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Objective:To analyze the implementation of the external quality assessment plan for quality indicators of clinical laboratories in China from 2016 to 2021, as well as that of the external quality assessment of 15 quality indicators in clinical laboratories, in order to provide reference for quality management of clinical laboratory specialties.Methods:The research data was collected from the external quality assessment plan for quality indicators, which was conducted by the National Center for Clinical Laboratories joining the clinical laboratory centers of 31 provinces (autonomous regions and municipalities directly). The essential information reported by each participating clinical laboratory from 2016 to 2021 and the external quality assessment data of 15 quality indicators in clinical laboratories were collected, followed by a descriptive analysis on the number of participating laboratories and the number of returns for each indicator. Median representation was used for the external quality assessment data of 15 quality indicators in clinical laboratories, and the TOPSIS method was applied to comprehensively evaluate the quality of the total testing process of participating clinical laboratories in each year.Results:From 2016 to 2021, the number of laboratories participating in the external quality assessment plan for quality indicators of clinical laboratory increased from 7 704 to 12 142. Quality indicators in pre-analytical phases: the incorrect sample type rate, incorrect sample container rater, and incorrect fill level rate had been decreasing year by year, reaching 0, 0, and 0.005 8% in 2021, respectively. The anticoagulant samples clotted rate had decreased from 0.068 6% in 2016 to 0.042 8% in 2021, and the blood culture contamination rate from 2017 to 2021 had been 0 without exception. The pre-examination turnaround time had been shortened from 28 minutes in 2016 to 2019 to 24 minutes in 2020 and 2021. Quality indicators in analytical phases: the intra-laboratory turnaround time had been extended from 45 minutes in 2016 to 2019 to 50 minutes in 2020 and 2021. Test covered by an IQC rate had been increasing year by year, reaching 60.61% in 2021. Test with inappropriate IQC performances rate was 0 in 2020 and 2021, the test covered by an EQA-PT control rate was 100%, and unacceptable performances in EQA-PT schemes rate from 2017 to 2021 was 0. The inter-laboratory comparison rate had increased from 1.56% in 2016 to 3.00% in 2021. Quality indicators in post-analytical phases: the incorrect laboratory reports rate, critical values notification rate and timely critical values notification rate had been 0, 100%, and 100%from 2016 to 2021 respectively. The comprehensive evaluation results of TOPSIS method showed that the overall quality level of clinical laboratory testing in 2020 was the highest, with Ci value of 0.850 5, while the lowest Ci value in 2016 was 0.143 6. Conclusions:The quality of clinical laboratory testing in China has been effectively improved. Clinical laboratories should continue to strengthen their monitoring of quality indicators, especially the intra-laboratory turnover time and the inter-laboratory comparison rate, for the purposes of identifying errors, analyzing causes and taking corrective measures to improve quality.
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Objective:To establish preliminary quality specifications for emergency examination turnaround time (TAT).Methods:The National Center for Clinical Laboratories organized 31 provinces (autonomous regions and municipalities directly) and Xinjiang production and Construction Corps centers to launch a synchronous Quality Indicators (QIs)-External Quality Assessment (EQA) program and the collected data were reported via developed online EQA system. The essential information of the clinical laboratories, the data of pre-examination and intra-laboratory TAT quality indicators of emergency departments at each specialty (biochemistry, automatic immunity, three routines tests and coagulation) and four specific tests (blood potassium, troponin I/T, white blood cell count and international normalized ratio (INR)) were collected from 2019 to 2021. TAT returned the median and 90th percentile ( P90) of the specified month were calculated. The median (lower quartile, upper quartile) of the TAT returned laboratories were calculated and second result grading statistics for 2021 (2 422 tertiary hospital and 5 088 secondary hospital) were performed to understand the difference of pre-examination and the laboratory TAT between different tertiary hospitals. Results:From 2019 to 2021, there were 9 540 laboratories, 9 709 laboratories and 10 653 returned laboratories. The pre-examination TAT of each specialty was similar, and the results were relatively stable. The median distribution was about 15 (10, 30) min, and the monthly P90 distribution was about 20 (10, 30) min. The distribution results of the median intra-laboratory TAT in each specialty were as follows: automatic immunity≥biochemistry>coagulation>three routine tests. The distribution of the latest (second result in 2021) survey results of each specialty were as follows: automatic immunity 53 (30, 60) min, biochemistry 45 (30, 60) min, coagulation 30 (23, 40) min, and three routine tests 20 (11, 30) min. The median results of monthly P90 of intra-laboratory TAT were as follows: 60 min for automatic immunity and biochemistry specialty, about 38 min for coagulation specialty, and about 27 min for three routines tests. The hierarchical statistical results showed that the monthly P90 distribution of laboratory TAT of the pre-examination and intra-laboratory TAT from the tertiary hospital was higher than that of the secondary hospital. The pre-examination TAT of each specialty of the tertiary hospital/secondary hospital was as follows: biochemistry 35 (22, 60)/20 (11, 30) min, automatic immunity 33 (20, 60)/20 (10, 30) min, three routine tests 30 (20, 49)/20 (10, 30) min and coagulation 31 (20, 58)/20 (10, 30) min, the intra-laboratory TAT of each specialty of the tertiary hospital/secondary hospital was as follows: biochemistry 65 (50, 91)/60 (40, 70) min, automatic immunity 75 (55, 113)/60 (40, 90) min, three routine tests 30 (23, 38)/28 (19, 30) min and coagulation 53 (36, 72)/35 (30, 57) min. In terms of the distribution results of the median of intra-laboratory TAT of the four specific tests, 96.76% (9 484/9 801) of the blood potassium and 95.96% (8 733/9 101) of the troponin I/T medical institutions were TAT within 69 min in the laboratories, 95.34% (9 679/10 152) of the white blood cell count medical institutions were TAT within 31 min in the laboratories, and 98.85% (9 462/9 572) of the INR medical institutions were TAT within 66 min in the laboratories. Conclusions:This survey provides a preliminary quality specification for the emergency department turnaround time at each specialty. Lower quartile, median and upper quartile of the monthly P90 at the tertiary and secondary hospitals can be used to define the best, appropriate and minimum performance levels, respectively.
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Objective:To explore the relationship between AluYb8 insertion in the MUTYH gene and the risk of decreased left ventricular diastolic function in the elderly.Methods:In the retrospective analysis, 498 elderly patients with decreased left ventricular diastolic function(the disease group)and 155 people without left ventricular diastolic function(the control group)were recruited.Polymerase chain reaction was employed to analyze the genotype distribution of AluYb8 insertion in MUTYH gene.Cardiac function was measured by high-resolution color Doppler ultrasound.Results:The frequencies of the A/A, A/P and P/P genotypes were 30.1%(150/498), 48.4%(241/498)and 21.5%(107/498)in patients with decreased left ventricular diastolic function, and 27.7%(43/155), 54.8%(85/155)and 17.5%(27/155)in the control group, respectively.There were no significant differences in genotype( χ2=2.162, P=0.339)and allele frequency( χ2=1.342, P=0.794)between the two groups.Further analysis after stratification revealed that there were statistically significant differences in genotype( χ2=7.173, P=0.028)and allele frequency( χ2=8.352, P=0.015). Multivariate Logistic regression analysis showed that, in elderly patients with diabetes, P-allele carriers had a higher risk of decreased left ventricular diastolic function than non-carriers( OR=3.450, 95% CI: 1.148-10.372, P=0.027). Conclusions:AluYb8 insertion in the MUTYH gene may be associated with the risk of decreased left ventricular diastolic function in the elderly with diabetes.
