Quality control system

Patent metadata

Field	Value
Publication number	US-9483441-B2
Application number	US-201113809956-A
Country	US
Kind code	B2
Filing date	Jun 30, 2011
Priority date	Jul 22, 2010
Publication date	Nov 1, 2016
Grant date	Nov 1, 2016

Abstract

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.

First claim

The invention claimed is:

1. An automatic analyzer, comprising:
a sample cup having a barcode attached thereto and holding a quality control substance;
a sample barcode reader configured to read the barcode attached to the sample cup;
a multi-wavelength photometer configured to measure a solution containing the quality control substance;
a display; and
a control unit connected to the sample barcode reader, the multi-wavelength photometer, and the display,
wherein the control unit is programmed to:
identify a lot number and vial number of the quality control substance based on information read by the barcode reader,
display a measurement result in a low-concentration region of the quality control substance on the display,
display a measurement result in a high-concentration region of the quality control substance on the display,
calculate a variation pattern of at least one of the measurement in the low-concentration region and the high-concentration region of the quality control substance and display the variation pattern on the display,
store the calculated variation patterns based on a time of calculation,
display a selection screen on the display enabling selection of a time period to display the measurement result in the low-concentration region, the measurement result in the low-concentration region, and the variation pattern, and enabling selection of a time frame from which the calculation of the variation pattern is calculated,
calculate an optimum calibration interval and method based on the stored calculated variation patterns
display the calculated optimum calibration interval and method on the display screen.

2. The automatic analyzer of claim 1 ,
wherein, the control unit is further programmed to determine whether the stored variation patterns periodically drift together with an S 1 Abs and a K factor, and if the stored variation patterns drift, a two-point calibration is determined to be optimum calibration method at shortened intervals.

3. The automatic analyzer of claim 1 ,
wherein the display of the measurement result in the low-concentration region of the quality control substance, the display a measurement result in the high-concentration region of the quality control substance and the variation pattern are displayed simultaneously during the time period.

Assignees

• Li Qing
• Nishida Masaharu
• Hitachi High Tech Corp

Inventors

• Li Qing
• Nishida Masaharu

Classifications

• G01N35/00613

  Quality control · CPC title

• G01N35/00693

  Calibration · CPC title

• G01N35/00712 Primary

  Automatic status testing, e.g. at start-up or periodic · CPC title

• G06F17/00 Primary

  Digital computing or data processing equipment or methods, specially adapted for specific functions (information retrieval, database structures or file system structures therefor G06F16/00) · CPC title