Special Notice Special Notice Page 3 of 3 Special Notice *= Required Field Special Notice Page 1 of 3 Special Notice Notice of Intent to Award a Sole Source Procurement The Department of Veterans Affairs, Veterans Health Administration, Network Contracting Office 17, intends to award a Firm-Fixed priced, IDIQ contract with three ordering periods to BD Biosciences. This order is for an IDIQ contract for BD FACSLyric flow cytometry system and the BD FACS Sample Prep Assistant and testing supplies. CD33 PE-Cy7 P67.6 ASR EA 63 CD2 PE-Cy7 L303.1 ASR EA 63 Multitest CD3/CD8/CD45/CD4 50 Tests IVD EA 14 CD34 FITC 8G12 ASR EA 71 Anti-HLA-DR APC L243 (G46-6) ASR EA 71 CD16 PE B73.1 ASR EA 63 Anti-TCR-Alpha/Beta-1 FITC WT31 ASR EA 63 Anti-TCR-Gamma/Delta-1 FITC 11F2 ASR EA 63 CD22 APC S-HCL-1 ASR EA 63 CD23 APC EBVCS-5 ASR EA 71 CD103 FITC Ber-ACT8 ASR EA 71 CD25 PE 2A3 ASR EA 71 CD5 PerCP-Cy5.5 L17F12 ASR EA 63 CD19 PE-Cy7 SJ25C1 ASR EA 63 Myeloperoxidase PE 5B8 ASR EA 63 CD79a PerCP-Cy5.5 HM47 ASR EA 63 CD30 (BerH8) PE ASR EA 63 BD FACSFlow Sheath Fluid 20L EA 3 Anti-TdT APC E17-1519 ASR EA 63 CD34 PerCP-Cy5.5 8G12 ASR EA 63 CD5 Biotin L17F12 100 Tests RUO/GMP EA 63 CD34 PE-Cy7 8G12 ASR EA 63 BD FACS Lysing Solution 10X 100ML IVD EA 60 Ms Ig Kpa Comp Bead Set 6mL EA 89 Stain Buffer BSA 500mL EA 89 Lysing Buffer 10X Concentrate 100mL EA 89 7-AAD Staining Solution 2mL EA 92 Hu CD56 (NCAM-1) Hrzn V450 B159 120Tst EA 89 Hu CD57 APC NK-1 50Tst EA 89 Hu CD38 BV605 HB7 100Tst EA 90 Hu CD19 BV711 SJ25C1 100Tst EA 90 Hu CD5 BV510 UCHT2 100Tst EA 90 Hu CD7 BV510 M-T701 100Tst EA 90 Brilliant Stain Buffer 100Tst EA 90 Hu CD163 PerCP-Cy5.5 GHI/61 100Tst EA 89 Hu CD11c BV605 B-ly6 100Tst EA 90 Hu CD200 BV421 MRC OX-104 50Tst EA 90 Hu CD8 BV605 SK1 100Tst EA 90 Hu CD10 BV786 HI10A 100Tst EA 90 Hu CD5 APC-R700 UCHT2 100Tst EA 90 Hu CD3 BV786 UCHT1 50Tst EA 90 Hu TCR Cbeta1 PE JOVI.1 50Tst EA 89 Anti-HLA-DR APC-H7 L243 (G46-6) ASR EA 63 CD20 APC-H7 L27 ASR EA 63 CD45 APC-H7 2D1 ASR EA 63 BD IntraSure Kit RUO EA 99 BD Horizon CD15 (MMA) V450 ASR EA 71 Anti-Lambda PE 1-155-2 ASR EA 63 Anti-Kappa FITC TB28-2 ASR EA 71 CD64 PE 10.1 ASR EA 71 BD Horizon CD45 (2D1) V500-C ASR EA 71 CD26 PE (L272) ASR EA 63 BD Horizon CD14 (M P9) V450 ASR EA 63 CD71 APC-H7 M-A712 ASR EA 63 CD16 FITC CLB-Fc-gran/1 5D2 ASR EA 63 CD36 FITC CLB-IVC7 ASR EA 63 CD49d APC-H7 (9F10) ASR EA 63 BD Horizon CD13 (L138) APC-R700 ASR EA 63 BD Horizon CD56 (NCAM16.2) APC-R700 ASR EA 63 CD123 APC (9F5) ASR EA 63 BD Horizon CD3 (SK7) APC-R700 ASR EA 63 FC Bead Dilution Buffer EA 66 BD FC Beads APC-H7 EA 62 BD FC Beads V450 EA 62 BD FC Beads V500-C EA 62 BD FC Beads APC-R700 EA 62 BD FC Beads BV605 EA 62 BD FC Beads BV421 EA 62 BD FC Beads BV510 EA 62 BD FC Beads BV711 EA 62 BD FC Beads BV786 EA 62 CST beads 50T IVD EA 62 CST beads 150T IVD EA 62 BD Horizon CD11b (D12) BV605 ASR EA 74 BD Horizon CD7 (M-T701) BV605 ASR EA 74 BD Horizon CD117 (104D2) BV605 ASR EA 74 Scope: The Contractor will provide one (1) new Sample Preparation System and all ancillary components including all system software, UPSs, monitors, auto-handlers, scanners, printers, instrument stands, technical support, off-site customer training, and business hours service plan. This system must be compatible with the current Flow Cytometers and software currently in use in the laboratory. The current test volume is estimated at 2,000 tests for the quantitative lymphocyte subset and 800 tests for Leukemia/lymphoma Immunophenotyping. Contractor shall: Deliver, install, and set up the instrument and components. Provide test validation guidance and validation supplies. Provide technical support and guidance. Provide reagents, consumables, and supplies as requested by VANTHCS staff to perform testing utilizing both the sample preparation system and flow cytometers. Provide setup for interfaced result reporting, which includes LIS physical connection and translation (drivers), and any required (additional) interface connection license(s). Provide instrument repairs and scheduled preventive maintenance for the instrument and system components. Provide basic and advanced operator training. Location: The analyzer shall be located, and testing will be performed in the Flow Cytometry section of Client Services & Immunopathology, Room 