Hemovigilance Today - The Facts and the Fictions

Total quality management in blood collection and transfusion requires monitoring risks from ‘vein-to-vein’ i.e., from blood collector and manufacturer to transfusion at the bedside and back. Hemovigilance is a set of surveillance procedures covering the entire transfusion chain from the follow-up of recipients of transfusions to the donation of blood and its components as a total quality management assessment tool. Hemovigilance was initiated in Japan in 1993 and in France in 1994 and has been adopted since in many countries throughout the world. Some of these systems reside within and are mandated by a national ministry of health, while others are primarily organized through professional societies or the country’s blood system. The main objective should be sharing of data to all concerned.
A good hemovigilance system should include data collection (including both numerators and denominators), analysis by experts, production of recommendations to improve practice, communication back to the front line, and education. Clear definitions are essential, and it is critical that experts examine each reported case carefully. Well-established systems have demonstrated, in various ways, how hemovigilance data can improve outcomes for patients. The ability to monitor outcomes of interventions is critical in improving safety. Likewise, donor systems can assist in reducing errors and accidents in the donation process. As a matter of fact, hemovigilance should be an integral part of the system wherever transfusion medicine is practiced, and should also be expanded to include biovigilance for other substances of human origin such as cells, tissues and organs. It is a fiction to believe that simple registration of adverse transfusion effects is hemovigilance, in the absence of a mature quality system and related quality system management.