JP2006031264A - Clinical inspection information control device, clinical inspection information control method, and clinical inspection information control program - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To systematically manage information on clinical inspection and evaluate the result of the inspection in terms of quality. <P>SOLUTION: A clinical inspection information control device is provided with; an inspection-related information collection part 150 which collects the analytical data on analytes to be inspected and information accompanying the inspection of the analytes; a database 151 which correlates the analytical data collected by the inspection-related information collection part 150 with the information accompanying the inspection of the analytes and stores them; and a reference value conformity determination part 152 which determines whether the analytical data collected by the inspection-related information collection part 150 and the information accompanying the inspection of the analytes each conform to a preliminarily fixed reference value. <P>COPYRIGHT: (C)2006,JPO&NCIPI

Description

  The present invention relates to a clinical test information management apparatus, a clinical test information management method, and a clinical test information management program for managing information related to clinical tests.

  Conventionally, clinical examinations at medical facilities have been managed by the clinical examination system (LIS: Laboratory Information System) from the reception of examinations to the examination flow, such as reporting and data management, to improve work efficiency and share information. (For example, see Patent Document 1 below.)

  In addition, clinical tests are required to provide accurate and objective information, and various techniques have been developed to improve the accuracy (see, for example, Patent Document 2 below). The accuracy of information provided by clinical tests is the first requirement when considering the reliability of clinical tests, that is, the quality of tests, and inaccurate information lacking objectivity is immediately required. It leads to medical malpractice. Here, “accurate” means that the physiological or pathological state of the subject is correctly shown. The purpose of conducting a clinical test is to obtain “accurate” test results.

  Although the results of clinical tests customarily do not reveal errors with respect to measurement results and the degree of reliability is not described, as described above, the information provided in the act directly related to human life as medical care is Quality must be assured. For this reason, in recent years, the number of facilities that obtain ISO certification that guarantees the quality of medical practices and services based on an objective evaluation has been increasing in medical facilities. Is required.

JP 2003-166888 A Japanese Patent Laid-Open No. 2003-232796

  However, a clinical test is composed of a series of operations starting from sample collection, and each operation determines the accuracy of the final test result. Even if the accuracy of each inspection procedure is improved by a technique for improving the accuracy of each inspection procedure as in Patent Document 2, if the accuracy information of these individual inspection procedures is not systematized and managed, the entire inspection is performed. The quality of can not be evaluated.

  In addition, although the conventional clinical inspection system including the above-mentioned Patent Document 1 can manage the inspection flow, it does not verify the information (data) of each operation, and thus evaluates the quality of the inspection. I couldn't do it.

  Furthermore, since conventional clinical laboratory systems do not systematically manage individual work information, if a medical accident occurs, use the individual work information to investigate the cause, prevent recurrence, It was also difficult to prevent.

  In order to solve the above-described problems caused by the prior art, the present invention systematically manages information on clinical examinations and can perform quality evaluation on examination results, clinical examination information management method, and The purpose is to provide a clinical laboratory information management program.

  In order to solve the above-described problems and achieve the object, the clinical test information management apparatus according to the invention of claim 1 is a test for collecting analysis data of a sample related to the test and information accompanying the test of the sample Related information collection means, information holding means for associating and holding the analysis data collected by the examination related information collection means, and information accompanying the examination of the specimen, and the information collected by the examination related information collection means Reference value conformity determining means for determining whether the analysis data and the information accompanying the specimen test conform to a reference value provided in advance, respectively.

  According to the first aspect of the present invention, in the clinical examination, the analysis data of the specimen to be examined and the information accompanying the examination can be collected, and these information can be correlated and held. In addition, it can be determined whether the analysis data and the information accompanying the inspection conform to a predetermined reference value.

  Further, the clinical laboratory information management device according to the invention of claim 2 is the analysis data or the sample that is determined not to conform to the reference value by the reference value conformity determining means according to the invention of claim 1. It is characterized by comprising nonconformity information notifying means for notifying the user of information accompanying the inspection.

  According to the second aspect of the present invention, it is possible to notify the user when the analysis data or the information accompanying the examination of the sample does not match the reference value.

  According to a third aspect of the present invention, in the clinical laboratory information management device according to the second aspect, the nonconformity information notifying means is the information holding means, and the analysis data or the specimen to be notified to the user. The analysis data held in association with the information accompanying the examination or the information accompanying the specimen examination is notified to the user.

  According to the third aspect of the present invention, it is possible to notify analysis data that does not conform to the reference value or information associated with information associated with the specimen examination.

  According to a fourth aspect of the invention, there is provided the clinical laboratory information management device according to any one of the first to third aspects, wherein the reference value conformity determining means is a reference value in which the analysis data is provided in advance. If it does not conform to the above, a reexamination instruction means for instructing reanalysis of the sample is provided.

  According to the fourth aspect of the present invention, when the analysis data does not match the reference value, the sample can be retested.

  The clinical test information management apparatus according to claim 5 is the clinical test information management apparatus according to claim 4, wherein the reference value conformity determining means is based on the analysis data and information accompanying the test of the sample. Quality assurance judgment means for evaluating the quality of the inspection is provided.

  According to the fifth aspect of the present invention, the quality of the examination can be evaluated based on the analysis data and the information relating to the examination of the specimen.

  According to a sixth aspect of the present invention, there is provided a clinical test information management method comprising: a test information collecting step for collecting analysis data of a sample related to a test and information accompanying the test of the sample; and the test information collecting step. An information association step for associating the collected analysis data with information associated with the examination of the sample, the analysis data collected in the examination information collection step, and information associated with the examination of the sample are each in advance. And a reference value conformity determination step for determining whether the reference value is satisfied.

  According to the invention described in claim 6, in the clinical examination, the analysis data of the specimen to be examined and the information accompanying the examination can be collected and the information can be correlated. In addition, it can be determined whether the analysis data and the information accompanying the inspection conform to a predetermined reference value.

  According to a seventh aspect of the present invention, there is provided a clinical test information management method according to the sixth aspect of the present invention, wherein the analysis data or the specimen that is determined not to match the reference value in the reference value conformity determining step is tested. A non-conformance information notification step of notifying the user of information accompanying the information.

  According to the seventh aspect of the present invention, the user can be notified when the analysis data or the information accompanying the sample examination does not match the reference value.

  Further, the clinical test information management method according to the invention of claim 8 is the invention according to claim 7, wherein the nonconformity information notification step is the information association step, wherein the analysis data or the sample to be notified to the user is sent. The analysis data associated with the information accompanying the examination or the information accompanying the examination of the specimen is notified.

  According to the eighth aspect of the present invention, it is possible to notify information associated with analysis data that does not conform to the reference value or information accompanying the examination of the specimen.

  The clinical laboratory information management method according to the invention of claim 9 is the invention according to any one of claims 6 to 8, wherein the reference value conformity judgment step includes a reference value in which the analysis data is provided in advance. In the case of not conforming to the above, a reexamination instruction step for instructing reanalysis of the sample is included.

  According to the ninth aspect of the present invention, when the analysis data does not match the reference value, the specimen can be retested.

  Further, the clinical test information management method according to the invention of claim 10 is the invention according to claim 9, wherein the reference value conformity determining step is based on the analysis data and information accompanying the test of the sample. It includes a quality assurance judgment process for evaluating the quality of inspection.

  According to the tenth aspect of the present invention, the quality of the examination can be evaluated based on the analysis data and the information relating to the examination of the specimen.

  A clinical laboratory information management program according to the invention of claim 11 causes a computer to execute the clinical laboratory information management method according to any one of claims 6 to 10.

According to the eleventh aspect of the present invention, it is possible to cause a computer to execute the clinical test information management method according to any one of the sixth to tenth aspects.

  According to the clinical test information management apparatus, the clinical test information management method, and the clinical test information management program according to the present invention, it is possible to systematically manage information related to clinical tests and perform quality evaluation on test results. Play.

  Exemplary embodiments of a clinical test information management apparatus, a clinical test information management method, and a clinical test information management program according to the present invention will be described below in detail with reference to the accompanying drawings.

  First, the system configuration of the clinical test system 100 according to the present embodiment will be described with reference to FIG. FIG. 1 is a diagram showing a system configuration of a clinical test system 100. The clinical test system 100 includes a test information management apparatus 101 and a plurality of clients 102 (102a to 102c).

  The inspection information management apparatus 101 is connected to a client 102, a higher-level management apparatus 105, and a plurality of analysis apparatuses 106 (106a, 106b), which will be described later, via a network, and accepts inspections, prepares inspections, captures inspection results, and reports. Creation, search, statistics, quality control, etc. Hereinafter, main functions of the inspection information management apparatus 101 will be described.

  The examination acceptance is an examination acceptance process, and includes request information registration processing to the examination information management apparatus 101 and sample arrival confirmation processing. This is because there may be a time lag between the inspection request and the arrival of the specimen depending on the department. For example, many of the requests from the ward medical department are advance requests according to the doctor's medical treatment schedule, and the examination request form and the sample are separately delivered to the laboratory. On the other hand, in the case of a request from the outpatient department, the request form and the sample arrive in a concentrated manner almost simultaneously due to a request from the outpatient clinic or central blood collection room. These requests are made from the client 102 arranged in each department via the upper management apparatus 105.

  The inspection preparation is a sorting operation and a dispensing operation for each analysis processing unit according to the worksheet. As a specific process, when the analyzer 106 is converted into a barcode, the barcode attached to the sample arriving from the medical department is read by the barcode reader and the arrival confirmation (acceptance of the sample) is performed. , Output dispensing labels, and stick them to test tubes for measurement. The information in the bar code includes a reception date, a reception number, and a blood collection container type. Furthermore, as a human readable information, a patient name, a patient name, a ward name, a container name, an emergency, an infected specimen mark, a blood collection amount, and the like are printed.

  The inspection result is acquired by acquiring the analysis data measured by the analyzer 106 via a network or a keyboard. The examination information management apparatus 101 retrieves analysis data, searches for previous measurement values of the same patient, and performs a previous value check. In addition, messages such as quality control rules, error messages sent from the analysis device 106, re-inspection information, abnormal value information, and data errors are output to a screen or a result data file.

  The report is prepared for the final report on the inspection. In the case of an ordering system, the results are already reported in real time in many cases. Therefore, the inspection department often outputs all items as a single sheet. In other cases, a report is prepared for each department. When the inspection information management apparatus 101 creates a report, it searches all data files of inspection results and outputs data of records that have no uninspection. Also, once output, the output completion flag is written to the file so that it is not output again when searching for the second and subsequent times.

  The search is used for confirming the result of the examination in the examination department. Furthermore, the examination department can retrieve and examine the examination result data of the patient from various angles, and can make use of it for the examination. It is possible to specify the patient ID and examination date of the target patient, confirm the examination data, designate the measurement range of the results of a plurality of examination items, and output the result to a file.

  Statistics are statistics of various data from the inspection result file. For example, request item statistics on a daily basis, item-by-request-by-request item statistics, and insurance score aggregation. These statistical results are used after file output and graphing as in the search.

  Accuracy control is an important function for maintaining the accuracy of clinical tests. The accuracy management methods include Xber-S, Xber-R control charts, accuracy management methods using control samples such as twin plots, and accuracy by patient samples that compare with previous measurement values of patient data when the analyzer 106 is online. There are management methods. Note that Xber's bar is indicated by a horizontal line on the X character as shown by H in FIG. Recently, instead of a statistical method, an appearance record method has been developed in which examination analysis data is processed from a 3D distribution map of the total number of patient data, and specimens outside the data appearance record zone are detected.

  As described above, the test information management apparatus 101 has various functions that control a plurality of devices and operations in clinical tests. In addition to such a function, the inspection information management apparatus 101 further performs “reference value conformance determination” for determining whether the inspection result satisfies a certain reference value.

  The reference value conformity determination is to determine whether a certain reference value is provided for each piece of inspection related information received from the client 102, the analysis device 106, etc. at each processing stage of the inspection, and whether or not it conforms to this. . Here, the examination-related information received from each apparatus is specimen traceability information, apparatus information, material information, examination procedure information, final quality assurance information, and the like.

  Specimen traceability information includes time information such as test acceptance information, preprocessing time, measurement time, retest time, and report time, as well as sample names such as the worker name and elapsed time (TAT) from arrival to report. Tracking information. The device information is information relating to each device used for inspection such as calibration information, quality control information, work time, and worker name.

  The material information is information on various materials used for inspection, such as reagent and consumable lot information, purchase information, purchaser name, and purchase date and time. The inspection procedure manual information is information relating to inspection work procedures such as reference values and re-examination standards. The final quality assurance information is information related to a person responsible for the final quality assurance related to the inspection.

  The inspection information management apparatus 101 determines whether or not the quality can be guaranteed for the entire inspection after determining whether these pieces of information satisfy a preset reference value. In addition, information related to clinical tests is usually distributed and held in each device or department, but can be effectively used as data by systematically holding the test information management device 101. it can.

  Returning to the description of FIG. 1, the clients 102 (102 a to 102 c) are arranged in various places in the medical facility, and make an examination request, input various information, and the like to the examination information management apparatus 101. In addition, each piece of information that the inspection information management apparatus 101 has is displayed.

  The upper management apparatus 105 is called a hospital information system (HIS) and includes a medical office accounting system, a medical appointment reservation system, a medical information system, and an information processing system for each department such as medical examinations and medicines. Is a comprehensive system. The clinical test system 101 is a subordinate system of the upper management apparatus 105, and accepts an examination request from another system such as a medical care system via the upper management apparatus 105.

  The analysis device 106 (106a, b) performs various types of analysis processing on the specimen and outputs the analysis result to the examination information management device 101 or the like. In addition, the analysis device 106 transmits a start inspection result, calibration information, and the like to the inspection information management device 101 as needed. Calibration refers to obtaining a relationship between a value represented by a measuring instrument (analyzer) and a true value using a standard device or a standard sample. The calibration information supports the reliability of the measurement value of the analyzer 106.

  Next, the configuration of the inspection information management apparatus 101 will be described with reference to FIG. FIG. 2 is a diagram illustrating an internal configuration of the inspection information processing apparatus 101. The examination-related information collection unit 150 receives the above-described examination-related information output from the upper management device 105 or the analysis device 106 and outputs the information to the database (DB) 151 and the reference value conformity determination unit 152. If necessary, examination-related information can be requested from the upper management apparatus 105 and the analysis apparatus 106.

  The database (DB) 151 holds the examination related information collected by the examination related information collection unit 150. At this time, the examination-related information is held after being associated with the analysis data obtained from the specimen. The database 151 also stores determination results output from a reference value conformity determination unit 152 (to be described later) in association with analysis data.

  As described above, the examination-related information can be systematically held by associating and holding various kinds of examination-related information for each specimen to be examined. In the unlikely event that a medical accident occurs, the cause of the medical accident can be investigated by tracking information associated with the specimen.

  The reference value conformity determination unit 152 includes a re-inspection determination unit 153 and a quality assurance determination unit 155. It is determined whether the inspection-related information output from the inspection-related information collecting unit 150 matches a reference value set by a re-inspection reference value setting unit 154 and a quality assurance reference value setting unit 156 described later.

  The re-inspection determination unit 153 includes a re-inspection standard set by a re-inspection reference value setting unit 154 to be described later with respect to analysis data by the analysis device 106 among the inspection-related information collected by the inspection-related information collection unit 150. It is determined whether reinspection is performed based on the value (hereinafter referred to as “reinspection necessity determination”).

  When it is determined that retesting is necessary, a retesting instruction is given to the analyzer 106 via the test related information collecting unit 150. Further, whether the analyzer 106 is operating normally is monitored. If the analyzer 106 is not operating normally, an internal setting of the analyzer 106 is changed or a user is notified via a notification unit 158 described later. The result of the reinspection necessity determination and the analysis data are output to the database 151 and the quality assurance determination unit 155. Note that the inspection related information other than the analysis data output from the inspection related information collecting unit 150 is not processed by the reinspection determination unit 153 and is output to the quality assurance determination unit 155.

  The reexamination reference value setting unit 154 individually sets the reexamination reference value for the analysis data of the sample output from the analyzer 106. In addition, the reinspection reference value setting unit 154 outputs the set reinspection reference value to the reinspection determination unit 153.

  The quality assurance determination unit 155 determines whether or not the quality of the inspection result can be guaranteed (hereinafter, this determination is referred to as “quality assurance determination”). In determining the quality assurance availability, the inspection related information collected by the inspection related information collecting unit 150 and the reinspection necessity determination result output from the reinspection determining unit 153 are used. The quality assurance determination unit 155 determines whether each of these pieces of information conforms to a quality assurance reference value set by a quality assurance reference value setting unit 156 described later. Furthermore, the judgment for each piece of information is integrated to judge whether the inspection conforms to the quality assurance standard value and the quality can be guaranteed. The result of the quality assurance determination is output to the output unit 157 and the database 151.

  Further, when the quality assurance determination unit 155 determines that the quality assurance cannot be performed on the inspection result, the quality assurance determination unit 155 outputs the inspection related information that causes the inspection result and information associated with the information to the output unit 157. It is judged that quality assurance cannot be performed because there may be some deficiencies or accidents in the inspection process. At this time, the output information includes many items, and it is very difficult to understand only by listing them. Therefore, a characteristic factor diagram is created and output to the output unit 157. Details of this characteristic factor diagram will be described later.

  The quality assurance reference value setting unit 156 individually sets a reference value for each of the inspection related information collected by the inspection related information collecting unit 150 and the information on the determination result of the necessity of reinspection output from the reinspection determination unit 153. Set. Further, the quality assurance reference value setting unit 156 outputs the set quality assurance reference value to the quality assurance determination unit 155.

  The output unit 157 outputs the quality assurance availability determination result of the inspection result output from the quality assurance determination unit 155 and the characteristic factor diagram to the notification unit 158. The determination result and the characteristic factor diagram are also output to the upper management apparatus 105 and the client 102. The notification unit 158 notifies the user of the quality assurance availability determination result and the characteristic factor diagram of the inspection result output from the output unit 157 using a display screen or sound.

  Next, a procedure for determining whether or not re-examination is necessary will be described with reference to FIG. FIG. 3 is a flowchart showing a procedure for determining whether or not re-examination is necessary, which is performed by the inspection information management apparatus 101.

  First, analysis data is input from the analyzer 106 to the examination related information collection unit 150 (step S181). The inspection related information collection unit 150 outputs the input analysis data to the reinspection determination unit 153 and the database 151. The reexamination determination unit 153 determines whether the analysis data satisfies the reexamination standard value determined by the reexamination standard value setting unit 154 (step S182).

  When the analysis data does not satisfy the reinspection reference value (step S182: No), it is confirmed whether the analyzer 106 is operating normally (step S183). If the analyzer 106 is operating normally (step S183: Yes), the analyzer 106 is instructed to perform remeasurement (step S185). If the analyzer 106 is not operating normally (step S183: No), maintenance is performed on the analyzer 106 (step S184), and a remeasurement instruction is issued. This maintenance may be performed by changing the internal settings of the analyzer 106 by the reexamination determination unit 153 or notifying the user of the abnormality of the analyzer 106 via the notification unit 158 and performing repairs by the user.

  On the other hand, when the analysis data satisfies the re-inspection reference value (step S182: Yes), it is determined whether a comment is necessary (step S186). The comment is attached when the analysis data satisfies the re-inspection standard value but there is a special note in the measurement process (for example, analysis data by re-measurement). If it is determined that a comment is necessary (step S186: Yes), a comment is created (step S187), and is output to the quality assurance determination unit 155 together with the determination result of the necessity of re-examination and analysis data (step S188). When it is determined that the comment is not necessary (step S186: No), the comment is not created, and the determination result on whether reinspection is necessary and the analysis data are output to the quality assurance determination unit 155 (step S188). Through the processing as described above, the inspection information management apparatus 101 performs re-inspection determination processing, and ensures the reliability of the analysis data by the analysis apparatus 106.

  Next, an operation when the inspection information management apparatus 101 determines whether or not quality assurance is possible will be described with reference to FIG. FIG. 4 is a flowchart showing a procedure of quality assurance availability determination processing performed by the inspection information management apparatus 101.

  The analysis device 106 outputs the result of the start-up inspection, calibration information, and the like as inspection data to the inspection information management device 101 as needed (step S251). The inspection related information collection unit 150 of the inspection information management apparatus 101 collects inspection data output from the analysis apparatus 106 and stores it in the database 151 (step S201).

  When a sample inspection request is made, the host management apparatus 105 outputs the inspection request information to the inspection information management apparatus 101 (step S261). The examination request information includes examination contents, patient information, and the like. The examination related information collection unit 150 collects the examination request information output from the upper management apparatus 105 and stores it in the database 151 (step S202).

  When the specimen to be examined arrives, specimen arrival information is output from the upper management apparatus 105 (step S262). This is because, as described above, the test request and the sample may arrive separately or at the same time. The examination related information collection unit 150 collects the arrival information of the sample output from the upper management apparatus 105 and stores it in the database 151 (step S203).

  When the inspection of the arrived sample is started, the analyzer 106 outputs analysis data obtained by analyzing the sample (step S252). The examination related information collection unit 150 collects the analysis data transmitted from the analysis device 106 and outputs the collected analysis data to the reexamination determination unit 153 and the database 151 (step S204).

  Next, the reexamination determination unit 153 determines whether reexamination is necessary for the analysis data output from the inspection related information collection unit 150 (step S205). When the analysis data satisfies the reinspection reference value (step S206: Yes), the process proceeds to step S208.

  On the other hand, when the reinspection reference value is not satisfied (step S206: No), a reinspection instruction is given to the analyzer 106 (step S207). Receiving the reexamination instruction, the analyzer 106 performs the analysis process on the sample again and outputs the analysis data (step S252). The examination-related information collection unit 150 collects analysis data obtained by re-inspection of the analyzer 106 that has received the re-inspection instruction (step S252), and repeats the above procedure.

  Next, the quality assurance determination unit 155 determines whether or not quality assurance is possible for the inspection result (step S208). In determining whether quality assurance is possible, in addition to the analysis data, information output from the upper management apparatus 105 or the analysis apparatus 106 in steps S201 to S204, inspection-related information input from the client 102 or the like as needed and stored in the database 151 Information is used. The quality assurance determination unit 155 determines whether these pieces of information are compatible with the quality assurance determination criterion value set by the re-inspection reference value setting unit 154. In addition, the judgment on each piece of information is integrated to judge whether the result of the inspection conforms to the quality assurance standard value.

  A clinical test consists of a series of operations starting from the collection of specimens, and each operation determines the correctness of the final test results. Therefore, it is possible to guarantee the quality of the entire inspection for the first time by determining whether all the data related to the inspection conforms to a predetermined reference value.

  If it is determined that the quality of the inspection can be guaranteed (step S209: Yes), the inspection result is transmitted to the upper management apparatus 105 (step S213), and the processing according to this flowchart ends.

  On the other hand, if it is determined that quality assurance cannot be performed (step S209: No), a quality assurance characteristic factor diagram is created and displayed on the notification unit 158 (step S210). The characteristic factor diagram is a diagram that systematically summarizes the relationship between the characteristic in question and the factors that are thought to have an influence on it, in a figure like a fish bone. In the present system, the characteristic in question is that the inspection result did not reach the quality assurance standard value.

  Then, the cause of the quality assurance of the inspection result is investigated based on the characteristic factor diagram (step S211). According to the characteristic factor diagram, the result that the quality assurance reference value has not been reached and the relationship between the causes can be organized in a diagram. In addition, improvement means can be organized in a diagram, so that information can be read immediately and deeply understood. Problems that are often overlooked by numbers alone are easily graphed and discovered.

  If the cause is investigated, the cause is eliminated (step S212), and the analysis device 106 performs the analysis again. The examination related information collection unit 150 collects analysis data output by the analysis device 106 (step S204), and repeats the subsequent steps until the processing is completed.

  By the operation as described above, the inspection information management apparatus 101 determines whether or not quality assurance is possible. As described above, when quality assurance is not performed for the inspection result, re-inspection or the like is performed. In this case, a warning screen as shown in FIG. 5 is displayed on the notification unit 158 or the client 102. Is displayed. FIG. 5 is an example of a display screen of the clinical examination system 100.

  When quality assurance is not performed on the test result, a non-conforming screen 301 is displayed on the display screen of the clinical test system 100 as shown in FIG. The nonconforming screen 301 is a simplified display of a characteristic factor diagram described later, and indicates which element has a problem among the elements of the quality assurance reference value. When the nonconforming screen 301 is clicked, a detailed characteristic factor diagram is displayed.

  FIG. 6 shows an example of the characteristic factor diagram displayed when the nonconforming screen 301 is clicked. FIG. 6 is an example of a characteristic factor diagram created and displayed by the clinical examination system 100. In FIG. 6, a main branch (spine) 401 leading to quality assurance of the inspection result protrudes from the main branches (spine) 402a to 402f, each element for determining whether or not the quality of the inspection result can be guaranteed. ing.

  The branch 402a is a branch in which the elements of the request system are gathered, and includes items 403a to 403c such as a request time, a request incidental item, and a requester. The large branch 402b is a branch that summarizes the elements of the specimen collection system, and includes items 403d to 403i such as the presence / absence of explanation for the patient, blood collection conditions, and the person in charge of specimen collection. Similarly, storage and transfer system items 403j to l are included in the branch 402c, measurement items 403m to q are included in the branch 402d, statistical accuracy assurance items 403r to u are included in the branch 402e, and individual data is stored in the branch 402f. Assurance-related items 403v to 403 are included, respectively.

  Further, the items of the measurement system are further composed of several factor systems, and the middle branches 404a to 404c protrude from the large branch 402d. The middle branch 404a is a branch in which the elements of the secondary standard substance system are collected, and includes items 405a to 405c such as a standard substance lot, a purchase date, and a secondary standard substance name. Similarly, the middle branch 404b includes calibration items 405d to 405g, and the middle branch 404c includes reagent items 405h to j. In addition, like the item 405k, the item may branch from another item 403o.

  Gates 406a to 406f are provided at the junctions between the main trunk 401 and the branches 402a to f. The gates 406a to 406f determine whether the items in each system included in the respective branches 402a to 402f satisfy the quality assurance standard value, and if any one does not satisfy the quality assurance standard value, they are displayed in red. (Black circle in the figure). On the other hand, when all items satisfy the quality assurance standard value, the gates 406a to 406f are displayed in blue (white circles in the figure). If all the gates 406a-f are not displayed in blue, quality assurance is not performed. That is, in order for the inspection result to satisfy the quality assurance standard value, all items need to satisfy the quality assurance standard value. In the example shown in the drawing, the sample collection system gate 406b and the storage / transfer system gate 406c are displayed in red, and it is understood that any of these items does not satisfy the quality assurance standard.

  In addition, by clicking each item 403a-x, a specific value of the item can be displayed, and the data of the determination item for determining quality assurance can be directly confirmed. As a result, when quality assurance is not performed for the inspection result, the cause can be immediately investigated, and recurrence prevention can be achieved at an early stage.

  For example, when the requested items 403a to 403c shown in the branch 402a are clicked, information on the inspection request status as shown in FIG. 7 is displayed. FIG. 7 is an example of a display screen of the clinical test system 100. Information corresponding to items 403a to 403c such as a request date, a request time, and a requester for the inspection is displayed (A in the figure). The requested inspection item is also displayed (B in the figure).

  Similarly, when the blood collection item 403d-i shown in the large branch 402b is clicked, information related to blood collection processing as shown in FIG. 8 is displayed. FIG. 8 is an example of a display screen of the clinical examination system 100. Information corresponding to items 403d-i such as blood collection time, presence / absence of patient explanation, blood collection conditions, etc. is displayed (C in the figure). A specimen to be examined is barcoded at the same time it is collected from a patient. In each process during the examination, the sample is barcode-controlled, and information such as the person in charge of each process and the required time is recorded one by one. These pieces of information are factors for determining whether or not quality assurance is possible.

  FIG. 8 also displays information corresponding to the items 403j to 403 of the storage and transfer system shown in the branch 402c (D in the figure). In the process while the sample after the blood collection process is carried into the laboratory, information regarding each process is recorded one by one by bar code management, which is an element for determining quality assurance.

  When the measurement system items 403m to q and 405a to 405a to k shown in the branch 402d are clicked, information on the measurement under examination as shown in FIG. 9 is displayed. FIG. 9 is an example of a display screen of the clinical examination system 100. Information related to the measurement includes information on the measurement process itself (patient name, examination date, etc.), specifications and calibration information of the analyzer 106 (E in the figure), and information on the reagent used in the measurement (in the figure) F) and the like are also included.

  Calibration refers to checking whether various measuring instruments including the analyzer 106 are measuring correctly with another measuring instrument that is controlled with high precision and strictness, and repairing and adjusting if necessary. is there. The analysis device 106 periodically receives such an inspection, and manages the accuracy of the measurement value.

  When the items 403 r to u of the statistical accuracy assurance system shown in the branch 402 e are clicked, a statistical evaluation for the examination as shown in FIG. 10 is displayed. FIG. 10 is an example of a display screen of the clinical examination system 100. The inspection information management apparatus 101 creates a statistical management table indicated by H and I in the figure from each data indicated by G in the figure. In the figure, H is an Xber management chart, and I in the figure is an S management chart, and accuracy management is performed by a general Xber-S management projection as an accuracy management projection.

  When the individual data guarantee system item 403v-x shown in the branch 402f is clicked, the test result of the individual data as shown in FIG. 11 is displayed. FIG. 11 is an example of a display screen of the clinical examination system 100. In the figure, J is the result of the clinical laboratory variation tolerance test from the previous examination date by the appearance record zone method.

  When the item 403q indicating the measurement principle is clicked, the inspection principle and inspection procedure of the inspection are displayed as shown in FIG. FIG. 12 is an example of a display screen of the clinical examination system 100. The inspection principle and inspection procedure are usually held on a paper basis as an inspection procedure document in each department. However, for example, information on medical malpractice so far (K in the figure) or the appearance of the reagent can be confirmed with an image (L in the figure), which has conventionally been stored separately as data As a result, availability can be further increased. Moreover, the possibility of preventing medical accidents by increasing the data and making it possible for all persons involved in the inspection to confirm the data increases.

  As described above, according to the clinical test system 100 according to the present embodiment, it is possible to systematically manage information related to clinical tests and perform quality evaluation on test results based on preset reference values. . This makes it easy to guarantee the quality of clinical tests based on objective data, and can be used effectively for obtaining ISO certification.

  Moreover, since evaluation is performed at any time for each process of clinical examination, it is possible to prevent medical accidents and medical errors. In the unlikely event that a medical accident occurs, it is possible to investigate the cause by tracking examination related information and prevent recurrence.

  As described above, the clinical test information management apparatus, the clinical test information management method, and the clinical test information management program according to the present invention are useful for management of information related to clinical tests, and in particular, in the clinical test information system (LIS). Is suitable.

1 is a diagram showing a system configuration of a clinical test system 100. FIG. It is a figure which shows the internal structure of the test | inspection information management apparatus 101. FIG. It is a flowchart which shows the reexamination judgment process which the inspection information management apparatus 101 performs. It is a flowchart which shows the procedure of the quality assurance availability judgment process which the test | inspection information management apparatus 101 performs. It is a figure which shows an example of the display screen of the clinical test system. It is a figure which shows an example of the characteristic factor figure produced and displayed with the clinical test system. It is a figure which shows an example of the display screen of the clinical test system. It is a figure which shows an example of the display screen of the clinical test system. It is a figure which shows an example of the display screen of the clinical test system. It is a figure which shows an example of the display screen of the clinical test system. It is a figure which shows an example of the display screen of the clinical test system. It is a figure which shows an example of the display screen of the clinical test system.

Explanation of symbols

DESCRIPTION OF SYMBOLS 100 Clinical test system 101 Test information management apparatus 102a-c Client 105 High-order management apparatus 106a, b Analysis apparatus 150 Test related information collection part 151 Database 152 Reference value conformity judgment part 153 Reexamination judgment value part 154 Retest standard value setting part 155 Quality Warranty Judgment Unit 156 Quality Assurance Standard Value Setting Unit 157 Output Unit 158 Notification Unit

Claims (11)

A test-related information collecting means for collecting analysis data of a sample to be tested and information accompanying the test of the sample;
Information holding means for holding the analysis data collected by the examination related information collecting means and information accompanying the examination of the specimen in association with each other;
Reference value conformity judgment means for judging whether the analysis data collected by the examination related information collection means and the information accompanying the examination of the specimen are each adapted to a reference value provided in advance,
A clinical laboratory information management device comprising:   The apparatus according to claim 1, further comprising: a nonconformity information notifying unit for notifying a user of the analysis data determined to be incompatible with the reference value by the reference value conformity determining unit or information accompanying the examination of the sample. The clinical laboratory information management device described.   The nonconformity information notifying means is the information holding means for displaying the analysis data or information accompanying the specimen test held in association with the analysis data notified to the user or information accompanying the specimen examination. The clinical laboratory information management device according to claim 2, wherein notification is performed.   The reference value conformity determining means includes retest instruction means for instructing reanalysis of a sample when the analysis data does not conform to a predetermined reference value. The clinical laboratory information management device according to any one of the above.   5. The clinical test according to claim 4, wherein the reference value conformity determining means includes a quality assurance determining means for evaluating the quality of the test based on the analysis data and information accompanying the test of the specimen. Information management device. A test information collecting step for collecting analysis data of a sample to be tested and information accompanying the test of the sample;
An information association step for associating the analysis data collected in the examination information collection step with information accompanying the examination of the specimen;
A reference value conformity determining step for determining whether the analysis data collected in the inspection information collecting step and the information accompanying the test of the sample conform to a predetermined reference value, respectively;
A clinical laboratory information management method comprising:   7. The nonconformity information notifying step of notifying a user of the analysis data determined not to conform to the reference value by the reference value conformity determining step or information accompanying the examination of the specimen is included. The clinical laboratory information management method described.   The non-conformity information notification step notifies the analysis data or information associated with the sample examination associated with the analysis data or information associated with the sample examination notified to the user in the information association step. The clinical laboratory information management method according to claim 7, wherein:   9. The reference value conformity determining step includes a retest instruction step for instructing a sample to be reanalyzed when the analysis data does not conform to a predetermined reference value. The laboratory information management method according to any one of the above.   The clinical test according to claim 9, wherein the reference value conformity determining step includes a quality assurance determining step of evaluating the quality of the test based on the analysis data and information accompanying the test of the specimen. Information management method. A clinical laboratory information management program that causes a computer to execute the clinical laboratory information management method according to any one of claims 6 to 10.

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