Precision management assistance method, system, device, and storage medium containing corresponding program
By generating and displaying management charts of precision management substances and tested object samples, the problem of difficulty in determining the cause of abnormal measurement results in existing technologies is solved, and the identification of abnormal causes at different measurement frequencies is realized.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- SYSMEX CORP
- Filing Date
- 2021-07-28
- Publication Date
- 2026-05-05
AI Technical Summary
Existing technologies are insufficient to track the measurement results of precision-managed substances in the short term, and are also insufficient to track the measurement results of tested samples in the long term, making it difficult to determine the cause when measurement results are abnormal.
The measurement results of the precision-managed substance are represented by a first management chart, and a second management chart is displayed in different specified second periods. The second period is shorter than the first period and at least partially overlaps with the first period. The display period is adjusted according to the difference in measurement frequency between the precision-managed substance and the test sample.
It makes it easier to determine the cause when the measurement results are abnormal, and improves the efficiency of identifying the cause of the abnormality by adjusting the display period to adapt to different measurement frequencies.
Smart Images

Figure CN114067984B_ABST
Abstract
Description
Technical Field
[0001] This invention relates to a precision management auxiliary method, a precision management auxiliary system, a precision management auxiliary device, and a program. Background Technology
[0002] Known precision management methods include: methods using a control chart based on the Levey-Jennings (LJ) method, where the control chart represents the measurement results of a precision management substance prepared to obtain a certain measurement value in a time series; and methods using a control chart that shows the shift in the average value of the measurement results of the tested sample without using a precision management substance. Sometimes, by confirming these control charts, it can be determined whether the cause of abnormal measurement results lies with the analytical device, the reagents used in the analytical device, or the precision management substance. For example, Non-Patent Literature 1 describes a method that displays the following control charts as auxiliary precision management: a control chart based on the LJ method; and a control chart showing the shift in the average value of the measurement results of the tested sample within the same period as the display period of the control chart (a control chart representing the results of PBRTQC (Patient-Based Real Time Quality Control)).
[0003] Existing technical documents
[0004] Patent documents
[0005] Non-technical literature 1: Lo TP, Cervinski MA, et al., "Recommendations for laboratory informatics specifications needed for the application of patient-based real time quality control", Clinica Chimica Acta, 2019 Aug, 495, Page.625-629. Summary of the Invention
[0006] The technical problem that the invention aims to solve
[0007] However, the number of measurements of precision-controlled substances (drawing control charts based on the LJ method) is generally one to three times a day, while the number of measurements for the tested sample can sometimes be dozens to hundreds of times. In the method described in Non-Patent Literature 1, both a control chart based on the LJ method and a control chart representing the results of PBRTQC are displayed within the same period. Therefore, if the display period is short, it is difficult to grasp the progression of measurement results for precision-controlled substances over a period such as two weeks; if the display period is long, it is difficult to grasp the progression of measurement results for the tested sample over a short period such as one day. Therefore, even when using the method described in Non-Patent Literature 1, it is difficult to determine the cause when measurement results are abnormal.
[0008] The present invention aims to provide an accuracy management auxiliary method, accuracy management auxiliary system, accuracy management auxiliary device and program that makes it easy to determine the cause when the measurement results are abnormal.
[0009] Technical means to solve technical problems
[0010] One aspect of the present invention relates to a precision management assistance method for displaying a precision management management chart related to an analytical device for measuring a sample of a test object. The method includes: generating a first management chart representing the results obtained by measuring a precision management substance through the analytical device during a first period; specifying a second period, different from the first period, which is shorter than the first period and at least partially overlaps with the first period; generating a second management chart representing the results obtained by measuring the sample of the test object through the analytical device during the second period; displaying the generated first management chart; and displaying the generated second management chart.
[0011] According to the above-described technical form, the aforementioned accuracy management assistance method displays a first management chart during a first period using an analytical device, and accepts the designation of a second period that is shorter than the first period and at least partially overlaps with the first period, different from the designated first period, and displays a second management chart during the second period. Therefore, in the aforementioned accuracy management assistance method, the first and second management charts are displayed during a display period corresponding to the difference between the measurement frequency of the accuracy management substance and the measurement frequency of the tested sample. This allows for easy identification of the cause when measurement results are abnormal. Accepting the designation of the second period differently from the designated first period means accepting the designation of the second period differently from either a first period that is pre-set as a default period or an arbitrarily designated first period. When an arbitrarily designated first period is used, the time points for accepting the designations of the first and second periods can be either different or simultaneous.
[0012] Furthermore, one aspect of the present invention relates to a precision management assistance method for displaying a precision management management chart related to an analytical device for measuring a sample of a test object. This method includes: generating a first management chart representing the results obtained by measuring a precision management substance through the analytical device during a first period; generating a second management chart representing the results obtained by measuring the sample of the test object through the analytical device during a second period, a portion of the first period; and arranging and displaying the first and second management charts.
[0013] According to the aforementioned technical configuration, the precision management assistance method displays a first management chart during a first period and a second management chart during a second period within the first period, with the first and second management charts displayed in an alternating manner. Therefore, in this precision management assistance method, the first and second management charts are displayed in an alternating manner according to the difference between the measurement frequency of the precision management substance and the measurement frequency of the tested sample. Thus, because the first and second management charts are displayed in an alternating manner, the cause can be more easily determined when the measurement results are abnormal.
[0014] One aspect of the present invention relates to a precision management assistance system that displays a management chart related to the precision management of an analytical device for measuring a sample of a test object. The system includes: a precision management assistance device having a first control unit; and a terminal device connected to the precision management assistance device via a network, having a second control unit and a display. The first control unit of the precision management assistance device performs the following actions: generating a first management chart representing the results obtained by measuring a precision-managed substance using the analytical device during a first period; accepting the designation of a second period different from the first period, the second period being shorter than the first period and at least partially overlapping with the first period; and generating a second management chart representing the results obtained by measuring the sample of the test object using the analytical device during the second period. The second control unit of the terminal device performs the following actions: displaying the generated first management chart on the display; and displaying the generated second management chart on the display.
[0015] According to the above-described technical form, the precision management auxiliary system displays a first management chart during a first period via an analytical device, and, different from the specified first period, accepts a second period that is shorter than the first period and at least partially overlaps with the first period, and displays a second management chart during the second period. Therefore, in the above-described precision management auxiliary system, the first and second management charts are displayed for a display period corresponding to the difference between the measurement frequency of the precision management substance and the measurement frequency of the tested sample. Therefore, the cause can be easily determined when the measurement results are abnormal.
[0016] One aspect of the present invention relates to a precision management auxiliary device that displays a precision management chart related to an analytical device for measuring a sample of a test object. The device includes a control unit and a display. The control unit performs the following actions: generating a first management chart representing the results obtained by measuring a precision management substance using the analytical device during a first period; accepting the designation of a second period different from the first period, the second period being shorter than the first period and at least partially overlapping with the first period; generating a second management chart representing the results obtained by measuring the sample of the test object using the analytical device during the second period; displaying the generated first management chart on the display; and displaying the generated second management chart on the display.
[0017] According to the above-described technical form, the aforementioned precision management auxiliary device displays a first management chart during a first period via an analysis device, and, different from the specified first period, accepts a second period that is shorter than the first period and at least partially overlaps with the first period, displays a second management chart during the second period. Therefore, in the aforementioned precision management auxiliary device, the first and second management charts are displayed during a display period corresponding to the difference between the measurement frequency of the precision management substance and the measurement frequency of the tested sample. This allows for easy identification of the cause when measurement results are abnormal.
