Control No: 17057 Sole Source Justification (SSJ) in accordance with FAR subparts 13.106 or 13.5 using Simplified Acquisitions Procedures (SAP) 1. Contracting Activity: The contracting activity responsible for this action is the U.S. Army Medical Research Acquisition Activity (USAMRAA), 820 Chandler Street, Fort Detrick, MD 21702 2. Requiring Activities: The U.S. Army Research Institute of Environmental Medicine (USARIEM), 10 General Greene Avenue, Natick, MA 01760, and The U.S. Army Institute of Surgical Research (USAISR) 3698 Chambers Pass, Ft Sam Houston, TX 78234. 3. Nature of Action: 1 Commercial Item 0 Non-Commercial Item 0 New Requirement 0 Follow-on Requirement 0 Mod to Existing Purchase Order/Contract Number Pricing: 1 Firm-Fixed Price* 0 Time & Materials** 0 Cost* * See FAR 12.207(a) ** See FAR 12.207(b). For Hybrid Contracts, list percentage of each type of pricing: * Firm Fixed Price: ________ **Time & Materials: ________ * Cost: ________ Funds: 1 RDT&E 0 Operations and Maintenance, Army (OMA) 0 Other Funds: Fiscal Year of Funds: __TBD on each call order __ Estimated Total Dollar Value including Options: BPA Ceiling $ 2,500,000.00 4. Contractor Name: Name of Proposed Contractor(s): Siemens Healthcare Diagnostics Street Address: 511 Benedict Avenue City, State, Zip: Tarrytown, NY 10591 Phone:
+1 (555) 000-0000 DUNS: 798318598 Cage Code:1K2V6 5. Description of Supplies/Services: The US Army Research Institute of Environmental Medicine (USARIEM) and US Army Institute of Surgical Research (USAISR) have a reoccuring need for reagents and supplies for the Siemens Healthcare Dimension Xpand Plus and Siemens Healthcare Immulite 2000 clinical chemistry analyzers. This justification is to support a Blanket Purchase Agreement with a five year ordering period. 6. Authority Cited: 1 41 U.S.C. 1901 OR 0 41 U.S.C. 1903 0 (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 0 (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 1 (c) FAR 13.501(a)(1)(i): Only one source reasonably available (including brand name); OR 0 (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: The purchase of reagents and supplies is for two clinical chemistry analyzers: the Siemens Healthcare Dimension Xpand Plus and Siemens Healthcare Immulite 2000. The Dimension Xpand Plus was purchased for USARIEM for $86,280.25 under contract W91QUZ-11-P-0631 on 1 Sept 2011. The Immulite 2000 was purchased for USARIEM for $86,735.00 under contract W81XWH-13-P-0351 on 8 July 2013. USAISR purchased their Siemens' Dimension equipment under W81XWH-16-P-0107 for $106,502.51 on 9 Feb 2016. These instruments are in currently in-use in USARIEM and ISR's Central Laboratory providing sample analysis for ongoing and future human research studies. Both instruments perform a wide variety of clinical chemistry analysis using proprietary, premade kits and reagents. These types of analyses provide a scientifically accurate, valid and rapid test results. Numerous current and future protocols rely upon these instruments to conduct their sample analyses. The reagents and supplies requested represent the ongoing consumables for these studies. Additionally, to reduce variability and yield more accurate research results, the samples are batched and run concurrently. Batching of samples is a critical element when assaying research samples. Samples are banked until study completion or the end of a study group. They are then all measured as one batch. There is always variability when you put new reagents on, recalibrate, or even the age of reagents. In an effort to reduce the variability, the labs run as much as possible at one time. Because sample analyses are performed concurrently, kits are utilized in batches which require purchase from a single vendor. The reagents and supplies requested are produced solely for use in these specific instruments manufactured by Siemens Healthcare Diagnostics. No other vendor can supply the wide variety to tests reagents, controls, and kits for these instruments. No other vendor can offer the scientific and clinical validity of these tests. 8. Efforts to obtain Competition: Siemens is the only vendor which produces the fully array of kits and reagents for the Dimension Xpand Plus and Immulite 2000 clinical chemistry systems. a. Effective competition. Siemens is the only vendor which produces all the reagents required for current USARIEM and USAISR projects. b. Subcontracting competition. N/A 9. Actions to remove or overcome barriers Competition: Siemens is the only current source. When the current equipment is at end of life USARIEM and USAISR will determine if acceptable substitutes exist. 10. Market Survey: Market research was conducted via Internet searches to attempt to identify if other manufacturers of reagents and supplies for these Siemens Healthcare Instruments exist. The results found no other manufacturers which could provide all the reagents required. A few resellers were identified which only resell very limited numbers of items of the Siemens manufactured products. Due to the batching of analysis, it is required all the items be purchased and delivered from a single source. 11. Interested Sources: There are no known other sources which can provide all the products listed. 12. Procurement History and any other facts: Previous Contract or Purchase Order Number: N/A Previously competed? N/A Previous authority for less than Full & Open Competition: N/A
