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

Screening - manual

Quality Audit Preparation

Process:

Blood Grouping and Antibody Screen – Manual

Area:

Blood Bank Laboratory

Auditees:

Any Staff involved :

  • MLA staff
  • BMS staff
  • BMS trainees

Initial preparation:

  • SOP for Audit protocol.
  • Obtain Audit report form from Quality Manager
  • Locate SOP for process
  • Locate any associated cross referenced SOP’s, COSHH, Risk Assessments, Policy/Guidelines e.g. Sample reception, Sample rejection, Handling urgent work, Error logging.
  • Inspect and assess SOP against standard SOP template for completeness of information/instructions.

Additional Evidence required:

  1. Staff training records
  2. Competency records
  3. Quality Control records (for manual process)
  4. Reagent/process logs and validation records.
  5. Maintenance and service records.

Interviews/process:

  1. Record observations of audit process on form F10 Examination Audit
  2. Observe process by staff member(s) for adherence to SOP.
  3. Interview staff for both knowledge and understanding including:
    • Importance of sample identification
    • Historical patient records and dealing with discrepancies
    • Check grouping if 1st sample
    • Result entry into Host system
    • QC requirements of process
    • Post testing, Pre-authorisation sample/patient identity check.
    • Understanding of consequences of manual methodology/transcription errors.
  4. Check training records. i.e. is person(s) performing process trained.
  5. Check competency records.
  6. Check QC records.
  7. Check equipment maintenance records. i.e. cleaning, spin speeds, temperatures, calibration data, validation data.
  8. Check reagents being used for validation checks, expiry dates, storage
  9. Reporting/data entry SOP

Additional requirements:

  1. Record information of Audit on Form F 10 (obtain from QM).
  2. Review findings with QM. QM to set course of action plan to deal with section head/Head for non compliances.