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Food and Drug Administration (FDA) website for a list of the SARS-CoV-2 point-of-care and rapid tests that have received Emergency Use Authorization (EUA) external icon. Tests That Can Be Used in Point-of-Care Settings

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See Over The Counter (OTC) Home Testing and CLIA Applicability pdf icon external icon for more information from CMS. In these circumstances, the tests are not considered self-tests and the point-of-care testing site that performs the testing or interprets the test results needs a CLIA certificate and must report results as described below. A temporary COVID-19 testing site can only perform CLIA-waived or FDA-authorized point-of-care tests for SARS-CoV-2 and must be under the direction of the existing laboratory or testing site director.ĬMS has provided specific guidance for the use of FDA authorized OTC self-tests when these tests are either performed or the results are interpreted by someone other than the individual being tested or their parent or guardian. The State Agency should be notified of any changes to the laboratory or testing site ownership, name, address, or director within 30 days.ĭuring the COVID-19 public health emergency, CMS allows a laboratory or testing site to use its existing Certificate of Waiver to operate a temporary COVID-19 testing site in an off-site location, such as a nursing home or drive-through location. The point-of-care testing site must keep its certificate information current.

A non-certified point-of-care testing site will be treated as operating under a Certificate of Waiver while their application is being processed. Laboratories or point-of-care testing sites that have applied for a CLIA Certificate of Waiver to perform SARS-CoV-2 point-of-care testing can begin testing and reporting SARS-CoV-2 results as soon as they have submitted their application to the State Agency, as long as they meet any additional state licensure requirements that apply.

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See How to Obtain a CLIA Certificate of Waiver pdf icon external icon for more information.

Pay the CLIA Certificate of Waiver fee, following instructions provided by the State Agency.

Send the completed application to the address of the local State Agency external icon for the state where testing will be performed.

Complete an application ( Form CMS-116 pdf icon external icon ), available on the CMS CLIA website external icon or from a local State Agency.

A CLIA Certificate of Waiver is appropriate if SARS-CoV-2 point-of-care testing is the only testing being performed. A CLIA certificate is required to perform point-of-care testing. There are four different types of CLIA certificates pdf icon external icon, any one of which is appropriate for point-of-care testing. Regulatory Requirements for Rapid Testing in Point-of-Care Settings

Temporary locations, such as drive-through sites managed by local organizations.

Long-term care facilities and nursing homes.

These tests can be used to diagnose current or detect past SARS-CoV-2 infections in various point-of-care settings, including but not limited to: Rapid tests used in point-of-care settings can be NAAT, antigen, or antibody tests. Point-of-care testing uses rapid diagnostic tests performed or interpreted by someone other than the individual being tested or their parent or guardian and can be performed in a variety of settings.

Learn More About Performing Rapid Tests in Point-of-Care Settings.

Specimen Collection & Handling of Rapid Tests in Point-of-Care Settings.

Reporting Requirements for Rapid Testing in Point-Of-Care Settings.

Regulatory Requirements for Rapid Testing in Point-of-Care Settings.