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Opinion: Use of At-Home OTC COVID-19 Antigen Testing Kits (PIN 22-10-ASC)

Here is Clearpol’s opinion on PIN 22-10-ASC, which can be found on our website here alongside the AFL text:

CDSS provides guidance about the use of at-home Over The Counter (OTC) COVID-19 antigen testing kits. It also reminds licensees of the free CLIA waiver and free tests available through the CDPH Antigen Testing Program.

Self-administered FDA authorized OTC COVID-19 antigen test by visitors, staff and residents is acceptable for all CCLD testing requirements.

The self-administration and self-reading of the test must be observed by staff in real time – in person or via live streaming or with an authorized telehealth proctor. Any OTC COVID-19 antigen test that is both administered and read onsite at the facility by anyone other than the individual being tested (staff, visitor, resident) is strictly prohibited, unless it is administered by a medical professional or authorized staff at a facility that has received a CLIA Certificate of Waiver from CMS.

For residents, facilities must document how positive or negative test results will be tracked and methods for communication of facility results to the local health jurisdiction and CCL Regional office per PIN 20-23-ASC.

For staff who are exempt from vaccination requirement or who have not yet received their booster dose, facilities must maintain records of the staff COVID-19 testing results per PIN 21-53-ASC.

For visitors, records of vaccination verification and/or documentation of a negative COVID-19 test must be kept on file at the facility and made available, upon request, to CDSS and/or LHD, per PIN 22-07-ASC.

Licensees who conduct diagnostic screening testing at the facility should have a plan in place for tracking test results, conducting workplace contact tracing, and reporting to LHD per PIN 21-32.1 and 21-33-ASC.

Addendum A covers OTC COVID-19 Antigen Tests and CLIA Waiver Applicability. In general, a CLIA waiver is not required for an FDA authorized OTC COVID-19 antigen test, as long as the test is self-administered in strict compliance with the manufacturer’s instructions for use. If administered by someone other than the individual being tested or if the results are read and reported by someone other than the individual, then a CLIA waiver is required. If an antigen test is not being self-administered, it becomes a waived test. PIN 21-16-ASC describes the tests that have been waived by the FDA.

Facilities may still enroll in the CDPH BinaxNOW Antigen Testing Program for COVID-19, per PIN 21-30-ASC.


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