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Informed Refusal: You Are Doing It Wrong
Robert S. Cole
EMC 430W
Eastern Kentucky University
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Assignment:
This is the second assignment associated with your Term Paper for EMC 430W.
Submit a working draft of your term paper to Professor Nancye Davis using the assignment link
above. Your instructor will review your progress and offer feedback.
For the remainder of the course, you will submit a working draft of your term paper for
instructor review. This will allow you to build on your work with ongoing feedback from your
instructor. The guide for these submissions is located in your syllabus.
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Introduction
Refusals are commonly regarded as one of the more risk and liability-laden parts of the
emergency medical services (EMS) job. A refusal, in the context of this discussion, is an
implied, implicit, or explicit decision by the patient to forgo all or part of medical care provided
by a healthcare provider, in this context, EMS providers. For the purposes of this discussion,
transport to a medical facility via EMS is also considered part of the medical care provided.
Refusal incidence vary widely throughout the EMS industry, with rates reported between
10 and 40 percent (Everett, 2016). Reasons for this vary, including delivery model, service area,
and 911/emergency volume versus interfacility/scheduled transport volume.
Liability for refusals is highly variable. As a general rule, paramedics are perceived by
the public as a transportation method for the care of a physician rather than highly qualified
health care providers. Any additional care (no matter how advanced) as an additional and
subordinate benefit to transportation to the care of the physician. As a result of this public
perception, when a patient refuses care, regardless of the circumstances and specifics of the
refusal, this is often perceived as a deviation from the expected norm. Therefore, when an
adverse outcome occurs, it is often viewed through the crystal clear lens of hindsight, and a fault
is often aimed at the paramedics involved.
Defence against liability in these cases may be difficult outside of statutory or qualified
immunity (which may or may not be present in a case). The varied nature of EMS work makes it
difficult to reliably predict “which” refusal may have a poor outcome. Therefore it is incumbent
that all refusals meet a robust legal, clinical, and perceptual standard (Selde, 2015).
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Why refusals matter: Autonomy and Health Care
Autonomy is defined by the Merriam-Webster online dictionary as “The state of existing
or action separately from others” and “to govern self”. In simple terms , autonomy is
self-determination and choice. Autonomy is the difference between freedom and slavery. In a
healthcare context, autonomy is the ability to make your own medical decisions.
In the United States (U.S.), autonomy is sealed within the very foundation of the “law of
the land”: the U.S. Constitution. Particular to this discussion is the fourth amendment.This
amendment states that:
“The right of the people to be secure in their persons, houses, papers, and effects, against
unreasonable searches and seizures, shall not be violated, and no warrants shall issue, but upon
probable cause, supported by oath or affirmation, and particularly describing the place to be
searched, and the persons or things to be seized”
Put simply, acting against the autonomy of one over their own body, amounts to a
“seizure” and depriving them of “security in their persons.” This has been debated and affirmed
in numrous cases before the Supreme Court of the United States (SCOTUS) (Hill, 2016).
Informed Consent and Refusal
The concept of an informed ​refusal is centered on the larger idea of informed ​consent
(Lazar, 1989). Assuming that the patient has been previously determined (or is assumed) to have
the capacity to make an informed decision (as described later in this document) , informed
consent is based on the moral and legal premise of patient autonomy. Autonomy in this
discussion refers to the patient centered belief that the patient has the right to make decisions
about his or her own health and medical conditions. They must give expressed or implied
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voluntary informed consent for treatment and for most medical tests and procedures. Most
medical providers are familiar with this basic concept. This concept of consent would be hollow,
however, without the ability to refuse as well.
How does one construct consent or refusal? Using ethical standards for patient consent in
research, a parallel refusal process is relatively easy to envision. Similar to informed consent for
research or treatment, a refusal must entail a detailed explanation of the risks of refusal, and
other options for treatment, transport or care (Blessing & Forister, 2016). And also similar to
informed consent, it must make clear that refusal of care will not prejudice health care providers
against the patient and other care may occur if appropriate. If a patient feels coerced into refusal,
or fears it may deprive them of access to services in the future, then it is not truly voluntary.
