Medical laboratory quality index management system and equipment based on ISO15189 standard and storage medium

By designing a medical laboratory quality index management system based on ISO15189 standard, and automatically processing quality index data and generating files, the problems of inaccurate data and irregular file caused by manual processing in the existing technology have been solved, and resource conservation and data accuracy have been improved.

CN119918986APending Publication Date: 2025-05-02GUANGZHOU FANGXIN MEDICAL TECH CO LTD
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Patent Information

Application Number
CN202411811229.3
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2024-12-10
Publication Date
2025-05-02

AI Technical Summary

Technical Problem

In medical laboratories, during the quality index management and review process recognized by ISO15189, the existing technology relies on manual processing, resulting in inaccurate data, large errors, irregular documents, and a large amount of human resources.

Method used

Design a medical laboratory quality index management system based on ISO15189 standard, including quality index file generation module, post-inspection process data processing module, user feedback module and complaint management module to realize the automated processing of quality index data and the automated generation of files.

Benefits of technology

Through automated processing, human resources are saved, data accuracy is improved, documents comply with review requirements and document management specifications, and management review work is supported.

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Abstract

The invention discloses a medical laboratory quality index management system based on an ISO15189 standard, electronic equipment and a computer readable storage medium. The system comprises a quality index file generation module, a post-inspection process data processing module, a user feedback module, a complaint management module and the like. The method is used for realizing data processing of related quality index management review and automatic processing of a file making process, and can effectively help a laboratory to carry out quality index management, and the automatically generated file can be used as a review material to support management review work; by replacing manual processing, human resources can be effectively saved, data accuracy is improved, and it is guaranteed that the files meet review requirements and file management specifications.
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Description

Technical Field

[0001] The present invention relates to the field of data processing technology, and in particular to a medical laboratory quality indicator management system, electronic equipment and computer-readable storage medium based on ISO15189 standard. Background Art

[0002] With the continuous advancement of medical technology and the continuous improvement of medical quality, ISO15189 accreditation plays an important role in the field of medical laboratories. More and more medical laboratories are actively applying for and passing ISO15189 accreditation to continuously improve their quality management level and technical capabilities, thereby enhancing patient trust and satisfaction. However, for medical laboratories, ISO15189 accreditation is undoubtedly a huge and complex system project. Whether it is the first application for accreditation or a medical laboratory that has already been accredited, great efforts are required in the early preparation and the operation and maintenance of the management system in the later stage.

[0003] Laboratory quality indicator management review is an important part of the operation of the ISO15189 system, which involves data acquisition, recording and calculation in multiple aspects, as well as the preparation of monthly / annual quality indicator documents. In the process of laboratory quality indicator management, most of the work is handled manually by laboratory personnel, which not only requires a lot of human resources, but also easily leads to irregular and inadequate execution of work procedures, such as inaccurate data, large errors, and irregular documents. Summary of the invention

[0004] In order to overcome the shortcomings of the prior art, the purpose of the present invention is to provide a medical laboratory quality indicator management system, electronic equipment and computer-readable storage medium based on the ISO15189 standard, which is used to realize the automation of data processing and document preparation process related to quality indicator management review, which can effectively help laboratories to manage quality indicators, and the automatically generated documents can be used as review materials to support management review work; by replacing manual processing, it can effectively save human resources, improve data accuracy, and ensure that the documents meet the review requirements and document management specifications.

