POCT detection item management system and method
By designing a POCT testing project management system, including information interaction and closed-loop management, the problem of ignoring outliers and critical values in POCT testing was solved, thereby improving the accuracy and efficiency of test results.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- VIRTUE DIAGNOSTICS (SUZHOU) CO LTD
- Filing Date
- 2026-04-02
- Publication Date
- 2026-08-04
AI Technical Summary
Existing POCT testing systems lack effective alarm mechanisms for outliers and critical values, which makes test results easily overlooked. Quality control management is not systematic enough, affecting the accuracy and efficiency of test results.
A POCT testing project management system was designed, including a data acquisition module, a testing module, a processing center, an alarm module, and a quality control management module. This system enables information interaction and closed-loop management, triggers different alarm information by setting thresholds, and performs regular quality control management to ensure the accuracy and timeliness of the testing equipment.
It improves the accuracy and efficiency of POCT test results, ensures that outliers and critical values are handled in a timely manner, reduces the risk of test results being overlooked, and achieves systematic quality control management.
Smart Images
Figure CN121964118B_ABST
Abstract
Description
Technical Field
[0001] This invention belongs to the field of medical information processing technology, specifically relating to a POCT testing project management system and method. Background Technology
[0002] Point-of-care testing (POCT) devices are testing methods performed near or at the patient's location, whose results may alter the patient's course of care. Due to their speed, convenience, and ease of operation, they can be used in various emergency medicine settings, including pre-hospital emergency care, in-hospital emergency departments, and EICUs. Chest pain is a common chief complaint in pre-hospital emergency care and emergency department visits. Acute coronary syndrome (ACS) often presents with acute chest pain and is accompanied by a high risk of death. Common applications of POCT in acute cardiovascular events include the rapid detection of myocardial markers and coagulation function related to acute cardiovascular and cerebrovascular diseases. Myocardial markers are proteins or enzymes released into the bloodstream when the myocardium is injured. There are many types of myocardial markers, and they play a crucial role in the auxiliary diagnosis of acute and critical cardiovascular diseases in the emergency department.
[0003] Currently, point-of-care testing (POCT) of cardiac markers is mostly performed by clinical medical staff. However, factors such as incomplete information exchange between departments affect the accuracy and reproducibility of POCT results for cardiac markers.
[0004] Due to the high quality control standards, short completion timeframes, complex workloads for clinical medical staff, and difficulties in collecting relevant data, the current management system for POCT equipment suffers from the following problems: There is a lack of effective alarm and closed-loop notification mechanisms for abnormal and critical values in POCT testing, which can easily lead to overlooked results and delayed handling. Furthermore, the POCT testing equipment lacks systematic and refined quality control management methods, and the efficiency and accuracy of test results need improvement.
[0005] Therefore, there is an urgent need to provide a POCT testing project management system and method that can systematically manage the information collected by POCT equipment, improve work efficiency, and reduce error rate. Summary of the Invention
[0006] In order to solve at least one of the above-mentioned technical problems in the prior art, the present invention provides a POCT testing project management system and method.
[0007] To achieve the above objectives, the technical solution of the present invention is as follows:
[0008] In a first aspect, the present invention provides a POCT testing project management system, comprising: The acquisition module is used to acquire the sample to be tested; The detection module is used to detect samples and send the detection results to the processing center; The processing center is used to receive test results and issue test reports based on the test results; The processing center can interact with the hospital information system and the laboratory information system. The processing center includes an alarm module and a quality control management module; The alarm module is used to provide alarm prompts based on a set threshold. The quality control management module is used to manage the quality control of the testing module.
[0009] Furthermore, the acquisition module is a POCT device.
[0010] Furthermore, the alarm module includes a first alarm module and a second alarm module. The first alarm module acquires the detection result. If the detection result is not within the first trigger range and not within the second trigger range, the first alarm information is triggered. The second alarm module acquires the detection result. If the detection result is within the second trigger range, it triggers the second alarm message.
[0011] The first trigger range is the normal range of the item to be tested; if the result exceeds the first trigger range, the test result is positive. The second trigger range is a larger range that covers the first trigger range, such as troponin I 99. th The threshold value is 0.03 µg / L. Values greater than 0.03 µg / L are considered critical, and values greater than 0.15 µg / L can be used to diagnose acute myocardial infarction. Therefore, the first trigger range is less than 0.03 µg / L, and the second trigger range is greater than 0.15 µg / L.
[0012] The first alarm message can be indicated by a yellow light, and the second alarm message can be indicated by a red light, to remind medical staff to collect the report in a timely manner.
[0013] Secondly, this invention provides a POCT testing project management method, used in conjunction with the aforementioned POCT testing project management system, the method comprising: Step 1: Connect the port of the detection module to the processing center; Step 2: Load the hospital information system and laboratory information system onto the processing center; Step 3: The processing center establishes testing items based on patient information; Step 4: Use the detection module to detect the sample to be tested, and the processing center obtains the test results; Step 5: The processing center issues an electronic test report based on the patient information, test items, and test results; Step 6: The processing center will transmit the electronic test report to the hospital information system.
