[Federal Register Volume 75, Number 51 (Wednesday, March 17, 2010)]
[Notices]
[Pages 12753-12754]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-5843]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30-Day-10-09CD]
Agency Forms Undergoing Paperwork Reduction Act Review
The Centers for Disease Control and Prevention (CDC) publishes a
list of information collection requests under review by the Office of
Management and Budget (OMB) in compliance with the Paperwork Reduction
Act (44 U.S.C. Chapter 35). To request a copy of these requests, call
the CDC Reports Clearance
[[Page 12754]]
Officer at (404) 639-5960 or send an e-mail to [email protected]. Send
written comments to CDC Desk Officer, Office of Management and Budget,
Washington, DC or by fax to (202) 395-5806. Written comments should be
received within 30 days of this notice.
Proposed Project
Laboratory Medicine Best Practices Project (LMBP)--New--National
Center for Emerging and Zoonotic Infectious Diseases (NCEZID)
(proposed), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
CDC is seeking approval from the Office of Management and Budget
(OMB) to collect information from healthcare organizations in order to
conduct a systemic review of laboratory practice effectiveness. The
purpose of information collection is to include completed unpublished
quality improvement studies/assessments carried out by healthcare
organizations (laboratories, hospitals, clinics) in systematic reviews
of practice effectiveness. CDC has been sponsoring the Laboratory
Medicine Best Practices (LMBP) initiative to develop new systematic
evidence reviews methods for making evidence-based recommendations in
laboratory medicine. This initiative supports the CDC's mission of
improving laboratory practices.
The focus of the Initiative is on pre- and post-analytic laboratory
medicine practices that are effective at improving health care quality.
While evidence-based approaches for decisionmaking have become standard
in healthcare, this has been limited in laboratory medicine. No single-
evidence-based model for recommending practices in laboratory medicine
exists, although the number of laboratories operating in the United
States and the volume of laboratory tests available certainly warrant
such a model.
The Laboratory Medicine Best Practices Initiative began in October
2006, when Division of Laboratory Systems (DLS) convened the Laboratory
Medicine Best Practices Workgroup (Workgroup), a multidisciplinary
panel of experts in several fields including laboratory medicine,
clinical medicine, health services research, and health care
performance measurement. The Workgroup has been supported by staff at
CDC and the Battelle Memorial Institute under contract to CDC.
To date, the Laboratory Medicine Best Practices (LMBP) project work
has been completed over three phases. During Phase 1 (October 2006-
September 2007) of the project, CDC staff developed systematic review
methods for conducting paper reviews related to the effectiveness of
laboratory medicine practices. Results of a review of practices that
reduce patient specimen identification indicated that an insufficient
quality and number of published studies were available for completing
systematic evidence reviews of laboratory medicine practice
effectiveness for multiple practices. These results were considered
likely to be generalizable to most potential review topics of interest.
A finding from Phase 1 work was that laboratories would be unlikely to
publish quality improvement projects or studies demonstrating practice
effectiveness in the peer reviewed literature, but that they routinely
conducted quality improvement projects and had relevant data for
completion of evidence reviews. Phase 2 (September 2007-November 2008)
and Phase 3 (December 2008-September 2009), involved further
development of methods to obtain and critically appraise published and
unpublished data. A pilot test of a standardized data collection form
with less than nine potential laboratory respondents supported the
Phase 1 finding that data from completed laboratory medicine quality
improvement projects could supplement published evidence in systematic
reviews. The objective for successive LMBP evidence reviews of practice
effectiveness is to supplement the published evidence with unpublished
evidence to fill in gaps in the literature.
Healthcare organizations and facilities (laboratories, hospitals,
clinics) will have the opportunity to voluntarily enroll in an LMBP
network and submit readily available unpublished studies; quality
improvement projects, evaluations, assessments, and other analyses
relying on unlinked, anonymous data using the LMBP Submission Form.
LMBP Network participants will also be able to submit unpublished
studies/data for evidence reviews on an annual basis using this form.
There will be no charge to respondents for their participation, other
than their time. The total estimated annualized burden hours for this
information collection request are 138 hours.
Estimated Annualized Burden Hours
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Number of Average burden
Respondents Number of responses per per response
respondents respondent (in hours)
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Healthcare Organizations..................................... 150 1 55/60
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Date: March 11, 2010.
Maryam I. Daneschvar,
Acting Reports Clearance Officer, Centers for Disease Control and
Prevention.
[FR Doc. 2010-5843 Filed 3-16-10; 8:45 am]
BILLING CODE 4163-18-P