XML Print


1- Assistant Professor, Department of Biochemistry, Shrimati Kashibai Navale Medical College & General Hospital, Narhe, Pune- 411041 Maharashtra, India.
2- Associate Professor, Department of Biochemistry, Shrimati Kashibai Navale Medical College & General Hospital, Narhe, Pune- 411041 Maharashtra, India.
3- Professor & Head, Department of Biochemistry, Shrimati Kashibai Navale Medical College & General Hospital, Narhe, Pune- 411041 Maharashtra, India.
4- Associate Professor, Department of Biochemistry, RKDF Medical College, Hospital and Research Centre, Bhopal-462026, Madhya Pradesh, India , charushila.yuvraj@gmail.com
Abstract:   (465 Views)
Background and Objectives: Quality control (QC) is a crucial tool in the clinical laboratory for error identification and correction. While IQC ensures daily precision and accuracy, EQAS ensures long-term accuracy by providing external verification. The objective of this study was to evaluate our laboratory’s performance in the EQAS program and assess the impact of corrective actions on EQAS performance improvement.
Methods: The retrospective observational study was undertaken in the tertiary care hospital. The Biochemistry department of the laboratory participated in the monthly clinical chemistry EQA program administered by CMC Vellore EQAS. Nineteen parameters were assessed using structured approach to analyze deviating EQAS results. Monthly performance was analyzed in terms of the SDI (Standard Deviation Index) and VIS (variance index score) for the period of October 2019 to September 2021.
Results: Among the nineteen parameters assessed in EQAS program, most showed ‘excellent’ performance between October 2019 and September 2021 based on mean SDI. Some improvement was observed in the SDI values between the two cycles after implementing a structured approach in root cause analysis and indicates an enhanced level of performance in the EQAS program. The VIS analysis revealed that 89.47% of parameters in the October 2019 to September 2020 period and 94.73% in the October 2020 to September 2021 achieved scores classified as ‘very good’ performance.
Conclusion: Adopting a structured approach to analyze deviating EQAS results enables the evaluation of laboratory performance and offers opportunities for improvement. Consequently, EQAS plays a significant role as a cornerstone in the accreditation process.
Full-Text [PDF 454 kb]   (158 Downloads)    
Research Article: Research Article | Subject: Biochemistry
Received: 2023/06/8 | Accepted: 2023/10/9

