifnecessary) to assess compliance with documentation requirements set forth by Statute 42 US Code 300aa-25 (See note to reviewer below)
Note to Reviewer Criteria for Record Selection 1) Record selection must be completely random the Provider must not know prior to the visit which records
will be reviewed 2) Patient must have been 0-19 years of age at the last visit (Note Records of 19-year-old patients may allow
you to see if VFC vaccines are being used beyond the allowable age)
Records are Compliant if they Contain ALL the Below Elements
bull Address of clinic where vaccine was administered bull Publication date of VIS bull Name of vaccine administered bull Name of vaccine manufacturer bull Date vaccine was administered bull Lot number bull Date VIS was given bull Name and title of person who administered the
vaccine
A Number of records reviewed
B Number of records that contain ALL required documentation elements
If fewer than 10 records are reviewed select the reason why Provider does not have 10 patient records with immunizations in last 12 months
[X] Follow-up isrequired if one ormore records do not meet requirements
Goal of this question Assess whether the site is documenting all required information in each patientrsquos medical record for every vaccine dose administered in accordance with the National Childhood Vaccine Injury Act
Resources bull Section 6 of the MnVFC Policies and Procedures Manual bull National Vaccine Injury Compensation Program (wwwhrsagovvaccinecompensation)
Question 33
3 Documentation Record Retention
Question 33 Is the provider able to demonstrate (preferred) or clearly describe how they maintain historical VFCeligibility documentation for three years
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers are required to maintain all records related to the VFC program for a minimum of three years (or longer if requiredby state law) and upon request make these records available for review VFC records include but are not limited to VFC screening and eligibility documentation billing records medical records that verify receipt of vaccine vaccine ordering records and vaccinepurchase and accountability records
Goal of this question Make sure the site understands they are required to keep all MnVFC screening documentation for at least three years either electronically or on paper This information should be available to you at the time of the visit and future visits
Resource bull Section 7 of the MnVFC Policies and Procedures Manual
Page 26 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 34
3 Documentation Borrowing Documentation
Question 34 Discuss borrowing practices with the provider to answer the questions below
Note to Reviewer bull To be considered ldquofully documentedrdquo documentation for each borrowed dose must include thefollowing information
Vaccine type borrowed Date the dose was administered Stock used (VFC or private) Reason appropriate vaccine stock was not used Patient name and date of birth Date dose was returned to appropriate stock
A Did the provider state that they had borrowed any vaccines (whetherdocumented or not) since the last VFC Compliance Site Visit
Yes No (If no skip to question 36)
B Are there any doses for which there is no documentation (ie provider hasindicated that doses were borrowed but cannot verify how many or why)
All doses are documented Some doses are not documented [X] No doses are documented [X] (if nodoses documented skip toquestion 36)
C Were all borrowed doses fully documented (See Note to Reviewer above) Yes No [X]
D Were all borrowed VFC doses either replaced or an order submitted to replacethe doses Yes No [X]
Review CDC Requirement
VFC providers are expected to maintain an adequate inventory of vaccine for VFC and non-VFC-eligible patients It is theresponsibility of the VFC provider to appropriately schedule and place vaccine orders VFC providers must also rotate stock to ensure timely use of short-dated vaccines Borrowing of vaccine between private and public inventories must be a rare unplanned occurrence and cannot serve as a replacement system for a VFC providerrsquos privately purchased vaccine inventory All instances ofborrowing must be properly documented reported and replaced
Goal of this question Assess vaccine accountability by verifying that children are receiving vaccine from the appropriate stock
Borrowing is when a fully insured child receives a dose of MnVFC vaccine or a MnVFC-eligible child receives a dose of private vaccine This should be a rare unplanned occurrence The site must document any borrowing of vaccine between stocks ideally on the VFC Borrowing Report Form If they are not currently using the form review it with them and encourage them to post it close to their vaccines It does not need to be sent to MDH but should be kept for 3 years and filed with their MnVFC documents to be reviewed whenever they have a regular or unscheduled (unannounced) site visit
Helpful information bull Understand and report on staffrsquos verbal (ie anecdotal) accounts of borrowing obtained during the visit Often sites do not know that what they do is considered borrowing or they think borrowing is acceptable and documentation isnrsquot needed so long as those vaccines are eventually replaced
bull Since sites using the replacement method only have one stock of vaccine they very rarely borrow bull This question asks for future follow-up in 6 months Make a note on your calendar and ask them to send you a copy of their borrowing reports for the previous 6 months with documentation of doses borrowed and replaced We will remind you if we donrsquot hear from you at the 6 month time frame Complete the Follow-up Form and attach the borrowing form
Resources bull Vaccine Borrowing Report on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfc formshtml)
bull Section 10 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 27
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 353 Documentation Borrowing Reasons
Question 35 Based on your discussion with the provider and a review of borrowing reports document the dosesborrowed for each reason and answer the questions below
Note to Reviewer bull Short-dated vaccines are doses that are likely to expire before they can be used bull Exchanging short-dated vaccines should only occur in practices that have a small number of private
patients
A Reasons for Borrowing a VFC Dose (Enter the number of _____ Private vaccine shipment delay (order placed on time but delay in shippingreceipt)
vaccine doses borrowed for each
reason in the spaces
_____ Private vaccine not useable on arrival (vials broken temperature monitor out of range) _____ Ran out of private vaccine between orders (provider orders not placed on time) [X]
provided) _____ Short-dated private dose was exchanged with VFC stock _____ Accidental use of VFC dose for a private patient (human error) _____ Replacement of private dose with VFC when insurance plan did not cover vaccine _____ OtherDocumented dose did not include reason for borrowing [X]
(Explanation Required) Reasons for Borrowing a Private Dose _____ VFC vaccine shipment delay (order placed on time but delay in shippingreceipt) _____ VFC vaccine not useable on arrival (vials broken temperature monitor out of range) _____ Ran out of VFC stock between orders (provider orders not placed on time) [X] _____ Short-dated VFC vaccine dose was exchanged with private dose _____ Accidental use of a private dose for a VFC-eligible patient (human error) _____ OtherDocumented dose did not include reason for borrowing [X]
(Explanation Required)
B Enter date range for instances of borrowing reviewed in the borrowing report Note If ldquoDate of earliest instancerdquo is not available use the date of the last VFC Compliance Visit If ldquoDate of last instancerdquo is not available use the date of thecurrent VFC Compliance Visit
Date of earliest instance
Date of last instance
C Does borrowing appear to be a routine practice Note To determine whether borrowing is a routine practice assess frequency of and repeating reasons for borrowing Examples Frequent accidental use of incorrect stock exchanging short-dated vaccines or issues with ordering and shipment
Yes [X] No
Goal of this question Determine the reasons why the site is borrowing vaccine
If sites are using the Vaccine Borrowing Report review the reasons for borrowing to help document borrowed VFC andor private doses If they have not been documenting borrowing on this report (or any other form) estimate their borrowing practices If you do not know the date range for their borrowing use the last site visit date to the current visit date The use of ldquootherrdquo as the reported reason for borrowing should be rare if ever and would require explanation and follow up
Helpful information bull Look to see if they routinely maintain insufficient amounts or types of vaccine to support their public and private patients that leads to borrowing
bull Pay attention to borrowing cases documented as ldquoaccidentalrdquo Repetitive accidental borrowing may indicate an issue with ordering processes or insufficient staff training
bull Borrowing is not a place to document wasted or lost doses bull The time period of the borrowing may give you clues about the root cause Were the borrowed doses concentrated in a short period or spread out across several months or a year Are all vaccine types being borrowed or just one
bull If borrowing seems to be an issue discuss vaccine management ordering procedures
Resources bull Vaccine Borrowing Report on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfc formshtml)
bull Section 10 in the MnVFC Policies and Procedures Manual
Page 28 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 36
3 Documentation Vaccine Management Plan
Question 36 Physically review the providerrsquos Vaccine Management Plan to answer the question below
A Does the provider have a Vaccine Management Plan Yes No [X] (If no skip to question 37)
B Does the plan list the current Immunization Manager Vaccine Coordinator andback-up
Yes No [X]
C Does the plan address proper vaccine storage and handling practices Yes No [X]
D Does the plan specify vaccine receiving procedures Yes No [X]
E Does the plan contain procedures for what to do with vaccine in the event of an emergency
Yes No [X]
F Does the plan contain procedures for vaccine ordering Yes No [X]
G Does the plan address inventory control (example stock rotation) Yes No [X]
H Does the plan address how to handle vaccine wastage Yes No [X]
I Does the plan address staff training and documentation on vaccine managementstorage amp handling
Yes No [X]
J Does the plan contain a review date that falls within the last 12 months Yes No [X]
K Has the plan been signed by the individual responsible for its content Yes No [X]
Review CDC Requirement
VFC providers must develop maintain and implement a Vaccine Management Plan for routine and emergency vaccinemanagement The plan must contain the current Vaccine Coordinator and back-up proper storage and handling practicesshipping and receiving procedures emergency procedures procedures for vaccine ordering inventory control (eg stock rotation)how to handle vaccine wastage and staff trainingdocumentation on vaccine management storage and handling The plan must bereviewedupdated annually or more frequently if changes occur A ldquoreview daterdquo and signature are required on all plans in order tovalidate that they are current
Goal of this question Evaluate the sitersquos plan for vaccine management It is especially important that they have a plan for emergency management of their vaccine in the case of equipment failure or power outage Encourage all sites to read and sign the MnVFC Policies and Procedures Manual and complete the emergency plan or be able to show you a plan of their own
If the provider is not able to physically show you the plan at the time of the visit or if the recorded review date is not within the last 12 months you must mark that this requirement is unmet The Vaccine Management Plan is important in times of emergency and it should be easy to access by any staff member at any time Encourage them to post the plan and put a copy with the packing supplies
Helpful information bull Encourage the site to fill in the ldquoImmunization Managerrdquo and ldquoVaccine Coordinatorrdquo fields in the
MnVFC Policies and Procedures Manual for their own referencebull The emergency plan in the manual can be reviewed from last year and included in this yearrsquos manual (with an updated signature and date) if there have not been any changes
bull If information in the plan is outdated site staff will not be well equipped to safely manage vaccines in the event of a power-outage or other emergency situation
bull If their institutional policy is only reviewed and updated every 3-4 years (as many are) the staff may need to sign the MnVFC Polices and Procedure Manual to meet this requirement
Resource Routine Vaccine Management Plan and Emergency Vaccine Management Plan in the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 29
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 37
3 Documentation VIS amp VAERS
Question 37 Review the providerrsquos Vaccine Information Statements (VISs) and discuss providerrsquos VAERS process toanswer the questions below
A Does the provider have readily available up-to-date VISs for all ACIP-recommendedvaccines relevant to the populations it serves
Yes No [X]
B Does the provider make a VIS available for patientsparents before eachvaccination
Yes No [X]
C Does the provider know how and when to report clinically significant adverseevents using VAERS
Yes No [X]
Review CDC Requirement
VFC providers are required to distribute the current Vaccine Information Statements (VIS) each time a vaccine is administered and maintain records in accordance with the National Childhood Vaccine Injury Act (NCVIA) which includes reporting clinicallysignificant adverse events to the Vaccine Adverse Event Reporting System (VAERS) For a list of current VISs visit CDCrsquos Vaccine Information Statements (httpwwwcdcgovvaccineshcpvis) website
Gal of this question Ensure the site has the most current VISs and is giving them to each patientparent before administering the vaccine in compliance with the federal law Parents must be educated about the vaccine their child will receive and be aware of possible contraindications and side-effects in order to make well-informed decisions about their childrsquos health
Helpful information bull Ask to see the sitersquos VISs to determine if they have an active protocol for giving VISs to parents Review to make sure they are current Ask if they know where and how to report vaccine adverse events
Resources bull Section 3 in the MnVFC Policies and Procedures Manual bull CDC Vaccine Information Statements (wwwcdcgovvaccineshcpvisindexhtml) Site may sign up for email updates for the current list of VIS publication dates for the most up-to-date version
bull IAC Itrsquos Federal Law You must give your patients current Vaccine Information Statements (wwwimmunizeorgcatgdp2027pdf)
bull VAERS (httpsvaershhsgovindex)
Question 38
3 Documentation Anaphylaxis protocol
Question 38 Does the site have an anaphylaxis protocol which is clearly posted near the emergency kit
Answers (Choose one)
Yes No [X]
Review CDC Requirement
An anaphylaxis protocol must be clearly posted in the area where vaccines are administered
Goal of this question Make sure site is prepared for a severe allergic or anaphylactic reaction to a vaccine
Resources bull Section 11 in the MnVFC Policies and Procedures Manual bull IAC protocols Child and Teens (wwwimmunizeorgcatgdp3082apdf) and Adults (wwwimmunize orgcatgdp3082pdf)
Page 30 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
i
i i i - li i i i i i l
Section 4 Storage amp Handling Per Unit The goal of this section is to assess vaccine storage
2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet practices in each unit at the site MnVFC PIN ___________________
The 2017 MnVFC Storage amp Handling Per Unit Answer Sheet is a worksheet to document the answers to the questions in this section for each unit (combination or stand-alone) Fill in the answers to the questions in Section 4 on the answer sheet not in the questionnaire
The answer sheet has an abbreviated form of each question If you need further information on that question refer back to the full questionnaire Also if you find an area where the site is not meeting the requirements you will need to go back to that question on the 2017 MnVFC Site Visit Questionnaire to complete ldquoActions if Non- compliantrdquo section including the root cause analysis and follow-up sections If there is a problem in more than one unit make a note on the questionnaire which unit you are referring to in the Notes section
Important You must fully assess any unit that may be used to store VFC vaccines even if there are no VFC vaccines there on the day of the visit If there are no vaccines and the site is not documenting twice a day temperatures discuss the need to ensure the unit is maintaining stable temperatures by monitoring for one week before placing vaccines in the unit
Quest on number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
for the freezer and e co umn
Temperature Monitoring Dev refr gerator f the un
ce Quest ons Quest ons 4 3 4 7 must be answered separate y t s a combo Be sure to document responses n the appropr at
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
44D Data downloaded and reviewed routinely (eg weekly)
Yes No [O]
Yes No [O]
45A Certificate of Calibration Testing Yes No [X]
Yes No [X]
45B Date of calibration
45C Date certificate expires [X] Follow-up is required if expired [X] Follow-up is required if expired
45D Certificate contains all necessary items
Yes No [X]
Yes No [X]
46 Probe properly placed Yes No [X]
Yes No [X]
47A Two temperature readings per day
Yes No [X]
Yes No [X]
47B Time date and name (or initials) for each reading
Yes No [X]
Yes No [X]
47C Current temperature and minmax temperatures (if
Current ________deg Minimum ________deg Maximum _deg
Current ________deg Minimum ________deg Maximum _deg
Sections 5 and 6 contain questions about storage and handling site wide and inventory It is helpful to keep those questions in mind as you assess the individual storage units Think about dorm-style units expired vaccine vaccine supply room for vaccine stocking all the recommended vaccines and separation of stock if appropriate
NOTE The sections that follow require reviewers to validate responses by looking at vaccine storage units temperaturemonitoring equipment and the vaccine inventory inside a unit bull For section 4 use a separate Storage amp Handling Per Unit Answer Sheet for each unit to document the findings (combination
units using both sections can be documented on the same answer sheet) bull When an unmet requirement is identified return to this questionnaire to complete the ldquoActions if Non-compliantrdquo section for
that question bull After you complete one answer sheet for each unit return to the questionnaire to complete sections 5 and 6 using information
you gathered while assessing the units The questions in sections 5 and 6 (Storage amp Handling Site-Wide and Inventory) are notunit-specific but do require that the response be based on a thorough assessment of all the providersrsquo units
4 Storage amp Handling Per Unit
Description On the Storage amp Handling Per Unit Answer Sheet place a name that will allow you or someone else from your program to easily identify this unit in the event of follow-up We recommend using Brand + Location(example Samsung - Room 123) Save each Storage amp Handling Per Unit Answer Sheet with the Brand + Location in the file name
(example SamsungRoom123doc)
IPI Advisor Manual | February 2017 Page 31
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 41
4 Storage amp Handling Per Unit Storage Unit Build amp Use
Question 41 Below select the build and use of the vaccine storage unit you are assessing
Note to Reviewer Dorm-style units Do not add dorm-style units here Dorm-style units will be addressed in section 5 Units storing only private stock You must review these storage units even if they contain only private stockat the time of the visit because that vaccine could be administered to VFC patients
A What type of unit is this A Stand-alone B Combination
B Select use if stand-alone A Freezer B Refrigerator
Select use if combination A Use both sections to store vaccine B Use freezer section only to store vaccine C Use refrigerator section only to store vaccine
Goal of this question Identify the unit you are evaluating The description asks you to create a unique name for this unit so that you will be able to identify the same unit in future site visits Put this description on the top of the answer sheet (ie make and location)
Helpful information bull A stand-alone unit is either a refrigerator or a freezer It does not have both sections in the unit bull If there is a combination unit note if the site uses both the refrigerator and freezer or only one section of the unit to store vaccines CDC does not recommend the use of either section or the freezer section only of combination household units
bull If your site utilizes the separate stock method of vaccine management you must review storage units even if they contain only private stock at the time of the visit because there is a chance that those vaccines could be administered (borrowed) to VFC-eligible patients
Page 32 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 424 Storage amp Handling Per Unit CDC Recommended Storage Units
Question 42 Below document the grade of the vaccine storage unit you are assessing
Note to Reviewer Pharmaceutical Also called ldquopurpose-builtrdquo these units are designed by the manufacturer specifically tostore vaccines or other biological materials Commercial Although usually intended to store food and beverages commercial units are often larger and more powerful than the household units found in most homes Though these units are intended to meet thehigher demands of larger facilities these units are not specifically built for the storage of biologicalmaterials Household (non-commercialdomestic) These units are usually smaller than commercial units and areintended for use in small offices and in homes ndash typically for food storage However just like commercialunits they are not designed specifically for the storage of biological materials Such units are usually available in common home supply stores
Answers (Choose one)
Select grade A Pharmaceutical B CommercialHousehold
[O] CDC does not recommend the use of both sections or the freezer section only of combination commercialhousehold units
Review CDC Recommendation
CDC recommends the following vaccine storage unit types (in order of preference) pharmaceutical grade stand-alone orcombination units (preferred) householdcommercial stand-alone units householdcommercial combination units using therefrigerator section only
Goal of this question Assess the grade and type of each storage unit bull Pharmaceutical grade units may be stand-alone or combination units that are often metal may have glass in the door for viewing inside often have an external digital temperature display and are manufactured by medical companies
bull Commercial or household units often look like your kitchen appliance have vegetablemeat drawers in the unit and are manufactured by household appliance companies
bull Occasionally you might find a medical grade unit which is usually a commercialhousehold unit with a lock and 3-prong plug These are still considered household units because of their ability to maintain proper temperatures and air flow Studies show that household stand-alone units are better able to maintain consistent temperatures than their combination counterparts Combination household units used to store vaccine in both sections of the unit is no longer recommended and may be prohibited in the future Combination household storage units that are having difficulty maintaining a cold enough freezer temperature and a warm enough refrigerator temperature should be replaced or a separate stand-alone freezer should be purchased
For frozen vaccines the most cost effective solution is for the site to purchase a small stand-alone freezer The site may need time to budget for a stand-alone storage unit
Resources bull Replacing Combination Household Units Tip Sheet on IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml)
IPI Advisor Manual | February 2017 Page 33
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 434 Storage amp Handling Per Unit Temperature Monitoring Device in the Unit
Question 43 Determine whether there is a temperature monitoring device in this section of the storage unit andanswer the questions
A Is there a temperature monitoring device in this section of thestorage unit
Yes No [X] (If no skip to question 47)
B Who is responsible for supplying the temperature monitoring device in this section of the storage unit Provider
Review CDC Requirement
Certificates of calibration testing provide confidence that the temperature monitoring device is measuring temperaturesaccurately All units storing VFC vaccines must have a calibrated temperature monitoring device with a current and valid certificateof calibration testing All certificates must contain modeldevice name or number serial number date of calibration testing (report or issue date) and Instrument Passed testingInstrument in Tolerance (Recommended uncertainty = +-05ordm C (+-1ordm F))
Goal of this question Assess whether there is a temperature monitoring device in the unit If the unit is not being monitored at all call MDH at 651-201-5522 for guidance
Helpful information bull This question does not ask whether the temperature monitoring device is working or the characteristics of the device These issues will be addressed later in the questionnaire
bull For part B the provider is always responsible for supplying the temperature monitoring device Even if their thermometer or data logger was originally from MDH it is their responsibility to ensure it is functional and calibrated
Resources bull Section 8 in the MnVFC Policies and Procedures Manual
Page 34 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 444 Storage amp Handling Per Unit CDC Recommended Temperature Monitoring Device
Question 44 Assess the temperature monitoring device in this section of the storage unit to answer the questionsbelow
A Is the temperature monitoring device a continuous monitoring and recordingdevice (eg data logger)
Yes No [O] (Skip D)
B Does the temperature monitoring device have a probe in buffered material Yes No [O]
C Does the temperature monitoring device have a digital display that can beeasily read from the outside of this unit
Yes No [O]
D Is data downloaded and reviewed routinely Yes No [O]
Review CDC Recommendation
As of Jan 1 2018 all VFC providers must use continuous temperature monitoring devices (eg data loggers) to monitor vaccinesthat will be administered to VFC-eligible children Routine review and accessibility of temperature data is critical for determining whether vaccine has been properly stored and for assessing usability of vaccine that was involved in a temperature excursion Tomeet VFC Program requirements the device must also be equipped with bull A temperature probe bull An active temperature display that can be easily read from the outside of the unit bull The capacity for continuous monitoring and recording capabilities where the data can be routinely downloaded
The following are additional recommended features for these devices bull Alarm for out-of-range temperatures bull Current minimum and maximum temperatures display bull Low battery indicator bull Accuracy of +- 1degF (05degC) bull Memory storage of at least 4000 readings bull User programmable logging interval (or reading rate) recommended at a maximum time interval of every 30 minutes bull Use of a probe that best reflects the temperature of the vaccine (such as a buffered probe)
Goal of this question Assess the temperature monitoring device in the storage unit Note that these are all recommendations not requirements at this time
This is a great teaching opportunity for sites who do not currently have a continuous temperature monitoring device Beginning Jan 1 2018 all units that store MnVFC vaccine will be required to have a continuous temperature monitoring device (ie a data logger or a continuous temperature monitoring system) Unlike a minmax thermometer a continuous temperature monitoring device provides detailed information on all temperatures recorded at pre-set intervals For excursions it can provide information on when a temperature went out-of-range for how long and what the temperatures were This is essential information that vaccine manufacturers need to know to assess the viability of the vaccine following an excursion
Helpful information bull Sites are required to monitor and record temperatures twice daily however temperature excursions can easily occur in the 12 hours or longer between readings Continuous temperature monitoring can help manufacturers determine vaccine viability
bull Continue to encourage sites to document and evaluate minimum and maximum temperatures the storage unit reached since the last reading and respond appropriately to out-of-range temperatures
IPI Advisor Manual | February 2017 Page 35
The 2017 MnVFC Site Visit Paperwork Chapter 4
bull It is recommended that sites download and review data weekly Discuss with sites that reviewing temperature monitoring device data also includes responding appropriately if they identify out-of-range temps
bull There is sometimes confusion about the difference between a data logger and a continuous temperature monitoring system Here are some differences
Data Loggers Continuous Monitoring Systems Have an external display similar to thermometers May or may not have an external display Have a detachable probe Probe is usually attached to transmitter Need to be plugged into the computer or cradle to download information on a regular schedule
Wirelessly sends data to computer system
Create a file of data that needs to be saved on the computer
Data is stored within the system not a separate file
Doesnrsquot allow documentation of twice a day temperature checks in the file
May allow documentation of twice a day temperature checks within the system
More about the 2018 requirement for a continuous temperature monitoring device
Required Features bull The continuous temperature monitoring device must have Continuous monitoring and recording capabilities to track and record temperatures over time The capacity to routinely download temperature data to a computer (recommended at least weekly) or wirelessly transmit data Detachable probe in a bottle filled with a thermal buffer (eg bio-safe glycol) if the data logger needs to be detached in order to download data Active temperature display
Recommended Features bull MnVFC recommends continuous temperature monitoring devices with Alarm for out-of-range temperatures Accuracy within +-1degF (+- 05degC) Low battery indicator Display of current minimum and maximum temperatures Memory storage of at least 4000 readings User programmable logging intervals (eg the user can set how often the device records the temperature)
Note that these are all currently recommendations not requirements yet
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Page 36 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 45
Goal of this question Ensure the temperature monitoring device is properly calibrated The certificate of calibration testing means that the device has been tested and it is accurately measuring temperatures within established testing limits The certificate of calibration ensures that the device meets all the required components
Helpful information bull The provider is always responsible for having a current certificate of calibration (or copy) on-site
bull To be considered ldquovalidrdquo a certificate of calibration must contain these required elements Modeldevice name or number Serial number
4 Storage amp Handling Per Unit Certificate of Calibration Testing
Review CDC Requirement
Certificates of calibration testing provide confidence that the temperature monitoring device is measuring temperaturesaccurately All units storing VFC vaccines must have a calibrated temperature monitoring device with a current and valid certificateof calibration testing All certificates must contain modeldevice name or number serial number date of calibration testing (report or issue date) and Instrument Passed testingInstrument in Tolerance (Recommended uncertainty = +-05ordm C (+-1ordm F))
Question 45
Note to Reviewer
A
B
C
D
E
Review the certificate of calibration testing for the temperature monitoring device in this section of the storage unit and answer the questions below
bull How to determine certificate of calibration testing expiration date 1) Identify the certificate issuecalibration date 2) Apply the Immunization Program-required frequency for calibration testing Example If the
issuecalibration date is 12312013 and Immunization Program policy requires testing every twoyears the expiration date is 12312015
bull Certificates must include all of the below bull ModelDevice Name or Number bull Serial Number bull Date of Calibration Testing (Report or Issue Date) bull Instrument Passed testing (Instrument in Tolerance)
Is there a certificate of calibration testing for the temperature monitoring Yes device in this section of the storage unit No [X]
What is the date of calibration for the temperature monitoring device in this section of the storage unit
What is the certificatersquos date of expiration based on ImmunizationProgram policy (See note to reviewer to determine expiration date) [X] Follow-up is required if
certificate is expired
Does the certificate contain all the necessary items listed in the Note to Yes Reviewer No [X]
Who is responsible for supplying the current and valid certificate of Provider calibration for this temperature monitoring device
Date of calibration testing (report or issue date) Note If there is no expiration date the certificate expires 2 years from the date of calibration Whether the instrument passed or failed testing (or instrument in tolerancenot in tolerance)
bull Recommended element Documented uncertainty of +- 1degF [05degC]
If these elements are present the certificate is considered valid If the certificate contains information about the recommended element or the entity that issued the certificate that is helpful but not required
To determine if a certificate of calibration testing was issued by an appropriate entity check to see if the certificate indicates one or more of these items (this is the wording used to help sites evaluate if their calibration is accurate but is not required on the certificate itself to be considered valid)
bull Conforms to ISO 17025 bull Performed by an ILACMRA Signatory body accredited laboratory You can review this list of the ILAC MRA and Signatories (httpilacorgilac-mra-and-signatories)
bull Traceable to the standards maintained by NIST bull Meets specifications and testing requirements for the American Society for Testing and Materials (ASTM) Standard E2877 tolerance Class F (le 05 degC) or better
bull Includes reference to another acceptable accuracy validation method such as comparison to other traceable reference standards or tests at thermometric fixed points
Note CDC recommends that certifications be issued for the entire monitoring unit (detachable probe data logger etc) and not individual certificates for each component
IPI Advisor Manual | February 2017 Page 37
The 2017 MnVFC Site Visit Paperwork Chapter 4
For 45 E the provider is always responsible for supplying the current and valid certificate of calibration for a temperature monitoring device
bull Tip If the temperature monitoring device has a sticker on the back with the calibration date the site can usually call the company who calibrated the device and get a copy of the certificate if they donrsquot have one
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 46 4 Storage amp Handling Per Unit Probe Placement
Question 46 Is the probe properly placed in this section of the storage unit
Note to Reviewer ldquoProperlyrdquo means that the probe in a commercial or household unit is placed in a central area of the unitdirectly with the vaccines Probes should not be placed in the doors near or against the walls close to vents or on the floor of the unit The only allowable exemption related to this requirement is for providerswho have pharmaceutical storage units (built for vaccine storage) that have either (1) a built-intemperature monitoring device OR (2) a dedicated port for the probe that dictates the placement of theprobe
Answers (Choose one)
Yes No [X]
Review CDC Requirement
The probe must be placed in a central area of the section of the storage unit directly with the vaccines in order to properly measurevaccine temperature The probe should not be placed in the door near or against the walls close to vents or on the floor of theunit For pharmaceutical units with a built-in temperature monitoring device or a dedicated port for a probe that is not in thecenter of the section of the storage unit consult your Immunization Program for guidance on placement
Goal of this question Make sure the temperature monitoring device is in the best location to accurately measure the temperature of the vaccines stored in the unit
Helpful information bull The probe of the temperature monitoring device should be placed directly with the vaccines in the middle of the unit The ONLY allowable exception is for pharmaceutical storage units that have either a built-in thermometer or a dedicated port for the probe that indicates placement of the probe
bull Temperatures can vary within the unit especially household units bull Call MDH at 651-201-5522 if you have questions
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Guide (wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml)
Page 38 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 474 Storage amp Handling Per Unit Temperature Documentation
Question 47 Review the temperature documentation over the past three months for this section of the storage unit todetermine whether the provider has a process in place for properly documenting temperatures twice aday Answer the questions below
A Are there two temperature readings recorded for this section of the storage unit per day
Yes No [X]
B Is there a time date and name (or initials) recorded for each reading Yes No [X]
C What is the current temperature and minmax temperatures (if available) inthis section of the storage unit Use the reviewerrsquos thermometer if the providerrsquos temperature monitoringdevice does not have a current valid certificate of calibration testing or the probe is not properly placed in this section of the storage unit
Current Temperature Minimum Temperature Maximum Temperature Fahrenheit Celsius
D Based on your review of the providerrsquos recent temperature documentationincluding the current temperature is this section of the storage unitmaintaining appropriate temperatures
Yes No [X] Not enough information [X]
Review CDC Requirement
Vaccines must be stored under appropriate temperatures as described in the package inserts at all times Acceptable temperature ranges vary by vaccine type and the range is 36deg F and 46deg F (2deg C and 8deg C) and for frozen vaccines the range is -58deg F and +5deg F (shy50deg C and -15deg C) Exposure to temperatures outside of those included in the package inserts could affect vaccine viability andultimately could leave children unprotected against vaccine-preventable diseases In order to maintain awareness of storage unittemperatures and ensure that vaccines are being stored at appropriate temperatures at all times VFC providers are required to monitor and document temperatures for all vaccine storage units at least twice a day Temperature documentation must contain (1) at least two temperature readings per day (2) the time and date of each reading and (3) the name (or initials) of the personwho assessed and recorded the readings CDC also recommends that VFC providers record the minimum and maximumtemperatures of each unit once each workday (preferably in the morning)
Goal of this question Ensure the temperature is being monitored twice daily is within the required range and documented correctly Use your thermometer to check the temperature if the sitersquos temperature monitoring devicersquos probe is not properly placed or there is not a current certificate of calibration Place your thermometer in the unit at the beginning of the visit to allow sufficient time to reach an accurate temperature The purpose of using your thermometer is to ensure the vaccine is being stored at the proper temperature not to ldquovalidaterdquo their reading
Question 47 D is an assessment question based on information you have learned during your visit You might answer ldquonot enough informationrdquo if the unit is new and they donrsquot have at least three months of data or if the unit is only used as overflow and they are inconsistent with temperature monitoring Mark ldquoNordquo if you have reason to believe the storage unit is not maintaining temperatures properly
Helpful information bull All sites must document temperatures twice a day every day the site is open even if they have a data logger or continuous monitoring system
bull Sites can document the information electronically with some continuous monitoring systems as long as it can show what the current temp is the date time and initials of the person checking ndash this needs to be someone at the site ndash not checking remotely or centrally for a large site or system The site must be able to produce these records during their site visit Reviewing these files can be a challenge due to large volumes and lots of paper
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Temperature Logs on Managing Vaccine (wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml)
IPI Advisor Manual | February 2017 Page 39
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 484 Storage amp Handling Per Unit Temperature Excursions
Question 48 In the event that a temperature excursion(s) occurred in this unit within the last three months requestand review documentation of actions taken to determine whether the provider has a process for properlyaddressing excursions Answer the questions below
A Were vaccines in this unit exposed to out-of-range temperatures in the lastthree months (including today)
Yes No (If no skip to question 49)
B Did the provider quarantine and label vaccines as ldquoDo not userdquo Yes No [X]
C Did the provider place vaccine in a unit where it can be stored under properconditions if applicable
Yes No [X]
D Did the provider contact the Immunization Program to report theexcursion
Yes No [X]
E Was the manufacturer contacted for documentation supporting theusability of the vaccine
Yes No [X]
Review CDC Requirement
The provider must document all excursions and actions taken including the following (1) Quarantine and label vaccines as ldquoDO NOTUSErdquo (2) Place vaccines in a unit where they can be stored under proper conditions (3) Contact the Immunization Program to report an excursion and (4) Contact the vaccine manufacturer to obtain documentation supporting the usability of the vaccine
Goal of this question Address any out-of-range temperatures (temperature excursions) identified in reviewing the last three months of temperature logs or during the site visit If there were any out-of-range temperatures did the site respond appropriately to the situation This is a great opportunity to discuss what to do in the event of an excursion The Clinicians Storage and Handling Mishap Checklist is in the IPI Site Visit information folder and is a good review of the process
Helpful information bull Sites need to know that an excursion does not automatically mean that exposed vaccines are non-viable or unusable Exposed vaccines must be quarantined (marked ldquoDo Not Userdquo) and stored under proper conditions until they have received information from vaccine manufacturers regarding the viability of the vaccine
bull Sites must inform MDH when an excursion occurs
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Clinicians Storage and Handling Mishap Checklist (wwwhealthstatemnusdivsidepcimmunize ipivaxchklstpdf)
Page 40 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 49
Goal of this question Ensure proper placement of vaccines in the storage unit
Note These are all recommendations (best practices) not requirements
Helpful information bull Store vaccine in the middle of the compartment two to three inches away from the coils walls floor and cold air vent The temperature near the floor and walls of the unit differs from that in the middle of the compartment and the cold air vent can freeze refrigerated vaccines
4 Storage amp Handling Per Unit Vaccine Placement
Question 49 Look inside the unit to answer the questions below
A Are vaccines placed in the middle of the unit with space between vaccinesand the sideback of the unit to allow cold air to circulate
Yes No [O]
B Are vaccines stored in their original packages Yes No [O]
C Are there water bottles (for refrigerators) or frozen water bottles (forfreezers) in the unit
Yes No [O]
D Are vaccines store in the doors vegetable bins under or near cooling ventsor on the floor of the unit
Yes [O] No
E Is food being stored in the unit Yes [O] No
Review CDC Recommendation
Vaccines should be stored in their original manufacturer (or CDC centralized distributor) packaging They should be placed in the middle of the unit with space between the vaccines and the sideback of the unit to allow cold air to circulate Vaccines SHOULD NOT be stored in the doors vegetable bins or floor of the unit or under or near cooling vents and there should not be any food inthe unit Water bottles (for refrigerators) or frozen water bottles (for freezers) should be placed throughout each storage unit inorder to (1) stabilize or extend temperatures during a power outage and (2) to serve as physical blocks preventing the placementof vaccines in areas of the unit that are at higher risk for temperature excursions (such as in doors vegetable bins floor ornearunder cooling vents)
bull Vaccines should be kept in their original packaging to Protect them from light Help prevent medication errors by making labels easier to read Provide a moisture barrier that serves as insulation in case of an out-of-range temperature power outage door left open or mechanical failure Simplify managing vaccine inventory
bull Store water bottles in the doors on the floor and near the cold air vent in the refrigerator and frozen water bottles in the freezer to help maintain a stable temperature if there is a power failure and when the door is opened frequently Too many water bottles in the door can prevent the door from closing tightly Mark water bottles ldquoDo Not Drinkrdquo
bull Do not store vaccine in the door or drawers of the refrigerator or freezer Vegetable bins and crisper drawers should be removed from refrigerators or used to store other medical supplies or water bottles
bull If vaccine is stored in a household combination refrigeratorfreezer The top shelf should not be used for storing vaccine because the cold air vent blowing from the freezer will freeze vaccine located there If you must use the top shelf of this type of unit place water bottles underneath the cold air vent to prevent vaccine from being stored there It is recommended that only the refrigerator be used for vaccine storage and a separate stand-alone freezer be used to store frozen vaccine
bull Must not store food or beverages in the refrigerator or freezer because frequent opening of doors can lead to temperature variations that may affect vaccine viability There is also a risk of contaminating vaccines
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Guide (wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml) bull Vaccine Storage Tip Sheet on IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml)
IPI Advisor Manual | February 2017 Page 41
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 4104 Storage amp Handling Per Unit Disconnection from Power Source
Question 410 Ask the provider to demonstrate what measures are taken to ensure that vaccine storage units are notaccidentally physically disconnected from the power supply Which of the following describes the measure(s) taken on this unit
Note to Reviewer bull Large hospitals and healthcare systems may not have the ability to demonstrate labels on plugs or circuitbreakers In such cases verify that the practice has a comprehensive policy and standard operatingprocedures in place to prevent the vaccine storage unit from being physically disconnected from thepower supply
bull While back-up generators may ensure power to the overall facility this question ONLY addresses thevaccine storage unit being accidentally disconnected from the power source either through the plug orthe circuit breaker
Answers A ldquoDo not disconnectrdquo labels on the plug (Choose all that B ldquoWarningrdquo label on the circuit breaker box
apply) C Hard-wired (ie built-in) and has a ldquoDo not disconnectrdquo label on thecircuit breaker box D Hospital or large health care system with a comprehensive written policyand standard operating procedures detailing measures taken to preventvaccine storage units from being accidentally disconnected from the powersupply E No acceptable measures for preventing accidental disconnection frompower supply [X]
[X] The response is non-compliant if only A only B or E is selected
Review CDC Requirement
VFC providers must take steps to protect the power source for all vaccine storage equipment by means of having clear warninglabels on both the plug and the circuit breaker associated with all vaccine storage units Large hospitals and healthcare systems canmeet this requirement by demonstrating that they have comprehensive policies and standard operating procedures to preventvaccine storage units from being physically disconnected from the power supply
Goal of this question Decrease the chance that a vaccine storage unit will be accidently unplugged or power will be turned off while vaccine is in the unit This question addresses only what measures the site has taken to ensure the storage unit is not physically disconnected from its power source
If the site uses labels on the plugs and circuit breakers perform a visual inspection to assess whether the way the stickers are positioned make it clear and obvious to anyone that these units are not to be disconnected
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Do Not Unplug and Warning stickers are included in the folder or available to order on the For
Professionals Order Form (wwwhealthstatemnusdivsidepcimmunizeordermathtml)
Note Once you have completed the 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet for each unit return to the questionnaire to complete sections 5 and 6
Page 42 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
- -
Section 5 Storage amp Handling Site-Wide Question 51
5 Storage amp Handling Site Wide Discussion of Cost amp Quantity of Vaccine
Question 51 Have a discussion with the provider about the cost and quantity of VFC vaccines they are responsible for annually Address the points listed in the note to reviewer below
Note to Reviewer bull Vaccine Shipped (Required) Share the cost of VFC vaccines shipped to the provider in the last calendaryear to make sure the provider understands the contribution made by the VFC Program to their practiceFor new providers who do not have ldquocalendar yearrdquo data share either the actual cost of their currentinventory or use the cost of 10 VFC doses of each of the ACIP-recommended vaccines (approximately $7000) to help estimate their annual cost
bull Storage amp Handling (Required) Make sure the provider understands the cost of vaccines for which they are responsible when they make decisions about purchasing recommended vaccine storage and temperature monitoring equipment
Answer I have discussed with the provider the cost and quantity of vaccines ordered in the previous calendar year
Goal of this question Inform sites of the quantity and value of vaccines that they receive as part of the MnVFC program Providers often donrsquot realize the value of the vaccine in their unit This information is included on your clinic list and on the one page site-specific information
Helpful information bull This discussion must occur and the box on the questionnaire must be checked bull If there isnrsquot actual vaccine value information available tell the site that one vaccine order that includes a box of each of the ACIP recommended vaccines costs approximately $7000
bull MDH may not have specific information for individual sites if they receive vaccine from a central warehouse or pharmacy For those sites MDH will give you numbers for the whole system so you can discuss system wide data as appropriate If individual site information is also included it is usually just varicella-containing vaccines that must be shipped directly to the site
Question 52
5 Storage amp Handling Site Wide Dorm Style Units
Question 52 Determine whether the provider has any dorm-style units on site and answer the questions below
Note to Reviewer A dormitory-style refrigerator is a unit that has both refrigerator and freezer compartments behind a singleexterior door Dorm-style units also have an evaporator plate (cooling coil) which is usually located insidean icemaker compartment (freezer) within the refrigerator
A Does the provider have any dorm-style units that are used at any time tostore vaccines
Yes [X] No (Skip to question 53)
B Does the provider have sufficient space in existing compliant vaccinestorage units to store all vaccines without use of the dorm-style unit at any time
Yes No [X]
Review CDC Requirement
Dorm- and bar-style units are prohibited for vaccine storage Vaccines stored in dorm-style units are considered non-viable and must be returned to the centralized distributor CDC recommends the following vaccine storage unit types (in order of preference)pharmaceutical grade stand-alone or combination units (preferred) householdcommercial stand-alone unitshouseholdcommercial combination units using the refrigerator section only
Goal of this question Ensure no vaccine is stored in dorm-style units even for short periods of time Encourage them to label any units ldquoNo Vaccine Storage Allowedrdquo Vaccine stored in these units is considered non-viable If a site is using a dorm-style unit call the MnVFC program (651-201-5522)
Resource Section 8 in the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 43
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 535 Storage amp Handling Site Wide Storage Unit Space Availability
Question 53 Does the provider have sufficient room across storage units to store current stock as well as anyadditional stock acquired during peak season without overcrowding
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have sufficient storage space to accommodate vaccine stock at the busiest time of year without overcrowding
Goal of this question Ensure that sites have sufficient space in their units to maintain vaccines at the busiest time of year Overcrowding of vaccine limits air circulation and affects the unitrsquos ability to maintain stable temperatures
Helpful information bull Look for signs of overcrowding such as vaccines that are pushed up against the wall bins that are overflowing or storage units that are full during non-peak seasons
Discuss immediate actions if the unit is overcrowded Move some of their vaccines order less vaccine more frequently (once per month preferably) andor purchase another storage unit for overflow
Resource bull Section 8 MnVFC Policy and Procedure Manual
Page 44 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 545 Storage amp Handling Site Wide Expired Vaccines
Question 54 Look in each unit Are there expired vaccines in any of the vaccine storage units at this site
Answers (Choose one)
Yes [X] No
Review CDC Requirement
Vaccines should be rotated weekly and when a new shipment comes in so that longer-dated vaccines are stored behind shorter-dated vaccines If vaccines expire they can no longer be stored in the same storage unit with viable vaccines They must be placedin a container or bag clearly labeled ldquoDo not userdquo and separated from viable vaccines to prevent inadvertent use Expired vaccinemust be returned to the centralized distributor within six months of expiration
Goal of this question Ensure there is no expired vaccine in any storage unit
Helpful information bull Sites can prevent their stock from expiring by rotating vaccines every week andor when a new shipment arrives Longer-dated vaccines are stored towards the back of the unit and shorter-dated vaccines are up front
bull Pay attention to vaccines that expire within the next three months Consider transferring vaccine that will expire soon to another MnVFC-enrolled site that will use the vaccine preferably a site close by It is the transferring sitersquos responsibility to arrange the transfer of the vaccine Be sure to complete the MDH Vaccine Transfer Record form and send it to MDH If they are having difficulty finding a location to accept vaccine contact MDH
bull This is a great opportunity to educate sites about the MDH Nonviable Vaccine Form and the process for returning vaccine The VFC program does get some credit for taxes and fees on vaccine that is returned to the distribution center
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MDH Nonviable Vaccine Form and MDH Vaccine Transfer Record on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfcformshtml)
IPI Advisor Manual | February 2017 Page 45
The 2017 MnVFC Site Visit Paperwork Chapter 4
- -
-
Question 555 Storage amp Handling Site Wide Back up Thermometer
Question 55 Does the provider have a readily available back-up thermometer with a current and valid certificate ofcalibration testing
Note to Reviewer ldquoReadily availablerdquo means that the thermometer is available to perform twice-a-day monitoring for a unit asrequired CDC recommends that the back-up thermometer be maintained on site
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have a readily available back-up thermometer with a current and valid certificate of calibration testing Toprevent the certificates of calibration testing of the primary and back-up thermometers from expiring at the same time the date of calibration testing (or issue date) of the back-up thermometer should be different from the date of calibration testing (or issue date) of the primary thermometer As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meetsVFC program requirements
Goal of this question Ensure sites have one calibrated back-up thermometer onsite that is readily available in the event that the temperature monitoring device in unit fails transportation of vaccine is needed or there are other unexpected circumstances
Helpful information bull As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meets VFC Program requirements
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 56 5 Storage amp Handling Site Wide Preparation of Vaccine
Question 56 When does this provider prepare vaccine for administration to the patient
Note to Reviewer For mass vaccination clinics if one type of vaccine is offered providers may pre-draw up to 10 doses Ifusing pre-filled syringes pre-drawing also means activating the syringe by removing the needle guard orattaching a needle
Answers (Choose all that
apply)
Prepare dose immediately before administration Pre-draw doses for upcoming patients (in a regular clinicpractice) [O] Pre-draw up to 10 doses (in a mass-vaccination clinic) Pre-draw more than 10 doses (in a mass-vaccination clinic) [O] Other [O]
Review CDC Recommendation
CDC recommends preparing vaccines immediately prior to administration in order to assure viability of vaccine and prevent vaccinewastage Vaccines that are not administered immediately are at risk of exposure to temperatures outside of the required rangewhich can affect vaccine viability and ultimately can leave children unprotected against vaccine-preventable diseases
Goal of this question Discuss proper timing and preparation of vaccine(s) for administration These are recommendations not requirements
Helpful information bull Educate staff on the importance of preparing vaccine immediately before administration Pre-drawing of vaccines may lead to concerns related to vaccine viability potency sterility and wastage
Page 46 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 6 Inventory Question 61
6 Inventory Inventory Comparison
Question 61 Visually inspect storage units to determine if existing supply of vaccines proportionately mirrorspopulations served Choose the most accurate statement below
Note to Reviewer bull CDC recommends that providers maintain a four-week supply of inventory bull For this question do not take into account vaccine types that the provider does not order Here simply
make sure that overall the vaccines in the providerrsquos storage units are available in sufficient amounts toserve their patient population
Answers (Choose one)
The current vaccine inventory proportionately reflects the populations identified Only public stock is insufficient [X] Only private stock is insufficient [X] Both public and private stock are insufficient [X] Site uses the replacement method but does not appear to have enough vaccine for their population [X] Other [X]
Review CDC Requirement
VFC providers must order and stock routine vaccines in accordance with their patient population in order to prevent missedvaccination opportunities Having sufficient amounts of all stocks prevents the inadvertent use of VFC vaccines for non-VFC-eligiblepatients and vice versa
Goal of this question Assess whether the site is ordering appropriate quantities of vaccine for the population they serve at their site
Helpful information bull If the site sees 30 percent private-pay patients and 70 percent VFC the stock in their storage units should reflect that proportion If you donrsquot know you can ask the site about their population
bull This is meant to be a general assessment so in a big site if they have only a small amount of vaccine that may indicate an issue with vaccine management
bull CDC recommends smaller more frequent orders (ie monthly) rather than large orders to minimize the amount of vaccine loss if an incident occurs during shipment or in the storage unit Sites should not order more frequently than once a month
bull Sites using the replacement method will only have one stock but it should appear to be large enough for their population
bull Only assess the vaccine types that the site currently stocks in their unit We know there are sites that do not offer all ACIP-recommended vaccines for various reasons That issue will be addressed in question 62
IPI Advisor Manual | February 2017 Page 47
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 626 Inventory ACIP Recommended Vaccines
Question 62 Review providerrsquos current inventory to answer the questions below
A Does the provider offer all routine ACIP-recommendedvaccines for their patient population
Yes (Skip to question C) No [X] Offers all except varicella because direct ship ofvaccine is unavailable from manufacturer
B Which routine vaccines are NOT being offered DTaP Hepatitis A Hepatitis B HIB HPV Influenza Meningococcal
MMR Pneumococcal Polio Rotavirus TdapTd Varicella
C According to Immunization Program Policy does theprovider make accessible all non-routine ACIP-recommended vaccines for those VFC patients whomeet the criteria for receiving them
Yes (Skip to question 63) No [X]
D Which non-routine vaccines are NOT being offered Pneumococcal polysaccharide vaccine (PPSV23) Meningococcal Group B (MenB) Other
Review CDC Requirement
VFC providers agree to comply with immunization schedules dosages and contraindications that are established by the Advisory Committee on Immunization Practices (ACIP) for the vaccines identified and agreed upon in the Provider Agreement UNLESS bull In the VFC providers medical judgment and in accordance with accepted medical practice the VFC provider deems such
compliance to be medically inappropriate for the child bull The particular requirements contradict state law including laws pertaining to religious and other exemptions The VFC program entitles children to the following vaccines DTaP Hepatitis A Hepatitis B HIB HPV Influenza MeningococcalMMR Pneumococcal Polio Rotavirus TdapTd and Varicella VFC providers are also required to ensure that VFC-eligible children have access to non-routine vaccines as needed
Goal of this question Assess if the site is offering all the ACIP-recommended vaccines for the population they serve and these vaccines are in stock on the day of the visit It is important that every MnVFC-eligible child that comes to a providerrsquos office for an immunization is vaccinated
Helpful information bull The Advisory Committee on Immunization Practices (ACIP) is a group of medical and public health experts that develops recommendations on how to use vaccines to control diseases in the United States
bull Specialty providers are not required to offer all routine vaccines but should provide the vaccines appropriate for their population
bull If the site does not offer all routine ACIP-recommended vaccines appropriate for their population check the ldquoNordquo box in Part A then check the appropriate box(es) in Part B for any vaccines not offered Please contact MDH as this situation offers us the opportunity to provide education to the site
bull For non-routine vaccines they must either be in stock or the site must have an alternative protocol in the routine management plan that ensures these children have access when applicable
Resources bull IAC Diseases and Vaccines (wwwimmunizeorgvaccines) bull CDC Advisory Committee on Immunization Practices (ACIP) (wwwcdcgovvaccinesacipindexhtml)
Page 48 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 636 Inventory Separation of Stock
Question 63 Observe how the provider differentiates stock in each storage unit to answer the questions below
A Is it clear which vaccines belong to public stock andwhich belong to private stock
Yes No [X] Not applicable replacement site
B Is it clear which vaccines belong to VFC stock andwhich belong to UUAV stock
Yes No [X] Not applicable replacement site Not applicable not UUAV-enrolled site
Review CDC Requirement
In order to ensure that VFC vaccines are only administered to VFC-eligible children VFC providers that serve both VFC and non-VFCshyeligible children must maintain their vaccine inventories in such a way that they can clearly differentiate public stock from privatestock as well as VFC from other public stock
Goal of this question Assess whether the site can distinguish between MnVFC vaccine and private vaccine If they participate in the Uninsured and Underinsured Adult Vaccine (UUAV) program they should also be able to distinguish between MnVFC stock and UUAV stock Some sites use labels bins boxes etc to differentiate their stock If it is not clear how the site differentiates their stock discuss vaccine management with the staff For follow-up call MDH to discuss doing a follow-up site visit
Sites using the replacement method will not have separate stocksmdashthis is an approved alternative method for keeping track of vaccine
Resource bull Section 10 of the MnVFC Policy and Procedure Manual
IPI Advisor Manual | February 2017 Page 49
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
MnVFC Site Visit Storage and Handling Per Unit Answer Sheet 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet MnVFC PIN ___________________
Question number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
Temperature Monitoring Device Questions Questions 43 47 must be answered separately for the freezer and refrigerator if the unit is a combo Be sure to document responses in the appropriate column
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
All the questions on the Site Visit Storage amp Handling Per Unit Answer Sheet have been discussed previously in section 4 of this manual Use this sheet to record information about all the units at the site visit You will need one sheet for each unit If it is a combination unit (either pharmaceutical or household) you can record both sections on one sheet If they have stand-alone units use one sheet for each unit Do not enter the answers to the questions in section 4 of the questionnaire
If you need more information about any of the questions refer back to the main questionnairemdashthe complete question additional guidance including notes to the reviewer and the CDC requirements are there Also if the site is not meeting the requirement you will go back to the questionnaire to complete the ldquoActions if Non-compliantrdquo section including the root cause analysis and follow-up sections
When you have completed the assessment of all the storage units remember to go back to the questionnaire to complete sections 5 and 6
Page 50 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
ndash
ndash
MnVFC Provider Follow-up PlanThe goal of the Provider Follow-up Plan is to communicate with the site all of the VFC requirements any unmet requirements found during your site visit and the timeline for completing the required action The left hand column is a box to check for ldquoUnmetrdquo requirements
Helpful information bull The form can be used to review what the site is doing well and what they need to work on
bull For requirements that have specific documentation that needs to be sent to you use the notes section
2017 MnVFC Provider Follow-up Plan Site _______________________________________________ MnVFC PIN ____________ Date of Visit ___________
Thank you for participating in this MnVFC compliance site visit Please review this visit summary including follow-up actions and timelines for completion Unmet MnVFC requirements and recommendations have a checked box next to them The goal of this plan is to support you with successfully implementing the program and improving access to vaccines for VFC-eligible children
Unmet Question VFC Requirements Section 1 Changes to Key Staff
Q12 Change in the Medical Director Immunization Manager Vaccine Coordinator or back-upKey Staff must be communicated to the immunization program by emailing healthmnvfcstatemnus Changes Notes
Q12 Key staff must complete the annual training on VFC program requirements and print theAnnual Training certificate of completion Documentation Required Action
Staff that have not completed the MnVFC online training must complete it and send acopy of the certificate to the reviewer Training can be found on the MnVFC website (wwwhealthstatemnusvfc) Due date 1 month
Notes
Unmet Question VFC Requirements Section 2 Eligibility
Q21 Provider staff must possess a working knowledge of all VFC eligibility criteria and use thoseVFC Eligibility criteria to screen children prior to administering VFC vaccines
Categories Notes
bull This form provides documentation needed for follow-up actions when you send your thank you email
The second to last page of the Provider Follow-up Plan has a summary of the MnVFC program recommendations These are to remind the site about best practices they may want to improve upon even though they are not yet requirements of the program For example you could discuss the recommendation about storage units if they currently have a combination household unit and are using both sections
The last section is for your signature and the person you met with In most sites it will be the immunization manager or vaccine coordinator who signs the form unless the medical director attended the site visit You keep the original copy and the site will need to keep a copy for themselves
To be completed by the site visit reviewer
I acknowledge that a VFC site visit was performed on __________________ (visit date) The follow-up plan which includes a list of all current VFC program requirements and recommendations assessed during the visit and any required follow-up actions was provided at the end of the visit
Site visit reviewer
Phone
Reviewer Signature Date
To be completed by the provider
I acknowledge that our practice took part in the VFC site visit noted above I understand the findings of the visit and any required actions that must be taken by our office in order to meet VFC program requirements
Medical Director (or designee) Name Title
Medical Director (or designee) Signature Date
IPI Advisor Manual | February 2017 Page 51
The 2017 MnVFC Site Visit Paperwork Chapter 4
After the Site Visit Send a thank you email highlighting the unmet requirements documents you need from the site to resolve the issue(s) and the date you need them Make sure to include the link to the Site Visit Survey (httpssurveyvovicicomseashxs=56206EE334CE0B14)
Please refer to Chapter 3 for more information about future follow-up required after the visit including forms and documentation
Resource bull Sample Thank You letter on IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml)
Chapter 5
IPI Advisor Resource List MnVFC Program 651-201-5522
MnVFC wwwhealthstatemnusvfc
bull Separate Stock and Replacement Method Policies and Procedures Manuals bull Online trainings bull MnVFC Announcements sign up to receive them via email bull Ordering MDH vaccine bull MnVFC forms Screening forms Reporting forms Others MDH Nonviable Vaccine Form MDH Vaccine Transfer Record and Vaccine Borrowing Report
bull MnVFC promotional materials bull Immunization Billing Guidance for MnVFC and Immunization Billing Guidance for MnVFC Replacement Sites Immunization Practices Improvement Program (IPI) wwwhealthstatemnusdivsidepcimmunizeipi
bull IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml) bull IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml) IPI Resource Folder Contents (wwwhealthstatemnusdivsidepcimmunizeipiipifolderpdf)
Minnesota Immunization Information Connection (MIIC) wwwhealthstatemnusmiic
bull MIIC regions and regional coordinators
Clinical Practice MDH Immunization Program wwwhealthstatemnusimmunize
Got Your Shots News wwwhealthstatemnusdivsidepcnewslettersgys
MDH Immunization Information for Health Care Providers wwwhealthstatemnusdivsidepcimmunizehcp
bull Got Your Shots A Providers Guide to Immunization in Minnesota bull Vaccine protocols bull Forms for tracking patient immunizations bull Immunization schedules for Health Care Providers Immunization Action Coalition (IAC) wwwimmunizeorg
bull Ask the Experts bull VISs (Vaccine Information Statements and translations) bull Administration screening questions bull Medical management of vaccine reactions bull Order form for Californiarsquos Immunization Technique DVD Best Practices with Infants Children and Adults
Page 52 IPI Advisor Manual| February 2017
IPI Advisor Resource List Chapter 5
CDC ldquoPink Bookrdquo wwwcdcgovvaccinespubspinkbookindexhtml
CDC Advisory Committee on Immunization Practices (ACIP) wwwcdcgovvaccinesacip
CDC Vaccines and Immunizations wwwcdcgovvaccines
VAERS reporting httpvaershhsgovindex
Storage and Handling Got Your Shots Providers Guide ndash Managing Vaccine wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml
MnVFC Guide to Temperature Monitoring Devices wwwhealthstatemnusvfc
MDH Clinicianrsquos Vaccine Mishap Checklist wwwhealthstatemnusdivsidepcimmunizeipivaxchklstpdf
MDH Vaccine Storage Guide wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml
CDC Vaccine Storage and Handling Toolkit wwwcdcgovvaccinesrecsstoragetoolkit
You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Vaccine manufacturer phone numbers wwwcdcgovvaccinespubspinkbookdownloadsappendicesFcontact-info-manufactpdf
IAC Checklist for Safe Vaccine Handling and Storage wwwimmunizeorgcatgdp3035pdf
IAC Donrsquot Be Guilty of These Errors in Vaccine Storage and Handling wwwimmunizeorgcatgdp3036pdf
Additional Resources Print materials from MDH ndash order forms wwwhealthstatemnusdivsidepcimmunizeordermathtml
Vaccine Education Center ndash Childrenrsquos Hospital of Philadelphia wwwchopeduservicevaccine-education-centerhomehtml
California Department of Public Health ndash Interactive training on vaccine administration and storage and handling handout on transporting vaccine and how to package wwwezizorg
IPI Advisor Manual | February 2017 Page 53
IPI Advisor Resource List Chapter 5
CDC vaccine price list wwwcdcgovvaccinesprogramsvfcawardeesvaccine-managementprice-listindexhtml
Vaccine Information Statements (VIS) wwwcdcgovvaccineshcpvisindexhtml
CEU Opportunities CDC Immunization Education and Training wwwcdcgovvaccinesedindexhtml
Immunization You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Page 54 IPI Advisor Manual| February 2017
- Introduction
-
- Welcome to the Immunization Practice Improvement (IPI) Program
- Contact Information
-
- Chapter 1
- Requirements to Participate in the MnVFC Program
- Vaccines for Children Program
- Chapter 2
- Reimbursement for MnVFC Visits
- Types of Visits
- Your MnVFC Clinical CoordinatorPlanner
- New IPI Advisor Training Requirements
- Your Role as an IPI Advisor
- Reasons MDH Would Do All or Part of a Visit
- Chapter 3
- Future follow-up
- Conducting the Visit
- Preparing for the Visit
- Information for the Visit
- Site Visit Checklist
- Scheduling the Visit
- Chapter 4
- After the Site Visit
- MnVFC Provider Follow-up Plan
- MnVFC Site Visit Storage and Handling Per Unit Answer Sheet
- Section 6 Inventory
- Section 5 Storage amp Handling Site-Wide
- Section 4 Storage amp Handling Per Unit
- Section 3 Documentation
- Section 2 Eligibility
- Section 1 Provider Details
- The Site Visit Reviewer Legend
- MnVFC Site Visit Questionnaire
- Required Paperwork for Site Visits
- Chapter 5
-
Page 24 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 3 Documentation Question 31
3 Documentation Eligibility Screening amp Documentation
Question 31 To answer the questions below the provider must clearly demonstrate the patient intake processReview a minimum of 10 records that contain an immunization visit within the last 6 ndash 12 months
Note to Reviewer Criteria for Record Selection 1) Record selection must be completely random and the provider must not know prior to the visit which
records will be reviewed 2) Patient must have been 0-19 years of age at the last visit (Note Records of 19-year-old patients may
allow you to see if VFC vaccines are being used beyond the allowable age) 3) Must review a mix of public and private-pay patients (if applicable)
A Does the provider have a process that ensures that patients are screened forVFC eligibility at each visit and that screening results are documented at each visit
Yes No [X] (If no skip question F)
B Does the providerrsquos process ensure that staff administering vaccine know which vaccine stock to select from prior to drawing the vaccine
Yes No [X]
C Number of records reviewed If fewer than 10 records are reviewed select the reason why Provider does not have 10 patient records with immunizations in last 12 months
D Do all records contain date of the immunization visit and patientrsquos date of birth Yes No [X]
E Do all records contain the patientrsquos specific eligibility status associated with thedate of the immunization
Yes No [X]
F Do any of the providerrsquos records contain any evidence that the patient received vaccine for which they were not eligible
Yes [X] No
Review CDC Requirement
VFC providers must screen for and document VFC eligibility at each immunization visit Documentation must include the date of the visit and the childrsquos specific eligibility category VFC providers must use screening results to ensure that only VFC-eligible children receive VFC vaccine and that administration fees are billed for as appropriate Eligibility status must be readily available to staff administering vaccine prior to selecting which vaccine stock to use
Goal of this question Ensure the site is screening for eligibility and documenting the eligibility category in the medical record
Review a minimum of 10 records from within the last 6-12 months where the patient received an immunization You must review a mix of public and private pay patients (if applicable)
Random selection is important If the staff have pre-selected records for review do not use and identify additional randomly selected records to review
Helpful information bull Discuss upgrading the electronic health record to make documentation of VFC eligibility screening a required field Documenting eligibility screening in the immunization field promotes better MIIC data
bull Q 31 B Sites using the replacement method of vaccine management only have one stock so you will answer ldquoYesrdquo to this question
Resources bull Patient Eligibility Screening Record on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfcformshtml)
bull Section 1 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 25
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 32
3 Documentation Vaccine Dose Documentation
Question 32 Review a minimum of 10 patient immunization records from the last six months (or 12 months ifnecessary) to assess compliance with documentation requirements set forth by Statute 42 US Code 300aa-25 (See note to reviewer below)
Note to Reviewer Criteria for Record Selection 1) Record selection must be completely random the Provider must not know prior to the visit which records
will be reviewed 2) Patient must have been 0-19 years of age at the last visit (Note Records of 19-year-old patients may allow
you to see if VFC vaccines are being used beyond the allowable age)
Records are Compliant if they Contain ALL the Below Elements
bull Address of clinic where vaccine was administered bull Publication date of VIS bull Name of vaccine administered bull Name of vaccine manufacturer bull Date vaccine was administered bull Lot number bull Date VIS was given bull Name and title of person who administered the
vaccine
A Number of records reviewed
B Number of records that contain ALL required documentation elements
If fewer than 10 records are reviewed select the reason why Provider does not have 10 patient records with immunizations in last 12 months
[X] Follow-up isrequired if one ormore records do not meet requirements
Goal of this question Assess whether the site is documenting all required information in each patientrsquos medical record for every vaccine dose administered in accordance with the National Childhood Vaccine Injury Act
Resources bull Section 6 of the MnVFC Policies and Procedures Manual bull National Vaccine Injury Compensation Program (wwwhrsagovvaccinecompensation)
Question 33
3 Documentation Record Retention
Question 33 Is the provider able to demonstrate (preferred) or clearly describe how they maintain historical VFCeligibility documentation for three years
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers are required to maintain all records related to the VFC program for a minimum of three years (or longer if requiredby state law) and upon request make these records available for review VFC records include but are not limited to VFC screening and eligibility documentation billing records medical records that verify receipt of vaccine vaccine ordering records and vaccinepurchase and accountability records
Goal of this question Make sure the site understands they are required to keep all MnVFC screening documentation for at least three years either electronically or on paper This information should be available to you at the time of the visit and future visits
Resource bull Section 7 of the MnVFC Policies and Procedures Manual
Page 26 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 34
3 Documentation Borrowing Documentation
Question 34 Discuss borrowing practices with the provider to answer the questions below
Note to Reviewer bull To be considered ldquofully documentedrdquo documentation for each borrowed dose must include thefollowing information
Vaccine type borrowed Date the dose was administered Stock used (VFC or private) Reason appropriate vaccine stock was not used Patient name and date of birth Date dose was returned to appropriate stock
A Did the provider state that they had borrowed any vaccines (whetherdocumented or not) since the last VFC Compliance Site Visit
Yes No (If no skip to question 36)
B Are there any doses for which there is no documentation (ie provider hasindicated that doses were borrowed but cannot verify how many or why)
All doses are documented Some doses are not documented [X] No doses are documented [X] (if nodoses documented skip toquestion 36)
C Were all borrowed doses fully documented (See Note to Reviewer above) Yes No [X]
D Were all borrowed VFC doses either replaced or an order submitted to replacethe doses Yes No [X]
Review CDC Requirement
VFC providers are expected to maintain an adequate inventory of vaccine for VFC and non-VFC-eligible patients It is theresponsibility of the VFC provider to appropriately schedule and place vaccine orders VFC providers must also rotate stock to ensure timely use of short-dated vaccines Borrowing of vaccine between private and public inventories must be a rare unplanned occurrence and cannot serve as a replacement system for a VFC providerrsquos privately purchased vaccine inventory All instances ofborrowing must be properly documented reported and replaced
Goal of this question Assess vaccine accountability by verifying that children are receiving vaccine from the appropriate stock
Borrowing is when a fully insured child receives a dose of MnVFC vaccine or a MnVFC-eligible child receives a dose of private vaccine This should be a rare unplanned occurrence The site must document any borrowing of vaccine between stocks ideally on the VFC Borrowing Report Form If they are not currently using the form review it with them and encourage them to post it close to their vaccines It does not need to be sent to MDH but should be kept for 3 years and filed with their MnVFC documents to be reviewed whenever they have a regular or unscheduled (unannounced) site visit
Helpful information bull Understand and report on staffrsquos verbal (ie anecdotal) accounts of borrowing obtained during the visit Often sites do not know that what they do is considered borrowing or they think borrowing is acceptable and documentation isnrsquot needed so long as those vaccines are eventually replaced
bull Since sites using the replacement method only have one stock of vaccine they very rarely borrow bull This question asks for future follow-up in 6 months Make a note on your calendar and ask them to send you a copy of their borrowing reports for the previous 6 months with documentation of doses borrowed and replaced We will remind you if we donrsquot hear from you at the 6 month time frame Complete the Follow-up Form and attach the borrowing form
Resources bull Vaccine Borrowing Report on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfc formshtml)
bull Section 10 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 27
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 353 Documentation Borrowing Reasons
Question 35 Based on your discussion with the provider and a review of borrowing reports document the dosesborrowed for each reason and answer the questions below
Note to Reviewer bull Short-dated vaccines are doses that are likely to expire before they can be used bull Exchanging short-dated vaccines should only occur in practices that have a small number of private
patients
A Reasons for Borrowing a VFC Dose (Enter the number of _____ Private vaccine shipment delay (order placed on time but delay in shippingreceipt)
vaccine doses borrowed for each
reason in the spaces
_____ Private vaccine not useable on arrival (vials broken temperature monitor out of range) _____ Ran out of private vaccine between orders (provider orders not placed on time) [X]
provided) _____ Short-dated private dose was exchanged with VFC stock _____ Accidental use of VFC dose for a private patient (human error) _____ Replacement of private dose with VFC when insurance plan did not cover vaccine _____ OtherDocumented dose did not include reason for borrowing [X]
(Explanation Required) Reasons for Borrowing a Private Dose _____ VFC vaccine shipment delay (order placed on time but delay in shippingreceipt) _____ VFC vaccine not useable on arrival (vials broken temperature monitor out of range) _____ Ran out of VFC stock between orders (provider orders not placed on time) [X] _____ Short-dated VFC vaccine dose was exchanged with private dose _____ Accidental use of a private dose for a VFC-eligible patient (human error) _____ OtherDocumented dose did not include reason for borrowing [X]
(Explanation Required)
B Enter date range for instances of borrowing reviewed in the borrowing report Note If ldquoDate of earliest instancerdquo is not available use the date of the last VFC Compliance Visit If ldquoDate of last instancerdquo is not available use the date of thecurrent VFC Compliance Visit
Date of earliest instance
Date of last instance
C Does borrowing appear to be a routine practice Note To determine whether borrowing is a routine practice assess frequency of and repeating reasons for borrowing Examples Frequent accidental use of incorrect stock exchanging short-dated vaccines or issues with ordering and shipment
Yes [X] No
Goal of this question Determine the reasons why the site is borrowing vaccine
If sites are using the Vaccine Borrowing Report review the reasons for borrowing to help document borrowed VFC andor private doses If they have not been documenting borrowing on this report (or any other form) estimate their borrowing practices If you do not know the date range for their borrowing use the last site visit date to the current visit date The use of ldquootherrdquo as the reported reason for borrowing should be rare if ever and would require explanation and follow up
Helpful information bull Look to see if they routinely maintain insufficient amounts or types of vaccine to support their public and private patients that leads to borrowing
bull Pay attention to borrowing cases documented as ldquoaccidentalrdquo Repetitive accidental borrowing may indicate an issue with ordering processes or insufficient staff training
bull Borrowing is not a place to document wasted or lost doses bull The time period of the borrowing may give you clues about the root cause Were the borrowed doses concentrated in a short period or spread out across several months or a year Are all vaccine types being borrowed or just one
bull If borrowing seems to be an issue discuss vaccine management ordering procedures
Resources bull Vaccine Borrowing Report on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfc formshtml)
bull Section 10 in the MnVFC Policies and Procedures Manual
Page 28 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 36
3 Documentation Vaccine Management Plan
Question 36 Physically review the providerrsquos Vaccine Management Plan to answer the question below
A Does the provider have a Vaccine Management Plan Yes No [X] (If no skip to question 37)
B Does the plan list the current Immunization Manager Vaccine Coordinator andback-up
Yes No [X]
C Does the plan address proper vaccine storage and handling practices Yes No [X]
D Does the plan specify vaccine receiving procedures Yes No [X]
E Does the plan contain procedures for what to do with vaccine in the event of an emergency
Yes No [X]
F Does the plan contain procedures for vaccine ordering Yes No [X]
G Does the plan address inventory control (example stock rotation) Yes No [X]
H Does the plan address how to handle vaccine wastage Yes No [X]
I Does the plan address staff training and documentation on vaccine managementstorage amp handling
Yes No [X]
J Does the plan contain a review date that falls within the last 12 months Yes No [X]
K Has the plan been signed by the individual responsible for its content Yes No [X]
Review CDC Requirement
VFC providers must develop maintain and implement a Vaccine Management Plan for routine and emergency vaccinemanagement The plan must contain the current Vaccine Coordinator and back-up proper storage and handling practicesshipping and receiving procedures emergency procedures procedures for vaccine ordering inventory control (eg stock rotation)how to handle vaccine wastage and staff trainingdocumentation on vaccine management storage and handling The plan must bereviewedupdated annually or more frequently if changes occur A ldquoreview daterdquo and signature are required on all plans in order tovalidate that they are current
Goal of this question Evaluate the sitersquos plan for vaccine management It is especially important that they have a plan for emergency management of their vaccine in the case of equipment failure or power outage Encourage all sites to read and sign the MnVFC Policies and Procedures Manual and complete the emergency plan or be able to show you a plan of their own
If the provider is not able to physically show you the plan at the time of the visit or if the recorded review date is not within the last 12 months you must mark that this requirement is unmet The Vaccine Management Plan is important in times of emergency and it should be easy to access by any staff member at any time Encourage them to post the plan and put a copy with the packing supplies
Helpful information bull Encourage the site to fill in the ldquoImmunization Managerrdquo and ldquoVaccine Coordinatorrdquo fields in the
MnVFC Policies and Procedures Manual for their own referencebull The emergency plan in the manual can be reviewed from last year and included in this yearrsquos manual (with an updated signature and date) if there have not been any changes
bull If information in the plan is outdated site staff will not be well equipped to safely manage vaccines in the event of a power-outage or other emergency situation
bull If their institutional policy is only reviewed and updated every 3-4 years (as many are) the staff may need to sign the MnVFC Polices and Procedure Manual to meet this requirement
Resource Routine Vaccine Management Plan and Emergency Vaccine Management Plan in the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 29
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 37
3 Documentation VIS amp VAERS
Question 37 Review the providerrsquos Vaccine Information Statements (VISs) and discuss providerrsquos VAERS process toanswer the questions below
A Does the provider have readily available up-to-date VISs for all ACIP-recommendedvaccines relevant to the populations it serves
Yes No [X]
B Does the provider make a VIS available for patientsparents before eachvaccination
Yes No [X]
C Does the provider know how and when to report clinically significant adverseevents using VAERS
Yes No [X]
Review CDC Requirement
VFC providers are required to distribute the current Vaccine Information Statements (VIS) each time a vaccine is administered and maintain records in accordance with the National Childhood Vaccine Injury Act (NCVIA) which includes reporting clinicallysignificant adverse events to the Vaccine Adverse Event Reporting System (VAERS) For a list of current VISs visit CDCrsquos Vaccine Information Statements (httpwwwcdcgovvaccineshcpvis) website
Gal of this question Ensure the site has the most current VISs and is giving them to each patientparent before administering the vaccine in compliance with the federal law Parents must be educated about the vaccine their child will receive and be aware of possible contraindications and side-effects in order to make well-informed decisions about their childrsquos health
Helpful information bull Ask to see the sitersquos VISs to determine if they have an active protocol for giving VISs to parents Review to make sure they are current Ask if they know where and how to report vaccine adverse events
Resources bull Section 3 in the MnVFC Policies and Procedures Manual bull CDC Vaccine Information Statements (wwwcdcgovvaccineshcpvisindexhtml) Site may sign up for email updates for the current list of VIS publication dates for the most up-to-date version
bull IAC Itrsquos Federal Law You must give your patients current Vaccine Information Statements (wwwimmunizeorgcatgdp2027pdf)
bull VAERS (httpsvaershhsgovindex)
Question 38
3 Documentation Anaphylaxis protocol
Question 38 Does the site have an anaphylaxis protocol which is clearly posted near the emergency kit
Answers (Choose one)
Yes No [X]
Review CDC Requirement
An anaphylaxis protocol must be clearly posted in the area where vaccines are administered
Goal of this question Make sure site is prepared for a severe allergic or anaphylactic reaction to a vaccine
Resources bull Section 11 in the MnVFC Policies and Procedures Manual bull IAC protocols Child and Teens (wwwimmunizeorgcatgdp3082apdf) and Adults (wwwimmunize orgcatgdp3082pdf)
Page 30 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
i
i i i - li i i i i i l
Section 4 Storage amp Handling Per Unit The goal of this section is to assess vaccine storage
2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet practices in each unit at the site MnVFC PIN ___________________
The 2017 MnVFC Storage amp Handling Per Unit Answer Sheet is a worksheet to document the answers to the questions in this section for each unit (combination or stand-alone) Fill in the answers to the questions in Section 4 on the answer sheet not in the questionnaire
The answer sheet has an abbreviated form of each question If you need further information on that question refer back to the full questionnaire Also if you find an area where the site is not meeting the requirements you will need to go back to that question on the 2017 MnVFC Site Visit Questionnaire to complete ldquoActions if Non- compliantrdquo section including the root cause analysis and follow-up sections If there is a problem in more than one unit make a note on the questionnaire which unit you are referring to in the Notes section
Important You must fully assess any unit that may be used to store VFC vaccines even if there are no VFC vaccines there on the day of the visit If there are no vaccines and the site is not documenting twice a day temperatures discuss the need to ensure the unit is maintaining stable temperatures by monitoring for one week before placing vaccines in the unit
Quest on number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
for the freezer and e co umn
Temperature Monitoring Dev refr gerator f the un
ce Quest ons Quest ons 4 3 4 7 must be answered separate y t s a combo Be sure to document responses n the appropr at
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
44D Data downloaded and reviewed routinely (eg weekly)
Yes No [O]
Yes No [O]
45A Certificate of Calibration Testing Yes No [X]
Yes No [X]
45B Date of calibration
45C Date certificate expires [X] Follow-up is required if expired [X] Follow-up is required if expired
45D Certificate contains all necessary items
Yes No [X]
Yes No [X]
46 Probe properly placed Yes No [X]
Yes No [X]
47A Two temperature readings per day
Yes No [X]
Yes No [X]
47B Time date and name (or initials) for each reading
Yes No [X]
Yes No [X]
47C Current temperature and minmax temperatures (if
Current ________deg Minimum ________deg Maximum _deg
Current ________deg Minimum ________deg Maximum _deg
Sections 5 and 6 contain questions about storage and handling site wide and inventory It is helpful to keep those questions in mind as you assess the individual storage units Think about dorm-style units expired vaccine vaccine supply room for vaccine stocking all the recommended vaccines and separation of stock if appropriate
NOTE The sections that follow require reviewers to validate responses by looking at vaccine storage units temperaturemonitoring equipment and the vaccine inventory inside a unit bull For section 4 use a separate Storage amp Handling Per Unit Answer Sheet for each unit to document the findings (combination
units using both sections can be documented on the same answer sheet) bull When an unmet requirement is identified return to this questionnaire to complete the ldquoActions if Non-compliantrdquo section for
that question bull After you complete one answer sheet for each unit return to the questionnaire to complete sections 5 and 6 using information
you gathered while assessing the units The questions in sections 5 and 6 (Storage amp Handling Site-Wide and Inventory) are notunit-specific but do require that the response be based on a thorough assessment of all the providersrsquo units
4 Storage amp Handling Per Unit
Description On the Storage amp Handling Per Unit Answer Sheet place a name that will allow you or someone else from your program to easily identify this unit in the event of follow-up We recommend using Brand + Location(example Samsung - Room 123) Save each Storage amp Handling Per Unit Answer Sheet with the Brand + Location in the file name
(example SamsungRoom123doc)
IPI Advisor Manual | February 2017 Page 31
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 41
4 Storage amp Handling Per Unit Storage Unit Build amp Use
Question 41 Below select the build and use of the vaccine storage unit you are assessing
Note to Reviewer Dorm-style units Do not add dorm-style units here Dorm-style units will be addressed in section 5 Units storing only private stock You must review these storage units even if they contain only private stockat the time of the visit because that vaccine could be administered to VFC patients
A What type of unit is this A Stand-alone B Combination
B Select use if stand-alone A Freezer B Refrigerator
Select use if combination A Use both sections to store vaccine B Use freezer section only to store vaccine C Use refrigerator section only to store vaccine
Goal of this question Identify the unit you are evaluating The description asks you to create a unique name for this unit so that you will be able to identify the same unit in future site visits Put this description on the top of the answer sheet (ie make and location)
Helpful information bull A stand-alone unit is either a refrigerator or a freezer It does not have both sections in the unit bull If there is a combination unit note if the site uses both the refrigerator and freezer or only one section of the unit to store vaccines CDC does not recommend the use of either section or the freezer section only of combination household units
bull If your site utilizes the separate stock method of vaccine management you must review storage units even if they contain only private stock at the time of the visit because there is a chance that those vaccines could be administered (borrowed) to VFC-eligible patients
Page 32 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 424 Storage amp Handling Per Unit CDC Recommended Storage Units
Question 42 Below document the grade of the vaccine storage unit you are assessing
Note to Reviewer Pharmaceutical Also called ldquopurpose-builtrdquo these units are designed by the manufacturer specifically tostore vaccines or other biological materials Commercial Although usually intended to store food and beverages commercial units are often larger and more powerful than the household units found in most homes Though these units are intended to meet thehigher demands of larger facilities these units are not specifically built for the storage of biologicalmaterials Household (non-commercialdomestic) These units are usually smaller than commercial units and areintended for use in small offices and in homes ndash typically for food storage However just like commercialunits they are not designed specifically for the storage of biological materials Such units are usually available in common home supply stores
Answers (Choose one)
Select grade A Pharmaceutical B CommercialHousehold
[O] CDC does not recommend the use of both sections or the freezer section only of combination commercialhousehold units
Review CDC Recommendation
CDC recommends the following vaccine storage unit types (in order of preference) pharmaceutical grade stand-alone orcombination units (preferred) householdcommercial stand-alone units householdcommercial combination units using therefrigerator section only
Goal of this question Assess the grade and type of each storage unit bull Pharmaceutical grade units may be stand-alone or combination units that are often metal may have glass in the door for viewing inside often have an external digital temperature display and are manufactured by medical companies
bull Commercial or household units often look like your kitchen appliance have vegetablemeat drawers in the unit and are manufactured by household appliance companies
bull Occasionally you might find a medical grade unit which is usually a commercialhousehold unit with a lock and 3-prong plug These are still considered household units because of their ability to maintain proper temperatures and air flow Studies show that household stand-alone units are better able to maintain consistent temperatures than their combination counterparts Combination household units used to store vaccine in both sections of the unit is no longer recommended and may be prohibited in the future Combination household storage units that are having difficulty maintaining a cold enough freezer temperature and a warm enough refrigerator temperature should be replaced or a separate stand-alone freezer should be purchased
For frozen vaccines the most cost effective solution is for the site to purchase a small stand-alone freezer The site may need time to budget for a stand-alone storage unit
Resources bull Replacing Combination Household Units Tip Sheet on IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml)
IPI Advisor Manual | February 2017 Page 33
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 434 Storage amp Handling Per Unit Temperature Monitoring Device in the Unit
Question 43 Determine whether there is a temperature monitoring device in this section of the storage unit andanswer the questions
A Is there a temperature monitoring device in this section of thestorage unit
Yes No [X] (If no skip to question 47)
B Who is responsible for supplying the temperature monitoring device in this section of the storage unit Provider
Review CDC Requirement
Certificates of calibration testing provide confidence that the temperature monitoring device is measuring temperaturesaccurately All units storing VFC vaccines must have a calibrated temperature monitoring device with a current and valid certificateof calibration testing All certificates must contain modeldevice name or number serial number date of calibration testing (report or issue date) and Instrument Passed testingInstrument in Tolerance (Recommended uncertainty = +-05ordm C (+-1ordm F))
Goal of this question Assess whether there is a temperature monitoring device in the unit If the unit is not being monitored at all call MDH at 651-201-5522 for guidance
Helpful information bull This question does not ask whether the temperature monitoring device is working or the characteristics of the device These issues will be addressed later in the questionnaire
bull For part B the provider is always responsible for supplying the temperature monitoring device Even if their thermometer or data logger was originally from MDH it is their responsibility to ensure it is functional and calibrated
Resources bull Section 8 in the MnVFC Policies and Procedures Manual
Page 34 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 444 Storage amp Handling Per Unit CDC Recommended Temperature Monitoring Device
Question 44 Assess the temperature monitoring device in this section of the storage unit to answer the questionsbelow
A Is the temperature monitoring device a continuous monitoring and recordingdevice (eg data logger)
Yes No [O] (Skip D)
B Does the temperature monitoring device have a probe in buffered material Yes No [O]
C Does the temperature monitoring device have a digital display that can beeasily read from the outside of this unit
Yes No [O]
D Is data downloaded and reviewed routinely Yes No [O]
Review CDC Recommendation
As of Jan 1 2018 all VFC providers must use continuous temperature monitoring devices (eg data loggers) to monitor vaccinesthat will be administered to VFC-eligible children Routine review and accessibility of temperature data is critical for determining whether vaccine has been properly stored and for assessing usability of vaccine that was involved in a temperature excursion Tomeet VFC Program requirements the device must also be equipped with bull A temperature probe bull An active temperature display that can be easily read from the outside of the unit bull The capacity for continuous monitoring and recording capabilities where the data can be routinely downloaded
The following are additional recommended features for these devices bull Alarm for out-of-range temperatures bull Current minimum and maximum temperatures display bull Low battery indicator bull Accuracy of +- 1degF (05degC) bull Memory storage of at least 4000 readings bull User programmable logging interval (or reading rate) recommended at a maximum time interval of every 30 minutes bull Use of a probe that best reflects the temperature of the vaccine (such as a buffered probe)
Goal of this question Assess the temperature monitoring device in the storage unit Note that these are all recommendations not requirements at this time
This is a great teaching opportunity for sites who do not currently have a continuous temperature monitoring device Beginning Jan 1 2018 all units that store MnVFC vaccine will be required to have a continuous temperature monitoring device (ie a data logger or a continuous temperature monitoring system) Unlike a minmax thermometer a continuous temperature monitoring device provides detailed information on all temperatures recorded at pre-set intervals For excursions it can provide information on when a temperature went out-of-range for how long and what the temperatures were This is essential information that vaccine manufacturers need to know to assess the viability of the vaccine following an excursion
Helpful information bull Sites are required to monitor and record temperatures twice daily however temperature excursions can easily occur in the 12 hours or longer between readings Continuous temperature monitoring can help manufacturers determine vaccine viability
bull Continue to encourage sites to document and evaluate minimum and maximum temperatures the storage unit reached since the last reading and respond appropriately to out-of-range temperatures
IPI Advisor Manual | February 2017 Page 35
The 2017 MnVFC Site Visit Paperwork Chapter 4
bull It is recommended that sites download and review data weekly Discuss with sites that reviewing temperature monitoring device data also includes responding appropriately if they identify out-of-range temps
bull There is sometimes confusion about the difference between a data logger and a continuous temperature monitoring system Here are some differences
Data Loggers Continuous Monitoring Systems Have an external display similar to thermometers May or may not have an external display Have a detachable probe Probe is usually attached to transmitter Need to be plugged into the computer or cradle to download information on a regular schedule
Wirelessly sends data to computer system
Create a file of data that needs to be saved on the computer
Data is stored within the system not a separate file
Doesnrsquot allow documentation of twice a day temperature checks in the file
May allow documentation of twice a day temperature checks within the system
More about the 2018 requirement for a continuous temperature monitoring device
Required Features bull The continuous temperature monitoring device must have Continuous monitoring and recording capabilities to track and record temperatures over time The capacity to routinely download temperature data to a computer (recommended at least weekly) or wirelessly transmit data Detachable probe in a bottle filled with a thermal buffer (eg bio-safe glycol) if the data logger needs to be detached in order to download data Active temperature display
Recommended Features bull MnVFC recommends continuous temperature monitoring devices with Alarm for out-of-range temperatures Accuracy within +-1degF (+- 05degC) Low battery indicator Display of current minimum and maximum temperatures Memory storage of at least 4000 readings User programmable logging intervals (eg the user can set how often the device records the temperature)
Note that these are all currently recommendations not requirements yet
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Page 36 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 45
Goal of this question Ensure the temperature monitoring device is properly calibrated The certificate of calibration testing means that the device has been tested and it is accurately measuring temperatures within established testing limits The certificate of calibration ensures that the device meets all the required components
Helpful information bull The provider is always responsible for having a current certificate of calibration (or copy) on-site
bull To be considered ldquovalidrdquo a certificate of calibration must contain these required elements Modeldevice name or number Serial number
4 Storage amp Handling Per Unit Certificate of Calibration Testing
Review CDC Requirement
Certificates of calibration testing provide confidence that the temperature monitoring device is measuring temperaturesaccurately All units storing VFC vaccines must have a calibrated temperature monitoring device with a current and valid certificateof calibration testing All certificates must contain modeldevice name or number serial number date of calibration testing (report or issue date) and Instrument Passed testingInstrument in Tolerance (Recommended uncertainty = +-05ordm C (+-1ordm F))
Question 45
Note to Reviewer
A
B
C
D
E
Review the certificate of calibration testing for the temperature monitoring device in this section of the storage unit and answer the questions below
bull How to determine certificate of calibration testing expiration date 1) Identify the certificate issuecalibration date 2) Apply the Immunization Program-required frequency for calibration testing Example If the
issuecalibration date is 12312013 and Immunization Program policy requires testing every twoyears the expiration date is 12312015
bull Certificates must include all of the below bull ModelDevice Name or Number bull Serial Number bull Date of Calibration Testing (Report or Issue Date) bull Instrument Passed testing (Instrument in Tolerance)
Is there a certificate of calibration testing for the temperature monitoring Yes device in this section of the storage unit No [X]
What is the date of calibration for the temperature monitoring device in this section of the storage unit
What is the certificatersquos date of expiration based on ImmunizationProgram policy (See note to reviewer to determine expiration date) [X] Follow-up is required if
certificate is expired
Does the certificate contain all the necessary items listed in the Note to Yes Reviewer No [X]
Who is responsible for supplying the current and valid certificate of Provider calibration for this temperature monitoring device
Date of calibration testing (report or issue date) Note If there is no expiration date the certificate expires 2 years from the date of calibration Whether the instrument passed or failed testing (or instrument in tolerancenot in tolerance)
bull Recommended element Documented uncertainty of +- 1degF [05degC]
If these elements are present the certificate is considered valid If the certificate contains information about the recommended element or the entity that issued the certificate that is helpful but not required
To determine if a certificate of calibration testing was issued by an appropriate entity check to see if the certificate indicates one or more of these items (this is the wording used to help sites evaluate if their calibration is accurate but is not required on the certificate itself to be considered valid)
bull Conforms to ISO 17025 bull Performed by an ILACMRA Signatory body accredited laboratory You can review this list of the ILAC MRA and Signatories (httpilacorgilac-mra-and-signatories)
bull Traceable to the standards maintained by NIST bull Meets specifications and testing requirements for the American Society for Testing and Materials (ASTM) Standard E2877 tolerance Class F (le 05 degC) or better
bull Includes reference to another acceptable accuracy validation method such as comparison to other traceable reference standards or tests at thermometric fixed points
Note CDC recommends that certifications be issued for the entire monitoring unit (detachable probe data logger etc) and not individual certificates for each component
IPI Advisor Manual | February 2017 Page 37
The 2017 MnVFC Site Visit Paperwork Chapter 4
For 45 E the provider is always responsible for supplying the current and valid certificate of calibration for a temperature monitoring device
bull Tip If the temperature monitoring device has a sticker on the back with the calibration date the site can usually call the company who calibrated the device and get a copy of the certificate if they donrsquot have one
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 46 4 Storage amp Handling Per Unit Probe Placement
Question 46 Is the probe properly placed in this section of the storage unit
Note to Reviewer ldquoProperlyrdquo means that the probe in a commercial or household unit is placed in a central area of the unitdirectly with the vaccines Probes should not be placed in the doors near or against the walls close to vents or on the floor of the unit The only allowable exemption related to this requirement is for providerswho have pharmaceutical storage units (built for vaccine storage) that have either (1) a built-intemperature monitoring device OR (2) a dedicated port for the probe that dictates the placement of theprobe
Answers (Choose one)
Yes No [X]
Review CDC Requirement
The probe must be placed in a central area of the section of the storage unit directly with the vaccines in order to properly measurevaccine temperature The probe should not be placed in the door near or against the walls close to vents or on the floor of theunit For pharmaceutical units with a built-in temperature monitoring device or a dedicated port for a probe that is not in thecenter of the section of the storage unit consult your Immunization Program for guidance on placement
Goal of this question Make sure the temperature monitoring device is in the best location to accurately measure the temperature of the vaccines stored in the unit
Helpful information bull The probe of the temperature monitoring device should be placed directly with the vaccines in the middle of the unit The ONLY allowable exception is for pharmaceutical storage units that have either a built-in thermometer or a dedicated port for the probe that indicates placement of the probe
bull Temperatures can vary within the unit especially household units bull Call MDH at 651-201-5522 if you have questions
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Guide (wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml)
Page 38 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 474 Storage amp Handling Per Unit Temperature Documentation
Question 47 Review the temperature documentation over the past three months for this section of the storage unit todetermine whether the provider has a process in place for properly documenting temperatures twice aday Answer the questions below
A Are there two temperature readings recorded for this section of the storage unit per day
Yes No [X]
B Is there a time date and name (or initials) recorded for each reading Yes No [X]
C What is the current temperature and minmax temperatures (if available) inthis section of the storage unit Use the reviewerrsquos thermometer if the providerrsquos temperature monitoringdevice does not have a current valid certificate of calibration testing or the probe is not properly placed in this section of the storage unit
Current Temperature Minimum Temperature Maximum Temperature Fahrenheit Celsius
D Based on your review of the providerrsquos recent temperature documentationincluding the current temperature is this section of the storage unitmaintaining appropriate temperatures
Yes No [X] Not enough information [X]
Review CDC Requirement
Vaccines must be stored under appropriate temperatures as described in the package inserts at all times Acceptable temperature ranges vary by vaccine type and the range is 36deg F and 46deg F (2deg C and 8deg C) and for frozen vaccines the range is -58deg F and +5deg F (shy50deg C and -15deg C) Exposure to temperatures outside of those included in the package inserts could affect vaccine viability andultimately could leave children unprotected against vaccine-preventable diseases In order to maintain awareness of storage unittemperatures and ensure that vaccines are being stored at appropriate temperatures at all times VFC providers are required to monitor and document temperatures for all vaccine storage units at least twice a day Temperature documentation must contain (1) at least two temperature readings per day (2) the time and date of each reading and (3) the name (or initials) of the personwho assessed and recorded the readings CDC also recommends that VFC providers record the minimum and maximumtemperatures of each unit once each workday (preferably in the morning)
Goal of this question Ensure the temperature is being monitored twice daily is within the required range and documented correctly Use your thermometer to check the temperature if the sitersquos temperature monitoring devicersquos probe is not properly placed or there is not a current certificate of calibration Place your thermometer in the unit at the beginning of the visit to allow sufficient time to reach an accurate temperature The purpose of using your thermometer is to ensure the vaccine is being stored at the proper temperature not to ldquovalidaterdquo their reading
Question 47 D is an assessment question based on information you have learned during your visit You might answer ldquonot enough informationrdquo if the unit is new and they donrsquot have at least three months of data or if the unit is only used as overflow and they are inconsistent with temperature monitoring Mark ldquoNordquo if you have reason to believe the storage unit is not maintaining temperatures properly
Helpful information bull All sites must document temperatures twice a day every day the site is open even if they have a data logger or continuous monitoring system
bull Sites can document the information electronically with some continuous monitoring systems as long as it can show what the current temp is the date time and initials of the person checking ndash this needs to be someone at the site ndash not checking remotely or centrally for a large site or system The site must be able to produce these records during their site visit Reviewing these files can be a challenge due to large volumes and lots of paper
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Temperature Logs on Managing Vaccine (wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml)
IPI Advisor Manual | February 2017 Page 39
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 484 Storage amp Handling Per Unit Temperature Excursions
Question 48 In the event that a temperature excursion(s) occurred in this unit within the last three months requestand review documentation of actions taken to determine whether the provider has a process for properlyaddressing excursions Answer the questions below
A Were vaccines in this unit exposed to out-of-range temperatures in the lastthree months (including today)
Yes No (If no skip to question 49)
B Did the provider quarantine and label vaccines as ldquoDo not userdquo Yes No [X]
C Did the provider place vaccine in a unit where it can be stored under properconditions if applicable
Yes No [X]
D Did the provider contact the Immunization Program to report theexcursion
Yes No [X]
E Was the manufacturer contacted for documentation supporting theusability of the vaccine
Yes No [X]
Review CDC Requirement
The provider must document all excursions and actions taken including the following (1) Quarantine and label vaccines as ldquoDO NOTUSErdquo (2) Place vaccines in a unit where they can be stored under proper conditions (3) Contact the Immunization Program to report an excursion and (4) Contact the vaccine manufacturer to obtain documentation supporting the usability of the vaccine
Goal of this question Address any out-of-range temperatures (temperature excursions) identified in reviewing the last three months of temperature logs or during the site visit If there were any out-of-range temperatures did the site respond appropriately to the situation This is a great opportunity to discuss what to do in the event of an excursion The Clinicians Storage and Handling Mishap Checklist is in the IPI Site Visit information folder and is a good review of the process
Helpful information bull Sites need to know that an excursion does not automatically mean that exposed vaccines are non-viable or unusable Exposed vaccines must be quarantined (marked ldquoDo Not Userdquo) and stored under proper conditions until they have received information from vaccine manufacturers regarding the viability of the vaccine
bull Sites must inform MDH when an excursion occurs
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Clinicians Storage and Handling Mishap Checklist (wwwhealthstatemnusdivsidepcimmunize ipivaxchklstpdf)
Page 40 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 49
Goal of this question Ensure proper placement of vaccines in the storage unit
Note These are all recommendations (best practices) not requirements
Helpful information bull Store vaccine in the middle of the compartment two to three inches away from the coils walls floor and cold air vent The temperature near the floor and walls of the unit differs from that in the middle of the compartment and the cold air vent can freeze refrigerated vaccines
4 Storage amp Handling Per Unit Vaccine Placement
Question 49 Look inside the unit to answer the questions below
A Are vaccines placed in the middle of the unit with space between vaccinesand the sideback of the unit to allow cold air to circulate
Yes No [O]
B Are vaccines stored in their original packages Yes No [O]
C Are there water bottles (for refrigerators) or frozen water bottles (forfreezers) in the unit
Yes No [O]
D Are vaccines store in the doors vegetable bins under or near cooling ventsor on the floor of the unit
Yes [O] No
E Is food being stored in the unit Yes [O] No
Review CDC Recommendation
Vaccines should be stored in their original manufacturer (or CDC centralized distributor) packaging They should be placed in the middle of the unit with space between the vaccines and the sideback of the unit to allow cold air to circulate Vaccines SHOULD NOT be stored in the doors vegetable bins or floor of the unit or under or near cooling vents and there should not be any food inthe unit Water bottles (for refrigerators) or frozen water bottles (for freezers) should be placed throughout each storage unit inorder to (1) stabilize or extend temperatures during a power outage and (2) to serve as physical blocks preventing the placementof vaccines in areas of the unit that are at higher risk for temperature excursions (such as in doors vegetable bins floor ornearunder cooling vents)
bull Vaccines should be kept in their original packaging to Protect them from light Help prevent medication errors by making labels easier to read Provide a moisture barrier that serves as insulation in case of an out-of-range temperature power outage door left open or mechanical failure Simplify managing vaccine inventory
bull Store water bottles in the doors on the floor and near the cold air vent in the refrigerator and frozen water bottles in the freezer to help maintain a stable temperature if there is a power failure and when the door is opened frequently Too many water bottles in the door can prevent the door from closing tightly Mark water bottles ldquoDo Not Drinkrdquo
bull Do not store vaccine in the door or drawers of the refrigerator or freezer Vegetable bins and crisper drawers should be removed from refrigerators or used to store other medical supplies or water bottles
bull If vaccine is stored in a household combination refrigeratorfreezer The top shelf should not be used for storing vaccine because the cold air vent blowing from the freezer will freeze vaccine located there If you must use the top shelf of this type of unit place water bottles underneath the cold air vent to prevent vaccine from being stored there It is recommended that only the refrigerator be used for vaccine storage and a separate stand-alone freezer be used to store frozen vaccine
bull Must not store food or beverages in the refrigerator or freezer because frequent opening of doors can lead to temperature variations that may affect vaccine viability There is also a risk of contaminating vaccines
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Guide (wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml) bull Vaccine Storage Tip Sheet on IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml)
IPI Advisor Manual | February 2017 Page 41
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 4104 Storage amp Handling Per Unit Disconnection from Power Source
Question 410 Ask the provider to demonstrate what measures are taken to ensure that vaccine storage units are notaccidentally physically disconnected from the power supply Which of the following describes the measure(s) taken on this unit
Note to Reviewer bull Large hospitals and healthcare systems may not have the ability to demonstrate labels on plugs or circuitbreakers In such cases verify that the practice has a comprehensive policy and standard operatingprocedures in place to prevent the vaccine storage unit from being physically disconnected from thepower supply
bull While back-up generators may ensure power to the overall facility this question ONLY addresses thevaccine storage unit being accidentally disconnected from the power source either through the plug orthe circuit breaker
Answers A ldquoDo not disconnectrdquo labels on the plug (Choose all that B ldquoWarningrdquo label on the circuit breaker box
apply) C Hard-wired (ie built-in) and has a ldquoDo not disconnectrdquo label on thecircuit breaker box D Hospital or large health care system with a comprehensive written policyand standard operating procedures detailing measures taken to preventvaccine storage units from being accidentally disconnected from the powersupply E No acceptable measures for preventing accidental disconnection frompower supply [X]
[X] The response is non-compliant if only A only B or E is selected
Review CDC Requirement
VFC providers must take steps to protect the power source for all vaccine storage equipment by means of having clear warninglabels on both the plug and the circuit breaker associated with all vaccine storage units Large hospitals and healthcare systems canmeet this requirement by demonstrating that they have comprehensive policies and standard operating procedures to preventvaccine storage units from being physically disconnected from the power supply
Goal of this question Decrease the chance that a vaccine storage unit will be accidently unplugged or power will be turned off while vaccine is in the unit This question addresses only what measures the site has taken to ensure the storage unit is not physically disconnected from its power source
If the site uses labels on the plugs and circuit breakers perform a visual inspection to assess whether the way the stickers are positioned make it clear and obvious to anyone that these units are not to be disconnected
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Do Not Unplug and Warning stickers are included in the folder or available to order on the For
Professionals Order Form (wwwhealthstatemnusdivsidepcimmunizeordermathtml)
Note Once you have completed the 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet for each unit return to the questionnaire to complete sections 5 and 6
Page 42 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
- -
Section 5 Storage amp Handling Site-Wide Question 51
5 Storage amp Handling Site Wide Discussion of Cost amp Quantity of Vaccine
Question 51 Have a discussion with the provider about the cost and quantity of VFC vaccines they are responsible for annually Address the points listed in the note to reviewer below
Note to Reviewer bull Vaccine Shipped (Required) Share the cost of VFC vaccines shipped to the provider in the last calendaryear to make sure the provider understands the contribution made by the VFC Program to their practiceFor new providers who do not have ldquocalendar yearrdquo data share either the actual cost of their currentinventory or use the cost of 10 VFC doses of each of the ACIP-recommended vaccines (approximately $7000) to help estimate their annual cost
bull Storage amp Handling (Required) Make sure the provider understands the cost of vaccines for which they are responsible when they make decisions about purchasing recommended vaccine storage and temperature monitoring equipment
Answer I have discussed with the provider the cost and quantity of vaccines ordered in the previous calendar year
Goal of this question Inform sites of the quantity and value of vaccines that they receive as part of the MnVFC program Providers often donrsquot realize the value of the vaccine in their unit This information is included on your clinic list and on the one page site-specific information
Helpful information bull This discussion must occur and the box on the questionnaire must be checked bull If there isnrsquot actual vaccine value information available tell the site that one vaccine order that includes a box of each of the ACIP recommended vaccines costs approximately $7000
bull MDH may not have specific information for individual sites if they receive vaccine from a central warehouse or pharmacy For those sites MDH will give you numbers for the whole system so you can discuss system wide data as appropriate If individual site information is also included it is usually just varicella-containing vaccines that must be shipped directly to the site
Question 52
5 Storage amp Handling Site Wide Dorm Style Units
Question 52 Determine whether the provider has any dorm-style units on site and answer the questions below
Note to Reviewer A dormitory-style refrigerator is a unit that has both refrigerator and freezer compartments behind a singleexterior door Dorm-style units also have an evaporator plate (cooling coil) which is usually located insidean icemaker compartment (freezer) within the refrigerator
A Does the provider have any dorm-style units that are used at any time tostore vaccines
Yes [X] No (Skip to question 53)
B Does the provider have sufficient space in existing compliant vaccinestorage units to store all vaccines without use of the dorm-style unit at any time
Yes No [X]
Review CDC Requirement
Dorm- and bar-style units are prohibited for vaccine storage Vaccines stored in dorm-style units are considered non-viable and must be returned to the centralized distributor CDC recommends the following vaccine storage unit types (in order of preference)pharmaceutical grade stand-alone or combination units (preferred) householdcommercial stand-alone unitshouseholdcommercial combination units using the refrigerator section only
Goal of this question Ensure no vaccine is stored in dorm-style units even for short periods of time Encourage them to label any units ldquoNo Vaccine Storage Allowedrdquo Vaccine stored in these units is considered non-viable If a site is using a dorm-style unit call the MnVFC program (651-201-5522)
Resource Section 8 in the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 43
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 535 Storage amp Handling Site Wide Storage Unit Space Availability
Question 53 Does the provider have sufficient room across storage units to store current stock as well as anyadditional stock acquired during peak season without overcrowding
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have sufficient storage space to accommodate vaccine stock at the busiest time of year without overcrowding
Goal of this question Ensure that sites have sufficient space in their units to maintain vaccines at the busiest time of year Overcrowding of vaccine limits air circulation and affects the unitrsquos ability to maintain stable temperatures
Helpful information bull Look for signs of overcrowding such as vaccines that are pushed up against the wall bins that are overflowing or storage units that are full during non-peak seasons
Discuss immediate actions if the unit is overcrowded Move some of their vaccines order less vaccine more frequently (once per month preferably) andor purchase another storage unit for overflow
Resource bull Section 8 MnVFC Policy and Procedure Manual
Page 44 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 545 Storage amp Handling Site Wide Expired Vaccines
Question 54 Look in each unit Are there expired vaccines in any of the vaccine storage units at this site
Answers (Choose one)
Yes [X] No
Review CDC Requirement
Vaccines should be rotated weekly and when a new shipment comes in so that longer-dated vaccines are stored behind shorter-dated vaccines If vaccines expire they can no longer be stored in the same storage unit with viable vaccines They must be placedin a container or bag clearly labeled ldquoDo not userdquo and separated from viable vaccines to prevent inadvertent use Expired vaccinemust be returned to the centralized distributor within six months of expiration
Goal of this question Ensure there is no expired vaccine in any storage unit
Helpful information bull Sites can prevent their stock from expiring by rotating vaccines every week andor when a new shipment arrives Longer-dated vaccines are stored towards the back of the unit and shorter-dated vaccines are up front
bull Pay attention to vaccines that expire within the next three months Consider transferring vaccine that will expire soon to another MnVFC-enrolled site that will use the vaccine preferably a site close by It is the transferring sitersquos responsibility to arrange the transfer of the vaccine Be sure to complete the MDH Vaccine Transfer Record form and send it to MDH If they are having difficulty finding a location to accept vaccine contact MDH
bull This is a great opportunity to educate sites about the MDH Nonviable Vaccine Form and the process for returning vaccine The VFC program does get some credit for taxes and fees on vaccine that is returned to the distribution center
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MDH Nonviable Vaccine Form and MDH Vaccine Transfer Record on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfcformshtml)
IPI Advisor Manual | February 2017 Page 45
The 2017 MnVFC Site Visit Paperwork Chapter 4
- -
-
Question 555 Storage amp Handling Site Wide Back up Thermometer
Question 55 Does the provider have a readily available back-up thermometer with a current and valid certificate ofcalibration testing
Note to Reviewer ldquoReadily availablerdquo means that the thermometer is available to perform twice-a-day monitoring for a unit asrequired CDC recommends that the back-up thermometer be maintained on site
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have a readily available back-up thermometer with a current and valid certificate of calibration testing Toprevent the certificates of calibration testing of the primary and back-up thermometers from expiring at the same time the date of calibration testing (or issue date) of the back-up thermometer should be different from the date of calibration testing (or issue date) of the primary thermometer As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meetsVFC program requirements
Goal of this question Ensure sites have one calibrated back-up thermometer onsite that is readily available in the event that the temperature monitoring device in unit fails transportation of vaccine is needed or there are other unexpected circumstances
Helpful information bull As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meets VFC Program requirements
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 56 5 Storage amp Handling Site Wide Preparation of Vaccine
Question 56 When does this provider prepare vaccine for administration to the patient
Note to Reviewer For mass vaccination clinics if one type of vaccine is offered providers may pre-draw up to 10 doses Ifusing pre-filled syringes pre-drawing also means activating the syringe by removing the needle guard orattaching a needle
Answers (Choose all that
apply)
Prepare dose immediately before administration Pre-draw doses for upcoming patients (in a regular clinicpractice) [O] Pre-draw up to 10 doses (in a mass-vaccination clinic) Pre-draw more than 10 doses (in a mass-vaccination clinic) [O] Other [O]
Review CDC Recommendation
CDC recommends preparing vaccines immediately prior to administration in order to assure viability of vaccine and prevent vaccinewastage Vaccines that are not administered immediately are at risk of exposure to temperatures outside of the required rangewhich can affect vaccine viability and ultimately can leave children unprotected against vaccine-preventable diseases
Goal of this question Discuss proper timing and preparation of vaccine(s) for administration These are recommendations not requirements
Helpful information bull Educate staff on the importance of preparing vaccine immediately before administration Pre-drawing of vaccines may lead to concerns related to vaccine viability potency sterility and wastage
Page 46 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 6 Inventory Question 61
6 Inventory Inventory Comparison
Question 61 Visually inspect storage units to determine if existing supply of vaccines proportionately mirrorspopulations served Choose the most accurate statement below
Note to Reviewer bull CDC recommends that providers maintain a four-week supply of inventory bull For this question do not take into account vaccine types that the provider does not order Here simply
make sure that overall the vaccines in the providerrsquos storage units are available in sufficient amounts toserve their patient population
Answers (Choose one)
The current vaccine inventory proportionately reflects the populations identified Only public stock is insufficient [X] Only private stock is insufficient [X] Both public and private stock are insufficient [X] Site uses the replacement method but does not appear to have enough vaccine for their population [X] Other [X]
Review CDC Requirement
VFC providers must order and stock routine vaccines in accordance with their patient population in order to prevent missedvaccination opportunities Having sufficient amounts of all stocks prevents the inadvertent use of VFC vaccines for non-VFC-eligiblepatients and vice versa
Goal of this question Assess whether the site is ordering appropriate quantities of vaccine for the population they serve at their site
Helpful information bull If the site sees 30 percent private-pay patients and 70 percent VFC the stock in their storage units should reflect that proportion If you donrsquot know you can ask the site about their population
bull This is meant to be a general assessment so in a big site if they have only a small amount of vaccine that may indicate an issue with vaccine management
bull CDC recommends smaller more frequent orders (ie monthly) rather than large orders to minimize the amount of vaccine loss if an incident occurs during shipment or in the storage unit Sites should not order more frequently than once a month
bull Sites using the replacement method will only have one stock but it should appear to be large enough for their population
bull Only assess the vaccine types that the site currently stocks in their unit We know there are sites that do not offer all ACIP-recommended vaccines for various reasons That issue will be addressed in question 62
IPI Advisor Manual | February 2017 Page 47
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 626 Inventory ACIP Recommended Vaccines
Question 62 Review providerrsquos current inventory to answer the questions below
A Does the provider offer all routine ACIP-recommendedvaccines for their patient population
Yes (Skip to question C) No [X] Offers all except varicella because direct ship ofvaccine is unavailable from manufacturer
B Which routine vaccines are NOT being offered DTaP Hepatitis A Hepatitis B HIB HPV Influenza Meningococcal
MMR Pneumococcal Polio Rotavirus TdapTd Varicella
C According to Immunization Program Policy does theprovider make accessible all non-routine ACIP-recommended vaccines for those VFC patients whomeet the criteria for receiving them
Yes (Skip to question 63) No [X]
D Which non-routine vaccines are NOT being offered Pneumococcal polysaccharide vaccine (PPSV23) Meningococcal Group B (MenB) Other
Review CDC Requirement
VFC providers agree to comply with immunization schedules dosages and contraindications that are established by the Advisory Committee on Immunization Practices (ACIP) for the vaccines identified and agreed upon in the Provider Agreement UNLESS bull In the VFC providers medical judgment and in accordance with accepted medical practice the VFC provider deems such
compliance to be medically inappropriate for the child bull The particular requirements contradict state law including laws pertaining to religious and other exemptions The VFC program entitles children to the following vaccines DTaP Hepatitis A Hepatitis B HIB HPV Influenza MeningococcalMMR Pneumococcal Polio Rotavirus TdapTd and Varicella VFC providers are also required to ensure that VFC-eligible children have access to non-routine vaccines as needed
Goal of this question Assess if the site is offering all the ACIP-recommended vaccines for the population they serve and these vaccines are in stock on the day of the visit It is important that every MnVFC-eligible child that comes to a providerrsquos office for an immunization is vaccinated
Helpful information bull The Advisory Committee on Immunization Practices (ACIP) is a group of medical and public health experts that develops recommendations on how to use vaccines to control diseases in the United States
bull Specialty providers are not required to offer all routine vaccines but should provide the vaccines appropriate for their population
bull If the site does not offer all routine ACIP-recommended vaccines appropriate for their population check the ldquoNordquo box in Part A then check the appropriate box(es) in Part B for any vaccines not offered Please contact MDH as this situation offers us the opportunity to provide education to the site
bull For non-routine vaccines they must either be in stock or the site must have an alternative protocol in the routine management plan that ensures these children have access when applicable
Resources bull IAC Diseases and Vaccines (wwwimmunizeorgvaccines) bull CDC Advisory Committee on Immunization Practices (ACIP) (wwwcdcgovvaccinesacipindexhtml)
Page 48 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 636 Inventory Separation of Stock
Question 63 Observe how the provider differentiates stock in each storage unit to answer the questions below
A Is it clear which vaccines belong to public stock andwhich belong to private stock
Yes No [X] Not applicable replacement site
B Is it clear which vaccines belong to VFC stock andwhich belong to UUAV stock
Yes No [X] Not applicable replacement site Not applicable not UUAV-enrolled site
Review CDC Requirement
In order to ensure that VFC vaccines are only administered to VFC-eligible children VFC providers that serve both VFC and non-VFCshyeligible children must maintain their vaccine inventories in such a way that they can clearly differentiate public stock from privatestock as well as VFC from other public stock
Goal of this question Assess whether the site can distinguish between MnVFC vaccine and private vaccine If they participate in the Uninsured and Underinsured Adult Vaccine (UUAV) program they should also be able to distinguish between MnVFC stock and UUAV stock Some sites use labels bins boxes etc to differentiate their stock If it is not clear how the site differentiates their stock discuss vaccine management with the staff For follow-up call MDH to discuss doing a follow-up site visit
Sites using the replacement method will not have separate stocksmdashthis is an approved alternative method for keeping track of vaccine
Resource bull Section 10 of the MnVFC Policy and Procedure Manual
IPI Advisor Manual | February 2017 Page 49
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
MnVFC Site Visit Storage and Handling Per Unit Answer Sheet 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet MnVFC PIN ___________________
Question number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
Temperature Monitoring Device Questions Questions 43 47 must be answered separately for the freezer and refrigerator if the unit is a combo Be sure to document responses in the appropriate column
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
All the questions on the Site Visit Storage amp Handling Per Unit Answer Sheet have been discussed previously in section 4 of this manual Use this sheet to record information about all the units at the site visit You will need one sheet for each unit If it is a combination unit (either pharmaceutical or household) you can record both sections on one sheet If they have stand-alone units use one sheet for each unit Do not enter the answers to the questions in section 4 of the questionnaire
If you need more information about any of the questions refer back to the main questionnairemdashthe complete question additional guidance including notes to the reviewer and the CDC requirements are there Also if the site is not meeting the requirement you will go back to the questionnaire to complete the ldquoActions if Non-compliantrdquo section including the root cause analysis and follow-up sections
When you have completed the assessment of all the storage units remember to go back to the questionnaire to complete sections 5 and 6
Page 50 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
ndash
ndash
MnVFC Provider Follow-up PlanThe goal of the Provider Follow-up Plan is to communicate with the site all of the VFC requirements any unmet requirements found during your site visit and the timeline for completing the required action The left hand column is a box to check for ldquoUnmetrdquo requirements
Helpful information bull The form can be used to review what the site is doing well and what they need to work on
bull For requirements that have specific documentation that needs to be sent to you use the notes section
2017 MnVFC Provider Follow-up Plan Site _______________________________________________ MnVFC PIN ____________ Date of Visit ___________
Thank you for participating in this MnVFC compliance site visit Please review this visit summary including follow-up actions and timelines for completion Unmet MnVFC requirements and recommendations have a checked box next to them The goal of this plan is to support you with successfully implementing the program and improving access to vaccines for VFC-eligible children
Unmet Question VFC Requirements Section 1 Changes to Key Staff
Q12 Change in the Medical Director Immunization Manager Vaccine Coordinator or back-upKey Staff must be communicated to the immunization program by emailing healthmnvfcstatemnus Changes Notes
Q12 Key staff must complete the annual training on VFC program requirements and print theAnnual Training certificate of completion Documentation Required Action
Staff that have not completed the MnVFC online training must complete it and send acopy of the certificate to the reviewer Training can be found on the MnVFC website (wwwhealthstatemnusvfc) Due date 1 month
Notes
Unmet Question VFC Requirements Section 2 Eligibility
Q21 Provider staff must possess a working knowledge of all VFC eligibility criteria and use thoseVFC Eligibility criteria to screen children prior to administering VFC vaccines
Categories Notes
bull This form provides documentation needed for follow-up actions when you send your thank you email
The second to last page of the Provider Follow-up Plan has a summary of the MnVFC program recommendations These are to remind the site about best practices they may want to improve upon even though they are not yet requirements of the program For example you could discuss the recommendation about storage units if they currently have a combination household unit and are using both sections
The last section is for your signature and the person you met with In most sites it will be the immunization manager or vaccine coordinator who signs the form unless the medical director attended the site visit You keep the original copy and the site will need to keep a copy for themselves
To be completed by the site visit reviewer
I acknowledge that a VFC site visit was performed on __________________ (visit date) The follow-up plan which includes a list of all current VFC program requirements and recommendations assessed during the visit and any required follow-up actions was provided at the end of the visit
Site visit reviewer
Phone
Reviewer Signature Date
To be completed by the provider
I acknowledge that our practice took part in the VFC site visit noted above I understand the findings of the visit and any required actions that must be taken by our office in order to meet VFC program requirements
Medical Director (or designee) Name Title
Medical Director (or designee) Signature Date
IPI Advisor Manual | February 2017 Page 51
The 2017 MnVFC Site Visit Paperwork Chapter 4
After the Site Visit Send a thank you email highlighting the unmet requirements documents you need from the site to resolve the issue(s) and the date you need them Make sure to include the link to the Site Visit Survey (httpssurveyvovicicomseashxs=56206EE334CE0B14)
Please refer to Chapter 3 for more information about future follow-up required after the visit including forms and documentation
Resource bull Sample Thank You letter on IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml)
Chapter 5
IPI Advisor Resource List MnVFC Program 651-201-5522
MnVFC wwwhealthstatemnusvfc
bull Separate Stock and Replacement Method Policies and Procedures Manuals bull Online trainings bull MnVFC Announcements sign up to receive them via email bull Ordering MDH vaccine bull MnVFC forms Screening forms Reporting forms Others MDH Nonviable Vaccine Form MDH Vaccine Transfer Record and Vaccine Borrowing Report
bull MnVFC promotional materials bull Immunization Billing Guidance for MnVFC and Immunization Billing Guidance for MnVFC Replacement Sites Immunization Practices Improvement Program (IPI) wwwhealthstatemnusdivsidepcimmunizeipi
bull IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml) bull IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml) IPI Resource Folder Contents (wwwhealthstatemnusdivsidepcimmunizeipiipifolderpdf)
Minnesota Immunization Information Connection (MIIC) wwwhealthstatemnusmiic
bull MIIC regions and regional coordinators
Clinical Practice MDH Immunization Program wwwhealthstatemnusimmunize
Got Your Shots News wwwhealthstatemnusdivsidepcnewslettersgys
MDH Immunization Information for Health Care Providers wwwhealthstatemnusdivsidepcimmunizehcp
bull Got Your Shots A Providers Guide to Immunization in Minnesota bull Vaccine protocols bull Forms for tracking patient immunizations bull Immunization schedules for Health Care Providers Immunization Action Coalition (IAC) wwwimmunizeorg
