1. Legal and Ethical Aspects of Pediatric Emergency Medicine
Carmen M. Lebrón MD FAAP
Emergency Department
San Jorge Children’s Hospital
San Juan, Puerto Rico

2. Disclaimer: este topico se presta para una convencion en si, demas esta decir que no se pueden cubrir todos los topicos en 45 minutos. For the purposes of this lecture we will only discuss consent, since we do have to approach other legal and ethical aspects of the medical management of emergency department patients in general. We can prepare a whole lecture series approaching each individual ethical dilemma in the ED; we have chosen 3 specific topics to broach in this lecture.
Es un tema sumamente importante, hay que recordad que por mas malo que este el turno y por mas presion que sintamos de todas partes, los padres vienen a buscar ayuda para sus hijos porque confian en nosotros.
Eso dicho, voy a cubrir 3 topicos mayores

3. We will discuss… Informed consent in the emergency department
Malpractice
EMTALA

4. Consent

5. 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
Informed consent may be performed easily when the patient is a mature, competent adult

6. 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
Minors commonly present to the emergency
department for medical care and may present accompanied by parents
or caretakers or on their own without legal guardians
1.Boonstra H, Nash E. Minors and the right to consent to health care. Guttmacher Rep Public Policy 2000;3:4–8

7. 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
Minors seek care in the emergency department for a variety of reasons, which often involve
complex psychosocial issues, such as sexually transmitted disease or undiagnosed
pregnancy
1.Treloar DJ, Peterson E, Randall J, et al. Use of emergency services by unaccompanied minors.
Ann Emerg Med 1991;20:297–301.

8. 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
Additionally, adolescence is increasingly understood as
a critical development period, in which teens have the greatest morbidity
and mortality from often preventable, risk-taking behaviors
1. Ziv A, Boulet JR, Slap GB. Emergency department utilization by adolescents in the United States.
Pediatrics 1998;101:987–94

9. 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
For these reasons, emergency physicians must be knowledgeable about medical
and psychosocial issues related to care of minors, especially adolescents
Wilson KM, Klein JD. Adolescents who use the emergency department as their usual source of care.
Arch Pediatr Adolesc Med 2000;154:361–5

10. 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
ED Physicians want to provide competent care in a timely manner to serve the best interest of their patient.
-They want to prevent progression of treatable disease
-They want to reduce pain and suffering
Limitation to access of care should not be permitted
“Times are changing””- because of the changing nature of family structure and the social dynamics of society

11. 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
This policy is usually developed by your institutions’
-business office
-administrative office
-hospital legal council
If triage personnel interprets this policy in a narrow manner they may delay care for children, especially if unaccompanied by a parent

12. 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
In loco parentis includes adult relatives, foster parents, biological father of illegitimate child, persons designated by the parents or state officials designated by child welfare services of the juvenile justice system

13. 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

14. Comentario de emancipacion aqui
Legal Exceptions to Informed
Consent 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.
Comentario de emancipacion aqui

15. Legal Exceptions to Informed
Consent Requirement
Medical Care Setting
The “mature minor” exception
Minor is capable of providing informed consent to the proposed medical or
surgical treatment—generally a minor 14 y or older who is sufficiently
mature and possesses the intelligence to understand and appreciate the
benefits, risks, and alternatives of the proposed treatment and who is able to
make a voluntary and rational choice. (In determining whether the mature
minor exception applies, the physician must consider the nature and degree
of risk of the proposed treatment and whether the proposed treatment is for
the minor’s benefit, is necessary or elective, and is complex.)
Aqui no aplica-
Hay un concepto de pubertad legal, pero es solo para aspectos financieros, no de salud

16. Legal Exceptions to Informed
Consent Requirement
Medical Care Setting
Exceptions based on specific medical
condition
Minor seeks:
• Mental health services
• Pregnancy and contraceptive services
• Testing or treatment for human immunodeficiency virus infection or
acquired 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

17. 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

18. 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
-Puede que necesite envolver a CPS porque como todos sabemos las condiciones medicas se desenvuelven y lo que no es emergente en el momento de su evaluacion puede convertirs en urgente o emergente
-Es importante que para la segunda preguntsa uds se familiarizen con el procedimiento a seguir en la institucion donde usds practican

19. 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

20. Malpractice Medicine is a calling. Medicine is a profession.
Medicine is a business.
People in business get sued.
Gary N. McAbee, DO, JD
Everyone cringes when they hear a colleague say: “remember that kid you signed out to me?”or ‘remember that interesting kid you told me about the other day?”, well, he came back.

