Automatic analysis device, management system, and management method

Abstract

In the present invention, when an instruction to mask analysis of a specific first analysis module 200, second analysis module 201, third analysis module 202, or fourth analysis module 203 among a plurality of analysis modules, namely, the first analysis module 200, the second analysis module 201, the third analysis module 202, and the fourth analysis modules 203 is received from an input / output unit 302, information about an analysis item the analysis of which becomes disabled in an automatic analysis device 100 due to the masking is extracted on the basis of analysis-related information transmitted respectively from the other analysis modules, namely, the first analysis module 200, the second analysis module 201, the third analysis module 202, or the fourth analysis module 203, and the input / output unit 302 is caused to output the information. With this configuration, the present invention provides an automatic analysis device, a management system, and a management method that make it possible to reduce analysis stop due to maintenance compared to the prior art.

Description

Automatic analyzer, management system, and management method

[0001] The present invention relates to an automatic analyzer, a management system, and a management method for analyzing biological samples such as blood and urine (hereinafter referred to as specimens).

[0002] As an example of an automatic analyzer that suppresses a decline in analytical efficiency, Patent Document 1 describes a device in which a control device determines for each sample whether there is a risk of abnormalities in the analysis results for multiple determination items, and based on the determination results, performs masking processing on the analysis units and analysis items related to the analysis of the sample, stores the determination items that caused the masking in a memory device, and displays the determination items that caused the masking on a display device.

[0003] JP 2013-140103 A

[0004] A pause (hereinafter referred to as a mask) function is known as one of the functions of automated analyzers used in clinical testing sites for qualitative and quantitative analysis of samples. This mask function temporarily stops the measurement of analysis items containing specific components (see Patent Document 1, etc., mentioned above).

[0005] Here, automated analyzers are sometimes required to operate 24 hours a day. When a user performs maintenance on an automated analyzer that operates 24 hours a day, depending on the type of maintenance, some of the two or more analytical units that make up the automated analyzer must be masked. However, not all analytical units can analyze all analysis items, and there is a possibility that some analysis items cannot be analyzed even though they are not masked when some analytical units are masked.

[0006] However, since maintenance is essential, measures must be taken to shorten the time that the apparatus is stopped due to the mask during maintenance.

[0007] In particular, large hospitals and testing centers often use automated analysis systems equipped with one or more automated analyzers, but these systems handle a large number of analysis requests and test items, and there is a strong demand for them to operate continuously for 24 hours. In such systems that operate 24 hours a day, it is highly desirable to minimize the time that analysis is interrupted due to masks.

[0008] The present invention provides an automatic analyzer, a management system, and a management method that can reduce the number of analysis stoppages due to maintenance compared to conventional methods.

[0009] The present invention includes multiple means for solving the above-mentioned problems. One example is an automatic analyzer comprising a plurality of sample analysis units that measure samples, and a control unit configured to be able to communicate with the plurality of sample analysis units, wherein the control unit has an input unit, an output unit, and an information processing unit, and when the information processing unit receives an instruction from the input unit to mask the analysis of a specific sample analysis unit among the plurality of sample analysis units, the information processing unit extracts analysis item information that will be rendered unanalyzable within the automatic analyzer due to the masking, based on analysis-related information transmitted from each of the other sample analysis units, and outputs the extracted analysis item information to the output unit.

[0010] According to the present invention, it is possible to reduce the number of analysis stoppages due to maintenance compared to the conventional art. Problems, configurations and effects other than those described above will become apparent from the following description of the embodiments.

[0011] 1 is a block diagram including an automatic analyzer and a management system according to an embodiment. FIG. 2 is a block diagram of a control system in the automatic analyzer according to an embodiment. FIG. 3 is a flowchart illustrating processing for displaying on a screen items that cannot be analyzed in the automatic analyzer according to an embodiment. FIG. 4 is an example of a screen displaying the mask status of a module in the automatic analyzer according to an embodiment. FIG. 5 is an example of a screen displaying items that cannot be analyzed due to the setting of a module mask in the automatic analyzer according to an embodiment. FIG. 6 is a flowchart illustrating processing for displaying on a screen items that cannot be analyzed between systems in the management system according to an embodiment. FIG. 7 is an example of a confirmation screen for receiving the status of other systems in the automatic analyzer according to an embodiment.

