Final Regulation to implement and enforce the Patient Safety and Quality Improvement Act of 2005

http://edocket.access.gpo.gov/2008/pdf/E8-27475.pdf

The final regulation to implement and enforce the Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act) has been published in the Federal Register today. In April 2006, Secretary Leavitt delegated to OCR the authority to implement and enforce the confidentiality protections of the Patient Safety Act in conjunction with the Agency for Healthcare Research and Quality (AHRQ), which is responsible for administration of the Patient Safety Organization (PSO) requirements. On February 12, of this year, AHRQ and OCR published the proposed regulation for public comment. On October 8, of this year, AHRQ and OCR published interim guidance to permit AHRQ to begin listing PSOs prior to the effective date of the final regulation. On January 19, 2009, the final regulation will be effective and supersede the interim guidance.



The final regulation establishes the procedures and requirements for the listing and operation of PSOs, as well as the privilege and confidentiality protection for patient safety work product. The final rule makes several modifications to the proposed rule, in particular adding new requirements for PSOs and clarifying how information is collected to allow efficiencies in provider operations when collecting similar information for different purposes.



OCR’s enforcement responsibility includes the imposition of a civil money penalty for a knowing or reckless impermissible disclosure of patient safety work product. A civil money penalty may be imposed in an amount up to $10,000 for each violation.



The Patient Safety Act recognizes certain provisions of the HIPAA Privacy Rule are implicated by covered entity providers seeking the protections of the Patient Safety Act. The preamble to the final regulation describes how the HIPAA Privacy Rule disclosure permissions operate in conjunction with the patient safety disclosure permissions.



You may review the final regulation in the Federal Register (http://edocket.access.gpo.gov/2008/pdf/E8-27475.pdf).