Results from 15 years of quality surveillance for a National Indigenous Point-of-Care Testing Program for diabetes

Introduction Diabetes is a major health problem for Australia's Aboriginal and Torres Strait Islander peoples. Point-of-care testing for haemoglobin A1c (HbA1c) has been the cornerstone of a long-standing program (QAAMS) to manage glycaemic control in Indigenous people with diabetes and recently, to diagnose diabetes. Methods The QAAMS quality management framework includes monthly testing of quality control (QC) and external quality assurance (EQA) samples. Key performance indicators of quality include imprecision (coefficient of variation [CV%]) and percentage acceptable results. This paper reports on the past 15 years of quality testing in QAAMS and examines the performance of HbA1c POC testing at the 6.5% cut-off recommended for diagnosis. Results The total number of HbA1c EQA results submitted from 2002 to 2016 was 29,093. The median imprecision for EQA testing by QAAMS device operators averaged 2.81% (SD 0.50; range 2.2 to 3.9%) from 2002 to 2016 and 2.44% (SD 0.22; range 2.2 to 2.9%) from 2009 to 2016. No significant difference was observed between the median imprecision achieved in QAAMS and by Australasian laboratories from 2002 to 2016 (p = 0.05; two-tailed paired t-test) and from 2009 to 2016 (p = 0.17; two-tailed paired t-test). For QC testing from 2009 to 2016, imprecision averaged 2.5% and 3.0% for the two levels of QC tested. Percentage acceptable results averaged 90% for QA testing from 2002 to 2016 and 96% for QC testing from 2009 to 2016. The DCA Vantage was able to measure a patient and an EQA sample with an HbA1c value close to 6.5% both accurately and precisely. Conclusion HbA1c POC testing in QAAMS has remained analytically sound, matched the quality achieved by Australasian laboratories and met profession-derived analytical goals for 15 years.