Analysis system, server device, control method and recording medium

Abstract

The analysis system of the present invention comprises: an analysis device (200) for analyzing a sample managed by an analysis center (1200); and a server device (100) managed by a service center (1100). The server device (100) associates and stores a first reference sample ID for identifying a first reference sample with a first range based on the first reference value, the analysis device (200) analyzes the provided first reference sample without being informed of the first reference value, and sends the first reference sample ID and the analysis value of the first reference sample associated with the first reference sample ID to the server device (100). When the server device (100) determines that the analysis value of the received first reference sample does not belong to the first range corresponding to the received first reference sample ID, it outputs an abnormal signal.

Description

Technical Field

[0001] The present invention relates to an analysis system, a server device, a control method and a recording medium. Background Art

[0002] In Japanese Patent Publication No. 2019-39896, a system having an analysis device configured in an analysis center and a server device configured in a server center is proposed as an analysis system for analyzing a sample collected from a subject. In this analysis system, the analysis device sends the analysis value obtained by analyzing the sample to the server device. The server device determines the presence or absence of a disease based on the received analysis value. The server device sends the determination result to the terminal device held by the subject. Summary of the invention

[0003] Here, as a method for appropriately judging the abnormality of a series of analysis processes in an analysis system, there is a method of evaluating the analysis value obtained by analyzing a system verification sample. When the analysis device judges that the analysis value of the system verification sample is within the normal range, it is judged that the analysis system is appropriate. On the other hand, when the analysis device judges that the analysis value of the system verification sample is not within the normal range, it is judged that an abnormality has occurred in the analysis system.

[0004] Thus, in order to ensure the analysis quality of the analysis device, it is very important to analyze the system verification sample in addition to the test object and evaluate its analysis value. Here, in the configuration in which the analysis device analyzes the sample and the analysis device evaluates its analysis value, sometimes the user of the analysis device conducts improper behavior on the evaluation result of the analysis value. Such improper behavior is, for example, tampering with the analysis value to make it fall within the normal range even if the analysis value of the system verification sample does not fall within the normal range. In the case of such improper behavior, the problem of not being able to properly detect abnormalities in a series of analysis processes in the analysis system occurs.

[0005] The present invention has been made to solve the above-mentioned technical problems, and an object of the present invention is to provide a technology capable of detecting abnormalities in a series of analysis processes in an analysis system.

[0006] An analysis system according to one scheme of the present disclosure comprises: a plurality of analysis devices, each of which is managed by one or more first facilities and analyzes a specimen of a subject; and a server device, which is managed by a second facility and can communicate with the plurality of analysis devices. The server device associates and stores a first reference specimen ID for identifying a first reference specimen having a first reference value for an inspection item and a first range based on the first reference value. The plurality of analysis devices analyze the provided first reference specimen without being notified of the first reference value, associate the analysis value of the first reference specimen with the first reference specimen ID and send it, and the server device outputs an abnormality signal when it is determined that the analysis value of the received first reference specimen does not belong to the first range corresponding to the received first reference specimen ID.

[0007] The above and other objects, features, aspects and advantages of the present invention will become more apparent from the following detailed description of the present invention when taken in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0008] Figure 1 It is a diagram showing a configuration example of an analysis system according to the present embodiment.

[0009] Figure 2 This is a diagram showing an example of the hardware configuration of a server device.

[0010] Figure 3 This is an example of a functional block diagram of an analysis device and a server device.

[0011] Figure 4 It is a figure which shows an example of a table.

[0012] Figure 5 It is a diagram showing the judgment of the analysis value of the QC sample by the server device.

[0013] Figure 6 This is a diagram showing the determination of the analysis value of the verification sample by the server device.

[0014] Figure 7 This is a diagram showing the dates on which abnormalities occurred in each of a plurality of analysis devices.

[0015] Figure 8 This is an example of a flowchart of processing in the controller of the server device. DETAILED DESCRIPTION

[0016] Hereinafter, embodiments of the present disclosure will be described in detail with reference to the accompanying drawings. In addition, the same or corresponding parts in the drawings are denoted by the same reference numerals, and their description will not be repeated.

[0017] [Overall structure of the analysis system]

[0018] Figure 1 is a diagram showing a configuration example of an analysis system 500 according to this embodiment. Figure 1 , the analysis system 500 includes a server device 100, M (M is an integer greater than or equal to 2) analysis devices 200m (m=1, ..., M), and a client device 300. Hereinafter, the "plurality of analysis devices 200m" may be referred to as "analysis devices 200". Figure 1 In order to simplify the drawing, one analysis device 200m is shown as "plurality of analysis devices 200m". Each of the plurality of analysis devices 200m is given an analysis device ID (Identification) for identifying the analysis device. The server device 100 can recognize the analysis device 200 individually based on the analysis device ID.

[0019] The server device 100 is installed in and managed by a service center 1100. The service center 1100 of this embodiment is an example of the "second facility" of the present disclosure. The analysis device 200 is installed in and managed by an analysis center 1200. The analysis center 1200 is an example of the "first facility" of the present disclosure.

[0020] The client device 300 is installed in a medical institution 1300. The service center 1100 has a person in charge of the service center 1100 (hereinafter also referred to as a user of the server device 100). The analysis center 1200 has a person in charge of the analysis center 1200 (hereinafter also referred to as a user of the analysis device 200).

[0021] In addition, the service center 1100 is a separate facility from the analysis center 1200. The person in charge of the service center 1100 can objectively determine whether an abnormality has occurred in a series of analysis processes in the analysis system based on the judgment result of the server device 100 without being influenced by the opinions of the person in charge of the analysis center 1200.

[0022] The person in charge of the medical institution 1300 (hereinafter also referred to as a user of the client device 300) exists in the medical institution 1300. The analysis system 500 of this embodiment is a system for determining at least one of the presence or absence of a disease and the type of disease in a subject by analyzing a specimen of the subject.

[0023] The server device 100 and the analysis device 200 are connected to the network in a communicable manner. Figure 2 The server device 100 and the client device 300 are connected to the network ( Figure 2 network 550) and are configured to be able to communicate with each other.

[0024] The analysis device 200 is a device for analyzing a subject's sample. The subject's sample is, for example, the subject's blood. The analysis device 200 can be any device as long as it can analyze the subject's sample. The analysis device 200 includes, for example, a liquid chromatograph, a gas chromatograph, a liquid chromatograph mass spectrometer, a gas chromatograph mass spectrometer, a scanning electron microscope, a transmission electron microscope, an energy dispersive fluorescence X-ray analyzer, a wavelength dispersive fluorescence X-ray analyzer, and a Fourier transform infrared spectrophotometer. The analysis device 200 can also include a photodiode array detector, a liquid chromatograph tandem mass analyzer, a gas chromatograph tandem mass analyzer, a liquid chromatograph mass spectrometer, a near-infrared spectrometer, a tensile tester, and a compression tester.

