65--NXStage System One

DEPARTMENT OF VETERANS AFFAIRS Justification and Approval For Other Than Full and Open Competition 1. Contracting Organization: Department of Veterans Affairs, VISN 20, VAPSHCS. 2. Description of Action: This is a request for other than full and open competition for the procurement of The NxStage Dialysis Machine, consumables, and customer support for Continuous Renal Replacement Therapy (CRRT). 3. Description of Supplies or Services: NAXSTAGE SYSTEM ONE NXSTAGE SYSTEM ONE AGREEMENT NUMBER 2010-A-514 FW-200 FLUID WARMER FOR NXSTAGE SYSTEM ONE PUREFLOW SOLUTION NXSTAGE PUREFLOW SOLUTION (LACTATE) PUREFLOW B SOLUTION NXSTAGE PUREFLOW B SOLUTION (BICARBONATE) 4. Statutory Authority: ( x) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements; ( ) (2) Unusual and Compelling Urgency; ( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability, or Expert Services; ( ) (4) International Agreement ( ) (5) Authorized or Required by Statute; ( ) (6) National Security; or ( ) (7) Public Interest 5. Validity of Use of Statutory Authority: Instead of the traditional 3-4 hour hemodialysis session, CRRT is a continuous therapy which ideally provides treatment 24 hours a day. The NxStage system is the newest generation of machines which is user friendly and the ICU nursing staff will be able to easily learn the system and adopt this therapy in all the critical care units. This project will affect the renal dialysis unit and the critical care units. The RDU staff would provide backup and the critical care nursing staff would be the primary user of the machines. A committee including nephrologists, other invited physicians, and nursing staff from the medical and surgical critical care units were involved in the product demonstrations and selection. After reviewing the products and contacting other facilities, the committee selected the NxStage system due to ease of use, less labor intensive and positive reviews from other programs as compared to the other product competitor. We project that one unit would be required for each of the critical care units. 6. Actions to Promote Competition: The VA Renal Dialysis Unit would be willing to re-evaluate when the ease of use, less labor intensive technology is available from other manufactures. At this time Manufacturers only have modified conventional hemodialysis machines which require intense training and monitoring. 7. Determination of Fair and Reasonable Price: In accordance with FAR 13.106-3(a)(2), price has been determined fair and reasonable with comparison of the proposed price with pricing found reasonable on previous purchases. 8. Market Survey (FAR 7.102): The most recent purchase of dialysis machines was made in 2008 and the approximate cost of the equipment is $20,000. At this time, there are no other vendors that manufacture or sell a self contained, simple to use CRRT Dialysis Machine. 9. Other Considerations: This is specialized equipment for a new renal replacement therapy program proposed for the VA critical care units. This machine allows slow continuous renal replacement therapy (CRRT) which is an ideal therapy for critically ill patients with acute hemodynamic instability. Traditional hemodialysis is sometimes not possible in critically ill patients with acute renal failure. CRRT is ideal for patients with hemodynamic instability, post surgical patients with volume overload, liver failure patients, extremely catabolic patients, and patients with CHF and oliguria.