[1]张淑俊,袁 薇,孙建超,等.2020~~2022 年贵州省临床实验室常规生化项目应用批长度Westgard 西格玛规则的室内质量控制策略分析[J].现代检验医学杂志,2024,39(02):184-191.[doi:10.3969/j.issn.1671-7414.2024.02.034]
　ZHANG Shujun,YUAN Wei,SUN Jianchao,et al.Analysis of Internal Quality Control Strategies for the Application of Batch Length Westgard Sigma Rules in Routine Biochemical Projects of Clinical Laboratories in Guizhou Province from 2020 to 2022[J].Journal of Modern Laboratory Medicine,2024,39(02):184-191.[doi:10.3969/j.issn.1671-7414.2024.02.034]
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2020~~2022 年贵州省临床实验室常规生化项目应用批长度Westgard 西格玛规则的室内质量控制策略分析()
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《现代检验医学杂志》[ISSN:/CN:]

卷:
第39卷
期数:
2024年02期
页码:
184-191
栏目:
质量控制·实验室管理
出版日期:
2024-03-31

文章信息/Info

Title:
Analysis of Internal Quality Control Strategies for the Application of Batch Length Westgard Sigma Rules in Routine Biochemical Projects of Clinical Laboratories in Guizhou Province from 2020 to 2022
文章编号:
1671-7414（2024）02-184-08
作者:
张淑俊1; 袁 薇1; 2; 3; 孙建超2; 杨敬源1; 李 梅1; 张娜佳2
（1. 贵州医科大学公共卫生与健康学院，环境污染与疾病监控教育部重点实验室，贵阳 561113；2. 贵州省临床检验中心质量管理科，贵阳 550002；3. 贵州省疾病预防控制中心，贵阳 550004）
Author(s):
ZHANG Shujun1;  YUAN Wei1; 2; 3;  SUN Jianchao2;  YANG Jingyuan1;  LI Mei1;  ZHANG Najia2
（1. School of Public Health, the Key Laboratory of Environmental Pollution Monitoring and Disease Control, Ministry of Education Guizhou Medical University, Guiyang 561113, China; 2. Guizhou Provincial Clinical Laboratory, Guiyang 550002, China; 3.Guizhou Provincial Center for Disease Control and Prevention, Guiyang 550004, China）
关键词:
室内质量控制; Westgard 西格玛规则; 质量目标指数; 质控规则
分类号:
R446
DOI:
10.3969/j.issn.1671-7414.2024.02.034
文献标志码:
A
摘要:
目的　了解2020~2022 年贵州省常规生化项目室内质量控制（internal quality control，IQC）情况，并运用分析批长度西格玛规则为常规生化项目选择恰当的IQC 策略。方法　从参加2020~2022 年贵州省临床检验中心常规生化项目第一次室间质量评价（external quality assessment，EQA）计划的实验室中筛选出统一采用英国朗道公司生产的两个浓度水平室内质控品的41 家、41 家和52 家实验室，根据其IQC 信息计算变异系数（coefficient of variation，CV），将CV 与WS/T403-2012 标准等不精密度性能规范进行比较，分析近年来贵州省常规生化项目的IQC 情况；每年从中随机抽取15家回报三酰甘油项目结果的实验室并计算σ 值，根据分析批长度Westgard 西格玛规则流程图为其选择合适的质控策略，计算质量目标指数（quality goal index，QGI）以评价各实验室检测系统的分析性能。结果　当月CV 中，Ca，TP 2 个项目满足WS/T403-2012 标准的实验室比例较低，而P，CK，LDH 等7 个项目通过率均在80％以上，且呈逐年上升趋势；P，CK，LDH 等7 个项目符合生物医学变异（适当）性能规范的实验室比例均达90％，但Na，Ca，Cl 等5 个项目比例较低。累积CV 中P，CK，LDH 等10 个项目满足生物医学变异（适当）性能规范的实验室比例在90％以上。对于三酰甘油项目，2020 年~2022 年分别有2 家、5 家、13 家实验室达到6σ 水平；与2020 年和2021 年相比，2022 年σ 值变化趋势上升（t=3.855，3.511，P ≤ 0.001），表明这些实验室分析性能越来越好。结论　贵州省部分常规生化项目的IQC 水平在逐年提升。分析批长度Westgard 西格玛规则为贵州省各实验室设计个性化质控规则，提高实验室的检测能力，更好地服务临床。
Abstract:
Objective　To understand the internal quality control (IQC) situation of routine biochemical projects in Guizhou Province from 2020 to 2022, and to use the analysis batch length sigma rule to select the appropriate IQC strategy for routine biochemical projects. Methods　A sum of 41, 41 and 52 laboratories were selected from the laboratories participating in the first external quality assessment (EQA) program of the routine biochemical project in the Guizhou Provincial Center for Clinical Laboratory from 2020 to 2022, which uniformly used two concentration levels of internal quality control products produced by Randox Company in the UK. The coefficient of variation (CV) was calculated based on their IQC information, and then these CV values were used to compare with imprecise performance specifications such as WS/T403-2012 standards. The IQC situation of routine biochemical projects of Guizhou Province in recent years was analyzed. Randomly 15 laboratories were selected each year to report the results of the triglyceride project, and their σ values were calculated. Based on the Westgard sigma rule flowcharts of the analysis batch length, appropriate quality control strategies were selected and the quality goal index (QGI) was calculated to evaluate analytical performance of laboratory detection system. Results　In the current monthly CV, the proportion of laboratories that met the WS/T403-2012 standards for Ca and TP projects was relatively low, while the pass rates for 7 projects (P, CK, LDH and other projects) were all above 80%, showing an increasing trend year by year. The proportion of laboratories with the 7 projects (P, CK, LDH and other projects) meeting the performance specifications for biomedical variation (appropriate) all reached 90%, while the proportion of laboratories with 5 projects (Na, Ca, Cl and other projects) was relatively low. The proportion of 10 projects such as P, CK, and LDH in cumulative CV of laboratories that met the performance specifications for biomedical variation (appropriate) was over 90%. For the triglyceride project, from 2020 to 2022, there were 2, 5 and 13 laboratories that reached 6 σ horizontal. Compared to values of 2020 and 2021 years, the trend of σ values changes of 2022 was increasing (t=3.855, 3.511, P ≤ 0.001), indicating that the analytical performance of these laboratories was getting better and better. Conclusion　The IQC levels of routine biochemical projects in Guizhou Province were increasing year by year. The Westgard sigma rule of the analysis batch length is designed with personalized quality control rules for various laboratories in Guizhou Province, thus improving laboratory testing capabilities and better severing clinics.

