TWI783873B - Validation method and system for medical examination data - Google Patents

Abstract

A validation system for medical examination data includes an inspection instrument for inspecting a plurality of persons to generate a plurality of examination data separately. A data analysis instrument for setting a first critical range not less than a lower limit of a normal range minus an error value. Notify the persons whose data of the subsequent test fall within the first critical range to retest so as to produce a retest report respectively if more than a percentage of the persons fall within the first critical range and the first misjudgment range in the subsequent and subsequent tests. The difference between the first misjudgment range and the lower limit value is one misjudgment value. If each retest report and the corresponding subsequent test data all fall in the same first misjudgment range, the error value is set as the misjudgment value.

Description

Medical examination data verification method and system

The present invention mainly relates to a medical examination data verification method and system, in particular to a medical examination data verification method and system for adjusting the accuracy of medical examination equipment.

In medical institutions, medical-related electronic equipment is commonly used to assist medical personnel in monitoring the physiological data of patients, and assessing the physical health of the patient by judging whether the physiological data is abnormal or not. For different test items, a normal range is usually given, and according to whether the physiological data falls within the normal range, the test result of the patient relative to the test item is determined to be normal or abnormal. In addition, in practice, an error value will be further given on the basis of the normal range, that is, even if the patient's physiological data exceeds the normal range, if the physiological data does not exceed the normal range plus or minus the error value However, the patient can still be considered normal.

The accuracy of inspection and analysis of the same type of medical electronic equipment may vary slightly, and the result may be caused by problems in the manufacturing process. However, the precision gap between these medical electronic devices may easily cause the physiological data that originally fell closer to the upper limit or lower limit of the normal range to eventually exceed the normal range plus or minus the error value. Or, falling within the range of the normal range plus or minus the error value, the final test result may change from normal test to abnormal test, or from abnormal test to normal test, which has the problem of low reliability of the test result, and then Reduce overall medical quality and patient safety.

In view of this, it is necessary to provide a medical examination data verification method and system to solve the above problems.

The purpose of the present invention is to provide a medical examination data verification method and system, which can be used to adjust the accuracy of medical examination equipment.

The "specimen" mentioned throughout the present invention refers to cells, tissues, organs, body fluids or their derived substances (including genetic material) separated from the human body.

In order to achieve the above object, the present invention provides a method for verifying medical examination data, which includes: specifying a test item, and using a testing instrument to measure several examinees according to the test item in several different periods, so as to generate each test item. An inspection report of the inspected person, the inspection report has an identification code and an inspection data for each period; setting a first critical range and a second critical range of the inspection item, the first critical range is smaller than the inspection item The lower limit of a normal range, and not less than the lower limit minus an error value; the second critical range is greater than the upper limit of the normal range, and not greater than the upper limit plus the error value; check Each of the inspected personnel’s two consecutive inspection reports before and after, if more than a percentage of the inspected personnel’s inspection data in the previous inspection falls within the first critical range within a continuous time period, and the inspection data in the subsequent inspection falls within the first critical range A first misjudgment range, the first misjudgment range is smaller than the first critical range and differs from the lower limit value by a misjudgment value, or, the previous inspection data falls within the second critical range, and the next If the inspection data falls within a second misjudgment range, and the second misjudgment range is greater than the first critical range and differs from the upper limit by the misjudgment value, then during the continuous time period, the next inspection data falls within the first critical range. A critical area and several inspected persons in the second critical area are marked, so as to generate a circled list according to the identification codes of the several inspected persons; notify the several inspected persons in the circled list to use the The detection instrument re-inspects to generate a retest test report; and compares whether each retest test report and the corresponding last test data fall within the same first misjudgment range or the second misjudgment range , if the comparison result is yes, the error value is set as the misjudgment value, so as to expand the lower limit of the first critical range of the detection instrument to the lower limit of the first false positive range, and the second The upper limit of the critical range is extended to the upper limit of the second misjudgment range.

