Interest and limits of the six sigma methodology in medical laboratory

Scherrer, Florian; Bouilloux, Jean-Pierre; Calendini, Ors’Anton; Chamard, Didier; Cornu, François

doi:10.1684/abc.2016.1216

Cited by 6 publications

(6 citation statements)

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“…The main difficulty in using the six sigma methodology lies in the absence of official guidelines for the definition of the total error acceptable. 11 We have analysed 13 analytes over a period of 12 months (July 2016 -July 2017) and assessed for sigma metrics. We have only 3 analytes ALP, Triglyceride (L2) and HDL that shows satisfactory sigma value, i.e.…”

Section: Discussionmentioning

confidence: 99%

Implementation of Sigma Metrics for Evaluation of Analytical Quality in Clinical Biochemistry Laboratory of a Tertiary Care Hospital

Choudhury¹,

Banerjee²,

Chakraborty³

2018

jemds

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BACKGROUND Amelioration of analytical quality in clinical laboratories is recognised as an emerging concern worldwide. Quality has been described as conformance to the requirement of users and the satisfaction of their needs and expectations. Quality assurance is need of the hour in all sectors including laboratory service. Six sigma provides a general methodology to describe performance on sigma scale. The present study was undertaken to evaluate the quality of the analytical performance of clinical biochemistry laboratory with the help of sigma metrics. MATERIALS AND METHODS Internal quality control (QC) data for both levels of control, L1 (normal) and L2 (high) obtained from clinical biochemistry laboratory of College of Medicine and Sagore Dutta Hospital were analysed over a period of one year from July 2016 to July 2017. Laboratory mean, standard deviation(SD) and coefficient of variation (CV %) were calculated for parameters like sugar, urea, creatinine, triglyceride, cholesterol, High Density Lipoprotein (HDL), Bilirubin, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), total protein, albumin and uric acid. Sigma factor was calculated using both levels of internal QC for the above-mentioned parameters. RESULTS Parameters such as ALP, Triglyceride (L2) and HDL with average sigma values (> 6) was considered as satisfactory. Parameters having average Sigma 3-6 relating to glucose, urea, creatinine (L2), ALT (L2), AST (L2), uric acid, Bilirubin total, Cholesterol (L1), Total protein and albumin were considered as acceptable, but needed close supervision. We got sigma < 3 for parameters like ALT (L1), AST (L1), Creatinine (L1) and Cholesterol (L2) which were unacceptable. CONCLUSION Sigma metrics thus calculated can be used as a guide for planning quality control strategy. The findings of our study will emphasise the need for evaluation of ongoing quality assurance programme and adoption of corrective and preventive measure. Ideal analytical methodology, quality control material and quality control strategy should be introduced to achieve uniform six sigma standards across all laboratories.

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Section: Discussionmentioning

confidence: 99%

Implementation of Sigma Metrics for Evaluation of Analytical Quality in Clinical Biochemistry Laboratory of a Tertiary Care Hospital

Choudhury¹,

Banerjee²,

Chakraborty³

2018

jemds

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“…The calculation of the Sigma value is the best risk predictor for laboratory testing but also a parameter used to design the selection of the statistical quality control method needed to detect errors (11). The Six Sigma metric corresponds to 3.4 errors per million determinations (12).…”

Section: O N L I N E F I R S Tmentioning

confidence: 99%

“…O N L I N E F I R S T (17,18,19). We can say that a more detailed evaluation of analytical performances is needed by strengthening quality control to achieve the highest possible level of six sigma for a medical laboratory, as some studies have shown (2,12,(20)(21)(22)(23)(24)(25)(26)(27)(28)(29)(30)(31). The lowest sigma value was observed for the following parameters: sodium (17,19), potassium (18), chloride (2,17,22), urea (18,19,21,27), creatinine (22,26,27), total protein (2,22), albumin (2,22,23,27), cholesterol (17,18,22,27), total bilirubin (18,22,27), glucose (17,22), some tumor markers (Ca 125, AFP) (20) and some hormones (fT4, prolactin, testosterone, and insulin)…”

Section: Analytical Phase and Six Sigma Metricsmentioning

confidence: 99%

"Six SIGMA" standard as a level of quality of biochemical laboratories

Pašić¹,

Šeherčehajić²

2022

Sanamed

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The principal role of biochemical laboratories is responsibility for reliable, reproducible, accurate, timely, and accurately interpreted analysis results that help in making clinical decisions, while ensuring the desired clinical outcomes. To achieve this goal, the laboratory should introduce and maintain quality control in all phases of work. The importance of applying the Six SIGMA quality model has been analyzed in a large number of scientific studies. The purpose of this review is to highlight the importance of using six SIGMA metrics in biochemical laboratories and the current application of six SIGMA metrics in all laboratory work procedures. It has been shown that the six SIGMA model can be very useful in improving all phases of laboratory work, as well as that a detailed assessment of all procedures of the phases of work and improvement of the laboratory's quality control system is crucial for the laboratory to have the highest level of six SIGMA. Clinical laboratories should use SIGMA metrics to monitor their performance, as it makes it easier to identify gaps in their performance, thereby improving their efficiency and patient safety. Medical laboratory quality managers should provide a systematic methodology for analyzing and correcting quality assurance systems to achieve Six SIGMA quality-level standards.

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“…The sigma level is calculated from the total allowable error (TE A ) chosen by the laboratory, coefficients of variation (CVs) and biases that are objective data, characteristic of the method. The difficulty lies in the choice of the TE A , which can considerably modify the result of the Sigma level (7). There is currently a debate on the sigma calculation formula taking into account the bias (8).…”

Section: Unacceptable Practicementioning

confidence: 99%

Recommendations for the application and follow-up of quality controls in medical laboratories

Giannoli¹,

Albarède²,

Avellan³

et al. 2021

Biochem. med. (Online)

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This is a translation of the paper “Recommendations for the application and follow-up of quality controls in medical biology laboratories” published in French in the journal Annales de Biologie Clinique (Recommandations pour la mise en place et le suivi des contrôles de qualité dans les laboratoires de biologie médicale. Ann Biol Clin (Paris). 2019;77:577-97.). The recommendations proposed in this document are the result of work conducted jointly by the Network of Accredited Medical Laboratories (LABAC), the French Society of Medical Biology (SFBC) and the Federation of Associations for External Quality Assessment (FAEEQ). The different steps of the implementation of quality controls, based on a risk analysis, are described. The changes of reagent or internal quality control (IQC) materials batches, the action to be taken in case of non-conform IQC results, the choice of external quality assessment (EQA) scheme and interpretation of their results as well as the new issue of analyses performed on several automatic systems available in the same laboratory are discussed. Finally, the concept of measurement uncertainty, the robustness of the methods as well as the specificities of near-patient testing and rapid tests are described. These recommendations cannot apply for all cases we can find in medical laboratories. The implementation of an objective alternative strategy, supported with documented evidence, might be equally considered.

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Interest and limits of the six sigma methodology in medical laboratory

Cited by 6 publications

References 0 publications

Implementation of Sigma Metrics for Evaluation of Analytical Quality in Clinical Biochemistry Laboratory of a Tertiary Care Hospital

Implementation of Sigma Metrics for Evaluation of Analytical Quality in Clinical Biochemistry Laboratory of a Tertiary Care Hospital

"Six SIGMA" standard as a level of quality of biochemical laboratories

Recommendations for the application and follow-up of quality controls in medical laboratories

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