Application of Sigma Metrics for Evaluating Analytical Performance of HbA1C Testing on D10- HbA1C Analyzer

Authors

  • Bibek Pun Magar Department of Biochemistry, Karnali academy of Health and Sciences
  • Amit Thapa Province Public Health Laboratory, Karnali Province Surkhet, Nepal
  • Shreeman Acharya Rapti Academy of Health Sciences, Ghorahi, Dang, Nepal
  • Narayan Ghimire School of Health and Allied Sciences, Pokhara University, Pokhara, Nepal
  • Sanjiv Kumar Pandey Nepal Pharmacy Council, Kathmandu, Nepal
  • Rabindra Kumar Rokaya School of Pharmacy, Karnali Academy of Health Sciences, Jumla,Nepal
  • Suman Lamichhane Shree Medical and Technical College, Bharatpur, Nepal (Purvanchal University, Nepal)

Abstract

In this study, analyzed HbA1C over a period of 6 months. Six Sigma improves the quality of process outputs by analyzing and eliminating the source of defects and reducing variability in manufacturing and business practices. In terms of clinical laboratory, the identification of test with low Sigma values (< 3σ) indicate that actions should be taken to improve analytic quality or the laboratory should use alternate methods and reagents. Our study showed methodologies for HbA1C is of world class performance achieving Sigma value ˃6, to maintain and improve this frequency of QC should be run as rule as per the westguard QC rule. Sigma metrics helps to assess analytical methodologies and augment laboratory performance. It acts as a guide for planning quality control strategy. It can be a self -assessment tool regarding the functioning of clinical laboratory. Using Six Sigma techniques, able to identify problem areas as well as recurring issues that affect the overall quality expectation of laboratory result.

Keywords: HbA1C, Six Sigma, Six Sigma values

Keywords:

HbA1C, six sigma, sigma values

DOI

https://doi.org/10.22270/jddt.v14i4.6424

Author Biographies

Bibek Pun Magar, Department of Biochemistry, Karnali academy of Health and Sciences

Department of Biochemistry, Karnali Academy of Health Sciences, Jumla, Nepal

Amit Thapa, Province Public Health Laboratory, Karnali Province Surkhet, Nepal

Province Public Health Laboratory, Karnali Province Surkhet, Nepal

Shreeman Acharya, Rapti Academy of Health Sciences, Ghorahi, Dang, Nepal

Rapti Academy of Health Sciences, Ghorahi, Dang, Nepal

Narayan Ghimire, School of Health and Allied Sciences, Pokhara University, Pokhara, Nepal

School of Health and Allied Sciences, Pokhara University, Pokhara, Nepal

Sanjiv Kumar Pandey, Nepal Pharmacy Council, Kathmandu, Nepal

Nepal Pharmacy Council, Kathmandu, Nepal

Rabindra Kumar Rokaya, School of Pharmacy, Karnali Academy of Health Sciences, Jumla,Nepal

School of Pharmacy, Karnali Academy of Health Sciences, Jumla,Nepal

Suman Lamichhane, Shree Medical and Technical College, Bharatpur, Nepal (Purvanchal University, Nepal)

Shree Medical and Technical College, Bharatpur, Nepal (Purvanchal University, Nepal)  

References

Schroeder RG, Linderman K, Liedtke C, Choo AS,Six Sigma: Definition and underlying theory Journal of Operations Management. 2008; 26: 536-554. https://doi.org/10.1016/j.jom.2007.06.007

Nevalainen D, Berte L, Kraft C, Leigh E, Picaso L, Morgan T. Evaluating laboratory performance on quality indicators withSix Sigma scale. Arch Pathol Lab Med. 2000;124(4): 516-9. 5 https://doi.org/10.5858/2000-124-0516-ELPOQI PMid:10747306

Coskun A.Six Sigma and calculated laboratory tests. Clin Chem. 2006;52:770-1 https://doi.org/10.1373/clinchem.2005.064311 PMid:16595831

Aslan D, Demir S. Laboratuvar Tıbbında Altı Sigma Kalite Yönetimi. Turk J Biochem 2005;30:272-278.

