QA for Blood Chemical Analysis by ISO-GUM
Chaos Applied Research Office, The Society of Instrument and Control Engineers, Kansai Chapter, 4-55 Otabicho kuga Fushimuku, Kyoto 612-8493, Japan
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)  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)  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.
-  BIPM. IEC. IFCC. ISO. IUPAC. OIML, “Guide to the Expression of Uncertainty in measurement,” in 1993, revised and corrected 2nd, pp. 188-189, 1995, ISBN 92-67-10.
-  ENGINEERING STATISTICS HANDBOOK issue NISTNIST/SEMATECH, issue NIST in 1992.
-  P. Fotowics, “Method for calculating the coverage factor in calibration,” OIML Bulletin XLIII, No.4, October, 2002.
-  U. M. Koczynsky, “CALCULATION OF EXPANDED UNCERTAINTY,” IMEKO in 2000.
-  B. N. Taylor and C. E. Kuyatt, “Guideline for Evaluating and Expressing the Uncertainty of NISTMeasurement result,” NIST Technical report Note 1297 in 1994 edition.
-  J. M. Korczyski, “CALCULATION OF EXPANDED UNCERTAINTY,” Joint IMEKO TC-1 & XXXIV MKM Conf. 2002, Wroclaw 8-12, September, 2002.
-  G. Fanti, “A POSSIBLE IMPROVEMENT TO THE ISO-GUM,” IMEKO-2000 WORLD CONGRESS, Vol.9, pp. 77-82, in AUSTRRIA, 2000.
-  Rodbad and D. M. Hutt, “STATISTICAL ANALYSIS OF IMMUNORAIOMETORY,” LABELLD ANTIBODY ASSAY, IAEA SM-!77/278, 1977.