June

Minutes of the fortieth meeting

Held at 4045 Côte-Vertu Blvd, Saint-Laurent, in the Boardroom, on Wednesday, June 19, 2002, at 2:00 PM

Present:
Mr. Raymond April
Mr. Robert Bédard
Ms. Sheila Comerford
Dr. Denis Cournoyer
Dr. Francine Décary
Dr. Marc Dionne
Dr. André Lebrun
Dr. Jean Montreuil
Mr. Claude Pichette
Dr. Lucie Poitras
Ms. Cheryl Campbell Steer
Dr. Yves St-Pierre

Hemovigilance Committee observer:
Mr. Jean-Guy Lorrain

Guests:
Me Smaranda Ghibu, General Counsel
Mr. Guy Lafrenière, Senior Director, Finance and Administration
Ms. Suzanne Poirier, Meeting Delegate
Héma-Québec

1. Welcome to new members
The meeting chairperson welcomed the new members who were appointed on May 7, 2002. Dr. Marc Dionne will be the public health representative and Dr. Lucie Poitras will represent hospitals. The existing Board members took turns introducing themselves to the new members.

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

3. Adoption of agenda
It was proposed, duly seconded and unanimously resolved that the agenda be adopted, with the following modifications:
16.4 Public Héma-Québec meeting of September 18, 2002;
16.5 National Blood Safety Council meeting of September 12 and 13, 2002;
16.6 Recommendations of Hemovigilance Committee;
16.7 Joint meeting of the boards of directors of the Canadian Blood Services and Héma-Québec;
16.8 Summary of the International Federation of Blood Donor Organizations Conference held from May 22 to 26, 2002;
16.9 Summary of Scientific and Medical Advisory Committee meeting held on May 16, 2002;
16.10 Recognition of Dr. Louis Dufresne's work on the Board.

4. Adoption of the minutes of the thirty-ninth meeting held on March 6, 2002
It was proposed, duly seconded and unanimously resolved that the minutes of the thirty-ninth meeting of the Board of Directors held on March 6, 2002, be adopted with the requested corrections.

5. Business arising from the minutes of the thirty-ninth meeting
5.1. Appointments to Héma-Québec Executive Committee

Pursuant to Héma-Québec's by laws, the Executive Committee must comprise at least five administrators selected from the members of the Héma-Québec Board of Directors. There are currently two vacant positions following the departure of Drs. Paradis and Dufresne.

The Chairperson appointed Mr. Raymond April and Dr. Yves St-Pierre as members of the Executive Committee until expiry of their mandate as Board administrators.

It was proposed, duly seconded and unanimously resolved that Mr. Raymond April and Dr. Yves St-Pierre be appointed members of the Executive Committee until expiry of their mandate as Board administrators. Henceforth, the Executive Committee will be comprised of the following five members:

  • Mr. Raymond April
  • Dr. Francine Décary
  • Dr. André Lebrun
  • Mr. Claude Pichette
  • Dr. Yves St-Pierre

5.2. Financing for new building at 4045 Côte-Vertu Blvd.
The Senior Director, Finance and Administration joined the meeting.

At the Board meeting of March 6, 2002, the members asked the Finance Department to assess the feasibility of financing the new building through a long-term variable-rate loan that can be transferred to a swap agreement in a short time, subject to the Board's conditions.

The Senior Director, Finance and Administration indicated that Héma-Québec Finance Department has determined that the conditions set out by the Board on March 6, 2002 cannot be met.

Further to these observations, the Finance Department conducted a comparative analysis of the financing costs for both types of mortgage: mortgage with variable repayments (fixed capital amount) versus a mortgage with fixed repayments (variable capital amount), for a 25-year amortization. Considering the results of the analysis, a 25-year mortgage with variable repayments over a 7-year term was selected.

This point was also presented to the members of the Audit Committee on June 13, 2002, who supported the Finance Department's decision. The members declared themselves satisfied with the information and supported the Finance Department's decision.

6. Adoption of Héma-Québec's financial statements for 2001-2002 and the management report to March 31, 2002
The members of the Board read a letter dated June 7, 2002 from the Minister of State for Health and Social Services conforming the commitment of credits corresponding to Héma-Québec's general budget for 2002-2003 in the order of $249,070,500.

