One Lambda/ Various reagents.

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 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:

One Lambda Inc.

21001 KITTRIDGE ST

Canoga Park, CA, 91303-2801    

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) 2020-4, January 15, 2020.  

STATUTORY AUTHORITY
This acquisition is being conducted using policies unique to FAR Part 13.5 Simplified Acquisition for Certain Commercial Items and specifically FAR 13.501(a) Special Documentation Requirements, Sole source (including brand name) acquisitions where acquisitions conducted under Simplified Acquisition procedures are exempt from the requirements of FAR 6, but still require a justification using the format of FAR 6.302-2. The total dollar value of the acquisition shall not exceed $7,000,000.00.

GENERAL INFORMATION

1. Title: One Lambda /Various reagents.

2. Background Information: The function of the Human Leukocyte Antigen Laboratory (HLA) of the Department of Transfusion Medicine, CC is to (1) provide clinical diagnostic laboratory testing for patients in the Clinical Center to facilitate possible transplant or enrollment into an appropriate protocol for the patient’s particular condition; (2) to conduct clinical consultations for NIH Clinical Center physicians in the management of patient care in regards to potential transplant scenarios; (3) to maintain accreditation through various accrediting agencies in order to provide quality results (4) to conduct research in the development of new diagnostic laboratory tests (5) to facilitate the support and development of protocols which involve HLA testing and the implications for patient care.

3. Purpose or Objective: The National Institute of Health, Clinical Center (CC) intends to award a one year fixed price Indefinite Delivery Indefinite Quantity (IDIQ) contract to One Lambda, Inc., Canoga Park, California 91303-2801, DUNS# 118289289 for the acquisition of LabType SSO/PRA/Class Typing Kits.

The proposed vendor, One Lambda, Inc., is the only manufacturer of the various LabType SSO/PRA/Class Typing kits. These kits are used for routine Human Leukocyte Antigen (HLA) testing and HLA antibody screening utilizing the Luminex methodology as 510K FDA cleared products. While other platforms may be available, these platforms have not been found to have all the various types of kits needed for HLA testing. Any change to another platform would require validation to ensure the kits and testing work as stated, which would take months to perform. It is imperative due to the diagnostic nature of the testing, that diagnostic test kits are not changed without proper testing. These items need to be awarded before June 10, 2020 to ensure no disruptions in HLA testing.

In addition, One Lambda is the only company which provides a LabType typing reagent for high resolution Class II DRB1 Loci testing. This level of resolution is necessary to provide information to several primary investigators at NIH who are involved with numerous protocols, including transplantation protocols.

4. Period of Performance: Base plus 4 option years estimate beginning in June 2020.

CONTRACTOR REQUIREMENTS (SCOPE OF WORK)

1. Requirements-The following reagents will be purchased with the breakdown of estimated annual price.  Either reagents listed or those of an equivalent upgrade will be included in this contract.

Reagent Name                                   Catalog #                    Estimated Quantity

LABType A Locus                               RSSO1A                                      35

LABType B Locus                               RSSO1B                                     35

LABType C Locus                               RSSO1C                                     35

LABType DRB1 Locus                       RSSO2B1                                  30

LABType DQA/B1 Loci                      RSSO2Q                                    30

LABType DRB345 Loci                      RSS02345                                 30

LABScreen PRA Class I                         LS1PRA                                      26

LABScreen PRA Class II                        LS2PRA                                      24

LABScreen Single Antigen Class I    LS1A04                                      14

LABScreen Single Antigen Class II   LS2A04                                      6

Secore A                                                     5300025                                     8

Secore C                                                     5320025                                     2

Secore B                                                     5311025D                                 2

Secore DRB1                                            A15571                                      20

Secore DQB1                                           5341025D                                  6

Secore DPB1                                            5351025                                     6

DNA Wipe Test                                        789991                                        5

SAPE                                                           LT-SAPE                                     18

ADSORB                                                    ADSORB                                     7

LABScreen Negative Control            LS-NC                                          10

PE Congugated Goat Anti-Human IgG     LS-AB2                              3

Lambda Antigen Tray Class I and II            LAT-1240                         2

KIR SSO Genotyping Test                    RSSOKIR                                    4

KIR Genotyping SSP Kit                        54410D                                     3

FREIGHT

2. Deliverables:   Reagents will be delivered according to need within 3 days of order placement.  Volumes indicated on the quote are for estimated use ONLY – there is no requirement to purchase a predetermined number of any kit/reagent.

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 11, 2020, 10:30 AM Eastern time and must reference pre-solicitation number 20-007294. 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."

Small businesses are encouraged to respond to this notice if they are capable to meet the needs of this requirement. Written responses to this notice shall contain sufficient documentation to establish bonafide capability to fulfill the requirement.