6515-- SBRT Immobilization Device
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The Department of Veterans Affairs intends to award a sole source contract to CQ Medical for the procurement of the Platinum Package (TR3000) SBRT Immobilization Device, which includes the TOTALRT Platform and associated components essential for precise patient positioning during Stereotactic Body Radiation Therapy. The device is critical for delivering high-dose radiation with minimal exposure to healthy tissue, and CQ Medical is the sole manufacturer of the TOTALRT Platform, justifying the sole source approach under RFO 6.303-2. The procurement encompasses all necessary accessories including MR Lok-Bar units, ONEBridge systems, respiratory stabilization equipment, Cushions, positioners, and support devices to ensure comprehensive immobilization and treatment reproducibility across multiple sessions. Delivery will be handled by Artivon to the Audie L. Murphy Memorial VA Hospital in Dallas, Texas, with performance slated to begin August 14, 2026, and conclude February 13, 2027. This acquisition falls under NAICS Code 339112 for Surgical and Medical Instrument Manufacturing and is restricted to U.S.-made products only. While no competitive bidding is planned, responsible parties may submit capability statements demonstrating their authorization to supply the specified equipment and their compliance with SAM registration and VIP verification for SDVOSB or VOSB status, if applicable. All submissions must be sent to Tammy Wilson at Tammy.Wilson5@va.gov no later than August 5, 2026, at 11:00 a.m. CST, and must include SAM UEI and proof of authorized distributor status. Failure to receive any affirmative responses will result in the award being granted to CQ Medical without further notice. A Contracting Officer’s Representative will be appointed post-award to oversee technical coordination, ensuring alignment with clinical and safety standards for the Radiation Oncology Service’s SRS/SBRT program, which includes physicist-led implementation, end-to-end validation, staff training, and dosimetry characterization.
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The NAICS Code for this procurement is 339112 Surgical and Medical Instrument Manufacturing which has a Small Business Size Standard of 1000 employees. This notice of intent to award a sole source contract is not a request for competitive proposals. However, in accordance with FAR 5.207 (c) (16) (ii), all responsible sources that feel they can fulfill this requirement may submit a capability statement which shall be considered by the VA. Responses to this notice shall contain sufficient information to establish the interested parties bona-fide capabilities for fulfilling the requirement, and include: SAM UEI number, along with documentation that the vendor is an authorized service provider of the equipment listed. All respondents must have an active registration in the System for Award Management at www.sam.gov. Interested Service Disabled Veteran Owned Small Businesses (SDVOSB) and Veteran Owned Small Businesses (VOSB) must be listed as verified on the Vendor Information Pages (VIP) database located at www.vip.vetbiz.va.gov/ in order to receive contract awards under the Veterans First Contracting Program. A determination by the VA not to compete this proposed action based upon responses to this notice is solely within the discretion of the VA. In addition, the information received because of this notice of intent will be retained as market research only. If no affirmative written response is received by the response date and time, a sole source contract will be awarded to CQ Medical, 440 Church Rd., Avondale, PA, 19311 without any further notice.
All interested parties must submit information directly to Tammy.Wilson5@va.gov no later than August 5, 2026 by 11:00 A.M., CST. This requirement is restricted to US made products only.
STATEMENT OF WORK North Texas Veterans Health Care System 1. SCOPE OF WORK: The North Texas Veterans Health Care System (VANTHCS) Radiation Oncology Service requires the acquisition of a Stereotactic Body Radiation Therapy (SBRT) immobilization device, specifically the TOTALRT Platform, to ensure the safe and effective treatment of patients undergoing SBRT. This advanced immobilization system is critical for achieving the precision and accuracy necessary for SBRT, which delivers high-dose radiation to tumors while minimizing exposure to surrounding healthy tissues. The TOTALRT Platform (models TR3000, TR2000, TR1000) offers comprehensive clinical setup and immobilization solutions, as highlighted in the attached image. Key features supporting this justification include: - Universal Couchtop Profile and Prodigy 2 Indexing: These ensure large, artifact-free homogeneous treatment areas for precise dose delivery, critical for SBRT's high-precision requirements. - Functional Compatibility: The platform can be extended to fit multiple devices, allowing for customized setups to improve head and neck dosimetry, which is often challenging in SBRT. - Lightweight Design: At 7.3 kg (16 lbs), the platform is CT/MR compatible, facilitating accurate imaging and treatment planning. - ONEBridge with Wide Respiratory Plate: This provides improved respiratory restriction, enhancing patient stability during treatment. - Clam-Lok Cushion: Offers additional leg immobilization, ensuring consistent patient positioning throughout the procedure. - Monarch Overhead Arm Positioner and Type-S Lok-Bar: These features provide arm positioning and reproducible indexing, essential for maintaining treatment accuracy across multiple