The Department of Health and Human Services (HHS) said it is moving to shut down a major organ procurement organization amid actions to reform the nation’s organ transplant system.
The HHS said an investigation uncovered “years of unsafe practices, poor training, chronic underperformance, understaffing, and paperwork errors.”
If completed, the move would mark the first time the federal government has decertified an organ procurement organization.
“We are acting because of years of documented Patient Safety Data failures and repeated violations of federal requirements, and we intend this decision to serve as a clear warning,” HHS Secretary Robert F. Kennedy Jr. said.
The agency is moving to close Life Alliance Organ Recovery Agency, a division of the University of Miami’s health system. Kennedy said the organization “has a long record of deficiencies directly tied to patient harm.”
The organization can appeal the decision.
The Association of Organ Procurement Organizations said the Life Alliance Organ Recovery Agency serves 7 million people across six counties in south Florida and the Commonwealth of the Bahamas.
The Life Alliance organization is one of 55 organ procurement organizations across the country.
They are federally designated nonprofits responsible for coordinating the recovery of organs for transplantation in the U.S., focusing on specific geographic regions, working with hospitals to identify potential donors, evaluate medical suitability, obtain authorization from families, and ensure safe recovery of organs.
“An organ procurement organization must serve as the trusted custodian of every donated organ,” Kennedy said in a statement. “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.”
Kennedy said staffing shortfalls alone at the Miami organization may have caused as many as eight missed organ recoveries each week.
The decertification comes as a broader investigation earlier this year found what Kennedy said were “horrifying” problems at an organ procurement organization serving Kentucky, southwest Ohio and part of West Virginia.
According to the HHS, at least 28 patients may not have been deceased at the time organ procurement was initiated.
“We’re going to be tougher than ever before because if we lose trust in the organ transplantation system of this country, tens of thousands of people are going to die yearly whose lives could be saved,” Centers for Medicare and Medicaid Services Administrator Mehmet Oz said.
“We are sending a tough message to all the other nonprofit organ procurement agencies organizations … we want them to know there’s a new sheriff in town, and we’re coming for them if they don’t take care of the American people,” Oz said.
