Frequently Asked Questions

General | MTS and CLIA Licensing | Proficiency Testing | Surveys/Inspections

General information

When may I start billing for testing?

Once you received a copy of the Medical Test Site (MTS) license, you may start billing for laboratory testing as of the "effective" date indicated on the license.

Our insurance carrier wants a copy of my Clinical Laboratory Improvement Amendments certificate. How do I get a copy?

Since Washington is a Clinical Laboratory Improvement Amendments (CLIA) exempt state, laboratories don't receive a separate CLIA certificate. The CLIA number appears on the MTS license. The MTS license is your CLIA certificate, so make a copy and send that to your insurance carrier or other labs that are requesting a copy.

I am a certified phlebotomist. Do I need a license in Washington?

Anyone in Washington doing an invasive procedure such as phlebotomy must have a medical assistant certification as long as they don't already have a healthcare professional license such as RN, LPN, MD, etc.

Whom do I call with questions?

Call the Medical Test Site Program for information about the MTS licensing program at 360-236-4661.

How does my doctor qualify to be director?

The qualifications for a director vary with the type of MTS license. Refer to the MTS application forms webpage for specific information for each license type. Please call 360-236-4661 with questions.

Can a physician office laboratory take specimens from the outside?

Yes, physician office laboratory (POL) can take specimens from outside providers but they need to notify our Medical Test Site Program staff members that they're no longer a physician office laboratory, but an independent laboratory. We'll then change the site type designation to an independent laboratory in the state and federal CLIA databases. The lab also needs to follow federal direct billing requirements.

What is a competency assessment?

 
Laboratories  must ensure the adequacy and competency of their staff who perform patient testing. A competency assessment is an evaluation of the ability of testing personnel to apply their skill, knowledge, and experience to perform laboratory duties correctly. Competency assessment must incorporate six specific procedures to comply with minimum regulatory requirements, and the assessments must be approved by the laboratory director or qualified designee. These requirements are outlined in the following document created by CMS (PDF), which details useful information on performing competency assessments for laboratory personnel.

Medical Test Site (MTS) and Clinical Laboratory Improvement Amendments (CLIA) Licensing

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, physician assistant, 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 within 30 days.

Complete the credential status change Form (PDF) to change information about your laboratory demographics (name, address, phone number, fax number), personnel (director, laboratory contact, etc.). Test menu additions, deletions, or volume updates should be submitted with a test menu change form (PDF). A change of ownership requires submission of 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 (PDF). 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 credential status change Form (PDF) 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.

Proficiency testing

When do I enroll?

If you're currently enrolled in proficiency testing, the time to renew for the following year is between October and December. New laboratories must enroll in proficiency testing to cover its regulated analytes (tests) at the time of application for the MTS license. Proof of enrollment must be submitted to the Medical Test Sites program (MTS) before an MTS license will be issued.

What program must I enroll in?

A laboratory must enroll for those programs that cover the testing that is performed. Generally, most programs are five-sample modules shipped in three test events during the year. Two sample programs are available and acceptable for non-regulated analytes only. Here is an example: A laboratory is performing rapid strep antigen with a non-waived kit, serum pregnancy and complete blood count (CBC) on an instrument. These are all regulated analytes. Therefore, a five-sample program must be selected for rapid strep antigen, serum pregnancy and a hematology module. (Note: Bacteriology, Mycology, Mycobacteriology: these subspecialties do not have "regulated analytes" per se. However, the laboratory must subscribe to a module that covers the testing performed.)

What strategy must I take to pass PT?

The PT provider lists the shipping dates for its samples. Mark these dates on a calendar you will see! If you will not be at the laboratory when the samples arrive, give special instructions to whomever will be there to put the samples in a specific place in the refrigerator and/or perform the testing for you. If the sample does not arrive around the shipping date, immediately call the PT company's 800 number.

When you test the PT samples, follow the directions exactly as provided by the company. If you encounter any issues with your samples, immediately call the 800 number for assistance. Otherwise fill out the answer sheet completely, listing the method, kit, reagent, etc. Your results will not be evaluated if your answer sheet is incomplete. Sign the Attestation Statement (Laboratory Director and Testing Personnel). Make a copy and put into the mail by the due date. If your mail system is unreliable, send it certified. Some of the PT companies will allow you to fax results.

When you receive your graded results, review the results with your laboratory director. If you receive a score of 60 percent or less (80 percent is passing for most analytes), you must investigate why you failed and document your plan of correction.

If you receive results that are not graded, call the 800 number for assistance. The PT provider will review the results with you. Under the Quality Assurance rule you must manually evaluate ungraded PT results.

What must I do if I add a new test?

You must notify our office immediately and, if this new test is a regulated analyte, you must cover the test in the next PT event. When you notify us, we'll remind you to enroll in PT and ask you for proof of enrollment.

What if I decide to stop testing an analyte?

You must notify our office immediately that you have stopped testing. If you have signed up for PT for this analyte, be sure to choose the code "test not performed" on the answer sheet.

Surveys/inspections

Do I need an inspection before I can start testing?

No, you may start billing for laboratory testing performed at your facility based on the "effective" date listed on your MTS license certificate.

Where can I get a copy of the MTS inspection checklists?

You may find MTS survey checklists and other helpful information on our Supplemental Materials webpage.

How do I file a complaint about a lab?

You may find complaint information on our website.