Specimen analysis system

The automated specimen analysis system addresses the manual burden of preparing accuracy control substances by automatically starting and measuring units, thereby reducing user man-hours.

JP2025071141AActive Publication Date: 2025-05-02SYSMEX CORP
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Patent Information

Application Number
JP2025023589
Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Filing Date
2025-02-17
Publication Date
2025-05-02
Estimated Expiration
2041-03-04

AI Technical Summary

Technical Problem

Existing specimen analysis systems require manual preparation and measurement of accuracy control substances, leading to increased man-hours for users.

Method used

A method and system for automatically starting measurement units, supplying accuracy control specimens, and measuring them, allowing for automated precision control in specimen analysis systems.

Benefits of technology

Reduces the number of man-hours required for users to start and shut down specimen analysis systems by automating the startup and measurement processes.

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Abstract

To provide a control method of a specimen analysis system having a small user's work burden in measurement of a quality control substance.SOLUTION: A control method of a specimen analysis system is applied to a specimen analysis system including at least one measurement unit. The method includes automatic activation of one or multiple measurement units included in the specimen analysis system according to a schedule previously registered by a user, automatic supply of a quality control specimen to the activated measurement unit, and measurement of a quality control specimen by the activated measurement unit.SELECTED DRAWING: Figure 23
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Description

[Technical field]

[0001] The present invention relates to a control method for a sample analysis system and a sample analysis system. [Background technology]

[0002] Conventionally, sample analysis systems equipped with an analyzer for analyzing samples containing cells derived from living organisms such as blood cells have been widely known. In such systems, it is necessary to periodically check that there are no abnormalities in the measurement results of the analyzer using a quality control material containing cells of known concentrations, thereby managing the measurement accuracy.

[0003] Patent Document 1 discloses a sample analysis system including multiple analyzers and a startup controller. The startup controller is configured to selectively start up a target analyzer among the multiple analyzers at a specified time. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] JP 2020-094843 A Summary of the Invention [Problem to be solved by the invention]

[0005] In a laboratory, quality control substances are generally measured before routine testing of samples to control the quality of an analyzer. In the system of Patent Document 1, the analyzer can be started automatically, but in order to perform quality control before the start of routine testing, the user must prepare quality control substances and perform measurements, leaving room for improvement in terms of reducing the user's workload.

[0006] An object of the present invention is to reduce the number of steps required by a user. [Means for solving the problem]

[0007] A method for controlling a sample analysis system according to the present invention is a method for controlling a sample analysis system including at least one measurement unit, which includes automatically activating one or more measurement units included in the sample analysis system according to a schedule registered in advance by a user, automatically supplying a quality control sample to the activated measurement unit, and measuring the quality control sample by the activated measurement unit.

[0008] The sample analysis system of the present invention includes one or more measurement units, a supply unit that stores quality control samples and supplies the quality control samples to the measurement units, a memory unit that stores a schedule registered in advance by a user, and a control unit. The control unit starts up the one or more measurement units according to the schedule stored in the memory unit, the supply unit automatically supplies the quality control samples to the started measurement units, and the measurement units measure the supplied quality control samples.

[0009] The method of controlling a sample analysis system of the present invention includes accepting designation of one or more devices from a user, and shutting down the designated device(s).

[0010] The sample analysis system of the present invention comprises a plurality of devices for processing samples and a control unit, and the control unit receives designation of one or more devices among the plurality of devices from a user and shuts down the designated device(s). Effect of the Invention

[0011] According to the present invention, the start-up of the measurement unit and the measurement of the quality control substance can be automated, thereby reducing the number of steps required by the user to start a test. Also, according to the present invention, the number of steps required by the user to shut down the sample analysis system can be reduced. [Brief description of the drawings]

[0012] [Figure 1] FIG. 1 is a schematic diagram of a sample analysis system. [Diagram 2]FIG. 1 is a schematic diagram of a sample analysis system. [Diagram 3] 2 is a block diagram showing the interconnection relationships of each unit that constitutes the sample analysis system. FIG. [Figure 4] 2 is a perspective view showing a sample container and a sample rack in which the sample containers are accommodated. FIG. [Diagram 5] 2 is a diagram showing a schematic configuration of a measurement unit and a transport unit that make up the sample analysis system. FIG. [Figure 6] FIG. 2 is a diagram illustrating a schematic configuration of a measurement unit and a transport unit. [Figure 7] FIG. 2 is a perspective view of a supply unit constituting the sample analyzing system. [Figure 8] FIG. 2 is a diagram showing a schematic configuration (internal layout) of a supply unit, in which a sample rack is set on a conveyor section. [Figure 9] FIG. 2 is a perspective view of an input part constituting the supply unit, showing a state in which a QC sample container is set in the input port. [Figure 10] FIG. 13 is a perspective view of the input section, showing the state in which the QC sample container has been transported into the storage and adjustment unit. [Figure 11] FIG. 2 is a perspective view of a cooling section constituting the supply unit, showing a state in which the cover is closed. [Figure 12] FIG. 4 is a perspective view of the cooling unit with the cover open; [Figure 13] FIG. 2 is a perspective view showing the internal structure of the supply unit. [Figure 14] FIG. 2 is a perspective view showing the internal structure of the supply unit, in which the rack housing section is seen from the front side. [Figure 15] FIG. 2 is a perspective view showing the internal structure of the supply unit, in which the rack housing section is seen from the rear side. [Figure 16] FIG. 2 is a diagram showing a schematic configuration (internal layout) of a supply unit according to an embodiment, illustrating how a QC sample rack is supplied. [Figure 17]FIG. 2 is a diagram showing a schematic configuration (internal layout) of a supply unit according to an embodiment, illustrating how a QC sample rack is being collected. [Figure 18] 13 is an example of a home screen displayed on a monitor of a supply unit. [Figure 19] 13 is an example of a device status screen that is displayed when a device status icon on the home screen is pressed. [Figure 20] 13 is an example of a shutdown screen that is displayed when a shutdown icon on the device status screen is pressed. [Figure 21] 13 is an example of a QC sample removal screen that is displayed when the removal icon on the device status screen is pressed. [Figure 22] 13 is an example of an input screen that is displayed when an input icon on the device status screen is pressed. [Figure 23] 13 is an example of a schedule screen that is displayed when a schedule icon on the home screen is pressed. [Figure 24] 13 is an example of a schedule registration screen that is displayed when a registration icon on the schedule screen is pressed. [Diagram 25] 13 is an example of a confirmation screen that is displayed when an automatic QC schedule is entered and an OK button is pressed on the schedule registration screen. [Figure 26] 13 is an example of an operation menu that is displayed when a schedule list on a schedule screen is pressed. [Figure 27] 1 is an example of a portal screen including a schedule display area and an inventory display area. [Figure 28] FIG. 2 is a block diagram showing the configuration of a supply unit, and also shows the connection relationship between the supply unit and a measurement unit and a transport controller. [Figure 29] 13 is an example of a database of QC samples stored in the control unit of the supply unit. [Diagram 30] 4 is a flowchart showing a series of processes in the sample analysis system. [Diagram 31]13 is a flowchart showing a procedure for automatic wake-up. [Diagram 32] 13 is a flowchart showing a procedure for automatic QC in the supply unit. [Diagram 33] 13 is a flowchart showing a processing procedure for determining a combination of QC sample containers to be used for quality control measurements in automatic QC. [Diagram 34] 10 is a flowchart showing a procedure for automatic cleaning in the supply unit. [Diagram 35] 13 is a flowchart showing the procedure of a process for storing a QC sample container in a cooling section of a supply unit. [Diagram 36] 13 is a flowchart showing the procedure of a process for removing a QC sample container from a cooling section of a supply unit. [Figure 37] 10 is a flowchart showing a measurement procedure for a sample container in the measurement unit. [Figure 38] 13 is a flowchart showing a measurement procedure for a QC sample container in the measurement unit. [Figure 39] 10 is a flowchart showing the procedure of a cleaning process using a cleaning agent container in the measurement unit. [Diagram 40] 13 is a flowchart showing a procedure for transporting and storing racks. [Diagram 41] 13 is a flowchart showing a processing procedure for collecting racks. [Diagram 42] FIG. 13 is a diagram showing the operation of a supply unit in automatic QC. [Diagram 43] 11A and 11B are diagrams illustrating the operation of a supply unit in automatic cleaning. [Diagram 44] 13 is a diagram showing the operation of the supply unit when storing a QC sample container in the cooling section. FIG. [Diagram 45] 13A and 13B are diagrams illustrating the operation of the supply unit when an empty rack is accommodated in the rack accommodation section. [Diagram 46] FIG. 13 shows a specific example of a combination of QC sample containers. [Figure 47] FIG. 13 shows a specific example of a combination of QC sample containers. [Figure 48]FIG. 13 shows a specific example of a combination of QC sample containers. [Figure 49] 13 is an example of a screen for comparing quality control results of an old lot and a new lot, which is displayed on the monitor of the sample analysis system. [Figure 50] 13 is a flowchart illustrating a process of the supply unit when a shutdown instruction is received. [Figure 51] FIG. 2 is a diagram illustrating a schematic configuration of a first modified example of a sample analysis system. [Figure 52] FIG. 13 is a diagram illustrating a schematic configuration of a second modified example of the sample analysis system. [Figure 53] FIG. 13 is a perspective view showing the appearance of a first modified example of the supply unit. [Figure 54] FIG. 13 is a diagram illustrating a schematic configuration of a first modified example of a supply unit. [Figure 55] FIG. 13 is a diagram illustrating a schematic configuration of a second modified example of the supply unit. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0013] Hereinafter, an example of an embodiment of a method for controlling a sample analysis system and a sample analysis system according to the present invention will be described in detail with reference to the drawings. The embodiment described below is merely an example, and the present invention is not limited to the following embodiment. In addition, selective combinations of the components of the multiple embodiments and modified examples described below are included in the scope of the present invention.

[0014] 1 and 2 are diagrams showing a schematic diagram of the overall configuration of a sample analysis system 1 according to an embodiment. As shown in FIG. 1 and FIG. 2, the sample analysis system 1 includes a first measurement unit 10A, a second measurement unit 10B, a transport unit 20, and a control unit 30. The first measurement unit 10A and the second measurement unit 10B are analyzers for analyzing samples containing cells derived from living organisms, and are arranged adjacent to each other. Hereinafter, the two measurement units constituting the analyzer are collectively referred to as a "measurement block." The transport unit 20 is arranged in front of the measurement block. In this specification, for convenience of explanation, terms indicating directions such as front / rear, left / right, and up / down shown in the drawings are used.

[0015] The sample analysis system 1 includes two modules 10, each including a measurement block, a transport unit 20, and a control unit 30. The two modules 10 are arranged next to each other in the left-right direction. The module 10 includes one control unit 30 for two measurement units. The first measurement unit 10A and the second measurement unit 10B are configured as devices for counting blood cells in a blood sample, and have the same hardware configuration. Whole blood is used as the blood sample.

[0016] The sample analysis system 1 includes a supply unit 80 on which a sample rack 110 is set, located upstream of the two modules 10. The sample rack 110 accommodates a plurality of sample containers 100. The sample containers 100 are containers containing blood samples for blood cell measurement, i.e., whole blood. The supply unit 80 is disposed adjacent to one of the two modules 10 that is disposed upstream. The supply unit 80 includes a conveyor section 81 for transporting the sample rack 110 to the module 10. In this embodiment, the sample rack 110 is set on the conveyor section 81 by a user.

[0017] The conveyor section 81 is connected to the transport unit 20 of the module 10, and is configured to be able to deliver the set sample rack 110 to the transport unit 20. In addition to the sample container 100, the supply unit 80 is set with a QC sample container 150 containing a quality control material containing cells of a known concentration, as will be described in detail later. The supply unit 80 includes a storage adjustment unit 82 that cools and stores the QC sample container 150 and adjusts the temperature of the quality control material to a measurement temperature before sending it to the conveyor section 81. The QC sample container 150 contains an amount of quality control material that can be used for multiple measurements. For example, one QC sample container 150 contains an amount of quality control material that can be used for 24 measurements by the measurement unit. In the following, the amount corresponding to one measurement is also referred to as "one test."

[0018] The upstream side of the sample analysis system 1 refers to the side where the sample rack 110 is set and the transport starting point, i.e., the side where the supply unit 80 is located. Additionally, the downstream side of the sample analysis system 1 refers to the side where the transport of the sample rack 110 ends. In Figures 1 and 2, the right side of the page is the upstream side of the sample analysis system 1, and the left side of the page is the downstream side of the sample analysis system 1. The sample rack 110 set in the supply unit 80 is sent to the transport unit 20, and is handed over to the measurement unit by the function of the transport unit 20.

[0019] The transport unit 20 includes a plurality of rack transport paths, and is capable of allocating and supplying the sample containers 100 to the first measurement unit 10A and the second measurement unit 10B. The transport unit 20 includes a first transport path 21 for receiving the sample rack 110 from the upstream side (right side) of the sample analysis system 1 and transporting it to the downstream side (left side), and a second transport path 22 that extends parallel to the first transport path 21 and is disposed closer to the measurement block side than the first transport path 21. The second transport path 22 transports the sample rack 110 in the left-right direction. The second transport path 22 includes a take-out position P2 (see FIG. 5, etc., described later) where the sample container 100 is taken out of the sample rack 110 and taken into the measurement unit.

[0020] The transport unit 20 further includes a third transport path 23. The third transport path 23 extends parallel to the first transport path 21, and is disposed in front of the first transport path 21 in the sample analysis system 1. That is, the transport unit 20 is provided with three rack transport paths aligned in the front-rear direction, in the order of the third transport path 23, the first transport path 21, and the second transport path 22 from the front. As will be described in detail later, the third transport path 23 is configured to transport racks from the downstream side to the upstream side of the sample analysis system 1. For this reason, when the third transport path 23 is viewed alone, the left side is the upstream side of the transport path, and the right side is the downstream side of the transport path.

[0021] The sample analysis system 1 further includes a processing unit 40, a transport unit 50, and a collection unit 60. The processing unit 40 is a device that prepares a smear of a blood sample. The collection unit 60 is a device that collects used sample containers 100 (sample racks 110). The processing unit 40 is disposed adjacent to one of the two modules 10 that is disposed downstream, and the collection unit 60 is disposed adjacent to the processing unit 40 downstream of the sample analysis system 1.

[0022] The transport unit 50 includes a rack transport path for transporting the sample rack 110 to the processing unit 40, and is disposed in front of the processing unit 40. The transport unit 50 is also connected to the transport unit 20 and the collection unit 60 of the module 10. When the sample rack 110 does not include a sample container 100 for which a smear sample needs to be prepared, the sample rack 110 is transported from the transport unit 50 to the collection unit 60 through the processing unit 40.

[0023] In the sample analysis system 1, the units for transporting samples are arranged in the following order from the upstream side: a supply unit 80, transport units 20 corresponding to the upstream and downstream modules 10, a transport unit 50 arranged in front of the processing unit 40, and a recovery unit 60, with adjacent units being connected to each other. In the sample analysis system 1, a continuous rack transport path is formed that can transport a sample rack 110 in the left-right direction from the supply unit 80 to the recovery unit 60. In the example shown in Figures 1 and 2, adjacent units are directly connected to each other, but other transport paths or other units may be interposed between these units.

[0024] In the sample analysis system 1, the measurement block and the transport unit 20 are placed on a wagon 18. The wagon 18 stores a reagent container 19 containing a reagent used in the measurement unit. Similarly, a wagon 90 is provided for the processing unit 40, the transport unit 50, the recovery unit 60, and the supply unit 80. It is preferable that the wagons 18, 51, 61, and 90 have the same height or can be adjusted to the same height so that the rack transport path is along a horizontal plane. Note that the wagon 51 on which the processing unit 40 and the transport unit 50 are placed also stores a reagent container 52 containing a reagent such as a staining solution.

[0025] The sample analyzing system 1 further includes a transport controller 70 for managing the transport of the sample rack 110 and the QC sample rack 160. The transport controller 70 is housed in a wagon 90 below the supply unit 80. The transport controller 70 controls rack transport on the rack transport path of each unit by transmitting and receiving signals to and from the transport units 20, 50, 81, the recovery unit 60, and the supply unit 80. In the sample analyzing system 1, each unit and the transport controller 70 are communicatively connected to a host computer 120 via a communication network.

[0026] The sample analysis system 1 is installed, for example, in a hospital laboratory. In this case, an example of the host computer 120 is a laboratory information system (LIS) that is connected to multiple testing devices and centrally manages sample information and measurement orders. Information about each sample container 100 and each QC sample container 150 is registered in the host computer 120.

[0027] In this specification, a rack that does not accommodate a container is referred to as an empty rack 170 (see FIG. 8 etc. described later). An empty rack 170 that accommodates a sample container 100 is referred to as a sample rack 110. An empty rack 170 that accommodates a QC sample container 150 is referred to as a QC sample rack 160.

[0028] In the sample analysis system 1, a sample rack 110 set in a supply unit 80 is transported to the first transport path 21 of an adjacent transport unit 20. If the destination of the sample rack 110 is not the upstream module 10, the sample rack 110 transported to the first transport path 21 is transported to the transport unit 20 of the downstream module 10 by the first transport path 21. If the destination is the upstream module 10, the sample rack 110 is transported from the first transport path 21 to the second transport path 22 of this module 10, where an initial test and, if necessary, a retest are performed in the measurement block of this module 10. The control unit 30 is configured to transmit the results of the initial test and the retest to the host computer 120.

[0029] When the initial test and necessary retest are completed for all the sample containers 100 contained in the sample rack 110, the transport controller 70 inquires of the host computer 120 as to whether or not a smear needs to be prepared for each sample container 100 in the processing unit 40. If the sample rack 110 includes a sample container 100 for which a smear needs to be prepared, the destination of this sample rack 110 is the processing unit 40, and this sample rack 110 is supplied to the processing unit 40 via the transport path of the transport units 20 and 50.

[0030] When the sample rack 110 does not include a sample container 100 for which a smear sample needs to be prepared, the destination of the sample rack 110 is the collection unit 60, and the sample rack 110 is transported to the collection unit 60 via the transport paths of the transport units 20 and 50. Even when a smear sample is prepared in the processing unit 40, the sample rack 110 is transported to the collection unit 60 after the smear sample is prepared.

[0031] Fig. 3 is a block diagram showing the connection relationships of the units constituting the sample analysis system 1. As shown in Figs. 1 to 3, the control unit 30 is communicably connected to the measurement units in the same module 10 and controls the measurement units in the same module 10. The control unit 30 controls, for example, the first measurement unit 10A and the second measurement unit 10B, and also controls a part of the transport unit 20. The control unit 30 is configured to receive sample measurement data from the first measurement unit 10A and the second measurement unit 10B, and generate sample measurement results according to the measurement items.

[0032] The transport unit 20 includes a first transport mechanism 20a whose transport operation is controlled by a transport controller 70, and a second transport mechanism 20b whose transport operation is controlled by a control unit 30. The first transport mechanism 20a includes a portion related to rack transport on the first transport path 21 and the third transport path 23. The second transport mechanism 20b includes a portion related to rack transport by the second transport path 22, the first storage section 24, and the second storage section 25 (see FIG. 5). The control unit 30 is connected to the first measurement unit 10A, the second measurement unit 10B, the first transport mechanism 20a, and the second transport mechanism 20b so as to be able to communicate with them.

[0033] The control unit 30 is, for example, a personal computer. The control unit 30 includes a control unit 31. The control unit 31 mainly includes a processor, a storage unit, and an input / output interface. The processor is, for example, a CPU, and controls the operation of each part of the measurement unit and the transport unit by reading and executing a control program installed in the storage unit. The processor further executes an analysis program installed in the storage unit to analyze the measurement data transmitted from the measurement unit and count or quantify blood components such as red blood cells, white blood cells, platelets, and hemoglobin contained in the sample. The storage unit includes a non-volatile memory such as a ROM, HDD, or SSD, and a volatile memory such as a RAM. The control unit 30 is connected to the measurement unit and the transport unit by a LAN cable.

[0034] Each unit constituting the sample analysis system 1 is communicatively connected via a concentrator 130. The concentrator 130 is, for example, configured by a hub. In this embodiment, the first transport mechanism 20a, the transport unit 50, the recovery unit 60, the transport controller 70, and the supply unit 80 of the two modules 10 are communicatively connected via the concentrator 130. As described above, each unit and the transport controller 70 are communicatively connected to the host computer 120. The control unit 30 (control unit 31), for example, queries the host computer 120 about a measurement order to acquire the measurement order, and controls the measurement unit based on the acquired measurement order.

