Method for processing medical laboratory related data

Abstract

This application belongs to the field of data processing. The method for processing medical laboratory-related data provided in the embodiments of this application can obtain the assessment items and assessment standards associated with the target assessment of the medical laboratory. It retrieves the laboratory data corresponding to the assessment items from the medical laboratory's testing equipment and / or associated laboratory information equipment, analyzes whether the laboratory data meets the assessment standards corresponding to the assessment items, and outputs early warning information for cases where the laboratory data does not meet the assessment standards, prompting laboratory managers to improve the assessment items. This application embodiment implements a daily early warning scheme for medical laboratories, eliminating the need for paper documents, improving the automation capability of laboratory-related data processing, and using early warning information to help medical laboratories improve non-compliant items in daily operations, thereby increasing the pass rate during actual assessments.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and more specifically, to methods for processing data related to medical laboratories. Background Technology

[0002] A medical laboratory is a laboratory that analyzes samples taken from the human body for the purpose of diagnosing, preventing, and treating human diseases or assessing human health. Medical laboratories typically have multiple testing devices (which can be integrated into a automated system) for analyzing samples using biological, microbiological, immunological, chemical, immunohematological, hematological, biophysical, cytological, pathological, or other methods. Medical laboratories usually undertake medical and research responsibilities and have a significant social impact.

[0003] To effectively manage medical laboratories, it is necessary to assess aspects such as equipment, personnel, environment, and materials. Summary of the Invention

[0004] In view of this, this application provides a method for processing medical laboratory-related data to assess the equipment, personnel, environment, and materials of a medical laboratory.

[0005] In a first aspect, embodiments of this application provide a method for processing medical laboratory-related data, applied to a server. The medical laboratory is equipped with a sample testing system, which includes at least testing equipment for testing samples using reagents and consumables. The processing method includes:

[0006] Based on the target assessment associated with the medical laboratory, obtain the assessment items included in the target assessment and the assessment standards corresponding to the assessment items;

[0007] Obtain at least one type of laboratory data related to the assessment item from the testing equipment and / or laboratory information equipment associated with the testing equipment in the medical laboratory; wherein the at least one type of laboratory data includes at least one of the following: sample testing data, equipment data of the testing equipment, calibration data of the testing equipment, quality control data of the testing equipment, reagent and consumable data, laboratory personnel data, and laboratory environment data.

[0008] Analyze the data from at least one laboratory related to the assessment item to determine whether the data from at least one laboratory meets the assessment criteria for the assessment item.

[0009] If the data from at least one laboratory does not meet the assessment criteria for the assessment item, an early warning message will be output to indicate that the assessment item has failed the assessment.

[0010] Secondly, embodiments of this application provide a method for processing medical laboratory-related data, applied to a server. The medical laboratory is equipped with a sample testing system, which includes at least testing equipment for testing samples using reagents and consumables. The processing method includes:

[0011] Based on the target assessment associated with the medical laboratory, obtain the assessment items included in the target assessment and the assessment standards corresponding to the assessment items;

[0012] Obtain at least one type of laboratory data related to the assessment item from the testing equipment of the medical laboratory and / or the laboratory information equipment associated with the testing equipment; wherein the at least one type of laboratory data includes at least one of the following: sample testing data, equipment data of the testing equipment, calibration data of the testing equipment, quality control data of the testing equipment, reagent and consumable data, laboratory personnel data, and laboratory environment data;

[0013] Classify and statistically analyze at least one laboratory data related to the assessment item to obtain the assessment data to be assessed related to the assessment item.

[0014] Based on the assessment data related to the assessment items, an assessment report for the target assessment is generated.

[0015] The method for processing medical laboratory-related data provided in this application can obtain the assessment items and standards associated with the target assessment of the medical laboratory. It retrieves laboratory data corresponding to the assessment items from the medical laboratory's testing equipment and / or associated laboratory information equipment, analyzes whether the laboratory data meets the assessment standards, and outputs warning information for cases where the laboratory data does not meet the standards, prompting laboratory managers to improve the assessment item. This application implements a daily warning scheme for medical laboratories, eliminating the need for paper documents, improving the automation of laboratory-related data processing, and using warning information to help medical laboratories improve non-compliant items in daily operations, thereby increasing the pass rate during actual assessments. Attached Figure Description

[0016] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0017] Figure 1A A schematic diagram of the architecture of a medical laboratory-related data processing system provided in this application embodiment;

[0018] Figure 1B A schematic diagram of the architecture of a medical laboratory automated system provided in this application embodiment;

[0019] Figure 2 A flowchart illustrating a method for processing medical laboratory-related data provided in this application embodiment;

[0020] Figures 3A-3B A schematic diagram of the architecture of another medical laboratory-related data processing system provided in this application embodiment;

[0021] Figure 4 An example diagram of the early warning information provided in the embodiments of this application;

[0022] Figure 5 An example diagram of a reminder message provided in an embodiment of this application;

[0023] Figure 6 This is a flowchart illustrating a method for processing medical laboratory-related data, provided in an embodiment of this application. Detailed Implementation

[0024] The technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, and not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0025] Medical laboratories typically include multiple sample analyzers. Sample analyzers are testing devices used to analyze and measure samples. They generally work by adding reagents to the sample and then measuring the sample's reaction results using specific methods to obtain the test results for the required tests. Sample analyzers include, but are not limited to, at least one of the following: biochemical analyzers, immunoassay analyzers, coagulation analyzers, and hematology analyzers. In some medical laboratories, sample analyzers independently perform tests on samples for specific purposes and are not interconnected. In some large medical laboratories, various sample analyzers are integrated into a streamlined system for comprehensive analysis of samples using multiple tests. The medical laboratories in the embodiments of this application may include any of the above types.

