Laboratory Administration: Quality, Compliance, and Operations
Core concepts
Know the quality management system elements: quality control (daily performance monitoring), quality assurance (processes ensuring quality), and quality improvement (PDCA/Plan-Do-Check-Act). Understand the difference between internal QC (daily controls, Westgard rules) and external proficiency testing (EQA) required for accreditation. Know the regulatory framework broadly: CLIA categories (waived, moderate, high complexity) and the role of accrediting bodies.
Personnel and safety
Understand personnel competency assessment requirements and documentation. Know the hierarchy of safety controls (engineering > administrative > PPE) and standard precautions. Understand the concept of sentinel events, root cause analysis, and corrective/preventive action (CAPA). Know basic budgeting and inventory concepts (reagent lot management, turnaround time, staffing).
Traps
Questions test the difference between QC and QA, and between proficiency testing and internal QC. Beware assuming a waived test requires the same oversight as high-complexity testing. Another trap: confusing root cause analysis (retrospective, system-focused) with corrective action (fixing the specific problem).
Worked example
A lab has repeated QC failures on one analyzer. The corrective action is not to simply rerun; it is to investigate root cause (calibration drift, reagent lot, maintenance) and document CAPA. Rule of thumb: QC detects; QA prevents; QI improves.