Description
BACKGROUND INFORMATION The Food and Drug Administration - Denver Laboratory is responsible for the analysis of a wide variety of food additives and chemotherapeutic agents. Among our responsibilities is the analysis of antibiotic and veterinary drug residues in seafood, game meats, milk, as well as other food and feed samples. These types of samples usually equate to approximately 500-600 samples per year. The samples require analysis of compounds which carry either a positive or negative charge, thus necessitating an instrument that can run in positive and negative mode. One of the Sciex 5500 MS instruments in the Antibiotics section of the Denver Laboratory currently has a front end ion source that does not maintain a stable connection when using APCI mode which adversely affects our ability to run in negative mode. It is necessary to replace the front end ion source of this instrument to bring the instrument back into operational parameters to accommodate sample volume and ensure the analysis of samples in a timely manner to meet reporting timeframes. OBJECTIVES The objective for this work request is to provide an ion source for a Sciex 5500 MS instrument necessary for the continued use of the analytical method described in LIB 4562 for regulatory samples. This purchase will replace and upgrade a similar, aging ion source, that is no longer functioning at a level congruous with our needs. SCOPE The Contractor shall provide a new Ion Source meeting the specifications below, with the following additional required components: Orifice Plate for the Sciex 5500 Front Door Panel for the Exion AC MINIMUM REQUIRED PERFORMANCE SPECIFICATIONS Minimum Required Performance Specifications Must be able to be used for either electrospray ionization (ESI) or atmospheric pressure chemical ionization (APCI). Must be compatible with an Sciex 5500 MS hardware system and components. Must be compatible with both the TurboIonSpray® probe and APCI probe manufactured by Sciex. Must be compatible with and be able to operate under Sciex software. Trade and Service Specifications The instrument must be a newly manufactured unit, not used and refurbished or previously used for demonstration. FOB Point destination to include lift-gate, inside delivery and clean-up of area after installation. The entire system must be warranted for parts and labor for 12 months from the date of formal government acceptance. The vendor must also be capable of servicing the instrument through the covered warranty period. The system must include at least a one (1) year warranty and shall include at a minimum: coverage on all non-consumable items and parts supplied including base instrument, factory-certified replacement parts, engineer labor and travel costs. Any equipment repair and maintenance work shall be performed by an OEM-trained engineer. This factory-trained engineer shall have (verified by the OEM) the following: 1) access to OEM factory telephone support; 2) access to the most current OEM factory training for both hardware and software components; and 3) access to all current OEM factory parts, not build-to-order parts. The OEM-trained service engineer shall not use salvaged parts from other instruments for performing maintenance and repairs. All parts used in PM and repairs must be guaranteed, factory-tested, OEM quality parts. Instrument operators shall have access to a technical representative call center at no additional charge, for technical assistance and trouble-shooting, which is staffed by senior engineers to provide a high level of expertise for troubleshooting the instrument. The Contractor shall provide instrument installation with an employee who can verify instrument performance. Records and Reports The Contractor shall, commensurate with the completion of each service call relating to the first year warranty, provide the end-user of the equipment with a copy of the field corrective service report identifying the equipment name, manufacturer, model number, and serial number of the equipment being repaired and detailing the reason for the warranty call, a detailed description of the work performed. The parts and the test equipment used to repair the system shall be on the report. This will include the name (s) and contact information of the engineer who performed the repair, and for information purposes, the on-site hours expended, and parts/components replaced. Deliverables Deliverable Quantity Delivery Date Deliverable Quantity Delivery Date Ion Source 1 Within 60 days of award Installation 1 Within 30 days of delivery Confirmation of instrument performance as used in Denver Laboratory 1 Concurrent with install Corrective action to fix the system under any failures during warranty Within 15 days of request for service due to any inoperability of the system Field Service Report Upon installation and completion of each repair Security/Privacy Requirements/Risk Assessment Safety precautions will be taken prior to and during installation. Contractor will be cleared by security as a visitor upon arrival to Denver Federal Center Building 20. Coordinator must inform contractor of this process before their arrival. Covid-19 precautions- Special precautions must be taken to ensure safety of building residents and contractor regarding Covid-19 as specified in local guidance. Contractor will contact the local TPOC listed herein for specifics to arrival. Section 2 of FDA Security and Privacy Language does not apply.