[0025] The server device 100 receives the analysis value of the sample obtained by the analysis of the analysis device 200 from the analysis device 200. Based on the analysis value, the server device 100 determines whether the subject from which the sample is collected has a disease and at least one of the types of the disease of the subject. The judgment of whether the subject has a disease and at least one of the types of the disease corresponds to the "examination item" of the present disclosure. The server device 100 sends the judgment result to the client device 300. In this embodiment, the analysis value is set to the concentration of a specified substance contained in the sample. In addition, the analysis value may also be the mass of a specified substance, or other indicators such as the ratio of the mass of a specified substance contained in the sample to the mass of the sample per unit mass (i.e., the mass ratio).

[0026] The client device 300 displays the determination result transmitted from the server device 100. The person in charge of the medical institution 1300 notifies the subject of the determination result.

[0027] Next, refer to Figure 1 , the process from the subject collecting the sample to the subject notifying the subject of the judgment result based on the sample is described. In addition, Figure 1 The solid arrows show the flow of information, and the dotted arrows show the flow of the subject, etc.

[0028] First, the client device 300 sends an ID generation request to the server device 100 according to the operation of the client device 300 by the person in charge of the medical institution 1300. Here, the ID generation request sent from the client device 300 is information for causing the server device 100 to generate a subject ID and a verification sample ID described later. In addition, the person in charge of the medical institution 1300 inputs the category of ID to be generated by the ID generation request (information indicating either the subject or the verification sample) and the number of IDs to be generated under the category. For example, when the person in charge of the medical institution 1300 wishes to generate 30 subject IDs and 1 verification sample ID, the information indicating that the server device 100 is to generate 30 subject IDs and 1 verification sample ID is input to the client device 300.

[0029] If the server device 100 receives the ID generation request, it generates a subject ID for identifying the subject and a verification sample ID for identifying the verification sample. The server device 100 sends the subject ID and the verification sample ID to the client device 300. The person in charge of the medical institution 1300 affixes a label on the container that records the subject ID sent from the server device 100. The verification sample ID will be described later. In addition, the subject ID, the QC (Quality control) sample ID described later, and the verification sample ID can be, for example, any of a digital label, a barcode label, and an RFID (radio frequency identifier).

[0030] In step (1), a sample is collected from a subject at the medical institution 1300. Next, in step (2), a container containing the sample is provided from the medical institution 1300 to the analysis center 1200. Next, in step (3), the analysis device 200 acquires an analysis value by analyzing the sample.

[0031] Next, in step (4), the analysis device 200 transmits the analysis value obtained by the analysis of the analysis device 200 to the server device 100. Next, in step (5), the server device 100 determines whether the subject from which the specimen is collected has a disease, etc., based on the analysis value of the specimen. Next, in step (6), the server device 100 transmits the determination result to the client device 300. Then, the determination result is notified to the subject through the medical institution 1300.

[0032] It is mentioned here that there is a method of checking the accuracy of the analysis value obtained by the analysis device 200 using a QC sample. The QC sample is, for example, a sample in which a predetermined substance (marker) used in determining the presence or absence of a disease is mixed at a predetermined concentration. The QC sample is prepared by the person in charge of the analysis center 1200, etc. The concentration of the predetermined substance in the QC sample is notified in advance to the user of the analysis device. In addition, an information processing device (not shown) attached to the analysis device 200 sends an ID generation request to the server device 100 according to the operation of the information processing device by the person in charge of the analysis center 1200. The information processing device is, for example, a PC (personal computer) or the like.

[0033] Here, the ID generation request sent from the information processing device attached to the analysis device 200 is information for causing the server device 100 to generate an ID of a QC sample (hereinafter also referred to as a QC sample ID). In addition, the person in charge of the analysis center 1200 inputs the category of the ID to be generated by the ID generation request (indicating the category of the QC sample) and the number of IDs to be generated under the category. For example, if the person in charge of the analysis center 1200 desires to generate three QC sample IDs, the person in charge of the analysis center 1200 inputs information indicating that the server device 100 generates three QC sample IDs into the information processing device.

[0034] When the server device 100 receives the ID generation request, it generates a QC sample ID and transmits the QC sample ID to the information processing device attached to the analyzer 200 .

[0035] After the QC sample is analyzed by the analyzing device 200, the user of the analyzing device 200 analyzes one or more samples and further analyzes the QC sample. The analyzing device 200 transmits the analysis value of the QC sample obtained by the analysis of the QC sample in step (4). In addition, in step (5), the server device 100 determines whether the analysis value of the QC sample is within the normal range. In the case where the analysis value of the QC sample is not within the normal range, some abnormality may have occurred in the analyzing device 200 after the analysis of the QC sample analyzed immediately after the QC sample. Therefore, when the user of the analyzing device determines that the analysis value of the QC sample is not within the normal range, the user determines that the analysis value of the sample analyzed after the QC sample analyzed immediately after the QC sample is unqualified. In the case where the analysis value of the QC sample is not within the normal range, in step (6), the server device 100 transmits the sample ID of the sample determined to be unqualified to the analyzing device 200 and the client device 300. The QC sample corresponds to the "second reference sample" of the present disclosure.

[0036] However, in the inspection using the QC sample, only the accuracy of the analysis value acquired by the analysis device 200 is inspected, so there may be a problem that it is impossible to detect whether there is an abnormality in a series of analysis processes in the analysis system 500.

[0037] Therefore, the analysis system 500 of the present embodiment detects whether there is an abnormality in a series of analysis processes in the analysis system 500. Here, a series of analysis processes is, for example, a process from when an operator of the analysis center 1200 arranges samples for analysis and the analysis is started by the analysis device 200, to when the analysis value obtained by the analysis is sent to the server device 100. An abnormality in a series of analysis processes is, for example, an error in the arrangement of samples on the system caused by the operator, an abnormality in the analysis function of the analysis device 200, and an abnormality in the function of sending the analysis value to the server device 100 described later caused by the analysis device 200.

[0038] The manufacturer 400 of the analysis device 200 manufactures a verification sample and provides the verification sample to the medical institution 1300. The verification sample is a sample used to detect whether there are abnormalities in a series of analysis processes in the analysis system. The verification sample is a sample mixed with a predetermined concentration of a specified substance (marker) used in the determination of a disease. The verification sample corresponds to the "first reference specimen" of the present disclosure. The concentration of the specified substance in the QC sample and the verification sample may be the same or different. In addition, the verification sample may be manufactured by other facilities instead of the manufacturer 400. Other facilities are, for example, subcontractors of the manufacturer 400 or group companies of the manufacturer 400.

[0039] As described above, the server device 100 generates a verification sample ID in response to an ID generation request from the client device 300. The verification sample ID is an ID for identifying the verification sample. The server device 100 stores the subject ID, verification sample ID, and QC sample ID in a table (see Figure 4 The server device 100 stores the table 1068 in the storage unit. In addition, the server device 100 stores the table in the storage unit for each analysis device ID.

