UMGC Accepting Responsibility for Committing Errors Questions

Reputation

How should providers accept responsibility for committing errors in making ethical decisions at the expense of the reputation of the organization?

Innovation Recommendation

Make an innovative recommendation of how to modify or change the proposed recommendation to make it stronger. This recommendation for improvement should consider innovative solutions.   
Chapter 3
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Medical Errors:
Paradise Hills Medical Center
Case Stu d y
Paradise Hills Medical Center was a 500-bed teaching hospital in a major metropolitan area of the South. It was known throughout a tristate area for its comprehensive oncology program and served as a regional referral center for thousands of
patients suffering from various forms of malignant disease.
Paradise Hills was affiliated with a major university and had residency programs in internal medicine, surgery, pediatrics, obstetrics and gynecology, psychiatry, radiology, and pathology—all fully accredited by the Accreditation Council for
Graduate Medical Education. In addition, Paradise Hills had an oncology fellowship
program, a university-affiliated nursing program, and training programs for radiology technicians and medical technologists. All of these teaching programs were
highly regarded and attracted students from across the nation.
Paradise Hills enjoyed an enviable reputation. It was respected for its high-­
quality care; its state-of-the-art technology; and its competent, caring staff.
Although Paradise Hills was located in a highly competitive healthcare community,
it boasted a strong market share for its service area. Its patients also provided significant referrals to the surgery, pediatrics, and radiology programs.
Paradise Hills was a financially sound institution with equally strong leadership.
Its past successes could be attributed in large part to its aggressive, visionary CEO
and his exceptionally competent management staff.
But all was not as well as it seemed at Paradise Hills. Although the oncology
program still enjoyed a healthy market share of 75 percent, it had been slowly
and steadily declining from a peak of 82 percent two years earlier. In addition,
the p
­ rogram’s medical staff was aging, and some of its highest-admitting physicians were contemplating retirement. The oncology fellowship program had been
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established a few years previously to address this situation, but unfortunately the
graduates of this program had so far elected not to stay in the community. Of most
concern to the CEO and his staff was the fact that the hospital’s primary competitor
had recently recruited a highly credentialed oncology medical group practice from
the Northeast and had committed enormous resources to strengthening its own
struggling cancer care program.
The previous week, Paradise Hills’s board of trustees had held its monthly
meeting, with a fairly routine agenda. However, during review of a standard quality
assurance report, one of the trustees inquired about a section of the report indicating that 22 oncology patients had received radiation therapy dosages in excess of
what had been prescribed for them. It was explained that the errors had occurred
because of a flaw in the calibration of the linear accelerator and that the medical
physicist responsible for the errors had been asked to resign his position. Another
trustee then asked if the patients who had received the excessive radiation had
been told about the errors. The CEO responded that it was the responsibility of the
medical staff to address this issue, and they had decided not to inform the patients
about the errors. The board did not agree that the medical staff were solely responsible for informing the patients about the errors and requested that the administrative staff review both the hospital’s ethical responsibility to these patients and its
liability related to the incident, and report back to the board within two weeks.
The CEO and his management staff responsible for the radiology department
and the oncology program met with the medical staff department chairs for internal
medicine and radiology, the program medical directors for oncology and radiation
therapy, and the attending oncologists. The CEO related the board’s discussion
about the errors and the board’s request that the actions taken be reviewed, specifically the decision not to inform the affected patients.
All of the physicians agreed that the adverse effects of the accidental radiation
overdose on the patients were unknown. The oncologists argued that the patients
should not be told of the incident, asserting that cancer patients did not want or
need any more bad news. “Let’s face it—these patients are terminal,” they said.
“Informing them about this error will only confuse them and destroy their faith and
trust in their physicians and in the hospital.” Furthermore, they claimed, informing the patients of the errors could unnecessarily frighten them to the extent that
they might refuse further treatment, which would be even more detrimental to
them. Besides, the physicians argued, advising the patients of potential ill effects
just might induce those symptoms through suggestion or excessive worry. Every
procedure has its risks, the radiology department chair insisted, and these patients
signed an informed consent.
Physicians know what is best for their patients, the attending oncologists
maintained, and they would monitor the patients in question for any ill effects. The
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department chair for internal medicine was of the opinion that the incident was
clearly a patient–physician relationship responsibility and not the business of the
hospital. Besides, the radiology chair added, informing the patients would “just be
asking for malpractice litigation.”
The medical director for the oncology program then suggested that the board of
trustees and the management staff “think long and hard” about the public relations
effect that disclosing the incident would have on the oncology program. “Do you
really think patients will want to come to Paradise Hills if they think we’re incompetent?” he asked.
The CEO conceded that he supported the position of the medical staff in this
matter and that he, too, was concerned about preserving the image of the oncology
program. But, he said, his hands were tied because the board clearly considered
this an ethical issue that would have to be referred to the hospital’s ethics committee for its opinion.
The physicians noted that if indeed the ethics committee subsequently recommended that the patients be informed, then realistically that responsibility would
rest with the patients’ primary care physicians and not with any of them.
Eth ics Issu es
Truth telling: Is there a difference between lying to a patient and withholding
the truth? Does it matter to the patient whether the act is one of omission or
­commission?
Justice and fairness: Is it fair to these patients to withhold information about their
clinical treatment and any potential risks inherent in the accidental overdose?
A patient’s right to know: Do these patients have a right to know about this incident? Do these patients have a right to know so that they may make informed
therapeutic choices? Can not informing the patients affected by this radiation
overdose be reconciled with the patients’ bill of rights?
Adherence to the organization’s mission statement, ethical standards, and values
statement: Are the actions being considered in this case consistent with the hos-
pital’s mission statement, ethical standards, and values statement?
Adherence to professional codes of ethical conduct: Are the actions being consid-
ered in this case consistent with the codes of ethical conduct promulgated by the
professional organizations and associations representing physicians, healthcare
executives, and hospitals?
Discrimination against a class of patients: Does labeling these patients as “termi-
nal” invalidate their self-determination? Does it limit their ability to p
­ articipate
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in their choice of treatment options? Does discrimination against terminal
patients give tacit permission to discriminate against other diverse groups, such
as the aged, immigrants, or LGBTQ people?
Management’s role and responsibility: What are the role and responsibility of
hospital management in this matter? What are the role and responsibility of the
hospital CEO specifically?
Legal implications: What are the legal implications of the actions being con-
sidered for the hospital? For the physicians involved? Does withholding information about this medical treatment and its potential risks from the patients
involved constitute medical malpractice? In the view of the legal system, is this
action indeed fraud? Has the hospital’s management considered the liability
exposure for fraud that is not covered under medical malpractice insurance?
Other legal aspects to be considered relate to specific liability and employment issues. Who employs and supervises the medical physicist? Who pays
the medical physicist, and who asked him to resign? Is the medical director
for radiation oncology, who typically prescribes radiation therapy dosages, an
employee of the hospital or an independent contractor? If the medical director is
a contract physician, does the contract stipulate that he hires and pays the medical physicist? Should it? Is the medical director responsible for the actions of
the medical physicist whether the medical physicist is employed by the medical
director or not? Finally, who owns the linear accelerator used in this case?
Organizational implications: How will the actions being considered in this case
affect the oncology program? The hospital as a whole? The hospital staff?
Ethical decision-making framework: Can the actions being considered in this case
be justified within an acceptable ethical decision-making framework?
Discu ss ion
Truth Telling, and Justice and Fairness
The fundamental issue in this case seems to be one of truth telling. Is it not a basic
tenet of all ethical relationships that individuals and organizations tell the truth?
Is it not the “right” thing to do?
The physicians in this case have argued that telling the truth would cause more
harm than good—that not sharing this incident with their patients is, in fact, in
their patients’ best interest. This position, of course, assumes that the patients will
never find out about the incident or that they will die without the incident ever
coming to light. From a practical standpoint, this eventuality may indeed be the
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case. But on closer examination, is this scenario likely? Consider the number of
healthcare workers who interact with a patient on any given day and have access
to the patient’s medical record. In a teaching hospital, that number is likely to be
higher. The prescribed radiation therapy and the received radiation therapy are a
matter of medical record. Incident reports and quality assurance reports are also
a matter of record. Is it realistic to believe that staff will not have questions about
the incident and, worst-case scenario, inadvertently discuss it with the affected
patient? Given the great number of staff, physicians, and trustees who are privy to
this information, is maintaining a “conspiracy of silence” even possible? Is it right
for the hospital to attempt to cover up the error?
In the event that the patients or their families find out about the incident after
the fact, what then? What effect will this knowledge have on their opinions of the
physicians and the hospital?
Clearly, human relationships are built on the communication of information.
If the information shared is not truthful, there can be no trust. Unfortunately, not
telling the entire truth in a situation usually means additional shading of the truth
or outright lying when questions arise. An individual or institution that betrays
the trust on which relationships are built is no longer credible. This betrayal of
trust can be especially problematic in healthcare, where patient compliance and
positive health outcomes depend on patients’ trust in their healthcare providers.
In the Paradise Hills case, lying or withholding the truth carries enormous risk
for undermining the image of the physicians and the hospital. If the incident is discovered by the patients or their families, the physicians and the hospital could be
accused of attempting to cover up the incident, which could prove disastrous both
in the judgment of the community and in a court of law. Recent political scandals
are a tragic reminder that the public will not quietly stand for deceitfulness.
However, the intent in withholding information could arguably be to protect
the patients from unnecessary stress and anxiety, not unlike the “white lies” used
to spare someone’s feelings in everyday life. Is this a fair comparison? Using the
Golden Rule as a guide, if you or a loved one were the patient, would you want to
know the truth about the incident? Or would you wish to be spared the anxiety?
