141: Risk Management and Legal Principles

The number and diversity of toxicologic emergencies faced by emergency department (ED) staff have increased steadily since the early 1970s and continue to rise today. This chapter discusses the medical–legal management of patients who are exposed to xenobiotics that may alter their ability to think. It also addresses the legal and ethical dilemmas routinely encountered by emergency medicine practitioners.

Patients with toxicologic emergencies require immediate care, and yet are often unable to give consent because their impaired consciousness prevents them from making informed decisions. Treating patients who present with an acute organic impairment manifested by confusion, irrational thought, or even dangerous behavior is very challenging. Emergency practitioners must recognize the medical–legal problems created when the impaired patient refuses treatment and insists on leaving against medical advice. The issue is further complicated by the variations in relevant state laws. Emergency practitioners must become familiar with the legal requirements of informed consent and the essential management necessary to avoid liability for negligence and abandonment within the state that they practice. Of particular concern are the risk management and liability issues that relate to impaired patients attempting to leave the ED before medical care is complete. The legal requirements of informed consent in emergency settings, the duty to treat, medical malpractice, battery, and negligence, are examined here. Guidelines based on generally accepted common law principles are suggested for developing appropriate patient care plans and departmental policies. These issues and principles are best illustrated by case examples.

Patient 1

An 18 year-old college student was brought by ambulance to the ED after a friend reported seeing her in the bathroom with slit wrists and an empty bottle of acetaminophen (APAP). In the ED, the patient was alert and oriented to person, place, and time. Vital signs were: blood pressure, 120/65 mm Hg; pulse, 95 beats/min; respiratory rate, 16 breaths/min; and temperature, 99.1°F (37.3°C). A rapid bedside glucose concentration was 120 mg/dL. The patient stated that she ingested the APAP approximately 5 hours earlier. The health care team wished to measure an APAP concentration to determine whether N-acetylcysteine should be administered. The patient refused venipuncture and stated that she would refuse any medications. The physicians informed the patient that she might suffer irreparable damage to her liver and possibly die if not treated immediately.

Medically treating patients against their will poses a difficult problem. Forcible treatment violates a patient’s autonomy and their right to privacy. However, harm may be caused to the patient if the appropriate evaluation and treatment is not performed. As an example, in the case above, the patient gives a history of ingesting a large amount of APAP, which may cause hepatotoxicity and even death if not treated (Chap. 35). Her refusal for this evaluation highlights the important issue of whether a physician is ever justified in performing an assessment of someone who is alert and oriented, yet poisoned, and who refuses treatment. Do most patients suffering from a mental illness such as depression need to be treated against their will? If the harm that faces the patient is not immediate, but certain in the near future, does the physician have the authority to treat? General principles of patient autonomy and informed consent will be elucidated here.

A patient’s right to choose the course of medical treatment was first recognized in the early twentieth century in a landmark case decided by the New York State (NYS) Court of Appeals in Schloendorff v Society of New York Hospital.²⁴ Mary Schloendorff was admitted for abdominal pain and was found to have a mass on physical examination. Her physicians offered her a more thorough examination under anesthesia and the option for surgery. Although she consented only to the exploratory surgery, during the procedure the mass was removed. Postoperatively, Schloendorff developed an infection and gangrene, and several fingers were amputated. She sued the hospital. In its decision, the Court upheld Schloendorff’s right to self-determination, and the right to refuse treatment. It stated:

This decision became the foundation for the “Doctrine of Informed Consent.” Informed consent serves to protect a patient’s autonomy, and creates the concept that each individual has the right to choose a personal course of medical treatment.³⁶ This includes the right to refuse care, and the right to terminate care already in process. In a nonemergent situation, it is the responsibility of the physician to obtain approval from the patient or surrogate before rendering treatment.

Generally accepted components to the informed consent process consist of (1) an explanation of the treatment or procedure, (2) alternative choices to the proposed intervention, and (3) relevant risks, benefits, and uncertainties associated with each alternative. This discussion must take place whether the patient is consenting to a procedure, or refusing a recommended procedure. A patient does not automatically assume the risks of rejecting the recommendations of the physician if the patient has not been fully apprised of the consequences of his or her decision.²⁹ Furthermore, it is the duty of the physician to assess how well the patient understands the above information. Before a physician may accept a patient’s approval or refusal of care, the patient must demonstrate adequate understanding of the information discussed.

