HEAL Committee Report
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For witnesses, the overriding emphasis was on the need for a national perspective on the donation and transplantation of organs and tissues. They emphasized that Canada is unique among other industrialized countries in not having a national body or organization responsible for managing or coordinating the elements of donation, procurement, allocation and transplantation. They saw a national approach as one involving the federal government as a key partner with the provinces and territories. Many witnesses described transplantation as an unique example of a healthcare procedure completely dependent on public participation for success. This uniqueness, they suggested, supports the argument that organ and tissue donation and transplantation should have a national framework involving support from all levels of government.
This section outlines the rationale and structure for a national body to coordinate activities related to organ and tissue donation and transplantation. It identifies the key concerns of witnesses in relation to data collection, public and professional education, accountability processes, and standards.
A. CANADIAN TRANSPLANT NETWORK
The primary recommendation of witnesses was for a national integrating mechanism that would involve all levels of government in monitoring and assessing all aspects of the data collection and utilization, professional education and training, facility licensing and accreditation processes. A constantly repeated refrain was that all aspects of donation and transplantation require more than just goodwill. Witnesses emphasized that it requires organization, funding, and accountability at the national, provincial, and local levels and asserted that it needs a central system to accomplish this effectively. They called for a central body with authority to lead and to take action if the outcomes are unsatisfactory. They stated that only a national structure can look at what actually goes on, evaluate what works in each province, and build an effective system that is accountable and accessible to all Canadians.
The national model adopted by Spain in 1990 was frequently cited as a possible example for Canada to emulate. Since the inception of the Organizacion Nacional de Trasplantes, the organ donation rate has doubled from 14.3 donors per million population (pmp) in 1990 to 31.5 donors pmp in 1998. In addition, the number of organs transplanted has tripled since 1990. The Committee heard that the national organization, attached to the national health department, has an annual budget of $3 million U.S. for the inter-regional offices, database management and training programs and $11 million U.S for the in-hospital performances, including personnel, ICU, OR and related facility costs. This organization operates within a national healthcare system in a country with 40 million inhabitants occupying 17 autonomous regions. Within this national health system, the general budget for health is allocated and managed regionally, resulting in varied hospital budgets and physician salaries. The Committee is very interested in adapting facets of the Spanish model along with other international experiences to the Canadian situation. It is aware that there are differences between Spain and Canada that emphasize the need for a made-in-Canada approach. Differences such as geographic size, number and organization of physicians and hospitals, cultural diversity, political climate are among the variables that must be considered.
Several different models for the establishment of a Canadian national approach were discussed in the Committee hearings. These included: the National Coordinating Committee on Organ and Tissue Donation and Distribution (NCC); the Coordinating Committee on Reciprocal Billing (CCRB), the Canadian Coordinating Office on Health Technology Assessment (CCOHTA), the Canadian Institute for Health Information (CIHI) and the Canadian Blood Services (CBS). As discussed in the previous chapter, all involve the federal government to varying degrees. Thus, while all receive some federal money, the first four report through a federal, provincial and territorial structure and the last through a provincial and territorial one. Thus, the NCC and CCRB report to the F/P/T Advisory Committee on Health Services; CCOHTA and CIHI report to the F/P/T ministers of health, and the CBS reports to provincial and territorial ministers of health.
The Committee heard repeatedly that a national coordinating structure to integrate all facets of the donation/transplantation continuum is needed now. Witnesses called for a national body that would provide the continuous umbrella structure to ensure overall continued coordination of all key elements in donation and transplantation. The Committee agrees that a national framework should replace the current fragmented and piecemeal approach to organ and tissue donation and transplantation. It recognizes that any such national framework must be adequately funded and have a continuous and visible organizational structure. It acknowledges the importance of using existing donation and transplantation expertise and of maintaining the established cross-national networks. However, it stresses the need to have a distinct body that is visible to the general public, responsive to healthcare professionals; accessible to facilities and accountable to provinces.
1. In light of the repeated calls for a national coordinating and integrating body to provide oversight in this emergent healthcare area, the Committee recommends that:
1.1 The federal/provincial/territorial ministers of health establish the Canadian Transplant Network to oversee organ and tissue donation and transplantation;
1.2 The federal Minister of Health ensure that the establishment of such an organization and accompanying strategy be discussed formally with provincial and territorial counterparts within the next six months;
1.3 This organization have a permanent secretariat and an appropriate budget;
1.4 This organization provide annual public reports through the F/P/T Conference of Ministers of Health; and,
1.5 This organization provide annual reports through the federal Minister of Health to Parliament on results accrued from federal contributions and such reports be considered in connection with National Organ Donor Week.
Witnesses suggested that this Canadian Transplant Network must have a capacity to oversee and provide annual public reports on the status of four key components or program areas that should be part of its mandate. These programs or components would provide oversight of: (1) individual intention to donate; (2) potential donor identification, management and eventual procurement from actual donors; (3) waiting list, sharing, matching and allocation; (4) transplantation outcomes. Each program area would be the responsibility of specific staff members within the secretariat.
The Committee heard from many of the individuals and organizations active in donation and transplantation in Canada. It recognizes the varied and comprehensive expertise that currently exists in communities across the country. This knowledge is essential to any national organization and could be used effectively in a part-time advisory function to the permanent secretariat. Thus, using this existing knowledge, each program area would seek advice from expert advisory groups working through specific staff units. Each could develop benchmarks within their respective areas and establish timelines for achieving them. This setting of clear goals then provides the national body with a way to measure results and outcomes.
2. The Committee therefore recommends that:
2.1 The Canadian Transplant Network be composed of four permanent program areas using expert advisory groups to address respective areas: individual donor intent; potential and actual donor identification and management; sharing, matching and allocation of donated organs and tissues; and transplantation outcomes;
2.2 The expert advisory groups be composed of members drawn from existing organizations involved in organ and tissue activities and rotated on a regular basis;
2.3 The expert advisory groups be responsible for providing direction to the Canadian Transplant Network on the establishment of goals and the measuring of outcomes; and,
2.4 These goals and outcomes be included in the annual report produced by the Canadian Transplant Network on each specific program area.
B. ORGANIZATION OF THE CANADIAN TRANSPLANT NETWORK
The following sections examine the main requirements for each of the four program areas and their respective advisory groups in overseeing the activities important to an integrated and coordinated national approach. Using the evidence from witnesses, the Committee envisions several roles to be assumed by the Canadian Transplant Network through its specific expert advisory groups. These include oversight and monitoring of data collection, assessment and dissemination; public and professional education; accountability processes and structures for professionals, facilities and governments; and standards applied as ethical principles, medical or nursing practice protocols, and regulatory rules.
1. Expert Advisory Group for Donor Intent and Consent
Discussions about donation frequently emphasized how many people advocate support for donation compared to how few actually have their organs or tissues used in transplantation. The Committee heard frequently about public opinion polls indicating that up to 90% of Canadians support organ and tissue donation.
