Digital Pathology Initiatives and Experience of a Large Academic Institution During the Coronavirus Disease 2019 (COVID-19) Pandemic.

CONTEXT.­: Pathology practices have begun integrating digital pathology tools into their routine workflow. During 2020, the coronavirus disease 2019 (COVID-19), caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), emerged as a pandemic, causing a global health crisis that significantly affected the world population in several areas, including medical practice, and pathology was no exception. OBJECTIVE.­: To summarize our experience in implementing digital pathology for remote primary diagnosis, education, and research during this pandemic. DESIGN.­: We surveyed our pathologists (all subspecialized) and trainees to gather information about their use of digital pathology tools before and during the pandemic. Quality assurance and slide distribution data were also examined. RESULTS.­: During the pandemic, the widespread use of digital tools in our institution allowed a smooth transition of most clinical and academic activities into remote with no major disruptions. The number of pathologists using whole slide imaging (WSI) for primary diagnosis increased from 20 (62.5%) to 29 (90.6%) of a total of 32 pathologists, excluding renal pathology and hematopathology, during the pandemic. Furthermore, the number of pathologists exclusively using whole slide imaging for primary diagnosis also increased from 2 (6.3%) to 5 (15.6%) during the pandemic. In 35 (100%) survey responses from attending pathologists, 21 (60%) reported using whole slide imaging for remote primary diagnosis following the Centers for Medicare and Medicaid Services waiver. Of these 21 pathologists, 18 (86%) responded that if allowed, they will continue using whole slide imaging for remote primary diagnosis after the pandemic. CONCLUSIONS.­: The pandemic served as a catalyst to pathologists adopting a digital workflow into their daily practice and realizing the logistic and technical advantages of such tools.

Digital pathology in the time of corona.

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.

Validation of a digital pathology system including remote review during the COVID-19 pandemic.

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: Technology and Applications.

Pathology has benefited from advanced innovation with novel technology to implement a digital solution. Whole slide imaging is a disruptive technology where glass slides are scanned to produce digital images. There have been significant advances in whole slide scanning hardware and software that have allowed for ready access of whole slide images. The digital images, or whole slide images, can be viewed comparable to glass slides in a microscope, as digital files. Whole slide imaging has increased in adoption among pathologists, pathology departments, and scientists for clinical, educational, and research initiatives. Worldwide usage of whole slide imaging has grown significantly. Pathology regulatory organizations (ie, College of American Pathologists) have put forth guidelines for clinical validation, and the US Food and Drug Administration have also approved whole slide imaging for primary diagnosis. This article will review the digital pathology ecosystem and discuss clinical and nonclinical applications of its use.

Use of a low-cost telecytopathology method for remote assessment of thyroid FNAs.

BACKGROUND: Rapid on-site evaluation is a great tool for optimizing the adequacy and quality of cytologic samples. The objective of the current study was to analyze a low-cost telecytopathology method for the remote assessment of thyroid fine-needle aspiration biopsies (FNABs), with comparison of the primarily rendered adequacy and diagnosis with the final conventional analysis. METHODS: Material collected from thyroid FNABs was immediately smeared onto glass slides and stained with Diff-Quik. A conventional microscope attached to a smart device was operated on-site by either a medical student or a pathology resident for Wi-Fi transmission of the images by Skype. The cytopathologist would remotely guide the screening of the slides, zooming in and out of areas of interest. Remote assessment included an analysis of material adequacy and a preliminary diagnosis. The quality of the transmission and the number of slides also were recorded. After a washout period of 3 weeks, final diagnosis and adequacy were assigned by conventional microscopy. RESULTS: The final agreement rate for adequacy between remote and conventional analysis was 90.5%. For diagnosis, the final agreement rate was 83.3%. The diagnosis agreement rate varied, depending on the quality of transmission: there was 88% agreement when the quality was excellent, 77.8% agreement when it was good, and 62.5% agreement when it was poor. CONCLUSIONS: Low-cost telecytopathology is an efficient method for the remote assessment of thyroid FNAB adequacy and diagnosis. The wide use of such technology in low-resource or remote centers may have a positive impact on the number of adequate or satisfactory samples, optimizing the management of patients who have thyroid nodules.

Telecytology: Is it possible with smartphone images?

