The role of hemovigilance as a mechanism to increase transfusion safety

The complexity of healthcare organizations involves interdisciplinary professional practice, whose common goal is to provide quality products and services that satisfy the customer's and society's expectations. One of the services that comprise this structure is transfusion medicine, which is an essential specialty in the treatment of hematologic malignancies and numerous other clinical and surgical conditions. In transfusion medicine, quality starts with the process of attracting donors and extends to the transfused patient, by ensuring traceability of blood components and derivatives. Despite major advances, transfusion, even with precise indication and correct administration, involves risk to health with the potential of transfusion incidents (TI), whether immediate or delayed. TI are defined as injuries occurring during or after and related to blood transfusion. The professionals involved in prescribing and administrating blood products must be trained to identify signs and symptoms of TI, to manage them and to establish measures to prevent future incidents. Thus, the notification of immediate and delayed TI is essential to minimize these risks. Immediate TI (within 24 hours of transfusion) are the most commonly observed, with an overall occurrence which varies in different services and countries of between 0.5 and 3%; febrile non-hemolytic and allergic reactions are the most frequent. However, health risks, in order of severity, are: acute hemolytic reaction, TRALI, bacterial contamination and volumetric overload. Hemovigilance, developed in the early 1990s in France, has emerged as a tool to improve transfusion safety. In Brazil, a blood-surveillance system was implanted during the restructuring of the National Health Service in 1999 and the goal of the project: "Blood with a guaranteed quality in all its process until 2003" became a reality in 2001. Resolution number 57 of the Agência Nacional de Vigilância Sanitária (ANVISA) defines hemovigilance as "a set of surveillance procedures covering the cycle of blood, from the donation to the transfusion, generating information about adverse events resulting from the donation and the therapeutic use of blood and blood components. This information is used to identify risks, improve the quality of products and processes and increase the donor and patient safety by preventing the occurrence or reoccurrence of these events." Article # 152 stipulates that "Any adverse event that occurs in recipients of blood and blood products should be investigated and reported officially to the responsible authorities using the NOTIVISA system." (6) However, on analyzing the annex of decree 1353 of 13/06/2011 of the Brazilian Ministry of Health, …