JP4436879B2 - Quality control method - Google Patents

Description

The present invention relates to a quality control method for performing quality control at least between facilities using a quality control sample in clinical examination.

  The most objective provision of medical diagnosis is clinical testing. For correct diagnosis, the test information must be reliable. For high objectivity and reliability, the accuracy and precision of inspection results must be maintained and managed over a long period of time. In order to give appropriate quality assurance (Quality Assurance, QA) to inspection information based on the accuracy management, it can be said that it is difficult to achieve in each laboratory. Therefore, information exchange and cooperation among many laboratories is essential.

  Conventionally, however, it has not been easy to exchange information and cooperate with many laboratories regarding accuracy control.

  Therefore, the present inventor needs internal quality control (Internal Quality Control, IQC) in order to establish stable measurement accuracy in each laboratory, and further, external quality assessment (External Quality Assessment) between laboratories. .EQA), a system for sharing information was constructed.

The present invention collects measurement data obtained by measuring a quality control sample with an analytical instrument for clinical testing in a facility from a terminal of the facility to a server via the Internet, and the server collects measurement data collected from each facility. Error check, including whether the lot number is valid, whether it is within the expiration date, and whether the facility code is registered. Excluding the measured data , the total of the measured data is totaled, and the average value and standard deviation of the measured data are obtained as monthly statistical data related to external quality control, and the measured data of the facility and the total average value ± 2 Create a control chart showing the relationship with the standard deviation, and distribute monthly statistical data related to external accuracy control including the control chart to the facility terminals via the Internet It provides quality control method characterized by.

According to the present invention, it is possible to provide a quality management method related to data management and transfer of a designated quality control sample, data collection and aggregation, and data analysis and analysis data distribution. Particularly characteristically, it is possible to provide an accuracy management method for distributing a control chart for inter-facility accuracy management.

(1) Accuracy assurance system (eQAP * registered trademark)
The internal quality control software provided to the contract facility operates under, for example, an OS of Windows (registered trademark) 95/98 or later. In the data analysis department, for example, Windows (registered trademark) NT is prepared as a data collection and distribution server (QAP * registered trademark server). For data analysis and result output, a general-purpose backbone system is installed, and a firewall is installed between servers to protect the system. The facility information and the facility management data are preferably linked with a facility code and are designed in consideration of leakage of facility information.
(2) Data collection and distribution via the Internet In order to improve real-time evaluation, weekly evaluation (with immediacy based on weekly evaluation) and monthly evaluation (mainly graphic reports). ), And was constructed so that it can be evaluated on a yearly basis (evaluation of improvement in results over time). In this system, daily aggregation is possible in principle, so it can be changed depending on the reduction of communication costs.

  For data transfer from participating facilities, you can automatically connect to the data analysis department if there is an Internet environment in which FTP software (file transfer software) is built into the internal quality control software “MCP-QC”. Software can send daily quality control data from participating facilities.

Data transfer can be accepted at any time by the data analysis department, and weekly aggregation is performed, and a preliminary report consisting of individual data of each facility and total aggregation is sent to the participating facilities on a fixed-length basis on the following Monday. Reply by eMail as text format.
(3) Monthly summary results Monthly summary results are included for participating facilities other than the Internet. The monthly total value can be selected from two types of data providing methods according to the request of participating facilities. The two types of providing formats are a form report format and a CD-ROM medium. In the form report format, for example, there are ten or more types of forms, which are divided into forms provided every month and forms provided in a specified month. In the CD-ROM medium format, for example, three types of databases (QAP total data, facility data, and QAP code master) are recorded. These are fixed length and CSV text formats. Browsing software “QAP-Viewer” was recorded on CD-ROM for the purpose of observation. It is possible to analyze the participating facilities themselves using spreadsheet software (Excel etc.). A QAP homepage is set up, and nationwide aggregated values are posted on this homepage. This total value is updated on a weekly basis. Data can be viewed, downloaded, and managed using general-purpose browser software.
(4) Facility observation In the present system, the facility can be observed by the browsing software “QAP-Viewer”. As a result, the screen inquiry can be made with the first minimum environment setting such as the facility code, and the facility data for the nation-wide aggregated value can be confirmed with the five types of management graphs. A total of various measurement conditions is prepared for the nationwide aggregate value, and measurement methods, analytical instruments, and calibration methods are prepared for the measurement conditions, and these two types of combinations are compiled into a database to set extraction conditions. There is no need for complexity. If you participate in multiple units or in a group at the same facility, you can also register facility codes for multiple facilities.
(5) Code system In this system, standardization of the control survey and code system implemented by various organizations was conducted. The test item code uses the test item code of the Japan Society of Clinical Pathology, the analysis device code uses the analysis device code of the Japan Analytical Machinery Association, the method code conforms to the code of the Japan Medical Association Quality Control Survey, and the calibration code is We revised and used the availability of standard materials certified by academic societies and various measurement conditions, and prepared a condition code for the facility number corresponding to multiple prefecture analysis conditions and laboratory analysis conditions.
(6) Group tabulation This system supports group tabulation, and can handle large to small survey analysis in addition to nationwide tabulation. Can support surveys sponsored by academic groups, such as large-scale prefectural regional surveys (National Medical Association, Technician Association, Sanitation Bureau) such as the Nichi-Iken Survey, the Nichirin-Kyo Survey, and the Japan Welfare Survey, and related hospital groups ( Medical Associations, National Sanatoriums, Company-wide Federations, Industrial Accidents, Clinical Laboratory Centers), and small group counts (such as research groups).

