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Introduc​​tion

To improve the equitable distribution of testing resources to communities facing disproportionate effects of COVID-19​, the State of California has established a comprehensive testing program that provides a CLIA-waiver and testing resources (e.g., tests, reporting platforms, and technical assistance) for point of care testing.

According to current federal and state laws, any facility performing professional antigen testing on individuals needs to have a laboratory​ certification called a Clinical Laboratory Improvement Amendment (CLIA) Certificate of Waiver and a California clinical laboratory registration. 

The CDPH has obtained these certifications on behalf of any participating organization if the organization agrees to our program requirements. 

Organization Requirement​​s to Participate and ​​use the CDPH CLIA Waiver

• All testing personnel must complete the required trainings.

•  All test results (ie. positive and negative), must be reported on Primary.Health.

• Perform and report quality control tests.

Quality control testing ensures the reliability and accuracy of test results.  As part of this program, your organization is a state-registered laboratory where quality control procedures are required.​

5 Steps to Onboarding the Community Rapid Testing Program

1. Submit Application Form. Sign MOU and receive antigen tests.

2. Complete training requirements.

3. See Next Steps to Join the Community RapidTesting Program (CLIA-waiver) for details.

4. Receive CDPH approval, begin testing, and report all antigen test results.

​Site Lead Responsibilities 

​Each testing location must have a designated Site Lead. The Site Lead is responsible for overseeing antigen testing at the testing location(s). Detailed and ongoing responsibilities for the Site Lead:

1.  Keep a record of trained personnel. Each trained tester must have completed the following prior to starting testing:
   

• Pass the training quiz with a score of 100%.
  

• Complete CDPH Information Privacy & Security Training.
  

• Complete a positive and negative control during the CDPH Hands-On Training session.
  

2. Complete the online Quality Control Log after performing quality control tests for each shipment of BinaxNOW test cards.​
   

3. Report any problems with test performance or product issues to CDPH using the quality control log.  Please report these issues as soon as possible, preferably same day.

4. Share updated information about your organization with the Community Rapid Testing Program (CLIA-Waived) via email at communityrapidtesting@cdph.ca.gov .
   

5. Ensure all people helping with testing are trained.

Contact us at communityrapidtesting@cdph.ca.gov  to train new testers or for updating shipping or testing addresses. Please read the CDPH Binax Binder (which is accessible on the Primary.Health site) for additional program detail. Follow-up testing for people who have symptoms and a negative antigen test.​​

Consent Information f​​or Children

 Consent Requirements by Age

Testing Considera​​tions

If a person has COVID-19 symptoms and an initial negative antigen test, they should test again 48 hours after the first test, for a total of at least two tests. Please send person home with 2 at-home self-tests and give the following instructions for follow-up testing at home.

1. Test yourself again in 24 hours.

2. If that test is negative but you still have symptoms, wait another 24-48 hours and take another test.

If your test is POSITVE at any time, reach out to your medical provider right away about medicines to fight COVID-19. Medications to treat COVID-19 are free, widely available, and effective for stopping COVID-19 illness from getting serious. Everyone 12 years and older who has symptoms and tests positive for COVID-19 should ask a doctor about treatment.

If you are uninsured or cannot reach a medical provider, get a FREE telehealth visit online or call 1-888-897-1244.
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