Increasing cytotechnologist workload above 100 slides per day using the ThinPrep imaging system leads to significant reductions in screening accuracy.

BACKGROUND: With the current and projected shortage of a cytotechnologist (CT) workforce and the desire to reduce laboratory costs, increased productivity with automated assisted primary screening has become an attractive option for many laboratories. To the best of the authors' knowledge, longitudinal studies examining the effect of increasing workload on the performance of individual CTs have not been performed previously. METHODS: Using the ThinPrep imaging system (TIS), the performance of 3 CTs with variable levels of experience were evaluated. Their productivity was noted to increase from an average of 87 to 118 slides per day. The analysis included comparisons of error rates, screening rates, and screening times, including a review of 22 fields of view (FOV). Poststudy interviews of the CTs were also performed. RESULTS: Increased workload was found to be proportional to the decreased percentage of cases that underwent full manual review (25.2% to 20.1%; P < .001), and decreased actual screening times (7.3 hours/day to 6.7 hours/day, and 5.0 minutes/slide to 3.7 minutes/slide). This resulted in a lower detection of total abnormal findings (10.4% to 8.3%; P < .001), atypical squamous cells (6.7% to 4.9%; P < .001), and high-grade squamous intraepithelial lesion (0.9 %to 0.7%; P = .37), as well as an increased false-negative fraction rate (3.8% to 7.0%; P = .08). CONCLUSIONS: The results of the current study indicate that an increased average CT workload >100 slides per day with the TIS appears to have been accomplished mostly through a reduction in the amount of time spent reviewing the 22 FOV and the percentage of cases that underwent full manual review, which resulted in a significantly reduced screening performance.

Does the time of day or weekday affect screening accuracy? A pilot correlation study with cytotechnologist workload and abnormal rate detection using the ThinPrep Imaging System.

BACKGROUND: Workload is extensively regulated in gynecologic cytology. However, sensitive monitors of excessive workload are not available. METHODS: We measured the variation in abnormal (atypical squamous cells [ASC], low-grade squamous intraepithelial lesion [LSIL], and high-grade squamous intraepithelial lesion [HSIL]) rates for 4 cytotechnologists (CTs) among different days of the week and at different times during the day while they were performing primary screening with the ThinPrep Imaging System. RESULTS: Three of 4 CTs detected significantly less abnormal cases on 1 day of the week than another (1 Monday, 2 Friday). Two of those CTs detected significantly fewer total abnormal cases in the afternoon than in the morning; this was strongly correlated with increased speed in the afternoon and decreased detection of ASC cases. HPV + rates for ASC cases dropped as the abnormal rate dropped. The third CT detected significantly fewer ASC cases in the morning; this was counterbalanced by an increase detection of LSIL cases, suggesting a shift in diagnostic threshold between the AM and PM. The difference in abnormal detection rates between morning and afternoon correlated with a false-negative fraction of 0.96. CONCLUSIONS: There are significant differences in detection rates of abnormal cases between days of the week and the morning and afternoon. Correlating abnormal rates and workload between the morning and afternoon may represent a sensitive way to detect excessive workload. Because individual CTs may have different responses to workload and no overall pattern emerged, data on their workload and performance need to be tracked individually.

Reflex high-risk human papilloma virus DNA test is useful in the triage of women with atypical squamous cells cannot exclude high-grade squamous intraepithelial lesion.

This study is aimed to investigate the role of reflex high-risk human papilloma virus (HPV) DNA testing as an alternative triage method to colposcopy for women with atypical squamous cells cannot exclude high-grade squamous intraepithelial lesion (ASC-H) on Papanicolaou (Pap) tests. Reflex HPV DNA testing using Hybrid Capture II method was carried out on 88 women with ASC-H diagnosed by Thin Prep Pap test. Correlation with follow-up biopsies was available on 42 of these patients. The reflex HPV DNA test showed an overall positive rate of 67% and negative rate of 33% in 88 patients with ASC-H. Using age 30 as the cut off point, the positive rate had increased to 83.3% (35/42) in patients 30 yr or younger, while the positive rate for patients older than 30 yr had decreased to 52.2% (24/46). Follow-up colposcopic biopsy results were available in 35 of 59 HPV-positive women, which revealed 15 (43%) high-grade squamous intraepithelial lesions (HSIL), 12 low-grade squamous intraepithelial lesions (LSIL), and 8 negative for dysplasia. In 7 HPV-negative patients, the follow-up biopsies showed no evidence of HSIL or LSIL. Correlation between clinical risk factors and the HPV results demonstrated no significant differences in HPV positivity between the high-risk and low-risk patients. The high sensitivity (100%) and negative predictive rate (100%) in detecting HSIL in our study provide strong evidence that, instead of automatic referral to colposcopy, reflex HPV DNA testing may be used as an alternative triage method for women diagnosed with ASC-H on Thin Prep Pap test, especially for women older than 30 yr of age.

