1.Investigation on the basic situation of pre-analytical quality management in blood station laboratories in North China
Jing SUN ; Hongwei GE ; Zhengmin LIU ; Qianqian QIN ; Wei HAN ; Tong PAN ; Dongli JIAO ; Xiaolan DONG ; Rui WANG
Chinese Journal of Blood Transfusion 2025;38(11):1514-1520
Objective: To investigate the basic situation of pre-analytical quality management in blood station laboratories in North China, and to provide baseline data for promoting the homogenization and standardization of these pre-analytical processes in each blood station laboratory. Methods: A cross-sectional status survey was designed based on the quality management regulations of blood stations, ISO15189 standards and relevant quality management requirements. This survey covering various aspects including laboratory general situation, sample collection and temporary storage, transportation, reception, and quality continuous improvement situations. Data analysis was performed on the survey results of each laboratory. Results: All the 38 blood station laboratories in North China had established a pre-analytical quality management system framework and implemented basic pre-analytical quality control activities; however, there were differences in implementation. 1) Among the 12 basic quality items, 3 items were monitored by all the investigated laboratories (100%), 6 items were monitored by the vast majority of laboratories (about 90%), and 3 items were monitored by a portion of laboratories (about 60%). There were no significant differences in the monitoring index among the three regions and among different types of laboratories (P>0.05). 2) Among the total of 26 items in the three key processes before testing (sample collection and storage, transportation, reception and processing), 12 items were monitored by all laboratories (100%), 11 items were monitored by the vast majority of laboratories (about 90%), and 3 items were monitored by a portion of laboratories (about 75%). There were no significant differences in monitoring index among different regions and types of laboratories (P>0.05). Conclusion: This survey provides a reference and basis for the gap analysis of the pre-analytical process quality management in 38 blood station laboratories across North China. It facilitates laboratories in identifying pre-analytical quality problems, resolving problems, preventing errors, and ensuring that the quality of blood samples before testing meets the established requirements. It lays a foundation for the homogenization of pre-analytical quality management in regional blood stations.
2.Analysis of unqualified pre-analytical samples in blood station laboratories in North China
Zhengmin LIU ; Hongwei GE ; Qianqian QIN ; Wei HAN ; Tong PAN ; Dongli JIAO ; Xiaolan DONG ; Rui WANG
Chinese Journal of Blood Transfusion 2025;38(11):1521-1528
Objective: To determine the frequency and main reasons of unqualified samples by analyzing the quality of pre-analytical samples in blood stations in North China, thereby providing a reference and basis for gap analysis in the implementation of pre-analytical process quality management for participating laboratories and ensuring that only high-standard and high-quality blood samples proceed to testing. Methods: Data on the quality of pre-analytical samples from blood station laboratories in North China was collected via questionnaire. Statistical analysis were performed on: 1) the basic information of samples quality monitoring in the laboratories; 2) the distribution of the overall pre-analytical unqualified rate of samples and the pre-analytical unqualified rate of samples in each laboratory; 3) the distribution of reasons for sample disqualification. Results: 1) The overall pre-analytical unqualified rate of samples in blood station laboratories in North China was 4.55, with a total sigma level of 5.39σ. The 25th, 50th and 75th percentiles (P25, P50, P75) for the total unqualified rate were 0.00, 1.10 and 5.96, respectively. The corresponding percentiles for the Sigma level were 5.34σ, 5.71σ, and 6.00σ, respectively. The pre-analytical unqualified rate of serological and nucleic acid samples (4.89 vs 4.22) showed a significant difference (χ
=9.575, P<0.05). 2) The average unqualified rate of samples in region A, B and C was 1.71, 9.50 and 12.64 (χ
=1 590.721, P<0.05), and the sigma level was 5.66σ, 5.21σ and 5.16σ, respectively. 3) The main reasons for unqualified serological samples were chylous blood (72.65%), hemolysis (17.39%), abnormal hematocrit (5.80%), and insufficient volume (3.50%). The main reasons for the unqualified nucleic acid samples were chylous blood (78.26%), hemolysis (8.84%), failure to centrifuge as required (5.01%), abnormal hematocrit (4.66%), and insufficient volume (1.92%). Conclusion: In North China, the quality indicators for the pre-analytical processes in blood station laboratories are generally well-managed. Laboratories in region A outperformed the national average in pre-analytical specimen quality control. However, participating laboratories exhibit gaps in implementing pre-analytical quality management. Through effective analysis of pre-analytical process quality metrics and inter-laboratory comparisons, laboratories can identify discrepancies and address shortcomings. By establishing clear quality objectives, they can achieve continuous improvement and ensure the validity of test results.
