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Context.--Myriad forces are changing teaching and learning strategies throughout all stages and types of pathology education. Pathology educators and learners face the challenge of adapting to and adopting new methods and tools. The digital pathology transformation and the associated educational ecosystem are major factors in this setting of change. Objective.--To identify and collect resources, tools, and examples of educational innovations involving digital pathology that are valuable to pathology learners and teachers at each phase of professional development. Data Sources.--Sources were a literature review and the personal experience of authors and educators. Conclusions.--High-quality digital pathology tools and resources have permeated all the major niches within anatomic pathology and are increasingly well applied to clinical pathology for learners at all levels. Coupled with other virtual tools, the training landscape in pathology is highly enriched and much more accessible than in the past. Digital pathology is well suited to the demands of peer-to-peer education, such as in the introduction of new testing, grading, or other standardized practices. We found that digital pathology was well adapted to apply our current understanding of optimal teaching strategies and was effective at the undergraduate, graduate, postgraduate, and peer-to-peer levels. We curated and tabulated many existing resources within some segments of pathology. We identified several best practices for each training or educational stage based on current materials and proposed high-priority areas for potential future development. doi: 10.5858/arpa.2021-0473-RA, We could just as well be writing this paper with a manually powered typewriter, or with ink drawn from a well by a quill pen, had not a series of [...]

Each year, the Department of Pathology at the University of Michigan, Ann Arbor, organizes a case-based continuing medical education conference entitled New Frontiers in Pathology (https://pathology.med.umich.edu/newfrontiers) for community and academic [...]

Context.--The original guideline, 'Validating Whole Slide Imaging for Diagnostic Purposes in Pathology,' was published in 2013 and included 12 guideline statements. The College of American Pathologists convened an expert panel to update the guideline following standards established by the National Academies of Medicine for developing trustworthy clinical practice guidelines. Objective.--To assess evidence published since the release of the original guideline and provide updated recommendations for validating whole slide imaging (WSI) systems used for diagnostic purposes. Design.--An expert panel performed a systematic review of the literature. Frozen sections, anatomic pathology specimens (biopsies, curettings, and resections), and hematopathology cases were included. Cytology cases were excluded. Using the Grading of Recommendations Assessment, Development, and Evaluation approach, the panel reassessed and updated the original guideline recommendations. Results.--Three strong recommendations and 9 good practice statements are offered to assist laboratories with validating WSI digital pathology systems. Conclusions.--Systematic review of literature following release of the 2013 guideline reaffirms the use of a validation set of at least 60 cases, establishing intraobserver diagnostic concordance between WSI and glass slides and the use of a 2-week washout period between modalities. Although all discordances between WSI and glass slide diagnoses discovered during validation need to be reconciled, laboratories should be particularly concerned if their overall WSI-glass slide concordance is less than 95%., In 2013, the Pathology and Laboratory Quality Center for Evidence-based Guidelines (the Center) of the College of American Pathologists (CAP) released a guideline on the validation of whole slide imaging [...]

Context.--Pathologists may encounter extraneous pieces of tissue (tissue floaters) on glass slides because of specimen cross-contamination. Troubleshooting this problem, including performing molecular tests for tissue identification if available, is time consuming and often does not satisfactorily resolve the problem. Objective.--To demonstrate the feasibility of using an image search tool to resolve the tissue floater conundrum. Design.--A glass slide was produced containing 2 separate hematoxylin and eosin (H&E)-stained tissue floaters. This fabricated slide was digitized along with the 2 slides containing the original tumors used to create these floaters. These slides were then embedded into a dataset of 2325 whole slide images comprising a wide variety of H&E stained diagnostic entities. Digital slides were broken up into patches and the patch features converted into barcodes for indexing and easy retrieval. A deep learning-based image search tool was employed to extract features from patches via barcodes, hence enabling image matching to each tissue floater. Results.--There was a very high likelihood of finding a correct tumor match for the queried tissue floater when searching the digital database. Search results repeatedly yielded a correct match within the top 3 retrieved images. The retrieval accuracy improved when greater proportions of the floater were selected. The time to run a search was completed within several milliseconds. Conclusions.--Using an image search tool offers pathologists an additional method to rapidly resolve the tissue floater conundrum, especially for those laboratories that have transitioned to going fully digital for primary diagnosis. (Arch Pathol Lab Med. 2021;145:359-364; doi: 10.5858/arpa.2020-0034-OA), In routine clinical practice, pathologists may encounter extraneous pieces of tissue on glass slides that could be because of contamination from other specimens. These are typically called 'tissue floaters.' A [...]