The present invention also provides a medical examination data verification system, including: a detection instrument, used to designate a test item, and measure several examinees according to the test item in several different periods, so as to generate each test item. An inspection report for personnel, the inspection report has an identification code and an inspection data for each period; and a data analysis instrument, electrically connected to the inspection instrument, and has a processing unit, which is used to set the inspection item A first critical range and a second critical range, the first critical range is less than the lower limit of a normal range of the inspection item, and not less than the lower limit minus an error value, the second critical range is greater than The upper limit of the normal range, and not greater than the upper limit plus the error value, the processing unit checks the two consecutive inspection reports of each inspected person. The inspector's inspection data in the previous time falls within the first critical range, and the subsequent inspection data falls within a first misjudgment range, and the first misjudgment range is smaller than the first critical range and differs from the lower limit by one misjudgment value, the processing unit marks several inspected persons whose inspection data falls within the first critical range and the second critical range in the continuous time, so that according to the number of inspected persons The identification code generates a circled list, and the processing unit notifies several inspected personnel in the circled list to re-test with the testing instrument, so as to generate a retest test report respectively, and the processing unit compares the test results of each retest Whether the report and the corresponding subsequent inspection data fall within the same first misjudgment range or the second misjudgment range, if the comparison result is yes, the processing unit sets the error value as the misjudgment value.

In some embodiments, the testing equipment is used to test the samples of the several inspected persons in the several different periods respectively, so as to generate the inspection report of each of the inspected persons, and the inspection report has the identification code and the Inform the several inspected persons in the circled list to re-examine the respective inspection data of several specimens with the testing instrument, or use the testing instrument to re-examine the several inspected persons in the next test. samples to generate the test-retest report respectively.

In some embodiments, during the continuous time and at least one day before and after each, several inspected persons whose inspection data in the latter time fall within the first critical range and the second critical range are marked to generate the circle pick list. In this way, the number of samples of inspected persons can be increased, and the accuracy can be improved.

In some embodiments, the processing unit checks the two consecutive inspection reports of each inspected person, if the inspection data of the inspected persons exceeding the percentage within the continuous time falls within the second threshold range, and when the last inspection data falls within a second misjudgment range, the second misjudgment range is greater than the second critical range and differs from the upper limit value by the misjudgment value, and the processing unit also within the continuous time, Mark the several inspected persons whose data of the last inspection falls within the first critical range and the second critical range, so as to generate the circled list according to the identification codes of the several inspected persons.

In some embodiments, the data analysis instrument has a database unit electrically connected to the processing unit, and the database unit is used for storing the plurality of test reports and corresponding test results.

In some embodiments, the data analysis instrument has an output unit electrically connected to the processing unit, and the processing unit controls the output unit to display the inspection results of the inspected persons recorded in the database unit.

The medical examination data verification method and system of the present invention have the following characteristics: the error value and the misjudgment value can be set relative to the normal range of the inspection item to delineate the first critical range, the second critical range, the The first misjudgment range and the second misjudgment range, and by checking the inspection data of the inspected personnel twice before and after, whether they fall in the first adjacent range/the second critical range, and whether they fall in the first range of misjudgment/the second range of misjudgment, to notify the inspected personnel whose test data falls within the first critical range and the second critical range to re-test to generate the re-test test report respectively; When the test report and the corresponding subsequent test data fall within the same first misjudgment range/second misjudgment range, the error value is set as the misjudgment value. In this way, the error value relative to the normal range can be adjusted according to the accuracy of the detection instrument itself, which has the effect of improving the reliability of the test result.

The embodiments of the present invention are described in detail below in conjunction with the drawings. The attached drawings are mainly simplified schematic diagrams, which only schematically illustrate the basic structure of the present invention. Therefore, only components related to the present invention are marked in these drawings. , and the displayed components are not drawn according to the number, shape, size ratio, etc. of the actual implementation. The actual size of the actual implementation is a selective design, and the layout of the components may be more complicated.

The following descriptions of the various embodiments refer to the accompanying drawings to illustrate specific embodiments in which the present invention may be practiced. In the description of the present invention, the word "comprising" will be understood as meaning including the stated elements, but not excluding any other elements, unless explicitly described to the contrary.

Please refer to Fig. 1, which is a preferred embodiment of the medical examination data verification method of the present invention, which includes: a test step S1, an analysis step S2, a circle selection step S3, a retest step S4 and an adjustment step S5.

