J&A_REDACTED_fbo_Redacted.pdf

ADVFY19RD100046

Log #19-10029

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, Maryland, on behalf of the requesting activity, Naval Medical Research Unit-San Antonio (NAMRU-SA), located in San Antonio, Texas.

2. Description of the Action Being Approved.

Award of a firm-fixed-price indefinite-delivery indefinite-quantity (IDIQ) with economic price adjustment on a sole source basis to Werfen USA, LLC for the delivery of disposable consumables, reagents, and supplies for Rotational Thromboelastometry (ROTEM®) Delta Analyzers. The proposed source is Werfen USA, LLC (known in industry as Instrumentation Laboratory (IL) – a Werfen Company) located at 180 Hartwell Rd, Bedford, MA 01730-2443 (CAGE code: 22270).

3. Description of Supplies/Services.

NAMRU-SA requires the delivery of disposable consumables, reagents, and supplies for ROTEM® Delta Analyzers to evaluate and assess coagulation, platelet function, clots strength, and fibrinolysis in hemorrhage and shock models. The requirement includes: delivery of up to 90 ex-TEM boxes (10 vials x 10 tests ), 70 fib-TEM boxes (10 vials x 5 tests), 70 ap-TEM boxes (10 vials x 5 tests) , 50 star-TEM boxes (10 vials x 20 tests), 52 ROTROL N quality control boxes, 52 ROTROL P quality control boxes, 100 Pro Cup & Pin Cuvettes (330uL), 80 Mini Cup & Pin Cuvettes (105uL), 25 tip tray boxes, 10 e-line filter packs, 10 plastic clip cup holder, 10 dust filters, 10 cup holder pros, 10 mini cup holders, 10 MC-rods, and 10 mini MC-rods per period.

The period of performance for this contract is anticipated to be a base period of 12 months followed by four 12-month option period(s) for a total of 60 months.

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

The statutory exception permitting other than full and open competition for this acquisition is 41 U.S.C. 1901 (see also FAR 13.501(a)).

5. Rationale Justifying Use of Cited Statutory Authority.

NAMRU-SA utilizes several ROTEM® Delta analyzers which require disposables compatible with the equipment.

Currently, only original equipment manufacturer (OEM) disposables are compatible with ROTEM® Delta analyzers.

Werfen USA, LLC is the OEM of the ROTEM® Delta analyzer and does not have any authorized distributors or resellers of their products; refer to Enclosure (1) – Werfen USA, LLC sole source documentation

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

A notice of intent to sole source was synopsized on the FEDBIZOPS website for 15 days (11-27 June 2019) and no other potential 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 Werfen USA, LLC to provide the required supplies and services.

7. Determination of Fair and Reasonable Cost.

The Contracting Officer has determined the anticipated cost to the Government of the supplies/services covered by this J&A will be fair and reasonable.

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 type of supplies/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 Naval Medical Logistics Command is Sarah Ream, Code 05, at DSN 343-0727, commercial

(301) 619-0727 or by e-mail at sarah.e.ream.civ@mail.mil.

See Approvals on Last Page

Enclosure (1) – Werfen USA, LLC sole source documentation

CERTIFICATIONS AND APPROVAL

REMOVED FOR POSTING PURPOSES