[0014] Furthermore, the method also includes: Step 7: The processing center obtains the detection values from the detection results and judges each detection value. If a detection value is not within the first trigger range of the corresponding detection item, and is not within the second trigger range of the corresponding detection item, then the first alarm information is triggered. If a certain detection value falls within the second trigger range corresponding to that detection item, then the second alarm message is triggered; If all test values are normal, the timeline of the test items is obtained, and the time T from the start of the test to the completion of the electronic test report is calculated. If the time T is greater than the set time threshold, the third alarm information is triggered.
[0015] Furthermore, if a second alarm is triggered, the processing center will send the alarm information to the medical staff's mobile device. Once the medical staff disables the alarm notification on their mobile device, the second alarm will be deactivated.
[0016] Furthermore, the method also includes: Step 8: Perform quality control management on the detection module according to the set frequency, specifically including: S81. Obtain n quality control samples with different concentration levels and use the detection module to detect the quality control samples; S82. Obtain the test results of the quality control products and determine the accuracy of the testing module based on the test results; S83. Obtain the detection timeline of the quality control product and determine the timeliness of the detection module based on the detection timeline; S84. Determine whether the detection module is out of control based on accuracy and timeliness.
[0017] Furthermore, the test results of the quality control samples are obtained, and the accuracy of the testing module is judged based on the test results; specifically including: The quality control samples used at the same time were set to different concentrations, arranged in descending order of concentration, and labeled as a quality control sample set. Each quality control item in the quality control set is tested, and the test results of the quality control set are obtained and marked as the test set. The order of the test results in the test set corresponds to that in the quality control set; Obtain the detection result threshold corresponding to each concentration of quality control material, compare each detection result in the detection set with the corresponding detection result threshold, and if more than two detection results are not within the detection result threshold range, it indicates that the detection equipment is out of control.
[0018] Furthermore, when the testing equipment is under control, the average value of the test result threshold corresponding to each quality control item in the quality control set is normalized, and the normalized average value is plotted in a two-dimensional coordinate system; each test result in the test set is normalized, and the normalized test result is plotted in a two-dimensional coordinate system. Obtain the average value of the detection result threshold and the difference between the detection results for each quality control item. Calculate the dispersion of all differences. If the dispersion is greater than the dispersion threshold, the current detection equipment is out of control.
[0019] Furthermore, when the detection equipment is under control, and there is a detection result in the detection set that is not within the detection result threshold range; The obtained dispersion is weighted, and the weight coefficients are obtained as follows: Calculate the relative error of the detection set Specifically, this involves: calculating the average value K of the normalized detection results; and calculating the detection set... The average value of the upper and lower limits of the threshold for each corresponding detection result Where i takes values from 1 to n, and n is the quantity of quality control products, then calculate... The average value B; the relative error is calculated using the following formula. :
[0020] Calculate the difference between the detection results that are outside the detection result threshold range and the average of the upper and lower limits of the corresponding detection result threshold. Then the weighting coefficient for:
[0021] In the above formula, A is calculated as follows: first, obtain the upper and lower limits of the detection result threshold corresponding to the detection result that is not within the detection result threshold range, calculate the average value X of the upper and lower limits of the detection result threshold, and then calculate the average value of the detection result that is not within the detection result threshold range and the average value X. Calculated weighting coefficients Multiply by the original dispersion Then combine with the original dispersion The weighted dispersion is obtained by adding them together. Using the weighted dispersion The detection equipment is compared with the dispersion threshold to determine whether it is out of control; the specific formula is:
[0022] in This represents the weighted dispersion. This represents the original dispersion.
[0023] Furthermore, the testing timeline of the quality control samples is obtained, and the timeliness of the testing module is determined based on the testing timeline. This specifically includes: The detection time of the quality control product is obtained according to the set cycle, and the detection time of multiple cycles is plotted as a time axis. A first time threshold range and a second time threshold range are set, wherein the first time threshold range is within the second time threshold range. Determine the number of time values within the time axis that exceed the first time threshold range. If two or more consecutive time values exceed the upper limit of the first time threshold range, or two or more consecutive time values are lower than the lower limit of the first time threshold range, the detection device is out of control and recorded as the first out of control; otherwise, continue to make judgments. Determine the number of time values within the time axis that exceed the second time threshold range. If one or more time values exceed the second time threshold range, the detection device is out of control and is recorded as the second out of control. Otherwise, continue the judgment process. The system determines the number of time values within the time axis that exceed the first time threshold range. If there is a time value that exceeds the upper limit of the first time threshold range and there is also a time value that is below the lower limit of the first time threshold range, the detection device is out of control and is recorded as the third out of control. Otherwise, the detection device is under control.
[0024] Furthermore, the system determines the number of time values within the time axis that exceed a first time threshold. If a time value exceeds the upper limit of the first time threshold, or if a time value falls below the lower limit of the first time threshold, the test results for the quality control sample within that time period are obtained. Each test result is compared with the corresponding test result threshold. If two or more of the test results of the quality control products corresponding to the 10 time values adjacent to the time anomaly are not within the test result threshold range, it indicates that the testing equipment is out of control; or, if the test result of the quality control product corresponding to the time anomaly is not within the test result threshold range, it is determined that the testing equipment is out of control.
