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* Context.--The Logical Observation Identifiers Names and Codes (LOINC) system is supposed to facilitate interoperability, and it is the federally required code for exchanging laboratory data. Objective.--To provide an overview of LOINC, emerging issues related to its use, and areas relevant to the pathology laboratory, including the subtleties of test code selection and importance of mapping the correct codes to local test menus. Data Sources.--This review is based on peer-reviewed literature, federal regulations, working group reports, the LOINC database (version 2.65), experience using LOINC in the laboratory at several large health care systems, and insight from laboratory information system vendors. Conclusions.--The current LOINC database contains more than 55 000 numeric codes specific for laboratory tests. Each record in the LOINC database includes 6 major axes/parts for the unique specification of each individual observation or measurement. Assigning LOINC codes to a laboratory's test menu should be a defined process. In some cases, LOINC can aid in distinguishing laboratory data among different information systems, whereby such benefits are not achievable by relying on the laboratory test name alone. Criticisms of LOINC include the complexity and resource-intensive process of selecting the most correct code for each laboratory test, the real-world experience that these codes are not uniformly assigned across laboratories, and that 2 tests that may have the same appropriately assigned LOINC code may not necessarily have equivalency to permit interoperability of their result data. The coding system's limitations, which subsequently reduce the potential utility of LOINC, are poorly understood outside of the laboratory. (Arch Pathol Lab Med. 2020;144:229-239; doi: 10.5858/arpa.2018-0477-RA), The transformation of the US health care system from paper-based records to electronic reporting has brought significant changes to the practice of routine patient care, population research, and public health [...]

* Context.--There is growing interest in the use of digital pathology, especially whole slide imaging, for diagnostic purposes. Many issues need to be considered when incorporating this technology into a clinical laboratory. The College of American Pathologists (CAP) established a Digital Pathology Committee to support the development of CAP programs related to digital pathology. One of its many initiatives was a panel discussion entitled 'Implementing Whole-Slide Imaging for Clinical Use: What to Do and What to Avoid,' given for 3 years at the CAP annual meetings starting in 2014. Objectives.--To review major issues to consider when implementing whole slide imaging for clinical purposes as covered during the panel discussion. Design.--The views expressed and recommendations given are based primarily on the personal experience of the authors as early adopters of this technology. It is not intended to be an exhaustive review of digital pathology. Results.--Implementation is best approached in phases. Early efforts are directed toward identifying initial clinical applications and assembling an implementation team. Scanner selection should be based on intended use and budget. Recognizing pathologist concerns over the use of digital pathology for diagnostic purposes, ensuring adequate training, and performing appropriate validation studies will enhance adoption. Once implemented, the transition period from glass slide to image-based diagnostics will be associated with challenges, especially those related to a hybrid glass slide-digital slide workflow. Conclusions.--With appropriate preparation, planning, and stepwise implementation, whole slide imaging can be used safely and reliably for frozen sections, consultation, quality assurance, and primary diagnosis. (Arch Pathol Lab Med. 2017; 141:944-959; doi: 10.5858/arpa.2016-0074-OA), Interest in the use of digital pathology in clinical practice continues to grow. Digital pathology is being used for clinical work such as telepathology, education, and research. (1) Telepathology is [...]

