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.

Two specific programs that institutions are required to use to help them achieve the national patient safety goals are the “do-not-use list” and the “universal protocol.” The universal protocol was developed by The Joint Commission to prevent “wrong site, wrong person, wrong procedure” surgery and is required of accredited institutions. Although the universal protocol has clear safety benefits for some of the patients cared for in the ED, many emergency physicians remain uncertain of which specific procedures require use of the universal protocol. Even though it is difficult to conceive that repair of a laceration or emergency intubation could be performed on the wrong limb or wrong patient, it is possible that tube thoracostomy, lumbar puncture, or central venous cannulation (among other procedures) could be performed in the ED on the wrong patient, especially when a patient’s visit spans different shifts or when consultation services are requested to perform procedures. Thus, for the appropriate circumstances and procedures, EDs must develop and use a universal protocol that includes provisions for a hard-stop “timeout” in which the physician and nursing staff stop to ensure that informed consent has been given, that the procedure is warranted, and that it is performed on the correct patient at the correct site before selected procedures are performed.

The do-not-use list is a compilation of medical abbreviations that have been identified as the most likely sources of error found when orders are either miswritten or misinterpreted (or both) (Table 211.2). The growing use of computerized order entry systems and computerized prescription writing programs is likely to decrease the number of these types of errors; however, physicians who write handwritten orders must be familiar with the prohibited abbreviations, and departments should bar them from use in clinical practice.

Table 211.2 2010 Joint Commission Do-Not-Use List

^* Applies to all orders and all medication-related documentation that is handwritten (including free-text computer entry) or on preprinted forms.

^† Exception: A “trailing zero” may be used only when required to demonstrate the level of precision of the value being reported, such as for laboratory results, imaging studies that report size of lesions, or catheter or tube sizes. It may not be used in medication orders or other medication-related documentation.

^‡ For possible future inclusion in the official do-not-use list.

Emergency Medical Treatment and Active Labor Act

One of the most confusing, misinterpreted, and misquoted set of regulations in emergency medicine is EMTALA. Even the name itself can be confusing because the regulations are sometimes inexactly referred to as “COBRA,” which refers to the broader Consolidated Omnibus Reconciliation Act in which the original EMTALA statutes were enacted. First enacted in 1986 and significantly revised in 2003, EMTALA originated as a response to several well-publicized allegations of patient “dumping” in which patients were alleged to have been turned away or transferred from EDs without appropriate care. Broadly, EMTALA creates two major requirements for hospitals that have a dedicated ED and participate in CMS programs. First, patients who “come to” the emergency department and request care must receive an appropriate medical screening examination. Second, for patients with an identified “emergency medical condition,” the emergency physician must either provide appropriate stabilization or arrange transfer to another facility and meet several additional specific requirements pertaining to the transfer.³ Although EMTALA applies to hospitals that receive CMS funding, it applies to all patients, not simply those with Medicare or Medicaid insurance.

The first requirement under EMTALA, the “medical screening examination,” must be provided to all individuals who go to the ED requesting an evaluation for a medical condition. Although the specific components of this examination remain ill defined, it is generally agreed that an examination should be performed so that the clinician can say with “reasonable clinical confidence” that an emergency condition is not present that may place an individual’s health (or the health of an unborn child) in serious jeopardy, seriously impair body functions, or represent serious dysfunction of body organs. Furthermore, this medical screening examination must be provided without regard to the ability to pay, insurance status, race, citizenship, or gender.

The second requirement under EMTALA is to provide appropriate stabilization for an emergency medical condition, once identified. In general, this means that an appropriate level of medical care must be provided in the ED or in the hospital (or in both) for the acute medical problem of the patient, again without regard to the ability to pay, insurance status, race, citizenship, or gender. This provision of EMTALA also has implications for on-call physicians. As part of Medicare, hospitals must maintain on-call physicians who are able to provide the medical services needed to treat an emergency medical condition after the medical screening examination. Although the list of on-call physicians is not required by Medicare to be comprehensive, the specialties represented in the on-call list must be appropriate to best meet the needs of its patients within the hospital’s capability. If a hospital does not maintain an appropriate on-call roster or if an on-call physician does not show up to care for a patient with an unidentified emergency medical condition within a reasonable amount of time, that hospital and the on-call physician may be liable under EMTALA statutes.

In the event that the ED or the hospital (or both) are unable to provide appropriate stabilization, EMTALA allows transfer of patients from one facility to another under certain, very specific conditions. First, the patient must request the transfer and a physician must state in writing that the medical benefits of the transfer outweigh its risks. Second, the hospital that receives the transferred patient must be “appropriate” and have both the space and qualified personnel to treat the emergency medical condition (Box 211.1).⁴

Penalties for violations of EMTALA statutes can be significant for both the physician and the institution. Both the physician and the hospital can be liable for fines of up to $50,000 per violation, and both can be excluded from future participation in CMS programs. Generally, malpractice insurance specifically excludes EMTALA violations. Furthermore, hospitals that receive patients transferred in violation of EMTALA statutes may bring a civil suit against the transferring institution to recover the financial loss created by the inappropriate transfer.

Health Insurance Portability and Accountability Act

HIPAA was initially enacted in 1996 in an attempt to make it easier for individuals to transfer their medical records and health care coverage and also to provide greater accountability among providers to limit fraud.⁵ Subsequent federal rules defining privacy standards under HIPAA have substantially changed the way in which health care providers and health plans collect, store, and share health information.

Health care providers, institutions, health plans, and health care clearinghouses are all required to conform to HIPAA standards (Box 211.2). Accordingly, they are all known as “covered entities.” Broadly, HIPAA standards require that all covered entities have appropriate policies and procedures in place to ensure the privacy of all personally identifiable health information that they store and also that personally identifiable health information be shared only with the patient’s permission and only in appropriate circumstances.⁶ Being covered entities under HIPAA means that health care providers, institutions, and health plans may share health information with one another, when appropriate, without needing to verify the privacy protection of one another. Each covered entity is assumed to have appropriate electronic and physical access controls to patients’ medical records and electronic data and to conduct routine audits of its data security procedures.

From the perspective of the emergency physician, HIPAA means that personal health information should be obtained or accessed only when it is relevant to immediate care of the patient. Furthermore, personal health information should be disclosed only to other covered entities and only with the patient’s permission. Sanctions for violating HIPAA standards include civil and criminal penalties with fines of up to $250,000 or imprisonment for up to 10 years (or both) for knowingly misusing a patient’s identifiable health information.⁷

Special Circumstances