interim upstate university hospital downtown campus ebola ... · 1/3/2017 · ii) evenings,...
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The information contained in this document was compiled and/or created as part of Quality assurance/Quality Improvement activities and/or peer review, and/or is patients safety work product, therefore, it is afforded all
available legal protections under State and Federal law, including, but not limited to, NYS Ed. Law § 6527 & Public Health Law § 2805-m, and the Patient Safety Quality Improvement Act. No redisclosure of the information is
allowed.
Interim Upstate University Hospital Downtown Campus
Ebola (EVD) Guidance
Revised: 1/3/2017
The goal of this document is to offer information during an encounter with a suspected EVD patient. It is not intended as an
all encompassing document but a collection of current guidance from other sources as well as existing policies and
procedures at Upstate.
Contents Background ................................................................................................................................................... 4 Transmission ................................................................................................................................................. 4 Case Definition ............................................................................................................................................. 4 Upstate EVD Notifications Listing: Downtown Campus ............................................................................. 4 Risk of Exposure (cdc.gov) ........................................................................................................................... 5 Personal Protective Equipment (PPE) ........................................................................................................... 6 Trained Observer Role Definition & Initial Training Guidance ...................................................................... 7
A Trained Observer primarily responsible for: .......................................................................................... 7 Use of a Trained Observer ........................................................................................................................ 7 Role Clarity ................................................................................................................................................ 7 S.T.E.P. practice ......................................................................................................................................... 8 Principles of PPE during an EVD Patient: .................................................................................................. 8 Donning: The Trained Observers Role in Donning .................................................................................... 9 Donning: Pre-Donning Briefing ................................................................................................................. 9 Donning: Error Catching and Pro-active Assistance ................................................................................ 10 Doffing: the Trained Observer’s Role in Doffing ..................................................................................... 10 Doffing: Role Clarity for Suit Buddy ........................................................................................................ 10 EVD PPE Roles & Training Matrix ........................................................................................................ 15 EVD PPE “on-hand” Matrix ................................................................................................................... 17 EVD PPE DONNING AND DOFFING CHECKLIST .......................................................................... 19 LEVEL 1 ................................................................................................................................................... 19 EVD PPE DONNING AND DOFFING CHECKLIST .......................................................................... 23 LEVEL 2 (N95) .......................................................................................................................................... 23
EVD PPE DONNING AND DOFFING CHECKLIST ............................................................................................ 26 LEVEL 3 (BUDDY) ............................................................................................................................... 26 Safety & Awareness Posters for 8M ....................................................................................................... 28 Rapid Extrication Incapacitated Staff in PPE (8m) ................................................................................. 32
Downtown Emergency Dept. EVD Operations .......................................................................................... 36 8M Unit EVD Operations ........................................................................................................................... 38
8M Opening Process: .............................................................................................................................. 38
Upstate Hospital EVD Guidance Downtown Campus Page 2 of 250
8M Staff Primary Evaluation and Feedback Process: ...................................................................................... 43 8M Clinical Staffing Process ....................................................................................................................... 44 Protecting Patient information ................................................................................................................ 44 Daily Clinical Meetings .......................................................................................................................... 44 Property Management for a diagnosed EVD Patient .............................................................................. 45 8m Security Coordination ........................................................................................................................... 45 8M unit access ......................................................................................................................................... 45 Visitors .................................................................................................................................................... 46 Upstate 8m Consultation & Intercom Use .............................................................................................. 46 EVD Equipment Log ................................................................................................................................. 47 Nursing Specimen Collection /ISTAT 8m ................................................................................................. 48 EVD Patient Discharge Process ................................................................................................................ 51
Exposure Management ................................................................................................................................ 52 Employee Monitoring Process .................................................................................................................... 54 Special Populations: Pediatrics/OBGYN .................................................................................................... 56 Upstate HCW EVD Health Monitoring Log ............................................................................................... 58 Patient Transfer Protocol (Internal & External) .......................................................................................... 59
UH Downtown to another EVD Center ................................................................................................... 59 Other Hospitals & Upstate Community Campus to Downtown Campus................................................ 59 Communications during Transfer............................................................................................................ 60 UH Outpatient Clinics to UH Downtown ................................................................................................. 60 Transport of EVD Patients from Downtown ED to Inpatient Room ........................................................ 60 EVD Direct Admit/EMS Integration for 8M ............................................................................................. 62
Environmental Infection Control/Waste ..................................................................................................... 68 Disposal of Body Fluids (Toilet & Shower) .............................................................................................. 70 Fluid Disposal Procedure (SOLIDIFICATION). .......................................................................................... 70 Patient Flush Procedure .......................................................................................................................... 71 Patient Shower Procedure ...................................................................................................................... 71 Bed Pan Solidification Procedure ............................................................................................................ 71 Category A Waste Removal EVD ............................................................................................................. 71
Spill Cleanup ................................................................................................................................................ 72 Category A Waste Handlin/ Packaging .................................................................................................... 74 EVS WASTE REMOVAL – Cold zone to Waste Staging Rm 8216.............................................................. 75 Class A Waste Travel Routes ................................................................................................................... 77 from ED................................................................................................................................................... 77 from 8M (Patient Care Area & POC Lab) ............................................................................................. 77 from 4 South (Designated EVD Entrance for EMS) ................................................................................. 78 Patient Room Cleaning Procedure 8M/ EVD ........................................................................................... 79 Anteroom Cleaning Procedure 8M/ EVD ................................................................................................ 80 EVD Sharps Container Removal .............................................................................................................. 82 Discharge EVD Warm/Hot Zone Cleaning ............................................................................................... 83
Dietary......................................................................................................................................................... 84 Support Services Employees & Family ...................................................................................................... 85 Communications/Public Relations .............................................................................................................. 87 Post Mortem Preparations ........................................................................................................................... 88 Restraints for a Diagnosed EVD Patient ..................................................................................................... 90 Pharmacy..................................................................................................................................................... 91 Aerosol Generating Procedures (AGPS) ..................................................................................................... 97 Central Line Placement for EVD Patients .................................................................................................. 98
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Chest X-Ray ................................................................................................................................................ 99 Highly Infectious Phlebotomy Protocol .................................................................................................... 102 Adult Continuous Renal Replacement Therapy (CRRT) .......................................................................... 104 Galileo Mechanical Ventilator .................................................................................................................. 111 Microbiology Procedure ........................................................................................................................... 113 POC 8M Laboratory ................................................................................................................................. 177
Hemochron Signature Elite ................................................................................................................... 189 Citrate Activated Partial Thromboplastin Lime Testing ........................................................................ 189 Hemochron Signature Elite ................................................................................................................... 198 Citrate Prothrombin Time ..................................................................................................................... 198 Hemochron Signature Elite ................................................................................................................... 207 Preventive Maintenance ....................................................................................................................... 207 Hemochrom Signature Elite .................................................................................................................. 213 Training Checklist .................................................................................................................................. 213 Hemochron Signature Elite ................................................................................................................... 214 General Operating Procedure ............................................................................................................... 214 Horiba ABX Micros 60 Analyzer ............................................................................................................ 222 General Operating Procedure ............................................................................................................... 222 Horiba ABX Micros 60 Analyzer ............................................................................................................ 231 Preventive Maintenance ....................................................................................................................... 231 Horiba Training Checklist ...................................................................................................................... 236 Piccolo Xpress ........................................................................................................................................ 237 General Operating Procedure ............................................................................................................... 237 Piccolo Xpress ........................................................................................................................................ 255 Preventive Maintenance ....................................................................................................................... 255 Piccolo Training Checklist ...................................................................................................................... 259
Upstate Outpatient & Ambulatory EVD Guidance: .................................................................................. 260 Appendix A: EVD Decontamination Zone Room Diagrams .................................................................... 265 Appendix B: Level 1 PPE: PAPR Initial Training Curriculum ............................................................... 269 Appendix C: Upstate EVD Steering Committee Improvement Process/Drill Planning .......................... 273 Appendix D : Upstate Departmental Disaster Plan 8M ........................................................................... 276 Appendix E : Upstate EVD Training Tracker Codes ............................................................................... 280 Appendix E: Rural Metro EMS EVD Policies ........................................................................................ 282 Appendix F : User guide CDESS for Employee Monitoring ................................................................... 291 Appendix F : 8m Video Monitoring User Guide ....................................................................................... 306
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Background
Ebola Viral Disease (EVD) is one of numerous Viral Hemorrhagic Fevers. It is a severe, often fatal disease
caused by infection with a virus of the family Filoviridae, genus Ebola virus.
Transmission
Direct contact (through broken skin or mucous membranes) with bodily fluids such as, but not limited to, blood,
urine, feces, sweat, semen, and breast milk of an infected person. Exposure to objects that have been
contaminated with infected secretions (such as needles) Direct handling of bats, rodents or primates from
disease endemic areas. EVD is not spread by an airborne route: Incubation period: 8–10 days (ranges from 2–21
days)
Case Definition
1) All Triage and Registration personnel must ask the following questions per NYSDOH Commissioners
Order of 10/16/14
a) Suspected Case
i) Clinical criteria: including:
(1) A international travel history within the last 21 days or any other country that CDC designates as
having a widespread EVD outbreak; and (2) any symptoms of EVD including fever, headache,
muscle pain, vomiting, diarrhea, abdominal pain, or unexplained hemorrhage. AND
(2) Epidemiologic risk factors within the past 21 day before the onset of symptoms as well as
contact with a patient known to have or suspected to have EVD;
ii) Questions asked by Registration/Clinical Staff to all patients presenting for care at all Upstate
facilities.
(1) Identify if patient is possible case:
(a) A suspected case is considered a confirmed case until proven otherwise
In the past 21 days has the patient been outside the United States?
(b) Has the patinet been near other people who have been diagnosed with Ebola?
(c) Does the patient have the symptoms of Ebola?
(i) Temprature: Greater than 38.6 C or 101.6 F
(ii) Severe Headache, Muscle Pain, Weakness, Diarrhea, Vommiting, Abdominal pain
Unexplained hemorrhage (bleeding or brusing)
(2) IF QUESTIONS (#Aand #C ) OR questions (#B and #C) are answered positive please follow
main EVD Guidance on ipage.
2) Confirmed Case
(1) A suspected case with laboratory-confirmed diagnostic evidence of EVD.
Upstate EVD Notifications Listing: Downtown Campus
1) Contact Administrative Supervisor
a) Notify them of event for the immediate activation of Incident Command.
(a) see DIS C-00
(2) Administrative Supervisor Downtown can utilize EVD Red Alert Messaging for activation of 8m
staff.
2) Notify University Police/Security ASAP
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3) Contact Hospital Epidemiologist: If one is unavailable call the other physician
a) Downtown Campus: W. Javaid Pager: 467-4529 Cell 315-447-3222
b) Community Campus: M. Brodey Cell only 315-382-3740
4) Administrative Supervisor will notify the following as soon as possible
a) Environmental Health and Safety
b) Laboratory Services: Laboratory Manager 315-882-5063, Microbiology Director 315-373-3074
c) Environmental Services Supervisor- At UH Via VOCERA 464-1400
d) Nursing staff manager for 8m
e) Onondaga County Health Department
i) Business hours: 315- 435-3252
ii) Evening: 315-435-3236
f) NYS Bureau of Communicable Disease Control if unable to reach OCHD
i) Business hours: 518-473-4439
ii) Evenings, weekends, holidays: 1-866-881-2809
iii) Follow and implement any additional recommendations
Risk of Exposure (cdc.gov)
“High Risk” Exposure Examples
1) direct contact with body fluids, from a person sick with Ebola and showing symptoms, through:
a) a needle stick
b) splashes to eyes, nose, or mouth
c) getting body fluids directly on skin
2) touching a dead body while in a country with a large Ebola outbreak without wearing recommended
personal protective equipment (PPE) or not wearing PPE correctly both living with and taking care of a
person sick with Ebola
3) If testing is believed to be required by Upstate contact the local or state health department immediately to
receive direction from them regarding EVD testing
“Some Risk” Exposure Examples
1) close contact (within 3 feet) of a person sick with Ebola for a long time
2) Direct contact with a person sick with Ebola (such as in a hospital) in a country with a large Ebola outbreak
even while wearing PPE correctly
“Low (but not zero) Risk” Exposure Examples
1) having been in a country with a large Ebola outbreak within the past 21 days with no known exposure (such
as NO direct contact with body fluids from a person sick with Ebola)
2) being in the same room for a brief period of time with a person sick with Ebola
3) brief direct contact, like shaking hands, with someone sick with Ebola
4) direct contact with a person sick with Ebola in the United States while wearing PPE correctly
5) traveling on an airplane with a person sick with Ebola
“No Risk” Exposure Examples
1) having contact with a healthy person who had contact with a person sick with Ebola
2) having contact with a person sick with Ebola before he or she had any symptoms
a) someone who left a country with a large Ebola outbreak more than 21 days ago and has not been sick
with Ebola since leaving that country
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b) having been in a country where there have been Ebola cases, but no large Ebola outbreak (for example,
Spain)
Personal Protective Equipment (PPE)
1) All hospital personnel involved in patient care will use PPE provided by Upstate.
2) NO SKIN EXPOSURE WHEN PPE IS WORN
3) Each Upstate employee must be monitored for proper donning and doffing and for fatigue while wearing
PPE.
4) If the normal supply chain is interrupted Upstate will seek additional PPE from other local hospitals not
impacted by the EVD patient and coordinate such supplies with NYSDOH/Onondaga County Department
of Emergency Management
5) Hospital has provided disposable shoes (crocs) are optional PPE intended only to those staff who do not
want to wear their own personal footwear. It is recommended that staff members utilize this footwear.
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Trained Observer Role Definition & Initial Training Guidance
**** Taken from current CDC recommendations regarding Ebola Treatment and PPE usage.
http://www.cdc.gov/vhf/ebola/healthcare-us/ppe/guidance.html
A Trained Observer primarily responsible for:
Monitoring compliance with PPE protocols for EVD
Guiding, correcting PPE during donning and doffing.
Protecting Themselves
Anticipating and planning for risks or situations that may demand a higher level of safe operations or
urgent situations in which highly trained personnel on site may assist clinical providers engaged in the
care of an EVD patient.
Ensure that the entry and exit Log of all healthcare workers who enter the unit is completed per
NYSDOH guidelines. Ensure that this contact log is communicated to Incident Command or Employee
Health at the end of each shift.
Use of a Trained Observer
1. Because the sequence and actions involved in each donning and doffing step are critical to avoid
exposure, a trained observer should read aloud to the healthcare worker each step in the procedure
checklist and visually confirm and document that the step has been completed correctly.
a. Remember to use verbal and explicit closed-loop communication for each step in the process.
b. Ideally, as the Trained Observer, you tell the health care provider what step to perform, they
verbalize back the task to ensure they understood, and you as the observer verbalize completion.
2. The trained observer has the sole responsibility of ensuring that donning and doffing processes are
adhered to.
3. The trained observer must be knowledgeable about all PPE recommended in the facility’s protocol and
the correct donning and doffing procedures, including how to dispose of used PPE, and must be
qualified to provide guidance and recommendations to the healthcare worker.
4. The trained observer will coach, monitor all donning and doffing procedures, and provide immediate
corrective instruction if the healthcare worker is not following the recommended steps.
5. However, the trained observer should NOT provide physical assistance during doffing, which would
require direct contact with potentially contaminated PPE.
6. The trained observer should know the exposure management plan in the event of an unintentional break
in procedure.
Role Clarity
1. Safety demands active communication by the Trained Observer and the healthcare worker it is up to the
Trained Observer to lead the process and not be a casual observer.
2. The safety of the healthcare worker should be the top priority.
a. Help them by establishing clear roles. Let them know you are here to help and guide them
through the process.
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3. Anticipate any challenges you might face by practicing and identifying steps that may have require extra
diligence or verbal explanations for the healthcare worker.
a. It is your job to put them at ease and keep them at a slow and methodical pace. By asserting
your leadership, you can keep them calm and in the proper frame of mind as they are donning
and doffing equipment, and preparing to attend to the patient.
4. Before beginning either the donning or doffing process, it may help to establish proper communication
protocols.
a. Work with the providers to establish ‘red flag’ words so that any situations can be handled by all
parties involved. Use closed-loop communication for clarity. For example, whenever you need to
give a command, have the healthcare worker repeat the command back, so there are no
misunderstandings.
5. Your role as the Trained Observer goes beyond reading the checklist.
a. You should proactively sensitize the health care provider to risks at different steps of the process.
For example, when a health care provider removes their protective head gear, they may be likely
to inadvertently wipe their brow or push their hair back. When providing directions for these
steps, you can offer supportive comments and reminders to be careful not to make those slips.
S.T.E.P. practice
1. Use the STEP practice to make sure the physical surroundings promote safety.
2. Situation –
a. What is my situation? Do we have correct PPE in the needed sizes? Is the equipment functioning
properly?
b. Is the process set up to ensure safety for you and the healthcare providers before and after
attending to the patient?
3. Team members –
a. Be familiar with the protocols for donning and doffing PPE.
b. Are the proper people involved?
c. Are they fatigued or feeling anxiety? Are you making them feel safe?
d. Are they wearing and using the proper PPE? Has everyone been trained on the process properly?
4. Environment –
a. Anticipate any contamination of areas, surfaces or equipment. Is the room set up for donning or
doffing properly?
b. Are the required waste receptacles available? Do you have properly marked clean and dirty
chairs?
c. Is the proper signage posted where it needs to be?
5. Progress toward goal –
a. Be prepared with the latest procedures, and know them to the point you feel comfortable leading
others through them. Do you have the latest checklist? Are you maintaining a connection with
the healthcare worker you are assisting? Are you getting verbal confirmation as you complete
each step?
Principles of PPE during an EVD Patient:
1. Healthcare workers must follow the basic principles below to ensure that no infectious material reaches
unprotected skin or mucous membranes while providing patient care.
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2. Donning
a. PPE must be donned correctly in proper order before entry into the patient care area; PPE should
not be later modified while in the patient care area. The donning activities must be directly
observed by a trained observer.
3. During Patient Care
a. PPE must remain in place and be worn correctly for the duration of work in potentially
contaminated areas.
b. PPE should not be adjusted during patient care. In the event of a significant splash, the healthcare
worker should immediately move to the doffing area to remove PPE.
c. Healthcare workers should perform frequent disinfection of gloved hands particularly after
contact with body fluids.
d. If during patient care any breach in PPE occurs (e.g., a tear develops in an outer glove, a
needlestick occurs, a glove separates from the sleeve), the healthcare worker must move
immediately to the doffing area to assess the exposure.
e. The SUNY Upstate exposure management plan should be implemented; including correct
supervised doffing and appropriate employee health follow-up
4. Doffing
a. Removing used PPE is a high-risk process that requires a structured procedure, a trained
observer, a “suit buddy” all operate in the designated area for PPE removal to ensure protection.
b. PPE must be removed slowly and deliberately in the correct sequence to reduce the possibility of
self-contamination or other exposure to Ebola.
Donning: The Trained Observers Role in Donning
1. The Trained Observer’s role in the donning process has three major components.
a. Guide the healthcare provider through donning according to the checklist.
i. All instructions from the checklist need to be verbally confirmed – closing the
communications loop – before they are acted on.
ii. Assuring successful completion of each donning step is one of your major roles.
b. As you are both in a clean area, you may, if needed, assist the health care provider in donning
their PPE as necessary.
c. To ensure safety, continually scan your colleagues’ PPE and the environment for possible
contamination risks during donning.
d. The checklist is a memory aid that structures the donning process.
e. Remember to use verbal and explicit closed-loop communication for each step in the process.
i. Ideally, as the Trained Observer, you tell the health care provider what step to perform,
they verbalize back the task to ensure they understood, and you as the observer verbalize
completion.
f. Completion also means a thorough check to ensure no part of the PPE is ripped, torn or
otherwise vulnerable to contamination.
Donning: Pre-Donning Briefing
1. The donning process begins when you and the health care provider engage one another and verbally
review the protocol.
2. This timeout or Pre-Briefing will involve several important parts.
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a. Both of you should first confirm that all PPE and other necessary supplies are available,
conveniently located, correctly sized, and in good working order, free of any rips or tears.
b. Together, you should run through the order of activities on the checklist, setting expectations
about the timeline and agreeing on a slow, steady and deliberate pace for completing the donning
process. In addition to establishing closed loop communication, make sure there is a common
understanding of what you will do if something unexpected happens.
Donning: Error Catching and Pro-active Assistance
1. Acting as a guide and protector means you are proactive about identifying breaches of protocol and
possible points of contamination.
a. As examples, when you and your colleague begin the donning process you may notice that they
are still wearing jewelry, or ID badges.
b. Be sure those are removed prior to donning any equipment as they can cause rips or tears to the
PPE.
2. Draw items like cell phones and ID badges to your colleague’s attention well before they don any PPE.
3. These are items which can be easily forgotten about as we have them on our person every day. A good
time to do a final check may be when they first change into their fresh surgical scrubs.
4. Other examples of proactive risk monitoring during doffing might include identifying issues with
equipment, identifying placement and fit issues with PPE and maintaining control of the pace of the
donning process.
5. These are only a few examples. Your role is to protect by using common sense. Don’t simply depend on
what is on the checklist, proactively monitor for any contamination risks.
Doffing: the Trained Observer’s Role in Doffing
1. The Trained Observer’s role in the doffing process is to guide the healthcare provider, and in some cases
the Suit Buddy, through the doffing process using the checklist provided.
2. As with donning, you must ensure doffing proceeds at a slow, deliberate and methodical pace.
3. Continually scan your colleagues’ PPE and the environment for possible contamination risks during
doffing.
4. Always engage in confirmatory, closed-loop communications with the health care providers and doffing
assistants you are guiding.
5. You should assure successful completion of each doffing step, remembering that completion means a
removed item is intact and has not touched ‘clean’ areas and has been disposed of properly in the
available waste container and has not contaminated any staff members.
Doffing: Role Clarity for Suit Buddy
1. In cases where you will be assisting a colleague wearing a PAPR, or an N95 Respirator combined with a
coverall, a third person will be needed. It is your role, as the Trained Observer, to ensure this person -
called a Suit Buddy - is available and also wearing appropriate PPE. The Suit Buddy should be well-
trained on the protocols as well.
2. Remaining outside the doffing area, you will observe and guide as a Suit Buddy inspects the health care
provider for any signs of contamination.
3. Any areas that are identified as contaminated should be disinfected using approved wipes.
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4. The Suit Buddy is to provide a minimum of direct assistance to the health care provider.
5. If they do assist the healthcare provider directly, it is your job to ensure they immediately perform hand
hygiene.
6. You will remain outside the doffing area, guiding and pacing without coming into contact with your
colleague.
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8 and
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15
EVD PPE Roles & Training Matrix
Primary Staff
member/ Health
Care Worker
(HCW)
Suit Buddy Trained Observer
(aka- CDC Site Manager)
POC
Laborator
y
Personnel
Environmen
tal Services
University
Police/ Public
Safety
Registration
Staff
Outpatient/Ambul
atory Clinical
Staff
Physical
Plant
PPE Level 1 (PAPR) or
Level 2 (N95) Level 3 NONE Level 3
Level 2 or 3
depending on task
surgical mask &
double glove surgical mask
surgical mask &
double glove
Level 1 or
Level 2
Role Upstate Employee
directly engaged in the care of a patient
with EVD (Nurse,
Physician)
Tasked with actively
monitoring and
assisting the HCW/Staff member
with correctly
donning and doffing PPE, observing staff
members for
increased fatigue or possibility of injury,
breaks in PPE.
Measuring vitals of the primary staff
member prior to
donning and after doffing.
To provide direct onsite
management and oversight for
the overall safe operation of all
staff members engaged in the care of an EVD patient. The
Trained observer must
implement both administrative and environmental controls by
continuous safety checks through
direct observation. They must be able to take immediate corrective
action once a breach in PPE or
unsafe environment has been identified. In addition they must
ensure the completion of the
EVD exposure log and that information is communicated to
Employee Health at the end of
every shift. Ensure completion of the employee monitoring form
once HCW/Staff member is out
of the PPE. Ensures proper measuring and recording vital
signs and looking for signs of
fatigue both during donning and doffing. Also ensure appropriate
personnel are on standby to
assist if someone who is currently wearing PPE becomes
injured.
Process and analyze
clinically
required specimens
in the POC
lab on 8m for an EVD
patient
Waste
removal and cleaning for
an EVD
patient
Law Enforcement
and area
security as it relates to an
EVD patient.
Asks all
presenting
patients Initial EVD Screening
questions as
indicated in Upstate's
guidance and
communicates any suspect
cases to clinical
staff members/ Triage Nurses.
Coordinates the
isolation and
communications per Upstate EVD
guidance to ensure
a minimum amount of patient contact.
Must be able to
integrate with local EMS as needed.
Repairs as
needed to
physical space
impacted by
an EVD patient.
Upstate Hospital EVD Guidance Downtown Campus Page 16 of 250
Qualifications
Job specific and/or
PPE specific training as
designated by
Upstate Hospital for
the role expected to
be engaged in
surrounding the care, transport or
waste management
of an EVD patient.
The Suit Buddy will
be knowledgeable
about all PPE in Upstate's EVD
Guidance.
Specifically they
should be well
versed in the correct
donning and doffing procedures, disposal
of used PPE and
their role in the EVD exposure plan
The trained observer will be very
knowledgeable about all the PPE components in Upstate's EVD
response. Specifically they
should be well versed in the correct donning and doffing
procedures, waste disposal and
qualified to provide on the spot
guidance as needed. In addition,
The trained observer should be
able to implement the EVD exposure management plan in
the event of an unintentional
break in procedure by possessing an above average awareness of
the resources available to them
in such a situation.
Job specific and/or PPE specific training as
designated by Upstate Hospital for the role
expected to be engaged in surrounding the care,
transport or waste management of an EVD
patient.
As indicated by Upstate's
department of
Human Resources and
Supervisors
within the Department for
the screening of
all patients presenting for
care at Upstate.
Job specific and/or
PPE specific training as
designated by
Upstate for the role expected to be
engaged in
surrounding the care, transport or
waste management
of an EVD patient as it occurs in an
outpatient or
ambulatory setting
Job specific and/or PPE
specific
training as designated
by Upstate
Hospital for the role
expected to
be engaged in
surrounding
the care, transport or
waste
management of an EVD
patient.
Reports to: Direct Supervisor or
trained observer
when in PPE
Direct Supervisor or
trained observer
when in PPE
Direct Supervisor or Safety
Officer if Incident Command has
been activated
Direct Supervisor or others as indicated by Incident Command
PPE Level 1 (PAPR) or
Level 2 (N95) Level 3 NONE Level 3
Level 2 or 3 depending on
task
surgical mask &
double glove surgical mask
surgical mask &
double glove
Level 1 or
Level 2
Training Required
Monthly verified PPE donning/doffing training sessions per NYSDOH Commissioners order (10/16/14) in the
presence of Upstate Super-User. Also drills and exercises as determined by EVD Steering Committee. Each
employee needs to complete the appropriate respirator fit-testing program per Upstate policy in Employee Health
in addition to a current and acceptable medical evaluation on file per normal policy.
Blackboard
Class on
identification
and isolation of
a suspected
EVD patient
Monthly EVD
identification and isolation
Drills per
NYSDOH Commissioners
order (10/16/14)
Monthly EVD
identification and
isolation Drills per
NYSDOH
Commissioners
order (10/16/14)
Training will
occur only if
a critical need for one
of these staff
members to enter the
warm or hot
zone arises.
17
EVD PPE “on-hand” Matrix
Upstate PPE USAGE ESTIMATION FOR 1 EVD patient (CDC Minimum Days on Hand =7 days)
Assumptions: Location Title Estimated #
staff per shift
Shifts per Day
Suits per Day
Total # of People who
need PPE per day (Level 1,2 &
3)
level 1 or 2 PPE
8m Shifts are 12 hrs long (2 shifts per day); ED EVD
"shift" would be less than 12hrs as they would be
transported to 8m ASAP on the first day.
8m Physician 1 2 2
52
8m RN 4 2 8
ED Physician 2 1 2
ED RN 4 1 4
ED/8m Enviro Services 3 3 9
Level 3 PPE (Buddy)
ED EVD "shift" would be less than 12hrs as they would be transported to 8m ASAP on
the first day.
8m Physician & Rn 2 2 4
ED Physician & Rn 2 2 4
POC Lab Lab 5 2 10
ED/8m Enviro Services 3 3 9
# on Hand right now # est. used in 7
days Est. Use per day
Overage/ shortage
Days on Hand
Minimum PPE
Allowed Vendor Mfg.
PAPR Hoods 275 112 16 163 17.19 125 Grainger LC DOVER
PAPR filters 500 112 16 388 31.25 125 Grainger LC DOVER
TYCHEM Suits 601 175 25 426 24.04 175 MDS DuPont
Face Shields 451 364 52 87 8.67 400 Medline Medline
Cowls 940 364 52 576 18.08 400 Fisher DuPont
Gown 495 364 52 131 9.52 400 MMS MMS
Outer Glove (Nitrile) 400 364 52 36 7.69 400 Fisher sol-vex
Boot Covers 600 364 52 236 11.54 400 Medline Medline
N95 masks 103125 364 52 102761 1983.17 400 MMS Kimberly Clark
In the event of a diagnosis of EVD in a suspected patient a pre-set PPE order would be initiated
by incident command through our normal supply chain for the following items in order to
increase our inventory of essential PPE.
# on Hand right now Days on Hand
Pre- determined
order (if EVD confirmed)
Days on Hand w/
order (if EVD confirmed)
PAPR Hoods 275 17.19 400 42.19
PAPR filters 500 31.25 400 56.25
TYCHEM Suits 601 24.04 600 48.04
Face Shields 451 8.67 1200 31.75
Cowls 940 18.08 1200 41.15
Gown 495 9.52 1200 32.60
Outer Glove (Nitrile)
400 7.69 1200 30.77
Boot Covers) 600 11.54 1200 34.62
N95 masks 103125 1983.17 0 1983.17
EVD PPE DONNING AND DOFFING CHECKLIST
LEVEL 1 Equipment needed: washable clogs, suit, PAPR, HEPA cartridges, hood, trauma gown, outer gloves (green), inner gloves (Nitrile) and Chem Tape. ***for the purpose of this document “Bleach wipe” refers to Clorox Healthcare Bleach Germicidal Wipes *** Dwell time: three minutes
TOPIC Completed?
Have the 3rd person (Trained Observer) calling out each step, wait for (trained observer)
DO NOT RUSH THIS PROCESS
Pre Donning Instructions: The COLD ZONE (Clean Area):
1. Before donning with PPE
receive Safety Briefing
make sure to take bathroom break
drink fluids
secure belongings including jewelry, cell phone, watch, Vocera, etc. in staff locker
For staff with long hair, pull back with hair tie.
2. Change out of clothes into hospital scrubs.
3. Tuck shirt into waist band and tuck scrub pant legs into socks or tape.
4. Change into washable shoes (Hospital provided clogs).
5. Checking vitals: make sure to check vitals of both the person going in the room and the buddy. Document on staff tracking form.
PAPR ASSEMBLY
1. Both the Care Provider and Suit Buddy:
Inspect breathing tube, connections, and body
Look for gaskets,
Look for any breaks in the tube,
Obtain 2 new (sealed in foil) PAPR filters
Inspect for expiration date
Pull tabs on filters to allow for airflow
Check threading of filters and PAPR
Secure filters “hand tight” do not over tighten
Make sure the battery is fully charged.
2. Air Flow
Insert the air flow indicator into the blower opening on the top of the PAPR
Turn the blower on
The plastic cone should rise above the minimum flow mark
If the indicator fails to rise to this level, check the battery, and make sure the caps are removed from the filters/cartridges
If still fails to rise to this level or PAPR alarms, do not use PAPR
TOPIC Completed?
3. PAPR hood assembly
Check that the breathing hose thread has the black rubber gasket seal
Check the threads in the blower unit is in good condition and clear of foreign matter
Screw the end of the breathing hose into the blower unit until it is hand tight
Do not over tighten!
Connect the tube to the head piece, screw the end of the breathing hose until it is hand tight
Do not over tighten!
PPE & Supplies Check 1. Inspect ALL personal protective equipment for any rips or tears and signs of wear.
2. Position a cleanable table with a blue wrap available in the COLD ZONE for the doffing process.
3. Suit Buddy will rip (3) 12” pieces of ChemTape.
4. Suit Buddy will attach zipper tab to suit.
Donning: The COLD ZONE (Clean Area):
1. Put washable clogs on.
2. While sitting place feet into personal protective suit.
3. Stand and Pull suit up to waist.
4. Put first set of inner gloves on (Nitrile).
5. Put arms into suit and bring suit up to shoulders.
6. Ensure the sleeve of the suit completely covers the inner glove to the wrist.
7. Buddy assists with donning the green outer gloves
Place the green outer gloves over first set of gloves and arms of suit
Ensure that inner gloves are tucked under sleeve of the suit
8. Tape green outer gloves to outside of suit and make tabs on end of Chem Tape for ease in removal.
Marry glove to suit and be sure to check for any exposure or gaps.
9. Zip suit above waste.
10. Partially close flap of suit
11. Buddy holds the PAPR blower unit and assists the Care Provider in securing the belt
Ensuring the belt holders are secured in place.
Adjust belt as needed for a snug fit.
12. Buddy turns the PAPR blower unit button ON.
13. Put PAPR hood over head, pulling chin strap securely under chin.
14. Tuck inner bib of the PAPR hood into the suit
15. Zip suit up completely up
16. Seal the flap of suit. Use Chem tape as needed.
17. Put Trauma gown over suit
Tie in back at neck and waist.
Ensure the trauma gown does not obstruct the PAPR blower motor by securing the trauma gown waist tie underneath the blower motor.
TOPIC Completed?
18. Buddy conducts visual inspection of Care Provider to ensure PPE is properly donned.
Once the Care Provider is fully donned, the Buddy should put on the Buddy Suit: Level 3 PPE
Note: When in Hot Zone, if any breech in PPE or Contamination occurs, the Care Provider must stop, disinfect with bleach wipe, come into Warm Zone, doff PPE and follow the Exposure Procedure.
Doffing Instructions: Have a 3rd person (Trained Observer) calling out each step, DO NOT RUSH THIS PROCESS.
While Care Provider is the Hot Zone (Patient Room)
If grossly contaminated, wipe down as much contaminates using Bleach wipes as possible while still in the Hot Zone (patient room). (3 minute dwell time)
1. Carefully remove trauma gown by criss crossing arms and carefully pull gown at shoulders to breaking top attachment point
2. Turn sleeves and gown inside out while rolling gown away from your body 3. Once detached and completely rolled up place gown in rigid waste container. 4. Pause to inspect your PPE again for any gross contamination
1. Wipe hands with Bleach wipe (discard wipe) and wait Dwell time: 3 minutes 2. Wipe door knob with second Bleach wipe (do not need to wait dwell time) 3. While using the Bleach wipe to open door step into Warm Zone. 4. Discard wipe in warm zone ridged waste container.
HOT TO WARM ZONE TRANSISTION 1. The Buddy stays in the Cold Zone at all times. 2. The Care Provider is in the Warm Zone.
If the Buddy steps into Warm Zone, the Buddy must stay in the Warm Zone and follow decontamination doffing process.
If the Care Provider becomes contaminated at any point of this process, STOP, clean with Bleach wipes, document exposure and follow Exposure Procedure.
1. Care Provider in suit should stand on the blue wrap inside the Warm Zone at all times.
2. Buddy ensures the table (adjust height related to Care Provider) with blue wrap is set up in the COLD ZONE on the edge of the warm zone for placement of PAPR blower.
3. Bleach Wiping procedure:
Buddy hands Care Provider a new Bleach wipe to wipe gloves between select doffing steps or when a breach in protocol occurs.
Wait appropriate Dwell time: 3 minutes.
Discard wipe immediately after each step.
DOFFING PROCESS in Warm ZONE 1. Buddy verbally assists Care Provider with backing up to the table.
2. Buddy will grasp the PAPR and instruct the Care Provider to unbuckle the PAPR belt
3. Buddy tells Care Provider they will be disconnecting the air.
4. Buddy disconnects the PAPR hose attached to the hood and places it on the table.
5. Buddy Turns PAPR off. Buddy wipes gloved hands. (3 minute dwell time)
6. Care Provider in suit leans head forward then pulls the PAPR hood off and places in rigid waste container used for bio-hazardous waste. Care Provider wipes gloved hands. (3 minute dwell time)
7. Care Provider in suit will open flap and completely unzip suit.
TOPIC Completed?
8. The Care Provider reaches behind and pulls suit off shoulders and down to waist.
9. With arms behind back grab outer glove from behind to free inner gloved hand.
10. Use clean hand with inner glove inside of suit to free other hand from sleeve and outer glove.
11. Carefully roll suit inside out down to knees being sure not to touch outside of suit.
12. The Buddy will position a clean chair on edge of Cold and Warm Zones so that the Care Provider will face the Warm Zone with feet and suit in Warm Zone.
The chair must always remain in the cold zone
13. Care provider pulls legs out of suit one leg at a time and carefully keeps feet in suit or stand in suit until both legs are out of PPE Suit.
Care providers feet CANNOT touch warm zone area including the blue wrap.
14. While still sitting in chair the Care Provider pivots and steps out into the Cold Zone.
15. Care Provider wipes gloved hands. (3 minute dwell time)
16. Care provider takes inner gloves off, discarding them in ridged waste container.
17. Wash hands with hand sanitizer or soap and water for at least 30 seconds.
18. Care Provider showers and changes into clean scrubs.
19. Document vitals on medical evaluation form when finished.
Cleaning up the Warm Zone (Suit Buddy) 1. Trained Observer will guide Buddy on cleaning of PAPR and warm zone
2. The Buddy should watch to make sure the chair used during donning/doffing does not become contaminated if a breach in suit, visual contamination, or the suit accidently touched the legs of the chair during the doffing process. If the chair becomes contaminated, the Buddy should wash with Bleach wipes.
3. Buddy wipes the PAPR blower unit and waist strap down with Bleach wipes and leaves on table. Buddy disinfects gloved hands with bleach wipe allowing for appropriate dwell time: 3 minutes.
4. The buddy will remove the HEPA filters from the PAPR then place in waste bin.
5. Buddy will disconnect PAPR hose from PAPR then wipe hose with disinfectant wipe. After wiping with bleach wipe place clean hose on clean surface in cold zone.
6. Buddy will disconnect the belt from the PAPR then wipe belt with disinfectant wipe and place in the cold zone.
7. Buddy will wipe PAPR with disinfectant wipe then place on clean surface in cold zone.
8. The Buddy will gather up blue wrap carefully rolling dirty surface inward, and place in rigid container. Buddy will wipe gloved hands. (dwell time 3 minutes)
9. The washable shoes worn by the Care Provider are clean and should be wiped with Bleach wipe and returned to the PPE equipment area. (dwell time 3 minutes)
10. Buddy will follow waste procedure to bag up waste in the warm zone.
11. Buddy will follow buddy doffing procedure.
12. Wash up /Shower per Protocol and change into clean clothes.
13. Document vitals of the Buddy on medical evaluation form when finished.
EVD PPE DONNING AND DOFFING CHECKLIST
LEVEL 2 (N95) PPE ATTIRE NEEDED: washable clogs, suit, N95, face shield, cowl (hood), trauma gown,
outer gloves (green), and inner gloves (Nitrile) and Chem Tape.
***for the purpose of this document “Bleach wipe” refers to Clorox Healthcare Bleach Germicidal Wipes *** Dwell time: considered at least three minutes at a minimum.
TOPIC Completed?
Have the 3rd person (Trained Observer) calling out each step, wait for (trained observer)
DO NOT RUSH THIS PROCESS
Pre Donning Instructions: The COLD ZONE (Clean Area):
1. Before donning with PPE
receive Safety Briefing
make sure to take bathroom break
drink fluids
secure belongings including jewelry, cell phone, watch, Vocera, etc. in staff locker
For staff with long hair, pull back with hair tie.
2. Change out of clothes into hospital scrubs.
3. Tuck shirt into waist band and tuck scrub pant legs into socks or tape.
4. Change into washable shoes (Hospital provided clogs).
5. Checking vitals: make sure to check vitals of both the person going in the room and the buddy. Document on staff tracking form.
PPE & Supplies Check 1. Inspect ALL personal protective equipment for any rips or tears and signs of wear.
2. Have a cleanable table with a blue wrap available in the COLD ZONE for the doffing process.
3. Suit Buddy will rip (3) 12” pieces of Chem Tape. 4. Suit Buddy will attach zipper tab to suit.
Donning: The COLD ZONE (Clean Area):
1. Put washable clogs on.
3. While sitting place feet into personal protective suit.
4. Stand and Pull suit up to waist.
2. Put first set of inner gloves on (Nitrile).
5. Put arms into suit and bring suit up to shoulders, ensuring that the sleeve of the suit completely covers the inner glove to the wrist.
6. Trained Observer will review the proper way to put on N-95 and Employee will
then put on N-95.
5. Buddy assists with donning the green outer gloves:
Place the green outer gloves over first set of gloves and arms of suit
Ensure that inner gloves are tucked under sleeve of the suit
6. Tape green outer gloves to outside of suit and make tabs on end of Chemtape for ease in removal.
Marry glove to suit and be sure to check for any exposure or gaps.
7. Place Cowl/hood over head and N 95 mask.
8. Tuck hood inside suit.
9. Zip suit up.
10. Seal the flap of suit with Chem Tape
11. Place a 4” piece of Chem tape from the front of cowl to chest.
12. Put Trauma gown over suit and tie in back at neck and waist.
13. Put face shield on and secure shield in place with tabbed Chem Tape on each side of head.
Note: No exposed skin or hair of the employee in the suit should be visible at the conclusion of the donning process.
HOT TO WARM ZONE TRANSISTION Have a 3rd person (Trained Observer) calling out each step, wait for caller do not rush this process
The Buddy stays in the Cold Zone at all times.
The Care Provider is in the Warm Zone.
If the Buddy steps into Warm Zone, the Buddy must stay in the Warm Zone and follow decontamination doffing process.
If the Care Provider becomes contaminated at any point of this process, STOP, clean with Bleach wipes, document exposure and follow Exposure Procedure.
Doffing Instructions: Before leaving the Hot Zone (Patient Room) to go into the Warm Zone:
If grossly contaminated, wipe down as much contaminates using Bleach wipes as possible while still in the Hot Zone (patient room) (Dwell time 3 minutes)
Carefully remove trauma gown by criss crossing arms and carefully pulling gown at shoulders, rolling gown inside out and place in rigid waste container
Place all materials in the rigid waste container in the patient room
Wipe hands with Bleach wipe
Discard wipe
Wait Dwell time: 3 minutes
Wipe door knob with Bleach wipe and while using wipe open the door (No need to wait dwell time)
Step into Warm Zone
Discard wipe
1. Care Provider in PPE should be standing on the blue wrap inside the Warm Zone.
2. Bleach Wiping procedure:
Buddy hands person in suit a new Bleach wipe to wipe gloves between select doffing steps or when a breach in protocol occurs
Wait appropriate Dwell time: 3 minutes after each step
Discard wipe immediately after each step
3. Care Provider in suit leans head forward near rigid waste container designated for bio-hazardous waste.
4. With two hands the care provider pulls shield and cowl off by placing hands on straps on side of shield (pulling off both the face shield and cowl over head at the same time).
Care Provider wipes hands with Bleach wipe (Dwell time 3 minutes)
5. Care Provider will open flap and completely unzip suit.
6. The Care Provider reaches behind and pulls suit off shoulders and down to waist.
7. With arms behind back grab outer glove from behind to free inner gloved hand.
8. Use clean hand with inner glove inside of suit to free other hand from sleeve and outer glove.
9. Carefully roll suit inside out down to knees being sure not to touch outside of suit.
10. The Buddy will position a clean chair on edge of Cold and Warm Zones so that the Care Provider will face the Warm Zone with feet and suit in Warm Zone.
The chair must always remain in the cold zone
11. Care provider pulls legs out of suit one leg at a time and carefully keeps feet in suit or stand in suit until both legs are out of PPE Suit.
12. While still sitting in chair the Care Provider pivots and steps out into the Cold Zone.
13. Care Provider wipes gloved hands. (3 minute dwell time)
Care providers feet CANNOT touch warm zone area including the blue wrap.
14. Lean head forward and grasp front of N-95 mask:
pull outward until elastic straps come off head
drop N 95 mask onto blue wrap in warm zone
15. Care provider takes inner gloves off, discarding them in ridged waste container.
16. Wash hands with hand sanitizer or soap and water for at least 30 seconds.
17. Care Provider showers and changes into clean scrubs.
18. Document vitals on medical evaluation form when finished.
Cleaning up the Warm Zone (Buddy) 1. The Buddy will gather up blue wrap carefully rolling dirty surface inward, and place
in rigid container. Buddy will wipe gloved hands. (dwell time 3 minutes)
2. The washable shoes worn by the Care Provider are clean and should be wiped with Bleach wipe and returned to the PPE equipment area. (dwell time 3 minutes)
3. Buddy will follow waste procedure to bag up waste in the warm zone.
4. Buddy will follow buddy doffing procedure.
5. Wash up /Shower per Protocol and change into clean clothes.
6. Document vitals of the Buddy on medical evaluation form when finished.
EVD PPE DONNING AND DOFFING CHECKLIST
LEVEL 3 (BUDDY) PPE ATTIRE: Equipment needed: N95, face shield, cowl/hood, trauma gown, (2) pair of gloves (Nitrile), knee high boot covers. ***for the purpose of this document “Bleach wipe” refers to Clorox Healthcare Bleach Germicidal Wipes *** Dwell time: considered at least three minutes at a minimum.
TOPIC Completed?
Have the 3rd person (Trained Observer) calling out each step, wait for (trained observer)
DO NOT RUSH THIS PROCESS
Pre Donning Instructions: The COLD ZONE (Clean Area):
1. Before donning with PPE
receive Safety Briefing
make sure to take bathroom break
drink fluids
secure belongings including jewelry, cell phone, watch, Vocera, etc. in staff locker
For staff with long hair, pull back with hair tie.
2. Change out of clothes into hospital scrubs.
3. Tuck shirt into waist band and tuck scrub pant legs into socks
4. Change into washable shoes (Hospital provided clogs).
5. Document vitals on medical evaluation form
Donning: The COLD ZONE (Clean Area):
Have a 3rd person (Trained Observer) calling out each step, DO NOT RUSH THIS PROCESS.
1. Put on boot covers over disposable shoes.
2. Put on inner nitrile gloves.
3. Put on outer nitrile gloves.
4. Put on N95.
5. Put on hood/Cowl.
6. Put on gown - Note: sleeves should cover inner gloves.
7. Put on face shield.
8. Place two small pieces of Chem Tape around face shield band to secure it to the hood.
9. Place a 4” piece of Chem Tape from the front of cowl to chest.
The Buddy is now ready to work in the Cold Zone
The Buddy stays in the Cold Zone at all times.
If the Buddy steps into Warm Zone, the Buddy must stay in the Warm Zone and follow decontamination doffing process.
Doffing Instructions: Have a 3rd person (Trained Observer) calling out each step, DO NOT RUSH THIS PROCESS.
TOPIC Completed?
1. Decontaminate hands using Bleach wipe.
Wait appropriate Dwell time: 3 minutes
Discard wipe when done.
2. Remove boot covers. (Use chair as needed to maintain balance)
3. Decontaminate hands using Bleach wipe.
Wait appropriate Dwell time: 3 minutes
Discard wipe when done
4. Remove outer gloves being careful not to contaminate inner gloves.
5. Decontaminate hands using Bleach wipe.
Wait appropriate Dwell time: 3 minutes
Discard wipe when done.
6. Remove hood and face shield together.
7. Decontaminate hands using Bleach wipe.
Wait appropriate Dwell time: 3 minutes
Discard wipe when done.
8. Remove gown rolling it inside out.
9. Decontaminate hands using Bleach wipe.
Wait appropriate Dwell time: 3 minutes
Discard wipe when done.
10. Remove N95
11. Decontaminate hands using Bleach wipe.
Wait appropriate Dwell time: 3 minutes
Discard wipe when done.
12. Remove gloves.
13. Wash hands with soap and water for at least 30 seconds.
14. Put on new pair of gloves to bag up buddy PPE waste.
Follow waste bagging procedures
15. Decontaminate hands using Bleach wipe.
Wait appropriate Dwell time: 3 minutes
Discard wipe when done
16. Discard gloves in red waste bin.
17. Wash hands with soap and water for at least 30 seconds.
18. Wash up /Shower per Protocol and change into clean clothes.
19. Document vitals of the staff monitoring form when finished.
Safety & Awareness Posters for 8M
The following are posters created to promote an increased awareness for certain actions such as donning
and doffing. These posters do not take the place of the checklists created as a step by step guide for the
trained observer to read.
EVD Procedure
Procedure Issue Date: 2/16/15 Applies to: Downtown
Last Revision Date: 2/16/15
Last Review Date: 2/16/15
Rapid Extrication Incapacitated Staff in PPE (8m)
Number of Staff Needed: 1 buddy RN, 1 standby Rn, Trained Observer, Code Response
team (if needed), Trained ED EVD personnel,
Equipment: Backboard, Trauma Scissors, Mega Mover, C- Collar, stretcher or bed from
ED.
Purpose: The primary focus of this procedure is to clinically stabilize life threatening injuries or
conditions while minimizing exposure to EVD when a staff member is located in the patient’s
room on 8m while wearing level 1 PPE.
Assumptions:
1) Primary Care Staff Member (or the injured person while located inside the hot zone)
becomes injured or incapacitated in such a way to jeopardize the physical safety of that
person or impair their ability to doff safely under the normal established process. Additional
personnel must be sent in to the hot zone in order to assist them maintain a safe working
environment.
2) The Trained Observer & Suit Buddy will observe the Primary Care Staff Member for signs
of heat stress or other potential opportunities for injury in order to prevent this from ever
happening.
3) A 3rd
fully trained RN, not actively engaged in other duties, will be placed on “stand-by” in
case the need for additional resources becomes apparent. That 3rd
“stand by” RN will not
leave 8m without suitable replacement being found and integrated in to the process.
4) At no time does the Trained Observer enter the room during this process.
5) Every effort should be made to minimize additional injury to the staff member during this
extrication process. Balancing the urgent need to remove them from the hot zone & PPE
quickly with reducing the possibility of exposure to EVD as the process evolves.
Process
1) Immediately following the initial donning process:
a) Once that Primary Clinical Staff Member is donned and about to enter patient room, the
Suit Buddy and 3rd
“stand by” staff member must “lay out” or prepare a full level 1 or
level 2 PPE for each of them in a location that enables quick access.
i) This location should be coordinated with the Trained Observer.
b) Suit Buddy and Trained Observer will verify the presence of a Backboard and trauma
scissors in the anteroom/hallway.
2) If Rapid Extrication is needed:
a) The Trained Observer (or designee) will immediately notify Incident Command/ Code
Team Activation
i) All arriving staff members must remain in the clean zone and the patient will be
brought to them “clean” before initiating patient care.
ii) A determination should be made if more than two staff members are needed in this
situation based on presentation of the scene, suspected injury and body type/ weight
of the injured staff member
iii) Call the ED for more trained personnel who can don PPE.
iv) Call for other trained 8m staff if located nearby.
v) The Trained Observer will notify the 3rd
“stand-by” RN to begin donning Level 1
PPE with the help of the Suit Buddy already in Level 3 PPE.
3) Once the 3rd “stand-by” RN staff member is donned and in the patient room.
a) This person would bring the “mega mover” transport sheet as needed.
b) Perform an initial assessment of the Injured Person.
c) Communicate any needs to the Trained Observer.
d) (if needed) Instruct patient to not participate in this process. Have them stay on the bed.
e) No clinical interventions should be performed on the Injured Person while inside the hot
zone. Even life saving procedures must be performed outside the patient room.
f) Tear away or cut the Trauma Gown from the Injured Person and dispose of it inside
patient room per normal process.
