SAM #NOI-OD-26-004204

The National Institutes of Health (NIH) Clinical Center's Human Leukocyte Antigen (HLA) Laboratory in Bethesda, MD, is seeking to procure specialized HLA typing and antibody screening reagents through a sole source award to One Lambda, Inc. - Government Buyer: - National Institutes of Health (NIH), Clinical Center, Office of Purchasing and Contracts - OEM Highlight: - One Lambda, Inc. is the sole manufacturer and provider of the required reagents - Products/Services Requested: - HLA typing and antibody screening reagents - LABType kits - LABScreen kits - Secore kits - These products are used for clinical diagnostic testing, patient care, and transplant protocols - Unique/Notable Requirements: - Only One Lambda reagents are validated for use in the NIH HLA Lab - Switching to another vendor would require extensive revalidation and could disrupt patient care - Reagents must be delivered within 1 week of ordering unless otherwise specified - No other OEMs or vendors are considered suitable for this procurement - Place of Performance: - NIH Clinical Center, Bethesda, MD

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.