[Federal Register Volume 74, Number 138 (Tuesday, July 21, 2009)]
[Notices]
[Pages 35870-35871]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-17266]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60 Day-09-09CD]


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. 
Alternatively, to obtain a copy of the data collection plans and 
instrument, call 404-639-5960 and send comments to Maryam I. Daneshvar, 
CDC Reports Clearance Officer, 1600 Clifton Road, NE., MS-D74, Atlanta, 
Georgia 30333; comments may also be sent by e-mail 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 a 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

[[Page 35871]]

use of information technology. Written comments should be received 
within 60 days of this notice.

Proposed Project

    Laboratory Medicine Best Practices Project (LMBP)--New--National 
Center for Preparedness, Detection, and Control of Infectious Diseases 
(NCPDCID), 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purpose of information collection is to include completed unpublished 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 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 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 is no cost to respondents other than their time.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of
                   Respondents                       Number of     responses per  Average burden   Total burden
                                                    respondents     respondent      (in hours)      (in hours)
----------------------------------------------------------------------------------------------------------------
Healthcare Organizations........................             150               1           40/60             100
                                                 ---------------------------------------------------------------
    Total.......................................  ..............  ..............  ..............             100
----------------------------------------------------------------------------------------------------------------


    Dated: July 15, 2009.
Marilyn S. Radke,
Reports Clearance Officer, Centers for Disease Control and Prevention.
[FR Doc. E9-17266 Filed 7-20-09; 8:45 am]
BILLING CODE 4163-18-P