Hemovigilance in the United States of America

Abstract

Although hemovigilance is not a word used commonly in the United States, the concept of monitoring morbidity associated with blood transfusion is accepted widely. Currently, quality management focuses on error avoidance rather than error detection in both the "manufacturing" and "clinical" aspects of blood banking. "Manufacturing" is regulated predominantly by current Good Manufacturing Practices while clinical transfusion medicine follows clinical practice guidelines. There are multiple overlapping mechanisms for quality assurance and error reporting among governmental, professional, and non-profit regulatory agencies. The strategies of each stress the on-going need for a systems approaches to preventing errors.

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