Siemens/ ADVIA 2120i w/Dual Aspirator RoHS system.

INTRODUCTIONThis is not a request for a quotation. A solicitation document will not be issued and quotations will not be requested.THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME).The National Institutes of Health (NIH), Clinical Center (CC), Office of Purchasing and Contracts (OPC) on behalf of the Center for Cellular Engineering (CCE), Clinical Center (CC) at the National Institutes of Health (NIH) intends to negotiate and award a contract without providing for full and open competition (including brand-name) to:Siemens Healthcare Diagnostics, Inc.511 Benedict AveTarrytown, NY, 10591-5005United StatesNORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODEThe intended procurement is classified under NAICS code 334516 with a Size Standard 1,000. REGULATORY AUTHORITYThe resultant contract will include all applicable provisions and clauses in effect

through the Federal Acquisition Circular (FAC) 2022-06 May 26, 2022. This acquisition is conducted under the procedures as prescribed in FAR subpart 13-Simplified Acquisition Procedures at an amount not exceeding the simplified acquisition threshold.STATUTORY AUTHORITYThis acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures, Subpart 13.106-1 (b) (1), Soliciting from a single source and is not expected to exceed the simplified acquisition threshold. Contracts awarded using FAR Part 13-Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6-Competition Requirements.GENERAL INFORMATION1. Title: Siemens/ ADVIA 2120i w/Dual Aspirator RoHS system.2. Background Information:  The Center for Cellular Engineering (CCE) is responsible for the manufacture of human cells and tissue-based products utilized in phase I/II clinical protocols for transplantation, adoptive immunotherapy and gene therapy conducted in the Clinical Center at the NIH. Cell processing procedures are tailored to each of the 30 or more different patient-care clinical research protocols supported. Also, regarding Institute research support it:  1)Develops biologics collection and manufacturing processes to support clinical trials, 2) Collects, manufactures and distribute blood components for in vitro research use, 3) Collaboration in the design, planning, execution and data analysis of clinical studies, 4) Collects and manufactures specialized cellular products to support clinical trials and, 5) Develops and evaluate assays for clinical application and biologics safety testing and cellular characterization.The complete cell count (CBC) is needed for infusion, cryopreservation and clinical samples of lot release assays. The hematology analyzer, ADVIA 2120i w/Dual Aspirator – RoHS system is a unique fully automated, high-throughput hematology system that can help us accurately quantify blood cells from CAR-T cells and other engineered products manufactured at CCE, NIH-CC. This instrument will be used for routine clinical lot release assays at CCE.3. Purpose or Objective: The ADVIA 2120i w/Dual Aspirator – RoHS system is fully automated and high-throughput blood testing that bring automated sample preparation, flow cytometry and data analysis into the GMP manufacturing suite.4. Delivery:   90 days A.R .O.  5. CONTRACTOR REQUIREMENTSScope of Work:This acquisition package includes the following:1.            QTY. 1 of Part#11219529 ADVIA 2120i w/Dual Aspirator-RoHS2.            QTY.1 of 3M Multispecies CONV KIT.3.            QTY. 1 Warranty service for (1) ADVIA-2120i w/Dual Aspirator- RoHS for Year 1 through 1.4.            QTY.1 Training slots for the ADVIA- RoHS at the Siemens training facility with reasonable airfare to be paid by Siemens. Training slots shall remain available for 1 years from the date of Equipment installation.5.            Reagent Credit: Hematology - Siemens will issue a reagent credit of $2,000.00 for year 1.6.            Trade in of Advia 2120 SN IR43691531.6. Inspections and Acceptance RequirementsPing Jin from the CC DTM CCE PACT group:  •           Receive ADVIA-2120i w/Dual Aspirator RoHS System and ensure that it was shipped and install under the appropriate conditions•           That the packaging integrity is not compromised•           That all ordered materials have arrived•           That serial numbers match the documentation•           Any discrepancies are reported to Service Chief and Illumina•           Ensure that the Installation and Operational qualification are completed appropriately•           That the ADVIA 2120i w/Dual Aspirator RoHS system is fit for useLogistical Requirements•           All materials will be delivered to theRM#3N317B, Building 109000 Rockville PikeBethesda, MD 20892•           Deliveries are 9 AM to 5:30 PM and must be signed for•           All packaging must be intact and a packing slip with serial numbers and certificates of analysis or conformance must be supplied along with any calibration certificates and operational softwareGovernment ResponsibilitiesThe NIH CC DTM CCE shall inspect shipments upon receipt and report any damage, defects or errors in shipment to the contractor. CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATIONThis system is on site and has been validated for use on CC patients.  It would be detrimental to the government to attempt to change systems and quite impossible as these instruments are proprietary and only distributed by Siemens Healthcare Diagnostics Inc.  With the continuation of using the same supplies will also help reduces the risk of a disruption in patient care. The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted as prescribed in FAR Part 10-Market Research.CLOSING STATEMENTThis 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 a technical proposal, a cost-price proposal, and the period of performance, 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 July 21st, 2022, 11:00 AM Eastern time and must reference solicitation number 22-008634 via email. Responses may be submitted electronically to Ms. Grace Wong-Darko and Malinda Dehner, Contracting Specialist at Grace.Wong-Darko@nih.gov and dehnerm@cc.nih.gov . Fax responses will not be accepted."All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency."