HHS Decertifies Florida Organ Transplant Agency Over ‘Patient Safety’ Concerns

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WASHINGTON—The Department of Health and Human Services (HHS) has for the first time decertified an organ procurement group mid-cycle, addressing patient safety concerns as part of a move to root out unsafe practices in the organ transplant system that could cost patients’ lives.

“Every American should feel safe becoming an organ donor and giving the gift of life, yet decades of ignored patient safety concerns have driven more and more Americans off the donor list,” Health Secretary Robert F. Kennedy Jr. said at a news conference.

He said the department is acting on “years of documented patient safety data failures and repeated violations of federal requirements,” and the decision serves as a “clear warning” for other transplant procurement networks.

The targeted organization is the Life Alliance Organ Recovery Agency (LAORA), a division of the University of Miami Department of Surgery and one of 55 federally authorized nonprofits that allocate organs for transplant.

Founded in 1978, LAORA received accreditation from the Association of Organ Procurement Organizations in 2006. According to the Florida nonprofit’s website, it serves 7 million people across six counties in South Florida and the Commonwealth of the Bahamas.

An investigation into the decertified Florida organization “uncovered years of unsafe practices, poor training, chronic underperformance, understaffing, and paperwork errors,” an HHS statement said.

Dr. Mehmet Oz, administrator of the Centers for Medicare and Medicaid Services, echoed Kennedy’s concerns.

“We’re coming for them if they don’t take care of the American people,” Oz said.

Kennedy said his department will reform the Organ Procurement and Transplantation Network and invest in new ways to encourage organ donations.

At the briefing, Kennedy shared the story of his nephew, who died in May at age 20 after a lifetime of cerebral palsy. His family donated his organs, ultimately saving the lives of seven people, including a nine-year-old boy and the mother of a child with a disability.

The Association of Organ Procurement Organizations, of which LAORA is a member, thanked Kennedy for “conveying the healing power organ donation brought to his family and thousands of other families across the nation.”

The association said it will “continue to support the team at Life Alliance to ensure South Florida organ donors, transplant patients and their families have access to organ donation and transplantation services.”

It added that as “advocates for the patients and donor families,” the organ procurement organizations, or OPOs, are “committed to and invested in the ongoing improvement of our nation’s organ donation and transplantation system.”

LAORA said it will not appeal the HHS decision and “will cooperate fully with HHS to ensure a smooth transition.”

“We hope that other OPOs follow suit in putting patients first. Our focus remains on protecting the dignity of donors, supporting their families, and advancing the life-saving mission of organ transplantation,” a spokesperson for LAORA told The Epoch Times in a statement. It said its top priority has “always been safe, respectful, and compliant organ donation practices.”

“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,” HHS said.

Kennedy has asked organ procurement organizations to appoint a full-time patient safety officer to monitor and investigate patient safety concerns in real time.

Jim O'Neill, HHS deputy secretary, said the agency is committing $25 million to making living donations easier and more affordable. The funding will reimburse living donors for certain nonmedical expenses such as lost wages, travel, lodging, and meals, he said at the briefing.

In addition, the Advanced Research Projects Agency for Health, which operates under the HHS, is developing bio-printing technology to “3D print personalized organs on demand,” O'Neill said.

FDA Commissioner Marty Makary said his department has been changing requirements that slow down the organ delivery process, such as routine tuberculosis testing. He also said his department is looking out for signs of potential organ trafficking.

“We don’t have jurisdiction over what happens in other countries, but we have had complaints that other tissue products from individuals that may have been involved in forced organ transplantation against their will may be showing up in U.S. markets, including bone grafts or other tissue derivatives,” he said.

“We want to be responsive. There have been forced organ donations in other countries, on vulnerable populations, and it’s wrong, it’s evil, it’s dark.”

Makary said the administration will take further action if necessary.

“If we find out that any of that is in fact happening, we will shut it down and use the full extent of the law to punish that sort of activity,” he said.

“In China, forced organ harvesting of prisoners has continued for over 20 years. To affirm the sanctity of human life, America must sever its ties with China’s organ transplant system,” it said.

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