Backgrounders
	Bureau to Manage Smooth Transition to the New Blood System

Information

October 1997

The new Canadian Blood Services and the new blood system

1. Features of the new system

Provincial and Territorial Health Ministers will be responsible and accountable for the national blood program, including funding, setting broad health policy objectives, serving as members of the new authority responsible for Canadian blood services, ensuring the overall integrity of the blood system and exercising their on-going powers and responsibilities as Ministers under existing health legislation.

The mandate of the Canadian blood services is "to be responsible for a national blood supply system which assures access to a safe, secure and affordable supply of blood, blood products and their alternatives, and supports their appropriate use."

The Canadian blood services will own and operate the blood supply system, and be responsible and accountable for the following:

• recruiting blood donors and managing blood donation;
• collecting whole blood, plasma and platelets;
• testing and laboratory work;
• processing, storage, distribution and inventory management;
• developing and implementing quality assurance/quality control standards;
• coordinating a national program in R&D for blood, blood products and transfusion medicine;
• establishing public and professional ducational programs directed at appropriate utilization of blood and blood products;
• purchase and distribution of commercial blood products
• surveillance; and
• health risk management.

The new Canadian blood services authority is the vehicle by which governments will deliver a national blood program effectively and efficiently, and achieve donor-to-patient integration and transparency for consumers and the public.

The Canadian blood services will not assume or be responsible for the regulatory powers of governments.

2. The Canadian blood services

The new Canadian blood services authority is to be established initially as a corporate body in accordance with Part II of the Canada Corporations Act with corporate members (Provincial and Territorial Health Ministers) who play a role similar to shareholders.

Subsequently, Parliament will be asked to adopt framework legislation enshrining the mandate and structure of the authority using the federal power to establish corporations having national, interprovincial or international objects.

The Canadian blood services authority is to be established in a manner which permits its subsequent registration as a charity forpurposes of the federal, provincial and territorial tax laws.

The corporate members will be assigned powers and functions "as members" which are in addition to their ongoing roles and responsibilities as Ministers of Health.

The new authority will be funded through grants and contributions from participating provincial and territorial governments; therefore, governments must have appropriate safeguards to ensure fiscal accountability.

The authority will exercise complete management discretion over all operational blood system decisions.

The domain of management discretion will include matters of health and safety with respect to the blood system. Decisions in this regard will be made within a health risk management framework which places on an equal footing the three critical elements of benefit, risk and cost.

As the owner/operator of the blood system, the new blood services will require all appropriate licences under the federal Food and Drugs Act and will comply with federal regulations, and meet the same health and safety standards that apply to all manufacturers of biologic pharmaceuticals.

3. Responsibilities and Functions

Provincial and Territorial Health Ministers, "as Ministers"

Notwithstanding their involvement in the new Canadian blood services, Ministers remain accountable for their ongoing powers and responsibilities as Ministers of Health, in accordance with existing health legislation.

Ministers are responsible for:

• the effectiveness of the blood supply system as an integral component of the Provincial/Territorial health care delivery systems
• funding requirements of the new blood authority as approved by its members
• recommending to the Minister of Health (Canada) any proposed changes to the new authority's legislation.

Provincial and Territorial Health Ministers, "as members" of the new Canadian blood services

Participating provincial and territorial Ministers, serving as "Members" will establish and will remain responsible for the mission and mandate of the authority.

Members will have the authority to approve, upon the submission by the new blood services Board of Directors, the three-year corporate business plan, which includes its annual global budget and performance objectives, and a plan to allow for a contingency fund for emergencies, and, where necessary, to provide guidance to the Board on the contents of the plans.

While participating Ministers "as members¹" will not have the power to direct operational decisions of the authority's Board of Directors or staff, the members will be responsible for:

• overall expenditure of public funds by the authority in delivering the blood program, and
• selecting a Board of Directors.

The Board of Directors will consist of a minimum of 7 and a maximum of 13 comprising a Chair, four Directors elected on the basis of nominations from members representing the regions of (1) British Columbia & Yukon, (2) Alberta, Saskatchewan, Manitoba and the Northwest Territories, (3) Ontario, and (4) New Brunswick, Prince Edward Island, Nova Scotia and Newfoundland; two Directors elected from the general public on the basis of their relevant knowledge or experience with organisations representing persons who are consumers of blood and blood products; and up to six other directors elected on the basis of their relevant knowledge or expertise in business, scientific, medical, technical or public health matters. New members can join the new authority with the unanimous consent of existing members.

Employees of the federal, provincial or territorial governments will not be eligible for appointment to the Board.

Members will have the authority to require direct, external, comprehensive management audits and targeted special audits at their discretion.

Should objectives for the blood program not be met satisfactorily, members will hold the Board accountable to take corrective action.

Members will retain the power to remove some or all of the Board.

Members will publish an annual report, including its audited financial statements.

Responsibilities of the new Canadian blood services Board of Directors

The Board of Directors is responsible for the overall direction of the affairs, operational activities and budget of the authority, including the appointment of the Chief Executive Officer.

The Board of Directors is responsible for translating the approved business plan into blood system operations.

• exercises broad discretion in establishing corporate and operational policies of the authority, including setting and enforcing standards;
• is responsible to the members for achieving the goals of the approved business plan, which includes its annual global budget and performance objectives for the authority;
• is accountable for reporting on the authority's performance to Ministers "as members."

The Board is responsible for the development and implementation of Canadian blood services standards supplementary to any regulatory standards of the federal, provincial or territorial governments.

The Board is expected to develop corporate and operational policies reflective of the principles contained in provincial and territorial statutes dealing with public access to information about the affairs of the authority, protection of personal information controlled by the authority, and the provision of service to the public where appropriate, in the official language of their choice.

The Board will be required to create a Finance Committee and will have the authority to appoint committees as they deem necessary to advise and assist them in carrying out their duties.

Although Ministers will remain accountable for the use of public funds, the internal Finance Committee will be responsible for preparing authority budgets for the approval of the Board of Directors.

Responsibilities of the Chief Executive Officer of the new Canadian blood services

• responsible for the management and day-to-day operation of the authority's programs and activities, including the supervision of the authority's staff.
• responsible to the Canadian blood services Board of Directors for implementing corporate and operational policies as directed by the Board.
• responsible for ensuring all executive decisions are made within an analytical framework of health risk management.

The Chief Executive Officer will be required to create Consumer Advisory, Scientific Advisory and Research and Development Committees and will have authority to appoint committees as he or she deems necessary to advise and assist in carrying out his or her duties.

The Board of Directors may also, at their discretion, appoint consumer advisory, scientific advisory, and research and development committees, or may require the CEO's committees to provide advice directly to the Board.

4. Fiscal Accountability Framework

Notwithstanding the decision framework to be established for business planning at a global level, the CEO would retain the authority to make timely decisions on the advice of the Scientific Advisory Committee, concerning the expenditure of funds for emergency safety response. In this regard, the authority would have the capacity to function in a true "arm's length" fashion, effectively discharging its responsibility to ensure national access to a safe supply of blood and blood products.