Analysis of clinical laboratory quality indicators for Shanghai's tertiary public hospitals from 2020 to 2024

doi:10.3969/j.issn.1673-8640.2026.09.015

Abstract

Abstract:

Objective To analyze the performance of quality indicators across the entire process in clinical laboratories of Shanghai's tertiary public hospitals，and to comprehensively assess the overall testing quality. Methods The data on 15 quality indicators and information system development from 72 tertiary public hospitals' clinical laboratories in Shanghai between 2020 and 2024 were collected. The P₂₅，P₅₀ and P₇₅ values for each indicator，along with their corresponding σ levels and 5-year trends，were calculated. In 2024，the quality levels of these 15 indicators were compared against the quality standards recommended by the International Federation of Clinical Chemistry and Laboratory Medicine（IFCC）Working Group on Laboratory Errors and Patient Safety（WG-LEPS）. Results Among the 72 laboratories，69 laboratories adopted information systems to collect quality data. Among levels of the 15 quality indicators，the P₅₀ values for internal quality control implementation rate and interlaboratory comparison participation rate increased from 96.85% （σ=3.4） and 45.05% （σ=1.6） in 2020 to 98.99% （σ=3.8） and 91.53% （σ=2.9） in 2024，respectively. The medians of pre-analytical turn-around times for inpatient and outpatient specimens decreased from 80 and 30 min in 2020 to 68 and 25 min in 2024. For pre-analytical indicators，the P₅₀ σ levels for specimen type error rate，specimen container error rate，specimen volume error rate and coagulation rate in anticoagulated specimens remained stable at 5.0. The blood culture contamination rate maintained a P₅₀ σ level of 4.0. The median of pre-analytical turn-around time for emergency tests decreased from 23 min in 2020 to 20 min in 2024. For analytical and post-analytical indicators，the P₅₀ σ levels for coefficient of variation failure rate in internal quality control，external quality assessment participation rate，external quality assessment failure rate，incorrect test report rate，critical value notification rate and timely critical value notification rate remained stable at 6.0. The median of laboratory turn-around times for inpatient，emergency and outpatient specimens decreased from 123，52 and 100 min in 2020 to 115，46 and 90 min in 2024，respectively. Except for blood culture contamination rate，more than 80% of laboratories met the minimum quality requirements recommended by IFCC. Conclusions The overall quality performance of clinical laboratories in Shanghai's tertiary public hospitals is excellent and shows an upward trend year by year. However，further strengthening of quality control in the pre-analytical phase remains necessary. Application of quality indicators has improved testing quality，but further enhancement of datum quality requires greater standardization of indicators and higher levels of informationalization in datum collection.

Key words: Clinical laboratory, Laboratory error, Quality indicator, Quality standard

CLC Number:

R197.323.4

YANG Xue, WANG Qing, JIANG Lingli, ZHOU Jing, HU Xiaobo. Analysis of clinical laboratory quality indicators for Shanghai's tertiary public hospitals from 2020 to 2024[J]. Laboratory Medicine, 2026, 41(9): 913-918.

Figures/Tables 5

References 13

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质量指标	最低质量规范	适当的质量规范	最佳的质量规范
标本类型错误率	0.039	0.016	0.003
标本容器错误率	0.019	0.006	0.000
标本采集量错误率	0.070	0.033	0.012
抗凝标本凝集率	0.527	0.240	0.126
血培养污染率	1.256	0.933	0.730
室内质控项目变异系数不合格率	5.519	2.429	0.704
室间质评项目不合格率	2.863	1.881	1.192
检验报告不正确率	0.043	0.020	0.011

质量指标	最低质量规范	适当的质量规范	最佳的质量规范
标本类型错误率	0.039	0.016	0.003
标本容器错误率	0.019	0.006	0.000
标本采集量错误率	0.070	0.033	0.012
抗凝标本凝集率	0.527	0.240	0.126
血培养污染率	1.256	0.933	0.730
室内质控项目变异系数不合格率	5.519	2.429	0.704
室间质评项目不合格率	2.863	1.881	1.192
检验报告不正确率	0.043	0.020	0.011

