JP7710340B2 - Inspection support method, inspection support device, and computer program - Google Patents

Description

The present invention relates to a test support method, a test support device, and a computer program for supporting clinical tests that are performed by collecting samples from subjects.

Some clinical tests involve taking a sample such as blood from a subject and performing various tests on the sample. For example, the sample is taken at a medical institution such as a hospital. Although the clinical test may be performed at the medical institution where the sample was taken, in many cases, some or all of the clinical test is performed at a testing institution outside the medical institution. Conventionally, systems for processing information related to clinical tests have been developed. Patent Document 1 discloses a system for accurately grasping the status of work related to clinical tests and enabling appropriate work improvements.

Patent No. 5613495

Currently, clinical testing systems are developed for each medical institution and testing institution. At medical institutions, specimen containers for holding specimens are given identification information associated with the subject. For example, the type of specimen container is determined according to the individual test, a label recording unique identification information for the specimen container is created, and the label is affixed to the specimen container. The collected specimen is placed in the specimen container, and the specimen container is transported to the testing institution. Collecting a specimen involves a lot of work and takes time. In addition, when collecting a specimen, there is a risk that the specimen containers holding the specimens may be mixed up. If the specimen containers are mixed up, at least part of the clinical test may become impossible.

The present invention was made in consideration of the above circumstances, and its purpose is to provide a test support method, test support device, and computer program that can reduce the work involved in collecting samples and prevent mix-ups of sample containers for holding samples.

The testing support method according to the present invention is a method for supporting work for a clinical test using a specimen collected from a subject, characterized in that: a specimen container for containing a specimen is pre-recorded with container identification information including container type information indicating the type of the specimen container and information specific to the specimen container for identifying the specimen container; test identification information for identifying a clinical test and container type information of a specimen container for containing a specimen required for the clinical test are stored in association with each other; the test identification information and the container type information are output before collecting a specimen; the container identification information is obtained from the specimen container before collecting the specimen; and the obtained container identification information is output in association with the test identification information and the container type information.

The test support device according to the present invention is a device for supporting work for clinical testing using a sample collected from a subject, and includes a memory unit that stores test identification information for identifying a clinical test and container type information indicating the type of sample container for containing the sample required for the clinical test in association with each other, an output unit that outputs the test identification information and the container type information, and an acquisition unit that acquires container identification information from a sample container that is pre-recorded in the sample container and includes the container type information of the sample container and information that is unique to the sample container and identifies the sample container, and the output unit outputs the acquired container identification information in association with the test identification information and the container type information.

The computer program according to the present invention is characterized in that it causes a computer to execute a process of outputting test identification information for identifying a clinical test and container type information indicating the type of specimen container for containing a specimen required for the clinical test, acquiring container identification information that is pre-recorded in a specimen container and includes container type information of the specimen container and information that is unique to the specimen container and identifies the specimen container, and outputting the acquired container identification information in association with the test identification information and container type information.

The present invention has excellent effects such as reducing the work involved in collecting samples for clinical testing and preventing mix-ups of sample containers containing collected samples.

FIG. 1 is a conceptual diagram showing a procedure for performing a clinical test. 1 is a schematic diagram showing an example of a specimen container in which a specimen is contained; FIG. 1 is a schematic diagram showing a configuration of an inspection support system. 2 is a block diagram showing an example of an internal functional configuration of a storage device; 2 is a block diagram showing an example of an internal functional configuration of the collection support device. FIG. FIG. 13 is a conceptual diagram showing an example of the contents of a sample table before a sample is collected. 11 is a flowchart showing an example of a procedure of a process for supporting sample collection executed by the test support system. FIG. 13 is a schematic diagram showing an example of a collection support image. FIG. 13 is a schematic diagram showing an example of an image displaying a request to confirm personal information. FIG. 13 is a schematic diagram showing an example of a display of an image of a sample container. FIG. 13 is a schematic diagram showing an example of an error indicating that the type of the sample container is different. 13 is a schematic diagram showing an example of a collection support image after a specimen container ID is acquired. FIG. 13 is a schematic diagram showing an example of an image representing a confirmation request for a confirmation item. FIG. 13 is a schematic diagram showing an example of a collection support image in a state where all sample container IDs have been acquired. FIG. FIG. 13 is a schematic diagram showing an example of outputting the collected volume of a specimen. FIG. 13 is a conceptual diagram showing an example of the contents of a sample table after a sample has been collected. 13 is a block diagram showing another example of the internal functional configuration of the collection support device. 13 is a flowchart showing an example of a procedure for sorting sample containers.

The present invention will now be described in detail with reference to the drawings showing embodiments thereof.
FIG. 1 is a conceptual diagram showing a procedure for performing a clinical test. In a medical institution such as a hospital or a clinic, the contents of a clinical test for a subject are determined, and a test request in which the contents of the clinical test are recorded is created. The clinical test in this embodiment is a specimen test performed using a specimen collected from the subject. The contents of the clinical test are determined by a doctor who examines the subject. The specimen is, for example, a body fluid such as blood, saliva, nasal mucus, tears, sweat, spinal fluid, or urine. Alternatively, the specimen is, for example, a nasal swab, a laryngeal swab, stool, or cells. Next, a specimen is collected from the subject. In this embodiment, an example in which the specimen is blood is mainly shown.

The specimen is sent from the medical institution to a testing institution. The testing institution may be an institution outside the medical institution, or a testing department within the medical institution where the examination was performed. The testing institution receives the sent specimen. Next, a clinical test is performed according to the test request. In the clinical test, tests are performed on the specimen. The test results are then reported to the medical institution. The test support method according to this embodiment supports the implementation of clinical tests, and in particular supports the work performed when collecting a specimen from a subject.

A sample collected from a subject is contained in a sample container. FIG. 2 is a schematic diagram showing an example of a sample container 6 in which a sample is contained. For example, the sample container 6 is a blood collection tube. The sample container 6 is formed of a transparent material such as glass or resin, and is tubular. One end of the sample container 6 is closed, and the other end is open. After a sample such as blood is placed inside the sample container 6, a lid is attached to the sample container 6, and the inside of the sample container 6 is sealed. The sample container 6 may have a shape other than tubular, and may be formed of a non-transparent material. A label 61 on which a sample container ID is recorded is attached to the sample container 6. For example, a barcode representing the sample container ID is written on the label 61.