* 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.--Advancements in genomic, computing, and imaging technology have spurred new opportunities to use quantitative image analysis (QIA) for diagnostic testing. Objective.--To develop evidence-based recommendations to improve accuracy, precision, and reproducibility in the interpretation of human epidermal growth factor receptor 2 (HER2) immunohistochemistry (IHC) for breast cancer where QIA is used. Design.--The College of American Pathologists (CAP) convened a panel of pathologists, histotechnologists, and computer scientists with expertise in image analysis, immunohistochemistry, quality management, and breast pathology to develop recommendations for QIA of HER2 IHC in breast cancer. A systematic review of the literature was conducted to address 5 key questions. Final recommendations were derived from strength of evidence, open comment feedback, expert panel consensus, and advisory panel review. Results.--Eleven recommendations were drafted: 7 based on CAP laboratory accreditation requirements and 4 based on expert consensus opinions. A 3-week open comment period received 180 comments from more than 150 participants. Conclusions.--To improve accurate, precise, and reproducible interpretation of HER2 IHC results for breast cancer, QIA and procedures must be validated before implementation, followed by regular maintenance and ongoing evaluation of quality control and quality assurance. HER2 QIA performance, interpretation, and reporting should be supervised by pathologists with expertise in QIA. (Arch Pathol Lab Med. 2019;143:1180-1195; doi: 10.5858/arpa.2018-0378-CP), In the United States, breast cancer is the most common type of cancer in women and 1 in 8 women will develop breast cancer in her lifetime. (1) For breast [...]

* April 12, 2017 marked a significant day in the evolution of digital pathology in the United States, when the US Food and Drug Administration announced its approval of the Philips IntelliSite Pathology Solution for primary diagnosis in surgical pathology. Although this event is expected to facilitate more widespread adoption of whole slide imaging for clinical applications in the United States, it also raises a number of questions as to the means by which pathologists might choose to incorporate this technology into their clinical practice. This article from the College of American Pathologists Digital Pathology Committee reviews frequently asked questions on this topic and provides answers based on currently available information.(Arch Pathol Lab Med. 2018;142:1383-1387; doi: 10.5858/arpa.2017-0496-CP), On April 12, 2017, the US Food and Drug Administration (FDA) announced the approval of the first whole slide imaging (WSI) system for primary diagnosis in surgical pathology. (1) This [...]

* Context.--Although primarily considered a respiratory illness, coronavirus disease 2019 (COVID-19) can cause gastrointestinal manifestations. Objective.--To evaluate histopathology and in situ hybridization for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in gastrointestinal samples from patients with recent and remote COVID-19. Design.--Patients with positive SARS-CoV-2 nasopharyngeal tests and a gastrointestinal tissue specimen were included. SARS-CoV-2 in situ hybridization (ISH) was performed on each sample. A subset had SARS-CoV-2 next-generation sequencing (NGS) performed. Results.--Twenty-five patients met inclusion criteria. Five had positive SARS-CoV-2 nasopharyngeal tests within 7 days of their gastrointestinal procedure. Two were ulcerative colitis patients on steroid therapy who lacked typical COVID-19 symptoms. Their colectomies showed severe ulcerative colitis; one demonstrated SARS-CoV-2 by NGS but a negative ISH. Another had an ischemic colon resected as a complication of the COVID-19 course; however, both ISH and NGS were negative. A fourth had a normal-appearing terminal ileum but positive ISH and NGS. The fifth patient had ileal ulcers with SARS-CoV-2 negativity by both modalities. The remaining 20 patients had positive nasopharyngeal tests an average of 53 days prior to procedure. None of their samples demonstrated SARS-CoV-2 ISH positivity, but one was positive on NGS despite a negative nasopharyngeal test. Conclusions.--Gastrointestinal findings from SARS-CoV2-infected patients ranged from normal with virus detected by ISH and NGS to bowel ischemia secondary to systemic viral effects without evidence of virus in the tissue. No distinct histologic finding was identified in those with gastrointestinal tissue specimens demonstrating SARS-CoV-2 positivity in this cohort. (Arch Pathol Lab Med. 2021;145:1062-1068; doi: 10.5858/arpa.2021-0137-SA, Coronavirus disease 2019 (COVID-19) is the cause of the current worldwide pandemic and continues to be a considerable global public health threat. Up to half of patients affected by COVID-19 [...]

