1. Field of the Invention
The present invention relates to an automatic analyzer for qualitatively and quantitatively analyzing a biological sample such as blood and urine. The invention more particularly relates to an automatic analyzer and an automatic analysis system, each of which has functions to easily perform a process for a series of operations including a special treatment to take for an unusual condition, a request for a re-measurement after the special treatment, and confirmation of the result of the re-measurement when an unusual condition attributable to the states of a sample or a reagent during analysis occurs.
2. Description of the Related Art
A typical automatic analyzer receives a constant amount of a sample and a constant amount of a reagent, causes the sample and the reagent to react in a reaction vessel and measures absorbance or fluorescence. The automatic analyzer analyzes samples of patients in accordance with multiple analysis items and therefore uses multiple reagents to treat the samples. When samples of patients and reagents are set to the automatic analyzer and measurements are completed without any trouble during analyses, there is no special problem. However, the following unusual conditions may occur during the analyses since the analyses are clinical examinations.
These unusual conditions are not attributed to the automatic analyzer and are unavoidable as long as a routine measurement is performed in a clinical examination. Operations that are to be performed after occurrence of any of the unusual conditions are different from a normal routine operation.
For example, it is assumed that analyses are requested to be performed in accordance with fifteen analysis items for a certain sample and that clogging of a sample probe is detected during the analysis for the fifth item. In that case, the analyses for the subsequent analysis items for which measurement is to be performed will be interrupted. An operator extracts the sample from the automatic analyzer and removes a foreign material such as fibrin. Even if the operator wants to immediately resume the analysis for any of such analysis items, the analysis cannot be performed again using the same IDs since sample IDs will be duplicated during a period of time until results of the first four items for which sampling has been completed are output. Thus, the operator operates the automatic analyzer for the unusual condition, e.g., sets the sample from a general sample to an urgent sample or manually enters a virtual ID into the automatic analyzer. After that, the operator operates the automatic analyzer to cause the automatic analyzer to perform a re-measurement on the sample. The result of the re-measurement is reported without being distinguished from the result of a measurement performed in the normal routine operation.
JP-A-8-262031 discloses an automatic analyzer that displays an identification of the occurrence of an unusual condition during such an analysis in accordance with the degree of emergency.
The contents of a treatment to be performed for an unusual condition are complicated as described above and are entrusted to the operator. Thus, the operator may erroneously enter data and perform erroneous operation. Even when such an error is found, the conventional technique cannot trace why and where the error took place.
In addition, it is a cumbersome task to search samples one by one for finding a sample subjected to a special treatment to take for an unusual condition and confirm measurement results of the samples.
When an unusual condition attributable to the states of a sample or a reagent occurs, the operator understands the status of the automatic analyzer, identifies and deals with the cause of the unusual condition, and performs a series of tasks for re-measurement. In the course of the process, the automatic analyzer may be stopped and restarted whereas only the sample or a part of items is problematic and the automatic analyzer may not need to be stopped. In order to treat only a specific sample, the operator extracts the sample from the automatic analyzer and performs troubleshooting in order to introduce a special treatment to take for an unusual condition into a normal operation (normal treatment to be performed by the automatic analyzer) of the automatic analyzer. A typical introduction method used is to measure the sample as an urgent sample.
The special treatment for such an unusual condition is different from a routine operation and complicated. Thus, the operator may erroneously enter data and erroneously operate the automatic analyzer. Even when such an error is found, the conventional technique cannot trace why and where the error took place. In addition, the result obtained through the special treatment is reported without being distinguished from the result of a measurement performed in the normal routine operation. Thus, it is a cumbersome task to search samples one by one for finding a sample subjected to a special treatment for such an unusual condition and confirm measurement results of the samples.
An object of the present invention is to provide an automatic analyzer and automatic analysis system, each of which is capable of being rapidly handled when an unusual condition occurs and ensuring traceability during a treatment for the unusual condition.
When a lack of reagent, clogging of a sample probe, a failure in reading a barcode, a lack of sample, a calibration error, or a quality control error occurs or the reagent is expired during a measurement performed for a certain analysis item, an analysis for the analysis item is regarded as a failure. In order to perform the analysis for the analysis item, it is necessary to request a re-analysis with a measurement number (sequence number) changed and with a sample ID and a patient ID unchanged or to request a re-analysis with a sample ID and a patient ID changed as another sample. When the result of the sample thus measured is displayed on the basis of sample IDs and patient IDs, the analysis result is displayed as if the result of the sample was that of another sample. Thus, the re-analysis result cannot be determined to be either the result of a re-measurement performed due to an error or the initial measurement result. To avoid this problem, the automatic analyzer according to the present invention includes an analyzer for analyzing a sample in accordance with a first analysis item and in response to a first request; and a storage mechanism for associating, with identification information used to identify a sample subjected to a special treatment, measurement data on the sample analyzed by the analyzer in accordance with the first analysis item and in response to a second request different from the first request, and storing the measurement data associated with the identification information.
