Key points

Background

Patient safety in ambulatory surgery settings has evolved through a combination of state/federal regulation, private accreditation, and increased patient awareness.

A function of state government is the protection of the public. The control of the practice of medicine is a primary exercise of this function. This control is exhibited both in the licensing of those who may practice medicine and in the settings in which it can be practiced. Legal precedent for the privatization of public protection functions exists in a variety of decisions by both state and federal courts.

Technological advances have allowed health care services to migrate across settings increasingly outside of the hospital, and regulatory jurisdictions have the unenviable obligation to protect a public receiving care in more numerous and diverse facilities. From the regulatory perspective, ambulatory surgery encompasses outpatient health care facilities ranging from large multi-suite ambulatory surgery centers to single-physician procedure rooms. Although cosmetic and plastic surgery receive a disproportionate amount of media and legislator attention, concerns related to outpatient care and oversight are not unique to any specialty. Government agencies have the ultimate responsibility to ensure the safety of their constituents and have increasingly turned to private accrediting bodies to establish a comprehensive regulatory program partnering state enforcement authority and private survey capabilities. Twenty-seven states now accept or mandate accreditation in at least one of the ambulatory settings.

Private accreditation evolution

Historically, “Professional societies began regulating medical practice by examining and licensing practitioners as early as 1760. By the early 1800s, the medical societies were in charge of establishing regulations, standards of practice, and certification of doctors.” As medical education and regulation began to mature, care began to migrate from the home to the hospital. Emanuel Codman, MD, first proposed for the standardization of hospitals in 1910. The first set of requirements was developed by the American College of Surgeons in 1917: a 1-page document. Accreditation mandates in ambulatory surgery are legacies inherited from hospital oversight. The manner in which regulatory oversight is delegated by government to third-party agencies approximates hospital oversight regimen that began with the Hospital Standardization Program in the early part of the twentieth century and formalized with mandated Joint Commission accreditation for Medicare-participating hospitals in 1965. Delegation of authority has followed the decentralization of health care services because it is quite effective for government to identify private regulatory partners whereby public agencies may have a particular weakness or limitation. “The American College of Physicians, the American Hospital Association, the American Medical Association and the Canadian Medical Association joined with the American College of Surgeons as corporate members to create the joint commission on accreditation of Hospitals in 1951.” In 1965 The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) was recognized in the Social Security Amendments to provide accreditation of hospitals.

Federal regulatory efforts lagged behind the changes in the provisions of health care. In the early 1970s there was a significant migration of health care and surgical services from the hospital to neighborhood regional ambulatory centers. JCAH at the time did not provide a program of accreditation for these centers. To meet this need, the Accreditation for Ambulatory Health Care was incorporated in Illinois.

In 1980 the American Society of Plastic and Reconstructive Surgeons recognized that surgeons operating in freestanding facilities were unable to access accreditation through JCAH or Accreditation for Ambulatory Health Care and established the American Association for Ambulatory Plastic Surgery Facilities to design and operate a single-specialty accreditation program for outpatient plastic surgery centers. Based on inquiries by other surgical specialties, the American Association for Ambulatory Plastic Surgery Facilities formed the American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF) in 1992 to accredit other single-specialty and multispecialty surgery facilities, owned and operated by physicians certified by the American Board of Medical Specialties. AAAASF currently accredits facilities that include all the American Board of Medical Specialties surgical disciplines.

This evolution is consistent with other business sectors requiring specialized knowledge, because agencies often rely on regulation by private arm’s length organizations with expertise in the subject matter. Health care facilities, prisons, and institutions of higher learning are commonly associated with private accreditation, not surprising given that the concepts related to administering such institutions are likely to be foreign to most people outside of those fields. Accreditation organizations are representative of the industries they regulate; thus, the people setting and revising standards work in the field and are at the forefront of research, driving the latest developments in quality and safety.

Deferring to private accreditation is, at least in part, an acknowledgment of the institutional inertia that can delay regulatory changes. Although it is certainly possible for a public agency to create its own set of standards, it is less probable for that agency to keep up with the rapid developments of the industry. Revision attempts slow considerably due to political negotiations, bureaucratic review processes, and public comment periods. Competing interests each have the opportunity to voice their opinions during the public revision process, sometimes yielding few rewards. The original Medicare hospital conditions for participation were published in 1966; attempted updates to the conditions began in 1977 but were not finalized until 1986. The Centers for Medicare and Medicaid Services published its first major revisions to the ambulatory surgery center conditions for coverage in mid-2008, 26 years after the initial adoption. By contrast, accreditation organizations typically revisit their standards annually to at least study minor adjustments, if not to undertake wholesale revisions.

Federal and state agencies’ biggest impetus for delegating to accreditation agencies may be cost. Administering an inspection and certification regime is a costly enterprise in financial and personnel terms. Private organizations can often realize cost efficiencies that are impossible for government agencies and can therefore perform inspections with lower operating costs. Many states have statutory limits or prohibitions on fees that a facility may be charged. Higher costs and budgetary limits exert extraordinary pressure on government programs. In 1991 Medicare estimated that internally administering the hospital certification program would require 722 additional full-time personnel, an increase of nearly one-third, and $59 million in operating costs that would have to be absorbed into the budget. The state of Washington administers a portion of its Ambulatory Surgery Facility licensing and inspection program, performing at least 1 of the 2 surveys that each facility must complete in each 36-month period. The state department of health identified that its initial cost and personnel estimates for operating the licensing program were shorter than the actual needs and was able to secure statutory authority to raise licensing fees and add staff. The result is a new tiered licensing fee structure with a maximum 3-year fee of $10,068, or $5410 if the facility is accredited. Private accreditation agencies charge fees directly to facilities; thus, they are not in such a precarious financial position and are able to adjust staff accordingly.

Simple efficiency certainly plays a role in government’s willingness to accept or mandate accreditation in lieu of a state process. In the mid-1990s the 2 major US plastic surgery societies (American Society for Aesthetic Plastic Surgery and the American Society of Plastic Surgeons and The American Society of Plastic and Reconstructive Surgeons) mandated that all members operate only in licensed or accredited facilities. This mandate was a critical turning point for plastic surgery as well as for accreditation. The mandate was a demonstration to medical boards and public advocates of the specialty’s commitment to quality and safety. Continuing to operate in the office, terrifyingly called unlicensed facilities, as many plastic surgeons did, only put their reputations and professional licenses at risk. As more jurisdictions considered regulating all outpatient settings, the existing foundation of specialty mandated accreditation must have presented an attractive option for regulatory oversight without adding a redundant inspection process.