Chapter 303: Legal Issues in Emergency Medicine

Informed consent is the legal standard under which providers educate patients (those who have the capacity to make medical decisions or their surrogates) about proposed treatments and alternatives.¹ The desirability of informed consent is based on the belief that it fosters the twin concepts of patient well-being and autonomy. Informed consent also provides a legal basis for autonomy.

Providers should act in their patients' best interests while preserving autonomy whenever possible. The American College of Emergency Physicians Code of Ethics² recognizes this dual obligation in stating that emergency physicians "serve the best interest of their patients by treating or preventing disease or injury and by informing patients about their condition." The code of ethics goes on to say, "Adult patients with decision-making capacity have a right to accept or refuse recommended health care, and physicians have a concomitant duty to respect their choices. This right is grounded in the moral principle of respect for patient autonomy and is expressed in the legal doctrine of informed consent."²

BASIC ELEMENTS OF INFORMED CONSENT

Most patients arriving at the ED sign a general consent for treatment. General consent for treatment is widely understood to cover history taking, standard examinations, and basic procedures such as venipuncture and blood analysis. General consent forms do not provide consent for more detailed, risky, or invasive procedures.

Informed consent requires two conditions: the patient possesses decision-making capacity, and the patient can make a voluntary choice free of undue influence. The process of informed consent begins with the delivery of information to the patient by the provider. The patient must then reach a decision and authorize the procedure or treatment. Each part of the process is considered individually.

Patient Capacity

Decision-making capacity (hereafter called "capacity") is the ability of the patient to make informed medical decisions. It is the provider's task to determine the patient's capacity.³ The definition of capacity varies among jurisdictions, but, in general, capacity describes an individual's ability to make a decision based on personal values and comprehension of the likely consequences of that decision.^4,5

One definition of capacity as it relates to health care is from Illinois law and reads: " 'Decisional capacity' means the ability to understand and appreciate the nature and consequences of a decision regarding medical treatment or forgoing life-sustaining treatment and the ability to reach and communicate an informed decision in the matter as determined by the attending physician."⁶ The American College of Physicians Ethics Manual describes decision-making capacity as "the ability to receive and express information and to make a choice consonant with that information and one's values."⁴

Competence, which is often incorrectly used interchangeably with capacity, is a legal term indicating a ruling by a court that a person is able to manage his or her own affairs.⁷

The capacity to make a medical decision is based on several basic abilities: the ability to receive information; to process and understand information; to deliberate about a decision; and to make, articulate, and defend choices. Generally, the physician assesses the above-listed patient abilities informally, by taking a history from an alert patient with no barriers to communication. Any barriers to communication as a result of language should be removed through translation, when possible, by an impartial medical translator.

Patients with altered mental status may not possess the memory or attention to receive and process the information and thus lack capacity.^8,9 However, diagnoses often associated with altered mental status, such as stroke, psychiatric illness, or dementia, should not lead to a presumption of incapacity. Assess whether or not the disorder affects patients' cognitive abilities.⁵ Disagreement with the physician's plan does not indicate a lack of capacity if the decision was made in a rational way, which the patient can defend based on their values and beliefs.⁹ A patient's decision-making capacity may change over time in the ED based on changes in medical condition, for example, in patients recovering from intoxication, hypoglycemia, or hypoxia.

Capacity may depend on the complexity of the decision and consequences of accepting or rejecting the intervention. For example, a patient may be competent to make a minor decision but not a major decision at a given point in time.¹⁰ The more important the decision, the more important is the assessment.^4,11

Factors useful to assess capacity are summarized in Tables 303-1¹ and 303-2.¹¹

If a patient has capacity to make a given decision, his or her wishes should be respected.

Free Choice

Informed consent must be voluntary and free of coercion. The choice must be free of manipulation or threats by providers, family, or other outside influences, and free of emotional or physical coercion.²

Information Necessary for Patient Decision Making

The physician must provide the patient with the information needed to make a reasoned, informed decision. Generally, the provider performing the procedure should be the one to obtain consent. A delegate such as a resident or nurse practitioner may obtain consent, but the supervisor is responsible to ensure that consent was truly informed.¹² The required information for decision making is the diagnosis; the nature and purpose of treatment; risks and consequences of treatment; alternatives and their risks and benefits; and prognosis if treatment is or is not accepted.¹²

How much information is necessary to meet the above requirement depends on the standard of disclosure being applied. There are two standards, each used in a large number of states, that address the details of the disclosure for consent.¹² The "reasonable person standard" for informed consent requires providers to give the patient all the information a "reasonable person" would need to make the same decision under similar circumstances.¹³ The alternate standard is the less stringent "professional standard" for informed consent, which requires disclosure to be the same as any reasonably prudent, similarly trained physician would provide in a similar circumstance.¹² Emergency providers are well served to give more, not less, information to the patient.

Discussion and Decision

Give the patient the opportunity to ask questions while considering the decision. The patient can be made realistically aware of ED time constraints for decision making, but without using coercion. Patients willing to continue should then give explicit authorization for the treatment or procedure. If the patient agrees too easily, has no questions, or is not engaged in the process, review the situation for barriers to communication such as language issues. A patient who is unable or unwilling to express a preference for a particular course of action may be presumed to lack capacity.¹⁴

DOCUMENTATION OF CONSENT

When obtaining informed consent, it is the process that is most important. Some states have specific requirements regarding written consent.¹² Where specific requirements regarding written consent are not present, oral consent is generally as good as written consent except that written documentation signed by the patient can aid the provider should the consent process be challenged later on.¹² At a minimum, the chart or consent form (material forms are required by Medicare for all nonemergency surgical procedures) should reflect who obtained consent; the provider(s) authorized to perform the treatment; that information on risks, benefits, and alternatives were disclosed; and that the patient had the opportunity to ask questions.^12,13,15 Ideally, the chart will contain both a signed consent form and a well-documented recap of the consent process.¹⁶

EXCEPTIONS TO INFORMED CONSENT

There are a number of exceptions to the right to informed consent in response to specific healthcare situations. These exceptions include emergencies; therapeutic privilege; public health imperatives, such as the treatment of certain diseases; patient waiver of consent; and, rarely, emergency research.^12,17 Of these, only emergencies and public health imperatives are applicable to clinicians working in the ED on a day-to-day basis.

Emergencies

Emergency providers should render needed emergency treatment even in situations where consent cannot be obtained or ascertained in a timely fashion due to the nature of the illness. Implied consent, the basis of this exception, is that a reasonable person would give consent to emergency or lifesaving treatment.^12,18 If treatment can be delayed without harm, obtain consent before treatment. Should the situation change during treatment, obtain consent before further treatment.

Public Health Imperatives

Public health imperatives are situations where the public good may limit individual patient autonomy. Patients with high-risk communicable diseases,¹⁹ such as severe acute respiratory syndrome and tuberculosis, and patients with mental illness who pose a danger to themselves or the public are examples. Each state has regulations regarding communicable diseases and mental health law, and providers should be familiar with rules in their practice location. When patients meet criteria for health department–mandated treatment and quarantine, yet do not give consent, consult hospital infectious disease staff and local health officials as soon as possible.

WHEN INFORMED CONSENT CANNOT BE OBTAINED

If a patient does not have the capacity to give informed consent for a condition where no exception exists or once an emergency has been stabilized and nonemergent decisions need to be made, providers should identify a surrogate decision maker or directive.^2,9 First, inquire about advance directives or healthcare powers of attorney that can provide guidance or specify a decision maker (see chapter 300, "Death Notification and Advanced Directives"). In the absence of a power of attorney, state law may determine the patient's decision maker. A typical decision-making progression would be: spouse, adult children, parents, adult siblings, and the nearest relative not previously described.²⁰ Surrogates are expected to help providers determine what the patient would want in a particular situation and should not substitute their values for the patient's. Should no person be available for treatment decisions, providers should proceed with the patient's best interest in mind and involve hospital counsel to begin a guardianship process if the patient's lack of capacity is likely to be of significant duration.¹⁰

INFORMED REFUSAL

Patients may refuse part of a treatment plan, refuse to be evaluated entirely, or wish to leave before the completion of the planned evaluation. In these situations, the physician should ensure there are no miscommunications or misunderstandings at the root of the refusal.¹⁰ Often, when issues are clarified, an agreement can be reached. Second, correct issues that may prevent an open, noncontentious discussion—such issues may be a blanket, a call to the patient's personal physician, or additional pain medication.^10,21 Finally, try to develop an alternative to the original plan that does not significantly alter the risk to the patient. For instance, a patient may not want a certain procedure but would be willing to accept admission for further evaluation.¹⁰

When communication and negotiation between the patient and provider fail and the patient possesses decisional capacity, the patient may choose to refuse care or end the encounter "against medical advice."

