Utilizing global data to estimate analytical performance on the Sigma scale: A global comparative analysis of methods, instruments, and manufacturers through external quality assurance and proficiency testing programs

Clinical Biochemistry

Volumn 49, Issue 9, 2016, Pages 699-707

  Westgard, Sten A ^a  

^a Westgard QC Inc   (United States)

Author keywords

Chemistry; External quality assessment; Instrument performance; Proficiency testing; Quality; Sigma metrics; Six sigma

Indexed keywords

ALBUMIN; GLUCOSE; LANTHANUM; SODIUM; PLASMA PROTEIN;

ANALYTICAL EQUIPMENT; ARTICLE; CANADIAN; CHEMOMETRICS; COMPARATIVE STUDY; DECISION MAKING; ELECTRICAL EQUIPMENT; GENERAL DEVICE; GLOBAL POSITIONING SYSTEM; IMMUNOASSAY; IMMUNOASSAY ANALYZER; LABORATORY TEST; METRIC SYSTEM; PERFORMANCE; PRIORITY JOURNAL; QUALITY CONTROL; RELIABILITY; UNITED KINGDOM; GOOD LABORATORY PRACTICE; HEALTH CARE QUALITY; HUMAN; LABORATORY; PROCEDURES; STANDARD; STANDARDS; STATISTICAL BIAS;

BIAS (EPIDEMIOLOGY); BLOOD PROTEINS; HUMANS; LABORATORIES; LABORATORY PROFICIENCY TESTING; QUALITY ASSURANCE, HEALTH CARE; QUALITY CONTROL; REFERENCE STANDARDS;

EID: 84960981538     PISSN: 00099120     EISSN: 18732933     Source Type: Journal    
DOI: 10.1016/j.clinbiochem.2016.02.013     Document Type: Article

References (32)

