United States - Veterans HSS / 60 Cases of TERUMO BCT Elutra Cell Separation System, Disposable Tubing Set

Description

Added: Apr 04, 2019 3:18 pm

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:
Veterans Healthcare Supply Solutions, Inc.
13949 ALVAREZ RD. STE 300
JACKSONVILLE, FL, 32218-9433
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: Veterans HSS / 60 Cases of TERUMO BCT Elutra Cell Separation System,
Disposable Tubing Set.
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 kits are used with Terumo BCT cell separators/washers instruments and are used to separate various blood/blood components from one another. This then permits the specific type of cells of interest to be taken and further manufactured and returned to the patient. This applies to monocytes, for example, with can be withdrawn and made into (manufactured) dendritic cells or lymphocytes which are manufactured to mono sans lymphocytes and reinfused into the patient. If we were not able to procure this, the protocols would have to be discontinued as the Center of Cellular engineering would not be able to manufacture blood products required for cancer vaccine patients. This could be fatal.
4. Period of Performance: Base year approximately start date on or around 6/1/19 to 5/31/20.
CONTRACTOR REQUIREMENTS (SCOPE OF WORK)
1. The disposables used on the Elutra semi-automated centrifuge-based device that utilizes continuous counter flow centrifugation is used to separate cells based on their size, shape and density.
2. The contractor will supply sufficient disposables to process approximately 200 cellular therapy products per year.
3. Shelf Life-Minimum - Shelf life of disposables shall be at least 3 months from date of delivery at the DTM Cell Processing Laboratory.
4. The disposables include to those listed below:
Elutra Cell Separation System Disposable Tubing Set.

5. The Contractor shall supply technical support for all supplies and their performance characteristics at no additional cost to the Government.
Period of Performance
The performance for these product is one year: 06/1/2019-05/31/2020
Delivery Schedule:
June 2019 - January 2020: 5 cases/month
February 2020 - May 2020: 4 cases/month
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. 3C720
Bethesda, MD 20892-1288
Attention: Timmy Ton or John Salsgiver
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 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 April 15th, 2019, 3:00 PM Eastern time and must reference solicitation number 19-008558. 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."

Opportunity closing date

15 April 2019

Value of contract

to be confirmed