AprilMinutes of the eighteenth meeting of the Board of Directors of Héma-QuébecHeld at 3075 chemin des Quatre-Bourgeois, Suite 400, Sainte-Foy on Wednesday, April 5, 2000, at 2:00 p.m. (translation)
Present: Mr. Raymond April Dr. O'Donnell Bédard Mr. Robert Bédard Ms. Sheila Comerford Dr. Denis Cournoyer Dr. Francine Décary Dr. Réjean Paradis Mr. Claude Pichette Ms. Diane Roy (Observer, Chair of Hemovigilance Committee) Dr. Yves St-Pierre Ms. Cheryl Campbell Steer Absent: Dr. Louis R. Dufresne Dr. André Lebrun Guests: Dr. Georges Andreu Safety Committee member, Assistant Medical Director Établissement fran‚ais du sang Dr. Marc Germain Medical Director, Microbiology and Epidemiology, Héma-Québec Me Smaranda Ghibu Senior Director, Legal Affairs, Héma-Québec Me Véronique Girard Legal Counsel, Héma-Québec 1. Opening of meeting Claude Pichette chaired the meeting. He welcomed the members. Quorum being established, the meeting began at 2:10 p.m. 2. Adoption of agenda The agenda was read. It was proposed, duly seconded and unanimously resolved that the agenda be adopted with the following additions under "Miscellaneous": 11.1 Summary of Héma-Québec and Canadian Blood Services' management committee meeting on March 31, 2000 11.2 Joint meeting of the board of directors of Héma-Québec and Canadian Blood Services 11.3 Audit Committee meeting 3. Adoption of the minutes of the seventeenth meeting held on March 1, 2000 It was proposed, duly seconded and unanimously resolved that the minutes of the seventeenth meeting of the Board of Directors held on March 1, 2000, be adopted as submitted. 4. Business arising from the minutes of the seventeenth meeting 4.1 Procurement of blood components The Executive Director pointed out that the procurement of blood components is currently going very well. She postponed the submission of a recovery plan. 4.2 Follow-up - variant Creutzfeldt-Jakob disease in France The Assistant Medical Director of the Établissement fran‚ais du sang (hereafter referred to as "EFS"), who is a member of the Safety Committee, was invited to present France's position on variant Creutzfeldt-Jakob disease (vCJD) to the Board of Directors. To this day, two cases of vCJD have been confirmed in France. A third case is under investigation but still not confirmed. The Assistant Medical Director of the EFS presented data gathered by a committee of experts, of which he was a member, who were mandated to study the matter in France, especially with respect to the travel habits of French donors who visit the U.K. and the proportion of British beef consumed by the French between 1980 and 1996. He explained that on February 23, 2000, France's department of health decided, upon the recommendation of the group of experts, not to exclude donors who have sojourned in the U.K. The negative effects of this exclusion order would have been greater than the potential positive effects considering the exposure of the French to British beef in France. The Assistant Medical Director of the EFS pointed out that in the two confirmed cases in France as well as the third suspected case, the individuals had not travelled to the U.K. He explained that one of the measures taken by France's department of health was to adopt plasma leukoreduction to try to reduce the potential risk of transmitting the prion via blood. He recommended that the travelling habits of donors for all of Europe, not only France, be considered once a decision is to be taken on the exclusion criterion concerning vCJD in places other than the U.K. The decision should consider the degree of exposure of the French and other Europeans to U.K. beef. It was proposed, duly seconded and unanimously resolved that the Executive Director be mandated to submit options to the Board of Directors for excluding donors due to vCJD. (Action: F.D.) 4.3 Follow-up - Report on two audits by the Bureau of Biologics and Radiopharmaceuticals The Executive Director explained the corrections made to Héma-Québec's responses to the various observations in the Bureau of Biologics and Radiopharmaceuticals' audit reports following the January and February 2000 inspections, further to the suggestions of members at the March 1, 2000, Board of Directors meeting. 4.4 Research Ethics Committee The Executive Director invited the Senior Director, Legal Affairs, to give an update on this matter. The Senior Director, Legal Affairs, informed members that they still need a third specialist to complete the Research Ethics Committee. A name should be submitted to the Board of Directors at the next meeting. (Action: S.G.) Further to the resolution adopted during the March 1, 2000, meeting, an appointment confirmation letter shall be sent to each Research Ethics Committee member whose appointment has been approved. 