Advisory Committee on Organ Transplantation

U.S. Department of Health and Human Services
Advisory Committee on Organ Transplantation (ACOT)

Summary Notes from Meeting
Washington, D.C.
May 6–7, 2004

Welcome and Update

Nancy Ascher and Jack Kress

Nancy Ascher started by saying that she looks forward to the important contributions this committee makes to the arena of organ transplantation. The outcome of this meeting will be guidance and direction to the subcommittees to be the basis of recommendations they will generate for the November meeting. She said that she does not anticipate any recommendations being developed at this meeting.

She introduced Jim Burdick, the director of the Division of Transplantation, who was standing in for Michelle Snyder, the Associate Administrator of HRSA. Burdick commented on an important upcoming transition: Jack Kress, the executive director of ACOT, is moving on this summer to a study assignment under the aegis of HRSA at the Albany Medical College in New York State. He pointed out some of the highlights of Kress's tenure with the U.S. Department of Health and Human Services (HHS) as he worked on legal and ethical matters. Most significantly to ACOT, Kress was involved in developing the early structure of ACOT and its processes. He saw to the development of all of its recommendations, which he then shepherded through the department. He has facilitated progress after recommendations have been approved. In every way, he has been a major factor and supporter in our efforts. Burdick presented Kress with a Special Acts Award and certificate to recognize his dedicated service to ACOT.

Burdick went on to introduce the new executive director of ACOT—Thom Balbier—who has worked at HHS since 1977, primarily in the area of scientific and governmental aspects of vaccine programs. Balbier briefly addressed the group, saying that he was looking forward to working in this important field and meeting the committee members.

Kress thanked the participants and the audience. He noted that he has a long history in the Albany area and looks forward to returning to research. He plans to continue to work on organ donation reform and improvements. He plans to start by learning what happens at the ground level. He expressed his thanks to the ACOT members. He noted that there will be a long transition period during which he and Balbier will overlap to ensure that ACOT's efforts will continue seamlessly.

He then introduced the next item on the agenda—tissue and body part concerns—noting that this topic has grown out of two developments: (1) the efforts of former ACOT member Margaret Coolican, who pushed us into the realm of tissue and body parts; and (2) recent events and adverse publicity in that field, which may affect organ donation. We need to ask about what we need to do in this area.

Panel on Tissue and Body Parts Concerns

Moderator: Michael Seely
Panelists: Todd R. Olson, Hon. Margaret W. Henbest, Ronn Wade

Michael Seely thanked the committee for including this topic, which was brought to light by the media. It has had top billing in many large media outlets. The integrity of the national organ transplant system is at stake. We have not spent much time on other forms of donation, but we need to consider these issues. Currently, the federal regulatory framework does not represent a consistent approach. Certain aspects of tissue recovery and handling are subject to inspection by the Centers for Medicare & Medicaid Services (CMS), and other aspects are subject only to a voluntary accreditation process. Whole body donation and use is largely unregulated, although there may be rules and guidelines for oversight within institutions.

Margaret Coolican was motivated to bring this issue to the attention of Kress who in turn directed the issue to the attention of this subcommittee. The fact is that there are many more tissue donors than organ donors every year. Tens of thousands of lives are benefited by tissue donation. Whole body donation is also significant. Any single event in any of these arenas affects the others. The public does not distinguish among these different areas.

Todd R. Olson

Albert Einstein College of Medicine

Seely introduced Todd R. Olson, who runs the Anatomical Gift Program at the Albert Einstein College of Medicine in the Bronx, New York, and who is also a council member of the American Association of Clinical Anatomists. He has received wide press lately as he has been speaking out against the practices that led to recent scandals in willed body and tissue donation programs.

Olson opened by saying that anatomists and the transplant community have mutual concerns: "For the past 30 years, our two fields have walked parallel paths, but our interests and differences are intertwined: Our differences are far more significant in our eyes than they are in the public's." He stated that many of his anatomical colleagues have called him to say they have been waiting for 20 years to gain a place in this forum.

He noted that the public lacks even a basic understanding of the distinctions among the different types of donation. We are all educators in respect to organ, tissue, and whole body donation. Public education and education of the media are key roles. He made a special request of the media representatives present at the meeting to tell the "good parts of the story."

In the absence of education, Olson continued, donation scandals will likely diminish public confidence in all types of donation. If it affects one school, it affects all. To ferret out the wrongdoers, it is necessary to follow the money. He specifically mentioned the scandals at the University of California-Los Angeles, Tulane University, University of California-Irvine and others that have been featured in recent headlines.

He noted that really there is nothing shocking or surprising going on. If anything, these events must be called predictable. These situations arise when people of limited means decide to ignore professional responsibilities and institutional trust for personal gain. Where does the money come from to motivate this behavior? Ultimately, Olson said, it comes down to "Physician, heal thyself."

Physicians themselves and professional societies need to step up and say that they care. They are obligated to require detailed oversight and accounting for materials used in educational programs. Ethical practices in patient care do not cease with the final breath; the need to respect the human body is at the center of the doctor-patient relationship. "As anatomists," Olson said, "we are doing a great deal. We work with willed-body programs so that those who convey material from place to place are acting in concert with donor's wishes." He mentioned some specific legislative and institutional efforts in Texas, California, New York State, and at the University of Pittsburgh School of Medicine aimed at reviewing or regulating willed-body and tissue donation programs. He referred to several articles on the topic.^{1, 2, 3, 4, 5}

Olson also spoke about the return of the resurrectionists (grave robbers). He mentioned a recent article in Harper's Magazine about modern-day resurrectionists⁶ and related the story of William Burke and William Hare who went on a killing spree out of greed in Scotland in the 1800s. Their activities were perpetrated against the citizens of Edinburgh where Hare owned a boarding house. One of his pensioners died, still owing 4 pounds in rent. Hare enlisted the help of another resident—Burke—and took the remains to a disreputable anatomist who paid them 7 pounds. Thus was initiated the monetary motivation to kill pensioners for money. Needless to say, there was great public concern and riots. In New York, the militia had to be called out under similar circumstances.

Those who had teaching materials (i.e., body parts) were able to run anatomy schools. The anatomists did not ask where the materials came from, and this is the story happening again today. Modern-day resurrectionists deal with donors who are making donations that can save lives. What is needed is a clear paper trail for body parts being used in education.

Olson offered several recommendations:

1. Expand public education.
2. Encourage information sharing regarding tissues, organs, and body parts.
3. Approve changes to the Uniform Anatomical Gift Act to deal with the rapidly expanding body parts industry.
4. Establish a national central clearinghouse for parts used in anatomical research that can serve as a go-between for sites of access and sites of need.
5. Insist that organizations involved in oversight and regulation of tissue banks approve only appropriate and legal uses of bodies, body parts, and tissues.
6. Ethical considerations must extend to the remains of those who have given to promote medicine.

Olson urged those in attendance not to let this issue go away without taking constructive action, saying, "This controversy will come to your doorstep as well."

Hon. Margaret Henbest

Idaho House of Representatives

Seely then introduced Representative Margaret Henbest from Idaho. She has served in the Idaho state legislature for 8 years. She is working to help the public understand what donation is about. She is also a pediatric nurse practitioner and has a particular interest in disclosure issues.

Henbest said that she became aware of controversy surrounding body donation about 6 years ago when she was contacted by a constituent who was monitoring the activity of a county coroner. Coroners are elected officials in Idaho and are not held to any standards. Two-thirds of Idaho's coroners are funeral directors. The constituent said that the coroner was involved in a business enterprise that was harvesting heart valves. There were legal and ethical concerns, and yet there were no laws that prohibited this practice.

She spoke about the experience of another constituent who was distraught about the organ donation surrounding the death of his daughter. The daughter had indicated prior to her death that she was willing to donate her organs, and her family wished to honor that wish. They discovered, however, that her long bones had also been procured. The family had no idea that the donation would include other tissues. They were left with unresolved grief.

Subsequently, Henbest did some research on tissue donation, storage, and the profitability of organ and tissue transplantation. She learned about the fact that the regulations governing organ donation differ significantly from those addressing tissue donation. She noted some specific concerns:

• Inadequate regulation of the tissue industry that could lead to disease transmission.
• Inadequate registration of those who handle body parts: In 1998, the requirement for registration were removed by Idaho's Department of Health and Welfare. There was no punishment for not registering.
• Extreme profitability of this industry: We must follow the money.
• Inadequate requirements for informed consent: Consent is not exclusively for organs, but for tissues, as well.
• Regulatory loopholes that allow profiteering for use of body parts research and education: There is concern because current regulations are silent on the use of body parts for research and education as opposed to transplantation, which is regulated.

Idaho rewrote the state's Anatomical Gift Act. The goal was to provide higher standards for informed consent. Henbest observed that now, "when you apply for a driver's license in Idaho, you receive a detailed brochure about how your body parts might be used, and you are advised about available resources and your rights. You can designate the exact purposes for the use of your body, tissues, and parts. Parallel information is given to families. Because we have elevated the degree of consent, we are moving toward direct consent. Donation rates have increased in our state." She noted that it is important for people to know the uses of their donated bodies. Therefore, Idaho has taken the law another step: to add a preferred designation for for-profit or not-for-profit use of the individual's body.

According to Henbest, forthcoming legislative sessions will address mandatory accreditation of tissue banks, as well as for-profit tissue and body part programs. She said that we need federal regulation so that the country does not end up with a patchwork approach. We did not anticipate all the uses for tissues and body parts when 40 years ago we drafted the Uniform Anatomical Gift Act (UAGA). She also mentioned a recent poll in England that indicated that the public is reluctant to have their DNA used in research. Another issue at the fore has been military use of bodies for testing artillery.

Henbest concluded by saying that a high tide floats all ships. We must remember this adage because the public does not differentiate. We cannot be silent any longer.

Barry Kahan asked Henbest about what types of donation have increased in Idaho since the institution of better conformed consent. Henbest replied that they have a database but have not drilled down yet to see which types of donations are increasing. She noted, however, that 15% more people have indicated via the Department of Motor Vehicles (DMV) their willingness to be a donor. Seely said that this more complex approach to consent might have decreased donations, but such is not the case apparently. Kahan observed that, in general, the more information you give people, the less likely they are to read it or to sign it. Henbest replied that she does not know whether people are reading the brochure cover to cover, but it has not been a barrier to donation.

Olson was asked about what has happened with anatomical donation in New York State since recent events. He noted that donors fall into two different profiles. Some donors do so out of humanitarian and altruistic motivation in gratitude for medical care and to advance science. The second type of donors—a significant number—donate for financial reasons. They are seeking a way around funeral costs. Some people are donating because they want to give money to their children. He observed that they are receiving more interest from people who now recognize the value of their bodies.

Henbest volunteered to provide copies of Idaho's organ donation brochure and informed consent form to ACOT. She also indicated a willingness to work on getting more data on the effects of the new legislation on donation rates.

Michael Williams mentioned an article he reviewed for Critical Care Medicine that dealt with the notion of desecration. Social, personal, and religious overtones are there. We must not forget the role of religious and faith communities. Henbest agreed that those issues constitute the underpinning for this discussion. The public is outraged when these issues come to light. We must also address the enticement of profitability. To build enough groundswell and interest, we must act in partnership with religious organizations.

Olson concurred with Henbest's comments, saying that transparency is the key. We must emphasize education and disclosure.

Ronald S. Wade

Maryland State Anatomy Board

Ronald Wade has directed Maryland's body donation program for 30 years. Wade noted that as organ transplants have became more successful, people had that alternative to consider. When he came on board, one of the first things he did was try to reorganize so that body donation became more acceptable. Historically, most bodies for study were unclaimed bodies or from tuberculosis sanitariums, but now people want to leave a legacy by improving medical care for the next generation.

Surgical study labs were set up for training physicians, shock-trauma personnel, emergency medical technicians, military medics, and others. The number of bodies used in gross anatomy is less than 300. The cause of death is not important; the donation will not be refused. "We stand by our promise to accept the donation."

The study of anatomy has changed. Courses are shorter, and some courses are doing away with dissection altogether, but there is a continuing and increasing need to enhance surgical training. To meet the need for training material, a whole gamut of body brokers and for-profit tissue banks has sprung up.

Wade said that he dealt yesterday with a university in the Midwest about a push to obtain body parts from a broker. The bodies are being obtained in the south. The State of Maryland will assist with transferring remains out of state, but the transfer must be through an institution.

It is illegal to function as a broker or deal with a broker in Maryland. Without requirements for serological testing, proper facilities, and a social and medical history, dealing with bodies and body parts is a high-risk situation. In Maryland, no surgical conferences may be held in hotels or conference centers to prevent disease transmission. Some brokers are going to funeral directors who receive finder's fees. They may even pay for use of a funeral home facility. These practices raise ethical concerns. Wade deals only institution to institution to eliminate brokers. He has a duty to the public, citizens, and the medical community to ensure that everything is done to high standards in compliance with public policy and with respect for donors and their families.

Carlton Young commented that this situation appears to be an exploding problem. He expressed concern about desecration-denigrating human bodies to the level of commodities. He noted that the transplant community is always battling over the issue of valuable consideration. How can we modify the UAGA to raise the standard?

Wade said that the legal value of a body is zero dollars. For example, it is impossible to insure bodily remains for transportation. Many people in Maryland carry organ donor cards or kidney cards. He used to conduct surveys of donors. People are aware. People are commonsensical. It is a changing culture. There is a real need in medical schools for anatomical study materials.

Olson observed that this is an international issue. Brokers can work together with funeral directors. European doctors have indicated that they acquire body parts from the United States, Romania, and elsewhere. Trade appears to go the other way as well. We need tracking systems across borders.

Wade said that uniform donor laws are being framed to have parameters for minimal standards. Regulations differ from state to state presently.

Young asked how we can support these efforts to modify the UAGA. Kress said that ACOT has done so in the past and will do so again. We need only to decide which subcommittee is the most appropriate for this work.

Susan Gunderson said that she knows little about whole body donation even though she runs an organ procurement organization (OPO). She continued, "We have come to understand tissue donation. We have our heads in the sand if we think we are immune from the fallout from unethical and illegal practices in willed-body programs."

Kathy Turrisi suggested that perhaps ACOT needs to branch out and encompass these other areas that impact organ donation. Perhaps we need to rethink our very name, which presently refers only to "organ transplantation."

A New Way of Looking at the Problem: The Burden of Disease and Its Progression

Lawrence G. Hunsicker
Henry Krakauer

Kress presented Lawrence Hunsicker, a former ACOT member who is also a past president of the United Network for Organ Sharing (UNOS) and the American Society of Transplantation. He is here today primarily because he is chair of the UNOS Data Working Group. Hunsicker has been investigating the burden of disease from a statistical point of view. Also involved in this research are Henry Krakauer, an epidemiologist, and Monica Lin, a statistician. They will describe an intriguing new way of looking at the quality of life.

Hunsicker noted that the Data Working Group (DWG) was created by the Division of Transplantation to coordinate between the Scientific Registry of Transplant Recipients (SRTR) and the Organ Procurement and Transplantation Network (OPTN) to make sure that the right data are collected in appropriate and efficient ways. The DWG is advisory to UNOS and the scientific committee of SRTR.

Analysis of transplant outcomes has so far focused on time to death and time to graft loss. Although these are clearly important outcomes, with improving patient and graft survival they are no longer the only relevant outcomes to consider. Hunsicker reviewed some reasons why it is not sufficient to consider only graft and overall survival. For these reasons, ACOT has charged the DWG with looking into quality of life issues.

The term quality of life (QOL) is not a standard or well-understood concept. There is a rationale for a new approach. For example, there is a strong likelihood that alternative outcomes such as morbidity and functional status will be highly correlated with mortality risk. Cumulative morbidity and functional status can be measured on many occasions and may offer greater statistical power in analyses. Time-series analyses on nonterminal outcomes may permit early intervention on high-risk patients.

