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Canadian Public Health Association

Public health and the blood system in Canada: issues and priorities

CPHA submission to the Commission of Inquiry on the Blood System in Canada

Executive Summary

Introduction

The Canadian Public Health Association (CPHA) welcomes the opportunity to present a national, population-based, public health perspective to the Commission of Inquiry on the Blood System in Canada. CPHA advocates for change in a number of policy areas affecting the health of Canadians, including issues of public safety and HIV/AIDS. The blood system in Canada is thus of key concern to CPHA and its members.

This brief describes CPHA's vision of the goals and principles which could frame a reformed blood system in Canada. CPHA's understanding of the key functions of a national blood system isthen described. Recommendations related to the functions of the blood system are made when there is a significant role for and/or impact on the public health system. The brief concludes by proposing an Accountability Model to address the issue of accountability within the national blood system. This model addresses many public health concerns regarding the current blood system.


Goal of a National Blood System

CPHA believes the overall goal of a national blood system should be:

To provide a range of safe and effective products that the best available knowledge and technology make possible, within resource constraints and at an acceptable level of risk.

This goal incorporates a number of key points critical to reforming the blood system in Canada. The first important concept is that of safety and effectiveness, given the current state of knowledge and technology. This is linked to the concept of an acceptable level of risk. CPHA recognizes blood will never be a risk-free product, particularly if "zero-risk" is the criterion. This fact requires public education and debate. Such discussions will need to be informed by the current economic reality, thus recognizing resource constraints. Each of these concepts - safety, current knowledge, resource constraints and acceptable levels of risk - will frame and guide the Canadian blood system.

Principles of a National Blood System

To ensure a safe, efficient and responsive national blood system, CPHA believes the following ten principles are needed to guide the system:

Principle 1:  A "Consumer " Orientation: The ultimate "consumer" is the recipient of blood and blood products - the assumer of risk. All aspects of the national blood system should revolve around, and serve, consumer needs.
Principle 2:  Quality Products: The quality of the product is paramount. Blood and blood products must be regulated from both process and safety perspectives. Products should be judged on the basis of measurable, explicit criteria. These criteria, as well as the benefit/risk and benefit/cost implications of any given product to consumers, should be subject to public input and national debate.
Principle 3:  Publicly Accessible Product Information: Informed consent regarding the use of blood and blood products is a basic health principle which should be respected. Blood product information, including information on the risks which the product poses, must be fully disclosed to the consumer. Information must be communicated in an accessible manner.
Principle 4:  Representative and Inclusive Governance: A method of governance which is representative and inclusive is an essential cornerstone of an effective and efficient blood system. Consequently, it is imperative that the system's structure and governance be explicit at all levels and include a population-based perspective.
Principle 5:  Accountability: The national blood system must be publicly accountable. Accountability measures must be in place at each level of the system. One governing body must assume responsibility for the operation of the system as a whole.
Principle 6:  Open, Public Decision-making: Open, public decision-making must occur. Consumers, as defined in Principle 1, should have input into decisions for which they will ultimately bear (or have already borne) the risk.
Principle 7:  Timely, Informed Decision-making: Decisions must be timely and based on the best information available.
Principle 8:  Efficiency and Effectiveness: Because resources are finite, the blood system must operate efficiently and effectively. Efficiency and effectiveness criteria must be developed with public input.
Principle 9:  Flexibility: Canadians need a flexible, adaptive, forward-looking system. The system must be able to respond to biotechnical advances, as well as other stresses in the system, with reasonable speed and efficiency.
Principle 10:  Collaboration: The national blood system is one small part of Canada's health care program. The medical, ethical and social issues emanating from potential blood-borne pathogens affect many elements of the health care system. Blood system issues cannot be dealt with in isolation from this larger context.

These principles provide the framework on which to reform Canada's blood system.

Functions of a Blood System and Related Recommendations

In approaching the question of how the blood system in Canada could be changed to respond effectively to problems in the future, it is important first to determine the functions which are needed, and then to analyze where improvements could be made. CPHA understands the main functions of a national blood system to include:

  • Research and Development
  • Collection
  • Donor Screening and Blood Testing
  • Donor Notification
  • Recipient Tracking
  • Partner Notification
  • Distribution
  • Quality Control and Post-distribution Surveillance
  • National Reporting
  • Communication

Each of these functions is described in the brief. Specific recommendations related to improving these functions of the national blood system are made when there is a significant role for, and/or impact on, the public health system.

In the brief, recommendations follow the description of each function. Here, the recommendations are grouped in three categories: recommendations regarding screening, notification and tracking; recommendations integral to the safety and efficiency of the blood system in Canada; and a recommendation regarding accountability.

The order of the recommendations reflects the various steps in the collection, distribution and surveillance of the blood system and does not imply an order of importance. The national blood system is complex and will require refinements in a number of areas for overall improvement to be realized.

