6515--596-23-4-029-0089 - Immunofluorescent Antibody Testing
Statement of Work (SOW) Immunofluorescent Antibody Testing The Contractor is to provide the Lexington VA Health Care System, Special Reference Lab (SRL), with a monthly rental agreement of an automate... Statement of Work (SOW) Immunofluorescent Antibody Testing The Contractor is to provide the Lexington VA Health Care System, Special Reference Lab (SRL), with a monthly rental agreement of an automated autoimmune testing system, which shall have the capability of processing and reading autoimmune Immunoflourescent Antibody (IFA) slides, in accordance with the terms and conditions stated herein. The instrument shall be able to perform the complete autoimmune testing menu, as described below, and meet the performance characteristics for accuracy and precision, as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSU). The instrument system used must be approved by the Food and Drug Administration (FDA). The Contractor shall propose the suggested/recommended equipment/reagents that meet the requirements of the facility. Item Number Description Quantity Unit of Measure 0001 Automated Autoimmune Testing System 2 each Image Navigators w/8 slide stage and 2 laser printers Remote Review Station Hardware 2 each AFT3200 Sample Processing Stations Network Hardware Bundle (NAS, switch) 3 each Network Software Licenses for 2 Workstations and 1 Remote Review Station Extended Warranty On-going Software upgrades Technical Support and Yearly Program Management 12 MO 0002 Fluorescent Hep-2000 ANA Bulk Pack - 2100 Wells/KT 14 KT 0003 Fluorescent nDNA Bulk Pack w/IgG - 1400 wells/KT 7 KT 0004 Rat LKS Tissue FA Test Kit -800 Tests/KT 28 KT Contractors are required to provide a price per reportable patient result. The per patient reportable shall include costs covering: (a) equipment use; (b) all reagents, standards, controls, supplies, consumable/disposable items, parts, accessories and any other item required for the proper operation of the contractor s equipment and necessary for the generation of an FDA approved autoimmune patient reportable result by Immunofluorescent Assay (IFA). Additionally, instrumentation shall include a surge protector and battery backup and a printer to print both patient results and quality controls. This per patient reportable result price shall also encompass all costs associated with dilution; repeat and confirmatory testing required producing a single patient reportable result. It shall also include the material to perform as well as all other costs associated with quality control, calibration and correlation study testing that is prescribed by the Clinical and Laboratory Standards Institute (CLSI). (c) all necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs); and (d) training for Government personnel. Contractors are required to provide delivery, installation, and removal of equipment at no additional charge. The instrumentation will have the capability of performing tests on approximately 500-550 patient samples per week, with those patient samples being tested over a 4-day, eight hour per day work week. PRICES AND TERMS: Lexington VA Health Care System, estimates the autoimmune testing as below. For the purposes of this contract, number of test wells was used to calculate test volume (includes all controls, patients and titers), as there are considerable differences between vendors as to slide configuration. Pricing shall be based on the average yearly test volume per instrument/analyzer. The Government estimates the volumes listed, but does not guarantee volumes as listed; they are ESTIMATES ONLY. This is an IDIQ (Indefinite Delivery, Indefinite Quantity) agreement. Three slide types will be needed: ANA (Antinuclear Antibody) Hep2000, Tissue (Rat Liver Kidney Stomach, or equivalent) and dsDNA (double stranded deoxynucleic acid). ANA (Antinuclear Antibody) Hep2000: 29,250 wells per year Tissue (Rat Liver Kidney Stomach, or equivalent): 22,152 wells per year dsDNA (double stranded deoxynucleic acid): 9,568 wells per year TERM OF AGREEMENT: The agreement shall be effective for one year with four renewable option years. IDENTIFICATION: Purchase Orders issued will be identified by Contract Number. ORDERING METHOD: The Lexington VA Health Care System will order autoimmune slides, as needed, via telephone, facsimile, email, or other written communication, identifying the products by number, quantity, address for delivery, and any special instructions. All products must have a minimum of 90 days shelf-life (before expiration date) upon receipt. All shipping costs shall be included in the quoted price of each line item. DELIVERY TICKETS: Unless otherwise agreed to, all deliveries under this agreement shall be accompanied by delivery tickets or sales slips that shall contain the following information, as a minimum: Name of contractor Contract number Model number or National Stock Number (NSN) Purchase order number Date of purchase Quantity, unit price and extension of each item Date of shipment. INVOICES AND PAYMENTS: The Contractor shall invoice each purchase order, as directed by the ordering activity. Payments will be made by the VA Finance Center, Austin, Texas. INVENTORY AND SUPPLIES: Shall be in accordance with Statement of Work. Delivery of supplies: Shall be in accordance with Statement of Work. Any unexpected changes in methodology/technology shall be at the expense of the Contractor. Alert/Notification of delays in shipments as well as all technical advisory/recalls/alerts, prior to or simultaneously with field alerts shall be forwarded to the Special Reference Laboratory supervisor, Laboratory manager, and the assigned VISN 9 contracting officer. 