The Minneapolis VAMC requires a five-year cost per test or reagent rental agreement supporting immunofluorescence (IFA) and enzyme immunoassay (EIA) testing as described in the draft Statement of Work below. This is a sources sought looking for businesses for market research purposes. No awards of a contract will be made from this announcement. Identify your organization's socio-economic category. Identify if your organization is the manufacturer of the required supplies. If you are not the manufacturer, identify the manufacturer of the supplies that you will provide. Identify whether any foreign end products, as defined in FAR Provision 52.225-2, would be provided to meet this requirement ( https://www.acquisition.gov/far/part-52#FAR_52_225_2__d3401e52).  Address whether your organization meets the requirements of 13 CFR 121.406 (b)(1)(i), (b)(1)(ii) and (b)(1)(iii) (https://www.ecfr.gov/current/title-13/chapter-I/part-121/subpart-A/subject-group-ECFR0fca5207262de47/section-121.406#p-121.406(b)).  If you are a vendor that can provide the requested information and the required supplies described below with competitive pricing, send your organization s information with a description of proof of capability to:
[email protected] on or before 17:00 CDT, May 26th, 2023. *If applicable, 852.219-76 VA Notice of Limitations on Subcontracting Certificate of Compliance for Supplies and Products, will apply to any potential solicitation if set-aside for Veteran Owned Small-Businesses.* *If applicable, FAR Provision 52.219-14 Limitations on Subcontracting, will apply to any potential solicitation if set-aside for Small-Businesses.*  *If applicable, 852.212-71 Gray Market Items, will apply to any potential solicitation.* Statement of Work Specialty Immunoassay testing by IFA and EIA BASIC REQUIREMENT: The Minneapolis VAMC Immunology Laboratory has a need for a five-year cost per test or reagent rental agreement supporting immunofluorescence (IFA) and enzyme immunoassay (EIA) testing. The cost per test or reagent rental is to include reagents, controls, calibrators, consumables, one Bio-Rad PhD lx System (Brand name or equal), installation, validation, interfacing, training, technical support, preventative maintenance, service (including parts, labor, and travel), UPS, computer, printer, monitor and all shipping costs during the term of the agreement. Listed below are the estimated annual quantities of tests to be run for this base plus four contract. Schedule of Tests Test Menu Estimated annual quantities Fluorescent anti-nuclear antibody (FANA) 5000 MSK (Mouse-Stomach-Kidney) Anti-smooth muscle antibody (ASMA) Anti-mitochondrial antibody (AMA) Anti-Parietal cell antibody (APCA) 1200 Anti-DNA antibody                                                             900 Anti-neutrophil cytoplasmic antibody (ANCA) (3rd party assay) 700 The Immunoassay testing system that meets the Minneapolis VAMC s requirement is the Bio-Rad PhD lx System or an equivalent with possessing the salient/operational characteristics listed below. Offerors are requested to list the brand name, manufacturer, and catalog number of each line item offered. If offeror is offering other than brand name, evidence must be submitted, including descriptive literature, that supports that the product bid is an equal product. Acceptability of equal products will be determined solely by the Minneapolis VAMC. SALIENT CHARACTERISTICS/OPERATIONAL FEATURES: Analyzer must be able to perform both EIA and IFA testing on same analyzer Dimensions not to exceed 36 (W) x 27 (D) x 30 (H) Analyzer must be an open system, one in which reagents from third party vendors are able to be used. Sample capacity for EIA of 192 and IFA of 96 Capacity of 2 microplates and 20 slides Must have 2 modes for IFA Slide Washing: cycle wash and hyper-wash with simultaneous dispense/aspiration. Sample volume delivery of 1-100µL Microplate reader filter wavelengths need to be 405, 450, 550, and 620 nm. In-well dilutions down to 1µL of sample Magnetic rack positioning Automated air bubble removal Dual-probe hyper-washing There must be a cap valet to prevent contamination The ANA titer used must be a minimum of 1:80 Must have a well by well wash/reagent dispense for washing wells individually. Flooding the slide and performing multi slide soak/wash is unacceptable Must not use disposable tips Instrument is to have only 1 moving part to keep it easy to use and maintain Minimal maintenance required. Anything more than weekly maintenance is unacceptable. Hep2-substrate: 12 well slides Mouse Stomach Kidney (MSK) substrate: 8 well slides Crithidia luciliae (DNA) substrate: 8 well slides Reagents must be FDA 510(k) cleared SOFTWARE: Bi-directional host and host query capabilities utilizing Data Innovations. Must be capable of data storage. The system must be capable of retransmitting the results to the Laboratory Information System (LIS). Vendor will ensure that all components are utilizing the latest software revision. The instrument s computer operating system must be Windows 10 or higher. INSTALLATION, VALIDATION AND TRAINING: Contractor shall provide installation and validation of the analyzer, including labor and travel. Contractor shall provide training on the analyzer. This shall include training on the operation of the system, maintenance, data manipulation, basic troubleshooting, and repair. If off-site training is provided, all costs for trainee shall be provided by contractor. Contractor shall assist with the performance of all validation studies: precision, method comparison with current instrumentation, accuracy (recovery), linearity (reportable range), calibration verification, and determination of sensitivity and specificity. The contractor shall perform all statistical analysis and report data in an organized, clearly comprehensible format. The contractor shall have provided all equipment, reagents, calibrators, controls, consumables, parts, and accessories required to establish operation and perform all validation studies and method comparisons. COST PER TEST / REAGENT RENTAL: One new analyzer shall be provided under this contract agreement, Bio-Rad PhD lx System. All new equipment shall be shipped within 30 days of receipt of award. The cost per test or reagent rental is to include reagents, controls, calibrators, consumables, one Bio-Rad PhD lx System, installation, validation, interfacing, training, technical support, preventative maintenance, service (including parts, labor, and travel), UPS, computer, printer, monitor and all shipping costs during the term of the agreement. Any component not included in the agreement as defined in the statement of work must be individually specified for inclusion on the contract line-item schedule. Contractor