WO1999005634A1 - Clinical examination analyzer - Google Patents

Abstract

A clinical examination analyzer comprising a data base storage section (14) adapted to store therein the measured values of the examination items of a sample of a subject together with the identification information on the subject and the examination date and information on the department or ward a checking criterion setting section (16) adapted to set criterion values for checking the measured values for each department or ward on the basis of the number of days having passed from the previous examination date of the same subject and measured values belonging to the same department or ward which are stored in the database storage section (14), and a checking section (18) adapted to evaluate the propriety of the current measured values on the basis of the number of days having elapsed from the previous examination of the same subject and the propriety checking criterion values set for each department or ward.

Description

 Description Clinical laboratory analyzers Technical field

 The present invention relates to a clinical test analyzer, and more particularly to a clinical test analyzer having a check function for discriminating test result data (measurement value) having high abnormality due to a test error or the like from proper test result data. . Background art

 As a clinical laboratory analyzer, a blood test such as a blood test is performed on each sample (sample to be tested for each patient), and the test result data of the biochemical test is accumulated on a database, etc., and the test results are collected. When assessing inspections, an inspection abnormality check that discriminates between the inspection result data that is highly abnormal due to an inspection error and the appropriate inspection result data using an individual management method such as the previous value check Those having a function are known.

 In this clinical test analyzer, if the test result data (previous value) performed for a certain 3 test items is stored in the database, Calculate the difference and Z or ratio between the test result and the previous value. If the difference and Z or ratio exceed the preset allowable range (standard value for checking the change in measured value), check the test result. It is determined that the data is abnormal.

 In addition, the latest inspection result data is checked for comparison with the preset upper and lower limits (standard values for whether the measured value is too large or too small) and exceeds the upper limit. In the case where it is less than the lower limit, it is determined that the abnormality of the inspection result data is high.

In order to perform anomaly judgment (inspection abnormality check) by the individual management method such as the previous value check as described above at a high hit rate, it is necessary to check the appropriateness of the measured value change that becomes the criterion. In view of this, it is necessary to appropriately set the reference value for checking whether the reference value or the measured value is too large or too small, and in consideration of this, Japanese Patent Application Laid-Open No. 8-147473 / 96 discloses the same subject. There is shown a clinical test analyzer that sets a check reference value for measurement value change and a check value for suitability of measurement value over / under according to the number of days elapsed since the previous test date. The clinical test analyzer disclosed in Japanese Patent Application Laid-Open No. 8-1477396 achieves the initial purpose and performs the abnormal test at a relatively high hit rate. There is room for improvement to achieve even higher hit rates.

 In view of this, the present inventor conducted further statistical considerations on test result data, and found that the distribution of measured values of clinical tests such as blood tests, for example, the distribution of measured values of TP (total protein) test The situation was found to be different for internal medicine with more visceral diseases than for rheumatology and surgery, which are usually considered to have fewer visceral diseases.

 Therefore, in order to perform inspection abnormal check at a higher hit rate, it is necessary to check whether the measured value changes according to internal medicine, rheumatology, surgery, etc. It has been reached that the reference values should be set individually. The present invention has been made by paying attention to the above-mentioned points, and the reference value for the propriety check in the inspection abnormality check by the individual management method such as the previous value check is individually determined according to internal medicine, rheumatology, surgery, etc. The purpose of the present invention is to provide a clinical test analyzer capable of further increasing the hit rate of a test by setting the test value and obtaining a highly reliable test result with a highly reliable measurement value. Disclosure of the invention

The clinical test analyzer according to the present invention includes: storage means for storing a measurement value for each test item of a specimen together with identification information of a subject, a test date, and information on a type of a consultation department; For the same subject stored in the storage means, the number of days elapsed since the previous examination date and the same consultation department, the validity of the measurement value for each consultation department or ward department based on the measurement value belonging to the same ward department Consultation departments that set check standard values By the check criteria setting means and the consultation department / ward department pass / fail check criteria setting means, the elapsed test days of the same subject and the number of examinations for each consultation department become the pass / fail check reference values set for each ward department. And evaluation means for evaluating the suitability of the current measured values based on this.

 Further, in the clinical test analyzer according to the present invention, the check reference value is for checking an upper limit value and a lower limit value of an allowable measured value, that is, for checking upper and lower limits. Further, in the clinical laboratory analyzer according to the present invention, the check reference value is an allowable limit value for a difference and / or a ratio of a current value to a previous value, that is, a value for a previous value (Del-Yu) check. is there.

