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2 VAMC Cincinnati, Ohio Pathology & Laboratory Medicine Service 9 STATEMENT OF WORK (SOW) FOR THE ACQUISTION OF MOLECULAR INSTRUMENT/ANALYZER I. GENERAL OBJECTIVES AND SCOPE Cincinnati VAMC Pathology ... 2 VAMC Cincinnati, Ohio Pathology & Laboratory Medicine Service 9 STATEMENT OF WORK (SOW) FOR THE ACQUISTION OF MOLECULAR INSTRUMENT/ANALYZER I. GENERAL OBJECTIVES AND SCOPE Cincinnati VAMC Pathology and Laboratory Medicine Service (PALMS) requires an FDA approved fully automated molecular diagnostic system, reagent kits, consumables, supplies, yearly maintenance, and annual customer training for HCV and HIV quantitative viral load testing, CT/NG, TV/MG, HIV 1/2 qualitative, EBV, CMV and HPV testing for clinical diagnostic use. Additional assays may be added to the test menu as they become available at the discretion of the Cincinnati VAMC. The Contractor shall deliver the instrument/analyzer and all related components to the Cincinnati VAMC by September 1, 2025, ensuring installation and setup are completed accordingly. This lease agreement spans one year, with four optional extension years, cost per reportable contract. Acquiring this capability will enables in-house testing, aligning with the VA s 2022-2028 Strategic Plan for timely accessible, and high-quality results. This acquisition enhances efficiency and veteran care. II. BACKGROUND Cincinnati VAMC Pathology and Laboratory Medicine Service (PALMS) is a full-service clinical laboratory, accredited by the Joint Commission, providing high quality testing of blood, fluid, and tissue to support clinicians in diagnosis and treatment of patients. Period of Performance Cost per test lease agreement for the FDA approved molecular analyzer will be in effect for one (1) base contracting year with options to extend the contract for four (4) additional one (1) year periods. The vendor shall remove all equipment within 90 days after notification of the expiration of the terms of this agreement but not until the completion of new vendor's equipment installation inclusive of completed cross over studies. Vendor shall be responsible for removing the hard drive and turning it over to the Cincinnati VAMC Biomedical Service for destruction prior to removal of any analyzer. III. AUTHORITY OF THE ACQUISITION The assigned VISN 10 Contracting Officer (CO) will be the contract awardee and only individual to make any modifications to the contract on behalf of the government. The assigned Contracting Officer Representative (COR) will assist the CO with maintenance of the contract. IV. SCOPE The Contractor shall: Deliver, install, and set up the instrument and components. Provide test validation guidance. Provide technical support and guidance. Provide reagents, consumables, and supplies as requested by Cincinnati VAMC staff. Provide set up for interfaced result reporting, which includes LIS physical connection and translation (drivers), and any required (additional) interface connection license(s). Provide instrument repairs and scheduled preventive maintenance for the instrument and system components. Provide operator training. V. SPECIFIC REQUIREMENTS A. OPERATIONAL FEATURES: The contractor shall provide one FDA approved fully automated molecular diagnostic system which shall conform to the following parameters or capabilities: 1. The instrumentation shall perform all analyses for the required tests with precision as defined by the 1988 Clinical Laboratory Improvement Amendments (CLIA) and the Clinical Laboratory Standards Institute (CLSI) including satisfactory peer group comparison. All required tests are FDA approved. You may find out more information about CLIA 88 at the following site: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/IVDRegulatoryAssistance/ucm124105.htm You may find out more information about CLSI Standards at the following site: http://www.clsi.org/about-us/ B. PERFORMANCE REQUIREMENTS: The following are required 1. Testing Requirements: FDA approved assays for quantitative HIV and HCV testing. FDA approved assay for CT/NG for use with male and female urine, endocervical and vaginal swab, and extragenital swab specimen types. FDA approved assay for TV/MG for use with male and female urine, endocervical and vaginal swabs. FDA approved assay for differentiation and confirmation of HIV-1 and HIV-2. FDA approved assay for detection of EBV. FDA approved assay for detection of CMV. FDA approved assay for detection of HPV. 2. System and Workflow Requirements: System footprint must not require more than 135 of linear wall space or more than 75 inches of depth. Assay preparation process is automated and does not require operator intervention once processing has started. Reagents are ready to use. System does not require external calibration. System accommodates primary or secondary tubes. Minimal tech time is required for maintenance, 30 minutes. System can accommodate multiple assays in one run. 3. Contamination Controls: System incorporates methodology to minimize cross-contamination. 4. Connectivity Requirements: System is fully interfaced (bi-directional) with VistA and Cerner via Data Innovations. 5. Maintenance: The Contractor shall perform preventive maintenance at intervals specified by the manufacturer to ensure proper equipment performance. Preventive Maintenance includes the following: Monthly deliverables shall be received in full. Testing all components for proper test performance. Equipment shall reproduce results according to manufacturer s specifications. After Preventative Maintenance, the Contractor shall submit a detailed work report for notice at no additional cost to the government. Delivery of parts or materials for Preventive Maintenance. The Contractor shall provide all preventive service materials at no additional cost the government. 6. Technical Support: Support Personnel will be available by during business hours each business day, and live representatives via the Contractor s message center will be available by telephone at all other times. Technical support shall be available via telephone during business days (and by message center after hours) to provide troubleshooting assistance or to answer testing inquiries. On-site technical support shall be available for escalations within 24 hours, Monday-Friday, except for Federal holidays. 