By Scott Dance, The Baltimore Sun
3:46 PM EDT, April 27, 2013
Maryland health officials may ask state lawmakers for permission to oversee plastic surgery centers, a move inspired in part by the death of a Lochearn woman after liposuction.
The state health department had already been considering whether to ask for a change to the legal definition of free-standing surgery centers to align regulations with medical risk instead of insurance billing practices, Secretary Joshua Sharfstein said. Surgical centers currently are subject to state inspection only if they meet certain criteria in how they bill insurance companies, he said.
The issue became a priority after three liposuction patients at Monarch Medspa in Timonium came down with aggressive infections, prompting health officials to temporarily close the facility Wednesday, he said. One of the patients died Monday.
"There's an unevenness, in a sense, to the level of regulation that applies," Sharfstein said. "Something like this makes us more interested in exploring this issue."
The department plans to seek public input before making any recommendations to the General Assembly.
While doctors and nurses who perform plastic surgery must be board-certified, the facilities where the procedures are performed are not always subject to inspection and other oversight. Insurance companies and the federal government require most surgical centers to meet standards of safety and infection prevention, but many plastic surgery centers deal with patients who pay out of their own pockets.
The three patients who underwent liposuction at the Timonium facility within the past month contracted infections of a bacteria known as group A staphylococcus, the state health department said. The bacteria is the same one that causes strep throat and other common illnesses but is rarer and more dangerous when infecting the skin and other body parts. The state said its inspectors observed "probable deviations from standard infection control practices" at the center.
Health officials began considering updates to surgical center regulations this spring during a review of abortion clinic oversight, Sharfstein said. Some public comments on that issue questioned why officials were looking at abortion clinics when there are other unregulated facilities performing different but equally risky medical procedures, he said.
While a state law specifically permits health officials to regulate abortion clinics, when it comes to other types of surgical centers, the code isn't as clear, Sharfstein said. That is why officials would need permission from the legislature.
State law defines what is called an "ambulatory surgical center" as a facility that performs outpatient procedures and "seeks reimbursement from payors as an ambulatory surgery center." Similar facilities where individual doctors send out the bills fall outside the scope of the legislation, Sharfstein said.
Some plastic surgery centers fall outside those regulations because they bill patients directly, but others may seek licensing or accreditation voluntarily, said Andrea Hyatt, administrator of Dulaney Eye Institute in Towson and president of the Maryland Ambulatory Surgery Association.
A state law passed in 2010 added some state oversight of plastic surgeons, but it did not address the surgery centers themselves. Under the law, the state Board of Physicians can discipline doctors who perform certain cosmetic procedures in unlicensed or unaccredited facilities. The law does not apply to liposuction procedures in which less than 1,000 cubic centimeters of fat are removed, or any procedures in which only local anesthesia is administered.
Monarch is not among the certified ambulatory surgical centers listed by the Maryland Health Care Commission and does not list any accreditations on its website. Company officials said Thursday that they did not have further comment. In a statement Wednesday they called the infections "a new development" and said they are working with health inspectors to investigate the source.
Accrediting organizations typically inspect facilities every two to three years to review safety and infection control procedures, said Dr. Salvatore DiMercurio, a Hagerstown plastic surgeon who is president of the John Staige Davis Society of the Plastic Surgeons of Maryland. That includes, for example, requirements to have emergency materials and medications in case of infections, and to throw away medications when they expire, DiMercurio said.
"If you don't have a governing body saying, 'I'm sorry, you need to throw this out and keep buying it,' you can cut some corners," DiMercurio said.
Del. Kirill Reznik, a Montgomery County Democrat who was the lead sponsor of the 2010 legislation, called discussions about oversight of plastic surgery centers worthwhile, but challenging.
"If we go down this path and we open that can of worms, we may delve into some areas that are going to be incredibly bureaucratic and may not provide any real change in terms of patient outcome," Reznik said.
Dr. Craig Vander Kolk, a plastic surgeon at Mercy Medical Center, said many plastic surgery patients may be attracted to facilities that only perform with local anesthesia because it seems safer than general anesthesia. But often, it can be riskier to undergo procedures in doctors' offices or operating rooms that haven't been accredited, he said.
Hyatt said she encourages patients to seek out information on centers' accreditations and licenses before undergoing any invasive procedures.
"Patients should feel free to ask," she said. "If you don't see it in the waiting room, you need to be asking questions."
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