TWI783873B - Validation method and system for medical examination data - Google Patents
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本發明主要為一種醫檢數據驗證方法及系統，特別是有關於一種用以調校醫檢設備精準度的醫檢數據驗證方法及系統。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.
在醫療院所中，普遍使用醫療相關電子設備輔助醫療人員監測病患之生理數據，並透過判斷該生理數據異常與否，以評估該病患的身體健康情況。其中，針對不同的檢驗項目，通常會給定一正常範圍，並且根據該生理數據是否落在該正常範圍內，以決定該病患相對於該檢驗項目的檢驗結果為檢驗正常或檢驗異常。此外，在實務上會在該正常範圍的基準下進一步給定一誤差值，意即，縱使該病患的生理數據超出該正常範圍，若該生理數據未超出該正常範圍加減該誤差值的範圍內，仍可以將該病患認定為檢驗正常。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.
同一種醫療電子設備之間，其在檢驗分析上的精準度可能互有些許差距，而造成的結果可能來自製造過程中所產生的問題。然而，該些醫療電子設備之間的精準度差距，容易造成原先落在較接近該正常範圍之上限值或下限值的生理數據，最終反而超出該正常範圍加減該誤差值的範圍內，或是，落入該正常範圍加減該誤差值的範圍內，使最終的檢驗結果可能由檢驗正常轉變為檢驗異常，或是由檢驗異常轉變為檢驗正常，具有檢驗結果可靠性低的問題，進而降低整體醫療品質與病患安全。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.
有鑑於此，有必要提供一種醫檢數據驗證方法及系統，以解決上述之問題。In view of this, it is necessary to provide a medical examination data verification method and system to solve the above problems.
本發明的目的在於提供一種醫檢數據驗證方法及系統，係可以用以調校醫檢設備精準度。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.
本發明全文所記載之「檢體」，係指與人體分離之細胞、組織、器官、體液或其衍生物質（含遺傳物質）。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.
為達成上述目的，本發明提供一種醫檢數據驗證方法，包含：指定一檢驗項目，並透過一檢測儀器在數個不同時期對數名受檢人員分別根據該檢驗項目進行量測，以產生各該受檢人員的一檢驗報告，該檢驗報告具有一識別代號及各該時期的一檢驗數據；設定該檢驗項目的一第一臨界範圍及一第二臨界範圍，該第一臨界範圍小於該檢驗項目的一正常範圍之下限值，且不小於該下限值減去一誤差值；該第二臨界範圍大於該正常範圍之上限值，且不大於該上限值加上該誤差值；檢查各該受檢人員於前後連續二次的檢驗報告，若一連續時間內具有超過一百分比的受檢人員於前一次的檢驗數據落在該第一臨界範圍，且於後一次的檢驗數據落在一第一誤判範圍，該第一誤判範圍小於該第一臨界範圍且與該下限值相差一誤判值，或是，於前一次的檢驗數據落在該第二臨界範圍，且於後一次的檢驗數據落在一第二誤判範圍，該第二誤判範圍大於該第一臨界範圍且與該上限值相差該誤判值，則將該連續時間中，於該後一次的檢驗數據落在該第一臨界範圍與該第二臨界範圍的數名受檢人員進行標註，以根據該數名受檢人員的識別代號產生一圈選名單；通知該圈選名單中的數名受檢人員分別以該檢測儀器重新進行檢驗，以各自產生一重測檢驗報告；及比對各該重測檢驗報告與相對應的該後一次的檢驗數據是否皆落在相同的該第一誤判範圍或該第二誤判範圍，若比對結果為是，將該誤差值設定成該誤判值，以將該檢測儀器的該第一臨界範圍之下限值擴大至該第一誤判範圍之下限值，以及將該第二臨界範圍之上限值擴大至該第二誤判範圍之上限值。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.