4) While the 3rd “stand-by” RN staff is assessing the situation/just entered the room:
a) The Suit buddy will then begin doffing the level 3 PPE
b) Once doffed that individual must immediately begin donning the level 1 PPE with the
assistance of the Trained Observer (or available trained designee)
c) Once in Level 1 PPE they should enter the patient room and prop open the outer door to
the anteroom as well as patient’s room door to increase ease of extrication.
5) Once an initial assessment has been made and doors are open:
a) Both the 3rd “stand-by” RN Staff member and the Suit Buddy (both in level 1 PPE) will
determine the best method to move the Primary Clinical Staff Member/Injured Person
and communicate that to the Trained Observer using the “mega mover” transport sheet if
possible.
i) If the Primary Clinical Staff Member /Injured Person can walk with assistance have
them assume a supine position once out of the patient room and in the warm
zone/anteroom.
ii) If unable to ambulate
(1) Remove trauma gown: rolling it slowly away from injured person.
(2) Use a log roll to position injured person on to “mega mover” transport sheet
(3) Identify and wipe any gross contamination prior to moving.
b) The patient’s room door in between warm/hot zone will be closed once staff have moved
injured person in to the anteroom.
i) Leave door to clean zone open to facilitate passing of equipment such as the
backboard, collar.
c) If the Injured Person is medically compromised where immediate removal of PPE is
recommend in the safest manner possible
i) The injured person’s Level 1 PPE will be completely wiped with Clorox wipes if any
gross contamination noticed
ii) If at any point in this process a need arises to wipe down the outer gloves both the
Suit Buddy and the 3rd “stand-by” RN will do so per normal procedures.
iii) Use trauma scissors to cut the level 1 PPE off taking care not to create a higher risk
of exposure for the Injured Person.
(1) Slowly roll the suit away from the injured person as it is cut.
(2) Once cutting is completed place trauma scissors in safe location in order to avoid
puncturing anyone’s PPE
d) Once out of PPE the Injured Person should be placed on a backboard with C-collar as
needed
e) The code team/ED personnel or 8m staff will pull the head backboard from the warm
area to the clean area once the injured person has been secured.
i) Staff in PPE will place the backboard at the edge of the warm/clean zone in order to
help this process.
ii) Under no circumstances would anyone in not in appropriate PPE enter the warm zone
f) The injured person would be transferred to ED for further evaluation as needed using
standard contact precautions per hospital policy.
6) Once injured the Injured Person has been removed from 8m:
a) Doffing will occur for the 3rd “stand-by” RN and Suit buddy utilizing additional
personnel to assist them.
b) The anteroom is to be no longer considered the warm zone; instead it should be treated as
a hot zone until a risk assessment can be completed by Environmental Health and Safety
and/or Infection Control.
c) Primary coordination and reporting of this unusual circumstance will be the responsibility
of the Trained Observer working with Employee Health, the ED and Incident Command.
d) An employee injury report should be completed and the EVD log should be noted as soon
as practical but before the end of the Trained Observers’ shift.
7) Rapid Extrication/ Emergent Move Concepts for Safe Operations:
a) Body Mechanics/Lifting Techniques
i) Safety precautions
(1) Use legs, not back, to lift.
(2) Keep weight as close to body as possible.
(3) Guidelines for lifting
(4) Consider weight of patient and the need for help.
(5) Know your physical ability and limitations.
(6) Lift without twisting.
(7) Have feet positioned properly.
(8) Communicate clearly and frequently with partner
ii) The greatest danger in moving a patient quickly is the possibility of aggravating a
spine injury.
iii) Every effort should be made to pull the patient in the direction of the long axis of the
body to provide as much protection to the spine as possible.
“ Mega Mover”
Log Roll *** Pictures do not represent acceptable PPE during this process
EVD Procedure
Procedure Issue Date: 2/16/15 Applies to: Downtown
Last Revision Date: 2/26/15
Last Review Date: 2/26/15
Downtown Emergency Dept. EVD Operations
Procedure:
1) Identify if patient is possible case using triage questions per NYSDOH order 10/16/14:
2) Patient Placement:
a) Have patient don a surgical mask immediately
b) Place patient in room A2 if available. (If occupied, place patient in triage 3 and make A2
available immediately for this patient.) Negative Pressure Required
c) Notify Charge Nurse, ED attending and Administrative Supervisor
d) ED Attending will confirm patient meets PUI status, involving Hospital Epidemiologist
as needed. (See EVD Notifications listing section above).
e) Incident Command will be activated by Administrative Supervisor
f) Retrieve EBOLA PPE from side room in Trauma 1
g) Designate PPE “suit buddy” and Trained Observer from trained staff to assist in the
donning and doffing
h) EVS Set up CAT A waste barrel in room 2261
i) Ensure that only trained EVD PPE personnel are engaged in the care surrounding this
patient. If needed contact Administrative Supervisor for additional trained staff.
3) If suspected patient is transported by local EMS
a) ED clinical or registration staff (whoever makes initial contact) will question the patient
presenting for care even if the transporting EMS agency has asked the questions indicated
in the NSDOH Commissioners order of 10/16/2014.
b) If the patient is incapacitated or presents with altered mental status -the transporting EMS
agency will be questioned in order gain the most amount of information if possible.
4) Care of this patient:
i) All Health Care Workers will use LEVEL 1 or LEVEL 2 PPE without exception.
(1) Suit Buddies would use Level 3
ii) A1 will be identified as room for donning and doffing PPE
iii) Security will secure area surrounding A1/A2/radio room allowing no foot traffic.
iv) If possible place privacy screens around A1/A2 area to increase privacy for staff
donning and doffing as well as the patient.
v) Maintain log of those entering A1/A2 area (see ipage for EVD contact log)
vi) NO VISITORS ARE ALLOWED TO ENTER THE PATIENT ROOM
5) SEE APPENDIX for Decontamination Zone Diagrams for A1/A2
6) A1/A2 Preparations
a) A1:
i) Remove stretcher and any other items not needed for donning and doffing.
ii) Place a bedside table in room for removal of PAPR
iii) Assure large bleach wipes are in room.
iv) Place blue mat on floor.
v) Place chair with arms in room.
vi) Bring dynamap into room.
vii) Assure red bag (meeting ASTM 1922 and ASTM1709 standards for 480 grams tear
resistance and 165 grams of impact resistance.) s are in cans and extra are in room.
viii) Obtain waste drum from EVS and place in room.
ix) Call HVAC to lower temperature in both rooms if clinically acceptable to do so.
b) A2:
i) Assure red bag (meeting ASTM 1922 and ASTM1709 standards for 480 grams tear
resistance and 165 grams of impact resistance.) are in room.
ii) Assure large bleach wipes are in room.
iii) Scan room for patient care items needed.
iv) Assure phone is in working order.
7) Management of Equipment & Bodily Fluids in and out of room:
a) ISTAT and all other equipment (i.e. disposable thermometer) used in room will remain in
room A1 or A2 as needed until a full decontamination is completed.
b) Labs: (See Highly Infectious Phlebotomy Protocol section below).
i) Limited to essential labs
c) Specimens transported in secure container by Microbiology personnel
d) Xray only when critical. If used, portable x-ray will remain in restricted area and not
return to general use.
e) EVS will manage the process for disposal of waste
f) All equipment and waste/trash must stay in room until appropriate EVS support is
available to assist in removing the waste in approved containers in PPE. (see waste
transport procedure)
g) Cleaning of ED waiting room begins ASAP, EVS staff will don Level 1 PPE.
8) Plan for Admission:
i) Transfer to 8M to be coordinated by Incident Command (See: Transfer Procedure)
EVD Procedure
Procedure Issue Date: 2/16/15 Applies to: Downtown
Last Revision Date: 2/16/15
Last Review Date: 2/16/15
8M Unit EVD Operations
Procedure: 8m, the designated EVD unit, has developed a functional team from nursing,
physicians and specialty services in order to provide the highest quality patient care under
this type of dynamic environment. Only trained and identified Upstate personnel will be
allowed to care for an EVD patient on 8m in order to minimize the number of staff
potentially exposed.
8M Opening Process:
Purpose: to identify specific action steps for staff in order to make ready the unit ready to accept
a patient.
1. Administrative supervisor is notified a patient is being sent to the Emergency dept. or
directly admitted to 8M.
2. Administrative supervisor calls the Hospital Administrator or Nursing Director on
call, security, and housekeeping.
3. *Incident Command is activated*
4. Administrative Supervisor will trigger the Everbridge Alert system to notify RN/MD
volunteers and other personnel (Emergency Preparedness, 8M manager, and
Environmental Health and Safety).
5. Administrative Supervisor will identify 4 RNs to send to 8M to open unit. (Check for
any current in house Ebola trained RNs).
6. Obtain key from key box on 8M to unlock equipment cart.
7. Remove training equipment from room 1 (8132).
8. Call environmental services to clean room. Environmental services will also set up
barrels, supply red bags, twist ties, and bleach wipes for unit.
9. Call pharmacy for stock medications (Narcotics and override meds).
10. Obtain Istat machine and supplies from 6th
floor (If not in use with patient in ED).
11. Bring swat monitor to 8M.
12. Confirm eye wash station is functional
8m Activation Checklist
Purpose: to identify specific action steps for staff in order to make ready the unit ready to accept a
patient.
1) Identify Staff Roles for those who are present:
a) Team leader to coordinate all efforts pre arrival
b) 2 (Level 1) PPE trained 8m clinical staff members to participate in EMS hand off on the 4th floor
c) 2 (Level 3) PPE Trained 8m staff members to assist as suit buddies
d) 2 (Level 1) PPE trained 8m clinical staff members to wait on the unit to assume patient care after
the patient has arrived on the unit
e) One Trained Observer (EHS, IC)
f) Request Environmental services personnel report to 8m to assist in general cleaning
g) Nursing Supervisor or 8M Manager to unlock supply carts in unit and Linen Room on 8B
2) START EMPLOYEE MONITORING PAPERWORK FOR ALL STAFF WHO DON PPE.
a) Work with incident command on the proper reporting of those documents after patient has
arrived.
b)
3) Verify the notification of the following thru the Admin Super
a) UPD
b) Environmental Services
c) Lab
d) Physicians who are trained on 8m PPE
e) OTD personnel to begin just in time training of other identified clinical staff (physicians, etc.)
that may not be current.
f) Pharmacy
g) Nurse Manger of 8M unit
4) Patient Room Area
a) Remove
i) mannequin to ergonomics room (or off unit)
ii) Throw out IV training supplies currently connected to pump
iii) Empty Sharps containers of training items/Obtain new sharps containers
iv) Empty Trash Cans of training waste (ensure training waste in clear NOT red bags and off the
unit prior to patient arrival)
b) Change bed linen and pillow
c) Turn all Lights on
d) Verify operational status and location:
i) IV pump
ii) O2
iii) Monitor
iv) Monitor cables
v) containers of bleach wipes are in holders
vi) Mulltiple zip ties next to door
vii) Lab specimen container
viii) Suction unit
ix) Ambu bag
x) Verify clean up/spill kit is near room
xi) Verify TV works (do not leave on)
xii) Call bell
xiii) Bedside Table
e) Obtain
i) Portable blood pressure cuff- Float Office
ii) digital stethoscope
iii) Med Box
iv) Istat
v) central line kit, foley, barrier cart, ultra sound machine
vi) Thermometer
vii) Several bed pans /urine jug
viii) Commode (to be placed in supply room)
ix) Obtain liquid bleach for bathroom in pt room
x) Fill latex glove rack in pt room
xi) Egg timer for dwell time.
5) 2ndary patient room
a) Remove ventilator unless clinically needed
b) Decide placement of crash cart (in hall or in 2ndary patient room) based on clinical needs
c) Verify presence of swiffer sweeper
d) Verify operation of pass thru to lab
6) Ante Room/ Doffing area
a) Verify the following are in good supply in the cabinets located in the anteroom
i) Egg timer
ii) Multiple Blue sheets
iii) Red bags
iv) Bleach wipes
v) Gloves (all sizes)
vi) Extra bottles of solidifier
b) Ensure the following are in the room or obtain.
i) Folding chair
ii) Bedside Table
iii) Garbage can (remove training waste similar to patient room)
iv) Hand soap in dispenser
v) Trauma scissors are on wall
7) Nurses Station
a) Remove
i) Training PAPR Hoods & Filters from unit (throw away)
ii) All training or unit trash (non medical waste) prior to patient arrival
b) Verify operational status and location:
i) Audio and video system
(1) Sign in to camera system (use AV binder for instructions)
ii) Desktop computer/EPIC system
(1) Sign in as needed
iii) code cart is present
iv) Zoll operational
v) Phillips Intellevue MP 50
vi) Scale for clinical staff use pre and post donning and doffing near RN station
c) Obtain
i) Ensure new PAPR hoods and filters are placed on the donning table
ii) Ensure new Tychem level 1 suits are placed on the donning table
iii) key for Pharmacy box
iv) portable blood pressure cuff for donning pre-checks of clinical staff
v) Linen key
vi) Supply closet door code is (*****)
vii) patient chart as needed
viii) Create patient bracelet, labels, welcome folder/booklet.
d) Contact pharmacy
i) order antiemetic, anti diharria as well as pain meds per clinical needs
ii) order electrolytes fluids on standby
iii) Order rehydration fluids for patient to drink if able.
8) Other items
a) Order additional linen for unit as well as a schedule of fresh linen for regular delivery
b) Open Family Room
c) Contact Incident Command
i) Obtain cell phone for patient use if needed
ii) Laptop for patient use if needed
d) Verfiy Eyewash is operational
e) Personnel on 8m need to be kept to a minimum. Utilize UPD for help controlling this
f) When patient is approaching 8m during EMS transfer ALL personnel not in LEVEL 1 PPE MUST BE
OFF THE UNIT until deemed safe and the patient is in the designated room on 8m
g) Obtain
i) Portable blood pressure cuff- Float Office
ii) digital stethoscope
iii) Med Box
iv) Istat
v) central line kit, foley, barrier cart, ultra sound machine
vi) Thermometer
vii) Several bed pans /urine jug
viii) Commode (to be placed in supply room)
ix) Obtain liquid bleach for bathroom in pt room
x) Fill latex glove rack in pt room
xi) Egg timer for dwell time.
9) 2ndary patient room
a) Remove ventilator unless clinically needed
b) Decide placement of crash cart (in hall or in 2ndary patient room) based on clinical
needs
c) Verify presence of swiffer sweeper
d) Verify operation of pass thru to lab
10) Ante Room/ Doffing area
a) Verify the following are in good supply in the cabinets located in the anteroom
i) Egg timer
ii) Multiple Blue sheets
iii) Red bags
iv) Bleach wipes
v) Gloves (all sizes)
vi) Extra bottles of solidifier
b) Ensure the following are in the room or obtain.
i) Folding chair
ii) Bedside Table
iii) Garbage can (remove training waste similar to patient room)
iv) Hand soap in dispenser
v) Trauma scissors are on wall
43
11) Nurses Station
a) Remove
i) Training PAPR Hoods & Filters from unit (throw away)
ii) All training or unit trash (non medical waste) prior to patient arrival
b) Verify operational status and location:
i) Audio and video system
(1) Sign in to camera system (use AV binder for instructions)
ii) Desktop computer/EPIC system
(1) Sign in as needed
iii) code cart is present
iv) Zoll operational
v) Phillips Intellevue MP 50
vi) Scale for clinical staff use pre and post donning and doffing near RN station
c) Obtain
i) Ensure new PAPR hoods and filters are placed on the donning table
ii) Ensure new Tychem level 1 suits are placed on the donning table
iii) key for Pharmacy box
iv) portable blood pressure cuff for donning pre-checks of clinical staff
v) Linen key
vi) Supply closet door code is (*****)
vii) patient chart as needed
viii) Create patient bracelet, labels, welcome folder/booklet.
d) Contact pharmacy
i) order antiemetic, anti diharria as well as pain meds per clinical needs
ii) order electrolytes fluids on standby
iii) Order rehydration fluids for patient to drink if able.
12) Other items
a) Order additional linen for unit as well as a schedule of fresh linen for regular delivery
b) Open Family Room
c) Contact Incident Command
i) Obtain cell phone for patient use if needed
ii) Laptop for patient use if needed
d) Verfiy Eyewash is operational
e) Personnel on 8m need to be kept to a minimum. Utilize UPD for help controlling this
f) When patient is approaching 8m during EMS transfer ALL personnel not in LEVEL 1 PPE MUST BE
OFF THE UNIT until deemed safe and the patient is in the designated room on 8m
8M Staff Primary Evaluation and Feedback Process: 1) Evaluation of team members is achieved through direct observation during full scale exercises and various drills
conducted every month.
2) Topics for these exercises includes clinical skills while in PPE and staff must demonstrate competency on infection
control practices, policies, and procedures while for caring for a patient with Ebola
3) Any remediation of procedures or PPE usage is done immediately with continued performance improvements corrected
as the nursing manager, safety officer or drill coordinator as they see fit at the time of the drill.
4) At the conclusion of each drill or exercise feedback is requested from those staff members participating as a
methodology for process improvement in Upstate’s EVD preparedness globally.
a) Feedback items are tracked by Emergency Management and/or Infection Control using the normal reporting process
to the Upstate Safety Committee.
5) Representatives from Employee health and/or Human Resources will be made available to speak with all
Upstate personnel who directly care for or support the care of an EVD patient in order to answer any
questions they may have.
8M Clinical Staffing Process 1) All volunteer clinical staff members who participate in the care of a diagnosed EVD patient will be
reassigned from their areas to 8m for the duration of the patient’s stay at Upstate.
2) The 8m Unit Director and Administrative Supervisor shall ensure 24/7 coverage across all shifts for appropriate on-site
available staff members to immediately report to 8m if a possible EVD patient is sent to Upstate.
a) Staffing numbers will be validated monthly using existing schedules and identifying trained staff members
availability.
3) If an EVD patient arrives
4) The 8m Unit Director and/or Administrative Supervisor shall initiate a “RED ALERT” call to all designated and trained
staff members to report to 8m immediately.
5) 8m will operate on either 8 hour or 12 hour shifts with a minimum of 4 nurses and 1 physician in the department at all
times.
6) Daily Clinical Meetings will be held twice a day in order to coordinate care in 8m as well as to ensure that a minimum
number of staff is needed in the warm zone. (see section below)
7) Maximum duration that staff will be allowed in PPE will be determined in these meetings based on clinical needs as
well as the number of staff available. Every effort shall be made to keep the amount of time in PPE to a minimum
amount.
8) Staff will be instructed to rest/recover in the staff lounge in between durations of time spent in PPE or supporting those
in PPE. Minimum timeframe for rest will be determined by the staff member involved and the Trained Observer on site
at the time.
Protecting Patient information 1) All Upstate suspected of diagnosed EVD patients will be made a “Private Encounter or Alias” per policy A-
12 as soon as possible.
2) The patient must be informed that 8m unit closed circuit cameras/intercom will be used to monitor and
record actions of clinical staff in addition assisting clinical assessments for specialists who cannot enter the
room. All saved tapes will become part of the medical record.
Daily Clinical Meetings 1) At least twice a day with Physicians, Nursing, Environmental Services, and Safety/Trained Observers &
Laboratory personnel will meet on 8m to discuss the clinical goals, logistics and any safety related issues
regarding the current care of the EVD patient.
a) The goal of this meeting is to
i) Coordinate all clinical care and testing to ensure the smallest number of procedures and staff
required to enter the patient room.
ii) Coordinate waste management and transfer.
b) These meeting will be a method to communicate any information received from the CDC and NYSDOH
regarding this EVD patient
i) Other items that should be discussed
(1) Special equipment needed
(a) Staging, use and process needed to use the equipment (example: X-ray) and
decontamination/storage in patient room if required ( completing equipment log)
(b) Specifically identify how something is to be cleaned and by whom if necessary
(2) Clinical Consultations required
(3) Staffing needs
(4) Patient needs
(5) Other safety topics as needed.
Property Management for a diagnosed EVD Patient 1) All property that a suspected EVD patient brings with him/her into the facility will go into room with
patient or in room #2 (in the warm zone) located on 8m.
2) All property will be checked in using form #f83584 by RN on 8m.
3) Subsequent to treating a confirmed EVD Patient, all property in the room will be treated as waste and will
be discarded in accordance with Upstate’s waste disposal procedure.
8m Security Coordination 1) 8m will be considered a restricted access space within Upstate Hospital
2) The north door to 8m will remain on key card access throughout the patient’s stay
3) The south door to 8m will remain an emergency exit only door.
4) Access to the space on 8m will be coordinated between Incident Command, University Police and 8m Unit Director on
an as needed basis.
5) Most consulting clinicians will need to be escorted in to the 8m clean zone and would not need continuous key card
access.
6) Ensuring the general public and news media remain away from that space will remain a top priority. Any changes in
securing that area should be communicated to other departments located on the 8th
floor as well as 8m staff by UPD or
Incident Command as needed.
8M unit access 1) The 8M “Ebola” Unit is a secured unit from the outside to prevent unauthorized access. There are both
North and South exit doors leading from the unit that are fully accessible from the inside at all times in the
event of an emergency.
2) The North exit door is labeled “Authorized Personnel Only” and is accessible to authorized personnel via ID
card swipe. The ID card swipe is maintained by the 8M Unit Director or designees.
3) The South exit door is labeled “This is not an entrance. “Emergency Exit Only”.
4) Both exit doors are off of the hospital master key with the following personnel as key holders: 8M Unit
Director, Environmental Health and Safety Department, University Police and Administrative Supervisor.
5) Room 8133, designated a patient ant-room, is fitted with a key lock located on the corridor side of the door.
6) The intent of the lock is to provide the ability to secure access to and from the patient room when the room
is actively being used during treatment of a suspected or known Ebola patient.
7) The use of the key is strictly controlled and is intended to be used only as conditions warrant while a patient
is actively being treated on 8M. The key will be secured in a key lock box operated by a key code located
adjacent to the nurses’ station at all other times.
8) The key shall only be used at the direction of Hospital Incident Command, as necessary, to mitigate
unauthorized entry or exit to the patient room. (i.e. wandering patient, visitor control) The following
procedures shall be followed while the patient room key is in use:
a) One nurse shall be present outside of room 8133 at all times and in possession of the key for room 8133
while the patient room door is locked.
b) A spare key for room 8133 shall be maintained in the key lock box adjacent to the nurses’ station.
c) When the lock is in use and access to the patient room is required the nurse shall unlock the door and
place all keys back in the key lock box to prevent accidental re-locking of the door.
Visitors 1) Visitors who have been in contact with EVD patients before and during hospitalization are possible source
of EVD for others.
2) Visitors cannot enter into a patient’s room.
3) Evaluate exceptions on a case-by-case basis with Incident Command and take in to consideration pediatric
patients need to stay near parents.
4) Consult Onondaga County/ NYSDOH for management of visitors on premises
5) Assist with Onondaga County/ NYSDOH as they begin a patient history investigation to identify other
people the patient may have had extended contact with.
Upstate 8m Consultation & Intercom Use
1) Use of the 8m intercom and video monitoring system will be used in conjunction with phones to minimize
the number of clinical providers and support staff members who would need to enter the warm zone.
2) The non-inclusive list below are some of the team members who would use the intercom systems on 8m to
communicate with the patient or primary care staff members in Level 1 or 2 PPE.
a) Infectious Diseases physician
b) Nephrologist
c) Nutritionist(s)
d) Physical/occupational therapist(s)
e) Family Support Staff
f) Mental Health Specialists
g) Pallaitive Care
h) Chaplain
i) Interpretive Services
j) Other Ancillary services providers as needed.
EVD Procedure
Procedure Issue Date: 2/16/15 Applies to: Downtown
Last Revision Date: 2/16/15
Last Review Date: 2/16/15
EVD Equipment Log
Procedure: This log must be completed by the Trained Observer (or designee) every time piece of clinical
equipment is used in the care of an EVD patient. (Printed Copies of this log are located at the 8M nursing
station) This log must be kept on file in 8m with copies sent to Incident Command as requested.
Equipment log 8m EVD
Date
used
Equipment
Name/type
ID # or
serial
number
Did
equipment
enter the
warm
zone?
(circle
one)
Can
equipment
be cleaned
for reuse
by EVD
patient?
(circle
one)
Cleaning/Decon
process
identified &
reviewed with
Trained
observer?
Cleaning/Decon
completed?
(circle one only
if it can be
cleaned for
reuse for EVD
patient)
Date
Cleaned
Name
of
cleaner
Notes:
1 Y / N Y / N Y / N Y / N
2 Y / N Y / N Y / N Y / N
3 Y / N Y / N Y / N Y / N
4 Y / N Y / N Y / N Y / N
5 Y / N Y / N Y / N Y / N
** equipment log only need for types of equipment normally not designed as "single use" or "disposable" but attempt to record as much as possible during the care
of an EVD patient
*** all equipment used in the care of an EVD patient must not be returned to normal circulation in the hospital even after a cleaning has been
performed
EVD Procedure
Procedure Issue Date: 2/16/15 Applies to: Downtown
Last Revision Date: 2/26/15
Last Review Date: 2/26/15
Nursing Specimen Collection /ISTAT 8m
1) General Points and Safety
a) iSTAT should only be used if POC lab on 8m Pass thru portal is non operational.
b) Limit testing to those tests performed using the iSTAT device
c) iSTAT machine should be placed in the Anteroom in between use
i) The iSTAT machine will remain in the anteroom and cannot be used for any other patient.
ii) If laboratory-based testing is required, every effort will be made to coordinate submission of
specimens during the Day Shift.
iii) All personnel involved in specimen handling will use required PPE provided in the EVD kit.
d) Limit testing to only essential labs.
i) If possible, fix a time table for collection of specimens
ii) Limit the use of needles and other sharps as much as possible
iii) Phlebotomy and laboratory testing should be limited to the minimum necessary for essential
diagnostic evaluation and medical care
iv) For patients with suspected EVD, collect the following samples via a single venipuncture using a
butterfly/vacutainer set. Fill out down-time requisition pre-completed for Ebola PCR, malaria PCR,
and malaria antigen. Fill out NYS Infectious Disease requisition.
v) 3 EDTA (lavender top) tubes
e) Needles and sharps should be handled with extreme care and disposed in properly labeled puncture-
proof, sealed containers
2) 8m iSTAT quick tips
b) Below are a basic list of tests available on each POC or Lab device:
c) All EVD patient testing will be coordinated and reduced to an absolute minimum
d) iSTATs:
i) blood gas, lactate, hgb/hct, Chem 8 (Na, K, CL, CO2, Bun, Creat, Ca, Glucose), troponin I
e) Piccolo:
i) Albumin, ALP, ALT, Amylase, AST, Total Bilirubin, Bun, Calcium, Creat, Glucose, GGT, Total
Protein, Uric Acid , Na, K, CL, Co2, Mg, Phos
EVD Procedure
Procedure Issue Date: 2/16/15 Applies to: Downtown
Last Revision Date: 2/16/15
Last Review Date: 2/16/15
EVD Patient Discharge Process
Procedure:
1) Prior to the Patient’s discharge
i. Family member/friend will be asked to bring clean clothing to the hospital
ii. These clothes will be placed in a clean shower room on 8B
2) On the day of discharge
i. Nursing staff will explain this procedure to patient. Reviewing the use of trained observers and suit
buddies.
3) In the Patient Room
i. Clean scrubs and sock/slippers will be placed in sealed bag in patient’s room
ii. Patient will be reminded that they may take nothing with them out of the room. (example: personnel cell
phone)
iii. Patient takes a shower inside their room.
iv. After shower, patient will stand on clean towel in bathroom and after drying puts on clean scrubs &
socks/slippers
v. Patient dons Level 3 boot covers over sock/slippers
vi. Patient dons 1 pair of gloves
vii. Patient will step to their room door and open it using bleach wipe.
viii. Patient will then begin doffing procedures as read by Trained Observer with help from Buddy.
4) In the Warm Zone
i. Patient will use a bleach wipe to clean gloves – allow for dwell time then remove gloves. Patient will then
put on another pair of clean gloves
ii. Patient will sit on stool and carefully remove one boot cover and sock and discarding them into
regulated medical waste container
iii. Patient will then don clean sock and without placing their foot in the warm zone puts clean foot into the
cold zone
iv. Patient will carefully remove second boot cover and sock and repeat process for second foot.
5) While standing in the Cold Zone
i. Patient will carefully stand in cold zone, doffs gloves and cleans hands with alcohol
ii. Patient walks to the room designated in 8B to dress in personal clothes after showering a second time.
B. Coordinate with Incident Command and Environmental Services regarding the terminal cleaning of
patient areas on 8m.
EVD Procedure
Procedure Issue Date: 2/16/15 Applies to: Downtown
Last Revision Date: 2/16/15
Last Review Date: 2/16/15
Exposure Management
Procedure:
1) Known or suspected percutaneous or mucus membrane exposures to blood, body fluids, secretions, or
excretions from a patient with suspected EVD.
2) Each and every employee who donns PPE during the care/treatment or support of an EVD patient will
complete the Upstate EVD Contact Log and Upstate Employee Medical Monitoring sheet prior to wearing
any level of PPE.
3) Employees are encouraged to report illnesses prior to donning and after doffing each shift by the suit buddy
and the trained observer. All employees are reminded to report illness or injury to supervisors or employee
health per normal policy.
4) Once created this log will be entered in the HCS (Health Commerce System) after each shift
5) Employee health working with Upstate’s Infection Control & Onondaga Dept of Health, will initiate a
system of health checks while providing care and support to an EVD patient at Upstate. These checks will
continue for an additional 21 days after the last exposure to an EVD patient.
6) IMMEDIATELY
a) Wash contacted skin surfaces with soap and water
b) Irrigate mucus membranes (e.g., conjunctiva) with copious amounts of water or eye wash solution
c) Complete an Injury Report Form
d) Reporting Exposure proceed without delay
e) Downtown Campus: Call Employee Student Health (ESH) at 464-4260 on weekdays between 7:30 AM
- 5 PM.
f) Both campuses: After hours, weekends and holidays, notify supervisor and request to leave work.
Report to ED per policy for evaluation for Blood and Body Fluid Exposures. For questions regarding
EVD: ED physician will contact Hospital Epidemiologist. Notify EH of exposure by leaving message at
above numbers.
7) EH informs Infection Control upon notification of exposure
8) Monitoring asymptomatic HCP for illness
9) Documentation of current health status (complete medical questionnaire)
10) Monitor and record body temperature twice daily for 21 days after exposure
11) Twice Daily communication with EH to report:
a) See Employee/Student Health Appendix C
12) Asymptomatic HCP may continue to work with twice daily fever checks and symptom monitoring
depending on NYSDOH and CDC recommendations as interpreted by the Hospital Epidemiologist.
13) If an Upstate Employee is quarantined by a public health officer (such as the County Health Dept., NYS
Health Dept., CDC etc.), the New York State Time & Attendance Rules provide a means for State
employees to remain in a full-pay status during the quarantine period. If there is an on-the-job high risk
exposure, or if an employee exposed at work becomes symptomatic with a confirmed Ebola diagnosis, a
workers’ comp claim will be initiated to provide income replacement and payment of eligible related
medical expenses.
14) Symptomatic Employee
a) Do not report to work – communicate medical status to employee health
b) If currently at work immediately notify your supervisor after isolating yourself as much as possible.
c) Comply with work exclusion per Public Health Officials until deemed no longer infectious to others
EVD Procedure
Procedure Issue Date: 2/16/15 Applies to: Downtown
Last Revision Date: 2/16/15
Last Review Date: 2/16/15
Employee Monitoring Process
Number of Staff Needed: Infection Control and Employee Health personnel working with the trained
observer on 8m
Equipment: CDESS Access for IC and Employee Health
1) Definition:
A. Healthcare workers providing care to Ebola patients in U.S. facilities while wearing appropriate PPE and
with no known breaches in infection control are considered to have low (but not zero) risk of exposure
considering unrecognized breaches PPE
B. All Upstate employees who wear PPE for the care or support of an EVD patient will be monitored as
indicated in this document
2) Procedure
1. Each identified employee will do twice daily temperature checks and symptom evaluation
i. While actively engaged in Ebola patient care and related cleaning duties and for an additional 21
days after the last date of contact
ii. Temperature monitoring will be completed by body temperature measurement using an oral
thermometer , which will be provided
2. EVD patient contact documentation
a. Employees with EVD patient contact must complete the EVD Contact Log (on the Upstate Ipage)
ii. Safety Officer monitors for proper completion each shift
iii. Safety officer (or designee) enters all EVD Contact Log data HCS (Health Commerce System)
CDESS for future tracking (requires HCS & CDESS access)
iv. EVD Contact Log will be provided to Employee Health or Infection Control by 10 AM daily (may
be coordinated by Incident Command)
3. Daily Active Health Monitoring
A. Completed daily by every employee listed on the EVD Contact Log
B. Begins with the first contact and continues until 21 days after the last contact
1) Employee must call Employee Health (464-4260) before 9 AM and again before 7 PM
a. Choose the phone menu option specific to EVD monitoring.
b. Required information.
1) Time of call
2) Name
3) Employee ID number
4) Contact phone number
5) Body temperature (oral)
6) State any other symptoms associated with EVD such as vomiting, diarrhea or unexplained
bleeding or bruising
7) Express related health concerns or questions
ii. Employee Health or Infection Control will document employee self monitoring calls twice daily
iii. Changes in health prior to normal telephone reporting time
a. Immediately contact Employee Health and speak directly with clinical staff member between
8AM – 5 PM weekdays (do not leave a message)
b. During Employee Health off-hours, call the Upstate operator and ask to speak with the on-call
Infectious Disease attending
c. Do not report to work or travel
d. Isolate yourself in a separate room with its own bathroom if possible while using a cell phone to
communicate
e. Further direction will be provided by the Hospital Epidemiologist
iv. Failure to report
1) Employee Health will notify Onondaga County Department of Health within 24 hours of the last
missed call.
4. Employee Health Active Monitoring Process:
A. Ensure the EVD Contact Log is being properly completed every shift
1) Documentation includes name, date of birth, contact information, location of work, time in and
out of care area or lab, specific tasks and type of exposure, infection control breach (if any), type
of PPE worn, donning/doffing and patient care observation, etc. (See attached EVD Personnel
log.)
ii. EVD Contact Log shall be provided to Department of Health at agreed upon intervals. (should be
coordinated through Upstate Incident Command)
iii. Upstate Incident Command will request CDESS Trainers from NYSDOH to assist in the set up
and initial phases of the employee monitoring process.
iv. Additional administrative help can be coordinated by Upstate Incident Command.
i. HCS & CDESS access must be granted by NYSDOH. ( 1 day turn around)
v. Employee Health or Infection Control will review CDESS data daily for any indication of a
higher level of exposure. EVD exposure protocol will be initiated by the Director of Employee
Health.
EVD Procedure
Procedure Issue Date: 2/16/15 Applies to: Downtown
Last Revision Date: 2/16/15
Last Review Date: 2/16/15
Special Populations: Pediatrics/OBGYN
Procedure:
1) All patients will be screened per NYSDOH Commissioners order of 10/16/14 every time they present for
care.
a) Coordination and Communication with the care of these types of patients is critical.
b) Contact NYSDOH and Onondaga County Dept of Health immediately.
2) Pregnant Patients:
a) Any suspect EVD patient that presents for care and answer the screening questions with a high degree of
suspicion necessary clinical specialists would be moved from the Upstate Community Campus to the
Downtown Campus immediately in order to provide the appropriate level of care.
b) If a pregnant patient with suspected EVD and concern for imminent delivery presents to the ED, the
patient will be assessed by the ED physician and appropriate measures for emergent delivery will be
undertaken while maintaining established EVD precautions, If a pregnant patient presents without
obstetrical complaints but meets concern for EVD, standard ED EVD care will be followed.
c) This should be the last option.
3) Pediatrics
a) Pediatric EVD patients will not be cared for in the Ebola unit
b) ED physicians and pediatric ED nurses will provide immediate care in the Emergency Department
c) NYSDOH should be contacted immediately in order to assess another pediatrics facility with more
resources and plan for transfer of patient
4) Parents/Caregivers
a) A safety briefing will be given by identified clinical care staff to review the following with the parents
i) Parents/caregiver should wear appropriate PPE when in the patient care room at all times (Training
will be provided as soon as possible)
ii) Consult with legal department/NYSDOH if Parent/Caregiver refuses such PPE
iii) Such a refusal must be documented and witnessed per Legal Department standards
It must be made clear to Parent/Caregiver that refusal to wear PPE would remove their ability to leave
the patient room at any time and could pose a threat to their own safety.
Ebola Medical Monitoring Worksheet
1. Filled out by all Upstate personnel who don PPE at any time during the course of an EVD patient’s care.
This form is to be used in conjunction with the EVD HCW contact log as both of these documents will be
given to Infection Control/Employee health at the end of each shift.
(This form does not replace the need to fill out EVD Monitoring Spreadsheet) Employee Name: ___________________________________________ Date: __________
Trained Observer: ______________________ Buddy: ______________________
Donning of personal protective equipment may be denied to any person with the following vitals
o Temperature > 37.3,
o Respiration > 24,
o Pulse >110,
o Blood Pressure >150/90
You must monitor your own physical condition while in protective clothing. If you develop chest pain, shortness of breath, dizziness,
light-headedness, change in gait or behavior, you must leave the patient area immediately using good doffing procedures.
*****Early identification of any potential medical or physical issues is essential in maintaining your safety. Discuss any concerns
you may have with your suit buddy or trained observer prior to donning.
Pre-entry Data P
o
s
t
-
e
n
t
r
y
D
a
t
a
Time:_______________________
Vitals:
Temperature: ________
Pulse: ______________
Respirations: ________
BP: _____/____
Weight: ______
Vitals taken by:
_____________________________
Time:_______________________
Vitals:
Temperature: ________
Pulse: ______________
Respirations: ________
BP: _____/____
Weight: ______
Reassessment is needed write in below:
Vitals taken by:
_____________________________
Original to Employee/Student Health Services with Daily EVD Contact Log ---- Copy to be kept on 8M
Suit Sizing Information: N95:____
Gloves (outer):_____ Gloves (inner):_____ Tyvek Suit Size:_______
Cowel:_____ Clogs:____
58
Upstate HCW EVD Health Monitoring Log
59
EVD Procedure
Procedure Issue Date: 2/16/15 Applies to: Downtown
Last Revision Date: 2/16/15
Last Review Date: 2/16/15
Patient Transfer Protocol (Internal & External)
UH Downtown to another EVD Center
A. UH has been designated the region’s hospital for the care of EVD patients.
B. As such it would be a rare circumstance that UH would be transferring a patient to another
facility. Possible exceptions to this may be patient/family request or need for specialty care
not available at UH, e.g., Pediatrics or OBGYN
C. This circumstance would be so unusual as to render a prior transfer protocol with another
receiving hospital extremely difficult to arrange.
D. Upstate would seek NYSDOH guidance on determining receiving hospital.
E. These cases would follow standard EMTALA & UH policies.
NYSDOH EVD Center Distance
from SYR Est.
time
University of Rochester Medical Center in Rochester 89 miles 1.5
hours
Women and Children’s Hospital of Buffalo 150 miles 2 hours
Erie County Medical Center 146 miles 2hours
Bellevue in Manhattan 250 miles 4 hours
Montefiore in the Bronx 253 miles 4 hours
Mt. Sinai in Manhattan 254 Miles 4 hours
New York Presbyterian in Manhattan 250 miles 4 hours
North Shore Health System in Nassau County 267 Miled 4 hours
Stony Brook University Hospital on Long Island 300 miles 5 hours
** Estimated time assumes good weather. Taken from Google maps
Other Hospitals & Upstate Community Campus to Downtown Campus
1) Patients meeting threshold for EVD testing or optional testing as defined by NYSDOH
Commissioners order of 10/16/14 should be considered for transfer to UH-Downtown for
evaluation and/or care. (Patients that present to UH-CC ED will follow similar steps as the as
that Campus is not considered an EVD Treatment Hospital)
2) These patients will be transferred by Rural Metro with coordination with NYSDOH (See
Direct Admit Process/ EMS Integration)
Upstate Hospital EVD Guidance Downtown Campus Page 60 of 250
3) Pts must be transferred in biohazard coveralls (if patient is able to don this without
assistance) or an impervious sheet.
(1) The patient must wear a surgical mask unless clinical condition precludes.
(2) Paramedic personnel will follow their own agency’s EVD protocol otherwise.
4) Patients being transferred from other Hospitals will go directly to 8M and bypass the Upstate
ED.
Communications during Transfer
1) Transferring hospitals make a request for transfer via the UH Transfer Center (315 464
5449).
2) Per NYS directive the transferring hospital must have notified and discussed the case with
their local health department official.
3) The Transfer Center will contact UH Epidemiologist on call to discuss the case with the
transferring hospital physician.
4) UH will accept patients that meet threshold for EVD testing or optional testing as defined by
NYSDOH Decision Guide for Consultation and Ebola Virus Disease (EVD) Testing.
5) The Transfer Center will contact the UH Nursing Administrator on call and the ICU EVD
Attending on call to confirm bed placement and formalize patient acceptance, respectively.
6) These patients will be accepted directly 8M
7) Transporting EMS agency will be coordinated with Syracuse Rural Metro, Upstate and
NYSDOH
8) Patient must be transferred in biohazard coveralls (if patient is able to don this without
assistance) or an impervious sheet.
9) The patient must wear a surgical mask/ PPE “coverall” provided by EMS which is water
impervious unless clinical condition precludes.
10) Paramedic personnel will follow their own agency’s EVD protocol otherwise.
UH Outpatient Clinics to UH Downtown
1) Clinics will follow UH EVD Guidance Document.
2) Once identified, if able, clinic physician will contact appropriate campus epidemiologist to
discuss case and need for further evaluation.
3) Transport of the EVD pt will occur with cooperation of the Onondaga County 911 Center as
well as Rural Metro
Transport of EVD Patients from Downtown ED to Inpatient Room
1) Coordination should occur between the following prior to any movement
i. UPD
ii. 8m staff
iii. ED staff
iv. Environmental Services
v. Incident Command
2) Patient must be transferred in biohazard coveralls (if patient is able to don this without
assistance) or an impervious sheet. The patient must wear a surgical mask unless clinical
condition precludes
Upstate Hospital EVD Guidance Downtown Campus Page 61 of 250
3) Use of the Room 1 bed from 8M is preferred.
4) All equipment used in the transportation of an EVD patient must stay in the warm zone on
8m until decontaminated.
5) Nursing and ancillary transport staff will wear EVD PPE Level 1 or Level 2
6) Only Trained EVD PPE Staff are allowed to move the patient.
7) UH Security will secure hallways and reserve elevator.
i. Terminal cleaning of hallways will be coordinated through Environmental Services and
Incident Command.
ii. Any gross contamination will follow Waste Spill Protocol with consultation from
Environmental Health and Safety.
iii. All Environmental services personnel would don Level 2 PPE for this process.
Upstate Hospital EVD Guidance Downtown Campus Page 62 of 250
EVD Procedure
Procedure Issue Date: 2/16/15 Applies to: Downtown
Last Revision Date: 2/16/15
Last Review Date: 2/16/15
EVD Direct Admit/EMS Integration for 8M
Staff needed: 2 Rural Metro staff members, 4 8m RNs, 3 ED RN’s, Trained Observer, 3
Environmental Services, and 5 University Police/Security
Equipment Needed: 8m Bed, PPE Level 1, 2 & 3. Blue Mats,
Procedure:
1) 911 Center calls ED via radio or phone to notify EMS dispatch to a highly suspect EVD
patient.
a) ED attending or ED Charge would notify Administrative Supervisor immediately
2) The Administrative Supervisor would
a) trigger Red Alert: 8M General Alert and 8M Staffing Need Alert
b) Ensure all clinical staff report to 8m for initial briefing
c) Admin Supervisor should also report to 8m
d) Send someone from UPD or EVS to open up room 4760
e) Determine if ED or room 4760 is the best point of entrance for this highly suspect patient.
Upstate Hospital EVD Guidance Downtown Campus Page 63 of 250
i) Consider factors such as
ii) Patient clinical needs
iii) ED patient load
iv) Availability of staff to fulfill PPE roles
v) Activation time and current state of readiness for 8m
f) Immediately move nursing resources to support the ED
g) Contact manager of Surgical Specialties and other 4th
floor departments to warn them of
incoming patient as needed and if time allows. (UPD/Security can assist with this
h) Activate Incident Command/ Contact the Administrator on Call
i) Contact EHS person on call
j) Contact Environmental Services Supervisor on duty
k) University Police Dispatch
l) If facility to facility transfer coordinated with the assistance of NYSDOH the transporting
EMS agency would be directed to alternate entrance (room 4760) and avoid using the ED
all together.
m) Once on 8m all staff need to sign in to the EVD contact log.
3) 8M Preparations
a) Administrative Supervisor will identify 4 RNs to send to 8M
i) Check Kronos for any Ebola RN on call staff
ii) 2 staff members must change in to scrubs/shoe, grab their own appropriate sizes
for PPE out of the 8m stock and take the primary patient bed to transport patient from
room 4760.
b) Obtain keys from Administrative Supervisor (or 8m Nursing Director) to unlock
equipment carts
c) Call Environmental Services to clean room; make bed and place barrels, red bag (meeting
ASTM 1922 and ASTM1709 standards for 480 grams tear resistance and 165 grams of
impact resistance.) s, twist ties, bleach wipes as needed.
d) Call for any specialized equipment as needed.
e) Call Pharmacy for stock meds (narcotics and override meds)
f) Obtain iSTAT from 6th
floor room 6414 and supplies
g) Call 12F for U/S machine
h) Turn on video and intercom systems.
i) Once 8m staff has arrived
i) Initiate briefing for staff to review plan, assign roles.
ii) Immediately don PPE
LEVEL 1 or 2 PPE: Tychem full body suit with booties, N95/PAPR, Face Shield,
Cowl (hood), Outer Glove, 2 pair of Inner Gloves (Blue Nitrile), trauma gown.
iii) The other 2 staff member should stay in 8m to prep room
(1) LEVEL 1 or 2 PPE: Tychem full body suit with booties, N95/PAPR, Face Shield,
Cowl (hood), Outer Glove, 2 pair of Inner Gloves (Blue Nitrile), trauma gown.
iv) Bring patient bed and PPE to 4760 for donning as well as an emisis bucket.
4) Initial ED responsibilities
a) Immediately designate 3 trained staff members to report to room 4760 to operate as Suit
Buddies for 8m staff as well as assistants for EMS crew doffing and waste disposal.
Upstate Hospital EVD Guidance Downtown Campus Page 64 of 250
(1) LEVEL 3 PPE: N95, face shield, trauma gown, (1) pair of inner gloves (Blue
Nitrile), knee high boot covers, hood
(2) One pre-identified staff member would operate as a trained “observer” role for
whole donning/doffing operation. (No PPE needed)
5) Initial Environmental Health and Safety (EHS) responsibilities
a) Report to 8m for briefing. Ensure that there are two Trained Observers (one for
8m and one for 4760)
b) Report to Rm 4760 as soon as possible to assume the role of Safety Officer/observer.
c) Begin communications process with Administrative Supervisor or Incident Command as
needed.
6) Initial UPD/Security Responsibilities
a) Ensure all UPD/Securitas officers have (and are wearing) appropriate PPE
b) Open room 4760 for clinical staff.
c) Block vehicle traffic to access road between Upstate and Crouse
d) Stop all outside pedestrian traffic around 4th floor entrance until EVS has cleaned the
area.
e) Verbally warn all impacted departments on 4th
and 8th
floor (surgical specialties, EPIC
training, etc.) of pending restriction of movement if time allows.
f) Stop all pedestrian traffic around gold elevator lobby on the 4th
floor
g) Stop and hold one of the larger gold elevators on the 4th
floor once the bed/staff from 8m
has moved down.
h) Stop all pedestrian traffic on the 8th
floor until EVS has cleaned the area.
i) Advise Safety officer or Administrative Supervisor that this has been done and area is
clear.
j) Public Safety will capture the elevator and hold it on the 4th floor using a key to put it
into independent service.
i) UPD/Public Safety will take the elevator to the 4th floor, leaving the key in the
elevator, and vacate it.
ii) Once nursing staff gets on the elevator, with the patient, they need to press and hold
the 8th floor button until the door closes.
iii) Once they arrive on the 8th floor, nursing staff will exit the elevator and continue the
patient transport.
iv) UPD/Public Safety will have an Office stationed in the 8th floor elevator lobby who
will make sure that no one takes the elevator until housekeeping has cleaned the
elevator.
v) Once that is complete, we will place the elevator back in service and remove the key
7) Initial Environmental Services Responsibilities
a) Ensure personnel have and are wearing appropriate levels of PPE
b) Ensure clinical staff inside room 4760 have needed supplies for doffing/cleaning
c) Stage all needed equipment and personnel outside room 4760 in the hallway once EMS
arrives at Upstate.
d) Communicate with Administrative Supervisor or Safety Officer once EVS is ready.
e) EVS will clean, starting in room 4760 and moving outward to the hallway/elevator, once
EMS has completely decontaminated their vehicle and everyone has doffed all PPE.
8) Once in Rm 4760 the Trained Observer must:
Upstate Hospital EVD Guidance Downtown Campus Page 65 of 250
a) Verify all personnel are wearing appropriate levels of PPE
i) That there are at least two staff members from 8m are present and 3 staff members
from the ED.
ii) Verify the following teams are staged and ready
b) University Police/Security in position
c) Environmental Services in position wearing appropriate PPE
d) 8m room is ready.
e) 4760 is prepared also 2 rigid waste containers & blue mats are kept outside doors for
Ambulance
f) Verify Supplies
(1) Task EVS with providing more as needed.
(2) 4 red bag (meeting ASTM 1922 and ASTM1709 standards for 480 grams tear
resistance and 165 grams of impact resistance.)(large)
(3) 1 rigid outer container to hold red bag (meeting ASTM 1922 and ASTM1709
standards for 480 grams tear resistance and 165 grams of impact resistance.) .
(4) container of bleach wipes for the EMS crew member to remove any gross
decontamination
(5) 10 absorbent pads.
(6) large blue floor pad (for doffing PPE)
(7) One small blue pad (for under rigid container) to be located next to hot zone.
(8) impermeable sheet/coverall is ready for patient
(9) Emisis bucket on 8m bed.
g) Verify all staff are donned appropriately.
9) Once Ambulance Arrives
a) EMS should be instructed to remain in ambulance until Upstate staff are ready to allow
entrance by staff in PPE.
i) This should be communicated by 8m staff in PPE speaking to driver or opening rear
of ambulance
b) UPD/Security officer must be stationed near EMS vehicle but far enough away to prevent
accidental contact with the vehicle itself or any personnel.
c) Place yellow ramp on curb so that the EMS stretcher may be moved inside the 4760rm
vestibule to enable patient transfer. (see room diagram)
d) If the patient is ambulatory instruct EMS crew to assist the patient to walk up the ramp
and sit on the 8M bed waiting inside 4760
e) All “suit Buddies” should remain at least 6 feet away from the patient at all times
(regardless if wearing PPE)
f) Place a blue disposable sheet on the ground at the rear of the EMS ambulance to allow
for a collection point for waste materials accidentally brought out of the ambulance.
g) The EMS stretcher can be placed back into the rig and the disposal sheet can be carefully
gathered and placed in a waste receptacle once transfer is complete
h) Advise the EMS Crew to roll stretcher out of vehicle
i) Disconnect all equipment not needed for the transfer or other clinical needs and place it
on the blue mat at the rear of the ambulance.
j) All personal patient items should be transferred with the patient.
Upstate Hospital EVD Guidance Downtown Campus Page 66 of 250
k) Ensure patient is covered in an impermeable coverall or sheet if not already placed
therein by the transporting EMS crew.
l) Once patient transfer from EMS stretcher to 8m bed is complete inside Room 4760
m) Move the patient to 8m as safely and quickly as possible placing the hand-rails of the bed
in the lowered or “down” position as needed to move bed through doors.
n) 8m personnel should utilize designated path of travel (see diagrams at end of this sheet)
i) Once nursing staff gets on the elevator, with the patient, they need to press and hold
the 8th floor button until the door closes.
ii) Once they arrive on the 8th floor, nursing staff will exit the elevator and continue the
patient transport.
o) If there are any spills or possible body fluid dispersal during the time moving 8m staff
should alert (by voice) the nearest UPD/Security officer or EVS team member.
