Legal and Ethical Aspects of Pediatric Emergency Medicine

Carmen M. Lebrón MD FAAP

Emergency Department

San Jorge Children’s Hospital

San Juan, Puerto Rico

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We will discuss…

Informed consent in the emergency department Malpractice EMTALA

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Consent

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Consent

Informed consent for medical care is a basic requirement that should be met from the outset of almost all physician-patient relationships

Potential legal and ethical conflicts arise when the patient is a minor• minors are not legally permitted to give consent

for their own care based on their level emotional maturity and cognitive development

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Some definitions

Minor• An individual under the age of majority

Defined as age 18 in all but 4 states¹ AND Puerto Rico

In PR legal age of majority is 21 as defined by the civil code– Adopted by the Department of Health– NOT by the Department of Family and Child

Services» Legal age of majority for them is 18

1.Boonstra H, Nash E. Minors and the right to consent to health care. Guttmacher Rep Public Policy 2000;3:4–8

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1991 study in Michigan documented that approximately 3% of the visits by minors to emergency departments were unaccompanied¹

More recently, this number has been estimated to be even higher by the American Academy of Pediatrics, Committee on Pediatric Emergency Medicine

1.Treloar DJ, Peterson E, Randall J, et al. Use of emergency services by unaccompanied minors. Ann Emerg Med 1991;20:297–301.

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Adolescents in particular are considered relatively disenfranchised from the health care system, more often uninsured, and without a consistent source of primary care

Adolescents account for 10% to 15% of all pediatric emergency department visits and greater than 5% of adult emergency department visits ¹

1. Ziv A, Boulet JR, Slap GB. Emergency department utilization by adolescents in the United States. Pediatrics 1998;101:987–94

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An analysis of the 1997 Commonwealth Fund Survey of the Health of Adolescent Girls found that 4.6% of adolescents, or 1.5 million individuals, identified the emergency department as their only source of health care¹

Wilson KM, Klein JD. Adolescents who use the emergency department as their usual source of care. Arch Pediatr Adolesc Med 2000;154:361–5

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Consent

Can prevent Emergency Department (ED) physicians from providing timely evaluation and care

It’s a legal concept that has become more complex• Consent laws vary from state to state• Times are changing

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Consent

Joint Commission on Accreditation of Healthcare Organizations (JACHO) requires a policy on consent for treatment and the rights of patients

Interpretation of this policy may cause delays• Triage• Registration

Delay • Rarely occurs when patient arrives in the ED by

ambulance

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Consent

Consent for minors is obtained through parents or legal guardians• May be given by variety of caretakers acting in

loco parentis• Presumption that those individuals would use a

‘‘best interest standard’’ Parental consent generally expected when a minor

seeks medical care• Numerous exceptions to this requirement

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Consent

Consent is considered to be implied in the emergency treatment of a minor• The criteria for defining an emergency are

neither uniform nor universal Treatment that may lessen pain or prevent

disability in the near or distant future also may be considered to fall under the realm of emergency care¹

1. American Academy of Pediatrics, Committee on Pediatric Emergency Medicine. Consent for emergency medical services for children and adolescents. Pediatrics 2003;111:703–6

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Legal Exceptions to InformedConsent Requirement

Medical Care Setting

The “emergency” exception Minor seeks emergency medical care.

The “emancipated minor” exception Minor is self-reliant or independent: • Married • In military service • Emancipated by court ruling • Financially independent and living apart from parents In some states, college students, runaways, pregnant minors, or minor mothers also may be included.

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Legal Exceptions to InformedConsent Requirement

Medical Care Setting

The “mature minor” exception Minor is capable of providing informed consent to the proposed medical orsurgical treatment—generally a minor 14 y or older who is sufficientlymature and possesses the intelligence to understand and appreciate thebenefits, risks, and alternatives of the proposed treatment and who is able tomake a voluntary and rational choice. (In determining whether the matureminor exception applies, the physician must consider the nature and degreeof risk of the proposed treatment and whether the proposed treatment is forthe minor’s benefit, is necessary or elective, and is complex.)

