Media reports of health care errors are hardly new, although in recent years high-profile cases-like that of Betsy Lehman, whose death resulted from a chemotherapy overdose at Boston's Dana-Farber Cancer Institute in 1994-have received heightened media scrutiny. All nurses are familiar with stories of incorrectly administered medications or dosages, amputation of the wrong limbs, and misdiagnoses resulting in lack of treatment. Yet, last November, the news that health care errors cause up to 98,000 deaths among hospitalized patients each year made national headlines.1
What caused this surge of interest? An expert panel at the Institute of Medicine (IOM), a division of the National Academy of Sciences, had just released its first report, To Err Is Human: Building a Safer Health System.1 The report demonstrated that health care error is more than a series of isolated incidents; it is endemic to the U.S. health care system. The IOM panel examined two studies of adverse events among large samples of hospitalized patients2, 3 and estimated that health care error may have accounted for close to 100,000 deaths of hospitalized patients in 1997. This figure pertains only to deaths-not to serious injuries-of inpatients.
A SYSTEMS PROBLEM
A small but growing cadre of researchers and analysts had already begun to identify health care error as a widespread systems problem.4 Even before the IOM report was published, the findings and perspectives of these researchers and analysts had started to influence policy makers. In its final report, for instance, President Clinton's Advisory Commission on Consumer Protection and Quality in the Health Care Industry devoted a chapter to patient safety and health care error.5
Typically, when a health care error has occurred, efforts have focused on identifying those responsible and taking action against them-which may include remedial training, suspension or firing, disciplinary action by a state licensing board (such as censure or suspension or loss of license), malpractice suits, and even (rarely) criminal prosecution.
Over the last decade, many of these experts have proposed a different approach, one that the IOM report has largely endorsed. They've argued that handling errors after they occur by focusing solely on the clinicians involved fails to identify or correct systems problems that cause or contribute to error. Anyone, even the most conscientious professional, can make a mistake; removing all of these individuals from patient care won't prevent further errors. Moreover, it's been argued, the "culture of blame"-in which the people associated with an error are singled out, censured, and punished-only discourages the reporting of errors. Many (including the IOM panel) advocate creating a "culture of safety" that would reduce the stigma imposed on those associated with errors, create incentives for those reporting errors, and identify and correct the contributing systems problems.
Systems problems include illegible orders, medications bearing similar names or packaging, potentially dangerous drugs kept in hospital floor stock, inadequate double checks for certain surgical procedures, and the notoriously long work hours required of medical residents. Nurses have voiced similar concerns about an increased potential for error associated with overtime shifts and, more generally, short staffing and increased patient loads.6
Current hospital incident reporting systems are widely considered unreliable in measuring and describing the true extent of health care error.7, 8 It's generally believed that practitioners underreport their errors, most likely because they fear the consequences.
Advocates of a systems approach to understanding health care error refer approvingly to the Aviation Safety Reporting System, a "blame-free" program used in the aviation industry since 1975. Reports of safety problems and violations are "de-identified" and analyzed to provide a basis for safety improvements, thus enhancing aviation safety.9 Although many aspects of the Aviation Safety Reporting System model would be hard to apply to the health care industry, it's generally seen as a model to emulate.
MANDATORY REPORTING
One of the IOM report's more controversial proposals would mandate that hospitals report any adverse events that result in patient death or serious harm to state agencies. Currently, about one-third of states require some form of reporting, but there's little consistency regarding the type of incident that requires reporting and the way in which it should be done. State agencies often collect information as aggregate data, making comparisons between hospitals impossible. The IOM report also encourages continued development of voluntary reporting systems (there are many kinds-for example, by hospitals to states; by an industry to consumers).
While the American Medical Association and the American Hospital Association reacted cautiously to proposals for mandatory reporting of errors, the American Nurses Association (ANA) gave its strong support to the proposal. The ANA has also urged that data be collected and reported that might show a link between the occurrence of error and organizational characteristics-such as staffing levels, staff mix, and use of overtime.10
It's possible that public disclosure of error rates could lead hospitals to underreport. And hospitals that do report errors diligently could appear-perhaps unfairly-to be less safe than other facilities. An effective system of mandatory reporting and disclosure must include clear means of enforcement as well as protection for employees who report errors.
SOME INITIATIVES MAY NOT REQUIRE PRECISE DATA
Mandatory reporting could be the first step toward improving our understanding of health care error. But much can be done with information that's already available. For instance, precise figures for errors associated with illegible medical orders aren't necessary to conclude that lives could be saved by instituting computerized ordering systems. And there have been enough errors involving IV administration of undiluted potassium chloride to convince patient safety experts that this form of the drug should be removed from hospital floor stock.
Concerns about the effects of exhaustion on judgment and performance have led to efforts to limit medical residents' hours and have come up in criticisms of mandatory nurse overtime.
FEDERAL ACTION
After the IOM report appeared, President Clinton instructed an interagency federal panel to report on initiatives to reduce health care error. The Quality Interagency Coordination Task Force, in its February 2000 report, has proposed a series of recommendations to this end.11 The president also recently announced initiatives that are intended to improve patient safety protocols at federal hospitals, create a center for quality improvement and patient safety, develop regulations requiring all hospitals that receive Medicare to implement error-reduction programs, and develop new standards for pharmaceutical safety.12
The IOM report has plainly propelled the debate on patient safety and health care error. It has raised public awareness of the issue and put patient safety as an indicator of health care quality on the policy map. We'll need the broadest efforts of nursing organizations, direct care nurses, nurse administrators, and nurse researchers-including efforts to identify and implement best practices for error reduction, and recommendation and support of sound policy proposals-to ensure that patients continue to be protected from error.
Accountability
As the focus shifts from how individuals bear responsibility for errors toward systems accountability, some critical questions arise13:
* How should accountability be apportioned between individuals and systems?
* Does the fear of facing personal consequences make practitioners more careful?
* What is the quickest, most effective way to induce hospitals to adopt practices that may prevent or reduce error incidence?
* As the burden of accountability shifts, will nursing and other health care professions lose a degree of autonomy in determining appropriate standards of practice for their members?
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