Canada's Blood System
Canada’s blood system needs to be managed under specific guidelines and principles to ensure that safe, efficacious blood, blood products and their alternatives can be provided to Canadians. The guidelines and principles discussed here are based on standards for quality control, quality assurance, good manufacturing practices, and good management procedures which are essential to any complex technological system.
3.2 Optimal Quality
Thirteen criteria for ensuring the safety of blood products are listed here. Some of these are goals which can help to support safety; others are means by which risks can be minimized.
a) Fresh components - The use of voluntary* unpaid donors for the provision of fresh components (red blood cells, platelets, fresh frozen plasma) increases the safety of these components and must be maintained. It is not, however, the only means of achieving safety; nor is it sufficient, in and of itself. The most advanced risk-reduction measures (currently including donor selection, testing of individual donations for all known disease-causing blood-borne pathogens and leuko-reduction) must be continuously reviewed and implemented.
* Voluntary is defined as meaning blood or plasma which is freely given without coercion. Unpaid does not necessarily mean unremunerated. We support strategies for increasing voluntary donations which provide token remuneration such as reimbursement of travel costs, payment of meals or time off work to allow donation.
Plasma products - While the Canadian blood system may choose to rely entirely on the plasma of unpaid donors for the provision of plasma-derived products for ethical, social or economic reasons, this choice should not be solely based on arguments of increased safety. Other mechanisms, including donor selection, repeat donors, quarantine of donations, testing of individual and pooled donations, purification, filtration and approved viral inactivation processes are primarily responsible for the safety of plasma-derived blood products.
b) Because of the risk of widespread contamination of a blood source, the Canadian blood system must not rely on a single source of supply. It must have available, at all times, alternative and contingency supplies (and suppliers) to which to switch in case of emergency.
c) Established procedures for the selection, screening and self-exclusion of donors must be implemented and monitored at all times. (See 2.2, Optimal Quality.)
d) All source plasma must be tested for known contaminants and quarantined for sufficient time until repeat screening results indicate that the original donation was free of known contaminants.
e) Procedures for the management of plasma pools must ensure accurate recording of all donors and rapid retrieval of information.
f) All blood components and blood products must be traceable vein-to-vein. The system must allow for efficient and complete retrieval of information on all products in distribution including donors, recipients, quantities outstanding and their locations by lot number.
g) All plasma-derived products — e.g. factor concentrates, IVIG and albumin — must be treated with a proven effective viral inactivation process.
h) An emergency response plan to deal with potential viruses or other risks to the safety of the blood supply or to blood products is required. One central authority must have a legislated mandate to monitor the continued safety of all aspects of the blood system, including reviewing adherence to approved procedures, and all unexpected or adverse reactions.
i) The conditions indicating a potential emergency must be defined, including the identification of the authorities responsible for monitoring indicators of a potential emergency.
j) A plan for alerting users of blood products, either individually or the public at large, about an emergency situation is required.
k) A plan for speedy and efficient product recall and substitution of product is required. All authorities must be aware of their responsibilities.
l) There must be contingency funds and pre-authorization provided to the appropriate organizations or agencies to expend funds under emergency conditions.
m) There must be a regular, independent, expert audit of all aspects of the blood system including its safety procedures, decision-making and management.
3.2.2 Therapeutic Value
To ensure optimum therapeutic value, the blood system needs to meet the following parameters of performance:
a) A full range of state-of-the-art products must be available to meet individual needs of recipients.
b) Advances in treatment products and modalities must be reviewed regularly and expeditiously to ensure that treatment in Canada is consistent with the highest therapeutic standards.
i) A process for coordinating research information and performance updates on new directions in therapy must be established involving all members of the blood system, including the medical community, the patient organizations and the government agencies.
i) There must be a thorough process for reviewing and approving Investigational New Drugs. Delays in approval should not be the result of a lack of resources within Health Canada.
ii) There must be an expeditious process for reviewing and approving funding of new products, with clear criteria for funding through the Special Access Program.
c) A process for dealing with adverse reactions to both old and new treatments must be clearly defined.
i) A mechanism for monitoring, reporting, analyzing and responding to adverse reactions is required.
ii) A system for disseminating adverse reaction information to hospitals, blood banks, physicians and patients is required.
d) An inventory of products packaged in a range of sizes should be maintained.
e) There must be an active post-marketing surveillance system for adverse reactions, including blood-borne pathogens transmitted through the use of blood, blood products and their alternatives.
