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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 investigate the surgical strategy of posterior correction of cervicothoracic scoliosis in children and adolescents, and to analyze the curative effect of surgical correction.Methods:A retrospective study was conducted on 14 patients with cervicothoracic scoliosis who underwent surgical treatment in the department of spine surgery of our hospital from January 2014 to June 2020, including 9 female and 5 male patients. 8 patients were treated with Halo traction before surgery.Among them, 7 patients were treated by posterior column osteotomy and fusion surgery, 7 patients were treated byposterior approach hemivertebra osteotomy. The scoliosis Cobb angle, T 1 tilt angle, clavicle angle, neck tilt angle, shoulder height difference, sagittal balance distance, coronal balance distance and local kyphosis angle were measured compared among before operation, after operation, at 1 year follow-up and at the last follow-up to evaluate the effect of surgical treatment and the correction loss at follow-up. Intraoperative and postoperative complications were recorded, and the Scoliosis Research Society question naires-22 (SRS-22) questionnaire was completed preoperatively and at 24-month follow-up to evaluate the functional status and treatment effect. Results:All 14 patients successfully completed the operation, the operation time was 6.85±1.79 h (range, 5-11 h); the intraoperative blood loss was 685.71±265.61 ml (range, 400-1 200 ml), and the follow-up time was 37.28±13.75 months (range, 24-72 months). The Cobb angle of the main curve was 50.20°±15.19° preoperatively, 10.91°±6.46° postoperatively , 10.53°±6.42° at 1-year follow-up, and 10.14°±5.95° at the last follow-up, and the difference was statistically significant ( F=45.55, P<0.001), the preoperative and postoperative difference was statistically significant ( t=10.62, P<0.001) with a correction rate of 78.32%±11.41%. The T 1 inclination angle was 16.08°±8.06° before operation, 3.71°±2.40° after operation, 4.05°±1.94° at 1-year follow-up, and 3.97°±2.04° at the last follow-up, and the difference was statistically significant ( F=10.55, P=0.001), the preoperative and postoperative difference was statistically significant ( t=6.37, P<0.001) with a correction rate of 69.56%±25.86%. The neck tilt angle was 7.45°±3.72° before operation, 2.45°±1.12° after operation, 2.75°±0.89° at 1-year follow-up, and 3.10°±2.01° at the last follow-up, and the difference was statistically significant ( F=6.65, P=0.008), in which postoperative correction rate was 57.92%±25.41%, and the difference was statistically significant ( t=4.69, P<0.001). The data of shoulder height difference before operation did not conform to normal distribution (Shapiro-Wilk test, P=0.017), it was 0.97 (0.54, 1.32) cm before operation and 0.53±0.40 cm after operation, and the postoperative correction rate was 50.17%±27.38%, the difference was statistically significant ( Z=3.18, P=0.001). The total score of SRS-22 questionnaire was increased from 4.21±0.29 preoperatively to 4.81±0.17 at 24-month follow-up ( t=7.35, P<0.001). Except for one patient with transient upper limb numbness, the other 13 patients showed no obvious intraoperative or postoperative complications. Conclusion:Both posterior column osteotomy with fusion and posterior hemivertebra osteotomy are effective in the treatment of cervicothoracic scoliosis, and the surgeon can make individual treatment plans according to different conditions.
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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: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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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 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.
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Objective To investigate the reasons of unacceptable external quality assessment results for hemoglobin A1c (HbA1c), and improve quality level.Methods At the end of February 2017, five samples of HbA1c for external quality assessment (EQA) were sent to participated laboratories by post.After testing and reporting results by laboratories , the EQA organizer made statistical analysis and sent results back to laboratories.Meanwhile , messages would be sent to participants those had unacceptable EQA results . Investigating reasons of unacceptable results in 2017 through the EQA System based on web , which was developed by National Central for Clinical Laboratories , calculating the failure rate , analyzing the concrete reasons and combining EQA failure rates with current coefficient of variation .Results The EQA failure rate on HbA1c was 11.2％and reporting rates of reasons for failures was 70.4％(126/179).In the reasons for unacceptable results , technological (27.8％,35/126) and equipment's defects (26.2％,33/126) were the main reason categories , while malfunction ( 12.7％, 16/126 ) and methods defection ( 10.3％, 13/126 ) were the main reason subclass .The unexplainable results after survey account for 8.7％( 11/126 ) .In the group for coefficient of variation ( CV ) over 2％, the percentage of laboratories that had five samples get acceptable results was higher than that of group for CV less than 2％,and the percentage of laboratories that had at most four samples get acceptable results was lower than that of group for CV less than 2％.Conclusions The result of the reasons of unacceptable external quality assessment results for HbA 1c is generally satisfactory.The laboratory, manufacturer and EQA organizers should find and solve the working problems by analyzing EQA data , to improve the testing quality.
