ERP PR 1301153125 JA-redacted_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.

2. Nature and/or description of the action.

The proposed action is a service contract for preventive maintenance on the BIOTEK Synergy

HTX ELISA washer Instrument SN: 19061328 to be used in the Naval Infectious Diseases

Diagnostic Laboratory. The service provides coverage for the repair, parts, labor, travel, as well as one planned preventive maintenance service at your facility. The Government intends on awarding a Field Service contract. The proposed source is Agilent Technologies (previously

BIOTEK Instruments Inc.) at XXXX XXXXXXX XXXX, Wilmington, DE 19808.

3. Description of Supplies or Services:

The Naval Infectious Diseases Diagnostic Laboratory has a critical need to have a preventive maintenance for their BIOTEK Synergy HTX Reader Instrument SN: 19061328. It is necessary for a preventive maintenance to be set up in order for the laboratory to maintain its laboratory accreditation from the College of American Pathologist (CAP) and for the laboratory to receive

501 (k) clearance from the FDA for in vitro diagnostic use. BIOTEK Synergy HTX Reader

Instrument SN: 19061328 is required to be calibrated annually by Agilent Technologies

(previously BIOTEK Instruments Inc.), as they are the manufacturer and sole distributor of the instrument, thus they are the only company who can provide the repair and maintenance service for this instrument.

Navy Operation and Maintenance Fiscal Year 2024 funds in the amount of $XX,XXX.XX will be used to maintain the instrument to diagnosic standards.

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.

BIOTEK Synergy HTX Reader Instrument SN: 19061328 is required to be calibrated annually by Agilent Technologies (previously BIOTEK Instruments Inc.), as they are the manufacturer and sole distributor of the instrument, thus they are the only company who can provide the repair and maintenance service for this instrument (see sole source letter).

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

BIOTEK Synergy HTX Reader Instrument SN: 19061328 is required to be calibrated annually by Agilent Technologies (previously BIOTEK Instruments Inc.), as they are the manufacturer and sole distributor of the instrument, thus they are the only company who can provide the repair and maintenance service for this instrument (see sole source letter).

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 Agilent Technologies

(previously BIOTEK Instruments Inc.) 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.

Agilent Technologies (previously BIOTEK Instruments Inc.) is the manufacturer and sole distributor of the instrument and the only company who can provide the repair and maintenance service for this instrument. It will not be cost-effective, time-effective or advantageous to develop a competitive package for maintenance contract for a critical equipment.

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.

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.

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

LCDR Sarah Jenkins Department Head

DSD/NMRC

Requirements Cognizance

Phone Date

LCDR Sarah Jenkins

Department Head

DSD/NMRC

Phone Date

CONTRACTING OFFICER CERTIFICATION

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

CARTER.SHAMAI.M.

1624726649

Digitally signed by

CARTER.SHAMAI.M.1624726649

Date: 2024.04.19 06:35:33 -04'00'

Contracting Officer Phone Date

JENKINS.SARAH.ANN.1 Digitally signed by

500933581

JENKINS.SARAH.ANN.1500933581

Date: 2024.04.04 08:52:28 -04'00'

JENKINS.SARAH.A Digitally signed by

NN.1500933581

JENKINS.SARAH.ANN.1500933581

Date: 2024.04.04 08:52:39 -04'00'