Lean Six-Sigma and their importance in continuous quality improvement in the clinical laboratory


  • William Antonio Lino Villacreses Universidad Estatal del Sur de Manabí Facultad de Ciencias de la Salud Jipijapa, Manabí, Ecuador.
  • Lorena Anahis Lino Villacreses Jipijapa, Manabí, Ecuador.
  • Jose Humberto Guaman Guanca Jipijapa, Manabí, Ecuador.


Quality, Clinical Laboratory, Learn Methodology, Six-Sigma


In clinical laboratories, the combination of Lean and Six Sigma methodologies can generate significant improvements in quality, productivity and patient safety, the implementation of these methodologies can help laboratories reduce errors, minimize waste and increase efficiency in the provision of diagnostic services, the use of Lean and Six Sigma methodologies can also help laboratories meet regulatory requirements and  Accreditation standards, ensuring that patients receive accurate and reliable test results, applying Lean and Six Sigma methodologies in clinical laboratories can lead to better patient outcomes and greater satisfaction with laboratory services. The objective of this research was to analyze the application of Lean Six Sigma in the clinical laboratory and how this methodology intervenes in the continuous improvement of quality in the Clinical Laboratory. The study is of design and type systematic documentary and bibliographic review, since searches were carried out in the various scientific databases: pubmed, scielo, Sciencedirect. The results indicate that Lean and Six Sigma process improvement methodologies are adequate to help achieve 98% laboratory efficiency. It was concluded that Lean Six Sigma is a powerful methodology that can help clinical laboratories improve their processes.


Woodnutt S. Is Lean sustainable in today’s NHS hospitals? A systematic literature review using the meta-narrative and integrative methods. International Journal for Quality in Health Care. 1 de octubre de 2018;30(8):578-86.

Hamelmann C, Turatto F, Then V, Dyakova M. Social return on investment: accounting for value in the context of implementing Health 2020 and the 2030 Agenda for Sustainable Development (Investment for Health and Development Discussion Paper) [Internet]. World Health Organization. Regional Office for Europe; 2017 [citado 8 de febrero de 2023]. Report No.: WHO/EURO:2017-2240-41995-57722. Disponible en: https://apps.who.int/iris/handle/10665/340348

Jones J, Saul R, Sathe L, Xie J, Marquette D, Arboleda VA. Lean Principles to Improve Quality in High-Throughput COVID-19 Testing Using SwabSeq: A Barcoded Sequencing-Based Testing Platform. Laboratory Medicine. 1 de enero de 2022;53(1):e8-13.

Carchio SM, Cappella AC, Goedelmann C, Pandolfo M, Bustos D. Aplicación de Seis Sigma en el Laboratorio Clínico. Acta bioquímica clínica latinoamericana. diciembre de 2019;53(4):525-37.

Ortiz Castro WD. Análisis Lean Six sigma de la fase preanalítica del proceso de Laboratorio Clínico del Hospital del IESS Ambato [Internet] [bachelorThesis]. Universidad Técnica de Ambato. Facultad de Ingeniería en Sistemas, Electrónica e Industrial. Carrera de Ingeniería Industrial en Procesos de Automatización; 2022 [citado 8 de febrero de 2023]. Disponible en: https://repositorio.uta.edu.ec:8443/jspui/handle/123456789/37005

Nkengasong JN, Yao K, Onyebujoh P. Laboratory medicine in low-income and middle-income countries: progress and challenges. Lancet. 12 de mayo de 2018;391(10133):1873-5.

Linsuke S, Nabazungu G, Ilombe G, Ahuka S, Muyembe JJ, Lutumba P. Laboratoires médicaux et qualité des soins: la partie la plus négligée au niveau des hôpitaux ruraux de la République Démocratique du Congo. Pan Afr Med J. 24 de enero de 2020;35:22.

Randell EW, Yenice S, Khine Wamono AA, Orth M. Autoverification of test results in the core clinical laboratory. Clinical Biochemistry. 1 de noviembre de 2019;73:11-25.

Kirwan JA, Gika H, Beger RD, Bearden D, Dunn WB, Goodacre R, et al. Quality assurance and quality control reporting in untargeted metabolic phenotyping: mQACC recommendations for analytical quality management. Metabolomics. 27 de agosto de 2022;18(9):70.