State courts may apply one of two standards to determine if the information communicated by the physician was sufficient. The reasonable person standard requires a physician to disclose information that a reasonable person in the same position as the patient would need to make an informed decision.¹⁰ The alternative is the reasonable physician standard, which requires a physician to reveal information that a reasonable physician in a similar circumstance would disclose.¹⁰ States vary on which standard they apply.

Courts recognize that the requirement for informed consent is not absolute, and that there are exceptions in which a physician does not need to obtain permission before rendering treatment. In Schloendorff v. Society of New York Hospital, the Court recognized that consent is not required in emergency situations. Situations are generally considered emergent if care of the patient would be compromised if there were a delay in treatment. In New York, an emergency is defined as a situation that includes both the immediate endangerment of life or health and the need for the immediate alleviation of pain.²⁷ Physicians need to determine the specific requirements of informed consent in their respective states.

Often well-intended efforts of the physician to communicate treatment information to an impaired patient prove ineffectual and present the practitioner with a medical–legal dilemma. The physician may be unable to discuss in a meaningful way the implications of the proposed treatment with the patient. Nevertheless, there is a duty to treat the patient who presents with a life-threatening condition or the potential for permanent disability. In these situations, consent is considered to be implied, and emergent treatment should be provided. The principle of implied consent is a general tenet of tort law.²¹

Patient 2

A 28 year-old woman was brought to the ED by police who believed she might be a “body stuffer” (an individual who swallows drugs to avoid arrest and prosecution). The triage nurse helped the patient onto a stretcher and brought her to the treatment area and recorded normal vital signs. The patient became combative and uncooperative as the physician initiated the examination and he verbally ordered that the patient be restrained. The patient was given 40% oxygen via face mask, cardiac monitoring was begun, and an intravenous line was started with 0.9% sodium chloride at 125 mL/h, then a bolus of 100 mL of D₅₀W and 100 mg of thiamine were administered intravenously (IV). Orogastric lavage was then performed, and 50 g of activated charcoal (AC) was administered.

One hour after arrival the patient’s vital signs were: blood pressure, 120/70 mm Hg; pulse, 82 beats/min; and respiratory, rate 24 breaths/min. The patient was noted to be stable and transferred to an observation unit. Oxygen and cardiac monitoring were discontinued. No further orders were: written, and the patient remained restrained. Three hours later the vital signs were: blood pressure, 110/60 mm Hg; pulse, 92 beats/min; and respiratory rate, 18 breaths/min. A nursing note stated the patient was resting comfortably.

Forty-five minutes later, the initial physician completed his shift at midnight and informed his replacement that the patient was stable and resting in the holding area.

At 4:20 am the patient was found unresponsive and hypotensive, with agonal respirations and a weakly palpable pulse. She felt very hot to the touch and had a rectal temperature of 108°F (42.4°C). Resuscitative efforts were initiated but were unsuccessful. Thirty minutes later the patient was pronounced dead.

Several important risk management questions frequently arise in medical malpractice litigation involving the ED. To prove that a case constitutes medical malpractice, a plaintiff’s attorney must show clear and convincing evidence of a departure from good practice by the physician. The attorney must further demonstrate that the negligent act or omission by the physician proximately caused the patient’s injury. Courts have held that where “there is substantial probability that the [defendant physician’s] negligent conduct caused the resulting injury, that sufficient evidence has been developed against [the] physician.”³⁵

The problems associated with an improperly documented ED record are numerous, but they can be minimized if the practitioner is cognizant of risk management principles. When the attorney for the patient (plaintiff’s attorney) introduces evidence to prove the case, the central document in the medical malpractice trial is likely to be the ED record. Thus, every entry in that record is scrutinized with great care by both parties (plaintiff and defendants), and the importance of completing it with knowledge of risk management implications should be a concern for all health care professionals.

The physician is required to write a medical record that will amply support the basis for the medical judgments exercised. When a physician chooses to write only a summary statement on the record without noting supporting clinical data or patient history, claims alleging failure to diagnose will be extremely difficult, if not impossible, to defend. One of the basic elements of the defense in a medical malpractice case is that the physician’s judgment was appropriate, given the clinical facts and the patient’s history available at that time. Therefore, physicians who do not record supporting clinical data and history deprive themselves of a strong “medical judgment” defense.

Inappropriate entries or markings on the medical record can weaken the defense in a liability case. For example, in attempting to correct an error in entering a PO₂ value, if the physician or nurse totally obliterates the number, an attorney representing a patient may suggest to the jury that the obliteration was done intentionally to conceal clinical data harmful to the position of the defense. If a physician must correct a prior entry made on the record, then the preferable method is to draw a single line through the value or word to be changed, insert the correct information directly above, and initial the correction. Timing and dating the correction also precludes potentially difficult questions of chronology and responsibility in a courtroom setting. By following these suggestions, the physician can avoid any accusations of intentionally concealing an error in judgment (Fig. 141–1).

