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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: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 status of clinical laboratory construction in China and evaluate its completeness, adequacy and effectiveness.@*Methods@#An electronic investigation on laboratory construction was conducted in March 2019. The questionnaires were synchronously distributed to 14 055 laboratories covering 31 provincial administrative units in China. Excel 2010 and SPSS 20 were used for analysis of four main indicators: gross area, total equipment value, human resource, and testing items. Descriptive statistics were demonstrated and comparisons of the indicators among different types of laboratories were checked with the Kruskal-Wallis test.@*Results@#A total of 9 966 valid questionnaires were returned, with an effective recovery of 70.9%. The overall median of the four indicators were respectively: gross area(344.5 square meters), total equipment value(RMB 4.15 million), staff number(12) and testing item number(160). The difference of all four indicators among various types of laboratories was significant(P<0.05).@*Conclusions@#The construction of laboratories in primary hospitals and private hospitals is not satisfying, especially the equipment and human resource. More attention on the awareness to improve clinical laboratory construction for further quality improvement and patient safety is needed.
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Objective To investigate the status of clinical laboratory construction in China and evaluate its completeness,adequacy and effectiveness.Methods An electronic investigation on laboratory construction was conducted in March 2019.The questionnaires were synchronously distributed to 14 055 laboratories covering 31 provincial administrative units in China.Excel 2010 and SPSS 20 were used for analysis of four main indicators:gross area,total equipment value,human resource,and testing items.Descriptive statistics were demonstrated and comparisons of the indicators among different types of laboratories were checked with the Kruskal-Wallis test.Results A total of 9 966 valid questionnaires were returned,with an effective recovery of 70.9％.The overall median of the four indicators were respectively:gross area(344.5 square meters),total equipment value (RMB 4.15 million),staff number(12) and testing item number(160).The difference of all four indicators among various types of laboratories was significant (P ＜ 0.05).Conclusions The construction of laboratories in primary hospitals and private hospitals is not satisfying,especially the equipment and human resource.More attention on the awareness to improve clinical laboratory construction for further quality improvement and patient safety is needed.
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Objective To investigate the incidence of insomnia and its influencing factors in the outpatients with cardiovascular diseases in a general hospital.Methods A total of 956 consecutive cases of the outpatients was collected from March 2016 to September in the department of cardiology patients in this general hospital.Insomnia was diagnosed with the 2012 Chinese adult insomnia diagnosis and treatment guidelines.All subjects underwent clinical examination,generalized anxiety scale (GAD-7),patient health questionnaire depression scale (PHQ-9),and self-made demographic sociology information questionnaire.Results A total of 925 patients with completed data was included in the analysis data.The insomnia incidence rate was 51.4％.The insomnia incidence rates were 57.8％ and 37.6％ in the patients with and without cardiovascular diseases.The difference was statistically significant (P ＜ 0.01) between both groups.The insomnia incidence rates in the patients with hypertension,coronary heart disease,arrhythmia,hypertension combined with coronary heart disease and other cardiovascular diseases were 50.8％,56.3％,53.2％,63.0％,and 54.3％,respectively.There were significant differences between the groups (P ＜ 0.05).The incidence of anxiety or depressive symptoms was 44.5％ in all investigators.Insomnia incidence rates were 75.6％ and 32.0％ in the subjects with and without anxiety or depressive symptoms.The difference was statistically significant (P ＜ 0.01) between both groups.Multivariate logistic regression analysis showed that gender,type A personality,family income satisfaction,cardiovascular diseases and anxiety/depression were independent factors to affect the occurrence of insomnia.Conclusions The insomnia incidence rates was high in the outpatients from the department of cardiology of general hospital.The main factors that affect the occurrence of insomnia include psychological,social aspects,and cardiovascular diseases.
