title: A new quality control method based on a moving average of "latent reference values" selected from patients' daily test results.
abstract: The average of normals(AON) method is a quality control(QC) method that uses measured values of patients' samples instead of QC samples. Because this method is easily affected by fluctuations in the patient population and is insensitive to short-term changes in test values, we developed an alternative method based on the moving average(MA) of latent reference values(LRVs) which are the test results of patients whose other related test results are all within reference intervals. We evaluate the new methodology(MALRV) using seven commonly measured biochemical tests. The LRV of each test were selected with reference to four other items that had the highest coincidences of abnormality. The optimum amount of data needed to compute the MA is determined as that making the coefficient of variation(CV) of the consecutive MA over a study period less than 5.0%. The MALRV is computed each time a new LRV is encountered to monitor quality status continuously. The MALRV CV was within 5.0% when sample sizes were between 20 and 110. When shift and trend simulations were performed with the patient data, the corresponding alterations were detected. MALRV is a useful measure for detecting short-term alterations in patient test results, supplementing the conventional QC chart method.
authors.affiliation: Laboratory for Clinical Investigation, Osaka University Hospital, Division of Biomedical Informatics, Osaka University, Graduate School of Medicine, Suita 565-0871.
authors.forename: Sadao
authors.initials: S
authors.lastname: Hayashi
authors.forename: Kiyoshi
authors.initials: K
authors.lastname: Ichihara
authors.forename: Yuzuru
authors.initials: Y
authors.lastname: Kanakura
authors.forename: Yoshinori
authors.initials: Y
authors.lastname: Iwatani
mesh_terms: D019411:Clinical Laboratory Techniques / Q000592:standards*; D006801:Humans; D011785:Quality Assurance, Health Care / Q000379:methods*; D011786:Quality Control; D012016:Reference Values; D018401:Sample Size; D013223:Statistics as Topic / Q000379:methods*