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4 Puget Sound Health Care System Pathology and Laboratory Medicine Microbiology Section- Janelle Lee, Microbiology Supervisor STATEMENT OF WORK FOR AUTOMATED REAL TIME PCR PLATFORM SCOPE The VA Puget ... 4 Puget Sound Health Care System Pathology and Laboratory Medicine Microbiology Section- Janelle Lee, Microbiology Supervisor STATEMENT OF WORK FOR AUTOMATED REAL TIME PCR PLATFORM SCOPE The VA Puget Sound Health Care System (VAPSHCS) Pathology and Laboratory Medicine Service is requesting reagents and supplies as part of a Cost Per Test Rental (CPT/CPRR). This testing is for veterans across Washington State, Oregon, Alaska and Bone Marrow and Solid Organ Transplant patients tested and monitored from across the United States. These large volume random-access molecular analyzers perform Hepatitis B (HBV) viral load, Hepatitis C (HCV) viral load, Human Immunodeficiency virus (HIV) viral load, Cytomegalovirus (CMV) viral load, Epstein-Barr virus (EBV) viral load and Human polyomavirus 1 (BK) quantitative assays. For qualitative assays, the analyzers perform sexually transmitted infection (STI) testing for Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, Mycoplasma genitalium (CT/NG/TV/MG) and High-Risk Human Papillomavirus (HR HPV) as well as qualitative testing for Herpes Simplex Virus 1 and 2 (HSV-1 & HSV-2) and Varicella Zoster Virus (VZV). For upper respiratory infections, the analyzers perform SARS-CoV-2 (COVID-19) and 4-Plex testing of COVID-19, Influenza A, Influenza B and RSV. The platform uses nucleic acid (NAT) testing analysis/assays The analyzer must have minimal maintenance and allow for streamlined workload management with continuous access to reagents, samples and supplies without interrupting processing. Products numbers requested are Brand Name or Equal to Abbott Alinity m automated molecular platform. The required testing can detect and quantitate low levels of RNA or DNA, which is important in monitoring the effectiveness of therapy, to detect an infection sooner or for early diagnosis of a communicable disease. This agreement is to also include any new assays that become available on the platform. MENU/ESTIMATED VOLUME The following assays will be required to run as a single or combined NAT-based assay using a random-access analyzer on a primary or aliquoted sample tube as specified below. Testing numbers may increase by up to 5% each year. Refer to Price List for required reagents and consumables with estimated annual volume. GENERAL REQUIREMENTS The analyzer should be an automated NAT Analyzer, utilizing real time PCR technology. The vendor shall provide an analyzer with the most current version of software and hardware. The vendor shall provide the facility with Food and Drug Administration (FDA) approved analyzer/equipment, reagents, controls, calibration materials, disposables, and all consumable parts necessary for analyzer operation. Also provide electronic operating manuals, technical/service manuals, troubleshooting guide, Safety Data Sheets (SDS), preventive maintenance guide, and record logs. The vendor shall provide/install any routine and special items required to operate/maintain the equipment/analyzer in optimal condition such as but not limited to printer, UPS, and surge suppressors. The cost of these items shall be incorporated in the price proposal. EQUIPMENT FUNCTIONALITY/SALIENT CHARACTERISTICS (GENERAL) Random access for load on the go testing without the need to batch. Time to first result of less than 115 minutes. Throughput of 300 results in approximately 8 hours; up to 1080 results in 24 hours Onboard capacity of up to 20 assays at any one time Ability to run STAT samples Universal sample racks to mitigate sample sorting and batching and primary bar-coded sample tubes can be utilized On-board reagent stability of up to 30 days with no on-board refrigeration required for reagents 4 Assay Processing Units ( APUs ) on board minimizing complete instrument down time External calibration curves valid for up to 6 months; calibrators only needed for quantitative assays No daily maintenance requirements All assays run on a 24-hour time-based QC strategy Load up capacity to facilitate walk-a-way capabilities. Ability to add additional assays and newly developed assays at a later date. Systems shall be able to analyze serum, plasma, urine, emulsified swab exudates and sample aliquots. Have Bar-code capabilities for reagents, controls, calibrators, patient samples and inventory management to include data archiving and active reagent volume monitoring and warning. Shall utilize and read samples with barcode types with or without bar-code