65--Synthes E-Pens for Surgical Service

Justification for Other Than Full and Open CompetitionFAR 6.303-2 Content. (a) Each justification shall contain sufficient facts and rationale to justify the use of the specific authority cited. As a minimum, each justification shall include the following information: (1) Identification of the agency and the contracting activity, and specific identification of the document as a "Justification for other than full and open competition." VA North Texas Health Care System, Dallas, TX (2) Nature and/or description of the action being approved. Surgical orthopedic (hand) equipment being purchased. (3) A description of the supplies or services required to meet the agency's needs (including the estimated value). Purchasing of a surgical orthopedic hand equipment system; including saws, drills, irrigation system, pen drive with multiple attachments, hand and foot controllers, connectors, etc to operate on very small areas of the body and under sterile conditions. (4) An identification of the statutory authority permitting other than full and open competition. FAR 6.302-1 Only one responsible source and no other supplies or services will satisfy agency requirements. (5) A demonstration that the proposed contractor's unique qualifications or the nature of the acquisition requires use of the authority cited. The current equipment, which we actually have in the OR now, does not address the small instrument issues needed specifically for orthopedic surgery of the hands. Our experienced surgeons have used several brands of instruments over many years. Synthes provides the saws, drills and necessary attachments that work best in small areas subject to orthopedic surgery such as hands. We went through an approved clinical trial in May 2009, and the Deputy Chief of Staff has agreed that the e-pen system from Synthes was the best option. Orthopedic hand cases have different requirements from those of the hip and knee. There is not one universal saw. These Synthes instruments that will likely be in use for at least one, if not more, will fit the requirements necessary for hand surgery. The "technology" does not get surpassed, and they usually are long lasting, when properly processed and serviced. (6) A description of efforts made to ensure that offers are solicited from as many potential sources as is practicable, including whether a notice was or will be publicized as required by Subpart 5.2 and, if not, which exception under 5.202 applies. One other electric pen drive was evaluated but the saw blades were not small enough for successful hand surgery. A search on GSA Advantage brought up no vendors who sell this E Pen System on a FSS contract. This was announced as a Sole Source on the FBO Website. (7) A determination by the contracting officer that the anticipated cost to the Government will be fair and reasonable. The anticipated cost to the Government is hereby determined fair and reasonable. No one else provides this particular E-pen. (8) A description of the market research conducted (see Part 10) and the results or a statement of the reason market research was not conducted. Market research was conducted in September 2009 via GSA Advantage and no vendors were found who sell this E-Pen System on a FSS Contract. (9) Any other facts supporting the use of other than full and open competition, such as: (i) Explanation of why technical data packages, specifications, engineering descriptions, statements of work, or purchase descriptions suitable for full and open competition have not been developed or are not available. Our experienced surgeons have used several brands of instruments over many years, Synthes provides the saws, drills and necessary attachments that work best in small areas subject to orthopedic surgery such as hands. (ii) When FAR 6.302-1 is cited for follow-on acquisitions as described in FAR 6.302-1(a)(2)(ii), an estimate of the cost to the Government that would be duplicated and how the estimate was derived. No follow on acquisition will be made. (iii) When 6.302-2 is cited, data, estimated cost, or other rationale as to the extent and nature of the harm to the Government. Not Applicable (10) A listing of the sources, if any, which expressed, in writing, an interest in the acquisition. Synthes - we have a quote. (11) A statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the supplies or services required. In the future, full open competition will be sought for this item. At this time, we do not know if a new clinical trial will be preformed to open up the use of other size instruments. (12) Contracting officer certification that the justification is accurate and complete to the best of the contracting officer's knowledge and belief. (b) Each justification shall include evidence that any supporting data that is the responsibility of technical or requirements personnel (e.g., verifying the Government's minimum needs or schedule requirements or other rationale for other than full and open competition) and which form a basis for the justification have been certified as complete and accurate by the technical or requirements personnel.