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.
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.
- CMS.gov CLIA Homepage
- CMS.gov State Agency Contacts
- CMS.gov How to Obtain a CLIA Certificate of Waiver