The management of implementing a digital pathology workflow

More and more departments are implementing a digital workflow. This overview is intended to provide a high-level rational management approach to navigating some of the major issues that one is likely to encounter. Key stake holder engagement from the main domains: hospital administration, IT and laboratory management and leadership is essential. A business case taking into account local needs is the first step. The impact of a “disruptive” technology on working habits and work flow needs to be assessed and changes need to be resourced and catered for. Choice of scanner and software depends on local needs and also ability for seamless integration in the laboratory information system. Service contracts and redundancy in the eventuality of scanner failure/breakdown is critical and needs to be planned for. Pathologist management should be phased with formal validation and monitoring.     

Colour in digital pathology: a review

Colour is central to the practice of pathology because of the use of coloured histochemical and immunohistochemical stains to visualize tissue features. Our reliance upon histochemical stains and light microscopy has evolved alongside a wide variation in slide colour, with little investigation into the implications of colour variation. However, the introduction of the digital microscope and whole‐slide imaging has highlighted the need for further understanding and control of colour. This is because the digitization process itself introduces further colour variation which may affect diagnosis, and image analysis algorithms often use colour or intensity measures to detect or measure tissue features. The US Food and Drug Administration have released recent guidance stating the need to develop a method of controlling colour reproduction throughout the digitization process in whole‐slide imaging for primary diagnostic use. This comprehensive review introduces applied basic colour physics and colour interpretation by the human visual system, before discussing the importance of colour in pathology. The process of colour calibration and its application to pathology are also included, as well as a summary of the current guidelines and recommendations regarding colour in digital pathology.     

The framework of pathology: good laboratory practice by quantitative and molecular methods

Combined confocal laser scan microscopy (CLSM) and Fourier analysis (FA) by non-pathologists of dermal collagen bundle orientation recently gave results superior to subjective evaluation by experts. According to Good Laboratory Practice (GLP) criteria, combined CLSM/FA has not yet been adequately tested to replace current collagen evaluation, but this will not take long. Non-pathologists (clinicians) will then have taken over a laboratory test historically belonging to pathology. A general trend in this direction may develop, because pathologists seem not always to care enough about clinical significance, reproducibility and prognostic value, and new demands for innovative methods. Quantitative image analysis (QIA) and molecular methods are reproducible, inexpensive, and easy to perform; they often have greater value than classical evaluations and their cost-benefit ratio is good. However, their acceptance is not as widespread as one would expect and theoretical reasons which have been advanced do not provide a satisfactory explanation. A formal implementation study was therefore performed, in which an attempt was made to modernize a classical pathology laboratory. An external customer satisfaction investigation showed that 96% of the clinicians were 'very satisfied' (the highest rating possible) with the completed innovations, contrasting with low satisfaction at the beginning. Lack of primary innovative leadership among pathologists was judged to be the dominant cause preventing implementation. Pathologists should focus on carefully reacting to new clinical needs, using GLP criteria. Reproducibility and predictive accuracy should be major themes in any pathology practice.     

Digital breast pathology: validation and training for primary digital practice

Digital pathology is a technology which is transforming the way in which breast histopathology specimens are assessed, reported and reviewed. Large scale clinical laboratory deployments of whole slide imaging systems are occurring in diagnostic pathology departments across the world, requiring laboratory and diagnostic staff to navigate new skills and workflows. Transferring from conventional light microscopy assessment of breast specimens to the use of whole slide images (WSI) can be a challenging experience. This article describes an approach to training and validation for breast consultant histopathologists, which has been used and adapted at a number of sites. Examples of types of case that are suitable for training, and some of the potential “pitfalls” of digital reporting for the novice are described, and practical advice regarding clinical digital breast workflow is shared.     

A mission-based reporting system applied to an academic pathology department

We report how data from the University of California (UC) Davis mission-based reporting system (MBR) can be used to define contributions for each division within a Department of Pathology based on faculty rank and series, and to evaluate whether these contributions are in alignment with the missions of the department and the goals of the school's leadership. MBR summary reports were generated for each division within the Department of Pathology; these reports illustrated the average contribution for each faculty rank and series in each of the following missions: investigative/creative work (research), teaching, clinical service, and administrative/community service. All divisions contributed equally to the teaching mission, averaging approximately 1/3 of a faculty member's time. Research was the primary mission for faculty in both the Research and the Clinical Pathology divisions, whereas clinical service was the primary mission for Anatomic Pathology. Both Anatomic Pathology and Clinical Pathology also played a large role in the administration/community service mission. These roles were appropriate based on the division's distribution of faculty in each of the faculty series. The average contribution to both the research and administrative/community service missions were larger for the Department of Pathology than it was for the school as a whole. The Department of Pathology's average contribution to both the teaching and clinical service missions was less than the school's average. We conclude that MBR data creates unique profiles for divisions and the department and enables interdepartmental comparisons that would not be possible by other means. Within the context of our school, the present analysis illustrates that the Department of Pathology is fulfilling the expectations of the school's leadership. In a more general sense, these profiles allow appropriate monitoring of the workforce, funds flow analysis, allocation of resources, and strategic planning in an academic medical center.     

