ARCHIVED - Summative Evaluation of the Blood Safety Contribution Program - Final Report

II. Blood Safety Contribution Program

Overview of Hemovigilance

Blood transfusion, like other medical procedures, carries some risk of adverse events among recipients. These include both transmission of infectious diseases and noninfectious adverse events. The latter may occur as a result of errors in handling or administering blood and blood products. Currently, as a result of donor screening and new test procedures, the risk of transmission of known infectious agents is extremely low; however, because blood is a biological product, unknown and emerging pathogens will always pose a threat to its safety.

Hemovigilance was introduced as a safety concept in Europe in the early 1990s in response to Human Immunodeficiency Virus (HIV) (Faber, 2003). Before blood safety surveillance systems were introduced, there was no way to track transfusion outcomes reliably (AuBuchon & Whitaker, 2007). There are many definitions of the term, and the meaning varies slightly from one jurisdiction and system to the next (Engelfriet & Reesink, 1999; Faber, 2003; Faber, 2000). The following definition of hemovigilance is from the Guide to the Preparation, Use and Quality Assurance of Blood Components (2007):

As implied in the definition, hemovigilance monitors blood through the whole ‘blood transfusion chain’, from the donor on to the recipient (Robillard, 2006). The scope of hemovigilance varies by jurisdiction (Robillard, 2006). For example, in Europe only fresh blood components are included in hemovigilance activities, while in Canada hemovigilance activities include both fresh blood components and plasma derivatives (Robillard, 2006). Hemovigilance can also include errors and near misses (Robillard, Chan & Kleinman, 2004).

It is worth noting that very few surveillance systems monitor patient outcomes associated with cells, tissues and organs (CCDT, 2008). Comprehensive surveillance associated with these biological products (in addition to blood products) is referred to as “biovigilance”.