Kammergruber R, Durner J. Laboratory information system and necessary improvements in function and programming. Journal of Laboratory Medicine. 1 de diciembre de 2018;42(6):277-87.

Inal TC, Goruroglu Ozturk O, Kibar F, Cetiner S, Matyar S, Daglioglu G, et al. Lean six sigma methodologies improve clinical laboratory efficiency and reduce turnaround times. J Clin Lab Anal. 15 de febrero de 2017;32(1):e22180.

Ciulla TA, Tatikonda MV, ElMaraghi YA, Hussain RM, Hill AL, Clary JM, et al. LEAN SIX SIGMA TECHNIQUES TO IMPROVE OPHTHALMOLOGY CLINIC EFFICIENCY. Retina. septiembre de 2018;38(9):1688-98.

Johannessen KA, Alexandersen N. Improving accessibility for outpatients in specialist clinics: reducing long waiting times and waiting lists with a simple analytic approach. BMC Health Services Research. 1 de noviembre de 2018;18(1):827.

Thakur V, Akerele OA, Randell E. Lean and Six Sigma as continuous quality improvement frameworks in the clinical diagnostic laboratory. Critical Reviews in Clinical Laboratory Sciences. 17 de agosto de 2022;0(0):1-19.

Kaswan MS, Rathi R. Analysis and modeling the enablers of Green Lean Six Sigma implementation using Interpretive Structural Modeling. Journal of Cleaner Production. 10 de septiembre de 2019;231:1182-91.

Rathi R, Vakharia A, Shadab M. Lean six sigma in the healthcare sector: A systematic literature review. Materials Today: Proceedings. 1 de enero de 2022;50:773-81.

Albliwi SA, Antony J, Lim SA halim. A systematic review of Lean Six Sigma for the manufacturing industry. Business Process Management Journal. 1 de enero de 2015;21(3):665-91.

Raja Sreedharan V, Raju R. A systematic literature review of Lean Six Sigma in different industries. International Journal of Lean Six Sigma. 1 de enero de 2016;7(4):430-66.

Nair P, Barai I, Prasad S, Gadhvi K. Quality improvement teaching at medical school: a student perspective. AMEP. 18 de marzo de 2016;7:171-2.

Curry LA, Brault MA, Linnander EL, McNatt Z, Brewster AL, Cherlin E, et al. Influencing organisational culture to improve hospital performance in care of patients with acute myocardial infarction: a mixed-methods intervention study. BMJ Qual Saf. 1 de marzo de 2018;27(3):207-17.

Mannion R, Davies H. Understanding organisational culture for healthcare quality improvement. BMJ. 28 de noviembre de 2018;363:k4907.

Simons P, Backes H, Bergs J, Emans D, Johannesma M, Jacobs M, et al. The effects of a lean transition on process times, patients and employees. International Journal of Health Care Quality Assurance. 1 de enero de 2017;30(2):103-18.

Heneghan C, Mahtani KR, Goldacre B, Godlee F, Macdonald H, Jarvies D. Evidence based medicine manifesto for better healthcare. BMJ. 20 de junio de 2017;357:j2973.

Lawal AK, Rotter T, Kinsman L, Sari N, Harrison L, Jeffery C, et al. Lean management in health care: definition, concepts, methodology and effects reported (systematic review protocol). Syst Rev. 19 de septiembre de 2014;3:103.

Cohen RI. Lean Methodology in Health Care. Chest. diciembre de 2018;154(6):1448-54.

Jones B, Horton T, Warburton W. The improvement journey: why organisation-wide improvement in health care matters, and how to get started [Internet]. Health Foundation; 2019 may [citado 20 de diciembre de 2022]. Disponible en: https://apo.org.au/node/233101

Makary MA, Daniel M. Medical error—the third leading cause of death in the US. BMJ. 3 de mayo de 2016;353:i2139.

Gonzalez-Aleu F, Van Aken EM, Cross J, Glover WJ. Continuous improvement project within Kaizen: critical success factors in hospitals. The TQM Journal. 1 de enero de 2018;30(4):335-55.