[0035] The processing unit 40 includes a control unit 41 and a preparation unit 42. The control unit 41 includes, for example, a processor and a storage unit incorporated in the processing unit 40, and controls the preparation unit 42 based on a control program installed in the storage unit. When the specimen container 100 from which a smear sample is to be prepared is transported to a predetermined position on the rack transport path of the transport unit 50, the preparation unit 42 is configured to aspirate the specimen from the specimen container 100 and prepare a smear sample. The operation of the preparation unit 42 is controlled by the control unit 41. The collection unit 60 collects the specimen rack 110 for which measurement has been completed in either of the two modules 10, and the specimen rack 110 for which preparation of a smear sample has been completed via the processing unit 40. The collection unit 60 includes a rack transport path, and is controlled by a transport controller 70.

[0036] The transport controller 70 is, for example, a personal computer. The transport controller 70 includes a control unit 71. The hardware configuration of the control unit 71 is similar to that of the control unit 31 of the control unit 30. The control unit 71 transmits control signals to the supply unit 80, the first transport mechanism 20a, the transport unit 50, and the recovery unit 60 via the concentrator 130 to control the transport of the sample rack 110 and the QC sample rack 160. The control unit 71 is communicatively connected to the control unit 30. The control unit 71 grasps the positions of each sample rack 110 and each QC sample rack 160 on the transport path based on the detection signals of the sensors of each unit.

[0037] The control unit 82a of the supply unit 80 mainly controls the operation of each component of the storage adjustment unit 82. In this embodiment, the function of the control unit 82a also executes automatic wake-up and automatic shutdown of each unit of the sample analysis system 1. The hardware configuration of the control unit 82a is similar to that of the control units 31 and 71.

[0038] 4 is a perspective view showing a sample rack 110 housing a plurality of sample containers 100. For ease of explanation, in this specification, when the sample rack 110 is set in the sample analysis system 1, the side facing the front of the system is referred to as the front side of the sample rack 110, and the side facing the rear of the system is referred to as the rear side of the sample rack 110.

[0039] As shown in FIG. 4, the specimen container 100 comprises a bottomed tube 101 containing a blood specimen collected from a subject, and a cap 102 that closes the opening of the tube 101. The tube 101 is a bottomed cylindrical container made of, for example, translucent glass or resin. The opening of the tube 101 is closed with a rubber cap 102, and the internal space that contains the specimen is sealed. The specimen container 100 is also provided with a machine-readable label 103. The machine-readable label 103 is, for example, a barcode label on which a barcode indicating the specimen ID is printed, and is attached to the side surface of the tube 101. The specimen ID is identification information that can individually identify a specimen.

[0040] The sample rack 110 (empty rack 170) is a case that contains the sample containers 100 and is used for transporting the sample containers 100, and includes a number of storage sections 111 that can hold a number of sample containers 100 in an upright state. The number of storage sections 111 is not particularly limited, but in this embodiment, ten storage sections 111 (numbers 1 to 10) are formed in a line in the left-right direction. The sample rack 110 is also provided with a machine-readable label 112. The machine-readable label 112 is, for example, a barcode label on which a barcode indicating a rack ID is printed. The rack ID is identification information that can individually identify the sample rack 110.

[0041] The sample rack 110 includes a bottom plate 113 having a rectangular shape when viewed from the bottom, and a wall 114 extending in the height direction of the sample container 100 and supporting the sample container 100. In the sample rack 110, the sample container 100 stands upright substantially perpendicular to the bottom plate 113. The wall 114 is formed at a height lower than the upright sample container 100. The wall 114 includes a pair of side walls 115 formed at both left and right ends of the bottom plate 113, a front wall 116 formed along the front end of the bottom plate 113 and connecting the two side walls 115, and a plurality of partitions 117 extending from the front wall 116 to the rear end side of the bottom plate 113. The plurality of partitions 117 divide the storage space for the sample container 100, forming a plurality of storage sections 111 (ten in FIG. 4).

[0042] The rack illustrated in Fig. 4 has nine partitions 117, and a machine-readable label 112, which is a barcode label, is attached to the rear surface of the partition 117 that separates the first and second storage sections 111. Each storage section 111 has a large opening toward the top and rear. Therefore, even when the sample container 100 is stored in the storage section 111, the machine-readable label 103 can be read. Note that the machine-readable labels 103 and 112 are not limited to one-dimensional barcode labels as shown in Fig. 4, and may be two-dimensional codes. The machine-readable labels 103 and 112 may be IC tags that can be read by an RFID reader.

[0043] Hereinafter, the configuration of the measurement block and the transport unit 20 will be described in detail with reference to Fig. 5 and Fig. 6. In Fig. 5, the plate 272 of the first sending section 27A is in a position retracted from the first transport path 21, and in Fig. 6, the plate 272 is present on the first transport path 21.

[0044] [Measurement block (first measurement unit 10A, second measurement unit 10B)] As shown in Figures 5 and 6, the first measurement unit 10A and the second measurement unit 10B are disposed adjacent to the transport unit 20 in the front-rear direction and at the rear of the transport unit 20. The first measurement unit 10A and the second measurement unit 10B take out the sample container 100 from the sample rack 110 transported to the second transport path 22 of the transport unit 20 and measure the blood sample contained in the sample container 100. Although Figures 5 and 6 show the configuration of the first measurement unit 10A, the second measurement unit 10B also has the same device structure.

[0045] The first measurement unit 10A can measure, for example, CBC items and DIFF items. The CBC items include WBC (white blood cell count), RBC (red blood cell count), HGB (hemoglobin), HCT (hematocrit), MCV (mean corpuscular volume), MCH (mean corpuscular hemoglobin), MCHC (mean corpuscular hemoglobin concentration), PLT (platelet count), etc. The DIFF items include NEUT# (neutrophil count), LYMPH# (lymphocyte count), MONO# (monocyte count), EO# (eosinophil count), BASO# (basophil count), etc. The second measurement unit 10B can measure, for example, RET items, PLT-F items, and WPC items in addition to the CBC items and DIFF items. The RET items include RET# (reticulocyte count), etc. The PLT-F items include, for example, PLT# (platelet count). The WPC section detects and flags abnormal white blood cells, for example blasts and lymphocytes.

[0046] In one embodiment, the first measurement unit 10A measures the CBC and DIFF items as an initial test. The second measurement unit 10B measures the CBC and DIFF items as an initial test, and measures the RET, PLT-F, or WPC items as a retest as necessary. That is, the first measurement unit 10A is a measurement unit dedicated to the initial test, and the second measurement unit 10B is a measurement unit capable of performing retests in addition to the initial test.

[0047] The first measurement unit 10A includes a container transport section 11, an information reading section 12, a sample preparation section 13, and a measurement section 14. The first measurement unit 10A includes a robot hand 15 that takes out a sample container 100 from a storage section 111 of a sample rack 110 at a predetermined take-out position P2 of the second transport path 22, shakes the taken-out sample container 100 a predetermined number of times to invert and mix it, and places the mixed sample container 100 in the container transport section 11. The container transport section 11 has a holder 11a that can hold the sample container 100 in an upright state, and is configured so that the holder 11a moves in the front-rear direction together with the container transport section 11. The information reading unit 12 is positioned at a position on the transport path of the sample container 100 by the container transport unit 11, between the installation position where the sample container 100 is installed by the robot hand 15 and the suction position by the suction tube 13a described below, and reads the sample ID from the machine-readable label 103 of the sample container 100 set in the holder 11a.

[0048] The sample preparation unit 13 includes an aspirating tube 13a. The sample preparation unit 13 pierces the cap 102 of the sample container 100 set in the holder 11a with the aspirating tube 13a, and aspirates the sample through the aspirating tube 13a. The sample preparation unit 13 includes, for example, a reaction vessel, and prepares a measurement sample by mixing the aspirated sample and a reagent in the reaction vessel. The reagent is, for example, a diluent, a hemolytic agent, and a staining solution. The measurement unit 14 includes, for example, an optical detection unit, an electrical resistance detection unit, and a hemoglobin measurement unit, and performs measurement of the measurement sample. When the aspirating of the sample is completed, the sample container 100 is transported forward by the container transfer unit 11, and is returned to the original storage unit 111 of the sample rack 110 by the robot hand 15.

[0049] The first measurement unit 10A, the second measurement unit 10B, and the second transport mechanism 20b (see FIG. 3), which is a part of the transport unit 20, are controlled by the control unit 30. When performing a first test, the control unit 30 inquires of the host computer 120 about a measurement order for the first test based on the read sample ID, and acquires the sample measurement order from the host computer 120. The control unit 30 stores retest rules for deciding whether or not to perform a retest based on the measurement results of the first test, and generates a measurement order for the retest when it is decided to perform a retest according to the rules.

[0050] During an initial test, the multiple sample containers 100 stored in the sample rack 110 are sequentially loaded into the first measurement unit 10A or the second measurement unit 10B from the leftmost storage section 111 to the rightmost storage section 111, and the samples are measured. At this time, the measurement unit that loads the sample containers 100 is determined so that the load on the measurement units is distributed. For example, the sample containers 100 with odd storage position numbers shown in Fig. 4 are loaded into the second measurement unit 10B, and the sample containers 100 with even storage position numbers are loaded into the first measurement unit 10A.

[0051] [Transport unit 20] As described above, the transport unit 20 includes the first transport path 21, the second transport path 22, and the third transport path 23. The three transport paths extend in the left-right direction and are arranged parallel to one another. The first transport path 21 transports the sample rack 110 from the upstream side to the downstream side (from right to left) of the sample analysis system 1. The second transport path 22 can transport the sample rack 110 both left-right, that is, from right to left and left-right.

[0052] The third transport path 23 transports the QC sample rack 160 from the downstream side to the upstream side (from left to right) of the sample analysis system 1. The QC sample container 150 contains a quality control substance to be used for multiple measurements, and since the quality control substance needs to be stored in a refrigerated state in the supply unit 80, it is returned to the supply unit 80 after the measurement in the measurement unit is completed. In this embodiment, since the used sample rack 110 is transported to the collection unit 60, the third transport path 23 does not transport the sample rack 110.

[0053] The transport unit 20 is provided with movable stoppers 21c, 23b at the downstream end of the first transport path 21 and the downstream end of the third transport path 23. In addition, a movable stopper 21d is provided between the first transport path 21 and the third transport path 23 at a position aligned in the front-rear direction with a second reservoir 25 described below. Below, the configuration of the transport unit 20 will be described taking the sample rack 110 as an example, with regard to the contents common to the transport of the sample rack 110 and the QC sample rack 160.

[0054] The first transport path 21, the second transport path 22, and the third transport path 23 are disposed apart in the front-rear direction. A first storage section 24 and a second storage section 25, which are spaces capable of storing the sample racks 110, are provided between the first transport path 21 and the second transport path 22. The right end of the second transport path 22 is connected to the upstream end of the first transport path 21 via the first storage section 24, and the left end of the second transport path 22 is connected to the downstream end of the first transport path 21 via the second storage section 25.

[0055] The transport unit 20 further includes a plurality of rack output units for transferring the sample rack 110 between the transport paths and between the transport paths and the storage units, and a plurality of sensors for detecting the position of the sample rack 110 in the transport paths and the storage units. The transport unit 20 includes an information reading unit 26 for reading the sample ID and the rack ID from the machine-readable label 103 of the sample container 100 and the machine-readable label 112 of the sample rack 110, respectively. The information reading unit 26 is disposed in the center of the length of the second transport path 22, and is disposed between the right-side take-out position P2 corresponding to the first measurement unit 10A and the left-side take-out position P2 corresponding to the second measurement unit 10B so as to be able to read the above-mentioned machine-readable labels 103 and 112.

[0056] The transport unit 20 includes a first sender 27A, a second sender 27B, a third sender 27C, and a fourth sender 27D as rack senders. All four rack senders are rack transport devices configured to be movable in the front-rear direction. The first sender 27A is configured to push the sample rack 110 from an upstream position of the first transport path 21 to the first storage section 24. The second sender 27B transports the sample rack 110 from the first storage section 24 to the right end position of the second transport path 22, and the third sender 27C transports the sample rack 110 from the left end position of the second transport path 22 to the second storage section 25. The fourth sender 27D transports the sample rack 110 from the second storage section 25 to a downstream position of the first transport path 21.

[0057] The transport unit 20 includes four sensors 28a, 28b, 28c, and 28d for detecting the sample racks 110 on the first transport path 21 and the second transport path 22. In addition, the transport unit 20 includes sensors 28e and 28f for detecting the sample racks 110 on the third transport path 23. The transport unit 20 includes sensors 28g, 28h, and 28i for detecting the sample racks 110 in the first storage section 24 and the second storage section 25.

[0058] Hereinafter, each component of the transport unit 20 will be described along the transport path of the sample rack 110. Note that, of the two modules 10, the module 10 arranged on the upstream side of the sample analysis system 1 will be described as an example in Figures 5 and 6.

[0059] The first transport path 21 includes transport belts 21a and 21b for transporting the sample rack 110 carried in from the supply unit 80 to the downstream module 10. The transport belts 21a and 21b are driven independently by corresponding stepping motors. That is, the first transport path 21 includes two conveyor belts. The transport belt 21b is provided from a position in front of the second storage section 25 to the downstream end of the first transport path 21. The transport belt 21a is provided from the upstream end of the first transport path 21 to the vicinity of the transport belt 21b.

[0060] The transport of the sample rack 110 in the first transport path 21 is performed under the control of the transport controller 70. Specifically, the transport controller 70 transmits a control signal to a stepping motor connected to the transport belts 21a and 21b, and the motor is driven based on the control signal. Note that the transport of the sample rack 110 in the other transport paths and rack output units is also performed under the control of the transport controller 70 or the control unit 30.

[0061] The sample rack 110, which is transported from the supply unit 80 to an upstream position of the first transport path 21, is transported downstream by the transport belt 21a. The sample rack 110 is detected by the sensor 28a and sent to the first storage section 24 by the first sending section 27A. The sensor 28a is, for example, an optical sensor having a light emitting section and a light receiving section, and is arranged so that the light emitting section and the light receiving section sandwich the first transport path 21 from the front and rear. The sensor 28a detects the sample rack 110 when the light emitted from the light emitting section is blocked by the sample rack 110 and the light receiving level of the light receiving section drops. Note that an optical sensor similar to the sensor 28a can be applied to other sensors installed in the transport unit 20.

[0062] The first sending section 27A provided at an upstream position of the first transport path 21 has a plate 271 along the length direction of the first transport path 21 and a plate 272 along the width direction of the first transport path 21 as engagement sections that engage with the sample rack 110. The plates 271, 272 are, for example, connected to each other and arranged in a generally L-shape in plan view. The first sending section 27A is configured to be movable in the front-rear direction between a retracted position (see FIG. 5) where the plates 271, 272 do not interfere with the transport of the sample rack 110 by the first transport path 21, a stop position (see FIG. 6) where the sample rack 110 being transported by the first transport path 21 is stopped, and a position where the sample rack 110 is pushed out to the first storage section 24.

[0063] 6, when the first sender 27A is in the stopped position, only the plate 272 is disposed on the first transport path 21. The sample rack 110 transported by the transport belt 21a is caught by the plate 272 and stops. From this state, the first sender 27A (plate 271) moves backward, pushing the sample rack 110 into the first storage section 24. The sample rack 110 transported to the first storage section 24 is detected by sensors 28g disposed to sandwich the first storage section 24 from the left and right.

[0064] The first storage section 24 is a space for storing the sample rack 110 received from the first transport path 21, and is configured, for example, by arranging a plate-like member whose upper surface is parallel to a horizontal plane between the first transport path 21 and the second transport path 22. The sample rack 110 sent to the first storage section 24 is detected by a sensor 28g, and is sent to the second transport path 22 at an appropriate timing by the second sender 27B. The second sender 27B has, for example, an engagement section that abuts against the front surface of the sample rack 110, and pushes both left and right ends of the front surface of the sample rack 110 backward to push the sample rack 110 to the right end position of the second transport path 22. A sensor 28c is installed near the right end position of the second transport path 22, and the sample rack 110 transported to the right end position is detected by the sensor 28c.

[0065] The second transport path 22 includes two transport belts 22a and 22b that transport the sample rack 110 in the left-right direction independently. The transport belts 22a and 22b are driven independently by corresponding stepping motors. The transport belts 22a and 22b are arranged side by side in the front-rear direction and extend in the left-right direction from the right end position to the left end position of the second transport path 22. The transport belt 22a is provided with two protrusions 22c between which the sample rack 110 fits. Similarly, the transport belt 22b is provided with two protrusions 22d between which the sample rack 110 fits. The sample rack 110 is sent to the second sending section 27B so as to fit between these protrusions 22c. The sample rack 110 is transported in the left-right direction by driving the transport belts 22a and 22b while being fitted between the protrusions 22c.

[0066] According to the second transport path 22, two sample racks 110 can be transported separately in the left-right direction. As shown in Fig. 6, two sample racks 110 can be simultaneously loaded into the second transport path 22. Hereinafter, the sample rack 110 that is sent first into the second transport path 22 will be referred to as the "leading rack", and the sample rack 110 that is sent into the second transport path 22 after the leading rack will be referred to as the "following rack". In this case, while samples are being measured for the leading rack, measurements can also be performed in parallel for the following rack.

[0067] The information reading unit 26 includes rollers 26a, 26b, and a reading unit 26c arranged to sandwich the second transport path 22. The rollers 26a, 26b can move toward each other, and the roller 26a rotates while sandwiching the sample container 100 in the front-rear direction. This rotates the sample container 100. The reading unit 26c reads the machine-readable label 103 of the rotating sample container 100 through the gap of the roller 26b. The reading unit 26c can also read the rack ID of the sample rack 110. The reading unit 26c is, for example, a barcode reader. Reading of the sample ID and rack ID by the information reading unit 26 and measurement of the sample by the measurement unit are performed under the control of the control unit 30.

[0068] The sample container 100 whose sample ID has been read is transported to a take-out position P2 corresponding to either the first measurement unit 10A or the second measurement unit 10B, and is taken out of the sample rack 110 by the robot hand 15 and taken into the measurement unit. At this time, the measurement unit that takes in the sample container 100 is determined so that the load on each measurement unit is distributed. A first test is performed in the measurement unit, and when the first test is completed, the sample container 100 is returned to the original storage section 111 at the take-out position P2. When the first test and necessary retests are all completed for all the sample containers 100 stored in the sample rack 110, the sample rack 110 is transported to the downstream end of the second transport path, i.e., to the rear of the second storage section 25, and is transported to the second storage section 25 by the third sending section 27C.

[0069] Even if the initial inspection of all the sample containers 100 in the leading rack is completed, the leading rack needs to remain on the second transport path 22 until it is determined whether or not all the sample containers 100 need to be retested. At this time, since it takes a certain amount of time to determine whether or not the sample container 100 that was last subjected to the initial inspection needs to be retested, in order to improve the measurement efficiency, the following rack is sent to the second transport path 22 and the initial inspection of the following rack is started. The waiting leading rack is retreated to the left end position of the second transport path 22 so as not to interfere with the transport of the following rack.

[0070] A sensor 28d is provided near the left end position of the second transport path 22. The sample rack 110 for which the initial test and all necessary retests have been completed is pushed from the left end position to the second storage section 25 provided in front of it by the third sending section 27C. The second storage section 25 is a space for storing the sample rack 110 received from the second transport path 22, and is configured by arranging plate-like members whose upper surface is parallel to the horizontal plane, similar to the first storage section 24. The sample rack 110 in the second storage section 25 is detected by the sensors 28h and 28i, and is pushed to the first transport path 21 at an appropriate timing by the fourth sending section 27D.

[0071] The rack in the second storage unit is transported to the first transport path 21 or the third transport path depending on the next transport destination determined by the transport controller 70.

[0072] For example, if the rack in the second storage section is a sample rack 110 containing a sample container 100 and the next destination is the processing unit 40 or the recovery unit 60, the sample rack 110 needs to be transported leftward and is sent to the first transport path 21. For example, if the rack in the second storage section is a QC sample rack 160 containing a QC sample container 150 and the next destination is the adjacent measurement block, the QC sample rack 160 needs to be transported leftward and is sent to the first transport path 21. If the next destination is the supply unit 80, the QC sample rack needs to be transported rightward and is sent to the third transport path.

[0073] When a rack in the second storage unit 25 is transported to the first transport path 21, the fourth sending unit 27D pushes the rack forward with the stopper 21d raised to a position higher than the belt of the first transport path 21. The rack pushed forward hits the stopper 21d and stops at a downstream position of the first transport path 21. When the transport belt 21b is driven with the stopper 21c lowered, the rack is transported to the left.

[0074] When a rack in the second storage unit 25 is transported to the third transport path 23, the fourth sending unit 27D pushes the rack forward when the stopper 21d is lowered to a position equal to or lower than the height of the belt of the first transport path 21. The rack pushed forward passes over the stopper 21d and is sent to an upstream position of the third transport path 23.

[0075] The third transport path 23 includes a transport belt 23a. The transport belt 23a is driven by a stepping motor, similar to the above-mentioned transport belts 21a and 21b. The rack transported to the third transport path 23 is transported to the right by the transport belt 23a.

[0076] [Supply Unit 80] Hereinafter, the configuration of the supply unit 80 will be described in detail with reference to FIGS.