1B-424, Pathology & Laboratory Medicine Service, VA North Texas Health Care System, 4500 S. Lancaster Rd., Dallas, TX 75216. Performance Requirements: The following are required: System Requirements: Sample Preparation System System designed to work with the BD FACSLyric Flow Cytometer that exists in the lab currently. System designed to work with the BD FACSuite Application that exists in the lab currently. Automated cocktailing of reagents. Ability to accommodate multiple reagent vials, not vendor specific. Complete list of potential antibody reagents used on the system. (Attachment A) Traceability of specimens, reagent vials, and reagent cocktails. Primary specimen tube loading capability with throughput at <190 minutes. Bidirectional LIS compatibility with Data Innovations and VistA. Capable of onboard washing of sample tubes. Capable of onboard centrifugation of sample tubes. Includes instrument workbench (stand) to accommodate the sample preparation instrument and flow cytometer. Maintenance: The Contractor shall perform preventive maintenance at intervals specified by the manufacturer to ensure proper equipment performance. Preventive Maintenance includes the following: The Sample Preparation System for the entirety of the contract. The two existing BD FACSLyric Flow Cytometers and universal loaders for the entirety of the contract. The existing FACS Sample Prep Assistant for the base year to support validation of the new Sample Preparation System. Delivery of parts or materials for Preventive Maintenance. Testing all components for proper test performance. Equipment shall reproduce results according to the manufacturer s specifications. After Preventative Maintenance, the Contractor shall submit a detailed work report for notice at no additional cost. The Contractor shall provide all preventive service materials at no additional cost to the government. Technical Support: Support Personnel will be available during business hours each business day, and live representatives via the Contractor s message center will be available by telephone at all other times. Technical support shall be available via telephone during business days (and by message center after hours) to provide troubleshooting assistance or to answer testing inquiries. On-site technical support shall be available for escalations within 48 hours. On-site Repairs and Service Support: Service support includes the following: The Sample Preparation System for the entirety of the contract. The two existing BD FACSLyric Flow Cytometers and universal loaders for the entirety of the contract. The existing FACS Sample Prep Assistant for the base year to support validation of new Sample Preparation System. For issues that the Contractor determines to require on-site support, the Contractor shall dispatch one or more Support Personnel, normally within 48 business hours after documentation. The Contractor shall submit a detailed work report to include all required materials. The Contractor shall provide all parts and materials (including ancillary components (workstation computer, workstation printer) at no additional cost the government. The Contractor shall remove all parts, equipment or materials replaced, or upgraded by the Contractor due to and not limited to repairs, replacements, recall, and upgrades without any cost to the government. Training: The contractor shall provide the following: Two initial off-site operator training of analyzer Two additional off-site Basic Operator training for BD FACSLyric with BD FACSuite Clinical Software. Handouts and training materials in sufficient quantity for each participant. These are off-the-shelf courses. The contractor shall provide lesson plan, course materials and media (DVD s, CD s, videos, etc. if required), and editable procedures at no additional cost. Additional on-site training as requested by VANTHCS at no additional charge. Safety: The Contractor shall immediately notify VANTHCS of any changes in reagent kit composition, procedure modification, recall notification, or any changes that will affect the performance of the test or procedure according to FDA regulations. Test Performance: All procedures and equipment must be performed at the manufacturer s specifications. Deviations from the performance specifications shall be