Minutes of the thirty-eighth meeting
Held at 4045 Côte-Vertu Blvd., Saint-Laurent, in the Boardroom,on Wednesday, February 6, 2002, at 2:00 PM (translation)
Mr. Raymond April
Mr. Robert Bédard
Ms. Sheila Comerford
Dr. Denis Cournoyer
Dr. Francine Décary
Dr. Louis Dufresne
Dr. André Lebrun
Dr. Jean Montreuil
Mr. Claude Pichette
Dr. Yves St-Pierre
Ms. Cheryl Campbell Stee
Hemovigilance Committee observer:
Mr. Jean-Guy Lorrain
Me Smaranda Ghibu, General Counsel
Mr. Simon Fournier, Senior Director, Information Technology
Mr. Guy Lafrenière, Senior Director, Finance and Administration
Ms. Suzanne Poirier, Meeting Delegate
1. Opening of meeting
Claude Pichette chaired the meeting. He welcomed the members. Quorum being established, the meeting began at 2:00 PM.
2. Adoption of agenda
It was proposed, duly seconded and unanimously resolved that the agenda be adopted with the following additions:
- 11.4 Report on HIV seroconversion for a Canadian hemophiliac
- 11.5 International Federation of Blood Donors Organizations (IFBDO) Conference
- 12. Schedule of Board of Directors meetings for the 2002-2003 fiscal year
3. Adoption of the minutes of the thirty-seventh meeting held on December 5, 2001
It was proposed, duly seconded and unanimously resolved that the minutes of the thirty-seventh meeting of the Board of Directors held on December 5, 2001, be adopted as submitted.
4. Business arising from the minutes of the thirty-seventh meeting
4.1. Anti-HBc: update on steps taken with Bayer regarding anti-HBs rate in plasma destined for fractionation
The meeting between Bayer representatives and Héma-Québec representatives initially slated for December 11, 2001 was held on January 15, 2002 with representatives from the Canadian Blood Services (CBS). Further to the postponement of the meeting by Bayer, the Executive Director sent a letter to Bayer advising them of the importance of this matter for Héma-Québec. A copy of this letter and a reply from Bayer were distributed to Board members.
The goal of this meeting was to determine Bayer's specific needs regarding anti-HBs. After discussion, it was concluded that the quantity of anti-HBs in plasma destined for fractionation is not a major concern for Bayer as this antibody is only used for process control. According to a mathematical model, donors vaccinated against Hepatitis B, who represent about 15% of all Héma-Québec donors, would provide sufficient anti-HBs to meet Bayer's needs.
According to Bayer, it is not certain that the US Food and Drug Administration would allow Héma-Québec to send anti-HBc positive plasma to the U.S. for fractionation, even if it is also anti-HBs positive (and thus non-infectious).
Consequently, in order to simplify the implementation of this new screening test, Board members will review the options selected at the June 6, 2001 meeting and will recommend the option with the shortest implementation time.
It was proposed, duly seconded and unanimously resolved that the US option (i.e., testing all donated blood) be added to the options selected for implementation of anti-HBc screening tests. Donor exclusion after one or two tests will be determined by the speed of implementation.
Implementation of the screening test is slated for fall 2002.
4.2. Relocation of Québec City facility: update on talks
The Senior Director, Finance and Administration, submitted a document summarizing the final steps for this item.
The Vice-Rector of Finance and Administration at Université Laval has reiterated interest in the project. Héma-Québec is awaiting a written proposal from Université Laval. However, considering the delay created by these talks, various alternatives are still being considered.
4.3. Stable products budget: letter to the assistant deputy minister of Public Health
The Executive Director met with the assistant deputy minister of Public Health on December 20, 2001. Further to the discussions regarding stable products, the latter has asked Approvisionnement-Montréal to be present during the call for tenders procedure.
The Executive Director explained the selection process implemented further to the joint call for tenders with CBS, and added that the deadline for submitting a bid is February 8, 2002.
Héma-Québec and CBS are currently assessing the structure of five-year contracts for the fractionation service contract, and three-year contracts for stable commercial product contracts.
The National Advisory Committee on Transfusion Medicine (NACTM) was also consulted to get their opinion on stable products to be distributed in Québec.
4.4. Recommendation from the Safety Advisory Committee: Rh-negative plasma
The question of whether the Rh factor should be indicated on plasma bag labels was submitted to the NACTM at its November 2, 2001 meeting. The NACTM looked into the matter and indicated that they agreed with the Héma-Québec Safety Advisory Committee and Board of Directors' position that it is not necessary to label the plasma with the Rh group of the donated blood. The Executive Director pointed out that the Rh factor is available on the shipping slip.
