Quality Control Errors in Clinical Laboratories: Sources, Impact, and Preventive Strategies

  • Unique Paper ID: 189652
  • Volume: 12
  • Issue: 7
  • PageNo: 7732-7737
  • Abstract:
  • Quality control (QC) is a cornerstone of reliable laboratory diagnostics, directly influencing patient care, clinical decision-making, and healthcare outcomes. Despite advances in automation and standardization, clinical laboratories continue to face quality control errors that compromise test accuracy and reliability. These errors may arise during pre-analytical, analytical, or post-analytical phases and can result from human factors, instrument malfunction, reagent variability, environmental conditions, or inadequate quality management systems. This review provides a comprehensive analysis of quality control errors in clinical laboratories, including their classification, root causes, and clinical impact. Current quality control practices, statistical tools, and regulatory guidelines are discussed, along with emerging approaches such as risk-based QC, sigma metrics, automation, and digital quality management systems. Strategies for error prevention and continuous quality improvement are highlighted to enhance laboratory performance and patient safety.

Copyright & License

Copyright © 2026 Authors retain the copyright of this article. This article is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

BibTeX

@article{189652,
        author = {Aditi Sharma and Anshika Dhiman and Prachi Rana and Tarushi Sharma and Rabi Raj Bhatt},
        title = {Quality Control Errors in Clinical Laboratories: Sources, Impact, and Preventive Strategies},
        journal = {International Journal of Innovative Research in Technology},
        year = {2025},
        volume = {12},
        number = {7},
        pages = {7732-7737},
        issn = {2349-6002},
        url = {https://ijirt.org/article?manuscript=189652},
        abstract = {Quality control (QC) is a cornerstone of reliable laboratory diagnostics, directly influencing patient care, clinical decision-making, and healthcare outcomes. Despite advances in automation and standardization, clinical laboratories continue to face quality control errors that compromise test accuracy and reliability. These errors may arise during pre-analytical, analytical, or post-analytical phases and can result from human factors, instrument malfunction, reagent variability, environmental conditions, or inadequate quality management systems. This review provides a comprehensive analysis of quality control errors in clinical laboratories, including their classification, root causes, and clinical impact. Current quality control practices, statistical tools, and regulatory guidelines are discussed, along with emerging approaches such as risk-based QC, sigma metrics, automation, and digital quality management systems. Strategies for error prevention and continuous quality improvement are highlighted to enhance laboratory performance and patient safety.},
        keywords = {Quality control, laboratory errors, analytical errors, sigma metrics, internal quality control, patient safety},
        month = {December},
        }

Cite This Article

Sharma, A., & Dhiman, A., & Rana, P., & Sharma, T., & Bhatt, R. R. (2025). Quality Control Errors in Clinical Laboratories: Sources, Impact, and Preventive Strategies. International Journal of Innovative Research in Technology (IJIRT), 12(7), 7732–7737.

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