| Covid-19 | Dec 22, 2020

CMS Issues Updated CLIA Guidance during the COVID-19 PHE

CMS issued an updated frequently asked questions (FAQ) on Clinical Laboratory Improvement Amendments (CLIA) guidance for the COVID-19 public health emergency. The December 17 updates indicate:

– Laboratories may develop their own quality control plans for “non-waived” COVID-19 test systems with an emergency use authorization in instances when the manufacturers’ quality control instructions are less stringent than the CLIA quality control requirements at 42 CFR ยง 493.1256. Laboratories that opt to implement an individualized quality control plan are instructed to refer to the State Operations Manual, Appendix C.

– FDA authorized the first prescription home use COVID test, the Lucira COVID-19 All-In-One Test Kit, in November. This test is also authorized for Point of Care (POC) use in patient care settings operating under a CLIA Certificate.