3.Investigation on the management of hemolytic and lipemic samples in the preanalytical phase in blood station laboratories in North China
Jing SUN ; Hongwei GE ; Zhengmin LIU ; Qianqian QIN ; Wei HAN ; Tong PAN ; Dongli JIAO ; Xiaolan DONG ; Rui WANG
Chinese Journal of Blood Transfusion 2025;38(11):1529-1534
Objective: To investigate the assessment criteria and subsequent handling practices of hemolytic and lipemic blood samples before testing in blood screening laboratories in North China, and to provide data to support the standardization of their management in blood station laboratories. Methods: Data on the preanalytical management of hemolytic and lipemic samples from 38 laboratories were collected. The details of management on the criteria and verificatioon for assessment, the assessment methods, and subsequent handling procedures of hemolytic and lipemic samples in blood station laboratories were analyzed. Results: 1) All 38 blood station laboratories monitored serological and nucleic acid samples for hemolysis and lipemia in pre-analytical phase. 2) The criteria and methods for assessing hemolytic and lipemic samples varied among the laboratories of the 38 blood stations. 15 laboratories (39.47%) followed manufacturer's instructions, 9 laboratories (23.68%) formulated their own criteria, and 14 laboratories (36.84%) referred to the criteria of other laboratories. 16 laboratories (42.11%) verified the criteria for assessing hemolytic and lipemic samples, with significant variations in verification rate across laboratories from different regions (P<0.05). For the assessment methods, visual inspection was used by 28 laboratories (73.68%) for hemolytic samples and by 27 laboratories (71.05%) for lipemic samples; the colorimetric card method was used by 10 laboratories (26.32%) for assessing both hemolytic and lipemic samples; the instrumental method was used by 1 laboratory (2.63%) for assessing lipemic samples.3) The handling procedures for hemolytic and lipemic samples varied significantly and followed a gradient distribution pattern among 38 laboratories (including accepting samples for testing, accepting samples for concession testing, re-collecting samples, and rejecting samples and halting testing). With increasing severity of hemolysis and lipemia, more laboratories halted testing, and relatively fewer laboratories accepted samples for normal testing. 5 laboratories (13.16%) applied different handling procedures on serological and nucleic acid samples. Conclusion: This survey provides a reference and basis for analyzing gaps in the management of hemolytic and lipemic samples during the preanalyical phase in blood station laboratories in North China. It enables laboratories to identify the problems and deficiencies in the management of hemolytic and lipemic samples, to ensure preanalytical samples quality meets the established requirements, and to lay a foundation for promoting the homogenization and standardization of the regional sample quality management mode.