The inspection step S1 is used to designate an inspection item, and use a testing instrument to measure several inspected persons according to the inspection item in several different periods, so as to generate an inspection report for each inspected person, the inspection report It has an identification code and an inspection data of each period, wherein the several different periods can be different years, and the identification code can be a serial number, but not limited thereto.

In another embodiment, the inspection step S1 is used to designate another inspection item, and use another detection instrument to perform inspections on the samples of the several inspected persons in several different periods according to the another inspection item, to generate an inspection report for each of the inspected persons, and the inspection report has the identification code and an inspection data of each of the plurality of specimens.

The analysis step S2 is used to set a first critical range and a second critical range of the inspection item, the first critical range is less than the lower limit of a normal range of the inspection item, and is not less than the lower limit minus An error value; the second critical range is greater than the upper limit of the normal range and not greater than the upper limit plus the error value. Among them, the error value will be different according to the test item. Taking the test item as the number of white blood cells in the blood as an example, the normal range of the white blood cells is 4500-10000 (cu.mm). The error value can be set is 10, at this time, the first critical range falls between 4490-4500, and the second critical range falls between 10000-10010. When the inspection data of the inspected person falls within the first critical range or the second critical range, the inspected person is still considered as having a normal white blood cell count. It should be noted that, in this implementation, the first critical range includes 4490 but does not include 4500, and the second critical range includes 10010 but does not include 10000.

Check the two consecutive inspection reports of each inspected person. If more than a percentage of the inspected persons fall within the first critical range in the previous inspection data within a continuous period, and fall within the next inspection data In a first misjudgment range, the first misjudgment range is smaller than the first critical range and differs from the lower limit by a misjudgment value, or, the previous inspection data falls within the second critical range, and the next If the test data falls within a second misjudgment range, and the second misjudgment range is greater than the first critical range and differs from the upper limit value by the misjudgment value, then the subsequent circle selection step S3 and retest step S4 are executed to start the retest Mechanism to confirm whether it is caused by the abnormal accuracy of the detection instrument, and the inspected personnel whose inspection data falls between the first critical range and the second critical range can be deemed as normal, and the If the inspection data falls within the first misjudgment range or the second misjudgment range, it is determined that the inspection is abnormal; otherwise, it is not necessary to perform additional actions and continue to inspect other inspected persons.

For example, the continuous time can be set to 3 days, and the percentage can be set to 30%, but not limited thereto. On the other hand, the misjudgment value will also vary according to the test item. Taking the test item as the number of white blood cells contained in the blood as an example, the misjudgment value can be 1 to 3 times the error value. In this embodiment , the false positive value can be set to 30, at this time, the first false positive range falls between 4470-4490, and the second false positive range falls between 10010-10030. It should be noted that in this implementation, the first misjudgment range includes 4470 but does not include 4490, and the second misjudgment range includes 10030 but does not include 10010.

The circle selection step S3 is used for when the inspection data of one of the inspected persons falls within the first misjudgment range or the second misjudgment range, during the continuous time, the next inspection data falls within the first misjudgment range. Mark the critical range and the several inspected persons in the second critical range, so as to generate a circle selection list according to the identification codes of the several inspected persons. Preferably, the circle selection step S3 can increase the number of days of circle selection, so as to circle more persons to be inspected. In this embodiment, the continuous time and at least one day before and after it (for example: 5 days, i.e. A total of 13 days), the number of inspected persons whose data of the last inspection falls within the first critical range and the second critical range are marked to generate the circled list.

The re-testing step S4 is used to notify several inspected persons in the circled list to re-test with the testing instrument, so as to generate a re-testing test report respectively. On the other hand, when the detection instrument is used to detect the samples of the inspected person in several different periods, the re-testing step S4 is used to notify the several inspected persons in the circled list to use the detection re-examination with the instrument, that is, to collect a new specimen of each subject under examination relative to the other examination item, so as to examine the new specimen of each subject under examination; Each of the inspected personnel's samples in the next time, that is, re-examines the samples collected and stored by each of the inspected persons before, so as to generate the re-examination inspection report respectively. In this embodiment, the notification can be made through social software, SMS or telephone, but not limited thereto.

