The Evolution and Direction of OPTN Oversight of Live Organ Donation and Transplantation in the United States

Abstract

For more than 20 years, the Organ Procurement and Transplantation Network (OPTN) has developed policies and bylaws relating to equitable allocation of deceased donor organs for transplantation. United Network for Organ Sharing (UNOS) operates the OPTN under contract with the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services (HHS). Until recent years, the OPTN had little defined authority regarding living donor organ for transplantation except for the collection of data relating to living donor transplants.

Beginning with the implementation of the OPTN Final Rule in 2000, and continuing with more recent announcements, the OPTN's role in living donation has grown. Its responsibilities now include monitoring of living donor outcomes, promoting equity in nondirected living donor transplantation and ensuring that transplant programs have expertise and established protocols to promote the safety of living donors and recipients. The purpose of this article is to describe the evolving mandates for the OPTN in living donation, as well as the network's recent activities and ongoing efforts.

NOTA and the OPTN Final Rule

The OPTN's role as defined by the National Organ Transplant Act of 1984 (1) (NOTA) did not address living donation in any significant way. NOTA's primary objective was to establish an equitable system to allocate organs from deceased donors and to create a scientific registry to monitor transplant recipient data. At the time of NOTA's enactment, and for roughly a decade afterward, the overwhelming majority of living donors were blood relatives of the recipient having a high immunologic match. This extensive practice of live kidney donation, subsequently developed in US transplant centers, mostly dependent upon local oversight of the process for quality and safety measures. The OPTN Final Rule, published in 1999, established the OPTN's authority under federal regulation. Like NOTA, the Final Rule did not specifically define a role for the OPTN in living donation. But it established certain precedents for later involvement. It charged the OPTN with developing policies for equitable allocation of deceased donor organs. It further noted that the OPTN would develop policies on ‘such other matters as the [HHS] Secretary directs’. In addition, the rule placed considerable emphasis on the OPTN's role in ensuring public health and patients' safety through membership standards and review of policy compliance (2).

Recent Developments and HRSA Mandate

In the early and mid-1990s, several trends in living donation began to emerge:

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  Studies demonstrated that long-term graft survival from living donor transplants, even with significant histocompatibility antigen mismatching, tended to equal or exceed graft survival from optimally matched deceased donor transplants.
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  As waiting time to receive an organ from a deceased donor continued to lengthen, increased numbers of people volunteered to be living donors to meet the needs of an individual candidate. In many instances, these potential donors were not familial relatives of the intended candidate but had some emotional relationship, such as family friends, coworkers or members of the same religious, civic, or fraternal organization.
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  More living liver and lung donor transplants were performed, both of which entail a greater potential for significant donor complications than kidney transplants.
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  Living donor exchange protocols were being developed, including paired living donation and living donation in exchange for greater allocation priority for a designated recipient on the deceased organ waiting list.
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  Reports of isolated living donor deaths and significant complications focused public attention on safeguards for the donor's health.
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  As the Internet has grown as a major communication tool for the general public, some potential candidates and donors with no prior relationship have made online arrangements for living donation. Public solicitation has raised questions regarding of ethical propriety, equity of access and potential illegal financial relationships in solicited live organ donation.

The cumulative effect of these trends has created changes in the demographic and clinical characteristics of living donors as well as their motivations and expectations for donation. As a result, greater public scrutiny is placed on the transplant field to ensure that potential living donors are thoroughly evaluated, that they receive appropriate information, can provide informed consent to donate and that they are sufficiently monitored for complications not only perioperatively but also in the long term (3).

Reflecting on these considerations, HRSA began to examine what role the OPTN should have in the area of living donation. In a statement published in the Federal Register June 16, 2006, HRSA determined that OPTN policies addressing issues of living donor safety and equitable allocation of living donor organs will have the same enforceability as deceased donor policies under the OPTN Final Rule. The emphasis of living donor guidelines and policies, expressed in the Federal Register notice, should be ‘to promote the safety and efficacy of living donor transplantation for the donor and recipient’.

