Héma-Québec priority is to supply Quebecers with safe and optimal-quality products. We are always working to comply with the highest standards. Héma-Québec has become synonymous with safety, particularly through the adoption of several new safety measures since its creation in 1998.
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- Safety measures in place
- Blood management in Québec
- Licence and agreement
- Compensation program for victims of a product distributed by Héma-Québec
- A, B, O
- RH factor
- red-cell antibodies
- cytomegalovirus (CMV), applied to certain blood bags
- hepatitis B
- hepatitis C
- West Nile virus (WNV)
- HTLV virus
- HIV (AIDS virus)
We test approximately one million test specimens every year.
Each test stage is controlled and verified in order to ensure the quality of the results sent to the PROGESA blood management software, which will match each of the results with the donation involved.
If the component does not meet standards (for example, if the analysis has detected an antibody to a virus or if a nonconformity has been detected), a label indicating that the contents are a biohazard is produced. This biohazardous material will be destroyed.
The components that are compliant will be stored and made available to meet the needs of patients in hospitals.
New Safety Measures
Héma-Québec has become synonymous with safety, particularly through the adoption of several new safety measures since its creation in 1998:
- June 1999: systematic leukodepletion before storage of allogenic blood donations, with filters that remove leukocytes (white blood cells) while being permeable for red blood cells and platelets
- November 1999: introduction of PROGESA blood management software, making operations even safer and more efficient
- November 1999: introduction of nucleic acid testing to detect the hepatitis C virus
- January 2001: introduction of nucleic acid testing to detect HIV, the virus responsible for AIDS
- March 2001: received accreditation from the American Association of Blood Banks
- May 2002: consolidation of all Montréal activities in modern facilities, including a new structure that meets production and safety requirements
- May 2002: introduction of PRISM® high-volume technology that enables several screening tests to be conducted simultaneously, the automation of operations previously carried out manually, and the increase of HBsAg test sensitivity
- February 2003: introduction of a new blood collection device that includes a bypass pouch for the first few millilitres of blood, which can contain bacteria from the area where the needle is in contact with the skin
- March 2003: establishment of a system for detecting bacteria in apheresis platelets
- April 2003: introduction of the anti-HBc test for detecting the hepatitis B virus
- June 2003: introduction of nucleic acid testing (experimental test, experimental testing authorization request phase) for detecting the West Nile virus
- Addition of various donor qualification criteria aimed to temporarily or permanently prohibit blood donation by individuals at risk of being infected by (or exposed to) illnesses that may be transmitted by transfusion. These qualification criteria are continuously reviewed and updated. For example:
- September 1999, October 2000, and October 2001: introduction of qualification criteria related to variant Creutzfeldt-Jakob disease
- April 2003: introduction of qualification criteria in respect to severe acute respiratory syndrome (SARS)
- December 2002 and June 2003: introduction of qualification criteria related to the West Nile virus
- 2004-2005: upgrade of software in the regulatory testing laboratory;
- April 2005: four new products (anti-rabies and anti-tetanus immunoglobulins, as well as anti-botulism and anti-diphtheria anti-serums) have been added to the list of stable products supplied to hospitals;
- Summer 2005: introduction of the Rendez-vous information system to improve the management of appointments for donors of platelets by apheresis;
- 2006: preparation of a contingency plan in the case of an influenza pandemic.
Standardized manufacturing procedures
We translate all of the national standards issued by Health Canada into standard operating procedures (SOP), which are written procedures that must be followed by all employees when carrying out product collection, analysis, preparation and delivery operations. Our orgazination has more than 460 SOP that govern its activities.
Quality control and training
We have implemented a rigorous quality control and assurance system to ensure product quality and respect for standards.
Staff members we hire are provided with complete training that leads to internal certification. We have also implemented a professional development program. All of this is done with a view to ensuring the safety of the blood supply to hospital centres and their patients.
In order to ensure a safe blood supply for Quebecers, we perform internal audits of operations at each of our facilities (Montréal and Québec City), periodic inspections of critical material and stable product suppliers, and evaluation of potential suppliers as to their ability to respect good manufacturing practices for the work requested.
These inspections are integral to our continuous improvement process, which enables the employees and managers concerned to perform the corrective measures required to maintain the highest level of compliance with standards.