参考文献/References:

[1] 赵海建, 张传宝, 王薇, 等. 脂类检验项目室内质控变异系数分析[J]. 中华检验医学杂志, 2012, 35(12):1172-1175. ZHAO Haijian, ZHANG Chuanbao, WANG Wei, et al. Analysis of the coefficient of variation of internal quality control of lipid testing[J]. Chinese Journal of Laboratory Medicine, 2012, 35(12): 1172-1175.
[2] 周晓艳, 李越, 何谦, 等. 不同基因型HCV 感染患者血清Lp(a) 水平检测分析[J]. 现代检验医学杂志,2018, 33(1): 49-51. ZHOU Xiaoyan, LI Yue, HE Qian, et al. Analysis of serum Lp(a) levels in patients with different genotypes of HCV infection[J]. Journal of Modern Laboratory Medicine, 2018, 33(1): 49-51.
[3] 徐晓华, 孔丽蕊. 分析批长度Westgard 西格玛规则图在甲状腺功能检查项目质控中的应用[J]. 现代检验医学杂志, 2019, 34(3): 156-157. XU Xiaohua, KONG Lirui. The application of Westgard sigma rule chart of analysis batch in quality control of thyroid function examination items[J]. Journal of Modern Laboratory Medicine, 2019, 34(3): 156-157.
[4] 蒋玲丽, 朱俊, 娄娇, 等. 上海市临床实验室13 个常规化学检测结果互认项目检测质量分析[J]. 现代检验医学杂志, 2021, 36(4): 162-166. JIANG Lingli, ZHU Jun, LOU Jiao, et al. Analysis of mutual recognition items of 13 routine biochemistry in Shanghai medical laboratories[J]. Journal of Modern Laboratory Medicine, 2021, 36(4): 162-166.
[5] 李伟强, 周通, 彰金, 等. 分析批长度Westgard 西格玛规则图在肿瘤标志物质控策略中的应用[J]. 标记免疫分析与临床, 2021, 28(4): 687-691. LI Weiqiang, ZHOU Tong, ZHANG Jin, et al. The application of Westgard sigma rules of analysis batch in optimizing quality control strategy of tumor markers[J].Labeled Immunoassays and Clinical Medicine, 2021,28(4): 687-691.
[6] 刘倩, 杨伏猛, 姚丽, 等. 六西格玛在凝血项目质量控制方面的应用及改进[J]. 国际医药卫生导报,2020, 26(13): 1854-1857. LIU Qian, YANG Fumeng, YAO Li, et al. Application and improvement of six sigma in quality control of coagulation analytes[J]. International Medicine and Health Guidance News, 2020, 26(13): 1854-1857.
[7] 胡江红, 袁平宗, 汤雪彪, 等. 应用六西格玛性能验证图对18 个常规化学项目的性能评价[J]. 现代检验医学杂志, 2018, 33(6): 161-164. HU Jianghong, YUAN Pingzong, TANG Xuebiao, et al. Performance evaluation of 18 conventional chemical projects using six sigma performance verification diagram[J]. Journal of Modern Laboratory Medicine,2018, 33(6): 161-164.
[8] 宋廷将, 吴世满. 人脐带间充质干细胞注射液治疗尘肺病的作用及机制研究[J]. 职业与健康, 2022,38(18): 2475-2479, 2485. SONG Tingjiang, WU Shiman. Effect and mechanism of human umbilical cord mesenchymal stem cell injection on pneumoconiosis[J]. Occupation and Health, 2022, 38(18): 2475-2479, 2485.
[9] 刘佳丽, 王薇, 何法霖, 等. 脑脊液生化检测室内质量控制不精密度分析及Westgard 西格玛规则的应用[J]. 现代检验医学杂志, 2018, 33(3): 154-157. LIU Jiali, WANG Wei, HE Falin, et al. Ana1ysis on the coefficient of variation of internal quality control in cerebrospinal fluid and application of Westgard sigma rule[J]. Journal of Modern Laboratory Medicine, 2018,33(3): 154-157.
[10] 董辉军, 凡任芝, 周红艳, 等. 安徽省常规生化项目室内不精密度现状分析[J]. 检验医学, 2018, 33(8):752-754. DONG Huijun, FAN Renzhi, ZHOU Hongyan, et al. Internal imprecision status of routine chemical determination items in Anhui laboratories[J].Laboratory Medicine, 2018, 33(8): 752-754.