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Objective:To investigate the clinical efficacy of carbomer hemorrhoid gel in the treatment of second-degree internal hemorrhoid bleeding.Methods:A total of 160 anorectal outpatients with second-degree internal hemorrhoid bleeding who received treatment in Zhuhai Hospital of Integrated Traditional Chinese and Western Medicine from January 2017 to January 2021 were included in this study. They were randomly divided into an observation group and a control group ( n = 80/group). In the observation group, carbomer hemorrhoid gel was used to plug the anus, while in the control group, a hemorrhoid suppository was used to plug the anus. All patients were treated for 7 days. Clinical efficacy was compared between the two groups. Results:After 4 days of treatment, the bleeding score in the observation group was lower than that in the control group [1(0) point vs. 2(1) points, Z = -6.70, P < 0.05). After 7 days of treatment, the bleeding score in the observation group was significantly lower than that in the control group [0(1) point vs. 1(1) point, Z = -4.73, P < 0.05]. After 4 days of treatment, there was no significant difference in the size score of the hemorrhoids between the two groups ( P > 0.05). After 4 days of treatment, the size score of hemorrhoids in the control group did not differ significantly compared with before treatment ( P > 0.05). After 4 days of treatment, the size score of hemorrhoids in the observation group differed significantly compared with before treatment ( Z = -3.16, P < 0.05). After 7 days of treatment, the size score of the hemorrhoids in the observation group was lower than that in the control group [1(1) point vs. 1(0) point, Z = -4.48, P < 0.05]. The total response rate in the observation group was significantly higher than that in the control group [97.5% (78/80) vs. 75% (60/80), Z = -4.50, P < 0.05]. Conclusion:Carbomer hemorrhoid gel is a new drug used to treat hemorrhoids. It has a new dosage form, has no stimulation to the rectum, and is safe to use. Carbomer hemorrhoid gel is highly effective on second-degree internal hemorrhoid bleeding and deserves clinical popularization.
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Cellular senescence is a biological process associated with the degeneration of cell structure and function, which contribute to age-related diseases. Atherosclerosis is a chronic inflammatory disease that can cause a variety of cardiovascular disorders. In this article, we review the effects of cellular senescence on the development of atherosclerosis through diverse physiopathological changes, focusing on the alterations in senescent organelles and the increased senescence-associated secretory phenotype (SASP), and exploring the relevant therapeutic strategies for atherosclerosis by clearing senescent cells and reducing SASP, to provide new insights for the treatment of atherosclerosis.
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Humans , Aging , Atherosclerosis , Cardiovascular Diseases , Cellular Senescence , Chronic Disease , Senescence-Associated Secretory PhenotypeABSTRACT
Objective:An on-line calculator for calculating the frequency of internal quality control is recommended to select quality control procedures and appropriate run lengths for general chemistry in Beijing Tongren Hospital.Methods:The cumulative controlled coefficient of variations of 10 general chemical tests in the laboratory department of Beijing Tongren Hospital for 19 consecutive months were used as the imprecision. The mean value of absolute percentage difference between the quality control results and the target value of 15 batches of 10 tests in the external quality assessment (EQA) general chemistry in 2018 was used to estimate the Bias of each test. Use the allowable range of EQA target value of the National Center for Clinical Laboratories in 2018 to estimate the total allowable error (TEa) of each test. The data were input into the Westgard internal quality control frequency calculator, and 10 different candidate statistical quality control (SQC) procedures and corresponding run lengths were calculated online, including single rule and multiple rule, number of quality control concentration levels (or test projects) ranging from 1 to 4. The SQC program with relatively simple quality control rules and long run length was selected according to the actual situation of the laboratory.Results:The 1 3s, N=3 or 1 3s, N=2 rule could be adopted for ALP and CR, and the corresponding run length was 1000. TBIL and ALT projects can adopt 1 3s, N=3 or 1 3s, N=2 rule and its corresponding run length; UA can use multiple rules 1 3S/2 2S/R 4s/4 1s, N=4 (run length 395) or 1 3S/(2of3) 2S/R 4s/3 1s N=3 (run length 259); CHO, AST and AMY can adopt two multiple rules 1 3S/2 2S/R 4s/4 1s, N=4 or 1 3S/(2of3) 2S/R 4s/3 1s, N=3 and their corresponding run length. GGT project can adopt 1 3S/2 2S/R 4s/4 1S, N=4 rule (run length 50); The run length of 10 candidate quality control rules calculated by LDH was too short, the detection performance should be improved preferentially, and the quality control rules and corresponding run length were not recommended for the time being. Conclusion:The Westgard internal quality control frequency online calculator is easy to operate. Clinical laboratories can use this calculator to select SQC program and appropriate run length. It is recommended that laboratories adjust SQC program according to the current actual situation.
