The COVID-19 & Lab Testing Requirements Toolkit provides information on the federal certification process for practices interested in offering point-of-care testing.
The American Dental Association (ADA) has released a toolkit to help dental professionals interested in offering their patients rapid response, point-of-care COVID-19 testing within their practices.
The COVID-19 & Lab Testing Requirements Toolkit includes information for dental professionals on applying for the federal certification required to offer this type of testing.
While rapid point-of-care testing is not yet widely used, the toolkit is designed to help ensure practices that are interested in implementing testing in the future are compliant with all regulatory guidelines. These regulations are set by the Clinical Laboratory Improvement Amendments (CLIA) law, which applies to any dental practice that performs tests on human tissue, including saliva, plaque, blood, or hard or soft tissue. The law establishes quality standards for all laboratory testing to ensure accuracy, reliability, and timeliness of patient test results regardless of where the test was performed.
Tests for COVID-19 have received Emergency Use Authorization from the U.S. Food and Drug Administration. Dental professionals who register for a CLIA certificate of waiver from the Centers for Medicare & Medicaid Services may perform tests in their practices that have been classified as “waived” tests, which typically, according to the ADA, are simple procedures and laboratory examination that have a low risk of error.
The toolkit provides information on in-office testing and CLIA requirements, as well as additional laboratory testing requirements by state. Moreover, the toolkit includes information on applying for a federal certificate of waiver to offer patients point-of-care testing.