The aggregation period can correspond from a monthly continuous survey to a one-shot survey, and the group-by-group aggregation results can be emailed to the leader facility of the group, and stored on the monthly CD-ROM media along with the national value. Participating facilities can easily confirm the location from the national value from the location confirmation in group units. A survey of each manufacturer can be performed, for example, an analytical instrument / test drug manufacturer.
(7) Enhancement of internal accuracy management Software for accuracy management was prepared for the purpose of enhancing internal accuracy management. Participating facilities were provided with quality control software “MCP-QC” and overcheck tables were prepared for the purpose of efficient use of multiple quality control methods. "Precise evaluation method" using daily quality control data can be performed. Guideline for revision of precision and accuracy of quantitative tests in clinical chemistry (GC-JAMT-1999). Thus, in daily life, not only daily quality control but also daily fluctuations and daily fluctuations can be confirmed by a precision evaluation method using the quality control software “MCP-QC”.
(8) Confirmation of accuracy In this system, software for evaluating the accuracy and accuracy of quantitative inspection “MCP-STAT” can be used to confirm the accuracy of quantitative inspection. Thereby, the accuracy can be confirmed by linear regression analysis using three or more kinds of standard serum samples in the guideline for evaluation of quantitative accuracy.
(9) Providing basic statistics using the one-way analysis of variance method In this system, daily quality control data can be evaluated for daily and daily fluctuations using the same analysis method. Intra-facility variability, inter-facility variability, and total variability can be provided by the same method based on the reported one-month facility data.

Flow of this system (eQAP) (1) Category The category of the accuracy assurance system of the present invention covers biochemical tests, immune serum tests, blood coagulation tests, glycohemoglobin tests, clinical test-related fields, research reagent fields, etc. Is targeted.
(2) Participation / registration The registration details of participation registration are facility information (facility number, facility name, department, person in charge, TEL, FAX, E-MAIL, management entity, number of beds), registration item reference range, cutoff Values are registered, and the registration method is to register the eQAP dedicated server after issuing the facility number and password.
(3) Participation preparation Upon participation, the participation item measurement conditions are selected, the facility code and password are confirmed, the Internet connection environment is confirmed, and the internal quality control software “MCP-QC” is set up. Register the measurement conditions for participating items, reference values for control charts, etc. in the MCP-QC, and transfer management data for one week or one month to the data analysis department.
(4) Data movement The facility side performs daily accuracy management as a data check, and the management value is stored in “MCP-QC”. Data is sent out via Internet transmission on a daily or weekly basis, postal mail on a monthly basis, fax, or the like.

  The data analysis department performs an error check on facilities, measurements, and reported values as a data check. Excludes extreme values in the facility's cumulative average ± t x standard deviation (t = 4), and from the total tabulation, the lower level-t x standard deviation and the upper level + t x standard deviation (t = 3) Exclude extreme values. The totaling process classifies measurement methods and analytical equipment, and totals the fluctuation values within and between facilities. And the total result for every participating facility and the total total result are created. Monthly tabulation results are prepared in a form format and text data.

  The return of the obtained result is eMail (the result of the weekly aggregation is returned to the participating facility of the eMail registration. However, it is possible to cope with daily aggregation by reducing the communication cost etc.), CD-ROM (the aggregation data is the viewing software “ QAP Viewer ”), form format (sorted shipping), QAP homepage (participating facility QAP server).

  The facility then reviews the report. For example, you can immediately compare the accuracy with the national value in the weekly aggregation result in E-Mail, and in the monthly aggregation result, you can check the location of the participating facilities in the form report, distribution data and browsing software "QAP Viewer" Can be used to visually check national values and facility values using five types of control charts, and can be analyzed in many ways from detailed tabulation results that are not prepared in the form.

MCP-QC internal quality control software This software will enhance daily quality control and strengthen cooperation with the data analysis department. System operating environment is NEC PC-9821 series or PC / AT compatible machine with the following OS. An environment in which MicroSoft Access 97 operates normally. In order to transmit data via the Internet, an environment that can be connected to the Internet via a modem, TA, or LAN is required. CPU: Intel Pentium (registered trademark) 100 or more required, Memory: 32 MB required, 64 MB or more recommended, Hard disk: 200 MB or more free space required, Display: Windows (registered trademark) compatible display, screen 600 x 800 dots 256 colors This is necessary. OS: WINDOWS (registered trademark) 95/98, other: CD-ROM drive essential (used during installation), etc.

  The feature of this software is that it prepares 10 kinds of control charts and overcheck tables for daily, daily and monthly. The reference value of the control chart can be selected from the set values for facilities and external surveys The quality control data can be sent to the data analysis department using the Internet. For example, a precision evaluation method was adopted.

