Electrophoresis Analyzer (Intent to Sole Source)

STATEMENT OF WORK Iowa City VA MEDICAL CENTER (VAMC) Protein Electrophoresis Analyzer GENERAL: The Contractor shall provide to the laboratory full instrumentation, installation, correlation studies, consumables and supplies, maintenance and preventive services and a quality control program for an analyzer to aid in the diagnosis of monoclonal gammopathies, multiple myeloma, and other plasma cell proliferative disorders. The equipment is provided for use in conjunction with reagents being purchased on a reagent rental basis for the Department of Veterans Affairs Medical Center, Iowa City, IA. BACKGROUND: Protein electrophoresis is used to identify the presence of abnormal proteins, to identify the absence of normal proteins, and to determine when different groups of proteins are present in unusually high or low amounts in blood or other body fluids. Protein electrophoresis separates proteins based on their size and electrical charge. This forms a characteristic pattern of bands of different widths and intensities on a test media and reflects the mixture of proteins present in the sample. The pattern is divided into five fractions, called albumin, alpha 1, alpha 2, beta, and gamma. Alterations to the usual appearance of the patterns formed can help in the diagnosis of the disease. Once a disease or condition has been diagnosed, electrophoresis may be ordered at regular intervals to monitor the course of the disease and the effectiveness of treatment. PLACE OF PERFORMANCE: Pathology & Laboratory Medicine, Clinical Laboratory (BW-120), 601 Highway 6 West, Iowa City, IA 52246. PERFORMANCE PERIOD: Base plus four (4) one year option renewal periods. Dates to be determined. Any renewal options are exercised at the discretion of the Government. Award is subject to the availability of funds. Any changes made to this document by another party are invalid unless agreed to in writing by both parties via a bilateral modification. EQUIPMENT DESCRIPTION: Contractor shall retain ownership of the instrumentation throughout the term of the agreement. Upon completion of the agreement, contractor shall provide removal of the instrumentation for the VA's facility. Offered equipment shall be new and state of the art. Re-manufactured and discontinued models will not be accepted. Hardware Features - The automated protein electrophoresis instrumentation must provide the following functions: Must be a bench top model with an approximate footprint of L 36 inches x H 24 inches x D 28 inches. Must use capillary technology with at least 8 capillaries. Must be a walk away system, allowing for automatic start-up and shut down and automatic maintenance. Must be a temperature-controlled system. Must be able to run multiple protocols simultaneously. Must have continuous sample loading. Must have cap piercing technology. Must be able to process serum and urine proteins and perform immunotyping. Must be able to load up to 15 sample racks at a time. Must have RFID reagent traceability. Must allow for bidirectional LIS interfacing. Must have on-board quality control including Levy-Jennings statistical analysis. Support Features Supplies - The vendor must provide at no additional cost all reagents, calibrators, controls, consumable/disposable items, parts, accessories, and any other item included on the list of supplies defined in the contract and required to establish instruments for operation. The vendor will assist with, to the satisfaction of the Government, all validation studies including method comparison with current analyzer at no cost to the Government. The vendor will perform all the statistical analysis and report data in an organized, clearly comprehensible format. Contractor shall provide reagent rental that includes instrumentation, training, consumables, reagent calibrators, controls, supplies, disposable items, parts, maintenance, and any other item required for the proper operation if the contractor's equipment in accordance with the manufacturer's specifications. b) Training - The vendor will provide training for at least two operators, at no additional cost. Utilization of the training slots will be mutually agreed upon between the Iowa City VA facility laboratory and the vendor. c) Equipment Preventative Maintenance/Repair Service - The vendor must be able to provide emergency equipment repair and preventative maintenance on instrumentation, offered according to the following terms: 1. A technical assistance center must be available by telephone Monday -Friday during routine business hours with a maximum call back response time of 2 hours. 2. Equipment repair service must be provided during routine business hours. Certain circumstances may dictate the need for repair service to be conducted outside routine business hours. All such arrangements will be coordinated between the contractor and VA laboratory personnel. Vendor will be responsible for all travel, parts, and labor costs. 3. Equipment response time will be no more than 24 hours. 4. Preventative maintenance and malfunction repairs are the responsibility of the contractor. PMs are completed Monday - Friday during routine business hours. Routine daily, weekly, and monthly maintenance is the responsibility of the facility. 5. A malfunction incident report shall be furnished to the installed site upon completion of each repair call. The report shall include, as a minimum, the following: (a) date and time notified (b) date and time of arrival (c) serial number, type, and model number of equipment (d) time spent for repair, and (e) proof of repair that includes documentation of a sample run of quality control verifying acceptable performance. 6. During the term of the IDIQ, should the repair record of any individual piece of laboratory equipment reflect a downtime of 2% or greater of the normal working days in one calendar month, a determination will be made by the designated representative of the Government to replace the malfunctioning equipment with new equipment. The responsibility for maintaining the equipment furnished in good condition in accordance with manufacturer's instructions, shall be solely that of the contractor. Each instrument provided by the contractor shall maintain an uptime of 98% in each month of the term of the agreement. 7. Each notification for an emergency repair service call will be treated as a separate and new service call. 8. Software upgrades will be provided as available, and within 2 months of release, and will maintain compatibility of systems with whatever host LIS is in place. Upgrades or Replacement: Request for instrumentation upgrades or replacement, due to workload increase, menu changes, technological upgrades, excessive instrumentation failures/malfunctions, breakdowns, or service calls will be evaluated as needed/annually with communication to the vendor for modification of the contract. A high incidence of problems with any equipment/analyzer supplied may indicate probable non-compliance with the terms of this contract and will entitle the facility/clinic to its replacement with other analyzer(s) that can produce the required criteria of this contract satisfactorily to the user. Removal of instrument by the vendor shall be performed within 60 days after request. The vendor must provide upgrades to both the equipment hardware and software to maintain the integrity of the system and the state-of - the art technology, at no additional charge to the Government. These must be provided as they become commercially available and at the same time as they are being provided to commercial customers. e) Ancillary support equipment - The vendor will provide, install, and maintain, as indicated, any and all ancillary support equipment to fully operate the analyzer as defined in these specifications, including universal interface. In addition, the vendor will include all ancillary components that are customarily sold or provided with the model of equipment proposed, e.g., starter kits, tables/stands, etc. The vendor is responsible for providing all hardware required for the connection, implementation, and operation of the interface (if needed) to the universal interface and any incremental fee that is required each time an instrument is added to an existing universal interface system (see requirements below). Likewise, the vendor will provide all necessary software support for ensuring that successful interfacing has been established. Specific requirements for the communication of the data streams will be unique to the instrument system involved and dictated by the manufacturer itself. Information necessary to make the determination for type and amount of interfacing equipment is supplied in the chart below. If the site already has a universal interface box, the vendor is responsible for everything leading up to the box including any incremental fee required to add additional equipment (e.g., licenses, ports/cards, cables, software, etc.) to the universal interfacing system. If the site does not have a universal interface and one is needed to optimally interface the instrument, then the vendor is responsible for the acquisition of the universal interface box and everything else needed to connect with VistA. If there are any software upgrades in the instrument during its life, the vendor is responsible for seeing that the interface can accommodate any changes in the data stream going to the VistA. f) Commercial offerings - The vendor will provide to the VA facility any additional support material that is routinely provided to equivalent commercial customers and will assist in regulatory compliance, e.g., PC computer diskette of their procedure manual or an on-line procedure manual in the instrument software. g) Implementation/transition timeframe - The implementation of the services/requirements described in this solicitation shall be completed as soon as feasible, based upon system availability. Offerors shall provide with its quotation a plan for transitioning services from the incumbent contractor to the newly awarded contractor. Contractor's submitted transition plan shall include installation and training of personnel, transition of all testing materials, reagents, and supplies, etc., performance of all correlations and validations. Failure of the contractor to confirm the transition period shall be considered as sufficient cause to terminate contract for cause under the Termination for Cause clause of the contract.