整合质量指标对人乳头瘤病毒基因分型检测全过程进行风险评估的失效模式与效应分析(FMEA):一种分子诊断的前瞻性风险分析模型。

IF 3.7 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY
Tingting Li, Yuting He, Yuanhao Chen, Shunwang Cao, Yi Wang, Chunmin Kang, Hongmei Wang, Cheng Zhang, Chang Wen, Peifeng Ke
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引用次数: 0

摘要

目的:通过将失效模式和影响分析(FMEA)与质量指标(QIs)相结合,建立人乳头瘤病毒(HPV)基因分型检测的前瞻性风险评估模型,确保符合ISO 15189:2022标准,提高诊断准确性。方法:一个多学科团队设计并执行了HPV基因分型检测的分析前、分析和分析后阶段的详细FMEA。为了提高客观性,我们通过QIs的分子诊断特异性模型(MQI)将Sigma指标整合到FMEA框架中。FMEA模型系统地识别了测试阶段、潜在失效模式、它们的影响、根本原因和现有控制。使用严重性、发生率(来自1年QI数据)和检测评分(1-5量表)对风险进行量化。计算风险优先级数(RPN)(严重性×发生×检测)来确定故障模式的优先级,并对高风险项目(RPN≥40)实施强制性干预。结果:五种高风险失效模式(例如,样本错误识别,数据分析错误)被确定并成功减轻到可接受的水平(rpn结论:本研究开发了用于HPV基因分型检测的集成FMEA- qi模型,建立了传统的FMEA框架和分子诊断特异性MQI。与传统方法相比,该方法提高了风险评估的客观性,实现了多维度分析。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Failure Mode and Effects Analysis (FMEA) integrating quality indicators for risk assessment of the total testing process in human papillomavirus genotyping testing: a proactive risk analysis model for molecular diagnostics.

Objectives: To develop a proactive risk assessment model for human papillomavirus (HPV) genotyping testing by integrating Failure Mode and Effects Analysis (FMEA) with quality indicators (QIs), ensuring compliance with ISO 15189:2022 and improving diagnostic accuracy.

Methods: A multidisciplinary team designed and performed detailed FMEA across pre-analytical, analytical, and post-analytical phases of HPV genotyping testing. To improve objectivity, we integrated Sigma metrics into the FMEA framework through a molecular diagnostics-specific model of QIs (MQI). The FMEA model systematically identified testing phases, potential failure modes, their effects, root causes, and existing controls. Risk was quantified using Severity, Occurrence (from 1-year QI data), and Detection scores (1-5 scale). Risk Priority Numbers (RPNs) were calculated (Severity × Occurrence × Detection) to prioritize failure modes, with mandatory interventions implemented for high-risk items (RPN≥40).

Results: Five high-risk failure modes (e.g., sample misidentification, data analysis errors) were identified and successfully mitigated to acceptable levels (RPN<40) through process optimization and standardization, achieving RPN reductions of 20-80 %. We established a molecular diagnostics-specific MQI, comprising 14 pre-analytical, 25 analytical, and three post-analytical phase QIs. QI-based risk assessment of 35 evaluable QIs for HPV genotyping testing revealed one high-risk QI ("Incorrect results due to information system failures") and three medium-risk QIs, all of which were addressed through corrective actions.

Conclusions: This study developed an integrated FMEA-QI model for HPV genotyping testing, establishing both a traditional FMEA framework and a molecular diagnostics-specific MQI. The combined approach improves risk assessment objectivity and enables multidimensional analysis compared to conventional methods.

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来源期刊
Clinical chemistry and laboratory medicine
Clinical chemistry and laboratory medicine 医学-医学实验技术
CiteScore
11.30
自引率
16.20%
发文量
306
审稿时长
3 months
期刊介绍: Clinical Chemistry and Laboratory Medicine (CCLM) publishes articles on novel teaching and training methods applicable to laboratory medicine. CCLM welcomes contributions on the progress in fundamental and applied research and cutting-edge clinical laboratory medicine. It is one of the leading journals in the field, with an impact factor over 3. CCLM is issued monthly, and it is published in print and electronically. CCLM is the official journal of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) and publishes regularly EFLM recommendations and news. CCLM is the official journal of the National Societies from Austria (ÖGLMKC); Belgium (RBSLM); Germany (DGKL); Hungary (MLDT); Ireland (ACBI); Italy (SIBioC); Portugal (SPML); and Slovenia (SZKK); and it is affiliated to AACB (Australia) and SFBC (France). Topics: - clinical biochemistry - clinical genomics and molecular biology - clinical haematology and coagulation - clinical immunology and autoimmunity - clinical microbiology - drug monitoring and analysis - evaluation of diagnostic biomarkers - disease-oriented topics (cardiovascular disease, cancer diagnostics, diabetes) - new reagents, instrumentation and technologies - new methodologies - reference materials and methods - reference values and decision limits - quality and safety in laboratory medicine - translational laboratory medicine - clinical metrology Follow @cclm_degruyter on Twitter!
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