bull Ask the Experts bull VISs (Vaccine Information Statements and translations) bull Administration screening questions bull Medical management of vaccine reactions bull Order form for Californiarsquos Immunization Technique DVD Best Practices with Infants Children and Adults
Page 52 IPI Advisor Manual| February 2017
IPI Advisor Resource List Chapter 5
CDC ldquoPink Bookrdquo wwwcdcgovvaccinespubspinkbookindexhtml
CDC Advisory Committee on Immunization Practices (ACIP) wwwcdcgovvaccinesacip
CDC Vaccines and Immunizations wwwcdcgovvaccines
VAERS reporting httpvaershhsgovindex
Storage and Handling Got Your Shots Providers Guide ndash Managing Vaccine wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml
MnVFC Guide to Temperature Monitoring Devices wwwhealthstatemnusvfc
MDH Clinicianrsquos Vaccine Mishap Checklist wwwhealthstatemnusdivsidepcimmunizeipivaxchklstpdf
MDH Vaccine Storage Guide wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml
CDC Vaccine Storage and Handling Toolkit wwwcdcgovvaccinesrecsstoragetoolkit
You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Vaccine manufacturer phone numbers wwwcdcgovvaccinespubspinkbookdownloadsappendicesFcontact-info-manufactpdf
IAC Checklist for Safe Vaccine Handling and Storage wwwimmunizeorgcatgdp3035pdf
IAC Donrsquot Be Guilty of These Errors in Vaccine Storage and Handling wwwimmunizeorgcatgdp3036pdf
Additional Resources Print materials from MDH ndash order forms wwwhealthstatemnusdivsidepcimmunizeordermathtml
Vaccine Education Center ndash Childrenrsquos Hospital of Philadelphia wwwchopeduservicevaccine-education-centerhomehtml
California Department of Public Health ndash Interactive training on vaccine administration and storage and handling handout on transporting vaccine and how to package wwwezizorg
IPI Advisor Manual | February 2017 Page 53
IPI Advisor Resource List Chapter 5
CDC vaccine price list wwwcdcgovvaccinesprogramsvfcawardeesvaccine-managementprice-listindexhtml
Vaccine Information Statements (VIS) wwwcdcgovvaccineshcpvisindexhtml
CEU Opportunities CDC Immunization Education and Training wwwcdcgovvaccinesedindexhtml
Immunization You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Page 54 IPI Advisor Manual| February 2017
- Introduction
-
- Welcome to the Immunization Practice Improvement (IPI) Program
- Contact Information
-
- Chapter 1
- Requirements to Participate in the MnVFC Program
- Vaccines for Children Program
- Chapter 2
- Reimbursement for MnVFC Visits
- Types of Visits
- Your MnVFC Clinical CoordinatorPlanner
- New IPI Advisor Training Requirements
- Your Role as an IPI Advisor
- Reasons MDH Would Do All or Part of a Visit
- Chapter 3
- Future follow-up
- Conducting the Visit
- Preparing for the Visit
- Information for the Visit
- Site Visit Checklist
- Scheduling the Visit
- Chapter 4
- After the Site Visit
- MnVFC Provider Follow-up Plan
- MnVFC Site Visit Storage and Handling Per Unit Answer Sheet
- Section 6 Inventory
- Section 5 Storage amp Handling Site-Wide
- Section 4 Storage amp Handling Per Unit
- Section 3 Documentation
- Section 2 Eligibility
- Section 1 Provider Details
- The Site Visit Reviewer Legend
- MnVFC Site Visit Questionnaire
- Required Paperwork for Site Visits
- Chapter 5
-
IPI Advisor Manual | February 2017 Page 25
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 32
3 Documentation Vaccine Dose Documentation
Question 32 Review a minimum of 10 patient immunization records from the last six months (or 12 months ifnecessary) to assess compliance with documentation requirements set forth by Statute 42 US Code 300aa-25 (See note to reviewer below)
Note to Reviewer Criteria for Record Selection 1) Record selection must be completely random the Provider must not know prior to the visit which records
will be reviewed 2) Patient must have been 0-19 years of age at the last visit (Note Records of 19-year-old patients may allow
you to see if VFC vaccines are being used beyond the allowable age)
Records are Compliant if they Contain ALL the Below Elements
bull Address of clinic where vaccine was administered bull Publication date of VIS bull Name of vaccine administered bull Name of vaccine manufacturer bull Date vaccine was administered bull Lot number bull Date VIS was given bull Name and title of person who administered the
vaccine
A Number of records reviewed
B Number of records that contain ALL required documentation elements
If fewer than 10 records are reviewed select the reason why Provider does not have 10 patient records with immunizations in last 12 months
[X] Follow-up isrequired if one ormore records do not meet requirements
Goal of this question Assess whether the site is documenting all required information in each patientrsquos medical record for every vaccine dose administered in accordance with the National Childhood Vaccine Injury Act
Resources bull Section 6 of the MnVFC Policies and Procedures Manual bull National Vaccine Injury Compensation Program (wwwhrsagovvaccinecompensation)
Question 33
3 Documentation Record Retention
Question 33 Is the provider able to demonstrate (preferred) or clearly describe how they maintain historical VFCeligibility documentation for three years
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers are required to maintain all records related to the VFC program for a minimum of three years (or longer if requiredby state law) and upon request make these records available for review VFC records include but are not limited to VFC screening and eligibility documentation billing records medical records that verify receipt of vaccine vaccine ordering records and vaccinepurchase and accountability records
Goal of this question Make sure the site understands they are required to keep all MnVFC screening documentation for at least three years either electronically or on paper This information should be available to you at the time of the visit and future visits
Resource bull Section 7 of the MnVFC Policies and Procedures Manual
Page 26 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 34
3 Documentation Borrowing Documentation
Question 34 Discuss borrowing practices with the provider to answer the questions below
Note to Reviewer bull To be considered ldquofully documentedrdquo documentation for each borrowed dose must include thefollowing information
Vaccine type borrowed Date the dose was administered Stock used (VFC or private) Reason appropriate vaccine stock was not used Patient name and date of birth Date dose was returned to appropriate stock
A Did the provider state that they had borrowed any vaccines (whetherdocumented or not) since the last VFC Compliance Site Visit
Yes No (If no skip to question 36)
B Are there any doses for which there is no documentation (ie provider hasindicated that doses were borrowed but cannot verify how many or why)
All doses are documented Some doses are not documented [X] No doses are documented [X] (if nodoses documented skip toquestion 36)
C Were all borrowed doses fully documented (See Note to Reviewer above) Yes No [X]
D Were all borrowed VFC doses either replaced or an order submitted to replacethe doses Yes No [X]
Review CDC Requirement
VFC providers are expected to maintain an adequate inventory of vaccine for VFC and non-VFC-eligible patients It is theresponsibility of the VFC provider to appropriately schedule and place vaccine orders VFC providers must also rotate stock to ensure timely use of short-dated vaccines Borrowing of vaccine between private and public inventories must be a rare unplanned occurrence and cannot serve as a replacement system for a VFC providerrsquos privately purchased vaccine inventory All instances ofborrowing must be properly documented reported and replaced
Goal of this question Assess vaccine accountability by verifying that children are receiving vaccine from the appropriate stock
Borrowing is when a fully insured child receives a dose of MnVFC vaccine or a MnVFC-eligible child receives a dose of private vaccine This should be a rare unplanned occurrence The site must document any borrowing of vaccine between stocks ideally on the VFC Borrowing Report Form If they are not currently using the form review it with them and encourage them to post it close to their vaccines It does not need to be sent to MDH but should be kept for 3 years and filed with their MnVFC documents to be reviewed whenever they have a regular or unscheduled (unannounced) site visit
Helpful information bull Understand and report on staffrsquos verbal (ie anecdotal) accounts of borrowing obtained during the visit Often sites do not know that what they do is considered borrowing or they think borrowing is acceptable and documentation isnrsquot needed so long as those vaccines are eventually replaced
bull Since sites using the replacement method only have one stock of vaccine they very rarely borrow bull This question asks for future follow-up in 6 months Make a note on your calendar and ask them to send you a copy of their borrowing reports for the previous 6 months with documentation of doses borrowed and replaced We will remind you if we donrsquot hear from you at the 6 month time frame Complete the Follow-up Form and attach the borrowing form
Resources bull Vaccine Borrowing Report on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfc formshtml)
bull Section 10 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 27
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 353 Documentation Borrowing Reasons
Question 35 Based on your discussion with the provider and a review of borrowing reports document the dosesborrowed for each reason and answer the questions below
Note to Reviewer bull Short-dated vaccines are doses that are likely to expire before they can be used bull Exchanging short-dated vaccines should only occur in practices that have a small number of private
patients
A Reasons for Borrowing a VFC Dose (Enter the number of _____ Private vaccine shipment delay (order placed on time but delay in shippingreceipt)
vaccine doses borrowed for each
reason in the spaces
_____ Private vaccine not useable on arrival (vials broken temperature monitor out of range) _____ Ran out of private vaccine between orders (provider orders not placed on time) [X]
provided) _____ Short-dated private dose was exchanged with VFC stock _____ Accidental use of VFC dose for a private patient (human error) _____ Replacement of private dose with VFC when insurance plan did not cover vaccine _____ OtherDocumented dose did not include reason for borrowing [X]
(Explanation Required) Reasons for Borrowing a Private Dose _____ VFC vaccine shipment delay (order placed on time but delay in shippingreceipt) _____ VFC vaccine not useable on arrival (vials broken temperature monitor out of range) _____ Ran out of VFC stock between orders (provider orders not placed on time) [X] _____ Short-dated VFC vaccine dose was exchanged with private dose _____ Accidental use of a private dose for a VFC-eligible patient (human error) _____ OtherDocumented dose did not include reason for borrowing [X]
(Explanation Required)
B Enter date range for instances of borrowing reviewed in the borrowing report Note If ldquoDate of earliest instancerdquo is not available use the date of the last VFC Compliance Visit If ldquoDate of last instancerdquo is not available use the date of thecurrent VFC Compliance Visit
Date of earliest instance
Date of last instance
C Does borrowing appear to be a routine practice Note To determine whether borrowing is a routine practice assess frequency of and repeating reasons for borrowing Examples Frequent accidental use of incorrect stock exchanging short-dated vaccines or issues with ordering and shipment
Yes [X] No
Goal of this question Determine the reasons why the site is borrowing vaccine
If sites are using the Vaccine Borrowing Report review the reasons for borrowing to help document borrowed VFC andor private doses If they have not been documenting borrowing on this report (or any other form) estimate their borrowing practices If you do not know the date range for their borrowing use the last site visit date to the current visit date The use of ldquootherrdquo as the reported reason for borrowing should be rare if ever and would require explanation and follow up
Helpful information bull Look to see if they routinely maintain insufficient amounts or types of vaccine to support their public and private patients that leads to borrowing
bull Pay attention to borrowing cases documented as ldquoaccidentalrdquo Repetitive accidental borrowing may indicate an issue with ordering processes or insufficient staff training
bull Borrowing is not a place to document wasted or lost doses bull The time period of the borrowing may give you clues about the root cause Were the borrowed doses concentrated in a short period or spread out across several months or a year Are all vaccine types being borrowed or just one
bull If borrowing seems to be an issue discuss vaccine management ordering procedures
Resources bull Vaccine Borrowing Report on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfc formshtml)
bull Section 10 in the MnVFC Policies and Procedures Manual
Page 28 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 36
3 Documentation Vaccine Management Plan
Question 36 Physically review the providerrsquos Vaccine Management Plan to answer the question below
A Does the provider have a Vaccine Management Plan Yes No [X] (If no skip to question 37)
B Does the plan list the current Immunization Manager Vaccine Coordinator andback-up
Yes No [X]
C Does the plan address proper vaccine storage and handling practices Yes No [X]
D Does the plan specify vaccine receiving procedures Yes No [X]
E Does the plan contain procedures for what to do with vaccine in the event of an emergency
Yes No [X]
F Does the plan contain procedures for vaccine ordering Yes No [X]
G Does the plan address inventory control (example stock rotation) Yes No [X]
H Does the plan address how to handle vaccine wastage Yes No [X]
I Does the plan address staff training and documentation on vaccine managementstorage amp handling
Yes No [X]
J Does the plan contain a review date that falls within the last 12 months Yes No [X]
K Has the plan been signed by the individual responsible for its content Yes No [X]
Review CDC Requirement
VFC providers must develop maintain and implement a Vaccine Management Plan for routine and emergency vaccinemanagement The plan must contain the current Vaccine Coordinator and back-up proper storage and handling practicesshipping and receiving procedures emergency procedures procedures for vaccine ordering inventory control (eg stock rotation)how to handle vaccine wastage and staff trainingdocumentation on vaccine management storage and handling The plan must bereviewedupdated annually or more frequently if changes occur A ldquoreview daterdquo and signature are required on all plans in order tovalidate that they are current
Goal of this question Evaluate the sitersquos plan for vaccine management It is especially important that they have a plan for emergency management of their vaccine in the case of equipment failure or power outage Encourage all sites to read and sign the MnVFC Policies and Procedures Manual and complete the emergency plan or be able to show you a plan of their own
If the provider is not able to physically show you the plan at the time of the visit or if the recorded review date is not within the last 12 months you must mark that this requirement is unmet The Vaccine Management Plan is important in times of emergency and it should be easy to access by any staff member at any time Encourage them to post the plan and put a copy with the packing supplies
Helpful information bull Encourage the site to fill in the ldquoImmunization Managerrdquo and ldquoVaccine Coordinatorrdquo fields in the
MnVFC Policies and Procedures Manual for their own referencebull The emergency plan in the manual can be reviewed from last year and included in this yearrsquos manual (with an updated signature and date) if there have not been any changes
bull If information in the plan is outdated site staff will not be well equipped to safely manage vaccines in the event of a power-outage or other emergency situation
bull If their institutional policy is only reviewed and updated every 3-4 years (as many are) the staff may need to sign the MnVFC Polices and Procedure Manual to meet this requirement
Resource Routine Vaccine Management Plan and Emergency Vaccine Management Plan in the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 29
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 37
3 Documentation VIS amp VAERS
Question 37 Review the providerrsquos Vaccine Information Statements (VISs) and discuss providerrsquos VAERS process toanswer the questions below
A Does the provider have readily available up-to-date VISs for all ACIP-recommendedvaccines relevant to the populations it serves
Yes No [X]
B Does the provider make a VIS available for patientsparents before eachvaccination
Yes No [X]
C Does the provider know how and when to report clinically significant adverseevents using VAERS
Yes No [X]
Review CDC Requirement
VFC providers are required to distribute the current Vaccine Information Statements (VIS) each time a vaccine is administered and maintain records in accordance with the National Childhood Vaccine Injury Act (NCVIA) which includes reporting clinicallysignificant adverse events to the Vaccine Adverse Event Reporting System (VAERS) For a list of current VISs visit CDCrsquos Vaccine Information Statements (httpwwwcdcgovvaccineshcpvis) website
Gal of this question Ensure the site has the most current VISs and is giving them to each patientparent before administering the vaccine in compliance with the federal law Parents must be educated about the vaccine their child will receive and be aware of possible contraindications and side-effects in order to make well-informed decisions about their childrsquos health
Helpful information bull Ask to see the sitersquos VISs to determine if they have an active protocol for giving VISs to parents Review to make sure they are current Ask if they know where and how to report vaccine adverse events
Resources bull Section 3 in the MnVFC Policies and Procedures Manual bull CDC Vaccine Information Statements (wwwcdcgovvaccineshcpvisindexhtml) Site may sign up for email updates for the current list of VIS publication dates for the most up-to-date version
bull IAC Itrsquos Federal Law You must give your patients current Vaccine Information Statements (wwwimmunizeorgcatgdp2027pdf)
bull VAERS (httpsvaershhsgovindex)
Question 38
3 Documentation Anaphylaxis protocol
Question 38 Does the site have an anaphylaxis protocol which is clearly posted near the emergency kit
Answers (Choose one)
Yes No [X]
Review CDC Requirement
An anaphylaxis protocol must be clearly posted in the area where vaccines are administered
Goal of this question Make sure site is prepared for a severe allergic or anaphylactic reaction to a vaccine
Resources bull Section 11 in the MnVFC Policies and Procedures Manual bull IAC protocols Child and Teens (wwwimmunizeorgcatgdp3082apdf) and Adults (wwwimmunize orgcatgdp3082pdf)
Page 30 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
i
i i i - li i i i i i l
Section 4 Storage amp Handling Per Unit The goal of this section is to assess vaccine storage
2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet practices in each unit at the site MnVFC PIN ___________________
The 2017 MnVFC Storage amp Handling Per Unit Answer Sheet is a worksheet to document the answers to the questions in this section for each unit (combination or stand-alone) Fill in the answers to the questions in Section 4 on the answer sheet not in the questionnaire
The answer sheet has an abbreviated form of each question If you need further information on that question refer back to the full questionnaire Also if you find an area where the site is not meeting the requirements you will need to go back to that question on the 2017 MnVFC Site Visit Questionnaire to complete ldquoActions if Non- compliantrdquo section including the root cause analysis and follow-up sections If there is a problem in more than one unit make a note on the questionnaire which unit you are referring to in the Notes section
Important You must fully assess any unit that may be used to store VFC vaccines even if there are no VFC vaccines there on the day of the visit If there are no vaccines and the site is not documenting twice a day temperatures discuss the need to ensure the unit is maintaining stable temperatures by monitoring for one week before placing vaccines in the unit
Quest on number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
for the freezer and e co umn
Temperature Monitoring Dev refr gerator f the un
ce Quest ons Quest ons 4 3 4 7 must be answered separate y t s a combo Be sure to document responses n the appropr at
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
44D Data downloaded and reviewed routinely (eg weekly)
Yes No [O]
Yes No [O]
45A Certificate of Calibration Testing Yes No [X]
Yes No [X]
45B Date of calibration
45C Date certificate expires [X] Follow-up is required if expired [X] Follow-up is required if expired
45D Certificate contains all necessary items
Yes No [X]
Yes No [X]
46 Probe properly placed Yes No [X]
Yes No [X]
47A Two temperature readings per day
Yes No [X]
Yes No [X]
47B Time date and name (or initials) for each reading
Yes No [X]
Yes No [X]
47C Current temperature and minmax temperatures (if
Current ________deg Minimum ________deg Maximum _deg
Current ________deg Minimum ________deg Maximum _deg
Sections 5 and 6 contain questions about storage and handling site wide and inventory It is helpful to keep those questions in mind as you assess the individual storage units Think about dorm-style units expired vaccine vaccine supply room for vaccine stocking all the recommended vaccines and separation of stock if appropriate
NOTE The sections that follow require reviewers to validate responses by looking at vaccine storage units temperaturemonitoring equipment and the vaccine inventory inside a unit bull For section 4 use a separate Storage amp Handling Per Unit Answer Sheet for each unit to document the findings (combination
units using both sections can be documented on the same answer sheet) bull When an unmet requirement is identified return to this questionnaire to complete the ldquoActions if Non-compliantrdquo section for
that question bull After you complete one answer sheet for each unit return to the questionnaire to complete sections 5 and 6 using information
you gathered while assessing the units The questions in sections 5 and 6 (Storage amp Handling Site-Wide and Inventory) are notunit-specific but do require that the response be based on a thorough assessment of all the providersrsquo units
4 Storage amp Handling Per Unit
Description On the Storage amp Handling Per Unit Answer Sheet place a name that will allow you or someone else from your program to easily identify this unit in the event of follow-up We recommend using Brand + Location(example Samsung - Room 123) Save each Storage amp Handling Per Unit Answer Sheet with the Brand + Location in the file name
(example SamsungRoom123doc)
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The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 41
4 Storage amp Handling Per Unit Storage Unit Build amp Use
Question 41 Below select the build and use of the vaccine storage unit you are assessing
Note to Reviewer Dorm-style units Do not add dorm-style units here Dorm-style units will be addressed in section 5 Units storing only private stock You must review these storage units even if they contain only private stockat the time of the visit because that vaccine could be administered to VFC patients
A What type of unit is this A Stand-alone B Combination
B Select use if stand-alone A Freezer B Refrigerator
Select use if combination A Use both sections to store vaccine B Use freezer section only to store vaccine C Use refrigerator section only to store vaccine
Goal of this question Identify the unit you are evaluating The description asks you to create a unique name for this unit so that you will be able to identify the same unit in future site visits Put this description on the top of the answer sheet (ie make and location)
Helpful information bull A stand-alone unit is either a refrigerator or a freezer It does not have both sections in the unit bull If there is a combination unit note if the site uses both the refrigerator and freezer or only one section of the unit to store vaccines CDC does not recommend the use of either section or the freezer section only of combination household units
bull If your site utilizes the separate stock method of vaccine management you must review storage units even if they contain only private stock at the time of the visit because there is a chance that those vaccines could be administered (borrowed) to VFC-eligible patients
Page 32 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 424 Storage amp Handling Per Unit CDC Recommended Storage Units
Question 42 Below document the grade of the vaccine storage unit you are assessing
Note to Reviewer Pharmaceutical Also called ldquopurpose-builtrdquo these units are designed by the manufacturer specifically tostore vaccines or other biological materials Commercial Although usually intended to store food and beverages commercial units are often larger and more powerful than the household units found in most homes Though these units are intended to meet thehigher demands of larger facilities these units are not specifically built for the storage of biologicalmaterials Household (non-commercialdomestic) These units are usually smaller than commercial units and areintended for use in small offices and in homes ndash typically for food storage However just like commercialunits they are not designed specifically for the storage of biological materials Such units are usually available in common home supply stores
Answers (Choose one)
Select grade A Pharmaceutical B CommercialHousehold
[O] CDC does not recommend the use of both sections or the freezer section only of combination commercialhousehold units
Review CDC Recommendation
CDC recommends the following vaccine storage unit types (in order of preference) pharmaceutical grade stand-alone orcombination units (preferred) householdcommercial stand-alone units householdcommercial combination units using therefrigerator section only
Goal of this question Assess the grade and type of each storage unit bull Pharmaceutical grade units may be stand-alone or combination units that are often metal may have glass in the door for viewing inside often have an external digital temperature display and are manufactured by medical companies
bull Commercial or household units often look like your kitchen appliance have vegetablemeat drawers in the unit and are manufactured by household appliance companies
bull Occasionally you might find a medical grade unit which is usually a commercialhousehold unit with a lock and 3-prong plug These are still considered household units because of their ability to maintain proper temperatures and air flow Studies show that household stand-alone units are better able to maintain consistent temperatures than their combination counterparts Combination household units used to store vaccine in both sections of the unit is no longer recommended and may be prohibited in the future Combination household storage units that are having difficulty maintaining a cold enough freezer temperature and a warm enough refrigerator temperature should be replaced or a separate stand-alone freezer should be purchased
For frozen vaccines the most cost effective solution is for the site to purchase a small stand-alone freezer The site may need time to budget for a stand-alone storage unit
Resources bull Replacing Combination Household Units Tip Sheet on IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml)
IPI Advisor Manual | February 2017 Page 33
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 434 Storage amp Handling Per Unit Temperature Monitoring Device in the Unit
Question 43 Determine whether there is a temperature monitoring device in this section of the storage unit andanswer the questions
A Is there a temperature monitoring device in this section of thestorage unit
Yes No [X] (If no skip to question 47)
B Who is responsible for supplying the temperature monitoring device in this section of the storage unit Provider
Review CDC Requirement
Certificates of calibration testing provide confidence that the temperature monitoring device is measuring temperaturesaccurately All units storing VFC vaccines must have a calibrated temperature monitoring device with a current and valid certificateof calibration testing All certificates must contain modeldevice name or number serial number date of calibration testing (report or issue date) and Instrument Passed testingInstrument in Tolerance (Recommended uncertainty = +-05ordm C (+-1ordm F))
Goal of this question Assess whether there is a temperature monitoring device in the unit If the unit is not being monitored at all call MDH at 651-201-5522 for guidance
Helpful information bull This question does not ask whether the temperature monitoring device is working or the characteristics of the device These issues will be addressed later in the questionnaire
bull For part B the provider is always responsible for supplying the temperature monitoring device Even if their thermometer or data logger was originally from MDH it is their responsibility to ensure it is functional and calibrated
Resources bull Section 8 in the MnVFC Policies and Procedures Manual
Page 34 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 444 Storage amp Handling Per Unit CDC Recommended Temperature Monitoring Device
Question 44 Assess the temperature monitoring device in this section of the storage unit to answer the questionsbelow
A Is the temperature monitoring device a continuous monitoring and recordingdevice (eg data logger)
Yes No [O] (Skip D)
B Does the temperature monitoring device have a probe in buffered material Yes No [O]
C Does the temperature monitoring device have a digital display that can beeasily read from the outside of this unit
Yes No [O]
D Is data downloaded and reviewed routinely Yes No [O]
Review CDC Recommendation
As of Jan 1 2018 all VFC providers must use continuous temperature monitoring devices (eg data loggers) to monitor vaccinesthat will be administered to VFC-eligible children Routine review and accessibility of temperature data is critical for determining whether vaccine has been properly stored and for assessing usability of vaccine that was involved in a temperature excursion Tomeet VFC Program requirements the device must also be equipped with bull A temperature probe bull An active temperature display that can be easily read from the outside of the unit bull The capacity for continuous monitoring and recording capabilities where the data can be routinely downloaded
The following are additional recommended features for these devices bull Alarm for out-of-range temperatures bull Current minimum and maximum temperatures display bull Low battery indicator bull Accuracy of +- 1degF (05degC) bull Memory storage of at least 4000 readings bull User programmable logging interval (or reading rate) recommended at a maximum time interval of every 30 minutes bull Use of a probe that best reflects the temperature of the vaccine (such as a buffered probe)
Goal of this question Assess the temperature monitoring device in the storage unit Note that these are all recommendations not requirements at this time
This is a great teaching opportunity for sites who do not currently have a continuous temperature monitoring device Beginning Jan 1 2018 all units that store MnVFC vaccine will be required to have a continuous temperature monitoring device (ie a data logger or a continuous temperature monitoring system) Unlike a minmax thermometer a continuous temperature monitoring device provides detailed information on all temperatures recorded at pre-set intervals For excursions it can provide information on when a temperature went out-of-range for how long and what the temperatures were This is essential information that vaccine manufacturers need to know to assess the viability of the vaccine following an excursion
Helpful information bull Sites are required to monitor and record temperatures twice daily however temperature excursions can easily occur in the 12 hours or longer between readings Continuous temperature monitoring can help manufacturers determine vaccine viability
bull Continue to encourage sites to document and evaluate minimum and maximum temperatures the storage unit reached since the last reading and respond appropriately to out-of-range temperatures
IPI Advisor Manual | February 2017 Page 35
The 2017 MnVFC Site Visit Paperwork Chapter 4
bull It is recommended that sites download and review data weekly Discuss with sites that reviewing temperature monitoring device data also includes responding appropriately if they identify out-of-range temps
bull There is sometimes confusion about the difference between a data logger and a continuous temperature monitoring system Here are some differences
Data Loggers Continuous Monitoring Systems Have an external display similar to thermometers May or may not have an external display Have a detachable probe Probe is usually attached to transmitter Need to be plugged into the computer or cradle to download information on a regular schedule
Wirelessly sends data to computer system
Create a file of data that needs to be saved on the computer
Data is stored within the system not a separate file
Doesnrsquot allow documentation of twice a day temperature checks in the file
May allow documentation of twice a day temperature checks within the system
More about the 2018 requirement for a continuous temperature monitoring device
Required Features bull The continuous temperature monitoring device must have Continuous monitoring and recording capabilities to track and record temperatures over time The capacity to routinely download temperature data to a computer (recommended at least weekly) or wirelessly transmit data Detachable probe in a bottle filled with a thermal buffer (eg bio-safe glycol) if the data logger needs to be detached in order to download data Active temperature display
Recommended Features bull MnVFC recommends continuous temperature monitoring devices with Alarm for out-of-range temperatures Accuracy within +-1degF (+- 05degC) Low battery indicator Display of current minimum and maximum temperatures Memory storage of at least 4000 readings User programmable logging intervals (eg the user can set how often the device records the temperature)
Note that these are all currently recommendations not requirements yet
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Page 36 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 45
Goal of this question Ensure the temperature monitoring device is properly calibrated The certificate of calibration testing means that the device has been tested and it is accurately measuring temperatures within established testing limits The certificate of calibration ensures that the device meets all the required components
Helpful information bull The provider is always responsible for having a current certificate of calibration (or copy) on-site
bull To be considered ldquovalidrdquo a certificate of calibration must contain these required elements Modeldevice name or number Serial number
4 Storage amp Handling Per Unit Certificate of Calibration Testing
Review CDC Requirement
Certificates of calibration testing provide confidence that the temperature monitoring device is measuring temperaturesaccurately All units storing VFC vaccines must have a calibrated temperature monitoring device with a current and valid certificateof calibration testing All certificates must contain modeldevice name or number serial number date of calibration testing (report or issue date) and Instrument Passed testingInstrument in Tolerance (Recommended uncertainty = +-05ordm C (+-1ordm F))
Question 45
Note to Reviewer
A
B
C
D
E
Review the certificate of calibration testing for the temperature monitoring device in this section of the storage unit and answer the questions below
bull How to determine certificate of calibration testing expiration date 1) Identify the certificate issuecalibration date 2) Apply the Immunization Program-required frequency for calibration testing Example If the
issuecalibration date is 12312013 and Immunization Program policy requires testing every twoyears the expiration date is 12312015
bull Certificates must include all of the below bull ModelDevice Name or Number bull Serial Number bull Date of Calibration Testing (Report or Issue Date) bull Instrument Passed testing (Instrument in Tolerance)
Is there a certificate of calibration testing for the temperature monitoring Yes device in this section of the storage unit No [X]
What is the date of calibration for the temperature monitoring device in this section of the storage unit
What is the certificatersquos date of expiration based on ImmunizationProgram policy (See note to reviewer to determine expiration date) [X] Follow-up is required if
certificate is expired
Does the certificate contain all the necessary items listed in the Note to Yes Reviewer No [X]
Who is responsible for supplying the current and valid certificate of Provider calibration for this temperature monitoring device
Date of calibration testing (report or issue date) Note If there is no expiration date the certificate expires 2 years from the date of calibration Whether the instrument passed or failed testing (or instrument in tolerancenot in tolerance)
bull Recommended element Documented uncertainty of +- 1degF [05degC]
If these elements are present the certificate is considered valid If the certificate contains information about the recommended element or the entity that issued the certificate that is helpful but not required
To determine if a certificate of calibration testing was issued by an appropriate entity check to see if the certificate indicates one or more of these items (this is the wording used to help sites evaluate if their calibration is accurate but is not required on the certificate itself to be considered valid)
bull Conforms to ISO 17025 bull Performed by an ILACMRA Signatory body accredited laboratory You can review this list of the ILAC MRA and Signatories (httpilacorgilac-mra-and-signatories)
bull Traceable to the standards maintained by NIST bull Meets specifications and testing requirements for the American Society for Testing and Materials (ASTM) Standard E2877 tolerance Class F (le 05 degC) or better
bull Includes reference to another acceptable accuracy validation method such as comparison to other traceable reference standards or tests at thermometric fixed points
Note CDC recommends that certifications be issued for the entire monitoring unit (detachable probe data logger etc) and not individual certificates for each component
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The 2017 MnVFC Site Visit Paperwork Chapter 4
For 45 E the provider is always responsible for supplying the current and valid certificate of calibration for a temperature monitoring device
bull Tip If the temperature monitoring device has a sticker on the back with the calibration date the site can usually call the company who calibrated the device and get a copy of the certificate if they donrsquot have one
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 46 4 Storage amp Handling Per Unit Probe Placement
Question 46 Is the probe properly placed in this section of the storage unit
Note to Reviewer ldquoProperlyrdquo means that the probe in a commercial or household unit is placed in a central area of the unitdirectly with the vaccines Probes should not be placed in the doors near or against the walls close to vents or on the floor of the unit The only allowable exemption related to this requirement is for providerswho have pharmaceutical storage units (built for vaccine storage) that have either (1) a built-intemperature monitoring device OR (2) a dedicated port for the probe that dictates the placement of theprobe
Answers (Choose one)
Yes No [X]
Review CDC Requirement
The probe must be placed in a central area of the section of the storage unit directly with the vaccines in order to properly measurevaccine temperature The probe should not be placed in the door near or against the walls close to vents or on the floor of theunit For pharmaceutical units with a built-in temperature monitoring device or a dedicated port for a probe that is not in thecenter of the section of the storage unit consult your Immunization Program for guidance on placement
Goal of this question Make sure the temperature monitoring device is in the best location to accurately measure the temperature of the vaccines stored in the unit
Helpful information bull The probe of the temperature monitoring device should be placed directly with the vaccines in the middle of the unit The ONLY allowable exception is for pharmaceutical storage units that have either a built-in thermometer or a dedicated port for the probe that indicates placement of the probe
bull Temperatures can vary within the unit especially household units bull Call MDH at 651-201-5522 if you have questions
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Guide (wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml)
Page 38 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 474 Storage amp Handling Per Unit Temperature Documentation
Question 47 Review the temperature documentation over the past three months for this section of the storage unit todetermine whether the provider has a process in place for properly documenting temperatures twice aday Answer the questions below
A Are there two temperature readings recorded for this section of the storage unit per day
Yes No [X]
B Is there a time date and name (or initials) recorded for each reading Yes No [X]
C What is the current temperature and minmax temperatures (if available) inthis section of the storage unit Use the reviewerrsquos thermometer if the providerrsquos temperature monitoringdevice does not have a current valid certificate of calibration testing or the probe is not properly placed in this section of the storage unit
Current Temperature Minimum Temperature Maximum Temperature Fahrenheit Celsius
D Based on your review of the providerrsquos recent temperature documentationincluding the current temperature is this section of the storage unitmaintaining appropriate temperatures
Yes No [X] Not enough information [X]
Review CDC Requirement
Vaccines must be stored under appropriate temperatures as described in the package inserts at all times Acceptable temperature ranges vary by vaccine type and the range is 36deg F and 46deg F (2deg C and 8deg C) and for frozen vaccines the range is -58deg F and +5deg F (shy50deg C and -15deg C) Exposure to temperatures outside of those included in the package inserts could affect vaccine viability andultimately could leave children unprotected against vaccine-preventable diseases In order to maintain awareness of storage unittemperatures and ensure that vaccines are being stored at appropriate temperatures at all times VFC providers are required to monitor and document temperatures for all vaccine storage units at least twice a day Temperature documentation must contain (1) at least two temperature readings per day (2) the time and date of each reading and (3) the name (or initials) of the personwho assessed and recorded the readings CDC also recommends that VFC providers record the minimum and maximumtemperatures of each unit once each workday (preferably in the morning)
Goal of this question Ensure the temperature is being monitored twice daily is within the required range and documented correctly Use your thermometer to check the temperature if the sitersquos temperature monitoring devicersquos probe is not properly placed or there is not a current certificate of calibration Place your thermometer in the unit at the beginning of the visit to allow sufficient time to reach an accurate temperature The purpose of using your thermometer is to ensure the vaccine is being stored at the proper temperature not to ldquovalidaterdquo their reading
Question 47 D is an assessment question based on information you have learned during your visit You might answer ldquonot enough informationrdquo if the unit is new and they donrsquot have at least three months of data or if the unit is only used as overflow and they are inconsistent with temperature monitoring Mark ldquoNordquo if you have reason to believe the storage unit is not maintaining temperatures properly
Helpful information bull All sites must document temperatures twice a day every day the site is open even if they have a data logger or continuous monitoring system
bull Sites can document the information electronically with some continuous monitoring systems as long as it can show what the current temp is the date time and initials of the person checking ndash this needs to be someone at the site ndash not checking remotely or centrally for a large site or system The site must be able to produce these records during their site visit Reviewing these files can be a challenge due to large volumes and lots of paper
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Temperature Logs on Managing Vaccine (wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml)
IPI Advisor Manual | February 2017 Page 39
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 484 Storage amp Handling Per Unit Temperature Excursions
Question 48 In the event that a temperature excursion(s) occurred in this unit within the last three months requestand review documentation of actions taken to determine whether the provider has a process for properlyaddressing excursions Answer the questions below
A Were vaccines in this unit exposed to out-of-range temperatures in the lastthree months (including today)
Yes No (If no skip to question 49)
B Did the provider quarantine and label vaccines as ldquoDo not userdquo Yes No [X]
C Did the provider place vaccine in a unit where it can be stored under properconditions if applicable
Yes No [X]
D Did the provider contact the Immunization Program to report theexcursion
Yes No [X]
E Was the manufacturer contacted for documentation supporting theusability of the vaccine
Yes No [X]
Review CDC Requirement
The provider must document all excursions and actions taken including the following (1) Quarantine and label vaccines as ldquoDO NOTUSErdquo (2) Place vaccines in a unit where they can be stored under proper conditions (3) Contact the Immunization Program to report an excursion and (4) Contact the vaccine manufacturer to obtain documentation supporting the usability of the vaccine
Goal of this question Address any out-of-range temperatures (temperature excursions) identified in reviewing the last three months of temperature logs or during the site visit If there were any out-of-range temperatures did the site respond appropriately to the situation This is a great opportunity to discuss what to do in the event of an excursion The Clinicians Storage and Handling Mishap Checklist is in the IPI Site Visit information folder and is a good review of the process
Helpful information bull Sites need to know that an excursion does not automatically mean that exposed vaccines are non-viable or unusable Exposed vaccines must be quarantined (marked ldquoDo Not Userdquo) and stored under proper conditions until they have received information from vaccine manufacturers regarding the viability of the vaccine
bull Sites must inform MDH when an excursion occurs
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Clinicians Storage and Handling Mishap Checklist (wwwhealthstatemnusdivsidepcimmunize ipivaxchklstpdf)
Page 40 IPI Advisor Manual | February 2017
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Question 49
Goal of this question Ensure proper placement of vaccines in the storage unit
Note These are all recommendations (best practices) not requirements
Helpful information bull Store vaccine in the middle of the compartment two to three inches away from the coils walls floor and cold air vent The temperature near the floor and walls of the unit differs from that in the middle of the compartment and the cold air vent can freeze refrigerated vaccines
4 Storage amp Handling Per Unit Vaccine Placement
Question 49 Look inside the unit to answer the questions below
A Are vaccines placed in the middle of the unit with space between vaccinesand the sideback of the unit to allow cold air to circulate
Yes No [O]
B Are vaccines stored in their original packages Yes No [O]
C Are there water bottles (for refrigerators) or frozen water bottles (forfreezers) in the unit
Yes No [O]
D Are vaccines store in the doors vegetable bins under or near cooling ventsor on the floor of the unit
Yes [O] No
E Is food being stored in the unit Yes [O] No
Review CDC Recommendation
Vaccines should be stored in their original manufacturer (or CDC centralized distributor) packaging They should be placed in the middle of the unit with space between the vaccines and the sideback of the unit to allow cold air to circulate Vaccines SHOULD NOT be stored in the doors vegetable bins or floor of the unit or under or near cooling vents and there should not be any food inthe unit Water bottles (for refrigerators) or frozen water bottles (for freezers) should be placed throughout each storage unit inorder to (1) stabilize or extend temperatures during a power outage and (2) to serve as physical blocks preventing the placementof vaccines in areas of the unit that are at higher risk for temperature excursions (such as in doors vegetable bins floor ornearunder cooling vents)
bull Vaccines should be kept in their original packaging to Protect them from light Help prevent medication errors by making labels easier to read Provide a moisture barrier that serves as insulation in case of an out-of-range temperature power outage door left open or mechanical failure Simplify managing vaccine inventory
bull Store water bottles in the doors on the floor and near the cold air vent in the refrigerator and frozen water bottles in the freezer to help maintain a stable temperature if there is a power failure and when the door is opened frequently Too many water bottles in the door can prevent the door from closing tightly Mark water bottles ldquoDo Not Drinkrdquo
bull Do not store vaccine in the door or drawers of the refrigerator or freezer Vegetable bins and crisper drawers should be removed from refrigerators or used to store other medical supplies or water bottles
bull If vaccine is stored in a household combination refrigeratorfreezer The top shelf should not be used for storing vaccine because the cold air vent blowing from the freezer will freeze vaccine located there If you must use the top shelf of this type of unit place water bottles underneath the cold air vent to prevent vaccine from being stored there It is recommended that only the refrigerator be used for vaccine storage and a separate stand-alone freezer be used to store frozen vaccine
bull Must not store food or beverages in the refrigerator or freezer because frequent opening of doors can lead to temperature variations that may affect vaccine viability There is also a risk of contaminating vaccines
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Guide (wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml) bull Vaccine Storage Tip Sheet on IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml)
IPI Advisor Manual | February 2017 Page 41
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 4104 Storage amp Handling Per Unit Disconnection from Power Source
Question 410 Ask the provider to demonstrate what measures are taken to ensure that vaccine storage units are notaccidentally physically disconnected from the power supply Which of the following describes the measure(s) taken on this unit
Note to Reviewer bull Large hospitals and healthcare systems may not have the ability to demonstrate labels on plugs or circuitbreakers In such cases verify that the practice has a comprehensive policy and standard operatingprocedures in place to prevent the vaccine storage unit from being physically disconnected from thepower supply
bull While back-up generators may ensure power to the overall facility this question ONLY addresses thevaccine storage unit being accidentally disconnected from the power source either through the plug orthe circuit breaker
Answers A ldquoDo not disconnectrdquo labels on the plug (Choose all that B ldquoWarningrdquo label on the circuit breaker box
apply) C Hard-wired (ie built-in) and has a ldquoDo not disconnectrdquo label on thecircuit breaker box D Hospital or large health care system with a comprehensive written policyand standard operating procedures detailing measures taken to preventvaccine storage units from being accidentally disconnected from the powersupply E No acceptable measures for preventing accidental disconnection frompower supply [X]
[X] The response is non-compliant if only A only B or E is selected
Review CDC Requirement
VFC providers must take steps to protect the power source for all vaccine storage equipment by means of having clear warninglabels on both the plug and the circuit breaker associated with all vaccine storage units Large hospitals and healthcare systems canmeet this requirement by demonstrating that they have comprehensive policies and standard operating procedures to preventvaccine storage units from being physically disconnected from the power supply
Goal of this question Decrease the chance that a vaccine storage unit will be accidently unplugged or power will be turned off while vaccine is in the unit This question addresses only what measures the site has taken to ensure the storage unit is not physically disconnected from its power source
If the site uses labels on the plugs and circuit breakers perform a visual inspection to assess whether the way the stickers are positioned make it clear and obvious to anyone that these units are not to be disconnected
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Do Not Unplug and Warning stickers are included in the folder or available to order on the For
Professionals Order Form (wwwhealthstatemnusdivsidepcimmunizeordermathtml)
Note Once you have completed the 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet for each unit return to the questionnaire to complete sections 5 and 6
Page 42 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
- -
Section 5 Storage amp Handling Site-Wide Question 51
5 Storage amp Handling Site Wide Discussion of Cost amp Quantity of Vaccine
Question 51 Have a discussion with the provider about the cost and quantity of VFC vaccines they are responsible for annually Address the points listed in the note to reviewer below
Note to Reviewer bull Vaccine Shipped (Required) Share the cost of VFC vaccines shipped to the provider in the last calendaryear to make sure the provider understands the contribution made by the VFC Program to their practiceFor new providers who do not have ldquocalendar yearrdquo data share either the actual cost of their currentinventory or use the cost of 10 VFC doses of each of the ACIP-recommended vaccines (approximately $7000) to help estimate their annual cost
bull Storage amp Handling (Required) Make sure the provider understands the cost of vaccines for which they are responsible when they make decisions about purchasing recommended vaccine storage and temperature monitoring equipment
Answer I have discussed with the provider the cost and quantity of vaccines ordered in the previous calendar year
Goal of this question Inform sites of the quantity and value of vaccines that they receive as part of the MnVFC program Providers often donrsquot realize the value of the vaccine in their unit This information is included on your clinic list and on the one page site-specific information
Helpful information bull This discussion must occur and the box on the questionnaire must be checked bull If there isnrsquot actual vaccine value information available tell the site that one vaccine order that includes a box of each of the ACIP recommended vaccines costs approximately $7000
bull MDH may not have specific information for individual sites if they receive vaccine from a central warehouse or pharmacy For those sites MDH will give you numbers for the whole system so you can discuss system wide data as appropriate If individual site information is also included it is usually just varicella-containing vaccines that must be shipped directly to the site
Question 52
5 Storage amp Handling Site Wide Dorm Style Units
Question 52 Determine whether the provider has any dorm-style units on site and answer the questions below
Note to Reviewer A dormitory-style refrigerator is a unit that has both refrigerator and freezer compartments behind a singleexterior door Dorm-style units also have an evaporator plate (cooling coil) which is usually located insidean icemaker compartment (freezer) within the refrigerator
A Does the provider have any dorm-style units that are used at any time tostore vaccines
Yes [X] No (Skip to question 53)
B Does the provider have sufficient space in existing compliant vaccinestorage units to store all vaccines without use of the dorm-style unit at any time
Yes No [X]
Review CDC Requirement
Dorm- and bar-style units are prohibited for vaccine storage Vaccines stored in dorm-style units are considered non-viable and must be returned to the centralized distributor CDC recommends the following vaccine storage unit types (in order of preference)pharmaceutical grade stand-alone or combination units (preferred) householdcommercial stand-alone unitshouseholdcommercial combination units using the refrigerator section only
Goal of this question Ensure no vaccine is stored in dorm-style units even for short periods of time Encourage them to label any units ldquoNo Vaccine Storage Allowedrdquo Vaccine stored in these units is considered non-viable If a site is using a dorm-style unit call the MnVFC program (651-201-5522)
Resource Section 8 in the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 43
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 535 Storage amp Handling Site Wide Storage Unit Space Availability
Question 53 Does the provider have sufficient room across storage units to store current stock as well as anyadditional stock acquired during peak season without overcrowding
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have sufficient storage space to accommodate vaccine stock at the busiest time of year without overcrowding
Goal of this question Ensure that sites have sufficient space in their units to maintain vaccines at the busiest time of year Overcrowding of vaccine limits air circulation and affects the unitrsquos ability to maintain stable temperatures
Helpful information bull Look for signs of overcrowding such as vaccines that are pushed up against the wall bins that are overflowing or storage units that are full during non-peak seasons
Discuss immediate actions if the unit is overcrowded Move some of their vaccines order less vaccine more frequently (once per month preferably) andor purchase another storage unit for overflow
Resource bull Section 8 MnVFC Policy and Procedure Manual
Page 44 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 545 Storage amp Handling Site Wide Expired Vaccines
Question 54 Look in each unit Are there expired vaccines in any of the vaccine storage units at this site
Answers (Choose one)
Yes [X] No
Review CDC Requirement
Vaccines should be rotated weekly and when a new shipment comes in so that longer-dated vaccines are stored behind shorter-dated vaccines If vaccines expire they can no longer be stored in the same storage unit with viable vaccines They must be placedin a container or bag clearly labeled ldquoDo not userdquo and separated from viable vaccines to prevent inadvertent use Expired vaccinemust be returned to the centralized distributor within six months of expiration
Goal of this question Ensure there is no expired vaccine in any storage unit
Helpful information bull Sites can prevent their stock from expiring by rotating vaccines every week andor when a new shipment arrives Longer-dated vaccines are stored towards the back of the unit and shorter-dated vaccines are up front
bull Pay attention to vaccines that expire within the next three months Consider transferring vaccine that will expire soon to another MnVFC-enrolled site that will use the vaccine preferably a site close by It is the transferring sitersquos responsibility to arrange the transfer of the vaccine Be sure to complete the MDH Vaccine Transfer Record form and send it to MDH If they are having difficulty finding a location to accept vaccine contact MDH
bull This is a great opportunity to educate sites about the MDH Nonviable Vaccine Form and the process for returning vaccine The VFC program does get some credit for taxes and fees on vaccine that is returned to the distribution center
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MDH Nonviable Vaccine Form and MDH Vaccine Transfer Record on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfcformshtml)
IPI Advisor Manual | February 2017 Page 45
The 2017 MnVFC Site Visit Paperwork Chapter 4
- -
-
Question 555 Storage amp Handling Site Wide Back up Thermometer
Question 55 Does the provider have a readily available back-up thermometer with a current and valid certificate ofcalibration testing
Note to Reviewer ldquoReadily availablerdquo means that the thermometer is available to perform twice-a-day monitoring for a unit asrequired CDC recommends that the back-up thermometer be maintained on site
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have a readily available back-up thermometer with a current and valid certificate of calibration testing Toprevent the certificates of calibration testing of the primary and back-up thermometers from expiring at the same time the date of calibration testing (or issue date) of the back-up thermometer should be different from the date of calibration testing (or issue date) of the primary thermometer As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meetsVFC program requirements
Goal of this question Ensure sites have one calibrated back-up thermometer onsite that is readily available in the event that the temperature monitoring device in unit fails transportation of vaccine is needed or there are other unexpected circumstances
Helpful information bull As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meets VFC Program requirements
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 56 5 Storage amp Handling Site Wide Preparation of Vaccine
Question 56 When does this provider prepare vaccine for administration to the patient
Note to Reviewer For mass vaccination clinics if one type of vaccine is offered providers may pre-draw up to 10 doses Ifusing pre-filled syringes pre-drawing also means activating the syringe by removing the needle guard orattaching a needle
Answers (Choose all that
apply)
Prepare dose immediately before administration Pre-draw doses for upcoming patients (in a regular clinicpractice) [O] Pre-draw up to 10 doses (in a mass-vaccination clinic) Pre-draw more than 10 doses (in a mass-vaccination clinic) [O] Other [O]
Review CDC Recommendation
CDC recommends preparing vaccines immediately prior to administration in order to assure viability of vaccine and prevent vaccinewastage Vaccines that are not administered immediately are at risk of exposure to temperatures outside of the required rangewhich can affect vaccine viability and ultimately can leave children unprotected against vaccine-preventable diseases
Goal of this question Discuss proper timing and preparation of vaccine(s) for administration These are recommendations not requirements
Helpful information bull Educate staff on the importance of preparing vaccine immediately before administration Pre-drawing of vaccines may lead to concerns related to vaccine viability potency sterility and wastage
Page 46 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 6 Inventory Question 61
6 Inventory Inventory Comparison
Question 61 Visually inspect storage units to determine if existing supply of vaccines proportionately mirrorspopulations served Choose the most accurate statement below
Note to Reviewer bull CDC recommends that providers maintain a four-week supply of inventory bull For this question do not take into account vaccine types that the provider does not order Here simply
make sure that overall the vaccines in the providerrsquos storage units are available in sufficient amounts toserve their patient population
Answers (Choose one)
The current vaccine inventory proportionately reflects the populations identified Only public stock is insufficient [X] Only private stock is insufficient [X] Both public and private stock are insufficient [X] Site uses the replacement method but does not appear to have enough vaccine for their population [X] Other [X]
Review CDC Requirement
VFC providers must order and stock routine vaccines in accordance with their patient population in order to prevent missedvaccination opportunities Having sufficient amounts of all stocks prevents the inadvertent use of VFC vaccines for non-VFC-eligiblepatients and vice versa
Goal of this question Assess whether the site is ordering appropriate quantities of vaccine for the population they serve at their site
Helpful information bull If the site sees 30 percent private-pay patients and 70 percent VFC the stock in their storage units should reflect that proportion If you donrsquot know you can ask the site about their population
bull This is meant to be a general assessment so in a big site if they have only a small amount of vaccine that may indicate an issue with vaccine management
bull CDC recommends smaller more frequent orders (ie monthly) rather than large orders to minimize the amount of vaccine loss if an incident occurs during shipment or in the storage unit Sites should not order more frequently than once a month
bull Sites using the replacement method will only have one stock but it should appear to be large enough for their population
bull Only assess the vaccine types that the site currently stocks in their unit We know there are sites that do not offer all ACIP-recommended vaccines for various reasons That issue will be addressed in question 62
IPI Advisor Manual | February 2017 Page 47
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 626 Inventory ACIP Recommended Vaccines
Question 62 Review providerrsquos current inventory to answer the questions below
A Does the provider offer all routine ACIP-recommendedvaccines for their patient population
Yes (Skip to question C) No [X] Offers all except varicella because direct ship ofvaccine is unavailable from manufacturer
B Which routine vaccines are NOT being offered DTaP Hepatitis A Hepatitis B HIB HPV Influenza Meningococcal
MMR Pneumococcal Polio Rotavirus TdapTd Varicella
C According to Immunization Program Policy does theprovider make accessible all non-routine ACIP-recommended vaccines for those VFC patients whomeet the criteria for receiving them
Yes (Skip to question 63) No [X]
D Which non-routine vaccines are NOT being offered Pneumococcal polysaccharide vaccine (PPSV23) Meningococcal Group B (MenB) Other
Review CDC Requirement
VFC providers agree to comply with immunization schedules dosages and contraindications that are established by the Advisory Committee on Immunization Practices (ACIP) for the vaccines identified and agreed upon in the Provider Agreement UNLESS bull In the VFC providers medical judgment and in accordance with accepted medical practice the VFC provider deems such
compliance to be medically inappropriate for the child bull The particular requirements contradict state law including laws pertaining to religious and other exemptions The VFC program entitles children to the following vaccines DTaP Hepatitis A Hepatitis B HIB HPV Influenza MeningococcalMMR Pneumococcal Polio Rotavirus TdapTd and Varicella VFC providers are also required to ensure that VFC-eligible children have access to non-routine vaccines as needed
Goal of this question Assess if the site is offering all the ACIP-recommended vaccines for the population they serve and these vaccines are in stock on the day of the visit It is important that every MnVFC-eligible child that comes to a providerrsquos office for an immunization is vaccinated
Helpful information bull The Advisory Committee on Immunization Practices (ACIP) is a group of medical and public health experts that develops recommendations on how to use vaccines to control diseases in the United States
bull Specialty providers are not required to offer all routine vaccines but should provide the vaccines appropriate for their population
bull If the site does not offer all routine ACIP-recommended vaccines appropriate for their population check the ldquoNordquo box in Part A then check the appropriate box(es) in Part B for any vaccines not offered Please contact MDH as this situation offers us the opportunity to provide education to the site
bull For non-routine vaccines they must either be in stock or the site must have an alternative protocol in the routine management plan that ensures these children have access when applicable
Resources bull IAC Diseases and Vaccines (wwwimmunizeorgvaccines) bull CDC Advisory Committee on Immunization Practices (ACIP) (wwwcdcgovvaccinesacipindexhtml)
Page 48 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 636 Inventory Separation of Stock
Question 63 Observe how the provider differentiates stock in each storage unit to answer the questions below
A Is it clear which vaccines belong to public stock andwhich belong to private stock
Yes No [X] Not applicable replacement site
B Is it clear which vaccines belong to VFC stock andwhich belong to UUAV stock
Yes No [X] Not applicable replacement site Not applicable not UUAV-enrolled site
Review CDC Requirement
In order to ensure that VFC vaccines are only administered to VFC-eligible children VFC providers that serve both VFC and non-VFCshyeligible children must maintain their vaccine inventories in such a way that they can clearly differentiate public stock from privatestock as well as VFC from other public stock
Goal of this question Assess whether the site can distinguish between MnVFC vaccine and private vaccine If they participate in the Uninsured and Underinsured Adult Vaccine (UUAV) program they should also be able to distinguish between MnVFC stock and UUAV stock Some sites use labels bins boxes etc to differentiate their stock If it is not clear how the site differentiates their stock discuss vaccine management with the staff For follow-up call MDH to discuss doing a follow-up site visit
Sites using the replacement method will not have separate stocksmdashthis is an approved alternative method for keeping track of vaccine
Resource bull Section 10 of the MnVFC Policy and Procedure Manual
IPI Advisor Manual | February 2017 Page 49
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
MnVFC Site Visit Storage and Handling Per Unit Answer Sheet 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet MnVFC PIN ___________________
Question number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
Temperature Monitoring Device Questions Questions 43 47 must be answered separately for the freezer and refrigerator if the unit is a combo Be sure to document responses in the appropriate column
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
All the questions on the Site Visit Storage amp Handling Per Unit Answer Sheet have been discussed previously in section 4 of this manual Use this sheet to record information about all the units at the site visit You will need one sheet for each unit If it is a combination unit (either pharmaceutical or household) you can record both sections on one sheet If they have stand-alone units use one sheet for each unit Do not enter the answers to the questions in section 4 of the questionnaire
If you need more information about any of the questions refer back to the main questionnairemdashthe complete question additional guidance including notes to the reviewer and the CDC requirements are there Also if the site is not meeting the requirement you will go back to the questionnaire to complete the ldquoActions if Non-compliantrdquo section including the root cause analysis and follow-up sections
When you have completed the assessment of all the storage units remember to go back to the questionnaire to complete sections 5 and 6
Page 50 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
ndash
ndash
MnVFC Provider Follow-up PlanThe goal of the Provider Follow-up Plan is to communicate with the site all of the VFC requirements any unmet requirements found during your site visit and the timeline for completing the required action The left hand column is a box to check for ldquoUnmetrdquo requirements
Helpful information bull The form can be used to review what the site is doing well and what they need to work on
bull For requirements that have specific documentation that needs to be sent to you use the notes section
2017 MnVFC Provider Follow-up Plan Site _______________________________________________ MnVFC PIN ____________ Date of Visit ___________
Thank you for participating in this MnVFC compliance site visit Please review this visit summary including follow-up actions and timelines for completion Unmet MnVFC requirements and recommendations have a checked box next to them The goal of this plan is to support you with successfully implementing the program and improving access to vaccines for VFC-eligible children
Unmet Question VFC Requirements Section 1 Changes to Key Staff
Q12 Change in the Medical Director Immunization Manager Vaccine Coordinator or back-upKey Staff must be communicated to the immunization program by emailing healthmnvfcstatemnus Changes Notes
Q12 Key staff must complete the annual training on VFC program requirements and print theAnnual Training certificate of completion Documentation Required Action
Staff that have not completed the MnVFC online training must complete it and send acopy of the certificate to the reviewer Training can be found on the MnVFC website (wwwhealthstatemnusvfc) Due date 1 month
Notes
Unmet Question VFC Requirements Section 2 Eligibility
Q21 Provider staff must possess a working knowledge of all VFC eligibility criteria and use thoseVFC Eligibility criteria to screen children prior to administering VFC vaccines
Categories Notes
bull This form provides documentation needed for follow-up actions when you send your thank you email
The second to last page of the Provider Follow-up Plan has a summary of the MnVFC program recommendations These are to remind the site about best practices they may want to improve upon even though they are not yet requirements of the program For example you could discuss the recommendation about storage units if they currently have a combination household unit and are using both sections
The last section is for your signature and the person you met with In most sites it will be the immunization manager or vaccine coordinator who signs the form unless the medical director attended the site visit You keep the original copy and the site will need to keep a copy for themselves
To be completed by the site visit reviewer
I acknowledge that a VFC site visit was performed on __________________ (visit date) The follow-up plan which includes a list of all current VFC program requirements and recommendations assessed during the visit and any required follow-up actions was provided at the end of the visit
Site visit reviewer
Phone
Reviewer Signature Date
To be completed by the provider
I acknowledge that our practice took part in the VFC site visit noted above I understand the findings of the visit and any required actions that must be taken by our office in order to meet VFC program requirements
Medical Director (or designee) Name Title
Medical Director (or designee) Signature Date
IPI Advisor Manual | February 2017 Page 51
The 2017 MnVFC Site Visit Paperwork Chapter 4
After the Site Visit Send a thank you email highlighting the unmet requirements documents you need from the site to resolve the issue(s) and the date you need them Make sure to include the link to the Site Visit Survey (httpssurveyvovicicomseashxs=56206EE334CE0B14)
Please refer to Chapter 3 for more information about future follow-up required after the visit including forms and documentation
Resource bull Sample Thank You letter on IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml)
Chapter 5
IPI Advisor Resource List MnVFC Program 651-201-5522
MnVFC wwwhealthstatemnusvfc
bull Separate Stock and Replacement Method Policies and Procedures Manuals bull Online trainings bull MnVFC Announcements sign up to receive them via email bull Ordering MDH vaccine bull MnVFC forms Screening forms Reporting forms Others MDH Nonviable Vaccine Form MDH Vaccine Transfer Record and Vaccine Borrowing Report
bull MnVFC promotional materials bull Immunization Billing Guidance for MnVFC and Immunization Billing Guidance for MnVFC Replacement Sites Immunization Practices Improvement Program (IPI) wwwhealthstatemnusdivsidepcimmunizeipi
bull IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml) bull IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml) IPI Resource Folder Contents (wwwhealthstatemnusdivsidepcimmunizeipiipifolderpdf)
Minnesota Immunization Information Connection (MIIC) wwwhealthstatemnusmiic
bull MIIC regions and regional coordinators
Clinical Practice MDH Immunization Program wwwhealthstatemnusimmunize
Got Your Shots News wwwhealthstatemnusdivsidepcnewslettersgys
MDH Immunization Information for Health Care Providers wwwhealthstatemnusdivsidepcimmunizehcp
bull Got Your Shots A Providers Guide to Immunization in Minnesota bull Vaccine protocols bull Forms for tracking patient immunizations bull Immunization schedules for Health Care Providers Immunization Action Coalition (IAC) wwwimmunizeorg
bull Ask the Experts bull VISs (Vaccine Information Statements and translations) bull Administration screening questions bull Medical management of vaccine reactions bull Order form for Californiarsquos Immunization Technique DVD Best Practices with Infants Children and Adults
Page 52 IPI Advisor Manual| February 2017
IPI Advisor Resource List Chapter 5
CDC ldquoPink Bookrdquo wwwcdcgovvaccinespubspinkbookindexhtml
CDC Advisory Committee on Immunization Practices (ACIP) wwwcdcgovvaccinesacip
CDC Vaccines and Immunizations wwwcdcgovvaccines
VAERS reporting httpvaershhsgovindex
Storage and Handling Got Your Shots Providers Guide ndash Managing Vaccine wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml
MnVFC Guide to Temperature Monitoring Devices wwwhealthstatemnusvfc
MDH Clinicianrsquos Vaccine Mishap Checklist wwwhealthstatemnusdivsidepcimmunizeipivaxchklstpdf
MDH Vaccine Storage Guide wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml
CDC Vaccine Storage and Handling Toolkit wwwcdcgovvaccinesrecsstoragetoolkit
You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Vaccine manufacturer phone numbers wwwcdcgovvaccinespubspinkbookdownloadsappendicesFcontact-info-manufactpdf
IAC Checklist for Safe Vaccine Handling and Storage wwwimmunizeorgcatgdp3035pdf
IAC Donrsquot Be Guilty of These Errors in Vaccine Storage and Handling wwwimmunizeorgcatgdp3036pdf
Additional Resources Print materials from MDH ndash order forms wwwhealthstatemnusdivsidepcimmunizeordermathtml
Vaccine Education Center ndash Childrenrsquos Hospital of Philadelphia wwwchopeduservicevaccine-education-centerhomehtml
California Department of Public Health ndash Interactive training on vaccine administration and storage and handling handout on transporting vaccine and how to package wwwezizorg
IPI Advisor Manual | February 2017 Page 53
IPI Advisor Resource List Chapter 5
CDC vaccine price list wwwcdcgovvaccinesprogramsvfcawardeesvaccine-managementprice-listindexhtml
Vaccine Information Statements (VIS) wwwcdcgovvaccineshcpvisindexhtml
CEU Opportunities CDC Immunization Education and Training wwwcdcgovvaccinesedindexhtml
Immunization You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Page 54 IPI Advisor Manual| February 2017
- Introduction
-
- Welcome to the Immunization Practice Improvement (IPI) Program
- Contact Information
-
- Chapter 1
- Requirements to Participate in the MnVFC Program
- Vaccines for Children Program
- Chapter 2
- Reimbursement for MnVFC Visits
- Types of Visits
- Your MnVFC Clinical CoordinatorPlanner
- New IPI Advisor Training Requirements
- Your Role as an IPI Advisor
- Reasons MDH Would Do All or Part of a Visit
- Chapter 3
- Future follow-up
- Conducting the Visit
- Preparing for the Visit
- Information for the Visit
- Site Visit Checklist
- Scheduling the Visit
- Chapter 4
- After the Site Visit
- MnVFC Provider Follow-up Plan
- MnVFC Site Visit Storage and Handling Per Unit Answer Sheet
- Section 6 Inventory
- Section 5 Storage amp Handling Site-Wide
- Section 4 Storage amp Handling Per Unit
- Section 3 Documentation
- Section 2 Eligibility
- Section 1 Provider Details
- The Site Visit Reviewer Legend
- MnVFC Site Visit Questionnaire
- Required Paperwork for Site Visits
- Chapter 5
-
Page 26 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 34
3 Documentation Borrowing Documentation
Question 34 Discuss borrowing practices with the provider to answer the questions below
Note to Reviewer bull To be considered ldquofully documentedrdquo documentation for each borrowed dose must include thefollowing information
Vaccine type borrowed Date the dose was administered Stock used (VFC or private) Reason appropriate vaccine stock was not used Patient name and date of birth Date dose was returned to appropriate stock
A Did the provider state that they had borrowed any vaccines (whetherdocumented or not) since the last VFC Compliance Site Visit
Yes No (If no skip to question 36)
B Are there any doses for which there is no documentation (ie provider hasindicated that doses were borrowed but cannot verify how many or why)
All doses are documented Some doses are not documented [X] No doses are documented [X] (if nodoses documented skip toquestion 36)
C Were all borrowed doses fully documented (See Note to Reviewer above) Yes No [X]
D Were all borrowed VFC doses either replaced or an order submitted to replacethe doses Yes No [X]
Review CDC Requirement
VFC providers are expected to maintain an adequate inventory of vaccine for VFC and non-VFC-eligible patients It is theresponsibility of the VFC provider to appropriately schedule and place vaccine orders VFC providers must also rotate stock to ensure timely use of short-dated vaccines Borrowing of vaccine between private and public inventories must be a rare unplanned occurrence and cannot serve as a replacement system for a VFC providerrsquos privately purchased vaccine inventory All instances ofborrowing must be properly documented reported and replaced
Goal of this question Assess vaccine accountability by verifying that children are receiving vaccine from the appropriate stock
Borrowing is when a fully insured child receives a dose of MnVFC vaccine or a MnVFC-eligible child receives a dose of private vaccine This should be a rare unplanned occurrence The site must document any borrowing of vaccine between stocks ideally on the VFC Borrowing Report Form If they are not currently using the form review it with them and encourage them to post it close to their vaccines It does not need to be sent to MDH but should be kept for 3 years and filed with their MnVFC documents to be reviewed whenever they have a regular or unscheduled (unannounced) site visit
Helpful information bull Understand and report on staffrsquos verbal (ie anecdotal) accounts of borrowing obtained during the visit Often sites do not know that what they do is considered borrowing or they think borrowing is acceptable and documentation isnrsquot needed so long as those vaccines are eventually replaced
bull Since sites using the replacement method only have one stock of vaccine they very rarely borrow bull This question asks for future follow-up in 6 months Make a note on your calendar and ask them to send you a copy of their borrowing reports for the previous 6 months with documentation of doses borrowed and replaced We will remind you if we donrsquot hear from you at the 6 month time frame Complete the Follow-up Form and attach the borrowing form
Resources bull Vaccine Borrowing Report on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfc formshtml)
bull Section 10 of the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 27
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 353 Documentation Borrowing Reasons
Question 35 Based on your discussion with the provider and a review of borrowing reports document the dosesborrowed for each reason and answer the questions below
Note to Reviewer bull Short-dated vaccines are doses that are likely to expire before they can be used bull Exchanging short-dated vaccines should only occur in practices that have a small number of private
patients
A Reasons for Borrowing a VFC Dose (Enter the number of _____ Private vaccine shipment delay (order placed on time but delay in shippingreceipt)
vaccine doses borrowed for each
reason in the spaces
_____ Private vaccine not useable on arrival (vials broken temperature monitor out of range) _____ Ran out of private vaccine between orders (provider orders not placed on time) [X]
provided) _____ Short-dated private dose was exchanged with VFC stock _____ Accidental use of VFC dose for a private patient (human error) _____ Replacement of private dose with VFC when insurance plan did not cover vaccine _____ OtherDocumented dose did not include reason for borrowing [X]
(Explanation Required) Reasons for Borrowing a Private Dose _____ VFC vaccine shipment delay (order placed on time but delay in shippingreceipt) _____ VFC vaccine not useable on arrival (vials broken temperature monitor out of range) _____ Ran out of VFC stock between orders (provider orders not placed on time) [X] _____ Short-dated VFC vaccine dose was exchanged with private dose _____ Accidental use of a private dose for a VFC-eligible patient (human error) _____ OtherDocumented dose did not include reason for borrowing [X]
(Explanation Required)
B Enter date range for instances of borrowing reviewed in the borrowing report Note If ldquoDate of earliest instancerdquo is not available use the date of the last VFC Compliance Visit If ldquoDate of last instancerdquo is not available use the date of thecurrent VFC Compliance Visit
Date of earliest instance
Date of last instance
C Does borrowing appear to be a routine practice Note To determine whether borrowing is a routine practice assess frequency of and repeating reasons for borrowing Examples Frequent accidental use of incorrect stock exchanging short-dated vaccines or issues with ordering and shipment
Yes [X] No
Goal of this question Determine the reasons why the site is borrowing vaccine
If sites are using the Vaccine Borrowing Report review the reasons for borrowing to help document borrowed VFC andor private doses If they have not been documenting borrowing on this report (or any other form) estimate their borrowing practices If you do not know the date range for their borrowing use the last site visit date to the current visit date The use of ldquootherrdquo as the reported reason for borrowing should be rare if ever and would require explanation and follow up
Helpful information bull Look to see if they routinely maintain insufficient amounts or types of vaccine to support their public and private patients that leads to borrowing
bull Pay attention to borrowing cases documented as ldquoaccidentalrdquo Repetitive accidental borrowing may indicate an issue with ordering processes or insufficient staff training
bull Borrowing is not a place to document wasted or lost doses bull The time period of the borrowing may give you clues about the root cause Were the borrowed doses concentrated in a short period or spread out across several months or a year Are all vaccine types being borrowed or just one
bull If borrowing seems to be an issue discuss vaccine management ordering procedures
Resources bull Vaccine Borrowing Report on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfc formshtml)
bull Section 10 in the MnVFC Policies and Procedures Manual
Page 28 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 36
3 Documentation Vaccine Management Plan
Question 36 Physically review the providerrsquos Vaccine Management Plan to answer the question below
A Does the provider have a Vaccine Management Plan Yes No [X] (If no skip to question 37)
B Does the plan list the current Immunization Manager Vaccine Coordinator andback-up
Yes No [X]
C Does the plan address proper vaccine storage and handling practices Yes No [X]
D Does the plan specify vaccine receiving procedures Yes No [X]
E Does the plan contain procedures for what to do with vaccine in the event of an emergency
Yes No [X]
F Does the plan contain procedures for vaccine ordering Yes No [X]
G Does the plan address inventory control (example stock rotation) Yes No [X]
H Does the plan address how to handle vaccine wastage Yes No [X]
I Does the plan address staff training and documentation on vaccine managementstorage amp handling
Yes No [X]
J Does the plan contain a review date that falls within the last 12 months Yes No [X]
K Has the plan been signed by the individual responsible for its content Yes No [X]
Review CDC Requirement
VFC providers must develop maintain and implement a Vaccine Management Plan for routine and emergency vaccinemanagement The plan must contain the current Vaccine Coordinator and back-up proper storage and handling practicesshipping and receiving procedures emergency procedures procedures for vaccine ordering inventory control (eg stock rotation)how to handle vaccine wastage and staff trainingdocumentation on vaccine management storage and handling The plan must bereviewedupdated annually or more frequently if changes occur A ldquoreview daterdquo and signature are required on all plans in order tovalidate that they are current
Goal of this question Evaluate the sitersquos plan for vaccine management It is especially important that they have a plan for emergency management of their vaccine in the case of equipment failure or power outage Encourage all sites to read and sign the MnVFC Policies and Procedures Manual and complete the emergency plan or be able to show you a plan of their own
If the provider is not able to physically show you the plan at the time of the visit or if the recorded review date is not within the last 12 months you must mark that this requirement is unmet The Vaccine Management Plan is important in times of emergency and it should be easy to access by any staff member at any time Encourage them to post the plan and put a copy with the packing supplies
Helpful information bull Encourage the site to fill in the ldquoImmunization Managerrdquo and ldquoVaccine Coordinatorrdquo fields in the
MnVFC Policies and Procedures Manual for their own referencebull The emergency plan in the manual can be reviewed from last year and included in this yearrsquos manual (with an updated signature and date) if there have not been any changes
bull If information in the plan is outdated site staff will not be well equipped to safely manage vaccines in the event of a power-outage or other emergency situation
bull If their institutional policy is only reviewed and updated every 3-4 years (as many are) the staff may need to sign the MnVFC Polices and Procedure Manual to meet this requirement
Resource Routine Vaccine Management Plan and Emergency Vaccine Management Plan in the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 29
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 37
3 Documentation VIS amp VAERS
Question 37 Review the providerrsquos Vaccine Information Statements (VISs) and discuss providerrsquos VAERS process toanswer the questions below
A Does the provider have readily available up-to-date VISs for all ACIP-recommendedvaccines relevant to the populations it serves
Yes No [X]
B Does the provider make a VIS available for patientsparents before eachvaccination
Yes No [X]
C Does the provider know how and when to report clinically significant adverseevents using VAERS
Yes No [X]
Review CDC Requirement
VFC providers are required to distribute the current Vaccine Information Statements (VIS) each time a vaccine is administered and maintain records in accordance with the National Childhood Vaccine Injury Act (NCVIA) which includes reporting clinicallysignificant adverse events to the Vaccine Adverse Event Reporting System (VAERS) For a list of current VISs visit CDCrsquos Vaccine Information Statements (httpwwwcdcgovvaccineshcpvis) website
Gal of this question Ensure the site has the most current VISs and is giving them to each patientparent before administering the vaccine in compliance with the federal law Parents must be educated about the vaccine their child will receive and be aware of possible contraindications and side-effects in order to make well-informed decisions about their childrsquos health
Helpful information bull Ask to see the sitersquos VISs to determine if they have an active protocol for giving VISs to parents Review to make sure they are current Ask if they know where and how to report vaccine adverse events
Resources bull Section 3 in the MnVFC Policies and Procedures Manual bull CDC Vaccine Information Statements (wwwcdcgovvaccineshcpvisindexhtml) Site may sign up for email updates for the current list of VIS publication dates for the most up-to-date version
bull IAC Itrsquos Federal Law You must give your patients current Vaccine Information Statements (wwwimmunizeorgcatgdp2027pdf)
bull VAERS (httpsvaershhsgovindex)
Question 38
3 Documentation Anaphylaxis protocol
Question 38 Does the site have an anaphylaxis protocol which is clearly posted near the emergency kit
Answers (Choose one)
Yes No [X]
Review CDC Requirement
An anaphylaxis protocol must be clearly posted in the area where vaccines are administered
Goal of this question Make sure site is prepared for a severe allergic or anaphylactic reaction to a vaccine
Resources bull Section 11 in the MnVFC Policies and Procedures Manual bull IAC protocols Child and Teens (wwwimmunizeorgcatgdp3082apdf) and Adults (wwwimmunize orgcatgdp3082pdf)
Page 30 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
i
i i i - li i i i i i l
Section 4 Storage amp Handling Per Unit The goal of this section is to assess vaccine storage
2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet practices in each unit at the site MnVFC PIN ___________________
The 2017 MnVFC Storage amp Handling Per Unit Answer Sheet is a worksheet to document the answers to the questions in this section for each unit (combination or stand-alone) Fill in the answers to the questions in Section 4 on the answer sheet not in the questionnaire
The answer sheet has an abbreviated form of each question If you need further information on that question refer back to the full questionnaire Also if you find an area where the site is not meeting the requirements you will need to go back to that question on the 2017 MnVFC Site Visit Questionnaire to complete ldquoActions if Non- compliantrdquo section including the root cause analysis and follow-up sections If there is a problem in more than one unit make a note on the questionnaire which unit you are referring to in the Notes section
Important You must fully assess any unit that may be used to store VFC vaccines even if there are no VFC vaccines there on the day of the visit If there are no vaccines and the site is not documenting twice a day temperatures discuss the need to ensure the unit is maintaining stable temperatures by monitoring for one week before placing vaccines in the unit
Quest on number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
for the freezer and e co umn
Temperature Monitoring Dev refr gerator f the un
ce Quest ons Quest ons 4 3 4 7 must be answered separate y t s a combo Be sure to document responses n the appropr at
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
44D Data downloaded and reviewed routinely (eg weekly)
Yes No [O]
Yes No [O]
45A Certificate of Calibration Testing Yes No [X]
Yes No [X]
45B Date of calibration
45C Date certificate expires [X] Follow-up is required if expired [X] Follow-up is required if expired
45D Certificate contains all necessary items
Yes No [X]
Yes No [X]
46 Probe properly placed Yes No [X]
Yes No [X]
47A Two temperature readings per day
Yes No [X]
Yes No [X]
47B Time date and name (or initials) for each reading
Yes No [X]
Yes No [X]
47C Current temperature and minmax temperatures (if
Current ________deg Minimum ________deg Maximum _deg
Current ________deg Minimum ________deg Maximum _deg
Sections 5 and 6 contain questions about storage and handling site wide and inventory It is helpful to keep those questions in mind as you assess the individual storage units Think about dorm-style units expired vaccine vaccine supply room for vaccine stocking all the recommended vaccines and separation of stock if appropriate
NOTE The sections that follow require reviewers to validate responses by looking at vaccine storage units temperaturemonitoring equipment and the vaccine inventory inside a unit bull For section 4 use a separate Storage amp Handling Per Unit Answer Sheet for each unit to document the findings (combination
units using both sections can be documented on the same answer sheet) bull When an unmet requirement is identified return to this questionnaire to complete the ldquoActions if Non-compliantrdquo section for
that question bull After you complete one answer sheet for each unit return to the questionnaire to complete sections 5 and 6 using information
you gathered while assessing the units The questions in sections 5 and 6 (Storage amp Handling Site-Wide and Inventory) are notunit-specific but do require that the response be based on a thorough assessment of all the providersrsquo units
4 Storage amp Handling Per Unit
Description On the Storage amp Handling Per Unit Answer Sheet place a name that will allow you or someone else from your program to easily identify this unit in the event of follow-up We recommend using Brand + Location(example Samsung - Room 123) Save each Storage amp Handling Per Unit Answer Sheet with the Brand + Location in the file name
(example SamsungRoom123doc)
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The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 41
4 Storage amp Handling Per Unit Storage Unit Build amp Use
Question 41 Below select the build and use of the vaccine storage unit you are assessing
Note to Reviewer Dorm-style units Do not add dorm-style units here Dorm-style units will be addressed in section 5 Units storing only private stock You must review these storage units even if they contain only private stockat the time of the visit because that vaccine could be administered to VFC patients
A What type of unit is this A Stand-alone B Combination
B Select use if stand-alone A Freezer B Refrigerator
Select use if combination A Use both sections to store vaccine B Use freezer section only to store vaccine C Use refrigerator section only to store vaccine
Goal of this question Identify the unit you are evaluating The description asks you to create a unique name for this unit so that you will be able to identify the same unit in future site visits Put this description on the top of the answer sheet (ie make and location)
Helpful information bull A stand-alone unit is either a refrigerator or a freezer It does not have both sections in the unit bull If there is a combination unit note if the site uses both the refrigerator and freezer or only one section of the unit to store vaccines CDC does not recommend the use of either section or the freezer section only of combination household units
bull If your site utilizes the separate stock method of vaccine management you must review storage units even if they contain only private stock at the time of the visit because there is a chance that those vaccines could be administered (borrowed) to VFC-eligible patients
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The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 424 Storage amp Handling Per Unit CDC Recommended Storage Units
Question 42 Below document the grade of the vaccine storage unit you are assessing
Note to Reviewer Pharmaceutical Also called ldquopurpose-builtrdquo these units are designed by the manufacturer specifically tostore vaccines or other biological materials Commercial Although usually intended to store food and beverages commercial units are often larger and more powerful than the household units found in most homes Though these units are intended to meet thehigher demands of larger facilities these units are not specifically built for the storage of biologicalmaterials Household (non-commercialdomestic) These units are usually smaller than commercial units and areintended for use in small offices and in homes ndash typically for food storage However just like commercialunits they are not designed specifically for the storage of biological materials Such units are usually available in common home supply stores
Answers (Choose one)
Select grade A Pharmaceutical B CommercialHousehold
[O] CDC does not recommend the use of both sections or the freezer section only of combination commercialhousehold units
Review CDC Recommendation
CDC recommends the following vaccine storage unit types (in order of preference) pharmaceutical grade stand-alone orcombination units (preferred) householdcommercial stand-alone units householdcommercial combination units using therefrigerator section only
Goal of this question Assess the grade and type of each storage unit bull Pharmaceutical grade units may be stand-alone or combination units that are often metal may have glass in the door for viewing inside often have an external digital temperature display and are manufactured by medical companies
bull Commercial or household units often look like your kitchen appliance have vegetablemeat drawers in the unit and are manufactured by household appliance companies
bull Occasionally you might find a medical grade unit which is usually a commercialhousehold unit with a lock and 3-prong plug These are still considered household units because of their ability to maintain proper temperatures and air flow Studies show that household stand-alone units are better able to maintain consistent temperatures than their combination counterparts Combination household units used to store vaccine in both sections of the unit is no longer recommended and may be prohibited in the future Combination household storage units that are having difficulty maintaining a cold enough freezer temperature and a warm enough refrigerator temperature should be replaced or a separate stand-alone freezer should be purchased
For frozen vaccines the most cost effective solution is for the site to purchase a small stand-alone freezer The site may need time to budget for a stand-alone storage unit
Resources bull Replacing Combination Household Units Tip Sheet on IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml)
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The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 434 Storage amp Handling Per Unit Temperature Monitoring Device in the Unit
Question 43 Determine whether there is a temperature monitoring device in this section of the storage unit andanswer the questions
A Is there a temperature monitoring device in this section of thestorage unit
Yes No [X] (If no skip to question 47)
B Who is responsible for supplying the temperature monitoring device in this section of the storage unit Provider
Review CDC Requirement
Certificates of calibration testing provide confidence that the temperature monitoring device is measuring temperaturesaccurately All units storing VFC vaccines must have a calibrated temperature monitoring device with a current and valid certificateof calibration testing All certificates must contain modeldevice name or number serial number date of calibration testing (report or issue date) and Instrument Passed testingInstrument in Tolerance (Recommended uncertainty = +-05ordm C (+-1ordm F))
Goal of this question Assess whether there is a temperature monitoring device in the unit If the unit is not being monitored at all call MDH at 651-201-5522 for guidance
Helpful information bull This question does not ask whether the temperature monitoring device is working or the characteristics of the device These issues will be addressed later in the questionnaire
bull For part B the provider is always responsible for supplying the temperature monitoring device Even if their thermometer or data logger was originally from MDH it is their responsibility to ensure it is functional and calibrated
Resources bull Section 8 in the MnVFC Policies and Procedures Manual
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The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 444 Storage amp Handling Per Unit CDC Recommended Temperature Monitoring Device
Question 44 Assess the temperature monitoring device in this section of the storage unit to answer the questionsbelow
A Is the temperature monitoring device a continuous monitoring and recordingdevice (eg data logger)
Yes No [O] (Skip D)
B Does the temperature monitoring device have a probe in buffered material Yes No [O]
C Does the temperature monitoring device have a digital display that can beeasily read from the outside of this unit
Yes No [O]
D Is data downloaded and reviewed routinely Yes No [O]
Review CDC Recommendation
As of Jan 1 2018 all VFC providers must use continuous temperature monitoring devices (eg data loggers) to monitor vaccinesthat will be administered to VFC-eligible children Routine review and accessibility of temperature data is critical for determining whether vaccine has been properly stored and for assessing usability of vaccine that was involved in a temperature excursion Tomeet VFC Program requirements the device must also be equipped with bull A temperature probe bull An active temperature display that can be easily read from the outside of the unit bull The capacity for continuous monitoring and recording capabilities where the data can be routinely downloaded
The following are additional recommended features for these devices bull Alarm for out-of-range temperatures bull Current minimum and maximum temperatures display bull Low battery indicator bull Accuracy of +- 1degF (05degC) bull Memory storage of at least 4000 readings bull User programmable logging interval (or reading rate) recommended at a maximum time interval of every 30 minutes bull Use of a probe that best reflects the temperature of the vaccine (such as a buffered probe)
Goal of this question Assess the temperature monitoring device in the storage unit Note that these are all recommendations not requirements at this time
This is a great teaching opportunity for sites who do not currently have a continuous temperature monitoring device Beginning Jan 1 2018 all units that store MnVFC vaccine will be required to have a continuous temperature monitoring device (ie a data logger or a continuous temperature monitoring system) Unlike a minmax thermometer a continuous temperature monitoring device provides detailed information on all temperatures recorded at pre-set intervals For excursions it can provide information on when a temperature went out-of-range for how long and what the temperatures were This is essential information that vaccine manufacturers need to know to assess the viability of the vaccine following an excursion
Helpful information bull Sites are required to monitor and record temperatures twice daily however temperature excursions can easily occur in the 12 hours or longer between readings Continuous temperature monitoring can help manufacturers determine vaccine viability
bull Continue to encourage sites to document and evaluate minimum and maximum temperatures the storage unit reached since the last reading and respond appropriately to out-of-range temperatures
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The 2017 MnVFC Site Visit Paperwork Chapter 4
bull It is recommended that sites download and review data weekly Discuss with sites that reviewing temperature monitoring device data also includes responding appropriately if they identify out-of-range temps
bull There is sometimes confusion about the difference between a data logger and a continuous temperature monitoring system Here are some differences
Data Loggers Continuous Monitoring Systems Have an external display similar to thermometers May or may not have an external display Have a detachable probe Probe is usually attached to transmitter Need to be plugged into the computer or cradle to download information on a regular schedule
Wirelessly sends data to computer system
Create a file of data that needs to be saved on the computer
Data is stored within the system not a separate file
Doesnrsquot allow documentation of twice a day temperature checks in the file
May allow documentation of twice a day temperature checks within the system
More about the 2018 requirement for a continuous temperature monitoring device
Required Features bull The continuous temperature monitoring device must have Continuous monitoring and recording capabilities to track and record temperatures over time The capacity to routinely download temperature data to a computer (recommended at least weekly) or wirelessly transmit data Detachable probe in a bottle filled with a thermal buffer (eg bio-safe glycol) if the data logger needs to be detached in order to download data Active temperature display
Recommended Features bull MnVFC recommends continuous temperature monitoring devices with Alarm for out-of-range temperatures Accuracy within +-1degF (+- 05degC) Low battery indicator Display of current minimum and maximum temperatures Memory storage of at least 4000 readings User programmable logging intervals (eg the user can set how often the device records the temperature)
Note that these are all currently recommendations not requirements yet
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
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The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 45
Goal of this question Ensure the temperature monitoring device is properly calibrated The certificate of calibration testing means that the device has been tested and it is accurately measuring temperatures within established testing limits The certificate of calibration ensures that the device meets all the required components
Helpful information bull The provider is always responsible for having a current certificate of calibration (or copy) on-site
bull To be considered ldquovalidrdquo a certificate of calibration must contain these required elements Modeldevice name or number Serial number
4 Storage amp Handling Per Unit Certificate of Calibration Testing
Review CDC Requirement
Certificates of calibration testing provide confidence that the temperature monitoring device is measuring temperaturesaccurately All units storing VFC vaccines must have a calibrated temperature monitoring device with a current and valid certificateof calibration testing All certificates must contain modeldevice name or number serial number date of calibration testing (report or issue date) and Instrument Passed testingInstrument in Tolerance (Recommended uncertainty = +-05ordm C (+-1ordm F))
Question 45
Note to Reviewer
A
B
C
D
E
Review the certificate of calibration testing for the temperature monitoring device in this section of the storage unit and answer the questions below
bull How to determine certificate of calibration testing expiration date 1) Identify the certificate issuecalibration date 2) Apply the Immunization Program-required frequency for calibration testing Example If the
issuecalibration date is 12312013 and Immunization Program policy requires testing every twoyears the expiration date is 12312015
bull Certificates must include all of the below bull ModelDevice Name or Number bull Serial Number bull Date of Calibration Testing (Report or Issue Date) bull Instrument Passed testing (Instrument in Tolerance)
Is there a certificate of calibration testing for the temperature monitoring Yes device in this section of the storage unit No [X]
What is the date of calibration for the temperature monitoring device in this section of the storage unit
What is the certificatersquos date of expiration based on ImmunizationProgram policy (See note to reviewer to determine expiration date) [X] Follow-up is required if
certificate is expired
Does the certificate contain all the necessary items listed in the Note to Yes Reviewer No [X]
Who is responsible for supplying the current and valid certificate of Provider calibration for this temperature monitoring device
Date of calibration testing (report or issue date) Note If there is no expiration date the certificate expires 2 years from the date of calibration Whether the instrument passed or failed testing (or instrument in tolerancenot in tolerance)
bull Recommended element Documented uncertainty of +- 1degF [05degC]
If these elements are present the certificate is considered valid If the certificate contains information about the recommended element or the entity that issued the certificate that is helpful but not required
To determine if a certificate of calibration testing was issued by an appropriate entity check to see if the certificate indicates one or more of these items (this is the wording used to help sites evaluate if their calibration is accurate but is not required on the certificate itself to be considered valid)
bull Conforms to ISO 17025 bull Performed by an ILACMRA Signatory body accredited laboratory You can review this list of the ILAC MRA and Signatories (httpilacorgilac-mra-and-signatories)
bull Traceable to the standards maintained by NIST bull Meets specifications and testing requirements for the American Society for Testing and Materials (ASTM) Standard E2877 tolerance Class F (le 05 degC) or better
bull Includes reference to another acceptable accuracy validation method such as comparison to other traceable reference standards or tests at thermometric fixed points
Note CDC recommends that certifications be issued for the entire monitoring unit (detachable probe data logger etc) and not individual certificates for each component
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The 2017 MnVFC Site Visit Paperwork Chapter 4
For 45 E the provider is always responsible for supplying the current and valid certificate of calibration for a temperature monitoring device
bull Tip If the temperature monitoring device has a sticker on the back with the calibration date the site can usually call the company who calibrated the device and get a copy of the certificate if they donrsquot have one
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 46 4 Storage amp Handling Per Unit Probe Placement
Question 46 Is the probe properly placed in this section of the storage unit
Note to Reviewer ldquoProperlyrdquo means that the probe in a commercial or household unit is placed in a central area of the unitdirectly with the vaccines Probes should not be placed in the doors near or against the walls close to vents or on the floor of the unit The only allowable exemption related to this requirement is for providerswho have pharmaceutical storage units (built for vaccine storage) that have either (1) a built-intemperature monitoring device OR (2) a dedicated port for the probe that dictates the placement of theprobe
Answers (Choose one)
Yes No [X]
Review CDC Requirement
The probe must be placed in a central area of the section of the storage unit directly with the vaccines in order to properly measurevaccine temperature The probe should not be placed in the door near or against the walls close to vents or on the floor of theunit For pharmaceutical units with a built-in temperature monitoring device or a dedicated port for a probe that is not in thecenter of the section of the storage unit consult your Immunization Program for guidance on placement
Goal of this question Make sure the temperature monitoring device is in the best location to accurately measure the temperature of the vaccines stored in the unit
Helpful information bull The probe of the temperature monitoring device should be placed directly with the vaccines in the middle of the unit The ONLY allowable exception is for pharmaceutical storage units that have either a built-in thermometer or a dedicated port for the probe that indicates placement of the probe
bull Temperatures can vary within the unit especially household units bull Call MDH at 651-201-5522 if you have questions
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Guide (wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml)
Page 38 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 474 Storage amp Handling Per Unit Temperature Documentation
Question 47 Review the temperature documentation over the past three months for this section of the storage unit todetermine whether the provider has a process in place for properly documenting temperatures twice aday Answer the questions below
A Are there two temperature readings recorded for this section of the storage unit per day
Yes No [X]
B Is there a time date and name (or initials) recorded for each reading Yes No [X]
C What is the current temperature and minmax temperatures (if available) inthis section of the storage unit Use the reviewerrsquos thermometer if the providerrsquos temperature monitoringdevice does not have a current valid certificate of calibration testing or the probe is not properly placed in this section of the storage unit
Current Temperature Minimum Temperature Maximum Temperature Fahrenheit Celsius
D Based on your review of the providerrsquos recent temperature documentationincluding the current temperature is this section of the storage unitmaintaining appropriate temperatures
Yes No [X] Not enough information [X]
Review CDC Requirement
Vaccines must be stored under appropriate temperatures as described in the package inserts at all times Acceptable temperature ranges vary by vaccine type and the range is 36deg F and 46deg F (2deg C and 8deg C) and for frozen vaccines the range is -58deg F and +5deg F (shy50deg C and -15deg C) Exposure to temperatures outside of those included in the package inserts could affect vaccine viability andultimately could leave children unprotected against vaccine-preventable diseases In order to maintain awareness of storage unittemperatures and ensure that vaccines are being stored at appropriate temperatures at all times VFC providers are required to monitor and document temperatures for all vaccine storage units at least twice a day Temperature documentation must contain (1) at least two temperature readings per day (2) the time and date of each reading and (3) the name (or initials) of the personwho assessed and recorded the readings CDC also recommends that VFC providers record the minimum and maximumtemperatures of each unit once each workday (preferably in the morning)
Goal of this question Ensure the temperature is being monitored twice daily is within the required range and documented correctly Use your thermometer to check the temperature if the sitersquos temperature monitoring devicersquos probe is not properly placed or there is not a current certificate of calibration Place your thermometer in the unit at the beginning of the visit to allow sufficient time to reach an accurate temperature The purpose of using your thermometer is to ensure the vaccine is being stored at the proper temperature not to ldquovalidaterdquo their reading
Question 47 D is an assessment question based on information you have learned during your visit You might answer ldquonot enough informationrdquo if the unit is new and they donrsquot have at least three months of data or if the unit is only used as overflow and they are inconsistent with temperature monitoring Mark ldquoNordquo if you have reason to believe the storage unit is not maintaining temperatures properly
Helpful information bull All sites must document temperatures twice a day every day the site is open even if they have a data logger or continuous monitoring system
bull Sites can document the information electronically with some continuous monitoring systems as long as it can show what the current temp is the date time and initials of the person checking ndash this needs to be someone at the site ndash not checking remotely or centrally for a large site or system The site must be able to produce these records during their site visit Reviewing these files can be a challenge due to large volumes and lots of paper
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Temperature Logs on Managing Vaccine (wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml)
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The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 484 Storage amp Handling Per Unit Temperature Excursions
Question 48 In the event that a temperature excursion(s) occurred in this unit within the last three months requestand review documentation of actions taken to determine whether the provider has a process for properlyaddressing excursions Answer the questions below
A Were vaccines in this unit exposed to out-of-range temperatures in the lastthree months (including today)
Yes No (If no skip to question 49)
B Did the provider quarantine and label vaccines as ldquoDo not userdquo Yes No [X]
C Did the provider place vaccine in a unit where it can be stored under properconditions if applicable
Yes No [X]
D Did the provider contact the Immunization Program to report theexcursion
Yes No [X]
E Was the manufacturer contacted for documentation supporting theusability of the vaccine
Yes No [X]
Review CDC Requirement
The provider must document all excursions and actions taken including the following (1) Quarantine and label vaccines as ldquoDO NOTUSErdquo (2) Place vaccines in a unit where they can be stored under proper conditions (3) Contact the Immunization Program to report an excursion and (4) Contact the vaccine manufacturer to obtain documentation supporting the usability of the vaccine
Goal of this question Address any out-of-range temperatures (temperature excursions) identified in reviewing the last three months of temperature logs or during the site visit If there were any out-of-range temperatures did the site respond appropriately to the situation This is a great opportunity to discuss what to do in the event of an excursion The Clinicians Storage and Handling Mishap Checklist is in the IPI Site Visit information folder and is a good review of the process
Helpful information bull Sites need to know that an excursion does not automatically mean that exposed vaccines are non-viable or unusable Exposed vaccines must be quarantined (marked ldquoDo Not Userdquo) and stored under proper conditions until they have received information from vaccine manufacturers regarding the viability of the vaccine
bull Sites must inform MDH when an excursion occurs
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Clinicians Storage and Handling Mishap Checklist (wwwhealthstatemnusdivsidepcimmunize ipivaxchklstpdf)
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Question 49
Goal of this question Ensure proper placement of vaccines in the storage unit
Note These are all recommendations (best practices) not requirements
Helpful information bull Store vaccine in the middle of the compartment two to three inches away from the coils walls floor and cold air vent The temperature near the floor and walls of the unit differs from that in the middle of the compartment and the cold air vent can freeze refrigerated vaccines
4 Storage amp Handling Per Unit Vaccine Placement
Question 49 Look inside the unit to answer the questions below
A Are vaccines placed in the middle of the unit with space between vaccinesand the sideback of the unit to allow cold air to circulate
Yes No [O]
B Are vaccines stored in their original packages Yes No [O]
C Are there water bottles (for refrigerators) or frozen water bottles (forfreezers) in the unit
Yes No [O]
D Are vaccines store in the doors vegetable bins under or near cooling ventsor on the floor of the unit
Yes [O] No
E Is food being stored in the unit Yes [O] No
Review CDC Recommendation
Vaccines should be stored in their original manufacturer (or CDC centralized distributor) packaging They should be placed in the middle of the unit with space between the vaccines and the sideback of the unit to allow cold air to circulate Vaccines SHOULD NOT be stored in the doors vegetable bins or floor of the unit or under or near cooling vents and there should not be any food inthe unit Water bottles (for refrigerators) or frozen water bottles (for freezers) should be placed throughout each storage unit inorder to (1) stabilize or extend temperatures during a power outage and (2) to serve as physical blocks preventing the placementof vaccines in areas of the unit that are at higher risk for temperature excursions (such as in doors vegetable bins floor ornearunder cooling vents)
bull Vaccines should be kept in their original packaging to Protect them from light Help prevent medication errors by making labels easier to read Provide a moisture barrier that serves as insulation in case of an out-of-range temperature power outage door left open or mechanical failure Simplify managing vaccine inventory
bull Store water bottles in the doors on the floor and near the cold air vent in the refrigerator and frozen water bottles in the freezer to help maintain a stable temperature if there is a power failure and when the door is opened frequently Too many water bottles in the door can prevent the door from closing tightly Mark water bottles ldquoDo Not Drinkrdquo
bull Do not store vaccine in the door or drawers of the refrigerator or freezer Vegetable bins and crisper drawers should be removed from refrigerators or used to store other medical supplies or water bottles
bull If vaccine is stored in a household combination refrigeratorfreezer The top shelf should not be used for storing vaccine because the cold air vent blowing from the freezer will freeze vaccine located there If you must use the top shelf of this type of unit place water bottles underneath the cold air vent to prevent vaccine from being stored there It is recommended that only the refrigerator be used for vaccine storage and a separate stand-alone freezer be used to store frozen vaccine
bull Must not store food or beverages in the refrigerator or freezer because frequent opening of doors can lead to temperature variations that may affect vaccine viability There is also a risk of contaminating vaccines
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Guide (wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml) bull Vaccine Storage Tip Sheet on IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml)
IPI Advisor Manual | February 2017 Page 41
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 4104 Storage amp Handling Per Unit Disconnection from Power Source
Question 410 Ask the provider to demonstrate what measures are taken to ensure that vaccine storage units are notaccidentally physically disconnected from the power supply Which of the following describes the measure(s) taken on this unit
Note to Reviewer bull Large hospitals and healthcare systems may not have the ability to demonstrate labels on plugs or circuitbreakers In such cases verify that the practice has a comprehensive policy and standard operatingprocedures in place to prevent the vaccine storage unit from being physically disconnected from thepower supply
bull While back-up generators may ensure power to the overall facility this question ONLY addresses thevaccine storage unit being accidentally disconnected from the power source either through the plug orthe circuit breaker
Answers A ldquoDo not disconnectrdquo labels on the plug (Choose all that B ldquoWarningrdquo label on the circuit breaker box
apply) C Hard-wired (ie built-in) and has a ldquoDo not disconnectrdquo label on thecircuit breaker box D Hospital or large health care system with a comprehensive written policyand standard operating procedures detailing measures taken to preventvaccine storage units from being accidentally disconnected from the powersupply E No acceptable measures for preventing accidental disconnection frompower supply [X]
[X] The response is non-compliant if only A only B or E is selected
Review CDC Requirement
VFC providers must take steps to protect the power source for all vaccine storage equipment by means of having clear warninglabels on both the plug and the circuit breaker associated with all vaccine storage units Large hospitals and healthcare systems canmeet this requirement by demonstrating that they have comprehensive policies and standard operating procedures to preventvaccine storage units from being physically disconnected from the power supply
Goal of this question Decrease the chance that a vaccine storage unit will be accidently unplugged or power will be turned off while vaccine is in the unit This question addresses only what measures the site has taken to ensure the storage unit is not physically disconnected from its power source
If the site uses labels on the plugs and circuit breakers perform a visual inspection to assess whether the way the stickers are positioned make it clear and obvious to anyone that these units are not to be disconnected
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Do Not Unplug and Warning stickers are included in the folder or available to order on the For
Professionals Order Form (wwwhealthstatemnusdivsidepcimmunizeordermathtml)
Note Once you have completed the 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet for each unit return to the questionnaire to complete sections 5 and 6
Page 42 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
- -
Section 5 Storage amp Handling Site-Wide Question 51
5 Storage amp Handling Site Wide Discussion of Cost amp Quantity of Vaccine
Question 51 Have a discussion with the provider about the cost and quantity of VFC vaccines they are responsible for annually Address the points listed in the note to reviewer below
Note to Reviewer bull Vaccine Shipped (Required) Share the cost of VFC vaccines shipped to the provider in the last calendaryear to make sure the provider understands the contribution made by the VFC Program to their practiceFor new providers who do not have ldquocalendar yearrdquo data share either the actual cost of their currentinventory or use the cost of 10 VFC doses of each of the ACIP-recommended vaccines (approximately $7000) to help estimate their annual cost
bull Storage amp Handling (Required) Make sure the provider understands the cost of vaccines for which they are responsible when they make decisions about purchasing recommended vaccine storage and temperature monitoring equipment
Answer I have discussed with the provider the cost and quantity of vaccines ordered in the previous calendar year
Goal of this question Inform sites of the quantity and value of vaccines that they receive as part of the MnVFC program Providers often donrsquot realize the value of the vaccine in their unit This information is included on your clinic list and on the one page site-specific information
Helpful information bull This discussion must occur and the box on the questionnaire must be checked bull If there isnrsquot actual vaccine value information available tell the site that one vaccine order that includes a box of each of the ACIP recommended vaccines costs approximately $7000
bull MDH may not have specific information for individual sites if they receive vaccine from a central warehouse or pharmacy For those sites MDH will give you numbers for the whole system so you can discuss system wide data as appropriate If individual site information is also included it is usually just varicella-containing vaccines that must be shipped directly to the site
Question 52
5 Storage amp Handling Site Wide Dorm Style Units
Question 52 Determine whether the provider has any dorm-style units on site and answer the questions below
Note to Reviewer A dormitory-style refrigerator is a unit that has both refrigerator and freezer compartments behind a singleexterior door Dorm-style units also have an evaporator plate (cooling coil) which is usually located insidean icemaker compartment (freezer) within the refrigerator
A Does the provider have any dorm-style units that are used at any time tostore vaccines
Yes [X] No (Skip to question 53)
B Does the provider have sufficient space in existing compliant vaccinestorage units to store all vaccines without use of the dorm-style unit at any time
Yes No [X]
Review CDC Requirement
Dorm- and bar-style units are prohibited for vaccine storage Vaccines stored in dorm-style units are considered non-viable and must be returned to the centralized distributor CDC recommends the following vaccine storage unit types (in order of preference)pharmaceutical grade stand-alone or combination units (preferred) householdcommercial stand-alone unitshouseholdcommercial combination units using the refrigerator section only
Goal of this question Ensure no vaccine is stored in dorm-style units even for short periods of time Encourage them to label any units ldquoNo Vaccine Storage Allowedrdquo Vaccine stored in these units is considered non-viable If a site is using a dorm-style unit call the MnVFC program (651-201-5522)
Resource Section 8 in the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 43
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 535 Storage amp Handling Site Wide Storage Unit Space Availability
Question 53 Does the provider have sufficient room across storage units to store current stock as well as anyadditional stock acquired during peak season without overcrowding
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have sufficient storage space to accommodate vaccine stock at the busiest time of year without overcrowding
Goal of this question Ensure that sites have sufficient space in their units to maintain vaccines at the busiest time of year Overcrowding of vaccine limits air circulation and affects the unitrsquos ability to maintain stable temperatures
Helpful information bull Look for signs of overcrowding such as vaccines that are pushed up against the wall bins that are overflowing or storage units that are full during non-peak seasons
Discuss immediate actions if the unit is overcrowded Move some of their vaccines order less vaccine more frequently (once per month preferably) andor purchase another storage unit for overflow
Resource bull Section 8 MnVFC Policy and Procedure Manual
Page 44 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 545 Storage amp Handling Site Wide Expired Vaccines
Question 54 Look in each unit Are there expired vaccines in any of the vaccine storage units at this site
Answers (Choose one)
Yes [X] No
Review CDC Requirement
Vaccines should be rotated weekly and when a new shipment comes in so that longer-dated vaccines are stored behind shorter-dated vaccines If vaccines expire they can no longer be stored in the same storage unit with viable vaccines They must be placedin a container or bag clearly labeled ldquoDo not userdquo and separated from viable vaccines to prevent inadvertent use Expired vaccinemust be returned to the centralized distributor within six months of expiration
Goal of this question Ensure there is no expired vaccine in any storage unit
Helpful information bull Sites can prevent their stock from expiring by rotating vaccines every week andor when a new shipment arrives Longer-dated vaccines are stored towards the back of the unit and shorter-dated vaccines are up front
bull Pay attention to vaccines that expire within the next three months Consider transferring vaccine that will expire soon to another MnVFC-enrolled site that will use the vaccine preferably a site close by It is the transferring sitersquos responsibility to arrange the transfer of the vaccine Be sure to complete the MDH Vaccine Transfer Record form and send it to MDH If they are having difficulty finding a location to accept vaccine contact MDH
bull This is a great opportunity to educate sites about the MDH Nonviable Vaccine Form and the process for returning vaccine The VFC program does get some credit for taxes and fees on vaccine that is returned to the distribution center
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MDH Nonviable Vaccine Form and MDH Vaccine Transfer Record on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfcformshtml)
IPI Advisor Manual | February 2017 Page 45
The 2017 MnVFC Site Visit Paperwork Chapter 4
- -
-
Question 555 Storage amp Handling Site Wide Back up Thermometer
Question 55 Does the provider have a readily available back-up thermometer with a current and valid certificate ofcalibration testing
Note to Reviewer ldquoReadily availablerdquo means that the thermometer is available to perform twice-a-day monitoring for a unit asrequired CDC recommends that the back-up thermometer be maintained on site
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have a readily available back-up thermometer with a current and valid certificate of calibration testing Toprevent the certificates of calibration testing of the primary and back-up thermometers from expiring at the same time the date of calibration testing (or issue date) of the back-up thermometer should be different from the date of calibration testing (or issue date) of the primary thermometer As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meetsVFC program requirements
Goal of this question Ensure sites have one calibrated back-up thermometer onsite that is readily available in the event that the temperature monitoring device in unit fails transportation of vaccine is needed or there are other unexpected circumstances
Helpful information bull As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meets VFC Program requirements
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 56 5 Storage amp Handling Site Wide Preparation of Vaccine
Question 56 When does this provider prepare vaccine for administration to the patient
Note to Reviewer For mass vaccination clinics if one type of vaccine is offered providers may pre-draw up to 10 doses Ifusing pre-filled syringes pre-drawing also means activating the syringe by removing the needle guard orattaching a needle
Answers (Choose all that
apply)
Prepare dose immediately before administration Pre-draw doses for upcoming patients (in a regular clinicpractice) [O] Pre-draw up to 10 doses (in a mass-vaccination clinic) Pre-draw more than 10 doses (in a mass-vaccination clinic) [O] Other [O]
Review CDC Recommendation
CDC recommends preparing vaccines immediately prior to administration in order to assure viability of vaccine and prevent vaccinewastage Vaccines that are not administered immediately are at risk of exposure to temperatures outside of the required rangewhich can affect vaccine viability and ultimately can leave children unprotected against vaccine-preventable diseases
Goal of this question Discuss proper timing and preparation of vaccine(s) for administration These are recommendations not requirements
Helpful information bull Educate staff on the importance of preparing vaccine immediately before administration Pre-drawing of vaccines may lead to concerns related to vaccine viability potency sterility and wastage
Page 46 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 6 Inventory Question 61
6 Inventory Inventory Comparison
Question 61 Visually inspect storage units to determine if existing supply of vaccines proportionately mirrorspopulations served Choose the most accurate statement below
Note to Reviewer bull CDC recommends that providers maintain a four-week supply of inventory bull For this question do not take into account vaccine types that the provider does not order Here simply
make sure that overall the vaccines in the providerrsquos storage units are available in sufficient amounts toserve their patient population
Answers (Choose one)
The current vaccine inventory proportionately reflects the populations identified Only public stock is insufficient [X] Only private stock is insufficient [X] Both public and private stock are insufficient [X] Site uses the replacement method but does not appear to have enough vaccine for their population [X] Other [X]
Review CDC Requirement
VFC providers must order and stock routine vaccines in accordance with their patient population in order to prevent missedvaccination opportunities Having sufficient amounts of all stocks prevents the inadvertent use of VFC vaccines for non-VFC-eligiblepatients and vice versa
Goal of this question Assess whether the site is ordering appropriate quantities of vaccine for the population they serve at their site
Helpful information bull If the site sees 30 percent private-pay patients and 70 percent VFC the stock in their storage units should reflect that proportion If you donrsquot know you can ask the site about their population
bull This is meant to be a general assessment so in a big site if they have only a small amount of vaccine that may indicate an issue with vaccine management
bull CDC recommends smaller more frequent orders (ie monthly) rather than large orders to minimize the amount of vaccine loss if an incident occurs during shipment or in the storage unit Sites should not order more frequently than once a month
bull Sites using the replacement method will only have one stock but it should appear to be large enough for their population
bull Only assess the vaccine types that the site currently stocks in their unit We know there are sites that do not offer all ACIP-recommended vaccines for various reasons That issue will be addressed in question 62
IPI Advisor Manual | February 2017 Page 47
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 626 Inventory ACIP Recommended Vaccines
Question 62 Review providerrsquos current inventory to answer the questions below
A Does the provider offer all routine ACIP-recommendedvaccines for their patient population
Yes (Skip to question C) No [X] Offers all except varicella because direct ship ofvaccine is unavailable from manufacturer
B Which routine vaccines are NOT being offered DTaP Hepatitis A Hepatitis B HIB HPV Influenza Meningococcal
MMR Pneumococcal Polio Rotavirus TdapTd Varicella
C According to Immunization Program Policy does theprovider make accessible all non-routine ACIP-recommended vaccines for those VFC patients whomeet the criteria for receiving them
Yes (Skip to question 63) No [X]
D Which non-routine vaccines are NOT being offered Pneumococcal polysaccharide vaccine (PPSV23) Meningococcal Group B (MenB) Other
Review CDC Requirement
VFC providers agree to comply with immunization schedules dosages and contraindications that are established by the Advisory Committee on Immunization Practices (ACIP) for the vaccines identified and agreed upon in the Provider Agreement UNLESS bull In the VFC providers medical judgment and in accordance with accepted medical practice the VFC provider deems such
compliance to be medically inappropriate for the child bull The particular requirements contradict state law including laws pertaining to religious and other exemptions The VFC program entitles children to the following vaccines DTaP Hepatitis A Hepatitis B HIB HPV Influenza MeningococcalMMR Pneumococcal Polio Rotavirus TdapTd and Varicella VFC providers are also required to ensure that VFC-eligible children have access to non-routine vaccines as needed
Goal of this question Assess if the site is offering all the ACIP-recommended vaccines for the population they serve and these vaccines are in stock on the day of the visit It is important that every MnVFC-eligible child that comes to a providerrsquos office for an immunization is vaccinated
Helpful information bull The Advisory Committee on Immunization Practices (ACIP) is a group of medical and public health experts that develops recommendations on how to use vaccines to control diseases in the United States
bull Specialty providers are not required to offer all routine vaccines but should provide the vaccines appropriate for their population
bull If the site does not offer all routine ACIP-recommended vaccines appropriate for their population check the ldquoNordquo box in Part A then check the appropriate box(es) in Part B for any vaccines not offered Please contact MDH as this situation offers us the opportunity to provide education to the site
bull For non-routine vaccines they must either be in stock or the site must have an alternative protocol in the routine management plan that ensures these children have access when applicable
Resources bull IAC Diseases and Vaccines (wwwimmunizeorgvaccines) bull CDC Advisory Committee on Immunization Practices (ACIP) (wwwcdcgovvaccinesacipindexhtml)
Page 48 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 636 Inventory Separation of Stock
Question 63 Observe how the provider differentiates stock in each storage unit to answer the questions below
A Is it clear which vaccines belong to public stock andwhich belong to private stock
Yes No [X] Not applicable replacement site
B Is it clear which vaccines belong to VFC stock andwhich belong to UUAV stock
Yes No [X] Not applicable replacement site Not applicable not UUAV-enrolled site
Review CDC Requirement
In order to ensure that VFC vaccines are only administered to VFC-eligible children VFC providers that serve both VFC and non-VFCshyeligible children must maintain their vaccine inventories in such a way that they can clearly differentiate public stock from privatestock as well as VFC from other public stock
Goal of this question Assess whether the site can distinguish between MnVFC vaccine and private vaccine If they participate in the Uninsured and Underinsured Adult Vaccine (UUAV) program they should also be able to distinguish between MnVFC stock and UUAV stock Some sites use labels bins boxes etc to differentiate their stock If it is not clear how the site differentiates their stock discuss vaccine management with the staff For follow-up call MDH to discuss doing a follow-up site visit
Sites using the replacement method will not have separate stocksmdashthis is an approved alternative method for keeping track of vaccine
Resource bull Section 10 of the MnVFC Policy and Procedure Manual
IPI Advisor Manual | February 2017 Page 49
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
MnVFC Site Visit Storage and Handling Per Unit Answer Sheet 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet MnVFC PIN ___________________
Question number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
Temperature Monitoring Device Questions Questions 43 47 must be answered separately for the freezer and refrigerator if the unit is a combo Be sure to document responses in the appropriate column
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
All the questions on the Site Visit Storage amp Handling Per Unit Answer Sheet have been discussed previously in section 4 of this manual Use this sheet to record information about all the units at the site visit You will need one sheet for each unit If it is a combination unit (either pharmaceutical or household) you can record both sections on one sheet If they have stand-alone units use one sheet for each unit Do not enter the answers to the questions in section 4 of the questionnaire
If you need more information about any of the questions refer back to the main questionnairemdashthe complete question additional guidance including notes to the reviewer and the CDC requirements are there Also if the site is not meeting the requirement you will go back to the questionnaire to complete the ldquoActions if Non-compliantrdquo section including the root cause analysis and follow-up sections
When you have completed the assessment of all the storage units remember to go back to the questionnaire to complete sections 5 and 6
Page 50 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
ndash
ndash
MnVFC Provider Follow-up PlanThe goal of the Provider Follow-up Plan is to communicate with the site all of the VFC requirements any unmet requirements found during your site visit and the timeline for completing the required action The left hand column is a box to check for ldquoUnmetrdquo requirements
Helpful information bull The form can be used to review what the site is doing well and what they need to work on
bull For requirements that have specific documentation that needs to be sent to you use the notes section
2017 MnVFC Provider Follow-up Plan Site _______________________________________________ MnVFC PIN ____________ Date of Visit ___________
Thank you for participating in this MnVFC compliance site visit Please review this visit summary including follow-up actions and timelines for completion Unmet MnVFC requirements and recommendations have a checked box next to them The goal of this plan is to support you with successfully implementing the program and improving access to vaccines for VFC-eligible children
Unmet Question VFC Requirements Section 1 Changes to Key Staff
Q12 Change in the Medical Director Immunization Manager Vaccine Coordinator or back-upKey Staff must be communicated to the immunization program by emailing healthmnvfcstatemnus Changes Notes
Q12 Key staff must complete the annual training on VFC program requirements and print theAnnual Training certificate of completion Documentation Required Action
Staff that have not completed the MnVFC online training must complete it and send acopy of the certificate to the reviewer Training can be found on the MnVFC website (wwwhealthstatemnusvfc) Due date 1 month
Notes
Unmet Question VFC Requirements Section 2 Eligibility
Q21 Provider staff must possess a working knowledge of all VFC eligibility criteria and use thoseVFC Eligibility criteria to screen children prior to administering VFC vaccines
Categories Notes
bull This form provides documentation needed for follow-up actions when you send your thank you email
The second to last page of the Provider Follow-up Plan has a summary of the MnVFC program recommendations These are to remind the site about best practices they may want to improve upon even though they are not yet requirements of the program For example you could discuss the recommendation about storage units if they currently have a combination household unit and are using both sections
The last section is for your signature and the person you met with In most sites it will be the immunization manager or vaccine coordinator who signs the form unless the medical director attended the site visit You keep the original copy and the site will need to keep a copy for themselves
To be completed by the site visit reviewer
I acknowledge that a VFC site visit was performed on __________________ (visit date) The follow-up plan which includes a list of all current VFC program requirements and recommendations assessed during the visit and any required follow-up actions was provided at the end of the visit
Site visit reviewer
Phone
Reviewer Signature Date
To be completed by the provider
I acknowledge that our practice took part in the VFC site visit noted above I understand the findings of the visit and any required actions that must be taken by our office in order to meet VFC program requirements
Medical Director (or designee) Name Title
Medical Director (or designee) Signature Date
IPI Advisor Manual | February 2017 Page 51
The 2017 MnVFC Site Visit Paperwork Chapter 4
After the Site Visit Send a thank you email highlighting the unmet requirements documents you need from the site to resolve the issue(s) and the date you need them Make sure to include the link to the Site Visit Survey (httpssurveyvovicicomseashxs=56206EE334CE0B14)
Please refer to Chapter 3 for more information about future follow-up required after the visit including forms and documentation
Resource bull Sample Thank You letter on IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml)
Chapter 5
IPI Advisor Resource List MnVFC Program 651-201-5522
MnVFC wwwhealthstatemnusvfc
bull Separate Stock and Replacement Method Policies and Procedures Manuals bull Online trainings bull MnVFC Announcements sign up to receive them via email bull Ordering MDH vaccine bull MnVFC forms Screening forms Reporting forms Others MDH Nonviable Vaccine Form MDH Vaccine Transfer Record and Vaccine Borrowing Report
bull MnVFC promotional materials bull Immunization Billing Guidance for MnVFC and Immunization Billing Guidance for MnVFC Replacement Sites Immunization Practices Improvement Program (IPI) wwwhealthstatemnusdivsidepcimmunizeipi
bull IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml) bull IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml) IPI Resource Folder Contents (wwwhealthstatemnusdivsidepcimmunizeipiipifolderpdf)
Minnesota Immunization Information Connection (MIIC) wwwhealthstatemnusmiic
bull MIIC regions and regional coordinators
Clinical Practice MDH Immunization Program wwwhealthstatemnusimmunize
Got Your Shots News wwwhealthstatemnusdivsidepcnewslettersgys
MDH Immunization Information for Health Care Providers wwwhealthstatemnusdivsidepcimmunizehcp
bull Got Your Shots A Providers Guide to Immunization in Minnesota bull Vaccine protocols bull Forms for tracking patient immunizations bull Immunization schedules for Health Care Providers Immunization Action Coalition (IAC) wwwimmunizeorg
bull Ask the Experts bull VISs (Vaccine Information Statements and translations) bull Administration screening questions bull Medical management of vaccine reactions bull Order form for Californiarsquos Immunization Technique DVD Best Practices with Infants Children and Adults
Page 52 IPI Advisor Manual| February 2017
IPI Advisor Resource List Chapter 5
CDC ldquoPink Bookrdquo wwwcdcgovvaccinespubspinkbookindexhtml
CDC Advisory Committee on Immunization Practices (ACIP) wwwcdcgovvaccinesacip
CDC Vaccines and Immunizations wwwcdcgovvaccines
VAERS reporting httpvaershhsgovindex
Storage and Handling Got Your Shots Providers Guide ndash Managing Vaccine wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml
MnVFC Guide to Temperature Monitoring Devices wwwhealthstatemnusvfc
MDH Clinicianrsquos Vaccine Mishap Checklist wwwhealthstatemnusdivsidepcimmunizeipivaxchklstpdf
MDH Vaccine Storage Guide wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml
CDC Vaccine Storage and Handling Toolkit wwwcdcgovvaccinesrecsstoragetoolkit
You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Vaccine manufacturer phone numbers wwwcdcgovvaccinespubspinkbookdownloadsappendicesFcontact-info-manufactpdf
IAC Checklist for Safe Vaccine Handling and Storage wwwimmunizeorgcatgdp3035pdf
IAC Donrsquot Be Guilty of These Errors in Vaccine Storage and Handling wwwimmunizeorgcatgdp3036pdf
Additional Resources Print materials from MDH ndash order forms wwwhealthstatemnusdivsidepcimmunizeordermathtml
Vaccine Education Center ndash Childrenrsquos Hospital of Philadelphia wwwchopeduservicevaccine-education-centerhomehtml
California Department of Public Health ndash Interactive training on vaccine administration and storage and handling handout on transporting vaccine and how to package wwwezizorg
IPI Advisor Manual | February 2017 Page 53
IPI Advisor Resource List Chapter 5
CDC vaccine price list wwwcdcgovvaccinesprogramsvfcawardeesvaccine-managementprice-listindexhtml
