Recommendations for the Notification of Recipients of a Blood Component Recall
Mindy Goldman, MD
Lakshmi Rajappannair, MD
List of Abbreviations
Canadian Blood Services
Epstein Barr Virus
Not Applicable
National Advisory Committee for Blood and Blood Products
Nucleic Acid Testing
National Recipient Advisory Committee
Provincial / Territorial Canadian Blood Services Blood Liaison Committee
Transmissible Disease
Transfusion Medicine
Transfusion Related Acute Lung Injury
Associated Blood Component – a blood component that is directly associated in a recall
Companion Blood Component – a blood component that has been produced from the same donation.
Large Scale Recall – a recall of a large number of blood components involving multiple provinces or a single province, OR, a recall of a small number of blood components involving multiple provinces or a single province. This does not include reasons for common recalls outlined in this document.
Recall – the removal from further distribution, or use, of a product (blood component) that violates legislation administered by Health Canada (a regulatory requirement).
Unusual Recall – a recall due to an unanticipated event impacting a large or small number of blood components
Withdrawal – the voluntary removal by the manufacturer (blood supplier) of a product (blood component) that does not violate legislation administered by Health Canada.
| Page | Detail |
|---|---|
| 7 | Under 3.8, removed recommendation for consultation re: donor re‐testing as this step is not likely to be helpful |
| 9 | Clarified title of Table 1 |
| 9 | Added category to Table 1: Possible donor infection in donor with a travel history (not related to malaria risk) |
| 10 | Added category to Table 1: Zika virus infection, lab confirmed |
| 10 | Updated list of most common unacceptable medications in Table 1 |
| 10 | In the Mononucleosis category in Table 1, edited the Notification criteria |
| 10 | Updated relative risk of recalls due to variant CJD versus classic CJD in Table 1 |
| 10 | Removed category “Miscellaneous – Vaccinations” from Table 1 owing to very low frequency of recalls |
| 10 | Updated the % of total recalls captured within the reason list in Table 1 |
| 11 | Clarified title of Table 2 |
| 11 | Updated BacT/ALERT testing / Quality Control section in Table 2 to reflect new platelet testing process and edited the Notification criteria |
| 11 | Updated examples of screening errors in Table 2 |
| 11 | Removed category “Appearance” from Table 2 owing to very low frequency of recalls |
| 11 | In the Sterility Breach category in Table 2, edited the Notification criteria |
| 12 | In the Unacceptable QC WBC results category in Table 2, edited the Notification criteria |
| 12 | Updated the % of total recalls captured within the reason list in Table 2 |
| 16 | Updated Section 10 (Acknowledgements) |
| 18 | Added information on ‘Possible donor infection in donor with a travel history (not related to malaria risk)’ to Appendix A |
| 18 | Updated deferral period for tattoo and piercing in Appendix A |
| 18-19 | Updated information on vCJD and classical CJD in Appendix A |
| 19 | Removed category “Miscellaneous – Vaccinations” from Appendix A owing to low frequency of recalls |
| 20 | Added information on ‘Zika virus infection, lab confirmed’ to Appendix A |
| 20 | Updated Invalid BacT/Alert Testing section in Appendix A to reflect new platelet testing process |
| 20 | Removed category “Appearance” from Appendix A owing to low frequency of recalls |
| 23-26 | Updated references |
The National Advisory Committee on Blood and Blood Products (NAC) is an interprovincial medical and technical advisory body to the provincial and territorial health ministries and the blood supplier Canadian Blood Services (CBS). Its mandate is to provide professional leadership and advice in matters directly affecting the practice of transfusion medicine in hospitals. In 2010, NAC was asked by the Provincial / Territorial Canadian Blood Services Blood Liaison Committee (P/T CBS BLC) to:
- Develop national recommendations ensuring consistent recipient notification when a recall or a withdrawal of a blood component has occurred;
- Identify who is responsible for each stage of the notification process;
- recommend a group of resource experts that would be convened in the event of an unusual or large scale recall/withdrawal to provide direction regarding recipient notification for a situation that is not specifically addressed in the national recommendation document.
