Three major hospital systems argue new state proposal lacks safeguards for patient care.
Three of Florida’s largest hospital systems have filed legal challenges against a new state rule proposed by the Agency for Health Care Administration (AHCA) concerning the approval and oversight of organ transplant programs.
Tampa General Hospital, UF Health Shands Hospital in Gainesville, and Jackson Memorial Hospital in Miami allege that the proposed rule, issued in August, does not include adequate quality-of-care safeguards.
The hospitals, which perform a high volume of heart, liver, lung, and kidney transplants, argue that the rule would jeopardize patient safety.
Tampa General’s petition, filed with the state Division of Administrative Hearings, states that the proposal “does not require an organ transplant program to perform a minimum number of transplants each year” nor does it establish a “minimum outcome standard.” This, according to the hospital, could allow low-volume programs with minimally experienced staff to operate without consequence.
A joint petition from UF Health Shands and Jackson Memorial raises similar points, expressing concern that the potential “proliferation of low-volume, low-quality programs” could “endanger existing programs” by drawing away patients, which could impact the viability and quality of care at established centers.
The legal challenges follow a years-long debate over transplant program regulation, which began after the state repealed the “certificate of need” process in 2019.
The hospitals contend that with the elimination of that process, the new licensure standards are now the sole governing authority and must be robust enough to ensure patient safety and quality. The current dispute marks the second time a proposed rule on this matter has drawn opposition, with a previous proposal being withdrawn in 2021.
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