CN103097864A - A method and system for managing analytical quality in networked laboratories - Google Patents
A method and system for managing analytical quality in networked laboratories Download PDFInfo
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- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
- G01N35/00584—Control arrangements for automatic analysers
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- G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
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Abstract
A quality performance measure is derived from instrumentation test values compared with expected values and population values. A model for determining acceptance for quality performance is developed and evaluated. Systems and methods implemented in an instrument network with software automatically collects test data for quality measurement. The test data is collected centrally and formatted for use with various outputs. Calculations are performed on the test data to determine compliance with established quality measures. The results can be displayed in tabulated or graphical format.
Description
Background technology
The pathology service improvement of the availability of the sensitive medical science instrument by be used for carrying out medical analysis in recent years, be used for the option of accelerating in pathology service source and by realizing that laboratory network is benefited with the system integration of the transferability that allows the patient data.The benefit of these progress of pathology service is also for the clinician provides the treatment patient benefit of aspect, and this treatment may be the result driving by the test of carrying out on the medical science instrument sometimes.Seek the lasting improvement of patient care by the patient data's that laboratory practice standardization between different medical laboratories allowed increase transferability.
The coordination of existence in the laboratory-rather than standardization-trend, and in some zone, have the expectation of seeing more laboratory networks.These measure intentions promote the health care of distributed form more, but probably will apply the additional load that the data transferability is provided to the laboratory quality.The concern of patient data's transferability has been indicated the expectation that is more tightly controlled that is used for analyzing quality.
Defined many quality requirementss in the past 30 years are analyzed the specifications of quality in order to set up.In 1999, the international conference in Stockholm " Strategies to set global analytical quality specifications in laboratory medicine " caused the consistent agreement of definition for the hierarchy of the model of determining the analysis quality.In the situation that available, and when being suitable for desired use, be preferred at model higher in hierarchy for those of reduced levels place.Two the highest model description based on the standard of clinical requirement with change the norm of analysis of (biological variation) based on biology.The highest model probably is regarded as the best way, and standard is relevant to clinical effectiveness because it makes expectation.Yet model is in fact because the definition strategy that improves that lacks for each test is difficult to derive evaluating objects.Even have strategy, the mode that also is difficult to express with quantitative term use test in clinical settings.In addition, use in a different manner lab investigation in different clinical settingses; The standard that derives from the analysis of a situation may be not suitable for other situation.
Making the laboratory practice standardization is the analysis variability that reduces between instrument and/or laboratory with the key concept that to be used for medical science test consistent results aspect.Owing to sometimes can improving patients clinical nursing by transporting patient between the main nursing facility in different hospitals or network, so patient data's transferability is that to keep high-quality nursing level aspect be key factor.Patient data's transferability contains the concept of testing relevant accurate and consistent result from the patient from different analytical instrument or laboratory acquisition.That is to say, if the patient data will be transferable, should be from different analytical instrument and/or laboratory or the pathology service network obtain to be used for equal (comparably) correct and consistent result of patient's test.
Relatively therefore the analysis result between instrument and/or laboratory can provide the measurement with the accordance of quality or performance standard, to help to guarantee and improve the quality of patient care.Before attempted in order to the variational technology between measurement and control instrument and/or laboratory, such as based on those of model as discussed above, but had limited or insignificant achievement.Analysis variability between instrument and laboratory is the result of the difference of the condition used when execution analysis.Traditionally, assess variability by the analysis of repeated sample, be called the QC(quality control) or control sample.The statistical study of result quantizes the variation in data set.The parameter of calculating in statistical study is used for the performance of more different instruments.The process of describing forms the basis by internal quality control (IQC) program of laboratory room managing.
The IQC process is useful when comparing the same analysis method, but does not provide whether good to being enough to report the indication of useful consequence clinically about performance.Evaluate (EQA) program by external mass and come the evaluation result accuracy, wherein, the end value of relatively being reported by different experiments chamber use same procedure.This program is labour intensive and time-consuming, and it increases along with the increase of instrument quantity.
Usually measure the IQC performance with the Westgard rule, the measurement of the quality control that its expression test result can be accepted or rejected.Usually realize Westgard rule or more rules, make such as the running counter to an of quality control rules, such as the control that makes more than two standard deviations drop on the mean value outside arrange measure send out other, the application of potential stricter quality control rules.Whether the quality control survey with producing for given test or instrument of rule can be accepted with definite test result.
Usually realize Westgard or more rules in the software package of the collection that promotes quality control data and figure demonstration.The software package of these types is used for arriving the application of particular analysis test to determine capability and performance with the concept of total error (TE) usually.Sometimes warn trend in analyzer operator numeric data with the Westgard rule, wherein, it is unpractical that figure shows.Usually, for example, Westgard rule is associated with automated procedures, and these automated procedures are used for based on accepting or refuse test result about the agreement of rule, and this agreement can be set up by professional consensus (professional consensus).
