Patient Safety and Quality Improvement Act of 2005—HHS Guidance Regarding Patient Safety Work Product and Providers' External Obligations (May 2016)
This notice sets forth guidance for patient safety organizations (PSOs) and providers regarding questions that have arisen about the Patient Safety and Quality Improvement Act of 2005, 42 USC 299b-21 to 299b-26 (Patient Safety Act), and its implementing regulation, the Patient Safety and Quality Improvement Final Rule, 42 CFR Part 3 (Patient Safety Rule). In particular, this guidance is intended to provide clarity in response to recurring questions about what information that a provider creates or assembles can become patient safety work product (PSWP). It also clarifies how providers can satisfy external obligations related to information collection activities consistent with the Patient Safety Act and Patient Safety Rule.
Download the Guidance (Federal Register) (PDF, 0.2 MB)
Additional Resource: AHRQ Presentation on HHS Guidance
This presentation is intended to provide general information regarding the AHRQ Patient Safety Organization (PSO) program and should not be construed as official HHS or AHRQ policy or guidance, nor should it be relied upon as a substitute for familiarity with the Federal laws and regulations applicable to patient safety organizations, including the Patient Safety and Quality Improvement Act (42 USC 299b–21, et seq.) and the Patient Safety and Quality Improvement Final Rule (42 CFR Part 3). The information presented is not legal advice, is not to be acted on as such, may not be current, and is subject to change without notice.
Download the AHRQ presentation on HHS Guidance (PDF, 0.2 MB)
Patient Safety and Quality Improvement Act of 2005—HHS Guidance Regarding Patient Safety Organizations' Reporting Obligations to the Food and Drug Administration (FDA) (December 2010)
The purpose of this guidance is to address questions that have arisen regarding the obligations of PSOs where they or the organization of which they are a part are legally obligated under the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 301 et seq., and its implementing regulations to report certain information to the Food and Drug Administration (FDA) and to provide FDA with access to its records, which may contain patient safety work product.
This guidance applies to all entities that seek to be or are PSOs that:
- have mandatory FDA-reporting obligations under the Food, Drug and Cosmetic Act (FDCA) or
- are organizationally related to such FDA-regulated reporting entities (e.g., parent organizations, subsidiaries, sibling organizations).
Download the HHS Guidance Regarding Patient Safety Organizations' Reporting Obligations to the FDA (PDF, 0.4 MB)