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: Clinical Workflows and Primary Diagnosis.

Digital pathology has made great strides in recent years culminating with the approval to market devices from the Food and Drug Administration. The pathology community is now poised to begin using these systems for diagnostic purposes. This article will discuss the preparatory steps needed to implement digital pathology as well as some implementation styles that may be sufficient for a pathology department.

Pathologist Opinions about EPIC Beaker AP: a Multi-Institutional Survey of Early Adopters.

EPIC Systems Corporation provides a widely used electronic medical record. Beaker Anatomic Pathology is a newly developed laboratory information system (LIS) that has been implemented at a small number of academic pathology departments. Pathologist opinions of EPIC Beaker AP have not been well described in the literature. A 37-question survey was administered to pathologists and pathology trainees to assess overall satisfaction and efficiency of report generation using Beaker AP. Data about experience in pathology, signout responsibilities, Beaker AP usage, and the legacy LIS was also collected. Seventy-four pathologists (51 faculty, 23 residents) responded to the survey (overall response rate 29.7%). Overall pathologist satisfaction with Beaker AP showed high inter-institutional variability; institutions with legacy LISs with a graphical interface had a generally neutral to negative assessment of Beaker AP. The majority of respondents disagreed with the statement "Beaker AP is easy to use and designed for my needs". Pathologists felt that Beaker AP was useful for reviewing clinical information and billing; areas of weakness included searching for prior cases and grossing efficiency. Overall, pathologists had a neutral opinion of whether generating and signing out a complete report was faster in Beaker AP, with marked inter-institutional variation. This variability was likely due to a combination of the efficacy of the legacy LIS, familiarity with Beaker AP at the time of the survey, and institution-specific optimization efforts.

The Influence of Telepathology on Coordination Practices.

BACKGROUND: Coordination between physicians and allied professionals is essential to the effective delivery of care services and is associated with positive patient outcomes. As information technology can radically transform how professionals collaborate, both researchers and healthcare accreditation bodies are devoting a growing interest to the means of achieving better coordination. INTRODUCTION: The primary aim of this study is to explain the extent to which and how coordination practices between pathologists, technologists, and surgeons are transformed when telepathology is being implemented. MATERIALS AND METHODS: An interpretive case study was conducted. A total of 60 semistructured interviews with key participants were conducted, in addition to several days of direct observation of telepathology-based intraoperative consultations (IOCs). RESULTS: Three major kinds of transformation of coordination practices were observed. First, the telepathology system itself constrains and disrupts coordination routines, such as the presentation of slides. Second, anticipating IOC, proactively performed by the laboratory personnel in traditional settings, requires more formal requests in a telepathology context. Third, local technologists become more autonomous in performing complex macroscopy manipulations and managing the laboratory tasks traditionally performed by pathologists. CONCLUSIONS: Successful coordination of work in a telepathology-based IOC context requires that significant transformations be anticipated and accounted for. Project managers need to formalize new work processes, support the transformations in professional roles, and mitigate the major hindrances that small material changes may have on work routines.

The Empirical Foundations of Telepathology: Evidence of Feasibility and Intermediate Effects.

INTRODUCTION: Telepathology evolved from video microscopy (i.e., "television microscopy") research in the early 1950s to video microscopy used in basic research in the biological sciences to a basic diagnostic tool in telemedicine clinical applications. Its genesis can be traced to pioneering feasibility studies regarding the importance of color and other image-based parameters for rendering diagnoses and a series of studies assessing concordance of virtual slide and light microscopy diagnoses. This article documents the empirical foundations of telepathology. METHODS: A selective review of the research literature during the past decade (2005-2016) was conducted using robust research design and adequate sample size as criteria for inclusion. CONCLUSIONS: The evidence regarding feasibility/acceptance of telepathology and related information technology applications has been well documented for several decades. The majority of evidentiary studies focused on intermediate outcomes, as indicated by comparability between telepathology and conventional light microscopy. A consistent trend of concordance between the two modalities was observed in terms of diagnostic accuracy and reliability. Additional benefits include use of telepathology and whole slide imaging for teaching, research, and outreach to resource-limited countries. Challenges still exist, however, in terms of use of telepathology as an effective diagnostic modality in clinical practice.

The Use of Telehealth to Reduce Inequalities in Cardiovascular Outcomes in Australia and New Zealand: A Critical Review.

