STEP 5B

Report results via IT platform to state’s public health reporting system (CalREDIE)

For organizations using the state’s CLIA waiver and ordering physician, the state’s contracted IT platform (Primary) will automatically report all results directly to CalREDIE in accord with California Code of Regulations Title 17, Section 2505 reporting requirements.

Organizations using their own CLIA ID and ordering physician may have IT vendors who also automatically report all results to CalREDIE (e.g., Navica). Otherwise, organizations can use the CalREDIE Manual Lab Reporting Module as their IT reporting platform and must report on a daily basis aggregate tests performed including: total tests, total positive results, total negative results, and total inconclusive or invalid results into the Daily Survey and report ONLY positive results on a daily basis into the CalREDIE Manual Lab Reporting Module to meet statutory and regulatory requirements. The Testing Task Force will provide access to the Daily Survey as needed. For more details, please view Appendix B .

Report significant deviations of test performance

Laboratories performing the test, including organizations using the state’s CLIA waiver, are required to report suspected occurrence of false positive (testing positive on antigen test and confirmatory PCR is negative) or false negative (symptomatic individual tests negative and the PCR comes back positive) results and significant deviations of test performance to the FDA and the manufacturer.  To assist with this reporting, testing sites that are using the State’s CLIA waiver and Ordering Physician should report significant product issues to antigenlabdirector-reporting@cdph.ca.gov to facilitate the laboratory’s reporting to the FDA and to the manufacturer. Emails summarizing any significant product issues/deviations should be sent no less frequently than once weekly during the testing week in which they occur. Sites can also independently report issues with tests to the FDA and to the manufacturer by emailing CDRH-EUA-Reporting@fda.hhs.gov and ts.scr@abbott.com, respectively.  Sites can also contact Abbott Technical Support at +1-800-257-9525.

Examples of product issues and deviations may include: test kits not performing correctly, controls not working, blue control line missing in untested test cards, not able to see control lines in the test card window, etc. Sites can record product issues in the Binax Antigen Test Product Issues log seen in Appendix H .

Send site records to CDPH Laboratory Director at AntigenLabDirector-Reporting@cdph.ca.gov (if using state’s CLIA waiver and Ordering Physician)

Send electronic copies of the site training documents, inventory quality control documentation, and any test deviation reports, adverse events, or product issues to the CDPH Laboratory Director. The Laboratory Director can be contacted at antigenlabdirector-reporting@cdph.ca.gov.

See Appendix F for the Training Log.

See Appendix H for the Binax Antigen Test Product Issues Log.