Many years of work led by Henry Krakauer has resulted in the identification of five domains or dimensions of transplant outcomes that constitute the burden of illness. They are:

1. Mortality
2. Cumulative morbidity (adverse medical events, including graft loss and other events, primarily evidenced at least initially by hospitalizations)
3. Disability/functional status (ability to perform functions required/desired in daily life)
4. Psychological distress (e.g., depression, anxiety)
5. Resource use (effort/resources needed to care for the patient, again focusing initially on hospitalization).

Hunsicker explained for each of the five proposed domains the existing data sources, and he proposed some additional sources.

Mortality

Data on mortality are now captured by the OPTN/UNOS system and are supplemented by death data from the Social Security Master File or National Death Index. These data are quite complete.

Cumulative Morbidity

At least initially, this domain would be evidenced by hospitalization data. Limited hospitalization data are now collected on transplant recipients. The new forms will ask post-transplant patients about all hospitalizations since last reports. UNOS/OPTN collects no data about waiting-list patient hospitalizations. CMS collects complete data on kidney candidates and recipients who have Medicare primary coverage. As a starter, the DWG has obtained consent from Pennsylvania and Virginia to get comprehensive hospitalization data on transplant candidates and recipients from those states. Transplant centers do not have these data.

Functional Status

UNOS/OPTN collects functional status information on transplant recipients at transplant and on follow-up forms, but for transplant candidates, the data on functional status is collected only at the time of registration. Although these data correlate with outcomes, the grading is not sufficiently granular to capture less-than-gross loss of function. Nevertheless, these data may be useful because they are highly predictive of mortality.

The DWG proposes to capture additional information on functional status in a pilot study using the SF36 physical status scale and replacing the current UNOS functional scale (The New York Heart Scale — four points) on the transplant form with the Karnofsky Index. The Karnofsky Index (Figure 1) represents 11 levels of function ranging from normal to minor impairments that do not adversely affect function to a moribund state to death. It is the standard, best validated objective scale for functional status, and it can be completed at the time of patient clinic visits in less than one minute.

This proposal was discussed at the Data Advisory Committee meeting in late April. This will not be an effortless change. Someone will have to collect the data and complete the scale during clinic visits. Vanderbilt University has been acquiring Karnofsky data for some time.

Figure 1. The Karnofsky Index

Psychological Distress

Presently, no data are collected by UNOS/OPTN on this domain. The DWG proposes to collect this information from the SF-36 mental health subscale. This instrument is widely used to assess mental and psychological status.

Resource Use

UNOS/OPTN currently collects no data on this domain, although NOTA charged OPTN and SRTR with collecting financial data on the costs of transplants. At least initially, the DWG proposes to focus on hospitalization resource use by estimating from hospitalization data the effort needed to care for the patient. The basis will be uniform coding based on DRG weights and length of stay.

For which patients do we need to track these five domains? The benefit of the transplant is the total difference between projected outcomes based on whether the transplant is performed or not performed. In addition, we should think about including those who are not transplanted but live with chronic disease. That issue, however, is outside the scope of today's discussion.

Hunsicker made it clear that there is no intent for the proposed analyses to force any particular approach to the formulation of deceased donor organ allocation or other UNOS/OPTN policy. The proposed approach to analysis will simply inform UNOS/OPTN committees more broadly about the outcomes of transplantation. The Board and the Committees are free to use the information as they deem appropriate.

To what extent will these domains correlate with morbidity and mortality? It is conceivable that many patients who receive lung transplants, for example, do not have longer lives but their QOL post-transplant may be very much greater. In any event, a person who is considering a lung transplant may wish to look at the impact of transplant on survival and functional status. The best approach for analysis, then, may be combination of multiple outcomes in a model with a multivariate outcome. That is, outcomes in all five domains can be considered as a single vector (per individual). In this approach, the mutual correlations among the outcomes are observed directly (as the covariance matrix) in the analysis. This approach is objective and leaves weighting to policy makers and patients.

Using combined analysis of multiple outcomes may be leading the way for the rest of the health community, but it is not a slam-dunk. Not all groups may wish to pursue this line of thinking. Others may wish to work out different approaches. Let many investigators look at these data using different analytic approaches.

In addition, different analysts may have different goals. Some may strive to optimize use of limited resources (organs or funds); others may seek to optimize outcomes for a particular patient.

Analyzing Multiple Outcomes for Transplant Candidates and Recipients

Robert Wolfe

The Data Advisory Committee is looking at several different mathematical approaches, according to Robert Wolfe. We are looking at the benefit of transplantation although it involves many different outcomes. Wolfe listed two rate measures (mortality, hospitalization) and four scaled measures (days in hospital, resource use, functional status, and psychological distress). Scaled measures are determined at different points in time and then the averages are weighted.

Wolfe also said that analyses will continue to be done as they always have been; the multiple outcomes model will be an addition. Traditional methods for modeling combined outcomes are based on the following tenets:

• Outcomes are often correlated. Patients high on one outcome might be high on another.
• Correlation can arise from shared measured characteristics: Covariates predict multiple outcomes. For example, diabetics have both high hospitalization and high death rates.
• Correlation can be modeled with regression: One outcome predicts another. For example, mortality can be predicted by recent hospitalization and recent low functional status.

Wolfe highlighted two innovative methods for analyzing correlated outcomes. First, frailty models introduce a patient specific covariate to account for correlation. Frailty is an unmeasured covariate that predicts the outcomes of interest (rates or means). The frailty for each patient is imputed to fit the outcomes for that patient. Second, Bailey, Krakauer, and Lin have developed an innovative method to analyze correlated outcomes.

Modeling the Components of the Burden of Disease

R. Clifton Bailey

Clifton Bailey said that an analytical plan is needed for collecting and analyzing data. We have chosen to use each component as a cumulative measure, but the problem remains of how to put the measures together. A probability summary is a consistent way of dealing with these outcomes — morbidity, mortality, and resource use. We use mathematical representations to capture the essence of these components (domains). It is necessary to deal with the correlations conjointly.

He showed several graphs, including the declining hazard pattern of post-transplant mortality. The risk of dying is very high immediately after a procedure, and then the risk declines. Post-listing mortality has a different pattern of increasing hazard. The post-transplant morbidity curve rises and then falls.

When modeling, they make use of the explanatory variables that they want to model. Morbidity and resource use could be modeled in any of several different ways. In every case they have used the cumulative distribution form. Each of those, in turn, is made to depend on these explanatory factors. Therefore, the correlations output by the model will be case-specific. For example, they may arrive at one set of correlations for diabetics and another set for nondiabetics.

Trivariate Multiple Outcomes Model

Monica Lin

Monica Lin discussed how data were developed for applying the trivariate, multiple outcomes model. The focus has been on the post-transplant period. The data set is based on a cohort of Medicare-eligible patients listed in 1996 and followed until the end of 2000. Transplants are included only if they occurred prior to 2000 (minimum of 1 year of post-transplant follow-up. Data sources are:

• OPTN: Data on patient characteristics at listing and transplant, and on disability (from the follow-up form).
• USRDS: Data on hospitalizations from consolidated OPTN and Medicare data (sole source on experience on dialysis).
• Medicare: SS Death Master File. Data on hospitalizations (morbidity and resource use).

The model may provide an evidence-based, objective answer to the question posed by many patients, "What will happen to me?" Estimates are made by simultaneously modeling survival, resource use, and morbidity.

Among the questions that the model could address include these:

• Benefit: What is the outcome for the average patient with and without transplant?
• Subgroups: What differences are there among different patient subgroups?
• Policy 1: Which patient currently on the list is likely to benefit most from receiving this organ?
• Policy 2: How would outcomes be changed by proposed policy changes?
• Individuals within subgroups: How much variation is there among individuals?
• Correlation: Are the individuals who are at high risk for one outcome also at high risk for other outcomes?

The DWG is continuing work on simultaneously modeling of four outcomes and is also looking into waitlist outcomes. A paper has been submitted to the American Journal of Transplantation.

Some discussion ensued. Hunsicker made a point about distinguishing between policy formulation and the personal decisions made by patients and their doctors. OPTN focuses on policy, but ACOT may wish to take a broader view to reflect patients' preferences. Discussions about possible outcomes occur all the time between transplant surgeons and their patients, but there have not been any data to inform these discussions. These data allow the patient to make decisions about the tradeoffs involved.

According to Hunsicker, the Data Advisory Committee (DAC) was concerned about the additional burden on transplant centers that would result if the Karnofsky Index were adopted, although the vote was 18-2 in favor of adopting the Karnofsky index. DAC proposed a pilot study for collecting SF-36 data that would involve random sampling with oversampling of certain subgroups. Centers will not need to get separate Investigative Review Board (IRB) approvals.

Nancy Ascher asked if the analysis takes into account a center effect. She suggested simplifying the language describing the model and she recommended that in order for patients to weigh risk and benefit, the center effect becomes paramount. Hunsicker replied that the model is not intended to look at center effect. He agreed that the model might be improved by incorporating center effects.

Barry Kahan said that it could be an onerous task to collect data. He asked if it would be possible to go to a pharmaceutical company and test some of the hypotheses with data that have already been collected on existing cohorts.

Hunsicker replied that the only burden will be associated with the letters and consent forms patients receive regarding the Karnofsky index. Some patients will ask about the letter they will receive. The consent letters will be very detailed. He also said that in regard to conducting a retrospective study that the existing cohorts are not very standard.

Kahan said that in virtually every clinical study, we have already collected Karnofsky and SF-36 data. We could set up two study arms and test the models.

Hans Sollinger noted that clinical practice is evolving very quickly. We have learned how to deal with extended donors. We can almost equalize outcomes using various protocols to conserve kidney function. It is a challenge to keep up with these radical changes in our clinical approaches. Looking at retrospective data would be a useful scholarly practice, but to base clinical decisions on old data could be perilous.

Flora Solarz said that with the growing waitlist, we do not know what outcomes we are promising our patients. We need to look at this seriously and weigh the ethical implications. We talk much about informing patients and that is what this discussion is really all about. Resource use seems parallel to hospitalization. It may be more useful to consider resource utilization by the patients than by the hospitals. Another danger is that predictions about hospitalizations could raise the eyebrows of insurance companies when they decide who will be transplanted.

Hunsicker (to Sollinger) said that collecting the data does not necessarily mean that a recommendation will flow from it. The present is always different from the past, but we cannot just throw away those data. We are always better off knowing something than not knowing something. Regarding Solarz's comments, he said that it would be very useful to know something about the individual's costs in terms of resource utilization, but we have to look at the costs we can get at more easily.

Kathy Turrisi noted that, in the past, staff at the center were the ones who completed the Karnofsky or SF-36 forms. It would be more useful if the patients themselves were asked for their input on the forms. Hunsicker replied that the plan is to mail out the full SF-36 forms to the patients because the centers do not necessarily know how the patients are doing. The Karnofsky Index would be done by the centers. We will have to carry out a fair bit of education to get the forms filled out correctly.

Young urged caution because if we hone things down too precisely, we may think we know what's best. If the model outcomes are memorialized as policy, might patients be denied transplant because of the potential for poor outcomes due to their race, co-morbidities, or other factors? It could get so burdensome that we will not transplant because of potential risks. We must be very careful because the data could be misused.

Michael Williams expressed reservations about using specific percentages in patient discussions. These are just probabilities. We need to present data in useful ways. Trouble arises when patients are promised specific outcomes. It is best to say that we will try our very best, but here are the risks.

Hunsicker said that having the data would help inform these discussions. For example, with livers we have found that the sickest patients are not futile transplants; this is the group that actually receives the most benefit from transplantation.

Robert Gibbons congratulated the group for looking at a broader field of outcomes. We are already using statistical models albeit inefficient ones for making transplant decisions. For example, the Model for End-stage Liver Disease (MELD) is based on a univariate model. We need to continue in this path to look at multivariate outcomes.

Amadeo Marcos said that we cannot continue using only patient and graft survival as outcome measures. The issue is to do what is best for patients. What is the weight that will be given to each factor? Policy decisions will continue to be made by the various appropriate committees of OPTN.

Three Decades of Struggles and Triumphs: Reflections on 30-Plus Years of Transplantation

Clive O. Callender

Clive Callender is the founder and head of the Minority Organ and Tissue Transplantation Program (MOTTEP). He has performed more than 300 kidney transplants. He left Minnesota in 1973 and started the program at Howard University. He shared some of his ideas and thoughts as he reflected back on his 30-year career.

Callender identified 14 critical issues facing the transplantation community:

1. Organ donor/organ recipient disparity: As of January 2004, this disparity represents 60,000 people. More than 16 people die daily because of the organ donor shortage. Callender said that the situation seemed hopeless when he started because African Americans used to donate organs at lower rates than other ethnicities because of many factors. This trend, however, has changed. Minorities, who represent 25% of the American population, made up 15% of donors in 1990 but comprised 28.5% of donors in 2000. In 1990 the organ donor/million rate for Blacks was 22.4; in 2000 it had risen to 40.8.
2. The Green Screen: The Green Screen is a symbol for the lack of dollars or medical insurance or the ability to pay for health care or the medication necessary to sustain the health provided by transplantation. African Americans constituted only 10% of those waiting for livers in 1995, yet African Americans die more frequently of liver failure than do Whites. "If you didn't have the green, you couldn't get on the waitlist and you would die." The role of the Green Screen in renal transplantation is undefined, but it must exist because people are denied transplants due to a lack of means to pay for post-transplant immunosuppressive therapy. Callender mentioned the film "John Q." The Green Screen is underappreciated as an obstacle to transplantation. We are all accountable because we won't approve the taxes necessary to pay for transplants for those of limited means.
3. Prevalence and incidence rates for kidney failure in Blacks (African Americans) and other minorities: The incidence and prevalence rates of end-stage renal disease (ESRD) for Blacks (African Americans) and other minorities are disproportionately high because of their increased susceptibility to diabetes and hypertension (twice that of Caucasians).
4. Disproportionate effect of human immunodeficiency virus (HIV) on Blacks (African Americans) when compared to Caucasians: It is not clear why the nephropathy of HIV is so largely a problem of African Americans. Blacks (African Americans) with HIV experience HIV nephropathy at 10 times the rate of other ethnic groups. In fact, 93% of all AIDS nephropathy cases reported are in African Americans.
5. Dialysis survival rates for Blacks: Blacks have patient survival rates on dialysis that are superior to Caucasians. Callender discussed some data regarding 1-year and 2-year mortality rates of African American and Caucasian ESRD patients on dialysis, showing that African Americans do much better on dialysis than do Caucasians, but is this good news or bad news? The USRDS report demonstrated that healthier blacks remain on dialysis whereas healthier whites are transplanted. This is really a negative data item. We cannot compare until transplantation rates are equalized.
6. Race and science: Callender emphasized the need for completely replacing the term "race" with the word "ethnicity" in science. The human genome mapping project demonstrated conclusively that all humankind, Homo sapiens, belongs to one race. This finding once and for all makes it clear that in science the issue of race is an illusion that must be done away with. Using "race" is divisive and renews the sociopolitical construct that denies the positive aspects of each ethnic group and reenergizes the superior/inferior designation. We are all one race with different ethnicities. This change must occur throughout the scientific community, the U.S. Census Bureau, and the Office of Management and Budget, until the term "race" is replaced by ethnicity in all scientific journals and census data.
7. Compliance rates for Blacks: Blacks and Latinos are no more noncompliant than other ethnic groups. The groups that are least compliant are adolescents and health care professionals!
8. Unique post-transplantation drug responses in African Americans (Blacks): Blacks after transplantation metabolize transplant medications differently than Caucasians and other ethnic groups, thereby altering their responsiveness to these medications. One of the reasons is that Blacks are more immunoresponsive than other ethnicities. One study showed that 90% of African Americans were hyperimmune in contrast to 66% of Caucasians when pre-transplant immune responsiveness is studied. Therefore, it is clear that Blacks require more powerful immunosuppressive therapy than other ethnicities. In addition, cyclosporine is poorly absorbed in Blacks. Prednisone's side effects (hypertension, diabetes, and obesity) tend to be especially problematic for African Americans. Blacks have to pay more to get effective doses of Cellcept because the effective dose for African Americans is higher than for Caucasians. In many instances, gastrointestinal and bone marrow intolerance are problematic for African Americans. The necessity of using lower doses may increase the likelihood of acute rejection episodes. Tacrolimus — one of the most potent immunosuppressants — is associated with the development of posttransplant diabetes at twice the rate in African Americans and Latinos than when it is used in Caucasians. In addition, development of insulin dependence tends to be permanent in African Americans in contrast to the situation with Latinos and Caucasians who generally experience reversible insulin dependence. Part of the reason may lie in genetic differences in the P450 cytochrome oxidase system or in the higher level of immune responsiveness of African Americans. Elucidation of this enigma may improve graft survival for African Americans.
9. Delayed transplantation referrals for Blacks and other minority patients: Blacks are referred later for kidney transplants, are placed on the waitlist later, and are transplanted later than Caucasians, regardless of financial status. Callender referred to the work of Alexander and Sehgal⁷ who objectified and, for the first time, put in print what had been suspected for some time: Blacks, women, and poor people encounter barriers to transplantation. Danovitch, Cohen, and Smits⁸ propose using the European (Eurotransplant) model, which defines waiting time as beginning when the patient begins hemodialysis in an uninterrupted fashion. This simple change would level the playing field in regard to delayed referral times for African American transplant candidates.
10. Waiting times for Blacks and other minorities in transplantation: Waiting times for kidneys are twice as long for Blacks and other minorities as for Whites. A study by Roberts et al.⁹ shows that we have made some improvements in transplantation rates for Blacks, but we still have a long way to go.
11. The fate of kidneys and other organs transplanted into Blacks: African Americans after transplantation of kidneys and other organs have 10% to 20% poorer graft survival rates than all other ethnic groups (at 2–5 years after transplantation). This trend is evident whether the organ was recovered from a living related donor, living unrelated donor, or a deceased donor. Why is not known. In 1977 Opelz et al.10 first reported that kidney donor and graft survival rates in African Americans were the poorest among all ethnic groups. A subsequent analysis of the OPTN/UNOS database showed that Black recipients of deceased donor or living donor kidneys were associated with statistically significantly poorer graft survival regardless of donor ethnicity. Black recipients of deceased livers and hearts had significantly lower graft survival rates when receiving organs from Whites, Blacks, or Latinos. The reasons for these ethnic differences are unknown. When looking into half lives for kidney transplants across all ethnic groups, it can be seen that Asians have the most favorable half lives and African Americans have the shortest half-lives (living or deceased donor transplants). It had been hoped that increasing the numbers of black donors would increase graft survival, but that may not be true. Many hypotheses have been offered and disproven (e.g., too few black donors, HLA mismatch, inequitable distribution). The negative correlation of hypertension, hyperimmune responsiveness, and institutional racism seem clear. Why hypertension is such a highly negative correlate remains a mystery and should be a focal point for research and study. The newest immunosuppressive regimens may provide some answers. The most hopeful and most correctable problem is institutional racism. There is a need for changing lifestyles and thereby reducing the need for organ transplantation. MOTTEP is already addressing this.
12. The fate of donated African American kidneys and other organs: When African American organs are transplanted into African Americans or Caucasians, they have significantly inferior graft survival. Black to black donation has the highest relative risk of graft loss (kidney or liver). African American kidney donors survive for shorter periods than all other ethnicities. It would be inappropriate to recommend, however, that all organs donated by African Americans should be considered high risk. The data reflect the need for more research. We do not understand the reasons for the graft survival disparity, nor do we have a strategy to overcome this.
13. Inequitable allocation schema: Inequitable, discriminatory allocations were the consequence of HLA antigen matching at the A and B loci. The work of Roberts et al. was instrumental in ending a system that was ethnically discriminatory to Blacks since 1989. UNOS abolished antigen matching at the HLA-A locus by 1994 and the B locus by 2002. Eliminating these criteria has increased public trust in the donation and allocation processes.
14. The effects of institutionalized racism: Deep-rooted conscious or subconscious classifications of ethnic groups into superior and inferior classes may be the most important obstacle to overcome to eliminate transplant health disparities. "Institutionalized racism" is a term that is unrecognized in the field of ESRD or transplantation. To say it is taboo is an understatement. Yet, as we look at the disparities discussed previously, it appears that few items are as pervasive or as understudied as the phenomenon in this field. The human genome project has made it clear that we are all the same species, yet this insidious attitude persists. The pathophysiologic consequences of institutionalized racism have been demonstrated by Jules Harrell¹¹ and others since 1982. Institutional racism is likely responsible for the longer waiting times for Blacks compared to Whites for kidney transplantation, delayed referral of Blacks for kidney transplantation, Blacks receiving kidney transplants later than Whites, and Blacks being referred later, if at all, for extrarenal transplants.

Callender recommended the following actions for eliminating ethnic disparities:

• Provide adequate funding for further research into the 14 highlighted areas.
• Allocate an additional $200 million to the National Center on Minority Health and Health Disparities to address research questions and help eliminate the disparities in transplantation and donation.
• Eliminate the word "race" and replace it with the term "ethnicity" in the science and health arena and in the federal government.
• Develop a national strategic plan with goals and implementation dates with a community-based effort to eliminate institutionalized racism by educating and empowering the minority and majority communities.
• Encourage the involvement of the minority communities in health prevention activities to help ameliorate the need for organ transplantation.
• Develop an empowered minority community and enlist its support in changing behavior that fosters institutionalized racism.

William Harmon noted that one of ACOT's first recommendations to the Secretary was to support research into ethnic disparities.

Turrisi said that, in Charleston, it has been her experience that many African Americans have not been managed aggressively for hypertension and diabetes. That may be an early factor. We are starting to look at those disparities. Callender observed that we are not treating post-transplant hypertension properly either. Right now we have abject ignorance. We need a strategic plan to address it.

Roger Evans asked why Callender is using the word "disparities" instead of "inequities." Callender said that it is the same thing. Evans replied that the word "inequities" implies a cause. Disparities is just politically correct. We all want all Americans to have successful transplants. What helps one group helps the others.

Fritz Port made the point that three disadvantaged antigens are more common in the African Americans than in Whites. When we combine dialysis and transplantation and adjust for diabetes, hypertension, and age, we find that blacks have better outcomes. It is a profound observation, which we need to analyze further.

Recent Congressional Action

Emily Marcus Levine

The Organ Donation and Recovery Improvement Act (formerly the Frist Bill, now Public Law 108-216, an amendment of the National Organ Transplant Act (NOTA) passed Congress overwhelmingly and was signed into law by the President on April 5, 2004.

The Act expands the Secretary's authority to improve donation and transplant system and symbolizes Congress's recognition of the importance of these issues.

Section 3 of the Act may be of particular interest to ACOT. By way of background, Section 301 of NOTA makes it illegal for any person to "...knowingly acquire, receive, or otherwise transfer any human organ for valuable consideration..." Statutory exclusions include "...expenses of travel, housing, and lost wages incurred by the donor of a human organ in connection with the donation of the organ." The Organ Donation and Recovery Improvement Act authorizes the U.S. Department of Health and Human Services (HHS) to disburse grants ($5 million per year for 2005–2009) to reimburse living donors for allowed expenses. This is payment of last resort. The Secretary may also pay such expenses for up to two people to assist the donor. Preference is to be extended to people whom the Secretary determines are least likely to otherwise meet expenses.

Section 4 deals with public awareness; studies and demonstrations. This section establishes new grant/contract authorities and provides for a public awareness program to be overseen by the Secretary directly or administered through grants/contracts. This section also addresses the need to educate the public and generate awareness about the need for donors. Some programs already exist, but this provision will be supplementary. Also included in this section is authority for issuing peer-reviewed grants/contracts with the intent to conduct studies and demonstration projects for both deceased and living donors.

Section 4 also gives new authority to issue grants to OPOs and hospitals (must be trauma hospitals and those serving populations of 200,000 people) for the purpose of establishing programs to coordinate organ donation activities to increase donation rates. This measure will help states in their efforts to increase donation. Finally, there is an educational activity section. HHS will develop educational materials to inform health care and other professionals on donation issues. These programs must coordinate with OPTN and other organizations.

Section 5 confers new authority on the Secretary, through the Agency for Healthcare Research and Quality, to develop scientific evidence in support of efforts to increase donation and improve the recovery, preservation, and transportation of organs. The Secretary is authorized to conduct or support research, carry out a review of the scientific literature, develop and adopt proven practices. Other activities mentioned include research and dissemination of findings, development of a uniform clinical vocabulary for organ recovery and so forth, enhancement of skills in the workforce, and assessment of technologies.

Section 6 directs the Secretary to report to Congress on transplant-related activities under NOTA. The report is to discuss which activities have affected rates of organ donation and recovery and must include an analysis to evaluate the effectiveness of activities. The practices to be covered are to include those of the states, organizations, and other countries. The initial report is due in 2005, and subsequent reports every 2 years thereafter. The 2005 report must:

• Address donation practices for most effective practices and existing barriers
• Evaluate living donation practices
• Evaluate federally supported and conducted efforts
• Evaluate state registries
• Include a plan to improve federally supported and conducted activities.

Section 7 authorizes the Secretary to establish and maintain mechanisms to evaluate the long-term effects associated with living organ donation.

Section 8 is likely to involve ACOT in meaningful ways. This section directs the Secretary to evaluate proposals to increase cadaveric donation and report to Congress on those proposals. The Secretary must consult with the community (advocacy groups representing populations likely to be disproportionately affected by proposals). The report is due by 12/31/2004. Kress noted that there is likely to be a role for ACOT in the development of this report, which he referred to as the "Section 8 Study." He reminded the group that this meeting will result in direction and guidance to the Subcommittees. The recommendations coming out of the November meeting will then have to be addressed quickly in order to roll those recommendations into the Section 8 Study.

Section 9 repeals section 371(a)(3) of the Public Health Service Act (part of NOTA), which gave grant/contract authority for special projects designed to increase the number of donors. It had been relied upon by HRSA's Division of Transplantation but has now been replaced with more expansive authorities and a larger pool of eligible entities.

Levine noted that the new law does not address the controversial valuable consideration issues under section 301, nor does it appropriate any funds. (Funds were only authorized.) Language was struck from Frist's original bill about demonstration projects to test incentives that otherwise might be barred under NOTA section 301.

Progress Report on the HHS Breakthrough Collaborative and the Latest Secretarial Organ Initiative

Dennis Wagner
Virginia McBride

Dennis Wagner told the story of the Breakthough Collaborative and shared the broad outline of the YIELD initiative, which is aimed at increasing the number of organs transplanted per donor.

The Organ Donation Breakthrough Collaborative is "committed to saving or enhancing thousands of lives a year by spreading known best practices to the Nation's largest hospitals to achieve organ donation rates of 75% or higher in these hospitals." Wagner noted that the involvement of the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) in the Collaborative is largely due to ACOT's work.

A collaborative is an intensive, full-court press to facilitate breakthrough transformations in the performance of organizations, based on what already works. The methodology can be implemented in a variety of issues and arenas. In particular, the goals of the Organ Donation Breakthrough Collaborative are to:

• Increase the average conversion rate of eligible donors from the current average of 43 percent to 75 percent in the Nation's 300 largest hospitals
• Increase donations by up to 1,900 donors per year
• Increase the number of transplantations by 6,000 per year
• Help save the lives of thousands of people each year and prevent up to 17 deaths per day.

Wagner noted that 50% of eligible deceased donors are found in 223 hospitals; 90% are found in 953 hospitals. When one examines 1-year conversion rates among the largest 300 hospitals, conversion rates range from 10% to more than 90%. Most cluster around the national average of 40% to 50%.

The Collaborative has conducted site visits at six top-performing OPOs to develop a menu of practices that generate high conversion rates. Wagner showed a slide of conversion rates by donation service area (DSA). The average rate goes from more than 80% to 30% or less. This is not a case of being clumped around the average.

The Collaborative team consists of about 500 people at 95 large hospitals and 42 organ procurement organizations. The faculty includes 13 leading practitioners from OPOs and hospitals that have high conversion rates. Also, a leadership coordinating council supports the Collaborative. (Several council members were present in the room, including several members of ACOT.)

The Collaborative functions within a framework of learning sessions. Learning Session 1 (LS1) is dedicated to the study of change concepts and the Deming PDSA model (Plan, Do, Study, Act). LS2 encompasses more PDSA cycles. LS3 is dedicated to sustaining progress. The LS4 meeting will probably be held in November. Each team reports monthly. The learning sessions were also broadcast via satellite to large hospitals across the county to enable remote participation.

Susan Gunderson shared some of her insights gained as a result of her experience with the Collaborative. She said it has been very helpful to get hospital people together with OPOs so we are looking at the common problem and seeing how we can work together. The other real benefit is information sharing. The information is really used to bring about practice change. It is timely and helpful. She also spoke about the benefits gained by bringing the other players to the table (e.g., JCAHO, American Hospital Association) to hear their views on organ donation. She admitted that the Collaborative is an enormous amount of work.

Michael Williams spoke about attending the first Collaborative: "We learned that our effort was designed to bring together transplant coordinators, nurses, and physicians to work together." He cautioned, however, that it may be difficult to isolate effects of the Collaborative versus other interventions, perhaps confounding data collection and analysis for other studies.

Mike Seely said that the energy generated by the Collaborative is infectious. "Everyone is coming together to solve problems." He attended the learning session in Dallas and was struck by the size of the group. He observed that, historically, all these groups have been working in silos. "It is an eye-opening experience for OPOs to be at a table with their hospital peers." The Collaborative makes very effective use of the open space technique.

Virginia McBride then spoke about the results of the Collaborative's Action Period 2. She noted that the Collaborative in many respects carries out Acot Recommendations 12-16. Specifically, for example, ACOT's recommendation 16 states that "the regulatory framework provided by the Center for Medicare & Medicaid Services (CMS) for transplant center and OPO certification should be based on principles of continuous quality improvement. The Collaborative's work is not research. It is indeed continuous quality improvement.

The Collaborative has a few process measures:

1. Timely notification within 1 hour of a mutually established clinical trigger over the number of imminent deaths, expressed as percentage. The clinical trigger could be, for example, a Glasgow Coma Scale of 4 or a determination that care has become futile.
2. Appropriate requester. The number of cases in which a designated requester met with families over the total number of requests made, expressed as a percentage. We have found that it is not a matter of who makes the request but that the family has received information and support so that they are comfortable with the decision when that time comes.

McBride showed a graph (Figure 2) of these process measures. Timely notification among Collaborative members is up to about 80%; the appropriate requester rate is up to about 90%.

D

The bottom line metric is the conversion rate, defined as organ donors over eligible donors, expressed as a percentage. Stated otherwise, the conversion rate represents consented donors from whom an organ is recovered for the purpose of transplantation including non-heartbeating donors and donors over the age of 70. This measure is not about OPO performance. This measure reflects how well hospitals are setting up donation situations. Conversion rates bounced around. We need to get a conversion rate above 62% to see a statistically significant difference as a result of the Collaborative.

Some Collaborative teams achieve 75% conversion rates during some months, but we need to get more teams to that level. October set the record; January broke the record for organ donations.

