Social Science

6Medical Mistakes and Patient Safety

Flirt/SuperStock

Learning Objectives

After reading this chapter, you should be able to

1. Explain reasons for the prevalence of medical mistakes.

2. Describe mistakes that threaten patient safety.

3. Analyze how ethical health care organizations address the vexing problem of medical mistakes.

4. Examine the legal, regulatory, political, and administrative attempts to reduce threats to patient safety.

5. Understand tort law and what is meant by tort reform.

6. Examine the ethical implications of health care organizations’ responses to medical mistakes.

7. Comprehend the significance of landmark legal cases that shape the current climate of quality improvement and risk management.

© 2019 Bridgepoint Education, Inc. All rights reserved. Not for resale or redistribution.

Section 6.1The Extent of Medical Mistakes

Introduction In this chapter we will analyze how ethical health care organizations address the serious problem of medical mistakes. We will also take an in-depth look at some legal, regulatory, political, and administrative solutions that may lessen the risk to patients while also protect- ing organizations from legal liability. Throughout this chapter we will also explore the ethical implications of this issue and how an awareness of the ultimate ends of health care can yield practical solutions.

6.1 The Extent of Medical Mistakes Until 1999, most Americans were unaware of the extent of medical errors in health care. That year, the Institute of Medicine (IOM) released the report “To Err Is Human: Building a Safer Health System” (IOM, 1999). Based on a series of studies, “To Err Is Human” concluded that up to 100,000 people die from preventable medical errors every year in the United States (IOM, 1999). The shocking statistic thoroughly shook the collective trust in American health care. Another IOM report, published in 2001 and titled “Crossing the Quality Chasm,” furthered the point that health risks to patients from health care providers due to preventable human errors were much too high. (See Figure 6.1 for a comparison of the percentage of medical errors made in various countries.)

Figure 6.1: Medical, medication, or lab test errors, 2009–2011

This graph compares the percentage of medical errors made in various countries. Why do you think that the United States has the highest percentage of medical errors of the seven countries listed?

Source: Schoen, C., Osborn, R., Squires, D., Doty, M. M., Pierson, R. & Applebaum, S. (2011). New 2011 survey of patients with complex care needs in 11 countries finds that care is often poorly coordinated. Health Affairs. Data retrieved from https://www .commonwealthfund.org/chart/medical-medication-or-lab-test-errors-past-two-years

Case Study: A Tragic Medical Mistake

In early December of 1995, a seven-year-old boy was admitted to a South Florida hospital to undergo ear surgery to remove scar tissue resulting from two earlier surgeries. Although the young boy was frightened, his mother played with him beforehand and ensured him he would be fine and would even have an early Christmas surprise when he woke up from the surgery.

During the surgery, the boy would be under general anesthesia, and his ear would be injected with lidocaine and swabbed with a form of adrenaline called epinephrine. The pro- cedure used to prepare each of these drugs for use in surgery occurs frequently and without error in hospitals all over the country. Unfortunately, on this day, a mistake occurred and the two drugs were inadvertently switched. Instead of injecting the patient with lidocaine, the physician administered a lethal dose of epinephrine directly into the boy’s ear. This immediately caused the boy’s heart rate and blood pressure to rise at an alarming rate. The head of anesthesia was rushed into the operating room (OR) to try and bring the boy’s heart rate and blood pressure down. He was able to temporarily stabilize the boy, but soon after the patient’s heart rate and blood pressure began rapidly decreasing, and then he stopped breathing. The head of anesthesia performed CPR on the patient for more than 90 minutes. While he was finally able to resuscitate the patient, it was evident that the boy was in a deep coma and would probably not recover. He was rushed to the intensive care unit and his mother was informed by the surgeon and the head of anesthesia that her son was in a coma and most likely brain dead. After keeping the boy on a ventilator for almost 24 hours, it was apparent to his parents and older sister that he was not going to regain consciousness. Therefore, the parents agreed to remove the ventilator, and the boy passed away.

The hospital’s risk manager was called in during the incident, and while the surgeons were speaking with the child’s parents, she went into the OR and collected everything that was left from that specific surgery. Initially, she decided to lock away all the syringes, vials, and cups that were used; however, once she received the details of the incident, she knew she had to send these items out to be tested by an independent lab. The risk manager promised the parents she would get to the bottom of what occurred during the surgery.

Three weeks after the boy’s death, the risk manager received the results of the independent test which were conclusive in showing that the drugs had been inadvertently switched and that the young boy had died due to human error. By this time, the family had hired malprac- tice attorneys. The risk manager and the head of anesthesia met with the family and their lawyers to share the results of the test and admit the truth. It was important to them and the entire hospital administration to admit this mistake to the grieving parents, determine what needed to be done to try and ease their pain, and work on a solution to ensure that such a mistake would never happen again.

An undisclosed settlement was made and the parents met with the surgeon to ask the ques- tions that had been troubling them since their son’s death. They wanted to know if their son had suffered, if he had known he was in trouble, and, surprisingly, if they could continue using the hospital for their medical care. They also wanted to share their son’s story with everyone who would listen to ensure the same mistake would not occur again in the future. At that point, the case was closed for the family; however, the case was far from closed for the hospital.