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. https://doi.org/10.1515/cclm-2013-1090 PMid:24615486

Syahputri, K., R. M. Sari, Anizar, I. R. Tarigan, and I. Siregar. 2018. "Application of LeanSix Sigma to Waste Minimization in Cigarette Paper Industry." IOP Conference Series: Materials Science and Engineering. 2018; 309(012027). https://doi.org/10.1088/1757-899X/309/1/012027

Sirajuddin, T. Yuri Zagloel, and S. Rauf. 2016. "Improving Indonesian Logistics Performance with UsingSix Sigma, DMAIC and Integration Process." Pp. 2857-58 in Vols. 8-10 March. Department of Industrial Engineering, Enginering Faculty, Indonesia Universit, Kampus UI Depok16424, Indonesia: IEOM Society

Dr. U. Satyanarayana, Dr. U. Chakrapani: Biochemistry; 4th edition; 2013

Radin MS. Pitfalls in Hemoglobin A1c Measurement: When Results may be Misleading. J Gen Intern Med 2014;29:388-394. https://doi.org/10.1007/s11606-013-2595-x PMid:24002631 PMCid:PMC3912281

Tekce BK, Tekce H, Aktaş G, Tosun M. Comparing the HbA1c Assay Results of Architect C 8000 and MQ-2000PT. Jarem 2015;5:52-55. https://doi.org/10.5152/jarem.2015.684

Goodall I, Colman PG, Schneider HG, McLean M, Barker G. Desirable performance standards for HbA1c analysis - precision, accuracy and standardisation: consensus statement of the Australasian Association of Clinical Biochemists (AACB), the Australian Diabetes Society (ADS), the Royal College of Pathologists of Australasia (RCPA), Endocrine Society of Australia (ESA), and the Australian Diabetes Educators Association (ADEA). Clin Chem Lab Med 2007;45:1083-1097 https://doi.org/10.1515/CCLM.2007.158 PMid:17579563

Sacks DB. Measurement of hemoglobin A1c: a new twist on the path to harmony. Diabetes Care 2012;35:2674-2680 https://doi.org/10.2337/dc12-1348 PMid:23173136 PMCid:PMC3507560

Sandberg S, Fraser CG, Horvath AR, et al. Defining analytical performance specifications: Consensus Statement from the 1st Strategic Conference of the European Federation of Clinical Chemistry and Laboratory Medicine. Clin Chem Lab Med. 2015;53: 833-835. https://doi.org/10.1515/cclm-2015-0067 PMid:25719329

Njoroge SW, Nichols JH. Risk management in the clinical laboratory. Ann Lab Med. 2014;34:274-278.https://doi.org/10.3343/alm.2014.34.4.274 PMid:24982831 PMCid:PMC4071183

Njoroge SW, Nichols JH. Risk management in the clinical laboratory. Ann Lab Med. 2014;34:274-278. https://doi.org/10.3343/alm.2014.34.4.274 PMid:24982831 PMCid:PMC4071183

Sandberg S, Fraser CG, Horvath AR, Jansen R, Jones G, Oosterhuis W, et al .Defining analytical performance specifications: Consensus statement from the 1st strategic conference of the European Federation of Clinical Chemistry and Laboratory Medicine . Clin Chem Lab Med 2015;53:833-5 . http://dx .doi .org/10 .1515/cclm-2015- 0067 . https://doi.org/10.1515/cclm-2015-0067

Njoroge SW, Nichols JH . Risk management in the clinical laboratory . Ann Lab Med 2014;34:274-8 . http://dx .doi . org/10 .3343/alm .2014 .34 .4 .274 . https://doi.org/10.3343/alm.2014.34.4.274 PMid:24982831 PMCid:PMC4071183

Nevalainen D, Berte L, Kraft C, Leigh E, Picaso L, Morgan T. Evaluating laboratory performance on quality indicators withSix Sigma scale. Arch Pathol Lab Med. 2000;124(4):516-9. https://doi.org/10.5858/2000-124-0516-ELPOQI PMid:10747306

Westgard JO.Six Sigma quality design and control, 2nd ed. Madison WI: Westgard QC Inc., 2006;338.

Brussee W. Statistics forSix Sigma made easy. New York: McGraw-Hill 2004;229.

James O. Westgard, Sten A. Westgard. The Quality of Laboratory Testing Today: An Assessment of Sigma 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. https://doi.org/10.1309/V50H4FRVVWX12C79

Westgard JO: 2006, Quality control. How labs can applySix Sigma principles to quality control planning. Clin Lab News 32:10-12.