shall retain ownership of the analyzer. Standard manufacturer warranty must be included. Upon termination of the contract, the Minneapolis VAMC Biomedical department will remove the hard drive and terminate it according to policies and procedures. The analyzer will be the contractor s responsibility to dismantle, decontaminate, and remove from Minneapolis VAMC premises within 60 days after expiration of contract. All costs for removal and return to contractor shall be borne by the contractor. Due to space constraints, analyzers will require moving, once. They will be in a temporary location for validation and need to be moved to a permanent location when they are put into production. Vendor will be responsible for moving analyzers for this one time move, at no cost to the Government. ANALYZER MAINTENANCE: Contractor agrees to maintain the analyzer in good working condition and will repair or replace any defects during the contract period (including parts, labor, and travel). Maintenance/Service Calls: Technical support, analyzer maintenance and repair service must be available. A technical assistance center must be available Mon-Fri, 8am-4:30pm. On-site service must be provided within 48 hours of determination that site service is required, and be completed during Mon-Fri, 8am-4:30pm. Contractor shall provide standard warranty response and analyzer service, including parts, labor, and travel. Preventive Maintenance: Contractor will provide scheduled preventive maintenance (PM) service calls as required by manufacturer s recommended PM schedule, procedures, and checklists. Contractor will work with Minneapolis VAMC to schedule at a time that works for both parties. A field service report shall be supplied to the Minneapolis VAMC at the completion of each PM inspection. Equipment provided by the contractor shall maintain an uptime of 95% during each month of the agreement. If the repair record of equipment provided by the contractor reflects a downtime of 5% or greater during each month of the agreement, the Minneapolis VAMC may request a replacement of malfunctioning equipment with new equipment at no charge to the Minneapolis VAMC. Upgrades: The vendor must provide upgrades to instrument hardware and software to maintain the integrity of the system and state-of-the art technology at no additional charge to the Government. This must be provided as they become commercially available and at the time as they are being provided to commercial customers. This requirement only applies to system upgrades that enhance the model of equipment being offered (. i.e., new version of software, correction of hardware defect, upgrade offered to commercial customers at no additional charge, upgrade to replace model of equipment no longer vendor supported, etc. Minneapolis VAMC uses Data Innovations as the universal interface. The vendor is responsible for providing all components required for the installation, implementation, and operation of the interface right up to the universal interface box. If there are any software upgrades in the analyzers during its life, the vendor is responsible for verifying that the interface can accommodate any changes in the data stream going to the MINNEAPOLIS VAMC computerized patient record system. In addition, the vendor shall include all ancillary components that are customarily sold or provided with the model of analyzer proposed (ex: computer monitors, printers, UPS, starter kits, etc). The vendor shall provide a procedure manual formatted in accordance with current Clinical & Laboratory Standards Institute (CLSI) guidelines, and update as they occur. ORDERING PROCEDURES: All new equipment shall be shipped within 30 days of receipt of award. Consumables shall arrive within five calendar days after receipt of an order. The vendor will schedule with the Minneapolis VAMC for installation of equipment and training of key equipment operators, which shall be scheduled as soon as possible after receipt of equipment at Minneapolis VAMC. Consumable orders will be placed by authorized Minneapolis VAMC laboratory personnel on an on-demand, as needed basis. The contractor shall provide the following information to expedite orders: Preferred method of ordering: Telephone number: Fax number: Email address: Point of contact name, email address, and phone number: DELIVERIES: All consumables shall be delivered FOB Destination to MINNEAPOLIS VAMC and shall arrive within 5 calendar days after receipt of an order. All deliveries shall be accompanied by a delivery ticket or packing slip which shall contain: the vendors name, purchase order number, date of order, date of delivery, and an itemized list of products furnished including product description, stock number, and quantity shipped. Failure to produce this will cause there to be nonpayment for shipped items. Deliveries shall be made to: VA Medical Center, Bldg 70 Warehouse (90D), PO#________ One Veterans Drive Minneapolis, MN 55417 Delivery times: Between 8:00 am and 3:30pm Monday-Friday, except Federal Holidays PRODUCT QUALITY AND QUALITY CONTROL: All products offered to the MINNEAPOLIS VAMC must be of the same consistent high quality as would be offered to the general commercial public in the United States. All defective or inferior products must be replaced within 48 hours at no cost to the Minneapolis VAMC. The Contractor will immediately notify the MINNEAPOLIS VAMC of any recalls of product or other important safety issues. As appropriate, the Contractor will replace and/or reimburse recalled/defective products at no cost to the government. The Contractor may be liable for costs of processing recalls, i.e., administrative, and clinical services to replace recalled/defective products. ROTATION OF STOCK: To assure rotation of stock at the distributor, each lot of a product received must have an out date the same or later than the lot previously received. Only one lot of any item may be shipped per delivery, unless part is the old lot previously received and part is the new lot which will be shipped the next delivery. HAZARDOUS MATERIALS: Upon award, the contractor shall provide MINNEAPOLIS VAMC with a listing of the vendor s products used with the analyzers that are considered hazardous. The listing should also include a determination as to what can be considered harmless to be disposed of by normal methods, such as disposing in the sink or disposing in the trash, and what must be specially handled for disposal and how it is handled. The contractor is required to provide a list identifying any "hazardous materials" that may be provided as a part of this contract that are defined as hazardous under the latest version of Federal Standard No. 313. SDS shall be available when requested by the Minneapolis VAMC.