PubMed · 8358142
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P R Wilson. 1993. Errors and artifacts.. https://pubmed.ncbi.nlm.nih.gov/8358142/
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The CLIA '88 regulations require the laboratory to review at least 10% of the gynecologic cases interpreted as negative that are examined by each cytotechnologist. The review must include negative cases selected at random and from patients identified as a high risk group. To evaluate the validity of this regulation, we reviewed the results of the 10% rescreen over a 24-mo period. The rescreening by pathologists detected epithelial abnormalities in 4/2,124 negative cases (0.18%). Subsequently, biopsy-proven squamous intraepithelial lesions were found in all four cases. Three different cytotechnologists were responsible for the four false-negative interpretations. Our results show that 10% rescreen of negative smears may detect a few false-negative cases. However, it is a time-consuming and inefficient mean to evaluate the performance of cytotechnologists. Quality control in gynecologic cytopathology is essential, but it is equally important that laboratories concentrate their resources and energy on methods proven to be effective.
The results of an internal quality assurance exercise in one cervical cytology laboratory in England are presented, using different types of partial percentage re-screening of cervical smears. An overall false negative dyskaryotic rate of up to 4.3% was demonstrated, with the final cytology report diagnosis differing from the primary screening dignosis in 1.3% of cases. These finding are discussed, with the aim of helping to foster debate on the setting of national laboratory internal quality assurance standards.