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Cloud computing has its strongest origins in the "web services" phase of internet development. In November 2000, Mind Electric CEO and [[distributed computing]] visionary Graham Glass, writing for IBM, described web services as "building blocks for creating open distributed systems" that "allow companies and individuals to quickly and cheaply make their digital assets available worldwide," while prognosticating that web services "will catalyze a shift from client-server to peer-to-peer architectures."<ref name="GlassTheWeb00">{{cite web |url=http://www-106.ibm.com/developerworks/library/ws-peer1.html |archiveurl=https://web.archive.org/web/20010424015036/http://www-106.ibm.com/developerworks/library/ws-peer1.html |title=The Web services (r)evolution, Part 1: Applying Web services to applications |author=Glass, G. |work=IBM developerWorks |publisher=IBM |date=November 2000 |archivedate=24 April 2001 |accessdate=21 August 2021}}</ref> At that point, the likes of Microsoft and IBM were already developing toolkits for creating and deploying web services<ref name="GlassTheWeb00" />, with IBM releasing an initial high-level report in May 2001 on IBM's web services architecture approach. In that paper, web services were described by its author Heather Kreger as allowing "companies to reduce the cost of doing e-business, to deploy solutions faster, and to open up new opportunities," while also allowing "applications to be integrated more rapidly, easily, and less expensively than ever before."<ref name="KregerWeb01">{{cite web |url=https://www.researchgate.net/profile/Heather-Kreger/publication/235720479_Web_Services_Conceptual_Architecture_WSCA_10/links/563a67e008ae337ef2984607/Web-Services-Conceptual-Architecture-WSCA-10.pdf |format=PDF |title=Web Services Conceptual Architecture (WSCA 1.0) |author=Kreger, H. |date=May 2001 |publisher=IBM Software Group |accessdate=21 August 2021}}</ref>
===Broad feature set of a pathology information management solution===


Here's a recap of thinking on web services at the turn of the century:
A pathology information management solution (PIMS) ...


* "[act as] building blocks for creating open distributed systems"<ref name="GlassTheWeb00" />
* "quickly and cheaply make ... digital assets available worldwide"<ref name="GlassTheWeb00" />
* "catalyze a shift from client-server to peer-to-peer architectures"<ref name="GlassTheWeb00" />
* "reduce the cost of doing e-business, to deploy solutions faster, and to open up new opportunities"<ref name="KregerWeb01" />
* "[allow] applications to be integrated more rapidly, easily, and less expensively than ever before"<ref name="KregerWeb01" />


We'll come back to that. For the next stop, however, we have to consider the case of Amazon and how they viewed web services at that time. Leading up to the twenty-first century, Amazon was beginning to expand beyond its book selling roots, opening up its marketplace to other third parties (affiliates) to sell their own goods on Amazon's platform. That effort required an expansion of IT infrastructure to support web-scale third-party selling, but as it turned out, a lot of that IT infrastructure, while reliable and cost-effective, had been previously added piecemeal, with many components getting "tangled" along the way. Amazon project leads and external partners were clamoring for better infrastructure services. This required untangling the IT and associated provider data into an internally scalable, centralized infrastructure that allowed for smoother communication and [[Information management|data management]] using well-documented APIs.<ref name="FurrierExclusive15">{{cite web |url=https://medium.com/@furrier/original-content-the-story-of-aws-and-andy-jassys-trillion-dollar-baby-4e8a35fd7ed |title=Exclusive: The Story of AWS and Andy Jassy’s Trillion Dollar Baby |author=Furrier, J. |work=Medium.com |date=29 January 2015 |accessdate=21 August 2021}}</ref><ref name="MillerHowAWS16">{{cite web |url=https://techcrunch.com/2016/07/02/andy-jassys-brief-history-of-the-genesis-of-aws/ |title=How AWS came to be |author=Miller, R. |work=TechCrunch |date=02 July 2016 |accessdate=21 August 2021}}</ref> By 2003, the company was indirectly acting as a services industry to its partners. "Why not act upon this strength?" was the sentiment that quickly developed that year, with Amazon choosing to use its internal compute, storage, and database infrastructure and related expertise to its advantage.<ref name="MillerHowAWS16" />  
* '''automated reflex testing''': Some PIMS vendors include pre-loaded, customizable lists of reflex tests associated with certain pathology procedures and their associated diagnoses. Optimally, these reflex texts are automatically suggested at specimen reception, based on specimen and/or pathology test type.<ref name="NPSoftware13">{{cite web |url=https://www.novopath.com/content/pdf/novopathbrochure.pdf |format=PDF |title=NovoPath - Software Advancing Patient Diagnostics |publisher=NovoPath, Inc |date=2013 |accessdate=05 September 2020}}</ref><ref name="PsycheWindo">{{cite web |url=https://psychesystems.com/enterprise-laboratory-information-software/windopath/ |title=WindoPath Ē.ssential |publisher=Psychē Systems Corporation |accessdate=05 September 2020}}</ref> Examples of pathology-driven reflex testing in use today include testing for additional biomarkers for non-small-cell lung carcinoma (NSCLC) adenocarcinoma<ref name="SundinPath19">{{cite journal |url=https://www.medlabmag.com/article/1619 |title=Pathology-Driven Reflex Testing of Biomarkers |journal=Medical Lab Management |author=Sundin, T. |volume=8 |issue=11 |page=6 |year=2019}}</ref>, HPV testing in addition to cervical cytology examination<ref name="FDANewApproaches19">{{cite web |url=https://www.fda.gov/media/122799/download |title=New Approaches in the Evaluation for High-Risk Human Papillomavirus Nucleic Acid Detection Devices |author=U.S. Food and Drug Administration |publisher=U.S. Food and Drug Administration |date=08 March 2019 |accessdate=05 September 2020}}</ref><ref name="StolerAdjunctive15">{{cite book |chapter=Chapter 9: Adjunctive Testing |title=The Bethesda System for Reporting Cervical Cytology |author=Stoler, M.H.; Raab, S.S.; Wilbur, D.C. |editor=Nayar, R.; Wilbur, D. |publisher=Springer |pages=287–94 |year=2015 |doi=10.1007/978-3-319-11074-5_9 |isbn=9783319110745}}</ref> (discussed further in "adjunctive testing"), and additional automatic testing based off routine coagulation assays at hemostasis labs.<ref name="MohammedDevel19">{{cite journal |title=Development and implementation of an expert rule set for automated reflex testing and validation of routine coagulation tests in a large pathology network |journal=International Journal of Laboratory Hematology |author=Mohammed, S.; Priebbenow, V.U.; Pasalic, L. et al. |volume=41 |issue=5 |pages=642–49 |year=2019 |doi=10.1111/ijlh.13078 |pmid=31271498}}</ref>


