Method for applying control reference values ​​to a sample analyzer, sample analyzer, and computer program

Abstract

To cause a control reference value to be more efficiently determined and applied to a specimen analyzer in a test facility.SOLUTION: A method for applying a control reference value to a specimen analyzer applies, by a computer, a control reference value of a quality control sample to the specimen analyzer. The method comprises: generating the control reference value based on a measurement result of the quality control sample measured by the specimen analyzer and applying the control reference value to the specimen analyzer.SELECTED DRAWING: Figure 4B

Description

Technical Field

[0001] The present invention relates to a method for applying management reference values to a specimen analysis device, a specimen analysis device, and a computer program.

Background Art

[0002] Conventionally, internal accuracy management using accuracy control samples has been carried out in inspection facilities. In internal accuracy management, for example, as described in Non-Patent Document 1, it is recommended that the inspection facility individually determine the target value and tolerance range of the accuracy control sample. Therefore, when the person in charge of the inspection facility receives the accuracy control sample from the manufacturer, the accuracy control sample is measured a plurality of times by the specimen analysis device to be subjected to accuracy management, and the obtained plurality of measurement results are input into a computer. Using commercially available spreadsheet software, management reference values such as the target value and tolerance range (tolerance) of the accuracy control sample are calculated, and the obtained management reference values are input into the specimen analysis device to be subjected to accuracy management.

Prior Art Documents

Non-Patent Documents

[0003]

Non-Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0004] However, when management reference values such as the target value and tolerance range are individually determined in an inspection facility and input into a specimen analysis device, there is a problem that it takes a great deal of time and effort for the person in charge. Therefore, it is desired to streamline the determination of management reference values in inspection facilities and their application to specimen analysis devices.

[0005] The present invention aims to streamline the determination of control standards in testing facilities and their application to sample analyzers. [Means for solving the problem]

[0006] The present invention is a method for applying a control reference value for a quality control sample to a sample analyzer using a computer, comprising generating the control reference value based on the measurement result of the quality control sample measured by the sample analyzer, and applying the control reference value to the sample analyzer.

[0007] According to the method of the present invention, tasks such as inputting measurement results of quality control samples into a computer and inputting the obtained control reference values ​​into a sample analyzer by personnel at the testing facility are eliminated, thereby streamlining the determination of control reference values ​​and their application to the sample analyzer at the testing facility.

[0008] The specimen analyzer of the present invention is a specimen analyzer to which a control reference value for a quality control sample is applied, comprising a measuring device and a computer connected to the measuring device, wherein the computer generates the control reference value based on the measurement result of the quality control sample measured by the measuring device and applies the control reference value to the specimen analyzer.

[0009] According to the specimen analyzer of the present invention, tasks such as inputting measurement results of quality control samples into a computer and inputting the obtained control reference values ​​into the specimen analyzer by personnel at the testing facility are eliminated, thereby streamlining the determination of control reference values ​​and their application to the specimen analyzer at the testing facility.

[0010] The computer program of the present invention causes a computer that applies control reference values ​​for quality control samples to a sample analyzer to generate the control reference values ​​based on the measurement results of the quality control samples measured by the sample analyzer, and to apply the control reference values ​​to the sample analyzer.

[0011] According to the computer program of the present invention, by executing the program, tasks such as inputting measurement results of quality control samples into the computer and inputting the obtained control reference values ​​into the sample analyzer by the person in charge at the testing facility become unnecessary, and the determination of control reference values ​​and their application to the sample analyzer at the testing facility can be made more efficient. [Effects of the Invention]

[0012] According to the present invention, it is possible to efficiently determine management standard values ​​according to the facility and apply them to sample analyzers. [Brief explanation of the drawing]

[0013] [Figure 1] This diagram shows the overall configuration of the sample analysis system. [Figure 2] This is a block diagram showing the configuration of the measuring device in a sample analyzer. [Figure 3] This is a block diagram of the computer configuration. [Figure 4A] This flowchart shows the processes performed when rules for generating management criteria are initially set, and / or when the set rules are modified. [Figure 4B] This flowchart shows the process of registering a QC file, generating control standards, and applying them to a sample analyzer when a lot of quality control samples is updated. [Figure 4C] This is a flowchart showing the measurement process for quality control samples. [Figure 5] This figure shows an example of a QC file stored in a memory device. [Figure 6] This is a flowchart of the subroutine S10 in Figure 4A. [Figure 7] This figure shows an example of the display screen used when selecting a reference analyzer and receiving the reference number for the old lot. [Figure 8] This figure shows an example of a screen displayed on the screen when the user selects a measurement item to be used for setting rules to generate control reference values. [Figure 9]It is a figure showing an example of a display screen when receiving generation rules for target values and limit values. [Figure 10] It is a figure showing a check box (option), the text displayed in the "Target" column of the table when the option is selected, and the generation rule for the target value. [Figure 11A] It is a figure showing a check box (option), the text displayed in the "Limit" column of the table when the check box is selected, and the generation rule for the limit value. [Figure 11B] It is a figure showing a check box (option), the text displayed in the "Limit" column of the table when the check box is selected, and the generation rule for the limit value. [Figure 12] It is a flowchart showing the subroutine of S21 in FIG. 4B. [Figure 13] It is a figure showing an example of a screen displayed on the display when receiving selection of measurement results. [Figure 14] It is a figure showing an example of a chart graph display mode of a reference value setting support image displayed on the display. [Figure 15] It is a figure showing an example of a % graph display mode of a reference value setting support image displayed on the display. [Figure 16] It is a figure showing an example of an internal accuracy management setting sheet displayed on the display. [Figure 17] It is a figure showing an example of an internal accuracy management setting sheet displayed on the display.

Embodiments for Carrying Out the Invention

[0014] Hereinafter, with reference to the drawings, embodiments of a method for applying management reference values to a specimen analysis apparatus, the specimen analysis apparatus, and a computer program according to the present invention will be described in detail.

[0015] Figure 1 shows the overall configuration of the specimen analysis system 1. The specimen analysis system 1 is installed in testing facilities such as hospitals and testing centers. As shown in Figure 1, the specimen analysis system 1 includes specimen analyzers 2a, 2b, and 2c. Specimen analyzer 2a includes a measuring device 3a and a computer 30a connected to the measuring device 3a. Specimen analyzer 2b, similar to specimen analyzer 2a, includes a measuring device 3b and a computer 30b connected to the measuring device 3b. Specimen analyzer 2c, similar to specimen analyzer 2a, includes a measuring device 3c and a computer 30c connected to the measuring device 3c. Computers 30a, 30b, and 30c are connected via LAN cables and can communicate with each other. Specimen analyzers 2a, 2b, and 2c are hemocytometers that count blood cells contained in blood samples. Since specimen analyzers 2a, 2b, and 2c have similar configurations, specimen analyzer 2a will be described below.

