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From assessment to action: experience from a quality improvement initiative integrating indicator evaluation and adverse event analysis in a clinical laboratory

质量管理 不利影响 质量(理念) 绩效指标 六西格玛 事件(粒子物理) 根本原因分析 运营管理 医学 工程类 可靠性工程 业务 管理制度 内科学 认识论 物理 精益制造 哲学 营销 量子力学
作者
Peirong Chen,Xing Chen,Yuanzhi Xia,Xiaoliang Liang,Qiuyi Hong
出处
期刊:Clinical Chemistry and Laboratory Medicine [De Gruyter]
卷期号:63 (12): 2415-2424
标识
DOI:10.1515/cclm-2025-0656
摘要

OBJECTIVES: ISO 15189:2022 recommends the use of quality indicators (QIs) to monitor laboratory performance and focuses on risk management and continual improvement. This study aims to compare hospital laboratory data with national and international quality specifications and to share experiences in quality improvement and adverse event management. METHODS: We evaluated 15 QIs from 2023 by comparing their percentages and sigma levels with those of national benchmarks to identify performance gaps. On the basis of this analysis, a series of data-driven continuous improvement projects were implemented in 2024. Adverse events were closely monitored and corrective actions were taken accordingly. Data from 2023 to 2024 were compared with national and international specifications, and statistical analysis was conducted using R Studio. RESULTS: Excluding internal quality control and interlaboratory comparison indicators, the remaining 13 QIs generally exhibited acceptable performance (σ>3.5). Statistically significant improvements (p<0.05) were observed in seven indicators. Overall, laboratory performance was ranked relatively low at the national level but favourably at the international level. The analysis of 15 adverse events revealed that errors occurred across all testing phases and involved multiple departments. CONCLUSIONS: The quality improvement initiatives implemented in 2024 yielded measurable improvements. Effective communication and interdisciplinary collaboration are essential for reducing errors and enhancing laboratory performance.
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