Patient Safety and Quality Improvement Act of 2005-HHS Guidance Regarding Patient Safety Work Product and Providers' External Obligations

This guidance 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 U.S.C. 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 clarify what information that a provider creates or assembles can become patient safety work product (PSWP) in response to recurring questions. 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.