Laboratory QC Statistics and Formulas | Smart QC Manager
Scientific Reference

Statistical Methodology

An overview of the statistical formulas and QC concepts used by the application.

Quality Management

Concepts and calculations that can support laboratory quality control workflows.

Westgard Rules

Common statistical quality control rules used to review analytical results.

Measurement Uncertainty

An illustrative estimate using the calculation described on this page.

Core Statistics

ISO 15189 reference

The foundation of all laboratory quality control begins with basic descriptive statistics.

Observed Mean (Average)
x̄ = Σx / n

The arithmetic average of your laboratory's actual QC results.

Assigned SD (Reagent)
sa = (High - Mean) / 3

Standard Deviation derived from manufacturer reagent limits. Used for LJ grid lines.

Observed SD (Lab)
so = √[Σ(x - x̄)² / (n - 1)]

Actual measured precision of your laboratory instruments.

Performance Metrics

Clinical Standards

How well is your lab performing against manufacturer targets?

Bias (Systematic Error)
Bias = x̄obs - x̄target

Measures the signed difference between the observed mean and the target mean.

Bias %
Bias% = (Bias / x̄target) × 100

Expresses systematic error as a relative percentage of the target mean.

CV% (Precision Index)
CV% = (so / x̄obs) × 100

Measures the relative precision of your QC runs.

SDI (Z-Score)
SDI = Bias / starget

Indicates how many standard deviations your mean is from the target.

Measurement Uncertainty (MU)

Official GUM Protocol
ISO/IEC Guide 98-3 (GUM)

This page illustrates a Root Sum Square (RSS) calculation combining observed standard deviation and bias. It is an educational simplification and should not be treated as a validated uncertainty budget or a claim of conformity with a standard.

1. Combined Standard Uncertainty (uc)

uc = √((Observed SD)² + (Bias)²)

We use the root sum of squares (RSS) to combine precision (Observed SD) and systematic error (Bias).

2. Expanded Uncertainty (U)

U = k × uc

By default, we use a coverage factor (k) of 2, which provides approximately 95% coverage under common normal-distribution assumptions in the reported range.

3. Relative Expanded Uncertainty (U%)

U% = (U / x̄) × 100

Expresses the expanded uncertainty as a percentage of the observed mean.

Levey-Jennings & Westgard

Westgard.com Reference

The application automatically monitors your data against standard Westgard rules:

SD1

Within limits: Result within ±2.0 SD.

SD2

Warning: Result beyond ±2.0 SD but within ±3.0 SD.

OUT

Out: Result exceeds ±3.0 SD (Westgard 13s). Review the result according to your laboratory's QC procedure.