[0025] Furthermore, step eight also includes: S85. Based on the results of the loss of control, determine the cause of the loss of control, specifically as follows: If it is the first instance of loss of control, then it is a systematic error, and the detection equipment needs to be repaired. If it is the second type of out-of-control, it is due to random error or systematic error. In addition to repairing the equipment, it is also necessary to replace the quality control products and retest. If the third out-of-control item is found, it is due to random error and the quality control material needs to be replaced and retested.
[0026] Furthermore, the method also includes: Step 8: Perform quality control management on the detection module according to the set frequency, specifically including: Step 81: Obtain n quality control samples with different concentration levels and use the detection module to detect the quality control samples; Step 82: Obtain the test results of multiple quality control samples according to the set frequency; Step 83: Based on the set time, obtain the test results of all quality control products within the set time period; Step 84: Based on the test results of all quality control products within the set time, determine whether the testing module is out of control.
[0027] Furthermore, step eight also includes: S85. Based on the out-of-control result, determine whether the detection value in step S7 needs to be corrected.
[0028] Compared with the prior art, the present invention has the following beneficial effects: The POCT testing project management system and method provided by this invention interconnects the processing center with the hospital information system to achieve information exchange. This enables closed-loop processing based on the patient's electronic information, eliminating the need for manual data entry by medical staff and ultimately generating a complete electronic report, providing fundamental data for accurate and timely diagnosis and treatment of patients. Furthermore, this application includes an alarm function that issues different alarm messages when abnormal or critical values occur, reminding medical staff to report them promptly. It also alerts doctors via mobile devices to pay attention to alarm items, achieving closed-loop management and preventing abnormal results from being overlooked.
[0029] This invention also ensures the timeliness of testing equipment and the accuracy of test results through detailed quality control measures, ensuring timely and accurate test results. Verification has shown that using the quality control management system of this invention greatly improves testing efficiency. Attached Figure Description
[0030] Figure 1 This is a block diagram of the POCT testing project management system provided by the present invention.
[0031] Figure 2 The flowchart of the POCT testing project management method provided by the present invention.
[0032] Figure 3 This is a quality control chart for the high-concentration group in April in Embodiment 3 of the present invention, where X represents the mean line, -1SD represents the lower limit of the first range, +1SD represents the upper limit of the first range, -2SD represents the lower limit of the second range, +2SD represents the upper limit of the second range, -3SD represents the lower limit of the third range, and +3SD represents the upper limit of the third range.
[0033] Figure 4This is a quality control chart for the low-concentration group in April in Embodiment 3 of the present invention, where X represents the mean line, -1SD represents the lower limit of the first range, +1SD represents the upper limit of the first range, -2SD represents the lower limit of the second range, +2SD represents the upper limit of the second range, -3SD represents the lower limit of the third range, and +3SD represents the upper limit of the third range.
[0034] Figure 5 This is a quality control chart for the high-concentration group in February in Embodiment 3 of the present invention, where X represents the mean line, -1SD represents the lower limit of the first range, +1SD represents the upper limit of the first range, -2SD represents the lower limit of the second range, +2SD represents the upper limit of the second range, -3SD represents the lower limit of the third range, and +3SD represents the upper limit of the third range.
[0035] Figure 6 This is a quality control chart for the low concentration group in February in Embodiment 3 of the present invention, where X represents the mean line, -1SD represents the lower limit of the first range, +1SD represents the upper limit of the first range, -2SD represents the lower limit of the second range, +2SD represents the upper limit of the second range, -3SD represents the lower limit of the third range, and +3SD represents the upper limit of the third range. Detailed Implementation
[0036] The technical solution of the present invention will be clearly described below with reference to the accompanying drawings. Obviously, the described embodiments are not all embodiments of the present invention. All other embodiments obtained by those skilled in the art without creative effort are within the protection scope of the present invention.
[0037] It should be noted that, unless otherwise specifically stated, the relative arrangement and numerical expressions of the components and steps described in these embodiments should not be construed as limiting the scope of the invention.
[0038] The following description of exemplary embodiments is merely illustrative and is not intended to limit the invention or its application or use in any way. Techniques, methods, and apparatus known to those skilled in the art may not be discussed in detail herein, but where applicable, such techniques, methods, and apparatus should be considered part of this specification.
[0039] Example 1 This embodiment provides a POCT testing project management system, such as Figure 1 As shown, it includes: The acquisition module is used to acquire the sample to be tested; The detection module is used to detect samples and send the detection results to the processing center; The processing center is used to receive test results and issue test reports based on the test results; The processing center can interact with the hospital information system and the laboratory information system. The processing center includes an alarm module and a quality control management module; The alarm module is used to provide alarm prompts based on a set threshold. The quality control management module is used to manage the quality control of the testing module.