* Context.--Augmented reality (AR) devices such as the Microsoft HoloLens have not been well used in the medical field. Objective.--To test the HoloLens for clinical and nonclinical applications in pathology. Design.--A Microsoft HoloLens was tested for virtual annotation during autopsy, viewing 3D gross and microscopic pathology specimens, navigating whole slide images, telepathology, as well as real-time pathology-radiology correlation. Results.--Pathology residents performing an autopsy wearing the HoloLens were remotely instructed with real-time diagrams, annotations, and voice instruction. 3D-scanned gross pathology specimens could be viewed as holograms and easily manipulated. Telepathology was supported during gross examination and at the time of intraoperative consultation, allowing users to remotely access a pathologist for guidance and to virtually annotate areas of interest on specimens in real-time. The HoloLens permitted radiographs to be coregistered on gross specimens and thereby enhanced locating important pathologic findings. The HoloLens also allowed easy viewing and navigation of whole slide images, using an AR workstation, including multiple coregistered tissue sections facilitating volumetric pathology evaluation. Conclusions.--The HoloLens is a novel AR tool with multiple clinical and nonclinical applications in pathology. The device was comfortable to wear, easy to use, provided sufficient computing power, and supported high-resolution imaging. It was useful for autopsy, gross and microscopic examination, and ideally suited for digital pathology. Unique applications include remote supervision and annotation, 3D image viewing and manipulation, telepathology in a mixed-reality environment, and real-time pathology-radiology correlation. (Arch Pathol Lab Med. 2018;142:638-644; doi: 10.5858/arpa.2017-0189-OA), Technology that offers an augmented reality (AR) experience (eg, Google Glass [Mountain View, California], Microsoft HoloLens [Redmond, Washington]) overlays a virtual world on top of a user's existing ('real') surroundings. [...]

* 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 [...]

Context.--Next-generation sequencing (NGS) is revolutionizing the discipline of laboratory medicine, with a deep and direct impact on patient care. Although it empowers clinical laboratories with unprecedented genomic sequencing capability, NGS has brought along obvious and obtrusive informatics challenges. Bioinformatics and clinical informatics are separate disciplines with typically a small degree of overlap, but they have been brought together by the enthusiastic adoption of NGS in clinical laboratories. The result has been a collaborative environment for the development of novel informatics solutions. Sustaining NGS-based testing in a regulated clinical environment requires institutional support to build and maintain a practical, robust, scalable, secure, and cost-effective informatics infrastructure. Objective.--To discuss the novel NGS informatics challenges facing pathology laboratories today and offer solutions and future developments to address these obstacles. Data Sources.--The published literature pertaining to NGS informatics was reviewed. The coauthors, experts in the fields of molecular pathology, precision medicine, and pathology informatics, also contributed their experiences. Conclusions.--The boundary between bioinformatics and clinical informatics has significantly blurred with the introduction of NGS into clinical molecular laboratories. Next-generation sequencing technology and the data derived from these tests, if managed well in the clinical laboratory, will redefine the practice of medicine. In order to sustain this progress, adoption of smart computing technology will be essential. Computational pathologists will be expected to play a major role in rendering diagnostic and theranostic services by leveraging 'Big Data' and modern computing tools. (Arch Pathol Lab Med. 2016;140:958-975; doi: 10.5858/arpa.2015-0507-RA), Next-generation sequencing (NGS) technology, using a massively parallel sequencing paradigm, has markedly altered the landscape of genomic medicine. The high-throughput capabilities of NGS systems have resulted in an exponential accumulation [...]

