External quality assessment of clinical laboratory quality indicators in China in 2015 / 中华检验医学杂志

ABSTRACT

Objective To investigate an evaluation program for external quality assessment ( EQA) of quality indicators ( QIs) and develop a software .Methods According to GB/T 27043-2012 ( ISO/IEC 17043:2010,IDT) mode 3, 28 provincial centers for clinical Laboratories were organized by National Center for Clinical Laboratories to launch an investigation on “QIs in clinical laboratory” with the use of Clinet-EQA online .Participants were asked to collect data of April 2014 and report related results online .Mean, median, the 5 th, 25 th, 75 th and 95 th percentiles of defectpercentages for biochemistry , immunology, blood and body fluid and microbiology were calculated , respectively .Sigma values were also calculated . Meanwhile , 25 th of sigma value and 75 th of defect percentages were chosen as preliminary quality specifications for each QI so that laboratories can evaluate related process quality .Results Take incorrect sample type rates for example , 4 771 laboratories were involved in this study .Among four subjects , incorrect sample type rates were lowest (0.01%, 6σ) for immunology tests, followed by blood and body fluids tests (0.06%, 4.7σ) and biochemistry tests (0.06%, 4.7σ), and were highest for microbiology tests (0.33%, 4.2σ).Evaluation reports will besent back to participants so that they can understand national , provincial , and their own sigma levels well .Preliminary quality specifications of incorrect sample type for biochemistry, immunology, blood and body fluid, and microbiology tests were 0.08% (4.6σ), 0.03%(5σ), 0.09%(4.6σ) and 0.43%(4.1σ), respectively.Conclusion Clinical laboratories were advised to establish and monitor suitable QIs within laboratory and participate in QIs EQA schemes , thus they can improve their quality continuously .