JP2008112465A - Server for clinical examination system - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To improve the convenience of accuracy management by automatically preparing a summary list for comparing a measured result of an object to be examined for accuracy management of each of a plurality of clinical examination apparatuses in a group with the totalized result of respective clinical examination apparatuses after the lapse of an expiration date of the object to be examined for accuracy management. <P>SOLUTION: A server for a clinical examination system connected to a plurality of clinical examination apparatuses installed in a plurality of facilities in one group and provided with terminals through a network is provided with a list preparation means for receiving a measured result of an object to be examined for accuracy management from the clinical examination apparatus, and when the object to be examined for accuracy management is expired, specifying the group to which the clinical examination apparatus belongs, totalizing the measured result of the object to be examined for accuracy management and the measured results of respective clinical examination apparatuses belonging to the group, and preparing a summary list for comparing the measured result with the totalized result. <P>COPYRIGHT: (C)2008,JPO&INPIT

Description

  The present invention relates to a clinical test system server, and more particularly to a server connected to a plurality of clinical test apparatuses via a network.

  As a conventional technique related to the present invention, there is known an interactive clinical laboratory system for analyzing a sample at at least one remote location at the same time and evaluating each analysis result in a central laboratory ( For example, see Patent Document 1).

US Pat. No. 6,192,320

  Such a conventional system is not considered when there are a plurality of clinical examination apparatuses in a plurality of facilities of one group. Therefore, even when there are a plurality of clinical examination apparatuses in the same group, each clinical examination apparatus is completely independent, which is inconvenient to collectively manage a plurality of apparatuses in the group. The present invention has been made in consideration of such circumstances, and after the expiration date of the quality control sample, the measurement results of each quality control sample of each of the plurality of clinical test devices in the group and each clinical test device The purpose is to automatically create a summary list for comparing the results of the above and to improve the convenience of quality control.

  The present invention has been made in consideration of such circumstances, and is a server for a clinical laboratory system that is installed at a plurality of facilities in one group and is connected to a plurality of clinical laboratory apparatuses provided with terminals via a network. An interface for communicating with each clinical examination apparatus via a network, an ID for identifying a facility as an attribute of the clinical examination apparatus, a group code for identifying a group, and a clinical examination Storage means for storing information for specifying the apparatus, measurement result storage means for storing the measurement results of the quality control samples received from each clinical testing apparatus via the interface, the type information of the quality control samples, and the production lot information; Quality control sample information storage means for storing quality control sample type information, production lot information and expiration date; Based on the quality control sample type information and manufacturing lot information received from the device, the quality control sample used for the measurement result received from the expiration date stored in the quality control sample information storage means has expired. A clinical examination from the group code stored in the storage means based on the information for identifying the clinical examination apparatus when the validity period of the quality control sample is judged to have expired For identifying the group to which the device belongs, summing up the measurement result of the quality control specimen and the measurement result of each clinical testing device belonging to the group read from the measurement result storage means, and comparing the measurement result and the summation result There is provided a clinical laboratory system server characterized by comprising a list creation means for creating a summary list.

  Further, the present invention is a clinical laboratory system server connected to a plurality of clinical laboratory apparatuses and reference clinical laboratory apparatuses, which are installed in a plurality of facilities of one group and provided with terminals, via a network, An interface for communicating with each clinical testing device via a network, an ID for specifying a facility and a group code for specifying a group are stored as attributes of the clinical testing device, and the clinical testing device is specified Storage means for storing information, measurement results of quality control samples received from each clinical testing device via interfaces, type information and production lot information of quality control samples, and reference clinical testing devices via interfaces Stores the received quality control sample measurement results, quality control sample type information and production lot information Measurement result storage means, and based on the quality control specimen type information and manufacturing lot information received from the clinical laboratory apparatus, the measurement result received from the expiration date stored in the quality control specimen information storage means was used. A determination unit that determines whether or not the expiration date of the quality control sample has expired, and a storage unit that is based on information that identifies the clinical test apparatus when the determination unit determines that the expiration date of the quality control sample has expired The group to which the clinical laboratory apparatus belongs is identified from the group code stored in the table, and the measurement results of the quality control specimen and the measurement results of the clinical laboratory apparatuses belonging to the group read out from the measurement result storage means are aggregated, and the measurement A list creation means for creating a summary list for comparing the results and the measurement results from the reference clinical test apparatus with the summary results, There is provided a for clinical inspection system server that.

