Preventive Maintenance & unlimited repair agreement for a Thermo Orbitrap Eclipse ETD-ready mass spectrometer system w/ UltiMate 3000 Nano Flow Binary RSLCNANO & Dionex WPS-3000TPL RS Autosampler   2

Background
The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS) issues this Sources Sought announcement on behalf of the Center for Biologics Evaluation and Research (CBER)’s Laboratory of Vaccine Structure within the Division of Bacterial, Parasitic and Allergenic Products in order to determine if there are existing small business sources capable of providing a Preventive Maintenance and unlimited repair agreement for a Thermo Orbitrap Eclipse ETD-ready mass spectrometer system with UltiMate 3000 Nano Flow Binary RSLCNANO and Dionex WPS-3000TPL RS Autosampler. The mass spectrometer was purchased new in Sept 2019 and was covered under a maintenance agreement until 08/22/2023; the system is not currently under a service agreement. This requirement is for a Base year plus one (1) option year.

Work Details
Minimum Performance Requirements for the Preventative Maintenance and Unlimited Corrective Repairs Service agreement: The Contractor shall provide one (1) schedule preventive maintenance (PM) visit per year which includes full system diagnostics and critical parts exchange to maintain the instrument in optimum working condition. This PM visit shall include all labor, travel, and OEM factory-certified replacement parts, components, subassemblies, etc., as well as consumables.

The Contractor shall provide unlimited on-site corrective maintenance/repairs within 3 business days of call for service where problems cannot be resolved remotely after 2 business days. Coverage must include repair of both hardware and software and must include travel and labor. The Contractor shall provide certified Original Equipment Manufacturer (OEM) parts for all repairs and maintenance. The Contractor shall provide unlimited software and firmware updates and notifications. The Contractor shall be capable of installing instrument control and data analysis software packages on new computer systems in case of computer system failures.

All Maintenance and Repair activities shall be performed following the Original Equipment Manufacturer (OEM) specifications, manuals, and service bulletins, using OEM-certified replacement parts, components, subassemblies, etc. Service contract coverage shall include troubleshooting capabilities based on complete knowledge of the entire instrument, immediate access to certified replacement parts, and immediate access to improvements and new procedures provided by the original vendor and manufacturer. The service/maintenance activities shall be performed by formally trained and OEM-certified technicians/engineers who have experience servicing this instrument. Engineers shall have access to the manufacturer’s latest technical developments, repair procedures, application updates, diagnostic software, and planned maintenance procedures.

Services shall be performed following Original Equipment Manufacturer (OEM) specifications, manuals, and service bulletins, using OEM replacement parts, components, subassemblies, etc. The Contractor shall include unlimited technical support Monday through Friday (excluding Federal Holidays) 8:00AM – 5:00PM Central Time. The contract shall enable the FDA Technical Point of Contact (TPOC) and system operator personnel to have access to the manufacturer's call center for technical assistance, which is staffed by senior engineers to provide a high level of expertise for troubleshooting the instrument.

Period of Performance
Anticipated to be a Base plus two (2) Option Years with the following period of performance dates: Base Year: 07/14/2023 – 07/13/2024 Option Year 1: 07/14/2024 – 07/13/2025 Option Year 2: 07/14/2025 – 07/13/2026

Place of Performance
The equipment is located at US FDA/CBER, 10903 New Hampshire Ave., Building 52/72, Room G430, Silver Spring, MD 20993