[0026] The quality of sample testing conducted by medical laboratories directly impacts the quality of clinical outcomes in hospitals and other medical institutions. To ensure high-quality data support for clinical work, medical laboratories are typically subject to regular or ad-hoc compliance inspections and assessments by testing and assessment organizations, such as the National Health Commission's Clinical Laboratory Center. For example, the Clinical Laboratory Center conducts an inspection and assessment of medical laboratories within its jurisdiction every six months. Alternatively, medical laboratories may voluntarily apply to participate in assessments issued by certain testing and assessment organizations. The inspections and assessments primarily involve collecting data on relevant personnel, reagents and consumables, equipment, and the environment within the medical laboratory and evaluating whether they comply with standards and regulations. For any items that do not meet standards and regulations, the management personnel of the medical laboratory are required to make improvements.

[0027] Currently, the assessment process mainly relies on paper documents, such as paper assessment content and paper-based data collection, and there is no automated solution. Additionally, medical laboratory managers have a need for a way to provide early warnings about non-compliant projects in the laboratory during routine operations outside of assessment periods, in order to help improve these non-compliant projects and thus increase the pass rate during the actual assessment.

[0028] The method for processing medical laboratory-related data proposed in this application can be applied to, for example... Figure 1A The processing system shown includes a server that is communicatively connected to a sample testing system in a medical laboratory.

[0029] It should be noted that the communication connection between the sample testing system and the server only indicates that various laboratory data within the medical laboratory can be collected by the server for routine evaluation; it does not constitute a limitation on the connection method between the various testing devices within the medical laboratory and the server. Specifically, the various testing devices in the medical laboratory can communicate directly with the server, or... Figure 3A The diagram shows the communication connection between the intermediate equipment corresponding to the medical laboratory and the server, and it can also be like... Figure 3B The diagram shows the communication connection between the medical laboratory information management system and the server corresponding to the medical laboratory.

[0030] The sample testing system is located in a medical laboratory and includes at least testing equipment for testing samples using reagents and consumables, such as any of the sample analyzers described above. It should also be noted that the sample testing system in a medical laboratory can include stand-alone testing equipment or a automated system composed of cascaded testing equipment.

[0031] like Figure 1BAn example of a automated system is provided, comprising various types of testing equipment such as blood analyzers, immunoassay analyzers, biochemical analyzers, and coagulation analyzers, which constitute a blood analysis automated system. These testing devices can be connected via analyzer connector modules. In addition to the testing equipment, the automated system also includes modules for pre-processing (hereinafter referred to as pre-processing modules) and post-processing (hereinafter referred to as post-processing modules). Specifically, the pre-processing modules include a sample injection module and a capping module; the post-processing modules include a capping module, a secondary capping module, a low-temperature storage module, and an output module. A transport track cascades the pre-processing modules, various sample analyzers, and post-processing modules to form the automated system. The typical sample testing process is as follows: the sample injection module receives the sample container containing the sample; the container is then transported by a transport rail to the capping module for opening; subsequently, the container is transported by the transport rail to one or more sample analyzers for testing; the analyzers then transport the container by the transport rail to the capping module for capping; finally, the container is transported by the transport rail to the low-temperature storage module for storage, or to the output module for removal by testing personnel. Of course, Figure 1B The provided pipeline system is merely an example; in practical applications, a pipeline system may include more or fewer modules.

[0032] refer to Figure 2 The method for processing medical laboratory-related data provided in this application includes steps S201-S204.

[0033] S201: Based on the target assessment associated with the medical laboratory, obtain the assessment items included in the target assessment and the corresponding assessment standards for each item.

[0034] In this context, target-based assessment refers to the assessments that a medical laboratory will undergo. In practice, organizations managing the quality of medical laboratories can stipulate the assessments that laboratories must participate in, or medical laboratories can proactively request to participate in assessments issued by examination organizations. Any assessment that a medical laboratory needs to participate in within a future period, such as six months or a year, can be considered a target-based assessment.

[0035] Target assessment refers to the name or code of an assessment, which uniquely identifies each assessment. The specific content of the assessment can be called assessment items, and each assessment item also has corresponding assessment standards. For example, the 15189 test is a clinical and diagnostic test issued by the International Organization for Standardization (ISO). It is a specific requirement for accrediting the quality and competence of medical laboratories, including assessments of multiple items such as laboratory equipment, personnel, and environment. Another example is the CNAS assessment issued by the China National Accreditation Service for Conformity Assessment (CNAS), which can certify the competence of medical laboratories.

[0036] For example, CNAS accreditation includes assessment items such as personnel competency requirements, facility and environmental conditions, equipment maintenance and repair, equipment calibration, reagent and consumable requirements, pre-testing procedures, testing procedures, and post-testing procedures. Furthermore, the "testing procedures" include the assessment item of "biological reference range or clinical decision limit" and the assessment item of "internal quality control."

[0037] Taking the assessment item "biological reference intervals or clinical decision limits" as an example, the assessment criteria include: 1) When establishing or transferring reference intervals, laboratories should refer to relevant health industry standards, such as WS / T402, WS / T405, WS / T 779, WS / T780, etc. 2) The review content of biological reference intervals should include: the source of the reference interval, the comparability of the test system results, and the applicability to the reference population, etc., and the review process should be participated in by clinicians. When necessary, reference intervals should be divided according to gender, age, etc.