A patient can choose one treatment and yet still refuse another (Colwell, 2016). For
example, A patient could accept a bandage for a wound, yet still refuse transport and instead go
via private vehicle (or not at all) . Paramedics retain a professional responsibility not to act
contrary to good clinical care, but medical decision making is not an all or nothing, either/or
paradigm. Patients retain the balance of power in the decision process.
A patient can also make those choices based on any number or reasons, evidence, beliefs,
even if those beliefs are misconceptions or would result in a poor outcome. A provider's job is to
attempt to provide information to better inform the patient about their decision, rather than to
simply “check a box” on a form.
Competence, Capacity, and Cognition.
Sadly, Capacity and competence are oft confused and poorly understood in healthcare,
particularly in EMS. Paradoxically, very few healthcare settings deal with issues of capacity or
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competence either as frequently, or as independently and without oversight, as EMS providers
do. The ability to determine the capacity to make an informed decision is central to the refusal
process, yet it is often clouded by inadequate education on the matter and persistent dogma
reinforced on the streets.
Competence is a legal determination “adjudicated in a court of law”. At some point, a
Judge must rule on a person's competence based on evidence. Such proof may be from family
members, physicians, and court-appointed examiners. Individuals who are deemed incompetent
are often placed as “wards of the state”, in other words their welfare is the responsibility of the
government. A patient who is a ward of the state may live in an institution, or more likely live
in a group home or other community setting. Other patients who are deemed incompetent may
have guardians appointed for them, such as adult children or a spouse. Once a patient is
considered to be incompetent, they are presumed to remain so until petitioning the court
otherwise.
Capacity, by contrast is a purely clinical determination (Colwell, 2016). It is a fluid
concept, and may change from moment to moment ("Capacity Vs. Competency | Iowa
Department on Aging", 2016). The determination of capacity is based on the patient's ability to
understand and make decisions for his/her own well-being, and their ability to have insight into
their own conditions and circumstances at that moment in time (Colwell, 2016). An example of
the fluid nature of capacity is hypoglycemia. A patient may demonstrate a severely altered level
of cognition and lack of the capacity to make a decision, and yet 10 minutes later regain his full
capacity after resuscitation with dextrose.
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Key to capacity, yet still separate, is cognition. Cognition is “​...the mental action or
process of acquiring knowledge and understanding through thought, experience, and the
senses.” ("Cognition", 2016). It is possible for a patient to have cognition, but not capacity. It is
not possible to have capacity without basic cognition. An example populist example of this
would be John Nash , the mathematician. In his biographical film (​A Beautiful Mind, 2001) he
clearly had excellent ​cognition, but it could be argued that his delusions prevented him from
having ​capacity.
The Fallacy of “Orientation” and the importance of a proper assessment.
“Orientation” as it is used in EMS, commonly refers to the patient's relationship to his
world. Does he know who he is? Where he is? What time is it? And does he understand the basic
situation or events surrounding him at that moment. This is commonly referred to “Alert and
Oriented x 4”, and is often used as the sole basis for determining a patient's capacity to make a
decision. This is a fallacy, however. Key to this error is a lack of understanding how to assess
cognition and capacity.
Orientation typically requires only the most rudimentary of cognition and awareness. As
a case in point: the stereotypical drunken soldier on leave at a bar “just off post”. Even with
exceptionally high blood alcohol content (BAC), that soldier/sailor can shout at the top of his
lungs his name and rank (who he is), his unit (where he is and where he lives), the approximate
date, and the general situation surrounding his drunken state. Many will also be able to loudly
relate their general orders, the Ranger Creed, as well as sing their service anthem. And yet, he
still lacks anything resembling capacity.
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It is important to note it is not the presence of alcohol (even in such extreme quantities)
that determines capacity. In many urban EMS agencies, providers encounter homeless patients
with BAC exceeding that of that drunken soldier/sailor on a daily basis, yet those patients can
demonstrate a level of capacity that the aforementioned servicemember cannot.
The key to determining the level of capacity for decision making is the assessment. Far
more than a mere set of orientation questions, the patient's cognitive function must be assessed.
Furthermore, it must be an evidence-based, validated assessment applicable across a wide variety
of situations.
As discussed above, cognition alone does not equal capacity, although it is an essential
component. To marry cognition to capacity, one must look at the patient’s state of mind at that
present moment. A trifecta of conditions speaks to this: Suicidality, homicidality, and disability.
