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.
- Waived Application Helpful Tips and Instructions (PDF)
- Complete the Certificate of Waiver MTS/CLIA license application (PDF).
- Review the CDC Ready? Set? Test! Booklet for best practices in waived testing.
- Good Laboratory Practices with Waived Test Systems (PPT) - self-study PowerPoint presentation
- Contact the Laboratory Quality Assurance (LQA) office at 253-395-6746 if you need help determining what classification of testing you perform.
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.
- Complete the PPMP MTS/CLIA license application (PDF).
- Review the CDC Ready? Set? Test! Booklet for best practices in waived testing.
- Review the CDC Provider Performed Microscopy Procedures Booklet for best practices in PPMP testing.
- Contact the LQA office at 253-395-6746 if you need help determining what classification of testing you perform.
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.
- Complete the categorized MTS/CLIA license application (PDF).
- Contact the LQA office at 253-395-6746 if you need help determining what classification of testing you perform.
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:
- A2LA (American Association for Laboratory Accreditation)
- AABB (American Association of Blood Banks)
- AOA (American Osteopathic Association)
- ASHI (American Society of Histocompatability and Immunogenetics)
- CAP (College of American Pathologists)
- COLA
- The Joint Commission
Specific personnel requirements apply to the accredited MTS/CLIA license based upon the type of testing performed.
- Complete the accredited MTS/CLIA license application (PDF).
- Contact the LQA office at 253-395-6746 if you need help determining what classification of testing you perform.
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.