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 has failed to comply with the requirements for routing supply delivery, the contractor is required to deliver the consumable supplies within 24 hours of receipt of a verbal order for priority delivery from the government activity. If either circumstance has occurred, the contractor will deliver to the government site in the most expeditious manner possible without additional cost to the government. GENERAL REQUIREMENTS {APPLICABLE TO ALL EQUIPMENT): Each model of autoimmune analyzer offered shall comply with all general requirements stated herein. Each Contractor shall submit as part of their offer, technical data or descriptive literature to ascertain that the equipment offered meets the requirements outlined below. The Contractor shall provide instrumentation that is 510k exempt, in sufficient quantity to handle the forementioned workload, as determined by the Special Reference Laboratory supervisor, automated autoimmune slide processor and slide reader. Re-manufactured or discontinued models are unacceptable for this agreement. The Contractor shall state the failure mean time (between failure and mean time to repair) for each piece of equipment offered. Emergency replacement or repair of equipment shall be provided by the Contractor. Contractor shall return calls within 1 hour and repairs shall be completed within 24 hours. AUTOIMMUNE TESTING SPECIAL REQUIREMENTS: The Contractor shall assess equipment, work flow, volumes and space to meet the Lexington VA Health Care System site's requirements. GENERAL REQUIREMENTS: IFA System: The system shall provide slide processor(s) and slide reader(s) capable of processing all the autoimmune slides listed above, with a throughput capable of processing and reading all slides within the constraints of a forty-hour work week. The system must interface with the Lexington VA Health Care System, Laboratory Information System (LIS), to meet the minimum requirements of reading a ten-digit barcode, downloading tests ordered, and uploading test results to the LIS. Processing: The system must process the slides with minimal intervention of the Medical Laboratory Scientists who will operate the system, to the point that the slides are ready to have coverslips added (if needed). The slides may then be moved to the slide reader by the technologist, or may be read on the processing system, as appropriate. Upgrades: The contractor shall provide hardware/software upgrades necessary to maintain the integrity of the system, at no additional charge to the government. These upgrades must be provided as they become available and as they are being offered to commercial customers. Ancillary Equipment and Supplies: The Contractor shall provide, install and maintain, as indicated, any and all ancillary support equipment, consumables/supplies, parts and accessories necessary to fully operate the processor and reader as defined in these specifications, e.g., cabinetry to support/house the analyzer (if necessary), Uninterruptible Power Supply (UPS) capable of supporting the full scope of equipment operation with a built-in line conditioner, for each proposed analyzer. The contractor shall include all ancillary components that are customarily sold or provided with the model of equipment proposed, e.g. starter kits, tables/stands, etc. Interface: The contractor shall be responsible for providing all hardware required for the connection, implementation and operation of the interface to the universal interface, including the license for Data Innovations connection(s), the connectivity hardware for Data Innovations, and the yearly maintenance and support for the Data Innovations license for the first (base) year of the contract. Maintenance and Repair: The Contractor shall be able to provide emergency equipment repair and preventative maintenance, and any incremental support equipment, offered according to the following terms: A technical assistance or support center shall be available by telephone hot-line Monday through Friday (except Federal Holidays) with a maximum call back response time of 1 hour and with on-site service provided, not to exceed 24 hours following determination that site service is required. The technical assistance center shall be staffed with personnel who are fluent in English, without the use of an interpreter. Every notification for a repair service call shall be treated as a separate and new service call. During the term of this contract, should the repair record of any individual piece of laboratory equipment reflect a downtime of more than 48 hours per quarter, a determination will be made by the designated representative of the Government to replace the malfunctioning equipment with new equipment, at no additional cost to the government. The responsibility for maintaining the equipment furnished in good condition, in accordance with manufacturer's instructions, shall be solely that of the contractor. The Government agrees to maintain the equipment according to manufacturer's specifications. A malfunction incident