Hologic Supply Contract FY 2025 JA_7-11-2025.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.

The Naval Infectious Diseases Diagnostic Laboratory (NIDDL) is located at NMRC in Building

503. The lab is located in 3N60.

2. Nature and/or description of the action.

The items are needed for influenza, RSV, and Zika testing on Hologic Panther instrument for approximately 576 SARS-CoV-2/Influenza/RSV tests and 3,000 Zika tests. The supplies are specific and must be done in conjunction with each other for the test results to be of diagnostic grade and fulfilled

FDA emergency use authorization (EUA). This contract is set up to ship at different durations in order to ensure continuity of testing and reduce storage issues. Additionally, this contract contains a base year contract with 4 options years, with consistent pricing across all years.

3. Description of Supplies or Services:

The items are needed for influenza, RSV, and Zika testing on Hologic Panther instrument for approximately 576 SARS-CoV-2/Influenza/RSV tests and 3,000 Zika tests. The supplies are specific and must be done in conjunction with each other for the test results to be of diagnostic grade and fulfilled

FDA emergency use authorization (EUA). This contract is set up to ship at different durations in order to ensure continuity of testing and reduce storage issues. Additionally, this contract contains a base year contract with 2 options years, with consistent pricing across all years.

Navy Operation and Maintenance Fiscal Year 2025 funds in the amount of $XXXX will be used to procure these reagents.

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 items are available only from Hologic (see attached sole source letter). Any changes on the items used will cause the result to not be of diagnostic grade.

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

The items are available only from Hologic (see attached sole source letter). Any changes on the items used will cause the result to not be of diagnostic grade.

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 Hologic’s commercial price list and will be determined 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.

Research was done by internet and contacting vendors to get the quote and sole source letter.

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

If other suitable vendor(s) became available, a full and open competition may be considered.

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.

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.

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

Technical Cognizance

SILBERGER.DANIE Digitally signed by

L.JAMES.15494159

SILBERGER.DANIEL.JAMES.15

301-319-7669 4/9/2025

69 Date: 2025.04.09 16:54:12 -04'00'

Name Phone Date

Title

Department/Command

Requirements Cognizance

SILBERGER.DANIE Digitally signed by

L.JAMES.15494159

SILBERGER.DANIEL.JAMES.15

301-319-7669

69 Date: 2025.04.09 16:55:39 -04'00'

Name Phone Date

Title

Department/Command

CONTRACTING OFFICER CERTIFICATION

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

301-319-9948 Jul 02, 2025

Contracting Officer Phone Date

49415969

49415969