Practical application of Six Sigma management in analytical biochemistry processes in clinical settings
| Autor: | Bingfei Zhou, Hanlin He, Liming Tan, Yi Wu, Cunyan Li, Youde Cao |
|---|---|
| Rok vydání: | 2019 |
| Předmět: |
Quality Control
0301 basic medicine Microbiology (medical) Quality management Coefficient of variation Clinical Biochemistry quality assurance Biochemistry 03 medical and health sciences 0302 clinical medicine External quality assessment Humans Immunology and Allergy Research Articles Mathematics business.industry Biochemistry (medical) Public Health Environmental and Occupational Health Six Sigma Sigma Hematology Reference Standards Analytical Biochemistry Reliability engineering quality goal index Medical Laboratory Technology 030104 developmental biology root cause analysis 030220 oncology & carcinogenesis business Root cause analysis Quality assurance Research Article Total Quality Management |
| Zdroj: | Journal of Clinical Laboratory Analysis |
| ISSN: | 1098-2825 0887-8013 |
| DOI: | 10.1002/jcla.23126 |
| Popis: | Background Six Sigma methodology with a zero‐defect goal has long been applied in commercial settings and was utilized in this study to assure/improve the quality of various analytes. Methods Daily internal quality control (QC) and external quality assessment data were collected and analyzed by calculating the sigma (σ) values for 19 analytes based on the coefficient of variation, bias, and total error allowable. Standardized QC sigma charts were established with these parameters. Quality goal index (QGI) analysis and root cause analysis (RCA) were used to discover potential problems for the analytes. Results Five analytes with σ ≥ 6 achieved world‐class performance, and only the Westgard rule (13s) with one control measurement at two QC material levels (N2) per QC event and a run size of 1000 patient samples between QC events (R1000) was needed for QC. In contrast, more control rules (22s/R4s/41s) along with high N values and low R values were needed for quality assurance for five analytes with 4 ≤ σ |
| Databáze: | OpenAIRE |
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