(The Center Square) – The Department of Health and Human Services plans to overhaul an organ transplant system after an investigation found what federal officials called “disturbing practices.”
HHS Secretary Robert F. Kennedy, Jr. announced an initiative Monday begin reforming the organ transplant system following an investigation by its Health Resources and Services Administration.
“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 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.”
HRSA directed the Organ Procurement and Transplantation Network, or OPTN, to reopen a case involving potentially preventable harm to a neurologically injured patient by the federally-funded organ procurement organization serving Kentucky, southwest Ohio, and part of West Virginia.
The OPTN’s Membership and Professional Standards Committee closed the same case without action during the Biden administration.
Under Kennedy, HRSA demanded an 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 corrective actions for the OPO and system-level changes to safeguard potential organ donors nationwide. The OPO must conduct a complete root cause analysis of its failure to follow internal protocols – including non-compliance with the five-minute observation rule after the patient’s death – and develop clear, enforceable policies to define donor eligibility criteria, according to a news release. 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 ensure 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.
