An effective quality control program for the cytology laboratory.
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Biomedical subjects
Publications and source records attributed to W M Hindman.
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A system of quality control for gynecologic cytologic screening designed to minimize the problem of false-negative cytologic reports is proposed. The system involves the harvesting of "quality control" smears, at the time of colposcopic examination, from patients referred to colposcopy because of previous abnormal smears that had been interpreted as representing dysplasia or neoplasia. These quality control smears are then submitted to the cytology laboratory, indistinguishable from bona fide cases, among the routine smears. This appears to be a more effective means of quality control than the current standard system used in the United States, which involves cytology laboratories routinely rescreening 10% of the slides reported out as "negative".
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The cytologic accuracy, sources of error and value of duplicate samples were studied in 87 women simultaneously biopsied for cervical intraepithelial neoplasia. Separately evaluated by two laboratories, correlation with biopsy was 70% for the first cytology and 67% for the second. Discrepant cytologies were reciprocally reviewed in error analysis. The sources of error were cytologic sampling (10.9%), evaluation (5.8%) and both (4.0%). Attention is directed to the high proportion of cases (15%) in which sampling error was a factor; awareness of this observation is necessary in patient management. The duplicate second cytology was of substantial value in 7% of the cases and helpful in an additional 3.5%; both figures are lower than in recent reports. If errors in evaluation or evaluation sampling are held to a 10% level, routine duplicate studies may not be justified.