Accountability: Patient Safety and Policy Reform

Introduction: Accountability and Justice in Patient Safety Reform

I N T R O D U C T I O N Accountability and Justice in Patient Safety Reform V I R G I N I A A . S H A R P E Introduction and Background The Institute of Medicine (IOM) report To Err Is Human presented the most comprehensive set of public policy recommendations on medical error and patient safety ever to have been proposed in the United States. Prompted by three large insurance industry–sponsored studies on the frequency and severity of preventable adverse events, as well as by a host of media reports on harmful medical errors, the report offered an array of proposals to address at the policy level what is being identified as a new “vital statistic”: that as many as 98,000 Americans die each year as a result of medical errors—a figure higher than deaths due to motor vehicle accidents, breast cancer, or AIDS. And this figure does not include those medical harms that are serious but nonfatal. The IOM recommendations resulted in a surge of media attention to the issue of medical error and in swift bipartisan action by President Clinton and the 106th and then the 107th Congress. Shortly after the report was issued in 2000, President Clinton lent his full support to efforts aimed at reducing medical error by 50 percent over five years. In Congress, the report prompted hearings and the introduction of a host of bills including the SAFE (Stop All Frequent Errors) Act of 2000 (S. 2378), the Medication Errors Reduction Act of 2001 (S. 824 and H.R. 3292), and recently the Patient Safety and Quality Improvement Act of 2002 (S. 2590) and the Patient Safety Improvement Act of 2002 (H.R. 4889). Although none of these bills has made it into law, each represents ongoing debate about the recommendations in the IOM report. Because the IOM recommendations have been either a catalyst or a touchstone for all subsequent patient safety reform proposals—whether by regulation or by institutions hoping to escape regulatory mandates—I introduce this volume with a brief description of the IOM report’s point of departure, the problem it seeks to address, and the solutions it identifies. From there, this chapter maps out the 1 Intro pp 1-26 08/05/2004 16:31 Page 1 ethical values and issues that subsequent chapters address as a basis for policy deliberation. The Institute of Medicine Report The Institute of Medicine report is a public policy document. That is, it proposes the need for government intervention to address a problem of serious concern to public health and health care financing. Although there was an immediate flurry of resistance to the report’s statistics on the number of deaths associated with preventable medical error—a key premise in the argument establishing the scope and significance of the problem—these challenges have been effectively silenced by the preponderance of evidence that the rate of harmful medical error—with its enormous human and financial consequences in death, disability, lost income, lost household production, and health care costs—is unacceptable. The report observes that health care has lagged behind other industries in safety and error prevention, in part because, unlike aviation or occupational safety, medicine has no designated agency to set and communicate priorities or to reward performance for safety. As a result, the IOM’s keystone recommendation is the establishment of a center for patient safety to be housed at the Agency for Health Care Quality and Research under the auspices of the Department of Health and Human Services. The center’s charge: to set and oversee national goals for patient safety. In order to track national and institutional performance, and to hold institutions accountable for harm, the IOM also proposes mandatory , public, standardized reporting of serious adverse events. In addition to mandatory reporting, the IOM advocates efforts to encourage voluntary reporting. To motivate participation in a voluntary reporting system, the IOM recommends legislation to extend peer review protections, that is, confidentiality , to data collected in health care quality improvement and safety efforts. To complement the national initiative, the IOM recommends that patient safety be included as a performance measure for individual and institutional health care providers and that institutions and professional societies commit themselves to sustained, formal attention to continuous improvement on patient safety. Finally, regarding medication safety, the IOM recommends increased attention by the Food and Drug Administration (FDA) and by health care organizations to identify and address latent errors in the production...