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Vojislav Stoiljković, Jasmina Trajković and Bratislav Stoiljković

Lean Six Sigma Sample Analysis Process in a Microbiology Laboratory

Faced with shrinking budgets, growing volumes, and personnel shortages, clinical laboratories are increasingly moving to automation to maximize output and efficiency. The best tool for improvement is the Lean Six Sigma concept. The concept reaps the full benefits of automation. A Lean process in a laboratory is focused on testing products and materials to deliver results in the most efficient way in terms of cost, speed, or both. The goal of a Lean laboratory is to use less effort, less resources and less time to test incoming samples. On the other hand, the Six Sigma concept provides process workflow and products/services without defects. The Lean Six Sigma approach analyzes laboratory workflow to help identify inefficiencies and uncover opportunities to free capacity, reduce turnaround time and lower costs. The assessment examines the end-to-end process looking closely at workflow as well as overall laboratory efficiency. The proven techniques of Lean and Six Sigma enhance productivity in the laboratory environment and ensure the best outcomes. This article analyzes a particular process, defines the approach, and gives a review of results obtained by deployment of the Lean Six Sigma concept. The article discusses a sample analysis process in a microbiology laboratory. A traditional process that applies standard analysis methods has a number of non-value-added activities, takes too much time, and has opportunities for defects. By mapping an existing process using a SIPOC model, 12 activities were identified. With the use of Lean tools four non-value-adding activities, which are not needed if a new system is used, were identified. Six activities had opportunities for improvement in terms of significant reduction in process time, and saving resources. Only two activities in the existing traditional process, with the use of standard analysis methods were optimally solved, and this did not require redesign or removal. The application of Lean Six Sigma concepts and automated analysis systems on a new process led to only nine activities in the process that now takes much less time and uses less resources. This article presents a description of the main principles, practices, and methods used in Lean and Six Sigma. The Lean tools particularly discussed here are 5s and spaghetti diagram. For Six Sigma, DMAIC methodology is used, and a review of applied quality tools for certain process improvement phases is given.

Open access

Vojislav Stoiljković, Peđa Milosavljević, Srđan Mladenović, Dragan Pavlović and Milena Todorović


Laboratories that are part of clinical centers are faced with the inevitability that their efficiency must be on a high level. Most of the biochemical laboratories are automated, but they are still underperforming. The best approach to increase the efficiency or to improve the processes today is the Lean Six Sigma methodology. This methodology extracts many benefits from automated processes. A lean process in the laboratory focuses on the time cycle to obtain results and reduce costs, or both components at the same time. Six Sigma methodology provides that the processes take place in the laboratory without delays and defects. The process that takes place at the Center for Medical Bio - chemistry (CMB) can be divided into two parts: the first part takes place in the receiving infirmary (pre-analytics) and the second part takes place at the offices of the CMB from the receipt of samples (analytics) to obtained results. The paper observes both processes, identifies critical areas where they come to a halt, defines access and reviews the results obtained using the Lean Six Sigma methodology. By applying Lean tools, the places that do not add value and those that significantly increase the cycle time were identified. This paper presents the results obtained without going into detail about the application of these Lean tools.

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Medical Journal of Cell Biology

The Journal of Foundation for Cell Biology and Molecular Biology

Open access

Rukiye Nar and Dilek Iren Emekli

. Turkish Journal of Biochemistry 2015; 40 (S1). 20. Ercan M, Bogdaycıo lu N, Akbulut ED, O uz E, Top cuo lu C et al. Assessment of the analytic performance for immunassay tests with six sigma methodology. Clin Chem Lab Med 2015; 53, Special Suppl, pp S1-S1450. 21. Aksoy N, Tekin NH, Bireroğlu N, Serin NO. Application of sigma metrics for immunoassay tests. Clin Chem Lab Med 2014; 52, Special Suppl, pp S1-S1760. 22. Theodorson E. Quality assurance in clinical chemistry: a touch of statistics and a lot of common sense. J Med

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Svetlana Savin, Dubravka Cvejić, Ljiljana Mijatović and Snežana Simonović

-Rasmussen U, Rasmussen AK. Serum thyroglobulin (Tg) in presence of thyroglobulin autoantibodies (TgAb). Clinical and methodological relevance of the interaction between Tg and TgAb in vitro and in vivo. J Endocrinol Invest 1985; 8: 571-6. Spencer CA, Takeuchi M, Kazarosyan M. Current status and performance goals for serum thyroglobulin assays. Clin Chem 1996; 42: 164-73. Žarković M. Diagnosis of thyroid disease. Principles and problems. Journal of Medical Biochemistry 2010; 29: 231-36. Clark PM

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Jelena Nestorov, Gordana Matić, Ivana Elaković and Nikola Tanić

amplification. Biotechniques 1998; 24: 954-8, 960, 962. 7. Zipper H, Brunner H, Bernhagen J, Vitzthum F. Investigations on DNA intercalation and surface binding by SYBR Green I, its structure determination and methodological implications. Nucleic Acids Res 2004; 32: e103. PMCID: 484200. 8. Ririe KM, Rasmussen RP, Wittwer CT. Product differentiation by analysis of DNA melting curves during the polymerase chain reaction. Anal Biochem 1997; 245: 154-60. 9. Clegg RM. Fluorescence resonance energy transfer and nucleic acids. Methods