[0040] The server device 100 receives the concentration of the predetermined substance of the verification sample from the manufacturer 400. The server device 100 associates the verification sample ID with the first range of the concentration of the predetermined substance based on the verification sample and stores it. In addition, the server device 100 receives the concentration of the predetermined substance of the QC sample from the analysis center 1200. The server device 100 associates the QC sample ID with the second range of the concentration of the predetermined substance based on the QC sample and stores it. The server device 100 associates the specimen ID with the third range of the concentration of the predetermined substance contained in the specimen and stores it.

[0041] As described above, the server device 100 transmits the verification sample ID to the client device 300. Alternatively, the server device 100 may transmit the specimen ID and the verification sample ID to a device different from the client device 300 as long as the device is installed in the medical institution 1300.

[0042] The person in charge of the medical institution 1300 affixes, to the container, a label on which the verification sample ID transmitted from the server device 100 is written. The person in charge of the medical institution 1300 stores the verification sample in the container on which the label on which the verification sample ID is affixed is attached.

[0043] In step (2), the container containing the verification sample is provided from the medical institution 1300 to the analysis center 1200 together with the container containing the sample. The analysis device 200 receives the verification sample in a manner that makes it impossible to distinguish the verification sample from the sample. This manner is, for example, such a manner that the container containing the sample and the container containing the verification sample are the same container, and the label recording the sample ID and the label recording the verification sample ID are the same label. In this way, the container containing the verification sample is provided to the analysis center 1200 together with the container containing the sample in a state where the container containing the verification sample is mixed with a plurality of containers containing the sample.

[0044] In step (3), the analysis device 200 acquires the analysis value of the verification sample by analyzing the verification sample. In addition, the user of the analysis device 200 can distinguish the QC sample from the test object and the verification sample. In addition, since the analysis device 200 receives the verification sample in a manner that cannot distinguish the verification sample from the test object, the user of the analysis device 200 cannot distinguish the test object from the verification sample. That is, the user of the analysis device 200 recognizes the container containing the verification sample as the container containing the test object.

[0045] In step (4), the analysis value of the verification sample is associated with the verification sample ID and sent. In addition, in step (4), the analysis device 200 can also be configured to also send sequence information showing the analysis order of the subject, QC sample, and verification sample to the server device 100. Hereinafter, "subject ID, analysis value of the subject associated with the subject ID, QC sample ID, analysis value of the QC sample associated with the QC sample ID, verification sample ID, and analysis value of the verification sample associated with the verification sample ID" are collectively referred to as "all analysis values." The all analysis values ​​of this embodiment are all IDs generated by the server device 100 (in this embodiment, such as Figure 4 As shown, the analysis values ​​corresponding to ID = 1 to 50) are shown.

[0046] In step (5), the server device 100 determines whether an abnormality has occurred in a series of analysis processes in the analysis system based on the analysis value of the verification sample associated with the verification sample ID.

[0047] When the server device 100 determines that an abnormality has occurred in a series of analysis processes in the analysis system 500 based on the analysis value of the verification sample, the server device 100 notifies the analysis device corresponding to the table of the first range used for the determination that an abnormality has occurred in a series of analysis processes in the analysis system. The notification is performed, for example, by outputting an abnormality signal to a display device (not shown) of the server device 100, thereby displaying an image showing that an abnormality has occurred in a series of analysis processes on the display device. As a result, the person in charge of the server device 100 learns that an abnormality has occurred in a series of analysis processes in the analysis system of the analysis device.

[0048] Furthermore, in step (6), an abnormality signal is sent to the analysis device 200 corresponding to the table of the first range used for the judgment in step (5). The abnormality signal is a signal indicating that an abnormality has occurred in a series of analysis processes in the analysis system 500. The analysis device 200 that receives the abnormality signal is informed of the situation that an abnormality has occurred in a series of analysis processes. The analysis device 200 displays an image showing that an abnormality has occurred in a series of analysis processes, for example, on a display device (not shown) of the analysis device 200. Thus, the user of the analysis device 200 can understand that an abnormality has occurred in the analysis device 200. In addition, the analysis device 200 can also be configured so that when the abnormality signal is received, the analysis device 200 stops the analysis processing of the specimen being executed. In addition, the server device 100 sends the abnormality signal to the client device 300.

[0049] [Hardware Configuration Example of Server Device]

[0050] Figure 2 1 is a diagram showing an example of the hardware configuration of the server device 100. The server device 100 includes a controller 150. The controller 150 includes a CPU (Central Processing Unit) 160, a ROM (Read Only Memory) 162, a RAM (Random Access Memory) 164, a HDD (Hard Disk Drive) 166, and a communication I / F (Interface) 168 as main components. Each component is connected to each other via a data bus.

[0051] The communication I / F 168 can communicate with the analysis device 200 and the client device 300 via the network 550 .

[0052] ROM162 stores programs executed by CPU160. RAM164 can temporarily store data generated by the execution of programs in CPU160 and data input via communication I / F168. RAM164 can function as a temporary data storage used as a work area. HDD166 is a non-volatile storage device. In addition, a semiconductor storage device such as a flash memory can also be used instead of HDD166.

[0053] In addition, the program stored in ROM 162 can also be stored in a storage medium and circulated as a program product. In addition, the program can be provided by an information provider as a so-called program product that can be downloaded through the Internet or the like. The server device 100 reads the program provided by the storage medium or the Internet or the like. The server device 100 stores the read program in a predetermined storage area (e.g., ROM 162). CPU 160 executes the above-mentioned display processing by executing the stored program.

[0054] The storage medium is not limited to DVD-ROM (Digital Versatile Disk Read Only Memory), CD-ROM (compact disc read-only memory), FD (Flexible Disk), and hard disk, and can be a medium that carries the program in a fixed manner, such as a magnetic tape, a cassette tape, an optical disc (MO (Magnetic Optical Disc) / MD (Mini Disc) / DVD (Digital Versatile Disc)), an optical card, a mask ROM, an EPROM (Electronically Programmable Read-Only Memory), an EEPROM (Electronically Erasable Programmable Read-Only Memory), a semiconductor memory such as a flash ROM, etc. Alternatively, the storage medium is a non-temporary medium that can be used by a computer to read the program, etc.

[0055] [Functional block diagram of analysis device and server device]

[0056] Figure 3This is an example of a functional block diagram of the analysis device 200 and the server device 100. The analysis device 200 includes an analysis unit 202 and an output unit 204. The server device 100 includes an input unit 102, a judgment unit 104, an output unit 112, and a storage unit 106. The input unit 102 and the output unit 112 are implemented by the communication I / F 168. The judgment unit 104 is implemented by the controller 150. The storage unit 106 is implemented by the ROM 162 or the RAM 164, etc.

