Biovigilance | INSPQ

That biovigilance consists in monitoring and preventing the risks related to the use of products derived from the human body (organs, blood, cells, tissues, breast milk). It helps ensure the optimal security of supply that the use of these human products for therapeutic purposes requires.

L’haemovigilance is the part of biovigilance related to the risks associated with 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 aftercare of the recipients.

All activities related to the transfusion of blood products conform to transfusion practices governed by various bodies, standards and processes..


The mandates given by the Ministère de la Santé et des Services sociaux (MSSS) through the Department of Biovigilance and Medicinal Biology to consolidate and develop Quebec’s public health know-how in the field of “biovigilance” are as follows:

  • Evaluation Errors and transfusion reactions
  • management Report of Transfusion-Related Adverse Events (REIAT)
  • Analyze Data on the use of blood products, including non-specific immunoglobulins (Ig)
  • Support of expertise

Essentially the work of the INSPQ team two axesdescribed below:

Monitoring errors and transfusion reactions

Reporting of transfusion reactions and errors is one of the essential elements of Quebec’s haemovigilance. It includes activities resulting from the therapeutic use of labile blood products (such as red blood cells, platelets, cryoprecipitates, frozen plasma) and of stable blood products (fractionated products from plasma such as albumin, immunoglobulins intravenously, intramuscularly or subcutaneously and certain coagulation products such as factor VIII and IX, fibrinogen and antithrombin III).

Transfusion errors and reactions reported to the hemovigilance system are the subject of an annual provincial report. This report includes data on errors detected before or after the start of a transfusion, errors that resulted in administration of a product when it should not have been (APNDE errors), and adverse transfusion reactions in recipients of labile and stable blood products (number, incidence rates). It also presents the evolution of transfusion reaction rates in Quebec since 2000.

Note : The title of the surveillance reports has evolved over time, from “Transfusion incidents and accidents reported to the Quebec Hemovigilance System – Year 20XX” (2000-2017) to “Surveillance of transfusion errors and reviews in Quebec – Year 20XX” (2018 and later). ).

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

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

The annual reports provide a descriptive analysis of the use of non-specific immunoglobulins by Quebec healthcare facilities 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 Transfusion Safety Officer
  • Melissa Trudeauresearch technician
  • Giles LambertMD, Biovigilance Consultant
  • Anne KimptonM.Sc., Head of Scientific Unit

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

#Biovigilance #INSPQ

Leave a Comment

Your email address will not be published.