JA16072_Redacted.pdf

Control No: JA16072

"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 Terry Bice, 820 Chandler Street, Fort Detrick MD 21702.

2. Requiring Activity:

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 15___

Estimated Total Dollar Value including Options: $ _649,000.00 __

4. Contractor Name:

Name of Proposed Contractor: Diapharma Group, Inc.

Address: 8948 Beckett Road, West Chester, OH 45069-2939 Phone: 800-526-5224

DUNS: 966721706

Cage Code: 1LRC6

5. Description of Supplies/Services:

USAISR has a need for a Blanket Purchase Agreement (BPA) for consumable supplies (see table below) for use with the Diapharma Multiplate platelet aggregometer totaling $649,000.00 over a 5-year ordering period.

Product Name Cat. Number Multiplate System MP0010, MP0030 Sensor cable MP0360 Hirudin vacuum collection tube MP0600 Liquid Control (for 5 LC1 and 5 LC2 replicates) MP0720 0.9% NaCl / 3.0mM CaCl2 Solution MP0530 Multiplate mini test cells (60 cells) MP0028 Multiplate test cells (60 cells) MP0027 ASPItest micro tubes MP0091 ASPItest kit (150 tests) MP0210 ADPtest micro tubes MP0092 ADPtest kit (150 tests) MP0220 COLtest micro tubes MP0093 COLtest kit (150 tests) MP0230 RISTOtest micro tubes MP0094 RISTOtest kit (60 tests) MP0240 TRAPtest micro tubes MP0095 TRAPtest kit (150 tubes) MP0250 Prostaglandin E1 micro tubes MP0096 Prostaglandin E1 kit (150 tests) MP0260 ASA Control micro tubes MP0097 ASA Control kit (150 tests) MP0270 GPIIb/IIIa Antagonist, 50microgram/ml (25 tests) MP0520

GPIIb/IIIa Antagonist, 50microgram/ml (75 tests) MP0280

PAR-4 Agonist + 5 micro tubes (50 tests) MP0549 von Willebrand Factor reagent + 5 micro tubes (50 tests) MP0548

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:

USAISR currently has eleven Multiplate aggregometers in operation. These units support numerous research protocols. Various reagents, controls, and disposable supplies are required to process samples for analysis. Diapharma offers instrument support, but only with the use of original manufacturer-supplied consumables. These consumables are specific to the instruments and generic substitutions are not validated nor will the manufacturer support the use of such supplies on the instruments.

Reference ranges and calibrations are done using OEM consumables, and no other manufacturer supplies the required reagents in a form suitable for use in these instruments. Furthermore, there is no other company offering generic consumables that will work in these systems. The volume of supplies consumed continues to be at a level that warrants a Blanket Purchase Agreement (BPA).

8. Efforts to obtain Competition:

a. Effective competition. A sources sought notice was posted on FBO.gov for eight days with no responses received.

b. A Notice of Intent to Sole Source will be posted on FBO, notifying the market of the Government’s intent to award a sole source contract to Diapharma Group, Inc. for the Multiplate platelet aggregometers.

c. 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 Multiplate 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 (diapharma.com, google.com, biocompare, and pubmed) and no other company sells or distributes these supplies in the US. The Contract Specialist has confirmed with Diapharma that it is the only source and it does not have any authorized resellers.

11. Interested Sources: No other source replied to the posted Sources Sought – RFI, nor has any source expressed an interest in this requirement.

12. Procurement History and any other facts:

Previous Contract or Purchase Order Number:

W81XWH-13-A-0001

Previously competed? Sole Source J&A

Previous authority for less than Full & Open Competition: N/A

10 United States Code 2304(c)(1) as Implemented in Federal Acquisition Regulation 6.302-1(a)(2)(iii)(B)

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.

Submitted by Signature:

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.

Contracting Officer Signature: