JPH1145302A - Clinical inspection analysis device - Google Patents

Abstract

PROBLEM TO BE SOLVED: To obtain a highly reliable clinical result by individually setting appropriateness check reference values in inspection abnormality check by the individual management method of previous value check in accordance with an internal medicine department, a rheumatic department and the like. SOLUTION: The measurement values of an object to be examined for respective inspection items are stored in a database storage part 14 with identification information of a person to be inspected, an inspection date, information by individual medical examination departments or information by individual ward departments. The appropriateness check reference values of the measurement values by individual medical examination departments or by the individual ward departments are set in an appropriateness check reference setting part by individual medical examination departments/ward departments 16 from the number of lapse days from the previous inspection date of the same examined person, and the measurement value belonging to the same medical examination department or the same ward department. Then, the appropriateness of the measurement values of this time is evaluated based on the number of inspection lapse days of the same inspected person and the appropriateness check reference values which are set by the individual medical examination departments or the individual wards by the appropriateness check reference setting part by individual medical examination departments/individual wards 16. Thus, the tendency for the respective medical examination departments or the respective wards of inspection result data by respective inspection items can be reflected on evaluation judgment, and the hit ratio of inspection can be improved.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a clinical test analyzer and, more particularly, to a check function for discriminating test result data (measurement value) having a high abnormality due to a test error or the like from proper test result data. And a clinical test analyzer having the same.

[0002]

2. Description of the Related Art As a clinical test analyzer, a blood test or other biochemical test is performed on each sample (test sample of each patient), and the test result data of the biochemical test is stored in a database or the like. When evaluating the results, there is known an inspection abnormality check function that discriminates inspection result data with high anomalies due to inspection errors and appropriate inspection result data by individual management methods such as previous value check etc. ing.

[0003] In this clinical test analyzer, when test result data (previous value) performed for a certain test item is stored in a database, the current (latest) test result and the last Calculate the difference and / or ratio from the value, and set the difference and / or ratio to a preset allowable range (reference value for checking whether the measured value changes).
If the number exceeds the threshold, it is determined that the abnormality of the inspection result data is high.

[0004] Also, regarding the latest inspection result data,
A comparison check is performed with a preset allowable upper limit value and a lower limit value (a reference value for checking whether the measured value is too large or too small). If the upper limit value is exceeded or the measured value is lower than the lower limit value, the inspection result data is checked. It is determined that the abnormality is high.

[0005] In order to perform an abnormality determination (inspection abnormality check) by an individual management technique such as the previous value check as described above at a high hit rate, a reference value of a measurement value change as a criterion or a reference value of a measurement value is determined. It is necessary to properly set the appropriateness check reference value for over / under, and in view of this,
Japanese Patent Application Laid-Open No. 8-147396 discloses a clinic for setting a suitability check reference value for a change in a measured value and a suitability check reference value for an excessively small or small measured value in accordance with the number of days elapsed from a previous examination date of the same subject. A test analyzer is shown.

[0006]

Problems to be Solved by the Invention
The clinical test analyzer disclosed in Japanese Patent Publication No. 6 achieves the initial purpose and performs a test abnormality check at a relatively high hit rate. However, the clinical test analyzer is improved to perform the test abnormality check at a higher hit rate. There is room for

In view of this, the inventor of the present application has conducted further statistical considerations on test result data, and has found that the distribution of measured values of clinical tests such as blood tests, for example, TP (total protein) test measurement The distribution of the values was found to be different between internal medicine, which has many visceral patients, and rheumatology and surgery, which usually have few visceral patients.

Therefore, the inspection abnormality check is further performed
In order to perform with a high hit rate, it is necessary to set individually the appropriateness check reference value of the measured value change and the appropriateness check reference value of the excessively small or small measured value according to internal medicine, rheumatology, surgery, etc. That was reached.

The present invention has been made by paying attention to the above-mentioned points, and a reference value for aptitude check in an inspection abnormality check by an individual management method such as a previous value check is individually determined according to internal medicine, rheumatology, surgery, and the like. It is an object of the present invention to provide a clinical test analyzer capable of further increasing the hit rate of a test and obtaining a highly reliable test result with a highly reliable measurement value.

