	Introduction

In the 108th Congress, the House and Senate passed competing versions of the Patient Safetyand Quality Improvement Act ( H.R. 663 , S. 720 ). 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. (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. In an effort to encourage providers toreport errors, most states have adopted measures to protect reporting system data from use bymalpractice attorneys. To encourage reporting, the IOM further recommended that information collected undera voluntary reporting system be strictly confidential and protected from legal discovery. Providers, however, arereluctant to report adverse events. System design features, such as de-identifying data and receiving reports anonymously, mayreduce the need for strong legal protections by making it more difficult to link specific incidents toindividuals or institutions. However, in order to establish a nationwide mandatory reporting system, the IOM recommended thatCongress (1) designate the National Quality Forum as the entity responsible for issuing andmaintaining reporting standards to be used by states, (2) require health care institutions to reportstandardized information on a defined list of adverse events, and (3) provide funds and technicalexpertise to state governments to establish or improve their error reporting systems. National Medical Error Reporting Systems

There are several national voluntary reporting systems for medical errors. They include thePatient Safety Information System within the Department of Veterans Affairs (VA) and the JointCommission on Accreditation of Healthcare Organizations (JCAHO) Sentinel Events ReportingSystem. The data are analyzed by experts, and reporters receive timely feedback ofuseful information. Patient Safety and Quality Improvement Act

To encourage providers to report errors without fear of the data being used in a medicalmalpractice lawsuit, the IOM recommended that information collected under a voluntary reportingsystem be protected from legal discovery and admission as evidence in civil cases. Under the House-passed bill, PSOs would be certified by AHRQ to collect and analyzepatient safety work product submitted by providers, and to develop and disseminaterecommendations for systems-based solutions to improve patient safety and health care quality. H.R. 663 would have required AHRQ to establish a national database to receiveand analyze de-identified information submitted by PSOs. Analysis of H.R. By comparison, S. 544 would prohibit lawyers from obtaining or using patient safety data in civil,administrative, and criminal proceedings, unless a judge determined that the information containedevidence of "a wanton and criminal act to directly harm the patient." In its 1999 report, the IOM focused on protecting voluntarily reported patient safetyinformation from discovery and admission as evidence in civil and administrative proceeding, notingthat "instances of criminal prosecution for medical errors are exceptionally rare." Analysis of such information would thenbe used to identify vulnerabilities in health care systems.
In the 108th Congress, the House and Senate passed competing versions of the Patient Safetyand Quality Improvement Act ( H.R. 663 , S. 720 ), but the differencesbetween the two measures were never resolved. On March 9, 2005, the Senate Committee onHealth, Education, Labor, and Pensions unanimously approved S. 544 , which isidentical to S. 720 . The legislation would establish legal protections for data andreports on medical errors in an effort to encourage voluntary reporting of such information. Thepatient safety bills are in response to the 1999 Institute of Medicine (IOM) report To Err Is Human ,which concluded that preventable medical errors cause as many as 98,000 deaths a year. The IOMfound that medical errors are primarily the result of faulty systems, processes, and conditions thatlead people to make mistakes. It recommended establishing a national mandatory reporting systemto hold hospitals accountable for serious medical errors, as well as developing voluntary, confidentialsystems for reporting errors that result in little or no harm. Analysis of such voluntarily reported datacould be used to identify vulnerabilities in health care systems.
Twenty-two states mandate medical error reporting by hospitals. However, providers arereluctant to report adverse events in part because they fear that the information will be used inmalpractice litigation. States have sought to allay those concerns by passing laws to protect reporteddata from legal discovery and by de-identifying data and receiving reports anonymously. Suchmeasures risk limiting the usefulness of the data for research and quality management.
There are several national voluntary reporting systems for medical errors, including thePatient Safety Information System within the Department of Veterans Affairs. Analysis of these andother voluntary reporting systems -- notably the Aviation Safety Reporting System -- has identifiedseveral design features associated with effective programs. For example, the reporting processshould be user-friendly and the information kept confidential and protected from legal discovery. Also, reports should be promptly evaluated by experts who are trained to recognize underlyingsystems causes, and reporters should receive timely feedback with recommendations forsystems-based improvements.
To encourage voluntary reporting, H.R. 663 would have protected reportedinformation from legal discovery in civil and administrative proceeding, and from a Freedom ofInformation Act request. The bill required the Agency for Healthcare Research and Quality (AHRQ)to certify patient safety organizations to collect and analyze the information reported by providers. Such organizations would develop and disseminate recommendations for systems-based solutionsto improve patient safety and health care quality. H.R. 663 also would have requiredAHRQ to establish a national database to receive and analyze de-identified information submittedby patient safety organizations. S. 544 would protect information from use in criminalas well as civil and administrative proceedings, unless a judge determined that it contained evidenceof an intentional act to directly harm the patient. This report will be updated as legislative eventsin the 109th Congress warrant.