Evolution of quality management: integration of quality assurance functions into operations, or "quality is everyone's responsibility".

The management of quality in the Division of Transfusion Medicine at our institution has undergone a lengthy, sometimes painful but always progressive evolution over nearly four decades. Initially, it consisted of one laboratory technologist who was assigned the task of performing certain basic QC checks on a predetermined list of laboratory, collection, and processing steps. This technologist reported directly to the medical director. The tasks gradually grew in volume and complexity so that a four-person quality unit was established, administratively quite separate from the operations and accountable only to the Medical Director. The next stage in the evolutionary process was more revolutionary in scope because it involved a comprehensive cultural shift toward the concept of "quality is everyone's responsibility." The evolutionary process in our institution to date and the planning and organization involved in the direction and management of the evolution itself are described.