[Federal Register Volume 79, Number 238 (Thursday, December 11, 2014)]
[Notices]
[Pages 73588-73589]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-29036]


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 DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-15-15GE]


Proposed Data Collections Submitted for Public Comment and 
Recommendations

    The Centers for Disease Control and Prevention (CDC), as part of 
its continuing effort to reduce public burden, invites the general 
public and other Federal agencies to take this opportunity to comment 
on proposed and/or continuing information collections, as required by 
the Paperwork Reduction Act of 1995. To request more information on the 
below proposed project or to obtain a copy of the information 
collection plan and instruments, call 404-639-7570 or send comments to 
Leroy A. Richardson, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or 
send an email to <a href="/cdn-cgi/l/email-protection#7e11131c3e1d1a1d50191108"><span class="__cf_email__" data-cfemail="ed82808fad8e898ec38a829b">[email protected]</span></a>.
    Comments submitted in response to this notice will be summarized 
and/or included in the request for Office of Management and Budget 
(OMB) approval. 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; (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; and (e) 
estimates of capital or start-up costs and costs of operation, 
maintenance, and purchase of services to provide information. Burden 
means the total time, effort, or financial resources expended by 
persons to generate, maintain, retain, disclose or provide information 
to or for a Federal agency. This includes the time needed to review 
instructions; to develop, acquire, install and utilize technology and 
systems for the purpose of collecting, validating and verifying 
information, processing and maintaining information, and disclosing and 
providing information; to train personnel and to be able to respond to 
a collection of information, to search data sources, to complete and 
review the collection of information; and to transmit or otherwise 
disclose the information. Written comments should be received within 60 
days of this notice.

Proposed Project

    Improving the Impact of Laboratory Practice Guidelines: A New 
Paradigm for Metrics--Clinical and Laboratory Standards Institute--
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, the Clinical and Laboratory Standards 
Institute (CLSI), 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 CLSI submission will be 
described in this notice.
    Specifically, the CLSI project will address two LPGs that are 
important to clinical testing and have a high public health impact: 
POCT12, Point-of-Care Blood Glucose Testing in Acute and Chronic Care 
Facilities and POCT13, Glucose Monitoring in Settings without 
Laboratory Support. These LPGs provide guidance and recommendations for 
personnel monitoring patient glucose levels at sites that have access 
to a hospital laboratory as well as locations, such as physician 
offices or nursing homes that do not have an on-site moderate or high 
complexity laboratory. It is expected that as a result of sustained 
improvements in the process of creating and updating these clinical 
LPGs, public health, which depends upon accurate and appropriate 
laboratory testing guided by the use of LPGs, will also generally 
benefit. The intended users of the CLSI's POCT12 and POCT13 LPGs will 
include point-of-care coordinators, clinical laboratory directors, 
medical technologists, nurses, and medical doctors.
    The CLSI plans to collect information using the same survey 
instrument, ``Fingerstick Glucose Survey'' (FGS), on three separate 
occasions. During the first information collection (FGS1), all targeted 
respondents will be asked to complete the survey. Respondents who 
indicate that they are not familiar with either POCT12 or POCT13 will 
be asked to provide an email address and offered a free copy of the 
applicable LPG. This subset of respondents will be asked to complete 
the same survey (FGS2) 4-6 months after receiving the free LPG. After 
analysis of the information collected during the first two surveys, 
CLSI will make improvements to POCT12 and POCT13, such as provision of 
educational materials or helpful products such as quality control logs, 
and may also alter their marketing campaigns to address issues related 
to awareness and use of CLSI documents.
    The third survey (FGS3) will then be sent to all targeted 
respondents approximately 2.5 years after the first survey to obtain 
information that can be used to evaluate the impact of these 
improvements. Respondents that received a free copy of POCT12 or POCT13 
following the first survey will also be contacted by email and asked to 
take the third survey.
    A link to the survey will be distributed to all targeted 
respondents either by email or postcard. The CLSI