McBride listed Collaborative hospitals with 75% conversion rates. She mentioned the achievements of St. Joseph's Medical Center in particular.

D

D

McBride described a new metric for the Collaborative — the number of donors before a non-donor — that is, the frequency with which successful donation events are interspersed with unsuccessful events. This measure is intended to help teams recognize when they are maximizing successful donation events. The goal is to keep a string of donors going.

The theme of LS3 was, "What does your team need to do to get to 75%?" Teams must reduce the number of non-consents. This must be a team focus for testing and changes. The number of non-consents has not changed much. To change consent rates, the system must change. McBride identified some high-leverage changes that have been implemented by successful teams:

• Use a synergistic combination of strategies to get to 75%.
• Acknowledge organ donation advocacy as an appropriate family support objective.
• Seamlessly integrate OPO and hospital roles and responsibilities (ACOT's Recommendation 13).
• Capitalize on the strengths of an integrated and flexible organ donation team.
• Follow early referral with rapid response (ACOT's Recommendation 15).
• Establish and manage an effective requesting process.

For every learning session, the Collaborative identifies teams that are succeeding. Then film crews are deployed to document those practices. A set of about 20 videos is available now to be used as resources for participants to bring back to their home hospitals.

Wagner spoke about the strategies being developed to spread Collaborative successes. He identified two key aspects of spread strategy development:

1. Get results from this collaborative.
2. Create and nurture the infrastructure and support network for extending the momentum of the collaborative.

Key elements of the spread strategy include:

• Sustaining support for current teams through the third action period and the fourth learning session.
• Supporting the leadership coordinating council.
• Conducting a learning session in September 2004 to bring in 200 new organizations which will overlap with the first collaborative so there is a mentorship opportunity.
• Supporting a network of spread leaders.
• Building and operating a knowledge management system.
• Making learning sessions available via satellite.
• Conducting a "National Learning Congress."

The Collaborative is ready to spread information on mutual accountability, the 75% conversion rate target, the model for improvement and small testing cycles for achieving changes, process measure improvement, and high-leverage changes that generate team conversion rates greater than 65%. Wagner cited the success of the Collaborative's work on donation after cardiac death (ACOT's Recommendation 13). Results were achieved quickly. After the learning sessions, hospitals went back and immediately formulated policy and got their first DCD donors during that cycle.

He also spoke about the YIELD initiative and its goal of achieving an average of 3.75 organs transplanted from every donor. He identified two strategic aspects of the Collaborative's work to increase yield:

• Improved use of technology
• More knowledge about practices already in use to achieve higher yields and then promotion of those practices.

Key audiences for the YIELD initiative are OPOs, transplant surgeons/physicians, and the critical care/intensivist community. The initiative's timing is opportune. The Secretary is strongly behind this initiative, which builds upon the momentum and national learning community generated by the Collaborative. Technology is available to support the initiative, and leadership organizations are already on board.

The Collaborative plans to implement a study to identify best practices of those who have high yields and involve key practitioners in the study. An expert panel of practitioners will be convened to vet and refine study findings. A HRSA/UNOS technology summit will be convened to review and refine performance guidelines for technological improvements. Data, practices, and the summit findings will be used to inform guideline development.

Wagner asked the group for insights and ideas about the Collaborative's spread strategy and YIELD Initiative. Sollinger said that the Collaborative is the most exciting thing in this field. He appreciates that it is designed to measure success. He suggested, however, forming a task force to see why these big centers are not big producers.

Ascher said that she receives a "report card" every 6 months about how her center is doing, and how its affiliates are doing. "Donation Dashboards" were distributed to show where their numbers were.

Harmon said that being a good organ donor hospital could be a public relations nightmare. It may be a dubious distinction to be the best organ donor hospital. Gunderson said that they do recognize their top donor hospitals. The hospitals were pleased and proud that they offer this service to families.

Williams said that it is important for physicians to talk through their feelings of failure and improving donation rates. He emphasized the difference between a values-based approach for making changes versus the compliance-based approach. People become resistant to change with the compliance-based approach. People must want to make the change.

Gibbons asked how hospitals were selected for the Collaborative. Wagner responded that two key criteria were involved: They had to be large hospitals and they had to demonstrate a high level of commitment.

Gibbons made several suggestions about improving data analysis. He suggested that using a method to show cumulative changes will be much more likely to show positive effects. Use methods designed to show trends. Model the factors that work together to improve rates. Use strengths to focus efforts. Others involved in the Collaborative emphasized that the function is not to demonstrate statistical differences but to identify and implement best practices.

Kahan noted that if a patient in the emergency department appears to be indigent, there may be a reluctance to intubate the patient and transfer him or her to the intensive care unit because if the patient does not become a donor, the hospital is stuck with the charges.

One participant said that it is unusual for large transplant centers to be major donor centers. It seems to be a conflict of interest. If the transplant folks support the donation piece, it is problematic. Williams responded that it is necessary to have firm, written policies for determining brain death. There has to be a separation between those who determine brain death and those involved in donation. There are easy ways to handle the conflict of interest. You need the right people.

Delmonico asked if a definition of eligible donors has emerged. There may be fewer brain death diagnoses being made. McBride said that they have a definition that is consistent with the OPTN's definition. Through the Collaborative, the number of eligible donors has increased. Kahan said that is very interesting. Some of us in the field think the opposite. This clearly deserves appropriate scientific study. We need to look at that carefully. If the minority of our donors progress to become brain dead donors, we need to know that.

ACOT Valuable Consideration Subcommittee (A)
Breakout Session

Members:

Nancy Ascher
Gail Agrawal, chair
Phil Berry
Bob Charrow
Roger Evans
Susan Gunderson
Larry Hagman
Barry Kahan

Other participants: Robert Merion, Josh McGowan, Emily Marcus Levine, Ronn Wade, Mary Ganikos, Mark Nadel

Presumed Consent

Phil Berry led a discussion of this topic. He is himself a liver recipient. Over the last several years, he has begun speaking out about organ donation. He has been frustrated by the length of the waiting list, which has more than 80,000 people on it now. He has been frustrated by seeing so many good people trying to do good things. The gap is growing because the length of the waitlist is far outstripping the number of organs donated. An article ¹² was circulated among the Subcommittee members about an opt-out, presumed consent system. Berry said that the more you ask people to do, the less compliance you will get. The systems that tend to work are the ones in which people don't have to do something. The article described the results of an online survey conducted via email.

Berry compared opt-in and opt-out systems: In an opt-in system, if you fail to sign an organ donor card, the default is that no organs are taken upon your death. In an opt-out system, the default is that you will be an organ donor unless you have taken action to indicate that you do not wish to become an organ donor. According to the article, the survey indicated that the effective consent rate under an opt-in system would be 42%. Under an opt-out system, the effective consent rate would be 82%. Eighteen percent indicated that they would opt out of being an organ donor. It was an interesting study. These data and those of Gimbel suggest that a change in our default would provide thousands of organs each year. The consequences would be powerful. Defaults do make a difference.

In summary, Berry urged the group to continue to look at every avenue we have to increase organ donation. We cannot continue beating our heads against the wall. We must consider an opt-out system. The American Medical Association held an ethical discussion around incentives for donors. We don't know, but we need a demonstration project to study the effect of financial incentives to find an answer. Demonstration projects could be undertaken by states that have an interest in doing this. We could encourage those that are willing to try. We should commit to it for a year or two or three. I hope we are open enough that we don't keep thinking that more education, or this or that, will make a difference. Nothing is changing the path we are on.

Barry Kahan made that point that, in Spain, they still ask family permission and do not go against the family's wishes. He asked Berry to summarize what is going on in Texas where there was an attempt to get the legislature to endorse presumed consent.

Berry said that Spain attributes their high organ recovery rates primarily to having in-house OPOs. In Houston, there is a close alliance with OPOs in-house to ensure that organs "do not fall through the cracks." Houston is one of the top five procurers in the country. The number one recommendation is that we should try presumed consent. He doubts that more than 2% of the legislators read the report because of a lack of interest. It would behoove us to revitalize that report. California has talked about a bill to introduce presumed consent.

Gail Agrawal asked about what points the Subcommittee should present to ACOT. What are the responses we can anticipate? What are the legal impediments as to the ability of a state to enact legislation to allow presumed consent?

Emily Marcus-Levine said that there is no federal bar. There are some cases where the family is deemed to have a property right in the body. There may need to be a legal process to deal with that, but there is a need to protect constitutional rights.

Ronn Wade said that, according to common law, the primary right of disposition belongs to the next of kin. The only way that the family right can be overcome is through a will. The other way around it is eminent domain — the right of the state. This approach was tried in Pennsylvania and also failed in Maryland. There was a view that the state would be trespassing over the family rights.

Susan Gunderson asked if we are talking about organs, tissue, research, body parts. We need a long timeline.

Agrawal said that we need to present some questions before the full committee. We are not making a specific proposal. We need to generate the information we need so we have information to work with. This is a process.

Nancy Ascher said that we may be suggesting two demonstration projects that are in opposition to each other. Kahan said that once you offer an incentive to one group, it changes the other group's attitude toward purely altruistic donation. The last time the National Kidney Foundation discussed this, it was thought that those who were disadvantaged may be less likely to opt out. To meet constitutional challenges, it would have to be clear that there are surefire ways to record opt-outs.

Someone else raised the freedom of religion issue. Even though no major religion objects to organ donation, constitutional issues remain.

One participant suggested using the word "tacit" instead of "presumed." Perhaps attach the language "to save a life." Gimbel's research showed that 19 countries have presumed consent, but several do not enforce it. Can we talk to some doctors from those countries to see what the barrier is?

Kahan mentioned a recent article by Islamic scholars that emphasize the role of organ donation in saving lives. Not all countries enforce the donor's wishes over the family's because of public concerns, the possibility of improper notification, and so forth. Someone else mentioned the example of Singapore and events that occurred after presumed consent was enacted there.

Three years' lead time would probably be a good interval to allow for public education before enforcing presumed consent.

Roger Evans said that we are working with outdated information. Many people now know someone who has had a transplant. Attitudes may have changed.

Ronn Wade discussed an attempt to get the Maryland General Assembly to pass something. Eye banks may take tissue from any medical examiner cases. One particular group is those who are on life support. He mentioned required request laws.

Ascher suggested asking ACOT to endorse a proposal for developing a template for presumed consent. Then, as part of that, actually make contact with state representatives to see where we could get a groundswell of interest and support.

Kahan suggested surveying other countries to see why this concept didn't hold and see if we can avoid their problems.

Berry suggested this terminology: "Presumed consent: A way to save lives." He recommended sticking with the phrase "presumed consent" because it is embedded in the literature now.

Mary Ganikos said that the survey DOT is preparing will probably go out in 4 months. It is in the OMB pipeline. It includes questions on organ donation and presumed consent. Some items will be duplicated from the old 1993 survey so we can track those indicators. There may be a question to see if there is a difference between organs and tissues. The draft survey had been sent to the committee some time ago.

Valuable Consideration—Preferred Status

Josh McGowan presented some information from the SRTR data report related to preferred status granted to living organ donors. He reminded the group that NOTA prohibits the exchange of valuable consideration in connection with organ procurement or transplantation.

The goal of the data analysis was to quantify the impact of previous (living kidney) donation on waiting time for transplant candidates relative to cohorts in similar time periods and locations.

The analysis included all waitlist registrations for a deceased donor, kidney-alone transplant between 1/1/1993 and 12/31/2002. Waitlist registrants in this study cohort were stratified (grouped) according to previous living donor status. In order to determine a candidate's status, SRTR screened patients that were identified as being a previous living donor in the SRTR kidney candidate data file. They also investigated whether or not four waiting-time points were awarded during an attempt to match a candidate with an available organ as stated in the OPTN Deceased Donor Kidney Allocation Rule. Because not all candidates that were identified as previous living donors were awarded waiting time points, they separated "potential" previous living donor waitlist registrations into two separate groups as shown in Table 1.

Table 1: Previous Donation Status Among Deceased Donor Kidney Waitlist Registrants, 1993-2002 (n=197,137)

For all waitlist registrations identified in this analysis, a Cox Proportional Hazards model was used to estimate the time until 50% of all registrations received a transplant (median time to transplant). The model was adjusted for the following candidate factors: blood type, age, gender, race, type of insurance, peak PRA (indicates level of sensitization to donor antigens), status as a previous transplant recipient, waitlist year and location (Donor Service Area [DSA]; previously referred to as OPO). Waiting time was calculated as the number of days after waitlist registration until removal from the waitlist. Reasons for removal include recovery from illness, receiving a transplant, transferring to another center or dying while on the waitlist.

The results in Table 2 show that the median time to transplant for waitlist registrations that were identified as having previous living donor status and awarded four waiting time points was estimated to be 499 days (1.37 years; adjusted). However, for registrations not identified as having previous living donor status, the median time to transplant was estimated to be 1,115 days (3.05 years; adjusted).

Table 2: Meridan Time to Transplant (Adjusted)* Among Waitlist Registrants of a Deceased Donor Kidney-Alone Transplant, 1993-2002

The potential benefit of a shorter time to transplant may vary for candidates according to geographic region (DSA). As indicated in Table 3, 28 DSAs had an estimated median time to transplant of less than 886 days (2.43 years; adjusted) during the study period. However, there was a difference of 731 days in median time to transplant (2.00 years; adjusted) for the 28 DSAs between the 25th and 75th percentiles.

Table 3: Variability in Median Time to Transplant (Adjusted)* by Geography Among 59 DSAs, 1993-2002

McGowan noted that some 40 patients were noted as being living donors but had not received the four-point preference. He was not sure why that happened.

He concluded by saying that the median time to transplant for waitlist registrations with previous living donor status (1993-2002) was estimated to be 499 days (1.37 years) compared to a median time of 1,115 days (3.05 years) for registrations that were not a previous living donor. Therefore, 50% of previous living donor registrants were transplanted in an estimated 616 fewer days (1.69 years). However, the absolute value of the waiting time reduction is likely to vary substantially by where (geographically) the candidate is registered on a transplant waiting list (DSA). Median times to transplant during this period varied more than eightfold between the 5th and 95th percentile of DSAs.

It appears, then, that a waiting time advantage has been provided to kidney transplant candidates who are awarded four points for being a previous living donor. He also noted that the allocation rule was recently modified to provide a greater advantage by giving candidates who are awarded four points top local priority for kidneys that are not shared as a 0-HLA mismatch.

Kahan said that his impression is that the four points is not conferring a very great benefit. Living donors should perhaps be awarded six or eight points. The benefit could be extended to family members on a one-time basis. Merion said that four points does not mean a great deal in many areas. Kahan asked if it would be possible to give them more points. Merion said that such an approach is basically planned obsolescence. The aim of the OPTN board was to give them ultimate priority after children, 0-HLA mismatch, and presensitized individuals. How often are they preempted? Kahan said that if we are talking valuable consideration without involving money, maybe we should give preference on waitlist to the family. Emily Marcus Levine said that such a system would raise ethical questions because it could be coercive for those considering donating loved ones' organs. Also, counsel has not issued an opinion about the four points given for living donation. We do not want the Secretary to be pursuing an illegal course.

Jim Burdick said that Levine's point has not been addressed. We don't know that the points are valuable consideration. How do the points work? It is complicated. They are getting four years' waiting time credit. They may be using their points to stay on the waitlist and avoid using extended-criteria donor (ECD) organs and so forth. Kahan said that the system should work for all living donors, no matter which DSA they are in.

Ascher agreed that the amount of advantage is small in some areas. It is not enough. Sometimes they will be waiting more than 2 years. The value of four points decreases every year as the waitlist grows.

Most agreed that it would be too complicated to award preference points to family members of deceased donors. Families are complicated entities, there is a possibility of coercion, plus there is the difficulty of making this offer to a grieving family. Most agreed, however, that if you are a living donor, there should be some preference given that will allow a transplant to occur within 2 years. Implementation would be up to OPTN.

