FDA Preventive maintenance-repair service for Thermo Altis-Vanquish tandem system

FDA RFQ 75F40126Q134224 This is a combined synopsis/solicitation for commercial products or commercial services prepared in accordance with the Federal Acquisition Regulation (FAR) RFO Part 12. This announcement constitutes the only solicitation. Offers are being requested, and a separate written solicitation will not be issued. The solicitation number is 75F40126Q134224. This solicitation is issued as a Request for Quote (RFQ) for a preventive maintenance and repair (PM) service agreement for a tandem system consisting of a Thermo Altis mass spectrometer and Thermo Vanquish UPLC (and subcomponents). This acquisition is not set aside for small business concerns. Any business, regardless of size, may submit a quotation. This solicitation incorporates provisions and clauses by reference. The full text of provisions and clauses may be accessed electronically at https://www.acquisition.gov/far-overhaul. The associated North American Industry Classification System (NAICS) code for this acquisition is 811210 – Electronic and Precision Equipment Repair and Maintenance, with a Small Business Size Standard of $34 million. Any business, regardless of size, may respond with a quote to this solicitation. Schedule of Supplies or Services and Prices/Costs Services shall be performed at the U.S. FDA Center for Biologics Evaluation and Research (CBER), Bldg. 52/72, Ground Floor, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002. Line Item 01 Base Period Preventive maintenance-repair (PM-R) service agreement for a Thermo Altis mass spectrometer, S/N: TSQ-A-10466; and for a Thermo Vanquish UPLC configured as follows: Vanquish model VF-P10-A binary pump, S/N: 83111990, Vanquish model VF-A10-A split sampler, S/N: 8313204; and a Vanquish model VH-C10-A column compartment H, S/N: 6503680. All services shall meet the minimum technical requirements set forth below: Quantity: 1 Unit: 12 consecutive months Annual Price: ____________________ Period of Performance (estimated): 7/15/2026 – 7/14/2027 GSA Contract Number (if applicable): ____________________________ Line Item 02 Option Year 01 Preventive maintenance-repair (PM-R) service agreement for a Thermo Altis mass spectrometer, S/N: TSQ-A-10466; and for a Thermo Vanquish UPLC configured as follows: Vanquish model VF-P10-A binary pump, S/N: 83111990, Vanquish model VF-A10-A split sampler, S/N: 8313204; and a Vanquish model VH-C10-A column compartment H, S/N: 6503680: Quantity: 1 Unit: 12 consecutive months Annual Price: ____________________ Period of Performance (estimated): 7/15/2027 – 7/14/2028 -- 1 of 15 -- GSA Contract Number (if applicable): ____________________________ Line Item 03 Option Year 02 Preventive maintenance-repair (PM-R) service agreement for a Thermo Altis mass spectrometer, S/N: TSQ-A-10466; and for a Thermo Vanquish UPLC configured as follows: Vanquish model VF-P10-A binary pump, S/N: 83111990, Vanquish model VF-A10-A split sampler, S/N: 8313204; and a Vanquish model VH-C10-A column compartment H, S/N: 6503680: Quantity: 1 Unit: 12 consecutive months Annual Price: ____________________ Period of Performance: 7/15/2028 – 7/14/2029 GSA Contract Number (if applicable): ____________________________ Line Item 04 Option Year 03 Preventive maintenance-repair (PM-R) service agreement for a Thermo Altis mass spectrometer, S/N: TSQ-A-10466; and for a Thermo Vanquish UPLC configured as follows: Vanquish model VF-P10-A binary pump, S/N: 83111990, Vanquish model VF-A10-A split sampler, S/N: 8313204; and a Vanquish model VH-C10-A column compartment H, S/N: 6503680: Quantity: 1 Unit: 12 consecutive months Annual Price: ____________________ Period of Performance: 7/15/2029 – 7/14/2030 GSA Contract Number (if applicable): ____________________________ Line Item 05 Option Year 04 Preventive maintenance-repair (PM-R) service agreement for a Thermo Altis mass spectrometer, S/N: TSQ-A-10466; and for a Thermo Vanquish UPLC configured as follows: Vanquish model VF-P10-A binary pump, S/N: 83111990, Vanquish model VF-A10-A split sampler, S/N: 8313204; and a Vanquish model VH-C10-A column compartment H, S/N: 6503680: Quantity: 1 Unit: 12 consecutive months Annual Price: ____________________ Period of Performance: 7/15/2030 – 7/14/2031 GSA Contract Number (if applicable): ____________________________ -- 2 of 15 -- Background and Requirement The U.S. Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), Division of Biological Standards and Quality Control (DBSQC) serves as a Standards Preparation facility for CBER. DBSQC maintains a well-equipped Standards preparation capacity to prepare standards for potency testing and share them with manufacturers and other regulatory agencies. Standards are used to test assay validity for products. An important part of the laboratory activities involves testing influenza vaccines for potency and identity. DBSQC performs calibration of influenza vaccine reagents. A critical assay to determine the HA content of cell grown primary standards, is isotope dilution mass spectrometry. A tandem instrument system consisting of an ultra-performance liquid chromatography (UPLC) and triple quadrupole mass spectrometer is required to perform this test – specifically, a Thermo Altis mass spectrometer, S/N: TSQ-A-10466; and a Thermo Vanquish UPLC configured as follows: Vanquish model VF-P10-A binary pump, S/N: 83111990, Vanquish model VF-A10-A split sampler, S/N: 8313204; and a Vanquish model VH-C10-A column compartment H, S/N: 6503680. This system is critical to the ongoing testing of influenza vaccines and their efficacy as it relates to the calibration of vaccine reagents. It is currently not covered under an existing service-repair agreement. This requirement is for a base period and 4 option periods of preventive maintenance-repair service. Minimum Technical Requirements are as follows for preventive maintenance and repair service for a Thermo Altis mass spectrometer, S/N: TSQ-A-10466; and …