Welcome and Charge
Nancy Ascher, M.D., Ph.D., University of California, San Francisco; Chair of ACOT
Nancy Ascher, M.D., Ph.D., welcomed members of the Advisory Committee on Organ Transplantation (ACOT) to its third meeting. She expressed the hope that this committee would be ready to make several recommendations to the Secretary of Health and Human Services by the end of the meeting, and would continue to do so for some years to come. Dr. Ascher thanked the ACOT subcommittees and their chairs, the Scientific Registry of Transplant Recipients (SRTR), and Jack Kress for their work since the last meeting.

Logistics and Summary since Second ACOT Meeting
Jack Kress, Executive Director, ACOT
Jack Kress explained that this would be an open meeting, and welcomed members of the public to listen to all of the full committee discussions as well as the subcommittee discussions. Time would be set aside at the end of each day for public comment. Although each member of the public would only be allowed to talk briefly, Mr. Kress offered to distribute materials or e-mails on their behalf to committee members. Mr. Kress can be reached by e-mail at jkress2@hrsa.gov, and by telephone at 301-443-8653.

At the committee's first two meetings, ACOT members spent valuable time getting to know one another and setting goals and an agenda so that, by this meeting, the committee would have specific recommendations in some areas and progress to report in others. Committee members have now engaged in 16 2-hour teleconferences, read many articles and commentaries, conferred with colleagues in the field on scores of serious questions and issues, and requested dozens of tables and analyses from SRTR. The committee has sent innumerable e-mails back and forth to hone their thoughts and revise their recommendations, to ensure that their recommendations would be capable of realistic and prompt implementation. Mr. Kress assured committee members that their views are often brought forward in less formal contexts, and already have been considered by several departmental components.

The agenda for the first day would focus exclusively on an area that the Secretary has charged the committee to address, ensuring that the living donation process is as safe and effective as possible for both donor and recipient. The second day would be spent addressing many other concerns.

Mr. Kress introduced several individuals who have worked hard to support the committee's efforts: Sherry Whipple, Jade Perdue, Robin Imber, Joyce Somsak (the new leader of the HRSA Division of Transplantation), and Bill Hobson (the new leader of the HRSA Office of Special Programs).

U.S. Department of Health and Human Services (HHS)/Health Resources and Services Administration (HRSA) Update
Elizabeth M. Duke, Ph.D., Administrator, Health Resources and Services Administration (HRSA)
Secretary of Health and Human Services Tommy Thompson asked Elizabeth Duke to convey his very best wishes to committee members and thank them for all the work they do.

Dr. Duke reported that the Secretary is passionately committed to the issue of organ donation and transplantation and has made it abundantly clear since assuming office that this issue is at the heart of his agenda. On April 17, Secretary Thompson originated the Gift of Life donation program to help decrease the critical shortage of organs in the Nation. It infuriates the Secretary that, every day, 15 people die needlessly because not enough organs are available. We continue to lose the battle each day; the waiting list has grown from 79,000 to more than 81,000 in the 20 months since the Secretary assumed office. The Gift of Life program brings together employers, unions, and other groups to promote donation and make a difference in this statistic. Almost 3,000 organization partners are working with the Department on this effort, which will pay off in both the short and long term. Wherever Dr. Duke goes, she asks if people have discussed organ transplant with their families, because designating intent to donate on a driver's license or card is not sufficient.

This year, the Secretary has placed tremendous emphasis on disease prevention and health promotion, screening, and treatment to prevent suffering. The emphasis on prevention of the three most rapidly escalating conditions in our society (asthma, obesity, diabetes) has been particularly visible. The President's budget includes $20 million for five community-based sites to address this issue.

The Secretary wants help in addressing donation and transplantation. He recently wrote a letter to ACOT asking for its assistance in increasing donation, improving the lives of recipients and living donors of organs, addressing the need for a living donor registry, and employing donor advocates at transplant centers across the Nation.

On behalf of the Secretary and the Nation, Dr. Duke commended the efforts of ACOT members for all the work they do at and between meetings.

Discussion
Pam Skarda, of the Transplant Recipients International Organization, reported that her organization would like to offer suggestions concerning living donor registries and asked where to direct these suggestions. Dr. Duke replied that because this issue is on the agenda, ACOT offers the perfect forum for such comments, which can also be directed to ACOT through HRSA.

Living Donation Issues
David Conti, M.D.
Professor of Surgery, Albany Medical Center
Chair, New York State Committee on Quality Improvement in Living Liver Donation
David Conti, M.D., explained that New York State has a transplant council that advises the state health commissioner on issues related to transplantation, organ donation, and allocation. The council's 21 members are appointed by the governor and state legislature. After a live liver donor suffered a fatality in New York State and the institution in question was investigated, the health commissioner asked the council to review the entire process of live liver donation in the state. The transplant council formed a committee of 18 representatives from all five liver transplant centers in the state, four members from outside the state (including representatives from ACOT), a transplant social worker, a transplant psychiatrist, a live liver donor, and a live liver donor transplant recipient. This committee met four times and submitted a draft document for public comment.

This committee considered and vetoed a proposal for a moratorium in New York State on live liver donation and transplantation because this proposal would cost more lives. Instead, the committee decided that living liver donation should continue while the subcommittee worked to improve the entire process.

The committee unanimously agreed that each center that performs live liver transplants should establish a donor advocate team, empowered with the authority to say that a particular transplant with a particular live donor should not occur. The team's interests are to center on the well-being of the live donor and it will be responsible for structuring the process of informed choice. The team should include at least three individuals with expertise in transplantation, including a transplant social worker, a physician with expertise in transplantation, and a transplant coordinator or nurse clinician. The committee realized that no such team could act on behalf of the best interests of the donor independently of recipient events, but it did recommend that at least one member of the team be solely assigned to protect the interests of the donor and have nothing to do with the workup of the recipient. There must be unanimity among the members of the donor advocate team for a particular evaluation and process to continue, and any individual team member has the right to deny an individual's request to become a live donor. The team is responsible for ensuring that the individual who gives consent to be a live donor is competent, willing to donate, free from detectable levels of coercion, medically and psychosocially stable, and likely to benefit from the donation process. The team will establish as well as possible that the benefits to the donor and recipient outweigh the risks associated with the procedure.

Once a team gives its agreement, a two-week "cooling off" period is required in which the donor is to reaffirm and reflect before signing the consent form. Final say as to whether a potential transplant will occur will rest with the center.

The formation of this team was a vital component and safeguard of the continuation of live adult liver donation in New York State.

The committee also addressed who would be allowed to become a live liver donor. Individuals under the age of 18 years should be excluded from this process and the committee strongly recommended an upper age limit of 55 years. If anyone older than 55 years is considered, the center must document the reasons for doing so. The potential donor must also have a vital emotional relationship to the recipient and "good Samaritan" donations will not be allowed at this time.

All potential recipients will be required to meet United Network for Organ Sharing (UNOS) criteria and be listed for cadaveric transplant. They must have suffered at least one complication related to liver disease, have a Model for End Stage Liver Disease (MELD) score of 25 or less, and not have fulminant hepatic failure (because sufficient time would not be available to allow for informed choice).

The committee also identified performance criteria for those conducting live liver donation and transplant. At least two attending surgeons are needed with adequate competency and experience to perform the live donor procedure and a third to do the recipient operation. The committee specified the number of years and types of experience required for each of these individuals. They also specified that all live liver donors be cared for in an intensive care unit (ICU) for 24 hours after the procedure.

The committee recommended that New York State immediately establish a live donor registry. Through the process of evaluation, donors should be informed that the transplant surgeon will follow their healthcare status for life after they donate, with mandatory reporting on outcomes. A donor survey was developed in New York State and sent to 400 live liver donors to assess their experiences and concerns.

The recommendations are being finalized and will be presented to the full transplant council in mid-December before being forwarded to the health commissioner and department of health. Dr. Conti believes that the commission is likely to adopt many or all of these recommendations and ask transplant centers to comply with them immediately.

Discussion
Dr. Ascher asked if the committee's recommendations will be reviewed on a regular basis. Dr. Conti replied that the document will be reviewed annually by the transplant council, which will make modifications based on new scientific changes or outcomes.

In response to a question from William Harmon, M.D., Dr. Conti clarified that these recommendations are for adult-to-adult, not adult-to-child liver donations.

Dr. Ascher asked whether, in addition to its recommendations regarding the experience of transplant surgeons, the committee addressed ongoing activity. Dr. Conti replied that the committee did not do so, but it should specify the number of procedures that transplant surgeons must perform yearly.

Robert Higgins, M.D., asked about the consequences for teams that do not comply with the recommendations. Dr. Conti replied that the committee was not charged with addressing this. He suspects that the commissioner will give this charge to the transplant council once the department of health adopts some or all of the committee's recommendations.

Catherine Crone, M.D., asked if the questionnaires were also sent to family members of donors. Dr. Conti explained that the committee chose to send the surveys only to donors, and anticipates receiving as many as 80 percent of the surveys back. The donor advocacy team is responsible for ensuring that the family is involved in the process to some degree.

Barry Kahan, M.D., Ph.D., asked if the committee reviewed information on the morbidity of donors. Dr. Conti replied that the committee only had information on mortality available, which is why it believes so strongly that mandatory reporting is needed on the health status of donors.

Paige Cottingham-Streater, J.D., asked how the committee determined the length of time for the cooling off period, and inquired about situations in which less time is available to make a decision. Dr. Conti explained that while the committee members agreed about the importance of a period of recognition and reaffirmation, they found it more difficult to agree on a timeframe for this period. Consensus was ultimately reached on 2 weeks because this provides some time to reflect on the process, without risking deleterious adverse consequences for the recipient. The committee also thought it very important for a member of the donor advocate team to be a witness on the consent form.

A member of the public asked about the independence of the donor advocacy committee, and suggested that someone who is not part of the transplant system might be more likely to speak up when the potential donor's well-being is threatened. Dr. Conti explained that the requirement of unanimity and the veto power of each team member require strong knowledge about transplantation. The team could not look out for all of the interests of the donor without knowing about the process and the recipient. The final recommendation says that at least one member of the team should not be involved in the workup evaluation of the potential recipient.

Subcommittee Reports and Recommendations on Living Donation
At this point, four ACOT subcommittees met to discuss issues and develop recommendations.

When the full committee reconvened, Dr. Ascher read aloud a letter from Secretary Thompson to ACOT. In this letter, the Secretary asked ACOT to provide recommendations concerning three issues related to living donation:

The subcommittee chairs reported on their deliberations and recommendations concerning live donation.

