Preventive Maintenance and Repair Services for Liquid Chromatography Mass Spectrometry System

A REQUEST FOR PROPOSAL OR SOLICITATION The U.S. Food and Drug Administration (FDA), (OAGS) is issuing this source sought announcement on behalf of Center for Biologics Evaluation and Research (CBER), in order to determine if there are existing small business sources capable of providing Post-warranty Preventive Maintenance and Repair Services on a liquid chromatography mass spectrometry (LC/MS) system. Other than small business concerns, especially vendors who may be able to offer domestic products, are also encouraged to submit a capability statement that provides company information, as well as information demonstrating that it can meet all of the minimum

requirements included below, to include the country of manufacture of products offered. If your firm is considered a small business source under North American Industry System (NAICS) Code 811210 - Electronic and Precision Equipment Repair and Maintenance; with a Small Business Size Standard of $34 million and you believe that your firm would be able to provide the FDA with the supplies/services described below, please submit an email to [email protected].

Background: The Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER) / (OVRR) has a requirement for Post-warranty Preventive Maintenance and Repair Services on a liquid chromatography mass spectrometry (LC/MS) system including a Dionex Ultimate 3000 NCS-3500RS NANO UHPLC system (SN:

8170238) interfaced to an ECLIPSE ORBITRAP ETD Mass Spectrometer (SN: FSN40119). This instrumentation is utilized by the FDA to investigate glycoconjugate based vaccine antigen structure by mass spectrometry. A post-warranty preventive maintenance and repair service agreement will allow the FDA to produce accurate experimental results, maintain continuity of operations, and protect the government’s initial investment in this piece of equipment. This requirement is for one base year and two option years. The LC/MS System is not currently covered under a service contract but is fully operational. System components: Dionex Ultimate 3000 NCS-3500RS NANO UHPLC system (SN:

8170238) ECLIPSE ORBITRAP ETD Mass Spectrometer (SN: FSN40119) Preventive Maintenance and Repair Service Minimum Performance

Requirements: The Contractor shall provide one (1) scheduled on-site planned preventive maintenance visit (including parts) per year. 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. The Maintenance and Repair activities shall be performed by service engineers who are trained and certified by the Original Equipment Manufacturer (OEM). The service provider shall follow the OEM specifications, manuals, and service bulletins, using OEM-certified replacement parts, components, subassemblies, etc. The service plan shall include access to OEM technical developments, repair procedure bulletins, and unlimited software, firmware, and application updates. The Contractor shall provide OEM -certified replacement parts. The Contractor shall include unlimited technical support (via phone and email) on software and hardware and troubleshooting with the equipment issues, Monday through Friday (excluding Federal Holidays) 8:00AM – 5:00PM Eastern Time. All maintenance/repair