At that point, the paradigm of web services expanded to include infrastructure as a service or IaaS, with compute, storage, and database services running over the internet for web developers to utilize.<ref name="FurrierExclusive15" /><ref name="MillerHowAWS16" /> "If you believe developers will build applications from scratch using web services as primitive building blocks, then the operating system becomes the internet,” noted AWS CEO Andy Jassy in a 2015 retrospective interview.<ref name="FurrierExclusive15" /> From that concept evolved the idea of determining what it would take to allow any entity to run their technology applications over their web-service-based IaaS platform. In August 2006, Amazon introduced its Amazon Elastic Compute Cloud (Amazon EC2), "a web service that provides resizable compute capacity in the cloud."<ref name="AWSAnnounc06">{{cite web |url=https://aws.amazon.com/about-aws/whats-new/2006/08/24/announcing-amazon-elastic-compute-cloud-amazon-ec2---beta/ |title=Announcing Amazon Elastic Compute Cloud (Amazon EC2) - beta |publisher=Amazon Web Services |date=24 August 2006 |accessdate=21 August 2021}}</ref><ref name="ButlerAmazon06">{{cite journal |title=Amazon puts network power online |journal=Nature |author=Butler, D. |volume=444 |issue=528 |year=2006 |doi=10.1038/444528a}}</ref> This quickly prompted others in academic and scientific fields to continue the conversation of turning IT and its infrastructure into a service.<ref name="ButlerAmazon06" /><ref name="KeITeS06">{{cite journal |title=ITeS - Transcending the Traditional Service Model |journal=Proceedings of the 2006 IEEE International Conference on e-Business Engineering |author=Ke, J.-s. |page=2 |year=2006 |doi=10.1109/ICEBE.2006.66}}</ref> In turn, conversations changed, discussing the opportunities inherent to "cloud computing," including Google and IBM partnering to virtualize computers on new data centers for boosting academic research and teaching new computer science students<ref name="LohrGoogle07">{{cite web |url=http://www.nytimes.com/2007/10/08/technology/08cloud.html?_r=1&or |archiveurl=http://www.csun.edu/pubrels/clips/Oct07/10-08-07E.pdf |format=PDF |title=Google and I.B.M. Join in 'Cloud Computing' Research |author=Lohr, S. |work=The New York Times |date=08 October 2007 |archivedate=08 October 2007 |accessdate=21 August 2021}}</ref><ref name="HandHead07">{{cite journal |title=Head in the clouds |journal=Nature |author=Hand, E. |volume=449 |issue=963 |year=2007 |doi=10.1038/449963a}}</ref>, IBM releasing a white paper on cloud computing<ref name="BossCloud07">{{cite web |url=http://download.boulder.ibm.com/ibmdl/pub/software/dw/wes/hipods/Cloud_computing_wp_final_8Oct.pdf |archiveurl=https://web.archive.org/web/20090206015244/http://download.boulder.ibm.com/ibmdl/pub/software/dw/wes/hipods/Cloud_computing_wp_final_8Oct.pdf |format=PDF |title=Cloud Computing |author=Boss, G.; Malladi, P.; Quan, D. et al. |publisher=IBM Corporation |date=08 October 2007 |archivedate=06 February 2009 |accessdate=21 August 2021}}</ref> and announcing its Blue Cloud initiative<ref name="LohrIBM07">{{cite web |url=https://www.nytimes.com/2007/11/15/technology/15blue.html |title=I.B.M. to Push 'Cloud Computing,' Using Data From Afar |author=Lohr, S. |work=The New York Times |date=15 November 2007 |accessdate=21 August 2021}}</ref>, and Google doubling down on its cloud-based software offerings in competition with Microsoft.<ref name="LohrGoogleGets07">{{cite web |url=https://www.nytimes.com/2007/12/16/technology/16goog.html |archiveurl=https://signallake.com/innovation/GoogleMicrosoft121607.pdf |format=PDF |title=Google Gets Ready to Rumble With Microsoft |author=Lohr, S.; Helft, M. |work=The New York Times |date=16 December 2007 |archivedate=16 December 2007 |accessdate=21 August 2021}}</ref>
* '''adjunctive testing''': Adjunctive testing is testing "that provides information that adds to or helps interpret the results of other tests, and provides information useful for risk assessment."<ref name="SegensAdjunct11">{{cite web |url=https://medical-dictionary.thefreedictionary.com/adjunct+test |title=adjunct test |work=Segen's Medical Dictionary |date=2011 |accessdate=05 September 2020}}</ref> A common adjunctive test performed in [[cytopathology]] is HPV testing.<ref name="FDANewApproaches19" /><ref name="StolerAdjunctive15" /> The FDA described this as such in 2003, specifically in regards to expanding the use of the Digene HC2 assay as an adjunct to cytology<ref name="FDANewApproaches19" />:


In IBM's 2007 white paper, they described cloud computing as a "pool of virtualized computer resources" that can<ref name="BossCloud07" />:
<blockquote>In women 30 years and older, the HC2 High-Risk HPV DNA test can be used with Pap to adjunctively screen to assess the presence or absence of high-risk HPV types. This information, together with the physician’s assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management.</blockquote>


*  "host a variety of different workloads, including batch-style back-end jobs and interactive, user-facing applications";
:Some PIMS vendors allow users to manually add an adjunctive test to a primary pathology test, or in some cases this may be enabled as part of an automated reflex testing process.<ref name="TDHistoCyto">{{cite web |url=https://www.technidata-web.com/solutions-services/disciplines/anatomic-pathology |title=TD HistoCyto Livextens |publisher=Technidata SAS |accessdate=05 September 2020}}</ref> However, ensure that any such solution is capable of feeding any adjunctive test results into the final report (see the subsection on this topic).
*  "allow workloads to be deployed and scaled-out quickly through the rapid provisioning of virtual machines or physical machines";
"support redundant, self-recovering, highly scalable programming models that allow workloads to recover from many unavoidable hardware/software failures";
*  "monitor resource use in real time to enable rebalancing of allocations when needed"; and
*  "be a cost efficient model for delivering information services, reducing IT management complexity, promoting innovation, and increasing responsiveness through real-time workload balancing."


In 2011, the National Institute of Standards and Technology (NIST) came up with a more standards-based definition to cloud computing. They described it as "a model for enabling ubiquitous, convenient, on-demand network access to a shared pool of configurable computing resources (e.g., networks, servers, storage, applications, and services) that can be rapidly provisioned and released with minimal management effort or service provider interaction."<ref name="MellTheNIST11">{{cite web |url=https://nvlpubs.nist.gov/nistpubs/Legacy/SP/nistspecialpublication800-145.pdf |format=PDF |title=The NIST Definition of Cloud Computing |author=Mell, P.; Grance, T. |publisher=NIST |date=September 2011 |accessdate=21 August 2021}}</ref> They went on to highlight the five essential characteristics further<ref name="MellTheNIST11" />:
* '''demand management''': Similar to test optimization or clinical decision support, demand management mechanisms help laboratories reduce the amount of unnecessary and duplicate testing they perform. The idea of using demand management to reduce unnecessary pathology testing has been around since at least the beginning of the twenty-first century, if not well before, in the form of decision support systems and order request menus of informatics systems.<ref name="RaoPath03">{{cite journal |title=Pathology tests: is the time for demand management ripe at last? |journal=Journal of Clinical Pathology |author=Rao, G.G.; Crook, M.; Tillyer, M.L. |volume=56 |issue=4 |pages=243–48 |year=2003 |doi=10.1136/jcp.56.4.243 |pmid=12663633 |pmc=PMC1769923}}</ref> Lang described what the process of demand management would look like in a system like a [[laboratory information management system]] (LIMS) in 2013<ref name="LangLab13">{{cite journal |title=Laboratory demand management of repetitive testing – time for harmonisation and an evidenced based approach |journal=Clinical Chemistry and Laboratory Medicine |author=Lang, T. |volume=51 |issue=6 |pages=1139–40 |year=2013 |doi=10.1515/cclm-2013-0063 |pmid=23420284}}</ref>:


* On-demand self-service: The unilateral provision of computing resources should be an automatic or nearly automatic process.
<blockquote>When implementing a demand management tool it is important that the system used to manage a laboratory workload can correctly identify the patient and match requests with the patient’s medical record. Ideally there should be one unique identifier used (e.g., NHS number in the UK), which will allow the LIMS to interrogate the patient’s previous pathology result to allow identification of duplicate or inappropriate requests. If a subsequent request is blocked, then it is also important that there is real-time notification of a potential redundant test so that the requestor can make an informed choice on the clinical need of the test and if it is required to override the rule. It is important that there is a facility whereby the laboratory or requestor can record the reason for blocking a request or overriding the rule.</blockquote>
* Broad network access: Thin- or thick-client platforms, both hardwired and mobile, should allow for standardized, networkable access to those computing resources.
 