5. Budget follow-up: management report as at December 31, 2001
The Senior Director, Finance and Administration, presented the financial statements as at December 31, 2001. He presented the figures from the 2001-2002 budget for labile and stable products and commented on the budget comparisons by main category. Data on new 2001-2002 capital acquisitions were also discussed. A table of cash assets for 2001-2002 was submitted to Board members. The cash assets position complies with Héma-Québec forecasts. In conclusion, he stated that the budget for stable and substitute products represents an unfavourable variance of $5,070,820 and that Héma-Québec is only the distributor of these products. The Minister of Health and Social Services (MHSS) has been informed of this situation and an additional amount has been earmarked to cover this budget overrun.
The Audit Committee met in the morning and issued the following recommendations:
- Cash assets
In order to achieve a more solid financial balance, the Audit Committee recommended to Finance and Administration senior management that long-term assets be financed through long-term liabilities and not with cash assets or any other short-term assets.
It was proposed, duly seconded and unanimously resolved that the Audit Committee's recommendation to manage Héma-Québec's cash assets by financing long-term assets with long-term liabilities be approved.
- Factor VIII plasma
During the Kogenate shortage, the CBS bought a large reserve of plasma derived Factor VIII plasma that was ultimately not used by patients. These products are about to expire and the CBS will have to assume the cost if a buyer is not found. The CBS is therefore claiming Héma-Québec's share, which amounts to $1.2 million in 2002 and $1.4 million in 2003. The Audit Committee recommended that Héma-Québec make a provision for these amounts, and at the same time, take steps to resell this product in order to minimize potential losses.
It was proposed, duly seconded and unanimously resolved that the Audit Committee's recommendation that Héma-Québec make a provision for its share of Factor VII plasma, i.e., $1.2 million for 2002 and $1.4 million for 2003, be approved and that steps be taken to resell this product.
Héma-Québec should reimburse the CBS its share of the sales tax for Pentaspan, which comes to about $350,000. The Audit Committee recommended that Héma-Québec make a provision for this amount and seek tax advice on this matter.
It was proposed, duly seconded and unanimously resolved that the Audit Committee's recommendation to make a provision for the sales tax on Pentaspan be approved and that tax advice be sought on this matter.
- Interest rate swap
A decision regarding the term interest rate swap contract must be made. Héma-Québec must convert its current loan into a long-term loan by May 15, 2002. To do so, the Audit Committee recommended that Héma-Québec implement a risk tolerance policy that would be applied to decisions of this type.
The Senior Director, Finance and Administration, will obtain an update on the MHSS proposal regarding the financial conditions of the swap.
6. Assessment of bids for nucleic acid tests
The contract with Infectio Diagnostic inc., which was hired to perform nucleic acid testing (NAT), expires on October 31, 2002. As Héma-Québec now wishes to perform nucleic acid testing in-house, it has requested proposals from two companies who manufacture these tests, i.e., Roche Diagnostics (Roche) and Chiron Healthcare Ireland Limited. The Working Group on Qualification Technologies (WGQT) has analyzed the technologies proposed by both companies and has concluded they are equivalent. Consequently, Héma-Québec has requested bids from both companies.
The Senior Director, Finance and Administration, described a financial analysis comparing the costs submitted by these two companies. According to the analysis, the Roche bid is lower. Consequently, the WGQT recommends opting for the Roche proposal.
After discussion, it was proposed, duly seconded and unanimously resolved that the WGQT's recommendation be approved and the proposal from Roche Diagnostics to supply nucleic acid tests be accepted.
7.Stable products: professional fees contracts for information system
Further the request of Board members at the June 27, 2001 meeting to manage stable products in-house, the Senior Director, Information Technology, presented the information technology aspect of this project. In order to manage the stable product inventory, it is necessary to acquire software that will comply with Blood Establishment Regulation Division (BERD) standards as well as Héma-Québec's specifications for stable product management.
The Senior Director, Information Technology, presented the three software suites being considered for stable product management: Progesa, FPMS and SAP. The pros and cons, and the costs of these software suites were discussed. He indicated that the Management Committee decided to select SAP for this project at its December 21, 2001 meeting.
The Senior Director, Finance and Administration, presented a table entitled: "Project cost elements" (Éléments de coût du projet). Several outside resources will be required for various stages of this project, especially for preparation and management, as well as risk management and configuration. To hire these resources, Héma-Québec will have to grant a number of contracts requiring Board approval.
Considering that supplier contracts will be repatriated on April 1, 2003, implementation of this software suite is planned for March 2003, at the latest.
The members discussed the technical and financial aspects at length and concluded by approving the Management Committee's recommendation to implement SAP to manage stable products. In addition, the members authorized the granting of contracts needed to realize this project.
