B08_SOL_Attachment_1_SOW.pdf

STATEMENT OF WORK (SOW)

1.0 TITLE

National Cancer Institute (NCI) Radiation Oncology Branch (ROB) Acquisition of Magnetic Resonance (MR) Linac System for Radiation Therapy

2.0 BACKGROUND

This equipment is mission-critical to patient treatment in ROB. Many patients require scans using MR Imaging, as it provides information to the physician not available using other imaging modalities such as Computed Tomography (CT) or standard x-ray imaging. In addition to providing high-resolution visualization of soft tissue based on hydrogen content, rather than electron density; MR imaging can also be utilized for functional imaging by administering select contrast agents to provide information on the biology of tissues. This requires an MRI unit with a magnetic field strength of at least 1.5 Tesla.

NCI requires an integrated MR Linear Accelerator System for precise, concurrent imaging and treatment of cancer patients. This requirement consists of a 1.5 Tesla MR Imaging Scanner with an integrated digital linear accelerator generating a 7 MV photon beam coupled with state-of-the-art 160 leaf multi-leaf collimator (MLC), all within a fixed reference coordinate system; so that the images are directly mapped to the radiation treatment plan. This requirement includes an on-line adaptive planning system; including a server and treatment planning/ review workstation.

MRI units require specialized magnetic and radiofrequency (RF) shielding. This acquisition covers the necessary site planning and all installation necessary to make the unit functional. This acquisition includes the demolition and construction costs associated with transporting the system from the loading dock to the selected treatment room due to the size of the magnet, as well as the associated construction costs for installing the system, electronic operators console and the required MR compatible dosimetry and Quality Assurance devices which are critical to the clinical operation.

3.0 OBJECTIVES

The ROB of the CCR, NCI requests to purchase a linear accelerator with unique capabilities. This required system combines a 1.5 Tesla Magnetic Resonance Imager (MRI) with a 7 Megavolt linear accelerator equipped with a 160 leaf multi-leaf collimator in order to treat select patient groups with a higher degree of accuracy by utilizing the benefits of MR imaging to provide increased target delineation while maintaining a consistent internal geometric coordinate system necessary for eliminating inaccuracies inherent in moving a patient from one system (imaging) and repositioning them on a second system for treatment.

4.0 TECHNICAL REQUIREMENTS

4.1 PRODUCT FEATURES/SALIENT CHARACTERISTICS

The system to be acquired shall meet the following requirements:

The Government requires a commercial, fully integrated MR-guided linear accelerator system and associated installation services meeting the following minimum salient characteristics

5.0 7 Megavoltage (MV) photon beam

6.0 160 Multileaf Collimator (MLC)

7.0 Onboard 1.5T (or greater) MR imaging system: including

7.1 Imaging protocols explicitly created for MR-guided external beam radiotherapy, including Diffusion Weighted Imaging (DWI) and imaging and treating in the presence of patient motion (body and/or anatomical motion)

7.2 MR receive coil with low attenuation of the radiation beam

7.3 Dedicated MRI console for imaging guidance and control

8.0 Patient positioning system, consisting of:

8.1 Flat table with comfort mattress for patient restraint and comfort

8.2 Indexable table for repeatable patient setup between treatment fractions

9.0 Quality Assurance (QA) capabilities:

9.1 MV alignment phantom

9.2 MR to MV alignment phantom

9.3 MR head phantom

9.4 3D Geometric phantom

9.5 Supporting software for the above

10.0 Treatment room accommodations for patient comfort and safety, including:

10.1 Adjustable lighting

10.2 Patient alignment laser system

10.3 CCTV and intercom

11.0 Site planning, shielding/integration support, delivery, installation, commissioning, training, and warranty

4.2 TRAINING

Within XX business days after installation, XX day(s) of onsite training shall be provided for at least XX user(s) of the equipment on how to use and maintain the instrument and associated software. All training expenses, including materials and/or travel expenses, shall be included.

5.0 DELIVERY / INSTALLATION

Delivery shall be within XX business days of purchase order award. All shipping/handling (including F.O.B. Destination) and delivery/installation fees shall be included. Upon shipment, the Contractor shall email the NCI Technical Point of Contact (TPOC) with a shipping tracking number. Upon delivery, the Contractor shall notify the NCI TPOC to schedule the installation date and time.

Installation shall occur within XX business days of delivery, and shall be performed, or under the direct supervision of, an Original Equipment Manufacturer (OEM) certified technician. Equipment shall be delivered and installed to the following address:

10 Center Drive, CRC/B2-3661 Bethesda, MD 20892-1682

7.2 CONTRACTING OFFICERS REPRESENTATIVE OR TECHNICAL POINT OF CONTACT

All work delivered to the Contracting Officers Representative (COR) or Technical Point of Contact (TPOC) will be deemed to have been accepted upon written confirmation of acceptance by the COR/TPOC. The COR/TPOC’s approval or revision to the work delivered shall be within the general scope of work for the Purchase Order.

The following individual shall be the COR/TPOC for this task order:

COR/TPOC Name: Robert Miller Branch Name, NCI, NIH Email: rwmiller@mail.nih.gov Phone Number: 301-728-8274 Street, Building, Room: MSC 1682 10 Center Dr, CRC/B2-3661 City, State, Zip code: Bethesda, MD 20892-1682

Performance of work under this Contract must be subject to the technical direction of the COR/TPOC identified above. The term "technical direction" includes direction to the Contractor that fills in details and otherwise serves to ensure that tasks outlined in this requirements document are accomplished satisfactorily. Technical direction must be within the scope of this requirements document.

The COR/TPOC does not have authority to issue technical direction that:

a. Constitutes a change of assignment or additional work outside of this requirements document

b. Constitutes a change as defined in the clause 52.212-4 (c) governing "Changes";

c. In any manner causes an increase or decrease in the contract price, or the time required for contract performance;

d. Changes any of the terms, conditions, or requirements of the contract;

e. Interferes with the Contractor's right to perform under the terms and conditions of the contract; or

f. Directs, supervises, or otherwise controls the actions of the Contractor's employees.

Technical direction may be oral or in writing. The COR/TPOC shall confirm oral direction in writing within five business days, with a copy to the Contracting Officer. The Contractor shall proceed promptly with performance resulting from the technical direction issued by the COR/TPOC. If, in the opinion of the Contractor, any direction of the COR/TPOC, or their designee, falls within the limitations in (b), above, the Contractor shall immediately notify the Contracting Officer no later than the beginning of the next Government business day.

Failure of the Contractor and the Contracting Officer to agree that technical direction is within the scope of the contract shall be subject to the terms of the clause 52.212-4 (d) titled "Disputes."

8.0 WARRANTY

The Contractor shall warrant all supplies furnished under this award against any defects in design, material, or manufacture for a period of at least 12-months from date of installation. The Contractor shall also warrant and imply that all items delivered as a result of this order are merchantable and fit for use for the particular purpose described in the order in accordance with FAR 52.212-4(o).

If a defect results in lost or decreased performance of supplies or services furnished under this order, the Contractor shall cover all parts, materials, labor, and/or travel expenses required to repair or replace the supplies at no cost to the Government.

Supplies which are repaired or replaced shall be warranted for the remainder of the initial warranty period or for 90-days – whichever is greater.