When a patient has cognition but expresses one of these three things, then they do not have
capacity.
Most concerning for the determination of capacity is the disability. Mental disability
includes hallucinations, delusions, and “lacking insight into his need for treatment.” It also
includes an “inability, by reason of mental illness, to achieve a rudimentary understanding after
conscientious efforts at explanation of the purpose, nature, and possible significant risks and
benefits of treatment.” Expressed another way mental disability must be so profound they are
unable to comprehend the danger of refusing treatment apparently, as assessed by the patient
verbally expressing those risks back to the provider. In its most severe state, mental disability is
often termed “gravely disabled” in state mental health statutes and is often a criterion for
protective custody.
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Obtaining a more robust refusal.
Many providers have their own “take” on how to conduct a refusal. While is imperative
that the provider makes his process as robust as possible as a defense against future litigation, it
is equally important that the provider seizes every opportunity to discover potential clinical
problems that may warrant further action as well. In other words, the responsibility of the EMS
provider to look after the patient’s well-being does not end when the patient expresses a desire to
refuse care or puts pen to paper.
A fundamental weakness in many EMS refusals is speed. Many providers are under
pressure to “clear the call” to return to service. Others may deem a call a lower acuity if the
patient desires to refuse care. This pressure often results in a shallow assessment and a narrow
perspective on the options presented to the patient. Conversely, a complete assessment takes
time, as does informing the patient of their options and risks associated with those options.
This time is used to obtain a good assessment, observe the patient over a period, and assess the
patient's motivations for refusing care in addition to simply having the patient sign a refusal
form. In many ways, a good refusal should require one of the most detailed examinations and
documentation challenges experienced by a paramedic.
As previously discussed, determining capacity requires a cognitive assessment. The
Folstein Mini-Mental State Examination (FMMSE) is one such assessment, although there are
others such as the General Practitioner Assessment of Cognition (GPCOG),
Originally conceived in 1975 to screen for dementia and cognitive impairment, the FMMSE has
been used extensively in screening for cognition in mental health exams, primary care,
psychological testing, and emergency settings. It has been translated into over ten separate
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languages as well. A handful of EMS agencies has incorporated some or all of the FMMSE into
their exam and refusal process.
The exam itself is brief, taking between 5 and 10 minutes. It requires no specialized
equipment and is fully applicable to a “field environment”. It assesses registration, attention,
calculation (math) ability to follow commands, and of course orientation. Critics of the exam
point out that some subtle cognitive impairment may still be missed, but for the purposes of
refusals and capacity, it suffices quite well. It far surpasses other standardized assessments
commonly taught in paramedic programs, and a “positive” result clearly indicates the patient is
indeed impaired. In the FMMSE, any score above 24 (out of 30) implies normal cognition.
In addition to a cognitive assessment, a standard physical exam is required. Different EMS
agencies have different (or no) standards to what a minimum exam should be, but in general, it
should consist of:
● A full set of vital signs including blood pressure, heart rate, and rhythm, pulse oximetry,
and respiratory assessment.
● A brief neuro assessment including the patient's ability to ambulate at their own baseline
unassisted.
● A reassessment, to establish if any deviation from the original assessment is noted.
A robust refusal includes attempting to address any root causes of the assessment. A
patient should have been asked “why” they are refusing care, and that reason documented. If
possibly, the provider should attempt to address these root causes, and documented the results as
well.
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For example, a patient may wish to refuse transport for their chest pain, solely because
they are concerned about the care of their disabled spouse. A prudent paramedic could address
these concerns by offering to call a family friend to “sit” with the spouse until the patient’s return
or family could arrive. By addressing these “root causes”, the provider transitions from merely a
witness documenting an act of refusal, to a true patient care provider. Documenting and
addressing these root causes also provide legal defensibility for the act of refusal, illustrating the
lengths the EMS providers attempted to go to address the patient's concerns and provide
transport.
Documentation
A key principle of healthcare documentation is that “ if it is not written down, it didn't
happen”(Allen, 2016). This is especially true in obtaining informed refusal of care. One should
look at the documentation of refusals as not merely checking a box, but as building a robust
defense before the event is ever questioned. At a minimum a robust refusal should contain:
● All vitals obtained, regardless of stability and redundancy
● All assessments performed and all clinical observations, no matter how mundane.
