Ensuring Patient Safety: Oversight of the U.S. Organ Procurement and Transplant System

House Energy and Commerce Subcommittee on Oversight and Investigations

2025-07-22

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Source: Congress.gov

Summary

The meeting convened to address serious concerns regarding patient safety and systemic failures within the U.S. Organ Procurement and Transplant System, primarily focusing on issues identified at the Kentucky Organ Donor Affiliates (KYDA), now Network for Hope, and the broader oversight provided by the Organ Procurement and Transplantation Network (OPTN) and the Health Resources and Services Administration (HRSA). [ 00:20:18-00:20:28 ] [ 00:22:09 ]

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 The discussion centered on past deficiencies, ongoing reforms, and the critical need to restore public trust in the organ donation process. [ 00:37:03 ]

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Themes

Patient Safety Failures and Inadequate DCD Protocols

The central issue discussed was a "horrifying" incident in Kentucky involving a potential organ donor who showed signs of consciousness and distress while being prepped for organ recovery, despite being declared a DCD candidate. [ 03:22:28 ]

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 HRSA's investigation into KYDA (now Network for Hope) found 103 out of 351 cases with "concerning features," including failures to recognize neurological function improvements and poor patient care. Concerns were raised about patients being evaluated for organ donation while under the influence of sedatives and paralytics, which can mask actual neurological status. [ 02:19:49-02:19:58 ]

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 Speakers emphasized that proper neurological assessment and immediate cessation of the process upon signs of improvement are critical to patient safety. The lack of clear, consistent policies for DCD (Donation after Circulatory Death) procurement was highlighted as contributing to these issues, particularly in smaller, rural hospitals. [ 02:02:02-02:02:05 ]

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Oversight, Accountability, and Whistleblower Protection

HRSA's investigation was initiated after the Kentucky incident came to light during a prior subcommittee hearing, leading to a corrective action plan for the OPTN. [ 00:21:46-00:23:03 ]

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 Initially, both KYDA and the OPTN were criticized for downplaying the seriousness of the Kentucky case and for accepting an unsubstantiated report from KYDA without further investigation. The incident also involved alleged retaliation against a whistleblower who exposed the Kentucky case, with concerns about a "cover-up culture." HRSA's new authorities under the Securing the U.S. OPTN Act enabled more robust oversight, including the ability to conduct its own investigations and direct the OPTN. The newly established, independent OPTN board is expected to provide stronger system-level oversight and ensure patient safety. [ 00:50:58-00:51:06 ]

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Systemic Issues and Reform

The historical structure of the OPTN, with a single contractor (UNOS) also serving as the board, created conflicts of interest and limited meaningful government oversight. This led to concerns about transparency, effectiveness, and accountability within the system. There were also allegations that UNOS obstructed government access to its technology and data, demanding compensation for taxpayer-funded systems. [ 01:32:18 ]

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 The need for standardized protocols, better data collection, and improved collaboration between OPOs, hospitals, and oversight bodies was frequently emphasized. [ 01:03:45-01:03:56 ]

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 Concerns were raised about systemic inequities, including lawsuits against UNOS for alleged racist practices and the "skipping" of waiting lists, disproportionately affecting Black patients and rural populations. [ 03:04:00-03:04:12 ]

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Impact on Public Trust and Organ Donation

Several speakers highlighted that these failures undermine public trust, which is crucial for encouraging organ donation. [ 00:53:59-00:54:01 ]

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 The Iowa Donor Network experienced a 78% increase in registry removal requests after the Kentucky case became public, illustrating the fragility of this trust. Members stressed that restoring confidence through transparency, accountability, and ethical practices is essential to ensure a robust donor pool and save lives. [ 02:18:37-02:18:41 ]

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Tone of the Meeting

The tone of the meeting was largely serious, concerned, and critical, with members expressing shock and horror at the reported patient safety failures. Many speakers emphasized the need for immediate and comprehensive reform, often conveying a sense of urgency and disappointment regarding past oversight deficiencies. [ 00:37:15 ]

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 While acknowledging the life-saving potential of organ donation, there was a strong bipartisan call for greater transparency, accountability, and the restoration of public trust in the system. [ 00:24:40 ]

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[ 00:37:03 ]

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[ 01:04:13 ]