[0038] Taking "Internal Quality Control" as an example, its assessment criteria include: 1) It is advisable to establish quality control procedures with reference to relevant national / industry standards, such as WS / T 641, including: quality control rules (quality control rules should ensure the stability of the test and the reliability of the test results); the type, concentration, and detection frequency of quality control materials; the location of quality control materials (e.g., for enzyme-linked immunosorbent assays, where applicable, quality control materials should be randomly placed and should cover the test wells); and quality control records. 2) Quality control materials can be commercially available or self-made. 3) Quantitative detection items: at least two concentration levels (normal and abnormal levels) of quality control materials should be used. Quality control charts can be used for statistical analysis of quality control data, including analysis and processing procedures and corrective measures in case of out-of-control situations. 4) Qualitative detection items: negative, weakly positive, and / or positive quality control materials should be set for each experiment, and the quality control data should be analyzed, including whether the negative, weakly positive, and / or positive results meet expectations.

[0039] S202: Obtain at least one type of laboratory data related to the assessment item from the testing equipment and / or laboratory information equipment associated with the testing equipment in the medical laboratory; wherein the at least one type of laboratory data includes at least one of the following: sample testing data, equipment data of the testing equipment, calibration data of the testing equipment, quality control data of the testing equipment, reagent and consumable data, laboratory personnel data, and laboratory environment data.

[0040] The data categories are as follows: Sample testing data refers to the data generated by the testing equipment when testing samples. Equipment data refers to the basic information of the testing equipment itself. Calibration data refers to data related to the calibration process of the testing equipment. Quality control data refers to data related to the quality control process of the testing equipment. Reagent and consumable data refers to data related to the reagents and consumables used in the testing. Laboratory personnel data refers to relevant information about the personnel operating within the medical laboratory. Laboratory environment data refers to data about the environment within the medical laboratory. The specific content of each data category can be found in the following explanation.

[0041] Medical laboratory testing equipment can communicate with laboratory information equipment to send relevant testing data to the laboratory information equipment for storage. Laboratory information equipment refers to devices that store laboratory-related data, which can be retrieved from the medical laboratory's testing equipment and other modules (such as preprocessing modules and post-processing modules).

[0042] Laboratory data may include data from one or more aspects such as equipment, calibration, quality control, reagents and consumables, personnel, and environment. Some or all of the data may come from testing equipment, while some or all of the data may come from laboratory information equipment.

[0043] In some embodiments, laboratory information equipment includes: laboratory information management system equipment and / or intermediate equipment. The laboratory information management system equipment refers to equipment such as a server that is deployed with a Laboratory Information System (LIS).

[0044] This section explains how to obtain relevant laboratory data from the LIS (Laboratory Information System) device. The server communicates with the LIS device, which in turn communicates with various testing devices in the medical laboratory. The server obtains relevant laboratory data from the LIS device, including device data, testing data, quality control data, calibration data, etc., uploaded by each testing device to the LIS device. Figure 3AAs shown, the testing equipment communicates with the LIS system, and the server communicates directly with the LIS system to obtain relevant laboratory data from each testing device. This implementation method eliminates the need for additional intermediate equipment, resulting in lower implementation costs.

[0045] This document explains how to obtain relevant laboratory data from intermediate equipment. Intermediate equipment is installed as a communication channel between the testing equipment and the laboratory information management system in the medical laboratory. It is used to obtain data uploaded by the testing equipment to the laboratory information management system from this communication channel and to extract at least one type of laboratory data related to the assessment items from the uploaded data.

[0046] like Figure 3B As shown, the testing equipment can communicate with the LIS device to upload equipment data, testing data, quality control data, calibration data, etc. An intermediate device is set up on the communication channel between the testing equipment and the LIS device. This intermediate device, also known as a pass-through device, communicates with the server. The intermediate device is used to acquire data uploaded from the testing equipment to the LIS device through the communication channel, extract relevant laboratory data from the acquired data, and send the extracted laboratory data to the server. The intermediate device can also send data that needs to be uploaded to the LIS device to the LIS device.

[0047] Medical laboratories typically include testing equipment from different manufacturers, which may use their own communication protocols and data formats, leading to fragmented management of laboratory data. This implementation method allows extracted laboratory data to be sent via a unified, specific protocol, ensuring consistent data management. Furthermore, the entire process remains seamless for users operating the testing and LIS (Laboratory Information System) equipment, allowing the server to access laboratory data without affecting data uploads from the testing devices.

[0048] S203: Analyze at least one laboratory data related to the assessment item to determine whether the data from at least one laboratory meets the assessment criteria for the assessment item.

[0049] Specifically, based on the assessment items, laboratory data corresponding to each assessment item is selected from the laboratory data. This selected data is then analyzed according to the assessment criteria for each item to determine whether the data meets the criteria. Understandably, each assessment item will yield its own corresponding assessment result, which may include whether it meets or does not meet the assessment criteria. To provide specific improvement information, the assessment results may further include the reasons for non-compliance with the assessment criteria.

