Analysis of unqualified pre-analytical samples in blood station laboratories in North China
10.13303/j.cjbt.issn.1004-549x.2025.11.007
- VernacularTitle:华北地区血站实验室检测前标本质量不合格情况分析
- Author:
Zhengmin LIU
1
;
Hongwei GE
1
;
Qianqian QIN
1
;
Wei HAN
2
;
Tong PAN
3
;
Dongli JIAO
4
;
Xiaolan DONG
5
;
Rui WANG
1
Author Information
1. Beijing Red Cross Blood Center, Beijing 100088, China
2. Hebei Blood Center, Shijiazhuang 050000, China
3. Tianjin Blood Center, Tianjin 300074, China
4. Shanxi Blood Center, Taiyuan 030012, China
5. Inner Mongolia Autonomous Region Blood Center, Huhehot 010050, China
- Publication Type:Journal Article
- Keywords:
pre-analytical samples;
blood station laboratory;
Sigma;
percentile
- From:
Chinese Journal of Blood Transfusion
2025;38(11):1521-1528
- CountryChina
- Language:Chinese
-
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 implementation 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 station laboratories in North China was collected via questionnaire. Statistical analysis were performed on: 1) the basic information of samples quality monitoring in the laboratories; 2) the distribution of the overall pre-analytical unqualified rate of samples and the pre-analytical unqualified rate of samples in each laboratory; 3) the distribution of reasons for sample disqualification. 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 (χ
=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 (χ
=1 590.721, P<0.05), and the sigma level was 5.66σ, 5.21σ and 5.16σ, respectively. 3) The main reasons for unqualified serological samples were chylous blood (72.65%), hemolysis (17.39%), abnormal 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 average in pre-analytical specimen quality control. However, participating laboratories exhibit gaps in implementing pre-analytical quality management. Through effective analysis of pre-analytical process quality metrics and inter-laboratory comparisons, laboratories can identify discrepancies and address shortcomings. By establishing clear quality objectives, they can achieve continuous improvement and ensure the validity of test results.