NAC collaborated with Canadian Blood Services in the development of this recommendation document. It is recommended that this document be used as a reference by hospital transfusion services, the blood supplier and Provincial / Territorial representatives.
Although the definition for a recall or a withdrawal of blood components differ (refer to the list of definitions); from a practical perspective the consequences for the blood component is the same. The blood supplier removes the blood component from inventory and hospital transfusion services supplied by CBS are notified if they have received associated or companion blood components. This document does not distinguish between the two terms. The term ‘recall’ is used as a comprehensive term throughout the remainder of the document.
The recommendations for recipient notification outlined in this document are the suggested actions required in terms of notification. The general recommendations presented are applicable to causes of blood component recalls that are known to occur and initiated by the blood supplier; the blood supplier being CBS in all provinces and territories with the exception of Quebec. This document does not prevent provinces, territories or individual hospitals from implementing notification processes above and beyond what has been recommended, or modifying processes as determined locally.
It is recommended that all hospitals have their own policies and procedures for the process of notification in accordance with applicable provincial regulations. Throughout this document when notification is recommended every hospital should have an internal procedure outlining who is responsible for notification and the process by which it should occur. It is recommended that local risk management be consulted in the development of this process.
This document does not address recalls initiated due to a donor testing positive for a transmissible disease test. i.e., Hepatitis B, Hepatitis C, HIV, HTLV, Syphilis, WNV or T.cruzi (Chagas disease). In these instances, CBS indicates to the hospital the required actions via standard lookback procedures.
The clinical situation of the recipient is an important factor when considering notification of a blood component recall. These recommendations for notification have been made in consideration of the available literature. The clinical situations of recipients that may be considered by the treating physician in further evaluating the recommendations for notification contained in this document include, but are not limited to:
- Presence or absence of symptoms during or after transfusion (relevant for possible bacterial contamination, malaria risk)
- Pregnancy (relevant for teratogenic drugs)
- Underlying condition (relevant if patient is immunocompromised and donor developed EBV infection)
- The age of the patient
- Relevant prognosis
Depending on the age and prognosis of the recipient; the treating physician may consider notifying next of kin or family members as an alternative to notifying the recipient directly about a blood component recall. This should be done in accordance with applicable provincial regulations.
For instances where recipient notification is not recommended and a review of recipient records are required to confirm this, it is recommended that hospitals maintain a record of their activities related to the review of information as appropriate. Recipient notification and any follow‐up testing should occur as soon as possible in relation to the relative risk that is associated with the cause of the blood component recall.
It is recommended that consultation with a CBS Medical Director occur as necessary should further information or clarification be required with respect to any notification received regarding a blood component recall.
This document currently only addresses recipient notification in terms of recalls associated with the transfusion of fresh blood components collected, produced and distributed by CBS (i.e., red blood cell, platelet and frozen plasma components). However, there may be applicability to a recall of fractionated or recombinant plasma protein products i.e., an unusual or large scale recall. The National Recipient Advisory Committee (NRAC) in Section 9 may be convened.
Recalls and withdrawals of blood products are initiated by CBS in accordance with Health Canada regulations and standard operating procedures.
Once CBS makes the decision to recall or withdraw blood components from inventory, the required notification to hospitals is conducted as per standard procedure. If on notification the hospital concludes that the identified blood component was transfused, a decision with regard to recipient notification must be made.
For recalls associated with infectious disease markers, CBS will provide direction to hospitals regarding recipient notification in accordance with lookback procedures. As per Figure 1, if the reason to recall a blood component is unusual or if the recall involves a large amount of blood components, a recommendation for recipient notification may be made by the National Recipient Advisory Committee (NRAC). The recommendation made by the NRAC will be communicated to hospitals by CBS through regular communication methods. In these instances hospital reference to the NAC Recommendations for Recipient Notification is not required unless information with respect to the functionality and scope of the NRAC is needed.