Report of Subcommittee 8: Clinical Issues
Francis Delmonico, M.D.
Francis Delmonico, M.D., listed the elements of consent that Subcommittee 8 identified for live organ donors. The elements include informing the donor of alternative procedures or courses of treatment, such as laparoscopic nephrectomy for kidney donors, and the merits of each alternative. Other items to address include the immediate recovery period, foreseeable risks, potential psychological effects, reported national experience, statistics on risks to the donor and recipient, and the survival benefit to the potential recipient. Participation in live donation is voluntary, so the consent process should emphasize that the potential donor can opt out at any time and they have the right to obtain more information about the procedure. The potential donor should be made aware of potential psychological benefits, but although the donor might derive some benefit from having a previously undetected medical problem diagnosed, they will derive no medical benefit from the donation procedure itself. Potential donors should be informed that future risks or medical uncertainties may not be identifiable at the time of donation. They should also be aware that although they may be reimbursed for personal expenses related to donation, they may not be compensated by monetary or material gain by federal law.

The subcommittee felt strongly that centers have the responsibility to advise donors that their existing health and disability insurance may not cover the potential long-term costs and consequences of donation. This is a major concern of potential donors and the committee has the responsibility to pursue this issue, even though it may not be able to make a formal recommendation to the Secretary at this time.

Donors must be informed that centers will need to follow them over the course of their lives and will share donor identity and other information with registries that are legally charged to follow donor outcomes. The subcommittee recommended that the information collected from all live donors include demographics, operative and perioperative events and complications, midterm morbidities, sentinel and long-term follow-up events, and quality of life data. However, donors need assurance that their interactions with the transplant center will follow the rules of confidentiality that govern all patient care relationships.

The language used in the consent process should be no higher than the 8th or 9th grade level. The information involved in the consent process is quite sophisticated but the center must verify that the donor does understand all of it. An independent interpreter who is not a family member or friend of the donor should be provided for donors who do not understand English.

The subcommittee assimilated all of these elements into two model consent documents that were presented to ACOT. The subcommittee suggested developing an evaluation consent form and a separate consent form for the surgical procedure. The attending physician should sign the consent forms and someone with a significant relationship to the potential donor should also be involved in the consent process.

Some additional elements are appropriate for live liver and perhaps lung donation but might not be necessary for kidney donation which is better established.

The subcommittee suggested that trained, independent donor advocacy be provided to help potential donors understand the process, procedure, risks, and benefits of live organ donation. The advocate or team should explain the medical, psychological, and financial implications to the potential donor. If the donor and advocate decide not to proceed with the donation, their decision is final. If they recommend proceeding and the transplant team says no, the final decision as to medical suitability remains with the transplant team. If the donor wishes to donate but the advocate counsels against it, the advocate or advocacy team has the responsibility to explain their reasons to the potential donor.

The independent donor advocate or advocacy team members must be medically sophisticated in transplantation and know the transplant center's data. The advocate or team should be trained to recognize psychological pressures (external and family related) and discuss these with the potential donor. Advocates and teams must be able to carry out their responsibilities with the knowledge that their decisions will not affect their positions within the transplant center.

Given that the advocacy process occurs in the transplant center among medical colleagues who regularly interact professionally, the advocate will not be totally independent of information on the recipient. But the donor's well-being and care are the responsibility of this donor advocate, independently of the recipient's interests.

As a result of its discussions, the subcommittee on clinical issues recommended:

1. That the elements and ethical principles of informed consent as espoused by the subcommittee be implemented for all living donors;
2. That there be donor advocacy to assure that these elements are applied to the practice of all live donor transplantation;
3. That there be a registry established for the follow-up of all live donors, funded through HHS; the content and administration of this registry should be established by HHS, possibly through a request for proposals (RFP) presented to the community by HHS; and
4. That there be a process of certification that verifies the qualifications of a center to perform live liver or lung transplantation.

Discussion
Amadeo Marcos, M.D., believes that it would be undesirable for a potential donor to agree to be evaluated and then refuse to have the surgery, so both surgery and the complications should be included in a single consent document. Dr. Delmonico agreed that it is reasonable to object to having the process verified by initial consent and then subsequent consent. Kathy Turrisi, R.N., M.S.N., explained that the first consent details what occurs in the evaluation process and includes surgical consent. The second is the surgical consent itself. A cooling off period should occur in between the signature of these two consent forms.

Dr. Marcos asked when in the complex donation process the advocate or advocacy team will become involved. Dr. Delmonico replied that New York State has a very detailed algorithm for this. The donor advocacy team should not become involved if it is obvious to the transplant team that a potential donor is not suitable. Once the transplant team has information regarding the potential donor's suitability, the donor should be introduced to the donor advocate or team to obtain information about the donation process and procedures.

Dr. Kahan pointed out that the additional standards for liver donors imply that living donors in other categories receive less rigorous treatment or that liver donation is somehow different from other forms of living donation. Dr. Delmonico explained that the elements of informed consent should apply to all live organ donors. But given the risks of liver or lung donation, centers should consider certain additional elements. Dr. Delmonico preferred not to include the additional elements if the committee is concerned about these, because they are relatively minor compared to the other elements and principles brought forward. Dr. Kahan suggested that the additional elements be included for all live donations.

Dr. Williams suggested that the advocate or team become involved when the first consent is initiated to undergo the evaluation process. Dr. Marcos suggested that the involvement of the advocate be continuous.

Arlene Locicero asked about confidentiality of the follow-up of living donors, because, if information on the consequences of their donation were made available to individuals outside the transplant center, this could have an impact on future employability and other issues. Dr. Delmonico explained that the interactions and relationships between the physician or advocate and the potential donor are confidential. But the donor must be aware of the intent to collect follow-up information for a donor registry to provide information to future donors about the consequences of donation.

Ms. Turrisi noted that the donor advocate would be involved throughout the whole process and the relationship would not end when the transplant occurs. Some donors feel that once they have undergone the donation, the center is less interested in them, but the registry and donor advocate's continuing involvement will ensure that the donor's well-being continues to be addressed.

Partial Report of Subcommittee 3: Liver Allocation Review
Larry Hunsicker, M.D.
Larry Hunsicker, M.D., reported that Subcommittee 3 supported making the living donor consent process more consistent across centers. Although most centers have a consent process, substantial inconsistency exists in the process through which consent is requested and given. The subcommittee also agreed that the issue is not so much providing a well-written piece of paper, but ensuring that the patient understands the entire process.

Ascertainable differences exist between live kidney and liver donation. The subcommittee agreed that adult-to-adult liver donation is still sufficiently unsettled to justify providing a formal donor advocate. The donor advocate is not likely to be an individual because the advocate must address so many different issues. It is impractical for the advocacy team to be independent of the transplant center, but at least one member should be totally independent of the liver transplant program. The advocate must be distinguished from a guardian ad litem in that an advocate makes sure that the individual can make an authentic individual choice, while a guardian ad litem makes the choice in place of someone who is not able do so. The subcommittee did not support veto power for the advocate out of concern that the advocate might veto a decision by a donor who understands and is willing to accept the risks. The advocate should focus on making certain that potential donors are well informed of their choices and on helping them to make a choice that is not coerced.

The subcommittee supported a registry for living donors to answer certain questions. A short-term registry that collected information on 6-month outcomes of all donors would not be sufficient because most major complications of liver donation occur beyond that period. The subcommittee supported the development of a long-term registry, but maintaining such a registry would be very expensive for transplant centers. The costs of maintaining such a registry would also be high for patients, because the registry should collect information on blood pressure, creatinine levels, and other tests whose costs would not be covered after the first 6 months post-donation.

The risks of live adult-to-adult liver transplant are still not well known and diffusion of this technology should be limited until more information is available. However, subcommittee members strongly agreed that they did not want to establish any program that grandfathered in existing centers without providing other centers with a mechanism for beginning to offer the procedure. The subcommittee therefore supported a certificate of recognition to acknowledge institutional readiness. Such a certificate offers three potential benefits:

Requirements would include:

The certificate would be a time-limited endorsement, subject to review perhaps every 2 years or upon changes in major medical and surgical personnel. The subcommittee plans to begin to develop the rules for this certification program but would leave the execution to another group, perhaps the OPTN.

The subcommittee plans to consult with major professional organizations involved in liver transplantation, nursing and coordinator personnel, transplant administrators, and others on its proposals. The subcommittee also plans to make its proposals generally available and request input in writing from liver transplant centers and patient-oriented organizations. The subcommittee could collect comments and engage in discussions with lead institutions by the end of March 2003, and develop final recommendations for the next ACOT meeting.

Discussion
Dr. Williams asked what would happen if a new center wanted to open in an area that did not have enough volume to sustain two centers. Dr. Hunsicker replied that the subcommittee did not address these certificate-of-need issues. The process would establish the minimum standards of quality for centers, not the maximum number of programs.

J. Thomas Rosenthal, M.D., asked why the subcommittee did not charge OPTN with developing the criteria for centers that offer live liver donation. Dr. Hunsicker explained that the subcommittee was charged with developing some criteria, but would be happy to turn this over to the OPTN. A representative present from the OPTN said that the OPTN would be happy to work with ACOT in the best interests of patients to address these issues.

Partial Report of Subcommittee 1: Kidney and Pancreas Allocation Review
William Harmon, M.D.
Dr. Harmon reported that at the last ACOT meeting, Subcommittee 1 recommended a registry of living kidney donors to define the risks of this "low-risk" procedure and address the allocation of cadaveric kidneys (wait time and consequences), financial barriers, and access to transplantation. The subcommittee suggested that this registry be called Health Follow Up for Living Donors (HealthFULD). The subcommittee also recommended clarification of the fact that kidney transplantation is a life-saving procedure.

Many reasons exist to develop a registry to follow up on living kidney donors. A retrospective analysis of 10,000 kidney donors found that two deaths and one donor in a permanent vegetative state had been reported. Regardless of the size of the denominator, this numerator is very difficult to accept in the kidney transplant community. Even though the incidence appears to be low, until that figure is zero, donors must be tracked. At least 50 previous donors are on the waiting list and this also represents a major concern, as does the dramatic increase in the number of living kidney donors; in 2001, the number of living donors exceeded the number of deceased donors, and the number of living donors is rising exponentially. Dr. Harmon wondered if recipients and programs are becoming desperate, which would be another reason to define the risks of donation. The information that is currently available on risks to donors is based on very old studies. Potential donors need accurate contemporary information, including the financial impact of living donation, lost wages, insurability, and employability. Potential donors also need to know about the positive impact of donation because when a living donor takes a kidney patient off dialysis, society realizes a saving.

The subcommittee recommended that the proposed registry capture all donors for at least 5-10 years because 30,000 to 50,000 donors are needed to capture low-frequency events. Donors will need incentives to stay involved, as tracking them will be very difficult. Essential data elements include survival, hospitalizations, renal function, blood pressure, proteinuria, work status (employability), insurability, quality of life, and quality of the donation process.

The subcommittee estimated that the registry would cost more than $1 million a year, but this must be balanced with the financial benefits from removing the recipient from dialysis. The National Institutes of Health (NIH) are not likely to fund such a registry because it would respond to a public health need for information on the risks of the procedure, which is not a scientific question. Rather, the costs of the registry would probably fall elsewhere within HHS.