[0040] The processing center of the POCT testing management system can be a computer or other data processing terminal. The processing center's machine ports are connected to the Hospital Information System (HIS) and Laboratory Information System (LIS) to achieve information exchange, allowing patient information to be recorded directly at the processing center. Emergency patients who have not yet registered can manually create a request in the processing center's LIS system, complete the information, and select the tests according to the doctor's orders. This solves the problem of inconsistent patient test result numbers and avoids confusion regarding patient results.
[0041] In addition, after the processing center achieves information exchange with the HIS and LIS systems, the tested data can be transmitted to the LIS system, and the LIS system and HIS system can transmit reports. Finally, the test results are uploaded to the hospital server, and patients can check the test results through their mobile terminals, which is convenient and fast, and there is no need for paper reports.
[0042] The acquisition module is a POCT (Point-of-Care Testing) device. Using a POCT device for rapid sample acquisition is suitable for situations requiring quick sample collection and test results, such as emergency rooms or chest pain centers.
[0043] The alarm module includes a first alarm module and a second alarm module. The first alarm module acquires the detection result. If the detection result is not within the first trigger range and not within the second trigger range, it triggers a first alarm message. The second alarm module acquires the detection result. If the detection result is within the second trigger range, it triggers a second alarm message.
[0044] The first trigger range is the normal range of the item to be tested; if the result exceeds the first trigger range, the test result is positive. The second trigger range is a larger range that covers the first trigger range, such as troponin I 99. th The threshold value is 0.03 µg / L. Values greater than 0.03 µg / L are considered critical, and values greater than 0.15 µg / L can be used to diagnose acute myocardial infarction. Therefore, the first trigger range is less than 0.03 µg / L, and the second trigger range is greater than 0.15 µg / L.
[0045] The first alarm message can be a yellow light, and the second alarm message can be a red light, used to remind medical staff to collect reports promptly. Alternatively, the first alarm message can be set to an audio alert, and the second alarm message can be set to different audio alerts for easier differentiation.
[0046] Example 2 This embodiment provides a POCT testing project management method, which is used in conjunction with the aforementioned POCT testing project management system, such as... Figure 2 As shown, the method includes: Step 1: Connect the port of the detection module to the processing center; Step 2: Load the hospital information system and laboratory information system onto the processing center; Step 3: The processing center establishes testing items based on patient information; After a patient visits the doctor, the doctor issues an examination order. The nurse scans the order, collects a blood sample using a collection module, and then attaches a patient information tag to the blood collection tube. This links the patient information with the blood sample, and the processing center automatically obtains the collection time.
[0047] Step 4: Use the detection module to detect the sample to be tested, and the processing center obtains the test results; The LIS system scans the patient information tag on the blood collection tube, establishes a corresponding test number, and generates the test number automatically, avoiding the problem of inconsistent numbering. Then, the blood sample is placed into the testing module for automatic testing.
[0048] Step 5: The processing center issues an electronic test report based on the patient information, test items, and test results; Step 6: The processing center will transmit the electronic test report to the hospital information system.
[0049] The electronic test report is automatically transmitted to the LIS system, where doctors can view the test results. Even if medical staff do not retrieve the report in time, doctors can still view it themselves.
[0050] Step 7: The processing center obtains the detection values from the detection results and judges each detection value. If a detection value is not within the first trigger range of the corresponding detection item, and is not within the second trigger range of the corresponding detection item, then the first alarm information is triggered. If a certain detection value falls within the second trigger range corresponding to that detection item, then the second alarm message is triggered; Table 1 shows some of the detection values for troponin. The first trigger range for troponin is less than 0.03 µg / L; the second trigger range is greater than 0.15 µg / L.
[0051] Table 1. Partial Detection Values of Troponin
[0052] Table 1 illustrates that the processing center can determine whether a patient's test results are critical or positive based on the alarm type, thus prompting medical staff to take immediate action.
[0053] If medical staff do not collect reports in a timely manner, and doctors do not review test results promptly, the handling of abnormal test results may be overlooked. Therefore, an alarm reminder function is set up. The first alarm is triggered based on whether the test result is abnormal, i.e., whether it exceeds the normal range. The second alarm is triggered based on critical values. When the second alarm is triggered, the nurse can directly add an item in the system, enter the corresponding number, and the machine will automatically perform a retest. At the same time, the processing center sends the alarm information to the medical staff's mobile device. The second alarm is deactivated after the medical staff turns off the alarm notification on the mobile device. The alarm information includes the time when the critical value data was generated, the name and time of the handling nurse, the name and time of the doctor who received and processed the data, the retest time, and the retest result.
[0054] If all test values are normal, the timeline of the test items is obtained, and the time T from the start of the test to the issuance of the electronic test report is calculated. If time T is greater than the set time threshold, a third alarm is triggered. The time threshold is set according to requirements, for example, 20 minutes.
[0055] The processing center can automatically acquire the time of each stage in the testing process and calculate the time T from the start of the test to the issuance of the electronic test report, as shown in Table 2. The time T is obtained by subtracting the doctor's order time from the result time in Table 2. Finally, the processing center can remind whether the overall time T is greater than the time threshold of 20 minutes.
