RL31983
Patient Safety: Legislation to Promote Voluntary Reporting of Medical Errors
November 26, 2003

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Thurgood Marshall Law Library/University of Maryland School of Law

Summary:

On July 23, 2003, the Senate Committee on Health, Education, Labor, and Pensions (HELP) approved the Patient Safety and Quality Improvement Act (S. 720). The legislation would establish federal evidentiary privilege and confidentiality protections for data and reports on medical errors in an effort to encourage voluntary reporting of such information. The House passed comparable legislation (H.R. 663) on March 12, 2003. Congressional interest in patient safety grew out of 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 IOM emphasized that medical errors are primarily the result of faulty systems, processes, and conditions that lead people to make mistakes. It recommended establishing a national mandatory reporting system to hold hospitals accountable for serious medical errors, as well as developing voluntary, confidential systems for reporting errors that result in little or no harm. Analysis of such voluntarily reported data could be used to identify vulnerabilities in health care systems. Twenty-one states mandate medical error reporting by general and acute care hospitals. However, providers are reluctant to report adverse events because they fear that the information will be used in malpractice litigation. States have sought to allay those concerns by passing laws to protect reported data from legal discovery and by de-identifying data and receiving reports anonymously. Such measures risk limiting the usefulness of the data for research and quality management. There are several national voluntary reporting systems for medical errors, including the Patient Safety Information System within the Department of Veterans Affairs. Analysis of these and other voluntary reporting systems -- notably the Aviation Safety Reporting System -- has identified several design features associated with effective programs. For example, the reporting process should 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 underlying systems causes, and reporters should receive timely feedback with recommendations for systems-based improvements. To encourage voluntary reporting, H.R. 663 would protect reported information from legal discovery in civil and administrative proceeding, and from a Freedom of Information Act request. The bill would require 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 solutions to improve patient safety and health care quality. H.R. 663 would also require AHRQ to establish a national database to receive and analyze de-identified information submitted by patient safety organizations. The Senate bill (S. 720) would protect information from use in criminal as well as civil and administrative proceedings, unless a judge determined that it contained evidence of an intentional act to directly harm the patient. This report will be updated as legislative events warrant.