WASHINGTON, DC – The U.S. Department of Health and Human Services (HHS), led by Secretary Robert F. Kennedy, Jr., unveiled a major reform initiative at 1:02 PM EDT on Monday, July 21, 2025, to address systemic issues within the nation’s organ transplant system. An investigation by the Health Resources and Services Administration (HRSA) exposed disturbing practices by a federally-funded organ procurement organization (OPO) serving Kentucky, southwest Ohio, and part of West Virginia.Secretary Kennedy expressed alarm, stating, “Our findings reveal that hospitals permitted organ procurement to begin while patients showed signs of life—a horrifying violation.” He emphasized holding OPOs accountable and reforming the system to honor the sanctity of every potential donor’s life.The HRSA probe, which reopened a case previously dismissed under the Biden administration, uncovered negligence after an independent review contradicted the Organ Procurement and Transplantation Network’s (OPTN) earlier findings of no major concerns. The investigation analyzed 351 cases where organ donation was authorized but not completed, revealing:
- 103 cases (29.3%) with troubling features, including 73 patients showing neurological signs incompatible with donation.
- At least 28 patients potentially alive when procurement began, raising ethical and legal issues.
- Evidence of poor neurologic assessments, inadequate medical coordination, questionable consent, and misclassified deaths, especially in overdose cases.
- Greater vulnerabilities in smaller and rural hospitals, pointing to oversight gaps.
HRSA has ordered the OPO to conduct a root cause analysis, address noncompliance with the five-minute observation rule post-death, and establish clear donor eligibility criteria. The OPO must also allow staff to halt donations if safety concerns arise, with decertification threatened by Secretary Kennedy if requirements are unmet.Nationally, HRSA directed the OPTN to enhance safeguards, mandating data reporting on safety-related donation stoppages and updating policies for transparency with families and hospitals. HHS frames these reforms as a response to the Trump administration’s warnings about bureaucratic failures, aiming to restore trust and protect vulnerable patients.HHS also commended House Energy and Commerce Committee Chairman Brett Guthrie (KY-02) for his bipartisan efforts and plans to collaborate with Congress on further improvements.