  According to the present invention, the user can easily create a tabulation list for comparing the change over time in the measured value of the control sample by the clinical testing device in use after the expiration date of the control sample with the counting result of each clinical testing device in the group. Since it can be obtained, the convenience of accuracy control is increased.

  The facility in the present invention is, for example, a hospital or an inspection center, and refers to a place where one or more clinical inspection apparatuses are installed. In addition, the group means a group determined by a user's request in order to collaborately manage the accuracy of clinical testing apparatuses in at least two or more facilities.

    An example of a clinical test apparatus used in this system is a blood cell counter, which includes a measurement unit for each item and a sensor for detecting the presence or absence (error information) of each part of the device, and calculates the measurement results. It has a function to send to the server together with error information. As the apparatus, model XE-2100 manufactured by Sysmex Corporation can be used.

    As the terminal of the present invention, a general personal computer installed with communication software can be used. Moreover, the Internet can be used for the network. As the server, a server including a hard disk as various databases and a data processing unit that processes information received from the clinical testing apparatus based on a command from the terminal can be used.

    In addition, the quality control sample used in the present invention is simulated blood, simulated urine or the like (control sample) artificially prepared for quality control, and its valid use period is, for example, 50 days. For such a control sample, for example, e-CHECK made by Sysmex Corporation or UF check can be used. The total result of each clinical examination apparatus is, for example, the average value, standard deviation, maximum value, minimum value, etc. of the measurement values of the quality control samples of all (plural) clinical examination apparatuses connected to the server.

    The present invention will be described in detail below based on the embodiments shown in the drawings. FIG. 1 is an overall configuration diagram of a clinical examination system according to the present invention. The clinical test apparatuses 1, 2, 3, 7, 8, 9, and 14 are blood cell counters. For this, for example, XE-2100 (manufactured by Sysmex Corporation) can be suitably used. Terminals 4, 5, 6, 10, 11, 12, and 15 are personal computers, and software such as Windows (registered trademark) and Internet Explorer (both manufactured by Microsoft Corporation) is installed.

    Each clinical testing apparatus and terminal are connected to the server 13 via the hubs 16, 17, 18, 19 via the Internet network NW or directly. Further, the clinical testing apparatuses 1, 2, 3 and the terminals 4, 5, 6 are installed in the A hospital. The clinical examination apparatus 7 and the terminal 10 are installed in Hospital B. The clinical testing devices 8 and 9 and the terminals 11 and 12 are installed in the C testing center.

    In this embodiment, the clinical testing apparatuses are all the same model, but may be different models. The clinical testing apparatus 14 is a reference clinical testing apparatus, which is managed by the manufacturer of the clinical testing apparatus so as to maintain high measurement accuracy.

    FIG. 2 is a block diagram showing the internal configuration of the server 13. The server 13 has an ID management database (hereinafter referred to as DB) 21, an apparatus information management DB 22, an error log DB 23, a QC measurement value DB 24, a control information DB 25, a statistical value DB 26, and a QC report DB 27. These DBs are composed of hard disks.

    The server 13 also includes a device list creation unit 28, a group list creation unit 29, an online QC creation unit 30, an error log creation unit 31, a statistical value calculation unit 34, and an online QC report creation unit 33. These are composed of a CPU, ROM, RAM and the like. The server 13 further includes an interface 32, and the interface 32 can transmit and receive data by TCP / IP, for example.

    FIG. 3 is a block diagram showing the internal configuration of the clinical test apparatuses 1, 2, 3, 7, 8, 9, and 14. The clinical testing apparatus aspirates a blood sample or specimen for accuracy control (hereinafter referred to as a control specimen) from a specimen container from a specimen aspirating unit 31 and also uses a barcode attached to the specimen container as a specimen. The barcode is read by the barcode reader 32. The specimen sucked from the specimen suction section is diluted with a reagent and hemolyzed, then moves from the detection section 33 to the discharge section 34, and is discharged outside the apparatus.

    In the detection unit 33, data such as fluorescence and scattered light is acquired from the specimen by a detection data acquisition unit 35, for example, a flow cytometer. On the other hand, information read by the sample barcode reading unit 32 (information such as sample number and control sample production lot number) is sent to the blood / control sample determination unit 36.

    The blood / control sample determination unit 36 determines whether the sample is blood or a control sample. If the sample is blood, the measurement result calculation unit 37 analyzes the data acquired by the detection data acquisition unit 35 using the blood analysis program, and displays the analysis result on the display unit 38.

    If the sample is a control sample, the measurement result calculation unit 39 analyzes the data acquired by the detection data acquisition unit 35 using the control sample analysis program, displays the analysis result on the display unit 38, and sends it to the transmission data generation unit 40. Output.

    The transmission data creation unit 40 uses the acquired analysis result as the model name, serial number, and the like of the clinical testing apparatus. And the information such as the type of the control sample and the production lot number are transmitted to the server 13 via the interface 41.

    When any error (abnormality) occurs in the clinical testing apparatus, the error information creation / transmission unit 42 sends the model name, serial number, error information, and error occurrence date / time of the apparatus to the server 13 when the error occurs. Transmit via the interface 41. Here, the types of errors include apparatus internal pressure abnormality, blood suction abnormality, drainage discharge abnormality, and control sample measurement value abnormality, and are preferably classified according to the importance of the error.

    The blood / control sample determination unit 36, the measurement result calculation units 37 and 39, the transmission data creation unit 40, and the error information creation / transmission unit 42 are constituted by a CPU, a ROM, a RAM, and the like. The interface 41 can transmit and receive data by, for example, TCP / IP.

    Each clinical test apparatus measures a control sample (e-CHECK (manufactured by Sysmex Corporation) once a day in this example) and, as shown in FIG. 8, model name, serial number, type of control sample, control The production lot information, measurement item, measurement value, and measurement date of the specimen are automatically transmitted to the server 13. For each measurement item, this information includes red blood cells (RBC), platelets (PLT), white blood cells (WBC), etc. The measurement date does not necessarily need to be sent, and the date on which the server 13 receives these data may be the measurement date.

    Next, the contents of each DB in the server 13 will be described. As shown in FIG. 4, the ID management DB 21 stores an ID, a password, a facility name, and a group code.

    The ID and password are information necessary for the user to receive the service of the clinical examination system, and are registered and set for each facility (for example, hospital) where the clinical examination apparatus is installed when the service is subscribed. The group code is a code for specifying a plurality of grouped facilities. In this embodiment, hospital A and hospital B are hospitals belonging to one group.

    As shown in FIG. 5, the device information management DB 22 stores an ID, a model name, a common name (NickName), and a serial No. The common name (NickName) is a name arbitrarily given to the clinical examination apparatus by the user for convenience. Only one serial number is assigned to one clinical examination apparatus, and the apparatus can be specified.

    Control specimen measurement information shown in FIG. 8 is transmitted from each clinical testing apparatus to the server 13. When an error occurs in the clinical examination apparatus, the apparatus transmits a serial number, an error type, and an error occurrence date and time to the server 13. The error log creation unit 31 creates the table shown in FIG. 6 from the serial number received from the clinical test apparatus, the type of error, the date and time of occurrence of the error, and the information in the apparatus information management DB 22 and stores the table in the error log DB 23.

    The online QC creation unit 30 receives the information shown in FIG. 8, creates the tables shown in FIGS. 7A to 7C, and stores them in the QC measurement value DB 24. 7A shows a case where the measurement item is a red blood cell (RBC), FIG. 7B shows a case where the measurement item is platelet (PLT), and FIG. 7C shows a case where the measurement item is white blood cell (WBC).

    The control information DB 25 stores the control sample information shown in FIG. 9, that is, the type of the control sample, the production lot information of the control sample, and the expiration date of the control sample.

    In the statistical value DB 26, as shown in (a) to (f) of FIG. 10, the average value and standard deviation of the measured values of all the clinical laboratory apparatuses are provided for each lot of the control specimen, for each measurement date, and for each measurement item. Based on the measured value of each clinical testing apparatus stored in the QC measured value DB 24, the statistical value calculating unit 34 calculates and stores the calculated value. As will be described later, the QC report DB 27 stores the contents of the report shown in FIG. 11 created by the online QC report creation unit 33 based on the statistical value data stored in the statistical value DB 26.

    In such a system configuration, a list of statuses of a plurality of clinical examination apparatuses belonging to a facility and a group, which is one of the features of the present invention, is shown in FIGS. 12 and 13, respectively. In FIG. 12, the status (presence / absence of errors) of the three clinical testing apparatuses 1, 2, and 3 belonging to Hospital A are shown together with the model name and the common name. In FIG. 13, the status of the four clinical testing apparatuses 1, 2, 3, and 7 belonging to one group of A hospital and B hospital are shown together with the facility name, model name, and common name.