Table 1: Recalls initiated as a result of post donation information received by the blood supplier
| Reason | Description / Rationale |
Notification Recommendation |
Notification NOT Recommended |
|
|---|---|---|---|---|
| Cancer | There are no documented cases of transfusion‐transmitted cancer See Appendix A. | N/A |
√ |
|
| Malaria Risk |
History of, Travel to, or Residence in an endemic area. Vast majority, 94%, are travel related. See Appendix A. |
Confirmed case with history of blood donation. | Donor traveled to a malaria risk zone. | |
| High Risk Behaviour |
Includes donors who had MSM, partners with unknown backgrounds, IV drug use, intranasal cocaine, household contact with HCV/HBV. See Appendix A |
√ |
Contact CBS to determine if the donor is available for repeat testing . The donor has screened negative (via subsequent donation or follow up testing) for the marker. |
|
| Tattoo / Piercing / Electrolysis |
These activities are a weak risk of transmission of a viral disease provided they are performed under good conditions, disinfection techniques and with the use of single use needles. See Appendix A |
N/A |
√ |
|
| Possible donor infection, including cold, flu, diarrhea, fever |
Immunocompromised patients may be at risk. Other pathogens (such as Dengue fever) should be considered. See Appendix A |
If within the first week after transfusion of suspect unit, contact attending physician to assess immune status of recipient and potential risk. Notification is only required if a clinically significant reaction was observed in the recipient within three to seven days after transfusion. |
Majority do not require notification. | |
| Viral |
Mumps, rubella, rubeola (measles) rash, chicken pox, Primary Herpes Simplex 1 or II, disseminated herpes zoster, or shingles (68% in this category were shingles). There are no known reported cases of transfusion transmission. See Appendix A |
Contact attending physician to assess immune status of recipient and potential risk. |
√ |
|
| Zika virus infection, lab confirmed |
Rare transfusion‐transmitted cases have been reported. See Appendix A. |
Contact attending physician if recipient may be pregnant. | Majority do not require notification. | |
| Medication, unacceptable |
Most common ‐ Finasteride, Dutasteride See Appendix A. |
Contact attending physician to assess immune status of recipient and potential risk. Notification is only required if a clinically significant reaction was observed in the recipient within three to seven days after transfusion or the donor develops a clinically significant episode | If the donor develops a clinically insignificant episode (or none) and no reaction was observed in the recipient within three to seven days after transfusion. | |
| variant CJD Risk: Donor travel to an at risk country |
96% of recalls are due to variant CJD risk. See Appendix A. |
N/A |
√ |
|
| CJD Risk: Donor disclosed risk factor or developed classical CJD | N/A |
√ |
||
| Miscellaneous – Medical Conditions | Hematological, positive external testing for WNV, Lyme disease / tick bites, tuberculosis | N/A | Majority do not require notification. Consult CBS Medical Director as required. | |
Note: The reasons listed above account for approximately 100% of the total annual recalls in this category (based on CBS 2017/18 data).
Table 2 – Recalls initiated by the blood supplier owing to technical manufacturing issues
| Reason |
Description / Rationale (including but not limited to) |
Notification Recommended | Notification NOT Recommended |
|---|---|---|---|
| BacT/ALERT testing / Quality Control |
Includes errors that lead to invalid results (e.g. taking sample prior to 36 hours from collection; incomplete, incorrect, missing documentation; incorrect incubation and failure to hold following innoculation). See Appendix A. |
If the recipient experienced symptoms (i.e., developed fever, chills, or other signs of sepsis during or in the hours post‐transfusion); recipient blood cultures are recommended. | If the recipient was asymptomatic at the time of transfusion. |
| Screening Error |
Incorrect assessment or documentation by RN/screener, donor registered incorrectly (wrong gender). Includes errors from Registration to Collection. See Appendix A. |
If specifically requested by the manufacturer for the given situation. |
√ |
| Documentation Errors |
Incorrect assessment or documentation by RN/screener, donor registered incorrectly (wrong gender). Includes errors from Registration to Collection. See Appendix A. |
If specifically requested by the manufacturer for the given situation. |
√ |
| Labelling Error | See Appendix A | If specifically recommended by the manufacturer for the given situation |
√ |
| Component production | Extraction errors, in process storage or processing times or conditions incorrect, unacceptable volume, inadequate SAGM added to RBCs. | CBS will provide hospitals with information on the precise reason for recall and the possible clinical risks to recipients. | |