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Vladimir Gasic, Biljana Stankovic, Branka Zukic, Dragana Janic, Lidija Dokmanovic, Nada Krstovski, Jelena Lazic, Goran Milosevic, Marianna Lucafò, Gabriele Stocco, Giuliana Decorti, Sonja Pavlovic and Nikola Kotur


Background: Long non-coding RNA growth arrest-specific 5 (GAS5) is deregulated in many cancers because of its role in cell growth arrest and apoptosis. Additionally, GAS5 interacts with glucocorticoid receptor, making it a potential pharmacotranscription marker of glucocorticoid (GC) therapy. In this study, we aimed at analysing GAS5 expression in the remission induction therapy phase of childhood acute lympho blastic leukemia (ALL), in which GCs are mandatorily used, and to correlate it with therapy response.

Methods: GAS5 expression was measured in peripheral blood mononuclear cells taken from 29 childhood ALL patients at diagnosis, on day 15 and day 33 of remission induction therapy using RT-qPCR methodology.

Results: Our results have shown interindividual differences in GAS5 expression at all time points. For each ALL patient, GAS5 expression was higher on day 15 in comparison to its level at diagnosis (p<0.0005). On day 33, the level of GAS5 expression decreased in comparison with day 15 (p<0.0005), but it was still significantly higher than at diagnosis for the majority of patients (p=0.001). Patients whose number of blasts on day 8 was below 100 per μL of peripheral blood had a higher GAS5 expression at diagnosis (p=0.016), and lower ratio day 15/diagnosis (p=0.009).

Conclusions: Our results suggest that the expression level of GAS5 could be a potential marker of therapy response in remission induction therapy of childhood ALL.

Open access

Sol Green

Improving the Preanalytical Process: The Focus on Specimen Quality

Trends in clinical laboratory practice place more demands on the quality of patient specimens. Advances in analytical performance (i.e., increased automation, reduced sample volume, increased assay sensitivity), as well as efficiency and cost reduction gains (i.e., throughput, test turnaround time) have improved medical practice. These changes, however, have caused an increased incidence of preanalytical errors, dictating the need for higher-quality specimens. The following paper addresses these errors in addition to methodologies for improving the quality of the preanalytical phase.

Open access

Davide Villa

Automation, Lean, Six Sigma: Synergies for Improving Laboratory Efficiency

The Pathology Services worldwide, surrounded by products are today requesting solutions. The approach aims towards the brain-to-brain cycle between caregivers and laboratory professionals. Despite budgets limited to 2-3% of total healthcare expenses, Laboratories are providing information for > 70% of medical actions. »Perianalytics« is becoming the focus; understanding information and sample flow in the whole journey and processes. Process analysis is the main component to understand and shape the best combination of components in designing a truly cost-effective Laboratory solution. Methodologies like Lean (or Toyota Production System) and Six Sigma have started recently to be adopted also in healthcare and in the Laboratory environment. Those techniques showed already successful implementations in healthcare, after their development in other sectors. Their tools are addressing the definition of »value«, »waste«, »flow« as key drivers to improve performances. The synergy among the methods allows decision makers to identify the degree of automation really necessary in their laboratory, with streamlined processes. The different platforms made available by industries, for in vitro diagnostic testing, could become not cost-effective or efficient without a careful assessment of needs, pathways and value-related variables. Total laboratory automation or stand-alone islands for systems can be identified and chosen after process mapping and recommendations deployed with Lean and Six Sigma techniques. This article highlights some key concepts of Lean and their fit in laboratory organization, as methodologies to be implemented before selecting and adopting automated systems.

Open access

Elisa Piva and Mario Plebani

The Esr Test: An Old Test With New Contents

The erythrocyte sedimentation rate (ESR) remains one of the most widely used laboratory tests. Its clinical usefulness and interpretation are in the monitoring of inflammatory diseases, in particular rheumatoid arthritis, temporal arteritis and polymyalgia rheumatica. At present, the reference method for measuring the ESR proposed by the International Committee for Standardization in Haematology (ICSH) utilizes EDTA-anticoagulated-undiluted blood to perform the test using the method described by Westergren in 1921. Current interest in the methodology focuses on the development of an automated closed system that allows the determination of the sedimentation rate with selected working methods, using a single sample for more than one haematological test, improving the bio-hazardous aspects of the testing procedures. As a consequence, standardization becomes necessary. ESR results should be reliable, despite the increased number of different methods and testing variables. Control materials and External Quality Assurance Schemes are now available, and should be used. In conclusion, innovative techniques may improve the appropriateness and usefulness of ESR in clinical practice, but in addition, they need to guarantee the traceability of results in comparison to the reference method in order to ensure comparability of results among different clinical laboratories.