Some witnesses suggested that a national database that registered the intent of individuals to donate would increase the supply of available human tissues and organs. They argued that identification of an individual intention to donate would facilitate the process of linking a potential donor in a hospital to a potential recipient. To achieve this, the system would track individuals on an ongoing basis; be readily accessible to individuals in hospitals; and be linkable to a registry or waiting list of transplant candidates.
However, other witnesses pointed out that countries with the highest donor rates, including Spain, do not have registries of intent to donate. Others noted the complexity of developing and cost of maintaining such a database and questioned whether it would lead to substantial benefit. For example, they asked about ensuring the validity of the information given that individuals change their opinions, locations, relationships, and other circumstances of their lives that might affect their record of intent. They questioned the extent of information to be collected for the database. They wanted to know how the registry would address concerns relating to privacy and confidentiality in the collection and ongoing administration of the database. Indeed, the federal Privacy Commissioner warned against the hazard of encroaching on the basic human right of privacy.
The Committee received evidence about two Canadian provincial registries of intent to donate. Both the Nova Scotia and the British Columbia registries record an individual's intention to donate all or some organs and tissues. Both registries aim to assist professional staff and next-of-kin in the consent process at the hospital. The Nova Scotia registry began in 1995 and is currently piloting direct-line access to the database via the Internet. Established in 1997, the British Columbia registry links a signed legal document stating a donor's wishes with regard to specific organs and tissues with the individual's health number. The electronic scanning of this document enables it to be reproduced if the individual subsequently appears at an intensive care or critical care unit within the province and is identified as a potential donor.
The Committee received some funding information about both registries. The British Columbia registry operates within the larger organizational structure of the British Columbia Transplant Society that receives almost $23 million annually from the provincial health ministry. The provincial registry itself was developed at a cost of $500,000 with an additional $500,000 for its public information campaign. The registry is currently maintained by $100,000 for technology and staff with additional money for promotional costs. The Nova Scotia registry is maintained by the provincial health ministry's Medical Services Insurance Branch. Because the intended donor registry is linked to the registration for new health cards, the personnel and technological systems are already established, resulting in minimal costs for the additional data entry. The estimated cost of connecting to transplant centres via Internet is about $25,000 and is primarily related to consultations about data security.
In the tissue area, the Canadian Unrelated Bone Marrow Donor Registry (UBMDR), founded in 1987 by the Bruce Denniston Bone Marrow Society, was taken under the umbrella of the Red Cross in 1989. The registry now exists under the CBS and has a current budget of approximately $2.5 million for infrastructure; however, the development of a new National Molecular DNA Laboratory to perform typing for potential matches would cost an estimated $8 to $10 million.
Witnesses noted that many voluntary mechanisms for registration are limited in their ability to attract participants. The specific donor cards of procurement organizations may not be readily available, many adults do not drive automobiles and therefore do not receive motor vehicle or license renewals. For most provinces, the health card is the mechanism of choice for registering intent to donate. This raised the issue of whether registration should be voluntary or mandated. The current system employed by Nova Scotia through the provincial health card renewal process and British Columbia through forms received from motor vehicle permit offices, London Drugs, and various other locations is voluntary. For the Unrelated Bone Marrow Donor Registry, donors are largely recruited from patient-inspired or family campaigns. Advocates of mandated choice, as a means to establish an intended donor registry, suggested two possible avenues at the federal level, either the census or the income tax forms. The goal would be to make it a legal requirement for respondents to provide a "yes, no or don't know" indication for registry purposes.
Critics of a mandatory approach expressed concern about a compulsory legal requirement to register and about the subsequent application of this advance declaration of donation intent at the hospital. Most people working in hospitals insisted that, even when people have indicated a desire to donate, when they are assessed as suitable candidates at the hospital, their families or next-of-kin should be asked for permission. Others, particularly recipients, asserted that a donor's wishes should be honoured and that the current practice of asking families means that a legally authorized consent can be bypassed.
During testimony surrounding the data questions on intent to donate, the Committee heard that the establishment of a national intended donor registry would not be the most efficient use of resources, nor the most effective means of increasing donor numbers. In particular, the Committee was strongly influenced by the experiences in both Spain and the United Kingdom. Spain has experienced a high rate of actual donation without a national intended donor registry. The United Kingdom, where a national intended donor registry was launched in 1994, received data from a very small proportion of the population (less than 6 million out of a population of 57 million) and saw a decrease in the number of actual donors (from 823 in 1997 to 758 in 1998). The Committee commends those provinces that have developed such registries as one component of their organ and tissue programs and feels that the current voluntary system of obtaining donor intent is appropriate. It also suggests that the provincial and territorial health cards provide a logical vehicle whereby all provinces and territories could collect this data seen as important for facilitating donation discussions with families and next-of-kin in the hospitals.
Witnesses were virtually unanimous about the need for coordinated, ongoing and comprehensive public and professional awareness campaigns in the area of organ and tissue donation. It was suggested that this is an area in which the federal government, separately and through a national effort, can play a very important role. Presently, education initiatives are carried out sporadically through public awareness efforts such as those undertaken by the Kidney Foundation and the Bruce Denniston Bone Marrow Society while professional awareness approaches are undertaken by professional organizations such as the Canadian Association of Transplantation. The Mutual Group, which has worked with these organizations, reported that it has invested more than $3.5 million since 1992. It also emphasized that raising public awareness at this stage will only translate into increased donation rates if healthcare professionals take appropriate actions geared to donor identification at the hospitals.
For the public, a key message was that individuals who intend to donate must express their wishes to family members. The Committee heard that up to 96% of relatives agree to organ donation if they already know of the individual's wishes compared to only 58% when the family has not previously discussed the issue. In a hospital setting, awareness of prior individual consent is a key variable in acquiring relatives' consent to organ donation. Theoretically, one third of potential donors are lost when families or next-of-kin refuse consent.
Professional education and training were also seen as essential components of any effort to improve donor numbers. Witnesses pointed to the organizations representing healthcare professionals, the facilities where they work or the universities where they were educated or with which they are affiliated as centres for such activities. For professionals at this early stage in the donation/transplantation continuum, the main education issue involved their ability to assist an individual in making a decision about intended donation. Because healthcare professionals at the primary care level request a health card on every office visit and because the health card is currently the preferred mechanism for recording donor intention, some witnesses suggested that medical visits would present opportunities for passing on accurate and timely information. In order to help an individual to reach a truly informed decision about donation, the physician or nurse would need information about the actual donation process that commonly takes place in a hospital setting but that, for some tissues, may occur in a clinic.
