Human Leukocyte Antigen (HLA) Kits for Transfusion Medicine

This is a notice of intent, not a request for a quotation. A solicitation document will not be issued and quotations will not be requested.

The National Institute of Health, Clinical Center (CC) intends to award a one year fixed price Indefinite Delivery Indefinite Quantiity (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 1, 2019 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.

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.

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 Acquidition procedures are exempt from the requirements of FAR 6, but still require a justification using the format of FAR 6.302-2.
Interested concerns capable of providing the same or similar products or services as described in this notice may submit a capability statement outlining their capabilities. Capability Statements must be received within the time set forth in this synopsis to be considered by the Government. A determination to compete this proposed contract based on responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement.
Each response should include the following Business Information:
a. DUNS.
b. Company Name, address, POC, Phone and Email address
c. Current GSA Schedules or NAICS codes appropriate to this Award.
d. Type of Company (i.e., small business, 8(a), woman owned, hubZone, veteran owned, etc.) as validated in System For Award Management (SAM). All offerors must register on the SAM located at http://www.sam.gov/portal/SAM/#1
e. Capability Statement

The total dollar value of the acquisition shall not exceed $750,000.00.

Comments to this announcement may be submitted to the Clinical Center, Office of Purchasing and Contracts, prior to the closing date specified in this announcement, electronically to the attention of Malinda Dehner, Contract Specialist, dehnerm@cc.nih.gov by the due date and time marked in this notice.

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