Fifty years of impact on liver pathology: a history of the Gnomes.

Professional societies play a major role in medicine and science. The societies tend to be large with well-developed administrative structures. An additional model, however, is based on small groups of experts who meet regularly in an egalitarian model in order to discuss disease-specific scientific and medical problems. In order to illustrate the effectiveness of this model, the history and practices are examined of a long-standing successful example, the International Liver Pathology Group, better known as the Gnomes. The history shows that groups such as the Gnomes offer a number of important benefits not available in larger societies and nurturing such groups advances science and medicine in meaningful ways. The success of the Gnomes' approach provides a road map for future small scientific groups.

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.

Strengthening Laboratory Diagnostic Capacity to Support Cancer Care in Uganda.

OBJECTIVES: An accurate cancer diagnosis is critical to providing quality care to patients with cancer. We describe the results of a laboratory improvement process that started in 2017 to improve access to cancer diagnostics at the Uganda Cancer Institute (UCI). The overall objective of the project was to build capacity for the provision of quality and timely laboratory diagnostics to support cancer care in Uganda. METHODS: A phased multistep approach was used to improve laboratory capacity, including staff training, additional staff recruitment, equipment overhaul, and optimization of the supply chain. RESULTS: The program led to the establishment of a pathology laboratory that handled 5,700 tissue diagnoses in 2019. Immunohistochemistry services are now offered routinely. Turnaround time for histopathology has also reduced from an average of 7 to 14 days to 5.4 days. The main clinical laboratory has also increased both the test volume and the test capacity, with the additional establishment of a molecular diagnostics laboratory. CONCLUSIONS: Our project shows a pathway to the improvement of laboratory diagnostic capacity in cancer care centers in sub-Saharan Africa (SSA). Improved laboratory diagnostic capacity is critical to improving cancer care in SSA and more rational use of targeted therapies.

Using Timestamp Data to Assess the Impact of Voice Recognition on the Efficiency of Grossing Biopsies.

CONTEXT.­: Studies on the adoption of voice recognition in health care have mostly focused on turnaround time and error rate, with less attention paid to the impact on the efficiency of the providers. OBJECTIVE.­: To study the impact of voice recognition on the efficiency of grossing biopsy specimens. DESIGN.­: Timestamps corresponding to barcode scanning for biopsy specimen bottles and cassettes were retrieved from the pathology information system database. The time elapsed between scanning a specimen bottle and the corresponding first cassette was the length of time spent on the gross processing of that specimen and is designated as the specimen time. For the first specimen of a case, the specimen time additionally included the time spent on dictating the clinical information. Therefore, the specimen times were divided into the following 2 categories: first-specimen time and subsequent-specimen time. The impact of voice recognition on specimen times was studied using both univariate and multivariate analyses. RESULTS.­: Specimen complexity, prosector variability, length of clinical information text, and the number of biopsies the prosector grossed that day were the major determinants of specimen times. Adopting voice recognition had a negligible impact on specimen times. CONCLUSIONS.­: Adopting voice recognition in the gross room removes the need to hire transcriptionists without negatively impacting the efficiency of the prosectors, resulting in an overall cost saving. Using computer scripting to automatically enter clinical information (received through the electronic order interface) into report templates may potentially increase the grossing efficiency in the future.

Impact of the COVID-19 pandemic on cytology practice: An international survey in the Asia-Pacific region.

BACKGROUND: The purpose of the current study was to examine the impact of coronavirus disease 2019 (COVID-19) on various aspects of cytology practice in the Asia-Pacific region. METHODS: An online questionnaire was distributed to cytopathology laboratories in 24 Asia-Pacific countries to explore the impact of restrictive measures on access to health care, use of general and personal protective equipment (PPE), and changes in cytology workflow and workload from February to April 2020. RESULTS: A total of 167 cytopathology laboratories from 24 countries responded to the survey; the majority reported that restrictive measures that limited the accessibility of health care services had been implemented in their cities and/or countries (80.8%) and their hospitals (83.8%). The respondents noted that COVID-19 had an impact on the cytologic workflow as well as the workload. Approximately one-half of the participants reported the implementation of new biosafety protocols (54.5%) as well as improvements in laboratory facilities (47.3%). Rearrangement or redeployment of the workforce was reported in 53.3% and 34.1% of laboratories, respectively. The majority of the respondents reported a significant reduction (>10%) in caseload associated with both gynecological (82.0%) and nongynecological specimens (78.4%). Most laboratories reported no significant change in the malignancy rates of both gynecological (67.7%) and nongynecological specimens (58.7%) compared with the same period in 2019. CONCLUSIONS: The results of the survey demonstrated that the COVID-19 pandemic resulted in a significant reduction in the number of cytology specimens examined along with the need to implement new biosafety protocols. These findings underscore the need for the worldwide standardization of biosafety protocols and cytology practice.

