WO2020259466A1 - 个性化临床检验质控方法和设备 - Google Patents

个性化临床检验质控方法和设备 Download PDF

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Publication number
WO2020259466A1
WO2020259466A1 PCT/CN2020/097587 CN2020097587W WO2020259466A1 WO 2020259466 A1 WO2020259466 A1 WO 2020259466A1 CN 2020097587 W CN2020097587 W CN 2020097587W WO 2020259466 A1 WO2020259466 A1 WO 2020259466A1
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Prior art keywords
quality control
information
body fluid
detection system
clinical medical
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PCT/CN2020/097587
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English (en)
French (fr)
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尚雪松
杨启文
徐英春
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金寓润泽(北京)科技有限责任公司
尚雪松
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Publication of WO2020259466A1 publication Critical patent/WO2020259466A1/zh

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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00584—Control arrangements for automatic analysers
    • G01N35/00594—Quality control, including calibration or testing of components of the analyser
    • G01N35/00712—Automatic status testing, e.g. at start-up or periodic
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00584—Control arrangements for automatic analysers
    • G01N35/00594—Quality control, including calibration or testing of components of the analyser
    • G01N35/00613—Quality control
    • G01N35/00623—Quality control of instruments
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00584—Control arrangements for automatic analysers
    • G01N35/00594—Quality control, including calibration or testing of components of the analyser
    • G01N35/00613—Quality control
    • G01N35/00623—Quality control of instruments
    • G01N2035/00653—Quality control of instruments statistical methods comparing labs or apparatuses

Definitions

  • the invention relates to the technical field of clinical medical treatment, in particular to a method and equipment for personalized clinical inspection quality control.
  • the technology of fully automated testing system for clinical laboratories in hospital medical laboratories is now relatively mature. It is the trend of the development of clinical laboratory testing automation in the past internationally and is also the direction of clinical laboratory development.
  • the fully automated inspection system of clinical laboratory refers to the systematic integration of several inspection systems in the clinical laboratory, such as clinical biochemistry, immunology, hematology, etc. It is to combine the same or different analytical instruments with the laboratory before analysis.
  • Indoor quality control is a series of inspection and control methods adopted by each laboratory in order to monitor and evaluate the work quality of the laboratory to determine whether a routine inspection report can be issued.
  • the indoor quality control scheme of each analytical instrument in the laboratory automation assembly line is to use the analytical instrument quality control module for control.
  • relevant regulations we usually follow relevant regulations and carry out indoor quality control at a fixed time and number of times. For example, each test item is run at least once a day, and each item is not less than two levels. For example, for one or more projects, timed quality control is performed once a day according to regulations. For example, if the quality control is performed at 9 o'clock in the morning, the quality control result is in the control state. The quality control is performed again at the same time the next day.
  • control result is out of control, so it may be necessary to re-examine all the patient samples between the two quality controls until all the affected samples are found, which not only consumes time and effort, reduces the detection efficiency, and may even lead to the test results of the patient samples Something went wrong.
  • the present invention provides a personalized clinical test quality control method, including:
  • the user setting information includes quality control item information, quality control rule information corresponding to the quality control item information, and quality control time information;
  • the quality control time information start the clinical medical body fluid detection system to absorb quality control products, and analyze the absorbed quality control products to obtain measured values about the quality control item information;
  • the quality control time information includes interval time information and first start time information.
  • the user setting information further includes skip time information, which is used to instruct the clinical medical body fluid detection system to suspend the time period for performing the quality control operation.
  • the user setting information further includes sample batch information, and the sample batch information is used to indicate a quantity threshold.
  • the sample batch information is used to indicate a quantity threshold.
  • the quality control item information includes quality control name information and concentration level information.
  • the user setting information further includes analyzer information; the clinical medical body fluid detection system is activated according to the quality control time information to absorb quality control products, and the absorbed quality control products are analyzed to obtain information about the quality control items
  • the clinical medical body fluid detection system is made to transfer the storage tube containing the quality control product to the corresponding analyzer according to the analyzer information, so that it can absorb the quality control product, and analyze to obtain The measured value of the quality control item information.
  • the user setting information further includes the maximum number of times of use; after analyzing the absorbed quality control product to obtain the measured value of the quality control item information, record the number of times the current quality control product is used, and determine Whether the number of uses reaches the maximum number of uses; when the number of uses reaches the maximum number of uses, the clinical medical body fluid detection system is controlled to discard the remaining quality control products.
  • the user setting information further includes the quality control product number; in the step of starting the clinical medical body fluid detection system to absorb the quality control product according to the quality control time information, the clinical medical body fluid detection system Control product number Take the storage tube containing the quality control product from the storage module.
  • the same quality control item information corresponds to multiple different quality control rule information.
  • the present invention provides a personalized clinical laboratory quality control equipment, including: at least one processor; and a memory communicatively connected with the at least one processor; wherein the memory stores the memory that can be used by the one processor
  • the executed instruction is executed by the at least one processor, so that the at least one processor executes the above-mentioned clinical medical body fluid detection quality control method.
  • the present invention applies the body fluid detection system to quality control, allowing users to set quality control items, quality control time, and quality control rules according to laboratory needs. After entering these setting information, the quality control products can be absorbed on time with the help of each module of the system And measurement, and then automatically obtain the quality control results according to the preset quality control rules, so that the quality control work can be automated and personalized, which can meet the quality control needs of various clinical medical laboratories, and avoid human operations on the quality control process.
  • the impact of quality control improve the efficiency of quality control work and the accuracy of quality control results.
  • the system can execute multiple quality control items once the quality control product is absorbed by the system, and can accurately control the amount of quality control product absorbed, which can be obvious Save the amount of quality control products and reduce the cost of quality control products.
  • Figure 1 shows a schematic structural diagram of a clinical medical body fluid detection system
  • Figure 2 shows a schematic diagram of a personalized clinical test quality control method in an embodiment of the present invention
  • Figure 3 shows a schematic diagram of an automated clinical inspection quality control method in an embodiment of the present invention
  • Figure 4 shows a schematic diagram of a clinical laboratory quality control device according to an embodiment of the present invention
  • Figure 5 is a front view of a storage tube for quality control analytes provided by the present invention.
  • Figure 6 is a top view of a storage tube for quality control analytes provided by the present invention.
  • Figure 7 is a partial schematic view of the nozzle provided by the present invention.
  • Fig. 8 is a schematic diagram of a preferred scheme of a storage tube for quality control analytes provided by the present invention.
  • the clinical medical body fluid detection system includes a detection system 10 and a data management system 20.
  • the data management system may be a computer or a server.
  • the detection system 10 includes a rail transport module 111, and a sample injection module 11, an identification module 12, a centrifugation module 13, a cover removal module 14, a film removal module 15, at least one analytical instrument 16, and a sealing film connected to the rail transport module 111 in sequence.
  • the data management system 20 communicates with the detection system 10, and the management system software is installed in the data management system 20, and the management system software in the data management system 20 is used to control and control the work of the detection system.
  • the sampling module 11 sends the body fluid sample to the orbital transmission module 111.
  • the orbital transmission module 111 transfers the body fluid sample to the analyzer.
  • the analyzer performs sampling and testing on the body fluid sample.
  • the analyzer is connected to the data management system 20, and the analyzer collects the data. It is transmitted to the data management system 20, and the data management system 20 analyzes and processes the data collected by the analyzer.
  • the detection system includes at least one sampling module 11 and at least one sampling module 19.
  • the sampling module 11 and the sampling module 19 are configurable to load and unload the body fluid sample test tubes on the rail transport module.
  • the sampling module 11 and the sampling module 19 may be manipulators or other devices for loading and unloading body fluid samples.
  • the centrifugation module 13 can automatically centrifuge the body fluid samples.
  • the cap removal module 14 can disassemble the plastic screw cap and pressure cap of the main sample test tube.
  • the film removal module can remove the sealing film of the sample test tube sealed by the film sealing module 17.
  • the cup module can generate auxiliary sample test tubes from existing main sample test tubes.
  • the film sealing module 17 uses a sealed door to seal the test tube.
  • the sealing film is cut, and then heat-sealed to each plastic sample tube.
  • the capping block can place the screw cap on the auxiliary sample test tube generated by the sub-cup module.
  • the storage module stores the sealed sample test tube in a temperature-controlled environment, and it can include a storage bench and an automatic freezer.
  • the body fluid sample is placed in a test tube, and the test tube is provided with a label for marking the body fluid sample information.
  • the specific label may be an identification code such as a QR code. Or electronic tags.
  • the sample injection module 11 places the body fluid sample on the rail transport module 111, and the identification module 12 identifies the label on the test tube.
  • the centrifugation module 13 performs automatic centrifugation, and then enters the cap removal module 14 or the membrane removal module 15, which can be specifically selected according to the seal on the test tube.
  • the sample is transported to the analyzer by the rail transport module 111 ,
  • the analyzer can identify the body fluid sample information through the label on the test tube, the analyzer performs aspiration analysis on the sample, and then enters the sealing film module 17 for sealing.
  • the body fluid sample is transferred to the storage module by the track transmission module 111 112.
  • the sampling module 19 puts the body fluid sample back into the storage module for storage.
