Method for controlling accuracy of sample analysis system and sample analysis system

Abstract

To provide a method for managing the accuracy of a specimen analysis system that is highly reliable and reduces a workload on a user.SOLUTION: A method for managing the accuracy of an analyzer being an example of an embodiment is a method for managing the accuracy of a specimen analysis system comprising an analyzer analyzing a specimen including tissue-derived cells. When a container containing an accuracy control substance including cells with a known concentration is placed on an introduction unit of the specimen analysis system, the method transfers the container from the introduction unit to a cold reserving unit to cool and store the container. When measuring the accuracy control substance with the analyzer, the method heats the container being cooled and stored to adjust the temperature of the accuracy control substance to a measurement temperature and conveys the container containing the accuracy control substance whose temperature is adjusted to the measurement temperature to the analyzer.SELECTED DRAWING: Figure 8

Description

[Technical Field]

[0001] The present invention relates to a quality 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 of biological origin, such as blood cells, have been widely known. In such systems, it is necessary to periodically check the measurement results of the analyzer for abnormalities using a quality control material containing cells of known concentrations, thereby managing the measurement accuracy.

[0003] In the device of Patent Document 1, when a sample rack containing a container containing a quality control material is set in the device, the device reads the identification information attached to the container and, if the information indicates that a preparation process should be performed, performs a preparation process for the quality control material. The sample rack is then transported to a storage unit with constant temperature and humidity functions, where the prepared quality control material is temporarily stored until measurement begins. The preparation process for the quality control material is performed based on a preparation protocol that defines processing conditions such as waiting time before dissolution, waiting time after dissolution, and standing time after stirring. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] Japanese Patent Application Laid-Open No. 2013-024691 Summary of the Invention [Problem to be solved by the invention]

[0005] Generally, quality control materials are stored in a refrigerator, and are removed from the refrigerator and measured before the start of routine specimen testing in the laboratory. In the device of Patent Document 1, the temperature of the quality control materials is adjusted by storing the rack set by the user in a storage unit for a certain period of time, so the user must arrive at the laboratory early enough to allow for the time required for temperature adjustment, remove the quality control materials from the refrigerator, set them in the sample rack, and set the sample rack in the device. This leaves room for improvement in terms of reducing the burden on the user.

[0006] The present invention aims to reduce the burden on users associated with measuring quality control samples. [Means for solving the problem]

[0007] The quality control method for a sample analysis system of the present invention is a quality control method for a sample analysis system equipped with a cooling section and a heating section, in which a container containing a quality control material containing cells of a known concentration is stored cool in the cooling section, the container is removed from the cooling section by a transfer section that holds and transfers the container, the removed container is transferred to the heating section, the heated container is transported to the analytical device, and the quality control material is measured by the analytical device.

[0008] The sample analysis system of the present invention is a sample analysis system equipped with an analytical device for analyzing samples, and includes a cooling unit that cools and stores containers containing quality control materials including cells of known concentrations, a heating unit that heats the quality control materials, a transport unit that holds and transports the containers from the cooling unit to the heating unit, and a transport unit that transports the containers containing the heated quality control materials to the analytical device. [Effects of the Invention]

[0009] According to the present invention, it is possible to provide a quality control method for a sample analysis system and a sample analysis system that can reduce the burden on the user associated with measuring quality control samples. [Brief explanation of the drawings]

[0010] [Figure 1] FIG. 1 is a diagram illustrating a sample analysis system. [Figure 2] FIG. 1 is a diagram illustrating a sample analysis system. [Figure 3] 1 is a block diagram showing the interconnection relationships of the units that make up the sample analysis system. FIG. [Figure 4] FIG. 2 is a perspective view showing a sample container and a sample rack in which the sample containers are accommodated. [Figure 5] FIG. 2 is a diagram schematically illustrating the configuration of a measurement unit and a transport unit that make up the sample analysis system. [Figure 6] FIG. 2 is a diagram schematically illustrating the configuration of a measurement unit and a transport unit. [Figure 7] FIG. 2 is a perspective view of a supply unit that constitutes the sample analysis system. [Figure 8] FIG. 2 is a diagram schematically illustrating the configuration (internal layout) of the supply unit, showing a state in which a sample rack is set on a conveyor section. [Figure 9] FIG. 10 is a perspective view of an input section constituting the supply unit, showing a state in which a QC sample container is set in the input port. [Figure 10] FIG. 10 is a perspective view of the input section, showing a state in which a QC sample container has been transported into the storage adjustment unit. [Figure 11] FIG. 10 is a perspective view of the cooling unit constituting the supply unit, showing a state in which the cover is closed. [Figure 12] FIG. 10 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. 10 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. 10 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. 1 is a diagram schematically illustrating the configuration (internal layout) of a supply unit according to an embodiment, showing how a QC sample rack is supplied. [Figure 17] FIG. 10 is a diagram schematically illustrating the configuration (internal layout) of a supply unit according to an embodiment, showing how a QC sample rack is being collected. [Figure 18] 10 is an example of a home screen displayed on a monitor of a supply unit. [Figure 19] 10 is an example of a device status screen that is displayed when a device status icon on the home screen is pressed. [Figure 20] 10 is an example of a shutdown screen that is displayed when a shutdown icon on the device status screen is pressed. [Figure 21] 10 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] 10 is an example of an input screen that is displayed when an input icon on the device status screen is pressed. [Figure 23] 10 is an example of a schedule screen that is displayed when a schedule icon on the home screen is pressed. [Figure 24] 10 is an example of a schedule registration screen that is displayed when a registration icon on the schedule screen is pressed. [Figure 25] 10 is an example of a confirmation screen that is displayed when an automatic QC schedule is entered and the OK button is pressed on the schedule registration screen. [Figure 26] 10 is an example of an operation menu that is displayed when a schedule list on a schedule screen is pressed. [Figure 27] 10 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 showing the connection relationship between the supply unit, the measurement unit, and a transport controller. [Figure 29] 10 is an example of a database of QC samples stored in the control unit of the supply unit. [Figure 30] 1 is a flowchart showing a series of processes in a sample analysis system. [Figure 31]10 is a flowchart showing the procedure of an automatic wake-up process. [Figure 32] 10 is a flowchart showing the procedure of automatic QC in the supply unit. [Figure 33] 10 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. [Figure 34] 10 is a flowchart showing the procedure of automatic cleaning in the supply unit. [Figure 35] 10 is a flowchart showing the procedure of a process for storing a QC sample container in a refrigerated section of a supply unit. [Figure 36] 10 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] 10 is a flowchart showing the measurement procedure of 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. [Figure 40] 10 is a flowchart showing the processing procedure for transporting and storing racks. [Figure 41] 10 is a flowchart showing a processing procedure for collecting racks. [Figure 42] FIG. 10 is a diagram showing the operation of a supply unit in automatic QC. [Figure 43] 10A and 10B are diagrams illustrating the operation of the supply unit in automatic cleaning. [Figure 44] 10A and 10B are diagrams showing the operation of the supply unit when storing a QC sample container in a refrigerated section. [Figure 45] 10A and 10B are diagrams illustrating the operation of the supply unit when an empty rack is accommodated in the rack accommodating section. [Figure 46] FIG. 10 is a diagram showing a specific example of a combination of QC sample containers. [Figure 47] FIG. 10 is a diagram showing a specific example of a combination of QC sample containers. [Figure 48]FIG. 10 is a diagram showing a specific example of a combination of QC sample containers. [Figure 49] 10 is an example of a screen for comparing the quality control results of an old lot and a new lot, which is displayed on the monitor of the sample analysis system. [Figure 50] 10 is a flowchart illustrating processing of the supply unit when a shutdown instruction is received. [Figure 51] FIG. 1 is a diagram schematically illustrating the configuration of a first modified example of a sample analyzing system. [Figure 52] FIG. 10 is a diagram schematically illustrating the configuration of a second modified example of the sample analyzing system. [Figure 53] FIG. 10 is a perspective view showing the appearance of a first modified example of the supply unit. [Figure 54] FIG. 10 is a diagram schematically illustrating the configuration of a first modified example of a supply unit. [Figure 55] FIG. 10 is a diagram schematically illustrating the configuration of a second modified example of the supply unit. DETAILED DESCRIPTION OF THE INVENTION

[0011] An example of an embodiment of a quality control method for a sample analysis system and a sample analysis system according to the present invention will be described in detail below with reference to the drawings. The embodiment described below is merely an example, and the present invention is not limited to the following embodiment. Furthermore, selective combinations of the components of the multiple embodiments and variations described below are also included within the scope of the present invention.

[0012] 1 and 2 are diagrams schematically illustrating the overall configuration of a sample analysis system 1, which is an example of an embodiment. As shown in FIGS. 1 and 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 that analyze samples containing cells of biological origin, and are arranged adjacent to each other. Hereinafter, the two measurement units that make up the analyzer are collectively referred to as the "measurement block." The transport unit 20 is arranged in front of the measurement block. For ease of explanation, terms indicating directions such as front-rear, left-right, and up-down shown in the drawings are used in this specification.

[0013] 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 is provided with one control unit 30 for each of the 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.

[0014] The sample analysis system 1 includes a supply unit 80, upstream of the two modules 10, on which a sample rack 110 is set. 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, which is disposed upstream. The supply unit 80 includes a conveyor unit 81 for transporting the sample rack 110 to the module 10. In this embodiment, the sample rack 110 is set on the conveyor unit 81 by a user.

[0015] The conveyor unit 81 is connected to the transport unit 20 of the module 10 and is configured to be able to transfer the set sample rack 110 to the transport unit 20. As will be described in detail below, in addition to the sample containers 100, the supply unit 80 is set with QC sample containers 150 containing quality control material containing cells of known concentrations. The supply unit 80 is equipped with a storage adjustment unit 82 that cools and stores the QC sample containers 150 and adjusts the temperature of the quality control material to the measurement temperature before sending them to the conveyor unit 81. The QC sample containers 150 contain 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. Hereinafter, the amount corresponding to one measurement will also be referred to as "one test."

[0016] The upstream side of the sample analysis system 1 refers to the side where the sample rack 110 is set and serves as the starting point for transport, i.e., the side where the supply unit 80 is located. 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 paper is the upstream side of the sample analysis system 1, and the left side of the paper 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 handed over to the measurement unit by the function of the transport unit 20.

[0017] The transport unit 20 has multiple rack transport paths and is able to distribute and supply sample containers 100 to the first measurement unit 10A and the second measurement unit 10B. The transport unit 20 has a first transport path 21 for receiving sample racks 110 from the upstream side (right side) of the sample analysis system 1 and transporting them to the downstream side (left side), and a second transport path 22 that extends parallel to the first transport path 21 and is positioned closer to the measurement block than the first transport path 21. The second transport path 22 transports the sample racks 110 in the left-right direction. The second transport path 22 has a take-out position P2 (see FIG. 5, etc., described below) where the sample container 100 is taken out of the sample rack 110 and taken into the measurement unit.

[0018] 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 further forward in the sample analysis system 1 than the first transport path 21. That is, the transport unit 20 has three rack transport paths aligned in the front-to-rear direction, in the order from the front: the third transport path 23, the first transport path 21, and the second transport path 22. As will be described in more detail below, the third transport path 23 is configured to transport racks from the downstream side to the upstream side of the sample analysis system 1. Therefore, when viewing the third transport path 23 alone, the left side is the upstream side of the transport path and the right side is the downstream side of the transport path.

[0019] 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.

[0020] The transport unit 50 is provided with 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. If 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, passing through the processing unit 40.

[0021] 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 collection unit 60, with adjacent units connected to each other. The sample analysis system 1 is also formed with a continuous rack transport path that can transport sample racks 110 in the left-right direction from the supply unit 80 to the collection 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.

[0022] In the sample analysis system 1, the measurement block and transport unit 20 are placed on a wagon 18. The wagon 18 stores reagent containers 19 containing reagents used in the measurement units. Similarly, wagons 90 are provided for the processing unit 40, transport unit 50, recovery unit 60, and supply unit 80. It is preferable that the wagons 18, 51, 61, and 90 have the same height or be adjustable 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 transport unit 50 are placed also stores reagent containers 52 containing reagents such as staining solution.

[0023] The sample analysis system 1 further includes a transport controller 70 for managing the transport of the sample racks 110 and the QC sample racks 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 sending and receiving signals to and from the transport units 20, 50, 81, the recovery unit 60, and the supply unit 80. In the sample analysis system 1, each unit and the transport controller 70 are communicatively connected to a host computer 120 via a communication network.

[0024] 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.

[0025] In this specification, a rack that does not contain any containers is referred to as an empty rack 170 (see FIG. 8, etc., described later). An empty rack 170 containing sample containers 100 is referred to as a sample rack 110. An empty rack 170 containing QC sample containers 150 is referred to as a QC sample rack 160.

[0026] 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 an upstream module 10, the sample rack 110 is transported by the first transport path 21 to the transport unit 20 of the downstream module 10. If the destination is an upstream module 10, the sample rack 110 is transported from the first transport path 21 to the second transport path 22 of that module 10, where an initial test and, if necessary, a retest are performed in the measurement block of that module 10. The control unit 30 is configured to transmit the results of the initial test and the retest to a host computer 120.

[0027] When the initial test and any necessary retests have been completed for all of 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 sample needs to be prepared in the processing unit 40 for each sample container 100. If the sample rack 110 includes a sample container 100 for which a smear sample 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.

[0028] If the sample rack 110 does not contain any sample containers 100 that require the preparation of a smear sample, 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 to be prepared in the processing unit 40, the sample rack 110 is transported to the collection unit 60 after the smear sample has been prepared.

[0029] Figure 3 is a block diagram showing the connection relationships of the units that make up the sample analysis system 1. As shown in Figures 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 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.

[0030] 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 parts related to rack transport on the first transport path 21 and the third transport path 23. The second transport mechanism 20b includes parts related to rack transport on 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.

