P03_ Single Source Justification FULLY_Redacted.pdf

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Single Source Justification for SAP under the SAT

Revision: 01 Effective Date: 11/15/2024 Page 1 of 2 Acquisition ID#: 36C241 25 AP 2135

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: 36C241 25 AP 2135

1. Contracting Activity: Network Contracting Office 1, Regional Procurement Office East on behalf of the Department of Veterans Affairs, VISN 1, Providence VA Medical Center, 830 Chalkstone Avenue, Providence RI 02908 4734. Funding 650 25 2 7929 0111.

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount: The Contracting Activity is looking to acquire (7) Fluency Plus Endovascular Stent Grafts for Providence VA Medical Center’s Interventional Radiology Service. These stents are solely manufactured and distributed by OEM LB Bard Peripheral Vascular, Inc. (Bard), UEI: FKCCNJXL9TM7, a wholly owned subsidiary of Becton, Dickinson, and Company (“BD”) 850 W Rio Salado Parkway Tempe, AZ 85281.

The Fluency Plus is a self expandable, flexible, nitinol stent lined with an ePTFE graft and is indicated to open up a new blockage in a previously placed stent on the venous side of the dialysis access Bard Peripheral Vascular circuit. It is used to open up a new blockage in a previously placed stent on the venous side of the dialysis access circuit. Estimated Total Value

(2) Fluency STENTS FEM07040 at

(1) Fluency STENTS FEM08040 at

(1) Fluency STENTS FEM09040 at

(2) Fluency STENTS FEM10040 at

(1) Fluency STENTS FEM12040 at

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: Fluency stents have been shown to be superior to bare metal stents (longer primary and secondary patency rates) for the treatment of stenosis in dialysis fistulas and grafts in randomized controlled, trials. Fluency stents are specifically FDA approved for the treatment of dialysis fistulas and grafts. These stents are provided in small incremental stent graft lengths to help maintain venous real estate and cannulation area; with minimal shortening and radiopaque markers aid in placement accuracy. Ethan Prince, MD a board certified Vascular Interventional Radiologist at Providence VAMC specifically requests this product. Dr. Prince’s recommendation is based on several years of use and direct observation of positive patient outcomes. He states no other stent brand or model will be acceptable. The stents being requested will help the radiologists at Providence VAMC provide the highest level of patient care and safety. No other stents will be technically acceptable. Radiology is expanding it Interventional Radiology Service and will provide A V Fistula maintenance and repairs requiring the use of these stents. The stents have been purchased for Providence VAMC several times in the past through VA purchase card orders under the prosthetics program for individual patients, however this is the first time Providence VAMC will purchase this equipment for forthcoming procedures. As soon as Providence VA Medical Center’s Interventional Radiology Service receives these stents, they can then redirect Veterans care to VA Providence and away from Community Care. The Bard Fluency Plus endovascular stent graft is the

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Single Source Justification for SAP under the SAT

Revision: 01 Effective Date: 11/15/2024 Page 2 of 2 Acquisition ID#: 36C241 25 AP 2135 only FDA approved stent graft to treat in stent restenotic lesions in the central (subclavian and brachiocephalic) and peripheral veins in patients dialyzing with AV grafts or AV fistulae.

4. Description of market research conducted and results or statement why it was not conducted: The Contracting Activity queried various Government wide database of contracts and commercial databases which included VetCert, SBA DSBS, GSA e Library and FPDS. The first search was on VetCert using NAICS 339113, which generated 935 total results. SBA DSBS search using NAICS 339113 along with keyword “Becton Dickinson” produced 0 profiles. GSA e Library search under Becton Dickinson returned one schedule contractor, the OEM Becton Dickinson and Company under contract no. 36F79719D0251, however these stents will be purchased through their subsidiary company, Bard Peripheral Vascular, Inc. through an open market acquisition. Last search was on FPDS using keyword “Fluency Stent” under Department of Veteran Affairs yielded 101 contract actions, all of which were all similar purchases of stents to the VA through LB OEM Bard Peripheral Vascular, Inc. In April 2017, C. R. Bard announced that it would be acquired by Becton, Dickinson, and Company. The transaction was completed later that year, and the company became a wholly owned subsidiary of BD, rebranded as Bard. All market research leads to OEM LB Bard Peripheral Vascular being the only vendor able to provide these fluency stents.

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.

Phillip Crockett Date Contracting Officer

NCO 1/ RPO EAST

PHILLIP

CROCKETT

Digitally signed by

PHILLIP CROCKETT

Date: 2025.02.12 08:45:18 -05'00'