It was decided that SRTR should present their data to the plenary session.

An Alternative Preference System

Mark Nadel discussed an idea to increase the supply of donated organs by adopting "a policy of reciprocity, a kind of organ insurance."¹³ Those who committed to donate their organs in advance of their death should be rewarded with a small preference in the event that they need a transplant. This reciprocity model would serve as an incentive for people to donate. Such proposals have been the topic of a dozen or more medicolegal articles. The 1993 UNOS report gave it a mixed review, recommending future discussions. Nevertheless, this idea was ignored in the 1993 Government Accounting Office (GAO) report on organ donation and in the 1999 and 2003 House committee hearings on how to increase donations. He said that this idea differs from Lederberg's proposal or the Lifesharers' club-type preferences, which give too little weight to medical considerations. It is more akin to a local preference by which you receive preference within your status group. You cannot go ahead of somebody in a higher-status group. Where there are no status groups, give points (2 or 3) where there is not a status system (MELD).

The marketing campaign could be framed with an aversion to harm message, which makes people more likely to act. Appeal to the most disadvantaged by including a "John Q" provision.

Two benefits are envisioned: Such a system would make it in the medical self-interest of an individual to donate. Doctors would be more inclined to leave forms in their waiting rooms. People could sign up at the DMV. He noted that under the present system, a potential donor's wishes are not always honored by families. Here, you can say to the family, "Look, he opted in, so now it is time for him to meet his promise. He died before he could get the benefit offered by this program."

Nadel listed several objections that might be raised and offered some arguments in support of his proposal:

• There are no empirical data that it would work. Nadel said this is true, but we should test it.
• This approach corrupts pure altruism. Nadel said that this approach is reciprocal altruism. You can save many lives a year.
• Introduces a non-medical factor in the donation process. Nadel said that right now half of organs are wasted because they are buried. This system is better than "local first." Data show that people don't really focus on that. This approach would increase donations because people would perceive that they get something back.
• Some religions might oppose this system. Nadel asserted that religions that opposed donation are probably against transplantation.
• Uninformed people who did not register would now face another obstacle to transplantation. Nadel said that harm to the uninformed is no greater than from "time on waiting list."

He further proposed that each OPO dedicate some funds annually to underwrite at least one transplant per year for someone who otherwise could not afford a transplant.

Kahan asked about how such a system would handle someone who is already sick. Nadel replied that there would be a phase-in so that those who have been members longer would have preference.

Burdick mentioned a white paper that was written some years ago. Ethicists have a problem with deeming one person worthier than another. The view has been to see this scarce resource as a national resource given solely on the basis of need.

Kahan asked about what it would take to assemble this registry. Nadel replied that donor registration databases already exist in some states.

Ascher asked about how a demonstration project could be conducted. Nadel said that it could be tried in a state or an OPO. Test willingness to donate in areas where the program is marketed.

Levine asked what would happen if someone changed their mind. Nadel said he hadn't really thought this through, but the decision should be reversible albeit with some small fine or other penalty. He said that the system would also have to address the possibility of fraud.

Merion said that in regard to the 26-odd states that have developed donor registries: It is a registry of intent, not consent. The registry includes many minors because it is promoted through schools and so forth. Nadel said that parents could register their children.

It was suggested by the Subcommittee that Nadel present his proposal during the public comment period.

Valuable Consideration

There was some discussion about the original language in Frist's bill regarding paired exchanges.

Kahan asked about which entity will determine what constitutes valuable consideration. Agrawal responded that the question about the scope of valuable consideration may be answered through a lawsuit. The court then has the question before it, and the court will interpret the law. The other way is that the Department of Justice decides to prosecute some questionable behavior. There are states that have "copycat" legislation so it could come up in state courts. Typically, this type of issue would be interpreted by a court. Kahan asked who would guide ACOT about what constitutes valuable consideration. Agrawal said that the statute does not give authority to the Secretary to define valuable consideration. Levine suggested that ACOT figure out an approach and try it instead of going first to the Department of Justice.

Agrawal said that the Secretary could be given regulatory authority to define valuable consideration in this context. Another way would be an advisory opinion process. Both of these models have been used for Medicare-type issues. Levine noted that a strong ACOT endorsement may stimulate Congressional action.

Agrwal suggested bringing the issue to ACOT and then go back to the Subcommittee to work further to develop a recommendation to bring to the November meeting. Burdick observed that the time would be short for taking action. We need to address specific, practical details for demonstration projects, in particular. He raised the potential problem of boundaries issues by asking the group to consider the scenario of two deceased donors in two different states. What would happen if and when family members note the differences in valuable consideration?

Agrawal asked if it would be possible to have a demonstration project across state lines to test some sort of incentive. Burdick said that usually demonstration projects compare one action against another. Gunderson noted that we already have inconsistencies from state to state about using DCD donors, definition of brain death, and so forth.

Report and Recommendations of the Valuable Consideration Subcommittee (Subcommittee A)

Gail Agrawal

Kress reiterated that up until this time ACOT always has issued consensus recommendations, but we may be diverging from that tradition now. The votes we will take today signify direction to the subcommittees as to what they should work on between now and November. If we have a supermajority against a proposal, we will not proceed on that item. If there is enough interest on an item, however, we can invite a speaker on the topic and flesh it out for November.

Valuable Consideration

Kress introduced Gail Agrawal, saying that the Valuable Consideration Subcommittee is considering some alternatives to the purely altruistic system that we now have. Agrawal presented a discussion draft prepared by the Valuable Consideration subcommittee. Her plan was to set the stage to facilitate a discussion to see if we can systematically identify some questions that we must address in order to move forward on valuable consideration.

The NOTA prohibition on valuable consideration is a criminal statute. The overarching question is whether and what change or clarification we might recommend in respect to this notion of valuable consideration.

When lawyers say "valuable consideration," it means something specific. It does not simply mean money, as many lay persons think. In the general common law it refers to "anything having worth, whether monetary or intrinsic, which induces or motivates an agreement or a contract. Under this definition, any incentive designed to motivate an anatomic gift, not merely those with direct monetary value, would constitute valuable consideration." Valuable consideration is not just "dollars and diamonds." NOTA uses the term "valuable consideration" but does not define it. No court has issued a definition in the context of NOTA. This section of the Act does list some specific exclusions that allow payment for donor expenses and so forth. UNOS counsel has opined that the valuable consideration prohibition is meant to prohibit monetary consideration (dollars and dimes). This opinion is not binding on anyone, however, and certainly not on the judiciary.

There is a disconnect between the common law definition and how we in the transplant community think about valuable consideration. There are some consequences resulting from this lack of clarity:

• Uncertainty about legal consequences could deter transplant centers and OPOs from engaging in beneficial practices aimed at increasing organ donation
• Uncertainty about federal preemption of state law could deter state legislative action to create incentives intended to increase organ donation
• Risk of criminal prosecution for innovative programs that provide incentives to increase donation
• Federal preemption of state laws that create incentives to enhance donation on the grounds that the state law conflicts with the federal prohibition
• Loss of potential donors.

In its breakout session, this subcommittee talked about giving preference points to families who had consented to donation. Would that be valuable consideration? We don't know the answer.

Agrawal posed several questions to the assembled group:

Should ACOT recommend to the Secretary that he seek to have the meaning of "valuable consideration" and the scope of the prohibition clarified? The participants concurred that this question should be pursued for both living and deceased donors. Should we continue work on the question? Williams specified that the deceased donor category should included donors deceased after cardiac death (DCD).

If ACOT concludes that the term "valuable consideration" should be clarified, how should the clarification occur? Agrawal offered several options for the group to consider:

• Amend NOTA to include a definition of valuable consideration. If a definition were included, how should it differ from the common law definition?
• Amend NOTA to specify additional exclusions from the prohibition on valuable consideration. If exclusions are added, what incentives or practices should be excluded?
• Amend NOTA to authorize the Secretary to promulgate regulations, subject to the notice and comment period prescribed by federal law, to define the term and/or describe practices or incentives that will not be deemed to constitute valuable consideration for the purposes of NOTA. If the Secretary were to seek such authority, should its exercise be subject to specified limitations or guidelines?

Harmon suggested that we should just make the recommendation without going into detail about how the change should be made. The reality is that the statute is where to address it. Agrawal said that there are other ways that may be easier. Also, if a center wants to try some incentive program, we could seek an advisory opinion from the Department of Justice. Our choice of approach does have some consequences.

Going through the legislative process will be laborious and slow. We have a supportive Secretary. We should act now. Kress said that whatever we do in this area will entail a legislative process. If we list in the legislation exactly whatever is permissible, then anytime we want to make a change it is already graven in stone. The second approach is more flexible, but a different Secretary could take a different approach.

Kahan asked why the language permitting demonstration projects was stricken from Frist's bill. Delmonico said that Frist had to deal with clear opposition to living donors receiving money. Demonstration projects might have been seen as a slippery slope that would lead to payments to living donors. The demonstration projects were not defined. Congress was not willing to discharge that responsibility to whomever might be Secretary at the time. If the nature of the demonstration projects had been defined, the language might have been left in. Kress said that he has heard various speculations, but we cannot really know Congressional intent, especially on a negative, i.e., on why a provision was left out, since any statute involves so much compromise.

Delmonico said that the lack of a definition leaves paired exchanges in limbo. Congress knew that paired exchanges were already underway. They chose by their silence to affirm the 1984 NOTA. Agrawal said that seems a stretch because the sentence about familial, emotional bonds, and so forth was also struck.

Agrawal asked if everyone agreed that the term "valuable consideration" should be restricted to meaning money or a monetary equivalent given in the context of organ procurement, donation, and so forth? Delmonico used the term monetary enrichment.

Michael Williams said that NOTA was written 20 years ago, and we need to shine a light on it. The world of transplantation has changed. We want to avoid the situation that someone is induced to take a risk that they would not normally take or that someone who is disadvantaged would be induced to do so. Agrawal said that such language adds another level that reflects the strength of the inducement. Harmon asserted that it is abhorrent to buy or sell organs. Paired exchanges are not enriching anyone. Ascher suggested that we should consider valuable consideration to be monetary enrichment. We already have safeguards in place to make sure that people don't take unacceptable risks.

Levine stated that living donor expenses are not prohibited. They are expressly excluded from the prohibition against valuable consideration. Agrawal said that the question of who is going to pay is still open even if payments are legal.

Kress said that it is common practice in law school to use hypothetical examples as a learning device to test our concepts, and he proposed one such hypothetical example. We have heard about situations with living donors where it is suspected that a gift or something has been given to induce them to donate. If it is discovered that a family has given something of value to someone in the family as an inducement, should that, hypothetically, be regarded as a criminal violation? Agrawal said that it is a criminal violation. There is no reporting obligation, though. Kahan said that often, when he deals with families, he will see that the donor has a new car or is going to college 3 or 6 months later. It happens. It is just part of the interaction. No program is clean of that. Ascher cautioned that if the transplant team knows about it ahead of time, the donation should not occur. It is a duty to see if there is hesitation or uneasiness on the part of the donor. Williams said that the difference is whether it is given or promised ahead of time as an inducement or if it is given afterward as an expression of appreciation.

Turrisi asked if there is a way for CMS to issue an opinion or something to say that lost wages, out of pocket living expenses, and so forth are reimbursable expenses. Once that happens, insurance companies usually follow suit. It is analogous to organ procurement expenses. That is the crux of the matter. There is a disincentive for people to become living donors. Roger Evans noted that there is a process by which CMS makes decisions about reimbursements. We should recommend that CMS make a coverage decision regarding expenses for living donors.

Solarz posed another hypothetical: Under this framework, would a flat fee paid to all living donors be legal as compared to reimbursing actual expenses? If you pay the same flat fee to all living donors, are you in fact paying for the organ for those who have lower actual expenses? That is problematic. It seems murkier in a legal framework.

Diana Lugo-Zenner observed that states could do something similar to what Wisconsin did ($10,000 tax credit/deduction). Turrisi said that she does not believe that CMS will give us a reading because we lack a definition for valuable consideration. Turrisi said that we need to hear from CMS that it will reimburse the costs associated with living donors.

Agrawal returned to the question of demonstration projects. Ascher said it is important to work under the Secretary's guidance to embark on a series of demonstration projects. We must clearly define the parameters of any demonstration projects. She does not envision any arm of a demonstration project to include monetary enrichment. Agrawal asked about what kind of limits we would want to set. The participants suggested:

1. No monetary enrichment.
2. An ethical analysis of any proposed demonstration projects. One component must address the inducement/appreciation aspects.
3. Research component to look at the same people who are contributing to the research project having access to transplantation. For example, if, as a result of a demonstration project, suddenly many more minorities donate, we need to ensure that those people would get access to transplant.

Agrawal then went through the tabular summary of valuable consideration options (prepared by Roger Evans and attached as Appendix A). The purpose of the voting on these actions was solely to give direction to the Subcommittee as to which items it should pursue further, and flesh out in further detail at the November meeting, and was not to be regarded as a vote for or against the outlined proposal itself.

Appendix A. Tabular Summary of Valuable Consideration Options

Most, if not all, agreed that the first six options were acceptable. The results of further voting are recorded below.

• Item 7: Funeral expenses are certainly an inducement to financially disadvantaged families. Agrawal said that paying for funeral expenses would likely constitute monetary enrichment because it is a foregone expense that the family would have to pay. Reimbursement of funeral expenses would be an ideal demonstration project. Kahan noted that this option was on the books in Pennsylvania but was never initiated because a concern about its legality under NOTA. The vote indicated that this item should remain under consideration by the Subcommittee.
• Item 8: Tax deduction/credit. Solarz said that this option is financial enrichment. Kahan said he would not support this option. Four voted to keep this under consideration restated as a state tax advantage of some sort. Eight voted against.
• Item 9 (refundable credit): This item was not well understood and was not discussed at any length. Five people voted to keep this on the Subcommittee's agenda, and eight (or more) voted against.
• Item 10 (life insurance policy to be received by a person or organization designated by the donor following successful deceased donation): Nine people voted to keep this on the agenda; four voted against.
• Item 11 (guaranteed lifetime health insurance for living donors): Solarz mentioned having some mandatory, minimal insurance criteria that would say that companies must insure for this. Carlton Young suggested that such a program might help keep living donors in follow up for the registry. The National Marrow Donor program may already be providing life insurance, so there is some precedent. Nine voted to keep this on the agenda; four voted against.
• Item 12 (bonuses paid to individuals and organizations involved in organ procurement): Kahan said that we cannot just dismiss bonuses; they have been part of the reason for Spain's success. There was some discussion about whether some OPOs are already paying bonuses to their coordinators. Bob Merion said that his OPO checked to see if other OPOs were compensating or giving bonuses. It appears that some were giving bonuses for exceeding a certain number of donors per year and so forth. Sollinger said that such bonuses could totally destroy public perception and send us back to the ice age. They are improper and would also be a disaster from a public relations standpoint. Sollinger said, however, that we definitely need to discuss this topic, especially if it is already happening. We need to learn something about this. Seven voted to keep this before the Subcommittee; seven voted against.
• Item 13 (living donor/deceased donor exchanges): Most agreed that this is already happening. Giving a live donation to help a loved one move up the cadaveric list is a real motivator. There is no financial enrichment. Fourteen voted to keep this on the agenda; zero voted against.
• Item 14 (direct cash payment): not acceptable to the group. Four voted to keep this on the agenda; ten voted against.

Son-Ja Jones spoke about how frustrated she feels that the group is just now trying to figure out how to use incentives to get more organs. Just now you are starting to share about what works and what doesn't. Most of the proposals just help compensate for what the donor goes through and the risk they are taking.