The specimen container ID includes information indicating the type of specimen container 6 and information that is unique to the specimen container 6 and is used to identify the specimen container 6. The specimen container ID corresponds to container identification information. The specimen container ID may be recorded on the label 61 in a form other than a barcode, such as a two-dimensional code. The specimen container ID may be recorded directly on the specimen container 6, such as by directly writing a barcode on the specimen container 6. The specimen container ID may be recorded on the specimen container 6 as electronic data. For example, an RF (Radio Frequency) tag that stores the specimen container ID may be attached to the specimen container 6, or a memory that stores the specimen container ID may be attached to the specimen container 6.

The specimen container 6 is delivered to the medical institution with the specimen container ID recorded in advance. For example, the specimen container 6 is delivered to the medical institution with a label 61 with the specimen container ID recorded thereon in advance. The medical institution does not assign a specimen container ID to the specimen container 6, record the specimen container ID in a database, or attach a label 61 to the specimen container 6. The specimen collected from the subject is contained in the specimen container 6. The specimen container 6 containing the specimen is transported from the medical institution to the testing institution, and the specimen is sent from the medical institution to the testing institution.

Figure 3 is a schematic diagram showing the configuration of the test support system 100. The test support system 100 is a system for executing the test support method. The test support system 100 includes a storage device 1 for storing data. The storage device 1 is connected to a communication network N such as the Internet. The medical institution 20 includes an input device 201 for inputting a test request including the contents of a clinical test, and a collection support device 2 for supporting the work of collecting a sample. The input device 201 is operated by a medical professional such as a doctor to input a test request. The collection support device 2 is used by an operator 51 such as a doctor, nurse, assistant nurse, or clinical laboratory technician who performs the work of collecting a sample from a subject. The input device 201 and the collection support device 2 are connected to the communication network N. The input device 201 and the collection support device 2 transmit and receive data to and from the storage device 1 via the communication network N.

The testing facility 30 is provided with a receipt support device 3 that supports the task of receiving samples, and an output device 4 that outputs the status of the clinical test. The receipt support device 3 is used by a worker 52 who receives samples sent from the medical institution 20. The output device 4 is used by a user such as a technician who performs clinical testing, and outputs the progress or results of the clinical test. The receipt support device 3 and the output device 4 are connected to a communication network N. The receipt support device 3 and the output device 4 transmit and receive data to and from the storage device 1 via the communication network N. A plurality of receipt support devices 3 and output devices 4 may be used at the testing facility 30.

The test support system 100 can be used by multiple medical institutions 20. The test support system 100 can include an input device 201 and a collection support device 2 provided in each of the multiple medical institutions 20. The test support system 100 can also be used by multiple testing institutions 30. The test support system 100 can include a receipt support device 3 and an output device 4 provided in each of the multiple testing institutions 30.

The input device 201 is a computer such as a PC (personal computer), a smartphone, or a tablet computer. The input device 201 has an operation unit into which information is input by a user, and a medical professional operates the operation unit to input a test request. For example, a doctor examines a subject, determines the contents of a clinical test based on the examination results, and a test request including the determined contents of the clinical test is input to the input device 201. The input device 201 transmits the input test request to the storage device 1 via the communication network N. The storage device 1 receives and stores the transmitted test request. In this manner, a test request is created. Although one input device 201 is shown in FIG. 3, multiple input devices 201 may be used in the medical institution 20.

Figure 4 is a block diagram showing an example of the internal functional configuration of the storage device 1. The storage device 1 is a computer such as a server device. The storage device 1 includes a calculation unit 11, a memory 12, a storage unit 13, a drive unit 14, and a communication unit 15. The calculation unit 11 is configured using, for example, a CPU (Central Processing Unit), a GPU (Graphics Processing Unit), or a multi-core CPU. The calculation unit 11 may be configured using a quantum computer. The memory 12 stores temporary data generated in association with calculation. The memory 12 is, for example, a RAM (Random Access Memory). The storage unit 13 is non-volatile, for example, a hard disk or a non-volatile semiconductor memory. The drive unit 14 reads information from a recording medium 10 such as an optical disk or a portable memory. The communication unit 15 communicates with other devices via a communication network N.

The calculation unit 11 causes the drive unit 14 to read the computer program 131 recorded on the recording medium 10, and stores the read computer program 131 in the memory unit 13. The calculation unit 11 executes processing required for the storage device 1 in accordance with the computer program 131. The computer program 131 may be a computer program product. The computer program 131 may be downloaded from outside the storage device 1. Alternatively, the computer program 131 may be pre-stored in the memory unit 13. In these cases, the storage device 1 does not need to have a drive unit 14.

The storage device 1 may be provided in the medical institution 20, the testing institution 30, or a location other than the medical institution 20 and the testing institution 30. The storage device 1 may be configured with multiple computers, data may be stored in a distributed manner by the multiple computers, and processing may be executed in a distributed manner by the multiple computers. The storage device 1 may be realized by using cloud computing, or may be realized by multiple virtual machines provided in a single computer.

The memory unit 13 stores a subject DB (database) 132 that records data on subjects. The subject DB 132 records personal information such as name, age, and sex for each subject. The subject DB 132 also records information related to clinical tests for each subject, such as a subject ID for identifying the subject in clinical tests, a test request history, a sample collection history, and a history of the results of the clinical tests. For example, if a subject is a person from whom blood is difficult to draw for some reason, information indicating that the subject is a person from whom blood is difficult to draw is recorded in the subject DB 132. The memory unit 13 stores a sample table 133 that records information related to samples taken from subjects. Information related to the samples is recorded in the sample table 133 according to the creation of a test request and the collection of the samples.

