Epilogue. Establishment of the Center for Chronic Disease Prevention and Health Promotion.

The establishment of the Center for Chronic Disease Prevention and Health Promotion (CCDPHP) at the Centers for Disease Control (CDC) following the Conferences on the State of the Art in Quality Control Measures for Diagnostic Cytology Laboratories is briefly discussed. The CCDPHP is expected to play a major role in the CDC's cancer control program, including participation in establishing effective screening programs and assuring the quality of such methodologies as the Papanicolaou test and mammography.

Retrospective evaluation of gynecologic cytodiagnosis. II. Interlaboratory reproducibility as shown in rescreening large consecutive samples of reported cases.

Two laboratories exchanged and rescreened a large sample of cases with cervicovaginal smears they had consecutively accessioned to examine the reproducibility of gynecologic cytodiagnosis under optimum conditions. At least a "working agreement" (diagnoses within +/- 1 category on a ten-category scale) was achieved in diagnoses of normal, benign reaction and squamous abnormality (from minimal dysplasia though invasive cancer) in 18,859 cases (96.8%), of endometrial abnormality in 21 cases (42%) and of "unsatisfactory" in 99 cases (20.7%). Larger differences occurred in greater than or equal to 30% of cases except in the categories of "normal" and "benign reaction," reaching a maximum of 82% for moderate dysplasia. Reexamining 382 cases decreased disagreement by category to the 20% to 65% range only in the five categories of dysplasia plus carcinoma in situ. Agreement was not predicated on the presence of endocervical cells or squamous metaplasia; the basis for "unsatisfactory" calls was not uniform. Comparison of the laboratories' diagnoses with referee diagnoses or, on 178 cases, with tissue diagnoses also demonstrated differences in diagnostic criteria.

Measuring screening skills in gynecologic cytology. Results of voluntary self-assessment.

When the Clinical Laboratory Improvement Act (CLIA) was passed in 1967, the Centers for Disease Control (CDC) became interested in evaluating screening performance in cytodiagnosis. Finding no validated performance measurement methods that could be used on a national scale, the CDC initiated a program of sequential investigations to develop information that would describe the state of the art in microscopic performance in gynecologic cytopathology. The first of these experiments developed a method, the Self-Assessment Workshop, to measure performance at the microscope by using sets of glass slides. This paper describes the method, its validation process and participant performance over a 15-year period. Study results indicated that cytotechnologists and pathologists tended to correctly identify specimens (slides) in the negative and benign reaction categories in up to 95% of responses, but on slides of dysplasia they made 12% of their calls too low. Carcinomas in situ and invasive squamous cancers were undercalled in only about 5% of responses, but endometrial adenocarcinomas and other rare malignancies were undercalled in as much as 20%. The self-assessment technique is a practical, useful tool for identifying cytology personnel with serious deficiencies in cell location/identification skills and is well accepted by cytotechnologists and pathologists. However its limitations should be kept in mind: screening results from this simulated test should not be extrapolated to routine work performance; the screening time limit of five minutes per slide may adversely affect performance; and, finally, these results may reflect state-of-the-art performance only in voluntary, not mandatory, settings.

Retrospective evaluation of gynecologic cytodiagnosis. I. Reproducibility using an experimental diagnostic scale.

A system for the exchange of specimens between two independent laboratories ("A" and "B") was designed to enable them to review a consecutive series of one another's gynecologic smears. Another cytopathologist "refereed" diagnoses differing beyond agreed limits and examined all smears called carcinoma in situ or a more severe lesion by either laboratory. A ten-numeral gradient nomenclature scale was developed to code all cytodiagnoses for data processing. This analysis of the reproducibility of the experimental diagnostic system is based on all participants' examination of 100 selected specimens, half contributed by reviewing laboratory A and half by reviewing laboratory B, with the target value of each specimen established by the contributor. Intralaboratory reproducibility, expressed by a correlation coefficient (r), ranged from 0.78 to 0.93. After adjusting for straightforward squamous-cell lesions, r ranged from 0.88 to 0.91. Intralaboratory agreement +/- 1 scalar category, defined as a "working consensus," ranged from 77% to 84%. Interlaboratory correlation ranged from r = 0.74 to 0.94. Adjustment for squamous-cell lesions exerted less effect than it had on intralaboratory reproducibility. Interlaboratory agreement within one category ranged from 58% (laboratory B reviewing specimens contributed by laboratory A) to 92% (referee examining specimens contributed by laboratory B). Initially, laboratory A tended to classify a given specimen higher on the scale than did laboratory B and the referee, but as the study progressed, both laboratories tended to converge toward a more congruent diagnostic position, with referee greater than A greater than B. The level of discrimination attained by all participants validates use of this system to compare a larger series of diagnoses.