Florida opens loophole in office surgery rule

Nurse anesthetists may sedate patients if doctors win a waiver from state regulation requiring presence of an anesthesiologist.

By Myrle Croasdale, amednews staff. Aug. 12, 2002.

Plastic surgeons in the Sunshine State could soon be back to doing tummy tucks and face lifts in their offices.

Many had to move their surgeries to hospitals or hire an anesthesiologist as of April 15 when a Florida Board of Medicine regulation took effect, requiring the presence of an anesthesiologist for complicated office surgeries.

Winning a waiver
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Region: South

However in late July, nurse anesthetists and several physician groups fighting against the restriction were given a reprieve when the board released a set of criteria physicians and their offices need to meet to be considered for a waiver from the anesthesiologist requirement.

Chris Nuland, legal counsel for the Florida Society of Plastic Surgeons, said the guidelines would uphold patient safety while restoring the use of physicians' private operating suites.

"I think the board's action this past weekend strikes a good balance in accessibility [to office surgery] and optimum patient safety. The anesthetists think it's too loose, and the CRNAs think it's too tight, so it may just be right," Nuland said.

Until April, any medical doctor could supervise a certified registered nurse anesthetist during surgery.

Fees for anesthesiologists in Miami are 25% more than for nurse anesthetists.

"Since April 15, physicians have had two choices," Nuland said. "First, they can move their level IIIs to more expensive hospitals or ambulatory surgical centers or use more expensive anesthesiologists in their offices. Second, they can try to do the procedures under a level II anesthetic, increasing patient discomfort. None is an ideal option."

Douglas Dedo, MD, an otolaryngologist in Palm Beach Garden, Fla., said he was opting for lightening the sedation level for his patients.

"I've had to change from doing my surgery under general in the office to doing it under sedation," he said. "It's not as comfortable for the patient or for the surgeon."

He expects many physicians will do what he plans to do: win a waiver from the state's Board of Medicine.

"I will do my best to get a waiver to do general anesthesia in my office," Dr. Dedo said.

"We feel comfortable and competent doing it and have been doing it for years. We need anesthesiologists, but we're doing cosmetic surgery on healthy people, not class III patients [those with health problems]."

The Board of Medicine will have 90 days to review each waiver request.

The board will have 90 days to review each waiver request. Florida has regulated in-office surgeries since 1994, but it was a series of newspaper stories in 1998 and 1999 that revealed hundreds of injuries were taking place and many deaths, some directly linked to anesthesia.

A 90-day ban on all office surgeries was instituted in 2000, followed by legal battles over permanent patient safety regulations.

The Florida Dept. of Health said there are 225 physicians and 161 physician offices registered to perform level III office surgery.

Supervision is key

Enrique Fernandez, MD, president of the Florida Society of Plastic Surgeons, said the goal of the Board of Medicine was to allow surgeons who can demonstrate their competency to supervise a nurse anesthetist to do so, enabling them to use general anesthesia in their offices.

"We believe the vast majority of our members will be able to comply with this," he said. "We do recognize they have varying backgrounds in training, and the proposal would allow individuals to make their case before the Board of Medicine."

The 250-member FSPS estimates 27,000 level III surgeries are done in Florida physician offices annually. Nuland based that figure on surgical log reports released by the Florida Dept. of Health. He also cited an independent study that showed accredited physician offices had only one death out of 54,000 patients, the same as statistics from the Joint Commission on Accreditation of Healthcare Organizations on deaths from all causes at inpatient facilities.

However, the Florida Society of Anesthesiologists said there had been deaths from office surgeries since the new rule was put in place in April and cited statistics showing a death rate from level II and level III in-office surgery in Florida was 1 in 10,000, compared with 1 in 100,000 at ambulatory surgical centers.

James Jacque, MD, president of the Florida Society of Anesthesiologists, said that while a shortage of available and affordable anesthesiologists had been cited as a reason for loosening the requirement of having one present during complicated office-based surgeries, his organization had not received any requests from surgeons looking for anesthesiologists.

He said anesthesiologists in Miami-Dade County cost 25% more per hour than nurse anesthetists, which he didn't consider prohibitive.

Dr. Jacque said the aim of the Board of Medicine's new regulation was to elevate care at offices to those at hospitals and ambulatory surgery centers, but the guidelines for obtaining a waiver undermined the goal.

"Merely showing that a physician has had no problems with patient safety with 250 level III surgeries or has had 40 hours of CME doesn't necessarily show clinical competence in anesthesiology," he said. "Clearly the guideline options have fallen short of our mark."

ADDITIONAL INFORMATION:

Winning a waiver

Florida surgeons who want to do office surgeries requiring level III sedation must show an overall competency to supervise anesthesia. These recommendations include:

Physician is certified by a Board of Medicine-approved board.
Physician is assessed as competent to supervise a certified registered nurse anesthetist by a university-based medical school.
CRNA and physician have advanced cardiac life support certification.
Physician has continuing medical education hours in office-based anesthesia and his/her office-based specialty.
Physician has passed the competency exam at the conclusion of CME taken in a medical school setting.
Physician has completed a three-month full-time anesthesia program at a university teaching hospital.
Physician has completed 500 surgeries involving CRNA supervision, at least 250 of which involved level III surgeries during a two-year period. Also, 20% of these 250 cases should be reviewed by a board-approved risk manager.
The board will also take into consideration any adverse incidents in the prior two years, licensure status, disciplinary status, medical malpractice history, financial responsibility, education, board certification and hospital privileges.