The U.S. Department of Health and Human Services (HHS) under the leadership of Secretary Robert F. Kennedy, Jr. today announced a major initiative to begin reforming the organ transplant system following an investigation by its Health Resources and Services Administration (HRSA) that revealed disturbing practices by a major organ procurement organization.
“Our findings show that hospitals allowed the organ procurement process to begin when patients showed signs of life, and this is horrifying,” Secretary Kennedy said. “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.”
HRSA directed the Organ Procurement and Transplantation Network (OPTN) to reopen a disturbing case involving potentially preventable harm to a neurologically injured patient by the federally-funded organ procurement organization (OPO) serving Kentucky, southwest Ohio, and part of West Virginia. Under the Biden administration, the OPTN’s Membership and Professional Standards Committee closed the same case without action.
Under Secretary Kennedy’s leadership, HRSA demanded a thorough, independent review of the OPO’s conduct and the treatment of vulnerable patients under its care. HRSA’s independent investigation revealed clear negligence after the previous OPTN Board of Directors claimed to find no major concerns in their internal review.
HRSA examined 351 cases where organ donation was authorized, but ultimately not completed. It found:
- 103 cases (29.3%) showed concerning features, including 73 patients with neurological signs incompatible with organ donation.
- At least 28 patients may not have been deceased at the time organ procurement was initiated—raising serious ethical and legal questions.
- Evidence pointed to poor neurologic assessments, lack of coordination with medical teams, questionable consent practices, and misclassification of causes of death, particularly in overdose cases.
Vulnerabilities were highest in smaller and rural hospitals, indicating systemic gaps in oversight and accountability. In response to these findings, HRSA has mandated strict corrective actions for the OPO, and system-level changes to safeguard potential organ donors nationally. The OPO must conduct a full root cause analysis of its failure to follow internal protocols—including noncompliance with the five-minute observation rule after the patient’s death—and develop clear, enforceable policies to define donor eligibility criteria. Additionally, it must adopt a formal procedure allowing any staff member to halt a donation process if patient safety concerns arise.
HRSA also took action to make sure that patients across the country will be safer when donating organs by directing the OPTN to improve safeguards and monitoring at the national level. Under HRSA’s directive, data about any safety-related stoppages of organ donation called for by families, hospitals, or OPO staff must be reported to regulators, and the OPTN must update policies to strengthen organ procurement safety and provide accurate, complete information about the donation process to families and hospitals.
These findings from HHS confirm what the Trump administration has long warned: entrenched bureaucracies, outdated systems, and reckless disregard for human life have failed to protect our most vulnerable citizens. Under Secretary Kennedy’s leadership, HHS is restoring integrity and transparency to organ procurement and transplant policy by putting patients’ lives first. These reforms are essential to restoring trust, ensuring informed consent, and protecting the rights and dignity of prospective donors and their families.
HHS recognizes House Committee on Energy and Commerce Chairman Brett Guthrie’s (KY-02) bipartisan work to improve the organ transplant system and looks forward to working with him and other issue-area champions in Congress to deliver reforms.
SOURCE HHS Press Office