Approximately 1.4 million patients left hospital EDs against medical advice in 2010, representing 1% of patients.²² Studies have documented poor outcomes in patients leaving against medical advice.^23,24 Characteristics of patients who leave against medical advice include lack of insurance, male, younger age, alcohol or drug dependency, psychiatric illness, and low income.^23,24 Patients often have serious complaints such as chest pain, abdominal pain, or trauma. Patients give many reasons for their desire to leave, including outside obligations such as family or pets, the wish for treatment at another hospital, concerns for cost of treatment, fear of recommended treatment, a desire for tobacco, drugs, or alcohol, narcotic requests, or improvement in the condition that prompted the ED visit.²⁵

To proceed with an against-medical-advice discharge, assess the patient's capacity, with special attention to barriers limiting capacity. Alcohol use and psychiatric diagnoses are not absolute barriers to discharge against medical advice, with the exception of suicidal and homicidal patients. Document the patient's behavior that clearly demonstrates there was no impairment of capacity by intoxication or mental illness. Educate the patient about the risks associated with refusing to complete evaluation and/or treatment. Discuss the patient's reasons for leaving, because these often present opportunities for negotiation and convincing the patient to continue care.⁹ Use plain language and avoid medical terms. Given the medical-legal and patient risks of against-medical-advice discharge, make a substantial effort to convince the patient to remain but do not resort to threats. Incorrect statements such as "insurance will not pay for this visit if you leave against medical advice" may further damage the patient–provider relationship and discourage the patient from returning.^26,27 Model documentation of an against-medical-advice discharge should contain the following elements^21,28:

• Documentation of capacity (ideally with examples and examination clearly noted)

• Discussion of the risks reviewed with the patient including what diagnoses were being considered

• Explicit documentation in the chart that the patient was leaving against medical advice and what treatments, procedures, and courses of actions were refused by the patient

• Offers made of alternative treatments or courses of action

• Efforts to involve family, friends, or clergy in the decision

• Explanation of any potentially problematic entries in the chart such as nursing notes or abnormal laboratory values—for example, if the patient has an elevated serum alcohol level, document that the patient is clinically sober and has capacity, if true

• Patient's signature on the against-medical-advice form, and if patient refuses to sign, document that fact

• Documentation of treatment and follow-up provided

• Documentation that the patient was told he or she is welcome to return at any time

While the most important part of documenting an against-medical-advice discharge is the discussion with the patient addressing the items above, having the patient sign an actual against-medical-advice form may help provide further liability protection in three ways: "1) it may terminate the providers legal duty to treat a patient; 2) creation of the affirmative defense of 'assumption of risk'; and 3) the creation of a record of evidence of the patient's refusal of care."²⁹

When a patient leaves against medical advice, reasonable treatment should be provided as appropriate for the patient's medical condition and concordant with the patient's wishes. For example, provide antibiotics for infection, aspirin for chest pain, or stabilization for fractures. Tell the patient to return at any time. Provide a listing of resources for close follow-up and instruct the patient on signs and symptoms to prompt a return visit to the ED should the patient change his or her mind.^9,21

It is also important to document situations when a patient leaves against advice or before treatment is completed without informing ED staff. Out of sight should not equal out of mind. Attempt to locate the patient within the facility and then check logical destinations. Often a phone call to the patient's home, cell phone, or emergency contact can provide an opportunity to encourage the patient to return to the ED. Document such communication attempts and their outcome.

The concepts of patient capacity and informed consent and refusal, their exceptions, and the moral obligations that underlie them should be integrated into daily ED practice.

A minor is generally considered to be anyone less than 18 years of age, and parental consent is generally required for the treatment of minors. However, society and the legal system have determined that, in some circumstances, older children may be able to make many medical decisions independent of their parents.³⁰ Exceptions to parental consent for minors include emergencies, the treatment of certain diseases and conditions that are in the best interest of the minor or society, minors emancipated under law, and circumstances in which the best interests of the child are not being addressed by parents. State laws regarding minor care vary widely; providers caring for minors should review state regulations and call on legal counsel as needed.

TREATMENT OF MINORS IN EMERGENCIES

Minors often present to the ED without a parent or legal guardian in the care of an alternate caretaker such as a grandparent, school teacher, babysitter, camp counselor, or social worker.

In the United States under the Emergency Medical Treatment and Active Labor Act (EMTALA), EDs are legally obligated to evaluate all patients presenting with a medical condition and stabilize any emergency condition identified. There is no requirement for consent in this situation.^31,32 Providers have latitude in defining an emergency medical condition (EMC), especially if there is a delay in obtaining consent. It is always best to try to find parents or legal guardians while emergency care is being provided. Document all such efforts. Once the emergency condition is stabilized, the need for appropriate parental informed consent applies.

When an adult family member, such as a grandparent or adult sibling, brings the minor to the ED and has granted consent, care should be given while efforts are made to contact the parent or guardian. In the case of preplanned parental absence, not all U.S. states require a signed note from the parent authorizing treatment. In some U.S. states, laws authorize relatives to consent to medical treatment for minors under their care. However, if the treatment proposed carries a substantial risk and is not emergent, contact the parents or guardian before proceeding. Providers may obtain parental consent by telephone. In cases where no appropriate party can be reached to give consent, particularly in the case of invasive procedures, it is recommended that, when possible, the provider document a second opinion agreeing with the need to perform the procedure on an emergent basis.

EMANCIPATED MINORS

Minors who have become independent from the care and control of their parent or guardian are considered emancipated and may provide consent as adults. The definition of emancipation varies, and some states do not have specific emancipation statutes.³³ Common situations in which minors may be considered emancipated include minors who are married, enlisted in the U.S. armed services, pregnant or parents themselves, declared emancipated by a court, or self-supporting and not living at home.

Mature Minor Exception

The mature minor exception states that if a minor is sufficiently mature to understand the nature and consequences of a proposed medical treatment, then the minor should be able to consent or refuse treatment without parental involvement. The mature minor exception is accepted under common law and, in some states, under specific legislation. Requirements for the mature minor exception are as follows: the child should generally be at least 14 or 15 years old; the treatment should be beneficial, not elective, and of low risk; and the minor must meet the requirements of informed consent. Given the subjectiveness of this standard, it is prudent to carefully consider each individual case before treating a minor under the mature minor doctrine.³⁴

If a minor is considered capable of providing informed consent for a given issue, then he or she should be considered equally capable of refusing that same treatment.

Sexually Transmitted Diseases Exemption

All states allow minors to access testing and treatment for sexually transmitted diseases without parental consent. In most states, the minor must be at least 12 years old, but some states have a higher age requirement.^35,36 In some states, testing and/or treatment for human immunodeficiency virus may not be included in the exception.

Prenatal and Pregnancy Care Exemption

Many states allow minors to consent to prenatal care and pregnancy-related care. In states lacking such statutes, minors are often provided prenatal care under the mature minor doctrine, particularly if the state allows minors to consent to other reproductive services.^35,36 About two-thirds of the states have laws allowing a minor to consent to treatment for their own child.³⁷

Alcohol or Substance Abuse and Mental Health Treatment Exemption

Nearly all states allow minors to access treatment for alcohol or substance abuse. A majority of states have no specific laws regarding access of mental health services, and of those that do, the range of services that can be accessed varies.³⁸

Sexual or Physical Abuse Treatment Exemption

The evaluation and treatment of sexual or physical abuse without parental consent is generally permitted. In many instances, these patients may be treated under the emergency exemption, because minors who have suffered physical or sexual abuse require prompt treatment. However, assuming that the parents are not the alleged perpetrators, seek parental involvement as early as possible.

