HEAL Committee Meeting

STANDING COMMITTEE ON HEALTH

COMITÉ PERMANENT DE LA SANTÉ

EVIDENCE

[Recorded by Electronic Apparatus]

Tuesday, March 23, 1999

• 0911

[English]

The Chair (Mr. Joseph Volpe (Eglinton—Lawrence, Lib.)): Colleagues, ladies and gentlemen, welcome to one of the final sittings of the Standing Committee on Health's study on the state of organ and tissue donation in Canada. This study has been ongoing since the House resumed in early February. We had some preliminary discussions prior to that in December.

Today we are pleased to have as witnesses a panel of national and international experts in the field. I am especially pleased to extend a hearty Canadian welcome to the following individuals: Dr. Blanca Miranda, the national transplant coordinator from Organizacion Nacional de Trasplantes, in Spain; Carol Beasley, managing director from the Partnership for Organ Donation; Dr. William Pfaff, the president of the United Network for Organ Sharing; and Elizabeth Barker, co-chair and director of acute care programs, Nova Scotia Department of Health, co-chair of the National Co-ordinating Committee on Organ and Tissue Donation and Distribution. Ms. Barker is accompanied by the other co-chair, and professor of urology at Dalhousie University, Dr. Philip Belitsky. We also have Prudence Taylor, project team leader, Health Strategies Division, Alberta Health. We also give a special welcome to Madam Celia Wight from Eurotransplant Donor Action Foundation in the U.K.

To each and every one of you we give a special welcome. We've reserved an interesting parliamentary procedure for you to experience while we are here. The House of Commons, which is about 50 metres down the road, will be opening its doors in approximately 50 minutes. At that time it will immediately call members to the House for a vote. That call will last for 30 minutes, and all members of Parliament are required to be there for the vote.

We have asked the whips from the relative parties to consider pairing off some of the members on this committee. They may accede to that request, but more likely than not they won't. In the event they do not, I will suspend for about 15 minutes while members move forward to vote, and you will be engaged by the secretariat you see at the head of the table here.

We will ask you for your patience. It's not something we planned, although we did plan something you saw when you came into town yesterday, and that was a typical example or snapshot of a Canadian winter, for those of you who have already started to enjoy spring.

• 0915

Without much further ado, I'll go into the basic parameters. I'm not going to see the clock as religiously as I have in the past. Typically we ask our interveners to give us presentations of about five minutes each. When all presenters are finished, we go into questions and answers from opposition members and government members. If you feel you need to go beyond five minutes, keep in mind I'm looking at a clock, but all members are anxious to hear everything you have to say.

Let us start with Dr. Blanca Miranda.

Dr. Blanca Miranda (National Transplant Coordinator, Organizacion Nacional de Trasplantes): Thank you. Good morning, everybody. First of all, thank you very much for inviting me to be here.

Very briefly, I will explain to you the Spanish organ procurement system.

Spain is a European country. We have nearly 40 million inhabitants and 17 autonomous regions. The national health system is comprised of all the facilities and public services devoted to health. Today, public health assistance is available for 99% of the population.

The National Transplant Organization started in 1990 and is attached to the Spanish Department of Health. The organ procurement system has been built on the basis of three main points: the legal, technical, and organizational aspects.

The legal framework is probably no different from other legal frameworks. It covers aspects like brain death diagnosis or certification, consent and the need for trust, the need to avoid trade and commerce, and the criteria for official authorization and accreditation. The scope of the organization is national. It is medium-sized, with 40 million inhabitants. We report directly to the national ministry of health. Our philosophy is to work in a decentralized way. Every region must be responsible for their successes and their downfalls. Our main aim is organ procurement.

Our responsibilities as a national organization are organ donation and procurement promotion, sharing, and sustaining and maintaining the database. The activities include solid organs, tissues, and bone marrow.

From the very beginning it was presumed that a shortage of organs was the principal limitation to organ transplantation. We thought the problem was probably not the absence of suitable donors, but mainly the failure to convert potential donors into actual donors. We tried to emphasize the need for a person or a group of persons to be responsible for the organ and tissue procurement in each hospital accredited and authorized for organ procurement.

The national transplant coordinating network was conceived at three levels: national, regional, and local or hospital. We think we have a developed a flexible management structure that ensures the transplant coordinators who work at the grass roots have a sense of involvement and accountability for performance. Most of them are qualified doctors, mainly intensivists or nephrologists who are dedicated only part-time to the transplant coordinator. The coordinators report directly to the hospital medical director and not to the chief of the transplant unit.

Since 1990 the organ donation rate has doubled in Spain, from 14.3 donors per million population to 31.5 donors per million population in 1998. Not only has the number of donors risen, but also the number of organs retrieved and grafted. So this means the number of organs grafted is three times the rate it was in 1990.

• 0920

In summary, the Spanish organ procurement rates have resulted from the efforts to overcome different obstacles, such as the untrained or under-trained staff, the unidentified donors, and the reluctance to approach grieving families. This means we have professionalized organ donation with the need of an organization, focusing on promotion and facilitation of organ donation mainly, and not only on organ transplantation or sharing. Spain has made progress in the organ donation field, but I think we have much more to achieve in the future.

This covers the general overview. I will be ready to answer your questions about different items such as budget or the organizational aspects more deeply.

The Chair: Thank you, Dr. Miranda.

Let me go to Celia Wight.

Ms. Celia Wight (Manager, Donor Action Foundation): Thank you very much for the kind invitation to address you here today. It's a great privilege to be here in Ottawa.

Donor Action takes a systematic approach toward organ donation and brings together best practices from Spain—you've just heard from Dr. Miranda about some of the salient points of the Spanish organ procurement system; the partnership for organ donation based in Boston, United States; and other initiatives from the Eurotransplant Foundation in central Europe.

The program takes a systematic approach and is targeted at intensive care units. The program identifies how many potential donors there are in any given intensive care unit and how many are missed. It identifies why potential donors are missed. It provides corrective measures we think can help increase organ donation rates.

It starts with a diagnostic review within intensive care units to identify the strengths and weaknesses in the donation process. It provides customized hospital protocols to fill specifically identified gaps, and it aims to place the responsibility for organ donation on the key staff who are allocated at the point of donation—that is, intensive care units.

At the diagnostic review, it takes the form of a retrospective medical record review and an attitude survey of doctors and nurses working within the intensive care units where the medical record review is being carried out. It provides a customized donor action system database to analyse these data and put them together to create a profile and baseline information of practices within the intensive care unit. This database, following the retrospective diagnostic review, can be used as an ongoing monitoring tool to monitor progress.

The customized aspects of the program, the remedies, and the corrective measures follow the five main steps in the donation process: the identification of a potential donor; the referral of a potential donor to the appropriate coordinator or organization; the care of the family throughout the complete process; the management of organ function in the brain-dead potential donor; and the retrieval of organs. All these make up a successful donation.

The final development of the program was carried out in selected intensive care units throughout the world. There were six intensive care units in Canada, two in Spain, two in the Netherlands, and one in the United Kingdom. These were type one, type two, and type three intensive care units, so there was a full experience of the different types.

There was a retrospective medical record review. Then a hospital attitude survey of the staff looked at their knowledge and attitudes toward organ donation, their self-reported confidence in dealing with donation-related issues, the support they felt they received during the donation process, their educational requirements, and their actual educational experience.

• 0925

These data were put together, and the summary observations we found from the pilot data were that the medical record review can effectively identify donation potential and areas for improvement. Intensive care staff support organ donation. They think it's a good thing and they think it saves lives. But they feel increasingly uncomfortable when performing key tasks close to donation. But when matched together, the medical record review and the hospital attitude survey can be used to customize the donor action modules—which, as I explained before, cover the donation process—to the individual intensive care unit's needs.

The effect we've found so far is that the pilot evaluations identified among the hospitals that were involved a 42% loss of potential donors. Either they were not identified, or there were management problems during the process. But the introduction of a project or process such as the donor action program does increase organ donation initially from about 30% up to 120%. That is an immediate effect of an intervention. But sustained improvements over two years tend to settle at around 15% to 30%.

In conclusion, we feel that this project is a unique opportunity to increase organ donation. It has a high probability for success, but for ongoing success it does require goodwill, resources, and commitment and a cohesive national, provincial, or local management structure. The aim is to provide an ongoing and sustained increase in organ donation.

Thank you. I'd be very happy to answer any questions you have.

The Chair: Thank you very much, Ms. Wight.

We'll now go to Carol Beasley.

Ms. Carol Beasley (Managing Director, Partnership for Organ Donation): Thank you very much. I would like to thank the members of the Standing Committee on Health for the opportunity to speak today.

I represent the Partnership for Organ Donation, a U.S.-based, non-profit organization dedicated to increasing organ donation. We provide assistance to hospitals and organ procurement organizations to improve their donation effectiveness. We conduct and publish research on the donation process, and, as Celia Wight has already explained, we are members of the Donor Action initiative.

Our organization believes donation will be maximized when the public is committed in advance to donation and when hospitals and procurement organizations have adopted optimal donation practices. Given that we already enjoy very high levels of public support for donation, we believe the major opportunity for improvement resides in hospitals.

I would like to share some findings from work we have done in Canada. Over the past four years the partnership has carried out significant project work in Canada, and I will share selected findings that shed some light on the current donation situation here and point to some opportunities for improvement.

