Westgard Rules in Laboratory
Quality Control
Haidar Khan
Understanding Westgard Rules in
Laboratory Quality Control
• Developed by Dr. James Westgard.
• A statistical approach to monitor quality
control (QC) performance.
• Helps detect analytical errors and maintain
test accuracy and precision.
• Integral part of ISO 15189 and CLIA quality
management systems.
Importance in Laboratory Practice
• Ensures reliability and validity of laboratory
test results.
• Detects systematic and random errors before
they affect patient reports.
• Maintains consistency across runs and
instruments.
• Strengthens internal quality control (IQC)
procedures.
Basic Concept of Westgard Rules
• Based on Levey-Jennings Charts.
• Uses Standard Deviation (SD) limits to identify
acceptable QC performance.
• Control results plotted against mean (±2SD,
±3SD).
• Rules applied to interpret whether the test
run is 'in control' or 'out of control.'
Types of Errors Detected
• Random Error: Caused by unpredictable
variations (pipetting, instrument noise).
• Systematic Error: Caused by consistent bias
(calibration drift, reagent deterioration).
• Westgard rules help differentiate and detect
both types effectively.
Westgard Rules Overview
• 1₍2s₎: One control exceeds ±2 SD (warning) → Possible
random/systematic error.
• 1₍3s₎: One control exceeds ±3 SD → Random error.
• 2₍2s₎: Two consecutive controls exceed ±2 SD on same
side → Systematic error.
• R₍4s₎: Range between two controls > 4 SD (one high,
one low) → Random error.
• 4₍1s₎: Four consecutive controls exceed ±1 SD on same
side → Systematic error.
• 10₍x̄₎: Ten consecutive results on same side of mean →
Systematic error.
Practical Application in Labs
• Run daily QC samples alongside patient
specimens.
• Plot QC results on Levey-Jennings charts.
• Apply Westgard rules to interpret QC data.
• If rule violation occurs:
- Stop patient testing.
- Identify and correct the source of error.
- Repeat QC before resuming testing.
Example Case Study
• Scenario: Two consecutive controls fall above
+2SD.
• Rule violated: 2₍2s₎.
• Indicates a systematic error.
• Action: Check calibration, reagent lot, and
instrument maintenance.
Benefits of Using Westgard Rules
• Early error detection.
• Improved accuracy and reliability of results.
• Reduced risk of reporting erroneous patient
data.
• Strengthened confidence in analytical
processes.
• Supports compliance with accreditation
standards (ISO 15189, CAP).
Limitations
• May be complex for small labs without
automated QC software.
• Requires proper training for correct
interpretation.
• Overuse of rules can lead to unnecessary false
rejections.
Summary
• Westgard Rules are essential for maintaining
analytical quality.
• Combine statistical control with professional
judgment.
• A key part of every laboratory’s internal
quality assurance program.
References
• Westgard JO, Barry PL. Quality Control Rules
and Charts in Laboratory Practice.
• CLSI C24-A3: Statistical Quality Control for
Quantitative Measurement Procedures.
• ISO 15189: Medical Laboratories –
Requirements for Quality and Competence.