[0077] As described above, the supply unit 80 is a device for supplying the sample rack 110 containing the sample container 100 to the measurement unit. The supply unit 80 further cools and stores the QC sample container 150 containing the quality control material, and adjusts the temperature of the quality control material to a measurement temperature according to a schedule previously registered by the user. After that, the QC sample container 150 containing the temperature-adjusted quality control material is set in a rack and transported toward the target measurement unit. The QC sample container 150 is accommodated in an empty rack 170, and is transported to the second transport path 22 of the transport unit 20 as a QC sample rack 160 containing the QC sample container 150, similar to the sample rack 110.

[0078] The QC specimen container 150 differs from the specimen container 100 in that it contains a quality control material containing cells of a known concentration. Like the specimen container 100, the QC specimen container 150 includes a tube 101 and a cap 102. A machine-readable label 103 indicating a specimen ID including the lot number, concentration level, and expiration date of the QC specimen is attached to the side of the tube 101. The machine-readable label 103 is a barcode label. Note that a container having a different shape from the specimen container 100 may be used for the QC specimen container 150, and two or more types of containers may be used for each of the specimen container 100 and the QC specimen container 150.

[0079] The quality control material is generally also called a control sample or a QC sample. In the sample analysis system 1, it is necessary to periodically check that there is no abnormality in the measurement results of the analyzer using the quality control material, and to manage the measurement quality. For example, once a day before starting the measurement of the sample, the sample analysis system 1 transports the QC sample container 150 to the first measurement unit 10A and the second measurement unit 10B, which are the analyzers, and measures the quality control material. The measurement value of the quality control material, such as the red blood cell count, the white blood cell count, the platelet count, the hemoglobin concentration, etc., is compared with, for example, the upper limit and the lower limit stored in advance in the control unit 31 of the control unit 30. If the measurement value of the quality control material is within the upper limit and the lower limit, the quality control result is judged to be normal, and if it is outside the range, it is judged to be abnormal.

[0080] The quality control substance is a control blood suitable for quality control of an automated blood cell counter, and contains whole blood components adjusted to known concentrations. The whole blood components are, for example, blood cells, including red blood cells, white blood cells, and platelets. An example of such a quality control substance is XN-CHECK (manufactured by Sysmex Corporation). The quality control substance may contain three types of quality control substances adjusted to three concentration levels: low concentration, standard concentration, and high concentration. Hereinafter, the low concentration quality control substance will be referred to as level 1, the standard concentration quality control substance as level 2, and the high concentration quality control substance as level 3.

[0081] For example, a plurality of QC sample containers 150 are refrigerated and stored in the supply unit 80. Preferably, the supply unit 80 refrigerates and stores two or more types of containers each containing a plurality of types of quality control substances having different concentration levels.

[0082] 7 is a perspective view showing the appearance of the supply unit 80. The supply unit 80 includes a first transport path 811 (see FIG. 8 described later) of a conveyor section 81 that is accessible from the outside so that a user can set a rack. On the front side of the supply unit 80, a first insertion port 831A into which a QC sample container 150 is set, and a first cover 832A that covers the first insertion port 831A are provided.

[0083] The first cover 832A covers the entire first insertion port 831A and is opened and closed by the user. The left end of the first cover 832A is rotatably supported on the housing, for example, and is configured to rotate leftward to open. When the first cover 832A is opened, a transfer holder 834 (see FIG. 8, etc.) that holds the QC sample container 150 and transfers it to the inside of the supply unit 80 is exposed. The QC sample container 150 is set in the transfer holder 834, which will be described in detail later.

[0084] The supply unit 80 further includes a second input port 831B into which the cleaning agent container 180 (see FIG. 8, etc.) is set, and a second cover 832B that covers the second input port 831B. The second input port 831B is disposed adjacent to the right side of the first input port 831A. The second cover 832B is configured such that, for example, a rear end portion of the second cover 832B is rotatably supported on the housing and rotates upward to open.

[0085] A monitor 91 is provided on the front surface of the supply unit 80. The monitor 91 is a display device for displaying, for example, information on the state of the supply unit 80 including information on the inserted QC sample containers 150, and information necessary for operating the supply unit 80. The monitor 91 is configured with a touch panel that can also be used as an operation unit.

[0086] 8 is a diagram showing a schematic internal layout of the supply unit 80. The supply unit 80 includes, as main components, a conveyor section 81 and a storage adjustment unit 82. The storage adjustment unit 82 includes an input section 83, a cooling section 84, a transport section 85, a heating section 86, an information reading section 87, and a rack housing section 88. In the following explanation, contents common to the transport of the sample rack 110 and the transport of the QC sample rack 160 will be explained by taking the transport of the sample rack 110 as an example.

[0087] [Conveyor section 81] The conveyor section 81 includes a plurality of rack transport paths that transport the sample racks 110 within the supply unit 80. The conveyor section 81 includes, in order from the upstream side, a first transport path 811, a second transport path 812, a third transport path 813, and a fourth transport path 814. These four transport paths are connected, and the sample rack 110 set in the first transport path 811 is sent to the fourth transport path 814 via the second transport path 812 and the third transport path 813. The fourth transport path 814 is connected to the transport unit 20 of the module 10, and the sample rack 110 is transported from the fourth transport path 814 to the first transport path 21 of the transport unit 20.

[0088] The conveyor section 81 further includes a fifth transport path 815 that is connected to the third transport path 23 of the transport unit 20 and receives the QC sample rack 160 that has returned via the third transport path 23 of the adjacent transport unit 20. The fifth transport path 815 is disposed in front of the fourth transport path 814 in the conveyor section 81. The fifth transport path 815 is a rack transport path for returning the QC sample rack 160 to the storage adjustment unit 82, and is connected to the first transport path 811.

[0089] The conveyor section 81 is provided with a sixth transport path 819 between the first transport path 811 and the fifth transport path 815. As shown in FIG. 49 described later, when an additional supply unit is provided, the sixth transport path 819 is used to carry in the sample rack 110 from the additional supply unit. The sixth transport path 819 includes a transport belt 819a that transports the sample rack 110 from right to left. A sensor 819b that detects the sample rack 110 is provided near the left end position of the sixth transport path 819.

[0090] The first transport path 811 and the third transport path 813 are arranged parallel to each other. The first transport path 811 is a transport path for transporting the sample rack 110 from the front to the rear, and the third transport path 813 is a transport path for transporting the sample rack 110 from the rear to the front. The second transport path 812 is provided extending in the left-right direction, and the right end of the second transport path 812 is aligned with the rear end of the first transport path 811, and the left end of the second transport path 812 is aligned with the rear end of the third transport path 813. With this configuration, the second transport path 812 can receive the rack sent out from the first transport path 811 and transport it in the left-right direction. The third transport path 813 can receive the rack transported to the left end by the second transport path 812.

[0091] The first transport path 811 and the third transport path 813 are formed long in the front-rear direction and can store a plurality of sample racks 110 at one time. The first transport path 811 is provided with a stopper 811a for supplying the sample racks 110 one by one to the second transport path 812. The stopper 811a is a movable stopper that moves in the vertical direction, and is disposed at the boundary with the second transport path 812.

[0092] The stopper 811a is provided so as to be rotatable in the front-rear direction, and when it rotates from the rear to the front, it protrudes upward, and when it rotates in the opposite direction, it is stored downward. The stopper 811a is in a state where it does not protrude from the upper surface when the sample rack 110 in the first transport path 811 is transported to the second transport path 812. When the transport of the rack to the second transport path 812 is completed, the stopper 811a rotates forward and is positioned so as to be interposed between the sample rack 110 in the second transport path 812 and the sample rack 110 in the first transport path 811. The stopper 811a enters between the sample rack 110, and the two racks are separated. The third transport path 813 is also provided with a movable stopper 813a similar to the stopper 811a at the boundary with the fourth transport path 814.

[0093] The second transport path 812, the fourth transport path 814, and the fifth transport path 815 extend in the left-right direction and are arranged parallel to each other. The second transport path 812 includes a transport belt 812b capable of transporting the sample rack 110 from right to left and from left to right. The fourth transport path 814 is a transport path for transporting the sample rack 110 to the first transport path 21 of the transport unit 20, and the third transport path 813 is connected to the right end side of the fourth transport path 814. The fifth transport path 815 includes a transport belt 815b capable of transporting the QC sample rack 160 carried in from the third transport path 23 of the transport unit 20 to the right.

[0094] The conveyor unit 81 includes a plurality of rack output units for transferring the sample rack 110 between the transport paths, and a plurality of sensors for detecting the position of the sample rack 110 on the transport path. The conveyor unit 81 also includes a first information reading unit 817A, a second information reading unit 817B, and a third information reading unit 817C.

[0095] The conveyor unit 81 includes a first sender 816A, a second sender 816B, a third sender 816C, a fourth sender 816D, and a fifth sender 816E as rack senders. The first sender 816A includes an engagement unit 816f that contacts the front surface of the sample rack 110 to push the sample rack 110 backward, and a drive mechanism that moves the engagement unit 816f in the front-rear direction along the first transport path 811, and is configured to push the sample rack 110 from the first transport path 811 to the second transport path 812.

[0096] The first sending section 816A includes, as the driving mechanism, a belt 816g arranged along the first transport path 811, a connecting member 816h connecting the engaging portion 816f and the belt 816g, and a motor 816i for driving the belt 816g. For example, a stepping motor is used as the motor 816i. In the first transport path 811, the sample rack 110 pushed by the engaging portion 816f hits the preceding rear sample rack 110 and stops, so the first sending section 816A is provided with a torque sensor 816j capable of detecting this state.

[0097] The first sender 816A is configured to return the engaging portion 816f to the original position shown in Fig. 8 when the torque sensor 816j is actuated. The engaging portion 816f is pivotally supported backwards by the connecting member 816h so that the engaging portion 816f does not push the sample rack 110 forward even if the engaging portion 816f hits the following sample rack 110 when returning to the original position. The third sender 816C has a structure similar to that of the first sender 816A, and is configured to push the sample rack 110 from the third transport path 813 to the fourth transport path 814.

[0098] The second sender 816B transports the sample rack 110 from the second transport path 812 to the third transport path 813, and the fourth sender 816D transports the sample rack 110 from the fourth transport path 814 to the first transport path 21 of the transport unit 20. In addition, the fifth sender 816E transports the QC sample rack 160 from the fifth transport path 815 to the first transport path 811.

[0099] The conveyor unit 81 includes sensors 818a and 818b for detecting the sample rack 110 on the first transport path 811. In addition, the conveyor unit 81 includes sensors 818c and 818e for detecting the sample rack 110 on the second transport path 812, and sensors 818f and 818g for detecting the sample rack 110 on the third transport path 813. In addition, the conveyor unit 81 includes a sensor 818h for detecting the sample rack 110 on the fourth transport path 814, and sensors 818i and 818j for detecting the sample rack 110 on the fifth transport path 815.

[0100] The conveyor unit 81 further includes a sensor 818d that detects a container stored in a rack moving on the second transport path 812. The sensor 818d is provided in the middle of the second transport path 812. The presence or absence of a container in a rack moving on the second transport path 812 can be determined from detection information of the sensor 818d, so that if no container is detected by the sensor 818d, it can be determined that the rack on the second transport path 812 is an empty rack 170. The detection information of the sensor 818d is used to determine the destination of the rack moving on the second transport path 812.

[0101] The sensors 818a, 818c, 818e, 818f, 818i, and 818j are, for example, reflective optical sensors in which the light emitting section and the light receiving section are integrated. The sensors 818b, 818d, 818g, and 818h are, for example, photointerrupter type optical sensors in which the light emitting section and the light receiving section are separated. The fourth transport path 814 is formed with an opening 814d of a size that does not interfere with the transport of the sample rack 110. The light emitting section of the sensor 818h is disposed below this opening 814d, and the light receiving section is disposed near the right end position of the fourth transport path 814.

[0102] When a sample rack 110 is set on the first transport path 811, it is detected by a sensor 818b, and is transported by the first output unit 816A to the right end position of the second transport path 812. The sample rack 110 brought into the right end position of the second transport path 812 is detected by a sensor 818c, and is transported by the transport belt 812b to the left end position of the second transport path 812. As the sample rack 110 moves from right to left on the second transport path 812, a sensor 818d disposed in the middle of the second transport path 812 detects whether or not there is a container accommodated in the rack.

[0103] The sample rack 110 is detected by a sensor 818e at the left end position of the second transport path 812. A first information reading unit 817A and a second information reading unit 817B are provided behind the second transport path 812. The first information reading unit 817A and the second information reading unit 817B are provided so as to be movable in a direction approaching each other, and sequentially read the sample IDs of the sample containers 100 accommodated in the sample rack 110. The first information reading unit 817A and the second information reading unit 817B have, for example, a structure similar to that of the information reading unit 87, and are arranged so that two rollers sandwich the second transport path 812. The rollers are omitted in FIG. 8 to simplify the illustration.

[0104] 4, the first information reading unit 817A reads the sample ID of the sample container 100 having the storage position numbers 6 to 10, and the second information reading unit 817B reads the sample ID of the sample container 100 having the storage position numbers 1 to 5. The first information reading unit 817A further reads the rack ID from the machine-readable label 112 of the sample rack 110.

[0105] The third information reading unit 817C has a reading unit that is, for example, a barcode reader, and reads the rack ID. The third information reading unit 817C is disposed behind the fourth transport path 814.

[0106] The sample rack 110 transported from the second transport path 812 to the third transport path 813 by the second sender 816B is detected by sensors 818f, 818g, and is transported to the fourth transport path 814 by the third sender 816C. The sample rack 110 brought into the fourth transport path 814 is detected by the sensor 818h, and is transported to the first transport path 21 of the transport unit 20 by the fourth sender 816D. Note that the sample rack 110 transported to the transport unit 20 is collected by the collection unit 60 arranged downstream of the sample analysis system 1 as described above, and does not return to the supply unit 80.

[0107] The QC sample rack 160 containing the QC sample container 150 is supplied from the rack storage section 88 to the right end position of the second transport path 812, and then, like the sample rack 110, is transported to the first transport path 21 of the transport unit 20 via the second transport path 812, the third transport path 813, and the fourth transport path 814. The QC sample rack 160 is collected from the third transport path 23 of the transport unit 20 to the fifth transport path 815. The QC sample rack 160 transported to the fifth transport path 815 is detected by the sensor 818i and transported to the right end position of the fifth transport path 815 by the transport belt 815b. The QC sample rack 160 is detected by the sensor 818j at the right end position of the fifth transport path 815, and transported to the first transport path 811 by the fifth sending section 816E.

[0108] [Insertion section 83] 8, the insertion section 83 includes a first insertion section 83A that transfers the QC sample container 150 from a first insertion port 831A to an unloading position P5, and a second insertion section 83B that transfers the cleaning agent container 180 from a second insertion port 831B to an unloading section 839. The unloading position P5 is a position where the QC sample container 150 accessible to the transfer section 85 is unloaded, and the rear end of the first insertion section 83A becomes the unloading position P5. The unloading section 839 includes a transfer plate 839d, a sensor 839h, etc., and is provided at the rear end of the second insertion section 83B.

[0109] The first input section 83A includes a transfer path 830A for the QC sample container 150 extending along the front-rear direction. Similarly, the second input section 83B includes a transfer path 830B for the cleaning agent container 180 along the front-rear direction. In this embodiment, the transfer paths 830A and 830B are formed parallel to each other. Sensors 835f and 835g for detecting the transfer holder 834 are provided near the first input port 831A and near the removal position P5, respectively. The sensors 835f and 835g are, for example, proximity sensors such as magnetic sensors and eddy current sensors.

[0110] In the first input section 83A, a plurality of sensors 833e are installed at the first input port 831A. In the second input section 83B, a plurality of sensors 836d are installed along the transfer path 830B. The transfer path 830B of the second input section 83B is a passage for transferring the cleaning agent container 180, and also functions as a storage section for storing the plurality of cleaning agent containers 180. For this reason, a plurality of sensors 836d for detecting the cleaning agent containers 180 present in the transfer path 830B are installed along the transfer path 830B. The number of cleaning agent containers 180 stored in the transfer path 830B can be confirmed from the detection information of the plurality of sensors 836d.

[0111] Figures 9 and 10 are perspective views of the insertion unit 83. Figure 9 shows a state in which the transfer holder 834 is located at the first insertion unit 83A, and Figure 10 shows a state in which the transfer holder 834 is located at the removal position P5. As shown in Figures 9 and 10, the insertion unit 83 is a device in which the first insertion unit 83A and the second insertion unit 83B are integrated, and includes frames 833 and 836 that form transfer paths 830A and 830B that are inclined from the front to the rear.

[0112] The first input section 83A includes a transfer holder 834 and a drive mechanism 835 that moves the transfer holder 834 in the forward and backward directions. The transfer holder 834 is provided with a plurality of storage sections 834a capable of storing the QC sample containers 150 one by one. The transfer holder 834 is formed in a block shape as a whole, and a plurality of storage sections 834a, which are holes into which the QC sample containers 150 can be inserted, are formed on the upper surface of the transfer holder 834. The storage sections 834a are preferably formed to a depth such that, when the QC sample containers 150 are inserted, the upper portion of the tube 101 gripped by the arm 85b of the transfer section 85 protrudes from the upper surface of the transfer holder 834.

[0113] A through hole 834b communicating with the storage section 834a is formed on the side of the transfer holder 834. The through holes 834b are formed on both sides of the transfer holder 834 in a line in the left-right direction. In this embodiment, there are three storage sections 834a lined up in a line in the front-rear direction, and a total of six through holes 834b are formed for each storage section 834a, one on each side. The light emitting section and the light receiving section constituting the sensor 833e are installed on both sides of the frame body 833d so that light passes through the storage section 834a through the through hole 834b. This allows the first input port 831A to detect the presence or absence of the QC sample container 150 in each storage section 834a.

[0114] The drive mechanism 835 includes an endless belt 835a extending along the inclined portion 833c, a connecting member 835b connecting the transport holder 834 and the belt 835a, a motor 835c including a rotating shaft around which the belt 85c is suspended, a pulley 835d around which the belt 85c is suspended, and a rail 835e that guides the movement of the transport holder 834. The transport holder 834 is movably attached to the frame 833 via this drive mechanism 835.

[0115] The transfer holder 834 is configured to automatically move from the first input port 831A to the removal position P5 when a QC sample container 150 is stored in at least one of the storage sections 834a and the first cover 832A is closed. When the transfer holder 834 arrives at the removal position P5, the QC sample container 150 is removed from the storage section 834a by the transfer section 85 and transferred to the information reading section 87. When all the QC sample containers 150 are removed from the transfer holder 834, the transfer holder 834 automatically moves to the first input port 831A, for example.

[0116] As described above, the first cover 832A covering the first insertion opening 831A is locked so as not to open when the transport holder 834 is not in the position (also called the origin position) shown in Fig. 9. When the transport holder 834 arrives at the first insertion opening 831A and is detected by the sensor 835f, the lock of the first cover 832A is released.

[0117] The second input section 83B includes an opposing plate 837 attached to the frame 836 with a gap therebetween that allows the cleaning agent container 180 to be sandwiched therebetween. Between the frame 836 and the opposing plate 837, a rail 838 is provided that supports the flange 181 of the cleaning agent container 180 in a state in which the cleaning agent container 180 can slide. With the flange 181 supported and suspended by the rail 838, the cleaning agent container 180 slides along the transfer path 830B and is stored in the transfer path 830B.

[0118] The removal unit 839 includes a transfer plate 839d that moves in the left-right direction while holding the cleaning agent container 180, and is configured to project the cleaning agent container 180 upward when the transfer plate 839d moves to the left end side of the removal unit 839. The removal unit 839 also includes two support plates 839a and 839b that movably hold the transfer plate 839d, an inclined block 839c fixed to the lower parts of the support plates 839a and 839b, and a drive mechanism for the transfer plate 839d. The removal unit 839 includes a belt 839e, a motor 839f, a pulley 839g, and the like as a drive mechanism.

[0119] A holding portion capable of accommodating the cleaning agent container 180 is formed in the center of the transfer plate 839d. When the transfer plate 839d moves leftward while holding the cleaning agent container 180, the lower end of the cleaning agent container 180 comes into contact with the upper surface of the inclined block 839c. Since the upper surface of the inclined block 839c is inclined so as to become higher toward the left side, the cleaning agent container 180 is pushed up along the upper surface of the inclined block 839c and becomes capable of being grasped by the transfer portion 85.

[0120] The removal unit 839 is provided with a sensor 839h that detects the upward protrusion of the cleaning agent container 180. The light emitter and light receiver that constitute the sensor 839h are attached to the support plate 839a and are arranged so that an optical axis is formed along the left-right direction on the transfer plate 839d. When the sensor 839h detects the upward protrusion of the cleaning agent container 180, the transfer unit 85 transfers the cleaning agent container 180 from the removal unit 839 to an empty rack 170 in the rack storage unit 88.

