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6Medical Mistakes and
Patient Safety
Flirt/SuperStock
Learning Objectives
After reading this chapter, you should be able to
1. Explain reasons for the prevalence of medical mistakes.
2. Describe mistakes that threaten patient safety.
3. Analyze how ethical health care organizations address the
vexing problem of medical mistakes.
4. Examine the legal, regulatory, political, and administrative
attempts to reduce threats to
patient safety.
5. Understand tort law and what is meant by tort reform.
6. Examine the ethical implications of health care
organizations’ responses to medical mistakes.
7. Comprehend the significance of landmark legal cases that
shape the current climate of quality
improvement and risk management.
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resale or redistribution.

Section 6.1The Extent of Medical Mistakes
Introduction
In this chapter we will analyze how ethical health care
organizations address the serious
problem of medical mistakes. We will also take an in-depth look
at some legal, regulatory,
political, and administrative solutions that may lessen the risk
to patients while also protect-
ing organizations from legal liability. Throughout this chapter
we will also explore the ethical
implications of this issue and how an awareness of the ultimate
ends of health care can yield
practical solutions.
6.1 The Extent of Medical Mistakes
Until 1999, most Americans were unaware of the extent of
medical errors in health care. That
year, the Institute of Medicine (IOM) released the report “To
Err Is Human: Building a Safer
Health System” (IOM, 1999). Based on a series of studies, “To
Err Is Human” concluded that up
to 100,000 people die from preventable medical errors every
year in the United States (IOM,
1999). The shocking statistic thoroughly shook the collective
trust in American health care.
Another IOM report, published in 2001 and titled “Crossing the
Quality Chasm,” furthered
the point that health risks to patients from health care providers
due to preventable human
errors were much too high. (See Figure 6.1 for a comparison of
the percentage of medical
errors made in various countries.)

Figure 6.1: Medical, medication, or lab test errors, 2009–2011
This graph compares the percentage of medical errors made in
various countries. Why do you think
that the United States has the highest percentage of medical
errors of the seven countries listed?
Source: Schoen, C., Osborn, R., Squires, D., Doty, M. M.,
Pierson, R. & Applebaum, S. (2011). New 2011 survey of
patients with complex
care needs in 11 countries finds that care is often poorly
coordinated. Health Affairs. Data retrieved from https://www
.commonwealthfund.org/chart/medical-medication-or-lab-test-
errors-past-two-years
Case Study: A Tragic Medical Mistake
In early December of 1995, a seven-year-old boy was admitted
to a South Florida hospital
to undergo ear surgery to remove scar tissue resulting from two
earlier surgeries. Although
the young boy was frightened, his mother played with him
beforehand and ensured him he
would be fine and would even have an early Christmas surprise
when he woke up from the
surgery.
During the surgery, the boy would be under general anesthesia,
and his ear would be
injected with lidocaine and swabbed with a form of adrenaline
called epinephrine. The pro-
cedure used to prepare each of these drugs for use in surgery
occurs frequently and without
error in hospitals all over the country. Unfortunately, on this
day, a mistake occurred and
the two drugs were inadvertently switched. Instead of injecting

the patient with lidocaine,
the physician administered a lethal dose of epinephrine directly
into the boy’s ear. This
immediately caused the boy’s heart rate and blood pressure to
rise at an alarming rate. The
head of anesthesia was rushed into the operating room (OR) to
try and bring the boy’s heart
rate and blood pressure down. He was able to temporarily
stabilize the boy, but soon after
the patient’s heart rate and blood pressure began rapidly
decreasing, and then he stopped
breathing. The head of anesthesia performed CPR on the patient
for more than 90 minutes.
While he was finally able to resuscitate the patient, it was
evident that the boy was in a deep
coma and would probably not recover. He was rushed to the
intensive care unit and his
mother was informed by the surgeon and the head of anesthesia
that her son was in a coma
and most likely brain dead. After keeping the boy on a
ventilator for almost 24 hours, it
was apparent to his parents and older sister that he was not
going to regain consciousness.
Therefore, the parents agreed to remove the ventilator, and the
boy passed away.
The hospital’s risk manager was called in during the incident,
and while the surgeons were
speaking with the child’s parents, she went into the OR and
collected everything that was
left from that specific surgery. Initially, she decided to lock
away all the syringes, vials, and
cups that were used; however, once she received the details of
the incident, she knew she
had to send these items out to be tested by an independent lab.
The risk manager promised

the parents she would get to the bottom of what occurred during
the surgery.
Three weeks after the boy’s death, the risk manager received the
results of the independent
test which were conclusive in showing that the drugs had been
inadvertently switched and
that the young boy had died due to human error. By this time,
the family had hired malprac-
tice attorneys. The risk manager and the head of anesthesia met
with the family and their
lawyers to share the results of the test and admit the truth. It
was important to them and
the entire hospital administration to admit this mistake to the
grieving parents, determine
what needed to be done to try and ease their pain, and work on a
solution to ensure that
such a mistake would never happen again.
An undisclosed settlement was made and the parents met with
the surgeon to ask the ques-
tions that had been troubling them since their son’s death. They
wanted to know if their son
had suffered, if he had known he was in trouble, and,
surprisingly, if they could continue
using the hospital for their medical care. They also wanted to
share their son’s story with
everyone who would listen to ensure the same mistake would
not occur again in the future.
At that point, the case was closed for the family; however, the
case was far from closed for
the hospital.
(continued on next page)

Introduction
In this chapter we will analyze how ethical health care
organizations address the serious
problem of medical mistakes. We will also take an in-depth look
at some legal, regulatory,
political, and administrative solutions that may lessen the risk
to patients while also protect-
ing organizations from legal liability. Throughout this chapter
we will also explore the ethical
implications of this issue and how an awareness of the ultimate
ends of health care can yield
practical solutions.
6.1 The Extent of Medical Mistakes
Until 1999, most Americans were unaware of the extent of
medical errors in health care. That
year, the Institute of Medicine (IOM) released the report “To
Err Is Human: Building a Safer
Health System” (IOM, 1999). Based on a series of studies, “To
Err Is Human” concluded that up
to 100,000 people die from preventable medical errors every
year in the United States (IOM,
1999). The shocking statistic thoroughly shook the collective
trust in American health care.
Another IOM report, published in 2001 and titled “Crossing the
Quality Chasm,” furthered
the point that health risks to patients from health care providers
due to preventable human
errors were much too high. (See Figure 6.1 for a comparison of
the percentage of medical

