Setting Standards for Practice
Part of the difficulty in establishing regulations on procedures done in physicians' offices is that while hospitals and ambulatory surgical centers are regulated by each state's department of health, physicians and their private offices are regulated by the state's board of medical examiners. Historically, physicians practiced individually and only performed consultations or treated minor ailments in their offices. Therefore, physicians' office-based practices were not subject to the same extensive regulations as hospitals and ambulatory surgical centers were. To make the same standards of safety apply in physicians' offices, regulations must be passed by each state's board of medical examiners or equivalent agency with supervisory authority over physicians. An alternative is for state legislatures to pass laws that mandate practice standards for office-based settings.
New Jersey, New York, and Florida have all attempted to establish standards of practice to reduce outpatient medical errors, with markedly different outcomes. The New Jersey Board of Medical Examiners implemented regulations that established standards of practice for outpatient office-based surgery and included a mandatory reporting requirement for adverse events and complications. Based on the apparent success of the New Jersey regulations, the New York State Senate developed a task force to draft legislation regulating office-based surgery. Alarmed by the number of adverse events resulting from office-based procedures, the Florida Board of Medicine imposed a ninety-day moratorium on Level III office-based surgery (defined as surgery that involves the use of general anesthesia or major conduction anesthesia and preoperative sedation) from 4 August to 8 November 2000 so that the safety of these procedures could be evaluated and regulations could be developed.
Rather than working with the state legislature to implement standards for office-based surgery, advocates worked with the New Jersey Board of Medical Examiners. The goal was to encourage the board to mandate standards for office-based care. The office regulations went into effect in June 1998. By implementing standards identical to those for hospitals and ambulatory surgical centers, New Jersey created a uniform standard of care regardless of inpatient or outpatient status.
The standards address the areas of patient monitoring during procedures, technology implementation, and equipment purchase and maintenance. General anesthesia can be administered only by anesthesiologists or nurse anesthetists working under the direction of an anesthesiologist. To practice in an office, an anesthesiologist must have admitting privileges at a nearby hospital. Certain physician groups protested this provision, stating that they exclusively practice in offices and do not want to obtain hospital privileges, so an alternative credentialing system is still being developed. Obsolete machinery must be replaced, maintenance must be performed by the manufacturer on schedule, and patients must be carefully monitored while under general anesthesia and while in the post-anesthesia care unit (PACU). Equipment replacement was mandated to ensure that hospitals, ambulatory surgical centers, and office-based practices invested funds in replacing the machinery. Additionally, a mandatory reporting system was created. Physicians are responsible for reporting any deaths, complications, or adverse events that occur during office-based procedures.
In February 1999 the New York State Senate Committee on Investigations, Taxation, and Government Operations convened a committee to study problems of office-based surgery. The investigation was conducted as the New York State Public Health Council simultaneously drafted clinical guidelines for office-based surgery. Unfortunately, the guidelines, which were issued in June 1999, are nonbinding, so there is no incentive for physicians to comply with them and no way for patients or state officials to know whether or not physicians are following them. The council stipulated that all physicians in New York receive a copy of the guidelines and that they be posted on a Web site. The committee recommended that the legislature empower the New York State Department of Health to issue regulations on office-based surgery, just as it already issues regulations for hospitals and ambulatory surgical centers. The regulations would have ensured that practitioners were credentialed in the fields in which they were doing procedures, established restrictions on administering anesthesia, and created minimum levels of equipment and maintenance schedules. State inspections of facilities would be conducted to ensure compliance. Had this legislation passed, it would likely have helped to improve the safety of office-based surgery in New York.
However, using the legislature as the means for creating regulations was not effective in New York. The lobbying of special-interest groups, especially the Medical Society of New York and the New York State Association of Nurse Anesthetists, and partisan interests of legislators killed support for the legislation. In 1999 a weaker measure, which calls for the reporting of complications and deaths from office-based procedures, was passed. New York State's health commissioner is responsible for compiling outcomes data based on reported events to determine whether errors occurred, so that the legislature can evaluate whether additional legislation is needed. Still, the end result of New York's effort fell short of its original goal and casts doubt on whether such attempts in other states can succeed.
In March 2000 the Florida legislature gave the Florida Department of Health Board of Medicine the authority to require physicians to report adverse incidents that occur in their offices. On 4 August 2000 the first adverse-incident reports were reviewed. Statistics provided by the state's Agency for Health Care Administration revealed that twenty adverse events, including five deaths (four of which were related to complications from plastic or cosmetic surgery), had been reported since March. All of these events required patients to be transferred to hospitals. This number was shocking to the board, but it is likely an underestimate, in part because adverse events that did not require hospitalization did not have to be reported. Three-fourths of the adverse events were related to surgical procedures, and 45 percent of the surgical procedures were related to plastic or cosmetic surgery.
Ban on Surgery. The Board of Medicine responded by placing a moratorium on Level III procedures. The board specifically cited concern with inadequate monitoring of patients who had received anesthesia and the bundling of too many different procedures into a single, long operation. The board hoped to discover why office-based settings had much higher incidences of adverse events than hospital and ambulatory surgery center settings had and to propose safeguards.
Physicians' Opposition. The board's decision was immediately controversial. The Florida Medical Association (FMA) filed a petition in a Florida District Court of Appeals seeking an emergency stay or immediate injunction to block the board's decision. The move was unsuccessful, as was an FMA proposal to modify the extent of the procedures covered by the ban. The FMA protested the sudden ban on procedures, arguing that the action eliminated many physicians' main source of income and infringed upon their professional autonomy. The FMA also argued that while some physicians may not be qualified to perform procedures in their office, the large majority are competent. Barring all physicians from performing procedures in their offices was characterized as harming patients, who were forced to move their procedures to a hospital or wait until after the ban was lifted.
Information Collection. During the ban the Board of Medicine and the FMA joined forces to create an ad hoc independent Outpatient Surgical Safety Commission, which collected information on surgeries performed in offices, ambulatory surgical settings, and hospitals and then reported its findings to the Department of Health. The study provided a preliminary understanding of the differences between office-based surgical procedures and procedures in hospitals and ambulatory surgery centers.
Two New Rules. On 7 November 2000 the moratorium expired, and the board allowed office-based Level III surgery to resume, with the addition of two emergency regulations. The first rule prohibits the combination of abdominoplasty with liposuction and liposuction with other surgical procedures. The second rule requires offices performing Level II and Level III procedures to implement risk management systems and submit all surgical logs to the Department of Health. The new rules also prohibit Level III procedures for patients with severe systemic diseases and require patients with certain conditions to obtain a complete physical before undergoing a procedure in an office setting.
In February 2001 Florida's Board of Medicine proposed that the temporary regulations be adopted permanently. The Board of Medicine continues to analyze reports of adverse events and surgical logs submitted by offices. Florida is continuing to develop comprehensive regulations to address the problems highlighted by the adverse-event reports. However, the state is doing so in a much more reactionary, piecemeal way than New Jersey is.
Health Affairs. 2002;21(4) © 2002 Project HOPE
Cite this: Preventing Errors In The Outpatient Setting: A Tale of Three States - Medscape - Jul 01, 2002.