A frequent claim is that the patient was abandoned or improperly monitored. For the above patient, although the chart appears to document repeated vital signs at appropriate intervals, no temperature is included after the first set until the patient is moribund, nor is any mention made again of the continued use of restraints, the continued need for these restraints, or any adverse effects developing from the use of restraints. Additionally, documentation of physician assessment of the patient’s medical condition is incomplete. For example, there is no mention in the physician’s notes of the possible cause of the patient’s change in mental status. Likewise, there is no documentation regarding the police officers’ concerns that the patient was a “body stuffer.” Body stuffers quickly ingest a drug to avoid detection, which can result in life-threatening toxicity (SC 5). Documentation of the physician’s review of this concern is necessary.

Quality assurance reviews of ED records often demonstrate inadequate charting by physicians and nurses monitoring patients who remain in the department for prolonged periods of time. Under any circumstances, a lapse of documentation of the patient’s clinical condition for 4 hours or more after the initial physician and nursing assessment creates a potential risk management problem. In a lawsuit, the plaintiff’s attorney would undoubtedly use such a record to develop the theory that no care whatsoever was given to the patient during this time interval, and that the patient was abandoned.

Monitoring notations in the medical record are considered inadequate when they do not offer insight into the patient’s clinical status. Thus, any monitoring note for a patient who must be restrained in the ED for a lengthy period of evaluation, observation, or until an inpatient bed becomes available must include specific clinical data and observations (laboratory results, radiographic findings, hemodynamic changes, and infusion of medications and solutions). All of these deficiencies would undoubtedly be noticed and highlighted at trial by a plaintiff’s expert, who frequently is a board-certified physician in the same specialty.

Documentation supporting the restraint of an impaired patient against his or her will must include a clinical description to support such a forcible impediment to the patient’s right to liberty and freedom of movement. Such a clinical description should specifically describe any manifestation of agitation and uncooperative behavior. The record should refer to the specific uncooperative acts of the patient and, most importantly, should comment on the difficulties in providing care to the patient because of the patient’s actions.

Physicians who order restraints for patients must exercise extreme caution in the language used to describe such patients. A judgmental note stating that a patient is “a chronic drunk and obnoxious” could undermine the support for the use of restraints. Poorly written notes can become an issue in a medical malpractice action, with the plaintiff’s attorney focusing on the derogatory nature of such a statement and suggesting a less than caring attitude by the doctor toward the patient. A plaintiff’s appeal that criticizes the ethical and social consciousness of the physician could very likely be seized upon by a jury, resulting in a punitive verdict against the physician. As a general rule, all health care professionals should depict a compassionate and professional manner when describing patient behavior and lifestyles in objective and concrete terms. An alternative and more appropriate description of a patient comparable with the one above would note that the patient had a “history of alcohol dependence and was agitated and or combative.”

To summarize, a well documented ED record consistent with the accepted risk management principles set forth is the best course for the physician managing a difficult overdose situation in which legal principles may appear to present problems in providing proper medical management.

Patient 3

A 31 year-old woman was found unresponsive on the street and brought to the ED by ambulance. Friends on the scene reported that the patient used methadone. In the ED she was unresponsive and apneic. Oxygen was immediately administered by bag-valve mask and intravenous access was obtained. Naloxone was administered, and shortly thereafter the patient regained consciousness. After 20 minutes of care in the ED, the patient became fully alert and oriented, with no evidence of hypoxia or other clinical signs to suggest impaired judgment. The patient stated that she had taken methadone and demanded to be discharged immediately.

The right of a hospital to retain and physically restrain a person who has an altered level of consciousness for evaluation and emergency intervention is generally well supported by states and case law.¹¹ Reasonably clear guidelines for the management of such impaired patients have evolved from legal precedents governing appropriate medical assessment, from risk management considerations, and from the predictability of patient injury in the event of premature discharge.

A staff decision to allow a treated or partially treated patient with a drug overdose who subsequently becomes alert to return to the community must be based on an assessment of several factors. The initial concern is the capacity of the patient to comprehend. Before the patient can be permitted to leave the hospital, a determination would have to be made that the patient is capable of understanding the information presented and has neither a medical nor a psychiatric problem preventing such a voluntary decision. The next consideration is that of medical stability. Has the initial process that caused the clinical scenario completed its course? The history of drug use in this patient is cause for concern that the underlying toxic metabolic process is not yet resolved, and alteration in mental status, significant respiratory compromise, or other medical symptoms may recur when the naloxone is metabolized, again placing the patient at risk.

