STATEMENT OF WORK (SOW) BioRad Bioplex INTENT: Pursuant to Federal Supply Schedule (FSS) and FSS Contract Clause I-FSS-646, it is the intent of the Pathology Laboratory Medicine Services of the Seattle VAMC, Department of Veterans Affairs (herein afterwards referred to as Seattle VAMC) to establish a contract for BioRad BioPlex. The contract shall be under the FSS Contract, Federal Supply Class (FSC) Group 66 III Cost Per Test (CPT)/ Cost Per Reportable Result (CPRR), Clinical Laboratory Analyzers. The Government will award contract to a single Contractor for Automated Immunoassay Instrumentation. Contractor agrees to the following terms of the contract exclusively with the Seattle VAMC listed by Attachment and awarded in the final contract. The instrument shall be able to perform immunoassays for ANA Screens, Syphilis IgG and RPR, Measles/Mumps/Rubella/Varicella, Herpes Simplex virus (HSV) antibodies, Cytomegalovirus (CMV) antibodies, Epstein-Barr Virus (EBV) antibodies, Vasculitis Panel, Anti-CCP Panel, Celiac Panels, Antiphospholipid Panels, HIV Antibody Panel and Toxoplasma. Vendor will provide methodology for differentiation the of HIV 1 and HIV 2. Additional tests/reagents/instrumentation may be added to the contract as new technology becomes available on the market and added to the base FSS contract. ORDERS: All products ordered under this contract, placed against the Federal Supply Schedule Award Contract(s), are subject to the terms and conditions of the FSS contract. This contract does not obligate any funds. The Government is obligated only to the extent of authorized orders issued under the contract by authorized individuals. PRICES AND TERMS: Seattle VAMC will provide an estimated volume by test. Pricing is based on the AVERAGE daily test volume per instrument/analyzer for each facility. TERM OF AGREEMENT: This will be a single award, firm-fixed price contract for one years and shall be effective for the term of the FSS Contract including additional FSS extensions. The Contractor is required to immediately notify the CO (Government Contracting Officer), in writing, if at any time the FSS contract upon which this contract is based, is no longer in force. The resulting contract shall be automatically extended for the remaining term of the contract without modification upon any extensions of the Contractor s FSS contract. In addition, where a new FSS contract replaces Contractor s current FSS contract, the resulting contract may be reassigned under the new FSS contract for the remaining term of the contract with written agreement between Contractor and the contracting officer. If the Contractor fails to perform in a manner satisfactory to the CO, this contract may be canceled with thirty (30) days written notice to the Contractor by the CO. The Contractor shall also reserve the right to terminate this contract with 30 days notification to the CO. IDENTIFICATION: Delivery Orders issued shall be identified by their applicable FSS Contract Number and contract Number. FSS & contract identification numbers are assigned through the VHA Procurement Activity. ORDERING METHOD: The Seattle VAMC may order products via E-mail, telephone, facsimile or other written communication, identifying the products by number, quantity, purchase price, address for delivery, and any special instructions. STATEMENT OF WORK/SERVICES TO BE PROVIDED: 1. GENERAL REQUIREMENTS: 1.1. The vendor(s) shall furnish all clinical laboratory supplies, materials, equipment, and services necessary for the performance of the work as described herein to the Seattle VAMC. 1.2. A list of the estimated yearly quantities by the Seattle VAMC will be provided under this agreement as reflected in Attachment A. The quantity as listed is an estimate based upon prior history of the actual volume and is intended to provide the potential contractor a basis for calculating their pricing. It is not a guaranteed minimum. 1.3. The pricing shall be based on new equipment. Remanufactured or used models will not be accepted. 1.4. The analyzer shall streamline all aspects of testing, thereby enhancing operational efficiency, improving turnaround time, supporting improved patient outcomes, and improving the productivity of the using facility. 1.5. Vendors shall provide the participating facility with Food and Drug Administration (FDA) approved analyzer/equipment, reagents, controls, calibrators, and any consumable part necessary for analyzing/testing. Vendor shall list the consumable parts provided. 2. SYSTEM REQUIREMENTS: 2.1. Offered analyzer must be capable of producing accurate and reproducible results by established diagnostic methods. The analyzer shall provide accurate test assay results without excessive malfunctions, breakdowns, or service calls. 2.2. Total time to analyze a single test shall be less than 1 hour. 2.3. Vendor must provide at least two levels of commercial quality controls to be analyzed to meet facility and regulatory agency requirements. 2.4. Analyzer shall have the capability of providing printouts for all patient results, calibrators, and controls. 2.5. All consumable supplies (reagents, calibrators, controls, disposable, etc ) required for the proper operation of the contractor s equipment and that are necessary to perform tests on the equipment shall be included and furnished by the contractor. 