Reporting Requirements for Rapid Testing in Point-of-Care SettingsĪ CLIA-certified laboratory or testing site must report all positive SARS-CoV-2 diagnostic and screening test results to the person who was tested or that person’s healthcare provider. However, when these tests are either performed or the results are interpreted by someone other than the individual being tested or their parent or guardian, then the CLIA reporting requirements for waived tests must be followed.
OTC tests can be purchased and used in a point-of-care setting.
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The instructions for use provide specific information on how to perform the test, which specimens can be used, and the people who may be tested. The laboratory or testing site must use a test authorized for point-of-care use by the FDA and must follow the manufacturer’s instructions for each test. Tests that have been authorized for use in a point-of-care setting will have a W, for Waived, in the Authorized Settings column of the FDA table. 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). Tests That Can Be Used in Point-of-Care Settings See Over The Counter (OTC) Home Testing and CLIA Applicability 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. See How to Obtain a CLIA Certificate of Waiver 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 for the state where testing will be performed.Complete an application ( Form CMS-116 ), available on the CMS CLIA website 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, any one of which is appropriate for point-of-care testing. Regulatory Requirements for Rapid Testing in Point-of-Care Settings
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