Laboratory Quality Assurance

 

Applications

License Types, Requirements, and Applications

The type of testing performed determines the MTS/CLIA license category. Select from the following four options:

Please note: All applications require an original ink signature to be processed.

Waived Medical Test Site License Toolkit and Application

Only tests approved as waived by the Food and Drug Administration (FDA) can be performed under this category of license.

If your test kit doesn't appear on the FDA-approved waived test list, you DO NOT qualify for this license type. See the categorized or accredited license information below.

PPMP – Provider Performed Microscopic Procedure

Under this category of license, the facility can perform all CLIA waived tests and the nine approved microscopic procedures (PDF), if performed only by the following people:

  • MD (medical doctor)
  • DO (doctor of osteopathy)
  • DPM (doctor of podiatric medicine)
  • ARNP (advanced registered nurse practitioner)
  • Midwife
  • PA (physician assistant)
  • Naturopath
  • Dentist

If personnel other than those listed above perform the microscopic tests, you DO NOT qualify for this category of license. See the categorized or accredited license information below.

Categorized

Please note: The facility can perform tests the FDA classifies tests as either moderate or high complexity.

Inspection will be performed by Department of Health Laboratory Quality Assurance (LQA) surveyors.

Specific personnel requirements apply to the categorized MTS/CLIA license based upon the type of testing performed.

Accredited

Please note: The facility can perform tests the FDA classifies tests as either moderate or high complexity.

Inspection will be performed by accreditation organization surveyors.You must apply to one of the following approved private accreditation organizations to monitor and inspect your facility:

Specific personnel requirements apply to the accredited MTS/CLIA license based upon the type of testing performed.

NOTE: If you don't want to be accredited and inspected by a private accreditation organization, follow the categorized MTS/CLIA license application instructions above.

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