Management report to March 31, 2002
The Senior Director, Finance and Administration commented on the management report to March 31, 2002.

The financial statements to March 31, 2002 were presented. The revised amount for projection of the 2001-2002 results to the Board of Directors at November 7, 2001, was $206,751,500 and the 2001-2002 financial year ended with $203,519,978 - a reduction of $3,321,522 compared with the anticipated amount. Compared to the 2001/2002 budget approved by the MHSS, labile products resulted in savings of $2,756,200.

The Senior Director, Finance and Administration presented the 2001-2002 budget figures for stable and labile products and commented on the budget comparisons by main category as well as charges by responsibility centre for labile and stable products. The data on new capital acquisitions for 2001-2002 was also presented. Lastly, a table showing the liquidity position for 2001-2002 was submitted to the members of the Board. Héma-Québec maintains a positive cash position.

In response to a request by a Board Member, the cost breakdown substantiating the increase in 2000-2001 and 2001-2002 will be presented at a future Board meeting.

Financial statements as at March 31, 2002
The Senior Director, Finance and Administration presented the financial statements.

The Audit Committee Chairperson stated that the Committee reviewed Héma-Québec's financial statements at its meeting held on June 13, 2002. The members of the Audit Committee recommended that the Board of Directors adopt Héma-Québec's financial statements as submitted. The Auditor General issued an unqualified opinion for the period ended March 31, 2002 and praised the outstanding cooperation of the Finance and Administration team.

The Audit Committee met with representatives of the Auditor General to obtain their observations regarding the annual audit.

The four observations from last year have been dealt with to the Auditor General's satisfaction. One observation was made for 2001-2002 concerning the manner in which foreign currencies are translated in the SAP program. This situation will be rectified in fall 2002 when SAP version 4.6 is implemented. This new version comprises a multi-currency function. The Auditor General made no observations in his report which will be submitted to the Québec National Assembly on June 30, 2002.

The members of the Board of Directors indicated that they were satisfied with the presentation and congratulated the Senior Director, Finance and Administration, as well as the members of his team, for the work done in preparing the financial statements.

It was proposed, duly seconded and unanimously resolved that the Héma-Québec financial statements for the period ended March 31, 2002 be adopted.

It was proposed, duly seconded and unanimously resolved that Claude Pichette and Cheryl Campbell-Steer be designated signatories of the Héma-Québec financial statements for the period ended March 31, 2002.

In closing, the Senior Director, Finance and Administration indicated that he would present a comparison of the financial statements of the Canadian Blood Services (CBS) and of Héma-Québec, as he did last year.

Audit Committee of June 13, 2002
The Audit Committee Chairperson discussed certain points raised by the Audit Committee: Héma-Québec's general by laws require that professional services contracts in excess of $100,000 be approved by the Board of Directors. The Audit Committee will be informed of any contracts of this type as well as any cost overruns or overruns that would lead to a professional services contract that exceeds $100,000. The Audit Committee Chairperson will gather the necessary data required for Board approval.

A request to increase the capitalization threshold for capital expenditures has been submitted to the Audit Committee. The purpose of this request is to streamline the administration of administrative order DRF005 Politique d'investissement (acquisition d'immobilisation) [investment procedure (capital acquisitions)] by increasing the capital expenditure threshold by $1,000 to $2,500.

Whereas the members of the Audit Committee recommend increasing the capital expenditure threshold to $2,500, it was proposed, duly seconded and unanimously resolved that the Audit Committee's recommendation be approved, and the capital expenditure threshold be increased to $2,500.

She added that the Audit Committee would be meeting on September 18, 2002 to examine the main budget assumptions to develop the 2003-2004 budget.

7. Observation of the Auditor General
The Chairperson of the Audit Committee indicated that only one observation (described previously) had been made by the Auditor General during their meeting of June 13, 2002. However, this observation will not be noted in the Auditor General's report to the National Assembly.

8. Increase in borrowing threshold with Royal Bank: Evergreen program
The Audit Committee Chairperson said that the Committee has looked into increasing the borrowing threshold for the Royal Bank's Evergreen program. The Royal Bank's program has been in the credit facilities placed at Héma-Québec's disposal (categories 6 and 7).