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Objective:By reviewing and analyzing the results of external quality assessment of pre-test quality indicators related to the acceptability of microbiology laboratory sample from 2016-2021, we aimed to understand the acceptability of microbiology laboratory sample and therefore to provide a reference for establishing preliminary quality specifications.Methods:The National Center for Clinical Laboratories organized 31 provinces (including autonomous regions and municipalities directly under the Central Government) and the Xinjiang production and Construction Corps centers to launch a synchronous Quality Indicators (QIs)-External Quality Assessment (EQA) program and the collected data were reported via an online EQA system. The essential information of the clinical laboratories and the data of quality indicators from 2016 to 2021 were collected and the data from overall, continuous return laboratories were analyzed. Sigma values were calculated to assess the quality level of laboratory.Results:The median of the 13 quality indicators of national laboratories for all years was 0 (except for the first microbiological contaminated sample rate in 2018). Ten of the quality indicators (incorrect fill level rate, sample loss rate, misidentified sample rate, unsuitable sample for storage rate before analysis, sample damaged rate during transportation, sample transported at inappropriate temperature rate, sample with excessive transportation time rate, inappropriate time in sample collection rate, sample recollection rate for error due to laboratory staff, sample recollection rate for error not due to laboratory staff) had quartiles of 0 for all years, reaching six sigma level. The results of the median (upper quartile) of each year of the three quality indicators of continuous return laboratories for tertiary hospitals show that the incorrect sample container rate was the lowest, followed by the incorrect sample type rate, and the microbiological contaminated sample rate was the highest. The highest values of corresponding median (upper quartile) results were 0.047% (0.191%), 0.059% (0.252%), 0.251% (0.6%) respectively. The median incorrect sample type rate and median incorrect sample container rate in 2016/1 and 2021/1 tertiary hospitals were ranked by province respectively. The median for the incorrect sample type rate of Liaoning, Hebei, Jiangxi, Tianjin, Beijing, Guizhou, Gansu, Qinghai and Ningxia tertiary hospitals in 2021/1 was significantly lower than the respective values in 2016/1, and the median for incorrect sample container rate of Liaoning, Sichuan, Zhejiang, Hubei, Shanxi, Tianjin, Chongqing, Guizhou, Ningxia and Hunan tertiary hospitals in 2021/1 was significantly lower than those respective values in 2016/1.Conclusions:The results of the sample acceptability of microbial laboratory are generally acceptable. The laboratories should explore and establish their own quality indicators system, strengthen the long-term monitoring of key quality indicators and improve their service quality.
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Objective:Patient risk-based statistical quality control (SQC) program was designed for 9 specific protein projects using Westgard sigma rules with run length.Methods:The cumulative coefficient of variation of immunoglobulin (Ig)G, IgA, IgM, C3, C4, rheumatoid factor (RF), antistreptolysin O (ASO), transferrin (TRF) and prealbumin (PA) from the laboratory department of Beijing Tongren Hospital between December 2018 to May 2019 were used as the estimated value of imprecision. The mean of the absolute value of the percentage difference of 10 batches in the laboratory, which was derived from the results of participating the external quality assessment (EQA), was used as the estimated value of bias. The National Center for Clinical Laboratories EQA evaluation criteria was used as an allowable total error (TEa), and the sigma value of each project (σ) was calculated. Westgard Sigma rule with run length was used to design appropriate SQC program for each project, including quality control rules, number of control measurements (N) and frequency of quality control.Results:The sigma value was larger than 6 for SQC procedure of IgG, IgA, IgM, C4 and TRF. SQC could be established with the use of 1 3s rule, number of control measurements (N)=2, number of runs (R)=1, and a run length of 1 000 patient samples. Combined with the average daily workload, internal quality control could be conducted once every 10 days for IgG, IgA, IgM and C4, every 50 days for TRF. The σ was 5.86 for C3, SQC program could be established with run length of 450 using 1 3S/2 2S/R 4s rule (N=2, R=1), combined with average daily workload, internal quality control could be conducted every 4.5 days. σ was between 3 and 4 for RF, ASO and PA. With the use of 1 3S/2 2S/R 4s/4 1s/6 X rule (N=6, R=1), SQC program with a run length of 45 and higher frequency internal quality control activities. Conclusion:It is feasible to use Westgard sigma rules with run length for the laboratories design of personalized risk-based SQC procedures, the method is very simple and intuitive. This tool is valued to be recommended to be actively applied by all clinical laboratories.