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.

Institutional Training Opportunities for PhD Students in Laboratory Medicine: An Unmet Career Development Need?

In the United States, the credentialing of PhD-scientists as medical directors of clinical laboratories is driven by formal postdoctoral training programs. Prior to acceptance in one these accredited fellowships, however, a trainee's exposure to the field can be far less standardized, with significant ramifications for their awareness and competitiveness. In the current article, we describe our recent experiences in developing local, institution-based immersion opportunities for PhD experiences in the subdisciplines of laboratory medicine (clinical microbiology, clinical chemistry, and molecular genetics/genomics). It is our hope that this article-and a corresponding online survey-can prompt reflection and discussion on the status of early career training opportunities in these key clinical areas.

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.

Maintaining quality diagnosis with digital pathology: a practical guide to ISO 15189 accreditation.

An ever-increasing number of clinical pathology departments are deploying, or planning to deploy digital pathology systems for all, or part of their diagnostic output. Digital pathology is an evolving technology, and it is important that departments uphold or improve on current standards. Leeds Teaching Hospitals NHS Trust has been scanning 100% of histology slides since September 2018, and has developed validation and validation protocols to train 38 histopathology consultants in primary digital diagnosis. In this practical paper, we will share our approach to ISO inspection of our digital pathology service, which resulted in successful ISO accreditation for primary digital diagnosis. We will offer practical advice on what types of procedure and documentation are necessary, both from the point of view of the laboratory and your reporting pathologists. We will explore topics including risk assessment, standard operating procedures, validation and training, calibration and quality assurance, and provide a checklist of the key digital pathology components you need to consider in your inspection preparations. The continuous quest for quality and safety improvements in our practice should underpin everything we do in pathology, including our digital pathology operations. We hope this publication will make it easier for subsequent departments to successfully achieve ISO 15189 accreditation and feel confident in their digital pathology services.

Data warehouse strategies and the modern anatomic pathology laboratory: Quality management, patient safety, and pathology productivity issues and opportunities.

Application of lean process management strategies to process improvement in clinical and anatomic pathology laboratories afford opportunities to enhance workflow process to lower costs and simultaneously to improve patient safety. Bar-codes are now employed in most modern anatomic pathology laboratories to track specimens from the clinicians' office or the operating room all through the continuum of service to specimen disposal. In order to enhance patient safety and workload optimization strategies, novel computer hardware and software assets are being developed to enable monitoring, analysis, and improvement of specimen workflow and diagnostic accuracy. More recently, data warehouse technologies from the retail industry have been optimized to permit high-throughput analysis of granular data in the laboratory arena. These optimize mass-data analysis in real time in the information technology space. In this review we describe the application of an in-house designed data warehouse to the anatomic pathology assets of a large regional reference laboratory.

PD-L1 expression on routine samples of non-small cell lung cancer: results and critical issues from a 1-year experience of a centralised laboratory.

AIMS: Our laboratory is a centralised centre receiving routine non-small cell lung cancer (NSCLC) samples for programmed death ligand-1 (PD-L1) immunohistochemical (IHC) evaluation. Since literature data are not concordant here we review our clinical records to assess the rate of PD-L1 positive and negative NSCLC cases in real-world practice. METHODS: PD-L1 expression was evaluated by a validated 22C3 IHC laboratory developed test on 211 prospectively collected routine NSCLC samples, received from 10 outside institutions. PD-L1 expression was assessed by the tumour proportion score (TPS) and reported by using a three cut-point system: TPS<1, TPS 1%-49% and TPS≥50%. RESULTS: Overall, 193 out of 211 samples (91.5%) meet the criteria for adequacy (more than 100 viable neoplastic cells). In 62.7% (121/193) of samples TPS was <1%; 17.6% of samples (34/193) expressed PD-L1 with a TPS of 1%-49% and 19.7% (38/193) with a TPS of >50%. There was no significant difference in PD-L1 expression rates between different histotypes and site of sampling. Instead, a statistically significant difference was associated to the type of samples: in fact, cytological samples were more frequently negative for PD-L1 expression (TPS<1%) and less often displayed PD-L1 expression at high levels (TPS>50%) than surgical resections and biopsies. CONCLUSIONS: We present a referral laboratory experience on IHC PD-L1 expression of prospectively collected routine NSCLC samples. Data from the real-world practice can better clarify the percentage of PD-L1 positive and negative cases, to establish benchmarks for good practice standards.