Given recent the investments and future capital acquisition forecasts, an increase in the borrowing threshold would be required. The Financial Department has therefore submitted the following proposal:

The borrowing threshold for category 6 (call loan for interim capital financing) remains unchanged, i.e., $2,000,000 while the borrowing threshold for category 7 (term capital financing in the form of a revolving term loan) would be increased from $11,000,000 to $15,000,000, the total of which may not exceed $16,000,000.

Further to the recommendation of the members of the Audit Committee to increase the total borrowing threshold of the Royal Bank's Evergreen program from $12,000,000 to $16,000,000, it is proposed, duly seconded and unanimously resolved that approval be given to increase the total borrowing threshold of the Royal Bank's Evergreen program from $12,000,000 to $16,000,000. A request from the Financial Department will be prepared and sent to the Royal Bank.

It is proposed, duly seconded and unanimously resolved that the Senior Director, Finance and Administration be authorized to sign all contracts, and take at his sole discretion any other actions he deems necessary or desirable to give effect to this resolution.

9. Stable products call for tenders
9.1. List of contracts to grant
9.2. Executive Committee meeting of May 21, 2002: submission of minutes

In response to a recommendation of the Board of Directors dated June 27, 2001, Héma-Québec participated in the tendering process launched by the CBS in September 2001. The call for tenders covers contracts for stable products as of April 1, 2003.

Regarding contracts for fractionation services and commercial recombinant products, on May 21, 2002, the Héma-Québec Executive Committee approved the Management Committee's recommendation to approve the following CBS decision:

  • Two-year fractionation services contract with Bayer
  • Two-year commercial IVIg contracts with Bayer and Baxter
  • Bayer Gammimune - 70%
  • Baxter Gammaguard - 13%
  • (Canadian plasma - 17%)
  • Three-year contracts for commercial recombinant products with Bayer and Baxter
  • Bayer FS Kogenate - 55%
  • Baxter Recombinate - 45 %

These figures represent proportions for Canada and do not include sharing between CBS and Héma-Québec.

In the event there is a price increase deemed unreasonable during the negotiations, Héma-Québec will refer to the Board of Directors for approval.

Certain questions were raised concerning recovery of plasma intermediates after fractionation. It will be necessary to assess the use of these intermediates.

Stable Products Information System (SPIS)
On February 6, 2002, the members of the Board adopted a resolution authorizing the implementation of a SPIS at a cost $758,000 to manage stable products.

Several factors were not taken into consideration during the initial cost assessment, which is why the project cost went from $758,000 to $1,224,000.

During the meetings of June 13 and 19, 2002, the members of the Audit Committee examined the causes of this increase. The cost overrun was primarily due to the following reasons:

  • First implementation of IT projects management framework
  • Complexity of the solution, realization and process effort
  • Addition of two modules
  • Regulated environment
  • Multitude of concurrent projects required Héma-Québec to use the resources in place, thus requiring hiring of outside resources

The members of the Audit Committee have also requested a more detailed table comparing the cost of repatriation versus the costs charged by the Canadian Blood Services (CBS) for purposes of analysis. The numbers showed that, despite the cost increase, Héma-Québec would achieve savings of $870,000 per year. Repatriating management of stable products would be cost effective for Héma-Québec and bring about a return on investment after 1.4 years.

Following an exhaustive analysis of this file, the Audit Committee recommended that the Board of Directors approve this cost increase.

In light of the information obtained and in view of the Audit Committee's recommendation to approve this new increase, it is proposed, duly seconded and unanimously resolved that the new cost increase for implementation of the SPIS software ? bringing the total project cost to $1,224,000 ? be approved.

9.3. Letter to the National Public Health Director
The members read a letter from the National Public Health Director dated May 21, 2002 designating Héma-Québec as the sole signatory for stable products supply contracts pending regionalization of hospitals' blood budgets.

10. Centre de conservation des tissus humains du Québec
The Senior Director, Finance and Administration presented the 2002-2003 operating and capital budget for the Québec Human Tissue Conservation Centre (CCTHQ; Centre de conservation des tissus humains du Québec). Income was $614,414 and expenses totalled $748,858 - a deficit of $134,444. The detailed 2002-2003 capital budget was also submitted.

