Andrology Laboratory Quality Control and Quality Assurance
Core concepts
Distinguish quality control (QC), which monitors each run, from quality assurance (QA), the broader program including proficiency testing, audits, training, and corrective action. Know internal QC tools: control materials, replicate counts, monthly means, Levy-Jennings charts, and Westgard-style rules. Understand external quality assessment (EQA) and proficiency testing as requirements for accreditation. Recognize the importance of standard operating procedures, document control, equipment calibration and maintenance, temperature monitoring, and competency assessment. Know that semen analysis has high inter- and intra-observer variability, so replicate counting and periodic re-training are essential.
Traps
Questions conflate QC with QA, or assume a passed proficiency test guarantees ongoing accuracy. Watch for the trap that control materials for semen analysis are scarce and that many labs use replicate counts and video or image-based competency tests instead. Another trap: accepting a single abnormal QC point without investigating trends, or failing to document corrective action. Also be alert to the requirement for traceability of reagents and lot-to-lot verification, and to the fact that accreditation standards require documented competency assessment at defined intervals.
Worked example / rule of thumb
A control chart shows six consecutive points above the mean for concentration: apply a trend rule, investigate calibration, reagent lot, and technician, and document corrective action before reporting patient results. Rule of thumb: QC detects problems in a run; QA prevents them from recurring-always close the loop with documented corrective and preventive action.