Chairman Wyden and Ranking Member Crapo,

Thank you for this opportunity to respond to the issues raised during the August 3, 2022 presentation concerning the United States’ Organ Procurement and Transplantation Network before the Senate Finance Committee. Our organization, Science in Donation and Transplant (SID&T), shares the commitment of the physicians, patient advocates and donation professionals who labor daily to make the miracle of transplant work. This commitment includes the study of ways to improve the nation’s system of altruistic organ donation and transplant, a system which is, already and without question, the best opt-in system in the world. SID&T understands that the foundation of a system based on altruism is public trust. We are concerned that certain actions of the Senate Finance Committee, and the process of one-sided vituperative attack, risks damaging this trust, and that this attack is not designed to further the goals of system improvement, but rather engenders mistrust and threatens the peer-reviewed scientific evidence based quality-enhancing processes.

Congress recently charged the National Academies of Sciences, Engineering, and Medicine (NASEM) to examine and recommend improvements to research, policies, and activities related to deceased donor organ procurement, allocation, and distribution. [1] The congressional language requested that the report include recommendations to update the Organ Procurement and Transplantation Network’s (OPTN’s) policies and processes. NASEM took up this challenge and issued its report earlier this year, making targeted recommendations for further study, not only of the OPTN, but of the OPOs and transplant centers and physicians that make the miracle of transplant a reality. The Senate Finance Committee hearing, the report for which was drafted before the hearing was even held, added nothing to the worthwhile and serious project of NASEM to save more lives, more equitably. Instead, it damaged efforts to ascertain quality in an irresponsible effort to diminish the public’s trust in a system, which while imperfect, is in need of support, not constant, privately orchestrated attack. If there was an interest served by this hearing, it was not the public’s interest, or the interest of even a single patient on the waiting list.

The purpose of the “hearing” (which to be fair was more of a public flogging), was for Chairman Wyden and Senator Grassley to voice their concerns about the government contractor serving as the nations’ Organ Procurement and Transplantation Network (OPTN). United Network for Organ Sharing (“UNOS”) is the private nonprofit entity that has been designated to serve as the Network for the last thirty-eight years. Federal oversight of UNOS’ organ transplant policies is conducted by the Health Resources and Services Administration (“HRSA”), an agency within HHS (see 42 U.S.C. § 274c). The “hearing”, apparently intended as an expose of gross failures, instead demonstrated the wisdom of Congress in 1984 when it put the complex issues of organ donation and transplantation policy in the hands of a non-profit representative member organization, made up of experts, and not into the political sphere.

Experts in healthcare, such as peer-selected UNOS leadership know how to review, evaluate, and assess factual claims. They also know how to utilize data on frequency, severity and trends. Most importantly, they know how to conduct reviews of facts in a manner best calculated to obtain those facts, design better outcomes, and protect the confidentiality of the patients involved. The Senate Finance Committee’s process and report flouted all of these standards and practices, decimating its own statutory construct for a peer review system in order to spew a few out-of-context sound bites designed not to improve quality, but presumably to score media headline points. Having already gnawed one leg of the table, by flogging the network of non-profit OPOs, the second leg has now been chewed to a nub. According to the Committee, the next leg will be the Executive Branch. We will see if transplant centers and hospitals, as the fourth leg, will also be cut off, leaving no institution left for the public to rely on to ethically obtain organs from the altruistic deceased and their families, and equitably share them nationally. The only solution proposed to correct the “failures” of the world’s most successful system seems to be closure and de facto replacement by new, preferably technology-based entities, and the entry of large for-profits into Americans’ most intimate moments.

While there are real problems to be addressed, by serious and knowledgeable policy makers, the Senate Finance Committee seems to prefer overlooking the remarkably few errors over several years, the significant gains in organ donation and transplant, and ways for improving the existing donor transplant infrastructure. The report on which the hearing was based was released to the press, the non-UNOS participants and others prior to the hearing, but was withheld from UNOS, its membership, and the public until after the spectacle, eliminating any opportunity to correct errors, provide context or correct misleading contents. This process underscored the nature of the hearing as an effort to sling mud, rather than to gather or examine facts.

Rather than discuss the recommendations of the Congressionally mandated and financed NASEM report, including the need for a lengthy and fact-based examination of the OPTN’s IT capability, the Senate Finance Committee instead shared stories concerning medical errors investigated by UNOS, without context, comparison or recommendation about how another, different process would have changed any of the incidents. While SID&T believes that any error is too many, we support the process of peer review and corrective action that is the bedrock of all healthcare quality efforts. UNOS' role is not to “close poor performers”, but rather to investigate and remediate the causes of errors, in order to prevent them. While UNOS can recommend to HRSA that action be taken against an OPO or transplant center, its statutory role is not primarily punitive, but rather policy-making and prophylactic. Public stoning, like the Senate Finance Committee meeting, has never fixed a process error. By punitively revealing materials that were openly shared in a peer review process, and sharing more than the minimum necessary facts about these materials, Congress undermines the peer review process created by the National Organ Transplant Act created; a process that has saved more lives than any other nation’s donation and transplant system.

