Quidel Antigen JA - COVID_Redacted.pdf

JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION

Quidel Sofia 2 SARS Antigen FIA Test Kits and Analyzer

1. Defense Logistics Agency (DLA) Troop Support, Medical Supply Operations ECAT Division, is the contracting activity.

2. The action being approved is for the acquisition of Government requirements on an other than Full and Open competition basis in accordance with FAR 6.302-2.

3. The Government has the following estimated requirements for the corona virus rapid test manufactured by Quidel:

Item Description:

Sofia 2 Fluorescent Immunoassay Analyzer Including Virena Data Management System (P/N 20299) Sofia 2 Fluorescent Immunoassay Analyzer Install Pack (P/N 20314) Sofia 2 SARS Antigen FIA Test Kit (P/N 20374)

Estimated Dollar Value - Maximum Dollar Value - $49,413,244

The proposed contract will be a Fixed Price Indefinite Delivery/Indefinite Quantity contract with a performance period to begin from contract award through December 31, 2020. An Indefinite Delivery/Indefinite Quantity contract permits flexibility due to the evolving nature of the demand for the required items.

The estimated dollar value is based on current demand from both the Department of Defense (DoD) and Department of Health and Human Services (DHHS). The maximum dollar value of the proposed procurement is $49,413,244.00. The maximum dollar value includes possible unanticipated demand resulting from the unknown trajectory of the current COVID-19 Pandemic and the potential increase in COVID-19 hot spots across the United States.

4. The statutory authority permitting other than full and open competition is 10 U.S.C. § 2304(c)(2), Unusual and Compelling Urgency, as implemented by FAR 6.302-2.

5. The use of this authority is necessary to meet the urgent requirements from the DHHS and the DoD for coronavirus antigen rapid detection test kits and test instruments. The rapid detection tests provide results in minutes and allows for early detection of COVID-19. This action is critical to fill the immediate need for rapid testing to fight the spread of COVID-19 in nursing homes and long-term care facilities throughout the United States as well as various DoD facilities.

Almost 40% of all U.S.

COVID-19 deaths, are nursing-home related. The inability for both staff and residents to socially distance in nursing homes makes early detection critical in saving lives. The Centers for Disease Control and Prevention (CDC) recommends that nursing homes perform baseline testing of all residents and staff, followed by regular screening and surveillance through routine testing to detect potential outbreaks and minimize COVID-19 spread and COVID-19 related fatalities among their residents.

Any delay in getting the rapid detection kits could lead to additional fatalities.

DoD’s requirements for Quidel’s Sofia 2 Fluorescent Immunoassay Analyzer and Sofia 2 SARS Antigen FIA tests are in support of COVID-19 mitigation efforts and will be allocated accordingly to DoD facilities across the United States based on a need to test DoD personnel.

Whether it be on a ship, in a DoD Hospital, Submarine, Plane or on a base, it is critical that DoD personnel have the ability for rapid detection to fight the spread of COVID-19 as the threat of spread is much greater than in the average population due to a close quarter work environment.

Rapid detection will help combat the spread COVID-19, save lives and help prevent the spread throughout DoD.

To date, the Food and Drug Administration (FDA) ), as confirmed on its website by the Contracting Officer, has granted Emergency Use Authorization (EUA) for only two antigen detection tests for COVID-19: (1) the Sofia 2 SARS Antigen FIA manufactured by Quidel Corporation (Quidel) and (2) the Veritor TM System for Rapid Detection of SARS-CoV-2 manufactured by Becton Dickinson (BD). These assays are approved for detection of the nucleocapsid protein antigen from SARS-CoV-2. The Sofia 2 SARS Antigen FIA is EUA approved for detection in both nasal and nasopharyngeal swab specimens. The BD Veritor Rapid Detection of SARS-CoV-2 is EUA approved for detection in nasal swab specimens only. Both tests are authorized for use by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate to high complexity tests. In addition, these tests are authorized for use at the Point of Care (POC), i.e., in patient care settings such as nursing homes operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. Antigen tests can quickly detect fragments of proteins found on or within the virus by testing samples collected from the nasal and/or nasopharyngeal cavity using swabs. This type of test can provide results in minutes and, is very specific in the detection of COVID-19 unlike Polymerase Chain Reaction (PCR) tests, which can take up to 7 days to obtain results. The ability to receive results in minutes via the rapid response tests is critical against the spread of COVID-19. It is critical that both DoD and DHHS are able to acquire these tests as they are the only two tests to receive an EUA approval by the FDA for rapid antigen detection.

Due to this pressing, immediate need for antigen testing and the severity of the harm that will result, the Government’s requirements have an unusual and compelling urgency.

Quidel and BD are the only known sources that can immediately provide the required items to meet DHHS and DoD’s urgent needs.

A contract is anticipated to be issued in a short time-frame to include the DHHS and DoD requirements, upon approval of this J&A. Additional tests manufactured by BD will be procured via an urgent and compelling J&A under a separate contract within the same timeframe to meet DHHS and DoD’s urgent requirements..

6. Based on the unusual and compelling urgency of this requirement, the acquisition was not synopsized in accordance with FAR Subpart 5.2 in view of the exception at FAR 5.202 for urgent requirements. However, this justification will be made available for public inspection 30 days after award, in accordance with FAR 6.305(b).

7. As the Contracting Officer, I hereby determine that the anticipated prices and cost to the government will be fair and reasonable

8. Due to the urgent nature of the requirements in support of efforts to mitigate the COVID-19 pandemic, market research was not conducted.

9. Delaying the acquisition of these tests will cause harm to the Government

10. Quidel and BD are the only two companies that have been granted an EUA by the FDA for their antigen detection tests. For this reason, and due to the urgent nature of this requirement, there has not been an opportunity for additional manufacturers to express an interest in the proposed acquisition. Additional tests manufactured by BD will be procured under a separate contract to meet DHHS and DoD’s urgent requirements. A separate J&A will be executed for BD’s products.

11. The barriers to competition were not imposed by this agency, but are due to the urgent nature of the requirements in support of the COVID-19 mitigation efforts. There are, therefore, no effective measures that may be taken to reduce barriers to competition for these products.

12. As the Contracting Officer, I hereby certify that this justification is accurate and complete to the best of my knowledge and belief.

Date CHARLES T. REIMER

Contracting Officer

REIMER.CHARL

ES.T.1364950353

I hereby certify that the requirements which form the basis of this justification are accurate, that these supplies meet the Government’s needs, and that this justification is accurate and complete to the best of my knowledge and belief.

Date

Tech/Quality Specialist

I have reviewed this justification and recommend approval.

Date EILEEN C. MOTTA

Chief, ECAT Division

Date DANIEL KEEFE Director, Supplier Operations, Medical Supply Chain

Date ROBERT J. PANICHELLE

DLA Troop Support Competition Advocate

MOTTA.EILEEN

.C.1229098531

KEEFE.DANIEL

.P.1229191884

PANICHELLE.ROB

ERT.J.1229157139

I have reviewed this justification for legal sufficiency.

Date Supply Chain Counsel

DLA Counsel -Troop Support

I have reviewed and hereby approve this justification.

Date WILLIAM J. KENNY Executive Director DLA Troop Support Contracting and Acquisition Management

KENNY.WILLIA

M.J.1228968826

Digitally signed by

KENNY.WILLIAM.J.1228968826

Date: 2020.08.14 09:06:35 -04'00'