babesiosis investigation guideline• when interpreting ifa igg or total ig results, it is helpful...

Effective Date: 05/2018 Published Date:05/11/2018 Current version: 05/2018 Last Updated: 05/11/2018

Babesiosis Investigation Guideline

Contents

CASE DEFINITION ................................................................................................ 1

LABORATORY ANALYSIS ................................................................................... 2

INVESTIGATOR RESPONSIBILITIES .................................................................. 5 STANDARD CASE INVESTIGATION AND CONTROL METHODS ..................... 6

Case Investigation .................................................................................................. 6 Contact Investigation .............................................................................................. 7

Isolation, Work and Daycare Restrictions .................................................................. 7

Case Management .................................................................................................. 7

Contact Management (Informational purposes) ......................................................... 7

Environmental Measures ......................................................................................... 8

Education .............................................................................................................. 8

MANAGING SPECIAL SITUATIONS .................................................................... 9

A. Outbreak Investigation ..................................................................................... 9 DATA MANAGEMENT AND REPORTING TO THE KDHE ................................. 9

ADDITIONAL INFORMATION / REFERENCES ................................................ 10 Fact Sheet

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Effective Date: 05/2018 Published Date: 05/11/2018 Current version: 05/2018 Revision History,

Revision History:

Date Replaced Comments

05/2018 Released

Babesiosis Disease Management and Investigation Guidelines

Version 05/2018 Babesiosis, Page 1

CASE DEFINITION

Clinical Criteria (for the purposes of public health surveillance):

• Objective: one or more of the following: fever, anemia, or thrombocytopenia.

• Subjective: one or more of the following: chills, sweats, headache, myalgia, or arthralgia

Laboratory Criteria (for purposes of public health surveillance):

• Laboratory confirmed:

Identification of intraerythrocytic Babesia organisms by light microscopy in a Giemsa, Wright, or Wright-Giemsa–stained blood smear; OR

Detection of Babesia microti DNA in a whole blood specimen by polymerase chain reaction (PCR); OR

Detection of Babesia spp. genomic sequences in a whole blood specimen by nucleic acid amplification; OR

Isolation of Babesia organisms from a whole blood specimen by animal inoculation.

• Laboratory supportive:

Demonstration of a Babesia microti Indirect Fluorescent Antibody (IFA) total immunoglobulin (Ig) or IgG antibody titer of greater than or equal to (≥) 1:256 (or ≥1:64 in epidemiologically linked blood donors or recipients); OR

Demonstration of a Babesia microti Immunoblot IgG positive result; OR

Demonstration of a Babesia divergens IFA total Ig or IgG antibody titer of greater than or equal to (≥) 1:256; OR

Demonstration of a Babesia duncani IFA total Ig or IgG antibody titer of greater than or equal to (≥) 1:512.

Epidemiologic Linkage (for transfusion transmission):

For the purposes of surveillance, epidemiologic linkage between a transfusion recipient and a blood donor is demonstrated if all of the following criteria are met:

• In the transfusion recipient:

Received one or more red blood cell (RBC) or platelet transfusions within one year before the collection date of a specimen with laboratory evidence of Babesia infection; AND

At least one of these transfused blood components was donated by the donor described below; AND

Transfusion-associated infection is considered at least as plausible as tickborne transmission; AND

• In the blood donor:

Donated at least one of the RBC or platelet components that was transfused into the above recipient; AND

The plausibility that this blood component was the source of infection in the recipient is considered equal to or greater than that of blood from other involved donors. (More than one plausible donor may be linked to the same recipient.):

Kansas Department of Health and Environment Investigation Guidelines


Case Classification:

• Suspected:

A case that has confirmatory or supportive laboratory results, but insufficient clinical or epidemiologic information is available for case classification (e.g., only a laboratory report was provided).

• Probable:

A case that has supportive laboratory results and meets at least one of the objective clinical evidence criteria (subjective criteria alone are not sufficient); OR

A case that is in a blood donor or recipient epidemiologically linked to a confirmed or probable babesiosis case (as defined above) AND:

Has confirmatory laboratory evidence but does not meet any objective or subjective clinical evidence criteria; OR

Has supportive laboratory evidence and may or may not meet any subjective clinical evidence criteria but does not meet any objective clinical evidence criteria.

• Confirmed:

A case that has confirmatory laboratory results and meets at least one of the objective or subjective clinical evidence criteria, regardless of the mode of transmission (can include clinically manifest cases in transfusion recipients or blood donors).

LABORATORY ANALYSIS:

1) Detailed laboratory diagnosis information is available at www.cdc.gov/dpdx/babesiosis/dx.html

2) Blood smears: The Kansas Health and Environmental laboratory (KHEL) will facilitate parasite identification on stained thin blood smears working with CDC’s DPDx telediagnosis network and by referring specimens (including unstained blood smears and blood specimens) to CDC’s Division of Parasitic Diseases and Malaria.

• Multiple thick and thin smears may be necessary to identify a blood parasite and differentiate between Plasmodium and Babesia organisms.

• If a determination cannot be made from a smear, CDC may choose to perform species-specific PCR.

• Contact the KHEL at 785-296-3718 before sending any specimens.

3) Serological testing: Not available at KHEL, but is available through various commercial laboratories or can be arranged at special request though KHEL for testing at CDC. The provider must be sure to request testing for total Ig or IgG, as opposed to IgM alone.

• A positive Babesia IFA result for IgM is insufficient for diagnosis and case classification in the absence of a positive IFA result for IgG (or total Ig). If the IgM result is positive but the IgG result is negative, collect a follow-up blood specimen drawn at least one week after the first. If the IgG remains negative in the second specimen, the IgM result likely was a false positive.

https://www.cdc.gov/dpdx/babesiosis/dx.html



• When interpreting IFA IgG or total Ig results, it is helpful to consider factors that may influence the magnitude of Babesia titers (e.g., timing of specimen collection relative to exposure or illness onset, the patient’s immune status, the presence of clinically manifest versus asymptomatic infection).

• Serologic and molecular tests available for B. microti infection do not typically detect these other Babesia agents.

4) Blood-borne transmission of Babesia, laboratory testing: The epidemiologic linkage criteria for transfusion transmission described in the case definition (IgG antibody titer of ≥1:64 in epidemiologically linked blood donors or recipients) provides a low threshold for asymptomatic donor or recipient cases to be considered probable cases for surveillance purposes and are not intended to be regujaulatory criteria.

• Without an epidemiologic linkage for IgG antibody titers ≥1:64 but <1:256 or <1:512 (for B. duncani), the classification is “not a case” and no further investigation will occur.

• A potential epi link will result in a transfusion investigation that will entail laboratory testing for evidence of Babesia infection in recipients and donors as well as epidemiologic assessments of the plausibilities of blood- and tick-borne transmission.

EPIDEMIOLOGY

Babesia microti is the most frequently identified agent of human babesiosis in the United States; most reported tick-borne cases have been acquired in parts of northeastern and north-central regions. Sporadic U.S. cases caused by other Babesia agents include B. duncani (formerly the WA1 parasite) and related organisms (CA1-type parasites) in several western states as well as parasites characterized as "B. divergens like" (MO1 and others) in various states.

Blood-borne transmission of Babesia is not restricted by geographic region or season.

DISEASE OVERVIEW

A. Agent:

Hemoprotozoan parasite of genus Babesia, most commonly B. microti but also including B. duncani (formerly WA1), which was first described from Washington State, and B. divergens-like agents identified in the United States

B. Clinical Description:

Illness can be asymptomatic; symptoms include fever, chills, myalgia, arthralgia, enlarged spleen or liver, jaundice and hemolytic anemia, with more severe illness in the elderly, asplenia, and immunocompromised. Laboratory findings may include thrombocytopenia, proteinuria, hemoglobinuria, and elevated levels of liver enzymes, blood urea nitrogen, and creatinine.



C. Reservoirs:

Deer mice (Peromyscus leucopus) and other small mammals for B. microti in the United States; cattle for B. divergens in Europe; not definitively established for other zoonotic Babesia species.

D. Mode(s) of Transmission:

Transmission is usually through bites of infected Ixodes ticks; person-to-person transmission is by transfusion or, more rarely, transplacentally.

E. Incubation Period:

Variable, probably 1-8 weeks for tickborne transmission, and from weeks to months for bloodborne transmission. Symptoms may appear or recrudesce many months (even >1 year) after initial exposure, particularly in the context of immunosuppression.

