The U.S. Department of Health and Human Services said Thursday it will "decertify" an organ transplant agency run by the University of Miami Health System, saying a federal investigation "uncovered years of unsafe practices, poor training, chronic underperformance, understaffing, and paperwork errors."
HHS said the Life Alliance Organ Recovery Agency, part of UM, is being decertified by federal officials.
"An organ procurement organization must serve as the trusted custodian of every donated organ," HHS Secretary Robert F. Kennedy Jr. said in a statement announcing the decision. "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."
Last year, UM's Life Alliance Organ Recovery Agency marked its 45th anniversary, according to its website.
UM Health System officials did not immediately respond to the HHS action when contacted by WLRN.
In their statement, HHS officials cited one case in which a surgeon mistakenly declined a donated heart for a patient awaiting transplant surgery. HHS did not identify the surgeon.
Almost 100,000 Americans are on transplant waitlists, say HHS officials, who note that 13 patients die daily awaiting an organ. More than 28,000 donated organs go unmatched annually.
UM is one of 55 "organ procurement organizations" nationwide designated by federal health officials as nonprofits responsible for coordinating the recovery of organs for transplants.
The OPOs work with hospitals to identify potential donors, obtain permission from families, and "ensure safe recovery of organs."
In its statement, HHS did not disclose additional details about its investigation of UM.
HHS Deputy Secretary Jim O'Neill said the Biden administration "turned a blind eye to systemic failures in the organ procurement system, closing investigations even when lives were at stake."
"Today, we are correcting those failures by restoring transparency and embracing forward-looking solutions to ensure every organ is used responsibly and every patient has a fair chance.," O'Neill said.
"CMS has a clear responsibility to ensure that every organ procurement organization meets the federal standards of safety, performance, and accountability," "For too long, patients and families have suffered from systemic failures.
CMS refers to the Centers for Medicare & Medicaid Services, which is part of HHS.
"We are enforcing rigorous standards and modernizing the system with better data, stronger oversight, and innovative tools to make organ procurement safer, fairer, and more effective for every American awaiting a transplant," said CMS Administrator Dr. Mehmet Oz said.
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