[0057] The analysis unit 202 analyzes each of the sample, QC sample, and verification sample to obtain the analysis value of the sample, the analysis value of the QC sample, and the analysis value of the verification sample (see Figure 1 The output unit 204 sends all the analysis values ​​(the sample ID, the analysis value of the sample associated with the sample ID, the QC sample ID, the analysis value of the QC sample associated with the QC sample ID, the verification sample ID, and the analysis value of the verification sample associated with the verification sample ID) to the server device 100 (refer to Figure 1 Step (4)). In addition, the output unit 204 may be configured to output the acquired analytical value to the server device 100 whenever any analytical value among the analytical value of the sample, the analytical value of the QC sample, and the analytical value of the verification sample is acquired. In addition, the output unit 204 may be configured to send all analytical values ​​of the sample, the QC sample, and the verification sample to the server device 100 in a bundle. All analytical values ​​in this embodiment are as described later. Figure 4 Shown are the analysis values ​​of each of the 50 specimens, QC samples, and verification samples in total.

[0058] The input unit 102 receives input of all analysis values. The storage unit 106 stores a table 1068. As described above, the server device 100 generates a sample ID, a verification sample ID, and a QC sample ID, and stores the sample ID, the verification sample ID, and the QC sample ID in the storage unit 106 as the table 1068.

[0059] Figure 4 1068 is a diagram showing an example of the table 1068. As described above, the table 1068 is stored for each analysis device ID. Figure 4 In the example, ID is defined as 1 to 50. Figure 4 , the total number of samples, QC samples, and verification samples is 50. Figure 4 In the example, ID=1, 11, 48 are generated as QC sample IDs, ID=49 is generated as a verification sample ID, and other IDs are generated as subject IDs.

[0060] The determination unit 104 determines the categories of all the analysis values ​​based on the table 1068 and the plurality of IDs inputted by the input unit 102. Figure 4 In the example of , the determination unit 104 determines that the analysis values ​​associated with ID=1, 11, 48 are the analysis values ​​of the QC sample. In addition, the determination unit 104 determines that the analysis value associated with ID=49 is the analysis value of the verification sample. In addition, the determination unit 104 determines that the analysis values ​​associated with IDs other than ID=1, 11, 48, 49 are the analysis values ​​of the subject.

[0061] The determination unit 104 performs determination processing using the range corresponding to the type of the analysis value. In this embodiment, the first range is a range corresponding to the analysis value of the verification sample. The second range is a range corresponding to the analysis value of the QC sample. The third range is a range corresponding to the analysis value of the subject.

[0062] The first range is a range determined based on the concentration of a predetermined substance (a substance used for disease determination) mixed in the verification sample. The first range is a normal range of the analysis value of the verification sample and is an allowable tolerance.

[0063] The first range is a range consisting of an upper limit value obtained by adding a specified value to the concentration of a specified substance, and a lower limit value obtained by subtracting the specified value from the concentration of the specified substance. For example, when the concentration of the specified substance mixed in the verification sample is 5%, and the specified value is set to 0.2%, the first range becomes 4.8% to 5.2%. In addition, "5%" corresponds to the "first reference value" of the present disclosure. "4.8% to 5.2%" corresponds to the "first range based on the first reference value" of the present disclosure. In addition, in Figure 4 In FIG. 1 , the first range is shown as X1 to X2.

[0064] When the analysis device 200 is normal, if the analysis device 200 analyzes the verification sample having a concentration of 5% of the predetermined substance, a value belonging to the first range is output as the analysis value. However, when an abnormality occurs in a series of analysis processes in the analysis system 500, if the analysis device 200 analyzes the verification sample, a value not belonging to the first range may be output as the analysis value. The value not belonging to the first range refers to a value greater than the upper limit value of the first range or a value less than the lower limit value of the first range.

[0065] For example, when an abnormality occurs in the analysis function of the analyzer 200, the analysis value obtained by the analysis of the verification sample by the analyzer 200 may not belong to the first range. In addition, although the analysis function of the analyzer 200 does not occur abnormally, an abnormality may occur in the transmission function of the analyzer 200. The transmission function refers to a function of transmitting the analysis value obtained by the analysis function to the server device 100. When the analysis function of the analyzer 200 does not occur abnormally, the analyzer 200 obtains a value (for example, 5%) belonging to the first range as the analysis value of the verification sample. However, when an abnormality occurs in the transmission function, for example, the verification sample ID and the subject ID may be mistakenly replaced and sent. This case refers to a case where the analysis value (for example, 8%) of the subject is mistakenly associated with the verification sample ID and sent, and the analysis value (for example, 5%) of the verification sample is mistakenly associated with the subject ID and sent. In this case, the judgment unit 104 judges that the analysis value (8%) of the subject does not belong to the first range. In addition, when an operator makes a sample arrangement error in the system, the analysis value obtained by analyzing the verification sample by the analyzer 200 may not fall within the first range. In addition, the abnormality in a series of analysis processes may include at least one of an abnormality in a signal line from the analyzer 200 to the network 550, the network 550, a signal line from the network 550 to the server 100, and an abnormality in a receiving function of the server 100.

[0066] In this way, when the sample (verification sample) associated with the verification sample ID does not belong to the first range, it is considered that an abnormality may have occurred in a series of analysis processes (for example, the analysis function or the transmission function).

[0067] In addition, the second range is a range determined based on the concentration of a specified substance mixed in the QC sample. The second range is the normal range of the analysis value of the QC sample, and is an allowable tolerance. The second range is a range consisting of an upper limit value obtained by adding a specified value to the concentration of the specified substance, and a lower limit value obtained by subtracting the specified value from the concentration of the specified substance. For example, when the concentration of the specified substance mixed in the verification sample is 7%, and the specified value is set to 0.2%, the second range becomes 6.8% to 7.2%. In addition, "7%" corresponds to the "second reference value" of the present disclosure. "6.8% to 7.2%" corresponds to the "second range based on the second reference value" of the present disclosure. In addition, in Figure 4 In FIG. 1 , the second range is shown as Y1 to Y2.

[0068] When the analysis function of the analyzer 200 is normal, if the analyzer 200 analyzes the QC sample having a concentration of 7% of the specified substance, a value belonging to the second range is output as the analysis value. However, when the analysis function of the analyzer 200 is abnormal, if the analyzer 200 analyzes the QC sample, a value not belonging to the second range is output as the analysis value. The value not belonging to the second range refers to a value greater than the upper limit value of the second range or a value less than the lower limit value of the second range. The processing of the case where the analysis value of the QC sample does not belong to the second range is described in Figure 5 Described in detail.

[0069] The third range is a range used for the analysis value of the sample. For example, when the judgment unit 104 judges that the analysis value of the sample belongs to the third range, it is judged that the subject from which the sample was collected does not have a disease. When the judgment unit 104 judges that the analysis value of the sample does not belong to the third range, it is judged that the subject from which the sample was collected has a disease. Furthermore, it can also be set that when the analysis value of the sample does not belong to the third range, the judgment unit 104 judges that the analysis value belongs to a specified range, it is judged that the subject from which the sample was collected has a first disease, and when it is judged that the analysis value belongs to a specific range, it is judged that the subject from which the sample was collected has a second disease. In addition, in Figure 4 In FIG. 1 , the third range is shown as Z1 to Z2.

