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 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. 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 21 EBSCO Publishing : eBook Collection (EBSCOhost) - printed on 7/6/2022 2:48 PM via UNIVERSITY OF MARYLAND GLOBAL CAMPUS AN: 2344970 ; Frankie Perry.; The Tracks We Leave: Ethics and Management Dilemmas in Healthcare, Third Edition Account: s4264928.main.edsebook 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 22 Part II: Case Studies and Moral Challenges EBSCOhost - printed on 7/6/2022 2:48 PM via UNIVERSITY OF MARYLAND GLOBAL CAMPUS. All use subject to https://www.ebsco.com/terms-of-use 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 Chapter 3: Medical Errors: Paradise Hills Medical Center EBSCOhost - printed on 7/6/2022 2:48 PM via UNIVERSITY OF MARYLAND GLOBAL CAMPUS. All use subject to https://www.ebsco.com/terms-of-use 23 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 24 Part II: Case Studies and Moral Challenges EBSCOhost - printed on 7/6/2022 2:48 PM via UNIVERSITY OF MARYLAND GLOBAL CAMPUS. All use subject to https://www.ebsco.com/terms-of-use 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 Chapter 3: Medical Errors: Paradise Hills Medical Center EBSCOhost - printed on 7/6/2022 2:48 PM via UNIVERSITY OF MARYLAND GLOBAL CAMPUS. All use subject to https://www.ebsco.com/terms-of-use 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. 26 Part II: Case Studies and Moral Challenges EBSCOhost - printed on 7/6/2022 2:48 PM via UNIVERSITY OF MARYLAND GLOBAL CAMPUS. All use subject to https://www.ebsco.com/terms-of-use 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. Chapter 3: Medical Errors: Paradise Hills Medical Center EBSCOhost - printed on 7/6/2022 2:48 PM via UNIVERSITY OF MARYLAND GLOBAL CAMPUS. All use subject to https://www.ebsco.com/terms-of-use 27 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. 28 Part II: Case Studies and Moral Challenges EBSCOhost - printed on 7/6/2022 2:48 PM via UNIVERSITY OF MARYLAND GLOBAL CAMPUS. All use subject to https://www.ebsco.com/terms-of-use • • • • • • 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. Chapter 3: Medical Errors: Paradise Hills Medical Center EBSCOhost - printed on 7/6/2022 2:48 PM via UNIVERSITY OF MARYLAND GLOBAL CAMPUS. All use subject to https://www.ebsco.com/terms-of-use 29 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 30 Part II: Case Studies and Moral Challenges EBSCOhost - printed on 7/6/2022 2:48 PM via UNIVERSITY OF MARYLAND GLOBAL CAMPUS. All use subject to https://www.ebsco.com/terms-of-use 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 Chapter 3: Medical Errors: Paradise Hills Medical Center EBSCOhost - printed on 7/6/2022 2:48 PM via UNIVERSITY OF MARYLAND GLOBAL CAMPUS. All use subject to https://www.ebsco.com/terms-of-use 31 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 32 Part II: Case Studies and Moral Challenges EBSCOhost - printed on 7/6/2022 2:48 PM via UNIVERSITY OF MARYLAND GLOBAL CAMPUS. All use subject to https://www.ebsco.com/terms-of-use 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. Chapter 3: Medical Errors: Paradise Hills Medical Center EBSCOhost - printed on 7/6/2022 2:48 PM via UNIVERSITY OF MARYLAND GLOBAL CAMPUS. All use subject to https://www.ebsco.com/terms-of-use 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 34 Part II: Case Studies and Moral Challenges EBSCOhost - printed on 7/6/2022 2:48 PM via UNIVERSITY OF MARYLAND GLOBAL CAMPUS. All use subject to https://www.ebsco.com/terms-of-use 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. Chapter 3: Medical Errors: Paradise Hills Medical Center EBSCOhost - printed on 7/6/2022 2:48 PM via UNIVERSITY OF MARYLAND GLOBAL CAMPUS. All use subject to https://www.ebsco.com/terms-of-use 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. 