CN108109675A - A kind of Good Laboratory controls data management system - Google Patents
A kind of Good Laboratory controls data management system Download PDFInfo
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- CN108109675A CN108109675A CN201611049941.XA CN201611049941A CN108109675A CN 108109675 A CN108109675 A CN 108109675A CN 201611049941 A CN201611049941 A CN 201611049941A CN 108109675 A CN108109675 A CN 108109675A
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Abstract
The invention discloses a kind of Good Laboratories to control data management system, including：For gathering the quality control data collecting unit of quality control determination data in laboratory, for carrying out the statistic unit of equal Data-Statistics according to the quality control data of accumulation acquisition, for formulating the scaling unit of the acceptable error standard Tea of respective item according to project relevant regulations, for the image-drawing unit according to average statistical and acceptable error standard TEa generation loudspeaker figures, for intersecting the arithmetic element of acquisition intersection point according to the determination data generation respective graphical currently collected and with loudspeaker figure, for showing that laboratory system error is subjected to the limit of new range and encloses unit according to the intersection point of acquisition, for being subjected to the analytic unit that new range analyzes the determination data of quality control in the laboratory that collects according to laboratory system error.Available data is analyzed, narrower overall error tolerance interval is obtained, without refusing all sample results, efficent use of resources.
Description
Technical field
The present invention relates to Quality Control Technology field more particularly to a kind of Good Laboratory control data management systems.
Background technology
Quality control (abbreviation Quality Control) is very crucial in clinical labororatory；At present for clinical labororatory's detection error
Assessment is substantially for single-point (single concentration level).But actually detected concentration is a section.But it if is directed to
The error evaluation of one continuum is very cumbersome, is not suitable for the routine work of clinical labororatory.Therefore in a normal state,
Clinical labororatory can not overall monitor itself detection error, this can bring very big risk to patient.For undertaking conventional inspection
The clinical labororatory of work is surveyed, according to national standard (the indoor quality control of GB/T 20468-2006 clinical labororatories quantitative determination
Guide) it needs to establish corresponding Quality Control Procedure, while have accumulated corresponding quality control data and (range of linearity and can connect total
Error has obtained in routine duties).Although laboratory has had accumulated above-mentioned data, these data are largely
It is not used effectively and analyzes.Cause laboratory not good to the mean error of existing error and a special time period
Estimation and grasp.In clinical labororatory's general measure detection, first-order linear is presented in detection data within the specific limits.The scope
It obtains in routine duties.Preparation method is substantially：On the premise of no systematic error, the inspection in a certain detection range
Difference (cause difference is random error or the detectable limit of the detection method) between measured data and truthful data is can
Receive in the range of overall error.However the actual situation is that systematic error is eternal existing.It is each in the entire range of linearity
Different concentration points there will necessarily be error, and error size is different.Caused by this systematic error by that can not eliminate
Error, present first-order linear.This means in some smaller concentration range in the known range of linearity, error is still
Can so it receive (shortening for being equivalent to the range of linearity).Clinical labororatory, it is linear when due to being unable to estimate systematic error
Scope generally all refuses the experimental result in gamut to detect all samples again after, it is necessary to correct the systematic error.
And it is acceptable still to have the error of significant portion of sample institute band among these.This will cause huge time and resource
Waste.
The content of the invention
In view of presently, there are above-mentioned deficiency, the present invention provides a kind of Good Laboratory control data management system, can
Quality Control data is made to be utilized effectively and analyze.
In order to achieve the above objectives, the embodiment of the present invention adopts the following technical scheme that：
A kind of Good Laboratory controls data management system, and the Good Laboratory control data management system includes：With
In the quality control data collecting unit of quality control determination data in acquisition laboratory, for the quality according to accumulation acquisition
Data is controlled to carry out the statistic unit of equal Data-Statistics, for formulating the acceptable error mark of respective item according to project relevant regulations
The scaling unit of quasi- Tea for the image-drawing unit according to average statistical and acceptable error standard TEa generation loudspeaker figures, is used for
Intersect the arithmetic element of acquisition intersection point according to the determination data generation respective graphical currently collected and with loudspeaker figure, for basis
The intersection point of acquisition show that laboratory system error is subjected to the limit of new range and encloses unit, for that can be connect according to laboratory system error
The analytic unit analyzed by new range the determination data of quality control in the laboratory that collects.
According to one aspect of the present invention, the quality control data collecting unit includes manual entry device and data are led
Incoming interface.
According to one aspect of the present invention, the statistic unit includes changing statistics list between Internal Quality Control statistic unit and room
Member.
According to one aspect of the present invention, the image-drawing unit includes coordinate system generation unit and described point unit.
According to one aspect of the present invention, the analytic unit includes determining whether unit and processing unit, and identifying unit is used for
Be measured the judgement of data sample and acceptable new range, processing unit be used for according to judging result determine the use of sample with
It is no.
The advantages of present invention is implemented：Good Laboratory of the present invention controls data management system, including：For gathering
The quality control data collecting unit of quality control determination data in laboratory, for the quality control number according to accumulation acquisition
According to the statistic unit for carrying out equal Data-Statistics, for formulating the acceptable error standard Tea of respective item according to project relevant regulations
Scaling unit, for according to average statistical and acceptable error standard TEa generation loudspeaker figure image-drawing unit, for according to work as
Before collect determination data generation respective graphical and intersect with loudspeaker figure obtain intersection point arithmetic element, for according to acquisition
Intersection point show that laboratory system error is subjected to the limit of new range and encloses unit, for being subjected to new model according to laboratory system error
Enclose the analytic unit analyzed the determination data of quality control in the laboratory that collects.By according to the rules formulating
On acceptable error standard, amount determines the new acceptable error range of linearity again, so that formulating acceptable miss original
Quality Control data outside poor standard can obtain the chance once judged again, and therefore, some are in new acceptable error scope
Interior Quality Control data will not be rejected, and obtain effective utilization and analysis, further such that quality control effect in laboratory
It is more accurate, reduce the consumption of time, avoid waste of resource.One analysis method for efficiently using available data is provided.It is depositing
In the case of systematic error, available data is analyzed, obtains an acceptable temporary range of narrower overall error.
Testing result in the range of this is can to meet overall error requirement (country or professional standard), and received, without refusing
Exhausted all sample results, efficent use of resources.
Description of the drawings
It to describe the technical solutions in the embodiments of the present invention more clearly, below will be to needed in the embodiment
Attached drawing is briefly described, it should be apparent that, the accompanying drawings in the following description is only some embodiments of the present invention, for ability
For the those of ordinary skill of domain, without creative efforts, it can also be obtained according to these attached drawings other attached
Figure.
Fig. 1 controls data management system schematic diagram for a kind of Good Laboratory of the present invention.
Specific embodiment
Below in conjunction with the attached drawing in the embodiment of the present invention, the technical solution in the embodiment of the present invention is carried out clear, complete
Site preparation describes, it is clear that described embodiment is only part of the embodiment of the present invention, instead of all the embodiments.It is based on
Embodiment in the present invention, those of ordinary skill in the art are obtained every other without making creative work
Embodiment belongs to the scope of protection of the invention.
As shown in Figure 1, a kind of Good Laboratory control data management system, the Good Laboratory control data management system
System includes：For gathering the quality control data collecting unit 1 of quality control determination data in laboratory, for being adopted according to accumulation
The quality control data of collection carries out the statistic unit 2 of equal Data-Statistics, for formulating respective item according to project relevant regulations
The scaling unit 3 of acceptable error standard Tea, for generating loudspeaker figure according to average statistical and acceptable error standard TEa
Image-drawing unit 4, for intersecting the fortune of acquisition intersection point according to the determination data generation respective graphical currently collected and with loudspeaker figure
Unit 5 is calculated, for showing that laboratory system error is subjected to the limit of new range and encloses unit 6 according to the intersection point of acquisition, for basis
Laboratory system error is subjected to the analysis that new range analyzes the determination data of quality control in the laboratory that collects
Unit 7.
