Description
Chapter VI: Other Than Full and Open Competition (OFOC) SOP Request for Sole Source Justification Format OFOC SOP Revision 05 Page 3 of 3 Original Date: 03/22/11 Revision 05 Date: 05/02/2016 DEPARTMENT OF VETERANS AFFAIRS Justification and Approval (J&A) For Supplies from Bard Peripheral Vascular Other Than Full and Open Competition Consignment for Bard Medical Stents, IVC Filters, Balloons, and other Bard consumable products for Interventional Radiology Procedures Contracting Activity: Department of Veterans Affairs, Network Contracting Office (NCO) 19 is the responsible contracting agency for the Eastern Colorado Healthcare System s (ECHCS). This is a request for other than full and open competition for Bard Peripheral Vascular vascular and tracheobronchial stents, stent-grafts, and other related products for use in Interventional Radiology (IR) procedures at the Denver VAMC. Nature and/or Description of the Action Being Processed: This proposed contracting request is to obtain Bard Peripheral Vascular and tracheobronchial stents, stent-grafts, and other related products for use in Interventional Radiology (IR) procedures. The total value of this consignment is estimated at REDACTED. This requirement is required as an urgent need so that there is no delay in patient care or delay in scheduling IR procedures. Description of Supplies/Services : The requirement is to provide devices to be used for treating peripheral arterial occlusive and stenotic vascular disease, enabling restoration of normal blood flow and improvement in claudicating symptoms. This is performed in both an emergent and routine service as need, and is often an alternative to bypass surgery. Additionally, these stent and stent-graft products can be utilized in the venous system. The Denver ECHCS has a large hemodialysis population requiring recurrent endovascular intervention. This provides improved flow rates and longer patency in select native fistulas and bypass grafts as opposed to repeat balloon angioplasty. Stent-graft products are essential to our product inventory. These are bare metal stents that are lined with a PTFE covering; effectively an endovascular delivery of a bypass graft. The products are utilized from a patient safety standpoint when vascular rupture occurs in either the arterial or venous system. The stent-graft covers the ruptured segment, allowing normal blood flow to continue. There is evidence showing improved patency and duration when utilizing these stent-grafts in the venous system at sites of recurrent fistulae anastomotic stenosis. Statutory Authority Permitting Other than Full and Open Competition: 41 USC §3304(a)(1), as implemented by FAR 6.302-1 (x) (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 ( ) (5) Authorized or Required by Statute FAR 6.302-5; ( ) (6) National Security per FAR 6.302-6; ( ) (7) Public Interest per FAR 6.302-7; Demonstration that the Contractor s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): The products described in Section III have been determined by IR to be the best products to treat the Veteran s medical condition and functional limitations, and substituting the stent and stent-graft products would be detrimental to the treatment of the Veteran. The LifeStent stent is the first FDA approved bare metal stent for the superficial femoral and proximal popliteal artery, while the LifeStar stent products are used for iliac occlusive arterial disease. These stents are preferred due to its success rates for vessel patency over time, as the competitor stents do not have the same flexibility found in the Bard system and the resistance of the competitor stents can lead to difficult endovascular delivery and stent failure. The Fluency stent is the first and only FBA approved stent to treat venous anastomosis stenosis of ePTFE or other synthetic AV grafts. The Flair stent is a puzzle tantalum marking system that provides superior fluoroscopic visualization during deployment. Bard Peripheral Vascular is the only company that can to provide these items. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Utilizing the authority in 38 U.S.C. 8123 and 41 U.S.C. 253(c)(5), it is appropriate to award this acquisition to Bard Peripheral Vascular without regard to any other provisions of law, to include full and open competition. As required by FAR 5.2, this action will be synopsized through FedBizOps. In addition, this justification will be published with the solicitation in accordance with FAR 6.305(a). Determination by the Contracting Officer that the Anticipated Cost to the Government will be Fair and Reasonable: The price is determined to be fair and reasonable based on comparison with other endovascular stent and stent-graft products. Our anticipation is that when the 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 can lead to product expiration and wasted capital. An affirmation of the existing sole source fixed price is contemplated with Bard Peripheral Vascular, P.O. Box 1740, Tempe, AZ 85280-1740, which is defined in the spreadsheet that is attached with the package. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Market research was performed to explore the differences between the various available stent and stent-graft products. Bard Peripheral Vascular has the first FDA approved femoral and proximal popliteal arterial stent system. The stent design balances the flexibility needed for a mobile body part (i.e.; lower leg) and the radial strength needed to achieve durable arterial patency. This is detailed in the RESILIENT randomized control trial. The competitor stents do not have the same flexibility as the Bard system, which can lead to difficult endovascular delivery and stent failure. The stent-graft product is FDA approved for use in venous anastomotic stenosis in hemodialysis access grafts. Data from Flair and Renova trials show significant improvement in vascular patency as compared to angioplasty alone, and no data were found evaluating competitor stent-grafts in the venous system. The Flair has a flared proximal edge that is designed to mimic the venous system anatomy and diminish turbulent flow. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Bard Peripheral Vascular, Inc., 1625 W 3rd Street, Tempe, AZ 85281 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: Research of other possible vascular and tracheobronchial stents, stent-grafts, and related products were reviewed but no other comparable items were found. 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. REDACTED Approvals in accordance with the VHAPM, Volume 6, Chapter VI: OFOC SOP. Contracting Officer or Designee s Certification: I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. REDACTED Director of Contracting/Designee: I certify the justification meets requirements for other than full and open competition. REDACTED