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Review Article| Volume 37, ISSUE 1, P97-117, March 2017

Sigma Metrics Across the Total Testing Process

Published:December 22, 2016DOI:https://doi.org/10.1016/j.cll.2016.09.009

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      References

        • Shewhart W.A.
        Economic control of quality of manufactured product.
        D Van Nostrand Company, New York1931
        • Levey S.
        • Jennings E.R.
        The use of control charts in the clinical laboratory.
        J Clin Pathol. 1950; 20: 1059-1066
      1. Westgard JO. QC past, present and future. Available at: https://www.westgard.com/history-and-future-of-qc.htm, Accessed April 15, 2016.

        • Westgard J.O.
        • Groth T.
        • Aronsson T.
        • et al.
        Performance characteristics of rules for internal quality control: probabilities for false rejection and error detection.
        Clin Chem. 1977; 23: 1857-1867
        • Westgard J.O.
        • Barry P.L.
        • Hunt M.R.
        • et al.
        A multi-rule Shewhart chart for quality control in clinical chemistry.
        Clin Chem. 1981; 27: 493-501
        • Westgard J.O.
        Six sigma quality design & control: desirable precision and requisite QC for laboratory measurement processes.
        Westgard QC, Madison (WI)2001
        • Westgard J.O.
        • Westgard S.
        The quality of laboratory testing today: an assessment of σ metrics for analytic quality using performance data from proficiency testing surveys and the CLIA criteria for acceptable performance.
        Am J Clin Pathol. 2006; 125: 343-354
        • Nevalainen D.
        • Berte L.
        • Kraft C.
        • et al.
        Evaluating laboratory performance on quality indicators with six sigma scale.
        Arch Pathol Lab Med. 2000; 124: 516-519
        • Singh B.
        • Goswami B.
        • Gupta V.K.
        • et al.
        Application of sigma metrics for the assessment of quality assurance in clinical biochemistry laboratory in India: a pilot study.
        Indian J Clin Biochem. 2011; 26: 131-135
        • Bonini P.
        • Plebani M.
        • Ceriotti F.
        • et al.
        Errors in laboratory medicine.
        Clin Chem. 2002; 48: 691-698
        • Carraro P.
        • Plebani M.
        Errors in a stat laboratory: types and frequencies 10 years later.
        Clin Chem. 2007; 53: 1338-1342
        • Westgard J.O.
        • Carey R.N.
        • Wold S.
        Criteria for judging precision and accuracy in method development and evaluation.
        Clin Chem. 1974; 20: 825-833
        • Westgard J.O.
        • Seehafer J.J.
        • Barry P.L.
        Allowable imprecision for laboratory tests based on clinical and analytical test outcome criteria.
        Clin Chem. 1994; 40: 1909-1914
        • Chinchilli V.M.
        • Miller W.G.
        Evaluating test methods by estimating total error.
        Clin Chem. 1994; 40: 464-471
        • Westgard J.O.
        Charts of operational process specifications (“OPSpecs charts”) for assessing the precision, accuracy, and quality control needed to satisfy proficiency testing performance criteria.
        Clin Chem. 1992; 38: 1226-1233
        • Lasky F.D.
        • Boser R.B.
        Designing in quality through design control: a manufacturer′s perspective.
        Clin Chem. 1997; 43: 866-872
        • Westgard J.O.
        Six sigma quality design and control.
        2nd edition. Westgard QC, Madison (WI)2006
        • Westgard J.O.
        Six sigma risk analysis; designing analytical QC plans for medical laboratory.
        Westgard QC, Madison (WI)2011
        • Westgard J.O.
        • Westgard S.A.
        Basic quality management systems: essentials for quality management in the medical laboratory.
        Westgard QC, Madison (WI)2014
        • Laposata M.
        • Dighe A.
        “Pre-pre” and “post-post” analytical error: high-incidence patient safety hazards involving the clinical laboratory.
        Clin Chem Lab Med. 2007; 45: 712-719
        • CLSI
        Laboratory quality control based on risk management; approved guideline. CLSI document EP23-A™.
        Clinical and Laboratory Standards Institute, Wayne (PA)2011
      2. CMS memorandum: implementing the individualized quality control plan (IQCP) for Clinical Laboratory Improvement Amendments (CLIA); 2012. Available at: https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/SCLetter12_20-.pdf. Accessed November 11, 2016.

