NMRC JnA 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.

The Diagnostics and Surveillance Department (DSD) is located at NMRC in Building 503. The lab is located in 3N54.

2. Nature and/or description of the action.

Olink® Signature Q100 is needed to perform multiplex immunoassays utilizing small sample volumes. The Q100 will be used in ongoing projects looking for biomarkers of disease severity, vaccine effectiveness and long term sequala of infection. The assay utilizes Proximity Extension

Assay (PEA) technology measure up to 96 proteins using less than 1μL of sample. NMRC does not currently have this capability.

3. Description of Supplies or Services:

The item is needed in support of projects on post-acute sequelae of COVID-19 (PASC) among CHARM participants and a collaborative study with NAMRU-South looking for biomarkers of

Dengue infection in Iquitos Peru. The item will also be used for future and ongoing projects examining correlates of disease and protection.

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 item is available only from Olink®. There are no other available items the meet the multiplex and sample volume requirements.

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

Market research was performed, there are no other available items the meet the multiplex and sample volume requirements.

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.

A search was conducted in the January 2024 timeframe by internet and by contacting vendors.

Olink. is the sole manufacturer and reseller. Consequently, Olink is the only source that can meet the Government’s requirements.

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.

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, NMRC 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 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 , Deborah M. Sharpe, who may be reached at (301)

319-6471 or Edilberto Calma 301-319-6481.

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

LCDR Sarah A Jenkins Phone Date Department Head

DSD/NMRC

Requirements Cognizance

LCDR Sarah A Jenkins Phone Date Department Head

DSD/NMRC

CONTRACTING OFFICER CERTIFICATION

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

Deborah M. Sharpe Phone Date Contracting Officer

Edilberto P. Calma Phone Date Contracting Officer