JP2006064568A - Automatic external quality control system and method - Google Patents

Abstract

A system and method for automatically performing external quality control in a specimen test by communication.
An automatic external quality control system for an analyzer that uses a reagent to measure patient specimens, and periodically and automatically obtains control measurement data from analyzers arranged in a plurality of facilities for communication. Is transmitted to the central data bank using the means, the measurement data is compared with the average value of the entire system stored in the central data bank in advance by the calculating means, the deviation value is calculated, and the magnitude of the deviation value is calculated. An automatic external quality control system and an automatic external quality control method for issuing a ranked evaluation. The system and method of the present invention makes it possible to promote labor saving of inspection work.
[Selection] Figure 1

Description

  The present invention relates to an external quality control system and method for a sample analyzer. More particularly, the present invention relates to a system and method for automatically performing external quality control in a specimen test by communication.

  In general, there are internal quality control and external quality control in the quality control of the specimen test, which is carried out by measurement using control serum or the like.

  Internal accuracy control is data management within the facility. Measurement data is periodically and automatically acquired by an analyzer, and the measurement data obtained within the facility is managed and analyzed using the measurement data obtained within the facility. It manages the accuracy of the machine.

  On the other hand, external precision management aims to improve the accuracy of the analyzer by objectively recognizing the position of the measurement data by comparing the measurement data obtained in the facility with the measurement data obtained in other facilities. Is.

  External accuracy management is also included in the sample management addition newly established in accordance with the recent revision of insurance medical fees, and it contributes to standardization of sample measurement values and improvement of patient data accuracy.

  External quality control is generally performed by various external organizations and companies.

  There are various ways in which external quality control is implemented, but the data report is sent by mail or e-mail.

  That is, the control measurement data acquired by the analyzer disposed in each facility is transmitted to the central data processing facility by mail or e-mail, and the data is stored and managed in the central data processing facility. Such intensive data management reduces errors between facilities and contributes to improvement of data measurement accuracy.

  However, such intensive data management requires re-entry of the transmitted measurement data to the central data bank, which requires enormous labor and time for data storage and management. Moreover, it is necessary to arrange a special engineer in each facility where the analyzer is arranged in order to analyze and transmit the control data. Furthermore, since data is normally input manually, human input errors are likely to occur.

  In addition, such conventional centralized data management measures control data with analyzers installed in each facility, transmits the measurement data to the central processing facility, and calculates it at the central processing facility. It takes at least a few days to reply to each facility. Therefore, if it becomes clear from the analysis of the central processing facility that the measurement accuracy of the analyzer is out of the specified range, the sample measurement performed during that time will be inaccurate, and you will not have to perform these sample measurements again. Must not.

  Furthermore, analysis and transmission of the control data of the analyzers in each facility is basically left to the engineers in charge at each facility, so if the engineer in charge does not perform analysis and transmission for some reason, analysis The measurement accuracy of the machine remains unclear.

  The present invention is intended to solve the above-described problems, and promotes labor saving in inspection work by providing an automatic external accuracy management system that automatically transmits and acquires control data via a telephone line or the like.

  Another object of the present invention is to quickly measure control data, compare it with data from other analyzers, and return results, resulting in poor measurement equipment or unacceptable deviations in accuracy, and unclear accuracy. It is to prevent the specimen test measurement in the state.

  Furthermore, another object of the present invention is to greatly improve the efficiency and accuracy of control data measurement of a plurality of analyzers by centrally managing measurement data from a plurality of analyzers arranged in a plurality of facilities. That is.

  The purpose is to improve the service to patients by promoting the introduction of tests in small and medium-sized hospitals through the labor saving of labor and the economic effects of sample management addition.

  Furthermore, problems such as input errors are reduced because of direct transmission from the system.

  The inventors of the present invention have intensively studied to solve the above-mentioned problems, and are able to achieve the above-mentioned problems by periodically reading the control measurement data from the analyzer installed in the facility and comparing it with the cumulative average data. I found it.

  In addition, the present invention significantly improves efficiency and accuracy by collecting data remotely via a telephone line, etc., and managing the measurement data of multiple measuring devices located in multiple hospitals and clinics collectively Made it possible to do.

