HHS Proposes Rule to Set Up Patient Safety Organizations

The Department of Health and Human Services yesterday proposed a rule that would foster Patient Safety Organizations (PSOs) that would be private entities collecting and analyzing patient safety events reported by health care providers. This would encourage voluntary reporting of patient safety events without fear of new tort liability, HHS said.

"Patient Safety Organizations will help make health care safer for all Americans," HHS Secretary Mike Leavitt said. "By making it easier for patient safety events to be reported and the lessons learned from them to be shared more broadly, patients will ultimately receive safer health care."

The authority to list, or formally recognize, PSOs was established by the Patient Safety and Quality Improvement Act of 2005. The proposed rule describes how an organization may become a PSO and explains how clinicians will be able to report patient safety events confidentially, how the data will be shared with others engaging in patient safety work while remaining privileged and confidential, and how clinicians will receive feedback on ways to improve patient safety.

The Agency for Healthcare Research and Quality, a unit of HHS, will administer the rules for listing qualified PSOs. The HHS Office for Civil Rights will enforce the confidentiality provisions of the act. HHS also said it will soon issue guidance that would allow entities to be listed as PSOs. AHRQ will publish information on national and regional statistics, including trends and patterns of patient safety events, in its annual National Healthcare Quality Report.

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