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Aim: To train and individually validate the neuropathologists in digital primary diagnosis and frozen section reporting using a novel protocol endorsed by the Royal College of Pathologists. The protocol allows early exposure to live digital reporting in a risk mitigated environment., Methods: Two specialist neuropathologists completed training in the use of a digital microscopy system for primary neuropathological diagnosis and frozen section assessment. Participants were exposed to training sets of 20 histology cases and 10 frozen sections designed to help them identify their personal digital diagnostic pitfalls. Following this, the pathologists viewed 340 live, complete neuropathology cases. All primary diagnoses were made on digital slides with immediate glass slide reconciliation before final case sign-out., Results: There was 100% clinical concordance between the digital slide and glass slide assessment of frozen section cases for each pathologist, and these assessments corresponded with the ground truth diagnoses obtained from examination of definitive histology. For primary diagnosis, there was complete clinical concordance between digital slide and glass slide diagnosis in 98.1% of cases. The majority of discordances were related to grading differences attributable to mitotic count differences., Conclusion: Neuropathologists can develop the ability to make primary digital diagnosis competently and confidently following a course of individual training and validation., Competing Interests: Competing interests: DT and BJW are part of the Northern Pathology Imaging Co-Operative, which is supported by Leica Biosystems and Roche Ventana. Leeds Teaching Hospitals NHS Trust has a collaborative research partnership with Leica Biosystems for digital pathology deployment., (© Author(s) (or their employer(s)) 2021. No commercial re-use. See rights and permissions. Published by BMJ.)

Numerous clinical pathology departments are deploying or planning to deploy digital pathology systems for all or part of their diagnostic output. Digital pathology is an evolving technology, and it is important that departments uphold or improve on current standards. Leeds Teaching Hospitals NHS Trust has been scanning 100% of histology slides since September 2018. In this practical paper, we will share our approach to training and validation, which has been incorporated into the Royal College of Pathologists' guidance for digital pathology implementation. We will offer an overview of the Royal College endorsed training and validation protocol and the evidence base on which it is based. We will provide practical advice on implementation of the protocol and highlight areas of digital reporting that can prove difficult for the novice digital pathologist. In addition, we will share a detailed topographical list of types of diagnostic tasks and features which should form the basis of digital slide training sets., Competing Interests: Competing interests: Leeds Teaching Hospitals NHS Trust has a collaborative partnership with Leica Biosystems for a research digital pathology deployment. Both authors are part of the Northern Pathology Imaging Co-Operative., (© Author(s) (or their employer(s)) 2020. No commercial re-use. See rights and permissions. Published by BMJ.)

An ever-increasing number of clinical pathology departments are deploying, or planning to deploy digital pathology systems for all, or part of their diagnostic output. Digital pathology is an evolving technology, and it is important that departments uphold or improve on current standards. Leeds Teaching Hospitals NHS Trust has been scanning 100% of histology slides since September 2018, and has developed validation and validation protocols to train 38 histopathology consultants in primary digital diagnosis. In this practical paper, we will share our approach to ISO inspection of our digital pathology service, which resulted in successful ISO accreditation for primary digital diagnosis. We will offer practical advice on what types of procedure and documentation are necessary, both from the point of view of the laboratory and your reporting pathologists. We will explore topics including risk assessment, standard operating procedures, validation and training, calibration and quality assurance, and provide a checklist of the key digital pathology components you need to consider in your inspection preparations. The continuous quest for quality and safety improvements in our practice should underpin everything we do in pathology, including our digital pathology operations. We hope this publication will make it easier for subsequent departments to successfully achieve ISO 15189 accreditation and feel confident in their digital pathology services., Competing Interests: Competing interests: Leeds Teaching Hospitals NHS Trust has a collaborative partnership with Leica Biosystems for a research digital pathology deployment., (© Author(s) (or their employer(s)) 2019. No commercial re-use. See rights and permissions. Published by BMJ.)

