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Patient Safety Organizations: A Compliance Self-Assessment Guide

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Information about this document as published in the Federal Register.

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Agency for Healthcare Research and Quality (AHRQ), HHS.


Notice of Availability—Patient Safety Organizations: A Compliance Self-Assessment Guide.


AHRQ is announcing the availability of a document entitled: “Patient Safety Organizations: A Compliance Self-Assessment Guide.” The Patient Safety and Quality Improvement Act of 2005, Public Law 109-41, 42 U.S.C. 299-b21—b-26 (Patient Safety Act) provides for the formation of Patient Safety Organizations (PSOs), which collect, aggregate, and analyze confidential information regarding the quality and safety of healthcare delivery. The Patient Safety and Quality Improvement Final Rule (Patient Safety Rule) (42 CFR part 3) authorizes AHRQ, on behalf of the Secretary of HHS, to: list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing; and request additional information and conduct reviews (including announced or unannounced site visits) to assess PSO compliance. To assist PSOs in making the required attestations and preparing for a compliance review, AHRQ developed the sample questions in this guide to encourage each PSO to take a thorough and systematic approach to compliance. The guide recognizes that each PSO's approach to compliance may be different based upon the specific mission it has chosen, the specific activities and expertise it offers to healthcare providers, and its size and mode of operation. Thus, these questions are merely illustrative; some questions will not be applicable or even appropriate for every PSO. The guide does not establish new standards or requirements beyond those that are established by the Patient Safety Rule.


Availability of resource.


“Patient Safety Organizations: A Compliance Self-Assessment Guide” can be accessed electronically at the following HHS Web site: http://www.pso.ahrg.qov/​index.html.

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Diane Cousins, RPh., Center for Quality Improvement and Patient Safety, AHRQ, 540 Gaither Road, Rockville, MD 20850; Telephone (toll free): (866) 403-3697; Telephone (local): (301) 427 1111; TTY (toll free): (866) 438-7231; TTY (local): (301) 427-1130; E-mail: pso@ahrq.hhs.qov.

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The Patient Safety Act establishes a framework by which healthcare providers can report information voluntarily to PSOs, on a privileged and confidential basis, for the aggregation and analysis of patient safety events and quality concerns. A PSO is an entity listed by the Secretary of HHS, which has a primary focus to conduct activities to improve patient safety and the quality of healthcare delivery.

The requirements governing PSOs are set forth in subpart B of the Patient Safety Rule. These include: the requirements that an entity must meet to become, and remain listed, as a PSO; the procedures and processes for assessing an entity's eligibility; the processes for ensuring a PSO's compliance with the requirements of the Patient Safety Rule, and for correcting deficiencies in a PSO's compliance; and the process by which a PSO can voluntarily relinquish its listing or, in the case of a PSO that does not correct one or more deficiencies, the process for delisting a PSO for cause. Within the framework established by the Patient Safety Act, PSOs are a source of expert advice for providers, and PSOs enable providers to take advantage of the potential for significant aggregation of patient safety Start Printed Page 48083events within the protections of the Patient Safety Act and Patient Safety Rule. As a result, healthcare providers, and those committed to improving the safety and quality of patient care, have a strong interest in the integrity of PSOs and their ability to carry out this statutory mission.

AHRQ administers the provisions of the Patient Safety Rule relating to listing and operation of PSOs, which are the focus of this guide. The HHS Office for Civil Rights is responsible for enforcing the confidentiality protections of the Patient Safety Act and Patient Safety Rule.

For an entity to be listed, and remain listed, as a PSO, the Patient Safety Rule relies primarily upon a system of attestations. An entity seeking listing for a three-year period as a PSO must submit to AHRQ a form, Certification for Initial Listing, to attest that it meets the Patient Safety Rule's eligibility and listing requirements at the time the entity submits its certifications. During its period of listing, a PSO must submit a form, Two Bona Fide Contract Requirement, every two years attesting that it has at least two contracts with different providers. If the PSO has other relationships, specified in section 3.102(d)(2), with any contracting provider, it must also submit the form, PSO Disclosure Statement, regarding its relationships with the provider and attest to the completeness and accuracy of its disclosures. Finally, a PSO must submit the form, Certification for Continued Listing, to seek continued listing for an additional three-year period and attest that it meets the requirements for continued listing. This process places the burden for understanding and complying with the Patient Safety Rule on the PSO.

The Patient Safety Rule also authorizes AHRQ to assess or verify PSO compliance with the rule's requirements at any time through requests for information or by conducting announced or unannounced reviews of, or site visits to, PSOs (section 3.110). In addition to routine compliance reviews, AHRQ may also conduct site visits or request additional information if, for example, AHRQ becomes aware that a PSO is not in compliance with the requirements of the statute or the Patient Safety Rule.

The Patient Safety Rule provides PSOs latitude in complying with its requirements. In part, this reflects a recognition that PSOs will vary in terms of size, complexity, and sophistication and, over time, PSOs will vary significantly in the breadth and scope of their activities. For example, PSOs can be local, regional, or national in orientation; they can focus narrowly or broadly in terms of the clinical or analytic services they offer providers; they can target their services toward one type of healthcare facility or multiple healthcare settings; and, they are likely to vary in the sophistication and complexity of information technology employed.

Each PSO will need to develop its approach to compliance by taking into account the specific mission it has chosen for itself, the specific activities and expertise it offers to healthcare providers, and its size and mode of operation. As a consequence, AHRQ developed this self-assessment guide recognizing that individual PSOs are likely to approach compliance from different perspectives. Thus, the guide does not propose a uniform approach to compliance, Instead, the guide presents sample questions—some of which may not be applicable or appropriate to a specific PSO—to encourage each PSO to take a comprehensive and systematic approach to compliance that best meets its circumstances.

The questions in the guide do not establish new standards or requirements; they are only presented for an illustrative purpose. If there is any inadvertent discrepancy between the text of the guide and the Patient Safety Rule, PSOs should consider the text of the rule as authoritative.

More information on the “Patient Safety Organizations: A Compliance Self Assessment Guide” and PSOs can be obtained through AHRQ's PSO Web site: http://www.pso.ahrq.qov/​index.html.

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Dated: September 11, 2009.

Carolyn M. Clancy,


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[FR Doc. E9-22594 Filed 9-18-09; 8:45 am]