本發明另提供一種醫檢數據驗證系統，包含：一檢測儀器，用以指定一檢驗項目，並在數個不同時期分別對數名受檢人員根據該檢驗項目進行量測，以產生各該受檢人員的一檢驗報告，該檢驗報告具有一識別代號及各該時期的一檢驗數據；及一數據分析儀器，電性連接該檢測儀器，並具有一處理單元，該處理單元用以設定該檢驗項目的一第一臨界範圍及一第二臨界範圍，該第一臨界範圍小於該檢驗項目的一正常範圍之下限值，且不小於該下限值減去一誤差值，該第二臨界範圍大於該正常範圍之上限值，且不大於該上限值加上該誤差值，該處理單元檢查各該受檢人員於前後連續二次的檢驗報告，若一連續時間內具有超過一百分比的受檢人員於前一次的檢驗數據落在該第一臨界範圍，且於後一次的檢驗數據落在一第一誤判範圍，該第一誤判範圍小於該第一臨界範圍且與該下限值相差一誤判值，該處理單元將該連續時間中，於該後一次的檢驗數據落在該第一臨界範圍與該第二臨界範圍的數名受檢人員進行標註，以根據該數名受檢人員的識別代號產生一圈選名單，該處理單元通知該圈選名單中的數名受檢人員分別以該檢測儀器重新進行檢驗，以各自產生一重測檢驗報告，該處理單元比對各該重測檢驗報告與相對應的該後一次的檢驗數據是否皆落在相同的該第一誤判範圍或該第二誤判範圍，若比對結果為是，該處理單元將該誤差值設定成該誤判值。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.
在一些實施例中，透過該檢測儀器對該數名受檢人員在該數個不同時期的檢體分別進行檢測，以產生各該受檢人員的檢驗報告，該檢驗報告具有該識別代號及該數個檢體各自的檢驗數據，通知該圈選名單中的該數名受檢人員分別以該檢測儀器重新進行檢驗，或是以該檢測儀器重新檢驗該數名受檢人員各自於後一次的檢體，以各自產生該重測檢驗報告。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.
在一些實施例中，將該連續時間以及前後各至少一天中，於該後一次的檢驗數據落在該第一臨界範圍與該第二臨界範圍的數名受檢人員進行標註，以產生該圈選名單。如此，係可以增加受檢人員的樣本數，具有提高精確度之功效。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.
在一些實施例中，該處理單元檢查各該受檢人員於前後連續二次的檢驗報告，若該連續時間內具有超過該百分比的受檢人員於該前一次的檢驗數據落在該第二臨界範圍，且於該後一次的檢驗數據落在一第二誤判範圍，該第二誤判範圍大於該第二臨界範圍且與該上限值相差該誤判值，該處理單元亦將該連續時間中，於該後一次的檢驗數據落在該第一臨界範圍與該第二臨界範圍的數名受檢人員進行標註，以根據該數名受檢人員的識別代號產生該圈選名單。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.
在一些實施例中，該數據分析儀器具有一資料庫單元電性連接該處理單元，該資料庫單元用以儲存該數個檢驗報告以及相對應的檢驗結果。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.
在一些實施例中，該數據分析儀器具有一輸出單元電性連接該處理單元，該處理單元控制該輸出單元顯示記錄於該資料庫單元中各該受檢人員的檢驗結果。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.
本發明的醫檢數據驗證方法及系統具有下列特點：係可以相對於該檢驗項目之正常範圍設定該誤差值及該誤判值，以畫分出該第一臨界範圍、該第二臨界範圍、該第一誤判範圍及該第二誤判範圍，並透過檢查各該受檢人員於前後二次的檢驗數據，是否分別落在該第一鄰界範圍/該第二臨界範圍，與落在該第一誤判範圍/該第二誤判範圍，以通知後一次的檢驗數據落在該第一臨界範圍與該第二臨界範圍的受檢人員重新進行檢驗，以各自產生該重測檢驗報告；若各該重測檢驗報告與相對應的該後一次的檢驗數據皆落在相同的該第一誤判範圍/該第二誤判範圍時，將該誤差值設定成該誤判值。如此，係可以根據該檢測儀器自身的精準度調整相對於該正常範圍的誤差值，具有提高檢驗結果可靠性的功效。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.
