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U.S. Department of Health and Human Services www.hhs.gov
Agency for Healthcare Research Quality www.ahrq.gov

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PSO Overview

Background

The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act) is a response to the Institute of Medicine's landmark report, To Err is Human: Building a Safer Health System. This report found that:

A major impediment to the identification of the systemic risks and hazards associated with the delivery of health care services is the reluctance of physicians and other clinicians to participate in quality review activities for fear of legal liability, professional sanctions, or injury to their reputations. Traditional State-based legal protections for such health care quality improvement activities, collectively known as peer review protections, are limited in scope:

In most states, the peer review privilege, if available, is waived if peer review information is transmitted outside an individual hospital.

The limited nature of existing State protection contributes to a second major impediment: the inability to aggregate sufficient numbers of patient safety events to identify and mitigate underlying patterns of causal factors (i.e., risks and hazards) that can reduce patient safety.

Purpose of the Legislation

Drawing on the broad framework advanced by the Institute of Medicine, the Patient Safety Act addresses these problems. The goals of the legislation are to increase the willingness of physicians and other clinicians to participate in voluntary, provider-driven initiatives to improving the quality, safety, and outcomes of patient care; to promote more rapid learning about the underlying causes of risks and harms in the delivery of health care; and to share those findings widely, and thus speed the pace of improvement. The Patient Safety Act advances these goals in two broad ways.

The Patient Safety Act is expected to foster routine reporting to PSOs of data on patient safety events in sufficient numbers so that valid and reliable analyses can be completed far more quickly. The insights provided by theses analyses should enable providers to more effectively and efficiently target their efforts to improve patient safety.

Patient Safety Organization Operations: Highlights of the Notice of Proposed Rulemaking

The Notice of Proposed Rulemaking (NPRM) proposes how the Department intends to implement the Patient Safety Act and seeks comments on its proposed approach. The Agency for Healthcare Research and Quality (AHRQ) will implement the provisions relating to Patient Safety Organizations (Subpart B of the NPRM).

Confidentiality and Privilege

The Patient Safety Act provides two types of protection for certain information: confidentiality protections and privilege protections. Privilege protections, which will be enforced by the judicial system, limit or forbid the use of protected information in criminal, civil, administrative, or other proceedings. The Office for Civil Rights (OCR) will administer and enforce the provisions protecting the confidentiality of patient safety work product (Subparts C and D of the NPRM). For information about OCR, visit their Web site at: http://www.hhs.gov/ocr/psqia/.

Network of Patient Safety Databases

The Patient Safety Act authorizes the Secretary to facilitate the development of a network of patient safety databases, to which PSOs, providers, or others can voluntarily contribute nonidentifiable patient safety work product. This network will be maintained as an interactive, evidence-based management resource for providers, PSOs, and other entities. The statute directs AHRQ to use data from the network to analyze national and regional statistics, including trends and patterns, regarding patient safety events. Findings are to be made public and included in AHRQ's annual National Healthcare Quality Report.

AHRQ has begun development of the network and will post periodic updates on its progress on this Web site.

Proposed Regulations for Patient Safety Organizations (PSOs) Audio Call Transcript

Audio Call Transcript on Proposed Regulations for PSOs
(Friday, February 29, 2008).

AHRQ Audio Podcast

"Healthcare 411" Audio Podcast addresses PSO Proposed Regulation
(Wednesday, February 27, 2008 12:30 PM)
(Select to read transcript).


PSO Home
Patient Safety Organizations (PSO) Overview
Patient Safety and Quality Improvement Act (PSQIA)
Notice of Proposed Rulemaking (NPRM)
How to Comment on the Notice of Proposed Rulemaking
Frequently Asked QRulemaking Process
Office for Civil Rights (OCR)
Contact PSO Office
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