* Resource pooling: A multi-tenant model requires the provisioning of resources to serve a wide customer base, with a layer of abstraction that gives the user a sense of location independence from those resources.
:Today, some PIMS are designed to allow configurable rules and parameters to check for duplicate and unnecessary tests at various levels (e.g., by test ID or catalog type, activity type, or some other order level).<ref name="MorrisDemand18">{{cite journal |title=Demand management and optimization of clinical laboratory services in a tertiary referral center in Saudi Arabia |journal=Annals of Saudi Medicine |author=Morris, T.F.; Ellison, T.L.; Mutabbagani, M. et al. |volume=38 |issue=4 |pages=299–304 |year=2018 |doi=10.5144/0256-4947.2018.299 |pmid=30078029 |pmc=PMC6086671}}</ref><ref name="DXCLab">{{cite web |url=https://www.dxc.technology/healthcare/offerings/139499/139776-dxc_laboratory_information_management_lims |title=DXC Laboratory Information Management (LIMS) |publisher=DXC Technology Services, LLC |accessdate=05 September 2020}}</ref>
* Rapid elasticity: The platform's resources should be readily and/or automatically scalable commensurate with demand, such that the user sees no negative impact in their activities.
 
* Measured service: The resources should be automatically controlled and optimized by a measured service or metering system, transparently providing accurate and timely information about resource usage.
* '''consent management''': In clinical medicine, patients typically must sign a form indicating informed consent to medical treatment.<ref name="AMAInformed">{{cite web |url=https://www.ama-assn.org/delivering-care/ethics/informed-consent |title=Informed Consent |work=Code of Medical Ethics |publisher=American Medical Association |accessdate=22 September 2020}}</ref> Biobanking facilities, which store biospecimens, also must collect consent forms regarding how a patient's biospecimens may be used.<ref name="AveryBiobank18">{{cite web |url=https://www.biobanking.com/biobanking-consent-informing-human-subjects-of-the-possibilities/ |title=Biobanking Consent: Informing Human Subjects of the Possibilities |author=Avery, D. |work=Biobanking.com |date=16 July 2018 |accessdate=22 September 2020}}</ref> In all cases, these consent documents drive how and when certain actions take place. Though not common, some LIMS like LabVantage Pathology by Software Point<ref name="SPLabVantPath">{{cite web |url=https://softwarepoint.com/solutions/product/labvantage-pathology |title=LabVantage Pathology |publisher=Software Point Oy |accessdate=22 September 2020}}</ref> provide consent management mechanisms within their PIMS, giving pathologists the ability to quickly verify consent details electronically. In biobanking solutions, this consent management process may be more rigorous to ensure biospecimen donors' preferences and regulatory requirements are being carefully followed. For example, the system may need to be able to prevent further use of a biospecimen and trigger sample and data deletion protocols when a donor withraws their consent to use.<ref name="BikaNCV15">{{cite web |url=https://www.bikalims.org/downloads/bika-open-source-biobank-management-system/at_download/file |format=PDF |title=NCB-H3A Cape Town Biobank Management System - Functional Requirements Overview & Phase I Objectives |author=SANBI; Bika Lab Systems |publisher=Bika Lab Systems |date=20 November 2015 |accessdate=22 September 2020}}</ref>
 
* '''case management and review''': Most PIMS provide a means for managing pathology cases, recorded instances of disease and its attendant circumstances.<ref name="FarlexCase12">{{cite web |url=https://medical-dictionary.thefreedictionary.com/case |title=case |work=Farlex Partner Medical Dictionary |date=2012 |accessdate=25 September 2020}}</ref> This includes the management of case history, a collection of data concerning an individual, their family, their environment, their medical history, and other other information valuable for analyzing, diagnosing, reviewing, or otherwise instructing others on the case.<ref name="MKECase03">{{cite web |url=https://medical-dictionary.thefreedictionary.com/case |title=case |work=Miller-Keane Encyclopedia and Dictionary of Medicine, Nursing, and Allied Health, Seventh Edition |date=2003 |accessdate=25 September 2020}}</ref> Having an information system to better manage data entry, data analysis, case tracking, and case storage may aid in secondary and internal case reviews before final report, which have been shown to improve diagnostic accuracies and overall experiential knowledge of pathologists.<ref name="HuckKnowledge15">{{cite book |chapter=Chapter 7: Knowledge, Training, and Experience |title=Error Reduction and Prevention in Surgical Pathology |author=Huck, A.; Nosé, V. |editor=Nakhleh, R.E. |publisher=Springer |pages=103–114 |year=2015 |isbn=9781493923397 |url=https://books.google.com/books?id=HXAKBwAAQBAJ&pg=PA103}}</ref> Aspects of case manamagement and review that a PIMS may handle include automatic case creation, automatic and priority case assignment, and automatic case tracking, as well as limit case acces based on user permissions, and send alerts for clinical history follow-ups and other case statuses.<ref name="LLAnatom" /><ref name="PIMSPathX">{{cite web |url=http://pathxlis.com/downloads/PDFs/PathX%20-%20Capabilities%20Brochure.pdf |format=PDF |title=PathX Laboratory Information System |publisher=Physicians Independent Management Services |accessdate=25 September 2020}}</ref><ref name="LBAperioPathDX">{{cite web |url=https://www.leicabiosystems.com/digital-pathology/manage/aperio-path-dx/ |title=Aperio Path DX - Case Management Software |publisher=Leica Biosystems Nussloch GmbH |accessdate=25 September 2020}}</ref> Note that a handful of vendors such as Leica Biosystems provide stand-alone case management solutions that can be integrated with instruments and other LIS systems.<ref name="LBAperioPathDX" />
 
* '''workflow management''': The tools for workflow management have become increasingly common in PIMS and other laboratory informatics applications over the years, with the idea of using automation to improves efficiencies and accuracies in the lab. However, workflows and protocols can differ—sometimes significantly—from one pathology lab to another. Being able to configure workflow pathways in the PIMS to be compliant with required testing protocols is vital. This is especially important with the gradual transition to more digital pathology methods, where digitally sharing cases and automatically scanned slide images has great value.<ref name="XifinIsYour20">{{cite web |url=https://www.xifin.com/resources/blog/201912/your-lab-ready-ai-digital-pathology-workflow |title=Is Your Lab Ready for an AI Digital Pathology Workflow? |publisher=XIFIN, Inc |date=03 January 2020 |accessdate=25 September 2020}}</ref> As such, vendors such as Orchard Software and XIFIN provide solutions with configurable workflows to help labs translate their workflows into the system.<ref name="OSOrchPath" /><ref name="XIFINLabInfoSys">{{cite web |url=https://www.xifin.com/products/laboratory-information-system |title=Laboratory Information System |publisher=XIFIN, Inc |accessdate=25 September 2020}}</ref>
 
* '''speech recognition and transcription management''': Like other medical fields, pathologists may utilize dictation and transcription services within their workflow. This has traditionally involved the pathologist speaking while a transcriptionist manually records the words to paper, or the pathologist scribbling notes in shorthand, with the transcriptionist "translating" the notes to usable clinical documentation. This could include anything from specimen descriptions and diagnoses to pathology obsevations and procedure notes. PIMS vendors have over the years added more automated methods to such tasks in their solutions, however, such as speech recognition modules and transcription management tools that, for example, automatically assign recordings to a transcriber's pending work list.<ref name="NPSoftware13" /><ref name="SPLabVantPath" /><ref name="AspyraAnaPath" /><ref name="PIMSPathX" />
 
