April

Minutes of the seventh meeting of the Board of Directors of Héma-Québec

Held in the SSQ-Vie building in Quebec City, on Wednesday, April 7, 1999 at 2:30 p.m. (translation)

Present:
Mr. Raymond April
Dr. O'Donnell Bédard
Mr. Robert Bédard (Observer, Chairman of ABDV Board of Directors)
Ms. Sheila Comerford
Dr. Denis Cournoyer
Dr. Francine Décary
Dr. Louis R. Dufresne
Dr. André Lebrun
Dr. Réjean Paradis
Mr. Claude Pichette
Dr. Yves St-Pierre

Absent:
Ms. Diane Roy (Observer, Chairman of the Haemovigilance Committee)

Guests:
Me Smaranda Ghibu
Legal Counsel, Héma-Québec
Mr. Guy Lafreni¾re
Senior Director, Finance and Administration, Héma-Québec
Mr. Jean-Fran‚ois Lamarche
Senior Director, Public Relations, Héma-Québec

1. Opening of meeting
Claude Pichette chaired the meeting. He welcomed the members. Quorum being present, the meeting began at 2:30 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":

12.1 Advisory Committees to the Board of Directors
12.2 Board of Directors' meeting in July 1999
12.3 Joint meeting of the boards of directors of Canadian Blood Services and Héma-Québec/October 1999

3. Adoption of the minutes of the sixth meeting, March 3, 1999
It was proposed, duly seconded and unanimously resolved that the amended minutes of the sixth meeting of the Board of Directors held on March 3, 1999 be adopted.

4. Business arising from the minutes of the sixth meeting
4.1. nvCJD update
At its meeting on February 10, 1999, the Board of Directors adopted the principle of excluding donors who have sojourned in the United Kingdom. However, the Board recommended that management pursue its analysis of the nvCJD issue in order to determine the length of stay in the U.K. that would justify an exclusion of donors. The Board also asked management to consult the Safety Advisory Committee, the Haemovigilance Committee, CBS and the BBR. The Executive Director reported on the steps taken to date.

a) Safety Advisory Committee
Determining the length of stay in the U.K. that would justify donor exclusion was referred to the Safety Advisory Committee at its first meeting on March 9, 1999.
The Committee has not made any specific recommendations in this regard. It was suggested that Héma-Québec's actions be in line with those taken in Britain, which excludes British donors for fractionated products but accepts them for labile products. This approach was adopted in order to avoid the amplification impact of exposure to a donor involved in the pool preparation of fractionated products if it is ever determined that nvCJD is a blood-borne disease.
The Committee also discussed the impact which an isolated decision might have. It concluded that it would be difficult to decide on the exclusion of plasma donors who have sojourned in the United Kingdom without the involvement of Canadian Blood Services, since the plasma from both agencies is used for the production of the same product batches.

b) Haemovigilance Committee
At its meeting on March 11, 1999, the Haemovigilance Committee expressed support for the nvCJD decisions reached by the Board of Directors of Héma-Québec on March 3, 1999. The Committee favours the different approach to plasma and labile products. It is also the Committee's opinion that discussions should take place with the other stakeholders in the system.
The Executive Director advised the Board of Directors that, according to an article dated March 2, 1999 and published in the March 20, 1999 edition of "Lancet," 39 deaths caused by the nvCJD were reported to the National CJD Surveillance Unit, of which 9 cases were reported in the final quarter of 1998. This new information was taken into account by the Board.

