Beginning this week, office surgery centers will be inspected by state investigators rather than independent auditors — a policy change by the Florida Department of Health that healthcare safety advocates say could harm patients, especially clients of discount cosmetic surgery clinics associated with repeated injuries and deaths.
The change will affect most of Florida’s estimated 535 licensed and active office surgery centers that perform a range of procedures every day, from removing warts and moles using little or no sedation to performing liposuction and fat transfers requiring general anesthesia.
State officials say they decided to cancel the contracts after “evaluating the relationship” with the independent auditors who have conducted the inspections since 2000.
The office surgery centers now will be inspected instead by the state’s Investigative Services Unit, which investigates complaints against doctors and hospitals, according to Brad Dalton, a health department spokesman. He would not say whether the move was a cost-cutting measure.
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“The department has full confidence in our Investigative Services Unit to conduct these inspections,” Dalton said.
538 Number of licensed, active office surgery centers in Florida
The investigative unit includes professional investigators and pharmacists. But Dalton said the health department has hired licensed registered nurses with surgery experience to inspect office clinics. He said the nurses will use tablets to convey information for a faster response to potentially dangerous situations.
In recent years, office clinics — where physicians sometimes perform six to eight hours of surgery with general anesthesia — have increased risks for patients, said Cheryl White, an independent contractor who has inspected Florida centers since 2000.
“That’s in an uncontrolled environment where the people who are taking care of the patients really need to know what they're doing,” White said.
Without ensuring that state inspectors have a background in risk management and clinical experience, White said, “It’s going to be a check-the-box inspection.”
Former Florida Sen. Eleanor Sobel, who unsuccessfully tried to pass a bill in 2016 to tighten state regulation of office surgery centers, said she worries that the state’s move away from independent inspectors will lead to lower standards of patient safety.
“It’s really important to have that independent oversight,” she said. “It protects the consumer. It protects the elected officials. It protects the doctors.”
White, a registered nurse and licensed healthcare risk manager, runs Total Pain and Risk Consultants — one of two independent contractors whose agents inspected office surgery clinics statewide until the change. The state canceled the company’s contract as of Jan. 9, along with the contract for RCS Consulting Group, the second independent contractor.
Florida Society of Plastic Surgeons offers guidance for consumers considering cosmetic procedures, including: Never go into surgery without a prior consultation with the surgeon. Make sure the informed consent agreement is very specific as to what procedures will be performed, down to the exact body part.
The Florida Board of Medicine created the Office Surgery Registration and Inspection program in 2000 to require that doctors performing surgery in their offices meet the same standards as hospitals and surgery centers.
The program, which was a response to a number of fatal operations, requires doctors to register with the state, submit to inspections and quickly report patient deaths and injuries.
But though it has the power to regulate office surgery centers, the Board of Medicine can only take action if an office surgery clinic is wholly owned by a licensed physician.
And the state’s other regulatory arm, the Agency for Health Care Administration, only oversees clinics that submit claims for payment from third parties, such as a health insurance company. Many office surgery centers take payments in cash or credit card only.
While the previous method of independent inspections caught problems, that didn’t always stop the clinics from operating.
In 2016, a Hialeah clinic continued to operate even after inspectors had found that physicians failed to properly monitor patients under general anesthesia and in some instances neglected to perform preoperative medical screenings in violation of state safety standards.
Four months after that inspection, a 29-year-old West Virginia woman suffered fatal complications from a fat transfer procedure at that clinic, Encore Plastic Surgery. The clinic continued performing cosmetic procedures even after the incident.
Sobel, the former state senator, said the onus is on consumers to check out their physicians and the clinics where they receive services — especially popular but risky procedures such as liposuction and Brazilian butt lifts.
“It’s safer to go to the hospital rather than have it in a doctor’s office,” she said.
Dalton, the health department spokesman, said the nurses hired to conduct inspections will be trained at office surgery clinics and also at ambulatory surgery centers that perform more complex procedures.
It’s really important to have that independent oversight. It protects the consumer. It protects the elected officials. It protects the doctors.
Former Florida Sen. Eleanor Sobel
White will be one of the trainers during the transition, she said.
Christopher Nuland, general counsel for the Florida Society of Plastic Surgeons, said the group believes the former inspectors were “doing an excellent job” and that “any interruption in the office surgery inspection program poses a grave danger to Florida's patients.”
“The society is concerned with the lack of inspection experience of the new hires but is encouraged that the state has opted to hire inspectors with medical training,” he said.
State laws do not require office surgery centers to be inspected if their physicians are accredited by a nationally recognized group, such as the Joint Commission on Accreditation of Healthcare Organizations. But those lacking accreditation must submit to annual inspections.