[[Page 73589]]

will solicit participation from physician office laboratories, 
Department of Defense laboratories, and hospitals that offer point-of-
care glucose testing. Participants will be recruited by COLA, the Joint 
Commission and a Point-of-Care Coordinator network, who have agreed to 
distribute links to the survey through their membership mailing lists. 
In addition, participants will also be solicited through mailing lists 
purchased by CLSI from Clinscan and the American Hospital Association. 
Clinical sites offering point-of-care glucose testing in the Department 
of Defense medical system will also be asked to participate through the 
Department of Defense Clinical Laboratory Improvement Program (CLIP). 
In order to obtain the needed number of respondents for a statistically 
valid study, additional laboratories, selected at random from a 
database of Clinical Laboratory Improvement Amendment (CLIA) 
certificate holders, will also be solicited. The survey will contain 
instructions to direct it to the individual in each laboratory 
responsible for the development or revision of procedures for 
fingerstick glucose testing. Directing the survey to the individual 
with this specific responsibility will help to ensure that only one 
response will be obtained from each participating laboratory. 
Respondents include point-of-care coordinators, clinical laboratory 
directors, managers, and supervisors, medical technologists, nurses, 
and medical doctors.
    The CLSI hopes to achieve an 80% response rate with their 
laboratory information collections, or 24,000 out of about 30,000 
potential respondents. The second survey will occur approximately 4-6 
months after the initial survey and will only target responders from 
the first survey that received a complimentary copy of one of the LPG 
documents. CLSI anticipates that approximately 12,000 participants will 
be asked to take the second survey. Approximately two and a half years 
after the initial survey, the same survey will be sent to the same 
laboratories as the first survey (i.e. we will solicit approximately 
30,000 potential respondents and expect about 24,000 individuals to 
take the survey). The third survey will measure the impact of the 
modifications to the documents and marketing strategy made based on the 
data collected from the first 2 surveys. The response rate for all 
surveys will be maximized by repeated reminders using the same channel 
that will be used to distribute the survey. All targeted laboratories 
will receive an email or postcard approximately one month before 
distribution of the survey. This letter will describe the survey and 
our purpose for collecting information. Another email or post card with 
a link to the survey will be sent to the same targeted laboratories. We 
also plan to resend the link to the survey to all targeted laboratories 
approximately one month later to remind them of the survey.
    The CLSI believes completion of the survey will take approximately 
15 minutes. The survey will be pilot tested with 9 or fewer respondents 
before deployment to assure that they require 15 minutes or less to 
take.
    There are no costs to respondents other than their time.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                                     Number of       Number of      burden per     Total burden
      Type of respondent           Form name        respondents    responses per   response  (in       hours
                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
Point-of-Care Coordinators...  FGS1.............             500               1           15/60             125
                               FGS2.............             250               1           15/60              63
                               FGS3.............             500               1           15/60             125
Laboratory Directors.........  FGS1.............           4,276               1           15/60           1,069
                               FGS2.............           2,138               1           15/60             535
                               FGS3.............           4,276               1           15/60           1,069
Laboratory Managers..........  FGS1.............           4,276               1           15/60           1,069
                               FGS2.............           2,138               1           15/60             535
                               FGS3.............           4,276               1           15/60           1,069
Laboratory Supervisors.......  FGS1.............           4,276               1           15/60           1,069
                               FGS2.............           2,138               1           15/60             535
                               FGS3.............           4,276               1           15/60           1,069
Medical Technologists........  FGS1.............           7,800               1           15/60           1,950
                               FGS2.............           3,900               1           15/60             975
                               FGS3.............           7,800               1           15/60           1,950
Nurses.......................  FGS1.............           5,000               1           15/60           1,250
                               FGS2.............           2,500               1           15/60             625
                               FGS3.............           5,000               1           15/60           1,250
Medical Doctors..............  FGS1.............           3,500               1           15/60             875
                               FGS2.............           1,750               1           15/60             438
                               FGS3.............           3,500               1           15/60             875
                                                                                                 ---------------
    Total....................  .................  ..............  ..............  ..............          18,520
----------------------------------------------------------------------------------------------------------------


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. 2014-29036 Filed 12-10-14; 8:45 am]
BILLING CODE 4163-18-P


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