Quality standards to be met by blood banks

SUMMARY OF:

Directive 2005/62/EC on standards and specifications relating to a quality system for blood establishments

WHAT IS THE AIM OF THE DIRECTIVE?

It sets out how national authorities should comply with various requirements to ensure the safety and quality of human blood collected and tested in the EU.

KEY POINTS

EU countries must ensure the following.
- All blood establishments comply with the EU’s safety and quality standards and specifications.
- Good practice guidelines are available and used by all blood banks. They must take into account the good practice guidelines jointly elaborated by the European Commission and the European Directorate for the Quality of Medicines & Healthcare of the Council of Europe. According to Directive (EU) 2016/1214, EU countries should ensure that blood establishments comply with the good practice guidelines for their quality systems by 15 February 2018.
- Quality controls apply to blood and blood components from non-EU/non- European Economic Area countries before they are imported into the EU.
The management of blood establishments must systematically implement and maintain a quality system.
The quality system covers:
- quality assurance — validation of all procedures, premises and equipment;
- personnel and organisation — staff must have proper training, clear tasks and responsibilities and exist in sufficient numbers;
- premises — these must have specified areas for confidential interviews and the collection, testing, processing and storage of blood and waste disposal;
- equipment and materials — these must be validated, calibrated, maintained and recorded in an inventory;
- documentation — specifications, procedures and records of every activity must be kept up to date;
- blood collection — procedures to identify, interview and assess donors must be in place and the risk of microbial contamination minimised;
- laboratory testing — all procedures must be validated before use and their quality regularly assessed;
- processing and validation — all equipment and technical devices must be used according to validated procedures;
- labelling — all containers should be labelled with relevant information about the identity of their contents at all stages;
- release — no single blood or blood component may be released until all mandatory requirements in the legislation have been complied with;
- storage and distribution — procedures must be in place to avoid any mix-ups of blood components;
- complaints — these must be documented and carefully investigated. Where necessary, this may involve the recall of products and implementation of corrective measures to prevent their recurrence;
- recall — an effective recall procedure must be in place, allowing for relevant blood (components) to be traced;
- self-inspections — these or audit systems should be in place for every operation to verify compliance with the legislation.

FROM WHEN DOES THE DIRECTIVE APPLY?

It has applied since 21 October 2005. EU countries had to incorporate it into their national law by 31 August 2006.

BACKGROUND

Directive 2005/62/EC sets out the technical requirements which ensure that the quality and safety standards laid down in Directive 2002/98/EC are respected.
For more information, see:
- ‘Blood, tissues and organs’ (European Commission).

MAIN DOCUMENT

Commission Directive 2005/62/EC of 30 September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards Community standards and specifications relating to a quality system for blood establishments (OJ L 256, 1.10.2005, pp. 41-48)

Successive amendments to Directive 2005/62/EC have been incorporated into the original document. This consolidated version is of documentary value only.