[0050] Taking the aforementioned assessment criteria for "indoor quality control" as an example, quality control data for testing equipment can be obtained from laboratory data. This data can then be analyzed to determine if it includes relevant content from quality control procedures, whether the control materials are commercially available or self-made, whether at least two concentration levels of control materials are used, whether negative, weakly positive, and positive control materials are present, and whether the quality control results are analyzed to determine if they meet expectations. If the analysis concludes that the quality control data meets the corresponding quality control standards, then the data is considered to meet the assessment criteria; otherwise, it is considered not to meet the assessment criteria.

[0051] S204: If at least one laboratory data does not meet the assessment criteria for the assessment item, output a warning message to indicate that the assessment item has failed the assessment.

[0052] Specifically, each assessment item will receive its own corresponding assessment result. If a certain type of laboratory data fails to meet the assessment criteria for a particular assessment item, an early warning message will be output. The early warning message can be in various forms, including text, audio, and images. The early warning message is used to indicate that an assessment item has failed, prompting laboratory management personnel to make improvements to that item.

[0053] The output of early warning information can take many forms, such as sending the warning information to a terminal connected to a server. For example... Figure 4 As shown, if the laboratory data for any of the assessment items in "Instruments (Equipment)," "Personnel," "Rules," "Materials (Reagents and Consumables)," or "Environment" does not meet the assessment standards, a warning message "**Operation not in standard" will be sent to the laboratory management personnel's watch, mobile phone, or computer to promptly remind users to adjust the laboratory data that does not meet the assessment standards.

[0054] As can be seen from the above technical solutions, the method for processing medical laboratory-related data provided in this application can obtain the assessment items and standards associated with the target assessment of the medical laboratory. It retrieves laboratory data corresponding to the assessment items from the testing equipment and / or associated laboratory information devices of the medical laboratory, analyzes whether the laboratory data meets the assessment standards corresponding to the assessment items, and outputs early warning information for cases where the laboratory data does not meet the assessment standards, prompting laboratory managers to improve the assessment items. This application implements a daily early warning scheme for medical laboratories, eliminating the need for paper documents, improving the automation capability of laboratory-related data processing, and using early warning information to help medical laboratories improve non-compliant items in daily operations, thereby increasing the pass rate during actual assessments.

[0055] In some embodiments, the server in Figure 1 above may be a server with a LIS system deployed. That is, the LIS system can integrate the processing function of medical laboratory-related data to provide early warnings for daily non-compliant projects in medical laboratories. Specifically, the early warning information can be displayed on the front-end interface of the LIS system.

[0056] In some embodiments, the method for processing medical laboratory-related data further includes: determining the interval between the current time and the assessment time based on the assessment time corresponding to the target assessment, and sending a reminder message to the reminder device associated with the medical laboratory to indicate the assessment time and the interval.

[0057] It is understood that the target assessment to be conducted in the medical laboratory is associated with a specific assessment time. In this embodiment, a countdown reminder can be sent to the user based on the assessment time, and the countdown reminder can be sent to the bound personnel's device (i.e., the reminder device) to remind the user of the countdown until the assessment time. The reminder message can be sent periodically, such as every day or every week depending on actual needs.

[0058] Furthermore, the reminder message also includes a message to prompt the user whether to conduct a warning self-check for the target assessment; the method for processing medical laboratory-related data also includes: if a warning self-check request triggered by the user for the target assessment is received, in response to the warning self-check request, executing the assessment items for the target assessment of the medical laboratory, and obtaining at least one laboratory data related to the assessment items from the testing equipment or the laboratory information equipment associated with the testing equipment.

[0059] like Figure 5 As shown, assuming the countdown to the assessment time is calculated based on the assessment time of "15189", a reminder message "***The exam will be held on ** days later" is sent to the terminals of medical laboratory management personnel, such as watches, mobile phones, and computers. The reminder message can further prompt whether to start the self-inspection process. The terminal interface can display an "Internal Self-Inspection" control. If the user enters a warning self-inspection request through the "Internal Self-Inspection" control on the terminal interface, the server will execute the following... Figure 2 The method for processing relevant medical laboratory data is shown, and warning messages indicating non-compliance with assessment standards are output to the user through the terminal interface.

[0060] In some embodiments, the method for processing medical laboratory-related data further includes: if a user's request to start an exam triggered by a target assessment is received, obtaining at least one type of laboratory data related to the assessment items of the target assessment from the testing equipment and / or the laboratory information equipment associated with the testing equipment; and analyzing the at least one type of laboratory data related to the assessment items to obtain the assessment results of the target assessment.

[0061] In this embodiment, in addition to routine assessments of medical laboratory data, practical assessments of the medical laboratory can also be conducted. The overall process for practical assessments is largely the same as routine assessments; both require acquiring laboratory data and analyzing whether the data meets the assessment standards. The difference lies in that routine assessments focus on adjusting non-compliant laboratory data, while practical assessments primarily aim to obtain the assessment results. Therefore, in this embodiment, the practical assessment obtained after analyzing the laboratory data is the assessment result. The assessment result includes pass or fail, which is derived by comparing all assessment items. For example, if more than a certain number or proportion of assessment items fail, the assessment result is fail; otherwise, the assessment result is pass.

[0062] Furthermore, if the target assessment result is unsuccessful, the system will provide information on the assessment items that do not meet the assessment standards, as well as the relevant laboratory data, to help laboratory managers improve and adjust the laboratory data of the medical laboratory based on the reasons for the unsuccessful assessment.

[0063] The following explains how to set up assessment items.

[0064] In some embodiments, the assessment items can be customized by the user. Specifically, a user interface for configuring assessment items is provided; at least one assessment item configured by the user for the target assessment through the user interface is obtained, and the at least one assessment item configured by the user is used as the assessment item of the target assessment.

