Laboratory Administration and Operations
Regulatory framework
CLIA categorizes tests as waived, moderate, or high complexity and sets personnel, QC, and proficiency testing requirements. Laboratories are surveyed by CMS or a deemed authority (CAP, TJC). Test method validation before reporting must address accuracy, precision, analytical measurement range, limit of detection, interference, and reference interval verification.
Quality control statistics
Levey-Jennings charts plot QC values against ±1, ±2, and ±3 SD. Westgard rules: 1-2s is a warning only; 1-3s, 2-2s, R-4s, 4-1s, and 10x reject the run. Shift (values on one side of the mean) and trend (progressive drift) require investigation even when single points pass. Calibration is not the same as calibration verification; a delta check compares a result against the patient's previous value.
Operations and safety
Understand full-time equivalents and productivity (tests per FTE), cost per reportable test, and break-even analysis. Process improvement uses PDCA, root cause analysis, and failure mode analysis. OSHA governs bloodborne pathogens and chemical hygiene; the SDS must be accessible; fire safety follows PASS and RACE.
Traps
Questions often reward the conservative option: when a QC rule fails, do not report patient results. Proficiency testing specimens must be handled exactly like patient samples - never shared between laboratories.
Worked example: a single QC value falls outside ±2 SD but inside ±3 SD. This triggers the 1-2s warning rule, so inspect the chart for a second point; if none and the next value is within limits, the run may continue, but the event is documented. A subsequent 1-3s or 2-2s failure mandates rejection and corrective action.