6515--SURFACER INSIDE OUT ACCESS CATHETER SYSTEM

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT Last Updated: 02/01/22 Page 1 of 1 DEPARTMENT OF VETERANS AFFAIRS Justification for Single Source Awards IAW FAR 13.106-1 For Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K) Acquisition Plan Action ID:_ VA-23-00096516 Contracting Activity: Washington DC VA Medical Center, 50 Irving St NW 20422. VISN 5 . Brief Description of Supplies/ Services required and the intended use/Estimated Amount: Patients who are on hemodialysis for a long time are at risk of developing blockages in the veins used for dialysis which over time could lead to loss of hemodialysis access. This can ultimately force the patient and the clinician to use dialysis access that is of lower quality and many times can lead to the loss of ability to undergo dialysis all together. For the vast majority of these patients life without dialysis is not sustainable for more than a few days, and for all dialysis patients in general, life expectancy is directly related to the availability of optimal dialysis access. The Surfacer Inside-Out device is the first FDA-approved device to allow the creation of new dialysis access at a site where previously no access would have been possible. By doing so it offers the patients a chance to continue to undergo dialysis through a functional, safe and high quality access site. It will be used in patients requiring hemodialysis who are running out of dialysis access options. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: The Surfacer Inside-Out Access Catheter System is the only FDA-approved device for creating venous access through an occluded central venous system. The current vendor is Meritt Medical and the order number is 600200/A. Currently there are no other FDA-approved devices that perform the same function. The packaging includes: The Surfacer Catheter An 80 cm 10-French sheath A peel away sheath There are no special additional supplies needed other than fairly routine items including 12-French x 45 cm sheath A 260 cm Amplatz wire The quantity to be used is one per case, however would always like to have one as a backup in case of mishandling or malfunction of one device. The device comes in one size and there are no options to choose from. The anticipated volume of cases requiring this device at the Washington DC VA Medical system, under current practice patterns, is estimated to be less than five per year. Description of market research conducted and results or statement why it was not conducted: This is device is only available through one vendor (Merrit Medical) and there are no other devices similar to this device or FDA approved to perform the same or similar function in the market. The device is essential in allowing the operator to create a new venous access option through an occluded vein in the chest thereby offering additional options for hemodialysis through the chest or upper extremities in patients who either have no options for diaysis or whose only option is a groin access which has a much higher incidence of complicaitons and infections. Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. Name Title