Preventive Maintenance, Emergency Service, Support, and Coverage for a Government-Owned Illumina Micro-array Scanner with iScan and RoMa Serviceable Components

The firm-fixed-price contract action was not awarded competitively. UNIQUE QUALIFICATIONS OF THE CONTRACTOR The Government-owned Illumina Micro-array Scanner with iScan (S/N N0948) & RoMa (S/N 1803000025) components is critical to clinical testing and patient treatment and therefore any malfunctions with the equipment must be diagnosed and corrected quickly. The equipment must be calibrated accurately and maintained according to the manufacturer’s specifications by authorized Original Equipment Manufacturer (OEM) trained service engineers. Service outage due to equipment failure must be remedied promptly with emergency service to avoid harmful delays to patient treatment schedules. Any deviation from the design specifications could result in patient harm and compromise the integrity of data for ongoing clinical and research studies. Preventive maintenance is required to maintain laboratory accreditation with Clinical Laboratory Improvement Amendments (CLIA) and College of American Pathologists (CAP) and necessary to provide the highest standard of performance for complex clinical and scientific instruments used for clinical testing. Illumina, Inc. is the original manufacturer, distributor and service provider for the iScan microarray reader. The RoMa liquid handler is an instrument manufactured by TECAN and customized by Illumina by installing exclusive firmware and software for performing Infinium assays. There are no other vendors that have access to the proprietary firmware and software configuration of RoMa. The current software and hardware set-up for iScan and RoMa components and their performances were validated by the Laboratory of Pathology of CCR, NCI for the clinical testing of patient materials. Any changes in the analytical performance of the above instruments will require extensive re-validation of the assay by the laboratory which may change concordance with previous results obtained during testing of patient material and may delay clinical testing. Therefore, it is critical that the preventive maintenance and service of the iScan and RoMa instruments and their components are performed by qualified technical personnel. Illumina, Inc. is the sole provider of preventive maintenance service, emergency service, proprietary firmware maintenance/upgrades, genuine OEM replacement parts, and OEM-trained technical and clinical support for troubleshooting and diagnosing issues that arise during regular operation of the iScan and Roma systems. The required services are not authorized through any other entity.