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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.

Whole slide imaging is Food and Drug Administration-approved for primary diagnosis in the United States of America; however, relatively few pathology departments in the country have fully implemented an enterprise wide digital pathology system enabled for primary diagnosis. Digital pathology has significant potential to transform pathology practice with several published studies documenting some level of diagnostic equivalence between digital and conventional systems. However, whole slide imaging also has significant potential to disrupt pathology practice, due to the differences in efficiency of manipulating digital images vis-à-vis glass slides, and studies on the efficiency of actual digital pathology workload are lacking. Our randomized, equivalency and efficiency study aimed to replicate clinical workflow, comparing conventional microscopy to a complete digital pathology signout using whole slide images, evaluating the equivalency and efficiency of glass slide to whole slide image reporting, reflective of true pathology practice workloads in the clinical setting. All glass slides representing an entire day’s routine clinical signout workload for six different anatomic pathology subspecialties at Memorial Sloan Kettering Cancer Center were scanned on Leica Aperio AT2 at ×40 (0.25 µm/pixel). Integration of whole slide images for each accessioned case is through an interface between the Leica eSlide manager database and the laboratory information system, Cerner CoPathPlus. Pathologists utilized a standard institution computer workstation and viewed whole slide images through an internally developed, vendor agnostic whole slide image viewer, named the “MSK Slide Viewer”. Subspecialized pathologists first reported on glass slides from surgical pathology cases using routine clinical workflow. Glass slides were de-identified, scanned, and re-accessioned in the laboratory information system test environment. After a washout period of 13 weeks, pathologists reported the same clinical workload using whole slide image integrated within the laboratory information system. Intraobserver equivalency metrics included top-line diagnosis, margin status, lymphovascular and/or perineural invasion, pathology stage, and the need to order ancillary testing (i.e., recuts, immunohistochemistry). Turnaround time (efficiency) evaluation was defined by the start of each case when opened in the laboratory information system and when the case was completed for that day (i.e., case sent to signout queue or pending ancillary studies). Eight pathologists participated from the following subspecialties: bone and soft tissue, genitourinary, gastrointestinal, breast, gynecologic, and dermatopathology. Glass slides signouts comprised of 204 cases, encompassing 2091 glass slides; and digital signouts comprised of 199 cases, encompassing 2073 whole slide images. The median whole slide image file size was 1.54 GB; scan time/slide, 6 min 24 s; and scan area 32.1 × 18.52 mm. Overall diagnostic equivalency (e.g., top-line diagnosis) was 99.3% between digital and glass slide signout; however, signout using whole slide images showed a median overall 19% decrease in efficiency per case. No significant difference by reader, subspecialty, or specimen type was identified. Our experience is the most comprehensive study to date and shows high intraobserver whole slide image to glass slide equivalence in reporting of true clinical workflows and workloads. Efficiency needs to improve for digital pathology to gain more traction among pathologists.

Complete digital pathology and whole slide imaging for routine histopathology diagnosis is currently in use in few laboratories worldwide. Granada University Hospitals, Spain, which comprises 4 hospitals, adopted full digital pathology for primary histopathology diagnosis in 2016. To describe the methodology adopted and the resulting experience at Granada University Hospitals in transitioning to full digital diagnosis. All histopathology glass slides generated for routine diagnosis were digitized at ×40 using the Philips IntelliSite Pathology Solution, which includes an ultrafast scanner and an image management system. All hematoxylin-eosin-stained preparations and immunohistochemistry and histochemistry slides were digitized. The existing sample-tracking software and image management system were integrated to allow data interchange through the Health Level 7 protocol. Circa 160 000 specimens have been signed out using digital pathology for primary diagnosis. This comprises more than 800 000 digitized glass slides. The scanning error rate during the implementation phase was below 1.5%, and subsequent workflow optimization rendered this rate negligible. Since implementation, Granada University Hospitals pathologists have signed out 21% more cases per year on average. Digital pathology is an adequate medium for primary histopathology diagnosis. Successful digitization relies on existing sample tracking and integration of the information technology infrastructure. Rapid and reliable scanning at ×40 equivalent was key to the transition to a fully digital workflow. Digital pathology resulted in efficiency gains in the preanalytical and analytical phases, and created the basis for computational pathology: the use of computer-assisted tools to aid diagnosis.

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.

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.

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.

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 COVID-19 pandemic has challenged our diagnostic services at a time when many histopathology departments already faced a diminishing workforce and increasing workload. Digital pathology (DP) has been hailed as a potential solution to at least some of the challenges faced. We present a survey of pathologists within a UK National Health Service cellular pathology department with access to DP, in which we ascertain the role of DP in clinical services during this current pandemic and explore challenges encountered. This survey indicates an increase in uptake of diagnostic DP during this period, with increased remote access. Half of respondents agreed that DP had facilitated maintenance of diagnostic practice. While challenges have been encountered, these are remediable, and none have impacted on the uptake of DP during this period. We conclude that in our institution, DP has demonstrated current and future potential to increase resilience in diagnostic practice and have highlighted some of the challenges that need to be considered.

[...]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..