Common ED practice and sound legal principles suggest that both the hospital and its staff have a duty to prevent such a person from leaving if the duration of the effect of the involved xenobiotic is longer than that expected for the antidote. Because the duration of effect for naloxone is considerably shorter than that of methadone, the physician can predict with reasonable certainty that coma or apnea will reoccur in the near future. The physician has the duty to inform the individual of the life-threatening nature of the condition, and then to retain, with restraints if necessary to retain, the patient in the hospital until medically stable.

Liability in this situation is further reduced when the chart substantiates the medical judgment that was the basis for the decision to retain the patient and, if applicable, the use of restraints. Such documentation should specifically note the likely relapse of the patient into a symptomatic state and that this occurrence could place the patient in a life-threatening situation. When documented in a clear manner, legal challenges to the decision to restrain the patient have a limited chance of success. Sound risk management principles support treatment and detainment. Conversely, prematurely releasing a patient with a significant overdose exposes both the physician and the hospital to a claim of negligence on the grounds of failure to foresee a likely and harmful event.

Patient 4

A 41 year-old man who was a driver involved in a motor vehicle collision was taken to the ED by ambulance. Two motorists in another vehicle were killed. The patient had no physical complaints, but was brought to the hospital for medical clearance. On arrival, he was alert and oriented, responded appropriately to all commands, and demonstrated normal motor function and had a normal gait. Police officers suspected that he was driving while intoxicated, but he refused a breath alcohol test at the scene.

The police officers informed the ED staff that he was arrested and might be charged with vehicular homicide. The officers then requested that the emergency physician draw a blood specimen to determine the blood alcohol concentration. The patient stated that he would not allow the ED staff to draw blood for a determination of an alcohol concentration.

In 2010, there were 10,228 people who died in alcohol-related motor vehicle crashes, which was 31% of all traffic related deaths in the United States.⁹ This number has declined in recent years and has decreased 4.9% from 2009. In the United States, an alcohol-related motor vehicle crash kills someone every 51 minutes.⁹ In 2010, crashes resulting from alcohol-induced impairment were responsible for 17% of fatalities in children younger than 14 years who were killed in motor vehicle crashes.⁹ Alcohol-impaired motor vehicle crashes cost more than $37 billion every year.⁸ Drugs other than alcohol (eg, marijuana and cocaine) are involved in about 18% of motor vehicle driver fatalities.¹⁵ The judicial system has historically been one of the most effective tools to combat drunk driving, and its effectiveness depends on the ability to identify and punish individuals who violate the law. It is essential, however, that the collection of evidence does not violate the rights afforded by the US Constitution. Does forced phlebotomy for patients suspected of driving while intoxicated violate these protected rights? This has long been debated in the courts, and issues specifically brought into question include the Fourth Amendment,³⁰ the right against unreasonable search and seizure; the Fifth Amendment,³¹ the right against self-incrimination, and the Due Process clause of the Fourteenth Amendment.³² Past decisions on these issues help guide current laws and practices.

Every state, and the District of Columbia, has driver “implied consent” laws. When a person obtains a driver’s license, he or she consents at the time of acquisition to a chemical alcohol test if suspected of driving while intoxicated. Under implied consent laws, when a person suspected of driving while intoxicated refuses to take an alcohol test, a penalty is imposed. Specific penalties for refusals vary from state to state. At a minimum, the refusal results in suspension or revocation of a driver’s license. Some states assign additional fines and penalties for this action. A few states allow the refusal itself to be submitted at trial in support of the prosecution, making it possible to be convicted of an intoxication charge without chemical evidence.³ Certain states (eg, Texas, Illinois) allow blood tests to be performed on patients as ordered by an officer of the law, when there is probable cause of driving while intoxicated resulting in severe injury.^20,28 Other states, such as New York and California, allow forced blood samples with a warrant issued by a judge.^5,18 State laws regarding the approach to this situation vary and it is important that the ED staff be familiar with the specific requirements of the law of that state.

