Single Source Justification IVL Catheters Shockwave.pdf

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

VHAPM Part 813.106 Page 1 of 2

Original Date: 08/30/17 Revision 02 Eff Date: 03/31/2020

U.S. 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: 36C245-21-AP-1177

1. Contracting Activity:

The U.S. Department of Veterans Affairs (VA), Veterans Health Administration (VHA), Regional Procurement Office East (RPOE), VA Capitol Health Care Network

(VISN 5), Network Contracting Office 5 (NCO 5), Station 581 Hershel “Woody” Williams Veterans Affairs Medical Center (VAMC) is fully responsible for the Justification for Single Source Awards for the Brand Name Only Indefinite Delivery/Indefinite Quantity (ID/IQ) Base Year Plus Four One Year Option Year

Periods for IVL Catheters (Shockwave) under purchase request number 581-21-2- 046-2322.

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

The intent is to put in place a Requirements Indefinite Delivery/Indefinite Quantity (ID/IQ) with a base year plus four one year option periods for the IVL Catheters that are considered Brand Name Only for the Shockwave Generator already purchased. These specific IVL Catheters are the only ones that are compatible with already purchased equipment at the medical facility. The estimated amount is: $220,000.00 for five years.

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used:

These specific IVL catheters are the only ones compatible with the Shockwave generator already purchased and on-site. Shockwave Medical, Inc. is the exclusive developer and marketer of the novel and proprietary IVL catheters and no other source can provide.

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

Market research for this procurement was conducted in accordance with (IAW) Federal Acquisition Regulation (FAR) part 10, which describes the policies and procedures that govern the market research process. FAR part 10 assists requesting stations, program offices, and acquisition professionals in determining the most suitable approach for acquiring, distributing, and supporting supplies and https://www.acquisition.gov/?q=/browse/far/13

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

VHAPM Part 813.106 Page 2 of 2

Original Date: 08/30/17 Revision 02 Eff Date: 03/31/2020 services. FAR part 10 implements the requirements of 41 U.S.C. 3306(a)(1), 41

U.S.C. 3307,10 U.S.C. 2377, and 6 U.S.C. 796.

The Hershel “Woody” Williams VAMC has a need for IVL Catheters. A North American Industry Classification System (NAICS) code search for IVL Catheters

(Shockwave) was utilized and yielded a NAICS code of 339112, which includes corresponding index entries such as Surgical and Medical Instrument Manufacturing with a product service code (PSC) search of 6515, Medical and Surgical Instruments, Equipment, and Supplies. The NAICS code size standard for 339112 is 1,000 employees.

in accordance with far part 10.002 (2), methods used to conduct market research consisted of reviewing the results of recent market research/historical data in IFCAP undertaken to meet similar or identical requirements. The methods were conducted in a manner that sought to determine the best acquisition strategy to acquire the supplies or services requested by the customer and meet the needs of the government in the specific timeframe.

The Contracting Officer reviewed the Vendor Information Pages (VIP) for NAICS code 339112 and found 395 (at the time of the query) Service Disabled Veteran Owned Small Business (SDVOSB) and Veteran Owned Small Business (VOSB) total through the VIP query for market research as required. 342 (SDVOSB) | 53 (VOSB). Unfortunately, the Contracting Officer is not able to apply the “VA Rule of Two” to this procurement since Shockwave Medical, Inc. is the exclusive developer and marketer of the novel and proprietary IVL catheters and has provided proof to that extent.

As described above, market research, in accordance with FAR part 10, was conducted by synopsis of the proposed acquisition and informing industry of the pending acquisition through posting of sources notices and only received one response by the aforementioned sole source interested party.

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.

Contracting Officer’s Representative (COR) Contracting Officer (CO) https://acquisition.gov/far/current/html/Subpart%2013_1.html#wp1125466