Medical Test Sites (MTS) Licensing Info, Forms, and Fees

The Washington Medical Test Site (MTS) licensure program is exempt from the Clinical Laboratory Improvement Amendments of 1988 (CLIA). You don't need to apply to Centers for Medicare & Medicaid Services (CMS) for a CLIA number. Your MTS license will contain both your MTS license number and your CLIA number.

Good Laboratory Practices

• 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 
• Review the CDC Provider Preformed Microscopy Procedures Booklet for best practices in PPMP testing.

Laboratory Director Responsibilities

• Review the Laboratory Director Responsibilities guidance provided by CLIA (PDF). Washington state enforces the same minimum requirements for laboratory directors.

Applications and Forms

License Types

The type of testing performed determines the MTS/CLIA license category. Select from the following four options: Waived, PPMP, Categorized or Accredited: 

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

MTS/CLIA Application Decision Tree

To determine which type of MTS license to apply for, first determine if your facility will perform waived, moderate or high complexity tests. You can verify what type of test you are using by searching the test categorization database.

A list of commonly used waived tests is available. If your lab will perform waived complexity tests only, please submit the waived medical test site license.

A list of provider performed microscopic procedures (PPMP) (PDF) is available. These tests must be performed only by a physician, dentist, physician assistant or advanced registered nurse practitioner in conjunction with a patient visit. If your lab will perform waived tests and the PPM procedures, please submit the PPMP medical test site license.

If your lab plans to use moderate or high complexity tests, please submit either the categorized or accredited medical test site license. Under these license types, your facility can also perform waived tests.

• If you submit the categorized license application, your facility will be inspected by the Medical Test Site program surveyors.
• If you submit the accredited license application, your facility will be inspected by the accrediting agency that you choose. You will need to send a separate application to your accrediting agency.

Contact the MTS Program at 360-236-4661 if you need help determining what classification of testing you perform.

Waived Medical Test Site License

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. Instead, please apply for a categorized or accredited license.

• Complete the Certificate of Waiver MTS/CLIA license application (PDF). 
• Waived Application Helpful Tips and Instructions (PDF) 

Provider Performed Microscopic Procedures (PPMP) Medical Test Site

Under this category of license, the facility can perform all CLIA waived tests and  nine approved microscopic procedures (PDF), if performed only by a physician, dentist, ARNP (advanced registered nurse practitioner) or physician assistant (PA).

If licensed healthcare professionals other than those listed above perform the microscopic tests, you DO NOT qualify for this category of license. Instead, please apply for a categorized or accredited license.

• Complete the PPMP MTS/CLIA license application (PDF). 

Categorized Medical Test Site License

The facility can perform tests the FDA classifies as either moderate or high complexity in addition to waived tests. 

Inspections will be performed by Department of Health Medical Test Sites (MTS) 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). 

Accredited Medical Test Site License

The facility can perform tests the FDA classifies as either moderate or high complexity in addition to waived tests.

Inspections 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: 

• ACHC (Accreditation Commission for Health Care)
• A2LA (American Association for Laboratory Accreditation) 
• AABB (Association for the Advancement of Blood & Biotherapies) 
• 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). 
• 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. 

Forms

• Update address, facility name, or personnel: Credential status change form (PDF) 
• Add or remove additional test sites: Multiple Test Sites and Temporary Test Sites Request Form (PDF)
• Ownership change: Complete a new MTS application 
• Add or delete tests for your license or update volumes: Test menu change form (PDF) 
• Close a Medical Test Site: Closure Request Form (PDF)
• Waived and PPMP Tests (Fillable PDF) This form isn't fillable in Microsoft Edge. We recommend using Chrome or Firefox.
• Non-Waived and Non-PPMP Tests (Fillable PDF)
• Personnel Qualification Requirements (PDF)

Fees

The Medical Test Site current fees can be found at WAC 246-338-990.