Figure 5 is a block diagram showing an example of the internal functional configuration of the collection support device 2. The collection support device 2 is a computer such as a PC, a smartphone, or a tablet computer. The collection support device 2 includes a calculation unit 21, a memory 22, a drive unit 23, a storage unit 24, an operation unit 25, a display unit 26, a reading unit 27, and a communication unit 28. The calculation unit 21 is configured using, for example, a CPU, a GPU, or a multi-core CPU. The calculation unit 21 may be configured using a quantum computer. The memory 22 stores temporary data generated in association with the calculation. The memory 22 is, for example, a RAM. The drive unit 23 reads information from a recording medium 200 such as an optical disk or a portable memory. The storage unit 24 is non-volatile, for example, a hard disk or a non-volatile semiconductor memory.

The operation unit 25 receives input of information such as text by receiving an operation from the operator 51. The operation unit 25 is, for example, a touch panel, a pen tablet, a keyboard, or a pointing device. The display unit 26 displays an image. The display unit 26 is, for example, a liquid crystal display or an EL display (Electroluminescent Display). The operation unit 25 and the display unit 26 may be integrated. The reading unit 27 reads the specimen container ID recorded in the specimen container 6. For example, the reading unit 27 is a camera, a barcode reader, or a reader that reads information recorded in an RF tag using short-range wireless communication. The reading unit 27 corresponds to the acquisition unit. The communication unit 28 communicates with the storage device 1 via the communication network N. The storage device 1 transmits information from the communication unit 15, and the collection support device 2 receives the information via the communication unit 28 and displays the information on the display unit 26. The communication unit 15 of the storage device 1 and the display unit 26 of the collection support device 2 correspond to the output unit.

The calculation unit 21 causes the drive unit 23 to read the computer program 241 recorded on the recording medium 200, and stores the read computer program 241 in the storage unit 24. The calculation unit 21 executes processing required for the collection support device 2 according to the computer program 241. The computer program 241 may be a computer program product. The computer program 241 may be downloaded from outside the collection support device 2. For example, the computer program 241 may be downloaded from the storage device 1. The computer program 241 may be stored in the memory 22, not in the storage unit 24. For example, the computer program 241 may be downloaded when processing related to the test support method is executed, stored in the memory 22, and erased from the memory 22 when processing related to the test support method is completed. The computer program 241 may be stored in advance in the storage unit 24. In these cases, the collection support device 2 may not have the drive unit 23.

Although one collection support device 2 is shown in FIG. 3, multiple collection support devices 2 may be used in the medical institution 20. Multiple workers 51 operate multiple collection support devices 2, and each collection support device 2 communicates with the storage device 1. When multiple medical institutions 20 exist, the storage device 1 communicates with the input devices 201 and collection support devices 2 provided in the multiple medical institutions 20 via the communication network N.

The process executed by the test assistance system 100 is described below. A medical professional operates the input device 201, and a test request is input to the input device 201. The input device 201 transmits the test request to the storage device 1. The storage device 1 receives the test request transmitted from the input device 201 via the communication unit 15. The calculation unit 11 of the storage device 1 records the test request in the subject DB 132 in association with the subject ID. The calculation unit 11 determines one or more test items with specific test contents specified according to the content of the test request, and records information about the sample required to execute the test item in the sample table 133.

Figure 6 is a conceptual diagram showing an example of the contents of the sample table 133 before a sample is collected. In the sample table 133, the sample container type, sample container ID, status, total sample collection volume, test item, dispensing volume, confirmation item, confirmation item content, specification of whether confirmation of the confirmation item is mandatory or optional, and confirmation input URL (Uniform Resource Locator) are recorded in association with the test request ID. The test request ID is information for identifying one clinical test requested for one subject. The test request ID corresponds to the test identification information. The test request ID is information unique to one clinical test. The calculation unit 11 records the test request ID in the subject DB 132 in association with the subject ID. In the example shown in Figure 6, "001" is recorded as the test request ID.

The specimen container type indicates the type of specimen container 6 for containing a specimen collected from a subject. The specimen container type corresponds to the container type information. The specimen container ID is information unique to each specimen container 6, and is recorded in the specimen container 6 as described above. The information indicating the type of specimen container 6 included in the specimen container ID may be represented by the same code as the specimen container type, or may be represented by a different code. The status indicates the state of the specimen. The total specimen collection amount is the collection amount of the specimen contained in the specimen container 6. The storage temperature is the temperature at which the specimen is stored. The dispensing amount is the amount of specimen required to perform the test item. The confirmation item is information that needs to be confirmed when performing the test item. The confirmation item content is the content of the confirmed confirmation item. The confirmation items include information that must be confirmed and information that is optional, and either one is specified. The confirmation input URL is a link for inputting the confirmation item.

In one clinical test, one or more test items are performed. In the example shown in FIG. 6, test W, test X, test Y, and test Z are performed, and test W, test X, test Y, and test Z are recorded as test items in association with test request ID "001". The amount of sample required is determined by the test item, the amount of dispensing is determined according to the test item, and the amount of dispensing is recorded in association with the test item. The storage temperature of the sample is determined by the test item, and the storage temperature is recorded in association with the test item. The relationship between the test item and other information such as the amount of dispensing is recorded in advance in a database, and the database is stored in the storage unit 13. The calculation unit 11 reads information related to the determined test item from the database, and records the read information in the sample table 133 in association with the test item.

Depending on the test item, the criteria for determining whether something is abnormal may differ depending on the subject's condition, such as gender, age, or weight. For such test items, it is desirable to check the subject's condition, and the subject's condition, such as gender, age, or weight, is recorded as an optional check item. For some test items, it is mandatory to specify a drug to react with the sample for the test. For such test items, the name of the drug is recorded as a required check item. In the example shown in Figure 6, the contents of the check item have not yet been entered and are left blank.

Samples related to multiple test items that have the same storage temperature can be stored in the same sample container 6. When samples related to multiple test items are stored in one sample container 6, the multiple test items are recorded in association with one sample container type and sample container ID. In the example shown in FIG. 6, test W and test X are associated with the sample container type "sample container A". This means that samples for test W and test X are stored together in one sample container 6 with the sample container type "sample container A". The sum of the dispensed amounts associated with the multiple test items for which samples stored in one sample container 6 are used is the total sample collection amount.