  • an embodiment of the present invention provides a personalized clinical laboratory quality control method.
  • the quality control in this application refers to internal quality control in a clinical laboratory, which is involved in this application
  • the method provided by the embodiment of the present invention may be executed by the above-mentioned data management system 20, or executed by an external terminal.
  • the method includes the following steps:
  • User setting information includes quality control item information, corresponding quality control rule information and quality control time information.
  • the quality control item information is used to indicate the quality control target, such as the name or abbreviation of the quality control item. As an example, the information can be "transaminase” or "ALT".
  • Quality control rules are the decision-making criteria for interpreting quality control data and making quality control status judgments.
  • the quality control measurement value exceeds the quality control limit specified by the quality control rules, it is judged that the analysis batch violates this rule and is regarded as out of control.
  • the available quality control rules are 1 2s , 1 3s , 2 2s , R 4s , 4 1s , 10 X , and they have different meanings. Taking 1 2s as an example, it means that when a quality control measurement value exceeds X ⁇ 2s, it is judged to be out of control.
  • Quality control rules can be set subjectively by users, or the system can collect historical quality control data and automatically generate appropriate quality control rules based on the OPSpecs chart. Specifically, the system can collect the quality control result data that the user has manually executed and entered before, and then calculate the sigma measurement value for each quality control project, and generate the OPSpecs chart according to the project type and the sigma measurement value, and set the required The critical system error (pfr ⁇ 5%) and rejection probability (ped>90%) automatically generate quality control rules suitable for the project.
  • the user can set multiple different quality control rule information for the same quality control project.
  • the user can be allowed to set multiple quality control rules such as 1 2s , 1 3s , and 2 2s at the same time.
  • the quality control time information is used to set the time and/or cycle of the clinical medical body fluid testing department to perform the quality control operation and the timing of the quality control.
  • S20A start the clinical medical body fluid detection system to absorb quality control products, and analyze the absorbed quality control products to obtain the measured value of the quality control item information.
  • start for example, you can send the start time to the detection system, and then the detection system saves these settings, and starts sampling and analysis whenever the start time is reached; or sends a start command to the detection system when the start time is reached to wake it up Perform sampling and analysis.
  • the analytical instrument 16 in the control quality clinical medical body fluid detection system absorbs the quality control product and analyzes the transaminase content therein, that is, the measured value of the quality control item information.
  • S30A analyze the measured value according to the information of the quality control rules, and obtain the quality control results of each quality control item.
  • the analysis instrument 16 obtains the measured value, it sends the result back to the terminal that executes the method, and then the terminal analyzes it according to the preset quality control rules such as 12s , and obtains the quality control result, such as in a controlled state or out of control state.
  • quality control products are pre-placed in the storage module 112 in the clinical medical body fluid detection system, and the sampling module 19 is controlled to take out the quality from the storage module 112 according to the set quality control time.
  • the control product is placed on the rail transport module 111 and enters the analysis instrument 16, and the quality control product is absorbed for analysis to obtain the measured value of the quality control item. Then analyze the measured value according to the quality control rule information to obtain the quality control result.
  • the terminal executing this method can present an interactive interface to the user, and the user can set the above-mentioned information.
  • the terminal can allow users to add multiple different quality control item information (such as enzymes, ions, proteins, etc.) as needed, and set their quality control time and quality control rules respectively.
  • the quality control time and quality control rules of different quality control items can be the same or different, and they can be set according to user needs.
  • the quality control method provided by the embodiment of the present invention applies a body fluid detection system to quality control, allowing users to set quality control items, quality control time, and quality control rules according to laboratory needs. After entering these setting information, use each module of the system The quality control products are absorbed and measured on time, and then the quality control results are automatically obtained according to the preset quality control rules, so that the quality control work can be automated and personalized, which can meet the quality control needs of various clinical medical laboratories and avoid artificial The impact of the operation on the quality control process improves the efficiency of quality control work and the accuracy of quality control results.
  • the present invention uses the clinical medical body fluid detection system to perform quality control, and does not affect its detection of body fluid samples.
  • the detection system reaches the time when the quality control should be carried out in the process of detecting the body fluid sample, it is enough to switch to the detection quality control product.
  • the system shown in FIG. 1 reaches the quality control time, there are body fluid samples being tested or waiting to be tested on the orbital transport module 111.
  • the system can be controlled to complete the testing of these body fluid samples, and no longer Transmit untested body fluid samples, and immediately transmit quality control products to perform testing after the test is completed; or you can control the system to immediately suspend the testing of these samples, send them back to the storage module 112, and immediately transmit quality control products to perform testing, pending quality control Continue to test body fluid samples after completion.
  • the aforementioned quality control item information includes quality control name information and concentration level information.
  • the name information of the two quality control items are "Albumin 1" and “Albumin 2", indicating two levels of albumin.
  • the user can set the same or different quality control rules and quality control time for these two levels.
  • the rule 1 2s is adopted for the quality control product with the level information "1”
  • the quality control product with the level information "2” is adopted Rule 1 2s and Rule 1 3s .
  • the corresponding relationship is shown in the following table:
  • This information is set by the user, or default information is provided and the user is allowed to modify it.
  • the detection system can draw according time1 albumin level is "1", control materials, to give the corresponding measured values, according to a quality control results in a 2S analyzed in step S30A; according to the detection system after suction time2 albumin level is "2" quality control materials, to give the corresponding measured values, according to 1 2s 1 3s and quality control results analyzed in the step S30A.
  • the frequency of running at different levels can be different.
  • the quality control rule of "Albumin 1" is 1 3s /2 2s /r 4s /6 x
  • the frequency of 2 means that the quality control needs to be run twice a day
  • the quality control rule is 1 3s
  • a frequency of 1 means that the quality control is run once a day.
  • multi-level automatic quality control can be realized, and the quality of quality control results can be improved.
  • each storage tube may store the same quality control product or different quality control products (for example, different concentration levels).
  • the user setting information may also include the quality control product number, or called the storage tube number.
  • the corresponding relationship between the quality control product number and other information is as follows:
  • Quality control project information Storage tube number Quality control rules Time information albumin qc01 1 2s time1 Transaminase qc02 1 2s , 1 3s Time2
  • the sampling module 19 takes out the storage tube qc02 from the storage module 112, and transmits it to the analytical instrument 16 through the orbital transmission module 111, and sucks it into the storage tube qc02 Analyze the quality control products to obtain the measured value of the transaminase content, and then determine the quality control results according to 12s and 13s .
  • the purpose of the quality control product number is to make the clinical medical body fluid detection system take out the storage tube required for the quality control item from the storage module in step S20A.
  • Existing systems are generally equipped with code scanning devices.
  • the quality control product number is affixed to the storage tube in the form of a bar code.
  • the position of the storage tube can be recorded by scanning the bar code when sampling, and the corresponding storage tube can be taken out according to the number when sampling .
  • the user setting information can also include the maximum usage count.
  • the correspondence between the maximum usage times and other information is as follows:
  • step S20A each time the analyzer 16 absorbs the quality control product from the storage tube qc01, it records the number of uses of the current quality control product (storage tube), and determines whether the current number of uses reaches the maximum number of uses of 7 times.
  • the clinical medical body fluid detection system transfers the storage tube qc01 through the track and the sampling module back to the storage module for the next use; when the number of uses reaches the maximum number of uses of 7, the clinical The medical body fluid detection system discards the remaining quality control products, that is, discards the storage tube qc01.
  • the user refills the quality control product and re-enables the storage tube qc01, the recorded use times are reset.
  • the user setting information may also include analyzer information.
  • analyzer information As an example, the correspondence between analyzer information and other information is as follows:
  • Quality control project information Storage tube number Analyzer information Quality control rules Time information albumin qc01 C16000-3 1 2s time1 Transaminase qc02 C16000-2 1 2s , 1 3s time1
  • step S20A the system transmits the storage tube qc01 to the analyzer C16000-3 through the orbital transmission module, and the analyzer absorbs the quality control product and obtains the measured value of the albumin content.
  • the user setting information may also include sample batch information, which is used to indicate the timing for the detection system to initiate quality control in the process of detecting the body fluid sample.
  • the sample batch information is used to indicate the number threshold n.
  • the sample batch information and the above-mentioned quality control time information coexist, and the quality control starts when either condition is reached.
  • sample batch information As an exemplary description, the corresponding relationship between sample batch information and other information is as follows:
  • Quality control project information Storage tube number Sample batch information Quality control rules Time information albumin qc01 n1 1 2s time1 Transaminase qc02 n2 1 2s , 1 3s time1
  • the method further includes: monitoring the number of body fluid samples or items continuously detected by the clinical medical body fluid detection system, and when the number reaches the number threshold indicated by the sample batch information, the quality control product is started to be tested to perform the corresponding quality control project. For example, when the system continuously detects n1 individual fluid samples, it starts to detect the quality control product to obtain the measured value of albumin, and analyze the quality control result.
  • the clinical medical body fluid test when the clinical medical body fluid test is in normal work, that is, when the patient's body fluid sample is tested, it is monitored whether it meets the quality control start condition indicated by the sample batch information, so as to automatically switch it from the working state to the quality control state. This prevents it from being out of control and reduces the probability of error in the test results of the patient sample.