F. Period of Communicability:

Communicable through transfusion, parasitemia may occur months to >1 year after infection; asymptomatic, undiagnosed parasitemia may be protracted.

G. Susceptibility and Resistance:

Susceptibility assumed to be universal. Persons who are asplenic, elderly, immunocompromised, or otherwise debilitated are at increased risk.

H. Treatment:

Most asymptomatic persons do not require treatment. Health care providers may consult CDC staff about whether to treat someone who has babesiosis, what type(s) of therapy to use, how to monitor the status of the infection, and how long to treat. Treatment decisions should be individualized, especially for patients who have (or are at risk for) severe or relapsing infection. (www.cdc.gov/parasites/babesiosis/health_professionals/index.html#tx)

NOTIFICATION TO PUBLIC HEALTH AUTHORITIES

Suspected cases of tickborne rickettsial disease (including anaplasmosis, ehrlichiosis, and spotted fever rickettsiosis) shall be reported 24 hours, except if the reporting period ends on a weekend or state-approved holiday, the report shall be made by 5:00 p.m. on the next business day after the 24-hour period:

1. Health care providers and hospitals: report to the local public health jurisdiction.

2. Local public health jurisdiction: report to KDHE-BEPHI (see below).

3. Laboratories: report to KDHE-BEPHI (see below).

Kansas Department of Health and Environment (KDHE) Bureau of Epidemiology and Public Health Informatics (BEPHI)

Phone: 1-877-427-7317 Fax: 1-877-427-7318

http://www.cdc.gov/parasites/babesiosis/health_professionals/index.html#tx



Further responsibilities of state and local health departments to the CDC:

As a nationally notifiable condition, confirmed and probable cases require a ROUTINE report to the Center of Disease Control and Prevention (CDC).

1. ROUTINE reporting requires KDHE-BEPHI to file an electronic report for within the next reporting cycle.

2. Local public health jurisdiction will report information requested as soon as possible, ensuring that the electronic form is completed within 7 days of receiving a notification of a report.

INVESTIGATOR RESPONSIBILITIES

1) Report all Babesiosis cases to the KDHE-BEPHI.

• Initiate the case investigation within 3 days of notification of a report.

• Complete the investigation within 14 days of the notification.

2) Contact medical provider to collect additional information and confirm diagnosis using current case definition. For all diagnosed cases:

• Collect all information requested in Step 1 of case investigation.

• Ensure that case/proxy is aware of the diagnosis.

3) Conduct a case investigation to determine the individual’s risks of exposure and potential geographical location of exposure.

• Identify exposures eight weeks prior to symptom onset or diagnosis (use earliest date), consider travel, tick bites, and exposure to tick habitats.

• Identify if the case-patient’s infection was transfusion associated.

• Use the CDC case form as a guide.

4) Conduct contact investigation to identify additional cases, as needed.

• If a potential blood transfusion or donation occurred within the last year, work with KDHE-BEPHI to test all blood donors or recipients associated with the case-patient.

5) Initiate any needed control and prevention measures.

• No isolation or restrictions apply.

• Case must defer donating blood for life.

• Educate those sharing a case’s exposure about signs and symptoms of babesiosis and encourage them to seek care if illness develops

6) Record data, collected during the investigation, in the KS EpiTrax system under the data’s associated [tab] in the case morbidity report (CMR).

7) As appropriate, use the disease fact sheet to notify the case, contacts and other individuals or groups.

https://www.cdc.gov/parasites/babesiosis/resources/50.153.pdf

http://www.kdheks.gov/epi/Fact_Sheets/Babesiosis_factsheet.doc



STANDARD CASE INVESTIGATION AND CONTROL METHODS

Case Investigation

1) Contact the medical provider who ordered testing of the case and obtain the following information. (Request medical records for hospitalized patients.)

• If the case-patient was identified through an IgG serological titer that is less than 1:256, identify if the case-patient received any blood products or organ donations the year before the specimen collection date.

Yes, blood products received or organ donation occurred: continue on with the investigation.

No blood products or organ donation received and titers <1:256: No further investigation required. Record findings and “Complete” and “Approve” the case as directed in Data Management.

• Did the medical provider diagnose a Babesiosis?

Yes: Record the diagnosis date [Clinical] and continue the investigation.

No, not diagnosed because of other findings: Record the alternative diagnosis and findings in the [Notes] of EpiTrax. Unless a potential transfusion association was identified, no further investigation should be required. “Complete” and “Approve” the case as directed in Data Management.

• Obtain information on any laboratory tests performed and fax results to KDHE at 1-877-427-7318, if not previously reported.

Blood Smear

IFA testing, IgM and IgG

Immunoblot or PCR

• Record onset date of first symptoms associated to this episode [Clinical]

• Symptoms: [Investigation – Symptoms]. Objective symptoms: fever, anemia and/ or thrombocytopenia

Subjective: headache, chills, sweats, myalgia, and arthralgia.

• Immunocompromised patient? [Investigation – Symptoms] Any underlying medical conditions: immune suppression or asplenia

(record date of splenectomy)

• Complications: [Investigation – Complications]

Any complications: acute respiratory distress, congestive heart failure, disseminated intravascular coagulation, myocardial infarction, renal failure

• Collect patient’s demographics (address, birth date, gender, race/ethnicity, primary language, and phone number(s)). [Demographic]

• Record treatment: [Clinical]

• Record hospitalizations: location and duration of stay [Clinical]

• Record outcomes: survived or date of death [Clinical]

• Record pregnancy status for women. [Clinical]

2) Establish if the patient’s illness is clinically compatible to Babesiosis based on lab criteria and clinical symptoms.



3) If a continued investigation is needed and the patient charts do not provide information on the following risk factors or travel, interview the case-patient to determine risk factors and transmission. [Investigation – Exposure]

• Identify exposures eight weeks prior to symptom onset or diagnosis (use earliest date.

• Travel out of county, state, or country: record dates and location

Especially make note of any travel to malaria endemic areas.

• Engage in outdoor activities, describe

• Spend time outdoors in or near wooded or brushy areas

• Any tick bites: geographic location where tick was acquired and when

• Occupational risks (e.g., laboratory worker, landscape worker, others)

Record patient’s occupation [Epidemiologic]

4) Examining the epidemiological information, record where the infection was most likely imported from. (Indigenous or out-of-county, state, or U.S.) [Epidemiologic].

5) Lost to follow-up: After several unsuccessful attempts to obtain needed information, fill out as much of the Babesiosis report as possible. Note why you could not obtain further information.

Contact Investigation

Not usually required, these diseases cannot be transmitted from person-to-person, but an individual living in the same household, travel companions, co-workers, and anyone else who might be exposed to ticks is potentially at risk. Exceptions: 1) Pregnant babesiosis cases require follow-up to report birth outcomes 2) Possible transfusion or organ transplant transmission; situation will be

evaluated by the KDHE-BEPHI to determine if a potential contact investigation is necessary.

Isolation, Work and Daycare Restrictions

No restrictions except permanent exclusion of a case-patient from blood donation.

Case Management

Ensure education has occurred on preventing further tick exposures and on refraining from blood donation.

Contact Management (Informational purposes)

1) Preventive treatment is not warranted. 2) Instruct those exposed to a tick to monitor themselves for symptoms.

Treatment is necessary only if symptoms develop. 3) Those who exhibit any signs or symptoms compatible with tick-borne illness

should be referred to their medical provider for evaluation.



Environmental Measures

Community-based integrated tick management strategies may reduce the incidence of tick-borne infections, but limiting exposure to ticks is the most effective method of prevention.

Education

As opportunities allow, the following general messages should be distributed:

• In tick-infested areas, the highest risk of bites is occurs from March-July.

• The use of protective clothing, including light-colored garments, long pants tucked into socks, long-sleeved shirts, hats, as well as tick repellents, may reduce risk.

• Outdoor activities in tick-infested areas present opportunities for exposure.

• Keep yards clear of excessive leaves, brush, and tall grasses. Walk in the center of trails to avoid contact with tall grasses and brush.

• When camping, sleep in screened tents.

• Hunters should be aware of tick infestations on mammals, especially deer, and check for tick attachments after handling carcasses.

• Keep pets free of ticks.

• Transmission requires a long attachment. Check for ticks at regular intervals while outdoors and after spending time outdoors in tick infested areas.

