NanoString Tech/ nCounter Max Analysis System.
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 Transfusion Medicine (DTM), 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:
NanoString Technologies, Inc.
530 Fairview Ave N
Seattle, WA, 98109-5553
NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE
The intended procurement is classified under NAICS code 334516 with a Size Standard 1000.
REGULATORY AUTHORITY
The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2005-100, August 22, 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.
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: NanoString Tech/ nCounter Max Analysis System.
2. Background Information: The CCE is an AABB accredited cellular therapy laboratory whose central mission is to provide services to the NIH Institutes to support more than 50 intramural clinical trials. These services include (1) development, evaluation, and validation of investigational new drugs (INDs) for cellular therapies and (2) manufacture of cellular therapy products for approved clinical trials. The majority of these trials are early phase (I/II) trials not intended to result in the development of a commercial product. To provide these services, CCE operates a core facility for the manufacture, storage, and distribution of cellular therapy products. CCE manufactures cellular therapy products from more than 800 collections from patients or healthy donors per year. The products manufactured by the laboratory are used to treat NIH CC patients with cancer, hematological malignancies, marrow failure, genetic immune disorders and autoimmune diseases. All products are manufactured using good manufacturing practices (GMP). The NIH protocols are institutional review board (IRB) approved and in the case of INDs, approval by the US Food and Drug Administration (FDA) for treatment of human subjects. Each subject must consent to participate in a NIH Clinical Research Study.
3. Purpose or Objective: CCE uses the nCounter® Analysis System and associated reagents to operate the system are only available from NanoString Technologies. The The nCounter® Max employs a novel digital barcode technology. This barcodes hybridize with target molecules and unique digital barcodes then directly counted using single-molecule imagining to yield precise and sensitive quantification. Up to 800 target can be measured simultaneously.
Boost Productivity: Intuitive workflow with only fifteen minutes of hands-on time from sample to data.
Simplify Analysis: Results generated as direct counts and reported in a standard CSV file.
Detect Small Fold Changes: Eliminate cDNA synthesis, amplification, and library prep so you experience less technical variation in your assay and reduce the need for experimental replicates.
Secure Access: An enterprise software package is included for laboratories that require enhanced security. Control user access, automate data flow, and generate audit logs.
Unattended Data Collection: The Digital Analyzer can load up to six cartridges at a time for unattended scanning overnight. Random access enables users to pause data collection to load or remove additional cartridges without waiting for the run to finish.
4. Delivery: approximately 4 - 8 weeks A.R.O.
CONTRACTOR REQUIREMENTS (SCOPE OF WORK)
1. The contractor will supply the specified amount of materials/equipment.
2. The materials to be procured are:
-nCounter Max Analysis System NCT-SYST-200
-nCounter Intall & Train Kits DA Install, PS Install & Train
-Uninterruptible Power Supply UPS-USDM-110
-Shipping & Handling
3. The Contractor shall provide technical support for these materials and their performance
Characteristics at no cost to the government.
Delivery Schedule:
These medical supplies/equipment will be shipped delivery Monday through Thursday 8:00 AM to 4:00PM to:
NIH/CC/DTM/Center Cellular Engineering
10 Center Drive
Bldg. 10/ Rm. 3N317B
Bethesda, MD 20892-1288
Attention: Ping Jin or RongYe Shi
The contractor shall bear the cost of replacement for reagents found to be damaged or defective upon receipt by NIH or for incorrect or incomplete shipments.
Government Responsibilities
1. The Center Cellular Engineering shall use the instrument/reagents in accordance with manufacturer's package inserts and approved IND/IDE uses if applicable.
2. The NIH CC Center Cellular Engineering 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) DETERMINATION
This 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 Veterans Healthcare Supply Solutions. With the continuation of using the same system 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 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 22nd, 2019, 10:00 AM Eastern time and must reference solicitation number 19-009599. Responses may be submitted electronically to Mrs. Grace Wong-Darko, Contracting Specialist at Grace.Wong-Darko@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."
Grace P. Wong-Darko, Contract Specialist, Phone 3014961199, Email wongdarkogp@nih.gov
