title: National continuous surveys on internal quality control for HbA1c in 306 clinical laboratories of China from 2012 to 2016: Continual improvement.
abstract: 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 (CVs) of HbA1c measurements were calculated. Finally, we comprehensively analyzed analytical systems and IQC practice of HbA1c measurements.
  
  
  RESULTS
  The current CVs of HbA1c tests have decreased significantly from 2012 to 2016. And percentages of laboratories meeting four imprecision specifications for CVs 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 CVs. The data of IQC practice, such as IQC rules and frequency, also showed significant variability among years with overall tendency of meeting requirements.
  
  
  CONCLUSIONS
  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.
authors.affiliation: National Center for Clinical Laboratories/Beijing Engineering Research Center of Laboratory Medicine, Beijing Hospital, National Center of Gerontology, Beijing, China.
authors.forename: Tingting
authors.initials: T
authors.lastname: Li
authors.affiliation: National Center for Clinical Laboratories/Beijing Engineering Research Center of Laboratory Medicine, Beijing Hospital, National Center of Gerontology, Beijing, China.
authors.forename: Wei
authors.initials: W
authors.lastname: Wang
authors.affiliation: National Center for Clinical Laboratories/Beijing Engineering Research Center of Laboratory Medicine, Beijing Hospital, National Center of Gerontology, Beijing, China.
authors.forename: Haijian
authors.initials: H
authors.lastname: Zhao
authors.affiliation: National Center for Clinical Laboratories/Beijing Engineering Research Center of Laboratory Medicine, Beijing Hospital, National Center of Gerontology, Beijing, China.
authors.forename: Falin
authors.initials: F
authors.lastname: He
authors.affiliation: National Center for Clinical Laboratories/Beijing Engineering Research Center of Laboratory Medicine, Beijing Hospital, National Center of Gerontology, Beijing, China.
authors.forename: Kun
authors.initials: K
authors.lastname: Zhong
authors.affiliation: National Center for Clinical Laboratories/Beijing Engineering Research Center of Laboratory Medicine, Beijing Hospital, National Center of Gerontology, Beijing, China.
authors.forename: Shuai
authors.initials: S
authors.lastname: Yuan
authors.affiliation: National Center for Clinical Laboratories/Beijing Engineering Research Center of Laboratory Medicine, Beijing Hospital, National Center of Gerontology, Beijing, China.
authors.forename: Zhiguo
authors.initials: Z
authors.lastname: Wang
mesh_terms: D001774:Blood Chemical Analysis / Q000379:methods / Q000592:standards*; D002681:China; D002851:Chromatography, High Pressure Liquid; D064790:Clinical Laboratory Services / Q000592:standards*; D006442:Glycated Hemoglobin / Q000032:analysis*; D006801:Humans; D000074024:Immunoturbidimetry; D011786:Quality Control; D015203:Reproducibility of Results
chemical_list: D006442:Glycated Hemoglobin
keywords: HbA1c; clinical laboratory; coefficient of variation; diabetes; diagnosis; imprecision; internal quality control; quality specification