The significance of "low-grade squamous intraepithelial lesion, cannot exclude high-grade squamous intraepithelial lesion" as a distinct squamous abnormality category in Papanicolaou tests.

BACKGROUND: Early cytologic detection and treatment of high-grade squamous intraepithelial lesion (HSIL) is critical to cervical cancer prevention. The term atypical squamous cells (ASC), cannot exclude HSIL (ASC-H) was introduced in 2001 in the Bethesda System (TBS 2001) to define changes suggestive, but not diagnostic, of HSIL in the absence of unequivocal squamous intraepithelial lesion (SIL). Previous studies showed that women with ASC-H cytology are at an increased risk of harboring underlying histopathologic HSIL. TBS 2001, however, did not address the significance of finding ASC-H changes in a background of unequivocal low-grade SIL (LSIL). There may be a tendency for cytologists to lump these changes with either LSIL or HSIL, depending on their level of comfort. In their laboratory, the authors have referred to these changes as "LSIL, cannot exclude HSIL" (LSIL-H). METHODS: Between July 2001 and July 2003, all Papanicolaou (Pap) tests that were obtained by using the ThinPrep technique were retrieved from the computer data base at the authors' institution. All categories of squamous cell abnormalities, including LSIL-H, were evaluated for their incidence and follow-up diagnoses of HSIL and more severe lesions (HSIL +). All patients had a minimum of 2 year follow-up by biopsy and cytology (range, 2-4 years). RESULTS: LSIL-H comprised 0.15% (n = 194) of all Pap tests (n = 129,911) that were evaluated during the study period. Follow-up biopsy was available on 59 patients (30.4%), which showed HSIL + in 40.7% of patients. This rate of associated HSIL + differed significantly from that of LSIL (13%; P < .001) and HSIL (74%; P < .001), but was similar to that of ASC-H (44.6%). CONCLUSIONS: The results from this study showed that patients with cytologic diagnoses of LSIL-H had an intermediate risk of harboring histopathologic HSIL +. This risk was similar to ASC-H but fell between the low risk associated with ACS-US and LSIL and the high risk associated with HSIL cytologic diagnoses. The authors believe that LSIL-H should be considered as a distinct cytologic diagnostic interpretation and should be separated from LSIL and HSIL. Although LSIL-H does not represent a unique biologic entity, it has clinical usefulness because of its high positive predictive value for HSIL + lesions.

Comparison of ThinPrep and cytospin preparations in the evaluation of exfoliative cytology specimens.

BACKGROUND: There exists limited literature comparing ThinPrep (TP) with conventional cytospins (CS) in nongynecologic specimens. METHODS: The differences between TP and CS were evaluated for a variety of parameters including cellularity, cytologic morphology, specimen preparation, screening time, laboratory cost effectiveness, cytologist preference, and impact on final diagnosis. Eighty-eight cases including 38 urine, 13 respiratory, and 37 body fluids were prepared simultaneously. RESULTS: TP and CS demonstrated similar cellular yield in the majority of cases. Cytologists preferred TP in 63 (71.6%) and CS in 6 (6.8%) cases; whereas they indicated no preference in 19 (21.6%) cases. Of 14 abnormal cytologies, a more definitive diagnosis of malignancy was rendered by TP in 6 (42.9%) and by CS in 2 (14.3%) cases. TP demonstrated better nuclear chromatin morphology and more uniform distribution of cells. CS showed larger-sized clusters with better preservation of their architecture compared with smaller-sized clusters and significant shrinkage of cell size in TP. CONCLUSIONS: TP was preferred over CS in the majority of cases by both cytotechnologists and pathologists. Cellularity, screening time, and specimen preparation were comparable, although the latter was easier to standardize in TP. In abnormal cases, TP was found to be 3 times more helpful than CS in rendering a definitive diagnosis of malignancy. TP, however, was associated with certain artifacts that cytologists must become familiar with when examining such preparations. Although TP was superior to CS in most cases, the application of both methods may be helpful in selected cases in which the TP diagnosis is not conclusive. Finally, TP was found to be more cost effective than CS.