Telecytology validation: is there a recipe for everybody?

INTRODUCTION: Telecytology offers a suitable solution to the cost and time efficiency questions on rapid onsite evaluation (ROSE). An increasing number of institutions are adopting new telecytology systems to meet the increasing ROSE requests, although there is no agreement on the details of how a telecytology validation study needs to be conducted. We propose a standardized approach for telecytology validation studies that could be done in a variety of practices. MATERIALS AND METHODS: Consecutive cases from 6 months prior were chosen to reflect a case mix comparable to real life. A fellow assessed the slides at the ROSE site while 6 cytopathology faculty convened in a conference room with a television screen, and noted the adequacy, diagnostic category, and specific diagnoses. All participants were blinded to the original adequacy assessment and final diagnoses. For each case, evaluation time and the slides counts were noted. RESULTS: Fine-needle aspiration specimens from 52 patients were included in the study. Of these, 13 cases were used in the first "test" session. The adequacy concordance rates ranged between 92.3% and 100%, with an overall concordance rate of 94.8%. The diagnostic category concordance rates ranged between 90.3% and 95.5%, with an overall concordance rate of 91.9%. The specific diagnosis concordance rates ranged between 84.6% and 92.9%, with an overall concordance rate of 88.1%. CONCLUSIONS: Validation of telecytology requires a standardized approach just like any other new technology. In this study, we propose an efficient and accurate method for cytopathology departments of various case volumes to conduct telecytology validation studies.

Five-year retrospective review in gynecologic cytopathology: is it time to amend?

INTRODUCTION: According to the Clinical Laboratory Improvement Amendments 1988 regulations, 5-year retrospective review (5YRR) of normal Papanicolaou tests in patients with a newly diagnosed high grade squamous intraepithelial lesion or above (HSIL+) is mandatory. Since this mandate has been in place, a multitude of changes have taken place in the screening and management guidelines of cervical cancer. The aim of this study is to assess the role of this mandate in our laboratory and to investigate the lessons learned. MATERIAL AND METHODS: The cytopathology electronic database and institutional quality assurance records at Loyola University Medical Center were searched from January 2009 to December 2019 to identify all Papanicolaou tests diagnosed as new "HSIL and above" (HSIL+). Major discrepancy (2+) was defined as initial negative diagnosis changed to HSIL+. RESULTS: A total of 153,083 Papanicolaou tests were performed during this period; out of these, 1452 (0.94%) were diagnosed as HSIL+. A total of 695 HSIL+ Papanicolaou tests had a negative prior Papanicolaou and in 615 of 695 there was agreement with the initial negative diagnosis. In 61 Papanicolaou tests, the initial diagnosis was changed from negative and they were reclassified on review as 3 HSIL, 9 ASC-H, 7 AGC, and 42 ASCUS or LSIL. Major discrepancy rate was calculated as 3 of 695 (0.43%). None required an amended report. CONCLUSIONS: It is important to revisit the 5YRR as a method of implementing the quality indicators in gynecologic cytology so that the process retains its value without overburdening cytology laboratories and personnel.

Outcome analysis and negative predictive value of the "unsatisfactory/nondiagnostic" category of The Paris System for Reporting Urinary Cytology.

INTRODUCTION: The Paris System (TPS) for Reporting Urinary Cytology (UCyto) was published in 2016, but to date, no study addressing the unsatisfactory (UNSAT) category has been published. We aimed to identify the negative predictive value (NPV) for UNSAT UCyto after the implementation of TPS at our institution. METHOD: For the period from January 1, 2017, to December 31, 2019, we identified all cases with UNSAT diagnosis on UCyto specimens and available cytologic and/or surgical pathology follow-up within 6 months from the UNSAT diagnosis. Cases were deemed true negative (TN) if the follow-up was "negative for high-grade urothelial carcinoma" (NHGUC). Information regarding previous medical history, clinical indications, and specimen type were tabulated and analyzed. RESULTS: From 6348 UCyto specimens, there were 230 (3.6%) UNSAT diagnoses made on 209 patients (112 [53.6%] men and 97 [46.4%] women) with a median age of 64 years. Of these, 116 UCyto specimens from 106 patients, which had cytologic and/or surgical pathology follow-up within 6 months, were further studied. Most UNSAT UCyto specimens were bladder washing/barbotage (BW/BB), and the most common indication for UCyto was cancer surveillance. The main cause of UNSAT UCyto was low cellularity. There were 5 false-negative (FN) results for high-grade urothelial carcinoma (HGUC), which corresponds to an overall NPV of 84.4%. NPV was highest for patients with UCyto for hematuria, and for patients with BW/BB as UCyto specimen type. CONCLUSIONS: Our results show that UNSAT diagnoses have a lower NPV than that typical of NHGUC diagnoses, and should be managed accordingly.

The value of the UroVysion® FISH assay in the risk-stratification of patients with "atypical urothelial cells" in urinary cytology specimens.