[0065] The server can provide a user interface on the terminal, allowing users to configure assessment items through this interface. In some implementations, the user interface may include multiple assessment item options, which can be retrieved from medical laboratory assessment platforms such as the 15189 exam website. Users select some assessment items from the options as the target assessment items.

[0066] In some embodiments, assessment items can be retrieved from an examination website. Specifically, based on the type, level, and location information of the medical laboratory, the target assessment associated with the medical laboratory is determined; and the assessment items and corresponding assessment standards for the target assessment associated with the medical laboratory are obtained from the medical laboratory assessment platform.

[0067] The specific assessment requirements for medical laboratories vary depending on their type (specialized or general), level, and location. For example, a medical laboratory in a tertiary-level Class A specialized children's hospital in Shanghai is required to complete all assessment items in the 15189 assessment. Therefore, all assessment items for this purpose are retrieved from the 15189 exam website as the target assessment items.

[0068] In some embodiments, each type of laboratory data acquired may specifically include the following data items.

[0069] The sample testing data includes at least one of the following: sample pre-testing processing data, sample basic information data, sample testing result data, sample management data, and sample testing report review data; wherein:

[0070] Sample preprocessing data includes at least one of the following: Standard Operating Procedure (SOP) data for sample collection, quality standards for sample acceptance, quality standards for sample rejection, records of sample quality handling that may affect test results (e.g., records of sample handling for jaundice, hemolysis, or lipemia), and markings regarding sample quality in the sample test report. Basic sample information data includes at least one of the following: unique sample identifier (barcode or serial number), test item identifier, sample collection time, sample transport time, sample test time, and basic patient information associated with the sample. This data can be retrieved from LIS and testing equipment; for example, users can manually input the above data into the LIS and testing equipment, or the LIS and testing equipment can automatically retrieve the above data.

[0071] Sample testing result data includes at least one of the following: the sample's testing result or image in the testing item, the unit of the testing result, the reference range of the testing result, a marker indicating that the sample's testing result exceeds the reference range, a marker indicating that the sample's testing result reaches the critical value, the sample's retest results, a comparison between the retest results and the original results, statistical records of samples reaching the critical value within a preset time period, and statistical records of sample testing results within a preset time period. Sample management data includes at least one of the following: the sample's storage time, the sample's storage location, and the sample's storage conditions. Sample testing report review data includes at least one of the following: the review time of the sample testing report, the reviewer of the sample testing report, and explanatory comments on the sample testing report. This data can be retrieved from LIS equipment and testing equipment.

[0072] The equipment data for the testing equipment includes at least one of the following: equipment failure data, equipment maintenance data, equipment evaluation data, equipment environmental data, equipment operation data, and equipment risk management data. Specifically, equipment failure data includes at least one of the following: equipment number, equipment name, equipment model, modules included in the equipment, equipment failure time, equipment failure level, equipment failure type, equipment failure description, personnel handling the equipment failure, and equipment failure handling status. Equipment maintenance data includes at least one of the following: standard operating procedures (SOPs) for equipment maintenance, and execution records of equipment maintenance items (e.g., including equipment number, name, model, asset, module, maintenance details, etc.). The equipment maintenance data includes: maintenance items, maintenance type, maintenance time, maintenance personnel, maintenance results, equipment maintenance frequency, and equipment maintenance timeliness rate; equipment assessment data includes at least one of the following: equipment performance test records, equipment manufacturer certification information, equipment maintenance records, equipment environmental adaptability information records, equipment purchase date, and equipment usage records; equipment environmental data includes at least one of the following: equipment operating environment, operating environment temperature records, and operating environment humidity records; equipment operation data includes at least one of the following: standard operating procedure (SOP) data for equipment operation; and equipment risk management data includes at least one of the following: equipment risk assessment records, equipment potential risks, and equipment potential hazards.

[0073] The calibration data of the testing equipment includes: calibration result records for each calibration item performed by the equipment; the calibration result records include at least one of the following: equipment name, equipment serial number, calibration date, calibration item name, calibrator name, calibrator batch number, calibration method, calibration status, calibration validity period, calibration K value, calibration B value, and calibration R-squared value.

[0074] The quality control data for testing equipment includes at least one of the following: quality control item record data, quality control result statistical values, and quality control chart data; wherein: the quality control item record data includes at least one of the following: equipment name, equipment serial number, quality control date, quality control item name, quality control sample concentration level and batch number, quality control result out-of-control range, quality control result warning range, out-of-control analysis and processing procedure, and out-of-control analysis and processing operation; the quality control result statistical values ​​include at least one of the following: the average quality control result of the medical laboratory, the standard deviation of the quality control result of the medical laboratory, and the coefficient of variation (CV%) of the quality control result of the medical laboratory. The quality control data includes: the number of quality control items in the medical laboratory, the deviation value of the quality control results in the medical laboratory, the average value of the quality control results of the testing equipment group, the standard deviation of the quality control results of the testing equipment group, the coefficient of variation of the quality control results of the testing equipment group, the number of quality control items in the testing equipment group, and the deviation value of the quality control results of the testing equipment group; the quality control chart data includes at least one of the following: the center line and control limits of the quality control chart, the LJ control chart (the LJ chart is a chart method to determine whether the quality control results are qualified by the position of the control limit line and the sample point), the Standard Deviation Index (SDI) quality control chart of internal quality control, the PI quality control chart, and the sigma chart of batch analysis of quality control products.