As Celia has explained to you, we are members of Donor Action. We do significant diagnosis work, which is where we started in Canada. We started in 1996 doing medical records reviews in 15 hospitals in four provinces: Alberta, British Columbia, Ontario, and Quebec. The aggregate findings were as follows: In these 15 hospitals there were 232 medically suitable potential donors identified, of which only 40% actually became donors. So the minority of them became donors. The major reason for non-donation in these hospitals was failure to ask the family to donate, which occurred 25% of the time. Other reasons for non-donation were denial of consent, accounting for 20% of the cases, and non-identification of the patient as a potential donor, which occurred 7% of the time. There were a small number of other reasons donation did not occur.

We also examined the readiness of critical care staff to respond to potential donor situations by means of a survey, which Celia Wight has already referred to, in nine hospitals in three provinces. Those were Alberta, British Columbia, and Ontario. The vast majority of physicians and nurses supported donation. However, most had little or no training in critical donation skills. The most widespread training was in clinical management of the brain-dead patient, with only 38% of physicians and 22% of nurses reporting training. Training levels related to family communication and coordination of the donation process were even lower.

The diagnostic projects depict an organ donation system that has significant potential to improve through more consistent identification of potential donors and adopting optimal practices for requesting donation from all families. Hospital staff strongly approve of donation, but most lack sufficient training to be effective in this highly sensitive role.

• 0930

On the basis of diagnostic findings such as the ones I have just described, Capital Health in Edmonton proceeded with a project designed to actually strengthen hospital donation systems. The three participating hospitals are the University of Alberta Hospital, the Royal Alexandra Hospital, and the Grey Nuns Hospital. The co-chairs of the donation committee, which provides oversight to the project, are the chief operating officer of University Hospital and the chief of neurosciences, reflecting the reality that donation depends on the activities of critical care professionals, not transplant surgeons.

The work has four objectives: one, the development of an evidence-based practice guideline for communicating with families; two, definition of a family support role for potential donor families; three, in-depth education; and four, quality assurance and outcome monitoring.

Performance goals are to attain 100% identification of all potential organ and tissue donors and 100% requesting of donation from families in accordance with the practice guideline. If these two goals are attained, we expect the donation rate to increase. The new guideline is scheduled to be fully operational at University Hospital in May, and it will be phased into the other two hospitals over the following couple of months. By the end of 1999 there will be preliminary data available to assess how well the hospitals are adhering to the new guideline and whether donation rates are in fact improving.

This model takes advantage of insights from the in-depth diagnosis of the participating hospitals as well as the example set by ONT, the Spanish organ donation organization. Similar to the Spanish model, responsibility for the identification of potential donors and the coordination of family communication regarding donation is assigned to a small trained team that is based in the critical care departments.

Based on the work of our organization in Canada, I will comment on the opportunity facing the federal government to improve organ donation effectiveness in this country. Our experience suggests the need for a national donation framework with national oversight, yet one that recognizes and adapts to regional differences. Responsibilities of this national entity could include:

(1) Establishing consistent measures of performance and providing data on donation performance that is reliable and comparable across regions. This would allow regionally based organizations to benchmark themselves against the rest of the country and develop appropriate action plans locally.

(2) Fostering accountability by hospitals and procurement organizations for donation results. Existing hospital accreditation structures could be used for this purpose. Procurement organizations should also be subject to national accreditation standards.

(3) Assigning appropriate resources to organ donation activities especially in hospitals. Given that kidney transplants save money over the long run, it should be possible to fund a greater investment in organ donation. What I mean by this is an investment in organ donation readiness on the part of the key critical care staff, who are the ones who facilitate donation happening.

(4) Defining standards of practice or consensus approaches to organ donation, including practice recommendations, national training curricula, and certification mechanisms.

The committee has also heard recommendations advising the establishment of a national transplant entity with responsibility for transplant safety standards, centralized listing of transplant candidates, and more coordinated approaches to organ allocation. I would suggest to the committee that it is important to remember that donation and transplantation are distinctly different disciplines, with different challenges and performance measures and involving different professionals in most cases. If the government decides to proceed with a national agency of some kind, it is essential to design it so that donation initiatives and transplant issues do not become too entwined. Otherwise, there is a risk that donation will become the stepchild of transplantation, and little progress will be achieved.

The committee is to be commended for taking such an in-depth and careful approach to a very complex issue. Based on our organization's experiences working with the critical care, organ procurement, and transplantation communities in Canada, we believe there is tremendous willingness to take effective, well-grounded steps to increase organ donation. With a commitment to an appropriate level of federal involvement and the mobilization of necessary resources, you will undoubtedly be successful.

Thank you.

• 0935

The Chair: Thank you for ending up on such a positive note for what the committee is going to be capable of doing.

Dr. Pfaff.

Dr. William W. Pfaff (President, United Network for Organ Sharing): I've provided you a written comment and I'm going to simply take some of the salient points from that in a brief introduction.

My name is Dr. William Pfaff. I'm a professor emeritus of surgery at the University of Florida. I've had a 34-year interest in transplantation—actually 35, but we didn't start right away.

Much of what I've written on and am going to talk about, which I continue to talk about in our own country, is about variations. Solving the problem of transplantation is an admixture of rather complicated matters, some of which I can't answer for. This includes the incidence and prevalence of diseases that are likely to bring a patient to the need for transplantation. In our country, kidney disease varies with racial demographics. The incidence of end-stage renal disease is three to fourfold higher in all age groups in African Americans when contrasted with the Caucasian population.

Liver disease, I've learned only recently, is a product of the southeast and southwest; there's a much higher incidence of liver disease in those populations. This is something I didn't think existed. I'd thought that end-stage liver disease was largely the product of northeastern sin, of which we are free in the southeast, or generally so. But there are dense pockets in those states of end-stage liver disease, wherein the cause of death is liver disease. And you could refer to that in the Centre for Disease Control website. I've found it a very valuable resource.

Heart disease of course is ubiquitous. Diabetes is really both genetic and sporadic, so the incidence and need for pancreas transplantation is going to vary. Lung disease is diffuse because of its many causes. Certainly those of you who are in Ontario are aware that one of the major developments of lung transplantation took place there. I don't know whether there are a greater number of smokers in Toronto or not.

There is variation in patient access to transplantation services, and I have little knowledge of that in your communities. I don't know if transplantation is uniformly available. From conversations I had this morning, I gather that in some provinces liver transplantation is not, and one must seek care in adjacent areas. I don't know if there are financial barriers to transplantation. There certainly are in the United States of America. And there is a high variability even in the provision of Medicaid, a program for our most needy, in coverage for extra-renal transplantation. It varies by state. In general, children are provided for, while adults may or may not be. There is also a need for post-transplant immunosupressive costs, which can run as high as $10,000 or $11,000 a year.

One has to ask if there are specialists to maintain patients awaiting transplantation, particularly those who are going to be served at some distance from their home. The art of maintaining a patient who's awaiting a heart transplant is a high art. Patients with liver transplantation can ebb and flow in their need and urgency for that care.

I should also comment that there are aggressive and conservative medical practices. There are those who would favour transplantation with a low but real probability of outcome, and others who would say you should reserve the use of such organs for those who are likely to most benefit. So we have had long discussions regarding equality and access to care, versus the principle of utility, which is the best use of a scarce resource, and that would be measured in years of patient graph survival thereafter.

Organ donations rates vary worldwide. You've heard that already. In the United States, in 1966, the range of our then 63 organ procurement organizations was 14.7 donors per million to 37.4 donors per million. Actually, the program that was 37.4 in that year did 40 donors per million this past year. Is there an acute management system for individuals who were involved in motor vehicle accidents? They provide in our country probably now about 30% of all donors. On the other hand, if somebody is at quite some distance from an acute care hospital and an intensive care unit system, they are not going to become a donor because they are going to die at the roadside. The same applies to the acute management of patients who undergo cerebral vascular events.

• 0940

Is there an incidence of motor vehicle accidents in your urban area that's similar to ours? I've only witnessed a small number of drivers from Ontario or Quebec, who descend through Florida every spring, winter and fall. I haven't noticed that they drive more or less responsibly, but you can tell me that. There has been a change in the incidence of motor vehicle accident deaths in our country, with the greater usage of seat belts and other safety measures.

The demographics of the United States to some extent dictate the incidence of permission. In our own organ procurement organization, permission is granted about 68% of the time in our white population, and only 37.4% in our black population. The features that are associated with the probability of donation also relate to the education and financial prosperity of the potential donor and his or her family. So those demographics also play a role.

The make-up of our organ procurement organizations varies mightily, I believe. It's a question of an unceasing pressure to reduce the cost of medical care in our country, which is, at least as a proportion of gross domestic product, substantially higher than yours. It's something I don't fully understand; I never have.

But certainly over the last several years, with the impact of managed care in our hospitals and other health delivery sites, there is a great urgency to reduce cost. This may mean that we fail to invest sufficiently in the resources necessary to conduct a very highly productive organ procurement organization. It takes time, money, and professional individuals who are dedicated to that purpose.

I differ a little bit with what Carol just told you in terms of the integration of organ procurement organizations and transplant programs. I think their integration has always been, and should be, nearly complete, and that our interaction with one another is one of the important features of those organizations that are most successful.

Thank you.

