凝血检验自动审核问题与对策

doi:10.3969/j.issn.1673-8640.2022.06.018

摘要/Abstract

摘要：

检验报告自动审核可显著缩短实验室内样本周转时间,提高工作效率,是检验科未来发展的趋势。凝血试验自动审核常面临不合格样本识别难、自动审核规则设计复杂等诸多问题。严格、规范的分析前质量控制和信息系统互联互通是实施凝血试验自动审核的基础。实验室应根据自身条件设定合适的凝血试验自动审核规则,以结果准确为前提,并持续优化,逐步提高检验报告自动审核通过率。

关键词: 自动审核, 凝血试验, 实验室信息系统, 实验室自动化

Abstract:

The autoverification of reports is the future development trend of clinical laboratories,which can significantly shorten the laboratory sample turn-around time and improve work efficiency. The autoverification of coagulation tests is less used in clinical laboratories,due to many problems such as the identification of unqualified samples and the complex rules of autoverification. The basis for the implementation of autoverification is strict and standardized quality control of pre-analysis and interconnection of information systems. Based on the premise of accurate results,clinical laboratories can set appropriate autoverification rules according to its own conditions,continuously optimize the autoverification rules for coagulation test,and gradually increase the autoverification pass rate of clinical laboratory test.

Key words: Autoverification, Coagulation test, Laboratory information system, Laboratory automation

中图分类号:

R446.11

范庆坤, 李玲, 杜佳, 杨军, 张真路. 凝血检验自动审核问题与对策[J]. 检验医学, 2022, 37(6): 596-600.

FAN Qingkun, LI Ling, DU Jia, YANG Jun, ZHANG Zhenlu. Problems and solutions on autoverification of coagulation test[J]. Laboratory Medicine, 2022, 37(6): 596-600.

图/表 4

参考文献 18

[1]	SALVAGNO G L, DANESE E, LIPPI G. Mass spectrometry and total laboratory automation:opportunities and drawbacks[J]. Clin Chem Lab Med, 2020, 58(6):994-1001.
[2]	RANDELL E W, YENICE S, KHINE WAMONO A A, et al. Autoverification of test results in the core clinical laboratory[J]. Clin Biochem, 2019,73:11-25.
[3]	Clinical and Laboratory Standards Institute. Autoverification of clinical laboratory test results[S]. AUTO10-A,CLSI, 2006.
[4]	Clinical and Laboratory Standards Institute. Autoverification of medical laboratory results for specific disciplines[S]. AUTO15,CLSI, 2019.
[5]	中华人民共和国国家卫生健康委员会. WS/T 616—2018 临床实验室定量检验结果的自动审核[S]. 北京: 中华人民共和国国家卫生健康委员会, 2018.
[6]	ZHAO Y, YANG L, ZHENG G, et al. Building and evaluating the autoverification of coagulation items in the laboratory information system[J]. Clin Lab, 2014, 60(1):143-150.
[7]	ONELÖV L, GUSTAFSSON E, GRÖNLUND E, et al. Autoverification of routine coagulation assays in a multi-center laboratory[J]. Scand J Clin Lab Invest, 2016, 76(6):500-502.
[8]	曲林琳, 吴俊, 吴卫, 等. 凝血检验结果自动审核规则建立与验证的多中心研究[J]. 中华检验医学杂志, 2020, 43(8):802-811.
[9]	李玲, 杜佳, 赵耿生, 等. 凝血试验自动审核方案的建立与临床应用[J]. 临床检验杂志, 2021, 39(7):534-538.
[10]	LIPPI G, SALVAGNO G L, MONTAGNANA M, et al. Quality standards for sample collection in coagulation testing[J]. Semin Thromb Hemost, 2012, 38(6):565-575.
[11]	高志琪, 苑惠敏, 周琪, 等. 止凝血检验分析前标本质量自动核查的应用评估[J]. 中华检验医学杂志, 2019, 42(11):962-966.
[12]	FERNÁNDEZ-GRANDE E, VALERA-RODRIGUEZ C, SÁENZ-MATEOS L, et al. Impact of reference change value(RCV)based autoverification on turnaround time and physician satisfaction[J]. Biochem Med(Zagreb), 2017, 27(2):342-349.
[13]	MLINARIC A, MILOS M, COEN HERAK D, et al. Autovalidation and automation of the postanalytical phase of routine hematology and coagulation analyses in a university hospital laboratory[J]. Clin Chem Lab Med, 2018, 56(3):454-462.
[14]	MARLAR R A, STRANDBERG K, SHIMA M, et al. Clinical utility and impact of the use of the chromogenic vs one-stage factor activity assays in haemophilia A and B[J]. Eur J Haematol, 2020, 104(1):3-14.
[15]	JENNINGS I, KITCHEN D, KITCHEN S, et al. The importance of commutability in material used for quality control purposes[J]. Int J Lab Hematol, 2019, 41(1):39-45.
[16]	王尉, 秦妍妍, 尹弘毅, 等. 采用室间质评数据建立常规凝血项目的目标测量不确定度[J]. 中华检验医学杂志, 2017, 40(12):942-946.
[17]	WANG Z, PENG C, KANG H, et al. Design and evaluation of a lis-based autoverification system for coagulation assays in a core clinical laboratory[J]. BMC Med Inform Decis Mak, 2019, 19(1):123.
[18]	范庆坤, 杨军, 张真路. 如何协助诊断肝素诱导血小板减少症并监测其治疗?[J]. 临床检验杂志, 2019, 37(9):657-660.