[0005] The medical laboratory quality index management system based on ISO15189 standard of the present invention is implemented by the following technical solutions: A medical laboratory quality indicator management system based on ISO15189 standard, including: The quality indicator file generation module is used to fill in the preset monthly quality indicator statistical table template according to the post-inspection process quality indicator data, user satisfaction rate data and complaint handling rate data to generate a monthly quality indicator completion status statistical table, and draw an annual quality indicator statistical analysis chart. The annual quality indicator statistical analysis chart visually presents the quality indicator completion status of each month of the year; The post-test process data processing module is used to connect to the pathology full-process management system to obtain the post-test process quality indicator data and import the post-test process quality indicator data into the quality indicator file generation module; The user feedback module is used to provide users with satisfaction questionnaires and receive satisfaction questionnaires from users, calculate the user satisfaction rate according to a preset ratio calculation formula, and import the user satisfaction rate data into the quality indicator file generation module; The complaint management module is used to provide users with complaint form templates and receive complaint application forms for user feedback. It calculates the complaint handling rate based on the handling of complaint applications and the preset ratio calculation formula, and imports the complaint handling rate data into the quality indicator file generation module.

[0006] Furthermore, the post-test process quality indicator data includes ratio data and sample data used to calculate the ratio data, and the ratio data includes the standardized specimen fixation rate, the excellent pathological film preparation rate, the conventional diagnosis quality control compliance rate, the intraoperative rapid diagnosis and paraffin section diagnosis compliance rate, and the timely reporting rate; The excellent rate of pathological film preparation includes one or more of the excellent rate of HE sections and the excellent rate of immunohistochemical staining sections; The timeliness rate of reporting includes one or more of the timeliness rate of intraoperative rapid pathological diagnosis, the timeliness rate of cytopathological diagnosis and the timeliness rate of histopathological diagnosis.

[0007] Further, the complaint handling rate data includes the complaint handling rate and sample data used to calculate the complaint handling rate; The user satisfaction rate data includes the user satisfaction rate and sample data for calculating the user satisfaction rate. The user feedback module is also used to determine whether the user is a satisfied user based on the user's satisfaction survey questionnaire and a preset satisfaction calculation formula.

[0008] Furthermore, the annual quality indicator statistical analysis chart includes statistical analysis charts of various quality indicators, wherein the statistical analysis chart of each quality indicator is in the form of a bar chart, a line chart, a bar chart or a radar chart.

[0009] Furthermore, the complaint management module includes a complaint application submodule, a complaint handling submodule and a complaint statistics analysis module; The complaint application submodule is used to provide users with complaint form templates and receive complaint application forms with user feedback; The complaint handling submodule is used to distribute complaint application forms and record the handling status of complaint applications; The complaint statistics analysis module is used to calculate the complaint handling rate based on the handling status of the complaint application and a preset ratio calculation formula, and import the complaint handling rate data into the quality indicator file generation module.

[0010] Further, in the post-inspection process data processing module, the post-inspection process quality index data includes monthly data and real-time dynamic data of the current month, the monthly data includes monthly ratio data and monthly sample data for calculating the monthly ratio data, and the real-time dynamic data of the current month includes real-time ratio data of the current month and real-time sample data of the current month for calculating the real-time ratio data of the current month; In the user feedback module, the user satisfaction rate data includes monthly data and real-time dynamic data of the current month, the monthly data includes monthly ratio data and monthly sample data used to calculate the monthly ratio data, and the real-time dynamic data of the current month includes the real-time ratio data of the current month and the real-time sample data of the current month used to calculate the real-time ratio data of the current month; In the complaint management module, the complaint handling rate data includes monthly data and real-time dynamic data of the current month, the monthly data includes monthly ratio data and monthly sample data used to calculate the monthly ratio data, and the real-time dynamic data of the current month includes the real-time ratio data of the current month and the real-time sample data of the current month used to calculate the real-time ratio data of the current month; The quality indicator file generation module is also used to output the real-time quality indicator data of the month, which includes the real-time dynamic data of the post-inspection process quality indicator data, the real-time dynamic data of the user satisfaction rate data and the real-time dynamic data of the complaint handling rate data.

