Abstract

nurses, physicians, and other health care providers reduce the incidence of patient safety events and maintain confidentiality about those events will move into high gear in 2009. On January 19, 2009, the final rule that establishes the roles and activities of these new entities, known as Patient Safety Organizations (PSOs), took effect. Published by the US Department of Health and Human Services (HHS), the rule describes how PSOs can work with health care providers and organizations to collect and analyze data, and reduce the incidence of patient care risks and hazards. The creation of PSOs was called for by Congress as part of the Patient Safety and Quality Improvement Act of 2005. The Agency for Healthcare Research and Quality (AHRQ) has responsibility for PSO operations, whereas the HHS’ Office for Civil Rights enforces confidentiality provisions. Confidentiality about reporting pa tient safety events is important, because according to the Institute of Medicine’s landmark report To Err is Human, clinicians and health care organizations are often fearful about providing information about errors and near misses be cause of the potential for litigation. The confidentiality provisions contained in the final PSO rule apply to both patients and health care providers. Interim guidelines issued shortly before the final rule was published gave the AHRQ the authority to receive applications from qualified entities seeking to be designated as PSOs. As of December 10, 2008, 25 organizations were officially listed as PSOs. PSOS: THEIR ROLE AND RATIONALE Patient Safety Organizations were called for by the Institute of Medicine and established by Congress in the 2005 law. They are intended to address a major stumbling block to sustained quality improvement—a lack of uniform, federal standards for 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 only cover hospital-based care, not services provided in nonhospital settings. As a result, health care pro viders and organizations have maintained a pervasive fear of legal liability and sanctions. A second related barrier to quality improvement that the rule sought to address is the inability of health care providers to collect and share data about patient safety events with other facilities, both locally and across states. This is because state peer review protections are limited to the specific hospital, which makes it harder for providers and organizations to identify and adopt patterns of practice that have been shown to reduce the risk of medical errors.

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