Abbott Addendum to JA - Redacted_Redacted.pdf

ADDENDUM TO JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION

Abbott Coronavirus Rapid Detection Tests

Reference: Justification For Other Than Full And Open Competition For Abbott Coronavirus Rapid Detection Tests, approved by Senior Procurement Executive on August 27, 2020.

1. This addendum to the referenced Justification For Other Than Full And Open Competition (J&A) is necessary to expand the scope of the Government’s requirement for the Abbott BinaxNOW™ COVID-19 tests beyond those described in the J&A. The expansion of the scope is critical to fill the immediate need for rapid testing of additional vulnerable and high risk populations and the immediate need for testing in situations where a COVID-19 outbreak would create special or unique public safety or security risks. These populations and situations require a self-contained test that is easier to administer due to the harsh, challenging, and/or unpredictable conditions in which the testing will occur, or the individuals being tested are challenging to test by other means. A test requiring a separate analyzer would create logistics and administration difficulties for these populations and in these situations. The Department of Health and Human Services (DHHS) initially identified K-12 school children as the individuals who would be tested with the BinaxNOW tests. However, given the existence of other vulnerable, high risk populations and special or unique situations with an urgent need for testing, DHHS has expanded the scope beyond that in the J&A to include additional populations and situations. The anticipated populations and situations will include but are not limited to individuals at colleges/universities, certain hospitals, natural disasters, certain nursing homes, as well as other testing in situations possessing special or unique public safety or security risks which confront federal, state, and local government entities.

2. The BinaxNOW test is a self-contained COVID-19 test that does not require a separate analyzer to administer. According to the Food and Drug Administration (FDA) website, the BinaxNOW is the only point-of-care antigen detection test for rapid detection of COVID-19 with Emergency Use Authorization (EUA) approval that does not require a separate analyzer (a larger, more complex piece of hardware).

The self-contained nature of the BinaxNOW test and the ease of its use and administration make it optimally suited for testing in vulnerable and high risk populations. The Binax Now test is extremely portable due to the fact that is does not require a separate analyzer. In addition, the Binax Now test process is much simpler than the process for other EUA approved antigen detection tests for rapid detection of COVID-19. There are less steps necessary to perform the BinaxNOW test, and the required steps are less complex, which adds to the ease of use and administration. Abbott is the only known source that can deliver a self-contained, simple to use test to the vulnerable and high risk populations and to situations where COVID-19 would create special public safety or security risks in order to meet the needs of the immediate and rapidly expanding requirement.

3. In response to the pandemic, DHHS is using the BinaxNOW tests to help detect potential outbreaks and minimize COVID-19 spread in the populations that are highly vulnerable or in situations in which outbreaks would create special or unique public safety or security risks. In the event that the other EUA approved antigen detection tests for rapid detection of COVID-19 are not available, DHHS will also use the BinaxNOW tests to meet other testing requirements in addition to the highly