Environmental Services will utilize appropriate spill protocols once this area has been
identified.
i) Transport of the patient should not be stopped or slowed for any reason.
p) Once Patient has arrived in 8m
q) Every effort should be made to doff those 8m transport personnel as they would have
expended a lot of energy during the moving process.
r) Monitor vitals per guidance.
10) Once transport of the patient has been initiated to 8m
a) Ems personnel should begin decontaminating their vehicle.
b) Upstate Suit Buddies should
i) Move Class A waste bins and cleaning supplies toward the transport vehicle.
ii) Upstate personnel should not decontaminate the transport vehicle. Instead they should
serve as runners/assistants to the EMS crew.
c) EMS personnel will then doff all PPE in room 4760 vestibule or outside if weather
permits.
d) Ask EMS personnel if they have a set of instruction or training sheets for properly
doffing their agencies specific PPE. If possible this sheet should be utilized by the Safety
Officer or Observer role.
e) EMS/Fire agencies may have internal procedures which enable their own trained “PPE
Observer/suit buddy” to be present in order to assist their crew with doffing. If there are
designated EMS/FD supervisors or trained buddies to fill this role than Upstate personnel
should continue to serve as assistants.
f) Every effort should be made to integrate Upstate’s waste disposal process with their
agency specific doffing procedures.
g) EMS personnel will be considered free to leave per their agencies guidelines &
NYSDOH protocols once they have doffed safely.
h) Showers and scrubs should be made available to EMS personnel as needed,
i) Once EMS has successfully doffed their PPE the 3 Upstate Suit Buddies would then
begin doffing PPE as appropriate once all blue sheets, discarded PPE and other waste is
properly disposed of in (meeting ASTM 1922 and ASTM1709 standards for 480 grams
tear resistance and 165 grams of impact resistance.) red bags
j) Rural Metro will provide personnel to clean their equipment outside 4760 as well as a
trained observer/supervisor
Upstate Hospital EVD Guidance Downtown Campus Page 67 of 250
11) Terminal Cleaning of space and returning to normal operations:
a) Environmental services would then clean any spills or gross contamination as needed
i) Room 4760 from red/yellow line out to hallway.
ii) The hallway leading from room 4760 to the gold elevators
iii) Ride another elevator to the 8th
floor (clean the one they rode in)
iv) The hallway from the goal elevator to the entrance of 8m
v) Any gross contamination ES should follow spill policy
vi) Expect at least a 45min to 1 hour cleaning turn around for hallways and elevators
vii) Notify Nursing Administrative Supervisor when completed.
viii) Restock waste/ cleaning supplies in 4760 as needed.
ix) Once Environmental Services cleans UPD/Security would then release that area to
normal pedestrian traffic and verbally advise those impacted area managers that
operations have concluded.
EMS
4th floor path of travel
Upstate Hospital EVD Guidance Downtown Campus Page 68 of 250
EVD Procedure
Procedure Issue Date: 2/16/15 Applies to: Downtown
Last Revision Date: 2/16/15
Last Review Date: 2/16/15
Environmental Infection Control/Waste
Environmental Infection Control- this process will be monitored by the Trained Observer on
site working in close consultation with Environmental Services and Environmental Health and
Safety.
1 ) Below is a list describing several types of waste that would be generated during the care of
a suspected or confirmed EVD patient
a) Patient specimens collected for laboratory testing
b) Waste generated from the testing of patient specimens in the laboratory
c) Waste generated from any invasive procedure
d) Personal protective equipment (PPE)
e) Single use devices (Recycling of SUDs that may normally be done is
unacceptable)
f) Disposable commodes, bed pans and/or urinals
g) Items used for environmental cleaning and disinfection
h) Sheets, food items, feces, urine, cubicle curtain, supplies, any other disposable items
i) Stained ceiling tiles
j) Mattress covers
k) Mattresses with cracks/ tears/ penetrations
l) Feces, urine and vomit, and liquid waste from washing m) Sharp objects (e.g. needles, syringes, glass articles) and tubing that has been in contact
with the bloodstream
n) All items in contact with the patient
o) Furniture that has become compromised
p) Disposable food trays, dishes, and cutlery
q) Disposable dedicated medical equipment
r) Materials used to clean up spills of body fluids 2) Any procedure performed in the patient room will be done in PPE level 1 or level 2, while
most procedures done in the anteroom will be done in Level 3 PPE. See PPE Roles Matrix
and corresponding PPE donning and doffing check sheet at the beginning of this document.
3) Use only hospital EPA approved disinfectant for cleaning (single use only)
4) Stericycle is the designated waste contractor
a) Maureen Guile 518-365-0046
b) Selin Hobry VP legislative and regulatory affairs 847-943-6685
Upstate Hospital EVD Guidance Downtown Campus Page 69 of 250
5) All equipment used for the treatment of a suspect case must be kept separate and not used by
any other patient.
6) Category A Waste from a highly suspect (but not clinically diagnosed EVD patient will be
sequestered in Room 8216
7) Rm 8216 Class A waste storage room is negative to the corridor and exceed the 6 air
exchange/ hour requirements (has 12 air exchanges/ hour)
8) Use only a mattress and pillow with plastic or other covering that fluids cannot get through
9) Should there be waste that is larger than the containers available, EVS will contact the
vendor immediately referring to US DOT Special permit 16279
a) For 8M
i) 8132 and 8134 place into room 8216
ii) Terminally clean 8132 and 8134.
iii) Leave large trash can (no lid) with red bag (meeting ASTM 1922 and ASTM1709
standards for 480 grams tear resistance and 165 grams of impact resistance.) for
waste in patient room.
10) Discard all linens, pillows, mattresses, privacy curtains, sharps container as Category A
waste.
11) Any reusable equipment must be cleaned and disinfected according to manufacturer’s
instructions.
a) See equipment specific cleaning items listed in each clinical procedure as needed in this
document.
CLEAN UTILITY EVD- ROOM 8228 CLEAN SUPPLY EVD- ROOM 8218
Item Volume Item Volume
1.5 ML regulated
medical waste bags
meeting ASTM 1922
and ASTM1709
standards for 480
grams tear resistance
and 165 grams of
impact resistance.
6 DOZ
CAT A GREEN
Poly WASTE
BARRELS
6 EACH
12" twist ties 500 Each 36" Bungee Cords 12 Each
Liqui-loc @ 3.2 ounces
which solidifies 3000cc 120 3.2 oz bottles Instazorb 12 @ 1 gallon
Clorox bleach germicidal
cleaner 20 Gallon bottles 18# Zip Ties 200 Each
Clorox wipes - containing
110 wipes 12' x 12' per
bucket
3 Buckets
Clorox wipes - containing
110 wipes 12' x 12' per
bucket
5 Refills @ 110 sheets
per
1 metal transport dolly 1
4 solid waste cans 4
Upstate Hospital EVD Guidance Downtown Campus Page 70 of 250
Disposable needle bucket-
wall mounted 5, 1 gallon disposable
Disposable needle bucket-
floor unit 1 floor unit disposable
Disposable Swifter mop 1 Each
Soiled Utility Biohazard Waste - Authorized Personnel Only- Room 8216
Area designated as CAT A WASTE holding- sequestered as required. Transport time will be 3 am to
5 am as required
Disposal of Body Fluids (Toilet & Shower)
1) Liquid wastes may be disposed of in the sanitary sewer as prescribed below.
2) Bleach was selected as the best choice disinfectant for waste water treatment plant
purposes.
3) Clorox® Bleach – off the shelf (Clorox
® is a registered trademark of The Clorox
Company.)
4) Equipment Needed
a) PPE (Level 1) for Clinical staff in Patient Room (hot zone)
b) A straight bleach solution in a container for use directly in the toilet
c) Receptacle for waste
d) Disposable commode bucket liners as necessary
e) Bedside commode as necessary
f) Disposable patient under pad or other absorbent covering
g) Trash cans lined with red bag (meeting ASTM 1922 and ASTM1709 standards for 480
grams tear resistance and 165 grams of impact resistance.)
h) Disinfectant bleach wipes—approved for use in EVD patient care areas
Fluid Disposal Procedure (SOLIDIFICATION).
1) This procedure is for waste not collected directly into the toilet by the patient.
2) It should be applied in any location where an EVD patient excretes liquid wastes into a
collection vessel other than a fixed toilet.
3) Proceed to designated area and don PPE according to hospital procedure for PPE in
isolation rooms for EVD patients.
4) Inside room Don 3rd
pair of nitrile gloves
5) Stage small blue wrap, solidifier, bleach solution and liquid collection container near area
of collection
6) Lay blue wrap out and place waste collection container in the center of the blue wrap
7) Liquid bleach may be added to the collection container at the direction of the trained
observer
8) Empty Foley bag into liquid container
9) Slowly add solidifier from the edge of the container
10) Allow container to stand for 2 minutes
11) Once liquid is completely solidified surround and wrap the container in the blue wrap.
Place the entire wrapped container into the red bag (meeting ASTM 1922 and ASTM1709
Upstate Hospital EVD Guidance Downtown Campus Page 71 of 250
standards for 480 grams tear resistance and 165 grams of impact resistance.) waste
receptacle
12) Remove outer gloves and decontaminate hands with a disinfectant bleach wipe.
Patient Flush Procedure
1) This procedure is for waste excreted directly into the toilet by the patient.
2) It should be applied in any location where an EVD patient excretes liquid wastes into
toilet. Auto-flush toilet valves must be disabled to ensure manual flushing only.
3) Place two containers of bleach in the restroom—one to clean the bowl (straight bleach)
and bleach wipes
4) Instruct the patient not to flush the toilet after use
5) Before patient use, staff in appropriate PPE will apply bleach solution around the bowl in
the same manner as liquid/gel toilet bowl cleaner. Use one cup of bleach
6) Allow 10 minutes of contact time after patient use then flush toilet.
7) Wipe the surfaces with bleach wipe to ensure complete surface contact.
Patient Shower Procedure
1) Immediately after the shower, apply to shower floor drain one cup bleach (sodium
hypochorite)
2) After shower, apply bleach solution wipe to ensure contact with all areas of surface, and
allow to air dry.
Bed Pan Solidification Procedure
1) Don additional outer gloves.
2) Place bed pan under patient
3) Prep small area on floor with blue wrap
4) When patient finished move bed pan to blue wrap on the floor
5) Clean patient. Place wipes into red waste bin.
6) Add bleach to bed pan as directed by trained observer
7) Carefully pour full container of solidifier into the bed pan
8) Let stand for kill time
9) Wrap up bed pan with blue wrap then place into red waste bin
10) Disinfect gloved hands then remove outer gloves.
Category A Waste Removal EVD
1) Nursing
a. To be Performed in the Hot or Warm Zone
b. Use proper PPE per Upstate EVD Guidelines
c. Line a rigid container (with Bio- hazard sticker) with two red rmw bags meeting ASTM
1922 and ASTM1709 standards for 480 grams tear resistance and 165 grams of impact
resistance.
Upstate Hospital EVD Guidance Downtown Campus Page 72 of 250
d. Once the bag is half full, carefully remove the bag from the rigid container. The
individual bag can weigh no more than 22 pounds when filled.
e. Pour bleach in the bag to saturate the contents of the bag with approximately 8 OZ (1
cup).
f. Grasp the bag just above the filled portion of the bag. Carefully gather the slack of the
bag in one hand until the entire width is gathered in one hand.
g. Carefully twist the neck of the bag until wound tightly.
h. Fold the neck of the bag in half.
i. Use zip tie to tightly secure the neck of the bag.
j. Wipe the outside of the bag with bleach wipes and allow for proper dwell time (2
minutes).
k. Place the bag and bleach wipe(s) in a second red rmw bag (meeting ASTM 1922 and
ASTM1709 standards for 480 grams tear resistance and 165 grams of impact resistance.)
l. Red biohazard trash cans should be visually inspected after every waste removal process
and decontaminated with bleach wipes as needed
m. Repeat steps E through I.
2) Environmental Services
A. EVS will don LEVEL 3 PPE and locate themselves in the clean zone outside the
designated patient care area. (see decontamination zone maps in Appendix A)
B. Open the CATEGORY A WASTE drum. Remove the zip tie and 6 mil plastic liners. Set
the zip tie aside where it will be available at a later time. Line the 55 gallon CATEGORY
A WASTE drum with a 6 mil plastic liner.
C. Pour 2 gallons of Instazorb in the bottom of the 6 mil plastic liner.
D. Place double bagged red rmw bags in CATEGORY A WASTE drum until full or weight
capacity is reached. CATEGORY A WASTE drum may not exceed 500 pounds.
E. Once the CATEGORY A WASTE drum is full, properly secure the liner. Gather the liner
in the same manner as the red bag as stated in step E above. Once complete, follow
repeat steps F and G on the 6 mil liner.
F. Place the lid on the CATEGORY A WASTE drum and properly secure the metal band.
Pay attention to the markings on the lid that indicate the proper positioning of the band.
G. Wipe down the exterior of the CATEGORY A WASTE drum with bleach wipes and
ensure the proper dwell time of 2 minutes.
A. Once proper dwell time (2 mins) has occurred, the CATEGORY A WASTE drum can be
relocated to 8216 via the appropriate route
Spill Cleanup
1. Alert team.
2. Need to have at least 2 people in PPE full
3. Employee entering area to assist with clean up sanitize gloved hands then don an
additional pair of gloves on the outside. (3 total)
4. Obtain the spill kit [absorbent pad, bleach wipes, red bag ,(sharps container, dust pan/
tongs as directed)]
5. Assist Patient first by cleaning gross contaminants.
6. Establish a spill perimeter.
Upstate Hospital EVD Guidance Downtown Campus Page 73 of 250
7. Position clean up supplies including the red bag waste container outside the spill
perimeter to ensure easy access.
8. Visually check PPE of both people in the area/room and clean any visible contamination
9. Sanitize gloves
10. Cover spill from the outside working in with bleach wipes until entire spill areas is
covered.
11. Place absorbent pad over the bleach wipes.
12. Pick up any broken glass, plastic or sharp materials with dust pan, tongs or some other
mechanical device as directed by the trained observer. Do not use your hands. Place
material in approved sharps container.
13. If no potentially sharp items are present in spill area, obtain an additional spill pad. Fold
pad over and lightly press clean pad down on covered spill to ensure complete bleach
contact. Disposed pad when complete
14. Allow for appropriate contact time (5 minutes)
15. Clean- up spill material from outside-in
16. Sanitize gloves
17. Perform a final wipe of the spill area with bleach wipes/ swiffer with bleach wipes as
directed by the Trained Observer.
18. Re-inspect area and PPE for gross contamination clean as needed
19. Remove outer gloves
20. Follow waste management for Category A Waste Removal protocol
STOP If:
At any time there is a question or concern.
At Any time there is contact with blood or bodily fluids.
o Remove gross contamination before proceeding with spill clean-up process
Directed to do so by the trained observer or other members of the team
Upstate Hospital EVD Guidance Downtown Campus Page 74 of 250
Category A Waste Handlin/ Packaging
This procedure is identical regardless of location inside the hot or warm zone. (patient rooms,
ED, POC Lab, EVD designated entrance on the 4th
floor) to be performed by clinical staff
members in Level 1 or Level 2 PPE. Please reference EVD Decontamination Room diagrams
(Appendix A) for more information.
Upstate Hospital EVD Guidance Downtown Campus Page 75 of 250
EVD Procedure
Procedure Issue Date: 2/16/15 Applies to: Downtown
Last Revision Date: 2/26/15
Last Review Date: 2/26/15
EVS WASTE REMOVAL – Cold zone to Waste Staging Rm 8216
Room 8216 shall remain locked at all times. The room has a dedicated key assigned only to the EVD unit
to ensure no unauthorized access.
Step 1. CAT A WASTE- Poly Drum ready for waste holding.
Step 2. Open barrel and 6 mil.liner (clear lining). Add absorbent material to the bag, 2
gallons.
Step 3. Place double bagged waste directly into the Poly Drum.
Upstate Hospital EVD Guidance Downtown Campus Page 76 of 250
Step 4. Twist clear 6 mil liner carefully
Step 5. Place zip tie over the clear 6 mil liner secure
Step 6. Place cover on Green poly barrel- secure with metal binder- wipe with bleach
cloths dwell time is 2 minute. Stage in room 8216
Upstate Hospital EVD Guidance Downtown Campus Page 77 of 250
Class A Waste Travel Routes
a) The section below delineates the exact route EVS will travel in order to transport clean
55 gallon drum from various possible points of waste generation during the care of an
EVD patient. Since the plan accounts for the avoidance of the ED in all but the most
extreme circumstance (see EVD Direct Admit section) typically only one of these
pathways would be used at any one time.
b) Transportation of clean 55 gallon drum would be coordinated with security, EVS, EHS
and Incident Command as needed.
c) Once transported to the dock area each 55 gallon drum would be placed in to designated
95 gallon overpack containers for storage and shipment by Stericycle.
d) EVS staff will don Level 3 PPE for transport of clean 55 Cat A drums to secured trailer.
from ED
1) Travel the 2 East hall to #3 Gold Elevator. Take this elevator to the basement. Follow
basement west corridor to the ROC. Take the freight elevator to the first floor. Turn left
towards the receiving dock. Using swipe access enter dock area.
2) 55 gallon CAT A Waste drum will be placed into the 95 gallon overpack CAT A
WASTE.
A. The 95 gallon overpack should not be stored or packed in the Category A Waste
storage area. It will be kept near the secure trailer area
B. the outer category A waste drum must remain in the cold zone
C. Remove the 55 Gallon special Category A DOT Waste Green Drum/Poly Drum
from the Category A Waste storage area (containers should have been wiped
down prior to movement).
D. Overpack the 55 Gallon special Category A DOT Waste into the plastic 95 gallon
overpack drum. The 95 gallon overpack shall be closed in accordance with the
manufacturer’s instructions and the lid shall have duct style tape applied at the
interface of the lid and the body of the drum in a manner to secure the lid in the
closed position and also to provide additional security and prevent tampering.
E. Wipe down the outer 95 gallon overpack with bleach wipes
F. Only Label the outermost 95 gallon overpack with the Category A labels.
G. Load the 95 gallon overpack onto the Stericycle trailer. Secure trailer gate
immediately upon exiting
H. Stage CATEGORY A WASTE drum in designated CATEGORY A WASTE
trailer separated from other regulated medical waste in secure trailer.
I. EVD Drum cart will be visually inspected and cleaned with bleach wipes after
each use.
from 8M (Patient Care Area & POC Lab)
1) Take Gold elevator #3 to the basement. Follow basement west corridor to the ROC. Take the
freight elevator to the first floor. Turn left towards the receiving dock. Using swipe access
enter dock area. Overpack 55 gallon CAT A Waste green drum into the 95 gallon CAT A
WASTE overpack. Stage CATEGORY A WASTE drum in designated CATEGORY A
WASTE trailer
Upstate Hospital EVD Guidance Downtown Campus Page 78 of 250
2) 55 gallon CAT A Waste drum will be placed into the 95 gallon overpack CAT A WASTE.
a) The 95 gallon overpack should not be stored or packed in the Category A Waste storage
area. It will be kept near the secure trailer area
b) the outer category A waste drum must remain in the cold zone
c) Remove the 55 Gallon special Category A DOT Waste Green Drum/Poly Drum from the
Category A Waste storage area (containers should have been wiped down prior to
movement).
d) Overpack the 55 Gallon special Category A DOT Waste into the plastic 95 gallon
overpack drum. The 95 gallon overpack shall be closed in accordance with the
manufacturer’s instructions and the lid shall have duct style tape applied at the interface
of the lid and the body of the drum in a manner to secure the lid in the closed position and
also to provide additional security and prevent tampering.
e) Wipe down the outer 95 gallon overpack with bleach wipes
f) Only Label the outermost 95 gallon overpack with the Category A labels.
g) Load the 95 gallon overpack onto the Stericycle trailer. Secure trailer gate immediately
upon exiting
h) Stage CATEGORY A WASTE drum in designated CATEGORY A WASTE trailer
separated from other regulated medical waste in secure trailer.
i) EVD Drum cart will be visually inspected and cleaned with bleach wipes after each use.
from 4 South (Designated EVD Entrance for EMS)
1) Turn right down 4 south hall way to Gold elevator #3 to the basement. Follow basement west
corridor to the ROC. Take the freight elevator to the first floor. Turn left towards the
receiving dock. Using swipe access enters dock area. . Overpack 55 gallon CAT A Waste
green drum into the 95 gallon CAT A WASTE overpack as defined in step 12 b. Stage
CATEGORY A WASTE drum in designated CATEGORY A WASTE trailer
2) 55 gallon CAT A Waste drum will be placed into the 95 gallon overpack CAT A WASTE.
a) The 95 gallon overpack should not be stored or packed in the Category A Waste storage
area. It will be kept near the secure trailer area
b) the outer category A waste drum must remain in the cold zone
c) Remove the 55 Gallon special Category A DOT Waste Green Drum/Poly Drum from the
Category A Waste storage area (containers should have been wiped down prior to
movement).
d) Overpack the 55 Gallon special Category A DOT Waste into the plastic 95 gallon
overpack drum. The 95 gallon overpack shall be closed in accordance with the
manufacturer’s instructions and the lid shall have duct style tape applied at the interface
of the lid and the body of the drum in a manner to secure the lid in the closed position and
also to provide additional security and prevent tampering.
e) Wipe down the outer 95 gallon overpack with bleach wipes
f) Only Label the outermost 95 gallon overpack with the Category A labels.
g) Load the 95 gallon overpack onto the Stericycle trailer. Secure trailer gate immediately
upon exiting
h) Stage CATEGORY A WASTE drum in designated CATEGORY A WASTE trailer
separated from other regulated medical waste in secure trailer.
i) EVD Drum cart will be visually inspected and cleaned with bleach wipes after each use.
Upstate Hospital EVD Guidance Downtown Campus Page 79 of 250
EVD Procedure
Procedure Issue Date: 2/16/15 Applies to: Downtown
Last Revision Date: 2/16/15
Last Review Date: 2/16/15
Personnel Needed: 1 8m Nurse
Equipment Needed: EPA approved disinfectant, disposable cloths, disposable mop heads,
mop handle.
Patient Room Cleaning Procedure 8M/ EVD
1) Cleaning should occur at least daily or more if possible.
2) While wearing Level 1 or Level 2 PPE in Hot /Warm zone
3) Use EPA approved disinfectant, disposable cloths, disposable mop with disposable mop
heads
4) Empty all waste/linen/debris dispose of per CATEGORY A waste handling procedures.
5) Use caution and avoid agitation or unnecessary movement of linens to prevent additional
contamination of surfaces or personnel.
6) Proceed to restroom – Use one EPA approved disinfectant wipe for each fixture/ piece
equipment. Dispose of each wipe as CATEGORY A WASTE. Wipe each: faucets, sink,
toilet handle, toilet seat, and outer bowl, grab rails, dispensers and mirrors. Spot wash walls
as needed.
7) Proceed to patient room- Use EPA approved disinfectant wipes for each fixture with one
wipe. Dispose of each wipe as CATEGORY A WASTE.
a) Wipe each: over the bed table, night stand, IV pole, bedrails, monitors, cables, call bell,
door knobs, wall dispensers, chair, TV remote, all horizontal surfaces. Spot wash walls as
needed.
8) Repeat process two times for each fixture/surface or piece of equipment
9) Refill all supplies as needed.
10) Mop bathroom floor, beginning at the far corner working toward the door.
a) remove mop head. Dispose of as CATEGORY A WASTE. Replace mop head, mop
patient room beginning at the far corner working toward the door. Dispose of as
CATEGORY A WASTE.
11) Clean mop handle place in bathroom shower. Dispose of wipe AS CATEGORY A WASTE
12) Class A waste storage containers in Hot/Warm zone will be visually inspected and cleaned
with bleach wipes once a day.
13) Self inspect area for visible contamination.
Upstate Hospital EVD Guidance Downtown Campus Page 80 of 250
EVD Procedure
Procedure Issue Date: 2/16/15 Applies to: Downtown
Last Revision Date: 2/16/15
Last Review Date: 2/16/15
Anteroom Cleaning Procedure 8M/ EVD
1) With Level 1or Level 2 PPE’s (Personal Protective Equipment), put on protective clothing as
required.
2) Use EPA approved disinfectant, disposable cloths, disposable mop with disposable mop
heads
3) Empty all waste/linen/debris dispose of per CATEGORY A waste handling procedures.
4) Use EPA approved disinfectant wipes. Use one wipe for each fixture/horizontal surface. Re-
wipe all fixtures and horizontal surfaces.
5) Dispose of each wipe as CATEGORY A WASTE. Spot wash walls as needed.
a) Remove outer gloves; sanitize inner gloves, re glove.
6) Refill all supplies as needed.
7) Replace mop head, mop anteroom beginning at the far corner working toward the door.
8) Dispose of as CATEGORY A WASTE. Clean mop handle hang in defined area.
9) Dispose of wipes as CATEGORY A WASTE
10) Self inspect area.
81
Upstate Hospital EVD Guidance Downtown Campus Page 82 of 250
EVD Procedure
Procedure Issue Date: 2/16/15 Applies to: Downtown
Last Revision Date: 2/16/15
Last Review Date: 2/16/15
EVD Sharps Container Removal
1) With PPE level 1. When sharps container is ¾ full
2) All sharps waste must be packaged in pre –staged FDA cleared sharps disposal
containers that are securely closed in accordance with the manufactures
instructions.
3) Close lid
4) Open wall mounted cabinet.
5) Remove plastic sharps container.
6) Place container inside a red bag (meeting ASTM 1922 and ASTM1709 standards
for 480 grams tear resistance and 165 grams of impact resistance.)
7) For both floor unit and wall mounted unit add approximately 1 cup bleach to
sufficiently cover surface of contents as required by the DOT Special Permit-16279.
8) Close red bag by carefully gathering the slack of the bag in one hand until the
entire width is gathered in one hand.
9) Carefully twist the neck of the bag until wound tightly
10) Bend the twisted top over
11) Carefully place a twist tie around the twisted bag. Pull the twist tie closed
securing the contents in the bag.
12) While holding the bag wipe the outside of the bag with a bleach wipe with 2 min
dwell time.
13) Place secure, disinfected bag into another bag. Repeat steps 6 thru 10
Upstate Hospital EVD Guidance Downtown Campus Page 83 of 250
EVD Procedure
Procedure Issue Date: 2/16/15 Applies to: Downtown
Last Revision Date: 2/16/15
Last Review Date: 2/16/15
Discharge EVD Warm/Hot Zone Cleaning
Personnel Needs: 1 EVS Cleaner
Equipment Needed: Clorox disposable wipes, disposable mop heads. Procedure: 1. Level 1 PPE. All waste, linens, bodily fluids, gross contaminants should be
removed and disposed of by nursing prior to EVS Cleaning Clean and disinfect
all surfaces listed
2. Proceed to restroom – clean all fixtures-, including light, mirror, sink fixtures
and toilet. Remove and discard supplies, mop floor, dispose of mop handle as
CAT A waste.
3. Clean the entire over bed light with a bleach cloth. Use friction to help reduce
the bio-load when cleaning.
4. Clean all with bleach wipes, window sill, window frame, pull cord/chain or rod
and patient contact furniture.
5. Clean exterior of radiator/heater enclosure, ensure vents are clean.
6. Clean the closet interior & exterior.
7. Clean wall dispensers *Pay special attention to pump when cleaning units.
8. Clean the entire over bed table, top to bottom.
9. Clean the pillow(s).
10. Clean bed as required in bed cleaning procedure.
11. Clean head boards (both front and back), phone and monitor. Clean remaining
patient contact items in room: chairs, cushions, all furniture, door handles, call
bell, TV remote, channel changer equipment and c-locker/isolation cart (inside
& out).
12. Detail clean walls- replacing bleach wipe after four wipes of the wall.
13. Mop bathroom floor- mop room floor
14. Proceed to Ante room. Clean sink, counter, doors, knobs, lights, vents, mirrors,
detail clean mirrors, walls, all horizontal surfaces, mop floor.
15. Remove outer gloves, purell, reglove. Re-enter patient bathroom perform steps 2
through 13 again.
16. EVS personnel will don Level 1 or Level 2 PPE
17. Repeat step 14.
18. UV bathroom/patient room/ante room
19. Self-inspect area.
Works Cited
CDC. (2015, Feb 19). CDC Center forDisease Control and prevention. Retrieved Feb 20, 2015, from CDC.gov:
http://www.cdc.gov/vhf/ebola/healthcare-us/cleaning/hospitals.html
Upstate Hospital EVD Guidance Downtown Campus Page 84 of 250
EVD Procedure
Procedure Issue Date: 2/16/15 Applies to: Downtown
Last Revision Date: 2/16/15
Last Review Date: 2/16/15
Dietary
Procedure:
1. Meals will be served on 100% disposable service (dishware, trays and eating utensils). Tray
ticket will be marked "All Disposables and Not to be Returned to Food and Nutrition"
2. Under no circumstance is the tray or any utensils to be returned to Food and Nutrition
Services once it has been placed in the warm or hot zones and must be treated as Class A
medical waste. Food/trays/utensils that stay in the cold zone can be disposed of in regular
waste by nursing staff on 8m.
3. Nursing will interpret orders for isolation based on the disease type and communicate this to
Food and Nutrition according to standard procedures. Off menu requests by the patient will
be determined clinically acceptable on a case by case basis at the time.
4. The entire 8m unit space will not be entered by Food and Nutrition Associates.
5. Food and Nutrition will deliver the tray/nourishment to the cart outside of locked unit doors
to 8m and then they will notify nursing staff via VOCERA or phone that it is available for
them to move in to the unit.
6. Menu selection will be obtained via phones/VOCERA from patient room by nursing staff
twice a day or as needed
7. The patient may utilize a phone and call 464-4305 to the Food and Nutrition office
Supervisor to place a meal order if clinically appropriate.
Upstate Hospital EVD Guidance Downtown Campus Page 85 of 250
EVD Procedure
Procedure Issue Date: 2/16/15 Applies to: Downtown
Last Revision Date: 2/16/15
Last Review Date: 2/16/15
Support Services Employees & Family
1) Family Support
a) UH will have a designated room on the 8th
floor near the Ebola unit where families of
Ebola patient(s) and/or their significant others (extended families) can meet and gather
for comfort and support.
A. Family Emotional Support/Spiritual Support: UH will support the families using skilled
social workers and chaplains who will provide direct support services to the families
including emotional counseling, crisis intervention and bereavement counseling as
needed. Social workers will be available to help with findings resources for the families
as needed including temporary shelter and transportation They will facilitate
communication with the physicians and nursing staff so that the families’ questions can
be answered promptly. Social work will coordinate appropriate referrals to community
agencies that can help support the families as needed. Chaplains can provide religious
services as needed and will support and coordinate for the family religious contacts in the
community for their support as needed. Chaplains can provide religious rituals for
spiritual support when needed. Social work and the chaplains will conduct individual
assessments of families and they will identify specific family care plans for each family.
B. Family education on Ebola: Nursing and medical staff will provide “just in time”
education to the patient and their extended families on relevant EBOLA education to
alleviate fears and provide factual information to the family as they cope with the stress
of having a family member diagnosed and treated with Ebola. Nursing will develop in
EPIC care plans for the Ebola patient that identifies how care will be coordinated with the
families and describe the education that family will receive on Ebola.
C. Family Communication: All are providers as well as the social workers and chaplains
working in the family support area will use available communication tools such as
VOCERA/ ipads and telephone computers Skype technology to allow for frequent verbal
communication between the patient and their families as desired. When needed,
translation services will be provided using existing protocols so optimum communication
can be supported.
D. Family Comfort Services: Social Work will coordinate for the families’ meals and
snacks as needed in the family using the hospital food services. UH will support being
sure the family have access to TV and phone services as well as access to internet
services if needed and overnight accommodations as needed.
E. Games and entertainment resources, assessed as needed by the social worker, will be
provided for the family. (Examples: music, games, Electronic gaming: Wii, exercise
equipment, reading materials)
Upstate Hospital EVD Guidance Downtown Campus Page 86 of 250
2) Staff Support
A. UH will have a designated room on the 8th
floor near the Ebola unit for staff involved
with Ebola patient(s) can decompress and receive needed rest and support. Services able
to be offered:
B. Emotional Support/Spiritual Support: UH will support the staff using skilled social
workers and chaplains who will provide direct support services to the staff including
emotional counseling, crisis intervention and bereavement counseling as needed. Social
workers will be available to help with findings resources for the staff as needed including
on campus housing and transportation. Social work will coordinate for the staff any
appropriate referrals to community agencies that can help with staff’s family at home in
their absence. Chaplains can provide religious services as needed and will support and
coordinate for the staff contacts in the community for their support as needed. Chaplains
can provide religious rituals for spiritual support when needed. Social work and the
chaplains will conduct individual assessments of staff to identify specific employee care
plans that can determine how we can best sustain the employee in their active Ebola duty.
C. Staff education on Ebola: Nursing and medical staff will continually be provided as
needed with “just in time” education on Ebola care directed by the NYSDOH and CDC
to alleviate fears and provide factual information to help them cope with the stress of
providing care to an Ebola patient.
D. Family Communication: Social workers and chaplains working in the staff support area
will use available communication tools such as VOCERA/ ipads and telephone
computers Skype technology to allow for frequent verbal/visual communication
between the staff and their families as desired. When needed, translation services will be
provided using existing protocols so optimum communication can be supported.
E. Staff Comfort Services: Food Service will coordinate for the staff meals and snacks as
needed using the hospital food services. UH will support being sure the staff employed
have access to TV and phone services as well as access to internet services if needed and
overnight accommodations as needed in Clark Hall.
F. Games and entertainment resources, assessed as needed by the social workers, will be
provided for the staff. (Examples: music, games, Electronic gaming: Wii, exercise
equipment, reading materials)
Upstate Hospital EVD Guidance Downtown Campus Page 87 of 250
EVD Procedure
Procedure Issue Date: 2/16/15 Applies to: Downtown
Last Revision Date: 2/16/15
Last Review Date: 2/16/15
Communications/Public Relations
Procedure:
1) Upstate University Hospital’s Public and Media Relations Department, in conjunction with
Emergency Management and Hospital Administration, works together with local, state and
federal agencies to assess, update and communicate information regarding Ebola training and
care to Upstate Medical University staff through targeted and campus-wide communications.
2) A primary point of contact from Public and Media Relations is available 24 hours a day,
seven days a week, through the hospital's on-call system. A public information officer is
designated and available at all times to assist the team in external and internal
communications.
3) Public and Media Relations serves as the liaison for all media inquiries regarding Ebola and
the care of an Ebola patient at Upstate University Hospital and will make experts available to
media when appropriate. Upstate University Hospital protocol regarding release of private
patient information will be followed.
Upstate Hospital EVD Guidance Downtown Campus Page 88 of 250
EVD Procedure
Procedure Issue Date: 2/16/15 Applies to: Downtown
Last Revision Date: 2/16/15
Last Review Date: 2/16/15
Post Mortem Preparations
Equipment: 1 trained observer, 2 clinical personnel in Level 3 PPE, 4 clinical personnel in
Level 1 PPE, 2 mortuary or hospital personnel in double gloves, 1 cremation casket, 3
approved body bags, PPE doffing supplies as needed.
Procedure:
1) ONLY PERSONNEL TRAINED IN THE HANDLING OF INFECTED REMAINS, AND
WEARING PPE, SHOULD TOUCH, OR MOVE, ANY EBOLA-INFECTED REMAINS.
2) Preparation of the body: At the site of death, only nurses who have been trained in the
handling of infected remains will prepare the body.
a) Level 1 (PPE) must be worn while performing these tasks.
3) Notify Technical Director of Hospital Autopsy Service of the death of an Ebola patient.
Request appropriate body bags (3) and cremation casket.
4) For identification purposes, use video monitoring system to take a photograph of the
decedent's face. (see 8m Video Users Guide for more information)
5) Staff wearing Level 1 PPE will enter patient room with necessary supplies.
6) Pull bed sheet(s) up around body.
7) Do not wash or clean body.
8) Do not remove any inserted medical equipment from body.
9) Gently roll body wrapped in sheets while sliding first bag under body.
10) Complete transfer of body to first bag.
11) Zip up bag, minimizing any air in bag – do not push or compress air in bag.
12) Disinfect outside of bag with bleach wipes.
13) Disinfect gloved hands using EPA registered hospital disinfectant (bleach wipes).
14) Fold second bag around first bag and close bag, minimizing any air in bag.
15) Disinfect outside of second bag with EPA registered hospital disinfectant (Bleach wipes).
16) Disinfect gloved hands using EPA registered hospital disinfectant (bleach wipes).
17) Work the mega mover under the second bag.
18) Disinfect gloved hands using EPA registered hospital disinfectant (bleach wipes).
19) Decontaminate surface of body bag with EPA registered hospital disinfectant.
20) Notify trained observers that body is ready to be transferred to cremation container.
Upstate Hospital EVD Guidance Downtown Campus Page 89 of 250
21) Open anteroom door
22) Wheel cremation casket into clean side of ante room.
23) Open 3rd (heavy duty) body bag inside of cremation casket.
24) Disinfect gloved hands using EPA registered hospital disinfectant (bleach wipes).
25) Open Patient door.
26) Place double bagged body into the 3rd open body bag in wooden cremation container then
close bag .
27) Zip 3rd bag closed and place a purple lock seal on zipper and lock.
28) Place a toe tag on zipper with patient identification, including patient name, date of birth and
medical record #. Close cover on cremation casket.
29) Disinfect outside of cremation container with EPA registered hospital disinfectant (bleach
wipes).
30) Push/lift cremation container into cold zone. All personnel who placed the body in the
bags or sealed the container will remain in the anteroom.
31) A new set of workers will receive the body for transport to morgue
32) All personnel in the anteroom will proceed to doff PPE. Disinfect gloved hands using EPA
registered hospital disinfectant (bleach wipes).
33) Burgess & Tedesco Funeral Home/Crematory will load the cremation container into their
service vehicle and transport directly to their crematory for cremation.
a) Burgess & Tedesco Funeral Home will be responsible for obtaining the necessary
information for the death certificate, filing the death certificate with the local registrar,
obtaining the burial transit permit for cremation, and for supplying the necessary
cremation container.
34) All transportation, including local transport, should be coordinated with relevant local and
state authorities in advance. Interstate transport should be coordinated with CDC by calling
the Emergency Operations Center at 770-488-7100.
Upstate Hospital EVD Guidance Downtown Campus Page 90 of 250
35) EVD Procedure
Procedure Issue Date: 2/16/15 Applies to: Downtown
Last Revision Date: 2/16/15
Last Review Date: 2/16/15
Restraints for a Diagnosed EVD Patient
Procedure:
1. A patient will only be restrained if a determination is made that the patient is at risk of
harming him/herself or others
2. The treating clinician will determine the need for involuntary and/or physical restraints.
a) Where possible, involuntary or chemical restraint should be utilized since PPE may tear/rip
with the application of physical restraints.
3. Rationale for use of restraints will be documented in EPIC and must include duration of the
restraint.
4. Use of restraints will follow Upstate policy CMR-17 as much as practical ensuring the
utmost safety to 8m staff and the patient.
Upstate Hospital EVD Guidance Downtown Campus Page 91 of 250
EVD Procedure
Procedure Issue Date: 2/16/15 Applies to: Downtown
Last Revision Date: 2/16/15
Last Review Date: 2/16/15
Pharmacy
Procedure:
1. Non-Controlled Medications
a) Delivery
i) All medications will be labeled with required patient identifiers, medication name,
strength, quantity, route, and frequency as well as barcode.
ii) Scheduled unit-dose, bulk, and intermittent intravenous (IV) infusion medications
that will be administered between the times of 1600 the same day to 1600 the
following day will be delivered with the 1500 refill that takes place that same day.
iii) New medications orders and STAT orders that are not already available in the unit
will be delivered from the central pharmacy on the hourly runs by the pharmacy
runner.
iv) Unit-dose/Bulk Scheduled and “As Needed (PRN)” Medications
(a) Unit-dose medications will be delivered and stored in sealed, plastic bags
v) Continuous IV infusions (CIVI)
(a) CIVI not stocked by distribution will be delivered from central pharmacy
(b) 2 hour notification request via an intervention in Epic will be needed for
production and delivery
2) Intermittent IV medications
a) Intermittent IV medications will be delivered as lyophilized powder either in vials or
vials “pig-tailed” to compatible diluents bags dependent upon the medication.
b) Storage
i) Scheduled medications will be delivered into the large, teal, patient-room specific
medication bin
ii) PRN medications will be delivered to the small, purple, patient-room specific
medication bin
c) Destruction
i) All medications will be destroyed within the unit and not returned to central
pharmacy
3) Controlled Medications
a) Stock
i) Initial supplies of midazolam, fentanyl and morphine injection will be provided to 8M
when/if Ebola Isolation Unit receives a patient
ii) Additional supplies of other controlled substances will be provided when/if
prescribed
b) Delivery
Upstate Hospital EVD Guidance Downtown Campus Page 92 of 250
i) Controlled medications will be delivered the same as non-controlled medications with
the following additions
a. Delivery Sheet (Attachment A)
b. The pharmacist checking the medication will sign the delivery sheet for release
from the pharmacy
c. The delivering pharmacy technician will sign the sheet for delivery
d. The nurse receiving the medication will sign the sheet upon delivery
c) Storage
i) Controlled medications will be stored in a double locked cabinet in the unit (see
Attachment B)
d) Tracking (administration and waste)
i) CIVI
ii) Nursing will continue using the “Controlled Substance and Analgesic Administration
Record” for documentation of administration and waste. (Attachment C)
e) Unit-dose
i) Nursing will continue to document administration via the MAR in Epic
ii) Additionally, accountability and/or wastage of each dose will be managed using the
pharmacy generated Controlled Drug Administration Record (Attachment D)
f) Destruction
i) All controlled medications will be destroyed in the unit and not returned to central
pharmacy.
ii) Documentation of wastage/destruction will be performed using the “Controlled
Substance and Analgesic Administration Record” for CIVI or Controlled Drug
Administration Record for unit dose controlled substances.
iii) Controlled substance documentation forms will be returned to the pharmacy upon
completion.
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Upstate Hospital EVD Guidance Downtown Campus Page 97 of 250
EVD Procedure
Procedure Issue Date: 2/16/15 Applies to: Downtown
Last Revision Date: 2/16/15
Last Review Date: 2/16/15
Aerosol Generating Procedures (AGPS)
Procedure:
1. Avoid AGPs for EVD patients.
2. AGPS include Bi-level Positive Airway Pressure (BiPAP), bronchoscopy, sputum
induction, intubation and extubation, and open suctioning of airways.
3. If performing AGPs, use a combination of measures to reduce exposures:
4. HCP should wear PPE as described above
5. Limit the number of HCP present during the procedure to only those essential for patient-
care and support.
6. Entry and exit should be minimized during and shortly after the procedure.
7. Visitors should not be present during aerosol-generating procedures under any
circumstances.
8. Conduct environmental surface cleaning following procedures
Upstate Hospital EVD Guidance Downtown Campus Page 98 of 250
EVD Procedure
Procedure Issue Date: 2/16/15 Applies to: Downtown
Last Revision Date: 2/16/15
Last Review Date: 2/16/15
Central Line Placement for EVD Patients
Procedure:
1. The steps below are considered to be an addendum to policy “CM C-34 Central Lines”
written specifically for a patient with Ebola. These steps are to be considered “helpful hints”
that should be discussed in detail with the clinical team prior to beginning the process.
A. Prep in the hallway of 8M. (Need counter and bedside table)
B. Pull out all equipment needed for procedure. (Drape, cvc kit, etc…)
C. Don sterile gloves
D. prep the bedside table with the max barrier kit
E. Take off gloves.
F. Don PPE
G. Make sure 3 claves are ready in the room.
H. Have 3 sterile saline flushes or a bowl with sterile saline to flush
I. Wait until in the room to open Central line container.
J. Bring Ultrasound sheath
K. Bring Sterile dressing
L. Bring into room the following: bedside table with max barrier kit, line kit, extra chloro
preps, sterile flushes, U/S machine with sheath cover and gel, 2 extra pair of sterile
gloves.
M. RN: Turn on u/s. Adjust contrast as needed.
N. At this point the Central Line Insertion and Removal procedure should be followed
Upstate Hospital EVD Guidance Downtown Campus Page 99 of 250
EVD Procedure
Procedure Issue Date: 2/16/15 Applies to: Downtown
Last Revision Date: 2/16/15
Last Review Date: 2/16/15
Chest X-Ray
Procedure:
1) The X-Ray Technologist will prepare the x-ray plate for use in the patient room: to be
performed in the cold zone.
a. The X-ray plate will be placed in three separate x-ray bags.
i. The first two bags will be rolled and sealed at the open end of the bag. The third,
outer bag will be rolled and sealed with a tabbed piece of duct tape positioned in the
center of the rolled/ sealed end of the bag.
ii. Once complete, the x-ray tech will provide the bagged x-ray plate to the Buddy while
standing in the cold zone.
iii. Radiology staff will ensure the tape and all folds of the bag will be placed on the side
of the x-ray plate that faces toward the bed. Nursing staff review with radiology
which side faces patient and which side faces the bed prior to entering the room.
2) The Buddy then hands the sealed plate to the Nurse in the patient room while standing
in the cold zone.
3) The Nurse in the patient room will(prep the bedside table with a blue wrap) accept the
x-ray plate, close the patient room door, place the plate on the bedside table and await
further instruction.
4) The Buddy will prepare the warm zone by providing a clean path of travel (clean zone)
for the x-ray machine and the x-ray technologist.
a. Wipe the warm zone floor from the clean zone with an approved disinfectant wipe on a
swiffer. Allow Disinfectant to dwell as directed by the trained observer. (2 mins)
i. Once complete, remove the disinfectant wipe and dispose of in the red bag (meeting
ASTM 1922 and ASTM1709 standards for 480 grams tear resistance and 165
grams of impact resistance.) waste container.
ii. Wipe swiffer with a separate disinfectant wipe.
iii. Wash hands with a separate disinfectant wipe.
b. While in the cold zone place a large blue wrap on the floor in the warm zone up to the
patient room door.
c. A second small blue wrap will be placed on the floor overlapping the large blue wrap up
to the corridor door. Use a third small blue wrap if necessary.
d. Once complete open the corridor door.
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5) The X-Ray Technologist will don a pair of nitrile gloves and roll the x-ray machine on
the blue wrap up to the patient room door. (the patient room door will remain closed at
all times until the x-ray unit and technologist have been removed from the area)
6) The Nurse will prepare the patient for the X-ray:
7) Don a 3rd
pair of nitrile gloves.
8) Raise the patient on the bed to a minimum 45% angle.
9) Move the patient bed away from the wall far enough to unplug the bed.
10) Unplug the bed and position the cord safely to prevent damage from the wheels or other
moving parts of the bed.
11) Clear the bed path of travel leading to the patient room door.
12) Move the patient bed directly in front of the patient room door.
13) Place the x-ray plate (black side to patient) with technologist guidance for proper
alignment.(side with the duct tape will face the bed)
14) Once aligned the Nurse will proceed to the patient room bathroom during x-ray.
a. In the event the patient is unstable and the nurse must remain with the patient
during the x-ray, the nurse will don a lead apron under the direction of the
Technologist.
15) When directed by the X-ray Technologist the Nurse will remove the x-ray plate and place
the bagged and sealed plate on the bed side table.
16) Return the patient to their original location keeping the bed out from the wall until the
bed has been plugged in. Once the bed is plugged in, push the bed back against the wall
and lower the patient on the bed.
17) The X-Ray Technologist removes the x-ray unit from the room.
18) X-ray plate hand off:
a. Buddy closes the corridor and Nurse open the patient room door
b. Nurse stands the x-ray plate up on the bedside table and wipes the outer plate bag
with the approved disinfectant. Allow for dwell time as directed by the trained
observer (2 mins)
c. Nurse carries the x-ray plate to the patient room door staying in the patient room.
d. Nurse lifts the tabbed duct tape from the bag, grabs the bagged plate in the middle on
both sides and slides the outer bag down exposing the two inner bags.
e. Buddy receives the x-ray plate from the nurse while standing in the cold zone careful
to grab the x-ray plate at the end touching the inner two bags only.
f. Nurse pulls the 3rd
outer bag away, places bag in the red bag (meeting ASTM 1922
and ASTM1709 standards for 480 grams tear resistance and 165 grams of impact
resistance.) waste container and wipes hands. Nurse closes patient room door. If 3rd
pair of outer gloves used remove the gloves at this point.
g. Once the patient room door is closed the X-ray Technologist donns a pair of nitrile
gloves and opens the corridor door.
h. Buddy grabs the bagged plate in the middle on both sides and slides the two inner
bags down exposing the plate. X-ray Technologist retrieves the plate careful not to
touch the x-ray bag and processes the x-ray panel to ensure the image is diagnostic.
i. Buddy disposes of the x-ray bag in the red bag (meeting ASTM 1922 and
ASTM1709 standards for 480 grams tear resistance and 165 grams of impact
Upstate Hospital EVD Guidance Downtown Campus Page 101 of 250
resistance.) waste container and wipes hands with approved disinfectant wipe. Allow
for dwell time as directed by the trained observer (2 mins). Buddy closes corridor
door.
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EVD Procedure
Procedure Issue Date: 2/16/15 Applies to: Downtown
Last Revision Date: 2/16/15
Last Review Date: 2/16/15
Highly Infectious Phlebotomy Protocol
Procedure: In-house patients identified as highly infectious will have phlebotomy performed by the in-house
care team.
1. Patient care personnel will perform the following actions prior to specimen collection:
a. Notify Security (4-4000) to report to patient room to provide escort for
Microbiology specimen transport personnel.
b. Confirm tests to be drawn then complete testing request paper work. (There are
downtime requisitions pre-completed for Ebola PCR, malaria PCR, and malaria
antigen tests for initial screening).
c. Obtain necessary specimen collection tubes.
d. If sending to Wadsworth complete NYSDOH Infectious Disease Requisition.
2. Microbiology/Core Lab personnel will report to the patient room with appropriate PPE
and specimen transport container once Incident Command has been activated.
(The following steps shall be read by Trained Observer)
3. Patient care personnel will proceed with specimen collection:
a. Don PPE in accordance with PPE Guidelines and enter patient room.
b. Retrieve specimen collection items stored in patient room, e.g. needle collection
device, alcohol pads, tourniquet, bleach wipes, labeling pen, and plastic transport
container (contains 3 EDTA tubes, 2 biohazard bags, and an absorbent pad), other
specimen collection tubes as needed.
c. Prep bedside table for blood draw. Place large bleach wipe on table. Open
specimen collection container. Open both biohazard bags and prop one of them
open inside of the collection container
d. Label the specimen tubes using permanent marker with patient name and DOB.
e. Follow routine phlebotomy patient identification procedure.
f. Collect specimens.
g. Discard phlebotomy materials.
h. Clean gloves with bleach wipe.
i. Decontaminate the shaft and rubber stopper of each specimen tube using a fresh
bleach wipe.
NOTE: there should be no visible contamination on the outside of the tube.
j. Place tubes into biohazard bag and seal.
k. Wipe outside of bag with bleach wipe.
Upstate Hospital EVD Guidance Downtown Campus Page 103 of 250
l. Place bagged tubes into second biohazard bag and seal. Wipe secondary bag with
bleach wipe.
m. Place the double-bagged specimen into the plastic transport container and
securely seal lid. The pass thru portal on 8m Room #2. Close door in room #2.
i. POC Lab door cannot be opened to remove specimen until door is closed.
n. Thoroughly clean outer surface of plastic container with a bleach wipe.
o. Place container on bleach wipe on table.
p. Clean gloves with bleach wipe then open door into warm zone by gripping door
handle with a bleach wipe.
q. Grip bottom of container and hand it to the buddy, positioning hand below
buddy’s hand.
