Quality Audit Preparation
Emergency Group and Issue
Blood Bank Laboratory
Any Staff involved :
- MLA staff
- BMS staff
- BMS trainees
- See 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:
- Staff training records
- Competency records
- Quality Control records (for manual process)
- Reagent/process logs and validation records.
- Maintenance and service records.
- Record observations of audit process on form F10 Examination Audit
- Observe process by staff member(s) for adherence to SOP.
- Interview staff for both knowledge and understanding including;
- Importance of sample identification(criteria for emergency case sample &/or unknown ID of admission patient)
- 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.
- Process to be followed if units subsequently shown to be incompatible by full group/Ab/Xmatch procedure.
- issue of Emergency O Negs policy and process.
- Traceability aspects of issue including BARS.
- Cold chain/GMP understanding.
- Check training records. i.e. is person(s) performing process trained.
- Check competency records.
- Check QC records.
- Check equipment maintenance records. i.e. cleaning, spin speeds, temperatures, calibration data, validation data.
- Check reagents being used for validation checks, expiry dates, storage
- Reporting/data entry SOP.
- Record information of Audit on Form F 10 (obtain from QM).
- Review findings with QM. QM to set course of action plan to deal with section head/Head for non compliances.