TE calculates the accurate and consistent result when usually guaranteeing to determine the quality control performance with the EQA data.The software package of realizing IQC is not provided for the link of EQA input usually, itself otherwise be based on manual input and provide.Therefore, the calculating that is used for the TE of each test on each analyzer of laboratory or the network significant difficulties that becomes.If do not realize in combination the EQA data with the software package that the IQC process is provided, the laboratory is usually with all tests on general Westgard rule application each analyzer in the laboratory, regardless of test performance.Yet the application of general Westard rule may not produce the abundant extra fine quality control performance standard for each test of carrying out on each analyzer.Therefore, in the situation that do not exist the EQA data can reduce significantly the benefit that the application by Westgard or more rules can obtain, the person causes the false rejection rate for the increase of IQC process, cost and the delay of the additional or increase when causing bearing results.
In addition, it is that Management And Administration (administrative) is intensive that current available software bag that be used for to carry out the IQC process trends towards, and is in essence therefore slightly to expend time in and expensive.Therefore, use and cost in order to reduce resource, the enforcement of IQC software package trends towards being confined to the minimum compound collection (least complex set) of Westgard rule, administers and maintains time and cost with minimizing.This puts into practice the fact and trends towards further emphasizing above-mentioned challenge.
The quality control performance that the EQA program representation is identified for analytical instrument and laboratory on the other hand.The EQA program requires for example ongoing test usually may how to depart from standard (norm) to set up instrument or laboratory usually.For example, the result of EQA program is commonly used to calculate the TE for given test, instrument or laboratory.The EQA test request is used for the operation of the fundamental analysis thing (analyte) in given test, instrument or laboratory and how compares with expected results with definite result.Can be based on the extensive testing result that is used for same analyte, perhaps develop expected results based on setting up standard based on the general protocol in science and analytical chemistry group for test result.Therefore, the estimation of EQA program supplying method deviation (bias), it can be used for determining whether test, instrument or laboratory are obtaining the result consistent with previous result or other instruments or laboratory.
The TE that the EQA procedure result usually is used for being identified for given test, instrument or laboratory in combination with the IQC process is with the accordance of the quality control standard determining and can develop by the agreement of scientist or AC.Therefore, as above-mentioned IQC Process Problems, the EQA procedure result may affect the oeverall quality performance for the pathology service.
The EQA program is in the face of with respect to a plurality of challenges of precision, that is should test, whether instrument or laboratory return to correct result.A difficulty for the EQA program is that different programs is used different statistical methods, and therefore not directly compares for the result that obtains.In addition, the EQA program in the lower operation of international quality assurance advisory group (NQAAP) is used in some laboratory of Britain, and it designs for the independent experiment chamber rather than as synthesizer.Some EQA program realized having improved along with analysis ability and quality and gradually the development quality control standard.Yet, along with quality standard narrows gradually or is being restricted aspect its standard, can represent that the peripheral result (outlying result) of valid data is judged as in narrower qualitative restrain outside.In addition, the specifications of quality that is used for the EQA program trends towards being subject to the impact of the performance change observed with the maximum group that represents single technology.
Due to respect to the realization of the instrument that is used for determining capability and performance and the above-mentioned challenge of validity, support that the direct comparability of patient data's transferability can data so do not exist.Usually, capability and performance measurement and instrument trend towards being not suitable for being widely used in the network of hospital, laboratory or instrument.
Summary of the invention
The disclosure provides the system and method for the capability and performance of the extensive group that analyzes and manage the entity of serving for the execution pathology.According to one side, the disclosure provides and has been used for the raw data that centralized collection obtains from independent test, medical instrument or analyzer, laboratory and/or hospital.According to statistical technique and performance standard, the raw data of centralized collection is formatd and handles to obtain the capability and performance data.Can share the capability and performance data across the medical science network, and can represent the capability and performance data with graphical format together with the guide of setting up that is used for capability and performance.Described system and method provide according to the precision of appointment and/or variance level consistent the capability and performance data.
According to one side of the present disclosure, come the centralized collection data according to fixed time or event constantly.Therefore it is current keeping the data of centralized collection, measures with the capability and performance that certain level is provided constantly.The process of collecting data can be full automatic, therefore reduces and formerly producing complicacy and the time that is associated that capability and performance is measured.
According on the other hand, for the transferability of improving, the raw data format of centralized collection is turned to XML.Can be in the medical science network or offer the data of XML form various to present the capability and performance data to multiple final user by in-house network or the Internet.