• Remove attached ticks intact, do not leave embedded head parts. Use gentle, direct traction with tweezers or hemostat. Other methods, such as application of a hot match or petroleum products to the tick, are less reliable. Do not crush ticks as this may result in direct inoculation of infectious agent.



MANAGING SPECIAL SITUATIONS

A. Outbreak Investigation:

• There are no formal outbreak definitions; however, the investigator may consider the possibility of an outbreak when there is an unusual clustering of cases in time and/or space.

• Notify KDHE immediately, 1-877-427-7317.

DATA MANAGEMENT AND REPORTING TO THE KDHE

A. Accept the case assigned to the LHD and record the date the LHD investigation was started on the [Administrative] tab.

B. Organize and collect data, using appropriate data collection tools including:

• The CDC Case Report Form can be used to collect information.

• Alternatively, investigators can collect and enter all required information directly into EpiTrax [Investigation], [Clinical], [Demographics], [Epidemiological] tabs.

• During outbreak investigations, refer to guidance from a KDHE epidemiologist for appropriate collection tools.

C. Report data collected during the course of the investigation via EpiTrax.

• Verify that all data requested on CDC Case Report Form has been recorded on an appropriate EpiTrax [tab], or that actions are completed for a case lost to follow-up as outlined below.

• Some data that cannot be reported on an EpiTrax [tab] may need to be recorded in [Notes] or scanned and attached to the record.

• Paper report forms do not need to be sent to KDHE after the information is recorded and/or attached in EpiTrax. The forms should be handled as directed by local administrative practices.

D. If a case is lost to follow-up, after the appropriate attempts to contact the case have been made:

• Indicate ‘lost to follow-up’ on the [Investigation] tab with the number of attempts to contact the case recorded.

• Record at least the information that was collected from the initial reporter.

• Record a reason for ‘lost to follow-up’ in [Notes].

E. Once the investigation is completed, the LHD investigator will record the date the investigation was completed on the [Administrative] tab and click the “Complete” button. This will trigger an alert to the LHD Administrator so they can review the case before sending to the state.

• The LHD Administrator will then “Approve” or “Reject” the CMR.

• Once a case is “Approved” by the LHD Administrator, BEPHI staff will review and close the case after ensuring it is complete and that the case is assigned to the correct event, based on the reported symptoms reported. (Review the EpiTrax User Guide, Case Routing for further guidance.)





http://www.kdheks.gov/epi/download/EpiTrax_User_Guide.pdf



ADDITIONAL INFORMATION / REFERENCES

A. Treatment / Differential Diagnosis: Red Book: 2015 Report of the Committee on Infectious Diseases. 30th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2015.

B. Epidemiology, Investigation and Control: Heymann. D., ed., Control of Communicable Diseases Manual (CCDM), 20th Edition. Washington, DC, American Public Health Association, 2015.

C. Case Definitions: CDC Division of Public Health Surveillance and Informatics, Available at: wwwn.cdc.gov/nndss/

D. Kansas Regulations/Statutes Related to Infectious Disease: www.kdheks.gov/epi/regulations.htm

E. Tickborne Diseases of the United States: A Reference Manual for Health Care Providers: www.cdc.gov/lyme/resources/TickborneDiseases.pdf

F. CDC Babesiosis web page: https://www.cdc.gov/parasites/babesiosis/

G. Additional Information (CDC): www.cdc.gov/ticks/index.html

http://wwwn.cdc.gov/nndss/

http://www.kdheks.gov/epi/regulations.htm

http://www.cdc.gov/lyme/resources/TickborneDiseases.pdf

https://www.cdc.gov/parasites/babesiosis/

http://www.cdc.gov/ticks/index.html

Version 1 (April 2013) 1

Transfusion-Associated Babesiosis Instructions for completing the investigation form

CDC’s Parasitic Diseases Branch developed the Transfusion-Associated Babesiosis form (and these instructions) to facilitate investigating and tracking potential transfusion-associated cases of babesiosis (e.g., by public health departments). Of note, CDC also has developed a generic Transfusion-Associated Infections form, which provides a useful framework for transfusion investigations (e.g., tables for tracking donors/donations). The babesiosis and generic forms are intended to serve as guides for investigating transfusion-associated babesiosis; they are not OMB (Office of Management and Budget)–approved report forms. As such, the forms are flexible and can be modified to suit the needs of the user and the case at hand. However, Babesia cases (regardless of mode of transmission) are notifiable to CDC by jurisdictions in which babesiosis is a reportable disease. Well-coordinated investigations among public health agencies, blood centers, transfusion services, clinicians, and laboratorians are strongly encouraged. CDC can be consulted regarding all aspects of diagnosing, treating, and investigating Babesia cases. The form is largely self-explanatory; however, some instructions are provided below, to assist in completing the form. Page numbers refer to those in the form. Throughout the form, approximate dates are acceptable (mm/yyyy), if precise dates are not available.

Transfusion-Associated Babesiosis: Instructions for completing the investigation form


Transfusion-Associated Babesiosis: Investigation Information (pages 1 & 2) Investigation #:

At the top of each page of the form, space is provided to record an identification number for the transfusion investigation. In addition, as noted below, space is provided on pages 3 and 5 for Case ID#’s for recipient(s) and donor(s), respectively.

Form completed by:

Provide contact information for the primary person who completed the form, even if multiple persons within your agency, as well as other agencies, collaborated in the investigation. Space for additional partners is provided on page 2.

Date completed:

Indicate the date this form was completed. Categorization:

The criteria provided on page 1 are intended to help assess the likelihood that a case of babesiosis was transfusion associated. These criteria and their associated categories (Definite, Probable, etc) are adapted from National Healthcare Safety Network (NHSN), a voluntary, internet-based surveillance system that integrates patient and healthcare personnel safety surveillance systems managed by CDC's Division of Healthcare Quality Promotion. NHSN also includes a component for hospitals to monitor adverse reactions and incidents associated with transfusions. In this context, NHSN developed generic criteria for classifying the likelihood that a case of infection was transfusion associated. We do not yet know whether and how often babesiosis transfusion cases will be reported via NHSN. All case criteria (including pathogen/disease-specific criteria) are dependent on laboratory expertise and epidemiologic/clinical judgment. In addition, the strength of evidence that a case was transfusion associated might change as the investigation proceeds and more information becomes available.

Contact information (page 2):

This page can be used to record additional contact information.



Transfusion-Associated Babesiosis: Recipient Information (pages 3 & 4) Indicate at the top of page 3 if the information in this section applies to the initial (index) recipient or to an additional (non-index) recipient, if any, linked to the same donor—either the same or a different donation. We recommend completing a separate copy of the Recipient Information section for each pertinent recipient, even though some questions might be more applicable to the index recipient. CDC Case Status:

If indicated, specify the case status (confirmed, probable, or suspect), using the CDC Case Classification Definition for national public health reporting: http://www.cdc.gov/osels/ph_surveillance/nndss/casedef/babesiosis_current.htm.

Case ID#:

This space is provided to record a case number. Demographics:

Include whatever basic demographic information is available. Indicate the recipient’s age at the time of the relevant transfusion(s); and specify if the unit is days, months, or years. For race, select all that apply.

Transfusion information

Summarize the number and type of cellular components that were transfused: On the appropriate blank line, specify the component(s) received in the year (12–month period) before babesiosis was diagnosed. Indicate if (and why) the period of interest is lengthened or shortened.

Date(s) of relevant transfusion(s): If this recipient was diagnosed with babesiosis and if a blood component(s) was ‘implicated’ in the investigation, specify the date(s) of transfusion(s). Use the Notes section (page 4) to provide more details.

Reason(s) for relevant transfusion(s): Select all that apply. Also see the question (page 4) regarding underlying medical conditions. Use the Notes section (page 4) to provide more details.

http://www.cdc.gov/osels/ph_surveillance/nndss/casedef/babesiosis_current.htm



Diagnostic testing Date of diagnosis:

The intent is to specify the date babesiosis was diagnosed, which might be later than the date(s) the pertinent specimen(s) was collected or initially examined (e.g., if babesiosis was diagnosed on retrospective review of specimens collected/tested earlier; see below). Approximate dates are acceptable. If the recipient (e.g., a non-index recipient) tests negative for evidence of Babesia infection, mark ‘Not applicable.’ If the recipient could not be located for testing, mark ‘Unknown.’

