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Case Study 05 - Discussion Part 5 - Reporting Adverse Events
 

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Home Case Studies O-Level Case Study O5: Adverse event following plasma transfusion Case Study 05 - Discussion Part 5 - Reporting Adverse Events
Thursday, 27 April 2017

Case Study 05 - Discussion Part 5 - Reporting Adverse Events

This section will review standards and regulations for reporting transfusion complications. The discussion is not meant to be definitive or all inclusive.

Standards & Regulations

Standards and regulations exist for which transfusion-associated adverse events must be reported and to whom.

Canada

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
  • deaths
  • 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)

For an overview of Canadian hemovigilance systems and hospital guidelines for reporting adverse events, see

  • Public Health Agency of Canada. User's Manual Canadian Transfusion Adverse Event Reporting Form (April 2004) |

USA

In the USA, several agencies provide regulatory and quality oversight of transfusion medicine.

AABB www.aabb.org Joint Commission (formerly JCAHO) www.jointcommission.org
FDA www.fda.gov CAP www.cap.org
CBER www.fda.gov/cber FACT www.factwebsite.org

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

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.

Also see FDA. Guidance for Industry. Notifying FDA of Fatalities Related to Blood Collection or Transfusion

OTHERS

A selection of the status of adverse event reporting systems in other locations:

Europe

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. For an informative overview of regulated hemovigilance and notification, see

Down Under

This Case

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.

Learning Points

  • 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

*If you have comments on this section, please contact Pat: This e-mail address is being protected from spambots. You need JavaScript enabled to view it

TraQ self study questions

1. In Canada which three general categories of transfusion-related adverse events must be reported to the blood supplier or government regulator?

Answer

More Discussion...

Proceed to Case Summary

Further Reading

References

1. CSTM. Standards for Hospital Transfusion Services, v2

CSA. Blood and blood components (Z902-04). Mississauga, Ontario Canadian Standards Association, 2004.

Online resources

Australia: National Blood Authority

Canadian Blood Services: Investigation of transfusion reactions

EU directive and haemovigilance (Angela Robinson, UK NBS medical director)

European Haemovigilance Network

FDA. Guidance for Industry. Notifying FDA of Fatalities Related to Blood Collection or Transfusion

Public Health Agency of Canada. User's Manual. Canadian Transfusion Adverse Event Reporting Form (April 2004) | More...

UK: SHOT Program

Last modified on Wednesday, 06 April 2011 15:57