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Quality Management in Molecular Diagnostic Practices

Book Title: Molecular Diagnostics and Genomic Medicine: Transforming Healthcare with AI

Editors: Dr. Alok Kumar Srivastav, Dr. Priyanka Das, Dr. Babasaheb Ghodke, and Dr. Nikita Pathak

Chapter: 9

DOI: https://doi.org/10.59646/978-81-69297-97-4_9

Authors: Nikita Pathak, Alok Kumar Srivastav, Priyanka Das, Babasaheb Ghodke

Abstract

Quality assurance and quality control in molecular diagnostics are essential for ensuring accuracy, reliability, and clinical validity of test results across all stages of laboratory workflows. The chapter highlights the integration of QA (proactive, system-based processes) and QC (reactive performance monitoring) within a comprehensive quality management system covering pre-analytical, analytical, and post-analytical phases. Regulatory frameworks such as CLIA, CAP, and ISO 15189 are discussed as critical standards for laboratory accreditation, compliance, and global harmonization. The importance of rigorous validation and verification processes is emphasized to establish analytical and clinical performance of molecular tests. Internal and external quality control measures, including proficiency testing, ensure consistent performance and inter-laboratory comparability. Additionally, robust documentation practices, standard operating procedures, and error management strategies such as root cause analysis and corrective actions support continuous quality improvement. Collectively, these systems enhance patient safety, diagnostic accuracy, and overall laboratory excellence.

Keywords: Quality assurance, Quality control, Molecular diagnostics, Validation, Proficiency testing, Laboratory standards.

References

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