Recommendations Regarding Screening, Notification and Tracking

  1. Recommendation - Donor Screening
    It is recommended that: A formal review be undertaken of the prospective donor screening form currently in use. As a first step, a meeting of collector/distributor agency representatives, donors, recipients, public health officials, and other stakeholders should take place. The review would examine the rationale and objectives of the various questions posed and identify possible refinements.
  2. Recommendation - Donor Notification re: Test Result
    It is recommended that: When a donor tests positive, the collector/distributor agency assumes responsibility for informing the donor and providing a specific explanation of the test result. This could occur directly through the collector/distributor agency, or through collaboration with the public health system in terms of providing appropriate staff and resources to undertake this donor notification function. The donor notification process will need to be clearly outlined and understood by the collector/distributor agency, the donors and the public health system.
  3. Recommendation - Donor Notification re: Community Resources
    It is recommended that: At a minimum, the collector/distributor of blood be responsible for informing the donors who test positive about community resources which offer counselling, assistance and support. The collector/distributor agency could offer these services directly. If referring donors, the onus will be on the collector/distributor agency to establish explicit protocols with local public health authorities and other community agencies to address local service needs.
  4. Recommendation - Recipient Tracking
    It is recommended that: The collector/distributor agency be responsible for initiating the transfer of information to recipients. A national, computer-based mechanism will need to be in place to "trace-back" past donations. Follow-up services may be provided by a family physician and/or the local public health unit.
  5. Recommendation - Partner Notification and Confidentiality
    It is recommended that: The collector/distributor agency have an explicit confidentiality policy regarding notification protocol which reflects public health standards and public health legislation. This policy must balance the individual's rights with the public's right to health protection.

Recommendations Regarding Safety and Efficiency of the Blood Supply

  1. Recommendation - Equitable Distribution
    It is recommended that: National safeguards be established to ensure the equitable and efficient distribution of blood and blood products for all Canadians, regardless of the product source.
  2. Recommendation - Post-distribution Surveillance:
    It is recommended that: The blood system maintain post-distribution surveillance of blood and blood products by monitoring recipients with a timely "trace-back" to donors.
  3. Recommendation - Comprehensive National Reporting System
    It is recommended that: A comprehensive, national reporting system for blood-borne pathogens be strengthened and maintained. The collector/distributor agency would be responsible for reporting to the appropriate provincial/territorial authority all instances where an individual has tested positive for blood-borne pathogens which are tested for and reportable. This information could then be analyzed at local, provincial/territorial and national levels.
  4. Recommendation - Emerging Pathogens National Forum
    It is recommended that: There be a national forum to debate how to handle emerging pathogens with yet unproven links to disease. This process will need to be open and subject to review. Consensus workshops, Delphi Panels and other means of gathering expert opinion could be used.
  5. Recommendation - Consumer Information Needs/ Communication
    It is recommended that: The blood system be supported by public health research on consumer information needs, health promotion, disease prevention and health protection strategies. And that based on this research, partners in the national blood system provide Canadians with objective, clear, comprehensive information regarding blood and blood products. This information should enable Canadians to make decisions and take action, whether they are donors or recipients of blood and blood products.

Recommendation Regarding Accountability

  1. Recommendation - Accountability Within the Canadian Blood System
    It is recommended that: The Commission of Inquiry on the Blood System in Canada host a multi-stakeholder forum to discuss the implementation and operationalization of a reformed blood system in Canada. The Accountability Model for the Canadian Blood System outlined in this brief could serve as one of the points for discussion.

As highlighted by these recommendations, the public health system plays a significant role in key functions of the national blood system and thus will be an important partner in the reform of the system.

An Accountability Model for Canada's Blood System

Within the principles for a national health system as proposed above, and within the key functions of a national health system, accountability in essential. In the brief, CPHA proposes an Accountability Model which links the principles and functions of a national blood system to the basic need of being accountable to the consumer who bears the ultimate risk.

In preparing this brief, various accountability models for Canada's blood system were discussed. The intent was to improve the openness (operational visibility), responsiveness and accountability of the current system to protect the interests of Canadians who ultimately assume the risk of blood and blood products.

Above all, an accountable national blood system needs to demonstrate:

  • Accountability to the consumer at all levels of the system.
  • Consistency of purpose, a clear mandate and goals.
  • A results-oriented, measurable approach which can be clearly communicated to the public.

Figure 2 in the brief depicts a working model of the elements which CPHA believes to be most central to achieving these outcomes within a public health framework. The specific elements of the model include:

  • Recipient of Blood and Blood Products - Assumer of Risk
  • Governing Body
  • Advisory Committee (with input from existing agencies and technical advisory groups)
  • Federal Regulator
  • Collector/Distributor Agency
  • Provinces and Territories
  • Provincial/Territorial Blood Usage Committees
  • Public Health Authorities
  • Professional Bodies

A description of each of these elements of the models is provided in the brief. The operational details of the Accountability Model are beyond the scope of this brief; however, the model does provide a firm foundation from which discussions of reforming the blood system in Canada could be launched.

The underlying framework for the Accountability Model is one of public accountability provided through a central decision-making body which is representative and inclusive.

This governing body is empowered with adequate resources and authority to implement decisions in a timely and responsive manner.

The national blood system in Canada needs to be strengthened to ensure a reasonable level of safety. This will require a flexible system which can respond to an ever-changing environment involving new and emerging blood-borne pathogens and biotechnology. The reformed blood system should be open and accountable to those it is designed to serve.

Next Steps

In this brief, CPHA has raised a number of important issues regarding the national blood system. Many of these issues require further debate. CPHA encourages the Commission of Inquiry on the Blood System in Canada to host a national Round Table to discuss and clarify these public health issues. These issues include the operational details of an accountability model which incorporates the main functions of a national blood system and the goals and principles which frame such a system.

A Round Table discussion - bringing together academics, public health practitioners, policy makers, recipients of blood and blood products, and the public - to discuss and elaborate upon the proposed Accountability Model and the other public health issues raised in this brief would be beneficial to the participants and to the Commission of Inquiry in preparing its recommendations for reform.

Conclusion

CPHA appreciates this opportunity to present a national public health perspective on the blood system in Canada to the Commission of Inquiry. CPHA and its members look forward to the timely release of the Commission's report, and to the creation of an improved blood system for Canadians.