紧急转制的新型冠状病毒感染患者定点收治医院检验科的应急转型经验

doi:10.16150/j.1671-2870.2022.02.016

摘要/Abstract

摘要：

2021年2月下旬,上海出现了一轮本土新型冠状病毒（简称新冠病毒）感染疫情,使得新冠疫情由常态化防控转为疫情防控攻坚战。根据国家卫生健康委印发《区域新型冠状病毒核酸检测组织实施指南（第三版）》要求,具备核酸检测能力的各级医疗机构迅速开展新型冠状病毒核酸检测,这给非定点收治新冠患者医院紧急转制为定点医院提出了更高的检测防控要求。检验科作为与新冠病毒检测标本近距离接触的临床科室,存在实验室工作时间长、工作强度大,面临临床常规标本和核酸标本气溶胶和接触传播的潜在风险,更需科室组织管理、人力资源规划、实验室核酸检测、实验室感染防控、医疗物资保障、工作人员心理疏导等多方面完善。本文结合上海交通大学医学院附属瑞金医院北部院区检验科应急转型工作实践,包括人员配置、临床样本的检测项目规划、核酸应急检测建立,科学、规范、有序开展相关工作,为兄弟单位提供检验科在应对新冠肺炎疫情紧急检测统筹管理方面的经验。

关键词: 新型冠状病毒, 核酸标本, 检验科, 应急检测

Abstract:

In late February 2021, a round of indigenous novel coronavirus (referred to as COVID-19) infection emerged in Shanghai, making the COVID-19 outbreak shift from regular prevention and control to drastic pandemic prevention and control measures. According to the requirements of the Guidelines for the Organization and Implementation of Regional Novel Coronavirus Nucleic Acid Testing (Third Edition) issued by the National Health and Wellness Commission, medical institutions at all levels with nucleic acid testing capabilities rapidly carried out novel coronavirus nucleic acid testing, which put forward higher requirements for testing and prevention and control for the emergency conversion of non-designated admission hospitals to designated hospitals. As a clinical department with close contact with novel coronavirus testing specimens, the department of clinical laboratory has long working hours and high work intensity, as well as the potential risk of aerosol and contact transmission of clinical routine specimens and nucleic acid specimens, which requires more improvement from human resource planning, laboratory nucleic acid testing, laboratory infection prevention and control, medical material security, and staff psychological guidance. In this paper, we hope to combine the practice of emergency transformation work of the laboratory department in the northern hospital area of Ruijin Hospital, including personnel allocation, planning of testing items for clinical samples, and establishment of emergency nucleic acid testing, to carry out relevant work in a scientific, standardized and orderly manner, and provide our associate organizations with valuable experience in the coordination and management of emergency testing in the laboratory department in response to the novel coronavirus outbreak.

Key words: Novel coronavirus, nucleic acid specimen, department of clinical laboratory, emergency detection

中图分类号:

R715.2

孟俊, 金佩佩, 陈长强, 陈韭铭, 范臻佳, 陈诗恺, 戴菁. 紧急转制的新型冠状病毒感染患者定点收治医院检验科的应急转型经验[J]. 诊断学理论与实践, 2022, 21(02): 184-188.

MENG Jun, JIN Peipei, CHEN Changqiang, CHEN Jiuming, FAN Zhenjia, CHEN Shikai, DAI Jing, et al . Emergency transformation experience of the laboratory department of a hospital designated for admission of patients with novel coronavirus infection in emergency conversion[J]. Journal of Diagnostics Concepts & Practice, 2022, 21(02): 184-188.