corrected by the Contractor. Test performance will be evaluated by and not limited to performance through peer comparison, quality control, and CAP peer evaluation. The vendor shall reimburse VANTHCS for any costs and/or supplies related to tests sent to a referral laboratory when testing is not available through no fault of the facility due to reagent problems, other product issues, instrumentation failure, or other factors. The assessed damages shall be applied to the invoice in the form of a credit or deduction. Period of Performance: The agreement will be in IDIQ contract for with thres (3) ordering periods: Ordering Period 1 May 17, 2025, through May 18, 2026 Ordering Period 2 May 17, 2026, through May 18, 2027 Ordering Period 3 May 17, 2027, through May 18, 2028 The vendor shall remove all equipment within 90 days after notification of the expiration of the terms of this agreement but not until the completion of the vendor's equipment installation inclusive of completed cross-over studies. The Vendor shall be responsible for removing the hard drive and turning it over to the VANTHCS for destruction before removal of any analyzer. Deliverables and Supplies: This order is for the cost per test procurement of an instrument/system for testing by flow cytometry. Reagents and supplies will be purchased under the terms of the reagent rental purchase agreement. The Contractor shall deliver all supplies necessary for test performance at no Government cost. The Contractor shall deliver all and not limited to operational, maintenance, troubleshooting, small repairs, equipment specifications, and test manuals. The Contractor shall install the equipment and perform test verification according to manufacturer specifications and CAP requirements. The Contractor shall provide supplies: reagents and consumables for WBC Immunophenotyping and CD4/CD8 testing. Additional testing may be added at the discretion of VANTHCS. Any additional testing shall be negotiated between the Contractor and VANTHCS. If requested supplies are on back-order, then the Contractor is to provide information as to the estimated time of availability. The Contractor shall deliver all invoices for review according to the established contract at the end of each billing cycle. All items not contracted shall be specifically detailed on the invoice including description, quantity acquired, and government cost. Any changes in reagents or equipment modifications shall be immediately disclosed by the Contractor electronically as well as by postal mail with supporting documentation of the change, and detailed guidance for implementation within twenty-four hours of its application. Additional charges incurred by the government to provide the continuity of contracted tests to patients and not limited to outsourcing, transportation, and or any other additional cost shall be covered by the Contractor at no additional charge to the government. Contractor Security Contract Requirements: This Contractor requires no access to VANTHCS or any VA information system. The analyzer will be interfaced to the VANTHCS information system through Data Innovations. There will be supervised access when the Contractor is physically present for technical support, service calls, and scheduled preventative maintenance. This notice is not to be considered a request for quotations or proposals. A contract will not be awarded based on an offer received in response to this notice; however, all responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency. Proposals or offers received will be used to determine if a comparable source is available and more advantageous to the government. If no affirmative written response is received within 3 days from the publication of this notice, a contract/order will be issued to Cepheid without any further notice. The proposed contract actions are for services, which the government intends to negotiate with only one source. The anticipated statutory authorities permitting other than full and open competition for the requirement is 41 U.S.C. 3304(a)(1), as implemented by FAR 6.302-1, Only one responsible source and no other supplies or services will satisfy agency requirements. The proposed sole source procurement will be made by a pricing agreement with BD Bioscience.