Guidance for Patient Safety Rule

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.

HHS Guidance Regarding Patient Safety Organizations’ Reporting Obligations to the 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).