Witnesses presented several options for individual consent for intended donation, specifically mandated choice and informed choice. Mandated choice would require that all competent people decide and record their intention with respect to donation. This method allows people to change their minds but also dictates that the expressed wishes are binding; that is, that there could be no later family intervention. The Committee heard that mandated choice has several advantages. It raises public awareness of the donation issue; it reduces stress on the next-of-kin as well as staff through confirmation that the intent to donate was decided at a less emotional time; and it enhances timely organ procurement while preserving the altruistic quality of donation. Surveys in the United States suggest that 63% of the population would sign up under such a system.
In relation to donor intent, other witnesses argued that the current expression of an individual's wishes to donate is probably not based on full information about the procurement procedures, thereby making it necessary to explain all aspects of the donation process more completely to next-of-kin. They insisted that truly informed choice, which leads to either informed consent or informed refusal, in relation to organ and tissue donation goes beyond increasing public awareness of the need for donations. Enabling the individual to choose freely on the basis of full information could mean the development of a national program to disseminate information on significant issues such as brain death and on details of procurement procedures for tissues and organs. Spain has an information service to support its organ donation system available on a 24-hour a day basis. The Canadian UBMDR is currently attempting to get funding for a toll free number for queries that could be directed immediately to an appropriate expert.
The Committee feels strongly that information is key to obtaining informed consent of intended donors and later of their families or next-of-kin. The goal is fuller understanding of the medical, legal, ethical, social and psychological implications of donation. The Committee concurs with witnesses who promoted the use of social marketing campaigns targeted to particular population groups such as those currently employed in anti-tobacco or prenatal care efforts. Additional suggestions were for prepared information packages to be supplied or made available to intended donors on provision of intent through a health card or donor card. Other witnesses advocated the use of innovative information technology to serve Canadians in this emerging area.
The Committee would like to see donation information for both the public and professionals managed on a more national scale. It believes that family physicians are in a position to play an important role in educating their patients on the issue of organ and tissue donation and would like the relevant professional bodies to develop informative material and training courses for general practitioners. It is of particular concern to the Committee that any individual indicating an intent to donate be fully informed of the processes of donation and of any consequences for a family member or next-of-kin.
Witnesses often referred to the need for accountability within any system addressing the donation and transplantation of organs and tissues. They called for clearly established and publicly visible processes and structures within which responsibilities could be assigned, outcomes monitored and findings reported. In relation to donor intent and consent, they referred primarily to the evaluation of registries and their need for structural accountability. Determining the effectiveness of public and professional educational campaigns was also considered necessary.
The Committee heard from supporters of the British Columbia registry that the supply of available human organs and tissues will increase with the establishment of the centralized computerized registry of individuals willing to donate. Because it has been in operation for only 16 months, the evidence to support this claim does not yet exist. To date, nearly 180,000 individuals have registered their wishes regarding organ donation but the Committee did not receive information about the number of actual donations procured through the registry. In Nova Scotia, 70% of the population was registered by February 1999, with 39% of these indicating intent to donate organs or tissues. Provincial officials suggest that the registry has encouraged healthcare professionals to approach families; raised public awareness among all provincial residents; and provided aggregate data to identify target groups for further education.
With respect to tissues, the Committee was told that the Unrelated Bone Marrow Donor Registry has over 180,000 intended donors from across Canada. It was also told that the registry had few non-Caucasian individuals. In 1998, the UBMDR provided 44% of the donors required for Canadian patients; to date, it has treated nearly 900 individuals. The other 56% received marrow from international sources. Within 24 hours of a request, the National Search Coordination Centre can search the entire Canadian registry for potential donor matches; within 72 hours, it can search the 40 world registries.
The issue of structural accountability was mentioned in relation to both the British Columbia registry and the bone marrow registry. It was noted that the British Columbia Transplant Society, which is responsible for the registry, had recently changed its board of directors to reduce the number of medical/hospital representatives who appeared to have institutional interests different from those of the Society. The UBMDR is seeking clearer definition of its relation to the CBS and wants a secured budget, direct reporting lines, and greater separation of operations. The establishment of criteria to ensure accountability to all societal groups is another concern. For example, the ability of existing organ donor registries such as the one in British Columbia or tissue registries such as the UBMDR to attract diverse minority groups must be evaluated.
On public education and awareness campaigns aimed at increasing the number of statements of donation intent, the Committee heard about several endeavours. For example, the Canadian Association of Transplantation seeks to maintain strong public support for organ donation through efforts such as the Green Ribbon Campaign and occasional newsletters. The Kidney Foundation supports family awareness, promoting the importance of full and open communication within families. The common measures for evaluating public awareness campaigns were usually described in terms of number of publication copies distributed or level of recognition for particular symbols. Organizations representing physicians and nurses had little to say about professional education in support of increased intent to donate.
The Committee agrees with witnesses that clear accountability criteria and effectiveness evaluation must be part of the mandate for this and other program areas within the Canadian Transplant Network. Transparency and accountability might be enhanced through a requirement to provide annual public reports or to conduct a full review after a set number of years of operation. Establishing clear criteria to measure the performance of any data collection efforts or of any educational campaign is not easy, but must go beyond simply names or numbers of individuals aware of their existence. The Committee feels that any database and any public or professional awareness campaign must be monitored for effectiveness and appropriately adapted if required. This must involve clear measures of outcomes expected and achieved and evidence of adaptation to optimize effectiveness.
When used in Committee hearings, the term "standards" encompassed several different applications. One use that is particularly applicable at this stage of the donation/transplantation continuum is the reference to ethical principles or standards. In this context, witnesses referred to expressions of common values, many already ingrained in existing law and public policy. Data collection at this stage raised questions about the different interests and needs of donors and recipients and about requirements for anonymity, confidentiality, free and informed consent, and equitable access.
Related to the need for professional standards in database management, witnesses called for the development of guidelines to ensure that any data collection would gain and maintain national and international confidence. They mentioned the need for independent accreditation of any registry operations. Other witnesses referred to the need for medical practice protocols to protect an intended donor from premature procurement if admitted to a hospital setting in critical condition.
3. With the aim of addressing the preceding concerns about data, education, accountability and standards, the Committee recommends that the expert advisory group to the Canadian Transplant Network responsible for national oversight of individual intention to donate undertake the following general activities:
3.1 Monitor the progress and effectiveness of existing provincial intended donor registries with a view to determining any future national role;
3.2 Assist in the design and implementation of ongoing national public awareness and education campaigns with required evaluation; and,
3.3 Assist in the design and implementation of ongoing national professional education and training campaigns with required evaluation.
2. Expert Advisory Group on Donor Identification, Management and Procurement
Many witnesses used the term potential donor very broadly; however, the distinction between an individual who had signalled the intent to donate and a patient identified as a potential donor in a critical care facility is significant. Although the potential donor is the individual identified at the hospital, not every potential donor who has been pronounced dead and has suitable organs and tissues for transplantation becomes an actual or effective donor. Only when an individual's organs and tissues are actually extracted or procured for transplantation purposes does the individual contribute to the cadaveric donation data. The Committee heard that approximately 3% of deaths in hospital are brain deaths, and therefore appropriate to pursue as potential organ donors.
