4.2 Urgency Justification FY25 (Werfen; GEM4000 Repair) rev.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.

3. Description of Supplies or Services.

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

As of 19 May 2025

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

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

Market research was performed, the results of which are 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.

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

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

Not applicable

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

Not applicable

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.

For the reasons set forth in Paragraph 5, (contracting activity) has no plans at this time to compete future contacts for the types of supplies/services covered by this document. If another potential source emerges, (NMRC) will assess whether competition for future requirements are 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 POC

Phone Date Name Title Department/Command

Department Head

Phone Date Name 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

Technical Cognizance

Director

EHEL/NAMRU-D

Lab Manager/Research Biologist

EHEL/NAMRU-D

There is only 1 potential supplier that can fulfill this request. The manufacturer is Werfen USA.

The technology was developed by Werfen and is proprietary to their company and instrument(s).

Text3: 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 Tecan’s commercial price list and will be determined fair and reasonable.

NAMRU Dayton; Environmental Health Effects Laboratory (EHEL) currently owns a Werfen GEM4000 blood gas analyzer. Current Animal Protocol 0226 (Silica Nose Only Exposures) is needing to utilize this analyzer to measure multiple blood gas parameters in whole blood samples. Currently, the analyzer is in need of service and replacement parts (labor and Co-Ox hardware module), which can only be performed by the manufacturer of the instrument. Without this repair, the protocol will not be able to provide crucial data to the sponsor. This is a current work stoppage.