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
 Presentations Dated

Health Canada Presentation

May 2016
 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.008 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 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  

The requirements for investigating and reporting errors and accidents apply to all establishments that handle blood for transfusion, including                     non-registered Transfusion Services.   

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 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:

  • Email: This email address is being protected from spambots. You need JavaScript enabled to view it. with the subject line “[Establishment Name] – Blood E/A Report” 
  • Or Fax: 613-960-2156  
April 2017

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)

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.  

April 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.

Health Canada - Guidance Document: Blood Regulations