INTRODUCTION THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION. The National Heart, Lung, and Blood Institute (NHLBI), Office of Acquisitions (OA), intends to negotiate and award a purchase order on a noncompetitive sole source basis to BD Biosciences, 2350 Qume Drive, San Jose, CA 95131-1812, to provide reagents to the NHLBI Division of Intramural Research (DIR) Flow Cytometry Core. BACKGROUND In cell biology, flow cytometry is a laser-based, biophysical technology employed in cell counting, cell sorting, biomarker detection and protein engineering by suspending cells in a stream of fluid and passing them by an electronic detection apparatus. It allows simultaneous multi-parametric analysis of the physical and chemical characteristics of up to thousands of particles per second. Flow cytometry is routinely used in the diagnosis of health disorders, especially blood cancers, but has many other applications in basic research, clinical practice and clinical trials. A common variation is to physically sort particles based on their properties, so as to purify populations of interest. PURPOSE The purpose of this acquisition is to acquire reagents / antibodies for phenotyping cells. PROCUREMENT The contractor shall provide the following reagents: - Anti-Kappa FITC TB28-2 ASR (Qty. 15); - Anti-Lambda PE 1-55-2 ASR (Qty. 4); - CD10 APC HI10a ASR (Qty. 4); - CD117 APC 104D2 ASR (Qty. 3); - CD117 PerCP-Cy5.5 104D2 (Qty. 15); - CD11b APC D12 100 Tests RUO/GMP (Qty. 2); - CD13 PE L138 ASR (Qty. 2); - CD14 APC-H7 MphiP9 100 (Qty. 2); - CD19 PE SJ25C1 50 Tests RUO/GMP (Qty. 4); - CD19 PE-Cy7 SJ25C1 ASR (Qty. 3); - CD3 PerCP-Cy5.5 SK7 ASR (Qty. 8); - CD33 PerCP-Cy5.5 P67.6 50 (Qty. 15); - CD34 PE-Cy7 8G12 ASR (Qty. 4); - CD5 PE L17F12 100 Tests RUO/GMP (Qty. 3); - CD5 PerCP-Cy5.5 L17F12 50 (Qty. 4); - CD57 FITC (Qty. 4); - CD8 APC-H7 SK1 ASR (Qty. 3); - CD36 FITC CLB-IVC7 ASR (Qty. 3); - CD34 PerCP-Cy5.5 8G12 ASR (Qty. 8); - CD27 APC L128 100 Tests RUO/GMP (Qty. 1); - CD61 FITC RUU-PL7F12 100 (Qty. 4); - BD FACS Lysing Solution 10X 100ML IVD (Qty. 6); - BD Stabilizing Fixative 3X Conc 90mL (Qty. 6); - Hu CD138 PE MI15 100Tst (Qty. 2); - Hu CD123 APC 7G3 100Tst (Qty. 2); - Hu CD16 FITC 3G8 100Tst (Qty. 4); - Hu CD42b FITC HIP1 100Tst (Qty. 4); and, - Hu CD45 Horizon V500 HI30 100Tst (Qty. 12). JUSTIFICATION BD Biosciences is the only contractor that can provide these reagents as they are the only ones that are validated for or fit into the existing workflow and instrumentation. No other contractor carries equivalent substitutes. Changing contractors would invalidate current work practices and jeopardize the lab's accreditation. The Hematology Branch requires these reagents for tests performed under CLIA regulations. CLIA is defined below: Congress passed the Clinical Laboratory Improvement Amendments (CLIA) in 1988 establishing quality standards for all laboratory testing to ensure the accuracy, reliability, and timeliness of patient test results regardless of where the test was performed. The final CLIA regulations were published in the Federal Register on February 28, 1992. The requirements are based on the complexity of the test and not the type of laboratory where the testing is performed. On January 24, 2003, the Centers for Disease Control and Prevention (CDC) and the Centers for Medicare & Medicaid Services (CMS) published final CLIA Quality Systems laboratory regulations that became effective April, 24, 2003. The regulations can be found at the following link: http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/index.html?redirect=/clia/ Under CLIA regulations, protocols for patient testing cannot be changed without permission of the laboratory director and any changes to the protocol (including reagents, instruments, testing conditions, etc.) must follow specific regulations. REGULATORY AUTHORITY This acquisition is conducted under the authority of the Federal Acquisition Regulations (FAR) Subpart 13.106-1(b), soliciting from a single source (for purchases not exceeding the simplified acquisition threshold) and only one responsible source and no other supplies or services will satisfy agency requirements. ADDITIONAL INFORMATION Industry Classification (NAICS) Code is 325413, In-Vitro Diagnostic Substance Manufacturing, and the Small Business Size Standard is 500. The acquisition is being conducted under FAR Part 13, Simplified Acquisition Procedures, therefore the requirements of FAR Part 6, Competitive Requirements, are not applicable (FAR Part 6.001). The resultant award will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 05-86 (February 1, 2016). This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement. All responses must be received by February 18, 2016 at 3:00PM EST and must reference synopsis number NHLBI-CSB-(HL)-2016-065-JML. Responses shall be submitted to the National Heart, Lung, and Blood Institute, Office of Acquisitions, COAC Services Branch, 6701 Rockledge Drive, Room 6151, Bethesda, Maryland 20892-7902, Attention: Jonathan Lear. Responses may be submitted electronically to
contact@example.gov. Faxes will not be accepted. Responses will only be accepted if dated and signed by an authorized company representative. "All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency."
