American Society of Cytopathology Telecytology validation recommendations for rapid on-site evaluation (ROSE).

Telecytology has multiple applications, including rapid onsite evaluation (ROSE) of fine-needle aspiration (FNA) specimens. It can enhance cytopathology practice by increasing productivity, reducing costs, and providing subspecialty expertise in areas with limited access to a cytopathologist. However, there are currently no specific validation guidelines to ensure safe practice and compliance with regulations. This initiative, promoted by the American Society of Cytopathology (ASC), intends to propose recommendations for telecytology implementation. These recommendations propose that the validation process should include testing of all hardware and software, both separately and as a whole; training of all individuals who will participate in telecytology with regular competency evaluations; a structured approach using retrospective slides with defined diagnoses for validation and prospective cases for verification and quality assurance. Telecytology processes must be integrated into the laboratory's quality management system and benchmarks for discrepancy rates between preliminary and final diagnoses should be established and monitored. Special attention should be paid to minimize discrepancies that downgrade malignant cases to benign (false positive on telecytology). Currently, billing and reimbursement codes for telecytology are not yet available. Once, they are, recommendation of the appropriate usage of these codes would be a part of the recommendations. These proposed guidelines are intended to be a resource for laboratories that are considering implementing telecytology. These recommendations can help to ensure the safe and effective use of telecytology and maximize its benefits for patients.

Molecular-derived risk of malignancy and the related positive call rate of indeterminate thyroid cytology diagnoses as quality metrics for individual cytopathologists.

BACKGROUND: Indeterminate thyroid cytopathology diagnoses represent differing degrees of risk that are corroborated by follow-up studies. However, traditional cytologic-histologic correlation may overestimate the risk of malignancy (ROM) because only a subset of cases undergo resection. Alternatively, some molecular tests provide probability of malignancy data to calculate the molecular-derived risk of malignancy (MDROM) and the positive call rate (PCR). The authors investigated MDROMs and PCRs of indeterminate diagnoses for individual cytopathologists as quality metrics. METHODS: This study was approved by the Department of Pathology Quality Improvement Program. Thyroid cytopathology diagnoses and ThyroSeq v3 results were retrieved for each cytopathologist for a 2-year period with at least 3 years of follow-up for the atypia of undetermined significance (AUS), follicular neoplasia (FN), and follicular neoplasia, oncocytic-type (ONC) cytopathologic diagnoses. MDROMs and PCRs were compared with reference ROMs and cytologic-histologic correlation outcomes. RESULTS: The overall MDROMs (and ranges for cytopathologists) for the AUS, FN, and ONC categories were 13.4% (range, 5.8%-20.8%), 28.1% (range, 22.1%-36.7%), and 27.0% (range, 19.5%-41.5%), respectively, and most individual cytopathologists' MDROMs were within reference ROM ranges. However, PCRs more effectively parsed the differences in cytopathologists' ROM performance. Although the overall PCRs were not significantly different across cytopathologists (p = .06), the AUS PCRs were quite different (p = .002). By cytologic-histologic correlation, six of 55 resected cases (10.9%) were falsely negative, and there were no false-positive cases. CONCLUSIONS: MDROMs and PCRs evaluate concordance with reference ROMs and with one another and provide individual feedback, which potentially facilitates quality improvement.

Quality metrics in non-gynecologic cytology: results from the 2022 American Society of Cytopathology survey.

INTRODUCTION: Rapid advancements in minimally invasive techniques and the discovery of molecular biomarkers have resulted in major changes in the practice of non-gynecologic cytology and have highlighted a need for novel quality assurance (QA) metrics. MATERIALS AND METHODS: To obtain data regarding the current and desired usage, methods of collection, and barriers to the implementation of non-gynecologic cytopathology QA, an 18-question survey was constructed by the Clinical Practice Committee of the American Society for Cytopathology. RESULTS: A total of 206 responses were received. Respondents included 112 (54.4%) cytopathologists, 81 (39.3%) cytotechnologists, and 13 others. Almost all (97%) acknowledged the value of assessing QA metrics in cytology. The most commonly used QA metrics were cytotechnologist-pathologist diagnostic agreement and pathologist amendment rates. The desire to implement non-gynecologic QA metrics was significantly higher among academic hospitals, relative to nonacademic facilities. A combined manual and electronic approach to collect QA data was generally used (70% of institutions). QA metrics were more often collected by the cytology laboratory supervisors (59.5%), while the evaluation was most often performed by the cytology laboratory director (76.5%). Limited staffing and laboratory information system (LIS) capabilities were cited as major challenges in the implementation of novel QA metrics. CONCLUSIONS: While the collection of quality data might be perceived as an onerous task, a thoughtful selection of quality indicators, with an inbuilt search option in LIS, can contribute to the successful implementation of non-gynecologic QA metrics.