In the assessment of Elisabeth Kübler-Ross (1969, 32), the psychiatrist
renowned for her theory of the five stages of grief, “the question should not be
stated, ‘Do I tell my patient?’ but should be rephrased as, ‘How do I share this
knowledge with my patient?’” Kübler-Ross believed that “the way in which the bad
news is communicated is . . . an important factor which is often underestimated
and which should be given more emphasis in the teaching of medical students and
supervision of young physicians.” Does her assessment apply in this case?
Much in the literature supports the notion that what matters is not so much
what is said as how it is said and in what context. Medical information should
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25
be presented by a physician with whom the patient has a trust relationship, and
nursing staff should be in attendance so that they can prompt the patient to ask
questions of the doctor before she leaves or answer such questions after she has
gone. While this solicitude may seem like a small thing to do, in today’s rushed
environment nurses may not be expected or have time to make rounds with physicians. To further compound the situation, in teaching hospitals the patient may
feel overwhelmed by a large entourage of house staff, and in nonteaching hospitals
a hospitalist whom the patient does not know well may be designated to inform
the patient about the medical error. Some might suggest that the risk manager or
hospital attorney should be in attendance when a patient is informed about an
error. This consideration must be weighed against any alarm or apprehension their
presence may generate. When multiple patients need to be informed individually
about an error, using scripted information—or at least talking points—may be
wise to ensure all patients receive the same information.
A relevant study by Iezzoni and colleagues (2012) presented some startling
revelations about physician attitudes:
Approximately one-third of physicians did not completely agree with the need to
disclose serious medical errors to patients, almost one-fifth did not completely agree
that physicians should never tell a patient something untrue, and nearly two-fifths of
physicians did not completely agree that they should disclose their financial relationships with drug and device companies to patients. Just over one-tenth said they had
told patients something untrue in the previous year.
The researchers concluded:
Our findings raise concerns that some patients might not receive complete and accurate information from their physicians, and doubts about whether patient-centered
care is broadly possible without more widespread physician endorsement of the core
communication principles of openness and honesty with patients.
The study suggests that healthcare professionals could use more education
and training about truth telling in patient-centered care. Patients need information and to have all of their questions answered in a straightforward, concerned
manner to be able to participate appropriately in their treatment options and
to comply with medical instructions. The increasing diversity of both patient
populations and healthcare professionals further complicates communications.
For more on managing diversity and the ethical implications it presents, see
chapter 17.
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A Patient’s Right to Know
Do the patients in the Paradise Hills case have a right to know about the error and
how it may potentially affect them? In an effort to encourage patients to become
active participants in their care, the American Hospital Association (AHA 2003)
created The Patient Care Partnership brochure and made it available to healthcare
organizations to provide to their patients. The brochure states:
Our hospital works hard to keep you safe. We use special policies and procedures
to avoid mistakes in your care and keep you free from abuse or neglect. If anything
unexpected and significant happens during your hospital stay, you will be told what
happened, and any resulting changes in your care will be discussed with you.
How does this standard of conduct apply to the radiation therapy incident at
Paradise Hills? The management team and the physicians involved should review
its applicability. Their review should consider the patients’ and their family members’ interpretation of the standard as well.
As healthcare becomes more outcomes driven, “transparency is not only the
right thing to do, but also the pragmatic thing to do” according to Toby Cosgrove
(2013), past president and CEO of Cleveland Clinic. Cleveland Clinic was a pioneer in transparency. Its patients have “a clear window into their medical information” through universal access to medical records during their entire care process.
After they go home, patients can sign in to MyChart to review all of their care,
renew prescriptions, make appointments, and consult with their doctor’s office.
When patients have such immediate and ongoing access to their medical records,
physicians and other clinicians have no choice but to keep patients informed
of all aspects of their care, including medical errors. This access makes patients
active partners in the care process and provides them with the information they
need to make informed decisions about their care and treatment, including what
actions to take when medical errors occur. The staff at Cleveland Clinic believe
that patients have a right to know and that this kind of transparency holds the
staff accountable and makes them better (Cosgrove 2013). Cleveland Clinic has
become a model for transparency, with similar patient programs being adopted
throughout the country.
Do patients and their families have a right to know when a medical error has
occurred during the course of their treatment? A look at the history of medical
errors—the acknowledgment that they occur, the number of lives they claim, and
national efforts to decrease their incidence—is instructive, as the following section
discusses.
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Adherence to the Organization’s Mission Statement,
Ethical Standards, and Values Statement
The Institute of Medicine report To Err Is Human: Building a Safer Health System (Kohn, Corrigan, and Donaldson 1999) claimed that medical errors in the
nation’s hospitals, clinics, and physician offices account for the deaths of nearly
100,000 Americans each year. Not surprisingly, this landmark report was covered
extensively by the media, which in turn prompted a rapid political response.
Congressional hearings, a report from the Quality Interagency Coordination Task
Force (2000) titled Doing What Counts for Patient Safety: Federal Actions to Reduce
Medical Errors and Their Impact, and a major policy speech by President Bill Clinton on reducing medical errors soon followed.
In his speech, President Clinton introduced a national action plan to reduce
preventable medical errors by 50 percent within five years (Pilla 2000). This
action plan called for
•
•
•
•
•
$20 million for the creation of a Center for Quality Improvement and
Patient Safety to sponsor research and education in reducing errors;
new regulations requiring all 6,000 hospital participants in the Medicare
program to implement patient safety programs to reduce medical errors;
development of a national, state-based system for reporting medical errors,
including mandatory reporting of preventable errors causing death or
serious injury and voluntary reporting of other medical errors, such as
“near misses”;
support of legislation that protects provider and patient confidentiality
without undermining existing tort remedies; and
new steps to specifically reduce medication errors.
This national action plan signaled government intervention in a domain that
previously had been notorious for “policing its own,” where medical errors had
been kept secret for fear of malpractice litigation, where those committing medical
errors were blamed and punished, and where the prevailing standard for prevention of medical errors was to educate those involved in the hope that such errors
would not happen again.
To change what some called a “conspiracy of silence,” the Institute of Medicine and the Quality Interagency Coordination Task Force (2000) recommended
further actions:
•
Health plans involved in the Federal Employees Health Benefits Program
were required to implement patient safety programs.
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•
•
•
•
•
•
Employers were to incorporate patient safety performance into their
healthcare purchasing decisions.
Periodic relicensing and reexamination of physicians and nurses by state
boards would include knowledge of and competence in patient safety
practices.
Healthcare organizations would establish a goal of continually improved
patient safety.
Healthcare organizations would implement proven medication safety
practices.
Accrediting bodies such as The Joint Commission would review
organizational efforts to minimize errors and promote patient safety.
Computerized medical records would be implemented and integrated with
drug ordering and administrative systems.
For healthcare providers, perhaps the most disconcerting of these recommendations was the mandatory reporting of medical errors to patients and their families. No responsible healthcare professional will argue about the need for strategies
to reduce medical errors and ensure patient safety, but the notion of placing the
organization and its staff at risk for malpractice litigation was worrisome.
Yet, in his policy address, President Clinton stated, “People should have access
to information about a preventable medical error that causes serious injury or
death of a family member, and providers should have protections to encourage
reporting and prevent mistakes from happening again” (Pilla 2000). Is the expectation that healthcare institutions and medical professionals will report their errors
unreasonable? More to the point, is the fear of litigation sufficient justification
for withholding the truth from those affected by medical errors? Any reasonable
healthcare manager will respond, “Of course not.” The patient must always be the
first priority. And yet, knowing the right thing to do may be easier than actually
doing the right thing.
The Institute of Medicine report To Err Is Human had recommended that
Congress create a Center for Patient Safety within the Agency for Healthcare
Research and Quality (AHRQ 2003) to
•
•
set national goals for patient safety, track progress in meeting those goals,
and issue an annual report to the president and Congress on patient
safety; and
develop knowledge and understanding of errors in healthcare by developing
a research agenda, funding centers of excellence, evaluating methods
for identifying and preventing errors, and funding dissemination and
communication activities to improve patient safety.
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In addition, AHRQ was authorized to establish a comprehensive patient safety
initiative to
•
•
•
identify the causes of preventable healthcare errors and patient injury in
healthcare delivery;
develop, demonstrate, and evaluate strategies for reducing errors and
improving patient safety; and
disseminate such effective strategies throughout the healthcare industry.
AHRQ’s Center for Quality Measurement and Improvement was renamed in
2001 as the Center for Quality Improvement and Patient Safety (AHRQ 2015),
which now
•
•
•
conducts and supports user-driven research on patient safety and healthcare
quality measurement, reporting, and improvement;
develops and disseminates reports and information on healthcare quality
measurement, reporting, and improvement; and
collaborates with stakeholders across the healthcare system to implement
evidence-based practices, accelerating and amplifying improvements in
quality and safety for patients.
Despite these agencies’ best efforts, little has changed to stem the tide of medical errors. In fact, many studies suggest the problem is only getting worse. A 2012
US Department of Health and Human Services (HHS) report found that one in
seven Medicare patients died or was harmed by hospital care (Greider 2012). A
2018 Johns Hopkins study found that deaths from medical errors exceed 250,000
per year and remain the third-leading cause of death in the United States (Sipherd
2018). And the Leapfrog Group (2019) indicates that “as many as 440,000 people
die every year from hospital errors, injuries, accidents, and infections. . . . Today
alone, more than 1,000 people will die because of a preventable hospital error.”
According to leadership coach Emmett C. Murphy (2013), citing an Institute of
Medicine finding that more than 80 percent of unnecessary patient deaths are the
result of not putting the patient first, “when patient-first priorities break down,
quality, safety, coordination, satisfaction, and profit all decline.”
Even more disconcerting, as much as 86 percent of harm to Medicare patients
from errors goes unreported (HHS 2012). This failure to report errors is not
surprising, given that many hospitals have been unwilling or unable to transform
their facilities into learning organizations rather than punitive ones. No wonder
American Medical News has claimed that a “fear of punitive response to hospital
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errors lingers” (O’Reilly 2012a), citing an AHRQ survey that found 67 percent
of healthcare professionals said they are concerned that mistakes are held in their
personnel files, and fewer than 50 percent feel free to question decisions or actions
of superiors.