[0121] [Cooling section 84] 11 and 12 are perspective views of the cold storage unit 84. FIG. 11 shows a state in which the cover 842 of the cold storage unit 84 is closed, and FIG. 12 shows a state in which the cover 842 of the cold storage unit 84 is open. FIG. 12 shows a state in which a part of the intake duct 846 is removed. The cold storage unit 84 is a storage cabinet for storing the QC sample container 150, and has a function of cooling the QC sample container 150. The cold storage unit 84 includes a block-shaped cold storage unit main body 841 that forms a cold storage chamber 841a for storing the QC sample container 150 in a cooled state, a cover 842 that covers the cold storage chamber 841a, and an opening / closing mechanism 843 for the cover 842. The cold storage unit main body 841 and the cover 842 have a rectangular shape in a plan view that is long in the left-right direction. The cold storage unit 84 includes a base 848 on which the cold storage unit main body 841 is placed.

[0122] The temperature of the cold storage chamber 841a and opening and closing of the cover 842 of the cold storage unit 84 are controlled by the control unit 82a. The temperature of the cold storage chamber 841a is, for example, 2°C to 8°C and is always controlled to a substantially constant temperature. The cooling of the cold storage unit 84 continues even after the sample analysis system 1 is shut down. The cover 842 is automatically opened and closed when the QC sample container 150 is inserted or removed.

[0123] The cold storage unit main body 841 includes a plurality of storage sections 841b that store the QC sample containers 150 one by one in an upright state in a cold storage chamber 841a covered by a cover 842. The storage sections 841b are holes that open upward and into which the QC sample containers 150 can be inserted, and in the example shown in Fig. 12, nine storage sections 841b are formed in a line in the left-right direction. The storage sections 841b are formed to a depth such that the upper part of the tube 101 gripped by the arm 85b of the transfer section 85 protrudes from the upper surface of the cold storage unit main body 841 when the QC sample container 150 is inserted.

[0124] In the cold storage unit main body 841, an evaporation compression type cooling device equipped with a compressor may be used as a cooling means, but in this embodiment, a Peltier element is built in from the viewpoint of miniaturization of the device. In the cold storage unit main body 841, a fan 845 is provided as a heat dissipation means for the Peltier element. In addition, in the cold storage unit main body 841, a metal cooling block cooled by the Peltier element, a heat dissipation fin, a temperature sensor, etc. are provided.

[0125] Cover 842 closes the opening of cold storage chamber 841a to keep the inside of cold storage chamber 841a airtight and at a low temperature. Cover 842 is formed in a block shape like cold storage unit main body 841, and has recess 842a formed on the inner surface facing cold storage unit main body 841. The inner surface of cover 842 has a flat peripheral portion that abuts against the upper surface of cold storage unit main body 841, and recess 842a is formed in the center along the longitudinal direction of cover 842. A rubber packing may be attached to the peripheral portion of the inner surface of cover 842.

[0126] Cover 842 is configured to be opened by rotating rightward by opening / closing mechanism 843 provided on the right end of cooling unit main body 841 .

[0127] The opening / closing mechanism 843 includes a rotating shaft 843a, a bearing member 843b fixed to the right end of the cooling unit main body 841 and rotatably supporting the rotating shaft 843a, a connecting member 843c connecting the right end of the cover 842 and the rotating shaft 843a, and a drive mechanism for rotating the rotating shaft 843a. The opening / closing mechanism 843 includes, as a drive mechanism for the rotating shaft 843a, an endless belt 843d suspended at the rear end of the rotating shaft 843a, and a motor 843e having a rotating shaft around which the belt 843d is suspended and driving the belt 843d. The rotating shaft 843a extends in the front-rear direction. The motor 843e is fixed to a base 848.

[0128] The opening / closing mechanism 843 includes two sensors 843f and 843g attached to the bearing member 843b and a metal plate 843h fixed to the front end of the rotating shaft 843a. An example of a suitable sensor 843f and 843g is a proximity sensor such as a magnetic sensor or an eddy current sensor. The sensors 843f and 843g are configured to be able to detect the opening and closing of the cover 842, for example, by detecting the proximity of the metal plate 843h that moves with the rotation of the rotating shaft 843a. In this embodiment, the sensor 843f detects the open state of the cover 842, and the sensor 843g detects the closed state of the cover 842.

[0129] Fan 845 is a heat dissipation means for releasing heat from the Peltier element, and is installed at the rear of cooler main body 841. Fan 845 is connected to intake duct 846 and exhaust duct 847, and intake duct 846 extending to the right is provided above fan 845, and exhaust duct 847 extending downward is provided below fan 845. When fan 845 operates, air is sucked in from the inlet of intake duct 846, passes through the heat generating section, and is exhausted from the outlet of exhaust duct 847.

[0130] [Transfer section 85] 13, the transfer section 85 includes a plate-like base section 85a that is long in the vertical direction, and a pair of arms 85b that grip the QC sample container 150. The base section 85a is provided so that the plate surface is aligned in the vertical direction and the front-rear direction. The pair of arms 85b are arranged at a distance from each other in the front-rear direction, and can move toward and away from each other. When the pair of arms 85b approach each other, the QC sample container 150 is gripped, and when the pair of arms 85b move away from each other, the QC sample container 150 is released.

[0131] The transfer section 85 is configured to remove the QC sample container 150 from the transfer holder 834 of the first input section 83A and transfer it to the cold storage section 84 via the information reading section 87. The transfer section 85 also removes the QC sample container 150 from the cold storage section 84 and transfers it to the rack storage section 88 via the heating section 86. The transfer section 85 returns the QC sample container 150 that has been collected in the rack storage section 88 after measurement in the measurement unit to the cold storage section 84, or inserts the used QC sample container 150 into the first collection section 89A for disposal.

[0132] The transfer section 85 is also configured to remove the cleaning agent container 180 from the second input section 83B and transfer it to the rack housing section 88. The cleaning agent container 180 is removed from an ejection section 839 (see FIG. 8, etc.) of the second input section 83B and transferred directly to the front end rack of the rack housing section 88. The transfer section 85 inserts the used cleaning agent container 180, which has been collected in the rack housing section 88 after cleaning of the measurement unit, into the second collection section 89B for disposal.

[0133] The base portion 85a is provided with an endless belt 85c extending in the front-rear direction, a pair of connecting members 85d connecting the pair of arms 85b and the belt 85c, a motor 85e including a rotating shaft around which the belt 85c is suspended, and a pulley 85f around which the belt 85c is suspended, as a drive mechanism for the arms 85b. The pair of arms 85b are attached to the base portion 85a so as to be movable by this drive mechanism. For example, a stepping motor is used as the motor 85e.

[0134] The pair of arms 85b can also move in three directions, namely, forward / backward, left / right, and up / down. The transfer unit 85 includes a first drive mechanism that moves the base unit 85a to which the arms 85b are attached in the forward / backward direction, and a second drive mechanism that moves the base unit 85a in the left / right direction. The base unit 85a is suspended with its upper end engaged with the first drive mechanism and the second drive mechanism 2, and is supported in a state in which it can move forward / backward and left / right relative to the frame 82f. The base unit 85a is also provided with a third drive mechanism 853 (see FIG. 14 described later) that moves the drive mechanism of the arms 85b, including the pair of arms 85b and the belt 85c, in the up / down direction.

[0135] The pair of arms 85b grip, for example, the upper portion of the tube 101 of the QC sample container 150. Since the QC sample container 150 includes a cap 102 having an outer diameter larger than that of the tube 101, the arm 85b grips the upper portion of the tube 101, whereby the arm 85b is caught on the cap 102, and the QC sample container 150 can be more reliably prevented from falling off. Also, since the cleaning agent container 180 has a flange 181 that protrudes radially outward formed at the upper end of the container, the pair of arms 85b grip a portion slightly below the flange 181.

[0136] [Heating section 86] As shown in Fig. 13, the heating unit 86 includes a block-shaped heating unit main body 86a and a storage unit 86b that stores a QC sample container 150. The storage units 86b are holes that open upward and into which the QC sample containers 150 can be inserted, and a plurality of storage units 86b are formed in the heating unit main body 86a. The storage units 86b store the QC sample containers 150 one by one in an upright state. In the example shown in Fig. 13, six storage units 86b are formed in a row in the left-right direction.

[0137] The storage section 86b is preferably formed to a depth such that the upper portion of the tube 101 gripped by the arm 85b of the transfer section 85 protrudes from the upper surface of the heating section main body 86a when the QC sample container 150 is inserted. The heating section 86 does not have a cover, and there are no large protrusions on the upper surface of the heating section main body 86a. The number, arrangement, etc. of the storage sections 86b are not particularly limited, and for example, the storage sections 86b may be arranged in a staggered pattern.

[0138] As described above, the heating section 86 heats the QC sample container 150 that has been cooled and stored in the cooling section 84, and has the function of adjusting the temperature of the quality control material contained in the QC sample container 150 to the measurement temperature in the measurement unit. The measurement temperature is 23°C ± 3°C. Since the suitable cooled storage temperature is 2°C to 8°C, the heating section 86 needs to raise the temperature of the quality control material by, for example, about 12°C to 24°C. The heating section 86 heats the QC sample container 150 inserted in the storage section 86b so that the quality control material in the QC sample container 150 reaches the measurement temperature.

[0139] The heating unit 86 is equipped with a heater that generates heat using electricity. The heater is preferably an aluminum block heater. Since an aluminum block heater uses an aluminum block as a heat medium, it is preferable because it does not soil the container as much as a liquid medium. In addition, since the aluminum block has high thermal conductivity, the time required to heat up can be shortened. By providing a heater, it is possible to quickly adjust the temperature even in an environment where the room temperature is low.

[0140] The heater temperature is set to a temperature higher than the measurement temperature within a range that does not deteriorate the quality control material, and in a preferred example, is set to 23° C.±3° C. The heating unit 86 may be equipped with a blowing means such as a fan that blows air into the storage unit 86b, and the quality control material may be heated by blowing air into the QC sample container 150 with the blowing means. The heating unit 86 may be equipped with a heater and a fan.

[0141] [Information reading unit 87] As shown in FIG. 13, the information reading unit 87 includes rollers 87a and 87b arranged to sandwich the storage section 87d of the QC sample container 150, and a reading unit 87c that reads the QC sample ID from the machine-readable label 103 of the QC sample container 150. At least one of the rollers 87a and 87b is configured to be movable in a direction approaching each other and to rotate. The information reading unit 87 drives at least one of the rollers 87a and 87b to rotate the QC sample container 150 arranged in the storage section 87d, and reads the QC sample ID with the reading unit 87c. The reading unit 87c is, for example, a barcode reader.

[0142] The QC sample container 150 is transferred from the first input section 83A to the information reading section 87, and the QC sample container 150 whose QC sample ID has been read by the information reading section 87 is transferred to the cold storage section 84 for cooling and storage. The information reading section 87 transmits the read QC sample ID information to the control section 82a, and the control section 82a uses the information to execute processing related to quality control. As will be described in detail later, the control section 82a uses the QC sample ID to manage the storage position of the QC sample container 150 in the cold storage section 84, and enables the selection of the QC sample container 150 to be used for quality control measurement.

[0143] [Rack storage area 88] 14 and 15 are perspective views showing the internal structure of the storage adjustment unit 82, showing an enlarged view of the rack accommodation section 88. The rack accommodation section 88 is equipped with a transport path 88a that can transport an empty rack 170 in the front-rear direction and can store a plurality of empty racks 170. The transport path 88a extends long in the front-rear direction at the right end of the storage adjustment unit 82. In this embodiment, a maximum of seven empty racks 170 can be stored in the transport path 88a.

[0144] The transport path 88a is provided with three stoppers 88b, 88c, and 88d in order from the front. The stopper 88c is disposed in the center of the transport path 88a in the front-rear direction and regulates the forward movement of the empty rack 170 stored in the transport path 88a. The stopper 88d is disposed closer to the rear end side of the transport path 88a than the stopper 88c and regulates the rearward movement of the empty rack 170. The area sandwiched between the stoppers 88c and 88d is an area in which the empty rack 170 can be stored, and in this embodiment, the distance between the stoppers 88c and 88d in the front-rear direction corresponds to the length of seven empty racks 170 in the front-rear direction.

[0145] As described above, the rack storage section 88 is also a place where the QC sample container 150 and the detergent container 180 are stored in the empty rack 170. Since the QC sample container 150 and the detergent container 180 are stored in the front end rack located at the front end of the multiple empty racks 170, a space is secured above the front end rack and its vicinity on the transport path 88a to serve as a path for the transfer section 85. The position of the front end rack is determined by a stopper 88c that stops the empty rack 170 from moving forward, and in this embodiment, it is aligned in the left-right direction with the first collection section 89A, the second collection section 89B, and the heating section 86.

[0146] The rack storage section 88 includes a transport arm 881 for transporting an empty rack 170, a QC sample rack 160 housing a QC sample container 150, and a rack housing a detergent container 180 (hereinafter referred to as a "detergent rack") in the forward and backward directions. The transport arm 881 is capable of pushing the empty rack 170 etc. forward and also capable of pulling the empty rack 170 etc. backward. The rack storage section 88 is provided with a pair of transport arms 881 so as to sandwich the transport path 88a from both the left and right sides. In addition, a claw portion 881a protruding toward the inside of the transport path 88a is formed at the tip of the pair of transport arms 881.

[0147] The configuration of the rack housing unit 88 will be described in further detail below with reference to Figures 16 and 17. The transport path 88a of the rack housing unit 88 is connected to the second transport path 812 of the conveyor unit 81, and is disposed so as to face the first transport path 811 across the second transport path 812. That is, the first transport path 811 and the transport path 88a are disposed side by side in the front-rear direction. The transport path 88a is connected to the right end side of the second transport path 812, and is connected to the first transport path 811 and the third transport path 813 via the second transport path 812.

[0148] The stopper 88b of the transport path 88a is a movable stopper arranged at the front end of the transport path 88a, and prevents the sample rack 110, etc., pushed from the first transport path 811 to the second transport path 812 from entering the transport path 88a. When an empty rack 170, etc., is transported into the transport path 88a, the stopper 88b is lowered so as not to protrude from the upper surface of the transport path 88a. Since the empty rack 170, etc., is transported to the rear of the stopper 88c, the stopper 88c is lowered in conjunction with the stopper 88b. The stoppers 88b, 88c may be mechanically connected by, for example, a link mechanism or the like.

[0149] The transport arm 881 can move in the front-rear direction to the front of the second transport path 812, and can push the QC sample rack 160 and the like to the second transport path 812, and can also pull the QC sample rack 160 and the like from the second transport path 812 into the transport path 88a. The QC sample rack 160 is transported from the rack storage section 88 via the second transport path 812 to the third transport path 813 and the fourth transport path 814. The QC sample rack 160 returned to the supply unit 80 by the fifth transport path 815 is collected in the rack storage section 88 via the first transport path 811 and the second transport path 812.

[0150] The transport arm 881 moves in the front-rear direction by a drive mechanism similar to that of the first send-out unit 816A. The two transport arms 881 are also configured to be movable in directions approaching and separating from each other, and can send out the QC sample racks 160 and the like one by one to the second transport path 812. Specifically, the transport arm 881 can move in the left-right direction between an engagement position where the claw portion 881a of the transport arm 881 is positioned on the transport path 88a and engages with a rack on the transport path 88a, and a retracted position where the claw portion 881a is retracted from the transport path 88a.

[0151] For example, when the transport arm 881 is moved forward from the rear of the transport path 88a past the empty rack 170 to push out the QC sample rack 160 (front end rack) to the second transport path 812, the transport arm 881 from the retracted position is moved to the position of the QC sample rack 160. Then, the transport arm 881 is moved to the engagement position to insert the claw portion 881a between the QC sample rack 160 and the empty rack 170 immediately behind it. By moving the transport arm 881 forward in this state, the rear surface of the front end rack is pressed by the claw portion 881a of the transport arm 881, and the QC sample rack 160 is pushed out to the second transport path 812.

[0152] In the rack storage section 88, four sensors 882a, 882b, 882c, and 882d are provided in order from the front along the transport path 88a. The sensor 882a detects a rack between stoppers 88b and 88c at the front end side of the transport path 88a, and the sensor 882b detects a front-end rack. When an empty rack 170 is stored in the rack storage section 88, the transport arm 881 transports the empty rack 170 forward so that a front-end rack capable of accommodating a QC sample container 150 and a detergent container 180 is always present.

[0153] The sensor 882c detects the QC sample container 150 and the detergent container 180 accommodated in the front end rack. The sensor 882d detects the presence or absence of a rack at the rear end side of the transport path 88a, specifically, the empty rack 170 immediately before the stopper 88d (see FIG. 15). If the empty rack 170 is not detected by the sensor 882d, this means that a rack containing a QC sample container 150 or a detergent container 180 is being transported to the measurement unit, or otherwise, there is space in the rack accommodation section 88 that can accommodate the empty rack 170.

[0154] The sensors 882a, 882b, 882c, and 882d may be optical sensors, similar to the sensors of the conveyor unit 81. For example, the sensors 882a and 882c may be optical sensors with a separate light emitting unit and light receiving unit, and the sensors 882b and 882d may be reflective optical sensors with an integrated light emitting unit and light receiving unit. As will be described in detail later, the control unit 82a controls the stoppers 88b and 88c and the transport arm 881 based on the detection information of each sensor, and performs rack transport in the rack accommodation unit 88.

[0155] [Monitor 91 operation screen] Hereinafter, the screens displayed on the monitor 91 of the supply unit 80 will be described in detail with reference to FIGS.

[0156] 18 is an example of a home screen 1000 displayed on the monitor 91 of the supply unit 80. The home screen 1000 includes a toolbar 1000A, a main area 1000B in which an operation menu is displayed, and a status display area 1000C in which a status is displayed. As described above, the monitor 91 is configured with a touch panel, and all icons displayed on the screen 1000 are displayed so as to be selectable by the user. A portal screen display icon 1005 for displaying a portal screen 2600 shown in FIG. 27 described later is arranged on the toolbar 1000A.

[0157] The main area 1000B displays a device status icon 1001 for checking the status of the supply unit 80 or replenishing consumables for the supply unit 80, and a schedule icon 1002 for registering and editing a schedule. The main area 1000B may further include other icons as shown in FIG.

[0158] 19 is an example of an apparatus status screen 2000 that is displayed in response to selection of the apparatus status icon 1001. The apparatus status screen 2000 includes, as contents to be displayed in the main area, a QC status window 2001, a cleaning agent container inventory window 2006, an empty rack inventory window 2007, a waste bin window 2008, and a temperature display window 2009.

[0159] The QC status window 2001 includes a QC sample list 2001A that displays a list of information on QC samples under the control of the supply unit 80, and a remaining amount display section 2001B that displays the remaining amount of each concentration level of the QC samples under control.

[0160] The QC sample list 2001A displays a list of information on the QC sample containers 150 under the control of the supply unit 80. For example, as shown in Fig. 19, the QC sample list 2001A includes nine rows corresponding to the nine storage sections 841b provided in the cooling section 84. The QC sample list 2001A includes, from the leftmost column, a first column indicating the position number of the storage section 841b, a second column indicating the concentration level of the QC sample, a third column indicating the lot number, a fourth column indicating the number of remaining tests, and a fifth column indicating the expiration date.

[0161] In the example of Fig. 19, for example, information on the QC sample container 150 accommodated in the accommodation section 841b of position number 1 is displayed in the row corresponding to position number "1". In the example of Fig. 9, the information registered for the QC sample container 150 accommodated in position number "1" is that the concentration level is "Level 1", the lot number is "A001XXXX", the remaining amount is 20 tests, and the expiration date is "March 30, 2021".

[0162] The information of the QC sample list 2001A is registered by reading the information of the QC sample container 150 set via the above-mentioned input unit 83 by the information reading unit 87. The machine-readable label 103 of the QC sample container 150 stores attribute information including the concentration level of the QC sample, the lot number, the number of remaining tests, and the expiration date. The information reading unit 87 acquires the above information based on the information read from the machine-readable label 103 and transmits it to the control unit 82a. The QC sample container 150 from which the information has been read is accommodated in one of the vacant storage units 841b of the cooling unit 84 by the transport unit 85. The control unit 82a stores the above information read by the information reading unit 87 in the database 820 (see FIG. 28 described later) in association with the position number of the storage unit 841b in which the QC sample container 150 is accommodated.

[0163] The information of the QC sample list 2001A displays a list of information on the QC sample containers 150 under the management of the supply unit 80. Even if the QC sample container 150 has been removed from the cold storage section 84 (e.g., is being transported for quality control measurement), the information on the QC sample container 150 is displayed in the row of the position number corresponding to that QC sample container 150. Information on the QC sample container 150 removed from the cold storage section 84 is displayed with a different background color so as to be distinguished from the QC sample container 150 stored in the cold storage section 84, as shown by hatching in FIG. 19.

