Application of the Six Sigma metrics in clinical laboratories: an integrative review
DOI:
https://doi.org/10.34119/bjhrv8n6-347Keywords:
Six Sigma, clinical laboratory, systematic review, quality indicators, advantages and limitationsAbstract
Six Sigma is recognized as a successful methodology and its implementation in any company aims to optimize processes, mitigate error rates, improve quality, and, consequently, increase customer satisfaction. Sigma metrics can be obtained using different statistical applications and commonly classify companies into three stages. Approximately 70-80% of medical decisions are made with the help of a clinical laboratory. The organization and process flow in a clinical laboratory are divided into multiple and complex steps and this fact requires using powerful tools to guarantee total quality. For this reason, Six Sigma can be used for this purpose and this work proposes an integrative review of the application of Six Sigma in clinical laboratories, observing their scope of use, effects, quality indicators, and possible limitations of its application. After the use of eligibility and exclusion criteria, nine studies were selected. The results showed that the Six Sigma in clinical laboratories is distributed in public and private laboratories, located in hospitals, and universities. There is a significant increase in the use of this tool. Different indicators are used in Six Sigma, but most have with focus on pre-analytical and analytical phases and not on the general evaluation of laboratories. There is not a considerable global distribution of studies related to the application of Six Sigma and they are generally associated with laboratories involved in international accreditation processes. Finally, different existing limitations need to be observed for the interpretation of the results obtained from Six Sigma.
References
ALBERTO, A P; FARIA, A; MIRANDA, A, CORREIA, H; CONSTANTINO, V; REQUEIJO, J G. Aplicação da metodologia Seis Sigma nos parâmetros colesterol total, colesterol LDL e triglicéridos. Boletim Epidemiológico Observações, v. 11, n. 31, p. 39-43, 2022.
ASMELASH, D; WOREDE, A; TESHOME, M. Extra-analytical clinical laboratory errors in Africa: a systematic review and meta-analysis. Ejifcc, v. 31, n. 3, p. 208, 2020.
ARAFEH, M. Combining Lean Concepts & Tools with the DMAIC Framework to Improve Processes and Reduce Waste. American Journal of Operations Research, v. 5, n. 03, p. 209, 2015.
BLICK, K E. Providing critical laboratory results on time, every time to help reduce emergency department length of stay: how our laboratory achieved a Six Sigma level of performance. American journal of clinical pathology, v. 140, n. 2, p. 193-202, 2013.
CARCHIO, S M; CAPPELLA, A C; GOEDELMANN, C ; PANDOLFO, M; BUSTOS, D.Aplicación de Seis Sigma en el Laboratorio Clínico. Acta bioquímica clínica latinoamericana, v. 53, n. 4, p. 525-537, 2019.
CARVALHO, A R; OLIVEIRA, O L M. Métrica Seis Sigma em análises clínicas e a qualidade na rotina laboratorial. Revista Brasileira de Análises Clínicas, p. 375-380, 2021.
CHANDRA, S; KUSUM, A; GAUR, D S; CHANDRA H. Analytical and post analytical phase of an ISO 15189: 2012 Certified cytopathology laboratory-a five year institutional experience. Journal of Cytology, v. 39, n. 1, p. 37, 2022.
CHASSIN, M R. Is health care ready for Six Sigma quality?. The Milbank Quarterly, v. 76, n. 4, p. 565-591, 1998.
DAMATO, C; RICKARD, D. Utilização do Lean-Six Sigma para redução de hemólise no pronto-socorro em projeto colaborativo de melhoria da qualidade com o laboratório do hospital. The Joint Commission Journal on Quality and Patient Safety , v. 3, pág. 99-AP1, 2015.
DAVISON, L; AL-SHAGHANA, K. The link between Six Sigma and quality culture–an empirical study. Total Quality Management & Business Excellence, v. 18, n. 3, p. 249-265, 2007.
DIAS, V S; BARQUETTE, F R S; BELLO, A R. Padronização da qualidade: alinhando melhorias contínuas nos laboratórios de análises clínicas. RBAC, v. 49, n. 2, p. 164-9, 2017.
ELBIREER A; LE CHASSEUR J; JACKSON B. Improving laboratory data entry quality using Six Sigma. Int J Health Care Qual Assur. v. 26, n. 6, p.496-509, 2013
GETO, Z; Getahun, T; LEJISA, T; JIRU, Y T. Rule Selection and Implementation of Internal Quality Control in Clinical Chemistry Reference Laboratory, Ethiopian Public Health Institute. Indian Journal of Clinical Biochemistry, v. 37, n. 1, p. 1-9, 2022.
GIRMANOVÁ, L; SOLK, M; KLIMENT, J; DIVOKOVÁ, A. Application of Six Sigma using DMAIC methodology in the process of product quality control in metallurgical operation. Acta technologica agriculturae, v. 20, n. 4, p. 104-109, 2017.
HASSAN MOHAMMED YASSIN, A; ELZEIN ABUKASSAWI OSMAN, N; ABEDELMONEM BEN KHALIFA, W; NOUH MOHAMMED ADAM, E. An Application for Measuring and Analyzing the Level of Performance Accuracy for Health Services Quality Indicators by Using Six Sigma: A Study Case of Government Hospitals in Khartoum State. Journal of Healthcare Engineering, v. 2021, 2021.
HAWKINS, R. Managing the pre-and post-analytical phases of the total testing process. Annals of laboratory medicine, v. 32, n. 1, p. 5-16, 2012.
INAL; T C; GORUROGLU OZTURK, O; KIBAR, F; CETINER, S; MATYAR, S; DAGLIOGLU, G; YAMAN, A. Lean six sigma methodologies improve clinical laboratory efficiency and reduce turnaround times. Journal of clinical laboratory analysis, v. 32, n. 1, p. e22180, 2018.
