JP7224153B2 - External quality control method - Google Patents

Description

The present invention relates to external quality control of an automatic analyzer for analyzing blood and other bodily fluids. In more detail, when the quality control of whether the automated analyzer analyzes and measures samples correctly is performed by an external management organization different from the facility where the automated analyzer is located, The present invention relates to an external quality control data providing method for providing data for quality control and an external quality control method.

BACKGROUND ART In recent years, clinical examinations have been performed in order to accurately recognize the condition of a patient or an injury or illness and to make an accurate medical diagnosis. Automated analyzers are known as devices for biochemically or immunologically analyzing specimens such as blood and various body fluids, or for electrically analyzing specimens based on their electrical characteristics. It is

This automatic analyzer (hereinafter simply referred to as the "analyzer") is installed in a medical institution, testing institution, or testing facility (hereinafter referred to as the "testing facility" or simply the "facility" as appropriate), and the analyzer is Examinations required for diagnosis and the like are performed using this method. Also, accurate diagnosis requires highly reliable test results. For this reason, quality control of the analyzer is performed in order to manage the state of the analyzer itself. Quality control is performed by analyzing using a standard sample (or appropriately referred to as "quality control sample"), tabulating the results, and managing the tabulated data by statistical processing. There are two types of this quality control: "internal quality control", which is performed periodically inside the testing facility such as a hospital where an automatic analyzer is installed, and the analysis results using standard samples from multiple facilities are aggregated. There is also “external accuracy control” in which various statistical processing is performed to control the accuracy of equipment in multiple facilities.

In Cited Document 1, when an output error of an automatic analyzer occurs in a facility where automatic analysis is performed, the burden on the operator of the automatic analyzer is reduced, the operator's operation error is prevented, and "internal accuracy An automatic analyzer and method for processing analysis results are disclosed.
Cited Document 2 discloses various control methods for "internal quality control" and "external quality control". As an example of "external quality control", the measurement data obtained by measuring the quality control sample at the facility is collected by an external server, the collected measurement data is aggregated, and the average of the measurement data is used as statistical data related to quality control. An accuracy control method for obtaining various statistical data such as values and standard deviations and distributing the results to each facility is disclosed.

JP 2000-221198 JP 2007-286071

Patent document 1 relates to "internal quality control" in a testing facility, and aims to prevent errors in judgment of measurement results and operational errors in response processing by reducing the burden on operators in the testing facility. is. For this reason, in the analysis apparatus of Patent Document 1, when various types of error processing such as sample shortage and sample expiration occur during the analysis of an individual contracted sample, the error state and analysis values are ruled so that the operator can easily understand. Although it is displayed on the monitor, it is not included in the output data such as printed data submitted to the inspection / analysis request party under certain rules. Regarding the "internal quality control" of the device, predetermined errors in the process of analyzing standard samples are not registered as data for internal quality control and are not used in calculation data for obtaining statistical values. As described above, Patent Literature 1 discloses an invention for suppressing operation errors of operators in a facility and for solving problems associated with the "internal quality control".

On the other hand, Patent Literature 2 discloses a quality control method for collecting measurement data from a plurality of inspection facilities by a management server and performing "external quality control". The external quality control method of Patent Document 2 collects measurement data of standard samples sent from each testing facility in a management server, performs an error check on the collected measurement data, and performs measurements determined to be abnormal by the error check. Various statistical processing is performed on external quality control data by excluding data. That is, the collected measurement data for quality control is checked for errors in the management server. All measurement data including error data is transmitted or delivered from each inspection facility to the management server. As described above, Patent Document 2 discloses a technique for performing external quality control by collecting all information including measurement data determined to be erroneous in a management server. This enables statistical processing and analysis for more detailed external quality control including error information on the management server side.

However, in the external quality control method of Patent Document 2, when the number of testing facilities subject to external quality control increases and the number of analyzers managed by the management server increases, the amount of measurement data of each analyzer becomes enormous. become a thing. When the amount of measurement data of standard samples from each testing facility for quality control increases in this way, not only the communication load of the line when data is transmitted using the network but also the transmission/reception processing load of the management server increases. . In addition, because the amount of measurement data to be statistically processed is large, there is a burden of tabulating the measurement data of standard samples, checking and judging various errors as to whether or not the prescribed rules are met, and processing statistical data. Since the computational processing load for creation increases, it takes a long time for the management server to perform these processes.

The present invention has been made in view of the problems of the prior art. It is an object of the present invention to provide a method of providing data for external quality control and an efficient external quality control method that can reduce the load of collecting measurement data on a server and the computational load of error checking and statistical processing on a management server. do.

For this reason, a method for transmitting external quality control data according to a first embodiment of the present invention provides a testing facility equipped with one or more analyzers that measure specimens or quality control samples and output measurement data, wherein the accuracy An external device that sends the measurement data of the external quality control sample and its related data to a management server that generates external quality control information by aggregating the measurement data of the control sample and related data and performing predetermined statistical processing A method for sending quality control data,
At each of the plurality of testing facilities connected to the management server,
(i) using each of the analyzers to measure the quality control sample;
(ii) determining whether the measurement data measured by the analyzer conforms to a predetermined standard;
(iii) in step (ii), the measurement data and related data that do not meet the predetermined criteria are not sent to the management server, and the measurement data and related data that meet the predetermined criteria are transmitted to the external device; a step of transmitting to the management server as data for management;
characterized by comprising

