1.Analysis of results for the covered rate and acceptable performance of EQA items in nationwide medical laboratories from 2019 to 2023
Zhixin ZHANG ; Zhiguo WANG ; Yuxuan DU ; Bingquan CHEN ; Wei WANG
Chinese Journal of Clinical Laboratory Science 2025;43(2):126-129
Objective To understand the status of medical laboratories participating in external quality assessment(EQA)program in China.Methods The test covered by an EQA control rate and acceptable performance rate of theinformation collection and data analy-sis systems in the EQA program developed by National Center for Clinical Laboratories in medical laboratories of nationwide various re-gions were evaluated descriptively and analyzed statistically.Forty analytes in various disciplines were selected to analyze statistically the implementation of the testing items and participation retes of EQA program.Results The number of medical laboratories participat-ing in EQA program increased yearly from 592 in 2019 to 1 169 in 2023.The nationwide median test covered by an EQA control rate and acceptable performance rate of EQA program reached over 91%and 98%,respectively.In 2023,the median test covered by an EQA control rate of EQA program in the medical laboratories of nationwide regions showed that the median test covered by an EQA con-trol rate reached 100%in Gansu and Hainan regions,and the medians of acceptable performance rate reached 100%in Beijing,Guangdong,Hubei,Jiangsu,Shandong,Shanxi,Shanghai,Tianjin,Xinjiang,and Zhejiang regions.Among the 40 analytes,the test covered by an EQA control rate of only 6 EQA items were greater than 80%in nationwide medical laboratories,i.e.,rheumatoid factor,neonatal deafness gene detection,high throughput sequencing of peripheral fetal chromosome aneuploidy(T21,T18 and T13)by high throughput sequencing,thalassemia gene typing,hepatitis C virus RNA quantification,and EGFR gene mutation,and the acceptable performance rates of only 3 EQA items were 100%,i.e.,HbA2,urine microalbumin,and non-invasive prenatal testing(NIPT).Thir-ty-six analytes exhibited acceptable performance rate above of 80%,while that of troponin I was below 80%.Conclusion The medical laboratories in China should further increase their test covered by an EQA control rate and acceptable performance rate of EQA pro-gram,and consistantly improve testing quality by utilizing EQA programs adequately.
2.Development and Application of the Statistical Quality Control Program Design Software for Clinical Quantitative Measurement Items
Jiali LIU ; Wei WANG ; Bingquan CHEN ; Zhiguo WANG
Journal of Modern Laboratory Medicine 2025;40(5):194-199
Objective To develop a statistical quality control(SQC)program design software to help laboratories design comprehensive SQC programs based on patient risk.Methods Based on the power function diagram,operation process specification diagram,risk-based multi-level internal quality control(IQC)scheme,and online calculator for IQC frequency,corresponding software modules were integrated and designed,and applied the data of potassium project to the software.Results For the power function diagram,operation process specification,and online calculator for IQC frequency,13s/22s/R4s/41s[Number of quality control measurement values(N)=2]was the best choice for potassium for IQC.In the risk-based multi-level IQC scheme,13s/22s/R4s/41s(N=2)could be selected as the startup quality control event,while different subsequent bracketing quality control events could be obtained based on different expected reporting intervals and maximum workloads to achieve the expected quality requirements.Conclusion The development of statistical quality control program design soft is proves beneficial for clinical laboratories to assess the current quality level and select appropriate quality control approaches,and assists the laboratories in enhancing quality.
3.Analysis of results for the covered rate and acceptable performance of EQA items in nationwide medical laboratories from 2019 to 2023
Zhixin ZHANG ; Zhiguo WANG ; Yuxuan DU ; Bingquan CHEN ; Wei WANG
Chinese Journal of Clinical Laboratory Science 2025;43(2):126-129
Objective To understand the status of medical laboratories participating in external quality assessment(EQA)program in China.Methods The test covered by an EQA control rate and acceptable performance rate of theinformation collection and data analy-sis systems in the EQA program developed by National Center for Clinical Laboratories in medical laboratories of nationwide various re-gions were evaluated descriptively and analyzed statistically.Forty analytes in various disciplines were selected to analyze statistically the implementation of the testing items and participation retes of EQA program.Results The number of medical laboratories participat-ing in EQA program increased yearly from 592 in 2019 to 1 169 in 2023.The nationwide median test covered by an EQA control rate and acceptable performance rate of EQA program reached over 91%and 98%,respectively.In 2023,the median test covered by an EQA control rate of EQA program in the medical laboratories of nationwide regions showed that the median test covered by an EQA con-trol rate reached 100%in Gansu and Hainan regions,and the medians of acceptable performance rate reached 100%in Beijing,Guangdong,Hubei,Jiangsu,Shandong,Shanxi,Shanghai,Tianjin,Xinjiang,and Zhejiang regions.Among the 40 analytes,the test covered by an EQA control rate of only 6 EQA items were greater than 80%in nationwide medical laboratories,i.e.,rheumatoid factor,neonatal deafness gene detection,high throughput sequencing of peripheral fetal chromosome aneuploidy(T21,T18 and T13)by high throughput sequencing,thalassemia gene typing,hepatitis C virus RNA quantification,and EGFR gene mutation,and the acceptable performance rates of only 3 EQA items were 100%,i.e.,HbA2,urine microalbumin,and non-invasive prenatal testing(NIPT).Thir-ty-six analytes exhibited acceptable performance rate above of 80%,while that of troponin I was below 80%.Conclusion The medical laboratories in China should further increase their test covered by an EQA control rate and acceptable performance rate of EQA pro-gram,and consistantly improve testing quality by utilizing EQA programs adequately.
4.Development and Application of the Statistical Quality Control Program Design Software for Clinical Quantitative Measurement Items
Jiali LIU ; Wei WANG ; Bingquan CHEN ; Zhiguo WANG
Journal of Modern Laboratory Medicine 2025;40(5):194-199
Objective To develop a statistical quality control(SQC)program design software to help laboratories design comprehensive SQC programs based on patient risk.Methods Based on the power function diagram,operation process specification diagram,risk-based multi-level internal quality control(IQC)scheme,and online calculator for IQC frequency,corresponding software modules were integrated and designed,and applied the data of potassium project to the software.Results For the power function diagram,operation process specification,and online calculator for IQC frequency,13s/22s/R4s/41s[Number of quality control measurement values(N)=2]was the best choice for potassium for IQC.In the risk-based multi-level IQC scheme,13s/22s/R4s/41s(N=2)could be selected as the startup quality control event,while different subsequent bracketing quality control events could be obtained based on different expected reporting intervals and maximum workloads to achieve the expected quality requirements.Conclusion The development of statistical quality control program design soft is proves beneficial for clinical laboratories to assess the current quality level and select appropriate quality control approaches,and assists the laboratories in enhancing quality.
5.Analysis of Clinical Epidemiological Characteristics of 15,967 Lung Cancer Surgery Patients in Yunnan Cancer Hospital from 2013 to 2022.
Ruke TANG ; Yujie LEI ; Lianhua YE ; Guangqiang ZHAO ; Xudong XIANG ; Gaofeng LI ; Guangjian LI ; Xi WANG ; Ying CHEN ; Kaiyun YANG ; Xiaobo CHEN ; Jiapeng YANG ; Min ZHAO ; Bingquan XIANG ; Qiubo HUANG ; Guangcan LUO ; Hongwei ZHANG ; Yunchao HUANG
Chinese Journal of Lung Cancer 2024;27(12):911-918
BACKGROUND:
Lung cancer is a disease with a high incidence rate in Yunnan province, yet there is a paucity of large-scale studies on its clinical epidemiology. This research aims to investigate the epidemiological characteristics of patients who underwent lung cancer surgery at Yunnan Cancer Hospital over the past decade, thereby providing a theoretical basis for the prevention and treatment of lung cancer.