[0031] 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 memory unit, and an input / output interface. The processor is, for example, a CPU, and controls the operation of each component of the measurement unit and the transport unit by reading and executing a control program installed in the memory unit. The processor further executes an analysis program installed in the memory unit to analyze the measurement data transmitted from the measurement unit and count or quantify blood components contained in the sample, such as red blood cells, white blood cells, platelets, and hemoglobin. The memory unit includes non-volatile memory such as ROM, HDD, or SSD, and volatile memory such as RAM. The control unit 30 is connected to the measurement unit and the transport unit via a LAN cable.

[0032] Each unit constituting the sample analysis system 1 is communicatively connected via a concentrator 130. The concentrator 130 is configured, for example, by a hub. In this embodiment, the first transport mechanism 20a, transport unit 50, collection unit 60, transport controller 70, and 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 units based on the acquired measurement order.

[0033] 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 memory unit incorporated in the processing unit 40, and controls the preparation unit 42 based on a control program installed in the memory unit. The preparation unit 42 is configured to aspirate the sample from the sample container 100 and prepare a smear sample when the sample 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 operation of the preparation unit 42 is controlled by the control unit 41. The collection unit 60 collects sample racks 110 for which measurement has been completed in either of the two modules 10, and sample racks 110 for which smear sample preparation 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.

[0034] 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 collection unit 60 via the concentrator 130, and controls the transport of the sample racks 110 and the QC sample racks 160. The control unit 71 is communicably 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 detection signals from the sensors of each unit.

[0035] 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 control unit 82a also functions to automatically wake up and shut down 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.

[0036] 4 is a perspective view showing a sample rack 110 containing 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 sample rack 110 is referred to as the rear side of the sample rack 110.

[0037] As shown in FIG. 4, the sample container 100 comprises a bottomed tube 101 containing a blood sample 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, sealing the internal space that contains the sample. The sample 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 sample ID is printed, and is affixed to the side of the tube 101. The sample ID is identification information that can individually identify the sample.

[0038] The sample rack 110 (empty rack 170) is a case that stores sample containers 100 and is used for transporting the sample containers 100, and includes a plurality of storage sections 111 that can hold a plurality of sample containers 100 in an upright position. The number of storage sections 111 is not particularly limited, but in this embodiment, ten storage sections 111 (numbered 1 to 10) are formed in a row 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 the rack ID is printed. The rack ID is identification information that can individually identify the sample rack 110.

[0039] The sample rack 110 includes a bottom plate 113 that is rectangular in bottom view, and a wall 114 that extends in the height direction of the sample containers 100 and supports the sample containers 100. In the sample rack 110, the sample containers 100 stand upright approximately perpendicular to the bottom plate 113. The wall 114 is formed at a height lower than the upright sample containers 100. The wall 114 includes a pair of side walls 115 formed on 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 toward the rear end of the bottom plate 113. The plurality of partitions 117 divide the storage space for the sample containers 100, forming a plurality of storage sections 111 (ten in FIG. 4 ).

[0040] The rack illustrated in FIG. 4 has nine partitions 117, and a machine-readable label 112, which is a barcode label, is affixed 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 facing upward and backward. Therefore, the machine-readable label 103 can be read even when the sample container 100 is stored in the storage section 111. Note that the machine-readable labels 103, 112 are not limited to one-dimensional barcode labels as shown in FIG. 4, but may also be two-dimensional codes. The machine-readable labels 103, 112 may also be IC tags that can be read by an RFID reader.

[0041] The configuration of the measurement block and the transport unit 20 will be described in detail below with reference to Figures 5 and 6. In Figure 5, the plate 272 of the first send-out section 27A is in a position retracted from the first transport path 21, and in Figure 6, the plate 272 is present on the first transport path 21.

[0042] [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 arranged adjacent to the transport unit 20 in the front-to-rear direction and behind the transport unit 20. The first measurement unit 10A and the second measurement unit 10B take out sample containers 100 from sample racks 110 transported to the second transport path 22 of the transport unit 20 and measure the blood samples contained in the sample containers 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.

[0043] The first measurement unit 10A can measure, for example, CBC items and DIFF items. 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), and PLT (platelet count). DIFF items include NEUT# (neutrophil count), LYMPH# (lymphocyte count), MONO# (monocyte count), EO# (eosinophil count), and BASO# (basophil count). The second measurement unit 10B can measure, for example, RET items, PLT-F items, and WPC items in addition to CBC and DIFF items. RET items include RET# (reticulocyte count), and PLT-F items include PLT# (platelet count). The WPC item detects and flags abnormal white blood cells, for example, blasts and lymphocytes.

[0044] 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, if necessary, measures the RET, PLT-F, or WPC items as a retest. That is, the first measurement unit 10A is a measurement unit dedicated to initial tests, and the second measurement unit 10B is a measurement unit capable of performing retests in addition to initial tests.

[0045] The first measurement unit 10A comprises a container transporter 11, an information reader 12, a sample preparation unit 13, and a measurement unit 14. The first measurement unit 10A comprises a robot hand 15 that removes a sample container 100 from a storage unit 111 of a sample rack 110 at a predetermined removal position P2 of the second transport path 22, shakes the removed sample container 100 a predetermined number of times to mix it by inverting, and places the mixed sample container 100 in the container transporter 11. The container transporter 11 has a holder 11a that can hold the sample container 100 in an upright position, and is configured so that the holder 11a moves back and forth together with the container transporter 11. The information reading unit 12 is positioned on the transport path of the specimen container 100 by the container transport unit 11, at a position between the installation position where the specimen container 100 is installed by the robot hand 15 and the suction position by the suction tube 13a described below, and reads the specimen ID from the machine-readable label 103 of the specimen container 100 set in the holder 11a.

[0046] 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 with a reagent in the reaction vessel. The reagent is, for example, a diluent, a hemolytic agent, or 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 measures the measurement sample. After the sample has been aspirated, the sample container 100 is transported forward by the container transfer unit 11 and returned to its original storage unit 111 in the sample rack 110 by the robot hand 15.

[0047] The first measuring unit 10A, the second measuring unit 10B, and the second transport mechanism 20b (see FIG. 3), which is part of the transport unit 20, are controlled by the control unit 30. When performing a primary test, the control unit 30 queries the host computer 120 about a measurement order for the primary 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 determining whether or not to perform a retest based on the measurement results of the primary test, and when it is determined to perform a retest in accordance with the rules, generates a measurement order for the retest.

[0048] During an initial test, the sample containers 100 stored in the sample rack 110 are sequentially loaded into the first measurement unit 10A or the second measurement unit 10B, starting 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-numbered storage position numbers shown in Figure 4 are loaded into the second measurement unit 10B, and the sample containers 100 with even-numbered storage position numbers are loaded into the first measurement unit 10A.

[0049] [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 and right, from right to left and left to right.

[0050] 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 material that will be used for multiple measurements, and since the quality control material needs to be stored refrigerated 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, used sample racks 110 are transported to the collection unit 60, so the third transport path 23 does not transport sample racks 110.

[0051] The transport unit 20 is provided with movable stoppers 21c and 23b at the downstream end of the first transport path 21 and the downstream end of the third transport path 23, respectively. 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-to-rear direction with a second reservoir 25 (described later). Below, the configuration of the transport unit 20 will be explained using 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.

[0052] The first transport path 21, the second transport path 22, and the third transport path 23 are arranged at a distance from each other in the front-to-rear direction. A first storage section 24 and a second storage section 25, which are spaces capable of storing 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.

[0053] 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 also includes an information reading unit 26 that reads 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 positioned so as to be able to read the machine-readable labels 103, 112 between the right-side removal position P2 corresponding to the first measurement unit 10A and the left-side removal position P2 corresponding to the second measurement unit 10B.

[0054] The transport unit 20 includes rack output sections: a first output section 27A, a second output section 27B, a third output section 27C, and a fourth output section 27D. All four rack output sections are rack transport devices configured to be movable in the front-to-rear direction. The first output section 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 output section 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 output section 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 output section 27D transports the sample rack 110 from the second storage section 25 to a downstream position of the first transport path 21.

[0055] The transport unit 20 is provided with four sensors 28a, 28b, 28c, and 28d that detect the sample racks 110 on the first transport path 21 and the second transport path 22. The transport unit 20 is also provided with sensors 28e and 28f that detect the sample racks 110 on the third transport path 23. The transport unit 20 is also provided with sensors 28g, 28h, and 28i that detect the sample racks 110 in the first storage section 24 and the second storage section 25.

[0056] Below, each component of the transport unit 20 will be described along the transport path of the sample rack 110. Note that in Figures 5 and 6, 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.

[0057] 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 independently driven 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.

[0058] The transport of the sample rack 110 on the first transport path 21 is performed under the control of the transport controller 70. Specifically, the transport controller 70 transmits control signals to stepping motors connected to the transport belts 21a and 21b, and the motors are driven based on these control signals. Note that the transport of the sample rack 110 on the other transport paths and rack output units is also performed under the control of the transport controller 70 or the control unit 30.

[0059] The sample rack 110, which is transported from the supply unit 80 to an upstream position on 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 unit 24 by the first sender 27A. The sensor 28a is, for example, an optical sensor having a light-emitting unit and a light-receiving unit, and the light-emitting unit and the light-receiving unit are arranged to 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 unit is blocked by the sample rack 110, causing a decrease in the light reception level of the light-receiving unit. Note that optical sensors similar to the sensor 28a can also be used for other sensors installed in the transport unit 20.

[0060] The first sender 27A, which is provided at an upstream position of the first transport path 21, has a plate 271 extending along the length of the first transport path 21 and a plate 272 extending along the width of the first transport path 21 as engagement parts that engage with the sample rack 110. The plates 271 and 272 are, for example, connected to each other and arranged in a generally L-shape in plan view. The first sender 27A is configured to be movable in the front-rear direction between a retracted position (see FIG. 5) where the plates 271 and 272 do not interfere with the transport of the sample rack 110 along the first transport path 21, a stop position (see FIG. 6) where the sample rack 110 being transported along the first transport path 21 is stopped, and a position where the sample rack 110 is pushed out into the first reservoir 24.

[0061] 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 on the plate 272 and stopped. 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 arranged to sandwich the first storage section 24 from the left and right.

[0062] The first storage unit 24 is a space for storing the sample rack 110 received from the first transport path 21, and is configured, for example, by placing a plate-like member with its upper surface 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 unit 24 is detected by a sensor 28g and 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 portion 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, thereby pushing 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.

[0063] The second transport path 22 includes two transport belts 22a and 22b that transport the sample rack 110 independently in the left-right direction. The transport belts 22a and 22b are independently driven 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 has two protrusions 22c between which the sample rack 110 fits. The transport belt 22b also has two protrusions 22d between which the sample rack 110 fits. The sample rack 110 is sent to the second sender 27B so as to fit between these protrusions 22c. The sample rack 110 is transported left-right by the drive of the transport belts 22a and 22b while fitted between the protrusions 22c.

[0064] The second transport path 22 allows two sample racks 110 to be transported separately in the left-right direction. As shown in Figure 6, two sample racks 110 can be simultaneously loaded onto 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 on the leading rack, measurements can also be performed on the following rack in parallel.

[0065] The information reading unit 26 includes rollers 26a and 26b and a reading unit 26c, which are arranged to sandwich the second transport path 22 between them. The rollers 26a and 26b can move toward each other, and the roller 26a rotates while sandwiching the sample container 100 in the front-to-back direction. This causes the sample container 100 to rotate. The reading unit 26c reads the machine-readable label 103 of the rotating sample container 100 through the gap between the rollers 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 in the measurement unit are performed under the control of the control unit 30.

[0066] The sample container 100, whose sample ID has been read, is transported to removal position P2 corresponding to either the first measurement unit 10A or the second measurement unit 10B, where it is removed from the sample rack 110 by the robot hand 15 and loaded into the measurement unit. At this time, the measurement unit that loads the sample container 100 is determined so that the load on each measurement unit is distributed. An initial test is performed in the measurement unit, and when the initial test is completed, the sample container 100 is returned to its original storage section 111 at removal position P2. When the initial test and any necessary retests have been completed for all of 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 transported to the second storage section 25 by the third output section 27C.

[0067] Even if the initial inspection of all the sample containers 100 in the leading rack has been completed, the leading rack must remain on the second transport path 22 until it is determined whether or not retesting is required for all the sample containers 100. At this time, since it takes a certain amount of time to determine whether or not retesting is required for the sample container 100 that was last subjected to the initial inspection, in order to improve 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 retracted to the left end position of the second transport path 22 so as not to interfere with the transport of the following rack.

[0068] A sensor 28d is installed near the left end position of the second transport path 22. After the initial test and all necessary retests have been completed, the sample rack 110 is pushed from the left end position by the third output unit 27C to the second storage unit 25 provided in front of it. The second storage unit 25 is a space for storing the sample rack 110 received from the second transport path 22, and similar to the first storage unit 24, is configured by arranging plate-like members whose upper surfaces are parallel to the horizontal plane. The sample rack 110 in the second storage unit 25 is detected by sensors 28h and 28i, and is pushed to the first transport path 21 at an appropriate time by the fourth output unit 27D.

[0069] The rack in the second storage section 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.

[0070] For example, if the rack in the second storage section is a sample rack 110 containing sample containers 100 and its next destination is the processing unit 40 or the collection 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 QC sample containers 150 and its 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.

[0071] When a rack in second storage unit 25 is to be transported to first transport path 21, fourth sending unit 27D pushes the rack forward with stopper 21d raised to a position higher than the belt of first transport path 21. The rack pushed forward hits stopper 21d and stops at a downstream position on first transport path 21. When stopper 21c is lowered and transport belt 21b is driven, the rack is transported leftward.

[0072] When a rack in the second storage unit 25 is to be 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 that is the same as 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 on the third transport path 23.

[0073] The third transport path 23 includes a transport belt 23a. The transport belt 23a is driven by a stepping motor, similar to the above-described transport belts 21a and 21b. The rack transported to the third transport path 23 is transported rightward by the transport belt 23a.

[0074] [Supply Unit 80] The configuration of the supply unit 80 will be described in detail below with reference to FIGS.