The OPTN is a membership organization that was established to be “operated by the transplant community [...] with oversight by HHS.” It is governed by a Board of Directors that is made up of representatives from transplant centers, physicians, organ candidates, donors, and recipients, along with organ procurement organizations (“OPOs”), voluntary health associations, and members of the general public. Members include OPOs, transplant hospitals, and other institutions or individuals with an interest in organ donation. Each of the witnesses paraded before the Finance Committee admitted to being UNOS members, and each of them was unquestionably granted an equal voice in policy decisions and processes. What the Committee failed to share with the public is that most of the individuals testifying are also engaged in litigation against UNOS, due to policy disagreements between their private hospitals, and UNOS’ representative members. [2]

SID&T does not have a comment on the wisdom or equity of the policy position that UNOS’ membership and HRSA approved, a policy determination that has thus far been sanctioned by the courts, but we note that presenting members engaged in active litigation against the nation’s plan to equitably allocate organs as being representative of the transplant community as a whole was at least disingenuous, and could be seen as disqualifying in any real “hearing”. These witnesses had conflicts of interest that, at least, needed to be disclosed.

The risks of political actors engaging themselves in issues of complex policy and healthcare systems without objective guidance were on full display during the hearing. For example:

1. Although UNOS, a private non-profit entity, is currently the contract holder for the nation’s OPTN system, they will presumably be in a competitive bidding posture against other private entities in the near future. This hearing taints the process of public contracting by injecting political pressure into what should be a fair bidding process based on legal processes and measurable deliverables.

2. The Committee spouted facts and figures without context or analysis, as though numbers have an independent magical meaning. When discussing healthcare outcomes, stating that 70 deaths occurred is profoundly misleading without the context of the number of successful transplants over those seven years, which in this case is over 230,000. It is also meaningless without the context of medical error rates in general. [3] Any health care outcomes reviewer would acknowledge that the numbers compare extremely favorably to overall death rates due to medical error (0.03% for deaths due to donation and transplant system errors, compared to 9.5% for medical error rates overall). If the point of the hearing was fact-finding, or general concern, as opposed to lobbying for a new private contractor, this point would have been shared.

3. The Senators, both in the report and in Committee, devoted much time to stating that of the complaints submitted, too few were forwarded to HRSA for decertification. Again, this presumes that referral for decertification is the best or most appropriate response to a complaint, rather than review, investigation, peer review, root cause analysis and monitored effective corrective action. It also assumes that all complaints are within UNOS’ scope of action, and meritorious. Again, without context, such facts are meaningless, worth less than anecdotes. Health care quality does not arise from the recounting of stories, it arises from close analysis of the cause of mishaps, and full-throated participation from the professionals involved, including doctors, nurses, OPO professionals and others. UNOS promises that those who participate in fact-sharing will be protected, because this is how quality is done in America.

Perhaps the worst thing accomplished by the Senate Finance Committee in its presentation was the assault on health care quality by its unnecessary violation of basic tenets of peer review and quality. The Senate requested, and eventually obtained, the peer review privileged material entrusted to UNOS under federal law. In managing the OPTN, UNOS has established a Membership and Professional Standards Committee (MPSC) that, among other things, conducts quality assurance and peer review of OPTN members, and reviews events that are identified as a risk to patient safety, public health, or the integrity of the OPTN. Participation in the quality assurance and peer review process is mandatory for continued membership in the OPTN. In reporting the results of its “investigation”, the Senate Finance Committee bared these sensitive materials to the public eye in a manner and scope that served no public purpose; there was not a single point made or scored that could not have been made without revealing sensitive data.

The purpose of peer review protection is to ensure the very transparency that the Committee states that it is trying to achieve, and that Congress mandated as it passed such laws as the UNOS enabling statute and the Healthcare Quality Act. With a single publication, the Finance Committee broke the trust of the hundreds of witnesses and evaluators who have participated in UNOS’ standards’ committees over the years, and damaged the ability of this organization or any other quality review organization in the future to do its job. As any health care provider can tell you, revealing such information as patient age, gender, diagnosis and date of death, all identifying factors which could easily lead to public identification of donors or recipients violates both law and basic privacy. This breach served no public purpose except to cast aspersions on some but not all of the participants in the chain of events leading to possible medical errors. Again, without the full story, expert involvement and explanation, the citation of these ten incidents serves no purpose but to re-state cases which have already undergone complete review and disposition. Every medical professional would agree that medical errors happen, and that improvements in process are always possible. Reiterating this conclusion in this hearing and report does nothing to further quality, transparency or trust. It is merely sensationalizing the very real tragedies of the patients who were injured, while adding nothing to the journey toward quality.

Furthermore, the line of questioning related to access and equity was simply hypocritical because a number of the Senators doing the questioning had long since written letters to the Department of Health and Human Services asking to expedite Trump Administration regulations that will decertify OPOs and leave system vacuums in the organ donation and transplant ecosystem, particularly among high risk populations.

We all have a shared desire to improve organ donation outcomes through a more accountable, more equitable, and more productive organ transplantation system. The NASEM report has provided us with the tools to achieve these goals for all the patients and families who need the system to work to its full potential. We owe it to them to heed the consensus advice of our scientific community. We look forward to working with you to follow the science and build the stronger, fairer transplantation system that America deserves.

Sincerely,

Anthony Pizzutillo
Chair
Science in Donation & Transplant