Draft Details

1.1 Management requirements for facilities collecting, processing, storing, and using human blood components for transfusion

This Standard provides management requirements for facilities that collect, process, store, and use human blood components for transfusion. It addresses issues of safety, efficacy, and quality for recipients, safety of donors, management of blood components, and safety of facility personnel and others who are exposed to or potentially affected by blood components.

1.2 Scope

This Standard applies to blood centres, transfusion services, and to any other organization that collects, processes, stores, or uses human blood components for transfusion.

1.3 Requirements for storage and use of blood products

It also includes requirements for the storage and use of blood products, when such products are within the responsibility of an organization that is covered by this Standard.

Note: While this Standard does not specifically apply to organizations that manage blood products but not blood components (e.g., a hospital pharmacy), these organizations are encouraged to review the relevant requirements for blood products and incorporate them as appropriate into their procedures.

1.4 Activities within the scope of the Standard

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 components for transfusion;

c) preparation of blood components;

d) testing and labelling of 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;

Note: This Item refers to blood products that are managed directly through the transfusion service, as opposed to those managed by other services, e.g., the pharmacy.

k) directed donations and designated donations;

l) pre-assessed 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.

1.5 Exclusions

This Standard does not include requirements for activities associated with

a) the collection of plasma for use in the manufacture of plasma products; and

b) the processing, manufacture, or commercial distribution of blood products, including solvent detergent plasma.

Note: Plasma for use in the manufacture of a drug for human use is covered under the Blood Regulations.

1.6 Use of shall, should, and may

In this Standard, “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.