Description
STATEMENT OF WORK (SOW) Scope The STVHCS has a need for a continuous supply of Flow Cytometry reagents and supplies for the government-owned BD FACS Canto II instrumentation housed in the Flow Cytometry Laboratory of the Pathology & Laboratory Medicine Service at Audie L. Murphy VA Hospital. The vendor must provide Becton, Dickinson & Co. (BD) reagents, consumables and supplies and shall be of the highest quality, sensitivity, specificity and tested to assure precision and accuracy as determined by FDA approval for use on the BD FACS Canto II instrument for patient testing. Technical Requirements: The vendor must be able to provide ready to use brand name reagents that are compatible with the BD FACS Canto II instrumentation. The vendor must be able to provide delivery of the following name brand reagents as needed: Item # Description/Part Number* Qty 334224 FACS Shutdown Solution  30 560087 Hu CD123 APC 7G3 100 Tst  3 560503 Hu CD25 PerCP-Cy5.5 M-A251 50 Tst  10 563644 Hu CD49d PerCP-Cy5.5 9F10 50 Tst  8 560448 Hu CD27 Horizon V450 M-T271 120 Tst  10 551108 Hu CD81 FITC JS-81 100 Tst  10 551112 Hu CD81 APC JS-81 100 Tst  10 552843 Ms Ig Kpa Comp Bead Set 6mL  10 555899 Lysing Buffer 10X Concentrate 100 mL  15 555816 Via-Probe Cell Visability Solution 100 Tst  6 554656 Stain Buffer FBS 500mL  40 564114 Hu CD200 BV421 MRC OX-104 50 Tst  10 349516 Anti-Kappa FITC/Anti-Lambda PE  12 341102 CD10 PE-Cy7 HI10a ASR  12 340997 CD103 PE Ber-ACT8 ASR  15 340867 CD117 PE 104D2 ASR  6 340686 CD13 PE L138 ASR  15 341097 CD138 PerCP-Cy5.5 MI15 ASR  12 340682 CD14 FITC MphiP9 ASR  10 642922 CD15 V450 MMA ASR  15 340705 CD16 PE B73.1 ASR  10 643078 CD19 APC-H7 SJ25C1 ASR  12 341023 CD2 APC L303.1 ASR  15 641405 CD20 APC-H7 L27 ASR  12 642283 CD20 V450 L27 ASR  12 340707 CD22 FITC S-HCL-1 ASR  9 340934 CD23 APC EBVCS-5 ASR  8 340948 CD3 PerCP-Cy5.5 SK7 ASR  13 340680 CD33 APC P67.6 ASR  12 340677 CD38 APC HB7 ASR  10 348799 CD4 PE-Cy7 SK3 ASR  14 647450 CD45 V500-C ASR  17 341099 CD5 PerCP-Cy5.5 L17F12 ASR  10 340724 CD56 PE NCAM16.2 ASR  10 335809 CD56 PE-Cy7 NCAM16.2 ASR  8 340706 CD57 FITC HNK-1 ASR  8 642921 CD7 V450 M-T701 ASR  10 341633 CD79a PerCP-Cy5.5 HM47 ASR  2 641409 CD8 APC-H7 SK1 ASR  9 340946 Glycophorin A PE GAR-2 (HIR2) ASR  2 641402 Anti-HLA-DR APC-H7 L243 (G46-6) ASR  8 341632 Myeloperoxidase PE 5B8 ASR  3 340887 Anti-TCR-Gamma/Delta-1 PE 11F2 ASR  2 340883 Anti-TCR-Alpha/Beta-1 FITC WT31 ASR  2 652359 CD11c PE-Cy7 (B-ly6) ASR  8 340345 BD FACS Clean Solution 5L  20 342003 BD FACSFlow Sheath Fluid 20L  20 335775 BD FACS 7-Color Setup Beads 25 Tests  15 642412 BD CST Beads Kit 150 Tests  5 655051 BD FACSDiva CS&T Research Beads Kit 150T  12 349202 BD FACS Lysing Solution 10X 100mL IVD  10 340499 Multitest CD3/CD8/CD45/CD4 50 Tests IVD  35 662967 Multitest 6-color TBNK Reagent US-IVD  35 340041 Simultest IgG1/IgG2a Isotype Control IVD  4 347213 CD34 PerCP-Cy5.5 8G12 ASR  7 341071 CD45 FITC/CD34 PE 2D1/8G12 50 Tests  3 340930 CD41a PerCP-Cy5.5 HIP8 ASR  3 340715 CD61 FITC RUU-PL7F12 ASR  4 The vendor must be able to sequester reagent lots so that the lot numbers will be the same throughout the contract year. The reagents must be FDA approved and meet all regulatory guidelines set for by the STVHCS. The vendor must provide confirmation of order same day as order request is received. The vendor must provide tracking information and provide an estimated delivery time. The contractor shall provide a continuously stocked inventory of Flow Cytometry reagents and supplies, and any other materials required to properly perform patient testing such that Flow Cytometry Laboratory operations are not interrupted. These items shall be of the highest quality, to ensure