  The program content includes two types of data input (daily data input, mat input), QC converter (QC text data can be used in MCP-QC), X-Rs control chart, multi-rule (1 -3s, 2-2s, R-4s, 10-XB), PLUS-MINUS control chart, precision evaluation, and the like. For daily accuracy management work, daily data input (calculated from statistical value input, intraday data), Xb-Rs-R control chart, multi-rule (1-3s, 2-2s, R-4s, 10-XB) , Youden Plot control chart (evaluation standard ± 2SD, correlation ellipse, Mahalanobis general distance), TREND control chart (Accuracy trend, Precision trend, Decision Limit Cusm), overcheck table (by item, by date), etc. The monthly accuracy management business has functions such as monthly data input, Xbar-S control chart, SDA / SDP TWINPLOT, and the like. The data analysis department communication program has a monthly QAP control chart function.

The operating environment of the QAP-Viewer software system is NEC PC-9821 series or a PC / AT compatible machine with the following OS. CPU: Intel Pentium (registered trademark) 100 or more required, Memory: 32 MB required, 64 MB or more recommended, Hard disk: 20 MB or more free space required, Display: Windows (registered trademark) compatible display, screen is 600 × 800 dots, 256 Need more than color. OS: WINDOWS (registered trademark) 95/98, others: CD-ROM drive essential.

  The characteristics are that it is possible to easily create a graph from QAP total data and facility data recorded on the CD-ROM distributed by the data analysis department, that the location of the facility can be confirmed from the whole and the location of the group, MCP at the facility where the report was made in paper -It is possible to grasp the location of the facility from the whole without using QC.

  Program contents are SDA / SDP TWIN PLOT (Plot SDA and SDP to confirm the location of all items), QAP control chart (can observe the whole, group and location of each facility), TWIN PLOT (± Enclosed in 2SD frame to represent own facility), technology / factor chart (good / careful / bad for each facility, systematic error, random error), QAP MATRIX ) And options (lot changes, measurement conditions, records of multiple facilities), etc.

QAP homepage The QAP homepage has an analysis graph prepared on the QAP server, and the facility data can be compared with the national value by simply pasting the data on the homepage. A QAPNews bulletin board is created, enabling search of required documents by entering search items. The summary of the commemorative lecture will be posted.

Details of basic program (QAP) embedded in eQAP Basic data calculation method Data is processed by the following formula.
MEAN: When the average value of n data is X1 X2 X3 ... Xi ... Xn

Ｂ．検査室（施設）内精度（ＩＮＴＲＡ−ＬＡＢ）（内部精度）および検査室（施設）間精度（ＩＮＴＥＲ−ＬＡＢ）（外部精度）の計算方法
各検査室のデータは下表１のようにまとめることができ、次の計算法によりデータ処理する。

B. Calculation method of the accuracy in the laboratory (facility) (INTRA-LAB) (internal accuracy) and the accuracy between the laboratories (facility) (INTER-LAB) (external accuracy) The data of each laboratory should be summarized as shown in Table 1 below. The data is processed by the following calculation method.

Ｃ．ｅＱＡＰ５０（ＲＡＷＤＡＴＡ ＣＯＮＶＥＲＳＩＯＮ（ＥＲＲＯＲ））
こレポートは各施設のデータ記入用紙に記入されたデータに対しロット番号が有効か、年月が有効か、施設コードが登録されているか、項目コードなど一連のコードにミスがないかなどのチェックを行うものである。方法コードにないコードが記入されたり、プログラムで異常と判定されたデータは計算から除外し、次の例のようなメッセージを表示し、ＦＬＡＧの欄に＊ＥＲＲを出力して計算から除外されたことを示す。表２にその一覧を示す。

C. eQAP50 (RAWDATA CONVERSION (ERROR))
This report checks whether the lot number is valid for the data entered on the data entry form of each facility, whether the year and month are valid, whether the facility code is registered, and whether there is a mistake in a series of codes such as item codes. Is to do. Data that is not in the method code is entered or data judged abnormal by the program is excluded from the calculation, a message like the following example is displayed, and * ERR is output in the FLAG column and excluded from the calculation It shows that. Table 2 shows the list.

Ｄ．ｅＱＡＰ７０（ＲＡＷ ＤＡＴＡ ＭＡＩＮＴＥＮＡＮＣＥ ＲＥＰＯＲＴ（ＰＲＯＯＦ））
このレポート（表３）では、ｅＱＡＰ５０のチェックを通過したデータが統計計算され、ＭＥＡＮ、ＳＤ、Ｎのそれぞれが日毎、週毎または月毎に項目別、ＬＥＶＥＬ別に出力される。以後の各施設のデータ処理の基礎となる数字である。なお、このレポートは毎週金曜日の夕方までにインターネットで送信された施設に対し、翌週の月曜日までにｅメールで返信可能である。

D. eQAP70 (RAW DATA MAINTENANCE REPORT (PROOF))
In this report (Table 3), the data that passed the eQAP50 check is statistically calculated, and MEAN, SD, and N are output by item, LEVEL by day, week, or month. It is a number that is the basis for data processing at each facility thereafter. Note that this report can be returned by e-mail to Mondays the following week for facilities sent over the Internet by Friday evening.