How much force may be used to collect chemical evidence? Does a physician violate human dignity and privacy in obtaining evidence for the State? These issues were addressed by the United States Supreme Court. In Rochin v California,²³ the Court overturned a conviction of drug possession based on violation of the Fourteenth Amendment. In this case, police were informed that Rochin was selling drugs. While entering the home of the defendant, the police witnessed the defendant swallow two pills that were lying on the night stand. When the officers failed to recover the pills on the scene, the officers took Rochin to the ED, where they directed the physician to administer an emetic through a nasogastric tube. The capsules were recovered from the vomit, and Rochin was convicted by the trial court for possessing morphine.^1,23 The Supreme Court reversed this decision, based on the Fourteenth Amendment, “nor shall any State deprive any person of life, liberty or property, without due process of law....”³⁶ The term due process is vague, and is defined on a case-by-case basis, but it essentially means that states must use fair legal procedures when depriving an individual of life, liberty, or property. In Rochin, the court concluded that forced emesis by a physician was believed to violate Due Process, stating:

The Supreme Court revisited the issues presented in Rochin 4 years later in Breithaupt v Abram.⁴ Breithaupt was the driver of a truck who killed three occupants of another vehicle. In the ED, a police officer requested that a blood alcohol concentration be drawn. The blood, drawn while the patient was unconscious, was above the legal limit for alcohol and the patient was convicted of involuntary manslaughter. Breithaupt argued that the blood draw, as in forced emesis in Rochin, violated due process as he did not consent to its collection. Justice Clark disagreed, stating “the distinction rests on the fact that there is nothing ‘brutal’ or ‘offensive’ when done, as in this case, under the protective eye of a physician” and that the “blood test procedure has become routine in our everyday life.”^3,4 Phlebotomy while the patient is unconscious and unable to give consent was determined not to violate the due process clause of the Fourteenth Amendment.

The Supreme Court continued to expand the scope of permissible phlebotomy in Schmerber v California.²⁵ Schmerber was involved in a motor vehicle crash in which the police officer suspected he was intoxicated. Unlike in Breithaupt, Schmerber was conscious, and a physician drew a blood sample at the officer’s request despite the patient’s verbal refusal. The attorney for Schmerber asserted that forced phlebotomy violated several constitutional rights. Specifically, it violated the Fourth, Fifth, and Fourteenth Amendments of the US Constitution. He alleged that forced phlebotomy denied him due process of the law, it violated his privilege against self-incrimination, and it violated his right against unreasonable search and seizure.^3,25

The Supreme Court rejected all of these arguments. The phlebotomy did not violate the due process clause because “the extraction was made by a physician in a simple, medically acceptable manner in a hospital environment . . We cannot see that it should make any difference whether one states unequivocally that he objects or resorts to physical violence in protest or is in such condition that he is unable to protest.”²⁵ Furthermore, the forced blood draw did not violate the Fifth Amendment’s Privilege Against Self-Incrimination because the Fifth Amendment only protects evidence of a “testimonial or communicative nature,” such as writings or speech. Finally, there was no violation of the Fourth and Fourteenth Amendments’ protections against unreasonable search and seizure as the delay necessary to obtain a warrant threatened the destruction of evidence. Considering the “totality of the circumstances” in Schmerber, the blood alcohol test fell under the Court’s exigent circumstances exception to the general requirement of a warrant.

The percentage of alcohol in the blood begins to diminish shortly after drinking stops, as the body functions to eliminate it from the system. Particularly in a case such as this, where time had to be taken to bring the accused to a hospital and to investigate the scene of the accident, there was no time to seek out a magistrate and secure a warrant.

To ensure compliance with standards set forth in Schmerber, the states have tailored laws and regulations governing the seizure of blood for the purpose of blood alcohol testing. Laws generally require the procedure be (1) performed in a reasonable, medically approved manner, (2) incident to a lawful arrest, and (3) based on the belief that the arrestee is intoxicated. It should be remembered that the issues raised by any one case are complex, and the application in real situations is difficult. Laws and regulations governing blood draws for alcohol testing vary from state to state and are the subject of frequent restructuring and amendment. Medical staff should review with hospital counsel the local laws and regulations that pertain to these issues. However, physician and patient safety must always be the priority. The benefits of determining a patient’s blood alcohol concentration must be weighed against the risks of the procedure. For example, drawing blood in an agitated patient may place the staff at risk for a needle stick and the patient at risk of vascular injury.