[0016] Internal quality control is performed on the sample analyzer 2a using quality control samples. A quality control sample is a sample prepared to contain a predetermined concentration of a predetermined component, and is manufactured by the quality control sample manufacturer. When a new batch of quality control samples from the manufacturer is delivered to the testing facility where the sample analysis system 1 is installed (the user of the sample analysis system 1), the person in charge of the facility measures the quality control sample one or more times, preferably multiple times, using the sample analyzer 2a. The computer 30a generates a control reference value for the quality control sample based on the measurement results and applies it to the sample analyzer 2a. The control reference value generated based on the measurement results of the quality control sample is a value indicating the target value (hereinafter also referred to as the target value) and / or acceptable range of the measurement results of the quality control sample. The target value is, for example, a statistical value such as the measurement result obtained by measuring the quality control sample once, or the average value, median, or other statistical value of multiple measurement results obtained by measuring the quality control sample multiple times. The values ​​indicating the acceptable range are, for example, the standard deviation of multiple measurement results or the value obtained by multiplying the standard deviation by a constant (hereinafter referred to as the limit value (#)), and / or the coefficient of variation of multiple measurement results or the value obtained by multiplying the coefficient of variation by a constant (hereinafter referred to as the limit value (%CV)). In the following explanation, the limit value (#) and / or the limit value (%CV) will also be referred to as the limit value. When calculating the limit value (%CV) from the measurement results of quality control samples from multiple manufacturing lots, the weighted average value of the coefficient of variation may be calculated based on the number of measurement days for the quality control samples of each manufacturing lot, and the calculated weighted average value may be used as the limit value (%CV). Prior to measuring the blood sample of the subject, the user measures the quality control sample using the sample analyzer 2a. The measurement results of the quality control sample by the sample analyzer 2a are output by the computer 30a. The user compares the measurement result with the control reference value applied to the sample analyzer 2a and determines whether or not a reportable measurement result can be output from the sample analyzer 2a.

[0017] Computer 30a has a computer program (reference value application program) installed for applying control reference values ​​to the sample analyzer 2a. The method for applying control reference values ​​to the sample analyzer, as executed by the reference value application program, will be explained in detail later.

[0018] Figure 2 is a block diagram showing the configuration of the measuring device 3a of the sample analyzer 2a. The measuring device 3a includes a control unit 4, a communication unit 5, and a measuring unit 6. The control unit 4, the communication unit 5, and the measuring unit 6 are each connected via a bus. The communication unit 5 has a communication interface for communicating with the computer 30a. The communication interface is, for example, an Ethernet® interface. The control unit 4 has an FPGA, memory, etc. The control unit 4 controls the operation of each part of the communication unit 5 and the measuring unit 6.

[0019] The measurement unit 6 prepares a measurement sample from a blood sample and detects blood cells and hemoglobin contained in the measurement sample. The measurement unit 6 includes a sample aspiration unit 7, a sample preparation unit 8, and a measurement unit 10. The sample aspiration unit 7 aspirates a blood sample from a sample container received by the sample analyzer 2a and supplies it to the sample preparation unit 8. The sample preparation unit 8 mixes the blood sample with reagents to prepare a first measurement sample for detecting red blood cells and platelets, a second measurement sample for detecting white blood cells, and a third measurement sample for detecting hemoglobin, and supplies them to the measurement unit 10.

[0020] The measurement unit 10 includes an electrical resistance detection unit 11, an optical detection unit 12, and a hemoglobin measurement unit 13. The electrical resistance detection unit 11 is equipped with a flow cell 11a and detects red blood cells and platelets contained in the first measurement sample flowing through the flow cell 11a together with the sheath fluid using the sheath flow DC detection method. The optical detection unit 12 is equipped with a flow cell 12a and detects white blood cells contained in the second measurement sample flowing through the flow cell 12a together with the sheath fluid using the flow cytometry method. The hemoglobin measurement unit 13 is equipped with a cell 13a and detects hemoglobin contained in the third measurement sample contained in the cell 13a using the SLS-hemoglobin method. Each detection unit 11, 12 and measurement unit 13 sends data representing the measured value of the corresponding sample to the control unit 4, and the control unit 4 outputs the data to the computer 30a via the communication unit 5. The above describes the case when measuring a blood sample, but the measurement unit 6 performs the same operation when measuring a quality control sample. As the measuring unit 6, for example, the apparatus described in U.S. Patent Publication No. 2016-0282377 is hereby incorporated herein by reference.

[0021] Figure 3 is a block diagram showing the configuration of computer 30a. Computer 30a includes a control unit 31, a storage device 35, an input / output interface 36, a readout device 37, a communication interface 38, an image output interface 39, and a display input unit 50. The control unit 31 includes a CPU 32, a ROM 33, and a RAM 34. The CPU 32, ROM 33, RAM 34, storage device 35, input / output interface 36, readout device 37, communication interface 38, and image output interface 39 are connected to each other by a bus for data communication. The display input unit 50 includes a display, a keyboard, and a mouse.

[0022] The CPU 32 is capable of executing computer programs stored in the ROM 33 and computer programs loaded into RAM. The ROM 33 consists of a mask ROM, PROM, EPROM, EEPROM, etc., and stores the computer programs to be executed by the CPU 32 and the data used for them.

[0023] RAM34 is composed of SRAM, DRAM, etc. RAM34 is used as a workspace for the CPU32 when executing computer programs stored in ROM33 and storage device35.

[0024] The storage device 35 is composed of a solid-state drive, a hard disk drive, etc., and stores various computer programs to be executed by the CPU 32, such as an operating system and application programs, as well as data used to execute said computer programs. The storage device 35 also stores a reference value application program and the data used to execute it. Furthermore, the storage device 35 stores the QC file (Figure 5), which will be described later.

[0025] The reading device 37 is composed of a flexible disk drive, CD-ROM drive, DVD-ROM drive, etc., and can read computer programs or data recorded on a portable recording medium.

[0026] The input / output interface 36 consists of interfaces such as USB and IEEE1394. An input device consisting of a keyboard and mouse, which constitute the display input unit 50, is connected to the input / output interface 36, and the user can input data to the control unit 31 by using this input device.

[0027] The communication interface 38 is, for example, an Ethernet® interface. The control unit 31 can send and receive data with the measuring device 3a and computers 30b and 30c connected via a network using a predetermined communication protocol through the communication interface 38.

[0028] The image output interface 39 is connected to the display of the display input unit 50 and outputs a video signal to the display according to the image data provided by the CPU 32. The display displays the image on the screen according to the input video signal.

[0029] The storage device 35 has an operating system installed that provides a graphical user interface environment, such as Windows®, manufactured and sold by Microsoft Corporation. The following describes the case where the reference value application program operates on this operating system.

[0030] The following describes in detail how the control unit 31 of the computer 30a applies control reference values ​​to the sample analyzers 2a, 2b, and 2c, as executed by the reference value application program. Figure 4A is a flowchart showing the process performed when the rules for generating control reference values ​​are initially set and / or when the set rules are changed. Figure 4B is a flowchart showing the process of registering the QC file, generating control reference values, and applying them to the sample analyzers 2a, 2b, and 2c when the lot of quality control samples is updated. Figure 4C is a flowchart showing the daily measurement process for quality control samples.

[0031] As shown in Figure 4A, the control unit 31 of the computer 30a accepts the setting of the rules for generating control reference values ​​when the rules for generating control reference values ​​are set for the first time and / or when the set rules are changed (S10). As rules for generating control reference values, any of the following can be set: (1) a first rule that generates control reference values ​​based on measurement results obtained by measuring a quality control sample, (2) a second rule that generates control reference values ​​based on a value specified by the user, and (3) a third rule that generates control reference values ​​based on a value specified by the manufacturer of the quality control sample. The rule setting subroutine will be described in detail later.

[0032] The process shown in Figure 4B is performed when a new lot of quality control samples arrives at the testing facility. The control unit 31 of computer 30a registers the information of the new lot in the QC file stored in the storage device 35 (S20). The control unit 31 of computer 30a reads the information of the new lot from the recording medium enclosed with the quality control sample, or from the computer of the manufacturer of the quality control sample or sample analyzer connected to computer 30a via the Internet, and registers it in the QC file. As a result, the information in the QC file stored in the storage device 35 of computer 30a is updated to include the information of the new lot.