[0018] Furthermore, one aspect of the present invention relates to a precision management auxiliary device that is connected to a terminal device equipped with a display via a network, and displays a precision management chart related to the analytical device used to measure the sample of the test object on the display of the terminal device. The control unit performs the following actions: generating a first management chart, which represents the results obtained by measuring a precision management substance using the analytical device during a first period; accepting a designation of a second period different from the first period, the second period being shorter than the first period and at least partially overlapping with the first period; generating a second management chart, which represents the results obtained by measuring the sample of the test object using the analytical device during the second period; transmitting the generated first management chart to the terminal device; and transmitting the generated second management chart to the terminal device.
[0019] According to the above-described technical form, the precision management auxiliary device generates a first management chart during a first period using an analysis device, and then, unlike the first period, accepts a second period that is shorter than the first period and overlaps with it at least partially, generates a second management chart during the second period. The precision management auxiliary device transmits both the generated first and second management charts to a terminal device. Therefore, in a terminal device connected to the precision management device via a network and equipped with a display, the first and second management charts are displayed during a display period corresponding to the difference between the measurement frequency of the precision management substance and the measurement frequency of the tested sample. Thus, the cause can be easily determined when the measurement results are abnormal.
[0020] One aspect of the present invention relates to a procedure that causes a precision management aid device to perform the following: the precision management aid device displays a precision management chart related to an analytical device measuring a sample of a test object on a display of a terminal device connected via a network: generating a first management chart, the first management chart representing the results obtained by measuring a precision management substance by the analytical device in a first period; accepting the designation of a second period different from the first period, the second period being shorter than the first period and at least partially overlapping with the first period; generating a second management chart, the second management chart representing the results obtained by measuring the sample of the test object by the analytical device in the second period; transmitting the generated first management chart to the terminal device; and transmitting the generated second management chart to the terminal device.
[0021] According to the above-described technical form, the above-described procedure causes the precision management auxiliary device to perform the following: generate a first management chart during a first period using an analysis device; accept a designation of a second period that is shorter than the first period and overlaps with the first period at least partially, unlike the designation of the first period; and generate a second management chart during the second period. The above-described procedure causes the precision management auxiliary device to perform the following: transmit the generated first management chart to a terminal device; and transmit the generated second management chart to the terminal device. Therefore, in a terminal device connected to the precision management auxiliary device via a network and equipped with a display, the first and second management charts are displayed during a display period corresponding to the difference between the measurement frequency of the precision management substance and the measurement frequency of the tested sample. Therefore, the cause can be easily determined when the measurement results are abnormal.
[0022] Furthermore, a procedure according to one aspect of the present invention enables a precision management auxiliary device, which displays a precision management management chart related to the analytical apparatus used to measure a sample of a test subject and has a display, to perform the following: generating a first management chart by the analytical apparatus during a first period, the first management chart representing the result obtained by measuring a precision management substance; accepting the designation of a second period different from the first period, the second period being shorter than the first period and at least partially overlapping with the first period; generating a second management chart during the second period, the second management chart representing the result obtained by measuring the sample of the test subject by the analytical apparatus; displaying the generated first management chart on the display; and displaying the generated second management chart on the display.
[0023] According to the above-described technical form, the above-described procedure causes the precision management auxiliary device to perform the following: generate a first management chart during a first period using an analytical device; accept the designation of a second period different from the first period, the second period being shorter than the first period and at least partially overlapping with the first period; generate a second management chart during the second period; display the generated first management chart on a display; and display the generated second management chart on a display. Therefore, the above-described procedure causes the precision management auxiliary device to display the first and second management charts during a display period corresponding to the difference between the measurement frequency of the precision management substance and the measurement frequency of the tested sample. Therefore, the cause can be easily determined when the measurement results are abnormal.
[0024] Invention Effects
[0025] This invention provides an accuracy management aid that makes it easy to determine the cause of abnormal measurement results. Attached Figure Description
[0026] Figure 1 This is a schematic diagram of an example of the structure of the accuracy management assistance system according to the first embodiment;
[0027] Figure 2 This is a schematic diagram illustrating an example of the structure of the accuracy management auxiliary device and the responsible person terminal according to the first embodiment;
[0028] Figure 3(A) is a schematic diagram of an example of the collection and processing of measurement data in a blood cell counting device for QC (Quality Control) assays.
[0029] Figure 3(B) is a schematic diagram of an example of the collection and processing of measurement data for a sample of a test subject in a blood cell counting device;
[0030] Figure 4 This is an example flowchart of the display process of the QC (Quality Control) chart according to the first embodiment;
[0031] Figure 5(A) is a schematic diagram of an LJ diagram;
[0032] Figure 5(B) is a schematic diagram of an XbarM plot;
[0033] Figure 6(A) is an example of an LJ plot and an XbarM plot;
[0034] Figure 6(B) is a schematic diagram of an XbarM plot;
[0035] Figure 7 This is a schematic diagram of an example of the XbarM diagram according to the first embodiment;
[0036] Figure 8(A) is an example of an LJ plot and an XbarM plot;
[0037] Figure 8(B) is an example of an XbarM diagram displayed when a certain operation is performed on the XbarM diagram in Figure 8(A);
[0038] Figure 8(C) is an example of an XbarM diagram displayed when a certain operation is performed on the XbarM diagram in Figure 8(B);
[0039] Figure 9 This is an example of an LJ plot and an XbarM plot;
[0040] Figure 10 This is another example of an LJ plot and an XbarM plot;
[0041] Figure 11 This is a schematic diagram of an example of the LJ diagram and XbarM diagram involved in the first embodiment;
[0042] Figure 12 This is another schematic diagram illustrating the display processing of the LJ diagram and XbarM diagram according to the first embodiment;
[0043] Figure 13 This is another schematic diagram illustrating the display method of the LJ diagram and XbarM diagram according to the first embodiment;
[0044] Figure 14(A) is an example of a schematic diagram of a specified interface during the display of an XbarM chart;
[0045] Figure 14(B) is an example schematic diagram of an LJ chart corresponding to the period specified by the interface in the display period of the XbarM chart shown in Figure 14(A);
[0046] Figure 15(A) is a schematic diagram of a specific area size control in the LJ diagram;
[0047] Figure 15(B) is a schematic diagram of a specific area location control in the LJ diagram;
[0048] Figure 16 This is another schematic diagram of the QC diagram involved in the first embodiment;
[0049] Figure 17 This is a schematic diagram of an example of the LJ diagram and XbarM diagram according to the first embodiment, which is a diagram in which the display period of the XbarM diagram is set to be shorter than the display period of the LJ diagram;
[0050] Figure 18 This is a schematic diagram of an example of the XbarM diagram according to the first embodiment;
[0051] Figure 19(A) is an example schematic diagram showing the LJ chart during a specified display period;
[0052] Figure 19(B) is an example schematic diagram of an XbarM plot within a display period corresponding to a specific period in the LJ plot of Figure 19(A);
[0053] Figure 20 This is a schematic diagram of an example of an LJ diagram according to the second embodiment;
[0054] Figure 21 This is an example flowchart of the QC diagram display process according to the second embodiment;
[0055] Figure 22 This is a schematic diagram of an example of the structure of the accuracy management assistance system according to the third embodiment;
[0056] Figure 23 This is an example flowchart of the display processing of the QC diagram according to the third embodiment;
[0057] Figure 24 This is another schematic diagram illustrating the structure of a precision management assistance system according to one embodiment. Detailed Implementation
[0058] Preferred embodiments of the present invention will now be described with reference to the accompanying drawings. Furthermore, the same symbols are used to refer to the same elements, and repeated descriptions are omitted. Additionally, unless otherwise stated, positional relationships such as top, bottom, left, and right are based on the positional relationships shown in the accompanying drawings. Furthermore, the scale of the accompanying drawings is not limited to the scale shown. Moreover, the following embodiments are examples used to illustrate the present invention, and the present invention is not limited to these embodiments.
