The Department of Health and Human Services, specifically the National Institutes of Health (NIH), intends to negotiate a sole source contract with Qiagen for the procurement of EZ1 & 2 DNA Blood Isolation Kits and DNA Tissue Kits. These kits are critical for the ongoing clinical research and patient care at the NIH Clinical Center, particularly for Human Leukocyte Antigen (HLA) matching in transplant patients and potential donors. The kits have been extensively tested and are essential for providing high-quality DNA samples necessary for critical Next Generation Sequencing, with an estimated contract value of $29,166.25. Interested parties may submit capability statements by email to valerie.gregorio@nih.gov by 11:00 AM EST on December 13, 2025, referencing NOI-CC-26-000013.

JOFOC - Qiagen HLA Stndng order - FY26 (1).docx

The National Institutes of Health Clinical Center (NIHCC) Human Leukocyte Antigen (HLA) Lab requires approval for a sole source acquisition of DNA isolation kits from Qiagen, per FAR 6.302-1. These kits are essential for ongoing patient care, specifically for HLA matching of transplant patients and potential donors, with an estimated value of $29,166.25. The justification states that current lab instrumentation is only compatible with Qiagen kits, which have been extensively tested and proven to provide the high-quality DNA samples necessary for critical Next Generation Sequencing. Using an inferior product could delay lifesaving transplants. No alternative vendors for Qiagen products are known, and the anticipated cost is deemed fair and reasonable based on prior orders. The NIHCC HLA Lab emphasizes that inability to acquire these kits would disrupt patient testing, and switching to another source would involve months of retesting, staff retraining, and procedural changes, causing significant harm to ongoing operations.

This is a Notice of Intent, not a request for proposal. The National Institute of Health, Clinical Center (NIH-CC) intends to negotiate on an other than full and open competition basis with the following vendor: Qiagen.

Justification:

This action in accordance with IAW FAR 6.302-1: Sole Source: Only One responsible source/Quality of product required for on-going clinical research is based on the need to procure testing kits for ongoing patient care use.

The HLA Laboratory provides high and low resolution HLA typing for patients at the NIH Clinical Center. These are oftentimes for patients who are critically ill. These kits have been extensively tested by the HLA Lab to provide the highest quality DNA samples to be used in downstream testing.  This contract will ship the testing kits on an as needed basis throughout the year and avoid the possibility of running out of kits.  This number of kits is expected to provide sufficient tests to last one year at the current rate of use.

The estimated value of this obligation will be $28,886.25 plus shipping (280.00) = $29,166.25

The statutory authority for this sole source requirement is 41 U.S.C. 1901 (a) (1) as implemented by FAR 13.106-1 only one responsible source and no other supply of service will satisfy agency requirements. THIS IS NOT A REQUEST FOR PROPOSAL.  All responsible sources that could provide the required may submit a capability statement that will be considered by email (subject line to reference NOI-CC-26-000013) by 11:00 AM eastern standard time on 12/13/2025 to: valerie.gregorio@nih.gov

All responses received by the closing date of this synopsis will be considered by the Government.  A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government.

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