JP2000266756A - Automatic analyzer - Google Patents

Abstract

(57) [Summary] [Problem] When a measured value of a quality control sample is out of a control range, a patient sample that needs re-measurement can be grasped.
Even in daily accuracy management, which is managed over time, it is possible to grasp the relationship between the state of the apparatus and the maintenance state that affect the analysis performance, the state of the reagent, and the measured value of the quality control sample. A sample number of a patient sample before and after measurement of a quality control sample is extracted by storing a sample measurement order, and control is performed so that information on the patient sample is output to a screen simultaneously with information on the quality control sample. In daily accuracy management,
The date and time when the maintenance was performed and the date and time when the reagent was replaced are stored, and the measured values of the quality control samples measured within the day are stored on the same screen in ascending order of the date and time. Can solve the problem.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to an automatic analyzer for analyzing a biological fluid sample of a patient, and in particular, to measure a quality control sample of a known concentration for confirming the performance of the device and the reagent, and to obtain the result. The present invention relates to an automatic analyzer capable of managing the information through a screen.

[0002]

2. Description of the Related Art Analytical examinations of patient samples for use in diagnosing diseases are often measured by automatic analyzers because a large number of biological samples are handled at the same time.

[0003] For this reason, it is particularly important to control the apparatus that performs the analysis, and it is necessary to determine whether the apparatus is operating normally and the measurement of the patient sample is being performed correctly, by checking the quality control sample of a known concentration between the patient sample measurements. Is measured and the value is managed.

[0004] Therefore, if the measured value of the quality control sample goes out of the control range, the cause is pursued, and it is determined which patient sample should be re-measured as well as returning to normal. It is important to process quickly.

On the other hand, the accuracy control of the conventional automatic analyzer only involves statistical processing of the reproducibility of the quality control sample measured a plurality of times and plots each measured value on a graph such as an X control chart.

In addition, two kinds of quality control samples are measured,
It has a function of plotting in real time on a bi-level diagram and notifying that the control range such as systematic error or accidental error is out of control range, but in any case, only the measured value of the quality control sample was managed. . On the other hand, in daily accuracy control for long-term management for the purpose of maintaining the performance of instruments and analytical reagents, statistical processing of reproducibility of quality control samples measured over multiple days and X-R control charts There is no function to display the maintenance status of the apparatus and the reagent state which affect the fluctuation of the measured value only by plotting on the graph.

[0007]

In the conventional automatic analyzer, whether the measured value of the quality control sample is within the control, outside the control, or the value measured a plurality of times has no variation or drift tendency, or It has many built-in functions to determine whether there is a tendency to shift.

[0008] However, the information that the user wants is, in addition to the above, especially when the measured value of the quality control sample is out of control, not only to identify the cause of the abnormality, but also more important. Is to identify patient samples that were not accurately measured due to the cause, and re-measure them immediately.

[0009] However, the conventional automatic analyzer did not have a function of outputting information for this purpose.

Therefore, when the measured value of the quality control sample goes out of control, the user searches for a print location of the measurement result of the quality control sample out of control from the huge amount of printed results, and from there, searches for the last control. Patient samples measured up to the measurement results of the quality control samples that had been within and those that were measured after out of control had to be found.

However, even with this means, from the viewpoint of quick report of the results, the function of outputting the result of the sample of only the electrolyte item or the result of the sample of the analysis item having a short reaction time in preference to the result of the other sample, etc. In some cases, the result was printed out of the order of analysis, and it was very difficult to make an accurate judgment.

[0012] On the other hand, the daily difference accuracy management manages the state of the apparatus and reagents according to the fluctuation of data over time, such as trends and shifts, even if the measured values are not out of control. In this regard, in the conventional automatic analyzer as well, the quality control screen, the reagent information screen, and the maintenance status screen are independent of each other.

Therefore, in order to grasp the relevance,
Copy each screen and print it out on the printer and check it against each other, or prepare a separate measurement diary to enter and manage the reagent replacement and maintenance status of the equipment, and save a lot of time and effort. Needed.

An object of the present invention is to search for a patient sample requiring reconfirmation or remeasurement from a measured value of a quality control sample,
An object of the present invention is to reduce the trouble of searching by notifying an operator of the information through a screen.