  • the above-mentioned quality control time information may specifically include interval time information, for example, a few hours; the quality control time information may also include first start time information, indicating that the quality control is executed for the first time in a day Point in time.
  • interval time information for example, a few hours
  • first start time information indicating that the quality control is executed for the first time in a day Point in time.
  • Quality control project information Storage tube number Quality control rules First start time Intervals albumin qc01 1 2s 6:00 8 hours Transaminase qc02 1 2s , 1 3s 6:00 12 hours
  • step S20A the clinical medical body fluid detection system is activated at 6:00 every day to absorb the quality control product, obtain the measured value of albumin, and analyze the quality control result. Then re-execute the quality control of albumin every 8 hours (3 times a day).
  • the user setting information also includes skip time information, which is used to instruct the clinical medical body fluid detection system to suspend the time period for performing the quality control operation. For example, the user can set a certain day of a certain year, certain month, as the skip time, and the system will not start to perform quality control on this day.
  • This information can be set by the user. According to quality control requirements, set the above time information for different quality control items.
  • the personalized quality control While performing the personalized quality control as in the above-mentioned embodiment, it can also monitor whether the system is out of control based on the test results of the body fluid sample in real time when testing the patient's body fluid sample. Once a test item is found to be out of control, the system is controlled Suspend/automatically review/or suspend the testing of patient samples and switch to implementing related quality control items.
  • the specific method is shown in Figure 3. Based on the steps of the above-mentioned embodiment, the quality control method may further include the following steps:
  • the body fluid sample may include blood, urine, and tissue fluid.
  • the detection items can include the detection of various enzymes in body fluids. For example, alanine aminotransferase, alanine transferase, etc., and the detection of various ions, such as potassium, calcium, and sodium ions. Or other test items, for example, albumin, globulin and other test items. Exemplary so-called test data are test results of test items of patients.
  • S20B Perform a moving average calculation on the detection data to obtain the moving average of the detection item.
  • the following method can be used to calculate the moving average: if the measured values are obtained in sequence (x 1 , x 2 , x 3 ,..., x n ), take a certain number in order All arithmetic average. E.g You can get the moving average. Of course, in this embodiment, it is also possible to take two data in order as an average value.
  • the moving average algorithm includes a variety of methods, such as a primary moving average method or a secondary moving average method, etc.
  • the present invention can use any moving average algorithm to obtain the moving average of the detection item.
  • S30B Determine whether the moving average value of the detection item exceeds a preset threshold.
  • the preset threshold value can be determined according to the detection result of the hospital test sample.
  • the preset threshold value can be changed at any time according to the detection data obtained by the detection, and can be changed by time according to the detection moving average. Sequentially trace the moving average points. When the moving average point falls within the preset threshold, the test data of the test item is considered normal, and when the moving average point falls outside the preset threshold, the test result of the test item is considered to exist. problem.
  • the analyzer determines whether the moving average exceeds a preset threshold. It can continuously detect whether multiple moving averages exceed the preset threshold, or continuously detect whether multiple moving averages exceed the preset threshold among multiple preset thresholds, that is, multiple movements occur at intervals in a short time The case where the mean value exceeds the preset threshold.
  • the moving average exceeds the preset threshold in order to avoid random situations, you can start from the first occurrence of the moving average that exceeds the preset threshold, and you can continuously observe whether the subsequent two or three moving averages If two or three consecutive moving averages exceed the preset threshold from the first moving average that exceeds the preset threshold, you can confirm that the moving average of the current test item exceeds the standard and output a prompt message. For example, it can be displayed on the operation screen of clinical medical body fluid detection that there may be a certain problem in the detection of a certain item, or output voice prompts.
  • step S40B is entered, and when the moving average value of the detection item is within the preset range, step S10B is returned.
  • a quality control product also called a quality control analyte
  • a quality control product is placed in the storage module of the clinical medical body fluid detection system in advance, and after the moving average of the detection item exceeds a preset threshold, the sampling module 19 is controlled to be taken out of the storage module
  • the quality control product is placed on the orbital transmission module 111 and enters the analyzer, and the quality control analysis of the corresponding detection item whose moving average value exceeds the preset threshold value is performed.
  • the orbital transmission module 111 may include an emergency channel 113.
  • the quality control product can be controlled to enter the emergency channel 113 and enter the analyzer for quality priority. Control to complete the quality control of the current test items in the shortest time.
  • the body fluid sample is continuously detected, and subsequent body fluid samples that have the detection item when the moving average value is confirmed to be out of control are labeled with a label to be checked.
  • the label to be checked can be associated with the identification label of the body fluid sample. Since the moving average exceeds the preset threshold, it cannot be completely confirmed that the test item is out of control, so the normal test of the sample can be continued first to avoid affecting the test efficiency.
  • the clinical medical body fluid detection system when the moving average value of the detection item exceeds the preset threshold, the clinical medical body fluid detection system is controlled to offline the detection item, and the so-called offline detection item may be stopping the current analyzer sample injection.
  • the body fluid sample with the detection item can be stopped from entering the current analyzer.
  • the body fluid sample with the detection item is transported to other online analyzers to continue the aspiration detection.
  • the analysis instrument 16 is controlled to be in quality according to the preset quality control rules.
  • the indoor quality control data corresponding to the test item is collected in the control product, and the indoor quality control data is analyzed.
  • the quality control rules corresponding to different test items are based on the actual situation. At least one rule can be selected from the six sigma rules for quality control.
  • the quality control rules can include: 1 3s , 2 2s , 3 2s , r 4s , 6 x , 8 x , 9 x , 10 x , 15s, etc.
  • the control rule takes 13s as an example.
  • the quality control result is judged to be out of control.
  • the body fluid sample of the current test item is retested. Specifically, If the moving average of the test item exceeds the preset threshold, the analyzer continues to inject and test, and the body fluid sample with the label to be checked can be retested. Since the moving average exceeds the preset threshold for the first time, in order to prevent random events, the subsequent samples will be labeled only when the number of moving averages in consecutive body fluid samples exceeds the preset threshold is greater than the preset number Therefore, re-examination of only body fluid samples with labels to be checked may be missed.
  • the embodiment of the present invention also provides a clinical laboratory quality control device, including: at least one processor; and a memory communicatively connected with the at least one processor; wherein the memory stores instructions executable by one processor, and the instructions are at least One processor executes, so that at least one processor executes the above clinical medical body fluid detection quality control method.
  • the above-mentioned clinical medical body fluid detection quality control equipment 100 includes one or more processors 102 and one or more storage devices 104.
  • the electronic device 100 may further include an input device 106 and an output device 108, and these components are interconnected by a bus system 110 and/or other forms of connection mechanisms (not shown).
  • bus system 110 and/or other forms of connection mechanisms (not shown).
  • the components and structure of the electronic device 100 shown in FIG. 4 are only exemplary and not restrictive, and the electronic device may also have other components and structures as required.
  • the processor 102 may be implemented in the form of at least one of digital signal processing (DSP), field programmable gate array (FPGA), and programmable logic array (PLA).
  • DSP digital signal processing
  • FPGA field programmable gate array
  • PDA programmable logic array
  • the processor 102 may be a central processing unit (CPU), One or a combination of image processing units (GPU), dedicated integrated circuits (ASIC) or other forms of processing units with data processing capabilities and/or instruction execution capabilities, and can control other components in the electronic device 100 Component to perform the desired function.
  • CPU central processing unit
  • GPU One or a combination of image processing units
  • ASIC dedicated integrated circuits
  • the storage device 104 may include one or more computer program products, and the computer program products may include various forms of computer-readable storage media, such as volatile memory and/or non-volatile memory.
  • the volatile memory may include random access memory (RAM) and/or cache memory (cache), for example.
  • the non-volatile memory may include, for example, read-only memory (ROM), hard disk, flash memory, etc.
  • One or more computer program instructions may be stored on the computer-readable storage medium, and the processor 102 may run the program instructions to implement the client functions and/or other desired functions in the above-mentioned embodiments of the present invention (implemented by the processor) .
  • the computer-readable storage medium may also store various application programs and various data, such as various data used and/or generated by the application program.
  • the input device 106 may be a device used by the user to input instructions, and may include one or more of a keyboard, a mouse, a microphone, and a touch screen.
  • the output device 108 may output various information (for example, images and/or sounds) to the outside (for example, a user), and may include one or more of a display, a speaker, and the like.
  • the input device 106 and the output device 108 may be integrated together and implemented using the same interactive device (such as a touch screen).
  • the electronic device for clinical medical body fluid detection quality control may be implemented on a device such as a personal computer or a remote server.
  • the embodiment of the present invention provides a clinical medical quality control system, including: a clinical medical body fluid detection system and the above-mentioned quality control equipment, the equipment is in communication connection with the clinical medical detection system.
  • a clinical medical body fluid detection system is not limited to the structure shown in Figure 1. There are many existing detection systems, as long as the detection system has the function of automatically sampling and analyzing quality control products is feasible.
  • the quality control system further includes a mobile terminal, such as a general-purpose smart phone or a dedicated PDA (Personal Digital Assistant).
  • the quality control equipment sends the quality control results to the mobile terminal, so that remote users can understand the quality control status in time.
