收稿日历:2020-05-25 跳蛋 露出
*基金形势:天津市慢性疾病防治科技紧要专项(16ZXMJSY00020)“新式取代吡咯类巯基荧光探针的脑梗死筛查和会诊的临床前继续”
①天津医科大学第二病院临床推行机构 天津 300211
②天津市环湖病院临床推行机构 天津 300350
③天津市海河病院老师科 天津 300350
作家简介:李晓华,女,(1982- ),硕士,支配药师,从事临床推行质地继续责任。
[著述编号] 1672-8270(2021)01-0122-04 [中图分类号] R197.39 [文献标记码] A
Research on quality assurance measures of IVD reagents in clinical trials/LI Xiao-hua, LI Li-feng, FENG
Zong-bin, et al//China Medical Equipment,2021,18(1):122-125.
[Abstract]
Objective:
T
o analyze the quality problems of in vitro diagnostic (IVD) reagents in clinical trials, and study
and formulate the measures of enhancing quality assurance of these reagents.
Methods:
Summarized and classified the
quality problems which were found in self-inspection of the clinical trial projects of IVD reagents of hospital, and used
the Pareto chart to count as statistics method, classify and analyze, and confirmed the main types of existing problems in
clinical trials, and used the fishbone diagram for root cause analysis. And then, formulated quality improvement measures
from trial design, trial implementation, data summary and reporting.
Results:
In the selected 4,235 samples of clinical
trials of IVD reagents who undertaken in hospital from 2013 to 2019, a total of 119 quality problems were found and were
summarized to 10 problem types, and the main factors of these problems were 6items included trial records, trial reagents,
program implementation, application materials, ethical review and documents, and original records. And the secondary
factor was 1 item test samples, and the general factors included research staff, inform consent and statistical analysis. The
fishbone diagram was applied to analyze the reasons that affect the quality of the trials跳蛋 露出, and then 17 quality improvement
measures were formulated for the 3 main procedures of clinical trials.
Conclusion:
The application of Pareto chart and
fishbone diagram analysis can sort out common quality problems and reasons of IVD reagents of clinical trials, and
formulate quality assurance measures for them, and ensure the quality of IVD reagents of clinical trials from the source.
[Key words]
In vitro diagnostic (IVD) reagent; Clinical trial; Quality control; Root cause analysis
[First-author’s address]
Department of Clinical T
rials, The Second Hospital of Tianjin Medical University, Tianjin
300211, China.
[概要]
指标:
分析体外会诊试剂临床推行中的质地问题,继续制定其质地保证晋升门径。
格局:
汇总病院体外会诊试剂
临床推行形势自查发现的质地问题并进行分类,愚弄帕累托图对其进行统计、分类和分析,笃定临床推行中存在问题的主
要类型,应用鱼骨图进行根因分析,从推行瞎想、推行实施和数据追思与论述法子制定质地提高门径。
后果:
在及第的
2013-2019年病院连结体外会诊试剂临床推行的4
235份样本中,共发现质地问题119个,包摄10项问题类型,其主要身分
为推行纪录、推行试剂、有揣摸打算实施、文告尊府、伦理审查及文献和原始纪录6项,次要身分为推行样本1项,一般身分有试
验东说念主员、知情欢跃和统计分析3项,应用鱼骨图分析影响推行质地原因,针对临床推行的3个主要法子制定17条质地晋升措
施。
论断:
应用帕累托图和鱼骨图分析格局,可梳理出常见的体外会诊试剂临床推行质地问题和原因,制定出体外会诊试
剂临床推行质地保证门径,从泉源上确保体外会诊试剂临床推行质地。
[
关键词
] 体外会诊试剂(IVD);临床推行;质地处分;根因分析
DOI: 10.3969/J.ISSN.1672-8270.2021.01.030
李晓华
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