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Objective:To investigate the use of the reference intervals for blood cell counting and the reference of industry standard in China.Methods:Information from all laboratories was collected using online questionnaire in 18 reference intervals survey in blood cell counting in 2019. The information includes the source of the reference intervals, the verification of the reference intervals, and the upper and lower limits of the reference intervals, the method used, the instrument, the reagent and the calibrator. Microsoft Excel 2007 software was used to analyze the results of all laboratories. The median and 95% confidence interval were calculated. The distribution of the reference intervals for blood cell counting and their conformance to industry standards were analyzed.Results:2, 869 labs reported the data. The main sources were industry standards and National Guide to Clinical Laboratory Procedures. The proportion was 33.30%-35.02% and 28.55%-30.90% respectively. 49.44%-55.13% of laboratories validated the reference interval when citing industry standards. The reference interval grouping of most laboratories (89.37%-91.69%) cited in RBC, Hgb and Hct were consistent with the industry standards. We compared the upper and lower limits of the reference intervals with that given by the industry standards, when the lower limit of the reference intervals of mean corpuscular hemoglobin concentration, absolute neutrophils count, absolute basophils count, absolute monocyte count, and lymphocyte percentage were compared. The upper limit of reference intervals of neutrophils percentage as well as upper and lower limits of reference intervals of mean corpuscular volume, mean corpuscular hemoglobin, absolute eosinophil count, basophils percentage, and monocyte percentage were also compared. The median and mode were equal and consistent with industry standards. For other labs, the upper and lower limits of the reference intervals were not consistent with the reference intervals given by the industry standards.Conclusion:The use of reference intervals for blood cell counting was not the same, and the implementation of industry standards was not optimistic. A considerable number of laboratories had not verified the reference intervals, so it was necessary to promote the industry standards for reference intervals.
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Events including antibody‒antigen affinity, internalization, trafficking and lysosomal proteolysis combinatorially determine the efficiency of antibody-drug conjugate (ADC) catabolism and hence the toxicity. Nevertheless, an approach that conveniently identifies proteins requisite for payload release and the ensuing toxicity for mechanistic studies and quality assessment is lacking. Considering the plethora of ADC candidates under development, we developed a target-responsive subcellular catabolism (TARSC) approach that examines ADC catabolism and probes changes in response to targeted interferences of proteins of interest. We firstly applied TARSC to study the commercial T-DM1 and the biosimilar. We recorded unequivocal catabolic behaviors regardless of the absence and presence of the targeted interferences. Their negligible differences in TARSC profiles agreed with their undifferentiated anti-tumoral efficacy according to further
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RNF20, an E3 ligase critical for monoubiquitination of histone H2B at lysine 120 (H2Bub), has been implicated in the regulation of various cellar processes; however, its physiological roles in adipocytes remain poorly characterized. Here, we report that the adipocyte-specific knockout of Rnf20 (ASKO) in mice led to progressive fat loss, organomegaly and hyperinsulinemia. Despite signs of hyperinsulinemia, normal insulin sensitivity and improved glucose tolerance were observed in the young and aged CD-fed ASKO mice. In addition, high-fat diet-fed ASKO mice developed severe liver steatosis. Moreover, we observed that the ASKO mice were extremely sensitive to a cold environment due to decreased expression levels of brown adipose tissue (BAT) selective genes, including uncoupling protein 1 (Ucp1), and impaired mitochondrial functions. Significantly decreased levels of peroxisome proliferator-activated receptor gamma (Pparγ) were observed in the gonadal white adipose tissues (gWAT) from the ASKO mice, suggesting that Rnf20 regulates adipogenesis, at least in part, through Pparγ. Rosiglitazone-treated ASKO mice exhibited increased fat mass compared to that of the non-treated ASKO mice. Collectively, our results illustrate the critical role of RNF20 in control of white and brown adipose tissue development and physiological function.
