Klinik Laboratuvarlarda Altı Sigma Yaklaşımı

Plebani M, Laposata M, Lippi G. A manifesto for the future of laboratory medicine professionals. Clin Chim Acta. 2019;489:49–52. doi: 10.1016/j.cca.2018.11.021

Sciacovelli L, Lippi G, Sumarac Z, et al. Quality Indicators in Laboratory Medicine: the status of the progress of IFCC Working Group “Laboratory Errors and Patient Safety” project. Clin Chem Lab Med. 2017;55(3): 348-357. doi: 10.1515/cclm-2016-0929

Lundberg GD. Acting on Significant Laboratory Results. JAMA. 1981;245(17):1762–3. doi: 10.1001/jama.1981.03310420052033

Plebani M. Errors in clinical laboratories or errors in laboratory medicine? Clin Chem Lab Med. 2006;44(6): 750-759. doi: 10.1515/CCLM.2006.123

Stankovic AK. The laboratory is a key partner in assuring patient safety. Clin Lab Med. 2004;24(4):1023–35. doi: 10.1016/j.cll.2004.05.017

ISO 15189:2022. Medical laboratories — Requirements for quality and competence. Geneva: International Organization for Standardization (ISO), 2022.

Njoroge SW, Nichols JH. Risk Management in the Clinical Laboratory. Ann Lab Med. 2014;34(4):274–8. doi: 10.3343/alm.2014.34.4.274

CLSI. Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions. 4th ed. CLSI guideline C24. Wayne, PA: Clinical and Laboratory Standards Institute; 2016.

Chassin MR. Is Health Care Ready for Six Sigma Quality? Milbank Q. 1998;76(4):565–91. doi: 10.1111/1468-0009.00106

Brussee Warren. Statistics for Six Sigma made easy! New York: McGraw-Hill; 2004.

Oosterhuis WP, Coskun A. Sigma metrics in laboratory medicine revisited: We are on the right road with the wrong map. Biochem Med. 2018;28(2):020503. doi: 10.11613/BM.2018.020503

Coskun A, Serteser M, Ünsal I. Sigma metric revisited: True known mistakes. Biochem Med. 2019;29(1):142–8. doi: 10.11613/BM.2019.010902

Harry M, Schroeder R. Six Sigma, the breakthrough management strategy revolutionizing the world’s top corporations. New York: Currency;2005

Westgard S, Bayat H, Westgard JO. Analytical Sigma metrics: A review of Six Sigma implementation tools for medical laboratories. Biochem Medica. 2018;28(2):020502. doi: 10.11613/BM.2018.020502

Coskun A, Serteser M, Kilercik M, et al. A new approach to calculating the Sigma Metric in clinical laboratories. Accreditation Qual Assur. 2015;20(2):147–52. doi: 10.1007/s00769-015-1113-8

Psychogios AG, Tsironis LK. Towards an integrated framework for Lean Six Sigma application: Lessons from the airline industry. Total Qual Manag Bus Excell. 2012 1;23(3–4):397–415. doi: 10.1080/14783363.2011.637787

Hoefsmit PC, Schretlen S, Burchell G, et al. Can Quality Improvement Methodologies Derived from Manufacturing Industry Improve Care in Cardiac Surgery? A Systematic Review. J Clin Med. 2022;11(18):5350. doi: 10.3390/jcm11185350

Tlapa D, Tortorella G, Fogliatto F, et al. Effects of Lean Interventions Supported by Digital Technologies on Healthcare Services: A Systematic Review. Int J Environ Res Public Health. 2022;19(15):9018. doi: 10.3390/ijerph19159018

Wackers E, Stadhouders N, Heil A, et al. Hospitals Bending the Cost Curve With Increased Quality: A Scoping Review Into Integrated Hospital Strategies. Int J Health Policy Manag. 2021;1. doi: 10.34172/ijhpm.2021.168

Nevalainen D, Berte L, Kraft C, et al. Evaluating Laboratory Performance on Quality Indicators With the Six Sigma Scale. Arch Pathol Lab Med. 2000;124(4):516–9. doi: 10.5858/2000-124-0516-ELPOQI

Westgard JO. Six Sigma: Quality Design and Control Processes. http://www.westgard.com/lesson67.htm [Accessed at: 15 June 2023].

2024 CLIA Proposed Acceptance Limits for Proficiency Testing. https://www.westgard.com/2024-clia-requirements.htm. [Accessed at 25 June 2023].

