STEP 3

Onboard to IT platform

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.

Identify site Binax Lead and assemble Binax binder

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

Identify staff to deliver reagent and read tests (recruit staff if necessary)

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.

Roles:

• 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

Set up facility 

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.

Manage crowd sizes
Certain measures must be used when testing large groups of people to avoid people congregating in the same area and to ensure appropriate physical distancing:

• Develop signage that directs participants where to check-in and line up
• Place markers on the ground to help participants maintain distance when waiting in line and at the different stations
• Consider placing educational materials where people are waiting to prepare them for the testing set up and teach them how to do self-swabbing (e.g., show continuous video).
• Consider using an appointment model or having assigned times for participants to avoid crowding
• Provide adequate space or private area for confidential reporting of results

Obtain supplies
Before testing begins, ensure that you have the following materials:

• Table space to lay the necessary number of cards flat during the 15-30 minutes when the tests will be running and read
• Paper towels or table covering like butcher paper to lay tests on
• Hand sanitizer to clean hands/gloves
• Trash cans with biohazard bags for used test kits and swabs
• Permanent markers like Sharpies (to mark the BinaxNOW COVID-19 Ag Card test cards)
• Large digital clock to write down time the tests were performed on the cards
• Optional Timers (to time the BinaxNOW COVID-19 Ag Card tests)
• Laminated reading materials: Interpretation Tree: Appendix C
• Appropriate technology devices (iPads/tablets/laptops with cameras) to use software to manage check-in and report results
• Paper consent forms in case of emergency (consent forms may be submitted electronically via the chosen software platform).
• Appropriate technology devices to run software (iPad/tablets/laptops with webcams)

¹ Physician assistants can perform collections of specimens for COVID-19 testing using nasal swabs as long as they meet the current waiver requirements of DCA Waiver 02-04 in the following circumstances: a) A physician assistant moves to a practice site or organized health care system to assist with the COVID-19 response, but does not have a practice agreement in place with any authorized physician of the site or system; or b) As a result of the COVID-19 response, no supervising physician with whom a physician assistant has an enforceable practice agreement is available to supervise the physician assistant. Please note that the waiver keeps in place the current law that all physician assistants must be supervised by licensed physicians, must be competent to perform the services they provide, and must be educated, trained and experienced to perform services. For more information please see Order Extending Three April 14, 2020, Orders Relating to Physician Assistant, Nurse Practitioner, and Nurse-Midwife Supervision By 60 Daysand Guidance on Physician Assistant Supervision Requirements Waiver Under DCA Waiver-02-04.

² Medical assistants can collect using nasal swabs, but front of the nose only. They may not collect using nasopharyngeal or oropharyngeal swabs

³ EMTs and paramedics are authorized by the Director of the California Emergency Medical Services Authority to collect nasopharyngeal swabs only for COVID-19 testing and only for the duration of the COVID-19 emergency. Additional information about the local option scope of practice allowing them to do this is available on the California Emergency Medical Services Authority webpage

⁴ Registered nurses can collect specimens using nasopharyngeal or oropharyngeal swabs

⁵ Nasopharyngeal or oropharyngeal swab collection is within the scope of practice for a licensed vocational nurse (LVN) and psychiatric technician (PT) as long as the LVN or PT: a) Receives specialized instruction in the proper procedure from a registered nurse or licensed physician; b) Demonstrates the requisite knowledge, skills and ability prior to performance of the procedure; and; c) Performs the procedure in accordance with a licensed physician’s order.

⁶ Respiratory care practitioners are authorized under their scope of practice to collect specimens using swabs, including nasopharyngeal and oropharyngeal swabs