36C26123P1110_1.docx

Justification and Approval Notice Justification and Approval Notice

GENERAL INFORMATION

BASE NOTICE TYPE

Network Contracting Office 21 VA Northern California HealthCare System 5342 Dudley Blvd, Bldg 209 McClellan CA 95652-2609

POINT OF CONTACT*

Amanda Hildreth amanda.hildreth@va.gov

AWARD INFORMATION

MODIFICATION NUMBER

AWARDEE NAME*

CONTRACTOR’S UEI

CIRCLE CARDIOVASCULAR IMAGING INC

TTXUXZE3LCZ5

AWARDEE ADDRESS LINE 1*

AWARDEE ADDRESS LINE 2*

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

DESCRIPTION

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: Circle Cardiovascular Imaging (CVI) Software 36C261-23-AP-2460

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office (NCO) 21 on behalf of VISN 21, VA Palo Alto Healthcare System (VAPAHCS).

2237#: 640-23-2-097-0016

2. Nature and/or Description of the Action Being Processed:

The VA Palo Alto Healthcare System has a requirement for Circle Cardiovascular Imaging (CVI) Software Licenses with support services. The purpose for obtaining the Circle CVI Software is for comprehensive reading and reporting solution that encompasses Cardiac MR and CT that encompasses fully automatic Quantitative Perfusion, 4D Flow, myocardial Strain, Electrophysiology, and Interventional Planning. With the embedded AI, one is able to get faster reproducible reading and reporting with optimized cardiovascular workflows, while reducing user dependence and workloads, saving physicians more time.

The workflow solution offered by Circle CVI offers the most clinically cleared tools for diagnosis and the most accurate tools to quantify and qualify for research purposes. With this software, the VA Palo Alto Radiologists will easily be able to detect wall motion abnormalities, as well as auto display of stroke volume, ejection fraction, and end diastolic. They will also be able to access transmittal flow patterns, pulmonary vein forward flow, aortic size, and quantification of shunt sizes. The quantitative perfusion add on will provide objective, user-independent, fully automatic quantitative analysis of myocardial blood flow with expert level accuracy. Overall, it allows the team to deliver the best experience and care to Veteran patients by diagnosing accurately and creating a treatment plan to meet their needs.

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

The VA Palo Alto Healthcare System has a requirement for Circle Cardiovascular Imaging (CVI) Software Licenses with support services. Base plus four (4) options years for the following items:

4. Statutory Authority Permitting Restricted Competition:

FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below:

(X ) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements

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

VA Palo Healthcare system has the Circle CVI Software installed for use by the Radiology Department. The workflow solution offered by Circle Cardiovascular Imaging, Inc. uniquely offers the most clinically cleared tools for diagnosis and the most accurate tools to quantify and qualify for research purposes. With this software, the VA Palo Alto Radiologists will easily be able to detect wall motion abnormalities, as well as auto display of stroke volume, ejection fraction, and end diastolic. They will also be able to access transmittal flow patterns, pulmonary vein forward flow, aortic size, and quantification of shunt sizes. The quantitative perfusion add on will provide objective, user-independent, fully automatic quantitative analysis of myocardial blood flow with expert level accuracy. Overall, it allows the team to deliver the best experience and care to Veteran patients by diagnosing accurately and creating a treatment plan to meet their needs.

Market research has determined there is no other software on the market that meets the needs of the requirement. Circle CVI Software is proprietary to the manufacturer and there are no authorized distributors.

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

Refer to paragraph 8 below for more details.

The Contracting Officer published Sources Sought Notice #36C26123Q530 to Contract Opportunities from 3/30/2023-4/6/2023. No responses received as a result of the sources sought notice.

Other: The Contracting Officer sent an email to the OEM, Circle Cardiovascular Imaging, Inc, requesting information on the existing contracts and authorized distributors. The OEM confirmed there are no existing contracts, and this software is proprietary to their company, no authorized distributors available.

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

The Contracting Officer will determine price fair and reasonableness by comparing to the existing/previous contract prices of the same supplies.

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

The Contracting Officer conducted a VetCert search for NAICS 513210 yielded 29 results. VetCert search for UEI TTXUXZE3LCZ5 (Circle Cardiovascular Imaging) yielded zero (0) results.

The Contracting Officer conduced a search on GSA Advantage for “circle CVI software”, no results. The OEM, Circle Cardiovascular Imaging, Inc, confirmed the required software is not on existing FSS or other contracts.

The Contracting Officer conducted an FPDS search for “circle CVI software” found several prior purchases made by the Department of Veteran Affairs, all awarded IAW FAR 13 to the OEM, Circle Cardiovascular Imaging, Inc.

The Contracting Officer conducted reviewed the Acquisition history: NCO 21 awarded 36C26118C0138 for VA Palo Alto for the same requirement. This contract was sole sourced to OEM, Circle Cardiovascular Imaging, Inc. The market research concluded that the Circle CVI Software is proprietary to the OEM.

The Contracting Officer published Sources Sought Notice #36C26123Q530 to Contract Opportunities from 3/30/2023-4/6/2023. No responses received as a result of the sources sought notice.

Other: The Contracting Officer sent an email to the OEM, Circle Cardiovascular Imaging, Inc, requesting information on the existing contracts and authorized distributors. The OEM confirmed there are no existing contracts, and this software is proprietary to their company, no authorized distributors available.

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

There are no other facts.

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

Circle Cardiovascular Imaging, Inc., SAM UEI: TTXUXZE3LCZ5 800 5 Ave SW

STE 1100

Calgary, Canada

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:

VA Palo Healthcare System and Networking Contracting Office (NCO) 21 will continue market research for future requirements.

Justification and Approval Notice