errors made in various countries.)
Figure 6.1: Medical, medication, or lab test errors, 2009–2011
This graph compares the percentage of medical errors made in
various countries. Why do you think
that the United States has the highest percentage of medical
errors of the seven countries listed?
Source: Schoen, C., Osborn, R., Squires, D., Doty, M. M.,
Pierson, R. & Applebaum, S. (2011). New 2011 survey of
patients with complex
care needs in 11 countries finds that care is often poorly
coordinated. Health Affairs. Data retrieved from https://www
.commonwealthfund.org/chart/medical-medication-or-lab-test-
errors-past-two-years
Case Study: A Tragic Medical Mistake
In early December of 1995, a seven-year-old boy was admitted
to a South Florida hospital
to undergo ear surgery to remove scar tissue resulting from two
earlier surgeries. Although
the young boy was frightened, his mother played with him
beforehand and ensured him he
would be fine and would even have an early Christmas surprise
when he woke up from the
surgery.
During the surgery, the boy would be under general anesthesia,
and his ear would be
injected with lidocaine and swabbed with a form of adrenaline
called epinephrine. The pro-
cedure used to prepare each of these drugs for use in surgery
occurs frequently and without
error in hospitals all over the country. Unfortunately, on this

day, a mistake occurred and
the two drugs were inadvertently switched. Instead of injecting
the patient with lidocaine,
the physician administered a lethal dose of epinephrine directly
into the boy’s ear. This
immediately caused the boy’s heart rate and blood pressure to
rise at an alarming rate. The
head of anesthesia was rushed into the operating room (OR) to
try and bring the boy’s heart
rate and blood pressure down. He was able to temporarily
stabilize the boy, but soon after
the patient’s heart rate and blood pressure began rapidly
decreasing, and then he stopped
breathing. The head of anesthesia performed CPR on the patient
for more than 90 minutes.
While he was finally able to resuscitate the patient, it was
evident that the boy was in a deep
coma and would probably not recover. He was rushed to the
intensive care unit and his
mother was informed by the surgeon and the head of anesthesia
that her son was in a coma
and most likely brain dead. After keeping the boy on a
ventilator for almost 24 hours, it
was apparent to his parents and older sister that he was not
going to regain consciousness.
Therefore, the parents agreed to remove the ventilator, and the
boy passed away.
The hospital’s risk manager was called in during the incident,
and while the surgeons were
speaking with the child’s parents, she went into the OR and
collected everything that was
left from that specific surgery. Initially, she decided to lock
away all the syringes, vials, and
cups that were used; however, once she received the details of
the incident, she knew she

had to send these items out to be tested by an independent lab.
The risk manager promised
the parents she would get to the bottom of what occurred during
the surgery.
Three weeks after the boy’s death, the risk manager received the
results of the independent
test which were conclusive in showing that the drugs had been
inadvertently switched and
that the young boy had died due to human error. By this time,
the family had hired malprac-
tice attorneys. The risk manager and the head of anesthesia met
with the family and their
lawyers to share the results of the test and admit the truth. It
was important to them and
the entire hospital administration to admit this mistake to the
grieving parents, determine
what needed to be done to try and ease their pain, and work on a
solution to ensure that
such a mistake would never happen again.
An undisclosed settlement was made and the parents met with
the surgeon to ask the ques-
tions that had been troubling them since their son’s death. They
wanted to know if their son
had suffered, if he had known he was in trouble, and,
surprisingly, if they could continue
using the hospital for their medical care. They also wanted to
share their son’s story with
everyone who would listen to ensure the same mistake would
not occur again in the future.
At that point, the case was closed for the family; however, the
case was far from closed for
the hospital.

Reducing Foreseeable Risks
Over the past several decades, health care providers have
devoted significant attention to
addressing the problem of medical errors. Nonetheless, errors
that endanger patients per-
sist. According to a 2010 study, there were 35 reported cases of
wrong-site craniotomies in
the United States prior to the time of the study (Cohen,
Mendelsohn, & Bernstein, 2010). The
study found that there were four major categories of
contributing factors to wrong-site cra-
niotomies: (a) communication breakdown, (b) inadequate
preoperative checks, (c) technical
factors and imaging, and (d) human error. All of these factors
boil down to human errors that
stem from violating multiple fail-safes intended to prevent such
mistakes. In the majority of
cases, this is a result of a breach in policy, guidelines, or
protocol. Since there are usually sev-
eral different lines of redundant checks, each error often
represents multiple breaches.
For example, 53-year-old Regina Turner was admitted to a
respected hospital in St. Louis,
Missouri, for a common brain surgery known as a craniotomy
bypass (Doyle, 2013). A
Case Study: A Tragic Medical Mistake (continued)

The risk manager, CEO, head of anesthesia, and, at times, even
the surgeon, traveled to con-
ferences around the country to share the story of what had
happened in their OR that day.
As the story spread, the group was invited to speak at more and
more conferences, both
in the U.S. and, eventually, abroad. A group of physicians from
Japan even traveled to the
hospital to discuss the case with those involved so they could
better their own procedures
in the OR.
In addition to sharing the story with other medical
professionals, the hospital made many
internal changes to their procedures. Drugs were no longer
permitted to be poured from
a bottle into a cup and transferred to a syringe; the new policy
is to use a special filtering
device to transfer the drugs directly to a syringe. In addition,
the medicines are to be placed
in the syringes one at a time to ensure that there is no chance of
a mix-up. The entire pro-
cess must be observed by two nurses who must also verify the
contents. Lastly, all medical
staff have been trained not to place epinephrine into a syringe
or discard any vials until
surgery is finished and patients are checked for complete
stabilization.
This case study is about a true occurrence that was covered in
international news for many
years. You can read additional details on the case, what
happened after, and how things
have changed in health care due to this case in the following
articles:

• “Diagnosing Medical Errors: In the Wake of Widely
Publicized Mistakes, Doctors
Try To Make Hospitals Safer”
• “Tragedy Teaches A Lesson: Sharing Data Saves Lives”
• “How Can We Save the Next Victim?”
Discussion Questions
1. Should any of the individuals in the OR have been charged
with a crime, such as
negligence or involuntary manslaughter? If so, which
individuals and why?
2. What, if any, disciplinary action(s) should the hospital take
toward those involved in
response to this incident?
preoperative photograph of the woman on
her hospital bed shows an indelible mark
on her left temple to mark the site of the
surgery (Doyle, 2013). Such marks have
become commonplace in hospitals as one
in a long line of fail-safes to prevent
wrong-site surgeries. In this case, how-
ever, the obvious black mark did not work.
The neurosurgeon and his team allegedly
performed the craniotomy on the right

hemisphere of her brain, and a postopera-
tive photograph shows a patient with the
bandages clearly on the right side of her
head (Doyle, 2013). As a result of the
botched surgery, a formerly walking and
talking patient was now wheelchair bound
and unable to speak clearly (Doyle, 2013).
The appropriate response to such an incident, though, is
complicated. While a hospital may
have an ethical obligation to reduce the risk of wrong-site
surgeries to below some agreed-
upon threshold (0.05%, for example), it is not clear that there is
an ethical imperative to
spend millions of additional dollars to reduce that risk by a
small margin (to 0.045%, for
example). This is especially true if the hospital could be
accused of shirking the ethical prin-
ciple of beneficence by ignoring other pressing needs in the
process. Where should the line be
drawn? Health care organizations must be pragmatic about
marginal gains that cost dispro-
portionately too much to achieve or may even be futile to
pursue.
Iatrogenic Morbidity and Mortality
Whenever a patient becomes inadvertently or unintentionally
sick or injured during the
course of receiving medical care, the result is called an
iatrogenic injury. Morbidity indicates
illness, while mortality refers to the death of the patient.
Iatrogenic morbidity and mortality
do not necessarily result from medical errors or negligence.
Morbidity or mortality may be
produced by foreseeable incidents related to treatment. They
can also result from complica-

