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.
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May 2016 |
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| Adverse Recipient Reactions |
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| 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. Please note that the following templates will assist in providing additional documentation that may be required to meet the Blood Regulations requirements including: - Donation Codes of all implicated blood - Identify and quarantine any implicated blood in possession - Names of establishments or persons contacted (include dates, times and method of contact) |
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Oct 2014 |
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Oct 2014 |
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| QS.HC.0010 Section 113 Notice to Health Canada (Minister) | Apr 2017 |
| QS.HC.0011 Section 114 Results Notice | Oct 2014 |
| QS.HC.0012 Section 115 Final Report | Jan 2017 |
| QS.HC.0013 Section 116 Annual Report | Jan 2017 |
| Error and Accidents | |
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The requirements for investigating and reporting errors and accidents apply to all establishments that handle blood for transfusion, including non-registered Transfusion Services. |
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Oct 2014 |
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QS.HC.0003 Section 104 Establishment's Own Error or Accident |
Oct 2014 |
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Oct 2014 |
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Oct 2014 |
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QS.HC.0006 Section 107 Reports to Health Canada (Minister) All establishments are requested to provide error and accident reports and any information required under section 107 of the Blood Regulations to Health Canada by:
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April 2017 |
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Oct 2014 |
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| Additional Templates | |
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Nov 2014 |
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| Health Canada Error or Accident Forms | |
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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. This form is recommended for preliminary reports; other formats such as the one in the above table QS.HC.0006 Section 107 Report to Minister (Health Canada) is also acceptable. |
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.