    In the apparatus status column in FIG. 12 and FIG. 13, a mark * is added for an error in the past 48 hours. 12 and 13 is a command button. When the user selects this button displayed on the terminal, an online QC report stored in the QC report DB 27 (for details, see FIG. 12). (To be described later) is downloaded.

    The list shown in FIG. 12 and FIG. 13 shows that the device list creation unit 28 and the group list creation unit 29 of the server 13 are stored in the ID management DB 21 when the user presses the facility or group list display button on the terminal. Necessary information is read out from the ID management DB 21, the device information management DB 22, and the error log DB 23 using the ID or group code as a key.

    A procedure for creating such a list will be described in more detail with reference to the flowchart of FIG. When any clinical testing apparatus is connected to the server 13, the server 13 receives the ID and password of the apparatus (step S1), and confirms whether or not the received ID and password are registered in the ID management DB 21. (Step S2) If not registered, the connection is rejected (Step S3).

    If registered, the group code corresponding to the accepted password is read from the ID management DB 21 (step S4). Next, the facility name, model name, NickName, serial No. corresponding to the read group code. Are read out from the ID management information DB 21 and the device information management DB 22 to create the group list shown in FIG. 13 (step S5). However, serial no. Is not displayed. At this point, the “Status” column is blank.

    Next, the read serial number. One error date corresponding to is read from the error log DB 23, and it is confirmed whether or not the error date is within the past 48 hours (steps S6 and S7). If it is within 48 hours, the serial No. It is determined that an error has occurred within 48 hours (step S8), and there is an error, that is, an asterisk (*) is added to the "status" list in the created table of FIG. 13 (step S9).

    On the other hand, if the error date and time is before 48 hours, the read serial number. It is confirmed whether there is another error date corresponding to (step S10). If there is, the routine returns to step S6.

    Then, after adding the * mark to all devices in the list that have errors within 48 hours, add a button to the “Online QC” column of the list, Finish the creation process. The created list is displayed on the screen of the requested terminal. The table shown in FIG. 12 is created by reading the model name and the like corresponding to the ID read in step S5. Which of the tables in FIG. 12 or FIG. 13 is to be created depends on the user's selection command.

    Next, a procedure for creating an online QC report, which is another feature of the present invention, will be described with reference to the flowchart shown in FIG. The server 13 obtains the measurement result of the control sample from each clinical testing device every day (step S21), and always refers to the control information DB 25 to determine whether or not the expiration date of the control sample being used has expired (step S21). S22). When it is determined that it has expired, the online QC report creation unit 33 calculates a further necessary statistical value based on the QC measurement value shown in FIG. 7 and creates a statistical value table (step S23).

    The created statistical value table is stored in the statistical value DB 26 (step S24). The online QC report creation unit 33 creates an online QC report as shown in FIG. 11 based on the stored statistical value table and the information in the ID management DB 21, the device information management DB 22, and the control information DB 25 (step S25). And stored in the QC report DB 27 (step S26).

  Then, an online QC report is distributed to the user in response to a request from the user (step S27). An example of the online QC report shown in FIG. 11 is a report on the clinical examination apparatus 1 addressed to the hospital A, and the aggregation target period is two days of November 9 and 10 (this is the apparatus 1). Indicates that the control sample was measured only twice on November 9 and 10 within the expiration date of the control sample). In addition, the table of FIG. 11 can also be shown as a graph.

    Further, in the table for each measurement item (RBC, PLT, WBC) in FIG. 11, YourData represents the measured value of the control sample of the user's device, here, the clinical testing device 1. Group Mean represents the average of the measured values of the control sample by all registered clinical test apparatuses (here, apparatuses 1, 2, 3, 7, 8, and 9). Group SD represents the standard deviation of the measured values of control specimens from all registered clinical laboratory equipment. Group SDI represents (Your Data-Group Mean) / Group SD.

    Group N represents the number of all registered clinical laboratory equipment (excluding standard clinical laboratory equipment). Reference G represents the measured value (reference value) of the control sample by the reference clinical laboratory apparatus (in this case, the apparatus 14). Lot Average represents an average of measurement values, average values, standard deviations, etc. acquired every day. As described above, by operating the clinical test system, the user can easily obtain the quality control information for each production lot of the control sample.

