The Blood Bank and Transfusion Services Standards apply to organizations with blood banks and transfusion services and are to be used in conjunction with the Laboratory and Blood Services Standards.
The Blood Bank and Transfusion Services standards are based on the Canadian Standards Association (CSA) Standard Z902-04. These standards also meet the recommendations from the Comité consultatif nationale de médicine transfusionnelle (CCNMT) in Quebec.
Given that CSA Standard Z902-04 for Blood Banks & Transfusion Services covers whole blood and blood products, and given that stable blood products play an important role in transfusion medicine, the elements of CSA Z902-04 included in this list of requirements and dealing with the storage, processing, transport, use and traceability of blood products must apply to stable products and be included in the accreditation process of laboratories, blood banks and transfusion services.
The organization’s compliance with the elements included below will be evaluated in line with applicable laws and regulations, the recommendations of the CCNMT (Comité consultatif national de médecine transfusionnel) and requirements of different manufacturers, specifically those concerning the traceability of blood products and specific storage temperatures.
This standard section covers the following subsections:
Accurately screening and selecting donors (CSA Z902-04 clause 5) including the risks associated with walking (clause 15), directed and dedicated donors (clause 14);
Collecting blood in a safe and timely way (CSA Z902-04 clause 6) including specific precautions for autologous donation and perioperative blood collection (Z902-04 clause 12);
Preparing and storing appropriate, stable, and sterile blood components (CSA Z902-04 clause 7) including detailed requirements for whole blood, red blood cells (RBCs), plasma, platelets, and granulocytes;
Accurately testing and labelling whole blood and blood components (CSA Z902-04 clauses 7 and 8) including specific requirements to label and identify autologous (clause 12), directed and dedicated donations (clause 14);
Safely releasing, packing, storing, and transporting blood and blood components (CSA Z902-04 clause 9) including appropriate notification and recall procedures for unsafe components (clause 18);
Providing safe and timely transfusion services (CSA Z902-04 clauses 10 and 11) including additional requirements for home transfusion (clause 16), and processes to handle adverse events (clause 17). This standard section is not intended to address those activities routinely performed by Héma-Québec or Canadian Blood Services (CBS), i.e. donor selection and the collection of blood for allogeneic donations or collection, collecting blood by apheresis.