Laboratory Management, Quality Assurance and Ethics
Laboratory Management, Quality Assurance and Ethics tests how a laboratory produces reliable results and behaves responsibly. Expect quality control, quality assurance, accreditation, audits, proficiency testing, error investigation and ethical duties.
Core rules
- Quality control monitors each analytical run; quality assurance covers the whole pathway from ordering to reporting.
- Levey-Jennings charts detect shifts and trends. Westgard rules include 1-3s for rejection, 2-2s for systematic error and R-4s for random error.
- Proficiency testing compares results with peer laboratories and is required for accreditation.
- Corrective action follows root-cause analysis, not blame. Documentation closes the loop.
- Standard operating procedures must be current, accessible and version-controlled.
- Ethics includes consent, confidentiality, competence, conflict-of-interest disclosure and honest reporting.
Worked example
A chemistry analyzer shows a control result above the 3 SD limit on one level, while other levels are acceptable. Using the 1-3s rule, the run is rejected. Reasoning: a single result outside 3 SD is unlikely by chance and may indicate random or systematic error. The laboratory should repeat the control, check reagents and calibration, document the investigation and release patient results only after acceptable performance.
Traps
Do not confuse QC with QA. A passing proficiency test does not guarantee daily quality. Do not release results on a rejected run because the patient is urgent without a documented risk assessment. Avoid identifying patients in audits or teaching. Do not hide a corrected error.