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DEPARTMENT OF VETERANS AFFAIRS Justification and Approval Under Simplified Acquisition Procedures (SAP) For Restricting Competition under FAR 13.106-1(b)(1) "Single Source" 1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office (NCO) 20, for Portland VA Medical Center. 2. Nature and/or Description of the Action Being Processed: This is a request for a single source award to PR # 648-12-3-069-0960 in accordance with FAR 6.001(a), acquisitions conducted under FAR 13 for SAP are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2, IAW the VHA SOP for Other Than Full And Open Competition dated 3-22-2012. Urgent and compelling need for Gamunex due to several patients in current therapy requiring the drug within 24 hours in order to continue therapy. The contract allotment of Gamunex was unavailable as of 7:30am, P.S.T., 1 March 2012 due to the allocation being used up before the facility could place their order. 3. Description of Supplies or Services Required to Meet the Agency's Need s : Portland VAMC requires IVIG solution that is sugar free. Several patients are currently in therapy and Pharmacy does not have enough stock to cover all orders after 3/05/12. PO 648-A20126, for $71, 500.00. Line item 1: Gamunex- C 10%, 10GM, XX Vials @ $XXX/g = $42,200.00 Line Item 2: Gamunex C 10% 5ML, XX Vials @ $XXX/g = $7,700.00 Line Item 3: Albumin 25% Solution 100ML @ $XXX/g = $17.600.00 4. Statutory Authority Permitting Restriction in Competition: The statutory authority for restricting competition under SAP, or Single Sourcing, for acquisitions under $150,000 or Simplified Acquisition Threshold (SAT) is 41 U.S.C. 253(c), as implemented by FAR 13.106-1(b)(1). The specific reason for restricting competition is that there is an emergent need with no time for bid. This product is available as a contract item; however, since NAC has not been able to increase contract supply allocations as yet, a non-contract source had to be acceptable. 5. Demonstration that the Contractor's Unique Qualifications o r Nature of the Acquisition Requires the use of the Authority Cited Above (applicability of authority): The Congaree Group has an established distribution network for pharmaceuticals and has the ability to get us this product by the time required. Several patients are in current therapy cycles, so delivery time is critical. They are certified as a SDVOSB in VETBIZ.gov . Gamunex-C is the only IVIG product that is sugar free and has to be used to avoid insulin complications in the recipients. 6. Description of Efforts Made to Ensure that Offers are Solicited from As Many Potential Sources as Deemed Practicable IAW FAR 13.104: In accordance with the orders of priority, contracted product was attempted to be purchased but I was told by the pharmacy prime vendor contractor that no more contract product was available for purchase. With two small businesses found that are able to provide the product and meet delivery times this procurement was set-aside for small businesses. This is a new process and we are diligently researching additional vendors that can supply this product but due to the emergent need, this order had to be placed today in order to receive product by treatment time. In the past, other vendors that can supply this product have denied sales to the Portland PVAMC due to no record of purchase history on an allocated product. 7. Determination by the Contracting Officer that the Anticipated Cost to the Government will be Fair and Reasonable - IAW FAR 13.106-3: The price provided by BDI is competitive with McKesson. In accordance with FAR 13.106-3 (1) Oral quotes were received by vendors. Due to the urgent need award was made to the lowest price. 8. Description of the Market Research Conducted and the Results, or Statement of Reasons Market Research was not Conducted (FAR 10): See market research document in file. 9. Any Other Facts Supporting the Restriction of Competition: Oregon Pedigree Law prohibits the sale of any pharmaceutical drug from another state into Oregon if the product cannot be tracked to origin. 10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: N/A 11. Statement of 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: BDI is a less expensive supplier of Gamunex-C today. Pricing of blood products vary according to market fluctuations. Requirements Certification - IAW FAR 6.303-2(c): I certify that the requirement outlined in this justification is a bonafide 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. _____________________________ ________________________ Name: Lisa Anderson Date Position: Inventory Management Specialist 12. Approvals IAW VHA SOP 3.22.11: Contracting Specialist's Certification: (required) I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. _____________________________ ________________________ Name: Traci Montero Date Contracting Specialist Acquisition Manager's Review and Approval: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and recommend approval for other than full and open competition. ______________________ ________________________ Stacia Nunn Date NCO 20, Supply Acquisitions Team Manager