languages, with Check digits/sums. The platform shall read the following bar code types: Code 128, Code 39, Code 120, Interleaved 2 of 5, Code 93. Waste disposal of liquids output shall have onboard liquid waste containers. The analyzer must have a quality control program for all assays, which includes at a minimum: Interactive, On-board quality control (QC) package. Ability to evaluate and print QC results while the instrument is analyzing patient samples. The ability to review and print daily and monthly results. Computer print-out capability for calibrators, controls, patient results, and assay repeats. The analyzer must have positive specimen and reagent identification to reduce possible sources or error/delay and to improve laboratory efficiency. The analyzer must be able to store and retransmit results in case of interface downtime. Interfacing requirements to be provided by the vendor: Instrument HIS/LIS physical connection and translation (drivers). Shall provide bidirectional interface capability (broadcast download and host query). Any additional hardware and software needed to interface the analyzer and technical assistance with interfacing the analyzer Assays that have had FDA cleared testing methodologies assigned to them by the FDA must utilize the FDA cleared technology for the assay. If assays are FDA cleared that technology or comparable technology must be utilized by the considered platform. The ability to establish a laboratory-developed test (LDT) using the molecular instrument with lab-specific reagents and parameters must be available through LDT system capability. INSTALLATION AND VALIDATION The vendor shall provide at installation/set-up and when bringing new tests on-line, a technical support specialist who shall assist in the performance/validation studies including: installation/set-up, correlation studies (evaluation/comparison data sufficient to satisfy CAP standards), staff training, in-services to laboratory personnel and clinicians, and assist with any methodology problems and questions. This service shall be available during regular office hours on a 5 days/week basis. Throughout the life of the agreement, the vendor shall provide assistance to the user in setting up and maintaining/trouble shooting user-defined assays as additional tests are brought in-house. SERVICE AND MAINTENANCE Instrument support service shall provide assistance with troubleshooting and repair of the analyzers. On-site service shall be available Monday through Friday during regular business hours (8am-5pm). The support service shall follow-up all down time calls within 1 hour. In the event of a failure to perform the vendor agrees, with the service agreement in force, to facilitate instrument repair, if deemed necessary outside the Monday through Friday window stated in #1 above. Uptime Guarantee: Contractor shall agree that all equipment provided under the agreement shall be operable and available for use 98% of the time. Operational time is considered 8-5, M-F. Downtime shall be computed from time the contractor is notified of the incident. The vendor shall provide a twenty-four hour/seven-day service hotline with technical support. The vendor shall provide a preventative maintenance schedule to include timely scheduled vendor preventative maintenance visits as required. The vendor shall provide standard and routine software and hardware upgrades to the equipment hardware and operating systems, without additional charge (e.g. upgrades that correct or improve either the mechanical operations or software of the system and would keep the instrument performing optimally). The vendor shall define daily, weekly, monthly, and as needed maintenance and the time required to perform each maintenance task. The vendor shall indicate which tasks are user level and which are service level. Vendor required service will be scheduled in such a manner as to minimize disruptions to day-to-day operations. INSTRUMENTATION AND SOFTWARE 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. The vendor shall provide all upgrades to the equipment hardware, software, and operating systems without additional charge to the Government. 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 BPA satisfactorily to the user. 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 the 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. 