质量指标	年份	实验室数/家	实验室结果
			百分数/%			σ水平
			P₂₅	P₅₀	P₇₅	P₂₅	P₅₀	P₇₅
检验前阶段
标本类型错误率	2020	65	0	0.004 8	0.010 8	5.2	5.4	6.0
	2021	65	0.000 8	0.004 1	0.008 3	5.3	5.4	5.8
	2022	64	0.000 7	0.003 6	0.013 0	5.2	5.5	5.8
	2023	70	0.000 7	0.004 1	0.009 7	5.2	5.4	5.8
	2024	72	0.000 7	0.003 7	0.010 1	5.2	5.5	5.8
标本容器错误率	2020	64	0.000 2	0.003 2	0.012 3	5.2	5.5	6.1
	2021	64	0.000 9	0.003 1	0.008 9	5.2	5.5	5.8
	2022	63	0.001 0	0.004 3	0.009 0	5.2	5.4	5.8
	2023	70	0.000 3	0.004 0	0.011 3	5.2	5.4	6.0
	2024	72	0.000 8	0.004 1	0.009 9	5.2	5.4	5.8
标本采集量错误率	2020	64	0.001 1	0.010 9	0.021 9	5.0	5.2	5.7
	2021	64	0.004 1	0.012 6	0.024 6	5.0	5.2	5.4
	2022	63	0.004 0	0.012 8	0.027 0	5.0	5.2	5.4
	2023	70	0.002 4	0.013 7	0.027 3	5.0	5.1	5.6
	2024	72	0.002 6	0.011 0	0.021 4	5.0	5.2	5.5
抗凝标本凝集率	2020	63	0.020 3	0.038 9	0.084 2	4.6	4.9	5.0
	2021	64	0.015 0	0.046 2	0.103 9	4.6	4.8	5.1
	2022	63	0.013 5	0.045 5	0.091 7	4.6	4.8	5.1
	2023	70	0.004 4	0.026 0	0.079 1	4.7	5.0	5.4
	2024	70	0.005 8	0.030 3	0.060 5	4.7	4.9	5.4
血培养污染率	2020	54	0	0.683 1	1.371 8	3.7	4.0	6.0
	2021	60	0.218 1	0.645 8	0.935 6	3.9	4.0	4.4
	2022	60	0.455 7	1.016 3	1.638 2	3.6	3.8	4.1
	2023	64	0.250 2	0.789 3	1.389 5	3.7	3.9	4.3
	2024	65	0.211 9	0.683 0	1.207 3	3.8	4.0	4.4
检验阶段
室内质控项目开展率	2020	62	89.750 0	96.850 0	100.000 0	2.8	3.4	6.0
	2021	64	91.650 0	98.950 0	100.000 0	2.9	3.8	6.0
	2022	63	90.410 0	98.890 0	100.000 0	2.8	3.8	6.0
	2023	70	86.720 0	95.690 0	100.000 0	2.6	3.2	6.0
	2024	72	91.770 0	98.990 0	100.000 0	2.9	3.8	6.0
室内质控项目变异系数不合格率	2020	60	0	0	3.860 0	3.3	6.0	6.0
	2021	63	0	0	2.860 0	3.4	6.0	6.0
	2022	62	0	0	1.660 0	3.6	6.0	6.0
	2023	69	0	0	0.330 0	4.2	6.0	6.0
	2024	70	0	0	0.630 0	4.0	6.0	6.0
室间质评项目参加率	2020	55	97.980 0	100.000 0	100.000 0	3.5	6.0	6.0
	2021	65	100.000 0	100.000 0	100.000 0	6.0	6.0	6.0
	2022	57	100.000 0	100.000 0	100.000 0	6.0	6.0	6.0
	2023	70	100.000 0	100.000 0	100.000 0	6.0	6.0	6.0
	2024	72	100.000 0	100.000 0	100.000 0	6.0	6.0	6.0
室间质评项目不合格率	2020	60	0	0	0	6.0	6.0	6.0
	2021	65	0	0	0.160 0	4.4	6.0	6.0
	2022	64	0	0	0	6.0	6.0	6.0
	2023	70	0	0	0.310 0	4.2	6.0	6.0
	2024	72	0	0	0	6.0	6.0	6.0
实验室间比对率	2020	53	24.730 0	45.050 0	83.750 0	2.2	1.6	0.5
	2021	60	31.710 0	74.850 0	100.000 0	1.0	2.2	6.0
	2022	60	41.830 0	88.740 0	100.000 0	1.3	2.7	6.0
	2023	66	50.880 0	91.210 0	100.000 0	1.5	2.9	6.0
	2024	69	61.610 0	91.530 0	100.000 0	1.8	2.9	6.0
检验报告不正确率	2020	63	0	0	0	6.0	6.0	6.0
	2021	64	0	0	0.000 8	5.8	6.0	6.0
	2022	64	0	0	0.002 1	5.6	6.0	6.0
	2023	69	0	0	0.003 6	5.5	6.0	6.0
	2024	72	0	0	0.002 0	5.6	6.0	6.0
检验后阶段
危急值通报率	2020	61	100.000 0	100.000 0	100.000 0	6.0	6.0	6.0
	2021	63	100.000 0	100.000 0	100.000 0	6.0	6.0	6.0
	2022	61	100.000 0	100.000 0	100.000 0	6.0	6.0	6.0
	2023	70	100.000 0	100.000 0	100.000 0	6.0	6.0	6.0
	2024	72	100.000 0	100.000 0	100.000 0	6.0	6.0	6.0
危急值通报及时率	2020	61	100.000 0	100.000 0	100.000 0	6.0	6.0	6.0
	2021	63	99.930 0	100.000 0	100.000 0	4.7	6.0	6.0
	2022	61	99.750 0	100.000 0	100.000 0	4.3	6.0	6.0
	2023	70	97.840 0	100.000 0	100.000 0	3.5	6.0	6.0
	2024	72	99.650 0	100.000 0	100.000 0	4.2	6.0	6.0