4.5 Centre de conservation de tissus humains du Québec (CCTHQ; Québec Human Tissue Conservation Centre) The Executive Director recommended that the members first submit this matter to the Medical and Scientific Advisor Committee for further discussion at a future Board of Directors meeting. This recommendation was accepted. (Action: F.D.) 4.6 vCJD - Number of new donors since the implementation of the exclusion order The Executive Director presented data obtained on the percentage of new donors since the implementation of the exclusion order on September 30, 1999, for donors having sojourned in the U.K. New donors accounted for 21% between October 1999 and March 2000, compared to 15.2% between September 1998 and September 1999. 5. Claim report The Executive Director invited the Senior Director, Legal Affairs, to present this matter. The Senior Directo, Legal Affairs, presented the quarterly claim report for January 1 through March 31, 2000. 6. Jurisdiction of the human rights commission The Executive Director invited the Senior Director, Legal Affairs, to present this matter. As this is a legall matter, the discussion took place behind closed doors. 7. Preliminary report - Safety Committee The Executive Director notified members of the discussions that took place during the Safety Committee meeting held on April 4, 2000, in Québec City. The Safety Committee gave the following recommendation to the Board of Directors concerning Hepatitis B screening: The Safety Committee recognizes the potential residual risk of transmitting the Hepatitis B virus via blood transfusion. The Safety Committee therefore recommends that: - Héma-Québec make the implementation of a TAN VHB screening test a priority as soon as the technology is available.
In the meantime, Héma-Québec should assess the feasibility of choosing donors to make up an inventory of blood products from individuals who have been vaccinated against Hepatitis B. These products could be made available to immuno-compromised patients. If the recommended measure is feasible, it should then be adopted. The Executive Director explained that a donor survey will be undertaken to assess the feasibility of the interim measure. If possible, a question concerning vaccination against Hepatitis B shall be included in the donor questionnaire. (Action: F.D.) It was proposed, duly seconded and unanimously resolved that the Safety Committee's recommendation be adopted. 8. Serum bank: request from the administrator of the Hepatitis C victim compensation fund- 1986-1990 The Executive Director invited the Senior Directo, Legal Affairs, to present this matter. As this is a legall matter, the discussion took place behind closed doors. 9. Project follow-up The Executive Director gave an update on the implementation of various projects, in particular on the serum bank and variant Creutzfeldt-Jakob disease. 10. Board of Directors meeting on July 5, 2000 It was proposed, duly seconded and unanimously resolved that a Board of Directors meeting not be held on July 5, 2000, due to the summer vacation. 11. Miscellaneous 11.1 Summary of the March 31, 2000, meeting of Héma-Québec and Canadian Blood Services boards of directors The Executive Director gave an update on the March 31, 2000, meeting of the management committees of Héma-Québec and Canadian Blood Services. The goal of the meeting was to enable the two management committees to better get acquainted, to recognize their common mission to provide a safe and stable procurement of blood components for the whole country and to determine the fields in which both organizations may cooperate while respecting the various ways of doing things in order to attain the common objective. 11.2 Joint meeting of Héma-Québec and Canadian Blood Services boards of directors In view of the joint meeting of the boards of directors of Héma-Québec and Canadian Blood Services that will be held on June 20, 2000, in Ottawa, the Executive Director asked members about matters that should be added to the agenda. It was recommended that plasma self-sufficiency, research and development, and variant Creutzfeldt-Jakob disease be added to the agenda. 11.3 Report on the April 5, 2000, Audit Committee meeting The Audit Committee chair notified the Board of Directors that the first meeting was held earlier that day and that she will be submitting a draft of rules to the Audit Committee at the next meeting. 12. Next meeting The next meeting will be held on May 3, 2000, in the Boardroom at 4045 Cte-Vertu Boulevard, St-Laurent. 13. Adjournment It was unanimously resolved that the meeting be adjourned at 5:10 p.m. Mr. Claude Pichette Chair Dr. Francine Décary Secretary |