[0033] Figure 5 shows an example of a QC file stored in the storage device 35. In Figure 5, the "Device ID" column shows identification information such as the identification number of the sample analyzer. The "Material" column shows the concentration level of the quality control sample, and the "Lot Number" column shows the lot number of the quality control sample. The "Measurement Sequence Number" is a number that increases by one with each measurement. The "Item ID" column shows the measurement item. "Target Value," "Limit Value (#)," and "Range (%)" show the target value, limit value (#), and limit value (#) ÷ target value of the measured value of the quality control sample, respectively.

[0034] When the process in step S20 (Figure 4B) is executed, the numerical values ​​(display values) specified by the manufacturer of the quality control sample are stored as the "Target Value," "Limit Value (#)," and "Range (%)" enclosed in the thick-lined box in Figure 5.

[0035] When the control unit 31 of the computer 30a executes the process in step S21, the user measures a new lot of quality control sample once or multiple times using the sample analyzer 2a. Each time a measurement is taken, the control unit 31 of the computer 30a analyzes the data representing the measurement value of the sample received from the measuring device 3a and stores the result in the storage device 35 as the measurement result of the quality control sample (S21).

[0036] Next, the control unit 31 of the computer 30a selects one measurement item from the measurement items subject to accuracy control (for example, the measurement items selected as targets for rule setting on the screen shown in Figure 8, which will be described later, or predetermined measurement items) (S22). The control unit 31 of the computer 30a determines whether or not a rule is set for the selected measurement item to generate a control standard value using the average value or statistical value (S23).

[0037] In step S23, the control unit 31 of the computer 30a determines that a rule has been set to generate a control reference value using the average value or statistical value for the selected measurement item (S23:Y). If so, it obtains the measurement results of the quality control sample and generates a control reference value for the new lot of quality control sample in the sample analyzers 2a, 2b, and 2c based on the rule set in step S10 (S24). This subroutine for generating the control reference value will be explained in detail later.

[0038] Next, the control unit 31 of the computer 30a applies the control reference values ​​generated in step S24 to the sample analyzers 2a, 2b, and 2c (S25). Specifically, the control unit 31 of the computer 30a overwrites the values ​​in the "Target Value," "Limit Value," and "Range" fields (values ​​specified by the manufacturer of the quality control sample) of the QC file stored in the storage device 35 with the target value, limit value (#), and limit value (#) ÷ target value of the sample analyzer 2a generated in step S24. The control unit 31 of the computer 30a also writes the target value, limit value (#), and limit value (#) ÷ target value of the sample analyzer 2a generated in step S24 to the "Target Value," "Limit Value," and "Range" fields of the QC file stored in the storage device 35 of the sample analyzers 2b and 2c. The control unit 31 of the computer 30a may also store the date and time of application of the control reference values ​​and the name of the user who performed the application in the storage device 35.

[0039] In step S23, the control unit 31 of computer 30a determines that no rule is set to generate a control reference value using an average or statistical value for the selected measurement item (S23:N), and then determines whether a rule is set to generate a control reference value using a value specified by the user for the selected measurement item (S26). In step S26, the control unit 31 of computer 30a determines that a rule is set to generate a control reference value using a value specified by the user for the selected measurement item (S26:Y), and then reads the value specified by the user from the storage device 35 (S27). Next, the control unit 31 of computer 30a applies the value read in step S27 as the control reference value to the sample analyzers 2a, 2b, and 2c (S25). Specifically, the control unit 31 of computer 30a overwrites the values ​​in the "Target Value," "Limit Value," and "Range" fields of the QC files stored in the respective storage devices 35 of computers 30a, 30b, and 30c (values ​​specified by the manufacturer of the quality control sample) with the target value (specified value), limit value (specified value (%)) × target value, and limit value (specified value (%)) read in step S27.

[0040] In step S26, the control unit 31 of the computer 30a determines that no rule is set for the selected measurement item to generate a control reference value using a value specified by the user (S26:N "Use displayed value"), and proceeds to step S28. In this case, a rule is set for the selected measurement item to use a value (displayed value) specified by the manufacturer of the quality control sample. Since the value specified by the manufacturer of the quality control sample is already stored in the "Target Value," "Limit Value," and "Range" fields of the QC file through the QC file registration process in step S20, the process in step S25 is skipped.

[0041] After processing in step S25, or after a negative result is determined in step S26, the control unit 31 of the computer 30a determines whether there are any other measurement items subject to quality control (S28). If the control unit 31 of the computer 30a determines in step S28 that there are other measurement items subject to quality control (S28:Y), it returns to step S22. If it determines that there are no other measurement items subject to quality control (S28:N), it terminates the application of the control standard value.

[0042] After the control standards for the new lot have been applied to the sample analyzer 2a, the user typically measures the quality control sample of the new lot using the sample analyzer 2a daily. As shown in Figure 4C, the control unit 31 of the computer 30a analyzes the data representing the measured values ​​of the sample received from the measuring device 3a and stores the result in the storage device 35 as the measurement result of the quality control sample (S31).

[0043] Next, the control unit 31 of the computer 30a reads the management reference values ​​(the numerical values ​​of "target value," "limit value," and "range") from the QC file stored in the storage device 35 (S32).

[0044] Then, the control unit 31 of the computer 30a outputs the read-out control reference value and the measurement result of the quality control sample as QC results to the display of the display input unit 50 (S33).

[0045] Figure 6 shows the subroutine for accepting the rule setting shown in step S10 of Figure 4A. In this process, first, the control unit 31 of the computer 30a accepts the selection of a reference analyzer from among the sample analyzers 2a, 2b, and 2c that will serve as the standard for quality control (S101). If no reference analyzer is selected, the process in step S101 can be omitted. Next, if the control unit 31 of the computer 30a uses the measurement results of quality control samples from past manufacturing lots (old lots) when calculating the control standard value (for example, limit value (#) and / or limit value (%CV)), it accepts the number of old lots (reference number) to be used in the calculation (S102). The processes in steps S101 and S102 may be performed in reverse order or simultaneously.

[0046] Figure 7 shows an example of the screen displayed on the display input unit 50 when selecting a reference analyzer in step S101 and receiving the old lot reference number in step S102. On this screen, the "Measurement Unit Name" field shows the names of the sample analyzers 2a, 2b, and 2c that the user has assigned in advance, and the "Analyzer ID" shows the identification information of the sample analyzers 2a, 2b, and 2c. The reference analyzer is selected by operating the mouse or keyboard of the display input unit 50 and selecting one of the checkboxes in the "Reference Analyzer" field.

[0047] The reference number for the previous lot can be selected by operating the mouse or keyboard on the display input unit 50 and selecting a value from the pull-down menu in the "Previous Lot Reference Setting" field. Figure 7 shows an example where "Sample Analyzer 2a" is selected as the reference analyzer and the past three lots are selected as the previous lot reference number.

[0048] In Figure 7, the "Display Color" column specifies different colors for each sample analyzer 2a, 2b, and 2c. These colors indicate the dots and lines displayed in the reference value setting support screen (Figures 14 and 15), which will be described later, to facilitate identification of each sample analyzer.

