Sebia reagents, quality control and supplies that are compatible with the Sebia Hydrasys 2 electrophoresis instruments.

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:

SEBIA, INC.

1705 CORPORATE DR STE 400

NORCROSS, GA, 30093-2991,

UNITED STATES

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE

The intended procurement is classified under NAICS code 325413 with a Size Standard 1,250 employees.

REGULATORY AUTHORITY
The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2020-02 December 23, 2019. This acquisition is conducted under the procedures as prescribed in FAR Subpart 13.5 - Simplified Procedures for Certain Commercial Items and is expected to exceed the simplified acquisition threshold ($250,000.00).

STATUTORY AUTHORITY
This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures, Subpart 13.5 - Simplified Procedures for Certain Commercial Items. Contracts awarded using FAR Part 13-Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6-Competition Requirements.

GENERAL INFORMATION

1. Title: Sebia reagents, quality control and supplies that are compatible with the Sebia Hydrasys 2 electrophoresis instruments.
2. Background Information: The Department of Laboratory medicine 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. Clinical testing in the Special Chemistry service is critical for monitoring disease states as well as screening for acceptance into NIH research protocols.

3. Purpose or Objective: The Department of Laboratory Medicine has a need for Sebia reagents, quality control and supplies that are compatible with the Sebia Hydrasys 2 electrophoresis instruments used in the Department of Laboratory Medicine. Several Clinical Center protocols require testing performed with these reagents.

Sebia Hydrasys B1/B2 reagent kits are used for the separation and quantitation of proteins in human serum and urine on agarose gels, and provide enhanced resolution and sensitivity for monoclonal band detection. The Sebia Hydrasys IF reagent kits are designed for detection and identification of monoclonal proteins by immunofixation electrophoresis. The protein detection and identification provided by the Sebia B1/B2 and IF kits are necessary for monitoring patients with B cell malignancies such as Multiple Myeloma and Chronic Lymphocytic Leukemia, who participate in Clinical Center treatment protocols.

The Hydrasys Isofocusing reagent kits are designed for qualitative detection and identification of oligoclonal bands in the electrophoretic patterns of Cerebral Spinal Fluid. These specific reagent kits are indicated for monitoring diseases of the central nervous system in Clinical Center patients.

The Sebia reagents kits are the only reagents compatible with the Sebia Hydrasys 2 analyzers that are in use in the Department of Laboratory Medicine. No other vendor reagents or supplies can be used with the Hydrasys 2 system.

4. Period of Performance: One BASE (1) year beginning on or around 3/15/2020 with four (4) additional option periods of one (1) year each.

CONTRACTOR REQUIREMENTS (SCOPE OF WORK)

The contractor will supply electrophoresis reagents, quality control and supplies for the continuation of laboratory testing in support of NIH Clinical Center patient care. The reagents will be ordered as needed by the lead technologist in the Special Chemistry section of the Department of Laboratory Medicine.

The following reagents, kits and QC are required:

Product Product Description

4355 HYDRAGEL 9 CSF ISOFOCUSING (90

4809-SM HYDRAGEL 9 IF (SM) WO/AS (90T)

4141 HYDRAGEL 30 PROTEIN B1 + B2 (3

4804-SM HYDRAGEL 4 IF (SM) WO/AS (40T)

4815-SM FIXATIVE AND IF ANTISERA (SM)

4787 HYPERGAMMA CONTROL SERUM (5x1m

4785 NORMAL CONTROL SERUM (5x1 ml)

4353 HYDRAGEL 3 CSF ISOFOCUSING (30

4121 HYDRAGEL 15 PROTEIN B1 + B2 (1

4743 CSF ANTI-IGG (.66 ml)

4794 CSF CONTROL (0.5ml)

4541 HYDRASYS WASH SOLUTION (10 VIA

4836-SM BJ ANTISERA SET Kf-Lf (SM)

4540 DESTAIN SOLUTION (10 VIALS)

4554 AMIDO BLACK SET STAIN/DILUENT

4587 Fluidil

4613 Anti D

4614 Anti E

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

This is a requirement for reagents from the manufacturer. There is only one known vendor that can provide the reagents and no authorized distributors. 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 January 29, 2020, 03:00 PM Eastern time and must reference solicitation number 20-000001. 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."