2.6. The system shall have a design that supports the result integrity/removes the possibility of sample carryover. 2.7. The vendor shall state the open date stability for the reagents/supplies in the kit. 2.8. The vendor shall supply equipment that shall perform satisfactorily at any laboratory relative humidity between 15 and 85 percent and any laboratory temperature between 50º and 90º Fahrenheit (10º to 30º Celsius). 2.9. The system shall have a design that support on demand testing. 2.10. The system shall have the design to utilize ready to use reagents 2.11. The system shall be able to process 2200 samples per hour. 2.12. The system robotic arm should possess clot detection. 2.13. The system shall have automated calibration 2.14. The system shall have the design for Bi-directional LIS connectivity 2.15. The system shall have the design to run autoimmune and infectious disease tests in single test format 3. INSTRUMENTATION AND SOFTWARE: 3.1. The vendor is to conduct and complete the Medical Equipment Pre-procurement Assessment (VA Directive 6550 Appendix A) for the Office of Information Technology (OI&T) for the facility for any medical device that will be connected to the VA information network. The vendor then shall provide evidence of VACO approved remote network communication system that continuously collects and monitors performance data of the analytical systems following all the policies and procedures outlined in the VA Directive 6500, Information Security Program, and its handbooks to ensure appropriate security controls are in place. 3.2. The equipment shall include 120 volt UPS that has a 2-3 hour back-up capability. The vendor shall be responsible for replacing the UPS should it become dysfunctional and provide battery replacement as needed. 3.3. The system shall support multiple barcode formats including but not limited to Code 39, Code 128, and Codabar or current VA standardized barcode that may be enabled concurrently. 3.4. The system shall have a barcode reader for sample identification. The barcode reader must be able to read current standardized VA barcode formats. 3.5. VA patient information cannot reside at the vendor s location or on removable media. Only the instrument configuration can be stored on removable media. 3.6. The vendor shall provide all upgrades to the equipment hardware, software, and operating systems without additional charge to the Government. 3.7. Requests for upgrades or replacement, due to workload increase, excessive instrumentation/test kit failures/malfunctions, breakdowns, or service calls will be evaluated as needed/annually by the facility with communication to the vendor for modification of the contract. A high incidence of problems with any instrumentation/ test kits may indicate probable non-compliance with the terms of this contract and will entitle the facility to replacement with equipment/test kits that can produce the required criteria of this contract satisfactorily to the user. 3.8. The contractor shall remove all equipment within 90 days after notification of the expiration of the terms of this contract but not until the completion of new vendor s equipment installation inclusive of completed cross over studies. The facility, per their protocol, will be responsible for the removal/erasing of the hard drive at analyzer removal/upgrade. If the Seattle VAMC chooses to retain the hard drive, it will be at no additional cost to the VA. 3.9. The contractor and their personnel shall be subject to the same Federal laws, regulations, standards and VA policies as VA personnel, regarding information and information system security. These include, but are not limited to Federal Information Security Management Act (FISMA), Appendix III of OMB Circular A-130, and guidance and standards, available from the Department of Commerce s National Institute of Standards and Technology (NIST). This also includes the use of common security configurations available from NIST s Web site at: http://checklists.nist.gov 3.10. To ensure that appropriate security controls are in place, Contractors must follow the procedures set forth in VA Information and Information System Security/Privacy Requirements for IT Contracts located at the following Web site: http://www.iprm.oit.va.gov 4. INSTALLATION AND VALIDATION: 4.1. The vendor shall provide the participating facility with all reagents, calibrators, controls, linearity material, and any supplies needed at installation and during training of staff. The vendor shall pay all shipping costs for the analyzers and all supplies needed for the installation, correlation studies and training of staff. 4.2. At installation of new equipment, vendor will provide all of the manpower and the technical support specialist(s) to assist in equipment installation/set-up, correlation studies (evaluation/comparison of data sufficient to satisfy CAP standards, CLSI and related documents, and Federal Regulations), staff training, methodology problems, and questions. Method Performance/Comparison shall include but is not limited to: 4.3. Accuracy studies for the analyte: A minimum of 30 samples, consisting of an adequate number of both high and low samples will be run by the present and the proposed method. Contractor will analyze results and provide data to support acceptance of the new method. The evaluation will include validation of accuracy, in concordance to current method and meet current standards defined by CLSI. 4.4. Precision study using low and high control material: This will consist of a within run precision study of at least 10 low and 10 high controls. 