Difference between revisions of "Journal:Best practice recommendations for the implementation of a digital pathology workflow in the anatomic pathology laboratory by the European Society of Digital and Integrative Pathology (ESDIP)"
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The interest in implementing [[digital pathology]] (DP) [[workflow]]s 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 histological workflow has been implemented in only a minority of [[Clinical laboratory|pathology laboratories]]. | The interest in implementing [[digital pathology]] (DP) [[workflow]]s 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 histological workflow has been implemented in only a minority of [[Clinical laboratory|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 | The objective of this study is to facilitate the implementation of DP workflows in pathology laboratories, helping those involved in this process of transformation with: (a) how to identify the scope and the boundaries of the DP transformation; (b) how to introduce [[Laboratory automation|automation]] to reduce errors; (c) how to introduce appropriate [[quality control]] to guarantee the safety of the process; and (d) addressing 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 broader scientific committee. The recommendations are thus based on the expertise of 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 a digital workflow in the [[Anatomical pathology|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 a digital workflow in Europe. | ||
''Keywords'': digital pathology, anatomic pathology workflow, whole slide imaging, laboratory information system | ''Keywords'': digital pathology, anatomic pathology workflow, whole slide imaging, laboratory information system | ||
==Introduction== | ==Introduction== | ||
The interest in implementing [[digital pathology]] (DP) [[workflow]]s to obtain whole slide image (WSI) files for diagnostic purposes has increased in the last few years. This is in part due to the opportunities offered by WSI, e.g., telepathology and image analysis, including computational pathology tools based on [[artificial intelligence]] (AI) methods. The increasing performance of technical components and the [[Food and Drug Administration]] (FDA) approval of systems for primary diagnosis [1] led to increased interest in applying DP workflows. Moreover, in the last few years, several studies evaluating performance demonstrated the non-inferiority of WSI compared to conventional light microscopy [2,3,4] for primary [[Histology|histological]] diagnosis. This may help to alleviate concerns about the possible risk of DP-related diagnostic errors. [5] Indeed, the restrictions suffered during the [[COVID-19]] [[pandemic]], the reduction in the number of pathologists, and the increase in workload, along with a rising number and complexity of clinical cases, also raised the interest in DP. | |||
Several definitions for DP have been proposed so far [6,7], a common opinion being that DP encompasses the photographic documentation of the macroscopy of the specimens (“gross pathology”), the digitization of glass slides (virtual microscopy), and telepathology. By some definitions, DP involves merely the digitization of glass slides. In this study, “DP” is significantly distanced from the reductive paradigm of only glass slide digitization, moving towards a more integrative approach that comprises interventions in all stations of work in the [[Clinical laboratory|pathology laboratory]], introducing and supporting innovation. DP implicitly consists of all the associated technologies to allow improvements and innovations in workflow, including, for instance, [[laboratory information system]]s (LIS), digital dictation, dashboard and workflow management, electronic specimen labelling and tracking, and [[LIS feature#Synoptic reporting|synoptic reporting]] tools. | |||
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: (a) identify the scope and the boundaries of the DP transformation; (b) introduce [[Laboratory automation|automation]] to reduce errors; (c) introduce appropriate [[quality control]] to guarantee the safety of the process; and (d) implement the hardware and software needed to implement DP systems inside the pathology laboratory. Since several recommendations and guidelines have already been proposed, primarily focusing on the validation of WSI for clinical purposes or on the technical environment, this paper mainly covers DP implementation and all the prerequisites for a pathology laboratory to change from an analogue to a digital workflow. [8] Considering all that has been reported about DP workflow implementation and its associated benefits, it is anticipated that this new methodology has many advantages that should be attractive and convenient for all pathology laboratories worldwide, independently of their dimension, workload, number of pathologists, or type of activity (e.g., academic/nonacademic, private/public). [6,7,9,10,11] | |||
Revision as of 23:07, 4 December 2021