[0075] As described above, the supply unit 80 is a device for supplying sample racks 110 containing sample containers 100 to the measurement units. The supply unit 80 also cools and stores QC sample containers 150 containing quality control materials, and adjusts the temperature of the quality control materials to a measurement temperature according to a schedule pre-registered by the user. The QC sample containers 150 containing the temperature-controlled quality control materials are then set in a rack and transported to the target measurement unit. The QC sample containers 150 are placed in an empty rack 170, and, like the sample rack 110, are transported to the second transport path 22 of the transport unit 20 as QC sample racks 160 containing the QC sample containers 150.

[0076] The QC sample container 150 differs from the sample container 100 in that it contains a quality control material containing cells of a known concentration. Like the sample container 100, the QC sample container 150 includes a tube 101 and a cap 102. A machine-readable label 103 indicating the sample ID, including the lot number, concentration level, and expiration date of the QC sample, is attached to the side of the tube 101. The machine-readable label 103 is a barcode label. Note that the QC sample container 150 may be a container with a different shape from the sample container 100, and two or more types of containers may be used for each of the sample container 100 and the QC sample container 150.

[0077] Quality control materials are also commonly referred to as control samples or QC samples. In the sample analysis system 1, the quality control materials must be used periodically to check for abnormalities in the measurement results of the analyzer and to control the measurement accuracy. For example, once a day, before starting sample measurement, the sample analysis system 1 transports QC sample containers 150 to the first measurement unit 10A and second measurement unit 10B, which are the analyzers, and measures the quality control materials. The measurement values ​​of the quality control materials, such as the red blood cell count, white blood cell count, platelet count, and hemoglobin concentration, are compared with upper and lower limit values ​​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 and lower limit range, the quality control results are determined to be normal; if it is outside the range, the quality control results are determined to be abnormal.

[0078] The quality control material is control blood suitable for quality control of an automated blood cell counter, and includes whole blood components adjusted to known concentrations. Examples of whole blood components include blood cells, including red blood cells, white blood cells, and platelets. An example of such a quality control material is XN-CHECK (manufactured by Sysmex Corporation). The quality control material may include three types of quality control material adjusted to three concentration levels: low concentration, standard concentration, and high concentration. Hereinafter, the low-concentration quality control material will be referred to as Level 1, the standard-concentration quality control material as Level 2, and the high-concentration quality control material as Level 3.

[0079] 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 with different concentration levels.

[0080] 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 surface of the supply unit 80, there are provided 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.

[0081] The first cover 832A covers the entire first insertion port 831A and is opened and closed by the user. The first cover 832A is configured, for example, such that the left end is rotatably supported on the housing and rotates 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. As will be described in detail later, the QC sample container 150 is set in the transfer holder 834.

[0082] The supply unit 80 further includes a second opening 831B into which the cleaning agent container 180 (see FIG. 8, etc.) is set, and a second cover 832B that covers the second opening 831B. The second opening 831B is disposed adjacent to the right side of the first opening 831A. The second cover 832B is configured such that, for example, its rear end is rotatably supported on a shaft relative to the housing and can be rotated upward to open.

[0083] 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 about the state of the supply unit 80, including information about 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.

[0084] 8 is a diagram showing a schematic internal layout of the supply unit 80. The supply unit 80 includes, as its 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 storage section 88. In the following explanation, the contents common to the transport of the sample rack 110 and the transport of the QC sample rack 160 will be explained using the transport of the sample rack 110 as an example.

[0085] [Conveyor section 81] The conveyor unit 81 includes multiple rack transport paths that transport the sample racks 110 within the supply unit 80. The conveyor unit 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 a sample rack 110 set on 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.

[0086] 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 that 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 further forward of the conveyor section 81 than the fourth transport path 814. The fifth transport path 815 is a rack transport path that returns the QC sample rack 160 to the storage adjustment unit 82 and is connected to the first transport path 811.

[0087] The conveyor unit 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 transport the sample rack 110 from the additional supply unit. The sixth transport path 819 is provided with a transport belt 819a that transports the sample rack 110 from right to left. A sensor 819b that detects the sample rack 110 is installed near the left end position of the sixth transport path 819.

[0088] 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 front to rear, and the third transport path 813 is a transport path for transporting the sample rack 110 from rear to front. The second transport path 812 is provided extending in the left-right direction, with the right end of the second transport path 812 aligned with the rear end of the first transport path 811 and the left end of the second transport path 812 aligned with the rear end of the third transport path 813. With this configuration, the second transport path 812 can receive racks sent out from the first transport path 811 and transport them in the left-right direction. The third transport path 813 can receive racks transported to the left end by the second transport path 812.

[0089] The first transport path 811 and the third transport path 813 are formed long in the front-rear direction and can simultaneously store multiple sample racks 110. The first transport path 811 is provided with a stopper 811a for supplying sample racks 110 one by one to the second transport path 812. The stopper 811a is a movable stopper that moves up and down, and is located at the boundary with the second transport path 812.

[0090] The stopper 811a is rotatable in the front-rear direction, and when rotated from rear to front, it protrudes upward, and when rotated in the opposite direction, it is retracted downward. The stopper 811a does not protrude from the upper surface when transporting a sample rack 110 on the first transport path 811 to the second transport path 812. When transport of the rack to the second transport path 812 is complete, the stopper 811a rotates forward and is positioned so as to be interposed between the sample rack 110 on the second transport path 812 and the sample rack 110 on the first transport path 811. When the stopper 811a enters between the sample racks 110, the two racks are separated. A movable stopper 813a similar to the stopper 811a is also provided on the third transport path 813 at the boundary with the fourth transport path 814.

[0091] 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 one another. The second transport path 812 is provided with a transport belt 812b that can transport the sample rack 110 in both the left-right and right-left directions. 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 of the fourth transport path 814. The fifth transport path 815 is provided with a transport belt 815b that can transport the QC sample rack 160 that is carried in from the third transport path 23 of the transport unit 20 to the right.

[0092] The conveyor unit 81 includes a plurality of rack output units for transferring the sample rack 110 between 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.

[0093] The conveyor unit 81 includes rack output units, which are a first output unit 816A, a second output unit 816B, a third output unit 816C, a fourth output unit 816D, and a fifth output unit 816E. The first output unit 816A includes an engagement unit 816f that contacts the front surface of the sample rack 110 and pushes 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.

[0094] The first sender 816A includes, as the drive 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. The motor 816i may be, for example, a stepping motor. In the first transport path 811, a sample rack 110 pushed by the engaging portion 816f hits the preceding rear sample rack 110 and stops. Therefore, the first sender 816A is provided with a torque sensor 816j that can detect this state.

[0095] The first sender 816A is configured to return the engaging portion 816f to the origin position shown in Fig. 8 when the torque sensor 816j is activated. The engaging portion 816f is pivotally supported rearward relative to the connecting member 816h so that, for example, when returning to the origin position, the engaging portion 816f will not push the sample rack 110 forward even if the engaging portion 816f hits the following sample rack 110. 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.

[0096] 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.

[0097] The conveyor unit 81 is provided with sensors 818a and 818b for detecting the sample rack 110 on the first transport path 811. It is also provided with 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. It is also provided with 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.

[0098] The conveyor unit 81 further includes a sensor 818d that detects containers 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 the detection information of the sensor 818d, and therefore, if the sensor 818d does not detect a container, 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.

[0099] The sensors 818a, 818c, 818e, 818f, 818i, and 818j are, for example, reflective optical sensors in which the light-emitting unit and the light-receiving unit are integrated. The sensors 818b, 818d, 818g, and 818h are, for example, photointerrupter-type optical sensors in which the light-emitting unit and the light-receiving unit are separated. The fourth transport path 814 is formed with an opening 814d that is large enough to allow the sample rack 110 to be transported without interference. The light-emitting unit of the sensor 818h is located below this opening 814d, and the light-receiving unit is located near the right end of the fourth transport path 814.

[0100] When a sample rack 110 is set on the first transport path 811, it is detected by sensor 818b and transported by the first sender 816A to the right end position of the second transport path 812. The sample rack 110 transported to the right end position of the second transport path 812 is detected by sensor 818c and 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, sensor 818d located in the middle of the second transport path 812 detects whether or not there are any containers stored in the rack.

[0101] 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 toward each other, and sequentially read the sample IDs of the sample containers 100 contained 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 from Figure 8 to simplify the illustration.

[0102] The first information reading unit 817A reads the sample ID for the sample containers 100 with storage position numbers 6 to 10 shown in Figure 4, and the second information reading unit 817B reads the sample ID for the sample containers 100 with 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.

[0103] 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.

[0104] 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 and 818g, and is transported to the fourth transport path 814 by the third sender 816C. The sample rack 110 transported to the fourth transport path 814 is detected by 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.

[0105] A QC sample rack 160 containing QC sample containers 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 recovered from the third transport path 23 of the transport unit 20 to the fifth transport path 815. The QC sample rack 160 transported into the fifth transport path 815 is detected by a 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 a sensor 818j at the right end position of the fifth transport path 815 and transported to the first transport path 811 by the fifth sender 816E.

[0106] [Insertion section 83] 8, the input section 83 includes a first input section 83A that transfers the QC sample container 150 from a first input port 831A to an extraction position P5, and a second input section 83B that transfers the cleaning agent container 180 from a second input port 831B to an extraction section 839. The extraction position P5 is a position where the QC sample container 150 accessible to the transfer section 85 is extracted, and the rear end of the first input section 83A becomes the extraction position P5. The extraction section 839 includes a transfer plate 839d, a sensor 839h, etc., and is provided at the rear end of the second input section 83B.

[0107] The first input section 83A has a transfer path 830A for the QC sample container 150 that extends along the front-rear direction. Similarly, the second input section 83B has a transfer path 830B for the detergent container 180 that also extends along the front-rear direction. In this embodiment, the transfer paths 830A and 830B are formed parallel to each other. Sensors 835f and 835g that detect the transfer holder 834 are provided near the first input port 831A and near the removal position P5, respectively. The sensors 835f and 835g may be proximity sensors such as magnetic sensors or eddy current sensors.

[0108] 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 functions not only as a passage for transferring the cleaning agent container 180, but also as a storage section for storing the plurality of cleaning agent containers 180. For this reason, a plurality of sensors 836d that detect 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.

[0109] 9 and 10 are perspective views of input unit 83. Fig. 9 shows a state in which transfer holder 834 is positioned at first input unit 83A, and Fig. 10 shows a state in which transfer holder 834 is positioned at removal position P5. As shown in Figs. 9 and 10, input unit 83 is a device in which first input unit 83A and second input 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.

[0110] 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 that can store one QC sample container 150 each. The transfer holder 834 is formed in a block shape overall, and has a plurality of storage sections 834a formed on its upper surface as holes into which the QC sample containers 150 can be inserted. The storage sections 834a are preferably formed with a depth such that, when a QC sample container 150 is inserted, the upper part of the tube 101 gripped by the arm 85b of the transfer section 85 protrudes from the upper surface of the transfer holder 834.

[0111] A through-hole 834b communicating with the storage section 834a is formed in the side of the transfer holder 834. The through-holes 834b are aligned in the left-right direction and formed on both side surfaces of the transfer holder 834. In this embodiment, there are three storage sections 834a aligned in a row 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 light-receiving section that make up the sensor 833e are installed on both side surfaces of the frame 833d so that light passes through the storage section 834a via the through-holes 834b. This allows the first insertion port 831A to detect the presence or absence of a QC sample container 150 in each storage section 834a.

[0112] Drive mechanism 835 includes an endless belt 835a extending along inclined portion 833c, a connecting member 835b connecting transfer holder 834 and belt 835a, a motor 835c including a rotating shaft around which belt 85c is suspended, a pulley 835d around which belt 85c is suspended, and a rail 835e that guides the movement of transfer holder 834. Transfer holder 834 is movably attached to frame 833 via this drive mechanism 835.

[0113] 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 transfer section 85 removes the QC sample container 150 from the storage section 834a and transfers it to the information reading section 87. When all the QC sample containers 150 have been removed from the transfer holder 834, the transfer holder 834 automatically moves to the first input port 831A, for example.

[0114] As described above, the first cover 832A covering the first insertion port 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 port 831A and is detected by the sensor 835f, the lock on the first cover 832A is released.

[0115] 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. A rail 838 is provided between the frame 836 and the opposing plate 837 to support the flange 181 of the cleaning agent container 180 in a state in which the cleaning agent container 180 is slidable. The cleaning agent container 180 slides along the transfer path 830B with the flange 181 supported and suspended by the rail 838, and is stored in the transfer path 830B.

[0116] The removal unit 839 includes a transfer plate 839d that moves left and right while holding the detergent container 180, and is configured to cause the detergent container 180 to protrude 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 is provided with a drive mechanism including a belt 839e, a motor 839f, and a pulley 839g.

[0117] The transfer plate 839d has a holding portion formed in the center of the plate that can accommodate the detergent container 180. When the transfer plate 839d moves leftward while holding the detergent container 180, the lower end of the detergent container 180 comes into contact with the upper surface of the inclined block 839c. Because the upper surface of the inclined block 839c is inclined so that it becomes higher toward the left, the detergent container 180 is pushed up along the upper surface of the inclined block 839c and becomes available for gripping by the transfer portion 85.

[0118] The removal unit 839 is provided with a sensor 839h that detects upward protrusion of the detergent container 180. The light-emitting unit and light-receiving unit that make up 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 upward protrusion of the detergent container 180, the transfer unit 85 transfers the detergent container 180 from the removal unit 839 to an empty rack 170 in the rack storage unit 88.

[0119] [Cooling section 84] 11 and 12 are perspective views of the cold insulation unit 84. FIG. 11 shows the cold insulation unit 84 with its cover 842 closed, and FIG. 12 shows the cold insulation unit 84 with its cover 842 open. FIG. 12 also shows the cold insulation unit 84 with part of the intake duct 846 removed. The cold insulation unit 84 is a storage cabinet for storing QC sample containers 150 and has the function of cooling the QC sample containers 150. The cold insulation unit 84 includes a block-shaped cold insulation unit main body 841 that forms a cold insulation chamber 841a for storing the QC sample containers 150 in a cooled state, a cover 842 that covers the cold insulation chamber 841a, and an opening / closing mechanism 843 for the cover 842. The cold insulation 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 insulation unit 84 includes a base 848 on which the cold insulation unit main body 841 is placed.