The cost of medical errors has received an increasing amount of media attention in recent years, and the numbers are staggering. One study put the annual
cost of medical errors in the United States near $1 trillion (Goedert 2012). In
2008, in an effort to reduce the cost of medical errors to the government, Medicare adopted a policy of “no pay for never events” (medical errors that should
never happen). This “ethical and patient safety imperative” seems to have induced
hospital leaders to focus more on patient safety and fostered more collaboration
among healthcare professionals (O’Reilly 2008, 2012b).
Despite all of the pressures to disclose medical errors so that they can be
analyzed and prevented in the future, an overriding fear of litigation still exists.
Citing a study that found that 43 percent of 127 families who sued their healthcare providers after perinatal injuries were motivated by revenge or suspicion of a
cover-up, Kraman and Hamm (1999) argued in an oft-cited scholarly article that
honesty is the best policy in risk management. The authors reported on the experiences of one Department of Veterans Affairs medical center that implemented a
policy of full disclosure of medical errors to patients and families (in the presence
of a family attorney, if the family so desired). The medical center initiated this
practice because staff believed it was “the right thing to do.” They also found that
this honest approach resulted in unanticipated financial benefits to the medical
center when lower-cost settlements began replacing higher-cost litigation. This
study remains the definitive scholarly work that provides evidence supporting full
disclosure of medical errors.
Surgeon and health policy expert Marty Makary, MD, determined that most
medical errors are caused by “inadequately skilled staff, errors in judgement or
care, a system defect, or a preventable adverse effect” (Sipherd 2018). The compendium of causes includes “computer breakdowns, mix-ups with the doses or
types of medications administered to patients, and surgical complications that go
undiagnosed” (Sipherd 2018). Makary admonishes healthcare managers to blame
the system rather than individuals (Sipherd 2018). Lucian Leape, MD, generally
considered to be “the father of the modern patient safety movement,” agrees that
“the single greatest impediment to error prevention in the medical industry is that
we punish people for making mistakes” (ACHE 2017b, 1).
A number of strategies have aimed to help healthcare managers reduce
medical errors. Technology, such as computerized physician order entry and electronic medical records, has certainly proven useful. Incentive awards encourage
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e­ mployees to be alert to errors and report them; Mount Sinai Hospital in New
York, for example, gives a “Good Catch Award” to employees who detect potential and existing errors. Encouraging patients to take charge of their healthcare by
downloading a healthcare app to access their medical information, asking questions, seeking second opinions, and bringing a friend or relative along to doctor
visits so that they can ask questions too—all have merit in helping to reduce medical errors (Sipherd 2018).
A word about transparency may be in order here. Transparency has become the
buzzword during the past decade for all that is right. Transparency is advocated
in business, government, and healthcare (especially recently). In his book Unaccountable: What Hospitals Won’t Tell You and How Transparency Can Revolutionize
Health Care, Makary (2012) advocates making more hospital performance metrics
public and cautions that a lack of transparency leaves flaws unchecked and systems
uncorrected.
What kind of information, and how much, is appropriate to disclose? And
to whom should it be disclosed? A political commentator recently questioned the
wisdom of too much transparency, arguing that the public is getting bogged down
in the minutiae and that backdoor bickering and grandstanding are obscuring the
real issues the public needs to grapple with. Transparency needs to be tempered
with judgment. The CEO of one not-for-profit organization proudly spoke of his
philosophy that “dirty laundry needs to be aired,” but some influential members
resigned from the organization because they believed he was publicly sharing too
much detail about internal staff conflicts that leadership should have handled
quietly.
A case can be made that the greatest positive effect of transparency is that
the mere idea of it directs an organization’s culture and activities in ways that can
withstand public scrutiny whether the public needs to know about them or not.
Transparency should lead to resources being committed to activities that are in the
best interests of patients and the community being served. As a physician once
put it during a discussion about transparency, “If you’re going to be naked, you’d
better be buff.” Although the language may be brash, the advice is good.
Today’s managers must consider more than just how their actions would play
on CNN. Thanks to social media, an organization’s actions may quickly become
the latest viral internet sensation, with a series of unintended consequences.
Adherence to Professional Codes of Ethical Conduct
Do the existing codes of ethical conduct promulgated by the professional organizations and associations representing physicians, healthcare executives, and
hospitals require that the incident at Paradise Hills be fully disclosed to the
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patients involved? The Code of Medical Ethics of the American Medical Association (AMA 2019) states:
In the context of health care, an error is an unintended act or omission or a flawed
system or plan that harms or has the potential to harm a patient. Patients have a
right to know their past and present medical status, including conditions that may
have resulted from medical error. Open communication is fundamental to the trust
that underlies the patient-physician relationship, and physicians have an obligation
to promote patient welfare and safety. Concern regarding legal liability should not
affect the physician’s honesty with the patient.
Even when new information regarding the medical error will not alter the
patient’s medical treatment or therapeutic options, individual physicians who have
been involved in a (possible) medical error should:
(a) Disclose the occurrence of the error, explain the nature of the (potential) harm
and provide the information needed to enable the patient to make informed
decisions about future medical care.
(b) Acknowledge the error and express professional and compassionate concern
towards patients who have been harmed in the context of health care.
(c) Explain the efforts that are being taken to prevent similar occurrences in the future.
(d) Provide for continuity of care to patients who have been harmed during the
course of care, including facilitating transfer of care when a patient has lost trust
in the physician.
Physicians who have discerned that another health care professional (may have) erred
in caring for a patient should:
(e)    Encourage the individual to disclose.
(f )    Report impaired or incompetent colleagues in keeping with ethics guidance.
As professionals uniquely positioned to have a comprehensive view of the care
patients receive, physicians must strive to ensure patient safety and should play a
central role in identifying, reducing and preventing medical errors. Both as individuals and collectively as a profession, physicians should:
(g) Support a positive culture of patient safety, including compassion for peers who
have been involved in a medical error.
(h) Enhance patient safety by studying the circumstances surrounding medical error.
A legally protected review process is essential for reducing health care errors and
preventing harm.
(i) Establish and participate fully in effective, confidential, protected mechanisms
for reporting medical errors.
(j) Participate in developing means for objective review and analysis of medical errors.
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33
(k) Ensure that all investigation of root causes and analysis of error leads to measures
to prevent future occurrences and that these measures are conveyed to relevant
stakeholders.
The Code of Ethics of the American College of Healthcare Executives (ACHE
2017a) states:
The healthcare executive shall conduct professional activities with honesty, integrity,
respect, fairness and good faith in a manner that will reflect well upon the profession. . . . The healthcare executive shall, within the scope of his or her authority,
work to ensure the existence of a process that will advise patients or others served
of the rights, opportunities, responsibilities and risks regarding available healthcare
services.
These ethical standards provide clear guidance to those wrestling with the ethical dilemma at Paradise Hills. As professionals, the physicians must disclose and
discuss medical errors with their patients. Although the language in the ACHE
Code of Ethics is more general, the executives at Paradise Hills must determine if
their actions are consistent with the ethical standards that apply to them.
In 2017, ACHE joined forces with the Lucian Leape Institute of the Institute
for Healthcare Improvement and National Patient Safety Foundation to create
Leading a Culture of Safety: A Blueprint for Success—an evidence-based, practical
resource that provides tools and proven strategies for healthcare leaders seeking
to develop a safe environment for patients at every level of their organization
(exhibit 3.1). The document’s goals and strategies, both foundational and sustaining, are organized around six leadership domains, each of which requires the focus
and commitment of the CEO:
1.
2.
3.
4.
5.
6.
Establish a compelling vision for safety.
Build trust, respect, and inclusion.
Select, develop, and engage your board.
Prioritize safety in the selection and development of leaders.
Lead and reward a just culture.
Establish organizational behavior expectations.
The safety Blueprint also includes a self-assessment tool that organizations can
use to evaluate their strengths and weaknesses in this arena and to better plan where
resources should be deployed (Wagner 2019). Several prominent healthcare leaders
have testified to the Blueprint’s merit and usefulness in their organizations (­Wagner
2019). The complete document can be downloaded at http://safety.ache.org
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Exhibit 3.1: Six Domains for Developing a Culture of Safety
Vision
Behavior
Expectations
Trust,
Respect, and
Inclusion
ZERO HARM
Just
Culture
to Patients,
Families, and the
Workforce
Board
Engagement
Leadership
Development
as
ba
ck
Me
O
T
ure RGA
E N ee d
M
m e N IZ A
F
VE
nt • T I O N
PR O ti o n •
M
I
Ana A L LE A
S
RN
l y si s
e nt a
IN UO U
and in ING – CONT e implem
terpretation • Chang
Source: ACHE (2017b, 5).
along with other valuable resources, tools, and best practices for building a culture of safety.
The guidance offered here supports the argument that ethical matters involving patient–physician relationships are, in fact, the business of hospital management and cannot be relegated to the medical staff alone. Senior-level healthcare
managers must work in direct partnership with the medical staff to provide the
safest possible care environment for patients.
Understanding the Medical Staff Perspective
That the physicians at Paradise Hills take a different view is not surprising. A
basic understanding of the medical staff orientation helps explain why physicians
adamantly protect what they consider to be their professional province.
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35
Physicians typically enjoy a supreme position in the hospital’s organizational
hierarchy. They generally establish and maintain the rules that regulate most
patient care in the hospital, and they serve as gatekeepers in admitting patients to
the healthcare system. Once patients are admitted for care, they and their caregivers are required to follow “doctor’s orders.” Physicians thus set the standards for
patient care and define illness.
