Best Practice Recommendations for the Implementation of a Digital Pathology Workflow in the Anatomic Pathology Laboratory by the European Society of Digital and Integrative Pathology (ESDIP) (original) (raw)

Anatomic Pathology Laboratory Information Systems

Advances In Anatomic Pathology, 2012

The modern anatomic pathology laboratory depends on a reliable information infrastructure to register specimens, record gross and microscopic findings, regulate laboratory workflow, formulate and sign out report(s), disseminate them to the intended recipients across the whole health system, and support quality assurance measures. This infrastructure is provided by Anatomic Pathology Laboratory Information Systems (APLIS), which have evolved over decades and now are beginning to support evolving technologies like asset tracking and digital imaging. As digital pathology transitions from "the way of the future" to "the way of the present," the APLIS continues to be one of the key effective enablers of the scope and practice of pathology. In this review, we discuss the evolution, necessary components, architecture and functionality of the APLIS that are crucial to today's practicing pathologist and address the demands of emerging trends on the future APLIS.

Whole Slide Imaging Integration with Lab Information Systems, a Study of the Requirements, Processes and Procedures Enabling a Reporting-Based Workflow

Pathology and laboratory medicine international, 2023

Background: Significant advances have been achieved in the clinical implementation of digital pathology (DP) whole slide imaging (WSI). However, the workflow of the reporting process and the full integration of this technology into the lab and hospital information system have not been sufficiently addressed. There is not sufficient vendor and industry consideration for this in the development and implementation process. Methods: Exploring the requirements of direct integration of WSI with the lab and hospital information systems, demonstrating the workflow, challenges and best practices. Mapping and refining the process of movement of the digital slides. The anatomical pathology team, in collaboration with information technology and the vendor, establish the required scripts in order to enable direct integration, therefore allowing the laboratory a highly automated system of case, slide, and report movement. Results: Direct integration was achieved fulfilling the required goals specified by the workflow mapping. An automated case movement process was established in order to enable the pathologist a work management process from the digital platform. The integration errors and challenges were audited and reported. Conclusion: WSI digital pathology integration is achievable; however, it requires significant resource allocation adding to the technology acquirement.

Scientific and Regulatory Policy Committee (SRPC) Paper: Validation of Digital Pathology Systems in the Regulated Nonclinical Environment

Toxicologic Pathology, 2013

Digital Pathology Systems (DPS) are dynamic, image-based computer systems that enable the acquisition, management, and interpretation of pathology information generated from digitized glass slides. This article provides a roadmap for (1) qualification of a whole slide scanner (WSS) during a validation project, (2) validation of software required to generate the whole slide image (WSI), and (3) an introduction to visual digital image evaluation and image analysis. It describes a validation approach that can be utilized when validating a DPS. It is not the intent of this article to provide guidance on when validation of DPS is required. Rather, the article focuses on technical aspects of validation of the WSS system (WSS, IT infrastructure, and associated software) portion of a DPS and covers the processes of setting up the WSS for scanning a glass slide through saving a WSI on a server. Validation of a computerized system, such as a DPS, for use in a regulated nonclinical environment is governed by Code of Federal Regulations (CFR) Title 21 part 11: Electronic Records; Electronic Signature and predicate rules associated with Good Laboratory Practices documents including 21 CFR part 58. Similar regulation and predicate rules apply in the European Union and Japan.

Review on Digitalization of Basic Routine Procedures in Histopathology Laboratories

International Journal of Biosensors & Bioelectronics

Slowly but surely, healthcare is going digital. Many of the recent innovations in healthcare, from telemedicine and smart devices to the growing capabilities in managing big data, can be traced back to the adoption of new digital technologies that have fostered a different way of working. Across medicine's varied specialty areas, however, the adoption and progress of digital technology advances varies significantly. Digitalization in histopathology laboratory in Nigeria, is still a big setback, but there are digitalization in some of the usual routine practices like the automatic tissue processor which has overtaken the usual manual processor. In the area of sectioning, staining of tissues, mounting of slide and slide reading, we still face major setback in that regard. An improvement in digital diagnostic work, will go a long way in improving basic histopathological practice. From the reported usage of digital tools we can also conclude that possibilities for an overview image, measurements and annotations are much appreciated parts of the digital environment..

Digital Pathology in Europe: Coordinating Patient Care and Research Efforts

2009

The COST Action IC0604 "Telepathology Network in Europe" (EURO-TELEPATH) is an initiative of the COST (European Cooperation in the field of Scientific and Technical Research) framework, supported by the Seventh Framework Programme for research and technological development (FP7), of the European Union will be running from 2007 to 2011 and is aimed to coordinate research efforts to develop the most adequate technological framework for the management of multimedia electronic healthcare records (data and images) applied to Anatomic Pathology. Sixteen countries are participating in EURO-TELEPATH. Activities are organized in four Working Groups (WGs): WG1 -Pathology Business Modeling, WG2 -Informatics Standards in Pathology, WG3 -Images: Analysis, Processing, Retrieval and Management, and WG4 -Technology and Automation in Pathology. During the first year of work, the collaboration between software engineers, computer scientists, pathologists and other clinicians has been essential to detect three main areas of interest in digital pathology research: virtual microscopy scanning solutions, health informatics standards, and image processing and analysis. Research in these areas is essential to a correct approach to telepathology, including primary diagnosis, and secondary or teleconsultation services. Managing microscopic pathology images (virtual slides) is a challenge to existing information systems, mainly due to its large size, large number, and complex interpretation. Regarding interoperability, the integration of pathology reports and images into eHealth records is an essential objective that research groups should consider. Promoting participation in standards bodies (DICOM, IHE, HL7, IHTSDO) is an essential part of the project work. Understanding the business process of pathology departments in daily practice, including healthcare, education, research, and quality control activities, is the starting point to be sure that standardization efforts converge with user needs. Following a recent IHE proposal, coordination with public health services like national or regional tumor registries must also be supported. Virtual or digital slides are fostering the use of image processing and analysis in pathology not only for research purposes, but also in daily practice. Nowadays, further discussion is needed on the adequacy of current existing technical solutions, including for instance quality of images obtained by scanners, or the efficiency of image analysis applications.