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Legal Exceptions to InformedConsent Requirement

Medical Care Setting

Exceptions based on specific medicalcondition

Minor seeks:• Mental health services• Pregnancy and contraceptive services• Testing or treatment for human immunodeficiency virus infection oracquired immunodeficiency syndrome• Sexually transmitted or communicable disease testing and treatment• Drug or alcohol dependency counseling and treatment• Care for crime-related injury, child abuse or neglect

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Current federal law under the Emergency Medical Treatment and Active Labor Act (EMTALA) mandates a medical screening examination (MSE) for every patient seeking treatment in an ED of any hospital that participates in programs that receive federal funding, regardless of consent or reimbursement issues¹

EMTALA preempts conflicting or inconsistent state laws, essentially rendering the problem of obtaining consent for the emergency treatment of minors a nonissue at participating hospitals

Kuther TL. Medical decision-making and minors: issues of consent and assent. Adolescence 2003;38:343–58

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Refusal of care

Competent minor/parents refusal of care can be addressed asking 3 questions:• Is the treatment necessary in the foreseeable

future? If no, may be discharged home with

appropriate, specific follow up May entail child protective services

• Is the treatment needed in the immediate future? Court orders directly from judicial official or

child protective services

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Refusal of care

• Is there immediate need for medical intervention? Consider medical condition as emergency and

treat Crucial that documentation on the medical chart

indicates assessment of • The need for consent• If indicated, determination of the parties

approached for consent• Measures taken to obtain an informed consent• Identification and resolution of conflict

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Malpractice

Medicine is a calling.Medicine is a profession. Medicine is a business.People in business get sued.

Gary N. McAbee, DO, JD

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Malpractice

Medical malpractice litigation continues to be at a crisis level in 17 states

This level has declined from a peak of 22 states designated to be in crisis by the American Medical Association and, in part, represents the effort of tort reform in some regions of the country

Doctors for Medical Liability Reform. Protect Patients Now!action center. Available at: www.protectpatientsnow.org/site/c.8oIDJLNnHIE/b.1090567/k.C061/StateInformation.htm.Accessed February 20, 2009

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Why families sue physicians

Poor outcome Poor communication, want more information Seek revenge against physician Need to obtain financial resources Wish to protect society from “bad doctor” Desire to relieve guilt Greed

Selbst, SM, Korin, JB. Preventing Malpractice Suits in Pediatric Emergency Medicine. 1999 American College of Emergency Physicians: pg 5

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Factors in malpractice actions in the emergency department

Long waiting time Long hours for staff Excessive noise Brief physician visit Impersonal atmosphere High patient volume Lack of rapport with patients

Selbst, SM, Korin, JB. Preventing Malpractice Suits in Pediatric Emergency Medicine. 1999 American College of Emergency Physicians: pg 5

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Factors in malpractice actions in the PEDIATRIC emergency department

Limited communication skills of young patients Must rely on parents for history Family members with a different set of

interpretations and concerns Difficult physical exam

• Lack of cooperation Issues of consent

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Malpractice Elements

Must have all 4 elements in order for malpractice to occur• Duty• Breech of duty• Harm• Causation

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Duty

Pretty much guaranteed in the ED Prosise vs Foster (VA 2001)

• 4 y/o w chickepox seen by intern & 3rd year resident

• No call to attending at home who was the on-call attending

• Seen the next day-diffuse varicella & pneumonia-died 1 month later

• Action suit brought against the the attending Attending found not guilty No call, no relationship established

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Breech of Duty

Standard of care• That which any reasonable physician in a

particular specialty would have given to a similar patient under similar circumstances

Amaral vs Frank (CA)• 10 y/o seen twice for LLQ pain, fever, nausea• Discharged with “viral gastroenteritis”• To OR 3 days later w ruptured appy, 2 week

admission, big scar• Plaintiff: missed diagnosis• Defense: “atypical presentation”• Judgement for the plaintiff for 75,000

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Breech of Duty

Torres Vs McBeth (CA)• Young man w 15 hrs of lower abdominal pain,

rebound, voluntary guarding, pain worse w walking. ↑ WBC increased w left shift

• Given demerol, no consult• Discharged with instructions to f/u in 8-12 hrs,

patient followed those instructions• Dx: ruptured appy• Plaintiff: missed diagnosis in a classic case• lack of care due to lack of insurance• Defendant: standard of care was applied (i.e serial

exams are the standard of care)• Defense wins.

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Harm

Peller vs Kayser (1994)• 12 y/o boy w gunshot to head near medulla• Admitted, phone conversation w neurosurgery.

Not seen by neurosurgery for 9 hrs, died shortly after.

• Plaintiff: delay in consult, denied chance of survival, no debridement or aggressive care

• Defense: fatal injury• Defense wins.

