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August 2003
Special Section
The cytopathology component of
the new CLIA modifications
How to donate
Margaret H. Neal, MD
The new CLIA modifications published Jan. 24 attempt to simplify the requirements while maintaining
the goal of patient safety. The new publication includes several changes in
the cytology regulations that are summarized here and will be reflected in
the next version of the CAP Laboratory Accreditation Program checklist.
* For workload limit calculations,
liquid-based Paps count as whole slides. Previous regulations allowed all
liquid-based preparations that result in cell dispersion over one-half or
less of the slide area to be counted as one-half slides. The new version allows
only nongynecologic liquid-based preparations to be counted as one-half slides.
The CAP Cytopathology Committee has always recommended counting all liquid-based
Paps as whole slides (in a note in the cytopathology checklist) because of
the care that is necessary to adequately screen these preparations and to
accurately interpret cellular changes, which are sometimes subtle and scant.
* For gynecologic cytology/histology
correlations, CLIA now requires gynecologic reports with a diagnosis of HSIL,
adenocarcinoma, or other malignant neoplasms to be compared with available
clinical information and with the histopathology report, if available in the
laboratory. The previous regulation required correlations for all malignant
and premalignant lesions (not only high-grade lesions but also low-grade squamous
intraepithelial lesions).
* The new regulations provide
more explicit instructions for assessing individual cytotechnologist workload
limits. The evaluation should be based on (1) a reevaluation of 10 percent
of the cases interpreted to be negative by cytotechnologists, and (2) a comparison
of the cytotechnologist's interpretation with the final diagnosis on cases
of ASC-US, LSIL, HSIL, glandular epithelial abnormalities, or other malignant
neoplasms.
* Laboratories are now required
to document the number of cases in which abnormal Paps have histology correlation.
This requirement is the opposite of the prior regulation, which required documentation
of the number of cases in which histology reports were unavailable for comparison
with abnormal Pap results. The new requirement may help determine a laboratory's
success in obtaining histology reports for correlation.
* The regulations state
that cytology slides may be loaned to proficiency testing programs in lieu
of retaining them on site as long as the slides are acknowledged by the proficiency
testing provider and retrievable upon request. (So please donate slides to
the CAP Pap program!)
* The new regulations state
that when using automated and semiautomated screening devices, the laboratory
must follow the manufacturer's instructions for preanalytic, analytic, and
postanalytic phases of testing as applicable, and meet the applicable requirements
of Quality Systems for Nonwaived Testing (subpart K).
These are the major changes that involve cytopathology. The complete Federal Register update
is available at www.phppo.cdc.gov/clia/pdf/CMS-2226-F.pdf.
Reference Medicare, Medicaid, and CLIA programs; laboratory requirements relating to quality systems
and certain personnel qualifications. Final rule. Federal Register. 2003 Jan. 24;68(16):3639-3714.
Dr. Neal, a member of the CAPCytopathology Committee, is with KWB Pathology Associates, Tallahassee, Fla.
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