The adjustment step S5 is used to compare whether each of the retest inspection reports and the corresponding subsequent inspection data fall within the same first misjudgment range or the second misjudgment range, if the comparison result is yes, it means That is, the detection accuracy of the testing instrument exceeds the allowable range of the error value set by the testing item, so the error value is set as the false positive value to expand the lower limit of the first critical range of the testing instrument to the lower limit of the first misjudgment range, and expand the upper limit of the second critical range to the upper limit of the second misjudgment range, and place the latter inspection data within the adjusted first The inspected persons within the misjudgment range or the second misjudgment range are re-determined as normal; if the comparison result is negative, no additional action is required.

Please refer to FIG. 2 , which is a preferred embodiment of the medical examination data verification system of the present invention, which includes: a detection device 1 and a data analysis device 2 , the detection device 1 is electrically connected to the data analysis device 2 .

The testing instrument 1 is used to designate an inspection item, and measure several inspected personnel according to the inspection item in several different periods, so as to generate an inspection report for each inspected person, and the inspection report has an identification code and a test data for each period. Wherein, the several different periods may be different years, and the identification code may be a Liushui number, but not limited thereto.

The inspection item takes heart examination as an example. The detection instrument 1 can be an electrocardiogram detector, and the inspection data can be converted into a QRS complex wave by converting the ECG signal measured by the detection instrument 1 into a QRS complex. The output value after noise filtering.

In another embodiment, the detection instrument 1 can detect the specimens of the several inspected persons in several different periods respectively, so as to generate the inspection report of each inspected person, and the inspection report has the identification code and The test data of each of the several specimens. Wherein, the several specimens can be stored in a test tube respectively.

For example, the test item can check the number of various blood cells in the blood, then the detection instrument 1 can be an automatic blood cell analyzer, and the test data can be the number of white blood cells. In addition, in other embodiments, according to different test items, the detection instrument 1 can also be a fully automatic biochemical analyzer, a fully automatic blood coagulation analyzer, an automatic biochemical immune analyzer, a fully automatic urine analyzer, an osmotic pressure analyzer Or a fully automatic fecal occult blood analyzer, and obtain the corresponding test data respectively, which can be understood by those with ordinary knowledge in the relevant fields of the present invention.

The data analysis instrument 2 is electrically connected to the detection instrument 1, and has a database unit 21 and a processing unit 22, wherein the database unit 21 is used to store the test reports, and the processing unit 22 is electrically connected to the The database unit 21 is used to set a first critical range and a second critical range of the inspection item, the first critical range is less than the lower limit of a normal range of the inspection item, and is not less than the lower limit minus minus an error value, the second critical range is greater than the upper limit of the normal range and not greater than the upper limit plus the error value. For example, the data analysis instrument 2 can be a host computer, but not limited thereto.

The processing unit 22 checks the two consecutive inspection reports of each inspected person, if more than a percentage of the inspected persons in the previous inspection data fall within the first critical range within a continuous time period, and in the next inspection report The inspection data falls within a first misjudgment range, the first misjudgment range is smaller than the first critical range and differs from the lower limit value by a misjudgment value, and the processing unit 22, during the continuous time, in the next inspection data The several inspected persons falling within the first critical range and the second critical range are marked, so as to generate a circled list according to the identification codes of the several inspected persons.

On the other hand, the processing unit 22 checks the two consecutive inspection reports of each inspected person, if the inspection data of the inspected persons exceeding the percentage within the continuous time falls within the second critical range , and when the last test data falls within a second misjudgment range, the second misjudgment range is greater than the second critical range and differs from the upper limit value by the misjudgment value, the processing unit 22 can also , mark the several inspected persons whose last inspection data falls within the first critical range and the second critical range, so as to generate the circled list according to the identification codes of the several inspected persons.

In addition, the processing unit 22 may determine that the test subject whose test data falls between the first critical range and the second critical range is normal, and the test data falls within the first misjudgment range or the second critical range. 2. The inspected persons in the misjudgment range are identified as inspection abnormalities, and the inspection results of each inspected person and the corresponding inspection report are stored and recorded in the database unit 21 .