Context.--Recognition of the importance of informatics to the practice of pathology has surged. Training residents in pathology informatics has been a daunting task for most residency programs in the United States because faculty often lacks experience and training resources. Nevertheless, developing resident competence in informatics is essential for the future of pathology as a specialty. Objective.--To develop and deliver a pathology informatics curriculum and instructional framework that guides pathology residency programs in training residents in critical pathology informatics knowledge and skills, and meets Accreditation Council for Graduate Medical Education Informatics Milestones. Design.--The College of American Pathologists, Association of Pathology Chairs, and Association for Pathology Informatics formed a partnership and expert work group to identify critical pathology informatics training outcomes and to create a highly adaptable curriculum and instructional approach, supported by a multiyear change management strategy. Results.--Pathology Informatics Essentials for Residents (PIER) is a rigorous approach for educating all pathology residents in important pathology informatics knowledge and skills. PIER includes an instructional resource guide and toolkit for incorporating informatics training into residency programs that vary in needs, size, settings, and resources. PIER is available at http://www.apcprods.org/ PIER (accessed April 6, 2016). Conclusions.--PIER is an important contribution to informatics training in pathology residency programs. PIER introduces pathology trainees to broadly useful informatics concepts and tools that are relevant to practice. PIER provides residency program directors with a means to implement a standardized informatics training curriculum, to adapt the approach to local program needs, and to evaluate resident performance and progress over time. doi: 10.5858/arpa.2016-0199-OA, Informatics has never been more relevant to the specialty and practice of pathology. Generating and managing information derived from processing, analysis, and interpretation of patient specimens form the core of [...]

Just as electronic health records are transforming the practice of medicine and health care information management, practicing in the era of the electronic health record offers opportunities, if not imperatives, for pathologists to take on new and 'transformative' professional and leadership roles for the organizations they serve. Experience indicates that clinicians will perceive pathologists and laboratories as responsible for all aspects of laboratory testing and information management, including order entry and results reporting, even though such functions may fall beyond the control of the laboratory. As described and expanded upon in the previous 4 articles of this series, the use of electronic health records dictates changes in how clinicians interact with laboratory information. In this environment, pathologists are uniquely positioned to act as the stewards for laboratory information in electronic health records and throughout health care organizations. (Arch Pathol Lab Med. 2015; 139:332-337; doi: 10.5858/arpa.2013-0714-SO), Viewing information management as an opportunity for pathologists is not new. As early as 1987, Korpman (1) described a role for the pathologist as medical information specialist within health care [...]

The increasing availability of laboratory information management modules within enterprise electronic health record solutions has resulted in some institutional administrators deciding which laboratory information system will be used to manage workflow within the laboratory, often with minimal input from the pathologists. This article aims to educate pathologists on many of the issues and implications this change may have on laboratory operations, positioning them to better evaluate and represent the needs of the laboratory during this decision-making process. The experiences of the authors, many of their colleagues, and published observations relevant to this debate are summarized. There are multiple dimensions of the interdependency between the pathology laboratory and its information system that must be factored into the decision. Functionality is important, but management authority and gap-ownership are also significant elements to consider. Thus, the pathologist must maintain an active role in the decision-making process to ensure the success of the laboratory. (Arch Pathol Lab Med. 2015;139:311-318; doi: 10.5858/arpa.2013-0711-SO), The Medicare and Medicaid Electronic Health Care Record (EHR) Incentive Program (also known as Meaningful Use) has driven a marked expansion of EHR use in health care organizations. (1-4) The [...]

In the era of the electronic health record, the success of laboratories and pathologists will depend on effective presentation and management of laboratory information, including test orders and results, and effective exchange of data between the laboratory information system and the electronic health record. In this third paper of a series that explores empowerment of pathology in the era of the electronic health record, we review key elements of managing laboratory information within the electronic health record and examine functional issues pertinent to pathologists and laboratories in the exchange of laboratory information between electronic health records and both anatomic and clinical pathology laboratory information systems. Issues with electronic order-entry and results-reporting interfaces are described, and considerations for setting up these interfaces are detailed in tables. The role of the laboratory medical director as mandated by the Clinical Laboratory Improvement Amendments of 1988 and the impacts of discordance between laboratory results and their display in the electronic health record are also discussed. (Arch Pathol Lab Med. 2015; 139:319-327; doi: 10.5858/arpa.2013-0712-SO), Laboratory information systems (LISs) are designed to meet workflow needs within the laboratory as well as interface with electronic health record (EHR) and billing systems. Configuration and maintenance of appropriate [...]