  • the mobile terminal can cooperate with the quality control device to execute the above quality control method.
  • the quality control device is used to control the clinical medical body fluid detection system, that is, step S20A is executed according to part of the information in step S10A, and the mobile terminal is used to determine the quality control result , That is, execute step S30A according to the partial information in step S10A.
  • the mobile terminal is used to send quality control control instructions, such as restart, pause, and so on.
  • quality control control instructions such as restart, pause, and so on.
  • This allows remote users to control the quality control equipment according to the quality control status. For example, when an out-of-control situation occurs, the quality control equipment can send instructions to re-execute the last quality control operation, verify the out-of-control situation, and so on.
  • the embodiments of the present invention may be provided as methods, systems, or computer program products. Therefore, the present invention may adopt the form of a complete hardware embodiment, a complete software embodiment, or an embodiment combining software and hardware. Moreover, the present invention may adopt the form of a computer program product implemented on one or more computer-usable storage media (including but not limited to disk storage, CD-ROM, optical storage, etc.) containing computer-usable program codes.
  • a computer-usable storage media including but not limited to disk storage, CD-ROM, optical storage, etc.
  • These computer program instructions can also be stored in a computer-readable memory that can guide a computer or other programmable data processing equipment to work in a specific manner, so that the instructions stored in the computer-readable memory produce an article of manufacture including the instruction device.
  • the device implements the functions specified in one process or multiple processes in the flowchart and/or one block or multiple blocks in the block diagram.
  • These computer program instructions can also be loaded on a computer or other programmable data processing equipment, so that a series of operation steps are executed on the computer or other programmable equipment to produce computer-implemented processing, so as to execute on the computer or other programmable equipment.
  • the instructions provide steps for implementing functions specified in a flow or multiple flows in the flowchart and/or a block or multiple blocks in the block diagram.
  • an embodiment of the present invention provides a storage tube for quality control analytes for storing the above-mentioned quality control products.
  • the storage tube includes a nozzle 1, an upper tube body 2 and a lower base 4 connected from top to bottom; the nozzle 1, the upper tube body 2 and the lower base 4; the nozzle 1 is surrounded by a tube wall Therefore, from the upper tube body 2 to the nozzle 1, the thickness of the tube wall gradually becomes thinner.
  • the thickness of the pipe wall at the connection between the upper pipe body 2 and the nozzle 1 and the upper pipe body 2 is 0.8 mm
  • the pipe wall thickness at the top of the nozzle 1 is 0.1 mm
  • the pipe The length of the mouth 1 is 6 mm
  • the radius of the mouth 1 is 12 mm.
  • a cover or film can be added to the upper part of the mouth 1 to make it meet the requirements of a sterile environment in the medical field when it leaves the factory.
  • the upper tube body 2 is surrounded by a tube wall.
  • a middle cavity 3 is formed inside the upper tube body 2.
  • the upper part of the middle cavity 3 communicates with the outside, and the lower part of the middle cavity 3 is connected to the lower part.
  • the base 4 is in contact, and the middle cavity 3 is used for storing quality control products.
  • one or more magnetic mixing beads are added inside the middle cavity 3 to enable magnetic mixing on the assembly line (equivalent to the above-mentioned clinical medical body fluid detection system); the wall thickness of the upper tube 2 It is 0.8 mm, and the length of the upper tube body 2 is 75 mm or 100 mm.
  • the lower base 4 has a truncated cone-shaped structure with a wide upper and a narrow lower base, and a cylindrical bottom cavity 5 inside; the upper end of the bottom cavity 5 is in contact with the outer wall of the lower base 4, and the bottom cavity 5 The lower end is connected with the outside world.
  • reinforcing ribs 6 are evenly distributed on the inner wall of the nozzle 1 so that the nozzle 1 is not easily damaged. Specifically, a downward pressure is applied to the nozzle 1 during the assembly line sealing film. Because the nozzle 1 in this embodiment is very thin, it may be deformed or broken when subjected to the downward pressure. In order to strengthen the nozzle 1 It is not damaged by the film sealing device of the assembly line, and several reinforcing ribs can be arranged at the nozzle 1. In other embodiments, the reinforcing ribs may also be arranged on the outer wall of the nozzle 1. Because in some application scenarios, the storage tube has a cover, the reinforcing ribs 6 on the inner wall may not be plugged or tightly sealed, so the reinforcing ribs are preferably arranged on the outer wall.
  • the material of the storage tube contains glass fiber, which can harden the tube body and is not easy to deform when subjected to downward pressure.
  • Figure 8 provides three preferred solutions at the same time.
  • the bottom cavity 5 is provided with a filler 7, and some brands of the assembly line are installed on the base of the storage tube.
  • the storage tube needs to be removed from the If the bottom cavity 5 is hollow, the thimble on the base cannot lift up the storage tube, so it is necessary to provide the filling body in the bottom cavity 5 7.
  • the thimble of the base can push up the entire storage tube.
  • the filling body 7 is a short column, the upper part of the short column is connected to the center of the upper end of the bottom cavity 5, and the radius of the short column is smaller than the radius of the bottom cavity 5.
  • the purpose of the column is to cooperate with the automatic biochemical detection pipeline.
  • the filling body 7 is composed of a battery, an electromagnetic switch and a motor.
  • This setting is to enable the storage tube to vibrate or shake, thereby mixing the quality control analytes in the storage tube.
  • a corresponding magnetic switch is provided on the pipeline.
  • the electromagnetic switch in the filling body 7 is triggered to make the motor
  • the short-term operation causes the storage tube to vibrate briefly, thereby realizing the mixing operation.
  • the magnetic switch on the assembly line can be set at any module before the analysis instrument 16, so that the storage tube can complete mixing before reaching the analysis instrument 16.
  • the bottom cavity 5 and the middle cavity 3 are arranged separately, and the lower base 4 and the upper tube 2 are detachably connected by a plug connection or a screw connection, so that the belt The lower base 4 with the motor can be used repeatedly, and the upper tube 2 can be discarded after use.
  • the outer wall of the nozzle 1 gradually shrinks inward from bottom to top, and the place where the reinforcing rib 6 is arranged is kept consistent with the diameter of the middle part of the upper tube body 2.
  • the storage tube enters the assembly line from the refrigerator, and a corresponding magnetic switch is arranged on the assembly line.
  • the electromagnetic switch in the filling body 7 is triggered to make the motor Run for a short time to make the storage tube vibrate for a short time to realize the mixing operation; then enter the opening module, the nozzle 1 has a cap, and the cap is screwed up initially. The cap will be removed during the first sampling of the assembly line.
  • the thimble on the assembly line base is pushed into the bottom cavity 5 to contact the filling body 7, and the storage tube is pushed up, and the sampling needle extends into the middle cavity 3 for analysis
  • the instrument performs quality control analysis; after sampling, it enters the film sealing module, and seals a film on the nozzle 1.
  • the material of the film is generally aluminum foil and other soft metal materials, and there is glue on the surface.
  • the assembly line sticks the film on On the nozzle 1; the storage tube after the final sealing film returns to the refrigerator.
  • Quality control needs to be performed periodically, that is, the above process needs to be performed several times a week, or even several times a day. Therefore, the storage tube is frequently sealed and uncovered.
  • the thickness of the tube wall at the top of the nozzle 1 is only 0.1 mm, so the contact area with the film is small, and the sealing film will not be unable to be removed during frequent operations.