[0075] The reagent and consumable data includes at least one of the following: reagent and consumable warehousing data, reagent and consumable storage data, and reagent and consumable outbound data. Specifically: reagent and consumable warehousing data includes at least one of the following: reagent and consumable name, reagent and consumable type, reagent and consumable warehousing time, reagent and consumable batch number, reagent and consumable quantity, information of the personnel receiving the reagent and consumable, reagent and consumable inventory statistics, reagent and consumable expiration date, and reagent and consumable expiration period. Reagent and consumable storage data includes at least one of the following: reagent and consumable storage location, reagent and consumable storage temperature, and reagent and consumable storage humidity. Reagent and consumable outbound data includes at least one of the following: reagent and consumable outbound category, reagent and consumable outbound time, reagent and consumable outbound quantity, reagent and consumable specification record, and information of the personnel who retrieved the reagent and consumable. This reagent and consumable data can be obtained from LIS equipment and testing equipment. LIS equipment is equipped with a reagent management system, and testing equipment includes reagent compartments, both of which can record reagent-related information. If the medical laboratory's sample testing system includes a low-temperature refrigeration module, such as a refrigerator, and this module can store reagents, then reagent-related information can also be obtained from this module.

[0076] Laboratory personnel data includes: personnel competency information and personnel training information; among which, personnel competency information includes at least one of the following: personnel education, personnel degree, personnel skill qualification, personnel work experience, and personnel assessment records; personnel training information includes at least one of the following: personnel training content and personnel training plan.

[0077] In some embodiments, laboratory data may also include rules-related data, which may include medical laboratory-related assessment standard documents, application requirement documents, standard description documents, and relevant SOP guidelines and rule description documents developed within the medical laboratory.

[0078] Under the same inventive concept as the above embodiments, this application also provides a method for processing medical laboratory-related data, applied to the server shown in Figure 1. Please refer to... Figure 6 The processing method may include steps S701-S704:

[0079] S701: Based on the target assessment associated with the medical laboratory, obtain the assessment items included in the target assessment and the corresponding assessment standards for each item.

[0080] S702: Obtain at least one type of laboratory data related to the assessment item from the testing equipment and / or laboratory information equipment associated with the testing equipment in the medical laboratory; wherein the at least one type of laboratory data includes at least one of the following: sample testing data, equipment data of the testing equipment, calibration data of the testing equipment, quality control data of the testing equipment, reagent and consumable data, laboratory personnel data, and laboratory environment data.

[0081] For descriptions of the medical laboratory and steps S701-S702, please refer to the above embodiments, which will not be repeated here.

[0082] S703: Classify and statistically analyze at least one laboratory data related to the assessment item to obtain the assessment data related to the assessment item.

[0083] S704: Generate an assessment report for the target assessment based on the assessment data related to the assessment items.

[0084] The classification and statistics process includes two steps: classification and statistics. Classification refers to categorizing laboratory data according to the assessment items; statistics refers to performing statistical analysis on the laboratory data under the same assessment item according to the statistical period, such as compiling monthly comprehensive data, month-on-month comprehensive data, etc., for a specific assessment item. The laboratory data corresponding to each assessment item obtained through classification and statistics can be called the assessment data. By combining the assessment data for all assessment items, an assessment report for the target assessment is obtained. This assessment report is then output so that assessors can review it and evaluate the capabilities of the medical laboratory.

[0085] The method for processing medical laboratory-related data provided in this application embodiment uses laboratory data as source data. The laboratory data can be reorganized into an assessment report through data restructuring, so that assessors can view the assessment report and evaluate the capabilities of the medical laboratory.

[0086] The features described above in the disclosed embodiments can be substituted or combined with each other to enable those skilled in the art to implement or use this application. This document has been described with reference to various exemplary embodiments. However, those skilled in the art will recognize that changes and modifications can be made to the exemplary embodiments without departing from the scope of this document. For example, various operational steps and components for performing operational steps can be implemented in different ways depending on the specific application or considering any number of cost functions associated with the operation of the system (e.g., one or more steps can be deleted, modified, or combined with other steps).

[0087] The terms "first," "second," etc., used in this specification, claims, and the accompanying drawings are used to distinguish different objects, not to describe a specific order. Furthermore, the terms "comprising" and "having," and any variations thereof, are intended to cover non-exclusive inclusion. For example, a process, method, system, product, or apparatus that includes a series of steps or units is not limited to the listed steps or units, but may optionally include steps or units not listed, or may optionally include other steps or units inherent to these processes, methods, or apparatuses.

[0088] Furthermore, as those skilled in the art will understand, the principles herein can be reflected in a computer program product on a computer-readable storage medium pre-loaded with computer-readable program code. Any tangible, non-transitory computer-readable storage medium may be used, including magnetic storage devices (hard disks, floppy disks, etc.), optical storage devices (CD-ROMs, DVDs, Blu-ray discs, etc.), flash memory, and / or the like. These computer program instructions may be loaded onto a general-purpose computer, a special-purpose computer, or other programmable data processing apparatus to form a machine, such that instructions, which execute on the computer or other programmable data processing apparatus, can generate means for performing a specified function. These computer program instructions may also be stored in a computer-readable storage medium that can instruct the computer or other programmable data processing apparatus to operate in a particular manner, such that instructions stored in the computer-readable storage medium can form an article of manufacture, including means for implementing the specified function. The computer program instructions may also be loaded onto a computer or other programmable data processing apparatus to perform a series of operational steps on the computer or other programmable apparatus to produce a computer-implemented process, such that instructions, which execute on the computer or other programmable apparatus, can provide steps for implementing the specified function.

