CN108109675B - Laboratory quality control data management system - Google Patents

Laboratory quality control data management system Download PDF

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CN108109675B
CN108109675B CN201611049941.XA CN201611049941A CN108109675B CN 108109675 B CN108109675 B CN 108109675B CN 201611049941 A CN201611049941 A CN 201611049941A CN 108109675 B CN108109675 B CN 108109675B
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quality control
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laboratory
control data
horn
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CN108109675A (en
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周之炜
程伟志
张国立
范勇辉
李玉君
张强
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Shanghai Qualab Biotechnology Co ltd
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Abstract

The invention discloses a laboratory quality control data management system, which comprises: the device comprises a quality control data acquisition unit for acquiring quality control measurement data in a laboratory, a statistical unit for carrying out mean value statistics according to the cumulatively acquired quality control data, a calibration unit for formulating an acceptable error standard TEa of a corresponding project according to related regulations of the project, a drawing unit for generating a horn diagram according to the statistical mean value and the acceptable error standard TEa, an operation unit for generating a corresponding diagram according to the currently acquired measurement data and intersecting the horn diagram to obtain an intersection point, a limit unit for obtaining an acceptable new range of laboratory system errors according to the obtained intersection point, and an analysis unit for analyzing the acquired measurement data of the quality control in the laboratory according to the acceptable new range of the laboratory system errors. The existing data are analyzed to obtain a narrower acceptable range of total errors, all sample results do not need to be rejected, and resources are effectively utilized.