The Chair: Thank you very much, Dr. William Pfaff.

I'm going to go immediately to questions, and I caution colleagues that we will be interrupted. Apparently the whips are going to insist on giving our guests an indication of how parliamentary procedures operate. Keep in mind that we have five minutes and we'll get back to you on a second round. So when I say stop, we'll stop.

Mr. Grewal.

Mr. Gurmant Grewal (Surrey Central, Ref.): Thank you, Mr. Chairman.

Let me take this opportunity to welcome all the witnesses who have taken time to appear before the committee, and for their excellent presentations.

I'm intrigued by the success of the Spanish model, so my question will be to Dr. Miranda. One of the options that has been proposed to this committee in the past included starting up a national organ registry. I'm surprised that Spain has chosen not to maintain a national organ donor registry. Why is that?

Dr. Blanca Miranda: We think a donor registry is something that has to be asked for by the general public. By itself, probably, it would not solve any problems. We do not believe that any law or any registry would solve any problems, since, as has been said before, the problem is within the hospitals and not exactly within the population.

So a donor registry is something very expensive and something that will probably not have large results in regard to the actual organ donor rates. For instance, in the Swedish registry, which is probably one of the best that has been set up in the recent past, only 20% of the population has been registered. The cost of the Swedish donor registry is $1.50 per person, per inhabitant, and per year, without including what's disseminated in information to the general population about what the registry is and all the campaigns to inform the general population about how to use the registry and so on. So it costs $1.50 per inhabitant just to maintain the computer system of the registry. And then if you need to look up something in the registry only 20% of the potential donors are registered. In the rest of the cases you have to go to the families and ask the families about the willingness to donate or the position of the family if the position of the deceased is not known. So I think the cost-benefit ratio does not support the idea of having done a donor registry.

• 0945

If you impose a donor registry as a presumed consent law strictly applied, then you have to be sure that the population would support this idea. At least in Spain, from our surveys we are sure that only 20% to 25% of the population would support the idea of a registry and the presumed consent application of this registry, strictly speaking.

Mr. Gurmant Grewal: That leads to the next question, actually. What elements of the Spanish model would be completely transferable to a Canadian format? And you also mentioned cost—what are the costs of the Spanish model?

Dr. Blanca Miranda: For the overall costs, it depends. If you speak about the overall costs of organ donation, on the whole it's not more than 10% of the overall costs of transplantation programs. And for the hospitals' donation processes it's about $11 million or so per year. It's $8,500 per donor, which is allocated in the hospital budget. For the national organizations, for the national office, for the national structure, including the training programs and all the database management, all the programs and so on that are carried out by the national office, it is $1.6 million yearly. And for the regional offices it's $1 million a year. What the general government allocates for the regional offices can also be supported by the regional government in some of the regions, so it can be higher in some of the regions. That means that the general budget for organ transplantation can be $100 million per year and the general cost of organ donation can be about $13 million a year in U.S. dollars.

The Chair: Dr. Pfaff, that means they're a little bit more expensive than Canadian dollars. If we do some quick math here on the basis of today's currency, I think it's about $150 million, give or take a few.

Madame Picard.

[Translation]

Mrs. Pauline Picard (Drummond, BQ): Good morning. Thank you for coming. We have heard a lot about Spanish and US expertise. I would like to ask Dr. Miranda to explain more clearly what is accomplished at the national, regional and local levels. What are the responsibilities at each level?

You said repeatedly that you don't need a national registry, even though it is important that there be a responsible person in each hospital to identify donors. How is this accomplished? Do these people get training to be able to identify potential donors? How are families approached?

• 0950

Dr. Blanca Miranda: Responsibilities are shared at all levels and many people are responsible for certain things in the organ donation and transplant process. Responsibilities are more administrative in nature at the national and regional levels while they are more technical at the local level.

Hospital coordinators have technical responsibilities at all steps of the process. They are responsible for the identification and evaluation of the donor and for the certification of brain death. They don't have to do everything, but they must make sure that the process is appropriate and meets both the legal requirements and the terms of the written protocol. They are also responsible for the outcome. They have to make a complete evaluation of all deceased persons in the intensive care units and produce a written report indicating among other things the number of brain deaths, the evolution of these brain deaths and the number of potential donors that were lost due to a medical condition, a cardiac arrest before harvesting or refusal of the family. All this information is sent to the central organization. We get a report like this one which gives an overview of the situation in all hospitals regarding organ donations from the people who die in intensive care units. This is a specific responsibility of the hospital coordinator.

We did our best to provide adequate training to these coordinators. This is not the kind of training you get in medical school. We have to teach every aspect of the job. Our training program is national in scope and is therefore the same for all coordinators. Before they can start to work, they have to go through different levels, including two core courses of a general nature that teach them the whole process of organ donation and transplant. We also provide more advanced courses on specific subjects, as well as courses on family relations, financial matters, media contacts and public dissemination of information, in general. Between 12 and 15 courses are delivered every year with financial backing from our national organization.

Ms. Pauline Picard: Does the coordinator have other responsibilities? Does he get a salary for this work?

Dr. Blanca Miranda: Coordinators are part of a hospital team. In very small hospitals, where the number of donors is no more than two, three or four in a year, one doctor may be the only coordinator. In large hospitals, with 15, 20, 40 or 50 donors every year, the responsibility is shared by a team of doctors and nurses. Members of the team have a regular job as intensivists, nephrologists or surgeons but they also deal with organ donation. They get extra compensation from a special budget provided to hospitals. The amount of US $8,500 covers the whole process, including evaluation of the donor, all required evidence, the operating room and compensation for all participants to the organ donation and transplant process.

• 0955

It's not only the coordinator. There are many other people involved in this process. These people may include a person who only comes to the hospital to harvest the organ, as well as intensivists and nurses who only come to maintain a brain-dead patient. All these people get compensation, which may vary from hospital to hospital since every hospital administrator can allocate his budget as he sees fit, independently from other hospitals.

The Chair: Thank you, Madam.

[English]

The bells will go on for I guess another five minutes, until the House resumes, and then they'll resume again at about 10.05. Those lights will flash until the vote is taken, so please be aware that's what happens.

Just before I go to Madam Caplan, Dr. Miranda, one of the things that came up in a previous intervention is the number of doctors per 100,000 of population in Spain. That number in Spain is quite elevated. I think it's just slightly in excess of 400 per 100,000 population. Is that a factor as well that we haven't taken into consideration, especially relative to countries like our own, which has only about 200 per same unit of population?

Dr. Blanca Miranda: Yes, of course I think this should be taken into account. We have a lot of doctors who need to work. I said that we only have one public health system—the private practice in Spain is not so important. The only possibility for many people is to work in the national health system, and the only possibility of having an extra salary is to work in those kinds of coordinating systems—coordinator of quality, coordinator of emergencies, coordinator of other programs in the hospital. One of these coordinators is the transplant coordinator, of course.

The Chair: Madam Caplan.

Ms. Elinor Caplan (Thornhill, Lib.): Thank you.

I was very interested in the presentations that have been made this morning. I received a lot of information, particularly about the Spanish model. The question I have for you is about the fact that you began with a survey of the hospitals. In Canada, the federal government doesn't have a relationship directly with the hospitals. I'm wondering whether you found cooperation in responding to the survey, whether it was a law that they had to respond. How did you find the cooperation in regard to gathering the data you needed to develop the policy?

Dr. Blanca Miranda: In Spain, the national government does not have relations with the hospitals. We have regional governments, and they're very powerful regional governments in some instances, with a high degree of independence or autonomy. Then we have an interregional council where all the ministries of health are represented. In this interregional council, we have different groups of work. One of these groups of work is transplantation. In this transplantation group of work, every region is represented by means of the regional coordinator, and I'm only one of these groups. We are 18 people—17 regions and myself.

So these regions are responsible for taking decisions like this one, to do surveys on all the ICUs and so on, and to report all the data. But we all agree on that, because we think it's useful and good for everybody. Otherwise, we wouldn't be able to do that as a national health department.

Ms. Elinor Caplan: Each of the regional coordinators is responsible for ensuring the participation of all of the hospitals in their region to respond to the requirements for data information and so forth.

Dr. Blanca Miranda: Yes.

Ms. Elinor Caplan: The next question has to do with the partnership between your national organization and your 17 independent...we call them provinces. Is this a shared-jurisdiction partnership relationship between your national government and your 17 independent regions, or is it a partnership? How did you put it together so people work together cooperatively?

Dr. Blanca Miranda: Do you mean is it written in an official paper?

Ms. Elinor Caplan: Yes.

• 1000

Dr. Blanca Miranda: No, not yet. We are now in the process of rewriting the development of the law of transplantation. We are in the process of passing a new text to include organizations at the national, regional, and hospital levels and how to allocate the responsibilities in each one. Up to this moment, it wasn't in any official paper.

Ms. Elinor Caplan: The next question I have is that we've heard the debate about whether the donation and transplantation systems should be integrated or separate. Ms. Beasley said separate. Dr. Pfaff said integrated. What's the Spanish experience?

Dr. Blanca Miranda: I think we have to be cooperative. There has to be a partnership, but not exactly integrated, because they are different responsibilities and different items. Of course we need to have a close relationship. We are always meeting with the transplant teams. Transplant teams have the right to not impose the criteria for organ allocation, but to speak at the organ allocation meeting. They are represented there, and so on. There is a close relationship between the organization for organ procurement and the transplantation teams and societies.