[0059] [First Implementation]
[0060] Figure 1 This is a schematic diagram illustrating an example of the structure of the accuracy management assistance system according to the first embodiment. For example... Figure 1As illustrated, for example, the accuracy management assistance system 100 includes: an accuracy management assistance device 1 configured in a support center, a blood cell counting device 3A and a manager terminal 5A configured in facility A, and a blood cell counting device 3B and a manager terminal 5B configured in facility B. The accuracy management assistance device 1 is a device for generating display information used to display and / or enable other computers to display various graphs (management graphs) related to the accuracy management of the blood cell counting device 3 used to measure the sample of the test subject.
[0061] The blood cell counting device 3 is a device for measuring samples of the tested object. The blood cell counting device 3 performs one or two measurements related to precision management substances (QC measurements) per day, for example. Alternatively, the blood cell counting device 3 performs dozens to hundreds of measurements related to the tested object samples per day. The supervisor's terminal 5 is a device operated by personnel working in the facility, which performs various processes related to the overall management of the facility. The supervisor's terminal 5 receives input from the supervisor, which is an indication of the display of various graphs related to precision management of the blood cell counting device 3, or input related to the display period. Upon receiving this input, the supervisor's terminal 5 transmits the corresponding control signal to the precision management auxiliary device 1. If the supervisor's terminal 5 receives information for displaying various graphs generated by the precision management auxiliary device 1, it displays these graphs on its display screen based on this information.
[0062] The accuracy management assistance system 100 includes an accuracy management assistance device 1 and a supervisor terminal 5A, thus enabling the processing to be distributed between the accuracy management assistance device 1 and the supervisor terminal 5A. Therefore, in the supervisor terminal 5A, the speed reduction of processing other than the display of various graphs, such as viewing inspection results and generating inspection reports, can be suppressed.
[0063] Facility A and Facility B each include, for example, a clinical laboratory or a clinical trial center. Without distinguishing between Facility A and Facility B, they are collectively referred to as "facilities" below. There can be two or fewer facilities, or three or more. In the first embodiment, each facility is managed by a different management entity. As will be stated later in the second embodiment, among several facilities, two or more facilities can be managed by the same operating entity. Furthermore, without distinguishing between blood cell counting device 3A and blood cell counting device 3B, they are collectively referred to as "blood cell counting device 3" (analytical device). Further, without distinguishing between responsible terminal 5A and responsible terminal 5B, they are collectively referred to as "responsible terminal 5". Moreover, there can be two or more blood cell counting devices 3 and responsible terminals 5 located in each facility.
[0064] Each facility and support center (accuracy management auxiliary device 1) is connected to each other via a communication network N. In facility A, the blood cell counting device 3A and the responsible terminal 5A are connected to each other via a communication network NA. In facility B, the blood cell counting device 3B and the responsible terminal 5B are connected to each other via a communication network NB. Each communication network has wired and / or wireless networks.
[0065] Figure 2 This is a schematic diagram illustrating an example of the hardware structure of the accuracy management auxiliary device 1 and the responsible terminal 5 according to the first embodiment. Figure 2 As shown, the precision management auxiliary device 1 includes, for example, a processor 11 (control unit), a memory 12, a storage device 13, a communication device 14, an input device 15, and an output device 16.
[0066] The processor 11 is configured to control the operation of each part of the auxiliary device 1 with precise control. The processor 11 may include integrated circuits such as a CPU (Central Processing Unit), DSP (Digital Signal Processor), ASIC (Application Specific Integrated Circuit), PLD (Programmable Logic Device), FPGA (Field Programmable Gate Array), or SoC (System-on-a-chip). The processor 11 performs various functions, such as display processing, by executing programs stored in the memory 12 or storage device 13.
[0067] The memory 12 is primarily used as a temporary storage area for data processing. The storage device 13 primarily stores programs and large amounts of data. The memory 12 may include, for example, ROM (Read-Only Memory), EPROM (Erasable Programmable ROM), EEPROM (Electrically Erasable Programmable Memory), and / or RAM (Random Access Memory). The storage device 13 may include, for example, HDD (Hard Disk Drive), SSD (Solid State Drive), and / or eMMC (embedded Multi Media Card), etc.
[0068] Communication device 14 is introduced Figure 1 The communication network N shown communicates with the blood cell counting devices 3 and the responsible terminal 5 of each facility. The communication device 14 may include, for example, a network card and a communication module. Alternatively, the communication device 14 may also include an amplifier and an RF (Radio Frequency) device for processing wireless signals.
[0069] The input device 15 is configured to allow information to be input via user operation at the support center. The input device 15 may include, for example, a keyboard, a pointing device, and / or a microphone. Examples of pointing devices include a mouse, trackball, touchpad, and touchscreen.
[0070] The output device 16 is configured to output information. The output device 16 may include, for example, a liquid crystal display, an EL (Electroluminescence) display, a plasma display, or a speaker. Additionally, the output device 16 may also have the functions of an input device 15. For example, the output device 16 may be a device equipped with a touchscreen display.
[0071] The terminal 5A for the person in charge, like the precision management auxiliary device 1, has a processor 11 (control unit), a memory 12, a storage device 13, a communication device 14, an input device 15, and an output device 16.
[0072] Figure 3 is a schematic diagram illustrating an example of the data collection and processing of a blood cell counting device according to one embodiment. Figure 3(A) is a schematic diagram illustrating an example of the data collection and processing of the QC (precision management) measurement processing of the blood cell counting device 3. Figure 3(B) is a schematic diagram illustrating an example of the data collection and processing of the measurement processing of patient samples (subject samples) of the blood cell counting device 3.
[0073] As shown in Figure 3(A), each blood cell counting device 3 transmits a specific dataset, including the results of the measurement process, related to the precision management substance to the precision management auxiliary device 1. The transmitted dataset includes, in association, the device ID of the blood cell counting device 3, the measurement date, the batch number of the precision management substance, and the measured value. After the measurement is completed, the relevant measurement results of the precision management substance are transmitted to the precision management auxiliary device 1. For example, the relevant measurement results of the precision management substance can be transmitted daily. The transmission time point for the relevant measurement results of the precision management substance can be set for each facility and each blood cell counting device.
[0074] As shown in Figure 3(B), each blood cell counting device 3 transmits a certain dataset, including the results of the measurement processing, related to the sample being tested to the accuracy management auxiliary device 1. The transmitted dataset includes, in association, the device ID of the blood cell counting device 3, the measurement date, and the measurement value. After a certain number of measurements (e.g., twenty samples) are completed, the results of the relevant measurement processing of the sample being tested are transmitted to the accuracy management auxiliary device 1. Furthermore, a certain number can be set for each facility. The datasets transmitted from each blood cell counting device 3, as shown in Figures 3(A) and (B), are stored in the storage device 13 of the accuracy management auxiliary device 1.
[0075] The datasets shown in Figures 3(A) and (B) may also include at least one of the following related information: the occurrence of an error in the blood cell counting device 3; the implementation of calibration of the blood cell counting device 3; and the replacement of reagents in the blood cell counting device 3. Information related to the occurrence of an error in the blood cell counting device 3 may include, for example, the date of the error and the content of the error. Information related to the implementation of calibration of the blood cell counting device 3 may include, for example, the date of calibration and the content of the calibration. Information related to the replacement of reagents in the blood cell counting device 3 may include, for example, the date of reagent replacement and identification information of the reagents before and after replacement. Furthermore, the transmission format of the datasets shown in Figures 3(A) and (B) is arbitrary; for example, it may be constructed in the form of a data packet.
[0076] Figure 4 This is an example flowchart of the QC chart display process according to the first embodiment. For example... Figure 4 As shown, QC chart display processing is performed between the responsible terminal 5 and the accuracy management auxiliary device 1. Furthermore, as a prerequisite, as illustrated using Figure 3, the measurement data obtained from each facility via the blood cell counting device 3 has been transmitted to the accuracy management auxiliary device 1 as part of a certain dataset. The accuracy management auxiliary device 1 stores the received measurement data in... Figure 2 The storage device 13 shown.