Marin-Garcia JA, Vidal-Carreras PI, Garcia-Sabater JJ. The Role of Value Stream Mapping in Healthcare Services: A Scoping Review. International Journal of Environmental Research and Public Health. enero de 2021;18(3):951.

Hartzband P, Groopman J. Medical Taylorism. N Engl J Med. 14 de enero de 2016;374(2):106-8.

Schonberger RJ. Reconstituting lean in healthcare: From waste elimination toward ‘queue-less’ patient-focused care. Business Horizons. 1 de enero de 2018;61(1):13-22.

Poksinska BB, Fialkowska-Filipek M, Engström J. Does Lean healthcare improve patient satisfaction? A mixed-method investigation into primary care. BMJ Qual Saf. febrero de 2017;26(2):95-103.

Muenz Raquel. The Main Goal of Six Sigma Implementation [Internet]. Today’s Clinical Lab. 2020 [citado 8 de febrero de 2023]. Disponible en: https://www.clinicallabmanager.com/trends/the-automated-lab/the-main-goal-of-six-sigma-implementation-21937

Niñerola A, Sánchez-Rebull MV, Hernández-Lara AB. Quality improvement in healthcare: Six Sigma systematic review. Health Policy. abril de 2020;124(4):438-45.

Lakhiani C, Moroni E, Evans KK, Steinberg J, Kim PJ, Attinger CE. Abstract: Utility of Six Sigma Methodology for Improving Quality and Safety in a Large Surgical Service: A Resident Driven Protocol. Plast Reconstr Surg Glob Open. 2 de octubre de 2017;5(9 Suppl):102-3.

Hynes JP, Murray AS, Murray OM, Eustace SK, Gilchrist S, Dolan A, et al. Use of Lean Six Sigma methodology shows reduction of inpatient waiting time for peripherally inserted central catheter placement. Clin Radiol. septiembre de 2019;74(9):733.e5-733.e9.

Sugianto JZ, Stewart B, Ambruzs JM, Arista A, Park JY, Cope-Yokoyama S, et al. Applying the Principles of Lean Production to Gastrointestinal Biopsy Handling: From the Factory Floor to the Anatomic Pathology Laboratory. Lab Med. 2015;46(3):259-64.

Abu Bakar FA, Subari K, Mohd Daril MA. Critical success factors of Lean Six Sigma deployment: a current review. International Journal of Lean Six Sigma. 1 de enero de 2015;6(4):339-48.

O’Mahony L, McCarthy K, O’Donoghue J, Teeling SP, Ward M, McNamara M. Using Lean Six Sigma to Redesign the Supply Chain to the Operating Room Department of a Private Hospital to Reduce Associated Costs and Release Nursing Time to Care. International Journal of Environmental Research and Public Health. enero de 2021;18(21):11011.

Teeling SP, Dewing J, Baldie D. A Discussion of the Synergy and Divergence between Lean Six Sigma and Person-Centred Improvement Sciences. International Journal of Research in Nursing. 13 de abril de 2020;11(1):10-23.

Pradhan DP, Pandit D, Sahoo S, Rattan R, Mohanty S. Six Sigma Metrics: An Evolving Indicator of Quality Assurance for Clinical Biochemistry. JCDR [Internet]. 2022 [citado 8 de febrero de 2023]; Disponible en: https://www.jcdr.net//article_fulltext.asp?issn=0973-709x&year=2022&month=August&volume=16&issue=8&page=BC14-BC18&id=16718

Ibrahim I, Sultan M, Yassine OG, Zaki A, Elamir H, Guirguis W. Using Lean Six Sigma to improve timeliness of clinical laboratory test results in a university hospital in Egypt. International Journal of Lean Six Sigma. 1 de enero de 2022;13(5):1159-83.

McDermott O, Antony J, Bhat S, Jayaraman R, Rosa A, Marolla G, et al. Lean Six Sigma in Healthcare: A Systematic Literature Review on Motivations and Benefits. Processes. octubre de 2022;10(10):1910.