[0012] An embodiment of the automatic analyzer, management system, and management method of the present invention will be described with reference to Figures 1 to 7. In the drawings used in this specification, identical or corresponding components are designated by the same or similar reference numerals, and repeated description of these components may be omitted.

[0013] First, the overall configuration of the automatic analyzer and management system will be outlined with reference to Fig. 1. Fig. 1 is a block diagram including the automatic analyzer and management system of the embodiment.

[0014] The analysis system shown in Figure 1 includes two modular automatic analyzers 100, each of which includes a plurality of (four in this embodiment) first analysis modules 200, second analysis modules 201, third analysis modules 202, and fourth analysis modules 203 for measuring samples, and a control device 300 for controlling the overall operation of the plurality of first analysis modules 200, second analysis modules 201, third analysis modules 202, and fourth analysis modules 203.

[0015] The first analysis module 200, the second analysis module 201, the third analysis module 202, and the fourth analysis module 203 are each an analysis module configured to analyze nuclide analysis items such as biochemical items, immune items, electrolyte items, etc. The first analysis module 200, the second analysis module 201, the third analysis module 202, and the fourth analysis module 203 may be capable of analyzing the same analysis items or may be different, and are appropriately selected and determined depending on the user of the automated analyzer 100 or the analysis system.

[0016] The block diagram in FIG. 1 shows an example in which one automated analyzer 100 has a four-module configuration and two automated analyzers 100 are connected using a higher-level information system 401, i.e., an example of a multi-module automated analyzer having measurement units for multiple measurement types and an automated analysis system equipped with multiple such units. However, the device configuration is not limited to this, and there are no particular restrictions on the number of modules within the analyzer or the entire system, or the module configuration, as long as there are two or more analytical units in the target system. For example, a configuration may be provided in which two or more automated analyzers each have one analytical module. Furthermore, a transport module, a pre-processing module, and a post-processing module may be provided as necessary, and the configuration can be tailored to the user's needs.

[0017] The control device 300 is configured to be able to communicate with a plurality of first analysis modules 200, second analysis modules 201, third analysis modules 202, and fourth analysis modules 203, and is a device that controls the overall operation of the automated analyzer 100, including each device in these analysis modules, and is a computer or the like equipped with a CPU, memory, etc. This control device 300 is composed of an information processing unit (ARM) 301, an input / output unit 302, a storage unit (DB) 303, etc.

[0018] The information processing unit 301 is a part that controls the overall operation of the automatic analysis device 100, which includes multiple first analysis modules 200, second analysis modules 201, third analysis modules 202, and fourth analysis modules 203, and corresponds to the CPU mentioned above.

[0019] In this embodiment, the information processing unit 301 controls the display of screens that display various information such as information about the sample, information about the analysis items, and information about the analysis results on the display screen of the input / output unit 302. Furthermore, it controls the display of various screens related to the operation of the automated analyzer 100, such as an operation screen for starting the analysis, an analysis progress status, a screen for instructing the execution of maintenance, and information about the progress status of maintenance.

[0020] In particular, in this embodiment, when the information processing unit 301 receives an instruction from the input / output unit 302 to mask the analysis of a specific first analysis module 200, second analysis module 201, third analysis module 202, or fourth analysis module 203 among the multiple first analysis modules 200, second analysis module 201, third analysis module 202, or fourth analysis module 203, the information processing unit 301 extracts analysis item information that will become unanalyzable within the automated analysis device 100 due to the masking, based on the analysis-related information sent from each of the other first analysis modules 200, second analysis module 201, third analysis module 202, or fourth analysis module 203, and outputs the information to the input / output unit 302.

