Transcription of Antigen Testing Playbook
1 Information contained in this document is preliminary | Working draft as of 4/26/2021. 1 CDPH Testing Task Force Antigen Testing Playbook DRAFT 4/26/2021 Version All healthcare guidance contained in this manual is based on CDPH / CDC guidelines Information contained in this document is preliminary | Working draft as of 4/26/2021. 2 Table of Contents Introduction .. 3 Roles and responsibilities for Antigen Testing .. 3 5 steps to conduct Antigen Testing .. 4 1. Identify Testing need and submit application form .. 6 2. Sign MOU or Acknowledgment and receive Antigen tests .. 8 3. Onboard to IT platform and prepare logistics for Testing .. 9 4. Train staff .. 13 5. Begin Testing and deliver Antigen test results .. 155 Appendix.
2 23 Information contained in this document is preliminary | Working draft as of 4/26/2021. 3 Introduction In an effort 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 Antigen and PCR Testing resources ( , test kits, reporting platforms, and technical assistance). This document outlines how organizations can utilize Antigen tests (available through the state) and when needed, conduct confirmatory PCR tests (also available through the state). Please note, all results must be reported in accordance with state and federal requirements, and entities must have the ability to conduct serial Testing on a population ( , Testing a person at least 2x per week for multiple weeks) OR require rapid tests for entry into congregate setting or large gathering.
3 Given various nuances, a set of population-specific Antigen Testing playbooks are also available: Schools Playbook : please contact Department of Social Services (DSS) Playbook : please contact Roles and responsibilities for Antigen Testing State responsibilities Approve organizations, provide support and instructions for conducting Testing Provide an opportunity for organizations to do Antigen Testing under the direction and oversight of a state-designated Ordering Physician and Laboratory Director Provide options for IT platform solutions for Antigen and PCR test registration, delivering participant results, and reporting to the state, local, and federal government Supply Antigen tests to organizations who have undergone the training Supply PCR test kits for confirmatory Testing for facilities interested in using the Valencia Branch Laboratory for confirmatory PCR tests Conduct PCR test processing and provide results within 24-48 hours through the Valencia Branch Laboratory Information contained in this document is preliminary | Working draft as of 4/26/2021.
4 4 Organization responsibilities Provide required information to CDPH for registration, attest to serial Testing of population, and adhere to all program requirements as outlined in the MOU Provide staff and manage on-site logistics ( , obtain personal protective equipment, provide physical space, supervise sample collection, order test kits, onboard onto IT platform) Ensure that all staff supervising and performing the test are fully trained Report results to the participant with EUA Patient Fact Sheet, to the ordering physician, and to local public health jurisdiction via IT platform options Comply with governing CDPH policies and procedures regarding data storage, confidentiality, and privacy protection 5 steps to conduct Antigen Testing The state has partnered with Abbott to offer the BinaxNOW COVID-19 Ag Card, enabling Local Health Jurisdictions (LHJs) and local organizations to provide COVID-19 Antigen Testing efficiently and effectively to their communities.
5 As an organization, you can partner with the State to offer COVID-19 Antigen tests by following a 5-step process: 1. Identify Testing need and submit application form Identify the Testing demand in your community or organization Choose an IT platform for reporting (if using the state s Ordering Physician and Laboratory Director ( , CLIA waiver), the designated IT platform is Primary) Submit application form Develop plans for confirmatory PCR Testing 2. Sign MOU or Acknowledgment and receive Antigen tests Sign MOU or Acknowledgement Receive Antigen tests 3. Onboard to IT platform and prepare logistics for Testing Onboard to IT platform Identify site Binax Lead and assemble Binax binder Information contained in this document is preliminary | Working draft as of 4/26/2021.
6 5 Identify staff to deliver reagent and read tests (recruit staff if needed) Set up facility 4. Train staff Ensure staff complete required self-serve trainings Complete virtual hands-on training and competency quiz (requires Antigen tests on hand) Complete initial quality control and product inventory log Onboard to Valencia Branch Laboratory for PCR Testing (If using the state s CLIA waiver or partnering with VBL for confirmatory PCR Testing ) 5. Begin Testing and deliver Antigen test results Register and obtain consent from participants Check-in participants on Testing day Supervise nasal swab sample collection Perform the tests Read tests, communicate results, and identify next steps Distribute EUA Patient Fact Sheets (can be done via IT platform) Conduct confirmatory PCR test (if applicable) Dispose of cards appropriately Report results via IT platform to state s public health reporting system (CalREDIE) Report significant deviations of test performance (examples provided in section 5) Send site records to CDPH Laboratory Director at (if using the state s CLIA waiver and Ordering Provider)
7 Information contained in this document is preliminary | Working draft as of 4/26/2021. 6 Detailed instructions to the 5 steps to conduct Testing 1. Identify Testing need and submit application form Identify the Testing demand in your organization or community Choose an IT platform for reporting (if using the State s Ordering Physician and Laboratory Director ( , CLIA waiver), the designated IT platform is Primary) Submit application form Develop plans for confirmatory PCR Testing Identify the Testing demand in your community or organization Before proceeding with offering Testing , organizations need to determine their Testing demand and make decisions on the following: Populations to be tested, , all employees in an organization or in a given building.
8 Note: for the best results in preventing new infections or outbreaks, the Testing Task Force recommends that all employees in a given facility be tested regardless of job title or position Testing can be performed in people with COVID-19 symptoms or people without symptoms. When Testing people without COVID-19 symptoms, the recommend Testing frequency is at least 2 times per week Pre-entry Testing : Testing can also be performed if rapid results are needed for entry into a congregate setting ( , shelter) or an event ( , live performance, sporting event) Determine location where Testing will be performed in the facility Choose an IT platform for reporting Organizations using the state s CLIA Certificate of Waiver (under its Laboratory Director) and Ordering Physician will use the state s contracted IT platform, Primary, to help with participant registration, participant consent, test result management, and mandated electronic reporting to public health (CalREDIE).
9 Primary will provide training related to use of its software. Information contained in this document is preliminary | Working draft as of 4/26/2021. 7 For organizations not using the state s CLIA Certificate of Waiver and Ordering Physician, the state recommends using an IT platform of the organization s choice to support registration and reporting. Contact information for potential providers are located in Appendix B. Depending on the vendor, choosing an IT platform may require contracting with the vendor. The preferred IT platform must be specified in the application form. Submit application form After identifying the Testing demand, if your organization is interested in partnering with the state, please submit the Antigen Testing application form.
10 Note: entities without CLIA waivers who have existing stocks of BinaxNOW COVID-19 Ag Card tests can now onboard to the Testing Task Force s Antigen Testing offering by submitting the application form. These entities can use the state s CLIA waiver, ordering physician, and IT platform, and their existing Antigen test supplies to test worker cohorts. At this time, the state s CLIA waiver may only be used for the BinaxNOW COVID-19 Ag Card tests, not with any other COVID-19 tests, including other Antigen tests. Once submitted, a representative will reach out to you within 3-5 business days. Develop plans for confirmatory PCR Testing Confirmatory PCR Testing is required when an individual receives a positive Antigen test result OR is symptomatic ( , fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat) and receives a negative Antigen test result.