Digital immunohistochemistry implementation, training and validation: experience and technical notes from a large clinical laboratory.

AIMS: To consider the value proposition of digitisation of clinical immunohistochemistry services, and to develop an approach to digital immunohistochemistry implementation and validation in a large clinical laboratory. METHODS: A methodology for slide scanning in the laboratory was developed, in addition to a novel validation exercise, to allow pathologists to identify the strengths and weaknesses of digital immunohistochemistry reporting, and train in digital immunohistochemistry slide assessment. RESULTS: A total of 1480 digital immunohistochemistry slides were assessed by 24 consultant pathologists, with complete clinical concordance between the digital and the glass slide assessment observed. Certain stains were identified as being difficult/time consuming to assess using ×20 digital slides. These stains were rescanned at ×40, which improved the confidence of the pathologists to make a digital assessment. Full digitisation of immunohistochemistry slides was achieved, introducing six new steps into the pre-existing laboratory workflow. CONCLUSIONS: While initially encountering challenges in terms of workflow, our experience showed that a well-designed, adequately resourced and well-managed scanning process can minimise the delay in slides being made available for review. Our approach to validation highlighted the need for careful assessment of a digital pathology system and scanning protocols before pathologists are expected to transfer from the light microscope to the digital microscope for routine immunohistochemistry assessment.

Consolidation of pathology services in England: have savings been achieved?

BACKGROUND: During the last decade, pathology services in England have undergone profound changes with an extensive consolidation of laboratories. This has been driven by some national reviews forecasting a national reduction of costs by £250-£500 million ($315-$630 million) a year as a result. The main aim of this paper is to describe the financial impact of such consolidation, with a specific focus on the forecasted savings. A secondary aim is to describe the development of private sector involvement in laboratory services in a traditionally publicly funded healthcare system and the development of pathology staff size. METHODS: In the English scenario, the majority of hospitals and laboratories are publicly funded and a survey was sent as Freedom of Information request to all directors of pathology. A descriptive comparison of savings among consolidated and non-consolidated pathology services was made by using the pathology budgets in two different periods (2015 versus 2010), adjusted by inflation and increased activity. RESULTS: The hub-and-spoke model has been implemented as part of the consolidation process of pathology services in England. Consolidated pathology networks have achieved higher savings compared to non-consolidated single laboratories. There has been an increased role of private providers and savings were achieved with negligible personnel redundancies. CONCLUSIONS: Consolidated units have on average achieved larger cost savings than non-consolidated units but further analysis with stronger research design is required to independently evaluate the impact of pathology consolidation on both savings and quality.

Establishing an Anatomic Pathology Laboratory at Cleveland Clinic Abu Dhabi.

CONTEXT: - The Department of Anatomic Pathology is a division of the Pathology & Laboratory Medicine Institute at Cleveland Clinic Abu Dhabi. The hospital offers the same model of care as its US-based counterpart the Cleveland Clinic, established in 1921 in Cleveland, Ohio. Pathology services at Cleveland Clinic are internationally acclaimed: the endeavor for Cleveland Clinic Abu Dhabi was to create a parallel facility, with the same standards in a greenfield start-up environment. OBJECTIVE: - To narrate how we addressed challenges customary in any laboratory start-up and issues distinctive to our setting with the aim to provide a model for others involved in a similar undertaking. DATA SOURCES: - All information in this article is based on published literature obtained by search on internet-based search engines, Clinical and Laboratory Standards Institute, and the authors' firsthand experience. CONCLUSIONS: - Key considerations in establishing an anatomic pathology laboratory are careful planning and design, adherence to local and international regulatory standards, selection of equipment and supplies, appropriate staffing, development of a laboratory information system, and sound test validation. In addition to meeting our clinical needs, alliance with the US Cleveland Clinic had an integral role in establishing our laboratory and regional reputation.