[0120] The temperature of the refrigerated compartment 841a and the opening and closing of the cover 842 of the refrigerated section 84 are controlled by the control section 82a. The temperature of the refrigerated compartment 841a is, for example, 2°C to 8°C and is always controlled to a substantially constant temperature. The cooling of the refrigerated section 84 continues even after the sample analysis system 1 is shut down. The cover 842 is automatically opened and closed when a QC sample container 150 is inserted or removed.

[0121] 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 within a cold storage chamber 841a covered with a cover 842. The storage sections 841b are holes that open upward and allow the QC sample containers 150 to be inserted, and in the example shown in Fig. 12, nine storage sections 841b are formed lined up in a row in the left-right direction. The storage sections 841b are formed deep enough that, when a QC sample container 150 is inserted, 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.

[0122] Although an evaporation compression type cooling device equipped with a compressor or the like may be used as the cooling means in cold insulation unit main body 841, in this embodiment, a Peltier element is built in from the viewpoint of miniaturization of the device, etc. Cold insulation unit main body 841 is provided with fan 845 as heat dissipation means for the Peltier element. Also, cold insulation unit main body 841 is provided with a metal cooling block cooled by the Peltier element, heat dissipation fins, a temperature sensor, etc.

[0123] Cover 842 closes the opening of cold storage compartment 841a to keep the inside of cold storage compartment 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 top 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.

[0124] Cover 842 is configured to be opened by rotating rightward by opening / closing mechanism 843 provided at the right end of cold storage unit main body 841 .

[0125] Opening / closing mechanism 843 includes rotating shaft 843a, bearing member 843b fixed to the right end of cooling unit main body 841 and rotatably supporting rotating shaft 843a, connecting member 843c connecting the right end of cover 842 to rotating shaft 843a, and a drive mechanism for rotating rotating shaft 843a. Opening / closing mechanism 843 includes, as a drive mechanism for rotating shaft 843a, endless belt 843d suspended at the rear end of rotating shaft 843a, and motor 843e having a rotating shaft around which belt 843d is suspended and driving belt 843d. Rotating shaft 843a extends in the front-rear direction. Motor 843e is fixed to base 848.

[0126] 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 or 843g is a proximity sensor such as a magnetic sensor or an eddy current sensor. The sensors 843f or 843g are configured to detect the opening or 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.

[0127] Fan 845 is a heat dissipation means for releasing heat from the Peltier element, and is installed at the rear of cooling unit main body 841. Fan 845 is connected to intake duct 846 and exhaust duct 847, with intake duct 846 extending to the right above fan 845 and exhaust duct 847 extending downward below fan 845. When fan 845 operates, air is drawn in through the inlet port of intake duct 846, passes through the heat-generating unit, and is exhausted from the outlet port of exhaust duct 847.

[0128] [Transfer section 85] As shown in Figure 13, the transfer unit 85 includes a base portion 85a that is a plate-like base that is long in the vertical direction, and a pair of arms 85b that grip the QC sample container 150. The base portion 85a is provided so that the plate surface is aligned in the vertical and front-to-rear directions. The pair of arms 85b are spaced apart in the front-to-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.

[0129] 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 places the used QC sample container 150 in the first collection section 89A for disposal.

[0130] 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 the removal section 839 (see FIG. 8, etc.) of the second input section 83B and transferred directly to the front rack of the rack housing section 88. The transfer section 85 discards the used cleaning agent container 180, which has been collected in the rack housing section 88 after cleaning of the measurement unit, by putting it into the second collection section 89B.

[0131] The base portion 85a is provided with a drive mechanism for the arms 85b, which includes 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. 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.

[0132] The pair of arms 85b are movable in three directions: front-back, left-right, and up-down. The transfer unit 85 includes a first drive mechanism that moves a base unit 85a, to which the arms 85b are attached, in the front-back 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 relative to the frame 82f in a state in which it can move front-back and left-right. The base unit 85a is also provided with a third drive mechanism 853 (see FIG. 14 described below) that moves the drive mechanism of the arms 85b, which includes the pair of arms 85b and the belt 85c, in the up-down direction.

[0133] The pair of arms 85b grip, for example, the upper part of the tube 101 of the QC sample container 150. Since the QC sample container 150 is provided with a cap 102 having an outer diameter larger than that of the tube 101, when the arms 85b grip the upper part of the tube 101, the arms 85b get caught on the cap 102, more reliably preventing the QC sample container 150 from falling off. In addition, 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.

[0134] [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 unit 86b is a hole that opens upward and into which a QC sample container 150 can be inserted, and multiple storage units 86b are formed in the heating unit main body 86a. Each storage unit 86b stores one QC sample container 150 in an upright position. In the example shown in Fig. 13, six storage units 86b are formed in a row in the left-right direction.

[0135] The storage section 86b is preferably formed to a depth such that, when the QC sample container 150 is inserted, the top of the tube 101 gripped by the arm 85b of the transfer section 85 protrudes from the top surface of the heating section main body 86a. The heating section 86 does not have a cover, and there are no large protrusions on the top surface of the heating section main body 86a. The number and arrangement of the storage sections 86b are not particularly limited, and for example, the storage sections 86b may be arranged in a staggered pattern.

[0136] As described above, the heating unit 86 heats the QC sample container 150 that has been refrigerated and stored in the refrigeration unit 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 preferred refrigerated storage temperature is 2°C to 8°C, the heating unit 86 needs to raise the temperature of the quality control material by, for example, approximately 12°C to 24°C. The heating unit 86 heats the QC sample container 150 inserted into the storage unit 86b so that the quality control material in the QC sample container 150 reaches the measurement temperature.

[0137] The heating unit 86 is equipped with a heater that generates heat using electricity. The heater is preferably an aluminum block heater. Because 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 when a liquid medium is used. In addition, the aluminum block has high thermal conductivity, so 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.

[0138] The heater temperature is set to a temperature higher than the measurement temperature within a range that does not degrade the quality control material, and is preferably 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 using the blowing means. The heating unit 86 may be equipped with a heater and a fan.

[0139] [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 toward 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 placed 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.

[0140] 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 refrigerated storage. The information reading section 87 transmits the read QC sample ID information to the control section 82a, and the control section 82a uses that information to perform 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 selection of the QC sample container 150 to be used for quality control measurements.

[0141] [Rack storage section 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 empty racks 170 in the front-to-rear direction and that can store multiple empty racks 170. The transport path 88a extends long in the front-to-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.

[0142] Three stoppers 88b, 88c, and 88d are provided in the transport path 88a in order from the front. Stopper 88c is disposed in the center of the transport path 88a in the front-to-rear direction, and regulates the forward movement of empty racks 170 stored in the transport path 88a. Stopper 88d is disposed closer to the rear end of the transport path 88a than stopper 88c, and regulates the rearward movement of the empty racks 170. The area sandwiched between these stoppers 88c and 88d is an area in which empty racks 170 can be stored, and in this embodiment, the distance between stoppers 88c and 88d in the front-to-rear direction corresponds to the length of seven empty racks 170 in the front-to-rear direction.

[0143] As described above, the rack storage section 88 also serves as a location for storing the QC sample containers 150 and the detergent containers 180 in the empty racks 170. The QC sample containers 150 and the detergent containers 180 are stored in the front rack, which is the frontmost of the multiple empty racks 170, and therefore a space is secured above the front rack and its vicinity on the transport path 88a to serve as a path for the transfer section 85. The position of the front rack is determined by a stopper 88c that stops the empty rack 170 from moving forward, and in this embodiment, the front rack is aligned in the left-right direction with the first collection section 89A, the second collection section 89B, and the heating section 86.

[0144] The rack storage section 88 is equipped with a transport arm 881 for transporting empty racks 170, QC sample racks 160 containing QC sample containers 150, and racks containing detergent containers 180 (hereinafter referred to as "detergent racks") in the forward and backward directions. The transport arm 881 is capable of pushing the empty racks 170 etc. forward and also of pulling the empty racks 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. Furthermore, the tips of the pair of transport arms 881 are formed with claws 881a that protrude toward the inside of the transport path 88a.

[0145] 16 and 17, the configuration of the rack storage unit 88 will be described in further detail. The transport path 88a of the rack storage unit 88 is connected to the second transport path 812 of the conveyor unit 81, and is arranged to face the first transport path 811 across the second transport path 812. In other words, the first transport path 811 and the transport path 88a are arranged side by side in the front-to-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.

[0146] 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 and the like being pushed from the first transport path 811 to the second transport path 812 from entering the transport path 88a. When an empty rack 170 and the like 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. Note that since the empty rack 170 and the like are transported to the rear of the stopper 88c, the stopper 88c is lowered in conjunction with the stopper 88b. The stoppers 88b and 88c may be mechanically connected, for example, by a link mechanism or the like.

[0147] The transport arm 881 is movable in the front-rear direction to the front of the second transport path 812, and can push the QC sample rack 160 etc. up to the second transport path 812 and pull the QC sample rack 160 etc. 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 into the rack storage section 88 via the first transport path 811 and the second transport path 812.

[0148] The transport arm 881 is moved 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 toward and away 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 is movable in the left-right direction between an engagement position where the claws 881a of the transport arm 881 are positioned on the transport path 88a and engage with the racks on the transport path 88a, and a retracted position where the claws 881a are retracted from the transport path 88a.

[0149] 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 the QC sample rack 160 (front-end rack) onto the second transport path 812, the transport arm 881, which is in 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, and the claw 881a is inserted 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 881a of the transport arm 881, and the QC sample rack 160 is pushed onto the second transport path 812.

[0150] Four sensors 882a, 882b, 882c, and 882d are provided in the rack storage section 88 in order from the front along the transport path 88a. Sensor 882a detects racks between stoppers 88b and 88c at the front end of the transport path 88a, and sensor 882b detects the front-end rack. When empty racks 170 are stored in the rack storage section 88, the transport arm 881 moves the empty racks 170 forward so that there is always a front-end rack that can store a QC sample container 150 and a detergent container 180.

[0151] The sensor 882c detects the QC sample containers 150 and detergent containers 180 contained in the front rack. The sensor 882d detects the presence or absence of a rack at the rear end of the transport path 88a, specifically, the empty rack 170 immediately before the stopper 88d (see FIG. 15). If the sensor 882d does not detect an empty rack 170, this means that a rack containing a QC sample container 150 or detergent container 180 is being transported to the measurement unit, or otherwise, there is space in the rack storage section 88 that can accommodate the empty rack 170.

[0152] 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 separate light-emitting and light-receiving units, and the sensors 882b and 882d may be reflective optical sensors with an integrated light-emitting and light-receiving unit. As will be described in more 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.

[0153] [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.

[0154] 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 as a touch panel, and all icons displayed on the screen 1000 are displayed so that they can be selected 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.

[0155] 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. 18.

[0156] 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 has, as content to be displayed in the main area, a QC status window 2001, a detergent container inventory window 2006, an empty rack inventory window 2007, a waste box window 2008, and a temperature display window 2009.

[0157] The QC status window 2001 includes a QC sample list 2001A that displays a list of information about 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 the control.

[0158] The QC sample list 2001A displays a list of information about 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 cold storage section 84. Starting from the leftmost column, the QC sample list 2001A includes 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.

[0159] In the example of Fig. 19, for example, information about the QC sample container 150 stored in the storage section 841b at position number 1 is displayed in the row corresponding to position number "1." In the example of Fig. 9, the QC sample container 150 stored at position number "1" has registered information such as a concentration level of "Level 1," a lot number of "A001XXXX," a remaining amount of 20 tests, and an expiration date of "March 30, 2021."

[0160] The information in the QC sample list 2001A is registered by the information reading unit 87 reading information about the QC sample container 150 set via the above-mentioned input unit 83. Attribute information including the concentration level of the QC sample, the lot number, the number of remaining tests, and the expiration date is stored on the machine-readable label 103 of the QC sample container 150. 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 placed in one of the available storage sections 841b in the cooling section 84 by the transfer 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 below) in association with the position number of the storage section 841b in which the QC sample container 150 is placed.

[0161] The information in the QC sample list 2001A displays a list of information about the QC sample containers 150 under the control of the supply unit 80. Even if a QC sample container 150 has been removed from the refrigerated section 84 (for example, while being transported for quality control measurement), the information about the QC sample container 150 is displayed in the row of the position number corresponding to that QC sample container 150. Information about a QC sample container 150 that has been removed from the refrigerated section 84 is displayed with a different background color to distinguish it from QC sample containers 150 stored in the refrigerated section 84, as shown by hatching in FIG. 19 .

[0162] As shown in Figure 19, the QC sample list 2001A highlights the corresponding cell in the fourth column, which displays the remaining amount, when the number of remaining tests falls below a predetermined value. For example, in the example of Figure 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 in reverse. The threshold for highlighting can be set as appropriate; for example, highlighting may be displayed when the number of remaining tests is less than 5. This allows the user to easily recognize the presence of QC sample containers 150 where the remaining amount is low or has reached zero.

[0163] 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 a QC sample container 150 stored in the cold storage 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 in reverse. The conditions for highlighting can be set as appropriate, and for example, the highlighting may be performed when the number of days remaining until the expiration date falls below a threshold. For example, the highlighting may be performed when the number of days remaining until the expiration date falls below 10 days. This allows the user to easily recognize the existence of QC sample containers 150 whose expiration date is approaching or has passed.

[0164] In the example of FIG. 19, only the cells in the fourth or fifth column are highlighted, but the entire row may also be highlighted.

[0165] A remaining quantity display section 2001B is provided above the QC sample list 2001A. The remaining quantity 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 in the remaining quantity 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 quantity display section 2001B eliminates the need for the user to calculate the remaining number of tests for each concentration level, making management easier.

[0166] 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 multiple sensors 836d installed along the transfer path 830B. Of these, the sensor 836d located at the front of the device (the lower side of the paper in FIG. 8) is positioned so that it can detect the 15th detergent container from the beginning. The control section 82a displays the remaining number of detergent containers 180 based on the output from this front sensor 836d. For example, when the sensor 836d detects a detergent container 180, it displays "15+," as shown in FIG. 19, indicating that the remaining number is 15 or more. If the sensor 836d detects a 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 stock.