[0011] Furthermore, the quality indicator file generation module is also used to generate an annual quality indicator statistical analysis text, and fill the annual quality indicator statistical analysis chart and the annual statistical analysis text into a preset report document template to generate an annual quality indicator report document; The annual quality indicator statistical analysis text includes a text describing the development trends of each quality indicator, a text suggesting plans for the coming year for each quality indicator, and an evaluation text on whether the laboratory quality indicators meet the requirements of the ISO15189 operating system.

[0012] Furthermore, the medical laboratory quality indicator management system also includes a laboratory management review module; The quality indicator file generation module is also used to import the monthly quality indicator completion status statistical table and / or the annual quality indicator statistical analysis chart into the laboratory management review module; The laboratory management review module is used for archiving and calling monthly quality indicator completion statistical tables and / or annual quality indicator statistical analysis charts.

[0013] The electronic device of the present invention is implemented by the following technical solution: An electronic device comprises a processor and a memory storing a computer program. When the processor executes the computer program, the medical laboratory quality indicator management system based on the ISO15189 standard as described above is implemented.

[0014] The computer-readable storage medium of the present invention is implemented by the following technical solution: A computer-readable storage medium stores a computer program, which, when executed by a processor, implements the medical laboratory quality indicator management system based on the ISO15189 standard as described above.

[0015] Compared with the prior art, the present invention has the following beneficial effects: The medical laboratory quality indicator management system, electronic device and computer-readable storage medium based on the ISO15189 standard provided by the present invention are used to realize the automation of data processing and document preparation process related to quality indicator management review, which can effectively help laboratories to manage quality indicators. The automatically generated documents can be used as review materials to support management review work; by replacing manual processing, it can effectively save human resources, improve data accuracy, and ensure that the documents meet the review requirements and document management specifications. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Figure 1 This is a schematic diagram of a medical laboratory quality index management system based on the ISO15189 standard according to a preferred embodiment of the present invention; Figure 2 This is an example of a template for a monthly quality indicator statistics table; Figure 3 Examples of statistical analysis charts for annual quality indicators; Figure 4 FIG. 1 is a schematic structural diagram of an electronic device according to a preferred embodiment of the present invention. DETAILED DESCRIPTION

[0017] The present invention is further described below in conjunction with the accompanying drawings and specific implementation methods. It should be noted that, under the premise of no conflict, the various embodiments or technical features described below can be arbitrarily combined to form a new embodiment.

[0018] The preferred embodiment of the present invention provides a medical laboratory quality indicator management system, electronic equipment and computer-readable storage medium based on the ISO15189 standard.

[0019] refer to Figure 1 The medical laboratory quality indicator management system based on the ISO15189 standard of this embodiment includes a quality indicator file generation module, a post-test process data processing module, a user feedback module, a complaint management module and a laboratory management review module.

[0020] The quality indicator file generation module is used to fill in the preset monthly quality indicator statistical table template according to the post-inspection process quality indicator data, user satisfaction rate data and complaint handling rate data to generate a monthly quality indicator completion status statistical table; and the quality indicator file generation module is also used to draw an annual quality indicator statistical analysis chart based on the post-inspection process quality indicator data, user satisfaction rate data and complaint handling rate data. The annual quality indicator statistical analysis chart visually presents the quality indicator completion status of each month of the year. Among them, the monthly quality indicator completion status statistical table is a file that must be archived in the quality indicator management review and needs to comply with the relevant requirements of the ISO15189 standard. Figure 2 The monthly quality indicator statistics table template shown in the figure, in the quality indicator management review, the number of quality indicators is relatively large (this embodiment takes 10 as an example, and some laboratories may require more). If the documents are made manually, it is easy to make mistakes or the documents do not meet the specifications. In order to ensure the accuracy and standardization of the file data, this embodiment provides a monthly quality indicator statistics table template. The quality indicator file generation module can automatically generate a standardized monthly quality indicator completion status statistical table by filling in the relevant quality indicator data.