Telehealth, the delivery of health care services at a distance using information and communications technology, is one means of redressing inequalities in cardiovascular outcomes for disadvantaged groups in Australia. This critical review argues that there is sufficient evidence to move to larger-scale implementation of telehealth for acute cardiac, acute stroke, and cardiac rehabilitation services. For cardiovascular chronic disease and risk factor management, telehealth-based services can deliver value but the evidence is less compelling, as the outcomes of these programs are variable and depend upon the context of their implementation.

Impacts of a Large Decentralized Telepathology Network in Canada.

BACKGROUND: Telepathology is a fast growing segment of the telemedicine field. As of yet, no prior research has investigated the impacts of large decentralized telepathology projects on patients, clinicians, and healthcare systems. This study aims to fill this gap. We report a benefits evaluation study of a large decentralized telepathology project deployed in Eastern Quebec, Canada whose main objective is to provide continuous coverage of intraoperative consultations in remote hospitals without pathologists on-site. The project involves 18 hospitals, making it one of the largest telepathology networks in the world. MATERIALS AND METHODS: We conducted 43 semistructured interviews with several telepathology users and hospital managers. Archival data on the impacts of the telepathology project (e.g., number of service disruptions, average time between initial diagnosis and surgery) were also extracted and analyzed. RESULTS: Our findings show that no service disruptions were recorded in hospitals without pathologists following the deployment of telepathology. Surgeons noted that the use of intraoperative consultations enabled by telepathology helped avoid second surgeries and improved accessibility to care services. Telepathology was also perceived by our respondents as having positive impacts on the remote hospitals' ability to retain and recruit surgeons. CONCLUSIONS: The observed benefits should not leave the impression that implementing telepathology is a trivial matter. Indeed, many technical, human, and organizational challenges may be encountered. Telepathology can be highly useful in regional hospitals that do not have a pathologist on-site. More research is needed to investigate the challenges and benefits associated with large decentralized telepathology networks.

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.

Telepathology in cytopathology: challenges and opportunities.

OBJECTIVE: Telepathology in cytopathology is becoming more commonly utilized, and newer technologic infrastructures afford the laboratory a variety of options. The options and design of a telepathology system are driven by the clinical needs. This is primarily focused on providing rapid on-site evaluation service for fine needle aspiration. STUDY DESIGN: The clinical requirements and needs of a system are described. Available tools to design and implement a telepathology system are covered, including methods of image capture, network connectivity and remote viewing options. RESULTS: The primary telepathology method currently used and described involves the delivery via a network connection of a live video image to a remote site which is passively viewed by an internet web-based browser. By utilizing live video information and a voice connection to the on-site location, the remote viewer can collect clinical information and direct their view of the slides. CONCLUSIONS: Telepathology systems for use in cytopathology can be designed and implemented with commercially available infrastructure. It is necessary for the laboratory to validate the designed system and adhere to the required regulatory requirements. Telepathology for cytopathology can be reliably utilized by adapting existing technology, and newer advances hold great promise for further applications in the cytopathology laboratory.

The effects of a regional telepathology project: a study protocol.

BACKGROUND: Telepathology, which is an emerging form of telemedicine in Canada, is defined as the electronic transmission of pathological images, usually derived from microscopes, from one location to another. There are various applications of telepathology, including case referral for an expert opinion, provision of an emergency service in the absence of a resident pathologist, and education. Until now, there has been relatively little use of telepathology for core diagnostic services in the absence of a local pathologist, but this practice is likely to increase in the future. The Laval University Integrated Health Network is in the process of deploying a telepathology system, primarily to provide an intraoperative frozen section service to small hospitals in sparsely populated areas which are experiencing a severe shortage of on-site pathologists. The telepathology project involves 17 hospitals located in five regions of eastern Quebec, Canada. This paper describes the study protocol that will be used to evaluate the benefits associated with the project. METHODS/DESIGN: A panel of experts was first assembled by Canada Health Infoway to agree on a set of benefits indicators that could be applied to all telepathology projects across Canada. Using the set of indicators as an input, we have developed a three-step study protocol. First, a survey questionnaire will be distributed to appraise the way pathologists, pathology technologists and surgeons perceive the telepathology system and its impacts. Second, a series of semi-structured interviews will be conducted with project leaders and telepathology users at sites that are representative of all the hospitals in the Laval University Integrated Health Network. The overall aim is to better understand the expected and unexpected effects of telepathology on health care professionals and patients as well as on the regional organization and delivery of care services. Finally, a pre-post design using secondary data is proposed to evaluate a wide array of tangible benefits to the patients, the health care providers, the hospitals, and the region as a whole. DISCUSSION: The Laval University Integrated Health Network's telepathology project is expected to yield positive and significant results that are relevant internationally. Our findings will provide valuable information on the nature and extent of benefits associated with telepathology systems intended to provide an intraoperative frozen section service to remote hospitals experiencing a shortage of specialists.