precision and accuracy. Expiration date must be clearly marked on all supplies. Alert/Notification of any delays in shipment as well as any or all technical advisory/recalls/alerts, prior to or simultaneously with field alerts should be forwarded to the designated individuals determined at contract award. Special handling for emergency orders of supplies: If the supplies are found to be defective and unsuitable for use with the Flow Cytometry Laboratory equipment, or the Contractor has failed to comply with the requirements for routine supply delivery, the Contractor shall deliver the supplies within 24 hours of receipt of a verbal order for emergency delivery. If either circumstance has occurred, the Contractor shall deliver to the Government site in the most expeditious manner possible without additional cost to the Government, the necessary consumables in sufficient quantity as required to allow operation of the Contractor s Core Laboratory equipment for one week (under normal Government test load volume). If additional requests for emergency supply delivery are required by the Government, they shall be honored by the Contractor until the arrival at the laboratory of the monthly standing order/routine supplies delivery. Location The reagents and supplies will be used on the BD FACS Canto II in the Flow Cytometry laboratory located in the Pathology and Laboratory Medicine Service s San Antonio Laboratory of the STVHCS. Period of Performance Base + 4 Option Years Deliverables/Supplies As needed name brand BD reagents and supplies for Flow Cytometry testing on the BD FACS Canto II instrumentation. See Attachment A for a full list of reagent and supplies. Government Inherent Functions: Contractor shall not perform inherently governmental functions. This includes, but is not limited to, determination of agency policy, determination of Federal program priorities for budget requests, direction and control of government employees, selection or non-selection of individuals for Federal Government employment including the interviewing of individuals for employment, approval of position descriptions and performance standards for Federal employees, approving any contractual documents, approval of Federal licensing actions and inspections, and/or determination of budget policy, guidance, and strategy. General Duties, Requirements, and Expectations: Contractor shall be an authorized manufacturer of reagents and supplies requested. Services provided under the terms of this contract are required to be in compliance with the American Association of Blood Banks (AABB) and College of American Pathologists (CAP). Information Systems Officer, Information Protection:   The contractor will not have access to VA Desktop computers nor will they have access to online resources belonging to the government while conducting services. If removal of equipment from the VA is required, any memory storage devices, such as hard drives, solid state drives and non-volatile memory units will remain in VA control and will not be removed from VA custody. Privacy Officer: The contractor will not have access to protected Patient Health Information (PHI) nor will they have the capability of accessing patient information during the services provided to the VA and if removal of equipment from the VA is required, any memory storage devices, such as hard drives, solid state drives and non-volatile memory units will remain in VA control and will not be removed from VA custody. All research data available for Contractor analyses is de-identified. Records Manager: There will be no federal records created, maintained, used or dispositioned with this contract; regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.].