Appendix B

IOM and National Academies Solid Organ Transplantation Reports

The Institute of Medicine (IOM) and the National Academies of Sciences, Engineering, and Medicine (the National Academies) published several reports addressing solid donor organ recovery and transplantation. This section provides an overview of the key findings and recommendations included in those reports that are most relevant to the current study.

NON–HEART-BEATING ORGAN TRANSPLANTATION: MEDICAL AND ETHICAL ISSUES IN PROCUREMENT

In 1997, amid efforts to broaden the pool of organ donors, the U.S. Department of Health and Human Services (HHS) requested a report expressing concern about the limited supply of organs for transplantation into patients with terminal organ failure (IOM, 1997). HHS raised questions as to whether (1) interventions undertaken prior to declaration of death might prevent damage to potential donor organs, and (2) interventions to improve organ quality and supply may also hasten the death of potential donor patients. The report recommended that IOM should consider approaches to organ supply interventions that maximize the availability of organs without violating ethical norms regarding the rights or welfare of potential donors. This guidance was issued at a time when there was great interest in expanding donation after circulatory determination of death (DCDD) solid organ donation (IOM, 1997).

NON–HEART-BEATING ORGAN TRANSPLANTATION: PRACTICE AND PROTOCOLS

A follow-up report published in 2000 focused on developing consensus and consistency for non–heart-beating donation practices and protocols (IOM, 2000). It was intended to help improve organ transplant system integrity and sustain public support for and interest

in organ donation (IOM, 2000). The committee clarified non–heart-beating donor (NHBD) donation practices, reviewed similarities and differences among donor protocols, developed and implemented protocols, and reviewed impediments to developing consensus on NHBD organ donation practices. This report and its preceding 1997 reports are critical in the consideration of DCDD, especially as greater focus continues to be placed upon DCDD to increase the availability of organs without compromising procured donor organ performance quality.

ORGAN PROCUREMENT AND TRANSPLANTATION: ASSESSING CURRENT POLICIES AND THE POTENTIAL EFFECT OF THE HHS FINAL RULE

In 1999, IOM convened the Committee on Organ Procurement and Transplantation Policy to review HHS’ Final Rule, which proposed to (1) make changes to the organ allocation system, (2) correct apparent geographic disparities in the amount of time individuals waited for an organ, and (3) ensure equitable access for minorities¹ and the economically disadvantaged (IOM, 1999). At the time, transplant centers and organ procurement organizations (OPOs) had varying policies—official and unofficial—regarding priority assignment and waiting list access for these patients, and the committee recommended the removal of waiting time as a determinant of waiting list priority. The committee found that the major factors producing geographic disparity in transplantation were the size of the population served by the OPO and the volume of patients transplanted, leading to their key recommendation that organ allocation for livers be based on broader sharing of organs within regions consisting of a minimum of 9 million people. HHS immediately adopted the committee’s recommendations, but the implementation of these recommendations was stifled by political factors and the replacement of the head of HHS.

Six years later, the Scientific Advisory Board of HHS found that under the local system, patients were being transplanted with Model for End-Stage Liver Disease (MELD) scores that led to decreased posttransplant survival relative to what they would have experienced by remaining on the waiting list. This revealed that when limited to small geographic areas (e.g., OPOs), improved risk stratification can still lead to inefficient allocation. OPOs with small and medium volume (i.e., less than 75 transplants per service area per year) were significantly more likely to transplant less severely ill patients (status 2B and 3) than OPOs that averaged more than 75 transplants per year. Based on these findings, broader regional sharing of livers was adopted at various MELD score thresholds.

ORGAN DONATION: OPPORTUNITIES FOR ACTION

In 2006, IOM published a report focusing on opportunities for action to improve quality, coordination, and reliability among the multiple organizations and systems involved in organ donation, thus addressing the gap between supply and demand of transplantable organs (IOM, 2006). Further, the report considered the potential for broader policies and practices to reduce the gap in organ donation: for instance, by bolstering preventive health efforts to reduce the need for transplantation; by ensuring equitable access to transplantation by negating current financial and insurance constraints; and by providing ongoing access

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¹ The report noted that while African Americans had equal likelihood of receiving a liver transplant once listed, this group was less likely to be referred for evaluation and placed on the waiting list than white patients.

to immunosuppressive medications to ensure that each donated organ is used in an optimal care environment that includes proper follow-up.

The report recommended the development of improved systems to support organ donation and the implementation of mandates to develop continuous quality improvement initiatives for OPOs and organ transplant centers. However, the report also cautioned against the undesirable consequences of interventions when evaluating perspectives and principles of opportunities for action in the organ donation process. For example, implementing policies in only a few select states may result in adverse negative spillover effects on public attitudes, potentially eroding public support for organ donation—negative perceptions may be very difficult, if not impossible, to reverse. The report also examined the use of financial incentives (i.e., cash payments or tax deductions) and preferential access to health care for donors and potential donors to see if they would provide additional increases in the rates of organ donations; ultimately, hard data on this concept are lacking and may need further research. However, the report did recommend that the use of financial incentives to increase organ transplants should not be promoted at the time of its writing. Finally, the report strongly recommended redoubling efforts to encourage and reduce barriers to live donor organ donation.

OPPORTUNITIES FOR ORGAN DONOR INTERVENTION RESEARCH: SAVING LIVES BY IMPROVING THE QUALITY AND QUANTITY OF ORGANS FOR TRANSPLANTATION

In 2017, the National Academies of Sciences, Engineering, and Medicine published a report on organ donor intervention research as a potential way to improve the quality and increase the number of transplantable organs, including organs that might be otherwise discarded that focused on solid organ transplantation (NASEM, 2017). To this end, it emphasized the need to

• Improve transparency and public trust in the donation process for research followed by transplantation.
• Improve coordination and information sharing of donor preferences.
• Clarify legal guidance on organ donation.
• Promote informed consent for organ recipients in organ donor intervention research.
• Establish centralized management and oversight of organ donor intervention research to ensure equitable, transparent, and high-quality research.
• Promote transparency on organ donor intervention research (NASEM, 2017).

It recommended that the Organ Procurement and Transplantation Network, OPOs, the Health Resources and Services Administration, advocacy organizations, and professional associations explore, develop, test, and implement communication strategies that effectively explain organ donor intervention research. Moreover, the report called for improved coordination and sharing of information about donor and potential recipient preferences regarding research on organ donors and donor organs procured.

REFERENCES