[0056] Table 2 Example of sampling time detection
[0057] Step 8: Perform quality control management on the detection module according to the set frequency, specifically including: S81. Obtain n quality control samples with different concentration levels and use the detection module to detect the quality control samples; S82. Obtain the test results of the quality control products and determine the accuracy of the testing module based on the test results; S83. Obtain the detection timeline of the quality control product and determine the timeliness of the detection module based on the detection timeline; S84. Determine whether the detection module is out of control based on accuracy and timeliness.
[0058] This includes obtaining the test results of quality control samples and judging the accuracy of the testing module based on the test results; specifically, it includes: The quality control samples used at the same time were set to different concentrations, arranged in descending order of concentration, and labeled as a quality control sample set. Each quality control item in the quality control set is tested, and the test results of the quality control set are obtained and marked as the test set. The order of the test results in the test set corresponds to that in the quality control set; Obtain the detection result threshold corresponding to each concentration of quality control material. Compare each detection result in the detection set with its corresponding detection result threshold. If two or more detection results are outside the detection result threshold range, it indicates that the detection equipment is malfunctioning. The detection result threshold is a data range with an upper and lower limit.
[0059] Specifically, the POCT device used in this embodiment is a SuperFlex. The method for determining the detection result threshold for each quality control concentration is typically as follows: using a POCT device in a controlled state, at least 20 samples are set for each concentration of the quality control sample. For example, three concentrations are set: a first concentration, a second concentration, and a third concentration. At least 20 samples are used for each of the three concentrations. For the first concentration, the average detection result of all samples at this concentration is calculated. 0.7 times the average value is used as the lower limit of the detection result threshold, and 1.3 times the average value is used as the upper limit of the detection result threshold.
[0060] Similarly, for the second and third concentrations, the lower and upper limits of the corresponding detection result thresholds are calculated using the same method as for the first concentration. This allows us to obtain the upper and lower limits of the detection result thresholds for each concentration of quality control material.
[0061] When the testing equipment is under control, the average values of the upper and lower thresholds of the test results corresponding to each quality control item in the quality control set are normalized, and the normalized average values are plotted in a two-dimensional coordinate system; the test results in the test set are normalized, and the normalized test results are plotted in a two-dimensional coordinate system. The average value of the detection result threshold and the difference between the detection results for each quality control item are obtained. The dispersion of all differences is calculated. If the dispersion is greater than the dispersion threshold, the current detection equipment is out of control. The dispersion can be the variance or standard deviation of a set of differences, and the dispersion threshold is set to 0.1-0.15.
[0062] Preferably, when the detection equipment is under control, and there is one detection result in the detection set that is not within the detection result threshold range; The obtained dispersion is weighted, and the weight coefficients are obtained as follows: Calculate the detection set relative error Specifically, this involves: calculating the average value K of the normalized detection results; and calculating the detection set... The average value of the upper and lower limits of the threshold for each corresponding detection result Where i takes values from 1 to n, and n is the quantity of quality control products, then calculate... The average value B; the relative error is calculated using the following formula. :
[0063] Calculate the difference between the detection results that are outside the detection result threshold range and the average of the upper and lower limits of the corresponding detection result threshold. Then the weighting coefficient for:
[0064] In the above formula, A is calculated as follows: first, obtain the upper and lower limits of the detection result threshold corresponding to the detection result that is not within the detection result threshold range, calculate the average value X of the upper and lower limits of the detection result threshold, and then calculate the average value of the detection result that is not within the detection result threshold range and the average value X. Calculated weighting coefficients Multiply by the original dispersion Then combine with the original dispersion The weighted dispersion is obtained by adding them together. Using the weighted dispersion The detection equipment is compared with the dispersion threshold to determine whether it is out of control; the specific formula is:
[0065] in This represents the weighted dispersion. This represents the original dispersion.
[0066] Obtain the testing timeline of the quality control samples, and determine the timeliness of the testing module based on the testing timeline. Specifically, this includes: The detection time of the quality control product is obtained according to the set cycle, and the detection time of multiple cycles is plotted as a time axis. A first time threshold range and a second time threshold range are set, wherein the first time threshold range is within the second time threshold range. Determine the number of time values within the time axis that exceed the first time threshold range. If two or more consecutive time values exceed the upper limit of the first time threshold range, or two or more consecutive time values are lower than the lower limit of the first time threshold range, the detection device is out of control and recorded as the first out of control; otherwise, continue to make judgments. Determine the number of time values within the time axis that exceed the second time threshold range. If one or more time values exceed the second time threshold range, the detection device is out of control and is recorded as the second out of control. Otherwise, continue the judgment process. The system determines the number of time values within the time axis that exceed the first time threshold range. If there is a time value that exceeds the upper limit of the first time threshold range and there is also a time value that is below the lower limit of the first time threshold range, the detection device is out of control and is recorded as the third out of control. Otherwise, the detection device is under control.
[0067] The first time threshold ranges from -2 minutes to 2 minutes; the second time threshold ranges from -3 minutes to 3 minutes.
