Congressional oversight hearing highlights HRSA findings of patient-safety failures in organ procurement; OPTN, OPOs face corrective actions

Congressional subcommittee on oversight and investigations leaders, Health Resources and Services Administration officials and OPTN contractors met at a July oversight hearing to examine HRSA’s March 24, 2025, investigation and a May 28, 2025 corrective action plan into the nation’s organ procurement and transplant system.

The hearing centered on HRSA’s finding that, in a review of 351 authorized-not-recovered (ANR) cases, 103 — nearly 30 percent — had “concerning features,” including failures to recognize improving neurologic function, poor collaboration with hospital teams, inadequate family communications, and weak documentation. The report focused on practices at the Kentucky Organ Donor Affiliates (CODA), now operating as Network for Hope, and on how the OPTN and its contractor handled an index case first raised to the committee in 2024.

The problem and why it matters

The hearing opened with Chairman Joyce describing the session as “Ensuring Public Safety, Oversight of the US Organ Procurement and Transplant System.” Representative Joyce and other members stressed that organ donation saves lives — last year about 48,000 transplants were performed and more than 100,000 people remain on the national waitlist — but said those facts make patient-safety concerns particularly urgent.

Dr. Raymond Lynch, chief of the Organ Transplant Branch at HRSA, described the agency’s review and the corrective action plan HRSA has issued to the OPTN. “This is a technically demanding form of care,” Lynch said. “It’s knowable and fixable. This is something that can be done safely.” He summarized four recurring problems identified in HRSA’s review: inadequate neurologic exams and reevaluations, poor collaboration and respect for hospital teams, deficient family communication, and poor documentation.

Key findings and actions

HRSA’s report analyzed more than 350 cases categorized as authorized-not-recovered (patients considered for donation after circulatory death, or DCD, but from whom organs were not ultimately transplanted). HRSA concluded that 103 cases had concerning features and directed the OPTN to take corrective actions. Among the steps HRSA requested were systemwide policy and process improvements, a 12-month monitoring plan for the Kentucky OPO, and clearer reporting channels so safety concerns reach the government directly rather than only through the contractor.

HRSA told the subcommittee it used authorities provided by the Securing the U.S. Organ Procurement and Transplantation Network Act (2023) to strengthen oversight and to stand up teams with data and subject-matter expertise. Lynch emphasized that HRSA can now receive reports directly through a public-facing site as well as receive reports submitted by OPTN members through secure channels.

OPTN, UNOS and contractor issues

Witnesses from the OPTN and its longtime contractor, United Network for Organ Sharing (UNOS), said the system must improve. Dr. Maureen McBride, CEO of UNOS, told the committee: “UNOS is here to work with all of you to make this system better.” She urged a “no wrong door” reporting system for hospitals, families and providers, and proposed broader reforms including automated donor referrals and improved national tracking.

Several members criticized how the OPTN and its contractor handled the initial review of the Kentucky index case. The committee heard that an early OPTN inquiry in September 2024 received a one-page letter from CODA and was closed after two business days; HRSA later directed the OPTN to reopen the review and then conducted a broader parallel investigation. Former OPTN volunteer leader Richard Formica, M.D., who helped lead subsequent OPTN reviews, said in retrospect the OPTN should have pursued deeper review earlier.

Network for Hope response and local changes

Barry Massa, chief executive officer of Network for Hope (the organization formed after a merger that included Kentucky Organ Donor Affiliates), said his organization is reviewing HRSA’s findings and implementing changes. “Patient safety is at the forefront of everything that we do,” Massa said. He described new local steps including checklists for bedside teams, video guidance for hospital staff and multiple “huddles” or hard stops during DCD cases so that concerns can be raised and adjudicated.

Whistleblower, retaliation and transparency

Committee members raised testimony that a whistleblower who brought the original Kentucky concerns to the committee had been pressured at their workplace. Dr. Lynch said HRSA learned of reported retaliation from media accounts and that HRSA excluded signers of a widely publicized industry letter from certain OPTN review committees. He and members stressed the need to protect those who report safety concerns.

Technology, data access and governance

Members also questioned UNOS about government access to OPTN systems and data. Panelists agreed that government access and transparency are essential. Dr. McBride said HRSA staff have been able to review UNOS systems in recent months and that UNOS supports reforms such as migrating systems to the cloud and improving data sharing. HRSA said the Securing Act allowed it to reduce conflicts of interest in OPTN governance by enabling a special election in 2024 and by establishing an independent OPTN board.

What was not decided

There were no formal votes at the hearing. HRSA’s corrective action plan remains in effect, OPTN has been directed to propose monitoring for the Kentucky OPO and to develop systemwide paused-procurement protocols, and HRSA said it will continue investigations and accept reports of patient-safety concerns. Members asked for further documentation from HRSA and OPTN and requested follow-up reports to the committee.

Voices from donor families and clinicians

Two family members who donated organs through the system — Adria Johnson and Shannon Atkins — were present and noted the life-saving effects of donation in their families. Clinicians and members of Congress stressed that protecting donors and families is essential to preserve public trust in donation and transplantation.

Outlook and next steps

Committee leaders pressed HRSA and the OPTN to move quickly to implement HRSA’s corrective actions, improve reporting and data flows, and ensure consistent policies across hospitals and OPOs for evaluating potential DCD donors. Representative Clark warned that current patterns amounted to “a cover-up culture, not a culture of concern for patient safety.” HRSA and witnesses from the OPTN and OPOs said they will work with the committee and each other on policy, training, oversight and data access to reduce the risk of harm and restore public confidence.

Members of the committee requested additional documents and set deadlines for follow-up. HRSA and OPTN witnesses were asked to produce more detailed crosswalks of case identifiers and to provide status reports on the OPTN monitoring plan and other corrective steps.

Ending

The hearing highlighted systemwide problems identified by HRSA and underscored the tension between expanding organ access and ensuring rigorous safeguards. Lawmakers and agency officials left the hearing agreeing that the system must preserve donor dignity and patient safety while maintaining public trust that enables lifesaving transplants.