Context.--Microbiology laboratories are continually pursuing means to improve quality, rapidity, and efficiency of specimen analysis in the face of limited resources. One means by which to achieve these improvements is through the remote analysis of digital images. Telemicrobiology enables the remote interpretation of images of microbiology specimens. To date, the practice of clinical telemicrobiology has not been thoroughly reviewed. Objective.--To identify the various methods that can be employed for telemicrobiology, including emerging technologies that may provide value to the clinical laboratory. Data Sources.--Peer-reviewed literature, conference proceedings, meeting presentations, and expert opinions pertaining to telemicrobiology have been evaluated. Conclusions.--A number of modalities have been employed for telemicroscopy, including static capture techniques, whole slide imaging, video telemicroscopy, mobile devices, and hybrid systems. Telemicrobiology has been successfully implemented for several applications, including routine primary diagnosis, expert teleconsultation, and proficiency testing. Emerging areas of telemicrobiology include digital plate reading of bacterial cultures, mobile health applications, and computer-augmented analysis of digital images. To date, static image capture techniques have been the most widely used modality for telemicrobiology, despite newer technologies being available that may produce better quality interpretations. Telemicrobiology adds value, quality, and efficiency to the clinical microbiology laboratory, and increased adoption of telemicrobiology is anticipated. (Arch Pathol Lab Med. 2016;140:362-370; doi: 10.5858/arpa.2015-0116-RA), The role of informatics in the clinical microbiology laboratory is growing, which includes the practice of telemicrobiology. (1) Telemicrobiology is the use of telepathology technologies within the subdiscipline of clinical [...]

To the Editor.--We read with interest the Special Section in the March 2015 issue of the ARCHIVES about 'Empowering Pathology in the Era of the Electronic Health Record,' comprising 5 [...]

To the Editor.--We read with interest the recently published pilot study on digital whole slide imaging (WSI) for cervicovaginal cytology by Wright and colleagues. (1) Their study employed 7 cytologists [...]

Bar code-based tracking solutions, long present in clinical pathology laboratories, have recently made an appearance in anatomic pathology (AP) laboratories. Tracking of AP 'assets' (specimens, blocks, slides) can enhance laboratory efficiency, promote patient safety, and improve patient care. Routing of excess clinical material into research laboratories and biorepositories are other avenues that can benefit from tracking of AP assets. Implementing tracking is not as simple as installing software and turning it on. Not all tracking solutions are alike. Careful analysis of laboratory workflow is needed before implementing tracking to assure that this solution will meet the needs of the laboratory. Such analysis will likely uncover practices that may need to be modified before a tracking system can be deployed. Costs that go beyond simply that of purchasing software will be incurred and need to be considered in the budgeting process. Finally, people, not technology, are the key to assuring quality. Tracking will require significant changes in workflow and an overall change in the culture of the laboratory. Preparation, training, buy-in, and accountability of the people involved are crucial to the success of this process. This article reviews the benefits, available technology, underlying principles, and implementation of tracking solutions for the AP and research laboratory. (Arch Pathol Lab Med. 2013; 137:1798-1810; doi: 10.5858/arpa.2013-0125-SA), The reason for the success of several well-known companies (eg, Walmart, FedEx, Apple, Toyota) is related in part to their adoption of a lean manufacturing process, prioritization of supply chain [...]

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 [...]

To the Editor.--We read with interest the recent paper published by Volynskaya et al [1] in which the authors explain how their pathology informatics platform used digital pathology for primary [...]

To the Editor.--We read with interest the recent article by Nunes Rosado et al (1) investigating the utility of immunohistochemical staining with various blood vessel and lymphatic endothelial cell markers [...]

In 2007, the Futurescape of Anatomic Pathology meeting provided plenty of discussion about the technologic future of the field. Toward the end of that meeting, a "Reality Check" discussion provided [...]

