From the Department of Pathology, School of Medicine, Stanford University, Stanford, California (Rojansky, Jhun, Dussaq, Chirieleison, Nirschl, Born, Montine, Ryan, Shen, Tan, Vogel, Yang, Folkins).
Anatomic Pathology and Clinical Laboratories (Fralick, Hetherington, Macasaet, Young), Stanford Health Care, Stanford, California.
Arch Pathol Lab Med. 2023 Mar 1;147(3):359-367. doi: 10.5858/arpa.2021-0438-OA.
CONTEXT.—: Stanford Pathology began stepwise subspecialty implementation of whole slide imaging (WSI) in 2018 soon after the first US Food and Drug Administration approval. In 2020, during the COVID-19 pandemic, the Centers for Medicare & Medicaid Services waived the requirement for pathologists to perform diagnostic tests in Clinical Laboratory Improvement Amendments (CLIA)-licensed facilities. This encouraged rapid implementation of WSI across all surgical pathology subspecialties.
OBJECTIVE.—: To present our experience with validation and implementation of WSI at a large academic medical center encompassing a caseload of more than 50 000 cases per year.
DESIGN.—: Validation was performed independently for 3 subspecialty services with a diagnostic concordance threshold above 95%. Analysis of user experience, staffing, infrastructure, and information technology was performed after department-wide expansion.
RESULTS.—: Diagnostic concordance was achieved in 96% of neuropathology cases, 100% of gynecologic pathology cases, and 98% of immunohistochemistry cases. After full implementation, 8 high-capacity scanners were operational, with whole slide images generated on greater than 2000 slides per weekday, accounting for approximately 80% of histologic slides at Stanford Medicine. Multiple modifications in workflow and information technology were needed to improve performance. Within months of full implementation, most attending pathologists and trainees had adopted WSI for primary diagnosis.
CONCLUSIONS.—: WSI across all surgical subspecialities is achievable at scale at an academic medical center; however, adoption required flexibility to adjust workflows and develop tailored solutions. WSI at scale supported the health and safety of medical staff while facilitating high-quality patient care and education during COVID-19 restrictions.
斯坦福病理学于 2018 年在美国食品和药物管理局首次批准后开始逐步实施全玻片成像(WSI),并专注于专业领域。2020 年,在 COVID-19 大流行期间,医疗保险和医疗补助服务中心免除了病理学家在临床实验室改进修正案(CLIA)许可设施中进行诊断测试的要求。这鼓励了所有外科病理学专业领域快速实施 WSI。
介绍我们在一个大型学术医疗中心实施 WSI 的经验,该中心每年的病例量超过 50000 例。
对 3 个诊断符合率阈值超过 95%的专业服务进行独立验证。在部门全面扩展后,对用户体验、人员配备、基础设施和信息技术进行分析。
神经病理学病例的诊断符合率达到 96%,妇科病理学病例的诊断符合率达到 100%,免疫组织化学病例的诊断符合率达到 98%。全面实施后,8 台高容量扫描仪投入使用,每天生成的全玻片图像超过 2000 张,占斯坦福医学中心组织学玻片的 80%以上。为了提高性能,需要对工作流程和信息技术进行多次修改。在全面实施后的几个月内,大多数主治病理医生和学员已经采用 WSI 进行初步诊断。
在学术医疗中心,所有外科专业都可以实现全玻片成像,但是需要灵活性来调整工作流程并开发定制的解决方案。大规模的 WSI 支持了医疗人员的健康和安全,同时在 COVID-19 限制期间促进了高质量的患者护理和教育。