Tarik M. Elsheikh

Techniques for thyroid FNA: a synopsis of the National Cancer Institute Thyroid Fine-Needle Aspiration State of the Science Conference.

The National Cancer Institute (NCI) sponsored the NCI Thyroid fine‐needle aspiration (FNA) State of the Science Conference on October 22–23, 2007 in Bethesda, MD. The 2‐day meeting was accompanied by a permanent informational website and several on‐line discussion periods between May 1 and December 15, 2007 (http://thyroidfna.cancer.gov). This document summarizes matters addressing manual and ultrasound guided FNA technique and related issues. Specific topics covered include details regarding aspiration needles, devices, and methods, including the use of core needle biopsy; the pros and cons of anesthesia; the influence of thyroid lesion location, size, and characteristics on technique; the role of ultrasound in the FNA of a palpable thyroid nodule; the advantages and disadvantages of various specialists performing a biopsy; the optimal number of passes and tissue preparation methods; sample adequacy criteria for solid and cystic nodules, and management of adverse reactions from the procedure. (http://thyroidfna.cancer.gov/pages/info/agenda/) Diagn. Cytopathol. 2008;36:407–424.

Comparison of thinprep and cytospin preparations in the evaluation of exfoliative cytology specimens

There exists limited literature comparing ThinPrep (TP) with conventional cytospins (CS) in nongynecologic specimens.

Intraoperative cytologic diagnosis of suprasellar and sellar cystic lesions.

The intraoperative distinction of craniopharyngiomas (CP) and cystic pituitary adenomas (PA) from other intracranial parasellar cystic lesions can significantly modify the extent of surgery and reduce postoperative morbidity. Frozen‐section diagnosis may be limited by the scant tissue available for examination. The imprint cytology of six parasellar cystic lesions is examined, along with their radiologic and histologic findings. These include two Rathkes cleft cysts (RCC), three CP, and one cystic PA. RCC showed scattered clusters of cuboidal cells with prominent cilia. Cystic PA demonstrated clusters of monomorphic round cells with minimal cytoplasm. CP displayed “wet” keratin and clusters of squamous cells with a palisaded border. In all six cases, cytology supported the final histologic diagnosis. In one case, the intraoperative diagnosis was based solely on cytologic examination. Cytology can contribute significantly to an accurate intraoperative diagnosis of parasellar cystic lesions and potentially modify surgical management. Diagn. Cytopathol. 1999;20:137–147.

Predicting screening sensitivity from workload in gynecologic cytology: A review

Recent studies have shown that it is possible to correlate workload or epithelial cell abnormality (ECA) adjusted workload with screening sensitivity. The results show that for manual screening of conventional smears or SurePath slides, screening sensitivity begins to fall with workloads as low as 30 slides/day. For review of slides with the ThinPrep Imaging System, screening sensitivity appears to be better correlated with ECA adjusted workload (workload × ECA rate) than workload alone. Screening sensitivity with the ThinPrep imager appears to fall at ECA adjusted workloads of 7 slides/day at a threshold of ASCUS and above and LSIL, and slightly lower for HSIL. This corresponds to 70 slides/day at an ECA rate of 10%. The variance in these models is likely high reflecting a wide range of individual cytotechnologist performance. Strategies to most effectively incorporate this data in the management of workload in the laboratory are reviewed. Diagn. Cytopathol. 2011.

Sensitivity and workload for manual and automated gynecologic screening: Best current estimates

Sensitivity for screening gynecologic cytology appears to be correlated with workload, but data in the literature is limited. We gathered all known published data that included independently estimated measures of sensitivity and workload, for manual and automated screening, including individual cytotechnologist (CT) and laboratory data. We then attempted to synthesize the best estimates of sensitivity with workload volume. While this interpretation is limited by the scarcity of collected data and the few assumptions needed to combine the data, our results suggest that manual and automated screening correlate differently with workload. Manual screening was directly related to total workload volume, appeared to reach near 100% sensitivity for some individual CTs at workloads of ∼30 slides/day, and decreased to below 80% sensitivity at ∼70 slides /day. Most CTs performed at a higher sensitivity than the laboratory averages, but a small subset of CTs had significantly lower sensitivities with similar workload volumes. Sensitivity of automated screening, on the other hand, was more closely correlated with epithelial cell abnormality (ECA)‐adjusted workload (ECA × total slides/day). While these results are preliminary and additional studies are warranted to confirm them, our results may be useful in monitoring workload limits in gynecologic cytology. Diagn. Cytopathol. 2010.

ASC/SIL ratio for cytotechnologists: A survey of its utility in clinical practice

The atypical squamous cell to squamous intraepithelial lesion (ASC/SIL) ratio for cytotechnologists (CTs) may correlate with screening sensitivity in some laboratory settings. Whether this ratio can be applied to other laboratory settings is not known. We conducted a survey of nine cytology laboratories and correlated the ASC/SIL ratio of individual CTs with other laboratory characteristics.

