04/09/2020: Lab Update: FDA Clarifies CLIA-waived Status for Point-of-Care SARS-CoV-2 Tests under Emergency Use Authorizations. The U.S. Food and Drug Administration (FDA) recently clarified that, when it grants an Emergency Use Authorization (EUA) for a point-of-care test, that test is deemed to be CLIA-waived.
What regulations govern point of care testing?
The POCT regulatory environment In the United States, all clinical testing, no matter where it is performed, is regulated by the Clinical Laboratory Improvement Amendments of 1988 (CLIA). POCT typically refers to CLIA waived or nonwaived laboratory tests performed at remote locations by non-laboratory personnel.
Do waived tests require proficiency testing?
PT is not required for any test classified as waived. However, enrolling in a PT program and performing PT on your waived test(s) will provide you with an excellent indication of the accuracy and reliability of your waived test results thus improving the quality of testing you provide for your patients.
What is a waived test under CLIA?
As defined by CLIA, waived tests are categorized as “simple laboratory examinations and procedures that have an insignificant risk of an erroneous result.” The Food and Drug Administration (FDA) determines which tests meet these criteria when it reviews manufacturer’s applications for test system waiver.
What is waived point of care?
CLIA waiver is a regulatory term and point of care testing (POCT) refers to the location where the testing occurs. In other words, POCT means the testing isn’t happening in a central laboratory, it’s happening closer to the patient.
What are the requirements for non-waived testing?
The organization must maintain evidence that the testing personnel meet the education requirements established by their job descriptions. For each individual performing non-waived testing, the organization must maintain evidence of education that meets one of the personnel qualification routes defined in the CLIA at Subpart M*.
What is CLIA waiver nonwaived testing?
Please see the FDA’s webpage on CLIA Waivers Nonwaived testing is the term used to refer collectively to moderate and high complexity testing. Laboratories or sites that perform these tests need to have a CLIA certificate, be inspected, and must meet the CLIA quality standards described in 42 CFR Subparts H, J, K and M.
What is a waived test?
As defined by CLIA, waived tests are simple tests with a low risk for an incorrect result. They include: Tests that the manufacturer applies to the FDA for waived status by providing scientific data that verifies that the CLIA waiver criteria have been met
What is the difference between nonwaived testing and moderate testing?
Nonwaived testing is subject to inspection, and must meet the CLIA quality system standards, such as those for proficiency testing, quality control and assessment, and personnel requirements. The standards for moderate and high complexity testing differ only in the personnel requirements.
