[1]郭华a,孙晶晶b,王晋平c.现场技术审核对PCR 实验室质量管理的影响分析[J].现代检验医学杂志,2020,35(05):164-167.[doi:10.3969/j.issn.1671-7414.2020.05.042]
　GUO Huaa,SUN Jing-jingb,WANG Jin-pingc.Analysis of the Influence of Field Technical Audit on PCR Laboratory Quality Management[J].Journal of Modern Laboratory Medicine,2020,35(05):164-167.[doi:10.3969/j.issn.1671-7414.2020.05.042]
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现场技术审核对PCR 实验室质量管理的影响分析()
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《现代检验医学杂志》[ISSN:/CN:]

卷:
第35卷
期数:
2020年05期
页码:
164-167
栏目:
质量控制·实验室管理
出版日期:
2020-11-01

文章信息/Info

Title:
Analysis of the Influence of Field Technical Audit on PCR Laboratory Quality Management
文章编号:
1671-7414（2020）05-164-04
作者:
郭华a; 孙晶晶b; 王晋平c
陕西省人民医院a. 检验科；b. 临床检验中心；c. 耳鼻喉科，西安 710068
Author(s):
GUO Huaa;  SUN Jing-jingb; WANG Jin-pingc
a.Department of Clinical Laboratory; b.Clinical Laboratory Centers；c.Department of Otolaryngology, Shaanxi Provincial People’s Hospital, Xi’an 710068，China
关键词:
聚合酶链式反应; 质量管理; 室间质评
分类号:
R446
DOI:
10.3969/j.issn.1671-7414.2020.05.042
文献标志码:
A
摘要:
目的　总结临床PCR 实验室参加室间质量评价活动的PT 结果，探讨现场审核与否对室间质评结果的影响， 进而分析实验室现场审核对其质量管理的影响。方法　统计分析2008~2019 年陕西省临床检验中心PCR(HBV-DNA， HCV-RNA) 参评实验室室间质评活动结果。结果　① 2008~2019 年累计参评HBV-DNA 的实验室次数为617 次，其中 通过现场审核的实验室累计数450 次，合格单位累计数437 次，平均能力比对96.4%，合格率97.1%；未通过现场审 核的实验室累计数167 次，合格单位累计数149 次，平均能力比对88.3%，合格率89.2%；② 2008~2019 年累计参评 HCV-RNA 的实验室数为526 次，其中通过现场审核的实验室累计数425 次，合格单位累计数414 次，平均能力比对 96.6%，合格率97.4%；未通过现场审核的实验室累计数101 次，合格单位累计数96 次，平均能力比对 92.9%，合格率 95.0%；③ HBV-DNA 2008~2019 年累计合格率经 χ2 检验，二者比较差异有统计学意义（χ2=15.888，P ＜ 0.001）。结论　 通过现场审核的PCR 实验室能严格进行规范操作，有助于做好室间质评工作，有效提高临床检测的水平和质量。
Abstract:
Objective　To analyze the PT results of clinical PCR laboratory participating in the inter room quality evaluation activities,explore the influence of the on-site audit of PCR laboratory on the results of the inter room quality evaluation, and then to analyze the influence of the on-site audit of the laboratory on its quality management. Methods　Statistical analysis of the results of EIA activities in the evaluation laboratories of HBV-DNA and HCV-RNA in Shaanxi Clinical Laboratory Center from 2008 to 2019 were carried out. Results　① In 2008~2019, the total number of laboratories participating in the evaluation of HBV-DNA was 617, including 450 laboratories passing the on-site audit, 437 qualified units, with an average of PT 96.4%, and a qualified rate of 97.1%. 167 laboratories failing to pass the on-site audit, 149 qualified units, with an average of PT 88.3%, and a qualified rate of 89.2%. ② In 2008~2019, there were 526 laboratories participating in the evaluation of HCV-RNA, including 425 laboratories passing the on-site audit, 414 qualified laboratories, with an average of PT 96.6% and a qualified rate of 97.4%.101 laboratories failing to pass the on-site audit, with an average of PT 92.9% and a qualified rate of 95.0%. ③ The cumulative eligibility rate of HBV-DNA in 2008~2019 was 15.888 and P<0.001 by χ2 test. There was statistical significance between them. Conclusion　The PCR laboratory that has passed the on-site audit can strictly carry out the standardized operation, which is helpful to do a good job in the work of inter laboratory quality assessment and effectively improve the level and quality of clinical testing.

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备注/Memo

备注/Memo:
基金项目：陕西省自然科学基础研究计划项目（2018JM7145）。
作者简介：郭华（1977- ），女，主管技师，主要从事临床检验工作，E-mail：guohua1123@163.com。
通讯作者：孙晶晶（1984- ），女，主管技师，主要从事临床检验室间质评工作，E-mail：dnafail@163.com。
更新日期/Last Update: 2020-10-30