Chemical Analyzer

PURPOSE: The purpose of the sources sought is to identify available authorized businesses to provide the required product or an - or equal product. This sources sought notice is for informational and planning purposes only. Pricing information is not being requested at this time. It does not constitute a solicitation and is not to be considered as a commitment by the Government. REQUIREMENT: This notice is issued by the U.S. Air Force, 92d Contracting Squadron, Fairchild AFB, WA. This sources sought is seeking to identify responsible potential sources to provide one (1) ) automated clinical chemistry laboratory analyzer that is compatible with customer's existing supplies, reagents and materials, that will perform 236 cost-per-tests a day and provide cost-per-test supplies, maintenance and technical support services. It is currently believed that the only SAM registered business able to provide the requirement is Clinical Diagnostics Corporation. Salient characteristics are as follows: Chemistry Analyzer Model# Vitros 4600 Vitros MicroSlide Model: Vitros Chemistry Products 819 6057 Albumin (ALB) 105 3180 Alk Phos (ALKP) 165 5281 ALT 811 2724 Amylase 843 3815 AST 838 3051 BuBc 810 2204 BUN 145 0261 Calcium (Ca) 826 2396 Carbon Dioxide (ECO2) 684 4471 Chloride (Cl-) 166 9829 Cholesterol (CHOL) 680 2584 Creatinine (CREA) IDMS TRACEABLE 680 1895 Direct HDL (dHDL) 825 7289 GGT 170 7801 Glucose (GLU) 192 1204 Magnesium (Mg) 151 3209 Phosphorus 815 7596 Potassium (K+) 837 9034 Sodium (Na+) 815 9931 Total Bilirubin (TBIL) 839 2292 Total Protein (TP) 133 6544 Triglycerides 194 3927 Uric Acid Vitros MicroTip Model: Vitros Chemistry Products 680 2314 d%A1C Reagent 680 1740 mALB Reagent Vitros Miscellaneous Fluids/Reagents Model: Vitros Chemistry Products Consumables Model: FS Reference Fld, Calibrators, Diluents, Desiccant Packs, Accessories 680 2245 AT Seismic Anchorages 188 2208 Calibrator Kit 1 166 2659 Calibrator Kit 2 129 0709 Calibrator Kit 3 120 4668 Calibrator Kit 4 114 9764 Calibrator Kit 5 114 9764 Calibrator Kit 6 132 0498 Calibrator Kit 7 857 8163 Calibrator Kit 8 856 8040 Calibrator Kit 9 680 0189 Calibrator Kit 10 680 1696 Calibrator Kit 11 680 1697 Calibrator Kit 12 680 1698 Calibrator Kit 13 680 1699 Calibrator Kit 14 680 1700 Calibrator Kit 16 680 1701 Calibrator Kit 17 680 1702 Calibrator Kit 18 680 1703 Calibrator Kit 19 680 1704 Calibrator Kit 20 680 1705 Calibrator Kit 21 680 1706 Calibrator Kit 22 680 1707 Calibrator Kit 23 680 1708 Calibrator Kit 24 680 1896 Calibrator Kit 25 680 2304 Calibrator Kit 26 680 2342 Calibrator Kit 27 680 2323 Calibrator Kit 28 680 2344 Calibrator Kit 29 680 2562 Calibrator Kit 30 680 2310 Calibrator Kit 99 807 4452 Citric Acid Solution 125 0232 Desiccant Pack 680 2095 FS Adapter for Micro Sample Cups 680 1967 FS Air Filter 680 1876 FS Assay Data Disk 680 1966 FS Assay Disposal Liner 680 1873 FS Calibrator 1 807 4452 Citric Acid Solution 680 1422 FS Cuvettes 680 1752 FS Diluent Pack 1 (Apo Diluent/UED) 680 1753 FS Diluent Pack 2 (BSA/Saline) 680 1754 FS Diluent Pack 3 (Specialty Diluent/Water) 680 2326 FS Diluent Pack 4 (DAT Dil / DAT Dil 2) 680 1892 FS Humidification Packs 680 2219 FS MicroCollection Tube Adaptor 680 1423 FS MicroTips 680 2120 FS Reagent Tray 680 1874 FS Reconstitution Diluent 680 1965 FS Slide Disposal Liner 680 1927 Heat Rejection Plenum 183 0033 Immuno WashFluid(250/350,950,5,1 FS,4600,5600) 680 1746 mALB Performance Verifier I 680 1747 mALB Performance Verifier II 121 3115 Micro Sample Cup 680 1755 MicroSensor Check Fluids I & II 806 7324 Performance Verifier I 823 1474 Performance Verifier II 680 1750 %A1c Performance Verifier I 680 1751 %A1c Performance Verifier II 855 9825 Specialty Diluent 811 1957 Universal Sample Tray 111 0352 Urine Electrolyte Diluent 145 1392 VITROS Pierceable Caps 680 1715 VITROS VersaTips 680 2178 5,1 FS/4600 AT ACC 826 2487 7% BSA 805 7812 950/FS Reference Fluid (950, 5,1 FS, 4600,5600) Instruments and assays are FDA approved (the contractor must provide proof of certification). Have No FDA warning letters issued over the past 24 months. Have no standby mode system, be always available/in normal operation including no manual priming, purging or tubing maintenance. Be ergonomically designed with flat touch screen monitor. Have on-board instructions, documentation and help functions. Have at least on-board test capacity of 125 reagent positions for multiple assays and up to 8940 on-board test capacity. No preparation, mixing or reconstitution required for integrated reagent packs and an on-board stability of 35 days and a shelf life of up to 18 months from date of manufacture. Have no plumbing, drains, stirring mechanisms, mixing assemblies floor vents or deionized water. Have waste contained within the system and disposed of daily. Not allow sample and/or reagent carryover by utilizing disposable tips. The system must not use reusable probes to aspirate the sample and reagent. Must be able to aspirate the sample from a track, using point in space metering. Not have dedicated reagent positions and require minimal reagent preparation. Have liquid reagents which must be capped while onboard. Run up to 10-user defined channel/assays at one time and have flexible processing for routine and STAT testing. Utilize universal sample trays which accommodate primary tubes including the following containers all of the following sample containers: 10ml, 3ml, 5mL, 2-4ml Collection Tubes, 1 ml Microtube, Microsample cup and .5ml and 2ml without adapters. Have positive patient identification via on-board barcode scanner. Have turnaround time for a single result of 2.5 to 16 minutes with an estimated throughout of approximately 845 tests per hour for