Wherein, the quality control data collecting unit 1 includes manual entry device 11 and data introducting interface 12；In reality
In the application of border, the manual entry device is keyboard, and user controls data by keyboard craft input quality.In practical application
In, the data introducting interface can be LIS data-interfaces, be imported Quality Control data by Laboratory Information Management System (LIS)
Data management system is controlled to Good Laboratory.
Wherein, the statistic unit 2 includes changing statistic unit 22 between Internal Quality Control statistic unit 21 and room.
Wherein, the image-drawing unit 4 includes coordinate system generation unit 41 and described point unit 42.
Wherein, the analytic unit 7 includes determining whether unit 71 and processing unit 72, and identifying unit is used to be measured data
The judgement of sample and acceptable new range, whether processing unit is used to determine the use of sample according to judging result.
In practical applications, including mode is implemented as follows：
Gather the determination data of quality control in laboratory；
Indoor quality control is carried out by relevant national standard, and gathers determination data, at least once a day, every time at least
Gather two data；The data of accumulation are more, and error interval estimation is more accurate.For example, in a certain purpose room of labs
Quality Control scheme is with reference to GB/T 20468-2006《The indoor quality control guide of clinical labororatory's quantitative determination》Carry out Internal Quality Control.
Independent third party's Quality Control object of 2 concentration levels is used daily and is respectively detected once, Quality Control initial data such as following table：
| Quality Control is horizontal | The Quality Control time | Quality Control result |
| 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 |
Equal Data-Statistics are carried out according to the quality control data of accumulation；
Quality Control data are counted, including changing statistics between Internal Quality Control statistics and Internal Quality Control room, statistic is：
Value.
The acceptable error standard TEa of respective item is formulated according to project relevant regulations；
The acceptable error standard TEa of each project is formulated according to national regulation, that is, is acceptable between the two
Error level.The scope is determined that overall error derives from national standard or professional standard by overall error.
According to average statistical and acceptable error standard TEa generation loudspeaker figures；
Using average statistical as transverse axis, practical measurement numerical value is the longitudinal axis, forms coordinate system, and by acceptable error standard TEa
It carries out drawing in a coordinate system and forms loudspeaker figure.
In practical applications, it is assumed that transverse axis is X-axis, and the longitudinal axis is Y-axis, then can define straight line is y=x, and representative is
Perfect condition equal with average statistical x current detection value y, and because the eternal presence of systematic error, then with good grounds system is missed
The acceptable error standard TEa that difference is formed, so as to form two horn-like rays in a coordinate system.
According to the determination data generation respective graphical currently collected and intersect acquisition intersection point with loudspeaker figure；
In the Quality Control detected value or the Quality Control detected value of certain time period for generating a certain moment where loudspeaker figure on coordinate system
Average, according to national standard, at least the Quality Control data point there are 2 concentration；It is fitted further according to the single order that Quality Control data point obtains
Curve intersects acquisition intersection point according to the curve with loudspeaker figure.
In practical applications, when only existing two data points, two points is connected and are extended and loudspeaker figure intersects,
Obtain intersection point.
In practical applications, when there are the first-order linear regression equation that these points during the data point of 2 or more, are obtained, pictures
Go out after this graph of equation shape and loudspeaker figure intersects and obtains intersection point.
Show that laboratory system error is subjected to new range according to the intersection point of acquisition；
Calculate intersecting point coordinate, the closed interval that acceptable error scope then forms for the ordinate value of two intersecting point coordinates.
According to laboratory system error be subjected to new range to the determination data of quality control in the laboratory that collects into
Row analysis.
If the determination data sample of quality control in the laboratory collected is located in acceptable new range section, optional
With；Otherwise determination data sample is refused.