[0068] Determine the number of time values within the time axis that exceed a first time threshold range. If a time value exceeds the upper limit of the first time threshold range, or if a time value falls below the lower limit of the first time threshold range, then obtain the test results of the quality control samples within this time period. A time value exceeding the first time threshold is defined as a time anomaly. Each test result is compared with the corresponding test result threshold. If two or more of the test results of the quality control products corresponding to the 10 time values adjacent to the time anomaly are not within the test result threshold range, it indicates that the testing equipment is out of control. Alternatively, if the test result of the quality control product corresponding to the time anomaly is not within the test result threshold range, it is determined that the testing equipment is out of control.
[0069] Step eight also includes: S85. Based on the results of the loss of control, determine the cause of the loss of control, specifically as follows: If it is the first instance of loss of control, then it is a systematic error, and the detection equipment needs to be repaired. If it is the second type of out-of-control, it is due to random error or systematic error. In addition to repairing the equipment, it is also necessary to replace the quality control products and retest. If the third out-of-control item is found, it is due to random error and the quality control material needs to be replaced and retested.
[0070] In addition, the "average value" mentioned in this embodiment refers to the arithmetic mean.
[0071] Example 3 This embodiment provides a method for managing POCT testing projects. The difference between this embodiment and Embodiment 2 lies in step eight, which specifically includes: Step 81: Obtain n quality control samples with different concentration levels and use the detection module to detect the quality control samples; In this embodiment, two quality control samples with different concentration levels are set, one is high concentration and the other is low concentration. Specifically, the high concentration can be set according to the critical value range of the detection item.
[0072] Step 82: Obtain the test results of multiple quality control products according to the set frequency; in this embodiment, the set frequency is to test the quality control products once a day, so the test results of two quality control products are obtained every day.
[0073] Step 83: Obtain the test results of all quality control products within the set time period. In this embodiment, the set time is a natural month. In other embodiments, it can also be set to other times, such as the 20th day.
[0074] Step 84: Based on the test results of all quality control products within the set time, determine whether the testing module is out of control.
[0075] The test results of all quality control samples within a calendar month were divided into two groups based on high and low concentrations. Each group's test results corresponded to a mean, a first range, a second range, and a third range. In this embodiment, the mean of the low concentration group was 0.4, the first range was 0.36-0.44, the second range was 0.32-0.48, and the third range was 0.28-0.52; the mean of the high concentration group was 21.1, the first range was 18.99-23.21, the second range was 16.88-25.32, and the third range was 14.77-27.43.
[0076] For the low concentration group and the high concentration group, quality control charts were plotted respectively. In the quality control chart, the horizontal axis represents time and the vertical axis represents the test results of the quality control sample. In addition, the mean, the upper and lower limits of the first range, the upper and lower limits of the second range, and the upper limit of the third range were plotted in the quality control chart.
[0077] If a test result in a quality control chart, whether in the low-concentration group or the high-concentration group, exceeds the upper or lower limit of the second range, the processing center will issue a warning, indicating that the equipment is close to being out of control, but has not actually gone out of control.
[0078] If a quality control chart shows a result exceeding the upper or lower limit of the third range in either the low-concentration or high-concentration group, the detection module is out of control. For example... Figure 3 The quality control chart shown has two test results that exceed the upper limit of the third range, indicating that the detection module is out of control. Figure 4 The quality control chart shown indicates that there is a test result that exceeds the upper limit of the third range, and there is also a test result that exceeds the lower limit of the third range, indicating that the detection module is out of control.
[0079] If two quality control charts from the same month both show a test result that exceeds the upper limit of the second range in the same direction, or exceeds the lower limit of the second range in the same direction, then the testing module is out of control. For example... Figure 3 and Figure 4 As shown, the quality control chart for the high concentration group has a detection result that exceeds the upper limit of the second range, and the quality control chart for the low concentration group also has a detection result that exceeds the upper limit of the second range, indicating that the detection module is out of control.
[0080] If, in a quality control chart, whether in the low-concentration group or the high-concentration group, two or three test results exceed the upper limit of the second range in the same direction, or two or three test results exceed the lower limit of the second range in the same direction, then the detection module is out of control. For example... Figure 5 As shown, three detection results exceeded the upper limit of the second range, indicating that the detection module malfunctioned. Figure 6 As shown, there are two detection results that both exceed the lower limit of the second range, indicating that the detection module is out of control.
[0081] If, in a quality control chart, whether in the low-concentration group or the high-concentration group, one test result exceeds the upper limit of the second range, and another test result exceeds the lower limit of the second range, then the detection module is out of control.
[0082] If, in two quality control charts for the same month, one chart contains a test result exceeding the upper limit of the second range, and the other chart contains a test result exceeding the lower limit of the second range, then the testing module is out of control.
[0083] If, in a quality control chart, whether in the low concentration group or the high concentration group, four or more test results exceed the upper limit of the second range in the same direction, or four or more test results exceed the lower limit of the second range in the same direction, then the detection module is out of control.
