It has long been recognised that blood bank institutions
have an obligation to not only provide a safe product for
patients, but also to protect the health and welfare of their
donors and their staff.
Donor and product safety has improved significantly
over the last decade as a consequence of the introduction of
measures such as evidence-based blood donor selection criteria,
which take into account the precautionary principle
where appropriate and improved screening of blood donations
for infectious agents. However, the implementation of
underpinning quality assurance programmes based on
good manufacturing practice has also played a key role in
improving safety and quality of blood and blood components.
The main objective of a quality assurance programme
within the blood bank setting is to minimise risk to safety
and quality by ensuring that the blood bank’s processes will
reliably deliver safe, efficacious blood and blood components
that are collected and manufactured in a manner that
causes no harm to donors or to staff.
In many countries, implementation of a quality assurance
programme has become a regulatory or government
requirement; however, an effective programme not only
forms the basis for safety, but can also deliver benefits to
the Blood Service beyond meeting compliance.