In the 108th Congress, the House and Senate passed competing versions of the Patient Safetyand Quality Improvement Act ( H.R. 663 , S. 720 ). Despite broad bipartisansupport for the legislation, no further action took place before adjournment in December 2004. OnMarch 9, 2005, the Senate Committee on Health, Education, Labor, and Pensions (HELP)unanimously approved a new patient safety bill ( S. 544 ), which is identical to last year'sSenate-passed measure. The patient safety legislation is intended to encourage the voluntaryreporting of information on medical errors by establishing federal evidentiary privilege andconfidentiality protections for such information. Health care providers are reluctant to reportmedical errors because they fear that the information will damage their reputations and be used inmedical malpractice lawsuits. Patient safety emerged as a major health policy issue in late 1999 with the release of theInstitute of Medicine's (IOM) report To Err Is Human. (1) The IOM report concluded that preventable medical errors causeas many as 98,000 deaths each year and called on all parties to make improving patient safety anational health policy priority. It recommended establishing a national mandatory reporting systemto hold hospitals and other health care facilities accountable for errors that lead to serious injury ordeath. Emphasizing that medical errors are primarily the result of faulty systems, process, andconditions that lead people to make mistakes, the IOM also recommended the development ofvoluntary, confidential systems for reporting medical errors that result in no harm (i.e., close calls)or minimal harm. Analysis of such voluntarily reported information could then be used to identifysystem vulnerabilities and develop preventive strategies. The Patient Safety and QualityImprovement Act attempted to implement that recommendation. The IOM based its conclusions on epidemiologic studies published in the 1980s and early1990s. While medical researchers were familiar with the published estimates of the prevalence ofmedical errors in hospitals and other inpatient settings, the information was new to the public andit caught the attention of federal and state legislators and health care policymakers. Indeed, a 1999survey showed that patient safety was the most closely followed health policy story of the year. (2) As a result of the IOM report,numerous patient safety initiatives were initiated within the federal government and throughout theprivate sector, in health plans and health care trade organizations and accrediting andstandard-setting bodies. States responded to the IOM report by considering legislation to expand existing mandatoryreporting systems and, in some cases, enact new systems. Currently, 22 states have mandatoryreporting systems. The goal is to hold hospitals and health care providers accountable to the publicfor the most serious mistakes in the delivery of health care. In an effort to encourage providers toreport errors, most states have adopted measures to protect reporting system data from use bymalpractice attorneys. Policymakers have had to balance provider concerns about the legalconsequences of making information available to attorneys and patients with the desire for publicaccountability. Legislation to encourage medical errors reporting was first introduced in the 106th Congress,following the release of the IOM report. (3) Much of it was reintroduced in the 107th Congress and again in the108th. Patient safety lies at the heart of the current debate on medical malpractice reform. Many trialattorneys defend the current tort system, claiming that the threat of litigation makes providerspractice safer medicine. They view tort law as an important driver of health care quality. Butexperts on health care quality reject this argument. Echoing the IOM's recommendations, theycontend that the only way to realize significant improvements in patient safety is by improving healthcare systems. And that, in turn, requires the analysis of medical errors report. By discouragingphysicians from reporting such information, the tort system is in conflict with this approach to safetyimprovement. This report provides an overview and some analysis of medical errors reporting and theHouse and Senate patient safety bills. It begins with background information on the nature andcauses of medical errors, followed by a brief comparison of the differences between mandatory andvoluntary reporting systems. The report then discusses some of the legal and policy issues facingstate mandatory reporting systems and major national voluntary reporting systems, and identifiesdesign features of effective reporting programs. It concludes with a discussion and side-by-sidecomparison of H.R. 663 and S. 544 . The IOM report defined error as the failure of a planned action to be completed as intended(an error of execution) or the use of a wrong plan to achieve an aim (an error of planning). Medicalerrors can happen at all stages of the process of care, from diagnosis, to treatment, to preventive care. Not all errors result in harm. Those that do are referred to as preventable adverse events. An adverseevent is an injury related to a medical intervention and not due to the underlying medical conditionof the patient. While adverse events are often attributable to error and, therefore, preventable, theyneed not always be the result of medical mismanagement (see discussion of adverse drug