(continued on next page)

© 2019 Bridgepoint Education, Inc. All rights reserved. Not for resale or redistribution.

Section 6.1The Extent of Medical Mistakes

Introduction In this chapter we will analyze how ethical health care organizations address the serious problem of medical mistakes. We will also take an in-depth look at some legal, regulatory, political, and administrative solutions that may lessen the risk to patients while also protect- ing organizations from legal liability. Throughout this chapter we will also explore the ethical implications of this issue and how an awareness of the ultimate ends of health care can yield practical solutions.

6.1 The Extent of Medical Mistakes Until 1999, most Americans were unaware of the extent of medical errors in health care. That year, the Institute of Medicine (IOM) released the report “To Err Is Human: Building a Safer Health System” (IOM, 1999). Based on a series of studies, “To Err Is Human” concluded that up to 100,000 people die from preventable medical errors every year in the United States (IOM, 1999). The shocking statistic thoroughly shook the collective trust in American health care. Another IOM report, published in 2001 and titled “Crossing the Quality Chasm,” furthered the point that health risks to patients from health care providers due to preventable human errors were much too high. (See Figure 6.1 for a comparison of the percentage of medical errors made in various countries.)

Figure 6.1: Medical, medication, or lab test errors, 2009–2011

This graph compares the percentage of medical errors made in various countries. Why do you think that the United States has the highest percentage of medical errors of the seven countries listed?

Source: Schoen, C., Osborn, R., Squires, D., Doty, M. M., Pierson, R. & Applebaum, S. (2011). New 2011 survey of patients with complex care needs in 11 countries finds that care is often poorly coordinated. Health Affairs. Data retrieved from https://www .commonwealthfund.org/chart/medical-medication-or-lab-test-errors-past-two-years

Case Study: A Tragic Medical Mistake

In early December of 1995, a seven-year-old boy was admitted to a South Florida hospital to undergo ear surgery to remove scar tissue resulting from two earlier surgeries. Although the young boy was frightened, his mother played with him beforehand and ensured him he would be fine and would even have an early Christmas surprise when he woke up from the surgery.

During the surgery, the boy would be under general anesthesia, and his ear would be injected with lidocaine and swabbed with a form of adrenaline called epinephrine. The pro- cedure used to prepare each of these drugs for use in surgery occurs frequently and without error in hospitals all over the country. Unfortunately, on this day, a mistake occurred and the two drugs were inadvertently switched. Instead of injecting the patient with lidocaine, the physician administered a lethal dose of epinephrine directly into the boy’s ear. This immediately caused the boy’s heart rate and blood pressure to rise at an alarming rate. The head of anesthesia was rushed into the operating room (OR) to try and bring the boy’s heart rate and blood pressure down. He was able to temporarily stabilize the boy, but soon after the patient’s heart rate and blood pressure began rapidly decreasing, and then he stopped breathing. The head of anesthesia performed CPR on the patient for more than 90 minutes. While he was finally able to resuscitate the patient, it was evident that the boy was in a deep coma and would probably not recover. He was rushed to the intensive care unit and his mother was informed by the surgeon and the head of anesthesia that her son was in a coma and most likely brain dead. After keeping the boy on a ventilator for almost 24 hours, it was apparent to his parents and older sister that he was not going to regain consciousness. Therefore, the parents agreed to remove the ventilator, and the boy passed away.

The hospital’s risk manager was called in during the incident, and while the surgeons were speaking with the child’s parents, she went into the OR and collected everything that was left from that specific surgery. Initially, she decided to lock away all the syringes, vials, and cups that were used; however, once she received the details of the incident, she knew she had to send these items out to be tested by an independent lab. The risk manager promised the parents she would get to the bottom of what occurred during the surgery.

Three weeks after the boy’s death, the risk manager received the results of the independent test which were conclusive in showing that the drugs had been inadvertently switched and that the young boy had died due to human error. By this time, the family had hired malprac- tice attorneys. The risk manager and the head of anesthesia met with the family and their lawyers to share the results of the test and admit the truth. It was important to them and the entire hospital administration to admit this mistake to the grieving parents, determine what needed to be done to try and ease their pain, and work on a solution to ensure that such a mistake would never happen again.

An undisclosed settlement was made and the parents met with the surgeon to ask the ques- tions that had been troubling them since their son’s death. They wanted to know if their son had suffered, if he had known he was in trouble, and, surprisingly, if they could continue using the hospital for their medical care. They also wanted to share their son’s story with everyone who would listen to ensure the same mistake would not occur again in the future. At that point, the case was closed for the family; however, the case was far from closed for the hospital.

(continued on next page)

© 2019 Bridgepoint Education, Inc. All rights reserved. Not for resale or redistribution.