36 Part II: Case Studies and Moral Challenges EBSCOhost - printed on 7/6/2022 2:48 PM via UNIVERSITY OF MARYLAND GLOBAL CAMPUS. All use subject to https://www.ebsco.com/terms-of-use 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? Chapter 3: Medical Errors: Paradise Hills Medical Center EBSCOhost - printed on 7/6/2022 2:48 PM via UNIVERSITY OF MARYLAND GLOBAL CAMPUS. All use subject to https://www.ebsco.com/terms-of-use 37 • • • • • • 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 38 Part II: Case Studies and Moral Challenges EBSCOhost - printed on 7/6/2022 2:48 PM via UNIVERSITY OF MARYLAND GLOBAL CAMPUS. All use subject to https://www.ebsco.com/terms-of-use 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. Chapter 3: Medical Errors: Paradise Hills Medical Center EBSCOhost - printed on 7/6/2022 2:48 PM via UNIVERSITY OF MARYLAND GLOBAL CAMPUS. All use subject to https://www.ebsco.com/terms-of-use 39 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 40 Part II: Case Studies and Moral Challenges EBSCOhost - printed on 7/6/2022 2:48 PM via UNIVERSITY OF MARYLAND GLOBAL CAMPUS. All use subject to https://www.ebsco.com/terms-of-use 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). Referenc es 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/. Chapter 3: Medical Errors: Paradise Hills Medical Center EBSCOhost - printed on 7/6/2022 2:48 PM via UNIVERSITY OF MARYLAND GLOBAL CAMPUS. All use subject to https://www.ebsco.com/terms-of-use 41 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 commentary. Published May 17. www.iom.edu/Global/Perspectives/2013/ RightToKnow.aspx. Goedert, J. 2012. “Study Pegs Cost of Medical Errors Near $1 Trillion Annually.” HealthData Management. Published October 19. www.healthdatamanagement. com/news/medical-errors-economic-cost-study-hospitals-45134-1.html. Greider, K. 2012. “The Worst Place to Be If You’re Sick.” AARP Bulletin. Published March. http://pubs.aarp.org/aarpbulletin/201203_DC?pg=10. Hébert, P. C., E. M. Meslin, and E. V. Dunn. 1992. “Measuring the Ethical Sensitivity of Medical Students: A Study at the University of Toronto.” Journal of Medical Ethics 18 (3): 142–47. Iezzoni, L. I., S. R. Rao, C. M. DesRoches, C. Vogeli, and E. G. Campbell. 2012. “Survey Shows That at Least Some Physicians Are Not Always Open or Honest with Patients.” Health Affairs 31 (2): 383–91. Kohn, L. T., J. M. Corrigan, and M. S. Donaldson (eds.). 1999. To Err Is Human: Building a Safer Health System. Washington, DC: National Academies Press. Kraman, S. S., and G. Hamm. 1999. “Risk Management: Extreme Honesty May Be the Best Policy.” Annals of Internal Medicine 131 (12): 913–67. Kübler-Ross, E. 1969. On Death and Dying. New York: Macmillan Publishing Co. Leapfrog Group. 2019. “Errors, Injuries, Accidents, Infections.” Leapfrog Hospital Safety Grade. Updated May 14. www.hospitalsafetygrade.org/what-is-patientsafety/errors-injuries-accidents-infections. 42 Part II: Case Studies and Moral Challenges EBSCOhost - printed on 7/6/2022 2:48 PM via UNIVERSITY OF MARYLAND GLOBAL CAMPUS. All use subject to https://www.ebsco.com/terms-of-use Makary, M. 2012. Unaccountable: What Hospitals Won’t Tell You and How Transparency Can Revolutionize Health Care. New York: Bloomsbury Press. Morreim, E. 2000. “Ethical Imperatives of Medical Errors.” Healthcare Executive 15 (4): 56–57. Murphy, E. C. 2013. “Why Do Healthcare Executives Fail?” Murphy Leadership Partners. Accessed May 8. www.murphyleadership.com/on-demand-webinars. O’Reilly, K. B. 2012a. “Fear of Punitive Response to Hospital Errors Lingers.” American Medical News. Published February 20. www.amednews.com/ article/20120220/profession/302209938/2/. ———. 2012b. “Medicare’s No-Pay Rule Sharpens Infection-Control Efforts.” American Medical News. Published May 14. www.amednews.com/article/20120514/ profession/305149943/6/. ———. 2008. “No Pay for ‘Never Events’ Becoming Standard.” American Medical News. Published January 7. www.amednews.com/article/20080107/profession/301079966/7/. Peck, C. 2012. “Better Hospital–Physician Partnerships.” Hospitals & Health Networks Daily. Published April 5. www.hhnmag.com/hhnmag/HHNDaily/ HHNDailyDisplay.dhtml?id=9270008713. Pilla, L. 2000. “Clinton Introduces Plan to Reduce Medical Errors.” Nurses.com. Published February 22. www.nurses.com/doc/Clinton-Introduces-Plan-to-ReduceMedical-Err-0001. Quality Interagency Coordination Task Force. 