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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

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Volume 57, Issue 6


A pilot study for establishing quality indicators in molecular diagnostics according to the IFCC WG-LEPS initiative: preliminary findings in China

Rui Zhou
  • Department of Clinical Laboratory, Beijing Chaoyang Hospital, The Third Clinical Medical College of Capital Medical University, Beijing, P.R. China
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Yali Wei
  • Department of Clinical Laboratory, Beijing Chaoyang Hospital, The Third Clinical Medical College of Capital Medical University, Beijing, P.R. China
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Laura Sciacovelli / Mario Plebani / Qingtao Wang
  • Corresponding author
  • Department of Clinical Laboratory, Beijing Chaoyang Hospital, The Third Clinical Medical College of Capital Medical University, Beijing, P.R. China
  • Email
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
Published Online: 2018-12-14 | DOI: https://doi.org/10.1515/cclm-2018-0966



Quality indicators (QIs) are crucial tools in measuring the quality of laboratory services. Based on the general QIs of the Working Group “Laboratory Errors and Patient Safety (WG-LEPS)” of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC), specific QIs have been established in order to monitor and improve the quality of molecular diagnostics, and to assess the detection level of associated disease.


A survey was conducted on 46 independent commercial laboratories in China, investigated using questionnaires and on-site inspections. Specific QIs established were mainly based on the specific laboratory work-flow for molecular diagnoses. The specific QI results from three volunteer laboratories were collected and used to validate their effectiveness.


Of the 46 laboratories participating in the study, 44 (95.7%), conducted molecular diagnostics. Of 13 specific established QIs, six were priority level 1, and seven, priority level 3. At pre-evaluation of data from the three volunteering laboratories, it was found that the newly classified specific QIs had outstanding advantages in error identification and risk reduction.


Novel specific QIs, a promising tool for monitoring and improving upon the total testing process in molecular diagnostics, can effectively contribute to ensuring patient safety.

Keywords: error; molecular diagnostics; quality improvement; quality indicators; total testing process


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About the article

Corresponding authors: Prof. Mario Plebani, Department of Laboratory Medicine, Padova University Hospital, Via Giustinani 2, 35128 Padova, Italy; and Prof. Qingtao Wang, Department of Clinical Laboratory, Beijing Chaoyang Hospital, The Third Clinical Medical College of Capital Medical University, No.8 Gongti South Street, Chaoyang District, Beijing, P.R. China

aRui Zhou and Yali Wei contributed equally to this work.

Received: 2018-09-01

Accepted: 2018-10-29

Published Online: 2018-12-14

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: Investigation on the quality control and the study on countermeasures of continuous improvement of municipal hospitals: the Beijing Municipal Administration of Hospitals. The establishment and evaluation on the standardization method of point-of care HbA1c testing and on the method of HbA1c molecular typing by mass spectrometry at different level laboratories: the National Clinical Key Specialty Construction P. The establishment of reference measurement system based on ID-LC/MS for glycated albumin and research about application in diagnosis of DM: the National Natural Science Foundation of China.

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 822–831, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: https://doi.org/10.1515/cclm-2018-0966.

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