[Federal Register Volume 80, Number 150 (Wednesday, August 5, 2015)]
[Notices]
[Pages 46585-46586]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-19114]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-15-15DA]
Agency Forms Undergoing Paperwork Reduction Act Review
The Centers for Disease Control and Prevention (CDC) has submitted
the following information collection request to the Office of
Management and Budget (OMB) for review and approval in accordance with
the Paperwork Reduction Act of 1995. The notice for the proposed
information collection is published to obtain comments from the public
and affected agencies.
Written comments and suggestions from the public and affected
agencies concerning the proposed collection of information are
encouraged. Your comments should address any of the following: (a)
Evaluate whether the proposed collection of information is necessary
for the proper performance of the functions of the agency, including
whether the information will have practical utility; (b) Evaluate the
accuracy of the agencies estimate of the burden of the proposed
collection of information, including the validity of the methodology
and assumptions used; (c) Enhance the quality, utility, and clarity of
the information to be collected; (d) Minimize the burden of the
collection of information on those who are to respond, including
through the use of appropriate automated, electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses; and
(e) Assess information collection costs.
To request additional information on the proposed project or to
obtain a copy of the information collection plan and instruments, call
(404) 639-7570 or send an email to [email protected]. Written comments and/or
suggestions regarding the items contained in this notice should be
directed to the Attention: CDC Desk Officer, Office of Management and
Budget, Washington, DC 20503 or by fax to (202) 395-5806. Written
comments should be received within 30 days of this notice.
Proposed Project
Improving the Impact of Laboratory Practice Guidelines (LPGs): A
New Paradigm for Metrics- American Society for Microbiology--NEW--
Center for Surveillance, Epidemiology and Laboratory Services (CSELS),
Centers for Disease Control and Prevention (CDC).
Background and Brief Description
The Centers for Disease Control and Prevention is funding three 5-
year projects collectively entitled ``Improving the Impact of
Laboratory Practice Guidelines: A New Paradigm for Metrics''. An
``LPG'' is defined as written recommendations for voluntary,
standardized approaches for medical laboratory testing that takes into
account processes for test selection, sample procurement and
processing, analytical methods, and results reporting for effective
diagnosis and management of disease and health conditions. LPGs may be
disseminated to, and used by, laboratorians and clinicians to assist
with test selection and test result interpretation. The overall purpose
of these cooperative agreements is to increase the effectiveness of
LPGs by defining measures and collecting information to inform better
LPG creation, revision, dissemination, promotion, uptake and impact on
clinical testing and public health.
The project will explore how these processes and their impediments
and facilitators differ among various intended users of LPGs. Through
this demonstration project, CDC seeks to understand how to customize
LPG creation and promotion to better serve these intended users of
LPGs. An important goal is to help organizations that sponsor the
development of LPGs create a sustainable approach for continuous
quality improvement to evaluate and improve an LPG's impact through
better collection of information.
The CDC selected three organizations that currently create and
disseminate LPGs to support activities under a cooperative agreement
funding mechanism to improve the impact of their LPGs. The American
Society for Microbiology (ASM), the Clinical and Laboratory Standards
Institute, and the College of American Pathologists, will each use
their LPGs as models to better understand how to improve uptake and
impact of these and future LPGs. Only the ASM submission will be
described in this notice.
The ASM project will address four LPGs that are important to
clinical testing and have a high public health impact: reducing blood
culture contamination (BCC), rapid diagnosis of blood stream infections
(BSI), proper collection and transport of urine (UT), and
microbiological practices to improve the diagnosis and management of
patients with Clostridium difficile (C. difficile) infection (CDI). The
BCC LPG was published and it includes recommendations for the use of:
1) venipuncture over catheters as the preferred technique for sample
collection in a clinical setting, and 2) phlebotomy teams over non-
phlebotomist staff for collecting blood for culture. The BSI report
examines the effectiveness of rapid diagnostic tests to promote more
accurate and timely administration of targeted antibiotic therapy for
patients with bloodstream infections. This report will be published and
recommendations will be developed based on additional information
collected. Practices related to the collection, storage and
preservation of urine for microbiological culture that improve the
diagnosis and management of patients with urinary tract infections were
analyzed and approved recommendations will be published.
Microbiological practices related to improving diagnosis and management
of patients with C. difficile infection will be collected and analyzed,
and recommendations will also be developed and published.
