Analysis on the test quality of clinical laboratories in Shanghai by unannounced inspection results

doi:10.3969/j.issn.1673-8640.2018.10.016

Abstract

Abstract:

Objective To evaluate the role of unannounced inspection for assessing the test quality of clinical laboratories in Shanghai organized by Shanghai Center for Clinical Laboratory（SCCL） in 2017,through analyzing the data of unannounced inspection,external quality assessment（EQA） and internal quality control（IQC）. Methods The coefficients of variation（CV） were calculated for the items from the 1st unannounced inspection in 2017 and the quantitative items of EQA. The CV between the 2 programs was evaluated. Results A total of 770 clinical laboratories participated in the programs of unannounced inspection and EQA organized by SCCL. There were 83.33%（85/102） clinical laboratories failed in the unannounced inspection [blood lipid,blood gas and acid-base analysis,blood coagulation,rapid C-reactive protein,rapid blood glucose,homocysteine（Hcy）and tumor markers],but they passed the EQA. The CV were from 0.11% [apolipoprotein B（apo B）] to 52.15% [carbohydrate antigen（CA）19-9],and the average CV was 6.10%,and the CV of unannounced inspection was higher than that of EQA（P=0.014）. Conclusions Clinical laboratories should reserve the primary data of EQA to ensure the truth of EQA,and unannounced inspection could be more useful for reflecting the test quality of clinical laboratories than EQA.

Key words: Clinical laboratory, Unannounced inspection, External quality assessment, Coefficient of variation

CLC Number:

R446.1

YANG Xue, ZHU Jun, YUAN Libin, QIN Fei, LOU Jiao, XU Chong. Analysis on the test quality of clinical laboratories in Shanghai by unannounced inspection results[J]. Laboratory Medicine, 2018, 33(10): 938-942.

计划	调查样品数（个）	调查项目	参加实验室数（家）
血脂	5	apo A1、apo B、HDL-C、LDL-C	356
凝血试验	5	APTT、Fib、PT-INR	253
快速CRP	5	CRP	404
快速血糖	5	Glu	355
血气和酸碱分析	5	p（CO₂）、pH值、p（O₂）	125
Hcy	5	Hcy	207
肿瘤标志物	5	AFP、CEA、TPSA、FPSA、CA125、CA15-3、CA19-9	233

计划	调查样品数（个）	调查项目	参加实验室数（家）
血脂	5	apo A1、apo B、HDL-C、LDL-C	356
凝血试验	5	APTT、Fib、PT-INR	253
快速CRP	5	CRP	404
快速血糖	5	Glu	355
血气和酸碱分析	5	p（CO₂）、pH值、p（O₂）	125
Hcy	5	Hcy	207
肿瘤标志物	5	AFP、CEA、TPSA、FPSA、CA125、CA15-3、CA19-9	233

项目	实验室数（家）	活动	靶值范围	CV（%）	飞行检查与EQA差值的绝对值
apo A1	317	飞行检查	0.97~2.50 g/L	7.83	2.23
		EQA	0.90~2.54 g/L	5.60
apo B	317	飞行检查	0.55~1.58 g/L	6.75	0.11
		EQA	0.54~1.56 g/L	6.64
HDL-C	354	飞行检查	0.50~2.01 mmol/L	10.46	3.80
		EQA	0.57~2.08 mmol/L	6.65
LDL-C	351	飞行检查	1.27~4.49 mmol/L	12.78	3.79
		EQA	1.44~4.35 mmol/L	8.99
APTT	251	飞行检查	27.8~76.7 s	10.25	2.49
		EQA	29.6~72.2 s	7.76
Fib	231	飞行检查	1.33~2.6 g/L	11.35	2.33
		EQA	1.045~2.61 g/L	9.02
PT-INR	249	飞行检查	1.01~3.79	8.49	0.80
		EQA	0.9~3.88	9.30
CRP	404	飞行检查	13.64~79.04 mg/L	8.97	3.41
		EQA	19.26~77 mg/L	5.56
Glu	355	飞行检查	7.9~20.3 mmol/L	10.57	0.95
		EQA	6.4~19.1 mmol/L	9.62
p（CO₂）	125	飞行检查	2.59~8.4 kPa	5.85	1.20
		EQA	2.5~9.5 kPa	7.05
pH值	125	飞行检查	7.16~7.55	0.30	0.19
		EQA	7.14~7.7	0.49
p（O₂）	125	飞行检查	7.4~19 kPa	13.19	6.40
		EQA	9.7~17.95 kPa	6.79
Hcy	207	飞行检查	4.9~29 μmol/L	10.80	3.03
		EQA	5.5~32.4 μmol/L	7.77
AFP	229	飞行检查	20.19~231.61 ng/mL	11.00	2.00
		EQA	8.43~248.82 ng/mL	9.00
CEA	229	飞行检查	6.26~59.3 ng/mL	15.24	5.15
		EQA	6.44~38.94 ng/mL	20.40
TPSA	190	飞行检查	2.85~43.62 ng/mL	12.73	1.25
		EQA	1.96~33.44 ng/mL	11.48
FPSA	169	飞行检查	1.53~22.66 ng/mL	13.57	0.57
		EQA	0.86~14.07 ng/mL	14.14
CA125	216	飞行检查	51.44~372.76 U/mL	21.58	1.05
		EQA	39.61~180.6 U/mL	22.62
CA15-3	197	飞行检查	17.82~36.71 U/mL	45.15	29.14
		EQA	23.76~84.38 U/mL	16.01
CA19-9	214	飞行检查	19.9~162.14 U/mL	72.64	52.15
		EQA	21.54~128.3 U/mL	20.49