Transplant centers must enroll patients in the registry but cannot be responsible for all of the follow-up because they are often unable to locate donors. The best way to track this information is through contractors. An additional small contract should be issued for a survey of the living donor kidney literature to obtain data to support judgments.

The South Eastern Organ Procurement Foundation (SEOPF) has an insurance program for donors, based on the national marrow donor model. The donor receives this insurance in return for agreeing to have this kind of information tracked. SEOPF has enrolled approximately 100 donors from four centers so far, and this type of insurance might serve as an incentive for donors.

Kidney transplantation is a mature medical procedure, as the first successful renal transplant took place almost 50 years ago. The informed consent process is well established and functions well. The subcommittee saw no need to change or prescribe informed consent for the hundreds of programs currently offering live kidney transplant, as no evidence exists of deficiencies in this area, although subcommittee 1 expressed no objection to the distribution of the model forms developed by subcommittee 8. Should a registry be established, then this will need to be mentioned in the informed consent process.

Professional organizations have developed recommendations for the living donor process, including consent. The subcommittee suggests that transplant programs be familiar with and reflect these recommendations and the recommendations of ACOT. A survey should be initiated to confirm that the process is developed and functioning well in all centers to support public trust. This review would not be done with the intent to close down programs but to ensure that programs are complying with appropriate guidelines. To enhance public trust, all programs should show that they comply with these recommendations and the recommendations of Subcommittee 8.

Subcommittee 1 does not believe that a donor advocate is necessary for living kidney donation because it is a mature procedure. The need for a separate advocate should be reviewed after the living liver donor advocate experience has matured.

Because every donor is an altruistic donor, the subcommittee referred to "non-directed" donors and suggested that they do not require separate processes. The SRTR found that graft survival from all types of living donors, whether related or not, is better than from cadaveric donors. Non-directed donors are relatively new and, in some cases, experimental. But all of the elements of appropriate care and safeguards for living related kidney donors should also apply to non-directed donors. Individual centers must decide if special elements of evaluation are needed for these donors, such as increased psychological and psychiatric testing. Some subcommittee members thought that such donors should have an advocate, but the subcommittee decided not to recommend this specifically because data are not available so far to support this need.

Centers do not need to be certified for non-directed kidney donation because it is not substantially different from directed living kidney donation. The subcommittee did not have enough time to address the allocation of organs from non-directed donors and will consider this issue by the next ACOT meeting.

The subcommittee agreed that centers do not need certification for living kidney donation beyond the UNOS and state health requirements.

Discussion
Mr. Kress explained that he had asked subcommittee chairs for an alternative to the term "registry." More than 20 organ registries exist around the country, but they collect information on prospective cadaveric organ donors. Mr. Kress wanted to prevent confusion between these registries and the proposed retrospective, follow-up registries for living organ donors and had therefore asked for additional suggestions.

Mr. Kress asked Dr. Harmon about the tradeoffs required by the need to minimize taxpayer expenses for a registry. He wondered whether the subcommittee would prefer to include more donors or more data elements, if a choice were necessary. Dr. Harmon replied that the most serious consequences occur at low frequency, so the subcommittee would choose fewer data points and more patients.

Carleton Young, M.D., stated that OPTN already maintains a living donor registry and asked about the relationship between that registry and the one proposed by the subcommittee. Dr. Harmon explained that if the OPTN registry provided long-term follow-up of patients over 10 years, the subcommittee would be happy to use it. But not enough data are available to answer long-term questions concerning how many donors end up on dialysis or need transplants, for example. Dr. Young suggested building on the OPTN registry, instead of developing a new one. Dr. Harmon would like to build on past efforts but little information, and no long-term longitudinal data, is available.

Dr. Hunsicker pointed to the importance of knowing what questions need to be answered before beginning to collect data. For live kidney donation, two questions must be answered:

1. What is the mortality associated with live kidney donation? Answering this question requires a census but not a registry, as the center has this information by the time the recipient goes home.
2. What is the long-term impact of single kidney nephrectomy? This was a big question 20 years ago that is no longer asked. Centers do need to know if the donor has renal failure, and this information can be obtained with postcards.

Some information is needed about donors, but more in liver than kidney donation. Until the questions are identified, the costs of collecting the data cannot be determined. It would help the Secretary if the committee did not simply say that it supported registries, but identified what information is required that can only be provided by registries. Dr. Harmon replied that the methods of collecting the data to respond to Dr. Hunsicker's two research questions are inadequate. Subcommittee 1 has defined what information it wants to collect.

Dr. Kahan believes that two of the three donor fatalities were due to initial attempts at laparoscopic nephrectomies. Dr. Delmonico replied that 5,000 of the procedures were laparoscopic and 5,000 were open, and all of the deaths were associated with the former procedure. Dr. Harmon added that new procedures will continue to be developed, and the standards for those procedures must be known. Dr. Kahan suggested that the rate of 3 deaths per 10,000 reflects the fact that this procedure is new and may not reflect the current situation, now that the procedure is no longer new.

Dr. Williams disagreed that an advocate is not needed for living kidney donation because the procedure is mature. An advocate is needed because donor interests, center interests, and recipient interests are at odds with one another. The advocate's role is to protect the donor's interests, which can be compromised in any of several circumstances. Living kidney donors have the same long-term concerns regarding health, liability, employability, etc., as living liver donors.

Dr. Harmon believes that an inherent conflict of interest arises when a member of the transplant team conducts the donor evaluation. Given that the subcommittee is not aware of practical conflicts of interests, it is not clear that a great deal of additional expense and effort should be given to a program that is working well, especially before the donor advocate concept has been tried in a program that has more problems.

Dr. Rosenthal argued that the notion of an advocate is embedded in the practice of having different groups evaluate the donor and the recipient. This practice is followed by most kidney programs, and appears to work reasonably well. A Joint Commission-like review of each program would ensure that the needed elements are in place without imposing a new bureaucratic format. What is proposed for liver programs is actually a reflection of what already exists in kidney programs.

Deborah Surlas, R.N., suggested a survey of living kidney donors to learn how well informed they were of complications, what information they were given, and their feelings after the donation process.

Dr. Williams pointed out that even though living kidney donation is considered a "mature process," information is lacking about several issues, such as the morbidity rate and abandonment of donors. These issues need to be explored.

Dr. Delmonico reported that the clinical issues subcommittee is not seeking to impose or prescribe a new bureaucracy or additional costs. But all live organ donors should be in contact with an individual whose responsibility is the donor's well-being and interests. Dr. Harmon believes that this concept is already in practice. But if programs are reviewed, this will make the public aware of this practice. Dr. Harmon is not denying the need for an advocate but, rather, the need for new kinds of bureaucracy.

Donald Stablein, Ph.D., suggested that obtaining funding from an entity outside the transplant center would be unnecessary. Dr. Delmonico agreed. The clinical issues subcommittee acknowledged the limitations of the word "independent" but wanted to convey that this advocate had responsibility that was independent of recipient interests.

Ms. Solarz was concerned about the suggestion that fewer data elements might need to be collected for the retrospective registry due to financial concerns. So much needs to be known, including psychosocial consequences and access to the transplant team after the transplant. This information would provide an understanding of not just the donor's medical health, but how the donation affected the life and well-being of the donor immediately following the procedure and for several years thereafter.

Dr. Crone suggested that with the low rates of complications associated with living kidney donation, some centers do not pay as careful attention as they should to the donor's well-being.

Hans Sollinger, M.D., Ph.D., reported that all three deaths from donor nephrectomies occurred because of technical mishaps or incompetence, and donor advocacy will not reduce such donor deaths. The greatest need is to ensure that those performing these surgeries are technically competent. Dr. Sollinger expressed concern that the additional mechanisms suggested might distract transplant teams from the technical issues on which they need to focus.

Dr. Ascher summarized the discussion as pointing to the need for a continuum from the practices in place for living kidney transplantation to more rigorous processes for the newer procedures. She is also concerned about adding paperwork. Patients are very distrustful of the present system and this distrust needs to be addressed.

Partial Report of Subcommittee 2: Heart and Lung Allocation Review
Bartley Griffith, M.D.
Bartley Griffith, M.D., explained that living lung donation was introduced in 1997, and only 35-55 of such donations occur each year. Both lungs are removed from the recipient and replaced by the lower lobe from two different related donors, and the risk to the donor is approximately five percent, although this is balanced by the benefits to the recipient. Recipients are typically small individuals with cystic fibrosis, and generally have full lung capacity after the transplant, with approximately 50 percent survival at 5-7 years. Very few centers conduct this procedure because the target population is diminishing as medical care improves for patients with cystic fibrosis.

The procedure requires a steep learning curve, and centers must be staffed by highly skilled transplant team members. Subcommittee 2 supports the development of guidelines that are consistent with those of other high-risk living donations, especially liver. The minimum requirements for a program to perform living lung donation include informed consent, donor advocacy, institutional and professional readiness, and a registry.

Discussion
Dr. Marcos asked about the mortality rate quoted for the potential donor. Dr. Griffith always tells potential donors that the mortality rate is not known, but the risk for a healthy donor younger than 55 years is approximately two percent. Dr. Marcos noted that the mortality rate for liver donation ranges from 0.2 to 0.4 percent, so the mortality rate from lung donation is significantly higher. Dr. Griffith explained that living lung donors receive a huge amount of scrutiny and care.

Public Comment
David Olson stated that his father donated the right lobe of his liver to Mr. Olson's mother, and his father had to be transplanted later as a result of complications. Today, both of Mr. Olson's parents are doing very well.

Mr. Olson was very encouraged to see that ACOT is promoting and advocating the sharing of information by hospitals, and he would like to see a national registry that includes pretransplant information. Transplant centers need psychiatrists on staff to determine whether a potential donor should proceed. Mr. Olson's family also supports the concept of a donor advocate, although his parents received top-quality care and were aware of the risks. So many people need life-saving liver transplantations-17 people who were alive this morning are no longer alive this afternoon because of the organ shortage. ACOT should propose a living donor registry to Secretary Thompson.

Nancy Scheper-Hughes, Director of Organs Watch, has conducted research on living donation in Moldova, where people sell their organs. In her experience, the donor's risk of death depends on their initial health, living conditions, and type of labor. Of the 300 living donors she learned of in Moldova, 3 had died. Most living donors in the United States today are fairly well protected and educated, and have medical insurance. But as the procedure becomes more widespread, poor, uninsured Americans with a heavy load of disease or vulnerability to infections will be at greater risk. The current statistics on donor deaths may not represent the entire population of potential donors.

Rhonda Boone stated that her husband died in 1999 after being a living liver donor at the University of North Carolina. Ms. Boone shares ACOT's desire for changes to protect living liver donation, including a national registry, donor advocacy, and an adequate informed consent document. In spite of the committee's hard work at its May meeting and since that time, Ms. Boone is more determined than ever to continue her efforts to let Danny Boone's tragic story make a difference in all aspects of organ transplantation.

