Safer Together is certified as a clinical laboratory, with a CLIA Certificate of Waiver that lets us offer any medical testing that is approved as CLIA-waived under the supervision of a prescribing doctor. The FDA has issued Emergency Use Authorization and CLIA-waived status for all COVID-19 tests that Safer Together administers.
Our prescribing doctor is Yvette Wild, MD, a pediatric gastroenterologist at UCSF.
The Clinical Laboratory Improvement Amendments (CLIA) program ensures quality laboratory testing in the United States. The Centers for Medicare & Medicaid Services (CMS) regulate all laboratory testing (except research) performed on humans in the U.S. through CLIA.
There are four types of CLIA Certifications, with a CLIA Certificate of Waiver being issued to laboratories that only perform waived tests. 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.
All COVID-19 tests that Safer Together administers have an FDA Emergency Use Authorization that categorizes them as waived tests.