Here, the predetermined criterion is, for example, a "cutoff value" or "threshold value" that causes an error in the measurement data when the measurement data does not reach a predetermined threshold value, or an expiration date of the reagent. These are various criteria for judging whether or not the sample has been correctly measured. This predetermined condition also applies to the following other embodiments.
According to the data transmission method for external quality control according to this embodiment, only appropriate measurement data required for external quality control is provided from each testing facility or analyzer to the management server, and inappropriate samples such as expired samples are Information related to measurement errors, such as measurement data using reagents, abnormal data, etc., is not sent to the management server. Therefore, in the management server that performs external accuracy control, in addition to eliminating the need for processing such as error inspection as in the past, wasteful data accumulation such as error measurement data and arithmetic processing for statistical processing etc. are unnecessary. Become. In particular, as the number of analyzers subject to external quality control increases, the amount of measurement data and related data to be handled increases. Processing and arithmetic processing loads can be reduced, and rapid arithmetic processing and immediate responsiveness are improved.

Further, in the method of transmitting data for external quality control according to another embodiment of the present invention, the predetermined standard may be a common standard used in each testing facility or each analyzer connected to the management server. can. As a result, the error judgment criteria for the measurement data of the external quality control samples provided from each testing facility or analysis device are unified, and consistent external quality control without variation becomes possible.
Also, this predetermined standard can be a standard for external quality control different from the standard used for internal quality control. As a result, it is possible to adopt a common standard for external quality control while adopting a standard suitable for the characteristics of each facility for the internal quality control of each testing facility, thereby achieving overall consistency.

The external quality control method for an analyzer according to the first embodiment of the present invention is a testing facility equipped with one or more analyzers that measure a sample or quality control sample and outputs measurement data, or via a network with the analyzer. The measurement data and related data from the testing facility or the analysis device are acquired and aggregated, and statistical processing is performed to calculate predetermined statistical information, and the statistical information is used as external quality control information. An external quality control method for an analyzer comprising a management server that sends to each inspection facility as
At each of the plurality of testing facilities connected to the management server,
(i) using each of the analyzers to measure the quality control sample;
(ii) determining the measurement data of the quality control sample based on a predetermined standard in the analyzer;
(iii) based on the determination result, transmitting only the measurement data satisfying the predetermined criteria and information related to the measurement data to the management server;
(iv) In the management server, the measurement data and the related data received from the testing facility or the analysis device are aggregated without inspection as to whether or not they conform to a predetermined standard, and the aggregated measurement data is and a step of generating statistical information or external quality control information by performing statistical processing based on the information.

According to the external quality control method according to this embodiment, the management server eliminates the need for checking whether the measurement data or related data received from each testing facility or analysis device conforms to a predetermined standard, that is, checking for errors. Become. Therefore, the load on the management server is reduced.
In addition, since the amount of data to be transmitted such as measurement data is also reduced, the load on the communication line, the load of the communication processing of the management server, the totalization load, and the calculation load of the statistical processing are also reduced.

Further, according to the external quality control method according to another embodiment of the present invention, the predetermined standard for judging the measurement data is set as a standard for external quality control different from the standard used for internal quality control. can do. It is also possible to receive this predetermined criterion from the management server. Further, the management server updates the predetermined criteria appropriately based on the data obtained by tabulating and statistically processing the measurement data received from each testing facility or analysis device, and transmits the data to each analysis device or testing facility. can also be configured to

In this way, by using different predetermined standards for internal quality control and external quality control, internal quality control according to the characteristics of each testing facility or analyzer, and consistency of statistical data between each testing facility in external quality control It is possible to appropriately deal with the conflicting issue of maintaining sexuality according to the characteristics and circumstances of each testing facility.
In addition, the predetermined criteria used for judgment of each inspection device or analysis device shall be set as a common standard for each analysis device or each inspection facility connected to the management server and subject to external quality control, and shall be updated based on measurement data, etc. Therefore, it is possible to suppress variations in measurement data among inspection facilities.

An external quality control method for an analyzer according to another embodiment of the present invention is connected via a network to a testing facility or analyzer equipped with one or more analyzers that measure specimens or quality control samples and output measurement data. and a management server for inputting and aggregating the measurement data and related data from the analysis device and executing predetermined statistical processing to create external quality control information. There is
(i) a step of sending all measurement data obtained by measuring the quality control sample in the analysis device and related data from the analysis device or the testing facility to the management server;
(ii) determining in the management server whether the measurement data of the quality control sample received from the analysis device or the testing facility and its related data conform to a predetermined standard;
(iii) Based on the determination result in step (ii), the management server displays a normal value or an error value depending on whether the measurement data or the related data conforms to the predetermined criteria. a step of assigning and totalizing and storing;
(iv) calculating statistical information of the obtained measurement data of the quality control sample and its related data in the management server, using only the analysis data determined to be normal values;
characterized by comprising

According to the external quality control method according to this embodiment, the measurement data and related data from each testing facility or each analysis device are all sent to the management server regardless of whether or not they conform to the predetermined criteria, and are aggregated by the management server. and stored. On the other hand, in the management server, it is checked whether it conforms to the predetermined criteria, and error data, abnormal data, etc. are excluded from the data subject to statistical processing for external quality control. It is possible to reduce the computational processing load of the server.

In this embodiment, it is also possible to update the predetermined criteria used for error checking and the like based on the measurement data and related data totaled and statistical information by the management server. This allows the predetermined criteria to be sequentially updated to the latest values.

