[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unpublished quality improvement studies/assessments carried out by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)
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Healthcare Organizations........................ 150 1 40/60 100
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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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