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Agency for Healthcare Research Quality

The Patient Safety and Quality Improvement Act of 2005

The Patient Safety and Quality Improvement Act of 2005 (Public Law 109-41), signed into law on July 29, 2005, was enacted in response to growing concern about patient safety in the United States and the Institute of Medicine's 1999 report, To Err is Human: Building a Safer Health System. The goal of the Act is to improve patient safety by encouraging voluntary and confidential reporting of events that adversely affect patients.

The Patient Safety and Quality Improvement Act signifies the Federal Government's commitment to fostering a culture of patient safety. It creates Patient Safety Organizations (PSOs) to collect, aggregate, and analyze confidential information reported by health care providers. Currently, patient safety improvement efforts are hampered by the fear of discovery of peer deliberations, resulting in under-reporting of events and an inability to aggregate sufficient patient safety event data for analysis. By analyzing patient safety event information, PSOs will be able to identify patterns of failures and propose measures to eliminate patient safety risks and hazards.

Many providers fear that patient safety event reports could be used against them in medical malpractice cases or in disciplinary proceedings. The Act addresses these fears by providing Federal legal privilege and confidentiality protections to information that is assembled and reported by providers to a PSO or developed by a PSO ("patient safety work product") for the conduct of patient safety activities. The Act also significantly limits the use of this information in criminal, civil, and administrative proceedings. The Act includes provisions for monetary penalties for violations of confidentiality or privilege protections.

Additionally, the Act specifies the role of PSOs and defines "patient safety work product" and "patient safety evaluation systems," which focus on how patient safety event information is collected, developed, analyzed, and maintained. In addition, the Act has specific requirements for PSOs, such as:

  • PSOs are required to work with more than one provider.
  • Eligible organizations include public or private entities, profit or not-for-profit entities, provider entities, such as hospital chains, and other entities that establish special components.
  • Ineligible organizations include insurance companies or their affiliates.

Finally, the Act calls for the establishment of a Network of Patient Safety Databases (NPSD) to provide an interactive, evidence-based management resource for providers, PSOs, and other entities. It will be used to analyze national and regional statistics, including trends and patterns of patient safety events. The NPSD will employ common formats (definitions, data elements, and so on) and will promote interoperability among reporting systems. The Department of Health and Human Services will provide technical assistance to PSOs.

For Additional Information

Sign up for AHRQ's Patient Safety Organizations E-mail updates to receive automatic notifications of new and updated information relating to Patient Safety Organizations.

To contact PSO Office staff, go to the PSO site at

Current as of June 2008

Internet Citation:

The Patient Safety and Quality Improvement Act of 2005. Overview, June 2008. Agency for Healthcare Research and Quality, Rockville, MD.


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