According to the first embodiment of the present invention, each inspection facility or each analysis device inspects whether or not the predetermined conditions are met. , there is no need to perform an error check such as whether or not a predetermined standard is met. Therefore, the load on the management server such as error checking is reduced. In addition, when the measurement data or related data is transmitted from each analysis device or each inspection facility to the management server via the communication network, the measurement data corresponding to the error value and related data are not transmitted. The load on the communication line and the load on the communication processing of the management server can be reduced, and the load on counting measurement data and the like and the computation load for statistical processing can also be reduced.

It is a conceptual diagram of the automatic analyzer of each inspection facility. 1 is a conceptual diagram showing the overall concept of the present invention; FIG. 4 is a flow chart showing the flow of control in the first embodiment; FIG. FIG. 11 is a flow chart showing the control flow of the second embodiment; FIG. 11 is a flow diagram showing the control flow of the third embodiment;

The present invention relates to external quality control that collects standard sample measurement data and related data (hereinafter simply referred to as "measurement data") from a plurality of inspection facilities or inspection institutions equipped with automatic analyzers and performs statistical processing. It is. In particular, measurement data from many inspection facilities or analysis equipment are concentrated, and external accuracy control can be performed by reducing the load of aggregation and data calculation processing on the management server, which needs to perform a huge amount of calculation. It was made with a focus on doing it efficiently. Automatic analyzers include various devices that biochemically or immunologically analyze specimens such as blood and various body fluids, or electrically analyze specimens based on their electrical characteristics.

Various embodiments of the external quality control method of the present invention will be described below with reference to the drawings. In addition, the same reference numerals are attached to the constituent elements that are common in the drawings. Also, it should be noted that components depicted in one drawing may be omitted in another drawing for convenience of explanation. Furthermore, it should be noted that the attached drawings are not necessarily drawn to scale.

(Example of sample measurement using an automated analyzer)
FIG. 1 shows an example of an automatic analyzer 100 (hereinafter referred to as "analyzer 100") installed in each testing facility. Each laboratory has one or more such analyzers 100 . Although the example of FIG. 1 shows an example in which the analyzer 100 is directly connected to the management server 205 via a communication network 135 such as the Internet, one or more analyzers 100 are connected to a server in the laboratory. (not shown) and may be connected to the management server 205 via the communication network 135 .

The analysis apparatus 100 illustrated in FIG. 1 includes an analysis section 120 , a control section 131 , an input/output section 132 , a storage section 133 and a communication section 134 . The analysis unit 120 includes a sample container 101, a sample container 102 containing a sample, and a reagent tray 103 rotatable in the direction of arrow A while holding various reagent containers 104, each of which contains reagents necessary for a test item. A reagent container 104, a light source 105 used for optical measurement, a reaction container 106, a photodetector 107 for obtaining data for optically measuring the amount and generation rate of a reaction product using a colorimetric method or the like, and a sample. It includes a nozzle arm 109 , a sample nozzle arm driving section 110 , a reagent nozzle arm 112 and a reagent nozzle arm driving section 113 .

A sample nozzle 108 and a reagent nozzle 111 are provided on the sample nozzle arm 109 and the reagent nozzle arm 112, respectively. 1, the specimen nozzle arm 109 and the reagent nozzle arm 112 are moved in the direction of arrow B by the specimen nozzle arm driving section 112 and the reagent nozzle arm driving section 113 so as to change their horizontal angles, respectively. Alternatively, it is rotatable in the A direction and, although not shown, is also movable in the vertical direction.
The analyzer 100 also has a transport mechanism (not shown), which can move a desired sample container 102 from the sample container 101 to the sample aspiration position (the position of the sample nozzle arm 109 in FIG. 1) (sample When the container 102 moves, the sample nozzle arm 109 moves upward, and the sample container 102 and the sample nozzle 108 do not interfere).

With this structure, a desired specimen and a desired reagent can be injected into the reaction container 106 by the following procedure. First, the sample container 102 to be measured is moved to the sample aspirating position, the sample in the sample container 102 is aspirated by the sample nozzle 108, and the sample nozzle arm 109 is rotationally moved above the reaction container 106 to aspirate. A sample to be tested is discharged into the reaction container 106 . Next, after the tray 103 is driven to rotate and the reagent nozzle 111 aspirates the reagent from the desired reagent container 104, the reagent nozzle arm 112 is driven to rotate and the reagent aspirated from the reagent nozzle 111 is discharged into the reaction container 106. be done. A reaction product generated by reacting the sample and the reagent in the reaction container 106 under a predetermined environment for a predetermined time is detected by the light source 105 and the photodetector 107 . These detection data are transmitted to the control unit 131, and the amount and generation rate of the reaction product are measured and analyzed by measurement/analysis software, etc., which will be described later.

The input/output unit 132 includes an input device for data input from an operator (typically a keyboard or mouse), an input device for reading barcodes, etc., and a monitor or printer for outputting the control state of the analyzer, measurement results, and the like. It is equipped with various output devices such as The storage unit 133 typically includes a memory such as ROM and RAM, a hard disk, and the like, and stores control programs and various application programs for controlling the operation of the analyzer and each unit, as well as judgment rules and other information. The communication unit 134 stores data such as inspection and measurement results, internal management information, and the like, and transmits and receives data to and from the external inspection facility such as the management server 205 or other units within the inspection facility. The control unit 131 controls the operation of each unit in the analysis apparatus 100, input/output control, storage control, communication control, etc., and various predetermined functions using control software and application programs stored in the CPU, the storage unit 133, and the like. Arithmetic processing, etc. are performed.