[0021] The post-test process data processing module is used to connect to the pathology full-process management system to obtain the post-test process quality indicator data (including 8 quality indicators of laboratory quality indicator management review, reference Figure 21-8 in the data), and import the post-inspection process quality indicator data into the quality indicator file generation module. Among them, the post-inspection process quality indicator data includes ratio data and sample data for calculating ratio data. For example, the sample data includes the number of qualified samples and the total number of samples, and the calculation formula of the ratio data is: ratio data = (number of qualified samples / total number of samples) × 100%. Among them, the ratio data includes the standardized fixation rate of specimens, the excellent film rate of pathological preparation, the compliance rate of conventional diagnosis quality control, the compliance rate of intraoperative rapid diagnosis and paraffin section diagnosis, and the timely reporting rate; the excellent film rate of pathological preparation includes one or more of the excellent rate of HE sections and the excellent rate of immunohistochemical staining sections; the timely reporting rate includes one or more of the timely rate of intraoperative rapid pathological diagnosis, the timely rate of cytopathology diagnosis and the timely rate of histopathology diagnosis. Here, a more detailed example of ratio data and sample data for calculating ratio data is given; for example, HE slice quality rate and sample data for calculating HE slice quality rate, the sample data for calculating HE slice quality rate includes the number of HE good slices and the total number of HE slices, and the calculation formula of HE slice quality rate is: HE slice quality rate = (number of HE good slices / total number of HE slices) × 100%. The eight quality indicators related to the post-inspection process can all use similar calculation formulas. If the connected pathology full-process management system does not provide ratio data, it can be calculated according to the ratio data calculation formula provided in this embodiment. If the connected pathology full-process management system itself can provide the required ratio data, no calculation is required.

[0022] It should be noted that the pathology full-process management system is an information management system that must be configured in the pathology laboratory. It includes full-process records of each link from the specimen entering the pathology medical laboratory (i.e. receiving the specimen), to processing the specimen, to finally issuing a report based on the specimen situation; the pathology full-process management systems configured by different laboratories may differ in function.

[0023] The user feedback module is used to provide users with satisfaction questionnaires and receive user feedback satisfaction questionnaires, and calculate the user satisfaction rate according to the preset ratio calculation formula (the 9th quality indicator of the laboratory quality indicator management review, refer to Figure 29), import the user satisfaction rate data into the quality indicator file generation module. Wherein, the satisfaction survey questionnaire can be an online questionnaire provided by the browser webpage or APP interface, or a file downloaded offline. The user uploads the questionnaire after filling it out. Wherein, the user satisfaction rate data includes the user satisfaction rate and the sample data used to calculate the user satisfaction rate; for example, the sample data used to calculate the user satisfaction rate includes the number of satisfied users and the total number of users, and the user satisfaction rate calculation formula is: user satisfaction rate = (number of satisfied users / total number of users) × 100%. Wherein, the user feedback module is also used to determine whether the user is a satisfied user based on the user's satisfaction survey questionnaire and the preset satisfaction calculation formula; for example, the user feedback module can calculate the score of the user's satisfaction survey questionnaire, and when the valid score reaches a certain value, the user is determined to be a satisfied user. The satisfaction survey questionnaire is used to investigate the user's satisfaction with the laboratory inspection business (not this system, please do not confuse). The satisfaction survey still needs to comply with the relevant requirements of the ISO15189 standard and contains a large number of statistical calculations. Therefore, if it is handled manually, it is easy to have irregular questionnaires or inaccurate survey data.