PRACTICAL IMPLICATIONS OF TREATING MINORS UNDER STATUTORY EXCEPTIONS OR AS MATURE MINORS

The minor consenting to the treatment is generally responsible for the cost of treatment. Once a minor is treated under one of these statutes, the minor should be afforded the same confidentiality as an adult. In some states, certain exceptions exist if the provider feels that it is in the minor's best interest to have the parent notified. The Health Information Portability and Accountability Act of 1996 (HIPAA) Privacy Rule generally defers to state law or other applicable laws that expressly address a parent's ability to obtain health information about a minor including when a parent agrees to a confidential relationship between the physician and the minor.³⁹ The hospital bill may pose a potential risk for breach of confidentiality if charged to a parent's insurance carrier.

Assent and Refusal by the Older Minor

Providers should seek the assent and cooperation of older or "mature" minors even when parents are granting permission for treatment. If the proposed treatment is nonemergent and the older minor refuses to give assent, the minor's decision should be strongly considered.

WHEN THE MINOR'S INTERESTS ARE NOT BEING PROTECTED

In almost all cases, parents make decisions they believe to be in their child's best interests. However, situations arise when the physician wishes to override or delay the decision making of the parent. For example, if the parent is intoxicated, carefully consider the parent's capacity to give informed consent or refuse care for the minor child. If parents disagree with a treatment plan based on religious or moral reasons, the court or child protective agencies may intervene if the disputed intervention is lifesaving. The American Academy of Pediatrics opposes religious doctrines that recommend opposition to medical attention for sick children and states that children who need medical care to prevent substantial harm or suffering should receive that care.⁴⁰

The ideas of privacy and confidentiality are important elements of ethics, religion, and law because they affirm the dignity and value of the individual.⁴¹ Respect for these rights has been a cornerstone of medicine since ancient times. The Hippocratic Oath reads, "All that may come to my knowledge in the exercise of my profession … I will keep secret and will never reveal." The American College of Emergency Physicians Code of Ethics states that emergency physicians should "Respect patient privacy and disclose confidential information only with consent of the patient or when required by an overriding duty such as the duty to protect others or to obey the law."⁴² The privacy of one's physical person and the privacy of one's personal information (confidentiality)⁴³ are considered together in this chapter. All states and the federal government have laws that govern privacy and confidentiality, including mandatory or voluntary reporting requirements that may override considerations of individual patient privacy and confidentiality.

BARRIERS TO PRIVACY AND CONFIDENTIALITY IN THE ED

ED barriers to privacy and confidentiality include ED physical design, operational issues, the presence of visitors, students, and other individuals, and video technology.

Design and operational issues that impact privacy and confidentiality include the triage area, frequent movement of patients between beds, open ED areas for documentation and work, and patient placement for close observation to minimize risk from falls or self-harm.^41,43 In addition, the growing problems of ED crowding and boarding lead to the use of hallway beds and nontraditional bed spaces, which greatly reduce the ability of staff to provide optimum privacy and confidentiality to patients.⁴⁴ ED staff should be vigilant when conducting interviews, teaching, or communicating to maximize patient privacy and confidentiality.

Students of various disciplines, law enforcement, and visitors should respect patient privacy and confidentiality.⁴⁵ Requests from patients to exclude healthcare students from observation or care should be considered, based on the patient's reasons for the request and the specific situation, but not guaranteed.^41,45 Obtain verbal consent from patients for the presence of students who do not participate in care, and accept refusals.

Law enforcement officials may engage in the collection of evidence and the interviewing of witnesses to crimes in the ED. Except where required by law, patients should have the option of whether or not to speak with law enforcement, and patient information releases, not expressly required by law, require the patient's consent.⁴⁶ Visitors should generally be allowed (as space permits), with consent from the patient.⁴¹ Patients should be asked verbal permission for providers to discuss personal information in front of the visitor. In some cases, disclosure of certain diseases, such as human immunodeficiency virus, to a third party requires a written consent.⁴⁷ Providers should always consider the nature and gravity of the information being related to a patient and should try to give serious or very personal results and diagnoses in private, even if previously given permission to discuss in front of a visitor.

Patients brought to the ED in the custody of law enforcement pose unique challenges. The safety of staff and patients must be balanced with the privacy and confidentiality rights of the individual. The American College of Emergency Physicians recommends providing unbiased, attentive, and complete care to these patients and communicating instructions appropriate to the medical condition to correctional or law enforcement staff as indicated while maximizing patient privacy.⁴⁸

Photography and video performed for the purposes of evidence collection, quality assurance, and documentation may be acceptable under certain circumstances, but patients should give consent except where not required under the law.⁴⁹ Photography and filming for educational and publication purposes always require patient consent. Images recorded for nonmedical or educational purposes without consent (especially with cell phones) are generally prohibited.^50,51 Obtain any necessary permissions from hospital administration and learn and follow all applicable policies and state laws surrounding filming and photography of patients in all circumstances. Cell phones, tablets, and laptop computers with identifiable patient information should be physically secured and protected with a password program, and images should never be sent via unencrypted email.

THE HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT AND PROTECTED HEALTH INFORMATION

Definitions

HIPAA is the most important U.S. law that protects the healthcare privacy and confidentiality of individuals. This legislation required the establishment of standards for the security, exchange, and integrity of electronic health information, and set rules for basic national privacy standards and fair information practices for health care.

The U.S. Department of Health and Human Services produced the "Standards for Privacy of Individually Identifiable Health Information," also called the Privacy Rule, in 2000. The rule has been amended several times with a major revision in January of 2013, commonly referred to as the Omnibus Final Rule.⁵² These rules establish the obligations of "covered entities." Covered entities include "health plans, health care clearinghouses, and health care providers (broadly defined to include anyone who furnishes, bills, or is paid for health care in the normal course of business) and business associates of these entities, who transmit health information in electronic form when dealing with an individual's health information."⁵³ Only those parts of the privacy rule most applicable to emergency providers will be covered here.

Under HIPAA, health information (often referred to as protected health information [PHI]) is "any information, including genetic information, whether oral or recorded in any form or medium that (1) is created or received by a health care provider, health plan, public health authority, employer, life insurer, school or university, or health care clearinghouse; and (2) relates to the past, present, or future physical or mental health or condition of an individual; the provision of health care to an individual; or the past, present, or future payment for the provision of health care to an individual."⁵³ HIPAA also applies when PHI is transmitted or maintained by a covered entity. The rule also discusses individually identifiable health information, including demographic data such as name, Social Security number, date of birth, and other identifiers that "identify the individual or for which there is a reasonable basis to believe can be used to identify the individual."⁵³

Disclosure of Protected Health Information

PHI should be shared with the clear understanding that only the minimum amount of information required to accomplish the purpose of the disclosure will be released. These "minimum" necessary standards do not apply to information that is given to patients themselves, used for treatment, or required by law.⁵⁴ Covered entities should have procedures in place, including limitations on access to electronic medical records, to ensure that users are able to obtain only that information necessary to their job or business purpose.

