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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.

Defining the Problem

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.

Hospitalized Patients

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 ...

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