Vaccine Information Statements (VIS) wwwcdcgovvaccineshcpvisindexhtml
CEU Opportunities CDC Immunization Education and Training wwwcdcgovvaccinesedindexhtml
Immunization You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Page 54 IPI Advisor Manual| February 2017
- Introduction
-
- Welcome to the Immunization Practice Improvement (IPI) Program
- Contact Information
-
- Chapter 1
- Requirements to Participate in the MnVFC Program
- Vaccines for Children Program
- Chapter 2
- Reimbursement for MnVFC Visits
- Types of Visits
- Your MnVFC Clinical CoordinatorPlanner
- New IPI Advisor Training Requirements
- Your Role as an IPI Advisor
- Reasons MDH Would Do All or Part of a Visit
- Chapter 3
- Future follow-up
- Conducting the Visit
- Preparing for the Visit
- Information for the Visit
- Site Visit Checklist
- Scheduling the Visit
- Chapter 4
- After the Site Visit
- MnVFC Provider Follow-up Plan
- MnVFC Site Visit Storage and Handling Per Unit Answer Sheet
- Section 6 Inventory
- Section 5 Storage amp Handling Site-Wide
- Section 4 Storage amp Handling Per Unit
- Section 3 Documentation
- Section 2 Eligibility
- Section 1 Provider Details
- The Site Visit Reviewer Legend
- MnVFC Site Visit Questionnaire
- Required Paperwork for Site Visits
- Chapter 5
-
IPI Advisor Manual | February 2017 Page 27
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 353 Documentation Borrowing Reasons
Question 35 Based on your discussion with the provider and a review of borrowing reports document the dosesborrowed for each reason and answer the questions below
Note to Reviewer bull Short-dated vaccines are doses that are likely to expire before they can be used bull Exchanging short-dated vaccines should only occur in practices that have a small number of private
patients
A Reasons for Borrowing a VFC Dose (Enter the number of _____ Private vaccine shipment delay (order placed on time but delay in shippingreceipt)
vaccine doses borrowed for each
reason in the spaces
_____ Private vaccine not useable on arrival (vials broken temperature monitor out of range) _____ Ran out of private vaccine between orders (provider orders not placed on time) [X]
provided) _____ Short-dated private dose was exchanged with VFC stock _____ Accidental use of VFC dose for a private patient (human error) _____ Replacement of private dose with VFC when insurance plan did not cover vaccine _____ OtherDocumented dose did not include reason for borrowing [X]
(Explanation Required) Reasons for Borrowing a Private Dose _____ VFC vaccine shipment delay (order placed on time but delay in shippingreceipt) _____ VFC vaccine not useable on arrival (vials broken temperature monitor out of range) _____ Ran out of VFC stock between orders (provider orders not placed on time) [X] _____ Short-dated VFC vaccine dose was exchanged with private dose _____ Accidental use of a private dose for a VFC-eligible patient (human error) _____ OtherDocumented dose did not include reason for borrowing [X]
(Explanation Required)
B Enter date range for instances of borrowing reviewed in the borrowing report Note If ldquoDate of earliest instancerdquo is not available use the date of the last VFC Compliance Visit If ldquoDate of last instancerdquo is not available use the date of thecurrent VFC Compliance Visit
Date of earliest instance
Date of last instance
C Does borrowing appear to be a routine practice Note To determine whether borrowing is a routine practice assess frequency of and repeating reasons for borrowing Examples Frequent accidental use of incorrect stock exchanging short-dated vaccines or issues with ordering and shipment
Yes [X] No
Goal of this question Determine the reasons why the site is borrowing vaccine
If sites are using the Vaccine Borrowing Report review the reasons for borrowing to help document borrowed VFC andor private doses If they have not been documenting borrowing on this report (or any other form) estimate their borrowing practices If you do not know the date range for their borrowing use the last site visit date to the current visit date The use of ldquootherrdquo as the reported reason for borrowing should be rare if ever and would require explanation and follow up
Helpful information bull Look to see if they routinely maintain insufficient amounts or types of vaccine to support their public and private patients that leads to borrowing
bull Pay attention to borrowing cases documented as ldquoaccidentalrdquo Repetitive accidental borrowing may indicate an issue with ordering processes or insufficient staff training
bull Borrowing is not a place to document wasted or lost doses bull The time period of the borrowing may give you clues about the root cause Were the borrowed doses concentrated in a short period or spread out across several months or a year Are all vaccine types being borrowed or just one
bull If borrowing seems to be an issue discuss vaccine management ordering procedures
Resources bull Vaccine Borrowing Report on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfc formshtml)
bull Section 10 in the MnVFC Policies and Procedures Manual
Page 28 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 36
3 Documentation Vaccine Management Plan
Question 36 Physically review the providerrsquos Vaccine Management Plan to answer the question below
A Does the provider have a Vaccine Management Plan Yes No [X] (If no skip to question 37)
B Does the plan list the current Immunization Manager Vaccine Coordinator andback-up
Yes No [X]
C Does the plan address proper vaccine storage and handling practices Yes No [X]
D Does the plan specify vaccine receiving procedures Yes No [X]
E Does the plan contain procedures for what to do with vaccine in the event of an emergency
Yes No [X]
F Does the plan contain procedures for vaccine ordering Yes No [X]
G Does the plan address inventory control (example stock rotation) Yes No [X]
H Does the plan address how to handle vaccine wastage Yes No [X]
I Does the plan address staff training and documentation on vaccine managementstorage amp handling
Yes No [X]
J Does the plan contain a review date that falls within the last 12 months Yes No [X]
K Has the plan been signed by the individual responsible for its content Yes No [X]
Review CDC Requirement
VFC providers must develop maintain and implement a Vaccine Management Plan for routine and emergency vaccinemanagement The plan must contain the current Vaccine Coordinator and back-up proper storage and handling practicesshipping and receiving procedures emergency procedures procedures for vaccine ordering inventory control (eg stock rotation)how to handle vaccine wastage and staff trainingdocumentation on vaccine management storage and handling The plan must bereviewedupdated annually or more frequently if changes occur A ldquoreview daterdquo and signature are required on all plans in order tovalidate that they are current
Goal of this question Evaluate the sitersquos plan for vaccine management It is especially important that they have a plan for emergency management of their vaccine in the case of equipment failure or power outage Encourage all sites to read and sign the MnVFC Policies and Procedures Manual and complete the emergency plan or be able to show you a plan of their own
If the provider is not able to physically show you the plan at the time of the visit or if the recorded review date is not within the last 12 months you must mark that this requirement is unmet The Vaccine Management Plan is important in times of emergency and it should be easy to access by any staff member at any time Encourage them to post the plan and put a copy with the packing supplies
Helpful information bull Encourage the site to fill in the ldquoImmunization Managerrdquo and ldquoVaccine Coordinatorrdquo fields in the
MnVFC Policies and Procedures Manual for their own referencebull The emergency plan in the manual can be reviewed from last year and included in this yearrsquos manual (with an updated signature and date) if there have not been any changes
bull If information in the plan is outdated site staff will not be well equipped to safely manage vaccines in the event of a power-outage or other emergency situation
bull If their institutional policy is only reviewed and updated every 3-4 years (as many are) the staff may need to sign the MnVFC Polices and Procedure Manual to meet this requirement
Resource Routine Vaccine Management Plan and Emergency Vaccine Management Plan in the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 29
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 37
3 Documentation VIS amp VAERS
Question 37 Review the providerrsquos Vaccine Information Statements (VISs) and discuss providerrsquos VAERS process toanswer the questions below
A Does the provider have readily available up-to-date VISs for all ACIP-recommendedvaccines relevant to the populations it serves
Yes No [X]
B Does the provider make a VIS available for patientsparents before eachvaccination
Yes No [X]
C Does the provider know how and when to report clinically significant adverseevents using VAERS
Yes No [X]
Review CDC Requirement
VFC providers are required to distribute the current Vaccine Information Statements (VIS) each time a vaccine is administered and maintain records in accordance with the National Childhood Vaccine Injury Act (NCVIA) which includes reporting clinicallysignificant adverse events to the Vaccine Adverse Event Reporting System (VAERS) For a list of current VISs visit CDCrsquos Vaccine Information Statements (httpwwwcdcgovvaccineshcpvis) website
Gal of this question Ensure the site has the most current VISs and is giving them to each patientparent before administering the vaccine in compliance with the federal law Parents must be educated about the vaccine their child will receive and be aware of possible contraindications and side-effects in order to make well-informed decisions about their childrsquos health
Helpful information bull Ask to see the sitersquos VISs to determine if they have an active protocol for giving VISs to parents Review to make sure they are current Ask if they know where and how to report vaccine adverse events
Resources bull Section 3 in the MnVFC Policies and Procedures Manual bull CDC Vaccine Information Statements (wwwcdcgovvaccineshcpvisindexhtml) Site may sign up for email updates for the current list of VIS publication dates for the most up-to-date version
bull IAC Itrsquos Federal Law You must give your patients current Vaccine Information Statements (wwwimmunizeorgcatgdp2027pdf)
bull VAERS (httpsvaershhsgovindex)
Question 38
3 Documentation Anaphylaxis protocol
Question 38 Does the site have an anaphylaxis protocol which is clearly posted near the emergency kit
Answers (Choose one)
Yes No [X]
Review CDC Requirement
An anaphylaxis protocol must be clearly posted in the area where vaccines are administered
Goal of this question Make sure site is prepared for a severe allergic or anaphylactic reaction to a vaccine
Resources bull Section 11 in the MnVFC Policies and Procedures Manual bull IAC protocols Child and Teens (wwwimmunizeorgcatgdp3082apdf) and Adults (wwwimmunize orgcatgdp3082pdf)
Page 30 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
i
i i i - li i i i i i l
Section 4 Storage amp Handling Per Unit The goal of this section is to assess vaccine storage
2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet practices in each unit at the site MnVFC PIN ___________________
The 2017 MnVFC Storage amp Handling Per Unit Answer Sheet is a worksheet to document the answers to the questions in this section for each unit (combination or stand-alone) Fill in the answers to the questions in Section 4 on the answer sheet not in the questionnaire
The answer sheet has an abbreviated form of each question If you need further information on that question refer back to the full questionnaire Also if you find an area where the site is not meeting the requirements you will need to go back to that question on the 2017 MnVFC Site Visit Questionnaire to complete ldquoActions if Non- compliantrdquo section including the root cause analysis and follow-up sections If there is a problem in more than one unit make a note on the questionnaire which unit you are referring to in the Notes section
Important You must fully assess any unit that may be used to store VFC vaccines even if there are no VFC vaccines there on the day of the visit If there are no vaccines and the site is not documenting twice a day temperatures discuss the need to ensure the unit is maintaining stable temperatures by monitoring for one week before placing vaccines in the unit
Quest on number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
for the freezer and e co umn
Temperature Monitoring Dev refr gerator f the un
ce Quest ons Quest ons 4 3 4 7 must be answered separate y t s a combo Be sure to document responses n the appropr at
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
44D Data downloaded and reviewed routinely (eg weekly)
Yes No [O]
Yes No [O]
45A Certificate of Calibration Testing Yes No [X]
Yes No [X]
45B Date of calibration
45C Date certificate expires [X] Follow-up is required if expired [X] Follow-up is required if expired
45D Certificate contains all necessary items
Yes No [X]
Yes No [X]
46 Probe properly placed Yes No [X]
Yes No [X]
47A Two temperature readings per day
Yes No [X]
Yes No [X]
47B Time date and name (or initials) for each reading
Yes No [X]
Yes No [X]
47C Current temperature and minmax temperatures (if
Current ________deg Minimum ________deg Maximum _deg
Current ________deg Minimum ________deg Maximum _deg
Sections 5 and 6 contain questions about storage and handling site wide and inventory It is helpful to keep those questions in mind as you assess the individual storage units Think about dorm-style units expired vaccine vaccine supply room for vaccine stocking all the recommended vaccines and separation of stock if appropriate
NOTE The sections that follow require reviewers to validate responses by looking at vaccine storage units temperaturemonitoring equipment and the vaccine inventory inside a unit bull For section 4 use a separate Storage amp Handling Per Unit Answer Sheet for each unit to document the findings (combination
units using both sections can be documented on the same answer sheet) bull When an unmet requirement is identified return to this questionnaire to complete the ldquoActions if Non-compliantrdquo section for
that question bull After you complete one answer sheet for each unit return to the questionnaire to complete sections 5 and 6 using information
you gathered while assessing the units The questions in sections 5 and 6 (Storage amp Handling Site-Wide and Inventory) are notunit-specific but do require that the response be based on a thorough assessment of all the providersrsquo units
4 Storage amp Handling Per Unit
Description On the Storage amp Handling Per Unit Answer Sheet place a name that will allow you or someone else from your program to easily identify this unit in the event of follow-up We recommend using Brand + Location(example Samsung - Room 123) Save each Storage amp Handling Per Unit Answer Sheet with the Brand + Location in the file name
(example SamsungRoom123doc)
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The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 41
4 Storage amp Handling Per Unit Storage Unit Build amp Use
Question 41 Below select the build and use of the vaccine storage unit you are assessing
Note to Reviewer Dorm-style units Do not add dorm-style units here Dorm-style units will be addressed in section 5 Units storing only private stock You must review these storage units even if they contain only private stockat the time of the visit because that vaccine could be administered to VFC patients
A What type of unit is this A Stand-alone B Combination
B Select use if stand-alone A Freezer B Refrigerator
Select use if combination A Use both sections to store vaccine B Use freezer section only to store vaccine C Use refrigerator section only to store vaccine
Goal of this question Identify the unit you are evaluating The description asks you to create a unique name for this unit so that you will be able to identify the same unit in future site visits Put this description on the top of the answer sheet (ie make and location)
Helpful information bull A stand-alone unit is either a refrigerator or a freezer It does not have both sections in the unit bull If there is a combination unit note if the site uses both the refrigerator and freezer or only one section of the unit to store vaccines CDC does not recommend the use of either section or the freezer section only of combination household units
bull If your site utilizes the separate stock method of vaccine management you must review storage units even if they contain only private stock at the time of the visit because there is a chance that those vaccines could be administered (borrowed) to VFC-eligible patients
Page 32 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 424 Storage amp Handling Per Unit CDC Recommended Storage Units
Question 42 Below document the grade of the vaccine storage unit you are assessing
Note to Reviewer Pharmaceutical Also called ldquopurpose-builtrdquo these units are designed by the manufacturer specifically tostore vaccines or other biological materials Commercial Although usually intended to store food and beverages commercial units are often larger and more powerful than the household units found in most homes Though these units are intended to meet thehigher demands of larger facilities these units are not specifically built for the storage of biologicalmaterials Household (non-commercialdomestic) These units are usually smaller than commercial units and areintended for use in small offices and in homes ndash typically for food storage However just like commercialunits they are not designed specifically for the storage of biological materials Such units are usually available in common home supply stores
Answers (Choose one)
Select grade A Pharmaceutical B CommercialHousehold
[O] CDC does not recommend the use of both sections or the freezer section only of combination commercialhousehold units
Review CDC Recommendation
CDC recommends the following vaccine storage unit types (in order of preference) pharmaceutical grade stand-alone orcombination units (preferred) householdcommercial stand-alone units householdcommercial combination units using therefrigerator section only
Goal of this question Assess the grade and type of each storage unit bull Pharmaceutical grade units may be stand-alone or combination units that are often metal may have glass in the door for viewing inside often have an external digital temperature display and are manufactured by medical companies
bull Commercial or household units often look like your kitchen appliance have vegetablemeat drawers in the unit and are manufactured by household appliance companies
bull Occasionally you might find a medical grade unit which is usually a commercialhousehold unit with a lock and 3-prong plug These are still considered household units because of their ability to maintain proper temperatures and air flow Studies show that household stand-alone units are better able to maintain consistent temperatures than their combination counterparts Combination household units used to store vaccine in both sections of the unit is no longer recommended and may be prohibited in the future Combination household storage units that are having difficulty maintaining a cold enough freezer temperature and a warm enough refrigerator temperature should be replaced or a separate stand-alone freezer should be purchased
For frozen vaccines the most cost effective solution is for the site to purchase a small stand-alone freezer The site may need time to budget for a stand-alone storage unit
Resources bull Replacing Combination Household Units Tip Sheet on IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml)
IPI Advisor Manual | February 2017 Page 33
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 434 Storage amp Handling Per Unit Temperature Monitoring Device in the Unit
Question 43 Determine whether there is a temperature monitoring device in this section of the storage unit andanswer the questions
A Is there a temperature monitoring device in this section of thestorage unit
Yes No [X] (If no skip to question 47)
B Who is responsible for supplying the temperature monitoring device in this section of the storage unit Provider
Review CDC Requirement
Certificates of calibration testing provide confidence that the temperature monitoring device is measuring temperaturesaccurately All units storing VFC vaccines must have a calibrated temperature monitoring device with a current and valid certificateof calibration testing All certificates must contain modeldevice name or number serial number date of calibration testing (report or issue date) and Instrument Passed testingInstrument in Tolerance (Recommended uncertainty = +-05ordm C (+-1ordm F))
Goal of this question Assess whether there is a temperature monitoring device in the unit If the unit is not being monitored at all call MDH at 651-201-5522 for guidance
Helpful information bull This question does not ask whether the temperature monitoring device is working or the characteristics of the device These issues will be addressed later in the questionnaire
bull For part B the provider is always responsible for supplying the temperature monitoring device Even if their thermometer or data logger was originally from MDH it is their responsibility to ensure it is functional and calibrated
Resources bull Section 8 in the MnVFC Policies and Procedures Manual
Page 34 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 444 Storage amp Handling Per Unit CDC Recommended Temperature Monitoring Device
Question 44 Assess the temperature monitoring device in this section of the storage unit to answer the questionsbelow
A Is the temperature monitoring device a continuous monitoring and recordingdevice (eg data logger)
Yes No [O] (Skip D)
B Does the temperature monitoring device have a probe in buffered material Yes No [O]
C Does the temperature monitoring device have a digital display that can beeasily read from the outside of this unit
Yes No [O]
D Is data downloaded and reviewed routinely Yes No [O]
Review CDC Recommendation
As of Jan 1 2018 all VFC providers must use continuous temperature monitoring devices (eg data loggers) to monitor vaccinesthat will be administered to VFC-eligible children Routine review and accessibility of temperature data is critical for determining whether vaccine has been properly stored and for assessing usability of vaccine that was involved in a temperature excursion Tomeet VFC Program requirements the device must also be equipped with bull A temperature probe bull An active temperature display that can be easily read from the outside of the unit bull The capacity for continuous monitoring and recording capabilities where the data can be routinely downloaded
The following are additional recommended features for these devices bull Alarm for out-of-range temperatures bull Current minimum and maximum temperatures display bull Low battery indicator bull Accuracy of +- 1degF (05degC) bull Memory storage of at least 4000 readings bull User programmable logging interval (or reading rate) recommended at a maximum time interval of every 30 minutes bull Use of a probe that best reflects the temperature of the vaccine (such as a buffered probe)
Goal of this question Assess the temperature monitoring device in the storage unit Note that these are all recommendations not requirements at this time
This is a great teaching opportunity for sites who do not currently have a continuous temperature monitoring device Beginning Jan 1 2018 all units that store MnVFC vaccine will be required to have a continuous temperature monitoring device (ie a data logger or a continuous temperature monitoring system) Unlike a minmax thermometer a continuous temperature monitoring device provides detailed information on all temperatures recorded at pre-set intervals For excursions it can provide information on when a temperature went out-of-range for how long and what the temperatures were This is essential information that vaccine manufacturers need to know to assess the viability of the vaccine following an excursion
Helpful information bull Sites are required to monitor and record temperatures twice daily however temperature excursions can easily occur in the 12 hours or longer between readings Continuous temperature monitoring can help manufacturers determine vaccine viability
bull Continue to encourage sites to document and evaluate minimum and maximum temperatures the storage unit reached since the last reading and respond appropriately to out-of-range temperatures
IPI Advisor Manual | February 2017 Page 35
The 2017 MnVFC Site Visit Paperwork Chapter 4
bull It is recommended that sites download and review data weekly Discuss with sites that reviewing temperature monitoring device data also includes responding appropriately if they identify out-of-range temps
bull There is sometimes confusion about the difference between a data logger and a continuous temperature monitoring system Here are some differences
Data Loggers Continuous Monitoring Systems Have an external display similar to thermometers May or may not have an external display Have a detachable probe Probe is usually attached to transmitter Need to be plugged into the computer or cradle to download information on a regular schedule
Wirelessly sends data to computer system
Create a file of data that needs to be saved on the computer
Data is stored within the system not a separate file
Doesnrsquot allow documentation of twice a day temperature checks in the file
May allow documentation of twice a day temperature checks within the system
More about the 2018 requirement for a continuous temperature monitoring device
Required Features bull The continuous temperature monitoring device must have Continuous monitoring and recording capabilities to track and record temperatures over time The capacity to routinely download temperature data to a computer (recommended at least weekly) or wirelessly transmit data Detachable probe in a bottle filled with a thermal buffer (eg bio-safe glycol) if the data logger needs to be detached in order to download data Active temperature display
Recommended Features bull MnVFC recommends continuous temperature monitoring devices with Alarm for out-of-range temperatures Accuracy within +-1degF (+- 05degC) Low battery indicator Display of current minimum and maximum temperatures Memory storage of at least 4000 readings User programmable logging intervals (eg the user can set how often the device records the temperature)
Note that these are all currently recommendations not requirements yet
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
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The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 45
Goal of this question Ensure the temperature monitoring device is properly calibrated The certificate of calibration testing means that the device has been tested and it is accurately measuring temperatures within established testing limits The certificate of calibration ensures that the device meets all the required components
Helpful information bull The provider is always responsible for having a current certificate of calibration (or copy) on-site
bull To be considered ldquovalidrdquo a certificate of calibration must contain these required elements Modeldevice name or number Serial number
4 Storage amp Handling Per Unit Certificate of Calibration Testing
Review CDC Requirement
Certificates of calibration testing provide confidence that the temperature monitoring device is measuring temperaturesaccurately All units storing VFC vaccines must have a calibrated temperature monitoring device with a current and valid certificateof calibration testing All certificates must contain modeldevice name or number serial number date of calibration testing (report or issue date) and Instrument Passed testingInstrument in Tolerance (Recommended uncertainty = +-05ordm C (+-1ordm F))
Question 45
Note to Reviewer
A
B
C
D
E
Review the certificate of calibration testing for the temperature monitoring device in this section of the storage unit and answer the questions below
bull How to determine certificate of calibration testing expiration date 1) Identify the certificate issuecalibration date 2) Apply the Immunization Program-required frequency for calibration testing Example If the
issuecalibration date is 12312013 and Immunization Program policy requires testing every twoyears the expiration date is 12312015
bull Certificates must include all of the below bull ModelDevice Name or Number bull Serial Number bull Date of Calibration Testing (Report or Issue Date) bull Instrument Passed testing (Instrument in Tolerance)
Is there a certificate of calibration testing for the temperature monitoring Yes device in this section of the storage unit No [X]
What is the date of calibration for the temperature monitoring device in this section of the storage unit
What is the certificatersquos date of expiration based on ImmunizationProgram policy (See note to reviewer to determine expiration date) [X] Follow-up is required if
certificate is expired
Does the certificate contain all the necessary items listed in the Note to Yes Reviewer No [X]
Who is responsible for supplying the current and valid certificate of Provider calibration for this temperature monitoring device
Date of calibration testing (report or issue date) Note If there is no expiration date the certificate expires 2 years from the date of calibration Whether the instrument passed or failed testing (or instrument in tolerancenot in tolerance)
bull Recommended element Documented uncertainty of +- 1degF [05degC]
If these elements are present the certificate is considered valid If the certificate contains information about the recommended element or the entity that issued the certificate that is helpful but not required
To determine if a certificate of calibration testing was issued by an appropriate entity check to see if the certificate indicates one or more of these items (this is the wording used to help sites evaluate if their calibration is accurate but is not required on the certificate itself to be considered valid)
bull Conforms to ISO 17025 bull Performed by an ILACMRA Signatory body accredited laboratory You can review this list of the ILAC MRA and Signatories (httpilacorgilac-mra-and-signatories)
bull Traceable to the standards maintained by NIST bull Meets specifications and testing requirements for the American Society for Testing and Materials (ASTM) Standard E2877 tolerance Class F (le 05 degC) or better
bull Includes reference to another acceptable accuracy validation method such as comparison to other traceable reference standards or tests at thermometric fixed points
Note CDC recommends that certifications be issued for the entire monitoring unit (detachable probe data logger etc) and not individual certificates for each component
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The 2017 MnVFC Site Visit Paperwork Chapter 4
For 45 E the provider is always responsible for supplying the current and valid certificate of calibration for a temperature monitoring device
bull Tip If the temperature monitoring device has a sticker on the back with the calibration date the site can usually call the company who calibrated the device and get a copy of the certificate if they donrsquot have one
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 46 4 Storage amp Handling Per Unit Probe Placement
Question 46 Is the probe properly placed in this section of the storage unit
Note to Reviewer ldquoProperlyrdquo means that the probe in a commercial or household unit is placed in a central area of the unitdirectly with the vaccines Probes should not be placed in the doors near or against the walls close to vents or on the floor of the unit The only allowable exemption related to this requirement is for providerswho have pharmaceutical storage units (built for vaccine storage) that have either (1) a built-intemperature monitoring device OR (2) a dedicated port for the probe that dictates the placement of theprobe
Answers (Choose one)
Yes No [X]
Review CDC Requirement
The probe must be placed in a central area of the section of the storage unit directly with the vaccines in order to properly measurevaccine temperature The probe should not be placed in the door near or against the walls close to vents or on the floor of theunit For pharmaceutical units with a built-in temperature monitoring device or a dedicated port for a probe that is not in thecenter of the section of the storage unit consult your Immunization Program for guidance on placement
Goal of this question Make sure the temperature monitoring device is in the best location to accurately measure the temperature of the vaccines stored in the unit
Helpful information bull The probe of the temperature monitoring device should be placed directly with the vaccines in the middle of the unit The ONLY allowable exception is for pharmaceutical storage units that have either a built-in thermometer or a dedicated port for the probe that indicates placement of the probe
bull Temperatures can vary within the unit especially household units bull Call MDH at 651-201-5522 if you have questions
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Guide (wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml)
Page 38 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 474 Storage amp Handling Per Unit Temperature Documentation
Question 47 Review the temperature documentation over the past three months for this section of the storage unit todetermine whether the provider has a process in place for properly documenting temperatures twice aday Answer the questions below
A Are there two temperature readings recorded for this section of the storage unit per day
Yes No [X]
B Is there a time date and name (or initials) recorded for each reading Yes No [X]
C What is the current temperature and minmax temperatures (if available) inthis section of the storage unit Use the reviewerrsquos thermometer if the providerrsquos temperature monitoringdevice does not have a current valid certificate of calibration testing or the probe is not properly placed in this section of the storage unit
Current Temperature Minimum Temperature Maximum Temperature Fahrenheit Celsius
D Based on your review of the providerrsquos recent temperature documentationincluding the current temperature is this section of the storage unitmaintaining appropriate temperatures
Yes No [X] Not enough information [X]
Review CDC Requirement
Vaccines must be stored under appropriate temperatures as described in the package inserts at all times Acceptable temperature ranges vary by vaccine type and the range is 36deg F and 46deg F (2deg C and 8deg C) and for frozen vaccines the range is -58deg F and +5deg F (shy50deg C and -15deg C) Exposure to temperatures outside of those included in the package inserts could affect vaccine viability andultimately could leave children unprotected against vaccine-preventable diseases In order to maintain awareness of storage unittemperatures and ensure that vaccines are being stored at appropriate temperatures at all times VFC providers are required to monitor and document temperatures for all vaccine storage units at least twice a day Temperature documentation must contain (1) at least two temperature readings per day (2) the time and date of each reading and (3) the name (or initials) of the personwho assessed and recorded the readings CDC also recommends that VFC providers record the minimum and maximumtemperatures of each unit once each workday (preferably in the morning)
Goal of this question Ensure the temperature is being monitored twice daily is within the required range and documented correctly Use your thermometer to check the temperature if the sitersquos temperature monitoring devicersquos probe is not properly placed or there is not a current certificate of calibration Place your thermometer in the unit at the beginning of the visit to allow sufficient time to reach an accurate temperature The purpose of using your thermometer is to ensure the vaccine is being stored at the proper temperature not to ldquovalidaterdquo their reading
Question 47 D is an assessment question based on information you have learned during your visit You might answer ldquonot enough informationrdquo if the unit is new and they donrsquot have at least three months of data or if the unit is only used as overflow and they are inconsistent with temperature monitoring Mark ldquoNordquo if you have reason to believe the storage unit is not maintaining temperatures properly
Helpful information bull All sites must document temperatures twice a day every day the site is open even if they have a data logger or continuous monitoring system
bull Sites can document the information electronically with some continuous monitoring systems as long as it can show what the current temp is the date time and initials of the person checking ndash this needs to be someone at the site ndash not checking remotely or centrally for a large site or system The site must be able to produce these records during their site visit Reviewing these files can be a challenge due to large volumes and lots of paper
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Temperature Logs on Managing Vaccine (wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml)
IPI Advisor Manual | February 2017 Page 39
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 484 Storage amp Handling Per Unit Temperature Excursions
Question 48 In the event that a temperature excursion(s) occurred in this unit within the last three months requestand review documentation of actions taken to determine whether the provider has a process for properlyaddressing excursions Answer the questions below
A Were vaccines in this unit exposed to out-of-range temperatures in the lastthree months (including today)
Yes No (If no skip to question 49)
B Did the provider quarantine and label vaccines as ldquoDo not userdquo Yes No [X]
C Did the provider place vaccine in a unit where it can be stored under properconditions if applicable
Yes No [X]
D Did the provider contact the Immunization Program to report theexcursion
Yes No [X]
E Was the manufacturer contacted for documentation supporting theusability of the vaccine
Yes No [X]
Review CDC Requirement
The provider must document all excursions and actions taken including the following (1) Quarantine and label vaccines as ldquoDO NOTUSErdquo (2) Place vaccines in a unit where they can be stored under proper conditions (3) Contact the Immunization Program to report an excursion and (4) Contact the vaccine manufacturer to obtain documentation supporting the usability of the vaccine
Goal of this question Address any out-of-range temperatures (temperature excursions) identified in reviewing the last three months of temperature logs or during the site visit If there were any out-of-range temperatures did the site respond appropriately to the situation This is a great opportunity to discuss what to do in the event of an excursion The Clinicians Storage and Handling Mishap Checklist is in the IPI Site Visit information folder and is a good review of the process
Helpful information bull Sites need to know that an excursion does not automatically mean that exposed vaccines are non-viable or unusable Exposed vaccines must be quarantined (marked ldquoDo Not Userdquo) and stored under proper conditions until they have received information from vaccine manufacturers regarding the viability of the vaccine
bull Sites must inform MDH when an excursion occurs
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Clinicians Storage and Handling Mishap Checklist (wwwhealthstatemnusdivsidepcimmunize ipivaxchklstpdf)
Page 40 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 49
Goal of this question Ensure proper placement of vaccines in the storage unit
Note These are all recommendations (best practices) not requirements
Helpful information bull Store vaccine in the middle of the compartment two to three inches away from the coils walls floor and cold air vent The temperature near the floor and walls of the unit differs from that in the middle of the compartment and the cold air vent can freeze refrigerated vaccines
4 Storage amp Handling Per Unit Vaccine Placement
Question 49 Look inside the unit to answer the questions below
A Are vaccines placed in the middle of the unit with space between vaccinesand the sideback of the unit to allow cold air to circulate
Yes No [O]
B Are vaccines stored in their original packages Yes No [O]
C Are there water bottles (for refrigerators) or frozen water bottles (forfreezers) in the unit
Yes No [O]
D Are vaccines store in the doors vegetable bins under or near cooling ventsor on the floor of the unit
Yes [O] No
E Is food being stored in the unit Yes [O] No
Review CDC Recommendation
Vaccines should be stored in their original manufacturer (or CDC centralized distributor) packaging They should be placed in the middle of the unit with space between the vaccines and the sideback of the unit to allow cold air to circulate Vaccines SHOULD NOT be stored in the doors vegetable bins or floor of the unit or under or near cooling vents and there should not be any food inthe unit Water bottles (for refrigerators) or frozen water bottles (for freezers) should be placed throughout each storage unit inorder to (1) stabilize or extend temperatures during a power outage and (2) to serve as physical blocks preventing the placementof vaccines in areas of the unit that are at higher risk for temperature excursions (such as in doors vegetable bins floor ornearunder cooling vents)
bull Vaccines should be kept in their original packaging to Protect them from light Help prevent medication errors by making labels easier to read Provide a moisture barrier that serves as insulation in case of an out-of-range temperature power outage door left open or mechanical failure Simplify managing vaccine inventory
bull Store water bottles in the doors on the floor and near the cold air vent in the refrigerator and frozen water bottles in the freezer to help maintain a stable temperature if there is a power failure and when the door is opened frequently Too many water bottles in the door can prevent the door from closing tightly Mark water bottles ldquoDo Not Drinkrdquo
bull Do not store vaccine in the door or drawers of the refrigerator or freezer Vegetable bins and crisper drawers should be removed from refrigerators or used to store other medical supplies or water bottles
bull If vaccine is stored in a household combination refrigeratorfreezer The top shelf should not be used for storing vaccine because the cold air vent blowing from the freezer will freeze vaccine located there If you must use the top shelf of this type of unit place water bottles underneath the cold air vent to prevent vaccine from being stored there It is recommended that only the refrigerator be used for vaccine storage and a separate stand-alone freezer be used to store frozen vaccine
bull Must not store food or beverages in the refrigerator or freezer because frequent opening of doors can lead to temperature variations that may affect vaccine viability There is also a risk of contaminating vaccines
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Guide (wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml) bull Vaccine Storage Tip Sheet on IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml)
IPI Advisor Manual | February 2017 Page 41
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 4104 Storage amp Handling Per Unit Disconnection from Power Source
Question 410 Ask the provider to demonstrate what measures are taken to ensure that vaccine storage units are notaccidentally physically disconnected from the power supply Which of the following describes the measure(s) taken on this unit
Note to Reviewer bull Large hospitals and healthcare systems may not have the ability to demonstrate labels on plugs or circuitbreakers In such cases verify that the practice has a comprehensive policy and standard operatingprocedures in place to prevent the vaccine storage unit from being physically disconnected from thepower supply
bull While back-up generators may ensure power to the overall facility this question ONLY addresses thevaccine storage unit being accidentally disconnected from the power source either through the plug orthe circuit breaker
Answers A ldquoDo not disconnectrdquo labels on the plug (Choose all that B ldquoWarningrdquo label on the circuit breaker box
apply) C Hard-wired (ie built-in) and has a ldquoDo not disconnectrdquo label on thecircuit breaker box D Hospital or large health care system with a comprehensive written policyand standard operating procedures detailing measures taken to preventvaccine storage units from being accidentally disconnected from the powersupply E No acceptable measures for preventing accidental disconnection frompower supply [X]
[X] The response is non-compliant if only A only B or E is selected
Review CDC Requirement
VFC providers must take steps to protect the power source for all vaccine storage equipment by means of having clear warninglabels on both the plug and the circuit breaker associated with all vaccine storage units Large hospitals and healthcare systems canmeet this requirement by demonstrating that they have comprehensive policies and standard operating procedures to preventvaccine storage units from being physically disconnected from the power supply
Goal of this question Decrease the chance that a vaccine storage unit will be accidently unplugged or power will be turned off while vaccine is in the unit This question addresses only what measures the site has taken to ensure the storage unit is not physically disconnected from its power source
If the site uses labels on the plugs and circuit breakers perform a visual inspection to assess whether the way the stickers are positioned make it clear and obvious to anyone that these units are not to be disconnected
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Do Not Unplug and Warning stickers are included in the folder or available to order on the For
Professionals Order Form (wwwhealthstatemnusdivsidepcimmunizeordermathtml)
Note Once you have completed the 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet for each unit return to the questionnaire to complete sections 5 and 6
Page 42 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
- -
Section 5 Storage amp Handling Site-Wide Question 51
5 Storage amp Handling Site Wide Discussion of Cost amp Quantity of Vaccine
Question 51 Have a discussion with the provider about the cost and quantity of VFC vaccines they are responsible for annually Address the points listed in the note to reviewer below
Note to Reviewer bull Vaccine Shipped (Required) Share the cost of VFC vaccines shipped to the provider in the last calendaryear to make sure the provider understands the contribution made by the VFC Program to their practiceFor new providers who do not have ldquocalendar yearrdquo data share either the actual cost of their currentinventory or use the cost of 10 VFC doses of each of the ACIP-recommended vaccines (approximately $7000) to help estimate their annual cost
bull Storage amp Handling (Required) Make sure the provider understands the cost of vaccines for which they are responsible when they make decisions about purchasing recommended vaccine storage and temperature monitoring equipment
Answer I have discussed with the provider the cost and quantity of vaccines ordered in the previous calendar year
Goal of this question Inform sites of the quantity and value of vaccines that they receive as part of the MnVFC program Providers often donrsquot realize the value of the vaccine in their unit This information is included on your clinic list and on the one page site-specific information
Helpful information bull This discussion must occur and the box on the questionnaire must be checked bull If there isnrsquot actual vaccine value information available tell the site that one vaccine order that includes a box of each of the ACIP recommended vaccines costs approximately $7000
bull MDH may not have specific information for individual sites if they receive vaccine from a central warehouse or pharmacy For those sites MDH will give you numbers for the whole system so you can discuss system wide data as appropriate If individual site information is also included it is usually just varicella-containing vaccines that must be shipped directly to the site
Question 52
5 Storage amp Handling Site Wide Dorm Style Units
Question 52 Determine whether the provider has any dorm-style units on site and answer the questions below
Note to Reviewer A dormitory-style refrigerator is a unit that has both refrigerator and freezer compartments behind a singleexterior door Dorm-style units also have an evaporator plate (cooling coil) which is usually located insidean icemaker compartment (freezer) within the refrigerator
A Does the provider have any dorm-style units that are used at any time tostore vaccines
Yes [X] No (Skip to question 53)
B Does the provider have sufficient space in existing compliant vaccinestorage units to store all vaccines without use of the dorm-style unit at any time
Yes No [X]
Review CDC Requirement
Dorm- and bar-style units are prohibited for vaccine storage Vaccines stored in dorm-style units are considered non-viable and must be returned to the centralized distributor CDC recommends the following vaccine storage unit types (in order of preference)pharmaceutical grade stand-alone or combination units (preferred) householdcommercial stand-alone unitshouseholdcommercial combination units using the refrigerator section only
Goal of this question Ensure no vaccine is stored in dorm-style units even for short periods of time Encourage them to label any units ldquoNo Vaccine Storage Allowedrdquo Vaccine stored in these units is considered non-viable If a site is using a dorm-style unit call the MnVFC program (651-201-5522)
Resource Section 8 in the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 43
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 535 Storage amp Handling Site Wide Storage Unit Space Availability
Question 53 Does the provider have sufficient room across storage units to store current stock as well as anyadditional stock acquired during peak season without overcrowding
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have sufficient storage space to accommodate vaccine stock at the busiest time of year without overcrowding
Goal of this question Ensure that sites have sufficient space in their units to maintain vaccines at the busiest time of year Overcrowding of vaccine limits air circulation and affects the unitrsquos ability to maintain stable temperatures
Helpful information bull Look for signs of overcrowding such as vaccines that are pushed up against the wall bins that are overflowing or storage units that are full during non-peak seasons
Discuss immediate actions if the unit is overcrowded Move some of their vaccines order less vaccine more frequently (once per month preferably) andor purchase another storage unit for overflow
Resource bull Section 8 MnVFC Policy and Procedure Manual
Page 44 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 545 Storage amp Handling Site Wide Expired Vaccines
Question 54 Look in each unit Are there expired vaccines in any of the vaccine storage units at this site
Answers (Choose one)
Yes [X] No
Review CDC Requirement
Vaccines should be rotated weekly and when a new shipment comes in so that longer-dated vaccines are stored behind shorter-dated vaccines If vaccines expire they can no longer be stored in the same storage unit with viable vaccines They must be placedin a container or bag clearly labeled ldquoDo not userdquo and separated from viable vaccines to prevent inadvertent use Expired vaccinemust be returned to the centralized distributor within six months of expiration
Goal of this question Ensure there is no expired vaccine in any storage unit
Helpful information bull Sites can prevent their stock from expiring by rotating vaccines every week andor when a new shipment arrives Longer-dated vaccines are stored towards the back of the unit and shorter-dated vaccines are up front
bull Pay attention to vaccines that expire within the next three months Consider transferring vaccine that will expire soon to another MnVFC-enrolled site that will use the vaccine preferably a site close by It is the transferring sitersquos responsibility to arrange the transfer of the vaccine Be sure to complete the MDH Vaccine Transfer Record form and send it to MDH If they are having difficulty finding a location to accept vaccine contact MDH
bull This is a great opportunity to educate sites about the MDH Nonviable Vaccine Form and the process for returning vaccine The VFC program does get some credit for taxes and fees on vaccine that is returned to the distribution center
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MDH Nonviable Vaccine Form and MDH Vaccine Transfer Record on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfcformshtml)
IPI Advisor Manual | February 2017 Page 45
The 2017 MnVFC Site Visit Paperwork Chapter 4
- -
-
Question 555 Storage amp Handling Site Wide Back up Thermometer
Question 55 Does the provider have a readily available back-up thermometer with a current and valid certificate ofcalibration testing
Note to Reviewer ldquoReadily availablerdquo means that the thermometer is available to perform twice-a-day monitoring for a unit asrequired CDC recommends that the back-up thermometer be maintained on site
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have a readily available back-up thermometer with a current and valid certificate of calibration testing Toprevent the certificates of calibration testing of the primary and back-up thermometers from expiring at the same time the date of calibration testing (or issue date) of the back-up thermometer should be different from the date of calibration testing (or issue date) of the primary thermometer As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meetsVFC program requirements
Goal of this question Ensure sites have one calibrated back-up thermometer onsite that is readily available in the event that the temperature monitoring device in unit fails transportation of vaccine is needed or there are other unexpected circumstances
Helpful information bull As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meets VFC Program requirements
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 56 5 Storage amp Handling Site Wide Preparation of Vaccine
Question 56 When does this provider prepare vaccine for administration to the patient
Note to Reviewer For mass vaccination clinics if one type of vaccine is offered providers may pre-draw up to 10 doses Ifusing pre-filled syringes pre-drawing also means activating the syringe by removing the needle guard orattaching a needle
Answers (Choose all that
apply)
Prepare dose immediately before administration Pre-draw doses for upcoming patients (in a regular clinicpractice) [O] Pre-draw up to 10 doses (in a mass-vaccination clinic) Pre-draw more than 10 doses (in a mass-vaccination clinic) [O] Other [O]
Review CDC Recommendation
CDC recommends preparing vaccines immediately prior to administration in order to assure viability of vaccine and prevent vaccinewastage Vaccines that are not administered immediately are at risk of exposure to temperatures outside of the required rangewhich can affect vaccine viability and ultimately can leave children unprotected against vaccine-preventable diseases
Goal of this question Discuss proper timing and preparation of vaccine(s) for administration These are recommendations not requirements
Helpful information bull Educate staff on the importance of preparing vaccine immediately before administration Pre-drawing of vaccines may lead to concerns related to vaccine viability potency sterility and wastage
Page 46 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 6 Inventory Question 61
6 Inventory Inventory Comparison
Question 61 Visually inspect storage units to determine if existing supply of vaccines proportionately mirrorspopulations served Choose the most accurate statement below
Note to Reviewer bull CDC recommends that providers maintain a four-week supply of inventory bull For this question do not take into account vaccine types that the provider does not order Here simply
make sure that overall the vaccines in the providerrsquos storage units are available in sufficient amounts toserve their patient population
Answers (Choose one)
The current vaccine inventory proportionately reflects the populations identified Only public stock is insufficient [X] Only private stock is insufficient [X] Both public and private stock are insufficient [X] Site uses the replacement method but does not appear to have enough vaccine for their population [X] Other [X]
Review CDC Requirement
VFC providers must order and stock routine vaccines in accordance with their patient population in order to prevent missedvaccination opportunities Having sufficient amounts of all stocks prevents the inadvertent use of VFC vaccines for non-VFC-eligiblepatients and vice versa
Goal of this question Assess whether the site is ordering appropriate quantities of vaccine for the population they serve at their site
Helpful information bull If the site sees 30 percent private-pay patients and 70 percent VFC the stock in their storage units should reflect that proportion If you donrsquot know you can ask the site about their population
bull This is meant to be a general assessment so in a big site if they have only a small amount of vaccine that may indicate an issue with vaccine management
bull CDC recommends smaller more frequent orders (ie monthly) rather than large orders to minimize the amount of vaccine loss if an incident occurs during shipment or in the storage unit Sites should not order more frequently than once a month
bull Sites using the replacement method will only have one stock but it should appear to be large enough for their population
bull Only assess the vaccine types that the site currently stocks in their unit We know there are sites that do not offer all ACIP-recommended vaccines for various reasons That issue will be addressed in question 62
IPI Advisor Manual | February 2017 Page 47
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 626 Inventory ACIP Recommended Vaccines
Question 62 Review providerrsquos current inventory to answer the questions below
A Does the provider offer all routine ACIP-recommendedvaccines for their patient population
Yes (Skip to question C) No [X] Offers all except varicella because direct ship ofvaccine is unavailable from manufacturer
B Which routine vaccines are NOT being offered DTaP Hepatitis A Hepatitis B HIB HPV Influenza Meningococcal
MMR Pneumococcal Polio Rotavirus TdapTd Varicella
C According to Immunization Program Policy does theprovider make accessible all non-routine ACIP-recommended vaccines for those VFC patients whomeet the criteria for receiving them
Yes (Skip to question 63) No [X]
D Which non-routine vaccines are NOT being offered Pneumococcal polysaccharide vaccine (PPSV23) Meningococcal Group B (MenB) Other
Review CDC Requirement
VFC providers agree to comply with immunization schedules dosages and contraindications that are established by the Advisory Committee on Immunization Practices (ACIP) for the vaccines identified and agreed upon in the Provider Agreement UNLESS bull In the VFC providers medical judgment and in accordance with accepted medical practice the VFC provider deems such
compliance to be medically inappropriate for the child bull The particular requirements contradict state law including laws pertaining to religious and other exemptions The VFC program entitles children to the following vaccines DTaP Hepatitis A Hepatitis B HIB HPV Influenza MeningococcalMMR Pneumococcal Polio Rotavirus TdapTd and Varicella VFC providers are also required to ensure that VFC-eligible children have access to non-routine vaccines as needed
Goal of this question Assess if the site is offering all the ACIP-recommended vaccines for the population they serve and these vaccines are in stock on the day of the visit It is important that every MnVFC-eligible child that comes to a providerrsquos office for an immunization is vaccinated
Helpful information bull The Advisory Committee on Immunization Practices (ACIP) is a group of medical and public health experts that develops recommendations on how to use vaccines to control diseases in the United States
bull Specialty providers are not required to offer all routine vaccines but should provide the vaccines appropriate for their population
bull If the site does not offer all routine ACIP-recommended vaccines appropriate for their population check the ldquoNordquo box in Part A then check the appropriate box(es) in Part B for any vaccines not offered Please contact MDH as this situation offers us the opportunity to provide education to the site
bull For non-routine vaccines they must either be in stock or the site must have an alternative protocol in the routine management plan that ensures these children have access when applicable
Resources bull IAC Diseases and Vaccines (wwwimmunizeorgvaccines) bull CDC Advisory Committee on Immunization Practices (ACIP) (wwwcdcgovvaccinesacipindexhtml)
Page 48 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 636 Inventory Separation of Stock
Question 63 Observe how the provider differentiates stock in each storage unit to answer the questions below
A Is it clear which vaccines belong to public stock andwhich belong to private stock
Yes No [X] Not applicable replacement site
B Is it clear which vaccines belong to VFC stock andwhich belong to UUAV stock
Yes No [X] Not applicable replacement site Not applicable not UUAV-enrolled site
Review CDC Requirement
In order to ensure that VFC vaccines are only administered to VFC-eligible children VFC providers that serve both VFC and non-VFCshyeligible children must maintain their vaccine inventories in such a way that they can clearly differentiate public stock from privatestock as well as VFC from other public stock
Goal of this question Assess whether the site can distinguish between MnVFC vaccine and private vaccine If they participate in the Uninsured and Underinsured Adult Vaccine (UUAV) program they should also be able to distinguish between MnVFC stock and UUAV stock Some sites use labels bins boxes etc to differentiate their stock If it is not clear how the site differentiates their stock discuss vaccine management with the staff For follow-up call MDH to discuss doing a follow-up site visit
Sites using the replacement method will not have separate stocksmdashthis is an approved alternative method for keeping track of vaccine
Resource bull Section 10 of the MnVFC Policy and Procedure Manual
IPI Advisor Manual | February 2017 Page 49
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
MnVFC Site Visit Storage and Handling Per Unit Answer Sheet 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet MnVFC PIN ___________________
Question number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
Temperature Monitoring Device Questions Questions 43 47 must be answered separately for the freezer and refrigerator if the unit is a combo Be sure to document responses in the appropriate column
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
All the questions on the Site Visit Storage amp Handling Per Unit Answer Sheet have been discussed previously in section 4 of this manual Use this sheet to record information about all the units at the site visit You will need one sheet for each unit If it is a combination unit (either pharmaceutical or household) you can record both sections on one sheet If they have stand-alone units use one sheet for each unit Do not enter the answers to the questions in section 4 of the questionnaire
If you need more information about any of the questions refer back to the main questionnairemdashthe complete question additional guidance including notes to the reviewer and the CDC requirements are there Also if the site is not meeting the requirement you will go back to the questionnaire to complete the ldquoActions if Non-compliantrdquo section including the root cause analysis and follow-up sections
When you have completed the assessment of all the storage units remember to go back to the questionnaire to complete sections 5 and 6
Page 50 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
ndash
ndash
MnVFC Provider Follow-up PlanThe goal of the Provider Follow-up Plan is to communicate with the site all of the VFC requirements any unmet requirements found during your site visit and the timeline for completing the required action The left hand column is a box to check for ldquoUnmetrdquo requirements
Helpful information bull The form can be used to review what the site is doing well and what they need to work on
bull For requirements that have specific documentation that needs to be sent to you use the notes section
2017 MnVFC Provider Follow-up Plan Site _______________________________________________ MnVFC PIN ____________ Date of Visit ___________
Thank you for participating in this MnVFC compliance site visit Please review this visit summary including follow-up actions and timelines for completion Unmet MnVFC requirements and recommendations have a checked box next to them The goal of this plan is to support you with successfully implementing the program and improving access to vaccines for VFC-eligible children
Unmet Question VFC Requirements Section 1 Changes to Key Staff
Q12 Change in the Medical Director Immunization Manager Vaccine Coordinator or back-upKey Staff must be communicated to the immunization program by emailing healthmnvfcstatemnus Changes Notes
Q12 Key staff must complete the annual training on VFC program requirements and print theAnnual Training certificate of completion Documentation Required Action
Staff that have not completed the MnVFC online training must complete it and send acopy of the certificate to the reviewer Training can be found on the MnVFC website (wwwhealthstatemnusvfc) Due date 1 month
Notes
Unmet Question VFC Requirements Section 2 Eligibility
Q21 Provider staff must possess a working knowledge of all VFC eligibility criteria and use thoseVFC Eligibility criteria to screen children prior to administering VFC vaccines
Categories Notes
bull This form provides documentation needed for follow-up actions when you send your thank you email
The second to last page of the Provider Follow-up Plan has a summary of the MnVFC program recommendations These are to remind the site about best practices they may want to improve upon even though they are not yet requirements of the program For example you could discuss the recommendation about storage units if they currently have a combination household unit and are using both sections
The last section is for your signature and the person you met with In most sites it will be the immunization manager or vaccine coordinator who signs the form unless the medical director attended the site visit You keep the original copy and the site will need to keep a copy for themselves
To be completed by the site visit reviewer
I acknowledge that a VFC site visit was performed on __________________ (visit date) The follow-up plan which includes a list of all current VFC program requirements and recommendations assessed during the visit and any required follow-up actions was provided at the end of the visit
Site visit reviewer
Phone
Reviewer Signature Date
To be completed by the provider
I acknowledge that our practice took part in the VFC site visit noted above I understand the findings of the visit and any required actions that must be taken by our office in order to meet VFC program requirements
Medical Director (or designee) Name Title
Medical Director (or designee) Signature Date
IPI Advisor Manual | February 2017 Page 51
The 2017 MnVFC Site Visit Paperwork Chapter 4
After the Site Visit Send a thank you email highlighting the unmet requirements documents you need from the site to resolve the issue(s) and the date you need them Make sure to include the link to the Site Visit Survey (httpssurveyvovicicomseashxs=56206EE334CE0B14)
Please refer to Chapter 3 for more information about future follow-up required after the visit including forms and documentation
Resource bull Sample Thank You letter on IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml)
Chapter 5
IPI Advisor Resource List MnVFC Program 651-201-5522
MnVFC wwwhealthstatemnusvfc
bull Separate Stock and Replacement Method Policies and Procedures Manuals bull Online trainings bull MnVFC Announcements sign up to receive them via email bull Ordering MDH vaccine bull MnVFC forms Screening forms Reporting forms Others MDH Nonviable Vaccine Form MDH Vaccine Transfer Record and Vaccine Borrowing Report
bull MnVFC promotional materials bull Immunization Billing Guidance for MnVFC and Immunization Billing Guidance for MnVFC Replacement Sites Immunization Practices Improvement Program (IPI) wwwhealthstatemnusdivsidepcimmunizeipi
bull IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml) bull IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml) IPI Resource Folder Contents (wwwhealthstatemnusdivsidepcimmunizeipiipifolderpdf)
Minnesota Immunization Information Connection (MIIC) wwwhealthstatemnusmiic
bull MIIC regions and regional coordinators
Clinical Practice MDH Immunization Program wwwhealthstatemnusimmunize
Got Your Shots News wwwhealthstatemnusdivsidepcnewslettersgys
MDH Immunization Information for Health Care Providers wwwhealthstatemnusdivsidepcimmunizehcp
bull Got Your Shots A Providers Guide to Immunization in Minnesota bull Vaccine protocols bull Forms for tracking patient immunizations bull Immunization schedules for Health Care Providers Immunization Action Coalition (IAC) wwwimmunizeorg
bull Ask the Experts bull VISs (Vaccine Information Statements and translations) bull Administration screening questions bull Medical management of vaccine reactions bull Order form for Californiarsquos Immunization Technique DVD Best Practices with Infants Children and Adults
Page 52 IPI Advisor Manual| February 2017
IPI Advisor Resource List Chapter 5
CDC ldquoPink Bookrdquo wwwcdcgovvaccinespubspinkbookindexhtml
CDC Advisory Committee on Immunization Practices (ACIP) wwwcdcgovvaccinesacip
CDC Vaccines and Immunizations wwwcdcgovvaccines
VAERS reporting httpvaershhsgovindex
Storage and Handling Got Your Shots Providers Guide ndash Managing Vaccine wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml
MnVFC Guide to Temperature Monitoring Devices wwwhealthstatemnusvfc
MDH Clinicianrsquos Vaccine Mishap Checklist wwwhealthstatemnusdivsidepcimmunizeipivaxchklstpdf
MDH Vaccine Storage Guide wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml
CDC Vaccine Storage and Handling Toolkit wwwcdcgovvaccinesrecsstoragetoolkit
You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Vaccine manufacturer phone numbers wwwcdcgovvaccinespubspinkbookdownloadsappendicesFcontact-info-manufactpdf
IAC Checklist for Safe Vaccine Handling and Storage wwwimmunizeorgcatgdp3035pdf
IAC Donrsquot Be Guilty of These Errors in Vaccine Storage and Handling wwwimmunizeorgcatgdp3036pdf
Additional Resources Print materials from MDH ndash order forms wwwhealthstatemnusdivsidepcimmunizeordermathtml
Vaccine Education Center ndash Childrenrsquos Hospital of Philadelphia wwwchopeduservicevaccine-education-centerhomehtml
California Department of Public Health ndash Interactive training on vaccine administration and storage and handling handout on transporting vaccine and how to package wwwezizorg
IPI Advisor Manual | February 2017 Page 53
IPI Advisor Resource List Chapter 5
CDC vaccine price list wwwcdcgovvaccinesprogramsvfcawardeesvaccine-managementprice-listindexhtml
Vaccine Information Statements (VIS) wwwcdcgovvaccineshcpvisindexhtml
CEU Opportunities CDC Immunization Education and Training wwwcdcgovvaccinesedindexhtml
Immunization You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Page 54 IPI Advisor Manual| February 2017
- Introduction
-
- Welcome to the Immunization Practice Improvement (IPI) Program
- Contact Information
-
- Chapter 1
- Requirements to Participate in the MnVFC Program
- Vaccines for Children Program
- Chapter 2
- Reimbursement for MnVFC Visits
- Types of Visits
- Your MnVFC Clinical CoordinatorPlanner
- New IPI Advisor Training Requirements
- Your Role as an IPI Advisor
- Reasons MDH Would Do All or Part of a Visit
- Chapter 3
- Future follow-up
- Conducting the Visit
- Preparing for the Visit
- Information for the Visit
- Site Visit Checklist
- Scheduling the Visit
- Chapter 4
- After the Site Visit
- MnVFC Provider Follow-up Plan
- MnVFC Site Visit Storage and Handling Per Unit Answer Sheet
- Section 6 Inventory
- Section 5 Storage amp Handling Site-Wide
- Section 4 Storage amp Handling Per Unit
- Section 3 Documentation
- Section 2 Eligibility
- Section 1 Provider Details
- The Site Visit Reviewer Legend
- MnVFC Site Visit Questionnaire
- Required Paperwork for Site Visits
- Chapter 5
-
Page 28 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 36
3 Documentation Vaccine Management Plan
Question 36 Physically review the providerrsquos Vaccine Management Plan to answer the question below
A Does the provider have a Vaccine Management Plan Yes No [X] (If no skip to question 37)
B Does the plan list the current Immunization Manager Vaccine Coordinator andback-up
Yes No [X]
C Does the plan address proper vaccine storage and handling practices Yes No [X]
D Does the plan specify vaccine receiving procedures Yes No [X]
E Does the plan contain procedures for what to do with vaccine in the event of an emergency
Yes No [X]
F Does the plan contain procedures for vaccine ordering Yes No [X]
G Does the plan address inventory control (example stock rotation) Yes No [X]
H Does the plan address how to handle vaccine wastage Yes No [X]
I Does the plan address staff training and documentation on vaccine managementstorage amp handling
Yes No [X]
J Does the plan contain a review date that falls within the last 12 months Yes No [X]
K Has the plan been signed by the individual responsible for its content Yes No [X]
Review CDC Requirement
VFC providers must develop maintain and implement a Vaccine Management Plan for routine and emergency vaccinemanagement The plan must contain the current Vaccine Coordinator and back-up proper storage and handling practicesshipping and receiving procedures emergency procedures procedures for vaccine ordering inventory control (eg stock rotation)how to handle vaccine wastage and staff trainingdocumentation on vaccine management storage and handling The plan must bereviewedupdated annually or more frequently if changes occur A ldquoreview daterdquo and signature are required on all plans in order tovalidate that they are current
Goal of this question Evaluate the sitersquos plan for vaccine management It is especially important that they have a plan for emergency management of their vaccine in the case of equipment failure or power outage Encourage all sites to read and sign the MnVFC Policies and Procedures Manual and complete the emergency plan or be able to show you a plan of their own
If the provider is not able to physically show you the plan at the time of the visit or if the recorded review date is not within the last 12 months you must mark that this requirement is unmet The Vaccine Management Plan is important in times of emergency and it should be easy to access by any staff member at any time Encourage them to post the plan and put a copy with the packing supplies
Helpful information bull Encourage the site to fill in the ldquoImmunization Managerrdquo and ldquoVaccine Coordinatorrdquo fields in the
MnVFC Policies and Procedures Manual for their own referencebull The emergency plan in the manual can be reviewed from last year and included in this yearrsquos manual (with an updated signature and date) if there have not been any changes
bull If information in the plan is outdated site staff will not be well equipped to safely manage vaccines in the event of a power-outage or other emergency situation
bull If their institutional policy is only reviewed and updated every 3-4 years (as many are) the staff may need to sign the MnVFC Polices and Procedure Manual to meet this requirement
Resource Routine Vaccine Management Plan and Emergency Vaccine Management Plan in the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 29
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 37
3 Documentation VIS amp VAERS
Question 37 Review the providerrsquos Vaccine Information Statements (VISs) and discuss providerrsquos VAERS process toanswer the questions below
A Does the provider have readily available up-to-date VISs for all ACIP-recommendedvaccines relevant to the populations it serves
Yes No [X]
B Does the provider make a VIS available for patientsparents before eachvaccination
Yes No [X]
C Does the provider know how and when to report clinically significant adverseevents using VAERS
Yes No [X]
Review CDC Requirement
VFC providers are required to distribute the current Vaccine Information Statements (VIS) each time a vaccine is administered and maintain records in accordance with the National Childhood Vaccine Injury Act (NCVIA) which includes reporting clinicallysignificant adverse events to the Vaccine Adverse Event Reporting System (VAERS) For a list of current VISs visit CDCrsquos Vaccine Information Statements (httpwwwcdcgovvaccineshcpvis) website
Gal of this question Ensure the site has the most current VISs and is giving them to each patientparent before administering the vaccine in compliance with the federal law Parents must be educated about the vaccine their child will receive and be aware of possible contraindications and side-effects in order to make well-informed decisions about their childrsquos health
Helpful information bull Ask to see the sitersquos VISs to determine if they have an active protocol for giving VISs to parents Review to make sure they are current Ask if they know where and how to report vaccine adverse events
Resources bull Section 3 in the MnVFC Policies and Procedures Manual bull CDC Vaccine Information Statements (wwwcdcgovvaccineshcpvisindexhtml) Site may sign up for email updates for the current list of VIS publication dates for the most up-to-date version
bull IAC Itrsquos Federal Law You must give your patients current Vaccine Information Statements (wwwimmunizeorgcatgdp2027pdf)
bull VAERS (httpsvaershhsgovindex)
Question 38
3 Documentation Anaphylaxis protocol
Question 38 Does the site have an anaphylaxis protocol which is clearly posted near the emergency kit
Answers (Choose one)
Yes No [X]
Review CDC Requirement
An anaphylaxis protocol must be clearly posted in the area where vaccines are administered
Goal of this question Make sure site is prepared for a severe allergic or anaphylactic reaction to a vaccine
Resources bull Section 11 in the MnVFC Policies and Procedures Manual bull IAC protocols Child and Teens (wwwimmunizeorgcatgdp3082apdf) and Adults (wwwimmunize orgcatgdp3082pdf)
Page 30 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
i
i i i - li i i i i i l
Section 4 Storage amp Handling Per Unit The goal of this section is to assess vaccine storage
2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet practices in each unit at the site MnVFC PIN ___________________
The 2017 MnVFC Storage amp Handling Per Unit Answer Sheet is a worksheet to document the answers to the questions in this section for each unit (combination or stand-alone) Fill in the answers to the questions in Section 4 on the answer sheet not in the questionnaire
The answer sheet has an abbreviated form of each question If you need further information on that question refer back to the full questionnaire Also if you find an area where the site is not meeting the requirements you will need to go back to that question on the 2017 MnVFC Site Visit Questionnaire to complete ldquoActions if Non- compliantrdquo section including the root cause analysis and follow-up sections If there is a problem in more than one unit make a note on the questionnaire which unit you are referring to in the Notes section
Important You must fully assess any unit that may be used to store VFC vaccines even if there are no VFC vaccines there on the day of the visit If there are no vaccines and the site is not documenting twice a day temperatures discuss the need to ensure the unit is maintaining stable temperatures by monitoring for one week before placing vaccines in the unit
Quest on number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
for the freezer and e co umn
Temperature Monitoring Dev refr gerator f the un
ce Quest ons Quest ons 4 3 4 7 must be answered separate y t s a combo Be sure to document responses n the appropr at
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
44D Data downloaded and reviewed routinely (eg weekly)
Yes No [O]
Yes No [O]
45A Certificate of Calibration Testing Yes No [X]
Yes No [X]
45B Date of calibration
45C Date certificate expires [X] Follow-up is required if expired [X] Follow-up is required if expired
45D Certificate contains all necessary items
Yes No [X]
Yes No [X]
46 Probe properly placed Yes No [X]
Yes No [X]
47A Two temperature readings per day
Yes No [X]
Yes No [X]
47B Time date and name (or initials) for each reading
Yes No [X]
Yes No [X]
47C Current temperature and minmax temperatures (if
Current ________deg Minimum ________deg Maximum _deg
Current ________deg Minimum ________deg Maximum _deg
Sections 5 and 6 contain questions about storage and handling site wide and inventory It is helpful to keep those questions in mind as you assess the individual storage units Think about dorm-style units expired vaccine vaccine supply room for vaccine stocking all the recommended vaccines and separation of stock if appropriate
NOTE The sections that follow require reviewers to validate responses by looking at vaccine storage units temperaturemonitoring equipment and the vaccine inventory inside a unit bull For section 4 use a separate Storage amp Handling Per Unit Answer Sheet for each unit to document the findings (combination
units using both sections can be documented on the same answer sheet) bull When an unmet requirement is identified return to this questionnaire to complete the ldquoActions if Non-compliantrdquo section for
that question bull After you complete one answer sheet for each unit return to the questionnaire to complete sections 5 and 6 using information
you gathered while assessing the units The questions in sections 5 and 6 (Storage amp Handling Site-Wide and Inventory) are notunit-specific but do require that the response be based on a thorough assessment of all the providersrsquo units
4 Storage amp Handling Per Unit
Description On the Storage amp Handling Per Unit Answer Sheet place a name that will allow you or someone else from your program to easily identify this unit in the event of follow-up We recommend using Brand + Location(example Samsung - Room 123) Save each Storage amp Handling Per Unit Answer Sheet with the Brand + Location in the file name
(example SamsungRoom123doc)
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The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 41
4 Storage amp Handling Per Unit Storage Unit Build amp Use
Question 41 Below select the build and use of the vaccine storage unit you are assessing
Note to Reviewer Dorm-style units Do not add dorm-style units here Dorm-style units will be addressed in section 5 Units storing only private stock You must review these storage units even if they contain only private stockat the time of the visit because that vaccine could be administered to VFC patients
A What type of unit is this A Stand-alone B Combination
B Select use if stand-alone A Freezer B Refrigerator
Select use if combination A Use both sections to store vaccine B Use freezer section only to store vaccine C Use refrigerator section only to store vaccine
Goal of this question Identify the unit you are evaluating The description asks you to create a unique name for this unit so that you will be able to identify the same unit in future site visits Put this description on the top of the answer sheet (ie make and location)
Helpful information bull A stand-alone unit is either a refrigerator or a freezer It does not have both sections in the unit bull If there is a combination unit note if the site uses both the refrigerator and freezer or only one section of the unit to store vaccines CDC does not recommend the use of either section or the freezer section only of combination household units
bull If your site utilizes the separate stock method of vaccine management you must review storage units even if they contain only private stock at the time of the visit because there is a chance that those vaccines could be administered (borrowed) to VFC-eligible patients
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-
Question 424 Storage amp Handling Per Unit CDC Recommended Storage Units
Question 42 Below document the grade of the vaccine storage unit you are assessing
Note to Reviewer Pharmaceutical Also called ldquopurpose-builtrdquo these units are designed by the manufacturer specifically tostore vaccines or other biological materials Commercial Although usually intended to store food and beverages commercial units are often larger and more powerful than the household units found in most homes Though these units are intended to meet thehigher demands of larger facilities these units are not specifically built for the storage of biologicalmaterials Household (non-commercialdomestic) These units are usually smaller than commercial units and areintended for use in small offices and in homes ndash typically for food storage However just like commercialunits they are not designed specifically for the storage of biological materials Such units are usually available in common home supply stores
Answers (Choose one)
Select grade A Pharmaceutical B CommercialHousehold
[O] CDC does not recommend the use of both sections or the freezer section only of combination commercialhousehold units
Review CDC Recommendation
CDC recommends the following vaccine storage unit types (in order of preference) pharmaceutical grade stand-alone orcombination units (preferred) householdcommercial stand-alone units householdcommercial combination units using therefrigerator section only
Goal of this question Assess the grade and type of each storage unit bull Pharmaceutical grade units may be stand-alone or combination units that are often metal may have glass in the door for viewing inside often have an external digital temperature display and are manufactured by medical companies
bull Commercial or household units often look like your kitchen appliance have vegetablemeat drawers in the unit and are manufactured by household appliance companies
bull Occasionally you might find a medical grade unit which is usually a commercialhousehold unit with a lock and 3-prong plug These are still considered household units because of their ability to maintain proper temperatures and air flow Studies show that household stand-alone units are better able to maintain consistent temperatures than their combination counterparts Combination household units used to store vaccine in both sections of the unit is no longer recommended and may be prohibited in the future Combination household storage units that are having difficulty maintaining a cold enough freezer temperature and a warm enough refrigerator temperature should be replaced or a separate stand-alone freezer should be purchased
For frozen vaccines the most cost effective solution is for the site to purchase a small stand-alone freezer The site may need time to budget for a stand-alone storage unit
Resources bull Replacing Combination Household Units Tip Sheet on IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml)
IPI Advisor Manual | February 2017 Page 33
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 434 Storage amp Handling Per Unit Temperature Monitoring Device in the Unit
Question 43 Determine whether there is a temperature monitoring device in this section of the storage unit andanswer the questions
A Is there a temperature monitoring device in this section of thestorage unit
Yes No [X] (If no skip to question 47)
B Who is responsible for supplying the temperature monitoring device in this section of the storage unit Provider
Review CDC Requirement
Certificates of calibration testing provide confidence that the temperature monitoring device is measuring temperaturesaccurately All units storing VFC vaccines must have a calibrated temperature monitoring device with a current and valid certificateof calibration testing All certificates must contain modeldevice name or number serial number date of calibration testing (report or issue date) and Instrument Passed testingInstrument in Tolerance (Recommended uncertainty = +-05ordm C (+-1ordm F))
Goal of this question Assess whether there is a temperature monitoring device in the unit If the unit is not being monitored at all call MDH at 651-201-5522 for guidance
Helpful information bull This question does not ask whether the temperature monitoring device is working or the characteristics of the device These issues will be addressed later in the questionnaire
bull For part B the provider is always responsible for supplying the temperature monitoring device Even if their thermometer or data logger was originally from MDH it is their responsibility to ensure it is functional and calibrated
Resources bull Section 8 in the MnVFC Policies and Procedures Manual
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-
Question 444 Storage amp Handling Per Unit CDC Recommended Temperature Monitoring Device
Question 44 Assess the temperature monitoring device in this section of the storage unit to answer the questionsbelow
A Is the temperature monitoring device a continuous monitoring and recordingdevice (eg data logger)
Yes No [O] (Skip D)
B Does the temperature monitoring device have a probe in buffered material Yes No [O]
C Does the temperature monitoring device have a digital display that can beeasily read from the outside of this unit
Yes No [O]
D Is data downloaded and reviewed routinely Yes No [O]
Review CDC Recommendation
As of Jan 1 2018 all VFC providers must use continuous temperature monitoring devices (eg data loggers) to monitor vaccinesthat will be administered to VFC-eligible children Routine review and accessibility of temperature data is critical for determining whether vaccine has been properly stored and for assessing usability of vaccine that was involved in a temperature excursion Tomeet VFC Program requirements the device must also be equipped with bull A temperature probe bull An active temperature display that can be easily read from the outside of the unit bull The capacity for continuous monitoring and recording capabilities where the data can be routinely downloaded
The following are additional recommended features for these devices bull Alarm for out-of-range temperatures bull Current minimum and maximum temperatures display bull Low battery indicator bull Accuracy of +- 1degF (05degC) bull Memory storage of at least 4000 readings bull User programmable logging interval (or reading rate) recommended at a maximum time interval of every 30 minutes bull Use of a probe that best reflects the temperature of the vaccine (such as a buffered probe)
Goal of this question Assess the temperature monitoring device in the storage unit Note that these are all recommendations not requirements at this time
This is a great teaching opportunity for sites who do not currently have a continuous temperature monitoring device Beginning Jan 1 2018 all units that store MnVFC vaccine will be required to have a continuous temperature monitoring device (ie a data logger or a continuous temperature monitoring system) Unlike a minmax thermometer a continuous temperature monitoring device provides detailed information on all temperatures recorded at pre-set intervals For excursions it can provide information on when a temperature went out-of-range for how long and what the temperatures were This is essential information that vaccine manufacturers need to know to assess the viability of the vaccine following an excursion
Helpful information bull Sites are required to monitor and record temperatures twice daily however temperature excursions can easily occur in the 12 hours or longer between readings Continuous temperature monitoring can help manufacturers determine vaccine viability
bull Continue to encourage sites to document and evaluate minimum and maximum temperatures the storage unit reached since the last reading and respond appropriately to out-of-range temperatures
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The 2017 MnVFC Site Visit Paperwork Chapter 4
bull It is recommended that sites download and review data weekly Discuss with sites that reviewing temperature monitoring device data also includes responding appropriately if they identify out-of-range temps
bull There is sometimes confusion about the difference between a data logger and a continuous temperature monitoring system Here are some differences
Data Loggers Continuous Monitoring Systems Have an external display similar to thermometers May or may not have an external display Have a detachable probe Probe is usually attached to transmitter Need to be plugged into the computer or cradle to download information on a regular schedule
Wirelessly sends data to computer system
Create a file of data that needs to be saved on the computer
Data is stored within the system not a separate file
Doesnrsquot allow documentation of twice a day temperature checks in the file
May allow documentation of twice a day temperature checks within the system
More about the 2018 requirement for a continuous temperature monitoring device
Required Features bull The continuous temperature monitoring device must have Continuous monitoring and recording capabilities to track and record temperatures over time The capacity to routinely download temperature data to a computer (recommended at least weekly) or wirelessly transmit data Detachable probe in a bottle filled with a thermal buffer (eg bio-safe glycol) if the data logger needs to be detached in order to download data Active temperature display
Recommended Features bull MnVFC recommends continuous temperature monitoring devices with Alarm for out-of-range temperatures Accuracy within +-1degF (+- 05degC) Low battery indicator Display of current minimum and maximum temperatures Memory storage of at least 4000 readings User programmable logging intervals (eg the user can set how often the device records the temperature)
Note that these are all currently recommendations not requirements yet
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
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The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 45
Goal of this question Ensure the temperature monitoring device is properly calibrated The certificate of calibration testing means that the device has been tested and it is accurately measuring temperatures within established testing limits The certificate of calibration ensures that the device meets all the required components
Helpful information bull The provider is always responsible for having a current certificate of calibration (or copy) on-site
bull To be considered ldquovalidrdquo a certificate of calibration must contain these required elements Modeldevice name or number Serial number
4 Storage amp Handling Per Unit Certificate of Calibration Testing
Review CDC Requirement
Certificates of calibration testing provide confidence that the temperature monitoring device is measuring temperaturesaccurately All units storing VFC vaccines must have a calibrated temperature monitoring device with a current and valid certificateof calibration testing All certificates must contain modeldevice name or number serial number date of calibration testing (report or issue date) and Instrument Passed testingInstrument in Tolerance (Recommended uncertainty = +-05ordm C (+-1ordm F))
Question 45
Note to Reviewer
A
B
C
D
E
Review the certificate of calibration testing for the temperature monitoring device in this section of the storage unit and answer the questions below
bull How to determine certificate of calibration testing expiration date 1) Identify the certificate issuecalibration date 2) Apply the Immunization Program-required frequency for calibration testing Example If the
issuecalibration date is 12312013 and Immunization Program policy requires testing every twoyears the expiration date is 12312015
bull Certificates must include all of the below bull ModelDevice Name or Number bull Serial Number bull Date of Calibration Testing (Report or Issue Date) bull Instrument Passed testing (Instrument in Tolerance)
Is there a certificate of calibration testing for the temperature monitoring Yes device in this section of the storage unit No [X]
What is the date of calibration for the temperature monitoring device in this section of the storage unit
What is the certificatersquos date of expiration based on ImmunizationProgram policy (See note to reviewer to determine expiration date) [X] Follow-up is required if
certificate is expired
Does the certificate contain all the necessary items listed in the Note to Yes Reviewer No [X]
Who is responsible for supplying the current and valid certificate of Provider calibration for this temperature monitoring device
Date of calibration testing (report or issue date) Note If there is no expiration date the certificate expires 2 years from the date of calibration Whether the instrument passed or failed testing (or instrument in tolerancenot in tolerance)
bull Recommended element Documented uncertainty of +- 1degF [05degC]
If these elements are present the certificate is considered valid If the certificate contains information about the recommended element or the entity that issued the certificate that is helpful but not required
To determine if a certificate of calibration testing was issued by an appropriate entity check to see if the certificate indicates one or more of these items (this is the wording used to help sites evaluate if their calibration is accurate but is not required on the certificate itself to be considered valid)
bull Conforms to ISO 17025 bull Performed by an ILACMRA Signatory body accredited laboratory You can review this list of the ILAC MRA and Signatories (httpilacorgilac-mra-and-signatories)
bull Traceable to the standards maintained by NIST bull Meets specifications and testing requirements for the American Society for Testing and Materials (ASTM) Standard E2877 tolerance Class F (le 05 degC) or better
bull Includes reference to another acceptable accuracy validation method such as comparison to other traceable reference standards or tests at thermometric fixed points
Note CDC recommends that certifications be issued for the entire monitoring unit (detachable probe data logger etc) and not individual certificates for each component
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The 2017 MnVFC Site Visit Paperwork Chapter 4
For 45 E the provider is always responsible for supplying the current and valid certificate of calibration for a temperature monitoring device
bull Tip If the temperature monitoring device has a sticker on the back with the calibration date the site can usually call the company who calibrated the device and get a copy of the certificate if they donrsquot have one
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 46 4 Storage amp Handling Per Unit Probe Placement
Question 46 Is the probe properly placed in this section of the storage unit
Note to Reviewer ldquoProperlyrdquo means that the probe in a commercial or household unit is placed in a central area of the unitdirectly with the vaccines Probes should not be placed in the doors near or against the walls close to vents or on the floor of the unit The only allowable exemption related to this requirement is for providerswho have pharmaceutical storage units (built for vaccine storage) that have either (1) a built-intemperature monitoring device OR (2) a dedicated port for the probe that dictates the placement of theprobe
Answers (Choose one)
Yes No [X]
Review CDC Requirement
The probe must be placed in a central area of the section of the storage unit directly with the vaccines in order to properly measurevaccine temperature The probe should not be placed in the door near or against the walls close to vents or on the floor of theunit For pharmaceutical units with a built-in temperature monitoring device or a dedicated port for a probe that is not in thecenter of the section of the storage unit consult your Immunization Program for guidance on placement
Goal of this question Make sure the temperature monitoring device is in the best location to accurately measure the temperature of the vaccines stored in the unit
Helpful information bull The probe of the temperature monitoring device should be placed directly with the vaccines in the middle of the unit The ONLY allowable exception is for pharmaceutical storage units that have either a built-in thermometer or a dedicated port for the probe that indicates placement of the probe
bull Temperatures can vary within the unit especially household units bull Call MDH at 651-201-5522 if you have questions
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Guide (wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml)
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Question 474 Storage amp Handling Per Unit Temperature Documentation
Question 47 Review the temperature documentation over the past three months for this section of the storage unit todetermine whether the provider has a process in place for properly documenting temperatures twice aday Answer the questions below
A Are there two temperature readings recorded for this section of the storage unit per day
Yes No [X]
B Is there a time date and name (or initials) recorded for each reading Yes No [X]
C What is the current temperature and minmax temperatures (if available) inthis section of the storage unit Use the reviewerrsquos thermometer if the providerrsquos temperature monitoringdevice does not have a current valid certificate of calibration testing or the probe is not properly placed in this section of the storage unit
Current Temperature Minimum Temperature Maximum Temperature Fahrenheit Celsius
D Based on your review of the providerrsquos recent temperature documentationincluding the current temperature is this section of the storage unitmaintaining appropriate temperatures
Yes No [X] Not enough information [X]
Review CDC Requirement
Vaccines must be stored under appropriate temperatures as described in the package inserts at all times Acceptable temperature ranges vary by vaccine type and the range is 36deg F and 46deg F (2deg C and 8deg C) and for frozen vaccines the range is -58deg F and +5deg F (shy50deg C and -15deg C) Exposure to temperatures outside of those included in the package inserts could affect vaccine viability andultimately could leave children unprotected against vaccine-preventable diseases In order to maintain awareness of storage unittemperatures and ensure that vaccines are being stored at appropriate temperatures at all times VFC providers are required to monitor and document temperatures for all vaccine storage units at least twice a day Temperature documentation must contain (1) at least two temperature readings per day (2) the time and date of each reading and (3) the name (or initials) of the personwho assessed and recorded the readings CDC also recommends that VFC providers record the minimum and maximumtemperatures of each unit once each workday (preferably in the morning)
Goal of this question Ensure the temperature is being monitored twice daily is within the required range and documented correctly Use your thermometer to check the temperature if the sitersquos temperature monitoring devicersquos probe is not properly placed or there is not a current certificate of calibration Place your thermometer in the unit at the beginning of the visit to allow sufficient time to reach an accurate temperature The purpose of using your thermometer is to ensure the vaccine is being stored at the proper temperature not to ldquovalidaterdquo their reading
Question 47 D is an assessment question based on information you have learned during your visit You might answer ldquonot enough informationrdquo if the unit is new and they donrsquot have at least three months of data or if the unit is only used as overflow and they are inconsistent with temperature monitoring Mark ldquoNordquo if you have reason to believe the storage unit is not maintaining temperatures properly
Helpful information bull All sites must document temperatures twice a day every day the site is open even if they have a data logger or continuous monitoring system
bull Sites can document the information electronically with some continuous monitoring systems as long as it can show what the current temp is the date time and initials of the person checking ndash this needs to be someone at the site ndash not checking remotely or centrally for a large site or system The site must be able to produce these records during their site visit Reviewing these files can be a challenge due to large volumes and lots of paper
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Temperature Logs on Managing Vaccine (wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml)
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The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 484 Storage amp Handling Per Unit Temperature Excursions
Question 48 In the event that a temperature excursion(s) occurred in this unit within the last three months requestand review documentation of actions taken to determine whether the provider has a process for properlyaddressing excursions Answer the questions below
A Were vaccines in this unit exposed to out-of-range temperatures in the lastthree months (including today)
Yes No (If no skip to question 49)
B Did the provider quarantine and label vaccines as ldquoDo not userdquo Yes No [X]
C Did the provider place vaccine in a unit where it can be stored under properconditions if applicable
Yes No [X]
D Did the provider contact the Immunization Program to report theexcursion
Yes No [X]
E Was the manufacturer contacted for documentation supporting theusability of the vaccine
Yes No [X]
Review CDC Requirement
The provider must document all excursions and actions taken including the following (1) Quarantine and label vaccines as ldquoDO NOTUSErdquo (2) Place vaccines in a unit where they can be stored under proper conditions (3) Contact the Immunization Program to report an excursion and (4) Contact the vaccine manufacturer to obtain documentation supporting the usability of the vaccine
Goal of this question Address any out-of-range temperatures (temperature excursions) identified in reviewing the last three months of temperature logs or during the site visit If there were any out-of-range temperatures did the site respond appropriately to the situation This is a great opportunity to discuss what to do in the event of an excursion The Clinicians Storage and Handling Mishap Checklist is in the IPI Site Visit information folder and is a good review of the process
Helpful information bull Sites need to know that an excursion does not automatically mean that exposed vaccines are non-viable or unusable Exposed vaccines must be quarantined (marked ldquoDo Not Userdquo) and stored under proper conditions until they have received information from vaccine manufacturers regarding the viability of the vaccine
bull Sites must inform MDH when an excursion occurs
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Clinicians Storage and Handling Mishap Checklist (wwwhealthstatemnusdivsidepcimmunize ipivaxchklstpdf)
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Question 49
Goal of this question Ensure proper placement of vaccines in the storage unit
Note These are all recommendations (best practices) not requirements
Helpful information bull Store vaccine in the middle of the compartment two to three inches away from the coils walls floor and cold air vent The temperature near the floor and walls of the unit differs from that in the middle of the compartment and the cold air vent can freeze refrigerated vaccines
4 Storage amp Handling Per Unit Vaccine Placement
Question 49 Look inside the unit to answer the questions below
A Are vaccines placed in the middle of the unit with space between vaccinesand the sideback of the unit to allow cold air to circulate
Yes No [O]
B Are vaccines stored in their original packages Yes No [O]
C Are there water bottles (for refrigerators) or frozen water bottles (forfreezers) in the unit
Yes No [O]
D Are vaccines store in the doors vegetable bins under or near cooling ventsor on the floor of the unit
Yes [O] No
E Is food being stored in the unit Yes [O] No
Review CDC Recommendation
Vaccines should be stored in their original manufacturer (or CDC centralized distributor) packaging They should be placed in the middle of the unit with space between the vaccines and the sideback of the unit to allow cold air to circulate Vaccines SHOULD NOT be stored in the doors vegetable bins or floor of the unit or under or near cooling vents and there should not be any food inthe unit Water bottles (for refrigerators) or frozen water bottles (for freezers) should be placed throughout each storage unit inorder to (1) stabilize or extend temperatures during a power outage and (2) to serve as physical blocks preventing the placementof vaccines in areas of the unit that are at higher risk for temperature excursions (such as in doors vegetable bins floor ornearunder cooling vents)
bull Vaccines should be kept in their original packaging to Protect them from light Help prevent medication errors by making labels easier to read Provide a moisture barrier that serves as insulation in case of an out-of-range temperature power outage door left open or mechanical failure Simplify managing vaccine inventory
bull Store water bottles in the doors on the floor and near the cold air vent in the refrigerator and frozen water bottles in the freezer to help maintain a stable temperature if there is a power failure and when the door is opened frequently Too many water bottles in the door can prevent the door from closing tightly Mark water bottles ldquoDo Not Drinkrdquo
bull Do not store vaccine in the door or drawers of the refrigerator or freezer Vegetable bins and crisper drawers should be removed from refrigerators or used to store other medical supplies or water bottles
bull If vaccine is stored in a household combination refrigeratorfreezer The top shelf should not be used for storing vaccine because the cold air vent blowing from the freezer will freeze vaccine located there If you must use the top shelf of this type of unit place water bottles underneath the cold air vent to prevent vaccine from being stored there It is recommended that only the refrigerator be used for vaccine storage and a separate stand-alone freezer be used to store frozen vaccine
bull Must not store food or beverages in the refrigerator or freezer because frequent opening of doors can lead to temperature variations that may affect vaccine viability There is also a risk of contaminating vaccines
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Guide (wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml) bull Vaccine Storage Tip Sheet on IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml)
IPI Advisor Manual | February 2017 Page 41
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 4104 Storage amp Handling Per Unit Disconnection from Power Source
Question 410 Ask the provider to demonstrate what measures are taken to ensure that vaccine storage units are notaccidentally physically disconnected from the power supply Which of the following describes the measure(s) taken on this unit
Note to Reviewer bull Large hospitals and healthcare systems may not have the ability to demonstrate labels on plugs or circuitbreakers In such cases verify that the practice has a comprehensive policy and standard operatingprocedures in place to prevent the vaccine storage unit from being physically disconnected from thepower supply
bull While back-up generators may ensure power to the overall facility this question ONLY addresses thevaccine storage unit being accidentally disconnected from the power source either through the plug orthe circuit breaker
Answers A ldquoDo not disconnectrdquo labels on the plug (Choose all that B ldquoWarningrdquo label on the circuit breaker box
apply) C Hard-wired (ie built-in) and has a ldquoDo not disconnectrdquo label on thecircuit breaker box D Hospital or large health care system with a comprehensive written policyand standard operating procedures detailing measures taken to preventvaccine storage units from being accidentally disconnected from the powersupply E No acceptable measures for preventing accidental disconnection frompower supply [X]
[X] The response is non-compliant if only A only B or E is selected
Review CDC Requirement
VFC providers must take steps to protect the power source for all vaccine storage equipment by means of having clear warninglabels on both the plug and the circuit breaker associated with all vaccine storage units Large hospitals and healthcare systems canmeet this requirement by demonstrating that they have comprehensive policies and standard operating procedures to preventvaccine storage units from being physically disconnected from the power supply
Goal of this question Decrease the chance that a vaccine storage unit will be accidently unplugged or power will be turned off while vaccine is in the unit This question addresses only what measures the site has taken to ensure the storage unit is not physically disconnected from its power source
If the site uses labels on the plugs and circuit breakers perform a visual inspection to assess whether the way the stickers are positioned make it clear and obvious to anyone that these units are not to be disconnected
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Do Not Unplug and Warning stickers are included in the folder or available to order on the For
Professionals Order Form (wwwhealthstatemnusdivsidepcimmunizeordermathtml)
Note Once you have completed the 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet for each unit return to the questionnaire to complete sections 5 and 6
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The 2017 MnVFC Site Visit Paperwork Chapter 4
-
- -
Section 5 Storage amp Handling Site-Wide Question 51
5 Storage amp Handling Site Wide Discussion of Cost amp Quantity of Vaccine
Question 51 Have a discussion with the provider about the cost and quantity of VFC vaccines they are responsible for annually Address the points listed in the note to reviewer below
Note to Reviewer bull Vaccine Shipped (Required) Share the cost of VFC vaccines shipped to the provider in the last calendaryear to make sure the provider understands the contribution made by the VFC Program to their practiceFor new providers who do not have ldquocalendar yearrdquo data share either the actual cost of their currentinventory or use the cost of 10 VFC doses of each of the ACIP-recommended vaccines (approximately $7000) to help estimate their annual cost
bull Storage amp Handling (Required) Make sure the provider understands the cost of vaccines for which they are responsible when they make decisions about purchasing recommended vaccine storage and temperature monitoring equipment
Answer I have discussed with the provider the cost and quantity of vaccines ordered in the previous calendar year
Goal of this question Inform sites of the quantity and value of vaccines that they receive as part of the MnVFC program Providers often donrsquot realize the value of the vaccine in their unit This information is included on your clinic list and on the one page site-specific information
Helpful information bull This discussion must occur and the box on the questionnaire must be checked bull If there isnrsquot actual vaccine value information available tell the site that one vaccine order that includes a box of each of the ACIP recommended vaccines costs approximately $7000
bull MDH may not have specific information for individual sites if they receive vaccine from a central warehouse or pharmacy For those sites MDH will give you numbers for the whole system so you can discuss system wide data as appropriate If individual site information is also included it is usually just varicella-containing vaccines that must be shipped directly to the site
Question 52
5 Storage amp Handling Site Wide Dorm Style Units
Question 52 Determine whether the provider has any dorm-style units on site and answer the questions below
Note to Reviewer A dormitory-style refrigerator is a unit that has both refrigerator and freezer compartments behind a singleexterior door Dorm-style units also have an evaporator plate (cooling coil) which is usually located insidean icemaker compartment (freezer) within the refrigerator
A Does the provider have any dorm-style units that are used at any time tostore vaccines
Yes [X] No (Skip to question 53)
B Does the provider have sufficient space in existing compliant vaccinestorage units to store all vaccines without use of the dorm-style unit at any time
Yes No [X]
Review CDC Requirement
Dorm- and bar-style units are prohibited for vaccine storage Vaccines stored in dorm-style units are considered non-viable and must be returned to the centralized distributor CDC recommends the following vaccine storage unit types (in order of preference)pharmaceutical grade stand-alone or combination units (preferred) householdcommercial stand-alone unitshouseholdcommercial combination units using the refrigerator section only
Goal of this question Ensure no vaccine is stored in dorm-style units even for short periods of time Encourage them to label any units ldquoNo Vaccine Storage Allowedrdquo Vaccine stored in these units is considered non-viable If a site is using a dorm-style unit call the MnVFC program (651-201-5522)
Resource Section 8 in the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 43
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-
Question 535 Storage amp Handling Site Wide Storage Unit Space Availability
Question 53 Does the provider have sufficient room across storage units to store current stock as well as anyadditional stock acquired during peak season without overcrowding
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have sufficient storage space to accommodate vaccine stock at the busiest time of year without overcrowding
Goal of this question Ensure that sites have sufficient space in their units to maintain vaccines at the busiest time of year Overcrowding of vaccine limits air circulation and affects the unitrsquos ability to maintain stable temperatures
Helpful information bull Look for signs of overcrowding such as vaccines that are pushed up against the wall bins that are overflowing or storage units that are full during non-peak seasons
Discuss immediate actions if the unit is overcrowded Move some of their vaccines order less vaccine more frequently (once per month preferably) andor purchase another storage unit for overflow
Resource bull Section 8 MnVFC Policy and Procedure Manual
Page 44 IPI Advisor Manual | February 2017
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-
Question 545 Storage amp Handling Site Wide Expired Vaccines
Question 54 Look in each unit Are there expired vaccines in any of the vaccine storage units at this site
Answers (Choose one)
Yes [X] No
Review CDC Requirement
Vaccines should be rotated weekly and when a new shipment comes in so that longer-dated vaccines are stored behind shorter-dated vaccines If vaccines expire they can no longer be stored in the same storage unit with viable vaccines They must be placedin a container or bag clearly labeled ldquoDo not userdquo and separated from viable vaccines to prevent inadvertent use Expired vaccinemust be returned to the centralized distributor within six months of expiration
Goal of this question Ensure there is no expired vaccine in any storage unit
Helpful information bull Sites can prevent their stock from expiring by rotating vaccines every week andor when a new shipment arrives Longer-dated vaccines are stored towards the back of the unit and shorter-dated vaccines are up front
bull Pay attention to vaccines that expire within the next three months Consider transferring vaccine that will expire soon to another MnVFC-enrolled site that will use the vaccine preferably a site close by It is the transferring sitersquos responsibility to arrange the transfer of the vaccine Be sure to complete the MDH Vaccine Transfer Record form and send it to MDH If they are having difficulty finding a location to accept vaccine contact MDH
bull This is a great opportunity to educate sites about the MDH Nonviable Vaccine Form and the process for returning vaccine The VFC program does get some credit for taxes and fees on vaccine that is returned to the distribution center
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MDH Nonviable Vaccine Form and MDH Vaccine Transfer Record on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfcformshtml)
IPI Advisor Manual | February 2017 Page 45
The 2017 MnVFC Site Visit Paperwork Chapter 4
- -
-
Question 555 Storage amp Handling Site Wide Back up Thermometer
Question 55 Does the provider have a readily available back-up thermometer with a current and valid certificate ofcalibration testing
Note to Reviewer ldquoReadily availablerdquo means that the thermometer is available to perform twice-a-day monitoring for a unit asrequired CDC recommends that the back-up thermometer be maintained on site
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have a readily available back-up thermometer with a current and valid certificate of calibration testing Toprevent the certificates of calibration testing of the primary and back-up thermometers from expiring at the same time the date of calibration testing (or issue date) of the back-up thermometer should be different from the date of calibration testing (or issue date) of the primary thermometer As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meetsVFC program requirements
Goal of this question Ensure sites have one calibrated back-up thermometer onsite that is readily available in the event that the temperature monitoring device in unit fails transportation of vaccine is needed or there are other unexpected circumstances
Helpful information bull As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meets VFC Program requirements
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 56 5 Storage amp Handling Site Wide Preparation of Vaccine
Question 56 When does this provider prepare vaccine for administration to the patient
Note to Reviewer For mass vaccination clinics if one type of vaccine is offered providers may pre-draw up to 10 doses Ifusing pre-filled syringes pre-drawing also means activating the syringe by removing the needle guard orattaching a needle
Answers (Choose all that
apply)
Prepare dose immediately before administration Pre-draw doses for upcoming patients (in a regular clinicpractice) [O] Pre-draw up to 10 doses (in a mass-vaccination clinic) Pre-draw more than 10 doses (in a mass-vaccination clinic) [O] Other [O]
Review CDC Recommendation
CDC recommends preparing vaccines immediately prior to administration in order to assure viability of vaccine and prevent vaccinewastage Vaccines that are not administered immediately are at risk of exposure to temperatures outside of the required rangewhich can affect vaccine viability and ultimately can leave children unprotected against vaccine-preventable diseases
Goal of this question Discuss proper timing and preparation of vaccine(s) for administration These are recommendations not requirements
Helpful information bull Educate staff on the importance of preparing vaccine immediately before administration Pre-drawing of vaccines may lead to concerns related to vaccine viability potency sterility and wastage
Page 46 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 6 Inventory Question 61
6 Inventory Inventory Comparison
Question 61 Visually inspect storage units to determine if existing supply of vaccines proportionately mirrorspopulations served Choose the most accurate statement below
Note to Reviewer bull CDC recommends that providers maintain a four-week supply of inventory bull For this question do not take into account vaccine types that the provider does not order Here simply
make sure that overall the vaccines in the providerrsquos storage units are available in sufficient amounts toserve their patient population
Answers (Choose one)
The current vaccine inventory proportionately reflects the populations identified Only public stock is insufficient [X] Only private stock is insufficient [X] Both public and private stock are insufficient [X] Site uses the replacement method but does not appear to have enough vaccine for their population [X] Other [X]
Review CDC Requirement
VFC providers must order and stock routine vaccines in accordance with their patient population in order to prevent missedvaccination opportunities Having sufficient amounts of all stocks prevents the inadvertent use of VFC vaccines for non-VFC-eligiblepatients and vice versa
Goal of this question Assess whether the site is ordering appropriate quantities of vaccine for the population they serve at their site
Helpful information bull If the site sees 30 percent private-pay patients and 70 percent VFC the stock in their storage units should reflect that proportion If you donrsquot know you can ask the site about their population
bull This is meant to be a general assessment so in a big site if they have only a small amount of vaccine that may indicate an issue with vaccine management
bull CDC recommends smaller more frequent orders (ie monthly) rather than large orders to minimize the amount of vaccine loss if an incident occurs during shipment or in the storage unit Sites should not order more frequently than once a month
bull Sites using the replacement method will only have one stock but it should appear to be large enough for their population
bull Only assess the vaccine types that the site currently stocks in their unit We know there are sites that do not offer all ACIP-recommended vaccines for various reasons That issue will be addressed in question 62
IPI Advisor Manual | February 2017 Page 47
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 626 Inventory ACIP Recommended Vaccines
Question 62 Review providerrsquos current inventory to answer the questions below
A Does the provider offer all routine ACIP-recommendedvaccines for their patient population
Yes (Skip to question C) No [X] Offers all except varicella because direct ship ofvaccine is unavailable from manufacturer
B Which routine vaccines are NOT being offered DTaP Hepatitis A Hepatitis B HIB HPV Influenza Meningococcal
MMR Pneumococcal Polio Rotavirus TdapTd Varicella
C According to Immunization Program Policy does theprovider make accessible all non-routine ACIP-recommended vaccines for those VFC patients whomeet the criteria for receiving them
Yes (Skip to question 63) No [X]
D Which non-routine vaccines are NOT being offered Pneumococcal polysaccharide vaccine (PPSV23) Meningococcal Group B (MenB) Other
Review CDC Requirement
VFC providers agree to comply with immunization schedules dosages and contraindications that are established by the Advisory Committee on Immunization Practices (ACIP) for the vaccines identified and agreed upon in the Provider Agreement UNLESS bull In the VFC providers medical judgment and in accordance with accepted medical practice the VFC provider deems such
compliance to be medically inappropriate for the child bull The particular requirements contradict state law including laws pertaining to religious and other exemptions The VFC program entitles children to the following vaccines DTaP Hepatitis A Hepatitis B HIB HPV Influenza MeningococcalMMR Pneumococcal Polio Rotavirus TdapTd and Varicella VFC providers are also required to ensure that VFC-eligible children have access to non-routine vaccines as needed
Goal of this question Assess if the site is offering all the ACIP-recommended vaccines for the population they serve and these vaccines are in stock on the day of the visit It is important that every MnVFC-eligible child that comes to a providerrsquos office for an immunization is vaccinated
Helpful information bull The Advisory Committee on Immunization Practices (ACIP) is a group of medical and public health experts that develops recommendations on how to use vaccines to control diseases in the United States
bull Specialty providers are not required to offer all routine vaccines but should provide the vaccines appropriate for their population
bull If the site does not offer all routine ACIP-recommended vaccines appropriate for their population check the ldquoNordquo box in Part A then check the appropriate box(es) in Part B for any vaccines not offered Please contact MDH as this situation offers us the opportunity to provide education to the site
bull For non-routine vaccines they must either be in stock or the site must have an alternative protocol in the routine management plan that ensures these children have access when applicable
Resources bull IAC Diseases and Vaccines (wwwimmunizeorgvaccines) bull CDC Advisory Committee on Immunization Practices (ACIP) (wwwcdcgovvaccinesacipindexhtml)
Page 48 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 636 Inventory Separation of Stock
Question 63 Observe how the provider differentiates stock in each storage unit to answer the questions below
A Is it clear which vaccines belong to public stock andwhich belong to private stock
Yes No [X] Not applicable replacement site
B Is it clear which vaccines belong to VFC stock andwhich belong to UUAV stock
Yes No [X] Not applicable replacement site Not applicable not UUAV-enrolled site
Review CDC Requirement
In order to ensure that VFC vaccines are only administered to VFC-eligible children VFC providers that serve both VFC and non-VFCshyeligible children must maintain their vaccine inventories in such a way that they can clearly differentiate public stock from privatestock as well as VFC from other public stock
Goal of this question Assess whether the site can distinguish between MnVFC vaccine and private vaccine If they participate in the Uninsured and Underinsured Adult Vaccine (UUAV) program they should also be able to distinguish between MnVFC stock and UUAV stock Some sites use labels bins boxes etc to differentiate their stock If it is not clear how the site differentiates their stock discuss vaccine management with the staff For follow-up call MDH to discuss doing a follow-up site visit
Sites using the replacement method will not have separate stocksmdashthis is an approved alternative method for keeping track of vaccine
Resource bull Section 10 of the MnVFC Policy and Procedure Manual
IPI Advisor Manual | February 2017 Page 49
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
MnVFC Site Visit Storage and Handling Per Unit Answer Sheet 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet MnVFC PIN ___________________
Question number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
Temperature Monitoring Device Questions Questions 43 47 must be answered separately for the freezer and refrigerator if the unit is a combo Be sure to document responses in the appropriate column
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
All the questions on the Site Visit Storage amp Handling Per Unit Answer Sheet have been discussed previously in section 4 of this manual Use this sheet to record information about all the units at the site visit You will need one sheet for each unit If it is a combination unit (either pharmaceutical or household) you can record both sections on one sheet If they have stand-alone units use one sheet for each unit Do not enter the answers to the questions in section 4 of the questionnaire
If you need more information about any of the questions refer back to the main questionnairemdashthe complete question additional guidance including notes to the reviewer and the CDC requirements are there Also if the site is not meeting the requirement you will go back to the questionnaire to complete the ldquoActions if Non-compliantrdquo section including the root cause analysis and follow-up sections
When you have completed the assessment of all the storage units remember to go back to the questionnaire to complete sections 5 and 6
Page 50 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
ndash
ndash
MnVFC Provider Follow-up PlanThe goal of the Provider Follow-up Plan is to communicate with the site all of the VFC requirements any unmet requirements found during your site visit and the timeline for completing the required action The left hand column is a box to check for ldquoUnmetrdquo requirements
Helpful information bull The form can be used to review what the site is doing well and what they need to work on
bull For requirements that have specific documentation that needs to be sent to you use the notes section
2017 MnVFC Provider Follow-up Plan Site _______________________________________________ MnVFC PIN ____________ Date of Visit ___________
Thank you for participating in this MnVFC compliance site visit Please review this visit summary including follow-up actions and timelines for completion Unmet MnVFC requirements and recommendations have a checked box next to them The goal of this plan is to support you with successfully implementing the program and improving access to vaccines for VFC-eligible children
Unmet Question VFC Requirements Section 1 Changes to Key Staff
Q12 Change in the Medical Director Immunization Manager Vaccine Coordinator or back-upKey Staff must be communicated to the immunization program by emailing healthmnvfcstatemnus Changes Notes
Q12 Key staff must complete the annual training on VFC program requirements and print theAnnual Training certificate of completion Documentation Required Action
Staff that have not completed the MnVFC online training must complete it and send acopy of the certificate to the reviewer Training can be found on the MnVFC website (wwwhealthstatemnusvfc) Due date 1 month
Notes
Unmet Question VFC Requirements Section 2 Eligibility
Q21 Provider staff must possess a working knowledge of all VFC eligibility criteria and use thoseVFC Eligibility criteria to screen children prior to administering VFC vaccines
Categories Notes
bull This form provides documentation needed for follow-up actions when you send your thank you email
The second to last page of the Provider Follow-up Plan has a summary of the MnVFC program recommendations These are to remind the site about best practices they may want to improve upon even though they are not yet requirements of the program For example you could discuss the recommendation about storage units if they currently have a combination household unit and are using both sections
The last section is for your signature and the person you met with In most sites it will be the immunization manager or vaccine coordinator who signs the form unless the medical director attended the site visit You keep the original copy and the site will need to keep a copy for themselves
To be completed by the site visit reviewer
I acknowledge that a VFC site visit was performed on __________________ (visit date) The follow-up plan which includes a list of all current VFC program requirements and recommendations assessed during the visit and any required follow-up actions was provided at the end of the visit
Site visit reviewer
Phone
Reviewer Signature Date
To be completed by the provider
I acknowledge that our practice took part in the VFC site visit noted above I understand the findings of the visit and any required actions that must be taken by our office in order to meet VFC program requirements
Medical Director (or designee) Name Title
Medical Director (or designee) Signature Date
IPI Advisor Manual | February 2017 Page 51
The 2017 MnVFC Site Visit Paperwork Chapter 4
After the Site Visit Send a thank you email highlighting the unmet requirements documents you need from the site to resolve the issue(s) and the date you need them Make sure to include the link to the Site Visit Survey (httpssurveyvovicicomseashxs=56206EE334CE0B14)
Please refer to Chapter 3 for more information about future follow-up required after the visit including forms and documentation
Resource bull Sample Thank You letter on IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml)
Chapter 5
IPI Advisor Resource List MnVFC Program 651-201-5522
MnVFC wwwhealthstatemnusvfc
bull Separate Stock and Replacement Method Policies and Procedures Manuals bull Online trainings bull MnVFC Announcements sign up to receive them via email bull Ordering MDH vaccine bull MnVFC forms Screening forms Reporting forms Others MDH Nonviable Vaccine Form MDH Vaccine Transfer Record and Vaccine Borrowing Report
bull MnVFC promotional materials bull Immunization Billing Guidance for MnVFC and Immunization Billing Guidance for MnVFC Replacement Sites Immunization Practices Improvement Program (IPI) wwwhealthstatemnusdivsidepcimmunizeipi
bull IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml) bull IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml) IPI Resource Folder Contents (wwwhealthstatemnusdivsidepcimmunizeipiipifolderpdf)
Minnesota Immunization Information Connection (MIIC) wwwhealthstatemnusmiic
bull MIIC regions and regional coordinators
Clinical Practice MDH Immunization Program wwwhealthstatemnusimmunize
Got Your Shots News wwwhealthstatemnusdivsidepcnewslettersgys
MDH Immunization Information for Health Care Providers wwwhealthstatemnusdivsidepcimmunizehcp
bull Got Your Shots A Providers Guide to Immunization in Minnesota bull Vaccine protocols bull Forms for tracking patient immunizations bull Immunization schedules for Health Care Providers Immunization Action Coalition (IAC) wwwimmunizeorg
bull Ask the Experts bull VISs (Vaccine Information Statements and translations) bull Administration screening questions bull Medical management of vaccine reactions bull Order form for Californiarsquos Immunization Technique DVD Best Practices with Infants Children and Adults
Page 52 IPI Advisor Manual| February 2017
IPI Advisor Resource List Chapter 5
CDC ldquoPink Bookrdquo wwwcdcgovvaccinespubspinkbookindexhtml
CDC Advisory Committee on Immunization Practices (ACIP) wwwcdcgovvaccinesacip
CDC Vaccines and Immunizations wwwcdcgovvaccines
VAERS reporting httpvaershhsgovindex
Storage and Handling Got Your Shots Providers Guide ndash Managing Vaccine wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml
MnVFC Guide to Temperature Monitoring Devices wwwhealthstatemnusvfc
MDH Clinicianrsquos Vaccine Mishap Checklist wwwhealthstatemnusdivsidepcimmunizeipivaxchklstpdf
MDH Vaccine Storage Guide wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml
CDC Vaccine Storage and Handling Toolkit wwwcdcgovvaccinesrecsstoragetoolkit
You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Vaccine manufacturer phone numbers wwwcdcgovvaccinespubspinkbookdownloadsappendicesFcontact-info-manufactpdf
IAC Checklist for Safe Vaccine Handling and Storage wwwimmunizeorgcatgdp3035pdf
IAC Donrsquot Be Guilty of These Errors in Vaccine Storage and Handling wwwimmunizeorgcatgdp3036pdf
Additional Resources Print materials from MDH ndash order forms wwwhealthstatemnusdivsidepcimmunizeordermathtml
Vaccine Education Center ndash Childrenrsquos Hospital of Philadelphia wwwchopeduservicevaccine-education-centerhomehtml
California Department of Public Health ndash Interactive training on vaccine administration and storage and handling handout on transporting vaccine and how to package wwwezizorg
IPI Advisor Manual | February 2017 Page 53
IPI Advisor Resource List Chapter 5
CDC vaccine price list wwwcdcgovvaccinesprogramsvfcawardeesvaccine-managementprice-listindexhtml
Vaccine Information Statements (VIS) wwwcdcgovvaccineshcpvisindexhtml
CEU Opportunities CDC Immunization Education and Training wwwcdcgovvaccinesedindexhtml
Immunization You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Page 54 IPI Advisor Manual| February 2017
- Introduction
-
- Welcome to the Immunization Practice Improvement (IPI) Program
- Contact Information
-
- Chapter 1
- Requirements to Participate in the MnVFC Program
- Vaccines for Children Program
- Chapter 2
- Reimbursement for MnVFC Visits
- Types of Visits
- Your MnVFC Clinical CoordinatorPlanner
- New IPI Advisor Training Requirements
- Your Role as an IPI Advisor
- Reasons MDH Would Do All or Part of a Visit
- Chapter 3
- Future follow-up
- Conducting the Visit
- Preparing for the Visit
- Information for the Visit
- Site Visit Checklist
- Scheduling the Visit
- Chapter 4
- After the Site Visit
- MnVFC Provider Follow-up Plan
- MnVFC Site Visit Storage and Handling Per Unit Answer Sheet
- Section 6 Inventory
- Section 5 Storage amp Handling Site-Wide
- Section 4 Storage amp Handling Per Unit
- Section 3 Documentation
- Section 2 Eligibility
- Section 1 Provider Details
- The Site Visit Reviewer Legend
- MnVFC Site Visit Questionnaire
- Required Paperwork for Site Visits
- Chapter 5
-
IPI Advisor Manual | February 2017 Page 29
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 37
3 Documentation VIS amp VAERS
Question 37 Review the providerrsquos Vaccine Information Statements (VISs) and discuss providerrsquos VAERS process toanswer the questions below
A Does the provider have readily available up-to-date VISs for all ACIP-recommendedvaccines relevant to the populations it serves
Yes No [X]
B Does the provider make a VIS available for patientsparents before eachvaccination
Yes No [X]
C Does the provider know how and when to report clinically significant adverseevents using VAERS
Yes No [X]
Review CDC Requirement
VFC providers are required to distribute the current Vaccine Information Statements (VIS) each time a vaccine is administered and maintain records in accordance with the National Childhood Vaccine Injury Act (NCVIA) which includes reporting clinicallysignificant adverse events to the Vaccine Adverse Event Reporting System (VAERS) For a list of current VISs visit CDCrsquos Vaccine Information Statements (httpwwwcdcgovvaccineshcpvis) website
Gal of this question Ensure the site has the most current VISs and is giving them to each patientparent before administering the vaccine in compliance with the federal law Parents must be educated about the vaccine their child will receive and be aware of possible contraindications and side-effects in order to make well-informed decisions about their childrsquos health
Helpful information bull Ask to see the sitersquos VISs to determine if they have an active protocol for giving VISs to parents Review to make sure they are current Ask if they know where and how to report vaccine adverse events
Resources bull Section 3 in the MnVFC Policies and Procedures Manual bull CDC Vaccine Information Statements (wwwcdcgovvaccineshcpvisindexhtml) Site may sign up for email updates for the current list of VIS publication dates for the most up-to-date version
bull IAC Itrsquos Federal Law You must give your patients current Vaccine Information Statements (wwwimmunizeorgcatgdp2027pdf)
bull VAERS (httpsvaershhsgovindex)
Question 38
3 Documentation Anaphylaxis protocol
Question 38 Does the site have an anaphylaxis protocol which is clearly posted near the emergency kit
Answers (Choose one)
Yes No [X]
Review CDC Requirement
An anaphylaxis protocol must be clearly posted in the area where vaccines are administered
Goal of this question Make sure site is prepared for a severe allergic or anaphylactic reaction to a vaccine
Resources bull Section 11 in the MnVFC Policies and Procedures Manual bull IAC protocols Child and Teens (wwwimmunizeorgcatgdp3082apdf) and Adults (wwwimmunize orgcatgdp3082pdf)
Page 30 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
i
i i i - li i i i i i l
Section 4 Storage amp Handling Per Unit The goal of this section is to assess vaccine storage
2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet practices in each unit at the site MnVFC PIN ___________________
The 2017 MnVFC Storage amp Handling Per Unit Answer Sheet is a worksheet to document the answers to the questions in this section for each unit (combination or stand-alone) Fill in the answers to the questions in Section 4 on the answer sheet not in the questionnaire
The answer sheet has an abbreviated form of each question If you need further information on that question refer back to the full questionnaire Also if you find an area where the site is not meeting the requirements you will need to go back to that question on the 2017 MnVFC Site Visit Questionnaire to complete ldquoActions if Non- compliantrdquo section including the root cause analysis and follow-up sections If there is a problem in more than one unit make a note on the questionnaire which unit you are referring to in the Notes section
Important You must fully assess any unit that may be used to store VFC vaccines even if there are no VFC vaccines there on the day of the visit If there are no vaccines and the site is not documenting twice a day temperatures discuss the need to ensure the unit is maintaining stable temperatures by monitoring for one week before placing vaccines in the unit
Quest on number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
for the freezer and e co umn
Temperature Monitoring Dev refr gerator f the un
ce Quest ons Quest ons 4 3 4 7 must be answered separate y t s a combo Be sure to document responses n the appropr at
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
44D Data downloaded and reviewed routinely (eg weekly)
Yes No [O]
Yes No [O]
45A Certificate of Calibration Testing Yes No [X]
Yes No [X]
45B Date of calibration
45C Date certificate expires [X] Follow-up is required if expired [X] Follow-up is required if expired
45D Certificate contains all necessary items
Yes No [X]
Yes No [X]
46 Probe properly placed Yes No [X]
Yes No [X]
47A Two temperature readings per day
Yes No [X]
Yes No [X]
47B Time date and name (or initials) for each reading
Yes No [X]
Yes No [X]
47C Current temperature and minmax temperatures (if
Current ________deg Minimum ________deg Maximum _deg
Current ________deg Minimum ________deg Maximum _deg
Sections 5 and 6 contain questions about storage and handling site wide and inventory It is helpful to keep those questions in mind as you assess the individual storage units Think about dorm-style units expired vaccine vaccine supply room for vaccine stocking all the recommended vaccines and separation of stock if appropriate
NOTE The sections that follow require reviewers to validate responses by looking at vaccine storage units temperaturemonitoring equipment and the vaccine inventory inside a unit bull For section 4 use a separate Storage amp Handling Per Unit Answer Sheet for each unit to document the findings (combination
units using both sections can be documented on the same answer sheet) bull When an unmet requirement is identified return to this questionnaire to complete the ldquoActions if Non-compliantrdquo section for
that question bull After you complete one answer sheet for each unit return to the questionnaire to complete sections 5 and 6 using information
you gathered while assessing the units The questions in sections 5 and 6 (Storage amp Handling Site-Wide and Inventory) are notunit-specific but do require that the response be based on a thorough assessment of all the providersrsquo units
4 Storage amp Handling Per Unit
Description On the Storage amp Handling Per Unit Answer Sheet place a name that will allow you or someone else from your program to easily identify this unit in the event of follow-up We recommend using Brand + Location(example Samsung - Room 123) Save each Storage amp Handling Per Unit Answer Sheet with the Brand + Location in the file name
(example SamsungRoom123doc)
IPI Advisor Manual | February 2017 Page 31
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 41
4 Storage amp Handling Per Unit Storage Unit Build amp Use
Question 41 Below select the build and use of the vaccine storage unit you are assessing
Note to Reviewer Dorm-style units Do not add dorm-style units here Dorm-style units will be addressed in section 5 Units storing only private stock You must review these storage units even if they contain only private stockat the time of the visit because that vaccine could be administered to VFC patients
A What type of unit is this A Stand-alone B Combination
B Select use if stand-alone A Freezer B Refrigerator
Select use if combination A Use both sections to store vaccine B Use freezer section only to store vaccine C Use refrigerator section only to store vaccine
Goal of this question Identify the unit you are evaluating The description asks you to create a unique name for this unit so that you will be able to identify the same unit in future site visits Put this description on the top of the answer sheet (ie make and location)
Helpful information bull A stand-alone unit is either a refrigerator or a freezer It does not have both sections in the unit bull If there is a combination unit note if the site uses both the refrigerator and freezer or only one section of the unit to store vaccines CDC does not recommend the use of either section or the freezer section only of combination household units
bull If your site utilizes the separate stock method of vaccine management you must review storage units even if they contain only private stock at the time of the visit because there is a chance that those vaccines could be administered (borrowed) to VFC-eligible patients
Page 32 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 424 Storage amp Handling Per Unit CDC Recommended Storage Units
Question 42 Below document the grade of the vaccine storage unit you are assessing
Note to Reviewer Pharmaceutical Also called ldquopurpose-builtrdquo these units are designed by the manufacturer specifically tostore vaccines or other biological materials Commercial Although usually intended to store food and beverages commercial units are often larger and more powerful than the household units found in most homes Though these units are intended to meet thehigher demands of larger facilities these units are not specifically built for the storage of biologicalmaterials Household (non-commercialdomestic) These units are usually smaller than commercial units and areintended for use in small offices and in homes ndash typically for food storage However just like commercialunits they are not designed specifically for the storage of biological materials Such units are usually available in common home supply stores
Answers (Choose one)
Select grade A Pharmaceutical B CommercialHousehold
[O] CDC does not recommend the use of both sections or the freezer section only of combination commercialhousehold units
Review CDC Recommendation
CDC recommends the following vaccine storage unit types (in order of preference) pharmaceutical grade stand-alone orcombination units (preferred) householdcommercial stand-alone units householdcommercial combination units using therefrigerator section only
Goal of this question Assess the grade and type of each storage unit bull Pharmaceutical grade units may be stand-alone or combination units that are often metal may have glass in the door for viewing inside often have an external digital temperature display and are manufactured by medical companies
bull Commercial or household units often look like your kitchen appliance have vegetablemeat drawers in the unit and are manufactured by household appliance companies
bull Occasionally you might find a medical grade unit which is usually a commercialhousehold unit with a lock and 3-prong plug These are still considered household units because of their ability to maintain proper temperatures and air flow Studies show that household stand-alone units are better able to maintain consistent temperatures than their combination counterparts Combination household units used to store vaccine in both sections of the unit is no longer recommended and may be prohibited in the future Combination household storage units that are having difficulty maintaining a cold enough freezer temperature and a warm enough refrigerator temperature should be replaced or a separate stand-alone freezer should be purchased
For frozen vaccines the most cost effective solution is for the site to purchase a small stand-alone freezer The site may need time to budget for a stand-alone storage unit
Resources bull Replacing Combination Household Units Tip Sheet on IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml)
IPI Advisor Manual | February 2017 Page 33
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 434 Storage amp Handling Per Unit Temperature Monitoring Device in the Unit
Question 43 Determine whether there is a temperature monitoring device in this section of the storage unit andanswer the questions
A Is there a temperature monitoring device in this section of thestorage unit
Yes No [X] (If no skip to question 47)
B Who is responsible for supplying the temperature monitoring device in this section of the storage unit Provider
Review CDC Requirement
Certificates of calibration testing provide confidence that the temperature monitoring device is measuring temperaturesaccurately All units storing VFC vaccines must have a calibrated temperature monitoring device with a current and valid certificateof calibration testing All certificates must contain modeldevice name or number serial number date of calibration testing (report or issue date) and Instrument Passed testingInstrument in Tolerance (Recommended uncertainty = +-05ordm C (+-1ordm F))
Goal of this question Assess whether there is a temperature monitoring device in the unit If the unit is not being monitored at all call MDH at 651-201-5522 for guidance
Helpful information bull This question does not ask whether the temperature monitoring device is working or the characteristics of the device These issues will be addressed later in the questionnaire
bull For part B the provider is always responsible for supplying the temperature monitoring device Even if their thermometer or data logger was originally from MDH it is their responsibility to ensure it is functional and calibrated
Resources bull Section 8 in the MnVFC Policies and Procedures Manual
Page 34 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 444 Storage amp Handling Per Unit CDC Recommended Temperature Monitoring Device
Question 44 Assess the temperature monitoring device in this section of the storage unit to answer the questionsbelow
A Is the temperature monitoring device a continuous monitoring and recordingdevice (eg data logger)
Yes No [O] (Skip D)
B Does the temperature monitoring device have a probe in buffered material Yes No [O]
C Does the temperature monitoring device have a digital display that can beeasily read from the outside of this unit
Yes No [O]
D Is data downloaded and reviewed routinely Yes No [O]
Review CDC Recommendation
As of Jan 1 2018 all VFC providers must use continuous temperature monitoring devices (eg data loggers) to monitor vaccinesthat will be administered to VFC-eligible children Routine review and accessibility of temperature data is critical for determining whether vaccine has been properly stored and for assessing usability of vaccine that was involved in a temperature excursion Tomeet VFC Program requirements the device must also be equipped with bull A temperature probe bull An active temperature display that can be easily read from the outside of the unit bull The capacity for continuous monitoring and recording capabilities where the data can be routinely downloaded
The following are additional recommended features for these devices bull Alarm for out-of-range temperatures bull Current minimum and maximum temperatures display bull Low battery indicator bull Accuracy of +- 1degF (05degC) bull Memory storage of at least 4000 readings bull User programmable logging interval (or reading rate) recommended at a maximum time interval of every 30 minutes bull Use of a probe that best reflects the temperature of the vaccine (such as a buffered probe)
Goal of this question Assess the temperature monitoring device in the storage unit Note that these are all recommendations not requirements at this time
This is a great teaching opportunity for sites who do not currently have a continuous temperature monitoring device Beginning Jan 1 2018 all units that store MnVFC vaccine will be required to have a continuous temperature monitoring device (ie a data logger or a continuous temperature monitoring system) Unlike a minmax thermometer a continuous temperature monitoring device provides detailed information on all temperatures recorded at pre-set intervals For excursions it can provide information on when a temperature went out-of-range for how long and what the temperatures were This is essential information that vaccine manufacturers need to know to assess the viability of the vaccine following an excursion
Helpful information bull Sites are required to monitor and record temperatures twice daily however temperature excursions can easily occur in the 12 hours or longer between readings Continuous temperature monitoring can help manufacturers determine vaccine viability
bull Continue to encourage sites to document and evaluate minimum and maximum temperatures the storage unit reached since the last reading and respond appropriately to out-of-range temperatures
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The 2017 MnVFC Site Visit Paperwork Chapter 4
bull It is recommended that sites download and review data weekly Discuss with sites that reviewing temperature monitoring device data also includes responding appropriately if they identify out-of-range temps
bull There is sometimes confusion about the difference between a data logger and a continuous temperature monitoring system Here are some differences
Data Loggers Continuous Monitoring Systems Have an external display similar to thermometers May or may not have an external display Have a detachable probe Probe is usually attached to transmitter Need to be plugged into the computer or cradle to download information on a regular schedule
Wirelessly sends data to computer system
Create a file of data that needs to be saved on the computer
Data is stored within the system not a separate file
Doesnrsquot allow documentation of twice a day temperature checks in the file
May allow documentation of twice a day temperature checks within the system
More about the 2018 requirement for a continuous temperature monitoring device
Required Features bull The continuous temperature monitoring device must have Continuous monitoring and recording capabilities to track and record temperatures over time The capacity to routinely download temperature data to a computer (recommended at least weekly) or wirelessly transmit data Detachable probe in a bottle filled with a thermal buffer (eg bio-safe glycol) if the data logger needs to be detached in order to download data Active temperature display
Recommended Features bull MnVFC recommends continuous temperature monitoring devices with Alarm for out-of-range temperatures Accuracy within +-1degF (+- 05degC) Low battery indicator Display of current minimum and maximum temperatures Memory storage of at least 4000 readings User programmable logging intervals (eg the user can set how often the device records the temperature)
Note that these are all currently recommendations not requirements yet
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
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The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 45
Goal of this question Ensure the temperature monitoring device is properly calibrated The certificate of calibration testing means that the device has been tested and it is accurately measuring temperatures within established testing limits The certificate of calibration ensures that the device meets all the required components
Helpful information bull The provider is always responsible for having a current certificate of calibration (or copy) on-site
bull To be considered ldquovalidrdquo a certificate of calibration must contain these required elements Modeldevice name or number Serial number
4 Storage amp Handling Per Unit Certificate of Calibration Testing
Review CDC Requirement
Certificates of calibration testing provide confidence that the temperature monitoring device is measuring temperaturesaccurately All units storing VFC vaccines must have a calibrated temperature monitoring device with a current and valid certificateof calibration testing All certificates must contain modeldevice name or number serial number date of calibration testing (report or issue date) and Instrument Passed testingInstrument in Tolerance (Recommended uncertainty = +-05ordm C (+-1ordm F))
Question 45
Note to Reviewer
A
B
C
D
E
Review the certificate of calibration testing for the temperature monitoring device in this section of the storage unit and answer the questions below
bull How to determine certificate of calibration testing expiration date 1) Identify the certificate issuecalibration date 2) Apply the Immunization Program-required frequency for calibration testing Example If the
issuecalibration date is 12312013 and Immunization Program policy requires testing every twoyears the expiration date is 12312015
bull Certificates must include all of the below bull ModelDevice Name or Number bull Serial Number bull Date of Calibration Testing (Report or Issue Date) bull Instrument Passed testing (Instrument in Tolerance)
Is there a certificate of calibration testing for the temperature monitoring Yes device in this section of the storage unit No [X]
What is the date of calibration for the temperature monitoring device in this section of the storage unit
What is the certificatersquos date of expiration based on ImmunizationProgram policy (See note to reviewer to determine expiration date) [X] Follow-up is required if
certificate is expired
Does the certificate contain all the necessary items listed in the Note to Yes Reviewer No [X]
Who is responsible for supplying the current and valid certificate of Provider calibration for this temperature monitoring device
Date of calibration testing (report or issue date) Note If there is no expiration date the certificate expires 2 years from the date of calibration Whether the instrument passed or failed testing (or instrument in tolerancenot in tolerance)
bull Recommended element Documented uncertainty of +- 1degF [05degC]
If these elements are present the certificate is considered valid If the certificate contains information about the recommended element or the entity that issued the certificate that is helpful but not required
To determine if a certificate of calibration testing was issued by an appropriate entity check to see if the certificate indicates one or more of these items (this is the wording used to help sites evaluate if their calibration is accurate but is not required on the certificate itself to be considered valid)
bull Conforms to ISO 17025 bull Performed by an ILACMRA Signatory body accredited laboratory You can review this list of the ILAC MRA and Signatories (httpilacorgilac-mra-and-signatories)
bull Traceable to the standards maintained by NIST bull Meets specifications and testing requirements for the American Society for Testing and Materials (ASTM) Standard E2877 tolerance Class F (le 05 degC) or better
bull Includes reference to another acceptable accuracy validation method such as comparison to other traceable reference standards or tests at thermometric fixed points
Note CDC recommends that certifications be issued for the entire monitoring unit (detachable probe data logger etc) and not individual certificates for each component
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The 2017 MnVFC Site Visit Paperwork Chapter 4
For 45 E the provider is always responsible for supplying the current and valid certificate of calibration for a temperature monitoring device
bull Tip If the temperature monitoring device has a sticker on the back with the calibration date the site can usually call the company who calibrated the device and get a copy of the certificate if they donrsquot have one
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 46 4 Storage amp Handling Per Unit Probe Placement
Question 46 Is the probe properly placed in this section of the storage unit
Note to Reviewer ldquoProperlyrdquo means that the probe in a commercial or household unit is placed in a central area of the unitdirectly with the vaccines Probes should not be placed in the doors near or against the walls close to vents or on the floor of the unit The only allowable exemption related to this requirement is for providerswho have pharmaceutical storage units (built for vaccine storage) that have either (1) a built-intemperature monitoring device OR (2) a dedicated port for the probe that dictates the placement of theprobe
Answers (Choose one)
Yes No [X]
Review CDC Requirement
The probe must be placed in a central area of the section of the storage unit directly with the vaccines in order to properly measurevaccine temperature The probe should not be placed in the door near or against the walls close to vents or on the floor of theunit For pharmaceutical units with a built-in temperature monitoring device or a dedicated port for a probe that is not in thecenter of the section of the storage unit consult your Immunization Program for guidance on placement
Goal of this question Make sure the temperature monitoring device is in the best location to accurately measure the temperature of the vaccines stored in the unit
Helpful information bull The probe of the temperature monitoring device should be placed directly with the vaccines in the middle of the unit The ONLY allowable exception is for pharmaceutical storage units that have either a built-in thermometer or a dedicated port for the probe that indicates placement of the probe
bull Temperatures can vary within the unit especially household units bull Call MDH at 651-201-5522 if you have questions
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Guide (wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml)
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The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 474 Storage amp Handling Per Unit Temperature Documentation
Question 47 Review the temperature documentation over the past three months for this section of the storage unit todetermine whether the provider has a process in place for properly documenting temperatures twice aday Answer the questions below
A Are there two temperature readings recorded for this section of the storage unit per day
Yes No [X]
B Is there a time date and name (or initials) recorded for each reading Yes No [X]
C What is the current temperature and minmax temperatures (if available) inthis section of the storage unit Use the reviewerrsquos thermometer if the providerrsquos temperature monitoringdevice does not have a current valid certificate of calibration testing or the probe is not properly placed in this section of the storage unit
Current Temperature Minimum Temperature Maximum Temperature Fahrenheit Celsius
D Based on your review of the providerrsquos recent temperature documentationincluding the current temperature is this section of the storage unitmaintaining appropriate temperatures
Yes No [X] Not enough information [X]
Review CDC Requirement
Vaccines must be stored under appropriate temperatures as described in the package inserts at all times Acceptable temperature ranges vary by vaccine type and the range is 36deg F and 46deg F (2deg C and 8deg C) and for frozen vaccines the range is -58deg F and +5deg F (shy50deg C and -15deg C) Exposure to temperatures outside of those included in the package inserts could affect vaccine viability andultimately could leave children unprotected against vaccine-preventable diseases In order to maintain awareness of storage unittemperatures and ensure that vaccines are being stored at appropriate temperatures at all times VFC providers are required to monitor and document temperatures for all vaccine storage units at least twice a day Temperature documentation must contain (1) at least two temperature readings per day (2) the time and date of each reading and (3) the name (or initials) of the personwho assessed and recorded the readings CDC also recommends that VFC providers record the minimum and maximumtemperatures of each unit once each workday (preferably in the morning)
Goal of this question Ensure the temperature is being monitored twice daily is within the required range and documented correctly Use your thermometer to check the temperature if the sitersquos temperature monitoring devicersquos probe is not properly placed or there is not a current certificate of calibration Place your thermometer in the unit at the beginning of the visit to allow sufficient time to reach an accurate temperature The purpose of using your thermometer is to ensure the vaccine is being stored at the proper temperature not to ldquovalidaterdquo their reading
Question 47 D is an assessment question based on information you have learned during your visit You might answer ldquonot enough informationrdquo if the unit is new and they donrsquot have at least three months of data or if the unit is only used as overflow and they are inconsistent with temperature monitoring Mark ldquoNordquo if you have reason to believe the storage unit is not maintaining temperatures properly
Helpful information bull All sites must document temperatures twice a day every day the site is open even if they have a data logger or continuous monitoring system
bull Sites can document the information electronically with some continuous monitoring systems as long as it can show what the current temp is the date time and initials of the person checking ndash this needs to be someone at the site ndash not checking remotely or centrally for a large site or system The site must be able to produce these records during their site visit Reviewing these files can be a challenge due to large volumes and lots of paper
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Temperature Logs on Managing Vaccine (wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml)
IPI Advisor Manual | February 2017 Page 39
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 484 Storage amp Handling Per Unit Temperature Excursions
Question 48 In the event that a temperature excursion(s) occurred in this unit within the last three months requestand review documentation of actions taken to determine whether the provider has a process for properlyaddressing excursions Answer the questions below
A Were vaccines in this unit exposed to out-of-range temperatures in the lastthree months (including today)
Yes No (If no skip to question 49)
B Did the provider quarantine and label vaccines as ldquoDo not userdquo Yes No [X]
C Did the provider place vaccine in a unit where it can be stored under properconditions if applicable
Yes No [X]
D Did the provider contact the Immunization Program to report theexcursion
Yes No [X]
E Was the manufacturer contacted for documentation supporting theusability of the vaccine
Yes No [X]
Review CDC Requirement
The provider must document all excursions and actions taken including the following (1) Quarantine and label vaccines as ldquoDO NOTUSErdquo (2) Place vaccines in a unit where they can be stored under proper conditions (3) Contact the Immunization Program to report an excursion and (4) Contact the vaccine manufacturer to obtain documentation supporting the usability of the vaccine
Goal of this question Address any out-of-range temperatures (temperature excursions) identified in reviewing the last three months of temperature logs or during the site visit If there were any out-of-range temperatures did the site respond appropriately to the situation This is a great opportunity to discuss what to do in the event of an excursion The Clinicians Storage and Handling Mishap Checklist is in the IPI Site Visit information folder and is a good review of the process
Helpful information bull Sites need to know that an excursion does not automatically mean that exposed vaccines are non-viable or unusable Exposed vaccines must be quarantined (marked ldquoDo Not Userdquo) and stored under proper conditions until they have received information from vaccine manufacturers regarding the viability of the vaccine
bull Sites must inform MDH when an excursion occurs
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Clinicians Storage and Handling Mishap Checklist (wwwhealthstatemnusdivsidepcimmunize ipivaxchklstpdf)
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Question 49
Goal of this question Ensure proper placement of vaccines in the storage unit
Note These are all recommendations (best practices) not requirements
Helpful information bull Store vaccine in the middle of the compartment two to three inches away from the coils walls floor and cold air vent The temperature near the floor and walls of the unit differs from that in the middle of the compartment and the cold air vent can freeze refrigerated vaccines
4 Storage amp Handling Per Unit Vaccine Placement
Question 49 Look inside the unit to answer the questions below
A Are vaccines placed in the middle of the unit with space between vaccinesand the sideback of the unit to allow cold air to circulate
Yes No [O]
B Are vaccines stored in their original packages Yes No [O]
C Are there water bottles (for refrigerators) or frozen water bottles (forfreezers) in the unit
Yes No [O]
D Are vaccines store in the doors vegetable bins under or near cooling ventsor on the floor of the unit
Yes [O] No
E Is food being stored in the unit Yes [O] No
Review CDC Recommendation
Vaccines should be stored in their original manufacturer (or CDC centralized distributor) packaging They should be placed in the middle of the unit with space between the vaccines and the sideback of the unit to allow cold air to circulate Vaccines SHOULD NOT be stored in the doors vegetable bins or floor of the unit or under or near cooling vents and there should not be any food inthe unit Water bottles (for refrigerators) or frozen water bottles (for freezers) should be placed throughout each storage unit inorder to (1) stabilize or extend temperatures during a power outage and (2) to serve as physical blocks preventing the placementof vaccines in areas of the unit that are at higher risk for temperature excursions (such as in doors vegetable bins floor ornearunder cooling vents)
bull Vaccines should be kept in their original packaging to Protect them from light Help prevent medication errors by making labels easier to read Provide a moisture barrier that serves as insulation in case of an out-of-range temperature power outage door left open or mechanical failure Simplify managing vaccine inventory
bull Store water bottles in the doors on the floor and near the cold air vent in the refrigerator and frozen water bottles in the freezer to help maintain a stable temperature if there is a power failure and when the door is opened frequently Too many water bottles in the door can prevent the door from closing tightly Mark water bottles ldquoDo Not Drinkrdquo
bull Do not store vaccine in the door or drawers of the refrigerator or freezer Vegetable bins and crisper drawers should be removed from refrigerators or used to store other medical supplies or water bottles
bull If vaccine is stored in a household combination refrigeratorfreezer The top shelf should not be used for storing vaccine because the cold air vent blowing from the freezer will freeze vaccine located there If you must use the top shelf of this type of unit place water bottles underneath the cold air vent to prevent vaccine from being stored there It is recommended that only the refrigerator be used for vaccine storage and a separate stand-alone freezer be used to store frozen vaccine
bull Must not store food or beverages in the refrigerator or freezer because frequent opening of doors can lead to temperature variations that may affect vaccine viability There is also a risk of contaminating vaccines
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Guide (wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml) bull Vaccine Storage Tip Sheet on IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml)
IPI Advisor Manual | February 2017 Page 41
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 4104 Storage amp Handling Per Unit Disconnection from Power Source
Question 410 Ask the provider to demonstrate what measures are taken to ensure that vaccine storage units are notaccidentally physically disconnected from the power supply Which of the following describes the measure(s) taken on this unit
Note to Reviewer bull Large hospitals and healthcare systems may not have the ability to demonstrate labels on plugs or circuitbreakers In such cases verify that the practice has a comprehensive policy and standard operatingprocedures in place to prevent the vaccine storage unit from being physically disconnected from thepower supply
bull While back-up generators may ensure power to the overall facility this question ONLY addresses thevaccine storage unit being accidentally disconnected from the power source either through the plug orthe circuit breaker
Answers A ldquoDo not disconnectrdquo labels on the plug (Choose all that B ldquoWarningrdquo label on the circuit breaker box
apply) C Hard-wired (ie built-in) and has a ldquoDo not disconnectrdquo label on thecircuit breaker box D Hospital or large health care system with a comprehensive written policyand standard operating procedures detailing measures taken to preventvaccine storage units from being accidentally disconnected from the powersupply E No acceptable measures for preventing accidental disconnection frompower supply [X]
[X] The response is non-compliant if only A only B or E is selected
Review CDC Requirement
VFC providers must take steps to protect the power source for all vaccine storage equipment by means of having clear warninglabels on both the plug and the circuit breaker associated with all vaccine storage units Large hospitals and healthcare systems canmeet this requirement by demonstrating that they have comprehensive policies and standard operating procedures to preventvaccine storage units from being physically disconnected from the power supply
Goal of this question Decrease the chance that a vaccine storage unit will be accidently unplugged or power will be turned off while vaccine is in the unit This question addresses only what measures the site has taken to ensure the storage unit is not physically disconnected from its power source
If the site uses labels on the plugs and circuit breakers perform a visual inspection to assess whether the way the stickers are positioned make it clear and obvious to anyone that these units are not to be disconnected
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Do Not Unplug and Warning stickers are included in the folder or available to order on the For
Professionals Order Form (wwwhealthstatemnusdivsidepcimmunizeordermathtml)
Note Once you have completed the 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet for each unit return to the questionnaire to complete sections 5 and 6
Page 42 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
- -
Section 5 Storage amp Handling Site-Wide Question 51
5 Storage amp Handling Site Wide Discussion of Cost amp Quantity of Vaccine
Question 51 Have a discussion with the provider about the cost and quantity of VFC vaccines they are responsible for annually Address the points listed in the note to reviewer below
Note to Reviewer bull Vaccine Shipped (Required) Share the cost of VFC vaccines shipped to the provider in the last calendaryear to make sure the provider understands the contribution made by the VFC Program to their practiceFor new providers who do not have ldquocalendar yearrdquo data share either the actual cost of their currentinventory or use the cost of 10 VFC doses of each of the ACIP-recommended vaccines (approximately $7000) to help estimate their annual cost
bull Storage amp Handling (Required) Make sure the provider understands the cost of vaccines for which they are responsible when they make decisions about purchasing recommended vaccine storage and temperature monitoring equipment
Answer I have discussed with the provider the cost and quantity of vaccines ordered in the previous calendar year
Goal of this question Inform sites of the quantity and value of vaccines that they receive as part of the MnVFC program Providers often donrsquot realize the value of the vaccine in their unit This information is included on your clinic list and on the one page site-specific information
Helpful information bull This discussion must occur and the box on the questionnaire must be checked bull If there isnrsquot actual vaccine value information available tell the site that one vaccine order that includes a box of each of the ACIP recommended vaccines costs approximately $7000
bull MDH may not have specific information for individual sites if they receive vaccine from a central warehouse or pharmacy For those sites MDH will give you numbers for the whole system so you can discuss system wide data as appropriate If individual site information is also included it is usually just varicella-containing vaccines that must be shipped directly to the site
Question 52
5 Storage amp Handling Site Wide Dorm Style Units
Question 52 Determine whether the provider has any dorm-style units on site and answer the questions below
Note to Reviewer A dormitory-style refrigerator is a unit that has both refrigerator and freezer compartments behind a singleexterior door Dorm-style units also have an evaporator plate (cooling coil) which is usually located insidean icemaker compartment (freezer) within the refrigerator
A Does the provider have any dorm-style units that are used at any time tostore vaccines
Yes [X] No (Skip to question 53)
B Does the provider have sufficient space in existing compliant vaccinestorage units to store all vaccines without use of the dorm-style unit at any time
Yes No [X]
Review CDC Requirement
Dorm- and bar-style units are prohibited for vaccine storage Vaccines stored in dorm-style units are considered non-viable and must be returned to the centralized distributor CDC recommends the following vaccine storage unit types (in order of preference)pharmaceutical grade stand-alone or combination units (preferred) householdcommercial stand-alone unitshouseholdcommercial combination units using the refrigerator section only
Goal of this question Ensure no vaccine is stored in dorm-style units even for short periods of time Encourage them to label any units ldquoNo Vaccine Storage Allowedrdquo Vaccine stored in these units is considered non-viable If a site is using a dorm-style unit call the MnVFC program (651-201-5522)
Resource Section 8 in the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 43
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 535 Storage amp Handling Site Wide Storage Unit Space Availability
Question 53 Does the provider have sufficient room across storage units to store current stock as well as anyadditional stock acquired during peak season without overcrowding
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have sufficient storage space to accommodate vaccine stock at the busiest time of year without overcrowding
Goal of this question Ensure that sites have sufficient space in their units to maintain vaccines at the busiest time of year Overcrowding of vaccine limits air circulation and affects the unitrsquos ability to maintain stable temperatures
Helpful information bull Look for signs of overcrowding such as vaccines that are pushed up against the wall bins that are overflowing or storage units that are full during non-peak seasons
Discuss immediate actions if the unit is overcrowded Move some of their vaccines order less vaccine more frequently (once per month preferably) andor purchase another storage unit for overflow
Resource bull Section 8 MnVFC Policy and Procedure Manual
Page 44 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 545 Storage amp Handling Site Wide Expired Vaccines
Question 54 Look in each unit Are there expired vaccines in any of the vaccine storage units at this site
Answers (Choose one)
Yes [X] No
Review CDC Requirement
Vaccines should be rotated weekly and when a new shipment comes in so that longer-dated vaccines are stored behind shorter-dated vaccines If vaccines expire they can no longer be stored in the same storage unit with viable vaccines They must be placedin a container or bag clearly labeled ldquoDo not userdquo and separated from viable vaccines to prevent inadvertent use Expired vaccinemust be returned to the centralized distributor within six months of expiration
Goal of this question Ensure there is no expired vaccine in any storage unit
Helpful information bull Sites can prevent their stock from expiring by rotating vaccines every week andor when a new shipment arrives Longer-dated vaccines are stored towards the back of the unit and shorter-dated vaccines are up front
bull Pay attention to vaccines that expire within the next three months Consider transferring vaccine that will expire soon to another MnVFC-enrolled site that will use the vaccine preferably a site close by It is the transferring sitersquos responsibility to arrange the transfer of the vaccine Be sure to complete the MDH Vaccine Transfer Record form and send it to MDH If they are having difficulty finding a location to accept vaccine contact MDH
bull This is a great opportunity to educate sites about the MDH Nonviable Vaccine Form and the process for returning vaccine The VFC program does get some credit for taxes and fees on vaccine that is returned to the distribution center
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MDH Nonviable Vaccine Form and MDH Vaccine Transfer Record on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfcformshtml)
IPI Advisor Manual | February 2017 Page 45
The 2017 MnVFC Site Visit Paperwork Chapter 4
- -
-
Question 555 Storage amp Handling Site Wide Back up Thermometer
Question 55 Does the provider have a readily available back-up thermometer with a current and valid certificate ofcalibration testing
Note to Reviewer ldquoReadily availablerdquo means that the thermometer is available to perform twice-a-day monitoring for a unit asrequired CDC recommends that the back-up thermometer be maintained on site
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have a readily available back-up thermometer with a current and valid certificate of calibration testing Toprevent the certificates of calibration testing of the primary and back-up thermometers from expiring at the same time the date of calibration testing (or issue date) of the back-up thermometer should be different from the date of calibration testing (or issue date) of the primary thermometer As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meetsVFC program requirements
Goal of this question Ensure sites have one calibrated back-up thermometer onsite that is readily available in the event that the temperature monitoring device in unit fails transportation of vaccine is needed or there are other unexpected circumstances
Helpful information bull As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meets VFC Program requirements
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 56 5 Storage amp Handling Site Wide Preparation of Vaccine
Question 56 When does this provider prepare vaccine for administration to the patient
Note to Reviewer For mass vaccination clinics if one type of vaccine is offered providers may pre-draw up to 10 doses Ifusing pre-filled syringes pre-drawing also means activating the syringe by removing the needle guard orattaching a needle
Answers (Choose all that
apply)
Prepare dose immediately before administration Pre-draw doses for upcoming patients (in a regular clinicpractice) [O] Pre-draw up to 10 doses (in a mass-vaccination clinic) Pre-draw more than 10 doses (in a mass-vaccination clinic) [O] Other [O]
Review CDC Recommendation
CDC recommends preparing vaccines immediately prior to administration in order to assure viability of vaccine and prevent vaccinewastage Vaccines that are not administered immediately are at risk of exposure to temperatures outside of the required rangewhich can affect vaccine viability and ultimately can leave children unprotected against vaccine-preventable diseases
Goal of this question Discuss proper timing and preparation of vaccine(s) for administration These are recommendations not requirements
Helpful information bull Educate staff on the importance of preparing vaccine immediately before administration Pre-drawing of vaccines may lead to concerns related to vaccine viability potency sterility and wastage
Page 46 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 6 Inventory Question 61
6 Inventory Inventory Comparison
Question 61 Visually inspect storage units to determine if existing supply of vaccines proportionately mirrorspopulations served Choose the most accurate statement below
Note to Reviewer bull CDC recommends that providers maintain a four-week supply of inventory bull For this question do not take into account vaccine types that the provider does not order Here simply
make sure that overall the vaccines in the providerrsquos storage units are available in sufficient amounts toserve their patient population
Answers (Choose one)
The current vaccine inventory proportionately reflects the populations identified Only public stock is insufficient [X] Only private stock is insufficient [X] Both public and private stock are insufficient [X] Site uses the replacement method but does not appear to have enough vaccine for their population [X] Other [X]
Review CDC Requirement
VFC providers must order and stock routine vaccines in accordance with their patient population in order to prevent missedvaccination opportunities Having sufficient amounts of all stocks prevents the inadvertent use of VFC vaccines for non-VFC-eligiblepatients and vice versa
Goal of this question Assess whether the site is ordering appropriate quantities of vaccine for the population they serve at their site
Helpful information bull If the site sees 30 percent private-pay patients and 70 percent VFC the stock in their storage units should reflect that proportion If you donrsquot know you can ask the site about their population
bull This is meant to be a general assessment so in a big site if they have only a small amount of vaccine that may indicate an issue with vaccine management
bull CDC recommends smaller more frequent orders (ie monthly) rather than large orders to minimize the amount of vaccine loss if an incident occurs during shipment or in the storage unit Sites should not order more frequently than once a month
bull Sites using the replacement method will only have one stock but it should appear to be large enough for their population
bull Only assess the vaccine types that the site currently stocks in their unit We know there are sites that do not offer all ACIP-recommended vaccines for various reasons That issue will be addressed in question 62
IPI Advisor Manual | February 2017 Page 47
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 626 Inventory ACIP Recommended Vaccines
Question 62 Review providerrsquos current inventory to answer the questions below
A Does the provider offer all routine ACIP-recommendedvaccines for their patient population
Yes (Skip to question C) No [X] Offers all except varicella because direct ship ofvaccine is unavailable from manufacturer
B Which routine vaccines are NOT being offered DTaP Hepatitis A Hepatitis B HIB HPV Influenza Meningococcal
MMR Pneumococcal Polio Rotavirus TdapTd Varicella
C According to Immunization Program Policy does theprovider make accessible all non-routine ACIP-recommended vaccines for those VFC patients whomeet the criteria for receiving them
Yes (Skip to question 63) No [X]
D Which non-routine vaccines are NOT being offered Pneumococcal polysaccharide vaccine (PPSV23) Meningococcal Group B (MenB) Other
Review CDC Requirement
VFC providers agree to comply with immunization schedules dosages and contraindications that are established by the Advisory Committee on Immunization Practices (ACIP) for the vaccines identified and agreed upon in the Provider Agreement UNLESS bull In the VFC providers medical judgment and in accordance with accepted medical practice the VFC provider deems such
compliance to be medically inappropriate for the child bull The particular requirements contradict state law including laws pertaining to religious and other exemptions The VFC program entitles children to the following vaccines DTaP Hepatitis A Hepatitis B HIB HPV Influenza MeningococcalMMR Pneumococcal Polio Rotavirus TdapTd and Varicella VFC providers are also required to ensure that VFC-eligible children have access to non-routine vaccines as needed
Goal of this question Assess if the site is offering all the ACIP-recommended vaccines for the population they serve and these vaccines are in stock on the day of the visit It is important that every MnVFC-eligible child that comes to a providerrsquos office for an immunization is vaccinated
Helpful information bull The Advisory Committee on Immunization Practices (ACIP) is a group of medical and public health experts that develops recommendations on how to use vaccines to control diseases in the United States
bull Specialty providers are not required to offer all routine vaccines but should provide the vaccines appropriate for their population
bull If the site does not offer all routine ACIP-recommended vaccines appropriate for their population check the ldquoNordquo box in Part A then check the appropriate box(es) in Part B for any vaccines not offered Please contact MDH as this situation offers us the opportunity to provide education to the site
bull For non-routine vaccines they must either be in stock or the site must have an alternative protocol in the routine management plan that ensures these children have access when applicable
Resources bull IAC Diseases and Vaccines (wwwimmunizeorgvaccines) bull CDC Advisory Committee on Immunization Practices (ACIP) (wwwcdcgovvaccinesacipindexhtml)
Page 48 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 636 Inventory Separation of Stock
Question 63 Observe how the provider differentiates stock in each storage unit to answer the questions below
A Is it clear which vaccines belong to public stock andwhich belong to private stock
Yes No [X] Not applicable replacement site
B Is it clear which vaccines belong to VFC stock andwhich belong to UUAV stock
Yes No [X] Not applicable replacement site Not applicable not UUAV-enrolled site
Review CDC Requirement
In order to ensure that VFC vaccines are only administered to VFC-eligible children VFC providers that serve both VFC and non-VFCshyeligible children must maintain their vaccine inventories in such a way that they can clearly differentiate public stock from privatestock as well as VFC from other public stock
Goal of this question Assess whether the site can distinguish between MnVFC vaccine and private vaccine If they participate in the Uninsured and Underinsured Adult Vaccine (UUAV) program they should also be able to distinguish between MnVFC stock and UUAV stock Some sites use labels bins boxes etc to differentiate their stock If it is not clear how the site differentiates their stock discuss vaccine management with the staff For follow-up call MDH to discuss doing a follow-up site visit
Sites using the replacement method will not have separate stocksmdashthis is an approved alternative method for keeping track of vaccine
Resource bull Section 10 of the MnVFC Policy and Procedure Manual
IPI Advisor Manual | February 2017 Page 49
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
MnVFC Site Visit Storage and Handling Per Unit Answer Sheet 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet MnVFC PIN ___________________
Question number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
Temperature Monitoring Device Questions Questions 43 47 must be answered separately for the freezer and refrigerator if the unit is a combo Be sure to document responses in the appropriate column
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
All the questions on the Site Visit Storage amp Handling Per Unit Answer Sheet have been discussed previously in section 4 of this manual Use this sheet to record information about all the units at the site visit You will need one sheet for each unit If it is a combination unit (either pharmaceutical or household) you can record both sections on one sheet If they have stand-alone units use one sheet for each unit Do not enter the answers to the questions in section 4 of the questionnaire
If you need more information about any of the questions refer back to the main questionnairemdashthe complete question additional guidance including notes to the reviewer and the CDC requirements are there Also if the site is not meeting the requirement you will go back to the questionnaire to complete the ldquoActions if Non-compliantrdquo section including the root cause analysis and follow-up sections
When you have completed the assessment of all the storage units remember to go back to the questionnaire to complete sections 5 and 6
Page 50 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
ndash
ndash
MnVFC Provider Follow-up PlanThe goal of the Provider Follow-up Plan is to communicate with the site all of the VFC requirements any unmet requirements found during your site visit and the timeline for completing the required action The left hand column is a box to check for ldquoUnmetrdquo requirements
Helpful information bull The form can be used to review what the site is doing well and what they need to work on
bull For requirements that have specific documentation that needs to be sent to you use the notes section
2017 MnVFC Provider Follow-up Plan Site _______________________________________________ MnVFC PIN ____________ Date of Visit ___________
Thank you for participating in this MnVFC compliance site visit Please review this visit summary including follow-up actions and timelines for completion Unmet MnVFC requirements and recommendations have a checked box next to them The goal of this plan is to support you with successfully implementing the program and improving access to vaccines for VFC-eligible children
Unmet Question VFC Requirements Section 1 Changes to Key Staff
Q12 Change in the Medical Director Immunization Manager Vaccine Coordinator or back-upKey Staff must be communicated to the immunization program by emailing healthmnvfcstatemnus Changes Notes
Q12 Key staff must complete the annual training on VFC program requirements and print theAnnual Training certificate of completion Documentation Required Action
Staff that have not completed the MnVFC online training must complete it and send acopy of the certificate to the reviewer Training can be found on the MnVFC website (wwwhealthstatemnusvfc) Due date 1 month
Notes
Unmet Question VFC Requirements Section 2 Eligibility
Q21 Provider staff must possess a working knowledge of all VFC eligibility criteria and use thoseVFC Eligibility criteria to screen children prior to administering VFC vaccines
Categories Notes
bull This form provides documentation needed for follow-up actions when you send your thank you email
The second to last page of the Provider Follow-up Plan has a summary of the MnVFC program recommendations These are to remind the site about best practices they may want to improve upon even though they are not yet requirements of the program For example you could discuss the recommendation about storage units if they currently have a combination household unit and are using both sections
The last section is for your signature and the person you met with In most sites it will be the immunization manager or vaccine coordinator who signs the form unless the medical director attended the site visit You keep the original copy and the site will need to keep a copy for themselves
To be completed by the site visit reviewer
I acknowledge that a VFC site visit was performed on __________________ (visit date) The follow-up plan which includes a list of all current VFC program requirements and recommendations assessed during the visit and any required follow-up actions was provided at the end of the visit
Site visit reviewer
Phone
Reviewer Signature Date
To be completed by the provider
I acknowledge that our practice took part in the VFC site visit noted above I understand the findings of the visit and any required actions that must be taken by our office in order to meet VFC program requirements
Medical Director (or designee) Name Title
Medical Director (or designee) Signature Date
IPI Advisor Manual | February 2017 Page 51
The 2017 MnVFC Site Visit Paperwork Chapter 4
After the Site Visit Send a thank you email highlighting the unmet requirements documents you need from the site to resolve the issue(s) and the date you need them Make sure to include the link to the Site Visit Survey (httpssurveyvovicicomseashxs=56206EE334CE0B14)
Please refer to Chapter 3 for more information about future follow-up required after the visit including forms and documentation
Resource bull Sample Thank You letter on IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml)
Chapter 5
IPI Advisor Resource List MnVFC Program 651-201-5522
MnVFC wwwhealthstatemnusvfc
bull Separate Stock and Replacement Method Policies and Procedures Manuals bull Online trainings bull MnVFC Announcements sign up to receive them via email bull Ordering MDH vaccine bull MnVFC forms Screening forms Reporting forms Others MDH Nonviable Vaccine Form MDH Vaccine Transfer Record and Vaccine Borrowing Report
bull MnVFC promotional materials bull Immunization Billing Guidance for MnVFC and Immunization Billing Guidance for MnVFC Replacement Sites Immunization Practices Improvement Program (IPI) wwwhealthstatemnusdivsidepcimmunizeipi
bull IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml) bull IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml) IPI Resource Folder Contents (wwwhealthstatemnusdivsidepcimmunizeipiipifolderpdf)
Minnesota Immunization Information Connection (MIIC) wwwhealthstatemnusmiic
bull MIIC regions and regional coordinators
Clinical Practice MDH Immunization Program wwwhealthstatemnusimmunize
Got Your Shots News wwwhealthstatemnusdivsidepcnewslettersgys
MDH Immunization Information for Health Care Providers wwwhealthstatemnusdivsidepcimmunizehcp
bull Got Your Shots A Providers Guide to Immunization in Minnesota bull Vaccine protocols bull Forms for tracking patient immunizations bull Immunization schedules for Health Care Providers Immunization Action Coalition (IAC) wwwimmunizeorg
bull Ask the Experts bull VISs (Vaccine Information Statements and translations) bull Administration screening questions bull Medical management of vaccine reactions bull Order form for Californiarsquos Immunization Technique DVD Best Practices with Infants Children and Adults
Page 52 IPI Advisor Manual| February 2017
IPI Advisor Resource List Chapter 5
CDC ldquoPink Bookrdquo wwwcdcgovvaccinespubspinkbookindexhtml
CDC Advisory Committee on Immunization Practices (ACIP) wwwcdcgovvaccinesacip
CDC Vaccines and Immunizations wwwcdcgovvaccines
VAERS reporting httpvaershhsgovindex
Storage and Handling Got Your Shots Providers Guide ndash Managing Vaccine wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml
MnVFC Guide to Temperature Monitoring Devices wwwhealthstatemnusvfc
MDH Clinicianrsquos Vaccine Mishap Checklist wwwhealthstatemnusdivsidepcimmunizeipivaxchklstpdf
MDH Vaccine Storage Guide wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml
CDC Vaccine Storage and Handling Toolkit wwwcdcgovvaccinesrecsstoragetoolkit
You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Vaccine manufacturer phone numbers wwwcdcgovvaccinespubspinkbookdownloadsappendicesFcontact-info-manufactpdf
IAC Checklist for Safe Vaccine Handling and Storage wwwimmunizeorgcatgdp3035pdf
IAC Donrsquot Be Guilty of These Errors in Vaccine Storage and Handling wwwimmunizeorgcatgdp3036pdf
Additional Resources Print materials from MDH ndash order forms wwwhealthstatemnusdivsidepcimmunizeordermathtml
Vaccine Education Center ndash Childrenrsquos Hospital of Philadelphia wwwchopeduservicevaccine-education-centerhomehtml
California Department of Public Health ndash Interactive training on vaccine administration and storage and handling handout on transporting vaccine and how to package wwwezizorg
IPI Advisor Manual | February 2017 Page 53
IPI Advisor Resource List Chapter 5
CDC vaccine price list wwwcdcgovvaccinesprogramsvfcawardeesvaccine-managementprice-listindexhtml
Vaccine Information Statements (VIS) wwwcdcgovvaccineshcpvisindexhtml
CEU Opportunities CDC Immunization Education and Training wwwcdcgovvaccinesedindexhtml
Immunization You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Page 54 IPI Advisor Manual| February 2017
- Introduction
-
- Welcome to the Immunization Practice Improvement (IPI) Program
- Contact Information
-
- Chapter 1
- Requirements to Participate in the MnVFC Program
- Vaccines for Children Program
- Chapter 2
- Reimbursement for MnVFC Visits
- Types of Visits
- Your MnVFC Clinical CoordinatorPlanner
- New IPI Advisor Training Requirements
- Your Role as an IPI Advisor
- Reasons MDH Would Do All or Part of a Visit
- Chapter 3
- Future follow-up
- Conducting the Visit
- Preparing for the Visit
- Information for the Visit
- Site Visit Checklist
- Scheduling the Visit
- Chapter 4
- After the Site Visit
- MnVFC Provider Follow-up Plan
- MnVFC Site Visit Storage and Handling Per Unit Answer Sheet
- Section 6 Inventory
- Section 5 Storage amp Handling Site-Wide
- Section 4 Storage amp Handling Per Unit
- Section 3 Documentation
- Section 2 Eligibility
- Section 1 Provider Details
- The Site Visit Reviewer Legend
- MnVFC Site Visit Questionnaire
- Required Paperwork for Site Visits
- Chapter 5
-
Page 30 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
i
i i i - li i i i i i l
Section 4 Storage amp Handling Per Unit The goal of this section is to assess vaccine storage
2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet practices in each unit at the site MnVFC PIN ___________________
The 2017 MnVFC Storage amp Handling Per Unit Answer Sheet is a worksheet to document the answers to the questions in this section for each unit (combination or stand-alone) Fill in the answers to the questions in Section 4 on the answer sheet not in the questionnaire
The answer sheet has an abbreviated form of each question If you need further information on that question refer back to the full questionnaire Also if you find an area where the site is not meeting the requirements you will need to go back to that question on the 2017 MnVFC Site Visit Questionnaire to complete ldquoActions if Non- compliantrdquo section including the root cause analysis and follow-up sections If there is a problem in more than one unit make a note on the questionnaire which unit you are referring to in the Notes section
Important You must fully assess any unit that may be used to store VFC vaccines even if there are no VFC vaccines there on the day of the visit If there are no vaccines and the site is not documenting twice a day temperatures discuss the need to ensure the unit is maintaining stable temperatures by monitoring for one week before placing vaccines in the unit
Quest on number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
for the freezer and e co umn
Temperature Monitoring Dev refr gerator f the un
ce Quest ons Quest ons 4 3 4 7 must be answered separate y t s a combo Be sure to document responses n the appropr at
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
44D Data downloaded and reviewed routinely (eg weekly)
Yes No [O]
Yes No [O]
45A Certificate of Calibration Testing Yes No [X]
Yes No [X]
45B Date of calibration
45C Date certificate expires [X] Follow-up is required if expired [X] Follow-up is required if expired
45D Certificate contains all necessary items
Yes No [X]
Yes No [X]
46 Probe properly placed Yes No [X]
Yes No [X]
47A Two temperature readings per day
Yes No [X]
Yes No [X]
47B Time date and name (or initials) for each reading
Yes No [X]
Yes No [X]
47C Current temperature and minmax temperatures (if
Current ________deg Minimum ________deg Maximum _deg
Current ________deg Minimum ________deg Maximum _deg
Sections 5 and 6 contain questions about storage and handling site wide and inventory It is helpful to keep those questions in mind as you assess the individual storage units Think about dorm-style units expired vaccine vaccine supply room for vaccine stocking all the recommended vaccines and separation of stock if appropriate
NOTE The sections that follow require reviewers to validate responses by looking at vaccine storage units temperaturemonitoring equipment and the vaccine inventory inside a unit bull For section 4 use a separate Storage amp Handling Per Unit Answer Sheet for each unit to document the findings (combination
units using both sections can be documented on the same answer sheet) bull When an unmet requirement is identified return to this questionnaire to complete the ldquoActions if Non-compliantrdquo section for
that question bull After you complete one answer sheet for each unit return to the questionnaire to complete sections 5 and 6 using information
you gathered while assessing the units The questions in sections 5 and 6 (Storage amp Handling Site-Wide and Inventory) are notunit-specific but do require that the response be based on a thorough assessment of all the providersrsquo units
4 Storage amp Handling Per Unit
Description On the Storage amp Handling Per Unit Answer Sheet place a name that will allow you or someone else from your program to easily identify this unit in the event of follow-up We recommend using Brand + Location(example Samsung - Room 123) Save each Storage amp Handling Per Unit Answer Sheet with the Brand + Location in the file name
(example SamsungRoom123doc)
IPI Advisor Manual | February 2017 Page 31
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 41
4 Storage amp Handling Per Unit Storage Unit Build amp Use
Question 41 Below select the build and use of the vaccine storage unit you are assessing
Note to Reviewer Dorm-style units Do not add dorm-style units here Dorm-style units will be addressed in section 5 Units storing only private stock You must review these storage units even if they contain only private stockat the time of the visit because that vaccine could be administered to VFC patients
A What type of unit is this A Stand-alone B Combination
B Select use if stand-alone A Freezer B Refrigerator
Select use if combination A Use both sections to store vaccine B Use freezer section only to store vaccine C Use refrigerator section only to store vaccine
Goal of this question Identify the unit you are evaluating The description asks you to create a unique name for this unit so that you will be able to identify the same unit in future site visits Put this description on the top of the answer sheet (ie make and location)
Helpful information bull A stand-alone unit is either a refrigerator or a freezer It does not have both sections in the unit bull If there is a combination unit note if the site uses both the refrigerator and freezer or only one section of the unit to store vaccines CDC does not recommend the use of either section or the freezer section only of combination household units
bull If your site utilizes the separate stock method of vaccine management you must review storage units even if they contain only private stock at the time of the visit because there is a chance that those vaccines could be administered (borrowed) to VFC-eligible patients
Page 32 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 424 Storage amp Handling Per Unit CDC Recommended Storage Units
Question 42 Below document the grade of the vaccine storage unit you are assessing
Note to Reviewer Pharmaceutical Also called ldquopurpose-builtrdquo these units are designed by the manufacturer specifically tostore vaccines or other biological materials Commercial Although usually intended to store food and beverages commercial units are often larger and more powerful than the household units found in most homes Though these units are intended to meet thehigher demands of larger facilities these units are not specifically built for the storage of biologicalmaterials Household (non-commercialdomestic) These units are usually smaller than commercial units and areintended for use in small offices and in homes ndash typically for food storage However just like commercialunits they are not designed specifically for the storage of biological materials Such units are usually available in common home supply stores
Answers (Choose one)
Select grade A Pharmaceutical B CommercialHousehold
[O] CDC does not recommend the use of both sections or the freezer section only of combination commercialhousehold units
Review CDC Recommendation
CDC recommends the following vaccine storage unit types (in order of preference) pharmaceutical grade stand-alone orcombination units (preferred) householdcommercial stand-alone units householdcommercial combination units using therefrigerator section only
Goal of this question Assess the grade and type of each storage unit bull Pharmaceutical grade units may be stand-alone or combination units that are often metal may have glass in the door for viewing inside often have an external digital temperature display and are manufactured by medical companies
bull Commercial or household units often look like your kitchen appliance have vegetablemeat drawers in the unit and are manufactured by household appliance companies
bull Occasionally you might find a medical grade unit which is usually a commercialhousehold unit with a lock and 3-prong plug These are still considered household units because of their ability to maintain proper temperatures and air flow Studies show that household stand-alone units are better able to maintain consistent temperatures than their combination counterparts Combination household units used to store vaccine in both sections of the unit is no longer recommended and may be prohibited in the future Combination household storage units that are having difficulty maintaining a cold enough freezer temperature and a warm enough refrigerator temperature should be replaced or a separate stand-alone freezer should be purchased
For frozen vaccines the most cost effective solution is for the site to purchase a small stand-alone freezer The site may need time to budget for a stand-alone storage unit
Resources bull Replacing Combination Household Units Tip Sheet on IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml)
IPI Advisor Manual | February 2017 Page 33
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 434 Storage amp Handling Per Unit Temperature Monitoring Device in the Unit
Question 43 Determine whether there is a temperature monitoring device in this section of the storage unit andanswer the questions
A Is there a temperature monitoring device in this section of thestorage unit
Yes No [X] (If no skip to question 47)
B Who is responsible for supplying the temperature monitoring device in this section of the storage unit Provider
Review CDC Requirement
Certificates of calibration testing provide confidence that the temperature monitoring device is measuring temperaturesaccurately All units storing VFC vaccines must have a calibrated temperature monitoring device with a current and valid certificateof calibration testing All certificates must contain modeldevice name or number serial number date of calibration testing (report or issue date) and Instrument Passed testingInstrument in Tolerance (Recommended uncertainty = +-05ordm C (+-1ordm F))
Goal of this question Assess whether there is a temperature monitoring device in the unit If the unit is not being monitored at all call MDH at 651-201-5522 for guidance
Helpful information bull This question does not ask whether the temperature monitoring device is working or the characteristics of the device These issues will be addressed later in the questionnaire
bull For part B the provider is always responsible for supplying the temperature monitoring device Even if their thermometer or data logger was originally from MDH it is their responsibility to ensure it is functional and calibrated
Resources bull Section 8 in the MnVFC Policies and Procedures Manual
Page 34 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 444 Storage amp Handling Per Unit CDC Recommended Temperature Monitoring Device
Question 44 Assess the temperature monitoring device in this section of the storage unit to answer the questionsbelow
A Is the temperature monitoring device a continuous monitoring and recordingdevice (eg data logger)
Yes No [O] (Skip D)
B Does the temperature monitoring device have a probe in buffered material Yes No [O]
C Does the temperature monitoring device have a digital display that can beeasily read from the outside of this unit
Yes No [O]
D Is data downloaded and reviewed routinely Yes No [O]
Review CDC Recommendation
As of Jan 1 2018 all VFC providers must use continuous temperature monitoring devices (eg data loggers) to monitor vaccinesthat will be administered to VFC-eligible children Routine review and accessibility of temperature data is critical for determining whether vaccine has been properly stored and for assessing usability of vaccine that was involved in a temperature excursion Tomeet VFC Program requirements the device must also be equipped with bull A temperature probe bull An active temperature display that can be easily read from the outside of the unit bull The capacity for continuous monitoring and recording capabilities where the data can be routinely downloaded
The following are additional recommended features for these devices bull Alarm for out-of-range temperatures bull Current minimum and maximum temperatures display bull Low battery indicator bull Accuracy of +- 1degF (05degC) bull Memory storage of at least 4000 readings bull User programmable logging interval (or reading rate) recommended at a maximum time interval of every 30 minutes bull Use of a probe that best reflects the temperature of the vaccine (such as a buffered probe)
Goal of this question Assess the temperature monitoring device in the storage unit Note that these are all recommendations not requirements at this time
This is a great teaching opportunity for sites who do not currently have a continuous temperature monitoring device Beginning Jan 1 2018 all units that store MnVFC vaccine will be required to have a continuous temperature monitoring device (ie a data logger or a continuous temperature monitoring system) Unlike a minmax thermometer a continuous temperature monitoring device provides detailed information on all temperatures recorded at pre-set intervals For excursions it can provide information on when a temperature went out-of-range for how long and what the temperatures were This is essential information that vaccine manufacturers need to know to assess the viability of the vaccine following an excursion
Helpful information bull Sites are required to monitor and record temperatures twice daily however temperature excursions can easily occur in the 12 hours or longer between readings Continuous temperature monitoring can help manufacturers determine vaccine viability
bull Continue to encourage sites to document and evaluate minimum and maximum temperatures the storage unit reached since the last reading and respond appropriately to out-of-range temperatures
IPI Advisor Manual | February 2017 Page 35
The 2017 MnVFC Site Visit Paperwork Chapter 4
bull It is recommended that sites download and review data weekly Discuss with sites that reviewing temperature monitoring device data also includes responding appropriately if they identify out-of-range temps
bull There is sometimes confusion about the difference between a data logger and a continuous temperature monitoring system Here are some differences
Data Loggers Continuous Monitoring Systems Have an external display similar to thermometers May or may not have an external display Have a detachable probe Probe is usually attached to transmitter Need to be plugged into the computer or cradle to download information on a regular schedule
Wirelessly sends data to computer system
Create a file of data that needs to be saved on the computer
Data is stored within the system not a separate file
Doesnrsquot allow documentation of twice a day temperature checks in the file
May allow documentation of twice a day temperature checks within the system
More about the 2018 requirement for a continuous temperature monitoring device
Required Features bull The continuous temperature monitoring device must have Continuous monitoring and recording capabilities to track and record temperatures over time The capacity to routinely download temperature data to a computer (recommended at least weekly) or wirelessly transmit data Detachable probe in a bottle filled with a thermal buffer (eg bio-safe glycol) if the data logger needs to be detached in order to download data Active temperature display
Recommended Features bull MnVFC recommends continuous temperature monitoring devices with Alarm for out-of-range temperatures Accuracy within +-1degF (+- 05degC) Low battery indicator Display of current minimum and maximum temperatures Memory storage of at least 4000 readings User programmable logging intervals (eg the user can set how often the device records the temperature)
Note that these are all currently recommendations not requirements yet
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Page 36 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 45
Goal of this question Ensure the temperature monitoring device is properly calibrated The certificate of calibration testing means that the device has been tested and it is accurately measuring temperatures within established testing limits The certificate of calibration ensures that the device meets all the required components
Helpful information bull The provider is always responsible for having a current certificate of calibration (or copy) on-site
bull To be considered ldquovalidrdquo a certificate of calibration must contain these required elements Modeldevice name or number Serial number
4 Storage amp Handling Per Unit Certificate of Calibration Testing
Review CDC Requirement
Certificates of calibration testing provide confidence that the temperature monitoring device is measuring temperaturesaccurately All units storing VFC vaccines must have a calibrated temperature monitoring device with a current and valid certificateof calibration testing All certificates must contain modeldevice name or number serial number date of calibration testing (report or issue date) and Instrument Passed testingInstrument in Tolerance (Recommended uncertainty = +-05ordm C (+-1ordm F))
Question 45
Note to Reviewer
A
B
C
D
E
Review the certificate of calibration testing for the temperature monitoring device in this section of the storage unit and answer the questions below
bull How to determine certificate of calibration testing expiration date 1) Identify the certificate issuecalibration date 2) Apply the Immunization Program-required frequency for calibration testing Example If the
issuecalibration date is 12312013 and Immunization Program policy requires testing every twoyears the expiration date is 12312015
bull Certificates must include all of the below bull ModelDevice Name or Number bull Serial Number bull Date of Calibration Testing (Report or Issue Date) bull Instrument Passed testing (Instrument in Tolerance)
Is there a certificate of calibration testing for the temperature monitoring Yes device in this section of the storage unit No [X]
What is the date of calibration for the temperature monitoring device in this section of the storage unit
What is the certificatersquos date of expiration based on ImmunizationProgram policy (See note to reviewer to determine expiration date) [X] Follow-up is required if
certificate is expired
Does the certificate contain all the necessary items listed in the Note to Yes Reviewer No [X]
Who is responsible for supplying the current and valid certificate of Provider calibration for this temperature monitoring device
Date of calibration testing (report or issue date) Note If there is no expiration date the certificate expires 2 years from the date of calibration Whether the instrument passed or failed testing (or instrument in tolerancenot in tolerance)
bull Recommended element Documented uncertainty of +- 1degF [05degC]
If these elements are present the certificate is considered valid If the certificate contains information about the recommended element or the entity that issued the certificate that is helpful but not required
To determine if a certificate of calibration testing was issued by an appropriate entity check to see if the certificate indicates one or more of these items (this is the wording used to help sites evaluate if their calibration is accurate but is not required on the certificate itself to be considered valid)
bull Conforms to ISO 17025 bull Performed by an ILACMRA Signatory body accredited laboratory You can review this list of the ILAC MRA and Signatories (httpilacorgilac-mra-and-signatories)
bull Traceable to the standards maintained by NIST bull Meets specifications and testing requirements for the American Society for Testing and Materials (ASTM) Standard E2877 tolerance Class F (le 05 degC) or better
bull Includes reference to another acceptable accuracy validation method such as comparison to other traceable reference standards or tests at thermometric fixed points
Note CDC recommends that certifications be issued for the entire monitoring unit (detachable probe data logger etc) and not individual certificates for each component
IPI Advisor Manual | February 2017 Page 37
The 2017 MnVFC Site Visit Paperwork Chapter 4
For 45 E the provider is always responsible for supplying the current and valid certificate of calibration for a temperature monitoring device
bull Tip If the temperature monitoring device has a sticker on the back with the calibration date the site can usually call the company who calibrated the device and get a copy of the certificate if they donrsquot have one
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 46 4 Storage amp Handling Per Unit Probe Placement
Question 46 Is the probe properly placed in this section of the storage unit
Note to Reviewer ldquoProperlyrdquo means that the probe in a commercial or household unit is placed in a central area of the unitdirectly with the vaccines Probes should not be placed in the doors near or against the walls close to vents or on the floor of the unit The only allowable exemption related to this requirement is for providerswho have pharmaceutical storage units (built for vaccine storage) that have either (1) a built-intemperature monitoring device OR (2) a dedicated port for the probe that dictates the placement of theprobe
Answers (Choose one)
Yes No [X]
Review CDC Requirement
The probe must be placed in a central area of the section of the storage unit directly with the vaccines in order to properly measurevaccine temperature The probe should not be placed in the door near or against the walls close to vents or on the floor of theunit For pharmaceutical units with a built-in temperature monitoring device or a dedicated port for a probe that is not in thecenter of the section of the storage unit consult your Immunization Program for guidance on placement
Goal of this question Make sure the temperature monitoring device is in the best location to accurately measure the temperature of the vaccines stored in the unit
Helpful information bull The probe of the temperature monitoring device should be placed directly with the vaccines in the middle of the unit The ONLY allowable exception is for pharmaceutical storage units that have either a built-in thermometer or a dedicated port for the probe that indicates placement of the probe
bull Temperatures can vary within the unit especially household units bull Call MDH at 651-201-5522 if you have questions
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Guide (wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml)
Page 38 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 474 Storage amp Handling Per Unit Temperature Documentation
Question 47 Review the temperature documentation over the past three months for this section of the storage unit todetermine whether the provider has a process in place for properly documenting temperatures twice aday Answer the questions below
A Are there two temperature readings recorded for this section of the storage unit per day
Yes No [X]
B Is there a time date and name (or initials) recorded for each reading Yes No [X]
C What is the current temperature and minmax temperatures (if available) inthis section of the storage unit Use the reviewerrsquos thermometer if the providerrsquos temperature monitoringdevice does not have a current valid certificate of calibration testing or the probe is not properly placed in this section of the storage unit
Current Temperature Minimum Temperature Maximum Temperature Fahrenheit Celsius
D Based on your review of the providerrsquos recent temperature documentationincluding the current temperature is this section of the storage unitmaintaining appropriate temperatures
Yes No [X] Not enough information [X]
Review CDC Requirement
Vaccines must be stored under appropriate temperatures as described in the package inserts at all times Acceptable temperature ranges vary by vaccine type and the range is 36deg F and 46deg F (2deg C and 8deg C) and for frozen vaccines the range is -58deg F and +5deg F (shy50deg C and -15deg C) Exposure to temperatures outside of those included in the package inserts could affect vaccine viability andultimately could leave children unprotected against vaccine-preventable diseases In order to maintain awareness of storage unittemperatures and ensure that vaccines are being stored at appropriate temperatures at all times VFC providers are required to monitor and document temperatures for all vaccine storage units at least twice a day Temperature documentation must contain (1) at least two temperature readings per day (2) the time and date of each reading and (3) the name (or initials) of the personwho assessed and recorded the readings CDC also recommends that VFC providers record the minimum and maximumtemperatures of each unit once each workday (preferably in the morning)
Goal of this question Ensure the temperature is being monitored twice daily is within the required range and documented correctly Use your thermometer to check the temperature if the sitersquos temperature monitoring devicersquos probe is not properly placed or there is not a current certificate of calibration Place your thermometer in the unit at the beginning of the visit to allow sufficient time to reach an accurate temperature The purpose of using your thermometer is to ensure the vaccine is being stored at the proper temperature not to ldquovalidaterdquo their reading
Question 47 D is an assessment question based on information you have learned during your visit You might answer ldquonot enough informationrdquo if the unit is new and they donrsquot have at least three months of data or if the unit is only used as overflow and they are inconsistent with temperature monitoring Mark ldquoNordquo if you have reason to believe the storage unit is not maintaining temperatures properly
Helpful information bull All sites must document temperatures twice a day every day the site is open even if they have a data logger or continuous monitoring system
bull Sites can document the information electronically with some continuous monitoring systems as long as it can show what the current temp is the date time and initials of the person checking ndash this needs to be someone at the site ndash not checking remotely or centrally for a large site or system The site must be able to produce these records during their site visit Reviewing these files can be a challenge due to large volumes and lots of paper
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Temperature Logs on Managing Vaccine (wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml)
IPI Advisor Manual | February 2017 Page 39
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 484 Storage amp Handling Per Unit Temperature Excursions
Question 48 In the event that a temperature excursion(s) occurred in this unit within the last three months requestand review documentation of actions taken to determine whether the provider has a process for properlyaddressing excursions Answer the questions below
A Were vaccines in this unit exposed to out-of-range temperatures in the lastthree months (including today)
Yes No (If no skip to question 49)
B Did the provider quarantine and label vaccines as ldquoDo not userdquo Yes No [X]
C Did the provider place vaccine in a unit where it can be stored under properconditions if applicable
Yes No [X]
D Did the provider contact the Immunization Program to report theexcursion
Yes No [X]
E Was the manufacturer contacted for documentation supporting theusability of the vaccine
Yes No [X]
Review CDC Requirement
The provider must document all excursions and actions taken including the following (1) Quarantine and label vaccines as ldquoDO NOTUSErdquo (2) Place vaccines in a unit where they can be stored under proper conditions (3) Contact the Immunization Program to report an excursion and (4) Contact the vaccine manufacturer to obtain documentation supporting the usability of the vaccine
Goal of this question Address any out-of-range temperatures (temperature excursions) identified in reviewing the last three months of temperature logs or during the site visit If there were any out-of-range temperatures did the site respond appropriately to the situation This is a great opportunity to discuss what to do in the event of an excursion The Clinicians Storage and Handling Mishap Checklist is in the IPI Site Visit information folder and is a good review of the process
Helpful information bull Sites need to know that an excursion does not automatically mean that exposed vaccines are non-viable or unusable Exposed vaccines must be quarantined (marked ldquoDo Not Userdquo) and stored under proper conditions until they have received information from vaccine manufacturers regarding the viability of the vaccine
bull Sites must inform MDH when an excursion occurs
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Clinicians Storage and Handling Mishap Checklist (wwwhealthstatemnusdivsidepcimmunize ipivaxchklstpdf)
Page 40 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 49
Goal of this question Ensure proper placement of vaccines in the storage unit
Note These are all recommendations (best practices) not requirements
Helpful information bull Store vaccine in the middle of the compartment two to three inches away from the coils walls floor and cold air vent The temperature near the floor and walls of the unit differs from that in the middle of the compartment and the cold air vent can freeze refrigerated vaccines
4 Storage amp Handling Per Unit Vaccine Placement
Question 49 Look inside the unit to answer the questions below
A Are vaccines placed in the middle of the unit with space between vaccinesand the sideback of the unit to allow cold air to circulate
Yes No [O]
B Are vaccines stored in their original packages Yes No [O]
C Are there water bottles (for refrigerators) or frozen water bottles (forfreezers) in the unit
Yes No [O]
D Are vaccines store in the doors vegetable bins under or near cooling ventsor on the floor of the unit
Yes [O] No
E Is food being stored in the unit Yes [O] No
Review CDC Recommendation
Vaccines should be stored in their original manufacturer (or CDC centralized distributor) packaging They should be placed in the middle of the unit with space between the vaccines and the sideback of the unit to allow cold air to circulate Vaccines SHOULD NOT be stored in the doors vegetable bins or floor of the unit or under or near cooling vents and there should not be any food inthe unit Water bottles (for refrigerators) or frozen water bottles (for freezers) should be placed throughout each storage unit inorder to (1) stabilize or extend temperatures during a power outage and (2) to serve as physical blocks preventing the placementof vaccines in areas of the unit that are at higher risk for temperature excursions (such as in doors vegetable bins floor ornearunder cooling vents)
bull Vaccines should be kept in their original packaging to Protect them from light Help prevent medication errors by making labels easier to read Provide a moisture barrier that serves as insulation in case of an out-of-range temperature power outage door left open or mechanical failure Simplify managing vaccine inventory
bull Store water bottles in the doors on the floor and near the cold air vent in the refrigerator and frozen water bottles in the freezer to help maintain a stable temperature if there is a power failure and when the door is opened frequently Too many water bottles in the door can prevent the door from closing tightly Mark water bottles ldquoDo Not Drinkrdquo
bull Do not store vaccine in the door or drawers of the refrigerator or freezer Vegetable bins and crisper drawers should be removed from refrigerators or used to store other medical supplies or water bottles
bull If vaccine is stored in a household combination refrigeratorfreezer The top shelf should not be used for storing vaccine because the cold air vent blowing from the freezer will freeze vaccine located there If you must use the top shelf of this type of unit place water bottles underneath the cold air vent to prevent vaccine from being stored there It is recommended that only the refrigerator be used for vaccine storage and a separate stand-alone freezer be used to store frozen vaccine
bull Must not store food or beverages in the refrigerator or freezer because frequent opening of doors can lead to temperature variations that may affect vaccine viability There is also a risk of contaminating vaccines
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Guide (wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml) bull Vaccine Storage Tip Sheet on IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml)
IPI Advisor Manual | February 2017 Page 41
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 4104 Storage amp Handling Per Unit Disconnection from Power Source
Question 410 Ask the provider to demonstrate what measures are taken to ensure that vaccine storage units are notaccidentally physically disconnected from the power supply Which of the following describes the measure(s) taken on this unit
Note to Reviewer bull Large hospitals and healthcare systems may not have the ability to demonstrate labels on plugs or circuitbreakers In such cases verify that the practice has a comprehensive policy and standard operatingprocedures in place to prevent the vaccine storage unit from being physically disconnected from thepower supply
bull While back-up generators may ensure power to the overall facility this question ONLY addresses thevaccine storage unit being accidentally disconnected from the power source either through the plug orthe circuit breaker
Answers A ldquoDo not disconnectrdquo labels on the plug (Choose all that B ldquoWarningrdquo label on the circuit breaker box
apply) C Hard-wired (ie built-in) and has a ldquoDo not disconnectrdquo label on thecircuit breaker box D Hospital or large health care system with a comprehensive written policyand standard operating procedures detailing measures taken to preventvaccine storage units from being accidentally disconnected from the powersupply E No acceptable measures for preventing accidental disconnection frompower supply [X]
[X] The response is non-compliant if only A only B or E is selected
Review CDC Requirement
VFC providers must take steps to protect the power source for all vaccine storage equipment by means of having clear warninglabels on both the plug and the circuit breaker associated with all vaccine storage units Large hospitals and healthcare systems canmeet this requirement by demonstrating that they have comprehensive policies and standard operating procedures to preventvaccine storage units from being physically disconnected from the power supply
Goal of this question Decrease the chance that a vaccine storage unit will be accidently unplugged or power will be turned off while vaccine is in the unit This question addresses only what measures the site has taken to ensure the storage unit is not physically disconnected from its power source
If the site uses labels on the plugs and circuit breakers perform a visual inspection to assess whether the way the stickers are positioned make it clear and obvious to anyone that these units are not to be disconnected
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Do Not Unplug and Warning stickers are included in the folder or available to order on the For
Professionals Order Form (wwwhealthstatemnusdivsidepcimmunizeordermathtml)
Note Once you have completed the 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet for each unit return to the questionnaire to complete sections 5 and 6
Page 42 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
- -
Section 5 Storage amp Handling Site-Wide Question 51
5 Storage amp Handling Site Wide Discussion of Cost amp Quantity of Vaccine
Question 51 Have a discussion with the provider about the cost and quantity of VFC vaccines they are responsible for annually Address the points listed in the note to reviewer below
Note to Reviewer bull Vaccine Shipped (Required) Share the cost of VFC vaccines shipped to the provider in the last calendaryear to make sure the provider understands the contribution made by the VFC Program to their practiceFor new providers who do not have ldquocalendar yearrdquo data share either the actual cost of their currentinventory or use the cost of 10 VFC doses of each of the ACIP-recommended vaccines (approximately $7000) to help estimate their annual cost
bull Storage amp Handling (Required) Make sure the provider understands the cost of vaccines for which they are responsible when they make decisions about purchasing recommended vaccine storage and temperature monitoring equipment
Answer I have discussed with the provider the cost and quantity of vaccines ordered in the previous calendar year
Goal of this question Inform sites of the quantity and value of vaccines that they receive as part of the MnVFC program Providers often donrsquot realize the value of the vaccine in their unit This information is included on your clinic list and on the one page site-specific information
Helpful information bull This discussion must occur and the box on the questionnaire must be checked bull If there isnrsquot actual vaccine value information available tell the site that one vaccine order that includes a box of each of the ACIP recommended vaccines costs approximately $7000
bull MDH may not have specific information for individual sites if they receive vaccine from a central warehouse or pharmacy For those sites MDH will give you numbers for the whole system so you can discuss system wide data as appropriate If individual site information is also included it is usually just varicella-containing vaccines that must be shipped directly to the site
Question 52
5 Storage amp Handling Site Wide Dorm Style Units
Question 52 Determine whether the provider has any dorm-style units on site and answer the questions below
Note to Reviewer A dormitory-style refrigerator is a unit that has both refrigerator and freezer compartments behind a singleexterior door Dorm-style units also have an evaporator plate (cooling coil) which is usually located insidean icemaker compartment (freezer) within the refrigerator
A Does the provider have any dorm-style units that are used at any time tostore vaccines
Yes [X] No (Skip to question 53)
B Does the provider have sufficient space in existing compliant vaccinestorage units to store all vaccines without use of the dorm-style unit at any time
Yes No [X]
Review CDC Requirement
Dorm- and bar-style units are prohibited for vaccine storage Vaccines stored in dorm-style units are considered non-viable and must be returned to the centralized distributor CDC recommends the following vaccine storage unit types (in order of preference)pharmaceutical grade stand-alone or combination units (preferred) householdcommercial stand-alone unitshouseholdcommercial combination units using the refrigerator section only
Goal of this question Ensure no vaccine is stored in dorm-style units even for short periods of time Encourage them to label any units ldquoNo Vaccine Storage Allowedrdquo Vaccine stored in these units is considered non-viable If a site is using a dorm-style unit call the MnVFC program (651-201-5522)
Resource Section 8 in the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 43
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 535 Storage amp Handling Site Wide Storage Unit Space Availability
Question 53 Does the provider have sufficient room across storage units to store current stock as well as anyadditional stock acquired during peak season without overcrowding
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have sufficient storage space to accommodate vaccine stock at the busiest time of year without overcrowding
Goal of this question Ensure that sites have sufficient space in their units to maintain vaccines at the busiest time of year Overcrowding of vaccine limits air circulation and affects the unitrsquos ability to maintain stable temperatures
Helpful information bull Look for signs of overcrowding such as vaccines that are pushed up against the wall bins that are overflowing or storage units that are full during non-peak seasons
Discuss immediate actions if the unit is overcrowded Move some of their vaccines order less vaccine more frequently (once per month preferably) andor purchase another storage unit for overflow
Resource bull Section 8 MnVFC Policy and Procedure Manual
Page 44 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 545 Storage amp Handling Site Wide Expired Vaccines
Question 54 Look in each unit Are there expired vaccines in any of the vaccine storage units at this site
Answers (Choose one)
Yes [X] No
Review CDC Requirement
Vaccines should be rotated weekly and when a new shipment comes in so that longer-dated vaccines are stored behind shorter-dated vaccines If vaccines expire they can no longer be stored in the same storage unit with viable vaccines They must be placedin a container or bag clearly labeled ldquoDo not userdquo and separated from viable vaccines to prevent inadvertent use Expired vaccinemust be returned to the centralized distributor within six months of expiration
Goal of this question Ensure there is no expired vaccine in any storage unit
Helpful information bull Sites can prevent their stock from expiring by rotating vaccines every week andor when a new shipment arrives Longer-dated vaccines are stored towards the back of the unit and shorter-dated vaccines are up front
bull Pay attention to vaccines that expire within the next three months Consider transferring vaccine that will expire soon to another MnVFC-enrolled site that will use the vaccine preferably a site close by It is the transferring sitersquos responsibility to arrange the transfer of the vaccine Be sure to complete the MDH Vaccine Transfer Record form and send it to MDH If they are having difficulty finding a location to accept vaccine contact MDH
bull This is a great opportunity to educate sites about the MDH Nonviable Vaccine Form and the process for returning vaccine The VFC program does get some credit for taxes and fees on vaccine that is returned to the distribution center
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MDH Nonviable Vaccine Form and MDH Vaccine Transfer Record on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfcformshtml)
IPI Advisor Manual | February 2017 Page 45
The 2017 MnVFC Site Visit Paperwork Chapter 4
- -
-
Question 555 Storage amp Handling Site Wide Back up Thermometer
Question 55 Does the provider have a readily available back-up thermometer with a current and valid certificate ofcalibration testing
Note to Reviewer ldquoReadily availablerdquo means that the thermometer is available to perform twice-a-day monitoring for a unit asrequired CDC recommends that the back-up thermometer be maintained on site
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have a readily available back-up thermometer with a current and valid certificate of calibration testing Toprevent the certificates of calibration testing of the primary and back-up thermometers from expiring at the same time the date of calibration testing (or issue date) of the back-up thermometer should be different from the date of calibration testing (or issue date) of the primary thermometer As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meetsVFC program requirements
Goal of this question Ensure sites have one calibrated back-up thermometer onsite that is readily available in the event that the temperature monitoring device in unit fails transportation of vaccine is needed or there are other unexpected circumstances
Helpful information bull As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meets VFC Program requirements
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 56 5 Storage amp Handling Site Wide Preparation of Vaccine
Question 56 When does this provider prepare vaccine for administration to the patient
Note to Reviewer For mass vaccination clinics if one type of vaccine is offered providers may pre-draw up to 10 doses Ifusing pre-filled syringes pre-drawing also means activating the syringe by removing the needle guard orattaching a needle
Answers (Choose all that
apply)
Prepare dose immediately before administration Pre-draw doses for upcoming patients (in a regular clinicpractice) [O] Pre-draw up to 10 doses (in a mass-vaccination clinic) Pre-draw more than 10 doses (in a mass-vaccination clinic) [O] Other [O]
Review CDC Recommendation
CDC recommends preparing vaccines immediately prior to administration in order to assure viability of vaccine and prevent vaccinewastage Vaccines that are not administered immediately are at risk of exposure to temperatures outside of the required rangewhich can affect vaccine viability and ultimately can leave children unprotected against vaccine-preventable diseases
Goal of this question Discuss proper timing and preparation of vaccine(s) for administration These are recommendations not requirements
Helpful information bull Educate staff on the importance of preparing vaccine immediately before administration Pre-drawing of vaccines may lead to concerns related to vaccine viability potency sterility and wastage
Page 46 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 6 Inventory Question 61
6 Inventory Inventory Comparison
Question 61 Visually inspect storage units to determine if existing supply of vaccines proportionately mirrorspopulations served Choose the most accurate statement below
Note to Reviewer bull CDC recommends that providers maintain a four-week supply of inventory bull For this question do not take into account vaccine types that the provider does not order Here simply
make sure that overall the vaccines in the providerrsquos storage units are available in sufficient amounts toserve their patient population
Answers (Choose one)
The current vaccine inventory proportionately reflects the populations identified Only public stock is insufficient [X] Only private stock is insufficient [X] Both public and private stock are insufficient [X] Site uses the replacement method but does not appear to have enough vaccine for their population [X] Other [X]
Review CDC Requirement
VFC providers must order and stock routine vaccines in accordance with their patient population in order to prevent missedvaccination opportunities Having sufficient amounts of all stocks prevents the inadvertent use of VFC vaccines for non-VFC-eligiblepatients and vice versa
Goal of this question Assess whether the site is ordering appropriate quantities of vaccine for the population they serve at their site
Helpful information bull If the site sees 30 percent private-pay patients and 70 percent VFC the stock in their storage units should reflect that proportion If you donrsquot know you can ask the site about their population
bull This is meant to be a general assessment so in a big site if they have only a small amount of vaccine that may indicate an issue with vaccine management
bull CDC recommends smaller more frequent orders (ie monthly) rather than large orders to minimize the amount of vaccine loss if an incident occurs during shipment or in the storage unit Sites should not order more frequently than once a month
bull Sites using the replacement method will only have one stock but it should appear to be large enough for their population
bull Only assess the vaccine types that the site currently stocks in their unit We know there are sites that do not offer all ACIP-recommended vaccines for various reasons That issue will be addressed in question 62
IPI Advisor Manual | February 2017 Page 47
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 626 Inventory ACIP Recommended Vaccines
Question 62 Review providerrsquos current inventory to answer the questions below
A Does the provider offer all routine ACIP-recommendedvaccines for their patient population
Yes (Skip to question C) No [X] Offers all except varicella because direct ship ofvaccine is unavailable from manufacturer
B Which routine vaccines are NOT being offered DTaP Hepatitis A Hepatitis B HIB HPV Influenza Meningococcal
MMR Pneumococcal Polio Rotavirus TdapTd Varicella
C According to Immunization Program Policy does theprovider make accessible all non-routine ACIP-recommended vaccines for those VFC patients whomeet the criteria for receiving them
Yes (Skip to question 63) No [X]
D Which non-routine vaccines are NOT being offered Pneumococcal polysaccharide vaccine (PPSV23) Meningococcal Group B (MenB) Other
Review CDC Requirement
VFC providers agree to comply with immunization schedules dosages and contraindications that are established by the Advisory Committee on Immunization Practices (ACIP) for the vaccines identified and agreed upon in the Provider Agreement UNLESS bull In the VFC providers medical judgment and in accordance with accepted medical practice the VFC provider deems such
compliance to be medically inappropriate for the child bull The particular requirements contradict state law including laws pertaining to religious and other exemptions The VFC program entitles children to the following vaccines DTaP Hepatitis A Hepatitis B HIB HPV Influenza MeningococcalMMR Pneumococcal Polio Rotavirus TdapTd and Varicella VFC providers are also required to ensure that VFC-eligible children have access to non-routine vaccines as needed
Goal of this question Assess if the site is offering all the ACIP-recommended vaccines for the population they serve and these vaccines are in stock on the day of the visit It is important that every MnVFC-eligible child that comes to a providerrsquos office for an immunization is vaccinated
Helpful information bull The Advisory Committee on Immunization Practices (ACIP) is a group of medical and public health experts that develops recommendations on how to use vaccines to control diseases in the United States
bull Specialty providers are not required to offer all routine vaccines but should provide the vaccines appropriate for their population
bull If the site does not offer all routine ACIP-recommended vaccines appropriate for their population check the ldquoNordquo box in Part A then check the appropriate box(es) in Part B for any vaccines not offered Please contact MDH as this situation offers us the opportunity to provide education to the site
bull For non-routine vaccines they must either be in stock or the site must have an alternative protocol in the routine management plan that ensures these children have access when applicable
Resources bull IAC Diseases and Vaccines (wwwimmunizeorgvaccines) bull CDC Advisory Committee on Immunization Practices (ACIP) (wwwcdcgovvaccinesacipindexhtml)
Page 48 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 636 Inventory Separation of Stock
Question 63 Observe how the provider differentiates stock in each storage unit to answer the questions below
A Is it clear which vaccines belong to public stock andwhich belong to private stock
Yes No [X] Not applicable replacement site
B Is it clear which vaccines belong to VFC stock andwhich belong to UUAV stock
Yes No [X] Not applicable replacement site Not applicable not UUAV-enrolled site
Review CDC Requirement
In order to ensure that VFC vaccines are only administered to VFC-eligible children VFC providers that serve both VFC and non-VFCshyeligible children must maintain their vaccine inventories in such a way that they can clearly differentiate public stock from privatestock as well as VFC from other public stock
Goal of this question Assess whether the site can distinguish between MnVFC vaccine and private vaccine If they participate in the Uninsured and Underinsured Adult Vaccine (UUAV) program they should also be able to distinguish between MnVFC stock and UUAV stock Some sites use labels bins boxes etc to differentiate their stock If it is not clear how the site differentiates their stock discuss vaccine management with the staff For follow-up call MDH to discuss doing a follow-up site visit
Sites using the replacement method will not have separate stocksmdashthis is an approved alternative method for keeping track of vaccine
Resource bull Section 10 of the MnVFC Policy and Procedure Manual
IPI Advisor Manual | February 2017 Page 49
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
MnVFC Site Visit Storage and Handling Per Unit Answer Sheet 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet MnVFC PIN ___________________
Question number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
Temperature Monitoring Device Questions Questions 43 47 must be answered separately for the freezer and refrigerator if the unit is a combo Be sure to document responses in the appropriate column
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
All the questions on the Site Visit Storage amp Handling Per Unit Answer Sheet have been discussed previously in section 4 of this manual Use this sheet to record information about all the units at the site visit You will need one sheet for each unit If it is a combination unit (either pharmaceutical or household) you can record both sections on one sheet If they have stand-alone units use one sheet for each unit Do not enter the answers to the questions in section 4 of the questionnaire
If you need more information about any of the questions refer back to the main questionnairemdashthe complete question additional guidance including notes to the reviewer and the CDC requirements are there Also if the site is not meeting the requirement you will go back to the questionnaire to complete the ldquoActions if Non-compliantrdquo section including the root cause analysis and follow-up sections
When you have completed the assessment of all the storage units remember to go back to the questionnaire to complete sections 5 and 6
Page 50 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
ndash
ndash
MnVFC Provider Follow-up PlanThe goal of the Provider Follow-up Plan is to communicate with the site all of the VFC requirements any unmet requirements found during your site visit and the timeline for completing the required action The left hand column is a box to check for ldquoUnmetrdquo requirements
Helpful information bull The form can be used to review what the site is doing well and what they need to work on
bull For requirements that have specific documentation that needs to be sent to you use the notes section
2017 MnVFC Provider Follow-up Plan Site _______________________________________________ MnVFC PIN ____________ Date of Visit ___________
Thank you for participating in this MnVFC compliance site visit Please review this visit summary including follow-up actions and timelines for completion Unmet MnVFC requirements and recommendations have a checked box next to them The goal of this plan is to support you with successfully implementing the program and improving access to vaccines for VFC-eligible children
Unmet Question VFC Requirements Section 1 Changes to Key Staff
Q12 Change in the Medical Director Immunization Manager Vaccine Coordinator or back-upKey Staff must be communicated to the immunization program by emailing healthmnvfcstatemnus Changes Notes
Q12 Key staff must complete the annual training on VFC program requirements and print theAnnual Training certificate of completion Documentation Required Action
Staff that have not completed the MnVFC online training must complete it and send acopy of the certificate to the reviewer Training can be found on the MnVFC website (wwwhealthstatemnusvfc) Due date 1 month
Notes
Unmet Question VFC Requirements Section 2 Eligibility
Q21 Provider staff must possess a working knowledge of all VFC eligibility criteria and use thoseVFC Eligibility criteria to screen children prior to administering VFC vaccines
Categories Notes
bull This form provides documentation needed for follow-up actions when you send your thank you email
The second to last page of the Provider Follow-up Plan has a summary of the MnVFC program recommendations These are to remind the site about best practices they may want to improve upon even though they are not yet requirements of the program For example you could discuss the recommendation about storage units if they currently have a combination household unit and are using both sections
The last section is for your signature and the person you met with In most sites it will be the immunization manager or vaccine coordinator who signs the form unless the medical director attended the site visit You keep the original copy and the site will need to keep a copy for themselves
To be completed by the site visit reviewer
I acknowledge that a VFC site visit was performed on __________________ (visit date) The follow-up plan which includes a list of all current VFC program requirements and recommendations assessed during the visit and any required follow-up actions was provided at the end of the visit
Site visit reviewer
Phone
Reviewer Signature Date
To be completed by the provider
I acknowledge that our practice took part in the VFC site visit noted above I understand the findings of the visit and any required actions that must be taken by our office in order to meet VFC program requirements
Medical Director (or designee) Name Title
Medical Director (or designee) Signature Date
IPI Advisor Manual | February 2017 Page 51
The 2017 MnVFC Site Visit Paperwork Chapter 4
After the Site Visit Send a thank you email highlighting the unmet requirements documents you need from the site to resolve the issue(s) and the date you need them Make sure to include the link to the Site Visit Survey (httpssurveyvovicicomseashxs=56206EE334CE0B14)
Please refer to Chapter 3 for more information about future follow-up required after the visit including forms and documentation
Resource bull Sample Thank You letter on IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml)
Chapter 5
IPI Advisor Resource List MnVFC Program 651-201-5522
MnVFC wwwhealthstatemnusvfc
bull Separate Stock and Replacement Method Policies and Procedures Manuals bull Online trainings bull MnVFC Announcements sign up to receive them via email bull Ordering MDH vaccine bull MnVFC forms Screening forms Reporting forms Others MDH Nonviable Vaccine Form MDH Vaccine Transfer Record and Vaccine Borrowing Report
bull MnVFC promotional materials bull Immunization Billing Guidance for MnVFC and Immunization Billing Guidance for MnVFC Replacement Sites Immunization Practices Improvement Program (IPI) wwwhealthstatemnusdivsidepcimmunizeipi
bull IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml) bull IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml) IPI Resource Folder Contents (wwwhealthstatemnusdivsidepcimmunizeipiipifolderpdf)
Minnesota Immunization Information Connection (MIIC) wwwhealthstatemnusmiic
bull MIIC regions and regional coordinators
Clinical Practice MDH Immunization Program wwwhealthstatemnusimmunize
Got Your Shots News wwwhealthstatemnusdivsidepcnewslettersgys
MDH Immunization Information for Health Care Providers wwwhealthstatemnusdivsidepcimmunizehcp
bull Got Your Shots A Providers Guide to Immunization in Minnesota bull Vaccine protocols bull Forms for tracking patient immunizations bull Immunization schedules for Health Care Providers Immunization Action Coalition (IAC) wwwimmunizeorg
bull Ask the Experts bull VISs (Vaccine Information Statements and translations) bull Administration screening questions bull Medical management of vaccine reactions bull Order form for Californiarsquos Immunization Technique DVD Best Practices with Infants Children and Adults
Page 52 IPI Advisor Manual| February 2017
IPI Advisor Resource List Chapter 5
CDC ldquoPink Bookrdquo wwwcdcgovvaccinespubspinkbookindexhtml
CDC Advisory Committee on Immunization Practices (ACIP) wwwcdcgovvaccinesacip
CDC Vaccines and Immunizations wwwcdcgovvaccines
VAERS reporting httpvaershhsgovindex
Storage and Handling Got Your Shots Providers Guide ndash Managing Vaccine wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml
MnVFC Guide to Temperature Monitoring Devices wwwhealthstatemnusvfc
MDH Clinicianrsquos Vaccine Mishap Checklist wwwhealthstatemnusdivsidepcimmunizeipivaxchklstpdf
MDH Vaccine Storage Guide wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml
CDC Vaccine Storage and Handling Toolkit wwwcdcgovvaccinesrecsstoragetoolkit
You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Vaccine manufacturer phone numbers wwwcdcgovvaccinespubspinkbookdownloadsappendicesFcontact-info-manufactpdf
IAC Checklist for Safe Vaccine Handling and Storage wwwimmunizeorgcatgdp3035pdf
IAC Donrsquot Be Guilty of These Errors in Vaccine Storage and Handling wwwimmunizeorgcatgdp3036pdf
Additional Resources Print materials from MDH ndash order forms wwwhealthstatemnusdivsidepcimmunizeordermathtml
Vaccine Education Center ndash Childrenrsquos Hospital of Philadelphia wwwchopeduservicevaccine-education-centerhomehtml
California Department of Public Health ndash Interactive training on vaccine administration and storage and handling handout on transporting vaccine and how to package wwwezizorg
IPI Advisor Manual | February 2017 Page 53
IPI Advisor Resource List Chapter 5
CDC vaccine price list wwwcdcgovvaccinesprogramsvfcawardeesvaccine-managementprice-listindexhtml
Vaccine Information Statements (VIS) wwwcdcgovvaccineshcpvisindexhtml
CEU Opportunities CDC Immunization Education and Training wwwcdcgovvaccinesedindexhtml
Immunization You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Page 54 IPI Advisor Manual| February 2017
- Introduction
-
- Welcome to the Immunization Practice Improvement (IPI) Program
- Contact Information
-
- Chapter 1
- Requirements to Participate in the MnVFC Program
- Vaccines for Children Program
- Chapter 2
- Reimbursement for MnVFC Visits
- Types of Visits
- Your MnVFC Clinical CoordinatorPlanner
- New IPI Advisor Training Requirements
- Your Role as an IPI Advisor
- Reasons MDH Would Do All or Part of a Visit
- Chapter 3
- Future follow-up
- Conducting the Visit
- Preparing for the Visit
- Information for the Visit
- Site Visit Checklist
- Scheduling the Visit
- Chapter 4
- After the Site Visit
- MnVFC Provider Follow-up Plan
- MnVFC Site Visit Storage and Handling Per Unit Answer Sheet
- Section 6 Inventory
- Section 5 Storage amp Handling Site-Wide
- Section 4 Storage amp Handling Per Unit
- Section 3 Documentation
- Section 2 Eligibility
- Section 1 Provider Details
- The Site Visit Reviewer Legend
- MnVFC Site Visit Questionnaire
- Required Paperwork for Site Visits
- Chapter 5
-
IPI Advisor Manual | February 2017 Page 31
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 41
4 Storage amp Handling Per Unit Storage Unit Build amp Use
Question 41 Below select the build and use of the vaccine storage unit you are assessing
Note to Reviewer Dorm-style units Do not add dorm-style units here Dorm-style units will be addressed in section 5 Units storing only private stock You must review these storage units even if they contain only private stockat the time of the visit because that vaccine could be administered to VFC patients
A What type of unit is this A Stand-alone B Combination
B Select use if stand-alone A Freezer B Refrigerator
Select use if combination A Use both sections to store vaccine B Use freezer section only to store vaccine C Use refrigerator section only to store vaccine
Goal of this question Identify the unit you are evaluating The description asks you to create a unique name for this unit so that you will be able to identify the same unit in future site visits Put this description on the top of the answer sheet (ie make and location)
Helpful information bull A stand-alone unit is either a refrigerator or a freezer It does not have both sections in the unit bull If there is a combination unit note if the site uses both the refrigerator and freezer or only one section of the unit to store vaccines CDC does not recommend the use of either section or the freezer section only of combination household units
bull If your site utilizes the separate stock method of vaccine management you must review storage units even if they contain only private stock at the time of the visit because there is a chance that those vaccines could be administered (borrowed) to VFC-eligible patients
Page 32 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 424 Storage amp Handling Per Unit CDC Recommended Storage Units
Question 42 Below document the grade of the vaccine storage unit you are assessing
Note to Reviewer Pharmaceutical Also called ldquopurpose-builtrdquo these units are designed by the manufacturer specifically tostore vaccines or other biological materials Commercial Although usually intended to store food and beverages commercial units are often larger and more powerful than the household units found in most homes Though these units are intended to meet thehigher demands of larger facilities these units are not specifically built for the storage of biologicalmaterials Household (non-commercialdomestic) These units are usually smaller than commercial units and areintended for use in small offices and in homes ndash typically for food storage However just like commercialunits they are not designed specifically for the storage of biological materials Such units are usually available in common home supply stores
Answers (Choose one)
Select grade A Pharmaceutical B CommercialHousehold
[O] CDC does not recommend the use of both sections or the freezer section only of combination commercialhousehold units
Review CDC Recommendation
CDC recommends the following vaccine storage unit types (in order of preference) pharmaceutical grade stand-alone orcombination units (preferred) householdcommercial stand-alone units householdcommercial combination units using therefrigerator section only
Goal of this question Assess the grade and type of each storage unit bull Pharmaceutical grade units may be stand-alone or combination units that are often metal may have glass in the door for viewing inside often have an external digital temperature display and are manufactured by medical companies
bull Commercial or household units often look like your kitchen appliance have vegetablemeat drawers in the unit and are manufactured by household appliance companies
bull Occasionally you might find a medical grade unit which is usually a commercialhousehold unit with a lock and 3-prong plug These are still considered household units because of their ability to maintain proper temperatures and air flow Studies show that household stand-alone units are better able to maintain consistent temperatures than their combination counterparts Combination household units used to store vaccine in both sections of the unit is no longer recommended and may be prohibited in the future Combination household storage units that are having difficulty maintaining a cold enough freezer temperature and a warm enough refrigerator temperature should be replaced or a separate stand-alone freezer should be purchased
For frozen vaccines the most cost effective solution is for the site to purchase a small stand-alone freezer The site may need time to budget for a stand-alone storage unit
Resources bull Replacing Combination Household Units Tip Sheet on IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml)
IPI Advisor Manual | February 2017 Page 33
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 434 Storage amp Handling Per Unit Temperature Monitoring Device in the Unit
Question 43 Determine whether there is a temperature monitoring device in this section of the storage unit andanswer the questions
A Is there a temperature monitoring device in this section of thestorage unit
Yes No [X] (If no skip to question 47)
B Who is responsible for supplying the temperature monitoring device in this section of the storage unit Provider
Review CDC Requirement
Certificates of calibration testing provide confidence that the temperature monitoring device is measuring temperaturesaccurately All units storing VFC vaccines must have a calibrated temperature monitoring device with a current and valid certificateof calibration testing All certificates must contain modeldevice name or number serial number date of calibration testing (report or issue date) and Instrument Passed testingInstrument in Tolerance (Recommended uncertainty = +-05ordm C (+-1ordm F))
Goal of this question Assess whether there is a temperature monitoring device in the unit If the unit is not being monitored at all call MDH at 651-201-5522 for guidance
Helpful information bull This question does not ask whether the temperature monitoring device is working or the characteristics of the device These issues will be addressed later in the questionnaire
bull For part B the provider is always responsible for supplying the temperature monitoring device Even if their thermometer or data logger was originally from MDH it is their responsibility to ensure it is functional and calibrated
Resources bull Section 8 in the MnVFC Policies and Procedures Manual
Page 34 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 444 Storage amp Handling Per Unit CDC Recommended Temperature Monitoring Device
Question 44 Assess the temperature monitoring device in this section of the storage unit to answer the questionsbelow
A Is the temperature monitoring device a continuous monitoring and recordingdevice (eg data logger)
Yes No [O] (Skip D)
B Does the temperature monitoring device have a probe in buffered material Yes No [O]
C Does the temperature monitoring device have a digital display that can beeasily read from the outside of this unit
Yes No [O]
D Is data downloaded and reviewed routinely Yes No [O]
Review CDC Recommendation
As of Jan 1 2018 all VFC providers must use continuous temperature monitoring devices (eg data loggers) to monitor vaccinesthat will be administered to VFC-eligible children Routine review and accessibility of temperature data is critical for determining whether vaccine has been properly stored and for assessing usability of vaccine that was involved in a temperature excursion Tomeet VFC Program requirements the device must also be equipped with bull A temperature probe bull An active temperature display that can be easily read from the outside of the unit bull The capacity for continuous monitoring and recording capabilities where the data can be routinely downloaded
The following are additional recommended features for these devices bull Alarm for out-of-range temperatures bull Current minimum and maximum temperatures display bull Low battery indicator bull Accuracy of +- 1degF (05degC) bull Memory storage of at least 4000 readings bull User programmable logging interval (or reading rate) recommended at a maximum time interval of every 30 minutes bull Use of a probe that best reflects the temperature of the vaccine (such as a buffered probe)
Goal of this question Assess the temperature monitoring device in the storage unit Note that these are all recommendations not requirements at this time
This is a great teaching opportunity for sites who do not currently have a continuous temperature monitoring device Beginning Jan 1 2018 all units that store MnVFC vaccine will be required to have a continuous temperature monitoring device (ie a data logger or a continuous temperature monitoring system) Unlike a minmax thermometer a continuous temperature monitoring device provides detailed information on all temperatures recorded at pre-set intervals For excursions it can provide information on when a temperature went out-of-range for how long and what the temperatures were This is essential information that vaccine manufacturers need to know to assess the viability of the vaccine following an excursion
Helpful information bull Sites are required to monitor and record temperatures twice daily however temperature excursions can easily occur in the 12 hours or longer between readings Continuous temperature monitoring can help manufacturers determine vaccine viability
bull Continue to encourage sites to document and evaluate minimum and maximum temperatures the storage unit reached since the last reading and respond appropriately to out-of-range temperatures
IPI Advisor Manual | February 2017 Page 35
The 2017 MnVFC Site Visit Paperwork Chapter 4
bull It is recommended that sites download and review data weekly Discuss with sites that reviewing temperature monitoring device data also includes responding appropriately if they identify out-of-range temps
bull There is sometimes confusion about the difference between a data logger and a continuous temperature monitoring system Here are some differences
Data Loggers Continuous Monitoring Systems Have an external display similar to thermometers May or may not have an external display Have a detachable probe Probe is usually attached to transmitter Need to be plugged into the computer or cradle to download information on a regular schedule
Wirelessly sends data to computer system
Create a file of data that needs to be saved on the computer
Data is stored within the system not a separate file
Doesnrsquot allow documentation of twice a day temperature checks in the file
May allow documentation of twice a day temperature checks within the system
More about the 2018 requirement for a continuous temperature monitoring device
Required Features bull The continuous temperature monitoring device must have Continuous monitoring and recording capabilities to track and record temperatures over time The capacity to routinely download temperature data to a computer (recommended at least weekly) or wirelessly transmit data Detachable probe in a bottle filled with a thermal buffer (eg bio-safe glycol) if the data logger needs to be detached in order to download data Active temperature display
Recommended Features bull MnVFC recommends continuous temperature monitoring devices with Alarm for out-of-range temperatures Accuracy within +-1degF (+- 05degC) Low battery indicator Display of current minimum and maximum temperatures Memory storage of at least 4000 readings User programmable logging intervals (eg the user can set how often the device records the temperature)
Note that these are all currently recommendations not requirements yet
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Page 36 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 45
Goal of this question Ensure the temperature monitoring device is properly calibrated The certificate of calibration testing means that the device has been tested and it is accurately measuring temperatures within established testing limits The certificate of calibration ensures that the device meets all the required components
Helpful information bull The provider is always responsible for having a current certificate of calibration (or copy) on-site
bull To be considered ldquovalidrdquo a certificate of calibration must contain these required elements Modeldevice name or number Serial number
4 Storage amp Handling Per Unit Certificate of Calibration Testing
Review CDC Requirement
Certificates of calibration testing provide confidence that the temperature monitoring device is measuring temperaturesaccurately All units storing VFC vaccines must have a calibrated temperature monitoring device with a current and valid certificateof calibration testing All certificates must contain modeldevice name or number serial number date of calibration testing (report or issue date) and Instrument Passed testingInstrument in Tolerance (Recommended uncertainty = +-05ordm C (+-1ordm F))
Question 45
Note to Reviewer
A
B
C
D
E
Review the certificate of calibration testing for the temperature monitoring device in this section of the storage unit and answer the questions below
bull How to determine certificate of calibration testing expiration date 1) Identify the certificate issuecalibration date 2) Apply the Immunization Program-required frequency for calibration testing Example If the
issuecalibration date is 12312013 and Immunization Program policy requires testing every twoyears the expiration date is 12312015
bull Certificates must include all of the below bull ModelDevice Name or Number bull Serial Number bull Date of Calibration Testing (Report or Issue Date) bull Instrument Passed testing (Instrument in Tolerance)
Is there a certificate of calibration testing for the temperature monitoring Yes device in this section of the storage unit No [X]
What is the date of calibration for the temperature monitoring device in this section of the storage unit
What is the certificatersquos date of expiration based on ImmunizationProgram policy (See note to reviewer to determine expiration date) [X] Follow-up is required if
certificate is expired
Does the certificate contain all the necessary items listed in the Note to Yes Reviewer No [X]
Who is responsible for supplying the current and valid certificate of Provider calibration for this temperature monitoring device
Date of calibration testing (report or issue date) Note If there is no expiration date the certificate expires 2 years from the date of calibration Whether the instrument passed or failed testing (or instrument in tolerancenot in tolerance)
bull Recommended element Documented uncertainty of +- 1degF [05degC]
If these elements are present the certificate is considered valid If the certificate contains information about the recommended element or the entity that issued the certificate that is helpful but not required
To determine if a certificate of calibration testing was issued by an appropriate entity check to see if the certificate indicates one or more of these items (this is the wording used to help sites evaluate if their calibration is accurate but is not required on the certificate itself to be considered valid)
bull Conforms to ISO 17025 bull Performed by an ILACMRA Signatory body accredited laboratory You can review this list of the ILAC MRA and Signatories (httpilacorgilac-mra-and-signatories)
bull Traceable to the standards maintained by NIST bull Meets specifications and testing requirements for the American Society for Testing and Materials (ASTM) Standard E2877 tolerance Class F (le 05 degC) or better
bull Includes reference to another acceptable accuracy validation method such as comparison to other traceable reference standards or tests at thermometric fixed points
Note CDC recommends that certifications be issued for the entire monitoring unit (detachable probe data logger etc) and not individual certificates for each component
IPI Advisor Manual | February 2017 Page 37
The 2017 MnVFC Site Visit Paperwork Chapter 4
For 45 E the provider is always responsible for supplying the current and valid certificate of calibration for a temperature monitoring device
bull Tip If the temperature monitoring device has a sticker on the back with the calibration date the site can usually call the company who calibrated the device and get a copy of the certificate if they donrsquot have one
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 46 4 Storage amp Handling Per Unit Probe Placement
Question 46 Is the probe properly placed in this section of the storage unit
Note to Reviewer ldquoProperlyrdquo means that the probe in a commercial or household unit is placed in a central area of the unitdirectly with the vaccines Probes should not be placed in the doors near or against the walls close to vents or on the floor of the unit The only allowable exemption related to this requirement is for providerswho have pharmaceutical storage units (built for vaccine storage) that have either (1) a built-intemperature monitoring device OR (2) a dedicated port for the probe that dictates the placement of theprobe
Answers (Choose one)
Yes No [X]
Review CDC Requirement
The probe must be placed in a central area of the section of the storage unit directly with the vaccines in order to properly measurevaccine temperature The probe should not be placed in the door near or against the walls close to vents or on the floor of theunit For pharmaceutical units with a built-in temperature monitoring device or a dedicated port for a probe that is not in thecenter of the section of the storage unit consult your Immunization Program for guidance on placement
Goal of this question Make sure the temperature monitoring device is in the best location to accurately measure the temperature of the vaccines stored in the unit
Helpful information bull The probe of the temperature monitoring device should be placed directly with the vaccines in the middle of the unit The ONLY allowable exception is for pharmaceutical storage units that have either a built-in thermometer or a dedicated port for the probe that indicates placement of the probe
bull Temperatures can vary within the unit especially household units bull Call MDH at 651-201-5522 if you have questions
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Guide (wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml)
Page 38 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 474 Storage amp Handling Per Unit Temperature Documentation
Question 47 Review the temperature documentation over the past three months for this section of the storage unit todetermine whether the provider has a process in place for properly documenting temperatures twice aday Answer the questions below
A Are there two temperature readings recorded for this section of the storage unit per day
Yes No [X]
B Is there a time date and name (or initials) recorded for each reading Yes No [X]
C What is the current temperature and minmax temperatures (if available) inthis section of the storage unit Use the reviewerrsquos thermometer if the providerrsquos temperature monitoringdevice does not have a current valid certificate of calibration testing or the probe is not properly placed in this section of the storage unit
Current Temperature Minimum Temperature Maximum Temperature Fahrenheit Celsius
D Based on your review of the providerrsquos recent temperature documentationincluding the current temperature is this section of the storage unitmaintaining appropriate temperatures
Yes No [X] Not enough information [X]
Review CDC Requirement
Vaccines must be stored under appropriate temperatures as described in the package inserts at all times Acceptable temperature ranges vary by vaccine type and the range is 36deg F and 46deg F (2deg C and 8deg C) and for frozen vaccines the range is -58deg F and +5deg F (shy50deg C and -15deg C) Exposure to temperatures outside of those included in the package inserts could affect vaccine viability andultimately could leave children unprotected against vaccine-preventable diseases In order to maintain awareness of storage unittemperatures and ensure that vaccines are being stored at appropriate temperatures at all times VFC providers are required to monitor and document temperatures for all vaccine storage units at least twice a day Temperature documentation must contain (1) at least two temperature readings per day (2) the time and date of each reading and (3) the name (or initials) of the personwho assessed and recorded the readings CDC also recommends that VFC providers record the minimum and maximumtemperatures of each unit once each workday (preferably in the morning)
Goal of this question Ensure the temperature is being monitored twice daily is within the required range and documented correctly Use your thermometer to check the temperature if the sitersquos temperature monitoring devicersquos probe is not properly placed or there is not a current certificate of calibration Place your thermometer in the unit at the beginning of the visit to allow sufficient time to reach an accurate temperature The purpose of using your thermometer is to ensure the vaccine is being stored at the proper temperature not to ldquovalidaterdquo their reading
Question 47 D is an assessment question based on information you have learned during your visit You might answer ldquonot enough informationrdquo if the unit is new and they donrsquot have at least three months of data or if the unit is only used as overflow and they are inconsistent with temperature monitoring Mark ldquoNordquo if you have reason to believe the storage unit is not maintaining temperatures properly
Helpful information bull All sites must document temperatures twice a day every day the site is open even if they have a data logger or continuous monitoring system
bull Sites can document the information electronically with some continuous monitoring systems as long as it can show what the current temp is the date time and initials of the person checking ndash this needs to be someone at the site ndash not checking remotely or centrally for a large site or system The site must be able to produce these records during their site visit Reviewing these files can be a challenge due to large volumes and lots of paper
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Temperature Logs on Managing Vaccine (wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml)
IPI Advisor Manual | February 2017 Page 39
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 484 Storage amp Handling Per Unit Temperature Excursions
Question 48 In the event that a temperature excursion(s) occurred in this unit within the last three months requestand review documentation of actions taken to determine whether the provider has a process for properlyaddressing excursions Answer the questions below
A Were vaccines in this unit exposed to out-of-range temperatures in the lastthree months (including today)
Yes No (If no skip to question 49)
B Did the provider quarantine and label vaccines as ldquoDo not userdquo Yes No [X]
C Did the provider place vaccine in a unit where it can be stored under properconditions if applicable
Yes No [X]
D Did the provider contact the Immunization Program to report theexcursion
Yes No [X]
E Was the manufacturer contacted for documentation supporting theusability of the vaccine
Yes No [X]
Review CDC Requirement
The provider must document all excursions and actions taken including the following (1) Quarantine and label vaccines as ldquoDO NOTUSErdquo (2) Place vaccines in a unit where they can be stored under proper conditions (3) Contact the Immunization Program to report an excursion and (4) Contact the vaccine manufacturer to obtain documentation supporting the usability of the vaccine
Goal of this question Address any out-of-range temperatures (temperature excursions) identified in reviewing the last three months of temperature logs or during the site visit If there were any out-of-range temperatures did the site respond appropriately to the situation This is a great opportunity to discuss what to do in the event of an excursion The Clinicians Storage and Handling Mishap Checklist is in the IPI Site Visit information folder and is a good review of the process
Helpful information bull Sites need to know that an excursion does not automatically mean that exposed vaccines are non-viable or unusable Exposed vaccines must be quarantined (marked ldquoDo Not Userdquo) and stored under proper conditions until they have received information from vaccine manufacturers regarding the viability of the vaccine
bull Sites must inform MDH when an excursion occurs
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Clinicians Storage and Handling Mishap Checklist (wwwhealthstatemnusdivsidepcimmunize ipivaxchklstpdf)
Page 40 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 49
Goal of this question Ensure proper placement of vaccines in the storage unit
Note These are all recommendations (best practices) not requirements
Helpful information bull Store vaccine in the middle of the compartment two to three inches away from the coils walls floor and cold air vent The temperature near the floor and walls of the unit differs from that in the middle of the compartment and the cold air vent can freeze refrigerated vaccines
4 Storage amp Handling Per Unit Vaccine Placement
Question 49 Look inside the unit to answer the questions below
A Are vaccines placed in the middle of the unit with space between vaccinesand the sideback of the unit to allow cold air to circulate
Yes No [O]
B Are vaccines stored in their original packages Yes No [O]
C Are there water bottles (for refrigerators) or frozen water bottles (forfreezers) in the unit
Yes No [O]
D Are vaccines store in the doors vegetable bins under or near cooling ventsor on the floor of the unit
Yes [O] No
E Is food being stored in the unit Yes [O] No
Review CDC Recommendation
Vaccines should be stored in their original manufacturer (or CDC centralized distributor) packaging They should be placed in the middle of the unit with space between the vaccines and the sideback of the unit to allow cold air to circulate Vaccines SHOULD NOT be stored in the doors vegetable bins or floor of the unit or under or near cooling vents and there should not be any food inthe unit Water bottles (for refrigerators) or frozen water bottles (for freezers) should be placed throughout each storage unit inorder to (1) stabilize or extend temperatures during a power outage and (2) to serve as physical blocks preventing the placementof vaccines in areas of the unit that are at higher risk for temperature excursions (such as in doors vegetable bins floor ornearunder cooling vents)
bull Vaccines should be kept in their original packaging to Protect them from light Help prevent medication errors by making labels easier to read Provide a moisture barrier that serves as insulation in case of an out-of-range temperature power outage door left open or mechanical failure Simplify managing vaccine inventory
bull Store water bottles in the doors on the floor and near the cold air vent in the refrigerator and frozen water bottles in the freezer to help maintain a stable temperature if there is a power failure and when the door is opened frequently Too many water bottles in the door can prevent the door from closing tightly Mark water bottles ldquoDo Not Drinkrdquo
bull Do not store vaccine in the door or drawers of the refrigerator or freezer Vegetable bins and crisper drawers should be removed from refrigerators or used to store other medical supplies or water bottles
bull If vaccine is stored in a household combination refrigeratorfreezer The top shelf should not be used for storing vaccine because the cold air vent blowing from the freezer will freeze vaccine located there If you must use the top shelf of this type of unit place water bottles underneath the cold air vent to prevent vaccine from being stored there It is recommended that only the refrigerator be used for vaccine storage and a separate stand-alone freezer be used to store frozen vaccine
bull Must not store food or beverages in the refrigerator or freezer because frequent opening of doors can lead to temperature variations that may affect vaccine viability There is also a risk of contaminating vaccines
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Guide (wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml) bull Vaccine Storage Tip Sheet on IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml)
IPI Advisor Manual | February 2017 Page 41
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 4104 Storage amp Handling Per Unit Disconnection from Power Source
Question 410 Ask the provider to demonstrate what measures are taken to ensure that vaccine storage units are notaccidentally physically disconnected from the power supply Which of the following describes the measure(s) taken on this unit
Note to Reviewer bull Large hospitals and healthcare systems may not have the ability to demonstrate labels on plugs or circuitbreakers In such cases verify that the practice has a comprehensive policy and standard operatingprocedures in place to prevent the vaccine storage unit from being physically disconnected from thepower supply
bull While back-up generators may ensure power to the overall facility this question ONLY addresses thevaccine storage unit being accidentally disconnected from the power source either through the plug orthe circuit breaker
Answers A ldquoDo not disconnectrdquo labels on the plug (Choose all that B ldquoWarningrdquo label on the circuit breaker box
apply) C Hard-wired (ie built-in) and has a ldquoDo not disconnectrdquo label on thecircuit breaker box D Hospital or large health care system with a comprehensive written policyand standard operating procedures detailing measures taken to preventvaccine storage units from being accidentally disconnected from the powersupply E No acceptable measures for preventing accidental disconnection frompower supply [X]
[X] The response is non-compliant if only A only B or E is selected
Review CDC Requirement
VFC providers must take steps to protect the power source for all vaccine storage equipment by means of having clear warninglabels on both the plug and the circuit breaker associated with all vaccine storage units Large hospitals and healthcare systems canmeet this requirement by demonstrating that they have comprehensive policies and standard operating procedures to preventvaccine storage units from being physically disconnected from the power supply
Goal of this question Decrease the chance that a vaccine storage unit will be accidently unplugged or power will be turned off while vaccine is in the unit This question addresses only what measures the site has taken to ensure the storage unit is not physically disconnected from its power source
If the site uses labels on the plugs and circuit breakers perform a visual inspection to assess whether the way the stickers are positioned make it clear and obvious to anyone that these units are not to be disconnected
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Do Not Unplug and Warning stickers are included in the folder or available to order on the For
Professionals Order Form (wwwhealthstatemnusdivsidepcimmunizeordermathtml)
Note Once you have completed the 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet for each unit return to the questionnaire to complete sections 5 and 6
Page 42 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
- -
Section 5 Storage amp Handling Site-Wide Question 51
5 Storage amp Handling Site Wide Discussion of Cost amp Quantity of Vaccine
Question 51 Have a discussion with the provider about the cost and quantity of VFC vaccines they are responsible for annually Address the points listed in the note to reviewer below
Note to Reviewer bull Vaccine Shipped (Required) Share the cost of VFC vaccines shipped to the provider in the last calendaryear to make sure the provider understands the contribution made by the VFC Program to their practiceFor new providers who do not have ldquocalendar yearrdquo data share either the actual cost of their currentinventory or use the cost of 10 VFC doses of each of the ACIP-recommended vaccines (approximately $7000) to help estimate their annual cost
bull Storage amp Handling (Required) Make sure the provider understands the cost of vaccines for which they are responsible when they make decisions about purchasing recommended vaccine storage and temperature monitoring equipment
Answer I have discussed with the provider the cost and quantity of vaccines ordered in the previous calendar year
Goal of this question Inform sites of the quantity and value of vaccines that they receive as part of the MnVFC program Providers often donrsquot realize the value of the vaccine in their unit This information is included on your clinic list and on the one page site-specific information
Helpful information bull This discussion must occur and the box on the questionnaire must be checked bull If there isnrsquot actual vaccine value information available tell the site that one vaccine order that includes a box of each of the ACIP recommended vaccines costs approximately $7000
bull MDH may not have specific information for individual sites if they receive vaccine from a central warehouse or pharmacy For those sites MDH will give you numbers for the whole system so you can discuss system wide data as appropriate If individual site information is also included it is usually just varicella-containing vaccines that must be shipped directly to the site
Question 52
5 Storage amp Handling Site Wide Dorm Style Units
Question 52 Determine whether the provider has any dorm-style units on site and answer the questions below
Note to Reviewer A dormitory-style refrigerator is a unit that has both refrigerator and freezer compartments behind a singleexterior door Dorm-style units also have an evaporator plate (cooling coil) which is usually located insidean icemaker compartment (freezer) within the refrigerator
A Does the provider have any dorm-style units that are used at any time tostore vaccines
Yes [X] No (Skip to question 53)
B Does the provider have sufficient space in existing compliant vaccinestorage units to store all vaccines without use of the dorm-style unit at any time
Yes No [X]
Review CDC Requirement
Dorm- and bar-style units are prohibited for vaccine storage Vaccines stored in dorm-style units are considered non-viable and must be returned to the centralized distributor CDC recommends the following vaccine storage unit types (in order of preference)pharmaceutical grade stand-alone or combination units (preferred) householdcommercial stand-alone unitshouseholdcommercial combination units using the refrigerator section only
Goal of this question Ensure no vaccine is stored in dorm-style units even for short periods of time Encourage them to label any units ldquoNo Vaccine Storage Allowedrdquo Vaccine stored in these units is considered non-viable If a site is using a dorm-style unit call the MnVFC program (651-201-5522)
Resource Section 8 in the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 43
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 535 Storage amp Handling Site Wide Storage Unit Space Availability
Question 53 Does the provider have sufficient room across storage units to store current stock as well as anyadditional stock acquired during peak season without overcrowding
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have sufficient storage space to accommodate vaccine stock at the busiest time of year without overcrowding
Goal of this question Ensure that sites have sufficient space in their units to maintain vaccines at the busiest time of year Overcrowding of vaccine limits air circulation and affects the unitrsquos ability to maintain stable temperatures
Helpful information bull Look for signs of overcrowding such as vaccines that are pushed up against the wall bins that are overflowing or storage units that are full during non-peak seasons
Discuss immediate actions if the unit is overcrowded Move some of their vaccines order less vaccine more frequently (once per month preferably) andor purchase another storage unit for overflow
Resource bull Section 8 MnVFC Policy and Procedure Manual
Page 44 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 545 Storage amp Handling Site Wide Expired Vaccines
Question 54 Look in each unit Are there expired vaccines in any of the vaccine storage units at this site
Answers (Choose one)
Yes [X] No
Review CDC Requirement
Vaccines should be rotated weekly and when a new shipment comes in so that longer-dated vaccines are stored behind shorter-dated vaccines If vaccines expire they can no longer be stored in the same storage unit with viable vaccines They must be placedin a container or bag clearly labeled ldquoDo not userdquo and separated from viable vaccines to prevent inadvertent use Expired vaccinemust be returned to the centralized distributor within six months of expiration
Goal of this question Ensure there is no expired vaccine in any storage unit
Helpful information bull Sites can prevent their stock from expiring by rotating vaccines every week andor when a new shipment arrives Longer-dated vaccines are stored towards the back of the unit and shorter-dated vaccines are up front
bull Pay attention to vaccines that expire within the next three months Consider transferring vaccine that will expire soon to another MnVFC-enrolled site that will use the vaccine preferably a site close by It is the transferring sitersquos responsibility to arrange the transfer of the vaccine Be sure to complete the MDH Vaccine Transfer Record form and send it to MDH If they are having difficulty finding a location to accept vaccine contact MDH
bull This is a great opportunity to educate sites about the MDH Nonviable Vaccine Form and the process for returning vaccine The VFC program does get some credit for taxes and fees on vaccine that is returned to the distribution center
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MDH Nonviable Vaccine Form and MDH Vaccine Transfer Record on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfcformshtml)
IPI Advisor Manual | February 2017 Page 45
The 2017 MnVFC Site Visit Paperwork Chapter 4
- -
-
Question 555 Storage amp Handling Site Wide Back up Thermometer
Question 55 Does the provider have a readily available back-up thermometer with a current and valid certificate ofcalibration testing
Note to Reviewer ldquoReadily availablerdquo means that the thermometer is available to perform twice-a-day monitoring for a unit asrequired CDC recommends that the back-up thermometer be maintained on site
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have a readily available back-up thermometer with a current and valid certificate of calibration testing Toprevent the certificates of calibration testing of the primary and back-up thermometers from expiring at the same time the date of calibration testing (or issue date) of the back-up thermometer should be different from the date of calibration testing (or issue date) of the primary thermometer As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meetsVFC program requirements
Goal of this question Ensure sites have one calibrated back-up thermometer onsite that is readily available in the event that the temperature monitoring device in unit fails transportation of vaccine is needed or there are other unexpected circumstances
Helpful information bull As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meets VFC Program requirements
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 56 5 Storage amp Handling Site Wide Preparation of Vaccine
Question 56 When does this provider prepare vaccine for administration to the patient
Note to Reviewer For mass vaccination clinics if one type of vaccine is offered providers may pre-draw up to 10 doses Ifusing pre-filled syringes pre-drawing also means activating the syringe by removing the needle guard orattaching a needle
Answers (Choose all that
apply)
Prepare dose immediately before administration Pre-draw doses for upcoming patients (in a regular clinicpractice) [O] Pre-draw up to 10 doses (in a mass-vaccination clinic) Pre-draw more than 10 doses (in a mass-vaccination clinic) [O] Other [O]
Review CDC Recommendation
CDC recommends preparing vaccines immediately prior to administration in order to assure viability of vaccine and prevent vaccinewastage Vaccines that are not administered immediately are at risk of exposure to temperatures outside of the required rangewhich can affect vaccine viability and ultimately can leave children unprotected against vaccine-preventable diseases
Goal of this question Discuss proper timing and preparation of vaccine(s) for administration These are recommendations not requirements
Helpful information bull Educate staff on the importance of preparing vaccine immediately before administration Pre-drawing of vaccines may lead to concerns related to vaccine viability potency sterility and wastage
Page 46 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 6 Inventory Question 61
6 Inventory Inventory Comparison
Question 61 Visually inspect storage units to determine if existing supply of vaccines proportionately mirrorspopulations served Choose the most accurate statement below
Note to Reviewer bull CDC recommends that providers maintain a four-week supply of inventory bull For this question do not take into account vaccine types that the provider does not order Here simply
make sure that overall the vaccines in the providerrsquos storage units are available in sufficient amounts toserve their patient population
Answers (Choose one)
The current vaccine inventory proportionately reflects the populations identified Only public stock is insufficient [X] Only private stock is insufficient [X] Both public and private stock are insufficient [X] Site uses the replacement method but does not appear to have enough vaccine for their population [X] Other [X]
Review CDC Requirement
VFC providers must order and stock routine vaccines in accordance with their patient population in order to prevent missedvaccination opportunities Having sufficient amounts of all stocks prevents the inadvertent use of VFC vaccines for non-VFC-eligiblepatients and vice versa
Goal of this question Assess whether the site is ordering appropriate quantities of vaccine for the population they serve at their site
Helpful information bull If the site sees 30 percent private-pay patients and 70 percent VFC the stock in their storage units should reflect that proportion If you donrsquot know you can ask the site about their population
bull This is meant to be a general assessment so in a big site if they have only a small amount of vaccine that may indicate an issue with vaccine management
bull CDC recommends smaller more frequent orders (ie monthly) rather than large orders to minimize the amount of vaccine loss if an incident occurs during shipment or in the storage unit Sites should not order more frequently than once a month
bull Sites using the replacement method will only have one stock but it should appear to be large enough for their population
bull Only assess the vaccine types that the site currently stocks in their unit We know there are sites that do not offer all ACIP-recommended vaccines for various reasons That issue will be addressed in question 62
IPI Advisor Manual | February 2017 Page 47
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 626 Inventory ACIP Recommended Vaccines
Question 62 Review providerrsquos current inventory to answer the questions below
A Does the provider offer all routine ACIP-recommendedvaccines for their patient population
Yes (Skip to question C) No [X] Offers all except varicella because direct ship ofvaccine is unavailable from manufacturer
B Which routine vaccines are NOT being offered DTaP Hepatitis A Hepatitis B HIB HPV Influenza Meningococcal
MMR Pneumococcal Polio Rotavirus TdapTd Varicella
C According to Immunization Program Policy does theprovider make accessible all non-routine ACIP-recommended vaccines for those VFC patients whomeet the criteria for receiving them
Yes (Skip to question 63) No [X]
D Which non-routine vaccines are NOT being offered Pneumococcal polysaccharide vaccine (PPSV23) Meningococcal Group B (MenB) Other
Review CDC Requirement
VFC providers agree to comply with immunization schedules dosages and contraindications that are established by the Advisory Committee on Immunization Practices (ACIP) for the vaccines identified and agreed upon in the Provider Agreement UNLESS bull In the VFC providers medical judgment and in accordance with accepted medical practice the VFC provider deems such
compliance to be medically inappropriate for the child bull The particular requirements contradict state law including laws pertaining to religious and other exemptions The VFC program entitles children to the following vaccines DTaP Hepatitis A Hepatitis B HIB HPV Influenza MeningococcalMMR Pneumococcal Polio Rotavirus TdapTd and Varicella VFC providers are also required to ensure that VFC-eligible children have access to non-routine vaccines as needed
Goal of this question Assess if the site is offering all the ACIP-recommended vaccines for the population they serve and these vaccines are in stock on the day of the visit It is important that every MnVFC-eligible child that comes to a providerrsquos office for an immunization is vaccinated
Helpful information bull The Advisory Committee on Immunization Practices (ACIP) is a group of medical and public health experts that develops recommendations on how to use vaccines to control diseases in the United States
bull Specialty providers are not required to offer all routine vaccines but should provide the vaccines appropriate for their population
bull If the site does not offer all routine ACIP-recommended vaccines appropriate for their population check the ldquoNordquo box in Part A then check the appropriate box(es) in Part B for any vaccines not offered Please contact MDH as this situation offers us the opportunity to provide education to the site
bull For non-routine vaccines they must either be in stock or the site must have an alternative protocol in the routine management plan that ensures these children have access when applicable
Resources bull IAC Diseases and Vaccines (wwwimmunizeorgvaccines) bull CDC Advisory Committee on Immunization Practices (ACIP) (wwwcdcgovvaccinesacipindexhtml)
Page 48 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 636 Inventory Separation of Stock
Question 63 Observe how the provider differentiates stock in each storage unit to answer the questions below
A Is it clear which vaccines belong to public stock andwhich belong to private stock
Yes No [X] Not applicable replacement site
B Is it clear which vaccines belong to VFC stock andwhich belong to UUAV stock
Yes No [X] Not applicable replacement site Not applicable not UUAV-enrolled site
Review CDC Requirement
In order to ensure that VFC vaccines are only administered to VFC-eligible children VFC providers that serve both VFC and non-VFCshyeligible children must maintain their vaccine inventories in such a way that they can clearly differentiate public stock from privatestock as well as VFC from other public stock
Goal of this question Assess whether the site can distinguish between MnVFC vaccine and private vaccine If they participate in the Uninsured and Underinsured Adult Vaccine (UUAV) program they should also be able to distinguish between MnVFC stock and UUAV stock Some sites use labels bins boxes etc to differentiate their stock If it is not clear how the site differentiates their stock discuss vaccine management with the staff For follow-up call MDH to discuss doing a follow-up site visit
Sites using the replacement method will not have separate stocksmdashthis is an approved alternative method for keeping track of vaccine
Resource bull Section 10 of the MnVFC Policy and Procedure Manual
IPI Advisor Manual | February 2017 Page 49
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
MnVFC Site Visit Storage and Handling Per Unit Answer Sheet 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet MnVFC PIN ___________________
Question number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
Temperature Monitoring Device Questions Questions 43 47 must be answered separately for the freezer and refrigerator if the unit is a combo Be sure to document responses in the appropriate column
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
All the questions on the Site Visit Storage amp Handling Per Unit Answer Sheet have been discussed previously in section 4 of this manual Use this sheet to record information about all the units at the site visit You will need one sheet for each unit If it is a combination unit (either pharmaceutical or household) you can record both sections on one sheet If they have stand-alone units use one sheet for each unit Do not enter the answers to the questions in section 4 of the questionnaire
If you need more information about any of the questions refer back to the main questionnairemdashthe complete question additional guidance including notes to the reviewer and the CDC requirements are there Also if the site is not meeting the requirement you will go back to the questionnaire to complete the ldquoActions if Non-compliantrdquo section including the root cause analysis and follow-up sections
When you have completed the assessment of all the storage units remember to go back to the questionnaire to complete sections 5 and 6
Page 50 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
ndash
ndash
MnVFC Provider Follow-up PlanThe goal of the Provider Follow-up Plan is to communicate with the site all of the VFC requirements any unmet requirements found during your site visit and the timeline for completing the required action The left hand column is a box to check for ldquoUnmetrdquo requirements
Helpful information bull The form can be used to review what the site is doing well and what they need to work on
bull For requirements that have specific documentation that needs to be sent to you use the notes section
2017 MnVFC Provider Follow-up Plan Site _______________________________________________ MnVFC PIN ____________ Date of Visit ___________
Thank you for participating in this MnVFC compliance site visit Please review this visit summary including follow-up actions and timelines for completion Unmet MnVFC requirements and recommendations have a checked box next to them The goal of this plan is to support you with successfully implementing the program and improving access to vaccines for VFC-eligible children
Unmet Question VFC Requirements Section 1 Changes to Key Staff
Q12 Change in the Medical Director Immunization Manager Vaccine Coordinator or back-upKey Staff must be communicated to the immunization program by emailing healthmnvfcstatemnus Changes Notes
Q12 Key staff must complete the annual training on VFC program requirements and print theAnnual Training certificate of completion Documentation Required Action
Staff that have not completed the MnVFC online training must complete it and send acopy of the certificate to the reviewer Training can be found on the MnVFC website (wwwhealthstatemnusvfc) Due date 1 month
Notes
Unmet Question VFC Requirements Section 2 Eligibility
Q21 Provider staff must possess a working knowledge of all VFC eligibility criteria and use thoseVFC Eligibility criteria to screen children prior to administering VFC vaccines
Categories Notes
bull This form provides documentation needed for follow-up actions when you send your thank you email
The second to last page of the Provider Follow-up Plan has a summary of the MnVFC program recommendations These are to remind the site about best practices they may want to improve upon even though they are not yet requirements of the program For example you could discuss the recommendation about storage units if they currently have a combination household unit and are using both sections
The last section is for your signature and the person you met with In most sites it will be the immunization manager or vaccine coordinator who signs the form unless the medical director attended the site visit You keep the original copy and the site will need to keep a copy for themselves
To be completed by the site visit reviewer
I acknowledge that a VFC site visit was performed on __________________ (visit date) The follow-up plan which includes a list of all current VFC program requirements and recommendations assessed during the visit and any required follow-up actions was provided at the end of the visit
Site visit reviewer
Phone
Reviewer Signature Date
To be completed by the provider
I acknowledge that our practice took part in the VFC site visit noted above I understand the findings of the visit and any required actions that must be taken by our office in order to meet VFC program requirements
Medical Director (or designee) Name Title
Medical Director (or designee) Signature Date
IPI Advisor Manual | February 2017 Page 51
The 2017 MnVFC Site Visit Paperwork Chapter 4
After the Site Visit Send a thank you email highlighting the unmet requirements documents you need from the site to resolve the issue(s) and the date you need them Make sure to include the link to the Site Visit Survey (httpssurveyvovicicomseashxs=56206EE334CE0B14)
Please refer to Chapter 3 for more information about future follow-up required after the visit including forms and documentation
Resource bull Sample Thank You letter on IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml)
Chapter 5
IPI Advisor Resource List MnVFC Program 651-201-5522
MnVFC wwwhealthstatemnusvfc
bull Separate Stock and Replacement Method Policies and Procedures Manuals bull Online trainings bull MnVFC Announcements sign up to receive them via email bull Ordering MDH vaccine bull MnVFC forms Screening forms Reporting forms Others MDH Nonviable Vaccine Form MDH Vaccine Transfer Record and Vaccine Borrowing Report
bull MnVFC promotional materials bull Immunization Billing Guidance for MnVFC and Immunization Billing Guidance for MnVFC Replacement Sites Immunization Practices Improvement Program (IPI) wwwhealthstatemnusdivsidepcimmunizeipi
bull IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml) bull IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml) IPI Resource Folder Contents (wwwhealthstatemnusdivsidepcimmunizeipiipifolderpdf)
Minnesota Immunization Information Connection (MIIC) wwwhealthstatemnusmiic
bull MIIC regions and regional coordinators
Clinical Practice MDH Immunization Program wwwhealthstatemnusimmunize
Got Your Shots News wwwhealthstatemnusdivsidepcnewslettersgys
MDH Immunization Information for Health Care Providers wwwhealthstatemnusdivsidepcimmunizehcp
bull Got Your Shots A Providers Guide to Immunization in Minnesota bull Vaccine protocols bull Forms for tracking patient immunizations bull Immunization schedules for Health Care Providers Immunization Action Coalition (IAC) wwwimmunizeorg
bull Ask the Experts bull VISs (Vaccine Information Statements and translations) bull Administration screening questions bull Medical management of vaccine reactions bull Order form for Californiarsquos Immunization Technique DVD Best Practices with Infants Children and Adults
Page 52 IPI Advisor Manual| February 2017
IPI Advisor Resource List Chapter 5
CDC ldquoPink Bookrdquo wwwcdcgovvaccinespubspinkbookindexhtml
CDC Advisory Committee on Immunization Practices (ACIP) wwwcdcgovvaccinesacip
CDC Vaccines and Immunizations wwwcdcgovvaccines
VAERS reporting httpvaershhsgovindex
Storage and Handling Got Your Shots Providers Guide ndash Managing Vaccine wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml
MnVFC Guide to Temperature Monitoring Devices wwwhealthstatemnusvfc
MDH Clinicianrsquos Vaccine Mishap Checklist wwwhealthstatemnusdivsidepcimmunizeipivaxchklstpdf
MDH Vaccine Storage Guide wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml
CDC Vaccine Storage and Handling Toolkit wwwcdcgovvaccinesrecsstoragetoolkit
You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Vaccine manufacturer phone numbers wwwcdcgovvaccinespubspinkbookdownloadsappendicesFcontact-info-manufactpdf
IAC Checklist for Safe Vaccine Handling and Storage wwwimmunizeorgcatgdp3035pdf
IAC Donrsquot Be Guilty of These Errors in Vaccine Storage and Handling wwwimmunizeorgcatgdp3036pdf
Additional Resources Print materials from MDH ndash order forms wwwhealthstatemnusdivsidepcimmunizeordermathtml
Vaccine Education Center ndash Childrenrsquos Hospital of Philadelphia wwwchopeduservicevaccine-education-centerhomehtml
California Department of Public Health ndash Interactive training on vaccine administration and storage and handling handout on transporting vaccine and how to package wwwezizorg
IPI Advisor Manual | February 2017 Page 53
IPI Advisor Resource List Chapter 5
CDC vaccine price list wwwcdcgovvaccinesprogramsvfcawardeesvaccine-managementprice-listindexhtml
Vaccine Information Statements (VIS) wwwcdcgovvaccineshcpvisindexhtml
CEU Opportunities CDC Immunization Education and Training wwwcdcgovvaccinesedindexhtml
Immunization You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Page 54 IPI Advisor Manual| February 2017
- Introduction
-
- Welcome to the Immunization Practice Improvement (IPI) Program
- Contact Information
-
- Chapter 1
- Requirements to Participate in the MnVFC Program
- Vaccines for Children Program
- Chapter 2
- Reimbursement for MnVFC Visits
- Types of Visits
- Your MnVFC Clinical CoordinatorPlanner
- New IPI Advisor Training Requirements
- Your Role as an IPI Advisor
- Reasons MDH Would Do All or Part of a Visit
- Chapter 3
- Future follow-up
- Conducting the Visit
- Preparing for the Visit
- Information for the Visit
- Site Visit Checklist
- Scheduling the Visit
- Chapter 4
- After the Site Visit
- MnVFC Provider Follow-up Plan
- MnVFC Site Visit Storage and Handling Per Unit Answer Sheet
- Section 6 Inventory
- Section 5 Storage amp Handling Site-Wide
- Section 4 Storage amp Handling Per Unit
- Section 3 Documentation
- Section 2 Eligibility
- Section 1 Provider Details
- The Site Visit Reviewer Legend
- MnVFC Site Visit Questionnaire
- Required Paperwork for Site Visits
- Chapter 5
-
Page 32 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 424 Storage amp Handling Per Unit CDC Recommended Storage Units
Question 42 Below document the grade of the vaccine storage unit you are assessing
Note to Reviewer Pharmaceutical Also called ldquopurpose-builtrdquo these units are designed by the manufacturer specifically tostore vaccines or other biological materials Commercial Although usually intended to store food and beverages commercial units are often larger and more powerful than the household units found in most homes Though these units are intended to meet thehigher demands of larger facilities these units are not specifically built for the storage of biologicalmaterials Household (non-commercialdomestic) These units are usually smaller than commercial units and areintended for use in small offices and in homes ndash typically for food storage However just like commercialunits they are not designed specifically for the storage of biological materials Such units are usually available in common home supply stores
Answers (Choose one)
Select grade A Pharmaceutical B CommercialHousehold
[O] CDC does not recommend the use of both sections or the freezer section only of combination commercialhousehold units
Review CDC Recommendation
CDC recommends the following vaccine storage unit types (in order of preference) pharmaceutical grade stand-alone orcombination units (preferred) householdcommercial stand-alone units householdcommercial combination units using therefrigerator section only
Goal of this question Assess the grade and type of each storage unit bull Pharmaceutical grade units may be stand-alone or combination units that are often metal may have glass in the door for viewing inside often have an external digital temperature display and are manufactured by medical companies
bull Commercial or household units often look like your kitchen appliance have vegetablemeat drawers in the unit and are manufactured by household appliance companies
bull Occasionally you might find a medical grade unit which is usually a commercialhousehold unit with a lock and 3-prong plug These are still considered household units because of their ability to maintain proper temperatures and air flow Studies show that household stand-alone units are better able to maintain consistent temperatures than their combination counterparts Combination household units used to store vaccine in both sections of the unit is no longer recommended and may be prohibited in the future Combination household storage units that are having difficulty maintaining a cold enough freezer temperature and a warm enough refrigerator temperature should be replaced or a separate stand-alone freezer should be purchased
For frozen vaccines the most cost effective solution is for the site to purchase a small stand-alone freezer The site may need time to budget for a stand-alone storage unit
Resources bull Replacing Combination Household Units Tip Sheet on IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml)
IPI Advisor Manual | February 2017 Page 33
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 434 Storage amp Handling Per Unit Temperature Monitoring Device in the Unit
Question 43 Determine whether there is a temperature monitoring device in this section of the storage unit andanswer the questions
A Is there a temperature monitoring device in this section of thestorage unit
Yes No [X] (If no skip to question 47)
B Who is responsible for supplying the temperature monitoring device in this section of the storage unit Provider
Review CDC Requirement
Certificates of calibration testing provide confidence that the temperature monitoring device is measuring temperaturesaccurately All units storing VFC vaccines must have a calibrated temperature monitoring device with a current and valid certificateof calibration testing All certificates must contain modeldevice name or number serial number date of calibration testing (report or issue date) and Instrument Passed testingInstrument in Tolerance (Recommended uncertainty = +-05ordm C (+-1ordm F))
Goal of this question Assess whether there is a temperature monitoring device in the unit If the unit is not being monitored at all call MDH at 651-201-5522 for guidance
Helpful information bull This question does not ask whether the temperature monitoring device is working or the characteristics of the device These issues will be addressed later in the questionnaire
bull For part B the provider is always responsible for supplying the temperature monitoring device Even if their thermometer or data logger was originally from MDH it is their responsibility to ensure it is functional and calibrated
Resources bull Section 8 in the MnVFC Policies and Procedures Manual
Page 34 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 444 Storage amp Handling Per Unit CDC Recommended Temperature Monitoring Device
Question 44 Assess the temperature monitoring device in this section of the storage unit to answer the questionsbelow
A Is the temperature monitoring device a continuous monitoring and recordingdevice (eg data logger)
Yes No [O] (Skip D)
B Does the temperature monitoring device have a probe in buffered material Yes No [O]
C Does the temperature monitoring device have a digital display that can beeasily read from the outside of this unit
Yes No [O]
D Is data downloaded and reviewed routinely Yes No [O]
Review CDC Recommendation
As of Jan 1 2018 all VFC providers must use continuous temperature monitoring devices (eg data loggers) to monitor vaccinesthat will be administered to VFC-eligible children Routine review and accessibility of temperature data is critical for determining whether vaccine has been properly stored and for assessing usability of vaccine that was involved in a temperature excursion Tomeet VFC Program requirements the device must also be equipped with bull A temperature probe bull An active temperature display that can be easily read from the outside of the unit bull The capacity for continuous monitoring and recording capabilities where the data can be routinely downloaded
The following are additional recommended features for these devices bull Alarm for out-of-range temperatures bull Current minimum and maximum temperatures display bull Low battery indicator bull Accuracy of +- 1degF (05degC) bull Memory storage of at least 4000 readings bull User programmable logging interval (or reading rate) recommended at a maximum time interval of every 30 minutes bull Use of a probe that best reflects the temperature of the vaccine (such as a buffered probe)
Goal of this question Assess the temperature monitoring device in the storage unit Note that these are all recommendations not requirements at this time
This is a great teaching opportunity for sites who do not currently have a continuous temperature monitoring device Beginning Jan 1 2018 all units that store MnVFC vaccine will be required to have a continuous temperature monitoring device (ie a data logger or a continuous temperature monitoring system) Unlike a minmax thermometer a continuous temperature monitoring device provides detailed information on all temperatures recorded at pre-set intervals For excursions it can provide information on when a temperature went out-of-range for how long and what the temperatures were This is essential information that vaccine manufacturers need to know to assess the viability of the vaccine following an excursion
Helpful information bull Sites are required to monitor and record temperatures twice daily however temperature excursions can easily occur in the 12 hours or longer between readings Continuous temperature monitoring can help manufacturers determine vaccine viability
bull Continue to encourage sites to document and evaluate minimum and maximum temperatures the storage unit reached since the last reading and respond appropriately to out-of-range temperatures
IPI Advisor Manual | February 2017 Page 35
The 2017 MnVFC Site Visit Paperwork Chapter 4
bull It is recommended that sites download and review data weekly Discuss with sites that reviewing temperature monitoring device data also includes responding appropriately if they identify out-of-range temps
bull There is sometimes confusion about the difference between a data logger and a continuous temperature monitoring system Here are some differences
Data Loggers Continuous Monitoring Systems Have an external display similar to thermometers May or may not have an external display Have a detachable probe Probe is usually attached to transmitter Need to be plugged into the computer or cradle to download information on a regular schedule
Wirelessly sends data to computer system
Create a file of data that needs to be saved on the computer
Data is stored within the system not a separate file
Doesnrsquot allow documentation of twice a day temperature checks in the file
May allow documentation of twice a day temperature checks within the system
More about the 2018 requirement for a continuous temperature monitoring device
Required Features bull The continuous temperature monitoring device must have Continuous monitoring and recording capabilities to track and record temperatures over time The capacity to routinely download temperature data to a computer (recommended at least weekly) or wirelessly transmit data Detachable probe in a bottle filled with a thermal buffer (eg bio-safe glycol) if the data logger needs to be detached in order to download data Active temperature display
Recommended Features bull MnVFC recommends continuous temperature monitoring devices with Alarm for out-of-range temperatures Accuracy within +-1degF (+- 05degC) Low battery indicator Display of current minimum and maximum temperatures Memory storage of at least 4000 readings User programmable logging intervals (eg the user can set how often the device records the temperature)
Note that these are all currently recommendations not requirements yet
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Page 36 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 45
Goal of this question Ensure the temperature monitoring device is properly calibrated The certificate of calibration testing means that the device has been tested and it is accurately measuring temperatures within established testing limits The certificate of calibration ensures that the device meets all the required components
Helpful information bull The provider is always responsible for having a current certificate of calibration (or copy) on-site
bull To be considered ldquovalidrdquo a certificate of calibration must contain these required elements Modeldevice name or number Serial number
4 Storage amp Handling Per Unit Certificate of Calibration Testing
Review CDC Requirement
Certificates of calibration testing provide confidence that the temperature monitoring device is measuring temperaturesaccurately All units storing VFC vaccines must have a calibrated temperature monitoring device with a current and valid certificateof calibration testing All certificates must contain modeldevice name or number serial number date of calibration testing (report or issue date) and Instrument Passed testingInstrument in Tolerance (Recommended uncertainty = +-05ordm C (+-1ordm F))
Question 45
Note to Reviewer
A
B
C
D
E
Review the certificate of calibration testing for the temperature monitoring device in this section of the storage unit and answer the questions below
bull How to determine certificate of calibration testing expiration date 1) Identify the certificate issuecalibration date 2) Apply the Immunization Program-required frequency for calibration testing Example If the
issuecalibration date is 12312013 and Immunization Program policy requires testing every twoyears the expiration date is 12312015
bull Certificates must include all of the below bull ModelDevice Name or Number bull Serial Number bull Date of Calibration Testing (Report or Issue Date) bull Instrument Passed testing (Instrument in Tolerance)
Is there a certificate of calibration testing for the temperature monitoring Yes device in this section of the storage unit No [X]
What is the date of calibration for the temperature monitoring device in this section of the storage unit
What is the certificatersquos date of expiration based on ImmunizationProgram policy (See note to reviewer to determine expiration date) [X] Follow-up is required if
certificate is expired
Does the certificate contain all the necessary items listed in the Note to Yes Reviewer No [X]
Who is responsible for supplying the current and valid certificate of Provider calibration for this temperature monitoring device
Date of calibration testing (report or issue date) Note If there is no expiration date the certificate expires 2 years from the date of calibration Whether the instrument passed or failed testing (or instrument in tolerancenot in tolerance)
bull Recommended element Documented uncertainty of +- 1degF [05degC]
If these elements are present the certificate is considered valid If the certificate contains information about the recommended element or the entity that issued the certificate that is helpful but not required
To determine if a certificate of calibration testing was issued by an appropriate entity check to see if the certificate indicates one or more of these items (this is the wording used to help sites evaluate if their calibration is accurate but is not required on the certificate itself to be considered valid)
bull Conforms to ISO 17025 bull Performed by an ILACMRA Signatory body accredited laboratory You can review this list of the ILAC MRA and Signatories (httpilacorgilac-mra-and-signatories)
bull Traceable to the standards maintained by NIST bull Meets specifications and testing requirements for the American Society for Testing and Materials (ASTM) Standard E2877 tolerance Class F (le 05 degC) or better
bull Includes reference to another acceptable accuracy validation method such as comparison to other traceable reference standards or tests at thermometric fixed points
Note CDC recommends that certifications be issued for the entire monitoring unit (detachable probe data logger etc) and not individual certificates for each component
IPI Advisor Manual | February 2017 Page 37
The 2017 MnVFC Site Visit Paperwork Chapter 4
For 45 E the provider is always responsible for supplying the current and valid certificate of calibration for a temperature monitoring device
bull Tip If the temperature monitoring device has a sticker on the back with the calibration date the site can usually call the company who calibrated the device and get a copy of the certificate if they donrsquot have one
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 46 4 Storage amp Handling Per Unit Probe Placement
Question 46 Is the probe properly placed in this section of the storage unit
Note to Reviewer ldquoProperlyrdquo means that the probe in a commercial or household unit is placed in a central area of the unitdirectly with the vaccines Probes should not be placed in the doors near or against the walls close to vents or on the floor of the unit The only allowable exemption related to this requirement is for providerswho have pharmaceutical storage units (built for vaccine storage) that have either (1) a built-intemperature monitoring device OR (2) a dedicated port for the probe that dictates the placement of theprobe
Answers (Choose one)
Yes No [X]
Review CDC Requirement
The probe must be placed in a central area of the section of the storage unit directly with the vaccines in order to properly measurevaccine temperature The probe should not be placed in the door near or against the walls close to vents or on the floor of theunit For pharmaceutical units with a built-in temperature monitoring device or a dedicated port for a probe that is not in thecenter of the section of the storage unit consult your Immunization Program for guidance on placement
Goal of this question Make sure the temperature monitoring device is in the best location to accurately measure the temperature of the vaccines stored in the unit
Helpful information bull The probe of the temperature monitoring device should be placed directly with the vaccines in the middle of the unit The ONLY allowable exception is for pharmaceutical storage units that have either a built-in thermometer or a dedicated port for the probe that indicates placement of the probe
bull Temperatures can vary within the unit especially household units bull Call MDH at 651-201-5522 if you have questions
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Guide (wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml)
Page 38 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 474 Storage amp Handling Per Unit Temperature Documentation
Question 47 Review the temperature documentation over the past three months for this section of the storage unit todetermine whether the provider has a process in place for properly documenting temperatures twice aday Answer the questions below
A Are there two temperature readings recorded for this section of the storage unit per day
Yes No [X]
B Is there a time date and name (or initials) recorded for each reading Yes No [X]
C What is the current temperature and minmax temperatures (if available) inthis section of the storage unit Use the reviewerrsquos thermometer if the providerrsquos temperature monitoringdevice does not have a current valid certificate of calibration testing or the probe is not properly placed in this section of the storage unit
Current Temperature Minimum Temperature Maximum Temperature Fahrenheit Celsius
D Based on your review of the providerrsquos recent temperature documentationincluding the current temperature is this section of the storage unitmaintaining appropriate temperatures
Yes No [X] Not enough information [X]
Review CDC Requirement
Vaccines must be stored under appropriate temperatures as described in the package inserts at all times Acceptable temperature ranges vary by vaccine type and the range is 36deg F and 46deg F (2deg C and 8deg C) and for frozen vaccines the range is -58deg F and +5deg F (shy50deg C and -15deg C) Exposure to temperatures outside of those included in the package inserts could affect vaccine viability andultimately could leave children unprotected against vaccine-preventable diseases In order to maintain awareness of storage unittemperatures and ensure that vaccines are being stored at appropriate temperatures at all times VFC providers are required to monitor and document temperatures for all vaccine storage units at least twice a day Temperature documentation must contain (1) at least two temperature readings per day (2) the time and date of each reading and (3) the name (or initials) of the personwho assessed and recorded the readings CDC also recommends that VFC providers record the minimum and maximumtemperatures of each unit once each workday (preferably in the morning)
Goal of this question Ensure the temperature is being monitored twice daily is within the required range and documented correctly Use your thermometer to check the temperature if the sitersquos temperature monitoring devicersquos probe is not properly placed or there is not a current certificate of calibration Place your thermometer in the unit at the beginning of the visit to allow sufficient time to reach an accurate temperature The purpose of using your thermometer is to ensure the vaccine is being stored at the proper temperature not to ldquovalidaterdquo their reading
Question 47 D is an assessment question based on information you have learned during your visit You might answer ldquonot enough informationrdquo if the unit is new and they donrsquot have at least three months of data or if the unit is only used as overflow and they are inconsistent with temperature monitoring Mark ldquoNordquo if you have reason to believe the storage unit is not maintaining temperatures properly
Helpful information bull All sites must document temperatures twice a day every day the site is open even if they have a data logger or continuous monitoring system
bull Sites can document the information electronically with some continuous monitoring systems as long as it can show what the current temp is the date time and initials of the person checking ndash this needs to be someone at the site ndash not checking remotely or centrally for a large site or system The site must be able to produce these records during their site visit Reviewing these files can be a challenge due to large volumes and lots of paper
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Temperature Logs on Managing Vaccine (wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml)
IPI Advisor Manual | February 2017 Page 39
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 484 Storage amp Handling Per Unit Temperature Excursions
Question 48 In the event that a temperature excursion(s) occurred in this unit within the last three months requestand review documentation of actions taken to determine whether the provider has a process for properlyaddressing excursions Answer the questions below
A Were vaccines in this unit exposed to out-of-range temperatures in the lastthree months (including today)
Yes No (If no skip to question 49)
B Did the provider quarantine and label vaccines as ldquoDo not userdquo Yes No [X]
C Did the provider place vaccine in a unit where it can be stored under properconditions if applicable
Yes No [X]
D Did the provider contact the Immunization Program to report theexcursion
Yes No [X]
E Was the manufacturer contacted for documentation supporting theusability of the vaccine
Yes No [X]
Review CDC Requirement
The provider must document all excursions and actions taken including the following (1) Quarantine and label vaccines as ldquoDO NOTUSErdquo (2) Place vaccines in a unit where they can be stored under proper conditions (3) Contact the Immunization Program to report an excursion and (4) Contact the vaccine manufacturer to obtain documentation supporting the usability of the vaccine
Goal of this question Address any out-of-range temperatures (temperature excursions) identified in reviewing the last three months of temperature logs or during the site visit If there were any out-of-range temperatures did the site respond appropriately to the situation This is a great opportunity to discuss what to do in the event of an excursion The Clinicians Storage and Handling Mishap Checklist is in the IPI Site Visit information folder and is a good review of the process
Helpful information bull Sites need to know that an excursion does not automatically mean that exposed vaccines are non-viable or unusable Exposed vaccines must be quarantined (marked ldquoDo Not Userdquo) and stored under proper conditions until they have received information from vaccine manufacturers regarding the viability of the vaccine
bull Sites must inform MDH when an excursion occurs
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Clinicians Storage and Handling Mishap Checklist (wwwhealthstatemnusdivsidepcimmunize ipivaxchklstpdf)
Page 40 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 49
Goal of this question Ensure proper placement of vaccines in the storage unit
Note These are all recommendations (best practices) not requirements
Helpful information bull Store vaccine in the middle of the compartment two to three inches away from the coils walls floor and cold air vent The temperature near the floor and walls of the unit differs from that in the middle of the compartment and the cold air vent can freeze refrigerated vaccines
4 Storage amp Handling Per Unit Vaccine Placement
Question 49 Look inside the unit to answer the questions below
A Are vaccines placed in the middle of the unit with space between vaccinesand the sideback of the unit to allow cold air to circulate
Yes No [O]
B Are vaccines stored in their original packages Yes No [O]
C Are there water bottles (for refrigerators) or frozen water bottles (forfreezers) in the unit
Yes No [O]
D Are vaccines store in the doors vegetable bins under or near cooling ventsor on the floor of the unit
Yes [O] No
E Is food being stored in the unit Yes [O] No
Review CDC Recommendation
Vaccines should be stored in their original manufacturer (or CDC centralized distributor) packaging They should be placed in the middle of the unit with space between the vaccines and the sideback of the unit to allow cold air to circulate Vaccines SHOULD NOT be stored in the doors vegetable bins or floor of the unit or under or near cooling vents and there should not be any food inthe unit Water bottles (for refrigerators) or frozen water bottles (for freezers) should be placed throughout each storage unit inorder to (1) stabilize or extend temperatures during a power outage and (2) to serve as physical blocks preventing the placementof vaccines in areas of the unit that are at higher risk for temperature excursions (such as in doors vegetable bins floor ornearunder cooling vents)
bull Vaccines should be kept in their original packaging to Protect them from light Help prevent medication errors by making labels easier to read Provide a moisture barrier that serves as insulation in case of an out-of-range temperature power outage door left open or mechanical failure Simplify managing vaccine inventory
bull Store water bottles in the doors on the floor and near the cold air vent in the refrigerator and frozen water bottles in the freezer to help maintain a stable temperature if there is a power failure and when the door is opened frequently Too many water bottles in the door can prevent the door from closing tightly Mark water bottles ldquoDo Not Drinkrdquo
bull Do not store vaccine in the door or drawers of the refrigerator or freezer Vegetable bins and crisper drawers should be removed from refrigerators or used to store other medical supplies or water bottles
bull If vaccine is stored in a household combination refrigeratorfreezer The top shelf should not be used for storing vaccine because the cold air vent blowing from the freezer will freeze vaccine located there If you must use the top shelf of this type of unit place water bottles underneath the cold air vent to prevent vaccine from being stored there It is recommended that only the refrigerator be used for vaccine storage and a separate stand-alone freezer be used to store frozen vaccine
bull Must not store food or beverages in the refrigerator or freezer because frequent opening of doors can lead to temperature variations that may affect vaccine viability There is also a risk of contaminating vaccines
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Guide (wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml) bull Vaccine Storage Tip Sheet on IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml)
IPI Advisor Manual | February 2017 Page 41
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 4104 Storage amp Handling Per Unit Disconnection from Power Source
Question 410 Ask the provider to demonstrate what measures are taken to ensure that vaccine storage units are notaccidentally physically disconnected from the power supply Which of the following describes the measure(s) taken on this unit
Note to Reviewer bull Large hospitals and healthcare systems may not have the ability to demonstrate labels on plugs or circuitbreakers In such cases verify that the practice has a comprehensive policy and standard operatingprocedures in place to prevent the vaccine storage unit from being physically disconnected from thepower supply
bull While back-up generators may ensure power to the overall facility this question ONLY addresses thevaccine storage unit being accidentally disconnected from the power source either through the plug orthe circuit breaker
Answers A ldquoDo not disconnectrdquo labels on the plug (Choose all that B ldquoWarningrdquo label on the circuit breaker box
apply) C Hard-wired (ie built-in) and has a ldquoDo not disconnectrdquo label on thecircuit breaker box D Hospital or large health care system with a comprehensive written policyand standard operating procedures detailing measures taken to preventvaccine storage units from being accidentally disconnected from the powersupply E No acceptable measures for preventing accidental disconnection frompower supply [X]
[X] The response is non-compliant if only A only B or E is selected
Review CDC Requirement
VFC providers must take steps to protect the power source for all vaccine storage equipment by means of having clear warninglabels on both the plug and the circuit breaker associated with all vaccine storage units Large hospitals and healthcare systems canmeet this requirement by demonstrating that they have comprehensive policies and standard operating procedures to preventvaccine storage units from being physically disconnected from the power supply
Goal of this question Decrease the chance that a vaccine storage unit will be accidently unplugged or power will be turned off while vaccine is in the unit This question addresses only what measures the site has taken to ensure the storage unit is not physically disconnected from its power source
If the site uses labels on the plugs and circuit breakers perform a visual inspection to assess whether the way the stickers are positioned make it clear and obvious to anyone that these units are not to be disconnected
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Do Not Unplug and Warning stickers are included in the folder or available to order on the For
Professionals Order Form (wwwhealthstatemnusdivsidepcimmunizeordermathtml)
Note Once you have completed the 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet for each unit return to the questionnaire to complete sections 5 and 6
Page 42 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
- -
Section 5 Storage amp Handling Site-Wide Question 51
5 Storage amp Handling Site Wide Discussion of Cost amp Quantity of Vaccine
Question 51 Have a discussion with the provider about the cost and quantity of VFC vaccines they are responsible for annually Address the points listed in the note to reviewer below
Note to Reviewer bull Vaccine Shipped (Required) Share the cost of VFC vaccines shipped to the provider in the last calendaryear to make sure the provider understands the contribution made by the VFC Program to their practiceFor new providers who do not have ldquocalendar yearrdquo data share either the actual cost of their currentinventory or use the cost of 10 VFC doses of each of the ACIP-recommended vaccines (approximately $7000) to help estimate their annual cost
bull Storage amp Handling (Required) Make sure the provider understands the cost of vaccines for which they are responsible when they make decisions about purchasing recommended vaccine storage and temperature monitoring equipment
Answer I have discussed with the provider the cost and quantity of vaccines ordered in the previous calendar year
Goal of this question Inform sites of the quantity and value of vaccines that they receive as part of the MnVFC program Providers often donrsquot realize the value of the vaccine in their unit This information is included on your clinic list and on the one page site-specific information
Helpful information bull This discussion must occur and the box on the questionnaire must be checked bull If there isnrsquot actual vaccine value information available tell the site that one vaccine order that includes a box of each of the ACIP recommended vaccines costs approximately $7000
bull MDH may not have specific information for individual sites if they receive vaccine from a central warehouse or pharmacy For those sites MDH will give you numbers for the whole system so you can discuss system wide data as appropriate If individual site information is also included it is usually just varicella-containing vaccines that must be shipped directly to the site
Question 52
5 Storage amp Handling Site Wide Dorm Style Units
Question 52 Determine whether the provider has any dorm-style units on site and answer the questions below
Note to Reviewer A dormitory-style refrigerator is a unit that has both refrigerator and freezer compartments behind a singleexterior door Dorm-style units also have an evaporator plate (cooling coil) which is usually located insidean icemaker compartment (freezer) within the refrigerator
A Does the provider have any dorm-style units that are used at any time tostore vaccines
Yes [X] No (Skip to question 53)
B Does the provider have sufficient space in existing compliant vaccinestorage units to store all vaccines without use of the dorm-style unit at any time
Yes No [X]
Review CDC Requirement
Dorm- and bar-style units are prohibited for vaccine storage Vaccines stored in dorm-style units are considered non-viable and must be returned to the centralized distributor CDC recommends the following vaccine storage unit types (in order of preference)pharmaceutical grade stand-alone or combination units (preferred) householdcommercial stand-alone unitshouseholdcommercial combination units using the refrigerator section only
Goal of this question Ensure no vaccine is stored in dorm-style units even for short periods of time Encourage them to label any units ldquoNo Vaccine Storage Allowedrdquo Vaccine stored in these units is considered non-viable If a site is using a dorm-style unit call the MnVFC program (651-201-5522)
Resource Section 8 in the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 43
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 535 Storage amp Handling Site Wide Storage Unit Space Availability
Question 53 Does the provider have sufficient room across storage units to store current stock as well as anyadditional stock acquired during peak season without overcrowding
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have sufficient storage space to accommodate vaccine stock at the busiest time of year without overcrowding
Goal of this question Ensure that sites have sufficient space in their units to maintain vaccines at the busiest time of year Overcrowding of vaccine limits air circulation and affects the unitrsquos ability to maintain stable temperatures
Helpful information bull Look for signs of overcrowding such as vaccines that are pushed up against the wall bins that are overflowing or storage units that are full during non-peak seasons
Discuss immediate actions if the unit is overcrowded Move some of their vaccines order less vaccine more frequently (once per month preferably) andor purchase another storage unit for overflow
Resource bull Section 8 MnVFC Policy and Procedure Manual
Page 44 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 545 Storage amp Handling Site Wide Expired Vaccines
Question 54 Look in each unit Are there expired vaccines in any of the vaccine storage units at this site
Answers (Choose one)
Yes [X] No
Review CDC Requirement
Vaccines should be rotated weekly and when a new shipment comes in so that longer-dated vaccines are stored behind shorter-dated vaccines If vaccines expire they can no longer be stored in the same storage unit with viable vaccines They must be placedin a container or bag clearly labeled ldquoDo not userdquo and separated from viable vaccines to prevent inadvertent use Expired vaccinemust be returned to the centralized distributor within six months of expiration
Goal of this question Ensure there is no expired vaccine in any storage unit
Helpful information bull Sites can prevent their stock from expiring by rotating vaccines every week andor when a new shipment arrives Longer-dated vaccines are stored towards the back of the unit and shorter-dated vaccines are up front
bull Pay attention to vaccines that expire within the next three months Consider transferring vaccine that will expire soon to another MnVFC-enrolled site that will use the vaccine preferably a site close by It is the transferring sitersquos responsibility to arrange the transfer of the vaccine Be sure to complete the MDH Vaccine Transfer Record form and send it to MDH If they are having difficulty finding a location to accept vaccine contact MDH
bull This is a great opportunity to educate sites about the MDH Nonviable Vaccine Form and the process for returning vaccine The VFC program does get some credit for taxes and fees on vaccine that is returned to the distribution center
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MDH Nonviable Vaccine Form and MDH Vaccine Transfer Record on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfcformshtml)
IPI Advisor Manual | February 2017 Page 45
The 2017 MnVFC Site Visit Paperwork Chapter 4
- -
-
Question 555 Storage amp Handling Site Wide Back up Thermometer
Question 55 Does the provider have a readily available back-up thermometer with a current and valid certificate ofcalibration testing
Note to Reviewer ldquoReadily availablerdquo means that the thermometer is available to perform twice-a-day monitoring for a unit asrequired CDC recommends that the back-up thermometer be maintained on site
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have a readily available back-up thermometer with a current and valid certificate of calibration testing Toprevent the certificates of calibration testing of the primary and back-up thermometers from expiring at the same time the date of calibration testing (or issue date) of the back-up thermometer should be different from the date of calibration testing (or issue date) of the primary thermometer As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meetsVFC program requirements
Goal of this question Ensure sites have one calibrated back-up thermometer onsite that is readily available in the event that the temperature monitoring device in unit fails transportation of vaccine is needed or there are other unexpected circumstances
Helpful information bull As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meets VFC Program requirements
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 56 5 Storage amp Handling Site Wide Preparation of Vaccine
Question 56 When does this provider prepare vaccine for administration to the patient
Note to Reviewer For mass vaccination clinics if one type of vaccine is offered providers may pre-draw up to 10 doses Ifusing pre-filled syringes pre-drawing also means activating the syringe by removing the needle guard orattaching a needle
Answers (Choose all that
apply)
Prepare dose immediately before administration Pre-draw doses for upcoming patients (in a regular clinicpractice) [O] Pre-draw up to 10 doses (in a mass-vaccination clinic) Pre-draw more than 10 doses (in a mass-vaccination clinic) [O] Other [O]
Review CDC Recommendation
CDC recommends preparing vaccines immediately prior to administration in order to assure viability of vaccine and prevent vaccinewastage Vaccines that are not administered immediately are at risk of exposure to temperatures outside of the required rangewhich can affect vaccine viability and ultimately can leave children unprotected against vaccine-preventable diseases
Goal of this question Discuss proper timing and preparation of vaccine(s) for administration These are recommendations not requirements
Helpful information bull Educate staff on the importance of preparing vaccine immediately before administration Pre-drawing of vaccines may lead to concerns related to vaccine viability potency sterility and wastage
Page 46 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 6 Inventory Question 61
6 Inventory Inventory Comparison
Question 61 Visually inspect storage units to determine if existing supply of vaccines proportionately mirrorspopulations served Choose the most accurate statement below
Note to Reviewer bull CDC recommends that providers maintain a four-week supply of inventory bull For this question do not take into account vaccine types that the provider does not order Here simply
make sure that overall the vaccines in the providerrsquos storage units are available in sufficient amounts toserve their patient population
Answers (Choose one)
The current vaccine inventory proportionately reflects the populations identified Only public stock is insufficient [X] Only private stock is insufficient [X] Both public and private stock are insufficient [X] Site uses the replacement method but does not appear to have enough vaccine for their population [X] Other [X]
Review CDC Requirement
VFC providers must order and stock routine vaccines in accordance with their patient population in order to prevent missedvaccination opportunities Having sufficient amounts of all stocks prevents the inadvertent use of VFC vaccines for non-VFC-eligiblepatients and vice versa
Goal of this question Assess whether the site is ordering appropriate quantities of vaccine for the population they serve at their site
Helpful information bull If the site sees 30 percent private-pay patients and 70 percent VFC the stock in their storage units should reflect that proportion If you donrsquot know you can ask the site about their population
bull This is meant to be a general assessment so in a big site if they have only a small amount of vaccine that may indicate an issue with vaccine management
bull CDC recommends smaller more frequent orders (ie monthly) rather than large orders to minimize the amount of vaccine loss if an incident occurs during shipment or in the storage unit Sites should not order more frequently than once a month
bull Sites using the replacement method will only have one stock but it should appear to be large enough for their population
bull Only assess the vaccine types that the site currently stocks in their unit We know there are sites that do not offer all ACIP-recommended vaccines for various reasons That issue will be addressed in question 62
IPI Advisor Manual | February 2017 Page 47
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 626 Inventory ACIP Recommended Vaccines
Question 62 Review providerrsquos current inventory to answer the questions below
A Does the provider offer all routine ACIP-recommendedvaccines for their patient population
Yes (Skip to question C) No [X] Offers all except varicella because direct ship ofvaccine is unavailable from manufacturer
B Which routine vaccines are NOT being offered DTaP Hepatitis A Hepatitis B HIB HPV Influenza Meningococcal
MMR Pneumococcal Polio Rotavirus TdapTd Varicella
C According to Immunization Program Policy does theprovider make accessible all non-routine ACIP-recommended vaccines for those VFC patients whomeet the criteria for receiving them
Yes (Skip to question 63) No [X]
D Which non-routine vaccines are NOT being offered Pneumococcal polysaccharide vaccine (PPSV23) Meningococcal Group B (MenB) Other
Review CDC Requirement
VFC providers agree to comply with immunization schedules dosages and contraindications that are established by the Advisory Committee on Immunization Practices (ACIP) for the vaccines identified and agreed upon in the Provider Agreement UNLESS bull In the VFC providers medical judgment and in accordance with accepted medical practice the VFC provider deems such
compliance to be medically inappropriate for the child bull The particular requirements contradict state law including laws pertaining to religious and other exemptions The VFC program entitles children to the following vaccines DTaP Hepatitis A Hepatitis B HIB HPV Influenza MeningococcalMMR Pneumococcal Polio Rotavirus TdapTd and Varicella VFC providers are also required to ensure that VFC-eligible children have access to non-routine vaccines as needed
Goal of this question Assess if the site is offering all the ACIP-recommended vaccines for the population they serve and these vaccines are in stock on the day of the visit It is important that every MnVFC-eligible child that comes to a providerrsquos office for an immunization is vaccinated
Helpful information bull The Advisory Committee on Immunization Practices (ACIP) is a group of medical and public health experts that develops recommendations on how to use vaccines to control diseases in the United States
bull Specialty providers are not required to offer all routine vaccines but should provide the vaccines appropriate for their population
bull If the site does not offer all routine ACIP-recommended vaccines appropriate for their population check the ldquoNordquo box in Part A then check the appropriate box(es) in Part B for any vaccines not offered Please contact MDH as this situation offers us the opportunity to provide education to the site
bull For non-routine vaccines they must either be in stock or the site must have an alternative protocol in the routine management plan that ensures these children have access when applicable
Resources bull IAC Diseases and Vaccines (wwwimmunizeorgvaccines) bull CDC Advisory Committee on Immunization Practices (ACIP) (wwwcdcgovvaccinesacipindexhtml)
Page 48 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 636 Inventory Separation of Stock
Question 63 Observe how the provider differentiates stock in each storage unit to answer the questions below
A Is it clear which vaccines belong to public stock andwhich belong to private stock
Yes No [X] Not applicable replacement site
B Is it clear which vaccines belong to VFC stock andwhich belong to UUAV stock
Yes No [X] Not applicable replacement site Not applicable not UUAV-enrolled site
Review CDC Requirement
In order to ensure that VFC vaccines are only administered to VFC-eligible children VFC providers that serve both VFC and non-VFCshyeligible children must maintain their vaccine inventories in such a way that they can clearly differentiate public stock from privatestock as well as VFC from other public stock
Goal of this question Assess whether the site can distinguish between MnVFC vaccine and private vaccine If they participate in the Uninsured and Underinsured Adult Vaccine (UUAV) program they should also be able to distinguish between MnVFC stock and UUAV stock Some sites use labels bins boxes etc to differentiate their stock If it is not clear how the site differentiates their stock discuss vaccine management with the staff For follow-up call MDH to discuss doing a follow-up site visit
Sites using the replacement method will not have separate stocksmdashthis is an approved alternative method for keeping track of vaccine
Resource bull Section 10 of the MnVFC Policy and Procedure Manual
IPI Advisor Manual | February 2017 Page 49
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
MnVFC Site Visit Storage and Handling Per Unit Answer Sheet 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet MnVFC PIN ___________________
Question number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
Temperature Monitoring Device Questions Questions 43 47 must be answered separately for the freezer and refrigerator if the unit is a combo Be sure to document responses in the appropriate column
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
All the questions on the Site Visit Storage amp Handling Per Unit Answer Sheet have been discussed previously in section 4 of this manual Use this sheet to record information about all the units at the site visit You will need one sheet for each unit If it is a combination unit (either pharmaceutical or household) you can record both sections on one sheet If they have stand-alone units use one sheet for each unit Do not enter the answers to the questions in section 4 of the questionnaire
If you need more information about any of the questions refer back to the main questionnairemdashthe complete question additional guidance including notes to the reviewer and the CDC requirements are there Also if the site is not meeting the requirement you will go back to the questionnaire to complete the ldquoActions if Non-compliantrdquo section including the root cause analysis and follow-up sections
When you have completed the assessment of all the storage units remember to go back to the questionnaire to complete sections 5 and 6
Page 50 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
ndash
ndash
MnVFC Provider Follow-up PlanThe goal of the Provider Follow-up Plan is to communicate with the site all of the VFC requirements any unmet requirements found during your site visit and the timeline for completing the required action The left hand column is a box to check for ldquoUnmetrdquo requirements
Helpful information bull The form can be used to review what the site is doing well and what they need to work on
bull For requirements that have specific documentation that needs to be sent to you use the notes section
2017 MnVFC Provider Follow-up Plan Site _______________________________________________ MnVFC PIN ____________ Date of Visit ___________
Thank you for participating in this MnVFC compliance site visit Please review this visit summary including follow-up actions and timelines for completion Unmet MnVFC requirements and recommendations have a checked box next to them The goal of this plan is to support you with successfully implementing the program and improving access to vaccines for VFC-eligible children
Unmet Question VFC Requirements Section 1 Changes to Key Staff
Q12 Change in the Medical Director Immunization Manager Vaccine Coordinator or back-upKey Staff must be communicated to the immunization program by emailing healthmnvfcstatemnus Changes Notes
Q12 Key staff must complete the annual training on VFC program requirements and print theAnnual Training certificate of completion Documentation Required Action
Staff that have not completed the MnVFC online training must complete it and send acopy of the certificate to the reviewer Training can be found on the MnVFC website (wwwhealthstatemnusvfc) Due date 1 month
Notes
Unmet Question VFC Requirements Section 2 Eligibility
Q21 Provider staff must possess a working knowledge of all VFC eligibility criteria and use thoseVFC Eligibility criteria to screen children prior to administering VFC vaccines
Categories Notes
bull This form provides documentation needed for follow-up actions when you send your thank you email
The second to last page of the Provider Follow-up Plan has a summary of the MnVFC program recommendations These are to remind the site about best practices they may want to improve upon even though they are not yet requirements of the program For example you could discuss the recommendation about storage units if they currently have a combination household unit and are using both sections
The last section is for your signature and the person you met with In most sites it will be the immunization manager or vaccine coordinator who signs the form unless the medical director attended the site visit You keep the original copy and the site will need to keep a copy for themselves
To be completed by the site visit reviewer
I acknowledge that a VFC site visit was performed on __________________ (visit date) The follow-up plan which includes a list of all current VFC program requirements and recommendations assessed during the visit and any required follow-up actions was provided at the end of the visit
Site visit reviewer
Phone
Reviewer Signature Date
To be completed by the provider
I acknowledge that our practice took part in the VFC site visit noted above I understand the findings of the visit and any required actions that must be taken by our office in order to meet VFC program requirements
Medical Director (or designee) Name Title
Medical Director (or designee) Signature Date
IPI Advisor Manual | February 2017 Page 51
The 2017 MnVFC Site Visit Paperwork Chapter 4
After the Site Visit Send a thank you email highlighting the unmet requirements documents you need from the site to resolve the issue(s) and the date you need them Make sure to include the link to the Site Visit Survey (httpssurveyvovicicomseashxs=56206EE334CE0B14)
Please refer to Chapter 3 for more information about future follow-up required after the visit including forms and documentation
Resource bull Sample Thank You letter on IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml)
Chapter 5
IPI Advisor Resource List MnVFC Program 651-201-5522
MnVFC wwwhealthstatemnusvfc
bull Separate Stock and Replacement Method Policies and Procedures Manuals bull Online trainings bull MnVFC Announcements sign up to receive them via email bull Ordering MDH vaccine bull MnVFC forms Screening forms Reporting forms Others MDH Nonviable Vaccine Form MDH Vaccine Transfer Record and Vaccine Borrowing Report
bull MnVFC promotional materials bull Immunization Billing Guidance for MnVFC and Immunization Billing Guidance for MnVFC Replacement Sites Immunization Practices Improvement Program (IPI) wwwhealthstatemnusdivsidepcimmunizeipi
bull IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml) bull IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml) IPI Resource Folder Contents (wwwhealthstatemnusdivsidepcimmunizeipiipifolderpdf)
Minnesota Immunization Information Connection (MIIC) wwwhealthstatemnusmiic
bull MIIC regions and regional coordinators
Clinical Practice MDH Immunization Program wwwhealthstatemnusimmunize
Got Your Shots News wwwhealthstatemnusdivsidepcnewslettersgys
MDH Immunization Information for Health Care Providers wwwhealthstatemnusdivsidepcimmunizehcp
bull Got Your Shots A Providers Guide to Immunization in Minnesota bull Vaccine protocols bull Forms for tracking patient immunizations bull Immunization schedules for Health Care Providers Immunization Action Coalition (IAC) wwwimmunizeorg
bull Ask the Experts bull VISs (Vaccine Information Statements and translations) bull Administration screening questions bull Medical management of vaccine reactions bull Order form for Californiarsquos Immunization Technique DVD Best Practices with Infants Children and Adults
Page 52 IPI Advisor Manual| February 2017
IPI Advisor Resource List Chapter 5
CDC ldquoPink Bookrdquo wwwcdcgovvaccinespubspinkbookindexhtml
CDC Advisory Committee on Immunization Practices (ACIP) wwwcdcgovvaccinesacip
CDC Vaccines and Immunizations wwwcdcgovvaccines
VAERS reporting httpvaershhsgovindex
Storage and Handling Got Your Shots Providers Guide ndash Managing Vaccine wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml
MnVFC Guide to Temperature Monitoring Devices wwwhealthstatemnusvfc
MDH Clinicianrsquos Vaccine Mishap Checklist wwwhealthstatemnusdivsidepcimmunizeipivaxchklstpdf
MDH Vaccine Storage Guide wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml
CDC Vaccine Storage and Handling Toolkit wwwcdcgovvaccinesrecsstoragetoolkit
You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Vaccine manufacturer phone numbers wwwcdcgovvaccinespubspinkbookdownloadsappendicesFcontact-info-manufactpdf
IAC Checklist for Safe Vaccine Handling and Storage wwwimmunizeorgcatgdp3035pdf
IAC Donrsquot Be Guilty of These Errors in Vaccine Storage and Handling wwwimmunizeorgcatgdp3036pdf
Additional Resources Print materials from MDH ndash order forms wwwhealthstatemnusdivsidepcimmunizeordermathtml
Vaccine Education Center ndash Childrenrsquos Hospital of Philadelphia wwwchopeduservicevaccine-education-centerhomehtml
California Department of Public Health ndash Interactive training on vaccine administration and storage and handling handout on transporting vaccine and how to package wwwezizorg
IPI Advisor Manual | February 2017 Page 53
IPI Advisor Resource List Chapter 5
CDC vaccine price list wwwcdcgovvaccinesprogramsvfcawardeesvaccine-managementprice-listindexhtml
Vaccine Information Statements (VIS) wwwcdcgovvaccineshcpvisindexhtml
CEU Opportunities CDC Immunization Education and Training wwwcdcgovvaccinesedindexhtml
Immunization You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Page 54 IPI Advisor Manual| February 2017
- Introduction
-
- Welcome to the Immunization Practice Improvement (IPI) Program
- Contact Information
-
- Chapter 1
- Requirements to Participate in the MnVFC Program
- Vaccines for Children Program
- Chapter 2
- Reimbursement for MnVFC Visits
- Types of Visits
- Your MnVFC Clinical CoordinatorPlanner
- New IPI Advisor Training Requirements
- Your Role as an IPI Advisor
- Reasons MDH Would Do All or Part of a Visit
- Chapter 3
- Future follow-up
- Conducting the Visit
- Preparing for the Visit
- Information for the Visit
- Site Visit Checklist
- Scheduling the Visit
- Chapter 4
- After the Site Visit
- MnVFC Provider Follow-up Plan
- MnVFC Site Visit Storage and Handling Per Unit Answer Sheet
- Section 6 Inventory
- Section 5 Storage amp Handling Site-Wide
- Section 4 Storage amp Handling Per Unit
- Section 3 Documentation
- Section 2 Eligibility
- Section 1 Provider Details
- The Site Visit Reviewer Legend
- MnVFC Site Visit Questionnaire
- Required Paperwork for Site Visits
- Chapter 5
-
IPI Advisor Manual | February 2017 Page 33
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 434 Storage amp Handling Per Unit Temperature Monitoring Device in the Unit
Question 43 Determine whether there is a temperature monitoring device in this section of the storage unit andanswer the questions
A Is there a temperature monitoring device in this section of thestorage unit
Yes No [X] (If no skip to question 47)
B Who is responsible for supplying the temperature monitoring device in this section of the storage unit Provider
Review CDC Requirement
Certificates of calibration testing provide confidence that the temperature monitoring device is measuring temperaturesaccurately All units storing VFC vaccines must have a calibrated temperature monitoring device with a current and valid certificateof calibration testing All certificates must contain modeldevice name or number serial number date of calibration testing (report or issue date) and Instrument Passed testingInstrument in Tolerance (Recommended uncertainty = +-05ordm C (+-1ordm F))
Goal of this question Assess whether there is a temperature monitoring device in the unit If the unit is not being monitored at all call MDH at 651-201-5522 for guidance
Helpful information bull This question does not ask whether the temperature monitoring device is working or the characteristics of the device These issues will be addressed later in the questionnaire
bull For part B the provider is always responsible for supplying the temperature monitoring device Even if their thermometer or data logger was originally from MDH it is their responsibility to ensure it is functional and calibrated
Resources bull Section 8 in the MnVFC Policies and Procedures Manual
Page 34 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 444 Storage amp Handling Per Unit CDC Recommended Temperature Monitoring Device
Question 44 Assess the temperature monitoring device in this section of the storage unit to answer the questionsbelow
A Is the temperature monitoring device a continuous monitoring and recordingdevice (eg data logger)
Yes No [O] (Skip D)
B Does the temperature monitoring device have a probe in buffered material Yes No [O]
C Does the temperature monitoring device have a digital display that can beeasily read from the outside of this unit
Yes No [O]
D Is data downloaded and reviewed routinely Yes No [O]
Review CDC Recommendation
As of Jan 1 2018 all VFC providers must use continuous temperature monitoring devices (eg data loggers) to monitor vaccinesthat will be administered to VFC-eligible children Routine review and accessibility of temperature data is critical for determining whether vaccine has been properly stored and for assessing usability of vaccine that was involved in a temperature excursion Tomeet VFC Program requirements the device must also be equipped with bull A temperature probe bull An active temperature display that can be easily read from the outside of the unit bull The capacity for continuous monitoring and recording capabilities where the data can be routinely downloaded
The following are additional recommended features for these devices bull Alarm for out-of-range temperatures bull Current minimum and maximum temperatures display bull Low battery indicator bull Accuracy of +- 1degF (05degC) bull Memory storage of at least 4000 readings bull User programmable logging interval (or reading rate) recommended at a maximum time interval of every 30 minutes bull Use of a probe that best reflects the temperature of the vaccine (such as a buffered probe)
Goal of this question Assess the temperature monitoring device in the storage unit Note that these are all recommendations not requirements at this time
This is a great teaching opportunity for sites who do not currently have a continuous temperature monitoring device Beginning Jan 1 2018 all units that store MnVFC vaccine will be required to have a continuous temperature monitoring device (ie a data logger or a continuous temperature monitoring system) Unlike a minmax thermometer a continuous temperature monitoring device provides detailed information on all temperatures recorded at pre-set intervals For excursions it can provide information on when a temperature went out-of-range for how long and what the temperatures were This is essential information that vaccine manufacturers need to know to assess the viability of the vaccine following an excursion
Helpful information bull Sites are required to monitor and record temperatures twice daily however temperature excursions can easily occur in the 12 hours or longer between readings Continuous temperature monitoring can help manufacturers determine vaccine viability
bull Continue to encourage sites to document and evaluate minimum and maximum temperatures the storage unit reached since the last reading and respond appropriately to out-of-range temperatures
IPI Advisor Manual | February 2017 Page 35
The 2017 MnVFC Site Visit Paperwork Chapter 4
bull It is recommended that sites download and review data weekly Discuss with sites that reviewing temperature monitoring device data also includes responding appropriately if they identify out-of-range temps
bull There is sometimes confusion about the difference between a data logger and a continuous temperature monitoring system Here are some differences
Data Loggers Continuous Monitoring Systems Have an external display similar to thermometers May or may not have an external display Have a detachable probe Probe is usually attached to transmitter Need to be plugged into the computer or cradle to download information on a regular schedule
Wirelessly sends data to computer system
Create a file of data that needs to be saved on the computer
Data is stored within the system not a separate file
Doesnrsquot allow documentation of twice a day temperature checks in the file
May allow documentation of twice a day temperature checks within the system
More about the 2018 requirement for a continuous temperature monitoring device
Required Features bull The continuous temperature monitoring device must have Continuous monitoring and recording capabilities to track and record temperatures over time The capacity to routinely download temperature data to a computer (recommended at least weekly) or wirelessly transmit data Detachable probe in a bottle filled with a thermal buffer (eg bio-safe glycol) if the data logger needs to be detached in order to download data Active temperature display
Recommended Features bull MnVFC recommends continuous temperature monitoring devices with Alarm for out-of-range temperatures Accuracy within +-1degF (+- 05degC) Low battery indicator Display of current minimum and maximum temperatures Memory storage of at least 4000 readings User programmable logging intervals (eg the user can set how often the device records the temperature)
Note that these are all currently recommendations not requirements yet
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Page 36 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 45
Goal of this question Ensure the temperature monitoring device is properly calibrated The certificate of calibration testing means that the device has been tested and it is accurately measuring temperatures within established testing limits The certificate of calibration ensures that the device meets all the required components
Helpful information bull The provider is always responsible for having a current certificate of calibration (or copy) on-site
bull To be considered ldquovalidrdquo a certificate of calibration must contain these required elements Modeldevice name or number Serial number
4 Storage amp Handling Per Unit Certificate of Calibration Testing
Review CDC Requirement
Certificates of calibration testing provide confidence that the temperature monitoring device is measuring temperaturesaccurately All units storing VFC vaccines must have a calibrated temperature monitoring device with a current and valid certificateof calibration testing All certificates must contain modeldevice name or number serial number date of calibration testing (report or issue date) and Instrument Passed testingInstrument in Tolerance (Recommended uncertainty = +-05ordm C (+-1ordm F))
Question 45
Note to Reviewer
A
B
C
D
E
Review the certificate of calibration testing for the temperature monitoring device in this section of the storage unit and answer the questions below
bull How to determine certificate of calibration testing expiration date 1) Identify the certificate issuecalibration date 2) Apply the Immunization Program-required frequency for calibration testing Example If the
issuecalibration date is 12312013 and Immunization Program policy requires testing every twoyears the expiration date is 12312015
bull Certificates must include all of the below bull ModelDevice Name or Number bull Serial Number bull Date of Calibration Testing (Report or Issue Date) bull Instrument Passed testing (Instrument in Tolerance)
Is there a certificate of calibration testing for the temperature monitoring Yes device in this section of the storage unit No [X]
What is the date of calibration for the temperature monitoring device in this section of the storage unit
What is the certificatersquos date of expiration based on ImmunizationProgram policy (See note to reviewer to determine expiration date) [X] Follow-up is required if
certificate is expired
Does the certificate contain all the necessary items listed in the Note to Yes Reviewer No [X]
Who is responsible for supplying the current and valid certificate of Provider calibration for this temperature monitoring device
Date of calibration testing (report or issue date) Note If there is no expiration date the certificate expires 2 years from the date of calibration Whether the instrument passed or failed testing (or instrument in tolerancenot in tolerance)
bull Recommended element Documented uncertainty of +- 1degF [05degC]
If these elements are present the certificate is considered valid If the certificate contains information about the recommended element or the entity that issued the certificate that is helpful but not required
To determine if a certificate of calibration testing was issued by an appropriate entity check to see if the certificate indicates one or more of these items (this is the wording used to help sites evaluate if their calibration is accurate but is not required on the certificate itself to be considered valid)
bull Conforms to ISO 17025 bull Performed by an ILACMRA Signatory body accredited laboratory You can review this list of the ILAC MRA and Signatories (httpilacorgilac-mra-and-signatories)
bull Traceable to the standards maintained by NIST bull Meets specifications and testing requirements for the American Society for Testing and Materials (ASTM) Standard E2877 tolerance Class F (le 05 degC) or better
bull Includes reference to another acceptable accuracy validation method such as comparison to other traceable reference standards or tests at thermometric fixed points
Note CDC recommends that certifications be issued for the entire monitoring unit (detachable probe data logger etc) and not individual certificates for each component
IPI Advisor Manual | February 2017 Page 37
The 2017 MnVFC Site Visit Paperwork Chapter 4
For 45 E the provider is always responsible for supplying the current and valid certificate of calibration for a temperature monitoring device
bull Tip If the temperature monitoring device has a sticker on the back with the calibration date the site can usually call the company who calibrated the device and get a copy of the certificate if they donrsquot have one
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 46 4 Storage amp Handling Per Unit Probe Placement
Question 46 Is the probe properly placed in this section of the storage unit
Note to Reviewer ldquoProperlyrdquo means that the probe in a commercial or household unit is placed in a central area of the unitdirectly with the vaccines Probes should not be placed in the doors near or against the walls close to vents or on the floor of the unit The only allowable exemption related to this requirement is for providerswho have pharmaceutical storage units (built for vaccine storage) that have either (1) a built-intemperature monitoring device OR (2) a dedicated port for the probe that dictates the placement of theprobe
Answers (Choose one)
Yes No [X]
Review CDC Requirement
The probe must be placed in a central area of the section of the storage unit directly with the vaccines in order to properly measurevaccine temperature The probe should not be placed in the door near or against the walls close to vents or on the floor of theunit For pharmaceutical units with a built-in temperature monitoring device or a dedicated port for a probe that is not in thecenter of the section of the storage unit consult your Immunization Program for guidance on placement
Goal of this question Make sure the temperature monitoring device is in the best location to accurately measure the temperature of the vaccines stored in the unit
Helpful information bull The probe of the temperature monitoring device should be placed directly with the vaccines in the middle of the unit The ONLY allowable exception is for pharmaceutical storage units that have either a built-in thermometer or a dedicated port for the probe that indicates placement of the probe
bull Temperatures can vary within the unit especially household units bull Call MDH at 651-201-5522 if you have questions
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Guide (wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml)
Page 38 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 474 Storage amp Handling Per Unit Temperature Documentation
Question 47 Review the temperature documentation over the past three months for this section of the storage unit todetermine whether the provider has a process in place for properly documenting temperatures twice aday Answer the questions below
A Are there two temperature readings recorded for this section of the storage unit per day
Yes No [X]
B Is there a time date and name (or initials) recorded for each reading Yes No [X]
C What is the current temperature and minmax temperatures (if available) inthis section of the storage unit Use the reviewerrsquos thermometer if the providerrsquos temperature monitoringdevice does not have a current valid certificate of calibration testing or the probe is not properly placed in this section of the storage unit
Current Temperature Minimum Temperature Maximum Temperature Fahrenheit Celsius
D Based on your review of the providerrsquos recent temperature documentationincluding the current temperature is this section of the storage unitmaintaining appropriate temperatures
Yes No [X] Not enough information [X]
Review CDC Requirement
Vaccines must be stored under appropriate temperatures as described in the package inserts at all times Acceptable temperature ranges vary by vaccine type and the range is 36deg F and 46deg F (2deg C and 8deg C) and for frozen vaccines the range is -58deg F and +5deg F (shy50deg C and -15deg C) Exposure to temperatures outside of those included in the package inserts could affect vaccine viability andultimately could leave children unprotected against vaccine-preventable diseases In order to maintain awareness of storage unittemperatures and ensure that vaccines are being stored at appropriate temperatures at all times VFC providers are required to monitor and document temperatures for all vaccine storage units at least twice a day Temperature documentation must contain (1) at least two temperature readings per day (2) the time and date of each reading and (3) the name (or initials) of the personwho assessed and recorded the readings CDC also recommends that VFC providers record the minimum and maximumtemperatures of each unit once each workday (preferably in the morning)
Goal of this question Ensure the temperature is being monitored twice daily is within the required range and documented correctly Use your thermometer to check the temperature if the sitersquos temperature monitoring devicersquos probe is not properly placed or there is not a current certificate of calibration Place your thermometer in the unit at the beginning of the visit to allow sufficient time to reach an accurate temperature The purpose of using your thermometer is to ensure the vaccine is being stored at the proper temperature not to ldquovalidaterdquo their reading
Question 47 D is an assessment question based on information you have learned during your visit You might answer ldquonot enough informationrdquo if the unit is new and they donrsquot have at least three months of data or if the unit is only used as overflow and they are inconsistent with temperature monitoring Mark ldquoNordquo if you have reason to believe the storage unit is not maintaining temperatures properly
Helpful information bull All sites must document temperatures twice a day every day the site is open even if they have a data logger or continuous monitoring system
bull Sites can document the information electronically with some continuous monitoring systems as long as it can show what the current temp is the date time and initials of the person checking ndash this needs to be someone at the site ndash not checking remotely or centrally for a large site or system The site must be able to produce these records during their site visit Reviewing these files can be a challenge due to large volumes and lots of paper
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Temperature Logs on Managing Vaccine (wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml)
IPI Advisor Manual | February 2017 Page 39
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 484 Storage amp Handling Per Unit Temperature Excursions
Question 48 In the event that a temperature excursion(s) occurred in this unit within the last three months requestand review documentation of actions taken to determine whether the provider has a process for properlyaddressing excursions Answer the questions below
A Were vaccines in this unit exposed to out-of-range temperatures in the lastthree months (including today)
Yes No (If no skip to question 49)
B Did the provider quarantine and label vaccines as ldquoDo not userdquo Yes No [X]
C Did the provider place vaccine in a unit where it can be stored under properconditions if applicable
Yes No [X]
D Did the provider contact the Immunization Program to report theexcursion
Yes No [X]
E Was the manufacturer contacted for documentation supporting theusability of the vaccine
Yes No [X]
Review CDC Requirement
The provider must document all excursions and actions taken including the following (1) Quarantine and label vaccines as ldquoDO NOTUSErdquo (2) Place vaccines in a unit where they can be stored under proper conditions (3) Contact the Immunization Program to report an excursion and (4) Contact the vaccine manufacturer to obtain documentation supporting the usability of the vaccine
Goal of this question Address any out-of-range temperatures (temperature excursions) identified in reviewing the last three months of temperature logs or during the site visit If there were any out-of-range temperatures did the site respond appropriately to the situation This is a great opportunity to discuss what to do in the event of an excursion The Clinicians Storage and Handling Mishap Checklist is in the IPI Site Visit information folder and is a good review of the process
Helpful information bull Sites need to know that an excursion does not automatically mean that exposed vaccines are non-viable or unusable Exposed vaccines must be quarantined (marked ldquoDo Not Userdquo) and stored under proper conditions until they have received information from vaccine manufacturers regarding the viability of the vaccine
bull Sites must inform MDH when an excursion occurs
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Clinicians Storage and Handling Mishap Checklist (wwwhealthstatemnusdivsidepcimmunize ipivaxchklstpdf)
Page 40 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 49
Goal of this question Ensure proper placement of vaccines in the storage unit
Note These are all recommendations (best practices) not requirements
Helpful information bull Store vaccine in the middle of the compartment two to three inches away from the coils walls floor and cold air vent The temperature near the floor and walls of the unit differs from that in the middle of the compartment and the cold air vent can freeze refrigerated vaccines
4 Storage amp Handling Per Unit Vaccine Placement
Question 49 Look inside the unit to answer the questions below
A Are vaccines placed in the middle of the unit with space between vaccinesand the sideback of the unit to allow cold air to circulate
Yes No [O]
B Are vaccines stored in their original packages Yes No [O]
C Are there water bottles (for refrigerators) or frozen water bottles (forfreezers) in the unit
Yes No [O]
D Are vaccines store in the doors vegetable bins under or near cooling ventsor on the floor of the unit
Yes [O] No
E Is food being stored in the unit Yes [O] No
Review CDC Recommendation
Vaccines should be stored in their original manufacturer (or CDC centralized distributor) packaging They should be placed in the middle of the unit with space between the vaccines and the sideback of the unit to allow cold air to circulate Vaccines SHOULD NOT be stored in the doors vegetable bins or floor of the unit or under or near cooling vents and there should not be any food inthe unit Water bottles (for refrigerators) or frozen water bottles (for freezers) should be placed throughout each storage unit inorder to (1) stabilize or extend temperatures during a power outage and (2) to serve as physical blocks preventing the placementof vaccines in areas of the unit that are at higher risk for temperature excursions (such as in doors vegetable bins floor ornearunder cooling vents)
bull Vaccines should be kept in their original packaging to Protect them from light Help prevent medication errors by making labels easier to read Provide a moisture barrier that serves as insulation in case of an out-of-range temperature power outage door left open or mechanical failure Simplify managing vaccine inventory
bull Store water bottles in the doors on the floor and near the cold air vent in the refrigerator and frozen water bottles in the freezer to help maintain a stable temperature if there is a power failure and when the door is opened frequently Too many water bottles in the door can prevent the door from closing tightly Mark water bottles ldquoDo Not Drinkrdquo
bull Do not store vaccine in the door or drawers of the refrigerator or freezer Vegetable bins and crisper drawers should be removed from refrigerators or used to store other medical supplies or water bottles
bull If vaccine is stored in a household combination refrigeratorfreezer The top shelf should not be used for storing vaccine because the cold air vent blowing from the freezer will freeze vaccine located there If you must use the top shelf of this type of unit place water bottles underneath the cold air vent to prevent vaccine from being stored there It is recommended that only the refrigerator be used for vaccine storage and a separate stand-alone freezer be used to store frozen vaccine
bull Must not store food or beverages in the refrigerator or freezer because frequent opening of doors can lead to temperature variations that may affect vaccine viability There is also a risk of contaminating vaccines
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Guide (wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml) bull Vaccine Storage Tip Sheet on IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml)
IPI Advisor Manual | February 2017 Page 41
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 4104 Storage amp Handling Per Unit Disconnection from Power Source
Question 410 Ask the provider to demonstrate what measures are taken to ensure that vaccine storage units are notaccidentally physically disconnected from the power supply Which of the following describes the measure(s) taken on this unit
Note to Reviewer bull Large hospitals and healthcare systems may not have the ability to demonstrate labels on plugs or circuitbreakers In such cases verify that the practice has a comprehensive policy and standard operatingprocedures in place to prevent the vaccine storage unit from being physically disconnected from thepower supply
bull While back-up generators may ensure power to the overall facility this question ONLY addresses thevaccine storage unit being accidentally disconnected from the power source either through the plug orthe circuit breaker
Answers A ldquoDo not disconnectrdquo labels on the plug (Choose all that B ldquoWarningrdquo label on the circuit breaker box
apply) C Hard-wired (ie built-in) and has a ldquoDo not disconnectrdquo label on thecircuit breaker box D Hospital or large health care system with a comprehensive written policyand standard operating procedures detailing measures taken to preventvaccine storage units from being accidentally disconnected from the powersupply E No acceptable measures for preventing accidental disconnection frompower supply [X]
[X] The response is non-compliant if only A only B or E is selected
Review CDC Requirement
VFC providers must take steps to protect the power source for all vaccine storage equipment by means of having clear warninglabels on both the plug and the circuit breaker associated with all vaccine storage units Large hospitals and healthcare systems canmeet this requirement by demonstrating that they have comprehensive policies and standard operating procedures to preventvaccine storage units from being physically disconnected from the power supply
Goal of this question Decrease the chance that a vaccine storage unit will be accidently unplugged or power will be turned off while vaccine is in the unit This question addresses only what measures the site has taken to ensure the storage unit is not physically disconnected from its power source
If the site uses labels on the plugs and circuit breakers perform a visual inspection to assess whether the way the stickers are positioned make it clear and obvious to anyone that these units are not to be disconnected
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Do Not Unplug and Warning stickers are included in the folder or available to order on the For
Professionals Order Form (wwwhealthstatemnusdivsidepcimmunizeordermathtml)
Note Once you have completed the 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet for each unit return to the questionnaire to complete sections 5 and 6
Page 42 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
- -
Section 5 Storage amp Handling Site-Wide Question 51
5 Storage amp Handling Site Wide Discussion of Cost amp Quantity of Vaccine
Question 51 Have a discussion with the provider about the cost and quantity of VFC vaccines they are responsible for annually Address the points listed in the note to reviewer below
Note to Reviewer bull Vaccine Shipped (Required) Share the cost of VFC vaccines shipped to the provider in the last calendaryear to make sure the provider understands the contribution made by the VFC Program to their practiceFor new providers who do not have ldquocalendar yearrdquo data share either the actual cost of their currentinventory or use the cost of 10 VFC doses of each of the ACIP-recommended vaccines (approximately $7000) to help estimate their annual cost
bull Storage amp Handling (Required) Make sure the provider understands the cost of vaccines for which they are responsible when they make decisions about purchasing recommended vaccine storage and temperature monitoring equipment
Answer I have discussed with the provider the cost and quantity of vaccines ordered in the previous calendar year
Goal of this question Inform sites of the quantity and value of vaccines that they receive as part of the MnVFC program Providers often donrsquot realize the value of the vaccine in their unit This information is included on your clinic list and on the one page site-specific information
Helpful information bull This discussion must occur and the box on the questionnaire must be checked bull If there isnrsquot actual vaccine value information available tell the site that one vaccine order that includes a box of each of the ACIP recommended vaccines costs approximately $7000
bull MDH may not have specific information for individual sites if they receive vaccine from a central warehouse or pharmacy For those sites MDH will give you numbers for the whole system so you can discuss system wide data as appropriate If individual site information is also included it is usually just varicella-containing vaccines that must be shipped directly to the site
Question 52
5 Storage amp Handling Site Wide Dorm Style Units
Question 52 Determine whether the provider has any dorm-style units on site and answer the questions below
Note to Reviewer A dormitory-style refrigerator is a unit that has both refrigerator and freezer compartments behind a singleexterior door Dorm-style units also have an evaporator plate (cooling coil) which is usually located insidean icemaker compartment (freezer) within the refrigerator
A Does the provider have any dorm-style units that are used at any time tostore vaccines
Yes [X] No (Skip to question 53)
B Does the provider have sufficient space in existing compliant vaccinestorage units to store all vaccines without use of the dorm-style unit at any time
Yes No [X]
Review CDC Requirement
Dorm- and bar-style units are prohibited for vaccine storage Vaccines stored in dorm-style units are considered non-viable and must be returned to the centralized distributor CDC recommends the following vaccine storage unit types (in order of preference)pharmaceutical grade stand-alone or combination units (preferred) householdcommercial stand-alone unitshouseholdcommercial combination units using the refrigerator section only
Goal of this question Ensure no vaccine is stored in dorm-style units even for short periods of time Encourage them to label any units ldquoNo Vaccine Storage Allowedrdquo Vaccine stored in these units is considered non-viable If a site is using a dorm-style unit call the MnVFC program (651-201-5522)
Resource Section 8 in the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 43
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 535 Storage amp Handling Site Wide Storage Unit Space Availability
Question 53 Does the provider have sufficient room across storage units to store current stock as well as anyadditional stock acquired during peak season without overcrowding
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have sufficient storage space to accommodate vaccine stock at the busiest time of year without overcrowding
Goal of this question Ensure that sites have sufficient space in their units to maintain vaccines at the busiest time of year Overcrowding of vaccine limits air circulation and affects the unitrsquos ability to maintain stable temperatures
Helpful information bull Look for signs of overcrowding such as vaccines that are pushed up against the wall bins that are overflowing or storage units that are full during non-peak seasons
Discuss immediate actions if the unit is overcrowded Move some of their vaccines order less vaccine more frequently (once per month preferably) andor purchase another storage unit for overflow
Resource bull Section 8 MnVFC Policy and Procedure Manual
Page 44 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 545 Storage amp Handling Site Wide Expired Vaccines
Question 54 Look in each unit Are there expired vaccines in any of the vaccine storage units at this site
Answers (Choose one)
Yes [X] No
Review CDC Requirement
Vaccines should be rotated weekly and when a new shipment comes in so that longer-dated vaccines are stored behind shorter-dated vaccines If vaccines expire they can no longer be stored in the same storage unit with viable vaccines They must be placedin a container or bag clearly labeled ldquoDo not userdquo and separated from viable vaccines to prevent inadvertent use Expired vaccinemust be returned to the centralized distributor within six months of expiration
Goal of this question Ensure there is no expired vaccine in any storage unit
Helpful information bull Sites can prevent their stock from expiring by rotating vaccines every week andor when a new shipment arrives Longer-dated vaccines are stored towards the back of the unit and shorter-dated vaccines are up front
bull Pay attention to vaccines that expire within the next three months Consider transferring vaccine that will expire soon to another MnVFC-enrolled site that will use the vaccine preferably a site close by It is the transferring sitersquos responsibility to arrange the transfer of the vaccine Be sure to complete the MDH Vaccine Transfer Record form and send it to MDH If they are having difficulty finding a location to accept vaccine contact MDH
bull This is a great opportunity to educate sites about the MDH Nonviable Vaccine Form and the process for returning vaccine The VFC program does get some credit for taxes and fees on vaccine that is returned to the distribution center
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MDH Nonviable Vaccine Form and MDH Vaccine Transfer Record on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfcformshtml)
IPI Advisor Manual | February 2017 Page 45
The 2017 MnVFC Site Visit Paperwork Chapter 4
- -
-
Question 555 Storage amp Handling Site Wide Back up Thermometer
Question 55 Does the provider have a readily available back-up thermometer with a current and valid certificate ofcalibration testing
Note to Reviewer ldquoReadily availablerdquo means that the thermometer is available to perform twice-a-day monitoring for a unit asrequired CDC recommends that the back-up thermometer be maintained on site
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have a readily available back-up thermometer with a current and valid certificate of calibration testing Toprevent the certificates of calibration testing of the primary and back-up thermometers from expiring at the same time the date of calibration testing (or issue date) of the back-up thermometer should be different from the date of calibration testing (or issue date) of the primary thermometer As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meetsVFC program requirements
Goal of this question Ensure sites have one calibrated back-up thermometer onsite that is readily available in the event that the temperature monitoring device in unit fails transportation of vaccine is needed or there are other unexpected circumstances
Helpful information bull As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meets VFC Program requirements
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 56 5 Storage amp Handling Site Wide Preparation of Vaccine
Question 56 When does this provider prepare vaccine for administration to the patient
Note to Reviewer For mass vaccination clinics if one type of vaccine is offered providers may pre-draw up to 10 doses Ifusing pre-filled syringes pre-drawing also means activating the syringe by removing the needle guard orattaching a needle
Answers (Choose all that
apply)
Prepare dose immediately before administration Pre-draw doses for upcoming patients (in a regular clinicpractice) [O] Pre-draw up to 10 doses (in a mass-vaccination clinic) Pre-draw more than 10 doses (in a mass-vaccination clinic) [O] Other [O]
Review CDC Recommendation
CDC recommends preparing vaccines immediately prior to administration in order to assure viability of vaccine and prevent vaccinewastage Vaccines that are not administered immediately are at risk of exposure to temperatures outside of the required rangewhich can affect vaccine viability and ultimately can leave children unprotected against vaccine-preventable diseases
Goal of this question Discuss proper timing and preparation of vaccine(s) for administration These are recommendations not requirements
Helpful information bull Educate staff on the importance of preparing vaccine immediately before administration Pre-drawing of vaccines may lead to concerns related to vaccine viability potency sterility and wastage
Page 46 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 6 Inventory Question 61
6 Inventory Inventory Comparison
Question 61 Visually inspect storage units to determine if existing supply of vaccines proportionately mirrorspopulations served Choose the most accurate statement below
Note to Reviewer bull CDC recommends that providers maintain a four-week supply of inventory bull For this question do not take into account vaccine types that the provider does not order Here simply
make sure that overall the vaccines in the providerrsquos storage units are available in sufficient amounts toserve their patient population
Answers (Choose one)
The current vaccine inventory proportionately reflects the populations identified Only public stock is insufficient [X] Only private stock is insufficient [X] Both public and private stock are insufficient [X] Site uses the replacement method but does not appear to have enough vaccine for their population [X] Other [X]
Review CDC Requirement
VFC providers must order and stock routine vaccines in accordance with their patient population in order to prevent missedvaccination opportunities Having sufficient amounts of all stocks prevents the inadvertent use of VFC vaccines for non-VFC-eligiblepatients and vice versa
Goal of this question Assess whether the site is ordering appropriate quantities of vaccine for the population they serve at their site
Helpful information bull If the site sees 30 percent private-pay patients and 70 percent VFC the stock in their storage units should reflect that proportion If you donrsquot know you can ask the site about their population
bull This is meant to be a general assessment so in a big site if they have only a small amount of vaccine that may indicate an issue with vaccine management
bull CDC recommends smaller more frequent orders (ie monthly) rather than large orders to minimize the amount of vaccine loss if an incident occurs during shipment or in the storage unit Sites should not order more frequently than once a month
bull Sites using the replacement method will only have one stock but it should appear to be large enough for their population
bull Only assess the vaccine types that the site currently stocks in their unit We know there are sites that do not offer all ACIP-recommended vaccines for various reasons That issue will be addressed in question 62
IPI Advisor Manual | February 2017 Page 47
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 626 Inventory ACIP Recommended Vaccines
Question 62 Review providerrsquos current inventory to answer the questions below
A Does the provider offer all routine ACIP-recommendedvaccines for their patient population
Yes (Skip to question C) No [X] Offers all except varicella because direct ship ofvaccine is unavailable from manufacturer
B Which routine vaccines are NOT being offered DTaP Hepatitis A Hepatitis B HIB HPV Influenza Meningococcal
MMR Pneumococcal Polio Rotavirus TdapTd Varicella
C According to Immunization Program Policy does theprovider make accessible all non-routine ACIP-recommended vaccines for those VFC patients whomeet the criteria for receiving them
Yes (Skip to question 63) No [X]
D Which non-routine vaccines are NOT being offered Pneumococcal polysaccharide vaccine (PPSV23) Meningococcal Group B (MenB) Other
Review CDC Requirement
VFC providers agree to comply with immunization schedules dosages and contraindications that are established by the Advisory Committee on Immunization Practices (ACIP) for the vaccines identified and agreed upon in the Provider Agreement UNLESS bull In the VFC providers medical judgment and in accordance with accepted medical practice the VFC provider deems such
compliance to be medically inappropriate for the child bull The particular requirements contradict state law including laws pertaining to religious and other exemptions The VFC program entitles children to the following vaccines DTaP Hepatitis A Hepatitis B HIB HPV Influenza MeningococcalMMR Pneumococcal Polio Rotavirus TdapTd and Varicella VFC providers are also required to ensure that VFC-eligible children have access to non-routine vaccines as needed
Goal of this question Assess if the site is offering all the ACIP-recommended vaccines for the population they serve and these vaccines are in stock on the day of the visit It is important that every MnVFC-eligible child that comes to a providerrsquos office for an immunization is vaccinated
Helpful information bull The Advisory Committee on Immunization Practices (ACIP) is a group of medical and public health experts that develops recommendations on how to use vaccines to control diseases in the United States
bull Specialty providers are not required to offer all routine vaccines but should provide the vaccines appropriate for their population
bull If the site does not offer all routine ACIP-recommended vaccines appropriate for their population check the ldquoNordquo box in Part A then check the appropriate box(es) in Part B for any vaccines not offered Please contact MDH as this situation offers us the opportunity to provide education to the site
bull For non-routine vaccines they must either be in stock or the site must have an alternative protocol in the routine management plan that ensures these children have access when applicable
Resources bull IAC Diseases and Vaccines (wwwimmunizeorgvaccines) bull CDC Advisory Committee on Immunization Practices (ACIP) (wwwcdcgovvaccinesacipindexhtml)
Page 48 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 636 Inventory Separation of Stock
Question 63 Observe how the provider differentiates stock in each storage unit to answer the questions below
A Is it clear which vaccines belong to public stock andwhich belong to private stock
Yes No [X] Not applicable replacement site
B Is it clear which vaccines belong to VFC stock andwhich belong to UUAV stock
Yes No [X] Not applicable replacement site Not applicable not UUAV-enrolled site
Review CDC Requirement
In order to ensure that VFC vaccines are only administered to VFC-eligible children VFC providers that serve both VFC and non-VFCshyeligible children must maintain their vaccine inventories in such a way that they can clearly differentiate public stock from privatestock as well as VFC from other public stock
Goal of this question Assess whether the site can distinguish between MnVFC vaccine and private vaccine If they participate in the Uninsured and Underinsured Adult Vaccine (UUAV) program they should also be able to distinguish between MnVFC stock and UUAV stock Some sites use labels bins boxes etc to differentiate their stock If it is not clear how the site differentiates their stock discuss vaccine management with the staff For follow-up call MDH to discuss doing a follow-up site visit
Sites using the replacement method will not have separate stocksmdashthis is an approved alternative method for keeping track of vaccine
Resource bull Section 10 of the MnVFC Policy and Procedure Manual
IPI Advisor Manual | February 2017 Page 49
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
MnVFC Site Visit Storage and Handling Per Unit Answer Sheet 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet MnVFC PIN ___________________
Question number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
Temperature Monitoring Device Questions Questions 43 47 must be answered separately for the freezer and refrigerator if the unit is a combo Be sure to document responses in the appropriate column
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
All the questions on the Site Visit Storage amp Handling Per Unit Answer Sheet have been discussed previously in section 4 of this manual Use this sheet to record information about all the units at the site visit You will need one sheet for each unit If it is a combination unit (either pharmaceutical or household) you can record both sections on one sheet If they have stand-alone units use one sheet for each unit Do not enter the answers to the questions in section 4 of the questionnaire
If you need more information about any of the questions refer back to the main questionnairemdashthe complete question additional guidance including notes to the reviewer and the CDC requirements are there Also if the site is not meeting the requirement you will go back to the questionnaire to complete the ldquoActions if Non-compliantrdquo section including the root cause analysis and follow-up sections
When you have completed the assessment of all the storage units remember to go back to the questionnaire to complete sections 5 and 6
Page 50 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
ndash
ndash
MnVFC Provider Follow-up PlanThe goal of the Provider Follow-up Plan is to communicate with the site all of the VFC requirements any unmet requirements found during your site visit and the timeline for completing the required action The left hand column is a box to check for ldquoUnmetrdquo requirements
Helpful information bull The form can be used to review what the site is doing well and what they need to work on
bull For requirements that have specific documentation that needs to be sent to you use the notes section
2017 MnVFC Provider Follow-up Plan Site _______________________________________________ MnVFC PIN ____________ Date of Visit ___________
Thank you for participating in this MnVFC compliance site visit Please review this visit summary including follow-up actions and timelines for completion Unmet MnVFC requirements and recommendations have a checked box next to them The goal of this plan is to support you with successfully implementing the program and improving access to vaccines for VFC-eligible children
Unmet Question VFC Requirements Section 1 Changes to Key Staff
Q12 Change in the Medical Director Immunization Manager Vaccine Coordinator or back-upKey Staff must be communicated to the immunization program by emailing healthmnvfcstatemnus Changes Notes
Q12 Key staff must complete the annual training on VFC program requirements and print theAnnual Training certificate of completion Documentation Required Action
Staff that have not completed the MnVFC online training must complete it and send acopy of the certificate to the reviewer Training can be found on the MnVFC website (wwwhealthstatemnusvfc) Due date 1 month
Notes
Unmet Question VFC Requirements Section 2 Eligibility
Q21 Provider staff must possess a working knowledge of all VFC eligibility criteria and use thoseVFC Eligibility criteria to screen children prior to administering VFC vaccines
Categories Notes
bull This form provides documentation needed for follow-up actions when you send your thank you email
The second to last page of the Provider Follow-up Plan has a summary of the MnVFC program recommendations These are to remind the site about best practices they may want to improve upon even though they are not yet requirements of the program For example you could discuss the recommendation about storage units if they currently have a combination household unit and are using both sections
The last section is for your signature and the person you met with In most sites it will be the immunization manager or vaccine coordinator who signs the form unless the medical director attended the site visit You keep the original copy and the site will need to keep a copy for themselves
To be completed by the site visit reviewer
I acknowledge that a VFC site visit was performed on __________________ (visit date) The follow-up plan which includes a list of all current VFC program requirements and recommendations assessed during the visit and any required follow-up actions was provided at the end of the visit
Site visit reviewer
Phone
Reviewer Signature Date
To be completed by the provider
I acknowledge that our practice took part in the VFC site visit noted above I understand the findings of the visit and any required actions that must be taken by our office in order to meet VFC program requirements
Medical Director (or designee) Name Title
Medical Director (or designee) Signature Date
IPI Advisor Manual | February 2017 Page 51
The 2017 MnVFC Site Visit Paperwork Chapter 4
After the Site Visit Send a thank you email highlighting the unmet requirements documents you need from the site to resolve the issue(s) and the date you need them Make sure to include the link to the Site Visit Survey (httpssurveyvovicicomseashxs=56206EE334CE0B14)
Please refer to Chapter 3 for more information about future follow-up required after the visit including forms and documentation
Resource bull Sample Thank You letter on IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml)
Chapter 5
IPI Advisor Resource List MnVFC Program 651-201-5522
MnVFC wwwhealthstatemnusvfc
bull Separate Stock and Replacement Method Policies and Procedures Manuals bull Online trainings bull MnVFC Announcements sign up to receive them via email bull Ordering MDH vaccine bull MnVFC forms Screening forms Reporting forms Others MDH Nonviable Vaccine Form MDH Vaccine Transfer Record and Vaccine Borrowing Report
bull MnVFC promotional materials bull Immunization Billing Guidance for MnVFC and Immunization Billing Guidance for MnVFC Replacement Sites Immunization Practices Improvement Program (IPI) wwwhealthstatemnusdivsidepcimmunizeipi
bull IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml) bull IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml) IPI Resource Folder Contents (wwwhealthstatemnusdivsidepcimmunizeipiipifolderpdf)
Minnesota Immunization Information Connection (MIIC) wwwhealthstatemnusmiic
bull MIIC regions and regional coordinators
Clinical Practice MDH Immunization Program wwwhealthstatemnusimmunize
Got Your Shots News wwwhealthstatemnusdivsidepcnewslettersgys
MDH Immunization Information for Health Care Providers wwwhealthstatemnusdivsidepcimmunizehcp
bull Got Your Shots A Providers Guide to Immunization in Minnesota bull Vaccine protocols bull Forms for tracking patient immunizations bull Immunization schedules for Health Care Providers Immunization Action Coalition (IAC) wwwimmunizeorg
bull Ask the Experts bull VISs (Vaccine Information Statements and translations) bull Administration screening questions bull Medical management of vaccine reactions bull Order form for Californiarsquos Immunization Technique DVD Best Practices with Infants Children and Adults
Page 52 IPI Advisor Manual| February 2017
IPI Advisor Resource List Chapter 5
CDC ldquoPink Bookrdquo wwwcdcgovvaccinespubspinkbookindexhtml
CDC Advisory Committee on Immunization Practices (ACIP) wwwcdcgovvaccinesacip
CDC Vaccines and Immunizations wwwcdcgovvaccines
VAERS reporting httpvaershhsgovindex
Storage and Handling Got Your Shots Providers Guide ndash Managing Vaccine wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml
MnVFC Guide to Temperature Monitoring Devices wwwhealthstatemnusvfc
MDH Clinicianrsquos Vaccine Mishap Checklist wwwhealthstatemnusdivsidepcimmunizeipivaxchklstpdf
MDH Vaccine Storage Guide wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml
CDC Vaccine Storage and Handling Toolkit wwwcdcgovvaccinesrecsstoragetoolkit
You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Vaccine manufacturer phone numbers wwwcdcgovvaccinespubspinkbookdownloadsappendicesFcontact-info-manufactpdf
IAC Checklist for Safe Vaccine Handling and Storage wwwimmunizeorgcatgdp3035pdf
IAC Donrsquot Be Guilty of These Errors in Vaccine Storage and Handling wwwimmunizeorgcatgdp3036pdf
Additional Resources Print materials from MDH ndash order forms wwwhealthstatemnusdivsidepcimmunizeordermathtml
Vaccine Education Center ndash Childrenrsquos Hospital of Philadelphia wwwchopeduservicevaccine-education-centerhomehtml
California Department of Public Health ndash Interactive training on vaccine administration and storage and handling handout on transporting vaccine and how to package wwwezizorg
IPI Advisor Manual | February 2017 Page 53
IPI Advisor Resource List Chapter 5
CDC vaccine price list wwwcdcgovvaccinesprogramsvfcawardeesvaccine-managementprice-listindexhtml
Vaccine Information Statements (VIS) wwwcdcgovvaccineshcpvisindexhtml
CEU Opportunities CDC Immunization Education and Training wwwcdcgovvaccinesedindexhtml
Immunization You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Page 54 IPI Advisor Manual| February 2017
- Introduction
-
- Welcome to the Immunization Practice Improvement (IPI) Program
- Contact Information
-
- Chapter 1
- Requirements to Participate in the MnVFC Program
- Vaccines for Children Program
- Chapter 2
- Reimbursement for MnVFC Visits
- Types of Visits
- Your MnVFC Clinical CoordinatorPlanner
- New IPI Advisor Training Requirements
- Your Role as an IPI Advisor
- Reasons MDH Would Do All or Part of a Visit
- Chapter 3
- Future follow-up
- Conducting the Visit
- Preparing for the Visit
- Information for the Visit
- Site Visit Checklist
- Scheduling the Visit
- Chapter 4
- After the Site Visit
- MnVFC Provider Follow-up Plan
- MnVFC Site Visit Storage and Handling Per Unit Answer Sheet
- Section 6 Inventory
- Section 5 Storage amp Handling Site-Wide
- Section 4 Storage amp Handling Per Unit
- Section 3 Documentation
- Section 2 Eligibility
- Section 1 Provider Details
- The Site Visit Reviewer Legend
- MnVFC Site Visit Questionnaire
- Required Paperwork for Site Visits
- Chapter 5
-
Page 34 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 444 Storage amp Handling Per Unit CDC Recommended Temperature Monitoring Device
Question 44 Assess the temperature monitoring device in this section of the storage unit to answer the questionsbelow
A Is the temperature monitoring device a continuous monitoring and recordingdevice (eg data logger)
Yes No [O] (Skip D)
B Does the temperature monitoring device have a probe in buffered material Yes No [O]
C Does the temperature monitoring device have a digital display that can beeasily read from the outside of this unit
Yes No [O]
D Is data downloaded and reviewed routinely Yes No [O]
Review CDC Recommendation
As of Jan 1 2018 all VFC providers must use continuous temperature monitoring devices (eg data loggers) to monitor vaccinesthat will be administered to VFC-eligible children Routine review and accessibility of temperature data is critical for determining whether vaccine has been properly stored and for assessing usability of vaccine that was involved in a temperature excursion Tomeet VFC Program requirements the device must also be equipped with bull A temperature probe bull An active temperature display that can be easily read from the outside of the unit bull The capacity for continuous monitoring and recording capabilities where the data can be routinely downloaded
The following are additional recommended features for these devices bull Alarm for out-of-range temperatures bull Current minimum and maximum temperatures display bull Low battery indicator bull Accuracy of +- 1degF (05degC) bull Memory storage of at least 4000 readings bull User programmable logging interval (or reading rate) recommended at a maximum time interval of every 30 minutes bull Use of a probe that best reflects the temperature of the vaccine (such as a buffered probe)
Goal of this question Assess the temperature monitoring device in the storage unit Note that these are all recommendations not requirements at this time
This is a great teaching opportunity for sites who do not currently have a continuous temperature monitoring device Beginning Jan 1 2018 all units that store MnVFC vaccine will be required to have a continuous temperature monitoring device (ie a data logger or a continuous temperature monitoring system) Unlike a minmax thermometer a continuous temperature monitoring device provides detailed information on all temperatures recorded at pre-set intervals For excursions it can provide information on when a temperature went out-of-range for how long and what the temperatures were This is essential information that vaccine manufacturers need to know to assess the viability of the vaccine following an excursion
Helpful information bull Sites are required to monitor and record temperatures twice daily however temperature excursions can easily occur in the 12 hours or longer between readings Continuous temperature monitoring can help manufacturers determine vaccine viability
bull Continue to encourage sites to document and evaluate minimum and maximum temperatures the storage unit reached since the last reading and respond appropriately to out-of-range temperatures
IPI Advisor Manual | February 2017 Page 35
The 2017 MnVFC Site Visit Paperwork Chapter 4
bull It is recommended that sites download and review data weekly Discuss with sites that reviewing temperature monitoring device data also includes responding appropriately if they identify out-of-range temps
bull There is sometimes confusion about the difference between a data logger and a continuous temperature monitoring system Here are some differences
Data Loggers Continuous Monitoring Systems Have an external display similar to thermometers May or may not have an external display Have a detachable probe Probe is usually attached to transmitter Need to be plugged into the computer or cradle to download information on a regular schedule
Wirelessly sends data to computer system
Create a file of data that needs to be saved on the computer
Data is stored within the system not a separate file
Doesnrsquot allow documentation of twice a day temperature checks in the file
May allow documentation of twice a day temperature checks within the system
More about the 2018 requirement for a continuous temperature monitoring device
Required Features bull The continuous temperature monitoring device must have Continuous monitoring and recording capabilities to track and record temperatures over time The capacity to routinely download temperature data to a computer (recommended at least weekly) or wirelessly transmit data Detachable probe in a bottle filled with a thermal buffer (eg bio-safe glycol) if the data logger needs to be detached in order to download data Active temperature display
Recommended Features bull MnVFC recommends continuous temperature monitoring devices with Alarm for out-of-range temperatures Accuracy within +-1degF (+- 05degC) Low battery indicator Display of current minimum and maximum temperatures Memory storage of at least 4000 readings User programmable logging intervals (eg the user can set how often the device records the temperature)
Note that these are all currently recommendations not requirements yet
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Page 36 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 45
Goal of this question Ensure the temperature monitoring device is properly calibrated The certificate of calibration testing means that the device has been tested and it is accurately measuring temperatures within established testing limits The certificate of calibration ensures that the device meets all the required components
Helpful information bull The provider is always responsible for having a current certificate of calibration (or copy) on-site
bull To be considered ldquovalidrdquo a certificate of calibration must contain these required elements Modeldevice name or number Serial number
4 Storage amp Handling Per Unit Certificate of Calibration Testing
Review CDC Requirement
Certificates of calibration testing provide confidence that the temperature monitoring device is measuring temperaturesaccurately All units storing VFC vaccines must have a calibrated temperature monitoring device with a current and valid certificateof calibration testing All certificates must contain modeldevice name or number serial number date of calibration testing (report or issue date) and Instrument Passed testingInstrument in Tolerance (Recommended uncertainty = +-05ordm C (+-1ordm F))
Question 45
Note to Reviewer
A
B
C
D
E
Review the certificate of calibration testing for the temperature monitoring device in this section of the storage unit and answer the questions below
bull How to determine certificate of calibration testing expiration date 1) Identify the certificate issuecalibration date 2) Apply the Immunization Program-required frequency for calibration testing Example If the
issuecalibration date is 12312013 and Immunization Program policy requires testing every twoyears the expiration date is 12312015
bull Certificates must include all of the below bull ModelDevice Name or Number bull Serial Number bull Date of Calibration Testing (Report or Issue Date) bull Instrument Passed testing (Instrument in Tolerance)
Is there a certificate of calibration testing for the temperature monitoring Yes device in this section of the storage unit No [X]
What is the date of calibration for the temperature monitoring device in this section of the storage unit
What is the certificatersquos date of expiration based on ImmunizationProgram policy (See note to reviewer to determine expiration date) [X] Follow-up is required if
certificate is expired
Does the certificate contain all the necessary items listed in the Note to Yes Reviewer No [X]
Who is responsible for supplying the current and valid certificate of Provider calibration for this temperature monitoring device
Date of calibration testing (report or issue date) Note If there is no expiration date the certificate expires 2 years from the date of calibration Whether the instrument passed or failed testing (or instrument in tolerancenot in tolerance)
bull Recommended element Documented uncertainty of +- 1degF [05degC]
If these elements are present the certificate is considered valid If the certificate contains information about the recommended element or the entity that issued the certificate that is helpful but not required
To determine if a certificate of calibration testing was issued by an appropriate entity check to see if the certificate indicates one or more of these items (this is the wording used to help sites evaluate if their calibration is accurate but is not required on the certificate itself to be considered valid)
bull Conforms to ISO 17025 bull Performed by an ILACMRA Signatory body accredited laboratory You can review this list of the ILAC MRA and Signatories (httpilacorgilac-mra-and-signatories)
bull Traceable to the standards maintained by NIST bull Meets specifications and testing requirements for the American Society for Testing and Materials (ASTM) Standard E2877 tolerance Class F (le 05 degC) or better
bull Includes reference to another acceptable accuracy validation method such as comparison to other traceable reference standards or tests at thermometric fixed points
Note CDC recommends that certifications be issued for the entire monitoring unit (detachable probe data logger etc) and not individual certificates for each component
IPI Advisor Manual | February 2017 Page 37
The 2017 MnVFC Site Visit Paperwork Chapter 4
For 45 E the provider is always responsible for supplying the current and valid certificate of calibration for a temperature monitoring device
bull Tip If the temperature monitoring device has a sticker on the back with the calibration date the site can usually call the company who calibrated the device and get a copy of the certificate if they donrsquot have one
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 46 4 Storage amp Handling Per Unit Probe Placement
Question 46 Is the probe properly placed in this section of the storage unit
Note to Reviewer ldquoProperlyrdquo means that the probe in a commercial or household unit is placed in a central area of the unitdirectly with the vaccines Probes should not be placed in the doors near or against the walls close to vents or on the floor of the unit The only allowable exemption related to this requirement is for providerswho have pharmaceutical storage units (built for vaccine storage) that have either (1) a built-intemperature monitoring device OR (2) a dedicated port for the probe that dictates the placement of theprobe
Answers (Choose one)
Yes No [X]
Review CDC Requirement
The probe must be placed in a central area of the section of the storage unit directly with the vaccines in order to properly measurevaccine temperature The probe should not be placed in the door near or against the walls close to vents or on the floor of theunit For pharmaceutical units with a built-in temperature monitoring device or a dedicated port for a probe that is not in thecenter of the section of the storage unit consult your Immunization Program for guidance on placement
Goal of this question Make sure the temperature monitoring device is in the best location to accurately measure the temperature of the vaccines stored in the unit
Helpful information bull The probe of the temperature monitoring device should be placed directly with the vaccines in the middle of the unit The ONLY allowable exception is for pharmaceutical storage units that have either a built-in thermometer or a dedicated port for the probe that indicates placement of the probe
bull Temperatures can vary within the unit especially household units bull Call MDH at 651-201-5522 if you have questions
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Guide (wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml)
Page 38 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 474 Storage amp Handling Per Unit Temperature Documentation
Question 47 Review the temperature documentation over the past three months for this section of the storage unit todetermine whether the provider has a process in place for properly documenting temperatures twice aday Answer the questions below
A Are there two temperature readings recorded for this section of the storage unit per day
Yes No [X]
B Is there a time date and name (or initials) recorded for each reading Yes No [X]
C What is the current temperature and minmax temperatures (if available) inthis section of the storage unit Use the reviewerrsquos thermometer if the providerrsquos temperature monitoringdevice does not have a current valid certificate of calibration testing or the probe is not properly placed in this section of the storage unit
Current Temperature Minimum Temperature Maximum Temperature Fahrenheit Celsius
D Based on your review of the providerrsquos recent temperature documentationincluding the current temperature is this section of the storage unitmaintaining appropriate temperatures
Yes No [X] Not enough information [X]
Review CDC Requirement
Vaccines must be stored under appropriate temperatures as described in the package inserts at all times Acceptable temperature ranges vary by vaccine type and the range is 36deg F and 46deg F (2deg C and 8deg C) and for frozen vaccines the range is -58deg F and +5deg F (shy50deg C and -15deg C) Exposure to temperatures outside of those included in the package inserts could affect vaccine viability andultimately could leave children unprotected against vaccine-preventable diseases In order to maintain awareness of storage unittemperatures and ensure that vaccines are being stored at appropriate temperatures at all times VFC providers are required to monitor and document temperatures for all vaccine storage units at least twice a day Temperature documentation must contain (1) at least two temperature readings per day (2) the time and date of each reading and (3) the name (or initials) of the personwho assessed and recorded the readings CDC also recommends that VFC providers record the minimum and maximumtemperatures of each unit once each workday (preferably in the morning)
Goal of this question Ensure the temperature is being monitored twice daily is within the required range and documented correctly Use your thermometer to check the temperature if the sitersquos temperature monitoring devicersquos probe is not properly placed or there is not a current certificate of calibration Place your thermometer in the unit at the beginning of the visit to allow sufficient time to reach an accurate temperature The purpose of using your thermometer is to ensure the vaccine is being stored at the proper temperature not to ldquovalidaterdquo their reading
Question 47 D is an assessment question based on information you have learned during your visit You might answer ldquonot enough informationrdquo if the unit is new and they donrsquot have at least three months of data or if the unit is only used as overflow and they are inconsistent with temperature monitoring Mark ldquoNordquo if you have reason to believe the storage unit is not maintaining temperatures properly
Helpful information bull All sites must document temperatures twice a day every day the site is open even if they have a data logger or continuous monitoring system
bull Sites can document the information electronically with some continuous monitoring systems as long as it can show what the current temp is the date time and initials of the person checking ndash this needs to be someone at the site ndash not checking remotely or centrally for a large site or system The site must be able to produce these records during their site visit Reviewing these files can be a challenge due to large volumes and lots of paper
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Temperature Logs on Managing Vaccine (wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml)
IPI Advisor Manual | February 2017 Page 39
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 484 Storage amp Handling Per Unit Temperature Excursions
Question 48 In the event that a temperature excursion(s) occurred in this unit within the last three months requestand review documentation of actions taken to determine whether the provider has a process for properlyaddressing excursions Answer the questions below
A Were vaccines in this unit exposed to out-of-range temperatures in the lastthree months (including today)
Yes No (If no skip to question 49)
B Did the provider quarantine and label vaccines as ldquoDo not userdquo Yes No [X]
C Did the provider place vaccine in a unit where it can be stored under properconditions if applicable
Yes No [X]
D Did the provider contact the Immunization Program to report theexcursion
Yes No [X]
E Was the manufacturer contacted for documentation supporting theusability of the vaccine
Yes No [X]
Review CDC Requirement
The provider must document all excursions and actions taken including the following (1) Quarantine and label vaccines as ldquoDO NOTUSErdquo (2) Place vaccines in a unit where they can be stored under proper conditions (3) Contact the Immunization Program to report an excursion and (4) Contact the vaccine manufacturer to obtain documentation supporting the usability of the vaccine
Goal of this question Address any out-of-range temperatures (temperature excursions) identified in reviewing the last three months of temperature logs or during the site visit If there were any out-of-range temperatures did the site respond appropriately to the situation This is a great opportunity to discuss what to do in the event of an excursion The Clinicians Storage and Handling Mishap Checklist is in the IPI Site Visit information folder and is a good review of the process
Helpful information bull Sites need to know that an excursion does not automatically mean that exposed vaccines are non-viable or unusable Exposed vaccines must be quarantined (marked ldquoDo Not Userdquo) and stored under proper conditions until they have received information from vaccine manufacturers regarding the viability of the vaccine
bull Sites must inform MDH when an excursion occurs
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Clinicians Storage and Handling Mishap Checklist (wwwhealthstatemnusdivsidepcimmunize ipivaxchklstpdf)
Page 40 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 49
Goal of this question Ensure proper placement of vaccines in the storage unit
Note These are all recommendations (best practices) not requirements
Helpful information bull Store vaccine in the middle of the compartment two to three inches away from the coils walls floor and cold air vent The temperature near the floor and walls of the unit differs from that in the middle of the compartment and the cold air vent can freeze refrigerated vaccines
4 Storage amp Handling Per Unit Vaccine Placement
Question 49 Look inside the unit to answer the questions below
A Are vaccines placed in the middle of the unit with space between vaccinesand the sideback of the unit to allow cold air to circulate
Yes No [O]
B Are vaccines stored in their original packages Yes No [O]
C Are there water bottles (for refrigerators) or frozen water bottles (forfreezers) in the unit
Yes No [O]
D Are vaccines store in the doors vegetable bins under or near cooling ventsor on the floor of the unit
Yes [O] No
E Is food being stored in the unit Yes [O] No
Review CDC Recommendation
Vaccines should be stored in their original manufacturer (or CDC centralized distributor) packaging They should be placed in the middle of the unit with space between the vaccines and the sideback of the unit to allow cold air to circulate Vaccines SHOULD NOT be stored in the doors vegetable bins or floor of the unit or under or near cooling vents and there should not be any food inthe unit Water bottles (for refrigerators) or frozen water bottles (for freezers) should be placed throughout each storage unit inorder to (1) stabilize or extend temperatures during a power outage and (2) to serve as physical blocks preventing the placementof vaccines in areas of the unit that are at higher risk for temperature excursions (such as in doors vegetable bins floor ornearunder cooling vents)
bull Vaccines should be kept in their original packaging to Protect them from light Help prevent medication errors by making labels easier to read Provide a moisture barrier that serves as insulation in case of an out-of-range temperature power outage door left open or mechanical failure Simplify managing vaccine inventory
bull Store water bottles in the doors on the floor and near the cold air vent in the refrigerator and frozen water bottles in the freezer to help maintain a stable temperature if there is a power failure and when the door is opened frequently Too many water bottles in the door can prevent the door from closing tightly Mark water bottles ldquoDo Not Drinkrdquo
bull Do not store vaccine in the door or drawers of the refrigerator or freezer Vegetable bins and crisper drawers should be removed from refrigerators or used to store other medical supplies or water bottles
bull If vaccine is stored in a household combination refrigeratorfreezer The top shelf should not be used for storing vaccine because the cold air vent blowing from the freezer will freeze vaccine located there If you must use the top shelf of this type of unit place water bottles underneath the cold air vent to prevent vaccine from being stored there It is recommended that only the refrigerator be used for vaccine storage and a separate stand-alone freezer be used to store frozen vaccine
bull Must not store food or beverages in the refrigerator or freezer because frequent opening of doors can lead to temperature variations that may affect vaccine viability There is also a risk of contaminating vaccines
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Guide (wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml) bull Vaccine Storage Tip Sheet on IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml)
IPI Advisor Manual | February 2017 Page 41
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 4104 Storage amp Handling Per Unit Disconnection from Power Source
Question 410 Ask the provider to demonstrate what measures are taken to ensure that vaccine storage units are notaccidentally physically disconnected from the power supply Which of the following describes the measure(s) taken on this unit
Note to Reviewer bull Large hospitals and healthcare systems may not have the ability to demonstrate labels on plugs or circuitbreakers In such cases verify that the practice has a comprehensive policy and standard operatingprocedures in place to prevent the vaccine storage unit from being physically disconnected from thepower supply
bull While back-up generators may ensure power to the overall facility this question ONLY addresses thevaccine storage unit being accidentally disconnected from the power source either through the plug orthe circuit breaker
Answers A ldquoDo not disconnectrdquo labels on the plug (Choose all that B ldquoWarningrdquo label on the circuit breaker box
apply) C Hard-wired (ie built-in) and has a ldquoDo not disconnectrdquo label on thecircuit breaker box D Hospital or large health care system with a comprehensive written policyand standard operating procedures detailing measures taken to preventvaccine storage units from being accidentally disconnected from the powersupply E No acceptable measures for preventing accidental disconnection frompower supply [X]
[X] The response is non-compliant if only A only B or E is selected
Review CDC Requirement
VFC providers must take steps to protect the power source for all vaccine storage equipment by means of having clear warninglabels on both the plug and the circuit breaker associated with all vaccine storage units Large hospitals and healthcare systems canmeet this requirement by demonstrating that they have comprehensive policies and standard operating procedures to preventvaccine storage units from being physically disconnected from the power supply
Goal of this question Decrease the chance that a vaccine storage unit will be accidently unplugged or power will be turned off while vaccine is in the unit This question addresses only what measures the site has taken to ensure the storage unit is not physically disconnected from its power source
If the site uses labels on the plugs and circuit breakers perform a visual inspection to assess whether the way the stickers are positioned make it clear and obvious to anyone that these units are not to be disconnected
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Do Not Unplug and Warning stickers are included in the folder or available to order on the For
Professionals Order Form (wwwhealthstatemnusdivsidepcimmunizeordermathtml)
Note Once you have completed the 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet for each unit return to the questionnaire to complete sections 5 and 6
Page 42 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
- -
Section 5 Storage amp Handling Site-Wide Question 51
5 Storage amp Handling Site Wide Discussion of Cost amp Quantity of Vaccine
Question 51 Have a discussion with the provider about the cost and quantity of VFC vaccines they are responsible for annually Address the points listed in the note to reviewer below
Note to Reviewer bull Vaccine Shipped (Required) Share the cost of VFC vaccines shipped to the provider in the last calendaryear to make sure the provider understands the contribution made by the VFC Program to their practiceFor new providers who do not have ldquocalendar yearrdquo data share either the actual cost of their currentinventory or use the cost of 10 VFC doses of each of the ACIP-recommended vaccines (approximately $7000) to help estimate their annual cost
bull Storage amp Handling (Required) Make sure the provider understands the cost of vaccines for which they are responsible when they make decisions about purchasing recommended vaccine storage and temperature monitoring equipment
Answer I have discussed with the provider the cost and quantity of vaccines ordered in the previous calendar year
Goal of this question Inform sites of the quantity and value of vaccines that they receive as part of the MnVFC program Providers often donrsquot realize the value of the vaccine in their unit This information is included on your clinic list and on the one page site-specific information
Helpful information bull This discussion must occur and the box on the questionnaire must be checked bull If there isnrsquot actual vaccine value information available tell the site that one vaccine order that includes a box of each of the ACIP recommended vaccines costs approximately $7000
bull MDH may not have specific information for individual sites if they receive vaccine from a central warehouse or pharmacy For those sites MDH will give you numbers for the whole system so you can discuss system wide data as appropriate If individual site information is also included it is usually just varicella-containing vaccines that must be shipped directly to the site
Question 52
5 Storage amp Handling Site Wide Dorm Style Units
Question 52 Determine whether the provider has any dorm-style units on site and answer the questions below
Note to Reviewer A dormitory-style refrigerator is a unit that has both refrigerator and freezer compartments behind a singleexterior door Dorm-style units also have an evaporator plate (cooling coil) which is usually located insidean icemaker compartment (freezer) within the refrigerator
A Does the provider have any dorm-style units that are used at any time tostore vaccines
Yes [X] No (Skip to question 53)
B Does the provider have sufficient space in existing compliant vaccinestorage units to store all vaccines without use of the dorm-style unit at any time
Yes No [X]
Review CDC Requirement
Dorm- and bar-style units are prohibited for vaccine storage Vaccines stored in dorm-style units are considered non-viable and must be returned to the centralized distributor CDC recommends the following vaccine storage unit types (in order of preference)pharmaceutical grade stand-alone or combination units (preferred) householdcommercial stand-alone unitshouseholdcommercial combination units using the refrigerator section only
Goal of this question Ensure no vaccine is stored in dorm-style units even for short periods of time Encourage them to label any units ldquoNo Vaccine Storage Allowedrdquo Vaccine stored in these units is considered non-viable If a site is using a dorm-style unit call the MnVFC program (651-201-5522)
Resource Section 8 in the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 43
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 535 Storage amp Handling Site Wide Storage Unit Space Availability
Question 53 Does the provider have sufficient room across storage units to store current stock as well as anyadditional stock acquired during peak season without overcrowding
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have sufficient storage space to accommodate vaccine stock at the busiest time of year without overcrowding
Goal of this question Ensure that sites have sufficient space in their units to maintain vaccines at the busiest time of year Overcrowding of vaccine limits air circulation and affects the unitrsquos ability to maintain stable temperatures
Helpful information bull Look for signs of overcrowding such as vaccines that are pushed up against the wall bins that are overflowing or storage units that are full during non-peak seasons
Discuss immediate actions if the unit is overcrowded Move some of their vaccines order less vaccine more frequently (once per month preferably) andor purchase another storage unit for overflow
Resource bull Section 8 MnVFC Policy and Procedure Manual
Page 44 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 545 Storage amp Handling Site Wide Expired Vaccines
Question 54 Look in each unit Are there expired vaccines in any of the vaccine storage units at this site
Answers (Choose one)
Yes [X] No
Review CDC Requirement
Vaccines should be rotated weekly and when a new shipment comes in so that longer-dated vaccines are stored behind shorter-dated vaccines If vaccines expire they can no longer be stored in the same storage unit with viable vaccines They must be placedin a container or bag clearly labeled ldquoDo not userdquo and separated from viable vaccines to prevent inadvertent use Expired vaccinemust be returned to the centralized distributor within six months of expiration