HIPAA allows covered entities to use PHI, without authorization, for purposes of treatment, payment, and operations. Treatment is the provision, management, and coordination of health care and related services, including consultations and referrals.⁵⁵ The payment exclusion allows a healthcare provider to use PHI to obtain payment or be reimbursed for the care provided to an individual.⁵⁵ Operations include a number of activities, including, but not limited to, quality improvement, employee evaluation and credentialing, auditing programs, and business activity such as planning, development, management, and administration.⁵⁵ An exception to this rule is that psychotherapy notes often require written consent for their use except for treatment, certain legal matters, and the protection of the public from a serious threat.⁵⁶

There are 12 national priorities, as shown in Table 303-3,^57,58 in addition to treatment, payment, and operations usage, for which covered entities are allowed to disclose PHI without authorization. These disclosures are permitted by the law and have specific conditions or limitations to balance the privacy of the individual and the public interest for the information.⁵⁷

Under the privacy rule, the risk of every possible incidental use or disclosure of PHI does not have to be eliminated.⁵⁷ Provided the incidental disclosure or use occurs as the unintentional result of a legitimate use or disclosure of PHI, the entity has in place reasonable safeguards (as defined in the rule), and has applied the minimum necessary standard, there is likely to be no violation of the rule.⁵⁹

Patient Rights to Protected Health Information

The HIPAA regulations also require that a notice of privacy practices be given to all patients, informing them of their rights regarding their health information.⁶⁰ Patients are asked to sign these documents and receive a copy of the notice.

These rights to PHI include access to records in the patient's preferred format, request for amendments, request for additional restrictions, notice of PHI use, and an accounting of disclosures made from their PHI.^61,62,63,64 In general, most of these functions will be handled by a hospital's medical records department, but requests to amend records must be addressed by the provider promptly (60 days). If the request is denied, the patient has the right to place a written statement in the medical record disagreeing with the denial.⁶¹

Law Enforcement Rights to Protected Health Information

HIPAA allows the limited release of PHI for certain law enforcement purposes. Release is permitted to respond to a judicially issued warrant, subpoena, court order, or grand jury subpoena. Release is allowed to assist law enforcement in identifying or locating a suspect, fugitive, material witness, or missing person by releasing only the following information: "name and address, date and place of birth, Social Security number, ABO blood type and Rh factor, type of injury, date and time of treatment, date and time of death, if applicable, and a description of distinguishing physical characteristics, including height, weight, gender, race, hair and eye color, presence or absence of facial hair (beard or moustache), scars, and tattoos."⁶⁵ Providers may notify authorities of a person's death if a possible criminal activity was the cause of the death. PHI may be released in response to law enforcement requests for information about a victim or suspected victim of crime, with the patient's consent. When a patient, who may be a victim of a crime, is unable to consent, the provider may release information to law enforcement if they believe the release is in the patient's best interests and that the information is not intended to be used against the patient by law enforcement.⁵³

Impact of Protected Health Information on Emergency Physicians

HIPAA allows for open discussions with primary providers, consultants, and other persons involved in the care of an individual. Primary providers are allowed to discuss a patient, without first obtaining the patient's consent, if the patient is under their care in the ED. Providers are able to release information under the national priorities and as required under state law. If family or friends call and ask about a patient by name, "directory" information may be released unless the patient has requested they not be listed in the directory. Providers are cautioned about releasing additional information over the phone unless they can reasonably confirm the identity of the caller and, if possible, have the patient's permission to release additional health information.

Do not access records for which you are not the treating provider, unless such information is needed for operations, for law enforcement, or for another legitimate reason. Document the reason for access to any chart where you are not the treating provider. Failure to comply with these regulations can lead to significant monetary and even criminal penalties for providers. See Table 303-4 for some HIPAA do's and don'ts.

Need to Report Protected Health Information

Privacy and confidentiality are not absolute rights. Ethicists, courts, and legislators have agreed that in some situations, the rights of the individual are overridden by the needs of the public. In many cases, this takes the form of permitted or mandatory reporting of certain diseases, pathogens, forms of abuse, and other medical conditions or situations. Providers should balance confidentiality, patient autonomy, the public good, and legal mandates with possible sanctions for noncompliance and medical-legal risk when deciding when to report a given condition.

Abuse All states require the reporting of suspected child abuse or neglect and generally give providers legal protection as long as reports are made in good faith.⁴³ Most states have similar reporting requirements for elder abuse. Some of these laws only pertain to those elderly patients who are incapacitated or in care facilities, whereas other states include all persons above a certain age.⁶⁶ Mandatory reporting laws for domestic partner violence have been passed in a few states. In some domestic violence cases, reporting may be required based on state laws that mandate reporting of injury during the commission of a crime or injuries from deadly weapons.^67,68 Key to the reporting of all types of abuse is the willingness of the provider to consider and discuss potential abuse cases with patients.^67,69

Injury by Deadly Weapon or due to a Criminal Act Most states mandate the reporting of injuries from deadly weapons, including stab and gunshot wounds.⁶⁷ A number of states also require reporting of injuries that occur as a result of a criminal act but do not require reporting of so-called "victimless" crimes such as drug abuse.⁴³

Driving Impairment Many patients have medical conditions that may cause care providers, family, and the public to question their ability to safely operate motor vehicles. In some states, providers are required to report drivers with epilepsy to the department of motor vehicles. Patients with a variety of other medical conditions, such as dementia, vision impairment, Parkinson's disease, and other degenerative conditions, as well as patients on certain medications, may be unable to safely operate a vehicle.⁷⁰ A majority of states provide physicians with immunity when reporting impaired drivers. In other states, immunity is not provided, and providers could be found liable for damages resulting from reporting or nonreporting.⁶⁷ Many providers have concerns about reporting these patients, and the American Academy of Neurology supports optional reporting of medically impaired or potentially impaired drivers.⁷⁰ A study of California emergency physicians found very low reporting rates in compliance with a state law requiring physicians to report all patients with lapses of consciousness.⁷¹ In addition, some states require that providers report drivers who are in accidents while intoxicated.⁶⁷

Infectious Disease Reporting The U.S. federal government requires the reporting of contagious diseases for surveillance purposes.⁴¹ The annual lists of diseases and conditions under national surveillance are available on the Centers for Disease Control and Prevention website.⁷² Pathogens on this list commonly encountered by emergency providers may include Chlamydia trachomatis, gonorrhea, viral hepatitis, human immunodeficiency virus, Lyme disease, pertussis, and resistant Streptococcus pneumoniae. Other pathogens, such as methicillin-resistant Staphylococcus aureus, may be reportable to other databases or to state health departments. The diseases under surveillance change as new pathogens are discovered and priorities change; other diseases are deleted from the list as they lose relevance.

Reporting of Medical Errors A number of states and organizations have enacted a combination of mandatory and voluntary reporting systems in an attempt to improve healthcare processes and reduce patient morbidity and mortality due to hospital errors and adverse events.⁷³ Providers should comply with these systems as required by law.

Reporting of Breaches and Penalties under HIPAA

Under HIPAA, any disclosure, access, or use of PHI in a manner not permitted under the law is assumed to be a breach.⁷⁴ The covered entity must demonstrate that there is a low probability that the PHI has been compromised based on a risk assessment or face penalties. If a breach is found, notification may be required to the party whose information was compromised, the secretary of the Department of Health and Human Services, and in the case of large breaches the public at large.^75,76,77 Penalties for violation of HIPAA range from $100 per violation if the covered entity was unaware of the violation and should not reasonably have been aware to $1.5 million per violation if the breach was considered due to willful neglect and not adequately addressed in the required time frame.⁷⁵ Federal law also provides for criminal penalties of up to 10 years in jail and $250,000 in fines for HIPAA violations.⁷⁸ Providers are strongly encouraged to discuss with their attorney or hospital privacy officer or legal counsel any potential HIPAA violation immediately upon learning of a potential breach to minimize the risk of penalties against providers and organizations.

Congress enacted EMTALA in 1985 in response to situations where hospitals refused care to uninsured patients.

EMTALA OBLIGATIONS

EMTALA imposes numerous obligations on hospitals operating EDs. These include the provision of a "medical screening exam," performed by "qualified medical personnel," to look for an "emergency medical condition" (EMC) for all patients who "come to the ED" seeking care for a medical condition. If an EMC is found, the patient must be stabilized (as defined under EMTALA) within the capability of the hospital or transferred, in a specified manner, if necessary, to complete stabilization. Each element will be considered in turn.

"Comes to the ED"

Under EMTALA a "dedicated emergency department" is "any department or facility of the hospital, regardless of whether it is located on or off the main hospital campus that": (1) is licensed by the state as an emergency room or ED; (2) is held out to the public as providing unscheduled care for EMCs on an urgent basis; or (3) provides one-third of its outpatient visits for the treatment of EMCs on an urgent, unscheduled basis.⁷⁹ Many hospital-owned urgent care centers may meet this definition.