7. On-site Repairs: For issues that the Contractor determines to require on-site support, the Contractor shall dispatch one or more Support Personnel, normally within 24 business hours after documentation. The Contractor shall submit a detailed work report to include all required materials. For the delivery of repairs, parts, or materials, the Contractor shall provide all parts and materials at no additional cost the government. The Contractor shall remove all parts, equipment or materials replaced or upgraded by the Contractor due to and not limited to repairs, replacements, recall, and upgrades without any cost to the government. 8. Training: The Contractor will provide initial operator training session for the base year and annual training later, if needed. 9. Safety: The Contractor shall immediately notify Cincinnati VAMC of any changes in reagent kit composition, procedure modification, recall notification, or any changes that will affect the performance of the test or procedure according to FDA regulations. 10. Test Performance: All tests, procedures, and equipment must perform at manufacturer s specifications. Deviations from the performance specifications shall be corrected by the Contractor. Test performance will be evaluated by and not limited for performance thru peer comparison, quality control and CAP proficiency testing peer evaluation. C. HARDWARE FEATURES/SOFTWARE FEATURES: The instrumentation shall possess the following features: 1. Multi-tasking computer with adjustable monitor that is easily readable. 2. High throughput laser jet printers with extended paper trays, rapid printing, toners, photoconductors, and memory for each analyzer. Repair or replacement covered by vendor at no cost to the government. 3. UPS must be supplied, maintained and repaired, at no cost to the government during contract. 4. Ability to archive for test counts, controls and calibration data. 5. Dedicated PC to equipment(s) shall have anti-virus installed. 6. Universal Interface configuration, to connect contractor instrument to VA Veterans Health Information Systems and Technology Architecture (VistA) laboratory package for computerized patient record. Vendor shall provide for any required additional software, licenses, cards or programming and RS 232 interface port and required cables or network interface cards (Ethernet connection), as requested by each site, shall be provided with each analyzer. VI. TASKS AND DELIVERABLES A. SUPPORT/SERVICE REQUIREMENTS: 1. The vendor shall provide all equipment, reagents, calibrators, linearity materials, consumable/disposable items, parts, accessories, shipping costs, and any other item required to establish and maintain a fully operational molecular testing system(s). Shipping costs shall be borne by the contractor and shall be included in the offer. The vendor shall notify the COR, or primary contact, if any delays or product shortages occur ASAP. For the Cincinnati VA Clinical Laboratory to maintain this critical service, the vendor shall provide a plan to provide reagents that are delayed or on a shortage. 2. The vendor shall include performance of all validation studies: precision, method comparison with the current instrumentation (if applicable), accuracy (recovery), linearity (reportable range), calibration verification, verification of reference range (normal range), carry-over studies and determination of sensitivity and specificity for all tests listed above. 3. The vendor shall perform all the statistical analysis and report data in an organized, clearly comprehensible format. Vendor shall provide assistance with reference ranges to include handling of data with appropriate software to establish reference intervals. The vendor will assist in establishing a reference range and developing a report. 4. In the event of laboratory renovation or a new laboratory construction, the vendor will move all equipment (analytical instrumentation and automation line) to the new laboratory space, at no additional cost. The vendor will perform all required studies mentioned above following relocation of instrumentation, at no additional cost. 5. In the event an automated line to deliver samples to the platform becomes available, or changes to a new system, the vendor shall agree to install/uninstallation to/from the automated line system. 6. Validation studies must be able to be performed with space limitations, without reducing current capacity for testing. 7. The vendor shall provide all ancillary support equipment to fully operate the instrumentation as defined in these specifications. Remote access for system troubleshooting will be provided only through a National VPN interface site to site connection. Site to site requirements include, but may not be limited to the following: a. MUST support 3DES or AES IPSEC encryption and must be FIPS certified. b. MUST sign a legal agreement with the VA the Memorandum of Understanding/Interconnection Security Agreement (MOU/ISA) c. Communication MUST be limited to explicit VA and vendor systems using a limited set of protocols d. Any device used to connect to VA networks will have anti-virus software installed and up to date. e. All hard drives that contain VA information (sensitive or otherwise) are to be surrendered to the VA upon termination of the contract. 8. Cincinnati VA PALMS requires separate interfaces for both primary and back-up instrumentation. 9. The vendor is responsible for providing everything required for the installation, implementation, and operation of the interface right up to the universal interface box, including the software license fee that may be required each time an instrument is added to an existing universal interface system (e.g., ports, cards, cables, software, licenses, etc.). If there are any software upgrades in the instrument during its life, or changes in the VA Medical Center computerized system, the vendor is responsible for seeing that the interface can accommodate any changes in the data stream going to or from VA s computerized patient record system and system in general. 