Digital Cytopathology Quality Guidelines
- PMID: 41492911
- DOI: 10.1111/vcp.70094
Digital Cytopathology Quality Guidelines
Abstract
Digital cytopathology is increasingly used in veterinary medicine, yet standardized quality guidance for its safe and effective implementation has been lacking. As more reference laboratories and individual clinics adopt this technology, challenges related to sample preparation, staining variability, scanner capabilities, software design, operator training, and limitations in optical resolution have emerged. To address these issues, the ASVCP Quality Assurance and Laboratory Standards Committee developed comprehensive guidelines for the preanalytical, analytical, and postanalytical phases of digital cytologic evaluation, with the aim of enhancing diagnostic accuracy, improving workflow efficiency, and supporting safer clinical decision-making. The target audience is veterinary pathologists, residents, laboratory personnel, and practices currently using or planning to adopt digital cytopathology. Key recommendations include ensuring appropriate sample preparation and placement to support accurate digital capture; selecting and validating scanners and software with performance characteristics appropriate for cytologic specimens; implementing standardized training for operators and pathologists; and establishing procedures for assessing digital image quality, managing incomplete or low-quality scans, and determining when glass slide review is required. Because digital cytopathology continues to evolve rapidly and the current evidence base remains limited, these guidelines are intended as a minimum standard and should be revisited within five years to incorporate emerging QA data and technological advancements.
© 2026 American Society for Veterinary Clinical Pathology.
References
References
-
- T. Inoue and Y. Yagi, “Color Standardization and Optimization in Whole Slide Imaging,” Clinical and Diagnostic Pathology 4, no. 1 (2020): 10, https://doi.org/10.15761/cdp.1000139.
-
- R. Kwiecien, A. Kopp‐Schneider, and M. Blettner, “Concordance Analysis: Part 16 of a Series on Evaluation of Scientific Publications,” Deutsches Ärzteblatt International 108, no. 30 (2011): 515–521, https://doi.org/10.3238/arztebl.2011.0515.
-
- A. J. Evans, R. W. Brown, M. M. Bui, et al., “Validating Whole Slide Imaging Systems for Diagnostic Purposes in Pathology,” Archives of Pathology & Laboratory Medicine 146, no. 4 (2022): 440–450, https://doi.org/10.5858/arpa.2020‐0723‐CP.
-
- N. Chantziantoniou, “BestCyte Primary Screening of 500 ThinPrep Pap Test Thin‐Layers: 3 Cytologists' Interobserver Diagnostic Concordance With Predicate Manual Microscopy Relative to Truth Reference Diagnoses Defining NILM, ASCUS+, LSIL+, and ASCH+ Thresholds for Specificity, Sensitivity, and Equivalency Grading,” Journal of Pathology Informatics 14 (2023): 100182, https://doi.org/10.1016/j.jpi.2022.100182.
-
- F. Bonsembiante, U. Bonfanti, F. Cian, L. Cavicchioli, B. Zattoni, and M. E. Gelain, “Diagnostic Validation of a Whole Slide Imaging Scanner in Cytological Samples: Diagnostic Accuracy and Comparison With Light Microscopy,” Veterinary Pathology 56, no. 3 (2019): 429–434, https://doi.org/10.1177/0300985818825128.
Resources
-
- Royal College of Pathology, “Digital Pathology (rcpath.org),” accessed August 5, 2025. https://www.rcpath.org/profession/digital‐pathology.html.
-
- “Best Practice Recommendations for Implementing Digital Pathology (rcpath.org),” accessed August 5, 2025. https://www.rcpath.org/resourceLibrary/best‐practice‐recommendations‐for....
-
- “CLIA Summary,” accessed August 5, 2025, https://www.cms.gov/Regulations‐and‐Guidance/Legislation/CLIA/index.html.
-
- “Clinical Laboratory Standards Institute,” accessed August 5, 2025, www.clsi.org.
-
- “ISO's International Standard 15189:2022 Medical Laboratories—Requirements for Quality and Competence,” n.d. (Fee for Documentation), https://www.iso.org/standard/76677.html.
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