In the example shown in FIG. 6, the sample has not yet been collected, so the status is "not collected." In an uncollected state, the sample container in which the sample will be stored has not yet been determined, so the sample container ID is blank. Similarly, in the sample table 133, information about the sample is recorded in association with each of multiple test request IDs. If the sample is something other than blood, information indicating the type of sample may also be recorded in the sample table 133.

The contents of the specimen table 133 as shown in FIG. 6 are determined by the calculation unit 11 in accordance with the contents of the test request in accordance with the computer program 131. Alternatively, the memory unit 13 may store a guideline table that records guidelines for determining information about specimens in accordance with the contents of the test request, and the calculation unit 11 may determine the contents of the specimen table 133 in accordance with the guideline table. The memory unit 13 that stores the specimen table 133 corresponds to the memory unit of the test support device.

Figure 7 is a flowchart showing an example of the procedure for processing to assist in the collection of a sample executed by the test support system 100. Hereinafter, steps are abbreviated as S. The calculation unit 11 of the storage device 1 executes processing according to the computer program 131, and the calculation unit 21 of the collection support device 2 executes processing according to the computer program 241.

Before the operator 51 collects a sample, the collection support device 2 reads and outputs information related to the collection of the sample from the sample table 133 (S1). In S1, for example, the operator 51 who collects a sample from a subject operates the operation unit 25 while facing the subject to input information for identifying the subject or the test request to the collection support device 2. For example, the subject's name or subject ID, etc. are input as information for identifying the subject. For example, a reception number or test request ID, etc. are input as information for identifying the test request. The information for identifying the subject or the test request may be acquired by the reading unit 27.

The calculation unit 21 transmits information for identifying the subject or the test request from the communication unit 28 to the storage device 1 via the communication network N. The storage device 1 receives the information for identifying the subject or the test request via the communication unit 15. The subject DB 132 records information for identifying the subject, including the subject ID, and information for identifying the test request, such as the test request ID, in association with each other. If the test request ID is unknown, the calculation unit 11 reads out the test request ID associated with the information for identifying the subject or the test request from the subject DB 132. The calculation unit 11 reads out information on the collection of the sample associated with the test request ID from the sample table 133. The calculation unit 11 also reads out the personal information of the subject associated with the test request ID from the subject DB 132. The calculation unit 11 transmits the read information from the communication unit 15 to the collection support device 2 via the communication network N. The collection assistance device 2 receives information via the communication unit 28, and the calculation unit 21 outputs information related to the collection of the sample by displaying a collection assistance image showing information related to the collection of the sample on the display unit 26.

Figure 8 is a schematic diagram showing an example of a collection support image. The collection support image includes the reception date of the test request, the reception number of the test request, the sample collection date, and the subject ID, as well as personal information of the subject, such as name and gender. Furthermore, the collection support image includes the test request ID, and includes the sample container type, sample container ID, and total sample collection amount associated with the test request ID. The calculation unit 21 creates a collection support image according to the information received from the storage device 1, and displays the collection support image on the display unit 26. By displaying the collection support image, information regarding sample collection is displayed.

There is one test request ID per test. If multiple specimen container types are associated with the test request ID, the multiple specimen container types are displayed, and the specimen container ID and total specimen collection amount associated with each specimen container type are displayed. In the example shown in FIG. 8, the specimen container ID has not yet been obtained, and the specimen container ID is blank. In this manner, information regarding specimen collection, including the test request ID and specimen container type, is output. By displaying the specimen container type, the operator 51 can confirm the type of specimen container 6 that should contain the collected specimen.

The collection support device 2 then outputs a request to confirm the subject's personal information (S2). In S2, for example, in response to the operator 51 operating the operation unit 25 to specify a display portion of the subject's personal information on the collection support image by clicking or the like, the calculation unit 21 displays an image representing a request to confirm the personal information on the display unit 26, superimposed on the collection support image.

Figure 9 is a schematic diagram showing an example of an image requesting confirmation of personal information. An image showing the subject's name and gender in text is displayed superimposed on the collection support image. The calculation unit 21 creates an image based on the received personal information of the subject and displays it on the display unit 26. In the example shown in Figure 9, the subject's name and gender are displayed, and confirmation of the name and gender is prompted.

The collection support device 2 then accepts confirmation of the subject's personal information (S3). In S3, for example, the operator 51 confirms the name and sex of the subject himself/herself, and the operator 51 operates the operation unit 25 to input the confirmation of the subject's personal information, and the calculation unit 21 acquires information indicating that the subject's personal information has been confirmed. In the example shown in FIG. 9, the confirmation of the personal information is input by designating a portion of the image that indicates "OK" by clicking or the like. By confirming the subject's personal information, it is confirmed that the person from whom the sample is to be collected is the subject himself/herself for the clinical test. After accepting the confirmation of the personal information, the calculation unit 21 adds a mark indicating that the personal information of the subject included in the collection support image has been confirmed.

In S3, the subject himself/herself, rather than the operator 51, may operate the operation unit 25 to input confirmation of the subject's personal information. If confirmation of the subject's personal information is not accepted, such as when the part indicating "cancel" is specified in the example shown in FIG. 9, the calculation unit 21 may end the process or may resume the process from S1.

In S2 and S3, the collection support device 2 may accept confirmation of personal information other than name and gender. For example, when information indicating that the subject is a person from whom blood collection is difficult and blood collection history are recorded in the subject DB 132 in association with the subject ID, the calculation unit 21 displays an image on the display unit 26 requesting confirmation of the blood collection history and accepts confirmation. For example, the part of the body from which blood was previously collected is displayed as the blood collection history and confirmation is performed. By confirming the blood collection history, points to be aware of when collecting blood are made known, and the difficulty of blood collection is reduced.

The collection support device 2 then outputs an image of the specimen container 6 that is to contain the collected specimen (S4). In S4, the calculation unit 21 displays an image of the specimen container 6, the type of which is indicated by the specimen container type included in the collection support image, superimposed on the collection support image on the display unit 26. For example, image data of the specimen container 6 associated with each specimen container type is pre-stored in the memory unit 13 of the storage device 1, the collection support device 2 reads out the image data from the storage device 1, and the calculation unit 21 creates an image of the specimen container 6 based on the image data and displays it on the display unit 26. The image data may be pre-stored in the memory unit 24 of the collection support device 2.