4.Construction and validation of a risk prediction model for acute myocardial infarction complicated by malignant ventricular arrhythmias
Dongli SONG ; Shengnan LIU ; Shuo WU ; Jie GAO ; Xiao ZHANG ; Weikai CUI ; Yifan WANG ; Jiali WANG ; Yuguo CHEN
Chinese Journal of Emergency Medicine 2025;34(7):923-931
Objective:To analyze the risk factors for in-hospital malignant ventricular arrhythmia (MVA) in acute myocardial infarction (AMI) and to construct and validate a risk prediction model.Methods:This study was a retrospective cohort study. Patients aged≥18 years who were admitted to Qilu Hospital of Shandong University with a diagnosis of AMI and underwent coronary angiography (CAG) from May 2016 to March 2023 were selected, and the patients' clinical routine test indicators and CAG results were collected. Univariate and bidirectional stepwise logistic regression were used to screen out the risk factors for constructing the best prediction model. The prediction model was constructed by combining the results of multivariate logistic regression. The Hosmer-Lemeshow test and ROC curve, calibration curve, and decision curve were drawn to evaluate the model. The nomogram was drawn to visualize the model, and the Bootstrap self-sampling method was used for internal validation. The ROC curve was drawn to evaluate the predictive performance of each risk factor and prediction model. Finally, a multicollinearity test was performed.Results:Among the 4 205 patients finally included in the study, 115 patients (2.735%) developed MVA during hospitalization. The predictive factors screened out included age (X1), diastolic blood pressure (X2), respiratory rate (X3), blood glucose (X4), serum potassium (X5), logarithmic NT-proBNP (X6), myocardial infarction type (NSTEMI=X7, unclassified=X8), J wave (X9), Killip grade (Ⅱ=X10, Ⅲ=X11, Ⅳ=X12), and the regression equation was ln(p/1-p)=-4.699+0.029×X1-0.012×X2+0.059×X3+0.148×X4-1.175×X5+0.866×X6-1.427×X7-0.475×X8+0.758×X9+0.294×X10+0.902×X11+1.815×X12. The area under the ROC curve (AUC) of the model was 0.855 (95% CI: 0.816-0.894), and the Hosmer-Lemeshow test ( χ2=14.178, P=0.077) and the calibration curve showed that the predicted probability was consistent with the actual probability. The probability threshold of 0% to 65% had a better clinical net benefit. The area under the internal validation ROC curve (AUC) was 0.855, 95% CI: 0.813-0.891. The prediction performance of the nine variables was stronger than that of any single variable. There was no multicollinearity between the variables. Conclusions:Age, diastolic blood pressure, respiratory rate, blood glucose, serum potassium, NT-proBNP, type of AMI, J wave, and Killip class are forecasting indicator for in-hospital MVA in AMI. The risk prediction model based on the above factors has good predictive performance.
5.Clinical application of XperCT combined with needle-guided Glubran-2 glue for small pulmonary nodule localization in thoracoscopic pulmonary nodule resection
Jie ZHANG ; Jingqin CAO ; Xian LIU ; Longxiang LAI ; Qian WANG ; Yingchun ZHANG ; Dongli FAN ; Defen ZHANG
Journal of Interventional Radiology 2024;33(6):623-626
Objective To discuss the application value of XperCT combined with needle-guided Glubran-2 glue for small pulmonary nodule localization in thoracoscopic pulmonary nodule resection.Methods The clinical data of 67 patients,who received XperCT combined with needle-guided Glubran-2 glue for small pulmonary nodule localization before thoracoscopic resection of a single small pulmonary nodule at the Jining Municipal First People's Hospital of China between June 2018 and February 2023,were retrospectively analyzed.The size of the pulmonary nodule,the maximum vertical distance from the visceral pleura to the lesion,the technical success rate of localization,the number of puncturing times,the complications,the time spent for operation,and the postoperative pathological diagnosis were recorded.Results The average size of the small pulmonary nodules in the 67 patients was 8.7 mm,and the average vertical distance from the visceral pleura to the lesion was 19.4 mm.Successful preoperative localization of nodule was accomplished in all patients.The average number of puncturing times was 1.1,and no serious complications occurred.The average time spent for operation was 12.7 min.Definite pathological results were obtained in all 67 patients.Conclusion XperCT combined with needle-guided Glubran-2 glue for small pulmonary nodule localization carries advantage of accurate localization with fewer complications.Therefore,this technique is a highly-efficient and quickly-accomplished positioning method,and it is highly valuable in clinical practice.(J Intervent Radiol,2024,33:623-626)
6.Methodology dilemma of Western bioethics and transcendent approach based on Confucian bioethics
Xufeng LU ; Dongli LIU ; Hongyao ZHAO ; Shan ZHANG
Chinese Medical Ethics 2024;37(12):1453-1458
Western bioethics,with its theoretical basis in individualism,is essentially a form of universalist ethics that makes it difficult to respond to the complexities of moral life.Scholars represented by Engelhardt and MacIntyre have profoundly reflected on universalist ethics from the perspective of moral pluralism,but they have not been able to fundamentally resolve the disputes.Grasping the theoretical lineage of the controversy between universalism and particularism can provide an important reference for the construction of bioethics based on Confucianism in contemporary China.Furthermore,from the perspective of opposing universalism and particularism,as well as in response to the issues of the era of life science and technology and the cultural background of China,it can not only realize the modern interpretation of Confucian ethics,but also promote the effective application of modern bioethics theory.