Witnesses noted that, in relation to cadaveric donation, Canada has reached a plateau at 14.4 donors per million population (pmp), a level it has basically maintained since 1993. Several witnesses confirmed that Canada's performance with respect to cadaveric organ donation is among the worst in industrialized countries, considerably poorer than those of the United States and Spain, who in 1998 had donation rates of 21 and 31.5 donors pmp respectively.
For many witnesses, the procurement stage is when a national database would be most useful and most cost effective. The collection of data on both potential donors (for organs, identified brain dead patients) and actual donors (organs and tissues procured and allocated) could clarify how many potential donors were lost to the system and for what reasons. Apparently, Spain undertakes this dual data collection, creating a potential or brain dead donor registry and an actual or effective donor registry. In Pennsylvania a system of required reporting of all deaths to a central registry produces a further variation on the theme of potential donors. In this instance the data collected are of all deaths occurring within a hospital setting and from this list the potential donors are identified and pursued.
The Canadian Organ Replacement Register (CORR), a program managed since 1994 by the Canadian Institute for Health Information (CIHI), focuses primarily on organ transplantation data but also collects retrospective cadaveric organ donation and waiting list data. It is a joint project funded by the federal and provincial governments with the support of the Canadian Society of Nephrology, Canadian Transplant Society and the Canadian Association of Transplantation. Transplant hospitals and organ procurement organizations contribute to the CORR database.
In considering the testimony given in regard to various possible organ and tissue registries, the Committee agreed that a database at this stage could be very cost effective. A comprehensive database to maintain records on all potential donors identified in hospital and on all actual donors would provide information to assess results. The Committee also felt that the CORR operated by CIHI would be a useful tool for the collection of the data on identified potential donors, which could then be compared to the actual donor database already maintained by CORR.
The capacity to develop a useful registry at this stage, when donors must be identified and maintained for successful organ and tissue procurement, largely depends on the ability of healthcare professionals to properly identify a potential donor in critical care situations. Professional education must include clear understanding and application of brain death criteria and proper and timely maintenance of a potential donor until a decision about donation is reached. Health professionals play a crucial role in public education through their interactions with the families of potential donors. Although it is to be hoped that these family members had prior discussions with the potential donors about their intent to donate upon death, nonetheless, it is imperative during this critical time that families fully comprehend such aspects as brain death and the organ procurement process in order to provide informed consent.
According to witnesses, inadequate education of healthcare professionals contributes to their failure to request donation at the critical care level in hospitals. A 1998 study of 15 Canadian hospitals indicated that, out of 232 potential donors identified, only 158 families were approached. This represented a loss of 31.9% potential donors. Another recent Canadian study revealed that 83% of nurses and 75% of physicians were reluctant to approach the relatives of potential organ donors, despite a generally positive attitude towards organ donation. It also suggested that only 35% of nurses and 55.4% of physicians knew how to refer organ donors.
Required request and required referral were both suggested as methods for ensuring that healthcare professionals approach families about donation. Required request would oblige the responsible person or team to approach the family and request consent to organ donation. Required referral (or required consideration, mandatory consideration, required reporting) would oblige healthcare professionals to report any individual that could be a potential donor. Witnesses argued that this could significantly increase the number of cadaveric donors identified each year. Both required referral and required request would involve legislative or regulatory change at the provincial level. Witnesses emphasized that either method must be accompanied by appropriate public and professional awareness and education campaigns.
The Committee agrees that education of health professionals is a continuing process and sees a significant role for professional bodies representing physicians and nurses. Beginning with a course work and curriculum focus on such elements as interpersonal communication and bioethics, reinforced through maintenance efforts at regular intervals, health professionals involved in critical care must be open to improved methods for approaching potential donors and their families. The Committee recognizes the significant increase in donor numbers that can result from improving the training of the involved professionals. On this, it sees the need for collaborative action by provincial, hospital and professional authorities to establish ongoing training programs aimed at educating the healthcare professional to identify all potential donors and to approach the next-of-kin.
Witnesses raised serious concerns about the need to ensure accountability in donor identification and subsequent procurement of organs and tissues on the part of health professionals, hospitals, procurement organizations and provincial governments. Without giving specifics, some witnesses referred to independent players operating outside any professional, institutional or governmental system, attributing the situation to a lack of official structure and leadership. Although the Committee was told that some regions of Canada consistently have higher donation rates than others, others have donation rates that fluctuate. It was suggested that the identification of commendable procurement practices could only be studied with confidence where rates are consistently high. This was one area where witnesses suggested the need for a national structure to examine what actually goes on, particularly to compare the performances of each province and make suggestions as to what is commendable and what does not appear to work.
At the professional level, witnesses reflected on the need to provide a clearer separation among the healthcare professionals who provide critical care, those who identify, maintain and procure organs and tissues, and those who carry out transplantation. Because most provincial organ procurement organizations grew out of local initiatives to procure in order to transplant, there is currently a close link between the procurement process and the transplantation process. A number of witnesses expressed the need to decouple the procurement process from the transplantation process in order to assure the public intending to donate that their critical care needs will never be jeopardized by the transplantation needs of another individual. The Committee agrees with the large proportion of witnesses who felt that, in terms of professional contact, the procurement process must be kept entirely separate from the transplant process. The Committee suggests that all programs in place, or to be established, ensure that the use of `procurement teams' for donor recruitment be completely decoupled from professionals involved in the transplant process.
At the hospital level, the Committee heard that, in addition to problems of recognizing a potential donor in the emergency room, ICU, or CCU, shortages of available beds in critical care or intensive care units limit the ability to maintain potential donors prior to organ procurement and to care for transplant recipients. The Committee agrees with the many witnesses who suggested that ways must be found to allocate specific funds to enable hospitals to overcome these limitations and ensure that the required beds are available for donation and transplantation purposes.
Although a few witnesses advocated financial or other sanctions, such as loss of accreditation or financial penalties for non-performance or non-compliance with donor identification, management or procurement, most argued that hospitals would achieve greater accountability if they were given some financial incentives. At present, donor identification in most provinces is seen as voluntary and covered under global hospital budgets. The Committee heard that hospitals must commit their own resources to maintain donors until organs can be recovered; a process that may cost an average of $6,000 above the insured costs for each procurement. Other countries have addressed this issue of hospital costs. For example, in the United Kingdom, 1,000 pounds can be reclaimed by a hospital that follows the correct procedures for procurement. In Spain, $8,500 US is provided in the hospital annual budget for each donor; this is calculated on the basis of donor and procurement rates from the previous year.