Next, the basic operation of the analyzer 100 will be described with an example. The operation of the analyzer 100 is controlled by the controller 131 . The control unit 131 includes a CPU and control software, and based on a procedure instructed by a predetermined application program (measurement/analysis software, etc.) according to the purpose, such as acquisition of measurement data for external quality control, predetermined It controls the operation of the analyzer 100 to perform the operations.

When inspecting or measuring a sample, for example, first, a sample container 102 containing a sample to be inspected is selected from the sample container 101, and the selected sample container 102 is aspirated by a transport mechanism (not shown). moved to a position. Next, the sample nozzle arm 109 is moved to the sample aspirating position (the position indicated by the solid line) by the sample nozzle arm driving section 110 and then lowered to move the sample nozzle 108 from the sample container 102 placed at the sample aspirating position to the required sample nozzle 108 . A volume of specimen is aspirated.

Subsequently, the sample nozzle arm 109 is moved onto the reaction container 106 arranged at the reaction position, and the sample sucked by the sample nozzle 108 is discharged into the reaction container 106 . After that, the sample nozzle arm 109 is moved to the standby position, and the sample nozzle 108 is cleaned in preparation for the next test (not shown).

Measurement of a standard sample (quality control sample) for internal quality control and external quality control is also placed in the sample container 102 and set in the sample storage unit 101 in the same manner as the sample inspection. The quality control sample is moved to the sample aspirating position for measurement periodically or at a predetermined timing, is aspirated by the sample nozzle 108 and is discharged into the reaction container 106 . In the following description, quality control samples and specimens are not distinguished from each other, and both are referred to as specimens, unless otherwise necessary.

Next, the reagent tray 103 is rotated to move the reagent container 104 containing the target reagent to a predetermined reagent aspirating position. Next, the reagent nozzle arm 112 is moved to the reagent aspirating position (in the direction of arrow C) by the reagent nozzle arm driver 113, and the required amount of reagent is aspirated by the reagent nozzle 111 from the reagent container 104 arranged at the reagent aspirating position. . Subsequently, the reagent nozzle arm 112 is placed on the reaction container 106 placed at a predetermined position, and the reagent sucked from the reagent nozzle 111 is discharged into the reaction container 106 . Subsequently, the reagent nozzle arm 112 is moved to the standby position, and the reagent nozzle 111 is cleaned (not shown) in preparation for the next inspection/measurement.

The sample and reagent added to the reaction container 106 are stirred by a stirring mechanism (not shown). A temperature control mechanism (not shown) causes a reaction at a predetermined temperature for a required time, and optical measurement is performed after the predetermined time has elapsed. In the optical measurement, the reaction vessel is irradiated with light of a required wavelength from the light source 105 as indicated by an arrow D. Transmitted light or scattered light of the irradiated light is detected by the photodetector 107 as an amount of electrical information. The detected amount of electrical information is transmitted to the control unit 131, and the measurement/analysis software installed in the control unit 131 converts it into a measurement value (measurement data) according to a predetermined conversion table or conversion rule. is converted to In the following, the measurement results obtained after the reagents are added and other processes based on the predetermined procedure, the measurement results of the analyzer, the test results, or the like are simply referred to as "measurement values" or "measurement data."

The measurement data is stored in the storage unit 133, and various analyzes are performed according to the inspection items. Also, after the measurement is completed, the reaction container is discarded, and a new reaction container is placed at the reaction position for the next measurement. Measured data stored in the storage unit 133 in response to an instruction from an operator by input means, a periodic instruction by a program, or a request from the management server 205 is transmitted via a recording medium output from the input/output unit 132 or by communication. It is delivered to the management server 205 or the like via the unit 134 by mail, facsimile, or via the communication network 135 or the like.

(Internal accuracy control)
The operator of each facility uses the analyzer to measure the next quality control sample at predetermined measurement intervals, for example, every 100 samples after the first quality control sample is measured. From the measured data of the quality control samples, various statistical data such as intraday and daily differences, average values of each, and standard deviation (SD) are periodically calculated. Here, intraday means state management of the analyzer on each measurement day, and daily difference means state management of the analyzer for each measurement day. For example, if the measured value of the quality control sample does not fall within the range of the average ± (2 x standard deviation, 3 x standard deviation, etc.), an alarm is generated to alert the operator. Calculation results such as measurement average values obtained from quality control are output as intra-day quality control results or daily difference quality control results.

Note that FIG. 1 shows a configuration example in which communication functions and measurement data are recorded in the analysis device 100, but if there are multiple automatic analysis devices 100 in one facility, the measurement data from each analysis device 100 is received by a management device (not shown) in the facility and transmitted to the external management server 205 via the management device.

(External quality control)
The measurement data of quality control samples are used for internal quality control and also as data for external quality control. A management device (management server 205) installed in a customer service center (CS center) 204 stores the measurement data of quality control samples measured by each analyzer in each facility for each model of analyzer and type of quality control sample. , or according to parameters such as each region and each date and time of measurement. Aggregate the collected measurement data as a whole and aggregate it by classification, obtain and store the average value and standard deviation of the measurement data as statistics related to quality control, and provide the aggregated results to participating institutions as external quality control do.

