6640--Cost-Per-Test (CPT) autoimmune analyzer testing system

Pre-Solicitation This is a Pre-Solicitation for commercial items prepared in accordance with the format in Subpart 12.6 as supplemented with additional information included in this notice. THIS PRE-SOLICITATION NOTICE IS NOT A REQUEST FOR A QUOTE (RFQ). VENDORS SHOULD NOT SUBMIT FORMAL QUOTES UNTIL THE RFQ IS POSTED ON THIS WEBSITE. This notice is not to be construed as a commitment by the Government nor will the Government pay for the information resulting from this posting. The Department of Veterans Affairs (VA), Veterans Integrated Service Network (VISN 8), James A. Haley Veterans Hospital (JAHVH), Tampa, FL, intends to issue a Request for Quote (RFQ), brand name or equal to BioPlex 2200 Instrument System, MPN 660000, with UPS Back-Up System, MPN 660-0517, including service & maintenance, supplies/consumables included in price of reagents. The applicable North American Industry Classification System (NAICS) code assigned to this procurement is 334516-Analytical Laboratory Instrument Manufacturing with 1000 employees. See below specifications: Brand name or equal. The contractor shall provide an FDA-approved, fully automated, and integrated analyzer testing system, printer, computer, Uninterruptable Power Supplies (UPS) for the analyzer, and accessories required for equipment usage. Below are the salient characteristics of the autoimmune FDA-approved instrument and FDA-approved reagents capable of performing ANA; Vasculitis; Anti-CCP IgG; APLS IgA-IgG-IgM; EBV IgG-IgM; HSV ½; Celiac IgA-IgG; MMRV IgG; Syphilis Total & RPR; and Lyme testing with specific functionality and performance-based requirements of the system: General instrument characteristics include the ability to run FDA-approved patient testing for 100% of the below-listed tests on an FDA-approved, fully automated, random access, testing platform with priority processing: Brand: BioRad Laboratories Inc. Test Base Year Estimated Test Volume ANA 3,600 VASCULITIS 800 ANTI-CCP IgG 1,500 APLS IgA 600 APLS IgG 600 APLS IgM 600 EBV IgG 600 EBV IgM 600 HSV 1/2 1200 CELIAC IgA 2,500 CELIAC IgG 2,500 MMRV IgG 2,000 SYPHILIS TOTAL & RPR 6,500 LYME 600 a. Sufficient capacity and throughput to meet the volume and service demands as defined in the tests and volumes listed in section a. above. b. Bar-coded primary patient sample tube entry capabilities. c. Ability to run multiple assay protocols simultaneously. d. Contractor shall provide all necessary software and hardware for the systems valid, acceptable, bidirectional interface data transmission through Data Innovation (DI) Instrument Manager (IM) middleware network connections. e. Contractor shall provide all necessary system interface hardware and software upgrades as required for VA network compliance. f. Contractor shall provide all upgrades to the equipment hardware and operating system software. g. Operator and Service Manual shall be furnished with each model supplied. Electronic formats are acceptable. h. Procedures shall be provided in accordance with the Clinical and Laboratory Standards Institute (CLSI) in editable format. i. Contractor to provide all test kits, reagents, calibrators, controls, supplies, consumables, and Contractor assistance required for any instrument and method validations. j. Additional testing may be added in support of patient care needs as determined by care providers. k. Computer systems (CPUs, Monitors, Keyboards, Printers), and UPSs provided by the Contractor for the instrument throughout the contract period. l. Our laboratory working space dimensions in inches ( ) are listed below. The contractor s analyzer system must fit within the space listed below: i. 53 Height x 51 Width x 34 Depth. m. Electrical