Blood and blood components

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, efficacy, and quality for recipients, safety of donors, management of blood and blood components, and safety of 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, this Standard outlines specific requirements to be included in the facility's operating procedures for the following activities:
 

• (a) donor selection for allogeneic blood collection;
  (b) collection of blood and blood components for transfusion;
  (c) preparation of blood components;
  (d) testing and labelling of blood and blood components;
  (e) release, storage, packing, and transportation;
  (f) requests, pre-transfusion testing, selection of components, and acceptance criteria;
  (g) transfusion;
  (h) autologous blood collection and transfusion; 
  (i) apheresis donation;
  (j) transfusion service responsibilities regarding blood products used in the facility;
  (k) directed donations and designated donations;
  (l) walking donor programs;
  (m) home transfusion;
  (n) adverse event monitoring and corrective action;
  (o) removal of unsafe components and donors from the blood supply;
  (p) record management; and 
  (q) validation and maintenance of computer systems.

1.4
This Standard does not include requirements for activities associated with
 

• (a) the collection of source plasma; and
  (b) the processing, manufacture, or commercial distribution of plasma derivatives and related blood products, including solvent detergent plasma.

Note: Source plasma is covered under the Food and Drug Regulations for human plasma collected by plasmapheresis (i.e., Sections C.04.400 through C.04.423, 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.
    Annexes are designated normative (mandatory) or informative (non-mandatory) to define their application.