[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purpose of information collection is to include completed unpublished 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)
----------------------------------------------------------------------------------------------------------------
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