Laboratory Operations, Regulatory Compliance, and Education
This domain tests quality control interpretation, safety rules, and the regulatory framework that governs personnel and competency.
QC, QA, and safety
- Levey-Jennings charts with Westgard rules: 1-2s is a warning, while 1-3s, 2-2s, R-4s, 4-1s, and 10x indicate rejection.
- Media QC each lot: sterility, growth promotion with appropriate ATCC strains, and productivity.
- Proficiency testing must be handled like patient samples; investigate a failure, document root cause and corrective action. Failure of the same analyte twice in a row carries serious consequences.
- Safety: OSHA bloodborne pathogens standard, PPE and sharps precautions, BSL-2 practices, UN3373 packaging for category B specimens, 1:10 bleach for spills, and autoclave monitoring.
Regulatory and education
- CLIA '88 (CMS), CAP, and The Joint Commission set test complexity, personnel qualifications, and quality systems requirements.
- Competency assessment covers six elements and is performed semiannually in the first year and annually thereafter.
- Document control requires approved, reviewed SOPs with version history.
Worked example
A proficiency-test challenge for C. difficile is falsely negative. Investigation shows the kit was used past its expiration date. Reasoning: PT failures must be investigated, not simply repeated, and the corrective action must address the system failure - inventory rotation and expiration checks - followed by retraining and documented monitoring.
Traps
Averaging QC values to force a pass; treating 1-2s as automatic rejection; signing off competency without direct observation; and ignoring PT results by testing them differently from patient specimens.