iCAP-TQ additional gas module (Toxic Elements)

RFQ no. 75F40126Q00301 STATEMENT OF WORK Gas module for an existing Inductively Coupled Plasma Mass Spectrometer (ICP-MS - ThermoFisher iCAP TQ) 1. Purpose The Office of Chemistry and Toxicology (OCT), Division of Bioanalytical Chemistry (DBC), Chemical Contaminants Branch (CCB) requires the purchase of a gas module to be coupled to an existing mass spectrometer to be used to measure toxic and nutritional elements in foods and dietary supplements. 2. Background The Chemical Contaminants Branch within the Office of Chemistry and Toxicology, Division of Bioanalytical Chemistry requires the purchase of a gas module for an existing instrument. The equipment requested will be used for the following applications: 1. Measuring toxic elements in foods and dietary supplements 2. Measuring elemental concentrations in foods with higher concentration of total dissolved solids (TDS) 3. Reducing matrix effects in highly concentrated samples and in samples with higher carbon content 4. Reducing the need for dilutions to measure nutrient elements that are typically present in high levels (>1000 ppm - percent levels) in the foods 5. Maintaining acceptable stability throughout an entire analytical sequence This instrument offers accurate, cost-effective benefits for mass spectrometric analysis and will ensure accuracy and stability. Additionally, this gas module will save time and resources otherwise wasted preparing additional dilutions of the samples. Upon installation of the gas module, the argon gas dilution capability for the iCAP TQ will enable the analysis of high matrix samples by diluting the nebulized sample stream, decreasing the sample load, and enabling tolerance of the direct analysis of a higher level of matrix compared to standard operating conditions. These applications are critical to the FDA’s mission to ensure the safety of the nation’s food supply and its proper and accurate labeling. 3. Objectives The purchase of this gas module is necessary to support several applications that are critical to the FDA’s mission. The major components of the acquisition plan shall have: • Minimum requirements: o Gas Module for iCAP Triple Quadrupole  1000 mL/min mass flow controller  Tubing and connectors for the additional gas port o Installation and performance check of the gas module using the existing instrumentation (i.e., Thermo Fisher iCAP TQ), as well as any necessary software modifications to tune using the dilution gas -- 1 of 12 -- 4. Technical Specifications 4.1. Technical Specifications • Item: Gas Module for iCAP Triple Quadrupole • Main component: 1000 mL/min mass flow controller • Additional components: Y-connector to split the original argon line, any other tubing and connectors necessary • Software compatibility: Adjustments to the Configurator software to reflect the new gas in Qtegra (the ICP-MS main software) 4.2. Performance Specifications • Tuning requirements: The gas module shall pass tuning requirements using the auto-tune feature using the dilution gas 5. Delivery The vendor shall be responsible for delivery of the instrument and all components specified above to the FDA/HFP laboratory facility located at 5001 Campus Drive, College Park, MD 20740. The delivery shall be made to the loading dock and moved into location on the date of installation. 6. Installation and Set-up The vendor shall be responsible for installation and set-up, including initial calibrations. 7. Training and Documentation Installation shall include onsite training led by the contractor personnel on the day of the installation to make sure the user is familiar with how to use the system, and aware of any maintenance or troubleshooting of the module. 8. Warranty and Maintenance The instrument shall l be covered by a one (1) year warranty from the date of installation. The warranty shall cover all parts and labor with one preventative maintenance. 9. Inspection and Acceptance The instrument shall not be accepted until performance specifications have been met. The FDA project officer will perform inspection and acceptance of the instrument. The entire system shall be warranted for parts and labor for twelve (12) months from date of installation. Service shall be provided by service engineers who are trained and certified by the original manufacturer of the instrument. Engineers shall have access to the manufacturer’s latest technical developments, repair procedures, application updates, diagnostic software, and planned maintenance procedures. 10. Quality Assurance The system shall be a newly manufactured unit, not used or refurbished, or previously used for demonstration. The instrument shall meet all the technical requirements specified above in Section 3. (“Objectives”) and Section 4 (“Technical Specifications”) of this Request for Quote (RFQ). -- 2 of 12 -- 11. Security Requirements Not Applicable 12. Environmental Considerations Not Applicable 13. Government-Furnished Property, Material, Equipment, or Information (GFP, GFM, GFE, or GFI) Not applicable 14. Travel All travel charges will be in accordance with the Federal Travel Regulation. For additional reference, the contractor shall refer to the Federal Travel Regulation: https://www.gsa.gov/policy- regulations/regulations/federal-travel-regulation. 15. Contractor Provided Special Material Requirements Not Applicable 16. Place of Performance The vendor shall be responsible for delivery of the instrument and all components specified above to FDA/HFP laboratory facility. FDA/HFP, 5001 Campus Drive, College Park, Maryland, 20740. Delivery and installation should be coordinated through the HFP Project Officer. Work shall be conducted Monday through Friday, excluding federal holidays. 17. Period of Performance (POP) The POP is anticipated to be twelve (12) months. September 30, 2026 to September 29, 2027 18. Points of Contact Contracts Specialist (CS) Nam Nguyen Nam.Nguyen@fda.hhs.gov Contracting Officer (CO) Maeve Xavier Maeve.X…