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ORIGINAL SIGNED DOCUMENT IS IN FILE DEPARTMENT OF VETERANS AFFAIRS FEDERAL SUPPLY SCHEDULE LIMITED SOURCES JUSTIFICATION AND APPROVAL (FAR 8.405-6) DOCUMENTATION TO JUSTIFY RESTRICTING VENDOR CONSIDERATION - GSA BELOW THE SIMPLIFIED ACQUISITION THRESHOLD (100,000.00) IAW FAR 8.405-6(b) DESCRIPTION OF SUPPLIES OR SERVICES AVAILABLE FROM FSS The Surgical Service requests purchase of TEM (Transanal Endoscopic Microscopic) Instrument System listed on FSS contract # V797P-4072B REQUISITION NO. 501-09-4-119-0159 NAME(S) OF PROPOSED FSS SOURCE(S) Richard Wolfe Medical Instruments Corp. COST ESTIMATE $72,273.49 REQUESTING OFFICE CERTIFICATION I certify that the attached justification is accurate, and contains complete data necessary to support the recommendation for a sole source justification and approval. REQUESTING OFFICE REPRESENTATIVE (Type or Print Name & Title)(required for actions over micro purchase threshold) (Signature) (Phone No.) (Date) SMALL BUSINESS CERTIFICATION I have conducted a search of vendor files from GSA Advantage/Schedules e-Library, etc., to locate potential FSS small businesses for this procurement. If any were found, a list is attached. SMALL BUSINESS SPECIALIST (Type or Print Name (required for actions over $25,000)) Patti J. Amidon (Signature) (Phone No.) 505-256-2833 (Date) PROCUREMENT OFFICE CERTIFICATION I certify that this submission is accurate, and that it contains complete information necessary to enable Approving Officials to make an informed recommendation for approval or disapproval. CONTRACT SPECIALIST (Type or Print Name) (Signature) (Phone No.) (Date) CONTRACTING OFFICER (Type or Print Name) Patti J. Amidon (Signature) (Phone No.) 505-256-2833 (Date) HEAD OF CONTRACTING ACTIVITY (Type or Print Name) Sabrina J. Somerville (Signature) (Phone No.) 480-325-3120 (Date) FEDERAL ACQUISITION REGULATION 8.405-6 (Place X in appropriate box and complete rest of form) X FAR 8.405-6 (b) (1) Only one source is capable of responding due to the unique or specialized nature of the work. The TEM unit is only produced by Richard Wolfe Medical Instrument Crop. And there are no other sellers that carry this product on the FSS. Additionally, NAC contract with Richard Wolfe, V797P-4072B is a required source. FAR 8.405-6 (b) (2) The new work is a logical follow-on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order must not have been previously issued under sole source or limited source procedures. Explain why the work is a logical follow-on and provide information on the original competition for the first order. X FAR 8.405-6 (a) (2) The item is peculiar to one manufacturer (e.g., a particular brand name, product or feature of a product, peculiar to one manufacturer). A brand name item, whether available on one or more schedule contracts, is an item peculiar to one manufacturer. Brand name specifications shall not be used unless the particular brand name, product, or feature is essential to the Governments requirements and market research indicates other companys similar products, or products lacking the particular feature, do not meet, or cannot be modified to meet, the agencys needs. Richard Wolfe makes a unique unit, it is a specialized product with more capabilities, and other makers of similar smaller units do not have 3D visualization and double goggle vision within the unit that enhances its vision field capability. These attributes alone make it a better choice for its use in the operating room environment. Market research indicate no other manufactures provide these capabilities on any of their units. Additionally, NAC contract with Richard Wolfe, V797P-4072B is a required source. FAR 8.405-6 (b) (3) An urgent and compelling need exists, and following the ordering procedures would result in unacceptable delays. Explain why the agencys need for the supplies or services is of such an unusual and compelling urgency that the government would be seriously injured unless it limited the number or sources. Solicitation from as many potential sources as is practicable under the circumstances is required. JUSTIFICATION A. Demonstration that the proposed FSS contractors unique qualifications or the nature of the acquisition requires use of the authority cited. The TEM unit will ensure continued excellent treatment and support of patients that require excision of microscopic Transanal tissues in this medical facility. Patients can be treated and followed at this facility rather than being transferred to another facility not in our VISN. We can provide patients with less invasive procedure using the most current techniques available for lower rectal tumors. Tumors can be treated quickly with better chances of longer survival. Additionally, the NAC contract with Richard Wolfe Medical Instruments Corp., V797P-4072A is a required source. B. Describe the market research that was conducted and the results of the research (e.g., search on e-library at http://www.gsa.gov/fss; historical ordering information, FedBizOpps synopsis). Synopsis is not required for FSS procurements, but may be used. Also, list any FSS sources that expressed an interest in writing in the order and the results of that interest. This agency has completed market survey using the FSS schedule sources for similar manufactures. The search resulted no positive feedback from two other companies that have the ability to provide equally compatible products, none of which have the 3D visualization and the double goggle/camera capabilities that the Richard Wolfe TEM unit has. C. List the actions the agency will take to promote FSS ordering procedures outlined in far 8.405 on any subsequent acquisitions for similar supplies or services. This is a one-time acquisition, and the TEMs unit is available on the NAC FSS contract V797P-4072B which expires 2013.