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GAO-09-229R 1 (2008-12-08)

handle is hein.gao/gaobadwwa0001 and id is 1 raw text is: I GA 0 T V M Accountability * Integrity * Reliability United States Government Accountability Office Washington, DC 20548 B-317509 December 8, 2008 The Honorable Edward M. Kennedy Chairman The Honorable Michael B. Enzi Ranking Minority Member Committee on Health, Education, Labor, and Pensions United States Senate The Honorable John D. Dingell Chairman The Honorable Joe Barton Ranking Minority Member Committee on Energy and Commerce House of Representatives Subject: Department of Health and Human Services: Patient Safety and Quality Improvement Pursuant to section 801(a)(2)(A) of title 5, United States Code, this is our report on a major rule promulgated by the Department of Health and Human Services (HHS), entitled Patient Safety and Quality Improvement (RIN: 0919-AAO1). We received the rule on November 20, 2008. It was published in the Federal Register as a final rule on November 21, 2008, with a stated effective date of January 19, 2009. 73 Fed. Reg. 70,732. The final rule implements certain provisions of the Patient Safety and Quality Improvement Act of 2005, Pub. L. No. 109-41, 119 Stat. 424 (July 29, 2005). The rule establishes a framework by which hospitals, doctors, and other health care providers may voluntarily report information to Patient Safety Organizations (PSOs), on a privileged and confidential basis, for the aggregation and analysis of patient safety events. The final rule outlines the requirements that entities must meet to become PSOs and the processes by which HHS will review and accept certifications and list PSOs. It also describes the privilege and confidentiality protections for the information that is assembled and developed by providers and PSOs, the exceptions to these privilege and confidentiality protections, and the procedures for the imposition of civil money penalties for the knowing or reckless impermissible disclosure of patient safety work product. GAO-09-229R

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