Agrawal said that perhaps the group should talk about proposals that would be implemented if there is some adverse consequence to the living donor.

Bob Merion addressed the impact of previous living donation on waiting time for a subsequent deceased kidney donor transplant. He presented SRTR's data on the topic. A very recent change places prior donors "at top priority," following zero-HLA mismatched organs. The benefit of the extra points is not the same in all parts of the country. In a low-wait-time DSA, the value of 4 points is significant. There is far less real benefit to those in high-wait-time DSAs.

Kahan opined that this is not enough of a reward for this group of patients. Might we just give them more points so they move way up? Merion said that it would be possible to just increase the number of points so that living donors would be way above the median time for every OPO, say, 100 points. Eight or ten points would not be enough in a couple of years to give living donors much of an advantage because of the increasing length of the waitlist. Nevertheless, if we just award points, they would still be preempted by zero mismatch and pediatric time-expired candidates.

Presumed Consent

Phil Berry presented some information on the presumed consent question. He referred to an article entitled, "Do Defaults Save Lives?"¹⁴ He said that the general population will take the path of least resistance. This study gives a glimmer of hope for considering an opt-out system. The Valuable Consideration Subcommittee discussed the pros and cons of presumed consent. Until we consider this option, we do not know what will work. We are losing the battle. It behooves us to consider every option.

This Subcommittee would like to see ACOT validate the consideration of presumed consent as one other option to boost donation. We would like to develop a template for a demonstration study. We know that a Gallup poll will be coming out in the next 4–6 months so we can look at what the American public thinks about presumed consent. Four questions on the survey deal with presumed consent. After this survey, we will have some data on which to base our actions on this topic. Where do we proceed after today?

He posed a series of questions to the group. Again, the purpose of the voting on these actions was solely to give direction to the Subcommittee as to which items it should pursue further, and flesh out in further detail at the November meeting, and was not to be regarded as a vote for or against the outlined proposal itself:

1. Should ACOT recommend to the Secretary that an opt-out system based on a model of presumed consent be explored as a method to increase the number of organs procured from deceased donors? Thirteen voted for taking this action; one voted against. Solarz cautioned that an opt-out system will never get off the ground. Be careful about making statements about supply and demand because it is different for each organ. Bob Higgins suggested that we need to do better in terms of organ utilization. Kahan said that we could face public opposition. If the survey results indicate that this is not going to be accepted, then we should abandon it. Sollinger said that presumed consent could be an important trigger to get more organ donation. What would be needed to start a demonstration project? Kress said that it would take legislation to change it. Levine said that consent laws are handled by the states, so a state could change its law. Ganikos predicted that the results of the poll should be available in mid- to late October. Delmonico said that the American Civil Liberties Union in his area imposed upon the state legislature not to move forward. We will need something to overcome that opposition. Ascher said that in 1984 the majority of people supported organ donation in a Gallup poll, but conversion rates were 30%. There is a disconnect. We need to see what works through demonstration projects. Harmon said that in this country, the individual is more important than the state. We should do the demonstration projects and then decide which way to go. The demonstration project would show us if people act as they say they will.
2. If ACOT concludes that a model of presumed consent should be explored, what form should that exploration take? Most supported the notion of demonstration projects (13 for, 1 abstention). It may be premature to move toward federal legislative initiatives to encourage state action. If a state approach were implemented, there would have to be a state registry. There would have to be a public awareness program. It would be tailored to the state. Young asked if we might end up with a patchwork quilt? The answer is yes, each state could have a different approach.
3. If ACOT concludes that presumed consent should be explored, should ACOT recommend a specific presumed consent model? The majority (6 for, 2 against) thought that the Subcommittee should deal with both pure and modified presumed consent.
4. If presumed consent were explored, a method of opt-out would be required. Should ACOT advise the Secretary about the characteristics of an opt-out system? Twelve voted in favor of advising the Secretary on this topic.

ACOT Fair Treatment Subcommittee (B)
Breakout Session

Members:

William Harmon, chair
Nancy Ascher
Robert Gibbons
Amadeo Marcos
Son-Ja Robet Jones
Flora Solarz
Kathy Turrisi
Mike Williams
Carlton Young
Hui Hsing Wong
Hans Sollinger

Other participants: Deborah Shelton (a reporter from the St. Louis Post Dispatch), Alan Leichtman (SRTR), and others.

William Harmon welcomed the group and described the process. The Fair Treatment Subcommittee will be expected to define the scope of the problem and generate recommendations. The group will also hold two conference calls later on: The first will be used to make progress reports and the second to make actual recommendations. Harmon expects each of the seven subgroups to have its recommendations ready to present for the second call. Clearly, most of the work of the committee will be conducted after this meeting and will be summed up during the conference calls.

There are seven specific areas to be discussed, and the Subcommittee will generate recommendations around each of these areas (see below). Each subcommittee member is on at least two of the seven committees. The process for the breakout session will be to have one set of committees meet to talk among themselves, define areas of interest, and then report back on future activities and responsibilities. Then, the second set of committees will meet and go through the same process. Dr. Harmon noted also that the SRTR is present and encouraged the members to think about specific questions to ask.

First Set of Subgroups:

Nondirected Donors — Harmon, Young

Harmon described the issues discussed in this subgroup.

Two types of donors — First, there is the pure, directed, straightforward person who comes and wants to give an organ. Second, there are swaps in which there is a living donor and a deceased donor swap. In this situation, there is a net increase of one on the list. Our sense is that it's the responsibility of the hospital where the donation will occur to do the donor work-up. If the hospital where you're doing the transplant has different criteria, it's up to them, not the facility where the work-up started. In other words, you don't have to do a new work-up, but you can. You can't force a donor on a hospital.

• Recommendation: have the hospital where the transplant occurs do the donor work-up.
• Recommendation: Do not force donors on a hospital.

Choice of hospital — The choice of hospital should be up to the donor. If the donor goes to Mass General and they say the donation is fine, it's not okay to tell the donor they have to go somewhere else. Unless it's a living donor swap, you can't tell the donor that they have to go somewhere else.

Williams — This doesn't work for those who are underprivileged, though.

Harmon — We're talking about the donor.

Williams — If there is only one place to donate locally, but they know it would be better to go to Illinois, what if they can't get there?

Harmon — It's just that we have to say that the donor gets to choose. They get to decide — this will get into allocation later. As a principle, you should not push a donor anywhere except when it's a living donor swap.

• Recommendation: Donor should be allowed to choose the hospital where the donation will occur.

Allocation: If someone comes in to donate, should that organ be allocated in the hospital, the state, the region, or the United States as a whole? How do you allocate?

Solarz — There's a medical reason for having the organs be given to the local people. It's true for liver, it's probably true for kidneys too.

Harmon — In Region 1, the allocation is by hospital, not region. It's like that also in Minnesota. In DC, however, they allocate within four hospitals: they are doing it by consortium. Our view is that it should be allocated by the donor hospital, not on a wider basis, unless the local group feels they can share without losing quality. Our scheme is hospital first, not OPO first, as UNOS is.

• Recommendation: Allocate organs with in the local donor hospital first, unless the local community has selected another system (e.g., consortium-based).
• Recommendation: Select recipient based on UNOS run of the local hospital's lists (except for children).

Solarz — Would they be able to pick any patients?

Harmon — Then, we recommend that it's done by UNOS run in that hospital, down to 5 patients. Practically speaking, people take the best recipient rather than going down the list. We're saying, use the regular list — but not for children, though.

Turrisi — We always direct to child first, then go down the list after that.

Harmon — That's okay, that's how you structure your list. This is for kidneys. You use your regular UNOS allocation and that may involve always having a child at the top of the list. For nondirected donors, we had said you can't choose a class or category — for example, "only" donate to firemen, African Americans, Yankee fans. You can say donate to a PERSON, but not a class. We had a discussion at the last meeting about children. We decided to say no, you can't say the donation should go to children specifically, and I was the one leading that debate. I said it because it was a slippery slope and they should go to a pediatric hospital if they wanted to go to a child. But, it turns out there aren't very many pediatric hospitals that are appropriate. We are looking at the data now. So, do we want to allow them to say directed to children as a class? It would be the one exception.

• Recommendation: Reexamine the issue of prioritizing children as a class of recipients; create recommendation for prioritizing children.

Wong — Allocation allows kids to move to top of list anyway, so it's not that different. They get offered marginal organs and it clogs up the system, so this system would help with that problem.

Sollinger — There is universal sentiment all over the world: people will do for kids what they won't do for adults.

Harmon — We'll work on the pediatrics issue and develop a rationale for kids being a special group.

Solarz — If you have a 60-year-old donor you don't have to offer it, and they don't have to accept it.

Leichtman — In terms of choosing the recipient, the issue is to follow objective criteria — like a matched run — in which you have an order of patients, and then the patient from that list could come from donor preference. As long as you offer the donation in the order of the matched run, it's okay. We had a woman who requested that we find a sensitized patient and we did that.

Harmon — That's a slippery slope.

Williams — We need to describe the choice to give to a child as legitimate discrimination, while other forms of choice are not legitimate. What if they say, don't give it to a child. Then what? We have to look at the alternative.

Evaluation — no changes.

Follow up — no changes

Quality of Life — Williams, Turrisi, Jones, Solarz

Williams — This is in the context of the Burden of Disease presentation, and with the note that none of us is a statistician or a quality of life (QOL) person. But, two of us have received transplants. Our group went to fundamental questions. We're looking for the basics.

So, the first question is should we use QOL to look at outcomes in transplantation? The answer is yes.

• Recommendation: Use QOL to examine outcomes in transplantation.

The next question is, what do we measure for QOL? In terms of measurements, Flora has identified six things, and there are many more ideas of what to look at. The debate has been about biological markers (patient and graft survival), but QOL is psychosocial, economic, about the family, the caregiver burden, etc.

• Recommendation: Incorporate nonbiological markers in assessing QOL (e.g., psychosocial, economic, family, caregiver).

The next question is: What tools do we use to measure? Not much has occurred in this realm to date, but maybe we don't know the literature. Then, what is the validity of the tools? Do they have face validity?

• Recommendation: Explore validity of tools used to measure QOL.
• Recommendation: Develop transplant-specific QOL measures.

Finally, we have to ask for what purpose do we collect the data? Is it for the individual, for the physician, transplant center, OPO, OPTN? It ranges from the individual to an organizational approach. There are many purposes for gathering data — for policy, prognosis, prediction, persuasion (e.g., using QOL data to persuade people through informed consent to either have or not have transplant).

This group has to ask HHS to begin to incorporate QOL into organ transplantation issues. We've had calls for research on this — using existing data sets on SF-36, data on the QOL arena in medicine (especially in terms of diseases that may result from transplantation).

• Recommendation: Ask HHS to incorporate QOL into organ transplant issues.

Are these tools valid for transplant patients? Then we can develop transplant-specific tools.

Lastly, we can learn from MELD/PELD: If we will use the data to drive policy, then we should have a model about who is affected (e.g., patients, OPOs) and evaluate the predictions.

• Recommendation: Generate a model that explores who is affected by QOL issues.

Turrisi — Some people have tools (e.g., Vanderbilt). I know Larry wants to do studies with particular tools. My issue is that I don't feel the data are reflective of QOL issues. I don't think that we are looking at all of the tools and what should be asked.

Solarz — There are many questions. Do your transplant outcomes match your expectations? If not, have you been able to adjust? What are the measures of regret and satisfaction? What are the measures of interactions with the provider? What is the financial burden, the family dynamics? We don't ask these things on the SF-36, but they are important. It's beyond "do you feel well and can you function", it's "are you satisfied with your life?" There is something missing in the scale.

Wong — That's not what's intended in the study. Some of these are center-specific things to put in the model. You have to be careful about asking validated questions. These are legitimate questions, but this is a research model for predicting burden of disease.

Turrisi — QOL is more than burden of disease. It includes factors that affect people in the long-term. We may think they're doing great, but they think they're doing horrible, for example.

Solarz — A lot of the elements are out there, but they have not been brought together.

Wong — You can bring it into the model, it can take a lot of data from different sources. Studies that have done this well exist, and they can be added in. You are assuming that the SF-36 is the only measure being used, but it's only one among many. They are asking other questions.

Turrisi — Larry Hunsicker didn't show us that, though.

Harmon — So, should allocation be based on outcome? This is the real question. Should we allocate to those who are going to do best, for example, to a 20 year old vs. a 70 year old? Is it time for the OPTN to look at outcomes and develop an allocation based on outcome?

Young — The problem is that we don't know enough about the factors that go into it. African Americans (especially men) wouldn't get any transplants if we just look at outcome measures. Small, Asian women do the best because of size, genetic differences, etc. They have less trouble with rejection, better survival rates. You would exclude a big population of people who would otherwise get treatment if you just look at outcomes. It gets into rationing.

Williams — There is a lag between the evidence and where we want to be. If you want to use objective, valid measures to predict who will do best — then you have to incorporate ways to improve those measures for people who don't currently have good measures, so they can get there.

Sollinger — I am 100% with Young; making criteria to exclude groups is a problem.

Turrisi — In terms of outcomes when you look at graft survival if you just look at it, yes. But you have to look at other things for QOL.

Harmon — We have to have a reasonable basis for making a recommendation.

Minimal Listing — Marcos, Gibbons, Sollinger, Wong

Gibbons presented the group's report. There are two proposals by UNOS: one is for minimal listing criteria in which a person with a MELD score of less than 10 is not placed on the list. If you went on the list with a higher number and get reduced, you can stay on the list; also, if you were on the list with a lower score before the new rules went into effect, then you can stay on the list even with a lower score. Gibbons described one disadvantage of this approach as that there is an entire group who is out of the system: They start as a 9, later they become a 15, but they don't get followed up with and never make it onto the list.

Marcos — If someone comes in and doesn't meet the criteria, when can they be reassessed?

Harmon — It's unclear; they are not part of the system, and the routine system does not apply.

Gibbons — If MELD criteria are used, and someone gets a score below the minimum — would the provider hold onto them until they raise the score above 10?

Harmon — Some will, but there's no requirement to follow the patients.

Gibbons — In terms of the cons, now we have a new category that reminds us of the old status-level categories. There will be lots of petitions for exceptions: someone who has a MELD of 7, but has cancer, and so on. There will be lots of exceptions that will have to go to the review boards. Some of the regional review boards are good and some aren't.

Wong — The way it is now, if you are below 10 and want to go on the list, you have to go before the boards. Many people don't know their boards.

Gibbons — There are a lot of OPOs that are transplanting these patients; one-third of patients in many places have a score of less than 10. Some are instances of bad organs going into good people, where others have refused the organ before. Some are patients with exceptions.

Harmon — At a minimal offering, we are looking at a modified version of regional sharing.

• Recommendation: Explore adopting a modified version of regional sharing.

Wong — The way the system works, you offer the organ locally up to score of 15; if there is no local patient, you go regionally to patients up to a score of 15. If there is no patient regionally, you return to locally for lower-scoring people. What it means is that very few offers are made to patients with lower scores, unless it's an instance of a strange blood type or bad organ.

Gibbons — There are several issues. Broader sharing means there is no need for minimal listing criteria. It provides an allocation system based on a broader population, so there is a greater likelihood for getting organs. This gets around the need for minimal listing. But, it ends up being bad because the patient is lost to follow-up.

• Recommendation: Explore ways to retain patients for follow-up.

There is a caveat — the proposal for sharing is nested in identical blood types, which is strange. It should be for compatible blood types. If I have an O with a 14 and there's a patient with a MELD of 40 and a compatible blood type, the organ should go to them.

• Recommendation: Adopt a regional sharing process that is based on compatible blood types rather than identical blood types.

Wong — That's the current system, for liver it goes to blood type first.