[0167] In addition, in the modified supply unit 80K described below, the control unit 82a recognizes the number of all detergent containers set in the unit, so the number of displayed inventory bottles changes depending on the number of detergent containers used by the supply unit 80.

[0168] The empty rack inventory window 2007 displays the number of empty racks 170 housed in the rack housing 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.

[0169] The waste box window 2008 displays the number of containers that can be disposed of in each of the first collection section 89A and the second collection section 89B, which are waste boxes.

[0170] 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.

[0171] 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 refrigerated section 84. The removal icon 2004 will be explained later using 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.

[0172] 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 Supply Unit (BT-50) Only."

[0173] When "Specified 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 follows the instructions on the screen to select the device to be shut down. The screen 2101 also displays the next scheduled automatic startup schedule 2101B and a button 2101C for calling up details of the next automatic startup schedule. The user confirms the next automatic startup schedule displayed on the screen and then presses the OK button at the bottom of the screen to shut down the selected device. Shutting down the measuring unit and processing unit means, for example, transporting a detergent rack containing detergent containers to the device, performing cleaning in the device, and turning off the power to the device after cleaning is complete, as will be described below with reference to FIG. 50. In the following description, the four measurement units that make up the sample analysis system 1 will be referred to as "XN-1," "XN-2," "XN-3," and "XN-4," respectively, and the processing unit 40 will be referred to as "SP-1."

[0174] 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 details of the next schedule. When the OK button at the bottom of the screen is pressed, the entire system is shut down.

[0175] When "End supply unit alone" is selected, a supply unit shutdown screen 2103 is displayed, which reconfirms to the user that only the supply unit 80 will be shut down. When the OK button at the bottom of screen 2103 is pressed, only the supply unit 80 will be shut down independently. Shutting down the supply unit 80 means turning off the power to the supply unit 80, and does not transport the cleaning agent rack.

[0176] When the OK button on any of screens 2101-2103 is pressed and there is a shortage of consumables for the next automatic QC scheduled for the next automatic startup, screen 2104 is displayed. Screen 2104 includes the message, "There are insufficient consumables required to perform the next scheduled operation registered in the schedule." This screen 2104 is displayed when, upon receiving a shutdown instruction via screens 2101-2103, there are insufficient QC sample containers 150 stored in the refrigerated unit 84 and empty racks 170 housed in the rack housing unit 88 to perform the next automatic QC scheduled for the next automatic startup. As described with reference to FIG. 19 , the control unit 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 refrigerated unit 84. The control unit 82a also stores the number of empty racks 170 housed in the rack housing unit 88. The control unit 82a determines whether there is a sufficient inventory of QC sample containers 150 and whether there is a sufficient inventory of empty racks 110 based on the QC conditions for the automatic QC to be executed at the next automatic startup, and if there is a shortage, displays screen 2104 on the monitor 91. If the user wants to cancel the shutdown and replenish the consumables, he or she presses Cancel. If the user wants to continue the shutdown as is, he or she presses the OK button, and the shutdown continues as instructed. Displaying screen 2104 before shutdown prevents, for example, the supply unit 80 from being shut down without replenishing the consumables required for the next day's automatic QC.

[0177] On the device selection screen 2101, the desired device can be shut down simply by specifying the device on the screen and pressing the OK button. This eliminates the need for the user to go through the trouble of shutting down each device one by one, which is highly convenient. It is also convenient in that it eliminates the need for the user to manually operate the device, such as using a detergent rack with a rack barcode dedicated to a specific device in order to supply detergent containers 180 to that specific device.

[0178] Furthermore, when shutting down the entire system, the user simply presses the OK button on screen 2102. This eliminates the need for the user to go through the trouble of shutting down all of the devices. Furthermore, even if the sample analysis system 1 includes multiple devices, there is no need to manually prepare the cleaning agent containers 180 required to clean all of the devices, which is convenient.

[0179] FIG. 21 shows 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 on the device status screen 2000 and a location selection button 2201. While checking the QC sample list, the user can select the location selection button 2201 corresponding to the location number of the QC sample container 150 they wish to remove and then select the OK button at the bottom of the screen. The location selection button 2201 allows up to three containers to be selected simultaneously, corresponding to the maximum number of containers that the transfer holder 834 can accommodate (three). In the example of FIG. 21, the QC sample containers 150 with location numbers 2, 6, and 7 are selected. As described with reference to FIG. 19, the QC sample containers 150 with location numbers 1, 4, and 5 have been removed from the refrigerated section 84 and cannot be removed. Therefore, the location selection buttons 2201 corresponding to these location numbers are not selectable, and the check boxes are grayed out.

[0180] When the QC sample container 150 to be removed is selected using the position selection button 2201 and the OK button is pressed, the selected QC sample container 150 is removed from the refrigerated section 84 and set in the transfer holder 834 at the removal position P5 (position shown in FIG. 10) of the insertion section 83. The transfer holder 834 with the QC sample container 150 set therein then 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 notify 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.

[0181] 22 is an example of an input screen 2300 that is 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 transfer holder 834 is positioned at the first input port 831A, and the first cover 832A is unlocked. 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, when the first cover 832A is unlocked. When the user sets the QC sample container 150 in the transfer holder 834 and presses the OK button at the bottom of the screen, the QC sample container 150 is transferred inside the supply unit 80 and stored in the cooling section 84. This process will be described later.

[0182] 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 corresponding to each day of the week, and a schedule list 2402 that displays a list of schedules. The day-of-the-week tabs 2401 display seven selectable tabs that display the names of the seven days of the week: Monday, Tuesday, Wednesday, Thursday, Friday, Saturday, and Sunday. The user can specify the day of the week for which the schedule is to be set by selecting any tab. Note that while FIG. 23 shows an example in which a schedule is registered for each day of the week, it is also possible to register a schedule by specifying a date, for example. For example, a weekly or monthly calendar may be displayed, and a schedule may be registered by specifying a specific date on the calendar.

[0183] FIG. 23 shows the state in which the Monday tab is selected. Schedule list 2402 displays schedules scheduled to be executed on a specified day of the week in chronological order. In the example of FIG. 23, wake-up (automatic startup) is scheduled for 7:30 AM on Monday, quality control measurement (automatic QC) for 1:00 PM, and automatic cleaning for 11:00 PM. A button 2403 for switching ON / OFF is provided corresponding to each schedule in schedule list 2402. The user operates button 2403 to set "ON" if the registered schedule is to be executed, or to set "OFF" if the schedule is not to be executed. A schedule set to ON is automatically executed at the same time every week unless it is set to OFF.

[0184] A selectable registration icon 2404 for registering a schedule is 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, the user presses the registration icon 2404.

[0185] 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," "Quality Control," and "Cleaning." In this embodiment, information about the registered schedule is saved in the memory of the control unit 82a.

[0186] When the "Start" menu is selected on the schedule registration screen 2500, a registration screen 2501 is displayed. The screen 2501 is a screen for registering an automatic wake-up schedule. The screen 2501 includes multiple 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 is displayed with seven options: Monday, Tuesday, Wednesday, Thursday, Friday, Saturday, and Sunday. The user can select any day of the week. The time pull-down menu includes a pull-down button for specifying the time in one-hour increments and a pull-down button for specifying the time in one-minute increments. The user can specify the time by operating the pull-down menu. Although the example in FIG. 24 illustrates only a pull-down menu, 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.

[0187] 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" if automatic QC is to be performed, or to turn "OFF" if automatic QC is not to be performed. Automatic QC is an automatic quality control measurement using the QC sample container 150 stored in the refrigeration unit 84.

[0188] When an automatic wake-up schedule with automatic QC set to ON is registered, one or more measurement units included in the sample analysis system 1 are automatically started according to the schedule, and further, a QC sample container 150 is automatically supplied to the started one or more measurement units to perform quality control measurements. When an automatic wake-up schedule with automatic QC set to OFF is registered, the power of each unit of the sample analysis system 1 is automatically turned on, but quality control measurements are not performed.

[0189] 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 measurements (QC conditions) from the user on the registration screen 2502. As will be described in more detail below, the sample analysis system 1 determines one or more QC sample containers 150 to be used for quality control measurements from among the multiple QC sample containers 150 stored in the refrigeration unit 84, based on the QC conditions and the information about the QC sample containers 150, and transports the determined QC sample containers 150 to the measurement unit to measure the QC samples.

[0190] Registration screen 2502 is a screen for creating an automated QC schedule. Like screen 2501 described above, screen 2502 includes multiple pull-down buttons for specifying the day of the week and time. Below the pull-down buttons are three concentration level buttons, "Level 1," "Level 2," and "Level 3," for selecting the type of QC sample to be used in one automated QC. Below the concentration level buttons, a unit selection image is displayed for selecting the measurement unit for which quality control measurements will be performed in the automated QC. The unit selection image includes an image illustrating multiple units arranged according to the layout of sample analysis system 1.

[0191] The user sets the day of the week and time to perform 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 Figure 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 will be performed in automatic QC from the unit selection image.

[0192] 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 settings shown in Fig. 24, the automatic QC conditions are set to perform quality control measurements at 8:30 AM on Monday for the three measuring units XN-1, XN-3, and XN-4, using two QC sample containers 150, one at level 1 and one at level 2. When the "OK" button at the bottom of screen 2502 is selected, a confirmation screen 2510 (described below) is displayed, and when a confirmation operation is performed, the entered schedule is registered in the list. In this embodiment, the registered automatic QC conditions are stored in the memory of the control unit 82a.

[0193] When the "Cleaning" menu is selected on the schedule registration screen 2500, a registration screen 2503 is displayed. Screen 2503 is a screen for registering a schedule for automatic cleaning. Automatic cleaning is the automatic cleaning of the measuring unit and processing unit using the cleaning agent container 180 stored in the second loading section 83B. Registration screen 2503 differs from 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 screen 2502.

[0194] 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 automatically cleaned. 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.

[0195] Fig. 25 is an example of a confirmation screen 2510 that is displayed when an automatic QC schedule is entered on registration screen 2502 and the "OK" button is pressed. As shown in Fig. 25, confirmation screen 2510 displays the specified day of the week, time, and automatic execution content. When an automatic QC schedule specifying multiple concentration levels is created on registration screen 2502, the combination of multiple concentration levels is displayed as the content of the automatic execution schedule, as shown in Fig. 25.

[0196] Fig. 26 illustrates operations for an automatic execution schedule displayed in the schedule list from the schedule screen 2400 of Fig. 23. When the user selects an automatic execution schedule that they wish to operate on screen 2400, an operation menu 2410 is displayed. The operation menu 2410 includes three options: "Execute," "Edit," and "Delete."

[0197] "Execute" is used when the selected schedule is executed ahead of the scheduled time. When "Execute" is pressed in the operation menu 2410, a confirmation screen 2420 containing the details of the scheduled automatic execution is displayed along with a confirmation message asking "Do you want to execute the contents of the selected schedule 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 will not be executed at the originally scheduled time.

[0198] "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 Figure 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.

[0199] "Delete" is used to delete a schedule that has already been registered. When deleted, the target schedule is removed from the schedule list.

[0200] 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, from top to bottom, of the scheduled automatic execution schedules registered on the schedule registration screen 2500 that correspond to the day of the operation.

[0201] The inventory display area 2602 displays a graph showing the inventory status of consumables stored in the supply unit 80. In the example of FIG. 27, a bar graph shows the remaining amounts of multiple types of consumables on a horizontal axis with future dates plotted to the right, starting from the current time. The bar graph indicates how long the consumables will be available if the registered schedule is executed as scheduled using the consumables inventory stored in the supply unit 80. In the example of FIG. 27, a bar graph showing the inventory of QC sample containers 150 with concentration levels 1, 2, and 3 and cleaning agent containers (CCA) 180 is displayed. A message regarding the consumables inventory is displayed below the graph. For example, if the number of empty racks 170 stored in the rack storage section 88 falls below a predetermined number, a message such as "Empty racks: Refillable" is displayed, as shown in FIG. 27. The message also includes an alert urging the user to replenish consumables if there is a shortage of consumables required to execute the scheduled automatic execution schedule. For example, in FIG. 27, if the remaining number of tests for 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 the next scheduled automatic start schedule. By confirming the alert, the user can replenish consumables in advance. Note that in FIG. 27, the dates on which the schedule can be executed within the range of consumable inventory are displayed using a bar graph, but the display format does not have to be a graph; only the date may be displayed. Furthermore, the display is not limited to dates; the remaining number of days or remaining number of times the schedule can be executed based on inventory may be displayed numerically or graphically.

[0202] 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, including 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, of the processes related to quality control measurements, those 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 executed mainly 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.

[0203] The control unit 82a, like the control unit 31 of the control unit 30 and the control unit 71 of the transport controller 70, is configured as a computer and includes a processor, a storage unit, an input / output port, etc. A control program for executing processes such as refrigerated storage, transportation, and heating of the QC sample container 150 is installed in the control unit 82a. The control unit 82a also stores a database 820 that stores information about quality control samples. As described above, the database 820 contains information about each QC sample container 150 associated with the position number of the storage unit 841b of the cooling unit 84.

[0204] A database 310 related 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 that are measurement results of QC samples, and include measurement results for each measurement date and time, concentration level of the QC sample, and each lot. An example of a QC file stored in the database 310 is shown in FIG. 49, which will be described later. The user can use this database 310 to check, for example, the state of the measurement unit and the differences between QC sample lots, which will be described later.

[0205] FIG. 29 shows an example of a database 820 stored in the control unit 82a. The database 820 includes attribute information and remaining quantity information for each QC sample container 150 stored in the refrigerated 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 database includes a first column indicating the position number of the storage unit 841b in the refrigerated unit 84, a second column indicating the concentration level of the QC sample container 150, a third column indicating the lot number, a fourth column indicating the number of remaining tests, which is remaining quantity information, and a fifth column indicating 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 measurements are determined.