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Objective:To explore mechanism of how nurse managers' transformational leadership affects patient satisfaction, and to examine the mediating role of nurses' psychological empowerment.Methods:A total of 140 nurses and 310 patients in Sun Yat-sen University Cancer Center were surveyed. The Leadership Practice Inventory-other, the Psychological Empowerment Scale and two items from the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (Chinese version) were used to measure nurse-perceived nurse managers' transformational leadership behaviors, nurses' psychological empowerment and patient satisfaction. The descriptive statistics and correlation analysis were performed using the SPSS 20.0. software package, and the structure equation modeling was performed using the MPlus 7.0.Results:Higher frequencies of nurse managers adopting transformational leadership were associated with higher level of nurses' psychological empowerment ( β=0.665, P < 0.05); higher level of nurses' psychological empowerment was associated with higher overall patient satisfaction ( β=0.243, P < 0.05); nurses' psychological empowerment mediated the relationship between nurse managers' transformational leadership and patients' overall satisfaction ( β=0.162, P=0.014); the effects of nurse managers' transformational leadership and nurses' psychological empowerment on patients' recommendation of hospital were not statistically significant ( P>0.05). Conclusions:Nurse managers are encouraged to adopt transformational leadership, i.e., improving clinical and leadership skills, trying to be nurses' role model, solving problems at work, empowering and motivating nurses, thus to increase nurses' senses of empowerment, and to improve patient satisfaction eventually.
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Tricalcium phosphate (TCP) is one of the most widely used bioceramics for constructing bone tissue engineering scaffold. The three-dimensional (3D) printed TCP scaffold has precise and controllable pore structure, while with the limitation of insufficient mechanical properties. In this study, we investigated the effect of sintering temperature on the mechanical properties of 3D-printed TCP scaffolds in detail, due to the important role of the sintering process on the mechanical properties of bioceramic scaffolds. The morphology, mass and volume shrinkage, porosity, mechanical properties and degradation property of the scaffold was studied. The results showed that the scaffold sintered at 1 150℃ had the maximum volume shrinkage, the minimum porosity and optimal mechanical strength, with the compressive strength of (6.52 ± 0.84) MPa and the compressive modulus of (100.08 ± 18.6) MPa, which could meet the requirements of human cancellous bone. In addition, the 1 150℃ sintered scaffold degraded most slowly in the acidic environment compared to the scaffolds sintered at the other temperatures, demonstrating its optimal mechanical stability over long-term implantation. The scaffold can support bone mesenchymal stem cells (BMSCs) adherence and rapid proliferation and has good biocompatibility. In summary, this paper optimizes the sintering process of 3D printed TCP scaffold and improves its mechanical properties, which lays a foundation for its application as a load-bearing bone.
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Objective@#To explore mechanism of how nurse managers' transformational leadership affects patient satisfaction, and to examine the mediating role of nurses' psychological empowerment.@*Methods@#A total of 140 nurses and 310 patients in Sun Yat-sen University Cancer Center were surveyed. The Leadership Practice Inventory-other, the Psychological Empowerment Scale and two items from the Hospital Consumer Assessment of Healthcare Providers and Systems Survey (Chinese version) were used to measure nurse-perceived nurse managers' transformational leadership behaviors, nurses' psychological empowerment and patient satisfaction. The descriptive statistics and correlation analysis were performed using the SPSS 20.0. software package, and the structure equation modeling was performed using the MPlus 7.0.@*Results@#Higher frequencies of nurse managers adopting transformational leadership were associated with higher level of nurses' psychological empowerment (β=0.665, P < 0.05); higher level of nurses' psychological empowerment was associated with higher overall patient satisfaction (β=0.243, P < 0.05); nurses' psychological empowerment mediated the relationship between nurse managers' transformational leadership and patients' overall satisfaction (β=0.162, P=0.014); the effects of nurse managers' transformational leadership and nurses' psychological empowerment on patients' recommendation of hospital were not statistically significant (P>0.05).@*Conclusions@#Nurse managers are encouraged to adopt transformational leadership, i.e., improving clinical and leadership skills, trying to be nurses' role model, solving problems at work, empowering and motivating nurses, thus to increase nurses' senses of empowerment, and to improve patient satisfaction eventually.