Ms. Elinor Caplan: Is it fair to say that the keys to your success are the following? One is the cooperation among all jurisdictions. Two is the recognition that in order to make a difference, it's the critical care units, the cooperation in the hospitals, and the way people are asked, as opposed to the development of expensive registries of donors. Three is the accountability component, including education and the monitoring of outcomes. Would you say those are the three keys to your success?

Dr. Blanca Miranda: Also the investment of money in that. This would be the fourth.

Ms. Elinor Caplan: And the fourth, as far as the investment is concerned, is that shared investment, or does that come solely from the national government?

Dr. Blanca Miranda: Everything comes from the national government but can be allocated regionally. It's quite different from one region or province to another, so it depends on the degree of independence.

The budget allocation depends on the regional health departments. We all agree on a general budget for organ donation for our hospitals. The differences between the different hospitals is very small, so we can agree on $8,500 U.S. per donor per hospital. The problem is that with this money they can do as they want. They can pay the people as they want. They can allocate this budget as they want. The only thing is that they need to have a group of people responsible and accountable for organ donation. They have to show us the results.

Ms. Elinor Caplan: Thank you.

The Chair: Before I go to Ms. Wasylycia-Leis, is the reason the national government pays for everything related to the fact that the independent or autonomous regions don't have taxing authorities?

Dr. Blanca Miranda: I'm not an expert in tax authorities. I find some differences between here and Spain. For instance, here you pay provincial taxes when you buy something. We do not have this kind of difference, but we have differences in the taxes we pay as workers. This can be managed locally in some regions. The income taxes from the workers is what is managed locally. The general taxes from the goods.... Also, in some regions they have the right to manage the taxes between companies, and so on.

It's quite difficult for me to explain. For the health department, there is a general budget for health that is allocated and managed regionally by the regional health system. There are agreements between the regional health systems, but there are also differences. For instance, a doctor can be paid differently in different regions doing the same thing.

The Chair: Ms. Wasylycia-Leis.

Ms. Judy Wasylycia-Leis (Winnipeg North Centre, NDP): Thank you, Mr. Chair. I would also like to thank all of our visitors for their presentations this morning.

• 1005

I'd like to focus in on a couple of things that Dr. Pfaff has mentioned pertaining to, first, the whole area of financial barriers in terms of access to donations, and secondly, the cost pressures on our health care systems.

You've alluded to the fact that there are significant differences between the American system and the Canadian system. I guess the most obvious difference is with respect to our publicly funded, universally accessible health care system, which presumably should mean, in our case, access to donations strictly on the basis of need. One of the questions we're struggling with is how do you put in place a meaningful nationwide system for fair allocation, given the huge demand and given the approach we bring to health care?

The second issue, where we are obviously similar, has to do with the cost pressures on our health care systems, regardless of how we fund health care. As more and more happens with respect to inroads in terms of transplantation and a new science brings new solutions, there are enormous costs for our system. We're struggling with that, especially in Canada, trying to maintain our universal health care system.

Can you give empirical evidence to point to the cost savings of a widespread significant organ donor transplantation system, to help us build a case for a huge investment when there are so many pressures all at once on our health care system at the outset?

Dr. William Pfaff: It's most easy for renal transplantation, because that's best studied, and the person to look for is a man by the name of Paul Eggers. He is the research staff of the Health Care Finance Administration. He doesn't publish very much, but he presents a fair amount, and his data is irrefutable. I guess he doesn't want to bother writing very often.

The crossover in the United States at this point for patients who are on dialysis is that you recoup the costs of transplantation in about two and a half years. It used to be four years, but with the development of epogen to maintain freedom from anemia, the costs of dialysis rose. So when you add in the additional costs of maintenance on dialysis, the crossover is about two and a half years after transplantation, and thereafter you save money when contrasted with dialysis.

I don't know how widespread dialysis is in Canada. It varies in all the countries of the world. But in the United States, access to dialysis is very liberal.

The other piece of it, as I looked over some of your Canadian publications, is that a greater percentage of your patients who were managed for end-stage renal disease are transplant patients than is true in our country. My recollection is it's about 35% or 40%. It's 28% in the United States.

That means, of course, that you have many years of successful life after transplantation, in many instances, and dialysis is a pretty severe chronic illness and treatment option. So for dialysis versus transplantation, you can ultimately save money increasing transplant programs. My recollection is that you currently have about a three-and-a-half-year stock of patients awaiting kidney transplantation.

I'm less familiar with the question of cost savings in heart and liver transplantation. There have been some writings that would say that a patient who is managed for end-stage liver disease without transplantation is a very costly patient. So you can continue to pour money into intensive care unit management and get the patient out of the hospital, but soon he or she will be back in the hospital. So there are recurrent hospitalizations, oftentimes with ICU care, which is horrendous in terms of dollars. As to the ultimate balance, I really have no idea.

Heart disease is a difficult problem to answer. It is estimated or has been stated that about 30,000 patients per year could benefit from heart transplantation in the United States. About 2,600 heart transplants are performed per year, so we're only dealing with a very small fraction of the populace.

On the increasing costs, going backwards a little bit, I don't know if the forces are the same here. In the United States, it's mostly managed care organizations, a significant proportion of which are for profit. They had remarkable success in the stock market for several years, and less this past year. It is my hope that they will fail, but who knows.

• 1010

We are a hodgepodge, and I think you all know that. In some ways, many of us look very favourably and hopefully at what you have done in terms of universal care. Yet at the same time, we look with fear, because we know your central government has been under some acute budgetary problems. Actually, in the news last night it was a question of whether you were going to raise taxes or raise the deficit. We are always concerned about our central government structure and what it might do to us instead of what it might do for us, but you carry that responsibility.

Our allocation problems are in part the enthusiasm for solving serious illness with transplantation, and to a greater extent than may occur in other countries. So in the document I've submitted to you, on transplant rates in Canada and the United States, for kidneys, you're doing 31 transplants per million, and we're doing 45 transplants per million; for liver, you're doing 11.5 transplants per million, and we're doing 14.72 transplants per million. That's not so incomparable, particularly when you have a very short waiting list for heart transplantation: 5.4 versus 8.7 transplants per million general population.

I can't lay my hands on your organ donation rate, but I think it's 14.2 donors per million, and we're in the range of 20 or 21 donors per million. But the surprising part of it is what you can make of it. So we do range from 15 to 40 donors per million, and I don't think that is a natural difference. I think that's the kind of investment you've heard talked about somewhat today.

The Chair: Dr. Pfaff, just to put your mind at ease, in the last budget the central government, the federal government, actually put a lot of money into health care. Madam Wasylycia-Leis was the most contented person in the nation when she saw those billions of dollars flowing, and the next happiest person in the country was Dr. Keith Martin, who realized that we were able to increase the surplus in the nation's finances. So we've achieved what you might call a happy balance. The only unhappy person was Madam Picard, because she says this means the system works.

You have an absolutely non-partisan chair, but I'll give members an opportunity to rebut.

Dr. William Pfaff: If your website is correct, there was minuscule increase in the actual percentage of gross domestic product that's involved in health care. Is that true?

The Chair: Are “minuscule” and “increase” two words that can go in the same phrase? “Increase” is the operative one, I think, right?

Madam Ur.

Mrs. Rose-Marie Ur (Lambton—Kent—Middlesex, Lib.): Let's get back to the real subject here.

I appreciate everyone's presentation this morning and really looked forward to Dr. Miranda coming and presenting. We've heard so much about the Spanish model that we've certainly awaited your presence with great anticipation.

I thought you made an interesting remark this morning that our problems probably exist more within hospitals than they do the population. That may be very true, but it was never brought forth in such a succinct manner, that here we're looking at the families perhaps not consenting to a donor's request, and that's not where we should be putting our energies; we should be looking at the hospitals.

Also, I think it's important to have these procurement teams, but hospital budgets are so taxed. I wonder if it would also be beneficial to have a layperson trained in that field, perhaps not with the dollars that you would need with a medical person, to be one of the facilitators working with the families.

Could you comment on those two thoughts?

Dr. Blanca Miranda: Yes. I strongly believe the population is not guilty of anything or nearly anything, so we are guilty of our results, or we are responsible for our results.

I think the way in which the families are approached is quite important. In the situation of an acute grief, there is an important emotional block, and it's impossible to understand what the doctor or the nurse is telling you. It's impossible to assimilate the information in this situation. So it's important to train people with the appropriate skills to get through this block and gain this family for you.

• 1015

In 50% of cases, family denials or negative answers are related to the acute situation and not to them being against organ donation. They were not well informed about brain death, extraction, or retrieval. The treatment or relationship was not good before coming to the hospital with the emergency equipment outside the hospital, in the emergency room or even in the ICU. These things support the possibility of having a negative answer.

So we really need to be trained to approach the grieving families and respect all the things that can be in place in their situations, and so on.

In respect to the lay person, organ donation is definitely a medical activity, like any other medical activity in the hospital, such as heart surgery or microbiology. That's why we strongly believe it should be carried out by medical and nursing teams.