It was proposed, duly seconded and unanimously resolved that the 2002 -2003 budget be approved.

The Senior Director, Finance and Administration left the meeting.

The position of Senior Director for the tissue centre will have to be filled. This position is currently being filled on an interim basis by the Executive Director of Héma-Québec.

The Executive Director will submit the CCTHQ business plan for the next meeting of the Board of Directors. Once the business plan has received Board approval, it will be submitted to the Ministère de la Santé et des Services sociaux (MSSS: Department of Health and Social Services).

Given that Héma-Québec's mandate has been expanded to include distribution of human tissue, the members will look into the associated risks. The Executive Director indicated that the Héma-Québec safety rules applicable for blood are similar to the rules governing human tissue.

In closing, she added that obtaining American Association of Tissue Banks accreditation for Héma-Québec remains a priority.

The public health representative indicated that the report ordered by the MSSS comprising several recommendations concerning tissue banks had recently been submitted to the Institut national de la santé publique du Québec (Québec Public Health Institute). As soon as it has been made public, it will be submitted to the Board of Directors for information purposes.

11. Cord blood bank
The Executive Director presented the national cord blood bank pilot project. This project is being carried out by Hôpital Sainte-Justine, Centre hospitalier universitaire Mère-Enfant and Héma-Québec in collaboration with St. Mary's Hospital.

Given the limitations of voluntary marrow donor registries due to:

  • Ethnic representation
  • Time limits
  • Attrition
  • An in view of the significant benefits offered by cord blood due to the malleability of cord blood cells, as well as
  • Immunologic latitude
  • Sustained ethnic equilibrium
  • On-demand availability
  • Lower incidence of infectious agents (CMV, EBV)

The pilot project has the support of the MSSS.

The expected timetable is as follows:

  • Public announcement of intent on June 20, 2002; ·
  • Detailed program presentation in December 2002; ·
  • Implementation of pilot project in 2003.

In closing, the Executive Director said the next step will consist of developing a business plan.

The members of the board of directors declared themselves satisfied with the presentation. In conclusion, it was proposed, duly seconded and unanimously resolved that the national cord blood bank project be approved.

12. SD plasma
The Executive Director presented a brief overview of the SD plasma situation.

Whereas:

  1. The recent manufacturer's warning takes into account data from the literature, but does not warrant withdrawal of the product;
  2. More than 19,600 units of SD plasma were distributed in Québec, out of more than 2 million units distributed worldwide ? with no reports of any serious incidents;
  3. The only instance of major side effects was observed in a US hospital - no clear cause/effect relationship has been established;
  4. SD plasma supplier American Red Cross has informed Héma-Québec that this product was no longer being manufactured as of April 11, 2002;
  5. Héma-Québec has a limited inventory of groups A, AB and O;
  6. The attending physician must assess the risks and benefits of treatment with SD plasma;

and considering:

  1. Demand for this product has fallen by 60% in the last few weeks;
  2. CBS possesses a sizeable inventory;
  3. The Management Committee made the following decisions at its meeting of May 30, 2002:
    1. Continue distributing SD Plasma until there is no more demand or inventory has been depleted;
    2. No more SD plasma will be purchased from CBS, as there is a high likelihood of not being able to distribute the product before it expires.

For the above-mentioned reasons and considering the recommendation of the Management Committee, it was proposed, duly seconded and unanimously resolved that the recommendation of the Management Committee be approved, that distribution of SD plasma be discontinued once there is no more demand and/or the inventory has been depleted, and that no more SD plasma be purchased from CBS.

13. Project follow up
13.1. 2001-2002 balance sheet

The Executive Director presented a retrospective of Héma-Québec's various sectors for 2001-2002.

13.2. Priority projects for 2002-2003
The Executive Director presented a list of priority projects for 2002-2003. Details are attached hereto.

14. 2001-2002 Demographic report
The annual demographic report for 2001-2002 prepared by the Medical Affairs team was distributed to the members beforehand.

