6550--SOLE SOURCE NOTICE - Hologic Panther Supplies

Presolicitation Notice Presolicitation Notice Page 4 of 4 Presolicitation Notice Presolicitation Notice Page 1 of 4 This notice is in accordance with (IAW) Federal Acquisition Regulation (FAR) subpart 5.2. The Department of Veterans Affairs (VA), Network Contracting Office (NCO) 09, hereby provides notice of its intent to award a sole source, firm-fixed price indefinite delivery contract for the product/service listed below to a large business, Hologic Inc., headquartered out of California. The contract is expected to be awarded under the authority of FAR subpart 13.5. A Sole Source Justification for Other Than Full and Open Competition has been prepared. The anticipated award date is no later than 3/1/2024.The contractor will provide the product/service listed below to the place of performance listed on the cover page of this notice. This action is for recurrent Hologic Panther system reagents, controls, and consumables for James H. Quillen VA Medical Center s (JHQVAMC), Microbiology lab. The Panther Fusion analyzer was purchased and installed on 10/14/2021. The Executive Leadership Team (ELT) directed the laboratory to utilize this test platform to do COVID testing for employees, screen CLC staff, and Dom Staff. The Panther is a random access analyzer and will help Mountain Home manage surveillance COVID testing during outbreaks. JHQVAMC also intends to bring in-house testing for Quantitative HCV, and Chlamydia/Gonorrhoeae on the Hologic Panther System. Utilizing this testing platform for these purposes/intentions saves the government taxpayer money, improves testing turn-around time and physician diagnosis, and reduces Veteran patient inconvenience by lessening return visits for lab results and additional physician consultations, if required. Listed below are the estimated volumes of reagents and consumables that are needed to support this requirement for one year. Market research found no other vendors providing like product/service as the Panther system and its reagents, controls, and consumables are proprietary. Also, the Hologic Aptima COVID test kits are mandated by the Food & Drug Administration (FDA) to be used only on Hologic Panther system. Using other than Hologic COVID reagents, controls, consumables on the Hologic Panther system not only could damage the equipment but could lead to erroneous test results/analysis. Product/Service Required: Estimated 1 year of COVID reagents and Consumables for the Panther System Item # Description/Part Number* Qty Price Extended Amount 1 PRD-06419 Aptima SARS-CoV-2 Assay,250-Test 60 2 PRD-06420 Aptima SARS-CoV-2 Assay Controls 65 3 PRD-06997 Hologic Direct Load Tube, 100/bag 135 4 PRD-03705 Aptima HV Quant Dx Assay Kit, 100-Test 10 5 PRD-03706 Aptima HCV Quant DX Control Kit As needed 6 PRD-03707 Aptima HCV Quant DX Calibrator Kit As needed 7 303096 Panther System Run Kit (Includes Product No. 303014, 303013,104772-02,902731 and 504405) As needed 8 104772-02 MTUs (multi-tube units) (100 Tubes/case) As needed 9 303013 Aptima Auto Detect (1000 tests) As needed 10 303014 Aptima Assay Fluids (1000 tests) As needed 11 504405 Waste Bin Covers (10/Ea) As needed 12 902731 Waste Bin Bags (10/Ea) As needed 13 CL0040 Spare Caps, TRC+Select 250 Kit As needed 14 CL0041 Spare Caps, AMP&Probe 100&250 kit Enzyme 100 Kit As needed 15 303085 Panther Advance Cleaning Solution As needed 16 501616 Spare Caps, Enzyme 250 Kit As needed 17 501604 Spare Caps, TCR, Aptima 2x50 kits As needed 19 504415 Transport Tube Cap, 100/pack As needed 20 PRD-03455 Panther Run Kit for Real Time Assays As needed 21 PRD-03503 Aptima Specimen Diluent US 2 22 PRD-03654 Aptima Specimen Diluent Kit US 2 23 PRD-05576 Aptima Combo 2-100 test Kit 8 24 PRD-05571 Aptima Combo 2-250 test Kit As needed 25 301040 Kit Aptima Combo 2 urine specimen collection As needed 26 301041 Kit Aptima Combo 2 swab specimen collection As needed 27 PRD-03546 Aptima Multitest Swab Collection As Needed 28 301154C Kit Aptima LPT-IVD sale bom As needed 29 105575 Aptima Urine Collection Tubes As needed 30 MTL-02093 500 Pack Pipet Trans Dispo 5ML As needed 31 301110 Aptima CT/GT Control Kit (1 tray) IVD As needed 32 PRD-03706 HCV Quant Assay Controls, Aptima, US IVD As needed 33 PRD-03707 HCV Quant Assay Calibrator, Aptima, US IVD As needed 34 FAB-18184 Specimen Aliquot Tube Pack As needed 35 PRD-06952 Direct Load Capture CAP Collection Kit-FLOQ Swab As needed 36 4339 Panther Fusion Specimen Lysis TUBE 150 37 15668 Kit, Penetrable Caps 2 This estimate is not a representation to anofferoror contractor that the estimated quantity will be required or ordered, or that conditions affecting requirements will be stable or normal. All products are made in the USA Estimated Value: $2,000.000.00 for a 3-year Ordering Period Indefinite Delivery Contract. Period of Performance: As-Needed covering a 3-year period of performance with an anticipated end date of 9/30/2026. NAICS code: 325413 In-Vitro Diagnostic Substance Manufacturing SBA Small Business Size Standard: 1250 employees PSC: 6550 THIS NOTICE OF INTENT IS NOT A SOLICITATION OR REQUEST FOR COMPETITIVE QUOTES. However, interested parties may identify their interest and capability to respond to this requirement and may submit a bid, proposal, or quotation (as appropriate) that the agency shall consider within the given closing/due date of this notice. A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government. Information received will normally be considered solely for determining whether to conduct a competitive procurement. The Department of Veterans Affairs will NOT be responsible for any costs incurred by interested parties in responding to this notice of intent. Only written responses will be considered. All responses from responsible sources will be fully considered. As a result of analyzing responses to this notice of intent, the Government shall determine if a solicitation will be issued. Any prospective contractor must be registered in the System for Award Management (SAM) to be eligible for award and must submit a current authorized distributor letter from the manufacturer. Interested parties are encouraged to furnish information by email only with RESPONSE TO NOTICE 36C24924Q0093 in the subject line. All documents submitted will not be returned. All interested parties shall submit clear and convincing documentation demonstrating their capabilities to satisfy the requirements listed above to the point of contact (POC) listed on the cover page of this notice and NO LATER THAN the given closing date and time on this notice. The capability documentation should include general information and technical background describing in detail the prospective contractor's capabilities like an authorized distributor/reseller letter from their source of supply if not a manufacturer that will demonstrate the ability to support this requirement.