4. Microbiology/ Core Lab will open anteroom door (note that only one door may be open
at a time, wait for door to room to be closed before opening the door from the hallway)
then buddy will place container into open cooler held by Microbiology personnel,
ensuring that no part of his/her body comes into contact with the cooler.
5. Nurse at the desk will provide all necessary paperwork as described above to
Microbiology/Core Lab personnel.
6. Specimens will then be transported to the lab on 8M.
7. If specimen is coming from a location other then 8M security will escort
Microbiology/Core Lab personnel to the laboratory on 8M following designated transport
route.
Upstate Hospital EVD Guidance Downtown Campus Page 104 of 250
EVD Procedure
Procedure Issue Date: 2/16/15 Applies to: Downtown
Last Revision Date: 2/16/15
Last Review Date: 2/16/15
Adult Continuous Renal Replacement Therapy (CRRT)
Number of Staff Needed: 2
Equipment: Alaris Pump for Heparin or Argatroban (per order)
Procedure:
1) Initiation of CRRT
2) 8M ICU Nurse Responsibilities a) Secure Equipment
i) 1- intravenous pump for Heparin or Argatroban (if ordered)
b) Obtain labs as indicated in the orders.
c) Weigh the patient, prior to starting the CRRT.
d) Send for Replacement Therapy Fluids and Heparin or Argatroban drips as ordered.
e) Establish baseline hemodynamic parameters prior to initiating and monitor the following for
stability:
i) EKG monitoring-continuous
ii) Arterial line-continuous or non-invasive BP (NIBP) at least q 15 minute readings during
initiation.
f) Secure documentation materials from CRRT chart/resource on unit (i.e. Troubleshooting
guidelines, Sample flow sheet, Dialysis flow sheet, and Physician’s orders).
3) Dialysis RN Responsibilities a) Dialysis RN will secure NxStage Dialysis Machine, set up and prime the system in Cold
Zone, including Replacement Therapy Fluids as ordered.
b) 8M RN will start the patient on the system. Dialysis RN will act as a resource to the ICU RN
in establishing the flow chart, maintaining the system, and in developing troubleshooting
skills from the Cold Zone.
4) Monitoring: Patient Care and Maintenance a) Responsibilities of the Dialysis RN
b) The set up for flushing the system should be labeled with the appropriate steps in a manner
(i.e.: 1-2-3, etc.) that clearly defines the process while in the Cold Zone.
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5) To deliver a fluid bolus: a) Note the fluid volume in the saline bag, then unclamp the saline “T” (red clamp) and the
saline line (white clamp).
b) When the desired saline volume is delivered, re-clamp the saline “T” (red clamp) and the
saline line (white clamp). During bolus a transient low venous pressure caution (20, 21) may
occur and should resolve after the bolus is delivered.
c) This additional saline must be considered when calculating fluid balance and ultra filtration
target. A bolus for hypotension should not be considered when calculating fluid balance and
ultra filtration target.
6) Daily assessment of CRRT system. a) The normal saline flush used by the dialysis RN is recorded as intake on ICU flow sheet by
8M ICU RN, NOT as a bolus. Document system change in EMR.
b) Responsibilities of the 8M ICU RN i) Monitor vital signs per orders. Observe the patient for signs of bleeding. Assess dialysis
catheter/site for bleeding, kinks. Change central line dressing as needed if wet or soiled.
ii) Establish baseline for pressures and vital signs for patient.
iii) Monitor treatment using the “Home” display screen on the One-View Monitor of the
NxStage CRRT machine.
iv) Address red alarms and yellow cautions immediately. See Troubleshooting.
v) Every hour ensure that there is enough Replacement Therapy Fluids available for the next
hour and that the bags are draining evenly. Check for air build up at top of filter/dialyzer
and remove air via post-filter cap port to reduce clot formation. Check therapy fluid
levels are topped off in “warmer bag”; purge excess air as needed. (See Troubleshooting).
vi) Call and communicate when Replacement Therapy Fluids order has changed to the
Pharmacy.
vii) If Replacement Therapy Fluid needs to be replaced, remove the used concentration fluid
and replace per order. Requires two (2) RNs to verify the Replacement Therapy fluid
with the physician's order.
viii) Document hourly in EMR. See Documentation section.
ix) Monitor and Document the following on an hourly basis:
(1) Total intake.
(2) Total output (NG drainage, urine output, CT drainage, JP drainage, or other drain
output.
(3) Therapy Fluid Flow, verify machine setting is consistent with physician order.
(4) Pressures - effluent and venous pressure.
(5) Blood pump speed.
(6) Heparin or Argatroban infusion rate.
(7) Circuit check. Filter/dialyzer and blood circuit clotting should be evaluated routinely
to identify early stages of clotting and plan interventions as needed to prevent further
clotting, potential blood loss or hemolysis. Evaluation of filter clotting may be done
by performing a fluid bolus. For the best visualization of the filter/dialyzer, occlude
the arterial (access) patient line (red clamp) just
Upstate Hospital EVD Guidance Downtown Campus Page 106 of 250
(8) before the saline “T” (red clamp) while saline is infusing. When flushing is complete,
release the arterial (access) patient line (red clamp) and re-clamp the saline line
(white clamp) and the saline “T” (red clamp). Record this fluid bolus as intake on
ICU flow sheet.
(9) In addition to RED ALARM 33.34 (Check filter: High TMP), and YELLOW
CAUTION 31, (Clotting Suspected: Check filter Clotting), Alarms and Cautions
indicating low venous (20and 21) or effluent pressure (22) may signal clotting of the
filter or blood circuit. One or more of these Alarms and Cautions indicate the need to
evaluate the blood circuit and filter for clotting.
c) Set/Change ml/hr (the amount drawn off each hour) i) Increase/Decrease UF rate volume by touching keypad, using adjustment arrows (up or
down) in Middle Window – yellow arrows) to modify the Ultrafiltration Rate
d) Set/Clear L/hr i) Touch green L/hr button adjustment arrows (up or down) in Upper Window, and set rate.
L/hr of Therapy Fluid is only changed by nephrologist order.
e) Flush the filter prn with 100 to 200 ml normal saline to assess for clotting as described
in step 9h above. Observe the filter for yellowing or darkening of the fibers. Document
filter appearance.
f) Monitor PTT and electrolytes per Heparin protocol and CRRT orders.
g) Weigh the patient BID. Weight should be at approximately the same times daily.
h) Notify the Nephrologists for the following: i) Systemic bleeding.
ii) System shut-down
iii) Hypotensive episode
i) For Acute Hypotensive Episode: i) Reduce ultra filtration rate down by either using the YELLOW ARROW or
ii) Press and hold red “STOP “button for 2 seconds to immediately reduce Therapy and
Ultrafiltration rates to “0” (after hypotension is treated, to return to previous rates), press
TREATMENT (green kidney shaped button).
iii) Give fluid bolus as ordered.
iv) Note fluid volume in saline bag, then unclamp the saline “T” (red clamp) and the saline
line (white clamp).
v) When the desired/ordered saline volume is delivered, reclamp the saline “T” (red clamp)
and the saline line (white clamp) NOTE: During the bolus, a transient LOW VENOUS
PRESSURE YELLOW CAUTION may occur and should resolve after the bolus is
delivered.
(1) Do not turn off the blood pump or disconnect the patient from hemofiltration unless
there is a blood leak in the system itself or a clot that is impeding flow, or patient
remains hypotensive after three- 200 ml boluses.
(2) Notify the Nephrologist.
7) Discontinuation and Returning Patient’s Blood a) Supplies:
i) NxStage System One’s User’s Guide
ii) Prep Pads
iii) 2 Multilumen dialysis catheter caps or red caps
iv) 2 vials-sterile normal saline 10 ml for injection or 2 10cc normal saline pre-filled
syringes.
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b) Sufficient volume of saline for rinseback
c) Heparin 1,000 units/ml, draw up volume of catheter ports plus 0.1 ml. (ex. If catheter port
volume is 2.1 ml, using 1,000 units/ml heparin, draw up 2.2 ml (2,200 units)) or Alteplase
(TPA) if ordered – 2 vials Alteplase (TPA), 1 vial sterile H20-reconstitute each TPA vial
with 2.2 ml sterile H20. Draw up port volume and instill briskly.
i) 2 -10 ml syringes
ii) 2 -3 ml syringes
d) One chux or other type barrier
8) Rinseback Procedure: a) Scrub the connection of the multilumen dialysis catheter and the arterial/venous lines with
prep pads using moderate friction. Allow the area to air dry at least 30 seconds
b) Clamp arterial /access monitor line (Label line #1) with blue clamp or booted hemostat.
c) Open normal saline line, both red and white clamps (Label line #2). Make sure there is a
minimum of at least 300ml in flush bag.
d) If blood pump is off, press “Stop” key, then the green kidney shaped “treatment” key to
restart pump (Label line #3).
e) Turn on the blood pump at a low blood flow rate (150 ml/min).
f) When all of the patient’s blood has been returned, turn off the blood pump by pressing the
“Stop” key.
g) Clamp the venous port of the multilumen dialysis catheter and the venous CRRT bloodline.
h) With the blood pump off, unclamp arterial blood line, letting normal saline flush back to the
arterial side blood by gravity.
i) Clamp the arterial CRRT blood line and arterial side of multilumen dialysis catheter.
j) Place mask on you and patient if non-ventilated. Disconnect the arterial blood tubing from
the arterial port of the catheter. Place 10 ml syringe of normal saline flush on dialysis catheter
which was just cleaned.
k) Unclamp the multilumen dialysis catheter on the arterial side and briskly flush with 10 ml
normal saline. Clamp the catheter. Attach 3 ml syringe with Heparin to arterial port of
dialysis catheter. Unclamp the catheter and briskly fill the arterial side lumen with the
appropriate volume of Heparin or TPA solution as ordered. Check CRRT orders for catheter
block orders. Re-clamp the catheter, remove the syringe, and cap the port aseptically.
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l) Repeat Steps 10 & 11 above for the venous blood tubing and the venous port of the catheter.
Note and document the time and reason for disconnection. Ensure the Nephrologist and
Dialysis Nurse are aware of the disconnection.
m) Once values are recorded from the One-View Monitor power off the machine by turning the
power switches to both the Cycler and Fluid Warmer OFF. Shut down the One View Monitor
by touching upper right corner of screen and then select “POWER OFF”.
n) Lift the front door handle of the Cycler up completely (until it clicks) and pull to open the
door.
o) Remove the disposables:
i) Disconnect the access pressure pod from the Cycler.
ii) Clamp and disconnect the Cartridge from the warmer disposable outlet.
iii) Clamp and disconnect the waste line from the waste line extension.
iv) Remove the saline bag and Cartridge and discard per hospital protocol.
v) Open the Fluid Warmer door and remove the warmer disposable/therapy MLA and
discard appropriately.
vi) Call Dialysis Nurse to discard the blood lines and filter in contaminated trash bag.
9) Alternative Rinseback Method: a) Press and hold STOP for 2 seconds. “000” will appear in the YELLOW Caution Window.
The Therapy Fluid and Ultrafiltration rates go to “0” and the Blood Pump continues.
b) Press STOP to stop the blood pump.
c) Verify rinseback display.
d) Clamp and disconnect the arterial (access) patient line (red clamp), reconnect it to the
priming spike (red port), then unclamp.
e) Press ADD FLUID to begin returning the blood (observe “210” in the top window, counting
down to “0”).
f) When rinseback is complete, clamp and disconnect the venous (return) patient line (blue
clamp) from the patient’s vascular access.
g) Turn the power switches to both the Cycler and the Fluid Warmer OFF.
h) Lift the front door handle of the Cycler up completely (until it clicks) and pull to open the
door.
i) Remove the disposables:
i) Disconnect the access pressure pod from the Cycler.
ii) Clamp and disconnect the Cartridge from the warmer disposable outlet.
iii) Clamp and disconnect the waste line from the waste line extension.
iv) Remove the saline bag and Cartridge and discard per hospital protocol.
v) Open the Fluid Warmer door and remove the warmer disposable/therapy MLA and
discard appropriately.
10) Manual Rinseback a) Termination of the treatment in the event of a power failure or unrecoverable alarm.
i) Make sure enough saline is available to rinse back the blood.
ii) Turn the power switches to both the Cycler and Fluid Warmer OFF.
iii) Clamp the waste line (yellow clamp) and therapy fluid inlet (green clamp).
iv) Clamp and disconnect the arterial (access) patient line (red clamp), reconnect to the
priming spike (red port), then unclamp.
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b) Lift the front door handle of the Cycler up completely ( until it clicks) and pull toward you to
open cycler door.
c) Squeeze the saline bag until patient lines have rinsed clear. If pressure/ resistance exists, or
air is present in the venous (return) patient line (blue clamp). DO NOT attempt to rinseback.
d) Clamp and disconnect the venous (return) patient line (blue clamp) from the patient’s
vascular access.
e) Remove the disposables:
i) Disconnect the access pressure pod from the Cycler.
ii) Clamp and disconnect the Cartridge from the warmer disposable outlet.
iii) Clamp and disconnect the waste line from the waste line extension.
iv) Remove the saline bag and Cartridge and discard appropriately.
v) Open the fluid warmer disposable/therapy MLA and discard appropriately.
11) Temporary Disconnection a) The following procedure can be used to recirculate the extracorporeal circuit after returning
blood to the patient for periods when the patient needs to be off CRRT for testing such as CT
Scans, MRI, etc. The system can recirculate for a period up to two hours.
b) To Temporarily Disconnect Patient
i) Complete rinseback of blood to patient as per Section IV above. (NOTE: If clotting is
present, discard the cartridge/filter and call Dialysis Nurse to set up new CRRT system.)
ii) Attach the arterial (access) patient line (red clamp) to the priming spike (red port/clamp).
Unclamp both clamps.
iii) Attach the venous (return) patient line (blue clamp) to the priming spike (blue
port/clamp). Unclamp both clamps.
iv) Press green TREATMENT key to recirculate the blood circuit with saline.
v) Immediately set the rates using the ADJUSTMENT ARROWS on cycler.
vi) Dialysate Rate: green arrows (Top Window) – set to 0.1
vii) Ultrafiltration Rate: yellow arrows (Middle Window) – set to 0
viii) Blood Flow Rate: red arrows (Bottom Window) – set to 300 – 350
(1) When patient is to be reconnected, clean catheter access ports using prep pads or
similar hospital approved item. Press STOP key, clamp and disconnect the patient
lines from the priming spike, then reconnect to patients vascular access and unclamp.
(2) Press TREATMENT key and re-enter the ordered therapy parameters to resume
therapy.
12) Resetting the access pressure pod a) Procedure
i) Detach the access monitoring line from the Cycler, and observe the access pressure pod
deflate (bottom out).
ii) Press STOP.
iii) Clamp the arterial (access) patient line (red clamp).
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iv) Unclamp the saline line (white clamp) and the saline “T” (red clamp) and observe the
diaphragm filling with blood. When it is full, clamp the saline line (white clamp), saline
“T’ (red clamp) and the access pressure pod monitoring line (red clamp).
v) Unclamp the arterial (access) patient line (red clamp).
vi) Press TREATMENT.
vii) Attach the access pressure pod monitoring line, by holding the line behind the locking
collar and inserting the tip into the connection point until it stops. While maintaining firm
pressure, twist the tip ¼ turn counterclockwise (to properly seal the connection), then
tighten the locking collar.
viii) Unclamp the access pressure pod monitoring line (red clamp).
ix) Confirm that the arterial (access) pressures are within range.
x) Check Blood Circuit: Pressure Alarms
xi) Red Alarm “20, 21, 22, 23, 24, 30, 31, 33, 34, 35”
b) In electronic medical record (EMR) documentation flow sheet Continuous Renal
Replacement Therapy Flow sheet (CRRT)
i) A new flow sheet is initiated and dated for each 24-hour period. Flow sheets must include
patient identification information from stamped patient nameplate or printed forms.
ii) The CRRT flow sheet should be placed in the patient’s chart.
iii) The desired net fluid loss is an ordered amount by the nephrologist on the order sheet.
This is documented in the appropriate column at the start of each hour.
iv) The CRRT Flow sheet intake and output section will reflect all fluids administered to the
patient, except IVF bolus received for hypotension and all output removed from the
patient. It will also reflect the calculated output, labeled CRRT real fluid loss/UF
Removed.
v) Document the following in an hourly basis:
(1) Total Intake and Output
(2) Pressures effluent, and venous
(3) Therapy Fluid Rate (ordered)
(4) Blood pump speed/rate
(5) Heparin or Argatroban infusion rate, when ordered.
c) Circuit check - Air Trap/Warmer i) In EMR
(1) Record VS/Temperature as ordered/indicated.
(2) Weight and time are recorded prior to treatment then every 12 hours at set times,
unless ordered otherwise.
(3) Rate of Heparin or Argatroban is recorded in the Drip section.
(4) The ICU Flow sheet intake and output section will reflect all fluids administered to
the patient, and all output removed from the patient. It will also reflect the calculated
output, labeled CRRT real fluid loss UF Removed.
(5) See CRRT/ Flow sheet: Guidelines for completion.
(6) Trouble shooting, Yellow and Red alarms put into tables Appendix A, B, C Refer to
Procedure C-28A
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Procedure
Procedure Issue Date: 2/16/15 Applies to: Downtown
Last Revision Date: 2/16/15
Last Review Date: 2/16/15
Galileo Mechanical Ventilator
Procedure:
1) Ebola Procedure: The Respiratory Therapist will communicate with the Doctor/Nurse
working in the –patient room to perform the necessary steps below to use the Galileo
Ventilator to make the following settings. The Respiratory Therapist will communicate while
monitoring outside via the video to assure that each step is performed correctly
2) Mechanical Ventilation Mode and Tidal Volume
a) Patients will be ventilated using Volume cycled assist control at a tidal volume of 6-ml/kg
ideal body weight (IBW).
3) Ventilator Rate
a) Initial ventilator rate will be set to match the expected minute ventilation based upon
(a) normal needs of rate times tidal volume. Typical rate would be set at 10-14.
b) Adjustments to ventilator rate and tidal volume will be adjusted to achieve Arterial pH
goal of 7.20 pH<= 7.45.
c) Plateau Pressure goals <=30 cm H2O.
4) Inspiratory Flow and I:E Ratio
a) Inspiratory flowrate will be adjusted to maintain the I:E ratio = 1:1.0 – 1:3.0
5) Oxygenation
a) The oxygenation target range is 55 mm Hg <= PaO2 <= 80 mm Hg or 88% <= SpO2- sat
<= 95%. When both PaO2 and SpO2 are available simultaneously, the PaO2 criterion will
take precedence.
b) Levels of PEEP may be used to keep airways open as needed.
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Microbiology Procedure
Section 110 : Select Agents Number: 110.5.9
Part 5 : Identification
No. 9 : Viral Hemorrhagic Fever (VHF) 8/20/14 DLK
_____________________________________________________________________________
Revised Date: Change Description:
8/19/16 SWR Modified donning/doffing using PAPR; updated bleach kill
times; updated Appendix 13
I. Principle:
The following guidance is for Microbiology-specific processing
and testing of specimens from patients with suspected viral
hemorrhagic fever (VHF). Specifically, this document provides
guidance for packaging and shipping of blood specimens to NYSDOH
and for malaria antigen performed in-house.
II. Background:
A. VHF is caused by members of four different viral families,
including Arenaviridae, Filoviridae, Bunyaviridae, and
Flaviviridae (see table). Person-to-person transmission
occurs through direct contact (through broken skin, mucus
membranes) with infected blood or body fluids or objects
contaminated with infected fluids.
Ebola Chapare Nanjianyin Nairovirus
Marburg Guanarito Omsk Hantavirus
Lassa Sabia Crimean Congo Yellow Fever
Junin Whitewater Arroyo Rift Valley Kyasanur Forest
Machupo Phlebovirus Dengue Alkhumra
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III. VHF-specific Testing:
A. Providers must contact the Onondaga County Health
Department (OCHD) to discuss the case and to seek approval
for testing at (315)435-3256 (after hours, 315-682-7068
Quoc Nguyen, M.D.).
1. If unable to reach OCDC, providers can contact the
NYSDOH Bureau of Communicable Disease Control at
(518)473-4439 during business hours or the NYSDOH
Public Health Duty Officer at 1-866-881-2809
evenings, weekends, and holidays.
B. If approval for testing is given, public health officials
will provide guidance for specimen collection, handling,
and transport. The laboratory will be notified (S.R. and
S.L.) once Incident Command has been activated.
C. Tests Available for Ebola virus at CDC (similar testing
available for other VHF agents):
TIMELINE OF INFECTION DIAGNOSTIC TESTS AVAILABLE
Within a few days after
symptoms begin
Antigen-capture enzyme-linked
immunosorbent assay (ELISA)
testing
IgM ELISA
Polymerase Chain Reaction (PCR)
Virus isolation
Later in disease course or
after recovery
IgM and IgG antibodies
Retrospectively in deceased
patients
Immunohistochemistry testing
PCR
Virus isolation
D. Tests available for Ebola virus at NYSDOH: Real-time RT-PCR
1. Performed 24/7 for approved cases.
2. Samples will be transported 24/7 using DOH resources
according to NYSDOH Critical Specimen Transport
Program (Appendix 2). OCHD will initiate the CST
process.
a. OCHD will provide the Incident Command phone
number (315-464-4888) to the CST dispatcher and
courier.
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b. The courier will park in the traffic circle at
the front entrance of the hospital, stay in
their vehicle, call the number, and provide
their name and a description of their vehicle.
c. Incident Command will notify University Policy
of their presence.
d. All specimens will be packaged as Category A
Infectious Substances according to DOT
regulations.
e. Microbiology trained personnel will deliver the
packaged specimen to the courier and will
verify the courier's NYSDOH identification.
3. Expected turnaround time (specimen pickup to report):
6-12 hours.
4. Malaria PCR automatically performed immediately after
a. Negative Ebola PCR.
b. Results available 3-5 hours after the Ebola
report.
E. Specimen Collection:
1. For patients with suspected VHF, the following
samples will be collected.
a. 3 completely filled EDTA (lavender top) tubes
b. Ebola PCR, malaria PCR, and malaria antigen
will be requested using a downtime requisition.
c. A completed NYS Infectious Disease Requisition
will accompany the specimens.
2. For patients with confirmed VHF and suspected
bacteremia, blood specimens for culture will be
collected according to institutional guidelines based
on patient weight (Policy CM B-08).
a. Only plastic blood culture bottles will be
used.
b. For patients weighing less than 13 kg, a single
adult aerobic bottle will be used.
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IV. Definitions:
A. Work Zones:
1. Hot Zone (laboratory):
a. Defined by red tape.
b. Contains Ebola (or suspected) infectious waste.
2. Warm Zone:
a. Defined by yellow tape.
b. Designated area between hot and cold zones used
for doffing.
3. Cold Zone (anteroom):
a. Defined by green tape.
b. Clean area with no infectious waste.
B. Personnel:
1. Care Provider:
a. Physician or nurse who cares for patient.
2. Buddy:
a. Clinical staff who observes and assists with
donning and doffing process as necessary.
3. Trained Observer:
a. Person calling out each step in the donning and
doffing process.
4. Assistant:
a. Laboratorian who assists processor and packages
specimen.
5. Processor:
a. Laboratorian who prepares specimen for shipping
and performs malaria antigen testing.
V. Personal Protective Equipment (PPE):
Upstate Hospital EVD Guidance Downtown Campus Page 117 of 250
A. Only properly trained individuals will be permitted to
handle specimens from suspected or confirmed VHF patients.
B. Laboratory personnel will receive initial and biannual
refresher training regarding PPE donning and doffing.
C. Packs containing necessary PPE are pre-positioned and
include the following:
1. Full gown (Thumbs Up Isolation gown)
2. Knee-length boot covers
3. Outer pair of gloves (purple nitrile extended cuff)
4. Inner pair of gloves (blue nitrile)
5. Scrubs
6. Crocs
NOTE: Additional stocks of these items are available on 8M.
D. Powered Air Purifying Respirator (PAPR) – all components
are pre-positioned in the 8M laboratory.
E. PPE donning and doffing will be observed and documented
using a buddy and trained observer.
VI. Specimen Transport:
A. Microbiology personnel will be notified by Incident Command
when specimen collection/testing is required.
1. Emergency Room:
a. Microbiology trained personnel will bring the
VHF specimen transport cooler to the ER. PPE
for transport will consist of hospital scrubs,
crocs, a disposable blue lab coat and gloves.
b. Microbiology trained personnel, with a security
escort, will transport the specimens, completed
downtime requisition, and completed NYS
Infectious Disease Requisition from the ER to
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the 8M laboratory anteroom. The lab coat and
gloves will be discarded in red trash can.
c. The specimen transport cooler and paperwork
will remain in the anteroom while the transport
person dons full PPE (VII).
d. The transport person (in full PPE) will open
the cooler in the anteroom, remove the specimen
container, close the cooler, and proceed into
the laboratory with the specimen container.
NOTE: If the specimen spilled/leaked while in
transport, immediately close the cooler and
proceed into the laboratory with the cooler.
See Appendix 3 for cooler cleaning protocol.
2. 8M Unit:
a. Microbiology trained personnel wearing full PPE
(VII) will report to the 8M laboratory.
b. Specimen will be received in pass through
portal.
VII. Donning PPE - Processor and Assistant (Private area/Room 8138):
A. Pre-Donning Procedure:
1. Remove all personal clothing and jewelry.
2. Put on hospital scrubs and clogs and proceed to 8M –
see also VI and VIII.
3. Remove ID badge.
3. Tuck pant legs into socks and shirt into pants.
4. Verify PAPR unit assembly
a. Inspect breathing tube, connections, and body
(look for gaskets, check for breaks in tube,
check threading of filters and PAPR).
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b. Inspect filters/cartridges for correct
installation
c. Ensure battery is fully charged.
5. Verify PAPR air flow
a. Check that the correct filter is used.
b. Insert air flow indicator into blower opening
on top of PAPR.
c. Turn on blower.
d. Plastic cone of air flow indicator should rise
above the minimum flow mark.
e. If indicator does not reach minimum flow mark,
check battery and ensure that filter and
cartridge caps have been removed.
6. Inspect PAPR hood assembly
a. Check that breathing hose thread gasket seal is
present.
b. Check that thread in blower unit is in good
condition and is clear of foreign matter.
c. Screw end of breathing hose onto blower unit
until hand tight. Do not over-tighten.
d. Connect tube to headpiece, screw on end of
breathing hose until it is hand tight.
7. Check vials of Processor, Assistant, and Buddy.
8. Inspect PPE for rips or tears.
B. Donning Procedure
1. Put on knee-length boot covers.
2. Put on first pair of nitrile gloves (blue).
3. Put on Thumbs Up Isolation gown and tie.
4. PAPR unit
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a. Buddy holds the blower unit and helps secure
belt, ensuring the belt holders are secured in
place. Adjust belt as needed.
b. Buddy turns on the blower motor.
c. Place hood over the head and pull chin strap to
snug under chin.
5. Put on second pair of nitrile gloves (purple extended
cuff).
6. No exposed skin or hair should be visible.
NOTE: once Hot Zone door is closed, Buddy will don
appropriate PPE and place blue wrap on counter in warm
zone.
VIII. Preparatory Steps:
A. Assistant:
1. Retrieve the following items and proceed to 8M.
a. Cold pack from freezer in 3818C.
b. Malaria antigen kit in walk-in refrigerator
(Room 3719).
c. PPE pack for transport person.
d. PPE pack for yourself.
2. Don full PPE (VII) and enter 8M laboratory anteroom.
3. Open shipping box and remove shipping container.
Remove blue foam square and insert cold pack.
4. Line red trash can in anteroom with 2 red biohazard
bags.
5. Bring shipping container, 2 malaria antigen test
cards and Reagent A into laboratory.
6. Cover top of cart with a blue absorbent pad and place
the following items on pad:
a. pipettor
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b. pipette tips
c. timer (in zip-lock bag, pre-set to 15 minutes)
d. BinaxNOW card
e. gauze
f. Binax Reagent A
g. purple gloves
h. shipping container
7. Place a blue absorbent pad, small bleach wipes,
gauze, alcohol bottle, and rack in BSC.
8. Pour 500 mL of Chlorox Healthcare bleach in measuring
cup, and then into urine container. Place container
under BSC.
9. Position white plastic bucket near BSC and line with
a red biohazard bag.
10. Line the large red trash can with 2 red biohazard
bags.
IX. Packaging:
A. Processor - 8M Specimens:
1. Place specimen bag in BSC on blue absorbent pad.
2. Wipe surface of outer bag using a small bleach wipe.
a. Discard wipe into urine container.
b. Wait 1 minute for bleach kill time.
3. Open both bags carefully and inspect contents for
leakage or contamination.
NOTE: If this has occurred, close the bags and do not
process. Discard entire contents into lined white
bucket. Request repeat sample collection.
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4. Remove one tube from inner bag and place in rack for
malaria antigen.
5. Re-seal bags, minimizing trapped air.
a. Wipe surface of outer bag using a small bleach
wipe.
b. Place bag on metal surface of BSC.
6. Discard wipe into urine container.
7. Remove outer gloves and discard into urine container.
8. Put on a clean pair of extended cuff gloves.
9. Insert specimen bag into shipping container.
a. Close the lid tightly.
b. Wipe outer surface of shipping container using
a small bleach wipe.
c. Discard wipe into urine container.
d. Wait 1 minute for bleach kill time.
10. Give shipping container to assistant.
a. Assistant will place shipping container on
table near door.
11. Proceed with malaria antigen test.
a. Assistant will read Malaria Antigen Procedure
steps to processor.
B. Processor - Emergency Room Specimens:
1. Place specimen container in BSC on blue absorbent
pad.
2. Wipe outer surface of specimen container using a
small bleach wipe.
a. Discard wipe into urine container.
b. Wait 1 minute for bleach kill time.
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3. Open specimen container carefully and inspect
contents for leakage or contamination.
NOTE: If this has occurred, close the container and
do not process. Discard entire contents into lined
white bucket. Request repeat sample collection.
4. Remove double biohazard bag containing the specimens.
5. Remove one tube from inner bag and place in rack for
malaria antigen.
6. Re-seal bags, minimizing trapped air.
a. Wipe surface of outer bag using a small bleach
wipe.
b. Place bag on metal surface of BSC.
7. Discard wipe into urine container.
8. Seal specimen container and discard into lined white
bucket.
9. Remove outer gloves and discard into urine container.
10. Put on a clean pair of extended cuff gloves.
11. Insert specimen bag into shipping container.
a. Close the lid tightly.
b. Wipe outer surface of shipping container using
a small bleach wipe.
c. Discard wipe into urine container.
d. Wait 1 minute for bleach kill time.
12. Give shipping container to assistant.
a. Assistant will place shipping container on
table near door.
13. Proceed with malaria antigen test.
a. Assistant will read Malaria Antigen Procedure
steps to processor.
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X. BinaxNOW Malaria Antigen (Processor):
A. Place pipettor, pipette tips, one BinaxNOW card, and
BinaxNOW Reagent A in BSC.
B. Wipe outside of blood tube with a small bleach wipe.
Discard wipe in urine container. Wait 1 minute for bleach
kill time.
C. Mix sample by gently inverting the tube several times.
D. Remove stopper using gauze.
1. Lay stopper face up on top of gauze on blue absorbent
pad.
2. Place tube in specimen rack and clean gloves with a
small bleach wipe.
3. Discard wipe in urine container.
4. Wait 1 minute for bleach kill time.
E. Open Binax card and lay flat.
F. Pre-rinse the pipette tip and then slowly add 15 µL of
blood to the bottom half of the PURPLE sample pad. Eject
pipette tip into urine container.
IMPORTANT: Incorrect addition of sample may lead to an invalid or
uninterpretable test.
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G. There is a white pad immediately below the purple sample
pad.
1. Hold the Reagent A bottle vertically 1/2 inch above
this pad and add three (3) free-falling drops.
2. Allow the first drop to absorb into the pad before
adding the second drop.
3. Do NOT add Reagent A directly to the purple pad.
4. Re-cap tube with stopper.
a. Discard gauze in urine container.
b. Wipe tube with a small bleach wipe and place in
rack until test is complete.
c. Discard wipe in urine container.
H. Allow the blood sample to run up the full length of the
test strip.
1. Do not allow the blood to run into or under the
absorbent pad at the top of the strip, as doing so
will hinder optimal washing (clearance) of the test
strip.
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I. Just before the blood sample reaches the base of the white
absorbent pad located at the top of the test strip, SLOWLY
add four (4) free-falling drops of Reagent A to the wash
pad on the top left-hand side of the test device, allowing
each drop to absorb into the pad before adding the next.
NOTE: The third and fourth drops may not completely absorb
into the pad.
J. When the sample just reaches the base of the white
absorbent pad at the top of the test strip, remove the
adhesive liner from the right edge of the device, and close
the device.
1. This allows the Reagent A to wash (clear) the blood
sample off the test strip.
2. To ensure good device closure and test flow, press
very firmly along the entire edge to the right of the
result window.
K. Set timer for 15 minutes.
L. Read the test result through the viewing window 15 minutes
after closing the test device.
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1. Results read before 15 minutes may be incorrect.
2. Tilting the device may reduce glare and facilitate
interpretation.
M. Valid Test Results:
1. The Control (C) line will appear on all valid tests
and, when it is present, test results are interpreted
as follows:
a. Note that the appearance of any Test (T) line,
even when very faint, indicates a positive
result.
b. See table on next page for interpretation. See
108.8.4 for reporting.
TEST RESULTS DESCRIPTION/INTERPRETATION
T1 (HRPII)
Positive
Positive result for P. falciparum
T2 (aldolase)
Positive
Positive result for P. vivax or P.
malariae or P. ovale. In some
cases the appearance of only T2
Line may indicate a mixed infection
with two or more of these species.
T1 & T2
Positive
Positive result for P. falciparum.
In some cases the appearance of
both T1 and T2 Lines may indicate a
mixed infection of P. falciparum
with another species.
No T1 or T2
Lines
Negative result (no malaria
antigens were detected)
Invalid and/or
Uninterpretable
The test is invalid if the Control
(C) Line does not appear, whether a
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Test Results
Test (T) Line(s) is present or not.
The test is uninterpretable if the
background color hinders reading of
the test result at 15 minutes.
Invalid or uninterpretable tests
can occur due to improper sample or
Reagent A addition. Consult the
Test Procedure Section and
Precaution #5 before repeating
testing with a new device. Call
Technical Service if the problem
persists.
N. Discard blood tube in urine container.
O. Roll up Binax card in blue absorbent pad and discard in
lined white bucket.
P. Decontaminate outer surface of pipettor, pipette tip box,
rack, and Reagent A bottle with small bleach wipes.
1. Discard wipes in urine container.
2. Wait 1 minute for bleach kill time.
Q. Remove residual bleach using alcohol-soaked gauze.
1. Place items on cart as they are cleaned and discard
gauze into urine container.
R. Decontaminate BSC work surface with a small bleach wipe and
discard wipe in urine container.
S. Remove residual bleach using alcohol-soaked gauze. Discard
gauze in urine container.
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T. Decontaminate outer surface of wipe container and alcohol
bottle with small bleach wipes.
1. Discard wipes in urine container.
2. Leave wipes and alcohol under hood.
U. Seal urine container tightly, wipe with a small bleach
wipe, and discard both in lined white bucket.
V. Decontaminate outer pair of gloves with a small bleach
wipe.
1. Wait 1 minute for bleach kill time.
2. Remove outer gloves and discard along with wipe into
lined white bucket.
W. Put on a clean pair of extended cuff gloves.
X. Place items back into cart and discard blue absorbent pad
into lined white bucket.
Y. Proceed with waste handling and doffing as in XI.
Z. Assistant:
1. When malaria antigen is completed, proceed with
doffing (first out) (X1).
2. Wash hands with soap and water.
3. In anteroom, put on a clean pair of gloves.
4. Insert shipping container into box.
5. Place the foam lid over the top of the slotted foam
block.
6. Fold the top of the plastic liner into place.
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7. Insert NYS Infectious Diseases Requisition into a zip
lock bag and place inside shipping container on top
of plastic liner.
8. Close the box, folding the front flap in first.
9. Complete the Shipper's Declaration of Dangerous Goods
Form per example (Appendix 1).
10. Insert Dangerous Goods Form into FedEx pouch.
Reserve one copy of form.
11. Secure lid with packing tape.
12. Attach pouch to box.
13. When laboratory door is closed, step into hallway
with shipping box and Specimen Log (Appendix 4).
14. Place box and log on counter.
15. Change into a clean pair of scrubs.
16. Take box and Specimen Log to front entrance of
hospital.
17. Give box to CST courier and complete Specimen Log.
XI. Doffing PPE:
A. First Out:
1. Wave at ceiling camera to alert buddy/trained
observer.
2. Open folding chair and position near warm zone.
3. Wipe gloves with a large bleach wipe and discard wipe
in red trash can. Wait 1 minute for bleach kill
time.
4. When buddy arrives, signal intention to exit the lab
with the "thumbs up" sign.
5. Sit in chair.
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a. Remove boot cover from left foot without
touching gloves to pants.
b. Place left foot on floor in warm zone and
discard boot cover in red trash can.
c. Repeat process for right foot.
6. Stand up (assistant should steady chair if needed).
7. Wipe gloves with a large bleach wipe and discard.
Wait 1 minute for bleach kill time. Discard outer
gloves.
a. Pinch glove near cuff.
b. Roll the glove inside out and discard in trash
can.
c. Insert finger inside the cuff of the remaining
outer glove, pull inside out, and discard in
trash can.
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8. Use a clean wipe to open door with left hand
a. Pass shipping container to buddy in anteroom.
b. Enter anteroom and discard wipe in anteroom
trash can.
c. Buddy will place shipping container on blue
wrap on counter in anteroom and wipe gloves
with a bleach wipe.
9. Turn around so that PAPR is facing Buddy.
a. Buddy grasps blower unit and staff unbuckles
belt.
b. Buddy disconnects air hose connected to the
hood, places unit on blue wrap on counter, and
turns power off.
c. Buddy wipes down PAPR with a large bleach wipe
and leaves unit on blue wrap on counter.
10 Lean forward and remove hood into red trash can.
11. Wipe gloves with a large bleach wipe. Discard wipe
in trash can. Wait 1 minute for bleach kill time.
11. Pull gown at waist to break tie.
12. Cross arms to shoulders, pinch gown and pull outward.
Turn gown inside out, roll it up, and place in trash
can.
13. Wipe blue gloves with a large bleach wipe. Discard
wipe. Wait 1 minute for bleach kill time.
14. Remove blue pair of gloves.
a. Pinch glove near cuff.
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b. Roll the glove inside out and discard in trash
can.
c. Insert finger inside the cuff of the remaining
outer glove, pull inside out, and discard in
trash can.
15. Wash hands with soap and water.
16. Put on a clean pair of gloves and place shipping
container into box.
a. Remove gloves.
b. Wash hands with soap and water and complete
packaging process.
c. Remain in anteroom until laboratory door is
closed.
B. Last Out and Waste Removal:
1. Add ~1 cup of Chlorox Healthcare bleach to red
biohazard bag in white plastic bucket to saturate
items.
2. Lift bag away from your body, taking care not to
touch the inside of the bag.
3. Grab the bag just above the level of the waste and
twist the top section. Try to minimize the amount of
incorporated air.
4. Bend the twisted top over.
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5. Carefully place the zip tie around the twisted bag
and pull to close.
6. While holding the bag, wipe the outside of the bag
with a large bleach wipe. Discard wipe in red trash
can.
7. Place bag into red trash can.
8. Add ~1 cup of Chlorox Healthcare bleach to red trash
can waste to saturate items
9. Wipe gloves with a large bleach wipe and discard in
red trash can. Wait 1 minute for bleach kill time.
10. Signal buddy and trained observer intention to exit
the lab with the "thumbs up" sign.
11. Sit in chair.
a. Remove boot cover from left foot without
touching gloves to pants.
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b. Place left foot on floor in warm zone and
discard boot cover in red trash can.
c. Repeat process for right foot.
12. Stand up.
13. Lift inner bag of red trash can away from your body,
taking care not to touch the inside of the bag.
14. Grab the bag just above the level of the waste and
twist the top section. Try to minimize the amount of
incorporated air.
15. Bend the twisted top over.
16. Carefully place the zip tie around the twisted bag
and pull to close.
17. While holding the bag, wipe the outside of the bag
with a large bleach wipe. Discard wipe in red trash
can.
18. Place bag back into red trash can.
19. Use a clean wipe to open door with left hand until
door stays in open position. Discard wipe in red
trash can.
20. Lift the outer red bag of red trash can, holding it
away from your body.
21. Grab the red bag just above the level of the waste
and twist the top section. Try to minimize the
amount of incorporated air.
22. Bend the twisted top over.
23. Carefully place the zip tie around the twisted bag
and pull to close.
24. While holding the bag, wipe the outside of the bag
with a large bleach wipe.
25. Hand bag to buddy for disposal in RMW container, then
discard wipe in red trash can in anteroom.
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26. Wipe gloves with a large bleach wipe. Discard wipe
in red trash can in anteroom. Wait 1 minute for
bleach kill time.
27. Close laboratory door by pushing on laboratory side
of door.
a. Do not touch outer (anteroom) side.
b. Keep door closed until RMW waste is removed
from anteroom.
NOTE: Packager should leave the anteroom at
this time.
28. Use a clean wipe to open door with left hand and walk
into anteroom. Discard wipe in anteroom trash can.
29. Turn around so that PAPR is facing Buddy.
a. Buddy grasps blower unit and staff unbuckles
belt.
b. Buddy disconnects air hose connected to the
hood, places unit on blue wrap on counter, and
turns power off.
c. Buddy wipes down PAPR with a large bleach wipe
and leaves unit on blue wrap on counter.
30 Lean forward and remove hood into red trash can.
31. Wipe gloves with a large bleach wipe. Discard wipe
in trash can. Wait 1 minute for bleach kill time.
32. Pull gown at waist to break tie.
33. Cross arms to shoulders, pinch gown and pull outward.
Turn gown inside out, roll it up, and place in trash
can.
34. Wipe blue gloves with a large bleach wipe. Discard
wipe. Wait 1 minute for bleach kill time.
35. Remove blue pair of gloves.
Upstate Hospital EVD Guidance Downtown Campus Page 137 of 250
a. Pinch glove near cuff.
b. Roll the glove inside out and discard in trash
can.
c. Insert finger inside the cuff of the remaining
outer glove, pull inside out, and discard in
trash can.
36. Wash hands with soap and water.
37. Put on clean glove and transport specimen cooler to
Microbiology Laboratory for cleaning (Appendix 3).
XII. Blood Cultures:
NOTE: The following procedure is used for patients with proven
VHF. For those patients who test negative for VHF, use routine
blood culture protocol (see Section 105).
A. BACTEC Instrument Loading:
1. Specimens will be received via pass-through portal.
2. Specimens will be processed using the buddy system.
3. ASSISTANT:
a. Line red trash can in anteroom with 2 red
biohazard bags.
b. Place a blue absorbent pad, small bleach wipes,
gauze, and alcohol bottle in BSC.
c. Pour 500 mL of Chlorox Healthcare bleach into
measuring cup and then into urine container.
Place urine container under BSC.
d. Position white plastic bucket near BSC and line
with a red biohazard bag.
e. Line the large red trash can with 2 red
biohazard bags.
f. Cover cart with blue absorbent pad.
4. PROCESSOR:
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a. Place bagged bottles in BSC on blue absorbent
pad.
b. Wipe surface of outer bag using a small bleach
wipe.
(1) Discard wipe into urine container.
(2) Wait 1 minute for bleach kill time.
c. Open inner bag carefully and inspect contents
for leakage or contamination.
NOTE: If this has occurred, close the bags and
do not process. Discard entire contents into
lined white bucket. Request repeat sample
collection.
d. Remove bottles from bags and discard bags in
urine container.
e. Wipe outer surface of bottles with a small
bleach wipe and place bottles on metal surface
of BSC.
(1) Discard wipe in urine container.
(2) Wait 1 minute for bleach kill time.
f. Remove residual bleach using alcohol-soaked
gauze and place bottles in rack on cart.
Discard gauze into urine container.
(1) ASSISTANT: Load bottles into
instrument(see 110.11.2).
g. Roll up blue absorbent pad and discard into
lined white bucket.
h. Decontaminate BSC work surface with a small
bleach wipe and discard wipe in urine
container.
(1) Wait 1 minute for bleach kill time.
i. Remove residual bleach using alcohol-soaked
gauze. Discard gauze in urine container.
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j. Decontaminate outer surface of wipe container,
and alcohol bottle.
(1) Discard wipes into urine container.
(2) Wait 1 minute for bleach kill time.
k. Remove residual bleach using alcohol-soaked
gauze.
l. Seal urine container tightly, wipe with a small
bleach wipe, and discard both in lined white
bucket.
m. Discard blue pad from cart into lined white
bucket.
n. Decontaminate outer pair of gloves with a small
bleach wipe.
(1) Discard wipe into lined white bucket.
(2) Wait 1 minute for bleach kill time.
o. Remove outer gloves and discard into lined
white bucket.
p. Put on a clean pair of extended cuff gloves.
q. Proceed with waste handling and doffing as in
XI.
B. BACTEC Instrument Positives:
1. When the BACTEC audible alarm sounds, the individual
responsible for monitoring 8M audio/video will
contact the Microbiology Supervisor.
2. Specimens will be processed using the buddy system.
3. Retrieve the following items and proceed to 8M
laboratory.
a. One sleeve of each agar media (BAP, CHOC, MAC,
SAB)
b. Two 50 mL conical tubes filled with methanol to
30 mL line
c. Anaerobic bags/generator/redox indicator
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d. PPE pack
4. Don full PPE (VII) and enter laboratory anteroom with
supplies.
5. ASSISTANT:
a. Line red trash can in anteroom with 2 red
biohazard bags.
b. Bring supplies into laboratory.
c. Place the following items in BSC:
(1) blue absorbent pad
(2) venting devices
(3) loops
(4) 50 mL conical tubes filled with methanol
in rack
(5) bleach wipes (small)
(6) gauze
(7) alcohol bottle
(8) plastic forceps
d. Cover cart with a blue absorbent pad and place
the following items on cart:
(1) media
(2) glass slides
(3) Blenderm
(4) alcohol pads
(5) metal bottle rack
(6) plastic slide carriers
e. Pour 500 mL of Chlorox Healthcare bleach into
measuring cup and then into urine container.
Place container under BSC.
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f. Position white plastic bucket near BSC and line
with a red biohazard bag.
g. Line the large red trash can with 2 red
biohazard bags.
6. PROCESSOR:
a. Place correct number of plates and slides in
BSC.
(1) 2 slides per bottle
(2) 6 plates per bottle - BAP, CHOC, MAC,
SAB, BAP ANA, CHOC ANA
b. Clean rubber septum of each bottle with an
alcohol pad. Allow to dry.
c. Insert venting device into rubber septum of
each bottle.
d. Remove venting device cap, invert bottle, and
inoculate 1 drop to each slide and 2-3 drops to
each agar plate.
(1) Using a loop, carefully spread inoculum
on slide and streak plates for isolation
and allow inoculum to dry. Discard loops
into urine container.
(2) Seal plates with Blenderm.
(3) Insert anaerobic plates into one or more
anaerobic bags. Place bag(s) and aerobic
plates into incubator.
e. Allow slides to air dry and then fix in
methanol for 30 minutes. Place 2 slides back-
to-back with uninoculated sides together. Make
sure the slides are completely submerged in the
methanol. Do not remove smears from BSC until
they have been dried and fixed.
(1) Remove slides from methanol using forceps
and place slides on gauze to dry.
(2) Close lid of methanol tube tightly and
discard in urine container.
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(3) Place dried slides in plastic slide
carrier and take to Microbiology
Laboratory for Gram stain.
(4) Apply permount and coverslip before
reading.
f. While slides are methanol fixing, cover venting
devices with gauze, remove, and discard into
urine container.
g. Remove outer gloves and discard into urine
container.
h. Put on a clean pair of extended cuff gloves.
i. Wipe outer surface of bottles with a small
bleach wipe. Discard wipe in urine container.
Wait 1 minute for bleach kill time.
j. Remove residual bleach using alcohol-soaked
gauze.
k. Place bottles in rack on cart as they are
cleaned and discard gauze into urine container.
(1) ASSISTANT:
(a) Place blood bottles in lined
plastic bucket under blood culture
instrument.
(b) Blood bottles will be discarded
after final organism
identification.
l. Decontaminate outer surface of plates, loop
bag, rack, and forceps with small bleach wipes.
(1) Wait 1 minute for bleach kill time.
m. Remove residual bleach using alcohol-soaked
gauze.
(1) Place items on cart as they are cleaned
and discard gauze into urine container.
n. Discard blue absorbent pad into urine
container.
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o. Decontaminate BSC work surface with a large
bleach wipe and discard wipe in urine
container.
(1) Wait 1 minute for bleach kill time.
o. Remove residual bleach using alcohol-soaked
gauze. Discard gauze in urine container.
p. Decontaminate outer surface of wipe container
and alcohol bottle with small bleach wipe.
(1) Discard wipe in urine container.
(2) Wait 1 minute for bleach kill time.
(3) Leave wipes and alcohol under hood.
q. Remove residual bleach using alcohol-soaked
gauze. Discard gauze in urine container.
r. Seal urine container tightly, wipe with a small
bleach wipe, and discard both in lined white
bucket.
s. Discard blue pad from cart into lined bucket.
t. Decontaminate outer pair of gloves with a large
bleach wipe.
(1) Wait 1 minute for bleach kill time.
(2) Remove outer gloves and discard along
with wipe into lined white bucket.
u. Put on a clean pair of extended cuff gloves.
v. Proceed with waste handling and doffing as in
XI.
C. BACTEC Instrument Negatives:
1. Specimens will be processed using the buddy system.
2. Don full PPE (VII) and enter laboratory anteroom.
3. Line red trash can in anteroom with 2 red biohazard
bags. Proceed into laboratory.
4. Line white plastic bucket with a red biohazard bag.
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5. Line the large red trash can with 2 red biohazard
bags.
6. Unload negative blood bottles from instrument and
place inside a urine container.
7. Seal urine container tightly and discard in lined
white bucket.
8. Proceed with waste handling and doffing as in XI.
XIII. References:
A. Interim Guidance for Specimen Collection, Transport,
Testing, and Submission for Patients with Suspected
Infection with Ebola Virus Disease. August 6, 2014.
http://www.cdc.gov/vhf/ebola/hcp/interim-guidance-specimen-
collection-submission-patients-suspected-infection-
ebola.html
B. Interim NYS/NYC Laboratory Guidelines for Handling
Specimens from Cases or Suspected Cases of Ebola Virus
Disease. August 11, 2014.
https://apps.health.ny.gov/pub/ctridocs/alrtview/postings/
Notification_17105.pdf
C. Interim Laboratory Guidelines for Handling/Testing
Specimens from Cases or Suspected Cases of Hemorrhagic
Fever Virus (HFV). August 21, 2014. American Society for
Microbiology.
D. Tightened Guidance for U.S. Healthcare Workers on Personal
Protective Equipment for Ebola. October 20, 2014.
http://www.cdc.gov/media/releases/2014/fs1020-ebola-
personal-protective-equipment.html
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Appendix 1: Dangerous Goods Form
1. Shipper Information:
a. Name of individual packaging the specimen
b. SUNY Upstate/Clinical Pathology
c. 750 East Adams Street
d. Syracuse, NY 13210
2. Consignee Information:
a. NYS Department of Health/Wadsworth Center
b. Virus Isolation Lab
c. 120 Scotland Avenue
d. Albany, NY 12208
e. (518)473-6153
3. Transport Details:
a. Cross out both "Passenger and Cargo Aircraft" and
"Cargo Aircraft only".
b. Mark NA in airport or departure.