Preferably, the processing unit 22 can increase the number of days to be circled, so as to circle more persons to be inspected. In this embodiment, the continuous time and at least one day before and after it can be included in the last inspection data A number of inspected persons falling within the first critical range and the second critical range are marked to generate the circled list.

In this embodiment, the processing unit 22 may set the continuous time as 3 days and the percentage as 30%, but not limited thereto. On the other hand, the error value and the misjudgment value will vary according to the type of the test item. Taking the test item as the number of white blood cells in the blood as an example, the error value can be 10, and the misjudgment value can be 30.

The database unit 21 also stores the respective contact information of the several inspected persons, and the processing unit 22 notifies the several inspected persons in the circled list to re-examine with the testing instrument 1 through the contact information, and to use the testing device 1 to perform the inspection respectively. Generate a test-retest inspection report. In detail, when the detection instrument 1 is used to detect the samples of the examinee in several different periods, the processing unit 22 notifies the several examinees in the circled list to use the detection apparatus 1 Re-testing, that is, collecting a new sample of each of the inspected persons relative to the other inspection item, so as to inspect the new samples of each of the inspected persons; or re-examining the data with the testing instrument 1 Each of the inspected personnel's samples in the next time, that is, re-examines the samples collected and stored by each of the inspected persons before, so as to generate the re-examination inspection report respectively.

The processing unit 22 compares each of the retest inspection reports with the corresponding subsequent inspection data, whether they all fall within the same first misjudgment range or the second misjudgment range, and if the comparison result is yes, the processing unit 22. Set the error value as the misjudgment value, so as to expand the lower limit of the first critical range of the detection instrument 1 to the lower limit of the first misjudgment range, and the upper limit of the second critical range Expand to the upper limit of the second misjudgment range, and re-identify the inspected personnel whose inspection data falls within the adjusted first misjudgment range or the second misjudgment range as normal, and adjust accordingly The record stored in the database unit 21; if the comparison result is negative, the processing unit 22 does not need to perform additional actions.

The data analysis instrument 2 of the medical examination data verification system of the present invention can also have an output unit 23 electrically connected to the processing unit 22, and the processing unit 22 controls the output unit 23 to display and record each subject in the database unit 21. The inspector's inspection results. For example, the output unit 23 can be a display screen.

Based on the above, the medical examination data verification method and system of the present invention can set the error value and the misjudgment value relative to the normal range of the test item, so as to delineate the first critical range and the second critical range , the first misjudgment range and the second misjudgment range, and by checking the inspection data of the inspected personnel twice before and after, whether they fall in the first adjacent range/the second critical range, and fall in the The first misjudgment range/the second misjudgment range, to notify the inspected personnel whose test data falls within the first critical range and the second critical range to re-inspect, so as to generate the retest test report respectively; if each When the test-retest report and the corresponding test data of the last time both fall within the same first misjudgment range/the second misjudgment range, the error value is set as the misjudgment value. In this way, the error value relative to the normal range can be adjusted according to the accuracy of the detection instrument itself, which has the effect of improving the reliability of the test result.

The embodiments disclosed above are only illustrative of the principles, features and effects of the present invention, and are not intended to limit the scope of the present invention. Any person familiar with the art can, without departing from the spirit and scope of the present invention, Modifications and changes are made to the above-mentioned embodiments. Any equivalent change and modification accomplished by utilizing the content disclosed in the present invention shall still be covered by the scope of the following patent application.

﹝this invention﹞ 1: Testing instrument 2: Data analysis instrument 21: Database unit 22: Processing unit 23: Output unit S1: Inspection steps S2: Analysis step S3: Circle selection steps S4: Retest step S5: Adjustment steps

[Fig. 1] is a method flow chart of the medical examination data verification method of the present invention; [ Fig. 2 ] is a system block diagram of the medical examination data verification system of the present invention.

