HHS Guidance

Patient Safety and Quality Improvement Act of 2005—HHS Guidance Regarding Patient Safety Work Product and Providers’ External Obligations (May 2016)

SUMMARY: 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–b-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 Patient Safety and Quality Improvement Act of 2005—Guidance Regarding Patient Safety Work Product and Providers’ External Obligations (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). This Guidance also clarifies how providers can satisfy external obligations related to information collection activities consistent with the Patient Safety Act and Patient Safety Rule.

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.

A PDF of the FDA Guidance for PSOs is available to download.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)

SUMMARY:  The Guidance states that a PSO that is a component of a parent organization that includes an FDA-regulated entity cannot create a conflict of interest for its parent organization by extending PSWP protections to information that the regulated entity is required to report to the FDA under the FDCA. Therefore, for such an entity to become listed as a component PSO, the entity must agree to disclose PSWP to both its parent and the FDA, when required.
The Patient Safety Guidance applies to:
  1. All entities that have mandatory FDA-reporting obligations under the Food, Drug and Cosmetic Act (FDCA) or
  2. Entities that are organizationally related to such FDA-regulated reporting entities (e.g., parent organizations, subsidiaries, sibling organizations).