10 is a schematic diagram showing an example of the display of an image of a specimen container 6. A mark 261 indicating that the name and sex of the subject have been confirmed is added to the name and sex of the subject. In addition, an image of the specimen container 6 is displayed. In the example shown in FIG. 10, three types of specimen container types are associated with the test request ID, and therefore images of the three types of specimen container 6 are displayed. By displaying the image of the specimen container 6, the operator 51 can confirm the appearance of the specimen container 6 that is to contain the collected specimen. Different types of specimen containers 6 have different appearances such as color, size, or shape. In the example shown in FIG. 10, the different types of specimen containers 6 have caps of different colors. By checking the appearance of the specimen container 6, it is possible to effectively prevent the operator 51 from using the wrong type of specimen container 6 and thereby making a mistake in the specimen container 6.

The collection support device 2 then acquires the specimen container ID of the specimen container 6 that is to contain the collected specimen (S5). In S5, the operator 51 selects the specimen container 6 to be actually used, the reading unit 27 reads the specimen container ID from the specimen container 6, and the calculation unit 21 acquires the read specimen container ID. For example, multiple types of specimen containers 6 are prepared at the operator 51's hand, and the operator 51 selects one specimen container 6 that has the same appearance as the specimen container 6 whose image is displayed on the display unit 26. The reading unit 27 reads the specimen container ID recorded in advance on the specimen container 6. For example, the operator 51 brings the reading unit 27 close to the specimen container 6, and the reading unit 27 reads the barcode recorded on the label 61, thereby reading the specimen container ID represented by the barcode. If an RF tag is attached to the specimen container 6, the reading unit 27 reads the specimen container ID recorded on the RF tag using short-range wireless communication.

The collection support device 2 then determines whether the type of specimen container 6 indicated by the acquired specimen container ID matches the type of specimen container 6 indicated by the specimen container type (S6). The specimen container ID includes information indicating the type of specimen container 6. In S6, the calculation unit 21 determines whether the type of specimen container 6 indicated by the information included in the specimen container ID matches the type of specimen container 6 indicated by the specimen container type associated with the test request ID. If the type of specimen container 6 indicated by the acquired specimen container ID does not match the type of specimen container 6 indicated by the specimen container type (S6: NO), the collection support device 2 outputs an error indicating that the types of specimen container 6 are different (S7).

Figure 11 is a schematic diagram showing an example of an error indicating that the type of specimen container 6 is different. In S7, the calculation unit 21 displays a collection support image showing an error as the specimen container ID on the display unit 26. Furthermore, the calculation unit 21 creates an error image including a notification that the specimen container 6 to be used is different and an image of the correct type of specimen container 6, and displays it on the display unit 26 superimposed on the collection support image. It is displayed that the type of specimen container 6 to be used is different, and an image of the correct type of specimen container 6 is displayed. In the example shown in Figure 11, an error and an image are displayed for multiple types of specimen containers 6 for which the specimen container ID has not been obtained. When there is only one type of specimen container 6 for which the specimen container ID has not been obtained, an error and an image are displayed for the one type of specimen container 6.

If the operator 51 selects the wrong type of specimen container 6 and obtains the specimen container ID from the wrong type of specimen container 6, an error is output. This reliably prevents the operator 51 from mixing up the type of specimen container 6 that contains the specimen. In addition, by displaying an image of the correct specimen container 6, the operator 51 can reconfirm the appearance of the correct specimen container 6 to be used.

After S7 is completed, the collection support device 2 returns the process to S5. For example, when the operator 51 operates the operation unit 25 to specify a portion of the image that indicates "cancel," the calculation unit 21 ends the output of the error image and returns the process to S5.

If the type of specimen container 6 indicated by the acquired specimen container ID matches the type of specimen container 6 indicated by the specimen container type (S6: YES), the storage device 1 stores the specimen container ID in association with the test request ID and the specimen container type (S8). In S8, the calculation unit 21 transmits the acquired specimen container ID from the communication unit 28 to the storage device 1. The storage device 1 receives the specimen container ID via the communication unit 15, and the calculation unit 11 stores the specimen container ID in the storage unit 13 by recording the specimen container ID in the specimen table 133 in association with the test request ID and the specimen container type indicating the type matching the type of specimen container 6 indicated by the acquired specimen container ID. By storing the specimen container ID, the specimen contained in the specimen container 6 is associated with the test request ID and the subject ID. It becomes possible to manage specimens based on the specimen container ID.

The collection support device 2 then outputs the specimen container ID in association with the test request ID and the specimen container type (S9). In S9, the calculation unit 21 adds the acquired specimen container ID to the collection support image as the specimen container ID associated with the test request ID and the specimen container type indicating the type that matches the type of specimen container 6 indicated by the acquired specimen container ID, and displays the collection support image with the specimen container ID added on the display unit 26.

Figure 12 is a schematic diagram showing an example of a collection support image after a specimen container ID has been acquired. Figure 12 shows an example in which a specimen container ID has been acquired for a specimen container 6 whose specimen container type is specimen container C. The acquired specimen container ID is displayed in association with the test request ID and the specimen container type indicating specimen container C. By outputting the specimen container ID in association with the specimen container type, the operator 51 can check the specimen container ID and confirm that the type of specimen container 6 from which the specimen container ID has been acquired matches the type of specimen container 6 indicated by the specimen container type. This prevents mix-up of the type of specimen container 6 containing the specimen.

The collection support device 2 then outputs an image of the specimen container 6 to which a mark indicating that the specimen container ID has already been acquired has been added (S10). In S10, the calculation unit 21 adds a mark to the image of the specimen container 6 of the type indicated by the acquired specimen container ID, and displays the image with the mark added on the display unit 26 superimposed on the collection support image. If there is a specimen container 6 for which the specimen container ID has not yet been acquired, the calculation unit 21 also displays an image of the specimen container 6 to which no mark has been added. FIG. 12 shows an example of an image of a specimen container 6 to which a mark 262 indicating that the specimen container ID has already been acquired has been added. Since the specimen container ID of the specimen container 6 whose specimen container type is specimen container C has been acquired, the mark 262 has been added to the image of the specimen container 6 whose specimen container type is specimen container C. By displaying the mark 262, the operator 51 can check the appearance of the specimen container 6 whose specimen container ID has already been acquired. When another specimen container ID is subsequently acquired, the mistake of acquiring a specimen container ID again from a specimen container 6 whose specimen container ID has already been acquired is suppressed.