1: Testing instrument

2: Data analysis instrument

21: Database unit

22: Processing unit

23: Output unit

Claims (7)

A method for verifying medical examination data, comprising: Designate an inspection item, and use a testing instrument to measure several inspected personnel according to the inspection item in several different periods to generate an inspection report for each inspected person. The inspection report has an identification code and each an inspection data for the period; Setting a first critical range and a second critical range of the inspection item, the first critical range is smaller than the lower limit of a normal range of the inspection item, and is not less than the lower limit minus an error value; the first critical range 2. The critical range is greater than the upper limit of the normal range and not greater than the upper limit plus the error value; Check the two consecutive inspection reports of each inspected person. If more than a percentage of the inspected persons fall within the first critical range in the previous inspection data within a continuous period, and fall within the next inspection data In a first misjudgment range, the first misjudgment range is smaller than the first critical range and differs from the lower limit by a misjudgment value, or, the previous inspection data falls within the second critical range, and the next If the test data falls within a second misjudgment range, and the second misjudgment range is greater than the first critical range and differs from the upper limit value by the misjudgment value, then during the continuous time, the next test data falls within the Marking the first critical area and the several inspected persons in the second critical area, so as to generate a circled list according to the identification codes of the several inspected persons; Notify several inspected personnel in the circled list to re-examine with the testing device, so as to generate a re-examination inspection report; and Comparing each of the retest inspection reports and the corresponding last inspection data whether they all fall within the same first misjudgment range or the second misjudgment range, if the comparison result is yes, the error value is set to the misjudgment value to expand the lower limit of the first critical range of the detection instrument to the lower limit of the first false positive range, and to expand the upper limit of the second critical range to above the second false positive range limit. The method for verifying medical examination data as described in Claim 1, wherein the test equipment is used to test the specimens of the several examinees in the several different periods, so as to generate the examination report of each examinee, The inspection report has the identification code and the inspection data of the several specimens, and the inspected persons in the circled list are notified to re-examine with the testing instrument or to re-examine the data with the testing instrument. Each of the tested personnel generates the retest test report for the next sample. The medical examination data verification method as described in Claim 1, wherein, during the continuous time and at least one day before and after each, several subjects whose test data in the latter time fall within the first critical range and the second critical range The inspectors will mark to generate the circled list. A medical examination data verification system, comprising: A testing instrument, used to designate a test item, and measure several inspected persons according to the inspected item in several different periods, so as to generate an inspection report for each inspected person, and the inspection report has an identification code and a survey data for each such period; and A data analysis instrument, electrically connected to the detection instrument, and having a processing unit, the processing unit is used to set a first critical range and a second critical range of the inspection item, the first critical range is smaller than the inspection item A lower limit value of the normal range, and not less than the lower limit value minus an error value, the second critical range is greater than the upper limit value of the normal range, and not greater than the upper limit value plus the error value, the processing The unit checks the two consecutive inspection reports of the inspected personnel. If more than a percentage of the inspected personnel in the previous inspection data fall within the first critical range within a continuous time period, and the inspection data in the subsequent inspection falls within a first false positive range, the first false positive range is smaller than the first critical range and differs from the lower limit value by a false positive value, the processing unit falls within the second detection data within the continuous time period A critical range and several inspected personnel in the second critical range are marked to generate a circle list according to the identification codes of the several inspected persons, and the processing unit notifies the several inspected persons in the circled list re-testing with the testing instrument to generate a retest test report respectively, and the processing unit compares each retest test report with the corresponding last test data to see if they all fall within the same first misjudgment range or For the second misjudgment range, if the comparison result is yes, the processing unit sets the error value as the misjudgment value. The medical examination data verification system as described in Claim 4, wherein, the processing unit checks the inspection reports of each inspected person for two consecutive times before and after, if there are more than the percentage of inspected persons in the previous time in the continuous time The test data of the next test falls within the second critical range, and the next test data falls within a second false positive range, the second false positive range is greater than the second critical range and differs from the upper limit by the false negative value, the The processing unit also marks several inspected personnel whose last inspection data falls within the first critical range and the second critical range during the continuous time, so as to generate The circled list. The medical examination data verification system as described in Claim 4, wherein the data analysis instrument has a database unit electrically connected to the processing unit, and the database unit is used for storing the plurality of test reports and corresponding test results. The medical examination data verification system as described in Claim 6, wherein, the data analysis instrument has an output unit electrically connected to the processing unit, and the processing unit controls the output unit to display each person under examination recorded in the database unit test results.

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