Description

Laboratory quality control data management system
Technical Field
The invention relates to the technical field of quality control, in particular to a laboratory quality control data management system.
Background
Quality control (quality control for short) is critical in clinical laboratories; currently, clinical laboratory detection errors are evaluated for essentially a single point (single concentration level). But the actually detected concentration is an interval. But if the error evaluation for a continuous interval is very cumbersome it is not suitable for routine work in a clinical laboratory. Therefore, under the conventional condition, the clinical laboratory cannot fully monitor the detection error of the clinical laboratory, which brings great risk to the patient. For the clinical laboratory which undertakes the routine detection work, a corresponding quality control program needs to be established according to the national standard (GB/T20468-. While laboratories have accumulated the above data, the data is largely inefficiently utilized and analyzed. Resulting in the laboratory not having a good estimate and grasp of the existing errors and the average error for a particular time period. In routine quantitative detection in a clinical laboratory, detection data presents first-order linearity in a certain range. This range has also been achieved in everyday work. The essence of the obtaining method is as follows: the difference between the detected data and the real data within a certain detection range (whether random error or detection limit of the detection method results in the difference) is within an acceptable total error range without systematic error. However, in practice, systematic errors are ever present. At each different concentration point in the whole linear range, there must be an error, and the error magnitude is different. This error, caused by systematic errors that cannot be eliminated, exhibits first order linearity. This means that in a certain smaller concentration range within the known linear range, the error is still acceptable (corresponding to a shortening of the linear range). In a clinical laboratory, since the linear range with system errors cannot be estimated, all experimental results in the whole range are generally rejected, and all samples need to be re-detected after the system errors are corrected. And still a significant portion of the sample with acceptable errors. This results in a huge waste of time and resources.
Disclosure of Invention
In view of the above-mentioned shortcomings, the present invention provides a laboratory quality control data management system that enables quality control data to be effectively utilized and analyzed.
In order to achieve the above purpose, the embodiment of the invention adopts the following technical scheme:
a laboratory quality control data management system, the laboratory quality control data management system comprising: the device comprises a quality control data acquisition unit for acquiring quality control measurement data in a laboratory, a statistical unit for carrying out mean value statistics according to the cumulatively acquired quality control data, a calibration unit for formulating an acceptable error standard TEa of a corresponding project according to related regulations of the project, a drawing unit for generating a horn diagram according to the statistical mean value and the acceptable error standard TEa, an operation unit for generating a corresponding diagram according to the currently acquired measurement data and intersecting the horn diagram to obtain an intersection point, a limit unit for obtaining an acceptable new range of laboratory system errors according to the obtained intersection point, and an analysis unit for analyzing the acquired measurement data of the quality control in the laboratory according to the acceptable new range of the laboratory system errors.
According to one aspect of the invention, the quality control data acquisition unit comprises a manual entry device and a data import interface.
According to one aspect of the invention, the statistical unit comprises an indoor quality control statistical unit and an indoor compartmentalization statistical unit.
According to an aspect of the invention, the drawing unit comprises a coordinate system generating unit and a dotting unit.
According to one aspect of the invention, the analysis unit comprises a determination unit for making a determination of the measured data sample and the acceptable new range, and a processing unit for deciding the adoption or non-adoption of the sample based on the determination result.
The implementation of the invention has the advantages that: the invention relates to a laboratory quality control data management system, which comprises: the device comprises a quality control data acquisition unit for acquiring quality control measurement data in a laboratory, a statistical unit for carrying out mean value statistics according to the cumulatively acquired quality control data, a calibration unit for formulating an acceptable error standard TEa of a corresponding project according to related regulations of the project, a drawing unit for generating a horn diagram according to the statistical mean value and the acceptable error standard TEa, an operation unit for generating a corresponding diagram according to the currently acquired measurement data and intersecting the horn diagram to obtain an intersection point, a limit unit for obtaining an acceptable new range of laboratory system errors according to the obtained intersection point, and an analysis unit for analyzing the acquired measurement data of the quality control in the laboratory according to the acceptable new range of the laboratory system errors. The new linear range of the acceptable error is measured again on the basis of the standard of the acceptable error which is set according to the regulations, so that the quality control data outside the original set standard of the acceptable error can obtain the chance of judging again, therefore, some quality control data in the new range of the acceptable error can not be rejected, effective utilization and analysis are obtained, the quality control effect in a laboratory is further more accurate, the time consumption is reduced, and the waste of resources is avoided. An analysis method is provided which efficiently utilizes existing data. In the case of systematic errors, the existing data are analyzed to obtain a narrower temporal range acceptable for the total error. The detection result in the range can meet the total error requirement (national or industrial standard), and is accepted, all sample results are not required to be rejected, and resources are effectively utilized.
Drawings
In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the drawings needed to be used in the embodiments will be briefly described below, and it is obvious that the drawings in the following description are only some embodiments of the present invention, and it is obvious for those skilled in the art that other drawings can be obtained according to these drawings without creative efforts.
FIG. 1 is a schematic diagram of a laboratory quality control data management system according to the present invention.
Detailed Description
The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
As shown in fig. 1, a laboratory quality control data management system, comprising: the device comprises a quality control data acquisition unit 1 for acquiring quality control measurement data in a laboratory, a statistical unit 2 for carrying out mean value statistics according to the cumulatively acquired quality control data, a calibration unit 3 for formulating an acceptable error standard TEA of a corresponding project according to related regulations of the project, a drawing unit 4 for generating a horn diagram according to the statistical mean value and the acceptable error standard TEA, an operation unit 5 for generating a corresponding diagram according to the currently acquired measurement data and intersecting the horn diagram to obtain an intersection point, a bounding unit 6 for obtaining an acceptable new range of laboratory system errors according to the obtained intersection point, and an analysis unit 7 for analyzing the acquired measurement data of the quality control in the laboratory according to the acceptable new range of the laboratory system errors.
