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The Rise of Patient Safety Organizations

BY David S. Ivill
November 25, 2009

The 1999 Institute of Medicine (IOM) report, “To Err Is Human,” brought patient safety to the forefront with its alarming findings, most jarringly encapsulated in its conclusion that medical error-related deaths in the United States are the equivalent of crashing one jumbo jet per day. L.T. Kohn, J.M. Corrigan, and M.S. Donaldson, eds., “To Err Is Human: Building a Safer Health System” (National Academies Press, 1999). According to the IOM's report, one factor underlying the high rate of medical errors has been a reluctance on the part of providers to identify and address medical errors due to concerns that such information would be used against them in medical malpractice lawsuits or professional disciplinary actions.

The Patient Safety and Quality Improvement Act

The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act or Act) was designed to address this concern by creating a mechanism for the reporting and sharing of patient safety information among providers without the fear of liability. See 42 U.S.C. ” 299b-21'299b-26 (2006). To that end, the Patient Safety Act authorizes the creation of a new type of entity, a patient safety organization (PSO), to receive and analyze information relating to patient safety. The Act confers broad federal privilege and confidentiality protections to this information, referred to as “patient safety work product,” with significant penalties for breaches. The PSO program is administered by the Agency for Healthcare Research and Quality (AHRQ) and enforced by the Office of Civil Rights. AHRQ published a final rule implementing the Patient Safety Act in November 2008. See 73 Fed. Reg. 70,732 (Nov. 21, 2008). There are currently 69 PSOs listed with the AHRQ.

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