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Objective To investigate the 15 quality indicators at medical institutions in China , and to explore the model of quality specifications .Methods Online questionnaires were sent to 8029 clinical laboratories ,with the results analyzed by SPSS 20 .The 25th percentile ,50th percentile ,and 75th percentile of the distribution ,according to the level of the hospital ,were regarded as the optimum , appropriate and minimum quality specifications for each quality indicator ,respectively .Results As shown in the median ,sigma values of most indicators were greater than 3 .The defect percentages of test uncovered by internal quality control (IQC)and test uncovered by inter-laboratory comparison were 47.46％ and 85.73％ ,respectively ,both too poor to calculate the sigma values. The turnaround time (TAT )differed greatly among the subjects.The longest time of pre-examination TAt and Intra-laboratory TAT were clinical immunity. The minimum quality specifications for the quality indicators were from 3σ to 6σ.Conclusions Laboratories should strengthen their IQc and inter-laboratory comparison with continuing education training to realize the continuous quality improvement .
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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 investigate an evaluation program for external quality assessment ( EQA) of quality indicators ( QIs) and develop a software .Methods According to GB/T 27043-2012 ( ISO/IEC 17043:2010,IDT) mode 3, 28 provincial centers for clinical Laboratories were organized by National Center for Clinical Laboratories to launch an investigation on “QIs in clinical laboratory” with the use of Clinet-EQA online .Participants were asked to collect data of April 2014 and report related results online .Mean, median, the 5 th, 25 th, 75 th and 95 th percentiles of defectpercentages for biochemistry , immunology, blood and body fluid and microbiology were calculated , respectively .Sigma values were also calculated . Meanwhile , 25 th of sigma value and 75 th of defect percentages were chosen as preliminary quality specifications for each QI so that laboratories can evaluate related process quality .Results Take incorrect sample type rates for example , 4 771 laboratories were involved in this study .Among four subjects , incorrect sample type rates were lowest (0.01%, 6σ) for immunology tests, followed by blood and body fluids tests (0.06%, 4.7σ) and biochemistry tests (0.06%, 4.7σ), and were highest for microbiology tests (0.33%, 4.2σ).Evaluation reports will besent back to participants so that they can understand national , provincial , and their own sigma levels well .Preliminary quality specifications of incorrect sample type for biochemistry, immunology, blood and body fluid, and microbiology tests were 0.08% (4.6σ), 0.03%(5σ), 0.09%(4.6σ) and 0.43%(4.1σ), respectively.Conclusion Clinical laboratories were advised to establish and monitor suitable QIs within laboratory and participate in QIs EQA schemes , thus they can improve their quality continuously .
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Objective To establish and apply the procedure of survey on quality indicator in clinical laboratory and to analyze the status in quo of the 15 quality indicators in Zhejiang province .Methods A network platform for the survey on quality indicator in clinical laboratory was designed and developed by our center.The online questionnaires that should be reported back within one month were assigned to 473 laboratories.The developed software and SPSS 13.0 were used for statistical analysis .13 indicators expressed in rate were further evaluated with sigma scales .The 25th percentile, 50th percentile, and 75th percentile of the distribution of each quality indicator were regarded as the minimum , appropriate and optimum quality specifications, respectively.Results Totally 444 laboratories submitted the survey results.The overall sigma levels of 10/13 indicators were all >3, of which the inappropriate CV of internal quality control and unacceptable performances in EQA were still less than 3σin 15.8%and 9.2%of the laboratories.The rates of quality indicators in different scales of laboratories and diverse disciplines were significantly different .Pre-analytical TAT in routine examination for clinical chemistry and immunology was 50 min, on average.And the time for routine examination of blood , urine and stool was 30 min.Pre-analytical TAT in emergency examination for all four disciplines were all between 10 and 15 min. Intra-analytical TAT for clinical immunology was the longest , which was 154 min for routine examination and 40 min for emergency examination, respectively.The optimum quality specifications for 8 indicators were 6σ, while the minimum quality specifications were less than 1σfor 4 indicators.Conclusions According to the results of our survey, the pre-analytical quality indicator perform better than that of Intra-analytical and post-analytical phase.The laboratory should strengthen the laboratory information system technology construction to ensure the reliable data collection and long-time monitoring.