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| =4. Resources for selecting and implementing informatics solutions: Part 2: Other vendors and service providers=
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| Part 2 of this guide's resources chapters steps away from LIMS, LIS, and ELN and looks at more the diagnostic equipment and supplies available to laboratories, as well as some applicable EHR vendors should your clinical laboratory require one. Additionally, service providers able to help you with laboratory workflows, billing, and other aspects of clinical diagnostic and research labs are listed here.
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| ==4.1 Medical diagnostics instrumentation and equipment vendors==
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| ===4.1.1 CLIA-certified vendors===
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| Medical diagnostics laboratories perform various types of testing, including point-of-care testing. At least in the United States, the [[Clinical Laboratory Improvement Amendments]] (CLIA) test complexities, as determined by the U.S. Food & Drug Administration (FDA)<ref name="FDA_CLIA18">{{cite web |url=https://www.fda.gov/medical-devices/ivd-regulatory-assistance/clia-categorizations |title=CLIA Categorizations |author=U.S. Food & Drug Administration |date=25 February 2020 |accessdate=18 November 2021}}</ref>, and resulting public CLIA Database provide insight into the instrumentation and equipment vendors marketing equipment for diagnostic and research laboratories. While not a complete list of instrument and equipment vendors, the CLIA-approved vendor lists below make an excellent starting point for laboratories seeking to add to its testing inventory.
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| The following two tables list vendors verified to sell CLIA-waived instruments and/or test kits. CLIA-waived instruments and test kits are deemed as being simple to use and as having little chance in providing wrong [[information]] or harming someone. The vendors were pulled from the FDA's [https://www.fda.gov/medical-devices/medical-device-databases/clinical-laboratory-improvement-amendments-download-data downloadable CLIA file] from November 2021. The file was sorted to pull out the CLIA-waived devices, and then the vendors were researched to see if they still actively marketed the listed product(s). In some cases, the vendor listed on the FDA file was acquired by another company. If the associated products were still found to be marketed by the acquiring company, that company name was used. CLIA-waived device and test kit types are given as a general guide to what CLIA-waived items the vendor offers.
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| '''Note''': Do not assume that just because a vendor is listed here all of its offerings are CLIA-waived. Some of these vendors may also sell analyzers and tests that are CLIA-certified as moderate or complex, as well as a variety of other non-CLIA-certified solutions. Additionally, this listing does not name the specific CLIA-waived item(s). It is ultimately up to the potential buyer to verify with the vendor that a specific item is CLIA-waived before purchase.
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| {{Vendors of CLIA-waived items}}
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| The following is a list of additional vendors verified to offer CLIA-certified moderate or complex diagnostic instruments and/or test kits. The same methodology was used as above for CLIA-waived, with the exception of opting to not provide specifics about instrument and test types.
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| '''Note''': Most of these vendors sell analyzers and tests that are CLIA-certified moderate or complex. However, is ultimately up to the potential buyer to verify with the vendor an item's CLIA certification status before purchase.
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| {{Vendors of CLIA-certified moderate or complex items}}
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| ===4.1.2 Other vendors===
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| As previously mentioned, some vendors manufacturing and distributing medical diagnostic and research solutions don't get their instruments and tests CLIA certified in the U.S. It's beyond the scope of this guide to attempt to list them all, but a few representative examples include:
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| * [https://www.abacusdiagnostica.com/ Abacus Diagnostica Oy]
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| * [https://www.zeiss.com/meditec/int/home.html Carl Zeiss Meditec AG]
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| * [https://www.clonit.it/en/ Clonit SRL]
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| * [https://www.devyser.com/ Devyser AB]
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| * [https://www.diapro.it/ Dia.Pro Diagnostic Bioprobes Srl]
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| * [https://en.dynamiker.com/ Dynamiker Biotechnology (Tianjin) Co., Ltd.]
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| * [https://www.dynextechnologies.com/ Dynex Technologies, Inc.]
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| * [https://www.lifehealthmed.com/ EasyDx, Inc.]
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| * [http://entrogen.com/ EntroGen, Inc.]