The work of Dr. Conti and the members of the New York State committee will have a tremendous impact on living donors everywhere, as will the current work of ACOT. The steps proposed would have made an enormous difference to Ms. Boone's family if they had been in place before June 1999. Mr. Boone played a small part in the protection this document will offer to people in New York State and ultimately across the country, as officials from the North Carolina Department of Health and Human Services have agreed to make their state one of the first to follow the lead of New York State in offering the proposed protections to living donors.

Ms. Boone has brought these issues to the attention of the governor, state senators and representatives, and U.S. Senator John Edwards. Ms. Boone will meet with Senator Edwards to obtain his support for the Organ Donor Improvement Act, which contains provisions for a national registry of living donors. Ms. Boone is also in contact with NIH to offer information on Mr. Boone's case that could be helpful to some of the institutes' research. Ms. Boone has made the same offer to Dr. Conti's committee, and would be happy to share this information with ACOT as well.

Even though improvements are occurring rapidly, Ms. Boone is still haunted by one question: How does the potential living donor say no? New York State provides a medical excuse to the living donor who wants to decline. But Ms. Boone wondered how potential donors could live with themselves if they take the medical team up on that offer and the recipient dies. As soon as an individual begins considering whether to become a living donor, there is no guilt-free way out. When any potential donor's advocate team has the slightest doubt, it would be much easier for the potential donor to be told they may not donate than to have to make the decision. For that reason, the final decision should be made by the donor advocate team.

Dr. Ascher had advised Ms. Boone not to judge the entire transplant community by the actions of just a few, and Dr. Ascher was right. Ms. Boone has been encouraged to continue her efforts by several members of the transplant community, who are all working toward the common goal of protecting everyone involved in living liver donation. Ms. Boone was grateful for the opportunity to continue her efforts and to honor Mr. Boone.

Kimberly Tracy is a registered nurse who donated a kidney to an infant who is doing well. But she has suffered some health complications and no one from the transplant center has contacted her. Some donors might not have any medical complications after the surgery, but they might receive substandard care. Ms. Tracy's bed linens were not changed, for example. Most complications occur postoperatively, and data must be collected on these. When Ms. Tracy was released from the hospital, she experienced breathing difficulties and abdominal pain. Her physician discounted these problems, but Ms. Tracy later learned that these were serious complications. Ms. Tracy pointed out that, although living kidney donation was referred to as a mature process, a protocol for follow-up is needed. Ms. Tracy also supports the certification of living donation programs and suggested that a few donors join the committee to provide feedback.

Wayne Meyer and his wife are living lung donors, although their daughter died from complications of the surgery. Mr. Meyer is grateful for the continued work of this committee, which is doing a wonderful job. He fully supports donor advocacy but asked that minimum standards be established to ensure independence. Some information should not be shared with the donor advocate, such as the recipient's place on the list.

Mr. Meyer also supported the recommendations of Subcommittee 8 regarding informed consent. Twenty months after the operation, Mr. Meyer still does not know why his daughter was removed from the waiting list. The informed consent process should include an explanation of how the list works, because this is important for making the right decision. Mr. Meyer's wife experienced some postoperative troubles but never received a follow-up call from the transplant center. Mr. Meyer wondered how information is collected on how donors do postoperatively. Mr. Meyer and his wife would donate their lungs again to their daughter.

A member of the audience stated that little was said about confidentiality of the information collected in the registry, which is important for obtaining health insurance and employment.

James Shanteau, Ph.D., asked for clarification regarding the Organ Donor Improvement Act mentioned by Ms. Boone. Ms. Boone replied that this legislation was proposed by Senator Bill Frist of Tennessee. Mr. Kress added that this was discussed by ACOT at its last meeting, when an assistant to Senator Frist made a presentation to the committee.

Recommendations on Living Donors
ACOT members considered the following recommendations concerning living donors:

1. Regarding the Secretary's request for national disclosure standards, ACOT recommends that the elements and ethical principles of informed consent as espoused by ACOT be implemented for all living donors.

2. That there be established a donor advocate to ensure that these elements are applied to the practice of all live donor transplantation.

3. That a database of health outcomes of all live donors be established and funded through the U.S. Department of Health and Human Services. The Secretary had asked us the following specific questions:

4. That there be a process that verifies the qualifications of a center to perform live donor liver or lung transplantation.

Dr. Delmonico presented these recommendations, and pointed out that the only change made since the presentations of the subcommittees was to propose a donor advocate for all live donor transplant activities. The responsibilities of the donor advocate are defined as follows:

A trained donor advocate should be identified:

The recommendation about donor advocates was changed to include kidney donation because, although the provision of care for kidney donors is mature, every center should identify someone whose interest is the well-being of the live donor, regardless of organ. In addition, ACOT will recommend to the Secretary only that an advocate be identified and leave the application of this recommendation up to each center. The emphasis is on the responsibilities above, not the decision-making responsibilities.

Dr. Williams noted that the donor advocate's role must be active, not passive, as this individual or team must speak up when the donor's interest needs to be protected.

Dr. Ascher asked if ACOT members had any objections to any of these recommendations and none were expressed.

However, Larry Hagman requested clarification on the advocate's responsibility with respect to postoperative care. Dr. Ascher explained that the recommendation for a health outcomes registry or some kind of data collection implies that the long-term health of donors will be considered, but this will probably be done through the center and not necessarily through the advocate. Although postoperative care could be monitored by the advocate, this will depend on how the center functions. Ms. Turrisi added that the clinical issues subcommittee agreed that the advocate's responsibilities would not stop at the time of transplant, but would continue throughout the hospitalization process.

Mr. Kress added that the New York committee had agreed that the donor advocate team would maintain its responsibility to oversee the donor's interests during the hospital period and for some time thereafter, although not indefinitely. Mr. Hagman wondered whether this should be spelled out in the recommendation. But Mr. Kress noted that the committee is merely providing general guidance for the country as a whole and leaving the implementation up to each hospital or center and/or to each state's health department. The donor advocate is clearly dedicated to the donor's interests throughout the hospitalization period and after that, the surgeon and team are still responsible for the donor. Ms. Surlas cautioned against micromanaging transplant centers, as opposed to providing them with general principles to follow.

Ms. Solarz discussed the concept of an information resource center that would be external to transplant hospitals. Donors and their families may not have as much independence as would be expected without information. This center would provide information and links to information. Donors and their families could be in contact with the resource center long after they lose touch with their transplant programs to address questions or concerns about health, insurance, employment, or anything else related to transplantation. Access to a resource center should be part of the contract with the living donor equivalent of the SRTR or OPTN that has oversight responsibility for living donor transplants. Mr. Kress asked Ms. Solarz to provide a written description of the proposed center.

Mr. Kress noted that, during the remainder of the meeting, ACOT members would hear recommendations from several subcommittees and would have the opportunity to discuss and approve or disapprove of the recommendations. Mr. Kress would then e-mail all of the recommendations, including the recommendation of Ms. Solarz as well as the sample informed consent forms, to committee members. Dr. Ascher sought and received consensus support for this e-mail communication process for fully approving the recommendations, giving the Chair and the Executive Director of ACOT final wordsmithing authority over the final language.

Subcommittee Reports and Recommendations on Cadaveric Donation and Remaining Issues
The remaining four subcommittees met and the subcommittee chairs presented the results of their deliberations.

Report of Subcommittee 5: Improving Systemic Performance: The Law
Robert P. Charrow, J.D.
Robert Charrow, J.D., reported that Subcommittee 5 examined whether a demonstrable problem existed with first-person consent that could be addressed by modifying the law and whether such a modification would resolve the problem. The primary concern with first-person consent is what happens when a donor has expressed a wish to donate on a driver's license or registry and a family member objects to the donation. In many cases, the organ procurement organization (OPO) honors the request of the living family member instead of the deceased. The statistics make it difficult to draw any conclusions about the frequency of such situations. The subcommittee concluded that the existing law under the Uniform Anatomic Gift Act (UAGA) authorizes but does not mandate OPOs to accept the gift, which is consistent with the way in which other property is treated and the way in which the legal system generally operates. It would be difficult to change the law to require OPOs to accept an organ notwithstanding the family's wishes and, given the small "bang for the buck," the subcommittee decided to leave the section alone at this point, although the issue may be revisited at subsequent meetings.

Subcommittee members agreed that the legal and ethical constraints and concerns with respect to presumed consent are great and raise many issues. The concept is inconsistent with the general structure of the legal system and mores in the United States, and a recommendation to modify the law to create presumed consent would probably not be followed, so the subcommittee recommended no action in this area at this time, although, again, the issue may be revisited at subsequent meetings.

The current law prohibits financial consideration for acquisition of an organ or tissue and the subcommittee discussed whether this should be changed. Currently, the law does allow compensation for living expenses, travel, and lost wages. Subcommittee members suggested that living donors receive certain forms of compensation, such as moving up the line if they themselves later need an organ. The current law is insufficiently flexible to accommodate these concerns. The committee recommended that, through legislation, the Secretary be provided with the ability to conduct demonstration projects. In addition, legislation should be enacted to amend the National Organ Transplantation Act (NOTA) to authorize the Secretary to engage in rulemaking to define the term "valuable consideration." Under the current law, the Secretary does not have the authority to engage in rulemaking with respect to this section because it carries criminal penalties.

The committee recommended that:

1. Further review and demonstration projects are warranted. While certain organizations have recommended that donors or their families, as the case may be, be permitted to receive some form of valuable consideration, the legal constraints at the federal level counsel otherwise. Whether federal legislation is appropriate and the form that it would take are matters of concern to the subcommittee, and worthy of a full recommendation at a subsequent meeting. To provide necessary data, we recommend legislation authorizing the Secretary to conduct demonstration projects notwithstanding provisions of section 274e, title 42.

According to studies in the SRTR packet, approximately 700-1,000 organs are lost each year as a result of the actions of medical examiners and coroners, especially their refusal to approve donation. Some subcommittee members believed that this figure is an underestimate. Current law vests extraordinary discretion and pays extraordinary deference to the decisions of the medical examiner, and the system provides no checks and balances. Texas and New Jersey have modified the UAGA to address this issue. Texas law requires the medical examiner to be physically present when the organs are removed, and to justify any refusal. This has been effective and reduced refusals by medical examiners. The subcommittee's recommendation on medical examiners is:

2. Amend UAGA to add a new subsection at the end of section 4, as follows:

(d) If the medical examiner is considering withholding one or more organs or tissues of a potential donor for any reason, the medical examiner shall be present during the removal of the organs or tissues. In such case, the medical examiner may request a biopsy of those organs or tissues, or deny their removal. If the medical examiner denies removal of any organ or tissue, the medical examiner shall explain in writing the reasons for the denial and shall provide the explanation to the qualified organ procurement organization.

Discussion
Dr. Stablein supported Recommendation 1, which suggests that the subcommittee might be potentially interested in changing the law once more information is available. Mr. Charrow explained that the subcommittee would like to present the Secretary with two options:

1. If enough data are available, seek legislation to modify NOTA.
2. If insufficient data are available, collect data through demonstration projects to show whether the law needs to be changed.