项目	实验室数（家）	活动	靶值范围	CV（%）	飞行检查与EQA差值的绝对值
apo A1	317	飞行检查	0.97~2.50 g/L	7.83	2.23
		EQA	0.90~2.54 g/L	5.60
apo B	317	飞行检查	0.55~1.58 g/L	6.75	0.11
		EQA	0.54~1.56 g/L	6.64
HDL-C	354	飞行检查	0.50~2.01 mmol/L	10.46	3.80
		EQA	0.57~2.08 mmol/L	6.65
LDL-C	351	飞行检查	1.27~4.49 mmol/L	12.78	3.79
		EQA	1.44~4.35 mmol/L	8.99
APTT	251	飞行检查	27.8~76.7 s	10.25	2.49
		EQA	29.6~72.2 s	7.76
Fib	231	飞行检查	1.33~2.6 g/L	11.35	2.33
		EQA	1.045~2.61 g/L	9.02
PT-INR	249	飞行检查	1.01~3.79	8.49	0.80
		EQA	0.9~3.88	9.30
CRP	404	飞行检查	13.64~79.04 mg/L	8.97	3.41
		EQA	19.26~77 mg/L	5.56
Glu	355	飞行检查	7.9~20.3 mmol/L	10.57	0.95
		EQA	6.4~19.1 mmol/L	9.62
p（CO₂）	125	飞行检查	2.59~8.4 kPa	5.85	1.20
		EQA	2.5~9.5 kPa	7.05
pH值	125	飞行检查	7.16~7.55	0.30	0.19
		EQA	7.14~7.7	0.49
p（O₂）	125	飞行检查	7.4~19 kPa	13.19	6.40
		EQA	9.7~17.95 kPa	6.79
Hcy	207	飞行检查	4.9~29 μmol/L	10.80	3.03
		EQA	5.5~32.4 μmol/L	7.77
AFP	229	飞行检查	20.19~231.61 ng/mL	11.00	2.00
		EQA	8.43~248.82 ng/mL	9.00
CEA	229	飞行检查	6.26~59.3 ng/mL	15.24	5.15
		EQA	6.44~38.94 ng/mL	20.40
TPSA	190	飞行检查	2.85~43.62 ng/mL	12.73	1.25
		EQA	1.96~33.44 ng/mL	11.48
FPSA	169	飞行检查	1.53~22.66 ng/mL	13.57	0.57
		EQA	0.86~14.07 ng/mL	14.14
CA125	216	飞行检查	51.44~372.76 U/mL	21.58	1.05
		EQA	39.61~180.6 U/mL	22.62
CA15-3	197	飞行检查	17.82~36.71 U/mL	45.15	29.14
		EQA	23.76~84.38 U/mL	16.01
CA19-9	214	飞行检查	19.9~162.14 U/mL	72.64	52.15
		EQA	21.54~128.3 U/mL	20.49

项目	5月			7月
项目	实验室的IQC CV	IQC CV	EQA CV	实验室的IQC CV	IQC CV	飞行检查CV
CRP	7.98	5.71	3.45	6.13	5.63	7.56
p（O₂）	2.53	2.94	2.10	2.52	2.01	7.83
CA19-9	7.38	4.52	4.53	4.64	3.54	5.15

Analysis on the test quality of clinical laboratories in Shanghai by unannounced inspection results

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