[0084] S85. Based on the out-of-control result, determine whether the detection value in step S7 needs to be corrected, specifically: If it is determined in step S84 that the detection module is out of control, then it is determined whether the detection value in step S7 is within the judgment range. The judgment range is determined based on the lower limit of the second trigger range judged by the alarm information. The judgment range is near the lower limit of the second trigger range judged by the alarm information. For example, if the lower limit of the second trigger range judged by the alarm information is 0.15µg / L, then the judgment range can be set to 0.12µg / L-0.18µg / L.
[0085] If the detection value in step S7 is within the judgment range of 0.12µg / L-0.18µg / L, then the detection value is inaccurate and may trigger an incorrect first alarm message or a second alarm message. It is necessary to determine whether the detection value in step S7 has triggered an incorrect first alarm message or a second alarm message based on the patient's clinical symptoms.
[0086] For example, if a patient's troponin level is 0.12 µg / L, triggering the first alarm message indicates that the patient's troponin level is positive but not critical. However, if it is determined that the detection module is out of control and the patient's clinical symptoms are indicative of a critical condition, then the patient's troponin level is considered a critical value, and the second alarm message will be triggered.
[0087] For example, if a patient's troponin level is 0.18 µg / L, triggering the second alarm message indicates that the patient's troponin level is critical. However, if it is determined that the detection module is out of control and the patient's clinical symptoms do not meet the criteria for a critical condition, then the patient's troponin level is not critical and the first alarm message is triggered.
[0088] The judgment range can be adjusted according to actual needs.
[0089] The above specific embodiments are only used to illustrate the technical solutions of the present invention and are not intended to limit it. Although the present invention has been described in detail with reference to examples, those skilled in the art should understand that modifications or equivalent substitutions can be made to the technical solutions of the present invention without departing from the scope of the technical solutions of the present invention, and all such modifications or substitutions should be covered within the scope of the claims of the present invention.
Claims
1. A POCT testing project management method, used in conjunction with a POCT testing project management system, characterized in that, POCT testing project management methods include: Step 1: Connect the port of the detection module to the processing center; Step 2: Load the hospital information system and laboratory information system onto the processing center; Step 3: The processing center establishes testing items based on patient information; Step 4: Use the detection module to detect the sample to be tested, and the processing center obtains the test results; Step 5: The processing center issues an electronic test report based on the patient information, test items, and test results; Step Six: The processing center will transmit the electronic test report to the hospital information system; The method further includes: Step 8: Perform quality control management on the detection module according to the set frequency, specifically including: S81. Obtain n quality control samples with different concentration levels and use the detection module to detect the quality control samples; S82. Obtain the test results of the quality control products and determine the accuracy of the testing module based on the test results; S83. Obtain the detection timeline of the quality control product and determine the timeliness of the detection module based on the detection timeline; S84. Determine whether the detection module is out of control based on accuracy and timeliness; Obtain the test results of the quality control samples, and determine the accuracy of the testing module based on the test results; specifically including: The quality control samples used at the same time were set to different concentrations, arranged in descending order of concentration, and labeled as a quality control sample set. Each quality control item in the quality control set is tested, and the test results of the quality control set are obtained and marked as the test set. The order of the test results in the test set corresponds to that in the quality control set; Obtain the detection result threshold corresponding to each concentration of quality control material, compare each detection result in the detection set with the corresponding detection result threshold, and if more than two detection results are not within the detection result threshold range, it indicates that the detection equipment is out of control; When the testing equipment is under control, the average value of the test result threshold corresponding to each quality control item in the quality control set is normalized, and the normalized average value is plotted in a two-dimensional coordinate system; the test result in the test set is normalized, and the normalized test result is plotted in a two-dimensional coordinate system. Obtain the average value of the detection result threshold and the difference between the detection results for each quality control item. Calculate the dispersion of all differences. If the dispersion is greater than the dispersion threshold, the current detection equipment is out of control. When the detection equipment is under control, and there is one detection result in the detection set that is not within the detection result threshold range; The obtained dispersion is weighted, and the weight coefficients are obtained as follows: Calculate the detection set relative error Specifically, this involves: calculating the average value K of the normalized detection results; and calculating the detection set... The average value of the upper and lower limits of the threshold for each corresponding detection result Where i takes values from 1 to n, then calculate The average value B; the relative error is calculated using the following formula. : Calculate the difference between the detection results that are outside the detection result threshold range and the average of the upper and lower limits of the corresponding detection result threshold. Then the weighting coefficient for: In the above formula, A is calculated as follows: first, obtain the upper and lower limits of the detection result threshold corresponding to the detection result that is not within the detection result threshold range, calculate the average value X of the upper and lower limits of the detection result threshold, and then calculate the average value of the detection result that is not within the detection result threshold range and the average value X. Calculated weighting coefficients Multiply by the original dispersion Then combine with the original dispersion The weighted dispersion is obtained by adding them together. Using the weighted dispersion The detection equipment is compared with the dispersion threshold to determine whether it is out of control; the specific formula is: in This represents the weighted dispersion. This represents the original dispersion. The POCT testing project management system includes: The acquisition module is used to acquire the sample to be tested; The detection module is used to detect samples and send the detection results to the processing center; The processing center is used to receive test results and issue test reports based on the test results; The processing center can interact with the hospital information system and the laboratory information system. The processing center includes an alarm module and a quality control management module; The alarm module is used to provide alarm prompts based on a set threshold. The quality control management module is used to perform quality control management on the testing module; The quality control management module includes an accuracy detection unit and a timeliness detection unit. The accuracy detection unit, based on n quality control samples at different concentration levels, obtains the accuracy of the detection module in detecting the quality control samples, specifically including: The quality control samples used at the same time were set to different concentrations, arranged in descending order of concentration, and labeled as a quality control sample set. Each quality control item in the quality control set is tested, and the test results of the quality control set are obtained and marked as the test set. The order of the test results in the test set corresponds to that in the quality control set; Obtain the detection result threshold corresponding to each concentration of quality control material, compare each detection result in the detection set with the corresponding detection result threshold, and if more than two detection results are not within the detection result threshold range, it indicates that the detection equipment is out of control.