Following a lengthy discussion, it was proposed, duly seconded and resolved by a majority vote to adopt the "New Variant of Creutzfeldt-Jakob Disease" resolution, a copy of which is attached to these minutes. Two abstentions were recorded with respect to the length of stay justifying donor exclusion for labile products.

c) Canadian Blood Services
Executives from Héma-Québec and Canadian Blood Services frequently contacted each other in March on the subject of nvCJD. At her last meeting with the Chief Executive Officer of Canadian Blood Services, the Héma-Québec Executive Director conveyed Héma-Québec's position on this matter. The Héma-Québec Executive Director told her counterpart that the decisions of the Board of Directors made on April 7, 1999 would be forwarded to her as soon as possible. The Executive Director indicated that the BBR would also be informed of the decisions reached by the Board on April 7, 1999. It was noted that the issue of the new variant of Creutzfeldt-Jakob disease would be the subject of discussion at the upcoming public meeting of the National Blood Safety Council scheduled for May 6 and 7, 1999.
(Action: F.D., S.C., R.P., R.B.)

4.2. Liaison Committee
The Executive Director and the recipients' representative informed the Board of Directors that eight (8) of the ten (10) positions on the Liaison Committee had been filled. A list of the members and a draft agenda for the meeting scheduled for May 20, 1999 were distributed to the Board members.

4.3. Web site
The minutes of all Board of Directors' meetings held since October 7, 1998 will soon be posted on Héma-Québec's Web site.

4.4. Reply to Assistant Deputy Minister, Public Health Branch
The Executive Director apprised the members of the comments she forwarded to the Assistant Deputy Minister of Public Health concerning the reorganization of the Québec blood system. She thanked the Board members who provided her with their comments.

4.5. Termination of contract with NGI
The Executive Director outlined the history of this matter. In March 1998, the Canadian Red Cross signed an agreement with NGI, a company based in Los Angeles, for PCR tests (nucleic acid testing).

The NGI contract was assigned to Héma-Québec and Canadian Blood Services as part of the transfer of the blood supply system. However, NGI's services cannot meet Héma-Québec's operational requirements, in particular because the distance between the two agencies prevents the test results from being forwarded to Héma-Québec quickly enough for the timely distribution of platelet concentrates.

The Senior Director, Finance and Administration presented and discussed the options available for financing the cost of terminating the contract.

It was proposed, duly seconded and unanimously resolved that the "Termination of contract with NGI" resolution, a copy of which is attached hereto, be adopted as presented.
(Action: G.L.)

4.6. Contract with Infectio Diagnostic Inc.
European countries are preparing to introduce nucleic acid amplification tests (NAT) on July 1, 1999 as a general blood safety improvement against the hepatitis C virus and in order to meet the requirements of regulatory agencies whereby the plasma used in the manufacture of fractionated products must be declared free from HCV on the basis of an NAT.

The United States was compelled to do likewise since a large portion of the plasma collected in the U.S. is exported to Europe in the form of fractionated products. AMCROSS and American Blood Centers will have NAT available for HCV this summer, most probably in July.

In October 1998, Héma-Québec announced to the BBR its intention to take similar steps and implement NAT against hepatitis C in July.

Héma-Québec could either conduct the NAT itself or resort to outsourcing. Given that Héma-Québec does not have the staff, expertise and physical space needed to conduct NAT internally, nor could it do so within the timetable adopted by institutions in the U.S. and Europe, it was recommended that this work be outsourced.

Moreover, it was recommended that the tests be outsourced to Infectio Diagnostic Inc. (IDI), which is based in Ste-Foy. Based on a market study, IDI is the only company located within an acceptable distance that can deliver the services needed on time.

It was proposed, duly seconded and unanimously resolved that the "Contract with Infectio Diagnostic Inc." resolution, a copy of which is attached hereto, be adopted as presented.
(Action: G.L.)

5. Recommendations 11 to 50 from the final Krever report
This item will be discussed at the next meeting.

6. Finance
6.1. Three-year forecasts
The Senior Director, Finance and Administration presented the three-year budgetary forecasts (1999-2000). They include substantial increases due in part to the blood safety improvements expected in the coming years such as:

• Plateletpheresis instead of platelet pools (Benefit: exposure to fewer donors).
• Self-sufficiency in plasma (Krever recommendation #25).
• Implementation of prion testing (lower risk of spongiform encephalopathy).
• Quality control for the presence of bacteria in each platelet concentrate and packed red blood cell units (reduction in post-transfusional bacterial infections).
• Artificial blood for traumas (improved safety and lack of blood types).
• Viral inactivation process for cell components.