The operator does not need to stop the automatic analyzer during a process for a series of operations to understand the status of the automatic analyzer, identify and deal with the cause of the unusual condition and perform a re-measurement. In order to treat only a sample accompanied by an unusual condition, the operator handles the sample and operates the automatic analyzer in order to introduce a special treatment to take for an unusual condition into a normal operation (normal treatment to be performed by the automatic analyzer) of the automatic analyzer. A process that is performed on the sample subjected to the special treatment can be clarified separately from that performed on the sample subjected to the normal treatment.
In order to clarify the process that is performed on the sample subjected to the special treatment, the following functions are required.
1. The automatic analyzer has the following screens required when an unusual condition occurs.
(1) Dedicated special treatment trace screen that displays contents of a process for an unusual condition
(2) Dedicated re-measurement request screen that is used to restart an analysis after an occurrence of an unusual condition
(3) Dedicated measurement result screen that displays the result of a measurement of a sample subjected to a special treatment to take for an unusual condition and is used to confirm and approve the measurement result
2. A sample subjected to a special treatment to take for an unusual condition is measured through troubleshooting by an operator. Thus, a process that is to be performed before the measurement is different from a process that is to be performed on a normal sample. It is necessary that the measurement result of the sample subjected to the special treatment be confirmed and approved. Thus, an entrance and exit for the sample subjected to the special treatment are different from those for a sample subjected to the normal treatment. The entrance means an entrance of the data base, while the exit means an exit of the data base. The entrance and the exit vary depending on whether or not the sample is subjected to a special treatment to take for an unusual condition. The automatic analyzer has a database dedicated for a sample subjected to a special treatment for an unusual condition to manage a measurement process.
3. The automatic analyzer records contents of an unusual condition, a sample number after a special treatment for an unusual condition, a sample ID, a setting position, a measurement item, a measurement result and the like in the database dedicated for a sample accompanied by an unusual condition in order to ensure traceability.
4. The automatic analyzer has a function of guiding a process for each unusual condition in order to clarify a method for coping with the unusual condition.
5. The automatic analyzer has a function of adding a mark to the measurement result based on the type of an unusual condition in order to identify the measurement result.
The operator copes with an unusual condition in accordance with a guidance displayed for each cause of the unusual conditions on the re-measurement request screen to reduce the risk of an error in operation. The measurement result of a sample subjected to the special treatment for the unusual condition is stored in a database different from a database storing measurement results of normally treated samples and displayed on the dedicated measurement result screen, which improves operability of the automatic analyzer. In addition, a process for confirmation and approval by an administrator is performed. Thus, only the measurement result of a sample subjected to a special treatment to take for an unusual condition, which is confirmed and approved by the administrator, can be reported to an external computer. Furthermore, the automatic analyzer ensures traceability by recording the contents of the special treatment.
An embodiment of the present invention is described below with reference to the accompanying drawings.
An automatic analyzer according to the embodiment of the present invention has a data processor. The data processor is described below with reference to
The outline of a work flow of the automatic analyzer is described with reference to
In contrast, when an unusual condition occurs (for example, when a reagent is not sufficient, or the sample is stuck, or a barcode is not correctly read), the operator understands the status of the automatic analyzer, identifies and deals with the cause of the unusual condition, and performs a series of handling for re-measurement. In the case where the sample accompanied by the unusual condition is treated without a suspension of the automatic analyzer in this process, the operator handles the sample and operates the automatic analyzer in order to introduce a special treatment to take for an unusual condition into a normal operation (normal treatment that is to be performed by the automatic analyzer) of the automatic analyzer.
The sample in question is registered in the database dedicated for a sample subjected to a special treatment and displayed on the dedicated measurement result screen 1. The operator selects the corresponding sample on the measurement result screen 1 and opens the dedicated re-measurement request screen 9. After that, the operator instructs the automatic analyzer to perform a re-measurement in accordance with a guidance displayed on the re-measurement request screen 9. The result of the re-measurement is displayed on the measurement result screen 1. The operator confirms the result of the re-measurement on the measurement result screen 1. In addition, an administrator approves the result of the re-measurement. In this case, the administrator can confirm the contents of the special treatment in chronological order by opening the special treatment trace screen 10. Therefore, the sample subjected to a special treatment can be handled as a normal sample through the confirmation and the approval. The result of the sample subjected to a special treatment handled as the normal sample is transferred into the database dedicated for a normal sample and output to the external computer.
Next, the measurement result screen 1, the re-measurement request screen 9 and the special treatment trace screen 10, which are dedicated for a sample accompanied by an unusual condition, are described below.
Detail examples are described below for each of causes of unusual conditions.