Ｅ．ｅＱＡＰ２１０（ＩＮＤＩＶＩＤＵＡＬ ＭＯＮＴＨＬＹ ＨＩＳＴＯＲＹ）
このレポート（表４）は、ｅＱＡＰ７０で計算されたＭＥＡＮ、ＳＤ、Ｎの他にＣＶ、ＳＤＩ、ＳＤＰ、ＳＤＡのそれぞれを項目別、ＬＥＶＥＬ別、月別に出力したものである。出力は左側より当月分、１ヶ月前、２ヶ月前の順に１１ヶ月前まで、すなわち１２ヶ月分が１行に出力され右端に開始月より当月迄の累計が出力される。なお、各月のデータの上に年月が出力され、何月分のデータであるかが見分け易くなっている。

E. eQAP210 (INDIVIDUAL MONTHLY HISTORY)
In this report (Table 4), in addition to MEAN, SD, and N calculated by eQAP70, CV, SDI, SDP, and SDA are output by item, by LEVEL, and by month. The output from the left side is the current month, 1 month ago, 2 months ago in the order of 11 months ago, that is, 12 months are output in one line, and the total from the start month to the current month is output at the right end. Note that the year and month are output on the data of each month, so that it is easy to distinguish the number of months.

In addition, the start month and the last month are output in order to make it easy to understand from what month to what month the cumulative data is.
1) The SDI shows how far the monthly MEAN is compared to the cumulative MEAN, based on the cumulative SD, and the formula is (MEAN of the current month-cumulative MEAN) / (cumulative SD). ).
2) The SDP is a comparison of the SD of the own facility and the cumulative SD of the INTRA-LAB by item, and if it is smaller than 1, it indicates that it is smaller than the average value. The calculation formula is (SD of own facility) / (cumulative SD of item-specific INTRA-LAB).
3) The SDA shows how far the MEAN of its own facility is from the cumulative MEAN by item, based on the cumulative SD of INTER-LAB by item. The calculation formula is (MEAN of own facility-MEAN of totals by item) / (SD of totals of INTER-LAB by item).

Ｆ．ｅＱＡＰ２１５（ＩＮＤＩＶＩＤＵＡＬ ＭＯＮＴＨＬＹ ｓｕｍｍａｒｙ）
このレポート（表５）では 自施設の当月と累計のＭＥＡＮ、ＳＤ、ＣＶと全施設の累計のＭＥＡＮ、ＳＤ、施設数及び自施設のＳＤＩ、ＳＤＡ、ＳＤＰ、ＳＣＯＲＥおよびＪＵＤＧＥがそれぞれ項目別、ＬＥＶＥＬ別に出力される。ＳＣＯＲＥはＳＤＡが±１．００未満の場合は５点、±１．００以上±２．００未満の場合は３点、±２．００以上±３．００未満の場合は１点、±３．００を超える場合は０点となる。また、ＪＵＤＧＥはレベル１とレベル２のＳＤＡを散布図に描いたとき、下表のようにプロットされる場所により右下のように判定される。なお、このレポートは毎週金曜日夕方までにインターネットで送信された施設に対し、翌週月曜日までにｅメールで返信される。

F. eQAP215 (INDIVIDUAL MONTHLY summary)
In this report (Table 5), the current month and cumulative MEAN, SD, and CV of the facility and the cumulative MEAN, SD, the number of facilities, and SDI, SDA, SDP, SCORE, and JUDGE of each facility Output separately. The SCORE is 5 points when the SDA is less than ± 1.00, 3 points when the SDA is more than ± 1.00 and less than ± 2.00, 1 point when the SDA is more than ± 2.00 and less than ± 3.00, and ± 3. If it exceeds 00, it will be 0 points. JUDGE is determined as shown in the lower right, depending on where it is plotted as shown in the table below when Level 1 and Level 2 SDA are drawn on a scatter diagram. This report will be returned by e-mail to the facility sent via the Internet every Friday evening by the following Monday.

Ｇ．ｅＱＡＰ２２０（ＩＮＴＥＲ−ＬＡＢ ＲＥＰＯＲＴ：施設間レポート）
このレポート（表６）はＩＮＴＥＲ−ＬＡＢ ＲＥＰＯＲＴと呼ばれ、ｅＱＡＰ２１０で出力されたものを項目別、方法別、機器別に並べかえたものである。そして機器毎、方法毎及び項目毎にＭＥＡＮ、ＳＤ、ＣＶ、ＤＡＹＳが計算され、各分類毎に３種類の計算値が出力される。

G. eQAP220 (INTER-LAB REPORT: Inter-facility report)
This report (Table 6) is called INTER-LAB REPORT, and is a list of items output by eQAP 210 sorted by item, method, and device. MEAN, SD, CV, and DAYS are calculated for each device, method, and item, and three types of calculated values are output for each classification.

  The three types of calculated values are GROUP TOTAL, INTRA-LAB, and INTER-LAB. Since MEAN and DAYS are common, MEAN is output only to GROUP TOTAL, and DAYS is output only to INTER-LAB.

  The INTRA-LAB SD is the average SD of each facility included in the group, and the CV similarly represents the average CV of each facility. Therefore, it is possible to compare the variation in individual laboratories with the average variation in other laboratories.

  The INTER-LAB SD indicates the degree of variation of the MEAN of each facility, and this is for checking whether the MEAN of the own facility is within the range of MEAN ± 2SD of the group.

  ALL METHODS ALL LAB's GROUP TOTAL is a calculated value from all laboratories and all data. An "X" in the FLG term indicates that LEVELEL or LEVELII MEAN is outside the range of ALLMETHODS ALL LABES MEAN ± 3SD, so it was excluded from the calculation to prevent moving the average value. . Data is collected for each method and each device, and the code numbers are entered in ascending order.