[0070] return Figure 3 Description. When the judgment unit 104 judges that the analysis value of the verification sample does not belong to the first range, the display device of the server device 100 notifies the analysis device 200 corresponding to the table of the first range that an abnormality has occurred in a series of analysis processes in the analysis system 500. This notification is performed by outputting an abnormal signal to the display device of the server device 100. Through this notification, the user of the server device 100 can detect the abnormality of a series of analysis processes in the analysis system 500. Further, the judgment unit 104 sends an abnormal signal to the analysis device 200 corresponding to the table of the first range (that is, the analysis device 200 that sent the analysis value of the verification sample that does not belong to the first range) via the output unit 112. The analysis device 200 that receives the abnormal signal notifies the abnormality in a series of analysis processes. Through this notification, the user of the analysis device 200 can detect the abnormality of a series of analysis processes in the analysis system 500. In addition, the analysis device 200 can also be set to stop the analysis of the specimen being executed when the abnormal signal is received. This can prevent the subject from being analyzed in the analysis device 200 in which an abnormality occurs.

[0071] When the determination unit 104 determines that the analysis value of the verification sample is within the first range, no abnormal signal is sent. Alternatively, when the determination unit 104 determines that the analysis value of the verification sample is within the first range, a normal signal indicating that a series of analysis processes are normal may be sent to the analysis device 200 via the output unit 112.

[0072] The determination unit 104 transmits the determination result based on the analysis value of the QC sample to the analyzer 200 and the client device 300 via the output unit 112. In addition, the determination unit 104 transmits the determination result based on the analysis value of the sample to the client device 300 via the output unit 112.

[0073] Thus, in the present embodiment, the server device 100 managed by the service center 1100 can detect abnormalities in a series of analysis processes based on the analysis value for system verification and the first range, rather than the analysis device 200 managed by the analysis center 1200. Thus, the server device 100 can detect abnormalities in a series of analysis processes in the analysis system without the user of the analysis device or the like performing an unauthorized act on the evaluation result of the analysis value of the first reference sample. In addition, the unauthorized act is, for example, tampering with the analysis value to make it fall within the normal range even if the analysis value of the system verification sample does not fall within the normal range.

[0074] Furthermore, in order to ensure the accuracy of the examination related to the disease of the subject, the analysis device 200 needs to analyze the subject in a state where no abnormality occurs in a series of analysis processes in the analysis system 500. However, it is difficult for the user of the analysis device 200 to confirm whether an abnormality occurs in a series of analysis processes because the analysis centers 1200 are dispersed in various places and it is difficult to ensure personnel who are proficient in detecting abnormalities in a series of analysis processes.

[0075] Therefore, when the analysis value of the verification sample does not fall within the first range, since there is a possibility that an abnormality has occurred in a series of analysis processes, the analysis device 200 that has received the abnormality signal notifies that an abnormality has occurred in a series of analysis processes. Thus, the user of the analysis center 1200 and the like can be informed of the abnormality in a series of analysis processes in the analysis system 500. In addition, since it is possible to prevent the analysis device 200 from analyzing the subject in a state where an abnormality has occurred in a series of analysis processes in the analysis system 500, the accuracy of the examination related to the disease of the subject can be guaranteed.

[0076] Furthermore, assuming that when the analysis device 200 analyzes the specimen and the verification sample, the user of the analysis device 200 can distinguish between the container containing the specimen and the container containing the verification sample, the user of the analysis device 200 may perform the above-mentioned improper behavior on the evaluation result (or analysis value) of the analysis value of the verification sample. In view of such a situation, the container containing the specimen and the container containing the verification sample are provided from the medical institution 1300 to the analysis center 1200 in a state where the user of the analysis device 200 and the analysis device 200 cannot distinguish them. That is, in the case of Figure 1 As described in step (2) of , the analysis device 200 receives the verification sample in a state where the verification sample cannot be distinguished from the sample. Thus, the analysis device 200 user does not need to pay attention to the analysis device 200 to check whether there is an abnormality, and the server device 100 can determine whether there is an abnormality in the analysis device.

[0077] In addition, as in Figure 1 As described in , the specimen is provided from the medical institution 1300 to the analysis center 1200. On the other hand, the verification sample is provided from the manufacturer 400 to the medical institution 1300 after being manufactured by the manufacturer 400, and is provided from the medical institution 1300 to the analysis center 1200. In this way, the specimen and the verification sample are provided to the analysis device 200 in different paths. Therefore, since the server device 100 can judge whether the analysis device 200 has an abnormality using the analysis value of the verification sample provided in a different path from the specimen, the user of the analysis device 200 can make an objective judgment. In addition, since the server device 100 can judge whether the analysis device 200 has an abnormality using the analysis value of the verification sample manufactured by the manufacturer 400, the manufacturer 400 can provide the analysis system 500 with the manufacturer 400 as the main body.

[0078] In addition, the server device 100 may also be configured to Figure 4 The analysis values ​​are stored in table 1068 in correspondence with ID1 to ID50. Figure 4 The server device 100 can also be configured to store in the table 1068 whether the analysis value of the verification sample belongs to the first range, whether the analysis value of the QC sample belongs to the second range, and whether the analysis value of the subject belongs to the third range (i.e., the presence or absence of a disease). In this way, the server device 100 can uniformly manage the analysis results of the analysis device 200 and whether the analysis values ​​belong to the corresponding ranges. In addition, as in Figure 7As described in , when the analysis system 500 includes a plurality of analysis devices 200 , analysis values ​​and whether the analysis values ​​belong to a corresponding range may be stored for each of the plurality of analysis devices 200 .

[0079] In addition, it can be considered that each of the multiple analyzers 200m generates a sample ID, a verification sample ID, and a QC sample ID. However, in this configuration, different system IDs are generated according to the analyzer 200, and as a result, errors are likely to occur in ID management due to the complexity of ID management. Therefore, in this embodiment, the server device 100 generates a sample ID, a verification sample ID, and a QC sample ID for each of the multiple analyzers 200m. Therefore, the server device 100 can uniformly manage the sample ID, the verification sample ID, and the QC sample ID for each of the multiple analyzers 200m. Furthermore, the server device 100 performs "detection of abnormalities in a series of analysis processes (judgment using verification samples)", "judgment using QC samples", and "judgment of whether the subject has a disease and at least one of the types of diseases". Therefore, the analysis system 500 of this embodiment can provide services such as "generation of subject IDs, verification sample IDs and QC sample IDs for each of multiple analysis devices 200m", "detection of abnormalities in a series of analysis processes (determination using verification samples)", "determination using QC samples" and "determination of whether the subject has a disease and at least one of the types of the disease" performed by the server device 100.

