Allegations of Kentucky group's organ donation misconduct warranted federal review Image By Dr. Raymond Lynch This is a lightly edited excerpt of testimony recently provided to the U.S. House Energy and Commerce Oversight and Investigations Subcommittee during the hearing “Ensuring Patient Safety: Oversight of the U.S. Organ Procurement and Transplant System.” Historically, the U.S. Health Resources and Services Administration (HRSA) did not receive complete, consistent and, at times, accurate information regarding patient safety complaints and concerns raised by Organ Procurement and Transplantation Network (OPTN) members and other stakeholders. Passage of the Securing the OPTN Act enabled HRSA to begin its modernization efforts to separate OPTN Board functions from OPTN contractor functions. However, that was not the case for the issue we are discussing regarding reports of alleged misconduct by Kentucky Organ Donor Affiliates (KYDA), since renamed Network for Hope, an organ procurement organization (OPO) providing care to patients across Kentucky, and in counties in Ohio and West Virginia. HRSA first learned of this alleged misconduct following the September 2024 House Energy and Commerce Oversight and Investigations Subcommittee Hearing, “A Year Removed: Oversight of Securing the U.S. Organ Procurement and Transplantation Network Act Implementation." At that time, this subcommittee shared a letter alleging that, in 2021, a patient had been inaccurately pronounced dead and was improperly pursued as an organ donor by KYDA. According to the letter, the patient, who was a victim of a drug overdose, showed clear signs of life at multiple points, but KYDA senior staff directed that organ procurement proceed. The incident reporter further claimed that the operation was halted only after the procuring surgeon refused to participate in the organ recovery. The incident reporter claimed that the patient was later discharged from the hospital. The subcommittee shared the allegations on Sept. 11, 2024. On Sept. 12, 2024, the OPTN’s Membership and Professional Standards Committee (MPSC) sent KYDA a detailed request for materials relevant to the allegation. KYDA responded on Sept. 20 with a single-page letter that claimed they were “satisfied and confident” in the care provided to the patient without providing any materials requested by the MPSC. In response, the MPSC moved to close the investigation on Sept. 24, 2024. HRSA noted that KYDA had not adequately addressed questions raised by MPSC, and on Oct. 1, 2024, directed the OPTN to reopen the investigation. Based on materials subsequently provided by KYDA, HRSA directed the OPTN on Oct. 18, 2024, to broaden the scope of their review to all patients since 2021 who had been entered into the donation after circulatory death (DCD) pathway but from whom no organs had been recovered. As HRSA was directing the OPTN to conduct this review of KYDA practices, an industry trade group, the Association of Organ Procurement Organizations (AOPO), publicized an open letter characterizing the ongoing effort to improve patient safety through enhanced oversight as a “misinformation conspiracy campaign,” and concluded “[i]t is time for it to stop.” Among the signatories to this letter were more than 20 UNOS staff signing with their corporate affiliation, including the chief executive officer, chief legal officer and general counsel, special counsel for Contract Operations, and the director of Member Quality and Contract Operations. Additional signers included two members of OPTN board of directors and a member of the MPSC. These signatures raised serious concerns about the objectivity of the OPTN leadership and contractor. HRSA proceeded with parallel investigative processes. HRSA directed the OPTN and UNOS to proceed with reviewing materials received responsive to HRSA’s Oct. 18 direction, and, on Nov. 20, 2024, HRSA requested clarification from contractor staff on a plan to mitigate the potential conflicts of interest as identified, given the above-referenced industry letter. HRSA supplemented its direction on Dec. 6, 2024, with an additional requirement for the OPTN’s investigation into KYDA to exclude any individual who signed the industry letter. Finally, in response to further anonymous reporting of a concerning case from December 2024, on Jan. 8, 2025, HRSA directed that KYDA supply, and the OPTN review patient records from attempted DCD procurements through the end of calendar year 2024. On March 4, 2025, the OPTN concluded its investigation and identified no major concerns or patterns. In contrast, in HRSA’s March 24, 2025, memo and subsequent May 28, 2025, letter to the OPTN, we found that KYDA has engaged in a pattern of concerning DCD practices that expose patients to risk of preventable harm and potentially unsafe conditions. In addition, HRSA found that KYDA failed to accurately report relevant data to the OPTN. Findings also suggest that the OPTN did not adequately recognize and respond to poor patient care and practices in this instance. Read the full testimony here. Listen to an excerpt of his testimony here. Dr. Raymond Lynch is the chief of the Organ Transplant Branch of the Health Systems Bureau at the Department of Health and Human Services. *The opinions expressed in this column are those of the author and do not necessarily reflect the views of HealthPlatform.News.
