A state board sets limits on the procedures and demands more data on them from doctors.
By WES ALLISON
© St. Petersburg Times, published November 6, 2000
TAMPA -- After a 90-day hiatus, major office surgeries may resume in Florida this week, but the state Board of Medicine added new restrictions on some risky procedures and ordered doctors to submit more data about virtually all office surgeries.
At a special meeting Sunday in Tampa, the board approved a less restrictive emergency rule to replace the current moratorium on major office surgeries, which expires Wednesday. The new rule also includes reporting and risk management requirements.
"There's no reason there should be a lower standard of care in an office than a hospital or ambulatory surgery center," said Dr. Rafael Miguel, an anesthesiologist and board member from Tampa.
"We were trying to come up with something today we could implement immediately and then fine tune."
The tenets of the new rule were based on recommendations of the Commission on Outpatient Surgical Safety, which the board convened to address concerns that too many patients were injured or dying during surgery at doctors' offices, particularly during cosmetic surgery.
In the month before the moratorium, at least four people died during in-office cosmetic procedures. Two people have died in doctors' offices since then, but neither case was related to cosmetic or plastic surgery.
The emergency rule is good for 90 days, although board members say they plan to try to make most of its provisions permanent.
They affect doctors who provide office surgeries deemed level 2, in which the patient is sedated but conscious, and level 3, in which the patient is heavily sedated or asleep. These may include cosmetic surgeries as well as common dermatological surgeries or invasive tests, like colonoscopies and biopsies.
Among the new requirements:
No abdominoplasty with liposuction, and no liposuction combined with other procedures.
Elderly or sick patients cannot have level 3 surgery in an office.
Doctors must establish certified risk management programs similar to those required for ambulatory surgery centers and hospitals. Such programs are designed to find holes in safety procedures, find recurring problems, and help doctors fix them.
For one year, doctors must submit all surgical logs to the state Agency for Health Care Administration. This is designed to show the board how many surgeries are actually being performed, what kinds of surgeries are commonly done and what kinds of problems doctors face.
The 16-member outpatient surgery commission consisted of six plastic surgeons, six other doctors, three lay members of the board of medicine and a risk management specialist. Although the commission found evidence that patients do need more protection, it salted its report with a serious caveat: The state does not have enough information to draw any intelligent conclusions about office surgery.
Dr. J. Darrell Shea, chairman of the committee and chief medical officer for the Agency for Health Care Administration, likened records regarding office surgery to "a deep, black hole."
"We need to know all data, all surgery, even the tiniest lump and bump," Shea told the board of medicine.
Becky Cherney of Orlando, one of the three non-doctors on the board, said the new reporting requirements are "way overdue."
"Office surgery is a rapidly expanding part of the business," she said. "Ten years ago, 20 percent of these procedures weren't being done outpatient."
State Secretary of Health Robert Brooks, who doesn't usually attend the board of medicine meetings, commended the board for increasing scrutiny on outpatient surgeries, which he said are expected to number 100,000 in Florida next year.
Doctors who attended Sunday's meeting grumbled about the new restrictions but generally said they could live with them, and the Florida Medical Association said it likely will not fight them in court.
Dr. Dean Johnson, president of the Florida Society of Plastic Surgeons, said he can support the restrictions "until all the safeguards can be put in place."
"It doesn't hurt our patients' access to care," he said. "That's what's good about it."