Data exchange with the CS center 204 that collects measurement data from the analysis device 100 and performs statistical processing will be described below as an embodiment of the present invention with reference to the drawings. FIG. 2 is a diagram for explaining the concept of external quality control of the present invention, and FIGS. 3 to 5 outline the processing procedures of various embodiments of basic data processing for external quality control in the present invention. FIG. 4 is an exemplary flow diagram; The quality control system of the present invention is mainly intended for biochemical tests, immunoserological tests, blood coagulation tests, and bacteriological tests. It can be applied to systems on many communication networks in need. It can also be applied to an analyzer that measures electrical properties of a sample.

Using FIG. 2, an overall overview of the internal quality control operation and the transmission and reception of various data between each facility for external quality control according to the present invention and the CS center 204 will be described. For example, the expiration date and other information related to the quality control sample is obtained by inputting from the input/output unit 132 or by reading a bar code attached to the quality control sample. The measurement of the quality control sample can be arbitrarily set, such as before and after the start of the test every day, during the test, every predetermined number of specimens, or every predetermined time. The measurement data of the quality control sample acquired based on the output from the analysis unit 120 is recorded in the storage unit 133 in association with the quality control sample. Various statistical data such as an average value, a measurement range, a standard deviation, and a coefficient of variation are calculated from the measured data by a control unit 131 having an arithmetic function such as a CPU. The type of statistical data to be calculated here can be freely set. The measured data and the calculated statistical data are accumulated in the storage unit 132 and integrated with the previously measured and aggregated measured data and statistical data. Based on these measurement data and statistical data, it is possible to create control charts for the facility as internal quality control materials.

In addition, the control unit 131 compares the predetermined judgment value input from the input/output unit 132 with the numerical value of the statistical material calculated based on the measurement data, determines the presence or absence of the variation and the cause thereof, and determines the presence or absence of the variation. You can also output from Information/data necessary for such determination and rules for determination can be stored in the storage unit 133 as application programs and data for determination, and can be executed by the control unit 131 as a determination function. The information and data necessary for such determination are inputted in advance by the operator and stored, or received from the external CS center 204 and stored, or these information are used as the result of arithmetic processing with the measured values. These data can be used with modification according to the requirements. These stored measurement data, aggregated results, and control charts are saved as internal quality control information, and displayed on a monitor or printed out for use by inspection operators.

Next, the cooperation between each facility or analysis device and the CS center (for example, a management center that performs tabulation processing for each participating facility) will be described. As shown in FIG. 2, external quality control includes a group of testing facilities 201 consisting of testing facilities such as medical institutions 202 and testing institutions 203 that participate in external quality control, and a CS including a management server 205 with aggregating function, database function, etc. It consists of a center 204 . Measured data from the inspection facility group 201 is sent (206) by a wide-area information transmission tool using hand delivery by a delivery person, mail, telephone line, FAX, e-mail, data communication, etc. received at. Considering the real-time nature of the wide-area information transmission tool, it is preferable to use the Internet, and furthermore, to use a point-to-point dedicated line service connecting two bases.

Distribution (208) of the aggregated results/evaluation reports of external quality control information statistically processed by the CS center 204 to each testing facility can also be performed using a wide-area information transmission tool. does not have to be the same method as On the other hand, transmission/reception 207 of control data transmitted/received between each inspection facility group 201 and the management server 205 is preferably performed in real time through a communication network.

Processing procedures for external quality control according to the present invention will be described below with reference to FIGS. 3 to 6. FIG.
In the following description, in order to distinguish each processing procedure from one embodiment to another, different numbers are assigned to the inspection facilities or analyzers and CS centers that execute the respective processing procedures according to each embodiment. (Also different from the numbers used in FIG. 2).

<Embodiment 1>
A processing procedure of an embodiment of a method for providing external quality control data according to the present invention will be described with reference to FIG. 3 and specific data transmission examples. In each analyzer in each testing facility 300, the quality control sample is measured (S301: hereinafter, the number with S indicates the number of each step), and then the measurement data of the measured quality control sample are aggregated (S302). Aggregated measurement data will be used as internal quality control data and external quality control data. After that, the aggregated measurement data is evaluated and selected based on a predetermined standard (S303), and only the measurement data exceeding the predetermined standard value is sent to the CS center 310 as the measurement data for external quality control (S304).

Here, the predetermined criteria for evaluating the measurement data may be set independently by each facility, but statistical materials that are consistent among the inspection facilities 300 participating in the external quality control are created. For this reason, it is preferable to use a common standard for external quality control. In this case, the measurement data may be evaluated and selected based on different criteria for internal quality control and external quality control to determine whether or not there is an error. It is also possible to weight the reference value and evaluate the measurement data using the weighted reference value. At this time, each laboratory weights its own different standard values, performs an internal accuracy check based on each laboratory's own weights, and based on the standard values with common weights for each laboratory The measurement data to be sent to the CS center 310 may be selected by judging whether or not there is an error. In the following description, regardless of whether the reference value is weighted or not, it will simply be referred to as the "reference value." Similar weighting can be performed in other embodiments described below.

