20-003961-PurchaseDescriptionEvalFMRIF7T_upgrade_v2b.pdf

Version 11-30-2016-1 FAR Part 11—Describing Agency Needs

PURCHASE DESCRIPTION

1 Statement of Need and Purpose The National Institute of Mental Health functional MRI Facility (FMRIF) is a core resource of the National Institutes of Health (NIH) intramural research program mandated to provide researchers with access to state-of-the-art equipment, tools, and techniques for their experiments.

To meet this requirement, it is necessary that the FMRIF have the most modern, capable equipment available. For these reasons, it is necessary to upgrade or replace aging equipment that has become obsolescent to provide the state-of-the-art imaging capabilities needed to support the current and future demands of cutting-edge research.

2 Background Information and Objective The function of the FMRIF is to serve as a resource by which all NIH institutes can perform Magnetic Resonance Imaging (MRI) studies that further the understanding of healthy and diseased brain anatomy, function and physiology. The FMRIF is located within the NIH MRI Research Center .

The FMRIF currently operates four 3T (Skyra 3T, 3 x Discovery MR750 3T) and one 7T human MRI system (Magnetom 7T VB17). FMRIF users and staff also have significant scanning access to a Prisma 3T and a Terra 7T VE12. All of these scanners are located in the NIH MRI Research Center .Over the last few years, MRI at 7T has advanced significantly, particularly for Neuro applications such as functional MRI (fMRI) and diffusion methods (DTI, DSI). The existing FMRIF 7T VB17 system was installed in 2010 based on an engineering platform that is now two generations old. Support for the system has been phased out by the vendor. The FMRIF users must have the most modern equipment available to provide researchers with access to the latest equipment, tools, and techniques for their experiments.

The specific objective of this purchase is for the upgrade or replacement of the existing FMRIF Magnetom 7T VB17 MRI System. The acquisition shall include either (a) upgrading of the electronics and support systems of the existent 7T MRI system, or (b) complete replacement of this 7T MRI Scanner . The upgraded or replacement system is to be used for clinical and preclinical human MRI research.

3 Generic Name of Product Upgrade or replacement of a Siemens Magnetom 7T MRI System.

4 Purchase Description The FMRIF requires the upgrade or replacement of an existing high field (i.e. 7 Tesla) MRI system to a 7T MRI System suitable for state-of-the-art functional MRI research.

The original vendor offers an product upgrade suitable for our existing system which is referred to as the 7T Plus Upgrade (Siemens part number: SP02RD1765) which is further described as:

7T Plus Upgrade includes:

1. Single transmit System host upgrade for VE12 software line

2. Parallel transmit (8Tx) host upgrade for VE12 software line

3. Control system and imager upgrade (MARS)

4. Parallel transmit upgrade to the Terra-generation pTx system including 8 transmit channels (EPC 2)

5. Software packages for Single transmit system

6. Software packages for Parallel transmit system (8Tx)

7. QED Tune-Up coil (not for human imaging)

We seek an upgrade or replacement of our Magnetom 7T that provides a resultant MR system substantially equivalent to the 7T Plus upgrade.

The completed installation may be an upgrade of current equipment or replacement of current equipment. The current equipment is a Magnetom 7T system (FMRIF-7T) which comprises a Magnetom console and electronics: VB-platform, 32-channel receive, 8-channel pTx step 2.3 transmit with multinuclear imaging capability) in combination with an Agilent 7T-830/AS magnet (Functional Location Number: 400-342363).

For the purposes of this requirement, any replaced subsystems of the existing 7T MRI System (including up to the complete system) will be available for Trade-In. Existent equipment that is to be replaced shall be removed by the contractor.

The project shall be accomplished as a turn-key installation so that all site preparation, removal and modifications as well as all the steps needed for NIH design review shall be included as parts of a single contract.

5 Salient characteristics

5.1 General System Performance Requirements

The upgraded or replaced MRI System must be capable of collection of state-of-the-art images of the brain for functional MRI using Echo Planar Imaging (EPI), diffusion MRI (dMRI) including diffusion tensor imaging (DTI), diffusion spectrum imaging (DSI), and routine high-resolution neurological and structural brain imaging. Specific MRI methods that must be supported include multi-band (i.e. simultaneous multi-slice), multi-echo and 3D-EPI.

