CLIA Certificate of Waiver 101
All schools conducting Point of Care (PoC) tests, including COVID-19 tests, need to have a valid Clinical Laboratory Improvement Amendment (CLIA) Certificate of Waiver.
Point-of-care tests are diagnostic tests performed at or near the place where a specimen is collected. A CLIA Certificate of Waiver allows you to carry out these low complexity PoC tests outside of the traditional clinical laboratory setting but with some professional oversight. Only certain tests qualify as CLIA-Waived tests. A full list can be found at this link. As you’re planning your COVID-19 testing program, we also encourage you to consider including other CLIA-waived tests on your application in order to support your school health program as a whole.
Your CLIA Certificate of Waiver must include every site for which testing is performed and every test type.
If you are participating in training with PMG (Program Option B) or administering rapid antigen tests (Program Option C), you will need to share a copy or proof of a CLIA Certificate of Waiver to continue with the program. Read below for guidance on what to do if you have or need a CLIA Certificate of Waiver.
CLIA Waivers are required for each location where PoC waived test are being conducted. If you plan to process test kits on-site with your staff you will need an active CLIA Certificate of Waiver.
Lab-based testing where samples are collected on-site and mailed to a lab for processing does not require a CLIA Certificate of Waiver.
After you have filled out your application:
- Submit your completed application to the New Mexico Division of Health Improvement (DHI) at CLIA.DHI@state.nm.us
- You will receive a confirmation email when your application is approved by DHI. We recommend paying electronically with the link provided. If you are unable to pay electronically, you will need to wait approximately two weeks to receive an invoice. To request a new invoice or certificate please email June Rose at June.Rose2@cms.hhs.gov.
- After payment, your CLIA Certificate of Waiver is active. Forward your receipt to email@example.com.
- When your physical CLIA Certificate of Waiver arrives in the mail, please scan your copy and send it to firstname.lastname@example.org.
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