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4. Resources for selecting and implementing informatics solutions: Part 2: Other vendors and service providers
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.
4.1 Medical diagnostics instrumentation and equipment vendors
4.1.1 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 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.
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.
4.1.2 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
- Clonit SRL
- Devyser AB
- Dia.Pro Diagnostic Bioprobes Srl
- Dynamiker Biotechnology (Tianjin) Co., Ltd.
- Dynex Technologies, Inc.
- EasyDx, Inc.
- EntroGen, Inc.
- Eppendorf AG
- 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.
4.2 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.
4.3 Laboratory business intelligence (BI) and workflow solution vendors
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 (HTML, PDF) on the subject. While dated, its list of key selection factors still largely remains relevant.
- Abbott Laboratories, Inc.
- Accumen, Inc.
- Advanced Data Systems Corporation
- AdvancedMD, Inc.
- Attune Technologies Pvt. Ltd.
- CompuGroup Medical AG
- hc1, Inc.
- Orchard Software Corporation
- Proscia, Inc.
- Quadax, Inc.
- Schillaci Computer Service, Inc.
- Sisense, Inc.
- Soft Computer Consultants, Inc.
- Software Point Oy
- Sunquest Information Systems, Inc.
- XIFIN, Inc.
4.4 Laboratory billing service providers
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.
- Advanced Data Systems Corporation
- AdvantEdge Healthcare Solutions
- Affinity Billing, Inc.
- AMC Billing Services, LLC
- APS Medical Billing, Inc.
- Bikham Information Technology Corporation
- Change Healthcare, Inc.
- ClaimCare, Inc.
- CollaborateMD, Inc.
- Coronis Health
- Healthteq Services, LLC
- Medcare MSO, LLC
- MedConverge, LLC
- Medsphere Systems Corporation
- MPM, Inc.
- The Negotiators, LLC
- Phoenix Healthcare Services, Inc.
- Physicians Group Management, LLC
- PractiSource, LLC
- Quadax, Inc.
- Quest National Services, LLC
- RPM Billing, LLC
- Softactics, Inc.
4.5 Consultants
These consultancies seem to focus primarily on helping others plan, choose, and implement an informatics system for the laboratory, though they may offer other services to laboratories, such as computer system validation (CSV), project management, and workflow development. (The location represents the entity's headquarters.)
| Vendor | Headquarters | Key services | Services page |
|---|---|---|---|
| A Byte of Advice, Inc. | Fairfield, IL, U.S. | "We provide project management, system development, code modification, support and training"; experience with LabVantage and PerkinElmer products |
Services page |
| A2LA Workplace Training | Frederick, MD, U.S. | LIMS, quality management systems, regulatory compliance assessments, process and risk management, etc. | Services page |
| ABB Ltd. | Zurich, Switzerland | Provides an expansive set of services. | Services page |
| Accenture PLC | Dublin, Ireland | Laboratory informatics, LIMS, LIS, ELN, data analytics, managed services, etc. | Services page |
| AKKA Technologies Group | Brussels, Belgium | Information technology, engineering, clinical data management, regulatory affairs and compliance, etc. | Services page |
| Astrix, Inc. | Red Bank, NJ, U.S. | "Astrix’s core competency is to assist organizations in the development and implementation of data management strategies to enhance the collection, processing, analysis and reporting of scientific data." |
Services page |
| Avellana Learning Oy | Vantaa, Finland | LIMS, LIS, and ELN implementation; open-source software implementation; software validation; quality control | Services page |
| BC Solutions, LLC | Phoenix, AZ, U.S. | LIS implementation, interface testing and validation, project management and consulting, data conversion/migration |
Services page |
| BGASoft, Inc. dba LIMS ABC | Fort Lauderdale, FL, U.S. | Business analysis, lab process improvement, enterprise and cloud architecture, LIMS implementation, etc. | Services page |
| Bika Lab Systems (Pty) Ltd. | Western Cape, South Africa | LIMS requirement analysis, design, customization, configuration, and testing; training; project management, etc. | Services page |
| Bottom Line Consulting, LLC | Endwell, NY, U.S. | LabWare products, user requirements specifications, vendor selection, project management | Services page |
| Brevitas Consulting, Inc. | Sacramento, CA, U.S. | LabWare products, LIMS implementation; project management; quality assurance, etc. | Services page |
| C4 Database Management, Inc. | Port Orchard, WA, U.S. | LIS administration, LIS integrity, data integrity, database installation and migration | Services page |
| Chemtech Servicos de Engenharia e Software Ltda. | Rio de Janeiro, Brazil | Manufacturing execution systems, SCADA, automation, cyber security, etc. | Services page |