Pulse sequence software and software development environment for the MRI System shall be included so that pulse sequences can be modified by NIH investigators. Experimental MRI pulse sequences must be sharable with other researchers in the field. Real-time streaming access must be provided for the acquired magnetic resonance raw data for in-house developed image reconstruction.

5.2 Magnet Field Strength and Bore Size

The upgraded or replacement MRI system shall have a magnetic field strength of 7T. The minimum patient accessible bore diameter of the system with the gradient hardware subsystems in place shall be 60cm. The bore must provide sufficient space to accommodate additional equipment for fMRI include the presentation of visual and audible stimuli, eye tracking and head-motion tracking.

5.3 Gradients

The upgraded or replacement MRI System shall have gradient subsystems capable of providing a maximum gradient strength of at least +/-70 mT/m along each physical (X, Y, Z) gradient axis both independently and simultaneously. The magnetic field gradient for each physical (X, Y, Z) gradient axis must be capable of being slewed independently and simultaneously at 200mT/m/ms through all gradient amplitudes up to this maximum gradient strength.

5.4 Radiofrequency Receiver System & Coils

The upgraded or replacement MRI System shall provide a minimum of 64 receiver channels capable of simultaneous (parallel) operation providing at least 500kHz bandwidth on each channel with at least16 bit dynamic range. The system shall include a potential future upgrade option that allows up to at least 128 channel parallel operation.

5.5 Radiofrequency Transmit System

The upgraded or replacement MRI System shall provide a head transmit coils capable of operating in quadrature (i.e. circularly polarized mode) and also in full parallel transmit mode providing at least 8 transmit channels with full independent control of RF phase and amplitude on each transmit channel. RF transmit amplifiers should supply at least 8 kW pulsed, linear, power at 298 MHz when operated in the single channel mode. In the parallel transmit mode, each transmit channel amplifier shall be capable of delivering at least 1 kW. All RF channels shall be driven by independent waveform generators with at least 256 k waveform memory and capable of amplitude and phase modulation. A minimum of eight separate pulse shapes shall be able to be used within one pulse sequence. Frequency and phase control shall be within 0.1 Hz and 0.05 degrees, respectively. There shall be at least 40 dB amplitude gain and RF pulse timing resolution shall be at least 2 microseconds.

5.6 Multi-nuclear imaging capabilities

The upgraded or replacement MRI System shall include the so-called multinuclear option. That is, the capability to perform NMR and MRI procedures and collect data from other nuclei (i.e. 13C, 19F, 23Na and 31P) in addition to 1H proton imaging. The multinuclear receiver system should provide at least 8 channels with at least 500kHz bandwidth. The 1H transmit system shall be configured to allow 1H decoupling during multinuclear spectroscopy studies. The broadband power amplifier shall be capable of delivering at least 8 kW.

5.7 RF coils and T/R switches

The system must include head coils suitable for use in fMRI, dMRI and other neurological applications.

a) The vendor shall provide the following integrated RF coils suitable for 1H MRI of the human head:

• Single channel volume transmit and 32 channel receive array (1Tx/32Rx)

• Eight channel transmit array and 32 channel receive array (8Tx/32Rx)

• Single channel surface, receiver coil (5 cm diameter)

b) Transmit-receive switches that will operate at 31P, 13C, and 23Na frequencies shall be provided.

c) The vendor shall provide a mechanism to allow the use of customer developed RF coils.

A body RF coil is not required.

5.8 Gating and Physiological Monitoring

The upgraded or replacement MRI System shall provide a capability for physiological gating and monitoring including vector ECG, respiratory, and pulse-oximetry. Additionally, the system shall be capable of gating using an external triggering signal.