:It's important to note, however, though PIMS vendors may market the speech recognition component of their solution at being 99 percent effective, past studies have shown 88.9 to 96 percent accuracy, though with tiny annual gains as the technology matures.<ref name="HodgsonRisks16">{{cite journal |title=Risks and benefits of speech recognition for clinical documentation: A systematic review |journal=JAMIA |author=Hodgson, T.; Coiera, E. |volume=23 |issue=e1 |pages=e169–79 |year=2016 |doi=10.1093/jamia/ocv152 |pmid=26578226 |pmc=PMC4954615}}</ref><ref name="ZhouAnal18">{{cite journal |title=Analysis of Errors in Dictated Clinical Documents Assisted by Speech Recognition Software and Professional Transcriptionists |journal=JAMA Network Open |author=Zhou, L.; Blackley, S.V.; Kowalski, L. et al. |volume=1 |issue=3 |at=e180530 |year=2018 |doi=10.1001/jamanetworkopen.2018.0530 |pmid=30370424 |pmc=PMC6203313}}</ref> If speech recognition is being used in lieu of a hired transcriptionist, it's especially vital to add manual editing and review before reporting.<ref name="ZhouAnal18" /><ref name="MatthewsWhyMed19">{{cite web |url=https://www.healthitoutcomes.com/doc/why-medical-dictation-is-still-better-than-voice-recognition-for-now-0001 |title=Why Medical Dictation Is Still Better Than Voice Recognition ... For Now |author=Matthews, K. |work=Health IT Outcomes |date=20 December 2019 |accessdate=25 September 2020}}</ref>
 
* '''storage and tissue bank management''': Biorepositories and pathology laboratories go hand-in-hand. A significant example can be found with the relationship medical school biorepositories have with their pathology labs and departments, as with, for example, Duke University<ref name="DukeBiorep">{{cite web |url=https://pathology.duke.edu/core-facilities-services/biorepository-precision-pathology-center |title=Biorepository & Precision Pathology Center |publisher=Duke University School of Medicine |accessdate=22 September 2020}}</ref>, University of Illinois Chicago<ref name="UIC_UIHealthBio">{{cite web |url=https://rrc.uic.edu/cores/rsd/biorepository/ |title=UI Health Biorepository |publisher=University of Illinois Chicago |accessdate=22 September 2020}}</ref>, and the Icahn School of Medicine at Mount Sinai.<ref name="IcahnBiorep">{{cite web |url=https://icahn.mssm.edu/research/portal/resources/deans-cores/biorepository-and-pathology |title=Biorepository and Pathology |publisher=Icahn School of Medicine at Mount Sinai |accessdate=22 September 2020}}</ref> However, even small pathology laboratories must also responsibly store and track their specimens, blocks, and slides, as well as the storage variables affecting them. Any reputable laboratory informatics solution will be able to track the location of such items through barcode or RFID support, as well as allowing for the creation of named storage locations in the system. However, some informatics solutions like AgileBio's LabCollector go a step further, providing data logging modules that are capable of connecting to data logger hardware and other sensors that capture environmental storage information such as temperature, humidity, light level, carbon dioxide level, and pressure. When a variable is out of range, an alert can be sent and logged.<ref name="AgileBioDataLog">{{cite web |url=https://www.labcollector.com/labcollector-lims/add-ons/data-logger/ |title=Data Logger |publisher=AgileBio |accessdate=22 September 2020}}</ref> And full-fledged biorepository management LIMS may have all the bells and whistles, including randomized biospecimen location auditing.<ref name="AIBiobank">{{cite web |url=https://www.autoscribeinformatics.com/industries/biobank-management-systems |title=Biobank Management LIMS |publisher=Autoscribe Informatics, Inc |date=22 September 2020}}</ref>
 
* '''task management''': Task management is a typical feature of a laboratory informatics solution, giving laboratorians the ability to assign tasks to individuals or groups of individuals, including analyses, results review, and more. In pathology labs, additional task and even management may include, for example, case assignment, slide or block assignment, grossing, staining, or some other pathology task. Additionally, some may incorporate this task management and tracking into a dashboard, to facility timely access to short-term status individual cases and specimens, and long-term aggregate data about cases, workflow, and workloads.<ref name="HalwaniAReal16">{{cite journal |title=A real-time dashboard for managing pathology processes |journal=Journal of Pathology Informatics |author=Halwani, F.; Li, W.C.; Banerjee, D. et al. |volume=7 |at=24 |year=2016 |doi=10.4103/2153-3539.181768 |pmid=27217974 |pmc=PMC4872478}}</ref>
 
* '''billing management with code support''': Instead of turning to a separate billing solution, pathology labs can often turn to PIMS for billing management. Vendors of LIS and LIMS have recognized not only the value of adding billing management to their solutions but also the many benefits that come with tying in diagnosis and billing code support. For example, a pathologist scanning a specimen into the system can not only have a case automatically generated but also auto-generate diagnosis codes based on the specimen or slide's code. Additionally, as has been witnessed during the [[COVID-19]] pandemic, billing rules may change rapidly during extraordinary events, requiring rapid used-defined billing rule changes.<ref name="FerranteCOVID20">{{cite web |url=https://www.foley.com/en/insights/publications/2020/04/covid19-cms-monumental-changes-medicare-telehealth |title=COVID-19: CMS Issues Monumental Changes to Medicare Telehealth: What You Need to Know |author=Ferrante, T.B.; Goodman, R.B.; Wein, E.H. |work=Insights, a Foley & Lardner LLP Blog |date=03 April 2020 |accessdate=25 September 2020}}</ref> As such, support for CPT, ICD-10, SNOMED CT, and other types of autocoding are somewhat common in today's PIMS.<ref name="NPSoftware13" /><ref name="LLAnatom" /><ref name="PIMSPathX" /><ref name="AspyraAnaPath" />
 
* '''reflex and adjunctive test reporting''': Ensure that a PIMS is capable of feeding any adjunctive test results into the final report, along with the results from the primary tests. Using adjunctive HPV test results as an example, the report should optimally include details such as assay name, manufacturer, the HPV types it covers, results, and any applicable educational notes and suggestions.<ref name="StolerAdjunctive15" /> Be careful with simple color-coding of results for interpretation, as they can be easily misinterpreted, including by the colorblind. A combination of symbol with color will help limit such misinterpretation.<ref name="SundinPath19" />
 
* '''structured data entry''': The concept of structured data entry (SDE) is relatively simple, but it may still get taken for granted. At its core, SDE is all about ensuring that entered data is based on a set of predefined conditions or rules, usually implemented through standardized forms with pre-determined drop-down and auto-populated fields.<ref name="PHIIUnderst">{{cite web |url=https://www.phii.org/sites/default/files/resource/files/Understanding%20Clinical%20Data%20and%20Workflow%20Guide.docx |format=DOCX |title=Analyzing Clinical Data and Workflows - 4. Understanding Clinical Data and Workflow |work=EHR Toolkit |author=Public Health Informatics Institute |accessdate=22 September 2020}}</ref> This typically confers numerous advantages, including easier data entry, easier and more standardized reporting, decrease costs, improve translational research, and ensure better compatibility and integration across different information systems.<ref name="PHIIUnderst" /><ref name="BataviaUsing18">{{cite journal |title=Using structured data entry systems in the electronic medical record to collect clinical data for quality and research: Can we efficiently serve multiple needs for complex patients with spina bifida? |journal=Journal of Pediatric Rehabilitative Medicine |volume=11 |issue=4 |pages=303–09 |year=2018 |doi=10.3233/PRM-170525 |pmid=30507591 |pmc=PMC6491202}}</ref> As such, some PIMS vendors like NovoPath and Orchard Software describe their solutions as having SDE elements such as enabling intelligent auto-loading of diagnosis and billing codes during case loading, allowing input fields to be required, and synoptic reporting support.<ref name="NPSoftwarePDF">{{cite web |url=https://www.novopath.com/content/pdf/novopathbrochure.pdf |format=PDF |title=NovoPath - Software Advancing Patient Diagnostics |publisher=NovoPath, Inc |date=2013 |accessdate=22 September 2020}}</ref><ref name="OSOrchPath">{{cite web |url=https://www.orchardsoft.com/orchard-pathology.html |title=Orchard Pathology |publisher=Orchard Software Corporation |accessdate=22 September 2020}}</ref>
 