[0077] (Step S1)
[0078] The processor 11 of the supervisor terminal 5 (hereinafter referred to as supervisor terminal 5) operated by the person in charge of the facility determines whether a designation has been accepted by the person in charge, the designation being related to the display period of the QC charts (such as LJ charts and XbarM charts) displayed on the accuracy management auxiliary device 1. If the designation has been accepted (yes in step S1), the process proceeds to step S2; if the designation has not been accepted (no in step S1), the process proceeds to step S10. Here, the LJ chart is a management chart that uses time series to represent the results obtained from measuring the accuracy management substance, and the XbarM chart is a management chart that uses time series to represent the results obtained from measuring the sample of the test object.
[0079] Specify a display period for the LJ chart and XbarM chart. For example, specifying December 27, 2019 to January 5, 2020 as the display period for the LJ chart will display both the LJ chart and XbarM chart. Figure 2 The period from December 27, 2019 to January 5, 2020 will be used as the display period. That is, the display period of the LJ chart will be automatically set to the display period of the XbarM chart.
[0080] (Step S2)
[0081] The responsible person's terminal 5 determines whether the display indications of the LJ diagram and XbarM diagram have been accepted by the responsible person. If the designation has been accepted (yes in step S2), the process proceeds to step S3; if the designation has not been accepted (no in step S2), the responsible person's terminal 5 remains in standby mode until the designation is accepted.
[0082] (Step S3)
[0083] The responsible terminal 5 transmits the instructions for creating the display data to the accuracy management auxiliary device 1 based on the received display instructions.
[0084] (Step S4)
[0085] The processor 11 of the precision management auxiliary device 1 (hereinafter referred to as precision management auxiliary device 1) determines whether it has received a production instruction for display data from the person in charge terminal 5. If the instruction has been received (yes in step S4), the process proceeds to step S5; if the instruction has not been received (no in step S4), the process proceeds to step S12.
[0086] (Step S5)
[0087] Precision Management Auxiliary Device 1 Figure 2 The storage device 13 shown reads the measurement data from the pre-stored blood cell counting device 3. For example, the accuracy management auxiliary device 1 reads and displays the QC measurement results and the test sample measurement results for the period corresponding to December 27, 2019 to January 5, 2020.
[0088] (Step S6)
[0089] The accuracy management auxiliary device 1 determines QC measurement results outside the permissible range. As illustrated in Figure 5 below, the accuracy management auxiliary device 1 can, for example, determine measurement data exceeding the upper limit value 1 and measurement data below the lower limit value 1. The accuracy management auxiliary device 1 can, for example, control the determination of measurement data so that it is not reflected in the graph.
[0090] (Step S7)
[0091] The accuracy management auxiliary device 1 generates information for displaying the LJ chart and XbarM chart on the display of the responsible terminal 5, and transmits this information to the responsible terminal 5. Furthermore, the accuracy management auxiliary device 1 can... Figure 2 The output device 16 shown displays the LJ diagram and the XbarM diagram.
[0092] (Step S8)
[0093] The responsible terminal 5 determines whether it has received display data for displaying the LJ chart and XbarM chart from the accuracy management auxiliary device 1. If display data has been received (yes in step S8), the process proceeds to step S9; if display data has not been received (no in step S8), the responsible terminal 5 remains in standby mode until it receives data.
[0094] (Step S9)
[0095] The responsible terminal 5 displays the LJ graph and XbarM graph within the display period specified in step S1 (corresponding to the period from December 27, 2019 to January 5, 2020) based on the received display data.
[0096] Figure 5(A) is a schematic diagram of an LJ diagram. Figure 5(B) is a schematic diagram of an XbarM diagram. As shown in Figures 5(A) and (B), the responsible terminal 5 displays the LJ diagram (first management diagram) and XbarM diagram on the display screen during the display period from December 27, 2019 to January 5, 2020.
[0097] As shown in Figure 5(A), the LJ chart is a graph created by plotting the measurement results of the precision management substance (QC sample) measured by the blood cell counting device 3 using a time series plot. As shown in Figure 5(A), the precision management substance is measured once to several times a day. The "target value" (e.g., "30") in the LJ chart refers to the standard value determined for each batch of QC samples. In addition, the "upper limit 1" and "lower limit 1" in the LJ chart are the upper and lower limits determined for each batch of QC samples, respectively. When measurement results outside the range ("27" to "33") specified by the "upper limit 1" and "lower limit 1" in the LJ chart are reflected on the LJ chart, identification information corresponding to "(!) Error" is added to the measurement result. The "upper limit 2" and "lower limit 2" in the LJ chart are, for example, values set corresponding to the values of the "upper limit 1" and "lower limit 1", respectively. For example, the "upper limit 2" can be set to a value that corresponds to approximately 97% of the "upper limit 1". The "Upper Limit Value 2" and "Lower Limit Value 2" can be freely set by the user. When the measurement results within the range specified by "Upper Limit Value 1" and "Upper Limit Value 2" ("32" to "33") are reflected on the LJ chart, identification information corresponding to "(×) Warning" is added to the measurement results. In addition, when the measurement results within the range specified by "Lower Limit Value 1" and "Lower Limit Value 2" ("27" to "28") are reflected on the LJ chart, identification information corresponding to "(×) Warning" is added to the measurement results.
[0098] As shown in Figure 5(B), the XbarM graph is created by calculating the average value of the measurement results of a certain number (e.g., 20 samples) of test subjects received from the blood cell counting device 3, and plotting the average value using a time series. The "target value" (e.g., "8.07") in the XbarM graph is a value determined by statistically analyzing past test results of test subjects. The "target value" is provided by the service provider. The "target value" can also be a user-defined value. The "upper limit 1" and "lower limit 1" in the XbarM graph are the upper and lower limits provided by the service provider, respectively. The "upper limit 1" and "lower limit 1" can also be user-defined values. The "target value," "upper limit 1," and "lower limit 1" can vary for each blood cell counting device 3. The "upper limit 2" and "lower limit 2" in the XbarM graph are, for example, values set corresponding to the respective values of "upper limit 1" and "lower limit 1." The "upper limit 2" and "lower limit 2" can also be user-defined values. Furthermore, the limit values in the XbarM diagram can be omitted.
[0099] In Figure 5(A), if the mouse cursor C1 is displayed on the LJ chart, line L1 is displayed so that it passes through the QC measurement point MP1 closest to the mouse cursor C1. Alternatively, for example, an area corresponding to a day (24 hours) including the QC measurement point MP1 can be displayed instead of line L1. The user places the mouse cursor C1 (or a stylus, the user's finger, etc. if the LJ chart is displayed on a touchscreen) on line L1 and moves line L1 left or right to change the display position of line L1. Furthermore, for a day including line L1 (a portion of the first management chart) on the LJ chart shown in Figure 5(A) (January 3, 2020 in the example of Figure 5(A)), a specific area A1 is displayed on the XbarM chart shown in Figure 5(B). Moreover, moving line L1 on the LJ chart left or right also moves the specific area A1 on the XbarM chart (third management chart) left or right accordingly. That is, the display method of the XbarM chart changes accordingly to the change of line L1 on the LJ chart.
[0100] ( Figure 4 Step S10)
[0101] Back Figure 4 The responsible terminal 5 determines whether the responsible person has accepted the display instruction for a certain period (e.g., 1 day) (second period) on the XbarM or LJ chart through the designated device. If the instruction has been accepted (yes in step S10), the process proceeds to step S11; if the instruction has not been accepted (no in step S10), the process proceeds to step S16.
[0102] (Step S11)
[0103] The person in charge terminal 5 transmits the display data production instruction corresponding to the accepted display instruction to the accuracy management auxiliary device 1.
[0104] (Step S12)
[0105] The accuracy management auxiliary device 1 determines whether it has received a display data production instruction corresponding to the display instruction accepted by the responsible terminal 5. If the instruction has been accepted (yes in step S12), the process proceeds to step S13; if the instruction has not been accepted (no in step S12), the process proceeds to step S18.