In practical applications, can the instantaneous new range of linearity be estimated according to the conversion of horizontally and vertically data, is worked as with providing
The foundation of preceding determination data sample process decision-making.
In practical applications, can the average linear scope in a period of time be estimated according to the conversion of horizontally and vertically data,
It is summarized with carrying out retrospective control errors.
The advantages of present invention is implemented：Good Laboratory of the present invention controls data management system, including：For gathering
The quality control data collecting unit of quality control determination data in laboratory, for the quality control number according to accumulation acquisition
According to the statistic unit for carrying out equal Data-Statistics, for formulating the acceptable error standard Tea of respective item according to project relevant regulations
Scaling unit, for according to average statistical and acceptable error standard TEa generation loudspeaker figure image-drawing unit, for according to work as
Before collect determination data generation respective graphical and intersect with loudspeaker figure obtain intersection point arithmetic element, for according to acquisition
Intersection point show that laboratory system error is subjected to the limit of new range and encloses unit, for being subjected to new model according to laboratory system error
Enclose the analytic unit analyzed the determination data of quality control in the laboratory that collects.By according to the rules formulating
On acceptable error standard, amount determines the new acceptable error range of linearity again, so that formulating acceptable miss original
Quality Control data outside poor standard can obtain the chance once judged again, and therefore, some are in new acceptable error scope
Interior Quality Control data will not be rejected, and obtain effective utilization and analysis, further such that quality control effect in laboratory
It is more accurate, reduce the consumption of time, avoid waste of resource.One analysis method for efficiently using available data is provided.It is depositing
In the case of systematic error, available data is analyzed, obtains an acceptable temporary range of narrower overall error.
Testing result in the range of this is can to meet overall error requirement (country or professional standard), and received, without refusing
Exhausted all sample results, efficent use of resources.
The above description is merely a specific embodiment, but protection scope of the present invention is not limited thereto, any
Those skilled in the art is in technical scope disclosed by the invention, the change or replacement that can readily occur in, all should
It is included within the scope of the present invention.Therefore, protection scope of the present invention should using the scope of the claims as
It is accurate.
Claims (5)
1. a kind of Good Laboratory controls data management system, which is characterized in that the Good Laboratory control data management system
System includes：For gathering the quality control data collecting unit of quality control determination data in laboratory, for being adopted according to accumulation
The quality control data of collection carries out the statistic unit of equal Data-Statistics, for according to project relevant regulations formulate respective item can
Receive the scaling unit of error criterion Tea, for the drawing according to average statistical and acceptable error standard TEa generation loudspeaker figures
Unit, for intersecting the computing list of acquisition intersection point according to the determination data generation respective graphical currently collected and with loudspeaker figure
Member, for showing that laboratory system error is subjected to the limit of new range and encloses unit according to the intersection point of acquisition, for according to laboratory
Systematic error is subjected to the analytic unit that new range analyzes the determination data of quality control in the laboratory that collects.
2. Good Laboratory according to claim 1 controls data management system, which is characterized in that the quality control number
Include manual entry device and data introducting interface according to collecting unit.
3. Good Laboratory according to claim 1 controls data management system, which is characterized in that the statistic unit bag
It includes and changes statistic unit between Internal Quality Control statistic unit and room.
4. Good Laboratory according to claim 1 controls data management system, which is characterized in that the image-drawing unit bag
Include coordinate system generation unit and described point unit.
5. the Good Laboratory control data management system according to one of Claims 1-4, which is characterized in that described point
Analysis unit includes determining whether unit and processing unit, and identifying unit is used to being measured sentencing for data sample and acceptable new range
It is disconnected, whether processing unit is used to determine the use of sample according to judging result.
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Cited By (2)
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| CN109030803A (en) * | 2018-06-15 | 2018-12-18 | 浙江省人民医院 | Biochemistry detection quality control method |
| CN109036497A (en) * | 2018-07-24 | 2018-12-18 | 上海昆涞生物科技有限公司 | A kind of analysis method and device of medical laboratory's testing result |
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