Agency wants to strengthen national safeguards and monitoring to improve organ donation safety
By Stephanie Brown HealthDay Reporter
TUESDAY, July 22, 2025 (HealthDay News) — The U.S. Department of Health and Human Services has announced a major initiative to reform the organ transplant system. This action follows an investigation by the Health Resources and Services Administration (HRSA) that uncovered possible troubling practices at a major organ procurement organization.
The HRSA has ordered the Organ Procurement and Transplantation Network (OPTN) to reopen a case involving potentially preventable harm to a neurologically injured patient caused by the federally funded organ procurement organization serving Kentucky, Southwest Ohio, and part of West Virginia. The administration’s independent investigation uncovered negligence, contradicting the previous OPTN Board of Directors’ internal review, which had claimed to find “no major concerns.”
The HRSA reviewed 351 organ donation cases that were authorized but not completed and identified concerns in 103 cases. Issues included patients showing neurological signs incompatible with organ donation and patients who “may not have been deceased at the time organ procurement was initiated,” raising major ethical and legal concerns. The findings further revealed poor neurological assessments, inadequate coordination with medical teams, questionable consent practices, and misclassified causes of death, especially in overdose cases, according to the HHS.
Vulnerabilities were found to be greatest in smaller and rural hospitals, revealing systemic oversight gaps. As a result, the HRSA mandated strict corrective actions for the organ procurement organization under investigation, including a full “root cause analysis” of protocol failures — such as not observing the five-minute rule after death — along with the development of enforceable donor eligibility criteria. The organization must also implement a formal procedure allowing any staff member to stop the donation process if patient safety is in question.
The organ procurement organization will be decertified if it “fails to comply with these corrective action requirements.”
The HRSA directed the OPTN to strengthen national safeguards and monitoring to improve organ donation safety. Under this directive, all safety-related donation stoppages initiated by families, hospitals, or procurement organization staff must be reported to regulators. The OPTN must also update its policies to enhance organ procurement safety and ensure families and hospitals receive accurate, complete information about the donation process.
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