NOI to Sole Source.docx

The purpose of this acquisition is to provide HLA typing and antibody screening reagents to the HLA Lab for clinical testing. One Lambda (vendor) will ship reagents included on the quote upon request. The vendor will provide the reagents within 1 week, unless otherwise specified during ordering.

POTS: 26-004204

Description:

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 Institutes of Health (NIH) intends to award a fixed price purchase order to One Lambda, Inc., located at 22801 Roscoe Blvd, West Hills, CA 91304, on a firm fixed price sole source award basis to provide specific HLA typing and antibody screening reagents. The HLA Lab currently uses these reagents to test our patients. The reagents provided by One Lambda have been previously tested in the lab and provide a greater ability to resolve testing ambiguities than other vendors tested. All validation testing has been completed for these reagents so there is laboratory documentation available to confirm the accuracy and precision of these reagents. A change in vendors/reagents would require extensive validation and would take approximately 2 months. This would greatly impact the ability of the HLA Lab to provide timely results. 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 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.

The proposed vendor, One Lambda, is the sole provider of the LABType, LABScreen, and Secore kits. No other vendors would be suitable. These exact reagents are not available from any other vendor and have been quality control tested to validate their performance. To change vendors for a similar reagent kit would require extensive testing and validation of the new reagents which would impact patient care.

This acquisition is being conducted using policies unique to the Federal Acquisition Regulation (FAR) Part 13 – Simplified Acquisition Procedures, Subpart 13.106-1(b)(1), For purchases not exceeding the simplified acquisition threshold (SAT), contracting officers may solicit from one source if the contracting officer determines that the circumstance of the contract action deem only one source reasonably available. Contracts awarded using FAR Part 13-Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6-Competition Requirements.

Interested parties may identify their interest and capabilities in response to this posting. The determination by the Government not to compete the proposed requirement based upon responses to this notice is solely within the discretion of the Government.

Comments to this announcement, referencing this posting number, may be submitted to the NIH, Clinical Center, Office of Purchasing and Contracts, prior to the closing date specified in this announcement, to the attention of Huda Malik, Contract Specialist via email to huda.malik@nih.gov by March 30, 2026 at 12pm EST.