[Federal Register Volume 77, Number 233 (Tuesday, December 4, 2012)]
[Notices]
[Pages 71796-71797]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-29176]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60 Day-13-0848]


Proposed Data Collections Submitted for Public Comment and 
Recommendations

    In compliance with the requirement of Section 3506(c)(2)(A) of the 
Paperwork Reduction Act of 1995 for opportunity for public comment on 
proposed data collection projects, the Centers for Disease Control and 
Prevention (CDC) will publish periodic summaries of proposed projects. 
To request more information on the proposed projects or to obtain a 
copy of the data collection plans and instruments, call 404-639-7570 
and send comments to Ron Otten, 1600 Clifton Road, MS-D74, Atlanta, GA 
30333 or send an email to [email protected].
    Comments are invited on: (a) Whether the proposed collection of 
information is necessary for the proper performance of the functions of 
the agency, including whether the information shall have practical 
utility; (b) the accuracy of the agency's estimate of the burden of the 
proposed collection of information; (c) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (d) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques or other 
forms of information technology. Written comments should be received 
within 60 days of this notice.

Proposed Project

    Laboratory Medicine Best Practices Project (LMBP), OMB Control 
Number 0920-0848, Expiration 5/31/2013--EXTENSION--Office of 
Surveillance, Epidemiology and Laboratory Services (OSELS), 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 systemic evidence reviews 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unpublished quality improvement studies/assessments carried out by 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 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 decision-making 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 CDC 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 evidence reviews 
using published literature, and completed a proof-of-concept test. 
Results of an extensive search and review of published literature using 
the methods for the topic of patient specimen identification indicated 
that an insufficient quality and number of studies were available for 
completing systematic evidence reviews of laboratory medicine practice 
effectiveness for multiple practices, and hence for making evidence-
based recommendations. These results were considered likely to be 
generalizable to most potential topic areas 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

[[Page 71797]]

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 methods 
development and pilot tests to obtain, review, and evaluate published 
and unpublished evidence for practices associated with the topics of 
patient specimen identification, communicating critical value test 
results, and blood culture contamination. Exploratory work by CDC 
supports the existence of relevant unpublished studies or completed 
quality improvement projects related to laboratory medicine practices 
from healthcare organizations. 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 (laboratory, 
hospital, clinic) will have the opportunity to voluntarily enroll in an 
LMBP registrant 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 registrants will also be able to submit 
unpublished studies/data for evidence reviews on an annual basis using 
this form. There is no cost to respondents other than their time.

                                        Estimated Annualized Burden Hours
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                                                                                      Average
                                                      No. of          No. of        burden per     Total burden
                   Respondents                      respondents    responses per   response  (in   (in hours) *
                                                                    respondent         hrs)
----------------------------------------------------------------------------------------------------------------
Healthcare Organizations........................             150               1           40/60             100
                                                 ---------------------------------------------------------------
    Total.......................................  ..............  ..............  ..............             100
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    Dated: November 26, 2012.
Ron A. Otten,
Director, Office of Scientific Integrity (OSI), Office of the Associate 
Director for Science (OADS), Office of the Director, Centers for 
Disease Control and Prevention.
[FR Doc. 2012-29176 Filed 12-3-12; 8:45 am]
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