Quality Assurance

Blood banking is a highly regulated industry, and the blood supply has never been safer in history than it is right now. The safety of patients and KBC’s volunteer donors are of utmost importance. Because a physician must prescribe a transfusion, blood is considered a pharmaceutical, and blood centers are regulated by the Food and Drug Administration as pharmaceutical manufacturers. Blood banks must follow stringent guidelines in the collection, processing, testing, storing and transporting of blood products. KBC staff adheres to stringent Standard Operating Procedures and undergoes routine inspections by the Food and Drug Administration, the American Association of Blood Banks, and various state agencies. Also, since some of our leftover plasma is sent to Europe for manufacture into pharmaceutical products distributed in both the US and Europe, we must follow European Union regulations and are inspected and accredited by EU health authorities. The Quality Assurance Department ensures that all rules and regulations are followed and oversees continuous quality improvement efforts at KBC.