JHA, P K; SHARMA, N; CHANDRA, J; AGARWAL, R. Evaluation of sigma-metrics and application of quality tools in clinical laboratory of a tertiary care hospital. Indian Journal of Clinical Biochemistry, v. 36, n. 3, p. 337-344, 2021
KALRA, J; KOPARGAONKAR, A. Quality improvement in clinical laboratories: a six sigma concept. Pathology and Laboratory Medicine, v. 1, n. 1, p. 11-20, 2016.
KNAPP, S. Lean Six Sigma implementation and organizational culture. International journal of health care quality assurance, v. 28, n. 8, p. 855-863, 2015.
KUMAR, V; VERMA, P; MUTHUKUMAAR, V. The performances of process capability indices in the Six Sigma competitiveness levels. In: Proceedings of the International Conference on Industrial Engineering and Operations Management. 2018. p. 1945-1951.
KWAK, Young Hoon; ANBARI, Frank T. Benefits, obstacles, and future of six sigma approach. Technovation, v. 26, n. 5-6, p. 708-715, 2006.
LÓPEZ, M G; ROCA, N R; VELASCO, M S; ALCAIDE MARTÍN, M J; SOTO, A B, RIOJA, R G. Estabilidade da lactato desidrogenase no plasma em diferentes temperaturas: armazenamento pós-analítico. Advances in Laboratory Medicine/Avances en Medicina de Laboratorio , v. 4, pág. 20200077, 2020.
MAGNETTE, A; CHATELAIN, M; CHATELAIN, B; TEN CATE, H; MULLIER, F. Pre-analytical issues in the haemostasis laboratory: guidance for the clinical laboratories. Thrombosis journal, v. 14, p. 1-14, 2016.
NANDA, S K; RAY, L. Quantitative application of sigma metrics in medical biochemistry. Journal of clinical and diagnostic research: JCDR, v. 7, n. 12, p. 2689, 2013.
PARDIYONO, R; INDRAYANI, R. Product Quality Control with Six Sigma and Preventive Maintenance. In: Journal of Physics: Conference Series. IOP Publishing, 2020. p. 052046.
RAHMAN, A; SHAJU, S U C; SARKAR, S K; MOHAMMAD, Z; HASAN, S M K; ISLAM, U. The detection and prevention of errors in laboratory medicine. Annals of clinical biochemistry, v. 47, n. 2, p. 101-110, 2010.
PRADHAN, S; GAUTAM, K; PANT, V. ISO 15189: 2022; what’s new in new. J Pathol Nep, v. 13, n. 1, p. 2027-8, 2023.
RAHMAN, A; SHAJU, S U C; SARKAR, S K; MOHAMMAD, Z; HASAN, S M K; ISLAM, U. RAHMAN, Abdur et al. Application of six sigma using define measure analyze improve control (DMAIC) methodology in garment sector. Independent Journal of Management & Production, v. 9, n. 3, p. 810-826, 2018.
RODRIGUES, B. G. Desenho da estratégia de implantação do Seis Sigma em um laboratório clínico. 2014. 75 f., il. Monografia (Bacharelado em Engenharia de Produção)—Universidade de Brasília, Brasília, 2014.
SAPORITO, A. Six Sigma can significantly reduce costs of poor quality of the surgical instruments sterilization process and improve surgeon and operating room personnel satisfaction. Scientific Reports, v. 13, n. 1, p. 14116, 2023.
SILVER, S A. How to begin a quality improvement project. Clinical journal of the American Society of Nephrology: CJASN, v. 11, n. 5, p. 893, 2016.
SNEE, R D. Use DMAIC to make improvement part of “the way we work.”. Quality Progress, v. 40, n. 9, p. 52-54, 2007.
SOKOVIC, M; PAVLETIC, D; PIPAN, K K. Quality improvement methodologies–PDCA cycle, RADAR matrix, DMAIC and DFSS. Journal of achievements in materials and manufacturing engineering, v. 43, n. 1, p. 476-483, 2010.
STURGEON, C M.; VILJOEN, A. Analytical error and interference in immunoassay: minimizing risk. Annals of Clinical Biochemistry, v. 48, n. 5, p. 418-432, 2011.
THAKUR, V. Uso de uma abordagem Lean Six Sigma para investigar o uso excessivo de materiais de controle de qualidade (CQ) e os custos resultantes. Bioquímica Clínica , v. 112, p. 53-60, 2023.
TESHOME, M; WOREDE, A; ASMELASH, D. Total clinical chemistry laboratory errors and evaluation of the analytical quality control using sigma metrics for routine clinical chemistry tests. Journal of multidisciplinary healthcare, p. 125-136, 2021.
TRAD, S; MAXIMIANO, A C A. Six sigma: critical success factors for its implementation. Revista de Administração Contemporânea, v. 13, p. 647-662, 2009.
VAN HEERDEN, M; GEORGE, JA, KHOZA, S. The application of sigma metrics in the laboratory to assess quality control processes in South Africa. Afr J Lab Med. 2022.
WESTGARD, S; BAYAT, H; WESTGARD, J O. Analytical Sigma metrics: a review of Six Sigma implementation tools for medical laboratories. Biochemia Medica, v. 28, n. 2, p. 174-185, 2018.
WHITACRE, T. Use DMAIC to enhance your career. Quality Progress, v. 39, n. 6, p. 70, 2006.
ZIMMERMANN, G S; SIQUEIRA, L D; BOHOMOL, E. Lean Six Sigma methodology application in health care settings: an integrative review. Revista Brasileira de Enfermagem, v. 73, 2020.