It should also be noted that the US Supreme Court in Missouri v. McNeely restricted the holding of Schmerber for warrantless blood alcohol testing.¹⁷ In McNeely, the State of Missouri argued that the metabolism of alcohol over time, by itself, was justification to obtain warrantless blood alcohol testing in the hospital. The US Supreme Court rejected this argument. While the dissipation of alcohol from the blood stream over time is one of the factors to consider when evaluating the “totality of the circumstances,” it does not meet the exigency exception to the warrant requirement by itself. The majority opinion held that “when officers in drunk driving investigations can reasonably obtain a warrant before having a blood sample drawn without significantly undermining the efficacy of the search, the Fourth Amendment mandates that they do so.” This does not suggest that a physician should insist on a warrant when an officer requests a blood alcohol test, as this is a protection that is afforded retrospectively by the courts. Familiarity with local regulations is necessary to properly manage requests for blood alcohol testing.

Patient 5

A 32 year-old woman was fired from her job as a high school mathematics teacher. The school board called for her termination after learning that she had a history of alcohol dependence and had a previous hospitalization for detoxification at the local community hospital. A parent on the school board was also employed as a nurse at the hospital, where the teacher had received therapy. The school board member (and nurse) had inadvertently accessed the medical record of the teacher while caring for a patient with the same last name.

The Health Insurance Portability and Accountability Act (HIPAA) was enacted by Congress in 1996 and signed by President Clinton. Initially, the purpose of HIPAA was to increase the portability of health insurance, and allow employees to maintain insurance when they changed jobs. The Act called for the establishment of several provisions, among them an electronic database designed to facilitate the exchange of information between health care professionals, insurance companies, and those involved in financial and administrative transactions.¹⁶ However, the idea of developing an electronic database brought to light already growing concerns regarding the maintenance of patient privacy. For the first time, medical records would be accessible to an unlimited number of people working in health care, from bill processors to pharmacists to clinicians. Could the right to privacy be jeopardized by a system designed to increase efficiency?

Prior to HIPAA, individual hospitals or physician offices designed their own methods for maintaining confidential patient information. Records were maintained on computers in some circumstances and on paper in others. Accessibility to that information was largely regulated by state laws, and supported by some federal regulations and ethical codes of conduct. During the 1990s, however, the weaknesses of the existing systems gained attention as multiple high profile breeches of confidentiality surfaced. For example, the medical records of a congresswoman were released to the media during her campaign, making her history of depression and a past suicide attempt public knowledge.²⁶ There were also several cases of the medical records of hospital employees being read by staff members not involved in the employees’ care, health insurance companies releasing health care information to employers without permission, and physicians releasing information to pharmaceutical companies that subsequently solicited the patient.³⁷ These breaches of ethics were each a testament to the fact that the right to privacy needed more stringent regulation. If these examples could occur in the previous systems for recording information, then it could be assumed that further violations would occur with increased access through an electronic database.

The Privacy Rule of HIPAA has become the most well-publicized aspect of this Act among health care personnel. The Privacy Rule governs the use and disclosure of protected health information in the hands of health care professionals, health plans, and health care clearinghouses.¹⁶ The terminology used in the Privacy Rule is extensively defined. The following is a brief summary of the terms used.

Protected Health Information

Protected health information includes any individually identifiable information concerning the past, present, or future health of an individual; medical information pertaining to assessment and treatment of an individual; in addition to payment and billing information. All forms of information, written, oral, or electronic, are protected by this rule. Deidentified data are not considered protected health information.

Covered Entities

The term “covered entities” includes any person or business that provides health-related services or products. All those providing health-related services, for example, clinicians, pharmacists, medical equipment providers, and other health care professionals, are considered covered entities. Companies that provide disability insurance, car insurance, or casualty insurance are not included in the rule.^16,33

Health Care Clearinghouses

Health care clearninghouses are entities that compile health care information, such as billing companies or data processing centers.

Institutions are required to provide all individuals with written notice of their privacy policy when they first seek medical care. Patients must be informed of how the institution may use and disclose information. The notice must also describe patients’ rights, including the right to access their medical information and their right to file a complaint if they believe their rights are violated. The notice must be written in plain language, and the patient must be written acknowledgment of receipt of the information in the notice.