The Executive Director highlighted the very low rate of positive virological test results among blood donors.

15. Risk management
15.1. vMCJ update

The Executive Director reported that a Florida resident who had previously lived in the United Kingdom had been diagnosed with vMCJ. No other US cases have been reported to date.

15.2. Simian foamy virus: Letter from Health Canada
Héma-Québec received a letter from Health Canada on May 9, 2002 stating its position on Simian foamy virus. This letter recommends that no exclusion measures be put into place for the time being.

15.3. Monitored pathogens
The Medical Affairs team has prepared a chart showing the main characteristics of monitored pathogens. This chart will be updated and submitted for information purposes at Board meetings. Moreover, changes will be highlighted to make them easier to see.

16. Miscellaneous
16.1. Appointment of new Scientific and Medical Advisory Committee member: Dr. Sylvain Jude Bélisle

The Board members read Dr. Sylvain Jude Bélisle's résumé and said they are happy to have him on the Scientific and Medical Advisory Committee (SMAC).

It was proposed, duly seconded and unanimously resolved that Dr. Sylvain Jude Bélisle be appointed a member of the SMAC for a five-year term, effective today.

16.2. Resignation of Dr. Mark Wainberg as Safety Advisory Committee member and Chairperson and appointment of Dr. Bryce Larke as Committee Chairperson
The Board members were informed of the resignation of Dr. Mark Wainberg as Safety Advisory Committee member and Chairperson and the appointment of Dr. Bryce Larke as his replacement.

16.3. Pre- and post-relocation inspection by the Blood Establishment Regulation Division (BERD)
The pre- and post-relocation inspection has been conducted by the Blood Establishment Regulation Division (BERD). The inspection was successful. The BERD did not issue any observations.

16.4. Public Héma-Québec meeting of September 18, 2002
The public Héma-Québec meeting will be held on Wednesday, September 18, 2002. A working group comprised from the Liaison Committee is currently developing this meeting.

16.5. National Blood Safety Council meeting of September 12 and 13, 2002
The theme of this meeting is Donors: Meeting the challenge of an adequate safe supply of blood and will take place on September 12 and 13, 2002 in Edmonton. Members who wish to attend are asked to contact the meeting delegate.

16.6. Hemovigilance Committee
The Hemovigilance Committee's public forum will be held on November 15, 2002 at the Radisson Hotel in Québec City. The theme to be discussed is: Transfusion accidents and incidents, and solutions.

The recommendations from the first forum are available at the following Web site: www.msss.gouv.qc.ca/hemovigilance/recommandations

16.7. Joint meeting of the boards of directors of the Canadian Blood Services and Héma-Québec
The two executive directors will select a date that is convenient to the boards of the CBS and Héma-Québec.

16.8. Summary of the International Federation of Blood Donation Organizations (IFBDO) Conference held from May 22 to 26, 2002
The IFBDO conference was held from May 22 to 26, 2002. Twenty countries took part ? a total of 147 registered participants. Dr. Francine Décary, Mr. Robert Bédard and Mr. Jean-Guy Lorrain received the International Merit for Blood Award.

The Donor Representative thanked Héma-Québec for its involvement with the Conference.

16.9. Summary of Scientific and Medical Advisory Committee (SMAC) meeting of May 16, 2002
Dr. Yves St-Pierre summarized the main points discussed at the last meeting of the SMAC held on May 16, 2002.

The matter of intellectual property was discussed and, more specifically, negotiations with Université Laval to draft an agreement on intellectual property. The Committee recommended approaching the various universities.

16.10. Recognition of Dr. Louis Dufresne's work on the Board
The Board members thanked Dr. Louis Dufresne for the dedication and support he has given to the Héma-Québec Board of Directors, where he had worked as a hospitals representative since its inception. A commemorative plaque was presented to Dr. Dufresne.

17. Next meeting
The next meeting will be held on Wednesday, September 18, 2002, at 2:00 PM, at the Montréal Science Centre located on King Edward Pier at the foot of Saint-Laurent Blvd.

18. Adjournment
It was unanimously resolved that the meeting be adjourned at 6:35 PM.

M. Claude Pichette
Chairperson

Dr. Francine Décary
Secretary