Justification for Exception to Fair Opportunity - Siemens (523-B01003) 8.14.2020.pdf

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 Source

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

This Justification for an Exception to Fair Opportunity is on behalf of the VA Boston Healthcare

System Jamaica Pain VA Medical Center located in Boston, MA executed by the Veterans Affairs

National Acquisition Center located in Hines, Illinois.

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

This activity proposes to issue a sole-source delivery order against the High-Tech Medical

Equipment multiple-award Indefinite Delivery, Indefinite Quantity contract SPE2D1-17-D-

0023 awarded to Siemens Medical Solutions USA, Inc.

Delivery Order No.: 36A79720F0253

Purchase Order No. 523B01003

Equipment: MAGNETOM Prisma – MRI System

Manufacturer: Siemens Medical Solutions USA, Inc.

Equipment Cost: $2,921,253.00

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

The completed system will provide a Siemens MAGNETOM Prisma MRI system to support clinical imaging and neuroimaging research for the Neuroimaging Research for Veterans (NeRVe) Center at the VA Boston Healthcare System, Jamaica Plain campus. This will include associated technical services necessary to complete the installation of the MRI Scanner and to provide clinical and technical training.

The estimated total value of this equipment is $ 2,921,253.00.

(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) as only one awardee is capable of providing the supplies required at the level of quality required. The primary purpose of the new MRI Scanner will be in support of neuroimaging research for the

Neuroimaging Research for Veterans (NeRVe) Center. Currently the NeRVe Center is using

Radiology’s Siemens MAGNETOM Prisma, purchased by the local contracting department in

2007. The current system is located in a different building and the facilities’ Neuroscience

Research Building that will house this new dual purpose (i.e., clinical and research) MRI Scanner is currently under construction.

The current MRI Scanner has been used to support all of the neuroimaging research for the VA

Boston Healthcare System over the past five years. Moreover, there are ongoing longitudinal

MAGNETOM Prisma PO# 523-B01003

Source Selection Info – See FAR 3.104 & FAR 2.101 Page 2 of 4 studies using the Siemens MAGNETOM Prisma for the Translational Research Center for TBI

&Stress Disorders (TRACTS) and the Chronic Effects of Neurotrauma Consortium (CENC).

CENC is both a Veterans Administration and Department of Defense that has continued under the new name of Long-Term Impact of Military-Relevant Brain Injury Consortium Chronic Effects of

Neurotrauma Consortium. Currently there are approximately 25 Principal Investigators, students, post-doctoral fellows, and other trainees using the Siemens MAGNETOM Prisma, that is currently in use, for neuroimaging research. Switching to another MRI Scanner platform would adversely impact their ongoing research efforts. Additionally, several of the facilities’ investigators are involved with using the Human Connectome Sequences related to human disease, which are specifically supported by the MAGNETOM Prisma. A different MRI scanner platform would not have the same qualities as the MAGNETOM Prisma MRI platform. Purchasing an MRI other than the MAGNETOM Prisma would disrupt the current ongoing research.

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

The contracting officer for the resultant order has determined the prices offered to be fair and reasonable for this justification for an exception to fair opportunity. All items are priced at or below the contract price, which was previously determined fair and reasonable at time of contract award, and there have been no significant changes to the industry or market conditions that would result in changes to the reasonableness of the underlying contract prices.

(6) Any other facts supporting the justification.

The MAGNETOM Prisma has the strongest Clinical Gradients available in the marketplace at

80/200 XR Gradients. The gradient was modeled on the experience gained in the early phases of the Human Connectome Project (HCP) and supports our use of HCP sequences for several studies that are underway through the NeRVe Center. The sequences that the facility is currently using are

Simultaneous Multi-Slice Echo Planar Imaging (SMS EPI) (aka multi-band) working together with

Massachusetts General Hospital (MGH) and Common-mode Rejection Ratio (CMRR). The

Siemens MAGNETOM Prisma product implementation is the closest to the HCP multi-band sequences. Siemens SMS BOLD can acquire up to SMS 8 and SMS 3 for diffusion. In both cases, in-plane GRAPPA can be used to reduce transmission errors and distortion. This is a unique capability of Siemens SMS EPI that is only resident on the MAGNETOM Prisma. The NeRVe

Center Director, Dr. David Salat has also used the Prisma for the HCP aging.

The architectural design of the Neuroscience Building requires that the calculations for the magnet

Isocenter and shielding be validated before the construction begins. Construction for the

Neuroscience building is underway and expected to be completed in early 2021. These calculations were based upon the MAGNETOM Prisma and have been reviewed by the architectural team, VA Boston Engineering, and VA Boston Clinical Engineering. Acquisition of any other MRI Scanner would adversely impact the completion of the Neuroscience Building and result in costly construction changes.

The MAGNETOM Prisma is the most widely used standard instrument for contemporary behavioral and cognitive neuroscience investigation internationally. The Siemens will continue to allow investigators at VA Boston to directly reference and adopt studies and techniques in relevant scientific disciplines, and conversely will allow scientists around the VA system, and academic institutions in the US and other countries to access our scientific discoveries.

Source Selection Info – See FAR 3.104 & FAR 2.101 Page 3 of 4

The NeRVe Center at VA Boston has licensed software, sequences, and other technological developments that come out of the Siemens development site at the MGH Martinos Center for

Neuroimaging. This is a tremendous advantage, as the facility does not have the resources to employ the cadre of MR physicists, computer scientists, and other investigators in the forefront of medical imaging technology. This has allowed the facility neuroimaging center to be in the forefront of research relevant to Veterans health.

VA Boston NeRVe Center has accumulated a decade of longitudinal data representing many millions of dollars of research funding and intellectual effort of dozens of scientists. The scientific value of these data would be destroyed if the facility switched scanners to another platform.

(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.

All prospective delivery orders are competed among all contract holders. Once an order is placed for proprietary equipment, it is generally not possible to compete follow-on acquisitions for upgrades because the system to be upgraded is proprietary in nature. 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 when appropriate.

(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 Contracting Officer hereby certifies that the justification is accurate and compete 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 Facility Biomedical Engineer hereby certifies that the justification is accurate and compete 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)(C).

Source Selection Info – See FAR 3.104 & FAR 2.101 Page 4 of 4

CERTIFICATION AND APPROVAL

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.

Lisa Bradley Date

Facility Biomedical Engineer

VA Boston Health Care System – Jamaica Plain VAMC

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.

Stephanie E. Thigpen Date

Contracting Officer (orders less than $700,000)

VA National Acquisition Center – Hines

High-Tech Medical Equipment Ordering Division

Reagan Criddle Date

Chief HTME Ordering Division

VA National Acquisition Center – Hines

High-Tech Medical Equipment Ordering Division

COMPETITION ADVOCATE APPROVAL:

Craig Robinson Date

Competition Advocate (orders > $700,000 up to $13,500,000)

VA National Acquisition Center – Hines

Associate Executive Director

Pursuant to 16.505(b)(2)(ii)(C))

Date8_af_date: 7/31/2020