The U.S. Department of Health and Human Services (HHS), under Secretary Robert F. Kennedy Jr., unveiled plans to overhaul the nation’s organ transplant system after a Health Resources and Services Administration (HRSA) probe uncovered serious ethical violations by an organ procurement organization (OPO) serving Kentucky, southwest Ohio, and parts of West Virginia.
“Our findings show that hospitals allowed the organ procurement process to begin when patients showed signs of life, and this is horrifying,” Kennedy said in an HHS press release. “The organ procurement organizations that coordinate access to transplants will be held accountable. The entire system must be fixed to ensure that every potential donor’s life is treated with the sanctity it deserves.”
The investigation, which reopened a case previously closed without action under the Biden administration, focused on a federally funded OPO’s handling of a neurologically injured patient. HRSA’s review of 351 uncompleted organ donation cases found 103 (29.3%) with troubling issues, including 73 patients showing neurological signs incompatible with organ donation. Alarmingly, at least 28 patients may not have been deceased when organ procurement began, raising ethical and legal concerns.
The probe highlighted inadequate neurologic assessments, poor coordination with medical teams, questionable consent practices, and misclassification of death causes, particularly in overdose cases, with smaller and rural hospitals showing the greatest vulnerabilities.
HRSA has ordered the OPO to conduct a root cause analysis of its failure to adhere to protocols, including the five-minute post-death observation rule, and to establish clear donor eligibility criteria and a process for staff to halt donations due to safety concerns. Secretary Kennedy warned that noncompliance could lead to the OPO’s decertification.
Nationally, HRSA directed the Organ Procurement and Transplantation Network (OPTN) to strengthen safeguards, requiring reports on any safety-related donation stoppages and updated policies to ensure transparent information for families and hospitals.
The reforms aim to rebuild trust in a system where over 100,000 patients await transplants, despite a record 42,888 performed last year.
HHS acknowledged bipartisan efforts by House Committee on Energy and Commerce Chairman Brett Guthrie (R-KY) to improve the system and pledged to collaborate with Congress on further reforms.
The investigation continues as HHS seeks to enhance oversight and protect prospective donors.