Single Source Justification MPT to SAT_Mechanical Thrombectomy System_DCVAMC_Redacted.pdf
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- Solicitation number
- 36C24524Q0189
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This single source justification document from the Department of Veterans Affairs seeks to procure a Penumbra Thrombectomy System from Penumbra, Inc on a sole source basis. The Washington DC VA Medical Center requires a new French thrombectomy catheter system to remove blood clots from veins and pulmonary arteries, treating patients with life-threatening or life-altering blood clots. Penumbra, Inc is identified as the only manufacturer in the United States of the proprietary Lightning Flash system and accessories that use computer-aided vacuum aspiration technology. Market research found 655 potential vendors but a sources sought notice garnered no responses. Penumbra, Inc provided the sole quote. Therefore, the justification argues the VA Rule of Two competition requirement cannot be met for this procurement.
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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 2
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:
1. Contracting Activity: Department of Veterans Affairs, VISN 05, 688 Washington D.C VA Medical
Center; Regional Procurement Office East, Network Contracting Office 5. PR# (2237):
2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount:
The Washington DC VA Medical Center is in need of a new Penumbra Thrombectomy System.
French thrombectomy catheter system is used to remove blood clots from the veins and from the pulmonary arteries. It is used to treat patients who have life threatening or life altering blood clots in the veins or the pulmonary arteries by quickly removing the blood clots and restoring or improving blood flow to the lungs or allowing venous blood flow from the legs.
3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: Using the authority found in FAR 6.302-1 (a)(2), Penumbra, Inc provided a sole source letter stating that they’re only manufacturer that manufactures in the United States the Lightning Flash™ system and accessories, which uses computer-aided vacuum technology, Penumbra’s computer-aided vacuum aspiration technology is proprietary in nature.
4. Description of market research conducted and results or statement why it was not conducted:
A search was conducted on 1.2.2024 on veterans.certify.sba.gov using the NAICS code 339112. The search found 655 SDVOSB and VOSB organizations in the results. A sources sought notice (action # 36C24524Q0168) was posted on sam.gov and garnered no responses. Penumbra, Inc provided an informal quote with pricing. They also provided a sole source letter stating that they’re only company that manufactures in the United States the Lightning Flash™ system and accessories, which uses computer-aided vacuum technology, Penumbra’s computer-aided vacuum aspiration technology is proprietary in nature. USVETSERV, LLC, an SDVOSB, offers Penumbra products on their GSA contract 36F79722D0041, which is a part of the FSS Schedule 65 II A | A-11B.
With the following information, the VA Rule of Two cannot be met.
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.
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 2 of 2
Johao O. Stewart Contracting Officer Regional Procurement Office East/Network Contracting Office 5
Johao O. Stewart 3572389
Digitally signed by Johao O. Stewart 3572389 Date: 2024.01.03 15:38:43 -05'00'
File details come from the government source that posted it. Updated .