INTRODUCTION: This study aimed to discuss smartphone usage in telecytology and determine intraobserver concordance between microscopic cytopathological diagnoses and diagnoses derived via static smartphone images. METHODS: The study was conducted with 172 cytologic material. A pathologist captured static images of the cytology slides from the ocular lens of a microscope using a smartphone. The images were transferred via WhatsApp® to a cytopathologist working in another center who made all the microscopic cytopathological diagnoses 5-27 months ago. The cytopathologist diagnosed images on a smartphone without knowledge of their previous microscopic diagnoses. The Kappa agreement between microscopic cytopathological diagnoses and smartphone image diagnoses was determined. RESULTS: The average image capturing, transfer, and remote cytopathological diagnostic time for one case was 6.20 minutes. The percentage of cases whose microscopic and smartphone image diagnoses were concordant was 84.30%, and the percentage of those whose diagnoses were discordant was 15.69%. The highest Kappa agreement was observed in endoscopic ultrasound-guided fine needle aspiration (1.000), and the lowest agreement was observed in urine cytology (0.665). Patient management changed with smart phone image diagnoses at 11.04%. CONCLUSIONS: This study showed that easy, fast, and high-quality image capturing and transfer is possible from cytology slides using smartphones. The intraobserver Kappa agreement between the microscopic cytopathological diagnoses and remote smartphone image diagnoses was high. It was found that remote diagnosis due to difficulties in telecytology might change patient management. The developments in the smartphone camera technology and transfer software make them efficient telepathology and telecytology tools.

The Pathologist 2.0: An Update on Digital Pathology in Veterinary Medicine.

Using light microscopy to describe the microarchitecture of normal and diseased tissues has changed very little since the middle of the 19th century. While the premise of histologic analysis remains intact, our relationship with the microscope is changing dramatically. Digital pathology offers new forms of visualization, and delivery of images is facilitated in unprecedented ways. This new technology can untether us entirely from our light microscopes, with many pathologists already performing their jobs using virtual microscopy. Several veterinary colleges have integrated virtual microscopy in their curriculum, and some diagnostic histopathology labs are switching to virtual microscopy as their main tool for the assessment of histologic specimens. Considering recent technical advancements of slide scanner and viewing software, digital pathology should now be considered a serious alternative to traditional light microscopy. This review therefore intends to give an overview of the current digital pathology technologies and their potential in all fields of veterinary pathology (ie, research, diagnostic service, and education). A future integration of digital pathology in the veterinary pathologist's workflow seems to be inevitable, and therefore it is proposed that trainees should be taught in digital pathology to keep up with the unavoidable digitization of the profession.

Design and Validation of a Low-Cost Telepathology System.

OBJECTIVE: This work sought to evaluate the precision and repeatability of a telepathology prototype based on open software and hardware. MATERIALS AND METHODS: A prototype was designed with application in telepathology and telemicroscopy. Accuracy and prototype precision were evaluated by calculating the mean absolute error and the intraclass and repeatability correlation coefficients for a series of 190 displacements at 10, 25, 50, 75, and 100 µm. RESULTS AND CONCLUSIONS: This work developed a low-cost prototype that is accessible, easily reproducible, implementable, and scalable; based on the use of technology created under principles of open software and hardware. A pathologist reviewed the obtained images and found them to be of diagnostic quality. Its excellent repeatability, coupled with its good accuracy, allows for its application in telemicroscopy and static, dynamic, and whole-slide imaging pathology systems.

Design of New Procedures for Diagnosing Prevalent Diseases Using a Low-Cost Telemicroscopy System.

BACKGROUND: Currently, the diagnosis of prevalent diseases such as malaria, tuberculosis, or diarrheal diseases in rural areas of developing countries requires the displacement of the patient from their community health post to their reference health center or to ship a sample. This delays diagnosis and the treatment of disease. OBJECTIVE: Conduct research to develop a new method for rapid low-cost diagnosis of prevalent diseases in rural areas of developing countries (malaria, tuberculosis, parasitic infections, vaginal infections, and cervical cancer). METHODS: The study was divided into three phases. The first related to the drafting and validating of new protocols for the preparation of samples that should be adapted to be carried out in areas without power and with little trained personnel. The second phase consisted of developing a telemicroscopy system looking for low cost, software compatibility, and technical quality. Finally, the third phase evaluated the system as a diagnostic tool using direct observation with a conventional microscope as the gold standard. RESULTS: The validation of the new protocols showed that 100% of the vaginal swabs were processed correctly when using direct smear, while they were only 86.3% correct when using Gram stain; 68.3% of fecal samples were correctly processed using Kinyoun stain; 61.7% of blood samples when using thin film; and 83.8% when using thick film. Phase 2 permitted the development of a low-cost (<$250) and low-power (<15 W) telemicroscopy system that allows real-time consultation between health technicians and specialists. Finally, phase 3 proved that there was no difference between the diagnostics obtained by direct observation in a microscope and those ones obtained through the new telemicroscopy system. CONCLUSIONS: This study has verified the effectiveness of the telemicroscopy system as a diagnostic tool, given the complete agreement between the diagnoses made with it and those made with the gold standard.