Were any pre-transfusion specimens tested for evidence of Babesia infection?

See the second criterion (page 1)—in essence: no evidence that the recipient was infected before the pertinent transfusion. Test type:

Specify type of test (e.g., blood smear, indirect fluorescent antibody [IFA] assay, polymerase chain reaction [PCR]).

Testing facility: Provide details about the laboratory that actually performed this testing (rather than a facility that collected the specimen but shipped it elsewhere). Indicate in the table or the Notes section (page 4) if multiple laboratories conducted testing (e.g., a commercial laboratory and CDC’s Parasitic Diseases Reference Diagnostic Laboratory).

Specimen: Specify type of specimen (e.g., whole blood or serum).

Date specimen collected: Specify date of collection.

Babesia species: If applicable to the test (e.g., B. microti-specific PCR), indicate the species.

Titer: If applicable to the test (e.g., B. microti IFA), indicate the titer.

Result: Specify the overall test result (positive, negative, indeterminate, or unknown). Use the Notes section (page 4) to provide more details (e.g., parasitemia level).

Were any post-transfusion specimens tested for evidence of Babesia infection?

Follow instructions for the preceding set of questions. Also see the first criterion (page 1)—i.e., laboratory evidence of Babesia infection in the recipient.

Did the recipient receive antimicrobial treatment for Babesia infection?

Select all that apply. Use the Notes section (page 4) to provide more details about antimicrobial or other therapy (e.g., exchange transfusion).



Clinical information Date of symptom onset:

Indicate the onset date of symptoms thought, in retrospect, to be attributable to babesiosis; this date might precede the date of diagnosis by a considerable amount of time. If asymptomatic, mark ‘Not applicable.’ Mark ‘Unknown,’ if this information is not available or is not even estimable (e.g., because the patient had comorbidities or altered mental status).

Clinical manifestations:

Specify presence (mark ‘Yes’) or absence (mark ‘No’) of the listed manifestations. Mark ‘Unknown,’ if the information is not available. Include other clinical manifestations on the extra line provided in this section or in the Notes section (page 4).

Underlying medical conditions:

Select all that apply.

Is the recipient asplenic? Functionally asplenic? Babesiosis can be more severe in persons who are asplenic. ‘Asplenic’ refers to surgical absence of the spleen. ‘Functionally asplenic’ applies to persons who have not undergone surgical splenectomy but have little or no splenic function (e.g., some patients with sickle cell disease have an autoinfarcted spleen). Approximate dates are acceptable for the date of splenectomy. However, if possible, obtain/provide perspective regarding the timing of and reason for splenectomy, particularly if the splenectomy was during the peritransfusion period (e.g., post-trauma transfusion and splenectomy) or thereafter; splenectomy can trigger activation of latent Babesia infection.

History of diagnosis or treatment of other tickborne diseases:

A history of other tickborne diseases could be indicative of risk factors for tick exposure (see questions below) but would not necessarily exclude the possibility that Babesia parasites were transmitted via transfusion. Use the Notes section (page 4) to provide more details (e.g., year of diagnosis).

Risk factors (in addition to transfusion)

Is there a possibility that this case was tick transmitted? Indicate if the recipient (if infected) might have become infected via a tick bite. Consider potential exposures in state/county of residence or while traveling. Also see questions below. Attempt to assess the relative possibility and plausibility of tickborne vs. transfusion-associated infection. Use the Notes section (page 4) to provide more details/perspective.

Is there a possibility that this case was congenital?

If the case-patient is an infant and if the mode of transmission could have been congenital, answer additional questions:

Was the patient’s mother tested for evidence of Babesia infection? What were the results of the testing?



The following questions deal with activities and potential exposures during a particular period. (In the Notes section, indicate if and why the period of interest is adjusted—e.g., lengthened.)

In the year (12-month period) before the relevant blood transfusion, did the recipient…:

Live in/travel to the Northeast or upper Midwest? If yes, indicate (by selecting all that apply) where, how long (<1 week, 1–4 weeks, 5 or more weeks), and whether any part of that time was during June–September, the period during which ticks are most likely to be questing for a blood meal. However, the seasonality may vary by year and place. Use the Notes section (page 4) to provide more details.

Engage in outdoor activities? If yes, select all that apply from the list of activities, and specify the state(s) where the activities occurred. Known risk areas for tickborne transmission of B. microti include parts of the Northeast and upper Midwest. However, outdoor activities in any location also should be specified. The timeframe of June–September is intended to capture outdoor exposures when ticks are most likely to be questing for a blood meal. However, the seasonality may vary by year and place. Use the Notes section (page 4) to provide more details.

Spend time in or near wooded or brushy areas? The intent is to know whether the recipient spent time in areas where ticks might have been present. Of note, persons may have spent time in or near wooded or brushy areas without engaging in outdoor activities. (See previous question.)

Notice any tick bites? Indicate when the recipient noticed the tick bite and where (county/state) the recipient was when it occurred. Of note, tick bites can easily be overlooked.

Notes:

This section can be used to record additional test results and other information about this recipient—e.g., factors that affect the possibility and plausibility of various routes of transmission.



Transfusion-Associated Babesiosis: Donor Information (pages 5 & 6) We recommend completing the Donor Information section for each pertinent donor. (Also see the generic Transfusion-Transmitted Infections form.) Throughout the form, approximate dates are acceptable (mm/yyyy). CDC Case Status:

If indicated, specify the case status (confirmed, probable, or suspect), using the CDC Case Classification Definition for national public health reporting: http://www.cdc.gov/osels/ph_surveillance/nndss/casedef/babesiosis_current.htm.

Case ID#:

This space is provided to record a case number. Demographics:

Include whatever basic demographic information is available. Indicate the donor’s age at the time of the index donation (donation associated with the index recipient; see below). For race, select all that apply.

Donation information

Date(s) of relevant donation(s): Specify the date(s) of index and other relevant donation(s), if any. Use the Notes section (page 6) to provide more details.

For the index donation:

Was a retained segment or cocomponent tested for evidence of Babesia infection? Of note, segments are also called pigtails or retention tubes. What were the results of the testing?

Provide more details in the table below (donor diagnostic testing).

Were there additional recipients of cellular components from the index donation? We recommend completing the Recipient Information section for each recipient, regardless of whether the patient tested positive.

For other donation(s):

Were there recipients of cellular components? Consider previous and subsequent donations. We recommend completing the Recipient Information section for each recipient, regardless of whether the patient tested positive.

http://www.cdc.gov/osels/ph_surveillance/nndss/casedef/babesiosis_current.htm



Donor diagnostic testing: See the third criterion (page 1)—i.e., laboratory evidence of the same Babesia sp. in the donor.

Test type: Specify type of test (e.g., blood smear, indirect fluorescent antibody [IFA] assay, polymerase chain reaction [PCR]).

Testing facility: Provide details about the laboratory that actually performed this testing (rather than a facility that collected the specimen but shipped it elsewhere). Indicate in the table or the Notes section (page 6) if multiple laboratories conducted testing (e.g., a commercial laboratory and CDC’s Parasitic Diseases Reference Diagnostic Laboratory).

Specimen: Specify type of specimen (e.g., whole blood or serum).

Date specimen collected: Specify date of collection. For example, if a segment (pigtail) from the original donation(s) was available for testing (see above), the date of collection would be the date of donation. Use the Notes section (page 6) to provide more details.

Babesia species: If applicable to the test (e.g., B. microti-specific PCR), indicate the species.

Titer: If applicable to the test (e.g., B. microti IFA), indicate the titer.

Result: Specify overall test result (positive, negative, indeterminate, or unknown).

Did the donor receive antimicrobial treatment for Babesia infection?

Select all medications that apply, if the donor was treated. Clinical information

Date of diagnosis: For example, if a segment from the original donation tested positive, the date of diagnosis would be the date of testing. (See donor diagnostic testing above.)

Date of symptom onset:

Indicate the onset date (or approximate timing) of potentially relevant symptoms, if any, that occurred either before or after the relevant donation(s); see next 2 questions. If the donor does not recall any pre- or post-donation symptoms, mark ‘Not applicable.’ Mark ‘Unknown,’ if the information is not available.

Symptoms (if any) before relevant donation(s):

Indicate potentially relevant symptoms (e.g., fever, headache, chills, sweats, myalgia, arthralgia) that were noted before the blood donation. Use the Notes section (page 6) for more details.

