Blood Safety and Quality Regulations 2005

The Regulations implement the provisions of Directive 2002/98/EC and associated Directives so that the retention periods for data relating to human blood and blood components outlined in the Directive are now part of UK law. Blood establishments and hospital blood banks must retain data needed for full traceability for at least 30 years from the point of receipt of the blood or blood component (regulations 8 and 9).

The data that should be retained for 30 years in order to comply with the traceability requirements is as follows.

Data to be retained by facilities:

  • blood component supplier identification
  • issued blood component identification
  • transfused recipient identification
  • for blood units not transfused, confirmation of subsequent disposal
  • date of transfusion or disposal (year/month/day)
  • lot number of the component, if relevant

Blood establishments and hospital blood banks must retain a record of any serious adverse events which may affect the quality or safety of blood and blood components for a minimum of 15 years (regulations 7 and 9). The Regulations also set out requirements for maintaining the confidentiality and security of data (regulation 14) and provide that identifiable information held by blood establishments and blood banks must not be disclosed to third parties unless it is for one of the following reasons:

  • to comply with a court order
  • to assist an inspector appointed by the Secretary of State in accordance with the Regulations
  • to enable tracing of a donation from donor to recipient or from recipient to donor
  • Blood Safety and Quality Regulations 2005 (as amended)

Records management considerations

Organisations must ensure that they are able to provide full traceability of whole blood and blood components.

There should be a record keeping system that:

  • allows for identification of each single blood donation and each single blood unit and components thereof
  • enables full traceability to the donor as well as to the transfusion and the recipient
  • That is, the method of recording must unmistakably identify each unique donation and type of blood component, the location at which the donation was received and to whom that donation was given

For more information:

SHOT (Serious Hazards of Transfusion) - Electronic Clinical Transfusion Management System

Supporting the automated tracking of blood products

Following a blood safety stakeholder workshop, four initiatives to improve blood safety were selected for further testing and development. One of these initiatives was the use of barcode technology to help prevent final identity checks carried out at the patient’s side (at the bedside) from failing.

This national specification, which is part of the NPSA’s blood safety initiative,
Right patient, right blood, has been developed with the following objectives:

• to address the patient safety risks in the transfusion process;
• to identify IT requirements for a blood tracking system;
• to provide an initial specification for IT suppliers.

This specification for an Electronic Clinical Transfusion Management System
(ECTMS) focuses on the steps in the transfusion pathway taking place outside the laboratory and is relevant to both barcoding and Radio Frequency Identification (RFID) technology.

For more information: DOWNLOAD

Also for your reference:

MSoft Blood360 Blood Tracking System provides restricted access to blood component storage devices and contains a full audit trail of the blood components movements and administration, in accordance with:

Statutory Instruments 2005/50, 2005/1098  and 2006/2013: Link

EU Directive 2002/98/EC: setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC Link

EU Directive 2004/33/EC: implementing Directive 2002/98/EC of the European Parliament and of the Council as regards certain technical requirements for blood and blood components Link

EU Directive 2005/61/EC: implementing Directive 2002/98/EC of the European Parliament and of the Council as regards traceability requirements and notification of serious adverse reactions and events Link

EU Directive 2005/62/EC: 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 Link