[0049] Returning to Figure 6, after step S102, the control unit 31 of the computer 30a accepts the selection of measurement items for which rules to be set for generating control reference values ​​(S103). The measurement items selected here are the items for which rules to be set for generating control reference values ​​will be applied. In step S103, the measurement items for which rules to be set for generating control reference values ​​are selected for each concentration level of the quality control sample.

[0050] Figure 8 shows an example of the screen displayed on the display input unit 50 when accepting the selection of measurement items to be subject to setting rules for generating control reference values. "Material" is a field for selecting the concentration level of the quality control sample. Quality control samples include, for example, low concentration levels, medium concentration levels, and high concentration levels. "Control Level 1" indicates the low concentration level, "Control Level 2" indicates the medium concentration level, and "Control Level 3" indicates the high concentration level. In Figure 8, "Control Level 1," which is the low concentration level, is selected, and in this state, the selection of measurement items to be subject to setting rules for generating control reference values, corresponding to "Control Level 1," is accepted. The "Item" field is each measurement item of the sample analyzer 2a, and by operating the mouse or keyboard of the display input unit 50 and selecting the checkbox in the "Setting Target" field, the corresponding measurement item is selected as the target for setting rules for generating control reference values. In Figure 8, RBC (red blood cell count), HGB (hemoglobin level), HCT (hemacrit), PLT (platelet count), and WBC (white blood cell count) are selected as parameters for setting rules to generate control reference values.

[0051] Returning to Figure 6, after step S103, the control unit 31 of the computer 30a accepts the setting of the target value generation rule (S104), and then accepts the setting of the limit value generation rule (S105). In steps S104 and S105, the setting of the target value and limit value generation rule is accepted for each concentration level of the quality control sample. Note that the processing in steps S104 and S105 may be performed in reverse order, or simultaneously.

[0052] Figure 9 shows an example of a screen displayed on the display input unit 50 when accepting the setting of target value and limit value generation rules. On this screen, as with the screen shown in Figure 8, the concentration level of the quality control sample is selected in the "Material" field.

[0053] The screen in Figure 9 displays Table 101, which includes "Setting Items," "Target," and "Limit," and the "Calculation Pattern" area 102. The "Setting Items" column in Table 101 displays all the measurement items selected in step S103. The "Target" and "Limit" columns in Table 101 display the target value generation rule and the limit value generation rule for the corresponding measurement items, respectively. Table 101 is configured so that any row can be selected by operating the mouse or keyboard on the display input unit 50, and the selected row is displayed in a different color from the other rows. In the example in Figure 9, the row with the measurement item RBC is selected. The "Calculation Pattern" area 102 displays the measurement item of the row selected in Table 101 (RBC in the example in Figure 9) as the item name. In other words, the screen in Figure 9 allows for the setting of generation rules for each measurement item.

[0054] The "Calculation Pattern" area 102 includes an area 103 for accepting the setting of a target value generation rule and an area 104 for accepting the setting of a limit value generation rule. The area 103 related to the target value includes an area 103a for accepting the setting of a rule to generate the target value using the average value of the new lot, an area 103b for accepting the setting of a rule to generate the target value using a value specified by the user, and an area 103c for accepting the setting of a rule to generate the target value using a value specified by the manufacturer of the quality control sample. The area 104 related to the limit value includes an area 104a for accepting the setting of a rule to generate the limit value using statistical values ​​of the new or old lot, an area 104b for accepting the setting of a rule to generate the limit value using a value specified by the user, and an area 104c for accepting the setting of a rule to generate the limit value using a value specified by the manufacturer of the quality control sample.

[0055] The user can select one of the following rules for generating target values: (1) Rule 1, which generates a control reference value based on measurement results obtained by measuring a quality control sample; (2) Rule 2, which generates a control reference value based on a value specified by the user; and (3) Rule 3, which generates a control reference value based on a value specified by the manufacturer of the quality control sample. When setting Rule 1, the user selects the checkbox for (1) "Use the average value of the new lot"; when setting Rule 2, the user selects the checkbox for (2) "Use the specified value"; and when setting Rule 3, the user selects the checkbox for (3) "Use the displayed value". If the user selects (1) "Use the average value of the new lot", they can further select one of the following as the target instrument: (1a) "Use the average value for each analyzer" checkbox, (1b) "Use the average value of the reference analyzer" checkbox, or (1c) "Use the average value of all analyzers" checkbox. In this way, the target value generation rule can be set by selecting a checkbox (option). If the checkbox for (1) "Use the average value of the new lot" is selected, a positive judgment is made in the process of step S23 (Figure 4B). (2) If the "Use specified value" checkbox is selected, a positive result is determined in step S26. (3) If the "Use displayed value" checkbox is selected, a negative result is determined in step S26.

[0056] Figure 10 shows the checkboxes (options), the text displayed in the "Target" column of Table 101 when a checkbox is selected, and the rules for generating target values. Specifically, when the checkbox in (1)(1a) above is selected, the text "Average value (per analyzer)" is displayed in the "Target" column of Table 101 in Figure 9. In this case, each of the sample analyzers 2a, 2b, and 2c measures the quality control sample of the new lot multiple times, and each of the computers 30a, 30b, and 30c executes the process in step S24 (Figure 4B) based on the multiple measurement results obtained by the corresponding sample analyzers 2a, 2b, and 2c, thereby generating individual target values ​​for each of the sample analyzers 2a, 2b, and 2c.

[0057] If the checkboxes in (1)(1b) above are selected, the "Target" column in Table 101 of Figure 9 will display the text "Average Value (Reference Analyzer)". In this case, the sample analyzer selected as the reference analyzer on the screen in Figure 7 (sample analyzer 2a in the example of Figure 7) measures the quality control sample of the new lot multiple times, and the corresponding computer 30a executes the process in step S24 (Figure 4B) based on the multiple measurement results obtained by sample analyzer 2a, thereby generating a target value that is commonly applied to each of the sample analyzers 2a, 2b, and 2c.

[0058] If the checkboxes in (1)(1c) above are selected, the "Target" column in Table 101 of Figure 9 will display the text "Average Value (All Analytical Instruments)". In this case, each of the sample analyzers 2a, 2b, and 2c measures the quality control sample of the new lot multiple times, and the computer 30a performs the process in step S24 (Figure 4B) based on all the measurement results obtained by the sample analyzers 2a, 2b, and 2c, thereby generating a target value that is commonly applied to each of the sample analyzers 2a, 2b, and 2c.

[0059] If the checkbox in (2) above is selected, the value entered by the user in area 103b by operating the mouse or keyboard on the display input unit 50 will be displayed in the "Target" column of Table 101 in Figure 9. In this case, the value displayed in the "Target" column will be the target value that is applied commonly to each of the sample analyzers 2a, 2b, and 2c.

[0060] If the checkbox in (3) above is selected, the "Target" column in Table 101 of Figure 9 will display the target value specified by the manufacturer of the quality control sample. The target value specified by the manufacturer of the quality control sample is recorded in the "Target Value" column of the QC file (Figure 5) stored in the storage device 35. In this case, the value displayed in the "Target" column will be the target value that is commonly applied to each of the sample analyzers 2a, 2b, and 2c.