Section 6.1The Extent of Medical Mistakes

Reducing Foreseeable Risks Over the past several decades, health care providers have devoted significant attention to addressing the problem of medical errors. Nonetheless, errors that endanger patients per- sist. According to a 2010 study, there were 35 reported cases of wrong-site craniotomies in the United States prior to the time of the study (Cohen, Mendelsohn, & Bernstein, 2010). The study found that there were four major categories of contributing factors to wrong-site cra- niotomies: (a) communication breakdown, (b) inadequate preoperative checks, (c) technical factors and imaging, and (d) human error. All of these factors boil down to human errors that stem from violating multiple fail-safes intended to prevent such mistakes. In the majority of cases, this is a result of a breach in policy, guidelines, or protocol. Since there are usually sev- eral different lines of redundant checks, each error often represents multiple breaches.

For example, 53-year-old Regina Turner was admitted to a respected hospital in St. Louis, Missouri, for a common brain surgery known as a craniotomy bypass (Doyle, 2013). A

Case Study: A Tragic Medical Mistake (continued)

The risk manager, CEO, head of anesthesia, and, at times, even the surgeon, traveled to con- ferences around the country to share the story of what had happened in their OR that day. As the story spread, the group was invited to speak at more and more conferences, both in the U.S. and, eventually, abroad. A group of physicians from Japan even traveled to the hospital to discuss the case with those involved so they could better their own procedures in the OR.

In addition to sharing the story with other medical professionals, the hospital made many internal changes to their procedures. Drugs were no longer permitted to be poured from a bottle into a cup and transferred to a syringe; the new policy is to use a special filtering device to transfer the drugs directly to a syringe. In addition, the medicines are to be placed in the syringes one at a time to ensure that there is no chance of a mix-up. The entire pro- cess must be observed by two nurses who must also verify the contents. Lastly, all medical staff have been trained not to place epinephrine into a syringe or discard any vials until surgery is finished and patients are checked for complete stabilization.

This case study is about a true occurrence that was covered in international news for many years. You can read additional details on the case, what happened after, and how things have changed in health care due to this case in the following articles:

• “Diagnosing Medical Errors: In the Wake of Widely Publicized Mistakes, Doctors Try To Make Hospitals Safer”

• “Tragedy Teaches A Lesson: Sharing Data Saves Lives” • “How Can We Save the Next Victim?”

Discussion Questions

1. Should any of the individuals in the OR have been charged with a crime, such as negligence or involuntary manslaughter? If so, which individuals and why?

2. What, if any, disciplinary action(s) should the hospital take toward those involved in response to this incident?

© 2019 Bridgepoint Education, Inc. All rights reserved. Not for resale or redistribution.

Section 6.1The Extent of Medical Mistakes

preoperative photograph of the woman on her hospital bed shows an indelible mark on her left temple to mark the site of the surgery (Doyle, 2013). Such marks have become commonplace in hospitals as one in a long line of fail-safes to prevent wrong-site surgeries. In this case, how- ever, the obvious black mark did not work. The neurosurgeon and his team allegedly performed the craniotomy on the right hemisphere of her brain, and a postopera- tive photograph shows a patient with the bandages clearly on the right side of her head (Doyle, 2013). As a result of the botched surgery, a formerly walking and talking patient was now wheelchair bound and unable to speak clearly (Doyle, 2013).

The appropriate response to such an incident, though, is complicated. While a hospital may have an ethical obligation to reduce the risk of wrong-site surgeries to below some agreed- upon threshold (0.05%, for example), it is not clear that there is an ethical imperative to spend millions of additional dollars to reduce that risk by a small margin (to 0.045%, for example). This is especially true if the hospital could be accused of shirking the ethical prin- ciple of beneficence by ignoring other pressing needs in the process. Where should the line be drawn? Health care organizations must be pragmatic about marginal gains that cost dispro- portionately too much to achieve or may even be futile to pursue.

Iatrogenic Morbidity and Mortality Whenever a patient becomes inadvertently or unintentionally sick or injured during the course of receiving medical care, the result is called an iatrogenic injury. Morbidity indicates illness, while mortality refers to the death of the patient. Iatrogenic morbidity and mortality do not necessarily result from medical errors or negligence. Morbidity or mortality may be produced by foreseeable incidents related to treatment. They can also result from complica- tions or adverse reactions that could not be prevented. Often, however, the iatrogenic injury could and should have been prevented.

The principle of nonmaleficence—minimizing unnecessary risks and avoiding preventable harm—imposes an ethical duty on health care professionals to minimize unnecessary risks and avoid preventable harms. Other industries can offer ideas about how to reduce the risk of harm due to human error. For example, in the 2007 New Yorker article “The Checklist,” sur- geon Atul Gawande detailed how the aviation industry has created pilot checklists that item- ize tasks to be completed before takeoff, flight, landing, and taxiing. This simple yet effective system has drastically reduced mistakes ending in death. Checklists and other redundant fail- safe interventions can be effective at drastically reducing iatrogenic morbidity and mortality in clinical settings (Gawande, 2007). Even so, the health care industry has been slow to fully implement these simple strategies (Gawande, 2007, 2009a).

Ben Birchall/Associated Press Implementing mandatory checklists can help reduce medical mistakes.

© 2019 Bridgepoint Education, Inc. All rights reserved. Not for resale or redistribution.

Section 6.2Legal and Administrative Strategies to Ensure Patient Safety

6.2 Legal and Administrative Strategies to Ensure Patient Safety

To reduce the risks of medical errors and ensure patient safety, the United States has adopted a complex patchwork of laws and administrative strategies. The most salient of these are outlined in this section.

