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Resources About the Patient Safety and Quality Improvement Act of 2005

Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act)

The Patient Safety Act (42 U.S.C. sections 299b-21 to 299b-26) is the Federal law that created patient safety organizations (PSOs), confidentiality and privilege protections for information meeting the definition of patient safety work product, authority for AHRQ's development of the Common Formats, and the network of patient safety databases (NPSD).

Resources on the Patient Safety Act page:

  • Information about the Patient Safety Act
  • The Patient Safety Act
  • Information about the Report to Congress required by the Patient Safety Act 

Patient Safety and Quality Improvement Rule (Patient Safety Rule)

The Patient Safety Rule (42 CFR Part 3) is the Federal regulation that implements the Patient Safety Act.

Resources on the Patient Safety Rule page:

  • Information about the Patient Safety Rule
  • The Patient Safety Final Rule
  • The Notice of Proposed Rulemaking for the Patient Safety Rule

Department of Health and Human Services (HHS) Guidance

HHS Guidance documents explain, in general, how HHS interprets some aspects of the Patient Safety Act.

Resources on the HHS Guidance page:

  • Information about each HHS Guidance document
  • HHS Guidance Regarding Patient Safety Work Product and Providers' External Obligations (May 2016)
    • AHRQ presentation on May 2016 HHS Guidance
  • HHS Guidance Regarding Patient Safety Organizations' Reporting Obligations to the Food and Drug Administration (FDA)

Guides

Guides provide helpful information about various aspects of the PSO listing requirements.

Resources on the Guides page:

  • PSO Listing Guide (March 2022)
  • Guides for PSOs and Providers for Determining Parent Organization and Affiliated Providers (June 2016)
  • PSO Policies and Procedures – Topics to Address (April 2019)
  • What is the Role of the PSO Authorized Official (June 2017)
  • Working With a PSO - One Approach: Video
  • Working With a PSO - One Approach: Diagram (Flow Chart illustrating concepts related to the development and exchange of patient safety work product)
  • FAQs

Other Educational Materials

Educational materials to help promote understanding of the Patient Safety Act and PSOs.

Resources on the Educational Materials page:

  • Brochure—Choosing a Patient Safety Organization (March 2020)
  • PSO Program Common Terms and Acronyms (March 2017)
  • Webinar: Working With Patient Safety Organizations (PSOs): The Value for Hospitals During COVID-19 and Beyond (November 2020)
  • Webinar: Benefits of AHRQ Patient Safety Organizations (PSOs): Success Stories from Hospital PSO Members (June 2015)
  • Quiz and answer sheet about PSOs and the requirements of the Patient Safety Act and Rule (January 2020)

 

Page last reviewed August 2022
Page originally created August 2022

Internet Citation: Resources About the Patient Safety and Quality Improvement Act of 2005. Content last reviewed August 2022. Agency for Healthcare Research and Quality, Rockville, MD.
https://pso.ahrq.gov/resources/psqia

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