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Patient Safety Work Product and Its Limitations: A Discussion of Two Recent Cases

By Michael Petruccelli and Steven Osher

On July 29, 2005, President George W. Bush signed legislation known as the Patient Safety and Quality Improvement Act (PSQIA) of 2005, heralding the legislation as a critical step toward the goal of ensuring top-quality and patient-driven health care for United States citizens. This legislative initiative followed a 1999 Institute of Medicine (IOM) report, which estimated that at least 44,000, and potentially as many of 98,000, people die in U.S. hospitals each year as a result of preventable medical errors. The report, titled “To Err Is Human: Building a Safer Health System,” recommended that legislation be passed to develop a reporting system by which medical errors could be identified, analyzed, and used to prevent future medical errors.

Through the PSQIA, the mechanism for the receipt of this information was the formation of patient safety organizations and a national patient safety database. Patient safety organizations (PSOs) are defined as private organizations, or a component thereof, that are certified through a process developed through the Department of Health and Human Services (HHS). Under the Act, PSOs perform the activities of conducting and organizing, as their primary activity, efforts to improve patient safety and the quality of health care delivery, collecting and analyzing patient safety work product that is submitted by their providers, and other activities. The goal of a PSO is to improve patient safety by utilizing patient safety work product to carry out its activities and to minimize patient risk of health care errors.

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