        • Plebani M.
        The CCLM contribution to improvements in quality and patient safety.
        Clin Chem Lab Med. 2013; 51: 39-46
        • Coskun A.
        Six sigma and calculated laboratory tests.
        Clin Chem. 2006; 52: 770-771
        • Tetrault G.
        Evaluating laboratory performance with the six sigma scale.
        Arch Pathol Lab Med. 2000; 124: 1748-1749
        • Westgard J.O.
        Quality control. How labs can apply six sigma principles to quality control planning.
        Clin Lab News. 2006; 32: 10-12
      3. Sigma verification for examination procedures in medical laboratories. Westgard QC, Madison (WI)2014
      4. Charuruks N, Thanudpasa S, Kedsomboon P, et al. Westgard Sigma Verification Program, as a tool to improve laboratory performance. Poster Number B-169, Poster presentation at the 2015 AACC Annual Meeting. Atlanta, GA, July 26–30, 2015.

      5. Charuruks N. Implementation of Westgard Sigma Verification Program. Oral Presentation, the 8th Annual Asia Pacific & Japan Scientific Symposium: turning science into caring. Bali, Indonesia, December 1–3, 2015.

      6. Clinical Chemistry ARCHITECT GAMMA GULTAMYL TRANSFERASE Ref 7D65, 304645/R02, reagent package insert for ARTHITECT c systems. Abbott Laboratories, Abbott Park (IL)2012
        • Hens K.
        • Berth M.
        • Armbruster D.
        • et al.
        Sigma metrics used to assess analytical quality of clinical chemistry assays: importance of the allowable total error (TEa) target.
        Clin Chem Lab Med. 2014; 52: 973-980
      7. Charuruks N, Thanudpasa S, Kedsomboon P, et al. Six sigma clinical laboratory services at Bumrungrad International Hospital, Thailand. Poster Code W109, Poster presentation at the IFCC-EFLM Euro Med Lab Paris 2015 Congress. Paris, June 21–25, 2015.

      8. Kubiak TM. Perusing process performance metrics selecting the right measures for managing processes. Available at: http://asq.org/quality-progress/2009/08/34-per-million/perusing-process-performance-metrics.html. Accessed December 24, 2014.

        • Llopis M.A.
        • Trujillo G.
        • Llovet M.I.
        • et al.
        Quality indicators and specifications for key analytical-extranalytical processes in the clinical laboratory. Five years’ experience using the Six Sigma concept.
        Clin Chem Lab Med. 2011; 49: 463-470
        • Revere L.
        • Black K.
        Integrating Six Sigma with total quality management; a case example for measuring medication errors.
        J Healthc Manag. 2003; 48: 377-391
        • Fraser C.G.
        General strategies to set quality specifications for reliability performance characteristics.
        Scand J Clin Lab Invest. 1999; 59: 487-490
        • Woodworth A.
        • Korpi-Steiner N.
        • Miller J.J.
        • et al.
        Utilization of assay performance characteristics to estimate hemoglobin A1c result reliability.
        Clin Chem. 2014; 60: 1073-1079
      9. CLIA Brochure #13 CLIA Individualized Quality Control Plan. What is an IQCP? November 2014. Available at: https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/CLIAbrochure13.pdf. Accessed November 11, 2016.

        • McDermott R.E.
        • Mikulak R.J.
        • Beauregard M.R.
        The basics of FMEA.
        2nd edition. CRC Press, New York2009
        • Westgard S.
        Prioritizing risk analysis quality control plans based on sigma metrics.
        Clin Lab Med. 2013; 33 ([In: Westgard JO, Westgard S. Ed., Clinics in laboratory medicine: quality control in the age of risk management]): 41-53
        • Westgard J.O.
        Perspectives on quality control, risk management, and analytical quality management.
        Clin Lab Med. 2013; 33: 1-14