Physicians are granted the authority to define illness because they possess “a
body of knowledge that defines and constructs the roles to be played in the context of the institution” (Berger and Luckmann 1967, 67). Roles make it possible
for institutions to exist. The role physicians play inducts them into specific areas
of knowledge, not only in the narrower cognitive sense but also in the sense of
norms, values, and even emotions. This knowledge may become so internalized
that physicians consider the role “an inevitable fate for which [they] may disclaim
responsibility.” Thus, they might say, “I have no choice in the matter, I have to act
this way because of my position” (Berger and Luckmann 1967, 76).
Physicians learn their role through a complex socialization process that begins
when they enter medical school. The rigors and expense of medical school, the
admission requirements, the protégé system, and the collegial bonds of the medical profession all reflect occupational socialization. On completion of medical
school, the symbolic universe of physicians includes elaborate rights, obligations,
standard practices, and a role-specific vocabulary. Physicians are now socialized to
play the role as definers of reality for patients (Berger and Luckmann 1967, 91).
The effects of this socialization on the moral reasoning of medical students was
the subject of an important study conducted by Hébert, Meslin, and Dunn (1992)
at the University of Toronto. Students in all four years of medical school participated in the study; the first-year students completed the survey during their medical school orientation. The research instrument presented four clinical scenarios,
and the respondents were asked to list the ethical issues in each. Significantly, the
fourth-year students identified far fewer ethical issues than the first-year students
did. The researchers concluded that “these studies show a disturbing pattern; the
ethical sensitivity of medical students seems to decrease with more time in medical
school. Is this the consequences of medical socialization and is it harmful?”
Thus, physicians approach the world very differently than hospital administrators do. “Physicians tend to be doers, reactive, independent, solo decisionmakers, business owners,” whereas hospital administrators “tend to be planners,
proactive, participative, collaborative problem solvers, business stewards” (Peck
2012). Physicians tend to focus on individual patients, whereas administrators
focus on the overall organization. To work together successfully, they must reach
agreement that what is good for individual patients and what is good for the organization are one and the same.
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In any discussion about the role of physicians, some attention must be
given to professionalism. Professionals, such as physicians, lawyers, accountants,
and healthcare executives, have a number of characteristics in common. They
typically form associations, establish licensing or certifications, require specialized
education, codify standards of conduct, have their own language, and promote
professional autonomy and self-regulation. These characteristics tend to foster
exclusivity and place professionals in a position of dominance in society. Some will
argue that physicians’ position of dominance is justified because they must make
life-and-death decisions. Advocates of patient self-determination, however, claim
that physician dominance is detrimental—that the health status of individuals or
populations can improve only when they have a better understanding of health
promotion, disease prevention, and disease management.
At Paradise Hills, the physicians believe that matters of patient care fall strictly
in their domain because of occupational socialization and the professional dominance they enjoy.
Discrimination Against a Class of Patients
Labeling the patients in the Paradise Hills case as “terminal” and treating them
differently from the way other groups in similar situations are treated is arguably a
form of discrimination. Situations where withholding information because of class
distinctions appears to be the norm can place decision-makers on a slippery slope,
because allowing this action with one group may be taken as permission to replicate it among other groups. Treating certain patients differently can be especially
dangerous in healthcare organizations, whose patient, employee, and professional
populations are becoming increasingly diverse.
Who decides if withholding information from a particular patient or group
is appropriate? As the population ages and resources become increasingly scarce,
the debate about limiting treatment options for the aged will rage on. This issue
is not new; when dialysis and kidney and heart transplants were introduced in the
1960s, the same discussions took place. Around the same time, ethics committees
were finding their way into the hospital setting. However, costs are now central
to the discussions, so more conflicts are likely to occur. When the issues at stake
involve “priceless” lives and the cost–benefit analysis of treatments, the following
questions are likely to come into consideration:
•
•
•
Does extended quality of life for the individual matter?
Does the individual’s contribution or future contribution to society matter? For
example, is treating a rocket scientist different from treating a homeless person?
Where does self-determination fit into the equation?
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•
•
•
•
•
•
Do “believers” of a certain religion or sect get priority over “nonbelievers”?
Do patients born in the United States get priority over immigrants?
What about those who have abused their bodies—substance abusers,
alcoholics, smokers, or the obese?
Does it matter who is paying the bill—government, insurance, or private pay?
When dealing with the aged, are all 75-year-olds equal physically, mentally,
emotionally, and intellectually?
Who should participate in these decisions?
These same questions may be asked in the future to determine whether costly
medications or procedures should be part of the treatment plan for any patient,
not just those of a particular group. Clearly, the ethical implications of these
decisions will weigh heavily on the minds of healthcare managers faced with the
responsibility of developing organizational structures to deal with such issues. A
national conversation about this topic is necessary, one that does not allow political interests and hysteria to influence the discussion. Healthcare executives must
take the lead in framing the discussion and in developing language and terminology that allow the discussion to take place without talk of “death panels.”
Management’s Role and Responsibility
What are the role and responsibility of hospital management in the Paradise Hills
case? What are the role and responsibility of the hospital CEO specifically? A literal interpretation of the standards of ethical conduct promulgated by ACHE and
the AHA (see above) would indicate that the role of the CEO in this case is burdensome because the CEO must balance complex needs and conflicting interests.
In fulfilling all his duties, the CEO has responsibilities to the governing board,
the institution, the medical staff, the employees, the community, the patients, the
profession, and himself.
The CEO’s mandate is to carry out the policies of the governing board, which
include ensuring compliance with the board-approved ethical standards for the
practices of the institution. The CEO is likewise charged with the responsibility of
ensuring that the institution operates in ways that are consistent with its mission
and values statements.
Partnering with the Medical Staff
The management staff at Paradise Hills have a strong working relationship with
the medical staff. The oncology physicians have been especially loyal and committed to Paradise Hills, and in return hospital management has provided them with
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the resources and technology they need to practice state-of-the-art medicine. It has
been a win–win situation for Paradise Hills. The CEO is determined to arrive at a
solution to this problem that will preserve the existing medical staff–management
relationship. Not incidentally, he knows he must avoid alienating these communitybased physicians, whose patients are vital to the financial viability of the hospital.
Leadership hospitals generally embrace the core belief that medical staff participation is essential to the successful operations and strategic planning of the
institution. Management in such an institution enthusiastically integrates medical
staff participation into its way of doing business, fosters ongoing dialogue with
physicians, and recognizes the medical staff as a needed resource. The CEO at
Paradise Hills has worked to develop such an environment and is staunch in his
resolve that the medical staff must be full and active participants in this ethical
decision-making. The CEO believes that a satisfactory solution to this incident
must not violate confidentiality of patient information, must not infringe on or
threaten patient–physician relationships, and must not precipitate a lawsuit. He
knows that to secure these objectives, he must work closely with the medical staff
and avoid an adversarial confrontation. The physicians must be full partners in
the analysis and resolution of the problem. Their voice in the proceedings must be
heard and attended to. The outcome must be one in which they have been allowed
to exercise some element of control.
Fortunately, the CEO at Paradise Hills is armed with the primary prerequisite
to successful partnering with the medical staff: They trust him. To solve this ethical problem successfully, he must be well prepared with solid facts, a well-thoughtout rationale for action, and a commitment and plan to deal with all consequences
of the actions taken.
The CEO and management staff must also recognize that medical errors take
their toll on the physicians and other staff who are involved in an incident. In an
organizational culture that emphasizes perfection, self-reproach, and accountability, guilt can affect a clinician’s effectiveness in future patient care. Management
must therefore take measures to assist staff in appropriately coping with medical
errors (Morreim 2000, 56).
Leadership
In this case, as in all ethical matters, the CEO has enormous leadership responsibility. The CEO is responsible for the ethical culture in the organization, implementing the standards of ethical conduct, and serving as an ethical role model for
staff. While clinical professionals may bring their own codes of conduct to the
workplace, management must set the tone for how business is conducted, how
professionals interact, and how patients are served.
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Bennis and Namus (1985, 186) are clear on this point: “The leader is responsible for the set of ethics or norms that govern the behavior of people in the organization. Leaders set the moral tone.” Nancy Schlichting, former CEO of Henry
Ford Health System, says (quoted in Rice and Perry 2013, 33), “The greatest
deterrent to unethical behavior is values-driven leadership. When people stand for
something and there are visible symbols of those values for all to see, they hold it
up and measure against it. Employees look at what the leaders are doing and they
feel free to come forward and challenge behaviors that do not meet that standard.”
According to Hofmann (quoted in Rice and Perry 2013, 38), “the consistent
and absolute intolerance of unethical behavior” is a leadership responsibility. “A
policy of zero tolerance means swift action is taken when it occurs, regardless of
organizational status. Prerequisites include a comprehensive and unambiguous
code of conduct that is well disseminated and understood; no disconnect between
the rhetoric and reality of organizational values; [and] behavior of all organizational leaders and staff members that is always above reproach.” The significance
of the leader as a role model should not be underestimated. Through their behavior, leaders define what is acceptable and what is not. Others in the organization
will seek to emulate those behaviors to gain favor or status.
Ethical problems are a true managerial dilemma because they often represent
conflict between an organization’s financial performance and its responsibilities to
the community and the patients it serves. In the Paradise Hills case, will telling
the patients about the errors reduce the public’s trust in the organization and dissuade patients from being treated there? Will telling the patients about the errors
alienate the physicians and induce them to admit their patients to other facilities?
This case, like all ethical problems, requires that the CEO, his management team,
and the medical staff think through the consequences of their actions on multiple
dimensions using ethical analysis as well as bottom-line considerations. While the
task is complex and the conflicts may appear insurmountable, Bennis and Namus
(1985, 186) remind us that “leaders are persons who are able to influence others;
this influence helps to establish the organizational climate for ethical conduct;
ethical conduct generates trust; and trust contributes substantially to the longterm success of the organization.”
The Betsy Lehman Case
A real-life case that is strikingly similar to the Paradise Hills incident involved
Betsy Lehman and the Dana-Farber Cancer Institute.
Betsy Lehman was a health news reporter for the Boston Globe, and her husband was a scientist at the Dana-Farber Cancer Institute. She died in December
1994 while undergoing chemotherapy at Dana-Farber. Her overdose error was
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discovered in February 1995 during a medical records review. This tragic case
underscores the interrelatedness of management, clinical care, and ethics and
drives home the point that leadership cannot delegate risk management but must
make risk management its own responsibility.
The Betsy Lehman case has been considered a landmark event in the evolution
of national attention given to medical errors. It was certainly well publicized. The
Boston Globe broke the story in March 1995 with the headline “Doctor’s Orders
Kill Cancer Patient.” An ABC News special with Barbara Walters and Dr. ­Timothy
Johnson, “Betsy Lehman and Medical Errors in U.S. Hospitals,” aired in July
1995. Even Lucian Leape, long considered a pioneer advocate for patient safety,
appeared on national television as an authority on the prevalence and causes of
medical errors. Notably, the Institute of Medicine report To Err Is Human was
published a few years later, in November 1999, and patient safety initiatives—
including federal legislation intended to reduce medical errors—soon followed.
A root-cause analysis of the Betsy Lehman case revealed the breakdown of a
complex medication process compounded by a lack of communication, illegible
physician handwriting, and professional arrogance. Although the human loss in
this case was immeasurable, the organization also suffered a public relations crisis
that had an extensive negative impact on merger negotiations; staff morale; clinical trials; donations; and the recruitment of physicians, nurses, and researchers.
Both The Joint Commission and the state of Massachusetts placed Dana-Farber
on probation, affecting both its Medicare reimbursement and its ability to treat
patients. This case was published by Harvard Business School and is used as a
teaching tool in university programs throughout the United States (Bohmer and
Winslow 1999).
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Agency for Healthcare Research and Quality (AHRQ). 2015. “Center for Quality
Improvement and Patient Safety.” Reviewed December. www.ahrq.gov/cpi/centers/
cquips/index.html.
———. 2003. “AHRQ’s Patient Safety Initiative: Breadth and Depth for Sustainable
Improvements.” Chapter 3 in AHRQ’s Patient Safety Initiative: Building
Foundations, Reducing Risk. Updated December. www.ahrq.gov/research/findings/
final-reports/pscongrpt/index.html.
American College of Healthcare Executives (ACHE). 2017a. Code of Ethics. As
amended November 13. www.ache.org/about-ache/our-story/our-commitments/
ethics/ache-code-of-ethics.
———. 2017b. Leading a Culture of Safety: A Blueprint for Success. Accessed March 17,
2019. http://safety.ache.org/blueprint/.
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American Hospital Association (AHA). 2003. “The Patient Care Partnership:
Understanding Expectations, Rights and Responsibilities.” Accessed July 1, 2013.
www.aha.org/advocacy-issues/communicatingpts/pt-care-partnership.shtml.
American Medical Association (AMA). 2019. “Promoting Patient Safety.” Code of
Medical Ethics Opinion 8.6. Accessed March 16. www.ama-assn.org/deliveringcare/ethics/promoting-patient-safety.
Bennis, W., and B. Namus. 1985. Leaders: The Strategies for Taking Charge. New York:
Harper and Row.
Berger, P. L., and T. Luckmann. 1967. The Social Construction of Reality. Garden City,
NY: Anchor Books.
Bohmer, R. M. J., and A. Winslow. 1999. “The Dana-Farber Cancer Institute.”
Harvard Business School Case 699-025. Revised July. www.hbs.edu/faculty/Pages/
item.aspx?num=304.
Cosgrove, T. 2013. “Transparency: A Patient’s Right to Know.” Institute of Medicine
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RightToKnow.aspx.
Goedert, J. 2012. “Study Pegs Cost of Medical Errors Near $1 Trillion Annually.”
HealthData Management. Published October 19. www.healthdatamanagement.
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Greider, K. 2012. “The Worst Place to Be If You’re Sick.” AARP Bulletin. Published
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Hébert, P. C., E. M. Meslin, and E. V. Dunn. 1992. “Measuring the Ethical Sensitivity
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Iezzoni, L. I., S. R. Rao, C. M. DesRoches, C. Vogeli, and E. G. Campbell. 2012.
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Kohn, L. T., J. M. Corrigan, and M. S. Donaldson (eds.). 1999. To Err Is Human:
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Kraman, S. S., and G. Hamm. 1999. “Risk Management: Extreme Honesty May Be
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Kübler-Ross, E. 1969. On Death and Dying. New York: Macmillan Publishing Co.
Leapfrog Group. 2019. “Errors, Injuries, Accidents, Infections.” Leapfrog Hospital
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Makary, M. 2012. Unaccountable: What Hospitals Won’t Tell You and How Transparency
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Murphy, E. C. 2013. “Why Do Healthcare Executives Fail?” Murphy Leadership
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O’Reilly, K. B. 2012a. “Fear of Punitive Response to Hospital Errors Lingers.”
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———. 2012b. “Medicare’s No-Pay Rule Sharpens Infection-Control Efforts.”
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———. 2008. “No Pay for ‘Never Events’ Becoming Standard.” American Medical News.
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27, 2013. http://archive.ahrq.gov/quic/report/mederr2.htm.
Rice, J., and F. Perry. 2013. Healthcare Leadership Excellence: Creating a Career of
Impact. Chicago: Health Administration Press.
Sipherd, R. 2018. “The Third Leading Cause of Death in US Most Doctors Don’t
Want You to Know About.” CNBC. Published February 22. www.cnbc.
com/2018/02/22/medical-errors-third-leading-cause-of-death-in-america.html.
US Department of Health and Human Services (HHS). 2012. “Hospital Incident
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Wagner, K. 2019. “Executing on Your Safety Priorities.” Healthcare Executive 34 (2):
17–23.
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Additional Resources
Informed Consent
•
•
•
•
Barstow, C., et. al. Evaluating Medical Decision-Making Capacity in Practice. Am
Fam Physician. 2018 July 1, 98(10): 40-46
https://www.aafp.org/afp/2018/0701/p40.html
AMA Informed Consent. Code of medical Ethics opinion 2.1.1 https://www.amaassn.org/delivering-care/ethics/informed-consent
Maryland Treatment without consent
https://law.justia.com/codes/maryland/2015/article-ghg/title-5/subtitle-6/parti/section-5-607/
Sample Refusal of Consent form
https://www.medicaleconomics.com/view/sample-refusal-consent-form
Limited English Proficiency
•
•
•
Limited English Proficiency (LEP) https://www.lep.gov/
HHS Revised Limited English Proficiency (LEP) Guidance
https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-englishproficiency/index.html
Fact Sheet on the Revised LEP Guidance https://www.hhs.gov/civil-rights/forindividuals/special-topics/limited-english-proficiency/fact-sheetguidance/index.html
Minor Consent
•
•
•
•
•
HHS Informed Consent FAQ https://www.hhs.gov/ohrp/regulations-andpolicy/guidance/faq/informed-consent/index.html
Maryland Consent and Treatment of Minors
https://health.maryland.gov/psych/pdfs/Treatment.pdf
Maryland code and Minor Consent to Treatment
https://codes.findlaw.com/md/health-general/md-code-health-gen-sect-20102.html
2.2.1 Pediatric Decision Making https://policysearch.amaassn.org/policyfinder/detail/pediatric%20decision%20making?uri=%2FAMADoc%
2FEthics.xml-E-2.2.1.xml
A Guardian’s Health Care Decision -Making Authority: Statutory Restrictions
https://www.americanbar.org/groups/law_aging/publications/bifocal/vol_35/issue_
4_april2014/guardianship_health_care_decisions_statutory_restrictions/
Research Consent
•
•
•
•
•
Maryland Law on Human Subject Research
https://www.marylandattorneygeneral.gov/Pages/HealthPolicy/humansubject.asp
x
HHS 2018 Common Rule on research consent and Institutional Review Boards
(IRB) https://www.ecfr.gov/cgibin/retrieveECFR?gp=&SID=83cd09e1c0f5c6937cd9d7513160fc3f&pitd=201807
19&n=pt45.1.46&r=PART&ty=HTML
HHS Revision of the Common Rule https://www.hhs.gov/ohrp/regulations-andpolicy/regulations/revision-of-the-common-rule/index.html
FDA Right to Try Act https://www.fda.gov/patients/learn-about-expanded-accessand-other-treatment-options/right-try
FDA Informed Consent: Draft Guidance for IRBs, Clinical Investigators, and
Sponsors (July 2014) https://www.fda.gov/patients/learn-about-expandedaccess-and-other-treatment-options/right-try
Patient Rights
•
•
•
Maryland Patient Bill of Rights
https://hscrc.maryland.gov/Pages/consumers_patientsRights.aspx
Maryland Code Hospital Patient Rights
https://law.justia.com/codes/maryland/2005/ghg/19-342.html and
https://law.justia.com/codes/maryland/2019/health-general/title-19/subtitle-3/partvi/sect-19-343/
Maryland long term care ombudsman program Pages – Ombudsman Program
(maryland.gov)
•
•
•
•
Maryland Health Care Commission (MHCC) Resident’s Rights and Services
https://mhcc.maryland.gov/consumerinfo/longtermcare/documents/resident_right
s.pdf
42 C.F.R. 483.10 Long Term Care Resident rights
https://ecfr.federalregister.gov/current/title-42/chapter-IV/subchapter-G/part483/subpart-B#483.10
Maryland Consumer Guide to Long Term Care
https://mhcc.maryland.gov/consumerinfo/longtermcare/GeneralResources.aspx
Medical
Restraints and Seclusion
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42 C.F.R. 483.358 Orders for the use of restraint or seclusion
https://www.law.cornell.edu/cfr/text/42/483.358
Maryland Regulations Restraints COMAR 10.21.12.02 Definitions
http://mdrules.elaws.us/comar/10.21.12.02 , through COMAR 10.21.12.12
Abuse and Neglect and Reporting
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Elder Justice Act 42 U.S.C. 1397j
https://www.law.cornell.edu/uscode/text/42/1397j
42 C.F.R. 483.12 Freedom from abuse, neglect and exploitation
https://ecfr.federalregister.gov/current/title-42/chapter-IV/subchapter-G/part483/subpart-B#483.12
Maryland Department of Aging: Preventing Elder Abuse and Neglect
https://aging.maryland.gov/Pages/elder-abuse-prevention.aspx
Mandatory Reporting Requirements: The Elderly in Maryland
https://apps.rainn.org/policy/policy-state-lawsexport.cfm?state=Maryland&group=5
