Dissecting the Business Case for Adoption and Implementation of Digital Pathology: A White Paper from the Digital Pathology Association

Lujan, Giovanni; Quigley, Jennifer C; Hartman, Douglas J.; Parwani, Anil V.; Roehmholdt, Brian; Meter, Bryan Van; Ardon, Orly; Hanna, Matthew G.; Kelly, Dan; Sowards, Chelsea; Montalto, Michael; Bui, Marilyn M.; Zarella, Mark D.; LaRosa, Victoria; Slootweg, Gerard; Retamero, Juan Antonio; Lloyd, Mark C.; Madory, James E.; Bowman, Doug

doi:10.4103/jpi.jpi_67_20

Cited by 53 publications

(52 citation statements)

References 64 publications

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“…Most articles addressing digital QC report a low scanning error rate, usually around 1–1.5%%, and, at most, less than 5% [ 1 , 7 , 9 , 22 ]. However, most studies only report the errors detected by the scanner and not by visual assessment of WSI image quality.…”

Section: Discussionmentioning

confidence: 99%

“…The reasons for low DP adoption in private practice laboratories are mostly related to the initial high costs of implementation, necessary workflow adjustments and pathologists’ receptivity. This is counterbalanced with future prospects of laboratory expenses reduction [ 8 , 9 ], easy remote access to cases and simple web-based case consultation by expert colleagues and improved data security [ 10 , 11 ]. In addition, already available digital tools to assist diagnosis (such as easy measuring, pinpointing or annotating relevant areas, etc.)…”

Section: Introductionmentioning

confidence: 99%

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Digital Pathology Implementation in Private Practice: Specific Challenges and Opportunities

Montezuma

Monteiro²,

Fraga

et al. 2022

Diagnostics

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Digital pathology (DP) is being deployed in many pathology laboratories, but most reported experiences refer to public health facilities. In this paper, we report our experience in DP transition at a high-volume private laboratory, addressing the main challenges in DP implementation in a private practice setting and how to overcome these issues. We started our implementation in 2020 and we are currently scanning 100% of our histology cases. Pre-existing sample tracking infrastructure facilitated this process. We are currently using two high-capacity scanners (Aperio GT450DX) to digitize all histology slides at 40×. Aperio eSlide Manager WebViewer viewing software is bidirectionally linked with the laboratory information system. Scanning error rate, during the test phase, was 2.1% (errors detected by the scanners) and 3.5% (manual quality control). Pre-scanning phase optimizations and vendor feedback and collaboration were crucial to improve WSI quality and are ongoing processes. Regarding pathologists’ validation, we followed the Royal College of Pathologists recommendations for DP implementation (adapted to our practice). Although private sector implementation of DP is not without its challenges, it will ultimately benefit from DP safety and quality-associated features. Furthermore, DP deployment lays the foundation for artificial intelligence tools integration, which will ultimately contribute to improving patient care.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Digital Pathology Implementation in Private Practice: Specific Challenges and Opportunities

Montezuma

Monteiro²,

Fraga

et al. 2022

Diagnostics

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“…Despite the upfront investment required, early adopters of digital pathology systems reported higher laboratory efficiency, overall cost-effectiveness, and no decrease in quality of patient services. 30 In addition, there is a high degree of concordance between findings made using traditional light microscopic observation of glass-mounted H&E-stained tissue sections and findings based on observation of WSIs. 14,31,32…”

Section: Introductionmentioning

confidence: 78%

Scientific and Regulatory Policy Committee Points to Consider: Primary Digital Histopathology Evaluation and Peer Review for Good Laboratory Practice (GLP) Nonclinical Toxicology Studies

et al. 2022

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The Society of Toxicologic Pathology’s Scientific and Regulatory Policy Committee formed a working group to consider the present and future use of digital pathology in toxicologic pathology in general and specifically its use in primary evaluation and peer review in Good Laboratory Practice (GLP) environments. Digital histopathology systems can save costs by reducing travel, enhancing organizational flexibility, decreasing slide handling, improving collaboration, increasing access to historical images, and improving quality and efficiency through integration with laboratory information management systems. However, the resources to implement and operate a digital pathology system can be significant. Given the magnitude and risks involved in the decision to adopt digital histopathology, this working group used pertinent previously published survey results and its members’ expertise to create a Points-to-Consider article to assist organizations with building and implementing digital pathology workflows. With the aim of providing a comprehensive perspective, the current publication summarizes aspects of digital whole-slide imaging relevant to nonclinical histopathology evaluations, and then presents points to consider applicable to both primary digital histopathology evaluation and digital peer review in GLP toxicology studies. The Supplemental Appendices provide additional tabulated resources.

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“…This can be obtained by the use of a DICOM-capable archive, although the eventual loss of quality related to the compression/conversion from one image extension to another is still a matter of debate. Finally, identifying the amount and type of storage needed is important, as it is one of the highest costs when implementing DP and needs to be adapted to the calculated yearly needs of each laboratory [15].…”

Section: Assignment Of Images To the Correct Case/patient Filementioning

confidence: 99%

“…Independently of the type of strategy chosen to switch towards a digital visualization of images (LIS-centric, vendor based or third-party software), the new system should be able to integrate every possible instrument (e.g., one or more scanners from same or different vendors with the possibility to manage different images from a variety of sources), preferably associated with a tracking system because of automation and innovation. The cost-effectiveness of DP has already been documented in implementation models that discuss the scope of investment, the potential return on investment, and cost-savings of DP, as well as any proposed income deriving from the adoption of WSIs [15]. Moreover, the adequate adaptation of a routine clinical workflow can finally lead to an optimization of resources (e.g., space, time, personnel, and equipment).…”

Section: Introductionmentioning

confidence: 99%

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)

Fraggetta¹,

L’Imperio

Ameisen³

et al. 2021

Diagnostics

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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.

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Dissecting the Business Case for Adoption and Implementation of Digital Pathology: A White Paper from the Digital Pathology Association

Cited by 53 publications

References 64 publications

Digital Pathology Implementation in Private Practice: Specific Challenges and Opportunities

Digital Pathology Implementation in Private Practice: Specific Challenges and Opportunities

Scientific and Regulatory Policy Committee Points to Consider: Primary Digital Histopathology Evaluation and Peer Review for Good Laboratory Practice (GLP) Nonclinical Toxicology Studies

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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