Should quality goals be defined for multicenter laboratory testing? Lessons learned from a pilot survey on a national surveillance program for diabetes

International Journal for Quality in Health Care : Journal of the International Society for Quality in Health Care
Limin WangLinhong Wang

Abstract

Robust laboratory protocols and stringent quality control (QC) procedures are essential for meaningful collection of data from multiple sites in large-scale population-based studies. Failure to design and implement an effective QC program not only adversely affects the scientific outcome, but also affects public confidence in the acceptability of the data. A pilot survey was conducted to assess the analytical performance of multicenter plasma glucose measurements in a national surveillance program for diabetes in China. Quality goals of the imprecision in terms of coefficient of variation (CV) and total analytical error (TEa) were defined based on the Clinical Laboratory Improvement Amendments (CLIA) criteria for acceptable performance of proficiency testing (PT) for plasma glucose using commercial QC preparations. A web-based internal QC (IQC) program was established to monitor the analytical performance of the 302 centers participating in the survey. The participation rate was 96% (289/302). Statistical analysis showed that the percentage of centers meeting the acceptable specifications of CV ≤5.0% and TEa ≤10% using the CLIA PT criteria was 91.7% while 76.4% of laboratories achieved the goals for desirable performance of CV ...Continue Reading

References

Jul 1, 1990·Diabetic Medicine : a Journal of the British Diabetic Association·C G Fraser
Feb 10, 2000·Scandinavian Journal of Clinical and Laboratory Investigation·A KallnerC Heuck
Sep 5, 2013·JAMA : the Journal of the American Medical Association·Yu XuUNKNOWN 2010 China Noncommunicable Disease Surveillance Group
Oct 9, 2013·Bulletin of the World Health Organization·Yichong LiLinhong Wang
Oct 25, 2013·International Journal for Quality in Health Care : Journal of the International Society for Quality in Health Care·William A GhaliT Bedirhan Ustün
Apr 10, 2014·International Journal for Quality in Health Care : Journal of the International Society for Quality in Health Care·Agnès LeotsakosBill Munier
May 3, 2014·International Journal for Quality in Health Care : Journal of the International Society for Quality in Health Care·Maxine PowerLloyd Provost

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Citations

Oct 10, 2019·Revista brasileira de epidemiologia = Brazilian journal of epidemiology·Célia Landmann SzwarcwaldLuiz Gastão Rosenfeld

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