[0021] Furthermore, the information processing unit 301 can receive a plurality of pieces of analysis-related information, store them in the storage unit 303, and extract analysis item information based on the stored analysis-related information.

[0022] Furthermore, the information processing unit 301 causes the input / output unit 302 to display a selection area for confirming whether or not to perform masking, and performs masking when an instruction to perform masking is received via the input / output unit 302. For example, the information processing unit 301 causes the input / output unit 302 to display a masking confirmation screen 600 at a predetermined timing, which summarizes the masking status, whether or not masking is performed, stored in the storage unit 303, and the masking factors corresponding to each mask in the masking status.

[0023] Based on this premise, the information processing unit 301 of this embodiment has a mask function for temporarily suspending specific analysis items. This mask function is enabled or disabled depending on the status inside the device when, for example, maintenance is performed.

[0024] The masks described in this embodiment include manual masks, reagent masks, calibration masks, QC masks, inventory masks, and other masks.

[0025] In the present invention, the "predetermined timing" at which the mask confirmation screen 600 is displayed is when module masking is performed, but the timing is not particularly limited to this.

[0026] These will be described in detail later using the respective drawings.

[0027] The input / output unit 302 is composed of a display device such as a liquid crystal display that displays information such as an input screen for various parameters and settings, analytical test data for the initial test or retest, and measurement results, as well as information related to maintenance of the plurality of first analysis modules 200, second analysis module 201, third analysis module 202, and fourth analysis module 203, and a keyboard and mouse for inputting various data such as various parameters and settings, analysis request information, and instructions for starting analysis, etc. The input / output unit 302 may also be composed of a touch panel display device.

[0028] The storage unit 303 is a recording medium that records various types of information related to the automatic analyzer 100, and is configured, for example, with a hard disk drive, an SSD, or a non-volatile memory. In this embodiment, in particular, a plurality of pieces of analysis-related information are stored in the storage unit 303. This analysis-related information may include at least one of the operating statuses of the first analysis module 200, the second analysis module 201, the third analysis module 202, and the fourth analysis module 203, information on the reagents installed, maintenance implementation information, calibration implementation information, and quality control implementation information.

[0029] The above is the configuration of the automatic analyzer 100.

[0030] A functional block diagram of the automatic analyzer of the embodiment is shown in Fig. 2. Fig. 2 is a block diagram of a control system in the automatic analyzer of the embodiment.

[0031] 2, the information processing unit 301 incorporates a status management unit 301a, a calibration management unit 301b, a quality management unit 301c, a reagent management unit 301d, and a communication unit 301e, and based on user input received from the input / output unit 302, the communication unit 301e receives the input and acquires information from the storage unit 303. The data input to the storage unit 303 consists of, but is not limited to, status management information, calibration management information, quality control information, reagent management information, etc. When acquiring information from other automatic analyzers, a request is sent to the information system 401 and the data is received.

[0032] The control processing in the information processing unit 301 described in this specification is not limited to being executed by the information processing unit 301 in the control device 300 in the automatic analyzer 100, but can also be executed in an information system 401 (Laboratory Information System: LIS), which is a higher-level system of the automatic analyzer 100, or in a system used on the clinical side, such as an HIS (Hospital Information System), which is a system higher than the information system 401.

[0033] In other words, an information system 401 that manages an automated analysis system having two or more automated analysis devices 100 each having one or more first analysis modules 200, second analysis modules 201, third analysis modules 202, and fourth analysis modules 203 is configured to be able to communicate with multiple automated analysis devices 100, and when it receives an instruction to mask the analysis of a specific first analysis module 200, second analysis module 201, third analysis module 202, or fourth analysis module 203 among the first analysis modules 200, second analysis module 201, third analysis module 202, or fourth analysis module 203 of the multiple automated analysis devices 100, it is able to extract analysis item information that cannot be analyzed within the automated analysis system due to the masking based on analysis-related information sent from each of the first analysis modules 200, second analysis module 201, third analysis module 202, and fourth analysis module 203, including the other automated analysis devices 100, and output the extracted information to the input / output unit 302.