[0106] (Step S13)
[0107] The precision management auxiliary device 1 generates and transmits display data to the responsible terminal 5. The display data is used to display the XbarM chart (second management chart) of the above-mentioned 1 day corresponding to the accepted instruction.
[0108] (Step S14)
[0109] The responsible terminal 5 determines whether it has received display data for displaying the XbarM chart (second management chart) from the accuracy management auxiliary device 1. If display data has been received (yes in step S14), the process proceeds to step S15; if display data has not been received (no in step S14), the responsible terminal 5 remains in standby mode until it receives data.
[0110] (Step S15)
[0111] The terminal 5 in charge displays the XbarM diagram (second management diagram) based on the accepted data.
[0112] (Step S16)
[0113] The responsible person terminal 5 determines whether the displayed end instruction has been accepted by the aforementioned responsible person. If the instruction has been accepted (yes in step S16), the process proceeds to step S17; if the instruction has not been accepted (no in step S16), the process returns to step S1.
[0114] (Step S17)
[0115] The responsible terminal 5 will display an end instruction and transmit it to the accuracy management auxiliary device 1 to terminate the process.
[0116] (Step S18)
[0117] The accuracy management auxiliary device 1 determines whether it has received the displayed end instruction from the responsible person's terminal 5. If the end instruction has been received (yes in step S18), the process ends; if the end instruction has not been received (no in step S18), the process returns to step S4.
[0118] (Example 1)
[0119] Figure 6(A) is an example of an LJ chart and an XbarM chart. Figure 6(B) is an example of an XbarM chart. In the example of Figure 6(A), the LJ chart (first management chart) for the display period from December 27, 2019 to January 5, 2020 (first period) and the XbarM chart (third management chart) for the display period from December 27, 2019 to January 5, 2020 (third period) are displayed on the monitor of the responsible terminal 5. If line L2 on the LJ chart shown in Figure 6(A) is specified (specifying a part of the first management chart), a specific area A3 (a part of the third management chart) on the XbarM chart corresponding to the day (January 3, 2020) including line L2 will be displayed in a different way than other areas. On the XbarM chart, the specific area A3 can be displayed in a different color than other areas, or only the specific area A3 can be highlighted. Here, if the person in charge operates cursor C3 to select the specific area A3 corresponding to January 3, 2020 (specifying a part of the third management chart), the XbarM chart (second management chart) shown in Figure 6(B) will be displayed. The XbarM chart (second management chart) shown in Figure 6(B) represents the results obtained by measuring the sample of the test subject using the blood cell counting device 3 during the corresponding period (second period) of January 3, 2020, which is shorter than the period corresponding to December 27, 2019 to January 5, 2020 (third period). According to this technical solution, the LJ chart (first management chart) and XbarM chart (second management chart) are displayed according to the difference between the measurement frequency of the precision management substance and the measurement frequency of the test subject sample. Therefore, the cause can be easily determined when the measurement results are abnormal.
[0120] For example, in the XbarM chart (third management chart) shown in Figure 6(A), it is difficult to grasp the changes in the test results of the subject samples on January 3, 2020 due to the short interval between the test results. However, in the XbarM chart (second management chart) of the second period shown in Figure 6(B), it is easy to grasp the changes in the test results of the subject samples within one day.
[0121] Furthermore, according to this technical solution, an XbarM chart (second management chart) can be displayed for any day desired by the viewer. Therefore, the measurement results on the day the anomaly occurred can be confirmed, and the cause of the anomaly can be more easily determined.
[0122] Furthermore, according to this technical solution, the LJ chart (first management chart) is displayed during the acceptance period, and the LJ chart (first management chart) within the acceptance period is also displayed, making it easy to trace back to understand the changes in the measurement results of QC samples. Therefore, it is easier to determine the cause of anomalies.
[0123] Furthermore, according to this technical solution, the display period of the XbarM diagram (second management diagram) shown in Figure 6(B) is specified while the LJ diagram (first management diagram) is already displayed on the screen. Therefore, the occurrence period of the cause of the anomaly can be estimated based on the LJ diagram (first management diagram), and the changes in the estimated occurrence period can be confirmed in more detail based on the XbarM diagram (second management diagram) shown in Figure 6(B). Thus, it is easier to determine the cause of the anomaly.
[0124] Furthermore, according to this technical solution, the XbarM chart (third management chart) shown in Figure 6(A) is displayed on the monitor, and the designation of a specific area A3 of the XbarM chart (third management chart) shown in Figure 6(A) is accepted, thereby displaying the XbarM chart (second management chart) shown in Figure 6(B). Therefore, it is possible to confirm both medium- and long-term variations and short-term variations in the measurement results of the tested sample, and it is easier to estimate the timing of the occurrence of the abnormality. Thus, it is easier to determine the cause of the abnormality.
[0125] Furthermore, according to this technical solution, in the XbarM chart (third management chart) shown in Figure 6(A), a specific region A3 is displayed in a different form than other periods. This specific region A3 represents the period corresponding to line L2 displayed on the LJ chart (first management chart) shown in Figure 6(A). Therefore, it is easy to identify the period in which the test sample's measurement results are abnormal. Thus, it is easier to estimate the period in which the cause of the abnormality occurred. In addition, the specific region A3 moves with the line L2, making it easy to specify the display period of the XbarM chart (second management chart) shown in Figure 6(B).
[0126] (Example 2)
[0127] Figure 7 This is a schematic diagram of an example of an XbarM diagram according to one embodiment. Figure 7 The indicator interface SD5 shown is a representation Figure 7 The XbarM chart (second management chart) with a display period of 1 day (January 3, 2020 in this example) shown in Figure 6(A) corresponds to which display period is between December 27, 2019 and January 5, 2020, in the XbarM chart (third management chart) shown in Figure 6(A)? That is, the indicator interface SD5 is... Figure 7 The XbarM diagram shown in Figure 6(A) displays the relationship between the display period (second period: January 3, 2020 in this example) and the display period of the XbarM diagram shown in Figure 6(A) (third period: December 27, 2019 to January 5, 2020 in this example).
[0128] Additionally, the display of the responsible terminal 5, which shows the indicator interface SD5, is used for processing. Figure 7 If the display period of the XbarM diagram is changed (by moving the indicator I1 left or right to change the position of a specific area A7), the display period of the XbarM diagram will change accordingly.
[0129] Based on this technical solution, it is easy to grasp the display period of the XbarM chart (third management chart) shown in Figure 6(A) and Figure 7 The XbarM chart (second management chart) shown illustrates the relationship between periods, thus enabling the identification of both medium- to long-term and short-term variations in the measurement results of the tested sample, and making it easier to estimate the timing of the abnormality.
[0130] Furthermore, based on this technical solution, it is possible to change Figure 7 The XbarM chart (second management chart) shown indicates the period during which short-term variations in measurement results can be identified over several periods, and it is easier to estimate the timing of the occurrence of the cause of the anomaly.