Artificial intelligence in digital pathology: a roadmap to routine use in clinical practice

The use of artificial intelligence will transform clinical practice over the next decade and the early impact of this will likely be the integration of image analysis and machine learning into routine histopathology. In the UK and around the world, a digital revolution is transforming the reporting practice of diagnostic histopathology and this has sparked a proliferation of image analysis software tools. While this is an exciting development that could discover novel predictive clinical information and potentially address international pathology workforce shortages, there is a clear need for a robust and evidence-based framework in which to develop these new tools in a collaborative manner that meets regulatory approval. With these issues in mind, the NCRI Cellular Molecular Pathology (CM-Path) initiative and the British In Vitro Diagnostics Association (BIVDA) have set out a roadmap to help academia, industry, and clinicians develop new software tools to the point of approved clinical use. © 2019 Pathological Society of Great Britain and Ireland. Published by John Wiley & Sons, Ltd.     

Low-contact and high-interconnectivity pathology (LC&HI Path): post-COVID19-pandemic practice of pathology

The COVID-19 pandemic situation may be viewed as an opportunity to accelerate some of the ongoing transformations in modern pathology. This refers primarily to the digitalisation of the practice of tissue and cellular pathology diagnostics. However, it is also an opportunity to analyse the modus operandi of a discipline that has been practised in a similar manner for more than 100 years. The challenge is to define the next generation of interconnectivity tools that would be necessary to achieve a new operational model that, while ensuring low face-to-face interaction between the main players of the diagnostic pipeline, allows maximum interconnectivity to serve our patients and the immediate teaching and research needs associated with clinical tissue/cellular samples. This viewpoint aims to describe what this new paradigm, a low-contact and high-interconnectivity pathology (LC&HC Path) operation, may require in the near future.     

Integration of digital pathology in multidisciplinary breast site group rounds

Whole slide scanning and digitizing an entire glass slide technology opens multiple opportunities for integration in clinical practice. Clinical applications other than primary diagnosis include the use of digitized slides in multidisciplinary rounds. Integration of this emerging technology requires not only adaptation by pathologists but also investment in infrastructure for hardware and software components, electronic storage solutions, support from clinicians and hospital administration as well as training personal. The process of replacing conventional glass with digitized slides in pathology case presentation in multidisciplinary rounds is discussed highlighting the strengths and weaknesses of this transition. Successful implementation relies heavily on careful preliminary workflow process design and support from leaders within Anatomic Pathology and the cancer center.     

Research issues in forensic pathology: a survey of academic institutions employing forensic pathologists

In an effort to characterize research efforts in forensic pathology, a questionnaire was sent to a representative of each of the 14 academic medical centers that employ full-time faculty forensic pathologists. Responses were received from all 14 (100%) of the institutions queried, representing a total of 39 forensic pathology faculty positions; 21 positions were tenure track and 18 positions were clinical or other tracks. Of the 39 positions, 25 positions (64%) at 10 institutions required some degree of research or scholarly output. Of the 25 forensic pathologists with a research imperative, only 3 (12%) were principal investigators or co-investigators on funded forensic pathology-based projects. The major limitation cited by respondents on the performance of forensic pathology research was the lack of protected time from service responsibilities. Fellowship training in forensic pathology was available at 6 of the 14 respondent institutions. Of these institutions, 4 (67%) had a research requirement for trainees, and 4 (67%) provided research training. In conclusion, very few US medical schools currently employ full-time faculty forensic pathologists. Of these, only a small number of institutions prioritize research by these faculty members. Scant federal funds are available to support research in forensic pathology. Few forensic pathology fellowship programs provide research training. To achieve a robust research agenda in forensic pathology that is sufficient to support the needs of the criminal justice and public health systems will require a paradigm shift in the medicolegal death investigative system and investment by federal agencies.     

Factors that impact turnaround time of surgical pathology specimens in an academic institution

Turnaround time of laboratory results is important for customer satisfaction. The College of American Pathologists' checklist requires an analytic turnaround time of 2 days or less for most routine cases and lets every hospital define what a routine specimen is. The objective of this study was to analyze which factors impact turnaround time of nonbiopsy surgical pathology specimens. We calculated the turnaround time from receipt to verification of results (adjusted for weekends and holidays) for all nonbiopsy surgical specimens during a 2-week period. Factors studied included tissue type, number of slides per case, decalcification, immunohistochemistry, consultations with other pathologists, and diagnosis. Univariate and multivariate analyses were performed. A total of 713 specimens were analyzed, 551 (77%) were verified within 2 days and 162 (23%) in 3 days or more. Lung, gastrointestinal, breast, and genitourinary specimens showed the highest percentage of cases being signed out in over 3 days. Diagnosis of malignancy (including staging of the neoplasia), consultation with other pathologists, having had a frozen section, and use of immunohistochemical stains were significantly associated with increased turnaround time in univariate analysis. Decalcification was not associated with increased turnaround time. In multivariate analysis, consultation with other pathologists, use of immunohistochemistry, diagnosis of malignancy, and the number of slides studied continued to be significantly associated with prolonged turnaround time. Our findings suggest that diagnosis of malignancy is central to significantly prolonging the turnaround time for surgical pathology specimens, thus institutions that serve cancer centers will have longer turnaround time than those that do not.     