[0206] An example of the processing related 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 related to automatic QC and automatic cleaning is mainly executed by the functions of the control unit 31 of the control unit 30 and the control unit 82a of the supply unit 80. Below, reference will be made as appropriate to Figures 42 to 45 which show the operation of the supply unit 80.

[0207] Figure 30 is a flowchart 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 specified time (step S1). If the current time is a predetermined time before the specified time, the control unit 82a executes automatic wake-up (step S2). The process of S2 will be described later with reference to Figure 31.

[0208] When the power of each unit constituting the system is turned on by automatic wake-up, the control unit 82a determines whether the scheduled automatic QC time has arrived (step S10). This determination is made based on the registration information of the automatic QC schedule stored in the control unit 82a. When the control unit 82a determines 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.

[0209] If the result of step S10 is NO, the control unit 82a determines whether the scheduled time for automatic cleaning has arrived (step S20). This determination is made based on the registration information of the automatic cleaning schedule stored in the control unit 82a. If the control unit 82a determines 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.

[0210] If the result of step S20 is NO, the control unit 82a determines whether or not the user has instructed the addition of a QC sample container 150 (step S30). For example, the control unit 82a determines 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 processing to store the QC sample container 150 in the cooling unit 84 (step S300). The processing of S300 will be described later with reference to FIG. 35.

[0211] If the result of step S30 is NO, the control unit 82a determines whether or not the user has instructed to remove the QC sample container 150 (step S40). For example, the control unit 82a determines 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.

[0212] If the result of step S40 is NO, the control unit 82a determines whether a rack has been set on the conveyor unit 81 of the supply unit 80 (step S50). If the control unit 82a determines that a rack has been set (YES in step S50), it performs rack storage or rack transport processing depending on the type of rack (step S500). The processing of S500 will be described later with reference to FIG.

[0213] If the result of step S50 is NO, the control unit 82a determines whether the rack sent out from the supply unit 80 has returned to the conveyor unit 81 (step S60). If the control unit 82a determines that the rack has returned (YES in step S60), 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.

[0214] 31 to 36, 40 and 41 are flowcharts showing the operation of the supply unit 80.

[0215] Figure 31 is a flowchart showing the automatic wake-up process. In step S2A, the control unit 82a turns on the power to 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 sends a startup command to each unit of the sample analysis system 1 when the current time is a predetermined time before the specified time. This turns on the power to all units that make up the sample analysis system 1. Note that the screen 2501 in Figure 24 may be configured to allow the user to specify the units that will perform automatic wake-up, and to send startup commands only to the specified units based on the schedule registration information.

[0216] The predetermined time is preferably longer than the time required for the heating unit 86 to heat the QC sample container 150 stored in the refrigerator unit 84 to 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. More preferably, the predetermined time includes not only the heating time but also the time required for the heated QC sample to be measured by the measurement unit and for the measurement results to be obtained. In one example, the predetermined time is 30 minutes. That is, if the wake-up time is set to 8:30, the control unit 82a sends a startup command at 8:00. This ensures that the QC sample has been heated and measured by the time specified by the user as the wake-up time, allowing the user to immediately start testing using the measurement unit at the specified time. The predetermined time may be fixed or variable depending on whether automatic QC is enabled or disabled and the QC conditions.

[0217] In step S2C, the control unit 82a determines whether automatic QC is set to ON. If automatic QC is set to ON, as shown on screen 2501 in Figure 24, the control unit 82a performs automatic wake-up followed by automatic QC in step S100. That is, if an automatic wake-up schedule with automatic QC 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. If automatic QC is set to OFF, only automatic wake-up is performed, and quality control measurement is not performed.

[0218] 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 performed following automatic wake-up, but also to automatic QC performed at times other than wake-up. In step S101, the control unit 82a determines the combination of QC sample containers 150 to be used for quality control measurement based on the conditions for quality control measurement (QC conditions) and information about the QC samples being stored. Although one QC sample container 150 may be used for quality control measurement, typically two or more QC sample containers 150 with different QC sample concentration levels are used.

[0219] The QC conditions include the specification of one or more measurement units to perform quality control measurements. When one or more measurement units to perform quality control measurements are specified, the control unit 82a determines one or more QC sample containers 150 to use depending on the number of specified measurement units. Furthermore, the QC sample information includes information on the type of QC sample, and the QC conditions include the specification of the type of QC sample to be used. The control unit 82a determines one or more QC sample containers 150 to use based on the specified QC sample type and the information on the QC sample type.

[0220] The QC conditions may include the specification of multiple concentration levels as the type of QC sample, the specification 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 specified multiple concentration levels. Also, it determines one or more QC sample containers 150 based on the specified lot and lot information of the QC sample. The QC sample information may include information on the remaining amount of QC sample in each QC sample container 150, and one or more QC sample containers 150 may be determined based on the specified number of measurement units and the remaining amount information.

[0221] As will be described in more detail below, if the remaining quantity of the first QC sample container 150 used for quality control measurement is less than the number of tests to be performed based on the specified number of 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 quantity 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.

[0222] As described above, the information on the QC samples includes attribute information and remaining amount information for each QC sample. Examples of 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 memory of the control unit 82a as a database 820. The QC conditions are also stored in the memory.

[0223] 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 transferring unit 85 to remove the QC sample container 150 determined in S101 from the cooling unit 84. The control unit 82a stores information about 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 transferring 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.

[0224] 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 measurements, each QC sample container 150 is stored in an empty rack 170 based on the automatic QC conditions stored in the memory unit.

[0225] In step S104, the control unit 82a controls the transport of the QC sample rack 160 containing the QC sample containers 150 from the supply unit 80. The control unit 82a controls the rack container 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 to transport the QC sample rack 160 to the notified measurement unit.

[0226] Figure 42 is a diagram showing the operation of the supply unit 80 in steps S102 to S104 of Figure 32. As shown in Figure 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 Figure 42(b).

[0227] When the number of QC sample containers 150 required for quality control measurements are accommodated in the accommodation section 111 of the empty rack 170 (front rack), as shown in Figure 42 (c), the rack accommodation section 88 sends out the QC sample rack 160, which is the front 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.

[0228] FIG. 33 is a flowchart showing a specific example of the process (step S101 in FIG. 32) for determining the combination of QC sample containers 150 to be used in quality control measurements. 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 determines whether or not measurement of a QC sample at concentration level N is necessary. If variable N is 1, a determination is made in step S1001 based on the concentration level designation of the QC conditions stored in the storage unit. For example, if the QC conditions include measurement of a QC sample at concentration level 1, as shown in screen 2502 in FIG. 24, a determination of YES is made in step S1001. If measurement of a QC sample at concentration level 1 is not designated, steps S1002 and S1003 are skipped and the process proceeds to step S1004.

[0229] In step S1002, the control unit 82a identifies one QC sample container 150 from the QC sample containers 150 stored in the refrigeration 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 currently in operation at concentration level 1. If there are multiple QC sample containers 150 with the same lot number, the one with the fewest remaining tests is identified.

[0230] In step S1003, the control unit 82a determines whether the number of remaining tests for the identified QC sample container 150 is equal to or greater than the number of tests in the quality control measurement. This determination 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 that is about to be performed, and determines YES if the number of remaining tests is equal to or greater than the number of tests planned to be performed.

[0231] In step 1004, the control unit 82a determines whether QC sample containers 150 for all concentration levels required for quality control measurements have been identified. This determination is made based on the concentration level designation of the QC conditions stored in the storage unit. For example, if the QC conditions specify measurements for concentration levels 1 and 2, steps S1001 to S1003 are executed for concentration level 2.

[0232] If the control unit 82a determines NO in step S1003, i.e., if the number of remaining tests for the identified QC sample container 150 is less than the number of tests to be performed, it determines in step 1005 whether another usable QC sample container 150 with the same concentration level is stored in the cold storage unit 84. This determination 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 for that other QC sample container 150 and the number of remaining tests for the previously identified QC sample container 150 (step S1006). Then, it returns to step S1003 and determines whether the summed number of remaining tests is equal to or greater than the number of tests to be performed.

[0233] The procedures of steps S1003, S1005, and S1006 are repeated until a YES determination is made in step S1003. If no other usable QC sample containers 150 of the same concentration level are stored in the refrigeration unit 84 (NO in step S1005), the control unit 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. A notification of the automatic QC error is displayed, for example, on the monitor 91. In this case, the user needs to set a QC sample container 150 of concentration level 1 in the supply unit 80.

[0234] 34 is a flowchart showing the automatic cleaning process (step S200 in FIG. 30) in the supply unit 80. 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.

[0235] The control unit 82a controls the transfer of the detergent container 180 to an empty rack 170 in the rack storage unit 88 in step S202, and the transportation of the detergent rack storing the detergent container 180 from the supply unit 80 in step S203.

[0236] Figure 43 is a diagram showing the operation of the supply unit 80 in steps S201 to S203 of Figure 34. The cleaning agent container 180 is transferred by the second input unit 83B from the second input port 831B (see Figure 9, etc.) to the removal unit 839, which is accessible to the transfer unit 85. However, as shown in Figure 43(a), when the transfer plate 839d is positioned on the right end side of the removal unit 839, the transfer unit 85 cannot grasp the cleaning agent container 180. For this reason, as shown in Figure 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.

[0237] As a result, the lower end of the detergent container 180 comes into contact with the upper surface of an inclined block 839c (see FIG. 9, etc.) arranged below the transfer plate 839d, pushing it up and making it possible to grasp it by the transfer unit 85. At this time, the pushed-up detergent container 180 is detected by the sensor 839h. When the sensor 839h detects the detergent container 180, the transfer unit 85 removes the detergent container 180 from the removal unit 839 and transfers it to the empty rack 170, as shown in FIG. 43(c). Similar to the QC sample container 150, the number of detergent containers 180 required for cleaning are transferred from the removal unit 839 and stored in the front rack of the rack storage unit 88. Similar to the QC sample rack 160, the detergent rack storing the detergent containers 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.

[0238] FIG. 35 is a flowchart 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.

[0239] 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 the transfer holder 834 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 about the QC sample container 150 under the control of the control unit 82a.

[0240] 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. Under the control of the control unit 82a, the transfer unit 85 stores the QC sample container 150 in the storage unit 841b of the cold storage room 841a. In step S307, the control unit 82a registers information about the QC sample container 150 acquired by the information reading unit 87 in the database 820 in association with the position number of the storage unit 841b that stores the QC sample container 150. The storage position of the QC sample container 150 in the cold storage unit 84 may have been determined when the information reading unit 87 acquired the information. In this case, when the information reading unit 87 acquires the information and transmits it to the control unit 82a, the information about the QC sample container 150 may be registered in the database 820 in association with the position number of the storage unit 841b.

[0241] 44A and 44B are diagrams showing the operation of the supply unit 80 in steps S301 to S306 of FIG. 35. As shown in FIG. 44A, when storing a 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. Because the first insertion port 831A is covered with a first cover 832A, the user must 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. When the transfer holder 834 is present at the first insertion port 831A, the lock of the first cover 832A is released, allowing the first cover 832A to be opened.

[0242] At the first insertion port 831A, the transfer holder 834 is detected by a sensor 835f. When the sensor 835f detects the transfer holder 834, for example, an 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 at the first insertion port 831A, it is possible to prevent a QC sample container 150 from being mistakenly inserted into a first insertion port 831A where the transfer holder 834 is not present.

[0243] 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 sensors 833e are installed 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 sensors 833e.

[0244] 44(b), the transfer holder 834 moves from the first insertion 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 placed in the storage section 87d, and the reading section 87c reads the QC sample ID from the machine-readable label 103.

[0245] As shown in Figure 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 all of the QC sample containers 150 have been transferred to the cold storage unit 84, the cold storage unit 84 closes the cover 842 and begins refrigerating and storing the QC sample containers 150. In the example of Figure 44(c), after all of 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 QC sample ID information is sent 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 QC sample ID information. Since the number of remaining tests for an unused QC sample container 150 is 24, 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.

[0246] 36 is a flowchart 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 input section 83A. In step S402, the control unit 82a controls the transfer unit 85 to remove the QC sample container 150 stored in the storage section 841b corresponding to the position number specified 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.

[0247] 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.

[0248] 37 to 39 are flowcharts showing the operation of the measurement unit. The operation of the measurement unit is mainly controlled by the control unit 31. Below, the operation will be described using the first measurement unit 10A as an example, but the same applies to the second measurement unit 10B.

[0249] 37 is a flowchart showing an example of the measurement procedure for the 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 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.

[0250] 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 removal position P2 is a sample container 100, the process proceeds to step S1104. If the container transported to removal position P2 is a QC sample container 150, the process proceeds to step S1201 in Figure 38, and if it is a detergent container 180, the process proceeds to step S1301 in Figure 39.

[0251] In step S1104, the control unit 31 queries 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 sample aspirating is completed, in step S1108, the sample container 100 is returned to its original storage unit 111 in the sample rack 110 by the robot hand 15.

[0252] 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 results of the initial test. If a retest is to be performed, the process returns to step S1105; if a retest is not to be performed, the results of the initial test are sent to the host computer 120 (step S1111). When the initial test and any necessary retests have been completed for all sample containers 100 contained 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).

[0253] 38 is a flowchart showing an example of the processing procedure when the container is a 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 receptacle 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.

[0254] 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 its original receptacle 111 in 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 this information. Information on the number of times the QC sample has been aspirated is used to update the number of remaining tests in the database 820. Alternatively, upon receiving this notification, the control unit 82a may update the database 820 by subtracting the number of remaining tests for the corresponding QC sample container 150.

[0255] If a retest to measure a QC sample again is set as a QC condition, the control unit 31 determines whether a retest is necessary (step S1207). For example, if the measured value is out of a predetermined allowable range, or if the error from the previous value is out of an allowable range, the control unit 31 determines that a retest is necessary if the measured value is abnormal. In this embodiment, it is assumed that a retest is performed automatically up to once. In other words, if steps S1201 to S1206 are repeated due to a retest, the process proceeds to step S1208 regardless of the result of the retest.

[0256] In step S1208, the control unit 31 determines whether 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.