质量指标	年份	实验室数/家	实验室结果
			百分数/%			σ水平
			P₂₅	P₅₀	P₇₅	P₂₅	P₅₀	P₇₅
检验前阶段
标本类型错误率	2020	65	0	0.004 8	0.010 8	5.2	5.4	6.0
	2021	65	0.000 8	0.004 1	0.008 3	5.3	5.4	5.8
	2022	64	0.000 7	0.003 6	0.013 0	5.2	5.5	5.8
	2023	70	0.000 7	0.004 1	0.009 7	5.2	5.4	5.8
	2024	72	0.000 7	0.003 7	0.010 1	5.2	5.5	5.8
标本容器错误率	2020	64	0.000 2	0.003 2	0.012 3	5.2	5.5	6.1
	2021	64	0.000 9	0.003 1	0.008 9	5.2	5.5	5.8
	2022	63	0.001 0	0.004 3	0.009 0	5.2	5.4	5.8
	2023	70	0.000 3	0.004 0	0.011 3	5.2	5.4	6.0
	2024	72	0.000 8	0.004 1	0.009 9	5.2	5.4	5.8
标本采集量错误率	2020	64	0.001 1	0.010 9	0.021 9	5.0	5.2	5.7
	2021	64	0.004 1	0.012 6	0.024 6	5.0	5.2	5.4
	2022	63	0.004 0	0.012 8	0.027 0	5.0	5.2	5.4
	2023	70	0.002 4	0.013 7	0.027 3	5.0	5.1	5.6
	2024	72	0.002 6	0.011 0	0.021 4	5.0	5.2	5.5
抗凝标本凝集率	2020	63	0.020 3	0.038 9	0.084 2	4.6	4.9	5.0
	2021	64	0.015 0	0.046 2	0.103 9	4.6	4.8	5.1
	2022	63	0.013 5	0.045 5	0.091 7	4.6	4.8	5.1
	2023	70	0.004 4	0.026 0	0.079 1	4.7	5.0	5.4
	2024	70	0.005 8	0.030 3	0.060 5	4.7	4.9	5.4
血培养污染率	2020	54	0	0.683 1	1.371 8	3.7	4.0	6.0
	2021	60	0.218 1	0.645 8	0.935 6	3.9	4.0	4.4
	2022	60	0.455 7	1.016 3	1.638 2	3.6	3.8	4.1
	2023	64	0.250 2	0.789 3	1.389 5	3.7	3.9	4.3
	2024	65	0.211 9	0.683 0	1.207 3	3.8	4.0	4.4
检验阶段
室内质控项目开展率	2020	62	89.750 0	96.850 0	100.000 0	2.8	3.4	6.0
	2021	64	91.650 0	98.950 0	100.000 0	2.9	3.8	6.0
	2022	63	90.410 0	98.890 0	100.000 0	2.8	3.8	6.0
	2023	70	86.720 0	95.690 0	100.000 0	2.6	3.2	6.0
	2024	72	91.770 0	98.990 0	100.000 0	2.9	3.8	6.0
室内质控项目变异系数不合格率	2020	60	0	0	3.860 0	3.3	6.0	6.0
