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7/22/2021 - Amendment #1: The North American Industry Classification System (NAICS) code is revised from 334516 to 334519. The Product Service Code (PSC) is revised from 6640 to 6635. The U.S. Departm... 7/22/2021 - Amendment #1: The North American Industry Classification System (NAICS) code is revised from 334516 to 334519. The Product Service Code (PSC) is revised from 6640 to 6635. The U.S. Department of Health and Human Services (DHHS), National Institutes of Health (NIH), National Cancer Institute (NCI), Center for Cancer Research (CCR), Radiation Oncology Branch (ROB), requires the acquisition of two instruments – one (1) Sun Nuclear ArcCHECK 4D Isotropic Arc Delivery QA or equivalent, and two (2) Sun Nuclear Daily QA 3’s or equivalent. The required instruments will replace existing ArcCHECK and Daily QA 3 systems, which can no longer be placed under a routine maintenance agreement due to their age and will continue to provide different types of QA on radiation used for the treatment of patients. This is a combined synopsis/solicitation for commercial items, prepared in accordance with the format in FAR 12.6 as supplemented with additional information included in this notice, and shall be processed in accordance with FAR Part 13 - Simplified Acquisition Procedures. This announcement constitutes the only solicitation, and a separate written solicitation will not be issued. This solicitation, 75N91021Q00173, is issued as a request for quote (RFQ) and includes all applicable provisions and clauses in effect through FAR Federal Acquisition Circular (FAC) 2021-05 (07-12-2021), simplified acquisition procedures for commercial items. The North American Industry Classification System (NAICS) code is 334519 and the business size standard is 500 employees. 1.0 BRAND NAME OR EQUAL This requirement is for the procurement of the brand name or equivalent instruments described in section 4.0. The Federal Acquisition Regulation (FAR) provision FAR 52.211-6, Brand Name or Equal (Aug 1999) is applicable to this requirement. 2.0 BACKGROUND The U.S. Department of Health and Human Services (DHHS), National Institutes of Health (NIH), National Cancer Institute (NCI), Center for Cancer Research (CCR), Radiation Oncology Branch (ROB), requires the acquisition of two instruments – one (1) Sun Nuclear ArcCHECK 4D Isotropic Arc Delivery QA or equivalent, and two (2) Sun Nuclear Daily QA 3’s or equivalent. The required instruments will replace existing ArcCHECK and Daily QA 3 systems, which can no longer be placed under a routine maintenance agreement due to their age. The required instruments will continue to provide different types of QA on radiation used for the treatment of patients. They are necessary to ensure the accurate and safe dosage to patients, as prescribed by the physician. The ArcCHECK 4D Isotropic Arc Delivery QA is used to verify the radiation dosage received by the patient matches what the physician prescribed, as determined by the radiation treatment plan. This is required to ensure accurate patient treatment. The Daily QA 3 systems are used daily to verify that the output, energy, flatness and symmetry of radiation field are all within acceptable ranges for all modalities and energies of ROB’s Varian TrueBeam linear accelerators. This ensures that the delivered dosage matches the prescribed dose. This QA must be performed daily on the linear accelerator before it can be used to treat patients. 3.0 TYPE OF ORDER This is a Firm Fixed-Price Purchase Order. 4.0 PRODUCT FEATURES/SALIENT CHARACTERISTICS SPECIAL ORDER REQUIREMENTS: The required instruments shall be compatible with the Government-owned Varian TrueBeam linear accelerators. The following product features/characteristics are required for one (1) ArcCHECK 4D Isotropic Arc Delivery QA or equivalent. The equipment shall: Have a maximum detectable field size of no less than 21 cm x 21 cm, measured in a single pass. The field size is the area of the emitted radiation beam as if it were projected on to a flat surface perpendicular to the direction of the beam. This field size is required because the typical maximum field size in use in the ROB for external beam radiotherapy is 20 cm x 20 cm. The 0.5 cm on each side of the square on the phantom ensures that any scatter that might occur can be detected. It is important to measure any such scattered radiation, as it could result in the accidental irradiation of a patient outside the tumor volume, causing damage to healthy tissues. The single pass requirement is to prevent measurement inaccuracies that could occur from having to reposition the phantom between passes – if the phantom isn’t perfectly aligned with respect to each pass, the detected radiation would be mis-measured, resulting in an unacceptable QA test. Weigh no more than 16 kg. This is required so that the physicists be able to physically set up the phantom without assistance to perform required QA measurements. Be able to measure all photon energy modalities used for Arc Therapy: 6x, 6 FFF, 10x, 10 FFF, and 15x Have a detector array consisting of at least 1,386 diodes, each with an active detector volume of 0.64 mm3 and spaced 1.0 cm apart in a helical array, but capable of being merged into a 0.5 cm array. Have a detector sensitivity of at least 32 nC / Gy Have a detector stability of under 0.62% / kGy at 6 MV. If providing the brand name ArcCHECK 4D Isotropic Arc Delivery QA, the firmware version shall be version 1.0.0.5 or greater. Be evenly distributed throughout the entire detectable field range. This is to ensure the accurate measurement of radiation across the whole detectable field area. Meet TG-218, TG-106, TG-148 Task Group requirements. These are necessary because these set the standards by which external beam radiation is measured and quality is assessed. The ROB cannot perform patient QA tests, or do required periodic QA tests. Include patient QA software to support the operation and measurements conducted by the phantom. Such software shall be compatible with Varian’s ARIA treatment planning software currently in use by the ROB, and fully compatible with the Varian TrueBeam linear accelerator. The following product features/characteristics are required for two (2) Daily QA 3 Measurement Systems or equivalent. The equipment shall: Meet all Task Group TG-142 requirements that pertain to application of radiation for treatment only. Other requirements in TG-142 – MV/kV imaging, physical collision detection, are not applicable. Have an active chamber volume of 0.6 cm3 for electrons, and 0.3 cm3 for photons. Be able to measure the full range of electron and photon energies used by a Varian TrueBeam linear accelerator. These are required to ensure the safe and accurate application of radiation at all energy levels the Varian TrueBeam can emit. Electrons: 4 MeV to 25 MeV Photons: Co-60 (1.25 MeV) to 25 MV If providing the brand name Daily QA 3, the firmware shall be version 1.7.1 or greater. Be provided with software to analyze the measured radiation stream. Providing measurements of beam flatness, symmetry, penetration (energy) and radiation field / light field congruence. The software shall store all readings in a database for the purpose of performing trend analysis. Such software shall be compatible with Varian’s ARIA treatment planning software currently in use by the ROB, and fully compatible with the Varian TrueBeam linear accelerator. 