LSJ 25-4048 Shockwave Therapy_Redacted.pdf

SOLE or LIMITED SOURCES JUSTIFICATION Determination Memorandum for Acquisitions Over $3,500 but not Exceeding the SAT

All solicitations and orders shall be competed unless a justification to limit competition using an exception in FAR Part 8, 13, or 16, as applicable to the acquisition, is approved by the Contracting Officer. When the customer describes an item or service, which limits the availability to one source or a particular brand name, there must be a technical explanation describing why only that specific one will meet the government’s requirement. Statements must be detailed and identify the harm that would come to the government (e.g. lack of capability or safety impact). The customer MUST COMPLETE all questions below, as applicable.

PURCHASE REQUEST OR REQUISITION NUMBER ESTIMATED AMOUNT

1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES AND THE INTENDED USE.

2. THE CIRCUMSTANCE THAT REQUIRED LIMITING SOURCES TO A SINGLE MANUFACTURER OR SERVICE PROVIDER. (See FAR 8.405- 6(a)(1)(i) and (b)(1) for exceptions that apply to orders under GSA schedules. See FAR 13.106-1(b)(1)(i) for open market purchase exceptions. See FAR 16.505(b)(2)(i) for exceptions that apply to orders against multiple award contracts.)

3. THE RATIONALE THAT SUPPORTS THE EXCEPTION NOTED ABOVE. (e.g., compatibility with existing equipment, specific performance criteria, proprietary data, only one capable, urgency, logical follow on, satisfy minimum guarantee, etc.).

4. IF APPLICABLE, WHY IS THE PROCUREMENT SO URGENT THAT TIME WILL NOT TO ALLOW FOR ADVERTISING?

5. STATEMENT OF ACTIONS, IF ANY, THE GOVERNMENT MAY TAKE TO REMOVE OR OVERCOME ANY BARRIERS TO COMPETITION.

SIGNATURE CODE TELEPHONE NUMBER DATE

CUSTOMER

CONTRACTING OFFICER

This form may be used in lieu of the determination described in FAR 8.405-6(a)(1)(i), 8.405- 6(b)(2), 13.106-1(b)(1), or 16.505(a)(4).

Customer Approval Levels Ech II ACOS/SA or Deputy Ech III Department Head or Above Ech IV CO, XO, or CMC

N68869534421

NSWCEN N10 requires a Shockwave Therapy unit that is able to deliver Radial Shockwave and Focused Shockwave, which have different clinical applications. The intended us is to treat various musculoskeletal conditions ranging from tendon, ligament, muscular and bony pathology.

FAR 13.106-1(b)(1)(i) only one source reasonably available (BRAND NAME).

Storz DuoLith Ultra (BRAND NAME) device is the only known product that offers radial and focused shockwave therapy in one combined unit.

There are other units on the market, but they are only capable of one of the two modalities. The combined modalities in one unit reduces the footprint which is needed due to limited clinic space.

N/A

The Government will continue to monitor the marketplace for changes to technology that would remove any barriers to future competition.

12 May 2005

12 May 2005