College of American Pathologists
Printable Version

  PAP/NGC Program Review


cap today

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

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.