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Advancing patient safety through laboratory quality indicators in clinical pathology
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DOI：10.1080/10408363.2026.2678823.png)
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Abstract
En 中文
Quality indicators (QIs) are widely used in clinical laboratories to support quality management, patient safety, and regulatory compliance. Although regulatory and accreditation frameworks emphasize the use of QIs across the total testing process, published literature has often focused on analytical performance or discipline-specific approaches. Less attention has been given to how QIs are selected, interpreted, and sustained across the full range of clinical pathology subspecialties in routine practice. This critical review examines the role of quality indicators within clinical pathology laboratories, with emphasis on their selection, implementation, interpretation, and integration into quality management systems. Regulatory and accreditation expectations from CLIA, CAP, ISO 15189, and the Joint Commission are used as contextual anchors. We describe a decision-oriented lifecycle for quality indicators that emphasizes risk-based prioritization, feasibility, actionability, and governance integration. Practical examples of quality indicators spanning the pre-analytical, analytical, and post-analytical phases are presented across multiple subspecialties. Approaches to quality indicator data analysis are discussed, with particular focus on longitudinal, within-laboratory monitoring as a practical strategy for identifying meaningful trends and guiding improvement in diverse practice settings. Quality indicators are most effective when used as adaptive management tools rather than static compliance measures. Their value depends on thoughtful selection aligned with patient risk and laboratory scope, consistent interpretation within local context, and sustained linkage to corrective and preventive action. By adopting a discipline-aware, practice-focused approach, clinical pathology laboratories can use quality indicators to support continuous improvement, enhance patient safety, and meet regulatory and accreditation expectations across evolving healthcare environments.
Keywords:
Quality indicators
performance indicators
clinical pathology
quality management
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