CAN/CSA-Z902-04 (R2009)

1 Scope 1.1 This Standard provides management requirements for facilities that collect, process, store, and use human blood and blood components for transfusion. It addresses issues of safety and efficacy for recipients, and safety for facility personnel and others who are exposed to or potentially affected by blood and blood components. 1.2 This Standard applies to blood centres and transfusion services and to any other organization that collects, processes, stores, or uses human blood or blood components for transfusion. 1.3 As a management standard, this Standard is not intended to replace detailed specifications and operating procedures; rather, it is intended for use in their preparation. It includes requirements for policies and procedures, quality management, personnel, physical plant, and equipment. In addition, the Standard outlines specific requirements to be included in the facility's operating procedures for the following activities: (a) donor selection; (b) collection of blood and blood components; (c) preparation, testing, and labelling; (d) storage, packing, and transportation; (e) acceptance criteria, pre-transfusion testing, and selection of components; (f) transfusion; (g) autologous blood collection and transfusion; (h) apheresis; (i) designated donations and directed donations; (j) walking donor programs; (k) home transfusion; (l) adverse event monitoring and corrective action; (m) record management; and (n) validation and maintenance of computer systems. This Standard also provides requirements for the administration of Rh immune globulin. Note: Although Rh immune globulin is considered to be a blood product rather than a blood component, requirements for administration are included in this Standard because of the product's prevalence and importance in the treatment of Rh-negative pregnant women, and the need for serological testing of recipients. 1.4 This Standard does not include requirements for activities associated with (a) the collection of source plasma; and (b) the processing, manufacture, or distribution of plasma derivatives and related blood products, including solvent detergent plasma. Note: These activities are covered under the Food and Drug Regulations for human plasma collected by plasmapheresis (i.e., Sections C.04.400 through C.04.428, Division 4, Part C). 1.5 In CSA Standards, "shall" is used to express a requirement, i.e., a provision that the user is obliged to satisfy in order to comply with the Standard; "should" is used to express a recommendation or that which is advised but not required; and "may" is used to express an option or that which is permissible within the limits of the Standard. Notes accompanying clauses do not include requirements or alternative requirements; the purpose of a note accompanying a clause is to separate from the text explanatory or informative material. Notes to tables and figures are considered part of the table or figure and may be written as requirements. Legends to equations and figures are considered requirements.