CLIA-Antigen-Overview Own-CLIA Testing Program Overview

Own-CLIA Testing Program Overview

​​​​​Updates as o​​f July 27​​​​, 2023

  • Updated contact information and links

  • Updated information on software availability

  • Updated information around CLIA-waived reporting

Introduc​​tion

To improve the equitable distribution of testing resources to communities facing disproportionate effects of COVID-19, the State of California supplies professional antigen test to qualifying sites with their own CLIA Certificate of Waiver.* According to current federal and state laws, any facility performing professional COVID-19 tests on others needs to have a laboratory certification called a Clinical Laboratory Improvement Amendment (CLIA) Certificate of Waiver and a California clinical laboratory registration.  ​

*Note: Organizations that have their own CLIA may not use the State's CLIA.

Steps to Onboarding

  1. Identify testing need and submit application form​​​

  2. Ensure you are meeting California COVID-19 reporting requirements.

  3. Sign Acknowledgement of Responsibility and receive antigen tests

  4. Begin testing and reporting antigen test results

Primary Contact

Each testing locat​ion must have a designated primary contact.

Primary Contact Responsibilities:

  • Submit the organization's application to the​​​ Testing Program.

  • Serve as the primary Point of Contact (POC) for communications with the CDPH (ie. submitting reorder requests; informing CDPH of changes to POC, testing status, etc).

  • Sign the Acknowledgement and Acceptance of Responsibility.

  • Work with your CLIA lab director for organization-specific guidance on training and quality control (QC) procedures.

  • Maintain all associated training, quality control and testing documents and record per your CLIA lab director

  • Ensure you are meeting any required electronic reporting to public health (CalREDIE).

Overview of Free Software Available for CLIA-waived Testing

Method​​
Navica
 ​Simple Report
 Website

 Navica App for BinaxNOW
 Simple Report
Cost

Free

Free

Functionality

Participant registration and result upload capability.
Automated reporting to participant, site, and public health. Collection site dashboard.

Participant registration and result upload capability. Automated reporting to participant and public health.

 Timeline for adoption

Immediately available

Login access required, easy registration

User

Org/Individual

Org/Individual


Consent for Particip​ants

Organizations using their own CLIA waiver and Ordering Physician will need to manage consent for their participants. A sample consent is provided below.

NOTE: Because SARS-CoV2 is recognized as a communicable disease, which is required to be reported, California state law provides that minors 12 years and older can consent to diagnosis and treatment of COVID-19 and receive results through their own contact information or through their parent's contact information.
However, only minors 13-17 years of age may provide consent electronically or via paper informed consent forms.  Minors who are 12 years old are limited to providing consent via paper informed consent forms.

For minors under the age of 12, the parent or legal guardian must provide consent (electronically or via paper informed consent forms) and use parent or guardian email/phone to obtain results.

Sample Consent

Organization is pleased to offer site-based screening for COVID-19 using Abbott laboratories BinaxNOW COVID-19 Ag Card tests. These are rapid, point-of-care tests that deliver results in 15-30 minutes. This test is voluntary and will only be completed if this form is signed.

To collect the specimen, the participant will place a swab, similar to a cotton swab/Q-Tip, inside of the tip of the nose. A trained staff member will observe the specimen collection.

  • I authorize Organization to conduct specimen collection and testing for COVID-19 via nasal swab.

  • I acknowledge that a positive test result is an indication that I may have the COVID-19 virus. If I receive a positive test result, I acknowledge that I must self-isolate and continue to wear a face-covering to avoid infecting others.

  • I understand that Organization is not acting as my medical provider; that this testing does not replace treatment by my medical provider; and I assume complete and full responsibility to take appropriate action concerning my test result. I agree to seek medical advice, care, and treatment from my medical provider if I have questions or concerns, or if my condition worsens.

  • I understand that, as with any medical test, there is the potential for incorrect test results. I understand that a confirmatory test may be required depending on the result.

  • I have been informed about the test purpose, procedures, possible benefits and risks and I have received a copy of this informed consent. I have been given the opportunity to ask questions before I sign, and I may ask additional questions at any time.

  • I understand that my test results will be shared with clinical and other staff at the collection site and the local Public Health Department.

  • I have read, understand and agree to the above.

  • Signature of Participant

Disclaimer: Your decision to consent to the screening test is completely voluntary. Organization will take reasonable preca​​utions for the safety of the population. Neither the test administrator nor Organization nor any of its trustees, officers, employees, or organization sponsors are liable for any accident, injuries, or other damage that may occur to you arising out of or in any way connected to this consent or the administration, evaluation, or results of the BinaxNOW COVID-19 Ag Card rapid antigen test for the COVID-19 virus.

EUA Patient Fact Sheet for Participants

​​Each participant should be given the BinaxNow EUA Patient Fact Sheet, either electronically or as a paper copy.​


Originally Published on August 8​​, 2022​​​​​​​