A quality control method, system, analyzer and computer storage medium

By using quality control methods and systems, quality control test results are obtained and rule judgments are made, which solves the problem that the status of quality control items is difficult to judge intuitively in the existing technology. It realizes the visualization of the controllable status and the prompt of the cause of loss of control, thereby improving the accuracy and efficiency of quality control testing.

CN115798659BActive Publication Date: 2026-03-24ZYBIO INC
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2022-12-02
Publication Date
2026-03-24

AI Technical Summary

Technical Problem

In existing technologies, the way quality control test results are presented cannot intuitively determine the quality control status of multiple quality control products, making it difficult for users to determine whether a project is under control.

Method used

A quality control method is provided, which obtains quality control test applications and results, judges quality control rules, determines the quality control status, and displays the quality control items and their results on a visual interface, including out-of-control and in-control status, and displays the reasons for out-of-control and the number of out-of-control items.

Benefits of technology

It enables intuitive judgment of the controlled state, helps users quickly identify and resolve out-of-control issues in quality control projects, and improves the accuracy and efficiency of quality control testing.

✦ Generated by Eureka AI based on patent content.

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Abstract

The application discloses a quality control method, comprising: obtaining a quality control test application and a quality control test result; performing quality control rule judgment on the quality control test result of the at least one quality control product to determine the quality control state of the at least one quality control product; the quality control state comprises out of control and in control; obtaining the quality control result of the quality control project based on the quality control state of the at least one quality control product, wherein the quality control result comprises in control and out of control; and performing visual display on the quality control project and the quality control result corresponding to the quality control project on a visual interface. Therefore, the application displays whether the quality control state of the project is in control in units of projects, and displays specific out-of-control reasons and the number of out-of-control reasons if the quality control state is not in control. The presentation mode can help users to determine whether the project is in control today to some extent, thereby solving the technical defects that users cannot intuitively determine whether the project is in control from a quality control overview page in the prior art.
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Description

Technical Field

[0001] This invention relates to the field of quality control, and specifically to a quality control method, system, analyzer, and computer storage medium. Background Technology

[0002] In practice, patient samples are typically tested only once before a report is issued; therefore, the accuracy and reliability of the test results are paramount. Since typical hospital laboratory departments are not standard or reference laboratories, hospitals employ quality control testing to ensure the accuracy of sample test results. Quality control testing is a crucial part of laboratory work; almost all laboratories use quality control materials for testing daily.

[0003] During quality control testing, some instruments only display the current quality control status of the control products and the corresponding "in control" status of the results, but do not determine whether the project is actually under control. This presentation method leads to one problem: when multiple projects use multiple quality control products for multiple quality control tests on the same day, due to the large number of control products used, users cannot intuitively determine whether the project is under control. Summary of the Invention

[0004] In view of the shortcomings of the prior art described above, the purpose of this invention is to provide a quality control method, system, analyzer, and computer storage medium to overcome the deficiencies of the prior art.

[0005] To achieve the above and other related objectives, the present invention provides a quality control method, comprising:

[0006] Obtain quality control test requests and quality control test results. The quality control test request is generated by the user through a trigger operation after determining the quality control item and at least one quality control product associated with the quality control item. The quality control test result is obtained after the quality control test is completed in response to the quality control test request.

[0007] The quality control test results of the at least one quality control item are used to determine the quality control status of the at least one quality control item by applying quality control rules; the quality control status includes out of control and under control.

[0008] The quality control results of the quality control items are obtained based on the quality control status of the at least one quality control item, and the quality control results include whether the items are under control or out of control.

[0009] The quality control items and their corresponding results are displayed visually in the visualization interface.

[0010] In one embodiment of the present invention, obtaining the quality control result of the quality control item based on the quality control status of the at least one quality control product includes:

[0011] Obtain a first quality control sample and a second quality control sample. The first quality control sample is the same quantity of quality control samples as the preset quality control level, and the second quality control sample is the first quality control sample whose quality control status is under control. The quality control level is the minimum number of quality control samples required for a single quality control item.

[0012] The ratio of the quantity of the second quality control product to the quantity of the first quality control product is compared with a preset value to obtain a comparison result, and the quality control result of the quality control item is obtained based on the comparison result.

[0013] In one embodiment of the present invention, when the ratio of the quantity of the second quality control product to the quantity of the first quality control product is equal to or greater than the preset value, the quality control result is under control; when the ratio of the quantity of the second quality control product to the quantity of the first quality control product is less than the preset value, the quality control result is out of control.

[0014] In one embodiment of the present invention, when the quality control test result triggers the quality control rule, the quality control state is out of control; when the quality control test result does not trigger the quality control rule, the quality control state is under control.

[0015] In one embodiment of the present invention, when visually displaying the quality control results of the quality control items, if the quality control results are out of control, the first quality control status identifier of the quality control items, the number of quality control products in the quality control items whose quality control status is out of control, and the reason for the out of control are displayed in a first display mode; if the quality control results are in control, the second quality control status identifier is displayed in a second display mode.