State and Federal Regulation of Health Care Organizations Federal agencies such as the U.S. Food and Drug Administration (FDA) and the Office for Human Research Protections provide regulatory frameworks and oversight to help ensure the safety of patients, human subjects in research, and consumers in the United States. In the 1950s and 1960s, when thalidomide, an anti-nausea medication prescribed to pregnant women, was approved for use in the United Kingdom, Canada, and other countries, the FDA withheld approval in the United States after hearing reports of possible harms occurring in Europe (Potter, 1979). It soon became apparent that the drug caused horrific birth defects. Several thousand babies were born with limbs that were deformed or missing altogether. The FDA’s refusal was lauded as having spared many American babies from the same iatro- genic fate.

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

After two decades, professional review organizations were rebranded as quality improve- ment organizations. They still report to the Department of Health and Human Services’ Centers for Medicare and Medicaid Services and still operate largely as they did before the name change.

© 2019 Bridgepoint Education, Inc. All rights reserved. Not for resale or redistribution.

Section 6.2Legal and Administrative Strategies to Ensure Patient Safety

Many other federal agencies also affect health care organizations. For example, the Occupa- tional Safety and Health Administration (OSHA) is in charge of policing workplace safety. The U.S. Drug Enforcement Agency has jurisdiction over a long list of pharmaceuticals known as controlled substances. It licenses health care organizations and professionals to prescribe and handle these drugs safely. The Nuclear Regulatory Commission licenses and regulates the use of radioactive materials in health care. The Department of Homeland Security keeps close tabs on the radioactive materials that health care organizations use in order to protect health care providers, patients, and the public at large from the potential misuse or abuse of these volatile materials.

Regulatory frameworks such as these represent one of the ways the United States tackles the duty that health care professionals have to conform to the ethical principle of nonma- leficence. However, federal oversight through the work of regulatory requirements is not the only means of ensuring patient and consumer safety. There is also a complicated array of pro- fessional requirements, guidelines, and administrative strategies intended to reduce the risk of error and harm in health care. Several of these will be explored in the sections that follow.

Accreditation of Health Care Organizations According to the Medicare law, hospitals that voluntarily meet the accreditation require- ments of the Joint Commission (previously known as the Joint Commission on Accreditation of Health Care Organizations and before that as the Joint Commission on Accreditation of Hospitals) are deemed to comply with federal requirements and therefore are eligible for Medicare reimbursement. The Joint Commission publishes standards that hospitals (or other kinds of organizational health care providers) must meet, upon inspection, to earn accred- ited status. Although accreditation remains voluntary, most hospitals in the United States are accredited through the Joint Commission, both because they desire deemed status to receive Medicare payments and because of the perceived value of the public and professional cred- ibility that comes from being accredited.

The Joint Commission (2017) touts the following specific benefits of accreditation to health care organizations:

• Helps organize and strengthen patient safety efforts—Patient safety and quality of care issues are at the forefront of Joint Commission standards and initiatives.

• Strengthens community confidence in the quality and safety of care, treatment, and services—Achieving accreditation makes a strong statement to the community about an organization’s efforts to provide the highest quality services.

• Provides a competitive edge in the marketplace—Accreditation may provide a mar- keting advantage in a competitive health care environment and improve the ability to secure new business.

• Improves risk management and risk reduction—Joint Commission standards focus on state-of-the-art performance improvement strategies that help health care orga- nizations continuously improve the safety and quality of care, which can reduce the risk of error or low quality care.

• May reduce liability insurance costs—By enhancing risk management efforts, accreditation may improve access to and reduce the cost of liability insurance coverage.

© 2019 Bridgepoint Education, Inc. All rights reserved. Not for resale or redistribution.

Section 6.2Legal and Administrative Strategies to Ensure Patient Safety

• Provides education to improve business operations—Joint Commission Resources, the Joint Commission’s not-for-profit affiliate, provides continuing support and edu- cation to accredited organizations with services to help organizations in a variety of settings.

• Provides professional advice and counsel, enhancing staff education—Joint Commis- sion surveyors are experienced health care professionals trained to provide expert advice and education during the on-site survey.

• Provides a customized, intensive review—Joint Commission surveyors come from a variety of health care industries and are assigned to organizations that match their background. The standards are also specific to each accreditation program so each survey is relevant to your industry.

• Enhances staff recruitment and development—Joint Commission accreditation can attract qualified personnel who prefer to serve in an accredited organization. Accredited organizations also provide additional opportunities for staff to develop their skills and knowledge.

• Provides deeming authority for Medicare certification—Some accredited health care organizations qualify for Medicare and Medicaid certification without undergoing a separate government quality inspection, which eases the burdens of duplicative federal and state regulatory agency surveys.

• Is recognized by insurers and other third parties—In some markets, accreditation is becoming a prerequisite to be eligible for insurance reimbursement and to partici- pate in managed care plans or contract bidding.

• Provides a framework for organizational structure and management—Accreditation involves not only preparing for a survey, but maintaining a high level of quality and compliance with the latest standards. Joint Commission accreditation provides guid- ance to an organization’s quality improvement efforts.