Thus, according to the present invention, the following inventions 1 to 8 are provided.
1. An automatic external quality control system for analyzers that uses reagents to measure patient samples, and periodically and automatically obtains control measurement data from analyzers installed in multiple facilities, and uses communication means. Evaluation by transmitting to the central data bank, comparing the measured data with the average value of the whole system stored in the central data bank in advance by calculating means, calculating the deviation value, and ranking according to the magnitude of the deviation value Automatic external quality control system.
2. Further, when the deviation value is within a predetermined range, the measurement data is accumulated in the central data bank, and the calculator recalculates an average value of the entire system and stores it again in the central data bank. 2. The automatic external quality control system according to 1 above, wherein when the value is outside the predetermined range, the measurement data is not included in order to recalculate the average value of the entire system.
3. 3. The automatic external quality control system according to 1 or 2 above, wherein the communication means is a personal computer or PDA that can be connected to a telephone line, the Internet, an intranet, an extranet, or the like.
4). 4. The automatic external quality control system according to any one of 1 to 3, wherein the ranked evaluation is a standard deviation value.
5. 5. The automatic external quality control system according to any one of the above 1 to 4, wherein measurement is performed using the same control, and the obtained measurement data is transmitted to and stored in a central data bank using communication means.
6). 6. The automatic external quality control system according to any one of 1 to 5 above, wherein the automatic analyzer is a biochemical automatic analyzer.
7). In the automatic external quality control method of biochemical automatic analyzers that measure patient samples using reagents,
Analyzers arranged in a plurality of facilities obtain control measurement data of the analyzers and send the data to a central server via communication means;
The central server compares the measurement data with an average value of measurement data of all analyzers stored in the central data bank in advance, and outputs a deviation value of the measurement data; and
An automatic external quality control method comprising a step of issuing an evaluation ranked according to the magnitude of the deviation value.
8). Further, when the deviation value is within a predetermined range, the central server accumulates the measurement data in the central data bank and recalculates an average value of the entire system and stores it again in the central data bank;
8. The automatic external quality control according to claim 7, wherein when the deviation value is outside the predetermined range, the central server does not accumulate the measurement data in the central data bank and includes a step of calculating the average value of the entire system. Method.

  Since control data can be transmitted automatically, labor can be saved and errors in data presentation can be reduced.

  In addition, the automatic external quality control system of the present invention makes it possible to quickly measure, transmit, calculate, judge, and return the result of control data, so that the accuracy of the analyzer is outside the predetermined range. Prevent sample measurements from being performed.

  Furthermore, since the automatic external quality control system of the present invention makes it possible to automatically obtain control data at predetermined time intervals from analyzers in each facility, a specialized engineer is not required. Prevent unmeasured data and measurement errors due to human reasons.

Hereinafter, the present invention will be described in detail with reference to the drawings.
FIG. 1 is a conceptual diagram of an automatic external quality control system of the present invention. The analyzer 1 is installed in a hospital or clinic. An examiner or a laboratory technician puts a test sample, which is a test object such as blood collected from a patient, on the analyzer 1 and measures it. The analyzer 1 is, for example, a biochemical analyzer, and the objects to be measured are, for example, cholesterol level, uric acid level, blood glucose level, and the like.

  The examiner or laboratory technician periodically performs measurement by applying a control (or reference standard), which is a test substance having a constant test value, to the analyzer 1, and the control measurement data is connected to the analyzer or to the analyzer. Store in the storage means. In a preferred embodiment, the measured control measurement data is stored in a data storage location (eg, a separate directory) that is separate from normal analyte testing. In the preferred embodiment, measurements are taken every 24 hours, and control measurement data is stored in the storage means each time a measurement is taken.

  The obtained measurement data may be transmitted directly to the central data bank 3 using the communication means 2, or a service technician such as a reagent company or a seller of the apparatus via the additional communication means 2. And then transmitted from the service technician to the central data bank 3 via the communication means 2. The central data bank 3 stores the transmitted measurement data.

  Data transmission may be performed automatically and periodically by the communication means 2 disposed in each facility such as a hospital, or the central server 4 disposed in the central processing facility periodically performs each analysis. Transmission may be initiated by issuing a transmission command to the machine 1.

  When the central server 4 reads the control measurement data from the analyzer 1, the control measurement data may be read from a data storage location separate from the sample test or identified by the ID from the data storage location together with the sample test. The control measurement data may be recognized and read.

  In a preferred embodiment, the communication means 2 is constituted by a personal computer or PDA that can be connected to a telephone line, the Internet, an intranet, an extranet, or the like.

  In addition, the central data bank 3 and the central server 4 are a mainframe or personal computer connected to a telephone line, the Internet, an intranet, an extranet, etc., which are arranged in a quality control business operator contracted with a reagent company or a reagent company. It may be a file server or the like.

  The central server or the computer 4 arranged in the central server reads the measurement data stored in the data bank 3 in advance, obtains an average value of all the analyzers 1 managed by the system, and stores it in the data bank 3. The computer 4 obtains an average value every time new analysis data is accumulated in the data bank 3, and always keeps the latest average value in the data bank 3.

  When new control measurement data is received from the analyzer, the computer 4 compares the received control measurement data with the latest average value stored in the data bank 3, calculates a deviation value, and calculates the deviation value according to the magnitude of the deviation value. Give a ranked rating.

  In the embodiment of the present invention, when the deviation value of the measurement data is within a predetermined range (for example, within 98%), the computer 4 determines that the control measurement data of the analyzer is a normal value, and the measurement data Are stored in the data bank 3 and a new average value is calculated and stored in the data bank 3.