Dr. Stablein wondered whether compelling demonstration projects are not currently being conducted because of the law. Mr. Charrow replied that the current law would preclude demonstration projects that offer valuable consideration. Dr. Shanteau added that a Kansas bill that proposed allowing the state to offer a tax deduction did not pass because of the UAGA. Howard Nathan noted that a state law in Pennsylvania in 1994 authorized compensation for funeral expenses but was stopped because of the UAGA. The state now has a plan for reimbursement for lodging or food expenses.

Dr. Williams noted that in its deliberations in June, the American Medical Association (AMA) agreed that studies like this should go forward. Once the data are produced, ACOT would review the data and make recommendations to the Secretary as to whether sufficient results are available to recommend changing the law.

Dr. Delmonico pointed out that the American College of Surgeons and the National Kidney Foundation oppose such demonstration projects, and asked whether the subcommittee considered distinguishing between demonstration projects focused on deceased donors and those involving live donors. Mr. Charrow replied that the subcommittee discussed the types of consideration that would be the best subjects of a demonstration project and did not favor the payment of cash to donors. But the legislation should not be so prescriptive as to undermine the purpose of the demonstration projects, as the Secretary needs a certain amount of flexibility and is unlikely to act in such a way as to engender controversy in Congress.

Dr. Delmonico asked who would shape the demonstration projects. Mr. Charrow replied that the Secretary would determine the funding vehicle and scope of the project, which would probably be announced in the Federal register. Emily Marcus Levine pointed out that if this authority goes through, ACOT can make recommendations to the Secretary about the types of such demonstration projects and whether public comment would be advisable.

Margaret Coolican asked what is to be rewarded. Ms. Cottingham-Streater clarified that the aim is not to offer a reward, but an incentive. Disincentives exist that may prevent donations in some cases, such as cost and future employability. The subcommittee wanted to ensure that those donating an organ would not be disadvantaged by their decision. One suggestion was to reimburse some of the funeral expenses.

Dr. Williams asked, if someone wants to donate and procurement does not happen for reasons beyond their control, they would receive the same incentive as the family of a patient in which procurement and donation occurs. The question is whether giving consent or the actual transplant is important. Mr. Charrow replied that this was beyond the scope of the subcommittee's limited discussion, but the motivating force behind valuable consideration should be discussed. The transplant community should follow some of the models of the blood banking industry with respect to valuable consideration. Most nonprofit blood banks, for example, do not accept blood that has been paid for.

Ms. Locicero asked about the impact of Recommendation 2 on the medical examiner's role in the justice system. Mr. Charrow replied that the legislation in Texas and New Jersey has not impaired medical examiners' ability to fulfill their responsibilities, as these laws ensure that organs needed for evidence in a trial are preserved. Dr. Kahan added that if a liver is fractured as a result of child abuse, the liver would not be used for organ donation. Prior to the Texas law, some medical examiners automatically rejected donation in homicide or child abuse cases, even though the organs involved (such as the brain) were not those needed for transplant. Medical examiners have access to the body after organ recovery and can examine any involved organs.

Ms. Locicero asked about consistency with respect to releasing the body for organ retrieval. Dr. Kahan replied that when the retrieval is done, the surgeon dictates an operative note that includes a description of all the organs retrieved, and this is incorporated into the medical examiner's report. Organ retrieval is generally done in the middle of night, and the body is available for the medical examiner by the next morning.

Michael Seely pointed out that the National Association of Medical Examiners supports donation, as do organizations of prosecuting attorneys. Generally, OPOs can accommodate almost any need of the medical examiner and would comply with almost any restriction. Mr. Kress has been in communication with the National District Attorneys Association, which is interested in considering and potentially endorsing this recommendation.

Dr. Harmon noted that Federal law does not preclude reimbursement of expenses or removal of disincentives. Federal employees, for example, are given 30 days of paid leave if they are living donors for transplants. An important distinction exists between financial incentives, on the one hand, and payment of expenses or removal of disincentives, on the other.

Mr. Kress clarified that the recommendation is not to endorse any particular demonstration project but simply to permit the Secretary to authorize such projects. Any projects would go through the full review process. The Kansas and Pennsylvania statutes would be permitted if the Secretary follows this recommendation.

Dr. Delmonico asked if the demonstration projects would focus on deceased donors, live donors, or both. Mr. Charrow explained that the recommendation pertains to both populations. Ms. Cottingham-Streater asked why the American College of Surgeons and the National Kidney Foundation do not endorse demonstration projects, and the reasons for the concern about projects that focus on live versus deceased donors. Dr. Delmonico replied that paying for live donor organs must be separated from the incentive to consent for deceased donor organs. A major ethical gap exists between these and the Secretary should not be sent a mixed message. Live donation should not be onerous and the community needs to take away the disincentives to these procedures. But live organ donation for the motivation of money is a major concern to many in the community. Mr. Kress suggested restricting the recommendation to projects pertaining only to deceased donors, but Dr. Delmonico believes that the committee needs to consider the consequences before endorsing such a recommendation.

Dr. Williams argued against focusing on the influence of valuable consideration on decision making, and addressing instead the basis of the potential for harm. One cannot harm a brain-dead person but the process of donating an organ can harm a live donor. An article in JAMA described the experience in India, where more widespread harm occurred than many may have realized.

Mr. Nathan agreed. The projects considered in the states were primarily aimed at increasing the number of deceased donors. Any demonstration project should focus on deceased donors. Mr. Charrow explained that the purpose of the demonstration projects is to collect data. Since these research projects would have federal support, they would need institutional review board (IRB) approval, and cash payments to living donors are inconsistent with federal legislation.

Dr. Hunsicker supports such demonstration projects. But further consideration of this issue is needed before an attempt can be made to reach consensus among ACOT members. However, Dr. Marcos believes that the group did reach consensus on making a distinction between live and cadaveric donors. The recommendation is to support demonstration projects to create incentives for cadaveric donation and the removal of disincentives to living donation.

Dr. Delmonico warned that even if this is the intent of the demonstration projects, ACOT members must make sure that this recommendation is not misperceived as supporting cash payment for organs, body parts, and people. Dr. Griffith also expressed discomfort at agreeing to this recommendation. The same funds could be used to incentivize donation without payment, such as through insurance.

Dr. Sollinger suggested that offering incentives could potentially be very important to increasing cadaveric donation. Perhaps one grant could be funded to support a good opinion poll on the public's response to incentives. Perhaps ACOT should suggest to the Secretary that he fund a well-conducted opinion poll for this purpose. Joyce Somsak replied that HRSA (responding to an earlier, informal recommendation by some ACOT members) has funded a poll from Gallup that will address some of these questions. Ms. Somsak stated that she would be interested in receiving further ACOT input concerning the questions. The questionnaire will need clearance from the Office of Management and Budget, and may be ready in 6 months.

Dr. Williams suggested that the only way to resolve these issues is to conduct the studies. Dr. Ascher suggested that the committee might be able to come to consensus through e-mail.

Partial Report of Subcommittee 2: Heart and Lung Allocation Review
Bartley Griffith, M.D.
Although the previous discussion addressed how to increase the number of donors, Subcommittee 2 is more concerned with doing a better job at collecting organs from existing donors. Good evidence is available to show that the risk of liver dysfunction and other problems can be reduced by improving the retrieval of thoracic organs.

Retrieval of lungs should incorporate the kind of standard ICU hemodynamic care that sometimes escapes lung donors. Studies are needed on how to increase the condition of donor organs, because such data are needed for appropriate decisions. Trying to resuscitate donor organs might be a good start. OPTN could be asked to consider a more classic approach, and this would not require a study. This is common-sense good hemodynamic management and should be implemented now on a broad basis.

This titrated care may cost the OPO approximately $10,000 per donor, and these costs need to be weighed against the potential benefits. In addition to adding hearts and lungs, titration would improve the condition of the organs that are implanted. Adding $20 million to the OPO budget would go a long way toward improving the condition of the subset of 6,000 donor organs that do not function well and do not contribute to multi-organ donation.

The subcommittee believes that phase 4 donor management, as described in the current OPTN critical pathway document, needs further elaboration and OPOs need to be funded to provide titrated care. A method is needed to ensure that OPOs do provide the appropriate standard of care in the community. A study should be funded to improve the donor yield of heart-beating and non-heart-beating cadavers.

Statistics indicate that 60 percent of hearts are not transplanted for some unexpected reasons. Of these hearts, 26 percent are not used because of poor function, which indicates the need for titrated care. The next reason is because the valves were used, which indicates that the hearts were not functioning well. The data that are currently collected provide little information. Dr. Griffith encouraged the Secretary to support the OPTN in its efforts to continue to improve this dataset.

Of 3,800 heart candidates, 1,500 are listed as inactive and have been inactive for more than 2 years. This might be because these individuals are receiving better care and do not need to be on the list any more. The proportion of inactive recipients for both hearts and lungs is much higher than for kidneys and other organs, which is typically closer to 10 percent. The number of hearts needed according to the list may be an overstatement, which Dr. Griffith referred to as the "crying wolf" syndrome. Dr. Griffith supported the continued push for medical indications for transplant as opposed to waiting time, which may be at the root of some of this confusion. Programs should be asked to consider uniform criteria for listing and delisting heart and lung candidates.

The committee's recommendation is as follows:

1. The Secretary of HHS should encourage OPOs and OPTN to develop and support the implementation of a standard of titrated care.

Discussion
Dr. Marcos suggested that ACOT develop the proposed titration standards. Some centers are actively involved in optimizing donor care and the cost should be passed on as a procurement cost without external funding.

Mr. Seely referred to the balance among all organ groups in trying to accommodate the needs of different organ systems. In some cases, the lung team is in conflict with the heart team over fluid balance. Some practical issues at this level should be addressed. Lung teams are often reluctant to use the expertise of pulmonary intensivists to start aggressive pulmonary care early on, even though OPOs pay for this as part of donor management. Dr. Griffith suggested that this would work if the patient is at a university hospital, but might be more problematic at a hospital where the surgeon has no privileges. Mr. Seely pointed out that the largest proportion of donors is at larger hospitals, where critical care medicine is relatively well evolved, and the critical pathway concept could operate more broadly.

Dr. Williams suggested that any recommendation must speak to more than the role of the OPO, because this issue falls in the interface between the OPO and the intensive care team. It is a struggle to encourage hospitals and OPOs to work together on required requests of families, and even more is involved in the management of donors. In addition, the longer donor management takes, the longer an ICU bed is occupied that could benefit someone else, which is particularly critical given the nursing shortage. A more detailed donor management process requires the involvement of an ICU nurse, which encroaches on the care of others. Dr. Griffith does not believe that this is a relevant resource issue. Hospitals must solve these conflicts and ACOT's job is to optimize the number of donor organs. ACOT should not take increased resource needs into account in its recommendations.