The quality control data acquisition unit 1 comprises a manual entry device 11 and a data import interface 12; in practical application, the manual entry device is a keyboard, and a user manually inputs quality control data through the keyboard. In practical application, the data import interface may be an LIS data interface, and the quality control data is imported to a laboratory quality control data management system through a laboratory information management system (LIS).
Wherein, the statistical unit 2 comprises an indoor quality control statistical unit 21 and an indoor compartmentalization statistical unit 22.
Wherein the drawing unit 4 comprises a coordinate system generating unit 41 and a point drawing unit 42.
The analysis unit 7 includes a determination unit 71 for determining whether the measured data sample and the acceptable new range are available, and a processing unit 72 for determining whether the sample is available or not according to the determination result.
In practical application, the following embodiments are included:
collecting the measurement data of quality control in a laboratory;
performing indoor quality control according to related national standards, and collecting measured data at least once a day, and collecting at least two data each time; the more data is accumulated, the more accurate the error interval estimation is. For example, an indoor quality control scheme for a certain project developed in a laboratory refers to GB/T20468-. That is, independent third-party quality control substances with 2 concentration levels are used every day and are detected once, and the quality control raw data are as follows:
level of quality control Time of quality control Quality control results
Level
1 2016-3-1 08:58 12.6
Level 2 2016-3-1 08:58 27.5
Level 1 2016-3-2 10:44 12.9
Level 2 2016-3-2 10:44 29.2
Level 1 2016-3-3 08:51 12.9
Level 2 2016-3-3 08:51 25.8
Level 1 2016-3-4 09:08 13.4
Level 2 2016-3-4 09:08 25.8
Level 1 2016-3-7 09:05 13.4
Level 2 2016-3-7 09:05 30
Level 1 2016-3-8 08:53 12.7
Level 2 2016-3-8 08:53 27.9
Level 1 2016-3-9 08:45 13.1
Level 2 2016-3-9 08:45 27.2
Level 1 2016-3-10 08:31 13.3
Level 2 2016-3-10 08:31 28.1
Level 1 2016-3-11 09:14 13
Level 2 2016-3-11 09:14 28.2
Level 1 2016-3-14 08:41 13
Level 2 2016-3-14 08:41 28.5
Level 1 2016-3-15 08:31 12.9
Level 2 2016-3-15 08:31 27
Carrying out mean value statistics according to the accumulated quality control data;
the quality control data are counted, wherein the statistics comprises indoor quality control statistics and indoor quality control room compartmentalization statistics, and the statistics is as follows: and (4) average value.
Making an acceptable error standard TEa of a corresponding project according to related provisions of the project;
the acceptable error criterion, TEa, is established for each project according to national regulations, i.e. an acceptable error level between the two. The range is determined by the total error, which is derived from national or industry standards.
Generating a horn diagram according to the statistical mean and the acceptable error standard TEa;
and forming a coordinate system by taking the statistical mean as a horizontal axis and the actual measured value as a vertical axis, and drawing the acceptable error standard TEa in the coordinate system to form a horn diagram.
In practical applications, assuming that the horizontal axis is X axis and the vertical axis is Y axis, a straight line may be defined as Y ═ X, which represents an ideal state that the current detection value Y is equal to the statistical mean value X, and because of the permanent existence of the systematic error, the acceptable error criterion TEa formed according to the systematic error forms two trumpet-shaped rays in the coordinate system.
Generating a corresponding graph according to the currently acquired measurement data and intersecting the corresponding graph with the horn graph to obtain an intersection point;
generating a quality control detection value at a certain moment or a mean value of the quality control detection values in a certain time period on a coordinate system where the horn image is located, wherein at least 2 quality control data points with concentration exist according to national standards; and then obtaining a first-order fitting curve according to the quality control data points, and intersecting the horn diagram according to the first-order fitting curve and obtaining an intersection point.
In practical applications, when there are only two data points, the two points are connected and elongated, intersecting the horn pattern, to obtain an intersection point.
In practical application, when more than 2 data points exist, a first-order linear regression equation of the data points is obtained, and after a graph of the equation is drawn, the equation is intersected with a horn graph to obtain an intersection point.
Obtaining an acceptable new range of the error of the laboratory system according to the obtained intersection points;
and calculating the coordinates of the intersection points, wherein the acceptable error range is a closed interval formed by longitudinal coordinate values of the coordinates of the two intersection points.
And analyzing the collected measurement data of the quality control in the laboratory according to the new acceptable error range of the laboratory system.
If the collected measured data sample of the quality control in the laboratory is positioned in the acceptable new range interval, the sample can be selected; otherwise, the assay data sample is rejected.
In practical applications, the new linear range of the instant can be estimated based on the transformation of the horizontal axis and the vertical axis data to provide the basis for the processing decision of the current measured data sample.
In practical applications, the average linear range over a period of time may be estimated based on the transformation of the horizontal and vertical axis data for retrospective error control summarization.
The implementation of the invention has the advantages that: the invention relates to a laboratory quality control data management system, which comprises: the device comprises a quality control data acquisition unit for acquiring quality control measurement data in a laboratory, a statistical unit for carrying out mean value statistics according to the cumulatively acquired quality control data, a calibration unit for formulating an acceptable error standard TEa of a corresponding project according to related regulations of the project, a drawing unit for generating a horn diagram according to the statistical mean value and the acceptable error standard TEa, an operation unit for generating a corresponding diagram according to the currently acquired measurement data and intersecting the horn diagram to obtain an intersection point, a limit unit for obtaining an acceptable new range of laboratory system errors according to the obtained intersection point, and an analysis unit for analyzing the acquired measurement data of the quality control in the laboratory according to the acceptable new range of the laboratory system errors. The new linear range of the acceptable error is measured again on the basis of the standard of the acceptable error which is set according to the regulations, so that the quality control data outside the original set standard of the acceptable error can obtain the chance of judging again, therefore, some quality control data in the new range of the acceptable error can not be rejected, effective utilization and analysis are obtained, the quality control effect in a laboratory is further more accurate, the time consumption is reduced, and the waste of resources is avoided. An analysis method is provided which efficiently utilizes existing data. In the case of systematic errors, the existing data are analyzed to obtain a narrower temporal range acceptable for the total error. The detection result in the range can meet the total error requirement (national or industrial standard), and is accepted, all sample results are not required to be rejected, and resources are effectively utilized.
The above description is only an embodiment of the present invention, but the scope of the present invention is not limited thereto, and any changes or substitutions that can be easily conceived by those skilled in the art within the technical scope of the present invention disclosed herein are intended to be covered by the scope of the present invention. Therefore, the protection scope of the present invention shall be subject to the protection scope of the appended claims.