Hospitals must provide a screening examination to any patient who comes to the "dedicated ED" (hereafter "ED") and requests, or has a request made by another, for evaluation or treatment of a medical condition. If a prudent layperson observer would believe the person needed evaluation or treatment for a medical condition, the hospital's obligation under EMTALA is triggered.⁷⁹ Note that the language says for a "medical condition," not an "emergency medical condition." Other hospital locations, such as labor and delivery, psychiatric intake areas, and urgent care areas, which meet the above definition, are subject to EMTALA obligations as well.⁸⁰ An infant born alive is considered an individual under the law, and therefore, the same EMTALA obligations apply, including when the infant was born in the ED.³¹

Emergency Medical Condition

An EMC is a "medical condition manifesting itself by acute symptoms of sufficient severity (including severe pain, psychiatric disturbances and/or symptoms of substance abuse) such that the absence of immediate medical attention could reasonably be expected to result in: 1) Placing the health of the individual (or, with respect to a pregnant woman, the health of the woman or her unborn child) in serious jeopardy; 2) Serious impairment to bodily functions; or 3) Serious dysfunction of any bodily organ or part; or with respect to a pregnant woman who is having contractions: 1) That there is inadequate time to effect a safe transfer to another hospital before delivery; or 2) That transfer may pose a threat to the health or safety of the woman or the unborn child."⁷⁹ For pregnant women with contractions, an EMC exists if there is insufficient time to transfer the patient before delivery or the transfer may pose a risk to mother or child.⁷⁹ Ultimately, this is a medical decision. If it is determined that no EMCs exists, then EMTALA no longer applies to that patient. It is good practice to note the time that this decision was made. The courts have generally ruled that the physician must be aware an EMC exists before he or she is liable under EMTALA. It is important to understand that for an EMC to be present the patient must have a condition such that the lack of immediate medical attention could result in the consequences outlined above. The rule does not suggest that any particular symptom, including severe pain, is in and of itself an EMC, only that the presence of such symptoms mandates a screening, as described below, to determine if the patient has an EMC.⁸¹

Medical Screening Examination

A medical screening examination is the process required to reach, with reasonable clinical confidence and based on the patient's presenting signs and symptoms, the point at which it can be determined whether an EMC does or does not exist.³¹ This may involve a simple process, such as a brief history and physical examination, or a complex process involving ancillary studies, consultants, and procedures.³¹

The screening must be the same for every patient presenting with similar symptoms or complaints to be EMTALA compliant. The courts have generally held that so long as screening examinations are performed in a consistent manner across all patients and in accordance with a hospital's own policies, the EMTALA screening obligation has been met.⁸⁰ This is true even in cases of misdiagnosis. The courts have also held that misdiagnosis and the adequacy of screening are issues of negligence and should be addressed under state malpractice statutes. Nurse triage does not meet the hospital obligation to provide a medical screening examination.⁸⁰

EMTALA dictates that a hospital may not delay the screening examination and stabilizing treatment to inquire about method of payment or insurance status.⁸² Hospitals may follow reasonable registration procedures, including inquiring about insurance, provided that it does not delay the medical screening examination or discourage patients from remaining for evaluation.⁸² Requests for copayments or down payments should be deferred until after the screening examination and any indicated stabilization to avoid the appearance that the request for payment could have deterred a patient from continuing to seek care. Similarly, advance beneficiary notices and managed care organization authorizations should be deferred.⁸⁰

Providers are allowed to contact a patient's personal physician for advice regarding the patient's history, treatment, and evaluation (but not to obtain prior authorization) as long as this does not delay the medical screening examination.⁸³

Qualified Medical Personnel

The statute states that "The examination must be conducted by an individual(s) who is determined qualified by hospital bylaws or rules and regulations."⁸⁴ These individuals must be formally recognized by the hospital governing body as qualified to perform this type of examination.³¹ Although the regulations do not specify what type of provider (e.g., registered nurse, medical doctor, physician's assistant) should perform the medical screening examination, the qualifications of the provider may be retrospectively reviewed and found inadequate.⁸⁰ The regulations specifically allow a certified nurse midwife to certify false labor.⁷⁹

Stabilized

The concept of stabilization under EMTALA is not what most clinicians would expect. To have a duty to stabilize, the treating providers must be aware of the presence of an EMC. Under EMTALA, stabilize means to provide "treatment as necessary to assure, within reasonable medical probability, that no material deterioration of the condition is likely to result from or occur during the transfer of an individual from a facility or that … the woman has delivered the child and placenta."⁷⁹ Stabilization does not require that the underlying medical condition be resolved. For example, a patient with difficulty breathing and a history of asthma may be stable once provided with medication and oxygen, despite the fact that the underlying condition of asthma is still present.⁸⁵

The decision regarding whether or not the patient is stable rests with the physician actually treating the patient.^86,87 However, this decision is subjective and may be reviewed with medical hindsight. In an investigation, the burden of proof for stability rests with the transferring hospital.

After stabilization, EMTALA no longer applies, and patients may be discharged or admitted for further care. Once a patient is admitted to inpatient status in good faith, not just for the purposes of avoiding EMTALA obligations, the admitting hospital's EMTALA duty is considered complete.⁸⁸

Transfers in accordance with local protocols, such as a trauma system protocol, will generally meet the stabilization requirement, but the transferring hospital must stabilize within its means first.³¹ If a hospital is unable to stabilize the patient, then transfer to a higher level of care is appropriate, and all efforts made to stabilize by the transferring hospital should be documented in the patient chart.³¹

The U.S. Supreme Court has ruled that the hospital or physician does not need to have an improper motive for a transfer to be successfully sued for failure to stabilize under EMTALA.

Below are the definitions for two specific situations (discharges and psychiatric patients) as written in the State Operations Manual used by EMTALA investigators.

Stable for Discharge "Discharge home with follow-up instructions. An individual is considered stable and ready for discharge when, within reasonable clinical confidence, it is determined that the individual has reached the point where his/her continued care, including diagnostic work-up and/or treatment, could be reasonably performed as an outpatient or later as an inpatient, provided the individual is given a plan for appropriate follow-up care as part of the discharge instructions. The EMC that caused the individual to present to the dedicated ED must be resolved, but the underlying medical condition may persist. Hospitals are expected within reason to assist/provide discharged individuals the necessary information to secure the necessary follow-up care to prevent relapse or worsening of the medical condition upon release from the hospital."⁸⁵

Therefore, the availability of follow-up and content of discharge instructions may be reviewed should a complaint trigger an investigation. One area where this is problematic is follow-up for uninsured patients. An emergency physician may be liable for a violation, for not requiring an on-call specialist to come in, if a patient is referred for needed follow-up care, such as fracture reduction, and is subsequently refused care—if the emergency physician was aware, or should have been aware, that the follow-up was unlikely to occur. Should there be any question about the patient's ability to obtain the needed follow-up care, the specialist should be asked to come to the ED to see the patient and provide the needed care.⁸⁶

All discharge instructions should educate patients to return to the ED if they have any problem accessing follow-up care as planned.

Psychiatric Patients "Psychiatric patients are considered stable when they are protected and prevented from injuring or harming him/herself or others. The administration of chemical or physical restraints for purposes of transferring an individual from one facility to another may stabilize a psychiatric patient for a period of time and remove the immediate EMC, but the underlying medical condition may persist, and if not treated for longevity the patient may experience exacerbation of the EMC. Therefore, practitioners should use great care when determining if the medical condition is in fact stable after administering chemical or physical restraints."⁸⁵ Psychiatric patients present one of the greatest challenges under EMTALA due to the difficulty of determining stability and the lack of available psychiatric resources in most communities.

