The initiation of testing for antibody to HIV in the donor blood supply opened a new era of operational, safety, and legal complications for facilities in which transfusion medicine is practiced. Mounting dissatisfaction with increasing incidents of questionable release of blood forced regulators to take tougher actions. Blood banks were surprised and concerned that their practices could no longer effectively ensure blood safety. Concurrently, US businesses and manufacturers were looking for new answers regarding the question of improved quality in goods and services. The progression from quality control to quality systems is reviewed. In addition, where transfusion medicine is today, and where it has yet to go, as well as the tools available to make the transition, are discussed.
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