Preventative Maintenance/Service Contract for Seventeen (17) ChemoMetec NC-202 Instrumentsview on SAM.gov

NOTICE OF INTENT TO AWARD A SOLE SOURCE CONTRACT Title: Preventative Maintenance/Service Contract for Seventeen (17) ChemoMetec NC-202 Instruments Notice ID (POTS): 26-007432 Product Service Code (PSC): J066 – Maintenance, Repair, and Rebuilding of Instruments and Laboratory Equipment NAICS Code: 811210 – Electronic and Precision Equipment Repair and Maintenance Place of Performance: National Institutes of Health Clinical Center Bethesda, MD 20892 Notice The National Institutes of Health (NIH) Clinical Center intends to award a sole-source firm-fixed-price purchase order to ChemoMetec, Inc. for annual preventative maintenance and service support for seventeen (17) ChemoMetec NC-202 instruments used by the Center for Cellular Engineering (CCE) in FDA-regulated cell therapy manufacturing operations. Requirement The NC-202 instruments are critical analytical devices used in the manufacture and testing of patient-specific cell therapies. The contractor shall provide annual preventative maintenance, calibration, software updates and patches, inspections, troubleshooting, repair support, replacement of proprietary service parts, and technical support necessary to maintain validated operating conditions for all seventeen (17) instruments. These services are required to maintain compliance with FDA current Good Manufacturing Practice (cGMP) requirements and ensure uninterrupted patient care. The serial numbers covered under this action are as follows: 9002020042302432, 9002020042302431, 9002020042302427, 9002020042302422, 9002020042302424, 9002020042302414,9002020042302421, 9002020042302425, 9002020042302426, 9002020042302413, 9002020042302412, 9002020042302435, 9002020042302411,9002020042302436, 9002020042302434, 9002020042302423 and 9002020042302429. Sole-Source Rationale The NC-202 instruments are proprietary systems manufactured by ChemoMetec. Preventative maintenance, calibration, software updates, diagnostic testing, replacement parts, and technical support require proprietary tools, software access, and manufacturer-authorized expertise available only from ChemoMetec. Failure to use authorized maintenance services could jeopardize validated manufacturing processes, interrupt patient treatment schedules, increase regulatory risk, and require costly requalification activities. Authority The intended sole-source acquisition is authorized under FAR 13.106-1(b)(1)(i), which permits solicitation from a single source when the Contracting Officer determines that only one source is reasonably available for an acquisition not exceeding the Simplified Acquisition Threshold. Capability Statements This notice is not a request for quotations or proposals. Responsible sources that believe they can satisfy the Government's requirement may submit a written capability statement. The Government will evaluate all capability statements received; however, the determination not to compete this requirement remains solely within the Government's discretion. Submission I…