[0016] In one embodiment of the present invention, the quality control method further includes:

[0017] Based on the quality control results of the quality control items, quality control operation prompts are generated. The quality control operation prompts are at least used to indicate quality control tests for the quality control items. The quality control operation prompts include: increasing the quantity of quality control items and modifying the quality control items.

[0018] In one embodiment of the present invention, the quality control method further includes:

[0019] In response to the selection of quality control products on the visualization interface, the quality control chart of the selected quality control products and the statistical results of the quality control data distribution are displayed on the same visualization interface, wherein the quality control chart has quality control points.

[0020] In one embodiment of the present invention, the quality control method further includes:

[0021] Record the project information of the quality control project, the quality control status of each quality control item in the quality control project, and / or the quality control item information.

[0022] To achieve the above and other related objectives, the present invention provides a quality control system, the quality control system comprising:

[0023] The data acquisition module is used to acquire quality control test applications and quality control test results. The quality control test application is generated by the user through a trigger operation after determining the quality control item and at least one quality control product associated with the quality control item. The quality control test result is obtained after the quality control test is completed in response to the quality control test application.

[0024] The quality control status judgment module is used to judge the quality control test results of the at least one quality control product according to quality control rules, so as to determine the quality control status of the at least one quality control product; the quality control status includes out of control and under control;

[0025] The quality control result acquisition module is used to acquire the quality control result of the quality control item based on the quality control status of the at least one quality control product, wherein the quality control result includes whether it is under control or out of control;

[0026] The display module is used to visualize the quality control items and the corresponding quality control results on the visualization interface.

[0027] To achieve the above and other related objectives, the present invention provides an analyzer that uses the above-described quality control method or includes the above-described quality control system.

[0028] To achieve the above and other related objectives, the present invention provides a computer-readable storage medium having a computer program stored thereon, which, when executed by a computer processor, causes the computer to perform the steps of the quality control method.

[0029] As described above, the quality control method, system, analyzer, and computer storage medium of the present invention have the following beneficial effects:

[0030] A quality control method of the present invention includes: obtaining a quality control test application and quality control test results, wherein the quality control test application is generated by a user through a trigger operation after determining a quality control item and at least one quality control product associated with the quality control item; the quality control test results are obtained after completing the quality control test in response to the quality control test application; performing quality control rule judgment on the quality control test results of the at least one quality control product to determine the quality control status of the at least one quality control product; the quality control status includes out of control and under control; obtaining the quality control results of the quality control item based on the quality control status of the at least one quality control product, wherein the quality control results include under control and out of control; and visually displaying the quality control item and the corresponding quality control results on a visualization interface. Thus, the present invention displays the quality control status of a project on a project-by-project basis, indicating whether the project is under control; if out of control, it displays the specific reasons for the out-of-control status and the number of out-of-control items.

[0031] This presentation method can help users determine whether a project is under control today, thus solving the technical deficiency in existing technologies where users cannot intuitively determine whether a project is under control from the quality control overview page.

[0032] It should be understood that the above general description and the following detailed description are exemplary and explanatory only, and do not limit this application. Attached Figure Description

[0033] The accompanying drawings, which are incorporated in and form part of this specification, illustrate embodiments consistent with this application and, together with the description, serve to explain the principles of this application. It is obvious that the drawings described below are merely some embodiments of this application, and those skilled in the art can obtain other drawings based on these drawings without any inventive effort. In the drawings:

[0034] Figure 1 This is a schematic diagram of the quality control operation process shown in an exemplary embodiment of this application;

[0035] Figure 2 This is a schematic diagram illustrating the implementation environment of a quality control method according to an exemplary embodiment of this application;

[0036] Figure 3 This is a flowchart illustrating a quality control method in an exemplary embodiment of this application;

[0037] Figure 4 This is a hardware block diagram of a quality control system illustrated in an exemplary embodiment of this application;

[0038] Figure 5 A schematic diagram of the structure of an analyzer suitable for implementing embodiments of this application is shown. Detailed Implementation

[0039] The following specific examples illustrate the implementation of the present invention. Those skilled in the art can easily understand other advantages and effects of the present invention from the content disclosed in this specification. The present invention can also be implemented or applied through other different specific embodiments, and various details in this specification can also be modified or changed based on different viewpoints and applications without departing from the spirit of the present invention. It should be noted that, unless otherwise specified, the following embodiments and features described therein can be combined with each other.

[0040] It should be noted that the illustrations provided in the following embodiments are only schematic representations of the basic concept of the present invention. Therefore, the drawings only show the components related to the present invention and are not drawn according to the actual number, shape and size of the components in the actual implementation. In the actual implementation, the form, quantity and proportion of each component can be arbitrarily changed, and the layout of the components may also be more complex.

[0041] In practice, patient samples are typically tested only once before a report is issued; therefore, the accuracy and reliability of the test results are paramount. Since typical hospital laboratory departments are not standard or reference laboratories, hospitals employ quality control testing to ensure the accuracy of sample test results. Quality control testing is a crucial part of laboratory work; almost all laboratories use quality control materials for testing daily.