According on the other hand, system and method for the present disclosure provides chart to illustrate the capability and performance that is used for various medical instruments on a period of time.Can handle the various figure that provide to obtain to be used for the format of establishment figure or original data.Disclosed system and method can also be provided for the layering capability and performance figure of instrument quality performance, and it illustrates for example minimum/maximum, expectation and/or best in quality performance level.
According on the one hand, generate the QC result by each instrument in laboratory network.Instrument QC data are sent to linked server.This server sends data to central computer system based on scheduling.Central computer system is checked (collate) from the data of instrument with from the data of external mass assessment procedure.Process raw data with the generating structured data source, it is used as subsequently for the basis that generates the demonstration of summary data table and figure.
The remarkable span that disclosed system and method can be crossed over test, instrument, laboratory and/or hospital provides improvement and more unified capability and performance to measure to strengthen and allow patient data's transferability.In addition, disclosed system and method allows performance monitoring and the feedback of the improvement that is used for laboratory and hospital on the polymerization basis, and to improve consistance and capability and performance, it all trends towards improving patient care.
Description of drawings
With reference to accompanying drawing, be described in more detail below the disclosure, in described accompanying drawing:
Fig. 1 is the figure according to the quality control system of exemplary embodiment of the present disclosure;
Fig. 2 is the form that illustrates for the capability and performance value of listed analyte;
Fig. 3 is the demonstration according to the error reporting that is used for the capability and performance management of exemplary embodiment of the present disclosure;
Fig. 4 measures relevant qualitative data and the demonstration of calculating with determining capability and performance;
Fig. 5 is the Levey Jennings figure that the result of the analyte quality performance on a plurality of analyzers is shown;
Fig. 6 shows three layers of figure according to the accuracy comparison time of exemplary embodiment of the present disclosure; And
Fig. 7 is the process flow diagram that illustrates exemplary embodiment of the present disclosure.
Embodiment
The application requires Britain's provisional application of submitting on September 13rd, 2010 numbers 1015230.4, is entitled as the right of priority of A METHOD AND SYSTEM FOR MANAGING ANALYTICAL QUALITY IN NETWORKED LABORATORIES, and its full content is by incorporated herein by reference.
The disclosure derives measurement for capability and performance constantly based on the data based on experience or evidence of collecting from analytical instrument.These data are used for calculating about being used for the capability and performance measurement with reference to the given reference group at interval, and are how consistent with target or expected results to determine independent test, instrument, laboratory and/or medical service provider network.Realize that the CentraLink Data Management System that is provided by Siemens Company can be provided software of the present disclosure.
In the disclosure, the capability and performance intention allows to report useful clinically result to the physician.Analyze quality determine be based on to determine that the scientific research of " the biological variation " of individual and wider intragroup analyte carries out.A result of this research is the performance specification for " in vitro " diagnostic test, its describe in detail for analytical approach should obtain with the clinical state of correctly evaluating patient accurately and levels of precision.The back is and determines origin that capability and performance is relevant and the comment of practice.
Medical laboratory's test result is used to a plurality of purposes, comprises diagnosis, screening and monitors.Usually with the single-spot testing result with based on the reference interval of colony or usually based on Expert opinion the whole nation or local derivation value compare.The use of the medical laboratory's test result that is used to monitor is usually observed patient condition for experiencing the progress of medical condition along with patient.Patient monitoring so expression are for the conforming challenge of analysis of the series of tests that keeps carrying out on long-time section with a plurality of instruments of the network of using laboratory and/or hospital.The existence that precision between instrument or the analysis of deviation change trends towards affecting negatively the test practicality for diagnosis and supervision purpose.
The reference group is homogeneity preferably, and is used for the standard that references object (subject) comprises and is preferably limited by clear.Being used for 90% the preferred minimum number of putting the letter interval is at least 120 references object, and preferably recommends to carry out calculating according to international clinical chemistry alliance (IFCC).Preferably closely control with reference to the generation at interval and the analysis during using the period changes, because loose or uncontrolled analytic process can cause inconsistent with reference between interval and its colony that is applied to.
The reference interval of test is the biological (CV of variation in reference group's object
I) and object between the biological (CV that changes
G), before the analysis when setting up with reference to the interval (pre-analytical) and analyze variability (CV
A) product.Although usually reduce the trial with reference to error before the analysis during the foundation of interval, the interior biology of analysis deviation, method inexactness and object changes colony and method is specific contributes to some extent with reference to the interval.Therefore, the marked change of the analytical performance of method may have appreciable impact to the validity at the reference interval of deriving.
