March

Minutes of the twenty-eighth meeting

Held at 4045 Côte-Vertu Blvd., Saint-Laurent, in the Boardroom, on Wednesday, March 7, 2001, at 2:00 PM (translation)

Present :
Mr. Robert Bédard
Ms. Sheila Comerford
Dr. Francine Décary
Dr. Louis R. Dufresne
Dr. André Lebrun
Dr. Jean Montreuil
Dr. Réjean Paradis
Mr. Claude Pichette

Absent :
Mr. Raymond April
Dr. Denis Cournoyer
Ms. Diane Roy (Observer, Chair of Hemovigilance Committee)
Dr. Yves St-Pierre
Ms. Cheryl Campbell Steerr

Guests :
Me Smaranda Ghibu
General counsel
Mr. Guy Lafreni¾re
Senior Director, Administration and Finance
Héma-Québec

1. Opening of meeting
Claude Pichette chaired the meeting. He welcomed the members. Quorum being established, the meeting began at 2:05 PM.

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:

12.2 Access to information
12.3 Appointment of a new Hemovigilance Committee chairperson
12.4 Submission of the working group's final report on public participation presented to the Board of Directors of the Canadian Blood Services and response from the CBS concerning the working group's final report

3. Adoption of minutes of the twenty-seventh meeting held on January 31, 2000
It was proposed, duly seconded and unanimously resolved that the minutes of the twenty-seventh meeting of the Board of Directors held on January 31, 2001 be adopted as submitted.

4. Business arising from the minutes of the twenty-seventh meeting
4.1. SD plasma: Meeting with Health Canada and Canadian Plasma Products
Héma-Québec had requested a tripartite meeting to discuss methods for communicating serious reactions resulting from the administration of SD Plasma.

Health Canada representatives and the Executive Director of Héma-Québec will discuss this matter when they meet in Vancouver on March 29 for the National Blood Safety Council's public forum.
(Action: FD)

4.2. Response to the BBR's recommendations further to an inspection of the Québec City facility on December 4-8, 2000
The Executive Director presented the 16 observations made by the BBR further to their inspection of the Québec City facility, as well as Héma-Québec's response to those observations. The BBR's observations deal with good manufacturing practices, especially management of controlled documents, documentation and equipment maintenance. These observations do not compromise product safety. However, they require employees to be more aware of the importance of good manufacturing practices.

4.3. Response to the BBR's recommendations further to an inspection of the Montreal facility on January 31 to February 9, 2001
The Executive Director presented the 20 observations made by the BBR further to their inspection of the Montreal facility, as well as Héma-Québec's response to those observations. As for Québec City, these observations pertain to good manufacturing practices. These observations do not compromise product safety. Héma-Québec's establishment licence was renewed.

4.4. Nucleic acid amplification testing (NAT) for HIV: Health Canada authorization
Letters from Health Canada regarding the authorization to implement nucleic acid amplification testing for HIV at Héma-Québec and Roche Diagnostic (Canada) were submitted. HIV-NAT was implemented, under the research protocol, on January 17, 2001.

5. 2000-2001 Budget and follow-up
The Senior Director, Administration and Finance, presented the budget follow-up as at January 31, 2001. The follow-up indicates that we continued to run over budget in the past month. This is due to a 4.3% increase in the delivery of labile products with respect to the budget. This increase reflects the increased demand of hospitals. Consequently, blood collection has also risen. There is also a greater demand for stable products than planned for in the budget.

Moreover, the Executive Director and Senior Director, Administration and Finance, will meet with the Procurement and Financing Management Committee (PFMC) on April 5 to deal with the matter of billing hospitals for labile products.
(Action: FD/GL)

6. Resignation of Dr. Réjean Paradis
On February 8, the member representing public health submitted his resignation to the Board secretary. The resignation will come into effect August 1, 2001. The representative will pursue a career in the international health field. Members congratulated him and wished him much success in his new endeavour.

Dr. Paradis will remain on the Board of Directors until a replacement is appointed.

7. Recommendation of the Liaison Committee (December 2, 2000)
During the December 2, 2000 Liaison Committee meeting, the Committee reviewed the Hemovigilance Committee forum on informed consent, which was held on October 13, 2000.

As the Liaison Committee was not apprised of follow-up further to this forum, it expressed its concern. It therefore recommends that the Board of Directors follow up on its recommendation with the Hemovigilance Committee.

It was proposed, duly seconded and unanimously resolved that the resolution entitled "Héma-Québec's Liaison Committee's recommendation further to the Hemovigilance Committee's public forum held on October 13, 2000" be adopted, a copy of which is appended hereto.
(Action: FD)

8. Centre de conservation des tissus humains du Québec (CCTHQ; Québec Human Tissue Conservation Centre)
Further to the Board of Directors' June 7, 2000 resolution, the General counsel presented a draft joint venture between Héma-Québec and the CCTHQ to determine the desirability of integrating CCTHQ activities into Héma-Québec.

This contract defines the obligations and responsibilities of each party as well as the assessment mechanism for the pilot project. The General Counsel answers the members' questions on this matter.

As members were satisfied with the draft joint contract, it was proposed, duly seconded and unanimously resolved that the joint venture with the CCTHQ be concluded, and that the Executive Director be hereby authorized to sign the above-mentioned joint venture with any modifications to be made, at her own convenience, and to sign any other document and undertake any act she deems necessary or desirable, at her own discretion to give effect to this resolution, and to the conditions and commitments contained in the joint venture.The Executive Director's signature on the joint venture and on any other document shall constitute the irrevocable consent of Héma-Québec.