  This report is issued once per lot within 7 months after the start of new lot supply.

Ｈ．ｅＱＡＰ２３０（ＩＮＴＥＲ−ＬＡＢ ＳＵＭＭＡＲＹ ＲＥＰＯＲＴ：施設間集計レポート）
このレポート（表７）はＩＮＴＥＲ−ＬＡＢ ＳＵＭＭＡＲＹ ＲＥＰＯＲＴと呼ばれ、ｅＱＡＰ２２０で出力されたものから項目別、方法別、機器別、較正別に集計した累計結果を抽出したものである。そして全体、方法別、機器毎、較正別のＭＥＡＮ、ＳＤ、ＣＶ、ＩＮＴＲＡ ＳＤ、ＩＮＴＲＡ ＣＶ、ＩＮＴＥＲ ＳＤ、ＩＮＴＥＲ ＣＶおよび施設数が出力される。なお、各分類の最小集計数は５施設以上に限定しているが、方法別では上位１０方法、機器別では上位２０機種、較正別は上位８方法まで掲載している。このレポートは、小冊子により隔月発行となっている。最新データは毎週更新され、ホームページよりリンクされたＱＡＰホームページよりテキストデータとして閲覧もしくはダウンロードすることができる。

H. eQAP230 (INTER-LAB SUMMERY REPORT)
This report (Table 7) is called INTER-LAB SUMMERY REPORT, and it is the result of extracting the accumulated results that are tabulated by item, method, device, and calibration from the output from eQAP220. Then, MEAN, SD, CV, INTRA SD, INTRA CV, INTER SD, INTER CV and the number of facilities are output as a whole, by method, by device, by calibration. Although the minimum number of totals for each category is limited to 5 or more facilities, the top 10 methods are listed by method, the top 20 models by device, and the top 8 methods by calibration. This report is published every other month in a booklet. The latest data is updated weekly and can be viewed or downloaded as text data from the QAP homepage linked from the homepage.

Ｉ．ｅＱＡＰ３２０（クリニカル・レベル・ヒストグラム）
ｅＱＡＰによって得られたデータに施設間差があったとしても、各施設で、その施設にふさわしい基準範囲を採用していれば、患者の診断には支障がない。つまり、ある複数の病院間で同一試料の測定値が違っていても、クリニカル・レベルが同じであるならば、同一診断が下されるということである。クリニカル・レベルとは基準上限値で試料の測定値を割った値のことをいう。これをヒストグラムにし、施設別にその位置を明確にすることにより、各施設の単位の変更とか基準範囲の見直しを促すものである。このプログラムでは、レベルＩとレベルＩＩが並んで打ち出されるから、低値と高値の傾向を基準上限値の比として把握するのに適している。ただし、このプログラムは各施設の基準上限値とＱＡＰデータの累計値より計算されるので、基準範囲登録のない施設にはレポートの提供はできない。このヒストグラムはデータサービス開始時点の平均±２ＳＤで作成し、これを外れるデータは最小級と最大級にまとめて出力される。なお、この級幅はある時点で固定致しますからクリニカル・レベルの変化は＊印の移動になって表れる。

I. eQAP320 (clinical level histogram)
Even if there is a difference between facilities in the data obtained by eQAP, if each facility adopts a reference range suitable for the facility, there is no problem in diagnosis of the patient. That is, even if the measured values of the same sample are different among a plurality of hospitals, the same diagnosis is made if the clinical level is the same. The clinical level is a value obtained by dividing the measured value of the sample by the reference upper limit value. By making this a histogram and clarifying the position of each facility, it is urged to change the unit of each facility or review the reference range. In this program, since level I and level II are launched side by side, it is suitable for grasping the tendency of the low value and the high value as the ratio of the reference upper limit value. However, since this program is calculated from the standard upper limit value of each facility and the cumulative value of QAP data, it is not possible to provide a report to facilities that do not have a standard range registration. This histogram is created with an average of ± 2SD at the start of data service, and data that deviates from this is output in a minimum and maximum class. This class width will be fixed at a certain point in time, so changes in the clinical level will appear as movements marked with *.

Ｊ．ＱＡＰ３３０（測定値散布図）
表９は、各施設の累計の平均値をプロントしたもので、横軸にＬＥＶＥＬ Ｉ、縦軸にＬＥＶＥＬ ＩＩを取る。自施設のデータを箱囲み数字印、自施設と同じ方法のデータを星（☆）印とし、他方法の打出しはしていない。他方法のデータについてはその中心値のみ英字で打出した。このレポートは、自施設と同じ方法のデータ分布の中で自施設データの位置及び中心値からのずれを施設間ＳＰを基準にして判断できる。

J. et al. QAP330 (Measurement value scatter diagram)
In Table 9, the cumulative average value of each facility is printed, with LEVEL I on the horizontal axis and LEVEL II on the vertical axis. The data of the own facility is boxed and numbered, and the data of the same method as the own facility is marked with a star (*). For the data of other methods, only the central value was presented in English letters. This report can determine the deviation from the position and the center value of the self-facility data in the data distribution of the same method as the self-facility based on the inter-facility SP.