The Digital Microscopy in Organ Transplantation: Ergonomics of the Tele-Pathological Evaluation of Renal and Liver Grafts.

AIM: Ergonomics of Digital Microscopy (DM) based on virtual slides, on Telemedicine Systems (TS) for Tele-Pathological (TPE) evaluation of the grafts (G) in organ transplantation (OT). MATERIAL AND METHODS: Simulation of DM on TS based TPE by 2 specialists on a total of 238 human Renal Graft (RG) and 172 Liver Graft (LG) tissues digital microscopic images diagnosing inflammatory and neoplastic lesions on four different electronic spaces (ES). RESULTS: DM on TS for TPE in OT is elaborated perfectly on the ES of a Desktop, followed by the ES of the applied Exp.-TS. Tablet and Mobile-Phone ES seem significantly risky for the application of DM in OT (p<.001). CONCLUSION: Integration of DM on TS for TPE is feasible, while ergonomics of post-grafting and pre-transplant decision support and planning depend on the size of the working ES.

Validation of multiple whole slide imaging scanners based on the guideline from the College of American Pathologists Pathology and Laboratory Quality Center.

CONTEXT: Whole slide imaging (WSI) produces a virtual image that can be transmitted electronically. This technology has clinical applications in situations in which glass slides are not readily available. OBJECTIVE: To examine the results of a validation study performed using the draft version of the WSI clinical validation guideline recently released by the College of American Pathologists. DESIGN: Ten iScan Coreo Au scanners (Ventana Medical Systems, Tucson, Arizona) were validated, 6 with one set of 100 cases and 4 with a different set of 100 cases, for 1000 case examinations. The cases were selected consecutively from the following case types: internal consultations and malignancies and cases with frozen sections, special stains, and/or immunohistochemistry. Only key slides were scanned from each case. The slides were scanned at ×20 magnification. Pathologists reviewed the cases as both glass slides and WSI, with at least a 3-week washout period between viewings. RESULTS: Intraobserver agreement between glass slides and WSI was present for 786 (79%) of the 1000 cases. Major discrepancies occurred in 18 cases (1.8%). κ statistics compiled for the subset of cases (n = 504; 50%) with concern for neoplasia showed excellent agreement (κ = 0.8782). Individual scanners performed similarly to one another. Analysis of the results revealed an area of concern: small focal findings. CONCLUSIONS: The results were felt to validate the use of WSI for the intended applications in our multiinstitutional laboratory system, although scans at ×20 magnification may be insufficient for cases hinging on small focal findings, such as microorganisms and inflammatory processes.

Los orígenes caribeños del Sistema Nacional de Salud Pública en los EEUU: una aproximación global a la historia de la medicina y de la salud pública en Latinoamérica / The Caribbean origins of the National Public Health System in the USA: a global approach to the history of medicine and public health in Latin America

Este artículo define la historia global en relación con historia de la medicina y la salud pública. Defiende que una aproximación global a la historia abre un espacio para reverberaciones transmitidas desde la periferia geográfica hacia regiones occidentales, las cuales, tradicionalmente, han dominado la historiografía moderna. Analiza dos intervenciones médicas, en el Caribe, a finales del siglo XIX y principios del XX, y señala que estos sucesos tuvieron profundas consecuencias en los EEUU. Los logros alcanzados en el Caribe, en lo relativo al control de la fiebre amarilla y del anquilostoma, además de servir de modelo para campañas sanitarias en el sur de los EEUU, impulsaron la centralización de la salud pública norteamericana bajo el control centralizador del gobierno federal.

This article defines global history in relation to the history of medicine and public health. It argues that a global approach to history opens up a space for examining the reverberations transmitted from the geographic periphery towards western regions, which have traditionally dominated modern historiography. It analyzes two medical interventions in the Caribbean in the late nineteenth and early twentieth century, showing how these events had profound consequences in the USA. The successes achieved in the Caribbean in terms of yellow fever and ancylostoma control, as well as providing a model for health campaigns in the southern USA, inspired the centralization of public health in North America under the centralizing control of the federal government.

