NMRC JA BIOTEK Synergy HTX 2021 (003).pdf

NMRC

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 Center (NMRC), Silver Spring, MD, on behalf of the Navy to meet Naval Medical Research and Development mission.

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 BIOTEK Instruments Inc. in Highland

Park, PO BOX 998, Winooski, VT 05404-0998.

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 ELISA washer 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

ELISA washer Instrument SN: 19061328 is required to be calibrated annually by 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 2021 funds in the amount of $3,672.00 will be used to procure the service contract.

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.

BIOTEK Synergy HTX ELISA washer Instrument SN: 19061328 is required to be calibrated annually by 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.

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

Yes. Market research was conducted and 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

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 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.

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 Center, 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

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.

Deborah M. Sharpe Phone Date Contracting Officer

Edilberto P. Calma Phone Date Contracting Officer