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Remote digital pathology allows healthcare systems to maintain pathology operations during public health emergencies. Existing Clinical Laboratory Improvement Amendments regulations require pathologists to electronically verify patient reports from a certified facility. During the 2019 pandemic of COVID-19 disease, caused by the SAR-CoV-2 virus, this requirement potentially exposes pathologists, their colleagues, and household members to the risk of becoming infected. Relaxation of government enforcement of this regulation allows pathologists to review and report pathology specimens from a remote, non-CLIA certified facility. The availability of digital pathology systems can facilitate remote microscopic diagnosis, although formal comprehensive (case-based) validation of remote digital diagnosis has not been reported. All glass slides representing routine clinical signout workload in surgical pathology subspecialties at Memorial Sloan Kettering Cancer Center were scanned on an Aperio GT450 at ×40 equivalent resolution (0.26 µm/pixel). Twelve pathologists from nine surgical pathology subspecialties remotely reviewed and reported complete pathology cases using a digital pathology system from a non-CLIA certified facility through a secure connection. Whole slide images were integrated to and launched within the laboratory information system to a custom vendor-agnostic, whole slide image viewer. Remote signouts utilized consumer-grade computers and monitors (monitor size, 13.3–42 in.; resolution, 1280 × 800–3840 × 2160 pixels) connecting to an institution clinical workstation via secure virtual private network. Pathologists subsequently reviewed all corresponding glass slides using a light microscope within the CLIA-certified department. Intraobserver concordance metrics included reporting elements of top-line diagnosis, margin status, lymphovascular and/or perineural invasion, pathology stage, and ancillary testing. The median whole slide image file size was 1.3 GB; scan time/slide averaged 90 s; and scanned tissue area averaged 612 mm2. Signout sessions included a total of 108 cases, comprised of 254 individual parts and 1196 slides. Major diagnostic equivalency was 100% between digital and glass slide diagnoses; and overall concordance was 98.8% (251/254). This study reports validation of primary diagnostic review and reporting of complete pathology cases from a remote site during a public health emergency. Our experience shows high (100%) intraobserver digital to glass slide major diagnostic concordance when reporting from a remote site. This randomized, prospective study successfully validated remote use of a digital pathology system including operational feasibility supporting remote review and reporting of pathology specimens, and evaluation of remote access performance and usability for remote signout.

The 2020 COVID-19 crisis has had and will have many implications for healthcare, including pathology. Rising number of infections create staffing shortages and other hospital departments might require pathology employees to fill more urgent positions. Furthermore, lockdown measures and social distancing cause many people to work from home. During this crisis, it became clearer than ever what an asset digital diagnostics is to keep pathologists, residents, molecular biologists and pathology assistants engaged in the diagnostic process, allowing social distancing and a ‘need to be there’ on-the-premises policy, while working effectively from home. This paper provides an overview of our way of working during the 2020 COVID-19 crisis with emphasis on the virtues of digital pathology.

Telepathology facilitates histological diagnoses through sharing expertise between pathologists. However, the associated costs are high and frequently prohibitive, especially in low-resource settings, where telepathology would paradoxically be of paramount importance due to a paucity of pathologists.We have constructed a telepathology system (TelePi) with a budget of < €120 using the small, single-board computer Raspberry Pi Zero and its High-Quality Camera Module in conjunction with a standard microscope and open-source software. The system requires no maintenance costs or service contracts, has a small footprint, can be moved and shared across several microscopes, and is independent from other computer operating systems. TelePi uses a responsive and high-resolution web-based live stream which allows remote consultation between two or more locations. TelePi can serve as a telepathology system for remote diagnostics of frozen sections. Additionally, it can be used as a standard microscope camera for teaching of medical students and for basic research. The quality of the TelePi system compared favorable to a commercially available telepathology system that exceed its cost by more than 125-fold. Additionally, still images are of publication quality equal to that of a whole slide scanner that costs 800 times more.In summary, TelePi is an affordable, versatile, and inexpensive camera system that potentially enables telepathology in low-resource settings without sacrificing image quality.

During the last decade, a dramatic rise in the development and application of artificial intelligence (AI) tools for use in pathology services has occurred. This trend is often expected to continue and reshape the field of pathology in the coming years. The deployment of computational pathology and applications of AI tools can be considered as a paradigm shift that will change pathology services, making them more efficient and capable of meeting the needs of this era of precision medicine. Despite the success of AI models, the translational process from discovery to clinical applications has been slow. The gap between self-contained research and clinical environment may be too wide and has been largely neglected. In this review, we cover the current and prospective applications of AI in pathology. We examine its applications in diagnosis and prognosis, and we offer insights for considerations that could improve clinical applicability of these tools. Then, we discuss its potential to improve workflow efficiency, and its benefits in pathologist education. Finally, we review the factors that could influence adoption in clinical practices and the associated regulatory processes.

