JPAC Joint United Kingdom (UK) Blood Transfusion and Tissue Transplantation Services Professional Advisory Committee

Documentation Issues

Clarification January 2009

How long would you expect to see laboratory documents (e.g. cleaning logs) kept for?

There would seem to be no reason to keep routine ‘housekeeping’ logs for the same period of time as other documents/worksheets. It is expected that at least two (full) year’s records should be maintained at all times, for trending and inspection purposes, in their original format. It is suggested that at the end of each year, or other period as determined by the laboratory, a summary sheet be prepared for applicable records, which would include:

  • Period of time covered
  • Clear description / identification of the logs destroyed
  • Disposal date
  • A statement regarding whether the logs were completed appropriately, e.g.
    • Identify the % of completed logs
    • Identify what actions may be required to rectify gaps or deficiencies in recording.

A documented rationale should be available for the retention period applied to documents which may be archived or destroyed on a periodic basis. It is recommended that any records which may be periodically destroyed or archived are specifically listed, to ensure that the default position is full retention of records. This will protect against records being removed in error.

Critical records, such as temperature charts for blood component storage equipment, superseded SOPs and incident investigations should not be destroyed in the same manner as housekeeping records. Consideration may be given to electronic archiving of these records, provided that the archived data is secure and has been shown to be retrievable.

Records which are linked to an unclosed investigation should not be destroyed or archived. Records associated with the investigation of a SABRE report should be retained with the SABRE report for the Statutory 15 years.

Other records, such as equipment maintenance and calibration, should be kept in full for the life of the equipment, in order to build an ‘equipment history’ log.

Staff training logs may be archived (not destroyed) when a member of staff leaves the employment of the laboratory, however these should be kept ‘inspection ready’ for at least one year after their departure.

How often should SOP’s be reviewed?

If an SOP has been in place for considerable time and has required no alteration/amendment over the recent years it would be reasonable to set a review date of 2 years. Each review should be documented, either on the SOP master, or in a separate log/record.

If an SOP is substantially changed, or newly written, then more frequent review (e.g. annual) may be appropriate until such time the SOP is “stable”.

Critical SOPs are likely to be reviewed annually when staff competencies are undertaken and this would be the case for “critical” SOP’s i.e. recall, incident reporting, ABO and D grouping and crossmatching and any other deemed by the laboratory as covering a critical function.