Transfers

Under EMTALA, transfer is "the movement (including discharge) of an individual outside a hospital's facilities at the direction of any person" representing the hospital, regardless of that person's employment status with the hospital.⁷⁹

Hospitals are expected to appropriately transfer patients if they do not possess either the "capability" or "capacity" to care for the patient. Capability would include the availability of technology, specialists with the needed skills to care for a patient, and equipment or supplies required by the patient's condition. Capacity looks at numbers and availability of qualified staff, beds, and equipment and what the hospital "customarily does to accommodate patients in excess of its occupancy limits."⁷⁹ Therefore, if a hospital routinely opens extra beds to accommodate patients, they must do so if necessary to avoid the transfer of a patient for whom they could otherwise provide care.

Hospitals may not transfer a patient who has not been stabilized unless an appropriate transfer is performed and either (1) the patient requests the transfer and the request is documented in writing, including the patient's awareness of the risks and benefits of the transfer; or (2) a physician documents that the medical benefits of transfer to a hospital with greater resources reasonably outweigh the increased risk to the patient, pregnant woman, or unborn child.⁸⁹ An "appropriate transfer" is defined in the EMTALA regulations. The following four elements are required for an appropriate transfer.⁸⁹

1. The transferring hospital stabilized the patient and, when applicable, the unborn child to the best of its ability, minimizing the risks of the transfer to the patient or, in the case of a woman in labor, her unborn child.

2. The receiving (accepting) hospital has the capability and capacity to care for the patient and agrees to accept the individual and provide appropriate medical treatment.

3. The transferring facility sends all pertinent medical records, including test and study results, treatment provided, and the written consent for the transfer. Information not available at the time of transfer must be sent as soon as possible. If the transfer is necessary due to the failure of an on-call physician to appear, that physician's name and address must be provided to the accepting hospital.

4. The transfer must be performed through qualified personnel and transportation as determined by the transferring physician. The accepting facility may not condition its acceptance on the use of a specific transport service or method.^87,90

If a hospital attempts to transfer a patient to meet its EMTALA obligation and the patient, or person acting on the patient's behalf, refuses the transfer, then the hospital's EMTALA obligation is considered met. The hospital is expected to attempt to obtain written informed refusal, including a discussion of the risks and benefits of the refusal of transfer and describe both the facts of the transfer that was proposed and the stated reasons for refusal.⁹¹

Hospitals may not penalize a provider who refuses to authorize the transfer of a patient with an unstabilized EMC or take negative action against any employee who reports a violation of EMTALA.⁸⁹

Duties of Receiving Hospitals

A hospital with specialized capabilities or facilities such as (but not limited to) burn units, trauma units, or regional referral centers may not refuse to accept a transfer from a referring hospital anywhere in the United States when the patient in question requires the specialized capabilities and the receiving hospital has the capacity to treat the patient.⁹² The failure of centers with specialized capabilities to appropriately accept patients requiring their services has been colorfully referred to as "reverse dumping." This rule applies even if the receiving hospital does not have its own dedicated ED.⁹²

Due to the risk of a citation or lawsuit should a hospital with specialized or higher level services fail to accept a transfer as required by the law, some authors suggest that all transfers be accepted by hospitals with specialized conditions without inquiry into the patient's insurance status.⁸⁶ Should the accepting hospital find that the transfer was not appropriate or improperly motivated, it is both their duty and remedy to report the transferring hospital for a potential violation of EMTALA.^86,93 Delays in accepting a patient in transfer who has an unstabilized EMC to receive or confirm financial information may be considered an EMTALA violation by the receiving hospital.⁹⁴

Failure to report an EMTALA violation is itself a violation.

On-Call Responsibilities

Hospitals are required to maintain an on-call list of physicians "who are on the hospital's medical staff or who have privileges at the hospital, or who are on the staff or have privileges at another hospital participating in a formal community call plan in accordance with the resources available to the hospital."⁹⁵ The call list must specifically name an individual physician with accurate contact information, not solely the name of a group or specialty.⁹⁶ The stipulation that the hospital provide these services "in accordance with the resources available to the hospital" leaves considerable leeway for hospitals to decide what services to offer. Physicians who are formally on call must assist when requested to determine if an EMC exists, to help stabilize patients, and to accept appropriate transfers. They must do this in a reasonable amount of time.³¹ Although regulations allow for physicians to be on call at multiple hospitals and to perform elective surgery while on call, a clear plan must exist to provide EMTALA care in these situations.⁹⁷ It is the responsibility of the emergency physician to determine if the on-call provider needs to appear in person to see a patient. In general, EMTALA does not allow patients to be sent to private physician offices for examination or stabilization, except possibly in cases where the office is part of the hospital-owned facility and on campus with the hospital. One exception may be that of ophthalmologists, who often have specialized equipment not available in many EDs. Hospitals that allow physicians to selectively take call only for their own established patients who present to the ED must ensure the availability of adequate on-call services to all ED patients requiring similar care.⁹⁶ If the on-call doctor will not come after substantial efforts from the emergency provider, then the patient should be transferred to receive necessary care. The emergency provider must inform the accepting hospital that is why the patient is being sent and provide them with the on-call doctor's name and address (failure to do so is an EMTALA violation).

The widespread adoption of communications technology has made consults by a variety of electronic methods increasingly common. There is no restriction to the use of any means of communication with consultants.⁹⁶

Table 303-5 outlines some EMTALA do's and don'ts.

ENFORCEMENT OF EMTALA

The U.S. Department of Health and Human Services is responsible for enforcing EMTALA at the federal level. A complaint is required to initiate an investigation of a hospital for an EMTALA violation. The complaint may come from a patient, hospital, hospital employee, or anyone who thinks care has been denied someone inappropriately. Hospitals may not penalize employees who report violations.⁸⁹ Punishments under EMTALA can be severe and may include a hospital's exclusion from participating in Medicare and Medicaid in addition to substantial fines. Providers found to violate EMTALA can also be fined and/or excluded from federal programs, making them nearly unemployable.⁹⁸

Physicians, particularly on-call physicians, are relatively unaware of their obligations under EMTALA,⁹⁹ and hospitals should educate their staff regarding EMTALA.⁸⁸ An EMTALA violation does not imply medical malpractice.

Situations Where EMTALA Does Not Apply or Ceases to Apply

Once a patient is admitted, in good faith, as an inpatient to the hospital for further care, EMTALA ceases to apply. However, EMTALA still applies to patients in the ED and patients on observation status such as patients in an ED chest pain unit, an observation area of labor and delivery, or in observation status within the main hospital even if they are on a unit that also contains patients on inpatient status.^80,87,100 Although Centers for Medicare and Medicaid Services regulations do identify that under the above conditions EMTALA does not apply to inpatients, the subject is not settled law as far as the courts are concerned, so careful documentation of why patients were admitted (to validate the good faith clause) and what status they were in the hospital on (to validate that they were an inpatient) is very important.¹⁰⁰ Inpatients who subsequently develop an EMC are not covered by EMTALA, even if they are physically moved back to the ED; however, they are covered by the Medicare Conditions of Participation. EMTALA does not apply to outpatients who have already begun a scheduled appointment. EMTALA may not apply during a declared national emergency or pursuant to a state emergency or pandemic preparedness plan following the issuance of a waiver under law.¹⁰¹

Ambulance "Parking"

Prolonged delays in moving patients from EMS care to hospital care, referred to as "parking," is not acceptable and may be considered a violation.⁹⁰ This does not mean that every ambulance patient must instantly be taken from the care of EMS, particularly in instances where the hospital may lack capacity or capability to immediately care for the patient.⁹⁰ The hospital has an EMTALA obligation to the patient once on hospital property.

Patient-Initiated Transfers

Any transfer not for medical reasons is considered a patient-requested transfer. The chart should reflect the patient's reason for wanting the transfer. The transfer must still be an "appropriate transfer."