● Expressed reasons for refusal and any attempts to reconcile those root causes
● Extenuating circumstances
● Advising the patient of the limitations of a prehospital field assessment.
● Multiple expressed offers of transport. At least three separate offers to transport would
seem prudent and defensible.
● The patient’s ability to express back to the provider the risks involved in refusal.
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Also, there are some points a diligent EMS provider should consider. Just as an informed
consent form must include a statement that a refusal to undergo a therapy or refusal to participate
in a study will not impact any other care provided to the patient, an informed refusal should
inform a patient that they can, at any time, call EMS again to provide care, even if it is
immediately afterward.
Refusal is complete: Now what?
In many cases, the call is over once the unit is “available for service”. A robust refusal
should involve risk mitigation however. Before a patient is left, providers should consider the
patient's overall safety. Is there a responsible adult who will be able to assist the patient and
prevent further illness or injury, such as a fall, after EMS departs? Do they have the ability to call
for help via cell phone or medical alert? Were they advised to follow up with their physician, or
did the EMS provider offer to call the doctor's office to facilitate an appointment the next
business day? If they (the patient) intends to present to the Emergency Room via privately
owned vehicle (POV), did EMS providers “call ahead” to facilitate care? While each of these
questions seems small and inconsequential, taken together these present the EMS provider as
caring, diligent, and looking out for the best interest of the patient. When EMs providers “go
the extra mile”, a refusal of transport by the patient does not look like a ​refusal to care.
In all these examples, regardless of the patient’s ultimate decision or destination, it
should be made clear that transport is being offered. Ultimately the public still views EMS as a
transport service first, and in many cases, this perception is difficult to break. When EMS
deviates from the perceived “norm”, then the extra documentation as a patient advocate will
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mitigate any knee jerk reactions, and negative impressions had after the fact by those with 20/20
hindsight.
Avoiding pitfalls and traps.
While refusals are a point of elevated risk, there are many specific situations and factors
that an EMS provider should be especially cautious around. A brief discussion of these follows.
Minors are a unique challenge for EMS providers, especially if their parents or guardians
are not around. A minor can clearly be treated under the doctrine of implied consent if an
emergency is present, but the doctrine is considerably less clear in cases where a medical need
exists but no emergency is imminent. As a general rule, if there are no exigent circumstances, a
minor's wishes would be given due consideration. While a minor's autonomy is not absolute as
an adult’s, it should also be respected when possible. Considerations such as the relative maturity
of the patient, the living status, marital status, and emancipation also should be considered.
Additionally, many states have certain provisions for minors to seek care without parental
approval certain circumstances, such as rape, incest, sexually transmitted diseases and
contraception.
Intoxication may be another challenge. Simply consuming alcohol, contrary to popular
dogma, does not relieve a patient of their decision-making capacity (Australian Capital Territory
Health, 2016). Autonomy is more resilient and perseveres beyond simple consumption. The
determination of intoxication, and by extension lack of capacity, must be made on clearly
articulable and observable assessments. It is not enough to simply document an arbitrary amount
of alcoholic beverage consumption. One must put it into the context of the situation, apply a
timeframe to that consumption, and must document physical effects. The presence of slurred
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speech, difficulty completing cognition assessments, or inability to ambulate safely are more
objective than simply saying the patient was “drunk”.
Dementia presents a unique challenge. When asked about patients with any of this broad
spectrum of cognitive impairment, a provider will typically conjure an image of a profoundly
impaired patient in a nursing home. In reality, many patients with mild dementia often live
undetected or (relatively) independently in the community with family. In many cases, the
patient will have varying levels of cognition throughout the day. Often the patient may be able to
answer basic orientation questions, and dementia will only be suspected when completing a
details exam. The family often will be vague on the topic, stating the patient “may have
dementia” or expressing personal opinions when there are no formal diagnosis or adjudication in
place supporting their “feelings”.
A prudent provider would address this situation by beginning with a cognitive assessment
such as the FMMS, but also asking questions about how the patient handles “their affairs”. Do
they still manage their bank account? Does the patient have an appointed guardian? Do they have
a power of attorney? Have they been rendered incompetent in a court of law? Simply having a
family member stating the patient has a vague and unsubstantiated history of dementia is not
enough (in and of itself) to assume incapacitation of decision making. It must be confirmed by
assessment or other evidence.
