WASHINGTON, D.C. – The U.S. Department of Health and Human Services (HHS) announced sweeping reforms to the nation’s organ transplant system following an investigation that uncovered serious deficiencies in organ procurement practices in parts of Kentucky, southwest Ohio, and West Virginia.

The Health Resources and Services Administration (HRSA), a division of HHS, conducted a review of a federally funded organ procurement organization (OPO) and found multiple instances where organ procurement was initiated despite patients showing signs of life. The investigation identified at least 28 cases where it was unclear whether patients were deceased before donation began, raising significant ethical and legal concerns.

The review examined 351 cases in which organ donation was authorized but not completed. Findings included:

• 103 cases (29.3%) presented concerning features.
• 73 patients reportedly had neurological signs incompatible with organ donation.
• Issues such as poor neurologic assessments, questionable consent processes, and misclassification of cause of death, particularly in overdose-related cases.

According to HRSA, smaller and rural hospitals showed the greatest vulnerabilities, highlighting broader systemic gaps in oversight and accountability.

In response, HHS has directed the OPO involved to conduct a full root cause analysis and implement stricter protocols, including:

• Adherence to a five-minute observation rule following a declaration of death.
• The creation of enforceable donor eligibility criteria.
• A formal procedure allowing any staff member to halt the donation process if concerns arise.

At the national level, HHS has instructed the Organ Procurement and Transplantation Network (OPTN) to revise its safety protocols. OPTN is now required to report all safety-related donation stoppages and update its policies to improve communication with families and medical teams.

HHS Secretary Robert F. Kennedy, Jr. stated that if the OPO fails to comply with the mandated corrective actions, it may be decertified. He also acknowledged support from congressional partners, including House Energy and Commerce Committee Chair Brett Guthrie (R-KY), for ongoing efforts to reform the system.

The findings and subsequent actions reflect a broader push by HHS to increase transparency and ensure the ethical treatment of potential organ donors nationwide.