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Laboratory Field Services

Guidelines for Skilled Nursing Facilities and Other Facilities Performing Waived Antigen Testing

Facilities performing CLIA-waived antigen testing for SARS-CoV-2, the virus that causes COVID-19 disease, must meet federal and state clinical laboratory requirements and state clinical laboratory personnel requirements, and comply with state and local reporting requirements.

Clinical Laboratory Requirements

Facilities performing only waived tests for COVID-19 must have a federal CLIA Certificate of Waiver and a California Clinical Laboratory Registration. For information about obtaining certification and registration, please visit the LFS Facility Registration webpage.

Laboratories applying for certification and registration for the purposes of COVID-19 testing should send the application to LFSCOVID@cdph.ca.gov for expedited processing. If you are submitting an application for COVID-19 testing only, we will do our best to expedite the process and notify you of the decision within 10 days of receipt of a complete application. If LFS approves the application, the licensed laboratory can begin testing as soon as you receive the pdf certificate is by email.

Personnel Requirements

The laboratory must have a laboratory director who meets the requirements of Business and Professions Code section 1209(a). The laboratory director of a registered laboratory is responsible for documenting the educational background, training, and experience qualifications of the personnel directing and supervising the laboratory and performing the laboratory test procedures and examinations.

The laboratory director may choose to delegate responsibilities to a waived laboratory supervisor, who must meet the requirements of Title 17 of the California Code of Regulations section 1036.3 and must be accessible to the laboratory testing personnel to provide onsite, telephone or electronic consultation.

Testing personnel must meet the requirements of BPC section 1206.5(a). If they do not meet California licensure or certification requirements, Executive Order N-25-20 suspends those requirements for personnel who meet the CLIA requirements in 42 CFR 493.1489.

Personnel performing point-of-care testing in facilities such as long-term care facilities, hospitals, physician offices, urgent care, outreach clinics, and temporary patient care settings must be trained to perform the COVID-19 testing, but these sites have no testing personnel licensure requirements.

Reporting Requirements

All laboratories testing for SARS-CoV-2 must report test results to the health officer of the local health jurisdiction where the patient resides.

California law requires laboratories to report all positive and non-positive (negative, indeterminate, and specimen unsatisfactory) test results from molecular, antigen, and antibody/serology tests for SARS-CoV-2. Recent changes to California regulations require laboratories to report through the CalREDIE Electronic Laboratory Reporting system (ELR) within eight hours from the time that the laboratory notifies the health care provider or other person authorized to receive the report. See 17 CCR section 2505 (PDF) for laboratory reporting requirements.

The recent changes to the regulations also require laboratories to report data on patients’ race and ethnicity for all COVID-19 test results. Please ensure your requisition forms include this information, and work with the healthcare providers you serve to ensure that demographic information is collected during patient intake so that you can include it when you report results through the CalREDIE system.

Local health jurisdictions may have additional reporting requirements. Please check with the health officer for your laboratory’s jurisdiction.
Ordering health care providers are also required by law to report results of cases or suspected cases of COVID-19 to the local health officer for the jurisdiction where the patient resides and should contact the local health officer for specific requirements. Health care providers are required to provide information about patients’ race, ethnicity, current gender identity, sex assigned at birth, and sexual orientation. See 17 CCR section 2500 (PDF) for provider reporting requirements.

Further information about reporting requirements and enrollment in CalREDIE is available on the CalREDIE webpage.

Resources

More information about antigen testing in skilled nursing facilities:

 

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