Consulting Services for Medical and Scientific Technologies

IVD Insights™ LabFile

  • What Makes Up the IVD Universe? +

    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
  • What Institution Types are Covered? +

    Get Data on These Institution Types

    • Ambulatory Surgery Center
    • Blood Bank
    • Cancer Center (NCI-designated centers which are not stand-alone hospitals)
    • Clinic/POL
      • Allergy
      • Behavioral Health
      • Cardiology
      • Dermatology
      • Emergency Care
      • Endocrinology
      • Fertility
      • Gastroenterology
      • Internal Medicine
      • Military/VA
      • Nephrology
      • Ob/Gyn
      • Oncology
      • Pain Management
      • Pediatrics
      • Public Health
      • Rheumatology
      • Unspecified (usually multi-specialty clinics, Family Practice or Primary Care)
      • Urgent Care
      • Urology
    • Federal, State or Local Government
      • Forensics and/or Toxicology
      • Prison
      • Other
    • Hospital (short-term, acute care)
      • Community (non-teaching)
      • Critical Access (25 beds or less)
      • Military / VA
      • Teaching (non-University affiliated)
      • University (teaching, usually associated with a specific medical school)
    • Independent
      • Anatomic Pathology
      • Anatomic Pathology/Molecular
      • Coagulation
      • Contract Research Organization
      • Cytology/Cytopathology
      • Dermatopathology
      • Forensics and/or Toxicology
      • Genetics
      • Healthcare System Laboratory
      • Limited Reference (restricted menu, usually serves nursing homes and home healthcare providers)
      • Microbiology
      • National Reference
      • Oncology
      • Patient Service Center
      • Proprietary Assays
      • Regional Reference
      • Research
      • Specialty Reference (usually Esoteric testing not restricted to one of the other sub-types)
    • Public Health
    • Tissue/Cell Bank (includes Plasma Fractionation labs)
    • Other
      • Academic
      • Association
      • Behavioral Health
      • Home Care
      • LTAC
      • Pediatric (LTAC or Rehabilitation)
      • Rehabilitation
  • CRM Services +

    LabFile Aids CRM Activities

    Whether you’re a new business building a target list or an established organization looking to optimize your CRM data, IVD Insights LabFile is the definitive source for the most accurate information currently available on U.S. clinical laboratories. LabFile reports can be used to determine true market potential, reallocate sales organizations, and keep current with industry consolidation. You can confirm who your customers are and supplement that knowledge with valuable context.

    MDxI provides tailored census data to clients. Our SalesForce SFDC certified staff offers consulting and analyses in architecture, planning, implementation, and troubleshooting services to help you:
    • Determine what data you need
    • Make sense of the information
    • Develop plans to apply learnings to your organization’s needs

    CRM Reconciliation

    To reconcile your CRM to the LabFile IVD Universe, MDxI associates various information – physical address, bill to, ship to, specific lab, other – with a unique identifier by institution. These institutions can then be consolidated into parent healthcare delivery or laboratory systems by another unique identifier. Moreover, the level of detail provided by LabFile enables MDxI to identify those laboratories within major health systems that consolidate testing from other hospitals and delivery sites within that system.

    Because MDxI provides LabFile updates quarterly, you can reduce or eliminate internal resources dedicated to those updates and maintain a very accurate database of clinical labs. If you are entering a new market, you can create databases from LabFile that target only those labs requiring your product or service.

  • Market Segmentation +

    MDxI can help you integrate advanced Market Segmentation tools into your CRM based on our extensive knowledge of the IVD Universe, our other syndicated data services, and our proprietary research and consulting experience.

    Once your CRM records have been linked to MDxI’s IVD Insights LabFile data, we can populate your CRM with valuable data from our other databases to help target customers with detailed context. For example, we can add information on the testing menus and instrument portfolios of each institution, including an indicator of when certain instruments are likely to be replaced. With this knowledge, you can more effectively target marketing efforts to engage those labs performing relevant assays, as well as those likely to be entering a new capital acquisition process. 
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IVD Insights™ LabFile

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