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参考文献 16

[1]	梁万年, 姚建红, 吴敬, 等. 我国新型冠状病毒肺炎疫情防控常态化阶段的经验与思考[J]. 中华医学杂志, 2021, 101(10):695-699.
	Liang WN, Yao JH, Wu J, et al. Experience and Thinking on the normalization stage of prevention and control of novel coronavirus pneumonia in China[J]. Natl Med J Chin, 2021, 101(10):695-699.
[2]	Zhang X, Zhang W, Chen S. Shanghai's life-saving efforts against the current omicron wave of the COVID-19 pandemic[J]. Lancet, 2022: S0140-6736(22)00838-8.
[3]	Rahbari R, Moradi N, Abdi M. rRT-PCR for SARS-CoV-2: Analytical considerations[J]. Clin Chim Acta, 2021, 516:1-7. doi: 10.1016/j.cca.2021.01.011 pmid: 33485902
[4]	国务院应对新型冠状病毒肺炎疫情联防联控机制综合组. 区域新型冠状病毒核酸检测组织实施指南(第三版)[EB/OL]. http://www.nhc.gov.cn/yzygj/s7659/202203/b5aaa96dfe1b4f14b19bf2f888a10673.shtml.
	Comprehensive group of the State Council on joint prevention and control mechanism for novel coronavirus pneumonia. Regional guidelines for the organization and implementation of nucleic acid detection of novel coronavirus (Third Edition)[EB/OL]. http://www.nhc.gov.cn/yzygj/s7659/202203/b5aaa96dfe1b4f14b19bf2f888a10673.shtml.
[5]	广州实验室新型冠状病毒核酸应急检测专家组. 大规模多场景移动实验室新型冠状病毒核酸应急检测专家共识[J]. 中华医学杂志, 2021, 101(40):3271-3277.
	Emergency detection expert group of novel coronavirus nucleic acid in Guangzhou Laboratory. Expert consensus on emergency detection of novel coronavirus nucleic acid in large-scale multi scene mobile laboratory[J]. Natl Med J Chin, 2021, 101(40):3271-3277.
[6]	林南清, 宋国伟. 检验人员的职业暴露及生物安全防护[J]. 检验医学与临床, 2011, 8(6):767-767.
	Lin NQ, Song GW. Occupational exposure and biosafety protection of inspectors[J]. Lab Med Clin, 2011, 8(6):767-767.
[7]	周帅锋, 李世康, 陈雨, 等. 微滴式数字PCR和实时荧光定量PCR对新型冠状病毒肺炎患者不同时间血便尿中核酸检测结果初步探讨[J]. 实用预防医学, 2020, 27(11):1316-1320.
	Zhou SF, Li SK, Chen Y, et al. Detection of nucleic acid in blood, stool and urine of patients with novel coronavirus pneumonia at different times by micro drop digital PCR and real-time fluorescent quantitative PCR[J]. Pract Prev Med, 2020, 27(11):1316-1320.
[8]	中华人民共和国国务院. 病原微生物实验室生物安全管理条例[EB/OL]. 2010-12-31[2020-02-24]. .
	State Council of the PRC. Regulations on biosafety management of pathogenic microorganism laboratory[EB/OL]. 2010-12-31[2020-02-24]. .
[9]	中华人民共和国国务院. 医疗废物管理条例[EB/OL]. 2003-06-04[2020-02-24]. .
	State Council of the PRC. Regulations on the administration of medical waste[EB/OL]. 2003-06-04[2020-02-24]. .
[10]	中华人民共和国国家质量监督检验检疫总局, 中国国家标准化管理委员会. GB 19489-2008 实验室生物安全通用要求[S]. 北京: 中国标准出版社, 2008.
	General Administration of quality supervision, inspection and Quarantine of the people's Republic of China, China National Standardization Administration Committee. GB 1948-2008 General requirements for laboratory biosafety[S]. Beijing: China Standards Press, 2008.
[11]	国务院应对新型冠状病毒肺炎疫情联防联控机制医疗救治组. 医疗机构新型冠状病毒核酸检测工作手册(试行第二版)[EB/OL]. http://www.nhc.gov.cn/yzygj/s7659/202012/b89bcd0813da41788688eb14787b3c72.shtml.
	Medical treatment team of the State Council for joint prevention and control of novel coronavirus pneumonia.. Working manual for nucleic acid detection of novel coronavirus in medical institutions (trial version 2)[EB/OL]. http://www.nhc.gov.cn/yzygj/s7659/202012/b89bcd0813da41788688eb14787b3c72.shtml.
[12]	国家卫生健康委办公厅. 新型冠状病毒实验室生物安全指南(第二版)[EB/OL]. http://www.nhc.gov.cn/xcs/zhengcwj/202001/0909555408d842a58828611dde2e6a26.shtml.
	General Office of National Health Commission. Laboratory biosafety guidelines for novel coronavirus (Second Edition)[EB/OL]. http://www.nhc.gov.cn/xcs/zhengcwj/202001/0909555408d842a58828611dde2e6a26.shtml.
[13]	程丽, 郑丽平, 晏苏玉, 等. 新型冠状病毒肺炎患者焦虑现状及影响因素分析[J]. 浙江医学, 2020, 42(4):315-317.
	Chen L, Zhen LP, Yan SY, et al. Analysis of anxiety status and influencing factors in patients with novel coronavirus pneumonia[J]. Zhejiang Med J, 2020, 42(4):315-317.
[14]	马翠, 严兴科. 新型冠状病毒肺炎疫情的心理应激反应和防控策略研究进展[J]. 吉林大学学报(医学版), 2020, 46(3):649-654.
	Ma C, Yan XK. Research Progress on psychological stress response and prevention and control strategy of novel coronavirus pneumonia[J]. J Jilin Univ (Med Ed), 2020, 46(3):649-654.
[15]	龚娅, 刘志强, 段德令, 等. 新型冠状病毒肺炎疫情非定点医院检验科整体防护策略[J]. 国际检验医学杂志, 2020, 41(19):2429-2432.
	Gong Y, Liu ZQ, Duan DL, et al. Overall protection strategy of laboratory departments in non designated hospitals in the epidemic situation of novel coronavirus pneumonia[J]. Int J Lab Med, 2020, 41(19):2429-2432.
[16]	中华人民共和国中央人民政府. 突发公共卫生事件应急条例[EB/OL]. [2021-03-12].
	The Central People's Government of the People's Republic of China. Regulations on emergency response to public health emergencies[EB/OL]. [2021-03-12].