 Further, in the clinical test analyzer according to the present invention, the means for setting the checkability standard for each consultation department / ward department may be for the same consultation department or the same ward department, and may be used for all the same test items having the same number of days elapsed. Obtain frequency distribution data or scatter data between the previous measurement value and the current measurement value for each predetermined measurement value width, and obtain the frequency distribution data or scatter From last day, the limit value for the previous value chinic is set for each of the same measurement values or for each predetermined measurement value range.

 Further, in the clinical examination analyzer according to the present invention, the consultation department / ward department suitability check criteria setting means considers a correlation with another test item for each same consultation department or same ward department. This sets the appropriateness check reference value for checking between items. BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 is a functional configuration diagram showing an embodiment of a clinical test analyzer according to the present invention. FIG. 2 is an explanatory diagram showing a reception input screen in the clinical test analyzer according to the present invention. FIG. 3 is a flowchart for explaining the operation of the clinical test analyzer according to the present invention. BEST MODE FOR CARRYING OUT THE INVENTION Hereinafter, an embodiment of a clinical test analyzer according to the present invention will be described in detail with reference to the accompanying drawings.

 FIG. 1 shows one embodiment of a clinical test analyzer according to the present invention. The clinical laboratory analyzer includes a reception information input unit 10 for inputting clinical test reception information, a measurement value input unit 12 for inputting clinical test measurement values, a database storage unit 14, a consultation department and a ward department. It has a separate compliance check reference value setting unit 16, a check unit (evaluation means) 18, a display device 20, a printer 22, and a log file storage unit 24 that accumulates and retains the history of inspection results. I have.

 The reception information input section 10 is a reception input screen, as shown in Fig. 2, where the reception date, reception number, patient ID, name, date of birth, gender, dialysis Include presence / absence, physician's name, request department (consultation department), ward department, and test items. The measurement value input unit 12 captures the measurement value of each test item of the sample by the biochemical testing device online or offline together with the identification information of the subject and the test date.

 Here, a blood test device is assumed as the biochemical test device, and the test items are TP (total protein), ALB (albumin), Na (sodium), K (potassium), C1 (chlorine). ), Ca (calcium), BUN (urea nitrogen), creatinine, GLU (glucose), Amy (amylase), GOT (glutamic acid-oxaloacetic transaminase), GPT (glutamic acid-pyruvate transaminase), T-one BIL (total pyrilvin), Alp (alkaline phosphatase), CK (creatine kinase), LDH (lactate dehydrogenase) and the like.

 The database storage unit 14 stores the measured values for each test item of the sample from the received information input from the received information input unit 10 and the measured values for each test item of the sample input from the measured value input unit 12. Is stored in the form of a database file together with the ward department type information together with the identification information of the subject, the examination date, and the department information.

Consultation departments' ward department compliance check reference value setting unit 16 stores the same subject in the database storage unit 14 as the number of days elapsed since the previous examination date of the same subject, Is used to set the reference value for the appropriateness of the measured values for each consultation department or ward department based on the measured values belonging to the same ward.The limit value for single item upper / lower limit clinic, the limit value for delta check, and the Set limits for interim clinic by consultation department or ward department.

 The upper limit and lower limit for the single item upper and lower limit check are the upper limit and lower limit of the measurement values that are allowed according to the number of days elapsed since the previous test date of the same subject, by consultation department or ward department for each test item. Is set.

 The limits for Dell evening check are acceptable limits for the difference and Z or ratio of the latest value to the previous value, and the setting of these limits is for the same department or ward. For all measured values of the same test item with the same elapsed days, the frequency distribution data between the previous measurement value and the current measurement value is acquired for each identical measurement value or for each predetermined measurement value width, From the frequency distribution data or the scatter data, the measurement is performed for each same measurement value or for each predetermined measurement value width.

 In setting the delta check limit value, the following setting method can be adopted.

 (1) From the frequency distribution data, calculate the maximum frequency value or total frequency value for each identical measurement value or each predetermined measurement value width, and calculate the minimum frequency value that satisfies the specified ratio for the maximum frequency value or total frequency value. Measurement difference and Z or ratio.

 (2) From the frequency distribution data, the same measured value is obtained, or the maximum frequency value or total frequency and sum value are calculated for each predetermined measurement value width, and the sum of the distribution frequency from the outer edge of the frequency distribution is calculated. The maximum frequency value is the measured value difference and the ratio or ratio of the minimum frequency value satisfying a predetermined ratio with respect to the total frequency value.