[0061] For generating limit values, users can select one of the following rules: (4) Rule 1, which generates a control standard value based on measurement results obtained by measuring quality control samples; (5) Rule 2, which generates a control standard value based on a value specified by the user; or (6) Rule 3, which generates a control standard value based on a value specified by the manufacturer of the quality control samples. When setting Rule 1, the user selects the (4) "Use statistical values" checkbox; when setting Rule 2, the user selects the (5) "Use specified values" checkbox; and when setting Rule 3, the user selects the (6) "Use displayed values" checkbox. If the user selects (4) "Use statistical values," they can further choose whether to calculate the limit value from the measurement results of new lot quality control samples or from old lot quality control samples by selecting one of the (4a) "New lot" checkbox or (4b) "Old lot" checkboxes. Furthermore, as the target device, one can be selected from the following checkboxes: (4a1) (4b1) "Use statistical values ​​for each analyzer", (4b1) (4b2) "Use statistical values ​​for the reference analyzer", and (4a1) (4b1) "Use statistical values ​​for all analyzers". In this way, the limit value generation rule can be set by selecting a checkbox (option). (4) If the "Use statistical values" checkbox is selected, the process in step S23 (Figure 4B) is judged positively. (5) If the "Use specified value" checkbox is selected, the process in step S26 is judged positively. (6) If the "Use displayed value" checkbox is selected, the process in step S26 is judged negatively.

[0062] Figures 11A and 11B show the checkboxes (options), the text displayed in the "Limit" column of Table 101 when a checkbox is selected, and the rules for generating limit values. Specifically, when the checkboxes in (4)(4a)(4a1) above are selected, the text "New Lot (per analyzer)" is displayed in the "Limit" column of Table 101 in Figure 9. In this case, each of the sample analyzers 2a, 2b, and 2c measures the quality control sample of the new lot multiple times, and each of the computers 30a, 30b, and 30c executes the process in step S24 (Figure 4B) based on the multiple measurement results obtained by the corresponding sample analyzers 2a, 2b, and 2c, thereby generating individual limit values ​​for each of the sample analyzers 2a, 2b, and 2c.

[0063] If the checkboxes (4)(4a)(4a2) above are selected, the words "New Lot (Reference Analyzer)" will be displayed in the "Limit" column of Table 101 in Figure 9. In this case, the sample analyzer selected as the reference analyzer on the screen in Figure 7 (sample analyzer 2a in the example in Figure 7) measures the quality control sample of the new lot multiple times, and the corresponding computer 30a executes the process in step S24 (Figure 4B) based on the multiple measurement results obtained by sample analyzer 2a, thereby generating a limit value that is commonly applied to each of the sample analyzers 2a, 2b, and 2c.

[0064] If the checkboxes (4)(4a)(4a3) above are selected, the "Limit" column in Table 101 of Figure 9 will display the words "New Lot (All Analytical Instruments)". In this case, each of the sample analyzers 2a, 2b, and 2c measures the quality control sample of the new lot multiple times, and the computer 30a performs the process in step S24 (Figure 4B) based on all the measurement results obtained by the sample analyzers 2a, 2b, and 2c, thereby generating a limit value that is commonly applied to each of the sample analyzers 2a, 2b, and 2c.

[0065] If the checkboxes (4), (4b), and (4b1) above are selected, the "Limit" column in Table 101 of Figure 9 will display the words "Previous Lot (per analyzer)". In this case, the same process as when the checkboxes (4), (4a), and (4a1) are selected is performed based on the measurement results of the quality control samples from the previous lot, thereby generating individual limit values ​​for each of the sample analyzers 2a, 2b, and 2c.

[0066] If the checkboxes (4), (4b), and (4b2) above are selected, the "Limit" column in Table 101 of Figure 9 will display the words "Old Lot (Reference Analyzer)". In this case, the same process as when the checkboxes (4), (4a), and (4a2) are selected is performed based on the measurement results of the quality control sample from the old lot, thereby generating limit values ​​that are commonly applied to each of the sample analyzers 2a, 2b, and 2c.

[0067] If the checkboxes (4), (4b), and (4b3) above are selected, the "Limit" column in Table 101 of Figure 9 will display the words "Old Lot (All Analytical Instruments)". In this case, the same process as when the checkboxes (4), (4a), and (4a3) are selected is performed based on the measurement results of the quality control samples from the old lot, thereby generating limit values ​​that are commonly applied to each of the sample analytical instruments 2a, 2b, and 2c. In generating the limit value, the number of old lot quality control samples used will follow the number selected in the "Reference Count" column in Figure 7 (if the "Old Lot" checkbox is selected in the screen shown in Figure 13, which will be described later, that selection will be followed).

[0068] If the user selects (4) "Use statistical values," the mSD (where m is a selectable value from 1, 2, 3, or 4) is also displayed below the "Use statistical values" section in area 104a of Figure 9. By operating the mouse or keyboard on the display input unit 50 to select a value for m, the user can choose to determine the limit value (#) and limit value (%CV) as the standard deviation and coefficient of variation, respectively, multiplied by m. For example, 3SD is the standard deviation of 3σ.

[0069] If the checkbox in (5) above is selected, the value entered by the user in area 104b by operating the mouse or keyboard on the display input unit 50 will be displayed in the "Limit" column of Table 101 in Figure 9. In this case, the value displayed in the "Limit" column will be the limit value that is applied commonly to each of the sample analyzers 2a, 2b, and 2c.

[0070] If the checkbox in (6) above is selected, the limit value (#) specified by the manufacturer of the quality control sample will be displayed in the "Limit" column of Table 101 in Figure 9. The limit value (#) specified by the manufacturer of the quality control sample is recorded in the "Limit Value" column of the QC file (Figure 5) stored in the storage device 35. In this case, the value displayed in the "Limit" column will be the limit value that applies commonly to each of the sample analyzers 2a, 2b, and 2c.

[0071] Figure 12 shows the subroutine for S24 in Figure 4B. As explained in Figure 4B above, when registering quality control samples for a new lot, in S24, the control unit 31 of the computer 30a acquires the measurement results of the quality control samples and generates a control standard value based on the rule set in S10 in Figure 4A.

[0072] The control unit 31 of the computer 30a accepts the selection of measurement results for quality control samples to be used in generating control reference values ​​(S211). Figure 13 shows an example of the screen displayed on the display input unit 50 when accepting the selection of measurement results. "Material" is a field for selecting the concentration level of the quality control sample. This makes it possible to select measurement results for each concentration level of the quality control sample. In the "Lot" table 110, the quality control samples for which measurement results are stored are displayed by lot number, in descending order from the newest registration date. The quality control sample with lot number QC-03571101 displayed in the first row is a new lot, and the other quality control samples are old lots. In this display, the measurement results of the quality control samples for which the "Target" or "Old Lot" checkbox is selected are selected. If "New Lot" is selected in area 104a of the screen in Figure 9, the screen in Figure 13 will be displayed with only the checkbox in the "Target" column corresponding to the quality control sample with lot number QC-03571101, which is a new lot, selected. If "Old Lot" is selected in area 104a of the screen in Figure 9, the screen in Figure 13 will be displayed with the checkbox in the "Old Lot" column selected according to the reference number selected in "Reference Number" in Figure 7. The screen in Figure 13 shows an example where "New Lot" is selected in area 104a of the screen in Figure 9. If the user wishes to change the selection, they can do so by operating the mouse or keyboard of the display input unit 50 to select the checkbox for "Target" or "Old Lot".