The Clinical Laboratory Improvement Amendments of 1988 include strict regulations for reporting content, and it falls on the named director to ensure that this content is available to the caregiver. With the electronic health record serving as the conduit to the end user of the laboratory data, the laboratory generally, and the director specifically, must verify accurate transmission of these content components. An understanding of regulatory and accreditation requirements is essential both to allow the proper discharge of these mandated responsibilities and to enforce the role and authority that the pathologist must have to ensure that these requirements are satisfied by the reporting system. The regulatory requirements will be discussed in the context of the Clinical Laboratory Improvement Amendments of 1988 standards; however, interpretation and expansion on these regulations exist both in Clinical Laboratory Improvement Amendments of 1988 inspection guidelines from the Centers for Medicare and Medicaid Services and in accreditation program requirements. This regulatory expectation both places the laboratory director in a position of risk and provides leverage to ensure meaningful and accurate communication of laboratory information. (Arch Pathol Lab Med. 2015; 139:328-331; doi: 10.5858/arpa.2013-0713-SO), Laboratory result reporting to caregivers falls under important regulatory and accreditation requirements. These requirements are intended to assure documentation of the source of the information, any supplemental information necessary for [...]

With growth spurred by recent federal efforts, electronic health records (EHRs) are transforming the practice of medicine and have important implications for pathologists, their laboratories, and the patients they serve. Beyond new EHR-related regulatory requirements, EHRs fundamentally alter the way clinicians interact with laboratory information, including test order entry and result reviewing. This article is the first in a series of 5 related articles whose goal is to provide a 'framework' for empowering pathologists to adapt to, and to succeed in, the era of expanding EHR use. This series aims to describe the environment for EHR uptake, to raise awareness of EHR-related issues that pathologists and laboratories face, and to explore new professional roles for pathologists as stewards of patients' laboratory information in EHRs. (Arch Pathol Lab Med. 2015;139:307-310; doi: 10.5858/arpa.2013-0709-SO), The increasing use of electronic health records (EHRs) has profound implications for pathology's core mission of delivering vital patient care information to health care providers. The use of EHRs in [...]

Context.--There is increasing interest in using whole slide imaging (WSI) for diagnostic purposes (primary and/ or consultation). An important consideration is whether WSI can safely replace conventional light microscopy as the method by which pathologists review histologic sections, cytology slides, and/or hematology slides to render diagnoses. Validation of WSI is crucial to ensure that diagnostic performance based on digitized slides is at least equivalent to that of glass slides and light microscopy. Currently, there are no standard guidelines regarding validation of WSI for diagnostic use. Objective.--To recommend validation requirements for WSI systems to be used for diagnostic purposes. Design.--The College of American Pathologists Pathology and Laboratory Quality Center convened a nonvendor panel from North America with expertise in digital pathology to develop these validation recommendations. A literature review was performed in which 767 international publications that met search term requirements were identified. Studies outside the scope of this effort and those related solely to technical elements, education, and image analysis were excluded. A total of 27 publications were graded and underwent data extraction for evidence evaluation. Recommendations were derived from the strength of evidence determined from 23 of these published studies, open comment feedback, and expert panel consensus. Results.--Twelve guideline statements were established to help pathology laboratories validate their own WSI systems intended for clinical use. Validation of the entire WSI system, involving pathologists trained to use the system, should be performed in a manner that emulates the laboratory's actual clinical environment. It is recommended that such a validation study include at least 60 routine cases per application, comparing intraobserver diagnostic concordance between digitized and glass slides viewed at least 2 weeks apart. It is important that the validation process confirm that all material present on a glass slide to be scanned is included in the digital image. Conclusions.--Validation should demonstrate that the WSI system under review produces acceptable digital slides for diagnostic interpretation. The intention of validating WSI systems is to permit the clinical use of this technology in a manner that does not compromise patient care. (Arch Pathol Lab Med. 2013; 137:1710-1722; doi: 10.5858/arpa.2013-0093-CP), In the last decade, digital imaging in pathology has been significantly impacted by the development and application of whole slide imaging (WSI) technology. (1-7) The automated WSI scanner is a [...]