[0042] Quality control samples are processed samples provided by authoritative departments or reagent developers, along with the concentration ranges of various analytes in the sample. Quality control testing involves placing the quality control sample on an instrument and comparing the results to the given range to determine if the instrument is functioning correctly and if the results are reliable. If the results fall within the given range, the instrument is considered functioning correctly and the results are reliable; otherwise, the test is considered abnormal and the cause needs to be investigated. Quality control samples can be in powder or liquid form.

[0043] Actual quality control testing may use multiple control samples: one normal value control sample (whose test results are all within the reference range), and one or more outlier control samples (whose test results are all outside the reference range). Testing multiple control samples ensures that the instrument has good accuracy across all result ranges. Quality control judgment methods not only involve comparison with a given range but also combine other judgment methods. Currently, the most commonly used judgment method is the Westgard multi-rule method. This method, based on the characteristic that test results follow a normal distribution, uses the mean (X) and standard deviation (SD) of the control samples to calculate whether the test results exceed ±2SD and ±3SD, respectively, to determine whether the analytical instrument is functioning properly and whether the test results are reliable. The application of Westgard rules is quite flexible; users can select certain rules for quality control judgment as needed. Westgard rules typically require plotting LJ charts and TP charts (used only for joint quality control) to facilitate analysis and viewing of the distribution of quality control data. Westgard rules are divided into two types: individual quality control and joint quality control. Individual quality control refers to judging the quality control rules for a single quality control item. If the quality control item triggers the quality control rules, it is considered out of control. Joint quality control involves judging the quality control rules for a pair (two) quality control items simultaneously. If both quality control items trigger the quality control rules, they are considered out of control. The quality control chart for individual quality control is an LJ chart, and the quality control chart for joint quality control is a TP chart.

[0044] The quality control operation process is as follows Figure 1As shown. After setting the name, batch number, location, sample type, project parameters, and quality control rules of the quality control materials, since modifications are rarely needed, daily quality control operations are generally limited to applying for quality control testing. The process for applying for quality control testing is basically the same as that for regular sample testing: select the quality control material, select the project, and place the sample rack containing the quality control material into the sample injection port to begin testing.

[0045] Therefore, it is generally understood that laboratory physicians perform quality control tests before testing samples each day and determine whether the quality control results are normal based on the test results. Based on the above description, it is necessary to provide a quality control method.

[0046] Figure 1 This is a schematic diagram illustrating an exemplary quality control method implementation environment according to this application. Please refer to... Figure 1 The implementation environment includes an analysis device 210 and a detection device 220, which communicate with each other via a wired or wireless network. It should be noted that before quality control testing, the user first selects the quality control item to be controlled on the visualization interface of the analysis device, then identifies at least one quality control product associated with the quality control item, and then generates a quality control test application by clicking a designated button. After receiving the quality control test application, the analysis device responds to the application and generates an instruction to execute the quality control test. The user completes the quality control test using the quality control product and obtains the test results. The analysis device acquires the test results and performs quality control rule judgment on the test results of the at least one quality control product to determine its quality control status. The quality control status includes out of control and under control. Based on the quality control status of the at least one quality control product, the analysis device obtains the quality control results of the quality control item, which includes under control and out of control. The analysis device then visualizes the quality control item and its corresponding quality control results on the visualization interface. In this way, by judging and displaying the quality control status of the quality control products and the quality control results of the quality control items on the visual interface, users can, to some extent, judge whether the project is under control today, thereby solving the technical defect in the existing technology that users cannot intuitively judge whether the project is under control from the quality control overview page.

[0047] It should be understood that Figure 2 The number of analysis devices 210 and detection devices 220 shown is merely illustrative. Any number of analysis devices 210 and detection devices 220 can be used depending on actual needs.

[0048] The analysis device 210 can be any electronic device with a user input interface, including but not limited to smartphones, tablets, laptops, computers, etc. The user input interface includes but is not limited to touch screens, keyboards, physical buttons, audio pickup devices, etc.

[0049] Among them, the detection device 220 is a sample detection device used to measure the sample.

[0050] The embodiments of this application respectively propose a quality control method, a quality control system, an analyzer, and a computer-readable storage medium, which will be described in detail below.

[0051] Please see Figure 3 , Figure 3 This is a flowchart illustrating a quality control method in an exemplary embodiment of this application. This method can be applied to... Figure 2 The method is implemented in the illustrated environment and is specifically executed by the analysis device within that environment. It should be understood that the method can also be applied to other exemplary implementation environments and executed by devices in other implementation environments; this embodiment does not limit the implementation environment to which the method is applicable.

[0052] Please see Figure 3 , Figure 3 This is a flowchart illustrating an exemplary quality control method of this application. The quality control method includes at least steps S310 to S340, which are described in detail below:

[0053] Step S310: Obtain the quality control test application and the quality control test result. The quality control test application is generated by the user through a trigger operation after determining the quality control item and at least one quality control product associated with the quality control item. The quality control test result is obtained after the quality control test is completed in response to the quality control test application.