[0073] Area 111 of the "Acquired Plots" in Figure 13 is for selecting the measurement results to be used to generate the control limit from the measurement results of the quality control samples selected in Table 110 of the "Lot". If the "All Plots" checkbox is selected, all measurement results of the quality control samples selected in Table 110 of the "Lot" will be used to generate the control limit. If the "Start Plot: After Calibration_End Plot: Final Plot" checkbox is selected, the measurement results of the quality control samples selected in Table 110 of the "Lot" that were obtained after calibration processing was performed on the sample analyzers 2a, 2b, and 2c on which the measurements were performed will be used to generate the control limit. If the "Period" checkbox is selected, the measurement results of the quality control samples selected in Table 110 of the "Lot" that were obtained during the period from the date entered in the "Start Date" column to the date entered in the "End Date" column will be used to generate the control limit. When the "Plot Number" checkbox is selected, the measurement results of the quality control samples selected in Table 110 under "Lot," from the value entered in the "Start Plot" column to the value entered in the "End Plot" column, will be used to generate the control standard value. For example, in the example in Figure 13, the measurement results from the first obtained to the 300th obtained will be used to generate the control standard value.

[0074] After the selection of the checkboxes in Figure 13 is completed and the OK button is selected, in step S212 of Figure 12, the control unit 31 of computer 30a reads the measurement results from the storage device 35 according to the selection. If the selected measurement results are not stored in the storage device 35 of computer 30a, the control unit 31 of computer 30a requests and receives the measurement results of quality control samples necessary for generating control reference values ​​from the computers 30b and 30c of the other sample analyzers 2b and 2c. For example, if the checkboxes (1)(1a), (1)(1c), (4), (4a)(4a1), or (4)(4a)(4a3) above are selected, the control unit 31 of computer 30a requests and receives the measurement results of quality control samples necessary for generating control reference values ​​from the computers 30b and 30c.

[0075] Next, the control unit 31 of the computer 30a generates a target value (S213). Based on the rule accepted in step S10, the control unit 31 of the computer 30a calculates the average of the multiple measurement results acquired in step S212 and generates a target value (S213). Next, the control unit 31 of the computer 30a generates a limit value (S214). Based on the rule accepted in step S10, the control unit 31 of the computer 30a calculates the standard deviation and coefficient of variation of the multiple measurement results acquired in step S212 and generates a limit value (S214). Note that the execution order of processes S213 and S214 may be reversed.

[0076] Next, in S215 of Figure 12, the control unit 31 of the computer 30a displays a reference value setting support screen on the display input unit 50, which includes the target value and limit value (control reference value) generated in steps S213 and 214. The reference value setting support screen is initially displayed in the chart graph display mode shown in Figure 14, and can be switched to the % graph display mode shown in Figure 15. Figure 14 shows an example of the reference value setting support screen displayed in chart graph display mode. The reference value setting support screen can be displayed for each concentration level of the quality control sample and for each measurement item. The screen in Figure 14 shows an example where the quality control sample is a new lot, the concentration level of the quality control sample is "Control Level 1", the measurement item is RBC, and the average value and statistical value for each analyzer are selected as the rules for generating the control reference value. The reference value setting support screen includes a toolbar area 60 at the top of the screen, a material area 80 located below the toolbar area 60, and a chart graph area 90 located below the material area 80. The toolbar area 60 and the material area 80 are common screen areas for both the chart graph display mode and the percentage graph display mode, and their display content does not change when switching modes.

[0077] The toolbar area 60 displays buttons such as button 61 for switching the screen of the chart graph area 90 to chart graph display mode, button 71 for switching the screen of the chart graph area 90 to percentage graph display mode, and button 72 for switching the reference value setting support screen to the internal quality control setting sheet screen shown in Figure 16. The material area 80 displays the concentration level of the quality control sample, lot number, registration date of the measurement result, the names of the sample analyzers 2a, 2b, and 2c that are the target of generating the control reference value, the number of measurements of the quality control sample, and the number of measurement days.

[0078] The chart graph area 90 displays a target value display area 62 for displaying the generated target values ​​for each sample analyzer 2a, 2b, and 2c, a limit value display area 63 for displaying the generated limit values ​​for each sample analyzer 2a, 2b, and 2c, and a chart graph area 64 for displaying the chart graph.

[0079] The vertical axis of chart graph area 64 indicates the magnitude of the RBC count. The horizontal center line 69 of chart graph area 64 indicates the target value provided by the manufacturer of the quality control sample. Area 65 is the area showing the control reference value for sample analyzer 2a, where point 65a indicates the target value calculated in step S213, the two dotted lines 65b indicate the limit value calculated in step S214 (in this example, the limit value is 3SD of the target value), and the vertical line 65c indicates the range of 2SD of the target value. Areas 66 and 67 are the areas showing the control reference values ​​for sample analyzers 2b and 2c, respectively, and, similar to area 65, show the target value, limit value, etc. Area 68 is the area showing the target value generated based on the measurement results obtained from all sample analyzers 2a, 2b, and 2c, and shows the average value of the measurement results and the range of 2SD of the average. From the displays in areas 65 to 68, the user can get an overview of the control reference values ​​for sample analyzers 2a, 2b, and 2c.

[0080] The horizontal axis on the right half of the chart graph area 64 shows the number of measurements for quality control samples, representing the first, second, and third measurements from left to right. Three line graphs 70 are shown for each sample analyzer 2a, 2b, and 2c. The height of the plots on each line graph indicates the magnitude of the RBC count. Each line graph 70 is displayed in the color specified in the "Display Color" column of Figure 7, making it easy to identify which line graph corresponds to which sample analyzer. The display of line graphs 70 allows users to compare and confirm the trends in the measurement results for each sample analyzer 2a, 2b, and 2c, and to check the variability and fluctuation trends of the measurement results.

[0081] In the toolbar area 60 of Figure 14, selecting button 71 switches the display of the chart graph area 90 from chart graph display mode to the percentage graph display mode shown in Figure 15.

[0082] Figure 15 shows an example of a reference value setting support image where the display of the chart graph area 90 has been switched to percentage graph display mode. The coefficient of variation graph 75 is displayed in the chart graph area 90. The vertical axis of the coefficient of variation graph 75 indicates the magnitude of the coefficient of variation. The coefficient of variation graph 75 displays line graphs 75a, 75b, and 75c for each of the sample analyzers 2a, 2b, and 2c, respectively. The open rectangles in line graphs 75a, 75b, and 75c represent the coefficient of variation of the measurement results of quality control samples from the old lot, with the leftmost rectangle representing the older lot. The filled rectangles in line graphs 75a, 75b, and 75c represent the coefficient of variation of the measurement results of quality control samples from the new lot. Using line graphs 75a, 75b, and 75c, the user can compare and confirm the magnitude of the coefficient of variation of the measurement results and the trend of the coefficient of variation for each of the sample analyzers 2a, 2b, and 2c.

[0083] The user determines whether the generated target value and limit value are appropriate based on the information displayed on the reference value setting support screen in Figures 14 and 15. If the user determines that they are appropriate, they select button 72 in the toolbar area 60.

[0084] In step S216 of Figure 12, the control unit 31 of the computer 30a displays the internal accuracy control setting sheet on the display of the display input unit 50.

[0085] Figures 16 and 17 show examples of the display of the internal quality control setting sheet 73. The internal quality control setting sheet 73 is a sheet in which the generated control standard values ​​are displayed in a format compatible with external certifications such as ISO certification. The internal quality control setting sheet 73 is also stored as an electronic file in the storage device 35 and can be printed using a printer.