| Retrieval / Release Related | Majority are issues with improper storage or documentation of storage; units not quarantined after improper site transfer conditions. | CBS will provide hospitals with information on the precise reason for recall and the possible clinical risks to recipients. | |
| Sterility breach |
Incomplete seals, leaks found in companion components; incomplete arm prep or clamping errors during collections. See Appendix A |
If the recipient experienced symptoms (i.e., developed fever, chills, or other signs of sepsis during or in the hours post‐transfusion); recipient blood cultures are recommended. | If the recipient was asymptomatic at the time of transfusion. |
| Rh D or red cell antigen phenotyping errors |
Errors/discrepancies with phenotyping testing. See Appendix A |
Alloimmunized patients should be observed for hemolysis. Patients receiving antigen negative units to prevent alloimmunization may be retested to determine if they have developed an antibody. |
√ |
| Unacceptable (elevated) QC WBC results | See Appendix A. | Contact attending physician to assess immune status of recipient and potential risk of serious CMV infection. Notification is required only if there is a concern of possible recipient illness due to underlying clinical status. |
√ |
Note: The reasons listed above account for 98% of the total annual recalls in this category (based on CBS 2017/18 data).
Table 3: Recalls initiated as a result of the possibility of bacterial contamination in a blood component
| Reason | Description / Rationale | Notification Recommended | Notification NOT Recommended |
|---|---|---|---|
| Positive Bac T/ALERT culture | See Appendix A | Recipient notification and testing (blood cultures) is recommended in a recipient who developed fever or other signs of sepsis during or in the hours following transfusion. Clinical judgment is necessary to assess if blood cultures are necessary in a patient who is already on antibiotic therapy and has not experienced any symptoms post‐ transfusion. | NA |
| Contamination or possible contamination of companion component | See Appendix A | Inspection, Gram stain, and culture of any residual transfused component may be performed if the bag is still available. Notification and blood cultures are recommended if the recipient was recently transfused and developed fever or other signs of sepsis during or in the hours post‐transfusion. Since the likelihood of actual bacterial contamination is low, clinical judgment is required to determine the need and urgency of blood cultures and other possible actions. | NA |
Table 4 : Recalls initiated as a result of the possibility of bacterial contamination in a blood component
| Reason | Description / Rationale | Notification Recommended | Notification NOT Recommended |
|---|---|---|---|
| A companion blood component has been associated with a TRALI reaction |
Note: CBS is not aware of any cases where 2 recipients of components from the same donation developed TRALI (recipient with target antigen and volume of plasma in transfused component). See Appendix A. |
Assess recipient health record for transfusion reaction occurring within 12 hours of transfusion and notify attending physician if TRALI is suspected. | NA |
In the event that an unusual situation triggers a recall of blood components, or a large number of blood components are involved in a recall, it is recommended that the National Recipient Advisory Committee (NRAC) be convened to make recommendations regarding recipient notification. This group of resource experts may also be convened to provide recommendation regarding recipient notification for recall situations that are not currently addressed in the preceding sections of this document.
CBS will accept the NRAC recommendation as the principal consideration in rendering a decision regarding recipient notification.
The Terms of Reference for this committee are as follows:
7.1 Mandate
The National Recipient Advisory Committee (NRAC) will develop recommendations and provide advice to Canadian Blood Services (CBS) with respect to recipient notification in the event of a blood component recall situation that involves a large number of blood components or if the situation is not currently addressed in available national recommendations.
Prior to convening the larger secondary NRAC, the primary NRAC may be convened to discuss the recall situation.
To this end the primary NRAC will:
- discuss if recipient notification is required
- determine if the secondary NRAC committee should be convened
- develop strategies and next steps for consideration and discussion by the secondary NRAC (as applicable)
To this end the secondary NRAC (if convened) will:
- develop a recommendation for consistent recipient notification across the country with respect to specific recall scenarios
- indicate if follow‐up testing should be considered for recipients that were transfused impacted blood components
- provide recommendations regarding the communications issued to hospitals via CBS
7.2 Membership
The Chair of the primary and secondary NRAC will be the current chair of the National Advisory Committee on Blood and Blood Products (NAC). The Vice‐Chair of NAC shall act as chair in the absence of the NAC Chair.