[0034] Next, the flow of each process related to the mask maintenance function in the automatic analyzer 100 according to this embodiment will be described with reference to Fig. 3. Fig. 3 is a flowchart showing the process related to the mask maintenance function for displaying on the screen items that cannot be analyzed in the automatic analyzer according to this embodiment.

[0035] Each step shown in FIG. 3 is executed by the information processing unit 301 of the control device 300.

[0036] As shown in Figure 3, first, when module masking is performed in response to a user instruction, the information processing unit 301 starts the masking process (step S901), and then collects from the memory unit 303 items that can be analyzed by the module (step S902), and also collects from the memory unit 303 items that can be analyzed by other modules connected to the same automatic analyzer 100 (step S903).

[0037] Next, the information processing unit 301 determines whether the items collected in step S902 can be supplemented with the items collected in step S903 (step S905). If it is determined that the items cannot be supplemented, the items are stored in the storage unit 303 (step S906). This check is performed for all analysis items to see if there are any items that cannot be analyzed (step S904).

[0038] Finally, after checking all the items collected in step S902, the information processing unit 301 outputs and displays the items that cannot be analyzed and that were stored in the storage unit 303 in step S906 to the input / output unit 302 (step S907).

[0039] FIG. 4 shows an example of a screen displaying the mask status of a module in the automatic analyzer of the embodiment, and FIG. 5 shows an example of a screen displaying items that cannot be analyzed due to the module mask being set.

[0040] The mask status screen 500 in FIG. 4 is a screen that is displayed on the input / output unit 302 by operating the input / output unit 302 when the user wants to check the mask status, and displays a module display area 501 and a mask status display area 502.

[0041] When it is recognized that a module mask is about to be performed and when it is confirmed that the mask status display area 502 has been pressed, the information processing unit 301 of the control device 300 collects the masking factors for the registered analysis items from the memory unit 303 and transitions to the mask confirmation screen 600 of Figure 5 or displays the mask confirmation screen 600 as a pop-up on the input / output unit 302.

[0042] The mask confirmation screen 600 shown in Fig. 5 displays a list of items that will become unable to be analyzed as a system if the automatic analyzer 100 is masked. In the form shown in Fig. 5, the mask confirmation screen 600 displays the mask status for each item in a table format, with a module name display column 601 (e801) and an analysis item name display column 602 ("xxx", "yyy", "zzz") displayed on the vertical axis.

[0043] The user looks at the module name display column 601 and analysis item name display column 602 on this mask confirmation screen 600, and after understanding the items that will no longer be able to be analyzed, if the user still wishes to perform the module mask operation, he or she presses the mask instruction area 603.

[0044] When it is recognized that the mask designation area 603 has been pressed, the corresponding mask is actually executed.

[0045] On the other hand, if the user wants to temporarily stop the mask and take some action, he or she presses the mask stop button 604 to stop the mask operation.

[0046] The factors that determine that analysis is not possible include the mask status of each item, such as a manual mask by the user, a calibration mask due to unperformed calibration, and a QC mask due to unperformed QC.

[0047] Next, a description will be given of a form in which processing is performed in the information system 401 or a form in which the status of other automatic analyzers 100 is confirmed via the information system 401, and a process flow for displaying items that cannot be analyzed between systems on the screen, with reference to Figures 6 and 7. Figure 6 is a flowchart illustrating a process for displaying items that cannot be analyzed between systems on the screen in the management system of the embodiment. Figure 7 is an example of a confirmation screen for receiving the status of other systems in the automatic analyzer of the embodiment.

[0048] Each step shown in FIG. 6 is executed by the information processing unit 301 or the information system 401.

[0049] 6, when a user instructs the information processing unit 301 to refer to another module, the information processing unit 301 acquires information about the other automatic analyzers 100 from the information system 401 (step S911). When the information system 401 executes the process, the information about the connected automatic analyzers 100 is acquired from each of the connected automatic analyzers 100.

