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Federal government seeks to create patient safety organizations to collect and analyze adverse event data

Patient Safety Monitor Alert, February 13, 2008

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The Department of Health and Human Services (HHS) is accepting comment on a proposed rule that would establish a framework for the voluntary reporting of information to patient safety organizations (PSO) for the purpose of analyzing "patient safety events." According to the proposed rule published in the Federal Register, reporting can be done by hospitals, physicians, and other healthcare providers "on a privileged and confidential basis." This proposed rule comes out of the Patient Safety and Quality Improvement Act of 2005.

The proposed regulation also details requirements that entities must meet to become PSOs. Also, the proposed regulation establishes confidentiality protections for information gathered and developed by providers and PSOs (called "patient safety work product" by the Patient Safety Act) "and the procedures for the imposition of civil money penalties for the knowing or reckless impermissible disclosure of patient safety work product," according to the Federal Register posting.

Members of the public can comment on the proposed rule until April 14, 2008. More information can be found on the AHRQ's Web site, and by clicking here.

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