What led Florida board to pass moratorium?
Florida has a history of closely monitoring office-based surgery. The Board of Medicine adopted rules relating to office surgery in 1994. Over the last two years, the board has developed additional standards of practice to try to increase patient safety.
Florida passed a law that became effective in March, which requires physicians to report adverse incidents that occurred in their offices.
In August, the board learned there had been 20 adverse incidents in Level III office-based surgeries this year in which patients had to be transferred to hospitals, and five of those patients died. Fifteen of the 20 adverse incidents related to surgical procedures, and nine of the 15 surgically related adverse incidents related to plastic or cosmetic surgery. The nine plastic/cosmetic surgery patients included four of the five patient deaths. The board was advised that the deaths were anesthesia-related and that the rate of deaths was higher than that occurring in ambulatory surgical centers, for which there were five reported deaths in 1999.
The board issued a 90-day moratorium on Level III office surgery, which is defined as surgery that involves, or reasonably should require, the use of a general anesthesia or major conduction anesthesia and preoperative sedation.
The board took the position that there was an immediate danger to the health, safety, and welfare of patients in the state. "The board does not believe it can just stand by while patients, many of whom are seeking elective procedures, die during surgery," said a released statement from the board.
The purpose of this moratorium is twofold, the board said:
• "First, to protect the lives of patients who would otherwise undergo Level III surgery in physician offices instead of in the more highly regulated hospitals and ambulatory surgical centers."
• "Second, to help the board and all of the physicians and other parties involved in office surgery to focus on the immediacy of the danger and to try to develop appropriate safeguards so that Level III office surgery can be performed safely in physicians’ offices or so that a record can be more thoroughly developed upon which a decision may be based as to whether or not Level III surgery is safe in offices."
"Many of these deaths were cases in which numerous procedures were being done at one time," says Lisa Tucker, MD, a member of the Florida Board of Medicine. "Also, the fact that there were so many deaths with whatever rules were in place suggested that the changes were needed."
The board established an independent Out-patient Surgical Care Commission to collect information about surgeries in offices, surgery centers, and hospitals and make recommendations at the end of the moratorium. The commission is addressing length of surgeries, amounts of liposuction, equipment necessary for proper anesthesia and monitoring, and the need for transfer agreements with hospitals, and guidelines for performing office procedures on American Society of Anesthesiologists Level III patients.
"We currently have a commission reviewing these cases, which we hope will help answer the questions of Why?’ and What can we do?’" Tucker says.
Reaction to the Florida moratorium has been mixed.
"I think in general it was a overreaction, which may serve to do more harm than good in the long run," says Marc E. Koch, MD, president and CEO of Resource Anesthesiology Associates, an anesthesiology practice, and physician director of the OR in St. Claire’s Hospital in New York City.
The moratorium could drive office-based surgery into being an "underground profession," Koch says. "If patients need liposuction or breast augmentation and can’t afford a hospital, they might do it in an office in a clandestine fashion."
Others say that a focus on safety will ultimately be good for the practice of same-day surgery.
"Patient safety is first and foremost," says Larry Hornsby, CRNA, president of the American Association of Nurse Anesthetists in Park Ridge, IL, and vice president of Anesthesia Resources Management, a Birmingham, AL-based group practice of anesthesia providers. "If Florida can come up with a system that will improve patient care, the system has worked."
Walter L. Erhardt, MD, president-elect of the American Society of Plastic Surgeons in Arlington Heights, IL, agrees. "Any patient adverse reaction, certainly any patient death, particularly with an elective procedure, is too many."
However, Erhardt says the Florida board reacted quickly before adequately analyzing the data. There are several checks and balances in place that help a patient determine a safe place to have surgery, he says. "I think it’s going to be very, very difficult to legislate good judgment. There’s absolutely no way you can expect the Florida Board of Medicine to do the job of a careful doctor and informed patients."
For more information on the Florida moratorium, contact:
• Lisa Tucker, MD. E-mail: [email protected].
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