Fraggetta Filippo, L'Imperio Vincenzo, Ameisen David, Carvalho Rita, Leh Sabine, Kiehl Tim-Rasmus, Serbanescu Mircea, Racoceanu Daniel, Della Mea Vincenzo, Polonia Antonio, Zerbe Norman, Eloy Catarina
European Society of Digital and Integrative Pathology (ESDIP), Rua da Constituição n°668, 1° Esq/Traseiras, 4200-194 Porto, Portugal.
Pathology Unit, "Gravina" Hospital, Caltagirone, ASP Catania, Via Portosalvo 1, 95041 Caltagirone, Italy.
Diagnostics (Basel). 2021 Nov 22;11(11):2167. doi: 10.3390/diagnostics11112167.
The interest in implementing digital pathology (DP) workflows to obtain whole slide image (WSI) files for diagnostic purposes has increased in the last few years. The increasing performance of technical components and the Food and Drug Administration (FDA) approval of systems for primary diagnosis led to increased interest in applying DP workflows. However, despite this revolutionary transition, real world data suggest that a fully digital approach to the histological workflow has been implemented in only a minority of pathology laboratories. The objective of this study is to facilitate the implementation of DP workflows in pathology laboratories, helping those involved in this process of transformation to identify: (a) the scope and the boundaries of the DP transformation; (b) how to introduce automation to reduce errors; (c) how to introduce appropriate quality control to guarantee the safety of the process and (d) the hardware and software needed to implement DP systems inside the pathology laboratory. The European Society of Digital and Integrative Pathology (ESDIP) provided consensus-based recommendations developed through discussion among members of the Scientific Committee. The recommendations are thus based on the expertise of the panel members and on the agreement obtained after virtual meetings. Prior to publication, the recommendations were reviewed by members of the ESDIP Board. The recommendations comprehensively cover every step of the implementation of the digital workflow in the anatomic pathology department, emphasizing the importance of interoperability, automation and tracking of the entire process before the introduction of a scanning facility. Compared to the available national and international guidelines, the present document represents a practical, handy reference for the correct implementation of the digital workflow in Europe.
在过去几年中，为诊断目的而实施数字病理学（DP）工作流程以获取全切片图像（WSI）文件的兴趣有所增加。技术组件性能的不断提高以及食品药品监督管理局（FDA）对用于初步诊断的系统的批准，引发了对应用DP工作流程的更多兴趣。然而，尽管发生了这一革命性转变，但实际数据表明，只有少数病理实验室实施了完全数字化的组织学工作流程方法。本研究的目的是促进病理实验室中DP工作流程的实施，帮助参与这一转型过程的人员确定：（a）DP转型的范围和界限；（b）如何引入自动化以减少错误；（c）如何引入适当的质量控制以确保流程安全；以及（d）在病理实验室内实施DP系统所需的硬件和软件。欧洲数字与综合病理学学会（ESDIP）通过科学委员会成员之间的讨论提供了基于共识的建议。因此，这些建议基于小组成员的专业知识以及虚拟会议后达成的共识。在发布之前，这些建议由ESDIP董事会成员进行了审查。这些建议全面涵盖了解剖病理科数字工作流程实施的每一个步骤，强调了在引入扫描设备之前互操作性、自动化和整个流程跟踪的重要性。与现有的国家和国际指南相比，本文件是欧洲正确实施数字工作流程的实用便捷参考。