tions or adverse reactions that could not be prevented. Often,
however, the iatrogenic injury
could and should have been prevented.
The principle of nonmaleficence—minimizing unnecessary risks
and avoiding preventable
harm—imposes an ethical duty on health care professionals to
minimize unnecessary risks
and avoid preventable harms. Other industries can offer ideas
about how to reduce the risk
of harm due to human error. For example, in the 2007 New
Yorker article “The Checklist,” sur-
geon Atul Gawande detailed how the aviation industry has
created pilot checklists that item-
ize tasks to be completed before takeoff, flight, landing, and
taxiing. This simple yet effective
system has drastically reduced mistakes ending in death.
Checklists and other redundant fail-
safe interventions can be effective at drastically reducing
iatrogenic morbidity and mortality
in clinical settings (Gawande, 2007). Even so, the health care
industry has been slow to fully
implement these simple strategies (Gawande, 2007, 2009a).
Ben Birchall/Associated Press
Implementing mandatory checklists can help
reduce medical mistakes.
Section 6.2Legal and Administrative Strategies to Ensure
Patient Safety

6.2 Legal and Administrative Strategies to
Ensure Patient Safety
To reduce the risks of medical errors and ensure patient safety,
the United States has adopted
a complex patchwork of laws and administrative strategies. The
most salient of these are
outlined in this section.
State and Federal Regulation of Health Care Organizations
Federal agencies such as the U.S. Food and Drug
Administration (FDA) and the Office for
Human Research Protections provide regulatory frameworks and
oversight to help ensure
the safety of patients, human subjects in research, and
consumers in the United States. In
the 1950s and 1960s, when thalidomide, an anti-nausea
medication prescribed to pregnant
women, was approved for use in the United Kingdom, Canada,
and other countries, the FDA
withheld approval in the United States after hearing reports of
possible harms occurring in
Europe (Potter, 1979). It soon became apparent that the drug
caused horrific birth defects.
Several thousand babies were born with limbs that were
deformed or missing altogether.
The FDA’s refusal was lauded as having spared many American
babies from the same iatro-
genic fate.
In addition to imposing direct requirements to do or not do
particular actions, the federal
government also regulates the safety of health care
organizations by establishing and enforc-
ing requirements that an organization must meet in order to be
eligible for federal reim-

bursement of health care expenses. While the federal
government grants Medicare “deemed
status” to a few private organizations such as the Joint
Commission (see discussion below), it
also maintains direct oversight. The Department of Health and
Human Services, for example,
enforces conditions of participation that regulate patient safety,
among other aspects of care.
Likewise, the Social Security Amendments of 1972 established
professional standards review
organizations. These federally funded organizations were tasked
with reviewing and assess-
ing the medical necessity, appropriateness, and quality of care
given to patients covered by
Medicare. Over time, it became apparent that professional
standards review organizations
were expensive and had not significantly improved the quality
of Medicare patients’ care.
Consequently, Congress replaced them with professional review
organizations (Tax Equity
and Fiscal Responsibility Act of 1982). While similarly named,
professional review organiza-
tions were early adopters of the “outcome-based” revolution in
health care review. Instead
of focusing on the structures and processes of health care
organizations, professional review
organizations adopted outcome standards by which they
assessed quality of care, including
hospital safety. They used the enormous databases of clinical
information that new technol-
ogies were making available in the 1990s to make sophisticated
statistical analyses. These
offered a clearer picture of health care organizations’ practice
standards. Nonetheless, for all
of the sophisticated tracking that professional review
organizations were able to do, the infor-

mation prompted few quality solutions and was unable to help
prevent the quality chasm that
the IOM later reported.
After two decades, professional review organizations were
rebranded as quality improve-
ment organizations. They still report to the Department of
Health and Human Services’
Centers for Medicare and Medicaid Services and still operate
largely as they did before the
name change.
Patient Safety
Many other federal agencies also affect health care
organizations. For example, the Occupa-
tional Safety and Health Administration (OSHA) is in charge of
policing workplace safety. The
U.S. Drug Enforcement Agency has jurisdiction over a long list
of pharmaceuticals known as
controlled substances. It licenses health care organizations and
professionals to prescribe
and handle these drugs safely. The Nuclear Regulatory
Commission licenses and regulates
the use of radioactive materials in health care. The Department
of Homeland Security keeps
close tabs on the radioactive materials that health care
organizations use in order to protect
health care providers, patients, and the public at large from the
potential misuse or abuse of

these volatile materials.
Regulatory frameworks such as these represent one of the ways
the United States tackles
the duty that health care professionals have to conform to the
ethical principle of nonma-
leficence. However, federal oversight through the work of
regulatory requirements is not the
only means of ensuring patient and consumer safety. There is
also a complicated array of pro-
fessional requirements, guidelines, and administrative strategies
intended to reduce the risk
of error and harm in health care. Several of these will be
explored in the sections that follow.
Accreditation of Health Care Organizations
According to the Medicare law, hospitals that voluntarily meet
the accreditation require-
ments of the Joint Commission (previously known as the Joint
Commission on Accreditation
of Health Care Organizations and before that as the Joint
Commission on Accreditation of
Hospitals) are deemed to comply with federal requirements and
therefore are eligible for
Medicare reimbursement. The Joint Commission publishes
standards that hospitals (or other
kinds of organizational health care providers) must meet, upon
inspection, to earn accred-
ited status. Although accreditation remains voluntary, most
hospitals in the United States are
accredited through the Joint Commission, both because they
desire deemed status to receive
Medicare payments and because of the perceived value of the
public and professional cred-
ibility that comes from being accredited.

The Joint Commission (2017) touts the following specific
benefits of accreditation to health
care organizations:
• Helps organize and strengthen patient safety efforts—Patient
safety and quality of
care issues are at the forefront of Joint Commission standards
and initiatives.
• Strengthens community confidence in the quality and safety of
care, treatment,
and services—Achieving accreditation makes a strong statement
to the community
about an organization’s efforts to provide the highest quality
services.
• Provides a competitive edge in the marketplace—
Accreditation may provide a mar-
keting advantage in a competitive health care environment and
improve the ability
to secure new business.
• Improves risk management and risk reduction—Joint
Commission standards focus
on state-of-the-art performance improvement strategies that
help health care orga-
nizations continuously improve the safety and quality of care,
which can reduce the
risk of error or low quality care.
• May reduce liability insurance costs—By enhancing risk
management efforts,
accreditation may improve access to and reduce the cost of
liability insurance
coverage.