BACKGROUND: The aim of this study was to evaluate the potential use of the UroVysion® fluorescent in situ hybridization test (U-FISH) to stratify the risk of urothelial carcinoma (UC) in patients with a diagnosis of "atypical urothelial cells" (AUC) in urinary tract cytology (UTCy). METHODS: Using a histologic diagnosis of UC and respectively of high grade UC (HGUC) within 12 months of the index UTCy as a reference standard, we determined the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy of U-FISH for patients with AUC diagnosed 2008 to 2014. RESULTS: Of the 377 patients with AUC, 62 (16.45%) were diagnosed with UC (29 low grade UC and 33 HGUC) within 12 months. U-FISH were uninformative in 45 (11.94%), positive in 63 (16.71%) and negative in 269 (71.35%). UC was diagnosed more frequently in patients with positive than in those with negative U- FISH results (31/63, 49.21% vs. 25/269, 9.29%, P < 0.0001). The sensitivity, specificity, PPV, NPV and accuracy of U-FISH in the setting of AUC were 44.64%, 81.82%, 47.17%, 80.25%, and 71.91% for UC and respectively 48.39%, 78.77%. 28.3%, 89.81%, and 74.29% for HGUC. U-FISH showed a high false positive rate (28/53, 52.83%) that remained high even after extended follow-up, arguing against "anticipatory positive" results. CONCLUSIONS: U-FISH allows risk stratification in patients with AUC. However, its usefulness is diminished by the high false-positive rate, making it important to interpret U- FISH results in the patient's clinical context. Diagn. Cytopathol. 2017;45:481-500. © 2017 Wiley Periodicals, Inc.

Vaginal fine-needle aspiration: A useful alternative to biopsy.

BACKGROUND: Vaginal fine-needle aspiration (FNA) is infrequently performed to assess palpable lesions. We perform the first multi-institutional study to evaluate this procedure. METHODS: We retrospectively reviewed vaginal FNAs performed at two institutions for the past 27 years. Clinical, cytological and histological data were reviewed and tabulated. RESULTS: We identified 43 specimens from 39 patients (mean age 56 years, range 18-86 years). Twenty four patients (62%) had prior malignancies from the following sites: gynecologic tract (22), bladder (1), and breast (1). Twenty four specimens were malignant, 18 were benign (including eight cases from patients with prior malignancy) and one was unsatisfactory. Of 28 FNA specimens from patients with a malignant history, 18 (64%) were positive for malignancy. The most common malignancies were metastatic ovarian carcinoma (50%), squamous cell carcinoma (25%), and uterine cancer (17%). Mean time to metastasis/recurrence was 16 months and was longest in patients with ovarian metastasis (26 months) compared to other malignancies (P = 0.002). The most common benign diagnoses were cysts (33%) and inflammation (22%). In 27 cases with histological correlation, there were 20 true positives, six true negatives and one false negative (sensitivity =95%, specificity =100%). Seven patients had a recent Pap test with two true positives, two true negatives, and three false negatives (sensitivity = 40%, specificity = 100%). CONCLUSION: Vaginal FNA is usually performed to rule out a secondary malignancy, often of ovarian origin. Vaginal metastases from extra-gynecologic sites are rare. FNA is both highly sensitive and specific and may be a safe and effective alternative to biopsy. Diagn. Cytopathol. 2016;44:665-669. © 2016 Wiley Periodicals, Inc.

Evidence-based adequacy criteria for urinary bladder barbotage cytology.

INTRODUCTION: Adequacy criteria are well established in some areas of cytopathology to prevent false negative diagnoses. To date, no such criteria have been proposed and validated for urinary tract specimens. Our aim was to determine a cellularity cutoff point that significantly affects the sensitivity of detecting high-grade or in situ urothelial carcinoma (HGUC or UCIS) in bladder barbotage/washing specimens. MATERIALS AND METHODS: Bladder barbotage specimens collected in liquid-based media were selected. Specimens diagnosed as "positive for HGUC" (with histologic confirmation) composed the study group, with negative cases as control specimens. Samples were serially diluted and ThinPrep slides of decreasing cellularity were made and reviewed for diagnosis and cellularity. In a retrospective validation study, we identified cases with a "negative for malignancy" bladder barbotage/washing and a surgical pathology diagnosis of UCIS or HGUC (ie, false negative cytology). Cellularity was assessed. RESULTS: A distinct difference in sensitivity was noted at a cutoff point of 2644 (20 per 10 high-power fields) urothelial cells. Sensitivities increased for atypical or higher (68.3% versus 100%) and HGUC (43.3% versus 88.0%) after application of this cutoff point with high statistical significance (P = 0.001 and 0.0001, respectively). For the retrospective review, cases below the cutoff point were reclassified as unsatisfactory, and sensitivity rose from 76.3% to 84.8% (P = 0.0027). CONCLUSIONS: Our results indicate that, in the absence of atypical or malignant cells, an adequate bladder barbotage specimen should have a minimum of 2644 (20 per 10 high-power fields) well-visualized, well-preserved urothelial cells to increase the positive predictive value of this test.