title: The Nanjing Glycated Hemoglobin Standardization Program: 2012 to 2015.
abstract: This study aims to investigate glycosylated hemoglobin (HbA1c), between-laboratory imprecision (%CV), and pass rates from 2012 to 2015 in Nanjing to provide evidence for improving the HbA1cmeasurement.
  
  
  
  This was a retrospective, descriptive analysis of HbA1clevels obtained from participating hospitals in Nanjing from 2012 to 2015. The HbA1clevels of fresh whole blood samples taken from healthy and diabetic adults were determined within 24 hours. HbA1clevels (low level: 4.0%-6.0% HbA1c; medium level: 6.1%-8.0% HbA1c; and high level: 8.1%-10.0%) were grouped. Meanwhile, the target values were determined and assigned by a Level I-certified laboratory to assess the accuracy. Results as %HbA1cand related detection information, such as methods, were collected from all participants, then evaluated after each survey part of the program.
  
  
  
  Overall, the %CVs acquired by HPLC methods were lower than those determined by other methods. Pass rates ranged from 62.9% to 100%, depending on the HbA1clevel, and overall pass rates increased from 54.3% to 94.4% for those laboratories passing the 3 HbA1clevels. In addition, the top-grade hospital-based laboratories had better performances than the secondary hospital-based laboratories in 2012 to 2015.
  
  
  
  The use of accuracy-based proficiency testing with stringent quality-control management has greatly improved the performance of HbA1ctesting. The Nanjing Glycated Hemoglobin Standardization Program (NJGHSP) played an important role in this improvement by encouraging use of more rigorous quality control, participation in external proficiency testing programs, and providing education.
authors.affiliation: Department of Laboratory Medicine, the Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing University, Nanjing, PR China. Electronic address: 13505151066@163.com.
authors.forename: Kui
authors.initials: K
authors.lastname: Zhang
authors.affiliation: Department of Clinical Laboratory, Changzhou No. 2 People's Hospital affiliated to Nanjing Medical University, Changzhou, PR China.
authors.forename: Yan
authors.initials: Y
authors.lastname: Wang
authors.affiliation: Department of Laboratory Medicine, the Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing University, Nanjing, PR China.
authors.forename: Hongxia
authors.initials: H
authors.lastname: Wei
authors.affiliation: Department of Laboratory Medicine, the Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing University, Nanjing, PR China.
authors.forename: Zhiye
authors.initials: Z
authors.lastname: Xu
mesh_terms: D000328:Adult; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D003920:Diabetes Mellitus / Q000097:blood*; D006442:Glycated Hemoglobin / Q000032:analysis*; D006761:Hospitals; D006801:Humans; D007753:Laboratories; D011786:Quality Control; D012189:Retrospective Studies
chemical_list: D006442:Glycated Hemoglobin
keywords: EQA; between-laboratory imprecision; glycated hemoglobin; proficiency testing; quality control; standardization