Medicare Conditions of Participation

Separate conditions of participation issued by the Centers for Medicare and Medicaid Services (CMS) mandate that any hospital with a transplant program and any organ procurement organization involved in living donation must submit required data to the OPTN in a timely manner regarding organ donors (living or deceased), transplant candidates and transplant recipients. Failure to submit required information could result in penalties up to exclusion of Medicare funding for the organization.

In March 2007, CMS issued, for the first time, specific Conditions of Participation (CoP) for transplant centers. In the announcement of these CoPs, CMS asserted its responsibility to establish ‘minimum standards to protect patient health and safety, and for implementing oversight mechanisms' (4). Among the provisions relating to living donor transplantation, the CoPs require transplant programs to have an established protocol for medical evaluation of living donors and to have an independent donor advocate or advocate team to focus on the interest of the potential donor.

OPTN Actions Relating to Living Donor Transplantation

Given the direction provided by HRSA in its June 2006 announcement, the OPTN has actively worked to broaden available follow-up data on living donors, develop minimum standards for programs performing living donor transplants and provide resource information for the benefit of both the transplant community and the potential living donor. The OPTN also seeks to maintain consistency with requirements established in the Medicare conditions of participation.

Since 1999, the OPTN has required submission of living donor follow-up data for one year postdonation. Yet as attention has focused on potential longer term complications arising from living donation, it is desirable to extend the period of data collection. Acting on a contractual requirement from HRSA, the OPTN/UNOS Board of Directors voted in June 2007 to extend the period of living donor follow-up reporting to 2 years from the donation event. The revised follow-up form also encourages the transplant program to provide more specific information than ‘Lost to follow-up’, a response frequently submitted in the past. Additionally, in response to growing concerns about living donor safety and the role of the OPTN in oversight of this area, the OPTN/UNOS Board of Directors made reporting of the death of a living donor or native organ failure after organ donation mandatory for all members. The Membership and Professional Standards Committee (MPSC) has been charged to use the peer review process to review and assess adverse donor events in monitoring overall safety of the performance of live donor transplantation. A limitation of this system is that self- (and/or media) reporting is required for identification of these events and is a potential shortfall.

However, the major responsibility for oversight of live organ donation under the authority given by HRSA in 2006 requires clear bylaws and policies to address national concerns. The OPTN/UNOS Living Donor Committee began to define the resources and necessary processes required of OPTN members to perform live organ donation. In September 2007, the OPTN/UNOS Board approved new bylaws for member transplant centers that operate kidney and/or liver programs involving living donor transplants. The bylaws require programs performing living donor transplantation to identify the institutional resources necessary to provide thorough medical and psychosocial evaluation, and to have written protocols addressing the phases of the living donor process, including 2 years of living donor follow-up reporting, and to abide by those protocols once established. The member program must also have an informed consent process that will facilitate a noncoerced, autonomous donation with full awareness of the risks, benefits, and alternatives as well as the outcomes at both the individual transplant center and nationally. In addition, these bylaws require member programs to have a knowledgeable person (independent donor advocate or IDA) who is independent from the medical professionals directly involved in the care of the potential transplant recipient, to serve as an advocate for the needs and interests of the potential living donor.

UNOS had previously established voluntary standards for liver transplant programs performing living donor transplants. Programs that had been approved under the prior UNOS standards will need to supply some additional information, but not submit a completely new application, to meet new criteria in the OPTN bylaws. All kidney programs performing living donor transplants, and any liver program that wishes to do living donor transplants in the future, will need to submit a new application.

Also at its September 2007 meeting, the OPTN/UNOS Board approved a resource document to describe commonalities of transplant programs' protocols for ensuring informed consent for living organ donation. The resource document can help inform potential donors in a consistent way about the risks and benefits of living donation, and can be useful for transplant programs to serve as a template and guide as they assess and revise their individual protocols.

