March 2008
In this issue
Patient Safety Organizations Take Shape

The establishment of Patient Safety Organizations (PSO), as called for by the 1999 Institute Of Medicine (IOM) report "To Err is Human," seems to be gaining ground. The U.S. Department of Health and Human Services (HHS) is fostering the establishment of PSOs, which are private entities intended to collect and analyze patient safety events as reported by healthcare providers. According to the IOM report, PSOs would allow for voluntary collection of patient-safety event data from providers without fear of tort liability so that providers would be encouraged to share such data freely and consistently.

The authority to recognize PSOs was established by the Patient Safety and Quality Improvement Act of 2005.

The Patient Safety Act authorizes the HHS Secretary to facilitate the development of a network of patient safety databases, to which PSOs, providers or others can voluntarily contribute nonidentifiable patient safety work product. This network will be maintained as an interactive, evidence-based management resource for providers, PSOs, and other entities.

To identify errors and their causes, Healthcare providers have implemented several approaches. They include retrospective reporting and investigation of errors and adverse events, as well as prospective analyses for identifying hazardous situations. These and other approaches contribute to data that is used to analyze patient safety risks. A variety of data structures and terminologies have been created to represent the information contained in these sources of patient safety data.

The statute directs the Agency for Healthcare Research and Quality (AHRQ) to use data from the network to analyze national and regional statistics, including trends and patterns, regarding patient safety events. Findings are to be made public and included in AHRQ's annual National Healthcare Quality Report. The public will have until April 14 of this year to comment, and their feedback will help shape the final regulation.

The proposed regulation anticipates that PSOs may be established by a wide variety of health-related organizations and quality improvement enterprises, including hospitals, nursing homes and healthcare provider systems, healthcare professional societies, academic and commercial research organizations, as well as federal, state, local and tribal governmental units that are not subject to the proposed restriction.

The administration of rules for listing PSOs will be administered by AHRQ while the Office for Civil Rights will enforce the confidentiality provisions of the act. Prior to publication of the final rule, the department will issue guidance for entities wishing to become PSOs.

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