HHS launches organ transplant oversight initiative after patient safety failures

Editor's Note

The Department of Health and Human Services (HHS) has launched a major initiative to reform the US organ transplant system following disturbing findings about organ procurement practices. Fierce Healthcare reported the news July 21.

According to the article, the initiative was triggered by a directive from HHS to the Organ Procurement and Transplantation Network (OPTN) to reopen a case involving potentially preventable harm to a neurologically injured patient. That directive led to a broader review of 351 authorized-but-incomplete organ donations. Of those, 73 involved patients who, according to the Health Resources and Services Administration (HRSA), had neurological signs indicating the process should have been halted.

As reported by Fierce Healthcare, the agency mandated corrective actions for the OPO involved and broader system-level changes. The HHS release included a redacted copy of a May 28 OPTN notice warning the organization—identified by The New York Times as Kentucky Organ Donor Affiliates, now Network for Hope—of potential decertification if changes are not implemented. The organization has previously disputed the characterization of the case during a September 2024 congressional hearing.

The announcement also followed a New York Times report detailing a case in which a patient was declared dead and had her chest opened for organ procurement, after which signs of heart and respiratory function were detected, the outlet reports. The Times cited 55 healthcare workers across 19 states who reported witnessing at least one similar incident of donation after circulatory death, raising concerns that pressure to boost organ donation may be weakening patient safety safeguards.

Nationwide, HRSA has now directed that all data related to safety-related donation stoppages be reported to the agency. It also instructed OPTN to improve procurement safety and ensure complete, accurate information is provided to families and hospitals.

In an HHS press release on the matter, HHS Secretary Robert F. Kennedy Jr. called the findings “horrifying” and called for accountability.