Mrs. Rose-Marie Ur: Maybe I'm playing the devil's advocate here a little. I was a nurse in my previous life. Do you see that being a health care professional and working in the ICU and with the parents or families who are going through undue stress, you may be seen as—maybe vulture is the wrong word—working on both sides of the issue, being there for health reasons as well as for procuring an organ? How do you distance yourself between the two, so the two come together and you're working for the right reason?

Dr. Blanca Miranda: You are asking if there is any conflict of interest.

Mrs. Rose-Marie Ur: Yes.

Dr. Blanca Miranda: There's nothing more sad than losing a patient. It's very sad for the intensive care people to lose their patient, but once they have been lost, there is something good if the outcome is the organ donation. It's hard for them to understand that. It takes maybe years, but it's possible for them to understand that. They distinguish very well when they have lost a patient and the diagnosis of brain death has been made.

The society of intensive care medicine in Spain, in their protocols, have something written about the diagnosis of brain death and the brain death situation, and how they are morally obliged to switch off the ventilator when brain death appears. So the good thing is we can have an organ donor; the bad thing is we have lost a patient. This would not change. The patient has been lost. So if there can be a good outcome, it's good for everybody—the family, the doctors, and everybody. I do not see any conflict of interest.

Mrs. Rose-Marie Ur: Thank you.

You know what we have here in Canada and you know what you have in your model. What would you tell us, as a committee, we should be pushing for? What would be the best thing for us to do here? You're the expert.

Dr. Blanca Miranda: I'm really not the expert. I do not feel I'm enough of an expert to say anything about what you should do. I can explain what we have done. I do not believe the system is exportable, like oranges or fruits. We can simply exchange experiences and ideas, but I'm not really ready to tell you what you should do because I know almost nothing about the Canadian system, Canadian hospitals, Canadian medical staff, etc. I'm sorry.

The Chair: That was very diplomatically put. Maybe later on in an informal session, Madam Ur can press you a little harder.

Dr. Martin.

Mr. Keith Martin (Esquimalt—Juan de Fuca, Ref.): Thank you very much, Mr. Chairman. Thanks very much to everybody for coming today, some from very far away.

• 1020

Dr. Miranda, would be it fair to say the singular most important thing you used in Spain to increase your organ donor rates was the organ donor coordinator program?

Second, I had a little difficulty trying to determine what the costs were for the program. Perhaps you could tell me what the costs were for the program you've introduced, less the actual transplantation costs.

Dr. Pfaff, we had some very good testimony from the Philadelphia experience. They're very successful, as you well know. How different is the Philadelphia experience from the Spanish experience? There was some testimony to suggest the Spanish model may be very good for Spain, but may not be applicable to Canada because the way our positions are viewed and the way our medical system is organized is fairly different from Spain, while the one in America, although different from Canada, has greater similarities. Perhaps you could tell us what the differences are between Spanish model and the Philadelphia model, and what we could use.

Dr. Miranda, please jump in after that to give your opinion. Thank you.

Dr. William Pfaff: For those of you who may or may not know, Pennsylvania passed a state law that all deaths would be reported directly to the organ procurement organizations. There are two organ procurement organizations in the State of Pennsylvania: the Delaware Valley Transplant Program serves Philadelphia and its surroundings, and the University of Pittsburg...actually the western Pennsylvania OPO is centred in Pittsburgh. Both were subject to the potential improvement of identifying all donors. Both were better than average organ procurement organizations, in terms of donors per million.

With the passage of the law, but also investing in a greater number of individuals to serve the organization, the Philadelphia OPO increased the number of transplanted organs by 40% between 1994 and 1997. They are still short several OPOs in the country.

There is no thought or reason to the distribution of high performance in our country. The most successful areas are the State of Florida, the State of Wisconsin, eastern Pennsylvania—that is Philadelphia—and surprisingly, Nevada. The best I can tell, there is nothing in common in any of those geographic regions. All tend to have a greater number of coordinators for their population. They form the greatest base for expense in conducting organ procurement organizations. A certain amount of our costs relates obviously to direct donor costs, such as the operating room, the intensive care unit, laboratory services and so forth.

There is also some relationship in performance that I can see, to public education. On the question Madam Ur asked a minute ago about public education versus hospital education and the contrast in countries, both types of education are successful and both are necessary for success.

My conclusion, from all of our debates about organ donation and transplantation, is it's remarkably multifactorial. It is important really at every level of government, but it's actually implemented locally. The makeup of your organ procurement organizations is not known to me, but I think they emanate from the transplant programs. Is that true?

A voice: By and large.

Dr. William Pfaff: We have every variety of that. So the State of Michigan is an OPO. All of New England save for the Hartford area is a single organ procurement organization. The most successful organ procurement organizations tend to be in the range of about three million population served.

I think everything you've ever read or heard or will ever read or hear about organ donation is true, though the answers are different. You have to do all of those things and everything you've heard from this group today to reach the greatest success.

Mr. Keith Martin: Dr. Miranda.

• 1025

Dr. Blanca Miranda: I strongly believe the difference between Spain and other countries is this in-hospital team responsible and accountable for organ donations, definitely. Also, of course, there is the transmission of the message to the population, the information about the organ donation system, that it is a credible system useful for everybody, etc. But it's mainly the work that has been done within the hospitals.

The budget, I repeat, uses nearly $3 million for the organization system—national, regional, and training programs—and $11 million U.S. per year for the in-hospital performances, including the extra salaries of the coordinators and all things related to organ donation: the one-day ICU bed, the operating room, the people who come from their home only for organ donation.

In speaking about the differences between America and Spain, I said I'm not familiar with the American or Canadian systems, so I know few things about the in-hospital practices here or in the United States. But I'm sure there are differences. Some of them have been stated this morning—for example, the number of doctors, the objectives of the doctors, or the in-hospital practices within the ICUs, etc. Certainly this must be analysed before trying to put in place any idea or initiative.

The Chair: Be very brief.

Mr. Keith Martin: Dr. Pfaff, your point is well taken that we have to do all of the above. The problem, of course, is that we're all restricted by our limited resources. We have to somehow prioritize what the most important things are that we can do. If you have any views on that at some time in the future, please let us know. It's like the old 80-20 solution: we can spend 20% of our money getting 80% of the solution, and 80% of our money getting the last 20%. Unfortunately, in spite of the government's $11 billion infusion of money, we still have to focus on that 20% of our resources, because as you correctly said, it was just a little bit of an increase.

Dr. William Pfaff: The most important investment is in the coordinators and other individuals in the procurement organization. As an example, there are two steps in the organ donation request. One is the initial approach and the other is the formal request. When those are done by the same individual, a trained individual, experienced, free of the emotion of caring for the dying patient, our success rate is 78%. This is in our own institution.

We studied it over the course of.... I've recently looked at the last eight years of data. If the initial announcement of the possibility of organ donation is made by a trained individual from the organ procurement organization and then the direct request for donation, which is done at a different time—the coupling that I think Carol talked about earlier—is made, our batting average is 78%.

It drops progressively when either of those roles, and particularly the initial approach to the patient, is made by somebody else. If a physician, nurse, or surprisingly even the hospital chaplain takes that role, the guilt or hurt that he or she shares with the family at the time is actually an impediment. So I think the greatest investment—and this bears out with what Dr. Miranda said—is the personnel involved.

Mr. Keith Martin: Thank you very much.

The Chair: Ms. Beasley, did you want to comment on that last statement as well?

Ms. Carol Beasley: Yes.

I think what we're finding—and this speaks to an earlier question about whether a lay person might fulfil a role in actively counselling the family about donation—is that having prior training turns out to be extremely important. In the U.S. system, some of the work we did showed that when there was collaboration between someone on the health care team and someone who was trained in donation-requesting techniques—in this case it was someone from the organ procurement organization—consent rates were significantly higher than when other combinations of not so formally prepared staff were involved.

• 1030

Our observation of working in Canada is that roles differ from place to place. One of the observations I have made here, at least in the critical care departments I have become familiar with, is that the role of the critical care physician is higher profile here than it is in the States, and that the ICU model is much more weighted toward the closed ICU model, with a full-time intensivist on staff, who really has ongoing and very close contact and communication with the family. And that is a responsibility the critical care physicians take very seriously and would be very unwilling to abridge or limit.

I think the good news is that they are committed to family communication. The bad news is that many are not particularly well trained around donation issues.

What we have done to address that in the Edmonton project I mentioned earlier is to have family support coordinators, who are typically nurses.... The team is actually in the process of formation. We expect it will be predominantly nurses, but perhaps also pastoral care professionals and social workers, to provide the safety net around that family communication so that when the physician is busy, if the family still has lingering questions about some aspects, say, of the brain-death diagnosis, or some aspect of the care that was provided, there's someone to provide backup to the physician.

So I think that, recognizing differences in structure, in the U.S. there's been a great move to involve the OPO coordinators more actively in the requesting process, and that seems to be appropriate for the U.S. setting.

It's not quite as clear that this is the exact correct solution here. It may be that because, in part, of the high level of responsibility and high profile the intensive care physicians have, it seems to make a lot of sense in the Canadian context to have family support services based within the critical care domain. That's exactly the solution we've come up with in Edmonton.

I think the bottom line is that this is not a role for someone who is unprepared for it. This is a role that is very subtle, very sensitive, very emotional. It's not something that people should be thrust into in a state of unreadiness or a state of apprehension. It really needs to be recognized as a very, very special and intimate kind of communication that requires people to be well prepared and well trained.

