Laboratory Operations, Safety, and Quality Management
Core concepts
This domain tests management of the pathology laboratory as a regulated system. Know the hierarchy of standards: CLIA '88 as the federal baseline, CAP accreditation as the practical inspection standard, and OSHA for workplace safety. Understand personnel qualification categories (director, technical supervisor, general supervisor, testing personnel) and which duties each may perform. Know quality control vs. quality assurance vs. quality improvement: QC is the daily check (controls, calibration), QA is the monitoring of the system (indicators, audits), and QI is the intervention and re-measurement.
Safety content includes the OSHA Bloodborne Pathogens Standard (exposure control plan, engineering controls, PPE, hepatitis B vaccination offer, post-exposure evaluation), formalin and xylene hazard handling, chemical hygiene plans, and the requirement for a Safety Data Sheet (SDS) for each hazardous chemical. Know the fire triangle, the classes of fire extinguishers, and the meaning of the NFPA diamond. Specimen identification and labeling, the two-identifier rule, and the chain of custody for forensic or legal specimens are frequent question topics.
Traps
Questions blur QC and QA, or ask who may perform high-complexity testing. Others confuse a corrective action with a preventive action, or assume a safety inspection requirement applies to all labs when it is standard-specific. Watch for questions about proficiency testing (PT) - you must not refer PT specimens out or communicate results, and unacceptable PT performance triggers corrective action.
Worked rule
When a question asks about a failed control, the sequence is: stop testing, investigate the cause, correct it, document, and re-run the control before resuming patient testing. Never report patient results from a run with a failed control.