| Full article title | Best practice recommendations for the implementation of a digital pathology workflow in the anatomic pathology laboratory by the European Society of Digital and Integrative Pathology (ESDIP) |
|---|---|
| Journal | Diagnostics |
| Author(s) | Fraggetta, Filippo; L'Imperio, Vincenzo; Ameisen, David; Carvalho, Rita; Leh, Sabine; Kiehl, Tim-Rasmus; Serbanescu, Mircea; Racoceanu, Daniel; Mea, Vincenzo D.; Polonia, Antonio; Zerbe, Norman; Eloy, Catarina |
| Author affiliation(s) | European Society of Digital and Integrative Pathology, Azienda Sanitaria Provinciale Di Catania, University of Milano-Bicocca, Imginit SAS, Charité – Universitätsmedizin Berlin, Haukeland University Hospital, University of Bergen, University of Medicine and Pharmacy of Craiova, Sorbonne Université, University of Udine |
| Primary contact | Email: celoy at ipatimup dot pt |
| Year published | 2021 |
| Volume and issue | 11(11) |
| Article # | 2167 |
| DOI | 10.3390/diagnostics11112167 |
| ISSN | 2075-4418 |
| Distribution license | Creative Commons Attribution 4.0 International |
| Website | https://www.mdpi.com/2075-4418/11/11/2167/htm |
| Download | https://www.mdpi.com/2075-4418/11/11/2167/pdf (PDF) |
 |
This article should be considered a work in progress and incomplete. Consider this article incomplete until this notice is removed. |
Abstract
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 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 with: (a) how to identify 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) addressing 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 broader scientific committee. The recommendations are thus based on the expertise of 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 a 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 a digital workflow in Europe.
Keywords: digital pathology, anatomic pathology workflow, whole slide imaging, laboratory information system
Introduction
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. This is in part due to the opportunities offered by WSI, e.g., telepathology and image analysis, including computational pathology tools based on artificial intelligence (AI) methods. The increasing performance of technical components and the Food and Drug Administration (FDA) approval of systems for primary diagnosis [1] led to increased interest in applying DP workflows. Moreover, in the last few years, several studies evaluating performance demonstrated the non-inferiority of WSI compared to conventional light microscopy [2,3,4] for primary histological diagnosis. This may help to alleviate concerns about the possible risk of DP-related diagnostic errors. [5] Indeed, the restrictions suffered during the COVID-19 pandemic, the reduction in the number of pathologists, and the increase in workload, along with a rising number and complexity of clinical cases, also raised the interest in DP.
Several definitions for DP have been proposed so far [6,7], a common opinion being that DP encompasses the photographic documentation of the macroscopy of the specimens (“gross pathology”), the digitization of glass slides (virtual microscopy), and telepathology. By some definitions, DP involves merely the digitization of glass slides. In this study, “DP” is significantly distanced from the reductive paradigm of only glass slide digitization, moving towards a more integrative approach that comprises interventions in all stations of work in the pathology laboratory, introducing and supporting innovation. DP implicitly consists of all the associated technologies to allow improvements and innovations in workflow, including, for instance, laboratory information systems (LIS), digital dictation, dashboard and workflow management, electronic specimen labelling and tracking, and synoptic reporting tools.
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: (a) identify the scope and the boundaries of the DP transformation; (b) introduce automation to reduce errors; (c) introduce appropriate quality control to guarantee the safety of the process; and (d) implement the hardware and software needed to implement DP systems inside the pathology laboratory. Since several recommendations and guidelines have already been proposed, primarily focusing on the validation of WSI for clinical purposes or on the technical environment, this paper mainly covers DP implementation and all the prerequisites for a pathology laboratory to change from an analogue to a digital workflow. [8] Considering all that has been reported about DP workflow implementation and its associated benefits, it is anticipated that this new methodology has many advantages that should be attractive and convenient for all pathology laboratories worldwide, independently of their dimension, workload, number of pathologists, or type of activity (e.g., academic/nonacademic, private/public). [6,7,9,10,11]
References
Notes
This presentation is faithful to the original, with only a few minor changes to presentation, spelling, and grammar. In some cases important information was missing from the references, and that information was added.
