CLIA Certificate of Waiver 101

New! Schools and Districts in New Mexico have the opportunity to be listed under the CLIA Certificate of Waiver of Regional Educational Cooperative #1. There are no fees and technical support is available. For more information, visit: http://www.nmrec1.org/clia-waivers/.

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.

If you already have a CLIA Waiver in place, you will need to contact the Department of Health Improvement at CLIA.DHI@state.nm.us and request COVID-19 testing be added to your existing waiver. Please include your current CLIA ID(s) and the following COVID-19 test names and manufacturers in your email to DHI.

NM Schools COVID-19 Program Anticipated Tests and Manufacturers

Analyte / Test	Test Name	Manufacturer
Rapid Antigen Testing	Abbott BinaxNOW COVID-19	Abbott
Rapid Antigen Testing	BD Veritor ™ Plus System	BD
Rapid Antigen Testing (for Detection of SARS-Co-V-2 & Flu A + B)	BD Veritor ™ System	BD
Rapid On-Site PCR	Accula Rapid PCR	Thermo Fisher Scientific
Rapid On-site PCR	Visby Medical RT-PCR	Visby Medical

Testing products used in this program may change in accordance with available supply and on-site needs.

Once your request is approved, please forward your confirmation email to info@nmschoolscovidtesting.com.

To apply your CLIA Certificate of Waiver to additional locations, please email CLIA.DHI@state.nm.us with your CLIA Certificate of Waiver ID and attach this linked spreadsheet, listing all your test sites. We recommend sending this email with a read receipt.

Please note that previous guidance indicated that you need to submit a full CLIA Certificate of Waiver application for every site that is performing testing. This guidance has changed to make the process easier for schools and school districts.

The application for a CLIA Certificate of Waiver can be found here. Although the form is from the CMS, it is submitted to the state licensing agency. The agency for New Mexico is the Division of Health Improvement (DHI).

For your convenience, we have begun a CLIA application for you. Please review it carefully to ensure that all of the details are correct.

NM Schools COVID-19 Program Anticipated Tests and Manufacturers

Analyte / Test	Test Name	Manufacturer
Rapid Antigen Testing	Abbott BinaxNOW COVID-19	Abbott
Rapid Antigen Testing	BD Veritor ™ Plus System	BD
Rapid Antigen Testing (for Detection of SARS-Co-V-2 & Flu A + B)	BD Veritor ™ System	BD
Rapid On-Site PCR	Accula Rapid PCR	Thermo Fisher Scientific
Rapid On-site PCR	Visby Medical RT-PCR	Visby Medical

Starter CLIA Certificate of Waiver Application - Revised 1/27/2022

Common CLIA Certificate of Waiver Errors

Tax ID is incorrect or missing
Missing name of Test and Manufacturer
Missing signature from the Director
Multiple schools listed on one application
Missing estimated number of tests
In Section VII, check if NO PPM tests are performed

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 info@nmschoolscovidtesting.com.
When your physical CLIA Certificate of Waiver arrives in the mail, please scan your copy and send it to info@nmschoolscovidtesting.com.

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CLIA Certificate of Waiver 101

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