Justification and Approval_REDACTED.pdf

Justification and Approval (J&A) for Other Than Full and Open Competition

FOR OFFICIAL USE ONLY

March 2020 FOR OFFICIAL USE ONLY Page 2 of 5

I. Agency and Contracting Activity.

AFMS COVID-19 Lab Team 7700 Arlington Blvd Falls Church, VA 22042

773d Enterprise Sourcing Squadron (773 ESS)/PKA 3515 S. General McMullen, Ste. 200 San Antonio, Texas, 78226-1865

II. Nature and/or description of the action being approved.

AFMS requires access to BioFire Respiratory 2.1 (RP2.1) Panel with SARS-CoV-2 (COVID-19) Virus due to worldwide pandemic. This requirement provides for RP2.1 Panels in support of 73 BioFire FilmArray and 7 Torch analyzers across 42 Military Treatment Facilities in place for Home Station Medical Response programs, negating the need for mass equipment purchases. BioFire FilmArray and Torch analyzers were not procured centrally, but were decentralized by each MTF off of the Defense Logistics Agency's Medical Electronic Catalog program (ECAT) over the past few years. The ability to test for COVID-19 Virus on the BioFire analyzers is delivered via the reagent RP2.1 Panel. Without access to the appropriate reagent RP2.1 Panels the Air Force faces mission degradation across every MAJCOM. BioFire RP2.1 Panels are the only reagents compatible with BioFire FilmArray and/or Torch Analyzers. The BioFire FilmArray and Torch systems are not open platform molecular instruments, so other tests/reagents will not work on BioFire instrumentation. The FilmArray and Torch systems utilize a very specific “pouch” which in a fully automated fashion purifies the sample, extracts the nucleic acids, conducts a reverse transcriptase step to convert target RNA into DNA, does multiplex PCR, nested singleplex PCR, and finally a melting curve analysis and automated results reporting. The pouches are proprietary to BioFire and are not produced by other companies. BioFire is therefore considered sole source for FilmArray and Torch tests. 773 ESS intends to award a new, firm-fixed-price contract to fulfill this requirement based on a need date of 28 September 2020.

III. Description of supplies/services required to meet agency needs (including the estimated value).

This requirement provides for BioFire Respiratory 2.1 (RP2.1) Panels with SARS-CoV-2 in support of 73 BioFire FilmArray and 7 Torch analyzers across 42 Military Treatment Facilities in place for Home Station Medical Response programs.

RP2.1 Panels need to have the ability to detect SARS-CoV-2 via real-time Polymerase Chain Reaction (rt-PCR) methodology if present in an approved patient sample. Sensitivity and Specificity of test kits should be >90% (higher is better).

It is estimated that the unit price for BioFire RP2.1 Panels will be per 30-pack unit based on telephone and email contact with a BioFire sales account manager. It is estimated that , 30-pack units of BioFire RP2.1 Panels are needed to fulfill this requirement, for a total price of . Shipping and delivery costs vary for CONUS and OCONUS locations and quantities shipped; therefore a unit price of per 30-pack unit was utilized for development of the Independent Government Cost Estimate (IGCE). It is estimated that shipping and delivery will account for . The total estimated value of this requirement is .

BioFire is currently operating at maximum capacity. As such, RP2.1 Panels cannot be produced more quickly that what is being performed at this time. RP2.1 panels are on backorder and the full quantity cannot be shipped or delivered at one time. Therefore, BioFire will distribute RP2.1 Panels in accordance with a prioritized delivery schedule, with the final delivery occurring prior to 27 September 2021.

IV. Statutory authority permitting other than full and open competition.

FAR 6.302-1 - 10 USC 2304(c)(1), Only One Responsible Source and No Other Supplies or Services Will Satisfy

March 2020 FOR OFFICIAL USE ONLY Page 3 of 5

Agency Requirements

V. Demonstration that the contractor's unique qualifications or the nature of the acquisition requires use of the authority cited above (applicability of authority).

In accordance with FAR 6.302-1, there is only one responsible source and no other supplies will satisfy the Air Force's need for BioFire RP2.1 Panels. BioFire Defense, LLC (BioFire) is the manufacturer of reagent panels for verification of SARS-CoV-2 infection utilizing the BioFire FilmArray and Torch analyzers. BioFire RP2.1 Panels are the only reagent kits compatible with the AFMS's 73 BioFire FilmArrays and 7 Torch analyzers across 42 Military Treatment Facilities. The BioFire FilmArray and Torch systems are not open platform molecular instruments, so other tests/reagents will not work on BioFire instrumentation. The FilmArray and Torch systems utilize a very specific “pouch” which in a fully automated fashion purifies the sample, extracts the nucleic acids, conducts a reverse transcriptase step to convert target RNA into DNA, does multiplex PCR, nested singleplex PCR, and finally a melting curve analysis and automated results reporting. The pouches are proprietary to BioFire and are not produced by other companies. Due to the current crisis climate and the high demand/slow supply output, BioFire is not utilizing a distributor network. BioFire is therefore considered the sole source for FilmArray and Torch tests.

VI. Description of efforts made to ensure that offers are solicited from as many potential sources as practicable, including whether a notice was or will be publicized as required by subpart 5.2 and, if not, which exception under

FAR 5.202 applies.

This acquisition will require a Notice of proposed Contract Action (NOCA) in accordance with FAR 5.201. It is anticipated that a Sources Sought will be publicized at beta.SAM.gov on 10 September 2020 and last through 12 September 2020. In accordance with FAR 5.203(a)(2) a combined synopsis solicitation will be issued after the Sources Sought period has concluded.