Mobile teledermatology is a valid method to estimate prevalence of melanocytic naevi in children.

The prevalence of melanocytic naevi in children correlates with sun exposure and may serve as an objective population risk indicator of future melanoma incidence. The aim was to investigate if mobile teledermatology could offer a valid methodology compared with standard manual, face-to-face counting of naevi on the back of children. Ninety-seven children aged 7-16 years were enrolled. One dermatologist performed manual naevi counting and imaging of the child's back using an iPhone 4S comprising a safe-coded mobile application. Two other dermatologists independently counted naevi from the images. Cohen's weighted kappa (κw) coefficient demonstrated substantial agreement for both dermatologists: κw = 0.69 (0.57-0.81 [95% confidence intervals]) and κw = 0.78 (0.70-0.86), compared with the manual assessment. Inter-rater reliability was also substantial (κw = 0.80 [0.73-0.87]). Use of mobile teledermatology proved valid for estimating naevi prevalence on the back and could provide a more feasible methodology following trends in sun exposure in children.

Smartphone teledermoscopy referrals: a novel process for improved triage of skin cancer patients.

In this open, controlled, multicentre and prospective observational study, smartphone teledermoscopy referrals were sent from 20 primary healthcare centres to 2 dermatology departments for triage of skin lesions of concern using a smartphone application and a compatible digital dermoscope. The outcome for 816 patients referred via smartphone teledermoscopy was compared with 746 patients referred via the traditional paper-based system. When surgical treatment was required, the waiting time was significantly shorter using teledermoscopy for patients with melanoma, melanoma in situ, squamous cell carcinoma, squamous cell carcinoma in situ and basal cell carcinoma. Triage decisions were also more reliable with teledermoscopy and over 40% of the teledermoscopy patients could potentially have avoided face-to-face visits. Only 4 teledermoscopy referrals (0.4%) had to be excluded due to poor image quality. Smartphone teledermoscopy referrals allow for faster and more efficient management of patients with skin cancer as compared to traditional paper referrals.

Concordance and time estimation of store-and-forward mobile teledermatology compared to classical face-to-face consultation.

Smartphones have overcome the limitations of image quality seen in older devices and opened a new field of telemedicine called "mobile teledermatology". Technological advances and the need to reduce health service costs will strongly promote the development of telemedicine. For this reason, we evaluated the concordance between store-and-forward mobile teledermatology and the classical face-to-face dermatological visit. We also measured the time taken to submit a teleconsultation using a smartphone. Before conventional face-to-face visit, a final-year resident of the three-year course for general practitioners collected medical history, took digital images of skin diseases with a smartphone and, measuring the time required to complete this operation, transmitted them to an expert teledermatologist. In 391 patients we obtained a concordance between face-to-face and store-and-forward diagnosis of 91.05% (Cohen κ coefficient = 0.906). On average only few minutes needs to be added to a normal visit to transmit the cases to an expert teledermatologist.

Internal validation testing for new technologies: bringing telecytopathology into the mainstream.

Implementing new technology in the laboratory can improve processes and patient care, but compliance with regulatory requirements can be a significant hurdle to clear. This study provides a detailed procedure to address user training, competency assessment, and internal validation of telecytopathology simultaneously, while fulfilling regulatory requirements set forth by the College of American Pathologists and CLIA '88. Six pathologists participated in this study. Methods and materials used included a blind correlation study between diagnoses rendered via telecytopathology and via direct microscopy on 10 finalized fine needle aspiration (FNA) cases. The first step of this procedure involved each pathologist to render a diagnosis for each specimen using telecytopathology. The second step was to allow each pathologist to diagnose each specimen via direct microscopic review after a wait period of at least 6 weeks. The diagnoses rendered via telecytopathology were then compared to both the established final diagnoses and the secondary direct microscopic review diagnoses to examine interpathologist and intrapathologist reproducibility with a passing rate of 90% or better. Results of the study yielded an average concordance rate of 96.67% for interpathologist reproducibility and 95% for intrapathologist reproducibility across all participating pathologists. All participants passed the assessment with a rate of 90% or better, proving evidence of competency. This study confirmed user competency and validated telecytopathology as an effective tool for examining and diagnosing cytology FNA specimens remotely. It also satisfied regulatory compliance requirements to ensure high quality of diagnostic testing and patient care.