Kun Zhong

National survey on intra-laboratory turnaround time for some most common routine and stat laboratory analyses in 479 laboratories in China.

Introduction To investigate the state of the art of intra-laboratory turnaround time (intra-TAT), provide suggestions and find out whether laboratories accredited by International Organization for Standardization (ISO) 15189 or College of American Pathologists (CAP) will show better performance on intra-TAT than non-accredited ones. Materials and methods 479 Chinese clinical laboratories participating in the external quality assessment programs of chemistry, blood gas, and haematology tests organized by the National Centre for Clinical Laboratories in China were included in our study. General information and the median of intra-TAT of routine and stat tests in last one week were asked in the questionnaires. Results The response rate of clinical biochemistry, blood gas, and haematology testing were 36% (479 / 1307), 38% (228 / 598), and 36% (449 / 1250), respectively. More than 50% of laboratories indicated that they had set up intra-TAT median goals and almost 60% of laboratories declared they had monitored intra-TAT generally for every analyte they performed. Among all analytes we investigated, the intra-TAT of haematology analytes was shorter than biochemistry while the intra-TAT of blood gas analytes was the shortest. There were significant differences between median intra-TAT on different days of the week for routine tests. However, there were no significant differences in median intra-TAT reported by accredited laboratories and non-accredited laboratories. Conclusions Many laboratories in China are aware of intra-TAT control and are making effort to reach the target. There is still space for improvement. Accredited laboratories have better status on intra-TAT monitoring and target setting than the non-accredited, but there are no significant differences in median intra-TAT reported by them.

The status of neonatal screening in China, 2013:

Objectives To investigate the status of neonatal screening in China in 2013. Method All Chinese neonatal screening laboratories were asked to submit information about the number of newborns screened and for which diseases, the rate of acceptable blood spots, and the time between sample collection and delivery to laboratories and reporting. Results Of the 202 laboratories, 194 (96%) submitted data. In 2013, 73.6% (142/193) of laboratories testing for phenylketonuria (PKU), 72.7% (141/194) for congenital hypothyroidism (CH), 58.9% (43/73) for glucose-6-phosphate dehydrogenase (G6PD) deficiency and 53.1% (34/64) for congenital adrenal hyperplasia (CAH) screened more than 30,000 newborns. The incidences of PKU, CH, G6PD deficiency, and CAH were 1:12189, 1:2281, 1:44 and 1:6084, respectively. The estimated coverage of screening for PKU, CH, G6PD deficiency, and CAH were 86.3 ∼ 87.5%, 87.9 ∼ 89.1%, 24.0 ∼ 25.0% and 18.9% ∼ 19.9%, respectively. The rates of acceptable blood spots were ≥98% in 161 (87.0%) of 185 laboratories. More than half the laboratories could not achieve a time from collection to reporting of 5 days. Conclusion Neonatal screening has developed rapidly in China but the biggest challenge is still to increase coverage and expand the screening disease panel across the entire country. More government support is needed to make neonatal screening more efficient.

Preliminary probe of quality indicators and quality specification in total testing process in 5753 laboratories in China.

Abstract Background: The aim of the study was to promote the establishment and implementation of quality indicators (QIs) in clinical laboratories, catch up with the state of art, and provide preliminary quality specifications for established QIs. Methods: Clinical laboratories from different provinces in China were included in this QIs survey in 2015. All participants were asked to collect data related to QIs and complete QIs questionnaires. Defect percentages and sigma values were calculated for each QI. The 25th percentile, median, and the 75th percentile of defect percentages and TATs were calculated as optimum, desirable and minimum quality specifications. While 25th, median, and 75th of sigma values were calculated as minimum, desirable and optimum quality specifications, respectively. Results: Five thousand seven hundred and fifty-three clinical laboratories from 28 provinces in China participated in this survey. Median defect percentages of pre-examination QIs varied largely from 0.01% (incorrect sample container) to 0.57% (blood culture contamination) with sigma values varied from 4.0σ to 5.1σ. Median defect percentages of examination phase QIs were all really high. The most common problem in examination phase was test uncovered by inter-laboratory comparison (86.67%). Defect percentages of critical values notification and timely critical values notification were all 0.00% (6.0σ). While the median of defect percentages of incorrect laboratory reports was only 0.01% (5.4σ). Conclusions: Improvements are needed in all phases of total testing process (TTP) in laboratories in China, especially in examination phase. More attention should be paid when microbiology specimens are collected and results are reported. Quality specifications can provide directions for laboratories to make effort for.

Imprecision Investigation and Analysis of Routine Chemistry in China

This study aims to investigate the imprecision of internal quality control of routine chemistry analytes so that we can have an overall knowledge of imprecision level of measurement in laboratories in China.