[0089] The foregoing specific descriptions have been described with reference to various embodiments. However, those skilled in the art will recognize that various modifications and changes can be made without departing from the scope of this disclosure. Therefore, considerations for this disclosure are to be illustrative rather than restrictive, and all such modifications are to be included within its scope. Similarly, advantages, other advantages, and solutions to problems with respect to various embodiments have been described above. However, benefits, advantages, solutions to problems, and any elements that produce these, or make them more explicit, should not be construed as critical, essential, or necessary. The term “comprising” and any other variations thereof as used herein are non-exclusive inclusion, meaning that a process, method, product, or apparatus that includes a list of elements includes not only those elements but also other elements not expressly listed or not part of the process, method, system, product, or apparatus. Furthermore, the term “coupled” and any other variations thereof as used herein refer to physical connections, electrical connections, magnetic connections, optical connections, communication connections, functional connections, and / or any other connections.

[0090] The above embodiments are merely illustrative of several implementation methods, and their descriptions are relatively specific and detailed. However, they should not be construed as limiting the scope of this invention. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of this invention, and these all fall within the protection scope of this invention. Therefore, the protection scope of this invention should be determined by the appended claims.

Claims

1. A method for processing medical laboratory-related data, characterized in that, Applied to a server, the medical laboratory is equipped with a sample testing system, which includes at least testing equipment for testing samples using reagents and consumables; the processing method includes: Based on the target assessment associated with the medical laboratory, obtain the assessment items included in the target assessment and the assessment standards corresponding to the assessment items; Obtain at least one type of laboratory data related to the assessment item from the testing equipment and / or laboratory information equipment associated with the testing equipment in the medical laboratory; wherein the at least one type of laboratory data includes at least one of the following: sample testing data, equipment data of the testing equipment, calibration data of the testing equipment, quality control data of the testing equipment, reagent and consumable data, laboratory personnel data, and laboratory environment data. Analyze the data from at least one laboratory related to the assessment item to determine whether the data from at least one laboratory meets the assessment criteria for the assessment item. If the data from at least one laboratory does not meet the assessment criteria for the assessment item, an early warning message will be output to indicate that the assessment item has failed the assessment.

2. The method for processing medical laboratory-related data as described in claim 1, characterized in that, Also includes: Based on the assessment time corresponding to the target assessment, determine the interval between the current time and the assessment time, and send a reminder message to the reminder device associated with the medical laboratory to indicate the assessment time and the interval.

3. The method for processing medical laboratory-related data as described in claim 2, characterized in that, The reminder message also includes a message prompting the user whether to conduct a self-check for the target assessment; The method for processing medical laboratory-related data also includes: If a user triggers a self-inspection request for an early warning regarding the target assessment, in response to the early warning request, the assessment items for the target assessment of the medical laboratory are executed, and at least one piece of laboratory data related to the assessment items is obtained from the testing equipment or the laboratory information equipment associated with the testing equipment.

4. The method for processing medical laboratory-related data as described in claim 1, characterized in that, The laboratory information equipment includes: laboratory information management system equipment and / or intermediate equipment; The intermediate device is set in the communication channel between the testing equipment in the medical laboratory and the laboratory information management system equipment, and is used to obtain data uploaded by the testing equipment to the laboratory information management system equipment from the communication channel, and extract at least one laboratory data related to the assessment item from the uploaded data.

5. The method for processing medical laboratory-related data as described in claim 1, characterized in that, Also includes: If a user requests to start an exam in response to the target assessment, at least one type of laboratory data related to the assessment items of the target assessment is obtained from the testing device and / or the laboratory information device associated with the testing device. Analyze the at least one laboratory data related to the assessment item to obtain the assessment result of the target assessment.

6. The method for processing medical laboratory-related data as described in claim 1, characterized in that, Also includes: Provides a user interface for configuring assessment items; Obtain at least one assessment item configured by the user for the target assessment through the user interaction interface, and use the at least one assessment item configured by the user as the assessment item for the target assessment.

7. The method for processing medical laboratory-related data as described in claim 1, characterized in that, The step of obtaining the assessment items and corresponding assessment standards for the target assessment based on the medical laboratory-related target assessment includes: Based on the type, level, and location information of the medical laboratory, determine the associated target assessments for the medical laboratory; and, Obtain the assessment items and corresponding assessment standards for the target assessment associated with the medical laboratory from the medical laboratory assessment platform.

8. The method for processing medical laboratory-related data as described in claim 1, characterized in that, The sample testing data includes at least one of the following: sample pre-testing processing data, sample basic information data, sample testing result data, sample management data, and sample testing report review data; wherein: The sample pre-processing data includes at least one of the following: standard operating procedure (SOP) data for sample collection, quality standards for sample acceptance, quality standards for sample rejection, sample quality processing records that may affect the sample testing results, and markings on sample quality in the sample testing report. The basic information data of the sample includes at least one of the following: unique sample identifier, test item identifier, sample collection time, sample transportation time, sample testing time, and basic information data of the patient associated with the sample; The sample detection result data includes at least one of the following: the sample's detection result or detection image in the detection item, the unit of the detection result of the detection item, the reference range of the detection result of the detection item, the mark that the sample's detection result exceeds the result reference range, the mark that the sample's detection result reaches the critical value, the sample's retest detection result, the comparison between the sample's retest detection result and the original detection result, the statistical record of the sample's detection result reaching the critical value within a preset time period, and the statistical record of the sample's detection result within a preset time period. The sample management data includes at least one of the following: sample storage time, sample storage location, and sample storage conditions; The sample test report review data includes at least one of the following: the review time of the sample test report, the reviewer of the sample test report, and explanatory comments on the sample test report.

