Replacement of TrueBeam STX H192104

This notice is a combined synopsis/solicitation for commercial items using Simplified Acquisition Procedures. This acquisition will be made in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6 “Streamlined Procedures for Evaluation and solicitation for commercial Items,” as applicable, and as supplemented with additional information included in this notice. This announcement constitutes the only solicitation (a written solicitation will not be issued) and quotes are being requested. The Solicitation number is RFQ-PCA-NCI-04248 and the solicitation is issued as a Request for Quotes (RFQ).

This acquisition will be processed under FAR Part 13 Simplified Acquisition Procedures (SAP). The solicitation documents and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) FAC 2024-05 May 22, 2024

The North American Industry Classification System (NAICS) code for this procurement is 334516 / 1000 employees – analytical laboratory instrument mfg. The requirement is being competed full and open competition, brand name restriction.

The National Institute of Allergy and Infectious Diseases (NIAID) has a requirement for:

1. Cat # EDG900000004 - Varian TrueBeam Edge Radiotherapy Accelerator Qty: 1

2. Trade-In Discount option

3. Remove/Dispose Existing Equipment

4. TPS Eclipse Licenses

5. AOS Rapid arc Dynamic, Hyper Sight, and Hyperarc Implementation

6. TrueBeam Upgrade H193045 (H193045)

7. Shipping to 10 Center Dr, Bethesda, MD 20892 (FOB DESTINATION)

The following product features/characteristics are required for this requirement: The new TrueBeam must have the same capabilities and configurations as the one it is to replace. Its performance is to match the other TrueBeam in the ROB, H193045. There are currently no known cost constraints. It is anticipated that the award will be for a firm-fixed-priced purchase order for a commercial product.

• Capability/Performance constraints:

• Uninstallation, removal, and disposing of existing TrueBeam, H192104 and ancillary equipment (eg. Power Conditioner).

• See Statement of Need

• HyperSight Clinical Implementation

• HD120 High Definition Mulitleaf Collimator with dual independent jaws

• X-Ray treatment delivery technique package, including 6MMV 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

• MV imager for radiographic, cine, and integrated imaging including 2D/2D Radiographic Image Review and match

• RTI kV imager, with a 40cm x 30cm 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

• 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

• Fraction number displayed on in-room monitor

• Online access to a marketing kit that contains a broad range of advertising, educational, promotional, and public relations materials targeted to referring physicians, patients, and the media

• Compatible with ARIA oncology information system for radiation oncology v15.1 through v17.0, or ARIA OIS v18.0 or higher, or compatible third-party oncology information system

• Compatible with Eclipse treatment planning system v15.1 or higher, or compatible third-party treatment planning system

• All FDA mandated IT software/hardware updates must be provided.

• The functionality of all existing interfaces between the Varian TrueBeam system and the NIH Hospital Information System that were originally created by the OEM for the Government must be maintained.

• The remote monitoring system must be done via HL7 approved secure connection to fulfill IT security requirements (through SSL-VPN-TLS, see compatibility requirements above).

• The vendor must be certified and/or be accredited by the FDA, as proof of adequate up-to-date OEM factory training of its field engineers and the use of parts that meet the original specifications.

• Shipping location:

NIH

10 Center Dr

Bethesda, MT 20892

For this acquisition, the following compatibility requirements exist at this time:

• Radiation energies must match existing TrueBeam STX (S/N 3045) as well as the HD120 MLC in order to maintain redundancy necessary for uninterrupted patient treatments.

• The remote monitoring system must be compatible with the NIH Active Directory structure for login purposes.

• The remote monitoring system must utilize the pre-existing, secure SSL-VPN-TLS connection.

• Existing accelerator base frame must be utilized; as well as existing cooling water connections and electrical wiring

• All interfaces between the Varian TrueBeam system and the NIH Hospital Information System must remain fully compatible.

• Position of radiation isocenter must be maintained

Brand name justification: 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.

• The government intends to award a firm fixed price purchase order to the contractor responsible as a result of this RFQ that will include the terms and conditions set forth herein. The award will be based the lowest price technically acceptable. By submitting a quotation, you are accepting that all government terms and conditions set forth herein shall prevail over the award. The technical evaluation will be based on the following: technical capability to meet the requirements listed on the attachment, and then price.

The following FAR provisions apply to this acquisition:\

FAR 52.212-1 Instructions to Offerors Commercial Items (SEP 2023)

FAR 52.212-3 Offerors Representations and Certifications - Commercial Items (Feb 2024)

FAR 52.204-7 System for Award Management (OCT 2018)

(Offerors must complete annual representations and certifications on-line at http://www.sam.gov/ in accordance with FAR 52.212-3 Offerors Representations and Certifications- Commercial Items (Please ensure FAR 52.209-2 -- Prohibition on Contracting with Inverted Domestic Corporations--Representation. (Nov 2015) is updated in your SAM record)

FAR 52.203-18 Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements – Representation (JAN 2017)

52.204–26 Covered Telecommunications Equipment or Services-Representation

(OCT 2020) *** Must complete representation if attached to this solicitation- see attachment 52.204-26

The following FAR contract clauses apply to this acquisition:

FAR 52-212-4 Contract Terms and Conditions Commercial Items (NOV 2022)

FAR 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (MAR 2023)

FAR 52.204-13 System for Award Management Maintenance (OCT 2018)

FAR 52.204-25 Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment (NOV 2021)

HHSAR 352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (December 2015)

FAR 52.252-2 -- Clauses Incorporated by Reference. (Feb 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also,

the full text of a clause may be accessed electronically at this address:

http://farsite.hill.af.mil/vffara.htm

By submission of an offer, the offeror acknowledges the requirement that a prospective awardee shall be registered in the System for Award Management (SAM) database prior to award, during performance, and through final payment of any contract, basic agreement, basic ordering agreement, or blanket purchasing agreement resulting from this solicitation (www.sam.gov).

Copies of the above-referenced provisions and clauses are available from http://www.acquisition.gov/far/loadmainre.html & http: //www.hhs.gov/regulation/index.html or, upon request, either by telephone or fax.

Submission shall be received not later than August 2nd, 2026 @ 4:00 PM EST

Offers may be e-mailed to Jessica Emerson (E-Mail/ jessica.emerson@nih.gov). Offers shall include RFQ number in the subject line (RFQ-PCA-NCI-04248). Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f)

All responsible sources may submit an offer that will be considered by this Agency.

Any questions or concerns regarding this solicitation should be forwarded in writing via e-mail to Jessica Emerson at jessica.emerson@nih.gov