Agency for Healthcare Research and Quality September 21, 2009 – Federal Register Recent Federal Regulation Documents

AHRQ is announcing the availability of a document entitled: ``Patient Safety Organizations: A Compliance Self-Assessment Guide.'' The Patient Safety and Quality Improvement Act of 2005, Public Law 109- 41, 42 U.S.C. 299-b21b-26 (Patient Safety Act) provides for the formation of Patient Safety Organizations (PSOs), which collect, aggregate, and analyze confidential information regarding the quality and safety of healthcare delivery. The Patient Safety and Quality Improvement Final Rule (Patient Safety Rule) (42 CFR part 3) authorizes AHRQ, on behalf of the Secretary of HHS, to: list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing; and request additional information and conduct reviews (including announced or unannounced site visits) to assess PSO compliance. To assist PSOs in making the required attestations and preparing for a compliance review, AHRQ developed the sample questions in this guide to encourage each PSO to take a thorough and systematic approach to compliance. The guide recognizes that each PSO's approach to compliance may be different based upon the specific mission it has chosen, the specific activities and expertise it offers to healthcare providers, and its size and mode of operation. Thus, these questions are merely illustrative; some questions will not be applicable or even appropriate for every PSO. The guide does not establish new standards or requirements beyond those that are established by the Patient Safety Rule.