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Reagents and Supplies for the BioMerieux BacT/ALERT Dual-T instrument


Maryland, United States
Government : Federal
RFP
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INTRODUCTION
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 Department of Laboratory Medicine (DLM), 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:
BIOMERIEUX , INC.
100 RODOLPHE ST
DURHAM, NC, 27712-9402,
UNITED STATES

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE


The intended procurement is classified under NAICS code 325413 with a Size Standard 1250 employees.



REGULATORY AUTHORITY
The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2005-101 October 26, 2018. 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 ($250,000).



STATUTORY AUTHORITY
This 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 INFORMATION


1. Title: Reagents and Supplies for the BioMerieux BacT/ALERT Dual-T instrument
2. Background Information: The Department of Laboratory Medicine serves as the clinical laboratory of the NIH Clinical Center. It provides laboratory support for patient care and research protocols and performs research and training in disciplines of Clinical Pathology. In doing so, DLM provides state-of-the-art laboratory testing in support of Clinical Center patient care and serves as a center of excellence in research and training in laboratory medicine, particularly in areas, which utilize the unique strengths of the National Institutes of Health.
3. Purpose or Objective: The purpose of this procurement is to supply reagents for sterility testing of cell therapy products for the period of performance. These reagents allow for the culture of product contaminants to ensure the safety of the product prior to infusion into a patient. The use of these items in conjunction with the BioMerieux BacT/ALERT Dual-T instrument has allowed us to detect organisms in biopharmaceutical products efficiently and accurately. Due to regulatory requirements and rigorous validation testing performed in lab, these reagents are the only ones that can meet the needs of the testing that we conduct in the Sterility Testing Service, DLM, CC, NIH.


4. Period of Performance: One (1) year base with two additional option periods of one (1) year each starting on or around 6/1/2019.


CONTRACTOR REQUIREMENTS
The laboratory will contact the vendor and place orders on an as needed basis. Products include the following:
259785 BACT/ALERT I NST
259786 BACT/ALERT I AST
412990 BACT/ALERT I FA PLUS
412991 BACT/ALERT I FN PLUS
The laboratory will contact vendor to place orders over the course of the time outlined in the period of performance. Vendor will send furthest out date of reagents and supplies for each order.


CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION


The intended sole source is the only known source that can provide these reagents. The reagents are specific for the existing instrumentation and clinical tests which undergone rigorous laboratory validation. These reagents are therefore the only ones that can meet the regulatory cGMP standards for product sterility testing in DLM. 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 STATEMENT


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 a technical proposal, a cost-price proposal, 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 May 27, 2019, 10:00 AM Eastern time and must reference solicitation number 19-007834. Responses may be submitted electronically to Mr. Christopher Lauver, Contracting Specialist at christopher.lauver@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."


Christopher D. Lauver, Contract Specialist, Phone 301-594-5914, Email christopher.lauver@nih.gov

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