JP4951595B2 - Clinical examination information processing apparatus, system, analysis apparatus, and program thereof - Google Patents

Description

The present invention is a clinical test information processing apparatus, system and analyzer, and to their program. More specifically, clinical testing information processing apparatus to report to the doctor, etc. The analytical results of the analyzed patient samples by analyzer approved, the system and the analyzer, and to their program.

Conventionally, in the examination of specimens such as blood and urine of a patient, an examination engineer confirms the examination result obtained by the analyzer and approves the examination result if the examination result satisfies a predetermined condition. To report to a doctor.
As a clinical test system capable of approving such test results, for example, a clinical test system described in Patent Document 1 is known. According to this clinical test system, a flag is input to a test result that has been approved by a laboratory technician, and a doctor can refer to only the test result for which the flag has been input. Therefore, it is possible to prevent a doctor from referring to an unapproved test result.

  On the other hand, in order to accurately measure a patient sample with the above-described analyzer, it is necessary to use the analyzer in a state in which the performance according to the specifications specified by the manufacturer is exhibited. If the quality control material prepared in such a way is measured and the measurement result deviates beyond a certain range (normal range) from the target value, the quality control that determines that some abnormality has occurred in the analyzer Generally done. If the measurement result of the quality control substance is out of the normal range, the result obtained by measuring the patient sample using such an analyzer is low in reliability and may be reported to the doctor. Can not.

Japanese Patent Laid-Open No. 2001-155093

  However, in the conventional clinical laboratory system, the accuracy management data of the analyzer and the measurement result of the patient specimen are managed separately, and a plurality of laboratory technicians are involved in the system in addition to the person who performed the accuracy management. In many cases, in order to perform reliable accuracy control and report only reliable measurement results to a doctor, a lot of time-consuming confirmation work is required.

The present invention has been made in view of such circumstances, and only the measurement result of the analyzer for which the quality control result has been approved is subject to approval, so that the unreliable test result is reported to the doctor. clinical examination information processing apparatus capable of preventing the put away of reliably, and its object is to provide a system and analyzer, and their programs.

The clinical test information processing apparatus of the present invention is communicably connected to a sample analyzer via a network, and clinical test information for performing an approval process of a sample analysis result obtained by analyzing the sample by the sample analyzer A processing device, a storage unit for storing a sample analysis result received from the sample analyzer and an analysis result of the sample for quality control received from the sample analyzer, a display unit, and a quality control process of displaying the analysis input can be quality control analysis of the results of the authorization approval screen on the display unit, the quality control in the storage unit via a quality control sample analysis results approval screen to enter a quality control analysis of the results approved made process of storing that analytical results are approved, quality control analysis results are displayed information indicating whether it is authorized, and, capable specimen was input sample analysis results approved Result processing of displaying a confirmation screen, and quality control analysis results have been approved, and, if the input of the sample analysis results approved is issued through the sample analysis results approval screen displayed on the display unit to a control unit for executing a process to approve the test body analysis, comprising a control unit, when the input of the sample analysis results approved through the sample analysis results approval screen displayed on the display unit is made However, if the quality control analysis result is not approved, the sample analysis result is not approved, or the sample analysis result received from the sample analyzer or the quality control sample received from the sample analyzer a storage unit for storing a predetermined condition for approving quality control analysis results and sample analysis results analysis is the result, the display unit and, quality control analysis capable input of the quality control analysis approval Processing of displaying appears asking the display unit, and stores that quality control analysis result is approved and the storage unit via a quality control sample analysis results approval screen is input in the quality control analysis results approved made process, And a control unit for executing a process of automatically approving the sample analysis result when the quality control analysis result is approved and the sample analysis result matches the predetermined condition, The control unit is characterized in that even if the sample analysis result matches the predetermined condition, the sample analysis result is not approved unless the quality control analysis result is approved.

Doctors Contact name herein includes, but is used term "approval" for both analysis and quality control results, the result of analysis of the sample by the analyzer to "authorization" is a analysis result laboratory technician In addition, “approved” for the quality control result means that the analyzer can perform as specified as a result of measuring the sample for quality control. It means to admit.

The clinical test information processing system of the present invention is connected to a sample analyzer capable of outputting a sample analysis result to the outside, and the sample analyzer to communicate with the sample analyzer via a network, and the sample analyzer analyzes the sample. A clinical test information processing system comprising: a clinical test information processing apparatus for performing an approval process for a sample analysis result obtained in this manner, wherein the clinical test information processing apparatus receives the sample analysis result and the sample analysis received from the sample analyzer display and storage unit for storing the quality control analysis result is an analysis result of the quality control sample received from the device, and a display unit, a quality control analysis result confirmation screen that can enter the approval of the quality control analysis unit displayed on the processing, storing that quality control sample analysis result confirmation screen quality control analysis result storage unit input approval of the quality control analysis is performed through is approved Processing of, quality control analysis results are displayed information indicating whether it is authorized, and the process of displaying a capable sample analysis result confirmation screen input of the sample analysis results approved, and, quality control analysis has been approved, and a control for executing a process to approve the test body analysis results when the input of the sample analysis results approved through the sample analysis results are displayed on the display unit approval screen is made comprising a part, a control part, if not also approved quality control analysis results in a case where the input of the approval of the sample analysis results are displayed on the display unit approval screen through the sample analysis results is made specimens The quality control is characterized in that the analysis result is not approved, or the clinical laboratory information processing device is the sample analysis result received from the sample analyzer, or the analysis result of the quality control sample received from the sample analyzer Displaying a storage unit for storing a predetermined condition for approving analysis results and sample analysis results, a display unit, the display unit capable of quality control analysis result confirmation screen input approval of the quality control analysis process, authorization process of storing that quality control sample analysis result confirmation screen quality control analysis result storage unit input approval of the quality control analysis is performed through is approved, and, quality control analysis results And a control unit for executing a process of automatically approving the sample analysis result when the sample analysis result matches the predetermined condition, and the control unit Even if the predetermined condition is met, the sample analysis result is not approved unless the quality control analysis result is approved.

The analyzer of the present invention is obtained by analyzing a sample and obtaining a sample analysis result, and by analyzing a sample for quality control using the sample analysis result obtained by analyzing the sample by the analyzing unit and the analyzing unit. and was quality control analysis result storage unit for storing, display section and a process of displaying on the display unit is capable of quality control analysis result confirmation screen input of the quality control analysis results approved quality control sample analysis results approved process of storing that quality control analysis result is approved and the storage unit through the screen input approval of the quality control analysis is made, information is displayed indicating whether the quality control analysis results are approved It is, and the process of displaying a capable sample analysis result confirmation screen input of the sample analysis results approved, and, quality control analysis results have been approved, and, sample analysis results displayed on the display unit Accepted And a control unit for executing a process to approve the test body analysis results when the input of the sample analysis results through the screen approval is made, the control unit, the sample analysis results approved displayed on the display unit or characterized in that it does not approve the sample analysis result when the input is made at a also quality control analysis if has not been approved sample analysis results approved through the screen, or by analyzing the analyte sample To approve the analysis means for obtaining the analysis results, the sample analysis results obtained by analyzing the samples by the analysis means, the quality control analysis results obtained by analyzing the quality control samples by the analysis means, and the sample analysis results through a storage unit for storing a predetermined condition, a display unit, processing of displaying a capable quality control analysis result confirmation screen input approval of the quality control analysis results, the quality control sample analysis result confirmation screen Fine Process of storing that quality control analysis results are approved storage unit inputs the approval management analysis is made, and the accuracy management analysis has been approved, and, sample analysis result of the predetermined A control unit for executing a process of automatically approving the sample analysis result when the condition is met, and the control unit is accurate even when the sample analysis result meets the predetermined condition. If the management analysis result is not approved, the sample analysis result is not approved.

In addition, the program for clinical laboratory information processing according to the present invention includes a sample analysis result received from a sample analyzer and a sample analyzer to perform an approval process for a sample analysis result obtained by analyzing the sample by the sample analyzer. Quality control analysis result approval screen that allows the input of approval of quality control analysis results to a computer equipped with a storage unit for storing the quality control analysis results that are analysis results of the received quality control samples and a display unit a process of displaying on the display unit and a process of storing that quality control analysis results are approved storage unit Ru is made to enter the approval of the quality control analysis results through the quality control sample analysis result confirmation screen, quality control analysis results are displayed information indicating whether it is authorized, and the process of displaying a capable sample analysis result confirmation screen input of the sample analysis results approved, precision tube Analysis has been approved, and, is executed and a process to approve test body analysis results when the input of the sample analysis results through the sample analysis results approval screen displayed on the display unit approval is made, it does not perform the process to approve the sample analysis results if not also approved quality control analysis results in a case where the input of the sample analysis results approved is issued through the sample analysis results are displayed on the display unit approval screen Or sample analysis results received from the sample analyzer and sample for quality control received from the sample analyzer in order to approve the sample analysis result obtained by analyzing the sample by the sample analyzer. Approval of quality control analysis results in a computer having a storage unit for storing predetermined conditions for approving the quality control analysis results and sample analysis results that are analysis results of the above and a display unit Approval processing for displaying the input can be quality control analysis result confirmation screen on the display unit, the quality control analysis results and the storage unit via a quality control sample analysis result confirmation screen Ru made to enter the approval of the quality control analysis results And processing for automatically approving the sample analysis result when the quality control analysis result is approved and the sample analysis result meets the predetermined condition. Even if the sample analysis result matches the predetermined condition, if the quality control analysis result is not approved, the process for approving the sample analysis result is not executed.

Clinical examination information processing apparatus of the present invention, systems and analyzers, and according to the programs, by only measurement results of the analyzer the quality control results were approved and approval subject, unreliable test results Can be reliably prevented from being reported to the doctor.

DESCRIPTION OF THE PREFERRED EMBODIMENTS Embodiments of a clinical test information processing apparatus, method, system and analysis apparatus, and their programs according to the present invention will be described below in detail with reference to the accompanying drawings.
FIG. 1 is a diagram showing a configuration of a clinical test information processing system (hereinafter also simply referred to as a system) according to an embodiment of the present invention. The system according to the present embodiment analyzes a sample such as blood or urine of a patient, and outputs the analysis results 10, 20, and 30 indicating the results to the outside, and the analysis results are received and processed. The computer includes a server computer 1 that is a clinical test information processing apparatus and a user computer 3 that is connected to the server computer 1 and that performs operations such as approval of analysis results by a laboratory technician. In this embodiment, three client computers 2 which are terminals that can refer to the analysis result are provided in the hospital, and these client computers 2 are connected to the server computer 1 via the hospital host computer 4. Yes. The server computer 1 is connected to a printer 5 that is an output means for outputting analysis results of patient samples. The server computer 1, the user computer 3, and the printer 5 constitute a LIS (Laboratory Information System), and the hospital host computer 4 and the client computer 2 constitute a HIS (Hospital Information System). The server computer 1 and the in-hospital host computer 4, the in-hospital host computer 4 and the client computer 2, and the server computer 1 and the user computer 3 are connected by a network such as a LAN. In this specification, the laboratory technicians who perform analysis and approval of specimens are referred to as “users”. Doctors, nurses, patients, etc. on the side requesting examinations and referring to and using the obtained examination results Is called “client”. In the present specification, “sample” refers to a sample for analysis provided from a human or animal, such as a patient or a subject for health examination, except for the case of “quality control sample” or “QC sample”.

The analyzer 10 is a blood cell counter and includes an analyzer main body 11 and a computer 12, and the analyzer 20 is a blood coagulation measuring device and includes an analyzer main body 21 and a computer 22. Reference numeral 30 denotes a biochemical measuring apparatus, which includes an analyzer main body 31 and a computer 32. The analyzer main body 11 includes a sample aspirating unit for taking a patient's blood as a sample into the device, a sample preparing unit for preparing a sample for detection (measurement) from the sample, and optical information from the sample. Based on the information obtained by the detection unit while controlling the operation of the detection unit for detecting electrical information, a communication interface for communicating with the outside of the apparatus main body, the sample aspiration unit, the sample preparation unit, and the detection unit And a general configuration of this type of blood cell counter comprising a control unit for counting blood cells (see FIG. 15). Although not shown, the analyzer main body 21 and the analyzer main body 31 also have a general configuration as with the analyzer main body 11.

The user computer 3 is operated by a laboratory technician, while the client computer 2 is generally operated by an attending physician. Depending on the type of information, a doctor, nurse or patient himself / herself operates the client computer 2 depending on the type of information. Then, the analysis result or the like may be referred to.

As shown in FIG. 2, the server computer 1 mainly includes a computer main body 40, an input unit 41, and a display unit 42. The computer main body 40 includes a ROM 43, a RAM 44, and a hard disk 45, which are storage means. The CPU 46 is a processing means for performing processing such as calculation and determination, and various interfaces, that is, an input / output interface 47, an image output interface 48, and a communication interface 49 are provided. And this server computer 1 is based on the quality control result information acquired by the acquisition means which acquires the quality control result information which shows the result of the quality control of the analyzer which analyzes a sample in this invention, and this acquisition means, Sample approval means for approving the analysis result when the analyzer analyzes the sample, and further approval of the analysis result when the analyzer analyzes the sample based on the quality control result information acquired by the acquisition means It is configured to function as an approval permitting means for determining whether or not to accept.

In the hard disk 45, as shown in FIG. 3, various databases (hereinafter also referred to as DB) and programs are stored. Specifically, a QC result DB that stores results of quality control (hereinafter also referred to simply as QC), a patient sample result DB that stores analysis results of patient samples, and an analysis result of quality control samples Target value DB in which the target value or target value is stored, measurement item normal range DB indicating the normal range for each measurement item of the patient sample, communication program, QC result manual approval program, patient sample result manual approval program 1 The patient sample result manual approval program 2, the patient sample result automatic approval program 1, the patient sample result automatic approval program 2, and the report program are stored. These DBs and programs will be described in detail later.

In the present embodiment, various programs are prepared so that both the approval of the analysis result and the approval of the quality control result can be performed either manually or automatically as desired. Manual or automatic switching may be performed by an appropriate switch means (not shown) provided in the server computer 1 or may be performed by operating the input unit 41. It is not limited.

Next, a method for processing clinical test information in the system according to the present embodiment will be described.
As described above, in the present embodiment, both the approval of the analysis result and the approval of the quality control result can be performed either manually or automatically as desired. Specifically, the following four types are configured. A desired mode can be selected from the modes.

[1] Mode 1
In mode 1, both QC result approval and patient sample result approval are performed manually. A QC result manual approval program is used for QC result approval, and a patient sample result manual approval program 1 is used for patient sample result approval.

(1) Data communication from the analyzer Although common to all modes, the analysis results (including both patient samples and quality control samples) in the analyzers 10, 20, and 30 are transmitted to the server computer 1. And stored in a predetermined database of the server computer 1. FIG. 4 is a flowchart showing a procedure of processing by a communication program for receiving such data (installed in the server computer 1. The same applies to other programs described later).

First, when the server computer 1 receives data from the analyzers 10, 20, and 30 (step S10), the server computer 1 determines whether or not the data is an inquiry about the requested content (analysis item). Judgment is made (step S11). The data transmitted from the analyzers 10, 20, and 30 are usually two types of inquiries about request contents and analysis results, but the server computer 1 first asks what the data should be analyzed. It is determined whether or not the query is from the analyzer.

If it is an inquiry about the requested content (analysis item), the requested content (analysis item) is returned to the analysis device 10, 20, 30 (step S12), and if not, the data Is a sample analysis result (step S13). If the data is the analysis result of the sample, it is further determined whether the data is the analysis result of the QC sample or the analysis result of the patient sample (step S14). If it is determined that the result is the analysis result of the QC sample, the data is stored in the QC result DB (step S15). If it is determined that the result is the analysis result of the patient sample, the data is stored in the patient sample result DB. Stored (step S16). Table 2 shows an example of the contents of the QC result DB, and Table 3 shows an example of the contents of the patient sample result DB. In Table 2, “QC sample ID” is an identification number of a QC sample, and in Table 3, “patient ID” is a patient identification number. The format of such a database can be changed as appropriate according to the type of analysis apparatus, analysis items, and the like.

(2) Approval of QC result A QC result manual approval program is used for approval of the QC result. FIG. 5 is a flowchart showing a procedure of processing by the QC result manual approval program.
This program can be set to start, for example, when an inspection engineer (user) opens the screen of his terminal device (user computer 3). When the screen is started, a QC result approval screen is first displayed on the terminal device. It is displayed on the display unit (step S20). Then, when the inspection engineer inputs an analyzer ID for identifying the analyzer to which the QC result should be approved (step S21), the QC result (unapproved) of the designated analyzer is acquired from the QC result DB ( Step S22). The laboratory technician confirms the QC result obtained from the QC result DB and displayed on the QC result approval screen, determines whether or not this is a value that may be approved, and the value that may be approved If it is, the approval button is pressed (step S23). FIG. 8 shows an example of such a QC result approval screen. The QC result is approved by clicking an “approval” button 63 at the lower right in the figure. In the example of FIG. 8, the QC results are approved for two items (WBC and RBC), and an “x” mark is displayed in the check box 62 to be approved.

Approval of the QC sample includes a case where all items measured by one QC sample are approved together and a case where each item is approved for each item. For example, in the blood cell counter which is the target of quality control in the example shown in FIG. 8, it is normal to measure all measurement items such as WBC and RBC and report all measurement items at once. WBC and RBC are approved together. Therefore, in this example, when the QC result approval screen is displayed, “x” marks are displayed by default in the two check boxes. When the “approval” button 63 is clicked, WBC and RBC are collectively approved. On the other hand, two types of QC samples are used in an analyzer for performing a biochemical test, and the items of NA (sodium), K (potassium), and CL (crawl) are handled in one of the QC samples. An item called NAG (acetylglucosaminidase) may be handled in a sample for QC. In this case, as shown in FIG. 10, the above four items are displayed simultaneously on the QC result approval screen. However, if the NAG result is far from the target value, the laboratory technician will approve the NAG result. Only the QC results of NA, K, and CL are approved. This individual approval can be performed by, for example, specifying (clicking) the check box 62 of an item to be approved and then clicking the “approval” button 63.

When the approval button is pressed, the approval flag of the QC result DB is updated to an approved state (step S24). In the example shown in Table 2, “1” represents approved and “0” represents unapproved. When the update of the approval flag of the QC result DB is completed, an inquiry is made as to whether or not to approve the QC result of another analyzer (step S25). If the approval is continued, the process returns to step S22, and the other The ID of the analyzer is input and the procedure described above is repeated.

Whether or not to approve the QC result is determined based on whether or not the QC result is out of a certain range (normal range) including the target value or target value of the QC sample. For example, it can be determined based on whether or not the QC result to be approved is within the range of the target value ± 2SD. The SD value is calculated every time the QC sample is analyzed in consideration of all the results measured with the QC sample in the same lot in the analyzer for accuracy control. The SD value is a value obtained by dividing the sum of the squares of the difference between the average value of all measurement values and each measurement value by the number of measurement data and taking the square root. It should be noted that the approval criteria can be within the range of the target value ± SD, which is a stricter standard, for example, besides the range of the target value ± 2SD.

(3) Approval of patient sample result The patient sample result manual approval program 1 is used for the approval of the patient sample result. FIG. 6 is a flowchart showing a procedure of processing by the patient sample result manual approval program 1.
This program stores, for example, a fixed number of unapproved patient sample results in the patient sample result DB at regular time intervals or at predetermined times (for example, 10 am, 2 pm and 4 pm). It can be set to start every time. When the program is started, a screen for searching for patients and examination results is displayed (step S30). Next, when a search condition is input (step S31), the search is executed (step S32). The search can be performed according to appropriate conditions. For example, the patient ID or the urgency level of approval (in this case, the urgency level needs to be set as an attribute of the patient sample result) can be used as the search condition.

When the search is executed, a patient sample result approval screen including information indicating whether or not the patient ID, patient sample result and QC result are approved is displayed on the display unit of the laboratory technician's terminal device (user computer 3). It is displayed (step S33). If there are multiple approval targets, the first approval target screen is displayed. At this time, the normal range of the measurement item to be approved can be displayed on the approval screen. Since the normal range varies depending on age, sex, etc., the corresponding items are extracted from the measurement item normal range DB stored in the hard disk 45 of the server computer 1 and displayed. Also, other information such as a graph of the past measurement results of the patient can be displayed.

FIG. 9 is a diagram illustrating an example of a patient sample result approval screen, and FIG. 11 is a diagram illustrating another example of the patient sample result approval screen. The screen shown in FIG. 9 is a simplified example for explanation, and the screen shown in FIG. 11 is an example in which additional information such as the normal range of the measurement item described above is displayed. In FIG. 9, a check box 61 indicates whether or not the QC result is approved. “2” indicates approval, and “1” indicates non-approval. The check box 62 is a box for approving the patient sample result, where “x” indicates approval and no mark indicates unapproved. The approval of the patient sample result can be performed by selecting (clicking) the check box of the corresponding measurement item and then pressing (clicking) the approval button 63.

In FIG. 11, reference numerals 70 and 71 denote a sample number and a patient identification number, respectively. Test results and the like are displayed in a tabular form on the left side of the screen, and image data sent from the analyzer along with the test results are displayed on the right side of the screen.
The table includes, from the left end, the QC result approval status column 72, the patient sample result approval status column 73, the test item column 74, the test result column 75, the upper and lower limit mark column 76, the comment column 77 for the test result, An inspection status display column 78, a unit column 79, and a reference value column 80. In the approval status column 72 of the QC result, “Y” indicates approval (“N” is not approved, and blank is not measured). In the approval status column 73 of the patient sample result, “1” indicates measurement and non-approval (“0” indicates no measurement, and “2” indicates approval). The upper and lower limit marks indicate how far the inspection result deviates from the reference value, and are displayed as “L”, “l”, “h”, or “H”. “H” indicates that the inspection result is slightly larger than the reference value, “H” indicates that the inspection result is considerably larger than the reference value, and “l” indicates that the inspection result is slightly smaller than the reference value. “L” indicates that the inspection result is considerably smaller than the reference value. In this example, the patient sample result can be approved by clicking the corresponding measurement item in the approval status column 73 of the patient sample result and then clicking the “Validation” button 81 (approval button) at the lower right of the screen. .

Note that the screen shown in FIG. 11 is merely an example, and other items (for example, examination results other than the approval target items of the same patient) can be displayed, or other display formats can be adopted.
By displaying information related to the approval of quality control results on the screen for approving the analysis results, an inspection engineer who wants to approve the analysis results checks whether the quality control results of the analyzer are approved. The analysis results can be approved. In other words, the inspection engineer can approve the analysis result while grasping the accuracy management status of the analyzer (whether or not the analyzer can function according to the manufacturer's specifications).

The inspection engineer confirms the approval status of the displayed QC result, determines whether or not this can be approved, and presses the approval button if it can be approved (step) S34).
Next, it is determined whether or not the QC result of the analyzer that has analyzed the patient sample is approved (step S35). Specifically, it is determined whether or not the approval flag is “1” in the QC result DB. When it is determined that the QC result is approved, the patient sample result is approved for the first time, and the result is reflected in the patient sample result DB (step S36). Specifically, the approval level representing the approval state is updated to a predetermined value. For example, when three levels of “0” (unmeasured), “1” (unapproved), and “2” (approved) are set as approval levels, this approval level can be updated to “2”. . It is possible to set multiple levels of approval even for the same approval. For example, together with a general inspection engineer, if a high-level inspection engineer who has more experience than this inspection engineer and is proficient in the inspection approves the analysis results, the approval by the general inspection engineer is set to approval level 2, By setting the approval by the laboratory technician to approval level 3, information on the reliability of the approval can be provided to a doctor or the like.

On the other hand, if the QC result is not approved, an error message is displayed (step S37). The error message may be, for example, a content such as “QC result is unapproved. Please approve the QC result.” By displaying the error message, the laboratory technician can easily and reliably confirm that the accuracy control result of the analyzer is not approved, that is, the analyzer is in a state where some trouble has occurred and the predetermined accuracy cannot be obtained. Can grasp. Thereby, the inspection and repair of the analyzer in which the defect is found can be performed at an early stage.

Next, it is determined whether or not all the search results have been approved (step S38). If “No”, the process proceeds to approval of the next request (step S39). If “Yes”, the patient sample result is approved. The process ends.
In the present embodiment, the server computer 1 accepts the approval of the QC result and the patient sample by causing the user computer 3 to display an approval screen, but displays these approval screens on the display unit 43. Approval may be accepted.

(4) Reporting patient specimen results Common to all modes, but approved patient specimen results are reported to the attending physician. FIG. 7 is a flowchart showing a processing procedure by a report program for reporting such a patient sample result.

This program can be set to start, for example, when a laboratory technician opens a report screen, or automatically at regular intervals. When the laboratory technician inputs report conditions such as patient ID and report destination (step S40), patient sample results that match the report conditions are extracted from the patient sample result DB (step S41). Next, only the approved patient sample result is further extracted from the extracted patient sample result (step S42). This “approved” means that both the QC result and the patient sample result have been approved as described above.

The extracted approved patient sample result is output (in-hospital host computer or printer) to the input report destination (step S43). Next, an inquiry is made as to whether or not to continue reporting under other conditions (step S44). If “Yes”, the process returns to step S40 to input the reporting conditions. If “No”, the reporting process ends. .
According to the report program, only the approved analysis result among the analysis results is output, so that only the measurement result obtained by the highly reliable analyzer in which the quality control result is approved can be obtained.

[2] Mode 2
In mode 2, QC result approval is automatically performed, and patient sample result approval is manually performed. The patient sample result manual approval program 2 is used for the patient sample result approval (the step of automatically approving the QC result is incorporated in the patient sample result manual approval program 2). In mode 2 and modes 3 to 4 to be described later, the procedures for data communication from the analyzer and reporting of patient sample results are the same as in mode 1, and therefore description thereof is omitted.

(1) Approval of patient sample result The patient sample result manual approval program 2 is used for approval of the patient sample result. FIG. 12 is a flowchart showing a procedure of processing by the patient sample result manual approval program 2.
When the program is started, a screen for searching for patients and examination results is displayed (step S50). Next, when a search condition is input (step S51), the search is executed (step S52). The search can be performed according to appropriate conditions. For example, the patient ID or the urgency level of approval (in this case, the urgency level needs to be set as an attribute of the patient sample result) can be used as the search condition.

When the search is executed, a patient sample result approval screen including display of the patient ID, patient sample result, QC sample result, and normal range of the QC sample result is displayed on the display unit of the terminal device of the laboratory technician (user) ( Step S53). If there are multiple approval targets, the first approval target screen is displayed. At this time, the normal range of the measurement item to be approved can be displayed on the approval screen. Since the normal range varies depending on age, sex, etc., the corresponding items are extracted from the measurement item normal range DB stored in the hard disk 45 of the server computer 1 and displayed. It is also possible to display a graph of past measurement results of the patient. The laboratory technician checks the displayed QC sample result, determines whether or not this can be approved, and presses the approval button if it can be approved (step S54). .

Next, it is determined whether or not the QC result of the analyzer that has analyzed the patient sample is within a normal range (step S55). Specifically, it can be determined whether the QC result is within the normal range according to the above-described determination criteria (whether the target value is within the range of ± 2SD). Note that this determination criterion (whether or not it is within the range of the target value ± 2SD) is merely an example, and other determination criteria can be adopted as appropriate.

When it is determined that the QC result is within the normal range, the patient sample result is approved for the first time, and the result is reflected in the patient sample result DB (step S56). Specifically, as described in mode 1, the approval level representing the approval state is updated to a predetermined value. On the other hand, if the QC result is not approved, an error message is displayed (step S57). The error message may be, for example, a content such as “The QC result cannot be approved. Check the analyzer”.

Next, it is determined whether or not all the search results have been approved (step S58). If “No”, the process proceeds to approval of the next request (step S59). If “Yes”, the patient sample result is approved. The process ends.
In the above description, after the approval of the patient sample result in step S54, it is determined in step S55 whether or not the QC result is within the normal range, but the QC result is within the normal range. The determination as to whether or not there is may be made immediately after the search is executed (immediately after step S52).

[3] Mode 3
In mode 3, QC result approval is performed manually and patient sample result approval is automatically performed. A QC result manual approval program is used for QC result approval, and a patient sample result automatic approval program 1 is used for patient sample result approval.
The manual QC result approval procedure is the same as in mode 1 and will not be described.

(1) Approval of patient sample result The patient sample result automatic approval program 1 is used for approval of a patient sample result. FIG. 13 is a flowchart showing a processing procedure by the patient sample result automatic approval program 1.
When the program is started, first, an unapproved patient test result is acquired from the patient sample result DB (step S60). Next, it is determined whether or not the acquired patient sample result matches a predetermined approval condition (step S61). Specifically, for each measurement item of the patient sample result, a determination is made as to whether or not it is within the normal range while referring to the measurement item normal range DB stored in the hard disk 45. If it is determined that all the measurement items are within the normal range, the process proceeds to the next step. Otherwise, the patient sample result remains unapproved and the process proceeds to step S64. Whether or not the unapproved patient test result is finally approved is determined by the “manual” patient sample result approval process in mode 1 described above. When the laboratory technician judges a measurement item that is out of the normal range from the test results of other measurement items, etc., and determines that the “out” is due to the patient's disease, Approve.

If it is determined that the acquired patient sample result matches a predetermined approval condition, it is then determined whether or not the QC result of the analyzer that has analyzed the patient sample is approved (step S62). Specifically, it is determined whether or not the approval flag is “1” in the QC result DB. If it is determined that the QC result is approved, the patient sample result is approved, and the result is reflected in the patient sample result DB (step S63). Specifically, in the same manner as in mode 1, the approval level representing the approval state is updated to a predetermined value. On the other hand, if it is determined in step S62 that the QC result is unapproved, the patient sample remains unapproved and proceeds to step S64.

Next, it is determined whether or not the approval of all the patient sample results that match the reporting conditions has been completed. If “No”, the process returns to step S60, and the next unapproved patient sample result is obtained from the patient sample result DB. In the case of “Yes”, the patient sample result approval process is completed.
In the above description, it is determined whether or not the QC result has been approved in step S62 after determining whether or not the patient sample result matches the predetermined approval condition in step S61. These steps may be reversed in order.

[4] Mode 4
In mode 4, both QC result approval and patient sample result approval are automatically performed. The patient sample result automatic approval program 2 is used for the patient sample result approval (the step of automatically approving the QC result is incorporated in the patient sample result automatic approval program 2).

(1) Approval of patient sample result The patient sample result automatic approval program 2 is used for approval of the patient sample result. FIG. 14 is a flowchart showing a procedure of processing by the patient sample result automatic approval program 2.
When the program is started, first, an unapproved patient test result is acquired from the patient sample result DB (step S70). Next, it is determined whether or not the acquired patient sample result matches a predetermined approval condition (step S71). Specifically, for each measurement item of the patient sample result, a determination is made as to whether or not it is within the normal range while referring to the measurement item normal range DB stored in the hard disk 45. If it is determined that all the measurement items are within the normal range, the process proceeds to the next step. Otherwise, the patient sample result remains unapproved and the process proceeds to step S74. Whether or not the unapproved patient test result is finally approved is determined by the “manual” patient sample result approval process in mode 1 described above. When the laboratory technician judges a measurement item that is out of the normal range from the test results of other measurement items, etc., and determines that the “out” is due to the patient's disease, Approve.

Next, it is determined whether or not the QC result of the analyzer that has analyzed the patient sample is within the normal range (step S72). Specifically, it can be determined whether the QC result is within the normal range according to the above-described determination criteria (whether the target value is within the range of ± 2SD). Note that this determination criterion (whether or not it is within the range of the target value ± 2SD) is merely an example, and other determination criteria can be adopted as appropriate.

When it is determined that the QC result is within the normal range, the patient sample result is approved, and the result is reflected in the patient sample result DB (step S73). Specifically, as described in mode 1, the approval level representing the approval state is updated to a predetermined value. On the other hand, if it is determined in step S72 that the QC result is not within the normal range, the patient sample remains unapproved and the process proceeds to step S74.
Next, a determination is made as to whether or not the approval of all the patient sample results has been completed. If “No”, the process returns to step S70, and the next unapproved patient sample result is acquired from the patient sample result DB. ", The patient sample result approval process ends.
In the above description, it is determined whether or not the QC result is within the normal range in step S72 after determining whether or not the patient sample result matches the predetermined approval condition in step S71. These steps may be reversed in order.

In mode 4, since the analysis result can be automatically approved based on the quality control result information and the analysis result, the operation of the laboratory technician required for the approval of the analysis result can be simplified.

FIG. 15 is a diagram showing the configuration of another embodiment of the system of the present invention. The system according to this embodiment is different from that shown in FIG. 1 in that processing means having a function of approving QC results and patient specimen results is incorporated in the analyzer. is there. Specifically, the present system includes an analysis apparatus 10 having an analysis apparatus main body 11 and a computer 12, and a client that is connected to the computer 12 and can refer to a result analyzed by the analysis apparatus 10. The computer 2 is mainly configured. In the present embodiment, three client computers 2 are provided, and these client computers 2 are connected to the hospital host computer 4. This hospital host computer 4 is connected to the computer 12. The computer 12 is connected to a printer 19 which is an output means for outputting analysis results of patient samples.

The analyzer 10 is a blood cell counter, and the analyzer main body 11 has a sample aspirating unit 13 for taking in the blood of a patient, which is a sample, and a sample for detection (measurement) from the sample. Sample preparation unit 14, a detection unit 15 for detecting optical information and electrical information from the sample, a communication interface 17 for communication with the outside of the apparatus main body, the sample suction unit 13, the sample preparation unit 14 and the detection The control unit 16 controls the operation of the unit 15 and counts blood cells based on information obtained by the detection unit 15.

Further, as shown in FIG. 16, the computer 12 is the same as that shown in FIG. 2 except that the approval program among the programs stored in the hard disk is only the QC result manual approval program and the patient sample result manual approval program. It has the same configuration as the server computer 1 shown, and plays the same role as the server computer 1. Then, the QC result and the patient sample result can be approved in the same manner as in the mode 1 described above. In this system, since the analysis apparatus includes means for processing the analysis result, the configuration of the entire system can be simplified.
Also in the embodiment shown in FIG. 15, the same DB and program as the server computer 1 (see FIGS. 2 to 3) can be stored in the hard disk of the computer 12 of the analyzer 10.

In the clinical test information processing apparatus and the system including the same, or the clinical test information processing method using these, the analysis result is approved based on the quality control result information indicating the result of the quality control of the analyzer that analyzes the sample. Therefore, it is possible to approve only the measurement result analyzed by the analyzer that has been approved to exhibit a predetermined accuracy. For this reason, it is possible to reliably prevent problems in which analysis results measured by analyzers that require inspection and repair because the specified accuracy does not come out are reported to the doctor, and the reliability with which the quality control results are approved. Only high analysis results can be reported to the doctor.

Further, in the clinical test information processing method, in order to process the analysis result indicating the result of analyzing the sample, the computer acquires the quality control result information indicating the result of the quality control of the analyzer that analyzes the sample. And based on the quality control result information acquired by this acquisition means, it can be executed by a program that operates as a sample approval means for approving the analysis result when the analyzer analyzes the sample.

It is a figure which shows the structure of one Embodiment of the clinical test information processing system of this invention. It is a block diagram which shows the structure of the server computer in the system shown by FIG. It is explanatory drawing of the content of the hard disk in the server computer shown by FIG. It is a flowchart which shows the procedure of the process by the communication program installed in the server computer shown by FIG. It is a flowchart which shows the procedure of the process by the quality control result manual approval program installed in the server computer shown by FIG. It is a flowchart which shows the procedure of the process by the patient sample result manual approval program 1 installed in the server computer shown by FIG. It is a flowchart which shows the procedure of the process by the report program installed in the server computer shown by FIG. It is a figure which shows an example of the quality control result approval screen displayed by the client computer in the system shown by FIG. It is a figure which shows the other example of the quality control result approval screen displayed by the client computer in the system shown by FIG. It is a figure which shows an example of the patient sample result approval screen displayed by the client computer in the system shown by FIG. It is a figure which shows the other example of the patient sample result approval screen displayed by the client computer in the system shown by FIG. It is a flowchart which shows the procedure of the process by the patient sample result manual approval program 2 installed in the server computer shown by FIG. It is a flowchart which shows the procedure of the process by the patient sample result automatic approval program 1 installed in the server computer shown by FIG. It is a flowchart which shows the procedure of the process by the patient sample result automatic approval program 2 installed in the server computer shown by FIG. It is a figure which shows the structure of other embodiment of the clinical test information processing system of this invention. It is a block diagram which shows the structure of the computer of the analyzer in the system shown by FIG. It is explanatory drawing of the content of the hard disk in the computer shown by FIG.

Explanation of symbols

1 server computer 2, 3 client computer 4 in-hospital host computers 10, 20,
30 analyzers 11, 21,
31 device main body 19 printer 40 computer main body 42 display unit 45 hard disk 46 CPU

Claims (11)

A clinical test information processing apparatus that is connected to a sample analyzer via a network so that the sample analyzer performs an approval process on a sample analysis result obtained by analyzing the sample.
A storage unit for storing a sample analysis result received from the sample analyzer and a quality control analysis result that is an analysis result of the sample for quality control received from the sample analyzer;
A display unit;
Processing of displaying a input can be quality control analysis result confirmation screen of the quality control analysis approvals, the storage unit via a quality control sample analysis results approval screen to enter the approval of the quality control analysis is performed process of storing that quality control analysis is approved, information indicating whether or not the quality control analysis results have been approved is displayed, and, sample analysis result of the input can be sample analysis result confirmation screen approval It is displayed on the display unit to process and quality control analysis results have been approved, and, test bodies when the input of the sample analysis results approved is issued through the sample analysis results approval screen displayed on the display unit A control unit for executing a process of approving the analysis result,
Controller may not accept the sample analysis results if not also approved quality control analysis results in a case where the input of the sample analysis results approved is issued through the sample analysis results are displayed on the display unit approval screen Clinical laboratory information processing device characterized by Control unit, so as to enable input of the approval of the quality control analysis by selecting the measurement item to be approved clinical testing information processing apparatus according to claim 1, wherein displaying the quality control analysis result confirmation screen on the display unit. Control unit, the input of the sample analysis results confirmation screen through the sample analysis results approved is made to display if not approve the sample analysis results, a message urging the approval of the quality control analysis result on the display unit according Item 3. The clinical examination information processing apparatus according to Item 1 or Item 2. A clinical test information processing apparatus that is connected to a sample analyzer via a network so that the sample analyzer performs an approval process on a sample analysis result obtained by analyzing the sample.
A storage unit for storing a sample analysis result received from the sample analyzer, a quality control analysis result that is an analysis result of the sample for quality control received from the sample analyzer, and a predetermined condition for approving the sample analysis result;
A display unit;
Processing of displaying a input can be quality control analysis result confirmation screen of the quality control analysis approvals, the storage unit via a quality control sample analysis results approval screen to enter the approval of the quality control analysis is performed Processing to memorize that the quality control analysis result is approved, and automatically when the quality control analysis result is approved and the sample analysis result meets the predetermined condition A control unit for executing a process to approve,
The clinical test information processing apparatus, wherein the control unit does not approve the sample analysis result unless the quality control analysis result is approved even if the sample analysis result matches the predetermined condition. Control unit, so as to enable input of the approval of the quality control analysis by selecting the measurement item to be approved clinical test apparatus according to claim 4 for displaying a quality control analysis result confirmation screen. A sample analyzer that can output the sample analysis results to the outside, and the sample analyzer connected to the sample analyzer via a network so that the sample analyzer can approve the sample analysis results obtained by analyzing the sample. A clinical test information processing system comprising:
Clinical laboratory information processing device
A storage unit for storing a sample analysis result received from the sample analyzer and a quality control analysis result that is an analysis result of the sample for quality control received from the sample analyzer;
A display unit;
Processing of displaying a input can be quality control analysis result confirmation screen of the quality control analysis approvals, the storage unit via a quality control sample analysis results approval screen to enter the approval of the quality control analysis is performed process of storing that quality control analysis is approved, information indicating whether or not the quality control analysis results have been approved is displayed, and, sample analysis result of the input can be sample analysis result confirmation screen approval It is displayed on the display unit to process and quality control analysis results have been approved, and, test bodies when the input of the sample analysis results approved is issued through the sample analysis results approval screen displayed on the display unit A control unit for executing a process of approving the analysis result,
Controller may not accept the sample analysis results if not also approved quality control analysis results in a case where the input of the sample analysis results approved is issued through the sample analysis results are displayed on the display unit approval screen Clinical laboratory information processing system characterized by A sample analyzer that can output the sample analysis results to the outside, and the sample analyzer connected to the sample analyzer via a network so that the sample analyzer can approve the sample analysis results obtained by analyzing the sample. A clinical test information processing system comprising:
Clinical laboratory information processing device
A storage unit for storing a sample analysis result received from the sample analyzer, a quality control analysis result that is an analysis result of the sample for quality control received from the sample analyzer, and a predetermined condition for approving the sample analysis result;
A display unit;
Processing of displaying a input can be quality control analysis result confirmation screen of the quality control analysis approvals, the storage unit via a quality control sample analysis results approval screen to enter the approval of the quality control analysis is performed Processing to memorize that the quality control analysis result is approved, and automatically when the quality control analysis result is approved and the sample analysis result meets the predetermined condition A control unit for executing a process to approve,
The clinical test information processing system, wherein the control unit does not approve the sample analysis result unless the quality control analysis result is approved even if the sample analysis result matches the predetermined condition. An analysis means for analyzing a sample and obtaining a sample analysis result;
A storage unit for storing the sample analysis result obtained by analyzing the sample by the analysis means and the quality control analysis result obtained by analyzing the quality control sample by the analysis means;
A display unit;
Processing of displaying a input can be quality control analysis result confirmation screen of the quality control analysis approvals, the storage unit via a quality control sample analysis results approval screen to enter the approval of the quality control analysis is performed process of storing that quality control analysis is approved, information indicating whether or not the quality control analysis results have been approved is displayed, and, sample analysis result of the input can be sample analysis result confirmation screen approval It is displayed on the display unit to process and quality control analysis results have been approved, and, test bodies when the input of the sample analysis results approved is issued through the sample analysis results approval screen displayed on the display unit A control unit for executing a process of approving the analysis result,
Controller may not accept the sample analysis results if not also approved quality control analysis results in a case where the input of the sample analysis results approved is issued through the sample analysis results are displayed on the display unit approval screen An analysis device characterized by. An analysis means for analyzing a sample and obtaining a sample analysis result;
Sample analysis result obtained by analyzing the sample by the analysis means, accuracy control analysis result obtained by analyzing the quality control sample by the analysis means, and predetermined conditions for approving the sample analysis result A storage unit;
A display unit;
Processing of displaying a input can be quality control analysis result confirmation screen of the quality control analysis approvals, the storage unit via a quality control sample analysis results approval screen to enter the approval of the quality control analysis is performed Processing to memorize that the quality control analysis result is approved, and automatically when the quality control analysis result is approved and the sample analysis result meets the predetermined condition A control unit for executing a process to approve,
The controller is characterized in that the sample analysis result is not approved if the quality control analysis result is not approved even if the sample analysis result matches the predetermined condition. In order to perform the approval process of the sample analysis result obtained by analyzing the sample by the sample analyzer, the quality control analysis is the sample analysis result received from the sample analyzer and the analysis result of the quality control sample received from the sample analyzer In a computer provided with a storage unit for storing the results and a display unit,
A process of displaying a quality control analysis result approval screen on the display unit, which allows input of approval of the quality control analysis result,
A process of storing that are approved quality control analysis results in the storage unit via a quality control sample analysis result confirmation screen Ru made to enter the approval of the quality control analysis,
Quality control analysis results are displayed information indicating whether it is authorized, and the process of displaying a capable sample analysis result confirmation screen input sample analysis results approved,
Quality control analysis results have been approved, and, running and a process to approve test body analysis results when the input of the sample analysis results through the sample analysis results approval screen displayed on the display unit approval is made Let
It does not perform the process to approve the sample analysis results if not also approved quality control analysis results in a case where the input of the sample analysis results approved is issued through the sample analysis results are displayed on the display unit approval screen A clinical information processing program characterized by In order to perform the approval processing of the sample analysis result obtained by analyzing the sample by the sample analyzer, the quality control analysis is the sample analysis result received from the sample analyzer and the analysis result of the quality control sample received from the sample analyzer In a computer having a storage unit for storing a predetermined condition for approving the result and the sample analysis result, and a display unit,
A process of displaying a quality control analysis result approval screen on the display unit, which allows input of approval of the quality control analysis result,
A process of storing that are approved quality control analysis results in the storage unit via a quality control sample analysis result confirmation screen Ru made to enter the approval of the quality control analysis,
A process for automatically approving the sample analysis result when the quality control analysis result is approved and the sample analysis result matches the predetermined condition;
A program for clinical laboratory information processing, wherein even if a sample analysis result matches the predetermined condition, a process for approving the sample analysis result is not executed unless the quality control analysis result is approved.

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