5.9 Image Reconstruction Systems

The image reconstruction system of each upgraded or replacement MRI System must be capable of reconstructing images in real-time when acquiring parallel imaging data. Specifically, the system must be able to perform reconstruction of 3D and multi-band (i.e. simultaneous multi-slice) parallel imaging data (EPI, matrix size 192x128, acceleration factor 2-16, 1mm slice thickness and maximum number of slices per TR) acquired with 64 receive coils at a frame rate of at least 15 frames per second for at least 30 minutes. The reconstruction hardware must feature a minimum of 1TB RAM and a 64 bit multiprocessor system (16 cores minimum). The reconstruction system must be programmable by NIH investigators. Reconstruction software and a reconstruction software development environment shall be included so that pulse sequences can be modified by NIH investigators. Reconstruction software must be sharable with other researchers in the field.

5.10 Software

The upgraded or replacement MRI System shall each come with state-of-the-art software packages for sequence and reconstruction to enable functional MRI, diffusion MRI, and routine neurological imaging including Echo Planar Imaging including multiband (i.e. simultaneous multi-slice), multi-echo, 3D-EPI and high-resolution structural imaging. The upgraded or replacement MRI System must be fully programmable such that end users and investigators can modify and customize the MRI pulse sequences and perform customized image reconstruction with access to Original Equipment Manufacturer (OEM) reconstruction software routines. This access must be included by the OEM when providing the upgraded or replacement MRI System.

5.11 External network interfaces

The upgraded or replacement MRI System must be able to connect to modern Picture Archiving and Communications System (PACS) systems for image transfer. The system must be capable of interfacing with HL7 (Health Level 7) PACS.

5.12 Installation of MRI System

The successful offeror shall design and perform all related renovations including, but not limited to, necessary repair/replacement of walls, flooring, ceiling, radiofrequency shielding, electrical and mechanical systems and other facility related changes in order to accommodate the upgraded or replacement MRI System. In addition, the contractor shall remove the parts of the existing MRI system that are being replaced (up to and including the whole system). These shall be used as a “trade-in” toward the purchase of the upgrade or replacement for the existing MRI system. All labor, materials, associated shipping, etc., required for site preparation and installation shall be provided by the successful offeror.

All renovations and installations shall be staged to minimize disruption to existing NIH, FMRIF and NMR Center operations. Electromagnetic interference and vibration shall be reevaluated if the proposed magnet is more sensitive to their effects than the existing.

Efforts shall conform to all applicable federal, national, international, and local codes. The project shall also conform to the latest edition (at award) of the NIH Design Requirements Manual (DRM).

NIH will review the design for regulatory compliance and general engineering and architecture approaches. All comments must be responded to by the A/E in an effort to seek resolution. If applicable, this effort shall continue until resolution is found. It is expected that each submission review will be completed in 15 business days. Comments will be accessed by the A/E through the DTR Permit Review system. The A/E is expected to respond to NIH responses in 5 business days after receipt of responses. NIH reserves the right to reject a submission at no cost to the government if the design fails to meet DRM submission guidelines, strongly disregards regulations, or shows a strong lack of understanding of constructability and intent of the project.

The Designer shall propose the number of submissions for NIH approval, but it is suggested that the design is submitted at 50%, 75%, 95% (final), and 100% (backcheck).

The Contractor, with the Project Officer’s assistance, is responsible for obtaining all permits prior to installation. This includes, but is not limited to; DTR Design Permit (obtained through closing out review comments and a successful design), Interim Life Safety Measures (ILSM, through Fire Marshal), Construction Risk Assessment (CRA), Utility Moratorium waivers, Hot Work Permits, etc. Joint Commission requirements shall be upheld throughout construction.

The contractor shall present an updated schedule bi-weekly, to include important milestones as requested for coordination purposes. The schedule shall be presented in Microsoft Project or Primavera P6, and shall be of adequate detail, separating significant features of work.

5.13 MRI System Training

The successful offeror shall provide on-site training to four (4) FMRIF staff in all hardware and software that will be required for routine operation of the upgraded or replacement MRI System.

The Contractor shall additionally provide training in pulse sequence and reconstruction software development for staff involved in methods development.

5.14 Warranty of MRI System

The upgraded or replacement MRI System shall come with a minimum of a twelve (12) month warranty include parts and labor. During the warranty period, the contractor shall provide maintenance support and equipment and software upgrades in accordance with industry standards.