Characteristics: i. 100-240 VAC at 50-60Hz, 1000 Watts. DELIVERABLES: Brand name or equal to BioPlex 2200 Instrument System, MPN 660000 with UPS Back-Up System, MPN 660-0517, including service & maintenance, supplies/consumables included in the price of reagents, Description - Kits, Controls, Calibrators, and Accessories Unit Qty ANA Screen Reagent Pack 100 Tests Pack 52 BioPlex 2200 Vasculitis Kit 100 Tests Kit 11 BPX Anti CCP IgG 100T Kit Kit 27 BioPlex 2200 APLS IgA Reagent Pack 100 Tests Pack 12 BioPlex 2200 APLS IgG Reagent Pack 100 Tests Pack 14 BioPlex 2200 APLS IgM Reagent Pack 100 Tests Pack 14 BioPlex 2200 EBV IgG Reagent Kit 100 Tests Kit 12 BioPlex 2200 EBV IgM Reagent Kit 100 Tests Kit 13 BioPlex 2200 HSV 1/2 Reagent Kit 100 Tests Kit 13 BioPlex 2200 Celiac IgA Reagent Kit 100 Tests Kit 38 BioPlex 2200 Celiac IgG Reagent Kit 100 Tests Kit 31 BioPlex 2200 MMRV IgG 100 Tests Each 90 Syphilis Total & RPR Reagent 100 Tests Each 55 BPX 2200 Lyme Total 200 Tests Each 6 Reaction Vessel (1000) Box 21 Bio-Hazard bag 14x19 Each 23 Instrument Sheath Fluid Box Box 13 BPX 2200 Wash Buffer Each 26 BPX Detector Calibration Pack Each 7 Instrument Detector Clean Pack Each 7 Instrument Probe Cleaning Each 7 Sodium Hydroxide 1.0N Liter Each 1 ANA Specific IgG Cal Kit Kit 7 ANA Specific IgG Control Set Kit 7 BioPlex 2200 Vasculitis Calibrator Kit Kit 7 BioPlex 2200 Vasculitis Control Set Kit 7 Anti CCP Calibrator Set Kit 7 Anti CCP Control Set Kit 7 Cal Set, Celiac IgA, BPX Kit 7 Ctrl, Set, Celiac IgA, BPX Kit 7 Cal Set, Celiac IgG, BPX Kit 7 Ctrl, Set, Celiac IgG, BPX Kit 7 BioPlex 2200 APLS IgA Calibrator Set (3 vials) Pack 13 BioPlex 2200 APLS IgA Control Set (6 vials) Pack 7 BioPlex 2200 APLS IgG Calibrator Set (7 vials) Pack 13 BioPlex 2200 APLS IgG Control Set (6 vials) Pack 7 BioPlex 2200 APLS IgM Calibrator Set (7 vials) Pack 13 BioPlex 2200 APLS IgM Control Set (6 vials) Pack 7 BioPlex 2200 EBV IgG Calibrator Set Kit 8 BioPlex 2200 EBV IgG Control Set Kit 8 BioPlex 2200 EBV IgM Calibrator Set Kit 7 BioPlex 2200 EBV IgM Control Set Kit 7 BioPlex 2200 HSV 1/2 Calibrator Set Each 7 BioPlex 2200 HSV 1/2 Control Set Each 7 BioPlex 2200 MMRV IgG Calibrator Set Each 7 BioPlex 2200 MMRV IgG Control Set Each 7 Syphilis Total & RPR Calibrator Set Each 7 Syphilis Total & RPR Control Set Each 7 BioPlex Sample Dilution Buffer, 120 mL Each 5 BPX 2200 Lyme Total Calibrator Set Each 4 BPX 2200 Lyme Total Control Set Each 2 FUNCTIONAL AND PERFORMANCE CHARACTERISTICS: Must provide the following functional and performance capabilities to ensure equipment is utilized and maintained according to the requirements of the system: a. Preventive Maintenance shall be performed per manufacturer s guidelines. b. Instrument service to be provided during routine business hours. Certain circumstances may dictate the need for repair service to be conducted outside routine business hours. All such arrangements will be coordinated between the contractor and VA laboratory personnel. c. Expected response to service call time from initial call to Contractor to service engineer arriving on site should be no more than 24 hours. d. Technical Support Hotline must be available for in-house troubleshooting. The actual Solicitation #36C24824Q0526 is anticipated to be posted to the Beta.SAM.gov website on or about 02/23/2023, closing date of 02/29/2023 @10am EST. Quoters should continue to monitor Beta.SAM.gov for the RFQ and any subsequent Amendments to that RFQ. All Quoters must be registered in the System for Award Management (SAM) database; see https://www.sam.gov for complete online Reps and Certs. SDVOSBs must be certified and verified in VetBiz. The point of contact is Leonora Simmons, Contract Specialist, email: leonora.simmons@va.gov