New TrueBeam - SON.docx

STATEMENT OF NEED (SON)

1.0 TITLE

Replacement of TrueBeam STX H192104

2.0 BACKGROUND

The Radiation Oncology Branch (HHS/NIH/NCI/CCR/ROB) purchased the Varian TrueBeam (H192104) in 2014, and it was installed in October, 2014. The TrueBeam is a linear accelerator made specifically for the radiotherapy of patients, typically for the treatment of cancer. It is the principal method of radiotherapy used in the ROB.

The current TrueBeam is close to 12 years in age. Linear accelerators should be replaced periodically, typically every 7 – 10 years. This is principally due to age of some of the major subsystems in the accelerator. Components such as the klystron, the waveguide, and the imagers are at risk of age-related failure. These are expensive to replace, collectively likely more expensive than a new TrueBeam. Additionally, like all equipment, it is limited in its upgrade capability, and so could not take advantage of newer technologies as they are developed.

3.0 OBJECTIVES

The objective of this acquisition is to is to obtain a replacement linear accelerator. It must be capable of everything the TrueBeam has, including energy levels, able to be closely integrated with Aria (the radiation treatment planning software in use at the ROB), ability for remote diagnostics such SmartConnect Plus and Varian Data Analytics (ViDA), imaging, etc.

4.0 TECHNICAL REQUIREMENTS

4.1 PRODUCT FEATURES/SALIENT CHARACTERISTICS

The following product features/characteristics are required for this requirement:

· Fine definition Multileaf Collimator (MLC) with dual independent jaws

· CCTV camera system for room monitoring during treatments

· Basic X-Ray treatment delivery technique package, including 6MV X-ray treatment energy, Static Photon, Photon Arc, and Dynamic Conformal Arc treatment delivery techniques

· Intensity Modulated Radiotherapy (IMRT) treatment technique, including large field IMRT

· Total Body Treatment technique package

· Mega Voltage (MV) imager for radiographic, cine, and integrated imaging including 2D/2D image review and match

· Kilo Voltage (kV) imager, with a 40cmx30cm active imaging area

· Matching of 2D radiographs to 3D reference images

· Online addition of kV and MV imaging protocols to treatment fields, with automated generation of reference images

· Online physician approval of images at treatment console (compatible with ARIA only)

· Relative portal dosimetry image and integrated image acquisition capability

· Front pointer set and drum phantom for Machine Performance Check (MPC)

· Custom DRR templates that are created in Eclipse will be available on the TrueBeam Platform

· Electronic Dynamic Wedges (EDW)

· Image only sessions

· Unplanned Treatment Mode up to 5 fractions

· Automated Machine Performance Check Testing, Online Machine Performance Check Review

· Offline Machine Performance Check Review

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.

4.3 SPECIAL ORDER REQUIREMENTS

This section should provide any unusual or special contractual requirements. For example, the SON shall specify separately the work requirements to Information Security or EIT 508 Compliance. Other examples include requirements for the Contractor to execute external agreements, such as, Material Transfer Agreements, Data Use Agreements, Data Transfer Agreement, Data Sharing Plans, Service Level Agreements, etc.

5.0 TYPE OF ORDER

A Firm-Fixed-Price (FFP) contract provides for a price that is not subject to any adjustment on the basis of the contractor’s cost experience in performing the contract. FFP contracts may be structured to include additional optional periods of performance (up to 5 years) or optional quantities for additional products (not more than 50 percent of the initial quantity).

Contracts intended to be on a reimbursable bases, including Time and Materials (T&M) or Labor Hour contracts shall not use this SON template.

This is a Firm Fixed-Price Purchase Order.

6.0 PRICE SCHEDULE

For equipment, complete this section if the Government’s intent is to purchase the equipment outright. For all other payment arrangements (Lease, Installment Payments, etc.), STOP and contact the Office of Acquisitions.

The total fixed price of this contract is $_____.

Upon delivery and acceptance of the item(s) described in SECTION 4.0 of this contract and identified in the schedule of charges below, the Government shall pay to the Contractor the unit price(s) set forth below:

SCHDULE OF THE CHARGES FOR THE BASIC AWARD PERIOD

*Unit Price and Total may be marked TBD

7.0 DELIVERY / INSTALLATION

To avoid violations of the Bona-Fide-Needs rule and Appropriation Law, equipment that requires facility renovation prior to installation shall not be order until the renovation is complete. If you have concerns with this instruction, please discuss with the Office of Acquisitions Contracting Officer.

Insert all applicable information for delivery (e.g. delivery address, Govt TPOC name and phone number and delivery timeframe). If needed, require a shipping tracking number to be provided to the TPOC. Proposed language below. Please complete the highlighted sections or edit as needed.

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) 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 super vision of, an Original Equipment Manufacturer (OEM) certified technician. Equipment shall be delivered and installed to the following address:

7.2 CONTRACTING OFFICERS REPRESENTATIVE OR TECHNICAL POINT OF CONTACT

For Firm Fixed Price orders that do not exceed $250,000 designate a TPOC. For Firm Fixed Price orders over $250,000 designate a certified FAC-COR. See: https://oalm.od.nih.gov/initialFACCOR

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 Branch Name, NCI, NIH Email Phone Number Street, Building, Room City, State, Zip code Performance of work under this Purchase Order 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:

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

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

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

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

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

1. 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.