Symptoms (if any) after relevant donation(s):

See instructions for previous question.

Clinical manifestations (if any): If applicable, indicate other potentially relevant clinical manifestations, such as anemia or thrombocytopenia.



History of diagnosis or treatment of other tickborne diseases: A history of other tickborne diseases could be indicative of risk factors for tick exposure. (See questions below.)

Risk factors The following questions deal with activities and potential exposures during a particular period. (In the Notes section, indicate if and why the period of interest is adjusted—e.g., lengthened.)

In the year (12-month period) before the relevant blood donation(s), did the donor…:

Live in/travel to the Northeast or upper Midwest? If yes, indicate (by selecting all that apply) where, how long (<1 week, 1–4 weeks, 5 or more weeks), and whether any part of that time was during June–September, the period during which ticks are most likely to be questing for a blood meal. However, the seasonality may vary by year and place. Use the Notes section (page 6) to provide more details.

Engage in outdoor activities? If yes, select all that apply from the list of activities, and specify the state(s) where the activities occurred. Known risk areas for tickborne transmission of B. microti include parts of the Northeast and upper Midwest. However, outdoor activities in any location also should be specified. The timeframe of June–September is intended to capture outdoor exposures when ticks are most likely to be questing for a blood meal. However, the seasonality may vary by year and place. Use the Notes section (page 6) to provide more details.

Spend time in or near wooded or brushy areas? The intent is to know whether the donor spent time in areas where ticks might have been present. Of note, persons may have spent time in or near wooded or brushy areas without engaging in outdoor activities. (See previous question.)

Notice any tick bites? Indicate when the donor noticed the tick bite and where (county/state) the recipient was when it occurred. Of note, tick bites can easily be overlooked.

Notes:

This section can be used to record additional test results and other information about this donor—e.g., factors that affect the possibility and plausibility that the donor was infected at the time of the pertinent donation(s).


Transfusion-Associated Infections Instructions for completing the generic investigation form

CDC developed the generic Transfusion-Associated Infections form (and these instructions) to facilitate investigating and tracking potential transfusion-associated cases of infection (e.g., by public health departments). The form provides a broadly applicable framework for transfusion investigations; for example, it includes tables for tracking and recording information about blood donors, donations, transfusions, and recipients. The generic investigation form is not an OMB (Office of Management and Budget)–approved report form. As such, the form can be modified to suit the needs of the user and the particulars of the case at hand, and it can be used in combination with other applicable/available forms. For example, selected tables on the generic form could be used to supplement a disease-specific module (e.g., CDC’s Transfusion-Associated Babesiosis form). Well-coordinated investigations among public health agencies, blood centers, transfusion services, clinicians, and laboratorians are strongly encouraged. CDC can be consulted regarding all aspects of diagnosing, treating, and investigating cases. The form is largely self-explanatory; however, some instructions are provided below to assist in completing the form. In the instructions, all page numbers refer to those in the form. Depending on the trigger for the investigation, begin either with the Recipient Investigation section (pages 1 and 2) or the Donor Investigation section (pages 3 and 4). If a donor(s) is ‘implicated’ (e.g., by laboratory and epidemiologic criteria), consider/investigate the possibility that other recipients linked to the same donor (either the same or a different donation) became infected. Throughout the form, approximate dates are acceptable (mm/yyyy), if precise dates are not available.

Transfusion-Associated Infections: Instructions for completing the generic investigation form


Transfusion-Associated Infections: Recipient Investigation (pages 1 & 2) Date completed:

Indicate the date this section of the form (Recipient Investigation) was completed. Investigation #:

At the top of each page of the form, space is provided to record an identification number for the transfusion investigation. In addition, as noted below, space is provided on pages 1 and 3 for Case ID#’s and other identifiers for recipient(s) and donor(s), respectively.

Categorization:

The categories (Definite, Probable, etc.) provided on page 1 are intended to help assess the likelihood that a case of infection was transfusion associated (http://www.cdc.gov/nhsn/PDFs/Biovigilance/BV-HV-protocol-current.pdf, Page 18 of 27, January 2013). These categories are adapted from National Healthcare Safety Network (NHSN), a voluntary, internet-based surveillance system that integrates patient and healthcare personnel safety surveillance systems managed by CDC's Division of Healthcare Quality Promotion. NHSN also includes a component for hospitals to monitor adverse reactions and incidents associated with transfusions. In this context, NHSN developed generic criteria for classifying the likelihood that a case of infection was transfusion associated. All case criteria (including pathogen/disease-specific criteria) are dependent on laboratory expertise and epidemiologic/clinical judgment. In addition, the strength of evidence that a case was transfusion associated might change as the investigation proceeds and more information becomes available.

Pathogen:

Specify the pathogen (or suspected pathogen, if not yet confirmed). If known, provide both the genus and species (e.g., Babesia microti). Of note, consider using a disease-specific module, if available (e.g., CDC’s Transfusion-Associated Babesiosis form).

Form completed by:

Provide contact information for the primary person who completed this form/section, even if multiple persons within your agency, as well as other agencies, collaborated in the investigation. If applicable, in the donor section (page 3), a different person can be specified.

Date reported to the investigator/agency:

Provide the date (or approximate time) this recipient/patient first came to the attention of the investigator/agency. If applicable, in the donor section (page 3), a different date can be specified.

Reported by:

Provide contact information for the relevant person/agency (e.g., physician or blood collection agency). If applicable, in the donor section (page 3), a different person/agency can be specified.

http://www.cdc.gov/nhsn/PDFs/Biovigilance/BV-HV-protocol-current.pdf



Indicate if the information in this section applies to the initial (index) recipient or to an additional (non-index) recipient, if any, linked to the same donor—either the same or different donations. We recommend completing a separate copy of the Recipient Investigation section for each pertinent recipient, even though some questions might be more applicable to the index recipient. Case ID#:

This space is provided to record a case number or another unique ID. Demographics:

To facilitate tracking and differentiating among recipients, provide whatever basic demographic information is available, in accordance with privacy protection laws. Record name (or another unique identifier), address, contact information, and date of birth (or mm/yyyy). Indicate the recipient’s age at the time of the relevant transfusion(s); and specify if the age is provided in days, months, or years. For race, select all that apply.

Clinical information

Date of symptom onset: Indicate the onset date of clinical manifestations thought, in retrospect, to be attributable to the infection; this date might precede the date of diagnosis by a considerable amount of time. If asymptomatic, mark ‘Not applicable.’ Mark ‘Unknown,’ if this information is not available or is not even estimable (e.g., because the patient had comorbidities or altered mental status).

Clinical manifestations, if any:

See previous question. If applicable, specify the potentially relevant clinical manifestations. Use the Notes section (page 2) to provide more details.

Diagnostic testing When available, a disease-specific module (e.g., CDC’s Transfusion-Associated Babesiosis form), may have a similar table with greater detail for diagnostic testing. If so, the table in the disease-specific module can be used. Date of diagnosis

If applicable, provide the date the recipient’s case was explicitly diagnosed. For non-index recipients, there may not be a date of diagnosis.

Were any pre-transfusion specimens tested for evidence of infection?

Specify if the recipient was tested for evidence of infection before the transfusion or if a pre-transfusion specimen was still available and has since been tested.

If yes, what was overall result of the testing?

Indicate whether evidence of pre-transfusion infection was detected, by specifying the overall result of the testing (positive, negative, indeterminate, or unknown); use the space on the next line of the form to provide more details (see ‘result’ below).

Test type(s):




Result(s) (e.g., titer):

Provide available details that are applicable to the test (e.g., titer, species, parasitemia level). (See above regarding ‘overall result.’)

Testing facility: Provide details about the laboratory that actually performed this testing (rather than a facility that collected the specimen but shipped it elsewhere). Indicate in the table or the Notes section (page 2) if multiple laboratories conducted testing (e.g., a commercial laboratory and CDC).

Were any post-transfusion specimens tested for evidence of infection?

Date of collection:

Specify date of collection, which might differ from the date(s) of testing. Use the Notes section (page 2) to provide more details.

Date of testing:

Specify date the testing was performed. Indicate in the table or the Notes section (page 2) if the testing was performed on multiple days (e.g., initial vs. retrospective testing). If pertinent, also indicate the date the results were reported (i.e., became available).