[0131] (Example 3)
[0132] Figure 8(A) is an example of an LJ chart and an XbarM chart. Figure 8(B) is an example of an XbarM chart (second management chart) displayed when certain operations are performed on the XbarM chart in Figure 8(A). Figure 8(C) is an example of an XbarM chart (second management chart) displayed when certain operations are performed on the XbarM chart in Figure 8(B). In the example of Figure 8(A), the LJ chart (first management chart) for the display period from December 27, 2019 to January 5, 2020 (first period) and the XbarM chart (third management chart) for the display period from December 27, 2019 to January 5, 2020 (third period) are displayed on the monitor of the responsible terminal 5. If line L3 on the LJ chart shown in Figure 8(A) is specified, the specific area A9 on the XbarM chart corresponding to the day (January 5, 2020) including line L3 will be displayed in a different way than other areas. Specific region A9 is the area divided on the XbarM chart by lines L5 and L7. Here, if the person in charge operates cursor C2 and moves line L7 on the XbarM chart to the position corresponding to line L9 on January 2, 2020, a new specific region A11 will be formed on the XbarM chart, divided by lines L9 and L5. If the person in charge selects specific region A11 (specifying a part of the third management chart), the XbarM chart (second management chart) shown in Figure 8(B) will be displayed. The XbarM chart (second management chart) shown in Figure 8(B) represents the results obtained by measuring the test subject samples using the blood cell counting device 3 during the period corresponding to January 2, 2020 to January 5, 2020. Furthermore, if the person in charge selects the specific area A13 corresponding to January 3, 2020 on the XbarM chart shown in Figure 8(B), the XbarM chart (second management chart) shown in Figure 8(C) will be displayed. The XbarM chart (second management chart) shown in Figure 8(C) represents the results obtained by measuring the sample of the tested subject using the blood cell counting device 3 during the period corresponding to January 3, 2020.
[0133] (Example 4)
[0134] Figure 9 and Figure 10 This is an example schematic diagram of the LJ diagram and XbarM diagram involved in one embodiment. Figure 9 This is an example schematic diagram of the LJ plot and XbarM plot when calibration was performed during the display period. Figure 10 This is another example of LJ and XbarM diagrams in the case where reagents are replaced in the blood cell counting device 3 during the display period. Figure 11 This is an example of an illustration of the LJ graph and XbarM graph in the event that an error occurs in the blood cell counting device 3 during display. Figures 9-11 As shown, in the LJ and XbarM graphs, markers are displayed when certain events occur during the display period, indicating the occurrence of these events. These events include at least one of the following: an error occurring in the blood cell counting device 3; calibration being performed in the blood cell counting device 3; or reagent replacement in the blood cell counting device 3. The probability of abnormal measurement results is higher before and after such events than at other times; therefore, by displaying markers indicating the occurrence of these events, the timing of the abnormality can be easily predicted. Furthermore, markers indicating the occurrence of certain events can also be displayed on the XbarM graph (second management graph), which has a shorter display period than the LJ graph, as shown in Figure 6(B).
[0135] like Figure 9 As shown, if calibration of the blood cell counting device 3 was performed during the display period, a mark is displayed at the position corresponding to the date and time of the calibration (January 3, 2020). (Black circle) S1. The implementation date and time (January 3, 2020) correspond to a specific region A15 on the LJ chart and a specific region A17 on the XbarM chart. Calibration was performed to confirm that the blood cell counting device 3 output the most appropriate measurement results.
[0136] like Figure 10 As shown, if the reagents for the blood cell counting device 3 were replaced during the display period, a mark is displayed at the location corresponding to the date and time of that replacement (January 3, 2020). (Black triangle) S3. The implementation date and time (January 3, 2020) corresponds to a specific area A15 on the LJ chart and a specific area A17 on the XbarM chart.
[0137] like Figure 11 As shown, if an error occurs in the blood cell counting device 3 during the display period, a mark will be displayed at the position corresponding to the date and time of the error (January 3, 2020). S5. Select a marker on the display of the responsible terminal 5. In this case, image G can be displayed on the monitor, where image G represents the relevant records of an error occurrence (a certain event). According to this technical solution, the relevant records of an error occurrence can be easily grasped on an LJ chart or XbarM chart. This is based on the dataset shown in Figure 3. Figure 9 , Figure 10 and Figure 11 The symbols shown indicate the occurrence of certain events. Information on calibration implementation, reagent replacement, and error occurrence is contained in the dataset along with their corresponding dates, and a symbol indicating the occurrence of a certain event is displayed at the location corresponding to the date and time of occurrence.
[0138] (QC diagram showing a variation of the processing example 1)
[0139] In the examples of Figures 6(A) and 8(A), both the LJ diagram and the XbarM diagram are shown. However, in the variant 1 of the QC diagram display processing, the accuracy management auxiliary device 1 first displays the LJ diagram and then displays the XbarM diagram in accordance with the operation of the person in charge.
[0140] Figure 12 This is another schematic diagram illustrating the display processing of the LJ diagram and XbarM diagram involved in one embodiment. For example... Figure 12 As shown, first in Figure 1 The monitor of the responsible terminal 5 shows the LJ diagram (first management diagram). If the line L11 (a part of the first management diagram) corresponding to the measurement date (January 3, 2020) on the LJ diagram is specified, the XbarM diagram (second management diagram) with January 3, 2020, corresponding to the specified line L11 as the display period (second period) will be displayed on the monitor of the responsible terminal 5.
[0141] According to this technical solution, by specifying line L11 corresponding to the measurement date (January 3, 2020) on the LJ chart, an XbarM chart is displayed with the period corresponding to line L11 as the display period (second period). Therefore, changes in the measurement results of the tested object within a short period can be identified with less effort. Thus, the cause of the anomaly can be determined more quickly.
[0142] (Example 1 of the display processing for a specified area)
[0143] The following describes a variation of the display processing of line L1 in Figure 5(A), line L2 in Figure 6(A), and line L3 in Figure 8(A) (hereinafter referred to as the designated area). First, we will describe an example in Variation 1 where the designated area is positioned at the measurement time point or the occurrence time of a certain event. In Variation 1, the designated area is displayed in the following priority order (1) to (4).
[0144] (1) When the blood cell counting device 3 produces an error or a warning (Warning) as part of the QC measurement, a designated area is displayed at the time (point) of occurrence. If there are multiple points, the designated area is displayed at the point where the deviation from the target value is the largest.
[0145] (2) When there is a calibration result of the blood cell counting device 3, the specified area is displayed at that point.
[0146] (3) When the reagent of the blood cell counting device 3 is replaced, the designated area is displayed at that point.
[0147] (4) If it does not meet (1)~(3), the specified area will be displayed on the latest data chart on the LJ chart.
[0148] (Example 2 of display processing for a specified area)
[0149] Figure 13 This is another schematic diagram illustrating a display method of the LJ diagram according to one embodiment. The designated area may not be displayed as a line shape like line L1 in Figure 5(A), line L2 in Figure 6(A), and line L3 in Figure 8(A), but rather as... Figure 13 As shown, a designated area A19 with a certain polygonal shape (such as a quadrilateral shape) is displayed on the LJ diagram.
[0150] (Example 3 of the display processing for a specified area)
[0151] In variation 3, the precision management auxiliary device 1 performs the assignment of regions on the LJ diagram on the region assignment interface.
[0152] Figure 14(A) is an example schematic diagram of the designated area setting interface DS1. Figure 14(B) is an example schematic diagram of an LJ chart displayed with the period corresponding to the period specified in the designated area setting interface DS1 as the designated area. In the designated area setting interface DS1 shown in Figure 14(A), the display period of the designated area on the designated LJ chart is from December 30, 2019 to December 31, 2019. In this case, as shown in Figure 14(B), the LJ chart is displayed including the designated area A21, which starts from December 30, 2019 and ends on December 31, 2019.
[0153] (Example 4 of the display processing for a specified area)
[0154] In this variation 4, the precision management auxiliary device 1 controls the display size or display position of a specified area on the LJ diagram.
[0155] Figure 15(A) is a schematic diagram of an example of size control for a specified area in an LJ diagram. Figure 15(B) is a schematic diagram of an example of position control for a specified area in an LJ diagram. As shown in Figure 15(A), the display size of a specified area on the LJ diagram can be controlled. The person in charge performs multi-touch screen operations on the display of the person in charge terminal 5 displaying the LJ diagram. For example, after specifying area A23 on the display, the person in charge can zoom in (expand outward) or zoom out (shrink inward) the specified area A23 by using two fingers, thereby controlling the display size of the specified area A23. The control of the display size of the specified area A23 can be performed in any direction, either horizontally or vertically. As shown in Figure 15(B), the display position of a specified area on the LJ diagram can be controlled. After specifying the specified area A23 by operating the cursor C9, the person in charge can move the specified area A23 in the left and right directions. When the display has a touch screen function, the person in charge can move the specified area A23 in the left and right directions through touch operation.