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 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 TRAINING The contractor shall provide an instrument training program that is coordinated with and timely to the equipment installation. This shall include training on the operation of the system, data manipulation, and basic trouble shooting and repair. Onsite training shall be provided by Contractor during the installation process for a technical representative. EVALUATION CRITERIA FOR EXISTING ON-BOARD INDIVIDUAL ASSAY REQUIREMENTS. BK Quantitative assay for BK virus must have plasma and urine as available sample types for analysis. The calibration system shall utilize not less than 2 assay calibrators to generate a calibration curve in replicates of 3 that can be stored from run to run. There must be an internal control used during extraction and detected at all levels. CMV CMV primers must be aligned with the World Health Organization (WHO) standard. The specimen requirement must be human plasma (EDTA). The assay must target sequences within the UL34 and UL80.5 genes of the CMV genome to ensure built-in assay redundancy and target regions are highly conserved. The calibration system shall utilize not less than 2 assay calibrators to generate a calibration curve in replicates of 3 that can be stored from run to run. The sensitivity of the platform must be a minimum claimed limit of detection (LOD) of 10 IU/mL and a lower limit of linearity/quantification (LLOQ) of 30 IU/mL. There must be an internal control used during extraction and detected at all levels. EBV Assay is standardized to the 1st World Health Organization (WHO) International Standard for Epstein-Barr Virus for Nucleic Acid Amplification Techniques Ability to test Cytomegalovirus (CMV) and Epstein-Barr Virus (EBV) from a single sample, which is critical for transplant patients who are at risk of developing coinfections There must be an internal control used during extraction and detected at all levels. HBV The platform selected must accurately quantify all HBV Genotypes in both plasma and serum The platform assay may not be impacted by YMDD mutants, HBsAg escape mutants, or drug-resistant mutants The calibration system shall utilize not less than a 2-point external calibration to generate a calibration curve that can be stored from run to run. Sensitivity shall be a minimum of 30 IU/mL (0.5 mL input) \Upper limit of quantification should be 1,000,000,000 IU/mL, or greater. There must be an internal control used during extraction and detected at all levels. HCV HCV assay must have confirmatory and monitoring claims for initial confirmation and diagnosis. The calibration system shall utilize not less than a 2-point external calibration to generate a calibration curve that can be stored from run to run. Platform sensitivity must not be any higher than 30 IU/mL There must be an internal control used during extraction and detected at all levels. HIV-1 HIV assay must have confirmatory and monitoring claims for initial confirmation and diagnosis. The platform specimen input must have multiple sample input volumes, which may include 1.0 mL or less. The platform subtype analysis should include Group M subtypes A-H, Group O and Group N in plasma. The platform target region must be targeted to the integrase region of the polymerase gene. The calibration system shall utilize not less than a 2-point external calibration to generate a calibration curve that can be stored from run to run. The sensitivity of the platform must be a minimum of 40 copies/mL for 1.0mL or less. There must be an internal control used during extraction and detected at all levels. The HIV-1 Assay should be 100% specific. HPV HPV assay must have primary screening indication. HPV assay must have unique evidence-based risk stratification by separately reporting HPV genotypes 16, 18 and 45. Two pools of all remaining high-risk genotypes (Group A: 31/33/52/58 and Group B: 35/39/51/56/59/66/68) in one single reaction, with each group separately reported Gynecologic samples collected using Hologic ThinPrep collection devices must be an FDA Cleared sample type. There must be an internal control used during extraction and detected at all levels, as well as a cellular control for sample quality. HSV 1&2 AND VZV HSV 1 & 2 / VZV assay provides qualitative detection and differentiation of Herpes Simplex Virus 1 (HSV-1), Herpes Simplex Virus 2 (HSV-2) and Varicella Zoster Virus (VZV) DNA from clinician-collected cutaneous or mucocutaneous lesion swab specimens. Lesion swab specimens, including cutaneous and mucocutaneous, may be collected in various commercially available viral transport media (VTM) (Copan UTM®, BD UVT, Remel M4RT®). There must be an internal control used during extraction and detected at all levels. SARS-COV-2(COVID-19), INFLUENZA A & B AND RSV COVID-19 may be acquired alone as a single assay, with corresponding assay-specific reagents. Respiratory 4-plex for COVID-19, Influenza A, Influenza B and RSV assay