Specimen:

Specify type of specimen (e.g., whole blood or serum). Test type:


Result:

Specify overall result (positive, negative, indeterminate, or unknown). If available, provide more details (e.g., titer or species) in the table or the Notes section (page 2).

Testing facility:

Provide details about the laboratory that actually performed this testing (rather than a facility that collected the specimen but shipped it elsewhere). Indicate in the table or the Notes section (page 2) if multiple laboratories conducted testing (e.g., a commercial laboratory and CDC).

Did the patient receive treatment for this infection?

If applicable, use the Notes section (page 2) to provide more details about antimicrobial or other therapy, as well as the clinical context.

Risk factors

Did the recipient have possible routes of exposure other than transfusion? If yes, describe potential exposures, including where and when they may have occurred. Use the Notes section (page 2) to provide more details/perspective, to help assess the relative possibility and plausibility of various routes of transmission.



Current status: Specify the patient’s status. If the patient died, provide the date of death; indicate whether an autopsy was performed; and, even if it was not, indicate if the infection might have contributed to or caused the death.

Transfusion history

Some recipients might have been multiply transfused over a short or extended period; a large number of donors may need to be investigated. The timeframe to consider and the relevant blood products depend in part on the pathogen and host factors.

Reason(s) for transfusion(s):

Specify the reason(s) the recipient was transfused. Use the Notes section (page 2) to provide more details/perspective (e.g., the proximal and underlying reasons/comorbidities).

For each potentially relevant transfusion, specify in the table the type of product (e.g., red blood cells or platelets), the date of transfusion, the transfusion facility (where the transfusion occurred), the blood supplier, and the Blood Product Unit Number (the identifier used to track the product/component). If needed, use Recipient Investigation: Additional Sheet.

Every blood donation has a unique identifying number (whole blood number, or WBN). A blood donation may be separated into multiple blood products (e.g., red blood cells or platelets), each of which has a different Blood Product Unit Number. Depending on the pathogen, only particular types of blood products/components might be relevant or particular types might pose a higher risk than others.

Donor tracking

In the first column of this table, record each of the Blood Product Unit Numbers listed in the last column of the previous table. Then track each unit number: Specify the blood bank/center, the date of donation, the status of the pertinent donor (whether located/tested), details about donor testing (test type and results; see instructions above), and conclusions regarding that donor (donor ‘implicated?’).

For each potentially relevant donor, complete the Donor Investigation section (pages 3 and 4), to record more information about the donor (e.g., demographic and additional laboratory data) and to facilitate identifying/tracking other recipients linked to the donor—either the same or different donations.

Facility(ies) where ‘implicated’ transfusion(s) occurred:

If applicable, provide additional details about the transfusion facility(ies), including for a point of contact. Additional space is available in the Notes section that follows.

Notes:

This section can be used to record additional test results and other information about this recipient—e.g., factors that affect the possibility and plausibility of various routes of transmission.



Transfusion-Associated Infections: Donor Investigation (pages 3 & 4) Date completed:

Indicate the date this section of the form (Donor Investigation) was completed. If applicable, a different date can be specified in the header in the recipient section (pages 1 & 2).

Investigation #:

At the top of each page of the form, space is provided to record an identification number for the transfusion investigation. In addition, space is provided on pages 1 and 3 for Case ID#’s and other identifiers for recipient(s) and donor(s), respectively.

Pathogen:

Specify the pathogen (or suspected pathogen, if not yet confirmed). If known, provide both the genus and species (e.g., Babesia microti). Of note, consider using a disease-specific module, if available (e.g., CDC’s Transfusion-Associated Babesiosis form).

Form completed by:

Provide contact information for the primary person who completed this form/section, even if multiple persons within your agency, as well as other agencies, collaborated in the investigation. If applicable, in the recipient section (page 1), a different person can be specified.

Date reported to the investigator/agency:

Provide the date (or approximate time) this donor first came to the attention of the investigator/agency. If applicable, in the recipient section (page 1), a different date can be specified.

Reported by:

Provide contact information for the relevant person/agency (e.g., physician or blood collection agency). If applicable, in the recipient section (page 1), a different person/agency can be specified.

ID#:

This space is provided to record a case number or another unique ID. Demographics:

To facilitate tracking and differentiating among donors, provide whatever basic demographic information is available, in accordance with privacy protection laws. Record name (or another unique identifier), address, contact information, and date of birth (or mm/yyyy). Indicate the donor’s age at the time of the index donation (donation associated with the index recipient). For race, select all that apply.

Clinical information

Date of symptom onset: Indicate the onset date (or approximate timing) of potentially relevant clinical manifestations, if any, that occurred either before or after the relevant donation(s). If asymptomatic, mark ‘Not applicable.’ Mark ‘Unknown,’ if this information is not available.



Clinical manifestations, if any: See previous question. If applicable, specify the potentially relevant clinical manifestations. Use the Notes section (page 4) to provide more details.

Diagnostic testing

Date of collection:

For example, if a segment (pigtail or retention tube) or cocomponent was available for testing, the date of collection would be the date of donation. Use the Notes section (page 4) to provide more details.

Date of testing:

Specify the date the testing was performed, which might be long after a specimen (e.g., a segment) was collected. If pertinent, also indicate the date the results were reported (i.e., became available).

Specimen:

Specify type of specimen (e.g., whole blood or serum). Segment/Cocomponent:

Indicate if this specimen was part of a retained segment or cocomponent from the pertinent donation or from a previous or subsequent donation (vs. a specimen collected as part of an investigation). If yes, provide additional details in the space provided below the table.

Test type:


Result:

Specify overall result (positive, negative, indeterminate, or unknown). If available, provide more details (e.g., titer or species) in the table or the Notes section (page 4).

Testing facility:

Provide details about the laboratory that actually performed this testing (rather than a facility that collected the specimen but shipped it elsewhere). Indicate in the table or the Notes section (page 4) if multiple laboratories conducted testing (e.g., a commercial laboratory and CDC).

Testing details

See above. Use this space to provide additional details about the testing, including types of segments/components and the test results.

Risk factors

Did the donor have risk factors for infection with the pathogen? If yes, describe potential exposures, including where and when they may have occurred. Use the Notes section (page 4) to provide more details.



Donation history The timeframe to consider and the relevant blood products depend in part on the pathogen and host factors.

Date of donation:

Indicate when it occurred. Donation facility:

Indicate where it was collected. Blood Product Unit Number:

Specify the identifier used to track the product/component. Type of product:

Specify the pertinent product/component (e.g., red blood cells or platelets). Transfused?

Indicate whether it was transfused. Complete the table that follows for each transfused product. Recipient tracking

For each transfused product (see last column in previous table), record the Blood Product Unit Number and the type of product (from the 3rd and 4th columns in the previous table). Then specify the date of transfusion, the transfusion facility (where the transfusion occurred), and a unique recipient identifier (see page 1 of the form for various options). If needed, additional recipients can be tracked on the Donor Investigation: Additional Sheet.

Diagnostic testing for recipient(s)

In the first column of this table, record each of the recipient identifiers listed in the last column of the previous table. Then track/record details about recipient testing: Specify the date of collection, the date of testing, the specimen (e.g., whole blood or serum), test type (e.g., blood smear, indirect fluorescent antibody [IFA] assay, polymerase chain reaction [PCR]), the result (e.g., overall result [positive, negative, indeterminate] and additional details [titer or species]), and the testing facility (i.e., the laboratory that actually performed this testing rather than a facility that collected the specimen but shipped it elsewhere). Complete a copy of the Recipient Investigation section for each pertinent recipient.

Notes:

This section can be used to record additional test results and other information about this donor—e.g., factors that affect the possibility and plausibility that the donor was infected at the time of the pertinent donation(s).