[0257] When the control unit 31 outputs a 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 measurement unit in which the QC error occurred from transporting the sample container 100. Because the sample analysis system 1 includes multiple measurement units, the sample container 100 is supplied only to measurement units in which the QC sample measurement value is normal, and measurement units in which the QC sample measurement value is abnormal are excluded from the supply destination of the sample container 100. For example, if a QC error occurs in either measurement unit 10A or 10B of the upstream measurement block 10 in the sample analysis system 1 of FIG. 1, the transport controller 70 excludes the upstream measurement block from the supply destination of the sample container 100 and can supply the sample container only to the downstream measurement block 10. This prevents the sample from being erroneously measured by a measurement unit in which the QC error occurred and whose accuracy is not guaranteed. Furthermore, since measurement can be started by another normal measurement unit while the measurement unit in which the QC error occurred is being restored, this is highly convenient.

[0258] Based on the measurement values ​​of the QC samples, the control unit 31 creates a QC file (step S1210). As described above, the QC file is the measurement results of the QC samples 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 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.

[0259] When all measurements in the first measurement unit are completed (YES in step S1211), the control unit 31 updates the status of the first measurement unit based on the QC results (step S1212). The status can be, for example, standby or error. Standby is a state in which the measurement unit can measure samples. Error is a state in which an error has occurred in the measurement unit, making sample measurement impossible or prohibited. If the QC result is normal, i.e., there is no QC error, the control unit 31 sets the status of the measurement unit to standby. When a sample rack 110 containing a sample container 100 is transported, the control unit 31 is programmed to control the transport unit 20 so that the sample container 100 is supplied to a measurement unit whose status is standby. If a QC error occurs, the control unit 31 sets the status of the measurement unit to error. The control unit 31 is programmed not to supply samples to a measurement unit whose status is error. A measurement unit in which an error has occurred can be put into standby by, for example, having the user manually measure a QC sample or by performing error recovery.

[0260] The control unit 31 inquires of 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 the next measurement unit is the destination of the QC sample rack 160 (YES in step S1214), 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 via 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 via the belt 21b of the first transport path 21 (see FIG. 5). If 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).

[0261] 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 remove the cleaning agent container 180 from the storage unit 111 of the cleaning agent rack, and in step S1302, the control unit 31 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.

[0262] After a predetermined time has elapsed, the cleaning agent container 180 is returned to the rack (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 determines whether or not automatic shutdown is set to ON (step S1305). This determination is made based on the registered schedule information stored in the control unit 82a. If automatic shutdown is set to ON, for example, after processing of the used cleaning agent container 180 is completed, the control unit 82a turns off the power to the measurement unit 10A or 10B that has been cleaned (step S1306).

[0263] 40 is a flowchart 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 that is accessible from the outside so that a user can set a rack, and the user sets the sample rack 110 and the empty rack 170 on the first transport path 811. The rack set on the first transport path is detected by the sensor 818b.

[0264] In step S501, the control unit 82a controls the transport of a rack from the first transport path 811 to the second transport path 812, and detects a container using the sensor 818d. In step S502, the control unit 82a determines whether the rack set on the first transport path 811 is a sample rack 110 or an empty rack 170. The control unit 82a determines the type of rack based on whether or not a container is stored in the rack. If a container is detected, the control unit 82a determines that the rack is a sample rack, and if no container is detected, the control unit 82a determines that the rack is an empty rack. Note that the process in FIG. 40 is executed when a user sets a rack on the first transport path 811. In this embodiment, it is assumed that a QC sample rack 160 storing a QC sample container 150 will return to the supply unit 80 via the fifth transport path 815, and therefore, the determination in S501 does not include a branch corresponding to the QC sample rack 160.

[0265] 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 unit 88 and stored in the rack storage unit 88 (step S504).

[0266] Figure 45 is a diagram showing the operation of the supply unit 80 in steps S502 and S504 of Figure 40. As shown in Figure 45(a), when a user sets an empty rack 170 on the first transport path 811, the empty rack 170 is detected by sensor 818b and pushed out from the first transport path 811 to the right end of the second transport path 812 by the first sending unit 816A. Next, as shown in Figure 45(b), the empty rack 170 is detected by sensor 818c at the right end position of the second transport path 812, and is moved to the left end position by belt 812b of the second transport path 812 and detected by sensor 818e.

[0267] In the second transport path 812, when 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 again to the right end position of the second transport path 812 by belt 812b, as shown in FIG. 45(c). Then, as shown in FIG. 45(d), the empty rack 170 is detected by sensor 818c and drawn into the transport path 88a by transport arm 881. The empty rack 170 is drawn by transport arm 881 to the position of the front rack behind stopper 88c. At this time, stoppers 88b and 88c are lowered in conjunction with each other so as not to impede the transport of the empty rack 170.

[0268] 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 racks from the adjacent transport unit 20, and the QC sample rack 160 and the detergent rack return to the supply unit 80.

[0269] In step S601, the control unit 82a controls the second transport path 812 to transport the rack, and reads the IDs of the containers contained in the rack using the first information reading unit 817A and the second information reading unit 817B.

[0270] 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.

[0271] 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 again in the cold storage unit 84 (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 for 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. Note that in the above embodiment, the QC sample container 150 is stored again in step S602 regardless of the remaining amount. However, the QC sample container 150 may be processed based on, for example, the remaining amount information. For example, a QC sample container 150 with one or more remaining tests may be transported to the cold storage unit 84 for storage, and a QC sample container 150 with less than one remaining test may be transported to the first collection unit 89A for disposal.

[0272] 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).

[0273] 46 to 48 are diagrams for explaining in detail the process of determining the combination of QC sample containers 150 based on the QC conditions and information on the stored QC sample containers 150 in step S101 of Fig. 32. The following description will be given assuming that the QC sample containers 150 shown in the database 820 of Fig. 29 are stored in the cold storage section 84.

[0274] FIG. 46 shows cases A to C. <Case A> In Case A, the following QC conditions are set: Concentration level to use: Level 1, 2 - Units subject to quality control measurement: XN1, XN2, XN3, XN4 ·Block crossing: Yes

[0275] Block spanning is a setting regarding whether or not quality control measurements of multiple measurement blocks are performed using one QC sample rack 160. If block spanning 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 spanning is enabled or disabled can be changed according to user preference, such as whether to prioritize the efficiency of automatic QC or the ease of QC sample management.

[0276] For example, if block crossing is set to "unavailable," the QC sample rack 160 is transported to each of the multiple measurement blocks. Since quality control measurements can be performed in parallel for multiple measurement blocks, quality control measurements can be performed efficiently for the entire sample analysis system.

[0277] When block spanning 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 managing expiration dates and lot numbers complicated. In this regard, when block spanning is set to "enabled," the same QC sample container 150 is used in the first measurement block and the second measurement block, for example, which reduces the number of QC sample containers 150 consumed at one time and makes management easier.

[0278] In case A, since block spanning 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 currently in use. Here, the lot numbers currently in use are "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.

[0279] When the controller 82a determines that only one QC sample container 150 is available based on the lot number, it determines whether the number of remaining tests for that container is equal to or greater than the number of tests scheduled for automatic QC. As described above, if the number of remaining tests is less than the number of tests scheduled for automatic QC, the controller 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 controller 82a sets the identified QC sample container 150 in the rack.

[0280] If there are two or more QC sample containers 150 available based on the lot number, the automated QC determines 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 for execution. If the number of remaining tests is equal to or greater than the number of tests planned for execution, the identified container, i.e., the container with the fewest remaining tests, is set on the rack. If the number of remaining tests is less than the number of tests planned for execution, the automated QC determines whether the total number of remaining tests (total remaining number of tests) obtained by adding together the number of 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 for execution.

[0281] If the combined number of remaining tests is equal to or greater than the number of tests to be performed, the two QC sample containers 150 are set in the rack. If the combined number of remaining tests for the two QC sample containers 150 is less than the number of tests to be performed, the number of remaining tests for a third QC sample container 150 is added together and the same determination is repeated. If the combined number of remaining tests for all the QC sample containers 150 identified as usable based on the lot number is less than the number of tests to be performed, an automatic QC error is output and the schedule is canceled.

[0282] In Case A, four tests are required for Level 1, XN1 to XN4. Of the QC sample containers 150 in positions 1 and 2 identified based on the lot number, position 1, which has the fewest remaining tests, is used first. The remaining number of tests (3) in the QC sample container 150 in position 1 is compared with the number of tests planned to be performed (4). The remaining number of tests in the QC sample container 150 in position 1 is 3, which is less than the planned number of tests (4), so there is one test missing to perform quality control measurements at XN1 to XN4 using only the QC sample container 150 in position 1. Therefore, the total remaining number of tests (27), which is the sum of the remaining number of tests (24) in the QC sample container 150 in position 2, which has the second fewest remaining tests, and the remaining number of tests (3) in the QC sample container 150 in position 1, is compared with the planned number of tests (4). Since 27 tests is more than the number of tests planned to be performed, in this case, automatic QC errors are avoided and the QC sample containers 150 in positions 1 and 2 are combined and set in the rack. In other words, the QC sample containers 150 in positions 1 and 2 are combined and a level 1 quality control measurement is performed.

[0283] In Case A, four tests are also required for Level 2, with four units, 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 more than the number of tests planned 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.

[0284] Therefore, in case A, the QC sample containers 150 at position numbers 1, 2, and 4 are combined and set in one rack.

[0285] <Case B> In Case B, the following QC conditions are set: Concentration level to use: Level 2, 3 - Units subject to quality control measurement: XN1, XN2, XN3, XN4 ·Block crossing: Yes

[0286] 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.

[0287] For level 3, only the QC sample container 150 at position number 8 is stored in the refrigerated section 84. The QC sample container 150 at position number 8 has five remaining tests, which is greater than the four available tests, and therefore the QC sample container 150 at position number 8 is identified as the container to be used for quality control measurements.

[0288] Therefore, in case B, the QC sample containers 150 at positions 4 and 8 are combined and set in one rack.

[0289] <Case C> In Case C, the following QC conditions are set: Concentration levels to use: Levels 1, 2, 3 - Units subject to quality control measurement: XN1, XN2, XN3, XN4 ·Block crossing: Yes

[0290] In case C, the QC sample containers 150 at positions 1, 2, 4, and 8 are identified as the containers to be used for quality control measurements by the algorithm described above for cases A and B. Therefore, in case C, the four identified QC sample containers 150 are combined and set in one rack.

[0291] FIG. 47 shows cases D and E. <Case D> In Case D, the following QC conditions are set: Concentration level to use: Level 1, 2 - Units subject to quality control measurement: XN1, XN2, XN3, XN4 ·Block straddling: Not allowed

[0292] In case D, unlike case A, block crossing is set to "not allowed." In this case, one QC sample rack 160 is transported to only one measurement block. In other words, a different QC sample rack 160 must be transported to each measurement block.

[0293] 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 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 first QC sample rack 160 is set with a combination of QC sample containers 150 with position numbers 1 and 4, and the second QC sample rack 160 is set with a combination of QC sample containers 150 with position numbers 2 and 5.

[0294] <Case E> In Case E, the following QC conditions are set: Concentration level to use: Level 1, 2 - Units subject to quality control measurement: XN1, XN2, XN3, XN4 ·Block crossing: Yes Retest setting: Yes

[0295] Unlike Case A, Case E has an additional condition of "with retest." "With retest" means that if retesting is necessary as a result of measuring a QC sample, a retest will be performed automatically. Examples of situations where retesting is necessary include when, as a result of measuring a QC sample in the measurement unit, the measured value falls outside the allowable range, or when the error from the previous value falls outside the allowable range.

[0296] In Case E, if a retest is required as a result of quality control measurements performed by the automated QC, it is assumed that the retest will be performed automatically up to one time. In other words, it is assumed that one measurement unit will perform a maximum of two measurements on one QC sample container 150, including an initial test and a retest. After being removed from the refrigeration unit 84, the QC sample container 150 is heated in the heating unit 86 for a certain period of time (e.g., 15 minutes) before being used. Therefore, if 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, a new QC sample container 150 must be removed from the refrigeration unit 84 and heated for a certain period of time, resulting in a loss of time. Therefore, in this embodiment, if "retest setting enabled" is included in the QC conditions, the number of tests required for automatic retesting is set in the rack.

[0297] In case E, four measurement units, XN1 to XN4, are specified as targets. Therefore, for each concentration level, eight tests must be secured, including initial and retests. 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 positions 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 positions 4 and 5 are combined and set in the rack.

[0298] FIG. 48 shows case F. <Case F> In Case F, the following QC conditions are set: Concentration level to use: Level 1, 2 - Units subject to quality control measurement: XN1, XN2, XN3, XN4 ·Block crossing: Yes Lot-to-lot variation check: On

[0299] Unlike Case A, Case F has an additional condition: "Lot Difference Check Function On." The lot difference check function measures both the QC samples of the current lot and the QC samples of the new lot in a single automated QC schedule. When the QC sample lot is switched, both the QC samples of the current lot and the QC samples of the new lot may be measured using the same measurement unit for a certain period of time (e.g., one week) to compare the quality control results of the two lots. In other words, there may be a certain overlap between the usage periods of the current lot and the new lot. This is done to confirm that there is no significant deviation between the current lot and the new lot. The lot difference check function automatically performs automated QC using these two lots.

[0300] In case F, it is assumed that the QC sample list shown in Figure 48 is stored in the database 820 of the control unit 82a. As shown in Figure 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 the 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 the new lot. In this case, one lot in operation and one new lot are combined for each concentration level.

[0301] In case F, for example, on level 1, the QC sample containers 150 with position numbers 1 and 2 are combined, and on level 2, the QC sample containers 150 with position numbers 4 and 5 are combined. That is, a QC sample rack 160 containing the QC sample containers 150 with position numbers 1, 2, 4, and 5 is transported to measurement units XN1 to XN4, and four QC samples are measured in each measurement unit.

