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| | text = This is sublevel1 of my sandbox, where I play with features and test MediaWiki code. If you wish to leave a comment for me, please see [[User_talk:Shawndouglas|my discussion page]] instead.<p></p> | | | text = This is my primary sandbox page, where I play with features and test MediaWiki code. If you wish to leave a comment for me, please see [[User_talk:Shawndouglas|my discussion page]] instead.<p></p> |
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| ==Sandbox begins below== | | ==Sandbox begins below== |
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| ===Broad feature set of a pathology information management solution===
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| A pathology information management solution (PIMS) ...
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| * '''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="NovoPathSoftware13">{{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>
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| * '''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" />:
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| <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>
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| :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).
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| * '''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>:
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| <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>
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| :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>
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| * '''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>
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| * '''case management and review''': Case history
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| * '''speech recognition and transcription management''':
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| * '''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>
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| * '''task management''': Case assignment
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| * '''billing management with code support''': Support for CPT, ICD-10, SNOMED, etc. codes, auto-generation of those codes based on specimen/slide code, automated billing, user-defined billing rules
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| * '''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" />
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| * '''correlation reporting''':
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| * '''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>
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| * '''synoptic reporting''':
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| * '''consultive reporting''':
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| * '''CAP Cancer Reporting Protocol support''':
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| * '''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 [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." Psyche Systems Corporation is another example of a vendor putting organ mapping into their PIMS.<ref name="PsycheWindo">{{cite web |url=https://psychesystems.com/enterprise-laboratory-information-software/windopath/ |title=WindoPath Ē.ssential |publisher=Psche Systems Corporation |accessdate=23 September 2020}}</ref>
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| * '''stain panel and unstained/control slide support''':
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| * '''grossing support''':
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| * '''testing protocol and workflow design''':
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| * '''high-risk patient follow-up''':
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| * '''research animal support''':
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| ==References==
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| {{Reflist|colwidth=30em}}
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