7.Retrospective analysis of 2 657 serum autoantibodies results detected by multiple methods
Dongli CHE ; Tingxuan CHENG ; Jinlong DU ; Qing LIU ; Ye TIAN ; Lina SHI ; Xiaoning WANG ; Fei XIE ; Yuan GU ; Yanguo TAN
International Journal of Laboratory Medicine 2024;45(23):2838-2843
Objective To investigate the performance of different methods in common autoantibody detec-tion,and to provide basis for the detection strategy of autoantibody.Methods A total of 2 657 cases were in-cluded in this study,whose serum antinuclear antibody(ANA)by indirect immunofluorescence method(IIF)and antinuclear antibody spectrum(ANAs,a total of 15 antibodies)by immunoblot method(IB)were tested simultaneously,and anti-double strand DNA antibody(anti-dsDNA antibody)were tested by IIF,enzyme linked immunosorbent assay(ELISA)and IB.ANCA and ANCA spectrum[anti-myeloperoxidase antibody(anti-MPO antibody),anti-protease 3 antibody(anti-PR3 antibody)]were tested by IIF and ELISA respec-tively in 2 348 cases.Results Firstly,the detection rate of ANA was significantly higher than that of ANAs(57.77%vs.30.64%,P<0.001).Among the specimens detected with ANA,40.78%detected at least one specific antibody positive.Among the specimens detected with ANAs positive,ANA was not detected in 23.10%of cases.Secondly,the ANA positive cases were mainly of lower titers,and cases with titer of ≤1∶320 accounted for 84.95%of the total detected cases.But the higher the titer,the higher the detection rate of ANAs specific antibodies(29.63%in 1∶100,48.56%in 1∶320,77.78%in 1∶1 000,92.42%in≥1∶3 200).Thirdly,among the specimens detected ANAs positive,the composition ratios of anti-Scl-70,anti-PM-Scl and anti-PCNA antibodies in ANA positive cases was significantly lower than those in ANA negative cases(P<0.001).Fourthly,the detection rate of anti-dsDNA antibody by ELISA was the highest(4.14%),which was significantly higher than those by IIF or IB(both P<0.001),and the difference in detection efficacy of the latter two methods was also statistically significant(P<0.001).Even so,the IIF and IB for the detection of anti-dsDNA antibody still had a certain complementary effect on ELISA.Fifthly,the positive rate of ANCA by IIF was significantly higher than that of ANCA spectrum(9.16%vs.2.43%),but among those who were detected anti-MPO antibodies and/or anti-PR3 antibodies positive,47.37%were ANCA negative.Conclusion Different methods for detecting autoantibodies have significantly different detection efficacy,and it is partic-ularly necessary to adopt correct detection strategies based on evidence-based medicine.
8.Transcatheter arterial embolization with Glubran-2 glue for treating hemorrhage after percutaneous transhepatic cholangial drainage
Jie ZHANG ; Jingqin CAO ; Xian LIU ; Longxiang LAI ; Qian WANG ; Yingchun ZHANG ; Dongli FAN ; Defen ZHANG
Chinese Journal of Interventional Imaging and Therapy 2023;20(12):722-725
Objective To observe the effect of transcatheter arterial embolization(TAE)with Glubran-2 glue for treating hemorrhage after percutaneous transhepatic cholangial drainage(PTCD).Methods Data of 17 patients with hemorrhage after PTCD who underwent TAE with Glubran-2 glue were retrospectively analyzed.The technical success rate,clinical success rate and complications were observed.The red blood cell(RBC)and hemoglobin(Hb)on the day of TAE and the next day of TAE were compared,also the glutamic-pyruvic transaminase(GPT)level before TAE,on the next day of TAE,on the second and the fourth day after TAE,respectively.Results The offending vessel of bleeding was successfully embolized in all 17 cases,both technical success rate of TAE and clinical success rate of hemostasis were 100%.There was no serious complication such as liver abscess,septicemia nor pulmonary embolism.No significant difference of RBC nor Hb was found between the day of TAE and the next day of TAE(both P>0.05).GPT before TAE was lower than the next day of TAE and the second day after TAE(P<0.05),while no significant difference of GPT was found before TAE and 4 days after TAE(P>0.05).Conclusion TAE with Glubran-2 glue for treating hemorrhage after PTCD was safe and effective.
