36H79719D0016-003.pdf

1 Page Source Selection Info – See FAR 3.104 & FAR 2.101

DEPARTMENT OF VETERAN AFFAIRS

Office of Acquisition and Logistics

National Acquisition Center

P.O. Box 76

Hines, IL 60141

Justification for an Exception to Fair Opportunity

FAR 16.505(b)(2)(i)(B) – Only One Capable Source

(1) Identification of the agency and the contracting activity.

This Justification for an Exception to Fair Opportunity is on behalf of VISN 1, Boston, MA

VAMC Healthcare System, and will be executed by, the Veterans Affairs National Acquisition

Center (NAC) located in Hines, Illinois.

(2) Nature and/or description of the action being approved.

This activity proposes to issue a sole-source delivery orders against Indefinite Quantity contract

36H79719D0016 awarded to Riverain Technologies for the purchase of an enhancement to the existing VISN 1, Boston, MA VAMC Healthcare System network commercial Picture Archive and Communication System (PACS). This acquisition is for software, hardware, user licensing, and initial product support and training.

(3) A description of the supplies or services required to meet the agency’s needs, including the estimated value.

Computer Aided Diagnostic (CAD) tools for the enhancement of the diagnosis of lung cancer. Specifically, CAD that detects all forms of early stage lung nodule types and has the capability, using Artificial Intelligence (AI) algorithms to remove vessels and other anatomy that might obscure pathology.

Provision of all required software, hardware, licenses, support and training for all VISN

1 sites where direct interpretation of lung cancer screening exams is performed and outlined in the quotes submitted for each of the following sites:

072419-CT-CRBS-Manchester

072419-CT-CRBS-Brockton

072419-CT-CRBS-Jamaica

072419-CT-CRBS-Newington

072419-CT-CRBS-Northampton

072419-CT-CRBS-Providence

072419-CT-CRBS-Togus

072419-CT-CRBS-WestHaven

072419-CT-CRBS-WestRoxbury

072419-CT-CRBS-WRJ

The total estimated value is $1,225,600.00.

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(4) An identification of the exception to fair opportunity (see 16.505(b) (2)) and the supporting rationale, including a demonstration that the proposed contractor’s unique qualification or the nature of the acquisition requires use of the exception cited. If the contracting officer uses the logical follow-on exception, the rationale shall describe why the relationship between the initial order and the follow-on is logical (e.g. in terms of scope, period of performance, or value).

The order will be issued on a sole-source basis in accordance with FAR 16.505 (b)(2)(i)(B).

This Purchase Order# 523-B91020 will be awarded under IDIQ contract 36H79719D0016.

Clear Read X-ray Bone Suppression is an innovative image enhancement technology/software that is vendor neutral, designed to increase the clarity of chest X-rays by suppressing bone on digital images. Clear Read CT is the only CAD/AI system FDA approved for concurrent read with all pulmonary nodule types (Solid, sub-solid and ground glass) Input images maybe derived from several modalities (DR, CR and/or CT) which are processed through our PACS provider

(Philips/Carestream) with the output images being sent to one or more Diagnostic Workstations.

All image transfer protocols are compliant with the DICOM 3.0 standards.

Riverain Technologies is the only source that provides this software with the ability to identify all types of nodules as it is proprietary in nature. They are the only vendor that can provide the supplies and or services that meet the Government needs.

This purchase request will be issued on a sole-source basis as only one such awardee can provide the supplies or services required at the level of quality required for the workstation integration package. No other manufacturer can provide the necessary technology to upgrade the current purchased system with the VA without losing compatibility and functionality of the entire system.

Market research included visits to multiply large and small vendors (GE, Philips, Siemens, Vital Images, TeraRecon, etc.) at the Radiology Society of North America (RSNA)

Conferences over the past two years between 2018 – 2019; specific concentration on the

Artificial Intelligence (AI) for lung cancer screening and diagnosis. Multiple vendors have an

AI or Computer Aided Diagnosis (CAD) solution for lung cancer however, Riverain

Technologies is the only vendor that has an AI solution that detects and characterizes all forms of lung nodules. Riverain Technologies is the only company that has this high rate of sensitivity and specificity for detecting “ground glass” lesions. All items are currently on

Riverain Technologies IDIQ contract 36H79719D0016. Riverain Technologies is offering the

Government an additional 20% discount off their contract price, this is an additional savings for the government of $306,400.00.

(5) A determination by the Contracting Officer that the anticipated cost to the Government will be fair and reasonable.

All items are currently on Riverain Technologies IDIQ contract 36H79719D0016. The quoted price for each item is at or below the IDIQ not-to-exceed contract price, and the IDIQ contract pricing has been determined fair and reasonable by a contracting officer in accordance with 13.106-3, 14.408-2 and subpart 15.4.

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(6) Any other facts supporting the justification.

Riverain Technologies is the manufacturer and is FDA approved for the ClearRead+Detect;

ClearRead X-Ray Detect. This information is known only to Riverain Technologies. Updating the software to the PACS system that was purchased in FY2015 will allow the VA to maintain the best quality of care for the veterans. This software is also valuable in the support of

COVID-19 diagnosis and treatment planning.

(7) A statement of the actions, if any, the agency may take to remove or overcome any barriers that led to the exception to fair opportunity before any subsequent acquisition for the supplies or services is made.

Future requirements will be handled on a case by case basis and all attempts will be made to provide fair opportunity to all schedule holders.

(8) The contracting officer’s certification that the justification is accurate and complete to the best of the contracting officer’s knowledge and belief.

By signing this justification, the requiring activity hereby certifies that the justification is accurate and complete to the best of their knowledge.

(9) Evidence that any supporting data that is the responsibility of the technical or requirements personnel (e.g., verifying the Government’s minimum needs or requirements or other rationale for an exception to fair opportunity) and which form a basis for the justification have been certified as complete and accurate by the technical or requirements personnel.

By signing this justification, the requiring activity hereby certifies that the justification is accurate and complete to the best of their knowledge.

(10) A written determination by the approving official that one of the circumstances in

(b)(2)(i)(A) through (F) of this section applies to the order.

Based on the information contained herein, a determination has been made that this requirement meets the exception at FAR 16.505(b)(2)(i)(B) because only one awardee is capable of providing the supplies or services required at the level of quality required because the supplies or services ordered are unique or highly specialized. All awardees were given a fair opportunity to be considered for the original order.

CERTIFICATION AND APPROVAL

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TECHNICAL/REQUIREMENTS CERTIFICATION:

Pursuant to FAR 16.505(b)(2)(ii)(B)(9), I certify that any supporting data that is my responsibility and which forms a basis for the justification is complete and accurate to the best of my knowledge and belief.

Keith Thibault RT (R, CT) Date

VISN 1

Radiology Program Manager

CONTRACTING OFFICER CERTIFICATION:

Pursuant to FAR 16.505(b)(2)(ii)(B)(8), I certify that the justification is complete and accurate to the best of my knowledge and belief.

Ann English Date

Contracting Officer

VA National Acquisition Center – Hines

High-Tech Medical Equipment Ordering Division (003B6C2)

Monica Mende Date

Chief

VA National Acquisition Center –Hines

High-Tech Medical Equipment Ordering Division (003B6C2)

COMPETITION ADVOCATE APPROVAL:

Craig Robinson Date

Associate Executive Director

National Acquisition Center – Hines