PreciMind QC-IS
Quality Control Intelligence System — a multi-layer deterministic decision-support system that transforms QC data into structured decisions, error classifications, and clinically relevant risk assessments.
Input & Computation
System Positioning
QC-IS is a multi-layer laboratory quality intelligence system that transforms QC data into actionable decisions and clinically relevant insights.
Layer 1 — Data Input
Configure analyte, method, and analytical parameters for the intelligence pipeline.
Long-term between-run CV — min. 20 IQC points over ≥20 days (CLSI EP5-A3).
From EQA peer group or certified reference material. Negative = underestimation.
Total Allowable Error. CLIA = regulatory minimum. Biol. Variation = clinical optimum.
Interpretation Guide
Sigma Formula
σ = (TEa − |Bias|) ÷ CV
QC-IS Decision Thresholds
- ≥ 6σ → Accept · Severity: Minimal
- 4–6σ → Accept with monitoring · Severity: Moderate
- 3–4σ → Investigate · Severity: Moderate
- < 3σ → Reject run · Severity: Critical
Evidence & References
Westgard JO, Barry PL & Hunt MR (1981)
A multi-rule Shewhart chart for quality control in clinical chemistry. Clinical Chemistry 27(3):493–501.
Westgard JO (2016)
Six Sigma Quality Design and Control. 3rd ed. Westgard QC, Madison, WI.
CLSI EP23-A (2011)
Laboratory Quality Control Based on Risk Management.
CLSI EP5-A3 (2014)
Evaluation of Precision of Quantitative Measurement Procedures.
ISO 15189:2022 §7.3.6
Medical laboratories — Requirements for quality and competence.
Parvin CA (2008)
Assessing the impact of the frequency of QC testing on the quality of results. Clinical Chemistry 54(12):2049–2054.
QC-IS operates as a 6-layer deterministic pipeline: Data Input → Analytical Engine → Rule Engine → Interpretation Engine → Decision Engine → Clinical Risk Engine. Each layer produces structured outputs. Decision logic is rule-based, reproducible, and publication-transparent.
PM Lab Suite
Clinical Laboratory Intelligence Platform
When to Use
- IQC strategy design and rule selection for any quantitative method
- Method validation after reagent/calibrator lot changes
- ISO 15189, NABL, CLIA, JCI, CAP accreditation preparation
- Risk assessment for methods near clinical decision thresholds
- QC incident investigation and root cause analysis support
- Teaching QC intelligence principles in laboratory medicine education
Common Pitfalls
- Using within-run CV instead of long-term between-run CV (min. 20 IQC points, ≥20 days)
- Applying CLIA TEa limits as clinical targets — they are regulatory minimums only
- Ignoring bias in sigma calculation — even 1–2% bias significantly reduces sigma
- Treating sigma as a stable property — it changes with reagent lot, calibration, and instrument state