Attch 1 - Purchase Description.pdf

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

PURCHASE DESCRIPTION

Brand Name or Equal: Portable MRI System

National Institute of Neurological Disorders and Stroke, Translational Neuroradiology Section

1. Statement of Need and Purpose: The purpose of this requirement is to procure:

1) an ultra-low-field portable magnetic resonance imaging (MRI) machine that is brand-name or equal to Hyperfine Research’s Portable Point-of-Care Mark 1.5 MRI system, and 2) maintenance services for the MRI system. This will allow National Institute of Neurological Disorders and Stroke (NINDS) investigators to screen patients with multiple sclerosis (MS) on their bedside as opposed to transferring them to an imaging facility.

2. Background Information and Objective: The National Institutes of Health (NIH) Clinical Center is the largest research hospital in the world. Within the Clinical Center, NINDS has supported an active clinical research program in MS since 1975. MRI research has been a major focus of this program since the late 1980s, which has led directly to the development of the MRI-based clinical trial designs and resulted in the approval of nearly 20 disease-modifying therapies.

The MRI-based MS natural history study has more than 1000 enrollees;

approximately 350 are followed annually at the Clinical Center, however, additional participants can be recalled. MRI data is currently collected and analyzed in the Translational Neuroradiology Section, where new advanced MRI methods — including methods developed on two 7-tesla scanners — are also designed and tested. This research program is funded by NINDS’ Intramural Research Program.

There has been a continuous effort in order to be able to identify and intervene early in individuals at high-risk of MS. While the current risk-stratification algorithm is promising, it is insufficient on its own to reliably identify either asymptomatic MS cases or individuals who will develop MS in the future.

As a result, NINDS is planning to conduct a larger-scale portable MRI study, which will entail loading the MRI system onto a van and driving it around the country to scan people at risk of developing multiple sclerosis but who are not currently sick. This would not be possible with a conventional MRI system.

3. Product Information:

Generic Name of Product: Ultra-Low-Field Portable MRI System Brand Name of Product: Portable Point-of-Care MRI system Manufacturer’s Name: Hyperfine Research

Model: Mark 1.5 (or newer)

4. Salient characteristics:

To satisfy the program office’s requirements, any proposed MRI system must meet the following salient physical, functional, or performance characteristics:

• Ultra-low-field (64 millitesla) MRI scanner capable of providing images of the head;

• Must be mounted on a motorized platform that can move to the head of a patient’s bed;

• Must plug into a standard 110 V wall outlet;

• Can be operated via a tablet computer;

• Can produce images capable of being seen on a clinical Picture Archiving and Communication System;

• Must weigh under 1500 lbs.

5. Maintenance service requirements:

• Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to provide preventative maintenance and service for the Portable MRI System;

• Maintenance Services shall include continued maintenance (planned and repairs), scanner software upgrades, image transfer fees, unlimited cloud storage, unlimited cloud access, and access to all cloud applications and tools starting from the date the system is delivered;

• The Contractor shall provide all necessary documentation, repair parts, spare parts, accessories, maintenance supplies, all special tools, test and support equipment, travel and transportation, personnel skill requirements, and other related services required in performance of maintenance tasks to keep the equipment in good operating condition at Original Equipment Manufacturer’s (OEM’s) specifications, except for costs of repairs occasioned by fault or negligence of the Government;

• Contractor must be an Authorized Service Provider of the Portable MRI

System. All service engineers shall have completed the required training and be certified by the manufacturer as OEM service technicians. Contractor shall utilize OEM Service Technicians and OEM Certified Parts;

• Contractor service technicians must be cleared at the NIH commercial vehicle inspection station located at 9000 Rockville Pike, Bethesda, MD to gain access to the premises;

• Contractor shall provide one (1) report at the completion of each maintenance service that documents the Portable MRI System has been serviced and is fully functioning.

6. Quantity: One system

7. Delivery Terms: The contractor shall deliver and install all equipment within 45 days after receipt of order (ARO) to 10 Center Drive, Room 5C103, MSC 1400, Bethesda, MD 20892 between the hours of 8:00 am and 5:00 pm Eastern Daylight Time (EDT), Monday through Friday. Delivery must be Freight on Board (FOB) destination, include inside delivery, and be coordinated with the Contracting Officer’s Representative (COR) prior to shipment.

The contractor shall provide an OEM-certified service technician to perform setup and installation. An OEM technician must also provide on-site training within two

(2) weeks of equipment installation.

8. Anticipated Period of Performance:

Base Period: 09/01/2020 – 08/31/2021

• Includes equipment delivery, installation, training, and one-year warranty

Option Year One: 09/01/2021 – 08/31/2022

• Includes one year of maintenance services

Option Year Two: 09/01/2022 – 08/31/2023

• Includes one year of maintenance services

Option Year Three: 09/01/2023 – 08/31/2024

• Includes one year of maintenance services

9. Option(s):

The resultant contract shall include three option years for continued maintenance (planned and repairs), scanner software upgrades, image transfer fees, unlimited cloud storage, unlimited cloud access, and access to all cloud applications and tools starting from the date the system is delivered.

The terms under which any option(s) may be exercised will be included in the contract terms and conditions.

10. Other Considerations:

Equipment must be warranted to be free from material defects in workmanship or material under normal use and service for a period of at least a one (1) year.

Contractor shall provide repairs if necessary during the warranty period and will cover all parts, labor, and associated travel costs.