The tendency of changes of method deviation is in changing in each ratio with reference to the reference group outside restriction, this cause false just/increase of the ratio of the condition of forsaking one's love/reduce.The increase of method inexactness trends towards widening with reference to the interval and increases overlapping between ill and health population.The variation of method deviation and inexactness makes the ratio that drops on reference to the patient outside the interval significantly be changed on two parameters of impact indication change of the validity of shared term of reference.Yet keeping this deviation is CV
BRatio indication be protected with reference to the integrality at interval.These results trend towards being applicable to the non-Gaussian distribution of gaussian sum.
Therefore, in order to adopt and to keep the common reference interval, should monitor to derive analytical performance with reference to the method at interval by laboratory network.Monitor analytical performance by front taking the photograph ground (proactively), the analysis variation between the laboratory that same laboratory is interior or the same laboratory network is interior is minimized.
Because most of laboratory results are used to monitor rather than be used for diagnosis, so can have finite value as the instrument that is used for monitoring based on the reference value of colony.In fact, some test may be according to a sex index (CV
I/ CV
G) be affected.Have the test of high individual character, such as having low CV
I/ CV
GThe result of those tests of ratio (for example kreatinin test) can show marked change, but still is positioned at reference to the interval.On the contrary, have the test of low individual character, such as having high CV
I/ CV
GThose of ratio (for example iron test) can have the variation across whole test result with reference to the interval that there is no conspicuousness.
Sometimes recommend computing reference changing value (RCV) in order to monitor serial result about individuality.Formula in order to the RCV of a series of tests of calculate being used for carrying out on single instrument is
Wherein, CV
1The biological variation in indication is individual, CV
AInexactness is analyzed in indication, and Z is the constant relevant with probability.Under clinical labororatory's background, the value of Z is generally 1.96 for 95% probability.
Patient just means in the movement between network location measure patient's sample on a plurality of instrument.Each instrument has the degree of inexactness and deviation.Therefore, comprise as variance analysis deviation (Δ Β) afterwards, can following expression RCV value.
In above equation, Z and CV
IIt is constant.Therefore, the increase of analysis deviation and inexactness can be widened RCV and be reduced the very significant probability of variation of patient outcomes.In fact, RCV calculates in laboratory information system (LIS), perhaps provides in the user guided information list about the number percent of the conspicuousness of the serial results change of individuality.Therefore, the tendency of changes of the accuracy between the instrument in network and deviation is in making single RCV value invalid.
For the measurement of the improvement that obtains capability and performance, the disclosure provides and obtains relevant IQC and EQA data, and it can determine total error based on the reference interval of each test of each instrument of the given network that is used for medical service provider.Following with bulk analysis error (TE
A) be calculated as method deviation adding method inexactness Z doubly.
B
MThe deviation of expression and method mean value.In clinical labororatory, the value of usually selecting to be used for Z is used for 95% probability level of colony with expression, and it is arranged on Z 1.65 value usually.The total error that changes based on biology is to derive from three grades of models discussing in more detail below.Calculate total biological error according to following equation.
Wherein, respectively, for best, expectation and minimum/maximum horizontal, the value that is used for k be 0.25,0.5 and 0.75 and the value that is used for K' be 0.125,0.25 and 0.375.
Illustrate the typical change with reference to the interval in following table 1.
Table 1
The TE that table 1 illustrates be used to six the different immunoassays analyzers (Centaur XP) with the position that is distributed in three different locations measures.Each analyzer is equipped with calibration materials and the reagent that uses the same batch material.Measure 150 patient's sample on each analyzer.Set up for the result of each analyzer and pass through and Bablock(Passing and Bablock) the conversion equation.As shown in table 1, calculate the average percent total error for each analyzer.The size of total error number percent shows the marked change between different analyzers.This marked change causes from the widening of the reference interval of 10-25 pmol/L to 8-26 pmol/L, causes diagnosing new loss of energy.
If keep with reference to the interval, the number percent total error should be less than approximately 6.3%.Simultaneously, the method deviation should less than
And precision should less than
The predetermined best restriction of number percent total error that is used for having these analyzers of these tests is about 4.9%, and it is less than above-mentioned 6.3%, and previous " the best " restriction determined of this suggestion is suitable for protecting the transferability with reference to the interval.