[0156] (Example 1 of the specified processing during the display period)
[0157] In this variation 1, the display period of the LJ chart can be specified differently from the display period of the XbarM chart. In this respect, the display period of the LJ chart is automatically set to be the same as the display period of the XbarM chart. Figure 4 The way it is illustrated in Figure 5 is different.
[0158] Figure 16 This is an example schematic diagram of a display period specifying interface, LJ image, and XbarM image according to one embodiment. First, the display period specifying interface DS3 for the XbarM image specifies the display period as December 27, 2019 to January 5, 2020. Additionally, the display period specifying interface DS5 for the LJ image separately specifies the display period as December 27, 2019 to January 5, 2020. Thus, the LJ image and XbarM image are displayed during their respective display periods specified by the display period specifying interfaces DS3 and DS5.
[0159] (Example 2 of the specified processing during the display period)
[0160] In this variation 2, the display period of the XbarM graph is set to be shorter than that of the LJ graph, which is different from variation 1.
[0161] Figure 17 This is an example schematic diagram of a display period specification interface, LJ image, and XbarM image according to one embodiment, illustrating a case where the display period of the XbarM image is set to be shorter than that of the LJ image. Figure 17As shown, the display period for the XbarM chart is specified on interface DS9 (January 3, 2020), which is shorter than the period specified on interface DS7 (December 27, 2019 to January 5, 2020) for the LJ chart. In this case, the LJ chart displayed during the period corresponding to December 27, 2019 to January 5, 2020, and the XbarM chart displayed during the separately specified period (January 3, 2020) are arranged together.
[0162] According to this technical solution, for example, when the period of an anomaly has been deduced from errors in the measurement operation, the display period of the XbarM graph can be specified on the DS9 interface, thus allowing for the quick confirmation of changes in the measurement results of the tested object within a short period. Therefore, the cause of the anomaly can be determined more rapidly.
[0163] In addition, the display period of the XbarM chart and the display period of the LJ chart should at least partially overlap. For example, you can specify December 27, 2019 to January 5, 2020 as the display period of the LJ chart, and specify December 26, 2019 to December 28, 2019 as the display period of the XbarM chart.
[0164] (Example 3 of the specified processing during the display period)
[0165] In this variation 3, if a specific area is specified in the XbarM diagram displayed for a certain display period, the display will switch to the XbarM diagram for the display period corresponding to that specific area.
[0166] Figure 18 The XbarM chart at the top displays the XbarM chart for the period from December 27, 2019 to January 5, 2020. For example, you can use cursor C11 to specify the specific area A25 on the XbarM chart corresponding to January 3, 2020. In this case, the display switches out... Figure 18 The XbarM plot on the lower side. Figure 18 The XbarM chart below is an XbarM chart that displays data from January 3, 2020, corresponding to a specific area A25.
[0167] (Example 4 of the specified processing during the display period)
[0168] In this variation 4, even if the display period is not specified, the XbarM chart will be automatically displayed with a certain period of the LJ chart's display period (such as the last day of the LJ chart's display period).
[0169] Figure 19(A) is an example of an LJ chart displayed with a specified display period. Figure 19(B) is an example of an XbarM chart displayed with the last day of the display period of the LJ chart in Figure 19(A). As shown in Figure 19(A), the last day of the LJ chart displayed with the display period of December 27, 2019 to January 5, 2020 is January 5, 2020. As shown in Figure 19(B), in this case, an XbarM chart with January 5, 2020, corresponding to the last day of the LJ chart, will be automatically displayed.
[0170] According to the first embodiment, the accuracy management assistance system 100 displays a first management chart (LJ chart) on the display during a first period, and a second management chart (XbarM chart) on the display during a second period shorter than the first period. Therefore, in the above-described accuracy management assistance method, the first and second management charts are displayed for a display period corresponding to the difference between the measurement frequency of the accuracy management substance and the measurement frequency of the test sample. Therefore, when an anomaly is found in the measurement results, the cause can be easily determined.
[0171] [Second Implementation]
[0172] The second embodiment determines the target and limit values of the LJ chart through external precision management, which differs from the first embodiment, which uses target and limit values determined for each batch based on the QC samples. Hereinafter, the differences between the second and first embodiments will be specifically explained.
[0173] Figure 20 This is a schematic diagram of an example of the LJ diagram involved in the second embodiment. For example... Figure 20 As shown in the LJ diagram, the "target value" (e.g., "30") is a standard value determined by statistically analyzing the QC measurement results of each facility. The "upper limit value 3" (e.g., "40") and "lower limit value 3" (e.g., "20") are the upper and lower limits determined by statistically analyzing the QC measurement results of each facility. The "upper limit value 4" (e.g., "37") and "lower limit value 4" (e.g., "23") are values set corresponding to the respective values of "upper limit value 3" and "lower limit value 3". Each upper and lower limit value can be set by the user.
[0174] Figure 21 This is an example flowchart of the QC chart display process according to the second embodiment. Figure 21 In the processing steps S21 to S39, except for step S25, all are related to Figure 4 The processing steps S1 to S18 shown correspond to each other. Figure 21In step S25 shown, the precision management auxiliary device 1 statistically displays the QC measurement results of each facility during the period and decides... Figure 20 The target values and limit values are shown.
[0175] According to the second embodiment, the precision management assistance system 100 can not only achieve the effects described in the first embodiment, but also realize external precision management within a management group with several facilities by managing each facility through the same management entity.
[0176] [Third Implementation Method]
[0177] The third embodiment combines the functions of the accuracy management auxiliary device 1 and the responsible person terminal 5 of the first embodiment into the accuracy management auxiliary device 1, which differs from the first embodiment. Hereinafter, the differences between the third embodiment and the first embodiment will be specifically described.
[0178] like Figure 22 As shown, the accuracy management auxiliary device 1 is connected to the blood cell counting device 3A via a network NA. The hardware structure of the accuracy management auxiliary device 1 is similar to... Figure 2 The structures shown are the same.
[0179] Figure 23 This is a flowchart of an example of the QC diagram display processing according to the third embodiment.
[0180] (Step S41)
[0181] The accuracy management auxiliary device 1 determines whether the person in charge has accepted the relevant designation for displaying QC charts (e.g., LJ charts and XbarM charts) on the accuracy management auxiliary device 1. If the designation has been accepted ("Yes" in step S41), the process proceeds to step S42; if the designation has not been accepted ("No" in step S41), the process proceeds to step S47.
[0182] (Step S42)
[0183] The accuracy management auxiliary device 1 determines whether the person in charge has accepted the display instructions for the LJ diagram and XbarM diagram. If the instruction has been accepted ("Yes" in step S42), the process proceeds to step S43; if the instruction has not been accepted ("No" in step S42), the device remains in standby mode until an instruction is accepted.
[0184] (Step S43)
[0185] Precision Management Auxiliary Device 1 Figure 2 The storage device 13 shown reads the measurement data of the pre-stored blood cell counting device 3.
[0186] (Step S44)
[0187] Precision management auxiliary device 1 determines QC measurement results that are outside the allowable range.
[0188] (Step S45)
[0189] The precision management auxiliary device 1 generates display data, which is used to display the LJ graph and XbarM graph on the display screen of the precision management auxiliary device 1.
[0190] (Step S46)
[0191] The accuracy management auxiliary device 1 displays the LJ graph and XbarM graph on the display during the display period specified in step S41 (the period corresponding to December 27, 2019 to January 5, 2020) based on the generated display data.
[0192] (Step S47)
[0193] The accuracy management auxiliary device 1 determines whether the person in charge has accepted the display instruction for a certain period (e.g., 1 day) (second period) on the XbarM chart or LJ chart through the fixed-point equipment. If the instruction has been accepted (yes in step S47), the process proceeds to step S48; if the instruction has not been accepted (no in step S47), the process proceeds to step S50.