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Abstract

一种个性化临床检验质控方法和设备，质控方法包括：获取用户设置信息，用户设置信息包括质控项目信息、与质控项目信息对应的质控规则信息和质控时间信息(S1A)；根据质控时间信息启动临床医疗体液检测系统吸取质控品，并对吸取的质控品进行分析得到关于质控项目信息的测定值(S2A)；按照质控规则信息针对测定值进行分析，得到关于质控项目的质控结果(S3A)。

Description

个性化临床检验质控方法和设备 技术领域
本发明涉及临床医疗技术领域，具体涉及一种个性化临床检验质控方法和设备。
背景技术
医院医疗实验室临床实验室全自动化检验系统技术现己比较成熟，是自前国际上临床实验室检验自动化发展的趋势，也是临床实验室发展的方向。临床实验室全自动化检验系统，是指临床实验室内几个检测系统如临床生化学、免疫学、血液学等检测系统的系统化整合，是将相同或不同的分析仪器与实捡室分析前和分析后系统，通过自动化检验仪器和信息网络连接形成检验及信号处理系统的过程。
室内质量控制是各实验室为了监测和评估本实验室的工作质量，以此决定常规检验报告能否发出所采取的一系列检查控制手段。目前实验室自动化流水线各分析仪器的室内质量控制方案是应用分析仪器质控模块进行控制。在进行室内质量控制时通常遵循相关规定，按照固定时间和次数进行室内质量控制，例如，每天每个检测项目至少运行一次质控,每个项目不少于两个水平。例如，对于某一或某多个项目，按照规定一天进行一次定时质控，如上午九点进行质控，质控结果为在控状态，第二天同一时间点再次进行质控，结果发现质控结果为失控状态，这样可能需要将两次质控之间的病人样本全部进行复检，直至找到受影响的全部样本，不仅耗时费力，降低检测效率，甚至可能会导致病人样本的检测结果出错。
发明内容
有鉴于此，本发明提供一种个性化临床检验质控方法，包括：
获取用户设置信息，所述用户设置信息包括质控项目信息、与所述质控项目信息对应的质控规则信息和质控时间信息；
根据所述质控时间信息启动临床医疗体液检测系统吸取质控品，并对吸取的质控品进行分析得到关于所述质控项目信息的测定值；
按照所述质控规则信息针对所述测定值进行分析，得到关于质控项目的质控结果。
可选地，所述质控时间信息包括间隔时间信息、首次启动时间信息。
可选地，所述用户设置信息还包括跳过时间信息，用于指示所述临床医疗体液检测系统暂停执行质控操作的时间段。
可选地，所述用户设置信息还包括样本批信息，所述样本批信息用于指示数量阈值，在所述临床医疗体液检测系统对达到所述数量阈值的体液样本进行检测时，启动对质控品进行 检测以执行相应的质控项目。
可选地，所述质控项目信息包括质控名称信息和浓度水平信息。
可选地，所述用户设置信息还包括分析仪信息；在根据所述质控时间信息启动临床医疗体液检测系统吸取质控品，并对吸取的质控品进行分析得到关于所述质控项目信息的测定值的步骤中，使所述临床医疗体液检测系统根据所述分析仪信息将装有质控品的储存管传递到相应的分析仪处，使其吸取质控品，并分析得到关于所述质控项目信息的测定值。
可选地，所述用户设置信息还包括最大使用次数；在对吸取的质控品进行分析得到关于所述质控项目信息的测定值后，记录对当前质控品的使用次数，并判断所述使用次数是否达到所述最大使用次数；当所述使用次数达到所述最大使用次数时，控制所述临床医疗体液检测系统丢弃剩余的质控品。
可选地，所述用户设置信息还包括质控品编号；在根据所述质控时间信息启动临床医疗体液检测系统吸取质控品的步骤中，使所述临床医疗体液检测系统根据所述质控品编号从存储模块中取出装有质控品的储存管。
可选地，同一个质控项目信息对应多个不同的质控规则信息。
相应地，本发明提供一种个性化临床检验质控设备，包括：至少一个处理器；以及与所述至少一个处理器通信连接的存储器；其中，所述存储器存储有可被所述一个处理器执行的指令，所述指令被所述至少一个处理器执行，以使所述至少一个处理器执行上述临床医疗体液检测质控方法。
本发明将体液检测系统应用于质量控制，允许用户根据实验室需求设置质控项目、质控时间和质控规则，在录入这些设置信息后，借助该系统的各个模块按时对质控品进行吸取和测量，进而按照预设的质控规则自动得到质控结果，使质控工作实现自动化和个性化，可满足各种临床医疗实验室对质量控制的需求，避免人为操作对质控过程所产生的影响，提高质控工作的效率以及质控结果的准确性。
通过合理设置各个质控项目的时间，可使多个质控项目同时进行，系统吸取一次质控品可执行多个质控项目，并且可以精准控制对质控品的吸取量，由此可以明显节约质控品的用量，降低质控品开销。
附图说明
为了更清楚地说明本发明具体实施方式或现有技术中的技术方案，下面将对具体实施方式或现有技术描述中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图是本发明的一些实施方式，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图获得其他的附图。
图1示出了一种临床医疗体液检测系统的结构示意图；
图2示出了本发明实施例中的个性化临床检验质控方法的示意图；
图3示出了本发明实施例中的自动化临床检验质控方法的示意图；
图4示出了本发明实施例的临床检验质控设备的示意图；
图5是本发明提供的一种质控分析物的储存管的主视图；
图6是本发明提供的一种质控分析物的储存管的俯视图；
图7是本发明提供的管口局部示意图；
图8是本发明提供的一种质控分析物的储存管的优选方案示意图。
具体实施方式
为使本发明实施例的目的、技术方案和优点更加清楚，下面将结合本发明实施例中的附图，对本发明实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例是本发明一部分实施例，而不是全部的实施例。基于本发明中的实施例，本领域技术人员在没有作出创造性劳动前提下所获得的所有其他实施例，都属于本发明保护的范围。
本实施例提供一种临床医疗体液检测质控方法，该质控方法基于临床医疗体液检测系统自动执行质控操作。如图1所示，临床医疗体液检测系统包括检测系统10和数据管理系统20，据管理系统可以为计算机或服务器。检测系统10包括轨道传输模块111以及依次连接在轨道传输模块111上的进样模块11、识别模块12、离心模块13、去盖模块14、去膜模块15、至少一台分析仪器16、封膜模块17、回盖模块18、出样模块19、存储模块112。数据管理系统20与检测系统10进行连接通信，在数据管理系统20中安装有管理系统软件，利用数据管理系统20中的管理系统软件控制操控检测系统工作。
进样模块11将体液样本送入轨道传输模块111，轨道传输模块111将体液样本转移至分析仪，分析仪对体液样本进行抽样检测，分析仪与数据管理系统20连接，分析仪将采集的数据传输至数据管理系统20，数据管理系统20对分析仪采集的数据进行分析处理。
检测系统含有至少一个进样模块11和至少一个出样模块19。进样模块11和出样模块19通过可配置的在轨道输送模块上装载和卸载体液样本试管。其中，进样模块11和出样模块19可以为机械手或者其他用于装载和卸载体液样本其他装置。
离心模块13可以对体液样本进行自动离心分离，去盖模块14可以拆开主样本试管的塑料螺旋盖和压力封盖，去膜摸块可以去除被封膜模块17密封的样本试管密封膜，分杯模块可以通过现有主样本试管产生辅助样本试管。
封膜模块17使用密封门口密封试管。将密封膜切割，然后热封到每个塑料样本试管上。回盖摸块可以将旋盖放在分杯模块产生的辅助样本试管上。储存模块将密封的样本试管保存 在温度受控的环境中，它可以包括存储工作台和自动冷冻机。
下面将结合临床医疗体液检测系统的各个模块对其工作过程进行描述，体液样本盛放在试管中，试管上设置有用于标志该体液样本信息标签，具体的该标签可以为识别码例如二维码或电子标签等，首先，对体液样本进行检测时，由进样模块11将体液样本放置在轨道传输模块111上，由识别模块12识别试管上的标签，识别完成后，如需离心，则进入离心模块13进行自动离心，之后进入去盖模块14或去膜模块15，具体的可以根据试管上密封物进行选择，在完成去盖或去膜后，由轨道传输模块111将样本输送至分析仪，分析仪可以通过试管上的标签识别体液样本信息，分析仪对样本进行吸样分析，之后进入封膜模块17进行封膜，封膜完成后，由轨道传输模块111将体液样本传输至存储模块112，出样模块19将体液样本放回储存模块进行储存。
基于图1所示的临床医学体液检测系统，本发明实施例提供一种个性化临床检验质控方法，本申请所述质控是指临床检验室内质量控制(internal quality control)，本申请中涉及的术语、相关背景技术可参考中华人民共和国国家卫生健康委员会2018年12月11日发布的卫生行业标准《临床检验定量测定室内质量控制》。
如图2所示，本发明实施例提供的方法可以由上述数据管理系统20执行，或者由外接的终端执行。该方法包括如下步骤：
S10A，获取用户设置信。用户设置信息包括质控项目信息、与其对应的质控规则信息和质控时间信息。其中质控项目信息用于表示质控目标，比如质控项目名称或简称，作为一个举例该信息可以是“转氨酶”或者“ALT”。