Can define the quality monitoring program with the restriction accepted that concept utilization as discussed above is used for analytical performance.According to exemplary embodiment of the present disclosure, objectively Performance Characteristics is compared with the evaluating objects of weaving into well document.In addition, the specifications of quality of phase standard on the same group preferably is applicable to all analysis component of given network.A plurality of models of stablizing standard have been proposed to provide.Although the disclosure can be used any one in a plurality of models, following example is used based on the standards based on the biology variation in the meeting signature in Stockholm in 1999 by International Union of Pure and Applied Chemistry, the World Health Organisation and IFCC patronage.Should be clear that the disclosure is not limited to this model, and can use other models or model combination, have suitable result.One in the target of selected model is the global strategy that determines whether to set up for the laboratory quality.Meeting unanimously declares and has created the hierarchy that is used for five available quality normative models: clinical requirement; Standard based on the biology variation; Standard based on the specialty recommendation; EQAS organizer's the specifications of quality; And about the publish data of prior art.
There is challenge during some in realizing these models, for example may do not exist for the strategy of determining capability and performance.Yet, being used for can be used for the clinical requirement model such as the strategy of the minority diagnostic test of PSA, cholesterol and TSH, it can be incorporated in disclosure system and method.In addition, if being designed to have, developed based on more strategies of clinical requirement the dirigibility of upgrading by software.
Next model in hierarchy is based on the biological specifications of quality that changes.The chances are for this model by most widely accepted candidate.Can there be some models in biological variation model.The maximally related analytical performance that makes is relevant to impact on term of reference.Some researcher developed the formula that is used for keeping in time can accepting with the transferability required maximum at the reference interval of geography inexactness and deviation, as mentioned concise and to the point the discussion.Yet the specifications of quality of from then on model derivation too strictly and not allows widespread use.Yet, can use biological variation model as instructing and calculate admissible maximum deviation and precision to protect the validity of sharing with reference to the interval.
Three grades of models are by considering and can allowing more dirigibility by the thing that current techniques realizes.This model is exercisable, and can be provided for the stabilised quality standard of network.A major advantage that is used for biological variation model is that the biological database that changes can be used for a large amount of tests.Almost 316 tests are carefully examined and check by various researchers.In capability and performance was applied to the network of medical service provider, this model can have large-scale application.These three grades of models use at the quality plan that is used for the internal quality control program.It is used for deriving the restriction accepted that is used for performance in EQA in the disclosure.It can also be used to be provided for the restriction of gratifying analytical performance when New Evaluation Method or instrument.This model also has the potentiality that are used to new equipment bid (tender).
Three grades of models have key character with respect to every other biological variation model, because it allow to form allows can to accept quality objective in time and becomes stricter yardstick with the improvement of technology.Test needs not be permanent to the distribution of model level, and preferably is regarded as changing to allow to be distributed in to have in the improved situation of analytical performance dynamically.When test has realized stable performance level, can use the upgrading for standard.This system can change to change in disease for the shortage of the availability of some analyte and the biology that is used for some analyte with biology and is restricted relatively than observation higher in health.Yet, at present, selected the biology in health to change, because it will cause stricter evaluating objects.The biological variation of Sexual-related is not useable for some hormone, for example lactogen and progesterone.In fact, certain tittle does not show biological variability, for example medicine.For these analytes, derived in order to calculate the formula for the expectation evaluating objects of precision based on basic pharmacokinetics theory.Use same principle, this formula can be used for calculating the evaluating objects (following discussion) for any medicine.
Control restriction according to IQC of the present disclosure and be based on biological variation model.Also specified the similar standardization practice that has for the similar restriction of each analyzer of network.In addition, system and method for the present disclosure is by in the situation that the IQC measurement result surpasses 2SD reruns patient's sample and effectively introduced the real time monitoring that is used for the method precision.
Can be used for the Westgard rule induction with analyzing the TE value.The software of realizing open system and method can calculate and the analysis and assessment total error, and it provides some advantages.At first, the availability of total error data can allow the derivation of the specific Westgard rule of analyte, wherein, analyze TE in consistent mode greater than the TE that derives on biology.The second, this software can help to identify TE which component, be that deviation and inexactness should be noted that.For example, for those chemical examinations with inherent variability, acceptable energy can be realized by improving analysis precision in the laboratory.
The model description that changes based on biology three acceptable levels of performance, best, expectation and minimum/maximum.Each level allows the various combination of inexactness and deviation, and allows the different fixed percentage of colony to drop on outside reference for variance level limit.It is available being used for the data that the biology of nearly all analyte of main flow biological chemistry changes, and can be used for calculating the specifications of quality for inexactness deviation and total error.
Most of clinical labororatories use IQC has had reagent kit (kit) manufacturer to provide or purely based on analytical performance and the control that distributes in this locality restriction.This method has following shortcoming, and namely it is based on the intrinsic inexactness of method, and will therefore have low error detection rate.In order to improve the precision of the method, the exemplary embodiment of disclosed system and method is used the network of three teaching hospitals and the related district general hospitals of serving 1,300,000 populations.The core laboratory has identical hardware and assay method.This network is used for based on developing and safeguard the IQC restriction according to the biological standard that changes of the present disclosure.This process provides some ingredients, comprises the analysis CV that obtains
AWith admissible CV
BComparison.In addition, calculate biological CV according to three grades of models that comprise the best, expectation and minimum/maximum horizontal.Then come comparison CV across these three grades of models
ATo determine capability and performance.