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The laboratory medicine is aimed to support clinical decisions and patient health by providing accurate results. The internal statistical quality control (SQC) can help laboratories detecting the instability of the analytical system and preventing laboratories from reporting the patient results with medically important errors, so it is essential to ensure the quality of testing results and patient safety. The traditional methods of designing SQC strategy are based on the probability of error detection (Ped) and the probability of false rejection (Pfr). With the introduction of risk management concepts, the design of SQC strategy began to be based on the patient risk parameter [MaxE(Nuf)] proposed by Parvin, which means the maximum increase in the number of unacceptable patient results reported compared to the in-control condition during the existence of an undetected out-of control error condition. MaxE(Nuf) is related to the SQC frequency and patient risk, which is very essential for optimizing the SQC frequency and designing a risk-based SQC strategy.
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The laboratory medicine is aimed to support clinical decisions and patient health by providing accurate results. The internal statistical quality control (SQC) can help laboratories detecting the instability of the analytical system and preventing laboratories from reporting the patient results with medically important errors, so it is essential to ensure the quality of testing results and patient safety. The traditional methods of designing SQC strategy are based on the probability of error detection (Ped) and the probability of false rejection (Pfr). With the introduction of risk management concepts, the design of SQC strategy began to be based on the patient risk parameter [MaxE(Nuf)] proposed by Parvin, which means the maximum increase in the number of unacceptable patient results reported compared to the in-control condition during the existence of an undetected out-of control error condition. MaxE(Nuf) is related to the SQC frequency and patient risk, which is very essential for optimizing the SQC frequency and designing a risk-based SQC strategy.
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Objective To investigate the expression of long non-coding RNA (lncRNA)H19 in gallbladder cancer and its relationship with clinicopathological parameters and prognosis.Methods 74 cases of allbladder cancer resected in our hospital were collected and studied.At the same time,66 cases of benign gallbladder lesions were selected as benign lesion group.The expression of lncRNA H19 in tissues was detected by real-time fluorescence quantitative polymerase chain reaction (qRT-PCR).The correlation between lncRNA H19 expression and clinicopathological parameters of gallbladder cancer patients was analyzed.The patients were followed up for 3 years and COX was used to analyze the prognostic factors affecting the survival rate.The survival was analyzed by Kaplan-Meier curve.The survival differences of lncRNA H19 expression groups were detected by Log-Rank method.Results The expression level of lncRNA H19 in gallbladder cancer was significantly higher than that in benign lesions (P ＜ 0.05).The expression of lncRNA H19 was correlated with stage,differentiation and lymph node metastasis (P ＜ 0.05).Age,sex,histological grade,stage and depth of invasion of gallbladder cancer had no significant correlation with 3-year survival rate (P ＞ 0.05).The survival rate of patients with differentiated tumors and non-metastatic lymph nodes were higher (P ＜ 0.05).The survival rate of patients with low expression of lncRNA H19 was significantly higher than those with high expression of lncRNA H19 (P ＜ 0.05).Tumor differentiation,lymph node metastasis and lncRNA H19 expression were independent risk factors affecting the prognosis of patients with gallbladder cancer.Conclusions LncRNA H19 is highly expressed in gallbladder cancer,which is closely related to the degree of differentiation,lymph node metastasis and survival rate of patients.