2. The POCT testing project management method according to claim 1, characterized in that, Also includes: Step 7: The processing center obtains the detection values from the detection results and judges each detection value. If a detection value is not within the first trigger range of the corresponding detection item, and is not within the second trigger range of the corresponding detection item, then the first alarm information is triggered. If a certain detection value falls within the second trigger range corresponding to that detection item, then the second alarm message is triggered; If all test values are normal, the timeline of the test items is obtained, and the time T from the start of the test to the completion of the electronic test report is calculated. If the time T is greater than the set time threshold, the third alarm information is triggered.
3. The POCT testing project management method according to claim 2, characterized in that, If a second alarm is triggered, the processing center will send the alarm information to the medical staff's mobile device. The second alarm will be deactivated after the medical staff turns off the alarm notification on their mobile device.
4. The POCT testing project management method according to claim 1, characterized in that, Obtain the testing timeline of the quality control samples, and determine the timeliness of the testing module based on the testing timeline. Specifically, this includes: The detection time of the quality control product is obtained according to the set cycle, and the detection time of multiple cycles is plotted as a time axis. A first time threshold range and a second time threshold range are set, wherein the first time threshold range is within the second time threshold range. Determine the number of time values within the time axis that exceed the first time threshold range. If two or more consecutive time values exceed the upper limit of the first time threshold range, or two or more consecutive time values are lower than the lower limit of the first time threshold range, the detection device is out of control and recorded as the first out of control; otherwise, continue to make judgments. Determine the number of time values within the time axis that exceed the second time threshold range. If one or more time values exceed the second time threshold range, the detection device is out of control and is recorded as the second out of control. Otherwise, continue the judgment process. The system determines the number of time values within the time axis that exceed the first time threshold range. If there is a time value that exceeds the upper limit of the first time threshold range and there is also a time value that is below the lower limit of the first time threshold range, the detection device is out of control and is recorded as the third out of control. Otherwise, the detection device is under control.
5. The POCT testing project management method according to claim 4, characterized in that, Determine the number of time values within the time axis that exceed a first time threshold range. If a time value exceeds the upper limit of the first time threshold range, or if a time value falls below the lower limit of the first time threshold range, then obtain the test results of the quality control samples within this time period. The time value exceeding the first time threshold is set as the time anomaly value. Each test result is compared with the corresponding test result threshold. If more than two of the test results of the quality control products corresponding to the 10 time values adjacent to the time anomaly value are not within the test result threshold range, it indicates that the test equipment is out of control. Alternatively, if the test result of the quality control product corresponding to the time anomaly is not within the test result threshold range, then the test equipment is judged to be out of control.
6. The POCT testing project management method according to claim 4, characterized in that, Step eight also includes: S85. Based on the results of the loss of control, determine the cause of the loss of control, specifically as follows: If it is the first instance of loss of control, then it is a systematic error, and the detection equipment needs to be repaired. If it is the second type of out-of-control, it is due to random error or systematic error. In addition to repairing the equipment, it is also necessary to replace the quality control products and retest. If the third out-of-control item is found, it is due to random error and the quality control material needs to be replaced and retested.
7. The POCT testing project management method according to claim 1, characterized in that, The method further includes: Step 8: Perform quality control management on the detection module according to the set frequency, specifically including: Step 81: Obtain n quality control samples with different concentration levels and use the detection module to detect the quality control samples; Step 82: Obtain the test results of multiple quality control samples according to the set frequency; Step 83: Based on the set time, obtain the test results of all quality control products within the set time period; Step 84: Based on the test results of all quality control products within the set time, determine whether the testing module is out of control.
8. The POCT testing project management method according to claim 7, characterized in that, Step eight also includes: S85. Based on the out-of-control result, determine whether the detection value in step S7 needs to be corrected.
9. The POCT testing project management method according to claim 1, characterized in that, The alarm module includes a first alarm module and a second alarm module. The first alarm module acquires the detection result. If the detection result is not within the first trigger range and not within the second trigger range, the first alarm information is triggered. The second alarm module acquires the detection result. If the detection result is within the second trigger range, it triggers the second alarm message.