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.

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.

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.

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.

Purpose To investigate the CT and MRI features of papillary tumor of the pineal region(PTPR).Materials and Methods A total of seven cases pathologically diagnosed as PTPR in Nanfang Hospital,Southern Medical University from August 2009 to December 2022 were retrospectively analyzed,including patients'clinical and imaging data.Seven patients underwent MRI plain and enhanced scan,and five patients underwent CT scan at the same time.Results Supratentorial hydrocephalus was found in seven cases.The boundary of the tumor was clear,with a maximum diameter of about 1.8-5.9 cm,with an average of(2.8±1.5)cm.The tumors appeared as round in four cases and irregular masses in three cases.MRI showed mixed intensity on T1WI and inhomogeneous slight hyperintensity on T2WI of most cases,in which four lesions showed small patchy hyperintensity on T1WI.Four cases underwent diffusion weighted imaging,and three cases showed limited diffusion.Six PTPR lesions showed cystic degeneration,and three lesions had hemorrhage.On contrast-enhanced scans,most of the tumors demonstrated inhomogeneous moderate to obvious enhancement.The solid components of the lesions showed slightly high density on CT both in five cases,and calcification was present in three cases.Conclusion The imaging findings of PTPR have some characteristics,mostly with well-defined round or irregular masses,the tumor is prone to cystic degeneration,and the hyperintensity on T1WI is one of the characteristic images of the disease.

Purpose To investigate the CT and MRI features of papillary tumor of the pineal region(PTPR).Materials and Methods A total of seven cases pathologically diagnosed as PTPR in Nanfang Hospital,Southern Medical University from August 2009 to December 2022 were retrospectively analyzed,including patients'clinical and imaging data.Seven patients underwent MRI plain and enhanced scan,and five patients underwent CT scan at the same time.Results Supratentorial hydrocephalus was found in seven cases.The boundary of the tumor was clear,with a maximum diameter of about 1.8-5.9 cm,with an average of(2.8±1.5)cm.The tumors appeared as round in four cases and irregular masses in three cases.MRI showed mixed intensity on T1WI and inhomogeneous slight hyperintensity on T2WI of most cases,in which four lesions showed small patchy hyperintensity on T1WI.Four cases underwent diffusion weighted imaging,and three cases showed limited diffusion.Six PTPR lesions showed cystic degeneration,and three lesions had hemorrhage.On contrast-enhanced scans,most of the tumors demonstrated inhomogeneous moderate to obvious enhancement.The solid components of the lesions showed slightly high density on CT both in five cases,and calcification was present in three cases.Conclusion The imaging findings of PTPR have some characteristics,mostly with well-defined round or irregular masses,the tumor is prone to cystic degeneration,and the hyperintensity on T1WI is one of the characteristic images of the disease.

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.

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.

Objective To investigate the clinical value of thromboelastography (TEG) in monitoring the coagulation function change after plasma supplementation in the patients with severe liver cirrhosis diges-tive tract hemorrhage.Methods A total of 48 patients with high risk and extreme high risk liver cirrhosis a-cute upper digestive hemorrhage receiving the treatment in ICU of this hospital from February 2020 to March 2023 were selected as the study subjects.After plasma infusion with the dose of 10 mL/kg,the coagulation function status was detected.The patients were divided into the TEG group (n=20) and the control group (n=28) according to different detection modes of coagulation function.The TEG group simultaneously detec-ted TEG and traditional coagulation function detection,while the control group only conducted the traditional coagulation detection.TEG and coagulation function detection indicators after the infusion of plasma were compared between the two groups.The plasma infusion amounts at 24 h after admitting in ICU were recorded and the control status of digestive tract hemorrhage was evaluated.Results The R value in the TEG group was (8.02±6.09)min,the K vale was 2.5(1.3,5.0)min,the coagulation comprehensive index (CI) was-4.70±6.29,the maximal shear stress coefficient (MA) was 50.35±18.84,LY30 was 0.The Pearson corre-lation analysis showed that MA was positively correlated with FIB and PLT (r=0.470,0.526,P<0.05),and the other indexes had no correlation.Compared with the control group,the plasma infusion amounts in the TEG group was more[(419.00±143.18)mL vs. (400.00±137.54)mL],the digestive tract hemorrhage con-trol rate was higher[75.00％(15/20) vs. 53.57％(15/28)],but the differences were not statistically signifi-cant (P>0.05).The multiple linear regression was MA=-3.427+11.200×Ln(PLT)+10.230×Ln(FIB).Con-clusion In the patients with severe lever cirrhosis acute upper gastrointestinal bleeding,TEG could earlier find the co-agulation function improvement situation after plasma supplementation than the traditional coagulation detection.

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.