Patient and doctor

If your organization wants to start conducting simple or “waived” tests for patients in the United States, federal law requires that your site obtain a Clinical Laboratory Improvement Amendment (CLIA) Certificate of Waiver.  Having the appropriate certificate allows your organization to test patients on-site or at the point of care for mobile or off-site testing.  If you’re interested in using Thermo Fisher Scientific’s Accula rapid PCR solution, your organization must have a CLIA certificate in place.  If you don’t have one, here’s some help to get you started:

1. Know what you can test for

Understand what you can test for once you have a CLIA Certificate of Waiver by visiting the CDC’s website for current waived analytes. For COVID tests, check the list of test kit manufacturers with an FDA emergency use authorization. There must be a “W” in the column titled “Authorized Settings” for any test to be performed in a CLIA-waived laboratory.

2. Fill out the application

Fill out the CMS form #116 to apply for your certificate: Download it here!

3. Submit your application

The State Agency where your testing site is located will process your application. Check with your State Agency for any other state-specific requirements.

4. Repeat the process for other sites

Repeat the process for each testing location within your organization. (Visit CMS.gov to learn about certain exceptions that may limit the need to repeat the application process for additional locations.)

5. Pay the appropriate fees

Once you submit your application, you will receive information and instructions on submitting your certificate fees. Your certificate will not be sent to you until fees are paid.


What to expect next

Once your application is processed, you will receive a 10-digit certificate number. Test manufacturers, including Thermo Fisher Scientific, will require your certificate number when placing an order for testing supplies. You will also need to be prepared to pay your certification fees every two years to keep your certificate current.

Begin testing

Once you receive your certificate and all state requirements are met, you generally will be able to begin testing. Always remember to follow Thermo Fisher Scientific’s instructions for the tests that your team will be performing.

More information

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Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high, moderate, or waived complexity tests. The Accula SARS-CoV-2 Test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
This page is for informational purposes only. For the most up to date information, go to https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA.
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