Overview

• CMS initiated decertification of the Life Alliance Organ Recovery Agency, a University of Miami division, marking the first federal move to remove an organ procurement organization midcycle, and the agency can appeal.
• Federal investigators cited unsafe practices, poor training, chronic underperformance, severe understaffing and paperwork errors, with HHS estimating a 65% staffing shortfall that may have led to about eight missed organ recoveries each week.
• AOPO said Life Alliance serves roughly 7 million people across six South Florida counties and the Bahamas, and stakeholders stressed the need to maintain uninterrupted donation services during the process.
• HHS paired the enforcement with systemwide reforms, including an independent OPTN board, mandatory patient-safety officers at all OPOs, and a public dashboard to flag out-of-sequence allocations and enable direct reporting.
• A July HRSA review of 351 halted donation cases at another OPO found nearly 30% with concerning features, including 73 patients with neurological signs incompatible with donation and at least 28 who may not have been deceased when procurement began.