Aarsand AK, Fernandez-Calle P, Webster C, Coskun A, Gonzales-Lao E, Diaz-Garzon J, Jonker N, Simon M, Braga F, Perich C, Boned B, Marques-Garcia F, Carobene A, Aslan B, Sezer E, Bartlett WA, Sandberg S. The EFLM Biological Variation Database. https://biologicalvariation.eu/ [Accessed at: 25 June 2023].

Wauthier L, Di Chiaro L, Favresse J. Sigma metrics in laboratory medicine: A call for harmonization. Clin Chim Acta. 2022;532:13–20. doi: 10.1016/j.cca.2022.05.012

Keleş M. Evaluation of the clinical chemistry tests analytical performance with Sigma Metric by using different quality specifications - Comparison of analyser actual performance with manufacturer data. Biochem Medica. 2022;32(1):39–50. doi: 10.11613/BM.2022.010703

Westgard JO, Westgard SA. Total analytic error. From concept to application. https://www.aacc.org/cln/articles/2013/september/total-analytic-error [Accessed at: 27 June 2023].

Westgard JO, Bayat H, Westgard SA. Advanced QC Strategies Risk-Based Design for Medical Laboratories. 1st Edition. Madison WI: Westgard QC, Inc. 2000.

Westgard JO, Westgard SA. Quality control review: implementing a scientifically based quality control system. Annals of Clinical Biochemistry. 2016;53(1):32-50. doi:10.1177/0004563215597248

Westgard JO, Bayat H, Westgard SA. Planning Risk-Based SQC Schedules for Bracketed Operation of Continuous Production Analyzers. Clin Chem. 2018;64(2):289–96. doi: 10.1373/clinchem.2017.278291

Lippi G, editor. Hemolysis: an unresolved dispute in laboratory medicine. Berlin: De Gruyter; 2012.

Oosterhuis WP, Severens MJ. Performance specifications and six sigma theory: Clinical chemistry and industry compared. Clin Biochem. 2018;57:12–7. doi: 10.1016/j.clinbiochem.2018.04.002

Badrick T. Biological variation: Understanding why it is so important? Pract Lab Med. 2021;23:e00199. doi: 10.1016/j.plabm.2020.e00199

Plebani M, Laposata M, Lippi G. A manifesto for the future of laboratory medicine professionals. Clin Chim Acta. 2019;489:49–52. doi: 10.1016/j.cca.2018.11.021

Sciacovelli L, Lippi G, Sumarac Z, et al. Quality Indicators in Laboratory Medicine: the status of the progress of IFCC Working Group “Laboratory Errors and Patient Safety” project. Clin Chem Lab Med. 2017;55(3): 348-357. doi: 10.1515/cclm-2016-0929

Lundberg GD. Acting on Significant Laboratory Results. JAMA. 1981;245(17):1762–3. doi: 10.1001/jama.1981.03310420052033

Plebani M. Errors in clinical laboratories or errors in laboratory medicine? Clin Chem Lab Med. 2006;44(6): 750-759. doi: 10.1515/CCLM.2006.123

Stankovic AK. The laboratory is a key partner in assuring patient safety. Clin Lab Med. 2004;24(4):1023–35. doi: 10.1016/j.cll.2004.05.017

ISO 15189:2022. Medical laboratories — Requirements for quality and competence. Geneva: International Organization for Standardization (ISO), 2022.

Njoroge SW, Nichols JH. Risk Management in the Clinical Laboratory. Ann Lab Med. 2014;34(4):274–8. doi: 10.3343/alm.2014.34.4.274

CLSI. Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions. 4th ed. CLSI guideline C24. Wayne, PA: Clinical and Laboratory Standards Institute; 2016.

Chassin MR. Is Health Care Ready for Six Sigma Quality? Milbank Q. 1998;76(4):565–91. doi: 10.1111/1468-0009.00106

Brussee Warren. Statistics for Six Sigma made easy! New York: McGraw-Hill; 2004.

