Biovigilance | INSPQ

The biovigilance consists of monitoring and preventing the risks associated with the use of products derived from the human body (organs, blood, cells, tissues, breast milk). It contributes to ensuring optimal safety of care that requires the use of these human products for therapeutic purposes.

L’haemovigilance is the part of biovigilance that applies to the risks inherent in the transfusion of blood products and their derivatives. It is based on a continuous and structured monitoring system for all procedures and activities ranging from the collection or donation of blood and/or its components to the follow-up of recipients.

All of the activities surrounding the transfusion of blood products comply with transfusion practices, which are governed by various committees, standards and processes..


The mandates given by the Ministère de la Santé et des Services sociaux (MSSS), via the Biovigilance and Medical Biology Department, for the consolidation and development of Quebec expertise in public health, in the “biovigilance” sector, are following:

  • Evaluation errors and transfusion reactions
  • Management Report of Adverse Events Associated with Transfusion (REIAT)
  • Analyse blood product usage data, including non-specific immunoglobulins (Ig)
  • Support d’expertise

The work of the INSPQ team essentially two axesdescribed below:

Monitoring errors and transfusion reactions

The reporting of transfusion reactions and errors is one of the essential elements of haemovigilance in Quebec. It covers activities arising from the therapeutic use of labile blood products (such as red blood cells, platelets, cryoprecipitates, frozen plasma) and those of stable blood products (fractionated products derived from plasma such as albumin, intravenous immunoglobulins , intramuscular or subcutaneous, and certain coagulation products such as factors VIII and IX, fibrinogen and antithrombin III).

Transfusion errors and reactions reported to the haemovigilance system are the subject of a provincial report published annually. This report includes data on errors detected before or after the start of a transfusion, errors resulting in the administration of a product that should not have been (APNDE errors), as well as adverse transfusion reactions in recipients of labile and stable blood products (numbers, incidence rates). It also presents the evolution of transfusion reaction rates in Quebec since 2000.

To note : The title of the surveillance reports has evolved over time, from “Transfusion incidents and accidents reported to the Québec haemovigilance system – Year 20XX” (2000-2017) to “Surveillance of transfusion errors and reactions in Québec – Year 20XX” (2018 and later).

Use of non-specific intravenous (IVIg) and subcutaneous (SCIG) immunoglobulins

Immunoglobulins (Ig) are blood products prepared from plasma obtained from a large number of carefully selected donors. Non-specific immunoglobulins play an important role in defense against pathogens. Immunoglobulins are mainly used in immunology, hematology and neurology. They are also often used for unrecognized purposes for the treatment of diseases that are immune-mediated or attributable to an unknown pathogenic mechanism.

The annual reports provide a descriptive analysis of the use of non-specific immunoglobulins by Quebec healthcare establishments, according to data entered into the Trace Line system. This database documents transactions related to blood bank activities and ensures product traceability. These portraits highlight certain elements for the efficient management of Ig in Quebec.

  • Karl Itaj NawejM. Sc., Scientific Advisor
  • Sandie BriandPh.D., Specialized Scientific Advisor
  • Ginette Labonteclinical officer in transfusion safety
  • Melissa Trudeauresearch technician
  • Gilles LambertMD, biovigilance consultant
  • Anne KimptonM. Sc., Head of Scientific Unit

  • MSSS
  • Hema-Quebec
  • Canadian Standards Association (CSA Group)
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