Safety measures and quality assurance
The safety of donations of biological products of human origin – such as blood, plasma, platelets, mother’s milk, stem cells and human tissues – is critical in protecting both those who give and those who receive these donations.
Héma-Québec makes every effort to provide the people of Québec with safe, top-quality products. Here are the key measures put in place to ensure this safety:
Rigorous selection process for donors
Strict eligibility criteria
Individuals who donate are subject to eligibility criteria based on their health status, medical history and behaviors to minimize the risk of disease transmission.
Donor qualification questionnaires
Donor questionnaires are used to gather information to determine if you meet the eligibility criteria.
Donor selection interview
An interview with Héma-Québec staff is conducted to ensure that the donation will be safe for both the donor and the recipient.
Infectious disease screening
Systematic testing
Each donation is systematically tested for communicable infections such as HIV, hepatitis B and C, and other potential pathogens.
Additional tests
In some cases, additional testing may be required depending on the history of the donor or the nature of the donation.
Traceability of donations
Rigorous traceability
Each donation is carefully tracked and documented from donor registration to the end use of the product to ensure traceability and the ability to go back to the source if necessary.
Destruction of non-compliant products
Non-compliant products
If an infection or contamination is detected, the product is destroyed to avoid the risk of transmission.
Preservation and transportation
Adapted preservation conditions
Biological products are preserved under specific conditions (temperature, preservation medium) to maintain their integrity.
Secure transportation
Strict packaging protocols are in place during transportation, ensuring that products are not exposed to conditions that could compromise their quality.
Standards and regulatory requirements
Regulations
Héma-Québec complies with rigorous quality and safety standards and holds licences and certifications from various regulatory agencies that conduct periodic inspections and audits.
Periodic inspections and audits
Regular inspections and audits are carried out to verify that practices are compliant with safety standards.
Major changes to operations
For example, in order for Health Canada, the body responsible for the regulation of transfusion systems in Canada, to accept a request for a change in the selection criteria, Héma-Québec must provide it with an extensive submission, including evidence that these changes will not compromise the safety of blood products. The evolution of epidemiological knowledge and scientific evidence must support these changes.
Regular on-the-job periodic training
Regular periodic training for optimal quality and safety
Héma-Québec staff involved in the collection, handling and distribution of biological products receive ongoing training on all the tasks associated with the various processes in order to remain on the cutting edge and ensure donor safety and optimal product quality.