Patient safety organizations
This article was originally published in The Gray Sheet
Executive Summary
HHS on Nov. 21 finalized a 1regulation establishing patient safety organizations - third-party groups certified by the government to accept patient safety event information from health care practitioners on a confidential basis. Required by the Patient Safety and Quality Improvement Act of 2005, PSOs are intended to give practitioners a way to report events without fear that the information will be used against them in lawsuits or professional sanctions. They do not negate FDA adverse event reporting requirements for devices and drugs (2"The Gray Sheet" Feb. 18, 2008, p. 7)