[0086] Figure 16 shows the upper half of the internal accuracy control setting sheet 73, and by operating the scroll bar 78, the lower half of the internal accuracy control setting sheet 73 shown in Figure 17 is displayed. The upper half of the internal accuracy control setting sheet 73 shown in Figure 16 displays Table 73a, which includes the fields for creator, creation date, approver, and approval date, in a format that can also be used as a report. In Table 73a, it is possible to enter characters into the blank fields for each item using the keyboard of the display input unit 50. Therefore, the user may enter information such as creator and approver in Table 73a and print the internal accuracy control setting sheet 73, or they may print the internal accuracy control setting sheet 73 with Table 73a blank and fill in the information such as creator and approver by hand. As an example, in Table 73a, the creator may enter the information using the keyboard of the display input unit 50, and the creation date may be automatically entered by the control unit 31a. In this case, the creator prints the internal accuracy control setting sheet 73, and the approver fills in the approver's name and approval date by hand.

[0087] The upper half of the internal quality control setting sheet 73 further displays information about the quality control samples and sample analyzers subject to approval by the approver. The lower half of the internal quality control setting sheet 73, shown in Figure 17, displays the generated target values ​​and limit values ​​for each sample analyzer and each measurement item.

[0088] In the display screens shown in Figures 16 and 17, a checkbox indicating the setting of registration details is displayed on the right. When this checkbox is selected, it is possible to register either the target value or the limit value. If "Register TARGET only" is selected, the target value of the new lot generated in step S213 is registered, and the limit value (%CV) is inherited from the value previously applied to the sample analyzer 2a. If "Register LIMIT only" is selected, the limit value (%CV) of the new lot generated in step S214 is registered, and the target value is inherited from the value previously applied to the sample analyzer 2a. Regardless of whether "Register TARGET only" or "Register LIMIT only" is selected, the limit value (#) is recalculated based on the target value or the limit value (%CV) of the new lot.

[0089] If the creator determines that the control standard value is appropriate, they operate the mouse on the display input unit to select the save button, store the contents of the internal quality control setting sheet in the storage device 35, and then request approval from the approver. After obtaining approval from the approver, the creator selects the register button 74 on the display screens shown in Figures 16 and 17. On the other hand, if the generated control standard value needs to be reconfirmed, the creator selects the cancel button 76 on the display screens shown in Figures 16 and 17.

[0090] Returning to Figure 12, the control unit 31 of computer 30a determines in step S217 whether the register button 74 or the cancel button 76 was selected. If the register button 74 is selected ("registered" in step S217), the control unit 31 of computer 30a returns processing to the main routine in Figure 4B, and in step S25, applies the target value generated in step S213 and the limit value generated in step S214 to the sample analyzers 2a, 2b, and 2c. Specifically, the control unit 31 of computer 30a overwrites the target value in the "Target Value" field of the QC file (Figure 5) stored in the storage device 35 of computers 30a, 30b, and 30c, and overwrites the limit value (#) and limit value (#) ÷ target value in the "Limit Value (#)" and "Range (%)" fields, respectively. As a result, the target value generated in step S213 and the limit value generated in step S214 become the control reference values ​​used in internal quality control. The target value generated in step S213 and the limit value generated in step S214 are then read out in the process of step S32 in Figure 4C.

[0091] As described above, the control unit 31 of the computer 30a outputs management standard values ​​to the user in a format compatible with external certifications such as ISO certification. Therefore, the user can apply the management standard values ​​to the device after confirming all the information necessary for certification. This allows for efficient operation tailored to the facility obtaining external certification.

[0092] According to the method for applying control reference values ​​to the sample analyzers 2a, 2b, and 2c described above, and the sample analyzers 2a, 2b, and 2c, as well as the reference value application program, the tasks of inputting measurement results of quality control samples into the computers 30a, 30b, and 30c by the staff of the testing facility, and inputting the obtained control reference values ​​into the sample analyzers 2a, 2b, and 2c, are eliminated, thereby streamlining the determination of control reference values ​​and their application to the sample analyzers at the testing facility.

[0093] Furthermore, in the above embodiment, the computer 30a applies control reference values ​​to the sample analyzers 2a, 2b, and 2c. This reduces the labor required for the user to apply control reference values ​​to each of the sample analyzers 2a, 2b, and 2c.

[0094] Furthermore, in the above embodiment, the computer 30a accepts rule settings for each concentration level of the quality control sample. This makes it possible to set optimal control reference values ​​according to the facility for each concentration level (attribute) of the quality control sample.

[0095] Furthermore, in the above embodiment, rule settings are accepted by selecting checkboxes (options). This allows users to easily determine management standard values ​​simply by selecting a pattern appropriate for their facility.

[0096] Furthermore, in the above embodiment, if the first rule is selected, the computer 30a generates a control reference value based on multiple measurement results. This makes it possible to obtain a control reference value that appropriately reflects the state of the device.

[0097] Furthermore, in the above embodiment, the range of measurement results used to generate the control standard value can be specified. This makes it easy to implement operations tailored to the facility, for example, in facilities that want to exclude measurement results of quality control samples obtained within a specific period from the calculation of the control standard value.

[0098] Furthermore, in the above embodiment, if "use the average value for each analyzer" or "use the statistical value for each analyzer" is selected as the first rule, individual control reference values ​​are generated for each of the sample analyzers 2a, 2b, and 2c. This makes it easy for facilities that wish to operate with different control reference values ​​for each sample analyzer 2a, 2b, and 2c to operate in a way that suits their needs.

[0099] Furthermore, in the above embodiment, if "use the average value of the reference analyzer" or "use the statistical value of the reference analyzer" is selected as the first rule, the control reference value generated for the sample analyzer 2a, which is the reference analyzer, can be applied as a common control reference value to sample analyzers 2a, 2b, and 2c. This makes it easy for facilities that want to apply the control reference value obtained from the reference analyzer to other analyzers within the facility to implement operations tailored to their specific needs.

[0100] Furthermore, in the above embodiment, if the first rule is "use the average value of all analyzers" or "use the statistical value of all analyzers," the control reference value generated based on the measurement results obtained from all of the sample analyzers 2a, 2b, and 2c can be applied as a common control reference value to all of the sample analyzers 2a, 2b, and 2c. This makes it easy for facilities that want to apply the control reference value obtained from all of the multiple sample analyzers 2a, 2b, and 2c within the facility to each of the sample analyzers 2a, 2b, and 2c within the facility to implement operations tailored to their specific needs.

[0101] Furthermore, in the above embodiment, if the first rule is selected, measurement results obtained from quality control samples of manufacturing lots prior to the new lot (old lots) can be used to calculate the control standard value. This makes it easy for facilities that want to adopt a control standard value that reflects long-term variability in measurement results to implement operations tailored to their specific needs.

[0102] Furthermore, in the above embodiment, if the first rule is selected, the computer 30a displays a reference value setting support screen that includes the generated reference value and the multiple measurement results used to generate the reference value. This allows the user to confirm the generated reference value and the multiple measurement results used to generate the reference value, and to consider the validity of the generated reference value.

[0103] Furthermore, in the above embodiment, a second rule can be selected that generates a management standard value based on a value specified by the user. This allows facilities that wish to use a management standard value based on a user-specified value to efficiently implement operations tailored to their specific needs.

[0104] Furthermore, in the above embodiment, a third rule can be selected to generate control reference values ​​based on values ​​specified by the manufacturer of the quality control samples. This allows facilities that wish to use control reference values ​​based on values ​​specified by the manufacturer to efficiently implement operations tailored to their specific needs.