2000. Doing What Counts for Patient Safety: Federal Actions to Reduce Medical Errors and Their Impact. Accessed April 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 Reporting Systems Do Not Capture Most Patient Harm.” Published January. https://oig.hhs.gov/oei/reports/oei-06-09-00091.pdf. Wagner, K. 2019. “Executing on Your Safety Priorities.” Healthcare Executive 34 (2): 17–23. Chapter 3: Medical Errors: Paradise Hills Medical Center EBSCOhost - printed on 7/6/2022 2:48 PM via UNIVERSITY OF MARYLAND GLOBAL CAMPUS. All use subject to https://www.ebsco.com/terms-of-use 43 EBSCOhost - printed on 7/6/2022 2:48 PM via UNIVERSITY OF MARYLAND GLOBAL CAMPUS. All use subject to https://www.ebsco.com/terms-of-use 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 • • 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 • • • • 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 • • • • 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) • • 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 • • • 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 • • 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 • • • • • • 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 • • • • • • • • 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 • 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 • OSHA Workplace Violence Workplace Violence - Overview | Occupational Safety and Health Administration (osha.gov) • • • • • • 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 • • • 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 https://cmscompliancegroup.com/2013/06/24/24-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) • AHRQ Long Term Care Facility – Patient Safety Tools https://www.ahrq.gov/patient-safety/resources/pstools/index.html#facilities • • 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) • The Healthcare Quality Improvement Act (HCQIA) 42 U.S. Code § 11101 - Findings | U.S. Code | US Law | LII / Legal Information Institute (cornell.edu) • • • • 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) • • • • • • 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) • • • 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 • • • • • • • • 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 • • • • 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 • • • • 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 • • • • • • • 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 • • • • 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 • • • • • 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 • • 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/ • • 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 • • • 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 • • 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 • • • • • 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 • • • • • • 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). 171 EBSCO Publishing : eBook Collection (EBSCOhost) - printed on 11/20/2022 7:10 PM via UNIVERSITY OF MARYLAND GLOBAL CAMPUS AN: 2344970 ; Frankie Perry.; The Tracks We Leave: Ethics and Management Dilemmas in Healthcare, Third Edition Account: s4264928.main.edsebook 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). 172 Part II: Case Studies and Moral Challenges EBSCOhost - printed on 11/20/2022 7:10 PM via UNIVERSITY OF MARYLAND GLOBAL CAMPUS. All use subject to https://www.ebsco.com/terms-of-use 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 173 EBSCOhost - printed on 11/20/2022 7:10 PM via UNIVERSITY OF MARYLAND GLOBAL CAMPUS. All use subject to https://www.ebsco.com/terms-of-use 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, 174 Part II: Case Studies and Moral Challenges EBSCOhost - printed on 11/20/2022 7:10 PM via UNIVERSITY OF MARYLAND GLOBAL CAMPUS. All use subject to https://www.ebsco.com/terms-of-use 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 175 EBSCOhost - printed on 11/20/2022 7:10 PM via UNIVERSITY OF MARYLAND GLOBAL CAMPUS. All use subject to https://www.ebsco.com/terms-of-use 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...