ArticlePloS one2025
Evaluation of pre-analytical specimen rejection using Six Sigma metrics: A retrospective single-center study.
Article in PloS one, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
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Who cites it
4 citing papers in PubMed.
- Evaluation of Pre-Analytical Performance Using IFCC Quality Indicators, Six Sigma Metrics and Root Cause Analysis in a Biochemistry Laboratory-A Retrospective Study.Diagnostics (Basel, Switzerland) · 2026Article
- Closed loop full process management and application of body fluid specimens in hospitalised patients.BMJ open quality · 2026Article
- A Hybrid Qualitative-Quantitative FMEA Model for Risk Management in Clinical Laboratory Automation: A Case Study Integrating ISO 15189:2022.Journal of clinical laboratory analysis · 2026Article
- Establishing denominator-consistent Six Sigma benchmarks for venous blood specimen rejection: a multi-center retrospective quality-indicator study using 21 million specimens in Western China.Frontiers in medicine · 2026Article
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundUp to 60% of errors occur in the pre-analytical stage of laboratory testing, potentially impairing clinical decision-making. This study aimed to assess pre-analytical errors using Six Sigma metrics and identify underlying causes for quality improvement.
methodsA retrospective analysis of pre-analytical sample errors was conducted over three years in a clinical laboratory. Errors were categorized, and Sigma values were calculated to assess quality. Trends over time were also analyzed.
resultsOf 2,068,074 samples, 2,214 (0.107%) were rejected. The top errors were clotted blood specimens (67.34%), insufficient volumes (8.22%), and cancelled test requests (6.28%), with Sigma values of 4.42, 5.25, and 5.32, respectively. The outpatient department performed best (Sigma = 5.47), while other wards required improvement.
conclusionEfforts are needed to reduce specimen rejection, particularly clotted samples, to enhance laboratory quality.
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