The California Department of Public Health (CDPH) has received questions about the policy of the federal Centers for Medicare & Medicaid Services to apply enforcement discretion that allows facilities to begin testing with Point of Care (POC) COVID testing devices (including, but not limited to, BinaxNOW antigen tests) as soon as they have submitted their application for a CLIA Certificate of Waiver (CoW). The CMS advises facilities that have submitted an application for a CLIA CoW to check with their State Agency before they begin testing, as states may have additional licensure requirements that must be met before testing can begin.
Laboratory Field Services (LFS) branch in CDPH is the CLIA State Agency for California. As such, LFS is enacting a temporary allowance for the duration of the California state of emergency to allow facilities to begin waived antigen testing for SARS-CoV-2 as soon as they have submitted a complete application for California clinical laboratory registration and received an acknowledgment of receipt from LFS. Facilities need not wait to receive LFS approval of their registration or their CLIA certificate of waiver. To qualify for this temporary allowance:
- The facility must submit its application for California registration via the
New online Application on the LFS webpage.
- LFS strongly encourages facilities to apply online. A facility submitting a paper application must wait to receive approval of California registration before beginning to test.
- The facility may only perform waived antigen testing for SARS-CoV-2 using a test authorized for emergency use (EUA) by the FDA for POC use, and this allowance applies only for the duration of the California state of emergency.
- Once the facility receives its California registration and CLIA certificate of waiver, it may perform any other waived testing for which it is approved.
- If the facility’s application is not approved, LFS will notify the facility of the reason.
- The facility must meet the registration requirements or submit missing information within 10 calendar days. If it does not respond within 10 calendar days, the facility must cease all SARS-CoV-2 testing until it meets the requirements and receives approval of its California registration.
- The facility must arrange with CalREDIE to report results pursuant to the California Code of Regulations, title 17, section 2505.
Further restrictions and requirements may be formalized by CDPH.
Original signed by Paul B. Kimsey, Ph.D.
Paul B. Kimsey, Ph.D.
California State Public Health Laboratory Director
Original signed by Robert J. Thomas
Robert J. Thomas
Branch Chief, Laboratory Field Services
OFFICE OF THE STATE PUBLIC HEALTH LABORATORY DIRECTOR