Goal of this question Ensure there is no expired vaccine in any storage unit
Helpful information bull Sites can prevent their stock from expiring by rotating vaccines every week andor when a new shipment arrives Longer-dated vaccines are stored towards the back of the unit and shorter-dated vaccines are up front
bull Pay attention to vaccines that expire within the next three months Consider transferring vaccine that will expire soon to another MnVFC-enrolled site that will use the vaccine preferably a site close by It is the transferring sitersquos responsibility to arrange the transfer of the vaccine Be sure to complete the MDH Vaccine Transfer Record form and send it to MDH If they are having difficulty finding a location to accept vaccine contact MDH
bull This is a great opportunity to educate sites about the MDH Nonviable Vaccine Form and the process for returning vaccine The VFC program does get some credit for taxes and fees on vaccine that is returned to the distribution center
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MDH Nonviable Vaccine Form and MDH Vaccine Transfer Record on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfcformshtml)
IPI Advisor Manual | February 2017 Page 45
The 2017 MnVFC Site Visit Paperwork Chapter 4
- -
-
Question 555 Storage amp Handling Site Wide Back up Thermometer
Question 55 Does the provider have a readily available back-up thermometer with a current and valid certificate ofcalibration testing
Note to Reviewer ldquoReadily availablerdquo means that the thermometer is available to perform twice-a-day monitoring for a unit asrequired CDC recommends that the back-up thermometer be maintained on site
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have a readily available back-up thermometer with a current and valid certificate of calibration testing Toprevent the certificates of calibration testing of the primary and back-up thermometers from expiring at the same time the date of calibration testing (or issue date) of the back-up thermometer should be different from the date of calibration testing (or issue date) of the primary thermometer As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meetsVFC program requirements
Goal of this question Ensure sites have one calibrated back-up thermometer onsite that is readily available in the event that the temperature monitoring device in unit fails transportation of vaccine is needed or there are other unexpected circumstances
Helpful information bull As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meets VFC Program requirements
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 56 5 Storage amp Handling Site Wide Preparation of Vaccine
Question 56 When does this provider prepare vaccine for administration to the patient
Note to Reviewer For mass vaccination clinics if one type of vaccine is offered providers may pre-draw up to 10 doses Ifusing pre-filled syringes pre-drawing also means activating the syringe by removing the needle guard orattaching a needle
Answers (Choose all that
apply)
Prepare dose immediately before administration Pre-draw doses for upcoming patients (in a regular clinicpractice) [O] Pre-draw up to 10 doses (in a mass-vaccination clinic) Pre-draw more than 10 doses (in a mass-vaccination clinic) [O] Other [O]
Review CDC Recommendation
CDC recommends preparing vaccines immediately prior to administration in order to assure viability of vaccine and prevent vaccinewastage Vaccines that are not administered immediately are at risk of exposure to temperatures outside of the required rangewhich can affect vaccine viability and ultimately can leave children unprotected against vaccine-preventable diseases
Goal of this question Discuss proper timing and preparation of vaccine(s) for administration These are recommendations not requirements
Helpful information bull Educate staff on the importance of preparing vaccine immediately before administration Pre-drawing of vaccines may lead to concerns related to vaccine viability potency sterility and wastage
Page 46 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 6 Inventory Question 61
6 Inventory Inventory Comparison
Question 61 Visually inspect storage units to determine if existing supply of vaccines proportionately mirrorspopulations served Choose the most accurate statement below
Note to Reviewer bull CDC recommends that providers maintain a four-week supply of inventory bull For this question do not take into account vaccine types that the provider does not order Here simply
make sure that overall the vaccines in the providerrsquos storage units are available in sufficient amounts toserve their patient population
Answers (Choose one)
The current vaccine inventory proportionately reflects the populations identified Only public stock is insufficient [X] Only private stock is insufficient [X] Both public and private stock are insufficient [X] Site uses the replacement method but does not appear to have enough vaccine for their population [X] Other [X]
Review CDC Requirement
VFC providers must order and stock routine vaccines in accordance with their patient population in order to prevent missedvaccination opportunities Having sufficient amounts of all stocks prevents the inadvertent use of VFC vaccines for non-VFC-eligiblepatients and vice versa
Goal of this question Assess whether the site is ordering appropriate quantities of vaccine for the population they serve at their site
Helpful information bull If the site sees 30 percent private-pay patients and 70 percent VFC the stock in their storage units should reflect that proportion If you donrsquot know you can ask the site about their population
bull This is meant to be a general assessment so in a big site if they have only a small amount of vaccine that may indicate an issue with vaccine management
bull CDC recommends smaller more frequent orders (ie monthly) rather than large orders to minimize the amount of vaccine loss if an incident occurs during shipment or in the storage unit Sites should not order more frequently than once a month
bull Sites using the replacement method will only have one stock but it should appear to be large enough for their population
bull Only assess the vaccine types that the site currently stocks in their unit We know there are sites that do not offer all ACIP-recommended vaccines for various reasons That issue will be addressed in question 62
IPI Advisor Manual | February 2017 Page 47
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 626 Inventory ACIP Recommended Vaccines
Question 62 Review providerrsquos current inventory to answer the questions below
A Does the provider offer all routine ACIP-recommendedvaccines for their patient population
Yes (Skip to question C) No [X] Offers all except varicella because direct ship ofvaccine is unavailable from manufacturer
B Which routine vaccines are NOT being offered DTaP Hepatitis A Hepatitis B HIB HPV Influenza Meningococcal
MMR Pneumococcal Polio Rotavirus TdapTd Varicella
C According to Immunization Program Policy does theprovider make accessible all non-routine ACIP-recommended vaccines for those VFC patients whomeet the criteria for receiving them
Yes (Skip to question 63) No [X]
D Which non-routine vaccines are NOT being offered Pneumococcal polysaccharide vaccine (PPSV23) Meningococcal Group B (MenB) Other
Review CDC Requirement
VFC providers agree to comply with immunization schedules dosages and contraindications that are established by the Advisory Committee on Immunization Practices (ACIP) for the vaccines identified and agreed upon in the Provider Agreement UNLESS bull In the VFC providers medical judgment and in accordance with accepted medical practice the VFC provider deems such
compliance to be medically inappropriate for the child bull The particular requirements contradict state law including laws pertaining to religious and other exemptions The VFC program entitles children to the following vaccines DTaP Hepatitis A Hepatitis B HIB HPV Influenza MeningococcalMMR Pneumococcal Polio Rotavirus TdapTd and Varicella VFC providers are also required to ensure that VFC-eligible children have access to non-routine vaccines as needed
Goal of this question Assess if the site is offering all the ACIP-recommended vaccines for the population they serve and these vaccines are in stock on the day of the visit It is important that every MnVFC-eligible child that comes to a providerrsquos office for an immunization is vaccinated
Helpful information bull The Advisory Committee on Immunization Practices (ACIP) is a group of medical and public health experts that develops recommendations on how to use vaccines to control diseases in the United States
bull Specialty providers are not required to offer all routine vaccines but should provide the vaccines appropriate for their population
bull If the site does not offer all routine ACIP-recommended vaccines appropriate for their population check the ldquoNordquo box in Part A then check the appropriate box(es) in Part B for any vaccines not offered Please contact MDH as this situation offers us the opportunity to provide education to the site
bull For non-routine vaccines they must either be in stock or the site must have an alternative protocol in the routine management plan that ensures these children have access when applicable
Resources bull IAC Diseases and Vaccines (wwwimmunizeorgvaccines) bull CDC Advisory Committee on Immunization Practices (ACIP) (wwwcdcgovvaccinesacipindexhtml)
Page 48 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 636 Inventory Separation of Stock
Question 63 Observe how the provider differentiates stock in each storage unit to answer the questions below
A Is it clear which vaccines belong to public stock andwhich belong to private stock
Yes No [X] Not applicable replacement site
B Is it clear which vaccines belong to VFC stock andwhich belong to UUAV stock
Yes No [X] Not applicable replacement site Not applicable not UUAV-enrolled site
Review CDC Requirement
In order to ensure that VFC vaccines are only administered to VFC-eligible children VFC providers that serve both VFC and non-VFCshyeligible children must maintain their vaccine inventories in such a way that they can clearly differentiate public stock from privatestock as well as VFC from other public stock
Goal of this question Assess whether the site can distinguish between MnVFC vaccine and private vaccine If they participate in the Uninsured and Underinsured Adult Vaccine (UUAV) program they should also be able to distinguish between MnVFC stock and UUAV stock Some sites use labels bins boxes etc to differentiate their stock If it is not clear how the site differentiates their stock discuss vaccine management with the staff For follow-up call MDH to discuss doing a follow-up site visit
Sites using the replacement method will not have separate stocksmdashthis is an approved alternative method for keeping track of vaccine
Resource bull Section 10 of the MnVFC Policy and Procedure Manual
IPI Advisor Manual | February 2017 Page 49
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
MnVFC Site Visit Storage and Handling Per Unit Answer Sheet 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet MnVFC PIN ___________________
Question number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
Temperature Monitoring Device Questions Questions 43 47 must be answered separately for the freezer and refrigerator if the unit is a combo Be sure to document responses in the appropriate column
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
All the questions on the Site Visit Storage amp Handling Per Unit Answer Sheet have been discussed previously in section 4 of this manual Use this sheet to record information about all the units at the site visit You will need one sheet for each unit If it is a combination unit (either pharmaceutical or household) you can record both sections on one sheet If they have stand-alone units use one sheet for each unit Do not enter the answers to the questions in section 4 of the questionnaire
If you need more information about any of the questions refer back to the main questionnairemdashthe complete question additional guidance including notes to the reviewer and the CDC requirements are there Also if the site is not meeting the requirement you will go back to the questionnaire to complete the ldquoActions if Non-compliantrdquo section including the root cause analysis and follow-up sections
When you have completed the assessment of all the storage units remember to go back to the questionnaire to complete sections 5 and 6
Page 50 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
ndash
ndash
MnVFC Provider Follow-up PlanThe goal of the Provider Follow-up Plan is to communicate with the site all of the VFC requirements any unmet requirements found during your site visit and the timeline for completing the required action The left hand column is a box to check for ldquoUnmetrdquo requirements
Helpful information bull The form can be used to review what the site is doing well and what they need to work on
bull For requirements that have specific documentation that needs to be sent to you use the notes section
2017 MnVFC Provider Follow-up Plan Site _______________________________________________ MnVFC PIN ____________ Date of Visit ___________
Thank you for participating in this MnVFC compliance site visit Please review this visit summary including follow-up actions and timelines for completion Unmet MnVFC requirements and recommendations have a checked box next to them The goal of this plan is to support you with successfully implementing the program and improving access to vaccines for VFC-eligible children
Unmet Question VFC Requirements Section 1 Changes to Key Staff
Q12 Change in the Medical Director Immunization Manager Vaccine Coordinator or back-upKey Staff must be communicated to the immunization program by emailing healthmnvfcstatemnus Changes Notes
Q12 Key staff must complete the annual training on VFC program requirements and print theAnnual Training certificate of completion Documentation Required Action
Staff that have not completed the MnVFC online training must complete it and send acopy of the certificate to the reviewer Training can be found on the MnVFC website (wwwhealthstatemnusvfc) Due date 1 month
Notes
Unmet Question VFC Requirements Section 2 Eligibility
Q21 Provider staff must possess a working knowledge of all VFC eligibility criteria and use thoseVFC Eligibility criteria to screen children prior to administering VFC vaccines
Categories Notes
bull This form provides documentation needed for follow-up actions when you send your thank you email
The second to last page of the Provider Follow-up Plan has a summary of the MnVFC program recommendations These are to remind the site about best practices they may want to improve upon even though they are not yet requirements of the program For example you could discuss the recommendation about storage units if they currently have a combination household unit and are using both sections
The last section is for your signature and the person you met with In most sites it will be the immunization manager or vaccine coordinator who signs the form unless the medical director attended the site visit You keep the original copy and the site will need to keep a copy for themselves
To be completed by the site visit reviewer
I acknowledge that a VFC site visit was performed on __________________ (visit date) The follow-up plan which includes a list of all current VFC program requirements and recommendations assessed during the visit and any required follow-up actions was provided at the end of the visit
Site visit reviewer
Phone
Reviewer Signature Date
To be completed by the provider
I acknowledge that our practice took part in the VFC site visit noted above I understand the findings of the visit and any required actions that must be taken by our office in order to meet VFC program requirements
Medical Director (or designee) Name Title
Medical Director (or designee) Signature Date
IPI Advisor Manual | February 2017 Page 51
The 2017 MnVFC Site Visit Paperwork Chapter 4
After the Site Visit Send a thank you email highlighting the unmet requirements documents you need from the site to resolve the issue(s) and the date you need them Make sure to include the link to the Site Visit Survey (httpssurveyvovicicomseashxs=56206EE334CE0B14)
Please refer to Chapter 3 for more information about future follow-up required after the visit including forms and documentation
Resource bull Sample Thank You letter on IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml)
Chapter 5
IPI Advisor Resource List MnVFC Program 651-201-5522
MnVFC wwwhealthstatemnusvfc
bull Separate Stock and Replacement Method Policies and Procedures Manuals bull Online trainings bull MnVFC Announcements sign up to receive them via email bull Ordering MDH vaccine bull MnVFC forms Screening forms Reporting forms Others MDH Nonviable Vaccine Form MDH Vaccine Transfer Record and Vaccine Borrowing Report
bull MnVFC promotional materials bull Immunization Billing Guidance for MnVFC and Immunization Billing Guidance for MnVFC Replacement Sites Immunization Practices Improvement Program (IPI) wwwhealthstatemnusdivsidepcimmunizeipi
bull IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml) bull IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml) IPI Resource Folder Contents (wwwhealthstatemnusdivsidepcimmunizeipiipifolderpdf)
Minnesota Immunization Information Connection (MIIC) wwwhealthstatemnusmiic
bull MIIC regions and regional coordinators
Clinical Practice MDH Immunization Program wwwhealthstatemnusimmunize
Got Your Shots News wwwhealthstatemnusdivsidepcnewslettersgys
MDH Immunization Information for Health Care Providers wwwhealthstatemnusdivsidepcimmunizehcp
bull Got Your Shots A Providers Guide to Immunization in Minnesota bull Vaccine protocols bull Forms for tracking patient immunizations bull Immunization schedules for Health Care Providers Immunization Action Coalition (IAC) wwwimmunizeorg
bull Ask the Experts bull VISs (Vaccine Information Statements and translations) bull Administration screening questions bull Medical management of vaccine reactions bull Order form for Californiarsquos Immunization Technique DVD Best Practices with Infants Children and Adults
Page 52 IPI Advisor Manual| February 2017
IPI Advisor Resource List Chapter 5
CDC ldquoPink Bookrdquo wwwcdcgovvaccinespubspinkbookindexhtml
CDC Advisory Committee on Immunization Practices (ACIP) wwwcdcgovvaccinesacip
CDC Vaccines and Immunizations wwwcdcgovvaccines
VAERS reporting httpvaershhsgovindex
Storage and Handling Got Your Shots Providers Guide ndash Managing Vaccine wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml
MnVFC Guide to Temperature Monitoring Devices wwwhealthstatemnusvfc
MDH Clinicianrsquos Vaccine Mishap Checklist wwwhealthstatemnusdivsidepcimmunizeipivaxchklstpdf
MDH Vaccine Storage Guide wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml
CDC Vaccine Storage and Handling Toolkit wwwcdcgovvaccinesrecsstoragetoolkit
You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Vaccine manufacturer phone numbers wwwcdcgovvaccinespubspinkbookdownloadsappendicesFcontact-info-manufactpdf
IAC Checklist for Safe Vaccine Handling and Storage wwwimmunizeorgcatgdp3035pdf
IAC Donrsquot Be Guilty of These Errors in Vaccine Storage and Handling wwwimmunizeorgcatgdp3036pdf
Additional Resources Print materials from MDH ndash order forms wwwhealthstatemnusdivsidepcimmunizeordermathtml
Vaccine Education Center ndash Childrenrsquos Hospital of Philadelphia wwwchopeduservicevaccine-education-centerhomehtml
California Department of Public Health ndash Interactive training on vaccine administration and storage and handling handout on transporting vaccine and how to package wwwezizorg
IPI Advisor Manual | February 2017 Page 53
IPI Advisor Resource List Chapter 5
CDC vaccine price list wwwcdcgovvaccinesprogramsvfcawardeesvaccine-managementprice-listindexhtml
Vaccine Information Statements (VIS) wwwcdcgovvaccineshcpvisindexhtml
CEU Opportunities CDC Immunization Education and Training wwwcdcgovvaccinesedindexhtml
Immunization You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Page 54 IPI Advisor Manual| February 2017
- Introduction
-
- Welcome to the Immunization Practice Improvement (IPI) Program
- Contact Information
-
- Chapter 1
- Requirements to Participate in the MnVFC Program
- Vaccines for Children Program
- Chapter 2
- Reimbursement for MnVFC Visits
- Types of Visits
- Your MnVFC Clinical CoordinatorPlanner
- New IPI Advisor Training Requirements
- Your Role as an IPI Advisor
- Reasons MDH Would Do All or Part of a Visit
- Chapter 3
- Future follow-up
- Conducting the Visit
- Preparing for the Visit
- Information for the Visit
- Site Visit Checklist
- Scheduling the Visit
- Chapter 4
- After the Site Visit
- MnVFC Provider Follow-up Plan
- MnVFC Site Visit Storage and Handling Per Unit Answer Sheet
- Section 6 Inventory
- Section 5 Storage amp Handling Site-Wide
- Section 4 Storage amp Handling Per Unit
- Section 3 Documentation
- Section 2 Eligibility
- Section 1 Provider Details
- The Site Visit Reviewer Legend
- MnVFC Site Visit Questionnaire
- Required Paperwork for Site Visits
- Chapter 5
-
IPI Advisor Manual | February 2017 Page 35
The 2017 MnVFC Site Visit Paperwork Chapter 4
bull It is recommended that sites download and review data weekly Discuss with sites that reviewing temperature monitoring device data also includes responding appropriately if they identify out-of-range temps
bull There is sometimes confusion about the difference between a data logger and a continuous temperature monitoring system Here are some differences
Data Loggers Continuous Monitoring Systems Have an external display similar to thermometers May or may not have an external display Have a detachable probe Probe is usually attached to transmitter Need to be plugged into the computer or cradle to download information on a regular schedule
Wirelessly sends data to computer system
Create a file of data that needs to be saved on the computer
Data is stored within the system not a separate file
Doesnrsquot allow documentation of twice a day temperature checks in the file
May allow documentation of twice a day temperature checks within the system
More about the 2018 requirement for a continuous temperature monitoring device
Required Features bull The continuous temperature monitoring device must have Continuous monitoring and recording capabilities to track and record temperatures over time The capacity to routinely download temperature data to a computer (recommended at least weekly) or wirelessly transmit data Detachable probe in a bottle filled with a thermal buffer (eg bio-safe glycol) if the data logger needs to be detached in order to download data Active temperature display
Recommended Features bull MnVFC recommends continuous temperature monitoring devices with Alarm for out-of-range temperatures Accuracy within +-1degF (+- 05degC) Low battery indicator Display of current minimum and maximum temperatures Memory storage of at least 4000 readings User programmable logging intervals (eg the user can set how often the device records the temperature)
Note that these are all currently recommendations not requirements yet
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Page 36 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 45
Goal of this question Ensure the temperature monitoring device is properly calibrated The certificate of calibration testing means that the device has been tested and it is accurately measuring temperatures within established testing limits The certificate of calibration ensures that the device meets all the required components
Helpful information bull The provider is always responsible for having a current certificate of calibration (or copy) on-site
bull To be considered ldquovalidrdquo a certificate of calibration must contain these required elements Modeldevice name or number Serial number
4 Storage amp Handling Per Unit Certificate of Calibration Testing
Review CDC Requirement
Certificates of calibration testing provide confidence that the temperature monitoring device is measuring temperaturesaccurately All units storing VFC vaccines must have a calibrated temperature monitoring device with a current and valid certificateof calibration testing All certificates must contain modeldevice name or number serial number date of calibration testing (report or issue date) and Instrument Passed testingInstrument in Tolerance (Recommended uncertainty = +-05ordm C (+-1ordm F))
Question 45
Note to Reviewer
A
B
C
D
E
Review the certificate of calibration testing for the temperature monitoring device in this section of the storage unit and answer the questions below
bull How to determine certificate of calibration testing expiration date 1) Identify the certificate issuecalibration date 2) Apply the Immunization Program-required frequency for calibration testing Example If the
issuecalibration date is 12312013 and Immunization Program policy requires testing every twoyears the expiration date is 12312015
bull Certificates must include all of the below bull ModelDevice Name or Number bull Serial Number bull Date of Calibration Testing (Report or Issue Date) bull Instrument Passed testing (Instrument in Tolerance)
Is there a certificate of calibration testing for the temperature monitoring Yes device in this section of the storage unit No [X]
What is the date of calibration for the temperature monitoring device in this section of the storage unit
What is the certificatersquos date of expiration based on ImmunizationProgram policy (See note to reviewer to determine expiration date) [X] Follow-up is required if
certificate is expired
Does the certificate contain all the necessary items listed in the Note to Yes Reviewer No [X]
Who is responsible for supplying the current and valid certificate of Provider calibration for this temperature monitoring device
Date of calibration testing (report or issue date) Note If there is no expiration date the certificate expires 2 years from the date of calibration Whether the instrument passed or failed testing (or instrument in tolerancenot in tolerance)
bull Recommended element Documented uncertainty of +- 1degF [05degC]
If these elements are present the certificate is considered valid If the certificate contains information about the recommended element or the entity that issued the certificate that is helpful but not required
To determine if a certificate of calibration testing was issued by an appropriate entity check to see if the certificate indicates one or more of these items (this is the wording used to help sites evaluate if their calibration is accurate but is not required on the certificate itself to be considered valid)
bull Conforms to ISO 17025 bull Performed by an ILACMRA Signatory body accredited laboratory You can review this list of the ILAC MRA and Signatories (httpilacorgilac-mra-and-signatories)
bull Traceable to the standards maintained by NIST bull Meets specifications and testing requirements for the American Society for Testing and Materials (ASTM) Standard E2877 tolerance Class F (le 05 degC) or better
bull Includes reference to another acceptable accuracy validation method such as comparison to other traceable reference standards or tests at thermometric fixed points
Note CDC recommends that certifications be issued for the entire monitoring unit (detachable probe data logger etc) and not individual certificates for each component
IPI Advisor Manual | February 2017 Page 37
The 2017 MnVFC Site Visit Paperwork Chapter 4
For 45 E the provider is always responsible for supplying the current and valid certificate of calibration for a temperature monitoring device
bull Tip If the temperature monitoring device has a sticker on the back with the calibration date the site can usually call the company who calibrated the device and get a copy of the certificate if they donrsquot have one
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 46 4 Storage amp Handling Per Unit Probe Placement
Question 46 Is the probe properly placed in this section of the storage unit
Note to Reviewer ldquoProperlyrdquo means that the probe in a commercial or household unit is placed in a central area of the unitdirectly with the vaccines Probes should not be placed in the doors near or against the walls close to vents or on the floor of the unit The only allowable exemption related to this requirement is for providerswho have pharmaceutical storage units (built for vaccine storage) that have either (1) a built-intemperature monitoring device OR (2) a dedicated port for the probe that dictates the placement of theprobe
Answers (Choose one)
Yes No [X]
Review CDC Requirement
The probe must be placed in a central area of the section of the storage unit directly with the vaccines in order to properly measurevaccine temperature The probe should not be placed in the door near or against the walls close to vents or on the floor of theunit For pharmaceutical units with a built-in temperature monitoring device or a dedicated port for a probe that is not in thecenter of the section of the storage unit consult your Immunization Program for guidance on placement
Goal of this question Make sure the temperature monitoring device is in the best location to accurately measure the temperature of the vaccines stored in the unit
Helpful information bull The probe of the temperature monitoring device should be placed directly with the vaccines in the middle of the unit The ONLY allowable exception is for pharmaceutical storage units that have either a built-in thermometer or a dedicated port for the probe that indicates placement of the probe
bull Temperatures can vary within the unit especially household units bull Call MDH at 651-201-5522 if you have questions
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Guide (wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml)
Page 38 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 474 Storage amp Handling Per Unit Temperature Documentation
Question 47 Review the temperature documentation over the past three months for this section of the storage unit todetermine whether the provider has a process in place for properly documenting temperatures twice aday Answer the questions below
A Are there two temperature readings recorded for this section of the storage unit per day
Yes No [X]
B Is there a time date and name (or initials) recorded for each reading Yes No [X]
C What is the current temperature and minmax temperatures (if available) inthis section of the storage unit Use the reviewerrsquos thermometer if the providerrsquos temperature monitoringdevice does not have a current valid certificate of calibration testing or the probe is not properly placed in this section of the storage unit
Current Temperature Minimum Temperature Maximum Temperature Fahrenheit Celsius
D Based on your review of the providerrsquos recent temperature documentationincluding the current temperature is this section of the storage unitmaintaining appropriate temperatures
Yes No [X] Not enough information [X]
Review CDC Requirement
Vaccines must be stored under appropriate temperatures as described in the package inserts at all times Acceptable temperature ranges vary by vaccine type and the range is 36deg F and 46deg F (2deg C and 8deg C) and for frozen vaccines the range is -58deg F and +5deg F (shy50deg C and -15deg C) Exposure to temperatures outside of those included in the package inserts could affect vaccine viability andultimately could leave children unprotected against vaccine-preventable diseases In order to maintain awareness of storage unittemperatures and ensure that vaccines are being stored at appropriate temperatures at all times VFC providers are required to monitor and document temperatures for all vaccine storage units at least twice a day Temperature documentation must contain (1) at least two temperature readings per day (2) the time and date of each reading and (3) the name (or initials) of the personwho assessed and recorded the readings CDC also recommends that VFC providers record the minimum and maximumtemperatures of each unit once each workday (preferably in the morning)
Goal of this question Ensure the temperature is being monitored twice daily is within the required range and documented correctly Use your thermometer to check the temperature if the sitersquos temperature monitoring devicersquos probe is not properly placed or there is not a current certificate of calibration Place your thermometer in the unit at the beginning of the visit to allow sufficient time to reach an accurate temperature The purpose of using your thermometer is to ensure the vaccine is being stored at the proper temperature not to ldquovalidaterdquo their reading
Question 47 D is an assessment question based on information you have learned during your visit You might answer ldquonot enough informationrdquo if the unit is new and they donrsquot have at least three months of data or if the unit is only used as overflow and they are inconsistent with temperature monitoring Mark ldquoNordquo if you have reason to believe the storage unit is not maintaining temperatures properly
Helpful information bull All sites must document temperatures twice a day every day the site is open even if they have a data logger or continuous monitoring system
bull Sites can document the information electronically with some continuous monitoring systems as long as it can show what the current temp is the date time and initials of the person checking ndash this needs to be someone at the site ndash not checking remotely or centrally for a large site or system The site must be able to produce these records during their site visit Reviewing these files can be a challenge due to large volumes and lots of paper
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Temperature Logs on Managing Vaccine (wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml)
IPI Advisor Manual | February 2017 Page 39
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 484 Storage amp Handling Per Unit Temperature Excursions
Question 48 In the event that a temperature excursion(s) occurred in this unit within the last three months requestand review documentation of actions taken to determine whether the provider has a process for properlyaddressing excursions Answer the questions below
A Were vaccines in this unit exposed to out-of-range temperatures in the lastthree months (including today)
Yes No (If no skip to question 49)
B Did the provider quarantine and label vaccines as ldquoDo not userdquo Yes No [X]
C Did the provider place vaccine in a unit where it can be stored under properconditions if applicable
Yes No [X]
D Did the provider contact the Immunization Program to report theexcursion
Yes No [X]
E Was the manufacturer contacted for documentation supporting theusability of the vaccine
Yes No [X]
Review CDC Requirement
The provider must document all excursions and actions taken including the following (1) Quarantine and label vaccines as ldquoDO NOTUSErdquo (2) Place vaccines in a unit where they can be stored under proper conditions (3) Contact the Immunization Program to report an excursion and (4) Contact the vaccine manufacturer to obtain documentation supporting the usability of the vaccine
Goal of this question Address any out-of-range temperatures (temperature excursions) identified in reviewing the last three months of temperature logs or during the site visit If there were any out-of-range temperatures did the site respond appropriately to the situation This is a great opportunity to discuss what to do in the event of an excursion The Clinicians Storage and Handling Mishap Checklist is in the IPI Site Visit information folder and is a good review of the process
Helpful information bull Sites need to know that an excursion does not automatically mean that exposed vaccines are non-viable or unusable Exposed vaccines must be quarantined (marked ldquoDo Not Userdquo) and stored under proper conditions until they have received information from vaccine manufacturers regarding the viability of the vaccine
bull Sites must inform MDH when an excursion occurs
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Clinicians Storage and Handling Mishap Checklist (wwwhealthstatemnusdivsidepcimmunize ipivaxchklstpdf)
Page 40 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 49
Goal of this question Ensure proper placement of vaccines in the storage unit
Note These are all recommendations (best practices) not requirements
Helpful information bull Store vaccine in the middle of the compartment two to three inches away from the coils walls floor and cold air vent The temperature near the floor and walls of the unit differs from that in the middle of the compartment and the cold air vent can freeze refrigerated vaccines
4 Storage amp Handling Per Unit Vaccine Placement
Question 49 Look inside the unit to answer the questions below
A Are vaccines placed in the middle of the unit with space between vaccinesand the sideback of the unit to allow cold air to circulate
Yes No [O]
B Are vaccines stored in their original packages Yes No [O]
C Are there water bottles (for refrigerators) or frozen water bottles (forfreezers) in the unit
Yes No [O]
D Are vaccines store in the doors vegetable bins under or near cooling ventsor on the floor of the unit
Yes [O] No
E Is food being stored in the unit Yes [O] No
Review CDC Recommendation
Vaccines should be stored in their original manufacturer (or CDC centralized distributor) packaging They should be placed in the middle of the unit with space between the vaccines and the sideback of the unit to allow cold air to circulate Vaccines SHOULD NOT be stored in the doors vegetable bins or floor of the unit or under or near cooling vents and there should not be any food inthe unit Water bottles (for refrigerators) or frozen water bottles (for freezers) should be placed throughout each storage unit inorder to (1) stabilize or extend temperatures during a power outage and (2) to serve as physical blocks preventing the placementof vaccines in areas of the unit that are at higher risk for temperature excursions (such as in doors vegetable bins floor ornearunder cooling vents)
bull Vaccines should be kept in their original packaging to Protect them from light Help prevent medication errors by making labels easier to read Provide a moisture barrier that serves as insulation in case of an out-of-range temperature power outage door left open or mechanical failure Simplify managing vaccine inventory
bull Store water bottles in the doors on the floor and near the cold air vent in the refrigerator and frozen water bottles in the freezer to help maintain a stable temperature if there is a power failure and when the door is opened frequently Too many water bottles in the door can prevent the door from closing tightly Mark water bottles ldquoDo Not Drinkrdquo
bull Do not store vaccine in the door or drawers of the refrigerator or freezer Vegetable bins and crisper drawers should be removed from refrigerators or used to store other medical supplies or water bottles
bull If vaccine is stored in a household combination refrigeratorfreezer The top shelf should not be used for storing vaccine because the cold air vent blowing from the freezer will freeze vaccine located there If you must use the top shelf of this type of unit place water bottles underneath the cold air vent to prevent vaccine from being stored there It is recommended that only the refrigerator be used for vaccine storage and a separate stand-alone freezer be used to store frozen vaccine
bull Must not store food or beverages in the refrigerator or freezer because frequent opening of doors can lead to temperature variations that may affect vaccine viability There is also a risk of contaminating vaccines
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Guide (wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml) bull Vaccine Storage Tip Sheet on IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml)
IPI Advisor Manual | February 2017 Page 41
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 4104 Storage amp Handling Per Unit Disconnection from Power Source
Question 410 Ask the provider to demonstrate what measures are taken to ensure that vaccine storage units are notaccidentally physically disconnected from the power supply Which of the following describes the measure(s) taken on this unit
Note to Reviewer bull Large hospitals and healthcare systems may not have the ability to demonstrate labels on plugs or circuitbreakers In such cases verify that the practice has a comprehensive policy and standard operatingprocedures in place to prevent the vaccine storage unit from being physically disconnected from thepower supply
bull While back-up generators may ensure power to the overall facility this question ONLY addresses thevaccine storage unit being accidentally disconnected from the power source either through the plug orthe circuit breaker
Answers A ldquoDo not disconnectrdquo labels on the plug (Choose all that B ldquoWarningrdquo label on the circuit breaker box
apply) C Hard-wired (ie built-in) and has a ldquoDo not disconnectrdquo label on thecircuit breaker box D Hospital or large health care system with a comprehensive written policyand standard operating procedures detailing measures taken to preventvaccine storage units from being accidentally disconnected from the powersupply E No acceptable measures for preventing accidental disconnection frompower supply [X]
[X] The response is non-compliant if only A only B or E is selected
Review CDC Requirement
VFC providers must take steps to protect the power source for all vaccine storage equipment by means of having clear warninglabels on both the plug and the circuit breaker associated with all vaccine storage units Large hospitals and healthcare systems canmeet this requirement by demonstrating that they have comprehensive policies and standard operating procedures to preventvaccine storage units from being physically disconnected from the power supply
Goal of this question Decrease the chance that a vaccine storage unit will be accidently unplugged or power will be turned off while vaccine is in the unit This question addresses only what measures the site has taken to ensure the storage unit is not physically disconnected from its power source
If the site uses labels on the plugs and circuit breakers perform a visual inspection to assess whether the way the stickers are positioned make it clear and obvious to anyone that these units are not to be disconnected
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Do Not Unplug and Warning stickers are included in the folder or available to order on the For
Professionals Order Form (wwwhealthstatemnusdivsidepcimmunizeordermathtml)
Note Once you have completed the 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet for each unit return to the questionnaire to complete sections 5 and 6
Page 42 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
- -
Section 5 Storage amp Handling Site-Wide Question 51
5 Storage amp Handling Site Wide Discussion of Cost amp Quantity of Vaccine
Question 51 Have a discussion with the provider about the cost and quantity of VFC vaccines they are responsible for annually Address the points listed in the note to reviewer below
Note to Reviewer bull Vaccine Shipped (Required) Share the cost of VFC vaccines shipped to the provider in the last calendaryear to make sure the provider understands the contribution made by the VFC Program to their practiceFor new providers who do not have ldquocalendar yearrdquo data share either the actual cost of their currentinventory or use the cost of 10 VFC doses of each of the ACIP-recommended vaccines (approximately $7000) to help estimate their annual cost
bull Storage amp Handling (Required) Make sure the provider understands the cost of vaccines for which they are responsible when they make decisions about purchasing recommended vaccine storage and temperature monitoring equipment
Answer I have discussed with the provider the cost and quantity of vaccines ordered in the previous calendar year
Goal of this question Inform sites of the quantity and value of vaccines that they receive as part of the MnVFC program Providers often donrsquot realize the value of the vaccine in their unit This information is included on your clinic list and on the one page site-specific information
Helpful information bull This discussion must occur and the box on the questionnaire must be checked bull If there isnrsquot actual vaccine value information available tell the site that one vaccine order that includes a box of each of the ACIP recommended vaccines costs approximately $7000
bull MDH may not have specific information for individual sites if they receive vaccine from a central warehouse or pharmacy For those sites MDH will give you numbers for the whole system so you can discuss system wide data as appropriate If individual site information is also included it is usually just varicella-containing vaccines that must be shipped directly to the site
Question 52
5 Storage amp Handling Site Wide Dorm Style Units
Question 52 Determine whether the provider has any dorm-style units on site and answer the questions below
Note to Reviewer A dormitory-style refrigerator is a unit that has both refrigerator and freezer compartments behind a singleexterior door Dorm-style units also have an evaporator plate (cooling coil) which is usually located insidean icemaker compartment (freezer) within the refrigerator
A Does the provider have any dorm-style units that are used at any time tostore vaccines
Yes [X] No (Skip to question 53)
B Does the provider have sufficient space in existing compliant vaccinestorage units to store all vaccines without use of the dorm-style unit at any time
Yes No [X]
Review CDC Requirement
Dorm- and bar-style units are prohibited for vaccine storage Vaccines stored in dorm-style units are considered non-viable and must be returned to the centralized distributor CDC recommends the following vaccine storage unit types (in order of preference)pharmaceutical grade stand-alone or combination units (preferred) householdcommercial stand-alone unitshouseholdcommercial combination units using the refrigerator section only
Goal of this question Ensure no vaccine is stored in dorm-style units even for short periods of time Encourage them to label any units ldquoNo Vaccine Storage Allowedrdquo Vaccine stored in these units is considered non-viable If a site is using a dorm-style unit call the MnVFC program (651-201-5522)
Resource Section 8 in the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 43
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 535 Storage amp Handling Site Wide Storage Unit Space Availability
Question 53 Does the provider have sufficient room across storage units to store current stock as well as anyadditional stock acquired during peak season without overcrowding
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have sufficient storage space to accommodate vaccine stock at the busiest time of year without overcrowding
Goal of this question Ensure that sites have sufficient space in their units to maintain vaccines at the busiest time of year Overcrowding of vaccine limits air circulation and affects the unitrsquos ability to maintain stable temperatures
Helpful information bull Look for signs of overcrowding such as vaccines that are pushed up against the wall bins that are overflowing or storage units that are full during non-peak seasons
Discuss immediate actions if the unit is overcrowded Move some of their vaccines order less vaccine more frequently (once per month preferably) andor purchase another storage unit for overflow
Resource bull Section 8 MnVFC Policy and Procedure Manual
Page 44 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 545 Storage amp Handling Site Wide Expired Vaccines
Question 54 Look in each unit Are there expired vaccines in any of the vaccine storage units at this site
Answers (Choose one)
Yes [X] No
Review CDC Requirement
Vaccines should be rotated weekly and when a new shipment comes in so that longer-dated vaccines are stored behind shorter-dated vaccines If vaccines expire they can no longer be stored in the same storage unit with viable vaccines They must be placedin a container or bag clearly labeled ldquoDo not userdquo and separated from viable vaccines to prevent inadvertent use Expired vaccinemust be returned to the centralized distributor within six months of expiration
Goal of this question Ensure there is no expired vaccine in any storage unit
Helpful information bull Sites can prevent their stock from expiring by rotating vaccines every week andor when a new shipment arrives Longer-dated vaccines are stored towards the back of the unit and shorter-dated vaccines are up front
bull Pay attention to vaccines that expire within the next three months Consider transferring vaccine that will expire soon to another MnVFC-enrolled site that will use the vaccine preferably a site close by It is the transferring sitersquos responsibility to arrange the transfer of the vaccine Be sure to complete the MDH Vaccine Transfer Record form and send it to MDH If they are having difficulty finding a location to accept vaccine contact MDH
bull This is a great opportunity to educate sites about the MDH Nonviable Vaccine Form and the process for returning vaccine The VFC program does get some credit for taxes and fees on vaccine that is returned to the distribution center
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MDH Nonviable Vaccine Form and MDH Vaccine Transfer Record on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfcformshtml)
IPI Advisor Manual | February 2017 Page 45
The 2017 MnVFC Site Visit Paperwork Chapter 4
- -
-
Question 555 Storage amp Handling Site Wide Back up Thermometer
Question 55 Does the provider have a readily available back-up thermometer with a current and valid certificate ofcalibration testing
Note to Reviewer ldquoReadily availablerdquo means that the thermometer is available to perform twice-a-day monitoring for a unit asrequired CDC recommends that the back-up thermometer be maintained on site
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have a readily available back-up thermometer with a current and valid certificate of calibration testing Toprevent the certificates of calibration testing of the primary and back-up thermometers from expiring at the same time the date of calibration testing (or issue date) of the back-up thermometer should be different from the date of calibration testing (or issue date) of the primary thermometer As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meetsVFC program requirements
Goal of this question Ensure sites have one calibrated back-up thermometer onsite that is readily available in the event that the temperature monitoring device in unit fails transportation of vaccine is needed or there are other unexpected circumstances
Helpful information bull As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meets VFC Program requirements
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 56 5 Storage amp Handling Site Wide Preparation of Vaccine
Question 56 When does this provider prepare vaccine for administration to the patient
Note to Reviewer For mass vaccination clinics if one type of vaccine is offered providers may pre-draw up to 10 doses Ifusing pre-filled syringes pre-drawing also means activating the syringe by removing the needle guard orattaching a needle
Answers (Choose all that
apply)
Prepare dose immediately before administration Pre-draw doses for upcoming patients (in a regular clinicpractice) [O] Pre-draw up to 10 doses (in a mass-vaccination clinic) Pre-draw more than 10 doses (in a mass-vaccination clinic) [O] Other [O]
Review CDC Recommendation
CDC recommends preparing vaccines immediately prior to administration in order to assure viability of vaccine and prevent vaccinewastage Vaccines that are not administered immediately are at risk of exposure to temperatures outside of the required rangewhich can affect vaccine viability and ultimately can leave children unprotected against vaccine-preventable diseases
Goal of this question Discuss proper timing and preparation of vaccine(s) for administration These are recommendations not requirements
Helpful information bull Educate staff on the importance of preparing vaccine immediately before administration Pre-drawing of vaccines may lead to concerns related to vaccine viability potency sterility and wastage
Page 46 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 6 Inventory Question 61
6 Inventory Inventory Comparison
Question 61 Visually inspect storage units to determine if existing supply of vaccines proportionately mirrorspopulations served Choose the most accurate statement below
Note to Reviewer bull CDC recommends that providers maintain a four-week supply of inventory bull For this question do not take into account vaccine types that the provider does not order Here simply
make sure that overall the vaccines in the providerrsquos storage units are available in sufficient amounts toserve their patient population
Answers (Choose one)
The current vaccine inventory proportionately reflects the populations identified Only public stock is insufficient [X] Only private stock is insufficient [X] Both public and private stock are insufficient [X] Site uses the replacement method but does not appear to have enough vaccine for their population [X] Other [X]
Review CDC Requirement
VFC providers must order and stock routine vaccines in accordance with their patient population in order to prevent missedvaccination opportunities Having sufficient amounts of all stocks prevents the inadvertent use of VFC vaccines for non-VFC-eligiblepatients and vice versa
Goal of this question Assess whether the site is ordering appropriate quantities of vaccine for the population they serve at their site
Helpful information bull If the site sees 30 percent private-pay patients and 70 percent VFC the stock in their storage units should reflect that proportion If you donrsquot know you can ask the site about their population
bull This is meant to be a general assessment so in a big site if they have only a small amount of vaccine that may indicate an issue with vaccine management
bull CDC recommends smaller more frequent orders (ie monthly) rather than large orders to minimize the amount of vaccine loss if an incident occurs during shipment or in the storage unit Sites should not order more frequently than once a month
bull Sites using the replacement method will only have one stock but it should appear to be large enough for their population
bull Only assess the vaccine types that the site currently stocks in their unit We know there are sites that do not offer all ACIP-recommended vaccines for various reasons That issue will be addressed in question 62
IPI Advisor Manual | February 2017 Page 47
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 626 Inventory ACIP Recommended Vaccines
Question 62 Review providerrsquos current inventory to answer the questions below
A Does the provider offer all routine ACIP-recommendedvaccines for their patient population
Yes (Skip to question C) No [X] Offers all except varicella because direct ship ofvaccine is unavailable from manufacturer
B Which routine vaccines are NOT being offered DTaP Hepatitis A Hepatitis B HIB HPV Influenza Meningococcal
MMR Pneumococcal Polio Rotavirus TdapTd Varicella
C According to Immunization Program Policy does theprovider make accessible all non-routine ACIP-recommended vaccines for those VFC patients whomeet the criteria for receiving them
Yes (Skip to question 63) No [X]
D Which non-routine vaccines are NOT being offered Pneumococcal polysaccharide vaccine (PPSV23) Meningococcal Group B (MenB) Other
Review CDC Requirement
VFC providers agree to comply with immunization schedules dosages and contraindications that are established by the Advisory Committee on Immunization Practices (ACIP) for the vaccines identified and agreed upon in the Provider Agreement UNLESS bull In the VFC providers medical judgment and in accordance with accepted medical practice the VFC provider deems such
compliance to be medically inappropriate for the child bull The particular requirements contradict state law including laws pertaining to religious and other exemptions The VFC program entitles children to the following vaccines DTaP Hepatitis A Hepatitis B HIB HPV Influenza MeningococcalMMR Pneumococcal Polio Rotavirus TdapTd and Varicella VFC providers are also required to ensure that VFC-eligible children have access to non-routine vaccines as needed
Goal of this question Assess if the site is offering all the ACIP-recommended vaccines for the population they serve and these vaccines are in stock on the day of the visit It is important that every MnVFC-eligible child that comes to a providerrsquos office for an immunization is vaccinated
Helpful information bull The Advisory Committee on Immunization Practices (ACIP) is a group of medical and public health experts that develops recommendations on how to use vaccines to control diseases in the United States
bull Specialty providers are not required to offer all routine vaccines but should provide the vaccines appropriate for their population
bull If the site does not offer all routine ACIP-recommended vaccines appropriate for their population check the ldquoNordquo box in Part A then check the appropriate box(es) in Part B for any vaccines not offered Please contact MDH as this situation offers us the opportunity to provide education to the site
bull For non-routine vaccines they must either be in stock or the site must have an alternative protocol in the routine management plan that ensures these children have access when applicable
Resources bull IAC Diseases and Vaccines (wwwimmunizeorgvaccines) bull CDC Advisory Committee on Immunization Practices (ACIP) (wwwcdcgovvaccinesacipindexhtml)
Page 48 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 636 Inventory Separation of Stock
Question 63 Observe how the provider differentiates stock in each storage unit to answer the questions below
A Is it clear which vaccines belong to public stock andwhich belong to private stock
Yes No [X] Not applicable replacement site
B Is it clear which vaccines belong to VFC stock andwhich belong to UUAV stock
Yes No [X] Not applicable replacement site Not applicable not UUAV-enrolled site
Review CDC Requirement
In order to ensure that VFC vaccines are only administered to VFC-eligible children VFC providers that serve both VFC and non-VFCshyeligible children must maintain their vaccine inventories in such a way that they can clearly differentiate public stock from privatestock as well as VFC from other public stock
Goal of this question Assess whether the site can distinguish between MnVFC vaccine and private vaccine If they participate in the Uninsured and Underinsured Adult Vaccine (UUAV) program they should also be able to distinguish between MnVFC stock and UUAV stock Some sites use labels bins boxes etc to differentiate their stock If it is not clear how the site differentiates their stock discuss vaccine management with the staff For follow-up call MDH to discuss doing a follow-up site visit
Sites using the replacement method will not have separate stocksmdashthis is an approved alternative method for keeping track of vaccine
Resource bull Section 10 of the MnVFC Policy and Procedure Manual
IPI Advisor Manual | February 2017 Page 49
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
MnVFC Site Visit Storage and Handling Per Unit Answer Sheet 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet MnVFC PIN ___________________
Question number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
Temperature Monitoring Device Questions Questions 43 47 must be answered separately for the freezer and refrigerator if the unit is a combo Be sure to document responses in the appropriate column
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
All the questions on the Site Visit Storage amp Handling Per Unit Answer Sheet have been discussed previously in section 4 of this manual Use this sheet to record information about all the units at the site visit You will need one sheet for each unit If it is a combination unit (either pharmaceutical or household) you can record both sections on one sheet If they have stand-alone units use one sheet for each unit Do not enter the answers to the questions in section 4 of the questionnaire
If you need more information about any of the questions refer back to the main questionnairemdashthe complete question additional guidance including notes to the reviewer and the CDC requirements are there Also if the site is not meeting the requirement you will go back to the questionnaire to complete the ldquoActions if Non-compliantrdquo section including the root cause analysis and follow-up sections
When you have completed the assessment of all the storage units remember to go back to the questionnaire to complete sections 5 and 6
Page 50 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
ndash
ndash
MnVFC Provider Follow-up PlanThe goal of the Provider Follow-up Plan is to communicate with the site all of the VFC requirements any unmet requirements found during your site visit and the timeline for completing the required action The left hand column is a box to check for ldquoUnmetrdquo requirements
Helpful information bull The form can be used to review what the site is doing well and what they need to work on
bull For requirements that have specific documentation that needs to be sent to you use the notes section
2017 MnVFC Provider Follow-up Plan Site _______________________________________________ MnVFC PIN ____________ Date of Visit ___________
Thank you for participating in this MnVFC compliance site visit Please review this visit summary including follow-up actions and timelines for completion Unmet MnVFC requirements and recommendations have a checked box next to them The goal of this plan is to support you with successfully implementing the program and improving access to vaccines for VFC-eligible children
Unmet Question VFC Requirements Section 1 Changes to Key Staff
Q12 Change in the Medical Director Immunization Manager Vaccine Coordinator or back-upKey Staff must be communicated to the immunization program by emailing healthmnvfcstatemnus Changes Notes
Q12 Key staff must complete the annual training on VFC program requirements and print theAnnual Training certificate of completion Documentation Required Action
Staff that have not completed the MnVFC online training must complete it and send acopy of the certificate to the reviewer Training can be found on the MnVFC website (wwwhealthstatemnusvfc) Due date 1 month
Notes
Unmet Question VFC Requirements Section 2 Eligibility
Q21 Provider staff must possess a working knowledge of all VFC eligibility criteria and use thoseVFC Eligibility criteria to screen children prior to administering VFC vaccines
Categories Notes
bull This form provides documentation needed for follow-up actions when you send your thank you email
The second to last page of the Provider Follow-up Plan has a summary of the MnVFC program recommendations These are to remind the site about best practices they may want to improve upon even though they are not yet requirements of the program For example you could discuss the recommendation about storage units if they currently have a combination household unit and are using both sections
The last section is for your signature and the person you met with In most sites it will be the immunization manager or vaccine coordinator who signs the form unless the medical director attended the site visit You keep the original copy and the site will need to keep a copy for themselves
To be completed by the site visit reviewer
I acknowledge that a VFC site visit was performed on __________________ (visit date) The follow-up plan which includes a list of all current VFC program requirements and recommendations assessed during the visit and any required follow-up actions was provided at the end of the visit
Site visit reviewer
Phone
Reviewer Signature Date
To be completed by the provider
I acknowledge that our practice took part in the VFC site visit noted above I understand the findings of the visit and any required actions that must be taken by our office in order to meet VFC program requirements
Medical Director (or designee) Name Title
Medical Director (or designee) Signature Date
IPI Advisor Manual | February 2017 Page 51
The 2017 MnVFC Site Visit Paperwork Chapter 4
After the Site Visit Send a thank you email highlighting the unmet requirements documents you need from the site to resolve the issue(s) and the date you need them Make sure to include the link to the Site Visit Survey (httpssurveyvovicicomseashxs=56206EE334CE0B14)
Please refer to Chapter 3 for more information about future follow-up required after the visit including forms and documentation
Resource bull Sample Thank You letter on IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml)
Chapter 5
IPI Advisor Resource List MnVFC Program 651-201-5522
MnVFC wwwhealthstatemnusvfc
bull Separate Stock and Replacement Method Policies and Procedures Manuals bull Online trainings bull MnVFC Announcements sign up to receive them via email bull Ordering MDH vaccine bull MnVFC forms Screening forms Reporting forms Others MDH Nonviable Vaccine Form MDH Vaccine Transfer Record and Vaccine Borrowing Report
bull MnVFC promotional materials bull Immunization Billing Guidance for MnVFC and Immunization Billing Guidance for MnVFC Replacement Sites Immunization Practices Improvement Program (IPI) wwwhealthstatemnusdivsidepcimmunizeipi
bull IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml) bull IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml) IPI Resource Folder Contents (wwwhealthstatemnusdivsidepcimmunizeipiipifolderpdf)
Minnesota Immunization Information Connection (MIIC) wwwhealthstatemnusmiic
bull MIIC regions and regional coordinators
Clinical Practice MDH Immunization Program wwwhealthstatemnusimmunize
Got Your Shots News wwwhealthstatemnusdivsidepcnewslettersgys
MDH Immunization Information for Health Care Providers wwwhealthstatemnusdivsidepcimmunizehcp
bull Got Your Shots A Providers Guide to Immunization in Minnesota bull Vaccine protocols bull Forms for tracking patient immunizations bull Immunization schedules for Health Care Providers Immunization Action Coalition (IAC) wwwimmunizeorg
bull Ask the Experts bull VISs (Vaccine Information Statements and translations) bull Administration screening questions bull Medical management of vaccine reactions bull Order form for Californiarsquos Immunization Technique DVD Best Practices with Infants Children and Adults
Page 52 IPI Advisor Manual| February 2017
IPI Advisor Resource List Chapter 5
CDC ldquoPink Bookrdquo wwwcdcgovvaccinespubspinkbookindexhtml
CDC Advisory Committee on Immunization Practices (ACIP) wwwcdcgovvaccinesacip
CDC Vaccines and Immunizations wwwcdcgovvaccines
VAERS reporting httpvaershhsgovindex
Storage and Handling Got Your Shots Providers Guide ndash Managing Vaccine wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml
MnVFC Guide to Temperature Monitoring Devices wwwhealthstatemnusvfc
MDH Clinicianrsquos Vaccine Mishap Checklist wwwhealthstatemnusdivsidepcimmunizeipivaxchklstpdf
MDH Vaccine Storage Guide wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml
CDC Vaccine Storage and Handling Toolkit wwwcdcgovvaccinesrecsstoragetoolkit
You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Vaccine manufacturer phone numbers wwwcdcgovvaccinespubspinkbookdownloadsappendicesFcontact-info-manufactpdf
IAC Checklist for Safe Vaccine Handling and Storage wwwimmunizeorgcatgdp3035pdf
IAC Donrsquot Be Guilty of These Errors in Vaccine Storage and Handling wwwimmunizeorgcatgdp3036pdf
Additional Resources Print materials from MDH ndash order forms wwwhealthstatemnusdivsidepcimmunizeordermathtml
Vaccine Education Center ndash Childrenrsquos Hospital of Philadelphia wwwchopeduservicevaccine-education-centerhomehtml
California Department of Public Health ndash Interactive training on vaccine administration and storage and handling handout on transporting vaccine and how to package wwwezizorg
IPI Advisor Manual | February 2017 Page 53
IPI Advisor Resource List Chapter 5
CDC vaccine price list wwwcdcgovvaccinesprogramsvfcawardeesvaccine-managementprice-listindexhtml
Vaccine Information Statements (VIS) wwwcdcgovvaccineshcpvisindexhtml
CEU Opportunities CDC Immunization Education and Training wwwcdcgovvaccinesedindexhtml
Immunization You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Page 54 IPI Advisor Manual| February 2017
- Introduction
-
- Welcome to the Immunization Practice Improvement (IPI) Program
- Contact Information
-
- Chapter 1
- Requirements to Participate in the MnVFC Program
- Vaccines for Children Program
- Chapter 2
- Reimbursement for MnVFC Visits
- Types of Visits
- Your MnVFC Clinical CoordinatorPlanner
- New IPI Advisor Training Requirements
- Your Role as an IPI Advisor
- Reasons MDH Would Do All or Part of a Visit
- Chapter 3
- Future follow-up
- Conducting the Visit
- Preparing for the Visit
- Information for the Visit
- Site Visit Checklist
- Scheduling the Visit
- Chapter 4
- After the Site Visit
- MnVFC Provider Follow-up Plan
- MnVFC Site Visit Storage and Handling Per Unit Answer Sheet
- Section 6 Inventory
- Section 5 Storage amp Handling Site-Wide
- Section 4 Storage amp Handling Per Unit
- Section 3 Documentation
- Section 2 Eligibility
- Section 1 Provider Details
- The Site Visit Reviewer Legend
- MnVFC Site Visit Questionnaire
- Required Paperwork for Site Visits
- Chapter 5
-
Page 36 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 45
Goal of this question Ensure the temperature monitoring device is properly calibrated The certificate of calibration testing means that the device has been tested and it is accurately measuring temperatures within established testing limits The certificate of calibration ensures that the device meets all the required components
Helpful information bull The provider is always responsible for having a current certificate of calibration (or copy) on-site
bull To be considered ldquovalidrdquo a certificate of calibration must contain these required elements Modeldevice name or number Serial number
4 Storage amp Handling Per Unit Certificate of Calibration Testing
Review CDC Requirement
Certificates of calibration testing provide confidence that the temperature monitoring device is measuring temperaturesaccurately All units storing VFC vaccines must have a calibrated temperature monitoring device with a current and valid certificateof calibration testing All certificates must contain modeldevice name or number serial number date of calibration testing (report or issue date) and Instrument Passed testingInstrument in Tolerance (Recommended uncertainty = +-05ordm C (+-1ordm F))
Question 45
Note to Reviewer
A
B
C
D
E
Review the certificate of calibration testing for the temperature monitoring device in this section of the storage unit and answer the questions below
bull How to determine certificate of calibration testing expiration date 1) Identify the certificate issuecalibration date 2) Apply the Immunization Program-required frequency for calibration testing Example If the
issuecalibration date is 12312013 and Immunization Program policy requires testing every twoyears the expiration date is 12312015
bull Certificates must include all of the below bull ModelDevice Name or Number bull Serial Number bull Date of Calibration Testing (Report or Issue Date) bull Instrument Passed testing (Instrument in Tolerance)
Is there a certificate of calibration testing for the temperature monitoring Yes device in this section of the storage unit No [X]
What is the date of calibration for the temperature monitoring device in this section of the storage unit
What is the certificatersquos date of expiration based on ImmunizationProgram policy (See note to reviewer to determine expiration date) [X] Follow-up is required if
certificate is expired
Does the certificate contain all the necessary items listed in the Note to Yes Reviewer No [X]
Who is responsible for supplying the current and valid certificate of Provider calibration for this temperature monitoring device
Date of calibration testing (report or issue date) Note If there is no expiration date the certificate expires 2 years from the date of calibration Whether the instrument passed or failed testing (or instrument in tolerancenot in tolerance)
bull Recommended element Documented uncertainty of +- 1degF [05degC]
If these elements are present the certificate is considered valid If the certificate contains information about the recommended element or the entity that issued the certificate that is helpful but not required
To determine if a certificate of calibration testing was issued by an appropriate entity check to see if the certificate indicates one or more of these items (this is the wording used to help sites evaluate if their calibration is accurate but is not required on the certificate itself to be considered valid)
bull Conforms to ISO 17025 bull Performed by an ILACMRA Signatory body accredited laboratory You can review this list of the ILAC MRA and Signatories (httpilacorgilac-mra-and-signatories)
bull Traceable to the standards maintained by NIST bull Meets specifications and testing requirements for the American Society for Testing and Materials (ASTM) Standard E2877 tolerance Class F (le 05 degC) or better
bull Includes reference to another acceptable accuracy validation method such as comparison to other traceable reference standards or tests at thermometric fixed points
Note CDC recommends that certifications be issued for the entire monitoring unit (detachable probe data logger etc) and not individual certificates for each component
IPI Advisor Manual | February 2017 Page 37
The 2017 MnVFC Site Visit Paperwork Chapter 4
For 45 E the provider is always responsible for supplying the current and valid certificate of calibration for a temperature monitoring device
bull Tip If the temperature monitoring device has a sticker on the back with the calibration date the site can usually call the company who calibrated the device and get a copy of the certificate if they donrsquot have one
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 46 4 Storage amp Handling Per Unit Probe Placement
Question 46 Is the probe properly placed in this section of the storage unit
Note to Reviewer ldquoProperlyrdquo means that the probe in a commercial or household unit is placed in a central area of the unitdirectly with the vaccines Probes should not be placed in the doors near or against the walls close to vents or on the floor of the unit The only allowable exemption related to this requirement is for providerswho have pharmaceutical storage units (built for vaccine storage) that have either (1) a built-intemperature monitoring device OR (2) a dedicated port for the probe that dictates the placement of theprobe
Answers (Choose one)
Yes No [X]
Review CDC Requirement
The probe must be placed in a central area of the section of the storage unit directly with the vaccines in order to properly measurevaccine temperature The probe should not be placed in the door near or against the walls close to vents or on the floor of theunit For pharmaceutical units with a built-in temperature monitoring device or a dedicated port for a probe that is not in thecenter of the section of the storage unit consult your Immunization Program for guidance on placement
Goal of this question Make sure the temperature monitoring device is in the best location to accurately measure the temperature of the vaccines stored in the unit
Helpful information bull The probe of the temperature monitoring device should be placed directly with the vaccines in the middle of the unit The ONLY allowable exception is for pharmaceutical storage units that have either a built-in thermometer or a dedicated port for the probe that indicates placement of the probe
bull Temperatures can vary within the unit especially household units bull Call MDH at 651-201-5522 if you have questions
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Guide (wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml)
Page 38 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 474 Storage amp Handling Per Unit Temperature Documentation
Question 47 Review the temperature documentation over the past three months for this section of the storage unit todetermine whether the provider has a process in place for properly documenting temperatures twice aday Answer the questions below
A Are there two temperature readings recorded for this section of the storage unit per day
Yes No [X]
B Is there a time date and name (or initials) recorded for each reading Yes No [X]
C What is the current temperature and minmax temperatures (if available) inthis section of the storage unit Use the reviewerrsquos thermometer if the providerrsquos temperature monitoringdevice does not have a current valid certificate of calibration testing or the probe is not properly placed in this section of the storage unit
Current Temperature Minimum Temperature Maximum Temperature Fahrenheit Celsius
D Based on your review of the providerrsquos recent temperature documentationincluding the current temperature is this section of the storage unitmaintaining appropriate temperatures
Yes No [X] Not enough information [X]
Review CDC Requirement
Vaccines must be stored under appropriate temperatures as described in the package inserts at all times Acceptable temperature ranges vary by vaccine type and the range is 36deg F and 46deg F (2deg C and 8deg C) and for frozen vaccines the range is -58deg F and +5deg F (shy50deg C and -15deg C) Exposure to temperatures outside of those included in the package inserts could affect vaccine viability andultimately could leave children unprotected against vaccine-preventable diseases In order to maintain awareness of storage unittemperatures and ensure that vaccines are being stored at appropriate temperatures at all times VFC providers are required to monitor and document temperatures for all vaccine storage units at least twice a day Temperature documentation must contain (1) at least two temperature readings per day (2) the time and date of each reading and (3) the name (or initials) of the personwho assessed and recorded the readings CDC also recommends that VFC providers record the minimum and maximumtemperatures of each unit once each workday (preferably in the morning)
Goal of this question Ensure the temperature is being monitored twice daily is within the required range and documented correctly Use your thermometer to check the temperature if the sitersquos temperature monitoring devicersquos probe is not properly placed or there is not a current certificate of calibration Place your thermometer in the unit at the beginning of the visit to allow sufficient time to reach an accurate temperature The purpose of using your thermometer is to ensure the vaccine is being stored at the proper temperature not to ldquovalidaterdquo their reading
Question 47 D is an assessment question based on information you have learned during your visit You might answer ldquonot enough informationrdquo if the unit is new and they donrsquot have at least three months of data or if the unit is only used as overflow and they are inconsistent with temperature monitoring Mark ldquoNordquo if you have reason to believe the storage unit is not maintaining temperatures properly
Helpful information bull All sites must document temperatures twice a day every day the site is open even if they have a data logger or continuous monitoring system
bull Sites can document the information electronically with some continuous monitoring systems as long as it can show what the current temp is the date time and initials of the person checking ndash this needs to be someone at the site ndash not checking remotely or centrally for a large site or system The site must be able to produce these records during their site visit Reviewing these files can be a challenge due to large volumes and lots of paper
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Temperature Logs on Managing Vaccine (wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml)
IPI Advisor Manual | February 2017 Page 39
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 484 Storage amp Handling Per Unit Temperature Excursions
Question 48 In the event that a temperature excursion(s) occurred in this unit within the last three months requestand review documentation of actions taken to determine whether the provider has a process for properlyaddressing excursions Answer the questions below
A Were vaccines in this unit exposed to out-of-range temperatures in the lastthree months (including today)
Yes No (If no skip to question 49)
B Did the provider quarantine and label vaccines as ldquoDo not userdquo Yes No [X]
C Did the provider place vaccine in a unit where it can be stored under properconditions if applicable
Yes No [X]
D Did the provider contact the Immunization Program to report theexcursion
Yes No [X]
E Was the manufacturer contacted for documentation supporting theusability of the vaccine
Yes No [X]
Review CDC Requirement
The provider must document all excursions and actions taken including the following (1) Quarantine and label vaccines as ldquoDO NOTUSErdquo (2) Place vaccines in a unit where they can be stored under proper conditions (3) Contact the Immunization Program to report an excursion and (4) Contact the vaccine manufacturer to obtain documentation supporting the usability of the vaccine
Goal of this question Address any out-of-range temperatures (temperature excursions) identified in reviewing the last three months of temperature logs or during the site visit If there were any out-of-range temperatures did the site respond appropriately to the situation This is a great opportunity to discuss what to do in the event of an excursion The Clinicians Storage and Handling Mishap Checklist is in the IPI Site Visit information folder and is a good review of the process
Helpful information bull Sites need to know that an excursion does not automatically mean that exposed vaccines are non-viable or unusable Exposed vaccines must be quarantined (marked ldquoDo Not Userdquo) and stored under proper conditions until they have received information from vaccine manufacturers regarding the viability of the vaccine
bull Sites must inform MDH when an excursion occurs
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Clinicians Storage and Handling Mishap Checklist (wwwhealthstatemnusdivsidepcimmunize ipivaxchklstpdf)
Page 40 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 49
Goal of this question Ensure proper placement of vaccines in the storage unit
Note These are all recommendations (best practices) not requirements
Helpful information bull Store vaccine in the middle of the compartment two to three inches away from the coils walls floor and cold air vent The temperature near the floor and walls of the unit differs from that in the middle of the compartment and the cold air vent can freeze refrigerated vaccines
4 Storage amp Handling Per Unit Vaccine Placement
Question 49 Look inside the unit to answer the questions below
A Are vaccines placed in the middle of the unit with space between vaccinesand the sideback of the unit to allow cold air to circulate
Yes No [O]
B Are vaccines stored in their original packages Yes No [O]
C Are there water bottles (for refrigerators) or frozen water bottles (forfreezers) in the unit
Yes No [O]
D Are vaccines store in the doors vegetable bins under or near cooling ventsor on the floor of the unit
Yes [O] No
E Is food being stored in the unit Yes [O] No
Review CDC Recommendation
Vaccines should be stored in their original manufacturer (or CDC centralized distributor) packaging They should be placed in the middle of the unit with space between the vaccines and the sideback of the unit to allow cold air to circulate Vaccines SHOULD NOT be stored in the doors vegetable bins or floor of the unit or under or near cooling vents and there should not be any food inthe unit Water bottles (for refrigerators) or frozen water bottles (for freezers) should be placed throughout each storage unit inorder to (1) stabilize or extend temperatures during a power outage and (2) to serve as physical blocks preventing the placementof vaccines in areas of the unit that are at higher risk for temperature excursions (such as in doors vegetable bins floor ornearunder cooling vents)
bull Vaccines should be kept in their original packaging to Protect them from light Help prevent medication errors by making labels easier to read Provide a moisture barrier that serves as insulation in case of an out-of-range temperature power outage door left open or mechanical failure Simplify managing vaccine inventory
bull Store water bottles in the doors on the floor and near the cold air vent in the refrigerator and frozen water bottles in the freezer to help maintain a stable temperature if there is a power failure and when the door is opened frequently Too many water bottles in the door can prevent the door from closing tightly Mark water bottles ldquoDo Not Drinkrdquo
bull Do not store vaccine in the door or drawers of the refrigerator or freezer Vegetable bins and crisper drawers should be removed from refrigerators or used to store other medical supplies or water bottles
bull If vaccine is stored in a household combination refrigeratorfreezer The top shelf should not be used for storing vaccine because the cold air vent blowing from the freezer will freeze vaccine located there If you must use the top shelf of this type of unit place water bottles underneath the cold air vent to prevent vaccine from being stored there It is recommended that only the refrigerator be used for vaccine storage and a separate stand-alone freezer be used to store frozen vaccine
bull Must not store food or beverages in the refrigerator or freezer because frequent opening of doors can lead to temperature variations that may affect vaccine viability There is also a risk of contaminating vaccines
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Guide (wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml) bull Vaccine Storage Tip Sheet on IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml)
IPI Advisor Manual | February 2017 Page 41
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 4104 Storage amp Handling Per Unit Disconnection from Power Source
Question 410 Ask the provider to demonstrate what measures are taken to ensure that vaccine storage units are notaccidentally physically disconnected from the power supply Which of the following describes the measure(s) taken on this unit
Note to Reviewer bull Large hospitals and healthcare systems may not have the ability to demonstrate labels on plugs or circuitbreakers In such cases verify that the practice has a comprehensive policy and standard operatingprocedures in place to prevent the vaccine storage unit from being physically disconnected from thepower supply
bull While back-up generators may ensure power to the overall facility this question ONLY addresses thevaccine storage unit being accidentally disconnected from the power source either through the plug orthe circuit breaker
Answers A ldquoDo not disconnectrdquo labels on the plug (Choose all that B ldquoWarningrdquo label on the circuit breaker box
apply) C Hard-wired (ie built-in) and has a ldquoDo not disconnectrdquo label on thecircuit breaker box D Hospital or large health care system with a comprehensive written policyand standard operating procedures detailing measures taken to preventvaccine storage units from being accidentally disconnected from the powersupply E No acceptable measures for preventing accidental disconnection frompower supply [X]
[X] The response is non-compliant if only A only B or E is selected
Review CDC Requirement
VFC providers must take steps to protect the power source for all vaccine storage equipment by means of having clear warninglabels on both the plug and the circuit breaker associated with all vaccine storage units Large hospitals and healthcare systems canmeet this requirement by demonstrating that they have comprehensive policies and standard operating procedures to preventvaccine storage units from being physically disconnected from the power supply
Goal of this question Decrease the chance that a vaccine storage unit will be accidently unplugged or power will be turned off while vaccine is in the unit This question addresses only what measures the site has taken to ensure the storage unit is not physically disconnected from its power source
If the site uses labels on the plugs and circuit breakers perform a visual inspection to assess whether the way the stickers are positioned make it clear and obvious to anyone that these units are not to be disconnected
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Do Not Unplug and Warning stickers are included in the folder or available to order on the For
Professionals Order Form (wwwhealthstatemnusdivsidepcimmunizeordermathtml)
Note Once you have completed the 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet for each unit return to the questionnaire to complete sections 5 and 6
Page 42 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
- -
Section 5 Storage amp Handling Site-Wide Question 51
5 Storage amp Handling Site Wide Discussion of Cost amp Quantity of Vaccine
Question 51 Have a discussion with the provider about the cost and quantity of VFC vaccines they are responsible for annually Address the points listed in the note to reviewer below
Note to Reviewer bull Vaccine Shipped (Required) Share the cost of VFC vaccines shipped to the provider in the last calendaryear to make sure the provider understands the contribution made by the VFC Program to their practiceFor new providers who do not have ldquocalendar yearrdquo data share either the actual cost of their currentinventory or use the cost of 10 VFC doses of each of the ACIP-recommended vaccines (approximately $7000) to help estimate their annual cost
bull Storage amp Handling (Required) Make sure the provider understands the cost of vaccines for which they are responsible when they make decisions about purchasing recommended vaccine storage and temperature monitoring equipment
Answer I have discussed with the provider the cost and quantity of vaccines ordered in the previous calendar year
Goal of this question Inform sites of the quantity and value of vaccines that they receive as part of the MnVFC program Providers often donrsquot realize the value of the vaccine in their unit This information is included on your clinic list and on the one page site-specific information
Helpful information bull This discussion must occur and the box on the questionnaire must be checked bull If there isnrsquot actual vaccine value information available tell the site that one vaccine order that includes a box of each of the ACIP recommended vaccines costs approximately $7000
bull MDH may not have specific information for individual sites if they receive vaccine from a central warehouse or pharmacy For those sites MDH will give you numbers for the whole system so you can discuss system wide data as appropriate If individual site information is also included it is usually just varicella-containing vaccines that must be shipped directly to the site
Question 52
5 Storage amp Handling Site Wide Dorm Style Units
Question 52 Determine whether the provider has any dorm-style units on site and answer the questions below
Note to Reviewer A dormitory-style refrigerator is a unit that has both refrigerator and freezer compartments behind a singleexterior door Dorm-style units also have an evaporator plate (cooling coil) which is usually located insidean icemaker compartment (freezer) within the refrigerator
A Does the provider have any dorm-style units that are used at any time tostore vaccines
Yes [X] No (Skip to question 53)
B Does the provider have sufficient space in existing compliant vaccinestorage units to store all vaccines without use of the dorm-style unit at any time
Yes No [X]
Review CDC Requirement
Dorm- and bar-style units are prohibited for vaccine storage Vaccines stored in dorm-style units are considered non-viable and must be returned to the centralized distributor CDC recommends the following vaccine storage unit types (in order of preference)pharmaceutical grade stand-alone or combination units (preferred) householdcommercial stand-alone unitshouseholdcommercial combination units using the refrigerator section only
Goal of this question Ensure no vaccine is stored in dorm-style units even for short periods of time Encourage them to label any units ldquoNo Vaccine Storage Allowedrdquo Vaccine stored in these units is considered non-viable If a site is using a dorm-style unit call the MnVFC program (651-201-5522)
Resource Section 8 in the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 43
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 535 Storage amp Handling Site Wide Storage Unit Space Availability
Question 53 Does the provider have sufficient room across storage units to store current stock as well as anyadditional stock acquired during peak season without overcrowding
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have sufficient storage space to accommodate vaccine stock at the busiest time of year without overcrowding
Goal of this question Ensure that sites have sufficient space in their units to maintain vaccines at the busiest time of year Overcrowding of vaccine limits air circulation and affects the unitrsquos ability to maintain stable temperatures
Helpful information bull Look for signs of overcrowding such as vaccines that are pushed up against the wall bins that are overflowing or storage units that are full during non-peak seasons
Discuss immediate actions if the unit is overcrowded Move some of their vaccines order less vaccine more frequently (once per month preferably) andor purchase another storage unit for overflow
Resource bull Section 8 MnVFC Policy and Procedure Manual
Page 44 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 545 Storage amp Handling Site Wide Expired Vaccines
Question 54 Look in each unit Are there expired vaccines in any of the vaccine storage units at this site
Answers (Choose one)
Yes [X] No
Review CDC Requirement
Vaccines should be rotated weekly and when a new shipment comes in so that longer-dated vaccines are stored behind shorter-dated vaccines If vaccines expire they can no longer be stored in the same storage unit with viable vaccines They must be placedin a container or bag clearly labeled ldquoDo not userdquo and separated from viable vaccines to prevent inadvertent use Expired vaccinemust be returned to the centralized distributor within six months of expiration
Goal of this question Ensure there is no expired vaccine in any storage unit
Helpful information bull Sites can prevent their stock from expiring by rotating vaccines every week andor when a new shipment arrives Longer-dated vaccines are stored towards the back of the unit and shorter-dated vaccines are up front
bull Pay attention to vaccines that expire within the next three months Consider transferring vaccine that will expire soon to another MnVFC-enrolled site that will use the vaccine preferably a site close by It is the transferring sitersquos responsibility to arrange the transfer of the vaccine Be sure to complete the MDH Vaccine Transfer Record form and send it to MDH If they are having difficulty finding a location to accept vaccine contact MDH
bull This is a great opportunity to educate sites about the MDH Nonviable Vaccine Form and the process for returning vaccine The VFC program does get some credit for taxes and fees on vaccine that is returned to the distribution center
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MDH Nonviable Vaccine Form and MDH Vaccine Transfer Record on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfcformshtml)
IPI Advisor Manual | February 2017 Page 45
The 2017 MnVFC Site Visit Paperwork Chapter 4
- -
-
Question 555 Storage amp Handling Site Wide Back up Thermometer
Question 55 Does the provider have a readily available back-up thermometer with a current and valid certificate ofcalibration testing
Note to Reviewer ldquoReadily availablerdquo means that the thermometer is available to perform twice-a-day monitoring for a unit asrequired CDC recommends that the back-up thermometer be maintained on site
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have a readily available back-up thermometer with a current and valid certificate of calibration testing Toprevent the certificates of calibration testing of the primary and back-up thermometers from expiring at the same time the date of calibration testing (or issue date) of the back-up thermometer should be different from the date of calibration testing (or issue date) of the primary thermometer As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meetsVFC program requirements
Goal of this question Ensure sites have one calibrated back-up thermometer onsite that is readily available in the event that the temperature monitoring device in unit fails transportation of vaccine is needed or there are other unexpected circumstances
Helpful information bull As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meets VFC Program requirements
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 56 5 Storage amp Handling Site Wide Preparation of Vaccine
Question 56 When does this provider prepare vaccine for administration to the patient
Note to Reviewer For mass vaccination clinics if one type of vaccine is offered providers may pre-draw up to 10 doses Ifusing pre-filled syringes pre-drawing also means activating the syringe by removing the needle guard orattaching a needle
Answers (Choose all that
apply)
Prepare dose immediately before administration Pre-draw doses for upcoming patients (in a regular clinicpractice) [O] Pre-draw up to 10 doses (in a mass-vaccination clinic) Pre-draw more than 10 doses (in a mass-vaccination clinic) [O] Other [O]
Review CDC Recommendation
CDC recommends preparing vaccines immediately prior to administration in order to assure viability of vaccine and prevent vaccinewastage Vaccines that are not administered immediately are at risk of exposure to temperatures outside of the required rangewhich can affect vaccine viability and ultimately can leave children unprotected against vaccine-preventable diseases
Goal of this question Discuss proper timing and preparation of vaccine(s) for administration These are recommendations not requirements
Helpful information bull Educate staff on the importance of preparing vaccine immediately before administration Pre-drawing of vaccines may lead to concerns related to vaccine viability potency sterility and wastage
Page 46 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 6 Inventory Question 61
6 Inventory Inventory Comparison
Question 61 Visually inspect storage units to determine if existing supply of vaccines proportionately mirrorspopulations served Choose the most accurate statement below
Note to Reviewer bull CDC recommends that providers maintain a four-week supply of inventory bull For this question do not take into account vaccine types that the provider does not order Here simply
make sure that overall the vaccines in the providerrsquos storage units are available in sufficient amounts toserve their patient population
Answers (Choose one)
The current vaccine inventory proportionately reflects the populations identified Only public stock is insufficient [X] Only private stock is insufficient [X] Both public and private stock are insufficient [X] Site uses the replacement method but does not appear to have enough vaccine for their population [X] Other [X]
Review CDC Requirement
VFC providers must order and stock routine vaccines in accordance with their patient population in order to prevent missedvaccination opportunities Having sufficient amounts of all stocks prevents the inadvertent use of VFC vaccines for non-VFC-eligiblepatients and vice versa
Goal of this question Assess whether the site is ordering appropriate quantities of vaccine for the population they serve at their site
Helpful information bull If the site sees 30 percent private-pay patients and 70 percent VFC the stock in their storage units should reflect that proportion If you donrsquot know you can ask the site about their population
bull This is meant to be a general assessment so in a big site if they have only a small amount of vaccine that may indicate an issue with vaccine management
bull CDC recommends smaller more frequent orders (ie monthly) rather than large orders to minimize the amount of vaccine loss if an incident occurs during shipment or in the storage unit Sites should not order more frequently than once a month
bull Sites using the replacement method will only have one stock but it should appear to be large enough for their population
bull Only assess the vaccine types that the site currently stocks in their unit We know there are sites that do not offer all ACIP-recommended vaccines for various reasons That issue will be addressed in question 62
IPI Advisor Manual | February 2017 Page 47
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 626 Inventory ACIP Recommended Vaccines
Question 62 Review providerrsquos current inventory to answer the questions below
A Does the provider offer all routine ACIP-recommendedvaccines for their patient population
Yes (Skip to question C) No [X] Offers all except varicella because direct ship ofvaccine is unavailable from manufacturer
B Which routine vaccines are NOT being offered DTaP Hepatitis A Hepatitis B HIB HPV Influenza Meningococcal
MMR Pneumococcal Polio Rotavirus TdapTd Varicella
C According to Immunization Program Policy does theprovider make accessible all non-routine ACIP-recommended vaccines for those VFC patients whomeet the criteria for receiving them
Yes (Skip to question 63) No [X]
D Which non-routine vaccines are NOT being offered Pneumococcal polysaccharide vaccine (PPSV23) Meningococcal Group B (MenB) Other
Review CDC Requirement
VFC providers agree to comply with immunization schedules dosages and contraindications that are established by the Advisory Committee on Immunization Practices (ACIP) for the vaccines identified and agreed upon in the Provider Agreement UNLESS bull In the VFC providers medical judgment and in accordance with accepted medical practice the VFC provider deems such
compliance to be medically inappropriate for the child bull The particular requirements contradict state law including laws pertaining to religious and other exemptions The VFC program entitles children to the following vaccines DTaP Hepatitis A Hepatitis B HIB HPV Influenza MeningococcalMMR Pneumococcal Polio Rotavirus TdapTd and Varicella VFC providers are also required to ensure that VFC-eligible children have access to non-routine vaccines as needed
Goal of this question Assess if the site is offering all the ACIP-recommended vaccines for the population they serve and these vaccines are in stock on the day of the visit It is important that every MnVFC-eligible child that comes to a providerrsquos office for an immunization is vaccinated
Helpful information bull The Advisory Committee on Immunization Practices (ACIP) is a group of medical and public health experts that develops recommendations on how to use vaccines to control diseases in the United States
bull Specialty providers are not required to offer all routine vaccines but should provide the vaccines appropriate for their population
bull If the site does not offer all routine ACIP-recommended vaccines appropriate for their population check the ldquoNordquo box in Part A then check the appropriate box(es) in Part B for any vaccines not offered Please contact MDH as this situation offers us the opportunity to provide education to the site
bull For non-routine vaccines they must either be in stock or the site must have an alternative protocol in the routine management plan that ensures these children have access when applicable
Resources bull IAC Diseases and Vaccines (wwwimmunizeorgvaccines) bull CDC Advisory Committee on Immunization Practices (ACIP) (wwwcdcgovvaccinesacipindexhtml)
Page 48 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 636 Inventory Separation of Stock
Question 63 Observe how the provider differentiates stock in each storage unit to answer the questions below
A Is it clear which vaccines belong to public stock andwhich belong to private stock
Yes No [X] Not applicable replacement site
B Is it clear which vaccines belong to VFC stock andwhich belong to UUAV stock
Yes No [X] Not applicable replacement site Not applicable not UUAV-enrolled site
Review CDC Requirement
In order to ensure that VFC vaccines are only administered to VFC-eligible children VFC providers that serve both VFC and non-VFCshyeligible children must maintain their vaccine inventories in such a way that they can clearly differentiate public stock from privatestock as well as VFC from other public stock
Goal of this question Assess whether the site can distinguish between MnVFC vaccine and private vaccine If they participate in the Uninsured and Underinsured Adult Vaccine (UUAV) program they should also be able to distinguish between MnVFC stock and UUAV stock Some sites use labels bins boxes etc to differentiate their stock If it is not clear how the site differentiates their stock discuss vaccine management with the staff For follow-up call MDH to discuss doing a follow-up site visit
Sites using the replacement method will not have separate stocksmdashthis is an approved alternative method for keeping track of vaccine
Resource bull Section 10 of the MnVFC Policy and Procedure Manual
IPI Advisor Manual | February 2017 Page 49
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
MnVFC Site Visit Storage and Handling Per Unit Answer Sheet 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet MnVFC PIN ___________________
Question number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
Temperature Monitoring Device Questions Questions 43 47 must be answered separately for the freezer and refrigerator if the unit is a combo Be sure to document responses in the appropriate column
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
All the questions on the Site Visit Storage amp Handling Per Unit Answer Sheet have been discussed previously in section 4 of this manual Use this sheet to record information about all the units at the site visit You will need one sheet for each unit If it is a combination unit (either pharmaceutical or household) you can record both sections on one sheet If they have stand-alone units use one sheet for each unit Do not enter the answers to the questions in section 4 of the questionnaire
If you need more information about any of the questions refer back to the main questionnairemdashthe complete question additional guidance including notes to the reviewer and the CDC requirements are there Also if the site is not meeting the requirement you will go back to the questionnaire to complete the ldquoActions if Non-compliantrdquo section including the root cause analysis and follow-up sections
When you have completed the assessment of all the storage units remember to go back to the questionnaire to complete sections 5 and 6
Page 50 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
ndash
ndash
MnVFC Provider Follow-up PlanThe goal of the Provider Follow-up Plan is to communicate with the site all of the VFC requirements any unmet requirements found during your site visit and the timeline for completing the required action The left hand column is a box to check for ldquoUnmetrdquo requirements
Helpful information bull The form can be used to review what the site is doing well and what they need to work on
bull For requirements that have specific documentation that needs to be sent to you use the notes section
2017 MnVFC Provider Follow-up Plan Site _______________________________________________ MnVFC PIN ____________ Date of Visit ___________
Thank you for participating in this MnVFC compliance site visit Please review this visit summary including follow-up actions and timelines for completion Unmet MnVFC requirements and recommendations have a checked box next to them The goal of this plan is to support you with successfully implementing the program and improving access to vaccines for VFC-eligible children
Unmet Question VFC Requirements Section 1 Changes to Key Staff
Q12 Change in the Medical Director Immunization Manager Vaccine Coordinator or back-upKey Staff must be communicated to the immunization program by emailing healthmnvfcstatemnus Changes Notes
Q12 Key staff must complete the annual training on VFC program requirements and print theAnnual Training certificate of completion Documentation Required Action
Staff that have not completed the MnVFC online training must complete it and send acopy of the certificate to the reviewer Training can be found on the MnVFC website (wwwhealthstatemnusvfc) Due date 1 month
Notes
Unmet Question VFC Requirements Section 2 Eligibility
Q21 Provider staff must possess a working knowledge of all VFC eligibility criteria and use thoseVFC Eligibility criteria to screen children prior to administering VFC vaccines
Categories Notes
bull This form provides documentation needed for follow-up actions when you send your thank you email
The second to last page of the Provider Follow-up Plan has a summary of the MnVFC program recommendations These are to remind the site about best practices they may want to improve upon even though they are not yet requirements of the program For example you could discuss the recommendation about storage units if they currently have a combination household unit and are using both sections
The last section is for your signature and the person you met with In most sites it will be the immunization manager or vaccine coordinator who signs the form unless the medical director attended the site visit You keep the original copy and the site will need to keep a copy for themselves
To be completed by the site visit reviewer
I acknowledge that a VFC site visit was performed on __________________ (visit date) The follow-up plan which includes a list of all current VFC program requirements and recommendations assessed during the visit and any required follow-up actions was provided at the end of the visit
Site visit reviewer
Phone
Reviewer Signature Date
To be completed by the provider
I acknowledge that our practice took part in the VFC site visit noted above I understand the findings of the visit and any required actions that must be taken by our office in order to meet VFC program requirements
Medical Director (or designee) Name Title
Medical Director (or designee) Signature Date
IPI Advisor Manual | February 2017 Page 51
The 2017 MnVFC Site Visit Paperwork Chapter 4
After the Site Visit Send a thank you email highlighting the unmet requirements documents you need from the site to resolve the issue(s) and the date you need them Make sure to include the link to the Site Visit Survey (httpssurveyvovicicomseashxs=56206EE334CE0B14)
Please refer to Chapter 3 for more information about future follow-up required after the visit including forms and documentation
Resource bull Sample Thank You letter on IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml)
Chapter 5
IPI Advisor Resource List MnVFC Program 651-201-5522
MnVFC wwwhealthstatemnusvfc
bull Separate Stock and Replacement Method Policies and Procedures Manuals bull Online trainings bull MnVFC Announcements sign up to receive them via email bull Ordering MDH vaccine bull MnVFC forms Screening forms Reporting forms Others MDH Nonviable Vaccine Form MDH Vaccine Transfer Record and Vaccine Borrowing Report
bull MnVFC promotional materials bull Immunization Billing Guidance for MnVFC and Immunization Billing Guidance for MnVFC Replacement Sites Immunization Practices Improvement Program (IPI) wwwhealthstatemnusdivsidepcimmunizeipi
bull IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml) bull IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml) IPI Resource Folder Contents (wwwhealthstatemnusdivsidepcimmunizeipiipifolderpdf)
Minnesota Immunization Information Connection (MIIC) wwwhealthstatemnusmiic
bull MIIC regions and regional coordinators
Clinical Practice MDH Immunization Program wwwhealthstatemnusimmunize
Got Your Shots News wwwhealthstatemnusdivsidepcnewslettersgys
MDH Immunization Information for Health Care Providers wwwhealthstatemnusdivsidepcimmunizehcp
bull Got Your Shots A Providers Guide to Immunization in Minnesota bull Vaccine protocols bull Forms for tracking patient immunizations bull Immunization schedules for Health Care Providers Immunization Action Coalition (IAC) wwwimmunizeorg
bull Ask the Experts bull VISs (Vaccine Information Statements and translations) bull Administration screening questions bull Medical management of vaccine reactions bull Order form for Californiarsquos Immunization Technique DVD Best Practices with Infants Children and Adults
Page 52 IPI Advisor Manual| February 2017
IPI Advisor Resource List Chapter 5
CDC ldquoPink Bookrdquo wwwcdcgovvaccinespubspinkbookindexhtml
CDC Advisory Committee on Immunization Practices (ACIP) wwwcdcgovvaccinesacip
CDC Vaccines and Immunizations wwwcdcgovvaccines
VAERS reporting httpvaershhsgovindex
Storage and Handling Got Your Shots Providers Guide ndash Managing Vaccine wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml
MnVFC Guide to Temperature Monitoring Devices wwwhealthstatemnusvfc
MDH Clinicianrsquos Vaccine Mishap Checklist wwwhealthstatemnusdivsidepcimmunizeipivaxchklstpdf
MDH Vaccine Storage Guide wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml
CDC Vaccine Storage and Handling Toolkit wwwcdcgovvaccinesrecsstoragetoolkit
You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Vaccine manufacturer phone numbers wwwcdcgovvaccinespubspinkbookdownloadsappendicesFcontact-info-manufactpdf
IAC Checklist for Safe Vaccine Handling and Storage wwwimmunizeorgcatgdp3035pdf
IAC Donrsquot Be Guilty of These Errors in Vaccine Storage and Handling wwwimmunizeorgcatgdp3036pdf
Additional Resources Print materials from MDH ndash order forms wwwhealthstatemnusdivsidepcimmunizeordermathtml
Vaccine Education Center ndash Childrenrsquos Hospital of Philadelphia wwwchopeduservicevaccine-education-centerhomehtml
California Department of Public Health ndash Interactive training on vaccine administration and storage and handling handout on transporting vaccine and how to package wwwezizorg
IPI Advisor Manual | February 2017 Page 53
IPI Advisor Resource List Chapter 5
CDC vaccine price list wwwcdcgovvaccinesprogramsvfcawardeesvaccine-managementprice-listindexhtml
Vaccine Information Statements (VIS) wwwcdcgovvaccineshcpvisindexhtml
CEU Opportunities CDC Immunization Education and Training wwwcdcgovvaccinesedindexhtml
Immunization You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Page 54 IPI Advisor Manual| February 2017
- Introduction
-
- Welcome to the Immunization Practice Improvement (IPI) Program
- Contact Information
-
- Chapter 1
- Requirements to Participate in the MnVFC Program
- Vaccines for Children Program
- Chapter 2
- Reimbursement for MnVFC Visits
- Types of Visits
- Your MnVFC Clinical CoordinatorPlanner
- New IPI Advisor Training Requirements
- Your Role as an IPI Advisor
- Reasons MDH Would Do All or Part of a Visit
- Chapter 3
- Future follow-up
- Conducting the Visit
- Preparing for the Visit
- Information for the Visit
- Site Visit Checklist
- Scheduling the Visit
- Chapter 4
- After the Site Visit
- MnVFC Provider Follow-up Plan
- MnVFC Site Visit Storage and Handling Per Unit Answer Sheet
- Section 6 Inventory
- Section 5 Storage amp Handling Site-Wide
- Section 4 Storage amp Handling Per Unit
- Section 3 Documentation
- Section 2 Eligibility
- Section 1 Provider Details
- The Site Visit Reviewer Legend
- MnVFC Site Visit Questionnaire
- Required Paperwork for Site Visits
- Chapter 5
-
IPI Advisor Manual | February 2017 Page 37
The 2017 MnVFC Site Visit Paperwork Chapter 4
For 45 E the provider is always responsible for supplying the current and valid certificate of calibration for a temperature monitoring device
bull Tip If the temperature monitoring device has a sticker on the back with the calibration date the site can usually call the company who calibrated the device and get a copy of the certificate if they donrsquot have one
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 46 4 Storage amp Handling Per Unit Probe Placement
Question 46 Is the probe properly placed in this section of the storage unit
Note to Reviewer ldquoProperlyrdquo means that the probe in a commercial or household unit is placed in a central area of the unitdirectly with the vaccines Probes should not be placed in the doors near or against the walls close to vents or on the floor of the unit The only allowable exemption related to this requirement is for providerswho have pharmaceutical storage units (built for vaccine storage) that have either (1) a built-intemperature monitoring device OR (2) a dedicated port for the probe that dictates the placement of theprobe
Answers (Choose one)
Yes No [X]
Review CDC Requirement
The probe must be placed in a central area of the section of the storage unit directly with the vaccines in order to properly measurevaccine temperature The probe should not be placed in the door near or against the walls close to vents or on the floor of theunit For pharmaceutical units with a built-in temperature monitoring device or a dedicated port for a probe that is not in thecenter of the section of the storage unit consult your Immunization Program for guidance on placement
Goal of this question Make sure the temperature monitoring device is in the best location to accurately measure the temperature of the vaccines stored in the unit
Helpful information bull The probe of the temperature monitoring device should be placed directly with the vaccines in the middle of the unit The ONLY allowable exception is for pharmaceutical storage units that have either a built-in thermometer or a dedicated port for the probe that indicates placement of the probe
bull Temperatures can vary within the unit especially household units bull Call MDH at 651-201-5522 if you have questions
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Guide (wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml)
Page 38 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 474 Storage amp Handling Per Unit Temperature Documentation
Question 47 Review the temperature documentation over the past three months for this section of the storage unit todetermine whether the provider has a process in place for properly documenting temperatures twice aday Answer the questions below
A Are there two temperature readings recorded for this section of the storage unit per day
Yes No [X]
B Is there a time date and name (or initials) recorded for each reading Yes No [X]
C What is the current temperature and minmax temperatures (if available) inthis section of the storage unit Use the reviewerrsquos thermometer if the providerrsquos temperature monitoringdevice does not have a current valid certificate of calibration testing or the probe is not properly placed in this section of the storage unit
Current Temperature Minimum Temperature Maximum Temperature Fahrenheit Celsius
D Based on your review of the providerrsquos recent temperature documentationincluding the current temperature is this section of the storage unitmaintaining appropriate temperatures
Yes No [X] Not enough information [X]
Review CDC Requirement
Vaccines must be stored under appropriate temperatures as described in the package inserts at all times Acceptable temperature ranges vary by vaccine type and the range is 36deg F and 46deg F (2deg C and 8deg C) and for frozen vaccines the range is -58deg F and +5deg F (shy50deg C and -15deg C) Exposure to temperatures outside of those included in the package inserts could affect vaccine viability andultimately could leave children unprotected against vaccine-preventable diseases In order to maintain awareness of storage unittemperatures and ensure that vaccines are being stored at appropriate temperatures at all times VFC providers are required to monitor and document temperatures for all vaccine storage units at least twice a day Temperature documentation must contain (1) at least two temperature readings per day (2) the time and date of each reading and (3) the name (or initials) of the personwho assessed and recorded the readings CDC also recommends that VFC providers record the minimum and maximumtemperatures of each unit once each workday (preferably in the morning)
Goal of this question Ensure the temperature is being monitored twice daily is within the required range and documented correctly Use your thermometer to check the temperature if the sitersquos temperature monitoring devicersquos probe is not properly placed or there is not a current certificate of calibration Place your thermometer in the unit at the beginning of the visit to allow sufficient time to reach an accurate temperature The purpose of using your thermometer is to ensure the vaccine is being stored at the proper temperature not to ldquovalidaterdquo their reading
Question 47 D is an assessment question based on information you have learned during your visit You might answer ldquonot enough informationrdquo if the unit is new and they donrsquot have at least three months of data or if the unit is only used as overflow and they are inconsistent with temperature monitoring Mark ldquoNordquo if you have reason to believe the storage unit is not maintaining temperatures properly
Helpful information bull All sites must document temperatures twice a day every day the site is open even if they have a data logger or continuous monitoring system
bull Sites can document the information electronically with some continuous monitoring systems as long as it can show what the current temp is the date time and initials of the person checking ndash this needs to be someone at the site ndash not checking remotely or centrally for a large site or system The site must be able to produce these records during their site visit Reviewing these files can be a challenge due to large volumes and lots of paper
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Temperature Logs on Managing Vaccine (wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml)
IPI Advisor Manual | February 2017 Page 39
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 484 Storage amp Handling Per Unit Temperature Excursions
Question 48 In the event that a temperature excursion(s) occurred in this unit within the last three months requestand review documentation of actions taken to determine whether the provider has a process for properlyaddressing excursions Answer the questions below
A Were vaccines in this unit exposed to out-of-range temperatures in the lastthree months (including today)
Yes No (If no skip to question 49)
B Did the provider quarantine and label vaccines as ldquoDo not userdquo Yes No [X]
C Did the provider place vaccine in a unit where it can be stored under properconditions if applicable
Yes No [X]
D Did the provider contact the Immunization Program to report theexcursion
Yes No [X]
E Was the manufacturer contacted for documentation supporting theusability of the vaccine
Yes No [X]
Review CDC Requirement
The provider must document all excursions and actions taken including the following (1) Quarantine and label vaccines as ldquoDO NOTUSErdquo (2) Place vaccines in a unit where they can be stored under proper conditions (3) Contact the Immunization Program to report an excursion and (4) Contact the vaccine manufacturer to obtain documentation supporting the usability of the vaccine
Goal of this question Address any out-of-range temperatures (temperature excursions) identified in reviewing the last three months of temperature logs or during the site visit If there were any out-of-range temperatures did the site respond appropriately to the situation This is a great opportunity to discuss what to do in the event of an excursion The Clinicians Storage and Handling Mishap Checklist is in the IPI Site Visit information folder and is a good review of the process
Helpful information bull Sites need to know that an excursion does not automatically mean that exposed vaccines are non-viable or unusable Exposed vaccines must be quarantined (marked ldquoDo Not Userdquo) and stored under proper conditions until they have received information from vaccine manufacturers regarding the viability of the vaccine
bull Sites must inform MDH when an excursion occurs
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Clinicians Storage and Handling Mishap Checklist (wwwhealthstatemnusdivsidepcimmunize ipivaxchklstpdf)
Page 40 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 49
Goal of this question Ensure proper placement of vaccines in the storage unit
Note These are all recommendations (best practices) not requirements
Helpful information bull Store vaccine in the middle of the compartment two to three inches away from the coils walls floor and cold air vent The temperature near the floor and walls of the unit differs from that in the middle of the compartment and the cold air vent can freeze refrigerated vaccines
4 Storage amp Handling Per Unit Vaccine Placement
Question 49 Look inside the unit to answer the questions below
A Are vaccines placed in the middle of the unit with space between vaccinesand the sideback of the unit to allow cold air to circulate
Yes No [O]
B Are vaccines stored in their original packages Yes No [O]
C Are there water bottles (for refrigerators) or frozen water bottles (forfreezers) in the unit
Yes No [O]
D Are vaccines store in the doors vegetable bins under or near cooling ventsor on the floor of the unit
Yes [O] No
E Is food being stored in the unit Yes [O] No
Review CDC Recommendation
Vaccines should be stored in their original manufacturer (or CDC centralized distributor) packaging They should be placed in the middle of the unit with space between the vaccines and the sideback of the unit to allow cold air to circulate Vaccines SHOULD NOT be stored in the doors vegetable bins or floor of the unit or under or near cooling vents and there should not be any food inthe unit Water bottles (for refrigerators) or frozen water bottles (for freezers) should be placed throughout each storage unit inorder to (1) stabilize or extend temperatures during a power outage and (2) to serve as physical blocks preventing the placementof vaccines in areas of the unit that are at higher risk for temperature excursions (such as in doors vegetable bins floor ornearunder cooling vents)
bull Vaccines should be kept in their original packaging to Protect them from light Help prevent medication errors by making labels easier to read Provide a moisture barrier that serves as insulation in case of an out-of-range temperature power outage door left open or mechanical failure Simplify managing vaccine inventory
bull Store water bottles in the doors on the floor and near the cold air vent in the refrigerator and frozen water bottles in the freezer to help maintain a stable temperature if there is a power failure and when the door is opened frequently Too many water bottles in the door can prevent the door from closing tightly Mark water bottles ldquoDo Not Drinkrdquo
bull Do not store vaccine in the door or drawers of the refrigerator or freezer Vegetable bins and crisper drawers should be removed from refrigerators or used to store other medical supplies or water bottles
bull If vaccine is stored in a household combination refrigeratorfreezer The top shelf should not be used for storing vaccine because the cold air vent blowing from the freezer will freeze vaccine located there If you must use the top shelf of this type of unit place water bottles underneath the cold air vent to prevent vaccine from being stored there It is recommended that only the refrigerator be used for vaccine storage and a separate stand-alone freezer be used to store frozen vaccine
bull Must not store food or beverages in the refrigerator or freezer because frequent opening of doors can lead to temperature variations that may affect vaccine viability There is also a risk of contaminating vaccines
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Guide (wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml) bull Vaccine Storage Tip Sheet on IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml)
IPI Advisor Manual | February 2017 Page 41
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 4104 Storage amp Handling Per Unit Disconnection from Power Source
Question 410 Ask the provider to demonstrate what measures are taken to ensure that vaccine storage units are notaccidentally physically disconnected from the power supply Which of the following describes the measure(s) taken on this unit
Note to Reviewer bull Large hospitals and healthcare systems may not have the ability to demonstrate labels on plugs or circuitbreakers In such cases verify that the practice has a comprehensive policy and standard operatingprocedures in place to prevent the vaccine storage unit from being physically disconnected from thepower supply
bull While back-up generators may ensure power to the overall facility this question ONLY addresses thevaccine storage unit being accidentally disconnected from the power source either through the plug orthe circuit breaker
Answers A ldquoDo not disconnectrdquo labels on the plug (Choose all that B ldquoWarningrdquo label on the circuit breaker box
apply) C Hard-wired (ie built-in) and has a ldquoDo not disconnectrdquo label on thecircuit breaker box D Hospital or large health care system with a comprehensive written policyand standard operating procedures detailing measures taken to preventvaccine storage units from being accidentally disconnected from the powersupply E No acceptable measures for preventing accidental disconnection frompower supply [X]
[X] The response is non-compliant if only A only B or E is selected
Review CDC Requirement
VFC providers must take steps to protect the power source for all vaccine storage equipment by means of having clear warninglabels on both the plug and the circuit breaker associated with all vaccine storage units Large hospitals and healthcare systems canmeet this requirement by demonstrating that they have comprehensive policies and standard operating procedures to preventvaccine storage units from being physically disconnected from the power supply
Goal of this question Decrease the chance that a vaccine storage unit will be accidently unplugged or power will be turned off while vaccine is in the unit This question addresses only what measures the site has taken to ensure the storage unit is not physically disconnected from its power source
If the site uses labels on the plugs and circuit breakers perform a visual inspection to assess whether the way the stickers are positioned make it clear and obvious to anyone that these units are not to be disconnected
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Do Not Unplug and Warning stickers are included in the folder or available to order on the For
Professionals Order Form (wwwhealthstatemnusdivsidepcimmunizeordermathtml)
Note Once you have completed the 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet for each unit return to the questionnaire to complete sections 5 and 6
Page 42 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
- -
Section 5 Storage amp Handling Site-Wide Question 51
5 Storage amp Handling Site Wide Discussion of Cost amp Quantity of Vaccine
Question 51 Have a discussion with the provider about the cost and quantity of VFC vaccines they are responsible for annually Address the points listed in the note to reviewer below
Note to Reviewer bull Vaccine Shipped (Required) Share the cost of VFC vaccines shipped to the provider in the last calendaryear to make sure the provider understands the contribution made by the VFC Program to their practiceFor new providers who do not have ldquocalendar yearrdquo data share either the actual cost of their currentinventory or use the cost of 10 VFC doses of each of the ACIP-recommended vaccines (approximately $7000) to help estimate their annual cost
bull Storage amp Handling (Required) Make sure the provider understands the cost of vaccines for which they are responsible when they make decisions about purchasing recommended vaccine storage and temperature monitoring equipment
Answer I have discussed with the provider the cost and quantity of vaccines ordered in the previous calendar year
Goal of this question Inform sites of the quantity and value of vaccines that they receive as part of the MnVFC program Providers often donrsquot realize the value of the vaccine in their unit This information is included on your clinic list and on the one page site-specific information
Helpful information bull This discussion must occur and the box on the questionnaire must be checked bull If there isnrsquot actual vaccine value information available tell the site that one vaccine order that includes a box of each of the ACIP recommended vaccines costs approximately $7000
bull MDH may not have specific information for individual sites if they receive vaccine from a central warehouse or pharmacy For those sites MDH will give you numbers for the whole system so you can discuss system wide data as appropriate If individual site information is also included it is usually just varicella-containing vaccines that must be shipped directly to the site
Question 52
5 Storage amp Handling Site Wide Dorm Style Units
Question 52 Determine whether the provider has any dorm-style units on site and answer the questions below
Note to Reviewer A dormitory-style refrigerator is a unit that has both refrigerator and freezer compartments behind a singleexterior door Dorm-style units also have an evaporator plate (cooling coil) which is usually located insidean icemaker compartment (freezer) within the refrigerator
A Does the provider have any dorm-style units that are used at any time tostore vaccines
Yes [X] No (Skip to question 53)
B Does the provider have sufficient space in existing compliant vaccinestorage units to store all vaccines without use of the dorm-style unit at any time
Yes No [X]
Review CDC Requirement
Dorm- and bar-style units are prohibited for vaccine storage Vaccines stored in dorm-style units are considered non-viable and must be returned to the centralized distributor CDC recommends the following vaccine storage unit types (in order of preference)pharmaceutical grade stand-alone or combination units (preferred) householdcommercial stand-alone unitshouseholdcommercial combination units using the refrigerator section only
Goal of this question Ensure no vaccine is stored in dorm-style units even for short periods of time Encourage them to label any units ldquoNo Vaccine Storage Allowedrdquo Vaccine stored in these units is considered non-viable If a site is using a dorm-style unit call the MnVFC program (651-201-5522)
Resource Section 8 in the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 43
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 535 Storage amp Handling Site Wide Storage Unit Space Availability
Question 53 Does the provider have sufficient room across storage units to store current stock as well as anyadditional stock acquired during peak season without overcrowding
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have sufficient storage space to accommodate vaccine stock at the busiest time of year without overcrowding
Goal of this question Ensure that sites have sufficient space in their units to maintain vaccines at the busiest time of year Overcrowding of vaccine limits air circulation and affects the unitrsquos ability to maintain stable temperatures
Helpful information bull Look for signs of overcrowding such as vaccines that are pushed up against the wall bins that are overflowing or storage units that are full during non-peak seasons
Discuss immediate actions if the unit is overcrowded Move some of their vaccines order less vaccine more frequently (once per month preferably) andor purchase another storage unit for overflow
Resource bull Section 8 MnVFC Policy and Procedure Manual
Page 44 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 545 Storage amp Handling Site Wide Expired Vaccines
Question 54 Look in each unit Are there expired vaccines in any of the vaccine storage units at this site
Answers (Choose one)
Yes [X] No
Review CDC Requirement
Vaccines should be rotated weekly and when a new shipment comes in so that longer-dated vaccines are stored behind shorter-dated vaccines If vaccines expire they can no longer be stored in the same storage unit with viable vaccines They must be placedin a container or bag clearly labeled ldquoDo not userdquo and separated from viable vaccines to prevent inadvertent use Expired vaccinemust be returned to the centralized distributor within six months of expiration
Goal of this question Ensure there is no expired vaccine in any storage unit
Helpful information bull Sites can prevent their stock from expiring by rotating vaccines every week andor when a new shipment arrives Longer-dated vaccines are stored towards the back of the unit and shorter-dated vaccines are up front
bull Pay attention to vaccines that expire within the next three months Consider transferring vaccine that will expire soon to another MnVFC-enrolled site that will use the vaccine preferably a site close by It is the transferring sitersquos responsibility to arrange the transfer of the vaccine Be sure to complete the MDH Vaccine Transfer Record form and send it to MDH If they are having difficulty finding a location to accept vaccine contact MDH
bull This is a great opportunity to educate sites about the MDH Nonviable Vaccine Form and the process for returning vaccine The VFC program does get some credit for taxes and fees on vaccine that is returned to the distribution center
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MDH Nonviable Vaccine Form and MDH Vaccine Transfer Record on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfcformshtml)
IPI Advisor Manual | February 2017 Page 45
The 2017 MnVFC Site Visit Paperwork Chapter 4
- -
-
Question 555 Storage amp Handling Site Wide Back up Thermometer
Question 55 Does the provider have a readily available back-up thermometer with a current and valid certificate ofcalibration testing
Note to Reviewer ldquoReadily availablerdquo means that the thermometer is available to perform twice-a-day monitoring for a unit asrequired CDC recommends that the back-up thermometer be maintained on site
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have a readily available back-up thermometer with a current and valid certificate of calibration testing Toprevent the certificates of calibration testing of the primary and back-up thermometers from expiring at the same time the date of calibration testing (or issue date) of the back-up thermometer should be different from the date of calibration testing (or issue date) of the primary thermometer As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meetsVFC program requirements
Goal of this question Ensure sites have one calibrated back-up thermometer onsite that is readily available in the event that the temperature monitoring device in unit fails transportation of vaccine is needed or there are other unexpected circumstances
Helpful information bull As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meets VFC Program requirements
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 56 5 Storage amp Handling Site Wide Preparation of Vaccine
Question 56 When does this provider prepare vaccine for administration to the patient
Note to Reviewer For mass vaccination clinics if one type of vaccine is offered providers may pre-draw up to 10 doses Ifusing pre-filled syringes pre-drawing also means activating the syringe by removing the needle guard orattaching a needle
Answers (Choose all that
apply)
Prepare dose immediately before administration Pre-draw doses for upcoming patients (in a regular clinicpractice) [O] Pre-draw up to 10 doses (in a mass-vaccination clinic) Pre-draw more than 10 doses (in a mass-vaccination clinic) [O] Other [O]
Review CDC Recommendation
CDC recommends preparing vaccines immediately prior to administration in order to assure viability of vaccine and prevent vaccinewastage Vaccines that are not administered immediately are at risk of exposure to temperatures outside of the required rangewhich can affect vaccine viability and ultimately can leave children unprotected against vaccine-preventable diseases
Goal of this question Discuss proper timing and preparation of vaccine(s) for administration These are recommendations not requirements
Helpful information bull Educate staff on the importance of preparing vaccine immediately before administration Pre-drawing of vaccines may lead to concerns related to vaccine viability potency sterility and wastage
Page 46 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 6 Inventory Question 61
6 Inventory Inventory Comparison
Question 61 Visually inspect storage units to determine if existing supply of vaccines proportionately mirrorspopulations served Choose the most accurate statement below
Note to Reviewer bull CDC recommends that providers maintain a four-week supply of inventory bull For this question do not take into account vaccine types that the provider does not order Here simply
make sure that overall the vaccines in the providerrsquos storage units are available in sufficient amounts toserve their patient population
Answers (Choose one)
The current vaccine inventory proportionately reflects the populations identified Only public stock is insufficient [X] Only private stock is insufficient [X] Both public and private stock are insufficient [X] Site uses the replacement method but does not appear to have enough vaccine for their population [X] Other [X]
Review CDC Requirement
VFC providers must order and stock routine vaccines in accordance with their patient population in order to prevent missedvaccination opportunities Having sufficient amounts of all stocks prevents the inadvertent use of VFC vaccines for non-VFC-eligiblepatients and vice versa
Goal of this question Assess whether the site is ordering appropriate quantities of vaccine for the population they serve at their site
Helpful information bull If the site sees 30 percent private-pay patients and 70 percent VFC the stock in their storage units should reflect that proportion If you donrsquot know you can ask the site about their population
bull This is meant to be a general assessment so in a big site if they have only a small amount of vaccine that may indicate an issue with vaccine management
bull CDC recommends smaller more frequent orders (ie monthly) rather than large orders to minimize the amount of vaccine loss if an incident occurs during shipment or in the storage unit Sites should not order more frequently than once a month
bull Sites using the replacement method will only have one stock but it should appear to be large enough for their population
bull Only assess the vaccine types that the site currently stocks in their unit We know there are sites that do not offer all ACIP-recommended vaccines for various reasons That issue will be addressed in question 62
IPI Advisor Manual | February 2017 Page 47
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 626 Inventory ACIP Recommended Vaccines
Question 62 Review providerrsquos current inventory to answer the questions below
A Does the provider offer all routine ACIP-recommendedvaccines for their patient population
Yes (Skip to question C) No [X] Offers all except varicella because direct ship ofvaccine is unavailable from manufacturer
B Which routine vaccines are NOT being offered DTaP Hepatitis A Hepatitis B HIB HPV Influenza Meningococcal
MMR Pneumococcal Polio Rotavirus TdapTd Varicella
C According to Immunization Program Policy does theprovider make accessible all non-routine ACIP-recommended vaccines for those VFC patients whomeet the criteria for receiving them
Yes (Skip to question 63) No [X]
D Which non-routine vaccines are NOT being offered Pneumococcal polysaccharide vaccine (PPSV23) Meningococcal Group B (MenB) Other
Review CDC Requirement
VFC providers agree to comply with immunization schedules dosages and contraindications that are established by the Advisory Committee on Immunization Practices (ACIP) for the vaccines identified and agreed upon in the Provider Agreement UNLESS bull In the VFC providers medical judgment and in accordance with accepted medical practice the VFC provider deems such
compliance to be medically inappropriate for the child bull The particular requirements contradict state law including laws pertaining to religious and other exemptions The VFC program entitles children to the following vaccines DTaP Hepatitis A Hepatitis B HIB HPV Influenza MeningococcalMMR Pneumococcal Polio Rotavirus TdapTd and Varicella VFC providers are also required to ensure that VFC-eligible children have access to non-routine vaccines as needed
Goal of this question Assess if the site is offering all the ACIP-recommended vaccines for the population they serve and these vaccines are in stock on the day of the visit It is important that every MnVFC-eligible child that comes to a providerrsquos office for an immunization is vaccinated
Helpful information bull The Advisory Committee on Immunization Practices (ACIP) is a group of medical and public health experts that develops recommendations on how to use vaccines to control diseases in the United States
bull Specialty providers are not required to offer all routine vaccines but should provide the vaccines appropriate for their population
bull If the site does not offer all routine ACIP-recommended vaccines appropriate for their population check the ldquoNordquo box in Part A then check the appropriate box(es) in Part B for any vaccines not offered Please contact MDH as this situation offers us the opportunity to provide education to the site
bull For non-routine vaccines they must either be in stock or the site must have an alternative protocol in the routine management plan that ensures these children have access when applicable
Resources bull IAC Diseases and Vaccines (wwwimmunizeorgvaccines) bull CDC Advisory Committee on Immunization Practices (ACIP) (wwwcdcgovvaccinesacipindexhtml)
Page 48 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 636 Inventory Separation of Stock
Question 63 Observe how the provider differentiates stock in each storage unit to answer the questions below
A Is it clear which vaccines belong to public stock andwhich belong to private stock
Yes No [X] Not applicable replacement site
B Is it clear which vaccines belong to VFC stock andwhich belong to UUAV stock
Yes No [X] Not applicable replacement site Not applicable not UUAV-enrolled site
Review CDC Requirement
In order to ensure that VFC vaccines are only administered to VFC-eligible children VFC providers that serve both VFC and non-VFCshyeligible children must maintain their vaccine inventories in such a way that they can clearly differentiate public stock from privatestock as well as VFC from other public stock
Goal of this question Assess whether the site can distinguish between MnVFC vaccine and private vaccine If they participate in the Uninsured and Underinsured Adult Vaccine (UUAV) program they should also be able to distinguish between MnVFC stock and UUAV stock Some sites use labels bins boxes etc to differentiate their stock If it is not clear how the site differentiates their stock discuss vaccine management with the staff For follow-up call MDH to discuss doing a follow-up site visit
Sites using the replacement method will not have separate stocksmdashthis is an approved alternative method for keeping track of vaccine
Resource bull Section 10 of the MnVFC Policy and Procedure Manual
IPI Advisor Manual | February 2017 Page 49
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
MnVFC Site Visit Storage and Handling Per Unit Answer Sheet 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet MnVFC PIN ___________________
Question number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
Temperature Monitoring Device Questions Questions 43 47 must be answered separately for the freezer and refrigerator if the unit is a combo Be sure to document responses in the appropriate column
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
All the questions on the Site Visit Storage amp Handling Per Unit Answer Sheet have been discussed previously in section 4 of this manual Use this sheet to record information about all the units at the site visit You will need one sheet for each unit If it is a combination unit (either pharmaceutical or household) you can record both sections on one sheet If they have stand-alone units use one sheet for each unit Do not enter the answers to the questions in section 4 of the questionnaire
If you need more information about any of the questions refer back to the main questionnairemdashthe complete question additional guidance including notes to the reviewer and the CDC requirements are there Also if the site is not meeting the requirement you will go back to the questionnaire to complete the ldquoActions if Non-compliantrdquo section including the root cause analysis and follow-up sections
When you have completed the assessment of all the storage units remember to go back to the questionnaire to complete sections 5 and 6
Page 50 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
ndash
ndash
MnVFC Provider Follow-up PlanThe goal of the Provider Follow-up Plan is to communicate with the site all of the VFC requirements any unmet requirements found during your site visit and the timeline for completing the required action The left hand column is a box to check for ldquoUnmetrdquo requirements
Helpful information bull The form can be used to review what the site is doing well and what they need to work on
bull For requirements that have specific documentation that needs to be sent to you use the notes section
2017 MnVFC Provider Follow-up Plan Site _______________________________________________ MnVFC PIN ____________ Date of Visit ___________
Thank you for participating in this MnVFC compliance site visit Please review this visit summary including follow-up actions and timelines for completion Unmet MnVFC requirements and recommendations have a checked box next to them The goal of this plan is to support you with successfully implementing the program and improving access to vaccines for VFC-eligible children
Unmet Question VFC Requirements Section 1 Changes to Key Staff
Q12 Change in the Medical Director Immunization Manager Vaccine Coordinator or back-upKey Staff must be communicated to the immunization program by emailing healthmnvfcstatemnus Changes Notes
Q12 Key staff must complete the annual training on VFC program requirements and print theAnnual Training certificate of completion Documentation Required Action
Staff that have not completed the MnVFC online training must complete it and send acopy of the certificate to the reviewer Training can be found on the MnVFC website (wwwhealthstatemnusvfc) Due date 1 month
Notes
Unmet Question VFC Requirements Section 2 Eligibility
Q21 Provider staff must possess a working knowledge of all VFC eligibility criteria and use thoseVFC Eligibility criteria to screen children prior to administering VFC vaccines
Categories Notes
bull This form provides documentation needed for follow-up actions when you send your thank you email
The second to last page of the Provider Follow-up Plan has a summary of the MnVFC program recommendations These are to remind the site about best practices they may want to improve upon even though they are not yet requirements of the program For example you could discuss the recommendation about storage units if they currently have a combination household unit and are using both sections
The last section is for your signature and the person you met with In most sites it will be the immunization manager or vaccine coordinator who signs the form unless the medical director attended the site visit You keep the original copy and the site will need to keep a copy for themselves
To be completed by the site visit reviewer
I acknowledge that a VFC site visit was performed on __________________ (visit date) The follow-up plan which includes a list of all current VFC program requirements and recommendations assessed during the visit and any required follow-up actions was provided at the end of the visit
Site visit reviewer
Phone
Reviewer Signature Date
To be completed by the provider
I acknowledge that our practice took part in the VFC site visit noted above I understand the findings of the visit and any required actions that must be taken by our office in order to meet VFC program requirements
Medical Director (or designee) Name Title
Medical Director (or designee) Signature Date
IPI Advisor Manual | February 2017 Page 51
The 2017 MnVFC Site Visit Paperwork Chapter 4
After the Site Visit Send a thank you email highlighting the unmet requirements documents you need from the site to resolve the issue(s) and the date you need them Make sure to include the link to the Site Visit Survey (httpssurveyvovicicomseashxs=56206EE334CE0B14)
Please refer to Chapter 3 for more information about future follow-up required after the visit including forms and documentation
Resource bull Sample Thank You letter on IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml)
Chapter 5
IPI Advisor Resource List MnVFC Program 651-201-5522
MnVFC wwwhealthstatemnusvfc
bull Separate Stock and Replacement Method Policies and Procedures Manuals bull Online trainings bull MnVFC Announcements sign up to receive them via email bull Ordering MDH vaccine bull MnVFC forms Screening forms Reporting forms Others MDH Nonviable Vaccine Form MDH Vaccine Transfer Record and Vaccine Borrowing Report
bull MnVFC promotional materials bull Immunization Billing Guidance for MnVFC and Immunization Billing Guidance for MnVFC Replacement Sites Immunization Practices Improvement Program (IPI) wwwhealthstatemnusdivsidepcimmunizeipi
bull IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml) bull IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml) IPI Resource Folder Contents (wwwhealthstatemnusdivsidepcimmunizeipiipifolderpdf)
Minnesota Immunization Information Connection (MIIC) wwwhealthstatemnusmiic
bull MIIC regions and regional coordinators
Clinical Practice MDH Immunization Program wwwhealthstatemnusimmunize
Got Your Shots News wwwhealthstatemnusdivsidepcnewslettersgys
MDH Immunization Information for Health Care Providers wwwhealthstatemnusdivsidepcimmunizehcp
bull Got Your Shots A Providers Guide to Immunization in Minnesota bull Vaccine protocols bull Forms for tracking patient immunizations bull Immunization schedules for Health Care Providers Immunization Action Coalition (IAC) wwwimmunizeorg
bull Ask the Experts bull VISs (Vaccine Information Statements and translations) bull Administration screening questions bull Medical management of vaccine reactions bull Order form for Californiarsquos Immunization Technique DVD Best Practices with Infants Children and Adults
Page 52 IPI Advisor Manual| February 2017
IPI Advisor Resource List Chapter 5
CDC ldquoPink Bookrdquo wwwcdcgovvaccinespubspinkbookindexhtml
