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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10.	匡慧慧, 于梅, 于帥, 等. 新型冠狀病毒實驗室核酸檢測方法及實踐. 中華醫院感染學雜志, 2020, 30(6): 830-833.
11.	徐寶麗, 管甲亮, 術超, 等. 新型冠狀病毒 COVID-19 相關研究進展. 中華醫院感染學雜志, 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.	Gui?ón 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.	魏萬宏, 郭敏, 宋曉啟, 等. 基于共詞聚類的 FMEA 在我國醫院管理中研究熱點分析. 中國醫院管理, 2019, 39(3): 47-50, 59.
17.	盛哈蕾, 姜露, 陳錦, 等. FMEA 在科研實驗室危險化學品管理中的應用. 中國衛生質量管理, 2019, 26(5): 12-15.
18.	王睿, 李延來, 朱江洪, 等. 考慮專家共識的改進 FMEA 風險評估方法. 浙江大學學報(工學版), 2018, 52(6): 1058-1067.

1. 中華人民共和國中央人民政府. 國家衛生健康委員會辦公廳關于印發新型冠狀病毒肺炎防控方案(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, 張子康, 等. 新型冠狀病毒 SARS-CoV-2 的實驗室檢測技術. 南方醫科大學學報, 2020, 40(2): 164-167.
3. Karada? 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. 陳建偉, 孫吉花, 支紅敏, 等. 應用失效模式與效應分析防范手術中血源性職業暴露. 中國感染控制雜志, 2019, 18(8): 776-782.
6. AIAG VDA. 失效模式及影響分析 FEMA 手冊. 5 版, 北京: 中國標準出版社, 2019.
7. 官龍建, 廖化敏. 失效模式與效應分析在低溫等離子滅菌質量管理中的應用. 重慶醫學, 2015, 44(25): 3594-3595, 3600.
8. 張瓊, 張際. 失效模式與效應分析在我國醫院質量管理中的應用. 重慶醫學, 2014, 43(27): 3665-3666, 3671.
9. 陳淑賢, 俞洪水, 桑彤. 基于模糊 FMEA 分析方法的檢驗機構廢棄物管理. 實驗室研究與探索, 2019, 38(9): 298-302.
10. 匡慧慧, 于梅, 于帥, 等. 新型冠狀病毒實驗室核酸檢測方法及實踐. 中華醫院感染學雜志, 2020, 30(6): 830-833.
11. 徐寶麗, 管甲亮, 術超, 等. 新型冠狀病毒 COVID-19 相關研究進展. 中華醫院感染學雜志, 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. Gui?ón 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. 魏萬宏, 郭敏, 宋曉啟, 等. 基于共詞聚類的 FMEA 在我國醫院管理中研究熱點分析. 中國醫院管理, 2019, 39(3): 47-50, 59.
17. 盛哈蕾, 姜露, 陳錦, 等. FMEA 在科研實驗室危險化學品管理中的應用. 中國衛生質量管理, 2019, 26(5): 12-15.
18. 王睿, 李延來, 朱江洪, 等. 考慮專家共識的改進 FMEA 風險評估方法. 浙江大學學報(工學版), 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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