• May fulfill regulatory requirements in select states—Laws may require certain health care providers to acquire accreditation for their organization. Those organi- zations already accredited by the Joint Commission may be compliant and need not undergo any additional surveys or inspections.

• Provides tools for accredited organizations—The Leading Practice Library offers good practices submitted by accredited organizations. The Targeted Solutions Tool, an interactive web-based tool from the Joint Commission Center for Transform- ing Health care, allows accredited organizations to measure their organization’s performance and help them find customized solutions for challenging health care problems.

• Aligns health care organizations with one of the most respected names in health care—Being accredited by the Joint Commission helps organizations position for the future of integrated care.

Source: © The Joint Commission, 2018. Reprinted with permission.

Among its other initiatives, the Joint Commission annually publishes national patient safety goals for various health care settings (http://www.jointcommission.org/standards _information/npsgs.aspx). Useful guidance on reducing errors by improving the quality of health care delivery is available from the Institute for Healthcare Improvement (http://www .ihi.org), although the institute has no regulatory authority.

© 2019 Bridgepoint Education, Inc. All rights reserved. Not for resale or redistribution.

Section 6.2Legal and Administrative Strategies to Ensure Patient Safety

There are other private bodies that, while not as prominent as the Joint Commission, also provide health care accreditation services. For example, the American Osteopathic Associa- tion (AOA) accredits osteopathic health care facilities. As with accreditation from the Joint Commission, an AOA-accredited health services organization is granted deemed status by the Centers for Medicare and Medicaid Services for purposes of reimbursement. Home health care and community health agencies can receive deemed status through their own accredita- tion program called CHAP, or Community Health Accreditation Program (2013), while many health plans and networks, such as those provided by large employers, are accredited by the National Committee for Quality Assurance (2013).

Accreditation of Educational Institutions Professional education programs in health care have several accrediting bodies that survey the programs to determine that minimal skills and competencies are being taught. Ever since an influential 1910 study by Abraham Flexner on the state of medical education in the United States, there has been a push for stricter standards (Duffy, 2011). The Flexner Report showed that American medical education originally consisted of dozens of colleges with widely dispa- rate approaches to teaching medicine and standards for judging academic performance, with virtually no consistency in the topics and materials covered in their curricula. Today medical schools receive oversight from and are accredited by the Liaison Committee on Medical Edu- cation, which is a partnership of the Asso- ciation of American Medical Colleges and the American Medical Association.

The quality of nursing within health care organizations is a key determinant of health care quality and patient safety. Nursing education is varied, with edu- cational programs accredited by the National League for Nursing.

Master’s-level education of health care administration is accredited by the Com- mission on Accreditation of Health Care Management Education, and graduate programs in public health are accredited by the Council on Education for Public Health.

Licensure, Registration, and Credentialing Attending and graduating from an accredited health care professional school or college does not, however, automatically entitle an individual to legally practice in the United States. In many cases, health care professionals and other allied workers must meet certain educational, training, and competency requirements before they are licensed to practice by the state. In

Burger/Phanie/SuperStock Medical schools face strict scrutiny in order to earn accreditation. This ensures that medical students are properly trained to the highest standard.

© 2019 Bridgepoint Education, Inc. All rights reserved. Not for resale or redistribution.

Section 6.2Legal and Administrative Strategies to Ensure Patient Safety

some cases, however, there are few requirements before working in health services organi- zations. For example, there are currently no federal or state minimum education or licen- sure requirements for hospital administrators, though all states require that nursing facility administrators be licensed (Longest & Darr, 2008). The purpose of the various accreditation processes is to ensure that educational institutions produce graduates who are qualified and competent to practice their respective professions.

Whether a health care professional is employed by an institution, such as a hospital or man- aged care organization, or works as an independent practitioner, that professional must, as noted, be licensed by the state. The particular licensing process depends on the specific profession.

After attending an accredited medical school, receiving either the degree of medical doctor (MD) or doctor of osteopathy (DO) and completing at least one year of residency at an accred- ited program, physicians are required to pass licensing examinations given by state boards before being able to legally practice in that state. Other professionals such as podiatrists, pharmacists, and nurses must undergo different requirements. Chiropractors, who tend to emphasize a different, more mechanical theory of health and wellness, must also undergo a series of licensing requirements before they are allowed to practice on the general public. Physicians educated outside the United States must pass additional rigorous examinations before being eligible for licensure.

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

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

© 2019 Bridgepoint Education, Inc. All rights reserved. Not for resale or redistribution.

Section 6.3Legal Liability of Health Care Organizations and Professionals

Professional Standards, Guidelines, and Other Policies Many organizations promulgate codes of conduct and professional standards to which their members should adhere in an effort to assure the public of the quality of their health care. For example, the American Nurses Association has established codes of nursing conduct as well as professional standards for member nurses (American Nurses Association, 2013). Guide- lines like these are important not only as public statements of minimal thresholds of quality, safety, and ethical care, but also because they help inform the thresholds for legal negligence and help in malpractice or professional liability contexts. Failure to comply with professional standards and guidelines for safe practice may stand as compelling evidence of a health care professional’s or health care organization’s breach of duty.