３ＳＤを越すデータは越えたデータに関係なく３ＳＤラインの外側に打出される。自施設と同じ方法の分布中心点は他方法の中心点と同じ様に英字で打出される。なお、このレポートは各施設の累計データが使用される。この散布図は、上位９番目までの方法に限定している。
Ｋ．ＱＡＰ３５０（施設内／施設間変動散布図）
この散布図（表１０）は、横軸に測定値及び相対偏差をとり、縦軸に施設内ＣＶをとったもので、散布図を囲む４辺は各々次の目盛りを付けてある。即ち、全方法の平均ａを上辺の↓矢印、±２ＳＤを括弧（ ）で示し、自施設と同方法の平均ａを下辺の↑矢印、±２ＳＤを括弧（ ）で示した。また、自施設と同方法のＣＶ平均値を左辺の→矢印で示し、全方法のＣＶの平均値を右辺の←矢印で示した。自施設データの位置は、数字ｃ印で打出され、自施設と同方法のデータの位置は☆で、他方法のデータの位置は×印で打出される。

Data exceeding 3SD is stamped outside the 3SD line regardless of the data exceeding. The distribution center point of the same method as that of its own facility is printed out in English like the center point of other methods. This report uses the cumulative data of each facility. This scatter diagram is limited to the top nine methods.
K. QAP350 (Inside / intra-facility variation scatter diagram)
In this scatter diagram (Table 10), the horizontal axis represents the measured value and relative deviation, and the vertical axis represents the in-facility CV. The four sides surrounding the scatter diagram are each marked with the following scale. In other words, the average a of all methods is indicated by an arrow on the upper side, ± 2SD is indicated by parentheses (), the average a of the same method as the own facility is indicated by an arrow on the lower side, and ± 2SD is indicated by parentheses (). In addition, the CV average value of the same method as that of the own facility is indicated by the → arrow on the left side, and the CV average value of all methods is indicated by the ← arrow on the right side. The position of the own facility data is stamped by the number c, the position of the data of the same method as the own facility is marked by ☆, and the position of the data of other methods is stamped by the mark ×.

  From this figure, the relative size of the in-facility CV of the own facility data and how far the average value of the own facility data is from the average value of all data in the same method can be grasped as a unit of measurement and as a relative proportion. is there.

The calculation of the relative deviation is the quotient obtained by subtracting the average of all measured values of the same method from the average of measured values of each facility and dividing the difference by the average of all measured values of the same method.
(Ai-b) ÷ b
ai: Average value of measured values of each facility b: Calculated by the average value of all measured values of the same method. This shows how far the average value of the facility is from the average value of the same method. Similarly, the relative deviation value for each method is shown as a percentage of how far the average value of each method is from the overall average value.

Ｋ．ｅＱＡＰ ３６０（施設別ＳＤＡ・ＳＤＰ ツインプロット）
１）ＳＤＡ ツインプロット
このグラフ（表１１左）は１枚のグラフに全項目の自施設の測定値（累計の平均値）の位置をプロットするものである。グラフの目盛は各項目の累計のＩＮＴＥＲ ＬＡＢの１ＳＤに相当する。そしてＬＥＶＥＬＩ、ＩＩ共にＭＥＡＮ〜ＭＥＡＮ＋１ＳＤのデータは中心の右上の白い部分にその項目に相当する文字が印字される。

K. eQAP 360 (SDA / SDP twin plot by facility)
1) SDA Twin Plot This graph (left side of Table 11) plots the position of the measured value (average value of the total) of all facilities in one graph. The scale of the graph corresponds to 1 SD of the INTER LAB for each item. For both LEVELI and II, MEAN to MEAN + 1SD data are printed with characters corresponding to the items in the white upper right corner.

This data corresponds to the case where the cumulative SDA is 0 to 1 in the eQAP 210. If the LEVEL I SDA is (+), it is plotted on the right side of the center, and if the LEVEL II SDA is (+), it is plotted on the upper side. However, the position of this plot is not accurate, and if the SDA is 0 to 1, it is printed in the central white part, but the printing position is printed in order from the upper left to the lower right. In other words, if it is printed in the white part of the center, it means that it is within MEAN ± 1SD of INTER LAB of ALL METHODS ALL LABS, and if it is within the next black part, it is within MEAN ± 2SD. Represents that
2) SDP Twin Plot This graph (upper right of Table 11) is a graph of the total SDP of eQAP210, and one scale of this graph corresponds to 1SD of INTRA LAB of ALL METHODS ALL LABS. Similar to SDA, the plot of the graph is plotted to the right when LEVELI increases, and upward when LEVELII increases. The printing method is the same as SDA.
3) PERFORMANCE
In the graph of the SDA twin plot, 5 points of data within 1 SDA, 4 points of data within 2 SDA, and 2 points of data within 3 SDA are added together (lower right of Table 11). If the total is 5 points, it becomes 100%, but the percentage decreases as 4 points or less increase. This score itself has no particular meaning, but as the number of 5 points increases, that is, the closer to 100%, the closer to the overall average value, the more data is output.

Ｌ．ｅＱＡＰ １５０（統計値入力フォーム）
この入力フォーム（表１２）は、施設から提出されたデータの方法、分類、機器、標準、温度、試薬メーカーなどのコードを印刷したものである。１ヶ月間の平均値、ＳＤ、測定日数を記入するだけで、報告レポートが作成できる。

L. eQAP 150 (statistical value input form)
This input form (Table 12) is a printed code of the method, classification, equipment, standard, temperature, reagent manufacturer, etc. of the data submitted from the facility. A report report can be created simply by entering the average value, SD, and measurement days for a month.