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| * [https://www.eppendorf.com/US-en/ Eppendorf AG]
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| * [https://www.hitachi-hightech.com/global/ Hitachi High-Technologies Corporation]
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| * [http://www.htz.biz/index.htm HTZ Ltd.]
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| * [http://www.humasis.com/en/ Humasis Co., Ltd.]
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| * [https://www.virion-serion.de/en/ Institut Virion\Serion GmbH]
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| * [https://www.jeolusa.com/ JEOL USA, Inc.]
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| * [https://www.launchdiagnostics.com/ Launch Diagnostics Ltd.]
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| * [https://www.mt.com/us/en/home.html Mettler-Toledo International, Inc.]
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| * [http://www.mkldiagnostics.com/ MKL Diagnostics AB]
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| * [https://www.healthcare.nikon.com/en/ Nikon Corporation]
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| * [https://www.novatec-id.com/ NovaTec Immundiagnostica GmbH]
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| * [https://medical.olympusamerica.com/ Olympus Corporation of the Americas]
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| * [https://www.orgentec.com/en/ ORGENTEC Diagnostika GmbH]
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| * [https://www.pentaxmedical.com/ PENTAX Europe GmbH]
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| * [https://www.sartorius.com/ Sartorius AG]
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| * [https://www.shimadzu.com/ Shimadzu Corporation]
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| * [https://en.vircell.com/ Vircell SL]
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| * [https://www.waters.com/ Waters Corporation]
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| Also, see BioPharmGuy's [https://biopharmguy.com/links/company-by-location-diagnostics.php worldwide diagnostics companies, by location].
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| ==4.2 EHR vendors==
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| An [[electronic health record]] (EHR) is "defined as a longitudinal collection of electronic health information about individual patients and populations."<ref name="GunterTerryEHR">{{cite journal |title=The Emergence of National Electronic Health Record Architectures in the United States and Australia: Models, Costs, and Questions |author=Gunter, T.D.; Terry, N.P. |journal=Journal of Medical Internet Research |volume=7 |issue=1 |page=e3 |year=2005 |doi=10.2196/jmir.7.1.e3 |pmid=15829475 |pmc=PMC1550638}}</ref> It is a record in digital format that is theoretically capable of being shared across different health care settings. In some cases, this sharing can occur by way of network-connected enterprise-wide information systems and other [[information]] networks or exchanges.
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| In the United States, many EHRs have been certified by the Office of the National Coordinator's (ONC) Health IT Certification Program. Those certifications are based on "standards, implementation specifications and certification criteria adopted by the Secretary."<ref name="HITAbout19">{{cite web |url=https://www.healthit.gov/topic/certification-ehrs/about-onc-health-it-certification-program |title=About The ONC Health IT Certification Program |work=HealthIT.gov |author=Office of the National Coordinator for Health Information Technology |date=09 November 2021 |accessdate=19 November 2021}}</ref> The ONC's ''Certified Health IT Product List'' is an excellent resource for browsing EHR and [[electronic medical record]] (EMR) vendors. It can be found at [https://chpl.healthit.gov/#/search https://chpl.healthit.gov/]. One approach is to click the "Browse All' button, then on the new screen select "Certification Status" and uncheck "Suspended by ONC" and "Suspended by ONC-ACB." That will give you a list of active results. Of course, you can apply additional filters, compare products (including certification criteria and clinical quality measures), and download results.
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| ==4.3 Laboratory business intelligence (BI) and workflow solution vendors==
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| These vendors provide software solutions that provide optimization of and insight into the business processes of a laboratory, from revenue management and client interaction to compliance management and process analysis. Some companies such as Soft Computer and Sunquest provide an entire suite of applications, while others focus on specific aspects of running a medical or research laboratory. For additional insight into selecting a BI solution for the medical laboratory, see Arezou Taheri's 2014 open-access journal article ([https://web.archive.org/web/20200211025016/https://www.ijcttjournal.org/archives/ijctt-v16p127 HTML], [https://web.archive.org/web/20200211025017/http://www.ijcttjournal.org/Volume16/number-3/IJCTT-V16P127.pdf PDF]) on the subject. While dated, its list of key selection factors still largely remains relevant.