[0050] Next, the information processing unit 301 or the information system 401 collects items that can be analyzed by the module from the memory unit 303 (step S912), and also collects items that can be analyzed by other connected modules from the memory unit 303 (step S913).

[0051] Next, the information processing unit 301 or the information system 401 determines whether the items collected in step S912 can be supplemented with the items collected in step S913 (step S915). If it is determined that the items cannot be supplemented, the items are stored in the storage unit 303 (step S916). All of the items collected in step S912 are checked.

[0052] Finally, the information processing unit 301 or the information system 401 outputs the items that cannot be analyzed, which were stored in the storage unit 303 in step S916, to the input / output unit 302 and displays them (step S917).

[0053] When the mask instruction area 603 on the mask confirmation screen 600 in FIG. 5 described above is pressed and another automatic analyzer 100 is connected or processing is being performed by the information system 401, the screen transitions from the mask status screen 500 in FIG. 4 or the mask confirmation screen 600 in FIG. 5 to the other device confirmation screen 700 in FIG. 7, or the other device confirmation screen 700 pops up.

[0054] 7, when the confirmation button 701 is pressed, the screen transitions to the mask confirmation screen 600 of the other system, and the status of the other automatic analyzer 100 is displayed in an integrated manner in the module name display column 601 and the analysis item name display column 602. In this case, when the mask instruction area 603 is pressed on the mask confirmation screen 600, the screen does not transition to the other device confirmation screen 700 of FIG. 7 or pop up, but rather executes mask processing.

[0055] On the other hand, if the user does not want to integrate the information with that of other automatic analyzers 100, or if the user wishes to continue the masking process without confirmation, the user presses the confirmation stop button 702 to continue the masking operation.

[0056] When attempting to display the status of other automatic analyzers 100 in an integrated manner, if the other automatic analyzers 100 are not running, for example, and are in a state where analysis cannot be performed, the analyzer 100 will determine that analysis is not possible.

[0057] Next, the effects of this embodiment will be described.

[0058] The automated analyzer 100 of this embodiment described above includes a plurality of first analysis modules 200, second analysis modules 201, third analysis modules 202, and fourth analysis modules 203 that measure samples, and a control device 300 configured to be able to communicate with the plurality of first analysis modules 200, second analysis modules 201, third analysis modules 202, and fourth analysis modules 203. The control device 300 has an input / output unit 302 and an information processing unit 301. The information processing unit 301 controls the plurality of first analysis modules 200, second analysis modules 201, third analysis modules 202, and fourth analysis modules 203 via the input / output unit 302. When an instruction to mask the analysis of a specific one of the first analysis module 200, the second analysis module 201, the third analysis module 202, and the fourth analysis module 203 is received, the automatic analyzer 100 extracts analysis item information that cannot be analyzed in the automatic analyzer 100 due to the masking, based on the analysis-related information transmitted from each of the other first analysis module 200, the second analysis module 201, the third analysis module 202, and the fourth analysis module 203, and outputs the extracted analysis item information to the input / output unit 302.

[0059] In this way, when an instruction is given to mask an analysis item of a specific analysis module, the items that can be analyzed within the device or system are aggregated, and the presence or absence of any analysis items that will become impossible to analyze within the system when the masking is performed is identified (for example, an analysis can only be performed by the first analysis module 200, so if the analysis is masked by the first analysis module 200, the analysis cannot continue; an analysis can be performed by both the first analysis module 200 and the second analysis module 201, but if it is masked by one, it cannot be handled by the other, etc.), and by providing this information, the user can see at a glance which items will no longer be able to be analyzed and whether it is okay to mask the module in question, which makes it possible to reduce analysis stoppages due to maintenance compared to before, leading to improved analysis efficiency compared to before.

[0060] Furthermore, by obtaining the status of other automatic analyzers 100 from the information system 401 and displaying it in an integrated manner, it is possible to perform masking processing that takes into account the entire examination room in which the automatic analyzer 100 is installed.

