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What constitutes an adequate smear in fine‐needle aspiration cytology of the breast?

Cytopathologists experienced in breast fine-needle aspiration (FNA) are divided into two camps: those who use numeric cell counts as a criterion of adequacy and those who do not. The latter prefer to consider a specimen adequate if it answers the clinical question at hand, even if no cells are present. The commitment of this group to avoid cell counts reflects a number of factors, one of which is the clinical reality that approximately 50% of the patients with fibrocytic conditions have acellular aspirates, even when experienced examiners perform multiple biopsies. Based on this experience, we have never found cell counts useful, but remain willing to explore the issue. In the inaugural issue of Cancer Cytopathology, Layfield et al. reported their examination of 183 patients drawn from a pool of 1779 breast FNA cases studied from 1984 through 1995, looking for statistically valid criteria for adequacy in the FNA diagnosis of palpable breast nodules. The core of the study was a group of 21 patients with false-negative aspirations. The smears from each patient were reviewed and their cellularity scored as null, low, medium, or high based on the number of cell clusters and bare bipolar nuclei. The comparison groups were 75 true benign, 40 true malignant, and 47 atypical biopsies randomly selected from their total case experience. These additional cases also were reviewed and similarly scored for cellularity. Layfield et al. concluded that this study supported an optimal balance between the competing need to minimize both insufficiency rates and false-negative rates by establishing adequacy at 6 or more cell clusters (cumulative total of all slides) or the presence of 10 (or more) intact bipolar cells per 10 medium-power fields. As in his prior excellent study, Layfield sought to provide a potentially valuable quantitative dimension to the artful science of breast FNA. Although we applaud this effort, the study design made two choices regarding the exclusion of some data and the inclusion of other data that significantly and, we believe, adversely affected the study’s outcome and conclusions. When those choices are reviewed and, in our opinion, appropriately reversed, we find that smear cellularity is not in fact a meaningful measure of potential false-negativity. Therefore, it should not be used as a criterion for assessing sample adequacy. At the outset, the study design is highly biased against acellular smears by inexplicably dismissing 33% of all false-negative diagnoses (7 of 21) that resulted from interpretive error. No plaintiff ’s lawyer would be so quick or so kind as to forgive such a false-negative result just because it was interpretive in nature. One could almost argue as well that the study should exclude all cases with any cell content because that would eliminate conclusively all false-negative interpretative errors. The interpretive false-negative cases should be restored and the data reanalyzed.