P03 CO-Signed PM_Part813.106_689-22-4-7077-0035_CVI-TAP_SSJ_MPT-SAT.pdf

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: 36C241-22-AP-1625

1. Contracting Activity: Department of Veterans Affairs, VISN 01, Department of Veterans Affairs, VAMC West

Haven CT.

PR: 689-22-4-7077-0035

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

VACT (VA Connecticut) is requesting a Circle Cardiovascular (CVI) Circle CMR42 System with TAP Strain (Tissue

Characterization Software). The CVI System will interface with MRI equipment and will provide automated reporting via the

CMR reporting Tool.

The CVI/TAP System will integrate with and enhance outcomes for the MRI Post-processing Program. The Circle CVI (Cardiovascular Imaging) System will provide VACT with tools that take assessment of LV (Left Ventrical) function such as:

diastolic function and strain, quantification of blood flow, quantification of scar and other myocardial characterization, and subclinical assessment of fibrosis, beyond current standards.

The CVI system offers Artificial Intelligence (AI) that will afford automatic segmentation of the cardiac structures to improve precision, accuracy, and efficiency of the post-processing. The CMR (Cardiovascular Magnetic Resonance) reporting tool provide structured reporting and database analytics. The reporting tool has HL7 (Health Level Seven) connectivity which will facilitate the upload of structured reports into CPRS(Centralized Patient Record System) and VISTA. The CVI database analytics supports VA and VACT quality initiatives that will evaluate the utility of Cardiac MRI in our clinical workflow which is paramount in this important resource. CVI is agnostic to MRI scanner type. The CVI System will integrate smoothly with VACT workflow.

The estimated value of the proposed action is $ 101,360.00

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

VACT has two (2) two types of MRI scanners. The Circle CVI, a neutral post-processing program, affords VACT one (1) unified platform to process and compare studies. Currently, VACT uses a suboptimal post-processing program (Qmass). The Qmass platform is inadequate. It is does not allow trainees to to participate in clinical programs. The Qmass post-processing capacity is limited to very basic volume measurements. CVI will afford a broader capacity for perfusion, diastolic dysfunction, and myocardial characterization.

VHA-CT has a high-quality cardiac MRI program with a volume of ~125-150 cases per year. The VACT referral base that covers Western MA and the Hudson River Valley. VACT is unique amongst VA hospitals for its advanced cardiac imaging program. The post-processing capability provided by the CVI/TAP System is required to support interpretation of cardiac MRI studies. VACT has a substantial investment in MRI scanners. The CVI/TAP technology will provide quantification of perfusion, of fibrosis, and of scar is important for diagnosis of myopathic processes, determination of prognosis.

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

Market Research was conducted IAW (In Accordance With) FAR 10.001, FAR 8/VAAR 808.002 (Mandatory Sources) and VAAR 810.001-70 VFCP. Circle Cardiovascular, was selected for its vendor neutral post-processing program. This allows one unified platform to process and compare studies. As previously mentioned, the existing Qmass platform is inadequate for training purposes and only is limited in to post-processing capacity.

The Qmass processing capacity is limited to very basic volume measurements. The CVI/TAP technology will allow a broader capacity for perfusion, diastolic dysfunction, and myocardial characterization. The capabilities provided by CVI/TAP are considered standard in academic cardiac MRI programs.

https://www.acquisition.gov/?q=/browse/far/13

3. Description of market research conducted and results or statement why it was not conducted (cont’d):

Additional Market Research Findings:

Mandatory Sources:

➢ Ability One and FPI: Ability One and FPI do not provide these types of services; they do not service any type of laser system.

➢ Servicing Capabilities by VA and Other Government Agencies: NA.

VAAR 810.001-70 Compliance with VFCP (Veteran’s First Contracting Program): A VetBiz search was conducted using NAICS: 511210 and the Keywords: Cardiovascular Imaging. The search identified four (4) potentially capable SDVOSB VIP-Vendors listed in VetBiz. The VetBiz vendors identified in this search are not authorized to distribute the CVI system with TAP. All CVI with TAP distribution is proprietary, exclusive, and peculiar to the OEM. VFCP cannot be applied.

VAAR 813.003-70(c) VFCP, Rule of Two (38 USC 8127(d): The Rule of Two (2) for VFCP class vendors cannot be met; there are no authorized Circle CVI distributors for the CVI with TAP systems and software.

VAAR 819.202-2 Preference for SD/VOSBs: CVI/TAP distribution is exclusive and proprietary to the

OEM.

FAR 8.002-Mandatory Sources: No mandatory source is authorized to distribute any CVI System.

FAR 8.004-Non-Mandatory Contract Vehicles: The CVI TAP System is an open market procurement.

There are no contracts.

FAR 19.202-2: Preference for Small Business: Only Circle CVI, the LB OE can distribute the CVI with

TAP technology. No Small Businesses can distribute the CVI with TAP system.

Nonmanufacturer Rule (NMR) Findings: Service/Software are the primary element of the CVI

Cardiovascular Imaging Systems. The NMR does not apply. This request is projected to fall below SAT (Simplifies Acquisition Threshold). The LOS does not apply. Per the Sole Source Letter from the Large Business (LB) OEM, Circle CVI is the sole source distributor/provider for CVI Cardiovascular with TAP.

Recommendations: The recommended strategy for the Circle CVI TAP Software and Services procurement is a Sole Source Strategy with the OEM: Circle Cardiovascular Imaging Inc., IAW FAR 13.106-1(b)(1)(i). Although there are four (4) VIP-Certified SDVOSB vendors who are deemed potentially capable for the NAICS/PSC/Description combination: 511210/DA10/Software- Software Services, none of the SDOVSB vendors are capable; they are not authorized to distribute the TAP Software, or to provide maintenance or support services for the same.

The CVI TAP Software, Licensing, Services and Support are peculiar to the OEM. The LB OEM: Circle Cardiovascular Imaging Inc. is unique in their capability to fulfill the follow-on Base + 4 requirement.

They are the OEM and the sole distributor for TAP Software and Services.

4. 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.

Deidra Thomas Contracting Officer Date

VAMC White River Junction VT https://acquisition.gov/far/current/html/Subpart%2013_1.html#wp1125466