P03 Attachment 1 Single Source Justification 36C259-24-AP-3131 Contract Opportunities.pdf

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: 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: 36C259-24-AP-3131

PR IFCAP: 554-24-3-052-2073

RPOW JOFOC Tracker # FY24 - NCO 19 - 1658

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office (NCO19), VISN 19, 6162 S Willow Drive, Suite 300, Greenwood Village, CO 80111.

Organizational Activity: VA Eastern Colorado Health Care System, Rocky Mountain Regional VA

Medical Center (RMRVAMC) located at 1700 N. Wheeling Street, Aurora, CO 80045.

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount: The

Rocky Mountain Regional VA Medical requires a brand name, firm fixed price contract to acquire Penumbra catheters and accessories for surgical cases performed. These are utilized for embolism cases at the Cath Lab at RMRVAMC. The Penumbra catheters and accessories have acclelerated clot detection and removal for improved patient putcome and recovery.

RMRVAMC needs the following Penumbra products: 1 ea. Penumbra Lighting Flash Procedure pack P/N USVS-LITNGFHTT100BERPPS, 1 ea. Penumbra Flash Aspiration Catheter P/N USVS- LITNGFHT115BEER, 1 ea. Penumbra Throkbectomy system P/N USVS-LITNG12HHTORQ100, and 1

ea. Penumbra Thrombus removal catherer P/N USVS-LITNG12HTORQ1115.

The estimated value of the proposed action is $ 39,004.16

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: IAW 13.106-1(b)(1)(i) Brand Name- The requirement is for surgical cases performed at RMRVAMC. These are utilized for embolism cases at the Cath Lab at RMRVAMC. “The Penumbra catheters and accessories have accelerated clot detection and removal for improved patient outcome and recovery. They have quicker clot detection and patent flow detection. The dual algorithm detects pressure and flow which aids in fast clot removal with minimal blood loss. This is compared to manual aspiration catheters that do not have the ability to detect the difference in clot versus open vessel. The Flash system is 8.4x more powerful and 3.2x softer than Inari FlowTriever 24 and has a safe low profile at 16 Fr versus 24 Fr (French). Also the other manual aspiration systems require the system to be removed from the body and flushed before continuing with the procedure.

Penumbra is designed for more efficient clot removal to speed up case times, which means less time the patient is on the table, less radiation, and less contrast used. They have the most advanced thrombectomy algorithm designed for expedited VTE (Venous Thromboembolism) clot removal.

Penumbra has proven results from the Strike-PE (Pulmonary Embolism) trial which showed average device time during procedures was 24.5 minutes versus in Inari’s own study their average device time was 43 minutes. Penumbra had far fewer complications in their study with only 2.4% MAE https://www.acquisition.gov/?q=/browse/far/13

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT

Last Updated: 02/01/22 Page 2 of 2

(Major Adverse Effects) compared to Inari’s FLAME trial showing 22.6% MAE, as well as Boston Scientific EKOS (Ekosonic Endovascular System) with 10% MAE. Penumbra system is diverse and can be used to treat various sights, such as for DVT (Deep Vein Thrombosis) upper and lower extremity, PE, IVC (Interior Venacava), Iliac, Femoral, and Popliteal; whereas Inari has a catheter for PE and a completely different system for DVT requiring higher amounts of stock. Additionally, the Bolt 7 (penumbra catheter) treats various arteries: subclavian, axillary, brachial, visceral, lower arm, iliac, SFA, Popliteal, Tibials, and Peroneal – in-stent restenosis, bypass graft, hibernating thrombus, and portal vein thrombus.

4. Description of market research conducted and results or statement why it was not conducted:

Market research determined Penumbra is the the Original Equipment Manufacturer (OEM), and a large business. Further Market Research indicated these items are available under federal supply schedule 36F79722D0041 through USVETSERV LLC, SDVOSB. The Nonmanufacturer rule cannot be met for a sole source award to exclusive distributor SDVOSB USVetServ; therefore, this requirement must be solicited unrestricted, brand name competition IAW 13.106-1(b)(1)(i).

5. Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge.

James Lewis Date Acquisition Utilization Specialist Rocky Mountain Regional VAMC

6. 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 808.405-6 Limiting Sources Attachment 1: Justification for Limiting Sources for Micro-Purchase Threshold up to the SAT

Lindsey Zwaagstra Date Contracting Officer Supply 1 Regional Procurement Office West Network Contracting Office 19 https://acquisition.gov/far/current/html/Subpart%2013_1.html#wp1125466