A Guide to Reporting Adverse Transfusion Events (ATEs)
Why report ATEs? PATIENT SAFETY
Canadian Hemovigilance System consists of too federal regulatory agencies, each with a slightly different mandate, each contributing to safer transfusion practice ***UPDATE
Vanessa’s Law, implemented December 16, 2019 affects reporting of Plasma Derivative Manufacturers and REQUIRES reporting to these Plasma Derivative Manufacturers as well as DIRECTLY reporting to the Canada Vigilance Program at Health Canada.
PRODUCT QUALITY and ATEs: Canadian Hospitals are mandated to report serious or unexpected Adverse Recipient Adverse Reactions to Canadian Blood Services or Plasma Derivative Manufacturers, depending on the type of blood product transfused. Both of these manufacturers are regulated by the Canadian Vigilance Program (CVP) run by Health Canada (HC) and are focused on the safety of the blood product.
In rare cases, hospitals adverse transfusion reaction are to report directly to HC, if the transfusion medical laboratory (TML) did something that could have affected the product, such as “pooling” platelets, or leaving the product in an non working fridge. Reporting of Adverse Transfusion Events (ATEs) are indicated if the quality of the blood products are suspect.
INCIDENCE AND ATEs: The Transfusion Transmitted Injuries Surveillance System (TTISS) run by the Public Health Agency of Canada (PHAC) collects all moderate to severe transfusion reactions, regardless of the blood product being suspect, and includes transfusion reactions not mandated to be reported to CBS, PDMs, and/or HC. These include, acute hemolytic reactions due to wrong blood in tube, and Transfusion-associated Circulatory Overload (TACO). TTISS is able to monitor the frequency and incidence of adverse transfusion reactions. Minor reactions, such as delayed serological, febrile non-hemolytic and minor allergic reactions, although not mandatory, are encouraged to be reported.
To find out who to report to, download our Guide to Reporting Transfusion Reactions or answer these 4 easy questions on the Transfusion Reporting Decision Tool