[Federal Register Volume 80, Number 38 (Thursday, February 26, 2015)]
[Notices]
[Pages 10489-10491]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-03985]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-15-15CK]
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- College of American Pathologists--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
[[Page 10490]]
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 CAP submission
will be described in this notice.
The CAP project will address two LPGs that are important to
clinical testing: immunohistochemistry test validation (IHC) and an
algorithm for diagnosing acute leukemia (ALA). The ALA LPG is being co-
developed with the American Society of Hematology (ASH). The intended
users of the CAP's IHC LPGs will include pathologists, clinical
laboratory directors, and laboratory managers overseeing the IHC
staining department. For the CAP's ALA LPG the intended users are
pathologists and hematologists overseeing testing for acute leukemia.
Thus, all these professionals will be surveyed by CAP.
Prior to entering into this cooperative agreement project with the
CDC, the CAP had already completed a baseline IHC LPG information
collection from laboratories that used IHC testing. Subsequent to this
information collection, the CAP created and disseminated an IHC LPG in
a peer reviewed journal. Because of this prior baseline assessment, the
CAP will only need to collect post-dissemination data. For their ALA
LPG CAP/ASH Algorithm for Initial Work-Up of Acute Leukemia, the CAP
will conduct both a baseline and a post-dissemination evaluation using
a survey and/or focus group. Because there are uncertainties concerning
the specific focus group probes for the IHC LPG and the ALA LPG, this
notice only provides a description of our collection of post-
dissemination information for the IHC LPG and the baseline ALA LPG.
The CAP hopes to achieve an 80% response rate, or 2668 out of 3335
potential respondents for the IHC LPG. This represents laboratories
known to be currently performing IHC testing based upon their
participation in CAP's IHC proficiency testing (PT) program and 450
additional laboratories identified by CDC using previous Centers for
Medicare and Medicaid Services Part B reimbursement claims for IHC
testing. The response rate for the baseline IHC survey was
approximately 70% and more focused promotion is planned. We have
identified a total of 3335 (2885 CAP-PT customers + 450 non-CAP-PT
customers) laboratories that will be targeted by the IHC post-
dissemination survey. Both populations represent laboratories that are
CAP-accredited and non-CAP-accredited.
Laboratories that are enrolled in CAP IHC PT programs will receive
surveys with their PT mailings. Non-CAP-PT-customer laboratories will
be surveyed via the US postal system, with a fax-back mechanism. Only
one response per laboratory will be accepted.
The CAP will need to collect both baseline and post-guideline
dissemination information for the ALA LPG. CAP will allow only one
response per computer internet protocol address. The CAP has a database
of pathologists who have indicated specialization in hematopathology;
these hematopathologists will be invited to participate. The CAP hopes
to achieve an 80% response rate with their individual information
collections, or 880 (80% x 1100 pathologists listed in the CAP
database).
The baseline survey for the ALA guideline includes questions about
individual practices for diagnosing various types of acute leukemia and
individual and laboratory reporting practices. The link to the baseline
survey for the ALA guideline will be disseminated via email to
hematopathologists in CAP's database. The online survey will be hosted
by Survey Monkey.
The CAP and CDC will strive to ensure a high response rate for
their IHC and ALA surveys. CAP plans to advertise both surveys.
Similarly, the CAP plans to maximize response rates for CAP-PT customer
laboratories by sending reminders through the PT program. The CAP will
also try to maximize response rates for the ALA survey by advertising
it through various channels and sending an email reminder.
For burden calculation, we assume one response per laboratory for
the IHC survey to include (1) pathologists, (2) laboratory directors,
and (3) other laboratory managers of IHC laboratories, which may
consist of graduate level scientists (Ph.D.s and Masters level),
approximately in a 25%:25%:50% distribution, respectively. We assume
respondents for the ALA surveys may include multiple responses within a
laboratory of pathologists and hematologists that sign out cases,
approximately in a 95%:5% distribution, respectively.
The IHC baseline survey, which was conducted prior to this CAP-CDC
cooperative agreement, took 15 minutes to complete. The IHC post-
dissemination survey is expected to take 20 minutes to complete. The
ALA baseline survey is expected to take an average of 25 minutes to
complete. The maximum times observed during pilot testing were 30 and
45 minutes, respectively. Results from the pilot tests were used to
revise both surveys.
The total Estimated Annualized Burden Hours for this ICR is 1,570.
There are no costs to respondents other than their time.
Estimated Annualized Burden Hours
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Avgerage
Number of Number of burden per
Type of respondents Form name respondents responses per response (in
respondent hrs.)
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Pathologists.......................... IHC..................... 834 1 20/60
ALA..................... 1,045 1 25/60
Laboratory Directors.................. IHC..................... 834 1 20/60
Laboratory Managers................... IHC..................... 1,667 1 20/60
Hematologists......................... ALA..................... 55 1 25/60
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[[Page 10491]]
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. 2015-03985 Filed 2-25-15; 8:45 am]
BILLING CODE 4163-18-P