Mary Ann Palumbi, R.N., suggested that the OPTN thoracic committee decide how to improve donor management. The cost for OPOs could be included in the standard acquisition charge (SAC) that is passed on to the transplant center. However, diagnosis-related groups (DRGs) and third-party fees do not always cover such care. Given that OPOs currently have a budget of approximately $280 million, an additional $20 million does not seem excessive.

Mr. Nathan agreed that donor management is inadequate in many cases and in many parts of the country. The availability of intensivists and residents is part of the problem. Some programs have shown that if resources are dedicated to donor management, the availability of hearts and lungs will increase. But this requires an intensive effort and many resources that transplant centers are not prepared to provide.

Richard Laeng, from HRSA's Division of Transplantation, pointed out that the Secretary has addressed this to a certain extent by funding a clinical interventions grant program for $3 million in FY 2002, and another $3 million in FY 2003.

Ms. Surlas pointed out that the OPTN thoracic committee is developing criteria for listing and delisting patients. Another part of donor management that had not been mentioned is the care of critical patients waiting for teams to arrive at the center to recover those organs. Critical hearts and lungs, as well as other organs, will be lost if teams cannot arrive more quickly.

Dr. Shanteau suggested that if the need for hearts and lungs is overstated systematically because of inactive recipients and the number climbs each year, the accuracy needs to be increased. If that list is declining, this message should be disseminated.

Dr. Ascher asked if consensus exists among committee members for a system of titrated donor management, along the lines of the critical pathway analysis, or if the committee is satisfied that this has been sufficiently addressed through the grants program. Mr. Nathan believes that more will be required than the grants, because the cost of setting up the proposed donor management program will probably approach $20 million. Ms. Palumbi agreed. The goal of the proposal is to involve all OPOs, and having one or two centers offer improved donor management will not provide the desired result.

Roger Evans, Ph.D., distinguished research projects from the subcommittee's recommendation, which is for improved donor management, and this should relate to all organs. No further research is needed because this is known to be a better way to manage donors.

Report of Subcommittee 7: Multicultural Issues
Robert Higgins, M.D.
Dr. Higgins reported that Subcommittee 7 had asked SRTR for information on the impact of the Minority Organ Tissue Transplant Education Program (MOTTEP) on communities. MOTTEP, which is federally funded, is probably the most well-organized outreach program and informs African Americans of opportunities for donation. MOTTEP has fifteen chapters around the country, with regional programs in large cities. SRTR is still collating the information on MOTTEP, and more information will be made available to the subcommittee.

The subcommittee also discussed the fact that underrepresented populations have insufficient access to transplantation from dialysis centers. The subcommittee plans to track the impact of the OPTN board's decision to eliminate human leukocyte antigen (HLA)-B matching.

Donation rates in different populations have been calculated with three methods. One method compares donation rates to total evaluable deaths, which are defined as:

The subcommittee believes that the use of evaluable deaths to calculate donation rates has some merit, although more information is needed. When evaluable deaths are the denominator, donation rates are 71 percent higher in whites than blacks. The denominator used in the calculation determines how well certain groups perform.

Many patients on dialysis are not given the opportunity to be considered for transplantation. According to the data provided by SRTR, the relative risk of being referred for transplant evaluation between blacks and whites varies by state. Overall, the rate of referral for transplantation is approximately 50 percent less for blacks than whites.

The large discrepancies between state and national rates may be due to differences in insurance, so Subcommittee 7 requested data from SRTR on insurance coverage status by geographic area for dialysis patients who are listed for transplantation. The subcommittee learned that individuals with employer insurance, or with Medicare plus other insurance, have a relative rate of wait listing that is almost twice as high as individuals with Medicare or Medicaid alone. More minorities have Medicaid only than whites at the time of wait listing and time of transplant, although large regional variations exist.

Patients listed for transplant may change their insurance during the wait, given that they often wait for 2-3 years. At the time of kidney transplant, Medicare is the most common insurance. Once an individual is on the list, the relative rate of transplantation by insurance does not vary. Therefore, the lack of access does not occur on the list, but at the referral source, which is the dialysis center.

The subcommittee's recommendations are as follows:

1. Develop methodology to evaluate dialysis patient access and referral to transplant using existing data or a new source.

2. Health education program or coordinator on site in dialysis centers to provide education about transplant options.

If patients are not being referred, perhaps it is because they are unaware of this option. When patients begin dialysis, they now receive a package of information about the rights and obligations of the dialysis center from the Centers for Medicare and Medicaid Services (CMS). This material underscores the potential to be considered for transplantation. But dialysis patients may find it difficult to process this stack of papers. A program coordinator could provide patients with information on treatment options, including transplantation.

Dialysis centers and physicians fill out a form, and the subcommittee has tried unsuccessfully to locate these data, as they might provide more information on access to transplantation. Perhaps CMS or the Secretary should be asked for assistance in determining whether patients are referred from dialysis centers.

Issues for future discussion include:

Discussion
Diana Lugo-Zenner, R.N., M.B.A., had thought that a condition of participation for dialysis centers is referring patients to the transplant center for evaluation. But apparently, this is not happening. Dr. Higgins does not know if this is happening, and seeks proof.

Dr. Hunsicker said that the data from the form completed by transplant centers and physicians is available from CMS, and SRTR should be able to obtain this information. However, this form is completed at the initiation of dialysis and does not provide information on subsequent referrals. A great deal of literature, including some from SRTR, exists on referral rates from dialysis centers to transplantation. Dr. Hunsicker is more concerned about access to other organs and asked about referrals for patients with cardiac failure, liver disease, etc., as no national data source exists on the denominator. Dr. Higgins agreed that this denominator is an elusive number. Congestive heart failure represents the top DRG in the country, but it is difficult to determine where the need is or what the denominator is between African Americans and any other population, because the incidence of congestive heart failure is unknown.

Dr. Kahan suggested that this is an even more significant problem. Many dialysis units have urged transplant centers to have the dialysis nephrologist determine whether the dialysis patient is a candidate for evaluation. Just because the difference in referral rates is not significant does not mean that rates are close to ideal, especially for patients with social or economic challenges. These patients are "written off" by dialysis units and never come to the attention of the transplant community. Ms. Lugo-Zenner noted that some dialysis centers are owned by nephrologists, and the practices described by Dr. Kahan present a conflict of interest and are illegal.

Ms. Palumbi suggested that data are available through networks. Ms. Palumbi's network was able to gather information on rates of referral in Pennsylvania and found that the lowest rates of referral from dialysis centers to transplant centers were in African American women. However, each network has a certain amount of autonomy as to what type of information it gathers. CMS could require the collection of certain types of information, such as annual referral rates. This information could easily be collected. Ms. Palumbi added that her network is constantly inundated with requests from nephrologists to evaluate patients.

Dr. Delmonico supported the recommendation to collect more data. The wait list conference group is trying to develop action items with respect to these issues, and perhaps ACOT could coordinate with the wait list group efforts to encourage CMS to make much-needed changes.

Dr. Alveranga agreed that good data are available on kidney transplantation, but the data suggest that a large problem may exist. Between 1991 and 1996, black dialysis patients were only half as likely to join the wait list. Good data show that blacks on dialysis have a lower mortality rate, so the low referral rates are not due to poorer health. This discrepancy in referral rates needs an explanation.

Ms. Surlas helped design the packet of information sent by CMS to all patients who are beginning kidney dialysis. The information is mailed directly to the patient because nephrologists at dialysis centers were not allowing patients to have this information. Patients do need an advocate to help them wade through the information and make decisions. Ms. Surlas called it a "disgrace" to keep patients from receiving information from transplant coordinators or other patients who have been transplanted.

Dr. Hunsicker did not mean to imply that the discrepancies in referral rates for kidney transplants are not a problem. But given that the data are good, ACOT needs to move beyond data. Although the reasons for the discrepancy are not clear, more data about access will not be helpful.

When Deborah Rodriguez-Lee was on dialysis, several people in her unit did not know about transplantation, even though the center was in an affluent community. The nephrologists were too busy and the center did not have a full-time social worker to educate patients. All populations, not just minorities, would benefit from an advocate to help them understand their options.

Dr. Evans drew a conceptual distinction between the need and the demand for transplantation. Demand refers to those on the waiting list, but there are always many more who could benefit from transplantation and are not on the list. Fewer than 50 percent of patients who could benefit are on the list for a kidney, for example. For heart transplants, for example, the need ranges from 50,000-60,000 to well over 100,000. The problem is chronic and we cannot meet the demand for this procedure, let alone the need.

Dr. Ascher asked if ACOT members supported the two recommendations of Subcommittee 7, and many responded affirmatively. However, Dr. Kahan argued that more is needed than Recommendation 1. The problem is well established, so remedies, not an evaluation methodology, are needed. But Dr. Ascher argued that the committee wants to understand the reasons for the discrepancies in referral rates, and several ACOT members agreed. Dr. Higgins explained that some other comorbidity may exist, for example, and the data we have may not be accurate. The issue needs to be assessed so that the committee can select an appropriate solution. Education in the dialysis center is one solution, but other needed steps are less clear.

Dr. Kahan suggested that a substantial part of the problem is due to the fact that existing rules and regulations are not enforced. But Dr. Higgins argued that this is not known. Dr. Ascher suggested the following additional recommendation:

3. Reinforce the implementation of existing regulations stipulating that dialysis patients be educated and evaluated by personnel from the transplant center concerning this therapeutic option.

Dr. Williams believes that those on dialysis need an advocate as much as donors. Education is a place to start, but changes are needed in behaviors and culture. Dr. Alveranga suggested that the health education coordinator who speaks to dialysis patients about transplantation should be invested in transplantation and not be paid by the dialysis unit.

Dr. Harmon asked about the practicality of enforcing existing laws. For example, the rule that the transplant surgeon must sign off on 250,000 patients on dialysis is unreasonable. A different way is needed to reach patients.

Dr. Hunsicker interprets the first recommendation as referring to the need for a greater understanding of the discrepancies in referral rates. The recommendation could be modified to refer to the development of a methodology to include clarification of the reasons for the failure to refer. Dr. Hunsicker agreed that the person who provides education to dialysis patients should not be part of the dialysis center.

Ms. Surlas pointed out that the data often address whether patients are wait listed, but not why. When a patient is not wait listed, this does not necessarily mean that the dialysis center did not refer them for evaluation.

Mr. Nathan referred to the data on donation rates showing that Caucasians have higher donation rates than African Americans. However, African Americans represent approximately 12-13 percent of the overall population and 23-24 percent of potential organ donors. Dr. Higgins explained that the data he presented on donation rates use the three statistical methods he mentioned in his presentation. Based on cadaveric donors per million population, whites donate organs 13 percent more frequently than African Americans, 65 percent more frequently based on deaths per 10,000, and 71 percent more frequently based on cadaveric donors per 1,000 evaluable deaths. Blacks have higher rates of evaluable deaths because they die at younger ages.