	2021	63	0	0	2.860 0	3.4	6.0	6.0
	2022	62	0	0	1.660 0	3.6	6.0	6.0
	2023	69	0	0	0.330 0	4.2	6.0	6.0
	2024	70	0	0	0.630 0	4.0	6.0	6.0
室间质评项目参加率	2020	55	97.980 0	100.000 0	100.000 0	3.5	6.0	6.0
	2021	65	100.000 0	100.000 0	100.000 0	6.0	6.0	6.0
	2022	57	100.000 0	100.000 0	100.000 0	6.0	6.0	6.0
	2023	70	100.000 0	100.000 0	100.000 0	6.0	6.0	6.0
	2024	72	100.000 0	100.000 0	100.000 0	6.0	6.0	6.0
室间质评项目不合格率	2020	60	0	0	0	6.0	6.0	6.0
	2021	65	0	0	0.160 0	4.4	6.0	6.0
	2022	64	0	0	0	6.0	6.0	6.0
	2023	70	0	0	0.310 0	4.2	6.0	6.0
	2024	72	0	0	0	6.0	6.0	6.0
实验室间比对率	2020	53	24.730 0	45.050 0	83.750 0	2.2	1.6	0.5
	2021	60	31.710 0	74.850 0	100.000 0	1.0	2.2	6.0
	2022	60	41.830 0	88.740 0	100.000 0	1.3	2.7	6.0
	2023	66	50.880 0	91.210 0	100.000 0	1.5	2.9	6.0
	2024	69	61.610 0	91.530 0	100.000 0	1.8	2.9	6.0
检验报告不正确率	2020	63	0	0	0	6.0	6.0	6.0
	2021	64	0	0	0.000 8	5.8	6.0	6.0
	2022	64	0	0	0.002 1	5.6	6.0	6.0
	2023	69	0	0	0.003 6	5.5	6.0	6.0
	2024	72	0	0	0.002 0	5.6	6.0	6.0
检验后阶段
危急值通报率	2020	61	100.000 0	100.000 0	100.000 0	6.0	6.0	6.0
	2021	63	100.000 0	100.000 0	100.000 0	6.0	6.0	6.0
	2022	61	100.000 0	100.000 0	100.000 0	6.0	6.0	6.0
	2023	70	100.000 0	100.000 0	100.000 0	6.0	6.0	6.0
	2024	72	100.000 0	100.000 0	100.000 0	6.0	6.0	6.0
危急值通报及时率	2020	61	100.000 0	100.000 0	100.000 0	6.0	6.0	6.0
	2021	63	99.930 0	100.000 0	100.000 0	4.7	6.0	6.0
	2022	61	99.750 0	100.000 0	100.000 0	4.3	6.0	6.0
	2023	70	97.840 0	100.000 0	100.000 0	3.5	6.0	6.0
	2024	72	99.650 0	100.000 0	100.000 0	4.2	6.0	6.0

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