scope:

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.

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.

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.