80 FR 35360 - Agency Forms Undergoing Paperwork Reduction Act Review

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 80, Issue 118 (June 19, 2015)

[Federal Register Volume 80, Number 118 (Friday, June 19, 2015)]
[Notices]
[Pages 35360-35362]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-15128]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-15-15GE]


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: 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 (CDC) 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 (CLSI), and the College of American Pathologists (CAP), 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 and at locations, such as physician offices or 
nursing

[[Page 35361]]

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 2 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 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 postcard with 
a link to the survey will then 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 
complete.
    The total estimated annualized burden is 6,173 hours. This is 
calculated by dividing the total burden hours by the number of years 
(three) over which data is collected. The maximum burden is 7,407 hours 
that occurs in years 1 and 3.
    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 respondent             Form name      respondents    responses per   response  (in
                                                                      respondent        hours)
--------------------------------------------------------------------------------------------------
Point-of-Care Coordinators........            FGS1             500               1           15/60
                                              FGS2             250               1           15/60
                                              FGS3             500               1           15/60
Laboratory Directors..............            FGS1           4,276               1           15/60
                                              FGS2           2,138               1           15/60
                                              FGS3           4,276               1           15/60
Laboratory Managers...............            FGS1           4,276               1           15/60
                                              FGS2           2,138               1           15/60
                                              FGS3           4,276               1           15/60
Laboratory Supervisors............            FGS1           4,276               1           15/60
                                              FGS2           2,138               1           15/60
                                              FGS3           4,276               1           15/60
Medical Technologists.............            FGS1           7,800               1           15/60
                                              FGS2           3,900               1           15/60
                                              FGS3           7,800               1           15/60

[[Page 35362]]

 
Nurses............................            FGS1           5,000               1           15/60
                                              FGS2           2,500               1           15/60
                                              FGS3           5,000               1           15/60
Medical Doctors...................            FGS1           3,500               1           15/60
                                              FGS2           1,750               1           15/60
                                              FGS3           3,500               1           15/60
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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. 2015-15128 Filed 6-18-15; 8:45 am]
 BILLING CODE 4163-18-P