[Federal Register Volume 78, Number 60 (Thursday, March 28, 2013)]
[Notices]
[Pages 18983-18985]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-07233]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-13-13OE]


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. 
To request more information on the proposed projects or to obtain a 
copy of the data collection plans and instruments, call 404-639-7570 or 
send comments to Ron Otten, 1600 Clifton Road, MS-D74, Atlanta, GA 
30333 or send an email 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 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 use of automated collection techniques or other 
forms of information technology. Written comments should be received 
within 60 days of this notice.

Proposed Project

    Cytology Workload Assessment and Measure--New--Office of 
Surveillance, Epidemiology and Laboratory (OSELS), Centers for Disease 
Control and Prevention (CDC).

Background and Brief Description

    CDC provides technical guidance to the Department of Health and 
Human Services (HHS) in coordination with the Centers for Medicare & 
Medicaid Services (CMS) and the Food and Drug Administration (FDA) for 
the implementation of the Clinical Laboratory Improvement Amendments 
(CLIA). The Clinical Laboratory Improvement Amendments of 1988 directed 
the Secretary of Health and Human Services to establish the maximum 
number of cytology slides that any individual may screen in a 24 hour 
period; to establish certain quality assurance standards; to set 
personnel standards; and to provide for periodic proficiency testing of 
cytotechnologists and pathologists involved in screening and 
interpreting cytological preparations. The regulations implementing 
CLIA, published in the Federal Register of February 28, 1992, 
established that the maximum number of slides examined by an individual 
in each 24 hour period was not to exceed 100 slides and could not be 
examined in less than an eight-hour day. The regulation further 
established that the technical supervisor is required to evaluate the 
performance of cytotechnologists at least every six months and 
determine their individual maximum daily workload limit. CDC requests 
OMB approval to collect information on cytology workload practice 
assessment through a survey on workflow and performance practices of 
cytotechnologists. Clearance is being requested for one year.
    In 1992, when the regulation was published, all Pap slides were 
conventional ``Pap smears.'' In a conventional Pap smear, samples are 
smeared directly onto a glass

[[Page 18984]]

microscope slide after collection. The cells are often obscured by 
blood or the smear may be too thick and contain contaminating 
artifacts. Today, almost all Pap tests in the U.S. are collected with a 
liquid-based method. Instead of ``smearing'' cervical cells directly 
onto a glass microscope slide, the cells are sent to the laboratory in 
a liquid preservative and processed by an automated processor. This 
processor disperses a uniform thickness representative sample on the 
slide that is free of obscuring blood, mucus, and non-diagnostic debris 
in a circle that covers less than one half of the slide.
    The Federal Advisory Committee for CLIA, the Clinical Laboratory 
Improvement Advisory Committee (CLIAC) has discussed cytology workload 
on numerous occasions from 1996 until present. The first workgroup was 
convened in July 1999 to provide input on how to determine workload for 
liquid-based Pap slides. The workgroup suggested it would be impossible 
to select one number that would be appropriate for all technology since 
automated and semi-automated screening devices were in development and 
approval by FDA might occur in the near future. In 2003, the CLIA 
requirements were amended to require the manufacturer of a semi-
automated screening device to include a maximum workload number in the 
product insert, rather than set a number in the CLIA regulations.
    The same year the amended regulations were made final, the first 
semi-automated device was approved which further reduced the area of 
screening by the cytotechnologist by using an automated review 
microscope to present the cytotechnologist with a set number of fields 
of view (FOV). This further complicated workload counting since it 
should take less time to review the FOVS than it would take to manually 
review the entire circle of the liquid-based preparation. Currently, 
two systems are FDA-approved, the Hologic ThinPrep[supreg] Imaging 
System and Becton Dickinson's Focal PointTM Guided Screening 
System. The product insert for both devices includes a method of 
counting slides where slides screened on the automated review 
microscope will be counted as half (0.5) and a full manual review of 
the entire circle will be counted as one (1) slide. CMS and FDA 
conducted an investigation into problems reported by surveyors of 
cytology laboratories regarding the two FDA-approved semi-automated 
screening devices. The investigation led to a different method for 
calculation of workload than the methods reported in the product 
inserts. This information was presented at the September 2010 CLIAC 
meeting and FDA issued an alert--How Laboratorians Can Safely Calculate 
Workload for FDA-Approved Semi-Automated Gynecologic Cytology Screening 
Devices. In this alert, it stated laboratories should have a clear 
standard operation procedure documenting the method of workload 
counting and explaining how the Technical Supervisor should establish 
workload limits for each individual. Also, the alert clarified how 
workload should be calculated when using either the Hologic's 
ThinPrep[supreg] Imaging System or Becton Dickinson's Focal 
PointTM Guided Screening System:
     All slides with full manual review (FMR) count as 1 slide 
(as mandated by CLIA's requirements for manual screening)
     All slides with only field of view (FOV) review count as 
0.5 or \1/2\ slide
     Then, slides with both FOV and FMR count as 1.5 or 1\1/2\ 
slides
     Use these values to count workload, which should not 
exceed the CLIA maximum limit of 100 slides in no less than an 8-hour 
day.
    On August 29, 2011 the American Society of Cytopathology's (ASC) 
Executive Board approved an ASC task force recommendation that the 
average laboratory cytotechnologist productivity should not exceed 70 
slides and that an individual's screening time should not exceed seven 
(7) hours in a 24 hour period. This recommendation was presented at the 
ASC 2011 annual meeting and was endorsed unanimously by the Cytology 
Education and Technology Consortium member organizations: American 
Society for Clinical Pathology, American Society for Cytotechnology, 
American Society of Cytopathology, and Papanicolaou Society of 
Cytopathology. The College of American Pathologists also acknowledged 
that the current workload limits for image assisted screening devices 
may be set too high for the average cytotechnologist, but that further 
study was needed to define best practices for semi-automated 
gynecologic workload limits.
    The ASC Taskforce recommendation was presented at the February 2012 
CLIAC meeting along with presentations describing workload studies and 
use of the workload limit as a target. The committee issued a 
recommendation that CLIAC supports the use of data from operational 
studies, such as those presented to CLIAC, to determine if the maximum 
workload limit using semi-automated screening instruments is 
appropriate and to discourage the use of regulatory maximum workload 
limits as productivity targets. CLIAC recommended that standardized 
criteria be developed for use in determining workload limits for each 
individual performing screening.
    Due to ongoing concerns regarding the appropriateness of the 
regulatory 100-slide maximum workload limit and lack of a standardized 
method for counting slides using the semi-automated screening devices, 
a study is needed to directly assess actual practice. The study needs 
to include a survey of laboratory practices related to setting 
individual workload limits. The survey will include questions regarding 
the maximum workload number of slides for each cytotechnologist 
employed in the cytology laboratory and how the slides are counted for 
workload purposes. Since the technical supervisor is required by CLIA 
to reevaluate the maximum workload number for each individual every six 
months and to determine policies for workflow and performance practices 
reporting this information, it is anticipated that the survey may be 
completed in 30 minutes.
     The results of this practice assessment will be used by DLSS/CDC 
to assist in the development of protocols for a time measurement study 
to determine the actual time spent screening slides. The results of 
this practice assessment and the time measure study may be used by HHS 
agencies responsible for CLIA to determine appropriate gynecologic 
screening workload maximums using semi-automated devices.
    Each laboratory will receive an advance request to participate in 
the survey from a DLSS contractor that has been selected to collect the 
survey data and conduct the time measure study. Respondents will be 
from the 1,245 cytology laboratories in the United States. Since a 
response to this survey is voluntary, we would expect an 80% response 
rate or approximately 996 laboratories. Responses would be submitted 
using an electronic web-based interface or in written format. The 
estimated burden per response is thirty minutes.
    CDC expects that information collection will begin in November 2013 
and end February 2014.
    There are no costs to respondents other than their time.

[[Page 18985]]



                                        Estimated Annualized Burden Hours
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                                                                      No. of        Avg. burden
      Type of respondents           Form name         No. of       responses per   per response    Total burden
                                                    respondents     respondent       (in hrs.)       (in hrs.)
----------------------------------------------------------------------------------------------------------------
Cytology laboratories.........  Cytology                     996               1           30/60             498
                                 Workload
                                 Assessment.
                               ---------------------------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............             498
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    Dated: March 21, 2013.
Ron A. Otten,
Director, Office of Scientific Integrity, Office of the Associate 
Director for Science, Office of the Director, Centers for Disease 
Control and Prevention.
[FR Doc. 2013-07233 Filed 3-27-13; 8:45 am]
BILLING CODE 4163-18-P