Infectious Disease Reporting
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•
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CDC: Mandatory reporting of infectious diseases by clinicians. MMWR (June 22,
1990) 33(RR-9) 1-11, 16-17
https://www.cdc.gov/mmwr/preview/mmwrhtml/00001665.htm
CDC 2021 National Notifiable Conditions
https://wwwn.cdc.gov/nndss/conditions/notifiable/2021/
Maryland Department of Health Reportable Diseases
https://phpa.health.maryland.gov/pages/reportable-diseases.aspx
HIPAA and Public Health https://www.hhs.gov/hipaa/for-professionals/specialtopics/public-health/index.html
Mental Health Duty to Warn, and Substance Use Disorder (SUD)
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•
NCSL Mental Health Professional’s Duty to Warn
https://www.ncsl.org/research/health/mental-health-professionals-duty-towarn.aspx
Treatment Guidelines: Substance Use Disorders Treatment Guidelines: Substance Use
Disorders | cpnp.org
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•
•
CMS Substance Use Disorders https://www.cms.gov/outreacheducation/american-indianalaska-native/behavioral-health/substance-usedisorders
SAMHSA National Guidelines for Behavioral Health Crisis Care: Best Practice
Toolkit https://www.samhsa.gov/sites/default/files/national-guidelines-forbehavioral-health-crisis-care-02242020.pdf
SAMHSA Use of Medication-Assisted Treatment in Emergency Departments Use
of Medication-Assisted Treatment in Emergency Departments | SAMHSA
Medical Error
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To Err is Human: Building a Safer Health System, Institute of Medicine, 2000
https://www.ncbi.nlm.nih.gov/books/NBK225182/
AHRQ Medical Error https://www.ahrq.gov/topics/medical-errors.html
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•
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The Hastings Center Medical Error
https://www.thehastingscenter.org/briefingbook/medical-error/
AHRQ Disclosure of Errors (Sept. 2019)
https://psnet.ahrq.gov/primer/disclosure-errors
ACEP Disclosure of Medical Errors https://www.acep.org/patient-care/policystatements/disclosure-of-medical-errors/
JCAHO Speak Up Preventing Medical Errors
https://www.jointcommission.org/resources/for-consumers/speak-upcampaigns/preventing-medicine-errors/
ISMP List of Confused Drug Names
https://www.ismp.org/recommendations/confused-drug-names-list
ISMP Targeted Medication Safety Best Practices for Hospitals
https://www.ismp.org/guidelines/best-practices-hospitals
Medical Negligence
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•
•
•
•
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Medical Malpractice Overview https://www.findlaw.com/injury/medicalmalpractice/medical-malpractice-overview.html
Legal Concepts in a Medical Malpractice Case
https://www.alllaw.com/articles/nolo/medical-malpractice/legal-conceptscase.html
Defenses to Medical Malpractice https://www.findlaw.com/injury/medicalmalpractice/defenses-to-medical-malpractice-patients-negligence.html
Maryland Medical Malpractice Laws https://www.nolo.com/legalencyclopedia/maryland-medical-malpractice-laws.html
Vicarious Liability https://www.findlaw.com/injury/medical-malpractice/vicariousliability.html
Respondeat superior
https://www.law.cornell.edu/wex/respondeat_superior#:~:text=A%20legal%20doc
trine%2C%20most%20commonly,of%20the%20employment%20or%20agency.
42 C.F.R.483.70(n) Long Term Care: Binding arbitration agreements
https://ecfr.federalregister.gov/current/title-42/chapter-IV/subchapter-G/part483/subpart-B#483.70
NCSL Medical Liability/Malpractice ADR and Screening Panels Statutes
https://www.ncsl.org/research/financial-services-and-commerce/medical-liabilitymalpractice-adr-and-screening-panels-statutes.aspx
Fraud
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Maryland fraud laws https://law.justia.com/codes/maryland/2010/criminallaw/title-8/
•
•
HHS OIG Fraud and Abuse Laws https://oig.hhs.gov/compliance/physicianeducation/01laws.asp#:~:text=It%20is%20illegal%20to%20submit,plus%20%241
1%2C000%20per%20claim%20filed.&text=Criminal%20penalties%20for%20sub
mitting%20false%20claims%20include%20imprisonment%20and%20criminal%2
0fines.
Health care Compliance Program Tips https://oig.hhs.gov/compliance/providercompliance-training/files/Compliance101tips508.pdf
Patient Safety – Violence and Disruptive Behavior
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OSHA Workplace Violence Workplace Violence – Overview | Occupational Safety and
Health Administration (osha.gov)
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•
•
•
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Joint Commission Sentinel Event Alert 40: Behaviors that Undermine a culture of
safety (Sept 2016) https://www.jointcommission.org/resources/patient-safetytopics/sentinel-event/sentinel-event-alert-newsletters/sentinel-event-alert-issue40-behaviors-that-undermine-a-culture-of-safety/
Joint Commission Sentinel Event Alert 59: Physical and verbal violence against
health care workers https://www.jointcommission.org/resources/patient-safetytopics/sentinel-event/sentinel-event-alert-newsletters/sentinel-event-alert-59physical-and-verbal-violence-against-health-care-workers/
The Joint Commission: The Consequences of Unchecked Disruptive Behaviors
in Health Care (Jan 30, 2020) https://www.jointcommission.org/resources/newsand-multimedia/blogs/improvement-insights/2020/01/30/consequences-ofunchecked-disruptive-behaviors-in-health-care/
AHRQ Patient Safety network – Disruptive and Unprofessional Behavior
https://psnet.ahrq.gov/primer/disruptive-and-unprofessional-behavior
MGMA Dealing with Disruptive physicians (May 1, 2016)
https://www.mgma.com/resources/human-resources/dealing-with-disruptivephysicians
AMA Code of Medical Ethics Opinion 9.4.4 Physicians with Disruptive Behavior
https://www.ama-assn.org/delivering-care/ethics/physicians-disruptive-behavior
Patient Safety – Falls
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AHRQ’s Safety Program for Nursing Homes: On-Time Falls Prevention
https://www.ahrq.gov/patient-safety/settings/long-termcare/resource/ontime/fallspx/index.html
CMS Compliance Group Fall Prevention Resources

Fall Prevention Resources

Preventing Falls in Hospitals: A Toolkit for Improving Quality of Care Preventing
Falls in Hospitals: A Toolkit for Improving Quality of Care. | PSNet (ahrq.gov)
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AHRQ Long Term Care Facility – Patient Safety Tools
https://www.ahrq.gov/patient-safety/resources/pstools/index.html#facilities
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AHRQ Ambulatory Care Settings Patient Safety Tools
https://www.ahrq.gov/patient-safety/resources/pstools/index.html#ambulatory
AHRQ Emergency Room Patient Safety Tools https://www.ahrq.gov/patientsafety/resources/pstools/index.html#dept
Health Care Quality Improvement Act (HCQIA)
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The Healthcare Quality Improvement Act (HCQIA) 42 U.S. Code § 11101 – Findings |
U.S. Code | US Law | LII / Legal Information Institute (cornell.edu)
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Maryland Medical Review Committees (peer review)
https://law.justia.com/codes/maryland/2013/article-gho/section-1-401/
AMA Peer Review Survival Kit: Is your peer review process safe?
https://www.ama-assn.org/system/files/2019-11/i19-peer-review-survival-kit.pdf
Defending the Peer Review privilege: Guidance for Health are Providers and
Counsel After Wheeling Hospital, West Virginia Law Review (2017)
https://wvlawreview.wvu.edu/west-virginia-law-reviewonline/2017/11/17/defending-the-peer-review-privilege-guidance-for-health-careproviders-and-counsel-after-wheeling-hospital
Credentials Committee: Essentials Handbook
https://hcmarketplace.com/media/browse/10552_browse.pdf
Patient Safety and Quality Improvement Act (PSQIA)
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HHS PSQIA https://www.hhs.gov/hipaa/for-professionals/patient-safety/statuteand-rule/index.html
Patient Safety Improvement Act (PSIA)of 2020
https://psnet.ahrq.gov/issue/patient-safety-improvement-act-2020
Patient Safety Organization (PSO) https://www.pso.ahrq.gov/
Patient Safety Rule https://www.hhs.gov/hipaa/for-professionals/patientsafety/patient-safety-rule/index.html
Patient Safety Organizations and Patient Safety work product
https://www.law.cornell.edu/cfr/text/42/part-3
HHS Guidance for Patient Safety Rules https://www.hhs.gov/hipaa/forprofessionals/patient-safety/guidance/index.html
National Practitioner Data Bank (NPDB)
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National Practitioner Data Bank (NPDB) https://www.npdb.hrsa.gov/
National Practitioner Data Bank (NPDB) Guidebook
https://www.npdb.hrsa.gov/resources/aboutGuidebooks.jsp
National Practitioner Data Bank ( NPDB) What you Must Report to the NPDB
https://www.npdb.hrsa.gov/hcorg/whatYouMustReportToTheDataBank.jsp
•
Reporting Peer Review Organization Negative Actions or Findings
https://www.npdb.hrsa.gov/guidebook/EPeerReviewOrgQA.jsp
Medical Record Access and Reporting
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Maryland Department of Health For your Information: Medical Records
https://health.maryland.gov/mbpme/Pages/records.aspx
Maryland Record Retention and fees FAQs
https://www.mbp.state.md.us/resource_information/faqs/resource_faqs_medical_
records.aspx
Maryland Code, Health-General 4-304 https://codes.findlaw.com/md/healthgeneral/md-code-health-gen-sect-4-304.html
CMS 2021 Medicare Promoting Interoperability Program: Certified Electronic
Health Record Technology Fact Sheet https://www.cms.gov/files/document/2021cehrt-fact-sheet.pdf
Federal Rule 502 Attorney-Client Privilege and Work Product
https://sterlingmiller2014.wordpress.com/2019/06/05/ten-things-a-primer-on-thework-product-privilege/
Maryland Rule 2-402 Scope of Discovery
https://sterlingmiller2014.wordpress.com/2019/06/05/ten-things-a-primer-on-thework-product-privilege/
The Work Product Doctrine https://content.next.westlaw.com/1-5018810?__lrTS=20210326135741218&transitionType=Default&contextData=(sc.De
fault)&firstPage=true
Ten Things: A Primer on the Work Product Privilege
https://sterlingmiller2014.wordpress.com/2019/06/05/ten-things-a-primer-on-thework-product-privilege/
HIPAA and medical record release
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HIPAA Medical Records Access https://www.hhs.gov/hipaa/forindividuals/medicalrecords/index.html#:~:text=Only%20you%20or%20your%20personal,payment%2
0or%20with%20your%20permission.
HIPAA and Research https://www.hhs.gov/hipaa/for-professionals/specialtopics/research/index.html
Special Topics in Health Information Privacy https://www.hhs.gov/hipaa/forprofessionals/special-topics/index.html
Employers and Health Information in the Workplace
https://www.hhs.gov/hipaa/for-individuals/employers-health-informationworkplace/index.html
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HIPAA and family members and friends https://www.hhs.gov/hipaa/forindividuals/family-members-friends/index.html
HIPAA Court Orders and Subpoenas https://www.hhs.gov/hipaa/forindividuals/court-orders-subpoenas/index.html
HIPAA and your medical records https://www.hhs.gov/hipaa/forindividuals/medical-records/index.html
HIPAA Patient Rights to Access information https://www.hhs.gov/hipaa/forindividuals/guidance-materials-for-consumers/index.html
Hospital Emergency Room and EMTALA
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ACEP EMTALA Fact Sheet https://www.acep.org/life-as-a-physician/ethics-legal/emtala/emtala-factsheet/#:~:text=The%20Emergency%20Medical%20Treatment%20and,has%20re
mained%20an%20unfunded%20mandate.
EMTALA Law https://www.law.cornell.edu/uscode/text/42/1395dd
Medicare Conditions of Participation Hospitals Patient Rights 42 C.F.R. 482.13
https://www.law.cornell.edu/cfr/text/42/482.13
ACEP EMTALA Fact Sheet https://www.acep.org/life-as-a-physician/ethics-legal/emtala/emtala-fact-sheet/
CMS State Operations Manual Appendix V – Interpretive Guidelines –
Responsibilities of Participating Hospitals in Emergency cases
https://www.cms.gov/Regulations-andGuidance/Guidance/Manuals/downloads/som107ap_v_emerg.pdf
CMS S & C-02-34 On-Call Requirements EMTALA
https://www.cms.gov/regulations-andguidance/legislation/emtala/downloads/sc0234pdf
Derlet, R. and Richards, J. Ten Solutions to Emergency Department Crowding.
West. J. Emerg. Med. 2008 Jan, 9(1): 24-27
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2672221/
Patient Safety, Quality Improvement and Risk Management
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Joint Commission Patient Safety Resources
https://www.jointcommission.org/resources/patient-safety-topics/patient-safety/
Hughes, R. Tools and Strategies for Quality Improvement and Patient Safety.
https://www.ncbi.nlm.nih.gov/books/NBK2682/
FMP Care Management Tools (Includes checklists, letters, forms, for office use)
https://www.aafp.org/fpm/toolBox/viewToolType.htm?toolTypeId=2
Management of Non-Complaint Patients. Medical Protective: Clinical Risk
Management Department. (Oct. 2013)
https://www.server5.medpro.com/documents/11006/16738/Management+of+Non
compliant+Patients+Guideline_10-2013.pdf
•
KootenaiHealth Involuntary Detention, Leaving Against Medical Device
https://www.kh.org/involuntary-detention-discharge-against-medical-advicemandatory-reporter/
Advanced Directives
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Maryland Health Care Decisions Act
https://www.marylandattorneygeneral.gov/Pages/HealthPolicy/hcda.aspx
Maryland Advanced Directives
https://www.marylandattorneygeneral.gov/Pages/HealthPolicy/AdvanceDirectives
.aspx
POLST Orders https://polst.org/
COMAR 10.01.21.04 Use of the MOLST Form (Maryland)
http://mdrules.elaws.us/comar/10.01.21.04
Maryland Medical Orders for Life Sustaining Treatment (MOLST) Maryland’s
Medical Orders for Life-Sustaining Treatment (MOLST) Form | Nolo
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Maryland State Advisory Council on Quality Care at the End of Life
https://www.marylandattorneygeneral.gov/Pages/HealthPolicy/sac.aspx
Maryland Health Decisions Policy
https://www.marylandattorneygeneral.gov/Pages/HealthPolicy/eolcare.aspx
Beginning and End of Life Decision Making
•
Elson, N., et. al. Getting Real: The Maryland Heatlhcare Ethics Committee
Network’s COVID-19 working group debriefs lessons learned. HEC Forum. 2021
June 33 (1-2):91-107 doi: 10.1007/s10730-021-09442-y
https://pubmed.ncbi.nlm.nih.gov/33582886/
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•
Ethics Consultations: AMA Code of Medical Ethics Opinion 10.7.1
https://www.ama-assn.org/delivering-care/ethics/ethicsconsultations#:~:text=The%20goal%20of%20ethics%20consultation,and%20the
%20health%20care%20team.&text=Seek%20to%20balance%20the%20concern
s,the%20patient’s%20needs%20and%20values.
Howe, E. Mediation Approaches at the Beginning or End of Life. The Journal of
Clinical Ethics. 26(4) (Winter 2015): pp. 275-85. Mediation Approaches at the
Beginning or End of Life – PubMed (nih.gov)
•
Sanderson, C. et. al. Patient-centered family meetings in palliative care: a quality
improvement project to explore a new model of family meetings with patients and
families at end of life. Ann. Palliat. Med. (2017) Dec 6 (suppl 2):S195-S205, doi:
doi: 10.21037/apm.2017.08.11 https://pubmed.ncbi.nlm.nih.gov/29156901/
Futile Care
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Clark, P. Medical Futility: Legal and Ethical Analysis. AMA Journal Of Ethics
(May 2007) https://journalofethics.ama-assn.org/article/medical-futility-legal-andethical-analysis/2007-05
Baby K Case https://casetext.com/case/matter-of-baby-k
Futile Care https://www.patientsrightscouncil.org/site/futile-care/
Abortion Law
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•
Maryland Abortion Laws https://statelaws.findlaw.com/maryland-law/marylandabortion-laws.html
Whole Woman’s Health v. Hellerstedt, (U.S. Supreme Court, 2016)
https://www.oyez.org/cases/2015/15-274
Stem Cell Laws
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NIH Guidelines for Human Stem Cell Research
https://stemcells.nih.gov/policy/2009-guidelines.htm
NIH Stem Cell Basics Stem Cell Basics | STEM Cell Information (nih.gov)
NIH Human Subjects Research Overview
https://www.nidcr.nih.gov/research/human-subjects-research
NIH Human Subjects Research Policies and Policy Notices
https://grants.nih.gov/policy/humansubjects/policies-and-regulations/researchguide-notice.htm
Institutional Review Board (IRB) Written Procedures: Guidance for Institutions
and IRBs https://www.hhs.gov/ohrp/regulations-and-policy/requests-forcomments/guidance-for-institutions-and-irbs/index.html
Ethical Codes
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•
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AMA Code of Ethics Overview https://www.ama-assn.org/deliveringcare/ethics/code-medical-ethics-overview
American College of Healthcare Executives (ACHE) Code of Ethics
https://www.ache.org/about-ache/our-story/our-commitments/ethics/ache-codeof-ethics
AMA code of Medical Ethics Opinion 7 .3.8 Research with stem cells
https://www.ama-assn.org/delivering-care/ethics/research-stem-cells
Health Care Compliance Association (HCCA) Code of Ethics for Health Care
Compliance Professionals https://www.hcca-info.org/code-ethics-health-carecompliance-professionals
American Health Information Management Association (AHIMA) Code of Ethics
http://bok.ahima.org/doc?oid=105098#.YJmhrLVKiUl
American College of Emergency Room Physicians (ACEP) Code of Ethics ACEP //
Code of Ethics for Emergency Physicians
Chapter 12
Copyright 2020. ACHE Management Series.
All rights reserved. May not be reproduced in any form without permission from the publisher, except fair uses permitted under U.S. or applicable copyright law.
Baby Charlie and
End-of-Life Decisions
Case Stu d y
“Baby Charlie” died on July 28, 2017. His death made international news, much
as his life did. Charlie’s mother said that her son “had a greater impact on and
touched more people in this world in his 11 months than many people do in a
lifetime” (Bilefsky 2017). The dramatic events surrounding the end of Charlie’s life
captured the attention of people worldwide, including the pope and the president
of the United States.
Charlie Gard was born in London, England, on August 4, 2016, and he appeared to
be a healthy baby. In his first months, however, he failed to gain weight and was unable
to lift his head or support himself as normal. On October 11, he was admitted to Great
Ormond Street Hospital in London. There, he was diagnosed with mitochondrial DNA
depletion syndrome—a rare, debilitating, and fatal genetic condition that left him on
life support with irreversible brain damage for months. Soon, Charlie was unable to
see, swallow, or move his arms or legs, and he showed no usual signs of brain activity, responsiveness to pain or pleasure, or crying. The medical team could not tell if
Charlie was awake or asleep, and seizures became common. It was the “assessment
of the medical team at Great Ormond Street Hospital that further treatment was futile
and that palliative care should be pursued” (Hammond-Browning 2017, 462).