9. The method for processing medical laboratory-related data as described in claim 1, characterized in that, The equipment data of the testing equipment includes at least one of the following: equipment fault data, equipment maintenance data, equipment evaluation data, equipment environmental data, equipment operation data, and equipment risk management data; wherein: The equipment fault data includes at least one of the following: equipment number, equipment name, equipment model, modules included in the equipment, equipment fault time, equipment fault level, equipment fault type, equipment fault description, personnel handling the equipment fault, and equipment fault handling status. The equipment maintenance data includes at least one of the following: standard operating procedures (SOP) data for equipment maintenance, execution records of equipment maintenance items, number of equipment maintenance operations, and equipment maintenance timeliness rate; The equipment evaluation data includes at least one of the following: equipment performance test records, equipment manufacturer certification information, equipment maintenance records, equipment environmental adaptability information records, equipment purchase date, and equipment usage records; The equipment environmental data includes at least one of the following: the equipment's operating environment, operating environment temperature records, and operating environment humidity records; The equipment operation data includes at least one of the following: standard operating procedure (SOP) data for equipment operation; The equipment risk management data includes at least one of the following: equipment risk assessment records, potential equipment risks, and potential equipment hazards.

10. The method for processing medical laboratory-related data as described in claim 1, characterized in that, The calibration data of the testing equipment includes: calibration result records for each calibration item performed by the equipment; the calibration result records include at least one of the following: equipment name, equipment serial number, calibration date, calibration item name, calibrator name, calibrator batch number, calibration method, calibration status, calibration validity period, calibration K value, calibration B value, and calibration R-squared value.

11. The method for processing medical laboratory-related data as described in claim 1, characterized in that, The quality control data of the testing equipment includes at least one of the following: quality control item record data, quality control result statistics, and quality control chart data; wherein: The quality control project record data includes at least one of the following: equipment name, equipment serial number, quality control date, quality control project name, quality control product concentration level and batch number, quality control result out-of-control range, quality control result warning range, out-of-control analysis and processing procedure, and out-of-control analysis and processing operation; The statistical values ​​of the quality control results include at least one of the following: the average quality control results of the medical laboratory, the standard deviation of the quality control results of the medical laboratory, the coefficient of variation of the quality control results of the medical laboratory, the number of quality control items of the medical laboratory, the deviation value of the quality control results of the medical laboratory, the average quality control results of the testing equipment group, the standard deviation of the quality control results of the testing equipment group, the coefficient of variation of the quality control results of the testing equipment group, the number of quality control items of the testing equipment group, and the deviation value of the quality control results of the testing equipment group; The quality control chart data includes at least one of the following: quality control chart center line and control limits, LJ quality control chart, standard deviation index quality control chart of internal quality control, PI quality control chart, and sigma chart of batch analysis of quality control products.

12. The method for processing medical laboratory-related data as described in claim 1, characterized in that, The reagent and consumable data includes at least one of the following: reagent and consumable warehousing data, reagent and consumable storage data, and reagent and consumable outbound data; wherein: The reagent and consumable warehousing data includes at least one of the following: reagent and consumable name, reagent and consumable type, reagent and consumable warehousing time, reagent and consumable batch, reagent and consumable quantity, reagent and consumable receiving personnel information, reagent and consumable inventory statistics, reagent and consumable expiration date, and reagent and consumable expiration period; The reagent and consumable storage data includes at least one of the following: reagent and consumable storage location, reagent and consumable storage temperature, and reagent and consumable storage humidity; The reagent and consumable outbound data includes at least one of the following: reagent and consumable outbound category, reagent and consumable outbound time, reagent and consumable outbound quantity, reagent and consumable specification record, and reagent and consumable outbound personnel information.

13. The method for processing medical laboratory-related data as described in claim 1, characterized in that, The laboratory personnel data includes: personnel competency information and personnel training information; The personnel competency information includes at least one of the following: personnel education, personnel degree, personnel skill qualification, personnel work experience, and personnel assessment records; The personnel training information includes at least one of the following: personnel training content and personnel training plan.

14. A method for processing medical laboratory-related data, characterized in that, Applied to a server, the medical laboratory is equipped with a sample testing system, which includes at least testing equipment for testing samples using reagents and consumables; the processing method includes: Based on the target assessment associated with the medical laboratory, obtain the assessment items included in the target assessment and the assessment standards corresponding to the assessment items; Obtain at least one type of laboratory data related to the assessment item from the testing equipment of the medical laboratory and / or the laboratory information equipment associated with the testing equipment; wherein the at least one type of laboratory data includes at least one of the following: sample testing data, equipment data of the testing equipment, calibration data of the testing equipment, quality control data of the testing equipment, reagent and consumable data, laboratory personnel data, and laboratory environment data; Classify and statistically analyze at least one laboratory data related to the assessment item to obtain the assessment data to be assessed related to the assessment item. Based on the assessment data related to the assessment items, an assessment report for the target assessment is generated.

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