Quality systems and total process control in blood banking.

Blood banking has dramatically changed in the past few years. Is the old business hierarchy and medical model for management still workable? How do we want to organize our work today for success in the future? Implementation of quality systems may seem overwhelmingly complex at this time to many blood banking establishments. However, by methodically adhering to the requirements of organization development described in this review, blood centers can achieve goals of quality improvement and TPC. The FDA and the pharmaceuticals and medical device industries have set the direction and provided guidance to blood establishments. The AABB, American Society for Quality Control, the American Society for Training and Development, and numerous other professional organizations can contribute information and materials. The FDA's document on quality assurance and the CFR are the basic texts guiding the approach presented in this paper. The organization's structure and processes may need to be reengineered to meet the requirements of a culture based on quality and process control.