It was proposed, duly seconded and unanimously resolved that the budgetary forecasts be adopted as presented.

In accordance with section 29 of An Act respecting Héma-Québec and the haemovigilance committee, the forecasts must be forwarded to the Minister of Health and Social Services.

6.2. Financial resources policies
The Senior Director, Finance and Administration reviewed the policies pertaining to investments, hedging against currency fluctuations and short-term investments. These policies are intended to give Héma-Québec a management framework for investment projects, foreign currency fluctuations and target returns on surplus cash at no risk.

It was proposed, duly seconded and unanimously resolved that the following resolutions be adopted as presented: "Investment Policy," Currency Hedging Policy" and "Short-term Investment Policy."

6.3. Awarding a contract for reparing the ventilation, air conditioning and heating systems at 4045 Cte-Vertu, and report from the selection committee
The Senior Director, Finance and Administration presented the tender selected by the Héma-Québec committee.

It was proposed, duly seconded and unanimously resolved that the "Reparing the ventilation, air conditioning and heating systems at 4045 Côte-Vertu" resolution, a copy of which is attached hereto, be adopted.

7. Year 2000
The Senior Director, Finance and Administration reviewed the Y2K compliance issue. Héma-Québec has set up a committee made up of representatives from all the departments involved.

The implementation of MAK-SYSTEM's PROGESA software is scheduled for November 5, 1999 and is on schedule; the implementation of SAP was completed on April 6, 1999.

An inventory of all Héma-Québec equipment is completed, and analyses and conversions have begun. Follow-up on the steps taken by the committee will be provided at all Board meetings.

8. Personal responsibility of the administrators of public health establishments
This item will be discussed at the next meeting.

9. Communications plan
The Senior Director, Public Relations presented the 1999-2000 communications plan. It will focus as much on internal as on external communications and be guided by the following principles:

• Héma-Québec is an organization geared towards the needs of patients.
• Product safety is at the heart of Héma-Québec's activities.
• Héma-Québec is a transparent organization.
• Héma-Québec's public image is in keeping with its internal operations.
• All communications activities (except in crisis situations) are linked to each other and are part of a whole. Each helps the subsequent activity move forward or is in preparation for it.
• Héma-Québec must be able to measure the impact of its communications on target audiences.

Measurement criteria have been adopted to determine the plan's effectiveness in the long term.

As well, the effectiveness of Héma-Québec's television campaign was discussed. The members asked that an assessment be conducted to determine whether the end of the advertising campaign had an impact on the blood supply.

10. Update on current projects
The Executive Director distributed a current project chart and commented on progress.

11. Inspection visit by the Bureau of Biologics and Radiopharmaceuticals (BBR), March 23-26, 1999
The BBR conducted its annual inspection of the Montréal establishment from March 23 to 26, 1999. It noted 14 procedural items that have no impact on the safety of the blood supply. The inspection report will be publicly released on April 19, 1999 and will be posted on the Web site.

12. Miscellaneous
12.1. Board of Directors' Advisory Committees
This item will be discussed at the next meeting.
(Action: F.D.)

12.2. Board of Directors' meeting in July 1999
The Board of Directors will be meeting on July 7, 1999 as scheduled.

12.3. Joint meeting of the boards of directors of Canadian Blood Services and Héma-Québec in October 1999
Further to the decision made by the Board in March 1999, it was suggested that the next meeting be held on October 13, 1999 in Montréal. The members accepted the suggestion, and they were invited to propose items for the meeting's agenda.
(Action: All)

12.4. Election of the donor and volunteer representative as Chairman of the Association of Blood Donation Volunteers ("ABDV")
The Chairman congratulated the donor and volunteer representative (Robert Bédard), who was elected Chairman of the ABDV on March 16, 1999 when the Association's board of directors was formed. The ABDV will recommend that the Minister of Health and Social Services appoint the ABDV Chairman to the Board of Directors of Héma-Québec as the representative of blood donors and volunteer blood drive organizers.

