Indian Journal of Medical Biochemistry

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VOLUME 29 , ISSUE 1 ( January-April, 2025 ) > List of Articles

ORIGINAL RESEARCH ARTICLE

Auditing Internal Quality Control Practices in a Large Size Clinical Biochemistry Laboratory

Jayesh Warade

Keywords : Audit, Clinical biochemistry, Competency assessment, Immunoassay, Internal quality control, Risk, Therapeutic drug

Citation Information : Warade J. Auditing Internal Quality Control Practices in a Large Size Clinical Biochemistry Laboratory. Indian J Med Biochem 2025; 29 (1):13-18.

DOI: 10.5005/jp-journals-10054-0243

License: CC BY-NC 4.0

Published Online: 20-12-2024

Copyright Statement:  Copyright © 2025; The Author(s).


Abstract

Background: Auditing quality control practices is crucial for ensuring adherence to and compliance with the standard operating procedures of quality assurance. This study examines the internal quality control (IQC) practices in clinical biochemistry laboratories, focusing on their effectiveness in ensuring accurate and reliable test results. Materials and methods: A comprehensive audit was conducted every month, and records were reviewed periodically in a high-volume clinical biochemistry lab, assessing compliance with established IQC protocols and identifying areas for improvement. Chi-square test was used to assess any significant deviations in the practices from the established protocols. Results: Overall compliance with IQC practices was 98.8%. The compliance rates of 100% were observed for LJ Chart, Monthly CV%, measurement uncertainty, mean SD calculation, IQC lot verification, accuracy testing records, and kit verification records. Lower compliance rates were noted for patient moving average records at 95.8%. Out-of-control events occurred in 0.12% of the IQC tests. The overall average audit score for six months stands at 94.3%. Conclusion: The findings reveal very minimal variations in IQC implementation as compared to standard operating procedures and provide recommendations for enhancing quality control processes.


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  1. Sciacovelli L, Secchiero S, Zardo L, et al. The role of the internal quality control in the clinical laboratory. Clin Chem Lab Med 2004;42(7): 883–889. DOI: 10.1515/CCLM.2004.155.
  2. Lhajjam H, Azzouzi H, Sefiani N, et al. The importance of the internal quality controls in medical laboratories to ensure high quality results. J Bras Patol Med Lab 2023;59(2):07–17. DOI: 10.1900/JBPML.2023.59.02.002.
  3. Marques-Garcia F, Garcia-Codesal MF, Caro-Narros MR, et al. Importance of implementing an analytical quality control system in a core laboratory. Rev Calid Asist 2015;30(6):302–309. DOI: 10.1016/j.cali.2015.07.007.
  4. International Organization for Standardization (ISO). ISO 15189:2022 - Medical laboratories – Requirements for quality and competence. Geneva, Switzerland: ISO. 2022. Available from: https://www.iso.org/standard/76677.html.
  5. Yundt-Pacheco J, Nerenz RD, Olson JD. Using risk management to improve quality control practices in the clinical laboratory. Clin Lab Med 2013;33(1):21–36. DOI: 10.1016/j.cll.2012.11.007.
  6. Westgard JO, Barry PL, Hunt MR, et al. A multi-rule Shewhart chart for quality control in clinical chemistry. Clin Chem 1981;27(3):493–501. PMID: 7471403.
  7. Chi Square Test (2024) iCalcu.com. Accessed on 7th June 2024. Available from: https://www.icalcu.com/stat/chisqtest.html.
  8. Housley D, Kearney E, English E, et al. Audit of internal quality control practice and processes in the south-east of England and suggested regional standards. Annals of Clinical Biochemistry 2008;45(2): 135–139. DOI: 10.1258/acb.2007.007028.
  9. NABL 112 document. Specific Criteria for Accreditation of Medical Laboratories (2019) Issue 04; amendment 01: 29. Available from: https://nabl-india.org/nabl/file_download1.php?filename=201905031045-NABL-112-effective-from-01.06.2019-doc.pdf.
  10. Lukić V, Ignjatović S. Moving average procedures as an additional tool for real-time analytical quality control: Challenges and opportunities of implementation in small-volume medical laboratories. Biochem Med (Zagreb) 2022;32(1):010705. DOI: 10.11613/BM.2022. 010705.
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