Actions did not cause harm It was inevitable outcome

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Causation

Harbuck vs TriCity ER• 12 y/o goes to ED with chin cut• TAC applied. Staff claim anxiety attack, parents

claim seizure.• Patient suffered subsequent seizures,

depression, required Dilantin over months• Plaintiff: Epilepsy and depression were result of

TAC• Defense: Properly applied TAC does not cause

seizures• Veredict for the defense

Must have causation to have negligence

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Most Prevalent Conditions in Pediatric Malpractice ClaimsCaused by Error in Diagnosis (1985–2006)

1. Meningitis 2. Appendicitis 3. Specified nonteratogenic anomalies 4. Pneumonia 5. Brain-damaged infant

McAbee, GN. Donn, SM., et al. Medical Diagnoses Commonly Associated WithPediatric Malpractice Lawsuits in the United States. Pediatrics 2008;122;e1282-e1286

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Pediatric lawsuits arising in an emergency department

1985-2000

children <2 years old • Meningitis• neurologically impaired newborns• pneumonia

children from 3 to 11 years old• Fracture• Meningitis• appendicitis

children from 12 to 17 years old• Fractures• Appendicitis• testicular torsionMcAbee, GN. Donn, SM., et al. Medical Diagnoses Commonly Associated With

Pediatric Malpractice Lawsuits in the United States. Pediatrics 2008;122;e1282-e1286

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How do we avoid malpractice suits?

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Risk Management Techniques

Listen to People• Roe v Roe(MA)• 6 y/o w CP and Developmental Delay and

recurrent status epilepticus presents to ED in status

• Mom presents a protocol for treatment prepared by the child’s neurologist calling for high dose of anticonvulsants

• ED doc ignored protocol and used standard doses

• Child continued seizing, herniated• Case settled for 750,000

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Risk Management Techniques

Be nice to people• Consider sitting for interview• Address the child when age appropriate• Acknowledge the parents’ fears

Careful how you say things!!!• “he just has a virus”• “Don’t worry he’ll be fine”• Address the specifics of the condition, expected

progression and possible complications

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Risk Management Techniques-the chart

Document all pertinent positive and negative clinical findings

Document carefully• Entries should be clear, complete, and free of

flippant, critical, or other inappropriate comments• assume that “Dear Mr/Ms Attorney” is written at

the top of the chart There are differences of opinion about how much to

write in a medical chart, but quality is always preferred over quantity

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Risk Management Techniques-the chart

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Risk Management Techniques-the chart

Communication and use of terminology is critical• Good communication involves the use of

layman’s terms and the avoidance of medical jargon

Avoid language that blames ( i.e unintentionally, inadvertently) or embellishes (i.e profound, excessive) unless it is relevant to medical care

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Risk Management Techniques-the chart

Careful and extensive documentation is critical with patients likely to sustain long-term sequelae

Read the nurses notes• Specifically address discrepancies in your note

Verbal instructions should be simple, clear, and concise.

Written material provided to patients should be written at an eighth-grade level

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Malpractice

American Society of Anesthesiologists (ASA)-More than 20 years ago the ASA created its closed claims-analysis project • By instituting risk-management techniques to

improve patient safety, anesthesiologists decreased their liability risk as a group from one of the most frequently sued specialties to a current rank of 20th of the 28 medical specialties listed

Pierce EC. Looking back on the anesthesia critical incidentstudies and their role in catalyzing patient safety. Qual SafHealth Care. 2002;11(3):282–283

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Malpractice

If pediatricians are knowledgeable about the medical conditions that have produced successful malpractice suits, they can institute risk-management techniques that can be effective for both improving patient safety and reducing risk of liability

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EMTALA

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EMTALA

Emergency Medical Treatment and Active Labor Act • Enacted by congress in 1986 as part of the

Consolidated Omnibus Budget reconciliation Act (COBRA) of 1985 (42 U.S.C. §1395dd)

• “Anti-dumping law”• Prevents hospitals from transferring uninsured or

Medicare/Medicaid patients to public hospitals without at minimum, providing a medical screening examination (MSE) to ensure they were stable for transfer

• 24 L.P.R.A. § 3115 (2006)

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EMTALA

Requires hospitals with emergency departments to screen and treat the emergency medical conditions of patients in a non-discriminatory manner to anyone, regardless of their ability to pay, insurance status, national origin, race, creed or color

Technical advisory group convened in 2005 by the Centers for Medicare & Medicaid Services (CMS) to study EMTALA

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EMTALA

The purpose of the MSE is to determine whether an emergency medical condition (EMC) exists, as defined by EMTALA• Nursing triage does NOT qualify as MSE

EMC• “a condition manifesting itself by acute symptoms

of sufficient severity (including severe pain) such that the absence of immediate medical attention could reasonably be expected to result in placing the individual’s health [or the health of an unborn child] in serious jeopardy, serious impairment of bodily function, or serious dysfunction of bodily organs”

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EMTALA

Applies when an individual “comes to the emergency department”

Dedicated emergency department definition• A specially equipped and staffed area of the

hospital used a significant portion of the time for initial evaluation and treatment of outpatients for emergency medical conditions.