The Committee agrees with witnesses who felt that financial considerations discourage the identification of potential donors and it supports the need of hospitals to cover the costs of donor maintenance and procurement. This is an area where the provincial governments have responsibility for hospital budgets and some provincial government's, notably British Columbia and Quebec, have introduced programs to cover the costs of procurement. Witnesses noted that any additional obligations made over to the hospitals would have to be accompanied with the required funds as hospitals are currently financially constrained. The Committee would like to see a system of reimbursement for costs of donor management and procurement with appropriate allocations divided among all facilities.
Discussions at this stage touched on the issue of the conflict between ethical responsibility to individuals who had provided an early indication of their intent to donate and responsibility to grieving family members. In practice, healthcare professionals feel a need for next-of-kin consent despite knowledge of the potential donor's wishes. While a few witnesses suggested that family members should not have the right to override a person's wishes and that healthcare professionals had an obligation to follow through with an intended donation, most witnesses felt that it would be morally unacceptable to disregard the emotions of the grieving family. The Committee was told that participation of the family is essential for obtaining reliable answers on a medical/social questionnaire that helps to guarantee the quality and safety of the donated organs or tissues and that any procurement must involve family consultation and education. A small minority suggested that, once the patient has been declared brain dead, any subsequent actions taken with the body could be referred to as disposal of remains and as such, requires no family consultation. The Committee was convinced that the current custom of requiring family consent in order to proceed with the procurement process is the most prudent and that the emotions, beliefs, sensitivities or misgivings of bereaved families must be respected.
Another question was whether the earlier indication of intent by the now identified potential donor constituted truly informed consent. According to many, there is a requirement for all healthcare providers to obtain informed consent from patients or their next-of-kin for all types of treatments and procedures, including organ and tissue donation. There must be an interaction between caregiver and patient in which both agree about the treatment or procedure. Individuals or family members must have all the facts upon which to base an intelligent decision and must have the opportunity to ask any questions. There are three elements within informed consent: competence, disclosure/understanding, and voluntariness. An informed consent to donate, given by either the individual prior to death or the family at the time of brain death, would include knowledge about such elements as the concept of brain death, all procedures involved in maintaining the donor and in procuring the organs or tissues, and the anticipated fate of any organs or tissues. The Committee heard that informed consent is necessary and this may be the only stage when it can be obtained. In this respect it must be obtained from family and, in any professional training and education, the criteria for informed consent must be clearly outlined.
The Committee also heard several references to the system of presumed consent. This is a system whereby all persons are presumed to have consented to organ and tissue donation unless, at some time during their lifetime, they have expressed otherwise. It was suggested that, not only would Canadians resist such a system, there was no evidence from countries where this method has been enacted to show a substantial increase in organ donor numbers. In the absence of such evidence, the Committee could not envision an accountable medical or legal community adopting this approach.
For healthcare professionals, two types of standards - clinical practice standards and regulatory standards - were discussed. Witnesses suggested that clinical practice guidelines or standards that relate to the maintenance of donors or the procurement of organs and tissues would likely be developed either by individual hospitals or by medical and nursing associations. The goal of such protocols would be to assist practitioner and family decisions about appropriate care in the specific clinical circumstances. There was some discussion by witnesses of the need to legislate obligations for healthcare professionals with regard to donor identification. Witnesses suggested that measures such as required request or required referral could significantly increase the number of cadaveric donors identified each year and pointed to Pennsylvania's legislation and successes in increasing donor numbers. It was frequently suggested that an obligation in Canada to refer all potential donors, possibly to the regional OPO, would immediately increase donor numbers. Since hospitals are now expected to have a donor identification and organ procurement system, witnesses insisted that this requirement would add legal force but would seldom need to be applied.
While supporting the need for a uniform approach to reporting potential donors, the Committee recognized that any legislation requiring healthcare professionals to report falls under provincial legislation. British Columbia indicated that it has regulations that require immediate notification in the event of the death or impending death of a patient and require an approach to the next-of-kin. The facility must keep records of the notifications and must provide training for the healthcare professionals approaching the next-of-kin. Manitoba, Ontario, Nova Scotia, and Prince Edward Island also have legislative provisions for requesting permission from families. In light of the provincial nature of the legislative authority but recognizing the need for national uniformity in approaches, the Committee sees a role for a national body in monitoring such practices for effectiveness. It also suggests that the federal, provincial, and territorial ministers of Justice consider this issue at their next meeting.
Witnesses discussed institutional-based standards. In particular, accreditation standards for hospitals were seen as a key mechanism for ensuring that they were held accountable for their performances. Witnesses felt the need for assurances that there are ongoing reviews and monitoring of performances in procedures for identifying, managing and procuring within a hospital. In particular, relevant centres need to demonstrate that they have the resources and the teams in place to perform properly. Witnesses concerned about tissue procurement and banking expressed the need for an accreditation mechanism for organ and tissue procurement agencies. Currently, accreditation is obtained through the Eye Banking Association of America, the American Blood Banking Association, the American Association of Tissue Banks and is expected in the future from the Foundation for Accreditation for Hematopoietic Cell Therapy. The Committee accepts these suggestions for the use of accreditation as a means of monitoring procurement and proposes that the provincial accreditation bodies establish a category within the existing accreditation system that measures procurement performance for organs and tissues.
Beginning at this stage of the donation/transplantation continuum, witnesses expressed a need for regulatory standards to govern the safety and quality of donated organs and tissues. The regulatory measures proposed by the federal government are currently still in draft form. Developed as part of a standards process, the current effort is called the Canadian General Standard for the Safety of Organs and Tissues used in Transplantation (CGS) and is now with the Canadian Standards Association. The CGS is also to include subsets on specific organs and tissues. A number of witnesses involved in tissue procurement and banking referred to the lack of national standards and the difficulty in maintaining standards in the face of declining hospital funding. They indicated a need for dynamic national standards, adjustable to changes in technology and knowledge, and monitored by an expert committee. The Committee is concerned that the standards process is taking such a long time. Although initiated at least as early as 1996 and extensively developed, they are still being processed by the Canadian Standards Association. The Committee would like to see them move more quickly to a final stage when they can be referenced under the Food and Drugs Act and implemented nationally.