[The Eastern Quebec telepathology network: a real collective project]. / Le réseau de télépathologie de l'Est du Québec - Un véritable projet collectif.

The aim of the Eastern Québec telepathology network is to provide uniform diagnostic telepathology services across a huge geographic region with a low population density. This project is intended to provide surgeons and pathologists with frozen section and second opinion services anywhere and at any time across the entire region, in order to avoid unnecessary patient transfer. The project has been implemented in 21 sites, each equipped with a whole slide scanner, a macroscopy station, a videoconferencing device and a viewer/case management and collaboration solution. Of the 21 sites, 6 are devoid of a pathology laboratory, two have no pathologist and 5 have only one pathologist on site. Signs of improvement of medical care in this region are already apparent since the Eastern Québec telepathology network has been implemented. However, it is important not to underestimate the challenges related to change management in the course of implementation of such a new technology.

Paradigm changes in health lead to paradigm changes in pathology.

For the sake of safety and quality of care as well as efficiency of care processes, health systems undergo a paradigm change towards personalized, ubiquitous, health services. This change includes preventive and predictive medicine based on advanced translational medicine. Here we introduce domain-specific, organizational, and technical paradigms, requirements and solutions for personalized, ubiquitous, care. Emphasizing the formal aspects of modeling and implementing Telehealth and personal health (pHealth) interoperability and the entailed multidisciplinary integration, and illustrate the drivers behind and benefits of personalized medicine with a specific focus on the changing trends and impact on pathology, especially emphasizing Telepathology.

Telepathology interoperability - a system architectural approach.

eHealth and pHealth, instantiated, e.g., in telepathology solutions, have to meet advanced interoperability challenges. Technologically supported by pervasive computing and even autonomic computing, pHealth covers many domains, scientifically managed by specialized disciplines using their specific ontologies. Therefore, semantic interoperability has to advance from a communication protocol to knowledge coordination and sharing, deploying advanced system architectures. Based on long-term work of scientific institutions and SDOs dedicated to system architectures, an interoperability framework is presented, integrating existing, emerging and even future specifications and standards for comprehensive interoperability of health and social services. The methodology is proven in many health information systems implementation and standard developments projects.

Security and privacy services in pathology for enabling trustworthy personal health.

Ubiquitous personalized health services including ePathology require comprehensive, but trusted interoperability. Contrary to regulated traditional health services with pre-defined policies, the solutions enabled by mobile, pervasive and autonomous technology have to follow dynamic policies reflecting the customers changing health services needs, expectations and wishes as well as contextual and environmental conditions. The paper introduces an advanced approach to trustworthy architecture-centric, policy-driven pHealth solutions. To some details, it also addresses security and privacy ontologies to represent the required policies.

[Telepathology in Uzbekistan].

Since 2003, a system of teleconsultations by the specialists of regional postmortem bureaus (RPB) in various areas of pathology has been stepwisely set up on the basis of the Republican Postmortem Center in Uzbekistan. Each of 13 RPBs has at its disposal microscopes with digital photo and television cameras, and a fast-acting internet to transmit microscopic images of difficult cancer biopsies and autopsies, including cases of maternal deaths. The local specialists transmit these data to the Republican Postmortem Center (Tashkent). Such verified biopsies were more than 8000 in late 2008. The introduction of new information technologies in Uzbekistan has allowed a number of essential, organizational diagnostic problems to be solved.

Establishment of a remote diagnostic histopathology service using whole slide imaging (digital pathology).

BACKGROUND: Whole slide imaging (WSI) has diverse applications in modern pathology practice, including providing histopathology services to remote locations. MATERIALS AND METHODS: Utilising an existing contractual partnership with a Northern Ontario group of hospitals, the feasibility of using WSI for primary diagnostic services from Toronto was explored by the dedicated working group. All aspects explored from information technology (IT), laboratory information system (LIS) integration, scanning needs, laboratory workflow and pathologist needs and training, were taken into account in the developing the rationale and business case. RESULTS: The financial outlay for a scanner was $CA180K (approximately £105.6 k) after discounts. There were no human resource requirements as staff were reorganised to cater for slide scanning. Additional IT/LIS costs were not incurred as existing connectivity was adapted to allow two site groups (gastrointestinal and skin) to pilot this study. Scanned slides were available for pathologist review 24-96 hours sooner than glass slides; there was a 2-day improvement for final authorised cases, and per annum savings were: $CA26 000 (£15.2 k) in courier costs, $CA60 000 (£35.2 k) travel and $CA45 000 (£26.4 k) in accommodation, meals and car rental expense. CONCLUSION: WSI is a viable solution to provide timely, high-quality and cost efficient histopathology services to underserviced, remote areas.

