This section will review standards and regulations for reporting transfusion complications. The discussion is not meant to be definitive or all inclusive.
Standards and regulations exist for which transfusion-associated adverse events must be reported and to whom.
In Canada both CSTM Standards and CSA Standard Z902-04 specify that serious adverse events must be reported immediately to the transfusion service.
Serious adverse events include (but are not limited to) 1 (CSTM N2.2):
- Immediate hemolytic reactions
- Delayed hemolysis
- Transfusion-related acute lung injury
- Systemic allergic reactions, including anaphylactic shock
- Bacterial sepsis
- Other transfusion-transmissible infections
- Transfusion-associated graft versus host disease
- Post-transfusion purpura
- Any adverse reactions that can be attributed to the quality of the blood and blood products must be reported to the blood supplier.1 (CSTM N2.4)
- All fatalities related to blood transfusion shall be reported to the blood supplier for reporting to Health Canada.1 (CSTM N2.5)
In the USA, several agencies provide regulatory and quality oversight of transfusion medicine.
Reporting requirements for adverse events are similar to those in Canada, for example, voluntary AABB Standards require that
Serious reactions be reported to the patient's physician and the transfusion service
Any adverse reactions that can be attributed to blood and blood products must be reported to the blood supplier
FDA current good manufacturing practices regulations for blood and blood components require reporting of fatalities related to blood collection or transfusion to the FDA.
FDA - CBER: 21 CFR 606.170(b) states:
- When a complication of blood collection or transfusion is confirmed to be fatal, the Director, Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research, shall be notified by telephone, facsimile, express mail, or electronically transmitted mail as soon as possible; a written report of the investigation shall be submitted to the Director, Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research, within 7 days after the fatality by the collecting facility in the event of a donor reaction, or by the facility that performed the compatibility tests in the event of a transfusion reaction.
A selection of the status of adverse event reporting systems in other locations:
Europe has an extensive International Haemovigilance Network, including the UK SHOT Program.
Individual countries have regulations and standards, as well as the EU blood Directive.
Australia.National Blood Authority
In this case the patient's transfusion complication was diagnosed as TACO secondary to plasma transfusion. Despite treatment, the patient went into cardiac arrest and died. TACO is not normally required to be externally reported but the patient's death makes it reportable to the blood supplier, who further reports deaths to Health Canada.
Standards and regulations exist for reporting transfusion-associated adverse events, and include reporting
serious reactions to the patient's physician and the transfusion service
adverse reactions attributed to blood and blood products to the blood supplier
transfusion-associated fatalities to the government regulator
1. In Canada which three general categories of transfusion-related adverse events must be reported to the blood supplier or government regulator?
- Part 1: Clinical uses of FFP
- Part 2. Compatibility requirements for plasma
- Part 3. Administering blood products
- Part 4: Investigating adverse events
- Part 5. Reporting adverse events <--You are here
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