[0164] As shown in Fig. 19, the QC sample list 2001A highlights the corresponding cell in the fourth column that displays the remaining amount when the number of remaining tests falls below a predetermined value. For example, in the example of Fig. 19, the color of the cell corresponding to the QC sample container 150 at position number 3 where the number of remaining tests is less than 1 is displayed inverted. The threshold value for highlighting can be set appropriately, and for example, the QC sample container 150 may be highlighted when the number of remaining tests falls below 5. This allows the user to easily recognize the presence of a QC sample container 150 with little or no remaining amount.

[0165] As shown in FIG. 19, the QC sample list 2001A highlights the corresponding cell in the fifth column displaying the expiration date when the expiration date of the QC sample container 150 stored in the cooling section 84 has passed. For example, in the example of FIG. 19, the color of the cell corresponding to the QC sample container 150 at position number 6 whose expiration date has passed is displayed inverted. The conditions for highlighting can be set appropriately, and for example, the highlighting may be displayed when the number of days remaining until the expiration date falls below a threshold value. For example, the highlighting may be displayed when the number of days remaining until the expiration date falls below 10 days. This allows the user to easily recognize the existence of a QC sample container 150 whose expiration date is approaching or has passed.

[0166] In the example of FIG. 19, only the cells in the fourth or fifth column are highlighted, but the entire row may be highlighted.

[0167] A remaining amount display section 2001B is provided above the QC sample list 2001A. The remaining amount display section 2001B displays the total number of remaining uses for each type of control blood, i.e., for each concentration level of the QC sample container 150. In the example of FIG. 19, the remaining numbers of tests for QC samples at concentration levels 1, 2, and 3 are displayed as 44 tests, 53 tests, and 1 test, respectively. The value of the remaining amount display section 2001B is equal to the total number of remaining tests for QC samples displayed in the QC sample list 2001A for each concentration level. The remaining amount display section 2001B eliminates the need for the user to calculate the remaining number of tests for each concentration level, making management easier.

[0168] The detergent container inventory window 2006 displays the remaining number of detergent containers 180 stored in the supply unit 80. As described above, the second input section 83B has a plurality of sensors 836d installed along the transfer path 830B. Of these, the sensor 836d at the front of the device (lower side of the paper in FIG. 8) is disposed at a position where it can detect the 15th detergent container from the top. The control section 82a displays the remaining number of detergent containers 180 based on the output from the sensor 836d at the front. For example, when the detergent container 180 is detected by the sensor 836d, as shown in FIG. 19, "15+" is displayed, indicating that the remaining number is 15 or more. If the sensor 836d detects the detergent container 180 once and then no longer detects the detergent container 180 due to consumption of the detergent container 180, the control section 82a subtracts the number used from 15 and displays the number of detergent containers in inventory.

[0169] In addition, in the modified supply unit 80K described below, the total number of detergent containers set in the unit is recognized by the control unit 82a, and the number of displayed inventory bottles changes depending on the number of detergent containers used by the supply unit 80.

[0170] The empty rack inventory window 2007 displays the number of empty racks 170 accommodated in the rack accommodation unit 88. The control unit 82a recognizes the number of empty racks 170 based on the outputs of the sensors 882c and 882d, and displays the number in the empty rack inventory window 2007.

[0171] The waste box window 2008 displays the number of containers that can be disposed of in each of the first and second collection sections 89A and 89B, which are waste boxes.

[0172] The temperature display window 2009 displays the temperature inside the cooling section 84, the temperature of the heating block of the heating section 86, and the outside air temperature.

[0173] The toolbar of the device status screen 2000 displays a shutdown icon 2003, a removal icon 2004, and an insertion icon 2005. The shutdown icon 2003 is used when shutting down all or part of the sample analysis system 1. The removal icon 2004 is used when removing a QC sample container 150 stored in the cooling section 84. The removal icon 2004 will be described later with reference to FIG. 21. The insertion icon 2005 is used when setting the QC sample container 150 in the first insertion section 83A of the insertion section 83.

[0174] 20 is an example of a shutdown screen 2100 that is displayed when the shutdown icon 2003 on the device status screen 2000 is pressed. The shutdown screen 2100 displays a shutdown menu. The shutdown menu includes three options: "Specified device," "Entire system," and "Shutdown of supply unit (BT-50) alone."

[0175] When "designated device" is selected on the shutdown screen 2100, a device selection screen 2101 is displayed. The device selection screen 2101 includes a device selection area 2101A that selectably displays multiple devices, namely, the measuring units 10A and 10B and the processing unit 40, according to the layout of the sample analysis system. The user selects the device to be shut down by following the guidance on the screen. The screen 2101 also displays the next scheduled automatic start-up schedule 2101B and a button 2101C for calling up details of the next automatic start-up schedule. The user confirms the next automatic start-up schedule displayed on the screen and then presses the OK button at the bottom of the screen, whereby the selected device is shut down. Shutting down the measuring unit and the processing unit means, for example, as described below with reference to FIG. 50, transporting a detergent rack containing detergent containers to the device, performing cleaning in the device, and turning off the power of the device after cleaning is completed. In the following description, the four measurement units constituting sample analysis system 1 will be referred to as "XN-1," "XN-2," "XN-3," and "XN-4," respectively, and processing unit 40 will be referred to as "SP-1."

[0176] When "Entire System" is selected on the shutdown screen 2100, a system shutdown confirmation screen 2102 is displayed. Similar to screen 2101, screen 2102 displays the next scheduled automatic startup and a button to call up the details of the next schedule. When the OK button at the bottom of the screen is pressed, the entire system is shut down.

[0177] When "End supply unit alone" is selected, a supply unit shutdown screen 2103 is displayed to reconfirm to the user that only the supply unit 80 is to be shut down. When the OK button at the bottom of the screen 2103 is pressed, only the supply unit 80 is shut down independently. Shutting down the supply unit 80 means turning off the power of the supply unit 80, and the cleaning agent rack is not transported.

[0178] When the OK button is pressed on the screens 2101 to 2103, if there is a shortage of consumables to be used for the automatic QC associated with the next automatic startup schedule, a screen 2104 is displayed. The screen 2104 includes a message saying, "There is a shortage of consumables required to execute the next scheduled execution content registered in the schedule." This screen 2104 is displayed when the QC sample containers 150 stored in the cooling section 84 and the empty racks 170 stored in the rack storage section 88 are insufficient for the amount required to execute the automatic QC associated with the next automatic startup schedule when a shutdown instruction is received via the screens 2101 to 2103. The control section 82a of the supply unit 80 stores the remaining number of tests for each concentration level of the QC sample containers 150 stored in the cooling section 84, as described with reference to FIG. 19. The control section 82a also stores the number of empty racks 170 stored in the rack storage section 88. The control unit 82a judges whether there is a sufficient stock of QC sample containers 150 and whether there is a sufficient stock of empty racks 110 based on the QC conditions of the automatic QC to be executed at the next automatic startup, and if there is a shortage, displays a screen 2104 on the monitor 91. If the user wishes to cancel the shutdown and replenish the consumables, the user presses Cancel. If the user wishes to continue the shutdown as is, the user presses the OK button, and the shutdown continues as instructed. By displaying the screen 2104 before the shutdown, it is possible to prevent, for example, the supply unit 80 from being shut down without replenishing the consumables required for the automatic QC the next day.

[0179] On the device selection screen 2101, the desired device can be shut down simply by selecting the device on the screen and pressing the OK button. This eliminates the need for the user to shut down each device one by one, which is highly convenient. It is also convenient in that it eliminates the need for the user to perform manual operations such as using a detergent rack with a rack barcode dedicated to a specific device in order to supply detergent containers 180 to a specific device.

[0180] Furthermore, when shutting down the entire system, the user only needs to press the OK button on screen 2102. This eliminates the need for the user to go to the trouble of shutting down all of the devices. Furthermore, even if sample analysis system 1 includes multiple devices, it is convenient because there is no need to manually prepare detergent container 180 required to clean all of the devices.

[0181] FIG. 21 is an example of a QC sample removal screen 2200 that is displayed in response to the removal icon 2004 on the device status screen 2000 being selected. The screen 2200 includes the same QC sample list as that included in the device status screen 2000, and a position selection button 2201. While checking the QC sample list, the user can select the position selection button 2201 corresponding to the position number of the QC sample container 150 to be removed, and select the OK button at the bottom of the screen. The position selection button 2201 can simultaneously select up to three QC sample containers 150 corresponding to the maximum number of containers that the transfer holder 834 can carry, which is three. In the example of FIG. 21, the QC sample containers 150 with position numbers 2, 6, and 7 are selected. As described with reference to FIG. 19, the QC sample containers 150 with position numbers 1, 4, and 5 have been removed from the cooling unit 84 and cannot be removed. Therefore, the position selection buttons 2201 corresponding to these position numbers are not selectable, and the check boxes are grayed out.

[0182] When the QC sample container 150 to be removed is selected by the position selection button 2201 and the OK button is pressed, the selected QC sample container 150 is removed from the cooling section 84 and set in the transfer holder 834 at the removal position P5 (position shown in FIG. 10) of the insertion section 83. Thereafter, the transfer holder 834 in which the QC sample container 150 is set moves to the first insertion port 831A (position shown in FIG. 9). When the transfer holder 834 moves to the first insertion port 831A, a notification screen 2210 is displayed on the monitor 91 to inform the user that the QC sample container 150 (XN CHECK) has arrived at the first insertion port 831A. The user can open the first cover 832A and remove the QC sample container 150.

[0183] 22 is an example of an input screen 2300 displayed in response to the selection of the input icon 2005 on the device status screen 2000. When the input icon 2005 is selected, the transport holder 834 is positioned at the first input port 831A, and the lock of the first cover 832A is released. The screen 2300 is a screen for prompting the user to set the QC sample container 150, and is displayed on the monitor 91, for example, at the timing when the lock of the first cover 832A is released. When the user sets the QC sample container 150 in the transport holder 834 and presses the OK button at the bottom of the screen, the QC sample container 150 is transported inside the supply unit 80 and stored in the cooling section 84. This process will be described later.

[0184] FIG. 23 is an example of a schedule screen 2400 that is displayed in response to the selection of the schedule icon 1002 on the home screen 1000. The schedule screen 2400 includes seven day of the week tabs 2401 provided corresponding to each day of the week in a week, and a schedule list 2402 that displays a list of schedules. The day of the week tabs 2401 display seven tabs that display the names of seven days of the week, Monday, Tuesday, Wednesday, Thursday, Friday, Saturday, and Sunday, in a selectable manner. The user can specify the day of the week for which the schedule is to be set by selecting any tab. Note that FIG. 23 shows an example in which a schedule is registered for each day of the week, but, for example, a schedule may be registered by specifying a date. For example, a weekly or monthly calendar may be displayed, and a schedule may be registered by specifying a specific date on the calendar.

[0185] FIG. 23 illustrates a state in which the Monday tab is selected. In the schedule list 2402, schedules to be executed on a specified day of the week are displayed in chronological order. In the example of FIG. 23, wake-up (automatic start-up) is scheduled for 7:30 a.m. on Monday, quality control measurement (automatic QC) for 1:00 p.m., and automatic cleaning for 11:00 p.m. are scheduled. A button 2403 for switching ON / OFF is provided corresponding to each schedule in the schedule list 2402. The user operates the button 2403 to set the button to "ON" when executing a registered schedule, or to "OFF" when not executing the schedule. A schedule set to ON is automatically executed at the same time every week unless it is set to OFF.

[0186] A registration icon 2404 for registering a schedule is selectably displayed on the toolbar of the schedule screen 2400. When the user wants to add a new automatic execution schedule to the schedule list 2402, he or she presses the registration icon 2404.

[0187] Fig. 24 is an example of a schedule registration screen 2500 that is displayed in response to selection of the registration icon 2404 on the schedule screen 2400. The screen 2500 displays a menu for selecting a process to be automatically executed. In the example of Fig. 24, three selectable menus are displayed: "Start-up", "Quality control", and "Cleaning". In this embodiment, information on the registered schedule is stored in the memory of the control unit 82a.

[0188] When the "Start" menu of the schedule registration screen 2500 is selected, a registration screen 2501 is displayed. The screen 2501 is a screen for registering an automatic wake-up schedule. The screen 2501 includes a plurality of pull-down buttons for inputting the day of the week and the time for automatic wake-up. When the day of the week pull-down button is selected, a pull-down menu including seven days of the week, Monday, Tuesday, Wednesday, Thursday, Friday, Saturday, and Sunday, as options is displayed. The user can select any day of the week. The time pull-down includes a pull-down button for specifying the time in one hour units and a pull-down button for specifying the time in minutes units. The user can specify the time by operating the pull-down menu. Although only the pull-down menu is illustrated in the example of FIG. 24, a software keyboard may be displayed to accept numerical input from the user. By operating the screen 2501, the user can specify the day of the week and the time for automatic wake-up to be executed.

[0189] The registration screen 2501 further includes a button for turning on / off the execution of automatic QC. The user operates the button to turn "ON" when automatic QC is to be performed, or to turn "OFF" when automatic QC is not to be performed. Automatic QC is an automatic quality control measurement using the QC sample container 150 stored in the cooling unit 84.

[0190] When an automatic wake-up schedule with auto QC set to ON is registered, one or more measurement units included in sample analysis system 1 are automatically started according to the schedule, and further, QC sample container 150 is automatically supplied to the started one or more measurement units to perform quality control measurement. When an automatic wake-up schedule with auto QC set to OFF is registered, the power of each unit of sample analysis system 1 is automatically turned on, but quality control measurement is not performed.

[0191] When the automatic QC button is set to "ON" on the registration screen 2501 and the "OK" button at the bottom of the screen is pressed, the screen transitions to registration screen 2502. The registration screen 2502 is also displayed when the "Quality Control" menu is selected on the schedule registration screen 2500. The sample analysis system 1 accepts settings of the conditions for quality control measurement (QC conditions) from the user on the registration screen 2502. As will be described in detail later, the sample analysis system 1 determines one or more QC sample containers 150 to be used for quality control measurement from among the multiple QC sample containers 150 stored in the cooling section 84 according to the QC conditions and the information on the QC sample containers 150, and transports the determined QC sample containers 150 to the measurement unit to measure the QC sample.

[0192] Registration screen 2502 is a screen for creating an automatic QC schedule. Like screen 2501 described above, screen 2502 includes multiple pull-down buttons for specifying days of the week and times. Below the pull-down buttons, three concentration level buttons, "Level 1," "Level 2," and "Level 3," are provided as buttons for selecting the type of QC sample to be used in one automatic QC. Below the concentration level buttons, a unit selection image is displayed for selecting a measurement unit for which quality control measurement is to be performed in the automatic QC. The unit selection image includes an image illustrating multiple units arranged according to the layout of sample analysis system 1.

[0193] The user sets the day of the week and time for performing automatic QC on the registration screen 2502. The operations for setting the day of the week and time are as described above. The user operates the concentration level button to select the type of QC sample to be used for automatic QC. In the example of FIG. 24, levels 1 and 2 are specified as the concentration levels of the QC sample. Level 3 is unspecified and is in the off state. The user selects the measurement unit for which quality control measurement is to be performed in automatic QC from the unit selection image.

[0194] In FIG. 24, the rightmost measuring unit XN-1 and the third and fourth measuring units NX-3 and NX-4 from the right are selected. In the example of the setting shown in FIG. 24, the conditions for automatic QC are set to perform quality control measurement using two QC sample containers 150 of levels 1 and 2 at 8:30 a.m. on Monday for three measuring units, XN-1, XN-3, and XN-4. When the "OK" button at the bottom of the screen 2502 is selected, a confirmation screen 2510 (described later) is displayed, and when a confirmation operation is performed, the input schedule is registered in the list. In this embodiment, the registered conditions for automatic QC are stored in the memory of the control unit 82a.

[0195] When the "Cleaning" menu is selected on the schedule registration screen 2500, a registration screen 2503 is displayed. The screen 2503 is a screen for registering a schedule for automatic cleaning. Automatic cleaning is automatic cleaning of the measuring unit and the processing unit using the cleaning agent container 180 stored in the second input section 83B. The registration screen 2503 differs from the registration screen 2502 in that it does not have a concentration level button for selecting the type of QC sample and includes the processing unit 40 (SP-10), which is a smear preparation device, as a selectable unit, but otherwise has the same configuration as the screen 2502.

[0196] On the registration screen 2503, the user operates the pull-down buttons at the top of the screen to specify the day of the week and time to perform automatic cleaning. The user selects a unit selection image to specify the unit to be subjected to automatic cleaning. When the "OK" button at the bottom of the registration screen 2503 is selected, the input schedule is registered in the schedule list after operation on the confirmation screen.

[0197] Fig. 25 is an example of a confirmation screen 2510 that is displayed when an automatic QC schedule is entered on the registration screen 2502 and the "OK" button is pressed. As shown in Fig. 25, the confirmation screen 2510 displays the specified day of the week, time, and automatic execution content. When an automatic QC schedule that specifies multiple concentration levels is created on the registration screen 2502, the combination of the multiple concentration levels is displayed as the content of the automatic execution schedule, as shown in Fig. 25.

[0198] Fig. 26 illustrates operations for an automatic execution schedule displayed in a schedule list from the schedule screen 2400 in Fig. 23. When a user selects an automatic execution schedule that he or she wishes to operate on in screen 2400, an operation menu 2410 is displayed. The operation menu 2410 includes three options: "Execute," "Edit," and "Delete."

[0199] "Execute" is used to execute a selected schedule ahead of the scheduled time. When "Execute" is pressed in the operation menu 2410, a confirmation screen 2420 including the scheduled automatic execution details is displayed along with a confirmation message asking "Do you want to execute the selected schedule contents now?" When the "OK" button is pressed on this confirmation screen 2420, quality control measurements are started according to the scheduled QC conditions. When a schedule is executed ahead of the scheduled time by operating the "Execute" menu, the schedule is not executed at the originally scheduled time.

[0200] "Edit" is used to change the contents of an already registered schedule. For example, it is used to change the time at which automatic QC is performed, or to change the concentration level used in automatic QC or the unit targeted for quality control measurement. When "Edit" is pressed, a screen similar to one of screens 2501, 2502, or 2503 shown in FIG. 24 is displayed depending on the type of schedule to be edited, and editing can be performed via the screen. When editing is performed, the contents of the schedule list are updated based on the edited contents.

[0201] "Delete" is used to delete a schedule that has already been registered. When deleted, the target schedule is removed from the schedule list.

[0202] 27 is an example of a portal screen 2600. The portal screen 2600 includes a schedule display area 2601 that displays a list of schedules scheduled for the day, and an inventory display area 2602 that displays the inventory status of consumables stored by the supply unit 80. The content displayed in the schedule display area 2601 is a chronological list of scheduled schedules corresponding to the day of operation among the automatic execution schedules registered on the schedule registration screen 2500, from the top.

[0203] In the inventory display area 2602, the inventory status of the consumables stored by the supply unit 80 is displayed in the form of a graph. In the example of FIG. 27, the remaining amounts of multiple types of consumables are displayed in a bar graph on the horizontal axis, which starts from the current time and indicates future dates to the right. The bar graph indicates how long the consumables will be sufficient if the registered schedule is executed as scheduled using the inventory of consumables stored in the supply unit 80. In the example of FIG. 27, a bar graph is displayed showing the inventory amounts of the QC sample containers 150 of concentration levels 1, 2, and 3 and the cleaning agent container (CCA) 180. A message regarding the inventory of the consumables is displayed below the graph. For example, if the number of empty racks 170 stored in the rack storage unit 88 falls below a predetermined number, for example, a message such as "Empty racks: Refillable" is displayed as shown in FIG. 27. In addition, the message includes an alert that prompts the user to replenish the consumables when there is a shortage of consumables required to execute the scheduled automatic execution schedule. For example, in FIG. 27, when the remaining number of tests of QC samples with concentration level 3 is insufficient for the automatic QC schedule scheduled for the next day, the message "L3: The number of tests required for tomorrow's automatic QC is insufficient. Please replenish." is displayed. The automatic execution schedule that is the target of the alert may be, for example, a schedule scheduled for the current day, the next day, or the next working day, or may be the next scheduled automatic start schedule. By confirming the alert, the user can replenish the consumables in advance. In FIG. 27, the date on which the schedule can be executed within the range of the stock of the consumables is displayed by a bar graph, but the display format does not need to be a graph, and only the date may be displayed. In addition, the display is not limited to the date, and the remaining number of days or the remaining number of times the schedule can be executed based on the stock may be displayed by a numerical value or a graph.

[0204] FIG. 28 is a block diagram showing the configuration of the supply unit 80, and also shows the connection relationship between the supply unit 80, the module 10, and the transport controller 70. The control unit 82a is connected to each of the devices, namely, the input unit 83, the cooling unit 84, the transport unit 85, the heating unit 86, the information reading unit 87, and the rack storage unit 88. The control unit 82a sends control signals to these devices to control the operation of each device. In this embodiment, among the processes related to the quality control measurement, the processes performed in the storage adjustment unit 82 are executed under the control of the control unit 82a. The transport of the QC sample rack 160 by the conveyor unit 81 and the transport unit 20 of the module 10 is mainly executed under the control of the transport controller 70, and the measurement of the quality control material in the measurement unit is executed under the control of the control unit 30.