Miño R, Reinoso K, Salazar X, Galarza S. Incidentes preanalíticos en muestras biológicas en el Laboratorio Clínico del Hospital de Especialidades Eugenio Espejo (HEEE) Quito – Ecuador 2016. REFLEXIONES Revista científica del Hospital Eugenio Espejo [Internet]. 19 de marzo de 2022 [citado 22 de febrero de 2023];19(1). Disponible en: http://rev-reflexiones.hee.gob.ec/ojs-3.1.2/index.php/reflexiones/article/view/3

Apostu SA, Vasile V, Veres C. Externalities of Lean Implementation in Medical Laboratories. Process Optimization vs. Adaptation and Flexibility for the Future. International Journal of Environmental Research and Public Health. enero de 2021;18(23):12309.

Huq Ronny F, Almadani M, Fallon J, Adem P. Lean six sigma process improvement in specimen receiving to improve stat chemistry turnaround times. Modern Medical Laboratory Journal. 10 de enero de 2021;4(1):1-4.

Kanani FZ, Kazmi AH, Kaleem B. La métrica Sigma del sistema Alinity ci: estudio sobre 39 magnitudes químicas y de inmunoensayo. Advances in Laboratory Medicine / Avances en Medicina de Laboratorio. 1 de junio de 2021;2(2):277-85.

Cazarré V, Pedernera JA, Vallory JH, Lujan PR. Evaluación del desempeño del proceso de recepción de pacientes en un laboratorio clínico. Revista Bioquímica y Patología Clínica. 2020;84(2):43-8.

Quevedo MCC, Martén RA, Serra LR, Brown YC. Evaluación de la calidad de los procesos analíticos en un laboratorio clínico mediante el cálculo del error total y la métrica seis sigma. MediSan. 2019;23(03):495-508.

García EJA, Peñate E, Núñez G, Montilla C, Vásquez R. Competencias y desempeño de laboratorios clínicos en la determinación de colesterol y triglicéridos. Rev Mex Patol Clin Med Lab. 18 de febrero de 2019;65(4):192-9.

Salazar-Agudelo SC, Ruiz-Cadavid A, Salazar JV. Incremento en la medición sigma por la implementación de estrategias en inmunoquímica del Laboratorio Médico Echavarría. Rev Mex Patol Clin Med Lab. 24 de julio de 2019;66(1):46-52.

Weiss VL, Heher YK, Seegmiller A, VanderLaan PA, Nishino M. All in for patient safety: a team approach to quality improvement in our laboratories. Journal of the American Society of Cytopathology. 1 de marzo de 2022;11(2):87-93.

Gupta P, Thomas M, Sbetan N, Chacko G, Savarimuthu I, Cherian P, et al. A Quality Improvement Initiative to Reduce Rejected Laboratory Samples and Enhance Specimen Acceptability. The Joint Commission Journal on Quality and Patient Safety. 1 de agosto de 2021;47(8):519-25.

Kachuwaire O, Zakaryan A, Manjengwa J, Davtyan Z, Châtard J, Orelle A, et al. Quality management system implementation in human and animal laboratories. One Health. 1 de diciembre de 2021;13:100278.

White TE, Wong WB, Janowiak D, Hilborne LH. Strategies for laboratory professionals to drive laboratory stewardship. Practical Laboratory Medicine. 1 de agosto de 2021;26:e00249.

Zohoun A, Agbodandé TB, Kpadé A, Goga RO, Gainsi R, Balè P, et al. From benchmarking to best practices: Lessons from the laboratory quality improvement programme at the military teaching hospital in Cotonou, Benin. African Journal of Laboratory Medicine. 2021;10(1):1-7.

Gómez-Sanz JE, Gallego-Gavela V, Simón-Sacristán M, Mateo-Maestre M, Jiménez-Garofano MC, Virseda-Chamorro I, et al. Estrategias para la implantación de un sistema de gestión de la calidad en los laboratorios clínicos del Hospital Central de la Defensa Gómez Ulla. Sanidad Militar. diciembre de 2020;76(4):245-53.

Lee NY. Reduction of pre-analytical errors in the clinical laboratory at the University Hospital of Korea through quality improvement activities. Clinical Biochemistry. 1 de agosto de 2019;70:24-9.

Pacheco AB, Zamory ES, Collino CJG. Impacto de la implementación de un sistema documental en el aseguramiento de la calidad en un laboratorio de análisis clínicos de un hospital público. Acta bioquímica clínica latinoamericana. diciembre de 2019;53(4):511-24.