report shall be furnished to the Laboratory upon completion of each repair call. The report shall include, as a minimum, the following: date and time notified date and time of arrival serial number, type and model number of equipment time spent for repair, and proof of repair that includes documentation of a sample run of quality control verifying acceptable performance. Scheduled preventative maintenance calls shall occur at a frequency to meet the minimum manufacturer's requirements to keep the equipment in optimal operating condition. The contractor will be responsible for tracking and scheduling all preventive maintenance. This must conform to instrument specifications and all regulatory requirements. Documentation of the maintenance will be provided to the Laboratory at the time of completion. This maintenance must be provided within two weeks of the recommended schedule. The system must require minimal daily and periodic maintenance. Training: The Contractor shall provide training at the time of installation to include training on the operation of the system, data manipulation, preventative maintenance and basic trouble shooting and repair for 2 key operators. Any training program that involves off-site travel shall include the cost of airfare, room and board for each participant. A training or competency checklist shall be provided by the Contractor. Site Preparation: Site preparation specifications shall be furnished in writing by the Contractor as a part of the equipment proposal. These specifications shall be in such detail as to ensure that the equipment to be installed shall operate efficiently and conform to the manufacturer's claimed specifications. The Contractor shall be responsible for assessing the space available in the facility in order to ensure the right size equipment is provided; thereby not creating a safety hazard. Implementation and Transition: The Contractor shall provide with its quotation a transitioning plan for the complete transition of all services under the awarded agreement including installation and training of personnel, transition of all testing materials, reagents and supplies, etc., and performance of all correlations and validations. This transition shall be completed no later than 30 days after the award of the agreement. This timeline is based on a reasonable attempt of the Contractor to complete all of the necessary implementation requirements within the stated timeframe. Comparison and Validation of Analyzer: The Contractor shall assist, to the satisfaction of the Government, at no cost to the Government, all comparison and validation studies to include any materials and reagents needed for such correlation. The Contractor shall perform all of the statistical analysis and report data in an organized, clearly comprehensible format. This process shall be completed within two weeks of installation of the analyzer and shall be consistent with current CLSI (formerly NCCLS) and related documents, CAP Standards, Joint Commission Standards and Federal Regulations. Procedure Manual: The vendor shall provide a copy of operating procedures in Clinical and Laboratory Standards Institute (CLSI) digital format at time of installation using software compatible with VA (Microsoft Office WORD). TECHNICAL REQUIREMENTS: (1) Bar-code System. The system shall support bar-code recognition for tracking of samples at entry into the system and throughout processing and incubation until such time as the slide is ready to be placed on the reader. The sample tracking system must interface with the reader such that identification does not have to be re-entered into the reader. The system will include a bi directional, bar-coded computer interface compatible with the current VA laboratory information system. The fully operational interface (both hardware and software) shall be immediately available for implementation to the VA computerized hospital information system. The accuracy of the barcode reading must have less than a 1% failure rate. The equipment must accept, at a minimum, characters in specimen identifier that is alphanumeric. Data Management System. The data management system shall be able to support varied programmed slide titers as deemed appropriate by the user. All slides are initially processed at two titers, and the slide processor must be able to be programmed to process those two titers. Positive samples are tittered to endpoint. The system must allow flexible programming for endpoint titers. The reader must be capable of identifying the staining pattern (including mixed patterns) and approximate titer on the ANA slides, and providing a "screen shot" of any other slides so that the technologist can identify the staining pattern and can determine the endpoint titer on any positive samples. This information must transmit to the LIS. The system shall be capable of maintaining all data for up to 30 minutes, in the event of normal electrical power interruptions via battery backup. The system shall have a built-in quality control program to regularly monitor performance of vital components. The system must have the capability to record, store and print the following information: sample location on processor sample location on test slide presumptive negative results presumptive positive results presumptive pattern (for ANA slides) specimen unique identifier and specimen results daily qc results