Quality control system

• US 20070217949A1
• Filed: 02/26/2007
• Published: 09/20/2007
• Est. Priority Date: 03/14/2006
• Status: Active Grant

• Current Assignee: Hitachi High-Tech Company Limited (Hitachi, Ltd.)
• Original Assignee: Hitachi High-Technologies Corporation (Hitachi, Ltd.)
• Inventors: Mimura, Tomonori, Kawase, Kazumitsu
• Granted Patent: US 8,524,153 B2
• Time in Patent Office: Days
• US Class Current: 422/63
• CPC Class Codes: G01N 35/00603 Reinspection of samples
• CPC Class Codes: G01N 35/00613 Quality control
• CPC Class Codes: G01N 35/00712 Automatic status testing, e.g. at start-up or periodic
• CPC Class Codes: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: Y10T 436/11 Automated chemical analysis
• CPC Class Codes: Y10T 436/113332 with conveyance of sample along a test line in a container or rack
• CPC Class Codes: Y10T 436/115831 Condition or time responsive
• CPC Class Codes: Y10T 436/2575 Volumetric liquid transfer

Abstract

In a clinical laboratory of a hospital, an enormous amount of effort has been required to maintain the quality of an analyzer, standard solution and control samples. An object of the present invention is to provide a control method for controlling a clinical laboratory with reduced cost, and a control apparatus using the same.

In order to control data of an analyzer, standard solution, and a control sample, a support center is connected to each analyzer located in each hospital through a network line. Various kinds of analysis parameters and the result of measurements are exchanged so as to provide each clinical laboratory with a control situation in real time.

Claims

1. A quality control system comprising:

a facility that includes an automated analyzer for mixing a reagent with a sample to analyze a target component contained in the sample;

collection means for collecting, on a facility basis, information about analysis parameters including a standard solution lot number of a standard solution used for calibration and a standard solution lot number of a standard solution used for quality control, and information about results of measuring the standard solution used for quality control and results of measuring the standard solution used for calibration, through a communication line;

database storing means for storing, on a facility basis, the information collected by the collection means; and

statistical-processing calculation means for performing statistical processing of results of calibration performed by an analyzer of each facility to calculate results of the statistical processing, based on the information stored in the database storing means on a facility basis, the information including the information about the analysis parameters including the standard solution lot number of the standard solution used for calibration and the standard solution lot number of the standard solution used for quality control, and the information about the results of measuring the standard solution used for quality control and the results of measuring the standard solution used for calibration.

2. The quality control system according to claim 1, wherein:

a support center including the statistical-processing calculation means includes means for reporting the calculation results obtained by the statistical-processing to each facility.

3. The quality control system according to claim 2, further comprising

means for using the statistical-processing calculation means to calculate, on a facility basis, upper and lower limits for the measurement sensitivity and the blank absorbance of a reagent, the measurement sensitivity and the blank absorbance being measured on a daily basis and on an item basis, and for transmitting, if the calibration results of each analyzer goes out of a range between the upper and lower limits, information to each facility through a network line.

4. The quality control system according to claim 2, further comprising

means for simultaneously displaying, on an item basis, control values of the calibration having been subjected to the statistical processing in the support center and the result of measuring a quality control sample on a screen of the automated analyzer of each of the facilities.

5. The quality control system according to claim 4, further comprising

means for identifying and displaying, if the standard solution lot or the reagent lot is changed, the changed lot on the screen.

6. The quality control system according to claim 1, wherein:

as the result of calibration, a dominant wavelength and a secondary wavelength with respect to the blank absorbance of the reagent are separately displayed.

7. The quality control system according to claim 1, further comprising

means for changing, on an item basis, a displayed color for calibration for each reagent bottle.

8. The quality control system according to claim 1, further comprising

means for, if the same reagent lot and the same standard solution lot are used, calculating a standard deviation and an average value from absorbance data that has been collected as a result of performing measurement ten times or more in the past, and then storing the standard deviation and the average value as control coefficients, the calculation being performed for each calibration.

9. The quality control system according to claim 2, further comprising

means for calculating an allowable value of a K factor from results of calibration performed a plurality of times, and for, if the allowable value exceeds ±

2 SD, issuing an alarm through a network line.

10. The quality control system according to claim 7, further comprising:

storing means for storing, on an item basis, a pattern of change with time of the absorbance for each reagent bottle; and

means for making a comparison with the pattern on a bottle basis, and for, if there is a difference from the pattern of change with time, issuing an alarm for an abnormal condition through the network line.

11. The quality control system according to claim 1, further comprising means for displaying, on a screen, information together with quality control data of control samples,

wherein quality control data, and the calibration result, of a plurality of other facilities are displayed.

12. The quality control system according to claim 10, further comprising

means for extracting, on an item basis, the result of measuring the same control sample lot and the same standard solution from a plurality of facilities so that the measurement result is subjected to statistical processing, and for displaying quality control data, and distribution information including average and deviation values of the calibration result.

13. The quality control system according to claim 8, further comprising

means for, if the same reagent lot and the same standard solution lot are used, calculating uncertainty obtained from calibration data that has been collected as a result of performing calibration ten times or more in the past.