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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
ISSN
1437-4331
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Volume 57, Issue 6

Issues

Analysis and evaluation of the external quality assessment results of quality indicators in laboratory medicine all over China from 2015 to 2018

Min Duan
  • National Center for Clinical Laboratories/Beijing Engineering Research Center of Laboratory Medicine, Beijing Hospital, National Center of Gerontology, Dongcheng District, 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:
  • De Gruyter OnlineGoogle Scholar
/ Fengfeng Kang
  • Zhejiang Center for Clinical Laboratories, Zhejiang Provincial People’s Hospital, Zhejiang, P.R. China
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Haijian Zhao
  • National Center for Clinical Laboratories/Beijing Engineering Research Center of Laboratory Medicine, Beijing Hospital, National Center of Gerontology, Dongcheng District, Beijing, P.R. China
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Wei Wang
  • National Center for Clinical Laboratories/Beijing Engineering Research Center of Laboratory Medicine, Beijing Hospital, National Center of Gerontology, Dongcheng District, Beijing, P.R. China
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Yuxuan Du
  • National Center for Clinical Laboratories/Beijing Engineering Research Center of Laboratory Medicine, Beijing Hospital, National Center of Gerontology, Dongcheng District, Beijing, P.R. China
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Falin He
  • National Center for Clinical Laboratories/Beijing Engineering Research Center of Laboratory Medicine, Beijing Hospital, National Center of Gerontology, Dongcheng District, Beijing, P.R. China
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Kun Zhong
  • National Center for Clinical Laboratories/Beijing Engineering Research Center of Laboratory Medicine, Beijing Hospital, National Center of Gerontology, Dongcheng District, Beijing, P.R. China
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Shuai Yuan
  • National Center for Clinical Laboratories/Beijing Engineering Research Center of Laboratory Medicine, Beijing Hospital, National Center of Gerontology, Dongcheng District, Beijing, P.R. China
  • Other articles by this author:
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/ Bingquan Chen / Zhiguo Wang
  • Corresponding author
  • Graduate School of Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, P.R. China
  • 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, Phone: +86-010-58115054, Fax: +86-010-65273025
  • Email
  • Other articles by this author:
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Published Online: 2018-12-04 | DOI: https://doi.org/10.1515/cclm-2018-0983

Abstract

Background

This study aimed to comprehensively evaluate laboratory quality in China and explore factors affecting laboratory errors through analyzing the external quality assessment (EQA) results of quality indicators (QIs).

Methods

According to model 3 (interpretive) of the proficiency testing scheme, the National Center for Clinical Laboratories of China (CNCCL) developed a questionnaire for 15 QIs. Clinical laboratories from different provinces of China participated in the EQA program of QIs annually and submitted data via an online reporting system named Clinet-EQA. The results of QIs were expressed in percentage and sigma value or minute. Three levels of quality specifications (QSs) were defined based on percentile values. Furthermore, the QIs were analyzed by disciplines, hospital scales and information construction levels of participant laboratories.

Results

A total of 3450 laboratories nationwide continuously attended the EQA program and submitted complete data from 2015 to 2018. The performance of most QIs has improved year by year. QIs in post-analytical gained the best performance with sigma values that varied from 5.3σ to 6.0σ. The comparison of results among different disciplines showed significant differences for five QIs. More than half of QIs had statistical differences among different hospital scales measured by hospital grades and number of hospital beds. The performance of nine QIs were influenced by information construction levels of participant laboratories.

Conclusions

The overall laboratory quality in China has improved since the initiation of EQA program for QIs, but the performance of some QIs was still unsatisfactory. Therefore, laboratories should make efforts for continuous quality improvement based on information provided by QSs.

This article offers supplementary material which is provided at the end of the article.

Keywords: external quality assessment; laboratory errors; laboratory medicine; quality indicators; quality specifications

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About the article

Received: 2018-09-06

Accepted: 2018-11-13

Published Online: 2018-12-04

Published in Print: 2019-05-27


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

Research funding: National Natural Science Foundation of China in 2018 (81871737).

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 6, Pages 812–821, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: https://doi.org/10.1515/cclm-2018-0983.

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