The Chair: Thank you, Ms. Beasley.

We have about two minutes before we have to appear in the House. I don't want to rush you, Ms. Wight. I know you wanted to comment on this as well. When we come back, I'll have four other people who want to ask questions. So if you want you can make a comment of about a minute or two, Ms. Wight, and then I'm going to have to suspend.

Ms. Celia Wight: Thank you very much for the opportunity. It will be a brief comment, because I agree with what everybody else has said about the necessity for training.

To be flexible, you can't prescribe for any one country or any one intensive care unit what the best way is, or you can't prescribe a set way. But it's to identify the individuals who will deal with the family, and ensure that they will be adequately and properly trained, are prepared to take on this responsibility, and are allowed to take on the responsibility. So I really agree with everybody.

Thank you.

The Chair: I thank you all very much. Again, I apologize for the inconvenience, but I must suspend. It will probably be about 25 minutes. Everything depends on what happens next door. I leave you in the capable hands of our clerk and our researcher.

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• 1107

The Chair: We're going to resume the session. Thank you for your patience. We may be disrupted again, but such is what happens in parliamentary sessions.

We finished off with Madam Wight. I have several people who want to say something. Do you want a full five minutes? If you do, you'll have to wait.

Ms. Elinor Caplan: No. I have just a couple of quick questions, if I could.

The Chair: Go ahead.

Ms. Elinor Caplan: In my discussion with Dr. Miranda I asked about the relationship between the coordinator and the hospital and the coordinator and the program. I wonder if she could explain for us, please, as she did privately to me, who hires the coordinator, who pays them, what the accountability is, and how you make sure that every hospital has a coordinator.

The Chair: Dr. Miranda.

Dr. Blanca Miranda: If you want to be an authorized hospital for organ procurement or organ transplantation, one of the requirements is to have a transplant coordinating team. So you do need to have a transplant coordinating team in order to be officially authorized as an organ procurement hospital or an organ transplantation hospital. The director of the hospital decides who will be on the transplant coordinating team. I do not have the right to decide anything in this field.

Also, I cannot decide who will be the regional coordinator. It is the regional government that decides who will be the regional coordinator. I can send to the regional government or the hospital a report explaining what the performance is or explaining my point of view, but I do not have the right to decide who that will be.

• 1110

The director decides who among the staff of the hospital will be the coordinator. They always are a staff member of the hospital. They do not contract somebody from elsewhere to be a transplant coordinator. They pay the extra salary from this budget that is allocated for organ donation of $8,500 per donor.

The Chair: Thank you very much.

Next is Ms. Maria Minna.

Ms. Maria Minna (Beaches—East York, Lib.): I wanted to ask Dr. Miranda about an earlier discussion with another colleague with regard to presumed consent and a national registry. One of the things we've heard over the last few weeks is a fairly constant recommendation that we have a national registry. Some of the provinces have in fact established a regional one, such as in B.C.

The other part of the national registry is presumed consent. We have had different submissions on this. Some people have said that if a person signs something, such as the back of their driver's licence, or they've indicated their wishes elsewhere, that should override any family preference. Others have indicated that regardless of the wishes of the deceased, the family is important and if it is approached, then the family's final wishes are listened to.

In Spain, do you have any system where people can at least indicate that they wish to leave their organs, so that the family at least knows what the wishes of the deceased are from the start?

Dr. Blanca Miranda: People can carry a donor card. We have donor cards. But this is not an official document, so the decision lies with the family. From our surveys we know that most of the Spanish population want this decision to be left with the family, just to be sure that everything is okay. I want to know that my family knows or is sure that everything has been done okay and everything is in place. So most of the Spanish population think that any kind of predecision or a strictly applied predecision system would be in some instances an abuse of authority or even an insult to the family. Up to this moment they want us to ask the family at the latest moment.

We carried out one survey in 1991, another in 1995, and another is being carried out now, just to monitor what is the Spanish population willingness. If the time comes when they want the system changed, then we will change the system, but not before the Spanish population changes their minds, because to impose any other solution could have, as far as I understand, a negative outcome for organ donation.

Ms. Maria Minna: What kind of donor card do you have? Is it on the back of a driver's licence, or is it something separate that people have to fill out?

Dr. Blanca Miranda: It's separate. There's a different card for organ donation. You can have hundreds of models of donor cards. We have one, but the patient associations have another one. Some regions have their own donor card. It's only a public sign that we want to become a donor, but this is not an official card.

Ms. Maria Minna: So you don't have a national approach to a registry in that sense.

Dr. Blanca Miranda: No, not yet.

Ms. Maria Minna: Thank you.

The Chair: Is there one in the U.K., Ms. Wight?

Ms. Celia Wight: In the U.K. we use a donor card system. By signing the donor card, an individual will be saying, I will be a donor in the event of my death. But in all cases the family is also approached. So whether or not they have a card, the family has the final word. The family can even override the wishes of an individual carrying a donor card.

Four years ago in the U.K. the government did introduce a donor registry for people to register if they would like to become a donor in the event of their death, and I have to say that it has had a very poor uptake. We have a large population, and I think there have been only about six million positive registrations in four years. It has cost an awful lot of money. So the approach is carry a donor card, but the slogan that goes with the donor card these days is please discuss this with your family. So that's an add-on to saying I want to be a donor; it's please let your family know of your wishes so at least they know in the event of your death what you would have liked.

• 1115

The Chair: If you say that the family has the override, is it because English law doesn't recognize that declaration of intent is legally binding?

Ms. Celia Wight: Actually, in English law, in the Human Tissues Act, within the law one is able to remove certain parts of the body for the benefit of others. So within the law you could do it if the patient carried a donor card. However, I believe it's the fact that for the few families who override the wishes of the deceased, perhaps the bad reaction, or the negative impact on organ donation and transplantation, in ignoring the family would be counterproductive. If a family feels so strongly that even in the face of their relative's desire to be a donor they won't allow it, one should allow their wishes to stand. It's not legal to do so, but it's being done out of compassion, and perhaps the risk of a negative reaction if this became public knowledge.

The Chair: I saw Dr. Pfaff wincing a little bit.

Dr. William Pfaff: No, I was thinking. It's painful for me.

The U.S. Uniform Anatomic Gift Act, which is passed individually in each of the states, provides the donor card as a legal document declaring the will and mandating it. It's offset in exactly the same fashion that was just described in England. And in some states, in some OPOs they've said they would proceed regardless of the wishes of the family; in others, for the identical reasons that you've just heard, we think this may not be the best thing to do in those rare instances.

It's really very uncommon, if a family is told or knows that their relative, who is now a potential donor, had expressed the wish, to overrule that wish. It does happen, and I was thinking about it as we were talking earlier, in the initiation of a discussion of organ donation. In our own OPO, about 15% or 18% of the time the initiation is actually made by the family, and the family says to the physician or nurse they would like to discuss organ donation. Yet for only 85% of those individuals is consent granted, because another member of the family is in opposition. So a variety of scenarios can ensue.

I also was thinking about the issue of the registry as I've heard others talk. We've had a registry in the State of Florida for about 14 years. It doesn't work, or at least it doesn't work yet. It's supposed to work this year, and I hope it does. It's matter of cost. If you have a registry under our system of law, you have to have a mechanism for withdrawing your permission to be a donor. So there is a fair amount of thought in designing such a registry and the hardware and software that goes with it, the communication capability that's needed.

I've always regarded it as a means of education, rather than a means of technical availability. For years there were millions of cards sitting in an office in Tallahassee but without 24-hour immediate access, which is what is necessary to make proper use of a registry. There has to be 24-hour access; it has to immediate, so that when a potential donor is identified one could call, wherever the registry is, and ask if Mr. Smith is a registered donor.

The Chair: Thank you.

[Translation]

Madame Picard.

Ms. Pauline Picard: Dr. Pfaff, your organization, UNOS, is national in scope. Is it active in all US States? Are all States subject to federal authority in health care matters?

• 1120

[English]

Dr. William Pfaff: It's an interesting question to raise this year. We're in the midst of revolution.

Let me explain for just a moment. UNOS is a not-for-profit corporation that has national representation. Its membership is made up of all transplant programs, all independent organ procurement organizations, and that's about 85% of all of our OPOs—the remaining ten or so are hospital-based—all independent laboratories, and then a substantial number of public members, both organizations and individuals. It has an elected board, and that board represents, indeed, the transplant community country-wide. There is only perceived authority of our organization. It was created by Congress, but with the provision that neither Congress nor the administration would be responsible for policies, such as allocation, such as membership, but only the secretary would have oversight. The exact definition of that remains a bit cloudy because of regulations that the secretary dictated last year and then were put in abeyance by Congress.

The structure is dependent upon, and always has been.... No secretary, since its inception in the mid-1980s, has ever signed off on any of the policies. So our compliance to our policies has always been voluntary, and really the consequence largely of peer pressure.

Do any of our members ever vary from our policy? I believe so, and that's why we have fights. If somebody has varied substantially from the policy, he basically is placed in a public pillory. So that's how we punish people, with peer pressure. Actually, that has a lot of P's in it. I like the sound.

The Chair: Yes, the alliteration's good. It's just like Pfaff.

Dr. William Pfaff: No, it's like Pfister's faucets.