Harmon — But O is universal, so O recipients are at a disadvantage and have to wait longer when the organs go to other patients.

Wong — If you don't have an O patient, but you have an A or B patient, you would go regionally for the O, rather than locally to the A or B.

Harmon — Is the O recipient disadvantaged in that circumstances? Where you use up the O livers on As and Bs. Can you do this?

Wong — We looked at it for observed waiting times.

SRTR — We could model a rule where an O is distributed to compatible blood types. We need to know how many people get transplanted and the impact on life.

Wong — The liver committee looked at O organs going to A and B blood types. It used to be done by adding a score of 20, but people got complaints and so they modeled the impact. We showed no impact on life if you use 20 or 30 extra points.

Harmon — Let's not copy UNOS's work; let's think outside the box.

• Recommendation: Study the impact of a regional sharing by compatible blood type model on O donors.

Sollinger — The liver is different because it's a loss of the graft and you can't salvage it unless you bring the next compatible person in. There's a huge time pressure. They have an hour to decide and by the time they decide, it's too late. We need to share more. I'm all for the MELD cutoff, but we need rules that do not lead to greater graft loss. If sharing leads to greater graft loss, it's a losing proposition.

Gibbons — An expanded list of donors should not be part of the program. Special cases should be at the discretion of the local OPO — they are the ones that aren't on first offer, they are the ones losing time.

Wong — There's no definition for expanded donor for livers. With kidneys, it's more clear.

Sollinger — What about "non-heart beating organs?"

Wong — Those are rare.

Harmon — No, it's 20% and growing. We have to talk about the future.

Gibbons — We started by looking at UNOS proposals: minimal and sharing. Our primary interest is that if they use these, then they don't require minimal listing if they have broader allocation. We need a careful study of the question of whether broader allocation follows blood type rules.

Solarz — It depends on your OPO. In New York, almost all of them are classified as extended criteria donor organs, we think. We have a long waiting list.

Gibbons — If they are all ECD, then that destroys the issue. We need a clear definition for ECD for liver as for others. We have a definition for extended donor.

Wong — UNOS is, for the first time, considering a form of broader allocation. We are looking at comments. Minimal listing stuff is getting creamed. We can make a statement one way or the other and we should do so. Minimal sharing gets you around the problems of minimal listing.

• Recommendation: Provide comments on UNOS consideration of minimal listing and broader allocation issues.

Sollinger — We need a better prediction of survivor. A list, not just MELD, needs to be created. We asked for that in the first meeting from the SRTR, so we could define the criteria. You need to model it and they're working on it.

• Recommendation: Create a list that helps predict survival (beyond MELD).

Special Needs of Pediatric Patients — Harmon, Wo

Harmon presented the group's report. In terms of background, there is a social history of providing preferences for children (e.g., education, not being forced to work). Children have always been looked upon differently, and so it's reasonable to have special cases for them. We will summarize OPTN methods for preferences for children for these things. We will write a background paper on kidney, liver, heart, and lung.

• Recommendation: Write a paper describing children's issues that addresses kidney, liver, heart, and lung and describes how children have been viewed separately as a class, OPTN methods for giving preference to children.

Allocation — We need a principle that children are special and that providing preference to them does not set a precedent for other groups. If we use the facts of children's special treatment in other instances, then this will set a substantial principle. Then, saying that a non-directed donor can contribute to a child because they are special group is all right. Most people will agree with this.

• Recommendation: Create a principle that children are a special class and may be provided preference without setting a precedent for other groups.

Children as donors (DD and LD) — We want a section on this. We need to note in the paper that there are a large number of children who have been deceased donors. In fact, they are more likely to be donors than recipients; and they are very ideal donors. We also want to discuss living donors. It's not controversial: children shouldn't be living donors. There are a few instances where it's reasonable (e.g. a 17-year-old mother who donates to her own infant). But, they should not be used for living donors for adults.

• Recommendation: Include, in the paper, an overview of children as living and deceased donors. Include federal regulations and other rules that apply to children.

Wong — Legally they are not emancipated, they can make medical decisions but they are not emancipated. Medical decisions are different. They can't sign contracts and engage in other decisions. It doesn't mean they have to pay their hospital bills. Laws on adulthood are different. The principle is that we don't think is appropriate unless there are special circumstances. With liver, it's a harder ethical decision.

Solarz — There are risks associated with liver donation and a value to the mother not putting herself at risk — in terms of her being there to rear her children, for example.

Wong — That's very legitimate. An ethics committee should review this when it's done.

• Recommendation: Have an ethics committee review the paper upon completion.
• Recommendation: Track and note how frequently child donations occur to explore the need for exceptions in regulations or a process for appealing to ethics committees.

Williams — We should track how often exceptions occur. We can define the need and see if we need exceptions in regulations or a process for appealing to the ethics committee.

Harmon — There was a recent study published on 40 or 50 teens. There were a fair number of kids donating to older adults, like a 13-year-old donating to a 54-year-old. We might need to have a principle that kids only donate to kids.

Clinical trials. There are rules on children from the feds. We should restate the rule and the principle. Reemphasize the issues and clarify them.

Transition to adulthood — After transplant, children transition to adulthood and this has not been looked at carefully. How much insurance do they have? Do they get their drugs? Plus, young adults don't have an advocacy community, and they are not getting kidney transplants.

• Recommendation: Explore issues of transition to adulthood for child organ recipients.

ECD Status Evaluation — Solarz, Turrisi, Marcos

Solarz — In terms of looking at ECD, the kidney is clear. We're looking at livers here. Approximately 80% of ECD livers are from non-heart-beating donors and cases where the only organ taken is the liver. The idea is to look at those and evaluate donors for primary nonfunction, to see if there is a threshold of what an ECD would look like. We want the SRTR to look at ECD livers. We didn't talk about hearts and ECD living donors.

• Recommendation: Examine threshold for ECD by exploring ECD liver donations to explore donors' primary nonfunction.

In terms of hearts, there are centers that might take more marginal donors if they were offered up. How do they get to say, yes, I want that heart? The question was about the donors who are aggressive and want to be donors, but they are pushing it.

Sollinger — They still call UNOS, and the center would say they want the heart.

Harmon — They have their circles that define when it's reasonable. They call within those geographic circles.

Turrisi — Are there centers that are interested in marginal donors and can't get them?

Harmon — "Marginal" is more a case of a 56-year-old heart versus a 55-year-old heart, that sort of thing. Waiting time has been decreasing; we're seeing success in the heart area. We need to retrieve more organs per donor. Another issue is that there are a number of potential heart donors who are referred early and may, due to management at end of life, have cardiac malfunction. It's a single time-point offer. Having crossed over and become brain dead, they might be able to be managed and resuscitated and could be able to be rehabilitated to be acceptable as a heart donor.

• Recommendation: Explore issue of brain dead donors who may be able to be resuscitated and rehabilitated as a heart donor.

SRTR — In terms of organs per donor: it puts the community in a schizophrenic position with competing goals. Is it to increase organs per donor? You wouldn't then go after ECD with two kidneys, or just a liver donor. It's a disincentive. I am troubled by goals that conflict. Having lower organs per donor would be ok if you had the same donors as last year, plus 14 extra livers.

Sollinger — There are huge costs for ECD donors. It has a long-term negative effect on organ donation.

Organ Refusals — Turrisi, Williams

Turrisi — Barry thought that there were problems in the payback system for kidneys because Maryland didn't get penalized. Others felt it was not true, the system was getting ready to change again and there may not be a problem. The system is intact.

The whole issue of organ refusals is connected to ECD and DCD organs. We have a system where we have marginal organs and it takes a long time to try to place them. A second issue is that we want a better system of marking organ refusals and why they occur. The UNOS change has refined the refusals better.

• Recommendation: Examine why organs are refused and when these situations occur.

The question is, what should we do on DCD and ECD organs and getting them through the system faster? Our recommendation is that the DCD and ECD should come off the shared list.

The recommendation is that there should be no obligation to share these, although you can do it if you want to. You have to get them in quickly, that's the key. There should be no mandatory offering.

• Recommendation: There should be no mandatory offering for liver and kidney DCD and ECD — they should come off the shared list.

Young — You mean, for all ECD?

Sollinger — No, for liver and kidney. The heart is not an issue; they don't do it. If they don't accept it, they don't retrieve the heart. It's said beforehand and, if nobody wants it, they don't even take it.

Turrisi — The issue is really about not having mandatory sharing of the organs.

Young — Can we ask the SRTR to stratify ECD kidneys in terms of risk factors to see how often they are shared?

• Recommendation: Ask the SRTR to stratify ECD kidneys in terms of risk factors to see how often they are shared.

Turrisi — People spend a lot of time trying to place organs. One of the issues is that there is no need to mandatory share in this sense, and then what do you do after that? How do you get to the system where you're still not calling? Centers don't want to be out of the loop — they might want it one day. It's an issue of timeliness.

Turrisi — There is another recommendation that the risk adjustment needs to be included in costs.

• Recommendation: Include risk adjustment in costs.

Unfairly Treated Groups — Young, Gibbons, Marcos, Jones

Young presented for this group. There are multiple issues:

Minority status — We want more updates on the impact the allocation scheme has had for minorities, and to analyze all minorities (in addition to African Americans) to see the impact. We will ask the SRTR to do this. The MAC committee is asking to look at heart and liver access to the waiting list. Data are hard to get, outside of kidneys. Liver and heart are harder to get and it takes more work. The MAC committee will give us the data to look at heart and liver.

• Recommendation: Ask the SRTR to provide updates on the impact the allocation scheme has had on minorities.
• Recommendation: Get data on liver and heart from the MAC Committee.

Women — There are access issues here too. Are women as a group experiencing decreased access to transplants — either getting on the list or when they are on the list? If that's the case, is it based on socioeconomic status, ethnicity? Where is the problem nested?

Harmon — What about women as living donors? This was raised as an issue in Amsterdam. Women are 60% or 70% of the donors. Women are preferred donors, and men are perceived recipients. We have the data, the issue is whether this is an interesting question?

• Recommendation: Explore issues of sex and access both in terms of getting on the list and getting organs once on the list.

Insurance — SRTR presented a study based on exploring insurance as a predictor and looking at whether, if you were on the list, you were getting an organ. African Americans are less likely to get a transplant based on their insurance status, even when they had Medicare. We want the SRTR to go back and rerun the data based on the new allocation system to see if the discrepancy still persists, and if so, why? If they have the same socioeconomic status, why is there a difference?

• Recommendation: Ask the SRTR to rerun data for the new allocation system to see whether discrepancies exist regardless of insurance status.

Wong — In terms of the OPO, the difference is not as large. But, access to the waiting list is the key issue. It's the first and biggest barrier. That's where you are going to find the most significant difference.

Turrisi — We don't have the numbers for that. African Americans are not referred in my state. When you get them referred they get on the list, but we're trying to get them referred in the first place. Medicare only patients who have to pay a co-pay and fundraise to get on the list. There are a lot of kidney patients who are Medicare only. There will be a bias against them, because the centers have to pick up the cost of the drugs.

Young — They did show that African Americans had less access to the waiting list and they had less access to transplantation when they were on the list.

Wong — SRTR found that the Medicare patients with private insurance are less likely to be referred. There is a difference between those who go onto the list, and then access off the list.

Williams — How will discount cards affect this? Immunosuppresant drugs are covered for three years. You might lose your coverage after three years.

Elderly — We want to go back and see how we are doing with older patients. Do co-morbidities increase risk? As the population ages, we have to look at this. Have we created a group of disadvantaged 18-34 year olds who are not getting organs? Has the pendulum shifted to older recipients and how has that harmed the younger patients? ECD also comes into play here.

• Recommendation: Assess how co-morbidities affect risk and the access younger people have to organs (i.e., 18-34 year olds).

Diabetics — Which ones are dying on the list? Are there healthy diabetics out there with a lower risk of death? Are there ones who are dying on the list when they aren't really eligible for transplant? They could be disadvantaged; then we have to address it. If they have a higher risk of death, we need to know that.

• Recommendation: Explore whether there is a class of diabetics on the list who are ineligible for transplant.

Sollinger — Do you think there is a substantial number of diabetics who are on the list who are not eligible for transplant?

Young — We don't know, but we should find out.

Full Committee Discussion of the Fair Treatment Subcommittee Report and Recommendations

William Harmon

Harmon presented seven areas, which this Subcommittee plans to discuss with the goal of bringing back recommendations to the full committee:

Seven areas:

• Nondirected donors
• Pediatric issues
• Quality of life
• Extended criteria donors
• Organ refusals, including paybacks
• Minimal listing criteria
• Unfairly treated groups.

Nondirected Donors

Harmon identified three types of nondirected donors: voluntary offer, living donor swap, and a swap with the deceased donor list. Evaluation of the donor candidate would be done by donor hospital and would include a psychiatric/psychological component and a determination of whether coercion or payment occurred. The other components are no different from those of the usual donors, although a more extensive psychiatric/psychological evaluation may be involved.

Regarding the choice of donor hospital, it is critical to maintain primacy of donor preference. When there is a swap, the donor must go where the transplant is occurring. It is up to the donor hospital to approve that donor. No donor may be forced upon the hospital. The determination of where the donor is going to be operated on should be no different from any other type of operation.

Allocation questions must also be addressed: Should a nondirected organ go to a hospital versus a consortium of hospitals versus the OPO versus the region. The allocation must be regulated and not left up to the individual hospital. The most economical way would be to follow the deceased donor list for that locality to avoid prolonged cold ischemia times. Designation to a group would probably not be ethical. A long discussion ensued about whether a donor should be able to designate to a child. We may be able to develop a logical and ethical basis that suggests that children are a special group.

Should the responsibility for donor follow-up fall to the donor hospital? This follow-up may be a research opportunity.

Pediatric Issues

There was some discussion on preparing a background paper on society's treatment of children including an ethical perspective, OPTN history, and the principle of preference in allocation.

Regarding children as donors, it was noted that many children are deceased donors. We need a position statement about using children as living donors. Delmonico and Harmon have written a paper on 40 children who were used as donors.

Some controversy exists about clinical trials in pediatric transplantation. Some attempts have been sabotaged by groups that do not want to include children in studies. We also need more information about what happens to pediatric recipients as they make the transition to adulthood. For example, who should be monitoring how they do? What happens when they exhaust their coverage for immunosuppressive drugs?

Quality of Life (QOL)

• QOL is an outcome variable of organ transplantation. What are measures of QOL (biological, sociological, psychological, economic, family, burden)?
• Tools for measuring QOL: There are some specific issues about whether the usual QOL tools apply to transplant patients.
• What is the purpose of studying QOL?
• We already have lessons from MELD/PELD. Are we ready for an outcome-based (benefit) allocation system?
• Outcome-based allocation may reinforce current outcomes. (The rich get richer.)

Extended Criteria Donors

• The definition of ECD insofar as kidney donation is clear.
• ECD for liver donation: Propose an SRTR study to determine threshold of viability of ECD. Eighty percent of ECD livers are from DCD and donors that yield single organs.
• Allocation of ECD organs: If we cannot place them, is it worth recovering them in the first place?
• Balance of organs per donor versus ECD. Are OPOs penalized for single organ ECD? There are financial disincentives for using ECD.
• Additional cost of transplanting organs from ECD is a penalty (differential recovery reimbursement).

Organ Refusals, Paybacks

Harmon posed the question of whether the payback system is bankrupt. He mentioned an SRTR/OPTN study. Better data are now being collected by the new UNOS system to document reasons for organ refusal. He also brought up issues around ECD and DCD organs and mentioned that the extra time needed for placing organs through the payback system compromises their viability.

Minimal Listing Criteria

• Reserved for liver transplant listing
• Review of current OPTN proposal:
  • MELD score less than 10
  • Regional review boards and exceptions (variable)
• Balance of minimal listing versus broad sharing: SRTR has already looked at this issue. The Subcommittee will seek data in this regard.