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Participants

Transcript

Okay.   Thank you.
The Subcommittee on Oversight and Investigations will now come to order.  The chair now recognizes himself for five minutes of an opening statement.  Good morning.   and welcome to today's hearing entitled, Ensuring Public Safety, Oversight of the U.S.  Organ Procurement and Transplant System.  I want to begin this hearing by saying that it is an honor to serve as the chairman of this subcommittee, and I look forward to working on a bipartisan basis to shed light on many areas in need of oversight and reform.  Just last year, 48,000 organ transplants were performed in the United States.   Many of us know someone who is an organ donor or an organ recipient.  That might be relatives, friends, neighbors, coworkers.  These procedures are often life-saving and can extend an individual's life by years, if not by decades.  While organ transplants are a relief to so many families, there's actually another side to the story that is equally important, and that is the story of the donors and their loved ones.   In September of last year, the subcommittee held a hearing to conduct oversight of the organ transplant and procurement system, as well as implementation of the Securing the U.S.  Organ Procurement and Transplantation Network Act, which was signed into law in September of 2023.  During that hearing, certain allegations came to light, raising concerns whether practices and procedures were putting patient safety at risk,   Following the hearing, the Health Resources and Services Administration, known as HRSA, directed the Organ Procurement and Transplantation Network or OPTN to investigate the issue to better understand what transpired in one of these alleged incidents.  HRSA also conducted its own investigation.   The agency compiled a report that describes practices at the Organ Procurement Organization, OPO, formerly known as the Kentucky Organ Donor Affiliates, CODA, but is now known as the Network for Hope.
The report also details the failures by the OPO and the OPTN to adequately recognize and respond to poor patient care and quality practices.   HRSA then issued a corrective action plan to the OPTN, directing them to take specific actions to address the concerns that were identified in the reviews.  I asked unanimous consent to enter HRSA's report dated March 24th, 2025 and HRSA's corrective action plan dated May 28th, 2025 into the hearing record.   Without objection, so ordered.  The report provided a detailed overview of HRSA's investigation, including about what is referred to as the index case, OPTN, the OPTN contractor, and COTA, and finally, COTA's organ procurement in recent years.   As part of the review of the cases beyond the index case, HRSA focused on the overall medical presentation and initial and subsequent neurologic status of patients, staff interactions with patients and families, and primary medical teams,   and evidence of robust documentation and quality assurance procedures.  Lastly, the report includes an appendix consisting of OPTN's findings following the HRSA directed review.  For every doctor, one of the most important tenants in the doctor-patient relationship is, above all, do no harm.   But what happened in these cases fractured the doctor-patient relationship and saw patients subjected to pain and suffering that should never have occurred.  As a member of Congress, we all swore an oath to protect the constitutional right to life afforded to each and every American.  These incidents cannot be allowed to stand without strict investigation and oversight in the spirit of our constitutional oath.
the federal government plays a critical role in ensuring the organizations tasked with administering and overseeing our nation's organ procurement and transplant operate safely, effectively, and in accordance with the law.  Transparency is key to improving the system and repairing the public trust.   This committee has and will continue to follow the facts so that we can restore trust and accountability within the system.  I want to thank the witnesses from both panels for joining us today.  I look forward to hearing from each of you about the challenges facing the organ procurement and transplant system, the ways that the system can be improved, and how we can ensure the safety of all patients who elect to be organ donors.   I now recognize the ranking member of the subcommittee, Ms.  Clark, for her opening statement.
Thank you very much, Mr. Chairman.  I'd like to congratulate you on being named the new oversight and investigations chair.  There's a great deal of important oversight to be done, including today's hearing, and I hope we can work together to sign a light on the problems across the broad jurisdiction of the committee and ensure that our government is working   to improve the lives of Americans.  Today's hearing is an important step toward improving confidence in America's organ donation system by confronting some of its problems head on.  The Health Resources and Services Administration, or HRSA, and the entity that it oversees, the Organ Procurement and Transplantation Network, or OPTN, reacted to a troubling story that came to light during a hearing in this subcommittee last year.   In that case, a patient in a Kentucky hospital had been identified as a likely donor and with the consent of his family, began the various tests and procedures necessary to evaluate the viability of his organs for donation prior to his removal from life support.  At numerous points throughout the process, both hospital staff and the staff from the Organ Procurement Organization noted potential signs   of consciousness and discomfort from the patient.  Nevertheless, the process proceeded all the way to the point that the patient was in the operating room.  At that point, however, the surgeon ultimately refused to operate, stating they felt the operation would be inhumane and unethical.  The patient ultimately recovered and was later discharged from the hospital and is still alive today.

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