4. With the aim of addressing the preceding concerns about data, education, accountability and standards, the Committee recommends that the expert advisory group to the Canadian Transplant Network responsible for national oversight of potential donor identification, management and eventual procurement from actual donors undertake the following activities:
4.1 Facilitate the establishment of national databases on potential and actual donors utilizing the expertise of the Canadian Organ Replacement Register within the Canadian Institute for Health Information and relevant provincial organizations;
4.2 Assist in public and professional education initiatives, including recognition and support of donor families and professional training on approaches to families of potential donors;
4.3 Encourage the development of systems to monitor hospital processes and to initiate measures including appropriate incentives such as reimbursement for positive action;
4.4 Work with the F/P/T Conference of Ministers of Justice to evaluate mandatory request and reporting provisions under provincial Human Tissue Gift Acts;
4.5 Monitor the standards development, implementation and revision process and ensure the effectiveness of regulatory standards for organ and tissue procurement, storage, and testing; and,
4.6 Monitor standards and quality control mechanisms for laboratories.
3. Expert Advisory Group on Waiting, Sharing and Allocation
Two elements - waiting lists and allocation results - emerged in regard to data collection and assessment at this stage of the donation/transplantation continuum. The first focuses on the individuals waiting for organs or tissues and the second on the available organs and tissues and how they are allocated.
Witnesses told the Committee that the numbers on waiting lists for organs continue to rise, some estimated a 68% rise since 1991. In 1997, more than 3,000 Canadians were on a waiting list for solid organs, and over 140 died when no organ became available. Witnesses suggested that from 15% to 25% of those waiting for organs other than kidney and 6% of those waiting for a kidney would die without receiving the required organ. Data on deaths while on the waiting list are collected by CORR. It is unclear, however, whether these data include patients who died after being removed from the waiting list on the grounds that they would present too great a risk to transplant surgery. The Committee learned that, as the condition of patients deteriorates, some are never placed on the waiting list while others may be delisted until they have an acceptable chance at surviving surgery. The Committee feels that this is one area where CORR could collect more comprehensive data on deaths including those who had been delisted as well as those who did not survive long enough, or were never stable enough, to be placed on the waiting list. The status of these patients at the time of death should also be collected as this may affect reformulation of allocation algorithms. In addition, there could be further distinction within the waiting lists to show the number of patients awaiting retransplantation.
The Committee received less evidence about waiting times for tissues. Waiting time for corneas ranged from periods of approximately 3 to 6 months in Quebec and Ontario to 12 months to 2 years in British Columbia, Saskatchewan, Manitoba, and the Atlantic Provinces. The Committee feels that there are too few data available with respect to tissue; it sees a role for CORR in establishing a list of facilities that procure, store, and transplant tissue, and in supplying waiting lists for tissues wherever appropriate.
The issue of the national waiting list for recipients of extra renal organs, run for several years on a voluntary basis by MORE Toronto, was subject to scrutiny. Proposals to replace the ad hoc system of faxing out a weekly list with a different electronic cost-shared system to implement a real-time time list were stalled when consensus could not be reached by all transplant centres. The Toronto group argued that it could no longer afford to invest financial and human resources into producing the weekly list which has subsequently been taken over by MORE London. Witnesses asserted that there is a need for a real-time waiting list for solid organs in order to ensure their fair allocation and that funds need to be allocated to establish this as soon as possible. In addition, MORE Ontario suggested that its automated allocation database system could be used as a model and starting point for such a national list.
With respect to the allocation or sharing of organs and tissues, the Committee heard of inconsistencies between regions and of efforts to develop national algorithms for sharing organs and tissues. For organs in particular, a number of witnesses noted that clear allocation rules and guidelines were already developed or in the process of development. Beginning in 1991, organ-specific working groups were established, first for liver and then for lungs. For heart, kidney and pancreas, working groups to develop guidelines were formed in March 1999. The Committee is confident that the organizations entrusted with establishing and updating the allocation algorithms are well positioned for this task. It appreciates however the constraints that these groups have traditionally encountered and would like to see appropriate funding made available.
Some witnesses argued that the allocation of tissues between provinces was suboptimal. With respect to corneas, it was noted that certain areas of Canada have unacceptably long waiting lists for corneas (i.e. Nova Scotia, British Columbia) while other centres are able to secure an adequate supply (i.e. Toronto, Quebec). This discrepancy was related to the poor sharing of corneas between regions, partially attributed to different accreditation standards at processing and banking facilities. For example, British Columbia, despite its long waiting list, will not accept corneas harvested in Ontario. Allocation figures for one Ontario bone bank suggested that, of 41 cadaveric donors and 153 living donors of femoral heads, 724 pieces of bone had been distributed predominately in Ontario but also had been sent to Quebec, British Columbia, Alberta, Nova Scotia, Manitoba and Israel.
Witnesses saw an additional requirement for data collection on the locations and destinations of procured organs and tissues. This would permit assessment of the general outcomes of allocation as well as specific information on such variables as wasting, or non-use, of organs and tissues. For many, data collection and analysis are necessary to identify and change any deviations from or deficiencies in the algorithms. The Committee agrees with those who suggested the establishment of an oversight committee empowered to look at and to act on data results.
Witnesses explained that, if such data on waiting lists and subsequent allocations were collected and assessed, the results could be used for both public and professional education. For example, the information could be part of public campaigns to assure people that the criteria for placement and assignment of particular status to an individual on a waiting list are part of an open and transparent system. In addition, the same data could be used to reinforce professional education efforts aimed at appropriate utilization of waiting lists and subsequent allocations. Such data would also provide a consistent source of information for the healthcare professionals involved in creating and revising algorithms for sharing. The Committee feels that the data collected with respect to the allocation of organs and tissues should subsequently be used for public education aimed at establishing trust and confidence in the donation/transplantation process and for professional education in updating and adhering to algorithms.
The Committee heard about some aspects of the current allocation strategy for donor liver sharing. The criteria are revised yearly and consist of four dominant ones: medical urgency, location, matching (blood types A, B, and O), time waiting. There are also additional issues that are not included in the algorithm or numerical rules but may be considered as relevant such as the distance between the donor centre and the recipient centre, the physical size of the organ, and relevant attributes of the potential recipient. For medical urgency, there are specific classifications as follows:
- 4F Intubated patient in ICU with fulminant hepatic failure (FHF). Death is imminent.
- 4 Intubated patient in ICU due to severe liver disease but not satisfying definition of FHF.
Death is imminent.
- 3F Patient in ICU (or other CCU) due to FHF who has a high mortality risk.
- 3 Patient in ICU due to liver disease with one or more features of deteriorating liver function
(i.e. high serum creatinine or grade 3 encephalopathy despite therapy).
- 2 Patient in hospital but stable, or a patient with a liver tumour, or a patient waiting for a
combined liver/intestinal transplantation.
- 1 Patient at home.
- 0 Temporarily on hold (patient may be temporarily delisted because they may present too
great a risk for surgery).
Witnesses referred frequently to the need for allocation accountability, arguing that as a national issue, this requires national accountability mechanisms. They talked about the need for a national approach to ensure that allocation algorithms are properly used by individuals and organizations involved in the movement of organs from donor to recipient. Although some witnesses insisted that the most deserving patient always receives the available organ, others did not share this opinion. The Committee heard that, in the absence of a national structure, individual professionals and facilities set up informal telephone connections resulting in independent operations outside the system. Similar arguments were employed by witnesses in reference to tissues. For the Committee, national oversight in regard to allocation algorithms would ensure that the formulas are honoured.