But there is national sway. Everybody has to follow our public policy or be subject to discipline, but the discipline is not, at this point, other than generated by peers. The secretary has the potential to withdraw medicare from the whole institution, and that has never been done.

The Chair: Madam Redman.

Mrs. Karen Redman (Kitchener Centre, Lib.): Thank you, Mr. Chairman, and I apologize for missing an earlier segment. So if this issue has been covered, I'll give that caveat at the beginning.

One of the things we're heard from witnesses over time is that one of the barriers to organ retrieval in this country is actually the financial disincentive that hospitals suffer procuring the organs. I'm wondering if there are financial disincentives in Spain. And if there are, how are they overcome, and has it had an impact on the organ donation? Also, are there any financial incentives in place?

Dr. Blanca Miranda: I do not know if there are financial incentives. What we have done is not to have financial disincentives for the hospital. I think we cover the costs of the hospitals with this money we allocate to the budget of the hospital for organ donation.

What we thought at the beginning is that it's not possible to have beautiful transplant units that cost a lot, that are technically well prepared and with large waiting lists, and to not allocate any amount of money in the organ procurement side. You need an organ procurement side behind this beautiful transplant unit. That's why we decided at the beginning of the nineties to allocate money to the organ procurement performances within the hospital. This costs a lot for the hospital. It's a 24-hour ICU bed, the maintenance of the donor, all the drugs you have to use, all the extra determinations you have to perform on the donor for the evaluation of the donor. The retrieval is also of a high cost. You need somebody responsible for all of that, and you have to pay for it. That's what we did.

I do not know if this is an incentive for working in that. I assure you that I have been a transplant coordinator in a hospital, and I didn't do it for the salary, because when you leave home, it's for 20, 24 hours. This is not paid with any money, I think.

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Mrs. Karen Redman: Thank you. I guess I was looking at it from sort of an institutional disadvantage, a financial disadvantage to institutions that are taking their base budget with no allocation specifically for this.

I don't know if any of the other witnesses would like to comment on the model they're familiar with, if there are disincentives or incentives.

Ms. Celia Wight: It's a very interesting question.

In the United Kingdom a cost analysis was done on actually producing a donor for intensive care units, which was too expensive for the Department of Health to access. So a reduced amount of money, which is actually 1,000 pounds per donor, is available to hospitals or intensive care units following the provision of this donor, assuming they've gone through the normal and accepted routing to report the donor and the organ allocation is correct.

Surprisingly, a large number of hospitals do not reclaim that money. They're not given it in advance; they have to claim it and prove that the allocation has been according to the national system. Some hospitals do claim the money, and the hospital administration takes it for their own purposes, whereas it was actually intended to go back to the intensive care unit. So the money is available, but people are being very careful or quite clever in not necessarily letting people know it's available.

But it's interesting that occasionally hospitals that are aware of that small amount of money choose not to claim it. In a way, that supports what Dr. Miranda has just said. On the other hand, we do not have a proper financial situation for donation in the United Kingdom, so nobody is responsible for saying how they spend the money. You provide an appropriate amount of money to hospitals for organ donation, but they have to justify the use of the money. There's a different way.

Ms. Carol Beasley: In the United States, I'd say it's a bit of a hybrid system. There is coverage for the costs that are incurred in caring for a donor in performing the recovery surgery after the family has consented to donation. But there isn't any coverage for events that happened before that, and one of the things we haven't done an in-depth study on but we've been very interested in is this question, what does it take to bring a hospital to a state of readiness for donation?

We do notice in the U.S. that a number of the organ procurement organizations will find creative ways almost to put more resources at the disposal of the hospital, mostly in terms of in-kind services, providing education for which they do not charge. Sometimes some OPOs are actually underwriting the cost of a staff person in the hospital to be similar in function to the donation or transplant coordinator in Spain or the role we have developed here in Edmonton.

So there's coverage to a point, but only after the family has consented and the donation is going to move forward in actuality. There's really very little that makes it possible for a hospital to be ready for donation.

What that implies for a hospital is if donation is something they recognize as part of the constellation of services they offer to families, and particularly to bereaved families, they need to summon some resources from some other important activity to underwrite donor donation readiness within their own institution.

So I think we find frequently in the U.S., similar to the findings here, that very few of the relevant critical care staff have been trained, and there isn't much in the way of ongoing support for those people who are on the front lines and most likely to be active and be involved in the early stages of a potential donor situation.

Dr. William Pfaff: I think the costs are fairly paid, and actually, it's a little more than that. Under the health care finance administration rules, hospital charges are paid. In the United States of America, nobody pays charges any more. There's a great distinction between cost, payments, and charges, so there is a mild advantage.

On the other side of it, as OPOs' total costs have increased, they have approached their hospitals and asked if they will settle for 80%, when everybody is paying 70% or 75%, or in the case of Medicaid, 60%.

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The other feature is that everybody involved in organ donation cannot provide incentives, of course, to a family, and shouldn't to an institution. All the entities are not for profit and have to meet IRS and hit the health care plan administration standards on both those points. And there is auditing. All OPOs are audited annually by one or more bodies.

The Chair: Thank you.

We'll go now to Mr. Vellacott.

Mr. Maurice Vellacott (Wanuskewin, Ref.): I want to propose for the witnesses here today a possible wording on an organ donor consent card that's very basic and to the point, and I'd like to get your response on how you feel about this kind of wording. It revolves around discussions we've had in the matter of brain death. It would simply read, “Are you willing to donate your organs after you are declared brain dead?” Would you be agreeable to that kind of wording? Would you think that would be okay to have on an organ donor consent card?

Dr. Blanca Miranda: Then what about non-heart-beating donors or tissue donors? If you only contemplate brain-dead people, you are speaking about extra-renal organs only—

Mr. Maurice Vellacott: Okay.

Dr. Blanca Miranda: —because kidneys and tissues can be retrieved from people who are not exactly brain dead but declared dead with cardio-respiratory criteria.

Mr. Maurice Vellacott: So in respect to those organs where brain death is required, would it be okay to have a wording to that effect? Qualify it, then, as you suggest, and in respect to those organs, would you think that would be an appropriate or okay wording to have, to say “Are you willing to donate your organs after you are declared brain dead?”

Dr. Blanca Miranda: I think this is in all legal text. Organs or tissues cannot be procured before the people are declared or certified dead. So this is in the legal text.

Am I wrong?

Ms. Celia Wight: Would it be easier to leave it as “death” rather than separate out “brain death”? I can't understand why you would want to bring in....

Mr. Maurice Vellacott: Well, there is a philosophical debate that brain death is not death, which you would be aware of and you may disagree with. But if in fact it's about brain death and we're saying it's synonymous, why don't we simply qualify it, clarify it, use the adjectival? Is there a problem with that?

Ms. Carol Beasley: I don't see the advantage to it. It seems that it does reinforce notions that brain death is not quite death.

We do know that brain death is a very confusing issue for a lot of families. In the study we did, while most of the families that declined to donate used the term “brain death” to refer to their relative, they harboured the belief that someone who was brain dead can recover, when in fact that's not the case. Someone who is properly declared brain dead cannot recover.

So I think it perhaps contributes to more confusion than it alleviates, by suggesting that there's more than one kind of death, that there's this kind or that kind, not that when you're dead you're dead.

Dr. William Pfaff: I agree completely. I have the same reaction. You would then have to explain brain death, say why it's different, when it isn't, because if somebody is brain dead, the moment you shut off the ventilator they're on their way to all kinds of death.

In the United States' law, it was based on Black's Law Dictionary, which was, initially, “the absence of spontaneous respiration or cardiac activity”. That was the definition of death until, gosh, I think it was late 1968 or 1969, when the Harvard consortium got together and defined “brain death”.

Now it's undergone redefinition in some states, but the general public perception may still be that an individual may be in a deep coma, as opposed to brain dead. It's the explanation of that difference that's important in bringing it to fruition in a family, but it requires very specific explanation at the time. That's the process of initiation I spoke of earlier.

Mr. Maurice Vellacott: That's exactly my point, because the fact is, by your own acknowledgement here, you have to get into an explanation of brain death at some point anyhow. I'm not saying that any one of you is suggesting that we skirt that issue, that get around it and shield it from the public. We have to explain it later, so why not provoke that or raise it sooner, rather than later?

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Dr. William Pfaff: Because you're going to have to educate 500 people for a solid purpose in one. The process of education and retention is such that you would probably create more difficulty than you would want. “It is my wish that after death any or all organs I have may be used for transplantation” is really the statement an individual would wish to make, without the specifics.

Mr. Maurice Vellacott: Dr. Belitsky?

The Chair: Dr. Belitsky, Elizabeth Barker, and Prudence Taylor are actually here as observers. I asked them to sit around the table.

Mr. Maurice Vellacott: I wasn't aware of that.

The Chair: That's okay. We were concentrating on putting the other four under the gun, so to speak.

Mr. Maurice Vellacott: Yes. Okay.

My next question to each of you relates to donor action. It makes the point under results that average rates of skills and competence, and so on...highest under certain...and then much lower comfort levels reported on explaining brain death, 44%, introducing organ donation, 38%, and requesting donation, 31%.

Do you believe it is a lack of training of front-line workers, and so on? Would it completely resolve or solve that problem if there were training and you wouldn't have this lower comfort level on explaining brain death, introducing organ donation and asking for donation?

