DEPARTMENT OF VETERANS AFFAIRS Justification and Approval For Other Than Full and Open Competition 1. Contracting Activity: Department of Veterans Affairs, VISN 12, Milwaukee VA Medical Center Justification for Other than Full and Open Competition 2. Nature and/or Description of the Action Being Processed: The contract will be for a maintenance and support for the Abiomed Impella and iPulse machines currently in used by the Hines VA Medical center.. The Impella system is an intravascular blood pump that supports a patient's circulatory system. The iPulse is a multipurpose mechanical circulatory support system for patients suffering acute cardiac failure. 3. Description of Supplies/Services Required to Meet the Agency's Needs: The contractor shall provide all labor, material, travel, parking fees, management, tools, replacement parts and equipment necessary to complete scheduled preventive maintenance on the Impella and iPulse Machines at the V. A. Medical Center, Hines, Illinois. The maintenance contract is needed to ensure that there is no disruption of service. 4. Statutory Authority Permitting Other than Full and Open Competition: ( 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; 5. Demonstration that the Contractor's Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): a. OnlyOne Responsible Source (FAR 6.302-1) - Abiomed is the OEM of the Impella and iPulse systems and is the only vendor with access to proprietary parts and test equipment to ensure devices are returned to original state to meet manufacturer's specifications. As the company that developed and manufactures the machine they have a unique knowledge of the inner workings of the machine that allows for them to conduct preventative maintenance, repairs and provide technical support as needed 6. Description of Efforts Made to ensure thatoffers are solicited from as many potential sources as deemed practicable: In an effort for maximum competition, a Sources Sought was posted to FBO on March 23 2013 and zero interested vendors responded. 7. Determination by the ContractingOfficer that theAnticipated Cost to theGovernmentwill be Fair and Reasonable: Repairs of this type would be done internally at the GS-11 level. A GS-11 employee makes around $59,000 per year which is about $28.00 per hour. This service agreement for the two Impella systems is only $8,495.00 bi-annually and then $4,500 bi-annually the opposite year. The service agreement for the iPulse system is $6,495.00 annually. In addition, we are implementing a five year option contract which will cut down on administrative costs and keep the overall annual cost down. The original purchase price for the Impella's in 2010 was $50,000 each and the iPulse in 2008 was $95,000. VA Hines has invested a substantial amount of money on this equipment. It would be advantageous to the government to properly procure a regular service and maintenance agreement to preserve the investment we have made. According to the national BERS (Biomedical Engineering Resource Survey) the national average for a annual full-service contract is 8% of the acquisition cost. The original equipment price of $100,000 for both Impella systems and $95,000 for the iPulse, 8% would be $8,000 and $7,600.00 these service agreements are less that 8% of the original purchase prices of the equipment. Past procurement history is consistent with the quoted prices: 695-C30122 for iPulse PM was $6,495.00 for Hines, 695-C20347 for two Impella PM's for Hines was $7,000 in 2011, 695-C10346 (2010) 695-C10964 (2011) for iPulse for Hines was $6,079.00 both calendar years, and 695-C10576 for preventative maintenance for 2 Impellas was $12,646.00 for Jesse Brown VA. 8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Market research was conducted to survey the availability and capability of other vendors. A sources sought notice was posted to FBO with zero responses. GSA Advantage was searched using keywords "impella" and "ipulse" with zero results. Vetbiz was searched using keywords "impella" and "ipulse" and zero SDVOSB or VOSB companies were located. The sane search was conducted on SBA.gov with the same results except Abiomed. Abiomed is a small business. Market research was also conducted to explore costs associated with other systems and to ensure fair and reasonable pricing. 9. Any Other Facts Supporting the Use of Other than Full and Open Competition: None. 10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Abiomed. 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: Market research was conducted as well as a Sources Sought. 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. (This signature is the requestor's supervisor, fund control point official, chief of service, someone with responsibility and accountability) _________________________________ _________________________ NAME DATE _________________________________ _________________________ TITLE FACILITY 13. Approvals in accordance with FAR 6.304 This part is filled out by Contracting Staff as part of the Justification. a. Contracting Officer's Certification: (required) I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. _________________________________ _________________________ NAME DATE _________________________________ _________________________ TITLE FACILITY b. ^NCM/PCM: I certify the justification meets requirements for other than full and open competition. _________________________________ _________________________