(3) The frequency distribution data is normally distributed for the same measurement value or for each predetermined measurement value width, and the minimum frequency value that satisfies the predetermined ratio with respect to the maximum frequency value or the total frequency value of the normally distributed frequency distribution data. The measured value difference and Z or ratio, or the frequency distribution data were normalized for the same measurement value or for each predetermined measurement value width, and the sum of the distribution frequencies from the outer edge of the normal distribution was normalized. Maximum degree of frequency distribution data The numerical value is the measured value difference and Z or ratio of the smallest frequency value that satisfies the specified ratio to the total frequency value.

 In addition, if it is necessary to explain these setting methods in more detail, refer to Japanese Patent Application Laid-Open No. 8-147396.

 The limit value for inter-item check is set in consideration of the correlation with other test items for the same department or ward.

 The check section 18 receives the current measurement value from the measured value input section 12 and receives the pass / fail ward pass / fail criterion value for each consultation department and ward department from the clinic / ward department pass / fail check reference value setting section 16. Perform single item upper / lower limit check, delta check, and inter-item check. The single item upper / lower limit check is based on the upper limit of the relevant department and the ward department that the current measurement value entered from the measurement value input section 1 and 2 is set by the clinic department And whether the current measured value is smaller than the lower limit of the relevant department or ward set by the department / ward department compliance check reference value setting unit 16 The check section 18 warns that if the current measurement value is greater than the upper limit value or if the current measurement value is smaller than the lower limit value, the current measurement value deviates from the check reference value. Is output to the display device 20 and the printer 22 together with information indicating the reason, that is, an error message.

 In the delta check, the difference between the current measurement value input from the measurement value input unit 12 and the previous measurement value stored in the database storage unit 14 (this value-the previous value) is determined by the consultation department and ward. It is determined by whether or not it is within the ascending or descending limit value of the relevant consultation department / ward department set by the departmental appropriateness check reference value setting section 16.The check section 18 is limited If the value is equal to or greater than the value, the current measurement value is deviated from the check reference value, and a warning is output to the display device 20 and the printer 22 together with information indicating the reason, that is, an error message.

If the difference between the current value and the previous value is a positive sign, the delta check is an ascending change, so it is determined whether or not the difference value is within the ascending limit value. If the difference between the value and the previous value is a minus sign, it is a decreasing change, It is determined whether or not the difference value is within the lower limit value. Similar determination can be made by using a ratio between the previous value and the current value, or a combination of the difference and the ratio.

 The inter-item chips are set by the current measurement values of the two test items that have a correlation from the measurement value input unit 12 and the check reference value setting unit 16 by the consultation department / ward department. This is done by comparing the threshold values for tips between the relevant consultation departments and ward departments, and if the current measurement value exceeds the limit value, If the value exceeds the check reference value, a warning is output to the display device 20 and the printer 22 together with information indicating the reason, that is, an error message.

 Next, the operation of the clinical test analyzer according to the present embodiment will be described in detail with reference to a flowchart shown in FIG.

 First, the current measured value is obtained from the measured value input unit 12 (step S10), and reception information is obtained from the database storage unit 14 (step S20). Next, it is determined whether or not the limit value for each consultation department / ward department is defined in the consultation department / ward department compliance check reference value setting unit 16 (step S30).

 If the limit value for each consultation department and ward department is not defined, the default limit value existing in the consultation department and ward department appropriateness check reference value setting unit 16 is acquired (step S40). . On the other hand, if the limit value for each consultation department and ward department is defined, the limit value for the relevant consultation department and ward department is set from the consultation department and ward department compliance check reference value setting unit 16. Acquire (step S50).

 Next, the check unit 18 compares the current measured value from the measured value input unit 12 with the obtained limit value to perform a single item upper / lower limit check, a delta check, and a check between items. (Step S60).

 Finally, the check results are displayed on the display device 20 on a screen, the check list is printed by the printer 22, and the information is output to the log file storage unit 24 as history information (step S 70). .

As described above, the clinical test analyzer according to the present embodiment uses the date of the last measurement. Calculate the number of days elapsed from the measurement date and the current measurement date, and set the reference values for single-item check, delta check, and item-to-item check based on the number of days elapsed and the previous value for each consultation department or ward department. Since the current value is evaluated based on the check reference value for each department or ward, the tendency of the test result data for each test item can be reflected in the evaluation judgment, and as a result, the The inspection rate can be improved and more reliable inspection results can be obtained.