质控规则是解释质控数据和做出质控状态判断的决策标准，当质控测定值超过质控规则所规定的质控限时，则判断该分析批违背此规则，视为失控。例如可用的质控规则有1 2s、1 3s、2 2s、R 4s、4 1s、10 X，它们的含义不同。以1 2s为例，其含义是当一个质控测定值超过X±2s时，即判断为失控。
质控规则可以由用户主观设定，也可以由系统采集历史质控数据，根据OPSpecs图自动生成合适的质控规则。具体地，系统可采集此前用户手动执行质控并录入的质控结果数据，然后计算针对各个质控项目的sigma度量值，并据项目类型和sigma度量值生成OPSpecs图，通过设定所需的临界系统误差(pfr<5％)和拒绝概率(ped>90％)自动生成适合该项目的质控规则。
并且用户可以为同一个质控项目设置多个不同的质控规则信息，例如针对质控项目A，可允许用户设定同时采用1 2s、1 3s、2 2s等多个质控规则。
质控时间信息用于设定临床医疗体液检测系执行质控操作的时间和/或周期等执行质控 的时机。
S20A，根据质控时间信息启动临床医疗体液检测系统吸取质控品，并对吸取的质控品进行分析得到关于质控项目信息的测定值。启动的方式有多种，例如可以向检测系统发送启动时间，之后检测系统保存这些设置，每当到达启动时间时则开始取样和分析；或者在到达启动时间时向检测系统发出启动指令，唤醒其执行取样和分析。
作为举例，比如某质控项目信息为“转氨酶”，则控制质临床医疗体液检测系统中的分析仪器16吸取质控品，并分析其中的转氨酶含量，即关于质控项目信息的测定值。
S30A，按照质控规则信息针对测定值进行分析，得到关于各个质控项目的质控结果。分析仪器16得到测定值后，将结果发回执行本方法的终端，然后终端按照如1 2s等预先设定的质控规则对其进行分析，得到质控结果，例如在控状态或者失控状态。
结合图1，具体地，为了自动执行质控操作，临床医疗体液检测系统中的储存模块112中预先放置质控品，按照设定的质控时间控制出样模块19在储存模块112中取出质控品，放在轨道传输模块111上进入分析仪器16处，吸取质控品进行分析获得关于质控项目的测定值。然后根据质控规则信息对测定值进行分析，得到质控结果。
执行本方法的终端可向用户呈现交互界面，由用户设置上述信息。终端可以允许用户根据需要添加多个不同的质控项目信息(如酶、离子、蛋白等等)，并分别设置它们的质控时间和质控规则。不同的质控项目的质控时间和质控规则可以是相同或者不同的，具体根据用户需要进行设置。
本发明实施例提供的质控方法将体液检测系统应用于质量控制，允许用户根据实验室需求设置质控项目、质控时间和质控规则，在录入这些设置信息后，借助该系统的各个模块按时对质控品进行吸取和测量，进而按照预设的质控规则自动得到质控结果，使质控工作实现自动化和个性化，可满足各种临床医疗实验室对质量控制的需求，避免人为操作对质控过程所产生的影响，提高质控工作的效率以及质控结果的准确性。
需要说明的是，本发明将临床医学体液检测系统用于执行质控，并不影响其对体液样本进行检测。当检测系统在检测体液样本的过程中达到应当进行质控的时机时，切换为检测质控品即可。具体地，比如图1所示的系统在达到质控时间时，轨道传输模块111上有正在被检测或等待检测的体液样本，此时可以控制该系统完成对这些体液样本的检测，而不再传输未检测的体液样本，检测完成后立即传输质控品执行检测；或者可以控制该系统立即中止对这些样本的检测，将它们传回存储模块112，立即传输质控品执行检测，待质控完成后继续检测体液样本。
在进行质控时，通常需要对一个质控项目进行多个浓度水平的质控操作。作为举例，用 户需要准备一部分白蛋白水平为“1”的质控品，以及另一部分白蛋白水平为“2”的质控品。在一个优选的实施例中，上述质控项目信息包括质控名称信息和浓度水平信息。例如两个质控项目名称信息分别为“白蛋白1”和“白蛋白2”，表示两种水平的白蛋白。
用户可针对这两种水平可设置相同或不同的质控规则和质控时间，例如针对水平信息为“1”的质控品采取规则1 2s，针对水平信息为“2”的质控品采取规则1 2s和规则1 3s。作为示例性的说明，对应关系如下表所示：
Figure PCTCN2020097587-appb-000001
这些信息均由用户设置，或者提供缺省信息并允许用户修改。由此在步骤S20A中，可使检测系统按照time1吸取白蛋白水平为“1”的质控品，得到相应的测定值后，在步骤S30A中按照1 2s分析其质控结果；使检测系统按照time2吸取白蛋白水平为“2”的质控品，得到相应的测定值后，在步骤S30A中按照1 2s和1 3s分析其质控结果。不同水平运行的频率可以是不同的，比如“白蛋白1”的质控规则是1 3s/2 2s/r 4s/6 x，次数为2是指每天需要运行两次质控，而白蛋白2的质控规则是1 3s，次数为1是指每天运行一次质控。
根据上述优选方案可实现多水平自动质控，提高质控结果的质量。
为了实现对多个质控项目进行自动质控，储存模块112中会存有多个储存管，各个储存管可存有相同的质控品，或者不同的质控品(例如浓度水平不同)。为了使出样模块19准确取出质控项目所需的储存管，用户设置信息中还可以包括质控品编号，或称为储存管编号。作为举例，质控品编号与其他信息的对应关系如下：
质控项目信息 储存管编号 质控规则 时间信息
白蛋白 qc01 1 2s time1
转氨酶 qc02 1 2s、1 3s Time2
表示储存管qc01用于白蛋白的质控，所采用的质控规则是1 2s，执行质控的时间是time1。根据这些信息控制如图1所示系统，在time1时出样模块19从存储模块112中取出储存管qc01，通过轨道传输模块111传递到分析仪器16处，吸取储存管qc01中的质控品，得到白蛋白含量的测定值，然后按照12s确定质控结果；在time2时出样模块19从存储模块112中取出储存管qc02，通过轨道传输模块111传递到分析仪器16处，吸取储存管qc02中的质 控品分析得到转氨酶含量的测定值，然后按照1 2s和1 3s确定质控结果。
因此，质控品编号的用途是在步骤S20A中使临床医疗体液检测系统从存储模块中取出质控项目所需的储存管。现有的系统普遍配备扫码装置，质控品编号以条码形式贴在储存管上，在进样时通过扫描条码即可记录储存管的位置，在取样时根据编号即可取出对应的储存管。
由于同一管质控品会被重复使用多次(执行多次质控项目)，为了在质控品用尽或者剩余量过低时自动舍弃质控品，所述用户设置信息中还可以包括最大使用次数。作为举例，最大使用次数与其他信息的对应关系如下：
质控项目信息 储存管编号 最大使用次数 质控规则 时间信息
白蛋白 qc01 7 1 2s time1
转氨酶 qc02 7 1 2s、1 3s time1
表示储存管qc01用于白蛋白的质控，其最大使用次数为7次。在步骤S20A中，每次分析仪16从储存管qc01吸取质控品后，记录对当前质控品(储存管)的使用次数，并判断当前使用次数是否达到最大使用次数7次。当使用次数未达到最大使用次数7次时，临床医疗体液检测系统将储存管qc01通过轨道和进样模块传回存储模块，以备下一次使用；当使用次数达到最大使用次数7次时，临床医疗体液检测系统丢弃剩余的质控品，即丢弃储存管qc01。当用户重新装填质控品、重新启用储存管qc01后，重置记录的使用次数。
在如图1所示的系统中，通常会同时设置多个分析仪16，为了指定某一分析仪16执行某个质控项目，所述用户设置信息中还可以包括分析仪信息。作为举例，分析仪信息与其他信息的对应关系如下：
质控项目信息 储存管编号 分析仪信息 质控规则 时间信息
白蛋白 qc01 C16000-3 1 2s time1
转氨酶 qc02 C16000-2 1 2s、1 3s time1
表示分析仪C16000-3用于执行白蛋白的质控、分析仪C16000-2用于执行转氨酶的质控。根据该信息，在步骤S20A中系统将通过轨道传输模块将储存管qc01传输到分析仪C16000-3处，由该分析仪吸取质控品，并得到白蛋白含量的测定值。
在一个优选的实施例中，用户设置信息中还可包括样本批信息，用于指示检测系统在检测体液样本的过程中启动质控的时机。样本批信息用于表示数量阈值n，在临床医疗体液检测系统连续检测n个体液样时，控制其中止进行体液样本检测，启动对质控品进行检测以执行相应的质控项目。
样本批信息和上述质控时间信息并存，当达到二者任一条件时即开始进行质控。
作为示例性的说明，样本批信息与其他信息的对应关系如下：
质控项目信息 储存管编号 样本批信息 质控规则 时间信息
白蛋白 qc01 n1 1 2s time1
转氨酶 qc02 n2 1 2s、1 3s time1
由此，本方法还包括：监测临床医疗体液检测系统连续检测体液样本或者项目的数量，当该数量达到样本批信息所指示的数量阈值时，启动对质控品进行检测以执行相应的质控项目。比如当系统连续检测n1个体液样本时，启动对质控品进行检测得到白蛋白的测定值，并分析质控结果。
根据上述优选方案，在临床医疗体液检测进行正常工作，即检测患者体液样本时，监测其是否达到样本批信息所指示的质控启动条件，从而自动将其从工作状态切换为质控状态，由此避免其出现失控状态，减小患者样本检测结果出错的概率。