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EMTALA

CMS further defines an ED as meeting one of the following criteria• Licensed by the state as an ED• Holds itself out to the public as providing

emergency care• During the preceding calendar year, provided at

least 1/3 of its outpatient visits for the treatment of EMC

EMTALA does not apply to a person soliciting a MSE at a department off the hospital’s main campus facility

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EMTALA

Hospital obligations• A MSE will be provided to any individual who

comes and requests it to determine if an EMC exists Don’t delay!

• Signs must be posted to notify patients and visitors of their rights to a MSE and treatment

• Treatment for an EMC must be provided until resolved or stabilized If the hospital is not capable of solving the

condition an “appropriate” transfer to another hospital must be done

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EMTALA

Hospital obligations• Those institutions with specialized capabilities

are obligated to accept transfers from hospitals who lack the capability to treat unstable EMC

• Must report to CMS or to the state survey agency any time it may have received in an unstable EMC from another hospital

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EMTALA

Requisites for transfers• Stable patients – the treating physician must

determine that no material deterioration will occur during the transfer between facilities

• Unstable patients – Physician must certify that the medical

benefits expected from the transfer outweigh the risks

OR Patient makes a transfer request in writing

after being informed of the hospital’s obligations under EMTALA and the risks of transfer

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EMTALA

Appropriate transfers• Ongoing care must be provided by the

transferring hospital within its capability until the moment of transfer to minimize the risks during the transfer

• Copies of the medical records must be provided by the transferring hospital

• Space and qualified personnel must be confirmed by the institution which requests the transfer

• Transfer must be made with the appropriate medical equipment and qualified personnel

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EMTALA

Penalties• 2 year statute for civil enforcement of any

violation• Termination of hospital/physician Medicare

provider agreement• Hospital fine of up to $50,000/violation• Physician fines $50,000/violation

This includes on-call physicians

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EMTALA

Penalties Hospital may be sued for personal injury in civil

court under a “private course of action”• The receiving facility can bring suit to recover

damages An EMTALA violation can be cited without adverse

outcome to the patient No EMTALA violation can be cited if the patient

refuses examination &/or treatment

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EMTALA-what about the kids?

The MSE and the stabilization of the patient with an identified EMC must not be delayed

Under federal law, a minor can be examined, treated, stabilized, and even transferred to another hospital for emergency care without consent ever being obtained from the parent or legal guardian

Bitterman RA. The Medical Screening Examination Requirement. In:Bitterman RA, ed. EMTALA: Providing Emergency Care under Federal Law.Dallas, TX: American College of Emergency Physicians; 2000:23–65

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EMTALA–what about the kids?

Because the treatment of fractures, infections, and other conditions may broadly be considered as the prevention of disabling complications or EMCs requiring therapy, many centers currently treat all children arriving in the ED, “even if unaccompanied by a parent or caretaker.”

Jacobstein CR, Baren JM. Emergency department treatment of minors.Emerg Med Clin North Am. 1999;17:341–352, x

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Summary-Consent

Must be met for most physician-patient relationships

Do not allow it to delay care for your patient in the ED

Treat emergent situations as such Remember exceptions to consent rule Know the process for conflict resolution/cour order

attainment in your institution Remember to document all issues regarding

consent in the medical chart

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Summary-malpractice

Be familiar with high risk conditions in the emergency department

Take the time to communicate with your patients and their parents

DOCUMENT, DOCUMENT, DOCUMENT Provide clear and concise discharge and follow up

instructions-these are your last chance!!! Participate in developing risk-minimizing strategies

at your institution• Reducing risk for patient reduces liability risk-

everyone wins!!!

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Summary - EMTALA

All patients arriving to an ED must receive a MSE If no EMC exists EMTALA responsibilities cease If EMC exists it must be stabilized to the capabilities

of the institution If it can’t be resolved, an appropriate transfer to an

institution fitted to manage the patient’s condition must occur

The transferring institution’s responsibilities cease at the point of transfer of care when the patient arrives at the receiving institution

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Food for thought...

Physicians would still be well served medically and legally to follow the advice of a 1991 editorial: • “Act like the patient is someone you care about.

Act like you have the courage and intelligence to tell the difference between necessary and unnecessary care and testing, and that you have done for the patient what you would have done for your own family member.”

Henry GL. Common sense. Ann Emerg Med. 1991;20:319–320