SAM #RFQ-PCA-NCI-04248

NIH NIAID Procurement of Varian TrueBeam STX Radiotherapy Accelerator Replacement

The National Institutes of Health (NIH), specifically the National Institute of Allergy and Infectious Diseases (NIAID), is seeking to procure a replacement radiotherapy accelerator system for clinical use. - Government Buyer: - National Institutes of Health (NIH), NIAID - OEM Highlight: - Varian is the specified and required Original Equipment Manufacturer (OEM) - Products and Quantities: - Replacement of Varian TrueBeam STX Radiotherapy Accelerator (Cat # EDG900000004), quantity: 1 - Edge Base System HD120 MLC, EDGE v4.1, Universal Baseframe, multiple energy modes (6 MeV to 22 MeV), imaging systems, and advanced treatment delivery features - Ancillary equipment including IGRT Couch Top, PerfectPitch 6DoF Couch, power conditioner, main circuit breaker, and motion management interface - Software and licenses: TPS Eclipse licenses, RapidArc Dynamic, HyperSight Imaging Solution, HyperArc Treatment Delivery, Multi-Criteria Optimization (MCO), and associated planning modules - Implementation and training services for RapidArc, HyperArc, HyperSight, and MCO - Removal and disposal of existing TrueBeam H192104 and ancillary equipment - Trade-in discount option for existing equipment - Shipping to Bethesda, MD - Unique/Notable Requirements: - Brand name restriction to Varian for compatibility with existing NIH ARIA oncology information system and Eclipse treatment planning system - System must match the clinical and technical capabilities of the current unit and integrate with NIH hospital IT infrastructure - All FDA-mandated software/hardware updates must be included - Vendor must be FDA certified/accredited - Includes both hardware and extensive software, implementation, and training components - Utilization of existing infrastructure and support for remote diagnostics (SmartConnect Plus, Varian Data Analytics) - The procurement is for a single, highly specialized radiotherapy system with comprehensive integration and upgrade requirements.

Description

Notice Synopsis and Solicitation Details 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 dated May 22, 2024. The North American Industry Classification System (NAICS) code for this procurement is 334516 / 1000 employees – analytical laboratory instrument manufacturing. The requirement is being competed as full and open competition, with a brand name restriction. The National Institute of Allergy and Infectious Diseases (NIAID) has a requirement for: Cat # EDG900000004 - Varian TrueBeam Edge Radiotherapy Accelerator, Qty: 1 Trade-In Discount option Remove/Dispose Existing Equipment TPS Eclipse Licenses AOS Rapid arc Dynamic, Hyper Sight, and Hyperarc Implementation TrueBeam Upgrade H193045 (H193045) 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-price purchase order for a commercial product. Capability/Performance constraints: Uninstallation, removal, and disposal of existing TrueBeam, H192104, and ancillary equipment (e.g., Power Conditioner). See Statement of Need HyperSight Clinical Implementation HD120 High Definition Multileaf 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 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 containing 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 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, MD 20892 For this acquisition, the following compatibility requirements exist: Radiation energies must match existing TrueBeam STX (S/N 3045) as well as the HD120 MLC to maintain redundancy 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, cooling water connections, and electrical wiring must be utilized 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, installed in October 2014. The TrueBeam is a linear accelerator specifically made for radiotherapy of patients, typically for cancer treatment. It is the principal method of radiotherapy used in the ROB. The current TrueBeam is nearly 12 years old. Linear accelerators should be replaced periodically, typically every 7–10 years, due to age-related failure risks of components such as the klystron, waveguide, and imagers. These components are expensive to replace, often more than the cost of a new TrueBeam, and the equipment's upgrade capability is limited, preventing utilization of newer technologies. Note: The government intends to award a firm-fixed-price purchase order to the responsible contractor based on this RFQ, including the terms and conditions herein. The award will be based on the lowest price technically acceptable. By submitting a quotation, you accept that all government terms and conditions shall prevail. The technical evaluation will consider the ability to meet listed requirements and price. Applicable FAR provisions: 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 online at http://www.sam.gov/ FAR 52.203-18 Prohibition on Contracting with Entities requiring Certain Internal Confidentiality Agreements – Representation (JAN 2017) FAR 52.204-26 Covered Telecommunications Equipment or Services-Representation (OCT 2020) FAR contract clauses: 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 (Dec 2015) FAR 52.252-2 -- Clauses Incorporated by Reference (Feb 1998) These clauses are incorporated by reference with the same effect as full text. The full text is available at http://farsite.hill.af.mil/vffara.htm. By submitting an offer, the offeror acknowledges the requirement to be registered in the System for Award Management (SAM) database prior to award, during performance, and through final payment (www.sam.gov). Copies of the referenced provisions and clauses are available at http://www.acquisition.gov/far/loadmainre.html and http://www.hhs.gov/regulation/index.html. Requests can be made via telephone or fax. Submission details: Deadline: August 2nd, 2026, at 4:00 PM EST Submit offers via email to Jessica Emerson at jessica.emerson@nih.gov Include RFQ number in the subject line Late submissions will be handled per FAR 52.212-1(f) All responsible sources may submit an offer for consideration. Questions or concerns should be directed in writing via email to Jessica Emerson at jessica.emerson@nih.gov.

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