METHODS:
Clinical data were collected from 15,967 patients who underwent lung cancer surgery at Yunnan Cancer Hospital between 2013 and 2022. A statistical analysis was conducted on the patients' general data, surgical information, pathological types of lung cancer, and other clinical epidemiological characteristics.
RESULTS:
Among the 15,967 cases of lung cancer, 46.3% were male and 53.7% were female, with the male-to-female ratio ranging from 0.68 to 1.61:1. The median age was 56 years (interquartile range: 49-63), and 37.0% of the patients were in the age group of 50-59 years. Since 2017, there has been an annual increase in the proportion of patients under the age of 60 years. The smoking status of the patients showed that 28.1% were smokers and 71.9% were non-smokers. Qujing city accounted for 41.4% and Kunming city for 23.2% of the cases in Yunnan province, with 29.6% of patients originating from Xuanwei and Fuyuan areas of Qujing city. The distribution of affected lung lobes was as follows: right upper lobe 28.2%, right middle lobe 6.3%, right lower lobe 20.1%, left upper lobe 22.7%, and left lower lobe 16.4%. The use of thoracoscopic surgery increased from 30.8% to 96.3%, with single-port thoracoscopic surgery comprising 61.3%. Lobectomy was performed in 64.2% of cases, wedge resection in 17.2%, and segmentectomy in 12.2%. The proportion of lobectomy decreased from 83.1% to 46.1%. The proportion of patients in stages 0-I increased from 43.5% to 82.8%, while stages II-IV decreased from 56.5% to 17.2%. Adenocarcinoma increased from 75.6% to 88.3%, and squamous cell carcinoma decreased from 21.5% to 8.6%. Among adenocarcinoma patients, 60.9% were female. Among sguamous cell carcinoma patients, 90.6% were male. The peak age for adenocarcinoma was 50-59 years, and for squamous cell carcinoma, it was 60-69 years. The smoking rate was higher among squamous cell carcinoma patients (65.9%) compared to adenocarcinoma patients (22.3%). Adenocarcinoma patients had a higher proportion in stages 0-I (76.3%), while squamous cell carcinoma patients were more prevalent in stages II-III (64.1%).
CONCLUSIONS
The findings indicate an increasing proportion of female patients with adenocarcinoma, a younger age of onset, a higher proportion of non-smoking lung cancer patients, and an increased proportion of stages 0-I lung cancer. These trends may reflect the epidemiological characteristics of patients undergoing lung cancer surgery in Yunnan and surrounding areas over the past decade.
Humans
;
Female
;
Male
;
Lung Neoplasms/pathology*
;
Middle Aged
;
China/epidemiology*
;
Aged
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Adult
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Aged, 80 and over
6.Analysis of external quality assessment results for quality indicators of interlaboratory comparison rate from 2016 to 2023
Zhixin ZHANG ; Zhiguo WANG ; Yuxuan DU ; Jiali LIU ; Bingquan CHEN ; Wei WANG
Chinese Journal of Clinical Laboratory Science 2024;42(12):927-930
Objective To understand the situation of interlaboratory comparison for without external quality assessment(EQA)test by analyzing the results of quality indicators related to interlaboratory comparison rate of EQA from 2016 to 2023,in order to provide some suggestions for comparison.Methods The National Center for Clinical Laboratories organized 31 centers of provinces(autonomous re-gions and municipalities directly)to launch a synchronous Quality Indicators(QIs)-EQA program.The data were reported via devel-oped online EQA system.The essential information of the clinical laboratories and the data of quality indicators of interlaboratory com-parison rate were collected.The median(lower quartile,upper quartile)M(Q1,Q3)of the interlaboratory comparison rate was calcu-lated,and the quality level of the laboratory was evaluated by sigma measurement,and the statistics of the classification(tertiary and secondary hospitals)were carried out to understand the differences in the interlaboratory comparison rate among different hospital grades.Mann-Whitney U test was used to compare the two groups(different years or different hospital grades),and P<0.05(α=0.05)indicated that the difference was statistically significant.Results The number of return laboratories increased from 6 701 in 2016 to 11 579 in 2023.The national median results showed that the interlaboratory comparison rate had been increasing year by year(excluding 2021),from 1.6%in 2016 to 3.8%in 2023.The median grading results showed that the interlaboratory comparison rate of tertiary hospitals was higher than that of secondary hospitals.In 2023,the interlaboratory comparison rate was 10.3%for tertiary hospi-tals and 2.3%for secondary hospitals.The results of all the years were below 3σ level.The median interlaboratory comparison rate of tertiary hospitals in various regions showed that Shanghai,Ningxia,and Sichuan exhibited higher median.The median interlaboratory comparison rate of secondary hospitals showed that Shanghai,Sichuan,and Hainan exhibited higher median.Conclusion At present period,the interlaboratory comparison rate has still been low in those laboratories without EQA tests.Therefore,the medical laborato-ries without EQA tests should strengthen interlaboratory comparisons to verify the reliability of their results.