茲配合圖式將本發明實施例詳細說明如下，其所附圖式主要為簡化之示意圖，僅以示意方式說明本發明之基本結構，因此在該等圖式中僅標示與本發明有關之元件，且所顯示之元件並非以實施時之數目、形狀、尺寸比例等加以繪製，其實際實施時之規格尺寸實為一種選擇性之設計，且其元件佈局形態有可能更為複雜。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.
以下各實施例的說明是參考附加的圖式，用以例示本發明可據以實施的特定實施例。本發明說明書中，除非明確地描述為相反的，否則詞語“包含”將被理解為意指包含所述元件，但是不排除任何其它元件。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.
請參照圖1所示，其係本發明醫檢數據驗證方法的一較佳實施例，係包含：一檢驗步驟S1、一分析步驟S2、一圈選步驟S3、一重測步驟S4及一調整步驟S5。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.
該檢驗步驟S1用以指定一檢驗項目，並透過一檢測儀器在數個不同時期對數名受檢人員分別根據該檢驗項目進行量測，以產生各該受檢人員的一檢驗報告，該檢驗報告具有一識別代號及各該時期的一檢驗數據，其中，該數個不同時期可以為不同年份，該識別代號可以為一流水號，但不以此為限。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.
在另一實施例中，該檢驗步驟S1用以指定另一檢驗項目，並透過另一檢測儀器根據該另一檢驗項目對該數名受檢人員在數個不同時期的檢體分別進行檢測，以產生各該受檢人員的一檢驗報告，該檢驗報告具有該識別代號及該數個檢體各自的一檢驗數據。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.
該分析步驟S2用以設定該檢驗項目的一第一臨界範圍及一第二臨界範圍，該第一臨界範圍小於該檢驗項目的一正常範圍之下限值，且不小於該下限值減去一誤差值；該第二臨界範圍大於該正常範圍之上限值，且不大於該上限值加上該誤差值。其中，該誤差值會根據該檢驗項目而有所不同，以該檢驗項目為血液中所含白血球數量為例，該白血球的正常範圍落在4500～10000（cu.mm），該誤差值可以設定為10，此時，該第一臨界範圍落在4490～4500之間，該第二鄰界範圍落在10000～10010之間。受檢人員的檢驗數據落在該第一臨界範圍或該第二臨界範圍內時，仍將該受檢人員認定為白血球數量正常。值得注意的是，在本實施中，該第一臨界範圍為包含4490但不包含4500，該第二鄰界範圍為包含10010但不包含10000。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.
檢查各該受檢人員於前後連續二次的檢驗報告，若一連續時間內具有超過一百分比的受檢人員於前一次的檢驗數據落在該第一臨界範圍，且於後一次的檢驗數據落在一第一誤判範圍，該第一誤判範圍小於該第一臨界範圍且與該下限值相差一誤判值，或是，於前一次的檢驗數據落在該第二臨界範圍，且於後一次的檢驗數據落在一第二誤判範圍，該第二誤判範圍大於該第一臨界範圍且與該上限值相差該誤判值，則執行後續的圈選步驟S3及重測步驟S4，而啟動重測機制，以確認是否為該檢測儀器之精準度失常所造成，並可以將該檢驗數據落在該第一臨界範圍與該第二臨界範圍之間的受檢人員認定為檢驗正常，以及將該檢驗數據落在該第一誤判範圍或該第二誤判範圍的受檢人員認定為檢驗異常；否則，則可以不需執行額外的作動並繼續檢查其他受檢人員。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.
舉例而言，該連續時間可以設定成3天，該百分比可以設定成30%，但不以此為限。另一方面，該誤判值亦會根據該檢驗項目而有所不同，以該檢驗項目為血液中所含白血球數量為例，該誤判值可以為該誤差值的1～3倍，在本實施例中，該誤判值可以設定為30，此時，該第一誤判範圍落在4470～4490之間，該第二誤判範圍落在10010～10030之間。值得注意的是，在本實施中，該第一誤判範圍為包含4470但不包含4490，該第二誤判範圍為包含10030但不包含10010。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.