Unfairly Treated Groups

Harmon listed the following groups as among those that may be unfairly treated:

• Minorities: We need to follow up on SRTR data.
• Women: less likely to get listed or transplanted
• Insurance groups
• The elderly
• Diabetics.

ACOT Waitlist Subcommittee (C)
Breakout Session

Members

Nancy Ascher
Frank Delmonico
Hal Helderman
Bob Higgins
Diana Lugo-Zenner
Jim Perkins
Mike Seely, chair
Hans Sollinger

Mike Seely opened the meeting and suggested that the discussion would lay the groundwork for the upcoming meeting in November. He introduced three areas for discussion:

• Burden of disease
• Management of the kidney waitlist
• Heart utilization.

Burden of Disease

It was pointed out by members of the Subcommittee that this topic has some political edges that should not be ignored. The data must be closely examined.

Fritz Port from the SRTR started the discussion about comparing ECD and standard (kidney) transplants. He suggested it was important to look at what happens when the transplant is performed as opposed to when it was not performed. Upon receiving an offer of an ECD organ, the patient asks his or her doctor, "What alternative do I have?" After the discussion, they either decide not to receive a transplant, or they don't accept the one that's being offered and decide to wait for the next one. The key issue is the probability of receiving a good organ, not whether it's an ECD organ.

Key comment: Once an allocation is available and the call goes out, the person receiving the transplant has to decide whether to take it, or wait for another organ. There was some discussion about the OPO wait time. If the DSA wait time is short, it is more likely that a patient may elect to wait for a non-ECD kidney, whereas a DSA with a long wait time would compel the recipient to elect to take the initial ECD offer.

Jim Perkins concurred with the fact that a short waiting time would likely motivate the patient to wait for a better kidney.

Fritz Port responded that it depends on what part of the country you're in. With ECD you take the offer vs. waiting & try to separate allocation and acceptance questions. These are two different questions: (1) who gets the offer and (2) whether it's an ECD issue.

Henry Krakauer reviewed the elements of the multiple outcomes model, which encompasses five domains including mortality, psychological distress, and morbidity. A key notion to consider is whether or not we allocate based on results. Port suggested that in some way this is a consideration for kidney allocation.

Russell Wiesner stated that when we discuss burden of disease issues there's a strong possibility of "gaming." Currently, we're open for a great deal of subjectivity — everyone is doing whatever they have to do to support their patients. Allocation can't be dependent upon subjective measures.

There seemed to be consensus about looking at the burden of disease model in parallel with the model that is currently in place

Analysis of the MELD system shows that the three most important variables are:

• Age
• Race/ethnicity
• The transplant center.

It would be great to have a system that was based entirely on objective measures, but, how do we do it? It's very complex (e.g., you can't use age as the sole criterion).

Mike Seely related a conversation with Larry Hunsicker about how more information is preferred to less as decisions are made on behalf of patients.

Wiesner responded that it is a great concept Hunsicker is advancing, but there's still a need to look for more objective measures.

Henry Krakauer asked to what extent is it legitimate to use treatment as a predictor of outcomes? Is it morally sound to continue working with transplant centers that show poor results at the expense of those that are doing well?

Wiesner noted that the data that is currently being used is old — perhaps up to 2-3 years old. Is it right not to work with a center because of old data? Maybe they have some new surgeons now, or the old transplant team has departed. In these cases, the "old" data become useless.

Henry Krakauer asked, "What interventions are we using now to offset unworkable center policies, or the skill levels of the medical/nursing team? You must look at these variables, closely (although it may not be fair). It's a philosophical question that we return to again and again."

Diana Lugo said that this is all good discussion, but the Subcommittee doesn't have to address it now.

Someone mentioned SRTR data and how it is very familiar to patients now. Even the payors may stop using centers with a poor record of performance (i.e., minimal success rate).

Wiesner said that the most important consideration for third-party payors is cost.

Seely agreed that for both payors and providers the bottom line is most important. Of course, they want excellence, but there is a strong interest in driving down costs, as well.

Weisner cautioned about using data on the rate of re-transplantation as a measurement of quality. At the end of the day, saving patients and assuring their survival is the key measure.

Seely asked about the importance of the data related to uniformity of liver biopsies and how are we tracking what happened to these organs.

Frank Delmonico asked where the statisticians are taking this discussion (i.e., policy focus based on data collection and analysis thus far). Krakauer responded that the approach for determining if a transplant should occur is driven by an attempt to understand two issues: patient benefit and patient harm. Also important is the patient's prognosis and what can be done to optimize the prognosis. The second question is the most important.

The next question is how to optimize the prognosis by analyzing the five domains in the multiple outcomes model. Krakauer cited some examples using the Karnofsky score as a strong predictor of success. With respect to the burden of disease, there is definitely a need to come up with a system that offers better opportunities for auditing and minimizes opportunity for "gaming." Although he added, "You can't ignore subjectivity; invariably it will be part of the process."

Another issue that is being closely examined is this: How does all of this relate to better patient management? Whether to use a standard organ or an ECD organ for a transplant has bearing on patient management factors (morbidity, psychological distress, etc.)

Kress suggested that all of this talk regarding the details of how things get measured suggests we can come up with a better way to measure outcomes. Weisner said in regard to the Karnofsky score and so forth that it's important that we don't try to reinvent the wheel.

Delmonico agreed with all of this, but he wanted to know what can be done to manage the waitlist. Krakauer added that there are only so many organs for allocation and suggested that as a result only the person that is most likely to have the greatest amount of benefit should have a transplant. And, those that are least likely to benefit from a transplant shouldn't be on the list.

This dialogue led to more discussion about waitlists and how it remains increasingly important to view kidney transplants separately from heart, lung, and liver transplants. The individual who needs a kidney doesn't have the burden of making a life-or-death decision that is forced upon a heart or lung transplant patient. In the end, it's important to think in terms of transplant benefit (survival and quality of life issues with or without a transplant).

Port said that, based on the organ transplant needed, from a waitlist perspective, the Subcommittee might consider the following:

• Lung & Heart: urgency and transplant benefit
• Liver: urgency is the main consideration. (Seely suggested that gaming is reduced when the transplant decision is categorized as a benefit, or not urgent.)

Everyone agreed that at all costs "gaming" must be prevented, but there was ongoing discussion regarding how to establish criteria that would prevent chaos. There were some comments about the degree of benefit (in liver transplants?) and the ongoing need to develop outcome measures for this procedure similar to those that helped drive decisions associated with lung transplants. The conversation returned to factors that currently impact outcomes for non-liver/heart transplants: age, race and the performance of medical teams in the transplant center.

Krakauer, Weisner, and Kress continued by discussing issues related to (1) analyzing posttransplant data, (2) models that may be superior to MELD, and (3) how existing data on the transplant centers have not been looked at, or routinely collected. One participant mentioned how the data should be evaluated based upon the organ transplant (i.e., organ-specific analysis). Everyone agreed that the urgency (or benefit) issue depended upon the organ involved and that the Subcommittee should think about developing principles and presenting them to UNOS. All agreed that the approach should be organ-specific.

Krakauer suggested that the lung allocation model clearly demonstrated that patients did have an improved quality of life. His comments were not accepted well by one participant, a living lung donor who was participating in the discussion. She felt that lung transplants were too traumatic and didn't add anything to the patient's quality of life, labeled the procedure "medical experimentation," suggested that surgeons were making lots of money by doing this procedure, and said that children who receive lung transplants suffered disproportionately.

There some mention of the Vanderbilt study on quality of life for transplant recipients.

The discussion moved to kidney transplants. Everyone agreed they are beneficial and that more information on these benefits is needed and important. Then there was discussion about OPTN goals and whether or not the key issue should be survival, equity, waiting time, or quality of life.

Someone suggested that the committee establish a goal and then put into place the science that helps meet the stated objectives.

There followed a discussion about the impact on different ethnic groups. Port believed that equity was not an issue for lung transplants. Krakauer suggested the grounds for allocation might meet the following guidelines:

• Liver transplant: Survival
• Lung transplant: Survival & disability
• Heart: Morbidity
• Kidney: Not disability, but morbidity and mortality.

General comments following this discussion included these:

• There is a mix of data from which the assessment should be made.
• Survival benefit or a reduction in disability may override a slight increase in mortality.
• Start with the specific data and then use aggregate data to form judgments.
• The selection of criteria and methods must be flexible.
• Impact on the patient is critical (what is the prognosis, political issues, policy decisions).
• "Kill me or cure me" (how to look at the often circumstantial decision analysis associated with offering an organ and the individuals choice to accept-do they want to live longer?).
• In the real world there are random events that have an unpredictable impact upon survival rates

One of the "public" participants stated, "Patients don't care. They want the organ and at the time of the transplant they don't care about options."

Managing the Kidney Waitlist

The group turned to the question of what needs to happen in order to manage the kidney wait list. It was noted that there has been a dramatic drop in heart transplants. We should apply the "lessons learned" to develop similar methods of allocation for lung, liver, and kidney transplants.

The group recognized that the kidney waitlist is out of control but had different opinions about how to fix it. Delmonico suggested the committee turn to the experts (Port and Krakauer) for help. He asked them to talk about the benefit of transplants vs. the disadvantages of being on a long waitlist.

Port observed that all patients received benefit from transplantation, but those over age 65 shouldn't have a transplant. The sicker patients have a greater benefit than the healthier patients.

Delmonico added that the goal should be a more realistic kidney wait list and suggested the committee look more closely at the discrepancies of getting on the list. Port mentioned that removing older and sicker patients would reduce the wait list.

There followed a long discussion about using time on dialysis as the key determinant. Fritz Port added that the longer a patient is on dialysis there is a decrease in benefits of a transplant. He suggested that the average wait from start of dialysis to transplant is the same. Wiesner wanted to know if you save more people on the front end and Port noted that there is equalization over time.

Wiesner wanted to know ACOT's stance regarding using time on dialysis as a basis for accruing waittime, and there was agreement that equity is important, although moving to a system where dialysis is used as a key determinant for transplantation might have a disproportionate impact on African Americans.

There was discussion about

• Simulation models (the waitlist, time waiting for an organ, start of dialysis);
• Outcomes for minorities (worse, overall);
• Possibility of accepting the fact that harm may occur at the expense of better distribution; and
• This criterion might also lead to a longer waitlist.

Krakauer summed up the discussion by suggesting the committee should:

• Be clear about what it wants to accomplish;
• Determine if the policies help achieve the objective; and
• Assess if the policy can be implemented without harming a particular subset of the target population.

Seely suggested that weighing harm vs. systemic outcomes could lead to better management of the kidney waitlist.

Delmonico mentioned that managing the wait list depended on some additional factors, such as:

• Preparing the patient (are they ready for a transplant?).
• Developing more effective systems to track who is on the list and whether they are ready for a transplant.

Seely agreed the waitlist might be reduced if there were:

• More information collected regarding the status of the patient when the offer of an organ is made.
• At time of listing there was a way to ensure that the patient was ready for a transplant (i.e., no adverse circumstances, or conditions).

He also suggested that oftentimes there are patients on the waitlist who haven't made a visit to a transplant center and they're just on the list accruing wait time.

This was followed by discussion about eliminating gaming. Would switching to time of dialysis keep it to a minimum? Delmonico mentioned patients don't gain wait time on the list in Region 1 unless they're on dialysis.

There was extensive discussion about death on the list and death with a functioning graft — how this may exceed rejection as the cause of graft loss. Some in the group felt this would be a notion the public would find acceptable

Seely asked the group's opinion regarding the notion of minimal listing criteria. Some felt it was like rationing, but this may be something that can't be avoided given the availability of kidneys. Everyone felt something needed to be done to assist health care providers in making better judgments regarding when a patient gets on the wait list.

There were other suggestions for minimizing the wait list. Krakauer said the committee should (first) clearly state the objectives (what will be gained by employing the new strategy for reducing the wait list).

Delmonico reminded the group that it is not necessary to make a recommendation at this meeting. However, everyone seemed to agree that using time of dialysis as a determinant might help decrease the number of individuals on the wait list. It was a suggestion that most felt was reasonable and an example of multi-variant modeling that may prove effective for managing the kidney wait list.

Seely led a discussion regarding an April 22, 2004, summary of a "Heart Organ Utilization Roundtable Discussion" held at Rush University Medical Center (Chicago, Illinois).

After some lively discussion about the content of the memorandum the breakout session came to an end.

Full Committee Discussion of the Waitlist Subcommittee Report and Recommendations

Michael Seely

Seely identified three areas of focus: (1) burden of disease; (2) management of the kidney waitlist; and (3) the problem of heart utilization.

Burden of Disease

Seely suggested that this topic may be more appropriate for the Quality of Life Subcommittee. He explained that allocation programs may have to be differentiated on the basis of different organs. With livers, for example, we have moved to a medical urgency model (MELD/PELD). In our discussions, we may wish to define a set of principles to guide discussions.

Kidney Waitlist

The kidney list is ever-expanding. The driver, in this case, is waiting time. The Subcommittee discussed using dialysis as a starting point. The group was pretty much equally divided. There was some discussion of fairness issues. What can be harnessed from some multivariant modeling? Fritz Port gave some insights about applying a MELD-type system to kidneys. We should start to look into this so we can see if we need to consider alternatives.

Heart Utilization

Heart utilization rates vary by DSA (17% to 47%). The waiting time for hearts has decreased dramatically. A central issue is donor management. Are there efforts made to resuscitate and improve donors? We need to look at practices in different regions and conduct some peer reviews in low-yield DSAs. What is going on in these areas? Does the size and number of programs in a DSA affect utilization rate? Fritz Port suggested doing some modeling to calculate lives benefited. It may be possible to look at different-sized cutouts in different areas to see what happens.

Bob Higgins brought up the idea of a consensus conference to look at this problem.

Solarz asked if there had been thought to the concentric circle model because coastal areas are disadvantaged. Merion said that SRTR presented a family of models that look at effects of different allocation sequences and systems. What would be the effect if you allocate hearts to highest status patients locally? The model showed notably fewer deaths. One caveat: the models do not have a way to account for cold ischemia time. Within a 500-mile radius we would be within the safe 4-5 hour cold ischemia time for hearts. For lung, we tried to balance benefit-urgency model. You must be somewhat careful in these modeling exercises because there is not a good way to predict how behavior might change if listing/utilization/allocation changes. Unexpected, further changes may result. We have to use expert opinion to try to predict what might happen.

Seely said that we need to see what is going on in low-utilization areas. Higgins noted that fewer than 50% of consented hearts are utilized. This is a call to action for the thoracic community.

Public Comment and Closure

Carol Brotman addressed the Committee. She donated part of her liver to her husband 23 months ago. Her interest is advocacy with other people. In the State of Rhode Island, one senator has been moved to get involved in transplantation. Two bills have been introduced, one of which parallels Wisconsin's bill. The state is thinking to set up a trust fund to help pay for treatments for treating adverse effects of drug therapies. She is also interested in looking at issue of valuable consideration and the possibility of paying for related, nonmedical expenses for living donors. Assisting with expenses is very important.

Mary Ganikos spoke about the curriculum for driver's education classes, which is completed and will be printed shortly. It will be available on CD as well. That project has been completed except for dissemination and implementation. The package is available on the Division of Transplantation's Website: www.organdonor.gov/student.

Nancy Ascher then made a presentation to Jack Kress of a placque from all of the members of ACOT, which read as follows: "HHS Advisory Committee on Organ Transplantation (ACOT) commends Jack Kress for his exemplary performance and significant contributions in serving as ACOT's first Executuve Director from 2000-2004."

The members of the Committee then gave Mr. Kress a standing ovation and the meeting adjourned.

_____________

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