The Department of Health and Human Services announced a major effort to reform the organ transplant system following a probe that revealed shocking practices from a major organ procurement organization.
The initiative was prompted after the Health Resources and Services Administration ordered the Organ Procurement and Transplantation Network (OPTN) to reopen a “disturbing” case in Kentucky where a man was thought to be brain-dead. Doctors were wrong, however, and the organ harvesting surgery was canceled right before he was to be taken off life support as a physician noticed him moving and making sounds. He wasn’t the only one.
Under Secretary Kennedy’s leadership, HRSA demanded a thorough, independent review of the OPO’s [organ procurement organization] 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. (HHS)
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“Our findings show that hospitals allowed the organ procurement process to begin when patients showed signs of life, and this is horrifying,” HHS Secretary Kennedy said in a statement. “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.”
Our findings show that hospitals allowed the organ procurement process to begin when patients showed signs of life, and this is horrifying. The organ procurement organizations that coordinate access to transplants will be held accountable. The entire system must be fixed to… https://t.co/DeiFa2FlEJ
— Secretary Kennedy (@SecKennedy) July 22, 2025
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