Context.--Digital images have become an important component of cytology practice. They are used in telecytology, automated screening, educational material, and Web sites and have potential for use in proficiency testing. However, there has been no formal evaluation to date to determine if digital image manipulation (intentional or unintentional) can affect their interpretation. Objective.--To investigate whether alteration of digital cytology images affects diagnosis. Design.--Acquired digital images of ThinPrep Papanicolaou test slides were manipulated (rotated 90[degrees] and brightness, contrast, red-green-blue color, and luminosity adjusted) using Photoshop. A test composed of these altered images, along with their original (unaltered) image and exact duplicates was given to 22 cytologists (13 cytotechnologists, 8 cytopathologists, and 1 fellow). All images were rated as negative, atypical (atypical squamous cells of undetermined significance), low-grade squamous intraepithelial lesion, high-grade squamous intraepithelial lesion, or positive for cancer. Weighted [kappa] and heterogeneity [chi square] statistics were used to measure levels of agreement and assess concordance between groups. Results.--The level of agreement for identical duplicate images was excellent ([kappa] = 0.81), compared with the poor agreement for manipulated image pairs ([kappa] = 0.21), a statistically significant difference (P < .001). For all altered image types agreement was poor. There was no significant difference between cytotechnologists and cytopathologists in level of agreement (P = .56). Conclusions.--Manipulation of a Papanicolaou test digital image, irrespective of the specific category of cytologic material photographed, significantly affects its interpretation by both cytotechnologists and cytopathologists. This suggests that care needs to be taken when digital cytology images are used, to specifically ensure that their alteration does not affect diagnosis., A digital image is an image that is captured and stored as an electronic data file. Digital images permit image quality and content to be evaluated at the time of [...]

A 25-year-old man with a 2-month history of weight loss and night sweats complained of recent-onset left thigh pain and hyperesthesia. Radiologic investigation identified a large abscess within his left [...]

A 69-year-old white woman had a radical right nephrectomy for stage I renal cell carcinoma of clear cell type. She had yearly computed tomographic scans that showed no evidence of [...]

A placenta from a 28-year-old, African American, primigravida patient with sickle cell trait was received for routine pathologic examination. Prior to her current pregnancy, this patient had been admitted 3 [...]

A 51-year-old man presented with an excruciatingly painful lytic lesion in his first lumbar vertebral body. A biopsy of his spinal lesion revealed infiltrating sheets of atypical plasma cells. Serum [...]

The article focuses on the application of tools and techniques in the field of anatomic pathology (AP). Evolution along clinical pathology lines and radiology image lines are the two key trends in the practice of AP. Pattern recognition algorithms will improve accuracy, reliability, specificity and productivity as pathology becomes more digitized. Pathologists will also use computer-assisted, image-based, and analytic tools to assess and diagnose specimens when pathology is fully digitized.

Context.—On-line clinical laboratory manuals are a valuable resource for medical professionals. To our knowledge, no recommendations currently exist for their content or design. Objective.—To analyze publicly accessible on-line clinical laboratory manuals and to propose guidelines for their content. Design.—We conducted an Internet search for clinical laboratory manuals written in English with individual test listings. Four individual test listings in each manual were evaluated for 16 data elements, including sample requirements, test methodology, units of measure, reference range, and critical values. Web sites were also evaluated for supplementary information and search functions. Results.—We identified 48 on-line laboratory manuals, including 24 academic or community hospital laboratories and 24 commercial or reference laboratories. All manuals had search engines and/or test indices. No single manual contained all 16 data elements evaluated. An average of 8.9 (56%) elements were present (range, 4-14). Basic sample requirements (specimen and volume needed) were the elements most commonly present (98% of manuals). The frequency of the remaining data elements varied from 10% to 90%. Conclusions.—On-line clinical laboratory manuals originate from both hospital and commercial laboratories. While most manuals were user-friendly and contained adequate specimen-collection information, other important elements, such as reference ranges, were frequently absent. To ensure that clinical laboratory manuals are of maximal utility, we propose the following 13 data elements be included in individual test listings: test name, synonyms, test description, test methodology, sample requirements, volume requirements, collection guidelines, transport guidelines, units of measure, reference range, critical values, test availability, and date of latest revision. [ABSTRACT FROM AUTHOR]