[0054] Step S320: Perform quality control rule judgment on the quality control test results of the at least one quality control product to determine the quality control status of the at least one quality control product; the quality control status includes out of control and under control;

[0055] Step S330: Obtain the quality control result of the quality control item based on the quality control status of the at least one quality control product, wherein the quality control result includes whether it is under control or out of control;

[0056] Step S340: The quality control items and the corresponding quality control results are displayed visually on the visualization interface.

[0057] It should be understood that the sequence number of each step in the above embodiments does not imply the order of execution. The execution order of each process should be determined by its function and internal logic, and should not constitute any limitation on the implementation process of the embodiments of the present invention.

[0058] Since the above quality control methods are required by users every day, the quality control items, quality control test applications, and quality control test results all refer to the current day. The above quality control methods can also be called today's quality control methods, and the quality control items are today's quality control items, including: today's quality control items and today's uncontrolled items; the quality control results are today's quality control results and today's latest quality control results.

[0059] Specifically, "projects that have undergone quality control today" refers to projects for which quality control applications have been submitted today, excluding projects for which all quality control applications and results have been deleted today, as well as projects for which quality control tests were conducted today but whose application dates do not fall within today's period.

[0060] Items not under quality control today, and all items in the instrument configuration list except those under quality control today.

[0061] Today's latest quality control results refer to the most recent and available quality control results for the specified quality control product on that day. Specifically, if the same quality control product is used for multiple quality control checks on the same day, the latest result will be used for quality control assessment.

[0062] The following will provide a detailed description of each step from S310 to S340.

[0063] In step S310, a quality control test application and a quality control test result are obtained. The quality control test application is generated by the user through a trigger operation after determining the quality control item and at least one quality control product associated with the quality control item. The quality control test result is obtained after the quality control test is completed in response to the quality control test application.

[0064] Before conducting quality control testing, the user first selects the quality control items to be controlled on the visual interface of the analytical device, then identifies at least one quality control item associated with the quality control item. After identifying the quality control item and quality control item, the user places the sample rack containing the quality control item into the testing device, and then generates a quality control test request by triggering a button set on the visual interface. The quality control test request is then sent to the analytical device. Upon receiving the quality control test request, the analytical device responds to the request and generates an instruction to execute the quality control test. The user then completes the quality control test using the quality control item and obtains the test results. It should be noted that the triggering operation can be a click operation or a touch operation; in this case, the quality control test request is generated after clicking or touching the set button with the mouse.

[0065] After quality control testing is performed on the quality control products, quality control measurement values ​​are obtained, which can be used as the quality control test results.

[0066] In step S320, the quality control test results of the at least one quality control product are judged according to quality control rules to determine the quality control status of the at least one quality control product; the quality control status includes out of control and under control.

[0067] The quality control test results of the quality control products are judged according to the quality control rules, that is, the quality control measured values ​​are compared with the quality control rules, and the quality control status of the quality control products is judged based on the comparison results.

[0068] In one embodiment, when the quality control test result triggers the quality control rule, the quality control status of the quality control product is out of control; when the quality control test result does not trigger the quality control rule, the quality control status of the quality control product is under control.

[0069] A quality control test result triggering a quality control rule can be understood as the quality control measured value falling within the numerical range indicated by the quality control rule, or the quality control measured value meeting the requirements of the quality control rule. In this case, the quality control status of the quality control product is considered out of control. A quality control test result not triggering the aforementioned quality control rule can be understood as the quality control measured value not falling within the numerical range indicated by the quality control rule, or the quality control measured value not meeting the requirements of the quality control rule. In this case, the quality control status of the quality control product is considered under control.

[0070] It should be noted that commonly used quality control rules include 1 3S 2 2s R 4S 4 1S 10 x .

[0071] 1 3S This indicates that a quality control measurement exceeds the control limit of X ± 3s. Traditionally, this is the out-of-control limit on a Levey-Jennings control chart.

[0072] 2 2s This indicates that two consecutive quality control measurements simultaneously exceed the X-2s or X+2s quality control limit;

[0073] R 4S This indicates that the difference between the high and low quality control test values ​​within the same batch exceeds 4 seconds.

[0074] 4 1S This indicates that four consecutive quality control measurements simultaneously exceed X-1s or X+1s;

[0075] 10 x This indicates that ten consecutive quality control measurements fall on the same side of the mean (X).

[0076] It should also be noted that quality control rules are set according to quality control items, and one or more quality control rules can be set for one quality control item.

[0077] In step S330, the quality control result of the quality control item is obtained based on the quality control status of the at least one quality control item, and the quality control result includes whether it is under control or out of control;

[0078] In one embodiment, obtaining the quality control result of the quality control item based on the quality control status of the at least one quality control item includes:

[0079] Obtain a first quality control sample and a second quality control sample. The first quality control sample is the same quantity as a preset quality control level, and the second quality control sample is the first quality control sample whose quality control status is under control. The quality control level is the minimum number of quality control samples required for a single quality control item. The ratio of the quantity of the second quality control sample to the quantity of the first quality control sample is compared with a preset value to obtain a comparison result, and the quality control result of the quality control item is obtained based on the comparison result.

[0080] Specifically, based on the preset quality control level, the quality control status of the quality control products with the same quality control level is selected for data processing. The ratio of the number in control to the quality control level in the selected quality control products with the same quality control level is compared with the preset value to obtain the comparison result.