該圈選步驟S3用以當其中一受檢人員的檢驗數據落在該第一誤判範圍或該第二誤判範圍內時，將該連續時間中，於該後一次的檢驗數據落在該第一臨界範圍與該第二臨界範圍的數名受檢人員進行標註，以根據該數名受檢人員的識別代號產生一圈選名單。較佳地，該圈選步驟S3可以增加圈選天數，以圈選更多的受檢人員，在本實施例中，可以將該連續時間以及其前後各至少一天中（例如：5天，即總共13天），於該後一次的檢驗數據落在該第一臨界範圍與該第二臨界範圍的數名受檢人員進行標註，以產生該圈選名單。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.
該重測步驟S4用以通知該圈選名單中的數名受檢人員分別以該檢測儀器重新進行檢驗，以各自產生一重測檢驗報告。另一方面，當該檢測儀器為對該受檢人員在數個不同時期的檢體進行檢測時，該重測步驟S4用以通知該圈選名單中的該數名受檢人員分別以該檢測儀器重新進行檢驗，意即，採集各該受檢人員相對於該另一檢驗項目的新檢體，以對各該受檢人員的新檢體進行檢驗；或是以該檢測儀器重新檢驗該數名受檢人員各自於後一次的檢體，意即，對各該受檢人員之前所採集保存的檢體重新進行檢驗，以各自產生該重測檢驗報告。在本實施例中，可以透過社群軟體、簡訊或電話等方式進行通知，但不以此為限。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.
該調整步驟S5用以比對各該重測檢驗報告與相對應的該後一次的檢驗數據是否皆落在相同的該第一誤判範圍或該第二誤判範圍，若比對結果為是，意即，該檢測儀器的檢驗精準度超出該檢驗項目所設定之誤差值的可容許範圍，故將該誤差值設定成該誤判值，以將該檢測儀器的該第一臨界範圍之下限值擴大至該第一誤判範圍之下限值，以及將該第二臨界範圍之上限值擴大至該第二誤判範圍之上限值，並將該後一次的檢驗數據落在調整後的該第一誤判範圍或該第二誤判範圍內的受檢人員重新認定為檢驗正常；若比對結果為否，則可以不需額外執行作動。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.
請參照圖2所示，其係本發明醫檢數據驗證系統的一較佳實施例，係包含：一檢測儀器1及一數據分析儀器2，該檢測儀器1電性連接該數據分析儀器2。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
該檢測儀器1用以指定一檢驗項目，並在數個不同時期分別對數名受檢人員根據該檢驗項目進行量測，以產生各該受檢人員的一檢驗報告，該檢驗報告具有一識別代號及各該時期的一檢驗數據。其中，該數個不同時期可以為不同年份，該識別代號可以為一流水號，但不以此為限。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.
該檢驗項目以心臟檢查為例，該檢測儀器1可以為心電圖檢測儀，該檢驗數據可以為將該檢測儀器1所量測到的心電訊號轉換成QRS複合波，並以一高通濾波器進行雜訊的濾除後所輸出之數值。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.
在另一實施例中，該檢測儀器1可以對該數名受檢人員在數個不同時期的檢體分別進行檢測，以產生各該受檢人員的檢驗報告，該檢驗報告具有該識別代號及該數個檢體各自的檢驗數據。其中，該數個檢體可以各自存放於一試管中。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.
舉例而言，該檢驗項目可以檢查血液中的各種血球數量檢測，則該檢測儀器1可以為全自動血球分析儀，且該檢驗數據可以為白血球數量。此外，在其他實施例中，根據不同的檢驗項目，該檢測儀器1還可以為全自動生化儀、全自動化血液凝固分析儀、自動生化免疫分析儀、全自動尿液分析儀、滲透壓分析儀或全自動糞便潛血分析儀，且分別取得相對應的檢驗數據，為本發明相關領域中具有通常知識者可以理解。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.