sessions. - FlexLock Knee and Foot Supports: These customizable supports further stabilize the patient, reducing movement and improving treatment precision. - Patient Handles: These assist with secure arm positioning, enhancing patient comfort and compliance during treatment. The Platinum Package (TR3000) includes essential components such as the TOTALRT Platform, MR Lok-Bar (x4), ONEBridge (x2), ONE Storage Base (x2), ONE Respiratory Belt, Wide Respiratory Plate, ComfortCare Cushions (x3), Hand Pump, Clam-Lok Cushion (x2), Monarch Overhead Arm Positioner, Type-S Lok-Bar, T-Shape Vac-Lok, Patient Handle Set, FlexLock Knee Support, FlexLock Foot Support, FeetFix Cushion, and Overlay Stand. These components collectively ensure comprehensive immobilization and positioning, which are vital for the success of SBRT treatments. By integrating the TOTALRT Platform into our service, we can enhance treatment accuracy, improve patient safety, and achieve better clinical outcomes for SBRT patients. This equipment is essential to meet the high standards of care required in radiation oncology. Please see the attached image for a detailed overview of the platform s features and components. 2. OBJECTIVES: To enhance the precision, safety, and efficacy of Stereotactic Body Radiation Therapy (SBRT) treatments through the implementation of the TOTALRT Platform immobilization system. SECTION 1 : IMMOBILIZATION Description The primary objective of acquiring the TOTALRT Platform (models TR3000, TR2000, TR1000) is to establish a robust clinical setup for SBRT that ensures accurate patient positioning and immobilization. This system supports the delivery of high-dose radiation to tumors while minimizing exposure to surrounding healthy tissues, a cornerstone of SBRT. The TOTALRT Platform offers key features such as the Universal Couchtop Profile and Prodigy 2 Indexing for artifact-free, homogeneous treatment areas, ensuring precise dose delivery. Its lightweight (7.3 kg/16 lbs) and CT/MR-compatible design facilitates accurate imaging and treatment planning. Additionally, components like the ONEBridge with Wide Respiratory Plate, Clam-Lok Cushion, Monarch Overhead Arm Positioner, and FlexLock Knee and Foot Supports provide comprehensive immobilization, reducing patient movement and enhancing treatment reproducibility. The Platinum Package (TR3000) includes critical tools such as the MR Lok-Bar (x4), ONE Respiratory Belt, ComfortCare Cushions (x3), and T-Shape Vac-Lok, which collectively improve patient stability and comfort during SBRT procedures. By integrating this system, the Radiation Oncology Service aims to achieve consistent treatment accuracy, improve patient safety, and optimize clinical outcomes for SBRT patients. SECTION 2: CREATION OF SRS/SBRT PROGRAM Description A physicist will assist with implementing a robust SRS and SBRT clinical physics program. Site readiness assessment: o An physicist will work with the clinical team to assess the clinic s existing technical QA program, TPS beam models and clinical procedures related to SRS and SBRT services. o The intended scope of clinical SRS-SBRT services will be clarified, and initial recommendations may be provided regarding Quality Assurance (QA) and clinical workflow. TPS and machine characterization: o A physicist will review the commissioned Eclipse Treatment Planning System for possible errors or dose deviations. o physics team will characterize small-aperture dosimetry with the clinic s MLC equipped linac using appropriate small-field dosimetry systems (microchamber, GafChromic film and/or scintillator detector system). Clinical procedures and staff training: o Standard Operating Procedures for the intended scope of SRS-SBRT services and suggestions for prospective risk analysis to inform the staff training and clinical Quality Management priorities. Full End-To-End validation: o Working with the Clinical Staff, a full End-To-End process validation will be performed using an anthropomorphic head phantom. § Therapist will immobilize the head phantom per the clinic s SRS procedure and perform an SRS CT-simulation. § Contouring and MLC-based SRS treatment planning with the designated SRS planner. Plan evaluation with the SRS planner and physician. § Patient specific QA using the designated PSQA system. § Treatment setup and delivery with GafChromic film dose verification performed with therapists and physicist. Two (2) patient treatments: o Remote assistance with patient selection. o Review of treatment process from simulation to treatment 3. DESIGNATION OF CONTRACTING OFFICER S REPRESENTATIVE (COR): A Representative of the Contracting Officer (COR) will be designated to represent the Contracting Officer in furnishing technical guidance and advice under this contract. The foregoing is not to be construed as authorization to interpret or furnish advice and information to Contractor relative to the financial or legal aspects of the contract. Those matters are the responsibility of the Contracting Officer and shall not be delegated. Location: Department of Veterans Affairs Dallas VA Medical Center 4500 S. Lancaster Road Dallas, Texas 75216 Contracting Officer Representatives: Prior to contract award, the Contracting Officer shall designate a VA Medical Center employee as the COR. All work coordination shall be made through the COR. The Contractor shall be provided a copy of the letter of delegation authorizing the COR at the commencement of the term of the contract. No other person shall be authorized to act in such capacity unless appointed in writing by the Contracting Officer.
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