Journal of Urgent Care Medicine

Avoid CLIA-Waived Testing Violations in Urgent Care

Urgent message: Most of the laboratory testing that occurs in urgent care consists of simple, on-site tests that are “waived” from federal CLIA regulations—but urgent care centers must still comply with standards affecting their CLIA waiver. All facilities in the United States that perform laboratory testing on human specimens for health assessment or the diagnosis, prevention, or treatment of disease are regulated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). CLIA requires laboratories to …

UCA Advocates for Urgent Care in Comments on FDA CLIA Draft Guidance

The Urgent Care Association is one of numerous organizations that have filed comments regarding a draft Food and Drug Administration Guidance on CLIA-waived tests. UCA, and others, charge that the spirit of Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices runs counter to the intent expressed by Congress in passing the amendment. For one thing, they maintain, the FDA must remove proposed discussion …

Henry Schein, Cepheid Bring Molecular Diagnostics to the Urgent Care Arena

Cepheid has inked a deal with Henry Schein Medical to distribute its GeneXpert System and menu of Xpert tests for healthcare-associated infections, critical infectious disease, and sexual health in more than 10,000 laboratory customers in the United States—urgent care centers among them. Previously, the GeneXpert System could be found mainly in hospital laboratories. Subject to FDA review of the GeneXpert Omni System and associated tests, Henry Schein will also distribute Cepheid’s CLIA-waived products for the …