The Chair: Mr. Vellacott, in fairness to everybody else, part of that was already answered. But I will ask one of them to summarize the response they gave to a question like that earlier, if you don't mind.

Do you want to start, Ms. Wight?

Ms. Celia Wight: Yes, I believe it is a question of lack of training, but it's also a question of lack of organization, delegation, or acceptance of responsibility. Those results demonstrated the current ad hoc donation process, as it stands at the moment. It just depends who happens to be on duty at the time, who has to deal with these issues. Because of those results we advocate appropriate training and delegation of responsibility to specifically trained people, and acceptance of that responsibilty within the intensive care unit.

Ms. Carol Beasley: I would strongly concur with what Celia Wight has just said.

It's really the two issues of having people properly delegated to be responsible for the process and having them well trained.

If you think for a moment about organ donation, it is not a frequent event, even in large hospitals. In the work we did in Canada, I think the largest number of potential donors was about 40. This was in a hospital with probably 800 or 900 beds, four or five ICUs including the emergency room, three shifts of nurses every day, plus relief people on weekends and holidays.

So to imagine 40 cases interspersed in that level of activity, and allow the response to that to be purely by chance that a family would be met by someone who had been well trained and well prepared for this, is really not a very acceptable system from anyone's point of view—from the point of view of people who want to do transplants, or from the point of view of families who are in great distress.

I think we're really looking at a combination, as Celia Wight has just said, of response delegation or determination of responsibility and making sure those people are adequately trained to fulfil the role well.

The Chair: Dr. Miranda.

Dr. Blanca Miranda: After implementing donor action, the results on the survey improved significantly. People felt much more secure, after being trained and having the program implemented and in place, being involved in these kinds of procedures.

The Chair: Dr. Pfaff.

Dr. William Pfaff: It demands expertise. I agree with what the others have said. A far more productive outcome is highly predictable if you have the appropriate personnel and retain them.

The Chair: Thank you very much.

Mrs. Ur.

Mrs. Rose-Marie Ur: Thank you, Mr. Chair.

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We've listened to many presenters say that even though you have your organ card signed, your family still has the right to overrule your request to have your organs donated. Everyone says we have to contact the family. How far removed in the family do we go? There's the spouse, the siblings, the parents—where do we have to stop? How many people in the family do we have to approach before we can say whether we have consent? I've never heard that question asked. I wonder if you have some answers to that.

Dr. Blanca Miranda: In my experience, you have to identify the key member of the family to decide. Sometimes it's the wife, sometimes it's the son, sometimes it's the father, sometimes it's somebody else. In Spain we have big families with a lot of members, and this is an art. You have to identify the key member and who to approach appropriately.

I have seen some legal text in which it is written who is legally responsible for giving consent. In the case of the husband, it's the wife. In the case of the wife, it's the husband, and so on. This is the exception. I think most legal texts do not say anything about it. So it's the family, the close relatives.

In the case of the absence of the family, in Spain we have to go to the judge who is on duty that day in the city. They have to sign the consent in the case where we do not find the family. For instance, in the case of foreign people we are obliged to try to find the family through the embassy and so on. Even in that case, if it's not possible the judge has to take the responsibility of signing the consent.

Ms. Celia Wight: On the whole, I agree with Blanca Miranda. Within the U.K. and other countries it may be a little more clearly defined who the next of kin is. But at the end of the day, the family goes back to discuss this among themselves. It's possible that you may have your first discussions about organ donation with perhaps two members of a family, who will then need time to think. They will go back to discuss the matter with other members of the family.

I don't know of any situation I've ever been involved in where the husband agreed to organ donation and the grandmother disagreed and we took no notice of the grandmother. We don't do that. We leave it to the family consensus. I think on the whole that is beneficial to any system. You don't want people going back into the community and saying their wishes were not heard, and something was done to one of their loved ones they did not approve of.

We don't get big conflicts within families that often. It's only if you have a very large family. In Spain, of course, the families are much larger. We do have very large families in our various ethnic groups within the United Kingdom. We don't often find a conflict here.

Ms. Carol Beasley: In the U.S. there's also a legal hierarchy in terms of who is the next of kin, whether it's the spouse, the parent, the child or the sibling, and that's certainly heeded. I think the normal practice and the recommended practice is also to let the family indicate their preferred involvement and style of decision making. You will find differences from individual family to family. You will find differences around multicultural backgrounds. I think that is definitely to be respected.

In doing a study of donor and non-donor families, we found something surprising. We had always assumed that with more people involved in the decision-making the propensity would be to decline donation rather than approve it. We sort of harboured the notion that more complicated family discussion would discourage donation. We did not find that in our study. In fact we found lower rates of donation among individuals who made the decision solo, without consultation with anyone, than we found in cases where there was family discussion.

So we have to respect the stated preferences of how families wish to decide these matters, just as we respect family preferences around any end-of-life decision. That is really for the family to say.

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Normally what happens is that the person who is a legal next of kin is contacted and in the end they have to sign a legal permission, but they then are free to involve other family members as is most appropriate for their family needs.

Dr. William Pfaff: I think there's an alpha in almost any family; it can be an alpha male or an alpha female, and that's how those decisions are made. But indeed, most of the states have a hierarchy of responsibility that is defined as spouse, adult children, parents, and all of the familiarities you might associate with inheritance rules and everything else, whoever is going to be responsible for even other elements of disposition. I think in Florida it's clearly defined, but I'm not sure about all the other states.

The Chair: Thank you, Madam Ur.

We'll turn to Madam Caplan for the last question.

Ms. Elinor Caplan: I had an opportunity to look at the paper on quality assurance in organ donation, and it seems to me that this is the accountability aspect. I'm wondering how much information is made public and how much is made available to all of the participants in the program.

To Dr. Pfaff, was it the highlighting of the problems that you referred to as public pillorying?

Dr. William Pfaff: That was more by organ transplant programs in terms of an allocation process, mislisting a patient or allocating an organ that was out of even their own order, so that there are occasional behaviour problems.

Ms. Elinor Caplan: So the accountability process is a positive one. Is it a model of continuous improvement and the sharing of information to improve the standards, so that it's positive? I see heads nodding.

Dr. William Pfaff: Are you speaking of organ transplantation or organ donation?

Ms. Elinor Caplan: I think both, because what I heard about the Spanish model is that there's a monitoring of donation procedures and rates, and there's also a monitoring of the transplantation programs. Am I correct?

Dr. Blanca Miranda: Yes, you're correct. We inform all the people about their own data, and the rest of the data is presented globally to these people. Each hospital does not know exactly what the performance is of the other hospitals but does know what the performance is in the region in a global way for the three types of hospitals we have, which are defined by their size and the availability of neurosurgery, transplantation units, etc. So we do this kind of analysis, and we present the data globally. Each hospital has their own data by means of the outcome of the transplantation programs and the outcome of the donation programs, but they do not know what exactly the performance is of the other hospitals one by one. That information is only for the authorities.

Ms. Carol Beasley: In the U.S. and Canada, we, as well as other organizations, have been involved in doing medical records reviews in hospitals, and that gives you very detailed information on the number of potential donors that occurred and what happened to them.

I think there are two things. First of all, it has been a purely voluntary activity. Only recently was a regulation passed in the United States that compels hospitals to permit a review of their medical records by their organ procurement organization, so that's a relatively new development. What we did formerly was to ask the hospitals for permission to review, and the agreement on the use of the data was very similar to what Dr. Miranda has just described.

We reflected back to the hospitals their own data, and we shared with them aggregate data from the collection of hospitals, whether it was regional, state-wide, or national. It's a very interesting process to share with hospitals this kind of data, because they're often surprised. If you go in to interview critical care staff about how they perceive the donation process to be going, you'll get a story that goes kind of like this: “We're fine and they're not. All those other hospitals out there are probably not doing a very good job, but we're doing a fine job here.”

What we find is that when we can reflect back a fact-based portrait of their hospital and do it not in the spirit of a report card or a judgment but in the spirit of problem-solving, learning, and figuring out what the opportunities are to do better, on the whole people are very responsive to that. They may have questions, which they're entitled to have. We often go back and review charts again if someone has a question about something. Then they become extremely interested in how everyone else is doing. How do we compare with the whole? Are we better? Are we worse? It does become, I think, a very potent catalyst for improvement. Just the exchange itself of letting people know what's going on in a very transparent way is very catalytic to hospitals. It's usually the anchor point from which they start to actually make significant program improvements.

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While we've done it on a voluntary basis and I think it has to be done in a respectful spirit in terms of the sharing of information, any way to expand that and to use that data to paint a more complete picture of the underlying donor potential pool would be very useful to the system as a whole.

The Chair: I know our witnesses have a really full schedule this afternoon. They're going to be talking with the national coordinating group co-chaired by Dr. Belitsky and Elizabeth Barker and I guess soon by Prudence Taylor.

On behalf of all committee colleagues, both present and those who were here earlier on, I want to thank each and every one of you for a most engaging presentation. At first all the questions seemed to be weighted toward Dr. Miranda for the reason that we had heard a lot about the Spanish model; but as you can see, our colleagues around the table have now developed a wide range of interests in this area. So I thank you on their behalf and for myself as well for taking the time, travelling the distance, and being as frank as you have been. I can only assure you that your presentation is going to be reflected in the committee deliberations.

I now adjourn to the call of the chair.