Redacted_JA.pdf

Control No: JA16083

"For Official Use Only”

Sole Source Justification (SSJ) in accordance with FAR subparts 13.106 or 13.5 using Simplified Acquisitions Procedures (SAP)

1. Contracting Activity:

This is a Sole Source Justification for an acquisition conducted by the U. S. Army Medical Research Acquisition Activity (USAMRAA). USAMRAA Contract Specialist is Jeff Sprecher 820 Chandler Street, Fort Detrick MD 21702.

2. Requiring Activity:

The US Army Institute of Surgical Research (USAISR) Fort Sam Houston, TX 78234.

3. Nature of Action:

Commercial Item Non-Commercial Item New Requirement Follow-on Requirement Mod to Existing Purchase Order/Contract Number

Pricing: Firm-Fixed Price Time & Materials Cost

Funds: RDT&E Operations and Maintenance, Army (OMA) Other Funds:

Fiscal Year of Funds: _FY 16___

Estimated Total Dollar Value including Options: $ _

"For Official Use Only”

4. Contractor Name:

Name of Proposed Contractor: TEM Systems Inc Address: 3210 E Nc Highway 54 Suite 150, Durham, NC 27709 Phone: 919-941-7777

DUNS: 828101258

Cage Code: 56AL4

5. Description of Supplies/Services:

USAISR has a need for a Blanket Purchase Agreement (BPA) for consumable supplies (cups-and-pins, InTEM, ExTEM, FibTEM, Rotrol-N, Rotrol-P, and Star-TEM) for use with the ROTEM delta coagulation analyzer totaling over a 5-year ordering period from TEM Systems, Inc.

6. Authority Cited: 41 U.S.C. 1901

(a) FAR 13.106-1(b)(1)(i): Only one source reasonably available (e.g., urgency, exclusive licensing agreement, brand name or industrial mobilization); OR

(b) FAR 13.106-1(b)(1)(ii): Only one source can provide a portion of the purchase that is a particular brand-name item; OR

(c) FAR 13.501(a)(1)(i): Only one source reasonably available (including brand name); OR

(d) FAR 13.501(a)(1)(ii): Only one source can provide a portion of the purchase that is a particular brand-name item.

7. Reason for Authority Cited: ISR currently has in use 10 ROTEM delta coagulation analyzers. These units support numerous research protocols across 4 task areas.

Various reagents, controls, and disposable supplies are required to process samples on these devices. The ROTEM instruments are FDA approved, but only with the use of original manufacturer supplied consumables. These consumables are specific to the instruments and generic reagent substitutions are not validated nor will the manufacturer support the use of such supplies on the instruments. There are no generic disposable supplies available. Additionally, these consumable supplies will be used to support ongoing protocols which used these exact supplies since initiation. Consistency of results is paramount to our research efforts. The volume of supplies required continues to be above credit card purchase limits.

8. Efforts to obtain Competition:

a. Effective competition. Notice of Intent to Sole Source will be posted to FBO, notifying the market of the Government’s intent to award a sole source contract to TEM Systems for the Rotem consumable supplies.

"For Official Use Only”

b. Subcontracting competition. N/A

9. Actions to remove or overcome barriers Competition:

Market research will be conducted for future requirements to identify all possible sources of Rotem consumable supplies, including the use of CHESS/ESI, GSA, and other open market sources. Reasonable effort will be made to collect price information, points of contact, and business status for all identified sources.

10. Market Survey: Market research was done on the internet (google.com, bing.com, biocompare, and pubmed) and no other company sells these supplies in the US.

Contract Specialist confirmed with TEM Systems that they are the only source and they do not have any authorized resellers.

11. Interested Sources: TEM Systems was the only source that replied to the posted Sources Sought – RFI.

12. Procurement History and any other facts:

Previous Contract or Purchase Order Number:

-W81XWH-12-P-0018

-W81XWH-12-A-0012 (JA12195)

-W81XWH-15-P-0584 (JA15403)

Previously competed? N/A

Previous authority for less than Full & Open Competition: Sole Source

"For Official Use Only”

13. Technical / Requirements Certification: I certify that the support data under my cognizance which are included in this SSJ are accurate and complete to the best of my knowledge and belief.

14. Contracting Officer Certification and Approval: I certify that this justification is accurate and complete to the best of my knowledge and belief. Based upon the facts described herein, I hereby determine that the anticipated price/ cost to the Government will be fair and reasonable, and a determination of price reasonableness will be documented and placed in the contract file.