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Objective@#To investigate the expression of long non-coding RNA (lncRNA)H19 in gallbladder cancer and its relationship with clinicopathological parameters and prognosis.@*Methods@#74 cases of allbladder cancer resected in our hospital were collected and studied. At the same time, 66 cases of benign gallbladder lesions were selected as benign lesion group. The expression of lncRNA H19 in tissues was detected by real-time fluorescence quantitative polymerase chain reaction (qRT-PCR). The correlation between lncRNA H19 expression and clinicopathological parameters of gallbladder cancer patients was analyzed.The patients were followed up for 3 years and COX was used to analyze the prognostic factors affecting the survival rate.The survival was analyzed by Kaplan-Meier curve. The survival differences of lncRNA H19 expression groups were detected by Log-Rank method.@*Results@#The expression level of lncRNA H19 in gallbladder cancer was significantly higher than that in benign lesions (P<0.05). The expression of lncRNA H19 was correlated with stage, differentiation and lymph node metastasis (P<0.05). Age, sex, histological grade, stage and depth of invasion of gallbladder cancer had no significant correlation with 3-year survival rate (P>0.05). The survival rate of patients with differentiated tumors and non-metastatic lymph nodes were higher (P<0.05). The survival rate of patients with low expression of lncRNA H19 was significantly higher than those with high expression of lncRNA H19 (P<0.05). Tumor differentiation, lymph node metastasis and lncRNA H19 expression were independent risk factors affecting the prognosis of patients with gallbladder cancer.@*Conclusions@#LncRNA H19 is highly expressed in gallbladder cancer, which is closely related to the degree of differentiation, lymph node metastasis and survival rate of patients.
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Objective To investigate and analyze the source and upper and lower limits of the reference interval of children's complete blood count in 110 maternal and child health hospitals and chil-dren's hospitals nationwide. Methods Laboratories submitted the data of reference intervals via external quality assessment (EQA) software which was based on the web. To collect the results of reference intervals questionnaires on complete blood cell counting of children in laboratory departments of 110 maternal and child care service centers and children's hospitals in China in 2017. Questionnaires include information on the source of reference intervals for 18 items of complete blood count, whether to verify, upper and lower lim-its, grouping, methods used, instruments, reagents, and calibrators. Data was analyzed using Microsoft Excel 2007 and SPSS 22.0. The median, P25, P75were obtained, and rank sum test were used to determine wheth-er there were statistical differences between groups. Results The results of 110 laboratories were obtained after rejecting invalid data. The reference intervals were mainly derived from operating procedures and the laboratories themselves, of which 50.5％-53.6％ of the laboratories were validated. The white blood cell counting reference intervals gradually decreased from birth to adolescence, and the value was close to that of adults. The reference intervals of red blood cell counting and hemoglobin were close to that of adults except in the neonatal period. The value of the reference intervals of hematocrit slightly decreased with age. The dif-ference between RBC, Hgb, HCT in reference intervals between groups was statistically significant when grouped by gender(P<0.05). The reference intervals of white blood cell counting were less grouped by gender (5 laboratories), and the difference among groups was not statistically significant. There were no statistically significant differences in the reference intervals of elements between the two measurement systems that Sys-mex XN series and Sysmex XS-800i/XS-1000i/XS 500i/XS 900i series. Conclusions The establishment of reference intervals for children's complete blood cell counting was urgently needed. The reference inter-vals of the complete blood cell counting item had statistical significance in both age and gender. It was sug-gested that the industry standard of children's complete blood cell counting reference intervals should be es-tablished based on age and gender.
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Objective To eva1uate the external quality assessment results of prenatal screening for maternal serum inhibin A in the second trimester in 2018 and to improve the accuracy of prenatal screening.Methods National Center for Clinical Laboratories provided three batches of quality control urine sample (Lot:201811-201813) to 94 prenatal screening laboratories nationwide in March 2018.Laboratories participated in the assessment voluntarily and reported the results,methods,equipment,reagents and other related information as required.Clinet EQA and Microsoft Excel 2010 were used for statistical analysis of the laboratory test results and for descriptive evaluation of the accuracy rate.Results A total of 55 laboratories submitted their testing results giving a return rate of 58.5％ (55/94),of which 52 (94.5％) were consistent with the expected results,while none of the results submitted by the other three laboratories was accurate.At the mean time,the bias of all three batches in each laboratory fell into the same side (two laboratories showed negative bias and one positive bias).Conclusions The results of the external quality assessment of prenatal screening for maternal serum inhibin A are generally satisfactory except for a few laboratories.It is necessary to incorporate prenatal screening for maternal serum inhibin A in the second trimester into the formal external quality assessment plan and regularly monitor the level of its detection quality.