10. The vendor shall include all ancillary components that are customarily sold or provided with the model of equipment proposed, or needed by the Lab for efficient operations, e.g. starter kits, tables/stands, etc. Vendor shall provide and maintain air duct venting supplies, air compressor, if needed. 11. The vendor shall provide to each VA facility a PC computer CD of their procedure manual, or an on-line procedure manual in the instrument software. The procedure shall be formulated in accordance with current, approved CLSI (formerly NCCLS GP2-A2 or GP2-A3) guidelines. 12. The vendor shall provide operational, maintenance, troubleshooting, small repairs, equipment specifications, and test manuals. 13. Service representative(s) shall provide coverage 24 hours per day, 365 days per year. 14. Required support/service response within one (1) hour of notification and, if necessary, must be able to provide onsite service within 4 hours. 15. Live Customer Support/hotline 24 hours, 365 day per year. 16. All the above requirements listed in this Statement of Work shall apply to any additional tests added during this contract. Some of the tests cannot be performed on site with the current instrumentation or proposed; therefore, we refer them to outside labs. Tests are being developed on a continuous basis. If tests are not available at the time of award, and they become available after the award, we would like to be able to add tests when available. 17. Methodology of tests should be well accepted and in use throughout the laboratory community. 18. Contractor must provide a timeline for phase-in, delivery, and installation of proposed equipment, and training of end users. This timeline shall be included with the proposal. B. DELIVERABLES/SUPPLIES This order is for the cost per test procurement of an instrument/system for molecular diagnostic testing. Reagents and supplies will be purchased under the terms of the reagent lease agreement. 1. The Contractor shall provide supplies: reagents and consumables for the Hepatitis C and HIV Load, CT/NG, TV/MG, HIV 1/2 Qualitative, EBV, CMV and HPV testing. Additional testing may be added at the discretion of VAMC. Any additional testing shall be negotiated between the Contractor and VAMC. 2. The Contractor shall submit all invoices for review according to the established contract at the end of each billing cycle. 3. All items/equipment not to be contracted shall be specifically detailed on the invoice including description, quantity acquired, and government cost. 4. Any changes in reagents or equipment modifications shall be immediately disclosed by the Contractor electronically as well as by postal mail with supporting documentation of the change, and detailed guidance for implementation within twenty-four hours of its application. 5. Additional charges incurred by the government to provide the continuity of contracted tests to patients and not limited to outsourcing, transportation, and or any other additional cost shall be covered by the Contractor at no additional charge to the government. VII. SECURITY REQUIREMENTS: 1. Contractors or any representative of the contracted company will obtain a visitor s badge up entry of the facility for all official business. 2. Contractors or any representative of the contracted company will not remove any part of the contracted equipment containing patient data. 3. At the end of the contract, all hard drives or memory devices containing VA sensitive, or VA patient information will be removed and turned over to the VA Biomedical Service for destruction. 4. Include the security clause in the contract: General Security Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security. Access to VA Information and VA Information Systems 1. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order. 2. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures. Training 1. All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems: (a) Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the VA Rules of Behavior, Appendix E relating to access to VA information and information systems; (b) Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training; (c) Successfully complete the appropriate VA privacy training and annually complete required privacy training; and (d) Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access [to be defined by the VA program official and provided to the contracting officer for inclusion in the solicitation document e.g., any role-based information security training required in accordance with NIST Special Publication 800-16, Information Technology Security Training Requirements.] 2. The contractor shall provide to the contracting officer and/or the COTR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required. 3. Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete. VA Information Custodial Language 1. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1). 2. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated. Security Incident Investigation 1. The term security incident means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/subcontractor shall immediately notify the COTR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access. 2. To the extent known by the contractor/subcontractor, the contractor/subcontractor s notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant. Records Management All records (administrative and program specific) created during the period of the contract belong to Cincinnati VAMC and must be returned to the VAMC at the end of the contract. NO VA DATA OF ANY TYPE SHALL BE TRANSFERRED FROM THE VA. VII. CONTRACT BILLING AND PERFORMANCE MONITORING: 1. Contractor will supply COR with monthly invoice in a timely manner. 2. Contractor will agree to payment of monthly invoice via Financial Services System (FSS). 3. The COR will monitor the performance of the contract in conjunction with the Chief of Pathology & Laboratory Medicine and the supervisor of the Microbiology/Molecular area. This will occur via monitoring of Quality Control, Proficiency Testing, accuracy of invoicing, ability to meet the terms of the contract agreement, and other methods to be determined.