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: http://www.legislation.gov.uk/uksi/2005/50/made