Background

The medical care delivered in the emergency department (ED) is subject to a significant number of local, state, and federal regulations, as well as nongovernmental standards, that are designed to ensure quality care for each individual, ensure equity in care among all patients undergoing emergency evaluation, and protect vulnerable patients who may not be able to adequately advocate for themselves. Emergency physicians should be aware of the regulatory environment in which they practice because ignorance of these regulations (especially with respect to regulations of the Emergency Medical Treatment and Active Labor Act [EMTALA] and the Health Insurance Portability and Accountability Act [HIPAA]) may place both an individual physician and the institution at significant financial and legal risk.

Public Health Authority

Each state has the right to license and regulate both the health care facilities and providers within its jurisdiction. Generally, the state public health authority (state health department) administers this right. Even though all emergency physicians are, of course, aware that they, nurses, and other medical professionals obtain their medical licenses from the state department of public health, relatively few know of the extent to which their hospitals and associated departments (e.g., hospital EDs, operating rooms, computed tomography scanners, cardiac catheterization laboratories) must obtain similar permissions to deliver health care or the extent to which hospitals may be subject to review in the event of a perceived or reported problem. In addition to state regulation, hospitals are also generally subject to “Conditions for Coverage (CFC)” and “Conditions of Participation (CoP)” from the Center for Medicare and Medicaid Services (CMS) of the federal government. According to the CMS, the CFC and CoP are the “minimum health and safety requirements that hospitals must meet to participate in the Medicare and Medicaid program.” Although the CFC and CoP are not generally required of hospitals for licensure, hospitals are mandated by federal law to meet the standards if they wish to receive Medicare and Medicaid reimbursement for their services. Because Medicare and Medicaid funding is a substantial part of most hospitals’ revenue, most hospitals adhere to the CMS CFC and CoP regulations, as well as those of the state health department.

Because the responsibility to regulate and monitor health care institutions is so great, most states and the CMS share, delegate, or “deem” some portions of this regulatory authority to national expert organizations to help them oversee the quality of health care delivered in their state.¹ The most visible of these expert organizations is the Joint Commission, formerly known as the Joint Commission on Accreditation of Healthcare Organizations (JCAHO). Other organizations to which states frequently delegate regulatory authority include the American College of Surgeons, which sets standards for trauma centers, and the American Burn Association, which sets standards for burn centers. In addition to delegating portions of their authority to national organizations, state departments of public health may also delegate portions of their authority over health care institutions to local public health officials. One example is the receipt of reports of suspected or confirmed cases of reportable communicable disease.

In no case does any sharing of authority supersede the state’s ability to regulate and oversee health care quality. Indeed, although some states and the CMS recognize Joint Commission accreditation as evidence of meeting acceptable standards, both states and the CMS can always perform their own inspections of facilities, in addition to the Joint Commission surveys. Furthermore, whenever there is a question or concern regarding specific care delivered, the state public health authority generally carries out the site inspection and investigation on its own.

The Joint Commission

The Joint Commission is a private, not-for-profit organization. Its mission is to “continually improve the safety and quality of care provided to the public through the provision of health care accreditation and related services that support performance improvement in health care organizations.”² Broadly, the Joint Commission sets standards that hospitals must meet to receive accreditation (and generally, by extension, licensure from the state) and receive funding from the CMS. These standards cover a broad range of subjects from patient rights, to patient care, to infection control. The Joint Commission also integrates outcomes and other performance measures into its standards. To maintain their accreditation, health care organizations must undergo a site survey by Joint Commission staff every 3 years. Laboratories must undergo a site survey every 2 years for the same accreditation.

Over the years the Joint Commission has created a number of special programs and work groups with particular relevance to the ED, including groups specifically examining ED overcrowding and hospital emergency preparedness. The most overarching of the Joint Commission programs related to the ED is the set of National Patient Safety Goals (Table 211.1). These goals have been revised and expanded over the years to appropriately reflect the changes in clinical care that have evolved, as well as to address systemic sources of error in medications as they are identified.

Table 211.1 2011 Joint Commission National Patient Safety Goals

Although many departments and practitioners frequently see the Joint Commission requirements as a burden, especially at the time of their site visit, it is important to remember that the purpose of the requirements is to enhance patient safety and reduce opportunities for error. By developing programs that satisfy the Joint Commission requirements, EDs and individual physicians will decrease their risk for adverse events and better mange their medical liability.