Open AccessNational continuous surveys on internal quality control for HbA1c in 306 clinical laboratories of China from 2012 to 2016: Continual improvement
Author(s) -
Li Tingting,
Wang Wei,
Zhao Haijian,
He Falin,
Zhong Kun,
Yuan Shuai,
Wang Zhiguo
Publication year - 2017
Publication title -
journal of clinical laboratory analysis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.536
H-Index - 50
eISSN - 1098-2825
pISSN - 0887-8013
DOI - 10.1002/jcla.22099
Subject(s) - external quality assessment , medical physics , clinical practice , quality (philosophy) , medicine , quality management , good laboratory practice , control (management) , computer science , quality assurance , operations management , family medicine , engineering , pathology , management system , philosophy , epistemology , artificial intelligence
Background This study aimed to evaluate whether the quality performance of clinical laboratories in China has been greatly improved and whether Internal Quality Control ( IQC ) practice of HbA1c has also been changed since National Center for Clinical Laboratories ( NCCL ) of China organized laboratories to report IQC data for HbA1c in 2012. Methods Internal Quality Control information of 306 External Quality Assessment ( EQA ) participant laboratories which kept reporting IQC data in February from 2012 to 2016 were collected by Web‐based EQA system. Then percentages of laboratories meeting four different imprecision specifications for current coefficient of variations ( CV s) of HbA1c measurements were calculated. Finally, we comprehensively analyzed analytical systems and IQC practice of HbA1c measurements. Results The current CV s of HbA1c tests have decreased significantly from 2012 to 2016. And percentages of laboratories meeting four imprecision specifications for CV s all showed the increasing tendency year by year. As for analytical system, 52.1% (159/306) laboratories changed their systems with the change in principle of assay. And many laboratories began to use cation exchange high‐performance liquid chromatography ( CE ‐ HPLC ) instead of Immunoturbidimetry, because CE ‐ HPLC owed a lower intra‐laboratory CV s. The data of IQC practice, such as IQC rules and frequency, also showed significant variability among years with overall tendency of meeting requirements. Conclusion The imprecision performance of HbA1c tests has been improved in these 5 years with the change in IQC practice, but it is still disappointing in China. Therefore, laboratories should actively find existing problems and take action to promote performance of HbA1c measurements.