Applications and implications of whole-slide imaging in breast pathology

Technological advances in whole slide imaging (WSI) technology and artificial intelligence (AI) applications in recent years have resulted in increasing adoption of this paradigm shift technology. This brings with it many advantages, new challenges, and potential adaptations to the microscopic assessment of specimens that pathologists need to be aware of. This article describes the applications and implications of WSI within the context of the reporting of breast pathology specimens. Challenging diagnostic entities in digital breast pathology are presented and the key areas in which AI could be useful in breast pathology are highlighted.     

The use of digital images in pathology

Digital images are routinely used by the publishing industry, but most diagnostic pathologists are unfamiliar with the technology and its possibilities. This review aims to explain the basic principles of digital image acquisition, storage, manipulation and use, and the possibilities provided not only in research, but also in teaching and in routine diagnostic pathology. Images of natural objects are usually expressed digitally as ‘bitmaps’—rectilinear arrays of small dots. The size of each dot can vary, but so can its information content in terms, for example, of colour, greyscale or opacity. Various file formats and compression algorithms are available. Video cameras connected to microscopes are familiar to most pathologists; video images can be converted directly to a digital form by a suitably equipped computer. Digital cameras and scanners are alternative acquisition tools of relevance to pathologists. Once acquired, a digital image can easily be subjected to the digital equivalent of any conventional darkroom manipulation and modern software allows much more flexibility, to such an extent that a new tool for scientific fraud has been created. For research, image enhancement and analysis is an increasingly powerful and affordable tool. Morphometric measurements are, after many predictions, at last beginning to be part of the toolkit of the diagnostic pathologist. In teaching, the potential to create dramatic yet informative presentations is demonstrated daily by the publishing industry; such methods are readily applicable to the classroom. The combination of digital images and the Internet raises many possibilities; for example, instead of seeking one expert diagnostic opinion, one could simultaneously seek the opinion of many, all around the globe. It is inevitable that in the coming years the use of digital images will spread from the laboratory to the medical curriculum and to the whole of diagnostic pathology. © 1997 John Wiley & Sons, Ltd.     

The future of pathology is digital

Information, archives, and intelligent artificial systems are part of everyday life in modern medicine. They already support medical staff by mapping their workflows with shared availability of cases’ referral information, as needed for example, by the pathologist, and this support will be increased in the future even more.In radiology, established standards define information models, data transmission mechanisms, and workflows. Other disciplines, such as pathology, cardiology, and radiation therapy, now define further demands in addition to these established standards. Pathology may have the highest technical demands on the systems, with very complex workflows, and the digitization of slides generating enormous amounts of data up to Gigabytes per biopsy. This requires enormous amounts of data to be generated per biopsy, up to the gigabyte range.Digital pathology allows a change from classical histopathological diagnosis with microscopes and glass slides to virtual microscopy on the computer, with multiple tools using artificial intelligence and machine learning to support pathologists in their future work.     

Working at the microscope: analysis of the activities involved in diagnostic pathology

Randell R, Ruddle R A, Quirke P, Thomas R G & Treanor D
(2012) Histopathology  60, 504–510
Working at the microscope: analysis of the activities involved in diagnostic pathology Aims: To study the current work practice of histopathologists to inform the design of digital microscopy systems. Methods and results: Four gastrointestinal histopathologists were video‐recorded as they undertook their routine work. Analysis of the video data shows a range of activities beyond viewing slides involved in reporting a case. There is much overlapping of activities, supported by the ‘eyes free’ nature of the pathologists’ interaction with the microscope. The order and timing of activities varies according to consultant. Conclusions: In order to support the work of pathologists adequately, digital microscopy systems need to provide support for a range of activities beyond viewing slides. Digital microscopy systems should support multitasking, while also providing flexibility so that pathologists can adapt their use of the technology to their own working patterns.     

Curriculum content and evaluation of resident competency in clinical pathology (laboratory medicine): a proposal

Ten years have passed since the Graylyn Conference Report on Laboratory Medicine Clinical Pathology training was issued. Over that period, the Accreditation Council for Graduate Medical Education substantially revised the requirements for training programs; the American Board of Pathology amended both the requirements and the periods needed for certification; and the discipline itself, along with the broader discipline of pathology, evolved significantly. Recently, a curriculum proposal in anatomical pathology was published as a potential template to be used by training programs to help meet these new and evolving needs. Toward the same end, the Academy of Clinical Laboratory Physicians and Scientists has now developed a template for a curriculum in clinical pathology (laboratory medicine), taking into account newly designated and revised areas of residency core competency, the alterations in training requirements promulgated by the Accreditation Council for Graduate Medical Education and American Board of Pathology, and the rapidly developing nature of the discipline itself. The proposed clinical pathology curriculum defines goals and objectives for training, provides guidelines for instructional methods, and gives examples of how outcomes can be assessed. This curriculum is presented as a potentially helpful outline for use by pathology residency training programs.