Patient Safety
• Provides education to improve business operations—Joint
Commission Resources,
the Joint Commission’s not-for-profit affiliate, provides
continuing support and edu-
cation to accredited organizations with services to help
organizations in a variety of
settings.
• Provides professional advice and counsel, enhancing staff
education—Joint Commis-
sion surveyors are experienced health care professionals trained
to provide expert
advice and education during the on-site survey.
• Provides a customized, intensive review—Joint Commission
surveyors come from a
variety of health care industries and are assigned to
organizations that match their
background. The standards are also specific to each
accreditation program so each
survey is relevant to your industry.
• Enhances staff recruitment and development—Joint
Commission accreditation
can attract qualified personnel who prefer to serve in an
accredited organization.
Accredited organizations also provide additional opportunities
for staff to develop

their skills and knowledge.
• Provides deeming authority for Medicare certification—Some
accredited health care
organizations qualify for Medicare and Medicaid certification
without undergoing
a separate government quality inspection, which eases the
burdens of duplicative
federal and state regulatory agency surveys.
• Is recognized by insurers and other third parties—In some
markets, accreditation is
becoming a prerequisite to be eligible for insurance
reimbursement and to partici-
pate in managed care plans or contract bidding.
• Provides a framework for organizational structure and
management—Accreditation
involves not only preparing for a survey, but maintaining a high
level of quality and
compliance with the latest standards. Joint Commission
accreditation provides guid-
ance to an organization’s quality improvement efforts.
• May fulfill regulatory requirements in select states—Laws
may require certain
health care providers to acquire accreditation for their
organization. Those organi-
zations already accredited by the Joint Commission may be
compliant and need not
undergo any additional surveys or inspections.
• Provides tools for accredited organizations—The Leading
Practice Library offers
good practices submitted by accredited organizations. The
Targeted

Solution
s Tool,
an interactive web-based tool from the Joint Commission Center
for Transform-
ing Health care, allows accredited organizations to measure
their organization’s
performance and help them find customized solutions for
challenging health care
problems.
• Aligns health care organizations with one of the most
respected names in health
care—Being accredited by the Joint Commission helps
organizations position for the
future of integrated care.
Source: © The Joint Commission, 2018. Reprinted with
permission.
Among its other initiatives, the Joint Commission annually
publishes national patient
safety goals for various health care settings

(http://www.jointcommission.org/standards
_information/npsgs.aspx). Useful guidance on reducing errors
by improving the quality of
health care delivery is available from the Institute for
Healthcare Improvement (http://www
.ihi.org), although the institute has no regulatory authority.
Patient Safety
There are other private bodies that, while not as prominent as
the Joint Commission, also
provide health care accreditation services. For example, the
American Osteopathic Associa-
tion (AOA) accredits osteopathic health care facilities. As with
accreditation from the Joint
Commission, an AOA-accredited health services organization is
granted deemed status by the
Centers for Medicare and Medicaid Services for purposes of
reimbursement. Home health

care and community health agencies can receive deemed status
through their own accredita-
tion program called CHAP, or Community Health Accreditation
Program (2013), while many
health plans and networks, such as those provided by large
employers, are accredited by the
National Committee for Quality Assurance (2013).
Accreditation of Educational Institutions
Professional education programs in health care have several
accrediting bodies that survey
the programs to determine that minimal skills and competencies
are being taught. Ever since
an influential 1910 study by Abraham Flexner on the state of
medical education in the United
States, there has been a push for stricter standards (Duffy,
2011). The Flexner Report showed
that American medical education originally consisted of dozens
of colleges with widely dispa-
rate approaches to teaching medicine and standards for judging
academic performance, with
virtually no consistency in the topics and materials covered in
their curricula. Today medical
schools receive oversight from and are accredited by the Liaison
Committee on Medical Edu-

cation, which is a partnership of the Asso-
ciation of American Medical Colleges and
the American Medical Association.
The quality of nursing within health care
organizations is a key determinant of
health care quality and patient safety.
Nursing education is varied, with edu-
cational programs accredited by the
National League for Nursing.
Master’s-level education of health care
administration is accredited by the Com-
mission on Accreditation of Health Care
Management Education, and graduate
programs in public health are accredited
by the Council on Education for Public
Health.
Licensure, Registration, and Credentialing
Attending and graduating from an accredited health care
professional school or college does
not, however, automatically entitle an individual to legally
practice in the United States. In
many cases, health care professionals and other allied workers

must meet certain educational,
training, and competency requirements before they are licensed
to practice by the state. In
Burger/Phanie/SuperStock
Medical schools face strict scrutiny in order to
earn accreditation. This ensures that medical
students are properly trained to the highest
standard.
Patient Safety
some cases, however, there are few requirements before
working in health services organi-
zations. For example, there are currently no federal or state
minimum education or licen-
sure requirements for hospital administrators, though all states
require that nursing facility
administrators be licensed (Longest & Darr, 2008). The purpose

of the various accreditation
processes is to ensure that educational institutions produce
graduates who are qualified and
competent to practice their respective professions.
Whether a health care professional is employed by an
institution, such as a hospital or man-
aged care organization, or works as an independent practitioner,
that professional must,
as noted, be licensed by the state. The particular licensing
process depends on the specific
profession.
After attending an accredited medical school, receiving either
the degree of medical doctor
(MD) or doctor of osteopathy (DO) and completing at least one
year of residency at an accred-
ited program, physicians are required to pass licensing
examinations given by state boards
before being able to legally practice in that state. Other
professionals such as podiatrists,
pharmacists, and nurses must undergo different requirements.
Chiropractors, who tend to
emphasize a different, more mechanical theory of health and
wellness, must also undergo

a series of licensing requirements before they are allowed to
practice on the general public.
Physicians educated outside the United States must pass
additional rigorous examinations
before being eligible for licensure.
Licensure is the power of a state government agency to permit a
person to practice a profes-
sion after the applicant shows that he or she has achieved the
minimum requirements set
forth by the state. In some states, for some health care
professions and occupations, similar
requirements may be called registration. Registered nurses
(RNs), therapists, and dietitians
are examples of professionals who have met the state’s
requirements and have been added to
the state registry that allows these occupations to practice. In
other cases, private organiza-
tions may certify that a professional has achieved minimum
competence levels for his or her
chosen field. A state has the discretion to recognize these
certifications as a requirement
before a professional is allowed to practice within its borders. If
the state chooses to allow
proof of certification as sufficient, then being certified has the

same effect as licensure.
Once licensed to practice, a physician may voluntarily undergo
an additional step known as
credentialing—the process by which states and health care
organizations, based upon dem-
onstration of a professional’s competence, grant that
professional the permission or privilege
to practice within that organization. State medical licenses are
unlimited in scope. The license
allows the physician to practice medicine generally. To ensure
appropriate, safe, and quality
patient care, various forms of voluntary credentialing that go
beyond state licensure have
been devised. Medical specialty boards that certify licensed
physicians as specialists have
significantly grown in number. Today the American Board of
Medical Specialties has granted
membership to 24 different specialty boards in medicine and
surgery, which together certify
125 different specialties and subspecialties (American Board of
Medical Specialties, 2018).
Though it is not legally necessary to obtain board certification
before being allowed to prac-
tice in a particular specialty, the certification usually confers

high prestige and is seen as proof
of expert competency.
Section 6.3Legal Liability of Health Care Organizations and
Professionals
Professional Standards, Guidelines, and Other Policies
Many organizations promulgate codes of conduct and
professional standards to which their
members should adhere in an effort to assure the public of the
quality of their health care. For
example, the American Nurses Association has established
codes of nursing conduct as well
as professional standards for member nurses (American Nurses
Association, 2013). Guide-
lines like these are important not only as public statements of
minimal thresholds of quality,
safety, and ethical care, but also because they help inform the
thresholds for legal negligence
and help in malpractice or professional liability contexts.