該數據分析儀器2電性連接該檢測儀器1，並具有一資料庫單元21及一處理單元22，其中，該資料庫單元21用以儲存該數個檢驗報告，該處理單元22電性連接該資料庫單元21，並用以設定該檢驗項目的一第一臨界範圍及一第二臨界範圍，該第一臨界範圍小於該檢驗項目的一正常範圍之下限值，且不小於該下限值減去一誤差值，該第二臨界範圍大於該正常範圍之上限值，且不大於該上限值加上該誤差值。舉例而言，該數據分析儀器2可以為電腦主機，但不以此為限。The
該處理單元22檢查各該受檢人員於前後連續二次的檢驗報告，若一連續時間內具有超過一百分比的受檢人員於前一次的檢驗數據落在該第一臨界範圍，且於後一次的檢驗數據落在一第一誤判範圍，該第一誤判範圍小於該第一臨界範圍且與該下限值相差一誤判值，該處理單元22將該連續時間中，於該後一次的檢驗數據落在該第一臨界範圍與該第二臨界範圍的數名受檢人員進行標註，以根據該數名受檢人員的識別代號產生一圈選名單。The
另一方面，該處理單元22檢查各該受檢人員於前後連續二次的檢驗報告，若該連續時間內具有超過該百分比的受檢人員於該前一次的檢驗數據落在該第二臨界範圍，且於該後一次的檢驗數據落在一第二誤判範圍，該第二誤判範圍大於該第二臨界範圍且與該上限值相差該誤判值，該處理單元22亦可以將該連續時間中，於該後一次的檢驗數據落在該第一臨界範圍與該第二臨界範圍的數名受檢人員進行標註，以根據該數名受檢人員的識別代號產生該圈選名單。On the other hand, the
此外，該處理單元22可以將該檢驗數據落在該第一臨界範圍與該第二臨界範圍之間的受檢人員認定為檢驗正常，以及將該檢驗數據落在該第一誤判範圍或該第二誤判範圍的受檢人員認定為檢驗異常，並將各該受檢人員的檢驗結果與相對應的該檢驗報告儲存記錄於該資料庫單元21中。In addition, the
較佳地，該處理單元22可以增加圈選天數，以圈選更多的受檢人員，在本實施例中，可以將該連續時間以及其前後各至少一天中，於該後一次的檢驗數據落在該第一臨界範圍與該第二臨界範圍的數名受檢人員進行標註，以產生該圈選名單。Preferably, the
在本實施例中，該處理單元22可以將該連續時間設定成3天，以及將該百分比設定成30%，但不以此為限。另一方面，該誤差值與該誤判值會根據該檢驗項目的種類而有所不同，以該檢驗項目為血液中所含白血球數量為例，該誤差值可以為10，而該誤判值可以為30。In this embodiment, the
該資料庫單元21另儲存該數名受檢人員各自的聯絡方式，該處理單元22透過該聯絡方式通知該圈選名單中的數名受檢人員分別以該檢測儀器1重新進行檢驗，以各自產生一重測檢驗報告。詳言之，當該檢測儀器1為對該受檢人員在數個不同時期的檢體進行檢測時，該處理單元22通知該圈選名單中的該數名受檢人員分別以該檢測儀器1重新進行檢驗，意即，採集各該受檢人員相對於該另一檢驗項目的新檢體，以對各該受檢人員的新檢體進行檢驗；或是以該檢測儀器1重新檢驗該數名受檢人員各自於後一次的檢體，意即，對各該受檢人員之前所採集保存的檢體重新進行檢驗，以各自產生該重測檢驗報告。The
該處理單元22比對各該重測檢驗報告與相對應的該後一次的檢驗數據，是否皆落在相同該第一誤判範圍或該第二誤判範圍，若比對結果為是，該處理單元22將該誤差值設定成該誤判值，以將該檢測儀器1的該第一臨界範圍之下限值擴大至該第一誤判範圍之下限值，以及將該第二臨界範圍之上限值擴大至該第二誤判範圍之上限值，並將該後一次的檢驗數據落在調整後的該第一誤判範圍或該第二誤判範圍內的受檢人員重新認定為檢驗正常，並對應調整儲存於該資料庫單元21中的紀錄；若比對結果為否，則該處理單元22可以不需執行額外的作動。The
本發明的醫檢數據驗證系統之數據分析儀器2，還可以具有一輸出單元23電性連接該處理單元22，該處理單元22控制該輸出單元23顯示記錄於該資料庫單元21中各該受檢人員的檢驗結果。舉例而言，該輸出單元23可以為顯示螢幕。The
承上所述，本發明的醫檢數據驗證方法及系統，係可以相對於該檢驗項目之正常範圍設定該誤差值及該誤判值，以畫分出該第一臨界範圍、該第二臨界範圍、該第一誤判範圍及該第二誤判範圍，並透過檢查各該受檢人員於前後二次的檢驗數據，是否分別落在該第一鄰界範圍/該第二臨界範圍，與落在該第一誤判範圍/該第二誤判範圍，以通知後一次的檢驗數據落在該第一臨界範圍與該第二臨界範圍的受檢人員重新進行檢驗，以各自產生該重測檢驗報告；若各該重測檢驗報告與相對應的該後一次的檢驗數據皆落在相同的該第一誤判範圍/該第二誤判範圍時，將該誤差值設定成該誤判值。如此，係可以根據該檢測儀器自身的精準度調整相對於該正常範圍的誤差值，具有提高檢驗結果可靠性的功效。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.