It was proposed, duly seconded and unanimously resolved that:
- The Management Committee's December 21, 2001 recommendation be approved and SAP implemented as the stable product management information system
- The Executive Director be hereby authorized to sign contracts required to implement SAP to manage stable products, including consultation contracts for:· Project management
- Project risk management
- Software suite configuration and sign any other document and take any action deemed necessary or desirable, at her own discretion to give effect to this resolution and to the conditions and commitments contained in the contracts. The Executive Director's signature on the contracts required for the implementation of SAP for management of stable products, and of any such document shall constitute irrevocable proof of Héma-Québec's consent.
8. Québec Human Tissue Conservation Centre closing session: summary
On December 18, 2001, the Québec Human Tissue Conservation Centre transferred its activities to Héma-Québec.
Héma-Québec's priority is to obtain accreditation from the American Association of Tissue Banks. Steps will also be taken to obtain a licence from Health Canada for preparing heart valves.
A business plan will be presented to Board members at the June meeting.
9. Annual inspection of Héma-Québec's Montréal facility by the Blood Establishment Regulation Division: observations and responses
On January 11, 2002, Héma-Québec once again successfully passed its annual BERD inspection. Board members read a Héma-Québec press release and the BERD's observations and Héma-Québec's responses to these observations. All the observations relate to good manufacturing practices and do not endanger the safety of the blood supply in any way. To put the observations in context, the Executive Director explained that all blood donor files from the week of September 11, 2001 - which were more than double the number of files usually completed in one week ? were reviewed, and no observations were noted.
The board members believe that the press release should include more context so it can be more clearly understood. For example, it should explain the number of files reviewed relative to the number of observations made.
10. Public meeting of Héma-Québec Board of Directors
As the Héma-Québec public meeting initially set for September 12, 2001 was cancelled, it was rescheduled for April 3, 2002. The Executive Director proposed rescheduling the meeting for a later date so that the review of Héma-Québec activities include the 2001-2002 fiscal year.
It was proposed, duly seconded and unanimously resolved that the next Héma-Québec public meeting be scheduled for September 11, 2002.
11.1. Appointment of new Scientific and Medical Advisory Committee member: Dr. Jean-Pierre Cartron
The Board members read Dr. Jean-Pierre Cartron'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. Jean-Pierre Cartron be appointed a member of the SMAC for a five-year term, effective today.
11.2. Appointment of a new Scientific and Medical Advisory Committee member: Dr. Walid Mourad
The Board members read Dr. Walid Mourad'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. Walid Mourad be appointed a member of the SMAC for a five-year term, effective today.
11.3. Submission of the minutes of the November 2, 2001 meeting of the National Advisory Committee on Transfusion Medicine
Further to a request by the Board members, the minutes of the November 2, 2001 NACTM meeting were submitted for information purposes.
11.4. Report on HIV seroconversion for a Canadian hemophiliac
The Canadian Hemophilia Society was advised of the case of a hemophiliac who recently tested positive for HIV. This hemophiliac was only treated with recombinant products since his most recent negative test. However, the information known to date would indicate that the seroconversion may be linked to other risk factors rather than the use of the Recombinate.
Héma-Québec and CBS have distributed a circular to hemophilia centre directors, blood bank directors and the heads of technologies in charge of blood to inform them of these facts.
11.5. International Federation of Blood Donors Organizations (IFBDO) Conference
The preliminary program for the 2002 International Federation of Blood Donors Organizations Conference to be held in Québec City was distributed to Board members. This conference, which will be held in Québec City from Wednesday, May 22, to Sunday, May 26, 2002, is the first of its kind in North America. Details of this conference are available in the brochure for members who wish to attend. Additional information is available on the conference Web site at www.dondesang.qc.ca/congresFIODS2002/
12. Schedule of Board of Directors meetings for the 2002-2003 fiscal year
The Executive Director suggested reducing the number of Board of Directors meetings for the 2002-2003 fiscal year. Following discussion, the following dates were chosen: March 6, 2002; June 19, 2002; September 11, 2002; November 6, 2002; February 5, 2003; and March 19, 2003.
It was proposed, duly seconded and unanimously resolved that the meetings for the 2002-2003 fiscal year be scheduled as follows:
- March 6, 2002
- June 19, 2002
- September 11, 2002
- November 6, 2002
- February 5, 2003
- March 19, 2003
A modified version of the 2002-2003 meeting schedule will be sent to Board members.
13. Next meeting
The next meeting will be held on Wednesday, March 6, 2002, at 2:00 PM, at 4045 Côte-Vertu Blvd., Saint-Laurent. A visit of the new facilities is planned for 2:00 PM.
It was unanimously resolved that the meeting be adjourned at 6:25 PM.
Dr. Francine Décary