STEP 3Onboard to IT platform and prepare logistics for testing
Select your testing type?
How to apply
How to get ready for testing
2 – Sign MOU or Acknowledgement and receive antigen tests
3 – Onboard to IT platform and prepare logistics for testing
Identify site Binax Lead and assemble Binax binder
Identify staff to deliver reagent and read tests (recruit staff if necessary)
Ensure staff complete required trainings
Complete virtual hands-on training and competency quiz
Complete initial quality control and product inventory log
How to conduct tests
5A – Begin testing and deliver antigen test results
Register and obtain consent from participants
Supervise nasal swab sample collection
Read tests, communicate results, and identify next steps
Distribute EUA Patient Fact Sheet (can be done via IT platform)
Conduct confirmatory PCR test (if applicable)
What to do after testing
For organizations using the state’s CLIA Certificate of Waiver and Ordering Physician, the state’s contracted IT platform, Primary, will send an email to complete the onboarding process. Primary helps manage testing day operations including participant registration, consent, and results, as well as reporting to public health (via CalREDIE).
The organization lead will receive information from Primary after being approved as a testing partner and receiving an approval email from the Testing Task Force. The organization lead will need to provide details about staff members for each site to Primary to onboard individually to the Primary platform. Each staff member will also be required to complete self-serve trainings on the Primary platform including on conducting antigen tests and using the Primary platform.
Organizations not using the state’s CLIA waiver and Ordering Physician should follow-up with their chosen IT platform vendor for steps for onboarding to the platform and training staff on how to register participants and report results to participants. Contact information for potential providers are in Appendix B.
Paper forms can be printed as a back-up in case of internet problems. If paper forms are used, all information collected must be entered in the online platform once internet is available. As participant data are collected on these paper forms, the testing site is responsible for securely shredding these documents. This is necessary because the data are considered personal health information (PHI), which is protected by HIPAA.
Organizations should identify one or two persons to be the “Binax Lead” who will be responsible for ensuring that all procedures are being properly followed and all personnel are properly trained. The Binax Lead will maintain a binder with the printed training material, training records, the quality control records, product inserts, and other material. The Binax Lead will also be responsible for training additional personnel as needed.
The Binax binder should include the following:
- Copy of the prescribing order
- Copy of the CA State Clinical Laboratory Registration with CLIA ID
- Name of Binax Lead(s) for site
- Copy of signed MOU (i.e., signed both by site and state)
- Copy of the Emergency Use Authorization (EUA)
- Current Manufacturer’s Instructions for Use (IFU)
- Current EUA Fact Sheets
- Product Insert information
- BinaxNOW COVID-19 Ag Card safety data sheet
- Site roles and responsibilities list including names of testing personnel at site
- Antigen testing playbook
- Training documentation and logs:Appendix F
- Binax Antigen Test Product issues log:Appendix H
- Additional manufacturer’s information including test kit expiration date extensions
- Shipment records that accompany delivered tests
Organizations must have trained staff on site to oversee all aspects of testing. Testing involves several roles. Number of staff required will vary based on size and organization, and one person can perform multiple roles if necessary.
- Check-in: Performs check-in and associates the BinaxNOW COVID-19 Ag Card individual test card with the staff member or student
- Swab Supervisor: Monitors self-collection
- Tester: Performs the BinaxNOW COVID-19 Ag Card test
- Reader: Tracks the time of the test and reads the results
- Data Entry: Enters the data into the software platform
Identify appropriate facility Designate a secure place to store the BinaxNOW tests where temperature does not fall below 36 degrees Fahrenheit or above 86 degrees Fahrenheit. BinaxNOW tests have a shelf life between 6 to 9 months. Expiration date can be found on the outside of the boxes near the lot number. Ensure that your site has a designated space in which you can register participants and conduct testing. Outdoor locations are ideal to reduce COVID-19 transmission. If you choose an outdoor location, have contingency plans for inclement weather such as wind/rain, have supplies to cover electronics and paperwork, and an alternative indoor location such as a gymnasium. If an outdoor location is not feasible, then indoor spaces should offer space for proper social distancing measures. Whatever the testing location, you will need flat areas to lay the cards on when performing the test, such as tables. Procure necessary Personal Protective Equipment (PPE) It is your responsibility as an organization to ensure all staff/volunteers have appropriate PPE. PPE needs may vary based on the sample collection situation (observing self-collection versus collection by trained provider). Most individuals can self-collect.
|Situation||Personnel requirement||PPE requirement|
|Observation of self-collection anterior nares swabs||Personnel observing individuals performing self-collection should be trained on proper technique.||All staff should follow|