For external quality control, quality control is performed as a whole for the analyzers of many facilities. For example, if the installation locations of analyzers subject to external quality control are far apart, such as between Kyushu and Hokkaido, the temperature, humidity, and other natural environments differ greatly. In addition, the storage conditions and management equipment for standard samples (quality control samples) and various reagents differ among facilities, and the management environment and management methods for quality control samples, reagents, etc. also vary. Such a difference in management environment for reagents and the like also affects measurement data of quality control samples. Therefore, in order to maintain uniform testing accuracy at each facility, the values (threshold values, etc.) that serve as the criteria for error judgment in individual internal quality control for each facility (or analyzer) must be adjusted according to the environmental characteristics of each facility. It is desirable to set relatively strict standards that are consistent.

On the other hand, in external quality control, since a plurality of facilities or analyzers to be managed are commonly managed, it is desirable that all facilities use a common standard for error determination in external quality control. However, as mentioned above, there are regional differences and differences in the management environment in the upper and lower limits for judging errors in measurement data. , If the reference values (upper and lower limits) for error judgment are strictly defined, due to the influence of environmental differences, measurement data of a certain facility may be judged as an error even though it is not an error, or where it should be judged as an error. It is possible that it is determined that there is no error. In order to avoid such a situation, it is desirable that the criteria for external quality control be different from those for internal quality control.

The CS center 310 aggregates and records the measurement data received from each testing facility 300, and statistically processes the aggregated measurement data to create external quality control data (external quality control information). The external quality control data is fed back to each testing facility 300 and used to determine reference data and diagnostic information for internal quality control.

In each inspection facility 300, in the evaluation selection process (S303), the acquired measurement data is compared with the predetermined reference value (threshold value) of each facility and the recorded information, and the value (error values) are actualized and sorted according to predetermined rules. At this stage, the expiration date of quality control samples, abnormal lot numbers, and measurement data designated as errors by the operator are also sorted out and stored in the storage unit as data for internal quality control along with normal measurement data. .

Next, the measurement data obtained by excluding the measurement data with predetermined conditions from the measurement data having these error values and the normal measurement data are sent to the CS center 310 using the wide area information transmission tool (S304, arrow E ). The timing of transmission to the CS center 310 can be arbitrarily set, such as at regular intervals, when the number of measurements exceeds a certain number, or for each subject. Further, the measurement of the quality control sample and transmission to the external CS center may be automatically performed, or a step may be added to confirm with the administrator of the analyzer whether transmission is possible or not at the time of transmission.

The CS center 310 aggregates and records the received measurement data together with the measurement data of quality control samples received from other facilities (S311). Next, statistical processing (computation) is performed based on the measurement data received from each inspection facility and aggregated, and various data for external quality control are created and recorded (step 312). Subsequently, the statistically processed external quality control data is sent to each inspection facility (step 313, arrow F). Each laboratory receives and records these external quality control data (S305). These external quality control data are presented to facility administrators, administrators of analyzers, users, and other concerned parties, and are used for quality control of each analyzer.

Various data sent from each testing facility to the CS center in the quality control method according to the prior art and the external quality control method according to various embodiments of the present invention will be compared and explained below. In the following comparative examples, the threshold for normal values of measurement data in each testing facility is set to 50 or less, and the normal lot number is set to 100-120.

これらの測定データ中、番号4の測定データは試薬品の有効期限が過ぎ、測定データも閾値を超えておりかつロット番号違反でもある。番号５の測定データは測定データが閾値を超えている。しかし、従来の外部精度管理方法では、これらの有効期限切れ、ロット番号違反等の測定データも、分析装置からＣＳセンタ３０１に送出されていた。 Table 1 shows an example of measurement data and related data transmitted from each testing facility or analyzer to the CS center 310 in the conventional external quality control method.

Among these measurement data, the measurement data of number 4 is past the expiration date of the reagent, the measurement data also exceeds the threshold value, and is also a lot number violation. The measurement data of number 5 exceeds the threshold. However, in the conventional external quality control method, measurement data such as expiration date and lot number violation are also sent from the analyzer to the CS center 301 .

Table 2 shows an example of quality control reagent measurement data transmitted from each testing facility 300 to the CS center 310 based on one embodiment of the present invention for the same object as the measurement data illustrated in Table 1. That is, various data to be sent to the CS center after the measurement data evaluation and selection processing step (S303) are exemplified. In Table 2, the data items sent to the CS center 310 are the same as those in Table 1 in order to facilitate comparison with the data obtained by conventional external quality control. be.

In Embodiment 1 of the present invention, as shown in the example of Table 2, the information regarding measurement number 4 and measurement number 5, which are expired, lot number violations, or measurement data exceeds thresholds, are excluded from the outgoing data. , is not sent from the inspection facility 300 to the CS center 301 .
You can arbitrarily set what kind of error value should not be sent. In this first embodiment, the data of measurement numbers 4 and 5 are not sent if the expiration date has expired, the lot number is violated, or the measurement data exceeds the threshold. It is excluded from the transmission data as transmission prohibited error data.

In the first embodiment, in step 313, the measurement data aggregation result of the external quality control sample sent to the CS center 310 is used as it is to create the external quality control information. Statistical processing for external quality control may be performed after excluding error values based on the latest 3xSD value or other predetermined cutoff value.

According to the external quality control method according to the first embodiment, the amount of measurement data sent from each testing facility to the CS center 310 is reduced. Therefore, if transmission is performed through a communication line, not only is the line load reduced and the time required for transfer shortened, but also the communication processing load of the management server is reduced. Therefore, the risk of interrupt processing due to access from another testing facility while data is being received from one testing facility is reduced, and normal operation of the management server is guaranteed. In addition, the amount of computation for totalization processing and statistical processing by the management server of the CS center 301 is also reduced, making it possible to shorten the processing time and suppress the energy consumption of the management server.

