Summary

GAO reviewed the Department of Health and Human Services' (HHS) new rule on patient safety and quality improvement. GAO found that (1) the final rule implements certain provisions of the Patient Safety and Quality Improvement Act of 2005, establishes a framework by which hospitals, doctors, and other health care providers may voluntarily report information to Patient Safety Organizations (PSOs), on a privileged and confidential basis, for the aggregation and analysis of patient safety events, outlines the requirements that entities must meet to become PSOs and the processes by which HHS will review and accept certifications and list PSOs, and describes the privilege and confidentiality protections for the information that is assembled and developed by providers and PSOs, the exceptions to these privilege and confidentiality protections, and the procedures for the imposition of civil money penalties for the knowing or reckless impermissible disclosure of patient safety work product; and (2) with the exception of the delay in the effective date, HHS complied with the applicable requirements.