NMRC Sole Source_1276.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 Naval Medical Research and Development mission.

2. Nature and/or description of the action.

There is an urgent need for a BioRad CFX OPUS 96DX Instrument. The instrument is manufactured by Bio-Rad and has been down selected for evaluation to replace the

ABI7500FastDX PCR platfrom. The Government intends on awarding a Firm Fixed Price contract for a single instrument. The proposed source is Bio-Rad, 2000 Alfred Nobel Drive, Hercules, CA

94547.

3. Description of Supplies or Services:

The Molecular Department of the Biological Defense Research Directorate, Naval Medical

Research Command has an urgent need to procure a BioRad CFX OPUS 96DX Real-Time PCR instrument. The instrument has the ability to amplify and detect small amounts of nucleic acids from clinical and environmental samples through real-time fluorescence reporting. NMRC is the sole DoD producer of ISO certified PCR reagents for biological defense applications on real-time

PCR platforms. These reagents are employed by a variety of Navy, Department of Defense, and other US Government agencies including the Department of Homeland Security BioWatch

Program for the detection and identification of biological warfare agents. The BioRad CFX OPUS

96DX Real-Time PCR instrument is one of three platforms down selected by the DHS BioWatch

Program to replace the Applied BioSystems (ABI) 7500FastDX PCR platform. The ABI platform is being retired and the BioWatch Program has engaged NMRC and CDC to evaluate the BioRad

CFX OPUS 96DX Real-Time PCR instrument. The currently produced PCR reagents must be evaluated on the BioRad instrument to ensure that performance metrics of the PCR reagents are within acceptable parameters.

Funds in the amount of $XXXXX.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 CFX Opus 96DX Instrument produced by Bio-Rad is a propriatry real-time PCR platform and asssociated proprietary software that can only be procured directly through BioRad. No other companies can supply both the platform and software. XXXXXXXXX does distribute the platform only, but not the required computer and software necessary for the platform to function.

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 BioRad CFX Opus 96DX platforma and software. 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 Bio-Rad’s 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 Bio Rad.

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

Only XXXXXXX. has provided an estimate for the platform. However XXXXXXX is unable to provide the required computers and software. 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.

CARTER.SHAMAI.M.162 Digitally signed by

CARTER.SHAMAI.M.1624726649

Date: 2024.02.14 21:26:17 -05'00'

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.

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

LIZEWSKI.STEPHEN.EU

GENE.1272396309

Digitally signed by

LIZEWSKI.STEPHEN.EUGENE.1272396309

Date: 2024.02.05 15:24:42 -05'00'

Name LCDR Stephen Lizewski Phone 301-619-1507 Date 05FEB24

Title Depart Head

Department/Command Molecular Diagnostic Department

Requirements Cognizance

Name Phone Date

Title

Department/Command

CONTRACTING OFFICER CERTIFICATION

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

Contracting Officer Phone Date mailto:usn.detrick.nmrc.mbx.mmd-contracts@health.mil mailto:usn.detrick.nmrc.mbx.mmd-contracts@health.mil