在可选的实施例中，上述质控时间信息具体可包括间隔时间信息，间隔时间例如为几小时；质控时间信息还可以包括首次启动时间信息，表示在一天中第一次执行质控的时间点。作为示例性的说明，上述时间信息与其他信息的对应关系如下：
质控项目信息 储存管编号 质控规则 首次启动时间 间隔时间
白蛋白 qc01 1 2s 6:00 8小时
转氨酶 qc02 1 2s、1 3s 6:00 12小时
根据这些时间信息，在步骤S20A中，在每天6:00启动临床医疗体液检测系统吸取质控品，得到白蛋白的测定值，并分析质控结果。然后每隔8小时重新执行一次白蛋白的质控(每天3次)。
另外，用户设置信息还包括跳过时间信息，用于指示临床医疗体液检测系统暂停执行质控操作的时间段。比如用户可以设置某年某月某日作为跳过时间，在这一天系统不会启动执行质控。
这些信息可以由用户自行设置。根据质控需求，对于不同的质控项目分别设定上述时间信息。
在执行如上述实施例的个性化质控的同时，还可以在检测患者体液样本时实时根据体液样本的检测结果监测该系统是否处于失控状态，一旦发现某个检测项目可能失控，则控制该系统暂停/自动审核/或暂停检测患者样本，转为执行相关的质控项目。具体方法如图3所示，在上述实施例的各个步骤的基础上，该质控方法还可包括如下步骤：
S10B，获取体液样本的至少一个检测项目的检测数据。在本实施例中，体液样本可以包括血液、尿液、组织液。检测项目可以包括体液中的各种酶的检测。例如谷丙转氨酶、丙氨酸转移酶等，以及各种离子的检测，例如，钾、钙、钠等离子。或者其他检测项目，例如，白蛋白，球蛋白等检测项目。示例性的所称的检测数据为患者的检测项目的检测结果。
S20B，对检测数据进行移动均值计算，得到检测项目的移动均值。作为示例性的实施例，移动均值的计算可以采用如下方法：若依次得到测定值为(x 1，x 2，x 3，...，x n)时，按顺序取一定个数所做的全部算术平均值。例如
Figure PCTCN2020097587-appb-000002
可以得到移动平均值。当然，在本实施例中，也可以采用按照顺序取两个数据做平均值。移动均值算法包括多种，例如一次移动平均法或二次移动平均法等等，本发明可以使用任何移动均值算法得到检测项目的移动均值。
S30B，判断检测项目的移动均值是否超过预设阈值。作为示例性的实施例，预设阈值可以根据医院检测样本的检测结果确定预设阈值，在本实施例中，预设阈值可以根据检测得到的检测数据随时变动，可以根据检测移动均值可以按时间顺序对移动均值进行描点，在移动均值的点落入预设阈值内，则认为检测项目的检测数据正常，在移动均值点落入预设阈值外时，则认为该检测项目的检测结果可能存在问题。
为了避免出现随机现象，例如，分析仪在吸取试管中的体液样本时，吸取到气泡等，导致检测数据出现较大的漂移，在示例性的实施例中，在确认移动均值是否超过预设阈值时，可以连续检测多个移动均值是否均超过预设阈值，或者连续检测多个预设阈值中是否存在多个移动均值超过预设阈值的情况，即较短时间内间隔性的出现多个移动均值超过预设阈值的情况。
具体的，判断多个连续体液样本中的检测项目的移动均值超过预设阈值的个数是否大于预设个数；当连续多个体液样本中的移动均值超过预设阈值的个数大于预设个数时，确认移动均值是否超过预设阈值。作为示例性的说明，在出现移动均值超过预设阈值时，为避免出现随机情况，可以在第一个出现超过预设阈值的移动均值开始，可以连续观测后续的两个或三个移动均值是否均超出预设阈值，如果从第一个超出预设阈值的移动均值开始连续出现了两个或三个移动均值超出预设阈值的状况，可以确认当前检测项目的移动均值超标，输出提示信息。例如可以在临床医疗体液检测的操作屏幕上显示某一项目的检测可能存在某种问题，或者输出语音提示等。
作为另一可选的实施例，在第一个出现超过预设阈值的移动均值开始，连续观测后续的 五个移动均值中是否有超过两个超出预设阈值的移动均值，在超过两个时，确认当前检测项目的移动均值超标，输出提示信息。本领域技术人员应当明白上述实施例中的移动均值的个数只是为了方便说明而进行的举例，其他个数的移动均值也在本实施例的保护范围内。当检测项目的移动均值超过预设阈值时，进入步骤S40B，当检测项目的移动均值在预设范围内，返回步骤S10B。
S40B，控制临床医疗体液检测系统对检测项目进行质控。具体地，预先在临床医疗体液检测系统中的储存模块中放置质控品(也称质控分析物)，在检测项目的移动均值超过预设阈值后，控制出样模块19在储存模块中取出质控品，放在轨道传输模块111上进入分析仪，进行移动均值超出预设阈值的对应的检测项目的质控分析。
作为示例性的实施例，如图1所示，轨道传输模块111可以包括急诊通道113，在检测项目的移动均值超过预设阈值时，可以控制质控品进入急诊通道113优先进入分析仪进行质控，以在最短的时间内完成当前检测项目的质控。
作为示例性的实施例，当检测项目的移动均值超过预设阈值时，继续对体液样本进行检测，并将确认移动均值失控时具有检测项目的后续体液样本标注待查标签。具体的，可以将该待查标签与体液样本的识别标签关联。由于移动均值超出预设阈值时，并不能完全确认该检测项目失控，因此，可以先继续对样本进行正常检测，以免影响检测效率。
作为另一示例性的实施例，当检测项目的移动均值超过预设阈值时，控制临床医疗体液检测系统对检测项目下线，所称的检测项目下线可以为停止当前的分析仪进样。具体的，可以停止具有该检测项目的体液样本进入当前的分析仪。在本实施例中，在停止进入当前分析仪后，将具有该检测项目的体液样本输送至其他在线的分析仪继续进行吸样检测。
作为示例性的实施例，在某一检测项目的移动均值超过预设阈值时，质控品通过急诊通道113进入该检测项目对应的分析仪后，控制分析仪器16按预设质控规则在质控品中采集与该检测项目相应的室内质控数据，并对室内质控数据进行分析。具体的，不同的检测项目对应的质控规则是根据实际情况可以在六西格玛sigma规则中选择至少一个规则进行质控，其中质控规则可以包括:1 3s、2 2s、3 2s、r 4s、6 x、8 x、9 x、10 x、1 5s等。
控制规则以1 3s为例，在室内质控数据超过质控规则1 3s时，判定质控结果为失控，在质控结果为失控时，对当前检测项目的体液样本进行复检，具体的，如果在检测项目的移动均值超过预设阈值时，分析仪继续进样检测，则可以对具有待查标签的体液样本进行复检。由于在移动均值第一次超过预设阈值时，为防止出现随机事件，在连续多个体液样本中的移动均值超过预设阈值的个数大于预设个数时，才对后续的样本进行标注，因此，只对带有待查标签的体液样本进行复检，可能会出现遗漏，所以也需要对出现移动均值超过预设阈值的体 液样本之前的几个样本也进行复检。具体的，对移动均值第一次超过预设阈值时的样本至通过采用质控品进行质控，并得到质控结果为失控时之间的所有样本都进行复检。
本发明实施例还提供了一种临床检验质控设备，包括：至少一个处理器；以及与至少一个处理器通信连接的存储器；其中，存储器存储有可被一个处理器执行的指令，指令被至少一个处理器执行，以使至少一个处理器执行上述临床医疗体液检测质控方法。
具体的，如图4所示，上述临床医疗体液检测质控设备100包括一个或多个处理器102、一个或多个存储装置104。可选地，电子设备100还可以包括输入装置106、输出装置108，这些组件通过总线系统110和/或其它形式的连接机构(未示出)互连。应当注意，图4所示的电子设备100的组件和结构只是示例性的，而非限制性的，根据需要，电子设备也可以具有其他组件和结构。
处理器102可以采用数字信号处理(DSP)、现场可编程门阵列(FPGA)、可编程逻辑阵列(PLA)中的至少一种硬件形式来实现，处理器102可以是中央处理单元(CPU)、图像处理器(GPU)、专用的集成电路(ASIC)或者具有数据处理能力和/或指令执行能力的其它形式的处理单元中的一种或几种的组合，并且可以控制电子设备100中的其它组件以执行期望的功能。
存储装置104可以包括一个或多个计算机程序产品，计算机程序产品可以包括各种形式的计算机可读存储介质，例如易失性存储器和/或非易失性存储器。易失性存储器例如可以包括随机存取存储器(RAM)和/或高速缓冲存储器(cache)等。非易失性存储器例如可以包括只读存储器(ROM)、硬盘、闪存等。在计算机可读存储介质上可以存储一个或多个计算机程序指令，处理器102可以运行程序指令，以实现上述本发明实施例中(由处理器实现)的客户端功能以及/或者其它期望的功能。在计算机可读存储介质中还可以存储各种应用程序和各种数据，例如应用程序使用和/或产生的各种数据等。
输入装置106可以是用户用来输入指令的装置，并且可以包括键盘、鼠标、麦克风和触摸屏等中的一个或多个。
输出装置108可以向外部(例如用户)输出各种信息(例如图像和/或声音)，并且可以包括显示器、扬声器等中的一个或多个。可选地，输入装置106和输出装置108可以集成在一起，采用同一交互装置(例如触摸屏)实现。
示例性地，用于实现根据本发明实施例的临床医疗体液检测质控电子设备可以在诸如个人计算机或远程服务器等的设备上实现。
