Reporting Complications of Blood Transfusion to the Blood Supplier

Reporting Serious Adverse Transfusion Reactions (ATR)

The reporting of adverse transfusions reactions (ATR) data is essential for several reasons.

1. It permits a rapid and thorough investigation and timely corrective action, if required, by the CBS Blood Centre.
2. The collection of ATR data is essential for surveillance of the blood system.
3. The data should facilitate the assessment of the quality of patient care provided by the nursing personnel, the quality of the hospital blood bank policies and procedures, and the quality of the blood and blood components obtained from the blood supplier.

To achieve the above objectives, Canadian Blood Services is required to report ATRs to our regulator, Health Canada. For the purpose of reporting, an ATR can be categorized by seriousness and whether or not it is an unexpected ATR as described below.

Note: “Serious Adverse Events” is the standardized term adopted by the National Transfusion Transmitted Injuries Surveillance System, and is synonymous with Adverse Transfusion Reaction (ATR)

• Adverse Transfusion Reaction (ATR) /Event is defined as an undesirable and unintended occurrence to the administration of whole blood or a blood component, whether or not considered to be related to the donation itself.
• Adverse reactions to plasma derivatives are considered Adverse Drug Reactions and regulated by relevant parts in the Food and Drug Regulations.
• Serious Adverse Transfusion Reaction is defined as an adverse event that requires in-patient hospitalization or prolongation of existing hospitalization directly attributable to the event; results in persistent or significant disability or incapacity, necessitates medical or surgical intervention to preclude permanent damage or impairment of a body function, is life- threatening or results in death.
• Unexpected Adverse Transfusion Reaction is a reaction or event not identified in nature, severity or frequency among the currently known adverse effects associated with the transfusion of blood or blood components.

Canadian Blood Services requires notification of all “serious adverse transfusion reactions” that are possibly related to transfusion of blood and blood components manufactured by Canadian Blood Services.

The following adverse events related to blood and blood components should be promptly reported to CBS:

1. All deaths.
2. All serious reactions (immediate threat and/or major deterioration):
   - Major Allergic/anaphylactic reaction,
   - Acute hemolytic reaction,
   - Significant Hyperkalemia, and
   - Delayed hemolytic reactions.
3. All of the following reactions regardless of their severity:
   - TRALI,
   - Graft-versus-Host Disease, and
   - Post-transfusion purpura.
4. All cases of suspected bacterial contamination and/or any positive culture of a product. Canadian Blood Services should be contacted for any suspicious case of bacterial contamination, so that products related to the same donation be rapidly put in quarantine or recalled.
5. All post-transfusion infections (i.e. hepatitis A, parvovirus B19, malaria, Chagas, WNV, etc.).
6. All reactions for which the product quality is doubtful.
7. All unusual reactions (ex. red eye syndrome, severe hypotensive reactions).
8. Any other reaction with the potential for permanent disablement or loss of life.

Adverse reactions such as febrile nonhemolytic reactions, mild to moderate, allergic reactions and delayed serologic reactions would not normally require reporting to CBS but should not be excluded if the attending Physician feels that the severity of the reaction warrants investigation by the CBS Blood Centre.

Health Canada requires that Canadian Blood Services Head Office advise them within 24 hours of a fatal reaction and as soon as possible (within 15 calendar days), of a life-threatening or permanently disabling reaction/event. To comply with this requirement, hospitals should report adverse reactions immediately to the local CBS Blood Centre. Health Canada requires reporting of:

a) all adverse reactions associated with bacteria, parasites or endotoxins, and
b) reactions described as a potential risk in the applicable labelling, packaging or Circular of Information.

Upon the occurrence of a serious adverse reaction, the Hospital Blood Bank/Transfusion Service Medical Director should immediately advise the local CBS Blood Centre and provide the following information on the join form with Health Canada provided by CBS in accordance with the timelines indicated above:

• description of events preceding, during and following the reaction, including date, time, diagnosis, drug history, clinical symptoms and sequelae
• identity of blood components transfused within the previous 24 hours, including unit numbers and date of collection
• pre and post-transfusion testing results
• microbiology testing results on patient and blood components (when available).