Failure to comply with professional
standards and guidelines for safe practice may stand as
compelling evidence of a health care
professional’s or health care organization’s breach of duty.
6.3 Legal Liability of Health Care Organizations
and Professionals
Legal liability refers to the legal duties
and responsibilities that are owed to
another. Being liable for something means
that adherence to a legal duty is required.
It also implies that nonadherence to a
legal responsibility exposes the person to
a risk of successful adverse legal action.
Legal liability is yet another method by
which society attempts to ensure the qual-
ity and safety of health care by compelling
health care professionals to meet or sur-
pass expected standards of practice and
competence in their fields of expertise.
A Tort Law Primer
In American jurisprudence, tort law con-
cerns liability for breach of the legal duty

to refrain from harming others. Tort law
also provides disincentives for future
risky or negligent conduct by awarding
damages for conduct that falls below the
standard of care. A tort refers to a wrong
or harm toward another person that
breaches society’s expectations for civil
interpersonal conduct. For example, if a
physician fails to pay close enough atten-
tion and operates on the patient’s right arm when other, prudent
physicians would have
known to operate on the left arm, that physician has committed
the tort of negligence. (Figure
6.2 shows the number of medical errors in the United States
from 2004 to 2010.)
Cusp/SuperStock
Legal liability is another method for ensuring
high-quality health care by holding providers
legally accountable for their performance.

Professionals
Figure 6.2: Patient outcome by type of “never” event, 2004–
2010
The Institute of Medicine estimates that an average of 98,000
people die each year in the United
States from some type of medical error. This chart provides a
breakdown of the type of injury or
death that resulted from physician errors.
Source: Reprinted by permission of GeoBeats Productions
Law in Focus: The Requirements of a Negligence
Claim in Law
The law that governs when a medical professional makes a
mistake requires that health
care professionals be reasonably careful when treating patients.
This reasonable expecta-
tion is termed the standard of care, that is, the minimum
conduct for which health care
professionals are responsible. In medicine, things often go

wrong, and bad results occur.
This does not necessarily mean that there was negligence. As
long as the health care prac-
titioner was abiding by the standard of care, then a patient has
not been legally wronged.
Although the patient may have been unintentionally harmed in
the process, he or she will
not be successful in a court case for damages. If, on the other
hand, the patient was harmed
due to the failure of the health care professional to abide by the
appropriate standard of
care, then the patient has been wronged as well as harmed, and
tort law can afford a legal
remedy. Another name for care that unintentionally falls below
the minimum requirements
of the standard of care is negligence.

Professionals
Charitable Immunity
Hospitals were initially charitable (either religiously affiliated
or nonsectarian) institutions
that were largely supported by donated monetary and human
resources (Showalter, 2012).
Today many hospitals and health care systems retain religious
or other charitable connec-
tions, but few people would confuse the charitable hospitals of
today with the crude alms-
houses of long ago. Nonetheless, for much of modern history,
hospitals retained immunity
from tort liability based on their charitable status. The policy
rationale for charitable immu-
nity was to keep these organizations performing their valuable
function in society. It was also
understood for many years that people who benefited from
charity implicitly waived their
rights to sue in return for free service (Showalter, 2012).
In the latter half of the 20th century, however, the change in
public sentiment and societal
circumstances under which health care organizations operated—
even those that were not

for profit—made the rationale for charitable immunity of health
care organizations no longer
compelling. Immunity also meant that there was no deterrent for
negligent or reckless con-
duct on the part of health care workers or institutions. Although
some government or public
hospitals in a few jurisdictions continue to enjoy a narrower
type of immunity from liability
based on the doctrine of sovereign immunity, the injustice of
wrongfully harmed but uncom-
pensated patients eventually pushed every state to dissolve or
limit charitable immunity for
health care organizations.
Law in Focus: The Requirements of a Negligence
Claim in Law (continued)
For a civil lawsuit based on a claim of negligence, the plaintiff
has the burden to prove all
four of the following:
1. The health care professional must have a legal duty to uphold
the standard of care
for this particular patient. This duty means that a legal
relationship exists. This usu-

ally occurs whenever a patient presents for health care and the
health care institu-
tion or professional admits the patient. A doctor–patient
relationship may be ongo-
ing (primary care), time bound (emergency care), or issue bound
(specialty care).
Even if the harm does not occur until after the provider–patient
relationship ends,
if it can be shown to be the direct consequence of the care
received, courts will hold
that since the duty existed at the time of treatment, the duty
requirement is fulfilled
for purposes of a negligence claim.
2. The plaintiff must show that the health care professional
failed to uphold the mini-
mum standard of care relevant to the case. For instance, failure
to ask the patient about
known drug allergies prior to prescribing a new medication
could constitute a breach of
legal duty.
3. The plaintiff must show that they were harmed.
4. The plaintiff must also show that the harm was proximately
or directly caused by

the breach of legal duty.
Professionals
Corporate Liability
Hospitals and other health care organizations are legally liable
for failing to exercise the rea-
sonable duty of care and concern for the rights, welfare, and
safety of their patients. Through
the legal doctrine of corporate liability, health care
organizations can be found negligent
in carrying out their responsibilities. For many years hospitals
were seen as workshops in
which independent health care physicians practiced. It was
beneficial to hospitals to cultivate
this fiction, since it had proved successful in relieving hospitals
from liability, as we will see
below. Today, hospitals and their administrators do not see their

role as simply furnishing
the physical accommodations for professionals to do
independent work—and neither should
the courts. An entity that presents itself as a health care
organization that provides the com-
munity with health care services has ethical and legal duties to
provide those services and
facilities safely and not negligently.
The rationale for the corporate liability doctrine is exemplified
in the 1957 landmark case of
Bing v. Thunig, in which the court found:
The conception that the hospital does not undertake to treat the
patient,
does not undertake to act through its doctors and nurses, but
undertakes
instead simply to procure them to act upon their own
responsibility no longer
reflects the fact. Present-day hospitals, as their matter of
operation plainly
demonstrates, do far more than furnish facilities for treatment.
They regularly
employ on a salary basis a large staff of physicians, nurses and
interns, as well

as administrative and manual workers, and they charge patients
for medical
care and treatment, collecting for such services, if necessary, by
legal action.
Certainly, the person who avails himself of “hospital facilities”
expects that the
hospital will attempt to cure him, not that its nurses or other
employees will
act on their own responsibility.
The doctrine of corporate liability is therefore used to find
health care organizations liable
whenever they recklessly or negligently fail to uphold minimum
standards of care, such as
not having the appropriate supplies, equipment, or personnel to
properly staff a division or
department. To illustrate further, if background checks are the
standard of care, a long-term-
care facility that fails to do a background check when hiring a
health care worker with a his-
tory of violent crime who subsequently assaults and injures a
patient is liable for such an
oversight.
Vicarious Liability