| Clarity Compliance Solutions Limited | Chepstow, Wales | LIMS, system validation, data integrity, process mapping, vendor selection, etc. | Services page |
| Clarkston Consulting | Durham, NC, U.S. | LIMS, data integrity, process mapping, vendor selection, quality management, project management etc. | Services page |
| Clevr | Newstead, QLD, Australia | Laboratory process and technology consultations, custom LIMS development | Services page |
| Clinical Lab Consulting, LLC | Dublin, OH, U.S. | Provides a wide range of services "to all types of clinical laboratories including governmental, academia, hospital, reference and physician office laboratories." |
Services page |
| Clinical Laboratory Consultants dba Medical Source | Marietta, GA, U.S. | "Medical Source offers experience, guidance, and unmatched expertise in the physician office and independent reference laboratory." |
Services page |
| Cosine Consultants Ltd. | Strovolos, Cyprus | Software customization, data management system consulting, Fission LIMS, etc. | Services page |
| CSols, Inc. | Newark, DE, U.S. | Laboratory informatics strategic services, ELN and LIMS implementation, computer system validation, and laboratory vendor-specific technologies |
Services page |
| Digital Lab Consulting Ltd. | London, U.K. | LIMS, LIS, and ELN implementation; computer system validation; business case development; requirements definition; project management; vendor selection; etc. |
Services page |
| e-Science Solutions Ltd | Whittington, U.K. | Information technology, business case development, requirements definition, vendor selection, etc. | Services page |
| EM2 Solutions, Inc. dba Labtopia | Houston, TX, U.S. | Laboratory informatics strategic services, LIMS implementation, computer system validation, quality management systems, training, and staffing |
Services page |
| Engineering Industries eXcellence | Chicago, IL, U.S. | LIMS selection, implementation, and change management; lab automation; and more | Services page |
| Excelra | Boston, MA, U.S. | LIMS and ELN selection, implementation, and change management; workflow optimization; program and project management; data migration and integration |
Services page |
| EquixTech | Madrid, Spain | LIMS selection, implementation, and change management; manufacturing execution systems; automation; industrial internet of things |
Services page |
| Fructeam SARL | Paris, France | eLearning tools, clinical trial management systems, LIMS, ELN, SDMS, SAP | Services page |
| HPFM, Inc. | Pacifica, CA, U.S. | LIMS selection, implementation, and change management; computer system validation; quality management systems, etc. |
Services page |
| iConnect Consulting, Inc. | San Francisco, CA, U.S. | LIMS implementation and validation; computer system validation; HL7 electronic communication, training | Services page |
| IMCOR GmbH | Filderstadt, Germany | LIMS selection and implementation, computer system validation, business process analysis and optimization | Services page |
| InfoWiz | Anyang, Gyeonggi, South Korea | LIMS, LES, ELN, SDMS, and quality management system selection and implementation; system integration | Services page |
| Kainos Healthcare Solutions, LLC | Richmond, VA, U.S. | Laboratory informatics, LIMS, LIS, EHR, EMR, quality control, procurement and implementation, custom development; they also offer a laboratory quality management solution, eQCo |
Services page |
| Kalleid, Inc. | Cambridge, MA, U.S. | "We work across the value chain in R&D, clinical and quality areas to deliver support services for software implementations in highly complex, multi-site organizations." |
Services page |
| Lab Insights, LLC | Carlsbad, CA, U.S. | Laboratory informatics, computer system validation, vendor assessment, HIPAA audits and training, quality assurance, process improvement, etc. |
Services page |
| Lab-Lims Consulting BV | Lokeren, Belgium | Laboratory informatics, LIMS optimization, laboratory optimization | Services page |
| LabMetrics, LLC | Ishpeming, MI, U.S. | Laboratory informatics, automation, instrumentation, compliance and auditing, quality assurance, etc. | Services page |
| Laboratory Advisory Bureau, LLC | McAllen, TX, U.S. | Clinical laboratory informatics, LIS, quality assurance, compliance and auditing, workflow management, etc. | Services page |
| Laboratory Systems Consulting | Celbridge, Ireland | Laboratory and scientific informatics, 21 CFR Part 11, project management, etc. | Services page |
| LIMeS Lab Support | Netherlands | Laboratory informatics, LIMS, LES, ELN, SDMS, lab automation | Services page |
| LIMS4U | Bedworth, England | Laboratory informatics, LIMS | Services page |
| LIMSCON | Vienna, Austria | Laboratory informatics, LIMS, ELN, CDMS, document management, training, project management, computer system validation, etc. |
Services page |