Low grade squamous intraepithelial lesion, epithelial cell abnormality-adjusted workload, and the thinprep imaging system

Previous studies have shown a negative correlation between screening sensitivity using the ThinPrep Imaging System (TIS) and epithelial cell abnormality (ECA) adjusted workload (ECA rate × actual slides screened/day) at the thresholds of atypical squamous cells of undetermined significance (ASCUS) and high‐grade squamous intraepithelial lesion (HSIL). We sought to determine if a similar correlation could be shown at the threshold of low grade squamous intraepithelial lesion (LSIL). Using data in seven manuscripts from the literature that contain sufficient information, the change in screening sensitivity using the TIS compared with manual screening was negatively correlated with ECA adjusted workload (y = −3.75x + 54, R2 = 0.104). Using the sensitivity of manual screening of 79% for manual screening at a threshold of LSIL from the original TIS trial, 100% sensitivity could be achieved at an ECA adjusted workload of approximately seven slides/day, the same workload that achieves 100% sensitivity at a threshold of ASCUS and slightly higher than the threshold for HSIL. We conclude that the ECA adjusted workload is a valuable method to assess workload for the TIS at the threshold of LSIL. Laboratories using the TIS should restrict workload to seven ECA adjusted slides/day (maximum actual slides/day = 700/ECA percentage). Diagn. Cytopathol. 2012.

Controls in quality assessment in gynecologic cytology: A rational approach to workload limits for the ThinPrep imaging system

Major components of good quality assurance (QA) in cytology laboratories are measuring the screening accuracy of cytotechnologists (CTs) and determining appropriate workload limits for them. Currently, the FDA approved workload limits for image assisted Paps, however, are too high. In addition, the CLIA 88 mandated QA measures, by themselves, are insufficient to accurately measure the screening performance of CTs. Although the use of “controls” is fundamental to good practice in the clinical laboratory; this has not been emphasized in gynecologic cytology. In this review, we underscore the importance of using controls, such as monitoring morning and afternoon abnormal rates, in assessing CT performance and assigning reasonable workload limits. Using controls, however, requires significant alteration in the laboratory workflow, and much lower and variable workload limits for CTs, compared to those approved by FDA. Diagn. Cytopathol. 2010;38:772–775.

HSIL, epithelial cell abnormality-adjusted workload, and the Thinprep imaging system

Previous studies have suggested that the sensitivity of the ThinPrep Imaging System (TIS) for high‐grade intraepithelial lesion (HSIL) and worse may be decreased at workloads above 100 slides/day. On the other hand, at a threshold of atypical squamous cells of undetermined significance (ASCUS) and above, sensitivity of the TIS appears to more closely correlated with epithelial cell abnormality (ECA)‐adjusted workload (ECA rate × actual slides/day) rather than total workload. We sought to determine if the sensitivity of the TIS for HSIL could also be shown to be correlated with ECA‐adjusted workload. The change in sensitivity for HSIL from manual screening to TIS screening consistently correlated negatively with ECA‐adjusted workload both in the original Food and Drug Administration trial study and in independent studies available in the literature. Both sources suggest that sensitivity near 100% can be achieved with ECA‐adjusted workloads of 5–7 slides/day. For a laboratory with an ECA rate of 10%, this represents a total workload of 50–70 slides/day. We conclude that measuring the ECA‐adjusted workload is a valuable method to assess workload for the ThinPrep Imaging System. Diagn. Cytopathol. 2012.

Does the new automated “HALO” nipple aspiration fluid system really deliver as promised? The answer is “No, but…”: A literature review of the role of breast fluid cytology in cancer risk assessment

The HALO breast Pap test is a new automated nipple aspiration fluid (NAF) system that was recently introduced into the market. In an extensive marketing campaign directed principally toward OB/GYN practices, including endorsements from few local news media, HALO has been promoted as the “new Pap screening test for breast.” Physicians are encouraged to perform this test on all women, as part of their annual examination, with claims that HALO will detect breast cancers as early as 10 years before mammography. These arguments are made more appealing to physicians offices by highlighting the potential positive financial impact on their practices, without consuming physician time, as medical assistants or technicians can perform this test. As a result of this directed campaign, cytology laboratories are increasingly confronted with implementing the HALO system and clinicians are increasingly soliciting pathologists input regarding its validity. Yet, there is no data available regarding this new system, outside rare reports sponsored by the manufacturer. In this discussion, I examine the pros and cons of this new NAF system, including literature review of breast fluid cytology, and how it relates to breast cancer risk assessment. Diagn. Cytopathol. 2009.