The Privacy Rule of HIPAA was not intended to impede health care. There are several exceptions to the rule. A covered entity is permitted to use and disclose protected health information for the purposes of evaluation and treatment. Physicians have the freedom to consult with each other, both within and outside their own institution in order to provide clinical care. Additionally, there are several specific exceptions to the Privacy Rule listed within the document—situations in which protected health information may and often must be disclosed, and may be done without an individual’s permission. For example, activities related to public health, such as reporting communicable diseases, information necessary to report actual or suspected abuse, neglect or domestic violence, or information pertaining to cadaver organ or tissue donation are specifically exempt from the Privacy Rule.¹²

The HIPAA Privacy Rule specifically addresses consultations with poison centers. It states: We consider the counseling and follow-up consultations provided by poison control centers with individual providers regarding patient outcomes to be treatment. Therefore, poison control centers and other health care professionals can share protected health information about the treatment of an individual without a business associate contract.¹²

Violations of the Privacy Rule are subject to penalties, the severity of which is dependent on the type of infraction. Simple noncompliance may result in financial penalties. Moreover, significant or intentional disclosures of information may incur steeper fines in addition to criminal charges and potential imprisonment.³⁷ In 2009, as part of the economic stimulus, the Health Information Technology for Economic and Clinical Health Act (HITECH) under the American Recovery and Reinvestment Act (ARRA) was passed.²² This Act was primarily created to encourage the use of electronic health records and supporting technology. However, it also widened the scope of privacy and security protections defined by HIPAA. Several notable changes are the increase in civil penalties for willful neglect extending up to $250,000 for a single violation, and as high as $1.5 million for repeated or uncorrected violations. Furthermore, HIPAA provisions now apply to business associates. Business associates are defined as persons who, on behalf of a covered entity, perform or assist in performing a function or activity that involves the use or disclosure of individually identifiable health information.

Patient 6

The Poison Center received a call from a concerned mother that her daughter might have ingested one of the grandmother’s diabetes medications. The mother stated that the child was acting normally all day at the grandmothers’ house, but when the family returned home, the child had become drowsy. When contacted, the grandmother had confirmed that one pill was missing from her purse although she did not know the name of her medication. The poison center advised that the parents give the child juice and closely observe her for the next 6 hours. Approximately 2 hours later, while sleeping, the child had a seizure. The child continued to seize in the hospital, where medical evaluation revealed hypoglycemia. The patient subsequently suffered permanent neurologic damage. The medication was later identified as glyburide. Action was brought against the poison center, alleging inappropriate advice and failure to recommend transport to a hospital.

As a general rule, any physician who decides to treat a patient enters into a physician–patient relationship that creates well established legal duties. Courts have ruled that the physician–patient encounter need not be a face-to-face interaction to have legal consequences. For example, the absence of physical contact between a physician and patient as in the practice of radiology and pathology does not preclude a patient from asserting that a duty of care exists.⁶ More particularly and quite relevant to the practice of a poison center, a New York State court ruled that an initial telephone call from a patient to a physician can be sufficient basis to hold that physician responsible for inappropriate advice or a significant error in judgment.¹⁹ Given the legal precedents previously stated, it is eminently clear that contact with a poison information specialist is a sufficient foundation for a subsequent legal action if inappropriate advice was given.

Standards of care applicable to toxicologists are examined under the same legal framework as other medical specialists. The basic medical malpractice concepts are universal with some variations from state to state. Generally, for patients to prevail in medical malpractice cases, they must demonstrate “by a preponderance of the evidence: (1) that the doctor’s treatment fell below the ordinary standard of care expected of a physician in his [or her] medical specialty, and (2) the existence of a causal relationship between the alleged negligent treatment and the injury sustained.”³² While standard of care is recognized not to be one of perfection, what constitutes the “ordinary standard of care” has much room for interpretation.

In the nineteenth century, courts determined what the “ordinary standard of care” was by introducing testimony from physicians practicing in the community where the event occurred. This was known as the strict locality rule.³⁴ The strict locality rule was intended to prevent the inequities of comparing rural physicians working with limited resources and under exigent conditions from physicians working in large urban hospital settings.¹⁴ In many jurisdictions, however, the strict locality rule was rejected because (1) it was difficult to find an expert witness in a small community to testify against another physician in the community, and (2) the strict locality rule permitted some small medical communities to set unacceptably low standards of care.³⁴ In response, some states adopted the modified locality rule, which compares the physician in question with physicians practicing “in similar localities.”³⁴ Over time, the basis for the modified locality rule was also questioned. Advances in transportation, communication, and education continued to minimize the disparity between rural and urban medical practice. Many states abandoned the locality rule altogether, permitting evidence of nationwide medical practices, as described by one court:

While there is movement toward reviewing nationwide medical practices, depending on the jurisdiction where the event occurs, any one of the above rules may apply. In New York, courts allow evidence from the specific locality where the event occurred, from statewide practice, or from nationwide practice.¹³

A discussion of standard of care for poison control specialists should also mention several operational aspects of poison centers. Poison information specialists are required to have rapid and accurate access to a standard information resource system that contains both basic information and recommendations to deal with most toxic exposures. If a patient were to bring an action, then the negligence theory against the poison center might rely on deviations from the standard recommendations in these resources.

