Laboratory Quality Management and Regulatory Compliance
Core concepts
Know the quality framework: CLIA (US clinical laboratory certification), CAP accreditation, ISO 15189, and applicable regulations such as HIPAA and GINA. Understand quality control (QC) vs quality assurance (QA), proficiency testing (PT), validation vs verification, analytic validity, clinical validity, and clinical utility.
Be familiar with turnaround time, specimen handling, chain of custody, document control, corrective and preventive action (CAPA), root cause analysis, and incident reporting. Understand LDT vs FDA-cleared/approved tests and the regulatory landscape for laboratory-developed tests. Know requirements for report content, result interpretation, and critical value reporting.
Traps
Questions often confuse validation (establishing performance of a new test) with verification (confirming performance of an established test in your lab). Another common trap: assuming CAP accreditation replaces CLIA (it does not; CAP is deemed authority but CLIA is the statutory requirement). Watch for confusion between analytic validity (does the test measure what it claims) and clinical validity (does the result correlate with disease).
Rule of thumb
New test → validation; existing/cleared test → verification. Both require documented performance characteristics before clinical use.
Worked example
A lab introduces a new NGS panel. Before clinical use, it must perform a validation documenting sensitivity, specificity, limit of detection, reproducibility, and reference ranges, and enroll in proficiency testing where available.