Scanco_SSJ_Redacted.docx

MCMR-AAP-A

SUBJECT: USAMRAA Policy 16-08, Sole Source Justifications (SSJ) in accordance with FAR Subparts 13.106 or 13.5 using Simplified Acquisitions Procedures (SAP)

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

Control No: JA17103

1. Contracting Activity:

The contracting activity for this action is the US Army Medical Research Acquisition Activity (USAMRAA), Fort Detrick, MD 21703.

2. Requiring Activity:

US Army Research Institute of Environmental Medicine (USARIEM) 10 General Greene Avenue, Natick, MA 01760.

3. Nature of Action

Mod to Existing Purchase Order/Contract Number

Pricing: Firm-Fixed Price Time & Materials Cost

Fiscal Year of Funds: 2016-2017

4. Contractor Name:

Scanco USA, Inc.

985 Old Eagle School Road STE 511 Wayne, PA 19087-1712

DUNS #: 053170671

Cage Code: 393T7

5. Description of Supplies/Services: Lease of one (1) Xtreme CT II Bone Scanner with an option to lease a second scanner for two 12 month periods, as well as an option to purchase one or both Xtreme CT II Bone Scanners (Scanco USA, Inc.)

6. Authority Cited: 41 U.S.C. 1901 OR 41 U.S.C. 1903

(a) FAR 13.106-1(b)(1)(i): Only one source reasonable 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: The XtremeCT II (Scanco USA, Inc.) system is a high resolution scanner used to measure bone mineral density of the forearm and lower leg and assess the geometry, strength and microstructure of bone in three dimensions. Capabilities of this system include: 1) Low radiation x-ray scanning (Less than 1/201 the radiation of a single chest x-ray); 2) Distinct separation of compact and spongy bone; 3) Evaluation of trabecular elements-the smallest elements that make bones strong; 4) 3-dimensional analysis of the structure of bone which determines its resistance to fracture; and 5) Built-in finite element analysis which allows for determination of bone's resistance to bending with loading. These capabilities stem from the resolution of the images that are captured with the XtremeCT II (<650µm). No other bone scanners are produced that have these capabilities because this scanner has a resolution that is 6.1 x 10^-6 m and the next best scanner is 1 x 10^-3 m. Scanco is the only company in this market sector with this unique bone scanning capability.

This resolution is critical for assessing very small changes in bone microarchitecture. These small observable changes may have large impacts on the overall health of the bone. In particular, USARIEM aims to address why bones develop stress fracture shortly after beginning physical training and anticipate that this technology brings us closer to understanding why so many recruits are fracturing during initial training. In order to truly understand the effect of initial military training on young adults, USAMRIEM needs an Xtreme CT II scanner that can be taken into the field. While lab studies help to control environments to create stable study designs, the military training environment is unlike a lab, and USARIEM must bring the scanner to the field to be able to study this common musculoskeletal injury. The Xtreme CT II system is necessary to continue USARIEM’s work in the field of stress fracture research. The XTreme CT II system is the only system with the capabilities necessary to assess bone microarchitecture in vivo. Acquiring this system will help provide information on bone health in Military Service Members, with an emphasis on stress fracture research aimed at prevention during the initial weeks of military training when stress fracture prevalence is highest.

8. Efforts to Obtain Competition: USARIEM will analyze the market place at the end of the first 12 month lease period to verify if existing scanners can meet the requirements.

a. Effective competition. Scanco is the only vendor which manufacturer’s a scanner that can meet the current USARIEM requirements.

b. Subcontracting competition. N/A

9. Actions to remove or overcome barriers Competition: Scanco is the only current source. A Request for Information (RFI) was posted from 23 February 2017 – 01 March 2017 with no responses received. When the current equipment is at the end of the lease period, USARIEM will determine if acceptable substitutes exist.

10. Market Survey: Market research was conducted via Internet searches and phone and in-person communications to attempt to identify if other manufacturers of scanners can meet the existing requirements. Phone and in-person discussions with other bone health researchers from different bone health laboratories were conducted regarding the ability to non-invasively study the micro-architecture and macro-architecture of bone in humans. All six scientists agreed that: 1) High-resolution scanning is necessary to answer our stress fracture-related research questions, 2) the XtremeCT II is the only available high-resolution scanner on the market for such human research, and 3) the XtremeCT II is the only validated technology for our purposes as evidenced by cadaver studies and multiple publications across many populations including children, healthy adults, and the elderly. Further, an internet search for a system that included all minimum essential requirements was performed, and XtremeCT II system was the only system identified to meet these requirements.

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: W81XWH-14-C-0059 – Purchase of one (1) Xtreme CT II Scanner.

Previously competed: Sole Source to Scanco USA J&A Log #: 14-059

Previous authority for less than full and open competition: FAR 6.302-1