One might hope that professionalism and concern for patients would be sufficient incentive to motivate safe behaviors on the part of providers, as well as institutional investments in system safety. Sadly, experience has taught us that this is not the case. There are simply too many competing pressures for attention and resources, and the nature of safety is that individuals and organizations can often get away with bad behavior for long periods of time. Moreover, it is unlikely that all providers and institutions will or can keep up with best practices, given a rapidly evolving research base and the never-ending need to keep at least one eye on the bottom line.

These realities create a need for more prescriptive solutions to safety: standards set by external organizations, such as accreditors, regulatory bodies, payer representatives, and government. This chapter will examine some of these solutions, beginning with regulations and accreditation.

Regulation is “an authoritative rule,” while accreditation is a process by which an authoritative body formally recognizes that an organization or a person is competent to carry out specific tasks. Much of what we tend to call regulation is actually accreditation, but takes place in an environment in which a lack of accreditation has nearly the impact of failing to adhere to a regulatory mandate. For example, the Accreditation Council for Graduate Medical Education (ACGME), the body that blesses U.S. residency and fellowship programs, is not a regulator but an accreditor. Nevertheless, when the ACGME mandated that residents work less than 80 hours per week in 2003 and proscribed traditional overnight call shifts for first-year residents in 2011 (Chapter 16), these directives had the force of regulation, because ACGME has the power to shut down training programs for noncompliance.1

The most important accreditor in the patient safety field (in the United States) is the Joint Commission (formerly the Joint Commission on Accreditation of Healthcare Organizations [JCAHO]). The Joint Commission, which began in 1951 as a joint program of the American College of Surgeons (which launched the first hospital inspections in 1918), the American College of Physicians, the American Hospital Association, the American Medical Association, and the Canadian Medical Association, has become an increasingly powerful force over the last decade by more aggressively exercising its mandate to improve the safety of American hospitals (and now, through its Joint Commission International subsidiary, hospitals around the world). A list of Joint Commission National Patient Safety Goals, one of the organization’s key mechanisms for endorsing practices, highlighting safety problems, and generating action, is shown in Appendix IV.

Until the mid-2000s, Joint Commission visits to hospitals were announced years in advance and focused on hospitals’ adherence to various policies and procedures. In 2006, the process became far more robust: the accreditor’s visits now come unannounced (in my own hospital, it is now a staff member’s job to check the Joint Commission’s Web site at 7 am every Monday to see if there will be inspectors in our lobby a half-hour later), and much of the visit centers around the “Tracer Methodology,” a process by which the inspectors follow a given patient’s course throughout the hospital, checking documentation of care and speaking to caregivers about their actions and their understanding of safety principles and regulations. In my judgment, this more vigorous approach to safety enforcement has been an important force for improving safety.2,3

Beginning soon after Medicare was founded in 1965, the Joint Commission was granted an exclusive arrangement by the Centers for Medicare & Medicaid Services (CMS) to act as its inspection arm. Known as a deeming authority, CMS made the presumption that a hospital that passed a Joint Commission inspection was also in compliance with the CMS Conditions of Participation. In essence, this is what gives a Joint Commission inspection its teeth: failure puts an organization at risk of losing its Medicare payments, a significant portion of most U.S. hospitals’ revenue. After a few high profile cases in which Joint Commission-accredited hospitals were later revealed to have major safety problems, in 2008 CMS announced that it would extend deeming authority to other organizations that met its requirements.4 As of this writing (late 2011), only one other entity (DNV Healthcare) has been granted such authority; it now accredits a few hundred U.S. hospitals (vs. several thousand for the Joint Commission).5

Although the Joint Commission does regulate some physicians’ offices and ambulatory sites (such as surgery centers), most such sites are either unaccredited or accredited by another organization, such as the American Association for the Accreditation of Ambulatory Surgical Facilities (AAAASF).6 In recent years, concerns have been raised about the safety of ambulatory surgery, in particular, and an increasingly forceful set of accreditation standards has been implemented in these environments. Despite this change, the ambulatory environment continues to be affected far less by the pressures of regulation and accreditation, one of the key differences between patient safety in inpatient and office settings (Chapter 12).