CDC Advisory Committee on Immunization Practices (ACIP) wwwcdcgovvaccinesacip
CDC Vaccines and Immunizations wwwcdcgovvaccines
VAERS reporting httpvaershhsgovindex
Storage and Handling Got Your Shots Providers Guide ndash Managing Vaccine wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml
MnVFC Guide to Temperature Monitoring Devices wwwhealthstatemnusvfc
MDH Clinicianrsquos Vaccine Mishap Checklist wwwhealthstatemnusdivsidepcimmunizeipivaxchklstpdf
MDH Vaccine Storage Guide wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml
CDC Vaccine Storage and Handling Toolkit wwwcdcgovvaccinesrecsstoragetoolkit
You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Vaccine manufacturer phone numbers wwwcdcgovvaccinespubspinkbookdownloadsappendicesFcontact-info-manufactpdf
IAC Checklist for Safe Vaccine Handling and Storage wwwimmunizeorgcatgdp3035pdf
IAC Donrsquot Be Guilty of These Errors in Vaccine Storage and Handling wwwimmunizeorgcatgdp3036pdf
Additional Resources Print materials from MDH ndash order forms wwwhealthstatemnusdivsidepcimmunizeordermathtml
Vaccine Education Center ndash Childrenrsquos Hospital of Philadelphia wwwchopeduservicevaccine-education-centerhomehtml
California Department of Public Health ndash Interactive training on vaccine administration and storage and handling handout on transporting vaccine and how to package wwwezizorg
IPI Advisor Manual | February 2017 Page 53
IPI Advisor Resource List Chapter 5
CDC vaccine price list wwwcdcgovvaccinesprogramsvfcawardeesvaccine-managementprice-listindexhtml
Vaccine Information Statements (VIS) wwwcdcgovvaccineshcpvisindexhtml
CEU Opportunities CDC Immunization Education and Training wwwcdcgovvaccinesedindexhtml
Immunization You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Page 54 IPI Advisor Manual| February 2017
- Introduction
-
- Welcome to the Immunization Practice Improvement (IPI) Program
- Contact Information
-
- Chapter 1
- Requirements to Participate in the MnVFC Program
- Vaccines for Children Program
- Chapter 2
- Reimbursement for MnVFC Visits
- Types of Visits
- Your MnVFC Clinical CoordinatorPlanner
- New IPI Advisor Training Requirements
- Your Role as an IPI Advisor
- Reasons MDH Would Do All or Part of a Visit
- Chapter 3
- Future follow-up
- Conducting the Visit
- Preparing for the Visit
- Information for the Visit
- Site Visit Checklist
- Scheduling the Visit
- Chapter 4
- After the Site Visit
- MnVFC Provider Follow-up Plan
- MnVFC Site Visit Storage and Handling Per Unit Answer Sheet
- Section 6 Inventory
- Section 5 Storage amp Handling Site-Wide
- Section 4 Storage amp Handling Per Unit
- Section 3 Documentation
- Section 2 Eligibility
- Section 1 Provider Details
- The Site Visit Reviewer Legend
- MnVFC Site Visit Questionnaire
- Required Paperwork for Site Visits
- Chapter 5
-
Page 38 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 474 Storage amp Handling Per Unit Temperature Documentation
Question 47 Review the temperature documentation over the past three months for this section of the storage unit todetermine whether the provider has a process in place for properly documenting temperatures twice aday Answer the questions below
A Are there two temperature readings recorded for this section of the storage unit per day
Yes No [X]
B Is there a time date and name (or initials) recorded for each reading Yes No [X]
C What is the current temperature and minmax temperatures (if available) inthis section of the storage unit Use the reviewerrsquos thermometer if the providerrsquos temperature monitoringdevice does not have a current valid certificate of calibration testing or the probe is not properly placed in this section of the storage unit
Current Temperature Minimum Temperature Maximum Temperature Fahrenheit Celsius
D Based on your review of the providerrsquos recent temperature documentationincluding the current temperature is this section of the storage unitmaintaining appropriate temperatures
Yes No [X] Not enough information [X]
Review CDC Requirement
Vaccines must be stored under appropriate temperatures as described in the package inserts at all times Acceptable temperature ranges vary by vaccine type and the range is 36deg F and 46deg F (2deg C and 8deg C) and for frozen vaccines the range is -58deg F and +5deg F (shy50deg C and -15deg C) Exposure to temperatures outside of those included in the package inserts could affect vaccine viability andultimately could leave children unprotected against vaccine-preventable diseases In order to maintain awareness of storage unittemperatures and ensure that vaccines are being stored at appropriate temperatures at all times VFC providers are required to monitor and document temperatures for all vaccine storage units at least twice a day Temperature documentation must contain (1) at least two temperature readings per day (2) the time and date of each reading and (3) the name (or initials) of the personwho assessed and recorded the readings CDC also recommends that VFC providers record the minimum and maximumtemperatures of each unit once each workday (preferably in the morning)
Goal of this question Ensure the temperature is being monitored twice daily is within the required range and documented correctly Use your thermometer to check the temperature if the sitersquos temperature monitoring devicersquos probe is not properly placed or there is not a current certificate of calibration Place your thermometer in the unit at the beginning of the visit to allow sufficient time to reach an accurate temperature The purpose of using your thermometer is to ensure the vaccine is being stored at the proper temperature not to ldquovalidaterdquo their reading
Question 47 D is an assessment question based on information you have learned during your visit You might answer ldquonot enough informationrdquo if the unit is new and they donrsquot have at least three months of data or if the unit is only used as overflow and they are inconsistent with temperature monitoring Mark ldquoNordquo if you have reason to believe the storage unit is not maintaining temperatures properly
Helpful information bull All sites must document temperatures twice a day every day the site is open even if they have a data logger or continuous monitoring system
bull Sites can document the information electronically with some continuous monitoring systems as long as it can show what the current temp is the date time and initials of the person checking ndash this needs to be someone at the site ndash not checking remotely or centrally for a large site or system The site must be able to produce these records during their site visit Reviewing these files can be a challenge due to large volumes and lots of paper
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Temperature Logs on Managing Vaccine (wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml)
IPI Advisor Manual | February 2017 Page 39
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 484 Storage amp Handling Per Unit Temperature Excursions
Question 48 In the event that a temperature excursion(s) occurred in this unit within the last three months requestand review documentation of actions taken to determine whether the provider has a process for properlyaddressing excursions Answer the questions below
A Were vaccines in this unit exposed to out-of-range temperatures in the lastthree months (including today)
Yes No (If no skip to question 49)
B Did the provider quarantine and label vaccines as ldquoDo not userdquo Yes No [X]
C Did the provider place vaccine in a unit where it can be stored under properconditions if applicable
Yes No [X]
D Did the provider contact the Immunization Program to report theexcursion
Yes No [X]
E Was the manufacturer contacted for documentation supporting theusability of the vaccine
Yes No [X]
Review CDC Requirement
The provider must document all excursions and actions taken including the following (1) Quarantine and label vaccines as ldquoDO NOTUSErdquo (2) Place vaccines in a unit where they can be stored under proper conditions (3) Contact the Immunization Program to report an excursion and (4) Contact the vaccine manufacturer to obtain documentation supporting the usability of the vaccine
Goal of this question Address any out-of-range temperatures (temperature excursions) identified in reviewing the last three months of temperature logs or during the site visit If there were any out-of-range temperatures did the site respond appropriately to the situation This is a great opportunity to discuss what to do in the event of an excursion The Clinicians Storage and Handling Mishap Checklist is in the IPI Site Visit information folder and is a good review of the process
Helpful information bull Sites need to know that an excursion does not automatically mean that exposed vaccines are non-viable or unusable Exposed vaccines must be quarantined (marked ldquoDo Not Userdquo) and stored under proper conditions until they have received information from vaccine manufacturers regarding the viability of the vaccine
bull Sites must inform MDH when an excursion occurs
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Clinicians Storage and Handling Mishap Checklist (wwwhealthstatemnusdivsidepcimmunize ipivaxchklstpdf)
Page 40 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 49
Goal of this question Ensure proper placement of vaccines in the storage unit
Note These are all recommendations (best practices) not requirements
Helpful information bull Store vaccine in the middle of the compartment two to three inches away from the coils walls floor and cold air vent The temperature near the floor and walls of the unit differs from that in the middle of the compartment and the cold air vent can freeze refrigerated vaccines
4 Storage amp Handling Per Unit Vaccine Placement
Question 49 Look inside the unit to answer the questions below
A Are vaccines placed in the middle of the unit with space between vaccinesand the sideback of the unit to allow cold air to circulate
Yes No [O]
B Are vaccines stored in their original packages Yes No [O]
C Are there water bottles (for refrigerators) or frozen water bottles (forfreezers) in the unit
Yes No [O]
D Are vaccines store in the doors vegetable bins under or near cooling ventsor on the floor of the unit
Yes [O] No
E Is food being stored in the unit Yes [O] No
Review CDC Recommendation
Vaccines should be stored in their original manufacturer (or CDC centralized distributor) packaging They should be placed in the middle of the unit with space between the vaccines and the sideback of the unit to allow cold air to circulate Vaccines SHOULD NOT be stored in the doors vegetable bins or floor of the unit or under or near cooling vents and there should not be any food inthe unit Water bottles (for refrigerators) or frozen water bottles (for freezers) should be placed throughout each storage unit inorder to (1) stabilize or extend temperatures during a power outage and (2) to serve as physical blocks preventing the placementof vaccines in areas of the unit that are at higher risk for temperature excursions (such as in doors vegetable bins floor ornearunder cooling vents)
bull Vaccines should be kept in their original packaging to Protect them from light Help prevent medication errors by making labels easier to read Provide a moisture barrier that serves as insulation in case of an out-of-range temperature power outage door left open or mechanical failure Simplify managing vaccine inventory
bull Store water bottles in the doors on the floor and near the cold air vent in the refrigerator and frozen water bottles in the freezer to help maintain a stable temperature if there is a power failure and when the door is opened frequently Too many water bottles in the door can prevent the door from closing tightly Mark water bottles ldquoDo Not Drinkrdquo
bull Do not store vaccine in the door or drawers of the refrigerator or freezer Vegetable bins and crisper drawers should be removed from refrigerators or used to store other medical supplies or water bottles
bull If vaccine is stored in a household combination refrigeratorfreezer The top shelf should not be used for storing vaccine because the cold air vent blowing from the freezer will freeze vaccine located there If you must use the top shelf of this type of unit place water bottles underneath the cold air vent to prevent vaccine from being stored there It is recommended that only the refrigerator be used for vaccine storage and a separate stand-alone freezer be used to store frozen vaccine
bull Must not store food or beverages in the refrigerator or freezer because frequent opening of doors can lead to temperature variations that may affect vaccine viability There is also a risk of contaminating vaccines
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Guide (wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml) bull Vaccine Storage Tip Sheet on IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml)
IPI Advisor Manual | February 2017 Page 41
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 4104 Storage amp Handling Per Unit Disconnection from Power Source
Question 410 Ask the provider to demonstrate what measures are taken to ensure that vaccine storage units are notaccidentally physically disconnected from the power supply Which of the following describes the measure(s) taken on this unit
Note to Reviewer bull Large hospitals and healthcare systems may not have the ability to demonstrate labels on plugs or circuitbreakers In such cases verify that the practice has a comprehensive policy and standard operatingprocedures in place to prevent the vaccine storage unit from being physically disconnected from thepower supply
bull While back-up generators may ensure power to the overall facility this question ONLY addresses thevaccine storage unit being accidentally disconnected from the power source either through the plug orthe circuit breaker
Answers A ldquoDo not disconnectrdquo labels on the plug (Choose all that B ldquoWarningrdquo label on the circuit breaker box
apply) C Hard-wired (ie built-in) and has a ldquoDo not disconnectrdquo label on thecircuit breaker box D Hospital or large health care system with a comprehensive written policyand standard operating procedures detailing measures taken to preventvaccine storage units from being accidentally disconnected from the powersupply E No acceptable measures for preventing accidental disconnection frompower supply [X]
[X] The response is non-compliant if only A only B or E is selected
Review CDC Requirement
VFC providers must take steps to protect the power source for all vaccine storage equipment by means of having clear warninglabels on both the plug and the circuit breaker associated with all vaccine storage units Large hospitals and healthcare systems canmeet this requirement by demonstrating that they have comprehensive policies and standard operating procedures to preventvaccine storage units from being physically disconnected from the power supply
Goal of this question Decrease the chance that a vaccine storage unit will be accidently unplugged or power will be turned off while vaccine is in the unit This question addresses only what measures the site has taken to ensure the storage unit is not physically disconnected from its power source
If the site uses labels on the plugs and circuit breakers perform a visual inspection to assess whether the way the stickers are positioned make it clear and obvious to anyone that these units are not to be disconnected
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Do Not Unplug and Warning stickers are included in the folder or available to order on the For
Professionals Order Form (wwwhealthstatemnusdivsidepcimmunizeordermathtml)
Note Once you have completed the 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet for each unit return to the questionnaire to complete sections 5 and 6
Page 42 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
- -
Section 5 Storage amp Handling Site-Wide Question 51
5 Storage amp Handling Site Wide Discussion of Cost amp Quantity of Vaccine
Question 51 Have a discussion with the provider about the cost and quantity of VFC vaccines they are responsible for annually Address the points listed in the note to reviewer below
Note to Reviewer bull Vaccine Shipped (Required) Share the cost of VFC vaccines shipped to the provider in the last calendaryear to make sure the provider understands the contribution made by the VFC Program to their practiceFor new providers who do not have ldquocalendar yearrdquo data share either the actual cost of their currentinventory or use the cost of 10 VFC doses of each of the ACIP-recommended vaccines (approximately $7000) to help estimate their annual cost
bull Storage amp Handling (Required) Make sure the provider understands the cost of vaccines for which they are responsible when they make decisions about purchasing recommended vaccine storage and temperature monitoring equipment
Answer I have discussed with the provider the cost and quantity of vaccines ordered in the previous calendar year
Goal of this question Inform sites of the quantity and value of vaccines that they receive as part of the MnVFC program Providers often donrsquot realize the value of the vaccine in their unit This information is included on your clinic list and on the one page site-specific information
Helpful information bull This discussion must occur and the box on the questionnaire must be checked bull If there isnrsquot actual vaccine value information available tell the site that one vaccine order that includes a box of each of the ACIP recommended vaccines costs approximately $7000
bull MDH may not have specific information for individual sites if they receive vaccine from a central warehouse or pharmacy For those sites MDH will give you numbers for the whole system so you can discuss system wide data as appropriate If individual site information is also included it is usually just varicella-containing vaccines that must be shipped directly to the site
Question 52
5 Storage amp Handling Site Wide Dorm Style Units
Question 52 Determine whether the provider has any dorm-style units on site and answer the questions below
Note to Reviewer A dormitory-style refrigerator is a unit that has both refrigerator and freezer compartments behind a singleexterior door Dorm-style units also have an evaporator plate (cooling coil) which is usually located insidean icemaker compartment (freezer) within the refrigerator
A Does the provider have any dorm-style units that are used at any time tostore vaccines
Yes [X] No (Skip to question 53)
B Does the provider have sufficient space in existing compliant vaccinestorage units to store all vaccines without use of the dorm-style unit at any time
Yes No [X]
Review CDC Requirement
Dorm- and bar-style units are prohibited for vaccine storage Vaccines stored in dorm-style units are considered non-viable and must be returned to the centralized distributor CDC recommends the following vaccine storage unit types (in order of preference)pharmaceutical grade stand-alone or combination units (preferred) householdcommercial stand-alone unitshouseholdcommercial combination units using the refrigerator section only
Goal of this question Ensure no vaccine is stored in dorm-style units even for short periods of time Encourage them to label any units ldquoNo Vaccine Storage Allowedrdquo Vaccine stored in these units is considered non-viable If a site is using a dorm-style unit call the MnVFC program (651-201-5522)
Resource Section 8 in the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 43
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 535 Storage amp Handling Site Wide Storage Unit Space Availability
Question 53 Does the provider have sufficient room across storage units to store current stock as well as anyadditional stock acquired during peak season without overcrowding
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have sufficient storage space to accommodate vaccine stock at the busiest time of year without overcrowding
Goal of this question Ensure that sites have sufficient space in their units to maintain vaccines at the busiest time of year Overcrowding of vaccine limits air circulation and affects the unitrsquos ability to maintain stable temperatures
Helpful information bull Look for signs of overcrowding such as vaccines that are pushed up against the wall bins that are overflowing or storage units that are full during non-peak seasons
Discuss immediate actions if the unit is overcrowded Move some of their vaccines order less vaccine more frequently (once per month preferably) andor purchase another storage unit for overflow
Resource bull Section 8 MnVFC Policy and Procedure Manual
Page 44 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 545 Storage amp Handling Site Wide Expired Vaccines
Question 54 Look in each unit Are there expired vaccines in any of the vaccine storage units at this site
Answers (Choose one)
Yes [X] No
Review CDC Requirement
Vaccines should be rotated weekly and when a new shipment comes in so that longer-dated vaccines are stored behind shorter-dated vaccines If vaccines expire they can no longer be stored in the same storage unit with viable vaccines They must be placedin a container or bag clearly labeled ldquoDo not userdquo and separated from viable vaccines to prevent inadvertent use Expired vaccinemust be returned to the centralized distributor within six months of expiration
Goal of this question Ensure there is no expired vaccine in any storage unit
Helpful information bull Sites can prevent their stock from expiring by rotating vaccines every week andor when a new shipment arrives Longer-dated vaccines are stored towards the back of the unit and shorter-dated vaccines are up front
bull Pay attention to vaccines that expire within the next three months Consider transferring vaccine that will expire soon to another MnVFC-enrolled site that will use the vaccine preferably a site close by It is the transferring sitersquos responsibility to arrange the transfer of the vaccine Be sure to complete the MDH Vaccine Transfer Record form and send it to MDH If they are having difficulty finding a location to accept vaccine contact MDH
bull This is a great opportunity to educate sites about the MDH Nonviable Vaccine Form and the process for returning vaccine The VFC program does get some credit for taxes and fees on vaccine that is returned to the distribution center
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MDH Nonviable Vaccine Form and MDH Vaccine Transfer Record on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfcformshtml)
IPI Advisor Manual | February 2017 Page 45
The 2017 MnVFC Site Visit Paperwork Chapter 4
- -
-
Question 555 Storage amp Handling Site Wide Back up Thermometer
Question 55 Does the provider have a readily available back-up thermometer with a current and valid certificate ofcalibration testing
Note to Reviewer ldquoReadily availablerdquo means that the thermometer is available to perform twice-a-day monitoring for a unit asrequired CDC recommends that the back-up thermometer be maintained on site
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have a readily available back-up thermometer with a current and valid certificate of calibration testing Toprevent the certificates of calibration testing of the primary and back-up thermometers from expiring at the same time the date of calibration testing (or issue date) of the back-up thermometer should be different from the date of calibration testing (or issue date) of the primary thermometer As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meetsVFC program requirements
Goal of this question Ensure sites have one calibrated back-up thermometer onsite that is readily available in the event that the temperature monitoring device in unit fails transportation of vaccine is needed or there are other unexpected circumstances
Helpful information bull As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meets VFC Program requirements
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 56 5 Storage amp Handling Site Wide Preparation of Vaccine
Question 56 When does this provider prepare vaccine for administration to the patient
Note to Reviewer For mass vaccination clinics if one type of vaccine is offered providers may pre-draw up to 10 doses Ifusing pre-filled syringes pre-drawing also means activating the syringe by removing the needle guard orattaching a needle
Answers (Choose all that
apply)
Prepare dose immediately before administration Pre-draw doses for upcoming patients (in a regular clinicpractice) [O] Pre-draw up to 10 doses (in a mass-vaccination clinic) Pre-draw more than 10 doses (in a mass-vaccination clinic) [O] Other [O]
Review CDC Recommendation
CDC recommends preparing vaccines immediately prior to administration in order to assure viability of vaccine and prevent vaccinewastage Vaccines that are not administered immediately are at risk of exposure to temperatures outside of the required rangewhich can affect vaccine viability and ultimately can leave children unprotected against vaccine-preventable diseases
Goal of this question Discuss proper timing and preparation of vaccine(s) for administration These are recommendations not requirements
Helpful information bull Educate staff on the importance of preparing vaccine immediately before administration Pre-drawing of vaccines may lead to concerns related to vaccine viability potency sterility and wastage
Page 46 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 6 Inventory Question 61
6 Inventory Inventory Comparison
Question 61 Visually inspect storage units to determine if existing supply of vaccines proportionately mirrorspopulations served Choose the most accurate statement below
Note to Reviewer bull CDC recommends that providers maintain a four-week supply of inventory bull For this question do not take into account vaccine types that the provider does not order Here simply
make sure that overall the vaccines in the providerrsquos storage units are available in sufficient amounts toserve their patient population
Answers (Choose one)
The current vaccine inventory proportionately reflects the populations identified Only public stock is insufficient [X] Only private stock is insufficient [X] Both public and private stock are insufficient [X] Site uses the replacement method but does not appear to have enough vaccine for their population [X] Other [X]
Review CDC Requirement
VFC providers must order and stock routine vaccines in accordance with their patient population in order to prevent missedvaccination opportunities Having sufficient amounts of all stocks prevents the inadvertent use of VFC vaccines for non-VFC-eligiblepatients and vice versa
Goal of this question Assess whether the site is ordering appropriate quantities of vaccine for the population they serve at their site
Helpful information bull If the site sees 30 percent private-pay patients and 70 percent VFC the stock in their storage units should reflect that proportion If you donrsquot know you can ask the site about their population
bull This is meant to be a general assessment so in a big site if they have only a small amount of vaccine that may indicate an issue with vaccine management
bull CDC recommends smaller more frequent orders (ie monthly) rather than large orders to minimize the amount of vaccine loss if an incident occurs during shipment or in the storage unit Sites should not order more frequently than once a month
bull Sites using the replacement method will only have one stock but it should appear to be large enough for their population
bull Only assess the vaccine types that the site currently stocks in their unit We know there are sites that do not offer all ACIP-recommended vaccines for various reasons That issue will be addressed in question 62
IPI Advisor Manual | February 2017 Page 47
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 626 Inventory ACIP Recommended Vaccines
Question 62 Review providerrsquos current inventory to answer the questions below
A Does the provider offer all routine ACIP-recommendedvaccines for their patient population
Yes (Skip to question C) No [X] Offers all except varicella because direct ship ofvaccine is unavailable from manufacturer
B Which routine vaccines are NOT being offered DTaP Hepatitis A Hepatitis B HIB HPV Influenza Meningococcal
MMR Pneumococcal Polio Rotavirus TdapTd Varicella
C According to Immunization Program Policy does theprovider make accessible all non-routine ACIP-recommended vaccines for those VFC patients whomeet the criteria for receiving them
Yes (Skip to question 63) No [X]
D Which non-routine vaccines are NOT being offered Pneumococcal polysaccharide vaccine (PPSV23) Meningococcal Group B (MenB) Other
Review CDC Requirement
VFC providers agree to comply with immunization schedules dosages and contraindications that are established by the Advisory Committee on Immunization Practices (ACIP) for the vaccines identified and agreed upon in the Provider Agreement UNLESS bull In the VFC providers medical judgment and in accordance with accepted medical practice the VFC provider deems such
compliance to be medically inappropriate for the child bull The particular requirements contradict state law including laws pertaining to religious and other exemptions The VFC program entitles children to the following vaccines DTaP Hepatitis A Hepatitis B HIB HPV Influenza MeningococcalMMR Pneumococcal Polio Rotavirus TdapTd and Varicella VFC providers are also required to ensure that VFC-eligible children have access to non-routine vaccines as needed
Goal of this question Assess if the site is offering all the ACIP-recommended vaccines for the population they serve and these vaccines are in stock on the day of the visit It is important that every MnVFC-eligible child that comes to a providerrsquos office for an immunization is vaccinated
Helpful information bull The Advisory Committee on Immunization Practices (ACIP) is a group of medical and public health experts that develops recommendations on how to use vaccines to control diseases in the United States
bull Specialty providers are not required to offer all routine vaccines but should provide the vaccines appropriate for their population
bull If the site does not offer all routine ACIP-recommended vaccines appropriate for their population check the ldquoNordquo box in Part A then check the appropriate box(es) in Part B for any vaccines not offered Please contact MDH as this situation offers us the opportunity to provide education to the site
bull For non-routine vaccines they must either be in stock or the site must have an alternative protocol in the routine management plan that ensures these children have access when applicable
Resources bull IAC Diseases and Vaccines (wwwimmunizeorgvaccines) bull CDC Advisory Committee on Immunization Practices (ACIP) (wwwcdcgovvaccinesacipindexhtml)
Page 48 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 636 Inventory Separation of Stock
Question 63 Observe how the provider differentiates stock in each storage unit to answer the questions below
A Is it clear which vaccines belong to public stock andwhich belong to private stock
Yes No [X] Not applicable replacement site
B Is it clear which vaccines belong to VFC stock andwhich belong to UUAV stock
Yes No [X] Not applicable replacement site Not applicable not UUAV-enrolled site
Review CDC Requirement
In order to ensure that VFC vaccines are only administered to VFC-eligible children VFC providers that serve both VFC and non-VFCshyeligible children must maintain their vaccine inventories in such a way that they can clearly differentiate public stock from privatestock as well as VFC from other public stock
Goal of this question Assess whether the site can distinguish between MnVFC vaccine and private vaccine If they participate in the Uninsured and Underinsured Adult Vaccine (UUAV) program they should also be able to distinguish between MnVFC stock and UUAV stock Some sites use labels bins boxes etc to differentiate their stock If it is not clear how the site differentiates their stock discuss vaccine management with the staff For follow-up call MDH to discuss doing a follow-up site visit
Sites using the replacement method will not have separate stocksmdashthis is an approved alternative method for keeping track of vaccine
Resource bull Section 10 of the MnVFC Policy and Procedure Manual
IPI Advisor Manual | February 2017 Page 49
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
MnVFC Site Visit Storage and Handling Per Unit Answer Sheet 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet MnVFC PIN ___________________
Question number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
Temperature Monitoring Device Questions Questions 43 47 must be answered separately for the freezer and refrigerator if the unit is a combo Be sure to document responses in the appropriate column
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
All the questions on the Site Visit Storage amp Handling Per Unit Answer Sheet have been discussed previously in section 4 of this manual Use this sheet to record information about all the units at the site visit You will need one sheet for each unit If it is a combination unit (either pharmaceutical or household) you can record both sections on one sheet If they have stand-alone units use one sheet for each unit Do not enter the answers to the questions in section 4 of the questionnaire
If you need more information about any of the questions refer back to the main questionnairemdashthe complete question additional guidance including notes to the reviewer and the CDC requirements are there Also if the site is not meeting the requirement you will go back to the questionnaire to complete the ldquoActions if Non-compliantrdquo section including the root cause analysis and follow-up sections
When you have completed the assessment of all the storage units remember to go back to the questionnaire to complete sections 5 and 6
Page 50 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
ndash
ndash
MnVFC Provider Follow-up PlanThe goal of the Provider Follow-up Plan is to communicate with the site all of the VFC requirements any unmet requirements found during your site visit and the timeline for completing the required action The left hand column is a box to check for ldquoUnmetrdquo requirements
Helpful information bull The form can be used to review what the site is doing well and what they need to work on
bull For requirements that have specific documentation that needs to be sent to you use the notes section
2017 MnVFC Provider Follow-up Plan Site _______________________________________________ MnVFC PIN ____________ Date of Visit ___________
Thank you for participating in this MnVFC compliance site visit Please review this visit summary including follow-up actions and timelines for completion Unmet MnVFC requirements and recommendations have a checked box next to them The goal of this plan is to support you with successfully implementing the program and improving access to vaccines for VFC-eligible children
Unmet Question VFC Requirements Section 1 Changes to Key Staff
Q12 Change in the Medical Director Immunization Manager Vaccine Coordinator or back-upKey Staff must be communicated to the immunization program by emailing healthmnvfcstatemnus Changes Notes
Q12 Key staff must complete the annual training on VFC program requirements and print theAnnual Training certificate of completion Documentation Required Action
Staff that have not completed the MnVFC online training must complete it and send acopy of the certificate to the reviewer Training can be found on the MnVFC website (wwwhealthstatemnusvfc) Due date 1 month
Notes
Unmet Question VFC Requirements Section 2 Eligibility
Q21 Provider staff must possess a working knowledge of all VFC eligibility criteria and use thoseVFC Eligibility criteria to screen children prior to administering VFC vaccines
Categories Notes
bull This form provides documentation needed for follow-up actions when you send your thank you email
The second to last page of the Provider Follow-up Plan has a summary of the MnVFC program recommendations These are to remind the site about best practices they may want to improve upon even though they are not yet requirements of the program For example you could discuss the recommendation about storage units if they currently have a combination household unit and are using both sections
The last section is for your signature and the person you met with In most sites it will be the immunization manager or vaccine coordinator who signs the form unless the medical director attended the site visit You keep the original copy and the site will need to keep a copy for themselves
To be completed by the site visit reviewer
I acknowledge that a VFC site visit was performed on __________________ (visit date) The follow-up plan which includes a list of all current VFC program requirements and recommendations assessed during the visit and any required follow-up actions was provided at the end of the visit
Site visit reviewer
Phone
Reviewer Signature Date
To be completed by the provider
I acknowledge that our practice took part in the VFC site visit noted above I understand the findings of the visit and any required actions that must be taken by our office in order to meet VFC program requirements
Medical Director (or designee) Name Title
Medical Director (or designee) Signature Date
IPI Advisor Manual | February 2017 Page 51
The 2017 MnVFC Site Visit Paperwork Chapter 4
After the Site Visit Send a thank you email highlighting the unmet requirements documents you need from the site to resolve the issue(s) and the date you need them Make sure to include the link to the Site Visit Survey (httpssurveyvovicicomseashxs=56206EE334CE0B14)
Please refer to Chapter 3 for more information about future follow-up required after the visit including forms and documentation
Resource bull Sample Thank You letter on IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml)
Chapter 5
IPI Advisor Resource List MnVFC Program 651-201-5522
MnVFC wwwhealthstatemnusvfc
bull Separate Stock and Replacement Method Policies and Procedures Manuals bull Online trainings bull MnVFC Announcements sign up to receive them via email bull Ordering MDH vaccine bull MnVFC forms Screening forms Reporting forms Others MDH Nonviable Vaccine Form MDH Vaccine Transfer Record and Vaccine Borrowing Report
bull MnVFC promotional materials bull Immunization Billing Guidance for MnVFC and Immunization Billing Guidance for MnVFC Replacement Sites Immunization Practices Improvement Program (IPI) wwwhealthstatemnusdivsidepcimmunizeipi
bull IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml) bull IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml) IPI Resource Folder Contents (wwwhealthstatemnusdivsidepcimmunizeipiipifolderpdf)
Minnesota Immunization Information Connection (MIIC) wwwhealthstatemnusmiic
bull MIIC regions and regional coordinators
Clinical Practice MDH Immunization Program wwwhealthstatemnusimmunize
Got Your Shots News wwwhealthstatemnusdivsidepcnewslettersgys
MDH Immunization Information for Health Care Providers wwwhealthstatemnusdivsidepcimmunizehcp
bull Got Your Shots A Providers Guide to Immunization in Minnesota bull Vaccine protocols bull Forms for tracking patient immunizations bull Immunization schedules for Health Care Providers Immunization Action Coalition (IAC) wwwimmunizeorg
bull Ask the Experts bull VISs (Vaccine Information Statements and translations) bull Administration screening questions bull Medical management of vaccine reactions bull Order form for Californiarsquos Immunization Technique DVD Best Practices with Infants Children and Adults
Page 52 IPI Advisor Manual| February 2017
IPI Advisor Resource List Chapter 5
CDC ldquoPink Bookrdquo wwwcdcgovvaccinespubspinkbookindexhtml
CDC Advisory Committee on Immunization Practices (ACIP) wwwcdcgovvaccinesacip
CDC Vaccines and Immunizations wwwcdcgovvaccines
VAERS reporting httpvaershhsgovindex
Storage and Handling Got Your Shots Providers Guide ndash Managing Vaccine wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml
MnVFC Guide to Temperature Monitoring Devices wwwhealthstatemnusvfc
MDH Clinicianrsquos Vaccine Mishap Checklist wwwhealthstatemnusdivsidepcimmunizeipivaxchklstpdf
MDH Vaccine Storage Guide wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml
CDC Vaccine Storage and Handling Toolkit wwwcdcgovvaccinesrecsstoragetoolkit
You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Vaccine manufacturer phone numbers wwwcdcgovvaccinespubspinkbookdownloadsappendicesFcontact-info-manufactpdf
IAC Checklist for Safe Vaccine Handling and Storage wwwimmunizeorgcatgdp3035pdf
IAC Donrsquot Be Guilty of These Errors in Vaccine Storage and Handling wwwimmunizeorgcatgdp3036pdf
Additional Resources Print materials from MDH ndash order forms wwwhealthstatemnusdivsidepcimmunizeordermathtml
Vaccine Education Center ndash Childrenrsquos Hospital of Philadelphia wwwchopeduservicevaccine-education-centerhomehtml
California Department of Public Health ndash Interactive training on vaccine administration and storage and handling handout on transporting vaccine and how to package wwwezizorg
IPI Advisor Manual | February 2017 Page 53
IPI Advisor Resource List Chapter 5
CDC vaccine price list wwwcdcgovvaccinesprogramsvfcawardeesvaccine-managementprice-listindexhtml
Vaccine Information Statements (VIS) wwwcdcgovvaccineshcpvisindexhtml
CEU Opportunities CDC Immunization Education and Training wwwcdcgovvaccinesedindexhtml
Immunization You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Page 54 IPI Advisor Manual| February 2017
- Introduction
-
- Welcome to the Immunization Practice Improvement (IPI) Program
- Contact Information
-
- Chapter 1
- Requirements to Participate in the MnVFC Program
- Vaccines for Children Program
- Chapter 2
- Reimbursement for MnVFC Visits
- Types of Visits
- Your MnVFC Clinical CoordinatorPlanner
- New IPI Advisor Training Requirements
- Your Role as an IPI Advisor
- Reasons MDH Would Do All or Part of a Visit
- Chapter 3
- Future follow-up
- Conducting the Visit
- Preparing for the Visit
- Information for the Visit
- Site Visit Checklist
- Scheduling the Visit
- Chapter 4
- After the Site Visit
- MnVFC Provider Follow-up Plan
- MnVFC Site Visit Storage and Handling Per Unit Answer Sheet
- Section 6 Inventory
- Section 5 Storage amp Handling Site-Wide
- Section 4 Storage amp Handling Per Unit
- Section 3 Documentation
- Section 2 Eligibility
- Section 1 Provider Details
- The Site Visit Reviewer Legend
- MnVFC Site Visit Questionnaire
- Required Paperwork for Site Visits
- Chapter 5
-
IPI Advisor Manual | February 2017 Page 39
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 484 Storage amp Handling Per Unit Temperature Excursions
Question 48 In the event that a temperature excursion(s) occurred in this unit within the last three months requestand review documentation of actions taken to determine whether the provider has a process for properlyaddressing excursions Answer the questions below
A Were vaccines in this unit exposed to out-of-range temperatures in the lastthree months (including today)
Yes No (If no skip to question 49)
B Did the provider quarantine and label vaccines as ldquoDo not userdquo Yes No [X]
C Did the provider place vaccine in a unit where it can be stored under properconditions if applicable
Yes No [X]
D Did the provider contact the Immunization Program to report theexcursion
Yes No [X]
E Was the manufacturer contacted for documentation supporting theusability of the vaccine
Yes No [X]
Review CDC Requirement
The provider must document all excursions and actions taken including the following (1) Quarantine and label vaccines as ldquoDO NOTUSErdquo (2) Place vaccines in a unit where they can be stored under proper conditions (3) Contact the Immunization Program to report an excursion and (4) Contact the vaccine manufacturer to obtain documentation supporting the usability of the vaccine
Goal of this question Address any out-of-range temperatures (temperature excursions) identified in reviewing the last three months of temperature logs or during the site visit If there were any out-of-range temperatures did the site respond appropriately to the situation This is a great opportunity to discuss what to do in the event of an excursion The Clinicians Storage and Handling Mishap Checklist is in the IPI Site Visit information folder and is a good review of the process
Helpful information bull Sites need to know that an excursion does not automatically mean that exposed vaccines are non-viable or unusable Exposed vaccines must be quarantined (marked ldquoDo Not Userdquo) and stored under proper conditions until they have received information from vaccine manufacturers regarding the viability of the vaccine
bull Sites must inform MDH when an excursion occurs
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Clinicians Storage and Handling Mishap Checklist (wwwhealthstatemnusdivsidepcimmunize ipivaxchklstpdf)
Page 40 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 49
Goal of this question Ensure proper placement of vaccines in the storage unit
Note These are all recommendations (best practices) not requirements
Helpful information bull Store vaccine in the middle of the compartment two to three inches away from the coils walls floor and cold air vent The temperature near the floor and walls of the unit differs from that in the middle of the compartment and the cold air vent can freeze refrigerated vaccines
4 Storage amp Handling Per Unit Vaccine Placement
Question 49 Look inside the unit to answer the questions below
A Are vaccines placed in the middle of the unit with space between vaccinesand the sideback of the unit to allow cold air to circulate
Yes No [O]
B Are vaccines stored in their original packages Yes No [O]
C Are there water bottles (for refrigerators) or frozen water bottles (forfreezers) in the unit
Yes No [O]
D Are vaccines store in the doors vegetable bins under or near cooling ventsor on the floor of the unit
Yes [O] No
E Is food being stored in the unit Yes [O] No
Review CDC Recommendation
Vaccines should be stored in their original manufacturer (or CDC centralized distributor) packaging They should be placed in the middle of the unit with space between the vaccines and the sideback of the unit to allow cold air to circulate Vaccines SHOULD NOT be stored in the doors vegetable bins or floor of the unit or under or near cooling vents and there should not be any food inthe unit Water bottles (for refrigerators) or frozen water bottles (for freezers) should be placed throughout each storage unit inorder to (1) stabilize or extend temperatures during a power outage and (2) to serve as physical blocks preventing the placementof vaccines in areas of the unit that are at higher risk for temperature excursions (such as in doors vegetable bins floor ornearunder cooling vents)
bull Vaccines should be kept in their original packaging to Protect them from light Help prevent medication errors by making labels easier to read Provide a moisture barrier that serves as insulation in case of an out-of-range temperature power outage door left open or mechanical failure Simplify managing vaccine inventory
bull Store water bottles in the doors on the floor and near the cold air vent in the refrigerator and frozen water bottles in the freezer to help maintain a stable temperature if there is a power failure and when the door is opened frequently Too many water bottles in the door can prevent the door from closing tightly Mark water bottles ldquoDo Not Drinkrdquo
bull Do not store vaccine in the door or drawers of the refrigerator or freezer Vegetable bins and crisper drawers should be removed from refrigerators or used to store other medical supplies or water bottles
bull If vaccine is stored in a household combination refrigeratorfreezer The top shelf should not be used for storing vaccine because the cold air vent blowing from the freezer will freeze vaccine located there If you must use the top shelf of this type of unit place water bottles underneath the cold air vent to prevent vaccine from being stored there It is recommended that only the refrigerator be used for vaccine storage and a separate stand-alone freezer be used to store frozen vaccine
bull Must not store food or beverages in the refrigerator or freezer because frequent opening of doors can lead to temperature variations that may affect vaccine viability There is also a risk of contaminating vaccines
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Guide (wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml) bull Vaccine Storage Tip Sheet on IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml)
IPI Advisor Manual | February 2017 Page 41
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 4104 Storage amp Handling Per Unit Disconnection from Power Source
Question 410 Ask the provider to demonstrate what measures are taken to ensure that vaccine storage units are notaccidentally physically disconnected from the power supply Which of the following describes the measure(s) taken on this unit
Note to Reviewer bull Large hospitals and healthcare systems may not have the ability to demonstrate labels on plugs or circuitbreakers In such cases verify that the practice has a comprehensive policy and standard operatingprocedures in place to prevent the vaccine storage unit from being physically disconnected from thepower supply
bull While back-up generators may ensure power to the overall facility this question ONLY addresses thevaccine storage unit being accidentally disconnected from the power source either through the plug orthe circuit breaker
Answers A ldquoDo not disconnectrdquo labels on the plug (Choose all that B ldquoWarningrdquo label on the circuit breaker box
apply) C Hard-wired (ie built-in) and has a ldquoDo not disconnectrdquo label on thecircuit breaker box D Hospital or large health care system with a comprehensive written policyand standard operating procedures detailing measures taken to preventvaccine storage units from being accidentally disconnected from the powersupply E No acceptable measures for preventing accidental disconnection frompower supply [X]
[X] The response is non-compliant if only A only B or E is selected
Review CDC Requirement
VFC providers must take steps to protect the power source for all vaccine storage equipment by means of having clear warninglabels on both the plug and the circuit breaker associated with all vaccine storage units Large hospitals and healthcare systems canmeet this requirement by demonstrating that they have comprehensive policies and standard operating procedures to preventvaccine storage units from being physically disconnected from the power supply
Goal of this question Decrease the chance that a vaccine storage unit will be accidently unplugged or power will be turned off while vaccine is in the unit This question addresses only what measures the site has taken to ensure the storage unit is not physically disconnected from its power source
If the site uses labels on the plugs and circuit breakers perform a visual inspection to assess whether the way the stickers are positioned make it clear and obvious to anyone that these units are not to be disconnected
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Do Not Unplug and Warning stickers are included in the folder or available to order on the For
Professionals Order Form (wwwhealthstatemnusdivsidepcimmunizeordermathtml)
Note Once you have completed the 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet for each unit return to the questionnaire to complete sections 5 and 6
Page 42 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
- -
Section 5 Storage amp Handling Site-Wide Question 51
5 Storage amp Handling Site Wide Discussion of Cost amp Quantity of Vaccine
Question 51 Have a discussion with the provider about the cost and quantity of VFC vaccines they are responsible for annually Address the points listed in the note to reviewer below
Note to Reviewer bull Vaccine Shipped (Required) Share the cost of VFC vaccines shipped to the provider in the last calendaryear to make sure the provider understands the contribution made by the VFC Program to their practiceFor new providers who do not have ldquocalendar yearrdquo data share either the actual cost of their currentinventory or use the cost of 10 VFC doses of each of the ACIP-recommended vaccines (approximately $7000) to help estimate their annual cost
bull Storage amp Handling (Required) Make sure the provider understands the cost of vaccines for which they are responsible when they make decisions about purchasing recommended vaccine storage and temperature monitoring equipment
Answer I have discussed with the provider the cost and quantity of vaccines ordered in the previous calendar year
Goal of this question Inform sites of the quantity and value of vaccines that they receive as part of the MnVFC program Providers often donrsquot realize the value of the vaccine in their unit This information is included on your clinic list and on the one page site-specific information
Helpful information bull This discussion must occur and the box on the questionnaire must be checked bull If there isnrsquot actual vaccine value information available tell the site that one vaccine order that includes a box of each of the ACIP recommended vaccines costs approximately $7000
bull MDH may not have specific information for individual sites if they receive vaccine from a central warehouse or pharmacy For those sites MDH will give you numbers for the whole system so you can discuss system wide data as appropriate If individual site information is also included it is usually just varicella-containing vaccines that must be shipped directly to the site
Question 52
5 Storage amp Handling Site Wide Dorm Style Units
Question 52 Determine whether the provider has any dorm-style units on site and answer the questions below
Note to Reviewer A dormitory-style refrigerator is a unit that has both refrigerator and freezer compartments behind a singleexterior door Dorm-style units also have an evaporator plate (cooling coil) which is usually located insidean icemaker compartment (freezer) within the refrigerator
A Does the provider have any dorm-style units that are used at any time tostore vaccines
Yes [X] No (Skip to question 53)
B Does the provider have sufficient space in existing compliant vaccinestorage units to store all vaccines without use of the dorm-style unit at any time
Yes No [X]
Review CDC Requirement
Dorm- and bar-style units are prohibited for vaccine storage Vaccines stored in dorm-style units are considered non-viable and must be returned to the centralized distributor CDC recommends the following vaccine storage unit types (in order of preference)pharmaceutical grade stand-alone or combination units (preferred) householdcommercial stand-alone unitshouseholdcommercial combination units using the refrigerator section only
Goal of this question Ensure no vaccine is stored in dorm-style units even for short periods of time Encourage them to label any units ldquoNo Vaccine Storage Allowedrdquo Vaccine stored in these units is considered non-viable If a site is using a dorm-style unit call the MnVFC program (651-201-5522)
Resource Section 8 in the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 43
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 535 Storage amp Handling Site Wide Storage Unit Space Availability
Question 53 Does the provider have sufficient room across storage units to store current stock as well as anyadditional stock acquired during peak season without overcrowding
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have sufficient storage space to accommodate vaccine stock at the busiest time of year without overcrowding
Goal of this question Ensure that sites have sufficient space in their units to maintain vaccines at the busiest time of year Overcrowding of vaccine limits air circulation and affects the unitrsquos ability to maintain stable temperatures
Helpful information bull Look for signs of overcrowding such as vaccines that are pushed up against the wall bins that are overflowing or storage units that are full during non-peak seasons
Discuss immediate actions if the unit is overcrowded Move some of their vaccines order less vaccine more frequently (once per month preferably) andor purchase another storage unit for overflow
Resource bull Section 8 MnVFC Policy and Procedure Manual
Page 44 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 545 Storage amp Handling Site Wide Expired Vaccines
Question 54 Look in each unit Are there expired vaccines in any of the vaccine storage units at this site
Answers (Choose one)
Yes [X] No
Review CDC Requirement
Vaccines should be rotated weekly and when a new shipment comes in so that longer-dated vaccines are stored behind shorter-dated vaccines If vaccines expire they can no longer be stored in the same storage unit with viable vaccines They must be placedin a container or bag clearly labeled ldquoDo not userdquo and separated from viable vaccines to prevent inadvertent use Expired vaccinemust be returned to the centralized distributor within six months of expiration
Goal of this question Ensure there is no expired vaccine in any storage unit
Helpful information bull Sites can prevent their stock from expiring by rotating vaccines every week andor when a new shipment arrives Longer-dated vaccines are stored towards the back of the unit and shorter-dated vaccines are up front
bull Pay attention to vaccines that expire within the next three months Consider transferring vaccine that will expire soon to another MnVFC-enrolled site that will use the vaccine preferably a site close by It is the transferring sitersquos responsibility to arrange the transfer of the vaccine Be sure to complete the MDH Vaccine Transfer Record form and send it to MDH If they are having difficulty finding a location to accept vaccine contact MDH
bull This is a great opportunity to educate sites about the MDH Nonviable Vaccine Form and the process for returning vaccine The VFC program does get some credit for taxes and fees on vaccine that is returned to the distribution center
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MDH Nonviable Vaccine Form and MDH Vaccine Transfer Record on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfcformshtml)
IPI Advisor Manual | February 2017 Page 45
The 2017 MnVFC Site Visit Paperwork Chapter 4
- -
-
Question 555 Storage amp Handling Site Wide Back up Thermometer
Question 55 Does the provider have a readily available back-up thermometer with a current and valid certificate ofcalibration testing
Note to Reviewer ldquoReadily availablerdquo means that the thermometer is available to perform twice-a-day monitoring for a unit asrequired CDC recommends that the back-up thermometer be maintained on site
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have a readily available back-up thermometer with a current and valid certificate of calibration testing Toprevent the certificates of calibration testing of the primary and back-up thermometers from expiring at the same time the date of calibration testing (or issue date) of the back-up thermometer should be different from the date of calibration testing (or issue date) of the primary thermometer As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meetsVFC program requirements
Goal of this question Ensure sites have one calibrated back-up thermometer onsite that is readily available in the event that the temperature monitoring device in unit fails transportation of vaccine is needed or there are other unexpected circumstances
Helpful information bull As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meets VFC Program requirements
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 56 5 Storage amp Handling Site Wide Preparation of Vaccine
Question 56 When does this provider prepare vaccine for administration to the patient
Note to Reviewer For mass vaccination clinics if one type of vaccine is offered providers may pre-draw up to 10 doses Ifusing pre-filled syringes pre-drawing also means activating the syringe by removing the needle guard orattaching a needle
Answers (Choose all that
apply)
Prepare dose immediately before administration Pre-draw doses for upcoming patients (in a regular clinicpractice) [O] Pre-draw up to 10 doses (in a mass-vaccination clinic) Pre-draw more than 10 doses (in a mass-vaccination clinic) [O] Other [O]
Review CDC Recommendation
CDC recommends preparing vaccines immediately prior to administration in order to assure viability of vaccine and prevent vaccinewastage Vaccines that are not administered immediately are at risk of exposure to temperatures outside of the required rangewhich can affect vaccine viability and ultimately can leave children unprotected against vaccine-preventable diseases
Goal of this question Discuss proper timing and preparation of vaccine(s) for administration These are recommendations not requirements
Helpful information bull Educate staff on the importance of preparing vaccine immediately before administration Pre-drawing of vaccines may lead to concerns related to vaccine viability potency sterility and wastage
Page 46 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 6 Inventory Question 61
6 Inventory Inventory Comparison
Question 61 Visually inspect storage units to determine if existing supply of vaccines proportionately mirrorspopulations served Choose the most accurate statement below
Note to Reviewer bull CDC recommends that providers maintain a four-week supply of inventory bull For this question do not take into account vaccine types that the provider does not order Here simply
make sure that overall the vaccines in the providerrsquos storage units are available in sufficient amounts toserve their patient population
Answers (Choose one)
The current vaccine inventory proportionately reflects the populations identified Only public stock is insufficient [X] Only private stock is insufficient [X] Both public and private stock are insufficient [X] Site uses the replacement method but does not appear to have enough vaccine for their population [X] Other [X]
Review CDC Requirement
VFC providers must order and stock routine vaccines in accordance with their patient population in order to prevent missedvaccination opportunities Having sufficient amounts of all stocks prevents the inadvertent use of VFC vaccines for non-VFC-eligiblepatients and vice versa
Goal of this question Assess whether the site is ordering appropriate quantities of vaccine for the population they serve at their site
Helpful information bull If the site sees 30 percent private-pay patients and 70 percent VFC the stock in their storage units should reflect that proportion If you donrsquot know you can ask the site about their population
bull This is meant to be a general assessment so in a big site if they have only a small amount of vaccine that may indicate an issue with vaccine management
bull CDC recommends smaller more frequent orders (ie monthly) rather than large orders to minimize the amount of vaccine loss if an incident occurs during shipment or in the storage unit Sites should not order more frequently than once a month
bull Sites using the replacement method will only have one stock but it should appear to be large enough for their population
bull Only assess the vaccine types that the site currently stocks in their unit We know there are sites that do not offer all ACIP-recommended vaccines for various reasons That issue will be addressed in question 62
IPI Advisor Manual | February 2017 Page 47
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 626 Inventory ACIP Recommended Vaccines
Question 62 Review providerrsquos current inventory to answer the questions below
A Does the provider offer all routine ACIP-recommendedvaccines for their patient population
Yes (Skip to question C) No [X] Offers all except varicella because direct ship ofvaccine is unavailable from manufacturer
B Which routine vaccines are NOT being offered DTaP Hepatitis A Hepatitis B HIB HPV Influenza Meningococcal
MMR Pneumococcal Polio Rotavirus TdapTd Varicella
C According to Immunization Program Policy does theprovider make accessible all non-routine ACIP-recommended vaccines for those VFC patients whomeet the criteria for receiving them
Yes (Skip to question 63) No [X]
D Which non-routine vaccines are NOT being offered Pneumococcal polysaccharide vaccine (PPSV23) Meningococcal Group B (MenB) Other
Review CDC Requirement
VFC providers agree to comply with immunization schedules dosages and contraindications that are established by the Advisory Committee on Immunization Practices (ACIP) for the vaccines identified and agreed upon in the Provider Agreement UNLESS bull In the VFC providers medical judgment and in accordance with accepted medical practice the VFC provider deems such
compliance to be medically inappropriate for the child bull The particular requirements contradict state law including laws pertaining to religious and other exemptions The VFC program entitles children to the following vaccines DTaP Hepatitis A Hepatitis B HIB HPV Influenza MeningococcalMMR Pneumococcal Polio Rotavirus TdapTd and Varicella VFC providers are also required to ensure that VFC-eligible children have access to non-routine vaccines as needed
Goal of this question Assess if the site is offering all the ACIP-recommended vaccines for the population they serve and these vaccines are in stock on the day of the visit It is important that every MnVFC-eligible child that comes to a providerrsquos office for an immunization is vaccinated
Helpful information bull The Advisory Committee on Immunization Practices (ACIP) is a group of medical and public health experts that develops recommendations on how to use vaccines to control diseases in the United States
bull Specialty providers are not required to offer all routine vaccines but should provide the vaccines appropriate for their population
bull If the site does not offer all routine ACIP-recommended vaccines appropriate for their population check the ldquoNordquo box in Part A then check the appropriate box(es) in Part B for any vaccines not offered Please contact MDH as this situation offers us the opportunity to provide education to the site
bull For non-routine vaccines they must either be in stock or the site must have an alternative protocol in the routine management plan that ensures these children have access when applicable
Resources bull IAC Diseases and Vaccines (wwwimmunizeorgvaccines) bull CDC Advisory Committee on Immunization Practices (ACIP) (wwwcdcgovvaccinesacipindexhtml)
Page 48 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 636 Inventory Separation of Stock
Question 63 Observe how the provider differentiates stock in each storage unit to answer the questions below
A Is it clear which vaccines belong to public stock andwhich belong to private stock
Yes No [X] Not applicable replacement site
B Is it clear which vaccines belong to VFC stock andwhich belong to UUAV stock
Yes No [X] Not applicable replacement site Not applicable not UUAV-enrolled site
Review CDC Requirement
In order to ensure that VFC vaccines are only administered to VFC-eligible children VFC providers that serve both VFC and non-VFCshyeligible children must maintain their vaccine inventories in such a way that they can clearly differentiate public stock from privatestock as well as VFC from other public stock
Goal of this question Assess whether the site can distinguish between MnVFC vaccine and private vaccine If they participate in the Uninsured and Underinsured Adult Vaccine (UUAV) program they should also be able to distinguish between MnVFC stock and UUAV stock Some sites use labels bins boxes etc to differentiate their stock If it is not clear how the site differentiates their stock discuss vaccine management with the staff For follow-up call MDH to discuss doing a follow-up site visit
Sites using the replacement method will not have separate stocksmdashthis is an approved alternative method for keeping track of vaccine
Resource bull Section 10 of the MnVFC Policy and Procedure Manual
IPI Advisor Manual | February 2017 Page 49
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
MnVFC Site Visit Storage and Handling Per Unit Answer Sheet 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet MnVFC PIN ___________________
Question number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
Temperature Monitoring Device Questions Questions 43 47 must be answered separately for the freezer and refrigerator if the unit is a combo Be sure to document responses in the appropriate column
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
All the questions on the Site Visit Storage amp Handling Per Unit Answer Sheet have been discussed previously in section 4 of this manual Use this sheet to record information about all the units at the site visit You will need one sheet for each unit If it is a combination unit (either pharmaceutical or household) you can record both sections on one sheet If they have stand-alone units use one sheet for each unit Do not enter the answers to the questions in section 4 of the questionnaire
If you need more information about any of the questions refer back to the main questionnairemdashthe complete question additional guidance including notes to the reviewer and the CDC requirements are there Also if the site is not meeting the requirement you will go back to the questionnaire to complete the ldquoActions if Non-compliantrdquo section including the root cause analysis and follow-up sections
When you have completed the assessment of all the storage units remember to go back to the questionnaire to complete sections 5 and 6
Page 50 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
ndash
ndash
MnVFC Provider Follow-up PlanThe goal of the Provider Follow-up Plan is to communicate with the site all of the VFC requirements any unmet requirements found during your site visit and the timeline for completing the required action The left hand column is a box to check for ldquoUnmetrdquo requirements
Helpful information bull The form can be used to review what the site is doing well and what they need to work on
bull For requirements that have specific documentation that needs to be sent to you use the notes section
2017 MnVFC Provider Follow-up Plan Site _______________________________________________ MnVFC PIN ____________ Date of Visit ___________
Thank you for participating in this MnVFC compliance site visit Please review this visit summary including follow-up actions and timelines for completion Unmet MnVFC requirements and recommendations have a checked box next to them The goal of this plan is to support you with successfully implementing the program and improving access to vaccines for VFC-eligible children
Unmet Question VFC Requirements Section 1 Changes to Key Staff
Q12 Change in the Medical Director Immunization Manager Vaccine Coordinator or back-upKey Staff must be communicated to the immunization program by emailing healthmnvfcstatemnus Changes Notes
Q12 Key staff must complete the annual training on VFC program requirements and print theAnnual Training certificate of completion Documentation Required Action
Staff that have not completed the MnVFC online training must complete it and send acopy of the certificate to the reviewer Training can be found on the MnVFC website (wwwhealthstatemnusvfc) Due date 1 month
Notes
Unmet Question VFC Requirements Section 2 Eligibility
Q21 Provider staff must possess a working knowledge of all VFC eligibility criteria and use thoseVFC Eligibility criteria to screen children prior to administering VFC vaccines
Categories Notes
bull This form provides documentation needed for follow-up actions when you send your thank you email
The second to last page of the Provider Follow-up Plan has a summary of the MnVFC program recommendations These are to remind the site about best practices they may want to improve upon even though they are not yet requirements of the program For example you could discuss the recommendation about storage units if they currently have a combination household unit and are using both sections
The last section is for your signature and the person you met with In most sites it will be the immunization manager or vaccine coordinator who signs the form unless the medical director attended the site visit You keep the original copy and the site will need to keep a copy for themselves
To be completed by the site visit reviewer
I acknowledge that a VFC site visit was performed on __________________ (visit date) The follow-up plan which includes a list of all current VFC program requirements and recommendations assessed during the visit and any required follow-up actions was provided at the end of the visit
Site visit reviewer
Phone
Reviewer Signature Date
To be completed by the provider
I acknowledge that our practice took part in the VFC site visit noted above I understand the findings of the visit and any required actions that must be taken by our office in order to meet VFC program requirements
Medical Director (or designee) Name Title
Medical Director (or designee) Signature Date
IPI Advisor Manual | February 2017 Page 51
The 2017 MnVFC Site Visit Paperwork Chapter 4
After the Site Visit Send a thank you email highlighting the unmet requirements documents you need from the site to resolve the issue(s) and the date you need them Make sure to include the link to the Site Visit Survey (httpssurveyvovicicomseashxs=56206EE334CE0B14)
Please refer to Chapter 3 for more information about future follow-up required after the visit including forms and documentation
Resource bull Sample Thank You letter on IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml)
Chapter 5
IPI Advisor Resource List MnVFC Program 651-201-5522
MnVFC wwwhealthstatemnusvfc
bull Separate Stock and Replacement Method Policies and Procedures Manuals bull Online trainings bull MnVFC Announcements sign up to receive them via email bull Ordering MDH vaccine bull MnVFC forms Screening forms Reporting forms Others MDH Nonviable Vaccine Form MDH Vaccine Transfer Record and Vaccine Borrowing Report
bull MnVFC promotional materials bull Immunization Billing Guidance for MnVFC and Immunization Billing Guidance for MnVFC Replacement Sites Immunization Practices Improvement Program (IPI) wwwhealthstatemnusdivsidepcimmunizeipi
bull IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml) bull IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml) IPI Resource Folder Contents (wwwhealthstatemnusdivsidepcimmunizeipiipifolderpdf)
Minnesota Immunization Information Connection (MIIC) wwwhealthstatemnusmiic
bull MIIC regions and regional coordinators
Clinical Practice MDH Immunization Program wwwhealthstatemnusimmunize
Got Your Shots News wwwhealthstatemnusdivsidepcnewslettersgys
MDH Immunization Information for Health Care Providers wwwhealthstatemnusdivsidepcimmunizehcp
bull Got Your Shots A Providers Guide to Immunization in Minnesota bull Vaccine protocols bull Forms for tracking patient immunizations bull Immunization schedules for Health Care Providers Immunization Action Coalition (IAC) wwwimmunizeorg
bull Ask the Experts bull VISs (Vaccine Information Statements and translations) bull Administration screening questions bull Medical management of vaccine reactions bull Order form for Californiarsquos Immunization Technique DVD Best Practices with Infants Children and Adults
Page 52 IPI Advisor Manual| February 2017
IPI Advisor Resource List Chapter 5
CDC ldquoPink Bookrdquo wwwcdcgovvaccinespubspinkbookindexhtml
CDC Advisory Committee on Immunization Practices (ACIP) wwwcdcgovvaccinesacip
CDC Vaccines and Immunizations wwwcdcgovvaccines
VAERS reporting httpvaershhsgovindex
Storage and Handling Got Your Shots Providers Guide ndash Managing Vaccine wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml
MnVFC Guide to Temperature Monitoring Devices wwwhealthstatemnusvfc
MDH Clinicianrsquos Vaccine Mishap Checklist wwwhealthstatemnusdivsidepcimmunizeipivaxchklstpdf
MDH Vaccine Storage Guide wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml
CDC Vaccine Storage and Handling Toolkit wwwcdcgovvaccinesrecsstoragetoolkit
You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Vaccine manufacturer phone numbers wwwcdcgovvaccinespubspinkbookdownloadsappendicesFcontact-info-manufactpdf
IAC Checklist for Safe Vaccine Handling and Storage wwwimmunizeorgcatgdp3035pdf
IAC Donrsquot Be Guilty of These Errors in Vaccine Storage and Handling wwwimmunizeorgcatgdp3036pdf
Additional Resources Print materials from MDH ndash order forms wwwhealthstatemnusdivsidepcimmunizeordermathtml
Vaccine Education Center ndash Childrenrsquos Hospital of Philadelphia wwwchopeduservicevaccine-education-centerhomehtml
California Department of Public Health ndash Interactive training on vaccine administration and storage and handling handout on transporting vaccine and how to package wwwezizorg
IPI Advisor Manual | February 2017 Page 53
IPI Advisor Resource List Chapter 5
CDC vaccine price list wwwcdcgovvaccinesprogramsvfcawardeesvaccine-managementprice-listindexhtml
Vaccine Information Statements (VIS) wwwcdcgovvaccineshcpvisindexhtml
CEU Opportunities CDC Immunization Education and Training wwwcdcgovvaccinesedindexhtml
Immunization You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Page 54 IPI Advisor Manual| February 2017
- Introduction
-
- Welcome to the Immunization Practice Improvement (IPI) Program
- Contact Information
-
- Chapter 1
- Requirements to Participate in the MnVFC Program
- Vaccines for Children Program
- Chapter 2
- Reimbursement for MnVFC Visits
- Types of Visits
- Your MnVFC Clinical CoordinatorPlanner
- New IPI Advisor Training Requirements
- Your Role as an IPI Advisor
- Reasons MDH Would Do All or Part of a Visit
- Chapter 3
- Future follow-up
- Conducting the Visit
- Preparing for the Visit
- Information for the Visit
- Site Visit Checklist
- Scheduling the Visit
- Chapter 4
- After the Site Visit
- MnVFC Provider Follow-up Plan
- MnVFC Site Visit Storage and Handling Per Unit Answer Sheet
- Section 6 Inventory
- Section 5 Storage amp Handling Site-Wide
- Section 4 Storage amp Handling Per Unit
- Section 3 Documentation
- Section 2 Eligibility
- Section 1 Provider Details
- The Site Visit Reviewer Legend
- MnVFC Site Visit Questionnaire
- Required Paperwork for Site Visits
- Chapter 5
-
Page 40 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 49
Goal of this question Ensure proper placement of vaccines in the storage unit
Note These are all recommendations (best practices) not requirements
Helpful information bull Store vaccine in the middle of the compartment two to three inches away from the coils walls floor and cold air vent The temperature near the floor and walls of the unit differs from that in the middle of the compartment and the cold air vent can freeze refrigerated vaccines
4 Storage amp Handling Per Unit Vaccine Placement
Question 49 Look inside the unit to answer the questions below
A Are vaccines placed in the middle of the unit with space between vaccinesand the sideback of the unit to allow cold air to circulate
Yes No [O]
B Are vaccines stored in their original packages Yes No [O]
C Are there water bottles (for refrigerators) or frozen water bottles (forfreezers) in the unit
Yes No [O]
D Are vaccines store in the doors vegetable bins under or near cooling ventsor on the floor of the unit
Yes [O] No
E Is food being stored in the unit Yes [O] No
Review CDC Recommendation
Vaccines should be stored in their original manufacturer (or CDC centralized distributor) packaging They should be placed in the middle of the unit with space between the vaccines and the sideback of the unit to allow cold air to circulate Vaccines SHOULD NOT be stored in the doors vegetable bins or floor of the unit or under or near cooling vents and there should not be any food inthe unit Water bottles (for refrigerators) or frozen water bottles (for freezers) should be placed throughout each storage unit inorder to (1) stabilize or extend temperatures during a power outage and (2) to serve as physical blocks preventing the placementof vaccines in areas of the unit that are at higher risk for temperature excursions (such as in doors vegetable bins floor ornearunder cooling vents)
bull Vaccines should be kept in their original packaging to Protect them from light Help prevent medication errors by making labels easier to read Provide a moisture barrier that serves as insulation in case of an out-of-range temperature power outage door left open or mechanical failure Simplify managing vaccine inventory
bull Store water bottles in the doors on the floor and near the cold air vent in the refrigerator and frozen water bottles in the freezer to help maintain a stable temperature if there is a power failure and when the door is opened frequently Too many water bottles in the door can prevent the door from closing tightly Mark water bottles ldquoDo Not Drinkrdquo
bull Do not store vaccine in the door or drawers of the refrigerator or freezer Vegetable bins and crisper drawers should be removed from refrigerators or used to store other medical supplies or water bottles
bull If vaccine is stored in a household combination refrigeratorfreezer The top shelf should not be used for storing vaccine because the cold air vent blowing from the freezer will freeze vaccine located there If you must use the top shelf of this type of unit place water bottles underneath the cold air vent to prevent vaccine from being stored there It is recommended that only the refrigerator be used for vaccine storage and a separate stand-alone freezer be used to store frozen vaccine
bull Must not store food or beverages in the refrigerator or freezer because frequent opening of doors can lead to temperature variations that may affect vaccine viability There is also a risk of contaminating vaccines
Resources bull Section 9 in the MnVFC Policies and Procedures Manual bull Vaccine Storage Guide (wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml) bull Vaccine Storage Tip Sheet on IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml)
IPI Advisor Manual | February 2017 Page 41
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 4104 Storage amp Handling Per Unit Disconnection from Power Source
Question 410 Ask the provider to demonstrate what measures are taken to ensure that vaccine storage units are notaccidentally physically disconnected from the power supply Which of the following describes the measure(s) taken on this unit
Note to Reviewer bull Large hospitals and healthcare systems may not have the ability to demonstrate labels on plugs or circuitbreakers In such cases verify that the practice has a comprehensive policy and standard operatingprocedures in place to prevent the vaccine storage unit from being physically disconnected from thepower supply
bull While back-up generators may ensure power to the overall facility this question ONLY addresses thevaccine storage unit being accidentally disconnected from the power source either through the plug orthe circuit breaker
Answers A ldquoDo not disconnectrdquo labels on the plug (Choose all that B ldquoWarningrdquo label on the circuit breaker box
apply) C Hard-wired (ie built-in) and has a ldquoDo not disconnectrdquo label on thecircuit breaker box D Hospital or large health care system with a comprehensive written policyand standard operating procedures detailing measures taken to preventvaccine storage units from being accidentally disconnected from the powersupply E No acceptable measures for preventing accidental disconnection frompower supply [X]
[X] The response is non-compliant if only A only B or E is selected
Review CDC Requirement
VFC providers must take steps to protect the power source for all vaccine storage equipment by means of having clear warninglabels on both the plug and the circuit breaker associated with all vaccine storage units Large hospitals and healthcare systems canmeet this requirement by demonstrating that they have comprehensive policies and standard operating procedures to preventvaccine storage units from being physically disconnected from the power supply
Goal of this question Decrease the chance that a vaccine storage unit will be accidently unplugged or power will be turned off while vaccine is in the unit This question addresses only what measures the site has taken to ensure the storage unit is not physically disconnected from its power source
If the site uses labels on the plugs and circuit breakers perform a visual inspection to assess whether the way the stickers are positioned make it clear and obvious to anyone that these units are not to be disconnected
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Do Not Unplug and Warning stickers are included in the folder or available to order on the For
Professionals Order Form (wwwhealthstatemnusdivsidepcimmunizeordermathtml)
Note Once you have completed the 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet for each unit return to the questionnaire to complete sections 5 and 6
Page 42 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
- -
Section 5 Storage amp Handling Site-Wide Question 51
5 Storage amp Handling Site Wide Discussion of Cost amp Quantity of Vaccine
Question 51 Have a discussion with the provider about the cost and quantity of VFC vaccines they are responsible for annually Address the points listed in the note to reviewer below
Note to Reviewer bull Vaccine Shipped (Required) Share the cost of VFC vaccines shipped to the provider in the last calendaryear to make sure the provider understands the contribution made by the VFC Program to their practiceFor new providers who do not have ldquocalendar yearrdquo data share either the actual cost of their currentinventory or use the cost of 10 VFC doses of each of the ACIP-recommended vaccines (approximately $7000) to help estimate their annual cost
bull Storage amp Handling (Required) Make sure the provider understands the cost of vaccines for which they are responsible when they make decisions about purchasing recommended vaccine storage and temperature monitoring equipment
Answer I have discussed with the provider the cost and quantity of vaccines ordered in the previous calendar year
Goal of this question Inform sites of the quantity and value of vaccines that they receive as part of the MnVFC program Providers often donrsquot realize the value of the vaccine in their unit This information is included on your clinic list and on the one page site-specific information
Helpful information bull This discussion must occur and the box on the questionnaire must be checked bull If there isnrsquot actual vaccine value information available tell the site that one vaccine order that includes a box of each of the ACIP recommended vaccines costs approximately $7000
bull MDH may not have specific information for individual sites if they receive vaccine from a central warehouse or pharmacy For those sites MDH will give you numbers for the whole system so you can discuss system wide data as appropriate If individual site information is also included it is usually just varicella-containing vaccines that must be shipped directly to the site
Question 52
5 Storage amp Handling Site Wide Dorm Style Units
Question 52 Determine whether the provider has any dorm-style units on site and answer the questions below
Note to Reviewer A dormitory-style refrigerator is a unit that has both refrigerator and freezer compartments behind a singleexterior door Dorm-style units also have an evaporator plate (cooling coil) which is usually located insidean icemaker compartment (freezer) within the refrigerator
A Does the provider have any dorm-style units that are used at any time tostore vaccines
Yes [X] No (Skip to question 53)
B Does the provider have sufficient space in existing compliant vaccinestorage units to store all vaccines without use of the dorm-style unit at any time
Yes No [X]
Review CDC Requirement
Dorm- and bar-style units are prohibited for vaccine storage Vaccines stored in dorm-style units are considered non-viable and must be returned to the centralized distributor CDC recommends the following vaccine storage unit types (in order of preference)pharmaceutical grade stand-alone or combination units (preferred) householdcommercial stand-alone unitshouseholdcommercial combination units using the refrigerator section only
Goal of this question Ensure no vaccine is stored in dorm-style units even for short periods of time Encourage them to label any units ldquoNo Vaccine Storage Allowedrdquo Vaccine stored in these units is considered non-viable If a site is using a dorm-style unit call the MnVFC program (651-201-5522)
Resource Section 8 in the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 43
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 535 Storage amp Handling Site Wide Storage Unit Space Availability
Question 53 Does the provider have sufficient room across storage units to store current stock as well as anyadditional stock acquired during peak season without overcrowding
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have sufficient storage space to accommodate vaccine stock at the busiest time of year without overcrowding
Goal of this question Ensure that sites have sufficient space in their units to maintain vaccines at the busiest time of year Overcrowding of vaccine limits air circulation and affects the unitrsquos ability to maintain stable temperatures
Helpful information bull Look for signs of overcrowding such as vaccines that are pushed up against the wall bins that are overflowing or storage units that are full during non-peak seasons
Discuss immediate actions if the unit is overcrowded Move some of their vaccines order less vaccine more frequently (once per month preferably) andor purchase another storage unit for overflow
Resource bull Section 8 MnVFC Policy and Procedure Manual
Page 44 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 545 Storage amp Handling Site Wide Expired Vaccines
Question 54 Look in each unit Are there expired vaccines in any of the vaccine storage units at this site
Answers (Choose one)
Yes [X] No
Review CDC Requirement
Vaccines should be rotated weekly and when a new shipment comes in so that longer-dated vaccines are stored behind shorter-dated vaccines If vaccines expire they can no longer be stored in the same storage unit with viable vaccines They must be placedin a container or bag clearly labeled ldquoDo not userdquo and separated from viable vaccines to prevent inadvertent use Expired vaccinemust be returned to the centralized distributor within six months of expiration
Goal of this question Ensure there is no expired vaccine in any storage unit
Helpful information bull Sites can prevent their stock from expiring by rotating vaccines every week andor when a new shipment arrives Longer-dated vaccines are stored towards the back of the unit and shorter-dated vaccines are up front
bull Pay attention to vaccines that expire within the next three months Consider transferring vaccine that will expire soon to another MnVFC-enrolled site that will use the vaccine preferably a site close by It is the transferring sitersquos responsibility to arrange the transfer of the vaccine Be sure to complete the MDH Vaccine Transfer Record form and send it to MDH If they are having difficulty finding a location to accept vaccine contact MDH
bull This is a great opportunity to educate sites about the MDH Nonviable Vaccine Form and the process for returning vaccine The VFC program does get some credit for taxes and fees on vaccine that is returned to the distribution center
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MDH Nonviable Vaccine Form and MDH Vaccine Transfer Record on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfcformshtml)
IPI Advisor Manual | February 2017 Page 45
The 2017 MnVFC Site Visit Paperwork Chapter 4
- -
-
Question 555 Storage amp Handling Site Wide Back up Thermometer
Question 55 Does the provider have a readily available back-up thermometer with a current and valid certificate ofcalibration testing
Note to Reviewer ldquoReadily availablerdquo means that the thermometer is available to perform twice-a-day monitoring for a unit asrequired CDC recommends that the back-up thermometer be maintained on site
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have a readily available back-up thermometer with a current and valid certificate of calibration testing Toprevent the certificates of calibration testing of the primary and back-up thermometers from expiring at the same time the date of calibration testing (or issue date) of the back-up thermometer should be different from the date of calibration testing (or issue date) of the primary thermometer As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meetsVFC program requirements
Goal of this question Ensure sites have one calibrated back-up thermometer onsite that is readily available in the event that the temperature monitoring device in unit fails transportation of vaccine is needed or there are other unexpected circumstances
Helpful information bull As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meets VFC Program requirements
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 56 5 Storage amp Handling Site Wide Preparation of Vaccine
Question 56 When does this provider prepare vaccine for administration to the patient
Note to Reviewer For mass vaccination clinics if one type of vaccine is offered providers may pre-draw up to 10 doses Ifusing pre-filled syringes pre-drawing also means activating the syringe by removing the needle guard orattaching a needle
Answers (Choose all that
apply)
Prepare dose immediately before administration Pre-draw doses for upcoming patients (in a regular clinicpractice) [O] Pre-draw up to 10 doses (in a mass-vaccination clinic) Pre-draw more than 10 doses (in a mass-vaccination clinic) [O] Other [O]
Review CDC Recommendation
CDC recommends preparing vaccines immediately prior to administration in order to assure viability of vaccine and prevent vaccinewastage Vaccines that are not administered immediately are at risk of exposure to temperatures outside of the required rangewhich can affect vaccine viability and ultimately can leave children unprotected against vaccine-preventable diseases
Goal of this question Discuss proper timing and preparation of vaccine(s) for administration These are recommendations not requirements
Helpful information bull Educate staff on the importance of preparing vaccine immediately before administration Pre-drawing of vaccines may lead to concerns related to vaccine viability potency sterility and wastage
Page 46 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 6 Inventory Question 61
6 Inventory Inventory Comparison
Question 61 Visually inspect storage units to determine if existing supply of vaccines proportionately mirrorspopulations served Choose the most accurate statement below
Note to Reviewer bull CDC recommends that providers maintain a four-week supply of inventory bull For this question do not take into account vaccine types that the provider does not order Here simply
make sure that overall the vaccines in the providerrsquos storage units are available in sufficient amounts toserve their patient population
Answers (Choose one)
The current vaccine inventory proportionately reflects the populations identified Only public stock is insufficient [X] Only private stock is insufficient [X] Both public and private stock are insufficient [X] Site uses the replacement method but does not appear to have enough vaccine for their population [X] Other [X]
Review CDC Requirement
VFC providers must order and stock routine vaccines in accordance with their patient population in order to prevent missedvaccination opportunities Having sufficient amounts of all stocks prevents the inadvertent use of VFC vaccines for non-VFC-eligiblepatients and vice versa
Goal of this question Assess whether the site is ordering appropriate quantities of vaccine for the population they serve at their site
Helpful information bull If the site sees 30 percent private-pay patients and 70 percent VFC the stock in their storage units should reflect that proportion If you donrsquot know you can ask the site about their population
bull This is meant to be a general assessment so in a big site if they have only a small amount of vaccine that may indicate an issue with vaccine management
bull CDC recommends smaller more frequent orders (ie monthly) rather than large orders to minimize the amount of vaccine loss if an incident occurs during shipment or in the storage unit Sites should not order more frequently than once a month
bull Sites using the replacement method will only have one stock but it should appear to be large enough for their population
bull Only assess the vaccine types that the site currently stocks in their unit We know there are sites that do not offer all ACIP-recommended vaccines for various reasons That issue will be addressed in question 62
IPI Advisor Manual | February 2017 Page 47
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 626 Inventory ACIP Recommended Vaccines
Question 62 Review providerrsquos current inventory to answer the questions below
A Does the provider offer all routine ACIP-recommendedvaccines for their patient population
Yes (Skip to question C) No [X] Offers all except varicella because direct ship ofvaccine is unavailable from manufacturer
B Which routine vaccines are NOT being offered DTaP Hepatitis A Hepatitis B HIB HPV Influenza Meningococcal
MMR Pneumococcal Polio Rotavirus TdapTd Varicella
C According to Immunization Program Policy does theprovider make accessible all non-routine ACIP-recommended vaccines for those VFC patients whomeet the criteria for receiving them
Yes (Skip to question 63) No [X]
D Which non-routine vaccines are NOT being offered Pneumococcal polysaccharide vaccine (PPSV23) Meningococcal Group B (MenB) Other
Review CDC Requirement
VFC providers agree to comply with immunization schedules dosages and contraindications that are established by the Advisory Committee on Immunization Practices (ACIP) for the vaccines identified and agreed upon in the Provider Agreement UNLESS bull In the VFC providers medical judgment and in accordance with accepted medical practice the VFC provider deems such
compliance to be medically inappropriate for the child bull The particular requirements contradict state law including laws pertaining to religious and other exemptions The VFC program entitles children to the following vaccines DTaP Hepatitis A Hepatitis B HIB HPV Influenza MeningococcalMMR Pneumococcal Polio Rotavirus TdapTd and Varicella VFC providers are also required to ensure that VFC-eligible children have access to non-routine vaccines as needed
Goal of this question Assess if the site is offering all the ACIP-recommended vaccines for the population they serve and these vaccines are in stock on the day of the visit It is important that every MnVFC-eligible child that comes to a providerrsquos office for an immunization is vaccinated
Helpful information bull The Advisory Committee on Immunization Practices (ACIP) is a group of medical and public health experts that develops recommendations on how to use vaccines to control diseases in the United States
bull Specialty providers are not required to offer all routine vaccines but should provide the vaccines appropriate for their population
bull If the site does not offer all routine ACIP-recommended vaccines appropriate for their population check the ldquoNordquo box in Part A then check the appropriate box(es) in Part B for any vaccines not offered Please contact MDH as this situation offers us the opportunity to provide education to the site
bull For non-routine vaccines they must either be in stock or the site must have an alternative protocol in the routine management plan that ensures these children have access when applicable
Resources bull IAC Diseases and Vaccines (wwwimmunizeorgvaccines) bull CDC Advisory Committee on Immunization Practices (ACIP) (wwwcdcgovvaccinesacipindexhtml)
Page 48 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 636 Inventory Separation of Stock
Question 63 Observe how the provider differentiates stock in each storage unit to answer the questions below
A Is it clear which vaccines belong to public stock andwhich belong to private stock
Yes No [X] Not applicable replacement site
B Is it clear which vaccines belong to VFC stock andwhich belong to UUAV stock
Yes No [X] Not applicable replacement site Not applicable not UUAV-enrolled site
Review CDC Requirement
In order to ensure that VFC vaccines are only administered to VFC-eligible children VFC providers that serve both VFC and non-VFCshyeligible children must maintain their vaccine inventories in such a way that they can clearly differentiate public stock from privatestock as well as VFC from other public stock
Goal of this question Assess whether the site can distinguish between MnVFC vaccine and private vaccine If they participate in the Uninsured and Underinsured Adult Vaccine (UUAV) program they should also be able to distinguish between MnVFC stock and UUAV stock Some sites use labels bins boxes etc to differentiate their stock If it is not clear how the site differentiates their stock discuss vaccine management with the staff For follow-up call MDH to discuss doing a follow-up site visit
Sites using the replacement method will not have separate stocksmdashthis is an approved alternative method for keeping track of vaccine
Resource bull Section 10 of the MnVFC Policy and Procedure Manual
IPI Advisor Manual | February 2017 Page 49
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
MnVFC Site Visit Storage and Handling Per Unit Answer Sheet 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet MnVFC PIN ___________________
Question number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
Temperature Monitoring Device Questions Questions 43 47 must be answered separately for the freezer and refrigerator if the unit is a combo Be sure to document responses in the appropriate column
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
All the questions on the Site Visit Storage amp Handling Per Unit Answer Sheet have been discussed previously in section 4 of this manual Use this sheet to record information about all the units at the site visit You will need one sheet for each unit If it is a combination unit (either pharmaceutical or household) you can record both sections on one sheet If they have stand-alone units use one sheet for each unit Do not enter the answers to the questions in section 4 of the questionnaire
If you need more information about any of the questions refer back to the main questionnairemdashthe complete question additional guidance including notes to the reviewer and the CDC requirements are there Also if the site is not meeting the requirement you will go back to the questionnaire to complete the ldquoActions if Non-compliantrdquo section including the root cause analysis and follow-up sections
When you have completed the assessment of all the storage units remember to go back to the questionnaire to complete sections 5 and 6
Page 50 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
ndash
ndash
MnVFC Provider Follow-up PlanThe goal of the Provider Follow-up Plan is to communicate with the site all of the VFC requirements any unmet requirements found during your site visit and the timeline for completing the required action The left hand column is a box to check for ldquoUnmetrdquo requirements
Helpful information bull The form can be used to review what the site is doing well and what they need to work on
bull For requirements that have specific documentation that needs to be sent to you use the notes section
2017 MnVFC Provider Follow-up Plan Site _______________________________________________ MnVFC PIN ____________ Date of Visit ___________
Thank you for participating in this MnVFC compliance site visit Please review this visit summary including follow-up actions and timelines for completion Unmet MnVFC requirements and recommendations have a checked box next to them The goal of this plan is to support you with successfully implementing the program and improving access to vaccines for VFC-eligible children
Unmet Question VFC Requirements Section 1 Changes to Key Staff
Q12 Change in the Medical Director Immunization Manager Vaccine Coordinator or back-upKey Staff must be communicated to the immunization program by emailing healthmnvfcstatemnus Changes Notes
Q12 Key staff must complete the annual training on VFC program requirements and print theAnnual Training certificate of completion Documentation Required Action
Staff that have not completed the MnVFC online training must complete it and send acopy of the certificate to the reviewer Training can be found on the MnVFC website (wwwhealthstatemnusvfc) Due date 1 month
Notes
Unmet Question VFC Requirements Section 2 Eligibility
Q21 Provider staff must possess a working knowledge of all VFC eligibility criteria and use thoseVFC Eligibility criteria to screen children prior to administering VFC vaccines
Categories Notes
bull This form provides documentation needed for follow-up actions when you send your thank you email
The second to last page of the Provider Follow-up Plan has a summary of the MnVFC program recommendations These are to remind the site about best practices they may want to improve upon even though they are not yet requirements of the program For example you could discuss the recommendation about storage units if they currently have a combination household unit and are using both sections
The last section is for your signature and the person you met with In most sites it will be the immunization manager or vaccine coordinator who signs the form unless the medical director attended the site visit You keep the original copy and the site will need to keep a copy for themselves
To be completed by the site visit reviewer
I acknowledge that a VFC site visit was performed on __________________ (visit date) The follow-up plan which includes a list of all current VFC program requirements and recommendations assessed during the visit and any required follow-up actions was provided at the end of the visit
Site visit reviewer
Phone
Reviewer Signature Date
To be completed by the provider
I acknowledge that our practice took part in the VFC site visit noted above I understand the findings of the visit and any required actions that must be taken by our office in order to meet VFC program requirements
Medical Director (or designee) Name Title
Medical Director (or designee) Signature Date
IPI Advisor Manual | February 2017 Page 51
The 2017 MnVFC Site Visit Paperwork Chapter 4
After the Site Visit Send a thank you email highlighting the unmet requirements documents you need from the site to resolve the issue(s) and the date you need them Make sure to include the link to the Site Visit Survey (httpssurveyvovicicomseashxs=56206EE334CE0B14)
Please refer to Chapter 3 for more information about future follow-up required after the visit including forms and documentation
Resource bull Sample Thank You letter on IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml)
Chapter 5
IPI Advisor Resource List MnVFC Program 651-201-5522
MnVFC wwwhealthstatemnusvfc
bull Separate Stock and Replacement Method Policies and Procedures Manuals bull Online trainings bull MnVFC Announcements sign up to receive them via email bull Ordering MDH vaccine bull MnVFC forms Screening forms Reporting forms Others MDH Nonviable Vaccine Form MDH Vaccine Transfer Record and Vaccine Borrowing Report
bull MnVFC promotional materials bull Immunization Billing Guidance for MnVFC and Immunization Billing Guidance for MnVFC Replacement Sites Immunization Practices Improvement Program (IPI) wwwhealthstatemnusdivsidepcimmunizeipi
bull IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml) bull IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml) IPI Resource Folder Contents (wwwhealthstatemnusdivsidepcimmunizeipiipifolderpdf)
Minnesota Immunization Information Connection (MIIC) wwwhealthstatemnusmiic
bull MIIC regions and regional coordinators
Clinical Practice MDH Immunization Program wwwhealthstatemnusimmunize
Got Your Shots News wwwhealthstatemnusdivsidepcnewslettersgys
MDH Immunization Information for Health Care Providers wwwhealthstatemnusdivsidepcimmunizehcp
bull Got Your Shots A Providers Guide to Immunization in Minnesota bull Vaccine protocols bull Forms for tracking patient immunizations bull Immunization schedules for Health Care Providers Immunization Action Coalition (IAC) wwwimmunizeorg
bull Ask the Experts bull VISs (Vaccine Information Statements and translations) bull Administration screening questions bull Medical management of vaccine reactions bull Order form for Californiarsquos Immunization Technique DVD Best Practices with Infants Children and Adults
Page 52 IPI Advisor Manual| February 2017
IPI Advisor Resource List Chapter 5
CDC ldquoPink Bookrdquo wwwcdcgovvaccinespubspinkbookindexhtml
CDC Advisory Committee on Immunization Practices (ACIP) wwwcdcgovvaccinesacip
CDC Vaccines and Immunizations wwwcdcgovvaccines
VAERS reporting httpvaershhsgovindex
Storage and Handling Got Your Shots Providers Guide ndash Managing Vaccine wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml
MnVFC Guide to Temperature Monitoring Devices wwwhealthstatemnusvfc
MDH Clinicianrsquos Vaccine Mishap Checklist wwwhealthstatemnusdivsidepcimmunizeipivaxchklstpdf
MDH Vaccine Storage Guide wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml
CDC Vaccine Storage and Handling Toolkit wwwcdcgovvaccinesrecsstoragetoolkit
You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Vaccine manufacturer phone numbers wwwcdcgovvaccinespubspinkbookdownloadsappendicesFcontact-info-manufactpdf
IAC Checklist for Safe Vaccine Handling and Storage wwwimmunizeorgcatgdp3035pdf
IAC Donrsquot Be Guilty of These Errors in Vaccine Storage and Handling wwwimmunizeorgcatgdp3036pdf
Additional Resources Print materials from MDH ndash order forms wwwhealthstatemnusdivsidepcimmunizeordermathtml
Vaccine Education Center ndash Childrenrsquos Hospital of Philadelphia wwwchopeduservicevaccine-education-centerhomehtml
California Department of Public Health ndash Interactive training on vaccine administration and storage and handling handout on transporting vaccine and how to package wwwezizorg
IPI Advisor Manual | February 2017 Page 53
IPI Advisor Resource List Chapter 5
CDC vaccine price list wwwcdcgovvaccinesprogramsvfcawardeesvaccine-managementprice-listindexhtml
Vaccine Information Statements (VIS) wwwcdcgovvaccineshcpvisindexhtml
CEU Opportunities CDC Immunization Education and Training wwwcdcgovvaccinesedindexhtml
Immunization You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Page 54 IPI Advisor Manual| February 2017
- Introduction
-
- Welcome to the Immunization Practice Improvement (IPI) Program
- Contact Information
-
- Chapter 1
- Requirements to Participate in the MnVFC Program
- Vaccines for Children Program
- Chapter 2
- Reimbursement for MnVFC Visits
- Types of Visits
- Your MnVFC Clinical CoordinatorPlanner
- New IPI Advisor Training Requirements
- Your Role as an IPI Advisor
- Reasons MDH Would Do All or Part of a Visit
- Chapter 3
- Future follow-up
- Conducting the Visit
- Preparing for the Visit
- Information for the Visit
- Site Visit Checklist
- Scheduling the Visit
- Chapter 4
- After the Site Visit
- MnVFC Provider Follow-up Plan
- MnVFC Site Visit Storage and Handling Per Unit Answer Sheet
- Section 6 Inventory
- Section 5 Storage amp Handling Site-Wide
- Section 4 Storage amp Handling Per Unit
- Section 3 Documentation
- Section 2 Eligibility
- Section 1 Provider Details
- The Site Visit Reviewer Legend
- MnVFC Site Visit Questionnaire
- Required Paperwork for Site Visits
- Chapter 5
-
IPI Advisor Manual | February 2017 Page 41
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 4104 Storage amp Handling Per Unit Disconnection from Power Source
Question 410 Ask the provider to demonstrate what measures are taken to ensure that vaccine storage units are notaccidentally physically disconnected from the power supply Which of the following describes the measure(s) taken on this unit
Note to Reviewer bull Large hospitals and healthcare systems may not have the ability to demonstrate labels on plugs or circuitbreakers In such cases verify that the practice has a comprehensive policy and standard operatingprocedures in place to prevent the vaccine storage unit from being physically disconnected from thepower supply
bull While back-up generators may ensure power to the overall facility this question ONLY addresses thevaccine storage unit being accidentally disconnected from the power source either through the plug orthe circuit breaker
Answers A ldquoDo not disconnectrdquo labels on the plug (Choose all that B ldquoWarningrdquo label on the circuit breaker box
apply) C Hard-wired (ie built-in) and has a ldquoDo not disconnectrdquo label on thecircuit breaker box D Hospital or large health care system with a comprehensive written policyand standard operating procedures detailing measures taken to preventvaccine storage units from being accidentally disconnected from the powersupply E No acceptable measures for preventing accidental disconnection frompower supply [X]
[X] The response is non-compliant if only A only B or E is selected
Review CDC Requirement
VFC providers must take steps to protect the power source for all vaccine storage equipment by means of having clear warninglabels on both the plug and the circuit breaker associated with all vaccine storage units Large hospitals and healthcare systems canmeet this requirement by demonstrating that they have comprehensive policies and standard operating procedures to preventvaccine storage units from being physically disconnected from the power supply
Goal of this question Decrease the chance that a vaccine storage unit will be accidently unplugged or power will be turned off while vaccine is in the unit This question addresses only what measures the site has taken to ensure the storage unit is not physically disconnected from its power source
If the site uses labels on the plugs and circuit breakers perform a visual inspection to assess whether the way the stickers are positioned make it clear and obvious to anyone that these units are not to be disconnected
Resources bull Section 8 in the MnVFC Policies and Procedures Manual bull Do Not Unplug and Warning stickers are included in the folder or available to order on the For
Professionals Order Form (wwwhealthstatemnusdivsidepcimmunizeordermathtml)
Note Once you have completed the 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet for each unit return to the questionnaire to complete sections 5 and 6
Page 42 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
- -
Section 5 Storage amp Handling Site-Wide Question 51
5 Storage amp Handling Site Wide Discussion of Cost amp Quantity of Vaccine
Question 51 Have a discussion with the provider about the cost and quantity of VFC vaccines they are responsible for annually Address the points listed in the note to reviewer below
Note to Reviewer bull Vaccine Shipped (Required) Share the cost of VFC vaccines shipped to the provider in the last calendaryear to make sure the provider understands the contribution made by the VFC Program to their practiceFor new providers who do not have ldquocalendar yearrdquo data share either the actual cost of their currentinventory or use the cost of 10 VFC doses of each of the ACIP-recommended vaccines (approximately $7000) to help estimate their annual cost
bull Storage amp Handling (Required) Make sure the provider understands the cost of vaccines for which they are responsible when they make decisions about purchasing recommended vaccine storage and temperature monitoring equipment
Answer I have discussed with the provider the cost and quantity of vaccines ordered in the previous calendar year
Goal of this question Inform sites of the quantity and value of vaccines that they receive as part of the MnVFC program Providers often donrsquot realize the value of the vaccine in their unit This information is included on your clinic list and on the one page site-specific information
Helpful information bull This discussion must occur and the box on the questionnaire must be checked bull If there isnrsquot actual vaccine value information available tell the site that one vaccine order that includes a box of each of the ACIP recommended vaccines costs approximately $7000
bull MDH may not have specific information for individual sites if they receive vaccine from a central warehouse or pharmacy For those sites MDH will give you numbers for the whole system so you can discuss system wide data as appropriate If individual site information is also included it is usually just varicella-containing vaccines that must be shipped directly to the site
Question 52
5 Storage amp Handling Site Wide Dorm Style Units
Question 52 Determine whether the provider has any dorm-style units on site and answer the questions below
Note to Reviewer A dormitory-style refrigerator is a unit that has both refrigerator and freezer compartments behind a singleexterior door Dorm-style units also have an evaporator plate (cooling coil) which is usually located insidean icemaker compartment (freezer) within the refrigerator
A Does the provider have any dorm-style units that are used at any time tostore vaccines
Yes [X] No (Skip to question 53)
B Does the provider have sufficient space in existing compliant vaccinestorage units to store all vaccines without use of the dorm-style unit at any time
Yes No [X]
Review CDC Requirement
Dorm- and bar-style units are prohibited for vaccine storage Vaccines stored in dorm-style units are considered non-viable and must be returned to the centralized distributor CDC recommends the following vaccine storage unit types (in order of preference)pharmaceutical grade stand-alone or combination units (preferred) householdcommercial stand-alone unitshouseholdcommercial combination units using the refrigerator section only
Goal of this question Ensure no vaccine is stored in dorm-style units even for short periods of time Encourage them to label any units ldquoNo Vaccine Storage Allowedrdquo Vaccine stored in these units is considered non-viable If a site is using a dorm-style unit call the MnVFC program (651-201-5522)
Resource Section 8 in the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 43
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 535 Storage amp Handling Site Wide Storage Unit Space Availability
Question 53 Does the provider have sufficient room across storage units to store current stock as well as anyadditional stock acquired during peak season without overcrowding
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have sufficient storage space to accommodate vaccine stock at the busiest time of year without overcrowding
Goal of this question Ensure that sites have sufficient space in their units to maintain vaccines at the busiest time of year Overcrowding of vaccine limits air circulation and affects the unitrsquos ability to maintain stable temperatures
Helpful information bull Look for signs of overcrowding such as vaccines that are pushed up against the wall bins that are overflowing or storage units that are full during non-peak seasons
Discuss immediate actions if the unit is overcrowded Move some of their vaccines order less vaccine more frequently (once per month preferably) andor purchase another storage unit for overflow
Resource bull Section 8 MnVFC Policy and Procedure Manual
Page 44 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 545 Storage amp Handling Site Wide Expired Vaccines
Question 54 Look in each unit Are there expired vaccines in any of the vaccine storage units at this site
Answers (Choose one)
Yes [X] No
Review CDC Requirement
Vaccines should be rotated weekly and when a new shipment comes in so that longer-dated vaccines are stored behind shorter-dated vaccines If vaccines expire they can no longer be stored in the same storage unit with viable vaccines They must be placedin a container or bag clearly labeled ldquoDo not userdquo and separated from viable vaccines to prevent inadvertent use Expired vaccinemust be returned to the centralized distributor within six months of expiration
Goal of this question Ensure there is no expired vaccine in any storage unit
Helpful information bull Sites can prevent their stock from expiring by rotating vaccines every week andor when a new shipment arrives Longer-dated vaccines are stored towards the back of the unit and shorter-dated vaccines are up front
bull Pay attention to vaccines that expire within the next three months Consider transferring vaccine that will expire soon to another MnVFC-enrolled site that will use the vaccine preferably a site close by It is the transferring sitersquos responsibility to arrange the transfer of the vaccine Be sure to complete the MDH Vaccine Transfer Record form and send it to MDH If they are having difficulty finding a location to accept vaccine contact MDH
bull This is a great opportunity to educate sites about the MDH Nonviable Vaccine Form and the process for returning vaccine The VFC program does get some credit for taxes and fees on vaccine that is returned to the distribution center
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MDH Nonviable Vaccine Form and MDH Vaccine Transfer Record on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfcformshtml)
IPI Advisor Manual | February 2017 Page 45
The 2017 MnVFC Site Visit Paperwork Chapter 4
- -
-
Question 555 Storage amp Handling Site Wide Back up Thermometer
Question 55 Does the provider have a readily available back-up thermometer with a current and valid certificate ofcalibration testing
Note to Reviewer ldquoReadily availablerdquo means that the thermometer is available to perform twice-a-day monitoring for a unit asrequired CDC recommends that the back-up thermometer be maintained on site
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have a readily available back-up thermometer with a current and valid certificate of calibration testing Toprevent the certificates of calibration testing of the primary and back-up thermometers from expiring at the same time the date of calibration testing (or issue date) of the back-up thermometer should be different from the date of calibration testing (or issue date) of the primary thermometer As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meetsVFC program requirements
Goal of this question Ensure sites have one calibrated back-up thermometer onsite that is readily available in the event that the temperature monitoring device in unit fails transportation of vaccine is needed or there are other unexpected circumstances
Helpful information bull As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meets VFC Program requirements
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 56 5 Storage amp Handling Site Wide Preparation of Vaccine
Question 56 When does this provider prepare vaccine for administration to the patient
Note to Reviewer For mass vaccination clinics if one type of vaccine is offered providers may pre-draw up to 10 doses Ifusing pre-filled syringes pre-drawing also means activating the syringe by removing the needle guard orattaching a needle
Answers (Choose all that
apply)
Prepare dose immediately before administration Pre-draw doses for upcoming patients (in a regular clinicpractice) [O] Pre-draw up to 10 doses (in a mass-vaccination clinic) Pre-draw more than 10 doses (in a mass-vaccination clinic) [O] Other [O]
Review CDC Recommendation
CDC recommends preparing vaccines immediately prior to administration in order to assure viability of vaccine and prevent vaccinewastage Vaccines that are not administered immediately are at risk of exposure to temperatures outside of the required rangewhich can affect vaccine viability and ultimately can leave children unprotected against vaccine-preventable diseases
Goal of this question Discuss proper timing and preparation of vaccine(s) for administration These are recommendations not requirements
Helpful information bull Educate staff on the importance of preparing vaccine immediately before administration Pre-drawing of vaccines may lead to concerns related to vaccine viability potency sterility and wastage
Page 46 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 6 Inventory Question 61
6 Inventory Inventory Comparison
Question 61 Visually inspect storage units to determine if existing supply of vaccines proportionately mirrorspopulations served Choose the most accurate statement below
Note to Reviewer bull CDC recommends that providers maintain a four-week supply of inventory bull For this question do not take into account vaccine types that the provider does not order Here simply
make sure that overall the vaccines in the providerrsquos storage units are available in sufficient amounts toserve their patient population
Answers (Choose one)
The current vaccine inventory proportionately reflects the populations identified Only public stock is insufficient [X] Only private stock is insufficient [X] Both public and private stock are insufficient [X] Site uses the replacement method but does not appear to have enough vaccine for their population [X] Other [X]
Review CDC Requirement
VFC providers must order and stock routine vaccines in accordance with their patient population in order to prevent missedvaccination opportunities Having sufficient amounts of all stocks prevents the inadvertent use of VFC vaccines for non-VFC-eligiblepatients and vice versa
Goal of this question Assess whether the site is ordering appropriate quantities of vaccine for the population they serve at their site
Helpful information bull If the site sees 30 percent private-pay patients and 70 percent VFC the stock in their storage units should reflect that proportion If you donrsquot know you can ask the site about their population
bull This is meant to be a general assessment so in a big site if they have only a small amount of vaccine that may indicate an issue with vaccine management
bull CDC recommends smaller more frequent orders (ie monthly) rather than large orders to minimize the amount of vaccine loss if an incident occurs during shipment or in the storage unit Sites should not order more frequently than once a month
bull Sites using the replacement method will only have one stock but it should appear to be large enough for their population
bull Only assess the vaccine types that the site currently stocks in their unit We know there are sites that do not offer all ACIP-recommended vaccines for various reasons That issue will be addressed in question 62
IPI Advisor Manual | February 2017 Page 47
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 626 Inventory ACIP Recommended Vaccines
Question 62 Review providerrsquos current inventory to answer the questions below
A Does the provider offer all routine ACIP-recommendedvaccines for their patient population
Yes (Skip to question C) No [X] Offers all except varicella because direct ship ofvaccine is unavailable from manufacturer
B Which routine vaccines are NOT being offered DTaP Hepatitis A Hepatitis B HIB HPV Influenza Meningococcal
MMR Pneumococcal Polio Rotavirus TdapTd Varicella
C According to Immunization Program Policy does theprovider make accessible all non-routine ACIP-recommended vaccines for those VFC patients whomeet the criteria for receiving them
Yes (Skip to question 63) No [X]
D Which non-routine vaccines are NOT being offered Pneumococcal polysaccharide vaccine (PPSV23) Meningococcal Group B (MenB) Other
Review CDC Requirement
VFC providers agree to comply with immunization schedules dosages and contraindications that are established by the Advisory Committee on Immunization Practices (ACIP) for the vaccines identified and agreed upon in the Provider Agreement UNLESS bull In the VFC providers medical judgment and in accordance with accepted medical practice the VFC provider deems such
compliance to be medically inappropriate for the child bull The particular requirements contradict state law including laws pertaining to religious and other exemptions The VFC program entitles children to the following vaccines DTaP Hepatitis A Hepatitis B HIB HPV Influenza MeningococcalMMR Pneumococcal Polio Rotavirus TdapTd and Varicella VFC providers are also required to ensure that VFC-eligible children have access to non-routine vaccines as needed
Goal of this question Assess if the site is offering all the ACIP-recommended vaccines for the population they serve and these vaccines are in stock on the day of the visit It is important that every MnVFC-eligible child that comes to a providerrsquos office for an immunization is vaccinated
Helpful information bull The Advisory Committee on Immunization Practices (ACIP) is a group of medical and public health experts that develops recommendations on how to use vaccines to control diseases in the United States
bull Specialty providers are not required to offer all routine vaccines but should provide the vaccines appropriate for their population
bull If the site does not offer all routine ACIP-recommended vaccines appropriate for their population check the ldquoNordquo box in Part A then check the appropriate box(es) in Part B for any vaccines not offered Please contact MDH as this situation offers us the opportunity to provide education to the site
bull For non-routine vaccines they must either be in stock or the site must have an alternative protocol in the routine management plan that ensures these children have access when applicable
Resources bull IAC Diseases and Vaccines (wwwimmunizeorgvaccines) bull CDC Advisory Committee on Immunization Practices (ACIP) (wwwcdcgovvaccinesacipindexhtml)
Page 48 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 636 Inventory Separation of Stock
Question 63 Observe how the provider differentiates stock in each storage unit to answer the questions below
A Is it clear which vaccines belong to public stock andwhich belong to private stock
Yes No [X] Not applicable replacement site
B Is it clear which vaccines belong to VFC stock andwhich belong to UUAV stock
Yes No [X] Not applicable replacement site Not applicable not UUAV-enrolled site
Review CDC Requirement
In order to ensure that VFC vaccines are only administered to VFC-eligible children VFC providers that serve both VFC and non-VFCshyeligible children must maintain their vaccine inventories in such a way that they can clearly differentiate public stock from privatestock as well as VFC from other public stock
Goal of this question Assess whether the site can distinguish between MnVFC vaccine and private vaccine If they participate in the Uninsured and Underinsured Adult Vaccine (UUAV) program they should also be able to distinguish between MnVFC stock and UUAV stock Some sites use labels bins boxes etc to differentiate their stock If it is not clear how the site differentiates their stock discuss vaccine management with the staff For follow-up call MDH to discuss doing a follow-up site visit
Sites using the replacement method will not have separate stocksmdashthis is an approved alternative method for keeping track of vaccine
Resource bull Section 10 of the MnVFC Policy and Procedure Manual
IPI Advisor Manual | February 2017 Page 49
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
MnVFC Site Visit Storage and Handling Per Unit Answer Sheet 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet MnVFC PIN ___________________
Question number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
Temperature Monitoring Device Questions Questions 43 47 must be answered separately for the freezer and refrigerator if the unit is a combo Be sure to document responses in the appropriate column
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
All the questions on the Site Visit Storage amp Handling Per Unit Answer Sheet have been discussed previously in section 4 of this manual Use this sheet to record information about all the units at the site visit You will need one sheet for each unit If it is a combination unit (either pharmaceutical or household) you can record both sections on one sheet If they have stand-alone units use one sheet for each unit Do not enter the answers to the questions in section 4 of the questionnaire
If you need more information about any of the questions refer back to the main questionnairemdashthe complete question additional guidance including notes to the reviewer and the CDC requirements are there Also if the site is not meeting the requirement you will go back to the questionnaire to complete the ldquoActions if Non-compliantrdquo section including the root cause analysis and follow-up sections
When you have completed the assessment of all the storage units remember to go back to the questionnaire to complete sections 5 and 6
Page 50 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
ndash
ndash
MnVFC Provider Follow-up PlanThe goal of the Provider Follow-up Plan is to communicate with the site all of the VFC requirements any unmet requirements found during your site visit and the timeline for completing the required action The left hand column is a box to check for ldquoUnmetrdquo requirements
Helpful information bull The form can be used to review what the site is doing well and what they need to work on
bull For requirements that have specific documentation that needs to be sent to you use the notes section
2017 MnVFC Provider Follow-up Plan Site _______________________________________________ MnVFC PIN ____________ Date of Visit ___________
Thank you for participating in this MnVFC compliance site visit Please review this visit summary including follow-up actions and timelines for completion Unmet MnVFC requirements and recommendations have a checked box next to them The goal of this plan is to support you with successfully implementing the program and improving access to vaccines for VFC-eligible children
Unmet Question VFC Requirements Section 1 Changes to Key Staff
Q12 Change in the Medical Director Immunization Manager Vaccine Coordinator or back-upKey Staff must be communicated to the immunization program by emailing healthmnvfcstatemnus Changes Notes
Q12 Key staff must complete the annual training on VFC program requirements and print theAnnual Training certificate of completion Documentation Required Action
Staff that have not completed the MnVFC online training must complete it and send acopy of the certificate to the reviewer Training can be found on the MnVFC website (wwwhealthstatemnusvfc) Due date 1 month
Notes
Unmet Question VFC Requirements Section 2 Eligibility
Q21 Provider staff must possess a working knowledge of all VFC eligibility criteria and use thoseVFC Eligibility criteria to screen children prior to administering VFC vaccines
Categories Notes
bull This form provides documentation needed for follow-up actions when you send your thank you email
The second to last page of the Provider Follow-up Plan has a summary of the MnVFC program recommendations These are to remind the site about best practices they may want to improve upon even though they are not yet requirements of the program For example you could discuss the recommendation about storage units if they currently have a combination household unit and are using both sections
The last section is for your signature and the person you met with In most sites it will be the immunization manager or vaccine coordinator who signs the form unless the medical director attended the site visit You keep the original copy and the site will need to keep a copy for themselves
To be completed by the site visit reviewer
I acknowledge that a VFC site visit was performed on __________________ (visit date) The follow-up plan which includes a list of all current VFC program requirements and recommendations assessed during the visit and any required follow-up actions was provided at the end of the visit
Site visit reviewer
Phone
Reviewer Signature Date
To be completed by the provider
I acknowledge that our practice took part in the VFC site visit noted above I understand the findings of the visit and any required actions that must be taken by our office in order to meet VFC program requirements
Medical Director (or designee) Name Title
Medical Director (or designee) Signature Date
IPI Advisor Manual | February 2017 Page 51
The 2017 MnVFC Site Visit Paperwork Chapter 4
After the Site Visit Send a thank you email highlighting the unmet requirements documents you need from the site to resolve the issue(s) and the date you need them Make sure to include the link to the Site Visit Survey (httpssurveyvovicicomseashxs=56206EE334CE0B14)
Please refer to Chapter 3 for more information about future follow-up required after the visit including forms and documentation
Resource bull Sample Thank You letter on IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml)
Chapter 5
IPI Advisor Resource List MnVFC Program 651-201-5522
MnVFC wwwhealthstatemnusvfc
bull Separate Stock and Replacement Method Policies and Procedures Manuals bull Online trainings bull MnVFC Announcements sign up to receive them via email bull Ordering MDH vaccine bull MnVFC forms Screening forms Reporting forms Others MDH Nonviable Vaccine Form MDH Vaccine Transfer Record and Vaccine Borrowing Report
bull MnVFC promotional materials bull Immunization Billing Guidance for MnVFC and Immunization Billing Guidance for MnVFC Replacement Sites Immunization Practices Improvement Program (IPI) wwwhealthstatemnusdivsidepcimmunizeipi
bull IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml) bull IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml) IPI Resource Folder Contents (wwwhealthstatemnusdivsidepcimmunizeipiipifolderpdf)
Minnesota Immunization Information Connection (MIIC) wwwhealthstatemnusmiic
bull MIIC regions and regional coordinators
Clinical Practice MDH Immunization Program wwwhealthstatemnusimmunize
Got Your Shots News wwwhealthstatemnusdivsidepcnewslettersgys
MDH Immunization Information for Health Care Providers wwwhealthstatemnusdivsidepcimmunizehcp
bull Got Your Shots A Providers Guide to Immunization in Minnesota bull Vaccine protocols bull Forms for tracking patient immunizations bull Immunization schedules for Health Care Providers Immunization Action Coalition (IAC) wwwimmunizeorg
bull Ask the Experts bull VISs (Vaccine Information Statements and translations) bull Administration screening questions bull Medical management of vaccine reactions bull Order form for Californiarsquos Immunization Technique DVD Best Practices with Infants Children and Adults
Page 52 IPI Advisor Manual| February 2017
IPI Advisor Resource List Chapter 5
CDC ldquoPink Bookrdquo wwwcdcgovvaccinespubspinkbookindexhtml
CDC Advisory Committee on Immunization Practices (ACIP) wwwcdcgovvaccinesacip
CDC Vaccines and Immunizations wwwcdcgovvaccines
VAERS reporting httpvaershhsgovindex
Storage and Handling Got Your Shots Providers Guide ndash Managing Vaccine wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml
MnVFC Guide to Temperature Monitoring Devices wwwhealthstatemnusvfc
MDH Clinicianrsquos Vaccine Mishap Checklist wwwhealthstatemnusdivsidepcimmunizeipivaxchklstpdf
MDH Vaccine Storage Guide wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml
CDC Vaccine Storage and Handling Toolkit wwwcdcgovvaccinesrecsstoragetoolkit
You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Vaccine manufacturer phone numbers wwwcdcgovvaccinespubspinkbookdownloadsappendicesFcontact-info-manufactpdf
IAC Checklist for Safe Vaccine Handling and Storage wwwimmunizeorgcatgdp3035pdf
IAC Donrsquot Be Guilty of These Errors in Vaccine Storage and Handling wwwimmunizeorgcatgdp3036pdf
Additional Resources Print materials from MDH ndash order forms wwwhealthstatemnusdivsidepcimmunizeordermathtml
Vaccine Education Center ndash Childrenrsquos Hospital of Philadelphia wwwchopeduservicevaccine-education-centerhomehtml
California Department of Public Health ndash Interactive training on vaccine administration and storage and handling handout on transporting vaccine and how to package wwwezizorg
IPI Advisor Manual | February 2017 Page 53
IPI Advisor Resource List Chapter 5
CDC vaccine price list wwwcdcgovvaccinesprogramsvfcawardeesvaccine-managementprice-listindexhtml
Vaccine Information Statements (VIS) wwwcdcgovvaccineshcpvisindexhtml
CEU Opportunities CDC Immunization Education and Training wwwcdcgovvaccinesedindexhtml
Immunization You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Page 54 IPI Advisor Manual| February 2017
- Introduction
-
- Welcome to the Immunization Practice Improvement (IPI) Program
- Contact Information
-
- Chapter 1
- Requirements to Participate in the MnVFC Program
- Vaccines for Children Program
- Chapter 2
- Reimbursement for MnVFC Visits
- Types of Visits
- Your MnVFC Clinical CoordinatorPlanner
- New IPI Advisor Training Requirements
- Your Role as an IPI Advisor
- Reasons MDH Would Do All or Part of a Visit
- Chapter 3
- Future follow-up
- Conducting the Visit
- Preparing for the Visit
- Information for the Visit
- Site Visit Checklist
- Scheduling the Visit
- Chapter 4
- After the Site Visit
- MnVFC Provider Follow-up Plan
- MnVFC Site Visit Storage and Handling Per Unit Answer Sheet
- Section 6 Inventory
- Section 5 Storage amp Handling Site-Wide
- Section 4 Storage amp Handling Per Unit
- Section 3 Documentation
- Section 2 Eligibility
- Section 1 Provider Details
- The Site Visit Reviewer Legend
- MnVFC Site Visit Questionnaire
- Required Paperwork for Site Visits
- Chapter 5
-
Page 42 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
- -
Section 5 Storage amp Handling Site-Wide Question 51
5 Storage amp Handling Site Wide Discussion of Cost amp Quantity of Vaccine
Question 51 Have a discussion with the provider about the cost and quantity of VFC vaccines they are responsible for annually Address the points listed in the note to reviewer below
Note to Reviewer bull Vaccine Shipped (Required) Share the cost of VFC vaccines shipped to the provider in the last calendaryear to make sure the provider understands the contribution made by the VFC Program to their practiceFor new providers who do not have ldquocalendar yearrdquo data share either the actual cost of their currentinventory or use the cost of 10 VFC doses of each of the ACIP-recommended vaccines (approximately $7000) to help estimate their annual cost
bull Storage amp Handling (Required) Make sure the provider understands the cost of vaccines for which they are responsible when they make decisions about purchasing recommended vaccine storage and temperature monitoring equipment
Answer I have discussed with the provider the cost and quantity of vaccines ordered in the previous calendar year
Goal of this question Inform sites of the quantity and value of vaccines that they receive as part of the MnVFC program Providers often donrsquot realize the value of the vaccine in their unit This information is included on your clinic list and on the one page site-specific information
Helpful information bull This discussion must occur and the box on the questionnaire must be checked bull If there isnrsquot actual vaccine value information available tell the site that one vaccine order that includes a box of each of the ACIP recommended vaccines costs approximately $7000
bull MDH may not have specific information for individual sites if they receive vaccine from a central warehouse or pharmacy For those sites MDH will give you numbers for the whole system so you can discuss system wide data as appropriate If individual site information is also included it is usually just varicella-containing vaccines that must be shipped directly to the site
Question 52
5 Storage amp Handling Site Wide Dorm Style Units
Question 52 Determine whether the provider has any dorm-style units on site and answer the questions below
Note to Reviewer A dormitory-style refrigerator is a unit that has both refrigerator and freezer compartments behind a singleexterior door Dorm-style units also have an evaporator plate (cooling coil) which is usually located insidean icemaker compartment (freezer) within the refrigerator
A Does the provider have any dorm-style units that are used at any time tostore vaccines
Yes [X] No (Skip to question 53)
B Does the provider have sufficient space in existing compliant vaccinestorage units to store all vaccines without use of the dorm-style unit at any time
Yes No [X]
Review CDC Requirement
Dorm- and bar-style units are prohibited for vaccine storage Vaccines stored in dorm-style units are considered non-viable and must be returned to the centralized distributor CDC recommends the following vaccine storage unit types (in order of preference)pharmaceutical grade stand-alone or combination units (preferred) householdcommercial stand-alone unitshouseholdcommercial combination units using the refrigerator section only
Goal of this question Ensure no vaccine is stored in dorm-style units even for short periods of time Encourage them to label any units ldquoNo Vaccine Storage Allowedrdquo Vaccine stored in these units is considered non-viable If a site is using a dorm-style unit call the MnVFC program (651-201-5522)
Resource Section 8 in the MnVFC Policies and Procedures Manual
IPI Advisor Manual | February 2017 Page 43
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 535 Storage amp Handling Site Wide Storage Unit Space Availability
Question 53 Does the provider have sufficient room across storage units to store current stock as well as anyadditional stock acquired during peak season without overcrowding
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have sufficient storage space to accommodate vaccine stock at the busiest time of year without overcrowding
Goal of this question Ensure that sites have sufficient space in their units to maintain vaccines at the busiest time of year Overcrowding of vaccine limits air circulation and affects the unitrsquos ability to maintain stable temperatures
Helpful information bull Look for signs of overcrowding such as vaccines that are pushed up against the wall bins that are overflowing or storage units that are full during non-peak seasons
Discuss immediate actions if the unit is overcrowded Move some of their vaccines order less vaccine more frequently (once per month preferably) andor purchase another storage unit for overflow
Resource bull Section 8 MnVFC Policy and Procedure Manual
Page 44 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 545 Storage amp Handling Site Wide Expired Vaccines
Question 54 Look in each unit Are there expired vaccines in any of the vaccine storage units at this site
Answers (Choose one)
Yes [X] No
Review CDC Requirement
Vaccines should be rotated weekly and when a new shipment comes in so that longer-dated vaccines are stored behind shorter-dated vaccines If vaccines expire they can no longer be stored in the same storage unit with viable vaccines They must be placedin a container or bag clearly labeled ldquoDo not userdquo and separated from viable vaccines to prevent inadvertent use Expired vaccinemust be returned to the centralized distributor within six months of expiration
Goal of this question Ensure there is no expired vaccine in any storage unit
Helpful information bull Sites can prevent their stock from expiring by rotating vaccines every week andor when a new shipment arrives Longer-dated vaccines are stored towards the back of the unit and shorter-dated vaccines are up front
bull Pay attention to vaccines that expire within the next three months Consider transferring vaccine that will expire soon to another MnVFC-enrolled site that will use the vaccine preferably a site close by It is the transferring sitersquos responsibility to arrange the transfer of the vaccine Be sure to complete the MDH Vaccine Transfer Record form and send it to MDH If they are having difficulty finding a location to accept vaccine contact MDH
bull This is a great opportunity to educate sites about the MDH Nonviable Vaccine Form and the process for returning vaccine The VFC program does get some credit for taxes and fees on vaccine that is returned to the distribution center
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MDH Nonviable Vaccine Form and MDH Vaccine Transfer Record on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfcformshtml)
IPI Advisor Manual | February 2017 Page 45
The 2017 MnVFC Site Visit Paperwork Chapter 4
- -
-
Question 555 Storage amp Handling Site Wide Back up Thermometer
Question 55 Does the provider have a readily available back-up thermometer with a current and valid certificate ofcalibration testing
Note to Reviewer ldquoReadily availablerdquo means that the thermometer is available to perform twice-a-day monitoring for a unit asrequired CDC recommends that the back-up thermometer be maintained on site
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have a readily available back-up thermometer with a current and valid certificate of calibration testing Toprevent the certificates of calibration testing of the primary and back-up thermometers from expiring at the same time the date of calibration testing (or issue date) of the back-up thermometer should be different from the date of calibration testing (or issue date) of the primary thermometer As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meetsVFC program requirements
Goal of this question Ensure sites have one calibrated back-up thermometer onsite that is readily available in the event that the temperature monitoring device in unit fails transportation of vaccine is needed or there are other unexpected circumstances
Helpful information bull As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meets VFC Program requirements
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 56 5 Storage amp Handling Site Wide Preparation of Vaccine
Question 56 When does this provider prepare vaccine for administration to the patient
Note to Reviewer For mass vaccination clinics if one type of vaccine is offered providers may pre-draw up to 10 doses Ifusing pre-filled syringes pre-drawing also means activating the syringe by removing the needle guard orattaching a needle
Answers (Choose all that
apply)
Prepare dose immediately before administration Pre-draw doses for upcoming patients (in a regular clinicpractice) [O] Pre-draw up to 10 doses (in a mass-vaccination clinic) Pre-draw more than 10 doses (in a mass-vaccination clinic) [O] Other [O]
Review CDC Recommendation
CDC recommends preparing vaccines immediately prior to administration in order to assure viability of vaccine and prevent vaccinewastage Vaccines that are not administered immediately are at risk of exposure to temperatures outside of the required rangewhich can affect vaccine viability and ultimately can leave children unprotected against vaccine-preventable diseases
Goal of this question Discuss proper timing and preparation of vaccine(s) for administration These are recommendations not requirements
Helpful information bull Educate staff on the importance of preparing vaccine immediately before administration Pre-drawing of vaccines may lead to concerns related to vaccine viability potency sterility and wastage
Page 46 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 6 Inventory Question 61
6 Inventory Inventory Comparison
Question 61 Visually inspect storage units to determine if existing supply of vaccines proportionately mirrorspopulations served Choose the most accurate statement below
Note to Reviewer bull CDC recommends that providers maintain a four-week supply of inventory bull For this question do not take into account vaccine types that the provider does not order Here simply
make sure that overall the vaccines in the providerrsquos storage units are available in sufficient amounts toserve their patient population
Answers (Choose one)
The current vaccine inventory proportionately reflects the populations identified Only public stock is insufficient [X] Only private stock is insufficient [X] Both public and private stock are insufficient [X] Site uses the replacement method but does not appear to have enough vaccine for their population [X] Other [X]
Review CDC Requirement
VFC providers must order and stock routine vaccines in accordance with their patient population in order to prevent missedvaccination opportunities Having sufficient amounts of all stocks prevents the inadvertent use of VFC vaccines for non-VFC-eligiblepatients and vice versa
Goal of this question Assess whether the site is ordering appropriate quantities of vaccine for the population they serve at their site
Helpful information bull If the site sees 30 percent private-pay patients and 70 percent VFC the stock in their storage units should reflect that proportion If you donrsquot know you can ask the site about their population
bull This is meant to be a general assessment so in a big site if they have only a small amount of vaccine that may indicate an issue with vaccine management
bull CDC recommends smaller more frequent orders (ie monthly) rather than large orders to minimize the amount of vaccine loss if an incident occurs during shipment or in the storage unit Sites should not order more frequently than once a month
bull Sites using the replacement method will only have one stock but it should appear to be large enough for their population
bull Only assess the vaccine types that the site currently stocks in their unit We know there are sites that do not offer all ACIP-recommended vaccines for various reasons That issue will be addressed in question 62
IPI Advisor Manual | February 2017 Page 47
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 626 Inventory ACIP Recommended Vaccines
Question 62 Review providerrsquos current inventory to answer the questions below
A Does the provider offer all routine ACIP-recommendedvaccines for their patient population
Yes (Skip to question C) No [X] Offers all except varicella because direct ship ofvaccine is unavailable from manufacturer
B Which routine vaccines are NOT being offered DTaP Hepatitis A Hepatitis B HIB HPV Influenza Meningococcal
MMR Pneumococcal Polio Rotavirus TdapTd Varicella
C According to Immunization Program Policy does theprovider make accessible all non-routine ACIP-recommended vaccines for those VFC patients whomeet the criteria for receiving them
Yes (Skip to question 63) No [X]
D Which non-routine vaccines are NOT being offered Pneumococcal polysaccharide vaccine (PPSV23) Meningococcal Group B (MenB) Other
Review CDC Requirement
VFC providers agree to comply with immunization schedules dosages and contraindications that are established by the Advisory Committee on Immunization Practices (ACIP) for the vaccines identified and agreed upon in the Provider Agreement UNLESS bull In the VFC providers medical judgment and in accordance with accepted medical practice the VFC provider deems such
compliance to be medically inappropriate for the child bull The particular requirements contradict state law including laws pertaining to religious and other exemptions The VFC program entitles children to the following vaccines DTaP Hepatitis A Hepatitis B HIB HPV Influenza MeningococcalMMR Pneumococcal Polio Rotavirus TdapTd and Varicella VFC providers are also required to ensure that VFC-eligible children have access to non-routine vaccines as needed
Goal of this question Assess if the site is offering all the ACIP-recommended vaccines for the population they serve and these vaccines are in stock on the day of the visit It is important that every MnVFC-eligible child that comes to a providerrsquos office for an immunization is vaccinated
