Ann Lab Med.  2021 Mar;41(2):230-239. 10.3343/alm.2021.41.2.230.

Schemes and Performance Evaluation Criteria of Korean Association of External Quality Assessment (KEQAS) for Improving Laboratory Testing

• Kim S
• Lee K
• Park HD
• Lee YW
• Chun S
• Min WK

• KMID: 2512671
• DOI: http://doi.org/10.3343/alm.2021.41.2.230

Abstract

External quality assessment (EQA) is important for evaluating clinical laboratories and enhancing their testing quality. EQA schemes are variable; thus, it is crucial that the EQA organizers share their experiences to continuously improve the EQA scheme. The Korean Association of External Quality Assessment Service (KEQAS) has been the leading, authorized EQA institute for the standardization and quality management of laboratory testing in Korean medical institutions since 1976. The EQA scheme underwent a major change in 2016, and the number of EQA programs increased significantly since then. The key changes implemented in EQA scheme include a fully computerized assessment to accelerate feedback and unification of the testing and reporting methods. We provide an overview of the EQA schemes and performance evaluation criteria of the KEQAS and suggest directions for achieving the global harmonization of EQA.

Keyword

Korean Association of External Quality Assessment Service (KEQAS); Performance; Evaluation; Laboratory testing; Schemes; Quality; Harmonization

Figure

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  Fig. 1 Flow diagram of performance evaluation for (A) qualitative and (B) semi-quantitative tests in the KEQAS EQA scheme. Abbreviations: KEQAS, Korean Association of External Quality Assessment Service; EQA, external quality assessment.

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  Fig. 2 Examples of the EQA reports of the KEQAS. (A) Participant evaluation report and (B) participants’ summary. Abbreviations: KEQAS, Korean Association of External Quality Assessment Service; EQA, external quality assessment.

Reference

1. Jang MA, Yoon YA, Song J, Kim JH, Min WK, Lee JS, et al. 2017; Effect of accreditation on accuracy of diagnostic in medical laboratories. Ann Lab Med. 37:213–22. DOI: 10.3343/alm.2017.37.3.213. PMID: 28224767. PMCID: PMC5339093.

2. Lee W, Ryoo N, Suh HS, Jeon CH. 2019; Improvement in external quality assessment results for qualitative fecal immunochemical tests in Korea after feedback to manufacturers. Ann Lab Med. 39:584–6. DOI: 10.3343/alm.2019.39.6.584. PMID: 31240889. PMCID: PMC6660328.

3. World Health Organization. 2016. WHO manual for organizing a national external quality assessment programme for health laboratories and other testing sites. WHO Press;Geneva, Switzerland:

4. Ceriotti F, Cobbaert C. 2018; Harmonization of External Quality Assessment Schemes and their role-clinical chemistry and beyond. Clin Chem Lab Med. 56:1587–90. DOI: 10.1515/cclm-2018-0265. PMID: 29715181.

5. Haliassos A. 2018; Inter-laboratory comparisons and EQA in the Mediterranean area. EJIFCC. 29:253–8.

6. Peterson JC, Hill RH, Black RS, Winkelman J, Tholen D. 2008. Review of proficiency testing services for clinical laboratories in the United States-final report of a Technical Working Group. Battelle Memorial Institute; Atlanta, GA:

7. Kim S, Yun YM, Kim H, Um TH, Chang J, Jeong H, et al. 2020; The new diagnosis-related group reimbursement system and laboratory test quality in Korea: analysis of external quality assessment results. Healthcare (Basel). 8:127. DOI: 10.3390/healthcare8020127. PMID: 32392746. PMCID: PMC7349770.

8. Korean Association of External Quality Assessment Service. https://keqas.org/. Updated on Sep 2020.

9. Kim H, Kim S, Yun YM, Um TH, Chang J, Lee KS, et al. 2020; Status of quality control for laboratory tests of medical institutions in Korea: analysis of 10 years of data on external quality assessment participation. Healthcare (Basel). 8:75. DOI: 10.3390/healthcare8020075. PMID: 32230819. PMCID: PMC7349217.

10. Miller WG, Jones GR, Horowitz GL, Weykamp C. 2011; Proficiency testing/external quality assessment: current challenges and future directions. Clin Chem. 57:1670–80. DOI: 10.1373/clinchem.2011.168641. PMID: 21965556.

11. Jeong TD, Lee HA, Lee K, Yun YM. 2019; Accuracy-based proficiency testing of creatinine measurement: 7 years' experience in Korea. J Lab Med Qual Assur. 41:13–23. DOI: 10.15263/jlmqa.2019.41.1.13.

12. Krleza JL, Celap I, Tanaskovic JV. 2017; External Quality Assessment in Croatia: problems, challenges, and specific circumstances. Biochem Med (Zagreb). 27:86–92. DOI: 10.11613/BM.2017.011. PMID: 28392730. PMCID: PMC5382851.

13. Jones GRD, Albarede S, Kesseler D, MacKenzie F, Mammen J, Pedersen M, et al. 2017; Analytical performance specifications for external quality assessment-definitions and descriptions. Clin Chem Lab Med. 55:949–55. DOI: 10.1515/cclm-2017-0151. PMID: 28593915.

14. CLSI. 2016. Using proficiency testing and alternative assessment to improve medical laboratory quality. CLSI QMS24. 3rd ed. Clinical and Laboratory Standards Institute;Wayne, PA:

15. Coucke W, Soumali MR. 2017; Demystifying EQA statistics and reports. Biochem Med (Zagreb). 27:37–48. DOI: 10.11613/BM.2017.006. PMID: 28392725. PMCID: PMC5382862.

16. Lippi G, Chance JJ, Church S, Dazzi P, Fontana R, Giavarina D, et al. 2011; Preanalytical quality improvement: from dream to reality. Clin Chem Lab Med. 49:1113–26. DOI: 10.1515/CCLM.2011.600. PMID: 21517699.

17. Plebani M, Sciacovelli L, Aita A, Padoan A, Chiozza ML. 2014; Quality indicators to detect pre-analytical errors in laboratory testing. Clin Chim Acta. 432:44–8. DOI: 10.1016/j.cca.2013.07.033. PMID: 24012653.

18. Duan M, Kang F, Zhao H, Wang W, Du Y, He F, et al. 2019; Analysis and evaluation of the external quality assessment results of quality indicators in laboratory medicine all over China from 2015 to 2018. Clin Chem Lab Med. 57:812–21. DOI: 10.1515/cclm-2018-0983. PMID: 30511924.

19. Badrick T, Gay S, McCaughey EJ, Georgiou A. 2017; External Quality Assessment beyond the analytical phase: an Australian perspective. Biochem Med (Zagreb). 27:73–80. DOI: 10.11613/BM.2017.009. PMID: 28392728. PMCID: PMC5382854.

20. Bachner P. 2014; Anniversary of Q-Probes and Q-Tracks quality assurance programs. Arch Pathol Lab Med. 138:1139–40. DOI: 10.5858/arpa.2014-0244-ED. PMID: 25171695.