P03 Special Priority Justification FAR 13 Avvigo_Redacted.pdf

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6525--RFQ - Brand Name AVVIGO MULTI-MODALITY GUIDANCE SYSTEM Federal contract opportunity
Solicitation number
36C24224Q0463
Issued by
Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 2

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This document contains a justification for a single source award according to FAR 13.106-1. The Department of Veterans Affairs is seeking to procure one Boston Scientific AVVIGO Mobile Guidance System for the Margaret Cochran Corbin VA Medical Center Catheterization Laboratory. The system utilizes intravascular ultrasound and invasive physiology to perform percutaneous coronary interventions, which are indicated in American Heart Association and American College of Cardiology guidelines for complex coronary stenting procedures. The system will allow staff to move between rooms as needed during a cath lab renovation project expected to last six months to one year, and for higher risk procedures in the hybrid operating room. No other brands would be compatible with the current system in use or meet the needs of the using service without disrupting standardization or causing unacceptable delays in patient care. Market research found no SD/VOSB or GSA sources for the product. The contracting officer approved and certified the justification.

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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: 36C242-24-AP-1977

1. Contracting Activity: Department of Veterans Affairs, VISN 02, Network Contracting Office, Appletree Business Park, 2875 Union Road, Suite 3500 Cheektowaga, NY 14227.

Organizational Activity Margaret Cochran Corbin VA Campus, 423 E 23rd Street, New York, NY 10010 thru 2237# 630-24-2-3086-0107.

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

The Margaret Cochran Corbin VA Medical Center Catheterization (Cath) Laboratory is requiring the brand name *special priority* purchase of one (1) Boston Scientific AVVIGO Mobile Guidance System to aid with intravascular imaging and inform treatment decisions, including more efficient treatment procedures such as angioplasties and atherectomies for patients with coronary artery disease.

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

The Boston Scientific AVVIGO Mobile Guidance System utilizes a high-definition intravascular ultrasound and invasive physiology to perform percutaneous coronary intervention in the cath lab, which is a class 2a indication in the American Heart Association and American College of Cardiology.

Guidelines indicate the importance of using intravascular ultrasound in patients undergoing coronary stent implantation, especially in cases of complex coronary stenting. Complex coronary stenting makes up many of the procedures performed at Margaret Cochran Corbin VA Medical Center.

Currently, there is an earlier generation system in use at the cath lab (located on 12 W), and it is installed in each room and is not mobile. The program office is requiring a system on the 6th floor, to conduct all cath procedures during the 12 W cath lab renovation project. The project is expected to last at least 6 months to 1 year. Additionally, staff will be doing higher risk procedures in the hybrid OR moving forward, which is also located on the 6th floor. Boston Scientific AVVIGO Mobile Guidance System allows staff to move from room to room as needed. Use of any other brand will not be compatible with current system in use, and it will disrupt the standardization of equipment across the facility. The required *special priority* brand name Boston Scientific AVVIGO Mobile Guidance

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

System meets the needs of the using service and allows staff to provide high quality care to veterans and avoid unacceptable delays in patient care.

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

A search on SBA DSBS yielded zero (0) SD/VOSBs.

A search on GSA yielded zero (0) results. A search on Supply Chain Master Catalog (SCMC) yielded 0 results.

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.

Janelle Bonafede Date Contracting Officer

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