[0061] Furthermore, the analysis-related information includes at least one of the operating status of the first analysis module 200, the second analysis module 201, the third analysis module 202, and the fourth analysis module 203, information on the reagents installed, maintenance implementation information, calibration implementation information, and quality control implementation information, so that information on whether or not there are any modules that will be stopped by masks can be provided without omission.

[0062] Furthermore, the control device 300 further has a memory unit 303, and the information processing unit 301 receives multiple pieces of analysis-related information and stores them in the memory unit 303, and extracts analysis item information based on the stored analysis-related information, thereby making it possible to display the mask confirmation screen 600 more quickly than if information were collected manually after a mask instruction was given.

[0063] In addition, the information processing unit 301 displays a selection area on the input / output unit 302 to check whether or not to execute the mask, and executes the mask when instructed to do so via the input / output unit 302, thereby making it possible to respond according to the situation at hand, for example, when prioritizing analysis.

[0064] <Others> The present invention is not limited to the above-described embodiments, and various modifications and applications are possible. The above-described embodiments have been described in detail to clearly explain the present invention, and the present invention is not necessarily limited to those having all of the described configurations.

[0065] For example, although an example of creating a computer program to realize some or all of the above-mentioned configurations and functions has been described, some or all of them may also be realized in hardware, for example, by designing them as an integrated circuit.

[0066] DESCRIPTION OF SYMBOLS 100...Automated analyzer 200...First analysis module (sample analysis section) 201...Second analysis module (sample analysis section) 202...Third analysis module (sample analysis section) 203...Fourth analysis module (sample analysis section) 300...Control device 301...Information processing section 301a...Status management section 301b...Calibration management section 301c...Accuracy control section 301d...Reagent management section 301e...Communication section 302...Input / output section (input section, output section) 303...Memory section 401...Information system (management system) 500...Mask status screen 501...Module display area 502...Mask status display area 600...Mask confirmation screen 601...Module name display column 602...Analysis item name display column 603...Mask instruction area (selection area) 604...Mask stop button 700...Other device confirmation screen 701...Confirmation execution button 702...Confirmation stop button

Claims

1. An automatic analyzer comprising: a plurality of sample analysis units that measure samples; and a control unit configured to be able to communicate with the plurality of sample analysis units, wherein the control unit has an input unit, an output unit, and an information processing unit, and when the information processing unit receives from the input unit an instruction to mask the analysis of a specific sample analysis unit among the plurality of sample analysis units, it extracts analysis item information that will be rendered unanalyzable within the automatic analyzer due to the masking, based on analysis-related information transmitted from each of the other sample analysis units, and outputs the information to the output unit.

2. An automatic analyzer according to claim 1, wherein the analysis-related information includes at least one of the operating status of the sample analysis unit, information on the reagents installed, maintenance implementation information, calibration implementation information, and quality control implementation information.

3. An automatic analyzer according to claim 1, wherein the control unit further has a memory unit, and the information processing unit receives a plurality of pieces of analysis-related information, stores them in the memory unit, and extracts the analysis item information based on the stored analysis-related information.

4. An automatic analyzer according to claim 1, wherein the information processing unit causes the output unit to display a selection area for confirming whether or not to execute the mask, and executes the mask when instructed to execute the mask via the input unit.

5. A management system that manages an automatic analysis system equipped with two or more automatic analyzers each having one or more sample analysis units, configured to be able to communicate with a plurality of the automatic analyzers, and that, upon receiving an instruction to mask the analysis of a specific sample analysis unit among the sample analysis units of the plurality of automatic analyzers, extracts analysis item information that cannot be analyzed within the automatic analysis system due to the masking, based on analysis-related information transmitted from each of the other sample analysis units, and outputs the information to an output unit.

6. A method for managing an automatic analyzer having two or more sample analysis units, which, upon receiving an instruction to mask analysis by a specific sample analysis unit among the sample analysis units of a plurality of the automatic analyzers, extracts analysis item information that cannot be analyzed within the automatic analyzer due to the masking based on analysis-related information transmitted from each of the other sample analysis units, and outputs the extracted information to an output unit.

Images