The Executive Director shall contact the CCTHQ to apprise them of the situation.
(Action: FD)

9. Safety Committee: appointment of new member
There is currently a vacant position on the Safety Advisory Committee. We recommend that this position be filled by Dr. Christopher Verrall Prowse of Scotland to retain international representation on this Committee.

It was proposed, duly seconded and unanimously resolved that Dr. Christopher Verrall Prowse be appointed member of the Safety Advisory Committee.
(Action: SG)

10. Joint meeting of the Héma-Québec and Canadian Blood Services boards of directors, May 2, 2001
The Executive Director met with the CEO of Canadian Blood Services to prepare the joint meeting of the boards of directors. They recommend a new format that allows for more interaction between board members. They suggest members discuss different topics in groups of eight then reconvene as a whole group.

The Executive Director asked members to submit topics for discussion. The following topics were noted:

• Intellectual property
• Informed consent
• Hospital billing

The Executive Director will submit these topics to the CEO of Canadian Blood Services.
(Action: FD)

11. Project follow-up
Nucleic acid amplification testing (NAT) for HIV:
Since the implementation of HIV-NAT testing on January 17, there has been no impact on the release time of labile products.

• vCJD - France
  Further to implementation of the exclusion measure last October 30 for donors who have stayed in France for more than six months, we noted an exclusion rate of 0.52% for 95,000 donors. Héma-Québec will shortly conduct a second survey on the habits of donors in Western Europe.
• Recertification for Good Manufacturing Practices/Good Work Practices (GMP-GWP)
  Employee training continues. This project is all the more important due to the type of observations made by the BBR.
• Invoicing
  The Executive Director and the Senior Director, Administration and Finance, will meet with PFMC members on April 5. Moreover, we will be presenting various invoice models to the Advisory Committee on Transfusion Medicine in Montréal and Québec City.
• Plasma self-sufficiency
  In anticipation of the National Blood Safety Advisory Board's public forum, Héma-Québec's and Canadian Blood Services' management committees will meet next week to discuss this matter.
• Negotiation of collective agreements
  Eight out of nine collective agreements were renewed to August 5, 2001. Consequently, there has been a salary adjustment for the affected employees. Moreover, joint labour relations committees have been created.
• Construction of laboratories
  Construction is proceeding on schedule.
• Statutory meetings with the CEO of Canadian Blood Services
  This month, the discussion was mainly focused on the joint meeting of management committees slated for the following week and the boards of directors meeting on May 2001.

12. Miscellaneous
12.1. January 26, 2001 letter to the deputy minister of Health and Social Services: Public Administration Act
Document submission.

12.2. Access to information
Further to the media coverage on the Access to Information Policy recently adopted by the Canadian Blood Services, the recipient representative questioned Héma-Québec's policy. The General Counsel informed members that Héma-Québec is a public organization that is subject to the Québec Act respecting Access to Information Held by Public Bodies and the Protection of Personal Information. This act promotes access to documents which are subject to a few specific exceptions.

12.3. Appointment of a new Hemovigilance Committee chairperson
Diane Roy has completed her term as chairperson of the Hemovigilance Committee. David Page was appointed the new chairperson of this committee.

12.4. Submission of the working group's final report on public participation to the Board of Directors of the Canadian Blood Services and response from the CBS concerning the working group's final report
Document submission.

12.5. Hemochromatosis
A transfusion medicine representative asked whether people with hemochromatosis could give blood. These donors are accepted for regular donations at 56-day intervals like regular donors, if they satisfy the selection criteria.

13. Next meeting
The next meeting will be held on Wednesday, April 4, 2001, at 2:00 PM at 4045 Cte-Vertu Blvd., Saint-Laurent, in the boardroom.

14. Adjournment
It was unanimously resolved that the meeting be adjourned at 5:05 PM.

Claude Pichette
Chair

Dr. Francine Décary
Secretary

RESOLUTION TO BE INTEGRATED INTO THE MINUTES OF THE HÉMA-QUÉBEC BOARD OF DIRECTORS MEETING OF MARCH 7, 2001
"Recommendation of the Héma-Québec Liaison Committee further to the Hemovigilance Committee's public forum on October 13, 2000"

WHEREAS the Hemovigilance Committee held a public forum on October 13, 2000, entitled "Information provided to patients who must receive blood or blood products and the relevancy of consenting to a transfusion;"

WHEREAS the four main topics discussed by speakers and attendees were: - Risks and benefits of transfusion; - Legal and ethical aspects of informed consent; - The perspective and experiences of users; - The perspective and experiences of physicians;

WHEREAS members of the Liaison Committee wish to follow up on the discussions that took place and the various consensus that emerged among the attendees, particularly: - The relevancy of obtaining free and informed consent before proceeding with a blood transfusion; - Taking the necessary means, investing financial resources and making information tools available to health professionals to allow them to explain to patients the risks and benefits of a blood or blood product transfusion;

WHEREAS the Liaison Committee is willing to cooperate with the Hemovigilance Committee, the Minister of Health and Social Services and various parties involved in the Québec blood system to follow up on the forum;

IT IS RESOLVED:

THAT the Hemovigilance Committee be asked to recommend to the Minister of State for Health and Social Services to take the necessary measures, invest sufficient financial resources and make information tools available to health professionals to allow them to explain to patients the risks and benefits of a blood or blood product transfusion;

THAT the Hemovigilance Committee and all parties involved in the Québec blood system be offered the cooperation of Héma-Québec's Liaison Committee to follow up on the discussions and consensus stemming from the Hemovigilance Committee's public forum.