<Embodiment 2>
Next, a data control method according to another embodiment of the external quality control method according to the present invention will be described with reference to FIG. A quality control sample is measured in each testing facility 400 (S401), and then measurement data of the measured quality control sample is aggregated (S402). On the other hand, at the CS center 410, cutoff values (threshold values for determining the range of measured values assumed to be normal) are set in advance at the time of system introduction and stored in the storage unit 415 of the management server. This cutoff value is transmitted in advance from the CS center 410 to each testing facility as control information (S411 and arrow G). This cut-off value is used as common reference data in the processing (S403) for evaluating and selecting whether or not to transmit the measurement data to the management server at each facility 400, and is shared by all inspection facilities 400.

The initial cutoff value stored in the storage unit 415 of the management server of the CS center 410 can be configured to be updated to the latest value each time measurement data is received from each inspection facility. For example, based on the aggregated/statistical data, which is the aggregated result of the external quality control data calculated immediately before and stored in the storage unit 415, for example, a 3xSD value (SD is the standard deviation value) is calculated, and each inspection facility 400 It is also possible to update the cut-off value used for evaluation screening and transmit it to each inspection facility 400 (S411).

Based on the cutoff value, each testing facility 400 excludes values (error values) out of the cutoff value from the aggregated results of the measurement data of the external quality control samples. In other words, in addition to evaluation and selection based on the cutoff value, error information such as the expiration date of quality control samples, abnormal lot numbers, and data excluded by the operator is stored in the storage unit of each testing facility or analyzer ( S403). Next, the measurement data summation result of the external quality control samples selected for evaluation is sent to the CS center 310 (S404: arrow H). At this time, it is determined based on a predetermined rule whether or not to transmit measurement data including error information as data for external quality control.

Here, the measurement of the external quality control sample can be freely set such that it is sent every time a certain period of time elapses, the number of times the specimen is determined, every time the specimen is measured, or according to an operator's instruction. Further, the measurement and transmission may be automatically performed, or a step may be added to confirm with the manager of the analyzer whether or not transmission is possible at the time of transmission.
Each facility 400 weights the cutoff values received from the CS center 410 in step 411 of the CS center in the evaluation and selection process in step 403, and performs evaluation and selection based on the cutoff values calculated from these weights. can also be done.

When the measurement data is received from the facility 400, the CS center 410 aggregates the received measurement data together with the measurement data of quality control samples from other testing facilities that have been stored in a database or the like, and performs statistical processing. (S412). The statistically processed data is stored in a storage unit 415 such as a database in the management server, and used to create control information such as a cutoff value (S411). Subsequently, the statistically processed external quality control information is sent to each facility (S413, arrow I) and shared by each facility 400. FIG. Each testing facility receives this information (S405), presents it to related parties such as facility managers, analyzer managers, and operators via the input/output unit, and uses it for quality control of each analyzer. .

In the processing step S401 of the second embodiment, it is assumed that measurement data as shown in Table 1 are acquired by each analysis device of each testing facility 400. These data are shown in Table 1 for each testing facility or analysis device. Such measurement data is aggregated and used as data for "internal quality control" (S402).
These measurement data are also used as data for "external quality control" as in the first embodiment. In the second embodiment, unlike in the first embodiment, measurement data sent to the CS center 410 is evaluated and determined based on cutoff values sent as control information from the CS center 410 at each testing facility 400 . Assuming that the cutoff value of the measurement data received from the CS center 410 as the control information is "50" and the normal lot number is "100-120", the measurement number 4 in the list of Table 1 is abnormal lot number, expired, and Due to the measurement data error, measurement number 5 is determined to be an error value and excluded, and only the measurement data shown in Table 2 is transmitted to the CS center 410 as in the case of the first embodiment.

In the second embodiment, in the processing step S412 of the CS center 410, the measurement data aggregation result of the external quality control sample sent from each testing facility 400 to the CS center 410 is used as it is to create the external quality control information. there is However, the external quality control data may be statistically processed after excluding error values based on the 3SD value based on the latest aggregated data in the CS center 410 or other cutoff values.

In the data control method for external quality control according to the second embodiment, as in the first embodiment, the amount of data transferred from each testing facility 400 to the CS center 410 is reduced. communication processing load is reduced. For this reason, the management server during communication is less likely to be interrupted by other inspection facilities, the load of exception processing such as interrupt processing on the management server is reduced, and management server resources can be efficiently allocated to normal operations. becomes possible. In addition, since error-related measurement data is eliminated from each inspection facility before being sent out, the amount of aggregated data at the CS center is also reduced, and the amount of computation for aggregation and statistical processing on the management server is also reduced. Also from the viewpoint of arithmetic processing, the load on the management server is reduced, the processing time is shortened, and the energy consumption of the management server is suppressed.

<Embodiment 3>
Next, a data control method according to another embodiment (embodiment 3) of the external quality control method of the present invention will be described with reference to FIG.
First, quality control samples are measured in each testing facility 500 as in the conventional case (S501), and the data of the measured quality control samples are aggregated (S502). Subsequently, the measurement data are evaluated for internal quality control (S503). After that, the measurement data is transmitted from each testing facility 500 to the CS center 510, but in the third embodiment, the measurement data acquired at the testing facility 500 is used as the measurement data in the error state without considering the evaluation in the processing step S503. All of them are sent to the CS center 510 (S504: arrow J). Here, the measurement timing or the transmission timing of the measurement data of the quality control sample can be arbitrarily set, for example, after a certain period of time has passed, after a certain number of samples have been determined, or whenever a sample is measured. be able to. The measurement and transmission may be automatically performed without the administrator's approval, or a step may be added to confirm with the administrator of the analysis device whether or not transmission is possible at the time of transmission.