上述揭示的實施形態僅例示性說明本發明之原理、特點及其功效，並非用以限制本發明之可實施範疇，任何熟習此項技藝之人士均可在不違背本發明之精神及範疇下，對上述實施形態進行修飾與改變。任何運用本發明所揭示內容而完成之等效改變及修飾，均仍應為下述之申請專利範圍所涵蓋。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.
﹝本發明﹞ 1:檢測儀器 2:數據分析儀器 21:資料庫單元 22:處理單元 23:輸出單元 S1:檢驗步驟 S2:分析步驟 S3:圈選步驟 S4:重測步驟 S5:調整步驟﹝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
[圖1]為本發明之醫檢數據驗證方法的方法流程圖； [圖2]為本發明之醫檢數據驗證系統的系統方塊圖。 [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:檢測儀器 1: Testing instrument
2:數據分析儀器 2: Data analysis instrument
21:資料庫單元 21: Database unit
22:處理單元 22: Processing unit
23:輸出單元 23: Output unit
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| WO2004099913A2 (en) * | 2003-04-30 | 2004-11-18 | Becton, Dickinson And Company | Method and system for validating changes in medical practice, procedures and product choice |
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| TW201118632A (en) * | 2009-11-30 | 2011-06-01 | Sien-Shih Chang | Method and system of judging health examination data and recording medium thereof |
| TW201430602A (en) * | 2013-01-21 | 2014-08-01 | Univ Nat United | Health status evaluation method and health status evaluation system applying the same |
| TWM627507U (en) * | 2022-02-15 | 2022-05-21 | 資研科技股份有限公司 | Medical inspection data verification system |
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| WO2004099913A2 (en) * | 2003-04-30 | 2004-11-18 | Becton, Dickinson And Company | Method and system for validating changes in medical practice, procedures and product choice |
| CN101373186A (en) * | 2007-08-24 | 2009-02-25 | 希森美康株式会社 | Diagnosis support system for cancer, diagnosis support information providing method for cancer, and control system |
| TW201118632A (en) * | 2009-11-30 | 2011-06-01 | Sien-Shih Chang | Method and system of judging health examination data and recording medium thereof |
| TW201430602A (en) * | 2013-01-21 | 2014-08-01 | Univ Nat United | Health status evaluation method and health status evaluation system applying the same |
| TWM627507U (en) * | 2022-02-15 | 2022-05-21 | 資研科技股份有限公司 | Medical inspection data verification system |
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