* '''synoptic reporting''': [[LIS feature#Synoptic reporting|Synoptic reporting]] involves a structured, pre-formatted "checklist" of clinically and morphologically relevant data elements that help make pathology reporting more efficient, uniform, and relevant to internal and external stakeholders. Another way to put this is that synoptic reporting is SDE applied to the pathology report, often based upon specific reporting protocols by professional or standards organizations like the College of American Pathologists (CAP).<ref name="LLAnatom">{{cite web |url=https://www.ligolab.com/solutions/anatomic-pathology-solution |title=Anatomic Pathology Solutions |publisher=LigoLab, LLC |accessdate=23 September 2020}}</ref><ref name="NPSoftwarePDF" /> Support for synoptic reporting methods is typical within PIMS solutions, including support for configurable templates that can be adapted to changing and custom reporting protocols.
 
* '''correlative and consultive reporting''': In the late 1930s, the concept of correlating pathology results with clinical observations (and pathology) was beginning to be addressed in student textbooks.<ref name="JAMATextbook40">{{cite journal |title=''Textbook of Pathology. A Correlation of Clinical Observations and Pathological Findings'' |journal=JAMA |volume=114 |issue=2 |page=184 |year=1940 |doi=10.1001/jama.1940.02810020088032}}</ref> Today, the concept remains integral in medical practice and toxicologic study reporting.<ref name="SmithConstruct16">{{cite journal |title=Constructing Comments in a Pathology Report: Advice for the Pathology Resident |journal=Archives of Pathology & Laboratory Medicine |author=Smith, S.M.; Yearsley, M. |volume=140 |issue=10 |pages=1023–24 |year=2016 |doi=10.5858/arpa.2016-0220-ED |pmid=27684971}}</ref><ref name="RamaiahInterp17">{{cite journal |title=Interpreting and Integrating Clinical and Anatomic Pathology Results: Pulling It All Together |journal=Toxicologic Pathology |author=Ramaiah, L.; Hinrichs, M.J.; Skuba, E.V. et al. |volume=45 |issue=1 |pages=223–37 |year=2017 |doi=10.1177/0192623316677068 |pmid=27879439}}</ref><ref name="AulbachOver19">{{cite journal |title=Overview and considerations for the reporting of clinical pathology interpretations in nonclinical toxicology studies |journal=Veterinary Clinical Pathology |author=Aulbach, A.; Vitsky, A.; Arndt, T. et al. |volume=48 |issue=3 |pages=389–99 |year=2019 |doi=10.1111/vcp.12772 |pmid=31556157}}</ref> On the clinical side, a pathologist may include the phrase "clinical correlation is recommended" and additional comments. And in some cases, a third-party pathology consultation, with their own respective comments, is involved with specimen analysis.<ref name="KaplanWhatIs14">{{cite web |url=https://blog.corista.com/corista-digital-pathology-blog/bid/389513/What-is-a-Pathology-Consultation-When-is-it-Used |title=What is a Pathology Consultation? When is it Used? |author=Kaplan, K. |work=Corista Digital Pathology Blog |date=19 June 2014 |accessdate=23 September 2020}}</ref> These correlative and consultive comments or reports play an important part in the overall final pathology report and should not be omitted, particularly if differing opinions are involved. Vendors such as Orchard Software, LigoLab, and Aspyra tout their solutions' ability to tie together multiple reports and comments across pathology disciplines and consultants into one concise report.<ref name="OSOrchPath" /><ref name="LLAnatom" /><ref name="AspyraAnaPath">{{cite web |url=http://aspyra.com/anatomic-pathology/ |title=Anatomic Pathology |publisher=Aspyra, LLC |accessdate=23 September 2020}}</ref>
 
* '''CAP Cancer Reporting Protocol support''': Previously mentioned was CAP and its reporting protocols. In particular, CAP has its Cancer Reporting Protocols, which the CAP describe as providing "guidelines for collecting the essential data elements for complete reporting of malignant tumors and optimal patient care."<ref name="CAPCancerProt20">{{cite web |url=https://www.cap.org/protocols-and-guidelines/cancer-reporting-tools/cancer-protocol-templates |title=Cancer Protocol Templates |publisher=College of American Pathologists |date=April 2020 |accessdate=23 September 2020}}</ref> In conjunction with its electronic Cancer Checklists (eCCs)<ref name="CAPeCC">{{cite web |url=https://www.cap.org/laboratory-improvement/proficiency-testing/cap-ecc |title=CAP eCC |publisher=College of American Pathologists |accessdate=23 September 2020}}</ref>, pathologists are able to integrate CAP cancer reporting protocols of tumors, resections, and select biopsies into their PIMS' workflow and ensure proper reporting outcomes. Some PIMS vendors (e.g., Orchard Software, LigoLab<ref name="OSOrchPath" /><ref name="LLAnatom" />) explicitly indicate their solution integrates CAP's eCC templates and reporting protocols into their solution.
 
* '''annotated organ mapping''': In the world of PIMS, organ mapping refers to the concept of placing location-specific diagnostic information from specimen analyses into an anatomical diagram, typically during reporting, to more clearly communicate the results of those analyses. PIMS vendor WebPathLab, Inc. demonstrates this concept well with its Auto Organ Map Module, which not only shows an organ map in the rport but also simplifies data entry for the pathologist using SDE.<ref name="WPLAuto19">{{cite web |url=https://www.youtube.com/watch?v=NLr5_pLgYpg |title=AutoProstateMap |work=YouTube |author=WebPathLab, Inc |date=22 April 2019 |accessdate=23 September 2020}}</ref><ref name="WPLGUAuto">{{cite web |url=http://webpathlab.com/solutions/gu-auto-organ-map/ |title=GU Auto Organ Map Module |publisher=WebPathLab, Inc |accessdate=23 September 2020}}</ref> They use the prostate as an example, and explain that "selecting the predetermined number of quadrants in the prostate &#91;diagram&#93;, the system autopopulates the specimen description to each corresponding quadrant, and autofills the text for the Gross Description field, leaving only the dimension of each core to be entered by the grosser." NovoPath and Psyche Systems Corporation are additional examples of vendors incorporating organ mapping into their PIMS.<ref name="PsycheWindo" /><ref name="NPSoftwarePDF" />
 
