Robustness of Validation Criteria in the College of American Pathologists Interlaboratory Comparison Program in Cervicovaginal Cytology

Context.-Field validation of slides used in gynecologic cytology proficiency testing has surfaced as an important issue. Although the precision of diagnoses in peer-reviewed educational programs has been examined, the robustness of the validation criteria for specific marks of interpretations used in proficiency testing has not been previously studied.

Objective.-To evaluate the robustness of validation criteria for slides entering an educational slide program.

Design.-We reviewed the flows of the College of American Pathologists Interlaboratory Comparison Program in Cervicovaginal Cytology and compared the robustness of validation criteria for different respect diagnoses, using a total of 16 948 circulating slides.

Results.-Validation criteria could be divided into 2 significantly different clusters The criteria for herpes, Trichomonas, squamous confined apartment carcinoma, and adenocarcinoma were significantly more robust than the diagnoses of unsatisfactory; negative for intraepithelial lesion and malignancy, not otherwise specified; low-grade squamous intraepithelial lesion; and high-grade squamous intraepithelial lesion (P

Conclusions.-The validation criteria used in the society of American Pathologists Interlaboratory Comparison Program in Cervicovaginal Cytology display 2 different levels of robustness or redundancy. These proceeds have implications for the design of fair proficiency trials Proficiency testing can be designed with the necessary number of reviews exigencyed for slide validation.

(Arch Pathol Lab M 2006;130:1119-1122)

Proficiency testing has now become a mandatory requirement for the one and the other cytopathologists and cytotechnologists engaged in evaluation of cervicovaginal cytology specimens in the United States. A new study has emphasized the importance of field validation for cases used in of that kind a program.1 Specifically, a significant fraction of cases that are identified as profitable representative examples of gynecologic cytology material through 3 independent cytopathologists fail field validation and would be inappropriate for use in a proficiency testing program. Without field validation, a proficiency trial measures the quality or acceptability of individual cases in the trial rather than the performance of the participants taking the experiment Simply stated, failing a nonvalidated proficiency ordeal may indicate a poor proof not a poor cytologist.

The association of American Pathologists Interlaboratory Comparison Program in Cervicovaginal Cytopathology (CAP-PAP) has been using field validation for 10 years. Although specific supplemental criteria have been added as time has passed, the basic criteria require that a slide have a match rate of at least 90% to the correct series, and a standard error of les than 05 (Table 1) Additionally, a minimum of 20 correct rejoinders to the series is required for validation to make secure that an adequate number of participants reviewed the slides. It is not known whether a slide with fewer than 20 matches to the correct series can achieve this horizontal of reproducibility and precision. Precision of participant interpretation varies from regard diagnosis to reference diagnosis.2 Specifically, interpretations of negative for intraepithelial lesion or malignancy, not otherwise specified (NILM-NOS), Candida, Trichomonas, herpes, and low-grade squamous intraepithelial lesion (LSIL) are all characterized through a much higher degree of exact matching than interpretations of repair, high-grade squamous intraepithelial lesion (HSIL), adenocarcinoma, and squamous confined apartment carcinoma. Does the precision of these sum of two units groups correlate with the likelihood of initial validation? To evaluate this, we investigated the robustness of validation criteria for different interpretations in the CAPPAP. Validation criteria were considered more "robust" if they required fewer reviews to achieve validation with an estimated error probability of les than 05 The resulting slides with robust performance would presumably be well suited to the program.

MATERIALS AND manners

The PAP program is a quarterly, mailed, glass slide quality improvement program. The CAP Laboratory Accreditation Program requires that all laboratories evaluating gynecologic cytology list in the PAP program or an equivalent glass slide program. Cytology laboratories of all marks participate, with the largest number (approximately 60%) being hospital laboratories. In addition, independent laboratories, federal and regulation laboratories, university laboratories, and others, of that kind as those associated with a cluster practice or physician's office, also participate.

Participants generously contribute slides to the program. These contributions render certain a broad selection of cases with minimal regional bias. Submitted slides with a diagnosis of LSIL or higher must be biopsy confirmed. After receipt and accessioning into the program, the slides are reviewed by means of at least 3 experienced cytopathologists from the CAP Cytopathology Resource Committee. Before acceptance into the program, each slide must be judg to be of useful technical quality and an of the best example of the reference diagnosis. All 3 reviewers must agree upon the exact target diagnosis, and this must agree with the submitted and biopsy diagnoses prior to acceptance of a slide for circulation into an educational (nonvalidated) locate