Details of QAP-Viewer (browsing software) Table 13 below shows the main menu of QAP-Viewer.
You can work by clicking the dialog button of each work.

１）ＳＤＡ／ＳＤＰ ＴＷＩＮ ＰＬＯＴ
横軸をＱＡＰトロール１Ｘ、縦軸をＱＡＰトロール２Ｘとし、全体の平均値を基準としてＳＤ単位で区切られた２種類の管理図のなかにデータを項目名でプロット表示した（表１４）。

1) SDA / SDP TWIN PLOT
The horizontal axis is QAP troll 1X, the vertical axis is QAP troll 2X, and data is plotted by item name in two types of control charts divided in SD units based on the overall average value (Table 14).

  The SDA control chart is a plot of the difference between the average value of the facility for the current month and the overall average value divided by the INTER-LAB SD of the average value of all facilities, and is a control chart for viewing the accuracy. It is. Blue within ± 1SD, purple with 1SD to 2SD, and red with 2SD above 2SD. The SDP control chart is a chart for plotting the value obtained by dividing the SD value for the current month by INTRA-LAB SD, which is an indicator of the average variation in all facilities. is there. The values within ± 1 times are indicated by ◯, 1 to 2 times are indicated by Δ, and 2 times or more are indicated by ×.

２） ＱＡＰ管理図
表１５は、施設の当月平均値が全国集計値と比較してどの位置にあるかをレベル別に確認できる。全体平均値を中心にして±３ＳＤを外枠に描き、±１ＳＤ毎に点線を描いた。キーコードで分類した自施設と同じグループの平均値±２ＳＤ枠を内側に四角形で描く。施設のデータをその中に●でプロットする。右側の表は自施設の測定値、キーコードで分類した自施設と同じグループの平均値、ＳＤおよび施設数、全体の平均値、ＳＤおよび施設数である。

2) QAP control chart Table 15 shows the location of the facility's monthly average value compared to the nationwide total value by level. ± 3SD was drawn on the outer frame around the overall average value, and a dotted line was drawn every ± 1SD. Draw an average value ± 2SD frame of the same group as your own facility classified by key code with a rectangle inside. Plot the facility data in it. The table on the right side shows the measured value of the own facility, the average value of the same group as the own facility classified by the key code, the SD and the number of facilities, the overall average value, the SD and the number of facilities.

３） ＴＷＩＮ ＰＬＯＴ
横軸をＱＡＰトロール＊１Ｘ、縦軸をＱＡＰトロール２Ｘとした散布図のなかで、施設のデータを●でプロットする。全体平均値を中心にして±３ＳＤを外枠に描いた。キーコードで分類した各要素の平均値±２ＳＤの枠をカラー線（図中複数の枠は各色が異なる）で描く。＊は、精度管理試料の名称。

3) TWIN PLOT
In the scatter diagram with the horizontal axis QAP Troll * 1X and the vertical axis QAP Troll 2X, plot the facility data with ●. ± 3SD was drawn on the outer frame with the overall average as the center. A frame of the average value ± 2SD of each element classified by the key code is drawn with a color line (a plurality of frames in the figure have different colors). * Is the name of the quality control sample.

４） 技術・要因チャート
全体の平均値を中心として１ＳＤ単位で区切られた基盤のなかに施設のデータを項目名でプロット表示する（表１７）。技術評価チャートでは、プロットされた位置より良好、要検討、不良・原因追求の区分を行う。因分析チャートでは更に異常が発生した場合の位置によってその項目が系統的誤差（Ｓｙｓｔｅｍａｔｉｃ Ｅｒｒｏｒ：ＳＥと略す）または、ランダム誤差（Ｒａｎｄｏｍ Ｅｒｒｏｒ：ＲＥと略す）または、片側誤差（Ｏｎｅ−ｓｉｄｅＥｒｒｏｒ：ＯＥと略す）かを判断し、誤差要因の原因を追求し易くした。

4) Technology / Factor Chart The facility data is plotted and displayed by item name in the base divided by 1SD unit around the average value of the whole (Table 17). In the technical evaluation chart, classification is made into better, more important examination, and failure / cause pursuit than the plotted positions. In the cause analysis chart, the item may be a systematic error (abbreviated as SE), a random error (abbreviated as RE), or a one-sided error (One-sideError: OE) depending on the position when an abnormality further occurs. To make it easier to pursue the cause of the error.

５） ＱＡＰ ＭＡＴＲＩＸ
全体の平均値を中心にして±３ＳＤを外枠にし、±１ＳＤを点線で区切った基盤の中に、キーコードで分類した自施設と同じグループの平均値±２ＳＤ枠を太黒線で描いた（表１８）。自施設のデータは、全体の平均値から２試料ともに±１ＳＤ以内の場合は青●でプロットし、１試料でも±１ＳＤを超えた場合は赤●でプロットされる。図中ＺＴＴ、ＣＫ、ＡＭＹの場合が赤●で他は青●である。

5) QAP MATRIX
The average value ± 2SD frame of the same group as the own facility classified by the key code is drawn with a thick black line in the base with ± 3SD as the outer frame centered on the whole average value and ± 1SD separated by a dotted line (Table 18). The data of the institution is plotted in blue ● when both samples are within ± 1SD from the average value of the whole, and in red ● if even one sample exceeds ± 1SD. In the figure, ZTT, CK, and AMY are red and others are blue.