* '''stain panel and unstained/control slide support''': A positive control slide is typically used to qualitatively assess how well a non-hematoxylin-eosin (non-H&E) or "special" stain performs against a gold standard like H&E, and the positive control is usually included with manufactured unstained slides (e.g., see Newcomer Supply's [https://www.newcomersupply.com/documents/product-flyers/Control%20Slide%20Brochure.pdf control slide catalog]). These slides may be used in histopathology (gauging the manifestation of disease in a tissue) and immunopathology (gauging immune response through visualization of an antibody-antigen interaction in a tissue). In particular, immunopathology and its associated immunohistochemistry may turn to special stain panels, which utilize multiple immunochemical stains to visualize the presence of more than one biomarker expression at the same time.<ref name="ShieldImmuno96">{{cite journal |title=Immunocytochemical staining of cytologic specimens. How helpful is it? |journal=American Journal of Clinical Pathology |author=Shield, P.W.; Perkins, G.; Wright, R.G. |volume=105 |issue=2 |pages=157–62 |year=1996 |doi=10.1093/ajcp/105.2.157 |pmid=8607438}}</ref><ref name="MartinEval14">{{cite journal |title=Evaluation of intestinal biopsies for pediatric enteropathy: A proposed immunohistochemical panel approach |journal=American Journal of Surgical Pathology |author=Martin, B.A.; Kerner, J.A.; Hazard, F.K. et al. |volume=38 |issue=10 |pages=1387–95 |year=2014 |doi=10.1097/PAS.0000000000000314 |pmid=25188866}}</ref><ref name="TorbensonImmuno19">{{cite web |url=https://abdominalkey.com/immunohistochemistry-and-special-stains-in-liver-pathology/ |title=Chapter 4. Immunohistochemistry and Special Stains in Liver Pathology |author=Torbenson, M.S. |work=Abdominalkey |date=24 November 2019 |accessdate=23 September 2020}}</ref> Vendors like NovoPath and Integrated Business Solutions Group explicitly state their solution supports the management of these types of slides and stain panels.<ref name="NPSoftwarePDF" /><ref name="IBSGLabLion">{{cite web |url=https://www.lablion.com/lablion-lis-laboratory-information-system |title=LABLION Software Suite |publisher=Integrated Business Solutions Group, LLC |accessdate=23 September 2020}}</ref>
 
* '''grossing support''': In medical terms, the adjective "gross" means "visible without the aid of a microscope."<ref name="MWGross">{{cite web |url=https://www.merriam-webster.com/dictionary/gross |title=Gross |work=Merriam-Webster.com Dictionary |publisher=Merriam-Webster |accessdate=23 September 2020}}</ref> By extension, gross examination (i.e., grossing) involves a macroscopic visual assessment of a biospecimen before preparation for microscopy, in order to gleen diagnostic information. Grossing remains a valuable skill used in modern pathology.<ref name="RutgushreeGrossing18">{{cite journal |title=Grossing of tissue specimens in oral pathology - Elemental guidelines |journal=International Journal of Oral Health Sciences |author=Ruthushree, T.; Harsha, M.; Amberkar, V.S. |volume=8 |issue=2 |pages=63–7 |year=2018 |doi=10.4103/ijohs.ijohs_32_18}}</ref><ref name="SchubertTheArt19">{{cite web |url=https://thepathologist.com/inside-the-lab/the-art-of-grossing |title=The Art of Grossing: Gross examination underpins all diagnoses based on tissue samples – but is this vital skill given the credit it deserves? |author=Schubert, M.; Nashm C; McCoy, J. |work=The Pathologist |date=26 November 2019 |accessdate=23 September 2020}}</ref> Some PIMS provide a grossing menu for pathologists to scan in and include commentary about a gross examination of a specimen.<ref name="LLAnatom" />
 
* '''high-risk patient follow-up''': A 2015 study published in ''Annals of Family Medicine'' showed evidence that "patients with high clinical complexity and high risk of readmission" benefited from early outpatient follow-up.<ref name="JosztHigh15">{{cite web |url=https://www.ajmc.com/view/high-risk-patients-benefit-significantly-from-early-follow-up-post-hospital-discharge |title=High-Risk Patients Benefit Significantly From Early Follow-up Post Hospital Discharge |author=Joszt, L. |work=The American Journal of Managed Care |date=20 April 2015 |accessdate=23 September 2020}}</ref><ref name="JacksonTimeli15">{{cite journal |title=Timeliness of Outpatient Follow-up: An Evidence-Based Approach for Planning After Hospital Discharge |journal=Annals of Family Medicine |author=Jackson, C.; Shahsahebi, M.; Wedlake, T. et al. |volume=13 |issue=2 |pages=115–22 |year=2015 |doi=10.1370/afm.1753}}</ref> The authors concluded : "Follow-up within seven days was associated with meaningful reductions in readmission risk for patients with multiple chronic conditions and a greater than 20% baseline risk of readmission, a group that represented 24% of discharged patients." Presumably some health care systems are synthesizing that information into their patient workflows, likely through some sort of scheduled event and alert in their primary informatics system, e.g., an [[electronic health record]] (EHR) system.<ref name="FutrellHealth18">{{cite web |url=https://www.mlo-online.com/information-technology/lis/article/13009479/health-information-technology-can-support-population-health-management |title=Health information technology can support population health management |author=Futrell, K. |work=Medical Laboratory Observer |date=18 April 2018 |accessdate=23 September 2020}}</ref> Though not common, at least one PIMS vendor—LigoLab, LLC—indicates their solution helps address high-risk patient follow-up, though it's not clear how.<ref name="LLAnatom" />
 
* '''research animal support''': Non-clinical pathology and toxicology laboratories assisting with research and evaluation studies may be handling non-human specimens or even live research animals. Additional data about these animals, animal groups, and animal tissues may need to be carefully documented as part of a study. As such, some solutions such as Instem's Provantis preclinical pathology solution are designed to record specific animal and group identifiers, animal cross-reference information, organ weight ratios, palpable mass diagnoses, and other attributes for reporting.<ref name="InstemProvantis">{{cite web |url=https://www.instem.com/solutions/provantis/index.php#2 |title=Provantis: Integrated preclinical software |publisher=Instem LSS Limited |accessdate=23 September 2020}}</ref>


When we compare these 2007 and 2011 definitions of cloud computing with the comments on web services by Glass and Kreger at the turn of the century (as well as our own derived definition prior), we can't help but see how the early vision for cloud computing has taken shape today. First, web services can indeed be paired with other technologies to form a distributed system, in this case a centralized and scalable computing infrastructure that can be used by practically anyone to run software, develop applications, and "host a variety of different workloads."<ref name="BossCloud07" /> Second, those workloads can be quickly deployed worldwide, wherever there is internet access, and typically at a fair price, when compared to the costs of on-premises data management.<ref name="ViolinoWhere20">{{cite web |url=https://www.infoworld.com/article/3532288/where-to-look-for-cost-savings-in-the-cloud.html |title=Where to look for cost savings in the cloud |author=Violino, B. |work=InfoWorld |date=16 March 2020 |accessdate=21 August 2021}}</ref> Third, new opportunities are indeed developing for organizations seeking to tap into the on-demand, rapid, scalable, and cost-efficient nature of cloud computing.<ref name="OjalaDiscover16">{{cite journal |title=Discovering and creating business opportunities for cloud services |journal=Journal of Systems and Software |author=Ojala, A. |volume=113 |pages=408–17 |year=2016 |doi=10.1016/j.jss.2015.11.004}}</ref><ref name="PetteyCloud20">{{cite web |url=https://www.gartner.com/smarterwithgartner/cloud-shift-impacts-all-it-markets/ |title=Cloud Shift Impacts All IT Markets |author=Pettey, C. |work=Smarter with Gartner |date=26 October 2020 |accessdate=21 August 2021}}</ref> And finally, benefits are being seen in the integration of applications via the cloud, particularly as more options for multicloud and hybrid cloud integration develop.<ref name="PetteyFiveApp19">{{cite web |url=https://www.gartner.com/smarterwithgartner/5-approaches-cloud-applications-integration/ |title=5 Approaches to Cloud Applications Integration |author=Pettey, C. |work=Smarter with Gartner |date=14 May 2019 |accessdate=21 August 2021}}</ref> The early vision that perhaps hasn't been realized is found in Glass' "shift from client-server to peer-to-peer architectures," though discussions about the promise of peer-to-peer cloud computing have occurred since.<ref name="BabaogluEscape14">{{cite journal |title=The People's Cloud |journal=IEEE Spectrum |author=Babaoglu, O.; Marzolla, M. |volume=51 |issue=10 |pages=50–55 |year=2014 |doi=10.1109/MSPEC.2014.6905491 |url=https://spectrum.ieee.org/computing/networks/escape-from-the-data-center-the-promise-of-peertopeer-cloud-computing}}</ref>


