[Federal Register Volume 74, Number 181 (Monday, September 21, 2009)]
[Notices]
[Pages 48082-48083]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-22594]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Patient Safety Organizations: A Compliance Self-Assessment Guide

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

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

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SUMMARY: 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.

DATES: Availability of resource.

ADDRESSES: ``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.

FOR FURTHER INFORMATION CONTACT: 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: [email protected].

SUPPLEMENTARY INFORMATION:

Background

    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

[[Page 48083]]

events 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.

    Dated: September 11, 2009.
Carolyn M. Clancy,
Director.
[FR Doc. E9-22594 Filed 9-18-09; 8:45 am]
BILLING CODE 4160-90-M