Laboratory Quality Management and Quality Control
Laboratory Quality Management and Quality Control tests the candidate's ability to run a defensible quality system: documents, controls, proficiency testing, corrective action, and error prevention. The exam focuses on whether results are fit for clinical use, not only whether an instrument is running.
Core rules
- Use a quality system approach: standard operating procedures, training records, equipment logs, document control, and complaint review.
- Run quality control before patient samples, chart controls on Levey-Jennings plots, and apply Westgard rules such as 1-3s and 2-2s for rejection.
- Calibrate when required, verify calibration, enroll in external quality assessment, and investigate proficiency failures.
- Use root-cause analysis and corrective and preventive action; record the problem, cause, action, and effectiveness check.
- Validate new methods or instruments before reporting patient results.
Worked example
A glucose control is plus 3 SD. The 1-3s rule rejects the run. The reasoning: do not report patient glucose; repeat the control, check reagent and calibration, and document the investigation. If repeat passes, verify the corrective action; if not, escalate. Calibrating blindly without identifying the cause is not acceptable.
Traps
Running controls after patients, ignoring trends within 2 SD, using expired controls, and treating a proficiency test failure as a paperwork issue. Also avoid corrective action that stops at retraining without checking system causes.