Medical Test Sites (MTS) and CLIA Licensing

Frequently Asked Questions

What is a medical test site?

A medical test site is a facility or site, public or private, which analyzes materials derived from the human body for the purposes of health care, treatment, or screening. A medical test site does not mean a facility or site, including a residence, where a test approved for home use by the Federal Food and Drug Administration is used by an individual to test himself or herself without direct supervision or guidance by another and where this test is not part of a commercial transaction; or a facility or site performing tests solely for forensic purposes.

What is a medical test site license?

A medical test site license is a certification that allows a facility in Washington state to perform tests on a person for the purpose of diagnosis, treatment, or prevention of disease.

How do I know if my facility requires a medical test site license?

Facilities in Washington state that perform tests on materials derived from the human body for the purposes of health care, treatment, or screening are required by law to obtain a Washington Medical Test Site license. This includes facilities using point-of-care or rapid screening tests not in a traditional laboratory setting, such as schools, childcare facilities, correctional facilities, or long-term care facilities, including assisted living facilities, adult family homes, and enhanced services facilities. If an employee of the facility participates in any step of the testing process, including performing or interpreting a test, a medical test site license is required for the facility.
If you need assistance determining whether your facility needs a medical test site license, contact us vial email or call 360-236-4661.

When is a Medical Test Site license not needed?

A medical test site license is not needed for self-tests that are performed and interpreted by individuals on themselves or their children.
If you need assistance determining whether your facility needs a medical test site license, contact us via email or call 360-236-4661.

How do I know what kind of license I need?

The of type license you need depends on the type of testing that you perform in your office. The Medical Test Site (MTS) applications outline the testing you may perform under each license type.

How do I get a Clinical Laboratory Improvement Amendments number?

In Washington, you need to complete the MTS application, not the federal 116 form. We'll enter your laboratory data into the federal Clinical Laboratory Improvement Amendments (CLIA) database and obtain your CLIA number for you. Your CLIA number will be listed on your MTS license.

Do I need a license for a health fair/screening?

Yes, if you plan to perform laboratory testing at a health fair/screening in Washington State and don't already have an MTS license, contact the Medical Test Site Program office at 360-236-4661. Your phlebotomists must have a Washington State professional license, such as registered nurse, licensed practical nurse, physician, medical assistant, etc.

Do I need a Medical Test Site license to perform pre-employment drug screens?

No, if you're only doing pre-employment drug screens and no other laboratory testing (including waived tests), you do not need an MTS license. However, if you perform employee drug screens that are used to send an employee to a treatment program, then you must have an MTS license.

If I have offices at several different locations, may I have only one license or do I need a separate one for each location?

You may qualify for one license for different locations if you're a not-for-profit organization and you're only doing a total of 15 or less different waived, provider-performed microscopic procedures, or moderate complexity tests. If you perform high complexity testing, or if you have not been classified as a not-for-profit (federal 501(c)(3) tax determination letter), you must have a separate license at each facility where you perform testing.

If a hospital system performs testing in different locations, but it's part of the same campus or complex, all testing sites may be covered under the same license.

Do I need to complete the federal Centers for Medicare & Medicaid Services CLIA-116 application form to get a CLIA number in Washington?

No. The MTS licensure program is exempt from the Clinical Laboratory Improvement Amendments of 1988 (CLIA). You don't need to apply separately to the Centers for Medicare & Medicaid Services (CMS) for a CLIA number. Your MTS license will contain both your MTS license number and your CLIA number.

We're an out-of-state laboratory. Do I need a Medical Test Site license to perform lab testing for Washington residents?

If you're performing the actual testing in Washington State, then you do need to have an MTS license. If you're just performing lab testing on Washington residents at your out-of-state laboratory, you don't need an MTS license.

Do I need a license even if I don't bill for the test?

Yes. The MTS and CLIA rules require licensure of any site that performs testing on humans for the purpose of healthcare, treatment or screening. Billing for the test has nothing to do with whether or not you need a license.

What does accredited mean?

Accreditation organization means a public or private organization or agency approved by CMS as having standards consistent with federal law and regulation, and judged by the department to be equivalent to this chapter. You must submit documentation from the approved accrediting organization that you have applied with them with your Medical Test Site (MTS) accredited application form.

Note: If you don't want to be accredited and inspected by a private accreditation organization, complete the categorized MTS application.

May I complete the application online and pay with a credit card?

No. We currently don't have this option available. We only accept checks or money orders.

To what address shall I send my payment?

Department of Health
Revenue Section
P.O. Box 1099
Olympia, WA 98507-1099

Where do I mail my application?

You may find the mailing address for the different license application types on the upper left-hand corner of the application form. If you have questions, please call 360-236-4661.

If I have a Provider Performed Microscopy Procedures license, can anyone in the office perform the microscopic procedures?

No. To qualify for a Provider Performed Microscopy Procedures (PPMP) license only a licensed practitioner (physician, osteopath, podiatrist, advanced registered nurse practitioner, nurse midwife, physician assistant, naturopath or dentist) may perform those procedures in conjunction with a patient visit. If other personnel perform the microscopic procedures, you need a different category of license, depending on the number of tests performed per year. If other personnel perform the microscopic procedures, contact the Medical Test Site Program at 360-236-4661.

How do I make changes to my license?

Laboratories must notify the Medical Test Site Program of all changes 30 days prior to of the change.

Complete the forms to change information about your laboratory demographics (name, address, phone number, fax number), personnel (director, laboratory contact, etc.), test menu additions or deletions, and change of ownership (must submit a new MTS application).

What if I don't need my Medical Test Site license any longer?

If you closed the office or the site is no longer performing any testing, complete a Closure Request Form (PDF) or call 360-236-4661.

The director changed. How do I update the information?

You may complete a Credential Status Change Form. Please send the original to the address on the top left hand corner of the form.

What if we're moving in a couple of months, how do I let you know?

Complete a change of demographic information form and send it to the address indicated on the form.

Our practice is closing soon and it's time to renew my license, do I still need to renew my MTS license?

Please call us at 360-236-4661.