reactionsbelow). A limited number of published studies have examined adverse events among hospitalizedpatients. Extrapolating from the results of two large, retrospective reviews of hospital records, theIOM estimated that more than 1 million medical errors occur each year in the United States, of whichbetween 44,000 and 98,000 are fatal. (4) It also concluded that errors may cost the nation as much as $29billion annually in direct medical costs and lost income and productivity. Some researchers havechallenged the accuracy of the IOM's numbers, but there is general agreement that the problem isserious. (5) Still others saythe IOM may have underestimated the true incidence of medical errors because it only considerederrors that occur among hospital patients, which represent a small proportion of the total populationat risk. Many patients receive increasingly complex care in ambulatory settings such as outpatientsurgical centers, physicians' offices, and clinics. Echoing the views of most health care analysts, the IOM emphasized that medical errors areprimarily a systemic problem and generally not attributable to individual negligence or misconduct. Errors are the result of faulty systems, processes, and conditions that lead people to make mistakes. According to the IOM, health care lags behind other industries (e.g., aviation, nuclear power) thatpay attention to factors that affect performance, such as work hours, work conditions, informationtechnology, team relationships, and the design of tasks to make errors more difficult to commit. While there have been few studies that examined all types of adverse events occurring inhospitals and other provider settings, there is an abundant literature that focuses on adverse drugevents (i.e., adverse events specifically associated with ordering and administering medication topatients). Adverse drug events are often found to be the most common type of adverse eventdocumented in hospital settings. In its report, the IOM estimated that drug-related adverse eventskill up to 7,000 Americans annually. Although the distinction is not always clear, researchers divide adverse drug events into twotypes: adverse drug reactions resulting from previously known or newly detected side effects ofdrugs that are correctly prescribed and administered; and injuries that are caused by errors inprescribing, dispensing, and administering medication. Examples of medication errors includephysicians who prescribe antibiotics to patients with documented allergies to those medications,nurses who do not properly dilute intravenous solutions, and patients who fail to take medicationsas directed. Studies reveal that adverse drug events occur in 6.5% to more than 20% of hospitalizedpatients, and that between one-quarter and one-half of these are due to medication errors and are,therefore, avoidable. (6) Newly published research on medication safety among Medicare patients in outpatient settingssuggests that the Medicare population as a whole may experience as many as 180,000life-threatening or fatal adverse drug events annually. (7) It is important to recognize that the majority of medication errorsdo not lead to an adverse drug event, either because they are caught before the drugs areadministered, or because they result in no ill effects. In the IOM's analysis, medication errorstypically result from one or more failures in the increasingly complex systems of medicationmanagement, rather than from negligence on the part of individual health care practitioners. The IOM recommended establishing a nationwide mandatory reporting system for statesto collect standardized information (initially from hospitals, but eventually from other institutionaland ambulatory health care settings) on adverse events that result in death or serious harm. Theprimary purpose of mandatory reporting systems is to hold providers accountable by ensuring thatserious mistakes are reported and investigated and that appropriate follow-up action is taken.Organizations that continue unsafe practices risk citations, penalties, sanctions, suspension orrevocation of licenses, and possible public exposure and loss of business. The IOM proposed thatmandatory reporting system data be made available to the public once they have been validated. To complement the mandatory reporting of serious and fatal errors, the IOM alsorecommended the development of voluntary reporting systems for collecting information on errorsthat result in little or no harm. The focus of voluntary reporting is the analysis and identification ofsystemic problems that could lead to more serious types of errors, and the development of preventionstrategies. To encourage reporting, the IOM further recommended that information collected undera voluntary reporting system be strictly confidential and protected from legal discovery. Table 1 summarizes the differences between mandatory and voluntary reporting systems. State adverse event reporting systems date back to the 1970s. The IOM reviewed reportingsystems in 13 states to learn more about their scope and operations during the preparation of its 1999report. Since the report's release, more than half of the states have introduced legislation to addressthe problem of medical errors, and several have enacted laws to create new mandatory reportingsystems or modify existing ones. Twenty-two states now have laws or regulations that requiregeneral and acute care hospitals to report medical errors. (8) Table 1.