Partial Report of Subcommittee 1: Kidney and Pancreas Allocation Review
William Harmon, M.D.
Dr. Harmon explained that Subcommittee 1 had summarized its discussions on living donation earlier in the meeting, and he would now report on the allocation of cadaveric kidneys, financial barriers, and access to transplantation.

The subcommittee asked SRTR whether removal of matching at the B locus has an effect on graft survival and sensitization, what the effect is on distribution of grafts if wait time is the predominant determinant, and whether race is still a risk factor for graft survival. If the emphasis on histocompatibility matching were removed, perhaps more African Americans would be transplanted but subsequent graft survival might suffer, raising the need to balance utility and equity.

When matching at the B locus is removed, as has been done by OPTN, the relative risk for graft failure increases by two percent and graft survival decreases by 0.002. This does not appear to be significant. The relative risk for African Americans and others is basically the same, so the removal of B locus matching would not result in racial bias. Removal of matching at the B locus increases sensitization by only one percent for someone receiving a second graft. The subcommittee concluded that this change will not hurt graft survival or sensitization.

SRTR is still evaluating the effect of starting wait time at first dialysis. If certain groups are not being listed when they start dialysis, the subcommittee wondered if it would be fair to start their wait time on the first day of dialysis, even if they are on dialysis for 5-10 years. Although many believe that this is fair, it might decrease graft survival, which is known to diminish in recipients who are on dialysis longer.

At 1 year, graft survival is the same for blacks and whites, but 1-year survival may not be the right measure because 3-year graft survival is consistently higher (by 10 percent) in whites than in blacks. Although the gap in 1-year graft survival has closed, long-term rates are still disparate. Dr. Harmon noted that 3-year graft survival is higher for Hispanics than non-Hispanics. Subcommittee 1 recommended the following:

1. Conduct research into the causes of the disparities in organ transplant rates in underrepresented groups and eliminate these disparities.

Although removal of matching at the B locus will have little deleterious effect on overall graft survival, the balance of matching at the D locus and using wait time as the basis of allocation is unknown. OPTN has made a judgment on a scientific basis that use of wait time may not be sound. OPTN recognizes this and will reexamine and possibly alter this decision. Subcommittee 7 will continue to monitor the balance of equity and utility in the allocation of kidneys for transplantation.

Potential financial barriers to being listed for kidney transplantation have received little analysis. The subcommittee suspected that the removal of Medicare coverage at 20-33 months for immunosuppressants would have a detrimental outcome. However, insufficient data are available to support this theory.

In 1992, the largest group of individuals on the wait list consisted of those who were aged 35-49 years. Over the past 10 years, the numbers of individuals on the list aged 18-34 and 35-49 have increased, but a more dramatic increase occurred in those aged 50-64, who currently represent the largest age group. Also, the rates for individuals aged over 65 years have increased strikingly. Currently, eight times as many individuals over 65 years are wait listed than are children who are under 18 years. Individuals aged 18-34 years are now less likely to receive a cadaveric transplant than in 1992, those aged 35-49 years have approximately the same likelihood, and those over age 50 years have a much greater chance of being transplanted. Both the waiting list and the transplant list are aging.

The risk of graft failure from living donors is substantially less than from cadaveric donors, regardless of race. However, while 44 percent of Caucasians received an organ from a living donor and one-third received a preemptive transplant (without first undergoing dialysis), only 24 percent of African Americans received an organ from a living donor and 17 percent received a preemptive transplant. African Americans are less likely to receive either a cadaveric or a living donor transplant.

African Americans also wait longer, 463 days, for a living donor transplant than Caucasians and other races, who typically wait approximately one year. Graft survival rates are poorer for living donor transplants in blacks than in whites and other races. The subcommittee concluded that African Americans have poorer cadaver graft survival and living donor graft survival, and fewer referrals for cadaver and living donor transplants.

Discussion
Dr. Higgins proposed that the multicultural issues subcommittee and other leaders in the field of kidney transplant talk to CMS about the impact of financial barriers, which requires further analysis. The Secretary has the power to help facilitate such a discussion. Dr. Harmon replied that Subcommittee 7 plans to look more deeply into this in the future. Dr. Higgins suggested a recommendation to the Secretary to facilitate discussions between some ACOT members and CMS. Mr. Kress suggested that a CMS representative participate in the next conference call. Dr. Delmonico suggested that Dr. Higgins bring the results of this discussion back to the entire committee. Dr. Higgins pointed out that Subcommittee 7 should also be involved in this discussion.

Report of Subcommittee 6: Improving Systemic Performance: The Professions
Diana Lugo-Zenner, R.N.
Ms. Lugo-Zenner reported that Subcommittee 6 addressed the development of best practices, the use of benchmarks, and the refinement of existing processes. Best practices are based on the assumption that what one organization does, any other can do as well. Benchmarking allows the comparison of one organization's performance to the best in the industry.

Best practices and benchmarking are needed because approximately 80 percent of donors come from 20 percent of hospitals, donor management practices vary, and the number of donors per million population varies by OPO. OPOs believe that they have the burden of acquiring organs, but the onus is on the entire community, including transplant centers, hospitals, and federal, state, and local government. The bottom line is shared accountability.

Best practices and benchmarks need to be across the board and separate from monitoring/regulating. They should be achievable and offer a qualitative comparison of processes, an annual improvement goal, standardized language/calculations, and collaborative/shared accountability. Funding will be required.

SRTR is attempting to develop a performance indicator other than donors per million. Perhaps an achievable benchmark could be set at 21 donors per million across the board. If this goal is not met, OPOs would have an appeal process. A benchmark should be set for non-heart-beating donors and for standard consent language. There may be a role for the development of donor management algorithms.

Transplant centers must collaborate with OPOs to help promote and enhance donation through health fairs and partnerships with community agencies. Centers should dedicate funds to promoting donation in the communities and populations they serve. Hospitals can also play a role in promoting donation, perhaps through baseline education modules for healthcare workers. Level 1 trauma certification might offer an opportunity to promote donation as a condition of participation. It is not clear that hospitals in general are complying with the conditions of participation.

CMS has been developing performance criteria for OPOs, and this work needs to be communicated to the community. What state and local governments can do to promote donation should be explored. Perhaps educational models could be developed for high schools, colleges, medical school residency programs, as well as other professional programs. "Missed donor referrals" should be considered serious events, similar to sentinel events in the hospital setting. A survey is needed to establish compliance with documentation of referrals.

The subcommittee's recommendations are as follows:

1. Failure to identify a potential organ or tissue donor and/or to refer such a donor to the OPO in a timely fashion should be considered a serious medical error. Such events should be investigated and reviewed by hospitals in a way similar to that for other serious medical errors.

The following should be added to the CMS conditions of participation:

2. Each hospital with more than 100 beds should identify an advocate for organ and tissue donation from within the hospital leadership. Each hospital should establish, in conjunction with their OPO, policies and procedures to manage and maximize organ retrieval from non-heart-beating donors.

3. OPO payment for hospital costs for potential donors may begin prior to donor death when a firm decision has been made to withdraw life support for futility, and when the person is a potential donor.

4. The regulatory framework for transplant center and OPO certification should be based on principles of continuous quality improvement. The regulatory criteria should focus on performance. Failures on measures of performance should trigger quality improvement processes under the aegis of entities other than those responsible for evaluation of performance.

5. Monitoring and evaluation within the regulatory domain are the proper province of the government. The support of quality improvement is the proper province primarily of agencies outside of those government agencies involved in monitoring and evaluation.

Discussion
Mr. Nathan believes that Recommendation 1 is the strongest, because it is imperative that such events not be missed. Ms. Gunderson agreed that missed referrals do result in lives being lost. The recommendation should be strengthened to note that the preferred donation process may not have been followed. Ms. Lugo-Zenner replied that the best practices do not need to be written immediately. At this point, the subcommittee is seeking the entire committee's endorsement of the need to develop some best practices across the continuum.

Ms. Surlas noted that the subcommittee on education and recognition of donors made the same recommendation. Those who audit hospitals do not seem to be aware that they are supposed to check on referral rates. Audits present a golden opportunity to pick up on lost donors.

Mr. Nathan noted that futility of care is becoming a major issue in larger institutions. If a family decides to withdraw care with encouragement from the ICU staff, this is often due to the lack of both financial and personnel resources. If these patients are maintained so that they can become non-heart-beating donors, it will cost money and who will pay for it is not clear. If a patient is maintained because they are a potential donor, neither the hospital nor the family should be burdened with the resulting cost.

Ms. Turrisi noted that OPOs pay back 100 percent of bill charges during this process. With donor management and heart management, the cost of the SAC will go up. Many hospitals have caps on what they can pay for. Over time, continued payment of 100 percent will create its own burden, and a cap is needed. Dr. Ascher pointed out that the 100-percent policy is not in effect everywhere.

Mr. Seely predicted that if the number of donors increases, some costs will go down as a result of volume increases. Non-heart-beating donors do not cost as much, and spend less time in the ICU. Other funding opportunities may exist to increase organ recovery.

Dr. Harmon was concerned about suggesting that all hospitals recover organs from non-heart-beating donors, because public backlash might be significant. Some groups are concerned about whether such individuals are dead before their organs are removed. If the committee makes this recommendation, it must be prepared to support it in the face of backlash. Dr. Hunsicker explained that the subcommittee considered this issue, and decided to stand by the definitive statement made on the issue by the Institute of Medicine (IOM). If the IOM's authority is accepted, hospitals should follow this recommendation.

Phil Berry, M.D., reported that it took his institution 2 years to establish a non-heart-beating program. The difficulty of establishing such programs, given staff reluctance, must be taken into account.

Ms. Cottingham-Streater supports Recommendation 3, but suggested that the word "futility" gives the impression that the focus is on resources, which might support existing concerns that such patients do not receive the care that is warranted under the circumstances. Ms. Lugo-Zenner agreed that this wording needs to be changed.

Dr. Delmonico has also experienced difficulty in establishing non-heart-beating donor programs. Hospital administrations are concerned about liability and whether the individual is actually dead. But this committee should support such donations. It might be prudent to state that hospitals must ensure that the potential donor is dead.

Ms. Palumbi believes it imperative that those doing the monitoring and evaluation not be involved in the donation process. Mr. Seely noted that the intent is to move from a punitive system to one that brings organizations into collaboration.

Partial Report of Subcommittee 3: Liver Allocation Review
Larry Hunsicker, M.D.
Recommendations:

1. Background: HLA typing of all organ recipients is currently required by various national standards but is not currently the accepted practice for liver transplant recipients or for living liver donors. Recommendation: The requirements for HLA typing of liver transplant recipients or living liver donors should be deleted. This testing may, however, be appropriate for some donors and recipients and should be compensated for when specifically ordered, as for all other appropriate laboratory tests.

2. Background: Currently, preference is given to prior living kidney (only) donors in the receipt of a future kidney transplant, should it be required. Recommendation: That the preference given to prior living kidney (only) donors be extended such that any living organ donor would be given preference for the receipt of any organ transplant, should one become needed.