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| * [https://www.corelaboratory.abbott/us/en/offerings/brands/aliniq/aliniq-bis Abbott Laboratories, Inc.]
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| * [https://accumen.com/ Accumen, Inc.]
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| * [https://www.adsc.com/lab-software Advanced Data Systems Corporation]
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| * [https://www.advancedmd.com/specialties/laboratory/ AdvancedMD, Inc.]
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| * [http://attunelive.com/bi-solutions-for-labs/ Attune Technologies Pvt. Ltd.]
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| * [https://www.cgm.com/usa_en/products/lab-management-software/cgm-labnexus.html CompuGroup Medical AG]
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| * [https://www.hc1.com/solutions/operations-management/ hc1, Inc.]
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| * [https://www.orchardsoft.com/solutions/orchard-outreach/ Orchard Software Corporation]
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| * [https://proscia.com/ Proscia, Inc.]
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| * [https://www.quadax.com/laboratory-revenue-cycle-management-software-solutions-billing-services/ Quadax, Inc.]
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| * [https://www.armaninollp.com/software/microsoft-dynamics-gp/ Schillaci Computer Service, Inc.]
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| * [https://www.sisense.com/solutions/healthcare/ Sisense, Inc.]
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| * [https://www.softcomputer.com/products-services/outreach/ Soft Computer Consultants, Inc.]
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| * [https://softwarepoint.com/laboratories/laboratory-intelligence Software Point Oy]
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| * [https://www.sunquestinfo.com/software-and-services/psc-portal/ Sunquest Information Systems, Inc.]
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| * [https://www.xifin.com/solutions/business-intelligence XIFIN, Inc.]
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| ==4.4 Laboratory billing service providers==
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| These businesses are known to provide revenue management and improvement services to laboratories. Additionally, a handful of these businesses may also offer their own laboratory billing software solutions in addition to providing billing services.
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| * [https://www.adsc.com/laboratory-billing-services Advanced Data Systems Corporation]
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| * [https://ahsrcm.com/solutions/billing/ AdvantEdge Healthcare Solutions]
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| * [https://www.affinitybilling.com/ Affinity Billing, Inc.]
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| * [https://amcbillingservices.com/ AMC Billing Services, LLC]
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| * [https://apsmedbill.com/ APS Medical Billing, Inc.]
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| * [https://www.bikham.com/medical-laboratory-billing-services Bikham Information Technology Corporation]
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| * [https://www.changehealthcare.com/revenue-cycle-management/reimbursement-management/physician-revenue-cycle-services/clinical-labs Change Healthcare, Inc.]
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| * [https://claimcare.com/ ClaimCare, Inc.]
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| * [https://www.collaboratemd.com/collaboratemd-pricing/medical-billing-and-labs/ CollaborateMD, Inc.]
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| * [https://www.coronishealth.com/about/companies/lab-billing/ Coronis Health]
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| * [https://healthteqservices.com/ Healthteq Services, LLC]
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| * [https://medcaremso.com/ Medcare MSO, LLC]
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| * [https://www.medconverge.com/ MedConverge, LLC]
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| * [https://www.medsphere.com/who-we-serve/labs/ Medsphere Systems Corporation]
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| * [https://metropm.com/ MPM, Inc.]
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| * [https://www.sunshinebilling.com/ The Negotiators, LLC]
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| * [https://phoenixhcs.com/laboratory-billing/ Phoenix Healthcare Services, Inc.]
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| * [https://www.pgmbilling.com/ Physicians Group Management, LLC]
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| * [http://www.practisource.com/medical-and-lab-billing/ PractiSource, LLC]
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| * [https://www.quadax.com/laboratory-revenue-cycle-management-software-solutions-billing-services/ Quadax, Inc.]
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| * [https://questns.com/ Quest National Services, LLC]
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| * [http://rpmbilling.com/ RPM Billing, LLC]
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| * [https://www.softactics.com/ Softactics, Inc.]
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| ==4.5 Consultants==
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| {{LIMS, LIS, and laboratory}}
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| ==References==
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| {{Reflist}}
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