Another object of the present invention is to provide information necessary for maintaining performance by simultaneously outputting a maintenance state and a reagent state which influence fluctuations of measured values of a quality control sample in daily accuracy control. It is in.

[0016]

The intra-day quality control of the automatic analyzer to which the present invention is applied is provided with a storage unit for storing the sample measurement order and the sample number of the patient sample between the quality control sample measurements. When the measured value of the sample is out of the control, a control unit that outputs information of the patient sample together with the measured value is provided.

Here, the information on the patient sample includes the patient sample number after the measurement of the quality control sample that was within the control, the patient sample number before the measurement of the quality control sample that was determined to be out of control, and the patient sample number that was determined to be out of control. It is the patient sample number measured after the measured quality control sample, and the measurement result of the designated patient sample number.

On the other hand, in the daily accuracy management, a storage unit for storing maintenance date and time of replacement of equipment parts and cleaning of the apparatus and replacement date and time of reagents input on the screen and a daily accuracy control sample value are stored. A storage unit for storing the date and time accumulated in the control is provided.The date and time when the maintenance was performed, the date and time when the maintenance was performed, and the date and time when the reagent was replaced were displayed on the same screen as the measured value of the quality control sample on the daily accuracy control chart. It is characterized by including a control unit for displaying simultaneously.

[0019]

FIG. 1 shows a schematic configuration of an automatic biochemical analyzer to which the present invention is applied.

The present apparatus comprises a sample disk 2 for moving a sample cup 1 containing a plurality of patient samples and a quality control sample one by one to a sample suction position, and a sample dispensing mechanism for dispensing a sample. 3. Reagent dispensing mechanisms 4a and 4b for dispensing reagents according to analysis items and analysis reagents 5
reagent disks 6a and 6b in which a and 5b are arranged, a reaction disk 8 in which a plurality of permeable reaction vessels 7 are arranged in a ring and functioning as a reaction line, stirring mechanisms 9a and 9b for stirring a reaction solution in the reaction vessels, The apparatus includes a light source 10 for measuring the absorbance of a reaction solution in a reaction vessel arranged on the line, a multi-wavelength photometer 11, and a washing mechanism 12 for washing the reaction vessel arranged along the reaction disk 8. Also, an operation panel 13 for instructing the measurement, a central processing unit 14 for controlling the entire mechanism and converting the measured absorbance into a concentration or an enzyme activity value, a printer 15 for printing the measurement results, and a CRT screen 16 for displaying the results. And a hard disk 17 for storing measurement results.

The operation of storing the measurement order according to the present invention using such an automatic analyzer will be described with reference to the flowchart of FIG.

First, when the power of the apparatus is turned on in S1, S
At 2, the patient sample number (S.No.) and the quality control sample number (C.No.) are each reset to 1, and at S3, the number (P) for managing the measurement order is reset to 1.

Next, when the start of analysis is instructed by the user in S4, it is first determined in S5 whether or not a request for measurement of a quality control sample has been made. If so, dispensing of the quality control sample is performed in S6. Done. Next, in S7, the number of the quality control sample corresponding to the number for managing the measurement order is stored in the hard disk of the storage unit, and in S8, the measurement order control number and the number of the quality control sample are incremented by one. .

Next, in step S9, it is determined whether or not the measurement of the patient sample is requested. If the request is made, the patient sample is dispensed in step S10, and then in step S11, the patient corresponding to the number for managing the measurement order is determined. The sample number is stored.

In step S12, the measurement order control number and the quality control sample number are incremented by one. Thereafter, in S13, the apparatus determines whether or not there is a request for measurement of a quality control sample or a patient sample, or instructs the user by the user. If there is a request, the steps from S5 to S12 are repeated. If there is no request, S14
Ends the analysis operation.

As described above, in the storage unit for storing the measurement order, as shown in FIG. 3, the number of the quality control sample and the patient sample number are stored for the measurement order number. It becomes easy to search for a patient sample number.

Next, the processing operation when the measurement result of the quality control sample is determined to be out of control will be described with reference to the flowchart of FIG.

