P03 IVL Generator and Connector Cable Kit_Redacted.pdf
PDF 276 KB Posted
- Attached to
- IVL Generator and Connector Cable
- Solicitation number
- 36C26124Q0710
About this file
This document is a Justification for Single Source Awards under the Simplified Acquisition Procedures (SAP) for a requirement by the Department of Veterans Affairs (VA), VISN 21, Reno VA Medical Center. The VA Reno requires an IVL Generator and Connector Cable Kit from Shockwave Medical, Inc., the original equipment manufacturer (OEM) and sole authorized distributor of this novel medical device used to treat patients with calcified coronary arteries. The estimated value of the requirement is not provided. Market research was conducted, including searches on VetCert, SAM, NAC, and GSA, which identified Shockwave Medical as the sole source. The contracting officer has certified the justification for sole source procurement under FAR 13.106-1(b).
The related federal contract opportunity is a Special Notice for the VA's intent to sole source the procurement of the IVL Generator and Connector Cable Kit to Shockwave Medical, Inc. under the authority of FAR 13.106-1(b) and 41 USC 1901. The applicable NAICS code is 339112 with a size standard of 1,000 employees. Interested parties may respond with statements of capability, GSA schedule information, and socioeconomic status by June 20, 2024, but this is not a request for competitive quotes. The government will determine whether to proceed with the sole source acquisition based on any responses received.
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Text version
VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source 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:
RPO West Tracking Number:
1. Contracting Activity: Department of Veterans Affairs, VISN 21, Reno VA Medical Center
2237:
2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount:
The VA of Reno requires an IVL Generator and Connector Cable Kit. Estimated at
3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used:
Shockwave Medical, Inc. is the OEM and only authorized distributor of the IVL Generator and Connector Cable Kit. VA Reno requires this product to treat patients with calcified coronary arteries.
4. Description of market research conducted and results or statement why it was not conducted:
Market research using VetCert, SAM, NAC, GSA, and an email to Shockwave Medical, Inc. A search on VetCert was conducted using NAICS 339112, which resulted in the identification of 659 SDVOSBs/VOSBs operating in that NAICS. A search on SAM identified OEM Shockwave Medical, Inc.
as a large business under NAICS 339112. A search on NAC indicated no current and applicable contract for the required product. A search on GSA Advantage indicated no products that matched the requirement. An email to Shockwave Medical confirmed that there are no authorized distributors. Shockwave intravascular lithotripsy is a novel technological device that treats patients with calcified coronary arteries. VA Reno requires the IVL Generator and Connector Cable Kit to effectively care and treat patients who have calcific coronary artery disease. Therefore, it is recommended that this requirement be sole sourced to Shockwave Medical, Inc. on the open market.
5. 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.
Date
5/28/2024
File details come from the government source that posted it. Updated .