7.Epidemiological investigation of iron deficiency among preschool children in 10 provinces, autonomous regions, or municipalities in China
Lei WANG ; Jie SHAO ; Wenhong DONG ; Shuangshuang ZHENG ; Bingquan ZHU ; Qiang SHU ; Wei CHEN ; Lichun FAN ; Jin SUN ; Yue GAO ; Youfang HU ; Nianrong WANG ; Zhaohui WANG ; Tingting NIU ; Yan LUO ; Ju GAO ; Meiling TONG ; Yan HU ; Wei XIANG ; Zhengyan ZHAO ; Meng MAO ; Fan JIANG
Chinese Journal of Pediatrics 2024;62(5):416-422
Objective:To understand the current status of anemia, iron deficiency, and iron-deficiency anemia among preschool children in China.Methods:A cross-sectional study was conducted with a multi-stage stratified sampling method to select 150 streets or townships from 10 Chinese provinces, autonomous regions, or municipalities (East: Jiangsu, Zhejiang, Shandong, and Hainan; Central: Henan; West: Chongqing, Shaanxi, Guizhou, and Xinjiang; Northeast: Liaoning). From May 2022 to April 2023, a total of 21 470 children, including community-based children aged 0.5 to<3.0 years receiving child health care and kindergarten-based children aged 3.0 to<7.0 years, were surveyed. They were divided into 3 age groups: infants (0.5 to<1.0 year), toddlers (1.0 to<3.0 years), and preschoolers (3.0 to<7.0 years). Basic information such as sex and date of birth of the children was collected, and peripheral blood samples were obtained for routine blood tests and serum ferritin measurement. The prevalence rates of anemia, iron deficiency, and iron-deficiency anemia were analyzed, and the prevalence rate differences were compared among different ages, sex, urban and rural areas, and regions using the chi-square test.Results:A total of 21 460 valid responses were collected, including 10 780 boys (50.2%). The number of infants, toddlers, and preschoolers were 2 645 (12.3%), 6 244 (29.1%), and 12 571 (58.6%), respectively. The hemoglobin level was (126.7±14.8) g/L, and the serum ferritin level was 32.3 (18.5, 50.1) μg/L. The overall rates of anemia, iron deficiency, and iron-deficiency anemia were 10.4% (2 230/21 460), 28.3% (6 070/21 460), and 3.9% (845/21 460), respectively. The prevalence rate of anemia was higher for boys than for girls (10.9% (1 173/10 780) vs. 9.9% (1 057/10 680), χ2=5.58, P=0.018), with statistically significant differences in the rates for infants, toddlers and preschoolers (18.0% (475/2 645), 10.6% (662/6 244), and 8.7% (1 093/12 571), respectively, χ2=201.81, P<0.01), and the rate was significantly higher for children in rural than that in urban area (11.8% (1 516/12 883) vs. 8.3% (714/8 577), χ2=65.54, P<0.01), with statistically significant differences in the rates by region ( χ2=126.60, P<0.01), with the highest rate of 15.8% (343/2 173) for children in Central region, and the lowest rate of 5.3% (108/2 053) in Northeastern region. The prevalence rates of iron deficiency were 33.8% (895/2 645), 32.2% (2 011/6 244), and 25.2% (3 164/12 571) in infants, toddlers, and preschoolers, respectively, and 30.0% (3 229/10 780) in boys vs. 26.6% (2 841/10 680) in girls, 21.7% (1 913/8 821), 40.0% (870/2 173), 27.1% (2 283/8 413), 48.9% (1 004/2 053) in Eastern, Central, Western, and Northeastern regions, respectively, and each between-group showed a significant statistical difference ( χ2=147.71, 29.73, 773.02, all P<0.01). The prevalence rate of iron-deficiency anemia showed a significant statistical difference between urban and rural areas, 2.9% (251/8 577) vs. 4.6% (594/12 883) ( χ2=38.62, P<0.01), while the difference in iron deficiency prevalence was not significant ( χ2=0.51, P=0.476). Conclusions:There has been a notable improvement in iron deficiency and iron-deficiency anemia among preschool children in China, but the situation remains concerning. Particular attention should be paid to the prevention and control of iron deficiency and iron-deficiency anemia, especially among infants and children in the Central, Western, and Northeastern regions of China.