Musabaike W, Wu Y, Morris C, Heales S. 063 Quality improvement project on reducing laboratory sample rejection due to pre-analytical errors – improving patient experience, quality and efficiency. Archives of Disease in Childhood. 1 de diciembre de 2018;103(Suppl 2):A26-A26.

Hooper JE, Richardson H, Maters AW, Carroll KC, Pronovost PJ. The Association of Departmental Quality Infrastructure and Positive Change: A Pathology Department Illustration. Academic Pathology. 1 de enero de 2018;5:2374289517744753.

Pasic A, Sehercehajic E. “SIX SIGMA” STANDARD AS A LEVEL OF QUALITY OF BIOCHEMICAL LABORATORIES. 1 [Internet]. 8 de diciembre de 2022 [citado 7 de febrero de 2023];17(3). Disponible en: https://aseestant.ceon.rs/index.php/sanamed/article/view/40408

Nagaraj RB, Ansari MKA, Shivanna D, Mariyappa BD. Evaluation of Quality Control in Clinical Hematology laboratory by using Six- Sigma. Annals of the Romanian Society for Cell Biology. 10 de julio de 2021;20354-9.

Gopolang F, Zulu-Mwamba F, Nsama D, Kruuner A, Nsofwa D, Kasvosve I, et al. Improving laboratory quality and capacity through leadership and management training: Lessons from Zambia 2016-2018. Afr J Lab Med. 2021;10(1):1225.

A M, B S, Hn J, D S. Quality improvement in clinical biochemistry laboratory using six sigma metrics and quality goal index. J Med Sci Res. 19 de abril de 2021;9(2):101-7.

Zhou B, Wu Y, He H, Li C, Tan L, Cao Y. Practical application of Six Sigma management in analytical biochemistry processes in clinical settings. Journal of Clinical Laboratory Analysis. 2020;34(1):e23126.

Girma M, Deress T, Adane K. Laboratory Quality Management System and Quality Indicators Implementation Status as Perceived by Laboratory Professionals in Preparation for the Accreditation Process from Selected Government Hospitals of Ethiopia. Clin Lab. 1 de abril de 2020;66(4).

Rodríguez-Jacobo, I., Galindo-López, F. J., Aguirre-García, J., Navarro-Villarruel, C. L., Castro-Almanza, M. C., Eufrasio-Maciel, A. R., ... (2020). Estandarización de una técnica eficiente para el reporte de UFC / mL en muestras de orina con citolisis celular bacteriana. Journal of Microbiology &Amp; Health Education, 2(1), 30–34.

Zorbozan O, Zorbozan N, Turgay N. [Evaluation of Pre-analytical Process with Quality Indicators and Six Sigma Methodology in the Parasitology Laboratory of a Tertiary Healthcare Center]. Mikrobiyol Bul. julio de 2019;53(3):319-29.

Cruz Sanabria A. Vision of a Microbiology Laboratory of Excellence using Lean Methodology. 2018 [citado 7 de febrero de 2023]; Disponible en: https://prcrepository.org:443/xmlui/handle/20.500.12475/88

Pérez FL. The Six Sigma model in the Hematology internal quality control assessment. Rev Esp Cienc Salud. 15 de enero de 2017;18(2):5-8.

Messinger BL, Rogers DN, Hawker CD. Use of Automation and Process Improvement to Achieve a Six Sigma Level of Nonanalytic Quality. The Journal of Applied Laboratory Medicine. 1 de julio de 2017;2(1):86-91.

Ahmed S, Abd Manaf NH, Islam R. Measuring Lean Six Sigma and quality performance for healthcare organizations. International Journal of Quality and Service Sciences. 1 de enero de 2018;10(3):267-78.

Akmal A, Greatbanks R, Foote J. Lean thinking in healthcare – Findings from a systematic literature network and bibliometric analysis. Health Policy. 1 de junio de 2020;124(6):615-27.



How to Cite

Lino Villacreses, W. A. ., Lino Villacreses , L. A. ., & Guaman Guanca, J. H. . (2023). Lean Six-Sigma and their importance in continuous quality improvement in the clinical laboratory. Journal of Microbiology &Amp; Health Education, 5(3), 571–581. Retrieved from http://journalmhe.org/ojs3/index.php/jmhe/article/view/85