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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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)
Emblem-important-yellow.svg 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]

So far, there are several possibilities to transit and to manage “images” in a digital workflow: an LIS-based approach[12][13], a scanner vendor approach[7], or an intermediate software approach (e.g., Linköping University[14]). Independently of the type of strategy chosen, in order to switch towards a digital visualization of images (whether 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 the 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). These are intended as recommendations and suggestions for the implementation of the full DP workflow in the routine clinical practice of anatomic pathology laboratories. The introduction of a DP workflow even allows the implementation of computational pathology tools such as AI.

The following sections explain, point-by-point, the steps needed for the progressive, secure, and efficient transition into a DP workflow. Regarding cytopathology, there are several barriers that still need to be overcome for routine cytopathology to go digital and support wider adoption and sustainability. Therefore, the present study mainly focuses on histopathology and the justification (Box 1) for its transition to a DP workflow.


Box 1. The justification of transitioning histopathology workflows to digital pathology workflows.
1. Digital pathology is pathology, a holistic approach that comprehends interventions in all stations of work at the pathology laboratory, introducing innovation.

2. Digital pathology is attractive and convenient for pathology laboratories worldwide.
3. Digital pathology represents a safer and more efficient way of working and should be considered the new standard in pathology.
4. Implementation of a digital pathology workflow is a key milestone to patients fully benefiting from the potential of WSI and a prerequisite for the application of AI in routine diagnostics.

Involvement of the team in the digital pathology transformation of the laboratory

The implementation of digital pathology requires a multidisciplinary approach from the very beginning. The leading team should involve in-house participants (e.g., pathologists, laboratory technicians, administrative staff) and the hospital’s IT and technical services.[6] IT services might be organized in different ways depending on the size of the department and depending on local or national policies. For example, IT services may be provided by individuals, by a separate department, or by a subcontractor. The most important thing is that these groups work together and that they form a team.

Subsequently, close collaboration with companies providing the digital pathology system and the LIS will become necessary. Especially in larger departments, digital transformation will usually be organized as a project that includes a project manager, a steering group, and different working groups. There are several ways of introducing the topic and designing the appropriate options for the laboratory at hand, and it might be useful to visit pathology departments with digital workflows to learn from their successes and failures. There are a couple of papers that share such experiences and provide valuable information.[6][7] Describing user scenarios is another method to both understand the needs of one’s own laboratory and communicate those needs to the IT and technical departments, as well as potential vendors. In addition, before starting a tender, it is helpful to gather information about suppliers and products.

To obtain a successful implementation of DP and to avoid deficiencies, the multidisciplinary team that is going to lead the “digital revolution” in each department should follow some crucial steps, as previously reported. In particular, for the correct and rapid implementation of DP in every department, it is advisable to create awareness and appropriate work conditions, incentivize participation, encourage communication among the team members, and monitor the outcomes of this revolution. This approach could help in facing the heterogeneous patterns of reactions that different actors of the team could express, including the “enthusiasts,” the “sceptics,” and the “undecided.” All the possible measures to increase the trust and involvement of pathologists should be applied to all staff members.

To establish a successful DP workflow, a thorough stakeholder analysis should be carried out, and a communication strategy should be established based on this analysis. The team must ensure that all internal stakeholders (including pathologists, laboratory personnel and administrative staff) are continuously informed from the beginning. In this setting, sharing the vision of DP with laboratory and administrative personnel, encouraging them to provide feedback, expressing potential concerns and suggestions (e.g., using frequent meetings on-site), and providing appropriate discussion during all phases of the deployment will facilitate a safe and effective implementation. The team must be aware that DP should be perceived as an integral part of the laboratory workflow rather than an “add-on.”[6] The contingent situation due to the COVID-19 pandemic can be further leveraged to boost the implementation of DP in the laboratories, stressing the need to maintain pathology services by making it possible for pathologists to work from home [16].

Implementing DP as the standard laboratory practice also requires learning new technical skills to capture all the advantages of this technology. Just as significant as consulting the internal stakeholders is the involvement of IT services. IT will be crucial in many aspects of the project (e.g., handling LIS adaptations, integrations, storage, testing etc.). The involvement should start in the early phases of the transition. For example, consider conducting a laboratory office tour to establish communication with the other components of the project, using clear language. This gives your team the opportunity to understand what is expected and what is potentially achievable from your deployment, and what each professional group will be expected to contribute in terms of time and staff. Explain your ideas for future digital workflows and see what potential dependencies and solutions your IT colleagues can generate.


