Consulting Services for Medical and Scientific Technologies

Why LabFile

LabFile accurately defines the IVD Universe

MDxI defines each institution listed in LabFile as a unique organization in a distinct physical location with one or more laboratories that, under CLIA regulations, must be licensed for clinical laboratory testing by the U.S. Centers for Medicare and Medicaid Services (CMS). Each institution may operate as an independent enterprise or be part of a larger healthcare delivery or laboratory organization.

By more accurately identifying the IVD Universe, LabFile distinguishes fully functional labs from patient service centers that primarily collect patient specimens but may also perform limited lab testing. The database provides insight into laboratory location, affiliates, specialty where known, and more, as well as a breakdown of clinical labs by institution type.

MDxI is continuously adding and updating relevant sites to LabFile, and as of March 2018 had verified detailed information for over 23,000 institutions. These institutions have been categorized as one of 10 types of institutions and 66 sub-types by specialty and ownership.

Issues with Relying on Only CLIA License Data to Define the Clinical Laboratory Universe

  • Over-counting labs due to multiple CLIA licenses held by a single enterprise or laboratory location

    MDxI currently counts 33 U.S. hospitals with more than 10 CLIA licenses each. In total, these 33 laboratory sites could be miscounted as equaling 559 potential customers.

  • Inaccuracy of CLIA laboratory designations

    The current CLIA license application allows laboratories to self-classify as one of 29 different types of laboratories, each presented without a definition and not reviewed for accuracy. The result is that many physician office laboratories mistakenly designate themselves as independent laboratories, as do hospital laboratories that may be operated by a third party organization.

  • Licensed sites performing waived-testing only are not identified as such

    Laboratories performing waived testing must obtain a certificate of waiver (CW), while those conducting non-waived PPM must obtain a certificate for PPM procedures. Laboratories conducting other non-waived testing must obtain a certificate of compliance (COC) following inspection or a certificate of accreditation (COA) from a CMS-approved private sector accreditation organization.

    LabFile is currently focused only on those sites that perform non-waived testing, although we plan to add and properly label these sites as time permits.

  • Inaccurate information (i.e. lab specialty, volume)

    Laboratory specialties and testing categories reported under CLIA regulations are verified, to the extent possible, by MDxI’s review of each site’s actual participation in CMS-approved proficiency testing programs

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IVD Insights™ LabFile

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