65--506-18-2-025-1091 Bard Consignment

VHAPM Part 806.3 Other Than Full and Open Competition (OFOC) SOP Attachment 2: Request for Sole Source Justification Format >SAT OFOC SOP Revision 08 Page 1 of 2 Original Date: 03/22/11 Revision 08 Date: 04/18/2018 DEPARTMENT OF VETERANS AFFAIRS Justification and Approval (J&A) For Other Than Full and Open Competition (>SAT) Acquisition Plan Action ID VA250-18-AP-5795 Contracting Activity: Department of Veterans Affairs, NCO 10, VA Ann Arbor Medical Center, purchase request number 506-18-3-025-1790. Nature and/or Description of the Action Being Processed: The VA Ann Arbor Healthcare System requests a consignment agreement for a base year with four, one year option periods, for Lifestream Stents and Lutonix Balloons with Bard Peripheral Vascular, 1625 West Third ST, Tempe, AZ 85280 - Phone: 800-321-4254. The contractor, Bard, will be responsible for maintaining the agreed to inventory levels and will retain ownership of the material until the VA uses an item. At which time, the VA will make payment for the used item. FAR13.5 Simplified Procedures for Certain Commercial Items: This procurement is for stents and balloons in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501 Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2. Description of Supplies/Services Required to Meet the Agency s Needs: This consignment agreement is for the Lifestream family of stents and Lutonix family of balloons. The estimated value for the expected usage is $1,056,000.00. The period of performance will be from the date of award for one year with four one year option periods. 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 ( ) (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; ( X ) FAR13.5 Simplified Procedures for Certain Commercial Items: The authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. 1901 and is implemented by for restricting competition on this procurement via FAR 13.106-1(b)(2). Demonstration that the Contractor s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): Only one responsible source. The LIFESTREAM Covered Stent is a balloon expandable covered stent that is for vascular usage and is designed to provide trackability to reach lesions through complex and tortuous anatomy, providing ease of delivery to the target lesion. The Lutonxi balloons are the only balloons that are drug eluding. The supplies are selected based on their specific use during procedures and often times, supplies from several vendors may be used during one procedure based on what the doctor finds during the procedure. Consignment contracts allow the VA to keep several of these short shelf life items in the facility without having to buy them until they are used. The items requested meet the strict requirements of quality and functionality for which procedures they are chosen for. The VAAAHS maintains several consignment contracts simultaneously but each is put in place as a sole source contract so that the facility can stock that particular vendor s supplies in a variety of sizes and families and have all of them available at a moments notice to VA physicians. This ability is critical to ensure the best outcomes in these life-saving and life extending procedures. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: An Intent to Sole Source was posted to FBO with no responses. The requesting service, Doctors and the vendor have all had discussions and this is the only vendor that is willing to enter into a contract of this nature for these particular products at this time. If it is discovered that there are other sources that will enter into this type of a contract, the facility is willing to try those products or enter into a contract competitively. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The contracting office will determine the prices fair and reasonable prior to contract award. The Contracting Officer is anticipating using comparison of currently proposed prices to prices paid on previous procurements to determine the price is fair and reasonable. Pricing is similar to other commercial stents and balloons on the market. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: GSA and NAC were searched. An intent to sole source was posted to FBO with no responses. Manufacturer was contacted and they have no distributors for consignment agreements for these products. Any Other Facts Supporting the Use of Other than Full and Open Competition: The current stents (ICAST) being used are not indicated for vascular use and it was the only stent available previously. However, now that LIFESTREAM was launched, physicians have a stent that is FDA approved for the correct indication. Additionally, it has a smaller profile which is better for the patient. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: None. 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: Should a requirement of this nature recur, the market will again be surveyed.