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

Traceability

Quality Audit Preparation

Process:

Traceability

Area:

Clinical areas

Laboratory processes

Auditees:

Any person involved in the process this may include:

  • Blood Bank staff BMS or MLA
  • On Call staff
  • All staff involved in the administration of blood/blood components

Initial preparation:

  • SOP for the Laboratory process of printing / issuing the documentation for traceability is it:
    • Specific
    • In date
    • Appropriately signed/authorised by an authorised signatory
    • Complete equipment list
    • Official copy
    • Links to COSHH / Risk assessments
    • Regularly reviewed
  • Current traceability figures
  • If units are transferred/wasted etc how are these entered into LIMS
  • Identify where there may be problems i.e. duplication of paperwork

Additional Evidence required:

  1. Validation of system
  2. Training records and competency assessments/competency of trainers
  3. Document control
  4. Follow up of “non returns”
  5. How returns entered into LIMS either manual or automated
  6. Incident forms for non compliances

Interviews/process:

  1. Observation
  2. Questions
  3. Knowledge assessment
  4. Objective evidence

Additional requirements:

  1. Where a paper trail for traceability is in operation
    • How are non returns identified and by who
    • How are the non returns followed up
    • What is the time scale for investigation of non returns
  2. Where an electronic system for traceability is in place
    • How are non returns identified and by who
    • How are the non returns followed up
    • What is the time scale for investigation of non returns
  3. Both systems
    • Feedback to clinical areas
    • If traceability is not 100% how is this to be addressed in the future
    • controls are in place to ensure that inappropriate follow up does not occur eg letters sent to clinical areas when label already returned but missed!
    • How trends are identified dealt with