Date completed: ___________ Investigation #: ___________

CDC 50.154 (E), December 2012, CDC Adobe Acrobat 10.1, S508 Electronic Version, December 2012 CDC developed this generic investigation form (also see instructions for the form) to facilitate investigating and tracking potential transfusion-associated cases. The generic form (version 1; 5/18/2012) provides a broadly applicable framework and can be used in combination with a disease-specific module, if applicable/available. The intent is for the forms and instructions to be part of a larger toolkit. Page 1

Transfusion-Associated Infections: Recipient Investigation Categorization: Definite Probable Possible Ruled Out Pending Unknown Pathogen:

Form completed by: Name: Phone:

Affiliation: Email:

Date reported to the investigator/agency (mm/dd/yyyy): ___________ Reported by: Name, Affiliation: Address: City: County: State: Zip: Phone: Email: Initial (Index) Recipient Additional (Non-index) Recipient Case ID# Demographics Last name: First name: MI: Address: City: County: State: Zip:

Phone: Email:

Date of birth (mm/dd/yyyy) : ___________ Age:_____ days months years Sex: Male Race American Indian or Alaska Native Ethnicity: Hispanic/Latino

Female (select all Asian or Pacific Islander Not Hispanic/Latino Unknown that apply): Black/African American Unknown

White Other, specify: _______________ Unknown

Clinical information (approximate dates [mm/yyyy] are acceptable) Date of symptom onset (mm/dd/yyyy) : ___________ Not applicable Unknown Clinical manifestations, if any (specify): Diagnostic testing (approximate dates [mm/yyyy] are acceptable) Date of diagnosis: ___________ Not applicable Unknown Were any pre-transfusion specimens tested for evidence of infection? Yes No Unknown If yes, what was the overall result of the testing? Positive Negative Indeterminate Unknown Test type(s): Result(s) (e.g., titer): Testing facility (name, city, state):

Were any post-transfusion specimens tested for evidence of infection? Yes No Unknown If more space is needed, use Recipient Investigation: Additional Sheet (page 5).

Date of collection

Date of testing Specimen Test type Overall result

(e.g., positive) Testing facility (name, city, state)

Did the patient receive treatment for this infection? Yes No Not applicable Unknown Specify:



Transfusion-Associated Infections: Recipient Investigation (cont.)

Risk factors Did the recipient have possible routes of exposure other than transfusion (e.g., vectorborne or congenital)? Yes No Not applicable Unknown If yes, specify:

Current status: Home; never hospitalized due to (or with) this infection (as of ___________) Home; previously hospitalized due to this infection; specify hospital: Currently hospitalized due to this infection; specify hospital:

Long-term hospitalization/never left hospital (e.g., neonate) Nursing home/Rehabilitation facility; specify: Died (mm/dd/yyyy) : ___________; Autopsy? Yes No Unknown Was death related to this infection? Yes No Unknown Unknown Transfusion history

The timeframe to consider and the relevant blood products depend in part on pathogen and host factors. If more space is needed, use Recipient Investigation: Additional Sheet (page 5).

Reason(s) for transfusion(s): Type of product Date of

transfusion Transfusion facility

(name, city, state) Blood supplier (name, city, state)

Blood Product Unit Number Donor tracking Identify donors for the pertinent blood products listed in the table above.

Blood Product Unit

Number Blood bank/center

(name, city, state) Date of

donation Donor

located? Test type (for donor)

Overall result

(for donor) Donor

implicated?

Note: More than one donor may be implicated. Complete the Donor Investigation section for each pertinent donor; identify/track corecipients, as well as recipients of previous or subsequent donations.

Facility(ies) where implicated transfusion(s) occurred: Name and address: City: State: Zip: Contact person: Phone:

Notes:



Transfusion-Associated Infections: Donor Investigation Pathogen:


Affiliation: Email:

Date reported to the investigator/agency (mm/dd/yyyy) : ___________ Reported by: Name, Affiliation: Address: City: County: State: Zip: Phone: Email:

ID# Demographics Last name: First name: MI: Address: City: County: State: Zip: Phone: Email:

Date of birth (mm/dd/yyyy) : ___________ Age: years Sex: Male Race American Indian or Alaska Native Ethnicity: Hispanic/Latino

Female (select all Asian or Pacific Islander Not Hispanic/Latino Unknown that apply): Black/African American Unknown

White Other, specify:_______________ Unknown

Clinical information (approximate dates [mm/yyyy] are acceptable) Date of symptom onset (mm/dd/yyyy) : ___________ Not applicable Unknown Clinical manifestations, if any (specify):

Diagnostic testing (approximate dates [mm/yyyy] are acceptable) If more space is needed, use Donor Investigation: Additional Sheet (page 6).

Date of collection

Date of testing Specimen Segment/

Cocomponent Test type Overall result


Testing details

Risk factors Did the donor have risk factors for infection with the pathogen? Yes No Unknown If yes, specify:



Transfusion-Associated Infections: Donor Investigation (cont.) Donation history The timeframe to consider and the relevant blood products depend in part on pathogen and host factors. If more space is needed, use Donor Investigation: Additional Sheet (page 6).

Date of donation

Donation facility (name, city, state)

Blood Product Unit Number

Type of product Transfused?

Recipient tracking

Track all relevant donations listed in the donation history. Blood Product

Unit Number Type of product Date of transfusion Transfusion facility

(name, city, state) Recipient identifier

Diagnostic testing for recipient(s)

If more space is needed, use Donor Investigation: Additional Sheet (page 6).

Recipient identifier

Date of collection

Date of testing

(for recipient) Specimen (for recipient)

Test type (for recipient)

Overall result

(for recipient) Testing facility (name, city, state)

Notes:



Transfusion-Associated Infections: Recipient Investigation Additional Sheet Initial (Index) Recipient Additional (Non-index) Recipient Case ID# Diagnostic testing

Date of collection

Date of testing Specimen Test type Overall result


Transfusion history

Type of product

Date of transfusion

Transfusion facility (name, city, state)

Blood supplier (name, city, state)


Donor tracking


Blood bank/center (name, city, state)

Date of donation

Donor located?

Test type (for donor)

Overall result

(for donor) Donor

implicated?



Transfusion-Associated Infections: Donor Investigation Additional Sheet ID# Diagnostic testing

Date of collection

Date of testing Specimen Segment/

Cocomponent Test type Overall result (e.g., positive)

Testing facility (name, city, state) Donation history

Date of donation

Donation facility (name, city, state)


Type of product Transfused?

Recipient tracking Blood Product

Unit Number Type of product Date of transfusion Transfusion facility (name, city, state)

Recipient identifier

Diagnostic testing for recipient(s) Recipient

identifier Date of

collection Date of testing

(for recipient) Specimen (for recipient)

Test type (for recipient)

Overall result (for recipient)

Testing facility (name, city, state)

Investigation #: ________________

CDC’s Parasitic Diseases Branch developed this investigation form (also see instructions for the form) to facilitate investigating and tracking potential transfusion-associated cases of babesiosis. This form (version 1; 11/5/2011)—and the complementary generic investigation form—likely will be revised periodically after pilot testing. The intent is for the forms and instructions to be part of a larger toolkit. Page 1

Transfusion-Associated Babesiosis: Investigation Information


Affiliation: Email:

Date completed: __________

Categorization Definite Probable Possible Ruled Out Pending as of (__________) (see Criteria below): Unknown

Classification Criteria * 1) Laboratory evidence of Babesia sp. in the recipient Yes No Unknown

2) Evidence that the recipient was not infected prior to transfusion Yes No Unknown 3) Laboratory evidence of infection with the same Babesia sp. in the

donor by testing of the donor, the recipient unit (or retained Yes No Unknown segment), or cocomponent from the original donation

4) Laboratory evidence of same Babesia sp. in any other recipient(s) Yes No Unknown

Classification Criteria * Definite: Laboratory evidence of the suspected pathogen in the transfusion recipient AND Evidence that the recipient was not infected with this organism prior to transfusion AND either one of the following:

Laboratory evidence of infection with the same organism in the donor by testing of the donor, the recipient unit (or retained segment), or cocomponent from the original donation OR Laboratory evidence of infection with the same organism in another recipient that received blood from the same donor

Probable: Laboratory evidence of the suspected pathogen in the transfusion recipient AND any two of the following:

Evidence that the recipient was not infected with this organism prior to transfusion OR Laboratory evidence of infection with the same organism in the donor by testing of the donor, the recipient unit (or retained segment), or cocomponent from the original donation OR Laboratory evidence of infection with the same organism in another recipient that received blood from the same donor

Possible: Recipient infection fails to meet imputability criteria for definite or probable because essential information is missing, not available, or cannot be obtained. * Adapted from the National Healthcare Safety Network’s transfusion-transmitted infection case definition criteria: (http://www.cdc.gov/nhsn/TOC_BIOManual.html).

