ERP 1301287517_JNA_Redacted.pdf

NMRC

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 the Naval Medical Research and Development mission.

2. Nature and/or description of the action.

The need is for customized 5mm assay cartridges and magnifiers. The Government intends on awarding a Firm Fixed Price contract. The proposed source is HDT Expeditionary Systems, Inc.

30500 Aurora Road, Suite 100, Solon, Ohio 44139.

3. Description of Supplies or Services:

The Immunodiagnostic Department of the Biological Defense Research Directorate, Naval

Medical Research Command develops, produces, and deploys hand-held rapid assays for the detection of non-nucleic acid biological molecules. The Department’s products are recognized as critical for the Department of Defense and are used widely among many US Government

Agencies. The assay cartridge sets and magnifiers are an integral and essential component of these assays and must conform to strict standards and measurements.

Funds in the amount of $92,500.00 will be used to purchase the custom 5mm cartridge sets and magnifiers.

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.

HDT has successfully manufactured the cartridge sets in the past and has the capability to custom engineer and manufacture the necessary sets. Developing the mold to the correct specifications required many months of development and testing.

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

Other suppliers do not manufacture the required products. This requirement will be posted to

SAM.gov as a Special Notice 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.

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

Market research was conducted by technical experts which is documented in a market research memorandum. That market research concluded that this vendor’s unique qualifications fulfills the requirement for strict conformity to measurements, standards, and performance.

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

As above, HDT has produced the assay cartridges in the past and is in the best position to fulfill the requirement. Previous similar purchases include PO’s N32398-13-P-0337, N32398-16-P-

0212, N32398-20-P-0015, and N32398-21-P-0334.

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.

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 types of services 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 is the Contracting Branch of the Material Management

Department who can be reached at email: 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

(301) 619-1329

Darci R. Smith, PhD Date Phone

Department Head

Immuno/BDRD/NMRC

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.

9/3/2025 301-319-9955

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