A congratulatory motion was unanimously adopted.

12.5. Congratulations to Jean-Guy Lorrain, assistant to the Executive Director
The Executive Director highlighted the significant contribution made by Jean-Guy Lorrain, who assisted her in setting up Héma-Québec and the ABDV. He will return to his consulting work on April 30, 1999.

A motion of appreciation was unanimously adopted.

13. Next meeting
The next meeting will be held on May 12, 1999 at 2:00 p.m. at the Hilton Hotel located at 12505 Cte de Liesse in Dorval.

14. Adjournment
It was unanimously resolved that the meeting be adjourned at 8:10 p.m.

Mr. Claude Pichette
Chairman

Dr. Francine Décary
Secretary

RÉSOLUTION THAT FORMS PART OF THE MINUTES OF THE HÉMA-QUÉBEC BOARD OF DIRECTORS' MEETING HELD ON APRIL 7, 1999
"New variant of Creutzfeldt-Jakob disease"

WHEREAS, during its last meeting on March 3, 1999, the Board of Directors adopted the principle of excluding donors who have sojourned in an nvCJD-risk zone, due to the risk, however small and "theoretical," that the nvCJD represents for Québec's blood supply;

WHEREAS, during this meeting, the Board of Directors was not able to determine the length of stay that would justify the exclusion of donors and recommended that the analysis of the nvCJD matter be pursued by management and that consultations be carried out with the Risk Management Committee, the Haemovigilance Committee, CBS and BBR;

WHEREAS, according to the donor survey, 3% of donors have spent more than one month, consecutively or cumulatively, in the U.K.;

WHEREAS Héma-Québec can exclude up to 3% of its donors without endangering the blood supply in Québec;

WHEREAS, with the exception of the BBR, Héma-Québec's management has once consulted the stakeholders mentioned above;

WHEREAS the Risk Management Committee suggested treating fractionated products differently than labile products;

WHEREAS the Haemovigilance Committee supported the decisions made by Héma-Québec's Board of Directors on March 3, 1999, and encourages different approaches for plasma and labile products;

WHEREAS Canadian Blood Services was informed of Héma-Québec's decision in this matter;

WHEREAS Héma-Québec's Board of Directors considers that a decision must be made as soon as possible with respect to the exclusion of donors who have sojourned in the U.K.;

IT IS RESOLVED:

THAT Héma-Québec favors, in the name of caution, the following exclusions:

1. all plasma, to be used in fractionated products, from donors who have sojourned in the U.K., for any length of time, since 1980;
2. all labile product donations from donors who have sojourned in the U.K. for one (1) month or more since 1980, consecutively or cumulatively;

THAT the management of Héma-Québec present the organization's position to CBS and to the BBR and submit a report at the next meeting of the Board of Directors.

RESOLUTION THAT FORMS PART OF THE MINUTES OF THE HÉMA-QUÉBEC BOARD OF DIRECTORS' MEETING HELD ON APRIL 7, 1999
"Termination of contract with the National Genetics Institute"

WHEREAS the contract between the Canadian Red Cross and the National Genetics Institute (NGI) was assigned to Héma-Québec on August 26, 1998;

WHEREAS the services offered by NGI cannot meet Héma-Québec's operational requirements, especially since the distance between the two organizations prevents test results from being forwarded to Héma-Québec in a timely manner;

WHEREAS the financing options related to the costs of terminating the contract with NGI were presented to the Board of Directors;

IT IS RESOLVED:

TO TERMINATE the contrat with NGI;

THAT management negotiate the costs related to this termination;

THAT the outcome of these negotiations be presented to the Board of Directors for approval;

THAT Héma-Québec finance itself the costs related to the termination of the contract with NGI.

