Redacted_J A.pdf

J&A Number: NMLC-15-10355

JUSTIFICATION AND APPROVAL FOR USE OF OTHER THAN FULL AND OPEN

COMPETITION

1. Contracting Activity.

This Justification and Approval (J&A) is executed by the Naval Medical Logistics Command

(NMLC), Fort Detrick, MD, on behalf of the requesting agency, Naval Medical Research Unit -

San Antonio (NAMRU-SA), 3650 Chambers Pass, JBSA Fort Sam Houston, TX 78234.

2. Description of the Action Being Approved.

Approval is requested to award a firm-fixed-price, indefinite delivery indefinite quantity contract on a sole source basis for the delivery of disposable products for use on the ROTEM® Delta analyzer for measuring thromboelastogrophy during hemorrhage resuscitation research. The proposed source is TEM Systems Inc. (TEM), Sunrise, FL.

3. Description of Supplies/Services.

The purpose of this acquisition is for the delivery of up to 20 Ex-TEM, 20 Fib-TEM, 20 Ap-

TEM, and 20 Star-Tem boxes or reagents, 300 Rotrol N and 300 Rotrol P Quality Control tests, 40 boxes of regular Cup n Pin Cuvette (330uL), 400 boxes MINI Cup n Pin Cuvette (105uL), 20 boxes of Pipette Tips.

Research, Development, Test and Evaluation (RDT&E) Fiscal Year 2015 and 2016 funds will be used to procure the reagents and disposables during the 12 month base period. There will also be four, 12-month option periods for a total estimated contract value of $1,603,233.00.

4. Statutory Authority Permitting Other Than Full and Open Competition.

10 U.S.C. 2304(c)(1), (as implemented by FAR 6.302-1); Only one responsible source and no other supplies or services will satisfy agency requirements.

5. Rationale Justifying Use of Cited Statutory Authority.

In accordance with FAR 6.302-1, TEM is the only vendor that manufacturers and distributes the supplies for the ROTEM® Delta analyzer used in the research protocols. This will ensure the scientific data generated is consistently run on the same devices, which is critical when comparing results within a protocol.

6. Description of Efforts Made to Solicit Offers from as Many Offerors as Practicable.

A sources sought notice was synopsized on the Federal Business Opportunities (FBO) website on 13 August 2015 and no additional sources expressed an interest in this requirement. No additional market research was conducted because it is not practicable for the reasons discussed in paragraph 5 above, for any company other than TEM to provide the required services.

Additionally, a notice of intent to award to TEM was also issued on the FBO website on 18

August 2015 for 15 days and no additional sources expressed an interest.

7. Determination of Fair and Reasonable Cost.

The contracting officer will perform a price analysis in order to determine that the anticipated price to the Government of the services covered by this J&A will be fair and reasonable. Pre-negotiated or audited rates will be used where available.

8. Actions to Remove Barriers to Future Competition.

For the reasons set forth in Paragraph 5, NMLC has no plans at this time to compete future contracts for the types of services covered by this document. If another potential source emerges, NMLC will assess whether competition for future requirements is feasible.

9. Contracting Point Of Contact.

The point of contact at NMLC is Mrs. Amber O’Bryan, Code 05, at DSN 343-8892, commercial

(301) 619-8892 or by e-mail at amber.n.obryan.civ@mail.mil.

See Approvals on Next Page mailto:amber.n.obryan.civ@mail.mil

TECHNICAL AND REQUIREMENTS CERTIFICATION

I certify that the facts and representations under my cognizance which are included in this Justification and its supporting acquisition planning documents, except as noted herein, are complete and accurate to the best of my knowledge and belief.

Technical Cognizance

Requirements Cognizance

LEGAL SUFFICIENCY REVIEW AND CONCURRENCE

I have determined this Justification is legally sufficient.

Julia P. Hatch Code 00L (301) 619-7491 Date

Office of Counsel

CONTRACTING OFFICER’S CERTIFICATION

I certify that this Justification is accurate and complete to the best of my knowledge and belief. To the extent that the J&A value is between $150K and $650K, the Contracting Officer’s signature below also represents approval of the J&A.

Emily K. O’Hara Code 02 (301) 619-9242 Date

Contracting Officer

COMPETITION ADVOCATE REVIEW

To the extent that the J&A value is between $650K and $12.5M, the Competition Advocate’s signature below also represents approval of the J&A/LSJ.

Darin L. Callahan Code 00 (301) 619-3095 Date

Competition Advocate