[0105] Furthermore, in the above embodiment, the computer 30a accepts the setting of rules for each measurement item. This makes it easy to operate the system in a way that suits facilities that want to use different control reference values ​​depending on the measurement item, such as facilities that want to use values ​​specified by the manufacturer for certain measurement items, while using control reference values ​​generated based on the measurement results for other measurement items. For example, for measurement items such as hemoglobin (HGB), where the measured values ​​of quality control samples are known to fluctuate very little, some facilities use values ​​specified by the manufacturer, and this system can easily accommodate such facilities as well.

[0106] In the above embodiment, the reference value application program is provided to the computer 30a by a portable recording medium, but it may also be provided via a telecommunications line from an external device that is connected to the computer 30a via a telecommunications line (whether wired or wireless).

[0107] In the above embodiment, the computer 30a is located within the user's facility, but it may also be configured to be located in the cloud, with the measuring device 3a located within the facility and the computer 30a connected via the internet.

[0108] In the above embodiment, the measuring device 3a and the computer 30a are configured as separate devices, but the functions of the computer 30a may be built into the measuring device 3a and configured as an integrated device.

[0109] In the above embodiment, a hemocytometer for counting blood cells contained in a blood sample was described. However, the sample analyzed by the hemocytometer is not limited to blood, and may also be other bodily fluids such as lymph or body cavity fluid. In this case, the rules for determining the reference value may be configured to accept settings for each type (attribute) of bodily fluid targeted by the quality control sample.

[0110] In the above embodiment, a blood cell counter was described, but the specimen analyzer is not limited to this, and may be other specimen analyzers that perform quality control using quality control samples, such as biochemical analyzers, immunoassay analyzers, blood coagulation analyzers, urine analyzers, and gene analyzers.

[0111] In the above embodiment, a case in which the sample analysis system 1 includes multiple sample analyzers 2a, 2b, and 2c has been described, but the system is not limited thereto, and the sample analysis system may be configured to include only the sample analyzer 2a.

[0112] In the above embodiment, the computer 30a can accept the settings of the first rule, the second rule, and the third rule, but is not limited to this, and the computer 30a may be configured to accept only the first rule. Alternatively, the computer 30a may be configured to automatically store the first rule when the reference value application program is installed and not accept the setting of the rule. [Explanation of Symbols]

[0113] 1 Sample analysis system, 2a, 2b, 2c Sample analyzer, 3 Measurement device, 4 Control unit, 5 Communication unit, 6 Measurement unit, 7 Sample aspiration unit, 8 Sample preparation unit, 10 Measurement unit, 11 Electrical resistance detection unit, 12 Optical detection unit, 13 Hemoglobin measurement unit, 30a, 30b, 30c Computer, 31 Control unit, 32 CPU, 33 ROM, 34 RAM, 35 Storage device, 36 Input / output interface, 37 Reader, 38 Communication interface, 39 Input / output interface, 50 Display input unit, 60 Toolbar, 61 Mark.

Claims

1. A method for applying control reference values ​​for quality control samples to multiple sample analyzers in the same facility using a computer for internal quality control, The system accepts the setting of rules for generating the control reference value based on the measurement results of the quality control sample measured by at least one of the plurality of sample analyzers, and generates the control reference value based on the measurement results according to the accepted rules. The control reference value is applied to the sample analyzer, In generating the aforementioned control reference value, if the received rule is the first option of the first rule, an individual control reference value is generated for each of the multiple sample analyzers, and if the received rule is the second option of the first rule, a common control reference value is generated for each of the multiple sample analyzers. Applying the aforementioned control standard value means applying the aforementioned control standard value to each of the multiple sample analyzers. A method for applying control reference values ​​to a sample analyzer.

2. Accepting the setting of the aforementioned rules means accepting the setting of the aforementioned rules for each attribute of the quality control sample, A method for applying a control reference value to a sample analyzer according to claim 1, wherein the attribute is the concentration level of a predetermined component contained in the quality control sample or the type of body fluid targeted by the quality control sample.

3. A method for applying a control reference value to a sample analyzer according to claim 1 or 2, wherein the setting of the rule includes selecting options for setting the rule.

4. A method for applying a control standard value to a sample analyzer according to any one of claims 1 to 3, wherein, when the accepted rule is the first option, each of the plurality of sample analyzers generates the individual control standard value based on a plurality of measurement results obtained by measuring the quality control sample multiple times, and when the accepted rule is the second option, each or one of the plurality of sample analyzers generates the common control standard value based on a plurality of measurement results obtained by measuring the quality control sample multiple times.

5. A method for applying a control standard value to a sample analyzer according to any one of claims 1 to 4, wherein, in the case where the accepted rule is the second option, one of the plurality of sample analyzers generates the common control standard value based on a plurality of measurement results obtained by measuring the quality control sample multiple times.

6. A method for applying a control standard value to a sample analyzer according to any one of claims 1 to 4, wherein, when the accepted rule is the second option, each of the plurality of sample analyzers generates the common control standard value based on a plurality of measurement results obtained by measuring the quality control sample multiple times.

7. In generating the control reference value, if the received rule is a second rule, the user is allowed to input a specified value, and in applying the control reference value, the user is allowed to apply the specified value as the control reference value to each of the plurality of sample analyzers. A method for applying a control reference value to a specimen analyzer according to any one of claims 1 to 6.

8. In generating the control reference value, if the accepted rule is a third rule, the value specified by the manufacturer of the quality control sample is obtained, and in applying the control reference value, the value specified by the manufacturer is applied as the control reference value to each of the plurality of sample analyzers. A method for applying a control reference value to a specimen analyzer according to any one of claims 1 to 7.

9. A method for applying control reference values ​​to a sample analyzer according to any one of claims 1 to 8, wherein the acceptance of the setting of the aforementioned rules allows the setting of the aforementioned rules for each measurement item, for at least some of the multiple measurement items.

10. A method for applying a control reference value to a sample analyzer according to any one of claims 1 to 9, wherein the control reference value includes a value indicating a target value and a value indicating an acceptable range.

11. A method for applying a control reference value to a sample analyzer according to claim 10, wherein the setting of the rule is accepted for each of the target value and the tolerance range.

12. A method for applying a control reference value to a sample analyzer according to any one of claims 1 to 11, further comprising generating the control reference value based on the measurement results and displaying screen information including the generated control reference value and the measurement results.

13. The generated management standard values ​​are further provided to be output in a format compatible with external authentication. A method for applying a control standard value to a sample analyzer according to any one of claims 1 to 12, wherein applying the control standard value is performed when an input relating to the registration of the outputted control standard value is received.

14. A method for applying a control reference value to a sample analyzer according to claim 13, wherein the format includes a creation date field, and the creation date is automatically generated.

15. A method for applying a control standard value to a sample analyzer according to any one of claims 1 to 14, wherein, when the control standard value is applied, history information including the name of the user who instructed the application and the date and time of execution is stored in the computer.

16. A computer for applying control reference values ​​for quality control samples to multiple sample analyzers in the same facility for internal quality control, The system accepts the setting of rules for generating the control reference value based on the measurement results of the quality control sample measured by at least one of the plurality of sample analyzers, and generates the control reference value based on the measurement results according to the accepted rules. The control reference value is applied to the sample analyzer, In generating the aforementioned control reference value, if the received rule is the first option of the first rule, an individual control reference value is generated for each of the multiple sample analyzers, and if the received rule is the second option of the first rule, a common control reference value is generated for each of the multiple sample analyzers. The application of the aforementioned control standard value is a computer program that causes the computer program to apply the aforementioned control standard value to each of the multiple sample analyzers.

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