[0205] The control unit 82a is configured by a computer, similar to the control unit 31 of the control unit 30 and the control unit 71 of the transport controller 70, and includes a processor, a storage unit, and an input / output port. A control program for executing processes such as cooling storage, transportation, and heating of the QC sample container 150 is installed in the control unit 82a. The control unit 82a further stores a database 820 that stores information on the quality control samples. The database 820 is information on each QC sample container 150 associated with the position number of the storage unit 841b of the cooling unit 84, as described above.

[0206] A database 310 relating to the results of quality control measurements is stored in the control section 31 of the control unit 30. The database 310 stores QC files which are the measurement results of QC samples for each measurement date and time, and for each concentration level and lot of the QC sample. An example of a QC file stored in the database 310 is shown in FIG. 49, which will be described later. Using this database 310, the user can check, for example, the state of the measurement unit and the differences between lots of QC samples, which will be described later.

[0207] FIG. 29 is an example of a database 820 stored in the control unit 82a. The database 820 includes attribute information and remaining amount information of each QC sample container 150 stored in the cold storage unit 84. The attribute information preferably includes at least one of the concentration level, lot information, and expiration date of the QC sample. In the example of FIG. 29, from the leftmost column, the first column indicates the position number of the storage unit 841b of the cold storage unit 84, the second column indicates the concentration level of the QC sample container 150, the third column indicates the lot number, the fourth column indicates the remaining number of tests, which is remaining amount information, and the fifth column indicates the expiration date. Based on this database 820, the above-mentioned QC sample list 2001A is created, and one or more QC sample containers 150 to be used for quality control measurement are determined.

[0208] An example of the processing relating to automatic QC and automatic cleaning of the sample analysis system 1 will be described in detail below with reference to Figures 30 to 41. The processing relating to automatic QC and automatic cleaning is mainly executed by the functions of the control section 31 of the control unit 30 and the control section 82a of the supply unit 80. Below, Figures 42 to 45 showing the operation of the supply unit 80 will be referred to as appropriate.

[0209] Figure 30 is a flow chart showing a series of processes in the sample analysis system 1. The processes in Figure 30 are executed by the control unit 82a of the supply unit 80. When an automatic wake-up schedule is registered, the control unit 82a determines whether the current time is a predetermined time before the designated time (step S1). When the current time is a predetermined time before the designated time, the control unit 82a executes the automatic wake-up (step S2). The process in S2 will be described later with reference to Figure 31.

[0210] When the power of each unit constituting the system is turned on by automatic wake-up, the control unit 82a judges whether the scheduled automatic QC time has arrived (step S10). This judgment is made based on the registration information of the automatic QC schedule stored in the control unit 82a. When the control unit 82a judges that the automatic QC time has arrived, it starts quality control measurement using the QC sample container 150 (step S100). The processing of S100 will be described later with reference to FIG. 32.

[0211] If the result in step S10 is NO, the control unit 82a judges whether the scheduled time for automatic cleaning has arrived (step S20). This judgment is made based on the registration information of the automatic cleaning schedule stored in the control unit 82a. If the control unit 82a judges that the time for automatic cleaning has arrived, it starts automatic cleaning using the cleaning agent container 180 (step S200). The processing of S200 will be described later with reference to FIG. 34.

[0212] If NO in step S20, the control unit 82a judges whether or not the addition of the QC sample container 150 has been instructed by the user (step S30). For example, the control unit 82a judges whether or not the input icon 2005 on the device status screen 2000 of Fig. 19 has been operated. If the input icon 2005 has been operated (YES in step S30), the control unit 82a performs a process of storing the QC sample container 150 in the cooling unit 84 (step S300). The process of S300 will be described later with reference to Fig. 35.

[0213] If NO in step S30, the control unit 82a judges whether or not the user has instructed to remove the QC sample container 150 (step S40). For example, the control unit 82a judges whether or not the removal icon 2004 on the device status screen 2000 of Fig. 19 has been operated. If the removal icon 2004 has been operated (YES in step S40), the control unit 82a performs a process of removing the QC sample container 150 from the cooling unit 84 (step S400). The process of S400 will be described later with reference to Fig. 36.

[0214] If the result in step S40 is NO, the control unit 82a judges whether or not a rack is set on the conveyor unit 81 of the supply unit 80 (step S50). If the control unit 82a judges that a rack is set (step S50 is YES), the control unit 82a performs rack storage or rack transport processing according to the type of rack (step S500). The processing of S500 will be described later with reference to FIG.

[0215] If the result in step S50 is NO, the control unit 82a judges whether or not the rack sent out from the supply unit 80 has returned to the conveyor unit 81 (step S60). If the control unit 82a judges that the rack has returned (step S60 is YES), it performs a predetermined collection process according to the type of rack (step S600). The process of S600 will be described later with reference to FIG.

[0216] 31 to 36, 40 and 41 are flowcharts showing the operation of the supply unit 80.

[0217] FIG. 31 is a flow chart showing the automatic wake-up process. In step S2A, the control unit 82a turns on the power of the supply unit 80. This starts the supply of power to the heater of the heating unit 86, and the temperature inside the heating unit 86 is raised to the set temperature (23° C.). In step S2B, the control unit 82a transmits a start-up command to each unit of the sample analysis system 1 when the current time is a predetermined time before the specified time. This causes the power of all units constituting the sample analysis system 1 to be turned on. Note that the screen 2501 in FIG. 24 may be configured so that the unit that will perform the automatic wake-up can be specified, and the start-up command is transmitted only to the specified unit based on the schedule registration information.

[0218] The predetermined time is preferably longer than the time required for the QC sample container 150 stored in the cooling unit 84 to be heated by the heating unit 86 until it reaches a temperature at which it can be measured (hereinafter, referred to as the heating time). For example, if the heating time is 10 minutes, the predetermined time is preferably at least 10 minutes or more. More preferably, the predetermined time includes, in addition to the heating time, the time required for the heated QC sample to be measured by the measurement unit and the measurement result to be obtained. In one example, the predetermined time is, for example, 30 minutes. That is, if the wake-up time is set to 8:30, the control unit 82a transmits a start command at 8:00. In this way, the QC sample can be in a state where the heating and measurement are completed at the time specified by the user as the wake-up time, and the user can immediately start testing using the measurement unit at the specified time. The predetermined time may be fixed or may be variable depending on the presence or absence of automatic QC and the QC conditions.

[0219] In step S2C, the control unit 82a determines whether or not automatic QC is set to ON. When automatic QC is set to ON as shown on screen 2501 in Fig. 24, the control unit 82a executes automatic QC in step S100 following automatic wake-up. That is, when an automatic wake-up schedule in which automatic QC is set to ON is registered, the power of each unit of the sample analysis system 1 is automatically turned on at a specified time on a specified day of the week, and quality control measurement using the QC sample container 150 is automatically started. When automatic QC is set to OFF, only automatic wake-up is executed, and quality control measurement is not performed.

[0220] Fig. 32 is a flowchart showing the automatic QC process (step S100 in Fig. 30) in the supply unit 80. The procedure shown in this flowchart applies not only to the automatic QC executed following automatic wake-up, but also to the automatic QC executed at a timing other than wake-up. In step S101, the control unit 82a determines a combination of QC sample containers 150 to be used for the quality control measurement based on the conditions for the quality control measurement (QC conditions) and information on the QC samples being stored. Although one QC sample container 150 may be used for the quality control measurement, generally two or more QC sample containers 150 with different concentration levels of the QC samples are used.

[0221] The QC conditions include the specification of one or more measurement units for performing quality control measurement. When one or more measurement units for performing quality control measurement are specified, the control unit 82a determines one or more QC sample containers 150 to be used according to the number of specified measurement units. Furthermore, the QC sample information includes information on the type of QC sample, and the QC conditions include a specification of the type of QC sample to be used. The control unit 82a determines one or more QC sample containers 150 to be used based on the specified QC sample type and the information on the QC sample type.

[0222] The QC conditions may include designation of multiple concentration levels as the type of QC sample, designation of the lot of the QC sample to be used, etc. The control unit 82a determines a combination of multiple QC sample containers 150 based on, for example, the multiple designated concentration levels. Also, one or more QC sample containers 150 are determined based on the designated lot and lot information of the QC sample. The information on the QC sample may include information on the remaining amount of the QC sample in each QC sample container 150, and one or more QC sample containers 150 may be determined based on the number of designated measurement units and the remaining amount information.

[0223] Although details will be described later, when the remaining amount of the first QC sample container 150 used for quality control measurement is not sufficient for the number of tests to be performed based on the number of specified measurement units, a combination of the first QC sample container 150 and the second QC sample container 150 is determined as the container to be used. In this case, a container with the same concentration level as the first QC sample container 150 is selected as the second QC sample container 150. The remaining amount of the QC sample container 150 is determined, for example, based on at least the concentration level and lot information of the QC sample, and the QC conditions.

[0224] As described above, the information on the QC samples includes attribute information and remaining amount information on each QC sample. Examples of the attribute information include the concentration level, lot information, and expiration date of the QC sample. The remaining amount information is, for example, the number of times the QC sample can be used. The information on the QC samples is stored in the storage unit of the control unit 82a as the database 820. The QC conditions are also stored in the storage unit.

[0225] In step S102, the control unit 82a controls the QC sample container 150 to be removed from the cooling unit 84 and transferred to the heating unit 86. Specifically, the control unit 82a controls the cooling unit 84 to open the cover 842. The control unit 82a controls the transfer unit 85 to remove the QC sample container 150 determined in S101 from the cooling unit 84. The control unit 82a stores information on the QC sample container 150 in the database 820 in association with the position numbers of the nine storage units 841b in the cooling unit 84. The control unit 82a controls the transfer unit 85 to remove the container from the storage unit 841b corresponding to the determined position number of the QC sample container 150 and set it in the heating unit 86. The control unit 82a starts timing when the QC sample container 150 is set in the heating unit 86.

[0226] In step S103, when a predetermined time has elapsed since the QC sample container 150 was set in the heating unit 86, the control unit 82a transfers the QC sample container 150, whose temperature has been adjusted to the measurement temperature, from the heating unit 86 to an empty rack 170 in the rack storage unit 88. The control unit 82a controls the transfer unit 85 to store the QC sample container 150 in the empty rack 170. When multiple QC sample containers 150 are used for quality control measurement, each QC sample container 150 is stored in the empty rack 170 based on the automatic QC conditions stored in the memory unit.

[0227] In step S104, the control unit 82a controls the QC sample rack 160 containing the QC sample container 150 to be transported from the supply unit 80. The control unit 82a controls the rack storage unit 88 to send the QC sample rack 160 to the second transport path 812 of the conveyor unit 81. The control unit 82a controls the conveyor unit 81 to transport the QC sample rack 160 from the supply unit 80 through the third transport path 813 and the fourth transport path 814. The control unit 82a notifies the control unit 71 of the transport controller 70 of the measurement unit that is the destination of the QC sample rack 160. The control unit 71 of the transport controller 70 controls each transport unit 20 so that the QC sample rack 160 is transported to the notified measurement unit.

[0228] Fig. 42 is a diagram showing the operation of the supply unit 80 in steps S102 to S104 in Fig. 32. As shown in Fig. 42(a), under the control of the control unit 82a, the transfer unit 85 removes the QC sample container 150 from the storage unit 841b of the cooling room 841a and stores it in the storage unit 86b of the heating unit 86. Thereafter, when a predetermined time has elapsed since the QC sample container 150 was transferred to the heating unit 86, the transfer unit 85 transfers the QC sample container 150 to an empty rack 170 in the rack storage unit 88, as shown in Fig. 42(b).

[0229] When the number of QC sample containers 150 required for quality control measurement are accommodated in the accommodation section 111 of the empty rack 170 (front end rack), as shown in Figure 42 (c), the rack accommodation section 88 sends out the QC sample rack 160, which is the front end rack accommodating the QC sample containers 150, to the second transport path 812 of the conveyor section 81. The QC sample rack 160 is transported from the supply unit 80 through the third transport path 813 and the fourth transport path 814 of the conveyor section 81.

[0230] FIG. 33 is a flow chart showing a specific example of a process (step S101 in FIG. 32) for determining a combination of QC sample containers 150 to be used in quality control measurement. In step S1000, the control unit 82a sets a variable N related to the concentration level to 1. In step S1001, the control unit 82a judges whether or not a measurement of a QC sample of concentration level N is necessary. If the variable N is 1, it is judged whether or not a measurement of a QC sample of concentration level 1 is necessary. The judgment in step S1001 is made based on the designation of the concentration level of the QC condition stored in the storage unit. For example, as shown in the screen 2502 in FIG. 24, if the QC condition includes the measurement of a QC sample of concentration level 1, it is judged as YES in step S1001. If the measurement of a QC sample of concentration level 1 is not designated, steps S1002 and S1003 are skipped and the process proceeds to step S1004.

[0231] In step S1002, the control unit 82a identifies one QC sample container 150 from the QC sample containers 150 stored in the cooling unit 84 based on the concentration level and lot number registered in the database 820. For example, a usable QC sample container 150 is identified from among the QC sample containers 150 with the same lot number as the QC sample container 150 of the concentration level 1 in operation. If there are multiple QC sample containers 150 with the same lot number, the one with the fewest remaining tests is identified.

[0232] In step S1003, the control unit 82a judges whether the number of remaining tests for the identified QC sample container 150 is equal to or greater than the number of tests for the quality control measurement. This judgment is made based on the information on the number of remaining tests for the QC sample container 150 registered in the database 820. That is, the control unit 82a compares the number of remaining tests for the identified QC sample container 150 with the number of tests planned to be performed in the quality control measurement to be performed, and judges YES if the number of remaining tests is equal to or greater than the number of tests planned to be performed.

[0233] In step 1004, the control unit 82a judges whether or not QC sample containers 150 of all concentration levels required for quality control measurements have been identified. This judgment is made based on the concentration level designation of the QC conditions stored in the storage unit. For example, if measurements of concentration levels 1 and 2 are designated as QC conditions, steps S1001 to S1003 are executed for concentration level 2.

[0234] If the control unit 82a judges NO in step S1003, that is, if the number of remaining tests of the identified QC sample container 150 is less than the number of tests to be performed, it judges in step 1005 whether or not another usable QC sample container 150 with the same concentration level is stored in the cooling unit 84. This judgment is made based on the database 820. If another usable QC sample container 150 with the same concentration level is stored (YES in step S1005), the control unit 82a sums the number of remaining tests of the other QC sample container 150 and the number of remaining tests of the previously identified QC sample container 150 (step S1006). Then, it returns to step S1003 again and judges whether or not the summed number of remaining tests is equal to or greater than the number of tests to be performed.

[0235] The procedure of steps S1003, S1005, and S1006 is repeated until YES is determined in step S1003. If no other usable QC sample containers 150 of the same concentration level are stored in the cooling section 84 (NO in step S1005), the control section 82a outputs an automatic QC error in step S1007 and cancels the automatic QC schedule. The automatic QC error is information that is output when there are insufficient stored QC samples for the registered automatic QC schedule. The notification of the automatic QC error is displayed on the monitor 91, for example. In this case, the user needs to set a QC sample container 150 of concentration level 1 in the supply unit 80.

[0236] Fig. 34 is a flowchart showing the automatic cleaning process (step S200 in Fig. 30) in the supply unit 80. The automatic cleaning is performed based on an automatic cleaning schedule, and a cleaning agent rack containing a cleaning agent is transported to a unit specified in the schedule. In step S201, the control unit 82a controls the cleaning agent container 180 stored in the second input unit 83B to be moved to a position where it can be grasped by the transfer unit 85. The control unit 82a controls the removal unit 839 of the second input unit 83B to bring the cleaning agent container 180 into a state where it can be grasped by the transfer unit 85.

[0237] The control unit 82a controls the transfer of the cleaning agent container 180 to an empty rack 170 in the rack storage unit 88 in step S202, and controls the transportation of the cleaning agent rack housing the cleaning agent container 180 from the supply unit 80 in step S203.

[0238] Fig. 43 is a diagram showing the operation of the supply unit 80 in steps S201 to S203 in Fig. 34. The cleaning agent container 180 is transferred by the second input unit 83B from the second input port 831B (see Fig. 9, etc.) to the removal unit 839 accessible to the transfer unit 85. However, as shown in Fig. 43(a), when the transfer plate 839d is located on the right end side of the removal unit 839, the transfer unit 85 cannot grip the cleaning agent container 180. For this reason, as shown in Fig. 43(b), the transfer plate 839d that houses the cleaning agent container 180 is moved to the left end side of the removal unit 839.

[0239] As a result, the lower end of the cleaning agent container 180 comes into contact with the upper surface of the inclined block 839c (see FIG. 9, etc.) arranged below the transfer plate 839d and is pushed up, so that the cleaning agent container 180 can be grasped by the transfer unit 85. At this time, the pushed-up cleaning agent container 180 is detected by the sensor 839h. When the cleaning agent container 180 is detected by the sensor 839h, the transfer unit 85 takes out the cleaning agent container 180 from the take-out unit 839 and transfers it to the empty rack 170, as shown in FIG. 43(c). As with the QC sample container 150, the cleaning agent container 180 is transferred from the take-out unit 839 in the number required for cleaning and is stored in the front end rack of the rack storage unit 88. As with the QC sample rack 160, the cleaning agent rack that stores the cleaning agent container 180 is transported from the rack storage unit 88 through the second transport path 812, the third transport path 813, and the fourth transport path 814 of the conveyor unit 81 from the supply unit 80 to the measurement unit.

[0240] Fig. 35 is a flow chart showing the process (step S300 in Fig. 30) of storing the QC sample container 150 in the cooling section 84 of the supply unit 80. As described above, the process in Fig. 35 is executed when the user operates the input icon 2005 on the device status screen 2000. In step S301, the control unit 82a controls the locking mechanism of the first cover 832A of the first input unit 83A to unlock the first cover 832A. When the lock of the first cover 832A is unlocked, in step S302, the control unit 82a displays a screen prompting the user to set the QC sample container 150. An example of this screen is the input screen 2300 in Fig. 23, which is displayed on the monitor 91.

[0241] In step S303, when the QC sample container 150 is set in the transfer holder 834, the first cover 832A is closed, and the OK button on the input screen 2300 is pressed, the control unit 82a controls to lock the first cover 832A. The control unit 82a controls the transfer holder 834 to transfer the QC sample container 150 into the storage adjustment unit 82. At this time, the transfer holder 834 moves to the removal position P5 of the first input unit 83A. In step S304, the control unit 82a controls the transfer unit 85 to transfer the QC sample container 150 from the removal position P5 to the information reading unit 87. In step S305, the information reading unit 87 reads information on the QC sample container 150 under the control of the control unit 82a.

[0242] In step S306, the control unit 82a controls the transfer unit 85 to transfer the QC sample container 150 from the information reading unit 87 to the cold storage unit 84. The transfer unit 85 accommodates the QC sample container 150 in the accommodation unit 841b of the cold storage room 841a under the control of the control unit 82a. In step S307, the control unit 82a registers the information of the QC sample container 150 acquired by the information reading unit 87 in the database 820 in association with the position number of the accommodation unit 841b in which the QC sample container 150 is accommodated. The accommodation position of the QC sample container 150 in the cold storage unit 84 may be determined at the time when the information reading unit 87 acquires the information. In this case, when the information reading unit 87 acquires the information and transmits it to the control unit 82a, the information of the QC sample container 150 may be registered in the database 820 in association with the position number of the accommodation unit 841b.

[0243] FIG. 44 is a diagram showing the operation of the supply unit 80 in steps S301 to S306 in FIG. 35. As shown in FIG. 44(a), when storing the QC sample container 150 in the cooling section 84 of the supply unit 80, the user sets the QC sample container 150 in the transfer holder 834 at the first insertion port 831A of the first insertion section 83A. Since the first insertion port 831A is covered with the first cover 832A, the user needs to open the first cover 832A to set the QC sample container 150. The first insertion section 83A is provided with a locking mechanism for the first cover 832A, and when the transfer holder 834 is present at the first insertion port 831A, the lock of the first cover 832A is released, and the first cover 832A can be opened.

[0244] In the first insertion port 831A, the transfer holder 834 is detected by the sensor 835f. When the sensor 835f detects the transfer holder 834, for example, the input icon 2005 (see FIG. 23) on the monitor 91 becomes operable, and when the input icon 2005 is pressed, the lock of the first cover 832A is released. By making the first cover 832A openable only when the transfer holder 834 is present in the first insertion port 831A, it is possible to prevent the QC sample container 150 from being mistakenly inserted into the first insertion port 831A where the transfer holder 834 is not present.