3.2.3 Choice of Product
a) To ensure clinical choice of blood products and other biologicals, patients, medical professionals, and the purchasing authorities must have a process for regular feedback and consultation.
i) The physician has the ultimate ethical and legal responsibility for prescribing treatment. The patient must be fully informed about the treatment options and participate in the mutual decision-making process.
b) There must be a system which allows physicians and patient access to a full range of treatment options and the ability to switch to higher quality treatments as they become available.
i) The national system of centralized purchasing and supplier contracts should be preserved because of economies of scale and guaranteed access to products.
ii) There should be no exclusive supplier (single manufacturer) contract.
c) Any long-term supply contracts or other long-term commitments of provincial funds must include penalty clauses for non-respect of contract provisions. They must also include provisions for opting to the supplier’s latest state-of-the-art products.
d) Provision must be made for autologous donations.
e) Provision must be made for directed donations when, on the recommendation of the physician, such a donation will either reduce the risk or significantly reduce the stress involved in surgery and/or transfusion.
3.2.4 Donor Selection
a) The safety of blood and blood products for the recipient, and the safety of the donation process for the donors, are paramount in the donor selection process.
b) The CHS supports the development and early application of new technology and new scientific knowledge to continuously improve the safety of the blood system for the recipient.
c) The CHS expects that everything humanly possible will be done, based on sound scientific evidence, to educate, attract and select donors; to screen them; and to test the donated blood to ensure the safest possible blood supply.
d) The fundamental CHS position on donor screening and selection methods, including the donor questionnaire, is that they exist for only one purpose: that is, to protect the recipient of the blood donation to the maximum extent possible from harm caused by blood-borne infectious diseases. (Notwithstanding, the CHS also recognizes and supports the inclusion of additional questions and procedures intended to protect the health of the donor).
e) The CHS is cognizant of, and grateful for, the altruistic gift of a blood donation, but recognizes that while the donation is voluntary, the receipt of blood is effectively not. Thus, the objective of any question on the donor questionnaire is to detect and exclude any potential risk in a donor.
f) It is recognized that the blood system can never be completely safe, but because it is recipients who must bear 100% of any risk (no matter how small), the CHS supports a “zero tolerance” of avoidable risk in blood donor screening and selection. In an imperfect system, any errors that are made must favour the recipient of the blood.
g) The CHS appreciates the progress that has been made in minimizing the risks of HIV and the hepatitis viruses to the blood supply, but is concerned about the “next HIV”; the emerging blood-borne virus that has not yet been seen. Since it is reasonable to assume that any new blood-borne virus will likely be transmitted through the same risk factors (geography and behaviour) that have come to be associated with HIV and the hepatitis viruses, and the only line of defense is the donor questionnaire, the CHS insists that consideration of any proposed changes to the donor questionnaire be based on the Precautionary Principle or on validated scientific evidence that safety is not compromised.
h) The CHS urges the Canadian blood system administrators to manage issues of blood supply, and donor recruitment and participation, through public education and marketing science, and not at the expense of rigorous donor screening criteria.
3.3 Optimal Supply
a) There must be assurance of adequate source plasma to meet needs; if increased needs for blood products are identified, the amount of source plasma obtained needs to increase.
b) Strategies for ensuring adequate plasma donations (recruitment and frequency of donations) need to be developed.
c) While there may be ethical, social or economic rationales for becoming self-sufficient in plasma needed to make blood products, history has demonstrated that Canadian self-sufficiency (i.e. plasma from Canadian donors) is not required to ensure an adequate supply of high quality plasma products.
d) Because of the risks of contamination by a new blood-borne pathogen, plant breakdown and the volatility of blood supply, reliance on a single supplier carries the risk of not having adequate blood products to meet patient needs. Alternative suppliers must be identified and available to lessen the impact of shortfalls.
e) Contingency supplies must be available if an existing supply is interrupted due to contamination of source, disruption in fractionation or manufacturing, or labour stoppages in collection, processing, or distribution.