The background to the development of the liver allocation/sharing guidelines is revealing. These existed only because liver transplant physicians and surgeons saw the need for sharing mechanisms for high status patients and the requirement for consistent listing criteria required by such a sharing system. The guidelines were developed without governmental authorization or assistance; the working group relied on volunteerism from liver physicians and surgeons and transplant coordinators and financial support from pharmaceutical companies.
The Committee heard from the Canadian Coordinating Office for Health Technology Assessment (CCOHTA) about its study on current criteria for adult recipient selection for heart, kidney and liver transplantation. CCOHTA noted that, although the centres generally practise similar methods of listing patients nationwide, they vary in the degree of importance given to certain criteria for patient listing. For example, some centres indicated that age or employment status were very important in decision making while others said they were not important. There were also differences among organ groups. Thus, while alcohol and illicit drug abuse were significant for heart, kidney and liver centres, tobacco use was very significant to heart. Heart programs also had a firm requirement for social and community support while kidney programs did not see these as vital. The Committee would like to see greater uniformity in listing criteria among Canadian centres.
The export of organs and tissues outside the country also raised questions of accountability on the part of institutions that participate in such practices. For example, the Committee heard that, in some provinces, companies from the United States are purchasing tissues in order to sell them in the U.S. It was observed that when demand for tissues is low and donation rates are high, money can be made by regional institutions that sell the tissues. The Committee feels that the ability to collect, monitor, and share data on organ and tissue allocation will diminish and ultimately eliminate the unnecessary export of organs and tissues out of the country.
The Committee was interested to learn about a particular service offered by l'Association canadienne des dons d'organes that assists the provincial allocation process in Quebec. This not-for-profit organization committed to public awareness began in recent years to provide emergency service for transporting donated organs. For this purpose, it supplies fully equipped emergency vehicles but relies on the volunteer services of 2,000 police officers. Through close ties with Québec Transplant that directs calls from its coordinators, l'Association canadienne des dons d'organes provides the transportation link between hospitals and airports (or between hospitals) for the organs and medical teams. Funding for this project derives primarily from The Mutual Group and the Canadian Tire Foundation of Quebec supplemented by donations. The Committee would like to see further analysis on the possibilities for expanding this service throughout Canada. In particular, it is interested in the idea of partnerships with the private business sector.
The concerns of witnesses in relation to ethical principles or standards included questions about the assurance of confidentiality around data collection and the need for anonymity between donor and recipient. The Committee recognizes that data privacy issues are far reaching and seeks assurance that every precaution is taken, including consultation with federal and provincial privacy commissioners.
Several witnesses referred to ethical concerns that arise out of allocation decisions and the need for equitable access to allocated organs and tissues. Several emphasized that donated organs are not an unlimited resource and therefore transplantation cannot be compared to other healthcare issues. They questioned whether there are situations where different treatment of potential recipients could be justified. For example, they mentioned individuals who had a history of smoking, drinking or drug use; who were not permanent residents; or who were seeking retransplantation. The Committee trusts that the organ-specific groups will consider fairly all such concerns in their formulation of allocation algorithms.
Although witnesses talked about standards related to organ and tissue allocation, it was unclear whether they were referring to the need for professional standards or for regulatory standards. They pointed to the need for standards of allocation or sharing algorithms specific to each organ and tissue and the need for accreditation processes that recognized the criteria for transporting and storing organs and tissues. Many tissue banks indicated that allocation of tissues between regions requires recognized accreditation but that such accreditation is difficult for many facilities to attain due to the costs involved. In addition, some witnesses argued that consistency of allocation standards between provinces could provide clearer criteria for the `cross-border flow' of organs and tissues. It was suggested that properly implemented and monitored allocation standards would foster stronger nationwide sharing. The Committee agrees that the mandate of the national body should provide a strong oversight capacity to ensure adherence to allocation rules.
5. With the aim of addressing the preceding concerns about data, education, accountability and standards, the Committee recommends that the expert advisory group to the Canadian Transplant Network responsible for national oversight of waiting, sharing, matching and allocation undertake the following activities:
5.1 Facilitate the establishment of a national real-time waiting list for all solid organs such as heart, etc.;
5.2 Assist in public awareness and professional education and training initiatives;
5.3 Monitor the development of sharing algorithms for allocation and any mechanism for enforcement of sharing; and,
5.4 Provide a tracking system for information and encourage policy development on the import and export of organs and tissues.
4. Expert Advisory Group on Transplantation Outcomes
Witnesses noted the need for multi-faceted collection and assessment of data for organ and tissue transplantation. The general public as well as healthcare professionals and policy makers want to know who receives transplants of organs and tissues, what organs and tissues they receive, where the procedures are done, how the procedure affects the presenting medical or health problem, and whether there are any unexpected adverse effects.
Currently, the Canadian Institute for Health Information (CIHI) assembles retrospective transplantation statistics for organs. According to its database, 1,578 organ transplants were performed in Canada in 1997. This represents an increase of total transplants by almost 45% since 1986, largely reflecting increases in extra-renal transplants. Proportionately, kidney transplants have increased less than those for other solid organs. The Committee heard, for example, that since 1981 there have been more than 2,000 heart transplants performed in Canada, to an average of 160-180 transplants per year.
For tissue information, there is no database equivalent to the CIHI one for organs. It is not possible to obtain information on the numbers of tissue grafts performed; the amount of donated tissue; how much was used, banked or disposed of; or which facilities are performing the procurements and transplants. A number of witnesses from tissue groups expressed a desire to be a part of CIHI's statistics-gathering efforts. Evidence provided on recent corneal transplantation showed a yearly range from 40 to 50 corneal transplants in Saskatchewan and Manitoba to 1,000 corneal transplants in Ontario.
The Committee sees several ways that the CORR program could be enhanced. For example, it could fill some gaps in the collection of data on children, particularly data on locations and outcomes of pediatric transplants. It could maintain lists of the number and frequency of retransplantation of solid organs, and if appropriate any tissues. It could establish a database on tissue transplantation, facilities and outcomes.
The Committee was told of the perception, among both the general public and healthcare professionals, that organ transplantation is still an experimental procedure. There was some discussion of the fact that, although many transplant procedures are now considered to be standard medical practice, others are still investigational. Particular reference, for example, was made to the use of reproductive tissues in fertility procedures and to fetal tissue use for Parkinson's Disease. Witnesses suggested that transplantation, like other medical practices, could benefit from clear information gained through cost and practice evaluation. This could, in turn, be shared with both the public and the broader healthcare community.
