Application of failure mode and effect analysis in the detection of severe acute respiratory syndrome coronavirus 2 nucleic acid_West China Medical Journal

Authors：

HU Dong , CHEN Xi , XU Mingyong , ZENG Jiawei , LUO Jun ,  FENG Jiafu

Department of Clinical Laboratory, Mianyang Central Hospital, Mianyang, Sichuan 621000, P. R. China;

Corresponding author：

FENG Jiafu, Email: jiafufeng@aliyun.com

Keywords：

Failure mode and effect analysis; Severe acute respiratory syndrome coronavirus 2; Nucleic acid detection; Emergency

DOI：

10.7507/1002-0179.202008225

Video：

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Objective To use failure mode and effect analysis (FMEA) to check and improve the risk of severe acute respiratory syndrome coronavirus 2 nucleic acid detection, and explore the application effect of FMEA in the emergency inspection items.Methods FMEA was used to sort out the whole process of severe acute respiratory syndrome coronavirus 2 nucleic acid detection from January 30 to February 21, 2020. By establishing the theme, setting up a team, analyzing the failure mode and potential influencing factors. Then calculate the risk priority number (RPN), formulate preventive measures and implement continuous improvement according to the analysis results.Results A total of 2 138 cases were included. After improvement, the number of potential failure modes has been reduced by 2 (17 vs.19); the value of total RPN decreased (3 527.49 vs. 1 858.28). There was significant difference in average RPN before and after improvement [(185.66±74.34) vs. (97.80±37.97); t=6.128, P<0.001].Conclusions In the early stage of emergency inspection items, using FMEA can systematically check the risk factors in the process, develop improvement measures. It also can effectively reduce the risk of severe acute respiratory syndrome coronavirus 2 nucleic acid detection in hospital.

Citation： HU Dong, CHEN Xi, XU Mingyong, ZENG Jiawei, LUO Jun, FENG Jiafu. Application of failure mode and effect analysis in the detection of severe acute respiratory syndrome coronavirus 2 nucleic acid. West China Medical Journal, 2021, 36(8): 1011-1015. doi: 10.7507/1002-0179.202008225 Copy

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13.	Guiñón L, Soler A, Gisell Díaz M, et al. Analytical performance assessment and improvement by means of the failure mode and effect analysis (FMEA). Biochem Med (Zagreb), 2020, 30(2): 020703.
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15.	David RE, Dobreanu M. Pre-analytical components of risk in four branches of clinical laboratory in Romania--prospective study. Clin Lab, 2016, 62(6): 1033-1044.
16.	魏万宏, 郭敏, 宋晓启, 等. 基于共词聚类的 FMEA 在我国医院管理中研究热点分析. 中国医院管理, 2019, 39(3): 47-50, 59.
17.	盛哈蕾, 姜露, 陈锦, 等. FMEA 在科研实验室危险化学品管理中的应用. 中国卫生质量管理, 2019, 26(5): 12-15.
18.	王睿, 李延来, 朱江洪, 等. 考虑专家共识的改进 FMEA 风险评估方法. 浙江大学学报(工学版), 2018, 52(6): 1058-1067.

1. 中华人民共和国中央人民政府. 国家卫生健康委员会办公厅关于印发新型冠状病毒肺炎防控方案(第五版)的通知. (2020-02-21)[2020-08-20]. http://www.gov.cn/zhengce/zhengceku/2020-02/22/content_5482010.htm.
2. 邱峰, 王慧君, 张子康, 等. 新型冠状病毒 SARS-CoV-2 的实验室检测技术. 南方医科大学学报, 2020, 40(2): 164-167.
3. Karadağ C, Demirel NN. Continual improvement of the pre-analytical process in a public health laboratory with quality indicators-based risk management. Clin Chem Lab Med, 2019, 57(10): 1530-1538.
4. Mackay MA, Badrick TC. Steady state errors and risk of a QC strategy. Clin Biochem, 2019, 64: 37-43.
5. 陈建伟, 孙吉花, 支红敏, 等. 应用失效模式与效应分析防范手术中血源性职业暴露. 中国感染控制杂志, 2019, 18(8): 776-782.
6. AIAG VDA. 失效模式及影响分析 FEMA 手册. 5 版, 北京: 中国标准出版社, 2019.
7. 官龙建, 廖化敏. 失效模式与效应分析在低温等离子灭菌质量管理中的应用. 重庆医学, 2015, 44(25): 3594-3595, 3600.
8. 张琼, 张际. 失效模式与效应分析在我国医院质量管理中的应用. 重庆医学, 2014, 43(27): 3665-3666, 3671.
9. 陈淑贤, 俞洪水, 桑彤. 基于模糊 FMEA 分析方法的检验机构废弃物管理. 实验室研究与探索, 2019, 38(9): 298-302.
10. 匡慧慧, 于梅, 于帅, 等. 新型冠状病毒实验室核酸检测方法及实践. 中华医院感染学杂志, 2020, 30(6): 830-833.
11. 徐宝丽, 管甲亮, 术超, 等. 新型冠状病毒 COVID-19 相关研究进展. 中华医院感染学杂志, 2020, 30(6): 839-844.
12. Janssens PMW, van der Horst A. Improved prospective risk analysis for clinical laboratories compensated for the throughput in processes. Clin Chem Lab Med, 2018, 25, 56(11): 1878-1885.
13. Guiñón L, Soler A, Gisell Díaz M, et al. Analytical performance assessment and improvement by means of the failure mode and effect analysis (FMEA). Biochem Med (Zagreb), 2020, 30(2): 020703.
14. Kisling K, Johnson JL, Simonds H, et al. A risk assessment of automated treatment planning and recommendations for clinical deployment. Med Phys, 2019, 46(6): 2567-2574.
15. David RE, Dobreanu M. Pre-analytical components of risk in four branches of clinical laboratory in Romania--prospective study. Clin Lab, 2016, 62(6): 1033-1044.
16. 魏万宏, 郭敏, 宋晓启, 等. 基于共词聚类的 FMEA 在我国医院管理中研究热点分析. 中国医院管理, 2019, 39(3): 47-50, 59.
17. 盛哈蕾, 姜露, 陈锦, 等. FMEA 在科研实验室危险化学品管理中的应用. 中国卫生质量管理, 2019, 26(5): 12-15.
18. 王睿, 李延来, 朱江洪, 等. 考虑专家共识的改进 FMEA 风险评估方法. 浙江大学学报(工学版), 2018, 52(6): 1058-1067.

West China Medical Journal

Application of failure mode and effect analysis in the detection of severe acute respiratory syndrome coronavirus 2 nucleic acid

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