Primary NRAC
- CBS Chief Supply Chain Officer
- NAC Chair and Vice Chair (or designates)
- CBS Vice President, Medical Affairs and Innovation
- Blood Portfolio Lead Province Representative
- Additional expertise as required
Secondary NRAC
- Members of the Primary NRAC (if not also a member of the established NEBMC)
- Members of the established National Emergency Blood Management Committee (NEBMC)
- A provincial legal representative (Lead Province Blood Portfolio)
- Two blood transfusion recipient representatives; one should be an actual blood transfusion recipient (past or present) and the other should be a representative of an appropriate patient society
- Ethicist
- Public Health Agency of Canada representative
- CBS Vice President Quality Assurance and Regulatory Affairs
Every member of the primary and secondary NRAC is responsible for naming a designate in the event that he/she is unavailable. The primary and secondary NRAC may invite additional experts to meetings on an ad hoc basis to provide expertise on the subject matter being discussed.
Meetings
Meetings will be convened at the request of CBS or the Chair as required. Decisions of the primary and secondary NRAC will be made by consensus. Consensus is defined as 80% (or greater) agreement of the voting members present. In the event that consensus cannot be reached at the primary NRAC level, the secondary NRAC will be convened. In that event that consensus cannot be reached at the secondary NRAC level, CBS will make decisions considering the advice received from the NRAC. The NEBMC Secretariat will arrange teleconferences/meetings and record and distribute minutes of the meetings/ record of decisions, maintain the membership list and respective contact information for both the primary and secondary NRAC.
NAC and CBS wish to acknowledge Dr. Mindy Goldman and Dr. Margaret Fearon, Canadian Blood Services and Nancy Heddle, McMaster University, for their valued contributions in the development of the initial version and Drs. Goldman and Fearon for ongoing refinement of medical sections of this document.
References
GENERAL
Canadian Disclosure Guidelines. Canadian Patient Safety Institute; May 2011. Available online at:https://www.patientsafetyinstitute.ca/en/toolsResources/disclosure/Documents/CPSI%20Ca nadian%20Disclosure%20Guidelines.pdf#search=Canadian%20Disclosure%20Guidelines
Heddle, Nancy M. et al. "TRANSFUSION SERVICE: A policy informing qualitative study to improve the process of blood product recalls and withdrawals." Transfusion 48.12 (2008):2585‐ 2595.
Recommandations pour la Notification des Receveurs a la Suite d’un Retrait de Produits Sanguins. Quebec : Gouvernement du Quebec. SeSS; 2004. Eder AF, Goldman M. Postdonation Information and Blood Component Retrievals: Realigning Blood Center and Hospital Actions Based on Risk Assessment. Transfus Med Rev 2014; 28:226‐ 234.
Ramsey G. Blood component recalls and market withdrawals: frequency, reasons, and management in the United Status. Transfus Med Rev 2013; 27:82‐90.
Lindholm PF, Annen K, Ramsey G. Approaches to minimize infection risk in blood banking and transfusion practice. Infect Disord Drug Targets 2011; 11(1):45‐56.
BacT/ALERT, invalid testing
Jenkins C, Ramirez‐Arcos S, Goldman M, Devine DV. Bacterial contamination in platelets: incrementatal improvements drive down but do not eliminate risk. Transfusion 2011;51:2555‐ 65.
BACTERIAL CONTAMINATION
Positive BacT/ALERT, contamination or possible contamination of companion component Bacterial Contamination of Platelets: Summary for Clinicians on Potential Management Issues Related to Transfusion Recipients and Blood Donors. AABB Bacterial Contamination Task Force, Feb 23, 2005. Available online at: http://aabb.org/advocacy/regulatorygovernment/bloodcomponents/platelets/Documents/bact contplat022305.pdf
Guideline for Investigation of Suspected Transfusion Transmitted Bacterial Contamination, PHAC, CCDR 2008;34S1. Available online at: http://www.phac‐aspc.gc.ca/publicat/ccdr‐rmtc/08vol34/34s1/34s1‐eng.php
Eder A, Goldman M. How do I investigate septic transfusion reactions and blood donors with culture‐positive platelet donations. Transfusion 2011; 51:1662.