[0081] In one embodiment, when the ratio of the quantity of the second quality control item to the quantity of the first quality control item is equal to or greater than the preset value, the quality control result of the quality control item is under control; when the ratio of the quantity of the second quality control item to the quantity of the first quality control item is less than the preset value, the quality control result of the quality control item is out of control.

[0082] In one embodiment, the preset value can be 100%. That is, when the number of first control items with a quality control status of "under control" is the same as the preset quality control level, the quality control result of the quality control item is "under control"; when the number of first control items with a quality control status of "under control" is less than the preset quality control level, the quality control result of the quality control item is "out of control". In other words, when the quality control status of all control items is "under control", the quality control result of the quality control item to which the multiple control items belong is "under control"; when the quality control status of any one of the multiple control items is "out of control", the quality control result of the quality control item to which the multiple control items belong is "out of control".

[0083] It should be noted that the control level is generally 1-10, preferably 3-6. Taking a control level of 6 as an example: when 6 out of multiple control items are in control, the quality control result of the quality control item is in control; when one or more of the multiple control items are out of control, the quality control result of the quality control item is out of control.

[0084] Of course, the quality control results of a quality control project include not only those under control and out of control, but also those under quality control and those not under quality control.

[0085] Out of control means that any result in the latest results of the latest quality control products applied for today used in the quality control project has triggered the quality control rules, thus indicating that the quality control project is out of control.

[0086] In Control: This means that among the latest quality control samples applied for today used in the quality control project, the latest results show that none of them are out of control. In this case, the quality control project is in control.

[0087] Quality Control in Progress: This indicates that there are no quality control aspects under control or out of control today, and only includes quality control test applications that are being applied for, tested, or not yet completed.

[0088] Not under quality control: This means that no quality control products were applied for for project quality control today, or that all quality control test applications and results for the project today have been deleted.

[0089] It should be noted that out-of-control quality control items include specified quality control results, that is, specified quality control results, obtaining the quality control product information of the corresponding quality control product, and obtaining the quality control result according to the quality control rules and fixed judgment process set for the quality control item are considered out of control situations.

[0090] Incomplete quality control items and those with deleted quality control results are not considered in determining whether an item is out of control. If the latest quality control results for multiple recently used quality control products are incomplete, the next most recent quality control result is used for judgment. If there are no other qualified quality control results on the same day but there are incomplete quality control test applications, the item is considered to be under quality control today. For example, with a quality control level of 6: Quality control item TSH (thyroid-stimulating hormone) was applied for and quality controlled today using quality control products A, B, C, D, E, F, G, and H in sequence. The six most recently used quality control products are C, D, E, F, G, and H. However, the quality control test applications for quality control products D and G are incomplete. Therefore, the latest quality control results for quality control products A, B, C, E, F, and H are used to determine whether the quality control item TSH is under control.

[0091] Today's quality control for a project only applies to quality control test applications submitted today, and not to those submitted on other days. If a quality control project is submitted on the same day but the results are received the following day, the project remains under quality control for the entire day. Even after the results are released the next day, the LJ quality control chart will still show the results as being from the current day, not the next day, and the project's status will remain "uncontrolled" on the second day. For example, if project A submitted a quality control application on June 7th but received the results on June 8th, project A remained under quality control on June 7th. On June 8th, no quality control test application was submitted; only the test from the previous day was completed. After the results are released, the LJ quality control chart will show the result date as June 7th, and project A's status on June 8th will still be "uncontrolled."

[0092] In one embodiment, when visually displaying the quality control results of the quality control item, if the quality control result of the quality control item is out of control, the first quality control status identifier of the quality control item, the number of quality control products in the quality control item whose quality control status is out of control, and the reason for the out of control are displayed in a first display mode; if the quality control result of the quality control item is under control, the second quality control status identifier is displayed in a second display mode.

[0093] The first and second display modes can be distinguished by the color and position of the displayed content; that is, the first and second display modes differ in the content displayed, the color of the content, and the display position of the content. The content can refer to quality control status indicators, including the first and second quality control status indicators. For example, the quality control status indicator for an out-of-control item is the first quality control status indicator, specifically "out of control"; while the quality control status indicator for a controllable item is the second quality control status indicator, specifically "under control". The first quality control status indicator is displayed in red, and the second quality control status indicator is displayed in green. Quality control items under control are displayed in black, and uncontrolled quality control items are displayed in gray.

[0094] The contents of quality control items that are out of control are displayed before those that are under control. The order of quality control items is: out of control, under control, under quality control, and not under quality control.

[0095] Please see Figure 1 For out-of-control quality control items, the content may also include the number of quality control products in the quality control item whose quality control status is out of control (number of out-of-control items) and the reasons for the out-of-control situation (out-of-control situation).

[0096] The number of out-of-control items refers to the number of the latest multiple quality control products applied for on the same day that are out of control for the quality control project.