VII. Determination by the Contracting Officer that the anticipated cost to the Government will be fair and reasonable.

It is determined that the anticipated cost to the Air Force will be fair and reasonable. It is estimated that the unit price for BioFire RP2.1 Panels will be per 30-pack unit; based on telephone and email contact with a BioFire sales account manager. Price analysis will be conducted prior to award to ensure fair and reasonable pricing.

VIII. Description of the market research conducted and the results, or a statement of the reasons market research was not conducted.

Market research conducted confirmed that BioFire is the manufacturer of BioFire RP2.1 Panels for verification of SARS-CoV-2 infection utilizing the BioFire FilmArray and Torch analyzers. BioFire RP2.1 Panels are only compatible with BioFire Film Arrays and/or Torch Analyzers. The BioFire FilmArray and Torch systems are not open platform molecular instruments, so other tests/reagents will not work on BioFire instrumentation. The FilmArray and Torch systems utilize a very specific “pouch” which in a fully automated fashion purifies the sample, extracts the nucleic acids, conducts a reverse transcriptase step to convert target RNA into DNA, does multiplex PCR, nested singleplex PCR, and finally a melting curve analysis and automated results reporting. The pouches are proprietary to BioFire and are not produced by other companies.

There are vendors that distribute BioFire testing products. Both Government Scientific Source and Dove Medical Supply offer BioFire products through the Defense Logistics Agency's Medical Electronic Catalog program (ECAT).

Additionally, there are BioFire products available through GSA Advantage. However, BioFire RP2.1 Panels are not offered under the ECAT program or GSA Advantage. Additionally, due to the current crisis climate and the high demand and slow supply output, BioFire is not utilizing a distributor network. BioFire is the sole manufacturer and distributor for the required BioFire RP2.1 Panels.

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On 10 August 2020, as part of the national response to COVID-19, the Department of Defense (DOD), in coordination with the Department of Health & Human Services (HHS), signed an agreement with BioFire Defense, LLC, a subsidiary of bioMérieux, to expand the production of the BioFire COVID-19 Tests for the DOD; $3.1M was allocated. The current COVID-19 pandemic created a global demand for diagnostic tests for the virus, including a requirement to maintain operational readiness and the health of our armed forces. The investment in BioFire Defense will enable the company to increase manufacturing capacity through expansion of its facility in Salt Lake City, Utah. By installing two new production lines, BioFire Defense will triple its manufacturing capacity of tests starting in September 2020, which are compatible for use with BioFire FilmArray instruments that are fielded across the DOD and Department of State.

The Joint Program Executive Office for Chemical Biological Radiological, Biological and Environmental (JPEO-CBRNE) has an enterprise contract for the DOD for single COVID-19 Test kits compatible for the BioFire FilmArray and Torch analyzers. However the Air Force's allocation of ~500 Test per week does not meet the Air Force's requirement of ~7000 per week. This need is based on the DOD Health Protection Guidance for Coronavirus Disease 2019 surveillance and screening with testing.

AFMS decided in August 2020 to pursue the acquisition of BioFire RP2.1 Panels as a way to increase the testing capability needed until the JPEO contract and BioFire production of COVID-19 single use tests increased the Air Force's allocation. Additionally, the COVID-19 JTF, has issued a CSO for nontraditional Test Manufactures. Several Approved FDA COVID-19 Test Manufacturers were identified, Mese Biotech, Accula, MiraDX, Biomeme, Cephiad.

Currently, 200 manufactures world-wide use the emergency use authorization for COVID-19 Tests. However, all tests require an investment of hardware and software in the form of test analyzers. Currently the AFMS fields 73 BioFire FilmArray and 7 Torch analyzers across 42 Military Treatment Facilities in place for Home Station Medical Response programs, negating the need for mass equipment purchases once BioFire RP2.1 Panels are acquired under this requirement.

IX. Any other facts supporting the use of Other Than Full and Open Competition.

The delivery of RP2.1 Panels is needed as soon as they can be produced by BioFire to meet the DOD surveillance and screening strategy in-order to break the chain of disease transmission and to reduce risk to the force and to DOD missions. The Services have been directed to employ health surveillance, screening, contract tracing and sentinel surveillance to decrease operation risk. Timely procurement and delivery of BioFire RP2.1 Panels is key to the Air Forces Heath Protect plan to reduce this risk.

X. List of any sources that expressed, in writing, an interest in the acquisition.

None. This acquisition will require a Notice of proposed Contract Action (NOCA) in accordance with FAR 5.201. It is anticipated that the aforementioned NOCA will be publicized between 10 September 2020 through 12 September 2020 in accordance with FAR 5.203(a)(2). BioFire is the manufacturer and sole source for the required BioFire RP2.1 Panels; the government does not anticipate any other sources to express interest in this acquisition.

XI. A statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before making subsequent acquisitions for the supplies or services required.

Prior to making any subsequent acquisitions for the supplies identified for this requirement, the government will determine if any distributors of the products exist. Furthermore, the government has determined that no suitable alternative or substitute products currently exist and will determine whether or not any suitable alternative or substitute products exist in future requirements for the detection of SARS-CoV-2 infection utilizing the BioFire FilmArray and Torch analyzers.

Furthermore, the DAF ACT Market Intel Team is working on opening another Area of Interest off the existing AFWERX CSO to identifying potential vendors that are capable of providing the Government with testing and

March 2020 FOR OFFICIAL USE ONLY Page 5 of 5 diagnostics capabilities in the future.

XII. Certification by the Contracting Officer.

As evidenced by my signature above, I have determined this document to be both accurate and complete to the best of my knowledge and belief.

XIII. Certification by the technical/requirements personnel.

As evidenced by my (our) signature(s) above, I (we) certify that any supporting data contained herein, which is my (our) responsibility, is both accurate and complete.