9.Retrospective study on the types and characteristics of shock in polytrauma patients at different stages after trauma
Jialiu LUO ; Liangsheng TANG ; Deng CHEN ; Hai DENG ; Jingzhi YANG ; Teding CHANG ; Jing CHENG ; Huaqiang XU ; Miaobo HE ; Dongli WAN ; Feiyu ZHANG ; Mengfan WU ; Qingyun LIU ; Shibo WEI ; Wenguo WANG ; Gang YIN ; Zhaohui TANG
Chinese Journal of Emergency Medicine 2023;32(1):70-75
Objective:To investigate the types, incidences, and clinical characteristics of shock in polytrauma patients at different stages after polytrauma.Methods:A retrospective study was conducted on polytrauma patients admitted to multiple trauma centers from June 2020 to December 2021. The inclusion criteria were patients >18 years old and treated due to polytrauma. Exclusion criteria included an admission time of more than 48 h after trauma, a history of malignancy, or metabolic, consumptive, and immunological diseases. The early stage was defined as the period of ≤48 h after polytrauma, and the middle stage was defined as the period between 48 h and 14 days. The patient’s medical history, clinical manifestations, laboratory tests, imaging examination, injury severity score (ISS), and Glasgow coma scale (GCS) were collected. The types, incidences, and clinical characteristics of shock in different stages after polytrauma were analyzed, according to the diagnostic criteria of each type of shock. The differences between the groups were compared by Student’s t test, χ2 test or Mann-Whitney U test. Results:The incidence of the early and middle stage shock after polytrauma were 73.1% and 36.4%, respectively, with statistically significant difference between stages ( P<0.01). There were significant differences in the incidence of hypovolemic shock (83.6% vs. 28.4%), distributed shock (13.7% vs. 80.9%) and cardiogenic shock (3.5% vs. 6.6%) between stages (all P<0.05). The incidence of obstructive shock (8.4% vs. 9.7%, P>0.05) was similar between stages. The incidence of undifferentiated shock was 1.6% and 1.2%, respectively. There were 9.5% patients with multifactorial shock in the early stage and 14.4% in the middle stage. Totally 7 combinations of multifactorial shock were found in different stages after polytrauma. In the early stage, the combination of HS and DS accounted the highest ratio (42.3%) and followed by HS and OS for 28.8%. In the middle stage, the combination of HS and DS was the most common (48.6%) and followed by DS and OS (24.3%). Conclusions:The incidence of shock in polytrauma patients is high. Different types of shock can occur simultaneously or sequentially. Therefore a comprehensive resuscitation strategy is significant to improve the success rate of treatment.
10.Establishment of Shanghai Suburban Adult Cohort and Biobank
Qi ZHAO ; Xing LIU ; Yonggen JIANG ; Na WANG ; Dongli XU ; Wen CHEN ; Yiling WU ; Hongjie YU ; Feng JIANG ; Jianhua SHI ; Yu XIANG ; Na HE ; Genming ZHAO
Chinese Journal of Epidemiology 2023;44(1):28-33
Urbanization has increased the population density and exposure to environmental risk factors, accelerated changes of people's lifestyles and aggravated population health disparities. A general population cohort in eastern China, Shanghai Suburban Adult Cohort and Biobank (SSACB), was established to understand the incidence and prevalence of chronic and non-communicable diseases, and identify environmental, lifestyle, and genetic risk factors in adults (aged 20-74 years old) living in the suburban of Shanghai, where urbanization process is rapid, and provide evidence for the precise prevention and control of chronic diseases. The cohort study was launched by School of Public Health,Fudan University depended on "Discipline Construction Project Shanghai Peak for Public Health and Preventive Medicine". Four districts in Shanghai, i.e. Songjiang, Jiading, Minhang and Xuhui, were selected. A total of 69 116 permanent residents aged 20-74 years were recruited. Epidemiological investigation, physical examination and laboratory tests were conducted to collect the basic information of the study subjects. Blood and urine samples were collected from them to establish a biobank. An information platform was established, from which the baseline data of the study subjects in electronic medical record system, chronic disease management system, cancer registry, infectious disease reporting system, and death registry can be shared. This paper introduces the design concept, process and future plan of SSACB.

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