[0245] When a QC sample container 150 is set in the storage section 834a of the transfer holder 834 and the first cover 832A is closed, the control section 82a moves the transfer holder 834 to transfer the QC sample container 150 into the storage adjustment unit 82. Since a sensor 833e is provided in the first insertion port 831A corresponding to each storage section 834a, the presence or absence of a QC sample container 150 and the number of inserted QC sample containers 150 can be detected from the detection information of the sensor 833e.

[0246] 44(b), the transfer holder 834 moves from the first input port 831A to the removal position P5 inside the storage adjustment unit 82. When the transfer holder 834 arrives at the removal position P5 and is detected by the sensor 835g, the transfer section 85 removes the QC sample containers 150 from the transfer holder 834 and transfers them one by one to the information reading section 87. In the information reading section 87, rollers 87a and 87b rotate the QC sample containers 150 arranged in the storage section 87d, and the reading section 87c reads the QC sample ID from the machine-readable label 103.

[0247] As shown in FIG. 44(c), the transfer unit 85 transfers the QC sample container 150 from the information reading unit 87 to the cold storage unit 84 and stores it in the storage unit 841b of the cold storage room 841a. When the transfer of all the QC sample containers 150 to the cold storage unit 84 is completed, the cold storage unit 84 closes the cover 842 and starts the cooling storage of the QC sample containers 150. In the example of FIG. 44(c), after all the QC sample containers 150 are removed from the transfer holder 834, the transfer holder 834 is returned to the first insertion port 831A. The read information of the QC sample ID is transmitted to the control unit 82a. The QC sample ID includes information on the concentration level, lot number, and expiration date of the QC sample. The control unit 82a updates the database 820 based on the received information of the QC sample ID. In addition, since the number of remaining tests for an unused QC sample container 150 is 24 tests, when adding a new QC sample container 150 to the database 820, the control unit 82a inputs 24 as the initial value of the number of remaining tests.

[0248] FIG. 36 is a flow chart showing the process (S400 in FIG. 30) of removing the QC sample container 150 from the cold storage section 84 of the supply unit 80. As described above, the process in FIG. 36 is executed when the removal icon 2004 on the device status screen 2000 is operated. In step S401, the control unit 82a controls the transfer holder 834 to move it into the storage adjustment unit 82. At this time, the transfer holder 834 moves to the removal position P5 of the first insertion section 83A. In step S402, the control unit 82a controls the transfer unit 85 to remove the QC sample container 150 accommodated in the accommodation section 841b corresponding to the position number designated on the screen 2200 in FIG. 21 from the cold storage section 84, and set it in the transfer holder 834 at the removal position P5.

[0249] In step S403, the control unit 82a controls the transfer holder 834 in which the QC sample container 150 is set to move to the first insertion port 831A. In step S404, the control unit 82a unlocks the first cover 832A, and in step S405, displays a screen notifying the arrival of the QC sample container 150. An example of this screen is the notification screen 2210 in FIG. 21, which is displayed on the monitor 91.

[0250] 37 to 39 are flow charts showing the operation of the measuring unit. The operation of the measuring unit is mainly controlled by the control unit 31. Below, the operation will be described taking the first measuring unit 10A as an example, but the same applies to the second measuring unit 10B.

[0251] 37 is a flow chart showing an example of a measurement procedure for a sample container 100, but steps S1101 and S1102 are common to the QC sample container 150 and the detergent container 180. In step S1101, the control unit 31 transports the sample rack 110 to the second transport path 22 arranged in front of the first measurement unit 10A, and in step S1102, causes the information reading unit 26 to read the sample ID and the rack ID. The sample container 100 whose sample ID has been read is transported to a removal position P2 corresponding to either the first measurement unit 10A or the second measurement unit 10B. Here, it is assumed that the sample container 100 is transported to the removal position P2 of the first measurement unit 10A.

[0252] In step S1103, the control unit 31 determines the type of container based on the sample ID read in step S1102. If it is determined that the container transported to the removal position P2 is a sample container 100, the process proceeds to step S1104. If the container transported to the removal position P2 is a QC sample container 150, the process proceeds to step S1201 in Fig. 38, and if it is a detergent container 180, the process proceeds to step S1301 in Fig. 39.

[0253] In step S1104, the control unit 31 inquires of the host computer 120 about the measurement order and acquires the measurement order, and in step S1105, controls the robot hand 15 to remove the sample container 100 from the storage unit 111 of the sample rack 110. Under the control of the control unit 31, in step S1106, the robot hand 15 inverts and mixes the removed sample container 100, and in step S1107, the aspirating tube 13a of the sample preparation unit 13 aspirates the sample from the sample container 100. After the aspirating of the sample is completed, in step S1108, the sample container 100 is returned to the original storage unit 111 of the sample rack 110 by the robot hand 15.

[0254] Under the control of the control unit 31, in step S1109, the sample preparation unit 13 prepares a measurement sample from the aspirated specimen, and the measurement unit 14 measures the sample (initial test) and analyzes the measurement data. In step S1110, the control unit 31 determines whether or not to perform a retest based on the measurement result of the initial test. If a retest is to be performed, the process returns to step S1105, and if a retest is not to be performed, the result of the initial test is sent to the host computer 120 (step S1111). When the initial test and necessary retests are completed for all sample containers 100 accommodated in the sample rack 110, smears are prepared via the processing unit 40 as necessary, and then the samples are transported to the collection unit 60 (step S1112).

[0255] Fig. 38 is a flow chart showing an example of a processing procedure when the container is the QC sample container 150 in step S1103 of Fig. 37. In step S1201, the control unit 31 inquires of the control unit 82a of the supply unit 80 about the QC conditions to acquire the QC conditions, and transports the QC sample container 150 to be measured to the target take-out position P2 of the first measurement unit based on the QC conditions. Under the control of the control unit 31, in step S1202, the robot hand 15 takes out the QC sample container 150 from the storage unit 111 of the QC sample rack 160, and in step S1203, inverts and mixes the taken-out QC sample container 150. Note that information on the registered QC conditions may be provided to the control unit 31 in advance, in which case the inquiry in step S1201 is unnecessary.

[0256] Under the control of the control unit 31, in step S1204, the aspirating tube 13a of the sample preparation unit 13 aspirates the QC sample from the QC sample container 150, and in step S1205, the robot hand 15 returns the QC sample container 150 to the original storage unit 111 of the QC sample rack 160. In step S1206, the sample preparation unit 13 prepares a measurement sample from the aspirated QC sample, and the measurement unit 14 measures the sample (initial test) and analyzes the measurement data. When the QC sample is aspirated in step S1204, the control unit 31 notifies the control unit 82a of the supply unit 80 of the information. The information on the number of times the QC sample has been aspirated is used when updating the number of remaining tests in the database 820. Alternatively, when the control unit 82a receives this notification, it may update the database 820 by subtracting the number of remaining tests for the corresponding QC sample container 150.

[0257] When retesting to remeasure a QC sample is set as the QC condition, the control unit 31 determines whether retesting is necessary (step S1207). For example, when the measured value is abnormal, such as when the measured value is outside a predetermined allowable range or when the error from the previous value is outside the allowable range, it is determined that retesting is necessary. In this embodiment, it is assumed that retesting is performed automatically up to once. In other words, when steps S1201 to S1206 are repeated due to retesting, the process proceeds to step S1208 regardless of the result of the retest.

[0258] In step S1208, the control unit 31 determines whether or not to output a QC error. A QC error is output when the measurement value of the QC sample is still abnormal even after retesting, for example, when the measurement value of the QC sample falls outside a predetermined allowable range, or when the error from the previous value falls outside the allowable range. The QC error is displayed, for example, on the monitor 91 of the supply unit 80.

[0259] When the control unit 31 outputs the QC error, it sends a predetermined notification to the transport controller 70 (step S1209). The predetermined notification includes information identifying the measurement unit in which the QC error occurred. The transport controller is programmed to prohibit the transport of the sample container 100 to the measurement unit in which the QC error occurred. Since the sample analysis system 1 has a plurality of measurement units, the sample container 100 is supplied only to the measurement unit in which the measurement value of the QC sample is normal, and the measurement unit in which the measurement value of the QC sample is abnormal is excluded from the supply destination of the sample container 100. For example, when a QC error occurs in either of the measurement units 10A and 10B of the upstream measurement block 10 in the sample analysis system 1 of FIG. 1, the transport controller 70 can exclude the upstream measurement block from the supply destination of the sample container 100 and supply the sample container only to the downstream measurement block 10. In this way, it is possible to prevent the sample from being erroneously measured by a measurement unit in which the accuracy is not guaranteed due to the occurrence of the QC error. Furthermore, since the measurement can be started by another normal measurement unit while the measurement unit in which the QC error occurred is being restored, it is highly convenient.

[0260] Based on the measurement values ​​of the QC sample, the control unit 31 creates a QC file (step S1210). As described above, the QC file is the measurement result of the QC sample created for each concentration level and lot, and is stored in the database 310. If a QC file has already been created for the same concentration level and lot as the measured QC sample, the file is updated by adding new measurement values ​​to the QC file. In step S1211, the control unit 31 determines whether or not all quality control measurements of the first measurement unit have been completed based on the QC conditions. If all measurements have not been completed, for example, when measurements of QC samples of different concentration levels are required, steps S1201 to S1211 are repeated.

[0261] When all measurements in the first measurement unit are completed (step S1211: YES), the control unit 31 updates the status of the first measurement unit based on the QC result (step S1212). The status includes, for example, two statuses: standby and error. Standby is a state in which the measurement unit can measure a sample. Error is a state in which an error occurs in the measurement unit, and the measurement of a sample is impossible or prohibited. The control unit 31 sets the status of the measurement unit to standby when the QC result is normal, that is, when there is no QC error. The control unit 31 is programmed to control the transport unit 20 so that the sample container 100 is supplied to the measurement unit whose status is standby when the sample rack 110 containing the sample container 100 is transported. The control unit 31 sets the status of the measurement unit to error when there is a QC error. The control unit 31 is programmed not to supply a sample to the measurement unit whose status is error. The measurement unit in which an error has occurred can be put into standby by, for example, the user manually measuring a QC sample or performing error recovery.

[0262] The control unit 31 queries the control unit 82a of the supply unit 80 about the destination of the QC sample rack 160 (step S1213) and determines the destination (step S1214). If there is a next measurement unit as the destination of the QC sample rack 160 (step S1214: YES), the transport unit 20 transports the QC sample rack 160 to the next measurement unit under the control of the control unit 31 (step S1215). For example, if the next measurement unit is the second measurement unit 10B, the transport unit 20 transports the QC sample rack 160 from the first measurement unit 10A to the second measurement unit 10B by the second transport path 22. If the next measurement unit is the adjacent measurement block, the transport unit 20 transports the QC sample rack 160 downstream by the belt 21b of the first transport path 21 (see FIG. 5). When the destination of the QC sample rack 160 is the supply unit (NO in step S1214), the transport unit 20 transports the QC sample rack 160 via the third transport path 23 to transport the QC sample rack 160 to the supply unit 80 (step S1216).

[0263] Fig. 39 is a flow chart showing an example of the processing procedure when the container is the cleaning agent container 180 in step S1103 in Fig. 37. In this case, the cleaning agent container 180 is taken into the first measurement unit 10A and a cleaning process is performed. In step S1301, the control unit 31 causes the robot hand 15 to take out the cleaning agent container 180 from the storage unit 111 of the cleaning agent rack, and in step S1302, inserts the suction tube 13a into the cleaning agent container 180 to aspirate the cleaning agent, thereby cleaning the suction tube 13a and the flow path.

[0264] The cleaning agent container 180 is returned to the rack after a predetermined time has elapsed (step S1303), and the cleaning agent rack containing the cleaning agent container 180 is transported to the supply unit 80 (step S1304). Thereafter, the control unit 82a judges whether or not the execution of automatic shutdown is set to ON (step S1305). This judgment is made based on the registration information of the schedule stored in the control unit 82a. If the automatic shutdown is set to ON, for example, after the processing of the used cleaning agent container 180 is completed, the control unit 82a turns off the power of the measurement unit 10A or 10B that has been cleaned (step S1306).

[0265] Fig. 40 is a flow chart showing the processing (S500 in Fig. 30) of a rack set on the first transport path 811 of the conveyor section 81. As described above, the supply unit 80 is provided with the first transport path 811 which is accessible from the outside so that a user can set a rack, and the sample rack 110 and the empty rack 170 are set on the first transport path 811 by the user. The rack set on the first transport path is detected by the sensor 818b.

[0266] In step S501, the control unit 82a executes control to transport the rack from the first transport path 811 to the second transport path 812, and detects the container by the sensor 818d. In step S502, the control unit 82a judges whether the rack set on the first transport path 811 is the sample rack 110 or the empty rack 170. The control unit 82a judges the type of the rack based on whether a container is accommodated in the rack. If a container is detected, the control unit 82a judges that the rack is a sample rack, and if no container is detected, the control unit 82a judges that the rack is an empty rack. Note that the process of FIG. 40 is executed when the user sets the rack on the first transport path 811, and in this embodiment, it is assumed that the QC sample rack 160 accommodating the QC sample container 150 returns to the supply unit 80 via the fifth transport path 815, so there is no branch corresponding to the QC sample rack 160 in the judgment of S501.

[0267] If the rack set on the first transport path 811 is a sample rack 110, the sample rack 110 is transported to the measurement unit under the control of the control unit 82a and the transport unit 70 (step S503). If the rack set on the first transport path 811 is an empty rack 170, the empty rack 170 is transported to the rack storage section 88 and stored in the rack storage section 88 (step S504).

[0268] Fig. 45 is a diagram showing the operation of the supply unit 80 in steps S502 and S504 in Fig. 40. As shown in Fig. 45(a), when a user sets an empty rack 170 on the first transport path 811, the empty rack 170 is detected by the sensor 818b and pushed from the first transport path 811 to the right end side of the second transport path 812 by the first sending unit 816A. Next, as shown in Fig. 45(b), the empty rack 170 is detected by the sensor 818c at the right end position of the second transport path 812, moved to the left end position by the belt 812b of the second transport path 812, and detected by the sensor 818e.

[0269] In the second transport path 812, when the sensor 818d does not detect a container and it is confirmed that the rack is an empty rack 170, the empty rack 170 is returned to the right end position of the second transport path 812 by the belt 812b again as shown in FIG. 45(c). Then, as shown in FIG. 45(d), the empty rack 170 is detected by the sensor 818c and drawn into the transport path 88a by the transport arm 881. The empty rack 170 is drawn by the transport arm 881 to the position of the front end rack behind the stopper 88c. At this time, the stoppers 88b and 88c are lowered in conjunction with each other so as not to impede the transport of the empty rack 170.

[0270] 41 is a flowchart showing the process (S600 in FIG. 30) when a rack returns to the supply unit 80. As described above, the supply unit 80 is provided with the fifth transport path 815 for receiving a rack from the adjacent transport unit 20, and the QC sample rack 160 and the cleaning agent rack return to the supply unit 80.

[0271] In step S601, the control unit 82a controls the second transport path 812 to transport a rack, and reads the IDs of the containers accommodated in the rack by the first information reading unit 817A and the second information reading unit 817B.

[0272] The control unit 82a controls the second transport path 812 and the rack storage unit 88 to collect the rack whose container ID has been read, into the rack storage unit 88 (step S602). The control unit 82a determines whether the returned rack is a QC sample rack 160 or a detergent rack based on the ID read in step S601 (step S603). If the container stored in the rack is a QC sample container 150, the control unit 82a determines that the rack is a QC sample rack 160. If the container stored in the rack is a detergent container 180, the control unit 82a determines that the rack is a detergent rack.

[0273] If the collected rack is a QC sample rack 160 containing a QC sample container 150, the control unit 82a controls the transport unit 85 and the cold storage unit 84 to store the QC sample container 150 in the cold storage unit 84 again (step S604). The control unit 82a updates the database 820 based on the processing in step S602 (step S605). Specifically, the control unit 82a updates the number of remaining tests of the QC sample in the database 820 based on the notification of suction from the QC sample container 150 received from the measurement units 10A and 10B. In the above embodiment, the QC sample container 150 is stored again in step S602 regardless of the remaining amount, but the QC sample container 150 may be processed based on the remaining amount information, for example. For example, the QC sample container 150 with the remaining test number of 1 or more may be transported to the cold storage unit 84 and stored, and the QC sample container 150 with the remaining test number of less than 1 may be transported to the first collection unit 89A and discarded.

[0274] If the collected rack is a cleaning agent rack containing a cleaning agent container 180, the control unit 82a controls the transfer unit 85 to transfer the cleaning agent container 180 from the rack to the second collection unit 89B and discard it (step S606).

[0275] 46 to 48 are diagrams for explaining in detail the process of determining a combination of QC sample containers 150 based on the QC conditions and information on the stored QC sample containers 150 in step S101 in Fig. 32. In the following, it is assumed that the QC sample containers 150 shown in the database 820 in Fig. 29 are stored in the cooling section 84.

[0276] FIG. 46 shows cases A to C. <Case A> In Case A, the following QC conditions are set: Concentration level used: Level 1, 2 - Units subject to quality control measurement: XN1, XN2, XN3, XN4 ·Block straddling: Yes

[0277] Block crossing is a setting regarding whether or not quality control measurements of multiple measurement blocks are performed using one QC sample rack 160. If block crossing is "enabled," quality control measurements of the entire sample analysis system are performed using the QC sample containers 150 set in one QC sample rack 160. Whether block crossing is enabled or disabled can be changed according to the user's preference, such as whether to prioritize the efficiency of automatic QC or the ease of management of QC samples.

[0278] For example, when block crossing is set to "not allowed," the QC sample rack 160 is transported to each of the multiple measurement blocks. Since parallel quality control measurements are possible for multiple measurement blocks, quality control measurements can be efficiently performed for the entire sample analysis system.

[0279] When block crossing is set to "enabled," multiple measurement blocks can be quality controlled using QC sample containers 150 set in one QC sample rack 160. When quality control measurements are performed in parallel, for example, multiple QC sample containers 150 with the same concentration level are used simultaneously, which can make management of expiration dates and lot numbers complicated. In this regard, when block crossing is set to "enabled," the same QC sample container 150 is used in, for example, the first measurement block and the second measurement block, making it possible to reduce the number of QC sample containers 150 consumed at one time and easier management.

[0280] In case A, since block crossing is set to "allowed," the QC sample containers 150 at levels 1 and 2 are accommodated in one rack. The control unit 82a identifies usable QC sample containers 150 from among the QC sample containers 150 with the same lot number as the lot number in operation. Here, the lot number in operation is assumed to be "A01XXXX" for level 1 and "A02XXXX" for level 2. In this case, for level 1, the QC sample containers 150 at position numbers 1 and 2 are identified as usable containers. For level 2, the QC sample containers 150 at position numbers 4 and 5 are identified as usable containers.

[0281] When only one QC sample container 150 is available based on the lot number, the control unit 82a determines whether the number of remaining tests in that container is equal to or greater than the number of tests scheduled to be performed by the automatic QC. As described above, if the number of remaining tests is less than the number of tests scheduled to be performed, the control unit 82a outputs an automatic QC error and cancels the schedule. If the number of remaining tests is equal to or greater than the number of tests, the control unit 82a sets the identified QC sample container 150 in the rack.

[0282] If there are two or more QC sample containers 150 available based on the lot number, it is determined whether the number of remaining tests in the container with the fewest remaining tests is equal to or greater than the number of tests planned by the automated QC. If the number of remaining tests is equal to or greater than the number of tests planned to be performed, the identified container, i.e., the container with the fewest remaining tests, is set in the rack. If the number of remaining tests is less than the number of tests planned to be performed, it is determined whether the total number of remaining tests (total remaining number of tests) obtained by adding together the remaining tests in the container with the fewest remaining tests and the other container with the second fewest remaining tests is equal to or greater than the number of tests planned to be performed.

[0283] If the combined remaining number of tests is equal to or greater than the number of tests to be performed, set those two QC sample containers 150 in the rack. If the combined remaining number of tests for the two QC sample containers 150 is less than the number of tests to be performed, add up the remaining number of tests for a third QC sample container 150 and repeat the same determination. If the combined remaining number of tests for all the QC sample containers 150 identified as available based on the lot number is still less than the number of tests to be performed, an automatic QC error is output and the schedule is canceled.

[0284] In case A, four tests are required for level 1, XN1 to XN4. Among the QC sample containers 150 at positions 1 and 2 identified based on the lot number, position 1 with the fewest remaining tests is used first. The remaining number of tests "3" of the QC sample container 150 at position 1 is compared with the number of tests to be performed "4". The remaining number of tests of the QC sample container 150 at position 1 is 3, which is less than the number of tests to be performed, 4, so there is one test shortage to perform quality control measurements at XN1 to XN4 with only the QC sample container 150 at position 1. Therefore, the total remaining number of tests "27", which is the sum of the remaining number of tests "24" of the QC sample container 150 at position 2, which has the second fewest remaining tests, and the remaining number of tests "3" of the QC sample container 150 at position 1, is compared with the number of tests to be performed "4". Since 27 tests is more than the number of tests to be performed, in this case, automatic QC errors are avoided, and the QC sample containers 150 in position numbers 1 and 2 are combined and set in the rack. In other words, the QC sample containers 150 in position numbers 1 and 2 are combined and a level 1 quality control measurement is performed.