Use of the ED for Nonemergency Services

If a request is made by, or for, a patient presenting for treatment of a medical condition but the "nature of the request makes it clear that the medical condition is not of an emergency nature, the hospital is required only to perform such screening as would be appropriate for anyone presenting in a similar manner to determine" if an EMC exists.¹⁰²

Withdrawal of Request for Screening

Patients who fail to start or complete the screening and treatment process fall into one of three categories: patients who arrive at the ED and then fail to even begin their medical screening examination (often classified as left without being seen or left before examination); patients who leave or "elope" without informing staff at any point during the evaluation¹⁰³; and patients who refuse recommended treatment or admission and leave "against medical advice."

In each scenario, the hospital should make a clear, well-documented effort to find a missing patient by overhead paging and a search of the department. The medical record should contain a description of the services offered (examination and treatment) that were refused. The hospital should take all reasonable steps to procure the individual's written refusal on a document that also outlines the risks and benefits of examination and treatment. These issues are very important under EMTALA, as regulations state "that hospitals should be very concerned about patients leaving without being screened. Since every patient who presents seeking emergency services is entitled to a screening examination, a hospital could violate the patient antidumping statute if it routinely keeps patients waiting so long that they leave without being seen, particularly if the hospital does not attempt to determine and document why individual patients are leaving, and reiterate to them that the hospital is prepared to provide medical screening if they stay."

Triage Down

Downgrading a patient's triage level from the level required under hospital protocol risks an EMTALA citation and could form the basis for a civil lawsuit.^103,104

State Law

Some states have passed laws that impose additional duties or requirements on emergency physicians and hospitals. Such laws should be followed unless they directly conflict with the federal EMTALA rule, in which case the federal statute takes precedence.

Requests for Testing

In some cases, patients may present to the ED for testing, such as x-rays or blood work, under the order of their personal physician. Because these patients are not requesting examination or treatment of a medical condition, EMTALA does not apply. Should the hospital choose to provide the patient with the testing services, these patients should be differentiated from standard ED patients. Separate paperwork defining consent, that a medical screening examination was not requested (signed by the patient), and interactions with the ordering physician should be recorded. Patients who independently present for testing, such as pregnancy testing, should receive a medical screening examination before testing, and if they refuse the screening examination, they should be referred elsewhere for the requested testing.

A common scenario is the patient brought in by law enforcement for alcohol or drug screening. In these cases, if it appears that the patient should be screened (prudent layperson) or the patient or police request an examination, then the screening examination should be done.

Screen Away Programs

Such programs aim to comply with the letter of the EMTALA law by performing medical screening examinations and then either sending away those patients found not to have an EMC or requesting payment before treatment. The ethical implications of these programs are beyond the scope of this chapter. Physicians and hospitals should consider the legal risk and ethical and moral implications of such programs, particularly in those cases where alternative sources of care are not provided.¹⁰⁵

Private Patients in the ED

In some EDs, it is common for staff physicians to send their patients to the ED, with plans to meet the patient in the ED. Although this is acceptable, these patients should go through the standard triage process, and if any concern exists about the presence of an EMC, patients should be evaluated in the standard manner by the emergency physician present and stabilized while waiting for the private physician.

"The Guarantee"

Some hospitals have begun programs in which they promise a patient will be triaged or seen by a doctor within a specific amount of time. These guarantees are problematic from an EMTALA point of view, as the hospital will likely be held to these times during an investigation.

Pain and EMTALA

An epidemic of prescription drug abuse in the United States has led to substantial risk for patients and growing difficulties for providers.¹⁰⁶ Legislation both enacted and pending in many states attempts to address this problem, often placing emergency physicians in a difficult position.¹⁰⁶ While EMTALA indicates that pain may be a symptom suggestive of an EMC, it only requires that the patient with pain receive a medical screening exam consistent with the patient's presenting complaints. Once a patient has been identified as not having an EMC, providers can make reasoned clinical determinations about the appropriateness of opioids and other medications. The Centers for Medicare and Medicaid Services has clarified that the posting of signage that, even when intended as education, discusses restrictions on ED prescribing or use of opioids may discourage patients from receiving their medical screening exam and therefore would be in violation of EMTALA.¹⁰⁷ Providers and staff should also not discuss with patients the results of state pharmacy database queries prior to the completion of the medical screening exam to prevent the patient from feeling coerced not to complete their exam.¹⁰⁷ The best course in dealing with patients with painful complaints is to provide a medical screening exam each and every time they present to the ED, and once an EMC is determined not to exist, to treat the patient as clinically appropriate based on the clinical scenario, risk for pharmaceutical abuse, and applicable state law.¹⁰⁶

The ED presents a unique setting in health care where numerous factors interact to create the potential for error.^108,109 These errors can create adverse outcomes for patients and increased medical-legal risks for ED providers. Risk management is the process of identifying and mitigating factors that may be a source of errors. This section will focus on important sources of error in the ED and suggestions for the individual provider to mitigate risk within the confines of their existing care setting.

Studies looking at data from malpractice lawsuits have consistently found that certain presenting complaints and disease processes are associated with poor outcomes leading to legal action. These are summarized in Table 303-6.^{108,109,110,111}

The error types most commonly reported in emergency medicine include diagnostic error or delay, treatment error or delay, improper performance of procedure or treatment, misinterpretation of tests, failure to supervise or monitor a case, and a failure or delay to consult or refer.^108,110 Of these, diagnostic error, which includes failure to diagnose, delay in diagnosis, and wrong diagnosis, is consistently the most frequent and costly, in terms of malpractice claims paid, both in emergency medicine and across all specialties.^108,109,112 Diagnostic error can be defined as a diagnosis that is "missed, wrong, or delayed."¹¹³ These errors lead to permanent injury or death in almost half of filed malpractice cases related to diagnostic error.¹⁰⁹

One study evaluated the sources of these diagnostic errors in the ED.¹¹¹ The study found that cognitive errors encompassing errors in judgment, knowledge, and vigilance or memory contributed to 96% of claims with identified errors. Communication errors, particularly as they relate to patient handoffs, were involved in 35% of diagnostic errors. System errors, including issues with supervision, workload, and fatigue, were noted in 37% of cases; these errors were more prevalent where students or residents were involved. Patient-related factors were involved in an additional 34% of cases. Of note, two-thirds of the errors involved cases in which more than one provider participated in the patient's care, further suggesting the importance of communication-related factors.

REDUCING RISK

Improving patient safety and reducing risk in emergency medicine requires a broad focus involving multiple disciplines and addressing numerous issues including, but not limited to, medication administration, electronic health records, ED staffing, flow, and culture, and available equipment and resources.^108,109 Although these systemic changes are often beyond the ability of the individual physician to influence, there are a number of steps each physician can take to reduce the risk of error and of being named in a malpractice suit. Providers can address both interpersonal and clinical issues that may reduce risk.

Some actions that providers can take to establish a good patient–provider relationship are noted in Table 303-7.¹¹⁴ This relationship is key to facilitating good communications and reducing risk. Introductions are simple and important. Tell the patient your name and your place on the healthcare team (e.g., attending or supervising doctor, resident physician, student). Engage the family in addition to the patient, when appropriate and permitted by the patient. Ensure that the patient and family or caretaker understand the diagnosis and discharge instructions, particularly those related to follow-up, treatment, and when to return to the ED. The physician should, whenever possible, personally review the discharge instructions with patients and provide the opportunity for patients and caregivers to ask questions prior to discharge to ensure comprehension.

Providers can also work to change other practice behaviors that may perpetuate or lead to error and risk. Patient handoffs are a significant area of risk for patients and providers. Avoiding limited or rushed patient handoffs and bedside transfers of care, when possible, may reduce the risk associated with shift change and multiple providers on the care team. Providers may fail to consider all the diagnostic possibilities in a transferred or signed-out patient because they receive the patient with a preexisting plan and diagnosis. It is a good practice for providers to meet each patient signed out to them and to evaluate them at least once before discharge.¹¹⁵ Errors around procedures were the second highest category of error in one ED study.¹⁰⁸ Provide adequate supervision of residents and students performing procedures, provide comprehensive informed consent for every procedure when possible, and follow established best practices and guidelines when present or available for a given procedure to reduce this risk. Avoid criticizing the care provided by other providers, and never make guarantees about patient outcomes.