工作岗位	具体分工	资质要求
总指挥	对总体任务负责：负责任务的规划部署、统筹协调内外部资源;有相对应的人事任免及物资购买审批权限;负责对任务总体进度进行管控	医疗副院长、医务处长
实验室检测团队负责人	对常规核酸检测任务总负责：承接上级下达任务;负责统筹实验室日常各项工作（核酸排班、绩效考评、人员培训）	检验科行政副主任以上级别
检测技术人员	日常核酸检测试剂配置、标本抽提及质量控制、核酸标本的结果上报;实验室生物安全管理及日常废弃物清理消杀	医学检验专业背景并取得检验技术资格;持有PCR检测上岗证或新型冠状病毒核酸检测培训合格证（临检中心颁发）
其他相关人员	配合实验室正常运行的相关工作:如水电、信息维护、环境管理;实验室试剂、耗材、设备等相关物资的申购领取;实验室人员日常生活及宣传报道	护理部、后勤资产管理处、总务处、计算机信息中心、宣传处等保障部门行政副主任以上级别

组别	人员	电脑及仪器配置
标本接受处理组	2	2台电脑
试剂配置组（试剂配置区）
PCR室检测组	1
方舱检测组	1
核酸加样组（标本制备区）
PCR室检测组	6	核酸抽提仪（96孔）6台
方舱检测组	3	核酸抽提仪（96孔）3台
报告发送组（基因扩增区）	2	荧光PCR扩增仪（96孔） 22台
总计	15

组别	上下班时间	工作时长
标本接受处理组	9 am~17 pm	8 h
试剂配置组（试剂配置区）	9 am~17 pm	8 h
核酸加样组（标本制备区）
PCR室检测组	10 am~18 pm	8 h
方舱检测组	10 am~18 pm	8 h
报告发送组（基因扩增区）	12 pm~22 pm	10 h

扩增结果	报告模式
ORF1ab基因,N基因Ct值均大于40或Ct阴性	阴性
ORF1ab基因,N基因Ct值中一个在35~40之间,另一个大于40或者Ct阴性时	阳性（并要求临床重新送样）
ORF1ab基因,N基因Ct值均小于35	阳性
ORF1ab基因,N基因Ct值均在35~40之间	阴性（向临床提供Ct值）