NMRC JAA_1301218039_KOSigned.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.

The proposed action is a service contract for preventive maintenance on two Qiagen EZ1 intruments to be used in the Naval Infectious Diseases Diagnostic Laboratory. The Government intends on awarding a Field Service contract. The proposed source is Qiagen 19300 Germantown

Road, Germantown, Maryland 20874-1415.

3. Description of Supplies or Services:

This service agreement will:

1. Provide routine preventative maintenance visit

2. Provide unlimited repair services in a competent and efficient manner

3. Supply replacement parts free of charge

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 6.302-1 sole source (including brand name) acquisitions OR 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 Qiagen EZ1 is required to be serviced and gets their parts checked, replaced, and calibrated as necessary by Qiagen. Only the personnel trained by this company can meet the standard of the services and repair.

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

A Qiagen representative was contacted and confirmed that the servicing of the EZ1 instrument must only be performed by a Qiagen Instrument Service Specialist, as Qiagen is the manufacturer and sole distributor of the instrument and the only company who can provide the repair and maintenance service for this instrument (see sole course letter). While one additional company was contacted, it was noted that companies outside of Qiagen do not cover all service parts, can not guarantee a technician on-site in a certain amount of time after a problem arises, and do not have access to proprietary service software and patches. Therefore, Qiagen is the only suitable source for this contract.

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 Qiagen 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.

A Qiagen representative was contacted and confirmed that the servicing of the EZ1 instrument must only be performed by a Qiagen Instrument Service Specialist, as Qiagen is the manufacturer and sole distributor of the instrument and the only company who can provide the repair and maintenance service for this instrument. Companies other than Qiagen, the manufacturer and sole-source provider for maintenance, are not suitable for this contract, as they do not guarantee compliance around manufacturer-recommended planned maintenance schedules, nor the equipment would be serived by OEM technicians, which is necessary in a clinical diagnostic laboratory setting.

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

N/A

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

N/A

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.

N/A

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.

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

HALL.ERIC.REESE.1037970383

Digitally signed by

HALL.ERIC.REESE.1037970383

Date: 2025.01.03 12:56:37 -05'00'

Name Phone Date

Title

Department/Command

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.

(301) 319-7182 1/10/2025

Contracting Officer Phone Date