6550--Blood Bank Tube Reagents

Department of Veterans Affairs Pathology & Laboratory Medicine Service (P&LMS) VISN 16 G.V(Sonny) Montgomery VAMC 1500 E Woodrow Wilson Av Jackson MS 39216 Alba Brand Tube Blood Bank Reagents 1. PURPOSE The purpose is to provide Alba Brand Tube method Blood Bank reagents for the support of Transfusion Medicine Testing. The Blood Bank department performs a range of tests which include type and screen, antibody identification, and crossmatches. Physicians rely on the accuracy and timeliness of these tests in order to administer potentially lifesaving treatments through blood and other blood products. Jackson, MS VAMC use tube reagents as a back up to their primary testing method or as supplemental testing. 2. SCOPE 2.1. The Contractor shall be able to provide all listed reagents. 2.2. Reagents will be shipped on a standing order schedule. 2.3. All products must meet all salient characteristics defined in this section. 2.4. All reagents must meet manufacturers and VA specifications. 2.5. The Contractor shall perform to the standards in this contract. 2.6. SALIENT CHARACTERISTICS • All the reagents shall be prepackaged and ready for use. • All reagent red blood cells must be in compliance with the Code of Federal regulations-21 CFR Part 660 Subpart D-Reagent Red Blood Cells. • These items shall be of the highest quality, sensitivity and tested to assure precision and accuracy. • Expiration dates must be clearly marked on all reagent containers. • Unexpected changes in methodology/technology shall be at the expense of the contractor. • The contractor shall state the open date stability for the reagents for both room temperature and refrigeration. • The contractor shall package reagents in such a manner as to ensure the integrity of the reagents during transport. • The contractor shall explain their policy on replacement of unsuitable or damaged products or products shipped in error. • The contractor shall supply all package inserts, Safety Data Sheets, and other relevant information for their proposed reagents. • The contractor shall inform each COR of any reagent recalls or bulletins due to product unavailability due to manufacturing issues. • Alert/Notifications of any delays in shipment as well as any or all technical advisory/recall/alerts, prior to or simultaneously with filed alerts should be forwarded to each contracting officer. • The contractor shall provide their plan for product availability if supplies/products become scarce or unavailable. -- 1 of 5 -- • Vendor shall provide a VA acceptable itemized bill for all items shipped for payment with each shipment. • Payments will be made in arrears. 2.7. DELIVERY & SHIPPING 2.7.1. Delivery of reagents will be on an as standing order basis. 2.7.1.1 Locations: 1) G.V (Sonny) Montgomery VAMC 1500 E Woodrow Wilson Ave Jackson, MS Basement, Laboratory C-19 Attn: Blood Bank 2.7.2. Contractor shall deliver all reagents acceptably packaged to each location listed. 2.7.3. Contractor shall ship reagents on a standing basis to each location as follows: G.V (Sonny) Montgomery VAMC Reagent Quantity Frequency Total A1 Cells 2 Every 4 weeks 28 A2 Cells 2 Every 4 weeks 28 B Cells 2 Every 4 weeks 28 Antibody Screening Cells (3 Panel) 2 Every 4 weeks 28 Antibody Identification Cells (10 Panel) 1 Every 4 weeks 13 IgG Sensitized Cells 4 Every 4 weeks 52 C3 Cells 2 Every 4 weeks 28 QC Kit 1 Every 4 weeks 13 3. INSPECTION AND ACCEPTANCE: 3.1. The COR shall ensure all items are satisfactory prior to acceptance. Disputes shall be resolved by the Contracting Officer. 3.2. The designated COR’s for each facility are as follows: G.V (Sonny) Montgomery VAMC Point of contact given after contract award. 4. DELIVERY/STORAGE REQUIREMENTS 4.1. Deliver reagent materials to job in manufacturer's original sealed containers with brand name marked thereon. 4.2. Package to prevent damage or deterioration during shipment, handling, and storage. 4.3. Deliver specified items only when the site is ready to proceed. 4.4. Store products in dry condition inside enclosed facilities. 4.5. Delivery dates will be communicated when products orders are placed. 4.6. Delivery will be coordinated through the Blood Bank Supervisor for the G.V (Sonny) Montgomery VAMC and the Blood Bank Supervisor for VHSO. -- 2 of 5 -- 5. Installation is not required. 6. DELIVERABLES 6.1 Reagent Type A1 Cells Tube A2 Cells Tube B Cells Tube Antibody Screening cells-3 Panel Cell Tube Antibody Identification Cells -10 Panel Cell Tube IgG sensitized Cells Tube QC Kit Tube C3 Coated Cells Tube 7. SECURITY REQUIREMENTS 7.1. GENERAL Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security. 7.2. SECURITY CLAUSE: "A&A requirements do not apply--Security Accreditation Package is not required". 8. NARA Records Management Language Clause: The following standard items relate to records generated in executing the contract and should be included in a typical contract: 8.1 Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion. 8.2 In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the …