References
1. Niraula A, BatajuM. External quality assessment practices in clinical biochemistry laboratory: What is the need? Kathmandu Univ. Med. J. 2020; 18(69): 86-92. [View at Publisher] [DOI] [PMID] [Google Scholar]
2. Vesper HW, Miller WG, Myers GL. Reference materials and commutability. Clin Biochem Rev. 2007;28(4):139-147. [View at Publisher] [PMID] [Google Scholar]
3. Jones GR. The role of EQA in harmonization in laboratory medicine - a global effort. Biochem. Med (Zagreb). 2017; 27(1): 23-29. [View at Publisher] [DOI] [PMID] [Google Scholar]
4. Ricos C, Fernández-Calle P, Perich C, Sandberg S. External quality control in laboratory medicine. Progresses and future. Adv Lab Med. 2022; 3(3): 221-231. [View at Publisher] [DOI] [PMID] [Google Scholar]
5. Bhatt RD, Tamrakar D, Maharjan B, Dual R, Shrestha RK, Koju S, et al. Boost up quality assurance through regular evaluation of proficiency testing performance. Ann Clin Chem Lab Med. 2018; 3(1):3-7. [DOI] [Google Scholar]
6. Yerram S. External quality assurance scheme (EQAS): Criteria for evaluating performance of a laboratory. IOSR Journal of Biotechnology and Biochemistry (IOSR-JBB). 2018; 4.4: 16-20. [View at Publisher] [Google Scholar]
7. Westgard JO. Internal quality control: planning and implementation strategies. Ann. Clin. Biochem. 2003; 40 (Pt 6): 593-611. [View at Publisher] [DOI] [PMID] [Google Scholar]
8. World Health Organization. Laboratory quality management system : handbook, Version 1.1. (‎2011)‎. [View at Publisher]
9. Sciacovelli L, Secchiero S, Padoan A, Plebani M. External quality assessment programs in the context of ISO 15189 accreditation. Clin. Chem. Lab. Med. 2018; 56(10):1644-1654. [View at Publisher] [DOI] [PMID] [Google Scholar]
10. Miller WG, Jones GR, Horowitz GL, Weykamp C. Proficiency testing/external quality assessment: current challenges and future directions. Clin. Chem. 2011; 57(12) :1670-1680. [View at Publisher] [DOI] [PMID] [Google Scholar]
11. CLSI. Using proficiency testing and assessment to improve medical laboratory quality. 3rded. CLSI Guidelines QMS24. Wayne PA. Clinical And Laboratory Standards Institute; 2016. [View at Publisher]
12. Sciacovelli L, Secchiero S, Zardo L, Plebani M. The role of the External Quality Assessment. Biochemia Medica. 2010; 20(2): 160-164. [View at Publisher] [DOI] [Google Scholar]
13. Tiwari E, Mishra S, Singh S, Mishra M. External Quality Assessment Scheme in Biochemistry: Four Years Experience as a Participating Laboratory. Int. J Sci Stud. 2016; 4(4):106-110. [View at Publisher]
14. Badrick T, Gay S, McCaughey EJ, Georgiou A. External Quality Assessment beyond the analytical phase: an Australian perspective. Biochem. Med (Zagreb). 2017; 27(1): 73-80. [View at Publisher] [DOI] [PMID] [Google Scholar]
15. Dufraing K, Lierman, E, Vankeerberghen A, Franke S, Dequeker E. External quality assessment for molecular diagnostic laboratories in Belgium: Can we improve it? Accred. Qual. Assur. 2020; 25: 39-49. [View at Publisher] [DOI] [Google Scholar]
16. World Health Organization. Laboratory quality management system : handbook, Version 1.1. 2011. [View at Publisher]
17. World Health Organization‎. Laboratory quality management system : handbook, Version 1.1. 2011. [View at Publisher]
18. Karkalousos P, Evangelopoulos A. Quality control in clinical laboratories, applications and experiences of quality control. Prof. OgnyanIvanov(Ed.). 2011; ISBN:978-953-307-2364. [View at Publisher] [DOI] [Google Scholar]
19. Kristensen GB, Meijer P. Interpretation of EQA results and EQA-based trouble shooting. Biochem. Med (Zagreb). 2017; 27(1):49-62. [View at Publisher] [DOI] [PMID] [Google Scholar]
20. Hastings RJ, Howell RT. The importance and value of EQA for diagnostic genetic laboratories. J. Community Genet. 2010; 1(1):11-7. [DOI] [PMID] [Google Scholar]
21. Blasutig IM, Wheeler SE, Bais R, Dabla PK, Lin, J, Perret-Liaudet A, et al. External quality assessment practices in medical laboratories: an IFCC global survey of member societies. Clin. Chem. Lab. Med. 2023;61(8):1404-1410. [View at Publisher] [DOI] [PMID] [Google Scholar]
22. Medical laboratories - Requirements for quality and competence (ISO 15189:2012)BS EN ISO 15189:2012,BSI Standards Publication, IP:The University of Leeds, Version correct as of 11/04/2013 22:47, (c) The British Standards Institution 2013. [View at Publisher]
23. Medical laboratories - Requirements for quality and competence. INTERNATIONAL STANDARD ISO 15189 Fourth edition 2022-12. [View at Publisher]
24. Payne DA, Russomando G, Linder MW, Baluchova K, Ashavaid T, Steimer W, et al. IFCC Committee for Molecular Diagnostics (C-MD). External quality assessment (EQA) and alternative assessment procedures (AAPs) in molecular diagnostics: findings of an international survey. Clin. Chem. Lab. Med. 2020; 59(2):301-306. [View at Publisher] [DOI] [PMID] [Google Scholar]

Add your comments about this article : Your username or Email:
CAPTCHA

Send email to the article author


Rights and permissions
Creative Commons License This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.

© 2007 All Rights Reserved | Medical Laboratory Journal

Creative Commons License
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.