Laboratory Operations / Management and Education
Quality framework
Quality assurance is the umbrella (policies, processes, audits); quality control is the statistical monitoring of each analytical run. Levey-Jennings charts with Westgard multirules detect random (1-3s) and systematic (2-2s, 4-1s, 10x) error. Method validation covers accuracy, precision, reportable range, analytical sensitivity, interference, and verification of the reference interval.
Regulatory and accreditation
CLIA defines testing complexity; moderate- and high-complexity laboratories must meet personnel, QC, and proficiency testing requirements. PT samples must be tested like patient samples and never referred to another laboratory. CAP adds accreditation standards and inspections. Competency assessment is required initially, again at 6 months, and annually, covering six elements including direct observation and blind sample testing.
Safety and operations
OSHA bloodborne pathogens standards require an exposure control plan, hepatitis B vaccination, and PPE. Chemical hygiene plans address hazardous reagents. Lean and Six Sigma target waste and variation; root cause analysis follows incidents. LIS interfaces must be validated before use.
Traps
- Treating a single QC failure as random error without investigation.
- Sharing proficiency testing results with another laboratory.
- Documenting competency with a written test alone.
Worked example: If a 2-2s rule fires across two control levels, suspect systematic error (calibration shift, reagent lot) and stop reporting until the cause is resolved.