RESOLUTION THAT FORMS PART OF THE MINUTES OF THE HÉMA-QUÉBEC BOARD OF DIRECTORS' MEETING HELD ON APRIL 7, 1999
"Contract with Infectio Diagnostic Inc."

WHEREAS Héma-Québec wishes to implement the screening of donor blood for the hepatitis C virus using nucleic acid amplification tests ("NAT");

WHEREAS the use of NAT should be implemented in Québec at the same time as in the U.S. and in Europe;

WHEREAS Héma-Québec does not currently have the necessary personnel, expertise and facilities to carry out NAT;

WHEREAS Infectio Diagnostic Inc. ("IDI") is the only company currently able to carry out NAT on blood donors for the following reasons:

1. IDI meets the Good Manufacturing Practices (GMPs) standards demanded by the BBR and Héma-Québec with respect to the blood supply;
2. IDI has the necessary expertise to implement the use of NAT given that these tests are an integral part of its mission;
3. IDI can accommodate Héma-Québec's donation volume, namely more that 1,000 tests per day, and can guarantee the results in 24 hours;
4. Héma-Québec has ensured that the GMPs are followed and that IDI respects the required standards;
5. Roche Diagnostics, which manufactures the NAT kits to be used by IDI, also carried out an inspection of IDI laboratories and is satisfied that GMPs are followed;
6. No other company or organization in Québec currently meets these standards;
   6.1 The NAT used in hospitals are diagnostic and not screening tests;
   6.2 Universities or research centres use NAT in a research context that is not governed by GMPs or subject to high-volume testing;
   6.3 Service laboratories are not equipped for high-volume molecular biology;
   6.4 This direct screening function is not part of the mandate of the Laboratoire de santé publique du Québec (LSPQ);
7. IDI is a small enterprise. Héma-Québec has very easy access to management, which is closely involved in the company's activities;
8. Héma-Québec has been able to ascertain the expertise of the IDI team members;
9. Héma-Québec has been familiar with IDI for over a year since both organizations collaborate on a project for the detection of bacteria in platelet concentrates;

IT IS RESOLVED:

TO OUTSOURCE NAT to IDI for a specified period of time;

TO AUTHORIZE the Executive Director to sign an agreement in principle with Infectio Diagnostic Inc. and to undertake the negotiation of terms and conditions for an NAT service contract

RESOLUTION THAT FORMS PART OF THE MINUTES OF THE HÉMA-QUÉBEC BOARD OF DIRECTORS' MEETING HELD ON APRIL 7, 1999
"Reparing the ventilation, air conditioning and heating systems at 4045 Côte-Vertu"

WHEREAS it is necessary to retrofit the ventilation, air conditioning and heating systems at 4045 Côte-Vertu in Saint-Laurent;

WHEREAS Héma-Québec conducted a call for tenders without quotes in accordance with the guidelines established by the Treasury Board;

WHEREAS the selection committee, following a review of the tenders received, recommended that the contract for reparing the ventilation, air conditioning and heating systems be awarded to Groupe HBA;

WHEREAS the work will cost an estimated $765,000 ($665,000 excluding GST/QST) according to the payment-of-fee methods provided for under the Treasury Board guidelines;

WHEREAS the amount of $765,000 was included in Héma-Québec's start-up/capitalization budget and approved by Treasury Board;

IT IS RESOLVED:

THAT Héma-Québec award the contract for reparing the ventilation, air conditioning and heating systems to Groupe HBA in consideration for an amount not exceeding $765,000 ($665,000 excluding GST/QST);

THAT the Executive Director be and is hereby authorized to sign the reparing contract mentioned above, including any amendments that might be made thereto, as she deems appropriate, and to sign any other document and to take any other step which, at her sole discretion, she might deem necessary or desirable, to give effect to the present resolution and to the terms, conditions and undertakings contained in the said contract and documents, and that the Executive Director's signature on the contract for reparing the ventilation, air conditioning and heating systems and any other similar document be irrefutable evidence that Héma-Québec has approved the signing of such documents.