Context.--High-resolution scanning technology provides an opportunity for pathologists to make diagnoses directly from whole slide images (WSIs), but few studies have attempted to validate the diagnoses so obtained. Objective.--To compare WSI versus microscope slide diagnoses of previously interpreted cases after a 1-year delayed re-review ('wash-out') period. Design.--An a priori power study estimated that 450 cases might be needed to demonstrate noninferiority, based on a null hypothesis: 'The true difference in major discrepancies between WSI and microscope slide review is greater than 4%.' Slides of consecutive cases interpreted by 2 pathologists 1 year prior were retrieved from files, and alternate cases were scanned at original magnification of x20. Each pathologist reviewed his or her cases using either a microscope or imaging application. Independent pathologists identified and classified discrepancies; an independent statistician calculated major and minor discrepancy rates for both WSI and microscope slide review of the previously interpreted cases. Results.--The 607 cases reviewed reflected the subspecialty interests of the 2 pathologists. Study limitations include the lack of cytopathology, hematopathology, or lymphoid cases; the case mix was not enriched with difficult cases; and both pathologists had interpreted several hundred WSI cases before the study to minimize the learning curve. The major and minor discrepancy rates for WSI were 1.65% and 2.31%, whereas rates for microscope slide reviews were 0.99% and 4.93%. Conclusions.--Based on our assumptions and study design, diagnostic review by WSI was not inferior to microscope slide review (P < .001). (Arch Pathol Lab Med. 2013;137:518-524; doi: 10.5858/arpa.2011-0678-OA), Although radiologists have been using digital imaging technology for diagnostic purposes for years, technology has only recently advanced to the point that interpretation of scanned images of whole microscope slides [...]

Context: Pathology informatics can be defined as the theory and practice of electronic information management related to the practice of anatomic and clinical pathology. Information used in the pursuit of patient care is the ultimate product of all laboratories and, consequently, to accomplish their missions, modern laboratories depend upon sophisticated information systems. To be successful in today&apos;s health care environment and to make the most appropriate decisions for their laboratories, all pathologists must have a baseline knowledge and skill-set infrastructure in informatics, while a subset of pathologists should have more sophisticated informatics knowledge and skill sets. Although traditional areas of anatomic and clinical pathology training employ learning objectives, knowledge expectations, and skill sets, such items have not been as well developed or widely implemented for pathology informatics training. Preliminary data suggest that most beginning pathology residents, even in today&apos;s "information age," have a limited understanding of many core topics in pathology informatics and that many residency programs lack a dedicated informatics curriculum. Pretest and posttest assessments indicate that a well-organized informatics curriculum can markedly improve residents&apos; funds of knowledge in both general computing and key areas of informatics. Objective: We present a draft proposal that defines standard curriculum and skill sets for resident training in pathology informatics. Design: The primary components of the proposal encompass knowledge/learning objectives and acquisition of certain proficiencies or skill sets. Knowledge objectives include those related to (1) general computing and (2) pathology informatics specifically. Skill set expectations include the ability to use software that facilitates and adds value to the work of practicing pathologists including (1) skills related to use of the laboratory information system (LIS) and (2) proficiencies related to use of productivity software. Suggestions are made regarding curriculum structure and implementation, computing infrastructure, advanced topics, and research projects. It is suggested that, to standardize and to enrich informatics curriculum offerings in residency programs, a pathology subspecialty organization or organizations should develop, maintain, and evolve an online informatics curriculum., Walter H. Henricks, MD (henricw@ccf.org)(1); Philip J. Boyer MD, PhD(2); James H. Harrison, MD, PhD(3); James C. Healy, MD.(4) (1)Department of Pathology and Laboratory Medicine, Cleveland Clinic Foundation, Cleveland, Ohio; [...]