4.1 DELIVERY Delivery shall be within 6 weeks of the Purchase Order award. The Contractor shall coordinate delivery and tracking information with the NCI Technical Point of Contact (TPOC), TBD at award, to anticipate delivery to the best extent possible. All shipping/handling (including FOB) and delivery fees shall be included in the quote. The instrument shall be delivered to the following location: 10 Center Drive Room B2-3655 Bethesda, MD, 20892 The TPOC for delivery is below: TBD at award Phone: TBD at award Email: TBD at award 4.2 WARRANTY The Contractor shall warrant that any instruments, equipment, components, or other supplies (“Supplies”) procured by this purchase are free of defects in design, material, or manufacture for a period of at least 12-months from date of acceptance. The Contractor shall warrant that all consumables or expendable parts are free of defects in design, material, or manufacture for a period of at least 90 calendar days from date of acceptance by 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. 5.0 SUBMISSION INSTRUCTIONS/EVALUATION QUESTIONS Questions must be submitted electronically via email to Contracting Officer, Adam Hernandez, at adam.hernandez@nih.gov in MS Word or Adobe Portable Document Format (PDF), no later than 2:00 PM EST, Monday, July 26, 2021 (07/26/2021). Please be advised that the Government reserves the right to transmit any questions and answers of a common interest to all prospective Contractors. QUOTATIONS Quotations must be submitted electronically via email to Contracting Officer, Adam Hernandez, at adam.hernandez@nih.gov in MS Word or Adobe Portable Document Format (PDF), no later than 2:00 PM EST, Thursday, July 29, 2021 (07/29/2021). Reference 75N91021Q00173 on all correspondence. 5.1 BASIS FOR AWARD & EVALUATION The purchase order will be awarded to the firm that submits the Lowest Price Technically Acceptable (LPTA) quotation. A technically acceptable quote is one in which the quoter(s) complies with the Statement of Need (SON) and does not take exception, nor object to any of the terms of the RFQ. Quotes that are not technically acceptable will not be considered for award. Award will be made on an all or none basis. If you are providing an “equal” product, you must submit additional documentation that highlights and describes how your offering is equal in accordance with FAR Clause 52.211-6. Evaluation and award will be conducted in accordance with the requirements of FAR 13.106. The technical evaluation will be a determination based on information furnished by the Contractor. The Government is not responsible for locating or securing any information which is not identified in the quotation. The Government intends to evaluate quotations and make a single award. Quotations should contain the quoter’s best terms from a price and technical standpoint. However, the Government reserves the right to request quote revisions that seek additional price discounts, provide revisions to the technical quote, or clarify aspects of the quote. In the event quote revisions are requested, the Government will not necessarily be seeking revisions from all quoters. The Government may reject any or all quotes if such action is in the public interest; accept other than the lowest quote; and waive informalities and minor irregularities in quotes received. 5.2 GENERAL INSTRUCTIONS This Request for Quotation (RFQ) does not commit the Government to pay any cost for preparation and submission of a quote. In addition, the Contracting Officer is the only individual who can legally commit the Government to the expenditure of public funds in connection with this proposed acquisition. By submitting a quote in response to this solicitation, it is understood that your firm’s quote shall become a part of the official contract file. The Vendor’s quote must stipulate that it is predicated upon all the terms and conditions of this RFQ and signed by an official authorized to bind your organization. In addition, it must contain a statement to the effect that it is firm for a period of at least 60 days from the date of receipt thereof by the Government. Quotes shall be submitted with a completed copy of FAR 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment, located in Section 8.0 attached to this RFQ. 5.3 Price Quote: The price quotation must contain all information necessary to allow for a comprehensive evaluation of the prices quoted. The quote must also contain the following information: a. Federal Tax Identification Number (TIN); b. Data Universal Numbering System (DUNS) Number; c. Business Size (e.g., small or large) SPECIAL DELIVERY INSTRUCTIONS DUE TO COVID-19 Due to the current COVID-19 pandemic, please pay close attention to the following delivery instructions and ensure that sufficient information is included in the quote to be considered for an award. Please be aware that due to the fluidity of the existing pandemic, instructions may be updated as needed after award. All quotes must include confirmation that equipment is or will be available for delivery by the due date indicated in Section 4.1. Quoters must confirm: Willingness to store or hold equipment until NCI is ready to accept the equipment at no additional cost. The equipment will not be sold to another company in the event NCI is not ready to accept delivery due to unanticipated changes related to COVID-19. Communicate and follow instructions from the NCI TPOC to coordinate delivery. The delivery address and TPOC’s information will be provided at time of award and must be included as part of the order/shipping label.