6.3 Legal Liability of Health Care Organizations and Professionals

Legal liability refers to the legal duties and responsibilities that are owed to another. Being liable for something means that adherence to a legal duty is required. It also implies that nonadherence to a legal responsibility exposes the person to a risk of successful adverse legal action. Legal liability is yet another method by which society attempts to ensure the qual- ity and safety of health care by compelling health care professionals to meet or sur- pass expected standards of practice and competence in their fields of expertise.

A Tort Law Primer In American jurisprudence, tort law con- cerns liability for breach of the legal duty to refrain from harming others. Tort law also provides disincentives for future risky or negligent conduct by awarding damages for conduct that falls below the standard of care. A tort refers to a wrong or harm toward another person that breaches society’s expectations for civil interpersonal conduct. For example, if a physician fails to pay close enough atten- tion and operates on the patient’s right arm when other, prudent physicians would have known to operate on the left arm, that physician has committed the tort of negligence. (Figure 6.2 shows the number of medical errors in the United States from 2004 to 2010.)

Cusp/SuperStock Legal liability is another method for ensuring high-quality health care by holding providers legally accountable for their performance.

© 2019 Bridgepoint Education, Inc. All rights reserved. Not for resale or redistribution.

Section 6.3Legal Liability of Health Care Organizations and Professionals

Figure 6.2: Patient outcome by type of “never” event, 2004–2010

The Institute of Medicine estimates that an average of 98,000 people die each year in the United States from some type of medical error. This chart provides a breakdown of the type of injury or death that resulted from physician errors.

Source: Reprinted by permission of GeoBeats Productions

Law in Focus: The Requirements of a Negligence Claim in Law

The law that governs when a medical professional makes a mistake requires that health care professionals be reasonably careful when treating patients. This reasonable expecta- tion is termed the standard of care, that is, the minimum conduct for which health care professionals are responsible. In medicine, things often go wrong, and bad results occur. This does not necessarily mean that there was negligence. As long as the health care prac- titioner was abiding by the standard of care, then a patient has not been legally wronged. Although the patient may have been unintentionally harmed in the process, he or she will not be successful in a court case for damages. If, on the other hand, the patient was harmed due to the failure of the health care professional to abide by the appropriate standard of care, then the patient has been wronged as well as harmed, and tort law can afford a legal remedy. Another name for care that unintentionally falls below the minimum requirements of the standard of care is negligence.

(continued on next page)

© 2019 Bridgepoint Education, Inc. All rights reserved. Not for resale or redistribution.

Section 6.3Legal Liability of Health Care Organizations and Professionals

Charitable Immunity Hospitals were initially charitable (either religiously affiliated or nonsectarian) institutions that were largely supported by donated monetary and human resources (Showalter, 2012). Today many hospitals and health care systems retain religious or other charitable connec- tions, but few people would confuse the charitable hospitals of today with the crude alms- houses of long ago. Nonetheless, for much of modern history, hospitals retained immunity from tort liability based on their charitable status. The policy rationale for charitable immu- nity was to keep these organizations performing their valuable function in society. It was also understood for many years that people who benefited from charity implicitly waived their rights to sue in return for free service (Showalter, 2012).

In the latter half of the 20th century, however, the change in public sentiment and societal circumstances under which health care organizations operated—even those that were not for profit—made the rationale for charitable immunity of health care organizations no longer compelling. Immunity also meant that there was no deterrent for negligent or reckless con- duct on the part of health care workers or institutions. Although some government or public hospitals in a few jurisdictions continue to enjoy a narrower type of immunity from liability based on the doctrine of sovereign immunity, the injustice of wrongfully harmed but uncom- pensated patients eventually pushed every state to dissolve or limit charitable immunity for health care organizations.

Law in Focus: The Requirements of a Negligence Claim in Law (continued)

For a civil lawsuit based on a claim of negligence, the plaintiff has the burden to prove all four of the following:

1. The health care professional must have a legal duty to uphold the standard of care for this particular patient. This duty means that a legal relationship exists. This usu- ally occurs whenever a patient presents for health care and the health care institu- tion or professional admits the patient. A doctor–patient relationship may be ongo- ing (primary care), time bound (emergency care), or issue bound (specialty care). Even if the harm does not occur until after the provider–patient relationship ends, if it can be shown to be the direct consequence of the care received, courts will hold that since the duty existed at the time of treatment, the duty requirement is fulfilled for purposes of a negligence claim.

2. The plaintiff must show that the health care professional failed to uphold the mini- mum standard of care relevant to the case. For instance, failure to ask the patient about known drug allergies prior to prescribing a new medication could constitute a breach of legal duty.

3. The plaintiff must show that they were harmed. 4. The plaintiff must also show that the harm was proximately or directly caused by

the breach of legal duty.

© 2019 Bridgepoint Education, Inc. All rights reserved. Not for resale or redistribution.

