Laboratory Management
Domain focus
Laboratory management questions test quality management systems, ISO 15189 principles, document control, personnel competence, equipment and inventory management, POCT oversight and corrective action in resource-limited Cambodian laboratories.
Core rules
- Every procedure must be a controlled document with version, approval date and review date.
- Staff must be trained, competency-assessed and authorised before independent testing.
- Equipment requires installation qualification, calibration, maintenance and downtime records.
- Reagents and consumables need lot tracking, expiry control and stock rotation.
- Corrective action addresses root cause; preventive action addresses potential failure.
- POCT devices outside the main laboratory remain under laboratory quality oversight.
Worked example
A creatinine assay fails QC on three consecutive days after a reagent lot change. The supervisor reviews lot validation, calibration and water quality. The root cause is failure to calibrate the new lot. Corrective action: recalibrate, repeat QC, quarantine the affected patient results and review them. Effectiveness is confirmed by seven days of acceptable QC. This is corrective, not preventive, because the failure already occurred.
Traps
- Confusing corrective action with preventive action.
- Using uncontrolled SOPs downloaded from the internet.
- Letting expired reagents remain in use because 'QC looked fine'.
- Excluding ward glucose meters from laboratory oversight.