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Legislation, Regulations, and Guidance

Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act): An Overview

The goals of the Patient Safety Act are to encourage the expansion of voluntary, provider-driven initiatives to improve the quality and safety of health care; to promote rapid learning about the underlying causes of risks and harms in the delivery of health care; and to share those findings widely, thus speeding the pace of improvement. The Patient Safety Act:

To read the Patient Safety Act, go to http://www.pso.ahrq.gov/statute/pl109-41.htm

The Patient Safety Rule

In order to implement the Patient Safety Act, the Department of Health and Human Services (HHS) issued the Patient Safety and Quality Improvement Final Rule (Patient Safety Rule), which became effective on January 19, 2009. To read the Patient Safety Rule, go to: Patient Safety Rule (PDF file, 760 KB;. PDF Help).

The Patient Safety Rule establishes a framework by which hospitals, doctors, and other health care providers may voluntarily report information to PSOs, on a privileged and confidential basis, for the aggregation and analysis of patient safety events. In addition, the Patient Safety Rule outlines the requirements that entities must meet to become PSOs and the process by which the HHS Secretary will review and accept certifications and list PSOs. The Patient Safety Rule has the force of Federal law.

The Patient Safety Rule includes a summary of and responses to the Notice of Proposed Rulemaking (NPRM) released by HHS on February 12, 2008. Since the NPRM contains HHS' initial thinking regarding the rule, it provides context for understanding the evolution of the requirements that were incorporated into the Patient Safety Rule. The discussion in the NPRM may be helpful in understanding those provisions of the Patient Safety Rule that were adopted without change from the NPRM. To read the NPRM, go to: NPRM (PDF file, 421 KB; PDF Help).

Patient Safety Guidance

On December 30, 2010, HHS issued Guidance to address questions that have arisen regarding the obligations of PSOs where they or the organization of which they are a part are legally obligated under the Federal Food, Drug, and Cosmetic Act (FDCA) and its implementing regulations to report certain information to the Food and Drug Administration (FDA) and to provide FDA with access to its records, including access during an inspection of its facilities. This Guidance applies to all entities that seek to be or are PSOs or component PSOs that have mandatory FDA-reporting obligations under the FDCA and its implementing regulations (“FDA-regulated reporting entities”) or are organizationally related to such FDA-regulated reporting entities (e.g., parent organizations, subsidiaries, sibling organizations). To read the Patient Safety Guidance, go to: Department of Health and Human Services Guidance Regarding Patient Safety Organizations' Reporting Obligations and the Patient Safety and Quality Improvement Act of 2005 (PDF File, 201 KB; PDF Help).

Additional information:

Press Release for Patient Safety Rule:

In January 2010, the United States Government Accountability Office (GAO) issued a report to Congress on the effectiveness of the Patient Safety Act. The GAO report describes the progress made by AHRQ in implementing the Patient Safety Act; to view the GAO report, go to http://www.gao.gov/products/GAO-10-281.

Press Release for Patient Safety Rule:
Patient Safety Rule Issued for Patient Safety Organizations

To be notified of these developments electronically, please subscribe to PSO E-mail updates at: Red Envelope Patient Safety Organization E-mail Updates

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