[0010]

In order to achieve the above object, a clinical test analyzer according to claim 1 of the present invention comprises:
Storage means for storing the measurement values for each test item of the specimen together with the identification information of the subject and the examination date and the information on the type of the consultation department or the information on the type of the ward; and the last time of the same subject stored in the storage means. A pass / fail ward department pass / fail criterion setting means for setting pass / fail criterion values of the measured values by consultation department or ward department from measured values belonging to the same consultation department or the same ward department as the number of days elapsed from the examination date; Evaluation means for evaluating the suitability of the current measurement value based on the elapsed days of the examination of the same subject and the suitability check reference value set for each consultation department or ward department by the consultation department / ward department suitability check reference setting means. And

According to a second aspect of the present invention, there is provided the clinical test analyzer according to the first aspect, wherein the check reference value is an upper limit value and a lower limit value of an allowable measured value, that is, This is for checking the upper and lower limits.

According to a third aspect of the present invention, there is provided the clinical test analyzer according to the first aspect, wherein the check reference value includes a difference between a current value and a previous value and / or a ratio. A possible limit value, that is, for checking a previous value (delta).

According to a fourth aspect of the present invention, there is provided a clinical test analyzer according to the third aspect, wherein the suitability check reference setting means for each of the departments to be examined and the ward departments is the same. Frequency distribution data or scattered data between the previous measurement value and the current measurement value for all measurement values for the same test item and for the same elapsed days for the same test item or for each predetermined measurement value width. The limit value for the previous value check is set for each identical measurement value or for each predetermined measurement value width from the frequency distribution data or the scatter data.

According to a fifth aspect of the present invention, there is provided a clinical test analyzer according to any one of the first to fourth aspects, wherein the suitability check criterion setting means for each consultation department / ward department is provided. The suitability check reference value for the inter-item check is set in consideration of the correlation with other examination items for the same consultation department or the same ward department.

[0015]

BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a perspective view of a clinical test analyzer according to an embodiment of the present invention.

FIG. 1 shows an embodiment of a clinical test analyzer according to the present invention. Clinical laboratory analyzers
A reception information input unit 10 for inputting reception information of a clinical test;
A measurement value input unit 12 for inputting a measurement value of a clinical test, a database storage unit 14, a suitability check reference value setting unit 16 for each consultation department / ward department, a check unit (evaluation means) 18,
It has a display device 20, a printer 22, and a log file storage unit 24 for accumulating and retaining the history of inspection results.

The reception information input unit 10 is a reception input screen as shown in FIG. 2, and includes reception date, reception number, patient ID, name, date of birth, sex, dialysis as reception information of a clinical test. Presence / absence, doctor's name, request department (consultation department), ward department,
Capture inspection items. The measurement value input unit 12 captures a 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 apparatus is assumed as a biochemical test apparatus, and test items are TP (total protein), ALB (albumin), Na (sodium), K
(Potassium), Cl (chlorine), Ca (calcium), B
UN (urea nitrogen), creatinine, GLU (glucose), Amy (amylase), GOT (glutamic acid-
Oxaloacetate transaminase), GPT (glutamate-pyruvate transaminase), T-BIL
(Total bilirubin), Alp (alkaline phosphatase), CK (creatine kinase), LDH (lactate dehydrogenase) and the like.

The database storage unit 14 stores, for each test item of the sample, the reception information input from the reception information input unit 10 and the measurement value for each test item of the sample input from the measurement value input unit 12. Is stored in the database file format together with the identification information of the subject, the examination date, and the information on the department to be examined or the information on the ward department.

The reference value setting unit 16 determines whether or not the same subject has been stored in the database storage unit 14 since the previous examination date and the number of days belonging to the same department or ward. Based on the values, a reference value for the appropriateness of the measured value is set for each consultation department or ward department, and a limit value for a single item upper / lower limit check, a limit value for a delta check, and a limit value for a check between items are set. Set by consultation department or ward department.

The upper limit and the lower limit for the single item upper / lower limit check are defined as the upper limit and the lower limit of the measured value that are allowed according to the number of days elapsed from the previous test date of the same subject for each examination item or for each examination item. Set by ward department.