[0285] In case A, four tests are also required for level 2, XN1 to XN4. The available QC sample containers 150 identified based on the lot number are the containers with position numbers 4 and 5. The number of remaining tests for the QC sample container 150 with position number 4 is seven, which is greater than the number of tests to be performed, which is four, so only the QC sample container 150 with position number 4 is sufficient. Therefore, the QC sample container 150 with position number 4 is set in the rack.

[0286] Therefore, in case A, the QC sample containers 150 at position numbers 1, 2, and 4 are combined and set in one rack.

[0287] <Case B> In Case B, the following QC conditions are set: Concentration level used: Level 2, 3 - Units subject to quality control measurement: XN1, XN2, XN3, XN4 ·Block straddling: Yes

[0288] For level 2, as in case A, four quality control measurements can be performed using only the QC sample container 150 at position number 4, so the QC sample container 150 at position number 4 is identified as the container to be used for the quality control measurements.

[0289] For level 3, only the QC sample container 150 at position number 8 is stored in the cold storage section 84. Since the number of remaining tests for the QC sample container 150 at position number 8 is 5, which is greater than the number of available tests of 4, the QC sample container 150 at position number 8 is identified as the container to be used for quality control measurements.

[0290] Therefore, in case B, the QC sample containers 150 at position numbers 4 and 8 are combined and set in one rack.

[0291] <Case C> In Case C, the following QC conditions are set: Concentration levels used: Levels 1, 2, 3 - Units subject to quality control measurement: XN1, XN2, XN3, XN4 ·Block straddling: Yes

[0292] In case C, the QC sample containers 150 at positions 1, 2, 4, and 8 are identified as containers to be used for quality control measurements by the algorithm described above for cases A and B. Thus, in case C, the four identified QC sample containers 150 are combined and set in one rack.

[0293] FIG. 47 shows cases D and E. <Case D> In Case D, the following QC conditions are set: Concentration level used: Level 1, 2 - Units subject to quality control measurement: XN1, XN2, XN3, XN4 · Block straddling: Not allowed

[0294] In case D, unlike case A, block crossing is set to "not allowed." In this case, the number of measurement blocks to which one QC sample rack 160 is transported is limited to one. In other words, a different QC sample rack 160 needs to be transported to each measurement block.

[0295] The QC sample containers 150 used for the quality control measurement of the first measurement block are set in the first QC sample rack 160. The QC sample containers 150 with two or more remaining tests are identified for each of level 1 and level 2, and are set in the first QC sample rack 160 in a combination. The same is true for the second QC sample rack 160. In case D, the combination of QC sample containers 150 with position numbers 1 and 4 is set in the first QC sample rack 160, and the combination of QC sample containers 150 with position numbers 2 and 5 is set in the second QC sample rack 160.

[0296] <Case E> In Case E, the following QC conditions are set: Concentration level used: Level 1, 2 - Units subject to quality control measurement: XN1, XN2, XN3, XN4 ·Block straddling: Yes Retest setting: Yes

[0297] Unlike Case A, Case E has an additional condition of "with retest." With retest means that retesting is automatically performed if retesting is required as a result of measuring a QC sample. Examples of situations where retesting is required include when the measurement value of a QC sample measured by the measurement unit falls outside the allowable range, or when the error from the previous value falls outside the allowable range.

[0298] In case E, it is assumed that when retesting is required as a result of quality control measurement by automatic QC, retesting is automatically performed up to once. In other words, it is assumed that one measurement unit performs measurement on one QC sample container 150 up to two times, including the initial test and the retest. After being taken out of the cooling section 84, the QC sample container 150 is heated in the heating section 86 for a certain period of time (e.g., 15 minutes) before being used. Therefore, when the number of remaining tests in the QC sample container 150 set in the rack is less than the number of tests required for retesting and retesting is required, it is necessary to take a new QC sample container 150 out of the cooling section 84 and heat it for a certain period of time, which causes a time loss. Therefore, in this embodiment, when "retest setting" is included in the QC conditions, the number of tests required for automatic retesting is included and the QC sample container 150 is set in the rack.

[0299] In case E, four measurement units, XN1 to XN4, are specified as targets. Therefore, for each concentration level, eight tests must be secured, including the initial test and retest. For level 1, the QC sample container 150 at position number 1 has three remaining tests, which is less than eight. Therefore, for level 1, the QC sample containers 150 at position numbers 1 and 2 are combined and set in the rack. For level 2, the QC sample container 150 at position number 4 has seven remaining tests, which is less than eight. Therefore, for level 2, the QC sample containers 150 at position numbers 4 and 5 are combined and set in the rack.

[0300] FIG. 48 shows case F. <Case F> In Case F, the following QC conditions are set: Concentration level used: Level 1, 2 - Units subject to quality control measurement: XN1, XN2, XN3, XN4 ·Block straddling: Yes Lot Difference Check: On

[0301] Unlike Case A, Case F has an additional condition of "lot difference check function on." The lot difference check function is a function that measures both the QC sample of the lot in operation and the QC sample of the new lot in one automatic QC schedule. When the lot of QC samples is switched, both the QC sample of the lot in operation and the QC sample of the new lot may be measured with the same measurement unit for a certain period (e.g., one week) to compare the quality control results of the two lots. In other words, there may be a certain overlap period between the usage period of the lot in operation and the new lot. This is done to confirm that there is no significant deviation between the lot in operation and the new lot. The lot difference check function is a function that automatically performs automatic QC using these two lots.

[0302] In case F, it is assumed that the QC sample list shown in FIG. 48 is stored in the database 820 of the control unit 82a. As shown in FIG. 48, for concentration level 1, QC sample containers 150 for lots P001 and P002 are stored in the cold storage unit 84. For level 1, P001 is the lot in operation, and P002 is a new lot. For level 2, QC sample containers 150 for lots Q001 and Q002 are stored. Q001 is the lot in operation, and Q002 is a new lot. In this case, one lot in operation and one new lot are combined for each concentration level.

[0303] In case F, for example, the QC sample containers 150 with position numbers 1 and 2 are combined on level 1, and the QC sample containers 150 with position numbers 4 and 5 are combined on level 2. That is, a QC sample rack 160 containing the QC sample containers 150 with position numbers 1, 2, 4, and 5 is transported to the measurement units XN1 to 4, and the four QC samples are measured in each measurement unit.

[0304] FIG. 49 is an example of a screen 3000 for comparing the quality control results of an old lot and a new lot. The screen 3000 is displayed, for example, on the monitor 92 (see FIG. 7) of the supply unit 80. The monitor 92 may be provided in another location, such as the measurement unit. The screen 3000 displays a QC chart 3001 for checking the daily variation of the measurement value of the QC sample as the quality control result. As shown in FIG. 49, by reading out the QC file of the old lot and the QC file of the new lot and performing an overlay operation, a QC chart 3002 of the old lot and a QC chart 3003 of the new lot can be displayed overlaid. The user can check the lot-to-lot difference in the quality control result by comparing and checking the two QC charts. By using the lot-to-lot difference check function of this embodiment, cumbersome lot switching can be performed smoothly.

[0305] Fig. 50 is a flowchart for explaining the processing of the supply unit 80 when a shutdown instruction is received. The control unit 82a judges whether or not a shutdown instruction has been received (step S700). As described with reference to Fig. 20, the control unit 82a of the supply unit 80 can receive a shutdown instruction from the user by pressing the OK button on the screens 2100 to 2103. When the OK button is pressed on any of the screens, the control unit 82a judges that a shutdown instruction has been received (YES in step S700).

[0306] The control unit 82a determines the shutdown mode selected by the user (step S701). When a shutdown is instructed via the designated device screen 2101 of FIG. 20, the control unit 82a determines that the mode is the designated device mode, and controls each part of the supply unit 80 to set the number of cleaning agent containers 180 corresponding to the number of devices designated on the screen 2101 in the rack and transport the cleaning agent rack toward the designated unit (step S702). The control of the supply unit 80 regarding the setting and transport of the cleaning agent is as described with reference to FIG. 34. The control of the measuring units 10A and 10B that have received the cleaning agent containers 180 is as described with reference to FIG. 39, and when cleaning using the cleaning agent is completed, the power of the units is automatically turned off. Although FIG. 39 illustrates the shutdown of the measuring unit, the power of the processing unit 40 is also automatically turned off after cleaning.

[0307] When the cleaning agent rack transported in step S702 returns, the control unit 82a controls each part of the supply unit 80 to store the rack in the rack storage unit 88 and discard the used cleaning agent container 180 (step S703), and ends the process. As a result, only the device designated by the user is shut down.

[0308] When an instruction to shut down the entire system is given via the system screen 2102 in FIG. 20, the control unit 82a determines that the entire system mode is selected, and controls each part of the supply unit 80 to transport a cleaning agent rack to all of the measurement units 10A, 10B and the processing unit 40 (step S704).

[0309] The control unit 82a controls each part of the supply unit 80 to store the returned detergent rack in the rack storage unit 88 and to discard the used detergent container 180 (step S705), similar to step S703. The control unit 82a transmits a command to turn off the power to all units of the sample analysis system 1 (step S706). This causes all devices constituting the sample analysis system 1 to be shut down.

[0310] In step S707, the control unit 82a turns off the power of the supply unit 80 and ends the process (step S707). However, as described above, the cooling unit 84 remains powered on even after the supply unit 80 is shut down, and the QC sample continues to be cooled and stored.

[0311] When an instruction to shut down the supply unit 80 alone is given via the screen 2103 in FIG. 20, the control unit 82a skips steps S702 to S706, executes the process of step S707, and ends the process.

[0312] As described above, according to the above-mentioned method for controlling the sample analysis system, one or more measurement units are started according to a schedule set by the user, and the quality control sample is automatically transported to the target measurement unit and measurement is started. Therefore, when performing quality control measurement, the user does not need to set the quality control material in the system, which reduces the burden on the user and greatly improves usability.

[0313] In addition to the above-described embodiments and modifications, the control method and sample analysis system according to the present invention can be modified in design as appropriate without impairing the object of the present invention.

[0314] 51 and 52 are schematic diagrams showing the configurations of sample analysis systems 1X and 1Y, which are first and second modified examples. As shown in FIG. 51, the sample analysis system 1X differs from the sample analysis system 1 in that the collection unit 60 is provided adjacent to the right side of the supply unit 80, opposite the module 10. In the case of the sample analysis system 1X, the rack transport path of the collection unit 60 is connected to the fifth transport path 815 of the conveyor section 81. The third transport path 23 and the fifth transport path 815 of the transport unit 20 were transport paths for collecting the QC sample rack 160 and the detergent rack in the sample analysis system 1, but are also used for collecting the sample rack 110 in the sample analysis system 1X.

[0315] As shown in FIG. 52, the sample analysis system 1Y is different from the sample analysis systems 1 and 1X in that an additional second supply unit 140 is provided adjacent to the right side of the supply unit 80. The second supply unit 140 is a unit in which the sample rack 110 and the like are set by the user, and does not have a cooling and storage function for the QC sample container 150. In the example shown in FIG. 52, the second supply unit 140 is disposed between the supply unit 80 and the recovery unit 60. The rack transport path of the second supply unit 140 is connected to the sixth transport path 819 of the conveyor section 81. In this case, the sixth transport path 819 functions as a transport path for carrying in the sample rack 110 and the like from the second supply unit 140.

[0316] 53 and 54 are diagrams showing a supply unit 80K which is a first modified example. The supply unit 80K includes a conveyor section 81K including a first transport path 811K on which a rack is set by a user. The configuration of the conveyor section 81K is the same as that of the supply unit 80. The supply unit 80K further includes a cold storage section 84K, a transfer section 85K, a heating section 86K, a rack storage section 88K, and a wagon 90K. Although a carousel-type cold storage section 84K is shown in FIG. 54, the configurations of these may be the same as those of the supply unit 80. In addition, configurations not shown, such as an information reading section 86, may also be the same as those of the supply unit 80.

[0317] The supply unit 80K has a structure of an input section 83K in which the QC sample container 150 and the detergent container 180 are set, which is different from the structure of the input section 83 of the supply unit 80. The input section 83K is disposed adjacent to the first transport path 811K and has a drawer-type structure that can slide in the front-rear direction of the supply unit 80K. The input section 83K has a first storage section 831K in which multiple QC sample containers 150 are set, and a second storage section 832K in which multiple detergent containers 180 are set. For example, three QC sample containers 150 can be set in the first storage section 831K.

[0318] The input section 83K is configured to be manually pulled out forward when the QC sample container 150 and the cleaning agent container 180 are set in the supply unit 80K. Alternatively, the input section 83K may be electrically operated. When the input section 83K is pulled out to the front of the device, the QC sample container 150 is set in the first storage section 831K, and the input section 83K is pushed to a predetermined position at the rear of the device, the transfer section 85K transfers the QC sample container 150 from the first storage section 831K to the cooling section 84K, as in the case of the supply unit 80. The cleaning agent container 180 is stored in the second storage section 832K. For example, a sensor that detects the number of cleaning agent containers 180 is installed in the supply unit 80K, and the number of cleaning agent containers 180 is displayed in a cleaning agent container inventory window 2006 shown in FIG. 19.

[0319] Fig. 55 is a schematic diagram of a supply unit 80X as a second modified example. As shown in Fig. 55, the supply unit 80X includes a first floor section 81X provided with a transport path 811X for transporting the sample rack 110 and the QC sample rack 160 to the measurement unit, and a second floor section 82X provided with a cooling section 84X, a cleaning agent container storage section 193, etc. Also includes a liftable moving section 190 for transporting the rack between the first floor section 81X and the second floor section 82X, and an information reading section 194 for reading the rack ID and the sample ID of the sample container 100, etc., from the rack moving on the moving section 190.

[0320] The second floor 82X is provided with a transport section 85X for gripping and transporting the QC sample container 150, and an information reading section 87X for reading the QC sample ID of the QC sample container 150, as in the case of the supply unit 80, and accommodates a plurality of empty racks 170 for accommodating and transporting the QC sample container 150 and the detergent container 180. The second floor 82X is also provided with a first input / recovery section 191 that functions as an input / recovery port for the QC sample container 150, and a second input / recovery section 192 that functions as an input / recovery port for the detergent container 180.

[0321] As described above, the QC sample container 150 is adjusted to the measurement temperature in the supply unit, and then placed in a rack and transported to the measurement unit. However, if only some of the multiple measurement units are in operation, it is preferable to transport the QC sample rack 160 only to the measurement units that are in operation, and not to any measurement units that are idle.

[0322] The control unit of the supply unit may also measure the time T1 during which the QC sample container 150 is taken out of the cold storage section 84 and placed in a room temperature environment, and execute a process of returning the QC sample container 150 to the cold storage section 84 when the time T1 exceeds a predetermined time T2. In this case, when the time T1 exceeds the time T2, the QC sample container 150 is returned to the cold storage section 84 without retesting, regardless of the measurement result of the QC sample, that is, even if the measurement result is abnormal when retesting is set as the QC condition. This process prevents the QC sample from being placed in a room temperature environment for a long period of time, and the condition of the QC sample can be maintained in good condition. Alternatively, the container may be discarded when the time T1 exceeds the predetermined time T2.

[0323] Furthermore, in the recovery process of the QC sample container 150, the control unit of the supply unit may determine whether the QC sample container 150 satisfies a predetermined continued use condition, and discard the QC sample container 150 that does not satisfy the continued use condition (for example, step S602 in FIG. 41). Alternatively, the QC sample container 150 that does not satisfy the continued use condition may be returned to the cooling unit 84 and kept in a cooled state as unusable. Since QC samples are expensive, it may be undesirable to automatically discard the QC sample container 150, and this configuration can meet this need.

[0324] The above-mentioned predetermined continued use conditions are conditions for determining whether the QC sample container 150 can be used in the next or subsequent quality control measurement, and include the remaining amount of the QC sample as well as the expiration date. For example, if the next quality control measurement is the next day, the QC sample container 150 whose expiration date is today may be discarded as it does not satisfy the continued use conditions.

[0325] In the above embodiment, the cooler 84 having a cooling function is exemplified as the storage of the supply unit for storing the QC sample container 150, but depending on the type of QC sample used, the storage may not have a cooling function. The heating unit that heats the QC sample to adjust it to the measurement temperature may be provided with devices that assist in heating, such as a stirrer, vibration generator, and rotating devices such as a carousel, in addition to a heater and a fan. The heating unit that heats the QC sample to adjust it to the measurement temperature may be provided with devices that assist in heating, such as a stirrer, vibration generator, and rotating devices such as a carousel, in addition to a heater and a fan.

[0326] In the above embodiment, the QC sample is heated by heating the QC sample container 150 by the heating means of the heating unit 86, but may be heated by exposing the QC sample container 150 to a room temperature atmosphere. In the above embodiment, the cooling unit 84 and the heating unit 86 are configured as separate devices and provided in separate locations, but it is also possible to use the cooling unit as the heating unit, for example. A Peltier element built into the cooling unit generally has not only a cooling function but also a heating function, so that when the above-mentioned predetermined condition is met, the Peltier element can be switched from the cooling mode to the heating mode to heat the QC sample.

[0327] In the above embodiment, a blood cell counter is exemplified as the measurement unit, but the measurement unit is not limited to this and may be a blood coagulation test, an immunological test, a biochemical test, etc. Furthermore, the sample supplied to the measurement unit is not limited to whole blood, but may be plasma, serum, urine, lymph, body cavity fluid, etc. [Explanation of symbols]

[0328] 1. Sample Analysis System 10 Modules 10A First Measuring Unit 10B Second measuring unit 20 Transport unit 21 First conveyor route 22 Second conveyor route 23 Third Transport Route 30 Control Unit 40 Processing Unit 50 Transport Unit 60 Recovery Unit 70 Transport Controller 80 Supply Units 81 Conveyor section 811 First conveyor route 812 Second conveyor route 813 Third Transport Route 814 4th Transport Route 815 5th Transport Route 819 6th Transport Route 82 Storage and Adjustment Unit 82a Control section 83 Insertion section 83A 1st input section 83B 2nd input section 830A,830B Transfer path 831A 1st input port 831B 2nd input port 832A 1st cover 832B 2nd cover 834 Transfer Holder 839 Removal section 84 Refrigeration section 85 Transfer section 86 Heating section 87 Information reading unit 88 Rack storage area 89A First Recovery Section 89B 2nd Recovery Section 90 Wagon 91 Monitor 100 specimen containers 110 Sample Rack 120 Host Computer 130 Concentrator 150 QC sample containers 160 QC Sample Racks 170 Empty Rack 180 Detergent container

Claims

1. A method for controlling a sample analysis system including a plurality of devices for processing samples, comprising: accepting designation of one or more devices from a user; shutting down the specified device.

2. 10. The method of claim 1, wherein shutting down the device includes automatically powering off after cleaning the device with a cleaning solution.

3. The method of claim 2 , wherein shutting down an apparatus includes transporting the cleaning fluid from a unit storing the cleaning fluid to one or more designated apparatuses.

4. The method of claim 2 or 3, further comprising displaying an inventory of said cleaning fluid.

5. The method according to any one of claims 1 to 4, further comprising displaying an apparatus selection screen that selectively accepts designation of the plurality of apparatuses included in the sample analysis system.

6. and displaying a mode selection screen for selecting a first mode for shutting down a designated device and a second mode for shutting down the entire sample analysis system; When the first mode is selected, the device selection screen is displayed and a device designation is accepted; The method of claim 5 , further comprising shutting down all devices included in the sample analysis system when the second mode is selected.

7. A plurality of devices for processing the specimen; A control unit; Equipped with The control unit receives designation of one or more devices from a user and shuts down the designated device(s).

8. The sample analysis system according to claim 7 , wherein the control unit shuts down one or more designated devices after cleaning the device with a cleaning solution.

9. The sample analysis system according to claim 8 , wherein the control unit, upon receiving a command to shut down one or more devices, transports the cleaning liquid from a unit that stores the cleaning liquid to the specified one or more devices.

10. Further comprising a monitor; The sample analyzing system according to claim 8 , wherein the control unit displays inventory information of the cleaning liquid on the monitor.

11. Further comprising a monitor; The sample analysis system according to any one of claims 7 to 10, wherein the control unit causes the monitor to display an apparatus selection screen that selectively accepts designation of the plurality of apparatuses included in the sample analysis system.

12. The control unit is displaying on the monitor a mode selection screen for selecting between a first mode for shutting down a designated device and a second mode for shutting down the entire sample analysis system; When the first mode is selected, the device selection screen is displayed on the monitor and a device is designated; The sample analysis system of claim 11 , wherein when the second mode is selected, all devices included in the sample analysis system are shut down.

Citation Information

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