Charlie’s parents, Chris Gard and Connie Yates, did not agree with this medical
assessment, and they fought long and hard to control their son’s life and, later, the
terms of his death. What Charlie’s parents wanted for him differed from what the
medical team believed to be the right course of action, and a legal battle ensued,
first in the British courts and eventually in the European Court of Human Rights.
The European Court backed the hospital’s opinion, “in part because experts said
Charlie could be suffering” (Bilefsky 2017).
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Much of the battle surrounded the parents’ desire for Charlie to have an
experimental treatment known as nucleoside therapy, which had not yet been
tried on anyone with Charlie’s diagnosis or debilitation. The parents had spoken
with Dr. Michio Hirano, a neurologist at Columbia University Medical Center in
New York, who said there was a “theoretical possibility” that the treatment could
be of benefit to Charlie (Hammond-Browning 2017). Dr. Hirano indicated, however, that severe brain involvement was a contraindication to the use of nucleoside therapy.
The Great Ormond Street Hospital prepared a referral to the hospital’s ethics
committee to examine the ethical implications of using the experimental treatment. However, before the committee could meet, Charlie developed intermittent
seizures and severe epileptic encephalopathy. The hospital’s medical team decided
that nucleoside was no longer a viable treatment option and would only serve to
prolong Charlie’s suffering (Hammond-Browning 2017).
The parents continued their fight by trying to take Charlie to the United States
for nucleoside treatment. They used social media to seek funding and raised more
than £1.3 million—the equivalent of more than $1.6 million. Funding for the treatment became a point of contention. The hospital insisted that funding was not the
issue, but much of the public following the case was skeptical. In court, one medical expert testified that the United States and the United Kingdom had a difference
in philosophy. She stated that, in the United States, any medical treatment will be
attempted as long as funding is available, whereas her approach was centered on
the best interests of the patient (Hammond-Browning 2017).
The court-appointed guardian for Charlie argued that nucleoside therapy was
not in Charlie’s best interest and that it was not a lifesaving treatment, but merely
experimental. The judge agreed and ruled in favor of the hospital, declaring that
the hospital could discontinue artificial ventilation and provide palliative care only
(Hammond-Browning 2017). The parents then filed appeals.
In court, the lawyers for Great Ormond Street Hospital argued that Dr. Hirano
had never examined Charlie and therefore did not have the benefit of his full medical record. Later, when Dr. Hirano traveled to London to examine Charlie, he determined that further treatment would be futile. The parents argued the hospital had
delayed the treatment until it was too late (Bilefsky 2017).
The experimental treatment was now out of the question, but the legal battle
over the end of Charlie’s life continued. The parents wanted to take Charlie home
to die, but the hospital’s medical team argued that the “risk of an unplanned and
chaotic end to Charlie’s life” while living at home was “unthinkable” (Bilefsky 2017).
This heated and often acrimonious legal dispute was still ongoing when Baby
­Charlie died at the age of 11 months and 24 days. He had been on life support for
the majority of his life (Bilefsky 2017).
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As these emotional legal battles took place in the courts, heated debates spread
widely over Facebook, Twitter, and other social media. Supporters of both the hospital’s and the parents’ viewpoints offered religious and political arguments, and
experts in the fields of medicine, ethics, academia, research, and the law published
their opinions. Past discussions of end-of-life decisions, assisted suicide, and death
with dignity were resurrected, and parental rights and socialized medicine became
renewed topics of political controversy. Pro-life advocates joined in the zealous
fight. Crowds of protestors lined the streets outside of the hospital; some hospital
staff even faced death threats (Bilefsky 2017). A powerful symbol for humanity, Baby
Charlie Gard engendered significant, weighty questions—some of which society
has yet to answer definitively.
Eth ics Issu es
Patients’ rights: Does a patient’s bill of rights give patients—or, in the case of
minors, parents and guardians—the right to select their treatment and make
end-of-life decisions within a healthcare facility? Are extreme life-support measures more warranted for young people than for adults?
Experimental treatment: Can patients—or, in the case of minors, parents and
guardians—demand and receive experimental treatment against the wishes of the
medical team? Is it ethical for researchers to suggest the efficacy of experimental
treatments that have not been proven to be beneficial in human subjects? Is it
ethical to advance research objectives while offering false hope to people who are
suffering?
Cultural competency: Should healthcare professionals respect and adhere to
patients’ and families’ cultural traditions and religious beliefs about end-of-life
decisions if those traditions and beliefs are in conflict with professional codes of
conduct? How can healthcare professionals reconcile personal values with patient
interest or values when a conflict occurs?
Management’s role and responsibility: What is the ethical responsibility of man-
agement to uphold the healthcare organization’s mission, values, and codes of
conduct? What is management’s ethical and financial responsibility to the public
and the community served?
Organizational implications: Does the organization have the infrastructure in
place to deal with major ethical decisions? What are the organizational implications of management actions related to end-of-life decisions for patients under
its care—especially children? How will management actions be perceived by the
public, and what impact might they have on community image and support?
Chapter 12: Baby Charlie and End-of-Life Decisions
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Impact of the media: What is the impact of the media on healthcare services and
delivery? On lifestyle choices and health? On public trust in healthcare institutions? How did media coverage of the Charlie Gard case influence events over
the course of Charlie’s hospitalization and treatment? Did it affect any outcomes?
Ethical responsibilities to employees: How will management actions affect staff
morale, staff productivity, and staff perceptions of management? What is the
ethical responsibility of management to provide a safe work environment for
employees? To provide counseling and support for employees? To provide training in communication skills and conflict management?
Political implications: How do end-of-life decisions fuel the debate between
right-to-die advocates and opponents? Between pro-life advocates and opponents? Do the events of this case contest or support the idea of universal
­healthcare?
Legal Implications: What are the hospital’s liability and course of action when
patients—or, in the case of minors, parents or guardians—demand care or
treatment that the medical team disagrees with and refuses to provide? Is the
hospital legally liable for a hostile work environment when employees receive
threats from the public? What is the hospital’s liability when patients are given
unproven experimental therapy?
Discu ss ion
Although the tragic events surrounding Baby Charlie took place in the United
Kingdom, these same healthcare challenges occur in the United States. Medical
decisions, human interactions, conflicting demands, and patient suffering test all
healthcare professionals, regardless of the differences between the two nations’
healthcare systems. Therefore, important lessons can be learned. This discussion
will focus on circumstances relevant to the US healthcare system.
Patients’ Rights­
In the United States, patients have certain rights that are protected by federal and/
or state law or guaranteed by healthcare organizations and accrediting and licensure agencies. These rights are often compiled into a document called a “patient’s
bill of rights,” though the specific wording varies from one hospital to another
(ABC Law Centers 2017).
A patient’s bill of rights differs from a consent form. A consent form is a
legal document signed by patients or legal guardians agreeing to undergo medical
treatment. It indicates that people signing have been informed of the treatment,
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its risks, and its viable options and have decided to undergo the procedure. A
patient’s bill of rights guarantees that patients or legal guardians are provided with
the necessary treatment information prior to giving their consent. Thus, a patient’s
bill of rights ensures that legally binding “informed consent” occurs (ABC Law
Centers 2017). This issue is especially significant when treatment decisions being
considered during life-threatening situations or when the treatment is high risk or
may produce severe adverse reactions.
Nowhere are treatment decisions more fraught with emotion, doubt, and
controversy than during end-of-life discussions. Controversy over such decisions
is common among family members or, as in the case of Baby Charlie, between
family members and the medical team. And nowhere are these decisions more
emotional and heart wrenching than in cases involving children.
Healthcare professionals must be prepared for these decisions. They must
be skilled communicators, able to ascertain that facts and realistic expectations
of the patient’s condition and prognosis have been made clear to the people
responsible for end-of-life decisions. Healthcare management must work closely
with medical and nursing staff to ensure that they provide accurate, understandable information to patients and are persuasive in advocating for the patients’
best interests. All healthcare professionals must operate within the mission and
values of the organization and within their own professional ethical codes of
conduct. Doing so is a tall task. Sometimes, the demands of the patient—or,
in the case of Baby Charlie, the parents—are irreconcilable with medical staff
recommendations.
In such cases, patients and guardians need to be well informed of their rights.
Respected healthcare organizations will refer patients or families struggling with
these decisions to useful resources such as patient representatives, ethics committees, counseling services, and support groups. Some or all of these resources are
available in most hospitals. These resources can be especially useful in explaining
the patient’s bill of rights to patients or guardians.
Do patients—or, in the case of minors, parents or guardians—have the right
to select their treatment and make end-of-life decisions within a healthcare facility? A list of patient rights from The Joint Commission (2019) includes “the right
to make decisions about your care,” “the right to refuse care,” and “the right to be
listened to.” However, a hospital is not necessarily required to provide care that
is determined to not be medically necessary or appropriate. Patients or their legal
representatives must be actively involved in care decisions and should speak up
about what they desire. Furthermore, nursing staff must advocate for the patient
and make the patient’s or guardian’s desires known to the people in authority—
even if those desires are in conflict with the personal or professional values and
beliefs of the nursing staff.
Chapter 12: Baby Charlie and End-of-Life Decisions
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Making certain that patients or their legal representatives are actively involved
in the decision-making about care and treatment is a serious responsibility for
healthcare professionals—one that management also must be attentive to. Doctors
and nurses have a legal obligation to ensure that patients or their legal representatives have been apprised of their rights and have received the necessary information to give informed consent before a course of treatment. If they fail to do so
and the patient suffers as a result, the doctors and nurses may be guilty of medical
malpractice, and they—and the healthcare facility—may be subject to litigation
(ABC Law Centers 2017).
Experim…