Background: Integrating different data types from disparate sources represents a challenge and an opportunity to add value in the management of laboratory information. Laboratory analyses may generate multiple data types that may reside in separate systems, and integrating data into a report often requires laborious, error-prone methods. Kidney stone analysis is an example of such a situation. Nephrolithiasis is a common affliction with a high rate of recurrence. The results of laboratory stone analysis guide appropriate medical therapy to prevent recurrence. In addition to analyzing the biochemical composition of stones, the laboratory documents their number, size, color, and weight. Photographs of stones are an effective way to document gross features. Design: We developed a system for reporting kidney stone analysis results that provides 2 functions: database management and the combining of text, quantitative, graphical, and digital image data from different sources. The Kidney Stone reporting System (KISS) downloads patient and specimen information from the laboratory information system and associates laboratory accession numbers with both digital photographs of stones and analytical instrument data files. The KISS then generates an infrared absorption spectrum graph from the quantitative data file and combines the graph with the patient record and stone image to produce a concise report for referring clinicians. The database management environment facilitates archiving, retrieval, reprint, and query capabilities. Visual Basic (version 6.0, Microsoft Corporation, Redmond, Wash) modules specify the graphical user interface, manage data retrieval from various sources, and control other application logic. A structured query language (SQL) Server (version 7.0, Microsoft Corporation, Redmond, Wash) database engine maintains records and serves them to Crystal Report Designer (version 6.0, Seagate Inc, Vancouver, BC) for formatting and printing reports. Results: Implementation of the system has saved approximately 30 technologist hours per week. Users have received the system favorably, as it has reduced the number of manual steps necessary to produce a report. Transcription errors have been virtually eliminated. Conclusion: The KISS represents an innovative use of standard tools to integrate text, image, and graphical data from disparate systems into an integrated laboratory report, without the need for expensive interfaces., Shang-Che Lin, MBA, MS; Frederick Van Lente, PhD; Walter H. Henricks, MD (henricw@ccforg). Cleveland Clinic Foundation, Department of Pathology and Laboratory Medicine, Cleveland, [...]

Background: Although pathology informatics (PI) is essential to modern pathology practice, the field is often poorly understood. Pathologists who have received little to no exposure to informatics, either in training or in practice, may not recognize the roles that informatics serves in pathology. The purpose of this study was to characterize perceptions of PI by noninformatics-oriented pathologists and to do so at two large centers with differing informatics environments. Methods: Pathology trainees and staff at Cleveland Clinic (CC) and Massachusetts General Hospital (MGH) were surveyed. At MGH, pathology department leadership has promoted a pervasive informatics presence through practice, training, and research. At CC, PI efforts focus on production systems that serve a multi-site integrated health system and a reference laboratory, and on the development of applications oriented to department operations. The survey assessed perceived definition of PI, interest in PI, and perceived utility of PI. Results: The survey was completed by 107 noninformatics-oriented pathologists and trainees. A majority viewed informatics positively. Except among MGH trainees, confusion of PI with information technology (IT) and help desk services was prominent, even in those who indicated they understood informatics. Attendings and trainees indicated desire to learn more about PI. While most acknowledged that having some level of PI knowledge would be professionally useful and advantageous, only a minority plan to utilize it. Conclusions: Informatics is viewed positively by the majority of noninformatics pathologists at two large centers with differing informatics orientations. Differences in departmental informatics culture can be attributed to the varying perceptions of PI by different individuals. Incorrect perceptions exist, such as conflating PI with IT and help desk services, even among those who claim to understand PI. Further efforts by the PI community could address such misperceptions, which could help enable a better understanding of what PI is and is not, and potentially lead to increased acceptance by non-informaticist pathologists. [ABSTRACT FROM AUTHOR]