Salient_Characteristics.pdf

Salient Characteristics Analyzer and Reagents Cost Per Test for Chlamydia Trachomatis (CT), Neisseria Gonorrhea and Trichomonas vaginalis and Human Papilloma Virus (HPV)

C.1 The Reagent Rental is based on a cost per kit price that shall include costs covering:

C.1.1 Equipment use.

C.1.2 Data management system.

C.1.3 All consumables including: reagents, standards, controls, and supplies.

C.1.4 Replacement calibrator (normalizer) as needed.

C.1.5 Delivery and installation of equipment

C.1.6 All necessary maintenance to keep the equipment in good operating conditions; this element includes both preventative maintenance and emergency repair.

C.1.7 Training for governmental personnel.

C.1.8 Additional supplies required for commencing operations and performing required correlation studies.

C.2 Reagents shall be provided bearing the same lot number within the designated shipments. These items shall be of the highest quality, sensitive, specific and tested to assure precision and accuracy. The contractor shall provide stock that meets proficiency testing standards of the College of American Pathologist (CAP), the Joint Commission, the Clinical Laboratory Standards Institute (CLSI), and be approved by the Food and Drug Administration (FDA).

C.3 Testing System shall have the following characteristics:

C.3.1 At a minimum be able to identify: Chlamydia Trachomatis (CT) and Neisseria Gonorrhoeae (NG), Trichomonas vaginalis and Human Papilloma Virus (HPV).

C.3.2 Instrument throughput of greater than 200 samples in an eight hour period with both a CT and NG result, using only one person with total hands on time of less than 60 minutes.

C.3.3 The testing system shall be at least semi-automated to allow for walk away operations to include ultra-high reliability, robotic pipetting, specimen tracking, easily learned upgrades, an enclosed testing area, pipettor travel lanes, fluid transfer verification, absent/defective tip detection, no pipettor priming fluid to drip into specimens, enclosed, segregated area for biohazardous waste. All testing must be performed within one system in order to produce a CT and NG result.

C.3.4 Assay shall be a FDA approved nucleic acid amplification assay kit for the in vitro detection of Chlamydia trachomatis, Neisseria gonorrhea, Trichomonas vagina/is and Human Papilloma Virus from symptomatic and asymptomatic patients collected by endocervical swabs, male urethral swabs, patient or clinician collected vaginal swabs, and Cytyc ThinPrep liquid pap specimens.

C.3.5 The system shall have a Data management system for storage of patient results, quality control and preventative maintenance data. System shall be interfaced to the analyzer and capable of being interfaced to the Composite Health Care System (CHCS) for rapid test data transfer. The system shall have a Data management system for storage of patient results, quality control and preventative maintenance data. System shall have at a minimum a uni-directional interface and/or a bi-directional interface to the analyzer and to the hospital information system (CHCS). The contractor shall have a Certificate of Networthiness (CON). The contractor shall have a BAA agreement with the local site if the contractor wants the ability to VPN.

C.3.6 The contractor is required to provide new state or re-manufactured state of the art equipment. No used, refurbished, or like-new equipment. Discontinued models are not acceptable.

C.3.7 The contractor shall provide all upgrades to the equipment hardware and operating system software without additional charge to the government. These enhancements to the contractor's equipment shall be delivered to the government site and installed by the contractor within 60 days of their issuance of date of first commercial availability.

C.3.8 All models shall perform satisfactorily at any laboratory temperature between 68 and 80 degrees Fahrenheit and at any laboratory relative humidity between 40 and 80%.

C.3.9 The analyzer(s) shall be fully operational on the first day of this contract's performance period.

C.3.10 The contractor shall provide a courtesy copy of each invoice to the operating facility's COR (Contracting Officer

Representative).

C.3.11 In the event that the contract is terminated for any reason, the manufacturer must allow the analyzer(s) to remain in place for a period not to exceed 60 days at no additional cost to the government beyond the contracted price, for the purpose of meeting regulatory requirements of performing correlation and validation studies.

C.4 Sample and Collection Devices: The instrument shall use collection containers with piercible caps and all specimen types shall be treated in the same manner (No special handling for any samples).

C.5 Special Handling for Emergency Orders of Supplies. In the event that the consumables are found to be defective and unsuitable for use with the contractor's equipment, or the contractor failed to comply with the requirements for routine supply delivery, the contractor is required to deliver the consumable supplies within 24 hours of receipt of verbal order(s) from the Contracting Officer's Representative (COR) or the Contracting Officer (KO). If either circumstance has occurred, the contractor shall deliver to the government the necessary consumables in sufficient quantity as required allowing operation of the contractor's equipment for one week (under normal government test load volume).

C.6 The contractor, without additional charge to the government, shall provide advance training for two operating personnel and the option of two training slots for each option year exercised. In addition, the contractor shall provide supplemental operating training to the above government personnel, without charge to the government, upon installation of the upgrade(s) in equipment hardware or operating system software connected with the operation of an instrument already furnished.

C.7 Site Preparation:

C.7.1 The contractor shall furnish site preparation specifications in writing. These specifications shall be in such detail as to ensure that the equipment to be installed shall operate and conform to the manufacturer's specifications.

C.7.2 The government will prepare the site at its own expense and in accordance with the specification(s) furnished by the contractor. The analyzer must be able to conform to the government's space allocation in order to meet all safety standards and to not impede current workflow processes and testing conducted in the area.

C.7.3 Any alteration or modifications in site preparation, which are attributable to incomplete or erroneous specifications provided by the contractor, which would involve additional expense to the government, shall be made at the expense of the contractor.

C.8 Ownership of Equipment:

C.8.1 Title to equipment shall remain with the contractor. All accessories furnished by the contractor will accompany the equipment when returned to the contractor.

C.8.2 The contractor, at termination and/or replacement of equipment, shall remove the equipment. The contractor shall disconnect the equipment and shall be responsible for all packing and shipping required to remove the equipment within seven (7) calendar days.

C.9 Preventive Maintenance. The contractor shall perform preventative maintenance as needed to assure the continued reliable operation of the equipment.

C.1O Emergency Repair:

C.10.1 Emergency repairs shall be performed after notification that equipment is inoperative. The contractor shall provide the government with a designated point of contact and shall make arrangements to enable his maintenance representative to receive such notification and be on site within 24-48 hours.

C.10.2 Technical services shall replace overnight (Swap out program) any of items utilized in the system set up.

C.10.3 The contractor shall furnish a malfunction incident report to the COR upon completion of any maintenance call. The report shall include, as a minimum, the following: (a) date and time of notification, (b) date and time of arrival, (c) type and model number(s) of equipment. (d) time spent for repair, (e) description of malfunction and (f) proof of repair.

C.11 Service:

C.11.1 The Contractor shall provide direct customer service and support, during normal business hours and on-call emergency repair service support, to assist operators in correcting equipment operation problems.

C.11.2 The Contractor shall perform preventive maintenance services {PMS), safety tests, calibrations, and unscheduled repair services in accordance with procedures and practices prescribed by the manufacturer of the equipment.

C.11.3 The Contractor shall provide a full unscheduled and preventive maintenance service for the lease period. The agreement shall be inclusive of all costs for the performance of scheduled periodic maintenance (as required by the Contractor's instrument maintenance manuals), unscheduled maintenance and repair of the analyzers and any associated equipment provided by the Contractor as part of the analyzer system, including replacement parts, replacement part shipment costs, and service technician travel costs for performance of maintenance services.

C.12 Material Safety Data Sheets (MSDS): The contractor shall provide material safety data sheets (MSDS) for each item delivered under this contract that is considered to be HAZARDOUS MATERIAL by its representative U.S. Government. The MSDS shall contain information on the hazards associated with each specific chemical or material. The MSDS shall contain as a minimum the following information: identification of the specific hazard, the required practice for the safe use of the product, first aid procedures, and what to do in the event of a spill or other mishap or accident.