The limit value for the delta check is an allowable limit value for the difference and / or the ratio of the latest value to the previous value. Obtain frequency distribution data or scattered data between the previous measurement value and the current measurement value for each measurement value or for each predetermined measurement width for all measurement values for the same elapsed days of the inspection item, and obtain the frequency distribution data or The measurement is performed for each identical measurement value or for each predetermined measurement value width from the scatter data.

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

(1) From the frequency distribution data, a maximum frequency value or a total frequency value is calculated for each identical measurement value or for each predetermined measurement value width, and a minimum frequency value satisfying a predetermined ratio with respect to the maximum frequency value or the total frequency value. Measurement differences and / or ratios.

(2) A maximum frequency value or a total frequency value is calculated from the frequency distribution data for each of the same measured values or for each predetermined measurement value width, and the sum of the distribution frequencies from the outer edge of the frequency distribution is the maximum frequency value or the frequency. The measured value difference and / or ratio of the smallest frequency value that satisfies a predetermined ratio to the total value.

(3) The frequency distribution data is subjected to normal distribution for each of the same measured values or for each predetermined measured value width, and the minimum frequency satisfying a predetermined ratio with respect to the maximum frequency value or the frequency sum total value of the normally distributed frequency distribution data. A frequency distribution in which the measured value differences and / or ratios or the frequency distribution data are made into a normal distribution for each of the same measurement values or for each predetermined measurement value width, and the sum of the distribution frequencies from the outer edge of the distribution in the normal distribution is made a normal distribution. The measured value difference and / or ratio of the smallest frequency value that satisfies a predetermined ratio with respect to the maximum frequency value or total frequency value of the data.

For a more detailed explanation of these setting methods, see Japanese Patent Application Laid-Open No. 8-147396.

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

The check unit 18 receives the current measured value from the measured value input unit 12 and the suitability check reference value setting unit 16 for each department and ward department. Item upper / lower limit check, delta check, and inter-item check are performed.

The single item upper / lower limit check is performed in the measured value input unit 1
This measurement value input from Step 2 is used by the department / applicability check reference value setting unit 16 for each department / ward
It is determined whether or not the measured value is larger than the upper limit value of the ward department, and whether or not the current measurement value is smaller than the lower limit value of the corresponding consulted department or ward department set by the suitability check reference value setting unit 16 for each department. If the current measurement value is larger than the upper limit value or the current measurement value is smaller than the lower limit value, the checking unit 18 warns that the current measurement value has deviated from the check reference value. With information indicating the reason,
That is, the error message is output to the display device 20 and the printer 22.

In the delta check, the difference between the current measurement value input from the measurement value input section 12 and the previous measurement value stored in the database storage section 14 (current value-previous value) is determined according to the consultation department / ward department. The determination is performed by determining whether or not the value is within the ascending limit value or the descending limit value of the relevant consulting department / ward set by the propriety check reference value setting unit 16. 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, if the difference between the current value and the previous value is a positive sign, the delta check is an ascending change.
It is determined whether or not the difference value is within the rising limit value. If the difference value between the current value and the previous value is a negative sign, the difference value is a decreasing change, and the difference value is determined to be the falling limit value. It is determined whether it is within the range. Also, the ratio between the previous value and the current value,
Alternatively, a similar determination can be made by using a combination of the difference and the ratio.

The inter-item check is performed by checking the current measured values of two correlated test items input from the measured value input unit 12 and the corresponding check-up value set by the appropriateness check reference value setting unit 16 for each department / ward. The check unit 18 warns that the current measurement value is out of the check reference value if the current measurement value exceeds the limit value. 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 the flowchart shown in FIG.

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

If the limit value for each consultation department / ward department is not defined, the default limit value existing in the suitability check reference value setting unit 16 for each consultation department / ward department is acquired (step S40). On the other hand, when the limit value for each consultation department / ward department is defined, the limit value of the corresponding consultation department / ward department is acquired from the consultation department / ward department suitability check reference value setting unit 16 ( Step S50).

Next, the checking unit 18 compares the current measurement value from the measurement value input unit 12 with the acquired limit value, and performs a single item upper / lower limit check, a delta check, and an inter-item check ( Step S60).

