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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:

At least 44,000 people, and potentially as many as 98,000 people, die in U.S. hospitals each year as a result of preventable medical errors.
The total national cost of preventable adverse events, including lost income, lost household productivity, permanent and temporary disability, and health care costs, to be estimated as between $17 billion and $29 billion, of which health care costs represent one-half.
The majority of medical errors do not result from individual recklessness or the actions of a particular group; rather, most errors are caused by faulty systems, processes, and conditions that lead people to make mistakes or fail to prevent adverse events.

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:

These protections do not exist in all states
Typically, these protections only apply to peer review in hospitals and do not cover other health care settings
These protections seldom enable health care systems to pool data or share experience among facilities

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 legislation fosters a culture of safety by establishing strong Federal confidentiality and privilege protections for information that physicians, other clinicians, and provider organizations assemble and develop and for deliberations and analyses regarding quality and safety. This means that there will now be a uniform set of Federal protections that will be available in all States and U.S. territories, and that extend to all health care practitioners and institutional providers. The fact that these protections are national will be especially important to multifacility health care systems that will now be able to share data within a protected legal environment, both within and across States.
The legislation is expected to accelerate the speed with which solutions can be identified for the risks and hazards associated with patient care. While it has long been recognized that the underlying causes of risks and hazards in patient care can best be recognized through the aggregation of significant numbers of individual patient safety events, it has often been difficult to aggregate sufficient numbers of events in a protected legal environment. The Patient Safety Act advances this goal by authorizing the Secretary of Health and Human Services to recognize or "list" organizations: Patient Safety Organizations (PSOs), with expertise in the analysis of risks and hazards in patient care. The law encourages PSOs to aggregate information from multiple clients as well as across PSOs, and they can contribute nonidentifiable information to a network of patient safety databases.

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).

Who can become a PSO? Both public and private entities, either for-profit, or not-for-profit, can seek "listing" as a PSO. The statute prohibits insurers and components of insurers from becoming PSOs, and the NPRM would prohibit public or private entities with regulatory authority over providers (such as accreditation and licensure bodies) from becoming PSOs. The preamble seeks comment on whether the regulatory prohibition should be broadened to preclude components of regulatory entities from becoming PSOs.

Is the process complicated? The process is simple. An entity simply certifies that it is in compliance with the requirements for becoming a PSO. These requirements track the statute and are described in section 3.102 of the NPRM. AHRQ can spot-check PSO compliance with the statute and the regulation.

Will PSOs receive Federal funding or direction? Entities listed as PSOs receive no Federal funding; their viability depends upon the marketplace (e.g., contracts with providers, self-funded components, or private-sector grants).

What if a problem emerges? The NPRM proposes a nonadversarial process for working with a PSO if it falls out of compliance with the requirements. Only when a PSO does not work in good faith to correct a deficiency—or the deficiency is so grave that it cannot be corrected—will the Secretary turn to the revocation process (see section 3.108).

Can a PSO be delisted? A PSO can be "delisted" by the Secretary: (1) for "cause" because the PSO cannot or would not correct a deficiency; (2) the PSO asks to relinquish its status as a PSO during its 3-year period of listing; or (3) the PSO permits its 3-year listing to expire without submitting a timely certification for continued listing.

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).