P03 Single Source Justifiation - BS IVUS - Over SAT - Final Signed - Redacted.pdf

Attachment 1: Request for Sole Source Justification Template >SAT-SAP under RFO FAR 12

Acquisition ID#: 36C242-26-AP-2036

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH RFO FAR 12

Acquisition Plan Action ID: 36C242-26-AP-2036

Contracting Activity: Department of Veterans Affairs, VISN 02, Network Contracting Office (NCO) 2, 3495 Bailey Avenue, Buffalo, NY 14215 in support of NYHHS Manhattan VA Medical Center, 423 E 23

Street, New York, NY 10010 (Biomedical Engineering, Building 1, 14th Floor West).

2237 30-26-3-4456-0118

Nature and/or Description of the Action Being Processed:

This sole source firm fixed price requirement is for the service and maintenance of the Boston Scientific AVVIGO+ Intravascular Ultrasound Systems and MicroPace EP Stimulator systems located at the NYHHS Manhattan VA Medical Center. The proposed purchase order shall be provided to Boston Scientific Corporation, 300 Boston Scientific Way, Marlborough, MA 01752 from 05/28/2026 to 05/27/2027, to include four (4) option years.

Base Year: $80,239.02 Option 1: $106,750.00 Option 2: $106,750.00 Option 3: $102,750.00 Option 4: $48,000.00 The total dollar value of this requirement is $444,489.02.

Description of Supplies/Services Required to Meet the Agency’s Needs:

This requirement is to provide a service contract to conduct the preventative maintenance of CATH and EP Equipment located at the NYHHS Medical Center – Manhattan (423 E 23 Street, New York, NY 10010) and Brooklyn Campus (800 Poly Place, Brooklyn, NY 11209).

Statutory Authority Permitting Restricted Competition:

RFO FAR 12 Acquisition of Commercial Products and Commercial Services. The statutory authority for applying the procedures for Commercial Items of FAR 12 is 41 U.S.C. § 1901 and is implemented by FAR RFO 12.201-1 for restricting competition on this procurement. Competition is restricted on this procurement for the reason below:

Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per 41 U.S.C. § 1901 as implemented by RFO FAR 12.201-1;

( ) Unusual and Compelling Urgency per 41 U.S.C. § 1901 as implemented by RFO FAR 12.201-1;

( ) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per 41 U.S.C. § 1901 as implemented by RFO FAR 12.201-1;

( ) International Agreement per 41 U.S.C. § 1901 as implemented by RFO FAR 12.201-1;

Acquisition ID#: 36C242-26-AP-2036

( ) Authorized or Required by Statute per 41 U.S.C. § 1901 as implemented by RFO FAR 12.201-1;

( ) National Security per 41 U.S.C. § 1901 as implemented by RFO FAR 12.201-1;

( ) Public Interest per 41 U.S.C. § 1901 as implemented by RFO FAR 12.201-1;

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

A proprietary letter was received from Boston Scientific Corporation stating that AVVIGO Guidance Systems are sole source products, manufactured, sold, and distributed exclusively by Boston Scientific and its authorized distributors.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

A Notice of Intent to Sole Source (36C24226Q0445) was posted on SAM.gov from 03/19/2026 to 03/26/2026 and received zero (0) responses.

A proprietary letter was received from Boston Scientific Corporation stating that AVVIGO Guidance Systems are sole source products, manufactured, sold, and distributed exclusively by Boston Scientific and its authorized distributors.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable:

Price reasonableness shall be determined by comparing the price of the quote received from Boston Scientific Corporation for the service and preventative maintenance of Cardiology, Cardiac Catheterization (CATH), and Electrophysiology (EP) systems such as various AVVIGO+ Intravascular (IVUS) systems, MicroPace EP Stimulator Systems, EP LabSystem Pro, and the FARAPULSE Ablation System to the price of Contract 36C25025P0826 for similar services located at the Richard L.

Roudebush VA Medical Center, ending on 04/07/2025, in the amount of $113,685.00. The base year price quoted by Boston Scientific Corporation is $80,239.02, which is $33,446.00 or 29.4% less than the cost of contract 36C25025P0826.

The base year price of this requirement is prorated due to the alignment of end dates to match warranty expirations. To further determine price reasonableness, the cost of contract 36C25025P0826 shall be compared to the quoted price for option year one (1) which is $106,750.00.

The quoted price from Boston Scientific is $6,935.00 or 6.1% less than the cost of contract 36C25025P0826. Therfore, the quoted price shall be determined fair and reasonable.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:

A search of SAM.gov validated that Boston Scientific Corporation has an active registration as a large business under NAICS code 811210.

A general search of GSA eLibrary using keywords “AVVIGO+ Intravascular Ultrasound” and “MicroPace EP Stimulator” that identified zero (0) schedules available. Further search of GSA eLibrary using keywords “Boston Scientific Corporation” identified one (1) available schedule, 36F79722D0198, for pharmaceuticals and drugs (including antiseptic liquid skin cleansing detergents

Acquisition ID#: 36C242-26-AP-2036 and soaps, dispensers, and accessories). Upon further review of this schedule, it was determined that it does not meet the needs of this requirement.

A general search of SBA Small Business Search Engine was conducted using NAICS code 811210 and keywords “AVVIGO+ Intravascular Ultrasound” and “MicroPace EP Stimulator” which identified zero

(0) vendors that matched the search criteria. An additional search of SBA Small Business search engine using keywords “Boston Scientific Corporation” yielded zero (0) vendors, none of which could meet the needs of this requirement.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: N/A

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

Boston Scientific Corporation, 300 Boston Scientific Way, Marlborough, MA 01752

11. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required: N/A

12. 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 and belief.

Camila Leyva Date Biomedical Engineer/COR NYHHS Medical Center – Brooklyn Campus

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer or Designee’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Kimberly Wiatrowski Date Contracting Officer, Services Team 1 RPO East/NCO 2 Contracting Office

CAMILA LEYVA Digitally signed by CAMILA LEYVA Date: 2026.04.27 10:04:23 -04'00'

KIMBERLY WIATROWSKI Digitally signed by KIMBERLY WIATROWSKI Date: 2026.04.28 12:41:42 -04'00'

Acquisition ID#: 36C242-26-AP-2036

b. One Level Above the Contracting Officer (Required over $350K but not exceeding $900K): I certify the justification meets requirements for other than full and open competition.

Joseph Cellino Date Branch Chief, Services Team 1

RPO East/NCO 2 Contracting Office

JOSEPH CELLINO Digitally signed by JOSEPH CELLINO Date: 2026.04.28 12:53:38 -04'00'