A Guide to Reporting Adverse Transfusion Events
The following is a guide for reporting adverse transfusion reactions. It includes links where reporting forms may be found. This guide applies to hospitals in Canada, excluding Quebec.
Why report adverse transfusion events?
It is important that transfusion services report adverse transfusion events because:
- it may result in product recall;
- it may result in donor notification and/or investigation and/or deferral;
- it may result in recipient notification and investigation;
- it is useful for purposes of tracking and trending (for example, a new complication or an unexpected change in frequency of a previously recognized complication);
- it contributes to safer transfusion medicine practice.
Reporting adverse events to blood components
Example of what to report:
Example of what NOT to report:
Adverse event blood component reporting forms are available at:
General information about TRALI can be found at: blood.ca/professionaleducation.
Submit completed form directly to your local Canadian Blood Services Distribution fax number or:
Contact your local Canadian Blood Services Hospital Liaison Specialist if you have questions regarding this process.
Reporting adverse events to plasma protein products
Adverse event to plasma protein products reporting forms are available at:
- Canada Vigilance Adverse Reaction Reporting Form.
- Side effect report form - Health Canada.
- The TTISS reporting form can also be used to report reactions to manufacturers of plasma protein products.
1st: Report to the relevant manufacturer.
2nd: You may also report to Health Canada by submitting the completed reporting form directly to Health Canada.
Transfusion Transmitted Injuries Surveillance System (TTISS)
(For examples: TACO, delayed hemolytic, TAD)
TTISS Reporting Form and the User’s Manual are temporarily unavailable at Public Health Agency of Canada but can be downloaded from the links provided below:
- User’s Manual (Version 3.0).
- TTISS Reporting Form - This form can be used to report adverse reactions due to fresh components as well as Plasma Protein Products.
Information on what to submit can be found in the user’s manual.
Submission may take place on line, or in accordance with local or provincial reporting arrangement
Reporting transfusion transmitted infections
(For examples: hepatitis B virus, hepatitis C virus, human immunodeficiency virus)
These events are reported to Canadian Blood Services through separate Lookback and Traceback procedures using the Transmissible Disease Notification (TDN) Form.
|If you have any questions, please contact your local Canadian Blood Services Medical Officer or your local Hospital Liaison Specialist.|
Understanding the Regulations
According to Health Canada Regulations, it is the manufacturer’s responsibility to report adverse transfusion reactions to Health Canada.
If the adverse reaction was caused by an activity in the hospital that affected the quality/safety/efficacy of the component, it is the hospital’s responsibility to report to the Minister according to the Blood Regulations.
Therefore, adverse transfusion reactions that are suspected…
…blood product related should be reported to Health Canada via the blood product manufacturer (in Canada, outside of Quebec, this would be Canadian Blood Services). These adverse events include for examples Transfusion-Related Acute Lung Injury (TRALI), severe allergic reactions, bacterial contaminations, adverse events due to suspected mislabeling, adverse events due to suspected transfusion transmitted infection.
…plasma protein product related should be reported to Health Canada via the plasma protein manufacturer.
In addition, adverse reactions should be reported to PHAC’s TTISS. These include reactions that are product related, as well as others such as TACO and delayed hemolytic.
- 4.1.2 (g)
- 18 - Adverse Events
Canadian Blood Services
- Food and Drugs Act (R.S.C., 1985, c. F-27)
- Blood Regulations (SOR-2013-178)
- Food and Drug Regulations (C.R.C., c. 870)
- Guidance Document: Blood Regulations
See more information on the Health Canada website.
Public Health Agency of Canada (PHAC)
- Transfusion Transmitted Injuries Surveillance System (TTISS) – TTISS User’s Manual
- Standards for Blood Banks and Transfusion Services, 29th edition, 2014
- 7.4 Adverse Events Related to Transfusion
This information is being provided as guidance only. Hospitals should also refer to local reporting policies.
This Guide was developed by Canadian Blood Services Centre for Innovation Education Committee to facilitate the reporting of adverse transfusion events. For comments and suggestions, please contact us.