At S21, the measured value of the quality control sample is output. If the value is determined to be out of control at S22, the process proceeds to S23.
Then, the measurement order number of the quality control sample is confirmed, then the measurement order number of the quality control sample measured last time is searched in S24, and the patient number measured during that time is extracted in S25.

In the example of FIG. 3, if the quality control sample of the measurement order number 13 is determined to be out of control and the other samples are within control, the patient sample number extracted by the above method is S
a6 to Sa10. If there is a patient sample already dispensed after the quality control sample determined to be out of control, the process proceeds to S27 after the determination in S26, and proceeds to S28.
Then, the patient sample number is extracted.

In the example of FIG. 3, the patient sample numbers to be extracted are Sa11 to Sa13.

The patient sample number extracted in the above steps is displayed on the same screen as shown in the example of FIG. 5 with the display of the measured value of the quality control sample on the CRT screen 16 in S29. (S30). If the measured value of the quality control sample is within the control, only the measured value of the quality control sample is displayed in S30, and the process ends (S31).

Thus, the operator can immediately recognize the patient sample to be re-measured.

Next, in the daily accuracy management, the items of the maintenance contents instructed by the operator from the screen and the date and time when the maintenance was performed or the items and the date and time when the reagent was replaced are stored.
Further, the date and time when the measured value of the quality control sample measured within the day is accumulated in the day difference is stored and displayed on the same screen in ascending date and time as shown in the example of FIG. This makes it easy to grasp the relationship between the device status or the state of the reagent and the measured value of the quality control sample.

[0034]

According to the present invention, when the measured value of the quality control sample goes out of the control range, the patient sample which needs to be re-measured can be immediately grasped.

In the daily accuracy control, which is managed over time, the state of the apparatus and the maintenance state and the state of the reagent which affect the analytical performance are displayed together with the measured values of the quality control sample. Can be clarified, and data can be easily maintained.

[Brief description of the drawings]

FIG. 1 is a diagram showing a schematic configuration of an automatic biochemical analyzer to which the present invention is applied.

FIG. 2 is a flowchart example of storing a measurement order.

FIG. 3 is a diagram for explaining the contents of a storage unit.

FIG. 4 is a flowchart example of a process for display.

FIG. 5 is a diagram showing a display example of intraday accuracy management.

FIG. 6 is a diagram showing a display example of daily difference accuracy management.

[Explanation of symbols]

DESCRIPTION OF SYMBOLS 1 ... Sample cup, 2 ... Sample disk, 3 ... Sample dispensing mechanism, 4a, 4b ... Reagent dispensing mechanism, 5a, 5b
... Analytical reagent, 6a, 6b ... Reagent disk, 7 ... Reaction container, 8 ... Reaction disk, 9a, 9b ... Stirring mechanism, 10 ...
Light source, 11: Multi-wavelength photometer, 12: Cleaning mechanism, 13: Operation panel, 14: Central processing unit, 15: Printer, 16
... CRT screen, 17 ... Hard disk.

 ──────────────────────────────────────────────────の Continuing on the front page (72) Inventor Mitsuo Hattori 1040 Ichimo Ichimo, Hitachinaka City, Ibaraki Prefecture Inside Hitachi Science Systems Co., Ltd. 2G058 BB05 BB07 CB05 CD04 CE08 EA02 EA04 EA14 ED03 FA02 GA02 GC00 GD05

Claims (2)

[Claims] 1. A reaction section having a plurality of reaction vessels, a sample supply section for supplying a sample to the reaction vessel, a reagent supply section for supplying a reagent according to an analysis item, and a measurement for measuring a generated reactant. An automatic analyzer for measuring a patient sample and measuring a quality control sample of a known concentration, comprising a storage unit for storing a sample measurement order and a sample number of the patient sample before and after the quality control sample measurement. An automatic analyzer comprising: a control unit for outputting information on a patient sample simultaneously with information on a quality control sample. 2. The automatic analyzer according to claim 1, wherein the information stored in the storage unit and the information output from the control unit are a maintenance time such as replacement of the device parts and a device cleaning and a replacement time of the reagent. Automatic analyzer.