8.Evaluate the Performance of Statistical Quality Control Procedures in Westgard Sigma Rules Based on Power Function Graphs in Clinical Laboratories
Jiali LIU ; Wei WANG ; Bingquan CHEN ; Zhiguo WANG
Journal of Modern Laboratory Medicine 2024;39(1):175-178,191
Objective The performance characteristics of statistical quality control procedures in Westgard sigma rule are analyzed by using the power function graph.Methods According to the drawing principle of power function graph,the internal quality control program design software of clinical laboratory quantitative measurement was developed.and the Westgard sigma rule quality control procedures were simulated with power function graph.The performance of the quality control procedures recommended by Westgard sigma was analyzed by combining different sigma quality levels.Results The rules recommended by Westgard sigma were relatively simple rules that can meet the requirements of error detection probability and false rejection probability.Conclusion The internal quality control procedure design software for quantitative clinical testing has verified the performance of Westgard sigma recommendation rules.The Westgard sigma rule diagram is intuitive and convenient,the laboratory can use the Westgard sigma recommendation rules for internal quality control.
9.Factors associated with nursery care institution attendance for children aged 0 - 3 years old and the basic characteristics of nursery care institutions that children were enrolled in
Wenhong DONG ; Xinmeng YAO ; Xin XU ; Lina LYU ; Shasha WANG ; Shuangshuang ZHENG ; Lei WANG ; Bingquan ZHU ; Jie SHAO
Chinese Journal of Child Health Care 2024;32(2):122-126
【Objective】 To understand factors associated with children′s attendance at nursery care institutions (NCIs) and the basic characteristics of the NCIs children were enrolled in, so as to provide scientific evidence for policymakers. 【Methods】 During November 2020 and January 2021, parents who visited the Department of Child Health Care in six selected maternal and children′s hospitals, as well as nearby NCIs in Zhejiang were invited to finish an online questionnaire. Information such as children′s sociodemographic characteristics, parents′ knowledge, attitude and practice regarding nursery and feeding, etc. were collected. A total of 1 756 questionnaires were collected. 【Results】 Compared to children who were not in NCIs, children enrolled in NCIs were older (94.4% of children ≥24 months vs. 30.1%, χ2=835.27), more likely to be from the local area (87.2% vs. 81.4%,χ2=12.25), more likely to have parents with a college degree (mother: 83.6% vs. 74.2%, χ2=35.29; father: 79.9% vs. 70.0%, χ2=27.01), had a higher prevalence of family annual income >200 000 CNY (49.5% vs. 28.2%, χ2=110.49), and were less likely to have their grandparents available to take care of them (16.7% vs. 26.8%, χ2=31.4) The difference all have great significant.