[Federal Register Volume 78, Number 175 (Tuesday, September 10, 2013)]
[Notices]
[Pages 55258-55259]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-21911]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30-Day-13-13OE]
Agency Forms Undergoing Paperwork Reduction Act Review
The Centers for Disease Control and Prevention (CDC) publishes a
list of information collection requests under review by the Office of
Management and Budget (OMB) in compliance with the Paperwork Reduction
Act (44 U.S.C. Chapter 35). To request a copy of these requests, call
(404) 639-7570 or send an email to [email protected]. Send written comments
to 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
Image-Assisted Cytology Workload Assessment and Measure--New--
Office of Surveillance, Epidemiology, and Laboratory Services (OSELS),
Centers for Disease Control and Prevention (CDC).
[[Page 55259]]
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 (CLIA)
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. 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 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.
CLIA's Federal Advisory Committee, the Clinical Laboratory
Improvement Advisory Committee (CLIAC), has discussed cytology workload
on numerous occasions from 1996 until present. 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.
Each laboratory will receive an advance request to participate in
the Image-Assisted Cytology Workload Practices Survey from a DLSS
contractor that has been selected to collect the survey data and
conduct the time measure study. Respondents will be cytology
supervisors from the 1,245 cytology laboratories in the Unites States.
Since a response to this survey is voluntary we would expect an 80%
response rate or approximately 996 laboratories. Responses would be
submitted in written format. The estimated burden per response is one
half hour. In addition, individual cytotechnologists working in the
laboratory will be asked to complete the Image-Assisted Cytology
Workload Assessment Survey. There are 6,064 cytotechnologists in the
United States. Response to this survey is voluntary, so we would expect
an 80% response rate or approximately 4,581 cytotechnologists.
Responses would be submitted in written format. The estimated burden
per response is one half hour. CDC requests OMB approval to collect
information for one year.
There are no costs to respondents other than their time.
The total estimated annual burden hours are 2,789.
Estimated Annualized Burden Hours
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Number of Average burden
Type of respondents Form name Number of responses per per response
respondents respondent (in hrs.)
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Cytology Supervisor................... Image-Assisted Cytology 996 1 30/60
Workload Practices.
Cytotechnologists..................... Image-Assisted Cytology 4,581 1 30/60
Workload Assessment.
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Leroy 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. 2013-21911 Filed 9-9-13; 8:45 am]
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