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.
Forms
Select the appropriate form to make updates to your existing license.
Application
When applying for MTS licensure, the type of tests you will perform determine the type of license required to conduct testing. Review the four types of MTS licenses available below.
Contact the MTS Program if you need help determining your classification of testing or licensure.
Complete the Medical Test Site Application Packet (PDF).
Waived Medical Test Site License
Choose this option if you will perform tests classified as waived by the Food and Drug Administration (FDA).
Provider Performed Microscopic Procedures (PPMP) Medical Test Site License
Choose this option if a licensed physician, dentist, advanced registered nurse practitioner, or physician assistant will perform any of the nine approved microscopic procedures (PDF).
Anyone within your facility may perform tests classified as waived by the FDA under this license type.
Categorized Medical Test Site License
Choose this option if you will perform tests classified as moderate or high complexity by the FDA. You may also perform waived tests.
Specific personnel requirements apply based upon the type of testing performed.
Inspections will be performed by Department of Health Medical Test Sites (MTS) surveyors.
Accredited Medical Test Site License
Choose this option if you will perform tests classified as moderate or high complexity by the FDA. You may also perform waived tests.
Specific personnel requirements apply based upon the type of testing performed.
Inspections will be performed by accreditation organization surveyors. You must separately apply to one of the approved 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 Histocompatibility and Immunogenetics)
- CAP (College of American Pathologists)
- COLA (Commission on Laboratory Accreditation)
- Joint Commission
Fees
The medical test site current fees can be found at WAC 246-338-990.