Section 6.3Legal Liability of Health Care Organizations and Professionals

Corporate Liability Hospitals and other health care organizations are legally liable for failing to exercise the rea- sonable duty of care and concern for the rights, welfare, and safety of their patients. Through the legal doctrine of corporate liability, health care organizations can be found negligent in carrying out their responsibilities. For many years hospitals were seen as workshops in which independent health care physicians practiced. It was beneficial to hospitals to cultivate this fiction, since it had proved successful in relieving hospitals from liability, as we will see below. Today, hospitals and their administrators do not see their role as simply furnishing the physical accommodations for professionals to do independent work—and neither should the courts. An entity that presents itself as a health care organization that provides the com- munity with health care services has ethical and legal duties to provide those services and facilities safely and not negligently.

The rationale for the corporate liability doctrine is exemplified in the 1957 landmark case of Bing v. Thunig, in which the court found:

The conception that the hospital does not undertake to treat the patient, does not undertake to act through its doctors and nurses, but undertakes instead simply to procure them to act upon their own responsibility no longer reflects the fact. Present-day hospitals, as their matter of operation plainly demonstrates, do far more than furnish facilities for treatment. They regularly employ on a salary basis a large staff of physicians, nurses and interns, as well as administrative and manual workers, and they charge patients for medical care and treatment, collecting for such services, if necessary, by legal action. Certainly, the person who avails himself of “hospital facilities” expects that the hospital will attempt to cure him, not that its nurses or other employees will act on their own responsibility.

The doctrine of corporate liability is therefore used to find health care organizations liable whenever they recklessly or negligently fail to uphold minimum standards of care, such as not having the appropriate supplies, equipment, or personnel to properly staff a division or department. To illustrate further, if background checks are the standard of care, a long-term- care facility that fails to do a background check when hiring a health care worker with a his- tory of violent crime who subsequently assaults and injures a patient is liable for such an oversight.

Vicarious Liability Vicarious liability is the principle that an organization is ultimately liable for the negligent acts and omissions of its employees or supervisees. Under vicarious liability, an employer or superior is liable regardless of whether he or she was personally or directly at fault. Vicarious liability is based on the principle that organizations or principals ought to be held responsible for the acts of employees or supervisees who are acting within the scope of their employment. The expectation is that when an organization finds itself exposed to liability for the conduct of its employees, it will more carefully train employees to ensure patient safety.

As an ethical precept and as public policy, the principle of vicarious liability is a defensible legal doctrine. The negligent behavior of one health care worker can cause great harm. If the negligent party were personally forced to pay, then that one person might be financially

© 2019 Bridgepoint Education, Inc. All rights reserved. Not for resale or redistribution.

Section 6.3Legal Liability of Health Care Organizations and Professionals

ruined (which may be an excessive punishment), and the resultant recompense for the injured party may be insufficient. Employers and health care organizations have the financial means to adequately cover their claims through insurance and are better equipped to compensate those who may have been harmed by their supervised employees.

Not everyone working within the physical confines of a health care institution is an employee of that institution. Physicians in particular are independent practitioners who contract with the organization. Since vicarious liability rests on the requirement of an employment or supervisory relationship, independent contractors who have control over their own work are generally held solely responsible for their own actions.

This is one of the main reasons that most hospitals historically have related to physicians as independent contractors through the process of privileging. Under these circumstances, vicarious liability could not be applied, which resulted in lowered risk for hospitals because they could not be found vicariously liable for the negligence of independent contractors. Without an employment relationship, hospitals could effectively wash their hands of doctors’ negligent conduct, even if the institution knew of such conduct.

Since these risk-lowering arrangements tend to thwart the objectives of the tort system (com- pensating injured victims and deterring undesired conduct), courts have grown increasingly impatient with the avoidance of responsibility on the part of some health care institutions. Today, courts are more willing to discover employment-like relationships even where only independent contractor language exists. Moreover, more physicians and other health care professionals who were formerly kept at arm’s length as independent contractors are now likely to have employment contracts with the institutions where they work.

Even institutions that continue to operate through independent contractors, however, may be held vicariously liable for their actions. This is because, in an increasing number of cases, plaintiffs can show that they reasonably believed that the health care professional was acting as an agent or employee of the health care institution and relied on that belief in seeking care. This is known as apparent agency and may make the health care organization liable despite the fact that the health care worker whose negligence was the proximate cause of the harm was seen by the organization to be an independent contractor.

Tort Reform The use of tort law to ensure the quality and safety of health care is a divisive public policy issue. Although there is general agreement that tort law can be an effective means to ensure compliance with minimal standards, many question whether it creates effective deterrence to bad behavior and at what point it starts to become an impediment to effective health care.

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

© 2019 Bridgepoint Education, Inc. All rights reserved. Not for resale or redistribution.

Section 6.3Legal Liability of Health Care Organizations and Professionals

cover her medical expenses and compensatory damages, with the remaining $2.7 million as punitive damages against McDonald’s. The case was an overnight media sensation; late-night talk show hosts parodied the frivolity of the case and the astronomical damages awarded by the jury (Cain, 2007). It became a flashpoint in the already contentious debate over tort reform in the United States. Politicians cited the case as an example of a justice system gone awry, in which the fear of crippling financial loss might quell commercial, industrial, and pro- fessional progress and ambition. The McDonald’s coffee case became the impetus for pass- ing tort law changes in some states. Changes in tort law impact health care as well as other sectors.