3.4 Surplus Plasma Fractions
Surplus plasma fractions (for example, factors VIII and IX) should not be wasted if there is a worldwide need for them. Such waste would be doubly unfortunate given the high level of safety of Canadian plasma, compared to plasma from some countries which do not use the complete range of risk-reduction methods.
These products can either be provided as humanitarian aid, sold at cost, or sold with a return on investment. Revenues that are generated through the sale of surplus manufactured products or surplus raw materials must remain within the system to offset the cost of, for example, genetically-derived substitutes, or be reinvested into research and development into safer, more effective therapies.
While hospital-based funding, as opposed to global provincial funding, may offer certain advantages regarding the purchase of fresh blood components (e.g. fairer comparison with blood alternatives or transfusion-reduction methods such as operating room blood recycling), CHS believes that there are no such advantages regarding the purchase of factor replacement products, given the clear indications for their use and current monitoring through Hemophilia Treatment Centres.
a) The Canadian blood system should study the implications of hospital-based funding through small-scale pilot projects before implementing it on a large scale.
b) Hospital-based funding must not be extended to include factor replacement products.
c) Factor replacement products must continue to be purchased nationally and funded through global provincial budgeting based on provincial usage.
3.6 Research and Development
a) Provision must be made for a percentage of the total blood system budget to be earmarked for research into improving treatment for, or curing, blood-related diseases; and improving transfusion medicine practices.
b) The availability of research funds must be made known publicly. There must be no limit on who can compete for grants. Allocation of research monies must be done by a peer-reviewed grants committee which reports to the Boards of Directors of the Canadian Blood Services and Héma-Québec.
a) The decision-making process and the finances of the blood system must be made entirely transparent to the Canadian public. Transparency is defined as communication which …
• is clear and comprehensible
• is complete
• is frank
• tells the whole truth
• admits to doubt and lack of information
• is nurtured by a spirit of openness
• reflects a genuine desire to be transparent
• facilitates the proper evaluation of issues.
a) The legal status of the Canadian Blood Services and Héma-Québec must be one that ensures accountability to the public.
b) The relationships amongst the players in the blood system must be ones that are devoid of conflicts of interest.
a) The Boards of Directors of the Canadian Blood Services and Héma-Québec must be made up of people who are knowledgeable and experienced in areas related to the blood system, for example: transfusion medicine, quality control, good manufacturing practices, management and finances. Their individual expertise must be matched to their responsibilities.
b) Members of the Boards of Directors of the Canadian Blood Services and Héma-Québec must devote sufficient time, among their other responsibilities, to adequately perform their duties.
c) There must be representation by recipients* of blood, blood products and their alternatives on the Board of Directors of the Canadian Blood Services and Héma-Québec and on its various advisory committees.
* “Recipients” are defined as people who represent the “end-user” of blood, blood products and their alternatives and who have a clear interest in their safety and accessibility now and in the future; that is, patients or their close relatives (parent, spouse, child).
a) Clearly defined lines of communication must be established among the different players in the blood system. Effective communication is essential in the following areas:
• optimum treatment regimes;
• adverse reactions;
• new developments in research.
b) As more and more alternatives to blood and blood product transfusions become available, physician and consumer education must be a priority strategy to ensure their judicious use.
3.10 Misadventure Insurance
To further responsible decision-making within the blood system and to ease the hardship of those injured through the use of blood and blood products, a blood related injury program must be set up in cooperation with the suppliers, and in consultation with stake holders whose members regularly use these products. The compensation scheme must provide real benefit to those injured. As an effective incentive to minimize the incidence of injury, the scheme must not take away an individual's right to sue those responsible at law for their injuries.