From the Committee's perspective, these concerns over effectiveness and efficiency in transplantation should be addressed in public education campaigns and in professional training programs. The public needs to know what works and what does not work in relation to transplantation. In addition, healthcare professionals need to know when they are working in the realm of standard practice or experimental procedures. Results from the evaluation of transplantation outcomes should be readily available to the public and to professionals. For healthcare professionals involved in any stage of the donation/transplantation continuum, such information could be part of well-designed continuing education and training opportunities.
The Committee would like to extend a special acknowledgement to the numerous individuals who as recipients or members of donor families along with multiple provincial and national organizations, already take an active role in the education of both the general public and healthcare professionals about transplantation.
In transplantation there are many players ranging from provincial governments through hospital or clinic facilities to healthcare professionals. For each transplantation, it is not only important that the public know what groups are responsible but also that the groups recognize what outcomes are expected from them.
Witnesses frequently raised the cost effectiveness of organ transplantation when compared with alternative medical measures. They cited the $19, 500 for the hospital costs associated with a kidney transplant versus the $50,000 per year for maintaining an individual on dialysis. They also pointed out the significant difference in an individual's quality of life after kidney transplantation. However, it was also noted that, from a health system perspective, dialysis savings are not immediately realized because as soon as patients are removed from the program, others from the dialysis waiting lists immediately take their place.
When asked about other types of transplants, witnesses noted that no life-sustaining alternatives equivalent to dialysis exist. As they also pointed out, determining an average cost for any medical procedure is an inexact process and one tackled over several years by the federal/provincial Coordinating Committee on Reciprocal Billing. The CCRB looked at interprovincial billing rates for transplants, rates that were inclusive of the hospital per diem, but not of the physician fee-for-service, for an average length of stay for each procedure. It suggested the following organ transplant billing costs: $111,120 for heart and lung combined or just lung alone, $82,400 for liver, and $75,220 for heart. For tissues, specifically bone marrow, they provided two costs: $33,400 with a 48-hour discharge (autologous) or $80,400 for all other cases.
Of the provincial government representatives who appeared before the Committee, few focused on the transplantation end of the continuum. Consequently, the Committee did not receive substantial data about physicians' fees for surgical procedures or the costs absorbed by recipients. Only passing reference was made to the fact that some provinces provide limited coverage for such things as anti-rejection drugs, frequent follow-up visits, transportation and costs for away-from-home treatment. The Canadian Pharmacists Association provided an Ontario study showing costs of over $500 per month for the anti-rejection drug, Cyclosporine, that must be used for the individual's lifetime. This organization called for a national pharmacare plan to cover medically necessary drugs.
From the facility and medical practitioner perspective, some witnesses pointed to efforts to evaluate transplantation through assessments of survival rates. Witnesses commented that one-year rates for organ transplants have increased with the advancement of anti-rejection drugs. The best rates are associated with kidney transplants from living-related donors while the lowest rates are observed for recipients of lung or heart-lung combinations. The following describes an example of one-year survival rates as provided to the Committee: living-related kidney (98%); cadaveric kidney (95%); liver (90%); heart (85%); pancreas (79%); small intestine (70%); multi-organ (70%); lung (65%); heart-lung (65%).
Several witnesses noted that, without any requirements for transplant facilities to provide their success rates for procedures, these facilities are not held accountable for their performance. Such success rates could include not only survival, but also other measures such as quality of living, activity of daily life, social productivity, etc. Other information could highlight the incidence of cancer which has been linked to some anti-rejection drugs. In addition, the Committee did not have the opportunity to hear from representatives of provincial colleges responsible for licensing physicians and nurses or from provincial hospital associations. Nonetheless, it did hear that witnesses see these groups as being the ones accountable for ensuring the best possible transplantation outcomes.
For the Committee, accountability at this stage of the donation/transplantation continuum is crucial to ensuring full public support. A national perspective on transplantation outcomes would involve measures of survival at various intervals, of quality of life, and of repeated medical and surgical interventions. In addition, the Committee feels that the attempts at measuring cost savings are misleading without the inclusion of other variables such as the number of patients requiring retransplantation.
In ethical terms, witnesses called for equitable access for all Canadians. They focused on issues of age, gender, ethnicity, geographic area, economic status, and health status. They wanted assurances that the transplantation procedures would do more good than harm both in relation to extending an individual's life as well as providing good quality of life. They also expressed the view that the individual good achieved for the recipient must be balanced against the collective good of the broader society. This was particularly in reference to the issue of the transfer of infectious diseases through transplantation. The Committee sees an oversight role for the Canadian Transplant Network, to ensure that transplantation services are accessible and beneficial to all Canadians.
In regard to professional guidelines or standards, witnesses discussed accreditation for hospitals and licensing standards for physicians. They called for the establishment of clear standards to measure and monitor outcomes of both hospital and physician procedures and protocols. In addition, they emphasized the need for recognition of potential conflicts of interest between the care for a patient who might become a potential donor and the care of a patient hoping to become a recipient. The Committee wants accreditation of transplant facilities to be based upon their establishment of and compliance with standard protocols as well as their regular reporting of transplant outcomes.
On the regulatory standards, most witnesses referred to the development of the Canadian General Standard for Safety of Organs and Tissues for Transplantation (CGS) and its specific organ and tissue subsets. The Committee was asked to assume that these standards are adequate and will be efficiently implemented, a difficult position to take in the absence of evidence. It notes with concern that formalizing the CGS has already taken several years and urges that the process be completed as expeditiously as possible. The Committee recommends that the Canadian Transplant Network accept an oversight role in ensuring that these standards are effective. In particular, the Committee wants to ensure that adverse outcomes related to transplantation safety and quality are publicly recorded and that corrective actions are taken if deemed necessary.
The other area of regulatory initiative touched on in the hearings was the Canada Health Act and the monitoring of the principles of accessibility, universality, portability, comprehensiveness and public administration. Portability was mentioned by the CCRB in its agreement on billing rates, but the Committee heard that comprehensiveness in relation to some tissue procedures (i.e. reproductive) might not be adequate. The Committee recognizes that establishment of a Canadian Transplant Network should be accompanied by an agreement between provinces on reciprocal billing around tissues as well as organs. It also suggests that continual assessments of the application of the Canada Health Act principles in relation to organ and tissue transplantation are important.
6. With the aim of addressing the preceding concerns about data, education, accountability and standards, the Committee recommends that the expert advisory group to the Canadian Transplant Network responsible for national oversight of transplantation outcomes undertake the following activities:
6.1 Facilitate the establishment of a national database to track transplantation outcomes utilizing the expertise of the Canadian Organ Replacement Register within the Canadian Institute for Health Information;
6.2 Coordinate the development of public education and awareness programs employing recipients;
6.3 Monitor professional performance and practice outcomes and assist in the development of related professional education and training; and,
6.4 Establish a monitoring mechanism to assess whether the Canada Health Act principles apply and are enforced in the area of transplantation of tissues and organs.