21. 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:
c.8oIDJLNnHIE/b /k.C061/StateInformation.htm.
Accessed February 20, 2009

22. 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
Why are we at risk?
Tripleta:practicamos en una especialidad que tiene riesgo(emergencias)
en una subespecialidad que nos pone a riesgo(pediatria)
Selbst, SM, Korin, JB. Preventing Malpractice Suits in Pediatric Emergency Medicine.
1999 American College of Emergency Physicians: pg 5

23. 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
Especially over the weekends, holiday,evenings and nights
Selbst, SM, Korin, JB. Preventing Malpractice Suits in Pediatric Emergency Medicine.
1999 American College of Emergency Physicians: pg 5

24. 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
Pediatric pts cant or wont communicate their problems
Sometimes parents themselves are teens

25. Malpractice Elements
Must have all 4 elements in order for malpractice to occur
Duty
Breech of duty
Harm
Causation
What needs to occur in order for malpractice to occur?

26. 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
There also wasn’t a rule that stated that ALL patients had to be presented
The attending was simply “available”

27. 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

28. 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.
Pediatricians must be familiar w current procedures, treatments and practices
Patients and families assume they have access to the same medical information as any other physician in the country.

29. 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

30. 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

31. 1. Meningitis 2. Appendicitis 3. Specified nonteratogenic anomalies
Most Prevalent Conditions in Pediatric Malpractice Claims Caused 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 With
Pediatric Malpractice Lawsuits in the United States. Pediatrics 2008;122;e1282-e1286

32. 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
appendicitis
children from 12 to 17 years old
Fractures
Appendicitis
testicular torsion
Otros diagnosticos de alto riesgo: laceraciones y cuerpos extraños en las laceraciones
dolor abdominal y vomitos
dolor de pecho
McAbee, GN. Donn, SM., et al. Medical Diagnoses Commonly Associated With
Pediatric Malpractice Lawsuits in the United States. Pediatrics 2008;122;e1282-e1286

33. How do we avoid malpractice suits?

34. 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

35. 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

36. 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
-For example, meningeal signs may be lacking
in a patient with meningitis, and the proper
diagnosis may be missed. However, the physician
who has documented the absence of meningeal
signs has provided some evidence that he or she
considered the possibility of this condition and has
properly evaluated the child

37. Risk Management Techniques-the chart

38. 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
Numerous studies have demonstrated that poor
communication between physicians and parents/patients
is the catalyst for most medical malpractice
lawsuits.

39. 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
The Institute of Medicine has noted that half of
Americans, even among the well educated, do not
understand basic health information.24Institute of Medicine, Committee on Health Literacy. Health
Literacy: A Prescription to End Confusion. Washington, DC: National
Academies Press; 2004

40. 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 incident
studies and their role in catalyzing patient safety. Qual Saf
Health Care. 2002;11(3):282–283

41. 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

42. EMTALA

43. 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. § (2006)
This shifts resposibility to hospitals
Que es? Para que es?
Añadir algo de uncompensated care

44. 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
Envisions a fundamental rethinking of EMTALA that would support development of regionalized emergency systems
-continues to protect patients from discrimination while enabling and encouraging changes in emergency care system design ie direct transport of pts to nonacute care facilities when appropriate

45. 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”
Como define una emergencia?
-May require the use of extensive ED resources, including laboratory testing, radiographic imaging, and subspecialty consultation as needed for diagnosis
In addition to life or limb-threatening conditions, the legal definition of
-An EMC may include conditions with severe pain or
conditions with the potential for serious impairment
or dysfunction if left untreated.

46. 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.
A quienes aplica EMTALA???

47. 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

48. 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
Don’t delay to ask about insurance coverage or methods of payment

49. 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

50. 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
-EMTALA does not apply to the transfer of stable patients -

51. 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

52. 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
$25,000 for hospitals under 100 beds

53. 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
The receiving facility has suffered financial loss as a result of another hospital’s EMTALA violation
An incorrect MSE, or malpractice action do not mean EMTALA violation
Unless there is evidence of coercion
If the MSE or treatment
for an EMC is refused, the ED should document the
offer of appropriate evaluation and care, the discussion
of the risks and benefits, and the competence of
the individual revoking the request for care

54. 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
-Although the ED should attempt to contact the unaccompanied patient’s parent or legal guardian to seek consent for treatment,
-Such care would not only be in the patient’s best interest but also required by federal law.”23
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

55. 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

56. 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

57. 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!!!

58. 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

59. 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