[0194] (Step S48)
[0195] The accuracy management auxiliary device 1 generates display data, which is used to display the XbarM chart (second management chart) of the above-mentioned 1 day corresponding to the received instruction.
[0196] (Step S49)
[0197] The accuracy management auxiliary device 1 displays an XbarM chart (second management chart) based on the generated display data.
[0198] (Step S50)
[0199] The accuracy management auxiliary device 1 determines whether the displayed end instruction has been accepted by the aforementioned person in charge. If the instruction has been accepted ("Yes" in step S50), the process ends; if the instruction has not been accepted ("No" in step S50), the process returns to step S41. Therefore, according to the third embodiment, it is not necessary to prepare a person in charge terminal separately from the accuracy management auxiliary device 1.
[0200] [Other Implementation Methods]
[0201] The above embodiments are explanations provided for ease of understanding of the present invention and are not intended to limit the present invention. Modifications / improvements can be made to the present invention without departing from its spirit (such as combining embodiments or omitting parts of the technical solutions in each embodiment), and the present invention also includes equivalent examples.
[0202] In the above embodiments, a blood cell counting device 3 was described as an example of an analytical device, but it is not limited to this. Other analytical devices may be used, such as a blood coagulation assay device, a biochemical analysis device, an immunoassay device, a urine analysis device, or a nucleic acid analysis device.
[0203] Figure 24 This is another schematic diagram illustrating the structure of a precision management assistance system according to one embodiment. Figure 1 In the example, the precision management auxiliary device 1 is configured within a support center, which differs from a facility equipped with a responsible person's terminal, but as... Figure 24 As shown, a precision management auxiliary device 1 can be configured in a facility equipped with a responsible person's terminal.
[0204] Numbering Explanation
[0205] 1: Precision management auxiliary device; 3A, 3B: Blood cell counting device (analysis device); 5A, 5B: Person in charge terminal; 11: Processor (control unit); 12: Memory; 13: Storage device; 14: Communication device; 15: Input device; 16: Output device; 100: Precision management auxiliary system.
Claims
1. A precision management assistance method, which displays a management chart of precision management related to an analytical device for measuring a sample of a test object, the precision management assistance method being characterized by comprising: A first management chart is generated, which represents the results obtained by measuring the precision-managed substance using the analytical device during a first period; The designation of a second period that is different from the first period, the second period being shorter than the first period and overlapping with the first period in at least a portion; A second management chart is generated, which represents the results obtained by measuring the test sample through the analytical device during the second period; Display the generated first management diagram; Display the generated second management diagram; In the first management diagram, if a certain event occurs during the first period, a marker indicating the occurrence of the event is displayed. After selecting the marker, the relevant records of the certain event will be displayed.
2. The accuracy management auxiliary method according to claim 1, characterized in that... Also includes: The designation for the first period is accepted. Specifically, in the generation of the first management diagram, the first management diagram for the first period corresponding to the designated acceptance is generated.
3. The accuracy management auxiliary method according to claim 1, characterized in that: The designated processing during the second period is executed after the first management diagram is displayed.
4. The accuracy management auxiliary method according to claim 1, characterized in that: During the designated acceptance of the second period, the designation of the second period is accepted while the first management diagram is displayed.
5. The accuracy management auxiliary method according to claim 1, characterized in that... Also includes: A third management chart is generated, which represents the results obtained by measuring the test sample through the analysis device during a third period that is longer than the second period; as well as The generated third management diagram is displayed. Specifically, in the designated acceptance during the second period, the designation of the second period corresponding to the designated portion of the third management diagram is accepted by designating a portion of the displayed area.
6. The accuracy management auxiliary method according to claim 5, characterized in that... Also includes: A portion of the first management map is displayed in a form different from other areas; as well as The third management chart displays the period corresponding to the portion of the area on the first management chart in a different form than the other periods.
7. The accuracy management auxiliary method according to claim 6, characterized in that... Also includes: Modify the specified portion of the area in the first management map; The display format of the third management diagram is changed accordingly to the change in a portion of the first management diagram.
8. The accuracy management auxiliary method according to any one of claims 5 to 7, characterized in that... Also includes: Accept changes to a portion of the area described in the third management map.
9. The accuracy management auxiliary method according to any one of claims 5 to 7, characterized in that... Also includes: The second management diagram displays a relationship interface showing the relationship between the second period and the third period.
10. The accuracy management auxiliary method according to claim 9, characterized in that... Also includes: Changes to the display period of the second management diagram are handled through the aforementioned relationship interface; The second management diagram is displayed accordingly for the accepted changes.
11. The accuracy management auxiliary method according to any one of claims 1 to 4, characterized in that: In the designated acceptance during the second period, the designation of the second period corresponding to the designated portion of the first management map is accepted by designating a portion of the first management map.
12. The accuracy management auxiliary method according to any one of claims 1 to 4, characterized in that: In the designated acceptance of the second period, a dialog box for specifying the second period is displayed, and the designation of the second period is accepted through the dialog box.
13. The accuracy management auxiliary method according to claim 1, characterized in that: The specified event includes at least one of the following: an error occurring in the analytical device, the calibration of the analytical device being performed, or the reagent replacement of the analytical device.
14. The accuracy management auxiliary method according to any one of claims 1 to 7, characterized in that: The first management chart and the second management chart are displayed in an arranged manner.
15. The accuracy management auxiliary method according to any one of claims 1 to 7, characterized in that: If the second management diagram is displayed, the display of the first management diagram will end.
16. The accuracy management auxiliary method according to any one of claims 1 to 7, characterized in that: The generation of the first management map and the generation of the second management map are performed by the precision management auxiliary device; The display of the first management diagram and the display of the second management diagram are performed by a terminal device connected to the accuracy management assistance device via a network.
17. The accuracy management auxiliary method according to any one of claims 1 to 7, characterized in that: The precision management auxiliary device performs the generation and display of the first management map, the generation and display of the second management map.
18. A precision management assistance system, which applies the precision management assistance method as described in any one of claims 1 to 17, displays a management chart of precision management related to the analytical device for measuring a sample of a test object, the precision management assistance system being characterized by comprising: A precision management auxiliary device, which includes a first control unit; as well as The terminal device, connected to the accuracy management auxiliary device via a network, includes a second control unit and a display. The first control unit of the precision management auxiliary device performs the following: A first management chart is generated, which represents the results obtained by measuring the precision-managed substance using the analytical device during a first period; The designation of a second period, which is different from the first period, is accepted. The second period is shorter than the first period and overlaps with the first period in at least part. A second management chart is generated, which represents the results obtained by measuring the test sample through the analytical device during the second period. The second control unit of the terminal device executes: The generated first management diagram is displayed on the monitor; The generated second management diagram is displayed on the monitor; In the first management diagram, if a certain event occurs during the first period, a marker indicating the occurrence of the event is displayed. After selecting the marker, the relevant records of the certain event will be displayed.
19. A storage medium containing an executable program that causes a precision management assistance device to perform the precision management assistance method as described in any one of claims 1 to 17, wherein, The accuracy management auxiliary device displays a management diagram related to the accuracy management of the analytical device used to measure the sample of the test object on a display of a terminal device connected via a network: A first management chart is generated, which represents the results obtained by measuring the precision-managed substance using the analytical device during a first period; The designation of a second period, which is different from the first period, is accepted. The second period is shorter than the first period and overlaps with the first period in at least part. A second management chart is generated, which represents the results obtained by measuring the test sample through the analytical device during the second period; The generated first management diagram is transmitted to the terminal device; The generated second management diagram is transmitted to the terminal device; In the first management diagram, if a certain event occurs during the first period, a marker indicating the occurrence of the event is displayed. After selecting the marker, the relevant records of the certain event will be displayed.
Citation Information
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