Helpful information bull The Advisory Committee on Immunization Practices (ACIP) is a group of medical and public health experts that develops recommendations on how to use vaccines to control diseases in the United States
bull Specialty providers are not required to offer all routine vaccines but should provide the vaccines appropriate for their population
bull If the site does not offer all routine ACIP-recommended vaccines appropriate for their population check the ldquoNordquo box in Part A then check the appropriate box(es) in Part B for any vaccines not offered Please contact MDH as this situation offers us the opportunity to provide education to the site
bull For non-routine vaccines they must either be in stock or the site must have an alternative protocol in the routine management plan that ensures these children have access when applicable
Resources bull IAC Diseases and Vaccines (wwwimmunizeorgvaccines) bull CDC Advisory Committee on Immunization Practices (ACIP) (wwwcdcgovvaccinesacipindexhtml)
Page 48 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 636 Inventory Separation of Stock
Question 63 Observe how the provider differentiates stock in each storage unit to answer the questions below
A Is it clear which vaccines belong to public stock andwhich belong to private stock
Yes No [X] Not applicable replacement site
B Is it clear which vaccines belong to VFC stock andwhich belong to UUAV stock
Yes No [X] Not applicable replacement site Not applicable not UUAV-enrolled site
Review CDC Requirement
In order to ensure that VFC vaccines are only administered to VFC-eligible children VFC providers that serve both VFC and non-VFCshyeligible children must maintain their vaccine inventories in such a way that they can clearly differentiate public stock from privatestock as well as VFC from other public stock
Goal of this question Assess whether the site can distinguish between MnVFC vaccine and private vaccine If they participate in the Uninsured and Underinsured Adult Vaccine (UUAV) program they should also be able to distinguish between MnVFC stock and UUAV stock Some sites use labels bins boxes etc to differentiate their stock If it is not clear how the site differentiates their stock discuss vaccine management with the staff For follow-up call MDH to discuss doing a follow-up site visit
Sites using the replacement method will not have separate stocksmdashthis is an approved alternative method for keeping track of vaccine
Resource bull Section 10 of the MnVFC Policy and Procedure Manual
IPI Advisor Manual | February 2017 Page 49
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
MnVFC Site Visit Storage and Handling Per Unit Answer Sheet 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet MnVFC PIN ___________________
Question number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
Temperature Monitoring Device Questions Questions 43 47 must be answered separately for the freezer and refrigerator if the unit is a combo Be sure to document responses in the appropriate column
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
All the questions on the Site Visit Storage amp Handling Per Unit Answer Sheet have been discussed previously in section 4 of this manual Use this sheet to record information about all the units at the site visit You will need one sheet for each unit If it is a combination unit (either pharmaceutical or household) you can record both sections on one sheet If they have stand-alone units use one sheet for each unit Do not enter the answers to the questions in section 4 of the questionnaire
If you need more information about any of the questions refer back to the main questionnairemdashthe complete question additional guidance including notes to the reviewer and the CDC requirements are there Also if the site is not meeting the requirement you will go back to the questionnaire to complete the ldquoActions if Non-compliantrdquo section including the root cause analysis and follow-up sections
When you have completed the assessment of all the storage units remember to go back to the questionnaire to complete sections 5 and 6
Page 50 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
ndash
ndash
MnVFC Provider Follow-up PlanThe goal of the Provider Follow-up Plan is to communicate with the site all of the VFC requirements any unmet requirements found during your site visit and the timeline for completing the required action The left hand column is a box to check for ldquoUnmetrdquo requirements
Helpful information bull The form can be used to review what the site is doing well and what they need to work on
bull For requirements that have specific documentation that needs to be sent to you use the notes section
2017 MnVFC Provider Follow-up Plan Site _______________________________________________ MnVFC PIN ____________ Date of Visit ___________
Thank you for participating in this MnVFC compliance site visit Please review this visit summary including follow-up actions and timelines for completion Unmet MnVFC requirements and recommendations have a checked box next to them The goal of this plan is to support you with successfully implementing the program and improving access to vaccines for VFC-eligible children
Unmet Question VFC Requirements Section 1 Changes to Key Staff
Q12 Change in the Medical Director Immunization Manager Vaccine Coordinator or back-upKey Staff must be communicated to the immunization program by emailing healthmnvfcstatemnus Changes Notes
Q12 Key staff must complete the annual training on VFC program requirements and print theAnnual Training certificate of completion Documentation Required Action
Staff that have not completed the MnVFC online training must complete it and send acopy of the certificate to the reviewer Training can be found on the MnVFC website (wwwhealthstatemnusvfc) Due date 1 month
Notes
Unmet Question VFC Requirements Section 2 Eligibility
Q21 Provider staff must possess a working knowledge of all VFC eligibility criteria and use thoseVFC Eligibility criteria to screen children prior to administering VFC vaccines
Categories Notes
bull This form provides documentation needed for follow-up actions when you send your thank you email
The second to last page of the Provider Follow-up Plan has a summary of the MnVFC program recommendations These are to remind the site about best practices they may want to improve upon even though they are not yet requirements of the program For example you could discuss the recommendation about storage units if they currently have a combination household unit and are using both sections
The last section is for your signature and the person you met with In most sites it will be the immunization manager or vaccine coordinator who signs the form unless the medical director attended the site visit You keep the original copy and the site will need to keep a copy for themselves
To be completed by the site visit reviewer
I acknowledge that a VFC site visit was performed on __________________ (visit date) The follow-up plan which includes a list of all current VFC program requirements and recommendations assessed during the visit and any required follow-up actions was provided at the end of the visit
Site visit reviewer
Phone
Reviewer Signature Date
To be completed by the provider
I acknowledge that our practice took part in the VFC site visit noted above I understand the findings of the visit and any required actions that must be taken by our office in order to meet VFC program requirements
Medical Director (or designee) Name Title
Medical Director (or designee) Signature Date
IPI Advisor Manual | February 2017 Page 51
The 2017 MnVFC Site Visit Paperwork Chapter 4
After the Site Visit Send a thank you email highlighting the unmet requirements documents you need from the site to resolve the issue(s) and the date you need them Make sure to include the link to the Site Visit Survey (httpssurveyvovicicomseashxs=56206EE334CE0B14)
Please refer to Chapter 3 for more information about future follow-up required after the visit including forms and documentation
Resource bull Sample Thank You letter on IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml)
Chapter 5
IPI Advisor Resource List MnVFC Program 651-201-5522
MnVFC wwwhealthstatemnusvfc
bull Separate Stock and Replacement Method Policies and Procedures Manuals bull Online trainings bull MnVFC Announcements sign up to receive them via email bull Ordering MDH vaccine bull MnVFC forms Screening forms Reporting forms Others MDH Nonviable Vaccine Form MDH Vaccine Transfer Record and Vaccine Borrowing Report
bull MnVFC promotional materials bull Immunization Billing Guidance for MnVFC and Immunization Billing Guidance for MnVFC Replacement Sites Immunization Practices Improvement Program (IPI) wwwhealthstatemnusdivsidepcimmunizeipi
bull IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml) bull IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml) IPI Resource Folder Contents (wwwhealthstatemnusdivsidepcimmunizeipiipifolderpdf)
Minnesota Immunization Information Connection (MIIC) wwwhealthstatemnusmiic
bull MIIC regions and regional coordinators
Clinical Practice MDH Immunization Program wwwhealthstatemnusimmunize
Got Your Shots News wwwhealthstatemnusdivsidepcnewslettersgys
MDH Immunization Information for Health Care Providers wwwhealthstatemnusdivsidepcimmunizehcp
bull Got Your Shots A Providers Guide to Immunization in Minnesota bull Vaccine protocols bull Forms for tracking patient immunizations bull Immunization schedules for Health Care Providers Immunization Action Coalition (IAC) wwwimmunizeorg
bull Ask the Experts bull VISs (Vaccine Information Statements and translations) bull Administration screening questions bull Medical management of vaccine reactions bull Order form for Californiarsquos Immunization Technique DVD Best Practices with Infants Children and Adults
Page 52 IPI Advisor Manual| February 2017
IPI Advisor Resource List Chapter 5
CDC ldquoPink Bookrdquo wwwcdcgovvaccinespubspinkbookindexhtml
CDC Advisory Committee on Immunization Practices (ACIP) wwwcdcgovvaccinesacip
CDC Vaccines and Immunizations wwwcdcgovvaccines
VAERS reporting httpvaershhsgovindex
Storage and Handling Got Your Shots Providers Guide ndash Managing Vaccine wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml
MnVFC Guide to Temperature Monitoring Devices wwwhealthstatemnusvfc
MDH Clinicianrsquos Vaccine Mishap Checklist wwwhealthstatemnusdivsidepcimmunizeipivaxchklstpdf
MDH Vaccine Storage Guide wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml
CDC Vaccine Storage and Handling Toolkit wwwcdcgovvaccinesrecsstoragetoolkit
You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Vaccine manufacturer phone numbers wwwcdcgovvaccinespubspinkbookdownloadsappendicesFcontact-info-manufactpdf
IAC Checklist for Safe Vaccine Handling and Storage wwwimmunizeorgcatgdp3035pdf
IAC Donrsquot Be Guilty of These Errors in Vaccine Storage and Handling wwwimmunizeorgcatgdp3036pdf
Additional Resources Print materials from MDH ndash order forms wwwhealthstatemnusdivsidepcimmunizeordermathtml
Vaccine Education Center ndash Childrenrsquos Hospital of Philadelphia wwwchopeduservicevaccine-education-centerhomehtml
California Department of Public Health ndash Interactive training on vaccine administration and storage and handling handout on transporting vaccine and how to package wwwezizorg
IPI Advisor Manual | February 2017 Page 53
IPI Advisor Resource List Chapter 5
CDC vaccine price list wwwcdcgovvaccinesprogramsvfcawardeesvaccine-managementprice-listindexhtml
Vaccine Information Statements (VIS) wwwcdcgovvaccineshcpvisindexhtml
CEU Opportunities CDC Immunization Education and Training wwwcdcgovvaccinesedindexhtml
Immunization You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Page 54 IPI Advisor Manual| February 2017
- Introduction
-
- Welcome to the Immunization Practice Improvement (IPI) Program
- Contact Information
-
- Chapter 1
- Requirements to Participate in the MnVFC Program
- Vaccines for Children Program
- Chapter 2
- Reimbursement for MnVFC Visits
- Types of Visits
- Your MnVFC Clinical CoordinatorPlanner
- New IPI Advisor Training Requirements
- Your Role as an IPI Advisor
- Reasons MDH Would Do All or Part of a Visit
- Chapter 3
- Future follow-up
- Conducting the Visit
- Preparing for the Visit
- Information for the Visit
- Site Visit Checklist
- Scheduling the Visit
- Chapter 4
- After the Site Visit
- MnVFC Provider Follow-up Plan
- MnVFC Site Visit Storage and Handling Per Unit Answer Sheet
- Section 6 Inventory
- Section 5 Storage amp Handling Site-Wide
- Section 4 Storage amp Handling Per Unit
- Section 3 Documentation
- Section 2 Eligibility
- Section 1 Provider Details
- The Site Visit Reviewer Legend
- MnVFC Site Visit Questionnaire
- Required Paperwork for Site Visits
- Chapter 5
-
IPI Advisor Manual | February 2017 Page 43
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 535 Storage amp Handling Site Wide Storage Unit Space Availability
Question 53 Does the provider have sufficient room across storage units to store current stock as well as anyadditional stock acquired during peak season without overcrowding
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have sufficient storage space to accommodate vaccine stock at the busiest time of year without overcrowding
Goal of this question Ensure that sites have sufficient space in their units to maintain vaccines at the busiest time of year Overcrowding of vaccine limits air circulation and affects the unitrsquos ability to maintain stable temperatures
Helpful information bull Look for signs of overcrowding such as vaccines that are pushed up against the wall bins that are overflowing or storage units that are full during non-peak seasons
Discuss immediate actions if the unit is overcrowded Move some of their vaccines order less vaccine more frequently (once per month preferably) andor purchase another storage unit for overflow
Resource bull Section 8 MnVFC Policy and Procedure Manual
Page 44 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 545 Storage amp Handling Site Wide Expired Vaccines
Question 54 Look in each unit Are there expired vaccines in any of the vaccine storage units at this site
Answers (Choose one)
Yes [X] No
Review CDC Requirement
Vaccines should be rotated weekly and when a new shipment comes in so that longer-dated vaccines are stored behind shorter-dated vaccines If vaccines expire they can no longer be stored in the same storage unit with viable vaccines They must be placedin a container or bag clearly labeled ldquoDo not userdquo and separated from viable vaccines to prevent inadvertent use Expired vaccinemust be returned to the centralized distributor within six months of expiration
Goal of this question Ensure there is no expired vaccine in any storage unit
Helpful information bull Sites can prevent their stock from expiring by rotating vaccines every week andor when a new shipment arrives Longer-dated vaccines are stored towards the back of the unit and shorter-dated vaccines are up front
bull Pay attention to vaccines that expire within the next three months Consider transferring vaccine that will expire soon to another MnVFC-enrolled site that will use the vaccine preferably a site close by It is the transferring sitersquos responsibility to arrange the transfer of the vaccine Be sure to complete the MDH Vaccine Transfer Record form and send it to MDH If they are having difficulty finding a location to accept vaccine contact MDH
bull This is a great opportunity to educate sites about the MDH Nonviable Vaccine Form and the process for returning vaccine The VFC program does get some credit for taxes and fees on vaccine that is returned to the distribution center
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MDH Nonviable Vaccine Form and MDH Vaccine Transfer Record on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfcformshtml)
IPI Advisor Manual | February 2017 Page 45
The 2017 MnVFC Site Visit Paperwork Chapter 4
- -
-
Question 555 Storage amp Handling Site Wide Back up Thermometer
Question 55 Does the provider have a readily available back-up thermometer with a current and valid certificate ofcalibration testing
Note to Reviewer ldquoReadily availablerdquo means that the thermometer is available to perform twice-a-day monitoring for a unit asrequired CDC recommends that the back-up thermometer be maintained on site
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have a readily available back-up thermometer with a current and valid certificate of calibration testing Toprevent the certificates of calibration testing of the primary and back-up thermometers from expiring at the same time the date of calibration testing (or issue date) of the back-up thermometer should be different from the date of calibration testing (or issue date) of the primary thermometer As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meetsVFC program requirements
Goal of this question Ensure sites have one calibrated back-up thermometer onsite that is readily available in the event that the temperature monitoring device in unit fails transportation of vaccine is needed or there are other unexpected circumstances
Helpful information bull As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meets VFC Program requirements
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 56 5 Storage amp Handling Site Wide Preparation of Vaccine
Question 56 When does this provider prepare vaccine for administration to the patient
Note to Reviewer For mass vaccination clinics if one type of vaccine is offered providers may pre-draw up to 10 doses Ifusing pre-filled syringes pre-drawing also means activating the syringe by removing the needle guard orattaching a needle
Answers (Choose all that
apply)
Prepare dose immediately before administration Pre-draw doses for upcoming patients (in a regular clinicpractice) [O] Pre-draw up to 10 doses (in a mass-vaccination clinic) Pre-draw more than 10 doses (in a mass-vaccination clinic) [O] Other [O]
Review CDC Recommendation
CDC recommends preparing vaccines immediately prior to administration in order to assure viability of vaccine and prevent vaccinewastage Vaccines that are not administered immediately are at risk of exposure to temperatures outside of the required rangewhich can affect vaccine viability and ultimately can leave children unprotected against vaccine-preventable diseases
Goal of this question Discuss proper timing and preparation of vaccine(s) for administration These are recommendations not requirements
Helpful information bull Educate staff on the importance of preparing vaccine immediately before administration Pre-drawing of vaccines may lead to concerns related to vaccine viability potency sterility and wastage
Page 46 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 6 Inventory Question 61
6 Inventory Inventory Comparison
Question 61 Visually inspect storage units to determine if existing supply of vaccines proportionately mirrorspopulations served Choose the most accurate statement below
Note to Reviewer bull CDC recommends that providers maintain a four-week supply of inventory bull For this question do not take into account vaccine types that the provider does not order Here simply
make sure that overall the vaccines in the providerrsquos storage units are available in sufficient amounts toserve their patient population
Answers (Choose one)
The current vaccine inventory proportionately reflects the populations identified Only public stock is insufficient [X] Only private stock is insufficient [X] Both public and private stock are insufficient [X] Site uses the replacement method but does not appear to have enough vaccine for their population [X] Other [X]
Review CDC Requirement
VFC providers must order and stock routine vaccines in accordance with their patient population in order to prevent missedvaccination opportunities Having sufficient amounts of all stocks prevents the inadvertent use of VFC vaccines for non-VFC-eligiblepatients and vice versa
Goal of this question Assess whether the site is ordering appropriate quantities of vaccine for the population they serve at their site
Helpful information bull If the site sees 30 percent private-pay patients and 70 percent VFC the stock in their storage units should reflect that proportion If you donrsquot know you can ask the site about their population
bull This is meant to be a general assessment so in a big site if they have only a small amount of vaccine that may indicate an issue with vaccine management
bull CDC recommends smaller more frequent orders (ie monthly) rather than large orders to minimize the amount of vaccine loss if an incident occurs during shipment or in the storage unit Sites should not order more frequently than once a month
bull Sites using the replacement method will only have one stock but it should appear to be large enough for their population
bull Only assess the vaccine types that the site currently stocks in their unit We know there are sites that do not offer all ACIP-recommended vaccines for various reasons That issue will be addressed in question 62
IPI Advisor Manual | February 2017 Page 47
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 626 Inventory ACIP Recommended Vaccines
Question 62 Review providerrsquos current inventory to answer the questions below
A Does the provider offer all routine ACIP-recommendedvaccines for their patient population
Yes (Skip to question C) No [X] Offers all except varicella because direct ship ofvaccine is unavailable from manufacturer
B Which routine vaccines are NOT being offered DTaP Hepatitis A Hepatitis B HIB HPV Influenza Meningococcal
MMR Pneumococcal Polio Rotavirus TdapTd Varicella
C According to Immunization Program Policy does theprovider make accessible all non-routine ACIP-recommended vaccines for those VFC patients whomeet the criteria for receiving them
Yes (Skip to question 63) No [X]
D Which non-routine vaccines are NOT being offered Pneumococcal polysaccharide vaccine (PPSV23) Meningococcal Group B (MenB) Other
Review CDC Requirement
VFC providers agree to comply with immunization schedules dosages and contraindications that are established by the Advisory Committee on Immunization Practices (ACIP) for the vaccines identified and agreed upon in the Provider Agreement UNLESS bull In the VFC providers medical judgment and in accordance with accepted medical practice the VFC provider deems such
compliance to be medically inappropriate for the child bull The particular requirements contradict state law including laws pertaining to religious and other exemptions The VFC program entitles children to the following vaccines DTaP Hepatitis A Hepatitis B HIB HPV Influenza MeningococcalMMR Pneumococcal Polio Rotavirus TdapTd and Varicella VFC providers are also required to ensure that VFC-eligible children have access to non-routine vaccines as needed
Goal of this question Assess if the site is offering all the ACIP-recommended vaccines for the population they serve and these vaccines are in stock on the day of the visit It is important that every MnVFC-eligible child that comes to a providerrsquos office for an immunization is vaccinated
Helpful information bull The Advisory Committee on Immunization Practices (ACIP) is a group of medical and public health experts that develops recommendations on how to use vaccines to control diseases in the United States
bull Specialty providers are not required to offer all routine vaccines but should provide the vaccines appropriate for their population
bull If the site does not offer all routine ACIP-recommended vaccines appropriate for their population check the ldquoNordquo box in Part A then check the appropriate box(es) in Part B for any vaccines not offered Please contact MDH as this situation offers us the opportunity to provide education to the site
bull For non-routine vaccines they must either be in stock or the site must have an alternative protocol in the routine management plan that ensures these children have access when applicable
Resources bull IAC Diseases and Vaccines (wwwimmunizeorgvaccines) bull CDC Advisory Committee on Immunization Practices (ACIP) (wwwcdcgovvaccinesacipindexhtml)
Page 48 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 636 Inventory Separation of Stock
Question 63 Observe how the provider differentiates stock in each storage unit to answer the questions below
A Is it clear which vaccines belong to public stock andwhich belong to private stock
Yes No [X] Not applicable replacement site
B Is it clear which vaccines belong to VFC stock andwhich belong to UUAV stock
Yes No [X] Not applicable replacement site Not applicable not UUAV-enrolled site
Review CDC Requirement
In order to ensure that VFC vaccines are only administered to VFC-eligible children VFC providers that serve both VFC and non-VFCshyeligible children must maintain their vaccine inventories in such a way that they can clearly differentiate public stock from privatestock as well as VFC from other public stock
Goal of this question Assess whether the site can distinguish between MnVFC vaccine and private vaccine If they participate in the Uninsured and Underinsured Adult Vaccine (UUAV) program they should also be able to distinguish between MnVFC stock and UUAV stock Some sites use labels bins boxes etc to differentiate their stock If it is not clear how the site differentiates their stock discuss vaccine management with the staff For follow-up call MDH to discuss doing a follow-up site visit
Sites using the replacement method will not have separate stocksmdashthis is an approved alternative method for keeping track of vaccine
Resource bull Section 10 of the MnVFC Policy and Procedure Manual
IPI Advisor Manual | February 2017 Page 49
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
MnVFC Site Visit Storage and Handling Per Unit Answer Sheet 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet MnVFC PIN ___________________
Question number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
Temperature Monitoring Device Questions Questions 43 47 must be answered separately for the freezer and refrigerator if the unit is a combo Be sure to document responses in the appropriate column
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
All the questions on the Site Visit Storage amp Handling Per Unit Answer Sheet have been discussed previously in section 4 of this manual Use this sheet to record information about all the units at the site visit You will need one sheet for each unit If it is a combination unit (either pharmaceutical or household) you can record both sections on one sheet If they have stand-alone units use one sheet for each unit Do not enter the answers to the questions in section 4 of the questionnaire
If you need more information about any of the questions refer back to the main questionnairemdashthe complete question additional guidance including notes to the reviewer and the CDC requirements are there Also if the site is not meeting the requirement you will go back to the questionnaire to complete the ldquoActions if Non-compliantrdquo section including the root cause analysis and follow-up sections
When you have completed the assessment of all the storage units remember to go back to the questionnaire to complete sections 5 and 6
Page 50 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
ndash
ndash
MnVFC Provider Follow-up PlanThe goal of the Provider Follow-up Plan is to communicate with the site all of the VFC requirements any unmet requirements found during your site visit and the timeline for completing the required action The left hand column is a box to check for ldquoUnmetrdquo requirements
Helpful information bull The form can be used to review what the site is doing well and what they need to work on
bull For requirements that have specific documentation that needs to be sent to you use the notes section
2017 MnVFC Provider Follow-up Plan Site _______________________________________________ MnVFC PIN ____________ Date of Visit ___________
Thank you for participating in this MnVFC compliance site visit Please review this visit summary including follow-up actions and timelines for completion Unmet MnVFC requirements and recommendations have a checked box next to them The goal of this plan is to support you with successfully implementing the program and improving access to vaccines for VFC-eligible children
Unmet Question VFC Requirements Section 1 Changes to Key Staff
Q12 Change in the Medical Director Immunization Manager Vaccine Coordinator or back-upKey Staff must be communicated to the immunization program by emailing healthmnvfcstatemnus Changes Notes
Q12 Key staff must complete the annual training on VFC program requirements and print theAnnual Training certificate of completion Documentation Required Action
Staff that have not completed the MnVFC online training must complete it and send acopy of the certificate to the reviewer Training can be found on the MnVFC website (wwwhealthstatemnusvfc) Due date 1 month
Notes
Unmet Question VFC Requirements Section 2 Eligibility
Q21 Provider staff must possess a working knowledge of all VFC eligibility criteria and use thoseVFC Eligibility criteria to screen children prior to administering VFC vaccines
Categories Notes
bull This form provides documentation needed for follow-up actions when you send your thank you email
The second to last page of the Provider Follow-up Plan has a summary of the MnVFC program recommendations These are to remind the site about best practices they may want to improve upon even though they are not yet requirements of the program For example you could discuss the recommendation about storage units if they currently have a combination household unit and are using both sections
The last section is for your signature and the person you met with In most sites it will be the immunization manager or vaccine coordinator who signs the form unless the medical director attended the site visit You keep the original copy and the site will need to keep a copy for themselves
To be completed by the site visit reviewer
I acknowledge that a VFC site visit was performed on __________________ (visit date) The follow-up plan which includes a list of all current VFC program requirements and recommendations assessed during the visit and any required follow-up actions was provided at the end of the visit
Site visit reviewer
Phone
Reviewer Signature Date
To be completed by the provider
I acknowledge that our practice took part in the VFC site visit noted above I understand the findings of the visit and any required actions that must be taken by our office in order to meet VFC program requirements
Medical Director (or designee) Name Title
Medical Director (or designee) Signature Date
IPI Advisor Manual | February 2017 Page 51
The 2017 MnVFC Site Visit Paperwork Chapter 4
After the Site Visit Send a thank you email highlighting the unmet requirements documents you need from the site to resolve the issue(s) and the date you need them Make sure to include the link to the Site Visit Survey (httpssurveyvovicicomseashxs=56206EE334CE0B14)
Please refer to Chapter 3 for more information about future follow-up required after the visit including forms and documentation
Resource bull Sample Thank You letter on IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml)
Chapter 5
IPI Advisor Resource List MnVFC Program 651-201-5522
MnVFC wwwhealthstatemnusvfc
bull Separate Stock and Replacement Method Policies and Procedures Manuals bull Online trainings bull MnVFC Announcements sign up to receive them via email bull Ordering MDH vaccine bull MnVFC forms Screening forms Reporting forms Others MDH Nonviable Vaccine Form MDH Vaccine Transfer Record and Vaccine Borrowing Report
bull MnVFC promotional materials bull Immunization Billing Guidance for MnVFC and Immunization Billing Guidance for MnVFC Replacement Sites Immunization Practices Improvement Program (IPI) wwwhealthstatemnusdivsidepcimmunizeipi
bull IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml) bull IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml) IPI Resource Folder Contents (wwwhealthstatemnusdivsidepcimmunizeipiipifolderpdf)
Minnesota Immunization Information Connection (MIIC) wwwhealthstatemnusmiic
bull MIIC regions and regional coordinators
Clinical Practice MDH Immunization Program wwwhealthstatemnusimmunize
Got Your Shots News wwwhealthstatemnusdivsidepcnewslettersgys
MDH Immunization Information for Health Care Providers wwwhealthstatemnusdivsidepcimmunizehcp
bull Got Your Shots A Providers Guide to Immunization in Minnesota bull Vaccine protocols bull Forms for tracking patient immunizations bull Immunization schedules for Health Care Providers Immunization Action Coalition (IAC) wwwimmunizeorg
bull Ask the Experts bull VISs (Vaccine Information Statements and translations) bull Administration screening questions bull Medical management of vaccine reactions bull Order form for Californiarsquos Immunization Technique DVD Best Practices with Infants Children and Adults
Page 52 IPI Advisor Manual| February 2017
IPI Advisor Resource List Chapter 5
CDC ldquoPink Bookrdquo wwwcdcgovvaccinespubspinkbookindexhtml
CDC Advisory Committee on Immunization Practices (ACIP) wwwcdcgovvaccinesacip
CDC Vaccines and Immunizations wwwcdcgovvaccines
VAERS reporting httpvaershhsgovindex
Storage and Handling Got Your Shots Providers Guide ndash Managing Vaccine wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml
MnVFC Guide to Temperature Monitoring Devices wwwhealthstatemnusvfc
MDH Clinicianrsquos Vaccine Mishap Checklist wwwhealthstatemnusdivsidepcimmunizeipivaxchklstpdf
MDH Vaccine Storage Guide wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml
CDC Vaccine Storage and Handling Toolkit wwwcdcgovvaccinesrecsstoragetoolkit
You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Vaccine manufacturer phone numbers wwwcdcgovvaccinespubspinkbookdownloadsappendicesFcontact-info-manufactpdf
IAC Checklist for Safe Vaccine Handling and Storage wwwimmunizeorgcatgdp3035pdf
IAC Donrsquot Be Guilty of These Errors in Vaccine Storage and Handling wwwimmunizeorgcatgdp3036pdf
Additional Resources Print materials from MDH ndash order forms wwwhealthstatemnusdivsidepcimmunizeordermathtml
Vaccine Education Center ndash Childrenrsquos Hospital of Philadelphia wwwchopeduservicevaccine-education-centerhomehtml
California Department of Public Health ndash Interactive training on vaccine administration and storage and handling handout on transporting vaccine and how to package wwwezizorg
IPI Advisor Manual | February 2017 Page 53
IPI Advisor Resource List Chapter 5
CDC vaccine price list wwwcdcgovvaccinesprogramsvfcawardeesvaccine-managementprice-listindexhtml
Vaccine Information Statements (VIS) wwwcdcgovvaccineshcpvisindexhtml
CEU Opportunities CDC Immunization Education and Training wwwcdcgovvaccinesedindexhtml
Immunization You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Page 54 IPI Advisor Manual| February 2017
- Introduction
-
- Welcome to the Immunization Practice Improvement (IPI) Program
- Contact Information
-
- Chapter 1
- Requirements to Participate in the MnVFC Program
- Vaccines for Children Program
- Chapter 2
- Reimbursement for MnVFC Visits
- Types of Visits
- Your MnVFC Clinical CoordinatorPlanner
- New IPI Advisor Training Requirements
- Your Role as an IPI Advisor
- Reasons MDH Would Do All or Part of a Visit
- Chapter 3
- Future follow-up
- Conducting the Visit
- Preparing for the Visit
- Information for the Visit
- Site Visit Checklist
- Scheduling the Visit
- Chapter 4
- After the Site Visit
- MnVFC Provider Follow-up Plan
- MnVFC Site Visit Storage and Handling Per Unit Answer Sheet
- Section 6 Inventory
- Section 5 Storage amp Handling Site-Wide
- Section 4 Storage amp Handling Per Unit
- Section 3 Documentation
- Section 2 Eligibility
- Section 1 Provider Details
- The Site Visit Reviewer Legend
- MnVFC Site Visit Questionnaire
- Required Paperwork for Site Visits
- Chapter 5
-
Page 44 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 545 Storage amp Handling Site Wide Expired Vaccines
Question 54 Look in each unit Are there expired vaccines in any of the vaccine storage units at this site
Answers (Choose one)
Yes [X] No
Review CDC Requirement
Vaccines should be rotated weekly and when a new shipment comes in so that longer-dated vaccines are stored behind shorter-dated vaccines If vaccines expire they can no longer be stored in the same storage unit with viable vaccines They must be placedin a container or bag clearly labeled ldquoDo not userdquo and separated from viable vaccines to prevent inadvertent use Expired vaccinemust be returned to the centralized distributor within six months of expiration
Goal of this question Ensure there is no expired vaccine in any storage unit
Helpful information bull Sites can prevent their stock from expiring by rotating vaccines every week andor when a new shipment arrives Longer-dated vaccines are stored towards the back of the unit and shorter-dated vaccines are up front
bull Pay attention to vaccines that expire within the next three months Consider transferring vaccine that will expire soon to another MnVFC-enrolled site that will use the vaccine preferably a site close by It is the transferring sitersquos responsibility to arrange the transfer of the vaccine Be sure to complete the MDH Vaccine Transfer Record form and send it to MDH If they are having difficulty finding a location to accept vaccine contact MDH
bull This is a great opportunity to educate sites about the MDH Nonviable Vaccine Form and the process for returning vaccine The VFC program does get some credit for taxes and fees on vaccine that is returned to the distribution center
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MDH Nonviable Vaccine Form and MDH Vaccine Transfer Record on MnVFC Forms (wwwhealthstatemnusdivsidepcimmunizemnvfcformshtml)
IPI Advisor Manual | February 2017 Page 45
The 2017 MnVFC Site Visit Paperwork Chapter 4
- -
-
Question 555 Storage amp Handling Site Wide Back up Thermometer
Question 55 Does the provider have a readily available back-up thermometer with a current and valid certificate ofcalibration testing
Note to Reviewer ldquoReadily availablerdquo means that the thermometer is available to perform twice-a-day monitoring for a unit asrequired CDC recommends that the back-up thermometer be maintained on site
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have a readily available back-up thermometer with a current and valid certificate of calibration testing Toprevent the certificates of calibration testing of the primary and back-up thermometers from expiring at the same time the date of calibration testing (or issue date) of the back-up thermometer should be different from the date of calibration testing (or issue date) of the primary thermometer As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meetsVFC program requirements
Goal of this question Ensure sites have one calibrated back-up thermometer onsite that is readily available in the event that the temperature monitoring device in unit fails transportation of vaccine is needed or there are other unexpected circumstances
Helpful information bull As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meets VFC Program requirements
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 56 5 Storage amp Handling Site Wide Preparation of Vaccine
Question 56 When does this provider prepare vaccine for administration to the patient
Note to Reviewer For mass vaccination clinics if one type of vaccine is offered providers may pre-draw up to 10 doses Ifusing pre-filled syringes pre-drawing also means activating the syringe by removing the needle guard orattaching a needle
Answers (Choose all that
apply)
Prepare dose immediately before administration Pre-draw doses for upcoming patients (in a regular clinicpractice) [O] Pre-draw up to 10 doses (in a mass-vaccination clinic) Pre-draw more than 10 doses (in a mass-vaccination clinic) [O] Other [O]
Review CDC Recommendation
CDC recommends preparing vaccines immediately prior to administration in order to assure viability of vaccine and prevent vaccinewastage Vaccines that are not administered immediately are at risk of exposure to temperatures outside of the required rangewhich can affect vaccine viability and ultimately can leave children unprotected against vaccine-preventable diseases
Goal of this question Discuss proper timing and preparation of vaccine(s) for administration These are recommendations not requirements
Helpful information bull Educate staff on the importance of preparing vaccine immediately before administration Pre-drawing of vaccines may lead to concerns related to vaccine viability potency sterility and wastage
Page 46 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 6 Inventory Question 61
6 Inventory Inventory Comparison
Question 61 Visually inspect storage units to determine if existing supply of vaccines proportionately mirrorspopulations served Choose the most accurate statement below
Note to Reviewer bull CDC recommends that providers maintain a four-week supply of inventory bull For this question do not take into account vaccine types that the provider does not order Here simply
make sure that overall the vaccines in the providerrsquos storage units are available in sufficient amounts toserve their patient population
Answers (Choose one)
The current vaccine inventory proportionately reflects the populations identified Only public stock is insufficient [X] Only private stock is insufficient [X] Both public and private stock are insufficient [X] Site uses the replacement method but does not appear to have enough vaccine for their population [X] Other [X]
Review CDC Requirement
VFC providers must order and stock routine vaccines in accordance with their patient population in order to prevent missedvaccination opportunities Having sufficient amounts of all stocks prevents the inadvertent use of VFC vaccines for non-VFC-eligiblepatients and vice versa
Goal of this question Assess whether the site is ordering appropriate quantities of vaccine for the population they serve at their site
Helpful information bull If the site sees 30 percent private-pay patients and 70 percent VFC the stock in their storage units should reflect that proportion If you donrsquot know you can ask the site about their population
bull This is meant to be a general assessment so in a big site if they have only a small amount of vaccine that may indicate an issue with vaccine management
bull CDC recommends smaller more frequent orders (ie monthly) rather than large orders to minimize the amount of vaccine loss if an incident occurs during shipment or in the storage unit Sites should not order more frequently than once a month
bull Sites using the replacement method will only have one stock but it should appear to be large enough for their population
bull Only assess the vaccine types that the site currently stocks in their unit We know there are sites that do not offer all ACIP-recommended vaccines for various reasons That issue will be addressed in question 62
IPI Advisor Manual | February 2017 Page 47
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 626 Inventory ACIP Recommended Vaccines
Question 62 Review providerrsquos current inventory to answer the questions below
A Does the provider offer all routine ACIP-recommendedvaccines for their patient population
Yes (Skip to question C) No [X] Offers all except varicella because direct ship ofvaccine is unavailable from manufacturer
B Which routine vaccines are NOT being offered DTaP Hepatitis A Hepatitis B HIB HPV Influenza Meningococcal
MMR Pneumococcal Polio Rotavirus TdapTd Varicella
C According to Immunization Program Policy does theprovider make accessible all non-routine ACIP-recommended vaccines for those VFC patients whomeet the criteria for receiving them
Yes (Skip to question 63) No [X]
D Which non-routine vaccines are NOT being offered Pneumococcal polysaccharide vaccine (PPSV23) Meningococcal Group B (MenB) Other
Review CDC Requirement
VFC providers agree to comply with immunization schedules dosages and contraindications that are established by the Advisory Committee on Immunization Practices (ACIP) for the vaccines identified and agreed upon in the Provider Agreement UNLESS bull In the VFC providers medical judgment and in accordance with accepted medical practice the VFC provider deems such
compliance to be medically inappropriate for the child bull The particular requirements contradict state law including laws pertaining to religious and other exemptions The VFC program entitles children to the following vaccines DTaP Hepatitis A Hepatitis B HIB HPV Influenza MeningococcalMMR Pneumococcal Polio Rotavirus TdapTd and Varicella VFC providers are also required to ensure that VFC-eligible children have access to non-routine vaccines as needed
Goal of this question Assess if the site is offering all the ACIP-recommended vaccines for the population they serve and these vaccines are in stock on the day of the visit It is important that every MnVFC-eligible child that comes to a providerrsquos office for an immunization is vaccinated
Helpful information bull The Advisory Committee on Immunization Practices (ACIP) is a group of medical and public health experts that develops recommendations on how to use vaccines to control diseases in the United States
bull Specialty providers are not required to offer all routine vaccines but should provide the vaccines appropriate for their population
bull If the site does not offer all routine ACIP-recommended vaccines appropriate for their population check the ldquoNordquo box in Part A then check the appropriate box(es) in Part B for any vaccines not offered Please contact MDH as this situation offers us the opportunity to provide education to the site
bull For non-routine vaccines they must either be in stock or the site must have an alternative protocol in the routine management plan that ensures these children have access when applicable
Resources bull IAC Diseases and Vaccines (wwwimmunizeorgvaccines) bull CDC Advisory Committee on Immunization Practices (ACIP) (wwwcdcgovvaccinesacipindexhtml)
Page 48 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 636 Inventory Separation of Stock
Question 63 Observe how the provider differentiates stock in each storage unit to answer the questions below
A Is it clear which vaccines belong to public stock andwhich belong to private stock
Yes No [X] Not applicable replacement site
B Is it clear which vaccines belong to VFC stock andwhich belong to UUAV stock
Yes No [X] Not applicable replacement site Not applicable not UUAV-enrolled site
Review CDC Requirement
In order to ensure that VFC vaccines are only administered to VFC-eligible children VFC providers that serve both VFC and non-VFCshyeligible children must maintain their vaccine inventories in such a way that they can clearly differentiate public stock from privatestock as well as VFC from other public stock
Goal of this question Assess whether the site can distinguish between MnVFC vaccine and private vaccine If they participate in the Uninsured and Underinsured Adult Vaccine (UUAV) program they should also be able to distinguish between MnVFC stock and UUAV stock Some sites use labels bins boxes etc to differentiate their stock If it is not clear how the site differentiates their stock discuss vaccine management with the staff For follow-up call MDH to discuss doing a follow-up site visit
Sites using the replacement method will not have separate stocksmdashthis is an approved alternative method for keeping track of vaccine
Resource bull Section 10 of the MnVFC Policy and Procedure Manual
IPI Advisor Manual | February 2017 Page 49
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
MnVFC Site Visit Storage and Handling Per Unit Answer Sheet 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet MnVFC PIN ___________________
Question number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
Temperature Monitoring Device Questions Questions 43 47 must be answered separately for the freezer and refrigerator if the unit is a combo Be sure to document responses in the appropriate column
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
All the questions on the Site Visit Storage amp Handling Per Unit Answer Sheet have been discussed previously in section 4 of this manual Use this sheet to record information about all the units at the site visit You will need one sheet for each unit If it is a combination unit (either pharmaceutical or household) you can record both sections on one sheet If they have stand-alone units use one sheet for each unit Do not enter the answers to the questions in section 4 of the questionnaire
If you need more information about any of the questions refer back to the main questionnairemdashthe complete question additional guidance including notes to the reviewer and the CDC requirements are there Also if the site is not meeting the requirement you will go back to the questionnaire to complete the ldquoActions if Non-compliantrdquo section including the root cause analysis and follow-up sections
When you have completed the assessment of all the storage units remember to go back to the questionnaire to complete sections 5 and 6
Page 50 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
ndash
ndash
MnVFC Provider Follow-up PlanThe goal of the Provider Follow-up Plan is to communicate with the site all of the VFC requirements any unmet requirements found during your site visit and the timeline for completing the required action The left hand column is a box to check for ldquoUnmetrdquo requirements
Helpful information bull The form can be used to review what the site is doing well and what they need to work on
bull For requirements that have specific documentation that needs to be sent to you use the notes section
2017 MnVFC Provider Follow-up Plan Site _______________________________________________ MnVFC PIN ____________ Date of Visit ___________
Thank you for participating in this MnVFC compliance site visit Please review this visit summary including follow-up actions and timelines for completion Unmet MnVFC requirements and recommendations have a checked box next to them The goal of this plan is to support you with successfully implementing the program and improving access to vaccines for VFC-eligible children
Unmet Question VFC Requirements Section 1 Changes to Key Staff
Q12 Change in the Medical Director Immunization Manager Vaccine Coordinator or back-upKey Staff must be communicated to the immunization program by emailing healthmnvfcstatemnus Changes Notes
Q12 Key staff must complete the annual training on VFC program requirements and print theAnnual Training certificate of completion Documentation Required Action
Staff that have not completed the MnVFC online training must complete it and send acopy of the certificate to the reviewer Training can be found on the MnVFC website (wwwhealthstatemnusvfc) Due date 1 month
Notes
Unmet Question VFC Requirements Section 2 Eligibility
Q21 Provider staff must possess a working knowledge of all VFC eligibility criteria and use thoseVFC Eligibility criteria to screen children prior to administering VFC vaccines
Categories Notes
bull This form provides documentation needed for follow-up actions when you send your thank you email
The second to last page of the Provider Follow-up Plan has a summary of the MnVFC program recommendations These are to remind the site about best practices they may want to improve upon even though they are not yet requirements of the program For example you could discuss the recommendation about storage units if they currently have a combination household unit and are using both sections
The last section is for your signature and the person you met with In most sites it will be the immunization manager or vaccine coordinator who signs the form unless the medical director attended the site visit You keep the original copy and the site will need to keep a copy for themselves
To be completed by the site visit reviewer
I acknowledge that a VFC site visit was performed on __________________ (visit date) The follow-up plan which includes a list of all current VFC program requirements and recommendations assessed during the visit and any required follow-up actions was provided at the end of the visit
Site visit reviewer
Phone
Reviewer Signature Date
To be completed by the provider
I acknowledge that our practice took part in the VFC site visit noted above I understand the findings of the visit and any required actions that must be taken by our office in order to meet VFC program requirements
Medical Director (or designee) Name Title
Medical Director (or designee) Signature Date
IPI Advisor Manual | February 2017 Page 51
The 2017 MnVFC Site Visit Paperwork Chapter 4
After the Site Visit Send a thank you email highlighting the unmet requirements documents you need from the site to resolve the issue(s) and the date you need them Make sure to include the link to the Site Visit Survey (httpssurveyvovicicomseashxs=56206EE334CE0B14)
Please refer to Chapter 3 for more information about future follow-up required after the visit including forms and documentation
Resource bull Sample Thank You letter on IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml)
Chapter 5
IPI Advisor Resource List MnVFC Program 651-201-5522
MnVFC wwwhealthstatemnusvfc
bull Separate Stock and Replacement Method Policies and Procedures Manuals bull Online trainings bull MnVFC Announcements sign up to receive them via email bull Ordering MDH vaccine bull MnVFC forms Screening forms Reporting forms Others MDH Nonviable Vaccine Form MDH Vaccine Transfer Record and Vaccine Borrowing Report
bull MnVFC promotional materials bull Immunization Billing Guidance for MnVFC and Immunization Billing Guidance for MnVFC Replacement Sites Immunization Practices Improvement Program (IPI) wwwhealthstatemnusdivsidepcimmunizeipi
bull IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml) bull IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml) IPI Resource Folder Contents (wwwhealthstatemnusdivsidepcimmunizeipiipifolderpdf)
Minnesota Immunization Information Connection (MIIC) wwwhealthstatemnusmiic
bull MIIC regions and regional coordinators
Clinical Practice MDH Immunization Program wwwhealthstatemnusimmunize
Got Your Shots News wwwhealthstatemnusdivsidepcnewslettersgys
MDH Immunization Information for Health Care Providers wwwhealthstatemnusdivsidepcimmunizehcp
bull Got Your Shots A Providers Guide to Immunization in Minnesota bull Vaccine protocols bull Forms for tracking patient immunizations bull Immunization schedules for Health Care Providers Immunization Action Coalition (IAC) wwwimmunizeorg
bull Ask the Experts bull VISs (Vaccine Information Statements and translations) bull Administration screening questions bull Medical management of vaccine reactions bull Order form for Californiarsquos Immunization Technique DVD Best Practices with Infants Children and Adults
Page 52 IPI Advisor Manual| February 2017
IPI Advisor Resource List Chapter 5
CDC ldquoPink Bookrdquo wwwcdcgovvaccinespubspinkbookindexhtml
CDC Advisory Committee on Immunization Practices (ACIP) wwwcdcgovvaccinesacip
CDC Vaccines and Immunizations wwwcdcgovvaccines
VAERS reporting httpvaershhsgovindex
Storage and Handling Got Your Shots Providers Guide ndash Managing Vaccine wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml
MnVFC Guide to Temperature Monitoring Devices wwwhealthstatemnusvfc
MDH Clinicianrsquos Vaccine Mishap Checklist wwwhealthstatemnusdivsidepcimmunizeipivaxchklstpdf
MDH Vaccine Storage Guide wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml
CDC Vaccine Storage and Handling Toolkit wwwcdcgovvaccinesrecsstoragetoolkit
You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Vaccine manufacturer phone numbers wwwcdcgovvaccinespubspinkbookdownloadsappendicesFcontact-info-manufactpdf
IAC Checklist for Safe Vaccine Handling and Storage wwwimmunizeorgcatgdp3035pdf
IAC Donrsquot Be Guilty of These Errors in Vaccine Storage and Handling wwwimmunizeorgcatgdp3036pdf
Additional Resources Print materials from MDH ndash order forms wwwhealthstatemnusdivsidepcimmunizeordermathtml
Vaccine Education Center ndash Childrenrsquos Hospital of Philadelphia wwwchopeduservicevaccine-education-centerhomehtml
California Department of Public Health ndash Interactive training on vaccine administration and storage and handling handout on transporting vaccine and how to package wwwezizorg
IPI Advisor Manual | February 2017 Page 53
IPI Advisor Resource List Chapter 5
CDC vaccine price list wwwcdcgovvaccinesprogramsvfcawardeesvaccine-managementprice-listindexhtml
Vaccine Information Statements (VIS) wwwcdcgovvaccineshcpvisindexhtml
CEU Opportunities CDC Immunization Education and Training wwwcdcgovvaccinesedindexhtml
Immunization You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Page 54 IPI Advisor Manual| February 2017
- Introduction
-
- Welcome to the Immunization Practice Improvement (IPI) Program
- Contact Information
-
- Chapter 1
- Requirements to Participate in the MnVFC Program
- Vaccines for Children Program
- Chapter 2
- Reimbursement for MnVFC Visits
- Types of Visits
- Your MnVFC Clinical CoordinatorPlanner
- New IPI Advisor Training Requirements
- Your Role as an IPI Advisor
- Reasons MDH Would Do All or Part of a Visit
- Chapter 3
- Future follow-up
- Conducting the Visit
- Preparing for the Visit
- Information for the Visit
- Site Visit Checklist
- Scheduling the Visit
- Chapter 4
- After the Site Visit
- MnVFC Provider Follow-up Plan
- MnVFC Site Visit Storage and Handling Per Unit Answer Sheet
- Section 6 Inventory
- Section 5 Storage amp Handling Site-Wide
- Section 4 Storage amp Handling Per Unit
- Section 3 Documentation
- Section 2 Eligibility
- Section 1 Provider Details
- The Site Visit Reviewer Legend
- MnVFC Site Visit Questionnaire
- Required Paperwork for Site Visits
- Chapter 5
-
IPI Advisor Manual | February 2017 Page 45
The 2017 MnVFC Site Visit Paperwork Chapter 4
- -
-
Question 555 Storage amp Handling Site Wide Back up Thermometer
Question 55 Does the provider have a readily available back-up thermometer with a current and valid certificate ofcalibration testing
Note to Reviewer ldquoReadily availablerdquo means that the thermometer is available to perform twice-a-day monitoring for a unit asrequired CDC recommends that the back-up thermometer be maintained on site
Answers (Choose one)
Yes No [X]
Review CDC Requirement
VFC providers must have a readily available back-up thermometer with a current and valid certificate of calibration testing Toprevent the certificates of calibration testing of the primary and back-up thermometers from expiring at the same time the date of calibration testing (or issue date) of the back-up thermometer should be different from the date of calibration testing (or issue date) of the primary thermometer As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meetsVFC program requirements
Goal of this question Ensure sites have one calibrated back-up thermometer onsite that is readily available in the event that the temperature monitoring device in unit fails transportation of vaccine is needed or there are other unexpected circumstances
Helpful information bull As of Jan 1 2018 all devices in use including back-up devices must be a continuous monitoring and recording device that meets VFC Program requirements
Resources bull Section 10 in the MnVFC Policies and Procedures Manual bull MnVFC Guide to Temperature Monitoring Devices on MnVFC website (wwwhealthstatemnusvfc)
Question 56 5 Storage amp Handling Site Wide Preparation of Vaccine
Question 56 When does this provider prepare vaccine for administration to the patient
Note to Reviewer For mass vaccination clinics if one type of vaccine is offered providers may pre-draw up to 10 doses Ifusing pre-filled syringes pre-drawing also means activating the syringe by removing the needle guard orattaching a needle
Answers (Choose all that
apply)
Prepare dose immediately before administration Pre-draw doses for upcoming patients (in a regular clinicpractice) [O] Pre-draw up to 10 doses (in a mass-vaccination clinic) Pre-draw more than 10 doses (in a mass-vaccination clinic) [O] Other [O]
Review CDC Recommendation
CDC recommends preparing vaccines immediately prior to administration in order to assure viability of vaccine and prevent vaccinewastage Vaccines that are not administered immediately are at risk of exposure to temperatures outside of the required rangewhich can affect vaccine viability and ultimately can leave children unprotected against vaccine-preventable diseases
Goal of this question Discuss proper timing and preparation of vaccine(s) for administration These are recommendations not requirements
Helpful information bull Educate staff on the importance of preparing vaccine immediately before administration Pre-drawing of vaccines may lead to concerns related to vaccine viability potency sterility and wastage
Page 46 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 6 Inventory Question 61
6 Inventory Inventory Comparison
Question 61 Visually inspect storage units to determine if existing supply of vaccines proportionately mirrorspopulations served Choose the most accurate statement below
Note to Reviewer bull CDC recommends that providers maintain a four-week supply of inventory bull For this question do not take into account vaccine types that the provider does not order Here simply
make sure that overall the vaccines in the providerrsquos storage units are available in sufficient amounts toserve their patient population
Answers (Choose one)
The current vaccine inventory proportionately reflects the populations identified Only public stock is insufficient [X] Only private stock is insufficient [X] Both public and private stock are insufficient [X] Site uses the replacement method but does not appear to have enough vaccine for their population [X] Other [X]
Review CDC Requirement
VFC providers must order and stock routine vaccines in accordance with their patient population in order to prevent missedvaccination opportunities Having sufficient amounts of all stocks prevents the inadvertent use of VFC vaccines for non-VFC-eligiblepatients and vice versa
Goal of this question Assess whether the site is ordering appropriate quantities of vaccine for the population they serve at their site
Helpful information bull If the site sees 30 percent private-pay patients and 70 percent VFC the stock in their storage units should reflect that proportion If you donrsquot know you can ask the site about their population
bull This is meant to be a general assessment so in a big site if they have only a small amount of vaccine that may indicate an issue with vaccine management
bull CDC recommends smaller more frequent orders (ie monthly) rather than large orders to minimize the amount of vaccine loss if an incident occurs during shipment or in the storage unit Sites should not order more frequently than once a month
bull Sites using the replacement method will only have one stock but it should appear to be large enough for their population
bull Only assess the vaccine types that the site currently stocks in their unit We know there are sites that do not offer all ACIP-recommended vaccines for various reasons That issue will be addressed in question 62
IPI Advisor Manual | February 2017 Page 47
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 626 Inventory ACIP Recommended Vaccines
Question 62 Review providerrsquos current inventory to answer the questions below
A Does the provider offer all routine ACIP-recommendedvaccines for their patient population
Yes (Skip to question C) No [X] Offers all except varicella because direct ship ofvaccine is unavailable from manufacturer
B Which routine vaccines are NOT being offered DTaP Hepatitis A Hepatitis B HIB HPV Influenza Meningococcal
MMR Pneumococcal Polio Rotavirus TdapTd Varicella
C According to Immunization Program Policy does theprovider make accessible all non-routine ACIP-recommended vaccines for those VFC patients whomeet the criteria for receiving them
Yes (Skip to question 63) No [X]
D Which non-routine vaccines are NOT being offered Pneumococcal polysaccharide vaccine (PPSV23) Meningococcal Group B (MenB) Other
Review CDC Requirement
VFC providers agree to comply with immunization schedules dosages and contraindications that are established by the Advisory Committee on Immunization Practices (ACIP) for the vaccines identified and agreed upon in the Provider Agreement UNLESS bull In the VFC providers medical judgment and in accordance with accepted medical practice the VFC provider deems such
compliance to be medically inappropriate for the child bull The particular requirements contradict state law including laws pertaining to religious and other exemptions The VFC program entitles children to the following vaccines DTaP Hepatitis A Hepatitis B HIB HPV Influenza MeningococcalMMR Pneumococcal Polio Rotavirus TdapTd and Varicella VFC providers are also required to ensure that VFC-eligible children have access to non-routine vaccines as needed
Goal of this question Assess if the site is offering all the ACIP-recommended vaccines for the population they serve and these vaccines are in stock on the day of the visit It is important that every MnVFC-eligible child that comes to a providerrsquos office for an immunization is vaccinated
Helpful information bull The Advisory Committee on Immunization Practices (ACIP) is a group of medical and public health experts that develops recommendations on how to use vaccines to control diseases in the United States
bull Specialty providers are not required to offer all routine vaccines but should provide the vaccines appropriate for their population
bull If the site does not offer all routine ACIP-recommended vaccines appropriate for their population check the ldquoNordquo box in Part A then check the appropriate box(es) in Part B for any vaccines not offered Please contact MDH as this situation offers us the opportunity to provide education to the site
bull For non-routine vaccines they must either be in stock or the site must have an alternative protocol in the routine management plan that ensures these children have access when applicable
Resources bull IAC Diseases and Vaccines (wwwimmunizeorgvaccines) bull CDC Advisory Committee on Immunization Practices (ACIP) (wwwcdcgovvaccinesacipindexhtml)
Page 48 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 636 Inventory Separation of Stock
Question 63 Observe how the provider differentiates stock in each storage unit to answer the questions below
A Is it clear which vaccines belong to public stock andwhich belong to private stock
Yes No [X] Not applicable replacement site
B Is it clear which vaccines belong to VFC stock andwhich belong to UUAV stock
Yes No [X] Not applicable replacement site Not applicable not UUAV-enrolled site
Review CDC Requirement
In order to ensure that VFC vaccines are only administered to VFC-eligible children VFC providers that serve both VFC and non-VFCshyeligible children must maintain their vaccine inventories in such a way that they can clearly differentiate public stock from privatestock as well as VFC from other public stock
Goal of this question Assess whether the site can distinguish between MnVFC vaccine and private vaccine If they participate in the Uninsured and Underinsured Adult Vaccine (UUAV) program they should also be able to distinguish between MnVFC stock and UUAV stock Some sites use labels bins boxes etc to differentiate their stock If it is not clear how the site differentiates their stock discuss vaccine management with the staff For follow-up call MDH to discuss doing a follow-up site visit
Sites using the replacement method will not have separate stocksmdashthis is an approved alternative method for keeping track of vaccine
Resource bull Section 10 of the MnVFC Policy and Procedure Manual
IPI Advisor Manual | February 2017 Page 49
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
MnVFC Site Visit Storage and Handling Per Unit Answer Sheet 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet MnVFC PIN ___________________
Question number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
Temperature Monitoring Device Questions Questions 43 47 must be answered separately for the freezer and refrigerator if the unit is a combo Be sure to document responses in the appropriate column
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
All the questions on the Site Visit Storage amp Handling Per Unit Answer Sheet have been discussed previously in section 4 of this manual Use this sheet to record information about all the units at the site visit You will need one sheet for each unit If it is a combination unit (either pharmaceutical or household) you can record both sections on one sheet If they have stand-alone units use one sheet for each unit Do not enter the answers to the questions in section 4 of the questionnaire
If you need more information about any of the questions refer back to the main questionnairemdashthe complete question additional guidance including notes to the reviewer and the CDC requirements are there Also if the site is not meeting the requirement you will go back to the questionnaire to complete the ldquoActions if Non-compliantrdquo section including the root cause analysis and follow-up sections
When you have completed the assessment of all the storage units remember to go back to the questionnaire to complete sections 5 and 6
Page 50 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
ndash
ndash
MnVFC Provider Follow-up PlanThe goal of the Provider Follow-up Plan is to communicate with the site all of the VFC requirements any unmet requirements found during your site visit and the timeline for completing the required action The left hand column is a box to check for ldquoUnmetrdquo requirements
Helpful information bull The form can be used to review what the site is doing well and what they need to work on
bull For requirements that have specific documentation that needs to be sent to you use the notes section
2017 MnVFC Provider Follow-up Plan Site _______________________________________________ MnVFC PIN ____________ Date of Visit ___________
Thank you for participating in this MnVFC compliance site visit Please review this visit summary including follow-up actions and timelines for completion Unmet MnVFC requirements and recommendations have a checked box next to them The goal of this plan is to support you with successfully implementing the program and improving access to vaccines for VFC-eligible children
Unmet Question VFC Requirements Section 1 Changes to Key Staff
Q12 Change in the Medical Director Immunization Manager Vaccine Coordinator or back-upKey Staff must be communicated to the immunization program by emailing healthmnvfcstatemnus Changes Notes
Q12 Key staff must complete the annual training on VFC program requirements and print theAnnual Training certificate of completion Documentation Required Action
Staff that have not completed the MnVFC online training must complete it and send acopy of the certificate to the reviewer Training can be found on the MnVFC website (wwwhealthstatemnusvfc) Due date 1 month
Notes
Unmet Question VFC Requirements Section 2 Eligibility
Q21 Provider staff must possess a working knowledge of all VFC eligibility criteria and use thoseVFC Eligibility criteria to screen children prior to administering VFC vaccines
Categories Notes
bull This form provides documentation needed for follow-up actions when you send your thank you email
The second to last page of the Provider Follow-up Plan has a summary of the MnVFC program recommendations These are to remind the site about best practices they may want to improve upon even though they are not yet requirements of the program For example you could discuss the recommendation about storage units if they currently have a combination household unit and are using both sections
The last section is for your signature and the person you met with In most sites it will be the immunization manager or vaccine coordinator who signs the form unless the medical director attended the site visit You keep the original copy and the site will need to keep a copy for themselves
To be completed by the site visit reviewer
I acknowledge that a VFC site visit was performed on __________________ (visit date) The follow-up plan which includes a list of all current VFC program requirements and recommendations assessed during the visit and any required follow-up actions was provided at the end of the visit
Site visit reviewer
Phone
Reviewer Signature Date
To be completed by the provider
I acknowledge that our practice took part in the VFC site visit noted above I understand the findings of the visit and any required actions that must be taken by our office in order to meet VFC program requirements
Medical Director (or designee) Name Title
Medical Director (or designee) Signature Date
IPI Advisor Manual | February 2017 Page 51
The 2017 MnVFC Site Visit Paperwork Chapter 4
After the Site Visit Send a thank you email highlighting the unmet requirements documents you need from the site to resolve the issue(s) and the date you need them Make sure to include the link to the Site Visit Survey (httpssurveyvovicicomseashxs=56206EE334CE0B14)
Please refer to Chapter 3 for more information about future follow-up required after the visit including forms and documentation
Resource bull Sample Thank You letter on IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml)
Chapter 5
IPI Advisor Resource List MnVFC Program 651-201-5522
MnVFC wwwhealthstatemnusvfc
bull Separate Stock and Replacement Method Policies and Procedures Manuals bull Online trainings bull MnVFC Announcements sign up to receive them via email bull Ordering MDH vaccine bull MnVFC forms Screening forms Reporting forms Others MDH Nonviable Vaccine Form MDH Vaccine Transfer Record and Vaccine Borrowing Report
bull MnVFC promotional materials bull Immunization Billing Guidance for MnVFC and Immunization Billing Guidance for MnVFC Replacement Sites Immunization Practices Improvement Program (IPI) wwwhealthstatemnusdivsidepcimmunizeipi
bull IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml) bull IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml) IPI Resource Folder Contents (wwwhealthstatemnusdivsidepcimmunizeipiipifolderpdf)
Minnesota Immunization Information Connection (MIIC) wwwhealthstatemnusmiic
bull MIIC regions and regional coordinators
Clinical Practice MDH Immunization Program wwwhealthstatemnusimmunize
Got Your Shots News wwwhealthstatemnusdivsidepcnewslettersgys
MDH Immunization Information for Health Care Providers wwwhealthstatemnusdivsidepcimmunizehcp
bull Got Your Shots A Providers Guide to Immunization in Minnesota bull Vaccine protocols bull Forms for tracking patient immunizations bull Immunization schedules for Health Care Providers Immunization Action Coalition (IAC) wwwimmunizeorg
bull Ask the Experts bull VISs (Vaccine Information Statements and translations) bull Administration screening questions bull Medical management of vaccine reactions bull Order form for Californiarsquos Immunization Technique DVD Best Practices with Infants Children and Adults
Page 52 IPI Advisor Manual| February 2017
IPI Advisor Resource List Chapter 5
CDC ldquoPink Bookrdquo wwwcdcgovvaccinespubspinkbookindexhtml
CDC Advisory Committee on Immunization Practices (ACIP) wwwcdcgovvaccinesacip
CDC Vaccines and Immunizations wwwcdcgovvaccines
VAERS reporting httpvaershhsgovindex
Storage and Handling Got Your Shots Providers Guide ndash Managing Vaccine wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml
MnVFC Guide to Temperature Monitoring Devices wwwhealthstatemnusvfc
MDH Clinicianrsquos Vaccine Mishap Checklist wwwhealthstatemnusdivsidepcimmunizeipivaxchklstpdf
MDH Vaccine Storage Guide wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml
CDC Vaccine Storage and Handling Toolkit wwwcdcgovvaccinesrecsstoragetoolkit
You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Vaccine manufacturer phone numbers wwwcdcgovvaccinespubspinkbookdownloadsappendicesFcontact-info-manufactpdf
IAC Checklist for Safe Vaccine Handling and Storage wwwimmunizeorgcatgdp3035pdf
IAC Donrsquot Be Guilty of These Errors in Vaccine Storage and Handling wwwimmunizeorgcatgdp3036pdf
Additional Resources Print materials from MDH ndash order forms wwwhealthstatemnusdivsidepcimmunizeordermathtml
Vaccine Education Center ndash Childrenrsquos Hospital of Philadelphia wwwchopeduservicevaccine-education-centerhomehtml
California Department of Public Health ndash Interactive training on vaccine administration and storage and handling handout on transporting vaccine and how to package wwwezizorg
IPI Advisor Manual | February 2017 Page 53
IPI Advisor Resource List Chapter 5
CDC vaccine price list wwwcdcgovvaccinesprogramsvfcawardeesvaccine-managementprice-listindexhtml
Vaccine Information Statements (VIS) wwwcdcgovvaccineshcpvisindexhtml
CEU Opportunities CDC Immunization Education and Training wwwcdcgovvaccinesedindexhtml
Immunization You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Page 54 IPI Advisor Manual| February 2017
- Introduction
-
- Welcome to the Immunization Practice Improvement (IPI) Program
- Contact Information
-
- Chapter 1
- Requirements to Participate in the MnVFC Program
- Vaccines for Children Program
- Chapter 2
- Reimbursement for MnVFC Visits
- Types of Visits
- Your MnVFC Clinical CoordinatorPlanner
- New IPI Advisor Training Requirements
- Your Role as an IPI Advisor
- Reasons MDH Would Do All or Part of a Visit
- Chapter 3
- Future follow-up
- Conducting the Visit
- Preparing for the Visit
- Information for the Visit
- Site Visit Checklist
- Scheduling the Visit
- Chapter 4
- After the Site Visit
- MnVFC Provider Follow-up Plan
- MnVFC Site Visit Storage and Handling Per Unit Answer Sheet
- Section 6 Inventory
- Section 5 Storage amp Handling Site-Wide
- Section 4 Storage amp Handling Per Unit
- Section 3 Documentation
- Section 2 Eligibility
- Section 1 Provider Details
- The Site Visit Reviewer Legend
- MnVFC Site Visit Questionnaire
- Required Paperwork for Site Visits
- Chapter 5
-
Page 46 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Section 6 Inventory Question 61
6 Inventory Inventory Comparison
Question 61 Visually inspect storage units to determine if existing supply of vaccines proportionately mirrorspopulations served Choose the most accurate statement below
Note to Reviewer bull CDC recommends that providers maintain a four-week supply of inventory bull For this question do not take into account vaccine types that the provider does not order Here simply
make sure that overall the vaccines in the providerrsquos storage units are available in sufficient amounts toserve their patient population
Answers (Choose one)
The current vaccine inventory proportionately reflects the populations identified Only public stock is insufficient [X] Only private stock is insufficient [X] Both public and private stock are insufficient [X] Site uses the replacement method but does not appear to have enough vaccine for their population [X] Other [X]
Review CDC Requirement
VFC providers must order and stock routine vaccines in accordance with their patient population in order to prevent missedvaccination opportunities Having sufficient amounts of all stocks prevents the inadvertent use of VFC vaccines for non-VFC-eligiblepatients and vice versa
Goal of this question Assess whether the site is ordering appropriate quantities of vaccine for the population they serve at their site
Helpful information bull If the site sees 30 percent private-pay patients and 70 percent VFC the stock in their storage units should reflect that proportion If you donrsquot know you can ask the site about their population
bull This is meant to be a general assessment so in a big site if they have only a small amount of vaccine that may indicate an issue with vaccine management
bull CDC recommends smaller more frequent orders (ie monthly) rather than large orders to minimize the amount of vaccine loss if an incident occurs during shipment or in the storage unit Sites should not order more frequently than once a month
bull Sites using the replacement method will only have one stock but it should appear to be large enough for their population
bull Only assess the vaccine types that the site currently stocks in their unit We know there are sites that do not offer all ACIP-recommended vaccines for various reasons That issue will be addressed in question 62
IPI Advisor Manual | February 2017 Page 47
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 626 Inventory ACIP Recommended Vaccines
Question 62 Review providerrsquos current inventory to answer the questions below
A Does the provider offer all routine ACIP-recommendedvaccines for their patient population
Yes (Skip to question C) No [X] Offers all except varicella because direct ship ofvaccine is unavailable from manufacturer
B Which routine vaccines are NOT being offered DTaP Hepatitis A Hepatitis B HIB HPV Influenza Meningococcal
MMR Pneumococcal Polio Rotavirus TdapTd Varicella
C According to Immunization Program Policy does theprovider make accessible all non-routine ACIP-recommended vaccines for those VFC patients whomeet the criteria for receiving them
Yes (Skip to question 63) No [X]
D Which non-routine vaccines are NOT being offered Pneumococcal polysaccharide vaccine (PPSV23) Meningococcal Group B (MenB) Other
Review CDC Requirement
VFC providers agree to comply with immunization schedules dosages and contraindications that are established by the Advisory Committee on Immunization Practices (ACIP) for the vaccines identified and agreed upon in the Provider Agreement UNLESS bull In the VFC providers medical judgment and in accordance with accepted medical practice the VFC provider deems such
compliance to be medically inappropriate for the child bull The particular requirements contradict state law including laws pertaining to religious and other exemptions The VFC program entitles children to the following vaccines DTaP Hepatitis A Hepatitis B HIB HPV Influenza MeningococcalMMR Pneumococcal Polio Rotavirus TdapTd and Varicella VFC providers are also required to ensure that VFC-eligible children have access to non-routine vaccines as needed
Goal of this question Assess if the site is offering all the ACIP-recommended vaccines for the population they serve and these vaccines are in stock on the day of the visit It is important that every MnVFC-eligible child that comes to a providerrsquos office for an immunization is vaccinated
Helpful information bull The Advisory Committee on Immunization Practices (ACIP) is a group of medical and public health experts that develops recommendations on how to use vaccines to control diseases in the United States
bull Specialty providers are not required to offer all routine vaccines but should provide the vaccines appropriate for their population
bull If the site does not offer all routine ACIP-recommended vaccines appropriate for their population check the ldquoNordquo box in Part A then check the appropriate box(es) in Part B for any vaccines not offered Please contact MDH as this situation offers us the opportunity to provide education to the site
bull For non-routine vaccines they must either be in stock or the site must have an alternative protocol in the routine management plan that ensures these children have access when applicable
Resources bull IAC Diseases and Vaccines (wwwimmunizeorgvaccines) bull CDC Advisory Committee on Immunization Practices (ACIP) (wwwcdcgovvaccinesacipindexhtml)
Page 48 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 636 Inventory Separation of Stock
Question 63 Observe how the provider differentiates stock in each storage unit to answer the questions below
A Is it clear which vaccines belong to public stock andwhich belong to private stock
Yes No [X] Not applicable replacement site
B Is it clear which vaccines belong to VFC stock andwhich belong to UUAV stock
Yes No [X] Not applicable replacement site Not applicable not UUAV-enrolled site
Review CDC Requirement
In order to ensure that VFC vaccines are only administered to VFC-eligible children VFC providers that serve both VFC and non-VFCshyeligible children must maintain their vaccine inventories in such a way that they can clearly differentiate public stock from privatestock as well as VFC from other public stock
Goal of this question Assess whether the site can distinguish between MnVFC vaccine and private vaccine If they participate in the Uninsured and Underinsured Adult Vaccine (UUAV) program they should also be able to distinguish between MnVFC stock and UUAV stock Some sites use labels bins boxes etc to differentiate their stock If it is not clear how the site differentiates their stock discuss vaccine management with the staff For follow-up call MDH to discuss doing a follow-up site visit
Sites using the replacement method will not have separate stocksmdashthis is an approved alternative method for keeping track of vaccine
Resource bull Section 10 of the MnVFC Policy and Procedure Manual
IPI Advisor Manual | February 2017 Page 49
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
MnVFC Site Visit Storage and Handling Per Unit Answer Sheet 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet MnVFC PIN ___________________
Question number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
Temperature Monitoring Device Questions Questions 43 47 must be answered separately for the freezer and refrigerator if the unit is a combo Be sure to document responses in the appropriate column
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
All the questions on the Site Visit Storage amp Handling Per Unit Answer Sheet have been discussed previously in section 4 of this manual Use this sheet to record information about all the units at the site visit You will need one sheet for each unit If it is a combination unit (either pharmaceutical or household) you can record both sections on one sheet If they have stand-alone units use one sheet for each unit Do not enter the answers to the questions in section 4 of the questionnaire
If you need more information about any of the questions refer back to the main questionnairemdashthe complete question additional guidance including notes to the reviewer and the CDC requirements are there Also if the site is not meeting the requirement you will go back to the questionnaire to complete the ldquoActions if Non-compliantrdquo section including the root cause analysis and follow-up sections
When you have completed the assessment of all the storage units remember to go back to the questionnaire to complete sections 5 and 6
Page 50 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
ndash
ndash
MnVFC Provider Follow-up PlanThe goal of the Provider Follow-up Plan is to communicate with the site all of the VFC requirements any unmet requirements found during your site visit and the timeline for completing the required action The left hand column is a box to check for ldquoUnmetrdquo requirements
Helpful information bull The form can be used to review what the site is doing well and what they need to work on
bull For requirements that have specific documentation that needs to be sent to you use the notes section
2017 MnVFC Provider Follow-up Plan Site _______________________________________________ MnVFC PIN ____________ Date of Visit ___________
Thank you for participating in this MnVFC compliance site visit Please review this visit summary including follow-up actions and timelines for completion Unmet MnVFC requirements and recommendations have a checked box next to them The goal of this plan is to support you with successfully implementing the program and improving access to vaccines for VFC-eligible children
Unmet Question VFC Requirements Section 1 Changes to Key Staff
Q12 Change in the Medical Director Immunization Manager Vaccine Coordinator or back-upKey Staff must be communicated to the immunization program by emailing healthmnvfcstatemnus Changes Notes
Q12 Key staff must complete the annual training on VFC program requirements and print theAnnual Training certificate of completion Documentation Required Action
Staff that have not completed the MnVFC online training must complete it and send acopy of the certificate to the reviewer Training can be found on the MnVFC website (wwwhealthstatemnusvfc) Due date 1 month
Notes
Unmet Question VFC Requirements Section 2 Eligibility
Q21 Provider staff must possess a working knowledge of all VFC eligibility criteria and use thoseVFC Eligibility criteria to screen children prior to administering VFC vaccines
Categories Notes
bull This form provides documentation needed for follow-up actions when you send your thank you email
The second to last page of the Provider Follow-up Plan has a summary of the MnVFC program recommendations These are to remind the site about best practices they may want to improve upon even though they are not yet requirements of the program For example you could discuss the recommendation about storage units if they currently have a combination household unit and are using both sections
The last section is for your signature and the person you met with In most sites it will be the immunization manager or vaccine coordinator who signs the form unless the medical director attended the site visit You keep the original copy and the site will need to keep a copy for themselves
To be completed by the site visit reviewer
I acknowledge that a VFC site visit was performed on __________________ (visit date) The follow-up plan which includes a list of all current VFC program requirements and recommendations assessed during the visit and any required follow-up actions was provided at the end of the visit
Site visit reviewer
Phone
Reviewer Signature Date
To be completed by the provider
I acknowledge that our practice took part in the VFC site visit noted above I understand the findings of the visit and any required actions that must be taken by our office in order to meet VFC program requirements
Medical Director (or designee) Name Title
Medical Director (or designee) Signature Date
IPI Advisor Manual | February 2017 Page 51
The 2017 MnVFC Site Visit Paperwork Chapter 4
After the Site Visit Send a thank you email highlighting the unmet requirements documents you need from the site to resolve the issue(s) and the date you need them Make sure to include the link to the Site Visit Survey (httpssurveyvovicicomseashxs=56206EE334CE0B14)
Please refer to Chapter 3 for more information about future follow-up required after the visit including forms and documentation
Resource bull Sample Thank You letter on IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml)
Chapter 5
IPI Advisor Resource List MnVFC Program 651-201-5522
MnVFC wwwhealthstatemnusvfc
bull Separate Stock and Replacement Method Policies and Procedures Manuals bull Online trainings bull MnVFC Announcements sign up to receive them via email bull Ordering MDH vaccine bull MnVFC forms Screening forms Reporting forms Others MDH Nonviable Vaccine Form MDH Vaccine Transfer Record and Vaccine Borrowing Report
bull MnVFC promotional materials bull Immunization Billing Guidance for MnVFC and Immunization Billing Guidance for MnVFC Replacement Sites Immunization Practices Improvement Program (IPI) wwwhealthstatemnusdivsidepcimmunizeipi
bull IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml) bull IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml) IPI Resource Folder Contents (wwwhealthstatemnusdivsidepcimmunizeipiipifolderpdf)
Minnesota Immunization Information Connection (MIIC) wwwhealthstatemnusmiic
bull MIIC regions and regional coordinators
Clinical Practice MDH Immunization Program wwwhealthstatemnusimmunize
Got Your Shots News wwwhealthstatemnusdivsidepcnewslettersgys
MDH Immunization Information for Health Care Providers wwwhealthstatemnusdivsidepcimmunizehcp
bull Got Your Shots A Providers Guide to Immunization in Minnesota bull Vaccine protocols bull Forms for tracking patient immunizations bull Immunization schedules for Health Care Providers Immunization Action Coalition (IAC) wwwimmunizeorg
bull Ask the Experts bull VISs (Vaccine Information Statements and translations) bull Administration screening questions bull Medical management of vaccine reactions bull Order form for Californiarsquos Immunization Technique DVD Best Practices with Infants Children and Adults
Page 52 IPI Advisor Manual| February 2017
IPI Advisor Resource List Chapter 5
CDC ldquoPink Bookrdquo wwwcdcgovvaccinespubspinkbookindexhtml
CDC Advisory Committee on Immunization Practices (ACIP) wwwcdcgovvaccinesacip
CDC Vaccines and Immunizations wwwcdcgovvaccines
VAERS reporting httpvaershhsgovindex
Storage and Handling Got Your Shots Providers Guide ndash Managing Vaccine wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml
MnVFC Guide to Temperature Monitoring Devices wwwhealthstatemnusvfc
MDH Clinicianrsquos Vaccine Mishap Checklist wwwhealthstatemnusdivsidepcimmunizeipivaxchklstpdf
MDH Vaccine Storage Guide wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml
CDC Vaccine Storage and Handling Toolkit wwwcdcgovvaccinesrecsstoragetoolkit
You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Vaccine manufacturer phone numbers wwwcdcgovvaccinespubspinkbookdownloadsappendicesFcontact-info-manufactpdf
IAC Checklist for Safe Vaccine Handling and Storage wwwimmunizeorgcatgdp3035pdf
IAC Donrsquot Be Guilty of These Errors in Vaccine Storage and Handling wwwimmunizeorgcatgdp3036pdf
Additional Resources Print materials from MDH ndash order forms wwwhealthstatemnusdivsidepcimmunizeordermathtml
Vaccine Education Center ndash Childrenrsquos Hospital of Philadelphia wwwchopeduservicevaccine-education-centerhomehtml
California Department of Public Health ndash Interactive training on vaccine administration and storage and handling handout on transporting vaccine and how to package wwwezizorg
IPI Advisor Manual | February 2017 Page 53
IPI Advisor Resource List Chapter 5
CDC vaccine price list wwwcdcgovvaccinesprogramsvfcawardeesvaccine-managementprice-listindexhtml
Vaccine Information Statements (VIS) wwwcdcgovvaccineshcpvisindexhtml
CEU Opportunities CDC Immunization Education and Training wwwcdcgovvaccinesedindexhtml
Immunization You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Page 54 IPI Advisor Manual| February 2017
- Introduction
-
- Welcome to the Immunization Practice Improvement (IPI) Program
- Contact Information
-
- Chapter 1
- Requirements to Participate in the MnVFC Program
- Vaccines for Children Program
- Chapter 2
- Reimbursement for MnVFC Visits
- Types of Visits
- Your MnVFC Clinical CoordinatorPlanner
- New IPI Advisor Training Requirements
- Your Role as an IPI Advisor
- Reasons MDH Would Do All or Part of a Visit
- Chapter 3
- Future follow-up
- Conducting the Visit
- Preparing for the Visit
- Information for the Visit
- Site Visit Checklist
- Scheduling the Visit
- Chapter 4
- After the Site Visit
- MnVFC Provider Follow-up Plan
- MnVFC Site Visit Storage and Handling Per Unit Answer Sheet
- Section 6 Inventory
- Section 5 Storage amp Handling Site-Wide
- Section 4 Storage amp Handling Per Unit
- Section 3 Documentation
- Section 2 Eligibility
- Section 1 Provider Details
- The Site Visit Reviewer Legend
- MnVFC Site Visit Questionnaire
- Required Paperwork for Site Visits
- Chapter 5
-
IPI Advisor Manual | February 2017 Page 47
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
Question 626 Inventory ACIP Recommended Vaccines
Question 62 Review providerrsquos current inventory to answer the questions below
A Does the provider offer all routine ACIP-recommendedvaccines for their patient population
Yes (Skip to question C) No [X] Offers all except varicella because direct ship ofvaccine is unavailable from manufacturer
B Which routine vaccines are NOT being offered DTaP Hepatitis A Hepatitis B HIB HPV Influenza Meningococcal
MMR Pneumococcal Polio Rotavirus TdapTd Varicella
C According to Immunization Program Policy does theprovider make accessible all non-routine ACIP-recommended vaccines for those VFC patients whomeet the criteria for receiving them
Yes (Skip to question 63) No [X]
D Which non-routine vaccines are NOT being offered Pneumococcal polysaccharide vaccine (PPSV23) Meningococcal Group B (MenB) Other
Review CDC Requirement
VFC providers agree to comply with immunization schedules dosages and contraindications that are established by the Advisory Committee on Immunization Practices (ACIP) for the vaccines identified and agreed upon in the Provider Agreement UNLESS bull In the VFC providers medical judgment and in accordance with accepted medical practice the VFC provider deems such
compliance to be medically inappropriate for the child bull The particular requirements contradict state law including laws pertaining to religious and other exemptions The VFC program entitles children to the following vaccines DTaP Hepatitis A Hepatitis B HIB HPV Influenza MeningococcalMMR Pneumococcal Polio Rotavirus TdapTd and Varicella VFC providers are also required to ensure that VFC-eligible children have access to non-routine vaccines as needed
Goal of this question Assess if the site is offering all the ACIP-recommended vaccines for the population they serve and these vaccines are in stock on the day of the visit It is important that every MnVFC-eligible child that comes to a providerrsquos office for an immunization is vaccinated
Helpful information bull The Advisory Committee on Immunization Practices (ACIP) is a group of medical and public health experts that develops recommendations on how to use vaccines to control diseases in the United States
bull Specialty providers are not required to offer all routine vaccines but should provide the vaccines appropriate for their population
bull If the site does not offer all routine ACIP-recommended vaccines appropriate for their population check the ldquoNordquo box in Part A then check the appropriate box(es) in Part B for any vaccines not offered Please contact MDH as this situation offers us the opportunity to provide education to the site
bull For non-routine vaccines they must either be in stock or the site must have an alternative protocol in the routine management plan that ensures these children have access when applicable
Resources bull IAC Diseases and Vaccines (wwwimmunizeorgvaccines) bull CDC Advisory Committee on Immunization Practices (ACIP) (wwwcdcgovvaccinesacipindexhtml)
Page 48 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 636 Inventory Separation of Stock
Question 63 Observe how the provider differentiates stock in each storage unit to answer the questions below
A Is it clear which vaccines belong to public stock andwhich belong to private stock
Yes No [X] Not applicable replacement site
B Is it clear which vaccines belong to VFC stock andwhich belong to UUAV stock
Yes No [X] Not applicable replacement site Not applicable not UUAV-enrolled site
Review CDC Requirement
In order to ensure that VFC vaccines are only administered to VFC-eligible children VFC providers that serve both VFC and non-VFCshyeligible children must maintain their vaccine inventories in such a way that they can clearly differentiate public stock from privatestock as well as VFC from other public stock
Goal of this question Assess whether the site can distinguish between MnVFC vaccine and private vaccine If they participate in the Uninsured and Underinsured Adult Vaccine (UUAV) program they should also be able to distinguish between MnVFC stock and UUAV stock Some sites use labels bins boxes etc to differentiate their stock If it is not clear how the site differentiates their stock discuss vaccine management with the staff For follow-up call MDH to discuss doing a follow-up site visit
Sites using the replacement method will not have separate stocksmdashthis is an approved alternative method for keeping track of vaccine
Resource bull Section 10 of the MnVFC Policy and Procedure Manual
IPI Advisor Manual | February 2017 Page 49
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
MnVFC Site Visit Storage and Handling Per Unit Answer Sheet 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet MnVFC PIN ___________________
Question number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
Temperature Monitoring Device Questions Questions 43 47 must be answered separately for the freezer and refrigerator if the unit is a combo Be sure to document responses in the appropriate column
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
All the questions on the Site Visit Storage amp Handling Per Unit Answer Sheet have been discussed previously in section 4 of this manual Use this sheet to record information about all the units at the site visit You will need one sheet for each unit If it is a combination unit (either pharmaceutical or household) you can record both sections on one sheet If they have stand-alone units use one sheet for each unit Do not enter the answers to the questions in section 4 of the questionnaire
If you need more information about any of the questions refer back to the main questionnairemdashthe complete question additional guidance including notes to the reviewer and the CDC requirements are there Also if the site is not meeting the requirement you will go back to the questionnaire to complete the ldquoActions if Non-compliantrdquo section including the root cause analysis and follow-up sections
When you have completed the assessment of all the storage units remember to go back to the questionnaire to complete sections 5 and 6
Page 50 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
ndash
ndash
MnVFC Provider Follow-up PlanThe goal of the Provider Follow-up Plan is to communicate with the site all of the VFC requirements any unmet requirements found during your site visit and the timeline for completing the required action The left hand column is a box to check for ldquoUnmetrdquo requirements
Helpful information bull The form can be used to review what the site is doing well and what they need to work on
bull For requirements that have specific documentation that needs to be sent to you use the notes section
2017 MnVFC Provider Follow-up Plan Site _______________________________________________ MnVFC PIN ____________ Date of Visit ___________
Thank you for participating in this MnVFC compliance site visit Please review this visit summary including follow-up actions and timelines for completion Unmet MnVFC requirements and recommendations have a checked box next to them The goal of this plan is to support you with successfully implementing the program and improving access to vaccines for VFC-eligible children
Unmet Question VFC Requirements Section 1 Changes to Key Staff
Q12 Change in the Medical Director Immunization Manager Vaccine Coordinator or back-upKey Staff must be communicated to the immunization program by emailing healthmnvfcstatemnus Changes Notes
Q12 Key staff must complete the annual training on VFC program requirements and print theAnnual Training certificate of completion Documentation Required Action
Staff that have not completed the MnVFC online training must complete it and send acopy of the certificate to the reviewer Training can be found on the MnVFC website (wwwhealthstatemnusvfc) Due date 1 month
Notes
Unmet Question VFC Requirements Section 2 Eligibility
Q21 Provider staff must possess a working knowledge of all VFC eligibility criteria and use thoseVFC Eligibility criteria to screen children prior to administering VFC vaccines
Categories Notes
bull This form provides documentation needed for follow-up actions when you send your thank you email
The second to last page of the Provider Follow-up Plan has a summary of the MnVFC program recommendations These are to remind the site about best practices they may want to improve upon even though they are not yet requirements of the program For example you could discuss the recommendation about storage units if they currently have a combination household unit and are using both sections
The last section is for your signature and the person you met with In most sites it will be the immunization manager or vaccine coordinator who signs the form unless the medical director attended the site visit You keep the original copy and the site will need to keep a copy for themselves
To be completed by the site visit reviewer
I acknowledge that a VFC site visit was performed on __________________ (visit date) The follow-up plan which includes a list of all current VFC program requirements and recommendations assessed during the visit and any required follow-up actions was provided at the end of the visit
Site visit reviewer
Phone
Reviewer Signature Date
To be completed by the provider
I acknowledge that our practice took part in the VFC site visit noted above I understand the findings of the visit and any required actions that must be taken by our office in order to meet VFC program requirements
Medical Director (or designee) Name Title
Medical Director (or designee) Signature Date
IPI Advisor Manual | February 2017 Page 51
The 2017 MnVFC Site Visit Paperwork Chapter 4
After the Site Visit Send a thank you email highlighting the unmet requirements documents you need from the site to resolve the issue(s) and the date you need them Make sure to include the link to the Site Visit Survey (httpssurveyvovicicomseashxs=56206EE334CE0B14)
Please refer to Chapter 3 for more information about future follow-up required after the visit including forms and documentation
Resource bull Sample Thank You letter on IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml)
Chapter 5
IPI Advisor Resource List MnVFC Program 651-201-5522
MnVFC wwwhealthstatemnusvfc
bull Separate Stock and Replacement Method Policies and Procedures Manuals bull Online trainings bull MnVFC Announcements sign up to receive them via email bull Ordering MDH vaccine bull MnVFC forms Screening forms Reporting forms Others MDH Nonviable Vaccine Form MDH Vaccine Transfer Record and Vaccine Borrowing Report
bull MnVFC promotional materials bull Immunization Billing Guidance for MnVFC and Immunization Billing Guidance for MnVFC Replacement Sites Immunization Practices Improvement Program (IPI) wwwhealthstatemnusdivsidepcimmunizeipi
bull IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml) bull IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml) IPI Resource Folder Contents (wwwhealthstatemnusdivsidepcimmunizeipiipifolderpdf)
Minnesota Immunization Information Connection (MIIC) wwwhealthstatemnusmiic
bull MIIC regions and regional coordinators
Clinical Practice MDH Immunization Program wwwhealthstatemnusimmunize
Got Your Shots News wwwhealthstatemnusdivsidepcnewslettersgys
MDH Immunization Information for Health Care Providers wwwhealthstatemnusdivsidepcimmunizehcp
bull Got Your Shots A Providers Guide to Immunization in Minnesota bull Vaccine protocols bull Forms for tracking patient immunizations bull Immunization schedules for Health Care Providers Immunization Action Coalition (IAC) wwwimmunizeorg
bull Ask the Experts bull VISs (Vaccine Information Statements and translations) bull Administration screening questions bull Medical management of vaccine reactions bull Order form for Californiarsquos Immunization Technique DVD Best Practices with Infants Children and Adults
Page 52 IPI Advisor Manual| February 2017
IPI Advisor Resource List Chapter 5
CDC ldquoPink Bookrdquo wwwcdcgovvaccinespubspinkbookindexhtml
CDC Advisory Committee on Immunization Practices (ACIP) wwwcdcgovvaccinesacip
CDC Vaccines and Immunizations wwwcdcgovvaccines
VAERS reporting httpvaershhsgovindex
Storage and Handling Got Your Shots Providers Guide ndash Managing Vaccine wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml
MnVFC Guide to Temperature Monitoring Devices wwwhealthstatemnusvfc
MDH Clinicianrsquos Vaccine Mishap Checklist wwwhealthstatemnusdivsidepcimmunizeipivaxchklstpdf
MDH Vaccine Storage Guide wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml
CDC Vaccine Storage and Handling Toolkit wwwcdcgovvaccinesrecsstoragetoolkit
You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Vaccine manufacturer phone numbers wwwcdcgovvaccinespubspinkbookdownloadsappendicesFcontact-info-manufactpdf
IAC Checklist for Safe Vaccine Handling and Storage wwwimmunizeorgcatgdp3035pdf
IAC Donrsquot Be Guilty of These Errors in Vaccine Storage and Handling wwwimmunizeorgcatgdp3036pdf
Additional Resources Print materials from MDH ndash order forms wwwhealthstatemnusdivsidepcimmunizeordermathtml
Vaccine Education Center ndash Childrenrsquos Hospital of Philadelphia wwwchopeduservicevaccine-education-centerhomehtml
California Department of Public Health ndash Interactive training on vaccine administration and storage and handling handout on transporting vaccine and how to package wwwezizorg
IPI Advisor Manual | February 2017 Page 53
IPI Advisor Resource List Chapter 5
CDC vaccine price list wwwcdcgovvaccinesprogramsvfcawardeesvaccine-managementprice-listindexhtml
Vaccine Information Statements (VIS) wwwcdcgovvaccineshcpvisindexhtml
CEU Opportunities CDC Immunization Education and Training wwwcdcgovvaccinesedindexhtml
Immunization You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Page 54 IPI Advisor Manual| February 2017
- Introduction
-
- Welcome to the Immunization Practice Improvement (IPI) Program
- Contact Information
-
- Chapter 1
- Requirements to Participate in the MnVFC Program
- Vaccines for Children Program
- Chapter 2
- Reimbursement for MnVFC Visits
- Types of Visits
- Your MnVFC Clinical CoordinatorPlanner
- New IPI Advisor Training Requirements
- Your Role as an IPI Advisor
- Reasons MDH Would Do All or Part of a Visit
- Chapter 3
- Future follow-up
- Conducting the Visit
- Preparing for the Visit
- Information for the Visit
- Site Visit Checklist
- Scheduling the Visit
- Chapter 4
- After the Site Visit
- MnVFC Provider Follow-up Plan
- MnVFC Site Visit Storage and Handling Per Unit Answer Sheet
- Section 6 Inventory
- Section 5 Storage amp Handling Site-Wide
- Section 4 Storage amp Handling Per Unit
- Section 3 Documentation
- Section 2 Eligibility
- Section 1 Provider Details
- The Site Visit Reviewer Legend
- MnVFC Site Visit Questionnaire
- Required Paperwork for Site Visits
- Chapter 5
-
Page 48 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
Question 636 Inventory Separation of Stock
Question 63 Observe how the provider differentiates stock in each storage unit to answer the questions below
A Is it clear which vaccines belong to public stock andwhich belong to private stock
Yes No [X] Not applicable replacement site
B Is it clear which vaccines belong to VFC stock andwhich belong to UUAV stock
Yes No [X] Not applicable replacement site Not applicable not UUAV-enrolled site
Review CDC Requirement
In order to ensure that VFC vaccines are only administered to VFC-eligible children VFC providers that serve both VFC and non-VFCshyeligible children must maintain their vaccine inventories in such a way that they can clearly differentiate public stock from privatestock as well as VFC from other public stock
Goal of this question Assess whether the site can distinguish between MnVFC vaccine and private vaccine If they participate in the Uninsured and Underinsured Adult Vaccine (UUAV) program they should also be able to distinguish between MnVFC stock and UUAV stock Some sites use labels bins boxes etc to differentiate their stock If it is not clear how the site differentiates their stock discuss vaccine management with the staff For follow-up call MDH to discuss doing a follow-up site visit
Sites using the replacement method will not have separate stocksmdashthis is an approved alternative method for keeping track of vaccine
Resource bull Section 10 of the MnVFC Policy and Procedure Manual
IPI Advisor Manual | February 2017 Page 49
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
MnVFC Site Visit Storage and Handling Per Unit Answer Sheet 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet MnVFC PIN ___________________
Question number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
Temperature Monitoring Device Questions Questions 43 47 must be answered separately for the freezer and refrigerator if the unit is a combo Be sure to document responses in the appropriate column
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
All the questions on the Site Visit Storage amp Handling Per Unit Answer Sheet have been discussed previously in section 4 of this manual Use this sheet to record information about all the units at the site visit You will need one sheet for each unit If it is a combination unit (either pharmaceutical or household) you can record both sections on one sheet If they have stand-alone units use one sheet for each unit Do not enter the answers to the questions in section 4 of the questionnaire
If you need more information about any of the questions refer back to the main questionnairemdashthe complete question additional guidance including notes to the reviewer and the CDC requirements are there Also if the site is not meeting the requirement you will go back to the questionnaire to complete the ldquoActions if Non-compliantrdquo section including the root cause analysis and follow-up sections
When you have completed the assessment of all the storage units remember to go back to the questionnaire to complete sections 5 and 6
Page 50 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
ndash
ndash
MnVFC Provider Follow-up PlanThe goal of the Provider Follow-up Plan is to communicate with the site all of the VFC requirements any unmet requirements found during your site visit and the timeline for completing the required action The left hand column is a box to check for ldquoUnmetrdquo requirements
Helpful information bull The form can be used to review what the site is doing well and what they need to work on
bull For requirements that have specific documentation that needs to be sent to you use the notes section
2017 MnVFC Provider Follow-up Plan Site _______________________________________________ MnVFC PIN ____________ Date of Visit ___________
Thank you for participating in this MnVFC compliance site visit Please review this visit summary including follow-up actions and timelines for completion Unmet MnVFC requirements and recommendations have a checked box next to them The goal of this plan is to support you with successfully implementing the program and improving access to vaccines for VFC-eligible children
Unmet Question VFC Requirements Section 1 Changes to Key Staff
Q12 Change in the Medical Director Immunization Manager Vaccine Coordinator or back-upKey Staff must be communicated to the immunization program by emailing healthmnvfcstatemnus Changes Notes
Q12 Key staff must complete the annual training on VFC program requirements and print theAnnual Training certificate of completion Documentation Required Action
Staff that have not completed the MnVFC online training must complete it and send acopy of the certificate to the reviewer Training can be found on the MnVFC website (wwwhealthstatemnusvfc) Due date 1 month
Notes
Unmet Question VFC Requirements Section 2 Eligibility
Q21 Provider staff must possess a working knowledge of all VFC eligibility criteria and use thoseVFC Eligibility criteria to screen children prior to administering VFC vaccines
Categories Notes
bull This form provides documentation needed for follow-up actions when you send your thank you email
The second to last page of the Provider Follow-up Plan has a summary of the MnVFC program recommendations These are to remind the site about best practices they may want to improve upon even though they are not yet requirements of the program For example you could discuss the recommendation about storage units if they currently have a combination household unit and are using both sections
The last section is for your signature and the person you met with In most sites it will be the immunization manager or vaccine coordinator who signs the form unless the medical director attended the site visit You keep the original copy and the site will need to keep a copy for themselves
To be completed by the site visit reviewer
I acknowledge that a VFC site visit was performed on __________________ (visit date) The follow-up plan which includes a list of all current VFC program requirements and recommendations assessed during the visit and any required follow-up actions was provided at the end of the visit
Site visit reviewer
Phone
Reviewer Signature Date
To be completed by the provider
I acknowledge that our practice took part in the VFC site visit noted above I understand the findings of the visit and any required actions that must be taken by our office in order to meet VFC program requirements
Medical Director (or designee) Name Title
Medical Director (or designee) Signature Date
IPI Advisor Manual | February 2017 Page 51
The 2017 MnVFC Site Visit Paperwork Chapter 4
After the Site Visit Send a thank you email highlighting the unmet requirements documents you need from the site to resolve the issue(s) and the date you need them Make sure to include the link to the Site Visit Survey (httpssurveyvovicicomseashxs=56206EE334CE0B14)
Please refer to Chapter 3 for more information about future follow-up required after the visit including forms and documentation
Resource bull Sample Thank You letter on IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml)
Chapter 5
IPI Advisor Resource List MnVFC Program 651-201-5522
MnVFC wwwhealthstatemnusvfc
bull Separate Stock and Replacement Method Policies and Procedures Manuals bull Online trainings bull MnVFC Announcements sign up to receive them via email bull Ordering MDH vaccine bull MnVFC forms Screening forms Reporting forms Others MDH Nonviable Vaccine Form MDH Vaccine Transfer Record and Vaccine Borrowing Report
bull MnVFC promotional materials bull Immunization Billing Guidance for MnVFC and Immunization Billing Guidance for MnVFC Replacement Sites Immunization Practices Improvement Program (IPI) wwwhealthstatemnusdivsidepcimmunizeipi
bull IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml) bull IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml) IPI Resource Folder Contents (wwwhealthstatemnusdivsidepcimmunizeipiipifolderpdf)
Minnesota Immunization Information Connection (MIIC) wwwhealthstatemnusmiic
bull MIIC regions and regional coordinators
Clinical Practice MDH Immunization Program wwwhealthstatemnusimmunize
Got Your Shots News wwwhealthstatemnusdivsidepcnewslettersgys
MDH Immunization Information for Health Care Providers wwwhealthstatemnusdivsidepcimmunizehcp
bull Got Your Shots A Providers Guide to Immunization in Minnesota bull Vaccine protocols bull Forms for tracking patient immunizations bull Immunization schedules for Health Care Providers Immunization Action Coalition (IAC) wwwimmunizeorg
bull Ask the Experts bull VISs (Vaccine Information Statements and translations) bull Administration screening questions bull Medical management of vaccine reactions bull Order form for Californiarsquos Immunization Technique DVD Best Practices with Infants Children and Adults
Page 52 IPI Advisor Manual| February 2017
IPI Advisor Resource List Chapter 5
CDC ldquoPink Bookrdquo wwwcdcgovvaccinespubspinkbookindexhtml
CDC Advisory Committee on Immunization Practices (ACIP) wwwcdcgovvaccinesacip
CDC Vaccines and Immunizations wwwcdcgovvaccines
VAERS reporting httpvaershhsgovindex
Storage and Handling Got Your Shots Providers Guide ndash Managing Vaccine wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml
MnVFC Guide to Temperature Monitoring Devices wwwhealthstatemnusvfc
MDH Clinicianrsquos Vaccine Mishap Checklist wwwhealthstatemnusdivsidepcimmunizeipivaxchklstpdf
MDH Vaccine Storage Guide wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml
CDC Vaccine Storage and Handling Toolkit wwwcdcgovvaccinesrecsstoragetoolkit
You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Vaccine manufacturer phone numbers wwwcdcgovvaccinespubspinkbookdownloadsappendicesFcontact-info-manufactpdf
IAC Checklist for Safe Vaccine Handling and Storage wwwimmunizeorgcatgdp3035pdf
IAC Donrsquot Be Guilty of These Errors in Vaccine Storage and Handling wwwimmunizeorgcatgdp3036pdf
Additional Resources Print materials from MDH ndash order forms wwwhealthstatemnusdivsidepcimmunizeordermathtml
Vaccine Education Center ndash Childrenrsquos Hospital of Philadelphia wwwchopeduservicevaccine-education-centerhomehtml
California Department of Public Health ndash Interactive training on vaccine administration and storage and handling handout on transporting vaccine and how to package wwwezizorg
IPI Advisor Manual | February 2017 Page 53
IPI Advisor Resource List Chapter 5
CDC vaccine price list wwwcdcgovvaccinesprogramsvfcawardeesvaccine-managementprice-listindexhtml
Vaccine Information Statements (VIS) wwwcdcgovvaccineshcpvisindexhtml
CEU Opportunities CDC Immunization Education and Training wwwcdcgovvaccinesedindexhtml
Immunization You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Page 54 IPI Advisor Manual| February 2017
- Introduction
-
- Welcome to the Immunization Practice Improvement (IPI) Program
- Contact Information
-
- Chapter 1
- Requirements to Participate in the MnVFC Program
- Vaccines for Children Program
- Chapter 2
- Reimbursement for MnVFC Visits
- Types of Visits
- Your MnVFC Clinical CoordinatorPlanner
- New IPI Advisor Training Requirements
- Your Role as an IPI Advisor
- Reasons MDH Would Do All or Part of a Visit
- Chapter 3
- Future follow-up
- Conducting the Visit
- Preparing for the Visit
- Information for the Visit
- Site Visit Checklist
- Scheduling the Visit
- Chapter 4
- After the Site Visit
- MnVFC Provider Follow-up Plan
- MnVFC Site Visit Storage and Handling Per Unit Answer Sheet
- Section 6 Inventory
- Section 5 Storage amp Handling Site-Wide
- Section 4 Storage amp Handling Per Unit
- Section 3 Documentation
- Section 2 Eligibility
- Section 1 Provider Details
- The Site Visit Reviewer Legend
- MnVFC Site Visit Questionnaire
- Required Paperwork for Site Visits
- Chapter 5
-
IPI Advisor Manual | February 2017 Page 49
The 2017 MnVFC Site Visit Paperwork Chapter 4
-
MnVFC Site Visit Storage and Handling Per Unit Answer Sheet 2017 MnVFC Site Visit Storage amp Handling Per Unit Answer Sheet MnVFC PIN ___________________
Question number and content area
Unit description ndash Brand Location
41A Type of unit Stand-alone Combination
41B Use if stand-alone Refrigerator Freezer
41B Use if combination Both sections Refrigerator only Freezer only
42 Select grade Pharmaceutical Commercialhousehold [O] CDC does not recommend using both sections of household units
Temperature Monitoring Device Questions Questions 43 47 must be answered separately for the freezer and refrigerator if the unit is a combo Be sure to document responses in the appropriate column
Storage unit section Refrigerator Freezer
43A Temperature monitoring device Yes No [X] (if no skip to 47)
Yes No [X] (if no skip to 47)
44A Continuous monitoring and recording device
Yes No [O] (if no skip D)
Yes No [O] (if no skip D)
44B Have a probe in buffered material
Yes No [O]
Yes No [O]
44C Digital display that can be read from outside the unit
Yes No [O]
Yes No [O]
All the questions on the Site Visit Storage amp Handling Per Unit Answer Sheet have been discussed previously in section 4 of this manual Use this sheet to record information about all the units at the site visit You will need one sheet for each unit If it is a combination unit (either pharmaceutical or household) you can record both sections on one sheet If they have stand-alone units use one sheet for each unit Do not enter the answers to the questions in section 4 of the questionnaire
If you need more information about any of the questions refer back to the main questionnairemdashthe complete question additional guidance including notes to the reviewer and the CDC requirements are there Also if the site is not meeting the requirement you will go back to the questionnaire to complete the ldquoActions if Non-compliantrdquo section including the root cause analysis and follow-up sections
When you have completed the assessment of all the storage units remember to go back to the questionnaire to complete sections 5 and 6
Page 50 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
ndash
ndash
MnVFC Provider Follow-up PlanThe goal of the Provider Follow-up Plan is to communicate with the site all of the VFC requirements any unmet requirements found during your site visit and the timeline for completing the required action The left hand column is a box to check for ldquoUnmetrdquo requirements
Helpful information bull The form can be used to review what the site is doing well and what they need to work on
bull For requirements that have specific documentation that needs to be sent to you use the notes section
2017 MnVFC Provider Follow-up Plan Site _______________________________________________ MnVFC PIN ____________ Date of Visit ___________
Thank you for participating in this MnVFC compliance site visit Please review this visit summary including follow-up actions and timelines for completion Unmet MnVFC requirements and recommendations have a checked box next to them The goal of this plan is to support you with successfully implementing the program and improving access to vaccines for VFC-eligible children
Unmet Question VFC Requirements Section 1 Changes to Key Staff
Q12 Change in the Medical Director Immunization Manager Vaccine Coordinator or back-upKey Staff must be communicated to the immunization program by emailing healthmnvfcstatemnus Changes Notes
Q12 Key staff must complete the annual training on VFC program requirements and print theAnnual Training certificate of completion Documentation Required Action
Staff that have not completed the MnVFC online training must complete it and send acopy of the certificate to the reviewer Training can be found on the MnVFC website (wwwhealthstatemnusvfc) Due date 1 month
Notes
Unmet Question VFC Requirements Section 2 Eligibility
Q21 Provider staff must possess a working knowledge of all VFC eligibility criteria and use thoseVFC Eligibility criteria to screen children prior to administering VFC vaccines
Categories Notes
bull This form provides documentation needed for follow-up actions when you send your thank you email
The second to last page of the Provider Follow-up Plan has a summary of the MnVFC program recommendations These are to remind the site about best practices they may want to improve upon even though they are not yet requirements of the program For example you could discuss the recommendation about storage units if they currently have a combination household unit and are using both sections
The last section is for your signature and the person you met with In most sites it will be the immunization manager or vaccine coordinator who signs the form unless the medical director attended the site visit You keep the original copy and the site will need to keep a copy for themselves
To be completed by the site visit reviewer
I acknowledge that a VFC site visit was performed on __________________ (visit date) The follow-up plan which includes a list of all current VFC program requirements and recommendations assessed during the visit and any required follow-up actions was provided at the end of the visit
Site visit reviewer
Phone
Reviewer Signature Date
To be completed by the provider
I acknowledge that our practice took part in the VFC site visit noted above I understand the findings of the visit and any required actions that must be taken by our office in order to meet VFC program requirements
Medical Director (or designee) Name Title
Medical Director (or designee) Signature Date
IPI Advisor Manual | February 2017 Page 51
The 2017 MnVFC Site Visit Paperwork Chapter 4
After the Site Visit Send a thank you email highlighting the unmet requirements documents you need from the site to resolve the issue(s) and the date you need them Make sure to include the link to the Site Visit Survey (httpssurveyvovicicomseashxs=56206EE334CE0B14)
Please refer to Chapter 3 for more information about future follow-up required after the visit including forms and documentation
Resource bull Sample Thank You letter on IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml)
Chapter 5
IPI Advisor Resource List MnVFC Program 651-201-5522
MnVFC wwwhealthstatemnusvfc
bull Separate Stock and Replacement Method Policies and Procedures Manuals bull Online trainings bull MnVFC Announcements sign up to receive them via email bull Ordering MDH vaccine bull MnVFC forms Screening forms Reporting forms Others MDH Nonviable Vaccine Form MDH Vaccine Transfer Record and Vaccine Borrowing Report
bull MnVFC promotional materials bull Immunization Billing Guidance for MnVFC and Immunization Billing Guidance for MnVFC Replacement Sites Immunization Practices Improvement Program (IPI) wwwhealthstatemnusdivsidepcimmunizeipi
bull IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml) bull IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml) IPI Resource Folder Contents (wwwhealthstatemnusdivsidepcimmunizeipiipifolderpdf)
Minnesota Immunization Information Connection (MIIC) wwwhealthstatemnusmiic
bull MIIC regions and regional coordinators
Clinical Practice MDH Immunization Program wwwhealthstatemnusimmunize
Got Your Shots News wwwhealthstatemnusdivsidepcnewslettersgys
MDH Immunization Information for Health Care Providers wwwhealthstatemnusdivsidepcimmunizehcp
bull Got Your Shots A Providers Guide to Immunization in Minnesota bull Vaccine protocols bull Forms for tracking patient immunizations bull Immunization schedules for Health Care Providers Immunization Action Coalition (IAC) wwwimmunizeorg
bull Ask the Experts bull VISs (Vaccine Information Statements and translations) bull Administration screening questions bull Medical management of vaccine reactions bull Order form for Californiarsquos Immunization Technique DVD Best Practices with Infants Children and Adults
Page 52 IPI Advisor Manual| February 2017
IPI Advisor Resource List Chapter 5
CDC ldquoPink Bookrdquo wwwcdcgovvaccinespubspinkbookindexhtml
CDC Advisory Committee on Immunization Practices (ACIP) wwwcdcgovvaccinesacip
CDC Vaccines and Immunizations wwwcdcgovvaccines
VAERS reporting httpvaershhsgovindex
Storage and Handling Got Your Shots Providers Guide ndash Managing Vaccine wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml
MnVFC Guide to Temperature Monitoring Devices wwwhealthstatemnusvfc
MDH Clinicianrsquos Vaccine Mishap Checklist wwwhealthstatemnusdivsidepcimmunizeipivaxchklstpdf
MDH Vaccine Storage Guide wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml
CDC Vaccine Storage and Handling Toolkit wwwcdcgovvaccinesrecsstoragetoolkit
You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Vaccine manufacturer phone numbers wwwcdcgovvaccinespubspinkbookdownloadsappendicesFcontact-info-manufactpdf
IAC Checklist for Safe Vaccine Handling and Storage wwwimmunizeorgcatgdp3035pdf
IAC Donrsquot Be Guilty of These Errors in Vaccine Storage and Handling wwwimmunizeorgcatgdp3036pdf
Additional Resources Print materials from MDH ndash order forms wwwhealthstatemnusdivsidepcimmunizeordermathtml
Vaccine Education Center ndash Childrenrsquos Hospital of Philadelphia wwwchopeduservicevaccine-education-centerhomehtml
California Department of Public Health ndash Interactive training on vaccine administration and storage and handling handout on transporting vaccine and how to package wwwezizorg
IPI Advisor Manual | February 2017 Page 53
IPI Advisor Resource List Chapter 5
CDC vaccine price list wwwcdcgovvaccinesprogramsvfcawardeesvaccine-managementprice-listindexhtml
Vaccine Information Statements (VIS) wwwcdcgovvaccineshcpvisindexhtml
CEU Opportunities CDC Immunization Education and Training wwwcdcgovvaccinesedindexhtml
Immunization You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Page 54 IPI Advisor Manual| February 2017
- Introduction
-
- Welcome to the Immunization Practice Improvement (IPI) Program
- Contact Information
-
- Chapter 1
- Requirements to Participate in the MnVFC Program
- Vaccines for Children Program
- Chapter 2
- Reimbursement for MnVFC Visits
- Types of Visits
- Your MnVFC Clinical CoordinatorPlanner
- New IPI Advisor Training Requirements
- Your Role as an IPI Advisor
- Reasons MDH Would Do All or Part of a Visit
- Chapter 3
- Future follow-up
- Conducting the Visit
- Preparing for the Visit
- Information for the Visit
- Site Visit Checklist
- Scheduling the Visit
- Chapter 4
- After the Site Visit
- MnVFC Provider Follow-up Plan
- MnVFC Site Visit Storage and Handling Per Unit Answer Sheet
- Section 6 Inventory
- Section 5 Storage amp Handling Site-Wide
- Section 4 Storage amp Handling Per Unit
- Section 3 Documentation
- Section 2 Eligibility
- Section 1 Provider Details
- The Site Visit Reviewer Legend
- MnVFC Site Visit Questionnaire
- Required Paperwork for Site Visits
- Chapter 5
-
Page 50 IPI Advisor Manual | February 2017
The 2017 MnVFC Site Visit Paperwork Chapter 4
ndash
ndash
MnVFC Provider Follow-up PlanThe goal of the Provider Follow-up Plan is to communicate with the site all of the VFC requirements any unmet requirements found during your site visit and the timeline for completing the required action The left hand column is a box to check for ldquoUnmetrdquo requirements
Helpful information bull The form can be used to review what the site is doing well and what they need to work on
bull For requirements that have specific documentation that needs to be sent to you use the notes section
2017 MnVFC Provider Follow-up Plan Site _______________________________________________ MnVFC PIN ____________ Date of Visit ___________
Thank you for participating in this MnVFC compliance site visit Please review this visit summary including follow-up actions and timelines for completion Unmet MnVFC requirements and recommendations have a checked box next to them The goal of this plan is to support you with successfully implementing the program and improving access to vaccines for VFC-eligible children
Unmet Question VFC Requirements Section 1 Changes to Key Staff
Q12 Change in the Medical Director Immunization Manager Vaccine Coordinator or back-upKey Staff must be communicated to the immunization program by emailing healthmnvfcstatemnus Changes Notes
Q12 Key staff must complete the annual training on VFC program requirements and print theAnnual Training certificate of completion Documentation Required Action
Staff that have not completed the MnVFC online training must complete it and send acopy of the certificate to the reviewer Training can be found on the MnVFC website (wwwhealthstatemnusvfc) Due date 1 month
Notes
Unmet Question VFC Requirements Section 2 Eligibility
Q21 Provider staff must possess a working knowledge of all VFC eligibility criteria and use thoseVFC Eligibility criteria to screen children prior to administering VFC vaccines
Categories Notes
bull This form provides documentation needed for follow-up actions when you send your thank you email
The second to last page of the Provider Follow-up Plan has a summary of the MnVFC program recommendations These are to remind the site about best practices they may want to improve upon even though they are not yet requirements of the program For example you could discuss the recommendation about storage units if they currently have a combination household unit and are using both sections
The last section is for your signature and the person you met with In most sites it will be the immunization manager or vaccine coordinator who signs the form unless the medical director attended the site visit You keep the original copy and the site will need to keep a copy for themselves
To be completed by the site visit reviewer
I acknowledge that a VFC site visit was performed on __________________ (visit date) The follow-up plan which includes a list of all current VFC program requirements and recommendations assessed during the visit and any required follow-up actions was provided at the end of the visit
Site visit reviewer
Phone
Reviewer Signature Date
To be completed by the provider
I acknowledge that our practice took part in the VFC site visit noted above I understand the findings of the visit and any required actions that must be taken by our office in order to meet VFC program requirements
Medical Director (or designee) Name Title
Medical Director (or designee) Signature Date
IPI Advisor Manual | February 2017 Page 51
The 2017 MnVFC Site Visit Paperwork Chapter 4
After the Site Visit Send a thank you email highlighting the unmet requirements documents you need from the site to resolve the issue(s) and the date you need them Make sure to include the link to the Site Visit Survey (httpssurveyvovicicomseashxs=56206EE334CE0B14)
Please refer to Chapter 3 for more information about future follow-up required after the visit including forms and documentation
Resource bull Sample Thank You letter on IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml)
Chapter 5
IPI Advisor Resource List MnVFC Program 651-201-5522
MnVFC wwwhealthstatemnusvfc
bull Separate Stock and Replacement Method Policies and Procedures Manuals bull Online trainings bull MnVFC Announcements sign up to receive them via email bull Ordering MDH vaccine bull MnVFC forms Screening forms Reporting forms Others MDH Nonviable Vaccine Form MDH Vaccine Transfer Record and Vaccine Borrowing Report
bull MnVFC promotional materials bull Immunization Billing Guidance for MnVFC and Immunization Billing Guidance for MnVFC Replacement Sites Immunization Practices Improvement Program (IPI) wwwhealthstatemnusdivsidepcimmunizeipi
bull IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml) bull IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml) IPI Resource Folder Contents (wwwhealthstatemnusdivsidepcimmunizeipiipifolderpdf)
Minnesota Immunization Information Connection (MIIC) wwwhealthstatemnusmiic
bull MIIC regions and regional coordinators
Clinical Practice MDH Immunization Program wwwhealthstatemnusimmunize
Got Your Shots News wwwhealthstatemnusdivsidepcnewslettersgys
MDH Immunization Information for Health Care Providers wwwhealthstatemnusdivsidepcimmunizehcp
bull Got Your Shots A Providers Guide to Immunization in Minnesota bull Vaccine protocols bull Forms for tracking patient immunizations bull Immunization schedules for Health Care Providers Immunization Action Coalition (IAC) wwwimmunizeorg
bull Ask the Experts bull VISs (Vaccine Information Statements and translations) bull Administration screening questions bull Medical management of vaccine reactions bull Order form for Californiarsquos Immunization Technique DVD Best Practices with Infants Children and Adults
Page 52 IPI Advisor Manual| February 2017
IPI Advisor Resource List Chapter 5
CDC ldquoPink Bookrdquo wwwcdcgovvaccinespubspinkbookindexhtml
CDC Advisory Committee on Immunization Practices (ACIP) wwwcdcgovvaccinesacip
CDC Vaccines and Immunizations wwwcdcgovvaccines
VAERS reporting httpvaershhsgovindex
Storage and Handling Got Your Shots Providers Guide ndash Managing Vaccine wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml
MnVFC Guide to Temperature Monitoring Devices wwwhealthstatemnusvfc
MDH Clinicianrsquos Vaccine Mishap Checklist wwwhealthstatemnusdivsidepcimmunizeipivaxchklstpdf
MDH Vaccine Storage Guide wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml
CDC Vaccine Storage and Handling Toolkit wwwcdcgovvaccinesrecsstoragetoolkit
You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Vaccine manufacturer phone numbers wwwcdcgovvaccinespubspinkbookdownloadsappendicesFcontact-info-manufactpdf
IAC Checklist for Safe Vaccine Handling and Storage wwwimmunizeorgcatgdp3035pdf
IAC Donrsquot Be Guilty of These Errors in Vaccine Storage and Handling wwwimmunizeorgcatgdp3036pdf
Additional Resources Print materials from MDH ndash order forms wwwhealthstatemnusdivsidepcimmunizeordermathtml
Vaccine Education Center ndash Childrenrsquos Hospital of Philadelphia wwwchopeduservicevaccine-education-centerhomehtml
California Department of Public Health ndash Interactive training on vaccine administration and storage and handling handout on transporting vaccine and how to package wwwezizorg
IPI Advisor Manual | February 2017 Page 53
IPI Advisor Resource List Chapter 5
CDC vaccine price list wwwcdcgovvaccinesprogramsvfcawardeesvaccine-managementprice-listindexhtml
Vaccine Information Statements (VIS) wwwcdcgovvaccineshcpvisindexhtml
CEU Opportunities CDC Immunization Education and Training wwwcdcgovvaccinesedindexhtml
Immunization You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Page 54 IPI Advisor Manual| February 2017
- Introduction
-
- Welcome to the Immunization Practice Improvement (IPI) Program
- Contact Information
-
- Chapter 1
- Requirements to Participate in the MnVFC Program
- Vaccines for Children Program
- Chapter 2
- Reimbursement for MnVFC Visits
- Types of Visits
- Your MnVFC Clinical CoordinatorPlanner
- New IPI Advisor Training Requirements
- Your Role as an IPI Advisor
- Reasons MDH Would Do All or Part of a Visit
- Chapter 3
- Future follow-up
- Conducting the Visit
- Preparing for the Visit
- Information for the Visit
- Site Visit Checklist
- Scheduling the Visit
- Chapter 4
- After the Site Visit
- MnVFC Provider Follow-up Plan
- MnVFC Site Visit Storage and Handling Per Unit Answer Sheet
- Section 6 Inventory
- Section 5 Storage amp Handling Site-Wide
- Section 4 Storage amp Handling Per Unit
- Section 3 Documentation
- Section 2 Eligibility
- Section 1 Provider Details
- The Site Visit Reviewer Legend
- MnVFC Site Visit Questionnaire
- Required Paperwork for Site Visits
- Chapter 5
-
IPI Advisor Manual | February 2017 Page 51
The 2017 MnVFC Site Visit Paperwork Chapter 4
After the Site Visit Send a thank you email highlighting the unmet requirements documents you need from the site to resolve the issue(s) and the date you need them Make sure to include the link to the Site Visit Survey (httpssurveyvovicicomseashxs=56206EE334CE0B14)
Please refer to Chapter 3 for more information about future follow-up required after the visit including forms and documentation
Resource bull Sample Thank You letter on IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml)
Chapter 5
IPI Advisor Resource List MnVFC Program 651-201-5522
MnVFC wwwhealthstatemnusvfc
bull Separate Stock and Replacement Method Policies and Procedures Manuals bull Online trainings bull MnVFC Announcements sign up to receive them via email bull Ordering MDH vaccine bull MnVFC forms Screening forms Reporting forms Others MDH Nonviable Vaccine Form MDH Vaccine Transfer Record and Vaccine Borrowing Report
bull MnVFC promotional materials bull Immunization Billing Guidance for MnVFC and Immunization Billing Guidance for MnVFC Replacement Sites Immunization Practices Improvement Program (IPI) wwwhealthstatemnusdivsidepcimmunizeipi
bull IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml) bull IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml) IPI Resource Folder Contents (wwwhealthstatemnusdivsidepcimmunizeipiipifolderpdf)
Minnesota Immunization Information Connection (MIIC) wwwhealthstatemnusmiic
bull MIIC regions and regional coordinators
Clinical Practice MDH Immunization Program wwwhealthstatemnusimmunize
Got Your Shots News wwwhealthstatemnusdivsidepcnewslettersgys
MDH Immunization Information for Health Care Providers wwwhealthstatemnusdivsidepcimmunizehcp
bull Got Your Shots A Providers Guide to Immunization in Minnesota bull Vaccine protocols bull Forms for tracking patient immunizations bull Immunization schedules for Health Care Providers Immunization Action Coalition (IAC) wwwimmunizeorg
bull Ask the Experts bull VISs (Vaccine Information Statements and translations) bull Administration screening questions bull Medical management of vaccine reactions bull Order form for Californiarsquos Immunization Technique DVD Best Practices with Infants Children and Adults
Page 52 IPI Advisor Manual| February 2017
IPI Advisor Resource List Chapter 5
CDC ldquoPink Bookrdquo wwwcdcgovvaccinespubspinkbookindexhtml
CDC Advisory Committee on Immunization Practices (ACIP) wwwcdcgovvaccinesacip
CDC Vaccines and Immunizations wwwcdcgovvaccines
VAERS reporting httpvaershhsgovindex
Storage and Handling Got Your Shots Providers Guide ndash Managing Vaccine wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml
MnVFC Guide to Temperature Monitoring Devices wwwhealthstatemnusvfc
MDH Clinicianrsquos Vaccine Mishap Checklist wwwhealthstatemnusdivsidepcimmunizeipivaxchklstpdf
MDH Vaccine Storage Guide wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml
CDC Vaccine Storage and Handling Toolkit wwwcdcgovvaccinesrecsstoragetoolkit
You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Vaccine manufacturer phone numbers wwwcdcgovvaccinespubspinkbookdownloadsappendicesFcontact-info-manufactpdf
IAC Checklist for Safe Vaccine Handling and Storage wwwimmunizeorgcatgdp3035pdf
IAC Donrsquot Be Guilty of These Errors in Vaccine Storage and Handling wwwimmunizeorgcatgdp3036pdf
Additional Resources Print materials from MDH ndash order forms wwwhealthstatemnusdivsidepcimmunizeordermathtml
Vaccine Education Center ndash Childrenrsquos Hospital of Philadelphia wwwchopeduservicevaccine-education-centerhomehtml
California Department of Public Health ndash Interactive training on vaccine administration and storage and handling handout on transporting vaccine and how to package wwwezizorg
IPI Advisor Manual | February 2017 Page 53
IPI Advisor Resource List Chapter 5
CDC vaccine price list wwwcdcgovvaccinesprogramsvfcawardeesvaccine-managementprice-listindexhtml
Vaccine Information Statements (VIS) wwwcdcgovvaccineshcpvisindexhtml
CEU Opportunities CDC Immunization Education and Training wwwcdcgovvaccinesedindexhtml
Immunization You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Page 54 IPI Advisor Manual| February 2017
- Introduction
-
- Welcome to the Immunization Practice Improvement (IPI) Program
- Contact Information
-
- Chapter 1
- Requirements to Participate in the MnVFC Program
- Vaccines for Children Program
- Chapter 2
- Reimbursement for MnVFC Visits
- Types of Visits
- Your MnVFC Clinical CoordinatorPlanner
- New IPI Advisor Training Requirements
- Your Role as an IPI Advisor
- Reasons MDH Would Do All or Part of a Visit
- Chapter 3
- Future follow-up
- Conducting the Visit
- Preparing for the Visit
- Information for the Visit
- Site Visit Checklist
- Scheduling the Visit
- Chapter 4
- After the Site Visit
- MnVFC Provider Follow-up Plan
- MnVFC Site Visit Storage and Handling Per Unit Answer Sheet
- Section 6 Inventory
- Section 5 Storage amp Handling Site-Wide
- Section 4 Storage amp Handling Per Unit
- Section 3 Documentation
- Section 2 Eligibility
- Section 1 Provider Details
- The Site Visit Reviewer Legend
- MnVFC Site Visit Questionnaire
- Required Paperwork for Site Visits
- Chapter 5
-
Chapter 5
IPI Advisor Resource List MnVFC Program 651-201-5522
MnVFC wwwhealthstatemnusvfc
bull Separate Stock and Replacement Method Policies and Procedures Manuals bull Online trainings bull MnVFC Announcements sign up to receive them via email bull Ordering MDH vaccine bull MnVFC forms Screening forms Reporting forms Others MDH Nonviable Vaccine Form MDH Vaccine Transfer Record and Vaccine Borrowing Report
bull MnVFC promotional materials bull Immunization Billing Guidance for MnVFC and Immunization Billing Guidance for MnVFC Replacement Sites Immunization Practices Improvement Program (IPI) wwwhealthstatemnusdivsidepcimmunizeipi
bull IPI Advisor Site Visit Materials (wwwhealthstatemnusdivsidepcimmunizeipisvmaterialshtml) bull IPI Program Resources (wwwhealthstatemnusdivsidepcimmunizeipiresourceshtml) IPI Resource Folder Contents (wwwhealthstatemnusdivsidepcimmunizeipiipifolderpdf)
Minnesota Immunization Information Connection (MIIC) wwwhealthstatemnusmiic
bull MIIC regions and regional coordinators
Clinical Practice MDH Immunization Program wwwhealthstatemnusimmunize
Got Your Shots News wwwhealthstatemnusdivsidepcnewslettersgys
MDH Immunization Information for Health Care Providers wwwhealthstatemnusdivsidepcimmunizehcp
bull Got Your Shots A Providers Guide to Immunization in Minnesota bull Vaccine protocols bull Forms for tracking patient immunizations bull Immunization schedules for Health Care Providers Immunization Action Coalition (IAC) wwwimmunizeorg
bull Ask the Experts bull VISs (Vaccine Information Statements and translations) bull Administration screening questions bull Medical management of vaccine reactions bull Order form for Californiarsquos Immunization Technique DVD Best Practices with Infants Children and Adults
Page 52 IPI Advisor Manual| February 2017
IPI Advisor Resource List Chapter 5
CDC ldquoPink Bookrdquo wwwcdcgovvaccinespubspinkbookindexhtml
CDC Advisory Committee on Immunization Practices (ACIP) wwwcdcgovvaccinesacip
CDC Vaccines and Immunizations wwwcdcgovvaccines
VAERS reporting httpvaershhsgovindex
Storage and Handling Got Your Shots Providers Guide ndash Managing Vaccine wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml
MnVFC Guide to Temperature Monitoring Devices wwwhealthstatemnusvfc
MDH Clinicianrsquos Vaccine Mishap Checklist wwwhealthstatemnusdivsidepcimmunizeipivaxchklstpdf
MDH Vaccine Storage Guide wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml
CDC Vaccine Storage and Handling Toolkit wwwcdcgovvaccinesrecsstoragetoolkit
You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Vaccine manufacturer phone numbers wwwcdcgovvaccinespubspinkbookdownloadsappendicesFcontact-info-manufactpdf
IAC Checklist for Safe Vaccine Handling and Storage wwwimmunizeorgcatgdp3035pdf
IAC Donrsquot Be Guilty of These Errors in Vaccine Storage and Handling wwwimmunizeorgcatgdp3036pdf
Additional Resources Print materials from MDH ndash order forms wwwhealthstatemnusdivsidepcimmunizeordermathtml
Vaccine Education Center ndash Childrenrsquos Hospital of Philadelphia wwwchopeduservicevaccine-education-centerhomehtml
California Department of Public Health ndash Interactive training on vaccine administration and storage and handling handout on transporting vaccine and how to package wwwezizorg
IPI Advisor Manual | February 2017 Page 53
IPI Advisor Resource List Chapter 5
CDC vaccine price list wwwcdcgovvaccinesprogramsvfcawardeesvaccine-managementprice-listindexhtml
Vaccine Information Statements (VIS) wwwcdcgovvaccineshcpvisindexhtml
CEU Opportunities CDC Immunization Education and Training wwwcdcgovvaccinesedindexhtml
Immunization You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Page 54 IPI Advisor Manual| February 2017
- Introduction
-
- Welcome to the Immunization Practice Improvement (IPI) Program
- Contact Information
-
- Chapter 1
- Requirements to Participate in the MnVFC Program
- Vaccines for Children Program
- Chapter 2
- Reimbursement for MnVFC Visits
- Types of Visits
- Your MnVFC Clinical CoordinatorPlanner
- New IPI Advisor Training Requirements
- Your Role as an IPI Advisor
- Reasons MDH Would Do All or Part of a Visit
- Chapter 3
- Future follow-up
- Conducting the Visit
- Preparing for the Visit
- Information for the Visit
- Site Visit Checklist
- Scheduling the Visit
- Chapter 4
- After the Site Visit
- MnVFC Provider Follow-up Plan
- MnVFC Site Visit Storage and Handling Per Unit Answer Sheet
- Section 6 Inventory
- Section 5 Storage amp Handling Site-Wide
- Section 4 Storage amp Handling Per Unit
- Section 3 Documentation
- Section 2 Eligibility
- Section 1 Provider Details
- The Site Visit Reviewer Legend
- MnVFC Site Visit Questionnaire
- Required Paperwork for Site Visits
- Chapter 5
-
IPI Advisor Resource List Chapter 5
CDC ldquoPink Bookrdquo wwwcdcgovvaccinespubspinkbookindexhtml
CDC Advisory Committee on Immunization Practices (ACIP) wwwcdcgovvaccinesacip
CDC Vaccines and Immunizations wwwcdcgovvaccines
VAERS reporting httpvaershhsgovindex
Storage and Handling Got Your Shots Providers Guide ndash Managing Vaccine wwwhealthstatemnusdivsidepcimmunizehcpprovguidemangvaxhtml
MnVFC Guide to Temperature Monitoring Devices wwwhealthstatemnusvfc
MDH Clinicianrsquos Vaccine Mishap Checklist wwwhealthstatemnusdivsidepcimmunizeipivaxchklstpdf
MDH Vaccine Storage Guide wwwhealthstatemnusdivsidepcimmunizehcpvaxhandlinghtml
CDC Vaccine Storage and Handling Toolkit wwwcdcgovvaccinesrecsstoragetoolkit
You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Vaccine manufacturer phone numbers wwwcdcgovvaccinespubspinkbookdownloadsappendicesFcontact-info-manufactpdf
IAC Checklist for Safe Vaccine Handling and Storage wwwimmunizeorgcatgdp3035pdf
IAC Donrsquot Be Guilty of These Errors in Vaccine Storage and Handling wwwimmunizeorgcatgdp3036pdf
Additional Resources Print materials from MDH ndash order forms wwwhealthstatemnusdivsidepcimmunizeordermathtml
Vaccine Education Center ndash Childrenrsquos Hospital of Philadelphia wwwchopeduservicevaccine-education-centerhomehtml
California Department of Public Health ndash Interactive training on vaccine administration and storage and handling handout on transporting vaccine and how to package wwwezizorg
IPI Advisor Manual | February 2017 Page 53
IPI Advisor Resource List Chapter 5
CDC vaccine price list wwwcdcgovvaccinesprogramsvfcawardeesvaccine-managementprice-listindexhtml
Vaccine Information Statements (VIS) wwwcdcgovvaccineshcpvisindexhtml
CEU Opportunities CDC Immunization Education and Training wwwcdcgovvaccinesedindexhtml
Immunization You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Page 54 IPI Advisor Manual| February 2017
- Introduction
-
- Welcome to the Immunization Practice Improvement (IPI) Program
- Contact Information
-
- Chapter 1
- Requirements to Participate in the MnVFC Program
- Vaccines for Children Program
- Chapter 2
- Reimbursement for MnVFC Visits
- Types of Visits
- Your MnVFC Clinical CoordinatorPlanner
- New IPI Advisor Training Requirements
- Your Role as an IPI Advisor
- Reasons MDH Would Do All or Part of a Visit
- Chapter 3
- Future follow-up
- Conducting the Visit
- Preparing for the Visit
- Information for the Visit
- Site Visit Checklist
- Scheduling the Visit
- Chapter 4
- After the Site Visit
- MnVFC Provider Follow-up Plan
- MnVFC Site Visit Storage and Handling Per Unit Answer Sheet
- Section 6 Inventory
- Section 5 Storage amp Handling Site-Wide
- Section 4 Storage amp Handling Per Unit
- Section 3 Documentation
- Section 2 Eligibility
- Section 1 Provider Details
- The Site Visit Reviewer Legend
- MnVFC Site Visit Questionnaire
- Required Paperwork for Site Visits
- Chapter 5
-
IPI Advisor Resource List Chapter 5
CDC vaccine price list wwwcdcgovvaccinesprogramsvfcawardeesvaccine-managementprice-listindexhtml
Vaccine Information Statements (VIS) wwwcdcgovvaccineshcpvisindexhtml
CEU Opportunities CDC Immunization Education and Training wwwcdcgovvaccinesedindexhtml
Immunization You Call the Shots wwwcdcgovvaccinesedyoucalltheshotshtml
Page 54 IPI Advisor Manual| February 2017
- Introduction
-
- Welcome to the Immunization Practice Improvement (IPI) Program
- Contact Information
-
- Chapter 1
- Requirements to Participate in the MnVFC Program
- Vaccines for Children Program
- Chapter 2
- Reimbursement for MnVFC Visits
- Types of Visits
- Your MnVFC Clinical CoordinatorPlanner
- New IPI Advisor Training Requirements
- Your Role as an IPI Advisor
- Reasons MDH Would Do All or Part of a Visit
- Chapter 3
- Future follow-up
- Conducting the Visit
- Preparing for the Visit
- Information for the Visit
- Site Visit Checklist
- Scheduling the Visit
- Chapter 4
- After the Site Visit
- MnVFC Provider Follow-up Plan
- MnVFC Site Visit Storage and Handling Per Unit Answer Sheet
- Section 6 Inventory
- Section 5 Storage amp Handling Site-Wide
- Section 4 Storage amp Handling Per Unit
- Section 3 Documentation
- Section 2 Eligibility
- Section 1 Provider Details
- The Site Visit Reviewer Legend
- MnVFC Site Visit Questionnaire
- Required Paperwork for Site Visits
- Chapter 5
-