６）オプション設定
管理試料のロット番号を指定または変更がおこなえ、集計の分類キーコードの選択を行える。キーコードを一覧より選択する。同一施設複数台で利用もしくはグループ施設で利用の場合は、「他施設プロット」を「する」にマークし、他施設コードリストで他施設の施設コードを入力し、追加・更新する。複数の施設コードの登録が行える。ＱＡＰ管理図、ＴＷＩＮ ＰＬＯＴ、ＱＡＰ ＭＡＴＲＩＸに複数台または複数施設データを同時にプロットしたい場合に使用する。ここで登録した施設コードは（○）でプロットされる。
７）グループ集計閲覧
全国平均値とは別に、グループ施設の集計値を基に各種の管理図を閲覧する場合は、以下の手順となる。なお、グループ集計を希望する場合は、予め申し込みおこなう。（１）「施設データファイル」の選択は通常と同じ手順で行う。（２）「集計データファイル」の選択は、「変更」ボタンを押して、ＣＤ−ＲＯＭ内の「ＱＡＰＶｉｅｗ」フォルダーをダブルクリックし、次にその中にある「ｄａｔａｆｉｌｅ」フォルダーをダブルクリックし、さらにその中にある「グループファイル」フォルダーをダブルクリックして、＊＊＊＊２３０Ｘ．ｅｑｃ（グループ施設データファイル）を選択し、「開く」をクリックして行う。＊＊＊＊はグループ毎にファイル名が異なる。（３）「他施設プロット」を「する」にマークし、他施設コードリストで他施設の施設コードを入力し、追加・更新する。ＱＡＰ管理図、ＴＷＩＮ ＰＬＯＴ、ＱＡＰ ＭＡＴＲＩＸに複数施設データを同時にプロットできる。ここで登録した施設コードは（○）でプロットされる。

6) Option setting The lot number of the control sample can be specified or changed, and the classification key code can be selected. Select the key code from the list. When using the same facility for multiple units or group facilities, mark “Other facility plot” as “Yes”, enter the facility code of the other facility in the other facility code list, and add / update. Multiple facility codes can be registered. Use this when you want to plot data for multiple units or multiple facilities simultaneously on a QAP chart, TWIN PLOT, or QAP MATRIX. The facility codes registered here are plotted with (o).
7) Group tabulation browsing The following procedure is used when browsing various control charts based on group facility tabulation values, apart from the national average. If you wish to collect groups, apply in advance. (1) The “facility data file” is selected by the same procedure as usual. (2) To select “Aggregate data file”, click the “Change” button, double-click the “QAPView” folder in the CD-ROM, then double-click the “datafile” folder in it, Double-click the “Group File” folder in the folder, and then click *** 230X. Select eqc (group facility data file) and click “Open”. ****** has a different file name for each group. (3) Mark “Other facility plot” as “Yes”, enter the facility code of the other facility in the other facility code list, and add / update. Multiple facility data can be plotted simultaneously on the QAP chart, TWIN PLOT, and QAP MATRIX. The facility codes registered here are plotted with (o).

  Thus, the system of the present invention makes it possible to provide high objectivity and reliability in clinical examinations, and achieve an accuracy guarantee appropriate for examination information.

FIG. 1 shows an overall conceptual diagram of the present invention, and shows the relationship between each facility and a center that aggregates and analyzes data obtained from each facility. FIG. 2 shows a registration application for participation in the system of the present invention. FIG. 3 is an example of a report provided from the center to each facility.

Claims (7)

The measurement data obtained by measuring quality control samples with clinical laboratory analyzers are collected on the server from the facility terminals via the Internet, and the server collects lot numbers for the measurement data collected from each facility . Data that has been determined to be abnormal by performing an error check that includes determining whether the license is valid, whether it is within the expiration date, and whether the facility code is registered The total of the measurement data is excluded, and the average value and standard deviation of the measurement data are obtained as monthly statistical data related to external quality control, and the measurement data of the facility and the total average value ± 2 standard deviations A control chart showing the relationship is created, and monthly statistical data related to external quality control including the control chart is distributed to the facility terminals via the Internet. Quality control method to. 2. The quality control method according to claim 1, wherein the control chart is a control chart in which facility measurement data is plotted and a frame of an overall average value ± 2 standard deviations is displayed. 3. The accuracy management method according to claim 2, wherein the control chart is a control chart in which a frame of an overall average value ± 3 standard deviations is further displayed. The quality control method according to any one of claims 1 to 3, wherein the control chart is a management chart of measurement data of two types of quality control samples having different concentrations. 5. The quality control method according to claim 1, wherein the server stores the control chart so as to be downloadable via the Internet by browser software installed in a terminal of a facility. The server is obtained by measuring a quality control sample with an analytical instrument in a facility other than the facility, and performs totalization of measurement data received by mail or facsimile and measurement data collected via the Internet, and quality control method according to any one of claim 1 to 5, wherein the determination of the monthly statistics on quality control. The quality control method according to any one of claims 1 to 6 , wherein the server collects measurement data transferred by file transfer software installed in a terminal of the facility.

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