Please Read Information Below Carefully!
The Missouri Department of Health and Senior Services (DHSS) is pleased to announce that effective Thursday, February 10, 2022 at 8:00 a.m., we are reopening our antigen testing program! As you are aware, due to a nation-wide shortage of antigen tests and issues with receipt of tests from our distributor, it was necessary for us to suspend that program indefinitely in early January. For awareness, although Friday, February 11, 2022 is a state holiday, we will be accepting requests for tests, but no tests will be shipped on that day.
We have subsequently identified two distributors with adequate supply of ACON Flow Flex rapid antigen tests to allow us to reopen our antigen testing program. Information about ACON Flow Flex can be found here.
The transition to this different rapid antigen test requires the establishment of a new state-wide CLIA (although organizations with their own CLIA can continue to use their own) and thus verification of locations of testing and validation of training of all test administrators. Thus, it is not possible to simply transition existing BinaxNOW users to ordering for ACON Flow Flex – all existing users will need to re-apply to receive ACON Flow Flex, take the required training and provide verification of that training, resubmit a test plan inclusive of the infectious waste disposal plan, and provide the locations of testing in order to be approved to receive tests. Note: For organizations using their own CLIA, please be sure to add ACON Flow Flex to your CLIA waiver by contacting the state CLIA program (see additional information below).
New standing physician’s orders specific to ACON Flow Flex have been established for all tests users previously under a DHSS standing physician’s order. These new orders are available at: https://health.mo.gov/living/healthcondiseases/communicable/novel-coronavirus/testing-resources.php.
The DHSS Rapid Antigen Test Kit Application and Resource web page includes the initial application and a subject index to answer questions we received during the previous distribution of antigen tests. The page also provides information about where to direct specific questions that test users may encounter. If a test user is unsure of where to direct a question, please contact antigentesting@health.mo.gov.
The DHSS Rapid Antigen Test Kit Application and Resource Page for ACON Flow Flex will be open effective 8:00 a.m. on Thursday, February 10, 2022 at: https://health.mo.gov/living/healthcondiseases/communicable/novel-coronavirus/testing-resources.php.
Thank you for your continued work to fight COVID!
Adding ACON Flow Flex to Your CLIA Test Menu
The CLIA program has developed an email template that you can copy and paste, fill in the blanks, and email to CLIA@health.mo.gov to update your test menu to include ACON Flow Flex.
Email Subject line: Add COVID-19 Testing to existing CLIA Certificate for [FACILITY NAME]
| Lab/Facility Name: | |
| Existing CLIA Waived Lab #: | |
| Lab Director Name: | |
| Which COVID-19/ SARS-CoV-2 Waived Test system added? Check [X] all that may apply. |
[ ] Abbott BinaxNOW COVID-19 Ag Card |
|
As the Laboratory Director or administrator/owner’s agent of record for the CLIA facility holding a Waived Certificate identified above, I wish to append my facility’s existing CLIA# to include additional testing for COVID-19. I attest that my facility will provide reasonable assurances that:
All tests results (both positive and negative) will be reported to the proper public health entities under federal and state requirements. See MO DHSS link regarding reporting: https://health.mo.gov/living/healthcondiseases/communicable/novel-coronavirus/how-to-report-lab-results.php |
|