has ability to mask and unmask results based on the analytes ordered. Results not initially ordered can be recalled and resulted within 14 days of testing specific to the patient without recalling the sample or the patient. There must be an internal control used during extraction and detected at all levels. STI Must have FDA Cleared 4-in-1 STI testing for CT/NG/TV/MG, enabling up to 4 results in a single analysis. The sample collection system must utilize a single collection device for all FDA Cleared sample types and be approved for urine, throat, vaginal, rectal collection sites. Gynecologic samples collected using Hologic ThinPrep collection devices must be an FDA Cleared sample type. There must be an internal control used during extraction and detected at all levels, as well as a cellular control for sample quality. STI-4-Plex assay has ability to mask and unmask results based on the analytes ordered Results not initially ordered can be recalled and resulted within 14 days of testing specific to the patient without recalling the sample or the patient. Testing must remain compatible with the current laboratory developed test (LDT) held by Seattle VA Puget Sound Healthcare System. This LDT is for self-collected throat and rectal swab samples in a clinical or non-clinical setting. Requirements are as follows: that the Abbott Alinity m multi-Collect specimen collection kit is used, that the Abbott Alinity m instrument is used, that the Alinity m STI CTRL and STI AMP kits are used with accompanying Alinity m consumables and that testing must occur within the Molecular section of the Microbiology Laboratory at Seattle VA Puget Sound. SUPPLIES REQUIRED TO MEET AGENCY S NEEDS Brand name or equal reagents and supplies are required for continuation of patient care. The Seattle VA Puget Sound Medical Center laboratory requires the procurement of reagents, supplies and instrumentation to continue to provide the following infectious disease molecular assays: Hepatitis B (HBV) viral load, Hepatitis C (HCV) viral load, Human Immunodeficiency virus (HIV) viral load, Cytomegalovirus (CMV) viral load, Epstein-Barr virus (EBV) viral load and Human polyomavirus 1 (BK) quantitative assays. For qualitative assays, the analyzers perform sexually transmitted infection (STI) testing for Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, Mycoplasma genitalium (CT/NG/TV/MG) and High-Risk Human Papillomavirus (HR HPV) as well as qualitative testing for Herpes Simplex Virus 1 and 2 (HSV-1 & HSV-2) and Varicella Zoster Virus (VZV). For upper respiratory infections, the analyzers perform SARS-CoV-2 (COVID-19) and 4-Plex testing of COVID-19, Influenza A, Influenza B and RSV. The following reagents and supplies are required for these assays. Product Description Product Description Alinity m HIV-1 CAL Kit Alinity m EBV CAL Kit Alinity m HIV-1 CTRL Kit Alinity m EBV CTRL Kit Alinity m HIV-1 AMP Kit Alinity m EBV AMP Kit Alinity m HBV CAL Kit Alinity m CMV CAL Kit Alinity m HBV CTRL Kit Alinity m CMV CTRL Kit Alinity m HBV AMP Kit Alinity m CMV AMP Kit Alinity m HCV CAL Kit Alinity m LRV Tube Alinity m HCV CTRL Kit Alinity m Transport Tube Pierceable Capped Alinity m HCV AMP Kit Alinity m Transport Tube Alinity m Sample Prep Kit2 Alinity m Pierceable Cap Alinity m HR HPV CTRL Kit Alinity m Aliquot Tube Alinity m HR HPV AMP Kit US Alinity m Specimen Dilution Kit 1 Alinity m STI CTRL Kit Alinity m HSV 1 & 2 / VZV CTRL Kit Alinity m STI AMP Kit Alinity m HSV 1 & 2 / VZV AMP Kit Alinity m Sample Prep Kit 1 Abbott Universal Collection Kit Alinity m multi-Collect Specimen Collection Kit Alinity m SARS-CoV-2 CTRLKit Alinity m Lysis Solution SARS-CoV-2 CTRLKIT - 510k Alinity m Ethanol Solution Alinity m SARS-CoV-2 AMP Kit Alinity m Diluent Solution SARS-CoV-2 AMPKIT - 510k Alinity m Vapor Barrier Solution Alinity m Resp-4-Plex CTRL Kit - 510k Alinity m Bottle for Ethanol Use Alinity m Resp-4-Plex CTRL Kit Alinity m Pipette Tips, 50uL Alinity m Resp-4-Plex AMPKit - 510k Alinity m Pipette Tips, 1000uL Alinity m Resp-4-Plex AMPKit Alinity m Integrated Reaction Units (IRU) Alinity m Urine Transport Kit Alinity m Waste Box Alinity m BKV CAL Alinity m Handheld Barcode Scanner Alinity m BKV CTRL Alinity m Universal Sample Rack Alinity m BKV AMP Kit Alinity m Sample Rack Holder Universal Collection Kit - 510k Alinity m IRU Waste Container Alinity m Simpli Collect Urine & Swab kits Period of Performance Base Year: 12/1/2025 to 11/30/2026 Option Year One: 12/1/2026 to 11/30/2027 Option Year Two: 12/1/2027 to 11/30/2028 Option Year Three: 12/1/2028 to 11/30/2029 Option Year Four: 12/1/2029 to 11/30/2030

Inactive

Molecular Infectious Tests for Seattle VA Medical Center.