Correspondence to Professor Rodolfo Montironi, of Pathological Anatomy, Polytechnic University of the Marche Region (Ancona), School of Medicine, Torrette di Ancona, Italy; r.montironi@univpm.it Introduction COVID-19 pandemic has a profound impact on routine pathology services.1 Digital pathology can play a role ‘to safeguarding clinical services and pathology-based research in the current climate and in the future’.1 This digital-based approach to diagnosis represents a new way in the evaluation of surgical pathology slides from formalin-fixed paraffin-embedded tissue (FFPE). The viewing and image analysis software is downloaded from the internet, free of charge.2 Smart working from home To prevent any delay in critical patient care, virtual slides can be reviewed through the so-called smart working from home. [...]we are moving into an era of global digitalisation in the 21st-century pathology service. Most of our future activities will probably be based on what is described by Browning and colleagues1 and what we do at the present time of the pandemic, that is, ‘safely diagnosing cases from a home office using a consumer monitor’ and mini PC.8 However, we should not forget that the success on virtual slide scanning and evaluation is dependent on the role and support of paramedical and medical personnel for tissue sampling, processing, cutting and (immune-)staining as well as integration or fusion with data from other sources, including molecular pathology data.

Despite the established role of SDHB/SDHA immunohistochemistry as a valuable tool to identify patients at risk for familial succinate dehydrogenase-related pheochromocytoma/paraganglioma syndromes, the reproducibility of the assessment methods has not as yet been determined. The aim of this study was to investigate interobserver variability among seven expert endocrine pathologists using a web-based virtual microscopy approach in a large multicenter pheochromocytoma/paraganglioma cohort ( n =351): (1) 73 SDH mutated, (2) 105 non- SDH mutated, (3) 128 samples without identified SDH-x mutations, and (4) 45 with incomplete SDH molecular genetic analysis. Substantial agreement among all the reviewers was observed either with a two-tiered classification (SDHB κ =0.7338; SDHA κ =0.6707) or a three-tiered classification approach (SDHB κ =0.6543; SDHA κ =0.7516). Consensus was achieved in 315 cases (89.74%) for SDHB immunohistochemistry and in 348 cases (99.15%) for SDHA immunohistochemistry. Among the concordant cases, 62 of 69 (~90%) SDHB-/C-/D-/AF2- mutated cases displayed SDHB immunonegativity and SDHA immunopositivity, 3 of 4 (75%) with SDHA mutations showed loss of SDHA/SDHB protein expression, whereas 98 of 105 (93%) non- SDH -x-mutated counterparts demonstrated retention of SDHA/SDHB protein expression. Two SDHD -mutated extra-adrenal paragangliomas were scored as SDHB immunopositive, whereas 9 of 128 (7%) tumors without identified SDH-x mutations, 6 of 37 (~16%) VHL -mutated, as well as 1 of 21 (~5%) NF1 -mutated tumors were evaluated as SDHB immunonegative. Although 14 out of those 16 SDHB-immunonegative cases were nonmetastatic, an overall significant correlation between SDHB immunonegativity and malignancy was observed ( P =0.00019). We conclude that SDHB/SDHA immunohistochemistry is a reliable tool to identify patients with SDH-x mutations with an additional value in the assessment of genetic variants of unknown significance. If SDH molecular genetic analysis fails to detect a mutation in SDHB-immunonegative tumor, SDHC promoter methylation and/or VHL/NF1 testing with the use of targeted next-generation sequencing is advisable.