Be used for each separately the level of the standard of test be based on analysis ability and how use this test and definite at clinical settings.The display analysis platform can satisfy the evaluating objects for most of analytes as a result.Fig. 2 has described the performance of 32 analytes examining for the exploitation of capability and performance standard in detail.Monitor the inexactness of 25 general chemistry and 17 immunoassays analytes by commercial quality control (QC) material of analyzing two levels every day within 3 months periods.Change for the inexactness of assessing from the target inexactness of objective standard derivation for 32 analytes based on biology.Be used for each analyte the QC data point quantity for scope for general chemical analyte from 600 to 1200 and for the immunoassays analyte scope from 90 to 140.Entry in Fig. 2 illustrates low IQC data, and it is more relevant potentially, because usually more be difficult to realize better performance under low IQC level.The entry that presents with runic represents the current performance level, and the entry with asterisk represents temporarily controlling outside chemical examination.
Generally, for 32/42 analyte, satisfy the objective quality standard.These data show for most of general chemical analytes, can obtain the specifications of quality that changes based on biology by current techniques.For having narrow CV
IAnalyte, for example sodium, calcium and chloride, minimum performance is exactly target.Evaluate for the analyte that does not satisfy biological variation standard or be used for the performance of the disabled analyte of biological delta data for quality objective based on the alternate model of for example EQA standard.
The very significant probability of deviation around measuring that is in three performance levels at 95% interval based on research is selected the target for each analyte.With respect to medicine, the below is the formula for the computational analysis target.
Wherein, T is the time interval between dosage, and T is the half life period of medicine.The deviation of value 95% is contained in following calculating.
The clinical preference for test is also considered in the derivation of evaluating objects.As previously mentioned, biological variation model has been described the admissibility energy of three levels.When the method can realize three whole levels, selected level was preferably based on the recommendation of use test in clinical settings.For example, can provide the recommendation of indication than the use of low target, such as in some test, for example cholesterol, may be correlated with.This evaluating objects is used to wherein using CV in IQC Performance Evaluation process per month
BPrecision as desired value.This evaluating objects is by being used to deviation data (to our method mean value B for the deviate that has derived for three grades of models to the assessment of each analyte of obtaining from EQA
MDeviation) use.In addition, use per month CV
AAnd B
MCalculate bulk analysis error (TE for each analyte
A).Then can assess TE for the total error that derives from biology variation standard
A
According to exemplary embodiment, collect IQC and EQA data from all places of medical science service network.This system is allowed for the application of the same analysis target in all laboratories in network, and provides statistical tool to analyze described analysis data, no matter when carries out test in network.
Fig. 1 illustrates for the framework 100 of realizing open system and method.Central site network 110 comprises that database 112 is to keep all quality index (IQC and EQA).The capacity of database 112 is enough to for example 10 annual datas of storage.The central site network 110 that can be implemented as single computing equipment is held the software that analyzer 120-123 from each core Biochemistry Experiment chamber 130-133 catches the IQC data regularly.Then these data are automatically imported in the addressable file of infosystem 140 of pathology network.According to exemplary embodiment, file is formatted as the XML file so that structured data source to be provided.Software can present data from file with graphical format 144 and table format 142,146,148.IQC form 142 can provide the accumulative total summary calculated for the monthly average of each test/analyzer 120-123 of core Biochemistry Experiment chamber 130-133, SD, at the quantity of the outlier (outlier) of 4 SD outsides and reagent lot number (its can manually be inputted or automatically record).For example, this software also provides the access to the IQC raw data of the tabulation in spreadsheet.This raw data can be used for further statistical study to help maintenance (troubleshooting) bad performance.Navigational tool provides being stored in the resultful easy access of institute in database 112 and allowing to monitor in time performance.The QC data can or be controlled lot number and retrieve by independent instrument, date.
Fig. 1 also illustrates the electronics of EQA data 150 or input automatically.The EQA routine data provides collaboratively with a plurality of sources, such as, UK NEQAS Scheme Organisers for example.The collection of EQA data can be completed in the electronics mode, preferably completing with the prearrange form of central database 112 compatibilities.But software comes the comparative approach deviation for the permissible variation of deriving from three grades of models, for example calculates to the deviation of method mean value.Software for according to the modification of the present disclosure EQA specifications of quality and for all the EQA performance index for all laboratories in network of being compared to each other to generate summary report.Can revise current EQA for the EQA performance index limit to use method group scope as the acceptability of EQA aspect can upper and lower bound.This process provides relatively narrow restriction to obtain the early detection of bad performance with help.