Claims (4)

1. A laboratory quality control data management system, comprising: a quality control data acquisition unit for acquiring quality control measurement data in a laboratory; the statistical unit is used for carrying out mean value statistics according to the cumulatively collected quality control data; a scaling unit for formulating an acceptable error criterion, TEa, of the respective item according to an item-related specification; the drawing unit is used for generating a horn diagram according to the statistical mean and the acceptable error standard TEa, the drawing unit comprises a coordinate system generating unit and a point drawing unit, the horn diagram takes the statistical mean as a horizontal axis and an actual measured value as a vertical axis to form a coordinate system, and two rays forming a horn shape are drawn in the coordinate system according to the acceptable error standard TEa formed by the system error; the calculation unit is used for generating a corresponding graph according to the currently acquired measurement data and intersecting the horn diagram to obtain an intersection point, and the generation of the corresponding graph according to the currently acquired measurement data and intersecting the horn diagram to obtain the intersection point is specifically that a quality control detection value at a certain moment or a mean value of the quality control detection values in a certain time period is generated on a coordinate system where the horn diagram is located, at least 2 quality control data points with concentration exist according to national standards, and then a first-order fitting curve is obtained according to the quality control data points, and the intersection point is obtained according to the intersection of the curve and the horn diagram; the limit unit is used for obtaining a new acceptable error range of the laboratory system according to the obtained intersection points; and the analysis unit is used for analyzing the collected measurement data of the quality control in the laboratory according to the new acceptable error range of the laboratory system.
2. The laboratory quality control data management system of claim 1, wherein said quality control data acquisition unit comprises a manual entry device and a data import interface.
3. The laboratory quality control data management system of claim 1, wherein said statistical unit comprises an indoor quality control statistical unit and an indoor compartmentalization statistical unit.
4. The laboratory quality control data management system according to one of claims 1 to 3, wherein the analysis unit includes a determination unit for making a determination of the measured data sample and the acceptable new range, and a processing unit for deciding whether the sample is adopted or not based on the determination result.
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CN109030803B (en) * 2018-06-15 2021-07-27 浙江省人民医院 Biochemical detection quality control method
CN109036497B (en) * 2018-07-24 2021-04-23 上海昆涞生物科技有限公司 Method and device for analyzing detection result of medical laboratory

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