It would be inaccurate to suggest, however, that the duty of care owed by a poison information specialist can be measured only by how closely the advice given compares with these standard resources. Frequently, a poison specialist may encounter situations that cannot be managed in accordance with an information system alone, and may seek counsel from a clinical pharmacist or a medical toxicologist working with the poison center. If this were to occur, then any subsequent legal proceeding would also review carefully the content of the information given to the consultant regarding accuracy and appropriateness of treatment for the underlying toxicologic problem.

A comprehensive review of state-enacted legislation providing additional liability protection to poison center consultants is outlined elsewhere.⁷ These state statutes provide either immunity from malpractice claims or indemnity for a successful claim against a poison center consultant. The statutes are state specific and poison center consultants should review them with local counsel, particularly if the statute has not been challenged in the jurisdiction in question.

Several states have enacted laws granting immunity to poison center consultants. Immunity is an affirmative defense to medical malpractice liability. In other words, even if a lawsuit were to meet all of the criteria for a successful malpractice claim, the lawsuit would not lead to compensation for injuries sustained because of this state-conferred protection. Examples of states that have enacted statutes providing immunity include Arkansas, California, Florida, Louisiana, Ohio, Tennessee, and Washington.¹ These statutes are not absolute protections from liability. State statutes granting immunity usually stipulate that the poison center consultant act in good faith while performing the duties required. In some instances, the poison center consultant must have been providing information in accordance with protocols established by the poison center. These laws do not protect against gross negligence, nor do they provide protection against intentional misconduct by the poison center consultant.

Other states have enacted laws that require the state to indemnify poison center consultants in the case of a successful malpractice claim. In other words, a patient may bring a medical malpractice claim against a poison center consultant, but if the claim is successful, the state itself compensates the patient rather than the poison center consultant. States that have enacted indemnity statutes, including Illinois and Texas.³⁹ Statutes providing state indemnification for medical malpractice claims are also limited in that they do not provide protection in the case of gross negligence, nor do they provide indemnity in the case of intentional misconduct.

In addition to state statutes that specifically limit liability for poison center consultants, it has been argued that some states may hypothetically provide protections under common law or general “public immunity” statutes.³⁸ Neither poison centers nor poison center consultants are specifically named under these state laws, but may be afforded immunity protection. States with general common law or “public immunity” statutes include North Carolina, Missouri, Illinois, Connecticut, and Georgia. Finally, many states have sovereign immunity statutes that afford liability protection to any entity created, funded, and operated by the state. Poison centers and their staff may be considered such an entity, and therefore, granted the protection.

There are some inherent risks of potential liability for a poison center. To minimize such risk and the risk of civil actions against a poison center, quality assurance and risk management programs should be a regular function. Daily audits or monitoring of the advice given by poison information specialists should be done. Such interactions enhance care and ensure patient safety for the individual and establish a higher general standard.

The medical toxicologists and clinical pharmacists responsible for supervising the poison information specialists must be able to adequately assess the competence and capabilities of the staff and to make recommendations, take corrective actions, and provide suggestions for improvement to involved members. This process is facilitated by such actions as audiotaping calls made to the poison center and the subsequent advice given, and reviewing written records maintained by the information specialist on each particular case. Documentation is extremely important, because in the event of a lawsuit, the most likely area of dispute will be what was actually said to the patient.

• The risk management and legal issues of an ED with patients exposed to xenobiotics, often with impaired judgment, are complex. The substantial ­practical challenges in administering emergent treatment to an individual unable to provide proper informed consent may vary depending on individual state laws with respect to initiating that treatment.

• Medical care is further complicated by the difficulties inherent in documenting these interactions with our patients.

• Furthermore, both forcible restraint (often desired by the physician) and evidence collection (requested by law enforcement) have significant potential ramifications for the care provider.

• Maintaining patient confidentiality outside the ED, despite circumstances often visibly volatile within, may seem futile, yet legal obligations to protect patient privacy have become more stringent, not less.

• A well organized hospital is dependent on a close working relationship among the legal, risk management, and medical personnel. Only in this manner can they learn, cooperate, and meet the needs of the ever-evolving clinical dilemmas they confront.

Acknowledgments

Walter LeStrange, RN, MPH, MS, and Kevin Porter, Esq, contributed to this chapter in previous editions.

References