6640--Real time CMV amplification reagent testing with CMV control and calibrator kits.

4 SOURCES SOUGHT The Seattle VA Medical Center is issuing this sources sought as a means to conducting market research to identify parties having an interest in and the resources to support a requirement of the Abbott M2000 CMV reagents, consumables and supplies for a base period and 4 option years. The purpose of this Sources Sought Announcement is for market research to make appropriate acquisition decisions and to gain knowledge of potential qualified sources for the Abbott M2000 CMV Reagents, Consumables and Supplies listed below. This is not a request for quotations. The Department of Veterans Affairs, NCO20 is looking for sources of the following: HIV IVD 06L18-090 HIV-1 Reagent Kit 06L18-080 HIV-1 Control Kit 06L18-070 HIV-1 Calibrator Kit HIV IVD 01N30-090 REALTIME HCV QUANT IVD 01N30-080 HCV CONTROL KIT 01N30-070 HCV CALIBRATOR KIT HCV GT IVD 02N40-091 RealTime HBV Amplification Kit, US 02N40-080 REALTIME HBV CONTROL KIT US 02N40-070 REALTIME HBV CALIBRATOR KIT, US HBV IVD

02N40-091 RealTime HBV Amplification Kit, US 02N40-080 REALTIME HBV CONTROL KIT US 02N40-070 REALTIME HBV CALIBRATOR KIT, US CT/NG IVD 08L07-091 RealTime CT/NG II Amp KitUS 08L07-080 RealTime CT/NG Control Kit 09K12-004 Abbott multiColl Kit US Pierc Cap CMV IVD 09N21-090 RT PCR CMV QUANT RGT 09N21-080 CMV Control Kit 09N21-070 CMV Calibrator Kit M2000 Sample Preperation & Consumables 06K12-024 Sample Prep GPR Pack DNA 04J70-024 Sample Prep GPR Pack RNA 03L78-061 Proteinase K, Recombinant, PCR Grade 04J71-010 1000ul Pipette Tip 04J71-017 200ul Pipette Tip 04J71-020 Reaction Vessels 04J71-060 200mL Reagent Vessel 04J71-030 96 Deep Well Plate 04J71-070 96-Well Reaction Plate 04J71-075 Optical Seal 04J71-080 Master Mix Tubes SCOPE The VA Puget Sound Health Care System (VAPSHCS) Pathology and Laboratory Medicine Service is requesting reagents as part of a Cost Per Test Rental (CPT/CPRR) for an analyzer that performs Hepatitis B (HBV) Hepatitis C (HCV)viral load and HCV genotyping analysis, Human Immunodeficiency virus (HIV) viral load, Chlamydia and Gonorrhea (CT/GC) testing and Cytomegalovirus (CMV) viral load. The platform uses nucleic acid (NAT) testing analysis/assays. Seattle VAPSHCS Lab requirement is for RealTime CMV Amplification Reagent testing with CMV Control and Calibrator kits. The analyzer must have minimal maintenance and allow for streamlined workload management with continuous access to reagents, samples and supplies. Products numbers requested are Brand Name or Equal to Abbott m2000 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. At any time during purchase agreement, the VAPSHCS may trade in one (1) of the current m2000 sp/rt systems for one (1) Next Generation Molecular Technology with no increase in equivalent reagent pricing. MENU/ESTIMATED VOLUME The following assays will be required to run a single, NAT based, walk away or random-access analyzer as specified below. Testing numbers are may increase by up to 5% each year. See schedule of items for required Reagents. Required consumables and are listed in the quote document attached to this SOW. GENERAL REQUIREMENTS The analyzer should be an automated NAT Analyzer, utilizing real time PCR technology. The analyzer should be a wheel equipped, floor standing analyzer, with specimen tracking software. Physical dimensions (H x W x D) of no more than 60 x 60 x 34 . Analyzer shall accept the following sample tubes: Height 72-102mm, Diameter 8.25-16.1 mm. Power Requirements: 110-120 volts with 20 amps. 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 any consumable parts necessary for analyzer operation. Also provide electronic operating manuals, technical/service manuals, troubleshooting guide, Material Safety Data Sheets (MSDS), 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, drainage systems, UPS, and surge suppressors. The cost of these items shall be incorporated in the price proposal. EQUIPMENT FUNCTIONALITY/SALIENT CHARACTERISTICS (GENERAL) The analyzer must have a robotic sample handler that includes the following: Automatic reloading of a unique pipet tip for each sample assayed. Load up capacity to facilitate walk-a-way capabilities. Ability to add additional assays and newly developed assays at a later date. System shall be able to analyze serum, plasma, urine and emulsified swab exudates. 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 container. 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 run new and old lot numbers of QC concurrently for parallel testing. 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 10. The platform will allow for Open Mode Flexibility Flexible protocols available for various sample types and volumes, including RNA, DNA and Total Nucleic Acid protocols. For any Analyte Specific Reagent (ASR) testing or Research Use Only (RUO) testing the platform must provide flexibility, to include PCR applications using multiple probe design technologies. 11. Assays that have had FDA cleared testing methodologies assigned to them by the FDA must utilize the FDA cleared technology for the assay. For example, the following assays may or may not be FDA cleared. If assays are FDA cleared that technology or comparable technology must be utilized by the considered platform. 12. The extractor must allow access to the patient samples within 1⁄2 hour after the extraction process begins. INSTALLATION AND VALIDATION Vendor shall move instruments, free of additional charge, to final testing location upon completion of validation process. Vendor shall provide the facility with all cross-over supplies and reagents needed at installation and during training of staff. 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 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. 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). Vendor shall define daily, weekly, monthly, and as needed maintenance and the time required to perform each maintenance task. 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. 