本发明实施例提供一种临床医疗质控系统，包括：临床医疗体液检测系统以及上述质控设备，该设备与临床医疗检测系统通信连接。需要说明的是，临床医疗体液检测系统不限于图1所示结构，现有的检测系统有多种，只要具备自动对质控品进行抽样和分析功能的检测 系统都是可行的。
在优选的实施例中，质控系统还包括移动终端，例如通用智能手机或专用掌上电脑(PDA，Personal Digital Assistant)。质控设备向移动终端发送质控结果，使远程用户及时了解质控状态。或者，移动终端可以和质控设备配合执行上述质控方法，比如质控设备用于控制临床医疗体液检测系统，即根据步骤S10A中的部分信息执行步骤S20A，而移动终端用于确定质控结果，即根据步骤S10A中的部分信息执行步骤S30A。
在可选的实施例中，移动终端用于发送质控控制指令，例如重启、暂停等等。这可以使远程用户根据质控状态控制质控设备，比如在出现失控情况时，可以发送指令使质控设备重新执行上一次的质控操作，对失控情况进行验证等等。
本领域内的技术人员应明白，本发明的实施例可提供为方法、系统、或计算机程序产品。因此，本发明可采用完全硬件实施例、完全软件实施例、或结合软件和硬件方面的实施例的形式。而且，本发明可采用在一个或多个其中包含有计算机可用程序代码的计算机可用存储介质(包括但不限于磁盘存储器、CD-ROM、光学存储器等)上实施的计算机程序产品的形式。
这些计算机程序指令也可存储在能引导计算机或其他可编程数据处理设备以特定方式工作的计算机可读存储器中，使得存储在该计算机可读存储器中的指令产生包括指令装置的制造品，该指令装置实现在流程图一个流程或多个流程和/或方框图一个方框或多个方框中指定的功能。
这些计算机程序指令也可装载到计算机或其他可编程数据处理设备上，使得在计算机或其他可编程设备上执行一系列操作步骤以产生计算机实现的处理，从而在计算机或其他可编程设备上执行的指令提供用于实现在流程图一个流程或多个流程和/或方框图一个方框或多个方框中指定的功能的步骤。
如图5和图6所示，本发明实施例提供了一种质控分析物的储存管，用于储存上述质控品。该储存管包括由上至下依次连接的管口1、上部管体2和下部底座4；所述管口1、上部管体2和下部底座4；所述管口1，由管壁环绕而成，从所述上部管体2到所述管口1，管壁的厚度逐渐变薄。优选地，所述上部管体2和所述管口1与所述上部管体2连接处的管壁厚度为0.8mm，所述管口1的顶部的管壁厚度为0.1mm，所述管口1的长度为6mm，所述管口1的半径为12mm，在所述管口1的上部可以添加盖或者膜，使其在出厂时符合医疗领域对无菌环境的要求。
所述上部管体2，由管壁环绕而成，在所述上部管体2内部形成中部腔体3，所述中部腔体3上部与外界连通，所述中部腔体3下部与所述下部底座4接触，所述中部腔体3用于存放质控品。优选地，在中部腔体3内部添加一个或多个磁力混匀珠，使其在流水线(相当 于上述临床医学体液检测系统)上能够进行磁力混匀；所述上部管体2的管壁厚度为0.8mm，所述上部管体2的长度为75mm或者100mm。所述下部底座4，外部为上宽下窄的圆台形结构，内部为圆柱形的底部腔体5；所述底部腔体5上端与所述下部底座4的外壁接触，所述底部腔体5下端与外界联通。
如图7所示，所述管口1的内壁均匀分布有四个加强筋6，使管口1不易损坏。具体地，流水线封膜时会对管口1施加一个下压力，由于本实施例中的管口1厚度很薄，这有可能在受到下压力的时候变形或破碎，为了加固管口1使其不被流水线的封膜装置损坏，而可以在管口1处设置若干加强筋。在其他实施例中，加强筋也可以设置在管口1的外壁上。因为一些应用场景下，所述储存管有盖子，所述加强筋6在内壁上会导致不能加塞子或者密封不严，因此加强筋优选为设置在外壁上。
进一步地，所述储存管的材料中含有玻璃纤维，能够使管体变硬，不易在受到下压力时变形。
图8同时提供了三种优选方案，所述底部腔体5中设置有填充体7，某些品牌的流水线上的安置所述储存管的底座，在检测过程中需要把所述储存管从所述底座上顶起来，如果所述底部腔体5内为空心，那么所述底座上的顶针就无法将所述储存管顶起，因此需要在所述底部腔体5中设置有所述填充体7，使得所述底座的顶针能把整个所述储存管顶起来。
第一种可选方案，所述填充体7为短柱，所述短柱上部与所述底部腔体5的上端中心连接，所述短柱半径小于所述底部腔体5半径，所述短柱用途是配合自动生化检测流水线。
第二种可选方案，所述填充体7由电池、电磁开关和马达组成。这种设置是为了使所述储存管能够震动或晃动，从而对所述储存管内质控分析物进行混匀。具体是在流水线上设置一个相应的磁力开关，当所述储存管经过开关时(可响应到流水线的磁力开关发出的信号)，触发所述填充体7中的所述电磁开关，使得所述马达短暂地运转，使所述储存管随之短暂震动，从而实现混匀操作。流水线上的磁力开关可以设置在分析仪器16之前的任何一个模块处，使储存管在到达分析仪器16之前完成混匀。
可选的，所述底部腔体5和所述中部腔体3分体设置，所述下部底座4和所述上部管体2之间用插接或螺纹连接等可拆卸地连接，这样使带有所述马达的所述下部底座4可以被反复使用，所述上部管体2使用后可以废弃。
第三种可选方案，管口1外壁由下至上逐渐向内收缩，保持布置有所述加强筋6的地方与所述上部管体2的中部直径一致。
具体实施过程：储存管从冰箱进入到流水线，流水线上设置一个相应的磁力开关，当所述储存管经过所述磁力开关时，触发所述填充体7中的所述电磁开关，使得所述马达短暂地 运转，使所述储存管随之短暂震动，从而实现混匀操作；然后进入开盖模块，所述管口1有盖子，初始是螺纹拧紧的盖子，流水线第一次取样时会把盖子拧掉；然后进入分析模块，流水线底座上的顶针顶入所述底部腔体5内与所述填充体7接触，将所述储存管顶起，由取样针伸如中部腔体3，供分析仪进行质控分析；取样完成后进入封膜模块，在所述管口1封上一个膜，膜的材料一般是铝箔等软性金属材质，并且表面有胶，流水线靠下压力把膜粘在所述管口1上；最后封膜后的储存管回到冰箱中。
质控需要周期性的进行，也就是上述流程需要每周执行几次，甚至每天执行几次。因此就会频繁的对所述储存管进行封膜、揭膜。所述管口1的顶部管壁厚度仅为0.1mm，因此与膜的接触面积较小，在频繁操作中封膜也不会存在揭不下来的情况。
虽然结合附图描述了本发明的实施例，但是本领域技术人员可以在不脱离本发明的精神和范围的情况下作出各种修改和变型，这样的修改和变型均落入由所附权利要求所限定的范围之内。

Claims (10)

  1. 一种个性化临床检验质控方法，其特征在于，包括：
    获取用户设置信息，所述用户设置信息包括质控项目信息、与所述质控项目信息对应的质控规则信息和质控时间信息；
    根据所述质控时间信息启动临床医疗体液检测系统吸取质控品，并对吸取的质控品进行分析得到关于所述质控项目信息的测定值；
    按照所述质控规则信息针对所述测定值进行分析，得到关于质控项目的质控结果。
  2. 根据权利要求1所述的质控方法，其特征在于，所述质控时间信息包括间隔时间信息、首次启动时间信息。
  3. 根据权利要求1所述的质控方法，其特征在于，所述用户设置信息还包括跳过时间信息，用于指示所述临床医疗体液检测系统暂停执行质控操作的时间段。
  4. 根据权利要求1所述的质控方法，其特征在于，所述用户设置信息还包括样本批信息，所述样本批信息用于指示数量阈值，在所述临床医疗体液检测系统对达到所述数量阈值的体液样本进行检测时，启动对质控品进行检测以执行相应的质控项目。
  5. 根据权利要求1所述的质控方法，其特征在于，所述质控项目信息包括质控名称信息和浓度水平信息。
  6. 根据权利要求1所述的质控方法，其特征在于，所述用户设置信息还包括分析仪信息；在根据所述质控时间信息启动临床医疗体液检测系统吸取质控品，并对吸取的质控品进行分析得到关于所述质控项目信息的测定值的步骤中，使所述临床医疗体液检测系统根据所述分析仪信息将装有质控品的储存管传递到相应的分析仪处，使其吸取质控品，并分析得到关于所述质控项目信息的测定值。
  7. 根据权利要求1所述的质控方法，其特征在于，所述用户设置信息还包括最大使用次数；在对吸取的质控品进行分析得到关于所述质控项目信息的测定值后，记录对当前质控品的使用次数，并判断所述使用次数是否达到所述最大使用次数；当所述使用次数达到所述 最大使用次数时，控制所述临床医疗体液检测系统丢弃剩余的质控品。
  8. 根据权利要求1所述的质控方法，其特征在于，所述用户设置信息还包括质控品编号；在根据所述质控时间信息启动临床医疗体液检测系统吸取质控品的步骤中，使所述临床医疗体液检测系统根据所述质控品编号从存储模块中取出装有质控品的储存管。
  9. 根据权利要求1所述的质控方法，其特征在于，同一个质控项目信息对应多个不同的质控规则信息。
  10. 一种个性化临床检验质控设备，其特征在于，包括：至少一个处理器；以及与所述至少一个处理器通信连接的存储器；其中，所述存储器存储有可被所述一个处理器执行的指令，所述指令被所述至少一个处理器执行，以使所述至少一个处理器执行如权利要求1-9中任意一项所述的临床医疗体液检测质控方法。
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