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

Incident reporting - Reporting of Incidents that occur anywhere in the Transfusion chain to SABRE/Datix

Quality Audit Preparation

Process:

Reporting of Incidents that occur anywhere in the Transfusion chain to SABRE/Datix

Area:

Trust-wide and any Legal Entities that have a SLA

With the trust for supply of blood/components

Auditees:

Any person involved in the process including-:

  • Hospital Transfusion Team
  • Blood-bank staff
  • Nursing Staff
  • Medical Staff

Initial preparation:

Is the SOP for incident reporting to SABRE-:

  • Specific
  • In date and Document controlled
  • App signed/authorised and Official
  • Trained staff sign off sheet
  • Appendices for MHRA SAR/SAE reporting
  • Regularly Reviewed

Additional Evidence required:

  1. Regular review of incidents at HTT level
  2. Regular reporting of appropriate incidents to SABRE
  3. Where is the Blood bank SOP for investigation of Suspected transfusion reactions
  4. File of Worksheets from past investigations
  5. Where are the Competency assessments of staff doing investigation and their trainers
  6. Evidence of Root Cause Analysis training

Interviews/process:

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

Additional requirements:

  1. Local recording system of reported incidents
  2. Reporting of incidents to Risk Management
  3. Clinical Staff awareness of process for reporting of suspected transfusion reactions/incidents
  4. Risk managers input into review of SABRE reportable incidents and action plans in place at Clinical Governance & Board level