New bill would keep office surgeons in check -- but is it enough?

In 1997, when Judy Loveless went to Luna Laserperfect Skin Center in Buckhead to have some wrinkles around her eyes and mouth removed, she had no idea that she was the spa's first patient. You could say that Loveless, a petite, attractive flight attendant for Delta, was flying blind.
So was her doctor, Daniel Kim, an ophthalmologist with no formal training in anesthesia administration. After hooking her up to an I.V. and putting her under mild sedation, he went to work. He didn't notice for several minutes that Loveless was barely breathing. After all, he was operating alone and his patient wasn't hooked up to any monitoring devices.
When he realized there was a problem, he called in staff members, who attempted CPR. They called 911. Paramedics came 25 minutes later, their arrival delayed by a driveway too narrow to fit an ambulance and elevators too small to fit a gurney. By the time Loveless got to St. Joseph's Hospital, she was dead.
Now, the state's General Assembly is poised to consider a bill designed to prevent another case like Loveless'. The bill, sponsored by Rep. Garland Pinholster, R-Ballground, would require that office-based surgical settings be accredited. Physicians could perform only those procedures for which they have credentials from a hospital or the state. And, in case of mishap, the case would have to be reported to a peer organization within 30 days. Some physicians are calling the Office-Based Surgery Quality of Care Act of 2001 a crucial first step in regulating a high-risk area of medicine that now has little governmental oversight.
If such a law had been in place back in 1997, Luna Laserperfect would have been required to have a crash cart with resuscitative devices and drugs nearby, as well as machines to monitor Loveless' breathing and heart rate. An anesthesia provider would have been present for any surgery requiring sedation. And in case of an emergency, the spa's entryways would have been wide enough for an ambulance and gurney.
But would such a law have saved the life of Judy Loveless? After all, Kim would still not have been required to have any additional training in surgery, anesthesia or cardiac life support. Such skills are crucial if a deteriorating patient needs emergency care before paramedics arrive.
What's more, the bill calls only for persons "licensed" in providing anesthesia, a vagueness that allows doctors to rely on assistants who may not have enough expertise to perform or assist in some complicated, high-risk procedures. When both doctor and anesthetist have only superficial training in anesthesia, medical crises that arise in office surgicenters can quickly turn tragic. In fact, the three Atlanta women who died in the last several years while undergoing plastic surgery in private offices experienced anesthetic complications that seemed to overwhelm the surgical teams suddenly faced with saving their lives.
"There is a whole lot of surgery going on in Georgia with CRNAs (certified registered nurse anesthetists) administering anesthesia without adequate supervision," says Dr. Steve Sween, an anesthesiologist at St. Joseph's Hospital. "I don't think this bill will change that."
Sween, chair of governmental affairs for the Georgia Society of Anesthesiologists, believes general anesthesia should be administered only by or under the supervision of an M.D. anesthesiologist, like himself. But, recognizing that there aren't enough anesthesiologists to go around, he will push the Legislature for the next-best thing: to amend the bill so that anesthesia providers must at least be board certified (a tougher standard than licensing).
He expects resistance from some doctors. "It's controversial," he says, "because it eliminates the idea many surgeons have that they can operate any time, any place, any way they want to, and that they don't have to be responsible for anesthesia and complications that occur under their watch."
Some doctors worry that the standards could be too stringent. "It is folly to put in a credentialing requirement for procedures that were developed as outpatient procedures," says Dr. Harold Brody, a board-certified dermatologist. Brody fears that dermatologists who perform liposuction and laser procedures using mild sedation might now be told they have to stop, because of "the bias that many hospital-based physicians have against certain medical specialists." Brody also anticipates that ophthalmologists and otolaryngologists who perform facial plastic surgery will see business suffer.
"I think this provision will put an unfair restraint of trade on a number of physicians who are perfectly qualified to do surgical procedures in their offices," he says.
But advocates of the bill say the combination of credentialing and peer review requirements in the bill would make it tougher for surgeons with inadequate training to keep operating.