Coskun A, Inal T, Unsal I, et al.Six Sigma as a quality management tool: evaluation of performance in laboratory medicine. Quality Management andSix Sigma 2010. ISBN: 978-953-307-130-5. https://doi.org/10.5772/9928

Westgard JO, Westgard SA. The quality of laboratory testing today: an assessment of Sigma metrics for analytic quality using performance data from proficiency testing surveys and the CLIA criteria for acceptable performance. Am J Clin Pathol 2006;125(3):343-54. https://doi.org/10.1309/V50H4FRVVWX12C79 PMid:16613337

Little RR, Rohlfing CL, Sacks DB. Status of hemoglobin A1c measurement and goals for improvement: from chaos to order for improving diabetes care. Clin Chem 2011; 57: 205-14. https://doi.org/10.1373/clinchem.2010.148841 PMid:21148304

Weykamp C. HbA1c: a review of analytical and clinical aspects. Ann Lab Med 2013; 33: 393-400 https://doi.org/10.3343/alm.2013.33.6.393 PMid:24205486 PMCid:PMC3819436

Woodworth A, Korpi-Steiner N, Miller JJ, Rao LV, YundtPacheco J, Kuchipudi L, et al. Utilization of assay performance characteristics to estimate hemoglobin A1c result reliability. Clin Chem 2014; 60: 1073-9. https://doi.org/10.1373/clinchem.2013.220772 PMid:24815907

Westgard JO, Westgard SA. Assessing quality on the Sigma scale from proficiency testing and external quality assessment surveys. Clin Chem Lab Med 2015; 53: 1531-5. https://doi.org/10.1515/cclm-2014-1241

. Weykamp C, John G, Gillery P, English E, Ji L, LentersWestra E, et al. Investigation of 2 models to set and evaluate quality targets for HbA1c: biological variation and Sigma-metrics. Clin Chem 2015; 61: 752-9. https://doi.org/10.1373/clinchem.2014.235333 PMid:25737535 PMCid:PMC4946649

Farr AJ, Freeman KP. Quality control validation, application of Sigma metrics, and performance comparison between two biochemistry analysers in a commercial veterinary laboratory. J Vet Diagn Invest 2008;20(5):536-44. https://doi.org/10.1177/104063870802000502 PMid:18776084

Ricos C, Alvarez V, Cava F, et al. Current databases on biological variation: pros, cons and progress. Scand J Clin Lab Invest 1999;59(7):491-500. This database was most recently updated in 2014 https://doi.org/10.1080/00365519950185229 PMid:10667686

Westgard JO, Westgard SA. Quality control review: implementing a scientifically based quality control system. Ann ClinBiochem 2016;53:32-50. https://doi.org/10.1177/0004563215597248 PMid:26150675

Westgard JO.Six Sigma quality design and control. Westgard QC, Inc, Madison.

Tetrault G. Evaluating laboratory performance with theSix Sigma scale. Arch Pathol Lab Med 2000; 124(12):1748-9. https://doi.org/10.5858/2000-124-1748c-ELPWTS PMid:11100045

Westgard JO. Internal quality control: planning and implementation strategies. Ann Clin Biochem 2003; 40:593-611. https://doi.org/10.1258/000456303770367199 PMid:14629798

Berte ML. Laboratory Quality Management: A Road Map. Clin Lab Med 2007;27:771-790. https://doi.org/10.1016/j.cll.2007.07.008 PMid:17950897

Coskun A, editor. Quality Management andSix Sigma. Rijeka, Croatia; 2010. www.sciyo.com https://doi.org/10.5772/271

Lachin JM, Genuth S, Nathan DM, Zinman B, Rutledge BN; DCCT/ EDIC Research Group. Effect of glycemic exposure on the risk of microvascular complications in the diabetes control and complications trial revisited. Diabetes 2008;57:995-1001. https://doi.org/10.2337/db07-1618 PMid:18223010

Little RR, Rothlfing CL, Wiedmeyer H-M, Myers GL, Sacks DB, Goldstein DE. The National Gtycohemoglobin Standardization Program (NGSP): A five-year progress report. Clin Chem 2001;47:1985-1992

Published

15-04-2024
Statistics
Abstract Display: 251
PDF Downloads: 217
PDF Downloads: 39

How to Cite

1.
Magar BP, Thapa A, Acharya S, Ghimire N, Pandey SK, Rokaya RK, et al. Application of Sigma Metrics for Evaluating Analytical Performance of HbA1C Testing on D10- HbA1C Analyzer. J. Drug Delivery Ther. [Internet]. 2024 Apr. 15 [cited 2025 May 13];14(4):27-32. Available from: https://jddtonline.info/index.php/jddt/article/view/6424

How to Cite

1.
Magar BP, Thapa A, Acharya S, Ghimire N, Pandey SK, Rokaya RK, et al. Application of Sigma Metrics for Evaluating Analytical Performance of HbA1C Testing on D10- HbA1C Analyzer. J. Drug Delivery Ther. [Internet]. 2024 Apr. 15 [cited 2025 May 13];14(4):27-32. Available from: https://jddtonline.info/index.php/jddt/article/view/6424

Most read articles by the same author(s)