1 is an overall configuration diagram of a clinical examination system of the present invention. It is a block diagram which shows the internal structure of the server which concerns on this invention. It is a block diagram which shows the structure of the clinical test | inspection apparatus based on this invention. It is explanatory drawing which shows the information stored in the server which concerns on this invention. It is explanatory drawing which shows the information stored in the server which concerns on this invention. It is explanatory drawing which shows the information stored in the server which concerns on this invention. It is explanatory drawing which shows the information stored in the server which concerns on this invention. It is explanatory drawing of the information transmitted to the server from the clinical test apparatus based on this invention. It is explanatory drawing which shows the information stored in the server which concerns on this invention. It is explanatory drawing which shows the information stored in the server which concerns on this invention. It is explanatory drawing which shows the online QC report which concerns on this invention. It is explanatory drawing which shows the apparatus list which concerns on this invention. It is explanatory drawing which shows the group list which concerns on this invention. It is a flowchart which shows operation | movement of the server which concerns on this invention. It is a flowchart which shows operation | movement of the server which concerns on this invention.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Clinical testing apparatus 2 Clinical testing apparatus 3 Clinical testing apparatus 4 Terminal 5 Terminal 6 Terminal 7 Clinical testing apparatus 8 Clinical testing apparatus 9 Clinical testing apparatus 10 Terminal 11 Terminal 12 Terminal 13 Server 14 Clinical testing apparatus 15 Terminal 16 Hub 17 Hub 18 Hub 19 Hub NW network

Claims (8)

A clinical testing system server connected to a plurality of clinical testing apparatuses installed at a plurality of facilities of one group and attached with terminals via a network,
An interface for communicating with each clinical testing apparatus via a network;
Storage means for storing an ID for specifying a facility and a group code for specifying a group as attributes of a clinical testing apparatus, and storing information for specifying a clinical testing apparatus;
Measurement result storage means for storing the measurement result of the quality control sample received from each clinical testing apparatus via the interface, the type information and the production lot information of the quality control sample;
Quality control sample information storage means for storing quality control sample type information, production lot information and expiration date;
The expiration date of the quality control sample used for the measurement result received from the expiration date stored in the quality control sample information storage means based on the quality control sample type information and the production lot information received from the clinical testing device Determining means for determining whether or not the
When the determination means determines that the expiration date of the sample for quality control has expired, the group to which the clinical test apparatus belongs is identified from the group code stored in the storage means based on the information specifying the clinical test apparatus, and this accuracy List creation means for summing up measurement results of management samples and measurement results of each clinical laboratory device belonging to the group read from the measurement result storage means, and creating a summary list for comparing the measurement results with the summary results And a clinical laboratory system server. 2. The measurement result storage unit stores measurement items of a quality control sample received from each clinical testing apparatus via an interface, and the list creation unit creates the summary list for each measurement item. The server for the clinical laboratory system described. The clinical examination system server according to claim 1, further comprising a distribution unit configured to distribute the aggregation list to the terminal in response to a request. The clinical test system server according to any one of claims 1 to 3, wherein a total result of measurement results of the clinical test apparatuses belonging to the group includes an average of the measurement results. The clinical test system server according to any one of claims 1 to 4, wherein a total result of the measurement results of each clinical test apparatus belonging to the group includes a standard deviation of each of the measurement results. A clinical laboratory system comprising the clinical laboratory apparatus connected to the server according to any one of claims 1 to 5 via a network. A clinical laboratory system server connected to a plurality of clinical laboratory apparatuses and reference clinical laboratory apparatuses, which are installed in a plurality of facilities of one group and provided with terminals, via a network,
An interface for communicating with each clinical testing apparatus via a network;
Storage means for storing an ID for specifying a facility and a group code for specifying a group as attributes of a clinical testing apparatus, and storing information for specifying a clinical testing apparatus;
Measurement results of quality control samples received from each clinical testing device via the interface, type information and manufacturing lot information of quality control samples, and measurement of quality control samples received from the standard clinical testing device via the interface Results, measurement result storage means for storing quality control specimen type information and production lot information;
The expiration date of the quality control sample used for the measurement result received from the expiration date stored in the quality control sample information storage means based on the quality control sample type information and the production lot information received from the clinical testing device Determining means for determining whether or not the
When the determination means determines that the expiration date of the sample for quality control has expired, the group to which the clinical test apparatus belongs is identified from the group code stored in the storage means based on the information specifying the clinical test apparatus, and this accuracy To aggregate the measurement results of the management specimen and the measurement results of each clinical laboratory device belonging to the group read from the measurement result storage means, and to compare the measurement results with the measurement results from the reference clinical laboratory device A clinical test system server comprising: a list creation means for creating a summary list. A clinical examination system comprising the clinical examination apparatus and a reference clinical examination apparatus connected to the server according to claim 7 via a network.

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