DESCRIPTION OF SERVICES.

•·         Installation: Placement and installation of the Microbiology Analyzer and all equipment components inclusive, but not limited to, all laboratory associated mechanical, electromechanical parts, additional items (ie. Table(s) for validation), and supplies. Installation shall conform to Industry Standards and shall meet or exceed all applicable codes to include Local/State Regulations, National Fire Protection Agency (NFPA), building codes, communication codes, and other codes for each utility identified.

•·         The contractor shall provide a Project Manager to oversee system installation and required technician to perform correlation and validation. The contractor shall provide all validation reagent/materials needed to perform these tasks.  The contractor shall have electrician and engineering specialists on site when the Microbiology Analyzer is delivered for proper equipment installation.

•·         The contractor shall provide an Uninterrupted Power Supply (UPS) per analyzer required for emergency use which must be installed in the appropriate location as determined by the MTF.  This UPS is a self-operated unit that provides enough power, during a commercial power outage, to ensure the Microbiology Analyzer system remains operational.  The overall approximate measurement of the analyzer is below:

•o    Dimensions: 29" H x 38.5" W x 34" D

•o    Weight:  376 lbs

•·         The contractor shall complete clean-up (upon installation) of the work area and disposal of debris, to include any need for cosmetic repairs on walls, floorings, ceiling, etc.

•·         The contractor is responsible for the removal of the analyzer at the end of the contract period or at the government's discretion.

Analyzer:

•·         The contractor shall provide an analyzer that meets the requirements stated in Appendix A, the performance characteristics for accuracy and precision as well as compatible with the Hospital Information System (HIS)/Laboratory Information System (LIS).  The analyzer shall meet the following criteria:

•·         Analyzer and assays:  Analyzer and assays shall be FDA approved (the contractor must provide proof of certification). The assay, analyzer, or company (contractor) cannot have FDA warning letters issued over the past 24 months.

•·         Have function as an automated, walk-away analyzer for microbiological samples, by testing automating test processing functions including automatic incubation, test interpretation, continuous reagent monitoring, and external LED indicators to show reagent levels. 

•·         The system must use a digital bar code technology to read labeled sample panels.

•·         The system can run combination panels that includes identification and antimicrobial sensitivities on the same panel.

•·         The system must provide critical process monitoring and management of system maintenance and quality control (QC) by verifying, documenting, and resolving diagnostic checks throughout sample processing.

•·         The system provides onboard reagent tracking to monitor lot numbers, expiration dates and volumes. To include external LED indicators to show reagent levels.

•·         The system provides on board documentation of quality control (QC) results

•·         Ability to use only one printer to print and evaluate QC/patient data, review screens, or print files while analyzing patient samples. 

•·         Ability to review abnormal results on the analyzer. 

•·         Information Management System must be able to provide:

•·         Downloading of multiple orders and send QC orders that specify the panel(s) to use as well as the expected results.

•·         Entry of control data from diskette or USB ports

•·         Bi-directional transmission of patient results and control results to a host computer.

•·         Must be able to manage identification and antibiotic susceptibility testing from laboratory workstation

•·         Ability to print patient reports that may be sent to providers during HIS/LIS downtime. Ability to retransmit results after HIS/LIS downtime. The analyzer shall require only one interface.

•·         Must have FAIL-SAFE sample management system: Positive tube identification and Positive cassette/position identification.

•·         Require minimal time to perform recurring maintenance (daily, weekly, monthly, etc.). Responses shall indicate the total downtime for each task, not just the hands-on time.

•·         Require minimal start up time from standby mode to operation.

•·         Require minimal reagent preparation. Responses shall include requirements for each.

•·         System shall have detector system for incomplete sample growth

•·         Provides Price-Per-Test pricing for 100% of tests listed in Appendix A which shall include the price associated with consumables such as reagents, supplies, consumable/disposable items, parts, accessories and any other item required for the proper operation of the contractor's equipment.

•·         Service/Recurring/Corrective/Preventive Maintenance (PM's): The contractor shall perform all required preventative maintenance.  The use of the Microbiology Analyzer shall cover the range of services provided in a civilian medical treatment facility and all associated maintenance. 

•·         Scheduled preventative maintenance calls shall occur at a frequency to meet minimum manufacture's requirements to keep the analyzers in optimal operating condition.  The contractor shall coordinate service calls with the MTF Biomedical Maintenance (BMET).

•·         A written report shall be provided to the BMET department and laboratory department, detailing each on-site service incident and repairs made.  The contractor's Field Service Report (FSR) shall provide written documentation of each PM visit as to items performed during the PM and any parts that were replaced.

•·         The contractor shall provide a company service technician for support services which must be performed on-site.

•·         Repair actions by contractor personnel shall be continuous until repair is complete unless parts are unavailable. Upon completion of repair activity, the contractor shall consult with equipment operators regarding equipment performance.

•·         Perform operational checks on all systems and correct noted deficiencies.

•·         Replace worn or defective parts that may fail before the next PM.

•·         Equipment Updates.  The contractor shall furnish and install all software updates and equipment modifications provided by the manufacturer.  These updates are provided at no additional cost to the government and installed no later than the next PMI or visit.

•·         Equipment malfunctions.  During regular and after duty hours, all equipment malfunctions will immediately be reported to the contractor via telephone.

•·         Technical/General Services: Contractor shall provide Quality Customer Service:

•·         24/7 technical phone support services and emergency service calls.

•·         Technical specialist support, including method validation and onsite training.

•·         Training:  Provide training for government personnel.