[0097] The cause of loss of control refers to the set of quality control rules triggered when the latest quality control result of multiple latest quality control products applied for today used in the quality control project is out of control, including 1 3s 2 2s R 4s 4 1s 10 x If a quality control project contains multiple out-of-control quality control items, the reasons for these out-of-control items need to be displayed. Specifically, the reasons for the out-of-control items should be displayed in a preset order. For example, by selecting 1... 3s →2 2s →R 4s →4 1s →10 x The order in which they are displayed.

[0098] In one embodiment, the quality control method further includes:

[0099] Based on the quality control results of the quality control items, quality control operation prompts are generated. The quality control operation prompts are at least used to indicate quality control tests for the quality control items. The quality control operation prompts include: increasing the quantity of quality control items and modifying the quality control items.

[0100] Specifically, if the quality control level is insufficient and the requirements of the quality control items cannot be met, resulting in non-quality control results, it can be directed to increase the quantity of quality control materials used for quality control; if the quality control result is out of control and the number of out-of-control quality control materials is large, it can be directed to revise the quality control items.

[0101] In one embodiment, the quality control method further includes:

[0102] In response to the selection of quality control products on the visualization interface, the quality control chart of the selected quality control products and the statistical results of the quality control data distribution are displayed on the same visualization interface, wherein the quality control chart has quality control points.

[0103] Specifically, the quality control chart is also called the LJ (Levey-Jennings) quality control curve.

[0104] In this embodiment, the "Today's LJ Control Chart" refers to the LJ control chart of the most recent 30 days for multiple quality control products applied for today using the quality control project. Since it includes multiple quality control products, it is drawn according to the quality control product. In this embodiment, the Levey-Jennings quality control chart uses the application date as the horizontal axis and the test result (range X±3SD) as the vertical axis; it displays a maximum of 30 days of data, showing the time corresponding to each quality control point; if a quality control project is tested multiple times on the same day, the latest quality control result is displayed; quality control points with results ≥3SD are red, and quality control points with ±2SD≤x<±3SD are yellow; if fewer than 6 quality control products are tested today, only the LJ chart for the corresponding quality control product is displayed; for quality control products applied for today but for which quality control results have not yet been obtained, today's quality control results are not displayed, but the LJ chart formed by the data of the most recent 30 days can be viewed; there is no "Today's LJ Control Chart" for quality control projects that have not been tested.

[0105] Regarding the display of quality control items, if the quality control equipment tested today does not meet the quality control level, only the LJ chart of the corresponding quality control item will be displayed, and the checkboxes for other quality control items will be grayed out and unselectable. If a quality control item is tested multiple times using the same quality control item on the same day, the latest quality control result will be used for quality control judgment, and the latest quality control result will be displayed in the LJ chart.

[0106] Generally, existing quality control charts display specific quality control points, making it impossible for users to view the charts for the quality control products used today directly on the overall quality control overview page. Users must switch to the quality control chart interface and locate the specific product to view it immediately. Furthermore, when reviewing today's quality control results, users typically first check the quality control chart; only if the data or trends reflected in the chart indicate problems requiring further analysis will they specifically examine the quality control points. Therefore, the current format of quality control charts does not align well with user habits and hinders quick viewing, judgment, and analysis of quality control results. In this embodiment, quality control points are specifically distributed on the quality control curve. This eliminates the need to switch display interfaces, allowing for quick viewing of the quality control charts for products involved in quality control projects, enabling rapid analysis of any issues and improving problem-solving efficiency.

[0107] The interface allows users to select a quality control point on a quality control product, which will then display information about that point in a bubble format, including the product name (batch number), quality control date, and quality control result. If multiple quality control points overlap, information about all of them will be displayed.

[0108] The statistical results of quality control data distribution refer to the distribution of quality control data for the most recent 30 days for multiple latest quality control products applied for today, which are used in the quality control project. The data is statistically presented by quality control product and can be presented in the form of tables, bar charts, etc.

[0109] The distribution of quality control results for each quality control item is statistically analyzed by interval, with a total of 8 intervals: (-∞, -3SD], (-3SD, -2SD], (-2SD, -1SD], (-1SD, 0], (0, 1SD), [1SD, 2SD), [2SD, 3SD), [3SD, +∞). If the number of quality control items tested today is insufficient to meet the quality control level, only the data for the selected quality control items will be displayed. Quality control items applied for today but for which quality control results have not yet been obtained are not included in today's quality control data, but their data distribution over the past 30 days can be viewed.

[0110] Therefore, displaying the quality control chart and the statistical results of the quality control data distribution on the same visualization interface can provide the statistical data distribution of the quality control data without switching interfaces. While viewing the quality control chart, one can also understand the distribution of the quality control data over the past 30 days, which facilitates data analysis.

[0111] In one embodiment, the quality control method further includes:

[0112] Record the project information of the quality control project, the quality control status of each quality control item in the quality control project, and / or the quality control item information.

[0113] After completing the corresponding quality control status judgment and quality control result judgment of the quality control items, record the project information of the quality control items, the quality control status of each quality control item and / or the quality control item information, so as to be retrieved and displayed later when using the corresponding information. The quality control item information includes: quality control item name, quality control item batch number, quality control item expiration date, associated items, set mean, set standard deviation, and associated reagent batch number.