4. Shipment Type: Cross out "Radioactive"
5. Nature and Quantity of Dangerous Goods:
a. Proper shipping name: Infectious substance, affecting
humans (possible Ebola virus)
b. Class or Division: 6.2
c. UN or ID No.: UN 2814
6. Packing Group: <leave blank>
7. Subsidiary Risk: <leave blank>
8. Quantity and Type of Packaging: 8.0 mL EDTA whole blood all
packaged in one fiberboard box.
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9. Packing intr: 620
10. Authorization: <leave blank>
11. Additional Handing Information: <leave blank>
12. Emergency Telephone Number: (315)373-3074
13. Fill out Name/Title of Signatory and Place and Date of
Shipment.
14. Sign the form with name of the preparer.
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Appendix 1 - Dangerous Goods Form - Continued
_________________
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Appendix 2 - NYSDOH Fact Sheet
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Appendix 3: Specimen Transport Cooler Cleaning Protocol
A. Specimen did not spill/leak during transport:
1. Transport cooler to Room 3818B, wearing a disposable blue
lab coat and gloves.
2. Wearing gloves, use large bleach wipes to thoroughly clean
the interior and exterior of cooler. Discard wipes in
trash can.
3. Allow cooler to sit for 5 minutes and then wipe interior
and exterior surfaces with alcohol-soaked gauze.
B. Specimen spilled/leaked during transport:
1. Proceed into 8M Laboratory.
2. Using a large bleach wipe, remove plastic transport
container from cooler and discard it, along with the wipe,
in lined white plastic bucket.
3. Remove absorbent material from cooler, being careful not to
touch soiled area, and discard in white plastic bucket.
4. Wipe gloves with a large bleach wipe. Discard wipe in
white bucket. Wait 1 minute for bleach kill time.
5. Using a large bleach wipe, thoroughly clean interior of
cooler. Discard wipe in white bucket.
6. Wipe gloves with a large bleach wipe. Discard wipe in
white bucket. Wait 1 minute for bleach kill time.
7. Using a large bleach wipe, thoroughly clean exterior of
cooler. Discard wipe in white bucket.
8. Wipe gloves with a large bleach wipe. Discard wipe in
white bucket. Wait 1 minute for bleach kill time.
9. Allow cooler to sit for 5 minutes and then wipe interior
and exterior surfaces with alcohol-soaked gauze. Discard
gauze in white bucket.
10. Pass cooler to buddy in anteroom.
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Appendix 4
VHF SPECIMEN LOG
DATE PATIENT LABEL TECH DATE/TIME
TO NYSDOH
COURIER
NAME
VHF RESULT
TRANSPORT PROCESS SHIP
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________________
Appendix 5: Donning PPE Checklist
Pre-donning procedure (private area/room 8138)
1 Remove ID badge and jewelry.
2 Tuck pant legs into socks and tuck shirt into pants.
3
Verify PAPR unit assembly
Inspect breathing tube, connections, and body
(look for gaskets, check for breaks in tube, check
threading of filters and PAPR).
Inspect filters/cartridges for correct
installation
Ensure battery is fully charged.
4
Verify PAPR air flow
Check that the correct filter is used.
Insert air flow indicator into blower opening on
top of PAPR.
Turn on blower.
Plastic cone of air flow indicator should rise
above the minimum flow mark.
If indicator does not reach minimum flow mark,
check battery and ensure that filter and cartridge
caps have been removed.
5
Inspect PAPR hood assembly
Check that breathing hose thread gasket seal is
present.
Check that thread in blower unit is in good
condition and is clear of foreign matter.
Screw end of breathing hose onto blower unit until
hand tight. Do not over-tighten.
Connect tube to headpiece, screw on end of
breathing hose until it is hand tight.
6 Check vitals of Processor, Assistant, and Buddy.
7 Inspect PPE for rips or tears.
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Appendix 5: Donning PPE Checklist - continued
Donning procedure (private area/room 8138)
1 Put on knee-length boot covers.
2 Put on first pair of nitrile gloves (blue standard
length).
3 Put on Thumbs Up Isolation gown and tie.
4
PAPR unit
Buddy holds the blower unit and helps secure
belt, ensuring the belt holders are secured in
place. Adjust belt as needed for a snug fit.
Buddy turns on the blower motor.
Place hood over the head and pull chin strap to
snug under chin.
5 Put on second pair of nitrile gloves (purple extended
cuff).
6 No exposed skin or hair should be visible.
Buddy - once Hot Zone door is closed, Buddy will:
Don appropriate PPE.
Place blue wrap on counter in warm zone.
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Appendix 6: Doffing PPE (First Out) Checklist
Pre-doffing procedure (Hot Zone)
1 Open folding chair and position near warm zone.
2 Wipe gloves with a large bleach wipe and discard wipe
in red trash can.
3 Wait 1 minute for bleach kill time.
4 Signal buddy for intention to exit the lab with the
"thumbs up" sign.
5 Sit in chair.
6 Remove boot cover from left foot without touching
gloves to pants.
7 Place left foot on floor in warm zone and discard boot
cover in red trash can.
8 Remove boot cover from right foot without touching
gloves to pants.
9 Place right foot on floor in warm zone and discard boot
cover in red trash can.
10 Stand up.
11 Wipe gloves with a large bleach wipe and discard wipe.
12 Wait 1 minute for bleach kill time.
13 Discard outer gloves.
14
Use a clean wipe to open door with left hand
Pass shipping container to buddy in anteroom.
Enter anteroom and discard wipe in anteroom trash
can.
Buddy will place shipping container on blue wrap on
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counter in anteroom and wipe gloves with a bleach wipe.
PAPR removal (Warm Zone)
1 Turn around so that PAPR is facing Buddy.
2 Buddy grasps blower unit and staff unbuckles belt.
3
Buddy disconnects air hose connected to the hood,
places unit on blue wrap on counter, and turns power
off.
4 Lean forward and remove hood into red trash can.
5 Wipe gloves with a large bleach wipe and discard wipe.
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Appendix 6: Doffing PPE (First Out) Checklist - Continued
6
Wait 1 minute for bleach kill time.
Buddy wipes down PAPR with large bleach wipe and leaves
unit on counter. Buddy wipes gloves with bleach wipe.
7 Pull gown at waist to break tie.
8 Cross arms to shoulders, pinch gown and pull outward.
9 Turn gown inside out, roll it up, and place in trash
can.
10 Wipe blue gloves with a large bleach wipe and discard
wipe.
11 Wait 1 minute for bleach kill time.
12
Remove blue pair of gloves:
Pinch glove near cuff. Roll the glove inside out
and discard in trash can.
Insert finger inside the cuff of the remaining outer
glove, pull inside out, and discard in trash can.
13 Wash hands with soap and water.
Packaging
1
Put on a clean pair of gloves and place shipping
container into box.
Remove gloves.
Wash hands with soap and water and complete
packaging process.
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Appendix 7: Doffing PPE (Last Out) and Waste Removal Checklist
Pre-doffing procedure (Hot Zone)
1
Add ~1 cup of Chlorox Healthcare bleach to red
biohazard bag in white plastic bucket to saturate
items.
2 Lift bag away from your body, taking care not to touch
the inside of the bag.
3
Grab the bag just above the level of the waste and
twist the top section. Try to minimize the amount of
incorporated air.
4 Bend the twisted top over.
5 Carefully place the zip tie around the twisted bag and
pull to close.
6 While holding the bag, wipe the outside of the bag with
a large bleach wipe. Discard wipe in red trash can.
7 Place bag into red trash can.
8 Add ~1 cup of Chlorox Healthcare bleach to red trash
can waste to saturate items.
9 Wipe gloves with a large bleach wipe and discard in red
trash can.
10 Wait 1 minute for bleach kill time.
11 Signal buddy and trained observer intention to exit the
lab with the "thumbs up" sign.
12 Sit in chair.
13 Remove boot cover from left foot without touching
gloves to pants.
14 Place left foot on floor in warm zone and discard boot
cover in red trash can.
15 Remove boot cover from right foot without touching
gloves to pants.
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16 Place right foot on floor in warm zone and discard boot
cover in red trash can.
17 Stand up.
18 Lift inner bag of red trash can away from your body,
taking care not to touch the inside of the bag.
19
Grab the bag just above the level of the waste and
twist the top section. Try to minimize the amount of
incorporated air.
20 Bend the twisted top over.
21 Carefully place the zip tie around the twisted bag and
pull to close.
22 While holding the bag, wipe the outside of the bag with
a large bleach wipe. Discard wipe in red trash can.
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Appendix 7: Doffing PPE (Last Out) and Waste Removal Checklist - Continued
23 Place bag back into red trash can.
24 Use a clean wipe to open door with left hand until door
stays in open position. Discard wipe in red trash can.
25 Lift the outer red bag of red trash can, holding it
away from your body.
26
Grab the red bag just above the level of the waste and
twist the top section. Try to minimize the amount of
incorporated air.
27 Bend the twisted top over.
28 Carefully place the zip tie around the twisted bag and
pull to close.
29 While holding the bag, wipe the outside of the bag with
a large bleach wipe.
30 Hand bag to buddy for disposal in RMW container and
discard wipe in red trash can in anteroom.
31 Wipe gloves with a large bleach wipe. Discard wipe in
red trash can in anteroom.
32 Wait 1 minute for bleach kill time.
33 Close laboratory door by pushing on laboratory side of
door. Do not touch outer (anteroom) side.
34 Keep door closed until RMW waste is removed from
anteroom.
35 Packager may leave the anteroom at this time.
36 Use a clean wipe to open door with left hand and walk
into anteroom. Discard wipe in anteroom trash can.
PAPR removal (Warm Zone)
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1 Turn around so that PAPR is facing Buddy.
2 Buddy grasps blower unit and staff unbuckles belt.
3
Buddy disconnects air hose connected to the hood,
places unit on blue wrap on counter, and turns power
off.
4 Lean forward and remove hood into red trash can.
5 Wipe gloves with a large bleach wipe and discard wipe.
6
Wait 1 minute for bleach kill time.
Buddy wipes down PAPR with large bleach wipe and leaves
unit on counter. Buddy wipes gloves with bleach wipe.
7 Pull gown at waist to break tie.
8 Cross arms to shoulders, pinch gown and pull outward.
9 Turn gown inside out, roll it up, and place in trash
can.
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Appendix 7: Doffing PPE (Last Out) and Waste Removal Checklist -
Continued
10 Wipe blue gloves with a large bleach wipe and discard
wipe.
11 Wait 1 minute for bleach kill time.
12
Remove blue pair of gloves:
Pinch glove near cuff. Roll the glove inside out
and discard in trash can.
Insert finger inside the cuff of the remaining outer
glove, pull inside out, and discard in trash can.
13 Wash hands with soap and water.
14 Put on clean glove and transport specimen cooler to
Microbiology Laboratory for cleaning (Appendix 3).
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Appendix 8: BinaxNOW Malaria Antigen Checklist
1 Place pipettor, pipette tips, one BinaxNOW card, and
BinaxNOW Reagent A in BSC.
2 Wipe outside of blood tube with a small bleach wipe.
Discard wipe in urine container.
3 Wait 1 minute for bleach kill time.
4 Mix sample by gently inverting the tube several times.
5 Remove stopper using gauze.
6 Lay stopper face up on top of gauze on blue absorbent
pad.
7 Place tube in specimen rack and clean gloves with a
small bleach wipe.
8 Discard wipe in urine container.
9 Wait 1 minute for bleach kill time.
10 Open BinaxNOW card and lay flat.
11 Pre-rinse the pipette tip and then slowly add 15 µL of
blood to the bottom half of the PURPLE sample pad.
12 Eject pipette tip into urine container.
13
There is a WHITE pad immediately below the purple
sample pad. Hold the Reagent A bottle vertically 1/2
inch above this pad and add three (3) free-falling
drops.
14
Allow the first drop to absorb into the pad before
adding the second drop. Do NOT add Reagent A directly
to the purple pad.
15 Re-cap tube with stopper.
16 Discard gauze in urine container.
17 Wipe tube with a small bleach wipe and place in rack
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until test is complete.
18 Discard wipe in urine container.
19 Allow the blood sample to run up the full length of the
test strip.
20
Do not allow the blood to run into or under the
absorbent pad at the top of the strip, as doing so will
hinder optimal washing (clearance) of the test strip.
21
Just before the blood sample reaches the base of the
white absorbent pad located at the top of the test
strip, SLOWLY add four (4) free-falling drops of
Reagent A to the wash pad on the top left-hand side of
the test device, allowing each drop to absorb into the
pad before adding the next.
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Appendix 8: BinaxNOW Malaria Antigen Checklist - Continued
22 NOTE: The third and fourth drops may not completely
absorb into the pad.
23
When the sample just reaches the base of the white
absorbent pad at the top of the test strip, remove the
adhesive liner from the right edge of the device, and
close the device.
24 Press very firmly along the entire edge to the right of
the result window.
25 Set timer for 15 minutes.
26 Read the test result through the viewing window 15
minutes after closing the test device.
27 Results read before 15 minutes may be incorrect.
28 Tilting the device may reduce glare and facilitate
interpretation.
29 Interpretation
30 The Control (C) line will appear on all valid tests.
31 Note that the appearance of any Test (T) line, even
when very faint, indicates a positive result.
32 Refer to Table for band pattern interpretation.
33 Discard blood tube in urine container.
34 Roll up Binax card in blue absorbent pad and discard in
lined white bucket.
35
Decontaminate outer surface of pipettor, pipette tip
box, rack, and Reagent A bottle with small bleach
wipes.
36 Discard wipes in urine container.
37 Wait 1 minute for bleach kill time.
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38 Remove residual bleach using alcohol-soaked gauze.
39 Place items on cart as they are cleaned and discard
gauze into urine container.
40 Decontaminate BSC work surface with a small bleach wipe
and discard wipe in urine container.
41 Remove residual bleach using alcohol-soaked gauze.
Discard gauze in urine container.
42 Decontaminate outer surface of wipe container and
alcohol bottle with small bleach wipes.
43 Discard wipes in urine container.
44 Leave wipes and alcohol under hood.
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Appendix 8: BinaxNOW Malaria Antigen Checklist - Continued
45 Seal urine container tightly, wipe with a small bleach
wipe, and discard both in lined white bucket.
46 Decontaminate outer pair of gloves with a small bleach
wipe.
47 Wait 1 minute for bleach kill time.
48 Remove outer gloves and discard along with wipe into
lined white bucket.
49 Put on a clean pair of extended cuff gloves.
50 Place items back into cart and discard blue absorbent
pad into lined white bucket.
51 Proceed with waste handling and doffing as in XI.
Upstate Hospital EVD Guidance Downtown Campus Page 169 of 250
Appendix 9: BinaxNOW Malaria Antigen Table
TEST RESULTS DESCRIPTION/INTERPRETATION
T1 (HRPII)
Positive
Positive result for P.
falciparum
T2 (aldolase)
Positive
Positive result for P. vivax
or P. malariae or P. ovale.
In some cases the appearance
of only T2 Line may indicate
a mixed infection with two
or more of these species.
T1 & T2
Positive
Positive result for P.
falciparum. In some cases
the appearance of both T1
and T2 Lines may indicate a
mixed infection of P.
falciparum with another
species.
No T1 or T2
Lines
Negative result (no malaria
antigens were detected)
Invalid and/or
Uninterpretable
Test Results
The test is invalid if the
Control (C) Line does not
appear, whether a Test (T)
Line(s) is present or not.
The test is uninterpretable
if the background color
hinders reading of the test
result at 15 minutes.
Invalid or uninterpretable
tests can occur due to
improper sample or Reagent A
addition. Consult the Test
Procedure Section and
Upstate Hospital EVD Guidance Downtown Campus Page 170 of 250
Precaution #5 before
repeating testing with a new
device. Call Technical
Service if the problem
persists.
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Appendix 10: Packaging 8M Specimens - Processor (Hot Zone):
1 Place specimen bag in BSC on blue absorbent pad.
2
Wipe surface of outer specimen bag using a small bleach
wipe.
3 Discard wipe into urine container.
4 Wait 1 minute for bleach kill time.
5 Open bags carefully and inspect contents for leakage or
contamination.
6
NOTE: If this has occurred, close the bags and do not
process. Discard entire contents into lined white
bucket. Request repeat sample collection.
7 Remove one tube from bags and place in rack for malaria
antigen.
8 Reseal bags, minimizing trapped air.
9 Wipe surface of outer bag using a small bleach wipe.
10 Place bag on metal surface of BSC.
11 Discard wipe into urine container.
12 Remove outer gloves and discard into urine container.
13 Put on clean pair of extended cuff gloves.
14 Insert specimen bag into shipping container.
15 Close the lid tightly.
16 Wipe outer surface of shipping container using a small
bleach wipe.
17 Discard wipe into urine container.
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18 Wait 1 minute for bleach kill time.
19 Give shipping container to assistant.
20 Assistant will place shipping container on table near
door.
21 Proceed with Malaria Antigen Test.
22 Assistant will read Malaria Antigen Procedure steps to
processor.
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Appendix 11: Packaging Emergency Room Specimens - Processor (Hot Zone):
1 Place specimen container in BSC on blue absorbent pad.
2
Wipe outer surface of specimen container using a small
bleach wipe.
3 Discard wipe into urine container.
4 Wait 1 minute for bleach kill time.
5 Open specimen container carefully and inspect contents
for leakage or contamination.
6
NOTE: If this has occurred, close the bags and do not
process. Discard entire contents into lined white
bucket. Request repeat sample collection.
7
Remove double biohazard bag containing the specimen.
8 Remove one tube from bags and place in rack for malaria
antigen.
9 Reseal bags, minimizing trapped air.
10 Wipe surface of outer bag using a small bleach wipe.
11 Place bag on metal surface of BSC.
12 Discard wipe into urine container.
13 Seal specimen container and discard into lined white
bucket.
14 Remove outer gloves and discard into urine container.
15 Put on clean pair of extended cuff gloves.
16 Insert specimen bag into shipping container.
17 Close the lid tightly.
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18 Wipe outer surface of shipping container using a small
bleach wipe.
19 Discard wipe into urine container.
20 Wait 1 minute for bleach kill time.
21 Give shipping container to assistant.
22 Assistant will place shipping container on table near
door.
23 Proceed with Malaria Antigen Test.
24 Assistant will read Malaria Antigen Procedure steps to
processor.
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Appendix 12: Packaging - Assistant (Cold Zone):
1 When Malaria Antigen is completed, proceed with doffing
(first out) (XI).
2 Wash hands with soap and water.
3 In anteroom, put on a clean pair of gloves.
4 Insert shipping container into box.
5 Place the foam lid over the top of the slotted foam
block.
6 Fold the top of the plastic liner into place.
7
Insert NYS Infectious Diseases Requisition into a zip
lock bag and place inside shipping container on top of
plastic liner.
8 Close the box, folding the front flap in first.
9 Remove gloves and wash hands with soap and water.
10 Complete the Shipper's Declaration of Dangerous Goods
Form per example (Appendix 1).
11 Insert Dangerous Goods Form into FedEx pouch. Reserve
one copy of form.
12 Secure lid with packing tape.
13 Attach pouch to box.
14 Take shipping box and Specimen Log (Appendix 4) to
front entrance of hospital.
15 Give box to CST courier.
16 Complete Specimen Log.
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Appendix 13: Floor Plan
Upstate Hospital EVD Guidance Downtown Campus Page 177 of 250
EVD Procedure
Procedure Issue Date: 2/16/15 Applies to: Downtown
Last Revision Date: 2/16/15
Last Review Date: 2/16/15
POC 8M Laboratory
Principle:
The following guidance is for Core Laboratory specific testing of specimens from
patients with suspected viral hemorrhagic fever (VHF). Specifically this document
provides guidance for the transport and testing of specimens by the POC Lab. This
testing includes the Piccolo xpress, Horiba ABX Micros 60, and the Hemochron
Signature Elite.
II. Background:
A. VHF is caused by members of four different viral families, including Arenaviridae,
Filoviridae, Bunyaviridae, and Flaviviridae. Person-to-person transmission occurs
through direct contact (through broken skin, mucus membranes) with infected blood or
body fluids or objects contaminated with infected fluids.
III. VHF-Specific Testing:
A. When approval for testing is given, the Core Laboratory will be notified at extension 4-
6832 or 4-6834 to schedule time that testing is needed.
B. Tests available for testing on Ebola patients or suspected patients:
1. Piccolo® xpressTM
:
a. Chemistry analyzer:
Pack 1: MG
Pack 2: ALB, ALP, ALT, AMY, AST, BILT, BUN, CA, CRE, GGT, GLUC, TP, UA
2. Horiba ABX Micros 60 Analyzer:
a. Hematology analyzer:
CBC and 3 part diff
3. Hemochron Signature Elite®:
a. Coagulation analyzer:
PT, PTT
4. Siemens Multistix 9:
a. Urine chemistries:
LEU, NIT, PRO, PH, BIO, KET, BIL, GIU
(See 103.40)
IV. Definitions:
A. Work Zone:
1. Hot Zone (laboratory):
a. defined by red tape
b. contains Ebola (or suspected) infectious waste
2. Warm Zone:
Upstate Hospital EVD Guidance Downtown Campus Page 178 of 250
a. defined by yellow tape
b. designated area between hot and cold zones for doffing
3. Cold Zone (anteroom):
a. defined by green tape
b. clean area with no infectious waste
V. Specimen Transport:
A. Personnel will be notified when specimen collection/testing is required.
1. 8M Unit:
a. Trained personnel wearing full PPE (VI.C) will bring the VHF specimen transport cooler
to the patient's room.
b. Trained personnel will transport the specimens, completed downtime requisition from the
patient's room to the 8M laboratory anteroom.
c. The transport person will open the cooler in the anteroom, remove the specimen
container, close the cooler, and proceed into the laboratory with the specimen container.
B. Specimens must be processed by trained personnel using the buddy system.
1. All processing and manipulation steps, as described below, must be performed in a
biological safety cabinet (BSC) while wearing full PPE (VI.C).
VI. Personal Protective Equipment (PPE):
A. Only properly trained individuals will be permitted to handle specimens from suspected
or confirmed VHF patients.
B. Laboratory personnel will receive initial and monthly refresher training regarding PPE
donning and doffing.
C. Packs containing necessary PPE are pre-positioned and include the following:
1. Full gown
2. Knee-length boot covers
3. Cowl
4. Outer pair of gloves (purple nitrile extended cuff)
5. Inner pair of gloves (blue nitrile)
6. Face shield
7. N95 mask
8. Scrubs
9. Crocs
10. Surgical cap
NOTE: Additional stocks of these items are available on 8M.
D. PPE donning and doffing will be observed and documented using an assistant and trained
observer.
E. Donning PPE (Private area/Room 8138):
1. Remove all personal clothing and jewelry.
2. Put on hospital scrubs and clogs and proceed to 8M.
3. Tuck pant legs into socks and tuck shirt into pants.
4. Put on surgical cap and tuck hair underneath.
5. Put on knee-length boot covers.
6. Put on N95 respirator.
7. Put on first pair of nitrile gloves (blue).
8. Put on full gown and tie tightly.
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9. Put on cowl and tuck hair underneath.
10. Put on face shield.
11. Put on second pair of nitrile gloves (purple extended cuff).
12. No exposed skin or hair should be visible.
F. Doffing PPE (first out):
1. Wave at ceiling camera to alert buddy/trainer.
2. Open folding chair and position near warm zone.
3. Wipe gloves with a large bleach wipe and discard in red trash can. Wait 2 minutes for
bleach kill time.
4. When buddy arrives, signal intention to exit lab with the "thumbs up" sign.
5. Sit in chair.
a. Remove boot cover from left foot without touching gloves to pants.
b. Place left foot on floor in warm zone and discard boot cover in red trash can.
c. Repeat process for right foot.
6. Stand up (assistant should steady chair if needed).
7. Wipe gloves with a large bleach wipe and discard. Wait 2 minutes for bleach kill time.
8. Use a clean wipe to open door with left hand until door stays in the open position.
Discard wipe in trash can.
9. Facing red trash can, remove cowl and face shield by grasping face shield straps and
cowl, lean forward over trash can, and drop into bag.
10. Wipe outer pair of gloves with a large bleach wipe. Discard wipe in trash can. Wait 2
minutes for bleach kill time.
11. Pull gown at waist to break tie.
12. Cross arms to shoulders, pinch gown and pull outward.
a. Turn inside out, roll it up, and place in trash can.
b. Do not touch gown to trash can.
NOTE: It is OK if outer gloves roll off into gown - proceed to step 13c or 14.
13. Take off outer pair of nitrile gloves.
a. Pinch glove near cuff (or near palm if glove is partially removed from previous step).
b. Roll the glove inside out and discard in trash can.
Upstate Hospital EVD Guidance Downtown Campus Page 180 of 250
c. Insert finger inside the cuff of the remaining outer glove, pull inside out, and discard in
trash can.
14. Wipe gloves with a large bleach wipe. Discard wipe. Wait 2 minutes for bleach kill
time.
15. Pass shipping container to buddy in anteroom. Buddy will place shipping container on
counter in anteroom and wipe gloves with a bleach wipe.
16. With two hands grasp the outer edges of the N95 mask (along beak). Lean forward and
pull the mask off and drop into trash can.
17. Wipe gloves with a large bleach wipe. Discard wipe. Wait 2 minutes for bleach kill time.
18. Remove surgical cap and discard in trash can.
19. Remove last pair of gloves.
a. Pinch glove near cuff.
b. Roll the glove inside out and discard in trash can.
c. Insert finger inside the cuff of the remaining outer glove, pull inside out, and discard in
trash can.
21. Step into anteroom.
21. Wash hands with soap and water.
22. Put on a clean pair of gloves and place shipping container into box.
a. Remove gloves.
b. Wash hands with soap and water and complete packaging process.
c. Remain in anteroom until laboratory door is closed.
G. Doffing PPE (last out) and Waste Removal:
1. Add ~1 cup of Chlorox Healthcare bleach to red biohazard bag in white plastic bucket to
saturate items.
2. Lift bag away from your body, taking care not to touch the inside of the bag.
3. Grab the bag just above the level of the waste and twist the top section. Try to minimize
the amount of incorporated air.
Upstate Hospital EVD Guidance Downtown Campus Page 181 of 250
4. Bend the twisted top over.
5. Carefully place the twist tie around the twisted bag and pull to close.
6. While holding the bag, wipe the outside of the bag with a large bleach wipe. Discard
wipe in red trash can.
7. Place bag into red trash can.
8. Wipe gloves with a large bleach wipe and discard in red trash can. Wait 2 minutes for
bleach kill time.
9. Signal buddy and trained observer intention to exit the lab with the "thumbs up" sign.
10. Sit in chair.
Upstate Hospital EVD Guidance Downtown Campus Page 182 of 250
a. Remove boot cover from left foot without touching gloves to pants.
b. Place left foot on floor in warm zone and discard boot cover in red trash can.
c. Repeat process for right foot.
11. Stand up.
12. Add ~1 cup of Chlorox Healthcare bleach to red trash can waste to saturate items.
13. Lift inner bag away from your body, taking care not to touch the inside of the bag.
14. Grab the bag just above the level of the waste and twist the top section. Try to minimize
the amount of incorporated air.
15. Bend the twisted top over.
16. Carefully place the twist tie around the twisted bag and pull to close.
17. While holding the bag, wipe the outside of the bag with a large bleach wipe. Discard
wipe in red trash can.
18. Place bag back into the red trash can.
19. Lift the outer red bag, holding it away from your body.
20. Grab the red bag just above the level of the waste and twist the top section. Try to
minimize the amount of incorporated air.
21. Bend the twisted top over.
22. Carefully place the twist tie around the twisted bag and pull to close.
23. While holding the bag, wipe the outside of the bag with a large bleach wipe. Discard
wipe in red trash can in anteroom.
24. Hand bag to buddy for disposal in RMW container.
25. Wipe gloves with a large bleach wipe. Discard wipe in red trash can in anteroom. Wait 2
minutes for bleach kill time.
26. Close laboratory door by pushing on laboratory side of door.
a. Do not touch outer (anteroom) side.
b. Keep door closed until RMW waste is removed from anteroom.
NOTE: Packager may leave the anteroom at this time.
27. Use a clean wipe to open door with left hand until door stays in the open position.
Discard wipe in red trash can in anteroom.
28. Facing red trash can, remove cowl and face shield by grasping face shield straps and
cowl, lean forward over trash can, and drop into bag.
29. Wipe outer pair of gloves with a large bleach wipe (from buddy). Discard wipe in trash
can. Wait 2 minutes for bleach kill time.
30. Pull gown at waist to break tie.
31. Cross arms to shoulders, pinch gown and pull outward.
a. Turn inside out, roll it up, and place in trash can.
b. Do not touch gown to trash can.
NOTE: It is OK if outer gown roll off into gown - proceed to step 32c or 33.
32. Take off outer pair of nitrile gloves:
a. Pinch glove near cuff (or near palm if glove is partially removed from previous step).
b. Roll the glove inside out and discard in trash can.
c. Insert finger inside the cuff of the remaining outer glove, pull inside out, and discard in
trash can.
33. Wipe gloves with a large bleach wipe. Discard wipe. Wait 2 minutes for bleach kill
time.
Upstate Hospital EVD Guidance Downtown Campus Page 183 of 250
34. With two hands grasp the outer edges of the N95 mask (along beak). Lean forward and
pull the mask off and drop into trash can.
35. Wipe gloves with a large bleach wipe. Discard wipe in trash can. Wait 2 minutes for
bleach kill time.
36. Remove surgical cap and discard in trash can.
37. Remove last pair of gloves.
a. Pinch glove near cuff.
b. Roll the glove inside out and discard in trash can.
c. Insert finger inside the cuff of the remaining outer glove, pull inside out, and discard in
trash can.
38. Don fresh glove and pull lab door closed while stepping into anteroom. Discard glove in
trash can in anteroom.
39. Wash hands with soap and water.
40. Put on a clean glove and transport specimen cooler to Core Laboratory for cleaning
(Form A).
H. See chart below for PPE handling of specimens.
PROCEDURE POTENTIAL
HAZARD(S)
CONTROL/PROTECTION ADDITIONAL
INFORMATION
Package receipt
and transfer of
packages to testing
area
Leaking package Place leaking package in
plastic bag and transfer to a
Biological Safety Cabinet
(BSC).
Wear approved PPE
Contact Infectious
Control Officer
immediately
Disinfect exterior of
sealed plastic bag prior
to transfer to testing
area.
Unexpected
delivery to main
lab
Place specimen in plastic
white container while
wearing appropriate PPE.
Notify Infectious
Control Officer
immediately of
expected package
delivery.
Transport of
specimens
between testing
areas
Breakage of the
specimen
container
Specimens should be
transported in a clearly
labeled, durable, leak-proof
transport container directly to
the POC Lab.
Decontaminate all
surfaces of transport
container prior to
placing in cooler.
Preparation of
specimens for
testing
Aerosolization/
Splash/Splatter Minimize the number of
workers handling the
specimens
Work inside a certified class
II BSC with the sash at the
appropriate level.
Minimize unnecessary
movements while working in
No exposed skin inside
the BSC.
Bring all necessary
material into the BSC
before starting to work.
No sharps will be used.
Dispose of all pipette
tips in dedicated
Upstate Hospital EVD Guidance Downtown Campus Page 184 of 250
the BSC. Follow acceptable
BSC practices.
Use BSL-3 practices that
include the following PPE:
fluid resistant back-closing
gown, double gloves, N95
respirator and full face shield
(eyes and mucous membranes
covered).
Limit the traffic around the
BSC.
Use only pipette tips (no
needles).
Have a dedicated rigid waste
container in the BSC.
Do not aliquot - obtain
sample directly from primary
tube.
container in the BSC.
Specimens, equipment,
and all materials must
be decontaminated
before removing from
BSC.
PROCEDURE POTENTIAL
HAZARD(S)
CONTROL/PROTECTION ADDITIONAL
INFORMATION
Bleach disinfectant Accidental
exposure Perform in BSC.
Use BSL-3 practices that
include the following PPE:
fluid resistant back-closing
gown, double gloves, N95
respirator, and full face shield
(eyes and mucous membranes
covered).
Do not vortex specimen.
Prevent contact with
skin, eyes and clothing.
Wash exposed skin
with soap and water
immediately or in the
case of a conjunctional
exposure with water.
Remove all
contaminated clothing
or shoes.
Report exposure
immediately to
Supervisor/Infection
Control.
Vortexing and
centrifuging
Aerosolizing Do not centrifuge specimen.
Do not vortex specimen.
Use whole blood for
testing.
After specimen
inactivation
completed and
before removal of
specimen from the
BSC
Accidental
transfer of
contaminated
material from the
BSC.
Wipe all tubes with
disinfectant before removing
from BSC.
Place remaining specimen in
Ziploc plastic bag. Disinfect
exterior of bag before
removing from BSC.
Disinfectants for
containers and work
surfaces.
Dedicated waste bag
for gloves and other
waste.
Upstate Hospital EVD Guidance Downtown Campus Page 185 of 250
Change gloves.
Store specimen(s) in
refrigerator inside BSL-3
suite.
Post extraction
BSC
decontamination
Contamination of
BSC surfaces. Wipe the inside of the BSC
with disinfectant.
Remove all PPE and discard
into medical waste stream.
Chlorox bleach wipe is
used: followed by
wiping down all
surfaces in the BSC and
allow to air dry.
Waste autoclaving External
contamination of
waste containers
Disinfect outside of waste
containers before removal
from BSC and BLS-3.
Chlorox bleach wipe
Dispose of PPE used in
specimen handling
waste and testing in
RMW container.
VII. Specimen Receipt and Processing:
A. Specimens must be processed by trained personnel.
1. All processing and manipulation steps, as described below, must be performed in a
biological safety cabinet (BSC) while wearing specified PPE.
a. Li-heparinized tube for Chemistry testing
b. Citrate tube for Pt, PH
c. Lavender top tube for CBC
d. Leak proof urine cap - for urinalysis
B. Turn ON BSC and ensure hood door is 3/4 down.
C. Collect all supplies needed under BSC hood.
a. Blue absorbant pad
b. Gauze
c. Pipette and pipette tips
d. Urine container - uncap
e. Piccolo xpress and/or Hemochron
f. Cartridges
g. Biohazard bag
D. Processor:
1. Place specimen container in BSC on blue absorbant pad (on one side of hood).
2. Wipe outer surface of specimen container using a small bleach wipe. Discard wipe into
urine container.
3. Open specimen container carefully and inspect contents for leakage or contamination.
NOTE: If this has occurred, close container and do not process. Discard entire contents.
Notify care provider.
4. Remove double biohazard bag containing the specimens and place on blue absorbant
pad. (Throw out plastic container.)
5. Remove samples from inner bag and discard outer bag in plastic bucket. Place in rack
for testing.
Upstate Hospital EVD Guidance Downtown Campus Page 186 of 250
7. Decontaminate outer pair of gloves with a Chlorox bleach wipe, and discard wipe into
urine container.
8. Proceed to Specimen Testing.
VIII. Specimen Testing:
A. Follow the steps below for specimen testing:
1. Perform Chemistry, Coagulation, and Urine Chemistry testing under the BSC.
2. For Chemistry and Coagulation testing remove stopper using gauze. Perform CBC
testing on analyzer without opening sample tube. (Do not remove waste when container
is 1/2 full. Contact Infectious Disease for removal.)
3. Follow manufacturer's protocol and test specific standard operating procedures for
testing.
4. When samples are obtained from tube:
a. Load disc/cartridge for testing.
b. Recap tubes and wipe tube and cap with bleach wipe.
c. Discard wipe in urine container.
d. Place samples in a clean biohazard bag.
e. Save samples in refrigerator for 3 days.
5. Place all disposables (gauze, pipette tips) in urine container. Discard cartridge/reagent
disc in the lined plastic bucket.
6. Clean outer gloves with bleach wipe, remove outer pair of extended cuff gloves, and
discard gloves and wipe into lined plastic bucket.
7. Decontaminate surface of analyzers with Chlorox wipe (wait 2 minutes). Follow
manufacturer's protocol and specific laboratory preventive maintenance procedures for
cleaning each analyzer.
8. Clean specimen rack, pipetter, and tip container with Chlorox wipes. Place on analyzer
bench.
9. Cap urine container and place in lined white bucket.
10. Roll up and discard the blue absorbent pad into the lined plastic bucket.
11. Decontaminate outer pair of gloves with a small bleach wipe, and discard wipe into
lined plastic bucket.
12. Decontaminate BSC with large bleach wipe. Discard wipe into urine container.
13. Proceed with Reporting of Results.
IX. Specimen Documentation and Reporting:
A. Report appropriate information on Form A, Specimen Log.
B. Enter results into computer.
C. Proceed with Doffing and Waste Handling as per this procedure.
X. Instrumentation Failure:
A. Techs will follow manufacturer's troubleshooting guide to repair analyzer.
B. Call Tech Support for Piccolo xpress Analyzer at (516)443-2745 (Glen Rizzardi) or 1-
800-366-8020. Abbott will replace ASAP. For ABX see sticker on front of analyzer.
C. In the event that the POC instrument fails or testing cannot be performed, the Supervisor
will be notified and another area hospital will be contacted for use of equipment.
D. CDC and NYS Department of Health will be contacted for assistance.
XI. References:
Upstate Hospital EVD Guidance Downtown Campus Page 187 of 250
A. Guidance for Specimen Collection, Transport, Testing, and Submission for Patients with
Suspected Infection with Ebola Virus Disease. August 6, 2014.
http://www.cdc.gov/vhf/ebola/hcp/interim-guidance-specimen-collection-submission-
patients-suspected-infection-ebola.html
B. NYS/NYC Laboratory Guidelines for Handling Specimens from Cases or Suspected
Cases of Ebola Virus Disease. August 11, 2014.
https://apps.health.ny.gov/pub/ctridocs/alrtview/postings/ Notification_17105.pdf
C. Laboratory Guidelines for Handling/Testing Specimens from Cases or Suspected Cases
of Hemorrhagic Fever Virus (HFV). August 21, 2014. American Society for Microbiology
D. Tightened Guidance for U.S. Healthcare Workers on Personal Protective Equipment for
Ebola. October 20, 2014. http://www.cdc.gov/media/releases/2014/fs1020-ebola-
personal-protective-equiment.html
188
Core Laboratory
__________________
Number: 107.4.1
Page: 14 of 14
FORM A
1/27/15 SL
__________________
SPECIMEN LOG
DATE PATIENT LABEL OR
PATIENT INFORMATION
TESTS
ORDERED
TESTING PERSONNEL
Upstate Hospital EVD Guidance Downtown Campus
Page 189 of 250
EVD Procedure
Procedure Issue Date: 2/16/15 Applies to: Downtown
Last Revision Date: 2/16/15
Last Review Date: 2/16/15
Hemochron Signature Elite Citrate Activated Partial Thromboplastin Lime Testing
Procedure:
I. Principle:
The Hemochron® Jr. Citrate Partial Thromboplastin Time (APTT) Test is a quantitative assay
intended for diagnostic testing. The Hemochron Jr. APTT is a measure of the intrinsic
coagulation pathway, which involves all coagulation factors except Factors VII and III (tissue
factor). The APTT is a modification of the Partial Thromboplastin Time (PTT) test that uses a
phospholipid derived from either brain or lung tissue to mimic the role of platelets in the
coagulation process and does not employ a contact activator. The APTT contains a contact
activating substance to standardize the activation of Factor XII such as glass, kaolin or
diatomaceous earth.
The Citrate APTT test is performed on the Hemochron Jr. Signature Elite instrument using a
citrated venous whole blood sample. The instrument is portable and the use of citrated
specimens allow testing to be conducted at the satellite laboratory.
The Hemochron Microcoagulation Systems utilize a mechanical endpoint clotting mechanism
in which testing occurs within the cuvette. Following whole blood sample introduction, the
instrument measures 15 microliters (µL) of blood and automatically moves the sample into the
test channel within the cuvette. The remainder of the blood sample, not needed for testing, is
automatically drawn into the waste channel of the cuvette. Sample/reagent mixing and test
initiation are performed automatically, requiring no operator interaction. After mixing with
the reagent, the sample is moved back and forth within the test channel and monitored by the
analyzer for clot formation. The clot detection mechanism consists of several LED optical
detectors aligned with the test channel of the cuvette. The speed at which the blood sample
moves between the two detectors is measured. As clot formation begins, blood flow is
impeded and the movement slows. The instrument recognizes that a clot endpoint has been
achieved when the movement decreases below a predetermined rate. Electronic optical
detection of a fibrin clot in the blood sample automatically terminates the test. Assay
resolution is achieved through the use of Platelet Factor 3 (PF3) substitute and a kaolin
activator, and does not require an incubation step. The instrument reports plasma-equivalent
(P-E) values mathematically converted from fresh whole blood. Both results (P-E and whole
Upstate Hospital EVD Guidance Downtown Campus
Page 190 of 250
blood) are displayed on-screen. The Analytic Measurement Range (AMR) for this test:
Whole Blood seconds - 90-286; Plasma-equivalent seconds - 20.0-396.9
II. Specimen:
A. 3.2% sodium citrate blue top tube
B. Sample Storage:
1. For optimal performance, testing should be done within one (1) hour of
collection.
2. The sample should be stored at room temperature (15-30°C) prior to
testing.
C. Unacceptable Sample Types:
1. Samples with any of the following characteristics should be discarded
immediately, and a fresh whole blood sample must be collected prior to
performing any test on any model Hemochron instrument.
a. Sample collected into a pre-heparinized syringe.
b. Sample contaminated with tissue thromboplastin.
c. Sample contaminated with indwelling intravenous (I.V.) solutions.
d. Sample contaminated with alcohol cleansing solution.
e. Samples with visible clotting or debris accumulation.
III. Equipment - Materials and Reagents:
A. Equipment:
1. Hemochron Signature Elite® Instrument
2. AC/DC 12 volt Power Module (for use when charging the device)
B. Materials:
1. 3.2% Citrate whole blood sample
2. Biohazard disposal receptacle
3 Sharps disposal receptacle
C. Reagents:
1. The APTT test cuvette is a self-contained disposable test chamber
preloaded with a dried preparation of kaolin, phospholipid, calcium salts,
stabilizers and buffers.
a. Each test cuvette is individually packaged in a foil pouch with a
desiccant.
(1) Each box contains 45 individually pouched cuvettes.
(2) Cuvette pouches are stamped with a lot-specific expiration
date.
PRECAUTION: All used cuvettes should be considered as
potentially infectious, handled with care and disposed of by
following standard waste facility disposal policy.
b. Preparation:
a. Hemochron Jr. cuvettes must be at room temperature
before opening the pouch.
c. Storage Requirements:
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(1) While refrigerated (2-8°C), the unopened foil-pouched test
cuvette is stable until the marked expiration date.
(2) Room temperature storage (15-30°C) is optional for sealed-
pouched cuvettes:
(a) Room temperature cuvettes are good for a
maximum of twelve weeks.
(b) Re-dating is necessary if stored at room
temperature. A re-dating label is included on the
side panel of each box of cuvettes and should be
completed.
(c) Re-dating must never exceed the marked expiration
date.
(3) Hemochron Jr. cuvettes should not be exposed to
temperatures in excess of 37°C.
2. Liquid QC Material, Level 1 and Level 2:
a. Each box of directCHECK® Whole Blood Quality Control
contains fifteen (15) dropper vials and each vial contains dried
whole blood (0.5 mL) and diluent (0.7 mL).
b. There are also four (4) reusable protective sleeves for use in
processing the control material.
c. Should be stored in refrigerator.
d. Stable until expiration date stated.
e. Complete instructions and acceptable performance ranges are
included on each package insert.
f. directCHECK Whole Blood Quality Control Manufacturer Catalog
numbers:
(1) Level 1 - DCJCPT-N
(2) Level 2 - DCJCAPPT-A
IV. Calibration:
A. There is no calibration of the instrument as calibration is completed by the
manufacturer.
V. Quality Control Procedure:
A. System Self-Checks:
1. When a test is initiated by inserting a cuvette, system checks are
automatically performed and include:
a. Verification of adequate battery power to complete a full test.
b. Verification of the test-type on the screen display to insure that the
LEDs used for identifying the tests are functioning properly.
c. Verification that the cuvette temperature is warmed to 37°C±1°C.
If this temperature is not achieved or is exceeded, an appropriate
error message will be displayed and testing is prohibited.
2. After the sample is added and the "Start" key is pressed, the system
continues a self checking process:
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a. Verification that the sample is present and is of sufficient size to
run the test.
(1) This ensures that the pumps and sample-sensing LEDs are
functioning properly and that the cuvette is adequately
sealed.
(2) If these instrument and sample parameters are not
appropriate, the test is terminated and an error message is
displayed.
b. Verification that the internal timers function correctly for each test.
(1) If the system timer and assay timer disagree, a real-time
clock error message is displayed and the test result is not
reported.
B. Electronic Quality Control (EQC):
1. EQC is used to provide a two-level electronic verification of instrument
performance.
a. This testing does not use any external device.
b. The time interval to perform EQC is recommended by the
manufacturer to occur every eight (8) hours of each patient-testing
day.
c. The internal EQC will check a Normal level (30 seconds), and an
Abnormal level of QC (300 seconds or 500 seconds) plus the
internal temperature, and will store each result.
(1) If one test fails to meet specifications, the EQC test will
stop and record all results as failed.
(2) If the user aborts the EQC, the test is not saved to the
database or printed.
(3) If a cuvette is inserted in the instrument, EQC will be
aborted and recorded as a failed test.
2. EQC can be programmed to be performed automatically at
prescribed intervals by the instrument through the Configuration
Manager or can be performed manually by the Operator.
a. Manual Performance of EQC:
(1) If the instrument is turned off, hold in the "Start" key 2-3
seconds to turn it on.
(2) When "Connecting to network" is displayed, select
"Cancel".
(3) Display the QC status menu by pressing the "QC" key
before a cuvette is inserted.
(4) Press "1-EQC". The test chamber warms to temperature
and the EQC test begins. The results are displayed while
the test is progressing.
(5) When the test is completed, the results are displayed on the
screen and written to the QC database.
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b. Automatic Performance of EQC:
(1) If enabled by designating in the Configuration Manager
programming, Electronic Quality Control (EQC) tests will
be performed automatically at present intervals if the Elite
instrument is "On" and connected to a DC source by the
AC/DC power module.
(2) If the instrument is not in use, the EQC will automatically
initiate when the instrument is activated.
NOTE: If the electronic QC procedure yields an on-screen
ERROR message, discontinue use of the instrument and
contact the manufacturer.
C. Liquid Quality Control (LQC):
1. Frequency of Liquid QC:
a. Each lot of the Hemochron Jr. cuvettes should be validated for
performance using 2 levels of LQC:
(1) When a new shipment is received.
(2) Once per 30 calendar days thereafter.
2. Procedure for Performing LQC Tests:
a. Remove the direct CHECK vials, one each Level 1 and Level 2,
from the refrigerator and allow them to come to room temperature
prior to testing.
b. Remove two test cuvettes from the refrigerator and allow them to
come to room temperature. The foil pouch must be at room
temperature before opening.
c. Visually inspect each vial to insure that the glass ampule inside the
plastic vial is intact.
d. After the reagents have reached room temperature, open the
cuvette pouch and insert into the cuvette slot on the side of the
instrument.
(1) The instrument will prompt to scan barcode on cuvette.
(2) Press the "Scan" key and hold barcode in front of barcode
reader.
e. The instrument will prompt to enter Operator ID (OID).
(1) Enter employee ID number and hold in "Enter" key for 1-2
seconds to store.
f. Press "QC" key and select QC level (1-Normal or 2-Abnormal) to
tag the sample.
(1) The instrument will prompt to scan barcode of QC located
on package insert.
(2) Press the "Scan" key and hold appropriate barcode in front
of barcode reader.
g. The instrument will signal when ready with an audible beep, and
display alternating messages: "Add sample" and "Press Start".
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(1) The instrument will remain in the ready mode for five (5)
minutes.
(2) If the testing has not been started within five (5) minutes, a
"Start timeout" will occur indicating that the current cuvette
must be discarded and a new cuvette placed in the
instrument.
h. Remove the top of the plastic seal from the directCHECK vial.
i. Insert the directCHECK vial into the white protective sleeve.
j. Holding the vial upright, tap the directCHECK vial on the table top
to settle the inner glass ampule to the bottom of the plastic vial.
k. Crush the inner glass ampule by bending the vial over the edge of
the table top.
l. Immediately repeat this crushing action one to two more times at
different locations of the vial to ensure complete breakage of the
glass ampoule.
m. Quickly invert the dropper vial (dropper tip down) end-to-end 10
times and use a downward snapping motion of the wrist to ensure
the control material flows to dropper tip.
n. Remove the vial cap.
o. Squeeze the vial to discard the first drop of control material onto a
gauze.
p. Immediately dispense as many drops of control material as needed
to fill the cuvette sample well flush to the top. Should a large
dome extend over the top of the center sample well, push it over
into the outer sample well.
q. Press the "START" key.
r. Dispose of the vial and vial cap according to institutional policy
and retain the protective sleeve for reuse.
s. Wait for a single beep signaling the conclusion of the test.
t. Results are displayed as Plasma-equivalent (P-E) seconds or
Whole Blood seconds.
u. Record result on control log.
v. The instrument will display if QC passed or failed. These ranges
are Lot number-specific so there is a slight variation from lot to lot.
w. Remove the cuvette from the instrument and dispose according to
institutional policy.
3. Out-of-Range LQC Recommendations:
a. In cases where LQC results are outside of an acceptable range, the
cause may be one of the following categories:
(1) Improper Test or Mixing Technique
(2) Expired or improperly stored QC material
(3) Expired or improperly stored test cuvettes
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(4) Instrument temperature
b. If none of the above parameters are suspect, repeat the test using
LQC material with the same lot number.
c. If this repeat does not fall within the expected range, address the
above parameters again.
d. Obtain a cuvette from a different lot number and repeat the test
using LQC of the same lot number.
e. If this repeat test still does not fall within the expected range,
contact the manufacturer.
VI. Test Procedure:
A. Follow the steps below to run the test:
1. Remove the test cuvette from the refrigerator and allow to reach room
temperature.
2. Insert the cuvette into the cuvette opening.
3. The instrument will prompt the user to scan the barcode on the cuvette
wrapper.
a. Press the "Scan" key and place barcode in front of barcode reader.
4. This initiates the pre-warm/self-check mode.
5. During the pre-warm stage, observe the display for any fault messages.
6. The instrument will prompt you to enter operator ID (OID).
a. Enter employee ID and press "Enter".
7. The instrument will prompt to enter patient ID (PID).
a. Press the "Scan" key and place patient accession number barcode
in front of barcode reader.
8. The instrument will signal when "Ready" with an audible tone.
9. The screen will display the messages "Add Sample" and "Press Start".
a. The instrument will remain in the ready mode for five (5) minutes.
b. If the testing has not been started within five (5) minutes, a "Start
timeout" will occur.
c. Discard cuvette and obtain a fresh cuvette.
10. Immediately dispense one large drop of blood into the sample well of the
test cuvette.
11. Fill the sample well from the bottom up with fresh whole blood.
12. A sufficient quantity of blood must be added directly to the center sample
well to fill it flush to the top.
13. Should a large drop of blood extend above the top of the center sample
well, creating a "dome-like" appearance, push it over into the outer ring
with the tip of the dispensing device.
14. When transferring blood into the sample well, do not force blood into the
pin located on the center of the sample well.
15. Avoid generating air bubbles in the sample well when applying the
sample.
16. Press the "START" key.
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17. Test completion will be indicated by a single beep and test results will be
displayed.
18. The instrument reports whole blood numbers mathematically converted to
an International Normalized Ratio (INR) and a plasma equivalent value.
19. Record results in log.
20. Remove the cuvette from the instrument and dispose in accordance with
institutional policy.
VII. Reporting Results:
A. Report Whole Blood (WB) results in seconds.
B. Reference Interval: 92-114 seconds
C. "Out of Range - Lo" results may indicate excessive blood coagulation activation,
possibly due to specimen contamination upon collection or processing, and should
be repeated.