Physicians are subject to both regulation and accreditation standards as well. In the United States, physicians require a license to practice; such licenses are issued by the individual states, and are not specialty specific. While physicians can lose their licenses for problems that include substance abuse, criminal convictions, and incompetence, they rarely do (Chapter 19). The process of license renewal has traditionally been relatively benign, often involving proving attendance at a certain number of continuing education conferences rather than showing evidence of ongoing competence. The Federation of State Medical Boards has announced its intention to implement Maintenance of Licensure (MOL) requirements, in which physicians will need to demonstrate ongoing competency and commitment to professional development. The specifics of this program are still being worked out, and it is likely that specialty board Maintenance of Certification (MOC) activities (see below) will be accepted as meeting MOL requirements.7

A higher bar for physicians is board certification, a voluntary process through which doctors participate in activities designed to show that they are currently competent in their own specialty (truth in advertising: I have long served on the largest specialty board, the American Board of Internal Medicine). While board certification differs from licensure in many ways, a key difference is that board certification is specialty specific: one is board certified, for example, as an internist or a pediatric cardiologist, whereas licensure has traditionally been specialty agnostic. To become board certified, physicians complete training programs (either residencies, for initial training in areas such as internal medicine, surgery, or pediatrics, or fellowships, for specialized fields such as endocrinology or interventional radiology). They then “sit for the boards” to obtain their initial board certification. Approximately 750,000 U.S. physicians are board certified in at least one of 147 specialties and subspecialties. There is good evidence that board certification is associated with higher quality of care.8–11

Until the late 1980s, initial board certification lasted for an entire career for the vast majority of medical specialists. However, given healthcare’s breakneck pace of change, the fact that other professionals (e.g., pilots and teachers) have to recertify every few years, and the evidence that older physicians may, in fact, deliver lower quality care,12 the American Board of Medical Specialties (the umbrella organization for all 24 specialty boards) now requires that its diplomates participate in MOC programs.13 The requirements for MOC include not only passing a specialty-specific test (Part III) but also engaging in activities to measure the quality of care in one’s own practice, and demonstrating a commitment to improving quality and safety (Table 20-1). As of 2011, more than 300,000 U.S. physicians were participating in at least one MOC program, although a similar number finished their training prior to recertification requirements (“grandfathers”). The size of this latter group, of course, will rapidly fall over the next several years, and by 2020, the vast majority of board certified physicians will be enrolled in MOC, an important development in efforts to promote patient safety.

While there are many other ways of measuring physician competence,14 and a variety of other stakeholders (such as insurance companies and consumer-oriented Web sites) are trying to do so, the boards have some unique attributes. First, board certification is a voluntary process organized by the medical profession itself, giving it higher credibility among physicians than measures created by outside organizations. Second, because of the challenges in measuring diagnostic acumen (Chapter 6), the boards have a singular role in assessing physicians’ knowledge and diagnostic abilities. Patients generally put a significant amount of stock in knowing that their doctor is board certified, rating it among their most highly valued measures of quality.8 Increasingly, insurers and hospitals are requiring that their physicians be board certified and actively participate in MOC, although many gaps remain.15

Regulation is more potent than accreditation, in that compliance is mandatory (no hospital has to be accredited by the Joint Commission and no doctor has to be board certified, though the vast majority of both hospitals and physicians choose to be) and failure to comply generally carries stiff penalties. Today, the main U.S. regulatory authorities relevant to patient safety are state governments, although there are a few federal regulations and a handful of counties and cities have safety-related regulations. Unlike countries with national health systems (such as the UK’s National Health Service16), in the United States there is no single entity with the authority and mandate to regulate patient safety, which explains why this function has largely been left to states. (Medicare is increasingly assuming this role, a point I’ll return to a little later.)