Neonatal screening external quality assessment in China, 2014

Objective To analyze the 2014 results of neonatal screening external quality assessment (EQA) performed by the Chinese National Centre for Clinical Laboratories. Methods EQA test panels consisting of five dried blood spots (three panels for phenylalanine (Phe) and thyroid stimulating hormone (TSH), two for glucose-6-phosphate dehydrogenase (G6PD) and 17-alpha-hydroxy progesterone (17-OHP)) were distributed to laboratories and the results collected and evaluated. To compare the correct recognition rates, chi-square test was used. Results Test results were received from 170 laboratories for Phe, 176 for TSH, 65 for G6PD and 65 for 17-OHP. The total number of effective quantitative and qualitative results of Phe, TSH, G6PD and 17-OHP were 2520 and 2370, 2605 and 2450, 645 and 530, 645 and 645, respectively. The overall correct recognition rates for qualitative tests of Phe, TSH, G6PD and 17-OHP were 99.79 %, 99.67 %, 93.40 % and 99.84 %, and the proportion of acceptable quantitative results were 94.48 %, 98.31 %, 84.65 % and 99.84 %, respectively. There were significant differences in the rates of acceptable quantitative results of the two measurement systems for Phe, TSH and G6PD (p<0.001); χ2 test showed significant differences in correct recognition or acceptable rates among programmes (p<0.001). Conclusion Most of the quantitative results were acceptable and the overall correct recognition rates in qualitative results approached 100%. Distributing more challenging samples and increasing the range of concentrations of EQA samples will improve standards in future assessments.

Quality specification and status of internal quality control of cardiac biomarkers in China from 2011 to 2016

This study aimed to investigate the status of internal quality control (IQC) for cardiac biomarkers from 2011 to 2016 so that we can have overall knowledge of the precision level of measurements in China and set appropriate precision specifications.

Status of internal quality control for thyroid hormones immunoassays from 2011 to 2016 in China

Internal quality control (IQC) plays a key role in the evaluation of precision performance in clinical laboratories. This report aims to present precision status of thyroid hormones immunoassays from 2011 to 2016 in China.

Reasons for Proficiency Testing Failures in Routine Chemistry Analysis in China

Objective To understand the reasons for proficiency testing (PT) failures, toward the goal of continuous improvement of laboratory services. Methods Laboratories participating in PT of routine chemistry testing provided by the National Center for Clinical Laboratories (NCCL) of China were given 3 schemes for handling PT failures in 2016. If they had unsatisfactory PT performance, they were notified and requested to investigate failure errors and submit data regarding those errors. Results Failure types were distributed as follows, per error group: Clerical, 10.2%; Methodological, 16.2%; Equipment, 23.6%; Technical, 37.4%; PT Evaluation, 0.5%; Unexplained, 11.5%; and Other, 0.7%. Reasons unique to the PT process accounted for 15.6% of all reasons. Corrective actions mainly included correcting calibration, maintaining or changing equipment, strengthening reagent management, rewriting procedures, and retraining staff members. Conclusions The causes for PT failures relate mainly to laboratory problems, not to the PT process itself. Therefore, PT sponsored by the NCCL is an effective evaluation tool for laboratory performance. Also, laboratories should strive to improve analytical performance.

Internal quality control status for BNP and NT-proBNP in China from 2014 to 2017

This study aimed to investigate and analyze the status of internal quality control (IQC) for BNP and NT‐proBNP from 2014 to 2017, so as to have an integral understanding of quality performance of measurement in clinical laboratories in China.

National surveys on internal quality control for blood gas analysis and related electrolytes in clinical laboratories of China

Abstract Background: Internal quality control (IQC) is essential for precision evaluation and continuous quality improvement. This study aims to investigate the IQC status of blood gas analysis (BGA) in clinical laboratories of China from 2014 to 2017. Methods: IQC information on BGA (including pH, pCO2, pO2, Na+, K+, Ca2+, Cl−) was submitted by external quality assessment (EQA) participant laboratories and collected through Clinet-EQA reporting system in March from 2014 to 2017. First, current CVs were compared among different years and measurement systems. Then, percentages of laboratories meeting five allowable imprecision specifications for each analyte were calculated, respectively. Finally, laboratories were divided into different groups based on control rules and frequency to compare their variation trend. Results: The current CVs of BGA were significantly decreasing from 2014 to 2017. pH and pCO2 got the highest pass rates when compared with the minimum imprecision specification, whereas pO2, Na+, K+, Ca2+, Cl− got the highest pass rates when 1/3 TEa imprecision specification applied. The pass rates of pH, pO2, Na+, K+, Ca2+, Cl− were significantly increasing during the 4 years. The comparisons of current CVs among different measurement systems showed that the precision performance of different analytes among different measurement systems had no regular distribution from 2014 to 2017. The analysis of IQC practice indicated great progress and improvement among different years. Conclusions: The imprecision performance of BGA has improved from 2014 to 2017, but the status of imprecision performance in China remains unsatisfying. Therefore, further investigation and continuous improvement measures should be taken.