QA for Blood Chemical Analysis by ISO-GUM

Abstract

International Organization for Standardization (ISO) standard Quality Assurance (QA) is required for final report values in clinical Blood Chemical Analysis (BCA). In the medical field, an External Quality Assurance Scheme (EQAS) is required in order to make wide area medicine system useful and to prevent clinical mistakes stemming from ambiguous data. The fact that QA is based on statistical analysis for many years by Quality Engineering (QE) has been discussed. An improvement so that the ISO need not depend on statistical analysis for QA was proposed. Then ISO published a Guide of express Uncertainty inMeasurement (ISO-GUM) [1] in 1993. There are the two mainly changed parts at ISO-GUM. The first is changing evaluation of the ambiguous data into uncertainty from an error. The second is adding Exploratory Data Analysis (EDA) for the analysismethod to Analysis Of Variance (ANOVA) [2] in order to make abnormal distribution possible. ANOVA was only reported on the current situation of measurement result, while EDA came to be required in investigations of cause by ISO-GUM. This research is to help establish policies ensuring BCA result. This research results were used for information technology (IT) era in medical treatment in the European Union (EU) in 2010.