Reporting HIV, HBV, HCV and HTLV Infections

As part of its blood safety program, Canadian Blood Services, in addition to excluding high-risk donors and testing all collected units for HIV, HBV, HCV, HTLV, Syphilis and WNV conducts two supplementary activities:

1. When notified of an HIV, HBV, HCV and/or HTLV infection that is possibly transfusion-related, potentially implicated donors who contributed blood to the patient’s care are investigated. The benefits of such a procedure are the following:
   - it contributes to the security of the blood supply. Only those donors meeting certain safety criteria are maintained on the authorized donor list.
   - infected individuals who are unaware that they have ever been at risk may be detected. These donors may benefit from regular medical follow-up and care, and be counselled on ways to avoid transmission of this infection.
2. When blood donors are positive for HIV, HCV and/or HTLV (for antigen, antibody and/or nucleic acid):
   - a lookback is initiated of the deferred donors’ previous donations and an investigation initiated in accordance with established procedures
   (NB: the results of testing for HIV, HCV, HBV and HTLV would have been negative on these previous donations)
   - hospitals that were sent blood or blood components prepared from these donations are notified,
   - treating physicians are asked to test their patient(s), who were transfused with these products, and to inform the CBS Blood Centre of the patient(s) test results. 

In this way, recipients possibly infected following the receipt of potentially contaminated but seronegative blood components from donors who gave in the window period can be identified. These patients can benefit from appropriate medical management and be offered counselling on ways to avoid transmission of infection.

In order to assure effective use of these procedures, the following recommendations are made:

1. All persons with HCV, HIV, HBV and HTLV should be asked, as part of their medical history, if they received blood products.
   Physicians should notify the CBS Blood Centre of all HIV, HBV, HCV, and HTLV infections diagnosed after the receipt of blood products. Notification should be as expeditious as possible. The following information will be requested by the CBS Blood Centre in order to complete the investigation: patient identification, date of birth, sex, hospital where transfusions were administered, hospital chart number, date of transfusions, unit identification number and date of collection of each transfusion. The CBS Blood Centre must be notified regardless of the fact that the patient had other risk factors for acquisition of the infection. When reporting an AIDS case to the public health authorities, the physician must mention that the CBS Blood Centre was notified.
2. Physicians must question their infected patients concerning previous blood donations. If their infected patients donated blood after 1977, the CBS Blood Centre must be immediately notified. This notification must include the name of the donor, date of birth and donor identification number in order to allow the CBS Blood Centre to investigate the donor’s previous donations and appropriately notify hospital blood banks who were sent blood or blood components prepared from these donations.
   If the patient refuses to consent to the release of this information, a physician must still comply with the reporting requirement of public health legislation in his or her province.

Information transmitted to the Blood Centre is kept strictly confidential. When communicating with hospital blood banks, only the unit identification number of the investigated blood components is given.

Reporting WNV Infections

Canadian Blood Services tests all donations for WNV.

When a CBS Blood Centre learns that a blood donor is positive for WNV, the donor is temporarily excluded. The donor is told he/she has been temporarily deferred and he/she is informed of the decision.

If a recipient presents signs/symptoms of WNV infection within 28 days of transfusion, the physician should notify the CBS Blood Centre. Notification should be as expeditious as possible. The following information will be requested by the CBS Blood Centre in order to complete the investigation: patient identification, date of birth, sex, hospital where transfusions were administered, hospital chart number, date of transfusions, unit identification number and date of collections of each transfusion.

The CBS Blood Centre must be notified regardless of the fact that the patient had other risk factors for acquisition of the infection. When reporting positive patients to the public health authorities, the physician should mention that the CBS Blood Centre was notified.

Reporting Other Transfusion- Related Infections

Suspected transfusion-related infections should be reported to the CBS Blood Centre using the forms and procedures provided by Canadian Blood Services. The CBS Blood Centre will then act in a fashion similar to the one described in the Circular of Information, Section A.7, Reporting HIV, HBV, HCV and HTLV Infections, and A.8, Reporting WNV Infections.