[0114] like Figure 4 As shown, this application provides a quality control system, the quality control system comprising:

[0115] The data acquisition module 410 is used to acquire quality control test applications and quality control test results. The quality control test application is generated by the user through a trigger operation after determining the quality control item and at least one quality control product associated with the quality control item. The quality control test result is obtained after the quality control test is completed in response to the quality control test application.

[0116] The quality control status judgment module 420 is used to perform quality control rule judgment on the quality control test results of the at least one quality control product to determine the quality control status of the at least one quality control product; the quality control status includes out of control and under control;

[0117] The quality control result acquisition module 430 is used to acquire the quality control result of the quality control item based on the quality control status of the at least one quality control product, wherein the quality control result includes whether it is under control or out of control;

[0118] Display module 440 is used to visualize the quality control items and the corresponding quality control results on a visualization interface.

[0119] It should be noted that the quality control system and the quality control method provided in the above embodiments belong to the same concept. The specific ways in which each module and unit performs its operation have been described in detail in the method embodiments and will not be repeated here. In practical applications, the quality control system provided in the above embodiments can be assigned to different functional modules as needed, that is, the internal structure of the device can be divided into different functional modules to complete all or part of the functions described above. This is not a limitation here.

[0120] The embodiments of the application also provide an analyzer that uses, for example Figure 3 The quality control methods shown, or including, are as follows: Figure 4 The quality control system shown is illustrated. In this embodiment, the analyzer is a chemiluminescent immunoassay analyzer, which is an immunoassay instrument that directly labels antigens or antibodies with chemiluminescent agents.

[0121] Figure 5 shows a schematic diagram of a computer system suitable for implementing the electronic device of the present application. It should be noted that... Figure 5 The computer system of the electronic device shown is merely an example and should not impose any limitation on the functionality and scope of use of the embodiments of this application.

[0122] like Figure 5 As shown, the computer system includes a Central Processing Unit (CPU), which can perform various appropriate actions and processes based on programs stored in Read-Only Memory (ROM) or loaded from storage into Random Access Memory (RAM), such as executing the methods described in the above embodiments. The RAM also stores various programs and data required for system operation. The CPU, ROM, and RAM are interconnected via a bus. Input / output (I / O) interfaces are also connected to the bus.

[0123] The following components are connected to the I / O interface: input sections including keyboards, mice, etc.; output sections including cathode ray tubes (CRTs), liquid crystal displays (LCDs), and speakers; storage sections including hard drives; and communication sections including network interface cards such as LAN (Local Area Network) cards and modems. The communication sections perform communication processing via networks such as the Internet. Drives are also connected to the I / O interface as needed. Removable media, such as disks, optical discs, magneto-optical discs, semiconductor memories, etc., are installed on the drive as needed so that computer programs read from them can be installed into the storage section as required.

[0124] Specifically, according to embodiments of this application, the processes described above with reference to the flowcharts can be implemented as computer software programs. For example, embodiments of this application include a computer program product comprising a computer program carried on a computer-readable medium, the computer program including methods for performing processes. Figure 3 The computer program for the quality control method shown is described. In such an embodiment, the computer program can be downloaded and installed from a network via a communication component, and / or installed from a removable medium. When the computer program is executed by a central processing unit (CPU), it performs the various functions defined in the system of this application.

[0125] It should be noted that the computer-readable medium shown in the embodiments of this application can be a computer-readable signal medium or a computer-readable storage medium, or any combination of the two. A computer-readable storage medium can be, for example, an electrical, magnetic, optical, electromagnetic, infrared, or semiconductor system, apparatus, or device, or any combination thereof. More specific examples of a computer-readable storage medium may include, but are not limited to: an electrical connection having one or more wires, a portable computer disk, a hard disk, random access memory (RAM), read-only memory (ROM), erasable programmable read-only memory (EPROM), flash memory, optical fiber, portable compact disc read-only memory (CD-ROM), optical storage device, magnetic storage device, or any suitable combination thereof. In this application, a computer-readable signal medium may include a data signal propagated in baseband or as part of a carrier wave, carrying a computer-readable computer program. Such propagated data signals can take various forms, including but not limited to electromagnetic signals, optical signals, or any suitable combination thereof. Computer-readable signal media can also be any computer-readable medium other than computer-readable storage media, which can send, propagate, or transmit a program for use by or in connection with an instruction execution system, apparatus, or device. The computer program contained on the computer-readable medium can be transmitted using any suitable medium, including but not limited to wireless, wired, etc., or any suitable combination thereof.

[0126] The flowcharts and block diagrams in the accompanying drawings illustrate the architecture, functionality, and operation of possible implementations of systems, methods, and computer program products according to various embodiments of this application. Each block in a flowchart or block diagram may represent a module, segment, or portion of code, which contains one or more executable instructions for implementing a specified logical function. It should also be noted that in some alternative implementations, the functions indicated in the blocks may occur in a different order than those indicated in the drawings. For example, two consecutively indicated blocks may actually be executed substantially in parallel, and they may sometimes be executed in reverse order, depending on the functions involved. It should also be noted that each block in a block diagram or flowchart, and combinations of blocks in a block diagram or flowchart, can be implemented using a dedicated hardware-based system that performs the specified function or operation.