Cell blocks in cytology: review of preparation methods, advantages, and limitations.

Cell blocks are cytologic preparations that are processed as paraffin embedded blocks in a manner comparable to formalin-fixed paraffin-embedded tissue in surgical pathology. In addition to serving as an adjunct to other cytologic preparations for morphologic diagnosis, cell blocks play an increasingly important role as they yield tissue sections that can be utilized for ancillary testing such as immunohistochemical stains and molecular studies. While essentially universally viewed as playing a pivotal role in cytopathology practice, there are various factors that limit their use in practice and contribute to dissatisfaction with cell block quality. Cell block preparation, as opposed to tissue processing in surgical pathology, is more variable with many different protocols in use today. This review explores the most commonly used cell block preparation techniques currently in use with review of the unique advantages and limitations each method presents. The goal of this work is to serve as a resource that can aid in making more informed decisions about which cell block protocol may work best for individual laboratories.

Cross-contamination in cytology processing: a review of current practice.

INTRODUCTION: New cytopreparatory technologies decrease the need for direct smears in favor of an increased use of liquid-based cytology methods. Despite these practice changes, Clinical Laboratory Improvement Amendments continue to require that cytopathology laboratories have procedures to prevent cross-contamination (CC). While the incidence of CC is not well documented, specific cytologic preparations and specimens with a high potential for CC have not been generally defined by professional guidelines or consensus. The American Society of Cytopathology Clinical Practice Committee surveyed cytology practitioners to better understand current practice related to CC in cytology. MATERIALS AND METHODS: The survey focused on four topics: (1) practice settings and demographic data; (2) current practice for meeting CC requirements; (3) practice for rapid on-site evaluation; and (4) preparation types considered high risk for CC. The survey was sent to all American Society of Cytopathology and American Society for Cytotechnology members from July 1 to August 14, 2020. RESULTS: Ninety-eight percent of laboratories had a written CC policy, with 66.18% of the policies addressing rapid on-site evaluation CC procedures. Documented cases of CC were rare. Alcohol-fixed, direct smears of Pap-stained fluids were deemed the most likely to be impacted by CC. Cell block contamination during the histologic processing were reported by 56.20% of respondents. CONCLUSIONS: Changes in practice has resulted in decreased preparation types associated with a high potential for CC. Laboratories should follow a risk-based approach to define these cases. Knowledge of practice patterns among laboratories can guide the development and refinement of policy and procedures.

Accuracy of definitive rapid onsite evaluation cytopathology diagnoses: Assessment of potentially critical diagnoses as a quality assurance measure.

INTRODUCTION: Intraprocedural rapid onsite evaluation (ROSE) of cytology specimens enhances cytopathology practice. More recently, ROSE diagnoses, like frozen section (FS) diagnoses, have guided immediate clinical decisions. In this study, we evaluated the diagnostic accuracy of definitive ROSE diagnoses in our quality assurance system over a 52-month period. MATERIALS AND METHODS: Cytopathology cases with ROSE from January 2017 to April 2021were retrieved from our laboratory information system. After excluding cases that were deferred or nondiagnostic/unsatisfactory, each definitive ROSE diagnosis (ie, negative for malignant cells or positive for malignant cells) was categorized as having agreement or disagreement with the final diagnosis. For comparison, concordance of FS diagnoses from the same time period were tabulated and compared to those of ROSE diagnoses by using χ2 testing with P < 0.05 considered statistically significant. RESULTS: Of the 1649 ROSE diagnoses, there were 15 disagreements (0.9%) with 1 final moderate interpretive disagreement (0.06%). By comparison, of the 17,469 FS diagnoses, there were 141 disagreements (0.8%) with 49 final moderate or major interpretive disagreements (0.3%). The remaining disagreements were minor. There were no statistically significant differences in the rates of final moderate and major interpretive disagreements. CONCLUSIONS: The final interpretive disagreement rates for definitive ROSE and FS diagnoses were similar in this study. Given the expanding role of ROSE and its use for immediate clinical decisions in some cases, monitoring the accuracy of definitive diagnoses may serve as an initial quality assurance measure.