 As described above, according to the clinical test analyzer according to the present invention, the number of days that have elapsed since the previous examination date of the same subject and the measurement values belonging to the same consultation department or the same ward department stored in the storage means Since the criteria for the appropriateness of the measurement values are set for each consultation department or ward department, the tendency of the examination department or ward department of the test result data for each test item can be reflected in the evaluation judgment, and as a result, The hit rate of inspection can be improved, and more reliable inspection results can be obtained.

 Further, according to the clinical test analyzer of the present invention, the check reference value is an upper limit value and a lower limit value of an allowable measurement value, that is, a limit value of a single item check, and a limit value of the single item check. With regard to the setting, the tendency of the examination department or ward department of the examination result data of each examination item is reflected, and as a result, the hit rate of examination can be improved, and more reliable examination results can be obtained.

According to the clinical test analyzer of the present invention, the check reference value is an allowable limit value of a difference and / or a ratio of a current value to a previous value, that is, a limit value of a delta check. As regards the setting of the limit value, the tendency of the examination result data for each examination department or ward department in the examination result data is reflected, and as a result, the test hit rate can be improved and more reliable examination results can be obtained. it can. Further, according to the clinical test analyzer according to the present invention, all the measured values for the same examination department or the same ward and for the same elapsed days of the same test item, and for each of the same measured values, Is used to obtain frequency distribution data or scatter data between the previous measurement value and the current measurement value for each predetermined measurement value width. Limitation of delta check for each measured value or specified measured value width Since the threshold value is set, the trend of each ward department is statistically accurately reflected in the setting of the delta check, and the trend of each ward department on the test result data for each test item is as follows. The inspection hit rate can be improved, and more reliable inspection results can be obtained.

 Further, according to the clinical test analyzer according to the present invention, the pass / fail check reference value is set in consideration of the correlation with other test items for the same consultation department or the same ward department. Regarding the setting of the limit value of the check, the tendency of the test result data of each test item for each consultation department or ward department is statistically accurately reflected, and as a result, the hit rate of the test can be improved, More reliable test results can be obtained. Industrial applications

 As described above, the clinical test analyzer according to the present invention further improves the hit rate of the test by individually setting the suitability check reference value in the test abnormality check by the individual management method such as the previous value check. It is especially useful for internal medicine, rheumatology, surgery, etc., and is suitable for obtaining high test results, high credibility, and high reliability with measured values. .

Claims

The scope of the claims 1. A storage means for storing the measurement value of each test item of the sample together with the identification information of the subject, the examination date, and the information on the type of department or the type of ward,  Same as the number of days elapsed since the previous examination date of the same subject stored in the storage means —Measurement department and ward department compliance criteria setting means for setting appropriateness criteria for the above-mentioned measurement values for each department or ward department based on the values belonging to the department or department.  Evaluation to evaluate the suitability of the current measurement values based on the number of days of examination of the same subject by the above-mentioned consultation department and ward department compliance criteria setting means and the compliance check value set for each consultation department or ward department. Means,  A clinical test analyzer comprising: 2. The consultation department / ward department pass / fail criterion setting means sets the pass / fail check reference value in consideration of correlation with other examination items for each same consultation department or same ward department. The clinical laboratory analyzer according to claim 1, wherein: 3. The clinical test analyzer according to claim 1, wherein the check reference value is an upper limit value and a lower limit value of an allowable measured value. 4. The consultation department / ward department pass / fail check standard setting means sets the pass / fail check reference value in consideration of correlation with other examination items for each same consultation department or same ward department. 4. The clinical test analyzer according to claim 3, wherein: 5. The clinical laboratory analyzer according to claim 1, wherein the check reference value is an allowable limit value for a difference between the present value and the previous value and for Z or ratio. --1 o .WO 99/05634 PCT / JP98 / 01008 1 1 6. The consultation department and ward department compliance check criteria setting means sets the compliance check reference value in consideration of correlation with other examination items for each of the same department or ward department. 6. The clinical test analyzer according to claim 5, wherein: 7. The means for setting the appropriateness criteria for each consultation department and ward department are for the same consultation department or the same ward department, and for all the measurement values of the same examination item with the same age, For each predetermined measurement value width, there is frequency distribution data between the previous measurement value and the current measurement value, or scatter data is obtained, and this frequency distribution data is the same as scatter data. 6. The clinical test analyzer according to claim 5, wherein the limit value is set for each predetermined measurement value width. 8. The above-mentioned consultation department and ward department compliance check criteria setting means sets the above-mentioned compliance clinic reference value in consideration of correlation with other test items for each same department or same ward department. 15. The clinical test analyzer according to claim 7, wherein: 20 twenty five