SPECIFIC HIGH-RISK DIAGNOSES AND TREATMENTS

Certain diagnoses, covering a wide variety of systems and mechanisms, present a high risk to emergency providers, as noted in Table 303-6. Providers should be aware of these diagnoses and their atypical presentations and consider the possibility of a high-risk problem in every patient. Avoid placing a diagnosis on a patient without sufficient clinical certainty. When a diagnosis is uncertain, describe the patient's assessment with symptoms.

The optimal treatment of certain diseases is unclear. Numerous situations exist in which the standard of care is not well defined. Providers should have careful and well-documented discussions with patients and families about what treatments are or are not being given, and why. Although the management of risk and errors in emergency medicine is highly complex, each physician should take it upon himself or herself to do what they can to reduce risk in their own practice and behavior.

The registration of death is a state function governed by the laws and regulations of the state in which the death occurs. The death certificate is the permanent record of the fact of the death. Information from the death certificate is used as the source for many health statistics, to help determine funding for research, and to help settle the estate of the deceased, and in some states, it is required to get a burial permit.¹¹⁶ To ensure consistency of the data reported to the National Vital Statistics System, a standard death certificate was created, and all state certificates conform closely to the standard.

The patient's personal (attending) physician usually fills out the death certificate. This physician likely knows the patient better than other healthcare providers and is in the most favorable position to certify the cause of death.¹¹⁷ In cases in which there is no primary physician and the patient dies in the ED, the emergency physician may be called on to certify the death. Despite the fact that many death certificates contain errors in the assessment of cause of death, a search of the literature has not revealed any reports of physician liability for death certificate errors.¹¹⁸ In many ED cases, the death will require referral to the coroner or medical examiner's office to certify the death. Cases requiring referral vary by state but may include the situations listed in Table 303-8.

The physician who completes the certificate is required to fill out the document in a timely fashion, often within 24 to 72 hours, using black ink and legible writing. In addition to documenting the time and date of death, the physician should indicate an opinion as to the immediate and underlying causes of the death. The immediate cause of death is the final entity causing death. The underlying cause of death is the original condition or diagnosis from which the chain of events leading to death originated. The chain of events should be listed on the certificate from most recent to the final, underlying cause.¹¹⁸ The manner of death (e.g., natural, accident, homicide) and other significant but not directly linked conditions should be listed separately. In cases in which the disease processes involved are unclear, in some states physicians may qualify their opinions by listing them as "probable."

Terminal events such as cardiac or respiratory arrest should not be listed as the proximate cause of death because they do not indicate the disease process that caused death.

All U.S. states, the District of Columbia, and Puerto Rico have enacted laws allowing a mother and, in some states, either a custodial parent or an agent of the parent to leave a newborn infant at a "safe haven" in an attempt to reduce the numbers of infanticides and abandonments of children in unsafe places.¹¹⁹ These laws vary with respect to who may leave the infant, how long after birth the child may be left, whom the child may be entrusted to, and the amount of legal protection and anonymity due the person leaving the child.¹¹⁹ In most states, a healthcare provider or emergency services provider is authorized to accept the child.¹¹⁹ Providers should be aware of the laws in their state, and every ED should have a policy to deal with this situation.

The Tarasoff ruling set the precedent that a physician owes a duty to a foreseeable third party when the physician is aware of a reasonable risk to that individual. Over the years, courts have extended that duty to include an obligation to warn or protect others against a variety of dangers, including communicable diseases, impaired drivers, employment physicals, and medication or treatment reactions.¹²⁰ Physicians have varying obligations and protections under state laws for reporting patients and warning potential victims or authorities when third parties may be at risk.¹²¹ Good patient education, including medication side effects, driving and work restrictions, and strict compliance with state reporting laws, is a good start to minimize this risk.

Calls for telephone advice should be routed to an established "advice line" operated by the hospital, an insurer, or other entity. By dispensing telephone medical advice, a physician may inadvertently enter into a binding physician–patient relationship.¹²² ED staff should be taught a standard response to unsolicited phone calls from the general public: they should state that they are not allowed to give advice over the phone and should encourage the patient to come to the ED for evaluation and treatment.¹²³

Emergency providers can be exposed to liability extending beyond the ED. Two common sources of this risk are the writing of inpatient orders and responding to emergencies elsewhere in the hospital.¹²⁴ Emergency physician orders that cover any part of the inpatient stay are risky because there is a lack of clarity about when the transfer of care to the inpatient provider takes place. The American College of Emergency Physicians recommends that the emergency physician not be compelled to write any orders extending outside of the ED and that medical staff policies provide for timely orders for and evaluation of admitted patients by the inpatient medical staff.¹²⁵

In some EDs, the emergency physician is expected to address a variety of medical issues that may arise on the inpatient floors.¹²⁴ Hospitals are responsible for the treatment of inpatients and should not rely on the ED physician to care for inpatients. In cases in which no other option is available, inpatients could be brought to the ED for evaluation and treatment.¹²⁶

Physicians are generally expected to exercise reasonable care and practice within the accepted standard of care. A failure to do so is considered negligence and is the standard used in most medical malpractice lawsuits. Efforts to protect the healthcare safety net provided by EDs and specialists treating ED patients have led some states to enact a more rigorous standard of negligence for care provided in the ED. This standard is often referred to as "gross negligence." Gross negligence is more serious than negligence and has various definitions across jurisdictions that include "conduct so reckless as to demonstrate a substantial lack of concern for whether an injury results" and a "failure to exercise slight care or diligence."^127,128 The term reckless is sometimes used to describe a standard of negligence and generally seems to be equivalent to gross negligence.¹²⁷ A third standard, "willful or wanton" misconduct, although not universally seen as separate from the "gross negligence" standard, is often found in "Good Samaritan" laws.^127,129 "Willful or wanton" misconduct suggests behavior "where someone knew that an injury was likely to result from an action and, despite this knowledge, acted with a conscious disregard for the safety of another person."¹²⁷ The "willful and wanton" standard requires the provider to know that what they were doing was almost certain to lead to injury.¹²⁷

ROLE AND RESPONSIBILITY OF EXPERT WITNESSES IN EMERGENCY MEDICINE

In a malpractice lawsuit, the plaintiff must prove that the physician has violated the standard of care and was therefore negligent. In most jurisdictions, expert witnesses are brought into court to state their "expert" opinion of the care given and if it violated the standard of care.¹²⁹ The rules about who can provide expert witness testimony vary widely, with some jurisdictions requiring that the expert be of the same specialty as the defendant and others requiring only that the expert be a licensed physician without regard to specialty.¹³⁰ The quality of some expert testimony has become a concern of specialty societies, and some societies have begun to call for action against or attempt to sanction members providing misleading or inaccurate testimony.^131,132 The American College of Emergency Physicians has released guidelines for its members when acting as expert witnesses including the belief that expert testimony constitutes the practice of medicine.¹³³ These guidelines include the expectations that: (1) "the expert witness should review the medical facts in a thorough, fair, and objective manner and should not exclude any relevant information to create a view favoring either the plaintiff or the defendant"; (2) "the expert witness should not provide expert medical testimony that is false, misleading, or without medical foundation"; (3) the expert "be in the active clinical practice of emergency medicine for three years immediately preceding the date of the event giving rise to the case"; (4) the expert is willing to allow their testimony to be submitted to peer review; and (5) "misconduct as an expert, including the provision of false, fraudulent, or misleading testimony, may expose the physician to disciplinary action."^133,134 Emergency physicians acting as expert witnesses should be aware of these guidelines and strive to provide testimony that is a credit to themselves, the legal process, and the specialty of emergency medicine.

Other areas of ED practice with legal implications are listed in Table 303-9. The legal risk varies from state to state, and clearly written guidelines, an understanding of local laws, and an honest approach that avoids any appearance of conflict of interest can minimize risk.

This chapter does not address state-specific issues or replace the advice of the hospital attorney in a given situation. The information provided in this chapter is not intended to be legal advice. Laws and regulations are always changing, and this chapter does not replace a timely consultation with an attorney specialized in healthcare issues.