CANCER
Edgren G, Hjalgrim H, Reilly M, et al. Risk of cancer after blood transfusion from donors with subclinical cancer: a retrospective cohort study. The Lancet 2007; 369:1724‐1730. Yang H, Lee J, Seed CR, Keller AJ. Can Blood Transfusion Transmit Cancer? A Literature Review. Transfus Med Rev 2010; 24:235‐243.
CJD
Dorsey K, Sou S, Schonberger LB, Sullivan M, et al. Lack of evidence of transfusion transmission of Creutzeldt‐Jakob disease in a US surveillance study. Transfusion 2009; 49:977‐984. Hewitt PE, Llewelyn CA, Mackenzie J, Will RG. Creutzfeldt‐Jakob disease and blood transfusion: results of the UK Transfusion Medicine Epidemiological Review study. Vox Sang 2006; 91:221‐ 230.
vCJD risk areas (travel or transfusion)
Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt‐Jakob Disease (CJD) and Variant Creutzfeldt‐Jakob Disease (vCJD) by Blood and Blood Products. FDA 2002; 1:23. Available online at: www.fda.gov/cber/guidelines.htm www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ Guidances/Blood/UCM307137.pdf
Davidson LRR, Llewelyn CA, Mackenzie JM, Hewitt PE, Will RG. Variant CJD and blood transfusion: are there additional cases? Vox Sang 2014; 107:220‐225.
Seed CR, Hewitt PE, Dodd RY, Houston F, Cervenakova L. Creutzfeldt‐Jakob disease and blood transfusion safety. Vox Sang. 2018;113:220‐231.
Urwin PJ, Mackenzie JM, Llewelyn CA, Will RG, Hewitt PE. Creutzfeldt‐Jakob disease and blood transfusion: updated results of the UK Transfusion Medicine Epidemiology Review study. Vox Sang. 2016;110:310‐316.
HIGH RISK BEHAVIOUR
O’Brien SF, Yi QL, Fan W, et al. Current incidence and residual risk of HIV, HBV, and HCV at Canadian Blood Services. Vox Sang 2012; 103:83‐86.
INFECTION
Possible donor infection, including cold, flu, diarrhea, fever Goldman M, Long A, Roy G, et al. Incidence of Positive Bacterial Cultures after Donor Call‐Back. Transfusion 1996; 36:1035.
Eder AF, Goldman M. How do I investigate septic transfusion reactions and blood donors with culture‐positive platelet donations? Transfusion 2011; 51:1662‐1668.
Possible viral infection
Stramer SL, Hollinger FB, Katz LM, Kleinman S, et al. Emerging infectious disease agents and their potential threat to transfusion safety. Transfusion 2009 Supplement 49.
- Herpes simplex viruses 1 and 2, varicella zoster (chicken pox, shingles): 96S‐98S.
- Influenza A or B viruses: 110S‐112S
- Mumps virus: 133S‐135S
- Mononucleosis (Epstein‐Barr Virus): 78S‐79S
Measles, Mumps, Rubella
Degree and length of viremia in adults with measles. D. N. Forthal, S. Aarnaes, J. Blanding, L. de la Maza, and J.G. Tiles. J.I.D. 1992;166:421‐4
Blood-borne transmission of the measles, mumps, and rubella vaccine virus. S.Shin, S. Lee, Y. Cho, Y. Shin. Transfusion 2011;51:663‐664
Varicella, Zoster, Herpes simplex I and II
Herpesvirus prevalence and viral load in healthy blood donors by quantitative real time polymerase chain reaction. S. D. Hudnall, T. Chen, P. Allison, S.K. Tyring and A. Heath. Transfusion 2008;48:1180‐1187.
Comparison of quantitations of viral load in Varicella and Zoster. H. Kimura, S. Kido, T. Ozaki et al . J.Clin.Micro. 2000; 38(6) :247.
