NJ sets benchmark to regulate office anesthesia

Specifies training, equipment, staff requirements

New Jersey set an ambitious goal for the rest of the country when it adopted well-defined, comprehensive regulations governing the administration of office-based anesthesia in 1998.

As greater numbers of surgical procedures that require anesthesia moved from ambulatory surgery centers to surgical suites within physicians’ office, patient safety has become a major concern for the Princeton Junction-based New Jersey State Society of Anesthesiologists, says Ervin Moss, MD, executive medical director of the society.

This concern led to a 15-year battle during which time opponents claimed that regulation of office-based anesthesia would lead to higher health care costs and the closing of some physician practices due to higher overhead costs.

"I don’t worry about the cost, I am concerned about patient safety," says Moss. He cites examples of deaths that occurred during procedures performed by a physician who administered anesthesia after viewing a 30-minute educational videotape as well as instances in which a anesthetized patients were given intravenous sedation by the office receptionist.

Although Florida and California have had regulations governing office-based anesthesia for three years, New Jersey’s regulations are stricter and better defined, says Moss. "The regulations address standards for training, monitoring equipment, staffing, and credentialing for physicians and staff members administering anesthesia," he adds. (See story on anesthesia regulations, below.)

Old equipment a problem

Out-of-date anesthesia machines are a big problem in many physician’s offices, explains Moss. Typically, a physician will purchase equipment that a hospital is discarding because it is out-of-date and doesn’t contain the most recent safety mechanisms, he adds. "The regulations define a safe machine and give physicians six months to update their machines to meet the standards," says Moss.

This doesn’t mean that physicians must purchase brand new equipment, explains Moss. "A refurbished machine with all of the up-to-date safety equipment costs about $20,000. When you add the monitors and defibrillator cart, the total comes to $50,000 to save lives," he adds.

Two other key areas addressed by the regulations include credentialing and reporting of untoward events. Basically, a physician may provide any service in the office that he or she is credentialed to provide in a hospital, explains Moss. If the physician is not credentialed on any hospital medical staff, there is an alternate credentialing process described within the regulations.

"A hospital has to report untoward events such as an injury, close call, or death that may be related to anesthesia, but we really don’t know what has been happening in physicians’ offices," says Moss. For this reason, he counts the mandatory reporting requirements contained in the regulations as one of the major benefits of his society’s efforts.

"We will now be able to collect data and evaluate patient safety related to anesthesia within a physician’s office," he explains.

Certified nurse anesthetists who provide anesthesia in an office setting must be certified by the American Association of Nurse Anesthetists in Park Ridge, IL, and be supervised by a physician who meets the criteria to administer anesthesia within the office. The New Jersey Association of Nurse Anesthetists is suing the New Jersey Board of Medical Examiners. The certified registered nurse anesthetists claim that their practice is a nursing practice and should not be supervised by an organization that licenses and oversees physicians. They also claim that their training should allow them to perform anesthesia in an office without anesthesiologist supervision.

Moss is pleased that the American Society of Anesthesiologists (ASA) in Park Ridge, IL, and the Society of Ambulatory Anesthesia (SAMBA), a subgroup of the ASA, are looking at the issue of office-based anesthesia. The ASA is developing practice guidelines, and SAMBA is providing education to surgeons, anesthesiologists, and patients through its Web site, says Marc E. Koch MD, a Whitestone, NY, anesthesiologist who serves as chairman of SAMBA’s Committee on Office-based Anesthesia.

"The numbers and types of procedures performed in office settings has grown rapidly and will continue to grow, so it is important for us to look at how practitioners can provide anesthesia safely," says Koch.

The guidelines underscore the fact that there should be one standard of care for all ambulatory anesthetics, whether in a surgery center, doctor’s office, or hospital-based ambulatory surgery program, says Rebecca Twersky, MD, president of SAMBA and member of the New York State Task Force on Office Surgery and Anesthesia.

SAMBA members are in the preliminary stages of developing protocols for an anesthesia outcomes study. They also are developing an article that will review current literature of office-based anesthesia, state-of-the-art anesthesia technology, legislation regarding office-based anesthesia, and patient safety issues a practitioner should take into account when providing office-based anesthesia.

Moss says that Medicare is forcing more procedures, such as those requiring only local or regional anesthesia, into office settings. He also points out that managed care organizations in New Jersey and other states have also attempted to limit certain surgical procedures to offices. (See story on insurance incentive, p. 6.)

For these reasons, Moss adamantly believes that state regulations are the best way to protect patient safety.

"Practice guidelines are helpful but they are not enforceable, and they are offered as advice only," he says. "Regulations are law, and a physician in New Jersey who doesn’t follow the regulations is committing a crime. This is the best way to ensure that any patient receiving anesthesia in an office setting will be safe."