| LUFC LabConsultants | Mierlo, The Netherlands | Laboratory informatics, LIMS, ELN, CDMS, SDMS, vendor selection, computer system validation, workflows, project management, lab management, etc. |
Services page |
| Nichols Management Group Ltd. | York Harbor, ME, U.S. | Clinical laboratory informatics, system assessment, implementation, and integration; project management; workflow management, etc. |
Services page |
| NNIT A/S | Søborg, Denmark | Laboratory informatics; system assessment, implementation, and integration; system validation; project management; workflow management; etc. |
Services page |
| Nous Labautomation Support | Mariaheide, Netherlands | Laboratory process, automation, and regulation assistance; project management; LIMS, ELN, CDS, and document management system implementation |
Services page |
| NXG Group, Inc. | Chennai, India | Laboratory informatics, LIMS, testing and validation, system integration management, business consulting, etc. |
Services page |
| Orbis Labsystems Ltd. | Dublin, Ireland | Laboratory informatics, LIMS, quality assurance, system integration management, automation, etc. | Services page |
| OSTHUS GmbH | Aachen, Germany | Laboratory informatics, LIMS, system integration management, business consulting, etc. | Services page |
| prime4services GmbH | Karlsruhe, Germany | LIMS, project management, vendor selection, quality management and validation, etc. | Services page |
| PQE Group - Europe | Florence, Italy | Laboratory informatics, LIMS, laboratory instrument management, method validation, project management, etc. | Services page |
| PQE Group - North America | Rockville, MD, U.S. | Laboratory informatics, LIMS, laboratory instrument management, method validation, project management, etc. | Services page |
| RC Inspection Group | Rotterdam, Netherlands | Laboratory informatics, LIMS, data analysis, automation, etc. | Services page |
| RevereIT, LLC | Sterling, VA, U.S. | LIMS, system integration management, system validation, method development and validation, data migration, vendor selection, etc. |
Services page |
| Sagit Solutions Ltd. | Wan Chai, Hong Kong | LIMS, implementation management, cloud management, vendor selection, etc. | Services page |
| Scimcon Limited | Newmarket, Suffolk, U.K. | Laboratory informatics, LIMS, ELN, CDS, SDMS, instrument management, project management | Services page |
| Semaphore Solutions, Inc. | Victoria, B.C., Canada | Laboratory informatics, LIMS, BaseSpace Clarity LIMS, workflow development, genomics | Services page |
| Sequence, Inc. | Morrisville, NC, U.S. | Laboratory informatics, LIMS, ELN, CDS, SDMS, data architecture analysis, data analytics | Services page |
| Shaw Informatics Ltd. | Horsham, West Sussex, U.K. | Laboratory informatics, LIMS, LES, ELN, process mapping, requirements analysis, project management, vendor selection, deployment strategy, knowledge management solutions, training |
Services page |
| Silver Lining Informatics, LLC | Brooklyn, NY, U.S. | Laboratory informatics, LIMS, LES, ELN, LabWare products, STARLIMS products, LabVantage products, workflow development, reporting, project management, training |
Services page |
| SoftNLabs SpA | Croix, France | Laboratory informatics, LIMS, ELN, LES, SDMS, ERP, CRM, project management, software validation | Services page |
| SoftFormance | Tallinn, Estonia | Laboratory informatics, LIMS, ELN, LES, SDMS, ERP, CRM, data migration and synchronization | Services page |
| Solution4Labs Sp. z o.o. | Białystok, Poland | Laboratory informatics, LIMS, ELN, custom development, Thermo Scientific products, Agaram Technologies products, etc. |
Services page |
| Techsol Corporation | Princeton, NJ, U.S. | LIMS, QMS, MES, regulatory affairs, clinical development, software validation, analytics, etc. | Services page |
| The Thor Group | Redondo Beach, CA, U.S. | LIS, RIS, EHR optimization and implementation | Services page |
| Validation Systems, Inc. | Palo Alto, CA, U.S. | Laboratory informatics, microbiological and chemistry services, quality management systems, computer system validation, etc. |
Services page |
| Verista | Fishers, IN, U.S. | Laboratory informatics, LIMS, ELN, CDS, laboratory compliance assessments, computer system validation, project management, etc. |
Services page |
| wega Informatik AG | Basel, Switzerland | LIMS, data management systems design and implementation, clinical trial management systems, and electronic data capture for life and chemical sciences |
Services page |
References
- ↑ U.S. Food & Drug Administration (25 February 2020). "CLIA Categorizations". https://www.fda.gov/medical-devices/ivd-regulatory-assistance/clia-categorizations. Retrieved 18 November 2021.
- ↑ 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 (9 November 2021). "About The ONC Health IT Certification Program". HealthIT.gov. https://www.healthit.gov/topic/certification-ehrs/about-onc-health-it-certification-program. Retrieved 19 November 2021.
