Laboratory Management
Core concepts
Laboratory management questions test the intersection of quality, finance, staffing and regulation. Understand the quality management system: document control, competency assessment, equipment qualification (installation, operational and performance qualification), method validation and verification, and the corrective and preventive action cycle. Know the difference between accreditation, certification and licensure, and the roles of external quality assessment and internal quality control.
Financial literacy matters: cost per test, fixed versus variable costs, break-even analysis, and the rationale for test utilisation review. Human resource topics include competency assessment frequency, continuing education, and the distinction between credentialing and privileging. Understand turnaround time as a key performance indicator and the laboratory's role in clinical governance. Risk management requires incident reporting, root cause analysis, and failure mode and effects analysis.
Traps in questions
Do not confuse internal quality control (daily, within-run) with external quality assessment (periodic, inter-laboratory). Method validation applies to new in-house methods; verification applies to methods already validated by the manufacturer. A corrective action addresses a detected problem; a preventive action addresses potential problems. Break-even analysis requires separating fixed from variable costs.
Worked example
A test has a fixed cost of 100,000 units per year and a variable cost of 5 units per test, with a reimbursement of 15 units per test. Break-even volume = fixed cost / (price − variable cost) = 100,000 / 10 = 10,000 tests per year. Any volume above this yields contribution to profit.
Rule of thumb
For any management scenario, identify the quality system element involved before choosing an intervention.