4.5. Specificity Studies: Manufacturer s package insert, including any limitations and/or interferences, will be provided by the contractor. 4.6. Sensitivity Studies: Manufacturer s package insert will be provided by the contractor. 4.7. Carryover Studies: Presence of assay carryover shall be ruled out during the contractor s instrument validation process. Documentation of carryover studies performed during the validation process will be provided by the vendor. 4.8. At installation/set-up the vendor/technical support specialist shall perform and place in a labeled binder all validation studies including: installation/set-up, correlation studies, linearity and cross-over studies. Evaluation/comparison data shall be sufficient to satisfy CAP standards and shall be completed within two weeks of installation at the facility. The support specialist shall assist with staff training, in-services to laboratory personnel and clinicians, and assist with any methodology problems and questions. 4.9. The vendor shall provide equipment installation and possible reinstallation costs if the equipment is required to be moved due to construction or laboratory redesign. 4.10. The vendor shall supply a quarterly shipment and indicate how much storage space would be needed. The vendor shall ensure that all reagents/supplies received quarterly shall have at least a six month expiration date. The vendor shall work with the facility to adjust reagent supply to match workload changes and to provide the option annually for the facility to adjust the shipment table. The vendor shall state what their policy is in regards to adjusting a standing order or ordering an additional shipment of supplies. 5. SUPPORT SYSTEMS (SERVICE, PREVENTATIVE MAINTENANCE AND SHIPPING OF SUPPLIES) 5.1. Vendor will provide technical support services at no additional charge to the facility. Technical support by telephone shall be available 7 days a week, 24 hours a day. Technical support shall return all downtime calls within one hour. Should on-site service be required, the contractor s field service organization shall provide on-site service response within 24 hours after being contacted. The repair person shall also, prior to departure, provide the visited site with written documentation of services performed. 5.2. Technical support shall place a service call for repairs if the technologist is unable to repair the analyzer within one hour of trouble-shooting with the hotline or on weekends/holidays/irregular tours when technologists may be unable to work with the hotline due to the facilities staffing. 5.3. Service is to include, at no charge, all labor, travel, and parts necessary to make repairs. 5.4. The vendor shall provide instrument support service sufficient to provide assistance with troubleshooting and repair of the analyzer. The vendor may list their service options available. Or the following service option may be available: 24 hours/day, 7 days/week. The support service shall follow-up all down calls within 1 hour. The FSR at all times shall keep the facility informed of the time line for when repairs are to be completed. All repairs on instrument shall be complete (at no cost to the facility) within 24 hours from the time the field service engineer arrives. 5.5. The vendor shall pay for the laboratory testing at a reference facility if the equipment requiring repair is inoperative due to malfunction through no fault or negligence of the facility for a total of more than 24 hours. Downtime for each incident shall start from the time the facility makes a bona fide attempt to contact the vendor s designated representative until the analyzer is returned to good operating order. 5.6. In the event that the consumables are found to be defective and unsuitable for use with the vendor's equipment, or the vendor has failed to comply with the requirements for routine supply delivery, the contractor shall deliver the consumable supplies within a period of twenty-four hours after receipt of the verbal order for priority delivery from the Government activity. If either circumstance has occurred, the contractor shall deliver to the requesting facility, in the most expeditious manner possible, without additional cost to the Government, the necessary consumables in sufficient quantity as required to allow operation of the contractor's equipment for one week (under normal Government test load volume). 5.7. Vendor will pay all routine shipping fees for all supplies, consumables, and equipment to perform testing. 5.8. The vendor must provide replacement parts at no charge and any components necessary for the operation of the instrument(s) to produce patient results. 5.9. The vendor s technical service representatives must comply with the facility s requirements for onsite vendor representatives. This may require a low risk background investigation by federal authorities paid for by the vendor. 