1. Repeat on original specimen.
2. If results still show "Out of Range-Lo", report as "QRN (questionable
result, new specimen requested)".
3. If new sample still shows "Out of Range-Lo", use the English Text Code
"ECOAG" to report "Shortened below measuring range in repeated tests.
Shortened time is not associated with a disease state."
D. "Out of Range - Hi" results should be considered beyond clinical significance and
the test should be repeated.
1. Repeat on original specimen.
2. If results still show "Out of Range-Hi", report as "QRN (questionable
result, new specimen requested)".
3. If new sample still shows "Out of Range-Hi", use English Text Code
"EPTTC" to report "Prolonged >400 sec."
VIII. Limitations:
A. As with all diagnostic tests, results should be scrutinized in light of a specific
patient's condition and anticoagulant therapy. Any results exhibiting
inconsistency with the patient's clinical status should be repeated or supplemented
with additional test data. Samples with a hematocrit of less than 20% or greater
than 55% are not recommended due to optical densities outside of the instrument
levels of detection.
B. Tests may be affected by any of the following conditions:
1. Foaming of the sample (air bubbles)
2. Hemolysis
3. Clotted or partially clotted blood
4. Presence of the lupus anticoagulant or anti-phospholipid antibodies
(APLAs)
5. unsuspected anticoagulation with high concentrations of heparin or Low
Molecular Weight Heparins (LMWH).
IX. References:
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A. Bull, BS; Korpman, RA; Huse, WM; Briggs, BD; Heparin Therapy during
Extracorporeal Circulation: I. Problems Inherent in Existing Protocols. J Thorac
Cardiovasc Surg 1975; 69:674-684.
B. Clinical Laboratory Standards Institute (CLSI) Document GP02 - Laboratory
Documents: Development and Control; approved Guideline.
C. Clinical Laboratory Standards Institute (CLSI) Document GP17 - Clinical
Laboratory Safety; Approved Guideline.
D. Clinical Laboratory Standards Institute (CLSI) Document H03 - Procedures for
the Collection of Diagnostic Blood Specimens by Venipuncture; Approved
Standard.
E. Clinical Laboratory Standards Institute (CLSI) Document H12 - Collection,
Transport, and Preparation of Blood Specimens for Testing Plasma-Based
Coagulation Assays and Molecular Hemostasis Assays; Approved Guideline.
F. Clinical Laboratory Standards Institute (CLSI) Document H47 - One-Stage
Prothrombin Time (PT) Test and Activated Partial Thromboplastin Time (APTT)
Test; Approved Guideline.
G. Clinical Laboratory Standards Institute (CLSI) Document M29 - Protection of
Laboratory Workers from Occupationally Acquired Infections; Approved
Guideline.
H. Doty, DB; Knott, HW; Hoyt, JL; Koepke, JA: Heparin dose for accurate
anticoagulation in cardiac surgery. J Cardiovasc Surg 20:597-604, 1979.
I. Gambino, R: Monitoring heparin therapy. Lab Report for Physicians 4:17-20,
1982.
J. Hattersley, P: Activated Coagulation Time of Whole Blood. JAMA 1966:136-
436.
K. ITC Operators Manual Hemochron Signature Elite, March 2007.
L. Ogilby, JD; Kopelman, HA; Klein, LW; Agarwal, JB: Adequate heparinization
during PTCA: Assessment using Activated Clotting Times. Cath and Cardiovasc
Diag. 18:206-209, 1989.
M. Pan, CM; Jobes, D; Van Riper, D; Ogilby, JD; Lin, CY; Horrow, J; Blumenthal,
R; Mendoza, M; LaDuca, F: A Modified microsample ACT test for heparin
monitoring. J Extra-corporeal Technology, 28(1):16-20, 1996.
N. Wang, J-S; Lin-CY; Hung, W-T; Thisted, RA; Karp, RB: In vitro effects of
aprotinin on Activated Clotting Time measured with different activators. J Thorac
Cardiovasc Surg 14, 4:1135-1140, 1992.
O. Young, Donald S: Effects of Drugs on Clinical Laboratory Tests, Fourth Edition,
AACC Press, Washington, D.C., 1995.
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EVD Procedure
Procedure Issue Date: 2/16/15 Applies to: Downtown
Last Revision Date: 2/16/15
Last Review Date: 2/16/15
Hemochron Signature Elite Citrate Prothrombin Time
I. Principle:
The Hemochron® Jr. Citrate Prothrombin Time (PT) Test is a quantitative assay intended
for in vitro diagnostic use in performing a quantitative, one-stage assay for monitoring
oral anticoagulation effects by hemostasis assessment. The Prothrombin Time Test
monitors the extrinsic coagulation pathway, using a citrated whole blood sample on any
model Hemochron Whole Blood Microcoagulation System.
It is intended for use during procedures and therapeutic interventions that require
monitoring of oral anticoagulants and for hemostasis assessment before or after blood
transfusions. The Hemochron Jr. PT test is performed using fresh whole blood to ensure
accurate assessment of patient homeostasis.
The Hemochron Microcoagulation Systems utilize a mechanical endpoint clotting
mechanism in which testing occurs within the cuvette. Following whole blood sample
introduction, the instrument precisely measures 15 microliters of blood and automatically
moves it into the test channel within the cuvette. The remainder of the blood sample, not
needed for testing, is automatically drawn into the waste channel of the cuvette.
Sample/reagent mixing and test initiation are performed automatically, requiring no
operator interaction. After mixing with the reagent, the sample is moved back and forth
within the test channel and monitored by the analyzer for clot formation. The clot
detection mechanism consists of two LED optical detectors aligned with the test channel
of the cuvette. The speed at which the blood sample moves between the two detectors is
measured. The clot formation begins, blood flow is impeded and the movement slows.
The instrument recognizes that a clot endpoint has been achieved when the movement
decreases below a predetermined rate. Electronic optical detection of a fibrin clot in the
blood sample automatically terminates the test.
The instrument reports the whole blood result after a mathematical conversion to
International Normalized Ratio (INR) and plasma-equivalent (P-E) value in seconds in
order to provide a familiar clinical format and thus facilitate accurate clinical test result
interpretation. Both results (P-E and whole blood seconds) are displayed on-screen. The
International Normalized Index (ISI) for the reagent has been determined to be equal to
1.0. The Analytic Measurement Range (AMR) for INR: 0.8 to 7.0
II. Specimen:
Upstate Hospital EVD Guidance Downtown Campus
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A. 3.2% sodium citrate blue top tube
B. Sample Storage:
1. For optimal performance, testing should be done within one (1) hour of
collection.
2. The sample should be stored at room temperature (15-30°C) prior to
testing.
C. Unacceptable Sample Types:
1. Samples with any of the following characteristics should be discarded
immediately, and a fresh whole blood sample must be collected prior to
performing any test on any model Hemochron instrument.
a. Sample collected into a pre-heparinized syringe.
b. Sample contaminated with tissue thromboplastin.
c. Sample contaminated with indwelling intravenous (I.V.) solutions.
d. Sample contaminated with alcohol cleansing solution.
e. Samples with visible clotting or debris accumulation.
III. Equipment - Materials and Reagents:
A. Equipment:
1. Hemochron Signature Elite® Instrument
2. AC/DC 12 volt Power Module (for use when charging the device)
B. Materials:
1. 3.2% Citrate whole blood sample
2. Biohazard disposal receptacle
3 Sharps disposal receptacle
C. Reagents:
1. The PT test cuvette is a self-contained disposable test chamber preloaded
with a dried preparation of thromboplastin, calcium salts, stabilizers and
buffers.
a. Each test cuvette is individually packaged in a foil pouch with a
desiccant.
(1) Each box contains 45 individually pouched cuvettes.
(2) Cuvette pouches are stamped with a lot-specific expiration
date.
PRECAUTION: All used cuvettes should be considered as
potentially infectious, handled with care and disposed of by
following standard waste facility disposal policy.
b. Preparation:
a. The test cuvettes must be at room temperature (15-30°C)
before opening the pouch.
c. Storage Requirements:
(1) While refrigerated (2-8°C), the unopened foil-pouched test
cuvette is stable until the marked expiration date.
Upstate Hospital EVD Guidance Downtown Campus
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(2) Room temperature storage (15-30°C) is optional for sealed-
pouched cuvettes:
(a) Room temperature cuvettes are good for a
maximum of twelve weeks.
(b) Re-dating is necessary if stored at room
temperature. A re-dating label is included on the
side panel of each box of cuvettes and should be
completed.
(c) Re-dating must never exceed the marked expiration
date.
(3) The test cuvettes should not be exposed to temperatures in
excess of 37°C.
2. Liquid QC Material, Level 1 and Level 2:
a. Each box of directCHECK® Whole Blood Quality Control
contains fifteen (15) dropper vials and each vial contains dried
whole blood (0.5 mL) and diluent (0.7 mL).
b. There are also four (4) reusable protective sleeves for use in
processing the control material.
c. Should be stored in refrigerator.
d. Stable until expiration date stated.
e. Complete instructions and acceptable performance ranges are
included on each package insert.
f. directCHECK Whole Blood Quality Control Manufacturer Catalog
numbers:
(1) Level 1 - DCJCPT-N
(2) Level 2 - DCJCPT-A
IV. Calibration:
A. There is no calibration of the instrument as calibration is completed by the
manufacturer.
V. Quality Control Procedure:
A. System Self-Checks:
1. When a test is initiated by inserting a cuvette, system checks are
automatically performed and include:
a. Verification of adequate battery power to complete a full test.
b. Verification of the test-type on the screen display to insure that the
LEDs used for identifying the tests are functioning properly.
c. Verification that the cuvette temperature is warmed to 37°C±1°C.
If this temperature is not achieved or is exceeded, an appropriate
error message will be displayed and testing is prohibited.
2. After the sample is added and the "Start" key is pressed, the system
continues a self checking process:
Upstate Hospital EVD Guidance Downtown Campus
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a. Verification that the sample is present and is of sufficient size to
run the test.
(1) This ensures that the pumps and sample-sensing LEDs are
functioning properly and that the cuvette is adequately
sealed.
(2) If these instrument and sample parameters are not
appropriate, the test is terminated and an error message is
displayed.
b. Verification that the internal timers function correctly for each test.
(1) If the system timer and assay timer disagree, a real-time
clock error message is displayed and the test result is not
reported.
B. Electronic Quality Control (EQC):
1. EQC is used to provide a two-level electronic verification of instrument
performance.
a. This testing does not use any external device.
b. The time interval to perform EQC is recommended by the
manufacturer to occur every eight (8) hours of each patient-testing
day.
c. The internal EQC will check a Normal level (30 seconds), and an
Abnormal level of QC (300 seconds or 500 seconds) plus the
internal temperature, and will store each result.
(1) If one test fails to meet specifications, the EQC test will
stop and record all results as failed.
(2) If the user aborts the EQC, the test is not saved to the
database or printed.
(3) If a cuvette is inserted in the instrument, EQC will be
aborted and recorded as a failed test.
2. EQC can be programmed to be performed automatically at prescribed
intervals by the instrument through the Configuration Manager or can be
performed manually by the Operator.
a. Manual Performance of EQC:
(1) If the instrument is turned off, hold in the "Start" key 2-4
seconds to turn it on.
(2) When "Connecting to network" is displayed, select
"Cancel.
(3) Display the QC status menu by pressing the "QC" key
before a cuvette is inserted.
(4) Press "1-EQC". The test chamber warms to temperature
and the EQC test begins. The results are displayed while
the test is progressing.
(5) When the test is completed, the results are displayed
on the screen and written to the QC database.
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b. Automatic Performance of EQC:
(1) If enabled by designating in the Configuration Manager
programming, Electronic Quality Control (EQC) tests will
be performed automatically at present intervals if the Elite
instrument is "On" and connected to a DC source by the
AC/DC power module.
(2) If the instrument is not in use, the EQC will automatically
initiate when the instrument is activated.
NOTE: If the electronic QC procedure yields an on-screen
ERROR message, discontinue use of the instrument and
contact the manufacturer.
C. Liquid Quality Control (LQC):
1. Frequency of Liquid QC:
a. Each lot of the Hemochron cuvettes should be validated for
performance using 2 levels of LQC:
(1) When a new shipment is received.
(2) Once per 30 calendar days thereafter.
b. Complete instructions and acceptable performance ranges are
included on each package insert.
2. Procedure for Performing LQC Tests:
a. Remove the directCHECK vials, one each Level 1 and Level 2,
from the refrigerator and allow them to come to room temperature
prior to testing.
b. Remove two test cuvettes from the refrigerator and allow them to
come to room temperature. The foil pouch must be at room
temperature before opening.
c. Visually inspect each vial to insure that the glass ampule inside the
plastic vial is intact.
d. After the reagents have reached room temperature, open the
cuvette pouch and insert into the cuvette slot on the side of the
instrument.
(1) The instrument will prompt to scan barcode on cuvette.
(2) Press the "Scan" key and hold barcode in front of barcode
reader.
e. The instrument will prompt to enter Operator ID (OID).
(1) Enter employee ID number and hold in "Enter" key for 1-2
seconds to store.
f. Press "QC" key and select QC level (1-Normal or 2-Abnormal) to
tag the sample.
(1) The instrument will prompt to scan barcode of QC located
on package insert.
(2) Press the "Scan" key and hold appropriate barcode in front
of barcode reader.
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g. The instrument will signal when ready with an audible beep, and
display alternating messages: "Add sample" and "Press Start".
(1) The instrument will remain in the ready mode for five (5)
minutes.
(2) If the testing has not been started within five (5) minutes, a "Start
timeout" will occur indicating that the current cuvette must be
discarded and a new cuvette placed in the instrument.
h. Remove the top of the plastic seal from the directCHECK vial.
i. Insert the directCHECK vial into the white protective sleeve.
j. Holding the vial upright, tap the directCHECK vial on the table top
to settle the inner glass ampule to the bottom of the plastic vial.
k. Crush the inner glass ampule by bending the vial over the edge of
the table top.
l. Immediately repeat this crushing action one to two more times at
different locations of the vial to ensure complete breakage of the
glass ampoule.
m. Quickly invert the dropper vial (dropper tip down) end-to-end 10
times and use a downward snapping motion of the wrist to ensure
the control material flows to dropper tip.
n. Remove the vial cap.
o. Squeeze the vial to discard the first drop of control material onto a
gauze.
p. Immediately dispense as many drops of control material as needed
to fill the cuvette sample well flush to the top. Should a large
dome extend over the top of the center sample well, push it over
into the outer sample well.
q. Press the "START" key.
r. Dispose of the vial and vial cap according to institutional policy
and retain the protective sleeve for reuse.
s. Wait for a single beep signaling the conclusion of the test.
t. The instrument reports whole blood numbers mathematically
converted to an International Normalized Ratio (INR) and a
plasma equivalent value.
u. Record result on control log.
v. The instrument will display if QC passed or failed. These ranges
are Lot number-specific so there is a slight variation from lot to lot.
w. Remove the cuvette from the instrument and dispose according to
institutional policy.
3. Out-of-Range LQC Recommendations:
a. In cases where LQC results are outside of an acceptable range, the
cause may be one of the following categories:
(1) Improper Test or Mixing Technique
(2) Expired or improperly stored QC material
Upstate Hospital EVD Guidance Downtown Campus
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(3) Expired or improperly stored test cuvettes
(4) Instrument temperature
b. If none of the above parameters are suspect, repeat the test using
LQC material with the same lot number.
c. If this repeat does not fall within the expected range, address the
above parameters again.
d. Obtain a cuvette from a different lot number and repeat the test
using LQC of the same lot number.
e. If this repeat test still does not fall within the expected range,
contact the manufacturer.
VI. Test Procedure:
A. Follow the steps below to run the test:
1. Remove the test cuvette from the refrigerator and allow to reach room
temperature.
2. Insert the cuvette into the cuvette opening.
3. The instrument will prompt the user to scan the barcode on the cuvette
wrapper.
a. Press the "Scan" key and place barcode in front of barcode reader.
4. This initiates the pre-warm/self-check mode.
5. During the pre-warm stage, observe the display for any fault messages.
6. The instrument will prompt you to enter operator ID (OID).
a. Enter employee ID and press "Enter".
7. The instrument will prompt to enter patient ID (PID).
a. Press the "Scan" key and place patient accession number barcode
in front of barcode reader.
8. The instrument will signal when "Ready" with an audible tone.
9. The screen will display the messages "Add Sample" and "Press Start".
a. The instrument will remain in the ready mode for five (5) minutes.
b. If the testing has not been started within five (5) minutes, a "Start
timeout" will occur.
c. Discard cuvette and obtain a fresh cuvette.
10. Immediately dispense one large drop of blood into the sample well of the
test cuvette.
11. Fill the sample well from the bottom up with fresh whole blood.
12. A sufficient quantity of blood must be added directly to the center sample
well to fill it flush to the top.
13. Should a large drop of blood extend above the top of the center sample
well, creating a "dome-like" appearance, push it over into the outer ring
with the tip of the dispensing device.
14. When transferring blood into the sample well, do not force blood into the
pin located on the center of the sample well.
15. Avoid generating air bubbles in the sample well when applying the
sample.
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16. Press the "START" key.
17. Test completion will be indicated by a single beep and test results will be
displayed.
18. The instrument reports whole blood numbers mathematically converted to
an International Normalized Ratio (INR) and a plasma equivalent value.
19. Record WB results in log.
20. Remove the cuvette from the instrument and dispose in accordance with
institutional policy.
VII. Reporting Results:
A. Report Whole Blood (WB) result in seconds.
B. Reference Interval: 20-26 seconds
C. "Out of Range - Lo" results may indicate excessive blood coagulation activation
possibly due to specimen contamination upon collection or processing, and should
be repeated.
1. Repeat on original specimen.
2. If results still show "Out of Range-Lo", report as "QRN (questionable
result, new specimen requested)".
3. If new sample still shows "Out of Range-Lo", use the English Text Code
"ECOAG" to report "Shortened below measuring range in repeated tests.
Shortened time is not associated with a disease state".
D. "Out of Range - Hi" results should be repeated.
1. Repeat on original specimen.
2. If results still show "Out of Range-Hi", report as "QRN (questionable
result, new specimen requested)"
3. If new sample still shows "Out of Range-Hi", use English Text Code
"EPTC" to report "Prolonged >170 sec."
VIII. Limitations:
A. As with all diagnostic tests, results should be scrutinized in light of a specific
patient's condition and anticoagulant therapy. Any results exhibiting
inconsistency with the patient's clinical status should be repeated or supplemented
with additional test data. Samples with a hematocrit of less than 20% or greater
than 55% are not recommended due to optical densities outside of the instrument
levels of detection.
B. Tests may be affected by any of the following conditions:
1. Foaming of the sample (air bubbles)
2. Hemolysis
3. Clotted or partially clotted blood
4. Unsuspected anticoagulation
5. Presence of the lupus anticoagulant or anti-phospholipid antibodies
(APLAs)
C. Interfering Substances:
1. Many concomitant medications can also affect results.
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2. Other than the hematocrit range as outlined in "Limitations", substances
that interfere with whole blood assays but not plasma-based tests have not
been identified.
IX. References:
A. Bull, BS; Korpman, RA; Huse, WM; Briggs, BD; Heparin Therapy during
Extracorporeal Circulation: I. Problems Inherent in Existing Protocols. J Thorac
Cardiovasc Surg 1975; 69:674-684.
B. Clinical Laboratory Standards Institute (CLSI) Document GP02 - Laboratory
Documents: Development and Control; approved Guideline.
C. Clinical Laboratory Standards Institute (CLSI) Document GP17 - Clinical
Laboratory Safety; Approved Guideline.
D. Clinical Laboratory Standards Institute (CLSI) Document H03 - Procedures for
the Collection of Diagnostic Blood Specimens by Venipuncture; Approved
Standard.
E. Clinical Laboratory Standards Institute (CLSI) Document H12 - Collection,
Transport, and Preparation of Blood Specimens for Testing Plasma-Based
Coagulation Assays and Molecular Hemostasis Assays; Approved Guideline.
F. Clinical Laboratory Standards Institute (CLSI) Document H47 - One-Stage
Prothrombin Time (PT) Test and Activated Partial Thromboplastin Time (APTT)
Test; Approved Guideline.
G. Clinical Laboratory Standards Institute (CLSI) Document M29 - Protection of
Laboratory Workers from Occupationally Acquired Infections; Approved
Guideline.
H. Doty, DB; Knott, HW; Hoyt, JL; Koepke, JA: Heparin dose for accurate
anticoagulation in cardiac surgery. J Cardiovasc Surg 20:597-604, 1979.
I. Gambino, R: Monitoring heparin therapy. Lab Report for Physicians 4:17-20,
1982.
J. Hattersley, P: Activated Coagulation Time of Whole Blood. JAMA 1966:136-
436.
K. ITC Operator Manual Hemochron Signature Elite, March 2007.
L. Ogilby, JD; Kopelman, HA; Klein, LW; Agarwal, JB: Adequate heparinization
during PTCA: Assessment using Activated Clotting Times. Cath and Cardiovasc
Diag. 18:206-209, 1989.
M. Pan, CM; Jobes, D; Van Riper, D; Ogilby, JD; Lin, CY; Horrow, J; Blumenthal,
R; Mendoza, M; LaDuca, F: A Modified microsample ACT test for heparin
monitoring. J Extra-corporeal Technology, 28(1):16-20, 1996.
N. Wang, J-S; Lin-CY; Hung, W-T; Thisted, RA; Karp, RB: In vitro effects of
aprotinin on Activated Clotting Time measured with different activators. J Thorac
Cardiovasc Surg 14, 4:1135-1140, 1992.
O. Young, Donald S: Effects of Drugs on Clinical Laboratory Tests, Fourth Edition,
AACC Press, Washington, D.C., 1995.
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EVD Procedure
Procedure Issue Date: 2/16/15 Applies to: Downtown
Last Revision Date: 2/16/15
Last Review Date: 2/16/15
Hemochron Signature Elite Preventive Maintenance
Procedure: I. Principle:
A. The analyzer must be functional and operate within the limits specified by the
manufacturer. These standards are monitored by quality control procedures.
B. This procedure outlines preventative maintenance and function verification
performed on a regular basis to ensure that the analyzer meets set standards. II. Reagents and Equipment:
A. Reagents:
1. Cuvette:
a. Appropriate test cuvette for QC running.
(1) Each test cuvette is individually packaged in a foil pouch
with a desiccant.
(2) Each box contains 45 individually pouched cuvettes.
(3) Cuvette pouches are stamped with a lot-specific expiration
date.
PRECAUTION: All used cuvettes should be considered as
potentially infectious, handled with care and disposed of by
following standard waste facility disposal policy.
b. Preparation:
(1) The test cuvettes must be at room temperature (15-30°C)
before opening the pouch.
c. Storage Requirements:
(1) While refrigerated (2-8°C), the unopened foil-pouched test
cuvette is stable until the marked expiration date.
(2) Room temperature storage (15-30°C) is optional for sealed-
pouched cuvettes:
(a) Room temperature cuvettes are good for a
maximum of twelve weeks.
(b) Re-dating is necessary if stored at room
temperature. A re-dating label is included on the
side panel of each box of cuvettes and should be
completed.
(c) Re-dating must never exceed the marked expiration
date.
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(3) The test cuvettes should not be exposed to temperatures in
excess of 37°C.
2. Liquid QC Material:
a. Each box of directCheck® Whole Blood Quality Control contains
fifteen (15) dropper vials and each vial contains dried whole blood
(0.5 mL) and diluent (0.7 mL).
b. There are also four (4) reusable protective sleeves for use in
processing the control material.
c. Should be stored in refrigerator.
d. Stable until expiration date stated.
B. Supplies:
1. Kim wipes
2. bleach
3. Distilled water
C. Equipment:
1. Hemochron Signature Elite®
2. AC/DC 12 volt Power Module (for use when charging the device) III. Maintenance:
A. When In Use:
1. System Self-Checks:
a. When test is initiated by inserting a cuvette, system checks are
automatically performed and include:
(1) Verification of adequate battery power to complete a full
test.
(2) Verification of the test-type on the screen display to insure
that the LEDs used for identifying the tests are functioning
properly.
(3) Verification that the cuvette temperature is warmed to
37°C±1°C. If this temperature is not achieved or is
exceeded, an appropriate error message will be displayed
and testing is prohibited.
b. After the sample is added and the "Start" key is pressed, the
system continues a self-checking process:
(1) Verification that the sample is present and is of
sufficient size to run the test.
(a) This ensures that the pumps and sample-sensing
LEDs are functioning properly and that the cuvette
is adequately sealed.
(b) If the instrument and sample parameters are not
appropriate, the test is terminated and an error
message is displayed.
(2) Verification that the internal timers function correctly for
each test.
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(a) If the system timer and assay timer disagree, a real-
time clock error message is displayed and the test
result is not reported.
2. Electronic Quality Control (EQC):
a. EQC is used to provide a two-level electronic verification of
instrument performance.
(1) This testing does not use an external device.
(2) The time interval to perform EQC is recommended by the
manufacturer to occur every eight (8) hours of each patient-
testing day.
(3) The internal EQC will check a Normal Level (30 seconds),
and an Abnormal Level of QC (300 seconds or 500
seconds) plus the internal temperature, and will store each
result.
(a) If one test fails to meet specification, the EQC test
will stop and record all results as failed.
(b) If the user aborts the EQC, the test is not saved to
the database or printed.
(c) If a cuvette is inserted in the instrument, EQC will
be aborted and recorded as a failed test.
b. EQC can be programmed to be performed automatically at
prescribed intervals by the instrument through the Configuration
Manager or can be performed manually by the Operator.
(1) Manual Performance of EQC:
(a) If the instrument is turned off, then hold in "Start"
key 2-3 seconds to turn it on.
(b) When "Connecting to network is displayed" then
select "Cancel".
(c) Display the QC status menu by pressing the "QC"
key before a cuvette is inserted.
(d) Press "1-EQC". The test chamber warms to
temperature and the EQC test begins. The results
are displayed while the test is progressing.
(e) When the test is completed, the results are displayed
on the screen and written to the QC database.
(2) Automatic Performance of EQC:
(a) If enabled by designating in the Configuration Manager
programming, Electronic Quality Control (EQC) tests will
be performed automatically at present intervals if the Elite
instrument is "On" and connected to a DC source by the
AC/DC power module.
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(b) If the instrument is not in use, the EQC will
automatically initiate when the instrument is
activated.
NOTE: If the electronic QC procedure yields an
on-screen ERROR message, discontinue use of the
instrument and contact the manufacturer.
3. Disinfecting Instrument:
a. Disinfect outer parts of instrument after each patient as needed.
(1) Wipe outside of analyzer using bleach (Clorox wipes)
after each patient.
(2) Re-wipe outside of analyzer with water-dampened gauze to
remove any residual bleach from plastic surfaces.
(3) Inspect and clean cuvette opening as needed by removing
residual blood with a water dampened gauze or cotton swab
only.
(4) DO NOT use solvents or strong cleaning solutions as they
may damage instrument components.
4. Battery Care:
a. The life of the internal Lithium battery is optimized when the
battery is exercised by using it on a regular basis; (i.e.; run battery
life during the day and charge it at night by plugging it into an AC
outlet).
b. "Charge Battery" will display if batteries are drained to the point
that valid testing cannot be performed. Plug into AC outlet to
continue testing.
B. Monthly:
1. Liquid Quality Control (LQC):
a. Frequency of Liquid QC:
(1) Each lot of the Hemochron cuvettes should be validated for
performance using 2 levels of LQC:
(a) When a new shipment is received.
(b) Once per 30 calendar days thereafter.
(2) Complete instructions and acceptable performance ranges
are included on each package insert.
b. Procedure for Performing LQC Tests:
(1) Remove the directCheck vials, one each, Level 1 and Level
2, from the refrigerator and allow them to come to room
temperature prior to testing.
(2) Remove two test cuvettes from the refrigerator and allow
them to come to room temperature. The foil pouch must be
at room temperature before opening.
Upstate Hospital EVD Guidance Downtown Campus
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(3) Visually inspect each vial to insure that the glass ampule
inside the plastic vial is intact.
(4) After the reagents have reached room temperature, open the
cuvette pouch and insert into the cuvette slot on the side of
the instrument.
(a) The instrument will prompt to scan barcode on
cuvette.
(b) Press the "Scan" key and hold barcode in front of
the barcode reader.
(5) The instrument will prompt to enter Operator ID (OID).
(a) Enter employee ID number and hold in "Enter" key
for 1-2 seconds to store.
(6) Press "QC" key and select QC Level (1-Normal or 2-
Abnormal) to tag the sample.
(a) The instrument will prompt to scan barcode of QC
located on package insert.
(b) Press the "Scan" key and hold appropriate barcode
in front of barcode reader.
(7) The instrument will signal when ready with an audible beep
and display alternating messages: "Add Sample" and "Press
Start".
(a) The instrument will remain in the ready mode for
five (5) minutes.
(b) If the testing has not been started within five (5)
minutes, a "Start Timeout" will occur indicating that
the current cuvette must be discarded and a new
cuvette placed in the instrument.
(8) Remove the top of the plastic seal from the directCHECK
vial.
(9) Insert the directCHECK vial into the white protective
sleeve.
(10) Holding the vial upright, tap the directCHECK vial on the
table top to settle the inner glass ampule to the bottom of
the plastic vial.
(11) Crush the inner glass ampule by bending the vial over the
edge of the table top.
(12) Immediately repeat this crushing action one to two more
times at different locations of the vial to ensure complete
breakage of the glass ampule.
(13) Quickly invert the dropper vial (dropper tip down) end-to-
end 10 times and use a downward snapping motion of the
wrist to ensure the control material flows to dropper tip.
(14) Remove the vial cap.
Upstate Hospital EVD Guidance Downtown Campus
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(15) Squeeze the vial to discard the first drop of control material
onto a gauze.
(16) Immediately dispense as many drops of control material as
needed to fill the cuvette sample well flush to the top.
Should a large dome extend over the top of the center
sample well, push it over into the outer sample well.
(17) Push the "START" key.
(18) Dispose of the vial and vial cap according to institutional
policy and retain the protective sleeve for reuse.
(19) Wait for a single beep signaling the conclusion of the test.
(20) The instrument displays the result.
(21) Record result on control log.
(22) The instrument will display if QC passed or failed. These
ranges are Lot Number-specific so there is a slight variation
from lot to lot.
(23) Remove the cuvette from the instrument and dispose
according to institutional policy.
c. Out-of-Range LQC Recommendations:
(1) In cases where LQC results are outside of an acceptable
range, the cause may be one of the following categories:
(a) Improper Test or Mixing Technique
(b) Expired or Improperly Stored QC Material
(c) Expired or Improperly Stored Test Cuvettes
(d) Instrument Temperature
(2) If none of the above parameters are suspect, repeat the test
using LQC material with the same lot number.
(3) If this repeat does not fall within the expected range,
address the above parameters again.
(4) Obtain a cuvette from a different lot number and repeat the
test using LQC of the same lot number.
(5) If this repeat test still does not fall within the expected
range, contact the manufacturer.
IV. References:
A. ITC Operator's Manual, Hemochron Signature Elite, March 2007.
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EVD Procedure
Procedure Issue Date: 2/16/15 Applies to: Downtown
Last Revision Date: 2/16/15
Last Review Date: 2/16/15
Hemochrom Signature Elite Training Checklist
EMPLOYEE: ___________________________OBSERVED BY: ______________________
ASSESSMENT FOR THE TIME PERIOD: _______________ TO _____________________
□ COMPETENCY □ TRAINING
ITEM V W DO ACCEPTABLE
COMPETENCE
DATE
INITIAL
YES NO*
1 Able to name and locate all components on the Hemochron
Signature Elite: display panel, keypad, test chamber, and
barcode scanner.
2 Properly performs and documents the when in use and
monthly Preventive Maintenance procedures as detailed in
the Procedure Manual.
3 Understands the location, storage, and stability of test
cartridges and liquid control materials.
4 Demonstrates knowledge on how to perform and record
Quality Control Protocol: EQC, LQC.
5 Understands Specimen and Processing Requirements.
6 Understands Loading Requirements.
7 Understands test results and familiar with Data Entry
Procedure.
8 Acceptable performance of an unknown and/or control
analysis (attach results).
9 Practices Universal Precautions and exhibits compliance
with all safety protocols.
10 Acceptable performance on written exercise (80%).
11 Review of written procedure (employee initials). Assessment Method: V = verbal; W = written; DO = direct observation
*If unacceptable performance noted, please detail corrective action and achievement of acceptable competency.
Item #: _______________________ Date: _________________________
Corrective Action: __________________________________________________________
Employee: _______________________________________________ Date: ___________
Competency Officer: _____________________________________ Date: ___________
Upstate Hospital EVD Guidance Downtown Campus
Page 214 of 250
EVD Procedure
Procedure Issue Date: 2/16/15 Applies to: Downtown
Last Revision Date: 2/16/15
Last Review Date: 2/16/15
Hemochron Signature Elite General Operating Procedure
I. Principle:
The Hemochron Microcoagulation Systems utilize a mechanical endpoint clotting
mechanism in which testing occurs within the cuvette. Following whole blood sample
introduction, the instrument precisely measures 15 microliters of blood and automatically
moves it into the test channel within the cuvette. The remainder of the blood sample, not
needed for testing, is automatically drawn into the waste channel of the cuvette.
Sample/reagent mixing and test initiation are performed automatically, requiring no
operator interaction. After mixing with the reagent, the sample is moved back and forth
within the test channel and monitored by the analyzer for clot formation. The clot
detection mechanism consists of two LED optical detectors aligned with the test channel
of the cuvette. The speed at which the blood sample moves between the two detectors is
measured. As clot formation begins, blood flow is impeded and the movement slows.
The instrument recognizes that a clot endpoint has been achieved when the movement
decreases below a predetermined rate. Electronic optical detection of a fibrin clot in the
blood sample automatically terminates the test.
II. Specimen:
A. 3.2% sodium citrate blue top tube
B. Sample Storage:
1. For optimal performance, testing should be done within one (1) hour of
collection.
2. The sample should be stored at room temperature (15-30°C) prior to
testing.
C. Unacceptable Sample Types:
1. Samples with any of the following characteristics should be discarded
immediately, and a fresh whole blood sample must be collected.
a. Sample collected into a pre-heparinized syringe.
b. Sample contaminated with tissue thromboplastin.
c. Sample contaminated with indwelling intravenous (I.V.) solutions.
d. Sample contaminated with alcohol cleansing solution.
e. Samples with visible clotting or debris accumulation.
III. Equipment - Materials and Reagents:
A. Equipment:
1. Hemochron Signature Elite® Instrument
2. AC/DC 12 volt Power Module (for use when charging the device)
B. Materials:
Upstate Hospital EVD Guidance Downtown Campus
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1. 3.2% Citrate whole blood sample
2. Biohazard disposal receptacle
3 Sharps dsposal receptacle
C. Reagents:
1. Cuvette:
a. Appropriate test cuvette for test ordered.
(1) Each test cuvette is individually packaged in a foil pouch
with a desiccant.
(2) Each box contains 45 individually pouched cuvettes.
(3) Cuvette pouches are stamped with a lot-specific expiration
date.
PRECAUTION: All used cuvettes should be considered as
potentially infectious, handled with care and disposed of by
following standard waste facility disposal policy.
b. Preparation:
(1) The test cuvettes must be at room temperature (15-30°C)
before opening the pouch.
c. Storage Requirements:
(1) While refrigerated (2-8°C), the unopened foil-pouched test
cuvette is stable until the marked expiration date.
(2) Room temperature storage (15-30°C) is optional for sealed-
pouched cuvettes:
(a) Room temperature cuvettes are good for a
maximum of twelve weeks.
(b) Re-dating is necessary if stored at room
temperature. A re-dating label is included on the
side panel of each box of cuvettes and should be
completed.
(c) Re-dating must never exceed the marked expiration
date.
(3) The test cuvettes should not be exposed to temperatures in
excess of 37°C.
2. Liquid QC Material:
a. Each box of directCHECK® Whole Blood Quality Control
contains fifteen (15) dropper vials and each vial contains dried
whole blood (0.5 mL) and diluent (0.7 mL).
b. There are also four (4) reusable protective sleeves for use in
processing the control material.
c. Should be stored in refrigerator.
d. Stable until expiration date stated.
IV. Calibration:
A. There is no calibration of the instrument as calibration is completed by the
manufacturer.
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V. Quality Control Procedure:
A. System Self-Checks:
1. When a test is initiated by inserting a cuvette, system checks are
automatically performed and include:
a. Verification of adequate battery power to complete a full test.
b. Verification of the test-type on the screen display to insure that the
LEDs used for identifying the tests are functioning properly.
c. Verification that the cuvette temperature is warmed to 37°C±1°C.
If this temperature is not achieved or is exceeded, an appropriate
error message will be displayed and testing is prohibited.
2. After the sample is added and the "Start" key is pressed, the system
continues a self checking process:
a. Verification that the sample is present and is of sufficient size to
run the test.
(1) This ensures that the pumps and sample-sensing LEDs are
functioning properly and that the cuvette is adequately
sealed.
(2) If these instrument and sample parameters are not
appropriate, the test is terminated and an error message is
displayed.
b. Verification that the internal timers function correctly for each test.
(1) If the system timer and assay timer disagree, a real-time
clock error message is displayed and the test result is not
reported.
B. Electronic Quality Control (EQC):
1. EQC is used to provide a two-level electronic verification of instrument
performance.
a. This testing does not use any external device.
b. The time interval to perform EQC is recommended by the
manufacturer to occur every eight (8) hours of each patient-testing
day.
c. The internal EQC will check a Normal level (30 seconds), and an
Abnormal level of QC (300 seconds or 500 seconds) plus the
internal temperature, and will store each result.
(1) If one test fails to meet specifications, the EQC test will
stop and record all results as failed.
(2) If the user aborts the EQC, the test is not saved to the
database or printed.
(3) If a cuvette is inserted in the instrument, EQC will be
aborted and recorded as a failed test.
2. EQC can be programmed to be performed automatically at prescribed
intervals by the instrument through the Configuration Manager or can be
performed manually by the Operator.
Upstate Hospital EVD Guidance Downtown Campus
Page 217 of 250
a. Manual Performance of EQC:
(1) If the instrument is turned off, hold in the "Start" key 2-3
seconds to turn it on.
(2) When "Connecting to network" is displayed, select
"Cancel".
(3) Display the QC status menu by pressing the "QC" key
before a cuvette is inserted.
(4) Press "1-EQC". The test chamber warms to temperature
and the EQC test begins. The results are displayed while
the test is progressing.
(5) When the test is completed, the results are displayed on the
screen and written to the QC database.
b. Automatic Performance of EQC:
(1) If enabled by designating in the Configuration Manager
programming, Electronic Quality Control (EQC) tests will
be performed automatically at present intervals if the Elite
instrument is "On" and connected to a DC source by the
AC/DC power module.
(2) If the instrument is not in use, the EQC will automatically
initiate when the instrument is activated.
NOTE: If the electronic QC procedure yields an on-screen ERROR
message, discontinue use of the instrument and contact the manufacturer.
C. Liquid Quality Control (LQC):
1. Frequency of Liquid QC:
a. Each lot of the Hemochron cuvettes should be validated for
performance using 2 levels of LQC:
(1) When a new shipment is received.
(2) Once per 30 calendar days thereafter.
b. Complete instructions and acceptable performance ranges are
included on each package insert.
2. Procedure for Performing LQC Tests:
a. Remove the directCHECK vials, one each Level 1 and Level 2,
from the refrigerator and allow them to come to room temperature
prior to testing.
b. Remove two test cuvettes from the refrigerator and allow them to
come to room temperature. The foil pouch must be at room
temperature before opening.
c. Visually inspect each vial to insure that the glass ampule inside the
plastic vial is intact.
d. After the reagents have reached room temperature, open the
cuvette pouch and insert into the cuvette slot on the side of the
instrument.
(1) The instrument will prompt to scan barcode on cuvette.
Upstate Hospital EVD Guidance Downtown Campus
Page 218 of 250
(2) Press the "Scan" key and hold barcode in front of barcode
reader.
e. The instrument will prompt to enter Operator ID (OID).
(1) Enter employee ID number and hold in "Enter" key for 1-2
seconds to store.
f. Press "QC" key and select QC level (1-Normal or 2-Abnormal) to
tag the sample.
(1) The instrument will prompt to scan barcode of QC located
on package insert.
(2) Press the "Scan" key and hold appropriate barcode in front
of barcode reader.
g. The instrument will signal when ready with an audible beep, and
display alternating messages: "Add sample" and "Press Start".
(1) The instrument will remain in the ready mode for five (5)
minutes.
(2) If the testing has not been started within five (5) minutes, a
"Start timeout" will occur indicating that the current cuvette
must be discarded and a new cuvette placed in the
instrument.
h. Remove the top of the plastic seal from the directCHECK vial.
i. Insert the directCHECK vial into the white protective sleeve.
j. Holding the vial upright, tap the directCHECK vial on the table top
to settle the inner glass ampule to the bottom of the plastic vial.
k. Crush the inner glass ampule by bending the vial over the edge of
the table top.
l. Immediately repeat this crushing action one to two more times at
different locations of the vial to ensure complete breakage of the
glass ampule.
m. Quickly invert the dropper vial (dropper tip down) end-to-end 10
times and use a downward snapping motion of the wrist to ensure
the control material flows to dropper tip.
n. Remove the vial cap.
o. Squeeze the vial to discard the first drop of control material onto a
gauze.
p. Immediately dispense as many drops of control material as needed
to fill the cuvette sample well flush to the top. Should a large
dome extend over the top of the center sample well, push it over
into the outer sample well.
q. Press the "START" key.
r. Dispose of the vial and vial cap according to institutional policy
and retain the protective sleeve for reuse.
s. Wait for a single beep signaling the conclusion of the test.
t. The instrument displays the result.
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u. Record result on control log.
v. The instrument will display if QC passed or failed. These ranges
are Lot number-specific so there is a slight variation from lot to lot.
w. Remove the cuvette from the instrument and dispose according to
institutional policy.
3. Out-of-Range LQC Recommendations:
a. In cases where LQC results are outside of an acceptable range, the
cause may be one of the following categories:
(1) Improper Test or Mixing Technique
(2) Expired or improperly stored QC material
(3) Expired or improperly stored test cuvettes
(4) Instrument temperature
b. If none of the above parameters are suspect, repeat the test using
LQC material with the same lot number.
c. If this repeat does not fall within the expected range, address the
above parameters again.
d. Obtain a cuvette from a different lot number and repeat the test
using LQC of the same lot number.
e. If this repeat test still does not fall within the expected range,
contact the manufacturer.
VI. Test Procedure:
A. Follow the steps below to run the test:
1. Remove the test cuvette from the refrigerator and allow to reach room
temperature.
2. Insert the cuvette into the cuvette opening.
3. The instrument will prompt the user to scan the barcode on the cuvette
wrapper.
a. Press the "Scan" key and place barcode in front of barcode reader.
4. This initiates the pre-warm/self-check mode.
5. During the pre-warm stage, observe the display for any fault messages.
6. The instrument will prompt you to enter operator ID (OID).
a. Enter employee ID and press "Enter".
7. The instrument will prompt to enter patient ID (PID).
a. Press the "Scan" key and place patient accession number barcode
in front of barcode reader.
8. The instrument will signal when "Ready" with an audible tone.
9. The screen will display the messages "Add Sample" and "Press Start".
a. The instrument will remain in the ready mode for five (5) minutes.
b. If the testing has not been started within five (5) minutes, a
"Start timeout" will occur.
c. Discard cuvette and obtain a fresh cuvette.
10. Immediately dispense one large drop of citrated blood into the
sample well of the test cuvette.
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11. Fill the sample well from the bottom up with fresh whole blood.
12. A sufficient quantity of blood must be added directly to the center sample
well to fill it flush to the top.
13. Should a large drop of blood extend above the top of the center sample
well, creating a "dome-like" appearance, push it over into the outer ring
with the tip of the dispensing device.
14. When transferring blood into the sample well, do not force blood into the
pin located on the center of the sample well.
15. Avoid generating air bubbles in the sample well when applying the
sample.
16. Press the "START" key.
17. Test completion will be indicated by a single beep and test results will be
displayed.
18. Record results in log.
19. Remove the cuvette from the instrument and dispose in accordance with
institutional policy.
VII. Reporting Results:
A. Refer to Individual Assay Procedures:
1. Hemochron Signature Elite® Citrate Prothrombin Time with INR.
2. Hemochron Signature Elite® Citrate Activated Partial Thromboplastin
Time Testing.
VIII. Limitations:
A. As with all diagnostic tests, results should be scrutinized in light of a specific
patient's condition and anticoagulant therapy. Any results exhibiting
inconsistency with the patient's clinical status should be repeated or supplemented
with additional test data. Samples with a hematocrit of less than 20% or greater
than 55% are not recommended due to optical densities outside of the instrument
levels of detection.
B. Tests may be affected by any of the following conditions:
1. Foaming of the sample (air bubbles)
2. Hemolysis
3. Clotted or partially clotted blood
4. Unsuspected anticoagulation
5. Presence of the lupus anticoagulant or anti-phospholipid antibodies
(APLAs)
C. Interfering Substances:
1. Many concomitant medications can also affect results.
2. Other than the hematocrit range as outlined in "Limitations", substances
that interfere with whole blood assays but not plasma-based tests have not
been identified
References:
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A. Bull, BS; Korpman, RA; Huse, WM; Briggs, BD; Heparin Therapy during
Extracorporeal Circulation: I. Problems Inherent in Existing Protocols. J Thorac
Cardiovasc Surg 1975; 69:674-684.
B. Clinical Laboratory Standards Institute (CLSI) Document GP02 - Laboratory
Documents: Development and Control; approved Guideline.
C. Clinical Laboratory Standards Institute (CLSI) Document GP17 - Clinical
Laboratory Safety; Approved Guideline.
D. Clinical Laboratory Standards Institute (CLSI) Document H03 - Procedures for
the Collection of Diagnostic Blood Specimens by Venipuncture; Approved
Standard.
E. Clinical Laboratory Standards Institute (CLSI) Document H12 - Collection,
Transport, and Preparation of Blood Specimens for Testing Plasma-Based
Coagulation Assays and Molecular Hemostasis Assays; Approved Guideline.
F. Clinical Laboratory Standards Institute (CLSI) Document H47 - One-Stage
Prothrombin Time (PT) Test and Activated Partial Thromboplastin Time (APTT)
Test; Approved Guideline.
G. Clinical Laboratory Standards Institute (CLSI) Document M29 - Protection of
Laboratory Workers from Occupationally Acquired Infections; Approved
Guideline.
H. Doty, DB; Knott, HW; Hoyt, JL; Koepke, JA: Heparin dose for accurate
anticoagulation in cardiac surgery. J Cardiovasc Surg 20:597-604, 1979.
I. Gambino, R: Monitoring heparin therapy. Lab Report for Physicians 4:17-20,
1982.
J. Hattersley, P: Activated Coagulation Time of Whole Blood. JAMA 1966:136-
436.
K. ITC Operators Manual Hemochron Signature Elite, March 2007.
L. Ogilby, JD; Kopelman, HA; Klein, LW; Agarwal, JB: Adequate heparinization
during PTCA: Assessment using Activated Clotting Times. Cath and Cardiovasc
Diag. 18:206-209, 1989.
M. Pan, CM; Jobes, D; Van Riper, D; Ogilby, JD; Lin, CY; Horrow, J; Blumenthal,
R; Mendoza, M; LaDuca, F: A Modified microsample ACT test for heparin
monitoring. J Extra-corporeal Technology, 28(1):16-20, 1996.
N. Wang, J-S; Lin-CY; Hung, W-T; Thisted, RA; Karp, RB: In vitro effects of
aprotinin on Activated Clotting Time measured with different activators. J Thorac
Cardiovasc Surg 14, 4:1135-1140, 1992.
O. Young, Donald S: Effects of Drugs on Clinical Laboratory Tests, Fourth Edition,
AACC Press, Washington, D.C., 1995.
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EVD Procedure
Procedure Issue Date: 2/16/15 Applies to: Downtown
Last Revision Date: 2/16/15
Last Review Date: 2/16/15
Horiba ABX Micros 60 Analyzer General Operating Procedure
Equipment:
I. Principle: The Horiba ABX Micros 60 Hematology Analyzer is a quantitative,
automated hematology analyzer and leukocyte differential counter for in vitro diagnostic
use in clinical laboratories.
A. CBC Analysis:
1. An Electronic Impedance Method counts the size cells by detecting and
measuring changes in electrical resistance when a particle (such as a cell)
in a conductive liquid goes through a small aperture.
2. Blood cells suspended in a conductive liquid (diluent) act as electrical
insulators.
3. The cell suspension is pulled through the aperture by a gentle vacuum.
4. A flow of electrical current is established between two submerged
electrodes, one within the aperture housing (internal electrode) and one
suspended in the cell dilution in the aperture bath (external electrode).
5. As each cell passes through the aperture, it momentarily increases the
resistance of the electrical path between the two submerged electrodes.
6. This causes an electrical pulse that can be counted and sized.
7. While the number of pulses indicates particle count, the size of the
electrical pulse is proportional to the cell volume.
8. The WBC and RBC are directly measured parameters, the MCV is derived
from the RBC histogram, and the platelet count is derived from the
platelet histogram.
9. The MCH, MCHC, HCT and RDW are computed parameters.
B. Differential Analysis:
1. WBC differential analysis is done after a lysing action is complete.
2. The instrument analyses the height of each electronic pulse as the WBC's
pass through the Micro-aperture.
3. The pulses are then channeled, thresholded, and grouped according to their
size and calculated mathematically to create the WBC distribution curve
which in turn is known as the WBC Histogram.
C. Hemoglobinometry:
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1. The lytic reagent used for the complete blood count (CBC) parameters
prepares the blood so the system can count leukocytes and measure the
amount of hemoglobin.
2. The lytic reagent rapidly and simultaneously destroys the erythrocytes and
converts a substantial proportion of the hemoglobin to a stable pigment
while it leaves leukocyte nuclei intact.
3. The absorbance of the pigment is directly proportional to the hemoglobin
concentration of the sample.
D. Hematocrit:
1. The Hematocrit is a combination measurement of electronic pulses and
mathematical calculations.
2. All the RBC pulses are grouped into various sizes.
3. Each group pulse height is then averaged.
4. All the pulse height averages are then averaged one final time for a Mean
average of all the RBC pulse heights.
5. This is a function of the numeric integration of the MCV.
6. Results are given as a percentage of this integration.
II. Specimen Requirements:
A. Whole blood collected in an EDTA anticoagulated (lavender cap) Vacutainer
tube. Horiba ABX recommends the use of dipotassium (K2) or tripotassium (K3)
salt of EDTA.
1. 1.0 mL of blood is required for the sample to be processed in the
automatic mode.
a. 10 µL of blood is aspirated in the automatic mode.
B. The specimen must be mixed immediately prior to processing on the analyzer.
C. Specimen Stability:
1. For CBC and Differential:
a. Run within 8 hours after collection if stored at 21.2 - 25.6°C (70-
78°F).
D. Specimens that are mislabeled, unlabeled, clotted, collected in the wrong tube,
grossly hemolyzed, contaminated with IV fluids, or the quantity of the sample is
not sufficient for the ordered test, must be rejected. These samples are to be
credited and the appropriate individual notified that the test cannot be performed.
III. Reagents - Special Supplies and Equipment:
A. Reagents:
1. ABX Minipack LMG (REF #0602050):
a. Reagent 1 (5L):
(1) Enzymatic solution with proteolytic action for the cleaning
of Horiba ABX blood cell counters.
b. Reagent 2 (3L):
(1) Erythrocyte lysing agent for white blood cell counting, and
differentiation and hemoglobin determination on Horiba
ABX blood cell counters.
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c. Reagent 3 (4L):
(1) Buffer isotonic solution for the determination and the
differentiation of blood cells, and the measurement of the
hematocrit on Horiba ABX blood cell counters.