On the other hand, the CS center 510 calculates control data such as a cutoff value (for example, 3SD value) based on the previously calculated latest external quality control data aggregation result (S513) (S511). It should be noted that if the measurement data at the time of introduction of the system has not been sufficiently aggregated, it is preferable to set a predetermined initial cutoff value as an offset. The measurement data received from each inspection facility 500 is judged and evaluated based on the calculated cutoff value, and the error value is aggregated in association with the dummy code and stored in the management server (S512). . Next, the CS center 410 tabulates the measurement data including the tabulated data associated with the dummy code together with the already tabulated and stored measurement data from other inspection facilities, and performs statistical processing (S513). At this time, the measurement data to which the dummy code is assigned may not be used for the statistical processing, or may be aggregated according to the type of the dummy code. Subsequently, the statistically processed external quality control information is sent to each facility (S514 arrow K).

In the third embodiment, the measurement data as illustrated in Table 1 are transmitted as they are from each testing facility 500 or analysis device (S504). The CS center 5101 receives the measurement data and performs evaluation judgment processing (S512). A dummy code is attached to the measured data after this evaluation. Table 3 shows an example of measurement data with dummy codes.

In the example of Table 3, as in Tables 1 and 2, the measurement data number, quality control sample name, quality control sample lot number and expiration date, date and time of measurement, and facility code of the analyzer are used as information related to the measurement data. , which contains error code information in addition to measurement data. In the management server, the cutoff value is 50 and the normal lot numbers are judged and selected based on the criteria of 100 to 120. Number 4 in the list in Table 1 is an error due to a lot number abnormality or measurement data error, and number 5 is an error due to a measurement data error. It is judged as a value, and a dummy code "○" is given. Conversely, a predetermined code such as "o" may be attached to the normal value. Expired reagents and the like are not usually used for measurement, but by sending them to each facility 500 with a dummy code, they can be used as internal quality control data and statistical data for internal quality control. Become.

The measurement data with the dummy code is sent to each testing facility 500, presented to the manager of each testing facility or to a person concerned, and used for internal quality control of each analyzer (S step 505).
In the third embodiment, if the measured data with dummy codes are not used for calculation of statistical processing, but only as external quality control tabulation materials, the data with dummy codes are not used for statistical processing. Since it is not used, the amount of calculation for the statistical processing of the management server is reduced, the load on the management server is reduced, the processing time is shortened, and the energy consumption of the management server can be suppressed.

According to the present invention, since there is no need to perform complicated comparison calculations each time a total is collected for external quality control of the analyzer, the evaluation of the total results and subsequent processing can be performed quickly.

100 Automatic analyzer 101 Specimen storage unit 102 Specimen container 103 Reagent tray 104 Reagent container 105 Light source 106 Reaction container 107 Photodetector 108 Specimen nozzle 109 Specimen nozzle arm 201 Facility group 202 Medical institution 203 Testing institution 204 CS center 205 Management server

Claims (5)

A test facility equipped with one or more analyzers that measure a quality control sample consisting of a sample and a standard sample for controlling measurement accuracy and outputs measurement data , or is connected to the said analyzer via a network, Predetermined statistical information is calculated by acquiring and aggregating the measurement data of the quality control sample and related data from the testing facility or the analysis device and performing statistical processing, and the statistical information is used as external quality control information for each of the above An external quality control method for an analyzer comprising a management server for sending to an inspection facility,
At each of the plurality of testing facilities connected to the management server,
(i) using each of the analyzers to measure the quality control sample to obtain the measurement data ;
(ii) in the analyzer , a determination step of determining whether or not to transmit the measurement data of the quality control sample to the management server based on a predetermined criterion ;
(iii) based on the judgment result of the judging step , a step of excluding measurement data that does not meet the predetermined criteria and transmitting only measurement data that satisfies the predetermined criteria and information related to the measurement data to the management server; and,
In the management server,
(iv) aggregating the measurement data and the related data received from the testing facility or the analysis device, and performing statistical processing based on the aggregation of the measurement data ;
(v) generating statistical information or external quality control information by the statistical processing ;
An external quality control method for an analyzer, comprising: 2. The method according to claim 1 , wherein the predetermined standard used for determination in step (ii) is a standard for external quality control different from a standard for internal quality control of the testing facility or the analyzer. external quality control method for the analyzer. Furthermore, before the step (ii) of determining the measurement data by the analysis device,
(vi) The analysis device comprises a step of receiving, from the management server, the predetermined criteria for judging the measurement data of the quality control sample in the analysis device . External quality control method for the analyzer according to 1. The management server updates the predetermined criteria based on the aggregation of the measurement data and the statistical information in the steps (iv) and (v) , and transmits the updated criteria to the testing facility or the analysis device. 4. The external quality control method for an analyzer according to claim 3 . 4. The method according to claim 3 , wherein the predetermined standard received from the management server is a common standard commonly used in each of the inspection facilities or each of the analyzers for which the management server performs external quality control. Described external quality control method.

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