Though clearly linked to web services and the early vision of cloud computing in the 2000s, the cloud computing of the 2020s is a remarkably more advanced and continually evolving technology. However, it's still not without its challenges today. The data security, privacy, and governance of computing in general, and cloud computing in particular, will continue to require more rigorous approaches, as will reducing remaining data silos in organizations with pivots to hybrid cloud, multicloud, and serverless cloud implementations.<ref name="Goodison10Fut20">{{cite web |url=https://www.crn.com/news/cloud/10-future-cloud-computing-trends-to-watch-in-2021 |title=10 Future Cloud Computing Trends To Watch In 2021 |author=Goodison, D. |work=CRN |date=20 November 2020 |accessdate=21 August 2021}}</ref><ref name="DTCCCloud20">{{cite web |url=http://www.dtcc.com/-/media/Files/Downloads/WhitePapers/DTCC-Cloud-Journey-WP |format=PDF |title=Cloud Technology: Powerful and Evolving |author=DTCC |date=November 2020 |accessdate=21 August 2021}}</ref> But what is "hybrid cloud"? "Serverless cloud?" The next section goes into further detail.


==References==
==References==
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Latest revision as of 13:27, 6 September 2021

Broad feature set of a pathology information management solution

A pathology information management solution (PIMS) ...


  • automated reflex testing: Some PIMS vendors include pre-loaded, customizable lists of reflex tests associated with certain pathology procedures and their associated diagnoses. Optimally, these reflex texts are automatically suggested at specimen reception, based on specimen and/or pathology test type.[1][2] Examples of pathology-driven reflex testing in use today include testing for additional biomarkers for non-small-cell lung carcinoma (NSCLC) adenocarcinoma[3], HPV testing in addition to cervical cytology examination[4][5] (discussed further in "adjunctive testing"), and additional automatic testing based off routine coagulation assays at hemostasis labs.[6]
  • adjunctive testing: Adjunctive testing is testing "that provides information that adds to or helps interpret the results of other tests, and provides information useful for risk assessment."[7] A common adjunctive test performed in cytopathology is HPV testing.[4][5] The FDA described this as such in 2003, specifically in regards to expanding the use of the Digene HC2 assay as an adjunct to cytology[4]:

In women 30 years and older, the HC2 High-Risk HPV DNA test can be used with Pap to adjunctively screen to assess the presence or absence of high-risk HPV types. This information, together with the physician’s assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management.

Some PIMS vendors allow users to manually add an adjunctive test to a primary pathology test, or in some cases this may be enabled as part of an automated reflex testing process.[8] However, ensure that any such solution is capable of feeding any adjunctive test results into the final report (see the subsection on this topic).
  • demand management: Similar to test optimization or clinical decision support, demand management mechanisms help laboratories reduce the amount of unnecessary and duplicate testing they perform. The idea of using demand management to reduce unnecessary pathology testing has been around since at least the beginning of the twenty-first century, if not well before, in the form of decision support systems and order request menus of informatics systems.[9] Lang described what the process of demand management would look like in a system like a laboratory information management system (LIMS) in 2013[10]:

When implementing a demand management tool it is important that the system used to manage a laboratory workload can correctly identify the patient and match requests with the patient’s medical record. Ideally there should be one unique identifier used (e.g., NHS number in the UK), which will allow the LIMS to interrogate the patient’s previous pathology result to allow identification of duplicate or inappropriate requests. If a subsequent request is blocked, then it is also important that there is real-time notification of a potential redundant test so that the requestor can make an informed choice on the clinical need of the test and if it is required to override the rule. It is important that there is a facility whereby the laboratory or requestor can record the reason for blocking a request or overriding the rule.