[0080] [About the analysis of QC samples and verification samples]

[0081] Next, the details of the determination of the analysis value of the QC sample by the server device 100 will be described. Figure 5 1 is a diagram for explaining the determination of the analysis value of the QC sample by the server device 100. Figure 5 and the following Figure 6 In the example of , the test object is shown as a dot pattern, the QC sample is shown as a hatched pattern with inclined lines rising to the right, and the verification sample is shown as a hatched pattern with inclined lines falling to the right. Figure 5 and the following Figure 6 In the example of , the cases where the QC sample IDs are 1, 11, 44, and 48 are shown, and the case where the verification sample ID is 49 is shown. Figure 5 In the example of , the case where the analysis value of the verification sample belongs to the first range (that is, the case where the analysis value of the verification sample is normal) is shown.

[0082] As described above, the analysis device 200 analyzes one QC sample, then analyzes a verification sample or one or more specimens, and then further analyzes one QC sample. Figure 5 In the example shown in FIG. 1 , the analysis value of the QC sample with QC sample ID=44 is determined by the determination unit 104 (see Figure 3 ) is judged as unqualified. In this case, the judgment unit 104 judges that the analysis value of the sample (samples with ID=12 to 43, 45 to 50) analyzed after the analysis of the QC sample (QC sample with QC sample ID=11) analyzed immediately after the QC sample (QC sample with QC sample ID=44) judged as unqualified is unqualified.

[0083] like Figure 5 As shown, the server device 100 can determine whether the analysis value of the sample is acceptable or not by using a QC sample different from the verification sample.

[0084] Figure 6 The case where the analysis value of the verification sample does not fall within the first range (that is, the case where the analysis value of the verification sample is abnormal) is shown. Figure 6 In the example of , the case where the analysis values ​​of all QC samples are judged to be acceptable is shown.

[0085] like Figure 6 As shown, when the determination unit 104 determines that the analysis value of the verification sample does not fall within the first range, the determination unit 104 determines that the analyzer 200 is abnormal, and the server device 100 notifies the abnormality and outputs an abnormality signal to the analyzer 200 and the client device 300.

[0086] [Management of analysis devices by server devices]

[0087] Next, the management of the analysis device 200 by the server device 100 will be described. The server device 100 may be configured to manage whether or not there is an abnormality in a series of analysis processes of each of the plurality of analysis devices 200m. Figure 7 2 is a diagram showing the dates on which abnormalities occurred in each of the plurality of analysis devices 200m. Figure 7 As shown in FIG. 1 , an analysis device ID is set for each of the plurality of analysis devices 200 m. Figure 7 In the example, 200A1, 200A2, 200A3, ... are set as the analysis device IDs for the plurality of analysis devices 200m. Hereinafter, the analysis device IDs are set as the reference numerals of the plurality of analysis devices 200m. The server device 100 holds Figure 7 The table shown.

[0088] exist Figure 7 In the example of , the date when the abnormality occurred in the analysis device 200A1 is shown as October 13, 2019. Figure 7 In the example of , it is shown that no abnormality occurs in the analysis device 200A2. Figure 7In the example, it is shown that the date when the abnormality occurred in the analysis device 200A3 is February 10, 2019.

[0089] like Figure 7 As shown in FIG. 1 , the server device 100 stores the abnormality occurrence of each of the plurality of analysis devices 200. Therefore, the administrator of the server device 100 can understand whether an abnormality has occurred in each of the plurality of analysis devices 200m. Figure 7 Although not shown in the figure, the server device 100 may be configured to store the analysis value of the sample output by the analysis device for each analysis device. In addition, the server device 100 may be configured to store whether the analysis value of the QC sample is passed or failed.

[0090] [Flowchart of Processing Performed in Controller 150]

[0091] Figure 8 FIG. 1 is an example of a flowchart of a process performed in the controller 150 of the server device 100. Figure 8 In the description of , the specimen ID, the verification sample ID, and the QC sample ID are collectively referred to as “N.” N is a numerical value indicated by the above-mentioned sequence information.

[0092] First, in step S1, all analysis values ​​are received by the server device 100. Next, in step S2, the controller 150 sets N to an initial value (in Figure 8 In the example, it is "1"). In step S4, the controller 150 obtains the analysis value corresponding to N from the plurality of analysis values. In step S6, the controller 150 determines whether N is the subject ID. When it is determined that N is the subject ID (yes in step S6), in step S8, the determination unit 104 in the controller 150 performs a disease determination based on the third range and the analysis value corresponding to N (i.e., the analysis value of the subject with subject ID=N). In step S10, the controller 150 stores the determination result of step S8 in the storage unit 106.

[0093] In step S12, the controller 150 determines whether all determinations of all analysis values ​​have been completed. If it is determined that the determinations of all analysis values ​​have been completed (Yes in step S12), in step S16, the server device 100 transmits the determination results of all the subjects to the client device 300. On the other hand, if it is determined that the determinations of all analysis values ​​have not been completed (No in step S12), in step S14, the controller 150 increments N by 1, and the process returns to step S4.

[0094] If it is determined that N is not the subject ID (No in step S6), in step S18, the controller 150 determines whether N is the verification sample ID. If it is determined that N is the verification sample ID (Yes in step S18), in step S20, the determination unit 104 in the controller 150 determines whether the analysis value corresponding to N (i.e., the analysis value of the verification sample) belongs to the first range (refer to Figure 3 ). When the analysis value corresponding to N is judged to belong to the first range (step S20 is yes), the process is advanced to step S12. On the other hand, when the analysis value corresponding to N is judged not to belong to the first range (step S20 is no), the process is advanced to step S22. In step S22, the controller 150 notifies of the abnormality. And, in step S22, the controller 150 sends an abnormality signal to the analysis device 200 and the client device 300. The analysis device 200 notifies the user of the analysis device 200 that the abnormality has occurred in the analysis device 200. In addition, the client device 300 notifies the person in charge of the medical institution 1300 that the abnormality has occurred in the analysis device 200. The process is then terminated.

[0095] In addition, when it is determined that N is not any of the subject ID and the verification sample ID (No in step S18), N is the QC sample ID. In this case, in step S24, the determination unit 104 in the controller 150 determines whether the analysis value corresponding to N (i.e., the analysis value of the QC sample) belongs to the second range (refer to Figure 3 ). When the analysis value corresponding to N is determined to be within the second range (step S24: Yes), the process proceeds to step S12. On the other hand, when the analysis value corresponding to N is determined not to be within the second range (step S24: No), the process proceeds to step S26.