OPTN has already changed the rules regarding the priority given to patients with hepatocellular cancer in a way that is consistent with the beliefs of Subcommittee 3. The subcommittee will evaluate and discuss whether tumor-doubling time should be incorporated into this issue.

A single cadaver donor liver can be split into two halves for transplantation into two recipients, although this is a major undertaking. The subcommittee encouraged the splitting of appropriate livers and the protection of centers that use splits. SRTR analyzed the impact of using split livers on outcomes and found no significant evidence of an effect, although the number of cases may not be sufficient to yield the needed power. Centers that are uncomfortable with the procedure should not be required to offer it, as this would not be good medicine. But any center that uses split livers should be protected from the charge that it did the wrong thing in the event of a bad outcome. If a policy were established, it could prevent lawsuits. This needs to be discussed more with OPTN.

Efficiency and justice/equity are two criteria for the liver allocation scheme. The community has chosen to use MELD/Pediatric End-Stage Liver Disease (PELD) scores as a measure of utility. Indicators that a condition is so severe that it is no longer reasonable to transplant the patient might not be limited to MELD/PELD, but they might include these systems. The subcommittee lacks sufficient data to make recommendations on these issues, but any recommendations made would be done in conjunction with the OPTN committee. Mortality is associated with liver transplants, so if someone is more likely to be alive without a transplant, they probably should not be listed, but more data are needed.

The subcommittee also considered an issue that was transferred from the professions subcommittee, which is whether efficiency could be increased by sharing organs across regions. A high percentage of livers are transplanted with MELD scores below 20 in some areas while in other areas, patients die with MELD scores greater than 20. The committee needs more information to make recommendations.

Discussion
Ms. Solarz would like to see data about MELD/PELD and regional variation. New York State has used regional sharing for several years. The reasons why death rates are so high for people who are so sick and not receiving livers in a timely way need to be understood. Dr. Ascher stated that ACOT will explore this further.

Dr. Marcos distinguished between splitting livers for one child and one adult, versus for two adults, which are completely different procedures. The first has proven results, but the effect of the second is not clear because so few cases have occurred.

ACOT members endorsed the recommendations of Subcommittee 3.

Report of Subcommittee 4: Education and Recognition of Donors
Arlene Locicero
Ms. Locicero reported that Subcommittee 4 supports core curriculum standards in states for public education to teach children and their families about organ and tissue donation. Education should go beyond the public sector K-12 to other educational programs, such as in nursing, for which continuing education units are required.

The subcommittee also addressed donor incentives and the need for a consistent national message. The subcommittee is concerned about end-of-life issues and would like to know how successful OPOs handle their programs, especially the successes of hospitals.

Recommendations:

1. The Secretary should support the Surgeon General's certificate of appreciation of donors to be given to the transplant community to distribute, perhaps through OPOs, and ultimately given to each donor or donor family.

2. The Secretary should insist that the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) adhere to its own requirement in assessing hospitals with regard to referral to OPOs upon the impending death of patients. Should hospitals not be in compliance, appropriate reprimands, probations, or penalties should be imposed. Donor review should become an integral part of this evaluation.

3. The Secretary of HHS, in concert with the Secretary of Education, should recommend to states that the subject of organ and tissue donation be included in core curriculum standards for public education as well as in curricula of schools of education, and other professional schools.

4. There should continue to be a coordinated effort to promote organ donation awareness.

Discussion
Mr. Kress clarified that the Surgeon General works for the Secretary and that the Secretary already supports his efforts. But the subcommittee was not sure that the certificates have been distributed in a consistent manner. Dr. Shanteau added that the certificate program is a good form of donor recognition and the Secretary might want to add his signature or stamp of approval to the certificates.

A representative of the Division of Transplantation clarified that two versions of the certificate are available for living and deceased donors. They are offered by the division to all OPOs for distribution to donors, but some OPOs may choose not to use them. However, the division does not know how many certificates are awarded because OPOs do not report these figures.

Mr. Nathan pointed out that JCAHO is a private organization that conducts inspections on behalf of Medicare. Dr. Berry suggested that knowing that a JCAHO inspection is coming makes hospitals very concerned about whether they will pass inspection, because their survival depends on meeting the requirements. But JCAHO does not ask about organ referral, even though its regulations require such questions. Hospitals will respond if such questions are asked because if their answer is not satisfactory, they will be placed on probation until their program is in order. This is where organs are falling through the cracks.

Mr. Kress pointed out that the ultimate set of ACOT recommendations will be from ACOT as a whole and not from specific subcommittees. He and Dr. Ascher will therefore try to combine similar recommendations from different subcommittees, and coordinate them through the e-mail process.

Ms. Locicero noted that when core curriculum standards are in place, teachers must abide by them. In Ms. Gunderson's experience, educating at the high school level is very effective for changing long-term behaviors. But she wondered if it is realistic to impose such a standard on states. Ms. Locicero replied that teachers' knowledge about donation is not great enough to implement effective core curriculum standards. But if the Secretary of HHS, in conjunction with the Secretary of the Department of Education, made this recommendation, it would have much more power to ensure that donation issues are included in states' core curriculum standards. Ms. Coolican suggested that donation be addressed in the context of death and dying, as several curricula exist on this topic.

Dr. Shanteau reported that the subcommittee was sensitive to the possibility that teachers might not be prepared to present these materials, which is why this recommendation supports the preparation of teachers to use the proposed standards.

Public Comment
Paul M. Schwab, Executive Director of the Association of Organ Procurement Organizations, noted that the data presented by the multicultural subcommittee in May showed that actual approach rates in hospitals and referral rates varied by race and ethnicity. This speaks more to institutional than public behavior. When referral and approach rates are lower, the hospital, OPO, or both are not approaching families because they may assume, out of an unconscious racism, that these families would not donate. This area merits some attention and speaks to the involvement of health professionals in organ availability across multicultural groups. Dr. Higgins replied that the subcommittee would look at this and needs more information on how best to approach minorities. Dr. Alveranga pointed out that while conversion rates are lower for minorities, donation rates are not lower.

Eileen Meier of the North American Transplant Coordinators Organization referred to the apparent lack of transplant coordinators from minority groups. ACOT should consider the need for individuals from minority groups to approach potential donors. Also, the materials available are in English, which presents a barrier for many groups. The nursing shortage also has an impact on minority conversion rates, as insufficient critical care nurses are available to provide accurate information to potential donor families. Ms. Meier supported the education of professionals in hospitals, including nurses, because not all health professionals have accurate information.

Dr. Shanteau noted that several of the ACOT recommendations assume that staffing will be available to carry them out. But staffing is in great shortage, and this should be recognized because suggestions on how to improve care will not be successful if people and other resources are not available.

Richard Laeng, of HRSA's Division of Transplantation, suggested that one way to approach potential donors is to tie in some disease prevention/health promotion issues with organ donation and transplantation. Many diseases that lead to end-stage organ failure are issues in which everyone is interested. The Secretary has several other initiatives in these areas that could lend themselves to teaching about the need for people to take care of themselves and reduce the demand for organs in general. Mr. Laeng asked ACOT to consider this possibility. Ms. Locicero noted that health and physical education classes are increasingly addressing those diseases to which young people are or could be prone. Ms. Surlas added that this message needs to be communicated through television commercials and other media to which the public is exposed. The messages should focus on the lifestyle changes that may prevent the need for an organ that might not be available when an individual needs it.

Concluding Remarks
Dr. Ascher thanked the committee for its hard work at this meeting. Mr. Kress added his thanks, and noted that he would be following up with e-mail drafts of the recommendations so that ACOT members could establish a set of consensus recommendations.

Advisory Committee on Organ Transplantation (ACOT) Members at the Meeting
Gail Agrawal, J.D., M.P.H., University of North Carolina School of Law
Denise Y. Alveranga, M.D., LifeLink Transplant Institute
Nancy Ascher, M.D., Ph.D., Chair of ACOT, University of California, San Francisco
Phil Berry, M.D., Southwest Transplant Alliance
Robert P. Charrow, J.D., Greenberg Traurig, LLP
Margaret B. Coolican, LifeChoice Donor Services
Paige L. Cottingham-Streater, J.D., Mansfield Center for Public Affairs
Catherine C. Crone, M.D., Inova Fairfax Hospital
Francis L. Delmonico, M.D., Massachusetts General Hospital
Roger Evans, Ph.D., Rochester, MN
Robert D. Gibbons, Ph.D., University of Illinois, Chicago
Bartley P. Griffith, M.D., University of Maryland
Susan Gunderson, LifeSource OPO
Larry Hagman, Liver Recipient
William Harmon, M.D., Children's Hospital, Boston
Robert S.D. Higgins, M.D., Virginia Commonwealth University
Lawrence G. Hunsicker, M.D., University of Iowa
Son-Ja Robet Jones, Kidney-Pancreas Recipient
Barry D. Kahan, M.D., Ph.D., University of Texas Medical School
Arlene J. Locicero, Donor Mother, Transplant Speakers International, Inc.
Diana Lugo-Zenner, R.N., M.B.A., St. Vincent Medical Center
Roger R. Luna, Edinburg Regional Medical Center
Amadeo Marcos, M.D., University of Pittsburgh Medical Center
Howard Nathan, Gift of Life Donor Program
Mary Ann Palumbi, R.N., Allegheny General Hospital
James D. Perkins, M.D., University of Washington
Deborah M. Rodriguez-Lee, LifeQuest Organ Recovery Services
J. Thomas Rosenthal, M.D., University of California, Los Angeles
Michael S. Seely, Pacific Northwest Transplant Bank
James Shanteau, Ph.D., Kansas State University
Flora Solarz, M.P.S., NYC Health and Hospitals Corporation
Hans W. Sollinger, M.D., Ph.D., University of Wisconsin
Donald M. Stablein, Ph.D., EMMES Corporation
Deborah C. Surlas, R.N., Kidney-Pancreas Recipient
Katherine L. Turrisi, R.N., M.S.N., Medical University of South Carolina
Michael A. Williams, M.D., Johns Hopkins University
Carlton J. Young, M.D., University of Alabama, Birmingham

Department of Health and Human Services (HHS) Participants
Elizabeth M. Duke, Ph.D., Administrator, Health Resources and Services Administration (HRSA)
Jack Kress, Executive Director, ACOT
Richard Laeng, Division of Transplantation, HRSA
Emily Marcus Levine, J.D., Office of the General Counsel, HHS, HRSA Branch
Joyce Somsak, Acting Director, Division of Transplantation, HRSA

Other Speakers
David Conti, M.D., Professor of Surgery, Albany Medical Center; Chair, New York State Committee on Quality Improvement in Living Liver Donation

Public Commenters
Rhonda Boone
Eileen Meier, North American Transplant Coordinators Organization
Wayne Meyer
David Olson
Nancy Scheper-Hughes, Director, Organs Watch
Paul M. Schwab, Executive Director, Association of Organ Procurement Organizations
Pam Skarda, Transplant Recipients International Organization
Kimberly Tracy

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