Today, some PIMS are designed to allow configurable rules and parameters to check for duplicate and unnecessary tests at various levels (e.g., by test ID or catalog type, activity type, or some other order level).[11][12]
  • consent management: In clinical medicine, patients typically must sign a form indicating informed consent to medical treatment.[13] Biobanking facilities, which store biospecimens, also must collect consent forms regarding how a patient's biospecimens may be used.[14] In all cases, these consent documents drive how and when certain actions take place. Though not common, some LIMS like LabVantage Pathology by Software Point[15] provide consent management mechanisms within their PIMS, giving pathologists the ability to quickly verify consent details electronically. In biobanking solutions, this consent management process may be more rigorous to ensure biospecimen donors' preferences and regulatory requirements are being carefully followed. For example, the system may need to be able to prevent further use of a biospecimen and trigger sample and data deletion protocols when a donor withraws their consent to use.[16]
  • case management and review: Most PIMS provide a means for managing pathology cases, recorded instances of disease and its attendant circumstances.[17] This includes the management of case history, a collection of data concerning an individual, their family, their environment, their medical history, and other other information valuable for analyzing, diagnosing, reviewing, or otherwise instructing others on the case.[18] Having an information system to better manage data entry, data analysis, case tracking, and case storage may aid in secondary and internal case reviews before final report, which have been shown to improve diagnostic accuracies and overall experiential knowledge of pathologists.[19] Aspects of case manamagement and review that a PIMS may handle include automatic case creation, automatic and priority case assignment, and automatic case tracking, as well as limit case acces based on user permissions, and send alerts for clinical history follow-ups and other case statuses.[20][21][22] Note that a handful of vendors such as Leica Biosystems provide stand-alone case management solutions that can be integrated with instruments and other LIS systems.[22]
  • workflow management: The tools for workflow management have become increasingly common in PIMS and other laboratory informatics applications over the years, with the idea of using automation to improves efficiencies and accuracies in the lab. However, workflows and protocols can differ—sometimes significantly—from one pathology lab to another. Being able to configure workflow pathways in the PIMS to be compliant with required testing protocols is vital. This is especially important with the gradual transition to more digital pathology methods, where digitally sharing cases and automatically scanned slide images has great value.[23] As such, vendors such as Orchard Software and XIFIN provide solutions with configurable workflows to help labs translate their workflows into the system.[24][25]
  • speech recognition and transcription management: Like other medical fields, pathologists may utilize dictation and transcription services within their workflow. This has traditionally involved the pathologist speaking while a transcriptionist manually records the words to paper, or the pathologist scribbling notes in shorthand, with the transcriptionist "translating" the notes to usable clinical documentation. This could include anything from specimen descriptions and diagnoses to pathology obsevations and procedure notes. PIMS vendors have over the years added more automated methods to such tasks in their solutions, however, such as speech recognition modules and transcription management tools that, for example, automatically assign recordings to a transcriber's pending work list.[1][15][26][21]
It's important to note, however, though PIMS vendors may market the speech recognition component of their solution at being 99 percent effective, past studies have shown 88.9 to 96 percent accuracy, though with tiny annual gains as the technology matures.[27][28] If speech recognition is being used in lieu of a hired transcriptionist, it's especially vital to add manual editing and review before reporting.[28][29]
  • storage and tissue bank management: Biorepositories and pathology laboratories go hand-in-hand. A significant example can be found with the relationship medical school biorepositories have with their pathology labs and departments, as with, for example, Duke University[30], University of Illinois Chicago[31], and the Icahn School of Medicine at Mount Sinai.[32] However, even small pathology laboratories must also responsibly store and track their specimens, blocks, and slides, as well as the storage variables affecting them. Any reputable laboratory informatics solution will be able to track the location of such items through barcode or RFID support, as well as allowing for the creation of named storage locations in the system. However, some informatics solutions like AgileBio's LabCollector go a step further, providing data logging modules that are capable of connecting to data logger hardware and other sensors that capture environmental storage information such as temperature, humidity, light level, carbon dioxide level, and pressure. When a variable is out of range, an alert can be sent and logged.[33] And full-fledged biorepository management LIMS may have all the bells and whistles, including randomized biospecimen location auditing.[34]
  • task management: Task management is a typical feature of a laboratory informatics solution, giving laboratorians the ability to assign tasks to individuals or groups of individuals, including analyses, results review, and more. In pathology labs, additional task and even management may include, for example, case assignment, slide or block assignment, grossing, staining, or some other pathology task. Additionally, some may incorporate this task management and tracking into a dashboard, to facility timely access to short-term status individual cases and specimens, and long-term aggregate data about cases, workflow, and workloads.[35]
  • billing management with code support: Instead of turning to a separate billing solution, pathology labs can often turn to PIMS for billing management. Vendors of LIS and LIMS have recognized not only the value of adding billing management to their solutions but also the many benefits that come with tying in diagnosis and billing code support. For example, a pathologist scanning a specimen into the system can not only have a case automatically generated but also auto-generate diagnosis codes based on the specimen or slide's code. Additionally, as has been witnessed during the COVID-19 pandemic, billing rules may change rapidly during extraordinary events, requiring rapid used-defined billing rule changes.[36] As such, support for CPT, ICD-10, SNOMED CT, and other types of autocoding are somewhat common in today's PIMS.[1][20][21][26]
  • reflex and adjunctive test reporting: Ensure that a PIMS is capable of feeding any adjunctive test results into the final report, along with the results from the primary tests. Using adjunctive HPV test results as an example, the report should optimally include details such as assay name, manufacturer, the HPV types it covers, results, and any applicable educational notes and suggestions.[5] Be careful with simple color-coding of results for interpretation, as they can be easily misinterpreted, including by the colorblind. A combination of symbol with color will help limit such misinterpretation.[3]
  • structured data entry: The concept of structured data entry (SDE) is relatively simple, but it may still get taken for granted. At its core, SDE is all about ensuring that entered data is based on a set of predefined conditions or rules, usually implemented through standardized forms with pre-determined drop-down and auto-populated fields.[37] This typically confers numerous advantages, including easier data entry, easier and more standardized reporting, decrease costs, improve translational research, and ensure better compatibility and integration across different information systems.[37][38] As such, some PIMS vendors like NovoPath and Orchard Software describe their solutions as having SDE elements such as enabling intelligent auto-loading of diagnosis and billing codes during case loading, allowing input fields to be required, and synoptic reporting support.[39][24]
  • synoptic reporting: Synoptic reporting involves a structured, pre-formatted "checklist" of clinically and morphologically relevant data elements that help make pathology reporting more efficient, uniform, and relevant to internal and external stakeholders. Another way to put this is that synoptic reporting is SDE applied to the pathology report, often based upon specific reporting protocols by professional or standards organizations like the College of American Pathologists (CAP).[20][39] Support for synoptic reporting methods is typical within PIMS solutions, including support for configurable templates that can be adapted to changing and custom reporting protocols.
  • correlative and consultive reporting: In the late 1930s, the concept of correlating pathology results with clinical observations (and pathology) was beginning to be addressed in student textbooks.[40] Today, the concept remains integral in medical practice and toxicologic study reporting.[41][42][43] On the clinical side, a pathologist may include the phrase "clinical correlation is recommended" and additional comments. And in some cases, a third-party pathology consultation, with their own respective comments, is involved with specimen analysis.[44] These correlative and consultive comments or reports play an important part in the overall final pathology report and should not be omitted, particularly if differing opinions are involved. Vendors such as Orchard Software, LigoLab, and Aspyra tout their solutions' ability to tie together multiple reports and comments across pathology disciplines and consultants into one concise report.[24][20][26]
  • CAP Cancer Reporting Protocol support: Previously mentioned was CAP and its reporting protocols. In particular, CAP has its Cancer Reporting Protocols, which the CAP describe as providing "guidelines for collecting the essential data elements for complete reporting of malignant tumors and optimal patient care."[45] In conjunction with its electronic Cancer Checklists (eCCs)[46], pathologists are able to integrate CAP cancer reporting protocols of tumors, resections, and select biopsies into their PIMS' workflow and ensure proper reporting outcomes. Some PIMS vendors (e.g., Orchard Software, LigoLab[24][20]) explicitly indicate their solution integrates CAP's eCC templates and reporting protocols into their solution.
  • annotated organ mapping: In the world of PIMS, organ mapping refers to the concept of placing location-specific diagnostic information from specimen analyses into an anatomical diagram, typically during reporting, to more clearly communicate the results of those analyses. PIMS vendor WebPathLab, Inc. demonstrates this concept well with its Auto Organ Map Module, which not only shows an organ map in the rport but also simplifies data entry for the pathologist using SDE.[47][48] They use the prostate as an example, and explain that "selecting the predetermined number of quadrants in the prostate [diagram], the system autopopulates the specimen description to each corresponding quadrant, and autofills the text for the Gross Description field, leaving only the dimension of each core to be entered by the grosser." NovoPath and Psyche Systems Corporation are additional examples of vendors incorporating organ mapping into their PIMS.[2][39]
  • stain panel and unstained/control slide support: A positive control slide is typically used to qualitatively assess how well a non-hematoxylin-eosin (non-H&E) or "special" stain performs against a gold standard like H&E, and the positive control is usually included with manufactured unstained slides (e.g., see Newcomer Supply's control slide catalog). These slides may be used in histopathology (gauging the manifestation of disease in a tissue) and immunopathology (gauging immune response through visualization of an antibody-antigen interaction in a tissue). In particular, immunopathology and its associated immunohistochemistry may turn to special stain panels, which utilize multiple immunochemical stains to visualize the presence of more than one biomarker expression at the same time.[49][50][51] Vendors like NovoPath and Integrated Business Solutions Group explicitly state their solution supports the management of these types of slides and stain panels.[39][52]
  • grossing support: In medical terms, the adjective "gross" means "visible without the aid of a microscope."[53] By extension, gross examination (i.e., grossing) involves a macroscopic visual assessment of a biospecimen before preparation for microscopy, in order to gleen diagnostic information. Grossing remains a valuable skill used in modern pathology.[54][55] Some PIMS provide a grossing menu for pathologists to scan in and include commentary about a gross examination of a specimen.[20]
  • high-risk patient follow-up: A 2015 study published in Annals of Family Medicine showed evidence that "patients with high clinical complexity and high risk of readmission" benefited from early outpatient follow-up.[56][57] The authors concluded : "Follow-up within seven days was associated with meaningful reductions in readmission risk for patients with multiple chronic conditions and a greater than 20% baseline risk of readmission, a group that represented 24% of discharged patients." Presumably some health care systems are synthesizing that information into their patient workflows, likely through some sort of scheduled event and alert in their primary informatics system, e.g., an electronic health record (EHR) system.[58] Though not common, at least one PIMS vendor—LigoLab, LLC—indicates their solution helps address high-risk patient follow-up, though it's not clear how.[20]
  • research animal support: Non-clinical pathology and toxicology laboratories assisting with research and evaluation studies may be handling non-human specimens or even live research animals. Additional data about these animals, animal groups, and animal tissues may need to be carefully documented as part of a study. As such, some solutions such as Instem's Provantis preclinical pathology solution are designed to record specific animal and group identifiers, animal cross-reference information, organ weight ratios, palpable mass diagnoses, and other attributes for reporting.[59]


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