Integrating the Health-care Enterprise Pathology and Laboratory Medicine Guideline for Digital Pathology Interoperability

Journal of Pathology Informatics, 2021

Integrating the health-care enterprise (IHE) is an international initiative to promote the use of standards to achieve interoperability among health information technology (HIT) systems and effective use of electronic health records (EHRs). IHE provides a forum for care providers, HIT experts, vendors, and other stakeholders in several clinical and operational domains to reach consensus on standards-based solutions to critical interoperability issues. The primary output of IHE is system implementation guides, called IHE Integration Profiles. IHE publishes each profile through a well-defined process of public review and trial implementation and gathers profiles that have reached final text status into an IHE Technical Frameworks (TFs). For more information regarding IHE in general, see www.ihe.net. For more technical information, see the IHE TFs General Introduction (http://www.ihe.net/Technical\_Frameworks/#GenIntro). For ongoing development work, see wiki.ihe.net. This paper delineates use cases and associated integration profiles that support interoperability among various components that comprise a holistic digital pathology workflow solution. The integration profiles are presented at a high level in this document. Each profile will be fully specified and published

Standards to Support Information Systems Integration in Anatomic Pathology

Archives of Pathology & Laboratory Medicine, 2009

Integrating anatomic pathology informationtext and images-into electronic health care records is a key challenge for enhancing clinical information exchange between anatomic pathologists and clinicians. The aim of the Integrating the Healthcare Enterprise (IHE) international initiative is precisely to ensure interoperability of clinical information systems by using existing widespread industry standards such as Digital Imaging and Communication in Medicine (DICOM) and Health Level Seven (HL7). Objective.-To define standard-based informatics transactions to integrate anatomic pathology information to the Healthcare Enterprise. Design.-We used the methodology of the IHE initiative. Working groups from IHE, HL7, and DICOM, with special interest in anatomic pathology, defined consensual technical solutions to provide end-users with improved access to consistent information across multiple information systems. Results.-The IHE anatomic pathology technical framework describes a first integration profile, ''Anatomic Pathology Workflow,'' dedicated to the diagnostic process including basic image acquisition and reporting solutions. This integration profile relies on 10 transactions based on HL7 or DICOM standards. A common specimen model was defined to consistently identify and describe specimens in both HL7 and DICOM transactions. Conclusion.-The IHE anatomic pathology working group has defined standard-based informatics transactions to support the basic diagnostic workflow in anatomic pathology laboratories. In further stages, the technical framework will be completed to manage whole-slide images and semantically rich structured reports in the diagnostic workflow and to integrate systems used for patient care and those used for research activities (such as tissue bank databases or tissue microarrayers).

Needs and workflow assessment prior to implementation of a digital pathology infrastructure for the US Air Force Medical Service

Journal of pathology informatics, 2013

Advances in digital pathology are accelerating integration of this technology into anatomic pathology (AP). To optimize implementation and adoption of digital pathology systems within a large healthcare organization, initial assessment of both end user (pathologist) needs and organizational infrastructure are required. Contextual inquiry is a qualitative, user-centered tool for collecting, interpreting, and aggregating such detailed data about work practices that can be employed to help identify specific needs and requirements. Using contextual inquiry, the objective of this study was to identify the unique work practices and requirements in AP for the United States (US) Air Force Medical Service (AFMS) that had to be targeted in order to support their transition to digital pathology. A pathology-centered observer team conducted 1.5 h interviews with a total of 24 AFMS pathologists and histology lab personnel at three large regional centers and one smaller peripheral AFMS pathology ...

Standardizing the use of whole slide images in digital pathology

Computerized medical imaging and graphics : the official journal of the Computerized Medical Imaging Society

Whole slide image Hospital information system (HIS) Laboratory information system (LIS) Integrating the healthcare enterprise (IHE) Picture archiving and communication system (PACS) Health level seven (HL7) Digital imaging and communications in medicine (DICOM) Clinical document architecture (CDA) Interoperability Digital pathology Telepathology Virtual microscopy a b s t r a c t

Recent advances in standards for Collaborative Digital Anatomic Pathology

Diagnostic Pathology

Collaborative Digital Anatomic Pathology refers to the use of information technology that supports the creation and sharing or exchange of information, including data and images, during the complex workflow performed in an Anatomic Pathology department from specimen reception to report transmission and exploitation. Collaborative Digital Anatomic Pathology can only be fully achieved using medical informatics standards. The goal of the international integrating the Healthcare Enterprise (IHE) initiative is precisely specifying how medical informatics standards should be implemented to meet specific health care needs and making systems integration more efficient and less expensive. To define the best use of medical informatics standards in order to share and exchange machine-readable structured reports and their evidences (including whole slide images) within hospitals and across healthcare facilities. Specific working groups dedicated to Anatomy Pathology within multiple standards or...