With reference now to Fig. 3,, representative table shows that 300 provide the capability and performance data that generate per month.Show that 300 provide the list of the test of the permission restriction that surpasses the distribution that is used for TE.Demonstration 300 comprises can activated to provide respectively the button 310,312 that the tables of data of expression shows or figure shows in Figure 4 and 5-6 respectively.Like this, the user can be rapidly and is easily obtained the correlated quality performance data, also has simultaneously the option of data that audit was used for capability and performance is measured and was used for the graph data formulism of capability and performance.
With reference now to Fig. 4,, list data shows that 400 illustrate from the data of network analyser derivation and the calculated value that is used for the capability and performance measurement.For example, demonstration 400 is listed and can be selected to examine by the user a plurality of different tests 402 of the data relevant from given test.Show that 400 can provide the raw data 404 of collecting with the spreadsheet form further to examine for the user.Can also be provided for from standard deviation and the CV% of mean value derivation and the calculated value of CV-B%, it is the biology variation (CV%) from the performance specification data.Show that 400 also provide Bias%, it is to be used for the mean value of EQA data and the percent difference between method mean value.Bias-B% also is provided, and it is the allowed Bias% from the performance specification data.
Also show from the calculating total error number percent TE% of CV%t and Bias% derivation.Also total error deviation percent TE-B% is provided as the allowed total error number percent from the performance specification data.Show 400 therefore provide be used for particular instrument on the experience of fc-specific test FC or the relevant bulk information of proof result, can be based on a plurality of standards with its grouping or polymerization, such as to different instruments, instrument, laboratory network, date or the general test of other packet layout as group.
With reference now to Fig. 5,, Levey-Jennings Figure 50 0 shows the capability and performance data for kit 510-517.Levey-Jennings figure is that the quality control figure with the deviation of mean value represents, and usually show the typical standard deviation with the designation data deviation average what.Show 500 examples that show by the Levey-Jennings chart of Software Create of the present disclosure.Show that 500 typical case is the glucose mean value of measuring within the period of six months on eight analyzers 510-517.The IQC target average is that 3.5 mmol/L and evaluating objects are confirmed as aspiration level.The biological CV that is used for glucose under aspiration level is 2.9%.Be identified for showing 500 standard deviation with equation SD=(mean value * CV%)/100.Each some expression on the figure of demonstration 500 is the mean value of 200-400 per month.The shadow region represents 1SD, 2SD and 3SD.For the purpose of glucose test, use 1
2SDSingle Westgard rule.If standard deviation greater than 2SD, is not reported for the patient data who shows 500.
With reference now to Fig. 6,, show chart and show that 600 conducts are by the example of the precision chart of Software Create of the present disclosure.This example shows the glucose precision in the certain hour interval.Different shadow regions represents to measure for the best (bottom) of glucose test, expectation (centre) and minimum/maximum () capability and performance.Show that 600 benefit is can be easily and notice rapidly the instrument with bad performance, this can cause the correction measure realized fast.Show that 600 show the monthly average value of each test/analyzer 510-517 to provide the accumulative total monthly average value in time window.This software can be relatively for the IQC performance of each test on all places and with this and from allowing CV for admissibility
BThe SD restriction of deriving presents together.These figure make at a glance can relatively be used for the IQC performance of the each test on all places.
The exemplary embodiment that can following description be used for the standard of three grades of models.Optimum performance: analyze inexactness＜0.25 CV
1And deviation
Expected performance: analyze inexactness＜0.5 CV
1And deviation
Minimum/maximum performance: analyze inexactness＜0.75 CV
1And deviation
Derive the total error that changes based on biology from three grades of models.With analytical error (TE
A) be calculated as deviation adding method inexactness Z doubly.The formula of describing this equation is
In clinical labororatory, usually select the Z multiplier under 95% probability level, be 1.65.The calculating that is used for the biology total error is
, wherein, for the best, expectation and minimum/maximum horizontal, respectively, the k value is 0.25,0.5 and 0.75, and the k' value is 0.125,0.25 and 0.375.