1. ISO 15189 Medical laboratories - requirements for quality and competence 2012, ISO, Geneva.
2. US Centers for Medicare & Medicaid Services (CMS) Medicare, Medicaid, and CLIA Programs: laboratory requirements relating to quality systems and certain personnel qualifications. Final rule. Fed. Regist. Jan 24, 2003, 16:3650-3714.
3. Westgard J.O., Westgard S.A. Quality control review: implementing a scientifically based quality control system. Ann. Clin. Biochem. 2016, 53:32-50.
4. Westgard S. Prioritizing risk analysis quality control plans based on Sigma-metrics. Clin. Lab. Med. 2013, 33:41-53.
5. Schoenmarkers C.H.H., Naus A.J.M., Vermeer H.J., et al. Practical application of sigma metrics QC procedures in clinical chemistry. Clin. Chem. Lab. Med. 2011, 49:1837-1843.
6. Zhang C., Zhao H., Wang J., Zeng J., Wang Z. The application of six sigma techniques in the evaluation of enzyme measurement procedures in China. Clin. Lab. 2015, 16:461-465.
7. Marques-Garcia F., Carcia-Codesal M.F., Caro-Narros M.R., Contreras-SanFeliciano T. Importance of implementing an analytical quality control system in a core laboratory. Rev. Calid. Asist. 2015, 30:302-309.
8. Fei Y., Wang W., He F., Zhong K., Wang Z. Evaluating performance on point-of-care testing with six Sigma metric for 151 institutions in China. Diabetes Technol. Ther. 2015, 17:745-754.
9. Huysal K., Budak Y.U. Application of sigma metrics for the assessment of quality assurance using the MQ-2000 PT HbA1c analyzer. Biochem. Med. (Zagreb) 2015, 25:416-420.
10. Hens K., Berth M., Armbruster D., Westgard S. 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.
11. Afrifa J., Gyekye S.A., Owiredu W.K.B.A., Ephraim R.K.D., Essien-Baidoo S., Amoah S., Simpong D.L., Arthur A.R. Application of sigma metrics for the assessment of quality control in clinical chemistry laboratory in Ghana: a pilot study. Niger. Med. J. 2015, 56:54-58.
12. Risk M.M., Zaki A., Hossam N., Aboul-Ela Y. Evaluating laboratory key performance using quality indicators in Alexandria University Hospital Clinical Chemistry laboratories. J. Egypt. Public Health Assoc. 2014, 89:105-113.
13. Singh B., Goswami B., Gupta V.K., Chawla R., Mallika V. 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.
14. Lakshman M., Reddy B.R., Bhulaxmi P., Malathi K., Salma M., Prakasham S. Evaluation of Sigma metrics in a medical biochemistry lab. Int. J. Biomed. Res. 2015, 6:164-171.
15. Jones G., Celleja J., Chesher D., Parvin C., Yundt-Pacheco J., Mackay M., Badrick T. Collective opinion paper on a 2013 AACB workshop of experts seeking harmonisation of approaches to setting a laboratory quality control policy. Clin. Biochem. Rev. 2015, 36:87-95.
16. CLSI C24 A3 Statistical quality control for quantitative measurement procedures: principles and definitions 2006.
17. Weykamp C., John G., Gillery P., et al. Investigation of 2 models to set and evaluate quality targets for HbA1c: biological variation and sigma-metrics. Clin. Chem. 2015, 61:752-759.
18. Westgard J.O., Westgard S.A. 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.
19. Jassam N., Yundt-Pahcheco J., Jansen R., Thomas A., Barth J.H. Can current analytical quality performance of UK clinical laboratories support evidence-based guidelines for diabetes and ischaemic heart disease? - a pilot study and proposal. Clin. Chem. Lab. Med. 2013, 51:1579-1584.
20. Westgard J.O., Westgard S.A. Assessing quality on the sigma scale from proficiency testing and external quality assessment surveys. Clin. Chem. Lab. Med. 2015, 53:1531-1535.
21. Sciacovelli L., Secchiero S., Zardo L., Plebani M. The role of external quality assessment. Biochem. Med. 2010, 20:160-164.
22. Ricos C., Baadenhuijsen H., Libeer C.J., Petersen P.H., Stokl D., Thienpont L., et al. External quality assessment: currently used criteria for evaluating performance in European countries, and criteria for future harmonization. Eur. J. Clin. Chem. Clin. Biochem. 1996, 34:159-165.
23. Friedecky B., Kratochvila J., Budina M. Why do different EQA schemes have apparently different limits of acceptability?. Clin. Chem. Lab. Med. 2011, 49:743-745.
24. Jones G.R.D. Analytical performance specifications for EQA schemes - need for harmonization. Clin. Chem. Lab. Med. 2015, 53:919-924.
25. CLIA Proficiency Testing Criteria Fed. Regist. February 28, 1992, 57(40):7002-7186. (See also www.westgard.com/clia.htm).
26. Ricos C., Alvarez V., Cava F., Garcia-Lario J.V., Hernandez A., Jimenez C.V., Minchinela J., Perich C., M.Simon Current databases on biologic variation: pros, cons and progress. Scand. J. Clin. Lab. Invest. 1999, 59:491-500. (See also www.westgard.com/biodatabase1.htm.
27. Miller W.G., Jones G.R., Horowitz G.L., Weykamp C. Proficiency testing/external quality assessment: current challenges and future directions. Clin. Chem. 2011, 51:1670-1680.
28. 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.
29. Westgard J.O., Burnett R.W. Precision requirements for cost-effective operation of analytical processes. Clin. Chem. 1990, 36:1629-1632.
30. Burnett L. Equivalence of critical error calculations and process capability index Cpk, letters. Clin. Chem. 1997, 43:1100-1101.
31. Coskun A., Serteser J., Kilercik M., et al. A new approach to calculating the Sigma Metric in clinical laboratories. Accred. Qual. Assur. 2015, 20:147-152.
32. Cooper G., DeJong N., Ehrmeyer S., Yundt-Pacheco J., Jansen R., Ricos C., Plebani M. Collective opinion paper on findings of the 2010 convocation of experts on laboratory quality. Clin. Chem. Lab. Med. 2011, 49:793-802.