[0024] The complaint management module is used to provide users with complaint form templates and receive complaint application forms for user feedback. The complaint handling rate is calculated based on the handling status of the complaint application and the preset ratio calculation formula (the 10th quality indicator of the laboratory quality indicator management review, refer to Figure 2 Serial number 10), import the complaint handling rate data into the quality indicator file generation module. The complaint form template can be an online fill-in form provided by the browser webpage or APP interface, or a file downloaded offline. The user fills in the form and then uploads the complaint application form. The complaint handling rate data includes the complaint handling rate and sample data for calculating the complaint handling rate; for example, the sample data for calculating the complaint handling rate includes the number of complaints handled and the total number of complaint applications. The calculation formula for the complaint handling rate is: Complaint handling rate = (number of complaints handled / total number of complaint applications) × 100%. Specifically, the complaint management module includes a complaint application sub-module (mainly used for interaction with users), a complaint handling sub-module (mainly used for interaction with laboratory personnel) and a complaint statistical analysis module; the complaint application sub-module is used to provide users with complaint form templates and receive complaint application forms for user feedback; the complaint handling sub-module is used to distribute complaint application forms (to corresponding laboratory personnel) and record the handling status of complaint applications (for example, unhandled, in progress, handled, etc.); the complaint statistical analysis module is used to calculate the complaint handling rate based on the handling status of the complaint application and the preset ratio calculation formula, and import the complaint handling rate data into the quality indicator file generation module.

[0025] Laboratory quality index management review is an important part of ISO15189 system operation, which involves the acquisition and processing of 10 quality index data. These quality index data need to be acquired from multiple data sources. The data acquisition process is already very complicated and cumbersome, coupled with complex data processing and file production processes, which often leads to laboratory personnel encountering unclear directions and situations where they have no idea where to start. Therefore, the system of this embodiment docks the data source of the pathology full-process management system through the post-inspection process data processing module, and the user feedback module and the complaint management module themselves can become data sources, thus realizing the automation and real-time acquisition of quality index data. In the past, data was collected manually on a monthly basis, which not only consumed a lot of human resources, but also was prone to errors and omissions in the data, and only static data could be obtained, which could not reflect the current situation of the medical laboratory in real time, and thus could not monitor and adjust laboratory activities in time.

[0026] In the post-inspection process data processing module, the post-inspection process quality index data includes monthly data and real-time dynamic data for the current month. Monthly data includes monthly ratio data and monthly sample data used to calculate monthly ratio data; for example, the monthly sample data used to calculate monthly ratio data includes the number of monthly qualified samples and the total number of monthly samples, then the calculation formula for monthly ratio data is: monthly ratio data = (number of monthly qualified samples / total number of monthly samples) × 100%. Real-time dynamic data for the current month includes real-time ratio data for the current month and real-time sample data for the current month used to calculate real-time ratio data for the current month; for example, the real-time sample data for the current month used to calculate real-time ratio data for the current month includes the number of real-time cumulative qualified samples for the current month and the total number of real-time cumulative samples for the current month, then the real-time ratio data for the current month = (the number of real-time cumulative qualified samples for the current month / the total number of real-time cumulative samples for the current month) × 100%.

[0027] In the user feedback module, the user satisfaction rate data includes monthly data and real-time dynamic data for the current month. The monthly data includes monthly ratio data and monthly sample data for calculating the monthly ratio data. The real-time dynamic data for the current month includes real-time ratio data for the current month and real-time sample data for the current month for calculating the real-time ratio data for the current month.

[0028] In the complaint management module, the complaint handling rate data includes monthly data and real-time dynamic data for the current month. The monthly data includes monthly ratio data and monthly sample data for calculating the monthly ratio data. The real-time dynamic data for the current month includes real-time ratio data for the current month and real-time sample data for the current month for calculating the real-time ratio data for the current month.

[0029] The quality index file generation module is also used to output the real-time quality index data of the month, which includes the real-time dynamic data of the post-test process quality index data, the real-time dynamic data of the user satisfaction rate data and the real-time dynamic data of the complaint handling rate data. By outputting these real-time dynamic data, the current status of the medical laboratory can be reflected in real time, which helps to monitor and adjust the laboratory activities in a timely manner.