6. TRAINING AND PROCEDURES: 6.1. Vendor must provide all education/training on site during installation or update to the equipment. Training to include staff on all requested shifts. Training must include basic operation, quality control, interpretation, and reporting of results, required user performed maintenance, and troubleshooting. Vendor must provide a documented record of training (training checklist) completed for all trained staff before leaving site following installation at the site. 6.2. The vendor shall provide initial in-depth training for two key operators. Key operator training is to include all costs of off-site training, i.e., transportation (air and ground), room and board, etc. 6.3. The vendor shall provide on-site refresher instrument training in renewal option years of the contract if so exercised. 6.4. Vendor must supply all necessary procedure manuals, troubleshooting manuals, operator manuals, and SDSs (also available on CD format or on-line). Procedures must be in the Clinical and Laboratory Standards Institute (CLSI) format. Vendor must provide assistance in creating preventive maintenance and quality control records or logs to meet the needs of the facility. 7. OTHER TERMS AND CONDITIONS: 7.1. Vendor shall specify calibration frequency, time required to perform calibration and any specific steps that must be followed prior to calibration. 7.2. Vendor shall state if the instrument paper is included in the consumable parts. 7.3. Vendor shall provide documented evidence confirming the system design removes the possibility of any sample carryover. 7.4. The vendor shall list the frequency and the supplies needed to check the pipetting mechanism of the instrument. 7.5. The vendor shall list all of the reagents/supplies needed for testing, state if the reagents/supplies are stored at room temperature or refrigerated, state if the reagent/supplies are color-coded and state the size of the kit (as it relates to the amount of storage space required for a quarterly shipment). 7.6. The vendor is to define the actual hands on maintenance time required for daily, weekly, monthly, quarterly, and as needed maintenance. The vendor is to include the analyzer/technologist time required to perform each maintenance task. The vendor shall list which tasks are user level and which tasks are service level. 7.7. The vendor shall list analyzer/utility requirements (electrical, water, plumbing, reagent and bio-hazardous disposal, etc.). 7.8. The vendor shall provide weight and dimensions of proposed analyzer. Footprint of system should be small and fit on a typical laboratory counter top. 7.9. The vendor shall indicate any routine and/or special items required to operate/maintain the equipment/analyzer in optimal condition such as but not limited to: paper, printer cartridges, drainage systems, surge suppressors, UPS, etc. Any items excluded by the vendor shall be delineated in their proposal. The cost of the excluded items must be incorporated in the price proposal. 7.10. Provide information if the system has a data management system that allows the user to monitor and analyze data and quality control. System includes flags for unusual results and failed quality control. 7.11. The vendor shall indicate if electronic operating manuals and troubleshooting guide as well as a preventive maintenance guide and log are provided to the labs. 8. PERIOD OF PEFORMANCE Base Year 02/01/2026-01/30/2027 Option Year 1 02/01/2027-01/30/2028 Option Year 2 02/01/2028-01/30/2029 Option Year 3 02/01/2029-01/30/2030 Option Year 4 02/01/2030-01/30/2031  ATTACHMENT A Estimated Volume by Test BioPlex 2200 ANA Panel Catalog # ANA Screen 665-1150C1 Centromere-B 665-1150C12 Chromatin DNP 665-1150C3 dsDNA 665-1150C2 Jo-1 665-1150C11 Ribosomal P 665-1150C4 RNP 665-1150C9 Scl-70 665-1150C10 Sm 665-1150C7 Sm/RNP 665-1150C8 SS-A 665-1150C5 SS-B 665-1150C6 Vasculitis IgG Panel Catalog # P-ANCA (MPO) 665-1850C1 C-ANCA (PR3) 665-1850C2 Anti-GBM 665-1850C3      Anti-CCP Panel Catalog # Anti-CCP 665-3250C1      Celiac IgA Panel Catalog # tTG IgA 665-2350C1 Deamidated Gliadin Peptide (DGP) IgA 665-2350C2      Celiac IgG Panel Catalog # tTG IgG 665-2250C1 Deamidated Gliadin Peptide (DGP) IgG 665-2250C2      AntiPhospholipid Syndrome IgA Panel Catalog # Anti-Cardiolipin (aCL) IgA 665-2150C1 ß2GPI IgA 665-2150C2      AntiPhospholipid Syndrome IgG Panel Catalog # Anti-Cardiolipin (aCL) IgG 665-1950C1 ß2GPI IgG 665-1950C2      AntiPhospholipid Syndrome IgM Panel Catalog # Anti-Cardiolipin (aCL) IgM 665-2050C1 ß2GPI IgM 665-2050C2 EBV IgG Panel Catalog # EBV EA-D IgG 665-1250C3 EBV NA IgG 665-1250C2 EBV VCA IgG 665-1250C1      EBV IgM Panel Catalog # EBV Heterophile IgM 665-1350C2 EBV VCA IgM 665-1350C1      Syphilis IgG Panel Catalog # Syphilis IgG 665-1450 RPR 19000073      ToRC IgG Panel Catalog # Toxoplasma IgG 665-1650C1 CMV IgG 665-1650C3      RC IgM Panel Catalog # Toxoplasma IgM 19000064 Rubella (Qual) IgM 665-3850C1 CMV IgM 665-3850C2      HSV 1 and HSV 2 IgG Panel Catalog # HSV 1 665-3350C1 HSV 2 665-3350C2      MMRV IgG Panel Catalog # Measles 665-2450C1 Mumps 665-2450C2 Rubella, Qual. 665-2450C3 VZV 665-2450C4      HIV Ag-Ab Panel Catalog # HIV Ag-Ab Screen HIV-1 Ab HIV-2 Ab HIV p24 Ag 665-3455C INFORMATION SECURITY LANGUAGE The C&A requirements do not apply, and that a Security Accreditation Package is not required.
