Internal validation testing for new technologies: Bringing telecytopathology into the mainstream

Abstract

Implementing new technology in the laboratory can improve processes and patient care, but compliance with regulatory requirements can be a significant hurdle to clear. This study provides a detailed procedure to address user training, competency assessment, and internal validation of telecytopathology simultaneously, while fulfilling regulatory requirements set forth by the College of American Pathologists and CLIA '88. Six pathologists participated in this study. Methods and materials used included a blind correlation study between diagnoses rendered via telecytopathology and via direct microscopy on 10 finalized fine needle aspiration (FNA) cases. The first step of this procedure involved each pathologist to render a diagnosis for each specimen using telecytopathology. The second step was to allow each pathologist to diagnose each specimen via direct microscopic review after a wait period of at least 6 weeks. The diagnoses rendered via telecytopathology were then compared to both the established final diagnoses and the secondary direct microscopic review diagnoses to examine interpathologist and intrapathologist reproducibility with a passing rate of 90% or better. Results of the study yielded an average concordance rate of 96.67% for interpathologist reproducibility and 95% for intrapathologist reproducibility across all participating pathologists. All participants passed the assessment with a rate of 90% or better, proving evidence of competency. This study confirmed user competency and validated telecytopathology as an effective tool for examining and diagnosing cytology FNA specimens remotely. It also satisfied regulatory compliance requirements to ensure high quality of diagnostic testing and patient care.

Rapid on-site evaluation with dynamic telecytopathology for ultrasound-guided fine-needle aspiration of head and neck nonthyroid lesions

“…However, prior to introduction of telecytopathology at our hospital in November 2009, an internal validation testing was completed which was fairly similar to a recent validation study by MaCarthy et al [21] Briefly, slides from 15 previously signed FNA cases with unequivocal benign and malignant diagnosis from various body sites were used. Trained cytotechnologists controlled the microscopes at remote site and pathologist reviewed real-time images of slides from each case at their workstation.…”

Use of a low‐cost telecytopathology method for remote assessment of thyroid FNAs

“…Telepathology has become a valuable tool in everyday pathology practice as technologies have evolved . It can be used in different scenarios, from whole slide imaging (WSI) to the dynamic transmission of images for frozen consultation . Implementation of the technique is rapidly increasing worldwide, and the US Food and Drug Administration (FDA) recently approved the use of WSI for routine sign‐out; however, it is still restricted to surgical pathology (histopathology) .…”

“…In cytopathology practice, a third factor involving the tridimensional nature of cytologic preparations may further hamper or delay its wide implementation . Although newer scanners provide software for scanning multiple levels and z‐stacking, images are still very large, and the process is tedious …”

“…However, an area in which telecytology (TC) may be implemented immediately is rapid on‐site evaluation (ROSE), which is a great tool for optimizing the adequacy and quality of cytologic samples . The cytopathologist's time is precious; and, with increasing caseloads and minimally invasive procedures, the dynamic transmission of slides rises as a useful strategy for the broad implantation of ROSE . In thyroid fine‐needle aspiration biopsy (FNAB), ROSE has significantly improved specimen adequacy, because it avoids undersampling scenarios and allows for the proper triage of materials for ancillary studies while also decreasing the mean number of needle passes, reducing patient discomfort, and reducing the incidence of complications from the procedure.…”

“…1 It can be used in different scenarios, from whole slide imaging (WSI) to the dynamic transmission of images for frozen consultation. [2][3][4][5] Implementation of the technique is rapidly increasing worldwide, and the US Food and Drug Administration (FDA) recently approved the use of WSI for routine sign-out; however, it is still restricted to surgical pathology (histopathology). 6 Impediments to the wide acceptance of telepathology include its high cost and resistance to technologic advances by experienced pathologists.…”