[0030] In the medical laboratory quality indicator management system of this embodiment, the annual quality indicator statistical analysis chart includes statistical analysis charts of various quality indicators, wherein the statistical analysis chart of each quality indicator is in the form of a bar chart, a line chart, a bar chart or a radar chart; Figure 3 In this embodiment, the quality indicator data is visualized in the form of a bar graph. Figure 3 In the example, due to space limitations, each quality indicator only shows monthly ratio data. In fact, there can also be monthly sample data, such as the specific number of monthly qualified samples and the total number of monthly samples written near the monthly ratio data. The annual quality indicator statistical analysis chart is used to visualize the completion of quality indicators for each month of the year. It can intuitively display the specific completion status and development trend of each quality indicator, provide analytical materials for management review for the laboratory, and help adjust the operation of the laboratory quality management system.

[0031] The medical laboratory quality indicator management system of this embodiment can help the development and construction of the laboratory quality management system from two aspects: daily monitoring and annual management review, through monthly real-time dynamic data and annual quality indicator statistical analysis charts, thereby greatly improving the data reuse rate.

[0032] The quality indicator file generation module is also used to generate an annual quality indicator statistical analysis text, and fill the annual quality indicator statistical analysis chart and annual statistical analysis text into a preset report document template to generate an annual quality indicator report document; the annual quality indicator statistical analysis text includes a description text of the development trend of each quality indicator, a text of the next year's planning suggestion for each quality indicator, and an evaluation text on whether the laboratory quality indicator meets the requirements of the ISO15189 operating system. By generating a report document template, it provides laboratory managers with ideas for planning and building a laboratory quality management system.

[0033] The medical laboratory quality indicator management system of this embodiment also includes a laboratory management review module; the quality indicator file generation module is also used to import monthly quality indicator completion statistical tables and / or annual quality indicator statistical analysis charts into the laboratory management review module; the laboratory management review module is used to archive and call monthly quality indicator completion statistical tables and / or annual quality indicator statistical analysis charts.

[0034] To sum up, the medical laboratory quality indicator management system based on the ISO15189 standard in the preferred embodiment of the present invention can realize the automation of data processing and document preparation process related to quality indicator management review, and can effectively help laboratories to manage quality indicators. The automatically generated documents can be used as review materials to support management review work; by replacing manual processing, it can effectively save human resources, improve data accuracy, and ensure that documents meet review requirements and document management specifications.

[0035] refer to Figure 4 The electronic device of the preferred embodiment of the present invention includes a processor 401 and a memory 402 storing a computer program. When the processor 401 executes the computer program, the medical laboratory quality index management system based on the ISO15189 standard as described in this embodiment is implemented. The processor 401, the memory 402, and the communication interface 403 all communicate with each other through a communication bus 404.

[0036] In the electronic device of this embodiment, the processor 401 may be a central processing unit (CPU), a specific application integrated circuit, a digital signal processor, a field programmable gate array or other programmable logic device, and the processor 401 may be a microprocessor or any conventional processor, etc. The processor 401 may call a program stored in the memory 402.

[0037] In the electronic device of this embodiment, the memory 402 is used to store one or more programs, and the program may include a program code, and the program code includes a computer operation instruction. The memory 402 may store a program for implementing the corresponding function of the above-mentioned system. In a possible implementation, the memory 402 may include a program storage area and a data storage area, wherein the program storage area may store an operating system, and a computer program required for at least one system function, etc.; the data storage area may store data created during use. In addition, the memory 402 may include a read-only memory and a random access memory, and provide instructions and data to the processor. A part of the memory may also include NVRAM. The memory stores an operating system and operation instructions, executable modules or data structures, or a subset thereof, or an extended set thereof, wherein the operation instructions may include various operation instructions for implementing various operations. The operating system may include various system programs for implementing various basic tasks and processing hardware-based tasks.

[0038] In the electronic device of this embodiment, the communication interface 403 may be an interface of a communication module, which is used to connect to other devices or systems. Figure 4The structure shown does not constitute a limitation on the electronic device in the embodiment of the present invention. In actual applications, the electronic device may include Figure 4 More or fewer components than shown, or combinations of certain components.

