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.