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

House Energy & Commerce Oversight & Investigations Subcommittee

July 22nd, 2025 (recording linked here)

WITNESSES & TESTIMONIES

• Dr. Raymond Lynch, MD, MS, FACS, Chief, Organ Transplant Branch, Health Resources and Services Administration, U.S. Department of Health and Human Services

• Barry Massa, Chief Executive Officer, Network for Hope

• Maureen McBride, PhD, Chief Executive Officer, United Network for Organ Sharing

• Richard Formica, MD, Former President, Organ Procurement and Transplantation Network Board of Directors

• John C. Magee, MD, President, Organ Procurement and Transplantation Network Board of Directors

HEARING HIGHLIGHTS

MEMBER OPENING STATEMENTS

• Subcommittee Chair Joyce (R-PA) emphasized the importance of transparency and reform in the U.S. organ procurement and transplant system. He noted that while transplants save lives, recent allegations revealed failures in patient safety and oversight, particularly concerning a Kentucky-based OPO. HRSA’s investigation identified lapses in documentation, patient care, and response protocols, prompting the issuance of a corrective action plan. He committed the committee to continued bipartisan oversight to restore trust and accountability in the system.

• Subcommittee Ranking Member Clarke (D-NY) recounted the troubling case from Kentucky in which a patient was nearly subjected to organ procurement despite signs of consciousness and ultimately recovered. Clarke criticized the Kentucky OPO’s retaliation against a whistleblower and highlighted HRSA’s findings that 103 of 351 reviewed cases had serious concerns. She praised HRSA’s recent actions and Congresswoman Robin Kelly’s advocacy in securing reforms, stressing the need to rebuild public trust in organ donation.

• Full Committee Chair Guthrie (R-KY) shared a personal story of his mother, who died while waiting for a liver transplant, to illustrate the stakes involved. He supported organ donation but stressed that recent failures must be addressed openly to maintain public confidence. Guthrie emphasized that the HRSA report revealed involvement from both hospitals and the OPO in the mishandled Kentucky case. He urged all stakeholders to acknowledge the issues and work constructively to ensure the system functions with integrity and transparency.

• Full Committee Ranking Member Pallone (D-NJ) emphasized the need for a trustworthy organ donation system, noting that over 100,000 people are currently on transplant waiting lists. He expressed concern over HRSA’s findings of aggressive procurement tactics and the failure to act on patient consciousness in the Kentucky case. Pallone criticized stakeholders who attempted to downplay the incident and praised HRSA’s increased oversight and modernization efforts. He warned that recent staff cuts at HHS threaten progress and called for continued reforms to promote accountability and safety.

WITNESS OPENING STATEMENTS

• Dr. Lynch explained that outdated statutory constraints had previously limited HRSA's ability to oversee the OPTN effectively. With new congressional authorities and appropriations in 2023, HRSA launched the OPTN Modernization Initiative, including governance changes and expanded oversight. Lynch emphasized that these structural improvements are essential to creating a transparent and accountable system that prioritizes patient safety and fairness.

• Mr. Massa emphasized that OPOs do not provide medical care, declare death, or recover organs from living patients, and asserted that patient safety is central to their mission. Massa acknowledged the seriousness of the March 2025 HRSA report and pledged that Network for Hope would address all concerns raised. He concluded by sharing personal stories of donor families and reaffirmed his commitment to strengthening public trust and improving donation practices.

• Dr. McBride explained that UNOS supports the organ transplant network (OPTN) by managing the national waitlist, facilitating organ matching, and maintaining compliance data, but does not provide patient care or influence medical decisions. While acknowledging the need for reforms, she urged Congress to implement a “No Wrong Door” patient safety reporting system and proposed three additional reforms: automated referrals, a national organ tracking system, and cloud migration of OPTN data. Dr. McBride affirmed UNOS’s readiness to collaborate with stakeholders to strengthen the system’s fairness, safety, and transparency.

• Dr. Formica outlined OPTN’s limitations in oversight authority, clarifying that the network has no jurisdiction over donor hospitals or patient care prior to death. He described the unprecedented nature of the OPTN’s chart review following the Kentucky case and said that despite constraints, the board’s conclusions aligned closely with HRSA’s. Dr. Formica expressed pride in the committee’s work and reiterated the importance of continued improvement in DCD (donation after circulatory death) policy as technology advances.

