Hitachi-high-technologies Corporation

Qing Li

Tomonori Mimura

Shinichi Fukuzono

Masaharu Nishida

Naomi Ishii

In a clinical laboratory, the degree of contamination of an automatic analyzer may constantly change due, for instance, to the operation of the automatic analyzer and newly added examinations, and there is a risk of failure to adequately maintain the performance of the automatic analyzer by performing calibration at conventional intervals. Meanwhile, the result of quality control varies depending on the performance of an unsealed reagent. Hence, performing calibration at predetermined intervals may fail to flexibly calibrate the reagent when the performance of the reagent is changed by reagent replenishment or by contamination. Provided is a quality control method for issuing a warning to indicate an optimum calibration method and calibration intervals in accordance with the contents of a quality control screen and with the pattern of variation in the result of calibration.

Quality control system

There is provided a comprehensive accuracy management method attained by including the steps of: displaying operation event information in time series in an accuracy management result chart or a calibration result chart on the same screen; accumulating a characteristic daily measurement value fluctuation pattern on the basis of a kind of an operation event; displaying the latest fluctuation pattern of measurement results and the daily measurement value fluctuation pattern in superposition with each other to warn of fluctuations which differ from the daily measurement value fluctuation pattern; and estimating and reporting the cause of the fluctuations.

Accuracy management method

Electrolyte analyzers are used in a variety of ways, and problems vary from reagent deterioration due to reagent replenishment, mixing of foreign substances during reagent replenishment, electrode deterioration due to the passage of the validity date, to the operator's inputting errors. It is thus necessary to judge abnormalities of measured values resulting from such inappropriate usage, based on the fluctuation patterns of the results of daily electrolyte calibration. The fluctuation patterns of each measured item are extracted from the results of daily electrolyte calibration. The electromotive force balance ratio between the internal standard solution and high/low-concentration standard solutions is calculated as well as its fluctuation pattern. The obtained fluctuation patterns are compared against atypical fluctuation patterns stored in the electrolyte analyzer. When any of the extracted patterns matches any of the atypical patterns, the analyzer activates an alarm.

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Hitachinaka, Japan

Qing Li