[11] 费阳, 王薇, 何法霖, 等. 半胱氨酸蛋白酶抑制剂C 室内质控变异系数分析[J]. 临床检验杂志, 2015,33(1): 70-71. FEI Yang, WANG Wei, HE Falin, et al. Analysis of the coefficients of variation for the internal quality control of cystatin C[J]. Chinese Journal of Clinical Laboratory Science, 2015, 33(1): 70-71.
[12] 费阳, 王薇, 何法霖, 等. 尿液定量生化检验项目室内质量控制变异系数调查与分析[J]. 现代检验医学杂志, 2016, 31(6): 154-157. FEI Yang, WANG Wei, HE Falin, et al. Investigation and analysis of the coefficient of variation of internal quality control of quantitative urine chemistry[J].Journal of Modern Laboratory Medicine, 2016, 31(6):154-157.
[13] 宋立兴, 邓焘. 运用Westgard 西格玛规则管理血清淀粉酶室内质量控制[J]. 实用检验医师杂志, 2018,10(4): 205-208. SONG Lixing, DENG Tao. Application of Westgard sigma rule to manage serum amylase indoor quality control[J]. Chinese Journal of Clinical Pathologist,2018, 10(4): 205-208.
[14] 刘翔, 杨洁, 孔丽蕊, 等. 分析批长度Westgard 西格玛规则在临床生化检验项目中的应用[J]. 巴楚医学,2020, 3(1): 61-64. LIU Xiang, YANG Jie, KONG Lirui, et al. Application of Westgard sigma rules of analysis batch length in clinical biochemical tests[J]. Bachu Medical Journal,2020, 3(1): 61-64.
[15] 王麟, 成景松, 胡雪竹. 应用统计质量控制(SQC) 和诺曼图相结合方法对临床血液学常规检验项目风险管理[J]. 现代检验医学杂志, 2019, 34(3): 148-150,155. WANG Lin, CHENG Jingsong, HU Xuezhu. Applying statistical quality control (SQC) and norman diagram to the risk management of clinical hematology routine test items[J]. Journal of Modern Laboratory Medicine,2019, 34(3): 148-150, 155.
[16] NANDA S K, RAY L. Quantitative application of sigma metrics in medical biochemistry[J]. Journal of Clinical and Diagnostic Research, 2013, 7(12): 2689-2691.
[17] 费阳, 王薇, 王治国. 临床检验室内质量控制规则设计新工具-Westgard 西格玛规则[J]. 现代检验医学杂志, 2015, 30(1): 149-152. FEI Yang, WANG Wei, WANG Zhiguo. A new internal quality control rules design tool in clinical laboratory-Westgard sigma rules[J]. Journal of Modern Laboratory Medicine, 2015, 30(1): 149-152.
[18] KASHYAP A, SAMPATH S, TRIPATHI P, et al. Sigma metrics: a valuable Tool for evaluating the performance of internal quality control in laboratory[J]. Journal of Laboratory Physicians, 2021, 13(4): 328-331.
[19] 张楠楠, 李淮淮, 王绪山. 6σ 质量管理在凝血酶原时间室间质量评价与室内质量控制分析应用[J]. 现代检验医学杂志, 2020, 35(3): 149-152. ZHANG Nannan, LI Huaihuai, WANG Xushan. Application of 6σ theory on prothrombin time quality management through the data from external quality assessment and internal quality control[J]. Journal of Modern Laboratory Medicine, 2020, 35(3): 149-152.

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备注/Memo

备注/Memo:
基金项目：贵州省卫健委科技基金项目（gzwjkj2020-1-198）：基于地理信息系统的贵州肺结核时空分析研究。
作者简介：张淑俊（1999-），女，硕士在读，研究方向：室内质量控制， E-mail：1923905931@qq.com。
通讯作者：袁薇（1973-），女，硕士，主任技师，研究方向：病原微生物， E-mail:64692857@qq.com。
更新日期/Last Update: 2024-03-15