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

Report validation

Quality Audit Preparation

Process:

Report Validation to include Blood Bank IT system

Area:

Blood Transfusion Laboratory

Blood Transfusion Care Pathway

Auditees:

  • Blood Bank Staff (BMS or BSW under supervision)
  • Transfusion Practitione

Initial preparation:

SOP review - is it:

  • Readily located?
  • In correct Trust format?
  • In date?
  • Fully signed/approved?
  • Master or Copy?
  • Is there evidence of regular review?
  • Is the document complete with all appendicies?
  • Is a risk assessment attached?
  • Has the document been equality assessed?
  • Document control - If copies have been issued, can they be traced?
  • Are any copies correct/current?

Additional Evidence required:

  1. Evidence of training & awareness?
  2. Patient request form.
  3. Printed report corresponding to above request.
  4. Printout of Aucom routines appropriate to selected report.
  5. Barcode numbers of any products issued in association with the selected report.
  6. Evidence of change control over the reporting process?

Interviews/process:

  1. Staff awareness of process
  2. Is IT security sufficient to prevent untrained or unauthorised staff authorising results or amending reports?
  3. Are the set up procedures for report routines e.g. Aucom or MREP only accessible by authorised staff?
  4. Do staff log in to IT system using own user name/password?
  5. Is request form available?
  6. Do all patient demographics between request form and IT system correspond?
  7. If authorisation of results generates extra tests via an Aucom routine has the test/correct test been generated?
  8. If authorisation of results generates comments via an Aucom routine has the appropriate comment been generated?
  9. Is a report printed?
  10. Is there a record that a report has been printed?
  11. Do recorded results on computer correspond to those printed on the report?
  12. Is the report legible/understandable?
  13. Are the reports checked for correctness before issue?
  14. Has the member of staff logged off from the IT system?

Additional requirements:

  1. If a report is incorrectly printed/badly printed is there an SOP which tells staff what to do, who to speak to
  2. Have the staff been trained, correctly documented, for changing printer cartridges etc.