GenMark Dx eSensor XT8 analyzer CPT contract

Added: Jan 31, 2017 5:23 pm Statement of Work



The contractor will provide the eSensor XT8 System analyzer, two (2) analyzer modules, printer pack, and accessory kit through reagent rental purchase agreement. The contractor will provide onsite instrument installation and start-up, on-site instrument test validation, technical support and guidance, and on-site training for testing personnel. Estimated workload volumes of 2,004 Hepatitis C Genotyping Direct tests per year. The GenMark Dx eSensor XT8 analyzer will be located and testing will be performed in the Molecular Diagnostics Laboratory of P&LMS, VA North Texas Health Care System, 4500 S Lancaster Rd., Dallas, TX.



Period of performance: Base year with four (4) one year option periods





GENERAL REQUIREMENTS



1) The vendor will provide the facility with reagents, controls, disposables, and any consumable parts necessary for analyses. All components of the system must function as an in-vitro diagnostic test for HCV genotyping.



EQUIPMENT FUNCTIONALITY



1) System shall have a design that allows for preparation and analysis with minimal reagent waste.



2) System shall have a design that removes the possibility of sample carryover.



3) System shall have positive sample identification to reduce possible sources of error/delay and to improve laboratory efficiency.



INSTALLATION AND VALIDATION



The vendor provided installation/set-up including: installation/set-up, correlation studies (evaluation/comparison data sufficient to satisfy CAP standards), normal range studies, staff training, in-services to laboratory personnel and clinicians, and assisted with any methodology problems and questions. This service is available during regular office hours on a 5 days/week basis.



SERVICE AND MAINTENANCE



1) Instrument support service provides assistance with troubleshooting and repair of the analyzer. On-site service is available Monday through Friday during regular business hours (8am-5pm).



2) The vendor provides a twenty-four hour/seven-day service hotline with technical support.



3) The vendor provides a preventative maintenance schedule to include timely



scheduled vendor preventative maintenance visits as required.



4) Vendor provides standard and routine software and hardware upgrades to the equipment hardware and operating systems, without additional charge to the Government (e.g. upgrades that correct or improve either the mechanical operations or software of the system and would keep the instrument performing optimally).



5) Vendor reports no maintenance required of users



TRAINING



The vendor provided in-depth training for the use of the analyzer.