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 § 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.