• Dr. Magee emphasized his personal commitment as a transplant surgeon of 25 years to the dignity and autonomy of donors and their families. He recounted his experiences in operating rooms, praising the collaboration among donor hospitals, OPOs, and transplant teams. While acknowledging past failures, he underscored that trust must be preserved through transparency and continuous improvement. Dr. Magee pledged the board’s full support for modernization efforts and warned that reforms must be responsible to avoid undermining the system’s foundational principles.

QUESTION AND ANSWER SUMMARY

• Rep. Joyce (R-PA) discussed Donation after Circulatory Death (DCD) cases, with Dr. Lynch clarifying that organ procurement must halt immediately if a patient shows neurological improvement. Dr. Lynch identified issues such as inadequate assessments, poor communication, and insufficient oversight as areas needing systemic improvements.

  Rep. Joyce questioned on CODA's handling of the index case and potential retaliation against whistleblowers. Mr. Massa committed to improved communication and ensuring no retaliation occurs. Dr. Formica acknowledged the OPTN's inadequate initial investigation and stressed the need for deeper oversight.

• Rep. Clarke (D-NY) addressed HRSA's increased oversight following the Kentucky OPO incident. Dr. Lynch attributed HRSA’s enhanced oversight capability to the U.S. OPTN Act and outlined improvements in data reporting and direct incident management to prevent similar lapses.

  Rep. Clarke highlighted systemic inequities in organ allocation affecting black patients, citing discriminatory practices and urging immediate corrective actions. Dr. McBride acknowledged ongoing lawsuits and the need for improved oversight and equitable allocation practices.

• Rep. Guthrie (R-KY) focused on restoring confidence in organ donation processes, particularly differentiating brain-death and circulatory-death procedures. Dr. Lynch emphasized the need for clearer neurological assessment policies and better OPO training.

  Rep. Guthrie emphasized Kentucky's failures in handling donor cases, questioning on corrective measures implemented by CODA. Mr. Massa outlined changes including improved training, enhanced communication protocols, and procedural checklists.

• Rep. Pallone (D-NJ) emphasized the importance of transparency and consistent standards across OPOs. Dr. Lynch supported transparency, arguing it strengthens public trust and systemic improvement.

• Rep. Balderson (R-OH) inquired about neurological assessment failures, highlighting the Kentucky case as a critical example. Dr. Lynch recommended clearer protocols and consistent training provided by OPOs to hospitals to ensure standardized care.

  Rep. Balderson queried on specifics of current training, reporting systems, and actions to rectify ongoing issues. He emphasized the importance of transparent communication and robust policies to restore public trust.

• Rep. DeGette (D-CO) highlighted concerns around pressure on hospitals by OPOs regarding circulatory death certification, referencing recent investigative journalism. Dr. Lynch acknowledged increased organ recovery efforts and emphasized that performance expectations should never compromise compliance and patient safety.

  Rep. DeGette also questioned potential conflicts of interest under the previous OPTN governance structure, which Dr. Lynch confirmed were problematic and are being addressed through a newly structured independent board.

  Rep. DeGette strongly criticized the inadequate oversight and flawed initial responses by CODA and OPTN.

• Rep. Palmer (R-AL) discussed concerns about transparency and accountability, highlighting instances of potential obstruction by industry groups. Dr. Lynch confirmed efforts by HRSA to increase transparency and accountability through direct oversight and corrective action plans.

• Rep. Tonko (D-NY) raised concerns regarding OPOs’ communication with patient families, particularly inappropriate interactions with impaired or intoxicated family members. Dr. Lynch detailed HRSA’s corrective action plans, emphasizing improved training and clearer policies to ensure ethical, respectful interactions with families.

• Rep. Fulcher (R-ID) focused on public trust and safety, questioning HRSA’s processes for reporting safety concerns. Dr. Lynch described accessible reporting mechanisms and emphasized the importance of transparency and thorough investigations to maintain public confidence.

• Rep. Trahan (D-MA) emphasized data integrity and IT infrastructure security within the organ transplant network. Dr. Lynch confirmed HRSA’s ongoing efforts to secure complete government access to data and systems, addressing historical challenges and obstruction by the legacy contractor.

  Rep. Trahan asked about the role of technology in ensuring data accuracy and transparency in the transplant process. Dr. Formica and Dr. Magee emphasized the need for interoperable systems between OPOs and hospitals and discussed ongoing efforts to improve data exchange and accountability using federal support.