[0096] In step S26, the controller 150 performs the Figure 5 As described in the description, the QC sample ( Figure 5 The first QC sample (QC sample with ID = 44) Figure 5 The analysis of the QC sample with ID=11) is more accurate than the previously analyzed sample ( Figure 5 The determination result of the subjects with IDs of 2 to 10 is sent to the client device 300. In step S26, the controller 150 displays the other subjects (ie, Figure 5 The client device 300 sends information that the analysis value of the sample with ID=12 to 43 and ID45 to 50 is unqualified to the client device 300 and the analysis device 200. The client device 300 notifies the person in charge of the medical institution 1300 of the sample ID of the unqualified sample based on the information.

[0097] As in Figure 8 As described in , when it is determined that the analysis value of the verification sample does not belong to the first range (step S20 is No), since the process of step S16 is not executed, the controller 150 controls the analysis result of the sample to be sent to the client device 300. Therefore, the server device 100 can prevent the judgment result obtained in the state where an abnormality occurs in a series of analysis processes from being sent to the client device 300.

[0098] In addition, in the judgment of whether N is the verification sample ID described in step S18, if the judgment is no, the controller 150 may also be set to execute the judgment of whether N is the QC sample ID. In this judgment, if the judgment is yes, the process is advanced to step S24. On the other hand, in this judgment, if the judgment is no, the server device 100 may also be set to execute error notification. In this judgment, the case of no judgment refers to the case where an ID different from the ID generated by the server device 100 is sent to the analysis device 200. Through this error notification, the user of the server device 100 can be informed that an ID different from the ID generated by the server device 100 is sent to the analysis device 200.

[0099] [Modifications]

[0100] (1) In the above embodiment, the configuration in which the output destination of the abnormality signal from the server device 100 is the analysis device 200 is described. However, the output destination of the abnormality signal may be another device. For example, the other device may be a device installed in the service center 1100. When the other device receives the abnormality signal, it notifies the person in charge of the service center 1100 or the like of the abnormality of the analysis device 200. The person in charge of the service center 1100 notifies the user of the analysis device 200 of the abnormality of the analysis device 200 via an email or the like.

[0101] (2) In the above embodiment, the configuration is described in which the container containing the specimen and the container containing the verification sample are provided to the analysis center 1200 in a state in which the user of the analysis device 200 and the analysis device 200 cannot distinguish them. However, the container containing the specimen and the container containing the verification sample may be provided to the analysis center 1200 in a state in which the user of the analysis device 200 and at least one of the analysis device 200 can distinguish them.

[0102] (3) In the above-mentioned embodiment, the structure in which the subject has the specimen collected at the medical institution 1300 has been described (see Figure 1However, it is also possible to set the subject to collect the specimen (e.g., sputum of the subject) by the subject himself. In this case, the client device 300 becomes a device held by the subject (e.g., a smart phone, etc.). In addition, in this case, the verification sample is provided to the analysis center 1200 with the source of the verification sample as a virtual subject.

[0103] In the above embodiment, the server device 100 transmits the judgment result of the subject to the client device 300. However, the server device 100 may print the judgment result of the subject, and the person in charge of the service center 1100 may notify the subject by mailing a paper with the judgment result printed thereon.

[0104] (4) In the above embodiment, the configuration in which the analyzer 200 analyzes a verification sample or one or more test subjects after analyzing one QC sample is described. That is, if the analyzer 200 sets the period for analyzing the verification sample or one or more test subjects as a "predetermined period", the analyzer 200 analyzes the QC sample every time a predetermined period has passed. The predetermined period may also be set to another period. The predetermined period may be set to a time period, for example. The predetermined period may be set to one day, for example.

[0105] (5) In the above-mentioned embodiment, the structure in which the server device 100 performs the judgment of whether the analysis value of the QC sample belongs to the second range is described. With such a structure, the server device 100 can uniformly perform the judgment of the analysis value of the specimen, the judgment of the analysis value of the QC sample, and the judgment of the analysis value of the verification sample. In addition, the server device 100 can uniformly store the judgment results of the analysis value of the specimen, the judgment results of the analysis value of the QC sample, and the judgment results of the analysis value of the verification sample. In addition, it can also be set that the analysis device 200 performs the judgment of whether the analysis value of the QC sample belongs to the second range. According to such a structure, when the analysis device 200 judges that the analysis value of the QC sample does not belong to the second range, the analysis device 200 can also be set to perform abnormal notification. By performing this abnormal notification, the user of the analysis device 200 can immediately understand that an abnormality may occur in the analysis device 200.

[0106] [plan]

[0107] Those skilled in the art will appreciate that the above-mentioned multiple exemplary embodiments are specific examples of the following schemes.

[0108] (Item 1) An analysis system of one scheme comprises: a plurality of analysis devices, each of which is managed by one or more first facilities and analyzes a subject's specimen; a server device, which is managed by a second facility and can communicate with the plurality of analysis devices, the server device associating and storing a first reference subject ID for identifying a first reference subject having a first reference value for an examination item with a first range based on the first reference value, the plurality of analysis devices analyzing a provided first reference subject without being notified of the first reference value, associating and sending the analysis value of the first reference subject with the first reference subject ID, and the server device outputting an abnormality signal when determining that the received analysis value of the first reference subject does not belong to the first range corresponding to the received first reference subject ID.

[0109] According to the analysis system of item 1, the server device managed by the second facility outputs an abnormal signal when it is determined that the analysis value of the first reference sample obtained by the analysis device managed by the first facility does not fall within the first range. Therefore, it is possible to detect abnormalities in a series of analysis processes in the analysis system without the user of the analysis device etc. engaging in improper behavior on the judgment result of the analysis value of the first reference sample.

[0110] (Item 2) In the analysis system described in Item 1, the plurality of analysis devices receive the first reference sample in a state in which the first reference sample cannot be distinguished from the sample.

[0111] According to the second analysis system, the analysis device cannot distinguish the sample from the first reference sample, so the user can be aware of abnormalities in a series of analysis processes in the analysis system without having to check whether the analysis device has abnormalities.

[0112] (Item 3) In the analysis system of Item 1 or Item 2, an analysis device outputs an abnormal signal to a first reference sample that sends an analysis value that does not belong to a first range corresponding to a first reference sample ID, and the analysis device responds to receiving the abnormal signal by stopping analysis of the sample.

[0113] According to the analysis system of item 3, it is possible to prevent the analysis of the sample in the analysis device in a state where an abnormality occurs in a series of analysis processes in the analysis system.

[0114] (Item 4) In the analysis system described in any one of Items 1 to 3, the analysis system includes a server device different from the analysis device, and the server device stores, for each analysis device, a situation where an abnormality of the analysis device occurs.

[0115] According to the analysis system of item 4, the server device can centrally manage the abnormality occurring in each analysis device.

[0116] (Item 5) In the analysis system described in any one of Items 1 to 4, the sample and the first reference sample are provided to the plurality of analysis devices via different paths.

[0117] According to the analysis system of item 5, the server device can determine abnormality in a series of analysis processes in the analysis system using the first reference sample provided through a different path from the sample, and thus can make an objective determination.