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. Thereafter, the Contractor shall provide off-site training for two operators at the Contractor s training facility. A training program that involves off-site travel shall include the cost of airfare, room and board for each participant. Onsite training shall be provided by Contractor during the installation process for a technical representative. EVALUATION CRITERIA FOR EXISTING ON-BOARD INDIVIDUAL ASSAY REQUIREMENTS. HIV 1. The platform specimen input must have multiple sample input volumes, which may include 1.0 mL or less. 2. The platform subtype analysis should include Group M subtypes A-H, Group O and Group N in plasma. 3. The platform target region must be targeted to the integrase region of the polymerase gene. 4. Thermocycling should be a low temperature PCR reaction 40 degrees C. 5. The control system shall not exceed 3 controls per batch of 21 to 93 patient specimens. 6. 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. 7. The sensitivity of the platform must be a minimum of 40 copies/mL for 1.0mL or less. 8. The standard deviation (SD) should not exceed of 0.25 log copies/mL 9. There must be an internal control added to lysis buffer during extraction and detected at all levels. 10. The platform must discriminate the following subtypes of HIV-1 virus: Group M, Group O, and Group N, delivering reliable results for patient management. Abbott accomplishes this through the assay design incorporating a novel partially double stranded probe design, which tolerates the genetic diversity of HIV-1, leading to reliable HIV-1 results. 11.The platform linear range of 40, or less, copies/ml to 10 million copies/ml at the upper levels of the analytical measurement range (AMR). 1. Platform sensitivity should be able to discriminate Group M, Group N, and Group O at a 100% level. 12. The real time PCR HIV-1 Assay should be 100% specific. 13. Freshly drawn specimens (whole blood) should be capable of being held at 15-30°C for up to 6 hours or at 2-8°C for up to 24 hours, prior to centrifugation, and testing. HCV The proposed platform for HCV genotype detection should accurately quantify all HCV genotypes, 1,2,3,4 and 5 genotypes in both plasma and serum and be FDA approved. Cycling conditions Thermocycling should be a low temperature PCR reaction 40 degrees C. 3. The control system shall not exceed 3 controls per batch of 21 to 93 patient specimens. 4. 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 12 IU/mL Linear Range must be no less than 12 IU/mL to 100 million IU/mL or greater. 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 control system shall not exceed 3 controls per batch of 21 to 93 patient specimens. 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 10 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 added to lysis buffer during extraction and detected at all levels. CT/NG The targeted section of the must include Cryptic Plasmid on the Chlamydia trachomatis organism and Opa gene of the Neisseria gonorrhea organism The sample collection system must utilize a single collection device for all FDA Cleared sample types and be approved for urine, throat, vaginal and rectal collection sites. 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 control system shall not exceed 3 controls per batch of 21 to 93 patient specimens. 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 31.20 IU/mL and a lower limit of linearity/quantification (LLOQ) of 50 IU/mL. The standard deviation (SD) should not exceed of 0.3 log IU/mL There must be an internal control added to lysis buffer during extraction and detected at all levels. The platform linear range of 50, or less, IU/mL to greater than 1 million IU/mL at the upper levels of the analytical measurement range (AMR) Potential sources shall provide, at a minimum, the following information to Point of Contact listed below: 1) Company name, address, and point of contact, phone number, e-mail address, and DUNS. 2) Please identify your company s size in comparison to the anticipated North American Industry Classification System (NAICS) code 325413 In-Vitro Diagnostic Substance Manufacturing. To be considered a small business your company must have fewer than 1,250 employees. 3) Any Service Disabled Veteran Owned Small Businesses or Veteran Owned Small Businesses who responds to a solicitation on this project must be registered with the Department of Veterans Affairs Center for Veterans Enterprise VetBiz Registry located at http://vip.vetbiz.gov. 4) The Non-Manufacturer Rule (NMR) will apply if there is a decision to set-aside the procurement. 5) Potential sources shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor or authorized reseller for the proposed equipment/system such that OEM warranty and service are provided and maintained by the OEM. All software licensing, warranty, and service associated with the equipment/system shall be in accordance with the OEM terms and conditions. This procurement is for new products ONLY; no remanufactured or "gray market" items. All products must be covered by the manufacturer's warranty. Responses are due by 5/4/2020 10:00 AM PST, to the Point of Contact. The Government is not obligated to nor will it pay for or reimburse any costs associated with responding to this source sought notice. This notice shall not be construed as a commitment by the Government to issue a solicitation or ultimately award a contract, nor does it restrict the Government to a particular acquisition approach. The Government will in no way be bound to this information if any solicitation is issued. Notice to Potential Offerors: All Offerors who provide goods or services to the United States Federal Government must be registered in the System Award Management (SAM located on the web at www.sam.gov). It is desirable that any Offeror to have completed their business Online Representations and Certifications Application in the System for Award Management (SAM). Point of Contact: Ty Draszt, Contract Specialist Ty.Draszt@va.gov, 360-553-7612