Aims: To consider the value proposition of digitisation of clinical immunohistochemistry services, and to develop an approach to digital immunohistochemistry implementation and validation in a large clinical laboratory., Methods: A methodology for slide scanning in the laboratory was developed, in addition to a novel validation exercise, to allow pathologists to identify the strengths and weaknesses of digital immunohistochemistry reporting, and train in digital immunohistochemistry slide assessment., Results: A total of 1480 digital immunohistochemistry slides were assessed by 24 consultant pathologists, with complete clinical concordance between the digital and the glass slide assessment observed. Certain stains were identified as being difficult/time consuming to assess using ×20 digital slides. These stains were rescanned at ×40, which improved the confidence of the pathologists to make a digital assessment. Full digitisation of immunohistochemistry slides was achieved, introducing six new steps into the pre-existing laboratory workflow., Conclusions: While initially encountering challenges in terms of workflow, our experience showed that a well-designed, adequately resourced and well-managed scanning process can minimise the delay in slides being made available for review. Our approach to validation highlighted the need for careful assessment of a digital pathology system and scanning protocols before pathologists are expected to transfer from the light microscope to the digital microscope for routine immunohistochemistry assessment., Competing Interests: Competing interests: St James University Hospital Leeds has a collaborative partnership with Leica Biosystems for digital pathology deployment., (© Author(s) (or their employer(s)) 2019. No commercial re-use. See rights and permissions. Published by BMJ.)

Diagnostic histopathology departments are experiencing unprecedented economic and service pressures, and many institutions are now considering digital pathology as part of the solution. In this document, a follow on to our case for adoption report, we provide information and advice to help departments create their own clear, succinct, individualised business case for the clinical deployment of digital pathology., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2019. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Aim: To canvass the UK pathology community to ascertain current levels of digital pathology usage in clinical and academic histopathology departments, and prevalent attitudes to digital pathology., Methods: A 15-item survey was circulated to National Health Service and academic pathology departments across the UK using the SurveyMonkey online survey tool. Responses were sought at a departmental or institutional level. Where possible, departmental heads were approached and asked to complete the survey, or forward it to the most relevant individual in their department. Data were collected over a 6-month period from February to July 2017., Results: 41 institutes from across the UK responded to the survey. 60% (23/39) of institutions had access to a digital pathology scanner, and 60% (24/40) had access to a digital pathology workstation. The most popular applications of digital pathology in current use were undergraduate and postgraduate teaching, research and quality assurance. Investigating the deployment of digital pathology in their department was identified as a high or highest priority by 58.5% of institutions, with improvements in efficiency, turnaround times, reporting times and collaboration in their institution anticipated by the respondents. Access to funding for initial hardware, software and staff outlay, pathologist training and guidance from the Royal College of Pathologists were identified as factors that could enable respondent institutions to increase their digital pathology usage., Conclusion: Interest in digital pathology adoption in the UK is high, with usage likely to increase in the coming years. In light of this, pathologists are seeking more guidance on safe usage., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Aim: To train and individually validate a group of breast pathologists in specialty-specific digital primary diagnosis by using a novel protocol endorsed by the Royal College of Pathologists' new guideline for digital pathology. The protocol allows early exposure to live digital reporting, in a risk-mitigated environment, and focuses on patient safety and professional development., Methods and Results: Three specialty breast pathologists completed training in the use of a digital microscopy system, and were exposed to a training set of 20 challenging cases, designed to help them identify personal digital diagnostic pitfalls. Following this, the three pathologists viewed a total of 694 live, entire breast cases. All primary diagnoses were made on digital slides, with immediate glass slide review and reconciliation before final case sign-out. There was complete clinical concordance between the glass and digital impression of the case in 98.8% of cases. Only 1.2% of cases had a clinically significant difference in diagnosis/prognosis on glass and digital slide reads. All pathologists elected to continue using the digital microscope as the standard for breast histopathology specimens, with deferral to glass for a limited number of clinical/histological scenarios as a safety net., Conclusion: Individual training and validation for digital primary diagnosis allows pathologists to develop competence and confidence in their digital diagnostic skills, and aids safe and responsible transition from the light microscope to the digital microscope., (© 2017 John Wiley & Sons Ltd.)

This document clarifies the strategic context of digital pathology adoption, defines the different use cases a healthcare provider may wish to consider as part of a digital adoption and summarises existing reasons for digital adoption and its potential benefits. The reader is provided with references to the relevant literature, and illustrative case studies. The authors hope this report will be of interest to healthcare providers, pathology managers, departmental heads, pathologists and biomedical scientists that are considering digital pathology, deployments or preparing business cases for digital pathology adoption in clinical settings. The information contained in this document can be shared and used in any documentation the reader wishes to present for their own institutional case for adoption report or business case., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)