Abstract

After the passage of the Patient Safety and Quality Improvement Act of 2005, the Federal Government has published a final rule that aims to encourage health providers to report, learn from, and, ultimately, reduce the incidence of patient safety events. The final rule is broad in scope: it describes the roles and activities of new patient safety organizations (PSOs) and establishes a process to report, protect, and disseminate safety information. In the interim, guidelines that describe how organizations can become PSOs were released in October by the U.S. Department of Health and Human Services (HHS). 1 These guidelines will be in effect until 60 days after the date of publication of the final rule in November. Under these guidelines, HHS’ Agency for Healthcare Research and Quality (AHRQ) was authorized to receive applications from qualified entities that seek to become PSOs. Ten organizations were officially listed as PSOs on November 5, 2008, and 5 more were listed on November 19. Qualified organizations can continue to submit applications through the interim period. There is no limit to the number of organizations that may apply to become PSOs. THE ROLE AND RATIONALE Private voluntary entities, PSOs were called for by the Institute of Medicine and established by Congress in the 2005 law. 2 They are intended to address a major stumbling block to sustained quality improvement: a lack of uniform Federal standards for privilege and confidentiality of information about patient safety events. Existing state-based legal protections for quality improvement activities, known as peer review protections, do not exist in all states and cover only review of hospital-based care, not services provided in other health care settings. The result has been a pervasive fear of legal liability and sanctions among physicians, other health care providers, and health care organizations. A second related barrier to quality improvement that the final rule seeks to address is the inability of health care providers to collect and share data about patient safety events with other facilities locally, within, and across states. This limitation makes it harder for providers and organizations to identify and adopt patterns of practice that reduce the risk of medical errors.

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