It is also worth noting that dementia is a diagnosis that occurs over multiple visits
showing cognitive impairment over a minimum of 6 months. “Acute” or sudden onset of
dementia seldom is dementia, and other medical or traumatic causes should be strongly
considered.
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Prisoners and their autonomy are often misunderstood by EMS providers. The history of
tension and conflict between healthcare providers and the officials charged with the care of
prisoners and even the prisoners themselves is storied and well documented (Mendelsohn, 2011).
There is much misunderstanding by EMS providers when faced with prisoners. EMS providers
often assume that representatives of the custodial agency (i.e. law enforcement or corrections)
can make medical decisions on behalf of the patient. The supreme court offers a unique
perspective, stating that such decisions can only be made when the security and safety needs
outweigh the needs of the patient (​Stouffer v. Reid; 2008). In all other cases, the courts advise
that providers “​ must initially remove it [the decision] from the prison context” and consider
autonomy in a similar light as if the patient was not a prisoner (Thor v. Superior Court; 1996). In
other words, in many cases, prisoners retain their medical decision-making capacity (and refusal
to refuse care), even while incarcerated.
Iatrogenic Barriers and Biases
At times, a healthcare provider is his own worst enemy. There are a number of biases and
internal factors that may be considered when obtaining a refusal of any type (Tomstom, 2016).
One of the most significant is fatigue. In an ideal world, the quality of a paramedics care and
diligence would not vary significantly by shift length, time of day, or proximity to shift change.
In reality, these can become factors in the critical thinking and attention to detail that obtaining a
robust refusal requires. A good paramedic should recognize this in him/herself and actively strive
to set these factors aside. More Importantly, a well-designed system will monitor, and account
for them on a macro level.
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Another bias may be based on the location of call type. Every system has “that spot”
where the perception is all the calls have a low acuity. These may be homeless shelters, parks, or
certain neighborhoods. Certain call types also routinely get a collective moan when dispatched.
An example would be the stereotypical “third party report of an unconscious subject on the park
bench” or “assist PD with an intoxicated subject”. While these calls often remain true to form,
approaching them in autopilot is poor practice.
Shift length and type can also influence the frequency of refusals. Some systems have
noticed an upswing in refusals in the second half of longer shifts (16 and 24 hours) or when close
to the end of a shift, regardless of shift length. Fatigue plays a role in the percentage of refusals
in a system, and agencies with a substantial amount of mandatory overtime or high unit hour
utilization may also see predictable “peaks” or refusals. Supervisors and medical directors
should be observant for these patterns, and providers themselves should be cognizant of this
phenomena.
Gateway phenomena is another bias to overcome (Bouthillet, 2016). Here, a provider
feels an obligation to “reduce waste”. Often the provider believes certain patients or patient
types “don’t need an ER”. This attitude will often invert the decision-making process for the
provider, forcing them to look for reasons not to transport instead of searching for reasons to
transport. There are certainly situations where transport may not be the most efficient, and
occasionally there are situations where transport is not indicated or even contraindicated; but
these should be rare, evidence-based, and protocol-driven with strong medical director
oversight, not informed by a field providers “gut feeling”.
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“No Patient found” syndrome is a tendency for providers to under document a response
(Fowler, 2007). A provider may make contact, do a rudimentary (or even incomplete assessment)
and encourage a patient to seek care via other means, and in the end document the call as “no
patient found” or “no patient contact.” This trend is seen to avoid an ever increasing
documentation burden with EHR’s, to avoid getting off shift late or simply return to bed due to
fatigue.
Alternative destination vs. patient choice
It is important for the provider to consider that refusal of care and refusal of ambulance
transportation are not the same. A patient may accept assessment, and even treatment, but still
decline (at any time) transport. A patient may accept splinting, for example, and chose to seek
further care via POV. In some cases, this may be an acceptable, or even preferred course of
action. Services should manage these situations via flexible protocols and medical oversight.
When a patient chooses an alternative method of transportation, they should still be
informed of any risks, and the level of documentation should be similar to a traditional refusal.
