JUSTIFICATION AND APPROVAL FOR OTHER THAN FULL AND OPEN COMPETITION Control Number: 14-290 1. Contracting Activity: The Contracting Activity responsible for this action is the U.S. Army

Medical Research Acquisition Activity, Fort Detrick, MD, in support of the U.S. Army Medical Materiel Agency.

2. Description of Action: Approval is being requested for a new firm fixed price supply

contract for purchase of: 2EA Electrical Safety Add-on kit (P/N:4562308), 2 EA Defibrillator add-on kit (P/N:4562313), 2EA Infusion Kit (P/N:4562324), 2EA Patient Simulator Kit (P/N:4562336), 2EA Electro surgery Kit (P/N:4562349), 2EA Gas Flow-Pressure Kit (P/N:4562351), 10 days of On-site installation and verification (P/N:3031246) and 1 EA Shipping & Handling (P/N:1270449) from Fluke Biomedical using one year FY14 OMA funding.

3. Description of Supplies/Services: This requirement is for 12 Bench Kit parts and 10 days of

installation & verification by a company representative as described in the above paragraph. The estimated cost of this requirement is $415,691.10.

4. Authority Cited: The statutory authority permitting other than full and open competition is 10

U.S.C. 2304 (C) (1) or 41 U.S.C. 253 (c) (1). The Federal Acquisition (FAR) citation is 6.302-1, Only One Responsible Source and No Other Supplies or Services will Satisfy Agency Requirements.

5. Reason for authority cited: Fluke Biomedical is the only authorized manufacturer of these

specific Test Medical Diagnostic Equipment Components.

The Special Purpose TMDE intended to be calibrated by this Automated Test Equipment (ATE) is manufactured by Fluke. This ATE is specifically made to calibrate these items and allows USAMMA to maintain tractability to National Institute of Science and Technology (NIST). Deviation from the manufacture methodology and devices will put the Agency and ultimately our customers at risk. AR 40-61 lists four circumstances under which Army medical maintenance personnel may modify medical equipment: modification work order, quality assurance alteration, minor alteration, and component modernization. All require manufacturer involvement or consent. Chapter 21 of the United States Code governs the actions of the Food and Drug Administration; Section 807 of that regulation addresses medical devices requiring FDA certification. At issue is paragraph 807.81(3)(i), which addresses modifications to medical devices that affect the devices certification status, requiring what the FDA terms premarket notification. Premarket notification is required for any change or modification in the device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process. USAMMA is the Armys medical manager. USAMMA considers any medical equipment alteration, including the substitution of manufacturer-provided or approved repair parts with other repair parts to be contrary to Army and FDA regulations, endangering the devices FDA

certification, and incurring product liability on behalf of the Army. 6. Efforts to obtain competition: No efforts will be made to secure competition as the

equipment being purchased is unique to Fluke Biomedical who manufactures this part. 7. Actions to increase competition: If another need arises, the USAMMA will conduct market

research and/or analysis to determine if the manufacturer has changed the equipment component list to specify a different replacement part available from other suppliers.

8. Market Research: USAMMA has conducted market research for this product by performing

thorough vendor searches for these products by equipment name and part numbers. No other sources of supply could be identified for the above ATE.

9. Interested Sources: To date, no other sources have written to express an interest. This

justification will be published in accordance with FAR 5.102(a)(6). 10. Other Facts: a. Procurement History

(1) An earlier procurement similar to this was executed under contract W81XWH- 12-C-0264.

(2) This action will be accomplished on a non-competitive basis. (3) Authority being used for less than full and open competition is 10 U.S.C. 2304(c)(1), only one responsible source and no other supplies or services will satisfy agency requirements.

(4) A previous justification was prepared to support an earlier procurement similar

to this.

(5) Previous award is W81XWH-12-C-0264.

(6) No unusual patterns have been found.

(7) A previous justification existed for W81XWH-12-C-0264.

b. Equipment lists, item names and part numbers suitable for full and open competition has been developed for this procurement. This action is not being competed because no sources other than Fluke Biomedical can provide this equipment. c. Not applicable. FAR 6.302-2 is not being cited.

d. Not applicable, there are no anticipated major subcontractors for this procurement.

11. Technical Certification: Include the following statement:

I certify that the supporting data under my cognizance which are included in the justification are accurate and complete to the best of my knowledge and belief.

12. Requirements Certification: Include the following statement: I certify that the following data under my cognizance which are included in the justification are accurate and complete to the best of my knowledge and belief.

13. Fair and Reasonable Cost Determination: Include the following determination: I hereby determine the anticipated cost to the Government for this contract action will be fair and reasonable.

14. Contracting Officer Certification. This certification shall be made by the Contracting Officer from this justification and approval. Include the following statement: I certify that this justification is accurate and complete to the best of my knowledge and belief.

JUSTIFICATION AND APPROVAL FOR OTHER THAN FULL AND OPEN COMPETITIONControl Number: 14-290