monthly qc results with Levy Jennings Charts Autoimmune Slides. Shall be easily distinguished (e.g. color coded or clearly labeled) for utility or intended purpose. Shall be bar-coded or otherwise labeled with unique identifiers for processing and specimen tracking. Safety: The system must have sufficient safety features to avoid unnecessary exposure to bio hazardous and chemical materials. The exposure to and the volume of bio-hazardous and chemical material generated by the equipment must be minimal and require a minimum amount of handling. All liquid waste must be approved for disposal in the medical center's waste water stream. The reagents should not be listed as carcinogenic or at risk for reproductive toxicity. Characterization of hazardous waste: The Contractor shall provide documentation that it has characterized the hazardous nature of all wastes produced by all equipment, devices, reagents, and discharges in accordance with the requirements of the Code of Federal Regulations Title 40 "Protection of the Environment" Part 261 et seq. and applicable state and local requirements. Documentation shall include a description of the characteristics of the hazardous waste produced as a by-product of the instrument operations Safety Data Sheets (SDS) meeting the requirements of the Occupational Safety and Health Administration (OSHA) and Environmental Protection Agency (EPA), the analytical process used to determine the hazardous nature and characteristics of the waste, and the analytical test results. Testing of hazardous waste is to be done in accordance with testing protocol specified for each individual waste as described in the Code of Federal Regulations Title 40 to make a determination if the waste is a hazardous waste or otherwise regulated. The determination and description shall address the following: Waste toxicity (Reference 40 CFR §261.11 and 40 CFR § 261.24) Waste ignitability (Reference 40 CFR §261.21) Waste corrosivity (Reference 40 CFR § 261.22) Waste reactivity (Reference 40 CFR § 261.23) Hazardous waste from non-specific sources (F-listed) (Reference 40 CFR § 261.31) Discarded commercial products (acutely toxic or P-listed and toxic or U-listed) (Reference 40 CFR § 261.33) Solid Waste (Reference 40 CFR § 261.2) Progress and Compliance: The system must perform IFA testing, as advertised, and meet the performance characteristics for accuracy and precision, as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI). Business Associate Agreement {BAA): A business associate is an entity, including an individual, company, or organization that, on behalf of VHA, performs or assists in the performance of functions or activities involving the use or disclosure of PHI, or that provide certain services involving the disclosure of protected health information (PHI). VHA is a covered entity under the HIPAA Privacy Rule (Privacy Rule). HIPAA regulations require VHA to execute HIPAA-compliant BAAs with certain entities that receives, uses, or discloses VHA PHI in order to perform some activity for VHA. These BAAs obligate VHA business associates to provide the same protections and safeguards to PHI that is required of VHA under the Privacy Rule. Any subcontractor used by the primary contractor is required to abide by government and agency guidance for protecting sensitive and proprietary information. Government's Responsibility: The user will perform routine maintenance and cleaning as required in the manufacturer's operation and maintenance instructions. The user shall maintain appropriate records to satisfy the requirements of this paragraph. Ownership of Equipment: Title to the equipment shall remain with the contractor. All accessories (unused consumables, etc.) furnished by the contractor shall accompany the equipment when returned to the contractor. The contractor, upon expiration of order(s), at termination and/or replacement of equipment, shall remove the equipment. The contractor shall disconnect the analyzer and shall be responsible for all packing and shipping required to remove the analyzer. All patient names and/or patient identifiers must be removed from the hardware and/or software before removal of equipment from the Government Agency. Record Management: Citations to pertinent laws, codes and regulations such as 44 U.S.C. chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228. The contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. The contractor shall not create or maintain any records that are not specifically tied to, or authorized by, the contract using Government IT equipment and/or Government records. The contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act. The contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract. The Government Agency owns the rights to all data/records produced as part of this contract. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. The contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data. The contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format (paper, electronic, etc.) or mode of transmission (e-mail, fax, etc.) or state of completion (draft, final, etc.). No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 270 I. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules. The contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information. (End of Clause)
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