The collection support device 2 then determines whether there is a check item associated with the test request ID and sample container type related to the acquired sample container ID (S11). In S11, the calculation unit 21 determines whether there is a check item associated with a sample container type indicating a type that matches the type of sample container 6 indicated by the acquired sample container ID in the information related to the sample collection acquired in S1. The calculation unit 21 may access the sample table 133 to determine whether there is a check item associated with the test request ID. If there is no check item (S11: NO), the collection support device 2 proceeds to S16 described below.

If there are confirmation items (S11: YES), the collection support device 2 outputs a collection support image with a mark indicating that there are confirmation items (S12). In S12, the calculation unit 21 adds a mark indicating that there are confirmation items to the collection support image in association with the acquired specimen container ID, and displays the collection support image with the mark added on the display unit 26. FIG. 12 shows an example of a collection support image with a mark 263 indicating that there are confirmation items. The mark 263 is displayed near the specimen container ID. By displaying the mark 263, the operator 51 can know that there are confirmation items.

The collection support device 2 then outputs a confirmation request for the confirmation items (S13). For example, the operator 51 operates the operation unit 25 to specify the mark 264 or the display portion of the specimen container ID or specimen container type on the collection support image, and the calculation unit 21 executes S13 in response to this. In S13, based on the information related to the collection of the specimen, an image representing a confirmation request for the confirmation items associated with the test request ID and specimen container type related to the acquired specimen container ID is displayed on the display unit 26 superimposed on the collection support image. The calculation unit 21 may access the specimen table 133 and output a confirmation request for the confirmation items based on the recorded contents of the specimen table 133.

Figure 13 is a schematic diagram showing an example of an image that displays a confirmation request for a confirmation item. Figure 13 shows an example in which "medication name" is associated as a confirmation item with test request ID "001" and specimen container type "specimen container C". An input image for inputting a specific drug name as the content of the confirmation item is displayed.

The collection support device 2 then accepts confirmation of the contents of the confirmation items (S14). In S14, for example, the operator 51 confirms the contents of the confirmation items, and the operator 51 operates the operation unit 25 to input the contents of the confirmation items, and the calculation unit 21 acquires the contents of the confirmation items. In the example shown in FIG. 13, the name of the drug is input, and the part of the image that shows "OK" is designated, thereby inputting the contents of the confirmation item "drug name". The input of the contents of the confirmation items may be made by selection.

The information regarding the collection of the sample associated with the test request ID includes a designation as to whether confirmation of the confirmation item is mandatory or optional. If the confirmation item is optional, the operator 51 may operate the operation unit 25 to designate a portion of the image that indicates "cancel," and the calculation unit 21 may end S14 without obtaining confirmation of the contents of the confirmation item.

Even if the confirmation item is other than "drug name", the processes of S13 and S14 are performed in the same manner. If multiple test items and multiple confirmation items are associated with one sample container type, the calculation unit 21 may repeat the processes of S13 and S14 multiple times. Alternatively, the calculation unit 21 may output a confirmation request for multiple confirmation items in S13 and obtain the contents of the multiple confirmation items in S14.

The storage device 1 then stores the contents of the confirmation items in association with the test request ID, the specimen container type, and the specimen container ID (S15). In S15, the calculation unit 21 transmits the acquired contents of the confirmation items from the communication unit 28 to the storage device 1 in association with the test request ID, the specimen container type, and the specimen container ID. The storage device 1 receives the contents of the confirmation items through the communication unit 15. The calculation unit 11 stores the contents of the confirmation items in the storage unit 13 by recording the contents of the confirmation items in association with the test request ID, the specimen container type, and the specimen container ID in the specimen table 133. For example, the contents of the confirmation items are recorded using a confirmation input URL. By recording the contents of the confirmation items in the specimen table 133, information necessary for clinical testing is recorded, and appropriate clinical testing is possible using the recorded contents of the confirmation items.

After S15 is completed, or if there are no confirmation items in S11, the collection support device 2 determines whether all specimen container IDs to be acquired have been acquired (S16). In S16, the calculation unit 21 determines whether specimen container IDs have been acquired for all specimen container types associated with the test request ID. The calculation unit 21 may access the specimen table 133 and determine whether specific specimen container IDs are associated with all specimen container types associated with the test request ID.

Figure 14 is a schematic diagram showing an example of a collection support image in a state where all specimen container IDs have been acquired. A specimen container ID is associated with each of the multiple specimen container types, and a mark 262 indicating that the specimen container ID has already been acquired is added to all images of the multiple types of specimen containers 6. The operator 51 can confirm that all specimen container IDs have been acquired.

If there is a specimen container ID that has not been acquired (S16: NO), the collection support device 2 returns the process to S5. If multiple specimen container types are associated with the test request ID, the processes of S5 to S16 are repeated the same number of times as the number of specimen container types. In the second and subsequent processes of S5 to S16, while a specimen container ID has been acquired from one specimen container 6, specimen container IDs are acquired from other specimen containers 6, the specimen container IDs are stored, and the specimen container IDs are output in association with the specimen container types. Even when multiple types of specimen containers 6 are used in a clinical test on one subject, the specimen container IDs of the multiple types of specimen containers 6 are stored, preventing mix-ups of the types of specimen containers 6 that contain specimens.

If all specimen container IDs to be acquired have been acquired (S16: YES), the collection assistance device 2 outputs the collection amount of specimen to be placed in the specimen container 6 (S17). In S17, the calculation unit 21 refers to information regarding specimen collection associated with the test request ID, adds the value of the total specimen collection amount associated with the specimen container type as the specimen collection amount to the image of the specimen container 6 whose type is indicated by the specimen container type, and displays the image of the specimen container 6 with the collection amount added on the display unit 26.

