[Federal Register Volume 73, Number 199 (Tuesday, October 14, 2008)]
[Notices]
[Page 60705]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-24267]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality (AHRQ), Office for Civil 
Rights (OCR)


Implementing the Patient Safety and Quality Improvement Act of 
2005 Including How to Become a Patient Safety Organization: Interim 
Guidance Availability

October 14, 2008.
AGENCY: Agency for Healthcare Research and Quality (AHRQ), Office for 
Civil Rights (OCR), HHS.

ACTION: Notice of Availability.

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SUMMARY: AHRQ and OCR are announcing the availability of the guidance 
entitled ``Implementing the Patient Safety and Quality Improvement Act 
of 2005 Including How to Become a Patient Safety Organization.'' The 
Interim Guidance document explains how the Department of Health and 
Human Services (HHS) will begin implementing the Patient Safety and 
Quality Improvement Act of 2005 (Patient Safety Act), how an entity can 
become a Patient Safety Organization (PSO), and how information may be 
protected as Patient Safety Work Product (PSWP) in the interim period 
prior to the promulgation of a final regulation. To access the Interim 
Guidance, visit AHRQ's PSO Web site at http://www.pso.ahrq.gov.

DATES: The Interim Guidance is effective immediately with the 
publication of this notice. The Interim Guidance will remain effective 
until the effective date of the final regulation, which is expected to 
be promulgated before the end of 2008.

SUPPLEMENTARY INFORMATION: 

I. Background

    The Interim Guidance document is intended to inform private, public 
and nonprofit health care communities, the legal community and others 
of HHS's policies and procedures for implementing the Patient Safety 
Act, prior to the promulgation of a final regulation. This Interim 
Guidance interprets the Patient Safety Act. The Patient Safety Act 
(Pub. L. 109-41) amended the Public Health Service Act (42 U.S.C. 299 
et seq.) by renumbering existing sections and inserting new sections 
921 through 926 (42 U.S.C. 299b-21 through 299b-26). The Patient Safety 
Act authorizes the listing by the Secretary of statutorily defined 
PSOs. PSOs are to carry out statutorily defined patient safety 
activities on behalf of providers in order to assist them to improve 
patient safety. To encourage providers to submit information to PSOs 
and PSOs to conduct analyses regarding patient safety, the statute 
establishes privilege and confidentiality protections to protect 
certain information, including information collected by providers for 
sharing with PSOs for analysis, analyses performed by the providers 
and/or the PSOs, and information shared between the PSOs and the health 
care providers they serve. This information is defined in the statute 
as PSWP.

II. Significance of the Interim Guidance

    The Interim Guidance establishes the process by which the Secretary 
will list PSOs. Once PSOs are listed by the Secretary, providers can: 
(1) Voluntarily submit information to PSOs, and (2) seek PSOs' analysis 
of patient safety events. These activities should lead to improvements 
in patient safety. The protections established by the Patient Safety 
Act will permit and encourage numerous providers to submit pertinent 
data to PSOs so that the PSOs will be able to aggregate and analyze the 
data from multiple providers, thus enabling the identification of 
patterns that could suggest underlying or systemic causes of patient 
risks and hazards that then can be addressed to improve patient safety 
and quality.

III. Paperwork Reduction Act of 1995

    The listing of PSOs under the Interim Guidance involves collecting 
of information that is subject to review by the Office of Management 
and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 
3501-3520). These collections of information have been approved under 
OMB control number 0935-0143.

    Dated: October 7, 2008.
Ann C. Agnew,
Executive Secretary to the Department.
[FR Doc. E8-24267 Filed 10-8-08; 4:15 pm]
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