Emerging infectious disease agents and their potential threat to transfusion safety. S.Stramer, B. Hollinger, L. Katz et al . A supplement to Transfusion 2009;49, #25
Chan HM, Ho PL, Chan KH, Lin CK, Lee CK. Interdiction of a blood donation containing varicella‐ zoster virus by donor self‐report of chickenpox. Vox Sang 2013; 104:248‐249.
Zika virus
Barjas‐Castro ML, Angerami RN, Cunha MS et al. Probable transfusion‐transmitted Zika virus in Brazil. Transfusion. 2016;56:1684‐1688.
Saá P, Proctor BS, Foster BA et al. Investigational testing for Zika virus among U.S. blood donors. N Engl J Med. 2018;378:1778‐88.
MALARIA
Mungai M, Tegtmeier G, Chamberland M, Parise M. Transfusion‐transmitted malaria in the United States from 1963 through 1999. N Engl J Med 2001; 344:1973‐1978.
Cullen KA, Arguin PM. Malaria Surveillance – United States, 2012. MMWR 2014/63(SS12); 1‐22. Available online at: http://www.cdc.gov/mmwr/preview/mmwrhtml/ss6312a1.htm
Spencer B, Steele W, Custer B, Kleinman S, et al. Risk for malaria in United States donors deferred for travel to malaria‐endemic areas. Transfusion 2009; 49:2335‐2345.
Spencer B, Kleinman S, Custer B, et al. Deconstructing the risk for malaria in United States donors deferred for travel to Mexico. Transfusion 2011; 51(11):2398‐2410.
MEDICATION, UNACCEPTABLE
Han JY, Choi JS, Chun JM, Park HD, et al. Pregnancy outcome of women transfusion during pregnancy with blood products inadvertently obtained from donors treated with acitretin. J Obs Gyn 2009; 29:694‐697.
Motherisk Website. www.motherisk.org
TATTO / PIERCING / ELECTROLYSIS
Goldman M, Xi G, Yi QL, Fan W, et al. Reassessment of deferrals for tattooing and piercing. Transfusion 2009; 49:648‐654.
TRALI
Toy P, Gajic O, Bacchetti P, et al. Transfusion‐related acute lung injury: incidence and risk factors. Blood 2012; 119(7):1757‐1767.
Appendices
POST‐DONATION INFORMATION
Cancer
Donors who have had most forms of cancer are deferred from donation. Donors reporting a diagnosis of cancer post‐donation are a frequent cause of post‐donation information. Components are recalled if they may still be untransfused at the time the information is obtained (up to 12 months from donation for plasma or cryoprecipitate). A large Scandinavian cohort study of cancer incidence in recipients of blood from donors who had subclinical cancer at the time of donation demonstrated no excess risk of cancer compared to recipients who had received blood from donors who did not develop cancer post‐donation. The FDA found no evidence that development of cancer in donors affected the safety, purity or potency of blood components, and does not require recall of components after a diagnosis of cancer is made in donors.
Malaria Risk
Recalls are usually due to unreported malaria risk travel. Cellular components are recalled if the donor left an at risk area 6 months or less prior to donation. The overall risk of transfusion‐ transmission of malaria in the US and Canada is estimated as less than 1 per million cellular components transfused. Since 1997, there have been no cases of transfusion‐transmitted malaria reported in Canada, and approximately 1 to 2 cases of transfusion‐transmitted malaria reported annually in the US. Cases are most commonly associated with donors who are immigrants from malaria‐risk areas, rather than short‐term travelers. Symptoms and signs of post‐transfusion malaria include fever, fatigue, anemia, and altered mental status, usually developing from 2 to 3 weeks post‐transfusion for falciparum malaria. The incubation period may be longer after other species, and up to 73 days for P. malariae.
High Risk Behaviour
Occasionally, donors report high risk behaviour, such as illicit intravenous drug use that would have led to indefinite deferral. Components are recalled if such behaviour occurred recently. Since infectious disease testing at the time of donation was negative, risk of disease transmission is likely extremely low. At the present time, the window periods for HIV, HCV, and HBV are estimated at 11, 10, and 39 days respectively. However, recipient infection with any of these viruses may be asymptomatic at the time of transfusion, but have major health consequences both for the individual and their household and sexual contacts.