Oosterhuis WP, Coskun A. Sigma metrics in laboratory medicine revisited: We are on the right road with the wrong map. Biochem Med. 2018;28(2):020503. doi: 10.11613/BM.2018.020503

Coskun A, Serteser M, Ünsal I. Sigma metric revisited: True known mistakes. Biochem Med. 2019;29(1):142–8. doi: 10.11613/BM.2019.010902

Harry M, Schroeder R. Six Sigma, the breakthrough management strategy revolutionizing the world’s top corporations. New York: Currency;2005

Westgard S, Bayat H, Westgard JO. Analytical Sigma metrics: A review of Six Sigma implementation tools for medical laboratories. Biochem Medica. 2018;28(2):020502. doi: 10.11613/BM.2018.020502

Coskun A, Serteser M, Kilercik M, et al. A new approach to calculating the Sigma Metric in clinical laboratories. Accreditation Qual Assur. 2015;20(2):147–52. doi: 10.1007/s00769-015-1113-8

Psychogios AG, Tsironis LK. Towards an integrated framework for Lean Six Sigma application: Lessons from the airline industry. Total Qual Manag Bus Excell. 2012 1;23(3–4):397–415. doi: 10.1080/14783363.2011.637787

Hoefsmit PC, Schretlen S, Burchell G, et al. Can Quality Improvement Methodologies Derived from Manufacturing Industry Improve Care in Cardiac Surgery? A Systematic Review. J Clin Med. 2022;11(18):5350. doi: 10.3390/jcm11185350

Tlapa D, Tortorella G, Fogliatto F, et al. Effects of Lean Interventions Supported by Digital Technologies on Healthcare Services: A Systematic Review. Int J Environ Res Public Health. 2022;19(15):9018. doi: 10.3390/ijerph19159018

Wackers E, Stadhouders N, Heil A, et al. Hospitals Bending the Cost Curve With Increased Quality: A Scoping Review Into Integrated Hospital Strategies. Int J Health Policy Manag. 2021;1. doi: 10.34172/ijhpm.2021.168

Nevalainen D, Berte L, Kraft C, et al. Evaluating Laboratory Performance on Quality Indicators With the Six Sigma Scale. Arch Pathol Lab Med. 2000;124(4):516–9. doi: 10.5858/2000-124-0516-ELPOQI

Westgard JO. Six Sigma: Quality Design and Control Processes. http://www.westgard.com/lesson67.htm [Accessed at: 15 June 2023].

2024 CLIA Proposed Acceptance Limits for Proficiency Testing. https://www.westgard.com/2024-clia-requirements.htm. [Accessed at 25 June 2023].

Aarsand AK, Fernandez-Calle P, Webster C, Coskun A, Gonzales-Lao E, Diaz-Garzon J, Jonker N, Simon M, Braga F, Perich C, Boned B, Marques-Garcia F, Carobene A, Aslan B, Sezer E, Bartlett WA, Sandberg S. The EFLM Biological Variation Database. https://biologicalvariation.eu/ [Accessed at: 25 June 2023].

Wauthier L, Di Chiaro L, Favresse J. Sigma metrics in laboratory medicine: A call for harmonization. Clin Chim Acta. 2022;532:13–20. doi: 10.1016/j.cca.2022.05.012

Keleş M. Evaluation of the clinical chemistry tests analytical performance with Sigma Metric by using different quality specifications - Comparison of analyser actual performance with manufacturer data. Biochem Medica. 2022;32(1):39–50. doi: 10.11613/BM.2022.010703

Westgard JO, Westgard SA. Total analytic error. From concept to application. https://www.aacc.org/cln/articles/2013/september/total-analytic-error [Accessed at: 27 June 2023].

Westgard JO, Bayat H, Westgard SA. Advanced QC Strategies Risk-Based Design for Medical Laboratories. 1st Edition. Madison WI: Westgard QC, Inc. 2000.

Westgard JO, Westgard SA. Quality control review: implementing a scientifically based quality control system. Annals of Clinical Biochemistry. 2016;53(1):32-50. doi:10.1177/0004563215597248

Westgard JO, Bayat H, Westgard SA. Planning Risk-Based SQC Schedules for Bracketed Operation of Continuous Production Analyzers. Clin Chem. 2018;64(2):289–96. doi: 10.1373/clinchem.2017.278291

Lippi G, editor. Hemolysis: an unresolved dispute in laboratory medicine. Berlin: De Gruyter; 2012.

Oosterhuis WP, Severens MJ. Performance specifications and six sigma theory: Clinical chemistry and industry compared. Clin Biochem. 2018;57:12–7. doi: 10.1016/j.clinbiochem.2018.04.002

Badrick T. Biological variation: Understanding why it is so important? Pract Lab Med. 2021;23:e00199. doi: 10.1016/j.plabm.2020.e00199