HHS to overhaul organ transplant process after investigation

The Department of Health and Human Services has directed the Organ Procurement and Transplantation Network to begin reforming the organ transplant system, and to reopen an investigation into an organ procurement company based in Louisville, Kentucky.

The case, according to HHS, involved “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.

HHS’ Health Resources and Services Administration (HRSA) examined 351 cases where organ donation was authorized, but ultimately not completed.

It found 103 cases – 29.3% of the total – that showed what the agency called “concerning features,” including 73 patients with neurological signs “incompatible with organ donation.”

HRSA said that an additional 28 patients may not have been deceased when organ procurement was initiated, which the agency said raises ethical and legal concerns, adding that the 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.”

Smaller and more rural hospitals were more vulnerable, with systemic gaps in oversight, HHS said. 

HRSA has mandated strict corrective actions for the OPO, and system-level changes meant to safeguard patients nationally. At the agency’s behest, 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 directed the Organ Procurement and Transplantation Network (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.