The Hot Coffee Case A closer look at the Liebeck case reveals a less egregious, and perhaps even a just, result (Cain, 2007; Greenlee, 1997; Gerlin, 1994). On a winter morning in 1992, 79-year-old Stella Liebeck, while in the passenger seat of a parked car, attempted to remove the lid from her 49-cent cup of McDonald’s coffee to add cream and sugar. She placed the cup between her knees, and while she tried to remove the lid, the entire cup of coffee spilled directly into her lap. The burns were so intense that her grandson, who had been driving the car, rushed her to the emergency room of a local hospital, where she was diagnosed with third-degree burns to her thighs, groin, and buttocks—some of which destroyed her tissues to the bone. She also received less severe burns and scalds over a greater portion of her body. Liebeck had to undergo acute medical treatment, including skin grafts, as well as two years of subsequent medical treatment for the burns, from which she continued to suffer (Cain, 2007).

Following the incident, her family approached McDonald’s Restaurants to alert them that the coffee was much too hot. They later asked McDonald’s for $20,000—enough to cover her past and future medical expenses related to the incident, as well as her loss of income. Instead, the mega-corporation offered her $800 to settle any claim. After retaining counsel, Liebeck sued McDonald’s.

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

The answer to this question remains a matter of interpretation, but internal corporate docu- ments corroborated what some policy makers, economists, and organizational psychologists fear is a corporate temptation in these types of situations. Enjoying the sizable profits that come from having an in-demand product, a business will be very reluctant to change the product in any way that may affect its profitability. Many commuters, for example, may not drink their coffee until several minutes after the initial purchase, and it stands to reason that

© 2019 Bridgepoint Education, Inc. All rights reserved. Not for resale or redistribution.

Section 6.3Legal Liability of Health Care Organizations and Professionals

the hotter the initial temperature, the “fresher” the coffee will be when finally consumed. Tort law is designed to overcome this economic reluctance (which can translate into unethical and even illegal behavior) by making the repercussions too great (both in expense and in loss of public trust) for the company that refuses to make its products safe.

However, this means that the financial disincentives provided by tort law must actually effec- tively deter the bad behavior. This was not the case with McDonald’s. Despite hundreds of past coffee burn allegations, some of which had resulted in settlements or judgments of more than $500,000 (Gerlin, 1994), the McDonald’s quality control manager testified that the num- ber of injuries and costs to settle these cases out of court were insufficient to cause the com- pany to seriously reevaluate its practices (Nader & Smith, 1996). When economic damages are insufficient to cause businesses to change potentially bad behavior, the threat of tort suits are ineffective. Therefore, it is essential that damages be substantial enough to serve as a disincentive to the potentially negligent party. For a company as large as McDonald’s, which at that time made more than $1 million every day in profit on coffee sales alone, financial damages must be large enough for the company to take notice. The jury felt that the punitive damages were not excessive and might be enough to get the attention of McDonald’s (though economists and business psychologists might argue that this sum, amounting to no more than two days’ worth of McDonald’s coffee sales, might still be too low to be a real disincentive). The media and public outcry was immediate and vehement, however, and pressured the trial court to reduce the punitive award to $480,000, although the judge characterized McDonald’s conduct as reckless, callous, and willful.

Return to Tort Reform It is important to distinguish the McDonald’s case, for which a plausible argument might be made in favor of awarding punitive damages in addition to compensatory damages, from the typical medical malpractice lawsuit. In the latter, ordinarily there is no viable claim of reck- less or willful misconduct; instead, almost all professional malpractice cases are predicated on the theory of negligence, or unintentional deviation from the standard of care owed to the patient. Thus, the awarding of punitive damages (which are intended to punish the wrong- doer for intentional or reckless and wanton conduct) is exceedingly rare in the malpractice context.

Nonetheless, the fallout from the McDonald’s case has implications for health care delivery. Some states have amended their tort laws to make it more difficult to recover damages, as well as placed caps on the total amount of damages possible. Some states made it difficult for patients who had been harmed to be successful in a lawsuit and reduced the chances of being awarded damages that might be sufficient to change bad habits, not to mention enough to cover medical expenses, lost wages, and reduced quality of life.

Despite the tort reforms that various states have undergone since the 1980s, medical malprac- tice insurance premiums continue to be a significant expenditure by health care practitioners. Expenses related to defensive medicine and risk management by health care organizations continue to escalate. Because of this, health care organizations spend inordinate amounts of time, resources, and money to reduce their risk profile and will often automatically pre- sume an adversarial stance whenever an error, or even a bad outcome, occurs (Elliott, 2010). (Figure 6.3 shows the rising costs of medical malpractice in the United States.)

© 2019 Bridgepoint Education, Inc. All rights reserved. Not for resale or redistribution.

Section 6.3Legal Liability of Health Care Organizations and Professionals

Figure 6.3: Medical malpractice costs, 1975–2009

Order now and get 10% discount on all orders above $50 now!!The professional are ready and willing handle your assignment.

ORDER NOW »»