This should not be taken to imply that EMS should not be allowed to facilitate the patient’s
choice. Regardless if a patient is transported by EMS, EMS providers have an affirmative
responsibility to advocate and seek the patient's best interest. A provider may “call ahead” to the
intended ER, call the patient’s private physician to facilitate care or any number of other
reasonable actions to ensure the patient received appropriate care.
Summary
Common wisdom from veteran medics holds that refusals are the most litigious and
difficult calls to document, yet little guidance is provided on how to document these calls well.
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Even less education is provided on the level of assessment, the differences between competency
and capacity, and how to make a refusal an informed decision. In the case of refusal of care, this
truly is a synergy of both medical and legal fields, yet many providers often ignore both equally.
EMS providers can look to existing case law and legal precedent for informed consent to
provide insight on documentation of refusals of care. Similarly, the science of cognition and a
comprehensive assessment of other aspects of medicine can inform on the clinical capacity of a
patient to refuse care. Despite the existence of this information, dogma and misinformation
persist at the street level of EMS, where these incidents occur. Issues of consent, capacity, and
documentation seldom receive the same attention as cardiology, pharmacology, or even incident
command, despite occurring in up to 30 percent of EMS incidents. Through more in-depth
education, a more informed EMS provider can construct a more robust informed refusal, which
will lead to better patient care and better EMS practice.
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Citations
A Beautiful Mind. (2001). USA.
Australian Capital Territory Health,. (2016). ​Standard Operating Procedure Consent and
Treatment: Capacity and Substitute Decision Maker. Canberra, Australia.
Blessing, J. & Forister, J. (2016). ​Introduction to research and medical literature for health
professionals (4th ed., pp. 12-22). Burlington, MA: Jones & Bartlett Learning.
Bouthillet, T. (2016). RE: Refusal/AMA/No transport rates?
Capacity Vs. Competency | Iowa Department on Aging. (2016). ​Iowaaging.gov. Retrieved 13
October 2016, from ​https://www.iowaaging.gov/capacity-vs-competency
Cognition. (2016). ​Oxford English Dictionary. Retrieved from
https://en.oxforddictionaries.com/definition/cognition
Colwell, C. (2016). Know When Uncooperative Patients Can Refuse Care and Transport.
Journal Of Emergency Medical Services, ​41(8).
Allen, L. (2016). ​Documentation. ​www.jems.com/ems-insider. Retrieved 13 October 2016, from
http://www.jems.com/ems-insider/articles/2015/10/documentation.html
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Everett, A. (2016). RE: Refusal/AMA/No transport rates?
Fourth Amendment. (2016). ​LII / Legal Information Institute. Retrieved 13 October 2016, from
https://www.law.cornell.edu/constitution/fourth_amendment
Fowler, R. (2007). ​The Greatest Risk. Presentation, Multiple Locations.
Judson, K. & Harrison, C. (2016). ​Law & ethics for health professions (7th ed.). New York, NY:
MCGraw Hill.
Hill, B. (2016). ​The Constitutional Right to Make Medical Treatment Decisions: A Tale of Two
Doctrines. ​Scholarlycommons.law.case.edu. Retrieved 13 October 2016, from
http://scholarlycommons.law.case.edu/cgi/viewcontent.cgi?article=1142&context=faculty_publi
cations
Mendelsohn, D. (2011). The Right to Refuse: Should Prison Inmates Be Allowed to Discontinue
Treatment for Incurable, Noncommunicable Medical Conditions?. ​Maryland Law Review, ​71(1),
295-338. Retrieved from ​http://digitalcommons.law.umaryland.edu/mlr/vol71/iss1/14/
J. Michael STOUFFER, Commissioner of Correction v. Troy REID., No. 243, Sept. Term,
2008. STOUFFER v. REID (Court of Special Appeals of Maryland 2008).
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Lazar, R. (1989). ​EMS law (pp. 65-87). Rockville, Md.: Aspen Publishers.
Selde, W. (2015). Know When and How Your Patient Can Legally Refuse Care. ​Journal Of
Emergency Medical Services, ​40(3).
Thor v. Superior Court (Andrews), [No. S026393. Jul 26, 1993.] (THE SUPERIOR COURT OF
SOLANO COUNTY 1996).
Tomstom, T. (2016). RE: Refusal/AMA/No transport rates?.