Laboratory Management and Informatics
Core concepts
This domain covers the operational and regulatory side of the laboratory. Know quality management systems: quality control (Levey-Jennings charts, Westgard rules), proficiency testing, and the difference between accuracy and precision. Understand regulatory frameworks (CLIA, CAP accreditation) and test categorization (waived, moderate, high complexity). Know the laboratory's role in patient safety: critical value reporting, specimen labeling requirements, and delta checks. Master informatics basics: LIS/LIMS functions, HL7 interfaces, barcoding, and the distinction between validation and verification. Understand turnaround time metrics, staffing, and cost analysis concepts.
Traps
Examiners test Westgard rule interpretation: 1-3s is a warning, 2-2s and R-4s indicate random error, while 4-1s and 10x indicate systematic error. Another trap is confusing verification (confirming performance in the local setting) with validation (establishing performance for a new assay). Questions may ask about critical value documentation-verbal reporting must be read back and documented. Do not assume a waived test is exempt from quality oversight entirely.
Worked example / rule of thumb
When a QC point exceeds 3 SD (1-3s), do not automatically reject the run; investigate. If two consecutive points exceed 2 SD on the same side (2-2s), reject and troubleshoot systematic error. Rule of thumb: random error shows scatter; systematic error shows shift or trend.