Description
DEPARTMENT OF VETERANS AFFAIRS JUSTIFICATION AND APPROVAL FOR OTHER THAN FULL AND OPEN COMPETITION 1. Contracting Activity: Department of Veterans Affairs, NCO 21; 2615 E. Clinton Avenue, Fresno, CA 93703. 2. Nature and/or Description of the Action Being Processed: Justification and approval for Other than Full and Open Competition for St Jude's Medical USD to provide software upgrade for Ensite System for the San Francisco VA Medical Center. This request will result in the issuance of a new Firm Fixed Price Contract. Brand name item is Cardiac Mapping System Software v 3.0 compatible with GE Combo Lab, EPT Boston Scientific RF ablation system, Biosense Webster stockert RF ablarion system, and carrot medical monitors. 3. Description of Supplies/Services Required to Meet the Agency's Needs: The VA San Francisco Medical Center has a requirement for contractor to provide EnSite Velocity Cardiac Mapping System Software Upgrades. The total amount of this service is not to exceed $37,000. 4. Statutory Authority Permitting Other than Full and Open Competition: FAR 6.302-1(a)(2). The VA's minimum needs can only be satisfied by unique supplies or services available from only one source (41 USC 253 (c) (1)). 5. Demonstration that the Contractor's Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): The Velocity software and EnSite Electrophysiology Workstation are part of the FDA regulated, proprietary EnSite Velocity Cardiac Mapping System only provided by St. Jude Medical. Any unauthorized maintenance or modification to the system would have to be at our own risk, without any sanction from St. Jude Medical; therefore placing all liability on the VA. St. Jude Medical also stated: As a regulated device, we can only sanction repair of the DWS computer via complete replacement. St Jude Medical is the only authorized provider of software upgrades for Ensite System for the San Francisco VA Medical Center. This request will result in the issuance of a new Firm Fixed Price Contract. Brand name item is Cardiac Mapping System Software v 3.0 compatible with GE Combo Lab, EPT Boston Scientific RF ablation system, Biosense Webster stockert RF ablarion system, and carrot medical monitors. 6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: St. Jude Medical is the only vendor authorized and capable of meeting requirement of providing software upgrades for Ensite System for the San Francisco VA Medical Center. This request will result in the issuance of a new Firm Fixed Price Contract. Brand name item is Cardiac Mapping System Software v 3.0 compatible with GE Combo Lab, EPT Boston Scientific RF ablation system, Biosense Webster stockert RF ablarion system, and carrot medical monitors. There is no competition for this repair and must be facilitated by St. Jude Medical. 7. Determination by the Contracting Officer that the Anticipated Cost to the Government will be Fair and Reasonable: Contracting Officer requested recent historical pricing for similar supplies and services performed for other hospitals and VA's. Based on the pricing information provided, $37,000 for software upgrade is fair and reasonable to the Government. 8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Contracting Officer requested additional Sole Source Justification information certified by vendor. This information is included in contract file. St. Jude Medical is the only vendor that can meet requirements for software upgrades. As stated, the software is regulated and proprietary and cannot be redistributed legally by any other vendor. There is no competition for this repair and must be facilitated by St. Jude Medical. 9. Any Other Facts Supporting the Use of Other than Full and Open Competition: No other factors apply, see stated circumstances in para 5 and 6. 10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: None 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: None 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. 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. 09/18/2013 ___________________________ ________________________ Rusty Stevenson Date Contracting Officer NCO 21 b. NCM Designee: I certify the justification meets requirements for other than full and open competition. _____________________________ ________________________ Mark Mikus Date Supervisor, Services Team Contracting Officer NCO 21