[0039] The electronic device of the preferred embodiment of the present invention is used to realize the automation of data processing and document preparation process related to quality indicator management review, which can effectively help laboratories to manage quality indicators. The automatically generated documents can be used as review materials to support management review work; by replacing manual processing, it can effectively save human resources, improve data accuracy, and ensure that documents meet review requirements and document management specifications.

[0040] The computer-readable storage medium of the preferred embodiment of the present invention stores a computer program thereon, and when the computer program is executed by a processor, the medical laboratory quality index management system based on the ISO15189 standard as described in the present embodiment is implemented. Wherein, the computer-readable storage medium can be a tangible medium, which can contain or store a computer program for use by an instruction execution system, device or equipment or used in combination with an instruction execution system, device or equipment. The computer-readable storage medium can include but is not limited to electronic, magnetic, optical, electromagnetic, infrared, or semiconductor systems, devices or equipment, or any suitable combination of the above. Alternatively, the computer-readable storage medium can be a machine-readable signal medium. A more specific example of a computer-readable storage medium can include an electrical connection based on one or more lines, a portable computer disk, a hard disk, a random access memory (RAM), a read-only memory (ROM), an erasable programmable read-only memory (EPROM or flash memory), an optical fiber, a portable compact disk read-only memory (CD-ROM), an optical storage device, a magnetic storage device, or any suitable combination of the above.

[0041] The computer-readable storage medium of the preferred embodiment of the present invention is used to realize the automation of data processing and document preparation process related to quality indicator management review, which can effectively help laboratories to manage quality indicators. The automatically generated documents can be used as review materials to support management review work; by replacing manual processing, it can effectively save human resources, improve data accuracy, and ensure that documents meet review requirements and document management specifications.

[0042] The above-mentioned embodiments are only preferred embodiments of the present invention and cannot be used to limit the scope of protection of the present invention. Any non-substantial changes and substitutions made by technicians in this field on the basis of the present invention shall fall within the scope of protection required by the present invention.

Claims

1. A medical laboratory quality index management system based on ISO15189 standard, characterized in that: include: The quality indicator file generation module is used to fill in the preset monthly quality indicator statistical table template according to the post-inspection process quality indicator data, user satisfaction rate data and complaint handling rate data to generate a monthly quality indicator completion status statistical table, and draw an annual quality indicator statistical analysis chart. The annual quality indicator statistical analysis chart visually presents the quality indicator completion status of each month of the year; The post-test process data processing module is used to connect to the pathology full-process management system to obtain the post-test process quality indicator data and import the post-test process quality indicator data into the quality indicator file generation module; The user feedback module is used to provide users with satisfaction questionnaires and receive satisfaction questionnaires from users, calculate the user satisfaction rate according to a preset ratio calculation formula, and import the user satisfaction rate data into the quality indicator file generation module; The complaint management module is used to provide users with complaint form templates and receive complaint application forms for user feedback. It calculates the complaint handling rate based on the handling of complaint applications and the preset ratio calculation formula, and imports the complaint handling rate data into the quality indicator file generation module.

2. The medical laboratory quality index management system according to claim 1, characterized in that: The post-test process quality indicator data includes ratio data and sample data used to calculate ratio data, and the ratio data includes the standardized specimen fixation rate, the excellent pathological film preparation rate, the conventional diagnosis quality control compliance rate, the intraoperative rapid diagnosis and paraffin section diagnosis compliance rate, and the timely reporting rate; The excellent rate of pathological film preparation includes one or more of the excellent rate of HE sections and the excellent rate of immunohistochemical staining sections; The timeliness rate of reporting includes one or more of the timeliness rate of intraoperative rapid pathological diagnosis, the timeliness rate of cytopathological diagnosis and the timeliness rate of histopathological diagnosis.

