ABSTRACT
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.
ABSTRACT
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 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 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.
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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 investigate the status of report appropriateness in Clinical Hematology and to identify its potential influence factors to improve the quality of laboratory reports.Methods 1 120 National External Quality Assessment ( EQA ) participants laboratories were enrolled in this study.The questionnaires were assigned to all the participants in both electronic and printed form.The participants were asked to retrospectively count the total reports and the affected reports while the following quality indicators occurred in 2012:report delay, inconformity of data between instrument and LIS as well as between report and request erroneous report transportation, report recall, and report modification.All quality indicators were evaluated in two ways:percentage and sigma (σ) scale.Mann-Whitney Test and Kruskal-Wallis Test were used to analyze the potential impacts of report appropriateness.Results Totally 609 (54.38%)laboratories submitted the survey results .The sigma metrics of six quality indicators on report appropriateness were more than 4.The main reason for report delay was equipment failure.Group comparison suggested that the report appropriateness of laboratories in tertiary-A hospitals and accredited by ISO 15189 werebetter.Report appropriateness with electronic request, electronic form and electronic transmission were superior than that inother ways. Conclusions Report appropriateness in China differs from laboratory to laboratory. Laboratories should develop emergency action plan in case the instrument breaks down and strengthen information technology .Long-term internal quality control and external quality assessment scheme are very meaningful to identify the insufficient performance and improve laboratory quality .(Chin J Lab Med, 2015,38:632-636)