Draft Standards for Blood Safety

November 2002 - The Canadian Standards Association (CSA) draft Safety of Blood and Blood Components is still under development and subject to change. It has gone out for public review (second time). Please contact Jeffrey Kraegel at 1-416-747-2249 or write Canadian Standards Association, 5060 Spectrum Way, Mississauga ON, M9W 1R3 to request a copy.

April 2002 - This very comprehensive document is now with the Canadian Standards Association (CSA). Lorna Stevens was invited as an EWG member to join the CSA technical commitee on blood and blood components as a voting member. The purpose of this CSA initiative, sponsored by Health Canada, is to develop the EWG's draft standards blood safety into a national standard of Canada. The document will provide a commonly accepted set of rules for the management of blood and blood components which can be referrenced in legislation.

In November 1997, the Therapeutic Products Programme (TPP) of Health Canada established an Expert Working Group (EWG) at arm’s length from government, to develop a comprehensive safety standard for blood. This effort touched on several recommendations in Justice Horace Krevor’s Final Report of the Commission of Inquiry on the Blood System in Canada, namely:

"It is recommended that the Food and Drug Regulations be amended to contain regulations for the collection and processing of whole blood" and "In any National Blood System, the regulator must set minimum standards for all phases of the collection, processing and storage of blood..."

The EWG’s work on the safety standard has balanced the need to ensure optimal access for Canadians to safe blood with the need to allow for optimal blood transfusion practice.

The EWG has completed the first draft of the Standards for Blood Safety and as part of a continuing consultation process the standard has been circulated to stakeholders for comment (document is posted on the TPP website, www.hc-sc.gc.ca/hpb-dgps/therapeut). The EWG is reviewing the comments and the document will be revised as necessary. Once completed, it is proposed that the Standards for Blood Safety be referenced in regulations.

Expert Working Group Blood Standards

The Therapeutic Products Directorate’s Expert Working Group (EWG) on Blood Standards has been established to produce the proposed Standards for Blood Safety, a safety standard for blood.

The EWG will assist the Therapeutic Products Programme in subsequent refinements of the proposed Standards for Blood Safety. The EWG members have been appointed on the basis of their individual expertise, they do not represent firms, organizations or associations directly.

The following expert volunteers are current members of the EWG on Blood Standards:

Dr. Gilles Delage (Chair)
Scientific Director
Laboratoire de sante publique du Quebec
20045, chemin Ste. Marie ouest
Sainte-Anne de Bellevue, Quebec
H9X 3R5

Dr. John J. L. Freedman
Director of Transfusion Medicine
St. Michael’s Hospital
30 Bond Street
Toronto, Ontario
M5B 1W8

Ms. Rachel (Ray) Berger
Senior Advisor
Blood Advisory Group
805-110 Forward Avenue
Ottawa, Ontario
K1Y 4S9

Dr. Heather Hume
Hematology/Oncology
Hopital Ste. Justine
3175 Cote St. Catherine
Montreal, Quebec

Dr. Jo Anne Chiavetta
Director
National Epidemiology and Surveillance
Canadian Blood Services
Suite 1121, 790 Bay Street
Toronto, Ontario
M5G 1N9

Dr. James Robblee
Chief - Division of Anesthesia
University Ottawa Heart Institute
40 Ruskin Street
Ottawa, Ontario
K1Y 4W7

Dr. Francine Decary
Executive Director
Hema-Quebec
4045, boulevard Cote-Vertu
Saint-Laurent, Quebec
H4R 2W7

Lorna Stevens
President, Neutropenia Support Association Inc.
P.O.Box 243, 905 Corydon Ave.
Winnipeg, Manitoba
R3M 3S7

Ms. Lori Earl, B.N.
Patient Services Coordinator
Leukemia BMT Program CP E6
Vancouver General Hospital
855 W 12th Avenue
Vancouver, B.C.
V5Z 1M9

Executive Secretary:Peter Ganz (TPP)
Secretariat
: Mr. Greg Monsour (TPP)
Therapeutic Products Programme
Blood & Tissues Division
Tunney’s Pasture
AL: 0603C3
Ottawa, Ontario
K1A 0L2

***Lorna Stevens has attended all 21 meetings to date

For more information, vist the Canadian Blood Services web site.