"If your cases and your practice are being reviewed on an ongoing regular basis, the hospital peer review committee will zero in on your weaknesses," says Dr. Daniel DeLoach, a Savannah plastic surgeon who chairs the Medical Association of Georgia's outpatient surgery committee. "If you've got a high complication rate, you will be found out, and if you don't improve, you'll risk losing your credentials. Your ability to dodge, cloak and hide problems is greatly reduced under that kind of scrutiny."
One missing element in the proposed bill is a mechanism for automatically reporting severe incidents to the state. By relying instead on a review by a doctor's peers, which is confidential, the new regulations do not ensure that all deaths, serious injuries and doctor misconduct will be reported to or investigated by the state board of medicine.
In fact, the policy could result in a decrease of such reports. "Keeping the board of medicine out of the reporting loop is a big mistake," says David Swankin, executive director of the Citizen Advocacy Center in Washington, D.C., a nonprofit organization that works for more patient protection by state medical boards. "If you keep the main player out of it, who will enforce these regulations? Peer review is good in conjunction with state oversight, not as a substitute for it."
But DeLoach says peer review could actually speed up the process by which doctors are disciplined.
In the Loveless case, Kim's negligence was so clear that his medical license was revoked immediately by the Composite State Board of Medical Examiners; his attempts to have it renewed since then have been unsuccessful. Relatives of Loveless sued Kim and the owners of the spa for malpractice and wrongful death. They received $3.5 million in an out-of-court settlement in 1998.
But most cases aren't so public or dealt with so quickly. A medical board often must wait years for lawsuits to be resolved before it can take action against a doctor. That's because state law says the board must investigate only those malpractice cases with judgments or settlements of $100,000 or greater.
If the new measures were in effect now (if approved, they would kick in next July), the most serious cases would go straight to a peer review committee. If the committee found that a doctor was grossly negligent, it would have to report its findings to the board of medicine, DeLoach says.
Take the case of 48-year-old Jeannie Huff, an interior designer. In February 1999, she went to the offices of Dr. Harvey "Chip" Cole, an oculoplastic surgeon, for a face and brow lift. Earlier, Huff had specified that she wanted an M.D. anesthesiologist to administer the anesthesia, rather than a nurse anesthetist. But Cole instead relied on a CRNA. (In court papers, Cole claims Huff verbally approved the switch; her husband, Louis, claims she did not.)
About an hour into the surgery, Huff's blood pressure and pulse dropped sharply. While Cole hastily sutured Huff's forehead, the nurse, Gary Foti, administered a series of injections. Paramedics arrived and rushed Huff to St. Joseph's Hospital. Huff had several brain seizures and lapsed into a coma. She died on Valentine's Day, 1999. Louis Huff is suing Cole and Foti for malpractice and wrongful death.
In court exhibits, Cole says Huff's death was due to "a very rare drug reaction." He sent Louis Huff a doleful note and a copy of "When Bad Things Happen to Good People." Cole even asked to attend Huff's funeral, but the family said no.
In their legal responses, both Cole and Foti deny they acted negligently. Cole also argues that even if Foti was negligent, he — Cole — was not. Cole says he can't be held responsible for the failings of his anesthesia provider, who was "an independent contractor."
Unlike Kim's, Cole's facility was accredited. He also held surgical credentials. And although Cole has no formal training in anesthesia, such training isn't required under the proposed law. So, Cole may be able to skirt punishment in civil court, and thus fly under the radar of the medical board.
But under the proposed law, the death would have to be reported to a peer review committee within 30 days. The committee might judge Cole more harshly than the medical board, and sanction him sooner, yanking his credentials. In any case, the committee could pressure Cole to make necessary changes to his practice to improve patient safety.
Sween is one of the physicians who'd like to see doctors have to answer sooner for their mistakes.
"If the physician is not held responsible for anesthetic mishaps under his supervision, then that means he could do even more complicated and risky surgeries in his office and continue to let the people who assist him take the heat when things go wrong. I don't think the law lets a surgeon get away with that. And I'm sure a peer review committee wouldn't."
Cole, who is one of a dozen doctors on the medical association committee who helped draft the new office surgery bill, declined through a publicist to comment for this story, citing the ongoing litigation.