Finally, the check results are displayed on a screen of the display device 20, 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 S70).

As described above, the clinical test analyzer of the present embodiment calculates the number of days elapsed from the previous measurement date and the current measurement date, and performs single item check, delta The check reference value for the check and inter-item check is set for each consultation department or ward department, and the current value is evaluated based on the check reference value for each consultation department or ward department. This can be reflected in the evaluation judgment, and as a result, the inspection hit rate can be improved, and a more reliable inspection result can be obtained.

[0040]

As described above, according to the clinical test analysis apparatus according to the first aspect of the present invention, the same medical examination as the number of days elapsed from the previous examination date of the same subject stored in the storage means is obtained. Based on the measurement values belonging to the department or the same ward department, the appropriateness check reference value of the measurement value is set for each consultation department or ward department, so the tendency of the examination result data of each examination item for each consultation department or ward department is reflected in the evaluation judgment As a result, the inspection hit rate can be improved, and a more reliable inspection result can be obtained.

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

According to the clinical test analysis apparatus of the third aspect of 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 limit value of a delta check. With regard to the setting of the limit value of the delta check, the tendency of the examination result data of each examination item for each examination department or ward department is reflected, and as a result, the examination hit rate can be improved, and the examination result with higher reliability can be obtained. Can be obtained.

According to the clinical test analyzer according to the fourth aspect of the present invention, all the measured values of the same examination department or the same ward and having the same elapsed days of the same test item are determined by the same measured value or by the predetermined measurement. For each price range, frequency distribution data or scatter data between the previous measurement value and the current measurement value is obtained, and a delta check is performed for each identical measurement value or predetermined measurement value width from this frequency distribution data or scatter data. Since the limit value is set, the tendency of the test result data for each examination item for each consultation department or ward department regarding the setting of the delta check limit value is statistically accurately reflected, and as a result, the test hit rate is reduced. Can be improved,
More reliable test results can be obtained.

According to the clinical test analyzer according to the fifth aspect of the present invention, the suitability check reference value is set in consideration of the correlation with other test items for each of the same consultation department or the same ward department. Regarding the setting of the limit value of the interim check, the tendency of the test result data of each examination item for each consultation department or ward department is statistically accurately reflected, and as a result, the test hit rate can be improved and more reliable Inspection results can be obtained.

[Brief description of the drawings]

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 illustrating the operation of the clinical test analyzer according to the present invention.

[Explanation of symbols]

 10 Reception information input unit 12 Measured value input unit 14 Database storage unit 16 Acceptance check reference value setting unit by consultation department / ward department 18 Check unit 20 Display device 22 Printer 24 Log file storage unit

Claims (5)

[Claims] 1. A storage means for storing a measurement value of each test item of a specimen together with identification information of a subject, an examination date, and consultation department type information or ward department type information, and the same storage means stored in the storage means. Based on the number of days elapsed from the previous examination date of the subject and the measurement value belonging to the same consultation department or the same ward department, set the validity check reference value of the measurement value for each consultation department or ward department. Check criteria setting means, and the suitability of the current measurement value based on the number of days passed for examination of the same subject and the suitability check reference value set for each consultation department or ward department by the suitability check criteria setting means for each consultation department / ward department. A clinical test analyzer, comprising: an evaluation unit that evaluates: 2. 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 measurement value. 3. The clinical test analyzer according to claim 1, wherein the check reference value is an allowable limit value for a difference and / or a ratio of a current value to a previous value. 4. The consultation department / ward department suitability check reference setting means is for the same consultation department or the same ward department,
Obtain frequency distribution data or scattered data between the previous measurement value and the current measurement value for each measurement value or every predetermined measurement value width for all measurement values for the same test item with the same elapsed days, and obtain this frequency distribution data. 4. The clinical test analyzer according to claim 3, wherein the limit value is set for each of the same measured values or for each predetermined measured value width from the scattered data. 5. The suitability check criterion setting means for each consultation department and ward department sets the suitability check criterion value in consideration of a correlation with another test item for each same consultation department or same ward department. The clinical test analyzer according to any one of claims 1 to 4, wherein