Vicarious liability is the principle that an organization is
ultimately liable for the negligent
acts and omissions of its employees or supervisees. Under
vicarious liability, an employer or
superior is liable regardless of whether he or she was personally
or directly at fault. Vicarious
liability is based on the principle that organizations or
principals ought to be held responsible
for the acts of employees or supervisees who are acting within
the scope of their employment.
The expectation is that when an organization finds itself
exposed to liability for the conduct of
its employees, it will more carefully train employees to ensure
patient safety.
As an ethical precept and as public policy, the principle of
vicarious liability is a defensible
legal doctrine. The negligent behavior of one health care worker
can cause great harm. If
the negligent party were personally forced to pay, then that one
person might be financially

Professionals
ruined (which may be an excessive punishment), and the
resultant recompense for the injured
party may be insufficient. Employers and health care
organizations have the financial means
to adequately cover their claims through insurance and are
better equipped to compensate
those who may have been harmed by their supervised
employees.
Not everyone working within the physical confines of a health
care institution is an employee
of that institution. Physicians in particular are independent
practitioners who contract with
the organization. Since vicarious liability rests on the
requirement of an employment or
supervisory relationship, independent contractors who have
control over their own work are
generally held solely responsible for their own actions.
This is one of the main reasons that most hospitals historically

have related to physicians
as independent contractors through the process of privileging.
Under these circumstances,
vicarious liability could not be applied, which resulted in
lowered risk for hospitals because
they could not be found vicariously liable for the negligence of
independent contractors.
Without an employment relationship, hospitals could effectively
wash their hands of doctors’
negligent conduct, even if the institution knew of such conduct.
Since these risk-lowering arrangements tend to thwart the
objectives of the tort system (com-
pensating injured victims and deterring undesired conduct),
courts have grown increasingly
impatient with the avoidance of responsibility on the part of
some health care institutions.
Today, courts are more willing to discover employment-like
relationships even where only
independent contractor language exists. Moreover, more
physicians and other health care
professionals who were formerly kept at arm’s length as
independent contractors are now
likely to have employment contracts with the institutions where
they work.

Even institutions that continue to operate through independent
contractors, however, may
be held vicariously liable for their actions. This is because, in
an increasing number of cases,
plaintiffs can show that they reasonably believed that the health
care professional was acting
as an agent or employee of the health care institution and relied
on that belief in seeking care.
This is known as apparent agency and may make the health care
organization liable despite
the fact that the health care worker whose negligence was the
proximate cause of the harm
was seen by the organization to be an independent contractor.
Tort Reform
The use of tort law to ensure the quality and safety of health
care is a divisive public policy
issue. Although there is general agreement that tort law can be
an effective means to ensure
compliance with minimal standards, many question whether it
creates effective deterrence
to bad behavior and at what point it starts to become an
impediment to effective health care.

The problem lies partly in the fact that, since tort law relies on
awarding monetary remedies
to those who have been harmed, unscrupulous parties may be
tempted to sue for the possible
financial rewards, even when they have received good health
care. There is the potential for
nonmeritorious claims (which have some basis, but the plaintiff
cannot prove all the elements
necessary for recovery) or even frivolous lawsuits (which have
no basis at all). For example,
consider the McDonald’s restaurant coffee case, Liebeck v.
McDonald’s Restaurants (1995). In
this case, a woman who spilled hot McDonald’s coffee on her
lap sued the fast food company
after suffering serious burns. A jury awarded her $2.86 million,
which included $160,000 to
Professionals

cover her medical expenses and compensatory damages, with
the remaining $2.7 million as
punitive damages against McDonald’s. The case was an
overnight media sensation; late-night
talk show hosts parodied the frivolity of the case and the
astronomical damages awarded
by the jury (Cain, 2007). It became a flashpoint in the already
contentious debate over tort
reform in the United States. Politicians cited the case as an
example of a justice system gone
awry, in which the fear of crippling financial loss might quell
commercial, industrial, and pro-
fessional progress and ambition. The McDonald’s coffee case
became the impetus for pass-
ing tort law changes in some states. Changes in tort law impact
health care as well as other
sectors.
The Hot Coffee Case
A closer look at the Liebeck case reveals a less egregious, and
perhaps even a just, result (Cain,
2007; Greenlee, 1997; Gerlin, 1994). On a winter morning in
1992, 79-year-old Stella Liebeck,
while in the passenger seat of a parked car, attempted to remove
the lid from her 49-cent

cup of McDonald’s coffee to add cream and sugar. She placed
the cup between her knees,
and while she tried to remove the lid, the entire cup of coffee
spilled directly into her lap.
The burns were so intense that her grandson, who had been
driving the car, rushed her to
the emergency room of a local hospital, where she was
diagnosed with third-degree burns
to her thighs, groin, and buttocks—some of which destroyed her
tissues to the bone. She
also received less severe burns and scalds over a greater portion
of her body. Liebeck had to
undergo acute medical treatment, including skin grafts, as well
as two years of subsequent
medical treatment for the burns, from which she continued to
suffer (Cain, 2007).
Following the incident, her family approached McDonald’s
Restaurants to alert them that the
coffee was much too hot. They later asked McDonald’s for
$20,000—enough to cover her past
and future medical expenses related to the incident, as well as
her loss of income. Instead, the
mega-corporation offered her $800 to settle any claim. After
retaining counsel, Liebeck sued

McDonald’s.
During the trial, it became apparent that not only had
McDonald’s previously been aware that
its coffee would cause third-degree burns in 2 to 7 seconds, it
knew that many people had
already suffered third-degree burns because of the coffee
temperature. In fact, the litigation
discovery process revealed that, in the previous decade, more
than 700 reports of serious
burns had been received by the fast food giant, and yet
McDonald’s had made the deliberate
choice not to change its policy on coffee temperature
(Fleischer-Black, 2004). The industry
standard for coffee temperature was about 20 degrees lower
than McDonald’s official cof-
fee temperature policy. Coffee at the lower temperature could
produce third-degree burns
in approximately 12 to 15 seconds, vastly increasing the time
that people had to remove the
coffee from their skin before injury resulted. Why then did
McDonald’s choose not to make
the adjustment that might save many hundreds of people from
grievous injury?

