Should any of the individuals in the OR have been charged with a  crime, such as negligence or involuntary manslaughter? If s

6Medical Mistakes and Patient Safety

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Learning Objectives

After reading this chapter, you should be able to

1. Explain reasons for the prevalence of medical mistakes.

2. Describe mistakes that threaten patient safety.

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

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

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

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

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

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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.

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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.

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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.

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