References

  1. ↑ Evans, Andrew J.; Bauer, Thomas W.; Bui, Marilyn M.; Cornish, Toby C.; Duncan, Helena; Glassy, Eric F.; Hipp, Jason; McGee, Robert S. et al. (1 November 2018). "US Food and Drug Administration Approval of Whole Slide Imaging for Primary Diagnosis: A Key Milestone Is Reached and New Questions Are Raised" (in en). Archives of Pathology & Laboratory Medicine 142 (11): 1383–1387. doi:10.5858/arpa.2017-0496-CP. ISSN 0003-9985. http://meridian.allenpress.com/aplm/article/142/11/1383/102979/US-Food-and-Drug-Administration-Approval-of-Whole. 
  2. ↑ Snead, David R. J.; Tsang, Yee-Wah; Meskiri, Aisha; Kimani, Peter K.; Crossman, Richard; Rajpoot, Nasir M.; Blessing, Elaine; Chen, Klaus et al. (2016). "Validation of digital pathology imaging for primary histopathological diagnosis" (in en). Histopathology 68 (7): 1063–1072. doi:10.1111/his.12879. ISSN 1365-2559. https://onlinelibrary.wiley.com/doi/abs/10.1111/his.12879. 
  3. ↑ Goacher, Edward; Randell, Rebecca; Williams, Bethany; Treanor, Darren (1 January 2017). "The Diagnostic Concordance of Whole Slide Imaging and Light Microscopy: A Systematic Review" (in en). Archives of Pathology & Laboratory Medicine 141 (1): 151–161. doi:10.5858/arpa.2016-0025-RA. ISSN 0003-9985. http://meridian.allenpress.com/aplm/article/141/1/151/65950/The-Diagnostic-Concordance-of-Whole-Slide-Imaging. 
  4. ↑ Mukhopadhyay, Sanjay; Feldman, Michael D.; Abels, Esther; Ashfaq, Raheela; Beltaifa, Senda; Cacciabeve, Nicolas G.; Cathro, Helen P.; Cheng, Liang et al. (1 January 2018). "Whole Slide Imaging Versus Microscopy for Primary Diagnosis in Surgical Pathology: A Multicenter Blinded Randomized Noninferiority Study of 1992 Cases (Pivotal Study)" (in en). American Journal of Surgical Pathology 42 (1): 39–52. doi:10.1097/PAS.0000000000000948. ISSN 0147-5185. PMC PMC5737464. PMID 28961557. https://journals.lww.com/00000478-201801000-00006. 
  5. ↑ Evans, Andrew J.; Salama, Mohamed E.; Henricks, Walter H.; Pantanowitz, Liron (1 July 2017). "Implementation of Whole Slide Imaging for Clinical Purposes: Issues to Consider From the Perspective of Early Adopters" (in en). Archives of Pathology & Laboratory Medicine 141 (7): 944–959. doi:10.5858/arpa.2016-0074-OA. ISSN 0003-9985. http://meridian.allenpress.com/aplm/article/141/7/944/65708/Implementation-of-Whole-Slide-Imaging-for-Clinical. 
  6. ↑ 6.0 6.1 6.2 6.3 6.4 Treanor, D.; Williams, B.; Hussain, B. et al. (July 2018). "The Leeds Guide to Digital Pathology" (PDF). University of Leeds. https://www.virtualpathology.leeds.ac.uk/research/clinical/docs/2018/pdfs/18778_Leeds%20Guide%20to%20Digital%20Pathology_Brochure_A4_final_hi.pdf. Retrieved 10 November 2021. 
  7. ↑ 7.0 7.1 7.2 7.3 LabPON Laboratorium Pathologie Oost-Nederland (October 2016). "How to Go Digital in Pathology" (PDF). LabPON Laboratorium Pathologie Oost-Nederland. https://www.usa.philips.com/c-dam/b2bhc/us/landing-pages/pdxus/how-to-go-digital-in-pathology.pdf. Retrieved 10 November 2021. 