The answer to this question remains a matter of interpretation,
but internal corporate docu-
ments corroborated what some policy makers, economists, and
organizational psychologists
fear is a corporate temptation in these types of situations.
Enjoying the sizable profits that
come from having an in-demand product, a business will be
very reluctant to change the
product in any way that may affect its profitability. Many
commuters, for example, may not
drink their coffee until several minutes after the initial
purchase, and it stands to reason that
Professionals
the hotter the initial temperature, the “fresher” the coffee will
be when finally consumed. Tort
law is designed to overcome this economic reluctance (which
can translate into unethical and

even illegal behavior) by making the repercussions too great
(both in expense and in loss of
public trust) for the company that refuses to make its products
safe.
However, this means that the financial disincentives provided
by tort law must actually effec-
tively deter the bad behavior. This was not the case with
McDonald’s. Despite hundreds of
past coffee burn allegations, some of which had resulted in
settlements or judgments of more
than $500,000 (Gerlin, 1994), the McDonald’s quality control
manager testified that the num-
ber of injuries and costs to settle these cases out of court were
insufficient to cause the com-
pany to seriously reevaluate its practices (Nader & Smith,
1996). When economic damages
are insufficient to cause businesses to change potentially bad
behavior, the threat of tort suits
are ineffective. Therefore, it is essential that damages be
substantial enough to serve as a
disincentive to the potentially negligent party. For a company as
large as McDonald’s, which
at that time made more than $1 million every day in profit on
coffee sales alone, financial

damages must be large enough for the company to take notice.
The jury felt that the punitive
damages were not excessive and might be enough to get the
attention of McDonald’s (though
economists and business psychologists might argue that this
sum, amounting to no more than
two days’ worth of McDonald’s coffee sales, might still be too
low to be a real disincentive).
The media and public outcry was immediate and vehement,
however, and pressured the trial
court to reduce the punitive award to $480,000, although the
judge characterized McDonald’s
conduct as reckless, callous, and willful.
Return to Tort Reform
It is important to distinguish the McDonald’s case, for which a
plausible argument might be
made in favor of awarding punitive damages in addition to
compensatory damages, from the
typical medical malpractice lawsuit. In the latter, ordinarily
there is no viable claim of reck-
less or willful misconduct; instead, almost all professional
malpractice cases are predicated
on the theory of negligence, or unintentional deviation from the
standard of care owed to the

patient. Thus, the awarding of punitive damages (which are
intended to punish the wrong-
doer for intentional or reckless and wanton conduct) is
exceedingly rare in the malpractice
context.
Nonetheless, the fallout from the McDonald’s case has
implications for health care delivery.
Some states have amended their tort laws to make it more
difficult to recover damages, as
well as placed caps on the total amount of damages possible.
Some states made it difficult for
patients who had been harmed to be successful in a lawsuit and
reduced the chances of being
awarded damages that might be sufficient to change bad habits,
not to mention enough to
cover medical expenses, lost wages, and reduced quality of life.
Despite the tort reforms that various states have undergone
since the 1980s, medical malprac-
tice insurance premiums continue to be a significant
expenditure by health care practitioners.
Expenses related to defensive medicine and risk management by
health care organizations
continue to escalate. Because of this, health care organizations

spend inordinate amounts
of time, resources, and money to reduce their risk profile and
will often automatically pre-
sume an adversarial stance whenever an error, or even a bad
outcome, occurs (Elliott, 2010).
(Figure 6.3 shows the rising costs of medical malpractice in the
United States.)
Professionals
Figure 6.3: Medical malpractice costs, 1975–2009
The litigation expenses for medical malpractice in the United
States cost upward of $30.4 billion in
2009, a significant increase over the $1.16 billion it cost in
1975. Is tort law allowing people to sue
more readily, or is medical malpractice on the rise?
Source: Copyright ©2011 Towers Watson. Used with

permission.
This defensive tendency is exacerbated by the knowledge that,
since medical malpractice law-
suits can be expensive and lengthy cases to defend, insurance
companies sometimes prefer to
offer the plaintiff a sum of money in return for dropping the
lawsuit—even when the plain-
tiff ’s claim seems doubtful or frivolous. The propensity of
malpractice insurers and health
care organizations to settle disputes out of court also prompts
physicians to practice medi-
cine “defensively,” which should seldom be confused with
practicing medicine appropriately.
Defensive Medicine
Defensive medicine, or practicing medicine with the goal of
reducing the risk of liability, may
represent an ethical way of achieving the ultimate ends of
medicine. However, it becomes eth-
ically and legally problematic when reducing the risk of being
sued increases certain bad or
inappropriate medical practices that can result in compromised
patient care and, ironically,
the heightened risk of being sued (Manner, 2007). As one

example, in many health care orga-
nizations and medical cultures, it is explicit or implicit policy
that once an error has occurred
that may have compromised a patient’s care, health care
workers and professionals should
immediately contact legal counsel or risk management,
beginning an adversarial stance and
putting up a wall of silence between the health care team and
the patient regarding the error
(Wojcieszak, Saxton, & Finkelstein, 2010). In turn, patients,
who often simply want (and
deserve) explanations and honest accountability, may feel that
health care workers detach
Chapter Highlights
their concern, avoid them, and become suddenly silent or
noncommunicative. In many cases,
patients who might otherwise never sue their doctor or hospital
feel that a lawsuit is the only

way they can understand what happened. Often, patients want
not only explanations but for
health care organizations and professionals to take
responsibility, admit guilt, apologize, and
assure patients that steps will be taken to minimize a
recurrence. However, in order to reduce
the risk of liability, many medical cultures and hospital policies
discourage health care work-
ers from apologizing or taking responsibility even though
numerous states have laws that
specifically exclude apologies from being introduced as
evidence of admission of guilt in a
liability suit (Wei, 2007).
Practicing medicine with an eye toward evading legal liability
instead of furthering the ends
of health care can undermine good medical care in other ways
as well. This type of defensive
medicine will often result in increased waste, costly over-
testing, and potentially harmful and
unnecessary procedures (Manner, 2007). This is because “doing
more” is often confused with
“better care.” Doctors may also feel that acquiescing to patient
demands for proactive treat-
ment is more likely to be perceived as true concern for a

patient’s welfare, which in turn will
reduce the likelihood of being sued, even if that means ordering
tests and procedures that
are unnecessary. Not only is this an ethical problem because of
the way that excessive costs
hurt everyone (as we will see in the next few chapters), it
undermines the safety and quality
of care that patients receive as a result. This occurs for several
reasons. Due to the uncertain
nature of most clinical tests, their increased use invites the
possibility of unneeded treatment.
Since unnecessary procedures and interventions hold little hope
of medical benefit, the only
purpose they serve for patients is to increase the risk of harm—
something that all treatments
and procedures involve. A heightened risk of harm, though
certainly not the intended conse-
quence of practicing defensive medicine, is likely to result in a
heightened risk for a lawsuit
(Healey, Kopen, & Smith, 2011).
Rather, what is needed is a means of achieving the benefits of
tort law as an instrument of
redress and justice for those who have been harmed. Also
needed is a way to incentivize

appropriate practices in health care and minimize the harms that
can come from the sys-
tem’s abuse.
Chapter Highlights
• Medical mistakes pose a serious risk to patient safety in health
care settings.
• There are important ethical and legal reasons to attempt to
improve patient safety
while minimizing the harm that can come from policies that may
be in themselves
harmful or unjustly retributive.
• Tort law may serve the functions of compensating injured
victims of medical negli-
gence and deterring future instances of substandard medical
performance.
• The principles of preventive ethics (namely, the methods and
processes by which
we try to anticipate ethical and legal dilemmas and keep them
from developing in
the first place) encompass methods such as federal and state
oversight and regula-

tion of health care environments, private and professional
review and accreditation
standards, professional guidelines and standards of care, health
care educational
accreditation and review, licensure examinations, and
credentialing requirements
for health care workers.
Chapter Highlights
Case Study: Darling v. Charleston Community Memorial
Hospital
The following is a classic landmark case that
deals with not only the legal liability of doc-
tors and hospital staff but also what a health
care organization’s liability should be when
it shares the blame for the harm caused to
patients. (Much of the background informa-
tion on this case came from Johnson, 2009.)