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Objective To evaluate the results of 2017 external quality assessment for newborn hemoglobinopathyand improve the quality of disease screening .Methods Each of 26 participating laboratories testing newborn hemoglobinopathy across the country received 5 batches of quality control blood spots ( Lot 201711-201715 ) in octorber 2017.Laboratories voluntarily participated in the survey and reported the results, methods, equipments and reagents information .Clinet EQA, and Microsoft Excel 2010 were used to perform statistical analysis on the laboratory test results .The rates of accuracy ( number of correct results/total number of submitted results ) were used for evaluating the performance of laboratories . Results 24 laboratories submitted the testing results with a return rate of 80.8%(21/26).The rates of accuracy for each lot were 100%(21/21), 90.5%(19/21), 90.5%(19/21), 57.1%(12/21) and 100%(21/21 ) respectively.Conclusions The results of this external quality assessment for newborn hemoglobinopathy is generally satisfactory , except for HbBarts′and HbA2.The screening laboratories should improve their quality control system , take timely measures to correct mistakes during the analytic period and improve the accuracy of screening tests for newborn hemoglobinopathy.
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Objective To investigate the status of blood specimen acceptability for clinical chemistry tests in routine medical laboratories of China. Methods The questionnaires were assigned to the laboratories which participated in the routine chemistry exter-nal quality assessment (EQA) programs proposed by National Health Commission for Clinical Laboratory. The questionnaires included general information of participants and information about unacceptable blood specimens. Participants were required to record all the in-formation concerning unacceptable blood specimen received from 1stto 31stJuly, 2017. The data from each laboratory were reported and collected via special online system.Results A total of 866 valid questionnaires were collected.Of 15 981 752 specimens received dur-ing the data collection period unqualified 122 00 specimens were rejected with overall rejection rate of 0.076%. The main reasons for unacceptable specimens were hemolysis (33.98%), insufficient specimen quantity (10.78%) and chylemia/lipemia (10.62%). The rejected specimens were related to the original laboratories, types of container and specimen, transportation manner and operating staff of blood collection. Conclusion Certain problems existed in the receiving and management system for unqualified blood specimen in our country and remaining to be perfected. The clinical laboratories should pay more attention for pre-examination stage, including routinely monitoring unacceptable specimens, analyzing related data at the most possible granular levels, identifying the main problem and taking effective measures.
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Objective To study the mechanism of carboxypeptidase E ( CPE ) in promoting the migration of lymphocytes and their subsets through vascular endothelial cells. Methods CRISPR/Cas9 technology was used to prepare cpe gene-knockout MS1 (Cpe-/-MS1) cells. Adhesion ability of lymphocytes to MS1 and Cpe-/-MS1 cells was analyzed with adhesion assay. Expression of adhesion molecules on these cells were detected by RT-PCR and flow cytometry. Transwell model was used to compare the difference in the transmigration of lymphocytes and their subsets through MS1 and Cpe-/-MS1 cells. Results Cpe-/-MS1 cells were successfully obtained. Under the stimulation of TNF-α, the adhesion ability of lymphocytes to MS1 cells was much better than that of Cpe-/-MS1 cells. Moreover, adhesion molecules expressed on MS1 cells were significantly more than those on Cpe-/-MS1 cells. The percentages of lymphocytes and their sub-sets that transmigrated through MS1 cells were significantly higher than those through Cpe-/-MS1 cells. Con-clusion CPE involved in the adhesion of lymphocytes to vascular endothelial cells and the transmigration of them through vascular endothelial cells, which was of great significance for understanding the migration of lymphocytes across vascular endothelial cells to peripheral lymph nodes.