5.15 Warranty Period Maintenance and Upgrade Support

The contractor must provide on-site maintenance service and upgrade support for the complete upgraded or replacement MRI System: i.e. all the upgraded, substituted or replacement subsystems, and all the retained subsystems from the existing Siemens Magnetom 7T, (including the 7 Tesla magnet and associated hardware, gradient power chain, RF transmit and receive chains).

The on-site maintenance service shall ensure the MRI System remain operable and fully functional. The system must be operational according to manufacturer specifications with high predictability and reliability to support their operation in the NIH FMRIF. These system will be in heavy use, and any system unavailability (“downtime”) will impact a wide range of clinical research studies at the NIH and the mission of the NIH FMRIF.

a) Preventative maintenance visits will be done at least once per month.

b) An onsite response time of 8 hours with personnel familiar with the site and the equipment.

c) Immediate phone support with remote monitoring/diagnostics of the MRI system.

d) Any major platform upgrade announced within the warranty period will be provided free of charge

e) Any major platform upgrade (electronics, reconstruction or gradient hardware) that is available within two years after the expiration of the warranty shall be made available to the FMRIF at a discount of 75%.

5.16 Post- Warranty Maintenance Support

Ongoing maintenance renewable annually for at least 5 years from system installation including the initial warranty period. The post-warranty service agreement will provide the following (similar to above):

a) Take service calls for all issues on the upgraded or replacement MRI scanner

b) Diagnose all issues that arise on the upgraded or replacement MRI scanner

c) Repair all issues that arise on the upgraded or replacement MRI scanner

d) Function as experts regarding the maintenance, repair, and upkeep of the upgraded or replacement MRI scanner

e) Perform regular preventative maintenance (monthly)

f) Provide the general tools and equipment necessary to perform the above

g) Provide support for modifications to hardware and software made by customer

5.17 Additional Requirements Due to Research Needs

The Government requires that the successful offeror provide tools for pulse sequence and reconstruction programming. Further, source code for any sequences installed on the system shall be provided upon request as part of this requirement. This information will be used by NIH investigators to modify existing MRI pulse sequences and develop new MRI pulse sequence and reconstruction components for research purposes.

The NIMH shall assure confidentiality of this information to the contractor or enter into a Collaborative Research and Development Agreement (CRADA) for research development of features dependent on this functionality.

6 Quantity One.

7 Delivery Date The upgrade or replacement for the existing FMRIF-7T Siemens Magnetom 7T MRI scanner shall be performed by September 2021.

8 Period of Performance The period of performance for this requirement shall be twelve (12) months from date of contract award. This period of performance shall include site preparation, upgrade or replacement of MRI System and associated installation, and training. Warranty and associated maintenance and future upgrade support shall be provided for the warranty duration.

The location of the existent equipment (i.e. FMRIF-7T) and where upgraded or replacement MRI scanner and associated equipment shall be located and all efforts for this requirement shall take place is as follows:

NMR Center, NIH Clinical Center 10 Center Drive, Rooms B1D708 Bethesda, MD 20892.

9 Options

9.1 Option for the Extension of Service/Maintenance contract

An option is sought for the extension of the maintenance and warranty service for the complete upgraded or replacement 7T MRI system, all the upgraded, substituted or replacement subsystems, and all the retained subsystems from the existing Magnetom 7T, (including the 7 Tesla magnet and associated hardware, gradient power chain, RF transmit and receive chains).

This maintenance service extension option may provide for extension of warranty maintenance for up to 5 years from the initial upgrade or replacement installation, and will provide the following:

a. Take service calls for all issues on the upgraded or replacement MRI scanner

b. Diagnose all issues that arise on the upgraded or replacement MRI scanner

c. Repair all issues that arise on the upgraded or replacement MRI scanner

d. Function as experts regarding the maintenance, repair, and upkeep of the upgraded or replacement MRI scanner

e. Perform regular preventative maintenance (monthly)

f. Provide the general tools and equipment necessary to perform the above

g. Provide support for modifications to hardware and software made by customer