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HHS/AHRQ

RIN: 0919-AA01

Publication ID: Spring 2009

Title: Patient Safety and Quality Improvement Act of 2005 Rules
Abstract: The proposed rules to implement the Patient Safety and Quality Improvement Act of 2005 establish a framework in which hospitals, doctors, and other health care providers may voluntarily contract with Patient Safety Organizations (PSOs) to report and analyze health care errors. Providers contract with PSOs for expertise in the collection of patient safety event reports and analysis of the cause of adverse events. The proposed rules outline the requirements that entities must meet and certify to the Secretary for acceptance as a PSO. The proposed rules establish legal boundaries of privilege and confidentiality within which reporting and analysis occurs, and sets forth procedures for the imposition of civil money penalties for the knowing or reckless disclosure of patient safety work product.
Agency: Department of Health and Human Services(HHS)	Priority: Economically Significant
RIN Status: Previously published in the Unified Agenda	Agenda Stage of Rulemaking: Completed Actions
Major: Yes	Unfunded Mandates: No
CFR Citation: 42 CFR 3
Legal Authority: 42 USC 299b-12 to 299b-26 PL 109-41

Legal Deadline: None

Timetable:

Action	Date	FR Cite
NPRM	02/12/2008	73 FR 8112
NPRM Comment Period End	04/14/2008
Final Action	11/21/2008	73 FR 70732

Regulatory Flexibility Analysis Required: No	Government Levels Affected: None
Small Entities Affected: No	Federalism: No
Included in the Regulatory Plan: No
RIN Data Printed in the FR: No
Agency Contact: William Munier Department of Health and Human Services Agency for Healthcare Research and Quality 540 Gaither Road, Rockville, MD 20850 Phone:301 427-1219 Fax:301 443-0251 Email: william.munier@ahrq.hhs.gov