[Federal Register Volume 78, Number 28 (Monday, February 11, 2013)]
[Notices]
[Pages 9698-9699]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-02984]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30-Day-13-0848]
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 Officer at (404) 639-7570 or send an email to
[email protected]. Send written comments to CDC Desk Officer, Office of
Management and Budget, Washington, DC or by fax to (202) 395-6974.
Written comments should be received within 30 days of this notice.
Proposed Project
Laboratory Medicine Best Practices Project (LMBP) (0920-0848, exp.
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 a systematic 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purpose of information collection is to include completed unpublished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 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 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 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 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
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. The
total estimated annualized burden hours for this information collection
request are 100 hours.
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Respondents Number of responses per per response
respondents respondent (in hours)
----------------------------------------------------------------------------------------------------------------
Healthcare Organizations..................................... 150 1 40/60
----------------------------------------------------------------------------------------------------------------
[[Page 9699]]
Dated: February 5, 2013.
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. 2013-02984 Filed 2-8-13; 8:45 am]
BILLING CODE 4163-18-P