DEPARTMENT OF VETERANS AFFAIRS Justification and Approval For Other Than Full and Open Competition St Jude Heart Valve Consignment Agreement 1. Contracting Activity: The contracting activity responsible for this acquisition is Network Contracting Office (NCO) 19 on behalf of the Department of Veterans Affairs, VISN 19, VA Salt Lake City Health Care System (VASLCHCS) located at 500 Foothill Drive, Salt Lake City, Utah, 84148 and the Eastern Colorado Health Care System (VAECHCS) located at 1055 Clermont St, Denver CO 80220. 2. Nature and/or Description of the Action Being Approved: This proposed contracting action is for a consignment agreement with St Jude for their Trifecta heart valves. The term for this acquisition is one base year plus four option years. The consignment source is St. Jude: 1 Lillehei Plaza, St Paul, MN 55117-9983. 3. Description of Supplies/Services Required to Meet the Agency's Needs: St Jude will provide varying sizes of Trifecta heart valves for patients of the George E. Wahlen VA Salt Lake City Health Care System and the Eastern Colorado Health Care System on a consignment basis. These heart valves will be used in aortic valve surgeries. The anticipated term of this consignment agreement will be for one base year and four option years beginning on or around January 1, 2015. It is estimated that the VA should have two of each size heart valve available to ensure optimal patient care. The cost for the duration of this agreement is estimated at $650,000.00 for five years. The medical center included a 3% increase in each years estimate. 4. Statutory Authority Permitting Other than Full and Open Competition: ( ) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per FAR 6.302-1; ( ) (2) Unusual and Compelling Urgency per FAR 6.302-2; ( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per FAR 6.302-3; ( ) (4) International Agreement per FAR 6.302-4 (X) (5) Authorized or Required by Statute FAR 6.302-5; see also 38 U.S.C. 8123 ( ) (6) National Security per FAR 6.302-6; ( ) (7) Public Interest per FAR 6.302-7; 5. Demonstration that the Contractor's Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): Surgically implanted products are specified by the clinical team to meet the unique and comprehensive needs of each Veteran with an identified medical indication. The specific product described above has been determined by the clinical team to be the best product to treat the Veteran patient's medical condition and functional limitations. Substituting an implant with other than that specifically prescribed is beyond the role, competency and professional functions of the Contract Specialist and would be detrimental to the treatment of the Veteran patient. Full and open competition for the above described implant negates the clinician's subject matter expertise as related to the medical treatment for the individual Veteran as outlined in VAAR 806.302-5. In this case the by-name device(s) is/are the specific prescription and method of treatment for the Veteran-patient. 6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: This product is only available from one source. St Jude is the sole manufacturer and provider of these heart valves. St Jude does not authorize these products to be purchased by any vendors or small business distributors. 7. Determination by the Contracting Officer that the Anticipated Cost to the Government will be Fair and Reasonable: The total value of the current requirement is $650,000.00. The cost is determined to be fair and reasonable based on comparison with other heart valve products. Our anticipation is that when a consignment contract is achieved, use of products will limit costs to only those used and avoid expired product inventory. This is in contrast to maintaining a large inventory of variable sized products, which leads to product expiration and wasted capital. 8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Market research was performed on August 27, 2014 to explore other possible vendors that can provide the Trifecta heart valve products. The required products for this acquisition cannot be purchased through any other source. The detailed Market Research Report is included in the contract file. 9. Any Other Facts Supporting the Use of Other than Full and Open Competition: Based on the medical judgment of the Chiefs of Surgery at the Salt Lake City VA Medical Center and Eastern Colorado Health Care System in Denver, Colorado, an alternative product would not meet all of the intraprocedural requirements to allow a safe and efficient use, nor do several competitive products have FDA approval. 10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: See Section 6 above. 11. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required: The Requesting Service will continue working with the RMAC in conducting Market Research for similar technology for the treatment of aortic diseases. ? 12. Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and 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. _____________________________ ________________________ Taminca Danford-Leaf Date Procurement Specialist Salt Lake City VA Medical Center 13. Approvals in accordance with FAR 6.304 a. Contracting Officer's Certification: (required) I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. _____________________________ __________________ Aaron Jiron Date Contracting Officer Network Contracting Office (NCO) 19 b. Local Quality Assurance: (required) I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. _____________________________ __________________ Angela Rand or Jason Brown Date Quality Assurance Network Contracting Office (NCO) 19 c. Director of Contracting: I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. _____________________________ _______________________ Curtis M. Jordan Date Director of Contracting Network Contracting Office (NCO) 19