chemistry assays, dependent upon test mix. .Be able to utilize Dry-Slide Technology: Direct ISE Potentiometric (Na/K/CI), Colorimetric/Rate, lmmuno-rate testing methods and use the direct ISE method to measure sodium, potassium and chloride. Have on-board dilution. Specifically, auto dilution, auto repeat and auto reflex capability. Be self-monitoring and alert operators to prompt action, avoiding testing delays. Provide sample management with clot detection, bubble detection, liquid Level-Sensing (Pressure Transducer), short-sample detection. The system must save the sample if a clot or bubble is detected during primary aspiration. Be able to determine hemolysis, icterus and turbidity levels without additional patient sample, reagents, consumables and no effect on throughput. It must flag only assays affected by the interferent. It must send flags and level to the LIS or data management system. Support multiple lots onboard and automatically switch lots when one is depleted. Offers random access and extended calibration stability with the same lot: 6months for general chemistry tests. Only calibrate assays at lot change, when critical system parts are changed due to service or maintenance, if QC results are consistently outside acceptable ranges, or when government regulations require, i.e., 6 months in US. Foot print - "no larger than exact footprint required" for analyzer, monitor, keyboard, CPU, printer. Provides Cost-Per-Test (CPT) pricing for 100% of tests listed in Appendix C. The cost-per-test price shall include costs covering: Analyzer(s) to include pre-analytical/post-analytical system. All reagents, standards, supplies, consumable/disposable items, parts, accessories and any other item required for the proper operation of the contractor's equipment and necessary for the generation of a test reportable result. This cost per test result will also encompass all costs associated with dilution; repeat and confirmatory testing required, producing a single test reportable; and include the materials and all other costs associated with quality control, calibration and correlation study testing that is prescribed by the Clinical and Laboratory Standards Institute (CLSI formerly NCCLS). All necessary maintenance to keep the equipment in good operating condition this includes both preventive maintenance and emergency repairs). The contractor shall provide all initial and new test validation reagent & materials needed to perform these tasks. Appendix B - Installation - Lab Chemistry Analyzer Installation: Placement and installation of a clinical chemistry analyzer and all equipment components inclusive, but not limited to, the entire laboratory associated mechanical, electromechanical parts and supplies. Installation shall conform to Industry Standards and shall meet or exceed with all applicable codes to include Local/State Regulations, NFPA, building codes, communications codes, and other codes for each Utility identified. The contractor shall provide the following services for staff which shall include the following tasks and those listed in detail in paragraphs 2 through 5. The contractor shall provide an Uninterrupted Power Supply (UPS) for each analyzer and must be installed in the same room, to be positioned on the analyzer's side. The UPS overall measurement and rear clearance for connection is no more than 444.5 x 741 x 130.6 cm and weigh no more than 70 kg., with a minimum clearance of 102 mm on all 4 sides for proper ventilation. This UPS is a self-operated unit that provides enough power, during a commercial power outage to the analyzer, to ensure that the chemistry analyzer system remains operational thus prevents mechanical noise of the chemistry system, therefore, producing accurate patient results. The bidding vendor/contractor shall provide the specific type of UPS required for their emergency use at the 92 MDG. Complete daily clean-up and a final (upon installation completion) clean-up of the work area. To include any need for cosmetic repairs on walls, floorings, ceiling, etc. The contractor shall provide a project manager to perform/oversee system installation, correlation, validation. The contractor shall provide all validation reagent/materials needed to perform these tasks. The contractor is responsible for the removal of the clinical chemistry analyzers at the end of the contract period or at the government's discretion. APPENDIX C - TEST MENU REQUIREMENTS Albumin Alk Phos ALT Amylase AST Bilirubin BuBc Bilirubin, Total BUN Calcium Carbon Dioxide (ECO2) Chloride Cholesterol Creatinine dHDL dLDL GGT Glucose % Hemoglobin A1ceins Magnesium Microalbumin Phosphorus Potassium Sodium Total Protein Triglycerides Uric Acid ANTICIPATED NAICS/SIZE STANDARD: This requirement falls under the NAICS Code of 334516, Analytical Laboratory Instrument Manufacturing, with a size standard of 1,000 EMP. SUBMISSION OF INFORMATION: All firms responding to this sources sought notice are advised that their response to this notice is not a request that will be considered for contract award. All interested parties will be required to respond to the resultant solicitation separately from their response to this sources sought notice. A responsible potential sources shall have registered with the System for Award Management (SAM). The response should be no more than five pages providing the following information: Or Equal Product Data Sheet, if any Business name, address, CAGE code Size and socioeconomic classification based on NAICS size standard If claiming a specific small business category, provide supporting documentation Point of contact including email and phone number Please respond to this request by 20 April 2020 at 2:00 PM Pacific Time.