  On the contrary, when the deviation value of the measurement data is out of the predetermined range, the computer 4 determines that the control measurement data of the analyzer is deviated from the normal value, and stores the measurement data in the central data bank. And not included in the average value of the entire system. By doing so, the reliability of the average value of the entire system can be maintained.

  The ranked evaluation is divided into ranks such as A, B, and C as necessary, and the information is returned to the facility where the analyzer 1 is arranged.

  Here, it should be noted that the ranking method described above is described as an example, and other calculation methods may be used depending on the application. For example, even if the measurement data of a specific analyzer is relatively far from the average value, if the accumulated data of that analyzer is always biased in a certain direction and at a certain size, Those measurement data may be judged as normal values.

  The obtained evaluation may be sent to each facility by mail, or may be retrieved by an inspection engineer at each facility accessing the central server 4 through the communication means 2 or the like. If it is determined that the accuracy of the specific analyzer 1 is greatly deviated from the predetermined range, the central server 4 directly accesses the communication means 2 or the user terminal 5 of the facility where the analyzer 1 is located. A warning may be issued to the laboratory technician at each facility. In a preferred embodiment, the user terminal 5 is a personal computer, PDA, or mobile phone that can be connected to a telephone line, the Internet, an intranet, an extranet, or the like. In addition, the abnormality evaluation may be warned not only by the laboratory technician of each facility but also by the person in charge of the reagent / equipment company.

  If an abnormality is evaluated, the laboratory technician checks the analyzer and the corresponding test reagent and responds. In that case, the person in charge of the reagent / equipment company may cooperate.

  Since the analyzer 1 in the hospital maintains proper analysis by the automatic quality control system of the present invention, errors due to the measurement data are less likely to occur, and the measurement data becomes highly reliable.

  This system makes it easy for small and medium-sized hospitals to carry out specimen test measurements independently, and by performing these tests, the examiner or laboratory technician can immediately obtain the test results of the test sample collected from the specimen. Therefore, early diagnosis and early treatment can be performed.

  The control used in the present invention is usually human serum, but other controls can be used.

  In the present invention, examples of the sample include blood and urine collected from a person.

  The analyzer automatic accuracy management system and method of the present invention can be used in hospitals and clinics. In particular, it can be suitably used in places where introduction of measuring devices is being considered in small and medium-sized hospitals and clinics. That is, since the present invention does not involve the complexity of accuracy management, it is possible to reduce the management of measuring instruments by an inspection engineer. Small and medium-sized hospitals and clinics that have been unable to maintain these measuring devices conventionally can hold these measuring devices.

1 is a schematic diagram showing a system for carrying out an automatic external quality control system and an automatic external quality management method of the present invention.

Explanation of symbols

1 analyzer 2 communication means 3 data bank 4 computer or central server 5 user terminal

Claims (8)

  An automatic external quality control system for analyzers that uses reagents to measure patient samples, and periodically and automatically obtains control measurement data from analyzers installed in multiple facilities, and uses communication means. Evaluation by transmitting to the central data bank, comparing the measured data with the average value of the whole system stored in the central data bank in advance by calculating means, calculating the deviation value, and ranking according to the magnitude of the deviation value Automatic external quality control system.   Further, when the deviation value is within a predetermined range, the measurement data is accumulated in the central data bank, and the calculator recalculates an average value of the entire system and stores it again in the central data bank. 2. The automatic external quality control system according to claim 1, wherein when the value is outside the predetermined range, the measurement data is not included in order to recalculate the average value of the entire system.   The automatic external quality control system according to claim 1 or 2, wherein the communication means is a personal computer or a PDA that can be connected to a telephone line, the Internet, an intranet, an extranet, or the like.   The automatic external quality control system according to any one of claims 1 to 3, wherein the ranked evaluation is a standard deviation value.   5. The automatic external quality control system according to claim 1, wherein measurement is performed using the same control, and the obtained measurement data is transmitted and stored in a central data bank using communication means.   The automatic external quality control system according to any one of claims 1 to 5, wherein the automatic analyzer is a biochemical automatic analyzer. In the automatic external quality control method of the biochemical automatic analyzer that performs patient sample measurement using reagents,
Analyzers arranged in a plurality of facilities obtain control measurement data of the analyzers and send the data to a central server via communication means;
The central server compares the measurement data with an average value of measurement data of all analyzers stored in the central data bank in advance, and outputs a deviation value of the measurement data; and
An automatic external quality control method comprising a step of issuing an evaluation ranked according to the magnitude of the deviation value. Further, when the deviation value is within a predetermined range, the central server accumulates the measurement data in the central data bank and recalculates an average value of the entire system and stores it again in the central data bank;
8. The automatic external processing according to claim 7, comprising a step in which the central server does not accumulate the measurement data in the central data bank and does not count into an average value of the entire system when the deviation value is outside the predetermined range. Quality control method.

Images