Precision Validation Report

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Precision Validation Systems

CLIA · CLSI · CAP Compliant Laboratory Validation Software

Report Number

VTL-PRE-20260818-9F3A

Date: 2026-08-18

Analyst: Maria Gonzalez, MLS(ASCP)

✅ Approved by Dr. Jane Sample, MD

2026-08-19T11:40

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CLIA PRECISION & IMPRECISION REPORT

Assay Parameter Analyte: Glucose
Max Allowable Imprecision Threshold: ≤5.0% CV

Instrument System Profile: Roche cobas c503 (S/N: SN-88214)
Reagent Lot Tracking Number: LOT-24A119
Approving Director: Dr. Jane Sample, MD

Replication Evaluation Matrix

Control Level	n	Mean (95% CI)	SD (95% CI)	%CV (95% CI)	Outliers	Prec. Index	σ Sigma	Status
Level 1 (Low QC)	20	64.97 [64.5566 — 65.3834]	0.8832 [0.6717 — 1.29]	1.36% [1.03% — 1.99%]	✓ 0	0.272	σ 7.36	✅ Pass
Level 2 (High QC)	20	280.445 [278.954 — 281.936]	3.1859 [2.4228 — 4.6532]	1.14% [0.86% — 1.66%]	⚠ 1	0.227	σ 8.8	✅ Pass

Clinical Evaluation Statements

Level 1 (Low QC) Narrative Summary:
PRECISION COMPLIANT (CLSI EP05 / CLIA §493.1253). Glucose [Level 1 (Low QC)]: CV = 1.36% is within the ≤5.0% limit. 95% CI for SD: [0.6717 — 1.2900]. Method repeatability meets performance specifications.

Level 2 (High QC) Narrative Summary:
PRECISION COMPLIANT (CLSI EP05 / CLIA §493.1253). Glucose [Level 2 (High QC)]: CV = 1.14% is within the ≤5.0% limit. 95% CI for SD: [2.4228 — 4.6532]. Method repeatability meets performance specifications.

📐 Six Sigma Quality Metrics by Level

Glucose [Level 1 (Low QC)]

σ 7.36

World Class

TEa: 10.0% · CV: 1.36%

Glucose [Level 2 (High QC)]

σ 8.8

World Class

TEa: 10.0% · CV: 1.14%

σ = (TEa% − |Bias%|) ÷ CV% · ≥6 World Class · ≥5 Excellent · ≥4 Good · ≥3 Marginal · <3 Poor
Higher sigma = fewer QC failures = less patient risk. Sigma ≥ 4 is acceptable for most clinical applications.

🎯 Quality Goals — Glucose [Level 1 (Low QC)] — TEa = 10.0%

TEa
10.0%

SEa (TEa/2)
5.0%

REa (TEa/2)
5.0% (CV 1.36% — ✓)

% of REa used
27.2%

🎯 Quality Goals — Glucose [Level 2 (High QC)] — TEa = 10.0%

TEa
10.0%

SEa (TEa/2)
5.0%

REa (TEa/2)
5.0% (CV 1.14% — ✓)

% of REa used
22.7%

▶ Raw Values — Glucose [Level 1 (Low QC)] (20 replicates)

Rep #	Value	Deviation from Mean	Flag
1	65.3	0.33	✓
2	64.0	-0.97	✓
3	65.8	0.83	✓
4	65.9	0.93	✓
5	63.0	-1.97	✓
6	63.7	-1.27	✓
7	65.1	0.13	✓
8	64.7	-0.27	✓
9	65.0	0.03	✓
10	64.1	-0.87	✓
11	65.9	0.93	✓
12	65.8	0.83	✓
13	65.1	0.13	✓
14	66.1	1.13	✓
15	65.5	0.53	✓
16	64.1	-0.87	✓
17	65.4	0.43	✓
18	64.0	-0.97	✓
19	65.9	0.93	✓
20	65.0	0.03	✓

▶ Raw Values — Glucose [Level 2 (High QC)] (20 replicates)

Rep #	Value	Deviation from Mean	Flag
1	279.3	-1.145	✓
2	277.3	-3.145	✓
3	284.9	4.455	✓
4	279.4	-1.045	✓
5	278.3	-2.145	✓
6	278.6	-1.845	✓
7	282.1	1.655	✓
8	281.5	1.055	✓
9	281.7	1.255	✓
10	281.7	1.255	✓
11	288.6	8.155	⚠ Outlier
12	278.4	-2.045	✓
13	278.0	-2.445	✓
14	276.7	-3.745	✓
15	282.5	2.055	✓
16	284.5	4.055	✓
17	279.5	-0.945	✓
18	276.6	-3.845	✓
19	276.7	-3.745	✓
20	282.6	2.155	✓

Electronically Signed By: Maria Gonzalez, MLS(ASCP), MLS-004821

Chemistry

Date: 2026-08-18 09:20

Maria Gonzalez, MLS(ASCP)
Medical Laboratory Technologist / Analyst Signature
Submitted: 2026-08-18T09:20

Electronically Signed By: Dr. Jane Sample, MD, MD-119284

Director / Supervisor of Clinical Laboratory

Date: 2026-08-19 11:40

Dr. Jane Sample, MD
Laboratory Director Approval Signature
Approved: 2026-08-19T11:40

Example Regional Medical Center — Clinical Laboratory

123 Laboratory Way, Sample City, ST 00000

CLIA: 00D0000000 · State Lic.: CLS-000000 · (555) 000-0000

Laboratory Director: Dr. Jane Sample, MD

Example Regional Medical Center — Clinical Laboratory

Generated by ValidToolsLab · CLIA §493.1256 Compliant

Report: VTL-PRE-20260818-9F3A · 2026-08-18