3. The medical laboratory quality index management system according to claim 1, characterized in that: The complaint handling rate data includes the complaint handling rate and sample data used to calculate the complaint handling rate; The user satisfaction rate data includes the user satisfaction rate and sample data for calculating the user satisfaction rate. The user feedback module is also used to determine whether the user is a satisfied user based on the user's satisfaction survey questionnaire and a preset satisfaction calculation formula.

4. The medical laboratory quality index management system according to claim 1, characterized in that: The annual quality indicator statistical analysis chart includes statistical analysis charts of various quality indicators, wherein the statistical analysis chart of each quality indicator is in the form of a column chart, a line chart, a bar chart or a radar chart.

5. The medical laboratory quality index management system according to claim 1, characterized in that: The complaint management module includes a complaint application submodule, a complaint processing submodule and a complaint statistics analysis module; The complaint application submodule is used to provide users with complaint form templates and receive complaint application forms with user feedback; The complaint handling submodule is used to distribute complaint application forms and record the handling status of complaint applications; The complaint statistics analysis module is used to calculate the complaint handling rate based on the handling status of the complaint application and a preset ratio calculation formula, and import the complaint handling rate data into the quality indicator file generation module.

6. The medical laboratory quality index management system according to claim 1, characterized in that: In the post-inspection process data processing module, the post-inspection process quality index data includes monthly data and real-time dynamic data of the current month, the monthly data includes monthly ratio data and monthly sample data for calculating the monthly ratio data, and the real-time dynamic data of the current month includes real-time ratio data of the current month and real-time sample data of the current month for calculating the real-time ratio data of the current month; In the user feedback module, the user satisfaction rate data includes monthly data and real-time dynamic data of the current month, the monthly data includes monthly ratio data and monthly sample data used to calculate the monthly ratio data, and the real-time dynamic data of the current month includes the real-time ratio data of the current month and the real-time sample data of the current month used to calculate the real-time ratio data of the current month; In the complaint management module, the complaint handling rate data includes monthly data and real-time dynamic data of the current month, the monthly data includes monthly ratio data and monthly sample data used to calculate the monthly ratio data, and the real-time dynamic data of the current month includes the real-time ratio data of the current month and the real-time sample data of the current month used to calculate the real-time ratio data of the current month; The quality indicator file generation module is also used to output the real-time quality indicator data of the month, which includes the real-time dynamic data of the post-inspection process quality indicator data, the real-time dynamic data of the user satisfaction rate data and the real-time dynamic data of the complaint handling rate data.

7. The medical laboratory quality index management system according to claim 1, characterized in that: The quality indicator file generation module is also used to generate an annual quality indicator statistical analysis text, and fill the annual quality indicator statistical analysis chart and the annual statistical analysis text into a preset report document template to generate an annual quality indicator report document; The annual quality indicator statistical analysis text includes a text describing the development trends of each quality indicator, a text suggesting plans for the coming year for each quality indicator, and an evaluation text on whether the laboratory quality indicators meet the requirements of the ISO15189 operating system.

8. The medical laboratory quality index management system according to claim 1, characterized in that: The medical laboratory quality indicator management system also includes a laboratory management review module; The quality indicator file generation module is also used to import the monthly quality indicator completion status statistical table and / or the annual quality indicator statistical analysis chart into the laboratory management review module; The laboratory management review module is used for archiving and calling monthly quality indicator completion statistical tables and / or annual quality indicator statistical analysis charts.

9. An electronic device, characterized in that: It comprises a processor and a memory storing a computer program. When the processor executes the computer program, it implements the medical laboratory quality indicator management system based on the ISO15189 standard as described in any one of claims 1 to 8.

10. A computer-readable storage medium having a computer program stored thereon, characterized in that: When the computer program is executed by a processor, the medical laboratory quality indicator management system based on the ISO15189 standard as described in any one of claims 1 to 8 is implemented.