The Health Canada Blood Regulations come 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.

 

 Auditing Tool Dated

QS.HC.0001 Self Auditing Tool for Blood Regulations 

(Word / PDF)

Oct 2014
 Adverse Recipient Reactions
 

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)  

QS.HC.0008 Section 110 A Discovering Adverse Reaction
 Oct 2014
QS.HC.0009 Section 110 B Investigating Adverse Reaction  Oct 2014
QS.HC.0010 Section 113 Notice to the Minister  Jan 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  

QS.HC.0002 Section 103 The Notice to Notify

Oct 2014 

QS.HC.0003 Section 104 Establishment's Own Error or Accident

Oct 2014

QS.HC.0004 Section 105 Requirement to Cooperate

Oct 2014

QS.HC.0005 Section 106 Notice of Investigation of Results

Oct 2014

QS.HC.0006 Section 107 Reports to Minister

Oct 2014

QS.HC.0007 Section 108 Annual Report

Oct 2014
 Additional Templates  

QS.HC.0014 Section 96 Deviation Report

Nov 2014
 Health Canada Error or Accident Forms  

Health Canada Blood Error or Accident Investigation Preliminary Report Form (FRM-0337)

Oct 2014

 

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.

Health Canada - Guidance Document: Blood Regulations