DEPARTMENT OF VETERANS AFFAIRS Justification for Brand Name Awards IAW FAR 13.106-1 For Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K) Acquisition Plan Action ID: Contracting Activity: Department of Veterans Affairs, VISN 10, Network Contracting Office in Kettering, Ohio has been requested by the John D. Dingell VAMC, Detroit, MI to procure LithoClast Trilogy System Kit w/accessories. Brief Description of Supplies/ Services required and the intended use/Estimated Amount: This request is to purchase the following LithoClast Trilogy System Kit which is a dual energy, single-probe lithotripsy and stone removal system. It will fragment and remove stones in the kidney, ureter and bladder during Urology surgery. This is a LithoClast used during PCNL to break stones. Dr. Khurshid Ghani, MD, MS Associate Professor of Urology University of Michigan has conducted trials of this device and it is superior in breaking up hard stones and sucking out the fragments. Estimated Cost: Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: The Trilogy system consists of capital, reusable, single-use and accessory equipment. The capital equipment consists of a console with an LCD touch-screen interface for adjusting settings and a foot switch for activating energy and suction. The reusable handpiece transduces electrical energy into ultrasound and ballistic energy delivered through a single-use probe. Several unique characteristics limit availability to only one source, with the reason no other supplies or services could be used to accomplish the necessary Urology procedure in the operating room. To break up the largest kidney stones, the provider will need to use a minimum endoscope working channel of 12 Fr and a maximum of 330mm. The Urology providers will need to use this type of disposable probe on a recurring basis to break up the largest of stones in the operating room. The Trilogy system uses a single-use probe kit and the associated handpiece kit. The supplies and handpiece cannot be used with any other device and the disposables have been approved for use by the Ann Arbor VHA Clinical Product Review Committee. The 2nd characteristic that limit availability to only one source, is the LithoClast pneumatic function which allows the longest go-ahead time of 138 seconds to remove the stone. This allows very large stones to be removed faster via the ballistic energy to break them up and suck them out. This is not only important to the length of the case and how long the patents remains under the care of Anesthesia, but can become a patient safety issue if a provider is forced to use a device of lower quality which also limits their ability to perform an efficient procedure. This device performs these essential governmental functions and therefore reduces government risk in the process. Description of market research conducted and results or statement why it was not conducted: VIP/VetCert/DSBS all were searched using NAICS Code 339113; VetCert provided 761 vendors that could potentially provide this equipment/supplies. However, using the same NAICS Code and adding the key words trilogy lithotripsy in VIP/DSBS, no SDVOSB/VOSB vendors were identified and able to provide the requested items. However, it was found in the MSPV site that like items are available utilizing the SDVOSB vendor, Veteran s Healthcare Supply Solutions, Inc. (VHSS). Per the OEM, Boston Scientific Corporation, VHSS is the only SDVOSB vendor who has authorized distributor authority to provide these items. The SDVOSB pricing is exactly the same as the OEM, with no additional mark-up for the requested equipment. The VA Rule of Two cannot be met with this procurement. Solicitation should be placed in Contract Opportunities, as an unrestricted RFQ on the open market. This will likely be awarded to the SDVOSB vendor, as the OEM will not provide the disposable products as requested from the service. Additionally, the NAICS Code was not found in the NMR Class Waiver Listing, so this solicitation will be competed Open Market and unrestricted in Contract Opportunities. 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. ____________________________ LouAnn Gilliland Contracting Officer Responses to this solicitation are due on or before Wednesday, March 8, 2023 at 12:00PM. Eastern Time to LouAnn Gilliland, Contracting Officer, via email at
contact@example.gov. No phone calls will be accepted. #1. The following items are being requested for this procurement: DESCRIPTION PRODUCT NUMBER QUANTITY - - Swiss LithoClast Trilogy System Kit M006840200K0 1 3.9MM X 440MM TRILOGY PROBE KIT M0068403550 1 3.9MM X 350MM TRILOGY PROBE KIT M0068403540 1 3.4MM X 445MM TRILOGY PROBE KIT M0068403530 1 3.4MM X 340MM TRILOGY PROBE KIT M0068403520 1 1.9MM X 341MM TRILOGY PROBE KIT M0068403510 1 1.5MM X 440MM TRILOGY PROBE KIT M0068403500 1 1.1MM X 425MM TRILOGY PROBE KIT M0068403470 1 1.1MM X 520MM TRILOGY PROBE KIT M0068403480 1 1.1MM X 625MM TRILOGY PROBE KIT M0068403490 1 STONE CATCHER FOR TRILOGY (BOX OF 5) M0068402981 1 DOUBLE SUCTION BAGS SET (BOX OF 5) M0068402061 1 SUCTION BAG 5L (BOX OF 10) M0068402071 1 SWISS LITHOCLAST TRILOGY HANDPIECE KIT M0068402030 1 TRILOGY REUSABLE TORQUE WRENCH M0068403590 1 TRILOGY STERI-HOLDER M0068401640 1 SWISS LITHOCLAST TRILOGY CART M0068401760 1 #2. Delivery of these items will be to the following location: Department of Veterans Affairs John D. Dingell VAMC 4646 John R. Street Detroit, MI 48201-1916 #3. Delivery will be Destination Only. If additional charges are necessary for shipping/delivery charges, please include this pricing into the cost of the items.
