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3. Additional resources for selecting and implementing informatics solutions - Part 2: Other vendors and service providers
3.2 Medical diagnostics instrumentation and equipment vendors
3.2.1 CLIA-certified vendors
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)[1], 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.
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 downloadable CLIA file from January 2020. 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.
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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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.
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.
3.2.2 Other vendors
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:
- Abacus Diagnostica Oy
- Carl Zeiss Meditec AG
- Devyser AB
- Dia.Pro Diagnostic Bioprobes Srl
- Dynamiker Biotechnology (Tianjin) Co., Ltd.
- Dynex Technologies, Inc.
- EasyDx, Inc.
- EntroGen, Inc.
- Eppendorf AG
- Euroclone Diagnostica Srl
- Fast Track Diagnostics Luxembourg Sàrl
- Hitachi High-Technologies Corporation
- HTZ Ltd.
- Humasis Co., Ltd.
- Institut Virion\Serion GmbH
- JEOL USA, Inc.
- Launch Diagnostics Ltd.
- Mettler-Toledo International, Inc.
- MKL Diagnostics AB
- Nikon Corporation
- NovaTec Immundiagnostica GmbH
- Olympus Corporation of the Americas
- ORGENTEC Diagnostika GmbH
- PENTAX Europe GmbH
- Sartorius AG
- Shimadzu Corporation
- Vircell SL
- Waters Corporation
Also, see BioPharmGuy's worldwide diagnostics companies, by location.
3.3 EHR vendors
An electronic health record (EHR) is "defined as a longitudinal collection of electronic health information about individual patients and populations."[2] 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.
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."[3] 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/. 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.
3.4 Laboratory workflow and business intelligence solution vendors
- Abbott Laboratories, Inc.
- Advanced Data Systems Corporation
- AdvancedMD, Inc.
- Attune Technologies Pvt. Ltd.
- hc1, Inc.
- Sisense, Inc.
- Soft Computer Consultants, Inc.
- Software Point Oy
- Sunquest Information Systems, Inc.
- XIFIN, Inc.
3.5 Laboratory billing service providers
- Advanced Data Systems Corporation
- Affinity Billing, Inc.
- AMC Billing Services, LLC
- Bikham Information Technology Corporation
- Change Healthcare, Inc.
- ClaimCare, Inc.
- CollaborateMD, Inc.
- Healthteq Services, LLC
- Infallibill Corp.
- Laboratory Billing Solutions, Inc.
- Laboratory Experts, LLC
- Medcare MSO, LLC
- MedConverge, LLC
- MPM, Inc.
- The Negotiators, LLC
- Phoenix Healthcare Services, Inc.
- Physicians Group Management, LLC
- Physicians' Service Center, Inc.
- PractiSource, LLC
- Quadax, Inc.
- Quest National Services, LLC
- RPM Billing, LLC
- Softactics, Inc.
- TELCOR, Inc.
References
- ↑ U.S. Food & Drug Administration (22 March 2018). "CLIA Categorizations". https://www.fda.gov/medical-devices/ivd-regulatory-assistance/clia-categorizations. Retrieved 20 January 2020.
- ↑ Gunter, T.D.; Terry, N.P. (2005). "The Emergence of National Electronic Health Record Architectures in the United States and Australia: Models, Costs, and Questions". Journal of Medical Internet Research 7 (1): e3. doi:10.2196/jmir.7.1.e3. PMC PMC1550638. PMID 15829475. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1550638.
- ↑ Office of the National Coordinator for Health Information Technology (27 March 2019). "About The ONC Health IT Certification Program". HealthIT.gov. https://www.healthit.gov/topic/certification-ehrs/about-onc-health-it-certification-program. Retrieved 20 January 2020.