  8. ↑ Retamero, Juan Antonio; Aneiros-Fernandez, Jose; del Moral, Raimundo G. (1 February 2020). "Complete Digital Pathology for Routine Histopathology Diagnosis in a Multicenter Hospital Network" (in en). Archives of Pathology & Laboratory Medicine 144 (2): 221–228. doi:10.5858/arpa.2018-0541-OA. ISSN 0003-9985. http://meridian.allenpress.com/aplm/article/144/2/221/433661/Complete-Digital-Pathology-for-Routine. 
  9. ↑ Fraggetta, Filippo; Garozzo, Salvatore; Zannoni, GianFranco; Pantanowitz, Liron; Rossi, EstherDiana (2017). "Routine digital pathology workflow: The Catania experience" (in en). Journal of Pathology Informatics 8 (1): 51. doi:10.4103/jpi.jpi_58_17. ISSN 2153-3539. PMC PMC5760840. PMID 29416914. http://www.jpathinformatics.org/text.asp?2017/8/1/51/221132. 
  10. ↑ Fraggetta, Filippo; Caputo, Alessandro; Guglielmino, Rosa; Pellegrino, Maria Giovanna; Runza, Giampaolo; L'Imperio, Vincenzo (16 October 2021). "A Survival Guide for the Rapid Transition to a Fully Digital Workflow: The “Caltagirone Example”" (in en). Diagnostics 11 (10): 1916. doi:10.3390/diagnostics11101916. ISSN 2075-4418. PMC PMC8534326. PMID 34679614. https://www.mdpi.com/2075-4418/11/10/1916. 
  11. ↑ Eloy, Catarina; Vale, João; Curado, Mónica; Polónia, António; Campelos, Sofia; Caramelo, Ana; Sousa, Rui; Sobrinho-Simões, Manuel (15 November 2021). "Digital Pathology Workflow Implementation at IPATIMUP" (in en). Diagnostics 11 (11): 2111. doi:10.3390/diagnostics11112111. ISSN 2075-4418. PMC PMC8620597. PMID 34829458. https://www.mdpi.com/2075-4418/11/11/2111. 
  12. ↑ Sinard, John H.; Castellani, William J.; Wilkerson, Myra L.; Henricks, Walter H. (1 March 2015). "Stand-alone Laboratory Information Systems Versus Laboratory Modules Incorporated in the Electronic Health Record" (in en). Archives of Pathology & Laboratory Medicine 139 (3): 311–318. doi:10.5858/arpa.2013-0711-SO. ISSN 1543-2165. http://meridian.allenpress.com/aplm/article/139/3/311/193668/Standalone-Laboratory-Information-Systems-Versus. 
  13. ↑ Sepulveda, Jorge L.; Young, Donald S. (1 August 2013). "The Ideal Laboratory Information System" (in en). Archives of Pathology & Laboratory Medicine 137 (8): 1129–1140. doi:10.5858/arpa.2012-0362-RA. ISSN 1543-2165. http://meridian.allenpress.com/aplm/article/137/8/1129/65418/The-Ideal-Laboratory-Information-System. 
  14. ↑ Asa, SylviaL; Bodén, AnnaC; Treanor, Darren; Jarkman, Sofia; Lundström, Claes; Pantanowitz, Liron (2019). "2020 vision of digital pathology in action" (in en). Journal of Pathology Informatics 10 (1): 27. doi:10.4103/jpi.jpi_31_19. ISSN 2153-3539. PMC PMC6704755. PMID 31516758. http://www.jpathinformatics.org/text.asp?2019/10/1/27/264400. 
  15. ↑ Lujan, Giovanni; Quigley, JenniferC; Hartman, Douglas; Parwani, Anil; Roehmholdt, Brian; Meter, BryanVan; Ardon, Orly; Hanna, MatthewG et al. (2021). "Dissecting the business case for adoption and implementation of digital pathology: A white paper from the digital pathology association" (in en). Journal of Pathology Informatics 12 (1): 17. doi:10.4103/jpi.jpi_67_20. ISSN 2153-3539. PMC PMC8240548. PMID 34221633. http://www.jpathinformatics.org/text.asp?2021/12/1/17/313004. 

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.

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