Laboratory Management, Quality Assurance, and Regulatory Compliance
Core Concepts
Laboratory management covers quality control, quality assurance, proficiency testing, and regulatory compliance (CLIA, CAP). Know the difference between internal quality control (daily controls, calibration) and external quality assessment (proficiency testing). Understand document control, competency assessment, turnaround time monitoring, and specimen tracking. Recognize the requirements for validation of new tests and for reporting critical results.
Common Traps
- Confusing quality control (daily, internal) with quality assurance (system-wide, process improvement).
- Missing proficiency testing failures and the required corrective action.
- Overlooking document control requirements for SOPs and version history.
- Forgetting that competency assessment must be documented for all testing personnel.
Rule of Thumb
When a question asks about a failed control, the first step is to stop reporting patient results, investigate, and document corrective action. A worked example: an IHC run shows a negative control with unexpected staining - reject the run, troubleshoot antibody or retrieval, repeat with fresh controls, and document the event in the QA log.
Compliance Pearl
Maintain records for the required retention period and ensure SOPs are reviewed and signed at defined intervals.