Figure 15 is a schematic diagram showing an example of outputting the collected sample volume. The value of the collected sample volume is added to the image of the sample container 6 for each sample container type. The value of the collected sample volume is the value of the total collected sample volume associated with the sample container type. By outputting the value of the collected sample volume, the operator 51 can confirm the collected sample volume to be stored in each sample container 6.

Then, the operator 51 performs the task of collecting a sample from the subject. For example, the operator 51 draws blood. The operator 51 also places the collected sample in the sample container 6 in which the acquired sample container ID is recorded. After the sample collection is completed, the collection support device 2 accepts that the sample has been collected (S18). In S18, the operator 51 operates the operation unit 25 to input information indicating that the sample collection is completed, and the calculation unit 21 accepts that the sample has been collected.

The storage device 1 then stores that the sample has been collected (S19). In S19, the calculation unit 21 transmits information indicating that the sample has been collected from the communication unit 28 to the storage device 1 in association with the test request ID, the sample container type, and the sample container ID. The storage device 1 receives the information via the communication unit 15. The calculation unit 11 stores in the storage unit 13 that the sample has been collected by recording in the sample table 133 as a status that the sample has been collected, in association with the test request ID, the sample container type, and the sample container ID. By recording in the sample table 133 that the sample has been collected, it is recorded that the sample has been collected and placed in each sample container 6.

Figure 16 is a conceptual diagram showing an example of the contents of the specimen table 133 after a specimen has been collected. The specimen container ID and the contents of the confirmation items are recorded in association with each specimen container type associated with one test request ID, and the status that the specimen has been collected is recorded. The specimen table 133 organizes which specimen containers 6 contain the specimen to be used in the clinical test identified by the test request ID. The specimen table 133 also records, in association with the specimen container ID, which test item of which clinical test the specimen contained in each specimen container 6 is used for. In this way, the specimen table 133 manages information necessary for the clinical test in association with the test request ID and the specimen container ID.

After S19 is completed, the testing support system 100 ends the process for supporting the collection of the sample. The processes of S1 to S19 are executed for each test request ID. Of the processes of S1 to S19, some or all of the processes described above as being executed by the calculation unit 21 of the collection support device 2 may be executed by the calculation unit 11 of the storage device 1. For example, the calculation unit 11 may execute the processes by controlling the operation unit 25 and display unit 26 of the collection support device 2 via the communication network N. The collection support device 2 and the storage device 1 correspond to the testing support device.

The collected samples are sent from the medical institution 20 to the testing institution 30 in a state where each sample is contained in a sample container 6. At the testing institution 30, an operator 52 uses a receiving support device 3 to receive the samples sent from the medical institution 20. The receiving support device 3 is a computer such as a PC, a smartphone, or a tablet computer. The receiving support device 3 includes an operation unit that receives operations from the operator 52, a display unit that displays images, and a reading unit that reads the sample container ID recorded in the sample container 6. The receiving support device 3 acquires the sample container ID from the sample container 6, and checks the information recorded in the sample table 133 in association with the sample container ID.

At the testing institution 30, the samples are managed based on the sample container ID, and clinical tests are performed using the samples according to the information recorded in the sample table 133 in association with the sample container ID. The output device 4 is a computer such as a PC, a smartphone, or a tablet computer. The output device 4 outputs the progress or results of the clinical test. Furthermore, the results of the clinical test are stored in the storage device 1. When there are multiple testing institutions 30, the storage device 1 communicates with the receipt support devices 3 and output devices 4 provided at the multiple testing institutions 30 via the communication network N. The results of the clinical test stored in the storage device 1 are referenced by the medical institution 20 and notified to the subject.

As described above in detail, in this embodiment, the specimen container ID is recorded in advance on the specimen container 6, and the test request ID and specimen container type are recorded in the specimen table 133. The medical institution 20 acquires the specimen container ID from the specimen container 6, and records and outputs the specimen container ID in association with the test request ID and specimen container type. The specimen container ID is recorded in advance on the specimen container 6, and the specimen is managed based on the specimen container ID acquired from the specimen container 6. The medical institution 20 does not need to perform work to assign the specimen container ID to the specimen container 6, such as creating a label 61 on which the specimen container ID is recorded and attaching it to the specimen container 6. This reduces the work associated with collecting specimens at the medical institution 20.

The specimen container ID includes information indicating the type of specimen container 6. By outputting the acquired specimen container ID and specimen container type, the operator 51 can confirm that the type of specimen container 6 from which the specimen container ID was acquired matches the type of specimen container 6 indicated by the specimen container type. This prevents mix-up of the type of specimen container 6 containing the specimen.

In addition, in this embodiment, samples are managed using the sample container ID that is pre-recorded in the sample container 6, so there is no need to build a system for handling sample container IDs independently for each medical institution 20. This reduces the cost of the system required for clinical testing.

In this embodiment, the operator 51 selects the specimen container 6 in which the specimen should be stored, but the test support system 100 may also be configured to separate the necessary specimen containers 6 in response to a test request. FIG. 17 is a block diagram showing another example of the internal functional configuration of the collection support device 2. The collection support device 2 is a picking unit 29 that picks out a specific type of specimen container 6 from a storage facility in which multiple types of specimen containers 6 are stored. For example, the picking unit 29 is configured using a dispenser or a robot arm.

Figure 18 is a flowchart showing an example of the procedure of the process of dividing the specimen containers 6. The collection support device 2 executes the process in a state where a test request is created and information related to the collection of specimens is recorded in the specimen table 133 in association with the test request ID. The collection support device 2 reads information related to the collection of specimens associated with one test request ID from the specimen table 133 (S21). In S21, the test request ID is input from the operation unit 25. The calculation unit 21 reads information related to the test request ID from the specimen table 133 via the communication network N. The collection support device 2 then specifies the type and number of specimen containers 6 to be used based on the information related to the collection of specimens associated with the test request ID (S22). In S21, the calculation unit 21 specifies the type of specimen container 6 from the specimen container type associated with the test request ID. In addition, the calculation unit 21 specifies the number of specimen containers 6 of each type from the number of each specimen container type associated with the test request ID.

