5_PR 1301293522 J_n_A BioFire signed.pdf

JUSTIFICATION AND APPROVAL

OTHER THAN FULL AND OPEN COMPETITION

1. Identification of the agency and the contracting activity.

This justification is executed by the Naval Medical Research Command (NMRC), Silver Spring, MD, on behalf of the Navy to meet Navy Expeditionary Medical Research requirements.

2. Nature and/or description of the action.

There is an urgent need for a BioFire Defense SpotFire Instrument. The instrument is manufactured by BioFire Defense LLC and has been selected to replace the currently deployed Biofire Defense FilmArray by the NAVY Fleet and US AirForce for Environmental monitoring. The Government intends on awarding a Firm Fixed Price contract for a single instrument. The proposed source is BioFire Defense LLC, 79 West 4500 South, Suite 14, Salt Lake City, UT, 84107.

3. Description of Supplies or Services:

The Molecular Diagnostics Department of the Biological Defense Research Directorate, Naval Medical Research Center has an urgent need to procure a BioFire Defense SpotFire Instrument.

Naval Medical Research Command overseas a profiency testing and competency assessment program including production of Profiency Test kits for the NAVY and AirForce. These profiency test kits are used to evaluate force readiness by the Proficeny Test program. The instrument has the ability to rapidly run BWsamples and accurately produce results. The BioFire Defense SpotFire Instrument is the only instrument selected capable of running this samples. It is critical that NMRC BDRD has a SpotFire Instrument to conduct the program.

Funds in the amount of $XX.XX will be used to procure this platform.

4. Identification of the statutory exceptions permitting other than full and open competition.

The statutory exception permitting other than full and open competition for this acquisition is 10 U.S.C. 2304(c)(1) and FAR 13.106-1(b)(1) soliciting from a single source.

5. Demonstration that the proposed contractor’s unique qualifications or the nature of the acquisition requires use of the authority cited.

The SpotFire Instrument produced by BioFire Defense is a proprietary platform that can only be procured directly through BioFire Defense. This instrument is employed by the Navy, and Airforce for the detection and identification of biological warfare agents which are deployed globally and therefore No other companies can supply the platform.

6. Description of efforts made to ensure that offers are solicited from as many potential sources as practicable.

Market research was performed through internet searches and approved government vendors to identify any and all alternative sources of procurement of the BioFire Defense SpotFire Instrument. The results are presented in paragraph 8. This requirement will be posted to the government point of entry in accordance with FAR 5.202.

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

The Contracting Officer shall determine the anticipated cost to the Government of the supplies/services covered by this Justification and Approval will be fair and reasonable by conducting a price analysis before an award is made. In addition, the Government anticipates that the negotiated contract price will reflect a discount from the BioFire Defense LLC commercial price list and will be determined to be fair and reasonable.

8. Description of the market survey conducted and the results, or a statement of the reasons a market survey was not conducted.

See accompanying Market Research Memorandum.

9. Other facts supporting the use of other than full and open competition.

As above, the only acceptable vendor for the instrument is BioFire Defense LLC.

10. Listing of Sources, if any, which expressed, in writing, an interest in the acquisition.

To date, no other sources have written to express an interest. Any sources expressing interest in response to the synopsis will receive consideration.

11. Statement of actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the supplies or services required.

Future requirements will be synopsized in accordance with FAR 5.203.

For the reasons set forth in Paragraph 5, NMRC has no plans at this time to compete future contacts for the instrument covered by this document. If another potential source emerges, NMRC will assess whether competition for future requirements is feasible.

12. Point of Contact:

The point of contact at the Naval Medical Research Command, Silver Spring, MD, regarding the contents of the sole source justification are the Contracting Officers in the Material Management Department (MMD) and can be reached by emailing usn.detrick.nmrc.mbx.mmd-contracts@health.mil.

mailto:usn.detrick.nmrc.mbx.mmd-contracts@health.mil mailto:usn.detrick.nmrc.mbx.mmd-contracts@health.mil

TECHNICAL AND REQUIREMENTS CERTIFICATION REQUIRED

BY NAVSUP 4200.83 series

I certify that the facts and representations under my cognizance which are included in this justification and approval and which form a basis for this justification are complete and accurate.

Technical Cognizance

Name: LCDR Stephen Lizewski Phone Date Title: Head, Molecular Diagnostics Department/Command: BDRD/NMRC

Requirements Cognizance

LIZEWSKI.STEPHEN.EU

GENE.1272396309

Digitally signed by

LIZEWSKI.STEPHEN.EUGENE.1272396309

Date: 2025.05.21 11:56:48 -04'00'

301-619-1507 21MAY2025

Name: LCDR Stephen Lizewski Phone Date Title: Head, Molecualr Diagnostics Department/Command: BDRD/ NMRC

CONTRACTING OFFICER CERTIFICATION

I certify that this justification is accurate and complete to the best of my knowledge.

Contracting Officer Phone Date

LIZEWSKI.STEPHEN.EUG Digitally signed by

ENE.1272396309

LIZEWSKI.STEPHEN.EUGENE.1272396309

Date: 2025.05.21 11:56:26 -04'00' 301-619-1507 21MAY2025