Abstract
BackgroundSix 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.MethodsDaily 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.ResultsFive 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 < 6. However, the sigma levels of nine analytes were σ < 4 at one or more QC levels, and a more rigorous QC procedure (13s/22s/R4s/41s/8x with N4 and R45) was implemented. The combination of QGI analysis and RCA further revealed inaccuracy or imprecision problems for these analytes with σ < 4 and discovered five aspects of potential causes considered for quality improvement.ConclusionsSix Sigma methodology is an effective tool for evaluating the performance of biochemical analytes and is conducive to quality assurance and improvement.
Highlights
The current clinical study examined the utility of internal quality control (IQC) and external quality control (EQC) for the quality assurance (QA) of biochemical analytes
The Six Sigma methodology was evaluated in our work
This phenomenon could be attributed to two points: One was the detection system, including the different types of analyzers, reagents, and QC materials used, as well as other pre-analytical and analytical conditions; and the other was the source selection of the total error allowable (TEa) targets and the slight differences in the algorithms used to evaluate the bias and coefficient of variation (CV), which might affect the sigma values
Summary
The current clinical study examined the utility of internal quality control (IQC) and external quality control (EQC) for the quality assurance (QA) of biochemical analytes. The performance of 19 analytes was evaluated by calculating sigma values from the coefficient of variation (CV), bias, and total error allowable (TEa). Quality goal index (QGI) analyses and root cause analysis (RCA) were further performed to identify problems related to the measurement procedures for analytes with a sigma value below 4. The construction of the standardized QC sigma charts obeyed the concept of previously reported studies.[12,13] This approach allows a laboratory to obtain an audiovisual and comprehensive view of the performance of all the analytes in a single graph at every control measurement level and with every instrument module
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