The sample treated in the case (1) is registered in the measurement result screen 1 dedicated for a sample accompanied by an unusual condition. The status field for the sample treated in the case (1) indicates “trouble”. The operator selects the sample treated in the case (1) on the measurement result screen 1 and presses the re-measurement button 5. Then, the re-measurement request screen 9 is displayed. The re-measurement request screen 9 shows items (shown in
The results of the measurement are output and stored in the database for a sample accompanied by an unusual condition. This database dedicated is different from the database that is dedicated for a normal sample and designed to store a sample normally treated. The results are displayed on the measurement result screen 1. The operator selects a target sample and confirms a measured value of the target sample for each item. After that, when the operator presses the confirmation button 4, the status field for the sample indicates “confirmation”. When the sample is required to be re-measured, the operator needs to press the re-measurement button 5. When the operator confirms samples subjected to all operations of the special treatment and then presses an approval button 6, data on the samples are erased from the screen 1, transferred into the database dedicated for a normal sample and output to the external computer in real time or collectively. The automatic analyzer records therein operations of the special treatment (shown in
In the flow shown in
The sample treated in the case (2) is registered in the measurement result screen 1. The status field for the sample treated in the case (2) indicates “trouble”. The operator selects the sample treated in the case (2) on the measurement result screen 1 and presses the re-measurement button 5. Then, the re-measurement request screen 9 is displayed. The re-measurement request screen 9 shows items (shown in
The results of the re-measurement are output and stored in the database dedicated for a sample accompanied by an unusual condition. This database is different from the database that is dedicated for a normal sample and designed to store a sample normally treated. The output results are displayed on the measurement result screen 1. The results of the measurement of the sample, which are confirmed and approved by the administrator, are transferred into the database dedicated for a normal sample and output to the external computer in real time or collectively. The automatic analyzer records unusual conditions shown in FIG. 7 such as contents of the alarm and screen operations performed to avoid the duplication of the IDs by using, as a trigger, the generation of the alarm indicative of the lack of the sample. Then, the recorded unusual conditions are displayed on the special treatment trace screen 10.
In the flow shown in
The sample treated in the case (3) is registered in the measurement result screen 1, and the status field for the sample treated in the case (3) indicates “trouble”. The operator selects the sample treated in the case (3) on the measurement result screen 1 and presses the re-measurement button 5. Then, the re-measurement request screen 9 is displayed. The re-measurement request screen 9 shows items (shown in
The results of the re-measurement are output and stored in the database dedicated for a sample accompanied by an unusual condition. This database is different from the database that is dedicated for a normal sample and designed to store a sample normally treated. The output results are displayed on the measurement result screen 1. The results of the measurement of the sample, which are confirmed and approved by the administrator, are transferred into the database dedicated for a normal sample and output to the external computer in real time or collectively. The automatic analyzer records therein unusual conditions shown in
In the flow shown in
The sample treated in the case (4) is registered in the measurement result screen 1. The status field for the sample treated in the case (4) indicates “trouble”. The operator selects the sample treated in the case (4) on the measurement result screen 1 and presses the re-measurement button 5. Then, the re-measurement request screen 9 is displayed. The re-measurement request screen 9 shows items (shown in
The results of the re-measurement are output and stored in the database dedicated for a sample accompanied by an unusual condition. This database is different from the database that is dedicated for a normal sample and designed to store a sample normally treated. The output results are displayed on the measurement result screen 1. The results of the measurement of the samples, which are confirmed and approved by the administrator, are transferred into the database dedicated for a normal sample and output to the external computer in real time or collectively. The automatic analyzer records therein unusual conditions shown in
In the flow shown in
The sample for which the alarm indicative of the lack of the reagent is generated is registered in the measurement result screen 1. The status field for the sample treated in the case (5) indicates “trouble”. The operator selects the sample treated in the case (5) on the measurement result screen 1 and presses the re-measurement button 5. Then, the re-measurement request screen 9 is displayed. The re-measurement request screen 9 shows items (shown in
The results of the measurement are output and stored in the database dedicated for a sample accompanied by an unusual condition. This database is different from the database that is dedicated for a normal sample and designed to store a sample normally treated. The output measurement results are displayed on the measurement result screen 1. The measurement results of the sample, which are confirmed and approved by the administrator, are transferred into the database dedicated for a normal sample and output to the external computer in real time or collectively. The automatic analyzer records therein unusual conditions shown in
In the flow shown in
The foregoing description discloses that the measurement results of each of the samples subjected to the special treatment for the unusual conditions are displayed on the measurement result screen dedicated for a sample subjected to a special treatment. The samples subjected to the special treatment may be distinguished from normally treated samples by adding identification marks to the samples subjected to the special treatment. In addition, the samples subjected to the special treatment may be distinguished from normally treated samples by adding, to the samples subjected to the special treatment, marks that are different based on the unusual conditions. In the foregoing description, the occurrences of the unusual conditions are determined by the generations of the alarms. Alternatively, the operator may register any sample as a sample accompanied by an unusual condition and register any item as a special item to ensure that the sample is determined to be in an unusual condition.
Number | Date | Country | Kind |
---|---|---|---|
2008-107389 | Apr 2008 | JP | national |