Implementation and assessment of a telecytology quality assurance program.

INTRODUCTION: The College of American Pathologists mandates that telepathology services are included in laboratory quality management programs. The aim of this study was to assess a telecytology quality assurance (QA) process that we implemented in 2015. MATERIALS AND METHODS: Each month, a cytotechnologist randomly selected 3 telecytology fine-needle aspiration (FNA) cases from each cytopathologist on the FNA service that month. Data were recorded in a monthly worksheet and included onsite telecytology adequacy, final adequacy, concordance, onsite operator, cytopathologist, and reason for discrepancy, if present. The worksheet was reviewed monthly, discordant cases were re-examined, and feedback to cytologists was provided. For this study, worksheets from October 2015 to December 2019 were retrospectively reviewed. RESULTS: The QA program captured 488 cases, representing 25% of total cases that utilized telecytology during the evaluation period (n = 1983). The telecytology onsite assessment was concordant with the final cytologic assessment in 84% (410 of 488) of cases. The majority of discordant cases (72 of 78, 92%) were the result of an "Inadequate" onsite telecytology assessment, but a final diagnosis was able to be rendered; 92% of these cases were attributed to diagnostic material being present in cytologic preparations not available during the onsite assessment. Nine telecytology onsite interpretation errors were identified, of which 7 were provided by cytopathologists with less than 2 years of experience. CONCLUSIONS: Most telecytology cases with onsite assessment errors were evaluated by cytopathologists with less than 2 years of practice experience; therefore, careful monitoring of new staff should be considered when developing a telecytology QA program.

Application of medical information system for telepathology--Georgian experience.

INTRODUCTION: The field of healthcare informatics is rapidly evolving. The new models and protocols of medical information system (MIS) are developed. Despite obvious advantages and benefits, practical application of MIS in everyday practice is slow. Much progress has been made around the world in the field of digital imaging and virtual slides, but in Georgia telepathology is still in evolving stages. It revolves around static telepathology. OBJECTIVE: Practical application of MIS has been started in Georgia. The architecture of the mentioned system and its usage for telepathology will be presented. MATERIALS AND METHODS: The MIS has been created with .Net technology and structure query language (SQL) database architecture. It involves a multiuser Web-based approach. By this, local (intranet) and remote (Internet) access of the system and management of databases can be achieved. Two hundred electronic medical records illustrated by images were selected for telepathology consultations. These electronic medical records were written in Georgian. This predetermines organization of regional second opinion consultations. For security reasons all experts have been registered as users at MIS. RESULTS: MIS has been launched in Georgia. Its primary goal is patient management. However, the system can be successfully applied for static telepathology purposes. DISCUSSION: The ideal of healthcare in the information age must be to create a situation where healthcare professionals spend more time creating knowledge from medical information and less time managing medical information. The application of easily available and adaptable technology and improvement of the infrastructure conditions is the basis for telemedical applications. The usage of MIS holds the potential to realize telepathology in the effective and comprehensive mode.

Experience with telepathology in combination with diagnostic assistance systems in countries with restricted resources.

INTRODUCTION: We describe the use of telepathology in countries with restricted resources using two diagnosis assistance systems (Isabel and Memem7) in addition to the diagnoses made by experts in pathology via the iPath-Network. METHODS: A total of 156 cases, largely from Afghanistan, were analysed; 18 cases had to be excluded because of poor image quality. RESULTS: Of the remaining 138 cases (100%), a responsible physician provided a tentative diagnosis for 61.6% of them. With a diagnosis from a consultant pathologist, it was then possible to make a definite diagnosis in 84.8% of cases on the basis of images taken from hematoxylin and eosin staining sections alone. The use of the diagnosis assistance systems resulted in an ordered list of differential diagnoses in 82.6% (IsabelHealth) and in 74.6% (Memem7) of cases, respectively. Adding morphological terminology reduced the list of possible diagnoses to 52.2% (72 cases, Memem7), but improved their quality. DISCUSSION: In summary, diagnosis assistance systems are promising approaches to provide physicians in countries with restricted resources with lists of probable differential diagnoses, thus increasing the plausibility of the diagnosis of the consultant pathologist.

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.