序号	组合	适用人群
1	PT/INR,DD	口服华法林患者
2	APTT,AT,Anti-Xa	肝素治疗患者
3	Anti-Xa,AT	大剂量肝素治疗患者
4	PT,Anti-Xa（谷值）/峰值	利伐沙班/艾多沙班治疗患者
5	APTT,TT	直接凝血酶抑制剂治疗患者
6	PT/INR,APTT,Fib,DD	新入院患者或术后患者
7	PT/INR,APTT,TT,Fib,AT,凝血因子VIII	新入院患者
8	PT/INR,APTT,Fib,DD,anti-Xa	体外生命辅助设备治疗患者
9	PT/INR,APTT,TT,Fib,AT,凝血因子VIII,FDP,DD	心脏移植或心外科手术患者
10	FDP,DD	血栓风险评估患者
11	TAT,DD	血栓风险评估,阿加曲班或比伐卢定疗效评估患者

序号	组合	适用人群
1	PT/INR,DD	口服华法林患者
2	APTT,AT,Anti-Xa	肝素治疗患者
3	Anti-Xa,AT	大剂量肝素治疗患者
4	PT,Anti-Xa（谷值）/峰值	利伐沙班/艾多沙班治疗患者
5	APTT,TT	直接凝血酶抑制剂治疗患者
6	PT/INR,APTT,Fib,DD	新入院患者或术后患者
7	PT/INR,APTT,TT,Fib,AT,凝血因子VIII	新入院患者
8	PT/INR,APTT,Fib,DD,anti-Xa	体外生命辅助设备治疗患者
9	PT/INR,APTT,TT,Fib,AT,凝血因子VIII,FDP,DD	心脏移植或心外科手术患者
10	FDP,DD	血栓风险评估患者
11	TAT,DD	血栓风险评估,阿加曲班或比伐卢定疗效评估患者

项目	单位	自动审核规则		备注
项目	单位	自动审核区间值	差值检查（变化值/d）	备注
PT	s	≤200.0^①	300%/2^①
		10.0~21.0^②	<10 s/10^②	抗凝治疗患者
		11.0~16.3^③	15%/15^④
		9.7~15.6^⑤	14%/7^⑤
INR		0.8~4.0^①④	15%/15^④
		2.0~3.0^②	30^②	抗凝治疗患者
		0.8~4.5^⑥	14%/7^⑤
APTT	s	26.0~45.0^①	≥45%/1^①	APTT-R为0.87~1.50
		22.4~44.0^②
		20.4~46.4^③
		22.0~40.0^④	13%/15^④
		25.0~50.0^⑥
		23.9~36.9（FSL）^⑤	10%/7^⑤
		21.5~36.7（ACTIN）^⑤
Fib	g/L	1.80~5.00^①		Fib（PT演算法）/Fib（Clauss法）>2 g/L,人工审核
		1.00~4.96^②
		2.00~6.50^③
		1.80~7.10^④	30%/15^④
		1.50~4.50^⑥
		1.50~6.90^⑤	32%/7^⑤
T T	s	10.0~20.0^①	300%/2^①
		14.0~21.0^③
		10.0~30.0^④	15%/15^④
		13.6~21.4^⑤	31%/7^⑤
AT	%	70.0~150.0^①	100%/2^①
		50.0~125.0^④	24%/15^④
DD	μg/mL	≤1.00^①	500%/2^①
		0.10~1.50^⑥	66%/7^⑤
FDP	μg/mL	≤120.0^①		FDP/DD为1.5~8.0
凝血因子Ⅷ	%	70.0~250.0^①	100%/2^①
抗-Ⅹa	U/mL	≤0.70^①	200%/2^①

项目	单位	自动审核规则		备注
项目	单位	自动审核区间值	差值检查（变化值/d）	备注
PT	s	≤200.0^①	300%/2^①
		10.0~21.0^②	<10 s/10^②	抗凝治疗患者
		11.0~16.3^③	15%/15^④
		9.7~15.6^⑤	14%/7^⑤
INR		0.8~4.0^①④	15%/15^④
		2.0~3.0^②	30^②	抗凝治疗患者
		0.8~4.5^⑥	14%/7^⑤
APTT	s	26.0~45.0^①	≥45%/1^①	APTT-R为0.87~1.50
		22.4~44.0^②
		20.4~46.4^③
		22.0~40.0^④	13%/15^④
		25.0~50.0^⑥
		23.9~36.9（FSL）^⑤	10%/7^⑤
		21.5~36.7（ACTIN）^⑤
Fib	g/L	1.80~5.00^①		Fib（PT演算法）/Fib（Clauss法）>2 g/L,人工审核
		1.00~4.96^②
		2.00~6.50^③
		1.80~7.10^④	30%/15^④
		1.50~4.50^⑥
		1.50~6.90^⑤	32%/7^⑤
T T	s	10.0~20.0^①	300%/2^①
		14.0~21.0^③
		10.0~30.0^④	15%/15^④
		13.6~21.4^⑤	31%/7^⑤
AT	%	70.0~150.0^①	100%/2^①
		50.0~125.0^④	24%/15^④
DD	μg/mL	≤1.00^①	500%/2^①
		0.10~1.50^⑥	66%/7^⑤
FDP	μg/mL	≤120.0^①		FDP/DD为1.5~8.0
凝血因子Ⅷ	%	70.0~250.0^①	100%/2^①
抗-Ⅹa	U/mL	≤0.70^①	200%/2^①