Cosmetic laser clinics bristle at physician oversight mandate

OLYMPIA – Three years ago, a 24-year-old woman named Suzanne walked into a Bellingham laser skin clinic to have a small tattoo removed from her arm.

What happened on her second treatment, according to a complaint her mother filed with state medical officials, sounded less like a cosmetic procedure and more like an industrial accident.

“There was (the) smell of burning flesh, skin being burned and falling from Suzanne’s arm,” the complaint letter reads. “The skin looked as though a V-shaped carving knife was used to etch through the tattoo.” Instead of a tattoo of two theatrical masks, photos submitted to state investigators show large, puffy scars – shaped exactly like two theatrical masks.

State health officials investigated. The nurse who ran the clinic was ordered to cease laser use for 10 years, fined $1,000, ordered to take ethics classes and had her nursing license put on probation for a year.

Such complaints are rare, according to several years’ worth of state health records examined by The Spokesman-Review. But state medical officials say they’re not rare enough.

Starting in March, Washington’s fast-growing cosmetic laser industry will fall under a new state rule requiring all medical lasers to be used under the supervision of a doctor or physician’s assistant. A doctor or physician’s assistant will have to do the initial exam, and a doctor must be available within an hour if something goes wrong.

In some ways, the new rule is just a more explicit version of existing law. But state regulators say it’s aimed at ensuring that people using lasers have meaningful medical supervision.

“It was regulated, but the practitioners had no direction,” said Beverly Thomas, program manager for the state Medical Quality Assurance Commission, which approved the rule.

In investigating complaints, “we found that for a lot of physicians, their name was on the business and they never went there,” she said. Some supervising doctors weren’t even in Washington.

The new rule – which has been in the works for two years – is unpopular among some laser clinic owners. State estimates put the cost of hiring a physician’s assistant or doctor at between $56,000 and $204,000 a year. Not surprisingly, many laser clinic owners think it’s regulatory overkill and a money grab by doctors interested in a lucrative, cash-only sideline.

“If you’re properly trained, you don’t have to be a doctor or a nurse,” said Debbie Caddell, owner of two Caddell’s Laser and Electrolysis clinics in Bellevue and Seattle. Her staff, which includes a part-time physician’s assistant, uses six lasers. Most of the work done is hair removal.

Caddell, an electrologist for 26 years, agrees there should be state standards. She said she and other reputable clinics cringe at some of the inexperienced staff at some laser clinics.

But her staff is fully trained by laser manufacturers and many take additional classes through a Colorado school, she said. Under the new rules she would probably have to hire another physician’s assistant, she said. Instead, she may have to close her Seattle shop.

“It’s not that regulation is not necessary,” she said. “But they’re treating this like it’s surgery.”

“Our technicians aren’t very thrilled. They’re worried about their jobs,” said Michelle LeBlanc, clinic manager for American Laser Center in Spokane Valley. She said the year-old clinic has never had a patient with an adverse reaction to the treatment.

And complaints about injuries do seem rare. A check of court records in Spokane found just one involving a laser clinic. The now-defunct Nuvo of Northtown was sued by a Pend Oreille County man named George Blair, who said he suffered facial burns in 2004. Court records include few specifics, except that the suit was settled in 2005. Efforts to contact Blair were unsuccessful.

Caddell said she and other laser clinic owners plan to make their case to state legislators in January, pushing for a new law allowing trained staff to use the devices.

“We think it’s a turf war,” she said. “History is repeating itself. When electrolysis first came out the doctors took it; and 10 years later they gave it back.”

Although the state’s been fielding complaints about poorly supervised laser clinics for years, the commission began writing the new rule at the behest of Dr. Samuel Selinger, a Spokane cardiovascular surgeon. He’s been a state Medical Quality Assurance Commission member for five years.

Selinger said he was approached by an Idaho dermatologist who told him a Spokane-area shop had mistakenly lasered a patient’s cancerous melanoma.

“He commented that that wouldn’t have happened in Idaho,” Selinger recalls. The danger, Selinger and Thomas said, is that the laser treatment can trigger faster growth of the cancer.

Critics of the new rule, Selinger said, have contended lasers are used largely for “just hair removal.” But hair goes all the way through the skin.

“So when you’re talking about hair removal, you’re not talking about a superficial layer of the skin,” Selinger said.

Since at least 2002 the commission’s policy has stated that using a prescription laser to treat or alter skin means the user is practicing medicine. But use of the skin lasers – most commonly used for long-term hair removal – could be delegated, “provided a physician provides appropriate oversight.”

But as more and more laser skin care centers crop up in malls, spas and health clubs, state medical regulators worry about how much physician oversight is taking place. The commission repeatedly has issued cease-and-desist orders to shops with little or no medical involvement.

“The issue of the lack of appropriate supervision … is showing up in cases as a recurring issue,” one state attorney wrote to another during an e-mail discussion of a 2003 Yakima complaint over a doctor allegedly issuing clinic staff prescription pads with her name rubber-stamped on the signature line. “Too often, physicians are not on-site.”

In several recent complaints investigated by the state, physicians were paid a fee – typically $500 a month – to allow their name to be put on laser clinics’ paperwork for loans and leases. But they were rarely on-site. Some were hours away. And as soon as the state began investigating a complaint against the clinic, the doctors – almost invariably – quit.

Here’s a sampling of the complaints, as turned up by a months-long Spokesman-Review public-records request to the state Department of Health. Most were triggered by anonymous complaints.

“A Yakima doctor listed as “medical director” of a Yakima laser clinic in 2001 and 2002 “did not provide appropriate oversight” to laser staff and allowed them to issue prescriptions stamped with her signature. The doctor “never saw the patients,” a state report found. She was reprimanded by state health officials and fined $2,000.

“A nurse-run clinic in Vancouver “falsely advertised that there were physicians and surgeons” working there and repeatedly performed laser treatments without physician oversight in 2000 and 2001. The nurse was fined $1,000, her license was put on probation for three years, and she was ordered to work only under a doctor’s direct supervision.

“A woman with no Washington health credentials ran a laser in 2003 at a Vancouver day spa. She was ordered to stop and fined $1,000.

“Three other women with no Washington health credentials used a laser on patients at a Tukwila skin rejuvenation clinic in 2002 and 2003, leaving some with welts, blisters and severely ingrown hairs. They also were ordered to stop and fined $1,000.

The doctor listed as the medical director for the clinic told state health investigators that he “was paid primarily to compensate him for the risk of putting his name on the lease” for some of the clinic’s lasers. The pay: $500 a month. He resigned immediately when a state health investigator called him with questions about his role.