(P<0.05). In a multivariate Logistic regression model, the older the child, the more likely they were to attend an NCI (for children aged 6 - 23 months, OR=6.70; for children aged 24 - 35 months, OR=134.03; and for children aged 36 - 42 months, OR=699.33; P<0.05). Family annual income was positively associated with children′s attendance at NCIs (for those earning 100 000 - 200 000 CNY/year, OR=1.63; for those earning 200 000 - 500 000 CNY/year, OR=2.96; and for those earning >500 000 CNY/year, OR=4.62, P<0.05). Conversely, the higher the level of grandparent involvement in daily care, the lower the attendance at NCIs (for children cared for by both parents and grandparents, OR=0.57; for those primarily cared for by grandparents, OR=0.26, P<0.05). For children who used to stay at NCIs, 82.8% stayed at institutions that only recruited children aged 0 - 3 years, 97.4% spent their whole day in NCIs, and 71.4% spent less than 3 000 CNY per month for NCI services. Additionally, over 95% of parents were satisfied with the food and care services in NCIs, as well as their children′s physical development in NCIs. However, 32.1% of NCIs were reported by parents as having no room for breastfeeding. 【Conclusions】 Children′s age, grandparent involvement in routine care, and family annual income are the main factors associated with children′s attendance at NCIs. There is a greater need for more affordable and community-based NCIs, particularly for children under 2 years old. Additionally, more attention should be paid to the quality surveillance, assessment and management of NCIs.
10.Analysis of external quality assessment results for quality indicators of interlaboratory comparison rate from 2016 to 2023
Zhixin ZHANG ; Zhiguo WANG ; Yuxuan DU ; Jiali LIU ; Bingquan CHEN ; Wei WANG
Chinese Journal of Clinical Laboratory Science 2024;42(12):927-930
Objective To understand the situation of interlaboratory comparison for without external quality assessment(EQA)test by analyzing the results of quality indicators related to interlaboratory comparison rate of EQA from 2016 to 2023,in order to provide some suggestions for comparison.Methods The National Center for Clinical Laboratories organized 31 centers of provinces(autonomous re-gions and municipalities directly)to launch a synchronous Quality Indicators(QIs)-EQA program.The data were reported via devel-oped online EQA system.The essential information of the clinical laboratories and the data of quality indicators of interlaboratory com-parison rate were collected.The median(lower quartile,upper quartile)M(Q1,Q3)of the interlaboratory comparison rate was calcu-lated,and the quality level of the laboratory was evaluated by sigma measurement,and the statistics of the classification(tertiary and secondary hospitals)were carried out to understand the differences in the interlaboratory comparison rate among different hospital grades.Mann-Whitney U test was used to compare the two groups(different years or different hospital grades),and P<0.05(α=0.05)indicated that the difference was statistically significant.Results The number of return laboratories increased from 6 701 in 2016 to 11 579 in 2023.The national median results showed that the interlaboratory comparison rate had been increasing year by year(excluding 2021),from 1.6%in 2016 to 3.8%in 2023.The median grading results showed that the interlaboratory comparison rate of tertiary hospitals was higher than that of secondary hospitals.In 2023,the interlaboratory comparison rate was 10.3%for tertiary hospi-tals and 2.3%for secondary hospitals.The results of all the years were below 3σ level.The median interlaboratory comparison rate of tertiary hospitals in various regions showed that Shanghai,Ningxia,and Sichuan exhibited higher median.The median interlaboratory comparison rate of secondary hospitals showed that Shanghai,Sichuan,and Hainan exhibited higher median.Conclusion At present period,the interlaboratory comparison rate has still been low in those laboratories without EQA tests.Therefore,the medical laborato-ries without EQA tests should strengthen interlaboratory comparisons to verify the reliability of their results.

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