The intended respondents of ASM's surveys will include microbiology
supervisors, laboratory directors, laboratory managers, and medical
technologists. For this request for OMB approval of a new information
collection, we will be requesting approval to collect baseline and
post-dissemination information for the BCC LPG. Because the BSI, UT and
CDI reports are not yet published, ASM will conduct a baseline survey
to determine current practices prior to dissemination of the LPGs.
On behalf of the ASM and the CDC, the Laboratory Response Network
(LRN), which was founded by the CDC, will recruit laboratories that
perform the kinds of testing affected by these LPGs to take the
surveys. Messages regarding ASM surveys will be worded as an
invitation, not as a coercive request. Some states may opt not to
recruit LRN laboratory participation, but because the
[[Page 46586]]
issues are important to clinical and public health, we expect good
participation by most states. This mechanism will assure the best
response rate of all the options we considered.
The CDC LRN Coordinator will email a letter to the Laboratory
Director of the LRN Reference Laboratories, (i.e., 50 State Public
Health Laboratories, the New York City Public Health Laboratory and the
Los Angeles County Public Health Laboratory). These 52 LRN Reference
Laboratory Directors will be asked to then email the sentinel
laboratories, which include hospital and independent laboratories, in
their states, and provide a hyperlink to access the survey tool on-
line. SurveyMonkey[supreg] will host the online survey and be used as
the information collection instrument and responses will be collected
and maintained by ASM.
We anticipate that approximately 4,200 sentinel laboratories will
be contacted and asked to complete the survey on-line. ASM anticipates
achieving an 80% response rate with their information collections, or
3,360 out of approximately 4,200 aggregate responses for each of the
five different surveys.
In addition, the ASM will also recruit, by emailing a letter
containing the SurveyMonkey[supreg] hyperlinks for the five surveys to
each of their ClinMicroNet and DivCNet listervs inviting ~828 and ~1470
subscribers (comprised of laboratory directors as well as medical
technologists in a 99%:1% and 60%:40%), respectively, to take each of
the five SurveyMonkey[supreg] surveys. Moreover, the ASM will email the
same letter containing the SurveyMonkey[supreg] hyperlinks for the 5
surveys to ~1453 ASM Clinical Microbiology Issues Update newsletter
subscribers, which include microbiology supervisors, laboratory
directors, laboratory managers, and medical technologists in a 25
percent:25 percent: 25 percent: 25 percent ratio, to invite them to
participate.
For burden calculations, respondents will include microbiology
supervisors, laboratory directors, laboratory managers, and medical
technologists. According to ASM, the burden hours per respondent who
will be invited to participate in each of the BCC baseline and post-
dissemination surveys will not exceed 35 minutes and each of the BSI,
UT and CDI baseline surveys will be 20 minutes. This time frame was
specified based on ASM's previous experiences conducting laboratory
surveys. Each survey was pilot tested with 9 or fewer respondents
before dissemination.
The total estimated annualized burden hours for this collection is
17,225. There are no costs to respondents other than their time.
Estimated Annualized Burden Hours
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Average
Number of Number of burden per
Type of respondents Form name respondents responses per response (in
respondent hrs.)
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Microbiology Supervisors.............. BCC-baseline............ 2,463 1 35/60
BCC-post................ 2,463 1 35/60
BSI-baseline............ 2,463 1 20/60
UT-baseline............. 2,463 1 20/60
CDI-baseline............ 2,463 1 20/60
Laboratory Directors.................. BCC-baseline............ 3,115 1 35/60
BCC-post................ 3,115 1 20/60
BSI-baseline............ 3,115 1 20/60
UT-baseline............. 3,115 1 20/60
CDI-baseline............ 3,115 1 20/60
Laboratory Managers................... BCC-baseline............ 1,413 1 35/60
BCC-post................ 1,413 1 35/60
BSI-baseline............ 1,413 1 20/60
UT-baseline............. 1,413 1 20/60
CDI-baseline............ 1,413 1 20/60
Medical Technologists................. BCC-baseline............ 960 1 35/60
BCC-post................ 960 1 20/60
BSI-baseline............ 960 1 20/60
UT-baseline............. 960 1 20/60
CDI-baseline............ 960 1 20/60
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LeRoy A. Richardson,
Chief, Information Collection Review Office, Office of Scientific
Integrity, Office of the Associate Director for Science, Office of the
Director, Centers for Disease Control and Prevention.
[FR Doc. 2015-19114 Filed 8-4-15; 8:45 am]
BILLING CODE 4163-18-P