The OPTN/UNOS Living Donor Committee developed a resource document stemming from the proceedings of the Amsterdam and Vancouver consensus conferences on responsibilities to the live organ donor (5–8), prior consensus statement on live organ donation (9) and practices identified in a survey of protocols from programs performing living donor transplants. This resource addresses elements of educating potential living donors about the donation process, explaining donor risk and benefits, some of the elements necessary for informed consent, and arranging for follow-up evaluation after the donation. It has been posted as an informational resource on the OPTN, UNOS and Transplant Living^SM web sites and distributed via electronic-mail to medical and program staff at programs performing living donor transplants.

A second resource, addressing the medical and psychosocial evaluation of potential living donors, was approved in June 2008. The OPTN/UNOS Living Donor Committee had initially sought public comment on this document in July 2007. However, the resultant feedback varied widely, including strong reservations from many transplant professionals was that the original proposal was too prescriptive upon medical practice. The OPTN/UNOS Living Donor Committee, professional societies and the UNOS Board over the ensuing months incorporated a number of modifications to the original proposal. Ultimately the Board approved the modified resource document with the caveat that specific content should be re-evaluated on a regular basis by the Living Donor Committee, to ensure that it reflected changes in medical practice. The Living Donor Committee was also charged with developing a parallel document aimed at the lay public in order to educate and inform potential living donors and their families.

Future Direction

Living donation will continue to be a central part of organ transplantation, due to increasing volumes and increasing need to address the shortage of transplantable organs. It will continue to be an area of emphasis for the OPTN, as well as federal agencies including HRSA and CMS. It will be necessary that metrics be created in order to monitor the overall performance of donation at both the system and center levels. The elements that are chosen should be done with the input, concurrence, and support of the members and the public.

Living donation is unique in having the potential to both harm and benefit the volunteer donor. For this reason, the OPTN is committed to learning more about the short and long-term risks assumed by the live organ donor and to maintain system-wide standards that create the broadest possible access for living donation with the least potential harm.

The OPTN's responsibility to oversee live organ donation is a new charge. There will likely be areas of friction as some members feel that there is too much intrusion and oversight of an area that has worked well for decades. Future efforts will depend on the consensus of the transplant community, including the growing participation of people who have personal experience with living donation. Areas of emphasis will likely include more in-depth analyses of donor risks and outcomes and more focused recommendations on data to be collected, as well as additional recommendations to help living donor transplant programs effectively screen potential donors and manage their treatment throughout the donation process. It is essential to get the system performance metrics correct, so that paired kidney donation and other novel methods to increase living donation that may help ameliorate the need for more organs will have a predictable, reliable and trustworthy system in which to be implemented.

The bylaws and resource documents mentioned in this manuscript were created through the processes of the OPTN/UNOS. The authors' leadership roles and professional interest in the content and process could be construed as a conflict of interest, but it should be noted that each resource document and bylaws were vetted, modified and approved through public comment, committee(s) assessment and the OPTN/UNOS Board of Directors' review and approval. The end product is not so much the individual perspectives of the authors as a compromise document that reflects the sentiment of the majority of OPTN/UNOS members. As with all compromises, unanimity on all elements rarely exists. Future modification of the living donor policy, bylaws or resource documents will result from unrecognized deficiencies in the existing language and efforts from the transplant community to correct them. These will be coordinated by the OPTN/UNOS leadership of that generation.

Conflict of Interest Statement

The authors represent the OPTN/UNOS committee chairs involved with living donation (RSB), policy oversight (RH) and the OPTN/UNOS President (TLP). These committees served as the origin of the bylaws and resource documents. RH and TLP were elected by the transplant community in their roles and RSB was appointed as chair of the live donor committee. All authors served voluntarily, received no compensation and have no financial interests to disclose.