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Certificate of Waiver Medical Test Site (MTS) Application Packet

Certificate of Waiver Medical Test Site (MTS) Application Packet 2026

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The document is an application packet for obtaining a Certificate of Waiver for Medical Test Sites (MTS) in Washington State. It includes an index, application instructions checklist, and the application form itself. The packet outlines the exemption from CLIA regulations for licensed laboratories, details on submitting the application and fee, and specific requirements for demographic information, facility specifics, key individuals, and waived tests. It emphasizes the importance of accurate information submission and provides contact details for assistance.

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Click ‘Get Form’ to open the Certificate of Waiver Medical Test Site Application Packet in our editor.
Begin with the Index Page (505-038) to familiarize yourself with the contents and structure of the application. This page outlines all necessary documents.
Refer to the Application Instructions Checklist (505-039). Ensure you have all required documentation ready, including your UBI and FEIN numbers.
Fill out Section 1: Demographic Information. Enter your business details clearly, including legal owner/operator entity name, mailing address, and contact information.
Proceed to Section 2: Facility Specific Information. Indicate your site type and hours of operation for laboratory testing.
Complete Section 3: Key Individuals by providing names and contact details for the lab director and lab contact person.
In Section 4, list any waived tests you plan to perform. Be specific about test manufacturers and systems used.
Finally, review Section 5 for any additional licensure information needed. Sign and date the application before submission.

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Versions	Form popularity	Fillable & printable
2020	4.8 Satisfied (158 Votes)
2019	4 Satisfied (40 Votes)
2015	4.4 Satisfied (26 Votes)

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How long does it take to get a CLIA waiver?

The fee for a Certificate of waiver is $150. CLIA Certificate of Waiver (COW) Requirements: To qualify for a certificate of waiver, your camp must only perform tests that have received the CLIA waived status. If you meet this requirement, simply fill out the application form CMS-116 at the CMS website (attached below).

Does CLIA waived mean FDA approved?

Waived tests include test systems cleared by the FDA for home use and those approved for waiver under the CLIA criteria. While CLIA requires waived tests to be simple and low-risk, they are not completely error-proof.

What does a CLIA waiver allow?

What is waived testing? By the CLIA law, waived tests are those tests that are determined by CDC or FDA to be so simple that there is little risk of error. Some testing methods for glucose and cholesterol are waived along with pregnancy tests, fecal occult blood tests, some tests, etc.

Is there an expiration date on CLIA waivers?

How long are they effective? All types of certificates are effective for two years and renewable. CLIA waived certificate is $150 (every two years), CLIA PPM certificate is $200 (every two years), and CLIA compliance or accredited (every two years and fee is based on number of tests and specialties).

How much does the CLIA waiver cost?

To get a CLIA certificate for your laboratory, follow these steps: Step 1: Complete the CLIA application (Form CMS-116) Step 2: Send your completed CLIA application to your State Agency. Step 3: Receive your fee coupon, which includes your CLIA identification number, to. Step 4: Pay your CLIA certification fee.

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