The collection support device 2 then separates the specified type and number of specimen containers 6 (S23). In S23, the calculation unit 21 causes the picking unit 29 to remove the specified type and number of specimen containers 6. The picking unit 29 may perform a process of placing the removed specimen containers 6 in a specific position. Alternatively, the picking unit 29 may perform a process of packing the removed specimen containers 6 together. After S23 is completed, the collection support device 2 ends the process of separating the specimen containers 6. The collection support device 2 may display the type and number of specimen containers 6 to be separated on the display unit 26 without using the picking unit 29, and perform a process of having the operator 51 separate the specimen containers 6. The process of separating the specimen containers 6 may be performed using an information processing device (not shown) other than the collection support device 2.

The processes of S21 to S23 are performed before the processes of S1 to S19. The processes of S21 to S23 may be performed for each of a plurality of test request IDs. By performing the process of separating the sample containers 6, the necessary sample containers 6 are separated before the sample is collected. The operator 51 can use the separated sample containers 6 when collecting the sample. This prevents the type of sample container 6 from being mixed up when collecting the sample.

The present invention is not limited to the contents of the above-described embodiment, and various modifications are possible within the scope of the claims. In other words, embodiments obtained by combining technical means that are appropriately modified within the scope of the claims are also included in the technical scope of the present invention.

REFERENCE SIGNS LIST 100 Test support system 1 Storage device 10 Recording medium 131 Computer program 133 Sample table 201 Input device 2 Collection support device 200 Recording medium 241 Computer program 27 Reading unit 3 Receiving support device 4 Output device 51, 52 Operator 6 Sample container 61 Label N Communication network

Claims (11)

A method for assisting a clinical test using a sample collected from a subject by a computer , comprising:
A specimen container for containing a specimen is recorded in advance with container type information indicating the type of the specimen container and container identification information that is unique to the specimen container and that identifies the specimen container,
storing test identification information for identifying a clinical test and container type information of a specimen container for containing a specimen required for the clinical test in a computer in association with each other;
outputting the test identification information and the container type information by a computer before collecting a specimen;
Before collecting the specimen, container identification information is obtained from the specimen container by a computer ;
The acquired container identification information is output by a computer in association with the inspection identification information and the container type information ;
storing confirmation items that require confirmation regarding the clinical test in association with the test identification information and the container type information in a computer;
When the container identification information is acquired, a request for confirmation of the contents of the confirmation items associated with the test identification information and the container type information is output by a computer;
The contents of the confirmation items are acquired by a computer;
The contents of the confirmation items are stored in a computer in association with the test identification information and the container type information.
13. An inspection support method comprising: storing a plurality of container type information items in association with the test identification information in a computer ;
In a state where one container identification information has already been acquired from one specimen container, another container identification information recorded on another specimen container of a different type from the one specimen container is acquired by a computer ;
The inspection support method according to claim 1, characterized in that the acquired other container identification information is output by a computer together with the one container identification information in association with inspection identification information and container type information related to the other container identification information. 3. The inspection support method according to claim 1, further comprising storing the acquired container identification information in a computer in association with the inspection identification information and the container type information. A computer determines whether or not the type of specimen container indicated by the acquired container identification information matches the type of specimen container indicated by the container type information associated with the test identification information;
outputting an error by a computer when the type of specimen container indicated by the acquired container identification information does not match the type of specimen container indicated by the container type information;
A test support method according to any one of claims 1 to 3, characterized in that when the type of sample container indicated by the acquired container identification information matches the type of sample container indicated by the container type information, the acquired container identification information is output by a computer in association with the test identification information and the container type information. storing personal information of the subject in a computer in association with the test identification information and the container type information;
outputting, by a computer , a request for confirmation of personal information associated with the test identification information and the container type information before collecting a specimen;
5. The method according to claim 1 , further comprising the step of acquiring information indicating that the personal information has been confirmed by a computer . 6. The test support method according to claim 1 , further comprising: outputting, by a computer, an image of a specimen container, the type of which is indicated by the container type information, before the specimen is collected. storing in a computer a sample amount to be contained in a sample container whose type is indicated by the container type information, in association with the test identification information and the container type information;
The test support method according to claim 6 , further comprising: outputting, by a computer , a collection amount associated with the test identification information and the container type information in association with the image of the sample container. The inspection support method according to claim 6 or 7, characterized in that, when container identification information is acquired, an image of a sample container whose type is indicated by the acquired container identification information is added with a mark indicating that the container identification information has already been acquired, and the image of the sample container is output by a computer . Identifying the type and number of specimen containers to be used by a computer based on container type information stored in association with the test identification information;
9. The method according to claim 1, further comprising the step of: sorting out the specified type and number of sample containers by a computer . An apparatus for supporting work for clinical testing using a sample collected from a subject, comprising:
A calculation unit;
a storage unit that stores test identification information for identifying a clinical test and container type information indicating a type of a specimen container for containing a specimen required for the clinical test in association with each other;
an output unit that outputs the test identification information and the container type information;
an acquiring unit that acquires, from a specimen container, container identification information that is recorded in advance in the specimen container and includes container type information of the specimen container and information that is unique to the specimen container and is used to identify the specimen container;
The output unit outputs the acquired container identification information in association with the test identification information and the container type information,
the storage unit stores confirmation items that require confirmation regarding the clinical test in association with the test identification information and the container type information;
the output unit outputs a request for confirmation of contents of a confirmation item associated with the test identification information and the container type information when the acquisition unit acquires the container identification information;
The calculation unit acquires the contents of the confirmation items,
The storage unit stores the contents of the confirmation items in association with the test identification information and the container type information.
2. An inspection support device comprising: outputting test identification information for identifying the clinical test and container type information indicating the type of specimen container for containing the specimen required for the clinical test;
Acquire container identification information that is recorded in advance in the sample container and includes container type information of the sample container and information that is unique to the sample container and is used to identify the sample container;
outputting the acquired container identification information in association with the inspection identification information and the container type information;
The test identification information and the container type information are associated with confirmation items that require confirmation regarding a clinical test, and when the container identification information is acquired, a request to confirm the contents of the confirmation items associated with the test identification information and the container type information is output;
Obtain the contents of the confirmation items,
The contents of the confirmation items are stored in association with the test identification information and the container type information.
A computer program that causes a computer to execute a process.