Laboratory Quality Assurance (LQA)

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License Types, Requirements, and Application Forms

MTS/CLIA Application Decision Tree

The Washington Medical Test Site (MTS) licensure program is exempt from the Clinical Laboratory Improvement Amendments of 1988 (CLIA). You do not need to apply to CMS for a CLIA number. Your MTS license will contain both your MTS license number and your CLIA number.

The type of testing performed determines the MTS/CLIA license category. What type of tests are you performing or going to perform? Select from the following four options:

1. Waived (Certificate of Waiver) » Only tests on the Food and Drug Administration (FDA) approved waived test list can be performed under this category of license.

• Complete the Certificate of Waiver MTS/CLIA license application.

• If your test kit does not appear on the FDA approved waived test list, you do NOT qualify for this license type. See the Categorized or Accredited license information below.

• Contact the LQA office at 253.395.6746 if you need help determining what classification of testing you perform.

Certificate of Waiver MTS/CLIA License Application Form and Instructions

2. PPMP » Provider Performed Microscopic Procedure

Under this category of license, the facility can perform all CLIA waived tests and the nine approved microscopic procedures, if performed only by the following people:

• MD (Medical Doctor)

• DO (Doctor of Osteopathy)

• DPM (Doctor of Podiatric Medicine)

• ARNP (Advanced Registered Nurse Practitioner)

• Nurse Midwife

• PA (Physician Assistant)

• Naturopath

• Dentist

• Complete the PPMP MTS/CLIA license application.

• 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.

• Contact the LQA office at 253.395.6746 if you need help determining what classification of testing you perform. 

PPMP MTS/CLIA License Application Form and Instructions

If you perform tests other than waived or PPMP tests, you qualify for the following MTS/CLIA license types:

 3. Categorized

• The FDA classifies tests as either moderate or high complexity.

• Specific personnel requirements apply to the Categorized MTS/CLIA license based upon the type of testing performed.

• Complete the Categorized MTS/CLIA license application.

• Inspection will be performed DOH Laboratory Quality Assurance surveyors.

• Contact the LQA office at 253.395.6746 if you need help determining what classification of testing you perform. 

Categorized MTS/CLIA License Application Form and Instruction

4. Accredited

• The FDA classifies tests as either moderate or high complexity.

• Specific personnel requirements apply to the Accredited MTS/CLIA license based upon the type of testing performed.

• Must apply to one of the approved private Accreditation Organizations to monitor and inspect your facility.

• 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

• Complete the Accredited MTS/CLIA license application.

• Inspection will be performed by accreditation organization surveyors.

• Contact the LQA office at 253.395.6746 if you need help determining what classification of testing you perform.

NOTE:  If you do NOT want to be accredited and inspected by a private Accreditation Organization, follow the Categorized MTS/CLIA license application instructions above. 

Accredited MTS/CLIA License Application Form and Instructions 

Good Laboratory Practices:

A self» study PowerPoint presentation on good laboratory practices can be activated by clicking on the following text: Good Laboratory Practices with Waived Test Systems. If you need the Microsoft PowerPoint viewer to open this document, click here. You can also download the 134 KB file by right clicking the link and selecting "Save Target As..."

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Washington State Department of Health
Facility Services Licensing
P.O. Box 47852
Olympia, WA 98504-7852
Phone: (360) 236-2905
Fax: (360) 236-2901 

Last Update : 04/10/2012 01:27 PM
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