中国输血杂志2025，Vol.38Issue(11)：1521-1528,1591,9.DOI:10.13303/j.cjbt.issn.1004-549x.2025.11.007
华北地区血站实验室检测前标本质量不合格情况分析
Analysis of unqualified pre-analytical samples in blood station laboratories in North China
刘正敏 1葛红卫 1秦倩倩 1韩卫 2潘彤 3焦东丽 4董效兰 5王瑞1
作者信息
- 1. 北京市红十字血液中心,北京 100088
- 2. 河北省血液中心,河北 石家庄 050000
- 3. 天津市血液中心,天津 300074
- 4. 山西省血液中心,山西 太原 030012
- 5. 内蒙古自治区血液中心,内蒙古 呼和浩特 010050
- 折叠
摘要
Abstract
Objective To determine the frequency and main reasons of unqualified samples by analyzing the quality of pre-analytical samples in blood stations in North China,thereby providing a reference and basis for gap analysis in the im-plementation of pre-analytical process quality management for participating laboratories and ensuring that only high-standard and high-quality blood samples proceed to testing.Methods Data on the quality of pre-analytical samples from blood sta-tion laboratories in North China was collected via questionnaire.Statistical analysis were performed on:1)the basic informa-tion of samples quality monitoring in the laboratories;2)the distribution of the overall pre-analytical unqualified rate of sam-ples and the pre-analytical unqualified rate of samples in each laboratory;3)the distribution of reasons for sample disquali-fication.Results 1)The overall pre-analytical unqualified rate of samples in blood station laboratories in North China was 4.55‱,with a total sigma level of 5.39σ.The 25th,50th and 75th percentiles(P25,P50,P75)for the total unqualified rate were 0.00‱,1.10‱and 5.96‱,respectively.The corresponding percentiles for the Sigma level were 5.34σ,5.71σ,and 6.00σ,respectively.The pre-analytical unqualified rate of serological and nucleic acid samples(4.89‱ vs 4.22‱)showed a significant difference(x2=9.575,P<0.05).2)The average unqualified rate of samples in region A,B and C was 1.71‱,9.50‱ and 12.64‱(x2=1 590.721,P<0.05),and the sigma level was 5.66σ,5.21σ and 5.16σ,respec-tively.3)The main reasons for unqualified serological samples were chylous blood(72.65%),hemolysis(17.39%),ab-normal hematocrit(5.80%),and insufficient volume(3.50%).The main reasons for the unqualified nucleic acid samples were chylous blood(78.26%),hemolysis(8.84%),failure to centrifuge as required(5.01%),abnormal hematocrit(4.66%),and insufficient volume(1.92%).Conclusion In North China,the quality indicators for the pre-analytical processes in blood station laboratories are generally well-managed.Laboratories in region A outperformed the national aver-age in pre-analytical specimen quality control.However,participating laboratories exhibit gaps in implementing pre-analyti-cal quality management.Through effective analysis of pre-analytical process quality metrics and inter-laboratory compari-sons,laboratories can identify discrepancies and address shortcomings.By establishing clear quality objectives,they can a-chieve continuous improvement and ensure the validity of test results.关键词
检测前标本/血站实验室/西格玛/百分位数Key words
pre-analytical samples/blood station laboratory/Sigma/percentile分类
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刘正敏,葛红卫,秦倩倩,韩卫,潘彤,焦东丽,董效兰,王瑞..华北地区血站实验室检测前标本质量不合格情况分析[J].中国输血杂志,2025,38(11):1521-1528,1591,9.