AimsAs digital pathology (DP) and whole slide imaging (WSI) technology advance and mature, there is an increasing drive to incorporate DP into the diagnostic environment. However, integration of DP into the diagnostic laboratory is a non-trivial task and filled with unexpected challenges unlike standalone implementations. We share our journey of implementing DP in the diagnostic laboratory setting, highlighting seven key guiding principles that drive the progression through implementation into deployment and beyond.MethodsThe DP implementation with laboratory information system integration was completed in 8 months, including validation of the solution for diagnostic use in accordance with College of American Pathologists guidelines. We also conducted prospective validation via paired delivery of glass slides and WSI to our pathologists postdeployment.ResultsCommon themes in our guiding principles included emphasis on workflow and being comprehensive in the approach, looking beyond pathologist user champions and expanding into an extended project team involving laboratory technicians, clerical/data room staff and archival staff. Concordance between glass slides and WSI ranged from 93% to 100% among various applications on validation. We also provided equal opportunities for every pathologist throughout the department to be competent and confident with DP through prospective validation, with overall concordance of 96% compared with glass slides, allowing appreciation of the advantages and limitations of WSI, hence enabling the use of DP as a useful diagnostic modality.ConclusionsSmooth integration of DP into the diagnostic laboratory is possible with careful planning, discipline and a systematic approach adhering to our guiding principles.

Abstract Objectives Since neuropathologic diagnosis in the developing world is hampered by limitations in technical infrastructure, trained laboratory personnel, and subspecialty-trained pathologists, the use of telepathology for diagnostic support, second-opinion consultations, and ongoing training holds promise as a means of addressing these challenges. This study aims to assess the utility of static teleneuropathology in improving neuropathologic diagnoses in low- and middle-income countries. Methods Consecutive neurosurgical biopsy and resection specimens obtained at Muhimbili National Hospital in Tanzania between July 1, 2018, and June 30, 2019, were selected for retrospective, blinded static-image neuropathologic review followed by on-site review by an expert neuropathologist. Results A total of 75 neuropathologic cases were reviewed. The agreement of static images and on-site glass diagnosis was 71% with strict criteria and 88% with less stringent criteria. This represents an overall improvement in diagnostic accuracy from 36% by general pathologists to 71% by a neuropathologist using static telepathology (or from 76% to 88% with less stringent criteria). Conclusions Telepathology offers a promising means of providing diagnostic support, second-opinion consultations, and ongoing training to pathologists practicing in resource-limited countries. Moreover, static digital teleneuropathology is an uncomplicated, cost-effective, and reliable way to achieve these goals.

[...]the remote review of these materials does not require equipment that is essential to being a separate laboratory, while maintaining the accuracy, reliability, and timeliness of laboratory results.3 As such, pathologists' freedom to practice remotely remains intact postpandemic. On May 16, 2023, the College of American Pathologists (CAP) released an advocacy update summarizing this new CLIA post-public health emergency guidance (see Table I),4 which supersedes prior CMS directions regarding digital pathology and remote practice.3,4 The COVID-19 pandemic spotlighted the importance of laboratory medicine in diagnostic testing for societies and health care systems, but the pandemic's demands simultaneously accelerated an already critical pathologist shortage.5,6 This pathologist shortage has actually been growing for decades, dating from before the 21st century.7-16 Pipeline efforts, including those by the CAP, have already been instituted to address the shortage by increasing medical student awareness of the field with postsophomore fellowships,17-21 student interest groups,22 virtual pathology electives,23 social media initiatives,24 and other curricular exposure programs.25-31 In fact, these efforts have yielded improvements nationally32 and internationally33 so far. Other studies43-45 have drawn similar conclusions to these, including remote diagnosis of intraoperative and intraprocedural consultations by frozen section and rapid on-site examination.46 Past obstacles have delayed the routine implementation of WSIs in pathology laboratories globally, including storage capacities, information technology (IT) resources, slide access requirements, plug-in software applications, system compatibilities, practice integration, regulatory agency ferences, aspects (ie, scanner qualities and times), and overall cost.47 Another significant obstacle has been pathologists' resistance to change and adaptation.48 Pathologists' emotions certainly impact their medical-related decisions.49 But although healthy skepticism is encouraged and essential in delivering efficient care and optimizing patient outcomes,50 pathologists' ever-increasing role in population health, precision medicine, and data aggregation calls for pathologists to embrace virtual diagnostic tools.51 These obstacles, however, are being increasingly overcome as more pathologists, especially new-in-practice pathologists, recognize and voice their preferences for the opportunities to practice in various hybrids of remote diagnostics. Numerous advantages counter these obstacles, including reliable data security (ie, glass slides can be lost or broken), easier slide access (ie, ability to sign out cases remotely), sharing of cases (eg, for second opinions, virtual teaching/education), research standardization, and implementing automated algorithms to improve diagnostic accuracy, time, and productivity.47 The US Food and Drug Administration approved the first WSI system in 2017 (Philips IntelliSite Pathology Solution) to allow pathologists to review and interpret digital slides \"prepared from biopsied tissue,\" and ensured that special controls (for WSI systems) \"must be met to assure..