Laboratory Operations and Management
What to master
Know the regulatory frame: CLIA certificate types and test complexity categories (waived, moderate, high), personnel qualification requirements, and accreditation by CAP or The Joint Commission. Distinguish method verification (FDA-cleared method adopted by the laboratory) from validation (laboratory-developed or modified method). Quality control: control materials, Levey-Jennings charts, and Westgard multirules (1-2s warning, 1-3s rejection, 2-2s, R-4s, 4-1s, 10x), plus moving averages and delta checks. Proficiency testing must be handled as patient samples with no interlaboratory communication. Calibration, lot-to-lot verification, document control, change control, and competency assessment (six required elements, semiannual in the first year, annual thereafter).
Operational topics include LIS and autoverification rules, critical value reporting with read-back, specimen rejection criteria, reference interval establishment, turnaround time monitoring, quality indicators, root cause analysis, FMEA, and Lean process improvement. Safety covers OSHA bloodborne pathogens and chemical hygiene standards, PPE, waste handling, and select agent rules.
Traps
A 1-2s rule is a warning, not a rejection. Confusing delta check with QC and misstating competency frequency are common distractors; so is assuming waived testing requires no oversight.
Worked example
A control result falls 3.4 standard deviations from the mean on one level. The 1-3s rule is violated, so the run is rejected before patient results are reported; investigate the cause and repeat before releasing results.