[0118] (Item 6) In the analysis system described in any one of Items 1 to 5, the first reference sample is manufactured by a manufacturer of the analysis device.

[0119] According to the analysis system of item 6, the server device can determine whether an abnormality has occurred in the analysis device using the analysis value of the first reference sample manufactured by the manufacturer of the analysis device. Therefore, the manufacturer of the analysis device can provide an analysis system mainly based on the manufacturer of the analysis device.

[0120] (Item 7) In the analysis system described in any one of Items 1 to 6, a plurality of analysis devices analyze a subject, associate the subject with a subject ID for identifying the subject, and send the analysis value of the subject to a server device, and when the server device determines that the analysis value of the received first reference subject does not fall within a first range corresponding to the received first reference subject ID, the server device controls notification of the analysis result of the subject to the subject.

[0121] According to the analysis system of item 7, it is possible to prevent the judgment result acquired in a state where an abnormality occurs during a series of analysis processes from being transmitted to the client device 300 .

[0122] (Item 8) In the analysis system described in any one of Items 1 to 7, the server device associates and stores a second reference subject ID for identifying a second reference subject having a second reference value for an inspection item with a second range based on the second reference value, a plurality of analysis devices are notified of the second reference value and analyze the provided second reference subject, associate the analysis value of the second reference subject with the second reference subject ID and send the analysis value, and when the server device determines that the analysis value of the received second reference subject does not belong to the second range corresponding to the received second reference subject ID, the server device determines that the analysis value of a subject analyzed after analyzing the second reference subject immediately following the second reference subject is unqualified.

[0123] According to the analysis system of claim 8, the accuracy of the analysis value of the sample can be checked using the second reference sample different from the first reference sample.

[0124] (Item 9) A server device included in the analysis system described in any one of Items 1 to 8.

[0125] According to the server device of item 9, the server device outputs an abnormal signal when it is determined that the analysis value of the first reference sample having the first reference value of the inspection item does not fall within the first range based on the first reference value, so that the user of the analysis device and the like can understand the abnormality of a series of analysis processes in the analysis system.

[0126] (Item 10) A control method of a scheme is a control method of a server device, wherein the server device can communicate with multiple analysis devices that are respectively managed by one or more first facilities and analyze samples of a subject, and associates and stores a first reference sample ID for identifying a first reference sample having a first reference value for an examination item with a first range based on the first reference value, and is managed by a second facility. The control method includes: a step of receiving the first reference sample ID and an analysis value of the first reference sample associated with the first reference sample ID; and a step of outputting an abnormal signal when it is determined that the analysis value of the received first reference sample does not belong to the first range corresponding to the received first reference sample ID.

[0127] According to the control method of item 10, since the server device managed by the second facility outputs an abnormal signal when it is determined that the analysis value of the first reference specimen by the analysis device managed by the first facility does not fall within the first range, it is possible to detect abnormalities in a series of analysis processes in the analysis system without the user of the analysis device etc. engaging in improper behavior on the judgment result of the analysis value of the first reference specimen.

[0128] (Item 11) A control method of a scheme, which is a program for controlling a computer, wherein the computer can communicate with multiple analysis devices that are respectively managed by one or more first facilities and analyze the subjects' samples, and the first benchmark subject ID for identifying the first benchmark subject having the first benchmark value of the examination item is associated with and stored with the first range based on the first benchmark value, and is managed by a second facility, wherein the program causes the computer to execute the following steps: a step of receiving the first benchmark subject ID and the analysis value of the first benchmark subject associated with the first benchmark subject ID; and a step of outputting an abnormal signal when it is determined that the received analysis value of the first benchmark subject does not belong to the first range corresponding to the received first benchmark subject ID.

[0129] According to the control procedure of item 11, since the computer managed by the second facility outputs an abnormal signal when it determines that the analysis value of the first reference specimen by the analysis device managed by the first facility does not fall within the first range, it is possible to detect abnormalities in a series of analysis processes in the analysis system without the user of the analysis device or the like engaging in improper behavior on the judgment result of the analysis value of the first reference specimen.

[0130] The embodiments disclosed this time are also intended to be implemented in appropriate combinations within the scope of technical non-contradiction. Furthermore, the embodiments disclosed this time should be considered to be illustrative in all aspects and not restrictive. The scope of this embodiment is not shown by the description of the above-mentioned embodiments, but by the claims, and also includes all changes within the meaning and scope equivalent to the claims.

[0131] The embodiments of the present invention have been described above, but the embodiments disclosed this time should be considered to be illustrative in all aspects and not restrictive. The scope of the present invention is indicated by the claims, and all modifications within the meaning and scope equivalent to the claims are also included.

Claims

1. An analysis system, characterized in that: have: a plurality of analysis devices, each of which is managed by one or more first facilities and analyzes a sample of a subject; a server device managed by the second facility and capable of communicating with the plurality of analysis devices, The server device associates and stores a first reference subject ID for identifying a first reference subject having a first reference value of a test item and a first range based on the first reference value. The plurality of analyzers analyze the provided first reference sample without being notified of the first reference value, and transmit the analysis value of the first reference sample in association with the first reference sample ID. The server device outputs an abnormality signal when determining that the received analysis value of the first reference sample does not belong to the first range corresponding to the received first reference sample ID. The plurality of analyzers receive the first reference sample in a state where the first reference sample cannot be distinguished from the sample.

2. The analysis system according to claim 1, characterized in that the server device outputting the abnormal signal to the analyzer that has transmitted the analysis value of the first reference sample that does not belong to the first range corresponding to the first reference sample ID, The analyzing device stops analyzing the subject in response to receiving the abnormal signal.

3. The analysis system according to claim 1, characterized in that The server device stores, for each of the plurality of analyzing devices, a state in which an abnormality has occurred in the analyzing device.

4. The analysis system according to claim 1, characterized in that The sample and the first reference sample are provided to the plurality of analyzers via different routes.

5. The analysis system according to claim 1, characterized in that The first reference sample is manufactured by a manufacturer of the analyzer.

6. The analysis system according to claim 1, characterized in that The plurality of analysis devices analyze the subject, associate the analysis value of the subject with the subject ID for identifying the subject, and transmit the analysis value of the subject to the server device. The server device controls notification of the analysis result of the sample to the subject, when determining that the received analysis value of the first reference sample does not belong to the first range corresponding to the received first reference sample ID.

7. The analysis system according to claim 1, characterized in that The server device associates and stores a second reference subject ID for identifying a second reference subject having a second reference value of a test item determined therein with a second range based on the second reference value. The plurality of analysis devices analyze the provided second reference sample upon being notified of the second reference value, and transmit the analysis value of the second reference sample in association with the second reference sample ID. When the server device determines that the analysis value of the received second reference sample does not belong to the second range corresponding to the received second reference sample ID, it determines that the analysis value of the sample analyzed after analyzing the second reference sample immediately following the second reference sample is unqualified.

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