Description
Justification for Other Than Full and Open CompetitionPer the requirements set forth in the Federal Acquisition Regulation (FAR), Parts 6.302, 6.303, and 6.304 the following justification and approval is made regarding the procurement of: Synthes - Small Fragment Locking Compression Plate (LCP) Instrument, Implant Set Ref# 105.34 for the VA Puget Sound Healthcare System.This is a sole source procurement and competitive procedures will not be used. The format for this justification is from the FAR part 6.303-2 and presented in the format prescribed.1. Identification of the agency and the contracting activity, and specific identification of thedocument as a "justification for other than full and open competition."Agency:Contracting Activity: U.S. Department of Veterans Affairs Contracting OfficerVA Puget Sound Healthcare System 9600 Veterans DriveTacoma, WA 98493 2. Nature and/or description of the action being approved. This justification and approval is for a Synthes - Small Fragment Locking Compression Plate (LCP) instrument/Implant Set Ref# 105.34.3. A description of the supplies or services required to meet the agency's needs (including the estimated value. The Department of Veterans Affairs, VA Medical Center, Tacoma, WA intends to negotiate a commercial (FAR Part 12) Sole Source contract under the authority of FAR 6.302-1. The instrument set is a proprietary item and standardizes to the existing instrument sets. Substituting another product would entail completely retooling surgical packs and extensive retraining of both Sterile Processing and Nursing staff. Standardization of these instrument sets represents best practice, standard of care, and is a patient safety issue. The estimated cost is: $42,305.75.4. An identification of the statutory authority permitting other than full and open competition. The statutory authority allowing use of other than full and open competition for this requirement is 41 U.S.C. 253 (c) (1), Only one responsible source and no other supplies or services will satisfy agency requirement.5. A demonstration that the proposed contractor's unique qualifications or nature of the acquisition requires use of the authority cited. The proposed contractor - Synthes USA Sales is the only source capable of meeting the requirement for Surgical & Perioperative Care - Sterile Processing.6. A description of efforts made to ensure that offers are solicited from as many potential sources as is practicable, including whether a CBD notice was or will be publicized as required by Subpart 5.2 and if not, which exception under 5.202 applies. Notice of intent to award as Sole Source was posted on FedBizOpps.gov March 19, 2009 through March 30, 2009.7. A determination by the contracting officer that the anticipated cost to the Government will be fair and reasonable. The quote received from Synthes USA Sales included their published prices. Based on the price and market analysis the cost is determined fair and reasonable in accordance with FAR part 8.404(a)(b).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. Sole source justification as Synthes is found to be the sole manufacturer and distributor for the Synthes - Small Fragment Locking Compression Plate (LC P) Instrument/Implant Set Ref# 105.34.9. Any other facts support the use of other than full and open competition Quantitative/Qualitative). N/A10. A listing of the sources, if any, that expressed, in writing, an interest in the acquisition. None11. A statement of 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. At the end of life-cycle for the existing standardized sets and prior to purchasing new standardized ones, market research will be conducted to determine if new manufacturers and distributors have emerged. 12. Contracting officer certification that the justification is accurate and complete to the best of the contracting officer's knowledge and belief. I certify that this justification is accurate and complete to the best of my knowledge and belief, and that this procurement action is made in good faith with regard for the public interest. //Signed Original Craig S. Magee Contracting Specialist //Signed Original William W. Thompson Contracting Officer