• Rep. Harshbarger (R-TN) questioned specifics about declaring time of death and potential retaliation against whistleblowers. Dr. Lynch highlighted problematic blurred lines in patient care due to OPO procedures, emphasizing the need for clearer, standardized DCD procurement policies.

  Rep. Harshbarger raised concerns about inconsistent time-of-death determinations and possible retaliation against whistleblowers. Mr. Massa acknowledged prior inconsistencies and pointed to procedural reforms and a strengthened reporting culture. Dr. Formica reiterated that physicians—not OPOs—must make death determinations and noted training gaps.

• Rep. Ocasio-Cortez (D-NY) discussed the essential role of OPOs in organ procurement and raised concerns regarding troubling patient safety cases and pressures exerted by OPOs on medical teams. Dr. Lynch emphasized the importance of nationwide safety protocols and HRSA’s ongoing corrective actions.

  Rep. Ocasio-Cortez questioned the power dynamics between hospitals and OPOs, specifically the pressure placed on physicians to certify death prematurely. Mr. Massa denied coercion but acknowledged the need for cultural change. Dr. McBride highlighted reforms under the new OPTN contract, including new performance metrics to address such concerns.

• Rep. Weber (R-TX) asked about the timeline of HRSA’s intervention and how initial complaints were handled. Dr. Lynch recounted the escalation process and emphasized the importance of independent board oversight, noting that prior contractor barriers limited HRSA’s visibility.

• Rep. Mullin (D-CA) stressed the importance of clearly defining roles between OPOs and hospitals to prevent harm, emphasizing proactive oversight strategies and clear delineation of responsibilities.

  Rep. Mullin stressed the confusion surrounding roles between hospitals and OPOs and asked for a clearer delineation of responsibility in DCD cases. Dr. Formica agreed that overlapping authority has led to errors and called for a unified national framework. Mr. Massa also agreed on the need for cross-institution training and communication improvements.

• Rep. Dunn (R-FL) highlighted concerns with the current circulatory death protocols, suggesting standardized use of brain death assessments instead. Dr. Lynch concurred that rigorous evaluation criteria are essential.

  Rep. Dunn questioned about the continued employment of former CODA executives, including the prior CEO, now serving as COO. Mr. Massa noted that former staff were retained but in different roles.

  Rep. Dunn criticized a previous letter from the organ procurement association that dismissed congressional concerns and reaffirmed Congress’s oversight role, stressing that any disregard for safeguards threatens public trust and donor participation.

• Rep. Schrier (D-WA) raised issues about inadequate medical training regarding DCD processes, particularly in smaller hospitals. Dr. Lynch acknowledged these gaps and emphasized the importance of standardized training and procedural protocols.

  Rep. Schrier emphasized the need for standardized checklists to prevent errors in the DCD process and asked whether such checklists currently exist. Mr. Massa described internal checklists used by OPOs and clarified that they do not declare death, which remains the responsibility of independent physicians. Dr. Formica supported the idea of a unified protocol between hospitals and the OPTN to ensure consistent oversight and build public trust.

• Rep. Allen (R-GA) addressed problematic consent procedures, particularly involving impaired family members, and questioned potential conflicts of interest within the OPTN structure. Dr. Lynch detailed recent corrective actions to mitigate these concerns.

  Rep. Allen questioned about OPTN data collection policies and whether OPO staff were qualified to assess patients’ neurological condition. Dr. Formica expressed discomfort with non-physicians making clinical assessments and stressed that physicians should document neurological status.

  Rep. Allen also inquired about organ donor data shared with transplant centers, and Mr. Massa outlined the comprehensive information provided, including donor history and lab results. He confirmed complaints are also included via a confidential system.

• Rep. Houchin (R-IN) expressed deep concerns about systemic oversight failures, highlighting serious ethical lapses by Kentucky OPOs and potential conflicts of interest in the oversight process. Dr. Lynch confirmed HRSA's corrective action plans are in place to address these issues comprehensively.

  Rep. Houchin asked about HRSA’s 12-month monitoring plan. Mr. Massa and Dr. Lynch confirmed coordination is underway and the plan is due by month’s end.

• Rep. Miller-Meeks (R-IA) discussed the importance of trust in the organ donation system, highlighting recent public concerns and the need for automated referral systems. Dr. Lynch agreed on the need for proactive oversight and system-wide improvements.

  Rep. Miller-Meeks discussed her bill promoting automated referrals and asked how funding has been used. Dr. Lynch outlined contract expansions, technology improvements, and community engagement.