Introduction
Patient safety is defined as freedom from accidental medical injury. Identifying such “adverse medical events” as a source of human suffering, the World Health Organization in 2002 recognized that the need to improve patient safety was a fundamental principle of all health systems. The concept of patient safety offers a positive spin on the more emotionally laden concept of medical error. Traditionally regarded as the result of incompetent or poorly prepared or motivated clinicians, medical error is now understood as a product of poorly designed systems of care that contribute to harm. The modern view of medical error is that patient safety can be produced only in organizations that take a systems-based approach to the problem, recognizing the inherent limits of human performance and the need to engineer the care delivery process in a way that is based on scientific principles. Nowhere is this issue more pressing than in the acute care hospital.
Patient safety emerged as a public health problem following the November 1999 release of To Err Is Human by the Institute of Medicine (IOM). This report described the epidemic of medical errors in the United States, accounting for as many as 98,000 unnecessary deaths per year. The IOM report described an approach to understanding this problem that relied on developments in human factors engineering and cognitive psychology. By focusing on methods to diagnose and improve systems of care, the report pointed to a novel approach for addressing this epidemic.
The IOM report provoked a broad response. The President of the United States directed the federal health care agencies to review and implement the recommendations outlined in the report. The agency responsible for research on quality of care issued $50 million in research grants. Accreditation agencies such as The Joint Commission developed standards and goals related to patient safety that would be required of hospitals. A group of Fortune 500 companies organized themselves into a consortium called the Leapfrog Group in order to encourage these organizations to purchase health care for their employees from organizations that met high standards for patient safety, including the use of intensivist physicians and electronic order entry systems. Advocacy groups such as the Institute for Healthcare Improvement created campaigns and collaborative partnerships to spread patient safety–related improvements. And local, regional, and state organizations banded together to cooperate on initiatives to reduce medical errors. In short, the To Err Is Human report helped to crystallize a movement in the United States (and abroad) that brought a new intensity of purpose to enhancing patient safety and reducing medical errors.
Much of the early work on patient safety focused on hospitalized patients. This occurred for several reasons. Inpatients were judged to be particularly vulnerable by virtue of their acute illness, comorbidities, and the intensity of the interventions delivered. Hospitalized patients were more accessible to investigators for study. And improvements that affected the system of care were more readily developed and deployed in the hospital compared to settings such as ambulatory care, with fewer centralized resources to support measurement and improvement initiatives.
Given the central place of the acute care hospital in efforts to study and improve patient safety, hospitalist physicians are particularly well positioned to serve as patient safety champions in their organizations. Hospitalists are close to the delivery of care, so that they are knowledgeable about how errors and injuries occur. They understand how current systems may contribute to harm. And they are likely to have an informed perspective about the kinds of improvements that are likely to be both feasible and effective. Physician involvement is a critical component of successful improvement projects, and hospitalists are well equipped to participate in a meaningful way.
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Scope of the Problem
Medical error was long regarded as a rare phenomenon. In the 1980s and 1990s, however, sentinel cases brought widespread attention to this problem. Among the most widely publicized cases was that of Libby Zion, a young woman who died at New York Hospital in 1984 after she was prescribed meperidine and a monoamine oxidase inhibitor—a fatal combination. Ten years later, Betsy Lehman, a young mother and Boston Globe reporter, died of an accidental chemotherapy overdose due to an ambiguous medication order.
A series of subsequent studies found that errors were common, especially among patients admitted to the hospital through the emergency department. The first large, epidemiologic study of medical errors was reported in the 1991 New England Journal of Medicine.4 The Harvard Medical Practice study examined over 30,000 medical records of patients hospitalized in New York State in 1984. Investigators learned that 3.7% of patients had an “adverse event” defined as an injury due to medical care. These patients had serious adverse events, including those that extended the patient’s hospitalization, or resulted in death or disability. These medical injuries resulted from surgical and medical care at similar rates, though the events that occurred on the medical service were more often judged to be preventable. Indeed, about one in four events was found to be the result of negligence: care that fell below community standards of medical care.
The Medical Practice Study was an affront to the concept that medical injuries are rare events. Although critics challenged the results, the findings have proven robust. Replications of the Medical Practice Study in Colorado and Utah (in the United States), Canada, United Kingdom, Australia, Spain, and France all show substantially similar results. Five to 10% of hospitalized patients experience an adverse event due to medical care during their hospitalizations, and many are preventable. Researchers extrapolated the Colorado and Utah study results to calculate the 44,000–98,000 excess deaths reported in the IOM’s To Err Is Human report.
Although all hospitalized patients are at risk of medical errors, certain groups seem to be at particular increased risk. The youngest young and the oldest old are particularly vulnerable, perhaps due their reduced physiological reserve.6 An error affecting a sick, elderly person may be more likely to result in injury than in a younger person with fewer comorbidities. The same is true for young children. The need to calculate weight-based medication doses confers on children an increased risk due to medication errors.
Other patients at high risk include those undergoing neuro-, thoracic, or vascular surgery. These are inherently risky procedures and often performed on individuals with multiple or serious underlying comorbidities. Patients admitted urgently are at higher risk than elective admissions. In addition, the number of interventions a patient experiences increases the opportunities for a mishap. In the Adverse Drug Event Prevention study, Bates and colleagues reported that the highest rates of adverse drug events were among patients in the medical intensive care unit. This was due to the greater number of medications and doses these patients received.
Medication-related errors and adverse drug events are an area of special interest to researchers and practitioners, since these events account for the greatest proportion of adverse events among admissions to the medical service. Studies that examined adverse drug events among hospitalized patients identified a consistent list of medications that account for a disproportionate share of serious incidents: anticoagulants, antibiotics, chemotherapy agents, narcotics and sedatives, and insulin.
Adverse drug events have been a particularly fruitful area of work in patient safety, resulting in the dissemination of improvements in electronic order-entry systems, pharmacy safe practices, and guidelines for use of high-alert medications. Researchers are now beginning to tackle the problem of diagnostic error. This interest is driven in part by the prominence of missed and delayed cancer and myocardial infarction diagnoses among malpractice claims. Research has focused on the development of methods to understand lapses in critical processes of care, such as communicating and interpreting critical test results, and ensuring timely completion of referrals. Other thought leaders have focused attention on how doctors think. Can we train clinicians to avoid premature closure of diagnostic options by maintaining a broad differential diagnosis? How can we help them to avoid common mistakes, such as confirmation bias or premature conclusions?
Another emerging area of particular interest to Hospital Medicine physicians involves the risks associated with handoffs and transitions of care. Hospital Medicine practice is rife with opportunities to transition patient care to other hospitalists at the end of the shift or the week, to coordinate care with subspecialists and with colleagues in nursing and pharmacy, and to interact with the referring community practitioner. Research shows that hospital discharge is a particularly vulnerable time for patients, and a time when errors may occur for a variety of reasons. Failure to reconcile medications at discharge may lead to confusion on the part of patients. Handoffs to community physicians may fail to occur if the hospital discharge summary is delayed or incomplete. Recommended tests and procedures following discharge are often missed. Promising approaches to address these problems include standardization of handoffs through the use of templated sign-out forms, electronic communication with referring providers, and hospitalist-staffed postdischarge follow-up clinics.
Creating effective interventions relies on a solid understanding of the nature of error in health care, the methods to assess risk in health care organizations, and the tools that are used to develop patient safety improvements. These topics are the focus of the remainder of this chapter.
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