Possible donor infection, including cold, flu, diarrhea, fever
Donors who develop symptoms such as fever, chills, and diarrhea in the days post‐donation may have been bacteremic at the time of donation. Culture of all platelet components has provided more information about possible sources of asymptomatic bacteremia in donors. Donors in the incubation phase of a gastrointestinal or upper respiratory tract bacterial infection are extremely rarely associated with positive bacterial cultures.
Possible donor infection in donor with a travel history (not related to malaria risk)
Donors with a travel history who develop symptoms such as fever, joint pain with or without rash and conjunctivitis necessarily have a more broad differential diagnosis than donors who have not traveled abroad. Discussion with the CBS Medical Office is recommended, as the further information / testing may narrow the etiology, as is correlation with clinical signs / symptoms in the recipient. For donors with a travel history to areas of malaria risk, refer to Malaria Risk above.
Tattoo, piercing, electrolysis
Donors are temporarily deferred for 3 months after any tattoo and after any piercing, and for 6 months after electrolysis with non‐single use needles. Donors who return after temporary deferral are not at increased risk of positive HBV or HCV infectious markers compared to other donors. Recent tattoo, piercing or electrolysis are not risk factors for HCV or HBV infections in CBS donors. Therefore, there appears to be little increased risk associated with these activities occurring in these time frames prior to donation.
Medication, unacceptable
Blood is recalled if donors are identified to be taking highly teratogenic medications that have been associated with birth defects when taken by pregnant women. However, there is limited data on the risk of a one‐time exposure through blood transfusion. The one published study did not show any adverse outcomes such as malformations in infants of women taking one of these medications, acitretin, before or during pregnancy. Therapeutic efficacy of platelets may be decreased if a donor was taking medication with anti‐platelet effects, such as ASA, at the time of donation. Depending on the medication, some of the platelet function defect may be reversible after transfusion.
Travel or transfusion, vCJD risk area
There have been 4 probable cases of vCJD transmission through blood transfusion. All of these cases occurred in the UK. The involved donors developed vCJD from 17 months to 3.5 years after donation. As of November 2017, 230 vCJD cases have been reported in 12 countries, the majority in the UK (178) and France (27). Non‐UK cases have been linked to previous residence in the UK or residence in other countries with a risk of BSE in the food chain from meat imported from the UK. The risk of transmission of vCJD from donors who have resided in or have been transfused in a vCJD risk area but have not developed vCJD is therefore extremely small.
Health Canada directives do not contain any information regarding notification of recipients. However, the FDA Guidance document referenced below specifically mentions that the FDA does not believe it is appropriate to conduct tracing and notification of recipients of components from donors who have resided in or been transfused in vCJD geographic risk areas.
Classical CJD risk
Donors are deferred for use of human pituitary derived growth factor and gonadotrophin hormones, and for a history of CJD in family members. Donors may report that they or a family member have developed CJD or did not report risk at the time of donation.
Two large cohort studies, one in the UK and one in the US, followed recipients who received blood components from donors who developed CJD. To date, after more than a decade of follow up in over 100 recipients, there has been no evidence of CJD transmission. The FDA Guidance document referenced below specifically mentions that the FDA does not believe it is appropriate to notify recipients of components from donors who develop CJD themselves or whose family members develop CJD.
Mononucleosis (Epstein‐Barr Virus)
As a precautionary measure, all components donated in the 30 days prior to development of mononucleosis are recalled. Transmission of EBV has been documented in immunosuppressed recipients, especially following transplantation. Since EBV is a B lymphocyte associated virus, risk of transmission is substantially decreased by universal leukoreduction. Additionally, life time chronic carriage of the virus occurs in over 90% of the adult population. Therefore most recipients would be expected to be already infected.
Viral
As a precautionary measure, all components are recalled when donors are diagnosed with symptoms of these infections developing up to 7 days post‐donation. Theoretically, the donor may have been viremic at the time of donation. In practice, transmission of these agents has rarely, if ever, been documented.