Background
Pat Darling was a bright, athletic freshman at
Eastern Illinois University with plans of one
day becoming a teacher and coach. In the fall
of 1960, Darling was playing defensive left
halfback for the university when a twisting
block from an opposing player caused a spi-
ral fracture that broke his leg. Darling was
rushed to the nearby Charleston Community
Memorial Hospital (CCMH). At CCMH, Darling
was seen by Dr. John Alexander, an internist working in the
emergency department, who
gave Darling the customary care by setting his bones and fitting
him for a cast that started
at his hip and opened at his toe.
That night, Darling experienced continuous intense pain, a
discoloration of his toes, and
swelling in his foot. In response, Alexander partially cut
Darling’s cast; however, the pain
and discoloration continued. The nurses noted that Darling was
in constant pain that did
not subside. By the third day, Alexander decided to split the

cast and re-tape the leg. While
the doctor cut the cast, Darling exclaimed that the saw was also
cutting him. Alexander dis-
missed Darling’s claim, but blood on his pillow the next
morning confirmed that his leg was
in fact cut. In addition to the swelling, discoloration, and pain,
a putrid odor emanated from
Darling’s leg, indicating an infection.
Alexander regularly visited Darling, and the nursing staff
sought to comfort him; however,
Alexander never sought a consultation with an orthopedic
surgeon, nor did the nurses
report Darling’s deteriorating case to an outside physician or
the administration.
After two weeks, Darling’s parents moved him to Barnes Jewish
Hospital in nearby St. Louis,
Missouri, where Dr. Fred Reynolds, the chair of orthopedic
surgery at Washington Univer-
sity, found that the circulation to the muscles in Darling’s leg
had been restricted, leading
to necrosis. After multiple muscle-stripping surgeries, it was
decided that the leg from the
knee down must be amputated in order to save Darling’s life.

Trial
The trial began in October 1962. Before the trial, Alexander
settled with the Darling family
for $40,000, but Darling’s lawyers continued to pursue a case
against CCMH for negligence.
While Darling was a sympathetic claimant, his lawyers still had
a momentous task. Up until
this case, hospitals had been considered to have very limited
duties for standards of patient
RAMARE/BSIP/SuperStock
Darling v. Charleston Community Memorial
Hospital was a landmark case involving a
doctor’s improper application and removal
of a leg cast on college football player Pat
Darling.

Chapter Highlights
Critical Thinking and Discussion Questions
1. Explain the importance of corporate liability for protecting
both patients and health
care organizations.
2. How important is federal oversight in ensuring patient
safety? Based on the number
of medical mistakes per year, do you believe existing
regulations are adequate? If
not, how could they be improved?
3. How did Liebeck v. McDonald’s Restaurants precipitate tort
reform? Name some
other lasting effects of the “hot coffee” case.
Key Terms
apparent agency The appearance to an
outsider (e.g., a patient) that a health care
professional is acting as an agent of a health
care institution, when in fact the health care
professional is acting as an independent

contractor for the institution.
certifications Processes documenting
competence in a skill or field.
Case Study: Darling v. Charleston Community Memorial
Hospital (continued)
care, which centered on maintaining physical facilities.
Additionally, in past cases, only the
doctor was seen as being responsible and liable for patient care.
Darling’s lawyers argued
that the hospital had direct liability for patient care as soon as
patients entered the facility.
They argued that CCMH breached a duty by allowing
Alexander, an internist, to perform
procedures for which he lacked the requisite skills and training
and by failing to adequately
train and supervise nurses, who failed to report the symptoms of
Darling’s leg.
Darling’s lawyers produced evidence of the required standard of
care, including the Joint
Commission’s accreditation standards, the Illinois Hospital
Licensing Act’s rule, and CCMH’s

own bylaws. CCMH’s lawyers, on the other hand, argued that
even if the hospital owed the
patient a direct duty, the standard of care it owed should be
based on the traditional “local-
ity” rule—that is, hospitals are not judged by external national
standards but against local
hospital customs. CCMH’s lawyers argued that it would have
been improper for the hospital
to question or interfere with Alexander’s treatment of Darling,
whereas Darling’s lawyers
asserted that it was the hospital’s duty to ensure quality care
even if that meant hindering
Alexander’s freedom to make treatment decisions for his
patient. The jury found for Dar-
ling and awarded him a substantial sum. The case was
eventually appealed to the Illinois
Supreme Court, which affirmed the trial court’s judgment for
Darling.
The Darling opinion upset several precedents (though these had
already begun to erode
before this case). First, charitable immunity no longer applied
to private hospitals. Sec-
ond, the idea that hospitals have a limited (i.e., custodial) duty
to patients was rejected and

replaced with the finding that hospitals have a direct legal duty
to patients to ensure qual-
ity care. Third, the use of external guidelines and internal
bylaws to establish a standard of
care for hospitals was approved. The court also held that there
was adequate evidence to
support the jury’s verdict that CCMH’s nurses did not recognize
the gangrene and report it
to an outside physician or administrator and that CCMH did not
require Alexander to con-
sult with a specialist, even though he was practicing outside of
his general area of expertise.
Chapter Highlights
corporate liability The legal doctrine that
health care organizations, as corporations,
are responsible for exercising reasonable
care for the rights, welfare, and safety of
their patients.

credentialing The process by which states
and health care organizations, based upon
demonstration of a professional’s compe-
tence, grant that professional the permis-
sion or privilege to practice within that
organization.
defensive medicine The practice of medi-
cine with the goal of reducing liability.
iatrogenic Relating to inadvertent illness
or injury incurred in the course of receiving
health care.
legal liability The legal duties and respon-
sibilities that are owed to another.
licensure State permission given to a
professional that allows the professional
to practice his or her profession in that
jurisdiction.
morbidity Refers to an illness, disease, or
impairment.

mortality Refers to death.
negligence The failure to meet the mini-
mum requirements of care.
standard of care The duty of care that a
health care professional owes to a patient,
as determined by the reasonably foresee-
able risk of harm.
tort A wrong or harm toward another per-
son that breaches society’s expectations for
civil interpersonal conduct.
vicarious liability The legal doctrine that
holds an employer or supervisor liable
for the negligent acts or omissions of an
employee or supervisee, even if the supe-
rior was not personally at fault.

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