The U.S. Department of Health and Human Services (HHS) announced on September 18, 2025 that it is moving to decertify a major organ procurement organization (OPO) after an investigation reportedly uncovered years of unsafe practices, poor training, chronic underperformance, understaffing, and paperwork errors. In one 2024 case, a mistake led a surgeon to decline a donated heart for a patient awaiting transplant surgery.
CMS’s decertification of the Life Alliance Organ Recovery Agency, a division of the University of Miami Health System, is part of an HHS investigation into another OPO found that at least 28 patients may not have been deceased at the time of organ preparation, 73 patients showed neurological signs incompatible with donation, and an investigation was closed without action.
HHS stated that this systemic disregard for the sanctity of life within the nation’s organ transplant system poses a grave threat to both prospective donors and recipients. Nearly 100,000 Americans are currently on transplant waitlists, and an average of 13 patients die each day waiting for an organ, even as more than 28,000 donated organs go unmatched each year.
Secretary Robert F. Kennedy, Jr. stated in the HHS announcement: “An organ procurement organization must serve as the trusted custodian of every donated organ. Its job is to honor the gift of life by ensuring trained professionals recover every organ safely, match it fairly, and deliver it quickly to the patient who needs it most. We will not allow any participant to cut corners with human life, and we hold every institution in the transplant system to the highest standards of safety and accountability.”
Secretary Kennedy is directing all OPOs to appoint an OPTN Patient Safety Officer to oversee patient safety. These officers will be responsible for monitoring and investigating patient safety events in real time, serving as the first point of contact for families, hospital partners, and HRSA, documenting and reporting incidents and adverse events to OPTN, leading root cause analyses, and ensuring corrective actions are implemented. “This reform will lead to safer, fairer, and more reliable organ procurement, while strengthening accountability and preventing repeat failures.”
Organ Procurement Organization (OPO)
An Organ Procurement Organization (OPO) is a federally designated nonprofit responsible for coordinating the recovery of organs for transplantation in the United States. Each of the 55 OPOs serves a specific geographic region, working with hospitals to identify potential donors, evaluate medical suitability, obtain authorization from families, and ensure safe recovery of organs. They then match and allocate organs through the national Organ Procurement and Transplantation Network (OPTN). OPOs are regulated by the Centers for Medicare & Medicaid Services (CMS) and overseen by the Health Resources and Services Administration (HRSA) at HHS, with the mission of turning potential donations into successful transplants while upholding the highest standards of safety and accountability.
If you or a loved one suffered serious injury or other harms as a result of medical negligence involving an organ transplant in the United States, you should promptly consult with a transplant malpractice lawyer in your state who may investigate your transplant malpractice claim for you and represent you in a medical malpractice transplant case, if appropriate.
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