[0127] Alternatively, it can be achieved using a combination of dedicated hardware and computer instructions.

[0128] The units described in the embodiments of this application can be implemented in software or hardware, and the described units can also be located in a processor. The names of these units do not necessarily limit the specific unit itself.

[0129] Another aspect of this application provides a computer-readable storage medium storing a computer program thereon, which, when executed by a computer's processor, causes the computer to perform the quality control method as described above. This computer-readable storage medium may be included in the electronic device described in the above embodiments, or it may exist independently and not assembled into the electronic device.

[0130] The above embodiments are merely illustrative of the principles and effects of the present invention and are not intended to limit the invention. Any person skilled in the art can modify or alter the above embodiments without departing from the spirit and scope of the present invention. Therefore, all equivalent modifications or alterations made by those skilled in the art without departing from the spirit and technical concept disclosed in the present invention should still be covered by the claims of the present invention.

Claims

1. A quality control method, characterized in that, The quality control method includes: Obtain quality control test requests and quality control test results. The quality control test request is generated by the user through a trigger operation after determining the quality control item and at least one quality control product associated with the quality control item. The quality control test result is obtained after the quality control test is completed in response to the quality control test request. The quality control test results of the at least one quality control item are used to determine the quality control status of the at least one quality control item by applying quality control rules; the quality control status includes out of control and under control. The quality control results of the quality control items are obtained based on the quality control status of the at least one quality control item, and the quality control results include whether the items are under control or out of control. The quality control items and their corresponding quality control results are displayed visually in the visualization interface. When visualizing the quality control results of the quality control items, if the quality control result is out of control, the first quality control status identifier of the quality control item, the number of quality control products with an out-of-control status, and the reason for the out-of-control status are displayed in the first display mode; if the quality control result is in control, the second quality control status identifier is displayed in the second display mode.

2. The quality control method according to claim 1, characterized in that, The process of obtaining the quality control result of the quality control item based on the quality control status of the at least one quality control item includes: Obtain a first quality control sample and a second quality control sample. The first quality control sample is the same quantity of quality control samples as the preset quality control level, and the second quality control sample is the first quality control sample whose quality control status is under control. The quality control level is the minimum number of quality control samples required for a single quality control item. The ratio of the quantity of the second quality control product to the quantity of the first quality control product is compared with a preset value to obtain a comparison result, and the quality control result of the quality control item is obtained based on the comparison result.

3. The quality control method according to claim 2, characterized in that, When the ratio of the quantity of the second quality control product to the quantity of the first quality control product is equal to or greater than the preset value, the quality control result is under control; when the ratio of the quantity of the second quality control product to the quantity of the first quality control product is less than the preset value, the quality control result is out of control.

4. The quality control method according to claim 1, characterized in that, When the quality control test result triggers the quality control rule, the quality control status of the quality control product is out of control; when the quality control test result does not trigger the quality control rule, the quality control status of the quality control product is under control.

5. The quality control method according to claim 1, characterized in that, The quality control method also includes: Based on the quality control results of the quality control items, quality control operation prompts are generated. The quality control operation prompts are at least used to indicate quality control tests for the quality control items. The quality control operation prompts include: increasing the quantity of quality control items and modifying the quality control items.

6. The quality control method according to claim 1, characterized in that, The quality control method also includes: In response to the selection of quality control products on the visualization interface, the quality control chart of the selected quality control products and the statistical results of the quality control data distribution are displayed on the same visualization interface, wherein the quality control chart has quality control points.

7. The quality control method according to claim 1, characterized in that, The quality control method also includes: Record the project information of the quality control project, the quality control status of each quality control item in the quality control project, and / or the quality control item information.

8. A quality control system, characterized in that, The quality control system includes: The data acquisition module is used to acquire quality control test applications and quality control test results. The quality control test application is generated by the user through a trigger operation after determining the quality control item and at least one quality control product associated with the quality control item. The quality control test result is obtained after the quality control test is completed in response to the quality control test application. The quality control status judgment module is used to judge the quality control test results of the at least one quality control product according to quality control rules, so as to determine the quality control status of the at least one quality control product; the quality control status includes out of control and under control; The quality control result acquisition module is used to acquire the quality control result of the quality control item based on the quality control status of the at least one quality control product, wherein the quality control result includes whether it is under control or out of control; The display module is used to visualize the quality control items and the corresponding quality control results on the visualization interface; When visualizing the quality control results of the quality control items, if the quality control result is out of control, the first quality control status identifier of the quality control item, the number of quality control products with an out-of-control status, and the reason for the out-of-control status are displayed in the first display mode; if the quality control result is in control, the second quality control status identifier is displayed in the second display mode.

9. An analyzer, characterized in that, The quality control method described in any one of claims 1-7 is used, or the quality control system described in claim 8 is included.

10. A computer-readable storage medium, characterized in that, It stores a computer program that, when executed by the computer's processor, causes the computer to perform the steps of the quality control method as described in any one of claims 1 to 7.

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