[0302] FIG. 49 shows an example of a screen 3000 for comparing quality control results between 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 also be provided elsewhere, such as in the measurement unit. The screen 3000 displays a QC chart 3001 for checking the daily variation in the measurement values ​​of the QC sample as the quality control results. As shown in FIG. 49, by reading the QC file of the old lot and the QC file of the new lot and performing the overlay operation, a QC chart 3002 of the old lot and a QC chart 3003 of the new lot can be displayed superimposed on each other. By comparing and checking the two QC charts, the user can check the lot-to-lot differences in the quality control results. The lot-to-lot difference check function of this embodiment allows for smooth lot switching, which is otherwise complicated.

[0303] 50 is a flowchart illustrating the processing of the supply unit 80 when a shutdown instruction is received. The control unit 82a determines whether 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 when the OK button is pressed on any of the screens 2100 to 2103. When the OK button is pressed on any of the screens, the control unit 82a determines that a shutdown instruction has been received (YES in step S700).

[0304] The control unit 82a determines the shutdown mode selected by the user (step S701). When a shutdown command is issued via the designated device screen 2101 of FIG. 20, the control unit 82a determines that the designated device mode is active and controls each part of the supply unit 80 to set the number of cleaning agent containers 180 corresponding to the number of devices specified on the screen 2101 in the rack and transport the cleaning agent rack toward the specified 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 the units are automatically powered off upon completion of cleaning using the cleaning agent. Although FIG. 39 illustrates an example of shutdown of the measuring units, the processing unit 40 is also automatically powered off after cleaning.

[0305] When the cleaning agent rack transported in step S702 returns, the control unit 82a stores the rack in the rack storage unit 88, controls each part of the supply unit 80 to 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.

[0306] When an instruction to shut down the entire system is given via the system screen 2102 of Figure 20, the control unit 82a determines that the entire system mode is in effect and controls each part of the supply unit 80 to transport detergent racks to all measurement units 10A, 10B and processing units 40 (step S704).

[0307] As in step S703, 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 discard the used detergent container 180 (step S705). The control unit 82a sends 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 shut down.

[0308] In step S707, the control unit 82a turns off the power to 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 samples continue to be stored in a cooled state.

[0309] When an instruction to shut down the supply unit 80 alone is given via the screen 2103 of FIG. 20, the control unit 82a skips steps S702 to S706, executes the process of step S707, and ends the process.

[0310] As described above, according to the sample analysis system 1 and quality control method described above, the quality control material is stored in a refrigerated state within the system, and the quality control measurement is automatically started, for example, during a time period when sample measurement is not affected. Therefore, when performing quality control measurement, the user does not need to set the quality control material in the system, reducing the burden on the user and greatly improving usability. In addition, since the quality control material stored in a refrigerated state is adjusted to the measurement temperature before being supplied to the measurement unit, the quality control material is measured at a stable temperature, enabling more reliable quality control measurement.

[0311] In addition to the above-described embodiments and modifications, the quality control method and sample analysis system according to the present invention can be modified in design as appropriate within the scope of the object of the present invention.

[0312] Figures 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 Figure 51, sample analysis system 1X differs from sample analysis system 1 in that a collection unit 60 is provided adjacent to the right side of supply unit 80, opposite module 10. In sample analysis system 1X, the rack transport path of collection unit 60 is connected to fifth transport path 815 of conveyor section 81. While third transport path 23 and fifth transport path 815 of transport unit 20 were transport paths for collecting QC sample racks 160 and detergent racks in sample analysis system 1, in sample analysis system 1X they are also used for collecting sample racks 110.

[0313] As shown in Figure 52, the sample analysis system 1Y differs from the sample analysis systems 1, 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 into which the user sets sample racks 110 and the like, and does not have a function for refrigerating and storing QC sample containers 150. In the example shown in Figure 52, the second supply unit 140 is disposed between the supply unit 80 and the collection unit 60. The rack transport path of the second supply unit 140 is connected to a sixth transport path 819 of the conveyor section 81. In this case, the sixth transport path 819 functions as a transport path for transporting sample racks 110 and the like from the second supply unit 140.

[0314] 53 and 54 are diagrams showing a supply unit 80K that is a first modified example. The supply unit 80K includes a conveyor unit 81K that includes a first transport path 811K on which a rack is set by a user. The configuration of the conveyor unit 81K is the same as that of the supply unit 80. The supply unit 80K further includes a cooling unit 84K, a transfer unit 85K, a heating unit 86K, a rack storage unit 88K, and a wagon 90K. While FIG. 54 shows a carousel-type cooling unit 84K, the configuration of these may be the same as that of the supply unit 80. Furthermore, configurations not shown, such as the information reading unit 86, may also be the same as that of the supply unit 80.

[0315] The supply unit 80K differs from the supply unit 83 of the supply unit 80 in the structure of the input section 83K, in which the QC sample containers 150 and detergent containers 180 are set. The input section 83K is disposed adjacent to the first transport path 811K and has a drawer-type structure that is slidable in the front-to-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.

[0316] The input unit 83K is configured to be manually pulled forward when the QC sample container 150 and the detergent container 180 are set in the supply unit 80K. Alternatively, the input unit 83K may be electrically operated. The input unit 83K is pulled toward the front of the device, the QC sample container 150 is set in the first storage unit 831K, and the input unit 83K is then pushed to a predetermined position at the rear of the device. As with the supply unit 80, the transfer unit 85K transfers the QC sample container 150 from the first storage unit 831K to the cooling unit 84K. The detergent container 180 is stored in the second storage unit 832K. The supply unit 80K is provided with, for example, a sensor that detects the number of detergent containers 180, and the number of detergent containers 180 is displayed in a detergent container inventory window 2006 shown in FIG. 19 .

[0317] Figure 55 is a schematic diagram showing a supply unit 80X as a second modified example. As shown in Figure 55, the supply unit 80X includes a first floor 81X provided with a transport path 811X for transporting the sample racks 110 and QC sample racks 160 to the measurement unit, and a second floor 82X provided with a cooling unit 84X, a detergent container storage unit 193, etc. The supply unit 80X also includes an elevator-type moving unit 190 that transports racks between the first floor 81X and the second floor 82X, and an information reading unit 194 that reads the rack ID and the sample IDs of the sample containers 100, etc., from the racks moving on the moving unit 190.

[0318] As in the supply unit 80, the second floor 82X is provided with a transfer section 85X for gripping and transferring the QC sample container 150, and an information reading section 87X for reading the QC sample ID of the QC sample container 150, and also houses a plurality of empty racks 170 for storing and transporting the QC sample containers 150 and detergent containers 180. The second floor 82X is also provided with a first loading and recovering section 191 that functions as an inlet and recovery port for the QC sample container 150, and a second loading and recovering section 192 that functions as an inlet and recovery port for the detergent container 180.

[0319] As described above, the QC sample container 150 is adjusted to the measurement temperature in the supply unit, then placed in a rack and transported to the measurement unit. However, if only some of the multiple measurement units are operating, it is preferable to transport the QC sample rack 160 only to the measurement units that are operating, and not to the measurement units that are idle.

[0320] The control unit of the supply unit may also measure the time T1 that the QC sample container 150 is removed from the refrigerated section 84 and placed in a room temperature environment, and execute a process to return the QC sample container 150 to the refrigerated 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 refrigerated section 84 without retesting, regardless of the measurement results of the QC sample, i.e., even if the measurement results are abnormal and retesting is set as a QC condition. This process prevents the QC sample from being placed in a room temperature environment for a long period of time, thereby maintaining the QC sample in good condition. Alternatively, the container may be discarded when the time T1 exceeds the predetermined time T2.

[0321] 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 predetermined continued use conditions, and discard the QC sample container 150 that does not satisfy the continued use conditions (for example, step S602 in FIG. 41). Alternatively, the QC sample container 150 that does not satisfy the continued use conditions may be returned to the cooling unit 84 and continue to be stored in a cooled state as unusable. Because QC samples are expensive, it may be undesirable to automatically discard the QC sample container 150, and this configuration can meet this need.

[0322] The 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 QC sample as well as the expiration date. For example, if the next quality control measurement is the next day, a QC sample container 150 whose expiration date is today may be discarded as it does not satisfy the continued use conditions.

[0323] The heating unit that heats the QC sample to adjust it to the measurement temperature may be equipped with devices that assist heating, such as a stirrer, a vibration generator, or a rotating device such as a carousel, in addition to a heater or a fan.

[0324] In the above embodiment, the QC sample is heated by heating the QC sample container 150 using the heating means of the heating unit 86, but it may also be heated by exposing the QC sample container 150 to a room temperature atmosphere. Also, in the above embodiment, the cooling unit 84 and the heating unit 86 are configured as separate devices and are provided in different locations, but it is also possible, for example, for the cooling unit to double as a heating unit. 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 cooling mode to heating mode to heat the QC sample.

[0325] 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 specimen 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]

[0326] 1. Sample analysis system 10 modules 10A First Measuring Unit 10B Second measurement unit 20 Transport unit 21 First conveying path 22 Second conveying path 23 Third transport route 30 Control Unit 40 processing units 50 transport units 60 Recovery Unit 70 Transport Controller 80 supply units 81 Conveyor section 811 First conveyor route 812 Second conveying 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 Second cover 834 Transfer Holder 839 Removal section 84 Cooling section 85 Transfer section 86 Heating section 87 Information reading unit 88 Rack storage area 89A First Recovery Section 89B Second Recovery Section 90 Wagon 91 Monitor 100 specimen containers 110 sample racks 120 Host Computer 130 Concentrator 150 QC sample containers 160 QC sample racks 170 empty racks 180 detergent container

Claims

1. A measurement method in a sample analysis system comprising: a blood cell analyzer for measuring blood samples contained in first containers; a common supply unit including a cooling unit, a heating unit, and a transport unit, which supplies the first containers to second containers containing a quality control substance containing cells of a known concentration; and a transport unit, (1) To perform the measurement of the blood sample, (1-1) supplying the first container by the supply unit; (1-2) transporting the first container from the supply unit to the blood cell analyzer via the transport unit; (1-3) measuring the blood sample contained in the first container with the blood cell analyzer; (2) To automatically perform quality control measurements to ensure the measurement accuracy of the blood sample, (2-1) storing the second container in the cold storage section; (2-2) removing the second container from the cooling unit by the transfer unit and transferring the removed second container to the heating unit; (2-3) the transport unit transports the heated second container to the blood cell analyzer; (2-4) A method for measuring the quality control material contained in the second container using the blood cell analyzer.

2. The method according to claim 1 , wherein the second container is returned to the cooling section by the transfer section after the measurement of the quality control substance in the blood cell analyzer is completed.

3. The method according to claim 1 or 2, wherein the second container is grasped or released by a pair of arms of the transfer unit.

4. The method according to any one of claims 1 to 3, wherein the heated second container is removed from the heating unit by the transfer unit and placed in a rack.

5. placing the heated second container in a rack; The method according to any one of claims 1 to 4, wherein the second container is transported to the blood cell analyzer by transporting the rack in which the second container is housed.

6. A method according to any one of claims 1 to 5, wherein heating the quality control material includes holding the second container for a predetermined period of time in a heating unit capable of holding and heating the second container.

7. placing the heated second container in a rack; the second container is transported to the blood cell analyzer by transporting the rack in which the second container is accommodated; The method according to any one of claims 1 to 6, wherein the rack is stored in a rack storage unit.

8. The method according to claim 7 , wherein after the measurement of the quality control substance in the blood cell analyzer is completed, the rack is returned to the rack housing section, and the second container is returned from the rack to the cooling section.

9. A method according to any one of claims 1 to 8, wherein if the measurement result of the quality control substance in the blood cell analyzer is normal, the second container containing the quality control substance is returned to the refrigeration section, and if the measurement result is abnormal, the quality control substance is re-measured in the blood cell analyzer.

10. A method according to any one of claims 1 to 9, wherein when the quality control material is left in a room temperature environment for a predetermined time, the second container containing the quality control material is returned to a cold storage section for storing the quality control material in a refrigerated state.

11. The method according to any one of claims 1 to 10, wherein the sample analysis system includes a plurality of blood cell analyzers, and the second container containing the quality control material adjusted to the measurement temperature is transported to one of the plurality of blood cell analyzers that is in operation, but is not transported to one of the blood cell analyzers that is inactive.

12. Schedules for automatically measuring quality control substances are stored, The method according to any one of claims 1 to 11, wherein the heating of the quality control material is initiated according to the schedule.

13. The method according to any one of claims 1 to 12, wherein the quality control material comprises blood cells.

14. A blood cell analyzer for analyzing a blood sample contained in a first container; a common supply unit that supplies the first container and a second container containing a quality control material containing cells of a known concentration to the blood cell analyzer, a cold storage unit that cools and stores the second container; a heating unit that heats the quality control material contained in the second container; a supply unit including a transfer unit that holds and transfers the second container from the cooling unit to the heating unit; a transport unit that transports the heated second container to the blood cell analyzer; Equipped with (1) To perform the measurement of the blood sample, (1-1) the transport unit transports the first container to the blood cell analyzer; (1-2) The blood cell analyzer measures the blood sample contained in the first container; (2) To automatically perform the quality control measurement, (2-1) the supply unit takes out the second container from the cooling unit and heats the taken-out second container by the heating unit; (2-2) the transport unit transports the second container to the blood cell analyzer; (2-3) A sample analysis system in which the blood cell analyzer measures the quality control material contained in the second container.

15. The sample analyzing system according to claim 14 , wherein the transport unit returns the second container to the cooling unit after the measurement of the quality control substance in the blood cell analyzer is completed.

16. The sample analyzing system according to claim 14 or 15, wherein the transport unit removes the second container, which is stored in a cooled state, from the cooling unit using a pair of arms and transports the second container to the heating unit.

17. Further provided is a rack accommodating unit that stores a rack for accommodating the second container, The sample analysis system of any one of claims 14 to 16, wherein the transport unit stores the heated second container in the rack and transports it to the blood cell analyzer, and after measurement of the quality control material is completed, returns the rack to the rack storage unit and returns the second container from the rack to the cooling unit.

18. the cooling unit cools and stores a plurality of quality control substances including two or more types of quality control substances having different concentrations; The sample analysis system according to any one of claims 14 to 17, wherein the transfer unit and the transport unit store the two or more types of quality control substances in the rack and transport them to the blood cell analyzer.

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