2. Replacing Reagents:
a. Reagents are stored at ambient room temperature and discarded at
the expiration date.
b. Reagent pack includes the entire set of reagents in the "Pack" and
is able to receive the waste liquids.
(1) The three soft pockets contain the 3 reagents and are closed
by means of the valve connectors located at the bottom of
the pack.
(2) The fourth pocket is empty and is intended for receiving
waste liquids.
c. To change the reagent pack, remove the reagent output protections,
as well as the waste input protection.
(1) Install the pack directly into the compartment of the
instrument.
(2) Push the pack down in order to plug correctly the pack on
the male connectors.
(3) The free male connector must be plugged on the pack upper
valve in order to receive the waste liquids.
B. Supplies:
1. ABX Minoclair
2. ABX Minipack LMG
3. Minotrol 16 controls - 3 levels
4. Distilled H2O
5. Clorox bleach (for troubleshooting)
6. Gauze or tissue
7. Printer paper
C. Equipment:
1. Horiba ABX Micros 60 Analyzer
2. Power supply
3. Printer
IV. Calibration - ABX Minocal:
A. Calibration of the Micros and Minocal is performed:
1. Upon installation
2. On a semi-annual basis
3. Following the replacement of a major component or a repair effecting
calibration
4. As a result of a drift or problem with the quality control
5. Per ABX service.
B. The Micros Calibration Procedure:
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1. Auto Calibration:
a. From the Calibration Menu Select "1" "Autocalibration".
b. Select one of the (4) Operators (O.P.) which may be entered in the
"System Set-up" menu.
c. Press the "Enter" key.
d. The LCD will display a message saying "Error: No Smart Card".
e. Press the "ESC" key which will allow entry into the "Calibration"
menu to edit all the calibration information manually.
f. Press the "Enter" key to enter the new lot number of the calibrator
material.
g. Enter the new "Lot Number" of the current calibrator from the
Assay sheet that comes with the calibration material.
(1) Use the "Up" and "Down" arrow keys to enter the numbers.
(2) Press the "Enter" key to save the new lot number and move
to the next entry.
h. The next screen will indicate changing the expiration date of the
new calibrator.
(1) Press the "Enter" key and enter the new expiration date
from the Calibration Assay sheet.
(2) Use the "Period" key after the day.
(3) Press the "Enter" key to save the new expiration date.
(4) Move to the next entry.
i. The next screen will indicate changing the WBC Target Value.
(1) Press the "Enter" key and enter the new target value for the
WBC from the Calibration Assay sheet.
(2) Press the "Enter" key to save the new target value.
(3) Move to the next entry.
j. Repeat steps I (1) through (3) for the RBC, HGB, HCT, PLT, and
MPV.
k. The next screen will appear and ask if there is a change to the
number of samples to be run for the calibration a-i. Then press
"Enter".
l. The LCD will now state "RUN CAL?".
m. Press the "Enter" key to start the calibration process.
n. Once a prime cycle is done a message of "Start Calibration"
appears.
(1) Select the tube holder position for the calibrator vial and
rotate it to the 12 0'clock position.
(2) Now gently and thoroughly mix the Calibrator material as
indicated on the instruction sheet that comes with the
calibrator.
o. Place the calibrator into the tube holder and press the "Start"
key on the front panel to initiate the cycle of first sample.
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(1) The LCD display will indicate "Close the tube holder
door".
(2) When the cycle is done, the door will open so that the vial
can be removed for the next cycle.
p. Mix the material for the next calibration run.
(1) When the first sample is complete the results will display
on the screen.
(2) Press "Enter" to continue.
q. The next LCD will ask to "Accept" or "Reject" the results.
(1) Press "ESC" key to reject and start all over.
(2) Press "Enter" to accept the result and validate the results.
r. The display will then ask for the next calibration sample
until the calibration is complete.
s. Once the calibration is complete and has passed, press the
"ESC" key until the "Main" menu is displayed.
t. Run the QC for the instrument.
2. RDW Calibration:
a. The RDW calibration is a separate calibration outside the
"Autocalibration" menu.
b. The RDW will be calibrated using ABX Minotrol.
c. Run the Normal Level control 6 times, as a regular patient.
d. When the cycles are completed calculate the mean value of RDW.
e. Calculate the new calibration factor using the mean in the control
package insert.
f. Enter the new value.
g. Run QC.
V. Quality Control:
A. Quality Control for the ABX Micros 60 includes:
1. Commercial controls
2. Calibration
3. Linearity verification
B. Refer to the procedure for Quality Control Monitoring and Proficiency
Testing of Clinical Tests, 101.2.
C. Running Quality Control:
1. For Minotrol (Follow the control package insert for mixing and handling
instructions.)
2. Place the Quality Control Smart Card in the reader.
3. From the "Main" menu select "2" "QC" then "1" "Automatic" if reader is
present.
4. Confirm the OP, Lot Number, Expiration Date, and Level of Control.
5. Mix the Control level selected, place it into the tube holder and close the
tube holder door.
6. The Quality Control cycle will automatically begin.
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7. The results are compared to the ranges on the Smart Card.
a. If the results are acceptable, press the "Enter" key twice to accept
the level result.
b. If the results are not acceptable, rerun that level.
8. Continue to the next level of Minotrol until all 3 levels have been run.
9. When all 3 levels of controls have been run, the display will indicate
"Valid QC?".
a. Press the "Enter" key to store the accepted QC data onto the card.
10. If any level of control fails twice, when repeated, perform a
Concentrated Cleaning and re-run the control.
11. If controls fail again after the concentrated cleaning, call Service.
VI. Instrument to Instrument Comparisons:
A. At six month intervals, 10 specimens are run on each individual instrument that
reports a CBC and Differential.
B. The average percent and absolute difference between the instruments are
calculated for all measured parameters.
C. Acceptable limits for the comparisons are:
1. WBC = ± 0.4 or 5%
2. RBC = ± 0.2 or 2%
3. Hgb = ± 0.3 or 2%
4. PLT = ± 20 or 7%
D. Unacceptable values may indicate an instrument problem or the need for
recalibration of one of the modes.
VII. Linearity Verification:
A. Linearity limits of the Horiba ABX are performed once every 6 months.
1. Use the linearity standards for each assay.
2. The materials used for validation must be matrix appropriate material with
accurate target values that are specific for the method.
3. Follow the guidelines/instructions in the package insert for the material
used.
4. Compare the results obtained with the specific target values for the
parameters.
a. All levels are expected to be in the acceptable range given for the
standard.
b. The percent bias should not exceed the CLIA limits for that
parameter.
5. The test specimen must have analyte values which at a minimum are near
the low, midpoint, and high values of the analytic measurement range
(AMR). A minimum of five points should be used to cover the AMR.
6. Compare the results using linear regression analysis.
7. Refer to the Linearity Validation section of the Quality Assurance
Procedure, 104.1.
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8. Successful verification certifies that the calibration is still valid.
Unsuccessful verification requires remedial action. Verify calibration.
9. Technical limits: Posted on analyzer.
VIII. Procedure - Patient Samples:
A. Processing Patient Samples:
1. Automatic Mode:
a. Press the "ID" key and enter either the "Sample Identification"
using the "Number" keys or the "UP" and "DOWN" arrow keys for
alphabetical characters or "Run Number" using the number keys
only.
b. Press the "Enter" key to accept the entry.
c. Mix the sample gently and thoroughly before placing it into the
tube holder.
d. Place the sample into the tube holder and close the tube holder
door. The analysis cycle will start automatically.
e. The LED on the front panel will turn "Green" when the cycle is
complete.
f. Results will automatically print out.
g. If the sample has flags, repeat the sample.
h. If the sample still has flags, perform a Concentrated Cleaning and
Re-run the sample.
i. If the sample still has flags contact Horiba ABX Technical
Support.
IX. Result Reporting:
A. Reference Intervals:
CBC MALE FEMALE
AGE RANGE AGE RANGE
WBC x 109/L 21 4-10 21 4-10
6 4.5-13 6 4.5-13
4 5-15 4 5-15
6M 6-17 6M 6-17
0 5-10 0 5-20
RBC x 1012
/L 12 4.6-6.1 12 4.1-5.3
2 4.0-5.1 2 4.0-5.2
6M 3.7-5.3 6M 3.7-5.3
3M 3.1-4.5 3M 3.1-4.5
2M 2.7-4.9 2M 2.7-4.9
1M 3.0-5.4 1M 3.0-5.4
0 3.8-6.3 0 3.8-6.3
HGB g/dL 18 13.5-18 6 11.5-15.5
12 13-17 2 11.5-13.5
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6 11.5-15.5 6M 10.5-13.5
2 11.5-13.5 3M 9.5-13.5
6M 10.5-13.5 2M 9-14
3M 9.5-13.5 1M 10-18
2M 9-14 14D 12.5-20.5
1M 10-18 0 13.5-21.5
14D 12.5-20.5
7D 13.5-21.5
0 13.5-21.5
HCT % 18 41-53 12 36-45
12 37-49 6 35-45
6 35-45 2 34-40
2 34-40 6M 33-39
6M 33-39 2M 28-42
2M 28-42 1M 31-55
1M 31-55 14D 39-63
14D 39-63 0 42-66
0 42-66
MCV fl 18 80-96 18 80-96
6 77-96 6 77-96
2 75-87 2 75-87
6M 70-86 6M 70-86
3M 74-108 3M 74-108
2M 77-115 2M 77-115
1M 85-123 1M 85-123
14D 86-123 14D 86-123
0 88-126 0 88-126
MCH pg 18 27-33 18 27-33
12 25-32 12 25-32
6 25-31 6 25-31
2 24-30 2 24-30
6M 23-30 6M 23-30
3M 25-32 3M 25-32
2M 26-32 2M 26-32
0 28-40 0 28-40
MCHC % 2 32-36 2 32-36
6M 31-36 6M 31-36
1M 30-36 1M 30-36
0 29-36 0 29-36
PLAT x 109/L 0 150-400 0 150-400
RDW 0 11.5-14.5 0 11.5-14.5
Retic % (automated) 0.6-2.8 0.6-2.8
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Absolute Retic Automated
(K/µL
0 26-122 0 26-122
WBC Differential MALE FEMALE
AGE RANGE AGE RANGE
Neutrophil (BAND) 0 0-7 0 0-0.6
Neutrophil (NEUT) 21 33-73 10 1.8-7.0
10 28-68 6 1.5-8.0
4 21-63 2 1.5-8.5
1 16-48 6M 1.0-8.5
14D 21-63 1M 1.0-9.0
0 26-48 14D 1.0-9.5
0 1.5-10.0
Eosinophil (EOS) 0 0-5 0 0-0.45
Basophil (BASO) 0 0-2 0 0-0.2
Lymphocyte (LYMP) 16 13-52 16 1.2-4.0
10 17-56 10 1.5-6.5
6 21-60 6 1.5-7.0
4 30-70 4 2.0-8.0
6M 42-80 2 3.0-9.5
1M 37-75 1 4.0-10.5
14D 28-68 6M 4.0-13.5
0 20-62 1M 2.5-16.5
0 2.0-17.0
Monocyte (MONO) 6M 0-10 21 0-0.9
1M 0-14 6 0-0.8
0 0-18 2 0-1.0
6M 0-1.2
1M 0-1.4
14D 0-2.0
0 0-2.2
XI. References:
A. ABX Micros 60 CS/CT - User Manual, Horiba ABX, Montpellier, France,
9/2005.
B. Nathan and Oski's Hematology of Infancy and Childhood, 6th Edition. Normal
Hematologic Values in Children, p. 1841, 2003.
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EVD Procedure
Procedure Issue Date: 2/16/15 Applies to: Downtown
Last Revision Date: 2/16/15
Last Review Date: 2/16/15
Horiba ABX Micros 60 Analyzer Preventive Maintenance
I. Principle:
A. The instrument must be functional and operate within the limits specified by the
manufacturer.
B. Maintenance procedures are aimed at keeping the analytical systems operating
optimally. Periodic preventive maintenance will ensure proper instrument
function and accurate patient results.
II. Reagents - Special Supplies and Equipment:
A. Reagents:
1. ABX Minipack LMG (Ref. #0602050)
B. Supplies:
1. ABX Minoclair
2. ABX Minipack LMG
3. Minotrol 16 controls - 3 levels
4. Distilled H2O
5. bleach
6. Gauze or tissue
7. Printer paper
C. Equipment:
1. Horiba ABX Micros 60 Analyzer
III. Preventive Maintenance - Day of Use:
A. Startup and Standby Cycles:
1. At the beginning of each day of use perform a Startup Cycle.
2. Press the "Startup" key on the front of the instrument panel.
3. At the end of the day, perform a Standby Cycle.
4. Press the "Standby" key on the front of the instrument. This cycle takes
about one minute.
B. Quality Control (with QC Smart Card):
1. For Minotrol, refer to the Control Package insert for mixing and handling
instructions.
2. Place the "Quality Control Smart Card" in the reader.
3. From the Main Menu, select <2> QC, then <1> AUTOMATIC, if reader
is present.
4. Confirm the OP, Lot Number, Expiration Date, and Level of Control
5. Mix the control level selected, REMOVE CAP, place it into the tube
holder and close the tube holder door.
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6. The Quality Control Cycle will automatically begin.
7. The results are compared to the ranges on the Smart Card.
a. If the results are acceptable (NO flags), press the "Enter" key twice
to accept the level result.
b. If the results are unacceptable with flags (*,$,!,H,L), repeat the
analysis of that level.
8. Continue with the next level of MINOTROL until all 3 levels have been
run.
9. When all 3 levels of controls have been run, the display will indicate
"Valid QC?".
a. Press the "Enter" key to store the accepted QC data onto the card.
10. If any level of control fails twice, when repeated, perform a Concentrated
Cleaning and re-run the control.
11. If controls fail again after the concentrated cleaning, call the Horiba ABX
Technical Support Representative.
C. General Cleaning of the Instrument:
1. Clean the outside surface of the instrument each day of use for dried blood
deposits with 10% bleach solution.
IV. Preventive Maintenance - Weekly (when in use):
A. Concentrated Cleaning (This service function allows the operator to perform a
very strong cleaning of the WBC and RBC counting chambers and apertures.
1. From the Service Menu, use the "Down" arrow and select "4 -
Concentrated Cleaning".
2. Press the "Enter" key to access this function and follow the steps that
appear on the display indicated: "Close the tube holder door, press a key to
continue...."
3. Open the main cover door of the ABX Micros 60 as indicated: "Please
open cover door, press a key to continue..."
4. Dispense the ABX Minoclair into the RBC chamber and into the hole on
the top of the WBC chamber cover so that it goes into the chamber.
5. The display states: "Pour 3 mL of cleaner in the WBC chamber, press a
key to continue." Use a disposable pipette to perform this step
6. Then the display states: "Pour 3 mL of cleaner in the RBC chamber, press
a key to continue." Use a disposable pipette to perform this step.
7. After the solution has been added to both chambers, press any key to
continue. The cleaning cycle will begin and a cleaning time will be
displayed.
8. After this procedure is complete, perform a "Startup" cycle to verify that
the background parameters are within their limits.
9. Once the Startup Cycle has passed, QC should be performed.
V. Calibration - Every 6 months:
A. Calibration Procedure:
1. Auto Calibration:
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a. From the Calibration Menu, select "1 - Autocalibration".
b. Select one of the (4) Operators (O.P.) which may be entered in the
"System Set-up" menu.
c. Press the "Enter" key.
d. The LCD will display a message saying "Error: No Smart Card".
e. Press the "ESC" key which will allow entry into the "Calibration"
menu to edit all the calibration information manually.
f. Press the "Enter" key to enter the new lot number of the calibrator
material.
g. Enter the new "Lot Number" of the current calibrator from the
Assay Sheet that comes with the calibrator material.
(1) Use the "Up" and "Down" arrow keys to enter the numbers.
(2) Press the "Enter" key to save the new lot number and move
to the next entry.
h. The next screen will indicate changing the expiration date of the
new calibrator.
(1) Press the "Enter" key and enter the new expiration date
from the Calibration Assay Sheet.
(2) Use the "Period" key after the day.
(3) Press the "Enter" key to save the new expiration date.
(4) Move to the next entry.
i. The next screen will indicate changing the WBC Target Value.
(1) Press the "Enter" key and enter the new target value for the
WBC from the Calibration Assay Sheet.
(2) Press the "Enter" key to save the new target value.
(3) Move to the next entry.
j. Repeat steps 9a through c for the RBC, HGB, HCT, PLT, and
MPV.
k. The next screen will appear and ask if there is change to the
number of samples to be run for calibration 1-9. Then press
"Enter".
l. The LCD will now state "RUN CAL?".
m. Press the "Enter" key to start the calibration process.
n. Once a prime cycle is done a message of "Start Calibration"
appears.
(1) Select the tube holder position for the calibrator vial and
rotate it to the 12 o'clock position.
(2) Now gently and thoroughly mix the calibrator material as
indicated on the instruction sheet that comes with the
calibrator.
o. Place the calibrator into the tube holder and press the "Start" key
on the front panel to initiate the cycle of the first sample.
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(1) The LCD display will indicate "Close the tube holder
door".
(2) When the cycle is done, the door will open so that the vial
can be removed for the next cycle.
p. Mix the material for the next calibration run.
(1) When the first sample is complete the results will display
on the screen.
(2) Press "Enter" to continue.
q. The next LCD will ask to "Accept" or "Reject" the results.
(1) Press "ESC" key to reject and start all over.
(2) Press "Enter" to accept the result and validate the results.
r. The display will then ask for the next calibration sample until the
calibration is complete.
s. Once the calibration is complete and has passed, press the "ESC"
key until the Main Menu is displayed.
t. Run the QC for the instrument.
2. RDW Calibration:
a. The RDW calibration is a separate calibration outside the
"Autocalibration" menu.
b. The RDW will be calibrated using ABX Minotrol.
c. Run the Normal Level Control 6 times, as a regular patient.
d. When the cycles are completed, calculate the mean value of RDW.
e. Calculate the new calibration factor using the mean in the control
package insert.
f. Enter the new value.
g. Run QC.
B. Linearity Verification (Linearity limits of the Horiba ABX are performed once
every 6 months):
1. Use the linearity standards for each assay.
2. The materials used for validation must be matrix appropriate material with
accurate target values that are specific for the method.
3. Follow the guidelines/instructions in the package insert for the material
used.
4. Compare the results obtained with the specific target values for the
parameters.
a. All levels are expected to be in the acceptable range given for the
standard.
b. The percent bias should not exceed the CLIA limits for that
parameter.
5. The test specimen must have analyte values which at a minimum are near
the low, midpoint, and high values of the analytic measurement range
(AMR). A minimum of five points should be used to cover the AMR.
6. Compare the results using linear regression analysis.
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7. Refer to the Linearity Validation Section of the Quality Assurance
Procedure, 104.1.
8. Successful verification certifies that the calibration is still valid.
Unsuccessful verification requires remedial action. Verify calibration.
9. Technical limits are posted on the instrument.
VI. References:
A. ABX Micros 60 CS/CT - User Manual, Horiba ABX, Montpellier, France,
9/2005.
236
Procedure Issue Date: 2/16/15 Applies to: Downtown
Last Revision Date: 2/16/15
Last Review Date: 2/16/15
Horiba Training Checklist EMPLOYEE: __________________________OBSERVED BY: ______________________
ASSESSMENT FOR THE TIME PERIOD: _______________ TO _____________________
□ COMPETENCY □ TRAINING
ITEM V W DO ACCEPTABLE
COMPETENCE
DATE INITIAL
YES NO*
1 Able to identify and explain function of analyzer components.
2 Identifies and explains overview of screens.
3 Understands the Uses of Resources: Instrument Manual and Laboratory Protocol.
4 Properly performs and documents the day of use and weekly (When in use) Preventive Maintenance procedure as
detailed in the procedure manual.
5 Knows the location, storage, and handling of reagents and consumable supplies.
6 Manages reagents and consumables and knows how to replace reagent container/consumables.
7 Demonstrates the location, storage, stability, and how to perform the result Quality Control and takes corrective action
when required.
8 Understands QA/QC Procedures:
Knows how to setup new lot numbers for controls.
Demonstrates proper handling of controls.
Understands how to run control.
Reviews QC results per laboratory protocol.
9 Processes Quality Control materials and patient samples:
Knows how to run control/sample using Single-tube Presentation with barcode ID and without.
Reviews sample results for flags, codes, or messages.
10 Understands specimen and processing requirements.
11 Recognizes abnormal results and confirms, phones, and documents critical values.
12 Identifies potential hazards and safety features, reviews MSDS, and recognizes hazard symbols.
13 Acceptable performance of an unknown and/or control analysis (attach results).
14 Practices Universal Precautions and exhibits compliance with all safety protocols.
15 Acceptable performance on written exercise (80%).
16 Review of written procedure (employee initials).
Assessment Method: V = verbal; W = written; DO = direct observation
*If unacceptable performance noted, please detail corrective action and achievement of acceptable competency.
Item #: _______________________ Date: _________________________
Corrective Action: __________________________________________________________
_____________________________________________________________________________
Employee: _______________________________________________ Date: ___________
Competency Officer: _____________________________________ Date: ___________
237
EVD Procedure
Procedure Issue Date: 2/16/15 Applies to: Downtown
Last Revision Date: 2/16/15
Last Review Date: 2/16/15
Piccolo Xpress General Operating Procedure
I. Principle:
a. The piccolo xpressTM
chemistry analyzer provides quantitative in vitro determinations
of clinical chemistry analytes in lithium-heparinized whole blood, heparinized
plasma, or serum.
b. The piccolo chemistry system consists of a portable analyzer and disposable single-
use reagent discs. Each reagent disc contains all the reagents needed to perform a
panel of tests on a single sample.
c. The piccolo xpressTM
analyzer uses centrifugal and capillary forces to process
heparinized whole blood samples and distribute diluted plasma to the reaction
chambers (cuvettes) in the reagent disc. Serum and heparinized plasma samples are
processed in a similar manner. The analyzer optically measures the chemical
reactions and calculates analyte concentrations from these measurements and from
encoded calibration data contained on the barcode ring on the reagent disc.
d. Results are stored in memory, and can be printed using the built-in thermal printer or
downloaded to an external personal computer for data management.
e. The touchscreen display provides easy communication with the analyzer. The
touchscreen shows procedural instructions, indicates the status of the analyzer, and
presents any error messages.
f. The reagent disc drawer slides out from the front of the analyzer, and transports the
reagent disc into the analyzer and automatically positions it for analysis.
g. The analyzer prints results on adhesive-backed thermal paper tape, through its
internal printer.
II. Specimen:
A. The piccolo xpressTM
chemistry analyzer accepts lithium-heparinized
whole blood, plasma, or serum samples.
1. Lithium heparin is the only anticoagulant recommended for use with the
piccolo xpressTM
.
2. Sample size: 90-120 µL
NOTE: When collecting the sample in lithium heparin collection tubes, fill the
tube at least half-way so the anticoagulant does not become too concentrated in
the sample.
B. Sample Storage:
1. Whole blood must be analyzed within 60 minutes of collection, or
separated into plasma or serum.
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2. To prevent hemolysis, do not refrigerate or shake whole blood.
3. If not analyzed immediately, plasma or serum can be stored at room
temperature for no longer than 5 hours after centrifugation.
4. If storage for more than 5 hours is required, refrigerate the sample in the
stoppered tube at 2-8°C (36-46°F) for no longer than 48 hours, or store it
at -10°C for up to 5 weeks in a freezer with no self-defrost cycle. Under
these conditions, there will be no clinically important changes in most
analyte concentrations.
C. WARNING: Operator health and safety regulations require Universal
Precautions be observed at all time while handling human blood samples or
working with the piccolo xpressTM
chemistry analyzer in any way.
III. Equipment - Special Supplies and Reagents:
A. Reagent Discs:
1. Disc Structure and Function:
a. In the piccolo® system, all chemistry reactions are performed
inside clear plastic reagent discs, 8 cm in diameter and 2 cm thick,
specially designed to perform all the steps required to convert a
few drops of whole blood, plasma, or serum into a panel of test
results.
b. Each disc contains all the components and reagents needed to
perform one or more tests on a single sample.
c. A total of 30 cuvettes are located around the periphery:
(1) Four system cuvettes contain QC reagent beads for
instrument and chemistry quality control.
(2) A minimum and maximum absorbance cuvette are used to
calibrate the spectrophotometer.
(3) A specially designed cuvette detects whether sample
volume was sufficient.
(4) A cuvette verifies that sufficient diluted sample was
delivered to the reaction cuvettes.
(5) An empty cuvette captures excess fluids.
(6) 21 cuvettes contain test-specific lyophilized reagent beads.
(a) The Bar Code Ring:
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i. That is attached to the top of the reagent disc
contains calibration data for the specific
chemistries in the disc.
ii. It also contains the disc identification code,
lot number, and expiration date.
iii. The analyzer automatically checks the code
and rejects any expired disc.
iv. The bar code ring also protects the optical
surfaces of the cuvette from fingerprints and
debris, and helps minimize contamination of
the analyzer by capturing small drops of
blood that may be on the disc surface.
(b) The Sample Port:
i. Is marked by an arrow pointing to a molded
circle on the disc's upper surface, and
provides access to the sample chamber.
ii. When sufficient sample has been loaded into
the sample chamber, the sample fill line
forms between two molded arrows on the
disc surface.
(c) Sample Diluent:
i. Is sealed in a container inside the center of
the disc.
ii. At the beginning of the reaction cycle, the
analyzer opens this container and releases
the diluent.
(d) Mixing Chamber:
i. The analyzer separates a lithium-heparinized
whole blood sample by centrifugation inside
the disc.
ii. Plasma and serum samples are unaffected.
iii. Precisely measured quantities of sample and
diluent are delivered to the mixing chamber.
iv. Centrifugal and capillary forces then deliver
the diluted sample to the cuvettes, where it
dissolves the reagent beads and initiates the
chemical reactions.
v. Reaction products in the cuvettes are then
measured photometrically.
2. Disc Storage and Handling:
CAUTION: Discs are fragile. Always handle with care. Do not tap discs
on the table or work bench to empty the sample port. Do not use a disc
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that has been dropped. Inspect every reagent disc for damage before use.
Never use a damaged disc.
a. Store each reagent disc as described on its label.
(1) This keeps the disc's reagents stable until the expiration
date printed on the disc's foil pouch and encoded in its bar
code ring.
(2) The analyzer automatically rejects any expired disc.
b. Discs can be used directly from the refrigerator (stored at 2-8°C)
without warming.
c. A disc can remain in its sealed pouch at room temperature for a
cumulative period of 48 hours. Longer time at room temperature
can cause suppression of chemistries and disc cancellations.
d. Do not expose discs, in or out of their foil pouches, to direct
sunlight or to temperatures above 32°C (90°F).
e. Inspect the unopened foil pouch for tears and punctures. A torn or
damaged pouch can allow moisture to reach the disc and reduce
reagent performance.
f. Open the disc pouch at the notch on the top right edge of the
package.
NOTE: The disc must be used within 20 minutes of opening its
pouch.
g. Once the pouch is opened, do not place the disc back in the
refrigerator for later use.
h. Keep discs clean.
(1) Handle them only by their edges to avoid smudges on the
optical surfaces.
(2) Use a lint-free tissue to remove any spilled blood from disc
surfaces.
i. Hold reagent discs flat after introducing the sample or control to
avoid spillage.
WARNING: BIOHAZARD: Used reagent discs contain body
fluids. Follow good laboratory working practices and universal
precautions.
B. Supplies:
1. Powder-free gloves
2. Micropipette
3. Kimwipes
4. 100 µL MLA pipette
5. MLA tips
C. Equipment:
1. piccolo® xpressTM
IV. Procedure:
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A. Analyzer Operation (The analyzer has a touchscreen display to operate the
analyzer.):
1. Use the ten numbers on the touchscreen to input patient information.
2. The left and right arrow touchscreen keys move the display cursor
forward or backward to change a number on the display.
a. The right arrow key functions as a dash(-) when entering a patient
identification number.
b. The left arrow key functions as a backspace.
3. Use the up and down arrow keys to scroll through a displayed list
of items, or to increase or decrease a displayed value.
4. Operating functions are available through various icons on the
touchscreen, as well as specific keys that appear on the touchscreen
according to the actions performed.
5. Press "Back" on the touchscreen to cancel a choice and return to the
previous screen, or to move backward through a series of screens.
6. Turn the analyzer's power on and off by pressing the power button on the
front of the instrument. (This button can only turn the power off if the
drawer is closed and there is no disc in the analyzer.)
7. The drawer opens or closes by pressing "Analyze" or "Close" on the
touchscreen. Closing a drawer containing a reagent disc initiates an
analysis.
8. Results for previously analyzed samples can be accessed using the
"Recall" function.
9. Information Icons:
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a. A number of the piccolo xpressTM
touchscreen displays include an
information icon that gives additional information about the
procedure being performed.
b. For example, in the screen that appears when a disc is loaded, press
the "Information" icon to view a screen outlining the basic analysis
procedure.
c. Press "Next" or "Back" to move through the information screens,
and "Exit" to close them.
B. Preparing the Reagent Disc:
NOTE: Analysis must begin immediately (no more than 10 minutes) after
dispensing the sample into the reagent disc.
CAUTION: Discs are fragile, always handle with care. Do not tap discs on the
table or work bench to empty the sample port. Do not use a disc that has been
dropped. Inspect every reagent disc for damage before use. Never use a damaged
disc.
1. Dispense the Sample:
a. Use a 100 µL MLA pipette and tip to dispense approximately 100
µL of sample into the disc via the sample chamber.
b. CAUTION: Wear powder-free gloves while handling reagent discs
or operating the analyzer. Powder can disrupt the analyzer's
optical component.
c. Fill the Sample Chamber:
(1) Place the pipette tip into the disc's sample chamber, and tilt
the disc to 45° with the sample port above the fill line, so
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that the entire sample flows into the sample chamber. The
tip should touch the sample chamber, as shown below.
(2) Dispense the sample from the tip with a slow, continuous
motion.
(a) Take care not to overfill the sample chamber.
(b) A 90 µL sample will fill the sample chamber and
form a line between the two arrows molded on the
disc.
(c) More than 120 µL of sample will overfill the
chamber.
(3) Discard the pipette tip into a biohazard container.
(4) Clean the reagent disc.
(a) Use a Kimwipe to remove any sample spilled on the
outside of the disc, taking care that the tissue does
not withdraw any sample from the sample port.
(b) Dispose of the tissue in a biohazard container.
CAUTION: Do not remove the sample and try to
reintroduce it into the disc.
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d. Place the prepared disc in the analyzer.
(1) Hold the disc by its edges in a flat position.
V. Calibration:
A. The piccolo xpressTM chemistry analyze is self-calibrating.
1. The bar code on the reagent disc contains the required information to
perform its calibration whenever a reagent disc is run.
2. Each reagent bead used in the disc is calibrated to a reference method
and/or reference material.
3. If the recommended procedures in the procedure manual are followed, the
analyte concentrations produced by the analyzer will be accurate.
VI. Quality Control Features:
A. Internal Quality Control Checks:
1. The piccolo xpressTM
includes quality control features such as optical
sensing and electronic feedback systems, to ensure that accurate results are
reported.
a. The analyzer performs tests on both internal components and the
reagent discs whenever the power is turned on and/or a reagent
disc is inserted.
b. Additionally, the analyzer continues to perform tests during
analysis.
c. Messages on the display or on the result printout warn of analyzer
malfunctions and possible errors or explain why no results are
reported.
2. Intelligent Quality Control (iQC):
a. The piccolo xpressTM
hardware performs an iQC test whenever
power is turned ON.
b. iQC ensures that all optics, flash, and circuit board components are
functioning properly and verifies the memory functions.
c. The analyzer performs this analysis only when the iQC confirms
that all components are functional.
d. A hardware malfunction message appears on the display if any
component malfunctions.
e. Statistical methods are incorporated into the analyzer software to
ensure the accuracy of the results.
f. The lamp flashes up to 13 time points for rate chemistries and
typically three time points for endpoint chemistries.
g. The distribution of flashes at each time point is analyzed and the
standard deviation is compared to a pre-determined limit to ensure
the analyzer is functioning properly.
3. Quality Control During Analysis:
a. During an analysis, the analyzer's internal components and the
reagent disc are checked to ensure the accuracy of the results.
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(1) piccolo xpressTM
Analyzer:
(a) The analyzer's photometer takes readings with the
light path obstructed and unobstructed to determine
the appropriate light intensity range, and then
checks that the range is within specification, before
analysis begins.
(b) It also continually checks the performance of the
motor, flash, and optics during analysis as well.
(2) Reagent Disc:
(a) The analyzer performs several tests on the reagent
disc during the analysis.
(b) These checks confirm:
i. Calibration factors
ii. Expiration date
iii. All reagent beads are present
iv. Timing of fluid movement through the disc
v. Diluent and sample mixing
vi. Sufficient sample has been applied to the
disc
vii. Reagent beads dissolve when mixed with
diluted sample
(c) Each reagent disc contains reagents to detect
exposure to extreme conditions such as temperature
and humidity.
i. The message "QC OK" is printed on the
result printout when results from these
reagents are within the expected ranges.
ii. Otherwise, no results are printed, and a "run
canceled" message is shown on the display.
(d) The analyzer monitors the performance of the
reactions.
i. For rate chemistries, the analyzer confirms
that the reactions are linear with time, that
the slope is within range, and whether the
substrate has been depleted.
ii. In endpoint chemistries, the analyzer verifies
the flatness (completeness) of the endpoints.
(3) Sample:
(a) Samples are checked for physical interference.
(b) The analyzer estimates the sample indices,
hemolysis, lipemia, and icterus using absorbance
readings for the sample at 340 nm, 405 nm, and 467
nm.
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(c) This information is then compared to the pre-
established limits for hemolysis, lipemia, and
icterus for each method.
(d) When all three indices are below these limits for the
method, the result for that method is printed on the
result card.
(e) When even one index exceeds the limit, the result
for the method is suppressed and the error condition
displayed as HEM, LIP, or ICT.
B. External Quality Control:
1. Refer to Quality Control and Proficiency Testing procedure 101.2.
a. The composition of the matrix must be such that the solution
closely matches that of the biological specimen for characteristics
of importance to the analyzer.
b. Control materials need to be stable and available in sufficient
volumes in multiple portions and over an extended period.
c. Assayed controls come with expected values of the analytes.
2. Handle the control as described in the control package insert. Call Abaxis
Technical Support for assistance in interpreting control results.
NOTE: Before a control can be run, a control level must be enabled in the
reference ranges.
3. Abaxis recommends control testing as follows:
a. at least every 30 days
b. whenever laboratory conditions have changed significantly
c. when training or retaining of personnel indicate
d. when test results do not match patient symptoms or clinical
findings
e. with each new lot (CLIA waived tests in waived status labs)
4. Samples and controls are run identically by the analyzer.
a. However, using the "Run Controls" option in the "Menu" function
stores control results separately from patient results in the analyzer
memory.
(1) The Recall function can be used to search for specific
control results without searching through all patient results
stored in memory.
b. Control results can be printed on a result card immediately after
the conclusion of the control run, or whenever the control run
results are
5. Controls can be run whenever the analyzer displays the Home Screen.
VII. Procedure:
A. Running Patient Samples:
1. Turn on the analyzer by pressing the "Power" button on the front of the
analyzer. Do this before removing reagent discs from the refrigerator.
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a. The analyzer starts up, then performs a self test.
b. If the analyzer needs time to warm the disc chamber to operating
temperature, the display shows "Warming Up".
c. When the analyzer reaches operating temperature, it displays
"Analyze" on the Home screen.
2. Press "Analyze" on the touchscreen to open the disc drawer.
a. The following messages are then displayed:
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3. After inoculating the sample disc place the disc in the recessed area in the
drawer.
4. Press "Close" on the touchscreen. The analyzer then closes the drawer.
5. Select the sample type from those shown in the display.
a. The figure below shows the default selections: "Patient" and
"Control".
NOTE: The correct sample type is necessary for results to be
interpreted correctly.
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6. Enter the patient MR number for the sample (up to 14 characters), then
press "Done".
7. The analyzer then checks the disc type, and begins processing the sample.
NOTE: If the disc is found to be of an incorrect type or expired, an error
message appears. Repeat the analysis with another disc of the correct
type.
8. When the sample is finished processing, the analyzer stores the results and
displays that the analysis is complete.
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9. By default, the analyzer automatically prints the results of the analysis.
a. If the results do not print automatically, they can be recalled from
memory and printed.
NOTE: Be sure to review the results printout for any suppressed
results, which are marked with these symbols: "~~~"
10. Press "Open" to open the disc drawer.
11. Remove the reagent disc from the drawer.
CAUTION: Dispose of the disc according to the lab's standard procedures
for human patient samples.
12. To analyze another sample, insert the new reagent disc and repeat the
above procedure.
13. When finished, press "Close" to close the drawer and return the analyzer
to standby mode.
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B. Canceling Analysis (Occasionally there may be a need to cancel an analysis in
progress):
1. Press "Cancel" on the touchscreen. The display asks for confirmation.
2. Press "Cancel" again to confirm. The analysis is then canceled.
a. The disc drawer then opens.
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3. Remove the disc from the drawer.
a. The analyzer is now ready to perform another analysis.
b. Press "Close" to close the drawer.
VIII. Reporting Results:
A. The results calculated by the analyzer are stored in memory and printed
automatically, and can also be recalled and printed later as needed.
B. The heading of the results printout includes information such as the reagent disc
type, test date and time, sample type, sample ID number, alternate ID number,
gender, age, operator ID number, disc lot number, and analyzer serial number.
The tests results section of the card is printed in four columns:
1. Chemistry Name
2. Analyte Concentration
3. Reference Range
4. Specified Units
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C. Each reagent disc contains reagents to detect exposure to extreme conditions such
as temperature and humidity. The Message "QC OK" is printed on the results
when results from these reagents are within the expected ranges. Otherwise, no
results are printed, and the analyzer opens the disc drawer.
1. Results outside the reference range are indicated in the results by an
asterisk (*) printed next to the analyte concentration.
2. Results outside the dynamic range are indicted in the results by a "less
than" symbol (<) printed next to the lowest value of the dynamic range, or
a "greater than" symbol (>) printed next to the highest value of the
dynamic range.
a. For example, the dynamic range of glucose is 10-700 mg/dL.
(1) A sample concentration of glucose below this range would be
printed as <10 mg/dL, and a concentration above this range would
be printed as >700 mg/dL.
(2) Results outside the dynamic range should be reported as being
below or above the value indicated.
3. The symbols "~~~" are printed in place of numbers when a result cannot
be determined - that is the result is suppressed.
a. A result may be suppressed:
(1) Due to improper mixing of a reagent bead with diluted
sample.
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(2) A nonlinear reaction, an endpoint of a particular reaction
not reached.
(3) A concentration outside the analyzer's capabilities.
b. When a chemistry is suppressed (~~~), the analyzer prompts the
operator to print an error report.
4. For the Lactate Dehydrogenase (LD) Assay Only:
a. Blood cells contain significant levels of LD, and therefore all LD
assays are sensitive to hemolysis caused by release of LD from red
blood cells.
b. In the following circumstances, the results are annotated to help
interpret LD activity in the presence of small amounts of
hemolysis.
(1) If HEM is greater than 50 and less than or equal to 100
mg/dL, the printed LD value is followed by an "H"
indicating additional influence from hemolysis.
(2) If HEM is greater than 100 and less than or equal to 150
mg/dL, the LD value is preceded by "<" and followed by
"H", indicating that the true LD recovery is less than
reported.
(3) If HEM is greater than 150, no result will be indicated and
only "HEM" will be printed.
5. HEM, LIP, or ICT is printed in place of the
analyte concentration if hemolysis, lipemia, or icterus,
respectively, has adversely affected the results.
a. HEM is also printed if hemolysis and icterus, hemolysis and
lipemia, or hemolysis, lipemia, and icterus have affected a
particular analyte.
b. Examine the sample indices to determine if more than one
interferent is affecting a particular result.
6. The sample indices are included at the bottom of the results printout.
a. These indices indicate the degree of hemolysis, icterus, and
lipemia found in the sample.
b. Hemolysis, icterus, and lipemia are measured on a scale of 0
(clear), 1+ (slight), 2+ (Moderate), and 3+ (gross).
D. If the sample is identified as hemolytic, a new sample can be collected and
another reagent disc run.
E. High Lipemia may be due to diet.
1. Ensure the patient has fasted for at least 12 hours before collecting another
sample.
IX. References:
Piccolo® xpressTM
Chemistry Analyzer, ABAXIS, 3240 Whipple Road, Union City, CA.
2007.
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EVD Procedure
Procedure Issue Date: 2/16/15 Applies to: Downtown
Last Revision Date: 2/16/15
Last Review Date: 2/16/15
Piccolo Xpress Preventive Maintenance
I. Principle:
The piccolo xpressTM
chemistry analyzer requires minimal maintenance. Regular
maintenance of the analyzer will assure reliable operation.
CAUTION: Abaxis recommends only the cleaning methods described in this procedure.
If for some reason another method is needed, contact Abaxis Technical Support
beforehand at 800-822-2947 to verify that the proposed method will not damage the
analyzer. Abaxis is not responsible for damage caused by non-recommended cleaning
methods.
II. Reagents - Supplies and Equipment:
A. Supplies:
1. Gauze
2. bleach
B. Equipment:
1. piccolo xpressTM
Chemistry Analyzer:
a. Check that the electrical outlet utilized for the analyzer is
grounded.
b. Check that the ambient temperature where the analyzer is located
is 15-32°C (59-90°F).
c. Do not disconnect the power to the analyzer while running a
sample.
d. Keep the analyzer drawer closed when not in use.
e. Do not attempt to repair the analyzer. This may void the warranty.
Refer to Troubleshooting Section of package insert for regular
maintenance.
III. Maintenance Procedure:
A. After every use:
1. Cleaning the Case:
a. Clean the analyzer with a gauze, dampened with a 10% bleach
solution.
b. Do not spray or pour any detergents, solutions or other liquids
directly onto the analyzer.
c. Always dampen the gauze, then apply to the analyzer.
2. Cleaning the Display:
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a. Clean the analyzer screen with a gauze dampened with 10%
bleach.
CAUTION: Do not use any cleaner containing alcohol. Do not
spray cleaner directly onto the display. Dampen the cloth instead.
3. Cleaning Spills:
a. Observe universal precautions when cleaning spills on the
analyzer.
b. Use bleach to clean spills, following the standard cleaning
guidelines.
B. Bi-Annually:
1. Cleaning the Air Filter (The air filter in the back of the analyzer should be
cleaned at least twice per year. Check the air filter more often than twice
per year if the analyzer is located in an environment with excessive dust or
dirt.):
a. Unplug the analyzer and remove the power cord from the back of
the analyzer.
b. Grasp the black mesh filter in the circular opening and remove it.
c. Wash the filter in warm soapy water and dry completely.
d. Place the clean, dry filter flat in the circular opening and push the
sides of the filter behind the edges of the circular opening.
e. Plug the power cord into the back of the analyzer.
f. Plug the power cord into the power source, and press the "Power"
button on the front of the analyzer.
(1) The analyzer will perform a diagnostic self test.
(2) It may take up to another four minutes for the heaters to
bring the analyzer disc chamber to operating temperature.
g. If the analyzer does not successfully pass the self test see "Run
Samples" in 107.3.1.
2. Updating the Analyzer Software: Refer to the Operators Manual, S 9.4.
3. Instrument Comparison:
a. Between instrument comparisons are performed every six months.
b. A combination of patient samples, controls, and calibrators can be
sued for each assay.
(1) The samples should include a low, normal, and high value
for each analyte to be compared. A total of five points
should be used to cover the technical range.
c. Run the samples on the Piccolo and with the main chemistry
analyzer.
d. Compare the two instruments using linear regression analysis.
Refer to the Method/Instrument Correlation Procedure, 104.6.
IV. References:
Piccolo® xpressTM
Chemistry Analyzer, ABAXIS, 3240 Whipple Road, Union City, CA.
2007.
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Instrument: Piccolo® xpressTM
Location:_______ Serial #: ______________ Date: _____________________
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
WEEKLY:
Clean the
Case
Clean the
Display
Clean
Spills
TECH
INITIALS
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Pathology-Core Laboratory
Number: 107.3.2
Page: 5 of 5
2/2/15 SG
Location: ____________ Year: _________________
MAINTENANCE LOG FOR ADVANCED Piccolo® xpressTM
OPERATI
ON
JA
N FE
B
MA
R AP
R
MA
Y
JUN
E
JUL
Y
AU
G
SEP
T
OC
T
NO
V
DE
C
BI-ANNUAL
Clean Air
Filter
Update
Analyzer
Software
Instrument
Compariso
n
TECH
INITIALS
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EVD Procedure
Procedure Issue Date: 2/16/15 Applies to: Downtown
Last Revision Date: 2/16/15
Last Review Date: 2/16/15
Piccolo Training Checklist
EMPLOYEE: __________________________OBSERVED BY: ______________________
ASSESSMENT FOR THE TIME PERIOD: _______________ TO _____________________
□ COMPETENCY □ TRAINING
ITEM V W DO ACCEPTABLE
COMPETENCE
DATE
INITIAL
YES NO*
1 Able to name and locate all components on the Piccolo
xpress: display panel, keypad, reagent disc, and printer.
2 Properly performs and documents the daily Preventive
Maintenance procedures as detailed in the Procedure
Manual.
3 Understands the location, storage, and stability of reagent
disc and liquid control materials.
4 Demonstrates knowledge on how to perform and record
Quality Control Protocol.
5 Understands Specimen and Processing Requirements.
6 Understands Loading Requirements.
7 Understands test results and familiar with Data Entry
Procedure.
8 Acceptable performance of an unknown and/or control
analysis (attach results).
9 Practices Universal Precautions and exhibits compliance
with all safety protocols.
10 Acceptable performance on written exercise (80%).
11 Review of written procedure (employee initials).
Assessment Method: V = verbal; W = written; DO = direct observation
*If unacceptable performance noted, please detail corrective action and achievement of acceptable
competency.
Item #: _______________________ Date: _________________________
Corrective Action: __________________________________________________________
Employee: _______________________________________________ Date: ___________
Competency Officer: _____________________________________ Date: ___________
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EVD Procedure
Procedure Issue Date: 2/16/15 Applies to: Downtown
Last Revision Date: 2/16/15
Last Review Date: 2/16/15
Upstate Outpatient & Ambulatory EVD Guidance:
Quick Reference, Ambulatory/Outpatient Rn Mgr. Checklist
a) Identify if patient is possible case (A suspected case is considered a confirmed case until
proven otherwise)
i) In the past 21 days has the patient been outside the United States?
ii) Has the patient been near other people who have been diagnosed with Ebola?
iii) Does the patient have the symptoms of Ebola?
(1) Temperature: Greater than 38.6 C or 101.6 F
(2) Severe Headache, Muscle Pain, Weakness, Diarrhea, Vomiting, Abdominal pain
Unexplained hemorrhage (bleeding or bruising)
b) IF QUESTIONS (#1 and #3 ) OR questions (#2 and #3) are answered positive please
contact supervisor and follow main EVD Guidance on ipage. (Utilize language line (464-
1454), on the speaker phone, if non-English speaking patient.)
i) Isolate: If positive for questions (#1 and #3 ) OR questions (#2 and #3) Isolate
Patient:
ii) Employee/clerk should don a blue procedural mask (Lawson #72043).
iii) Employee/clerk has patient don a procedural mask immediately
iv) Employee/clerk immediately notify Charge Nurse/Nurse Manager/Provider
v) Charge Nurse/Nurse Manager dons surgical mask and double gloves and reasks Ebola
Screening Questions
c) IF QUESTIONS (#1 and #3 ) OR questions (#2 and #3) are answered positive place
patient in designated isolation exam room with bed pan (or commode or urinal) and
telephone
d) In accordance with CDC Guidelines for Ambulatory areas there should be NO patient
contact after patient is placed in the designated isolation exam room.
i) Charge Nurse and/or Nurse Manager should place Ambulatory Services Stop sign
(F8890) outside exam room where patient is isolated
ii) A staff member will be assigned to sit outside the room where the patient is isolated.
Responsibilities:
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iii) The designated staff member assigned outside of the isolation exam room will be
responsible for maintaining Ambulatory or Outpatient EVD Suspected/Confirmed
Exposure Isolation Room Log, of all person(s) who enter the room where the patient
is isolated. Every effort should be made to NOT ALLOW ANYONE to enter the
room.
iv) Anyone who enters the designated isolation patient room MUST stay in the room
with the patient. If necessary Upstate University Police may be called for assistance
(464-4000).
e) Charge Nurse and/or Nurse Manager will contact/inform the following people, in the
order specified, and specific to the campus or site of the program:
i) For the Downtown and private clinics:
(1) Contact Dr. Waleed Javaid (pager: 467-4529 or cell: 447-3222)
(2) If Dr. Javaid is not available, contact Dr. Mitchell Brodey (cell: 382-3740).
(3) If not available, the Hospital Operator should be called and request the Infectious
Disease Consult Attending be contacted.
(4) The hospital Administrative Supervisor should be called at 464-1400 to institute
Incident Command.
ii) For the Community campus:
(1) Contact Dr. Mitchell Brody (cell: 382-3740).
(2) If Dr. Brody not available, contact Dr. Waleed Javaid (pager: 467-4529 or cell:
447-3222)
(3) If not available call the hospital operator to contact the Infectious Disease Consult
Attending.
(4) Call the Administrative supervisor to institute incident command office (492-
5480) pager (441-0108)
f) Infectious Disease physician will provide further direction.
i) If patient needs ADMISSION, Drs. Waleed Javaid, Mitchell Brody or Infectious
Disease Consult Attending will instruct the Charge Nurse and/or Nurse Manager to
contact the local health department (LHD, contact telephone numbers below), the
Administrative Supervisor (DT 464-1400 or CC 441-0108 ) and EMS (911) to
arrange patient transport.
ii) If the patient requires Quarantine: Once confirmation has been made related to
monitoring and/or quarantine, (Dr. Waleed Javaid, Dr. Mitchell Brody or the
Infectious Disease Consult Attending) will instruct the Charge Nurse and/or Nurse
Manager to contact the Local Health Department regarding the patient. Please
indicate when contacting the local health department that you are reporting a
“suspected case for monitoring and quarantine.”
g) If Plan is for Transport and Hospital Admission:
i) Infectious Disease physician will instruct the Charge Nurse and/or Nurse Manager to
call for transport (call 911).
ii) Please indicate when calling Department of Health and 911/EMS that there is a
“suspected Ebola patient that requires transport.”
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h) Notification – Contact Numbers – Local Health Department
i) Onondaga County Health Department (OCHD)
ii) Business Hours: 315-435-3252
iii) Evening Hours: 315-435-3236
i) (If unable to reach OCHD) NYS Bureau of Communicable Disease Control
i) Business Hours: 518-473-4439
ii) Evenings, weekends, holidays: 1-866-881-2809
iii) Follow and implement any additional recommendations
j) Presence and Disposition of Visitors and/or family:
i) If patient is a minor child, parent must stay with child.
ii) If spouse, partner or significant other is present with patient and asymptomatic, they
may be allowed to stay in the waiting room.
iii) If spouse, partner or significant other is present with patient and SYMPTOMATIC,
they should be masked and isolated in the same room with the patient.
Ambulatory or Outpatient Nurse Manager EVD Incident Checklist
Date
Completed
Task Notes
Registration/Reception
Employee/clerk dials language line for non-
English speaking patient, using speaker phone.
Employee/clerk asks patient ALL 3 questions
noted in the EVD Quick Reference Guide, in the
order noted. Patient replies to all questions. If
the answers create a high degree of suspicion do
the following.
Employee/clerk should don a mask.
Employee/clerk advises patient to don a mask.
Employee/clerk should contact Nursing
designee IMMEDIATELY to assess patient for
isolation.
Nursing designee must don a mask and double
glove and go to the registration/reception desk.
Nursing designee must re-ask the patient the
questions in Step 1 prior to leaving the
registration/reception desk. If non-English
speaking patient, please use language line and
speaker phone at the registration/reception desk.