CDC 50.15 3A (E), January 2012, CDC Adobe Acrobat 10.1 , S508 Electronic Version, January 2013

Investigation #: ________________


Transfusion-Associated Babesiosis: Investigation Form

Contact information

CDC (Centers for Disease Control and Prevention), Parasitic Diseases Branch

Phone: (404) 718-4745 Email: [email protected]

AABB (formerly, the American Association of Blood Banks)

Phone: Email: [email protected]

Transfusion Service(s)

Agency Name: Point of Contact:

Phone: Email:


Phone: Email:

Blood Collection Agency(ies)


Phone: Email:


Phone: Email:

Location of transfusion(s): Medical Facility(ies)


Phone: Email:


Phone: Email:

Treating Hospital(s)/Facility(ies)


Phone: Email:


Phone: Email:

Health Department(s)


Phone: Email:


Phone: Email:


Investigation #: ________________


Transfusion-Associated Babesiosis: Recipient Information Initial (Index) Recipient Additional (Non-Index) Recipient Case ID# CDC Case Status (CDC case classification): Confirmed Probable Suspect Unknown Demographics Sex: Male Age: days months years Race American Indian or Alaska Native

Female (select all Asian or Pacific Islander Unknown that apply): Black/African American

White Other, specify: __________ Unknown

State of residency:

Transfusion information Summarize the number and type of cellular components transfused in the year (12-month period) before diagnosis. ___ RBC (___ liquid, ___ frozen, ___ apheresis) Use the generic Transfusion-Transmitted Infections

form to track donations and identify implicated donor(s). ___ platelet (___ concentrate, ___ apheresis) Date(s) of relevant transfusion(s): __________, __________, __________ Reason(s) for relevant transfusion(s): Surgery Trauma Underlying medical condition Other: _______

Diagnostic testing (approximate dates [mm/yyyy] are acceptable) Date of diagnosis (mm/dd/yyyy): __________ Not applicable Unknown Were any pre-transfusion specimens tested for evidence of Babesia infection? Yes No Unknown If yes, specify pertinent test(s) and results: Test type


Specimen Date specimen

collected Babesia species

Titer Result

Were any post-transfusion specimens tested for evidence of Babesia infection? Yes No Unknown If yes, specify pertinent test(s) and results: Test type


Specimen Date specimen

collected Babesia species

Titer Result

Did the recipient receive antimicrobial treatment for Babesia infection? Yes No Unknown If yes, which drugs Clindamycin Quinine Atovaquone Azithromycin Other: ___________ (select all that apply)?

Clinical information (approximate dates [mm/yyyy] are acceptable) Date of symptom onset (mm/dd/yyyy): __________ Not applicable Unknown Clinical manifestations (select all that apply) Yes No Unk Yes No Unk Yes No Unk Fever Headache Myalgia Anemia Chills Arthralgia Thrombocytopenia Sweats Other clinical manifestations (specify):

CDC 50.153A (E), January 2012, CDC Adobe Acrobat 10.1, S508 Electronic Version, January 2013

Investigation #: ________________


Transfusion-Associated Babesiosis: Recipient Information (cont.) Underlying medical conditions (select all that apply; approximate dates [mm/yyyy] are acceptable) Sickle cell anemia Leukemia/lymphoma Allogeneic stem cell transplant Thalassemia Other cancer, specify: ________ Other transplant, specify: ___________ Other hemoglobinopathy Other anemia, specify: ________ Other thrombocytopenia, specify: ________ Not applicable Unknown

Is the recipient asplenic? Yes No Unknown Functionally asplenic? Yes No Unknown If splenectomy, date of surgery (mm/dd/yyyy): __________ Unknown

History of diagnosis or treatment of other tickborne Lyme disease Anaplasmosis Ehrlichiosis diseases (select all that apply): Other: ___________ Unknown

Risk factors (in addition to transfusion) Is there a possibility that this case was tick transmitted? Yes No Not applicable Unknown Is there a possibility that this case was congenital? Yes No Not applicable Unknown If yes, was the patient’s mother tested for evidence of Babesia infection? Yes No Unknown If yes, what were the results of the testing? Positive Negative Indeterminate Unknown In the year (12-month period) before the relevant blood transfusion, did the recipient: Live in/travel to the Northeast or upper Midwest? Yes No Unknown

If yes, indicate where, how long (<1 week, 1–4 weeks, 5 or more weeks), and whether any part of that time was during June–September (select all that apply): Connecticut ___________ June–Sept New Jersey ___________ June–Sept Maine ___________ June–Sept New York ___________ June–Sept Maryland ___________ June–Sept Pennsylvania ___________ June–Sept Massachusetts ___________ June–Sept Rhode Island ___________ June–Sept Minnesota ___________ June–Sept Vermont ___________ June–Sept New Hampshire ___________ June–Sept Wisconsin ___________ June–Sept

Engage in outdoor activities? Yes No Unknown If yes, indicate which, where, and whether any of that time was during June–September (select all that apply): Camping Where? _____ June–Sept Outdoor sports Where? _____ June–Sept Hiking Where? _____ June–Sept Gardening Where? _____ June–Sept Hunting Where? _____ June–Sept Work related Where? _____ June–Sept Other: Where? _____ June–Sept Spend time in or near wooded or brushy areas? Yes No Unknown Notice any tick bites? Yes No Unknown When (date)? __________ Where?

Notes:


Investigation #: ________________


Transfusion-Associated Babesiosis: Donor Information

Case Status (CDC case classification): Confirmed Probable Suspect Unknown Case ID# Demographics Sex: Male Age: years Race (select American Indian or Alaska Native

Female all that apply): Asian or Pacific Islander Unknown Black/African American

White

Other, specify: ___________ Unknown

State of residency:

Donation information (approximate dates [mm/yyyy] are acceptable) Date(s) of relevant donation(s): __________, __________, __________

For the index donation: Was a retained segment or cocomponent tested for evidence of Babesia infection? Yes No Unknown If yes, what were the results of the testing? Positive Negative Indeterminate Unknown Were there additional recipients of cellular components from the index donation? Yes No Unknown

For other donations: Were there recipients of cellular components? Yes No Unknown Donor diagnostic testing Specify pertinent tests(s) and results:

Test type Testing facility

(name, city, state) Specimen

Date specimen collected

Babesia species

Titer Result

Did the donor receive antimicrobial treatment for Babesia infection? Yes No Unknown

If yes, which drugs Clindamycin Quinine Atovaquone Azithromycin Other: ___________ (select all that apply)? Clinical information (approximate dates [mm/yyyy] are acceptable) Date of diagnosis (mm/dd/yyyy): __________ Unknown Date of symptom onset (mm/dd/yyyy): __________ Not applicable Unknown

Symptoms (if any) before relevant donation(s): Symptoms (if any) after relevant donation(s): Other clinical manifestations (if any):

History of diagnosis or treatment of other tickborne Lyme disease Anaplasmosis Ehrlichiosis

diseases (check all that apply): Other: _____________________ Unknown


Investigation #: ________________


Transfusion-Associated Babesiosis: Donor Information (cont.)

Risk factors In the year (12-month period) before the relevant blood donation(s), did the donor: Live in/travel to the Northeast or upper Midwest? Yes No Unknown

If yes, indicate where, how long (<1 week, 1–4 weeks, 5 or more weeks), and whether any part of that time was during June-September (select all that apply): Connecticut ___________ June–Sept New Jersey ___________ June–Sept Maine ___________ June–Sept New York ___________ June–Sept Maryland ___________ June–Sept Pennsylvania ___________ June–Sept Massachusetts ___________ June–Sept Rhode Island ___________ June–Sept Minnesota ___________ June–Sept Vermont ___________ June–Sept New Hampshire ___________ June–Sept Wisconsin ___________ June–Sept

Engage in outdoor activities? Yes No Unknown If yes, indicate which, where, and whether any of that time was during June-September (select all that apply): Camping Where? _____ June–Sept Outdoor sports Where? _____ June–Sept Hiking Where? _____ June–Sept Gardening Where? _____ June–Sept Hunting Where? _____ June–Sept Work related Where? _____ June–Sept Other: Where? _____ June–Sept Spend time in or near wooded or brushy areas? Yes No Unknown Notice any tick bites? Yes No Unknown When (date)? __________ Where? Notes:

CDC 50.15 3A (E), January 2012, CDC Adobe Acrobat 10.1, S508 Electronic Version, January 2013

babesiosis investigation guideline• when interpreting ifa igg or total ig results, it is helpful...

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