The Health Canada Blood Regulations came into force October 23, 2014. The "Blood Regulations" are only applicable to blood components, blood products are not in the scope of the Blood Regulations.
The BC transfusion technical community has developed tools to aid in some activities required by the Blood Regulations. The tools are provided in word format and can be editable for facility specific purposes.
| Adverse Recipient Reactions | |
| Refer to Job Aid: Transfusion Reaction Reporting to External Agencies | |
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An establishment (facility) that has reasonable grounds to believe that a recipient has experienced an unexpected adverse reaction or a serious adverse reaction that may be related to the safety of the component is subject to section 110 of the Blood Regulations. Communications and reports shall be documented using the BC Transfusion Reaction Reporting (TTISS) Form. |
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| Error and Accidents | Dated |
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Error and Accident Reporting Requirements The requirements for investigating and reporting errors and accidents apply to all establishments that handle blood for transfusion, including non-registered Transfusion Services. |
July 2023 |
| Health Canada Error or Accident Forms | Dated |
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Health Canada Blood Error or Accident Investigation Preliminary Report Form (FRM-0337) This form is primarily designed to facilitate the submission of preliminary reports to Health Canada within 24 hours after the start of an investigations. This form should not be used for the ongoing or final investigation reports where more detailed and comprehensive information are to be reported. |
May 2017 |
For additional information, please refer to the Health Canada Blood Regulations:
Canada Gazette Part ll, Vol.147, No.22 - SOR/DORS/2013-178 - Blood Regulations - pg 41- 106
Tip: for quick access to the Blood Regulations section, open the document and click on SOR/DORS/2013-178 on the left hand side Bookmarks.