If response to the prescribed EVD questions are
verified as a YES, the nursing designee must
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Date
Completed
Task Notes
place the patient in the designated isolated exam
room.
Patient Placement
Nursing designee should place Ambulatory
Services STOP sign (F8890) on exam room
door where patient is isolated.
Nursing designee will be assigned to be the
patient’s primary nurse.
Nursing designee will be assigned to sit outside
the room where the patient is isolated.
Nursing designee will be responsible for
maintaining a log, EVD Suspected/Confirmed
Exposure Contact Log (see ipage) , of all
person(s) who may have had accidental contact
with the patient or come within three feet of the
patient.
Notification:
If the answers create a high degree of
suspicion
Employee/clerk should contact area Supervising
Nurse as directed by nurse designee.
Supervising Nurse will call their onsite Consult
Provider and review and confirm responses to
the same three (3) questions in Step 1: EVD
Quick Reference Guide. They should go over
the questions asked with the employee/clerk and
nursing designee to make sure the questions
were appropriately asked and answered (i.e., not
just travel, but travel to at risk countries, etc.).
Once confirmation has been made by the
Consult Provider and Supervising Nurse
regarding the isolated patient, following
contacts will be made, dependent upon site:
For DOWNTOWN AND PRIVATE CLINICS,
Dr. Waleed Javaid (pager: 467-4529 or cell:
447-3222) should be contacted first. If he is not
available, Dr. Mitchell Brodey (cell: 382-3740)
should be contacted. If he is not available, the
Hospital Operator should be called and
Supervising Nurse should request the Infectious
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Date
Completed
Task Notes
Disease Consult Attending be contacted.
For COMMUNITY CAMPUS, Dr. Mitchell
Brodey (cell: 382-3740) should be contacted
first. If he is not available, Dr. Waleed Javaid
(pager: 467-4529 or cell: 447-3222) should be
contacted. If he is not available, the Hospital
Operator should be called and Supervising
Nurse should request the Infectious Disease
Consult Attending be contacted.
Infectious Disease physician (Dr. Waleed
Javaid, Dr. Mitchell Brodey or the Infectious
Disease Consult Attending) will instruct the
Supervising Nurse to contact the local health
department (LHD) and EMS, based on the
situation.
Contain and Isolate
A restricted entry sign (Ambulatory Services
STOP sign) indicating that a suspected Ebola
patient is isolated will be placed on the door of
the room in which a suspected Ebola patient is
located.
Nurse will be posted at the door to the patient’s
room to ensure the patient does not leave the
room. Under no circumstances should nurse
stop, impede or prohibit someone who is
determined to leave. Maintain a space with
suspected patient to ensure no physical contact.
Plan for Transport and Admission
Infectious Disease physician will instruct the
Supervising Nurse to call for transport and
notify the local and state health dept.
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Appendix A: EVD Decontamination Zone Room Diagrams
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4th floor direct admission entrance for EVD
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POC Lab on 8M
Upstate Hospital EVD Guidance Downtown Campus
CONFIDENTIAL: Protected by NYS Ed. Law 6527 & Public Health Law 2805-m NO REDISCLOSURE OF THE ABOVE INFORMATION IS ALLOWED.
Appendix B: Level 1 PPE: PAPR Initial Training Curriculum
1) Purpose
a) Upstate University Hospital establishes uniform procedures, in accordance with the Occupational
Safety and Health Administration (OSHA) Standards, 29 CFR Part 1910.134, Respiratory
Protection, for the appropriate selection, use, and care of respiratory protective equipment for
employees.
2) Employee’s use of PAPR for Ebola requires participation in the Upstate Respiratory Protection
Program. Employee clearance for the use of PAPR’s requires:
a) Completion of the Medical Evaluation Questionnaire for Respirator Use: Initial Clearance,
administered by Employee Health.
b) Completion of respiratory protection training.
c) At least specific Annual re-fresher training.
d) Training Objectives
e) Upon completion of training, employees shall be able to demonstrate a working knowledge of the
potential respiratory hazards and respirator requirements for their work areas. Employees shall
demonstrate proficiency in the proper use, inspection, maintenance, and storage of a respirator.
Employees shall understand the respirator’s limitations and capabilities, as well as any physical or
medical conditions that may limit or prevent the effective use of a respirator.
f) Respirator users will be trained in basic respirator practices by personal instruction as outlined in
Powered Air-Purifying Respirator Training Outline. Examinations shall be administered at the
end of each training session. Employees are expected to correctly answer eighty percent (100%)
of the questions correctly, and all missed questions are reviewed with the employee. A copy of
the exam shall be kept with the employee’s records. Training shall be conducted for employees
covered under the Respiratory Protection Program on an annual basis.
3) POWERED AIR-PURIFYING RESPIRATOR TRAINING OUTLINE
a) Purpose and Objectives i) This training outline will demonstrate the uses, capabilities, limitations, care, and
maintenance for powered air-purifying respirators used at Upstate (Sentinel XL HP )
ii) Upon completion of instruction, employees will be able to:
(1) Define the working principle of a PAPR and its components.
(2) Describe the operational limitations of PAPRs.
(3) Use, remove, and replace filters and battery packs.
(4) Conduct a pre and post operational inspections.
(5) Show proficiency with system assembly and PAPR donning.
b) Introduction i) Ambient air is drawn thru the belt-mounted filters/cartridges and passes through the breathing
tube connected to the hood or helmet. The filtered air passes over the user’s face and
maintains a positive pressure inside the hood/helmet at all times. The Sentinel XL HP is
designed to work with two external HEPA filter which only protects the user from dusts,
fumes, and mists. It has an internal battery that can be recharged
c) Operational Limitations i) Not for use in atmospheres that are Immediately Dangerous to Life or Health (IDLH).
ii) Not for use where oxygen concentrations are below 19.5% or above 21.5%.
iii) Not for use in working atmospheres that contain toxic gases or vapors when fitted with HEPA
filters.
iv) Never open the motor/blower unit of the PAPR.
d) PAPR System i) System equipped with:
Upstate Hospital EVD Guidance Downtown Campus
CONFIDENTIAL: Protected by NYS Ed. Law 6527 & Public Health Law 2805-m NO REDISCLOSURE OF THE ABOVE INFORMATION IS ALLOWED.
(1) Hood
(2) Breathing Tube
(3) HEPA filters
(4) Motor/Blower
(5) Belt
(6) Replacement parts demonstration
ii) Remove and insert the battery.
(1) Replace the HEPA filters ensure that a filter gasket is located in each recess.
(2) Check hose for gaskets
(3) Snap the back cover into place.
e) Pre-Operational Inspection i) Prior to the beginning of each work shift, an inspection of the PAPR should include:
(1) Inspection of breathing tube, connections, and body.
(2) Inspection of filter(s)/cartridge(s) to make sure they are/it is correctly installed and the
battery is fully charged.
ii) Air flow
(1) Remove the air tube and insert the air flow indicator into the blower opening.
(2) Turn the blower on.
(3) The plastic cone should rise above the minimum flow mark.
(4) If the indicator fails to rise to this level, check the breathing tube, battery, and make sure
the caps are removed from the filters/cartridges.
f) System Assembly and Donning
i) Assemble in non-contaminated environment.
ii) Check that the breathing hose thread has the black rubber gasket seal present
iii) Check that the thread in the blower unit is in good condition and clear of foreign matter
iv) Screw the end of the breathing hose into the blower unit until it is hand tight Do not over
tighten!
v) To connect the tube to the head piece, screw the end of the breathing hose until it is hand
tight
vi) Properly donning the PAPR:
vii) Place the unit against your lower back and along your spinal column.
viii) Holding it in place, fasten the belt buckle and ensure the unit rests comfortable against
your back and turn the unit on.
ix) Turn unit on.
x) Pull the hood or helmet over your head and adjust it so the sweatband is on your forehead and
the elasticized edge of the face seal fits under your chin. The face seal is pulled as far as
possible under your chin and snug around your face.
xi) Tuck the inner bib inside the suit.
xii) WARNING: (1) Protection against airborne contaminants is not provided unless the hood/helmet is
correctly positioned over your head and the visor and face seal are correctly positioned in
front of your face. An adequate supply of filtered air must be maintained at all times.
(2) If the airflow ceases, decreases, or suddenly increases, leave the work area immediately
and check the hood, breathing tube, and motor/blower unit.
g) Filter/Cartridge Replacement for PAPR
i) Change the filter:
ii) When an airflow check of the unit reveals that the airflow indicator does not rise above the 6
CFM level.
iii) When the filter is physically damaged.
Upstate Hospital EVD Guidance Downtown Campus
CONFIDENTIAL: Protected by NYS Ed. Law 6527 & Public Health Law 2805-m NO REDISCLOSURE OF THE ABOVE INFORMATION IS ALLOWED.
iv) When water has entered the filter or cartridge.
v) Filter/Cartridge Replacement
vi) Make sure you line up the threads properly and screw on slowly.
vii) Do not over tighten.
viii) Remove caps.
ix) WARNING: (1) If the equipment is not properly assembled and used in strict conformance with the
manufactures specifications, contaminated air may be drawn into the system resulting in
exposure that may lead to serious health impairment or death. (MISUSE MAY RESULT
IN SICKNESS OR DEATH.)
(2) HEPA filters are only approved for protection against dust, fumes and mists.
h) Air Hepa Mate Battery Pack Use, Removal, and Replacement i) Completely exhausted battery should be charged for 4-6 hours.
ii) Repeated charging for more than 16 hours may reduce battery pack life.
iii) When fully charged, the battery should last at least ?? hours.
iv) Replace battery every three years.
v) Removal of battery pack:
(1) Remove the back cover..
(2) Slide the battery clip out of the locking slot.
(3) Lift the battery out.
i) Post Operational Maintenance 4) Wipe the outside of the unit using a bleach wipe.
5) ABRASIVE CLEANERS MUST NOT BE USED.
6) Properly discard cartridges/filter(s).
7) Disassemble the breathing tube from the headpiece.
8) Separate the tube from the unit.
9) Hang breathing tube to dry.
10) After all components have been cleaned, inspect all parts for damage or wear, and replace
worn parts.
11) Dry all parts completely, keeping them away from sunlight and direct heat.
POWERED AIR-PURIFYING RESPIRATORS TEST
Name: _________________________ID#: _______________________Date: _______________
1. The airborne hazards must be known before wearing a PAPR.
A) True
B) False
2. What does a PAPR fitted with High Efficiency (HE) filters provide protection from?
A) Gases and Vapors
B) Atmospheres below 19.5% oxygen
C) Atmospheres Immediately Dangerous to Life or Health (IDLH)
D) Particles
3. Which of the following statements is incorrect?
A) PAPRs may only be used in ambient air atmospheres where the oxygen concentration falls
between 19.5% and 21%
B) PAPRs are not for use in atmospheres which are Immediately Dangerous to Life or Health
(IDLH)
C) Any manufacturer can be used for replacement parts on any PAPR
D) You must know the contaminant you could potentially be exposed to before wearing a PAPR
4. Prior to wearing your PAPR, you should:
A) Inspect the breathing tube, body, and unit casing
Upstate Hospital EVD Guidance Downtown Campus
CONFIDENTIAL: Protected by NYS Ed. Law 6527 & Public Health Law 2805-m NO REDISCLOSURE OF THE ABOVE INFORMATION IS ALLOWED.
B) Check the airflow by using the airflow indicator (bullet)
C) Wash the entire HEPA unit in the sink with mild detergent
D) A and B
5. After you finish wearing your PAPR, you should:
A) Wipe it down with an abrasive cleaner
B) Follow the appropriate decontamination procedures as instructed
C) Use dust spray and a cloth to wipe it down
D) Use acetone to wipe it down
6. The PAPR airflow is adequate if:
A) The plastic cone floats above the lowest raised line
B) The battery has not been placed on the charger for several days
C) The plastic cone does not float
D) Air is coming out of the tube
7. If the airflow ceases while wearing the PAPR, you should:
A) Check the power by turning the ON/OFF button on the battery
B) Leave the work area immediately
C) Wait until you finish your job
D) Ask a fellow employee to check the PAPR
8. Change the filter when:
A) An airflow check of the unit reveals that the airflow indicator does not rise to the specified
level, yet the battery is fully charged
B) The filter or cartridge is physically damaged
C) Water has entered the any of the filters or cartridges
D) All of the above
9. A completely exhausted battery pack should be charged for the following time period:
A) One hour
B) 4-6 hours, or the period noted in the operating manual
C) 48 hours
D) Never – battery packs don’t get exhausted
10. Care should be taken when handling PAPR components, including the batteries (e.g. do not drop on
the ground, etc.).
A) True
B) False
Upstate Hospital EVD Guidance Downtown Campus
CONFIDENTIAL: Protected by NYS Ed. Law 6527 & Public Health Law 2805-m NO REDISCLOSURE OF THE ABOVE INFORMATION IS ALLOWED.
Appendix C: Upstate EVD Steering Committee Improvement
Process/Drill Planning
Drill Implementation & Design Process
1) Upstate EVD process/guidance approval and testing
a) Identify needed process/issue or equipment that staff needs to practice to improve
familiarity and performance.
b) Emergency Management will identify stakeholders and “owner” of the process (if one is
not apparent guidance will be provided by EVD steering)
c) A meeting will be help by Emergency Management with all available stakeholders in
order to
2) Define process.
a) Write an initial draft procedure
b) Identify necessary personnel for testing the procedure prior to offering the drill to other
staff members.
c) Emergency Management will schedule and perform draft procedure with stakeholders in
space where procedure will occur
d) Emergency Management will adjust any identified concerns after initial “walk thru”
e) Retest as needed
f) Emergency Management will present draft to Clinical Advisory group for approval.
g) Final draft will be presented EVD Steering for approval.
h) Drills will be scheduled for rollout to all required staff members as soon as practical
i) Any revisions or improvements identified during additional drills will be updated in the
policy once approved by EVD steering
3) Goal: This document is intended to define a set process in which clinical, support and other
staff members can test various components of Upstate Hospitals Ebola response plan. With
the ever increasing complexity of personal protective equipment coupled with a dynamic
clinical environment the need for clear and concise drills becomes paramount.
4) Definitions:
a) Tabletop Exercise – A tabletop exercise involves key personnel discussing simulated
scenarios in an informal setting can be used to assess plans, policies, and procedures.
b) Drill – A drill is a coordinated, supervised activity usually employed to test a single,
specific operation or function within a single entity (e.g., donning and doffing PPE)
c) Full-Scale Exercise – multi-agency and/or multidiscipline exercise involving "boots on
the ground" response (e.g., nursing decontaminating mock victims).
d) After Action Report (AAR) - is the final product of an exercise which captures
observations and recommendations based on the exercise objectives as associated with
the tasks identified
e) Improvement Items- a question, process and/or performance concern that is identified
during the physical act of the drill. A root analysis of each must be identified in order to
improve overall performance or ensure process success under “real world” conditions.
5) Process:
Upstate Hospital EVD Guidance Downtown Campus
CONFIDENTIAL: Protected by NYS Ed. Law 6527 & Public Health Law 2805-m NO REDISCLOSURE OF THE ABOVE INFORMATION IS ALLOWED.
a) A specific group or individual has identified a particular problem, question or issue that
requires some level of physical testing or equipment usage in order for that specific
process to become more efficient or safer.
b) That group or individual that has identified a particular testing opportunity must then
c) Write down specific steps of that process as they see it happening.
d) Create a checklist of movements or actions in order using existing materials or
experiences from other EVD/ID centers to assist in writing a task list.
e) Send an email to EVD Drill Coordinator indicating the following with as much detail
as possible. (SEE SAMLE EMAIL FORMAT BELOW)
f) The specific goal of the drill. Is the goal to see if something can be done in a specific way
or in a set amount of time?
g) What is the desired level of staff/equipment performance or expected outcome?
h) A copy of the written standard or process to be tested that the group has developed.
i) Date in which drill needs to be completed.
j) Identify specific groups/departments that would perform the skill and any personnel that
would be involved in processing or assisting.
k) The specific area in which this skill/process is to occur. (8m, GEM Care, ED, etc.)
l) What equipment is needed for staff to perform the drill?
m) What factors would make the environment as realistic as possible? Are there any
environmental factors that cannot be replicated during the drill?
n) Who would need to be present at the drill in order to audit or facilitate the exercise?
o) Once the request for a EVD Drill has been received the Drill Coordinator will
p) Identify or clarify any issues with drill request
q) Recruit staff/designate roles for drilling. Coordinating with Training and Clinical Staff
managers to reduce duplication of training and ensure a minimal impact on normal
operations.
r) Prepare equipment or ensure needed equipment is available
s) Reserve designated drilling space ensuring minimal impact to Upstate’s “day to day”
operations.
t) Designate additional facilitators or evaluators as the requirements of the drill determine.
u) Ensure the role of safety officer is been identified prior to the start of every drill.
6) During Drill
a) The Drill Coordinator will brief participants on Goals, expectations, environmental
factors and overall safety before beginning.
b) The Drill Coordinator will also record any issues or new questions as they are mentioned
by staff participating during the drill.
7) After the Drill
a) Evaluations or discussion points will be collected by the Drill Coordinator immediately
after the session has completed. A brief after action report will be created and kept on
file with the Department of Emergency Management.
b) Once all the improvement items have been compiled
c) The Drill Coordinator will list a summary reporting to the EVD Steering Committee.
d) A recommendation will be made to the committee from the EVD Drill Coordinator as to
whom each item should be assigned in order to reach a resolution or level of completion.
e) A copy of all improvement items identified will be sent to the drill requesting/originating
individual or group along with a copy of the AAR.
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f) Once at the EVD steering committee level all improvement items will be reviewed
weekly.
g) Completion progress will be monitored for those individuals assigned.
h) Additional resources will be assigned by the EVD steering committee as needed in order
to complete outstanding improvement items.
8) EMAIL FORMAT TO BE SENT TO EVD DRILL COORDINATOR:
a) GOAL OF DRILL:
i) What is the desired level of performance or expected outcome:
ii) Date in which drill needs to be completed:
iii) List Departments that need to participate:
iv) The specific area drill should be held: (8m, GEM Care, ED, etc.)
v) What equipment is needed for the drill?
vi) What additional factors would need to be changed to make the environment as
realistic?
vii) Are there environmental factors that cannot be replicated?
viii) Are there specific supervisors who need to be present in order to audit or
facilitate?
ix) Attach a copy of the written standard or process to be tested
9) All process improvements, once approved by the EVD Steering Committee, will be
communicated to all Upstate staff members via the EVD button on the ipage.
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Appendix D : Upstate Departmental Disaster Plan 8M
EMERGENCY RESPONSE PLAN
COMPREHENSIVE EMERGENCY
MANAGEMENT PLAN
POLICY: a. The 8m Infectious disease unit will follow the recommended guidelines in the
event that Incident Command is initiated at University Hospital at the
Downtown Campus as detailed in policies DIS C-00 and DIS J-12.
1. DISASTER DEFINITIONS:
a. Level I- Pending Disaster situations can be effectively handled by personnel
currently on duty.
b. Level II- Pending Disaster situations cannot be effectively handled by
personnel presently on duty at the time of the crisis.
c. Disasters are also categorized by the source of the situation.
i. External: Response to something that has happened in the
community.
ii. Internal: Response to something that has happened within the
hospital that requires a coordinated response.
2. NOTIFICATIONS:
a. When Incident Command has been activated, personnel will be notified by
email, fax, phone, overhead page and/or by person. Personnel will be
expected to return to their work area. (See DIS J-12 for more information).
b. At the conclusion of the incident, “Code CLEAR” will be given via email, fax,
phone overhead page, and/or by person. Personnel will be expected to
resume normal activities after that announcement.
4. EXPECTED RESPONSE:
a. These steps should be taken when Incident Command is activated:
i. Assess your current operational status.
ii. Report any operational problems through your chain of command or
Incident Command.
iii. If your unit/department is the scene of a fire or disaster perform an
immediate headcount of staff (and patients) to give to University
Police and Community First responders (Fire Department, Bomb
Squad, etc.) upon their arrival.
iv. Inform your staff that shifts have been extended to 12 hours until
further notice. Do not release the end of shift staff until told to do so
by the incident commander.
v. Continue normal operations unless instructed (or unable) to do
otherwise.
vi. If you are away from your work area, return to it and report in.
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vii. Do not send staff to the Labor Pool, Hospital Administration or scene
until directed to do so.
viii. Ensure someone at the department level is assigned to monitor their
own e-mail and the department fax machine for disaster related
communications.
b. Maintain a heightened sense of awareness to:
i. Changes in the environment.
ii. Overhead announcements, faxes or e-mails.
iii. Operational problems.
iv. Reaction of staff, patients, families.
v. Observe staff for signs of stress.
5. STAFFING:
a. Staffing information can be accessed via Self Serve through the University
Hospital webpage.
b. If staff needs to be recalled in response to a Level II Disaster, remind them to
report to the Labor Pool upon arrival at the hospital (the specific site will be
determined at the time of the incident).
c. Notify 8m Supervisor or Administrative Supervisor as soon as possible to
ensure appropriate staffing
6. EMERGENCY/DISASTER OPERATIONS:
a. Continue normal operations unless instructed or unable to do otherwise by
Incident Command or Fire Department Personnel.
b. Assess current operational staffing status requirements and report
operational issues/concerns to Administrator or the Incident Command
Center.
c. Fire or Disaster:
i. Use nearest pull alarm box if you are able.
ii. Call 4-5555 in the hospital and 9-911 external….Do not hang
up…..Give specific location of fire.
iii. For Disaster call 4-8888 if Incident Command has been activated.
iv. Examine Environment.
v. Evaluate if oxygen needs to be shut off.
vi. Turn off all unnecessary electrical equipment.
vii. Clear corridors of all equipment and obstacles.
viii. Close all windows and doors.
ix. Shelter in place and monitor through overhead page and IC.
x. In the event of a fire or other event on 8m move the patient two smoke
compartments with staff in full ppe.
xi. All staff- not directly involved in the patient move should evacuate
through the south 8m exit.
xii. If the patient is to be moved from 8m – if possible move the patient to
the ED Room A1/A2 EVD designated areas.
xiii. Coordination of this movement with Incident Command is critical
d. Evacuation Plan: (See Policy DIS M-40 for more information)
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NEVER hesitate to relocate because of imminent
danger e. DO NOT USE ELEVATORS, (unless specifically instructed to do so by the
Fire Department).
h. During an evacuation of patient areas, patients should be prioritized for
evacuation in the following manner:
i. Patients and Visitors in Immediate Danger
ii. Ambulatory Patients
iii. Wheelchairs, Isolettes, Cribs
iv. Bed Bound Patients
i. Total Facility Evacuation: Evacuation of the entire hospital would be
coordinated and directed through Incident Command.
7. EDUCATION:
a. All Staff will complete Safety at Work (SAW) and review the Departmental
Disaster Plan annually. (See M04 Mandatory and Staff Education for more
information on required Incident Command Training for all staff.)
8. Emergency Code Names:
9. DEPARTMENT SPECIFIC PLANS AND PROCEDURES:
a. Minimal Staffing in a Disaster:
i. Follow the directions issued by the Administrative Administrative
Supervisor or Incident Commander concerning preparation of
patients for transfer or discharge.
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ii. The 8m Supervisor will determine what staffing is needed to continue
to operate.
iii. If the nature of the disaster is such that 8m needs additional staff, the
Supervisor will notify Incident Command immediately.
Originating Department: 8m EVD Steering Committee
Contributing Department(s): Emergency Management
References: none
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Appendix E : Upstate EVD Training Tracker Codes
Compiled by: Org. Training and Development
Training Intended Audience Tracker Code
DRILLS
8M Drill Assisting Staff Member
in Emergency EBOLAASSIST
8M Drill Spills EBOLASPILLS
8M Drill Waste EBOLAWASTE
8M Drill X-ray EBOLAXRAY
8M Drills (Instructor Sign Up) Ebola PPE SuperUsers sign up to
support 8M Drill EBOLA8M
8M Drill PAPR EBOLAPAPR
8M Drill Phlebotomy EBOLAPHLEB
Ebola Drill EBOLADRILL
1/2015 tracking all 8M drills under
this code for consistency and
monthly report to Dave Anthony EDUCATION
Blackboard web-based related to
screening of patients
Registration and UPD staff EBOLAREG
1/21/2015 – Blackboard course
turned off
Ebola Fast Facts - November
2014 (Both Campuses) EBOLAFF
Full Ebola PPE Staff requiring PPE training EBOLAPPE
EDUCATION CHANGES EFFECTIVE 3/1/2015
Level 1 PPE: includes PAPR An Upstate employee directly
engaged in the care or support of
a patient with EVD (Nurse,
Physician)
EBOLAPPE1
Level 2: includes N95 An Upstate employee directly
engaged in the care or support of
a patient with EVD (Nurse,
Physician)
Some Environmental
Services
EBOLAPPE2
Level 3: Suit Buddy Primarily tasked with actively
monitoring and assisting the
HCW/Staff member with
correctly donning and doffing
PPE, observing staff members for
increased fatigue or possibility of
injury, breaks in PPE and
measuring vitals of the primary
staff member prior to donning
and after doffing.
EBOLAPPE3
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Training Intended Audience Tracker Code
Laboratory
Some Environmental
Services
Trained Observer To provide direct onsite
management and oversight for
the overall safe operation of all
staff members engaged in the
care of an EVD patient.
EBOLAOBSERVER
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Appendix E: Rural Metro EMS EVD Policies
EBOLA VIRUS DISEASE (EVD) PROTOCOL
The enclosed policy is developed from CDC’s Oct. 1, 2014 Interim Guidance for EMS Systems & 911 PSAP’s,
NYS DOH planning considerations, SUNY Upstate collaboration agreement and CNY Regional Emergency
Medical Advisory Committee’s Dec. 4, 2014 Ebola advisory. Further updates will be issued, reviewed and amended
as they become available.
Ebola Virus Disease (EVD) – is one of numerous Viral Hemorrhage Fevers. It is a rare, severe, often deadly illness
caused by infection with a virus of the family Filoviridae, genus Ebolavirus. Early recognition of Ebola is critical for
infection control. EMS providers should be alert for and evaluate any patients suspected of having EVD.
Background (World Health Organization, 2014)
The current outbreak in West Africa (first cases notified in March 2014) is the largest and most complex Ebola
outbreak since the Ebola virus was first discovered in 1976. There have been more cases and deaths in this outbreak
than all others combined. It has also spread between countries starting in Guinea then spreading across land borders
to Sierra Leone.
EVD may spread to other countries before the outbreak is contained. Patients are not contagious prior to the
development of symptoms. Patients can transmit the virus from onset of fever and through later stages of the
disease, as well as post mortem. Recovery from Ebola depends on good supportive clinical care and the patient’s
immune response. People who recover from Ebola infection develop antibodies that last for at least 10 years.
Current Situation:
NYS Department of Health has designated SUNY Upstate (Downtown) Medical Center as an Ebola care hospital for
the 14 upstate counties. SUNY Upstate is one of 10 designated Ebola hospitals in NYS. SUNY Upstate has selected
R/M of CNY to be its lead EMS agency to support a Regional Response Team approach for emergency medical
response and inter-facility transportation.
Travelers are routed to five United States airports in which their passports are scanned. At JFK Airport, if positive
travel from one of the three countries stated above, they will be screened by CDC, and then screened again by NYS
DOH where a risk level will be determined (i.e. low, moderate, or high risk). The NYS DOH will notify the
respective county/local health department(s) of a traveler within their region. SUNY Upstate and R/M are then
contacted and provided a brief on these travelers in the region.
Transmission (CDC and Prevention, 2014)
Ebola is spread through direct contact (through broken skin or mucous membranes i.e. eyes, nose or mouth) with:
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Blood or body fluids (including but not limited to: urine, saliva, sweat, blood, vomit, semen, feces and
breast milk) of an infected person.
Objects (i.e. needle and syringes) that have been contaminated with the virus
Infected animals, in Africa, EVD may be spread as a result of handling bush meat (wild animals hunted for
food) and contact with infected bats. There is no evidence that mosquitos or other insects can transmit
Ebola virus. Only mammals (i.e. humans, bats, monkeys & apes) have shown the ability to become
infected with and spread Ebola virus.
Ebola is not spread through the air or by water, or in general, by food. However, airborne transmission of
the virus may occur during aerosol-generating procedures. Signs & Symptoms of EVD
Fever (100.4 degrees F) Severe headache
Muscle pain Weakness
Diarrhea Vomiting
Abdominal (stomach) pain Unexplained hemorrhage (bleeding or bruising)
EVD symptoms can appear from 2 to 21 days after exposure, but the average is with 8 to 10 days.
Person Under Investigation (PUI)
A person who has both consistent signs or symptoms and risk factors as follows:
1. Elevated body temperature or subjective fever or symptoms, including severe headache, fatigue, muscle
pain, vomiting, diarrhea, abdominal pain or unexplained hemorrhage; AND
2. An epidemiologic risk (i.e. positive travel to an EVD country or contact with a person with EVD) factor
within the 21 days before the onset of symptoms
Dispatch Screening:
To keep EMS providers safe, the Onondaga County’s Emergency Communications 911 Center and R/M’s Dispatch
Center will use modified caller queries to screen for EVD. Call takers should ask:
1. Has the patient traveled out of the country in the last month (specifically to West Africa [ Sierra Leone] or
another area where EVD has been reported) or has the patient come in contact with a sick patient who has been
out of the country in the last month.
2. Does the patient have any of the following symptoms:
Fever of greater than 100.4 degrees F (38 degrees C)
Severe headache
Unexplained muscle pain
Vomiting, diarrhea, abdominal pain
Unexplained medical hemorrhage
If Question 1 & 2 is answered yes, the patient is: ‘High Risk Illness with Travel’
If Question 1 is answered yes only, the patient is: ‘Moderate Risk Illness with Travel’.
If Question 1 is yes to positive travel, but no to EVD contact; the patient is: ‘Low Risk Illness’.
Notification:
County 911 will notify R/M via phone and in their Emergency Medical Dispatch (EMD) case entry notes that the
Emerging Infection Disease Syndrome (EIDS) tool is being utilized on this call. The EIDS tool is being used by all
call takers for documenting potential concerns as related to EVD. R/M will then dispatch a suspected Ebola call as
an illness over the air, but write in on the crew’s pagers potential EVD call. The EMS crew will be instructed to call
dispatch before arrival on scene to advice of the potential for a patient with possible exposure/signs & symptoms of
Ebola. Do Not use ‘Ebola’ word over an open radio channel and EMS should call Resource via phone patch.
SUNY Upstate has stated they would prefer a phone patch to communicate.
R/M Dispatch will ask County 911 for the Syracuse Fire Department’s Haz-Mat is dispatched to the scene within the
City of Syracuse suspected EVD calls. R/M will notify Onondaga County Health Department that R/M is
responding to a potential EVD patient with positive travel and positive symptoms. R/M Dispatch will call SUNY
Upstate Hospital EVD Guidance Downtown Campus
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ED to notify Upstate of Highly suspected case. For suspected EVD 911 calls and inter-facility EVD transports,
R/M Support Service’s Manager and SUNY Upstate’s Director of Emergency Management will communicate so
SUNY’s staff is allowed sufficient time to coordinate their internal preparation of receiving an EVD patient.
Regional Plan for R/M as the Ebola EMS Agency
As stated in the introduction, SUNY has selected R/M to be the lead EMS Agency to support the regional approach
to emergency medical response and provide inter-facility transportation for EVD patients within the 14 upstate
counties.
The Core Mission of this Regional approach program is to:
1. To protect the health and safety of our EMS providers.
2. To provide persons under investigation (PUI) or patients with diagnosed EVD, with appropriate care
while limiting the possibility of further contagion.
R/M has developed a team of Bio-Techs to perform these regional responses. They have received proper education
on the current Ebola monitoring process in NYS, reviewed CNY’s Ebola field care, understand the direct admit
process at SUNY Upstate, successfully donned & doffed R/M’s full protection PPE and exercised with SUNY. R/M
has also participated in an informative Ebola update and exercise with NYS Department of Health – Central Region.
In this WebEx, the 14 counties within the Central NY region were represented and know that SUNY is the dedicated
CNY Ebola hospital and that R/M is the lead EMS Ebola transport agency.
EMS – Prior To Arrival at Patient
Considerations for Infection Control and PPE
If 911 or R/M dispatch advises the patient is suspected to have Ebola, the EMS crew should put on
appropriate PPE (personal protection kit: double gloves, impermeable gown, eye protection and N-95
mask. Avoid direct contact with a patient who may have Ebola without wearing appropriate PPE.
PPE should be put on before entering a scene to attend to a suspected EVD patient and continued to be
worn until providers are no longer in contact with the patient. PPE should be put on and off under the
supervision of a trained monitor. The Shift/Assistant Commanders and the Support Services Manager can
be a trained monitor. See Attachment: Donning & Doffing
Limit the number of EMS providers to essential personnel only who provide care for a patient with
suspected EVD. Again,
Keep the patient separated from other persons as much as possible.
One EMS crew member should approach the patient and perform the initial screening from at least 3 feet
away from the patient.
Use caution when approaching a patient with possible EVD. On rare occasions, illness can cause delirium,
with erratic behavior (i.e. flailing or staggering) that can place EMS personnel at additional risk of
exposure.
There may be situations where a patient must be carried and multiple providers are required to put on PPE.
Any provider (EMS and/or Fire) wearing PPE who have cared for the patient must remain in the back of
the ambulance (patient compartment) and should not serve as the driver.
Occupational Exposure
If blood, body fluids, secretions, or excretions from a patient with suspected EVD come into direct contact
with an EMS provider’s unprotected skin or mucous membranes, then the EMS provider should
immediately stop working and:
- immediately wash the affected skin surfaces with a cleansing or antiseptic solution. Mucous
membranes should be irrigated with a large amount of water or eyewash solution.
All wipes should be red bag (meeting ASTM 1922 and ASTM1709 standards for 480 grams tear resistance
and 165 grams of impact resistance.) ged. The solution run off should be left on the 6 mil plastic and when
at SUNY Upstate, carefully remove the plastic from the patient compartment and place within one of
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SUNY’s 55 gallon bio-waste drums. Note: the patient stretcher is to be decontaminated including the
wheels.
Place all waste in a red bag (meeting ASTM 1922 and ASTM1709 standards for 480 grams tear resistance
and 165 grams of impact resistance.) .
Notify the Shift Commander of the exposure and report the exposure to the receiving hospital (SUNY).
Follow agency policy for medical evaluation and follow-up care and monitoring. Note: Onondaga County
will be involved with the monitoring.
EMS Arrival at Scene & Field Care
STEP 1. No EVD suspected from 911 or R/M Dispatch and no risk factors, proceed with normal EMS care.
a. Minimum Basic PPE: gloves and mask for ALL respiratory complaints
b. Perform EMS screening from >3 feet from all patients
See Attachment: Field Personnel Ebola Screening Questionnaire
i. If patient screens Moderate Risk Illness with Travel:
Follow CNY protocols, maintain basic PPE, brief Resource on patient history/symptoms
and ETA, this will allow SUNY Upstate staff to prepare to receive.
ii. If patient screens High Risk Illness with Travel:
Remove EMS crew from environment, contact Resource & advise on history/symptoms
and ETA
GO TO STEP 3 BELOW
STEP 2. EVD suspected Pre-notification (Positive Dispatch EMD Screen)
a. Dispatch notification of responding EMS ‘patient is High or Moderate Risk Illness with Travel’
b. On arrival, EMS must don PPE Kits: gown, N95, face protection, double glove, shoe protection
c. Perform EMS screening from 6 feet away from patient
i. If patient screens Low Risk Illness, doff to basic PPE level (gloves & masks), and contact
Resource and advise reasons for downgrading of risk level
ii. If patient screens Moderate Risk Illness with Travel:
1. Follow regional protocols
2. Maintain present PPE
3. Ask patient to apply mask, gown & gloves themselves
4. Contact Resource to advise of history/symptoms and ETA
iii. If patient screens High Risk Illness with Travel:
1. Contact Resource to advise of history/symptoms and ETA
2. GO TO STEP 3 BELOW
STEP 3. If patient is identified as High Risk Illness with Travel:
a. If PPE not already applied, remove EMS crew from environment and allow for SFD Haz-Mat to don
their full protection PPE (hooded coverall suits, double gloved, and NIOSH filtered masks) to
make entry to render direct patient care.
Note: if a tympanic membrane temperature is taken, take two temperatures, one from each ear and
take the highest figure. Red bag (meeting ASTM 1922 and ASTM1709 standards for 480 grams tear
resistance and 165 grams of impact resistance.) the ear probe caps & gauge and leave the red bag (meeting ASTM
1922 and ASTM1709 standards for 480 grams tear resistance and 165 grams of impact resistance.) in the patient
compartment of the transporting ambulance for disposal at SUNY.
b. SFD will use two HM personnel to render direct patient care. An R/M personnel will drive the
ambulance. Any person that has made patient contact should not enter the cab of the ambulance (Unit 137)
or other apparatus under any circumstances.
c. Ask the patient to apply the following (if their condition allows): surgical mask, gloves & gown
d. If the patient cannot ambulate, apply an impermeable (bariatric stretcher sheet) by wrapping the patient
‘burrito’ style with access to the head. Place a surgical mask on face.
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e. Patient care
i. Only bring disposable equipment to the patient (limit to absolutely necessary equipment only).
ii. Do not perform ANY invasive procedures unless absolutely necessary.
iii. No IV access unless for life-saving interventions.
iv. No IN or aerosolized medications.
v. IM Benzodiazepine should be used for delirium or agitation if necessary.
vi. NO PROCEDURES SHOULD BE PERFORMED IN A MOVING AMBULANCE.
EMS Field Care: Special Circumstances
a. If the patient screens Moderate or High Risk and is refusing transport, contact Resource and have R/M
Dispatch contact OCHD.
b. If the patient is found to be presumably deceased:
i. If PPE not already applied, remove crew from environment and preferably one EMS provider
don standard PPE, then make re-entry.
ii. Only one provider should make patient contact to assess and confirm death.
iii. No resuscitative effort should be performed.
iv. Maintain a 3-6 foot distance from the deceased at all times.
v. Contact Resource, OCHD, and law enforcement.
Note: if R/M responds to a PUI who is being monitored for 21 days and is NOT symptomatic, but injuries
themselves, EMS should treat this call as like any other and use minimum (basic) PPE: gloves and mask.
EMS providers should always take standard precautions when caring for patients, regardless of their presumed
diagnosis. This includes basic hand hygiene, respiratory hygiene, appropriate PPE (to block splashes or other
contact with infected materials) and safe injection practices.
Unit 137 - Special Transport Vehicle
Unit 137 is the designated transport vehicle to be used for suspected EVD patients and for regional inter-
facility EVD patient transports.
Unit 137’s patient compartment is completely stripped and gowned with 6 mil clear plastic secured with
duct tape to the walls, floor and back doors. This separation of the ambulance cab and patient compartment
will allow for two PPE EMS providers to be in the rear and for a non-PPE driver in the cab. **If SFD
HazMat is requested to don and provide patient care, R/M will provide Unit 137 and the R/M driver will
NOT be required to don PPE protection.
The patient stretcher mattress will be covered with a bariatric sheet (grey, impermeable), disposable
blankets with no available pillows. Disposable stretcher straps will be in place.
The patient compartment will have vomit bags, red bag (meeting ASTM 1922 and ASTM1709 standards
for 480 grams tear resistance and 165 grams of impact resistance.) s, B/P cuff, stethoscope, clavicide
(disinfectant) wipes and gloves.
On regional inter-facility transports, OCHD will provide R/M with a patient brief.
Appropriate medical supplies/equipment will be provided prior to transport for any anticipated patient
treatment.
The ambulance cab will have an EVD ‘Go Bag’ to include: N-95s, disposable sheets & blankets, red bag
(meeting ASTM 1922 and ASTM1709 standards for 480 grams tear resistance and 165 grams of impact
resistance.) s, gloves, duct tape, clavicide wipes, 2 personal protection kits, a large & an extra-large full
coverall suits for patient donning along with copies of R/M’s full coverall PPE don & doff procedures to be
surrendered to SUNY Upstate’s Suit Buddies to assist with R/M’s doffing of full coverall PPE at SUNY.
Transport
Separate the non-doffed driver from the patient compartment.
Prior to leaving the scene, the R/M driver will notify Resource when leaving and provide an ETA.
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Prior to arrival, SUNY will provide instructions to which hospital entrance will be used.
Primary entrance – Room 4730, behind Crouse Hospital
See attached SUNY Upstate Direct Admit Process for EVD Patients: EMS & 8m
R/M Support Manager will contact the SUNY Upstate’s Director of Emergency Management with an ETA
for the transporting R/M ambulance arrival time.
Patient and crew shall remain in the ambulance until advised by hospital staff.
1. No one other than the patient should be transported in the ambulance unless the patient is a minor.
2. Family or persons in direct contact with a suspected patient should be advised to remain at their current
location until notified otherwise.
At Hospital
Upon arrival at SUNY, contact Resource of arrival and remain in the ambulance until instructed by SUNY
staff to unload.
Keep stretcher on blue impermeable sheet on ground, follow thru double doors of Room 4730. This is as
far the stretcher will enter the hospital.
EMS personnel will not enter the hospital while still wearing PPE at any time
After patient transfer, keep the patient stretcher outside of the ambulance on the blue sheet and carefully
peel the 6 mil plastic wrap in the patient compartment off of walls, floors and back doors. Dispose of the
potentially contaminated plastic and any other materials used in the rear patient compartment as waste into
SUNY’s 55 gallon waste drums.
Any body fluid contamination on stretcher wheels will be disinfected with Clavicide wipes (kills non-
enveloped viruses) as a wet decontamination; goes on wet and allowed to dry for 10 minutes
R/M’s doffing of PPE will take place inside Room 4730. The doffing will be supervised by our Trained
Monitor to adhere to established procedures and a buddy system will be instituted to prevent self-
contamination or other exposure to EVD.
SUNY’s Suit Buddies will also assist EMS/Fire in their doffing procedures. See attached SUNY Upstate
Direct Admit Process for EVD Patients: EMS & 8m
An area to change into clean clothes will be available.
Decontamination
A R/M Supply Tech will be prepositioned as a trained person wearing appropriate PPE to perform decontamination.
This will allow the transfer EMS crew to doff, cleanse, and complete their documentation. The R/M Supply Tech
will conduct a wet decontamination of the patient compartment and gurney.
If no body fluids are present, then a gown, N95, face protection and double glove PPE should be worn.
Utilize the blue impermeable sheet on the ground at the back of the ambulance to collect all cleaning
materials.
R/M is using Clavicide wipes which meet the EPA label for non-enveloped virus to disinfect environmental
surfaces of vehicle and equipment used with suspected or confirmed Ebola virus infection.
A bulk wipe will be conducted on all surfaces of the patient compartment including the ceiling, gurney
antlers and the gurney.
If there was body fluids were spilled, then full protection PPE must be worn.
The Trained Monitor will provide careful attention to the vehicle decontamination process to ensure the
safety of the Supply Tech during the cleaning and decontamination process.
Double bag all disposable materials/equipment on blue sheet.
Double bag (red biohazard bags) all contaminated wipes/rags into properly labeled Red Biohazard Bags.
Clean and disinfect patient-care surfaces and equipment, and other areas that are likely to become
contaminated after each transport. Avoid contamination of reusable porous surfaces that are not designated
as single use.
Upstate Hospital EVD Guidance Downtown Campus
CONFIDENTIAL: Protected by NYS Ed. Law 6527 & Public Health Law 2805-m NO REDISCLOSURE OF THE ABOVE INFORMATION IS ALLOWED.
Place contaminated reusable patient care equipment (i.e. B/P cuff) in biohazard bags and label for cleaning
and disinfection. R/M has Supply Tech’s that are trained personnel who are familiar with our agency’s
protocol and the manufacturer’s instructions on how to clean and disinfect.
Discard any bodily secretions (i.e. vomit, urine) as directed by SUNY staff.
Leave vehicle to dry as normal.
Once cleaning and disinfecting is complete, doff PPE using the same procedures and with a Trained
Monitor.
Vehicle is to be returned to Station One and the outside is to be washed out in normal fashion using PPE.
R/M will work with SUNY and OCHD to obtain directions on managing the vehicle.
No individual should reenter the vehicle for any reason without prior medical clearance to do so.
Follow-up
1. EMS personnel with exposure to blood, bodily fluids, secretions or excretions from a patient with suspected
or confirmed Ebola should immediately:
i. Stop working and wash the affected skin surfaces with soap and water. Mucous membranes (i.e.
eyes) should be irrigated with a large amount of water or eyewash solution.
2. Notify R/M on-duty Shift Commander as soon as practical after exposure to a suspected Ebola patient.
3. R/M management will notify R/M’s Medical Director and OCHD for deciding the employees risk level,
guidance on care and the monitoring process.
4. R/M will make sure that each employee receives medical evaluation and follow-up care in accordance with
public health and CDC guidelines.
5. Any employee required being in isolation/quarantine and unable to work as a result of exposure to Ebola
will be placed on paid medical leave until cleared to return to duty.
R/M personnel who develop sudden onset of fever, intense weakness or muscle pains, vomiting, diarrhea, or any
signs of hemorrhage after exposure to a suspected or confirmed Ebola patient should:
Not report to work or immediately stop working and isolate themselves;
Notify R/M management, who should notify OCHD & NYS DOH;
From direction of OCHD/NYS DOH, post exposure management will begin; and
Comply with work exclusions until they are deemed no longer infectious to others.
Contacts:
SUNY Upstate - Phone
Chris Dunham, Emergency Management Director [email protected] cell 289-7354
Joe Tschoop, Emergency Management [email protected] cell 383-2581
Onondaga County Health Department (OCHD) – phone 435-3252
Dr. Quoc Nguyen, Medical Director [email protected]
Michelle Mignano, Deputy Commissioner [email protected] 435-3665
Indu Gupta, Public Health Commissioner [email protected]
NYS DOH Central New York Regional Office – Phone 477-8100
Amy O’Brien, Office of Health Emergency Preparedness [email protected] cell 480-5094
Dan Casler, Communicable Disease Program Director [email protected] 477-8177
Dr. David Brittain, Director Center NY Regional Office [email protected] 477-8522
Upstate Hospital EVD Guidance Downtown Campus
CONFIDENTIAL: Protected by NYS Ed. Law 6527 & Public Health Law 2805-m NO REDISCLOSURE OF THE ABOVE INFORMATION IS ALLOWED.
Upstate Hospital EVD Guidance Downtown Campus
CONFIDENTIAL: Protected by NYS Ed. Law 6527 & Public Health Law 2805-m NO REDISCLOSURE OF THE ABOVE INFORMATION IS ALLOWED.
Upstate Hospital EVD Guidance Downtown Campus
CONFIDENTIAL: Protected by NYS Ed. Law 6527 & Public Health Law 2805-m NO REDISCLOSURE OF THE ABOVE INFORMATION IS ALLOWED.
Appendix F : User guide CDESS for Employee Monitoring
Login to your HCS account: https://commerce.health.state.ny.us/public/hcs_login.html
1. Click on the ‘My Content’ button on the top right corner of the screen
2. Select ‘All Applications’ from the dropdown list
Upstate Hospital EVD Guidance Downtown Campus
CONFIDENTIAL: Protected by NYS Ed. Law 6527 & Public Health Law 2805-m NO REDISCLOSURE OF THE ABOVE INFORMATION IS ALLOWED.
3. Select the C tab at the top of the page
4. Select ‘Communicable Disease Electronic Surveillance ’ from the list of applications
5. You can also add this application to your favorites by selecting ‘Add/Remove’; this will make the
‘Communicable Disease Electronic Surveillance’ application show up on your HCS homepage.
Upstate Hospital EVD Guidance Downtown Campus
CONFIDENTIAL: Protected by NYS Ed. Law 6527 & Public Health Law 2805-m NO REDISCLOSURE OF THE ABOVE INFORMATION IS ALLOWED.
Upstate Hospital EVD Guidance Downtown Campus
CONFIDENTIAL: Protected by NYS Ed. Law 6527 & Public Health Law 2805-m NO REDISCLOSURE OF THE ABOVE INFORMATION IS ALLOWED.
Upstate Hospital EVD Guidance Downtown Campus
CONFIDENTIAL: Protected by NYS Ed. Law 6527 & Public Health Law 2805-m NO REDISCLOSURE OF THE ABOVE INFORMATION IS ALLOWED.
Upstate Hospital EVD Guidance Downtown Campus
CONFIDENTIAL: Protected by NYS Ed. Law 6527 & Public Health Law 2805-m NO REDISCLOSURE OF THE ABOVE INFORMATION IS ALLOWED.
Upstate Hospital EVD Guidance Downtown Campus
CONFIDENTIAL: Protected by NYS Ed. Law 6527 & Public Health Law 2805-m NO REDISCLOSURE OF THE ABOVE INFORMATION IS ALLOWED.
Upstate Hospital EVD Guidance Downtown Campus
CONFIDENTIAL: Protected by NYS Ed. Law 6527 & Public Health Law 2805-m NO REDISCLOSURE OF THE ABOVE INFORMATION IS ALLOWED.
Upstate Hospital EVD Guidance Downtown Campus
CONFIDENTIAL: Protected by NYS Ed. Law 6527 & Public Health Law 2805-m NO REDISCLOSURE OF THE ABOVE INFORMATION IS ALLOWED.
Upstate Hospital EVD Guidance Downtown Campus
CONFIDENTIAL: Protected by NYS Ed. Law 6527 & Public Health Law 2805-m NO REDISCLOSURE OF THE ABOVE INFORMATION IS ALLOWED.
Upstate Hospital EVD Guidance Downtown Campus
CONFIDENTIAL: Protected by NYS Ed. Law 6527 & Public Health Law 2805-m NO REDISCLOSURE OF THE ABOVE INFORMATION IS ALLOWED.
Upstate Hospital EVD Guidance Downtown Campus
CONFIDENTIAL: Protected by NYS Ed. Law 6527 & Public Health Law 2805-m NO REDISCLOSURE OF THE ABOVE INFORMATION IS ALLOWED.
Upstate Hospital EVD Guidance Downtown Campus
CONFIDENTIAL: Protected by NYS Ed. Law 6527 & Public Health Law 2805-m NO REDISCLOSURE OF THE ABOVE INFORMATION IS ALLOWED.
Upstate Hospital EVD Guidance Downtown Campus
CONFIDENTIAL: Protected by NYS Ed. Law 6527 & Public Health Law 2805-m NO REDISCLOSURE OF THE ABOVE INFORMATION IS ALLOWED.
Upstate Hospital EVD Guidance Downtown Campus
CONFIDENTIAL: Protected by NYS Ed. Law 6527 & Public Health Law 2805-m NO REDISCLOSURE OF THE ABOVE INFORMATION IS ALLOWED.
Upstate Hospital EVD Guidance Downtown Campus
CONFIDENTIAL: Protected by NYS Ed. Law 6527 & Public Health Law 2805-m NO REDISCLOSURE OF THE ABOVE INFORMATION IS ALLOWED.
Appendix F : 8m Video Monitoring User Guide
Upstate Hospital EVD Guidance Downtown Campus
CONFIDENTIAL: Protected by NYS Ed. Law 6527 & Public Health Law 2805-m NO REDISCLOSURE OF THE ABOVE INFORMATION IS ALLOWED.
Upstate Hospital EVD Guidance Downtown Campus
CONFIDENTIAL: Protected by NYS Ed. Law 6527 & Public Health Law 2805-m NO REDISCLOSURE OF THE ABOVE INFORMATION IS ALLOWED.
Upstate Hospital EVD Guidance Downtown Campus
CONFIDENTIAL: Protected by NYS Ed. Law 6527 & Public Health Law 2805-m NO REDISCLOSURE OF THE ABOVE INFORMATION IS ALLOWED.
Upstate Hospital EVD Guidance Downtown Campus
CONFIDENTIAL: Protected by NYS Ed. Law 6527 & Public Health Law 2805-m NO REDISCLOSURE OF THE ABOVE INFORMATION IS ALLOWED.