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Clinical Chemistry and Laboratory Medicine (CCLM)

Published in Association with the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)

Editor-in-Chief: Plebani, Mario

Ed. by Gillery, Philippe / Greaves, Ronda / Lackner, Karl J. / Lippi, Giuseppe / Melichar, Bohuslav / Payne, Deborah A. / Schlattmann, Peter


IMPACT FACTOR 2018: 3.638

CiteScore 2018: 2.44

SCImago Journal Rank (SJR) 2018: 1.191
Source Normalized Impact per Paper (SNIP) 2018: 1.205

Online
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1437-4331
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Volume 57, Issue 2

Issues

National surveys on 15 quality indicators for the total testing process in clinical laboratories of China from 2015 to 2017

Min Duan
  • National Center for Clinical Laboratories/Beijing Engineering Research Medicine, Beijing Hospital, National Center of Gerontology, Beijing, P.R. China
  • Graduate School of Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, P.R. China
  • Other articles by this author:
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/ Xudong Ma / Jing Fan / Yanhong Guo / Wei Wang
  • National Center for Clinical Laboratories/Beijing Engineering Research Medicine, Beijing Hospital, National Center of Gerontology, Beijing, P.R. China
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/ Haijian Zhao
  • National Center for Clinical Laboratories/Beijing Engineering Research Medicine, Beijing Hospital, National Center of Gerontology, Beijing, P.R. China
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/ Yuanyuan Ye
  • National Center for Clinical Laboratories/Beijing Engineering Research Medicine, Beijing Hospital, National Center of Gerontology, Beijing, P.R. China
  • Graduate School of Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, P.R. China
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/ Yang Fei
  • Affiliated Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology, Wuhan, P.R. China
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/ Falin He
  • National Center for Clinical Laboratories/Beijing Engineering Research Medicine, Beijing Hospital, National Center of Gerontology, Beijing, P.R. China
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/ Zhiguo Wang
  • Corresponding author
  • National Center for Clinical Laboratories/Beijing Engineering Research Center of Laboratory Medicine, Beijing Hospital, National Center of Gerontology, No. 1, Dahua Road, Dongdan, Dongcheng District, Beijing 100730, P.R. China
  • Graduate School of Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing 100730, P.R. China, Phone: +86-010-58115054, Fax: +86-010-65273025
  • Email
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/ Zongjiu Zhang
  • Corresponding author
  • National Health Commission of the People’s Republic of China, No. 1, Xizhimenwai South Road, Xicheng District, Beijing 100044, P.R. China, Phone: +86-010-68792197
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  • Other articles by this author:
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Published Online: 2018-07-17 | DOI: https://doi.org/10.1515/cclm-2018-0416

Abstract

Background

As effective quality management tools, quality indicators (QIs) are widely used in laboratory medicine. This study aimed to analyze the results of QIs, identify errors and provide quality specifications (QSs) based on the state-of-the-art.

Methods

Clinical laboratories all over China participated in the QIs survey organized by the National Health Commission of People’ Republic of China from 2015 to 2017. Most of these QIs were selected from a common model of QIs (MQI) established by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC). All participants were asked to submit general information and original QIs data through a medical quality control data collection system. The results of QIs were reported in percentages and sigma, except turnaround time (TAT) which was measured in minutes. The 25th, 50th and 75th percentiles were, respectively, calculated as three levels of QSs, which were defined starting from the model proposed during the 1st Strategic Conference of the EFLM on “Defining analytical performance 15 years after the Stockholm Conference on Quality Specification in Laboratory Medicine”.

Results

A total of 76 clinical laboratories from 25 provinces in China continuously participated in this survey and submitted complete data for all QIs from 2015 to 2017. In general, the performance of all reported QIs have improved or at least kept stable over time. Defect percentages of blood culture contamination were the largest in the pre-analytical phase. Intra-laboratory TAT was always larger than pre-examination TAT. Percentage of tests covered by inter-laboratory comparison was relatively low than others in the intra-analytical phase. The performances of critical values notification and timely critical values notification were the best with 6.0σ. The median sigma level of incorrect laboratory reports varied from 5.5σ to 5.7σ.

Conclusions

QSs of QIs provide useful guidance for laboratories to improve testing quality. Laboratories should take continuous quality improvement measures in all phases of total testing process to ensure safe and effective tests.

Keywords: clinical laboratory; laboratory errors; quality indicators; quality specifications; total testing process

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About the article

aMin Duan and Xudong Ma contributed equally to this work. They are joint first authors.

bZhiguo Wang and Zongjiu Zhang contributed equally to this work. They are joint corresponding authors.


Received: 2018-04-21

Accepted: 2018-06-20

Published Online: 2018-07-17

Published in Print: 2018-12-19


Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.

Research funding: The organization of national survey on 15 QIs was supported by the National Health Commission of the People’s Republic of China, and the data management and statistics analysis was supported by the National Center for Clinical Laboratories. There was no funding source involved in this study.

Employment or leadership: None declared.

Honorarium: None declared.

Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.


Citation Information: Clinical Chemistry and Laboratory Medicine (CCLM), Volume 57, Issue 2, Pages 195–203, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: https://doi.org/10.1515/cclm-2018-0416.

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