With reference now to Fig. 7,, illustrate the process flow diagram 700 of exemplary embodiment of the present disclosure.Embodiment shown in Fig. 7 is the process for the capability and performance of supervision and ADM service network, and from the collection of IQC and EQA data, as shown in frame 710.Usually the instrument from the medical science service network is collected the IQC data constantly, such as the activation by can be take time or event-driven as basic execution script.This script can be so that the data that are stored in various instruments be retrieved and be forwarded to central computer in order to collect and process.In case collected data, central computer for example can be from this data generating structured data source, to improve format and the transferability of information, as shown in frame 712.As example, can data structured be presented the transfer of mechanism with permission data or data representation to HTML end points or other structural datas with the XML form.
In case data are placed in structured format, can carry out about the calculating of data and measure to produce capability and performance, as shown in frame 714.For example, can calculate total error TE for given test, instrument, laboratory or medical service network with IQC and EQA data.Can be based on carrying out this type of calculating to testing significant relevant with colony reference interval.This calculating can be used for being identified for the parameter that capability and performance is measured, such as being provided by the Westgard rule.In case carried out the calculating of expectation, can present data and the original or structural data that obtains to the final user with specific format, as shown in frame 716.Present form and can comprise list data for given test, instrument, laboratory or network, and can time-based interval, mean value or measurement that may significant other types for capability and performance with its polymerization.
Be used for realizing that the software of open system and method can be used for generating per month report.The example of this type of report comprises:
1. fail to observe the summary of the test that can allow the total error standard.This report is to provide on the upper strata of the presentation information relevant with capability and performance.Double-click on failure testing can allow the access of two hyperlink that are used for IQC data and EQA data is identified the source of error with help.
2. only fail to observe the summary in the test of the network quality standard of IQC level.
When with its with according to the summary that makes the test of EQA procedure failure when the network-external specifications of quality is compared of having revised of the present disclosure.
4. when being compared with the current standard of EQA, it makes the summary of the test of EQA scheme failure.
Provide following example to illustrate determining of capability and performance measurement.
Example 1
The inexactness that is in three levels under low QC level (110 mmol/L) on the impact of serum sodium.
Along with sodium is reported as integer, effectively the deviation (dispersion) of whole above three given 4 mmol of level are changed (108-112).Therefore, at the minimum level select target.The current data field represents across the variation in 3 months periods of 9 independent analyzers.
Example 2
The inexactness that is in three levels under 7 mmol/L on the impact of glucose mean value.
Glucose is reported as a radix point by gamut, and is diagnostically used under the concentration of 7 mmol/L.Current performance is positioned at aspiration level, yet optimum level is the dreamboat that will realize for making clinical decision.
The disclosure provides a plurality of advantages, comprises the ability of the quantity that reduces the EQA report, is reduced to two per month from 400 reports of remaining sum per month that are used for all places.Can also check and present IQC data from all places in a report, this allows to monitor and the possibility of the remarkable efficient of management quality aspect of performance.The acquiescence page (referring to Fig. 3) of tables of data is surpassed the test list of the permission restriction that is used for total error and can generate for the tables of data of indicated test or the hyperlink button of figure demonstration.These features of the present disclosure can reduce the time quantum that the auditor spends at the confirmation analysis aspect of performance significantly.The open system and method for realizing with software is addressable on all places, and makes the lab assistant from the three unities to compare performance with other places.Can generate in real time report, this has reduced the requirement to the data library storage, in case and the permission latest data can be with just with its combination.In addition, in case set up, present disclosed system and method can automatically and in the situation that not have uncommon maintenance or intervention to move.
Pathology enter new era, and general in the face of affecting a plurality of challenges of the mode of sending the pathology service.Medical practice more and more becomes more based on evidence, and is setting up the ever-increasing clinical strategy of quantity to be used for diagnostic monitoring and screening.Plotting method is becoming more important with the specifications of quality that definition is used for the required analysis of these clinical development of support.Come the up-to-date report imagination of auto-correlation publication in pathological future, can come delivery service with a small amount of separate network.The disclosure has satisfied the needs that are used for the capability and performance of this environment, combines simultaneously the dirigibility of the solution that is allowed for following pathology service configuration.
Operation described herein is exemplary purely and does not hint particular order.In addition, in due course, can use operation with any sequence, and can partly use operation.In view of above embodiment, be understood that disclosed system, equipment, method and/or purposes can adopt the various computer implemented operation that relates to the data of transmitting or storing in computer system.These operations are those of physical manipulation of requirement physical quantity.Usually, although not necessarily, this tittle takes to be stored, transmits, makes up, relatively and otherwise the form of electricity, magnetic or the light signal handled.
The described herein any operation that forms a part of this disclosure is useful machine operation.The disclosure also relates to for equipment or the device of carrying out these operations.Can construct particularly this device for the purpose that requires, perhaps this device can be the multi-purpose computer that is optionally activated or configured by the computer program that is stored in computing machine.Especially, the various general-purpose machinerys that following employing can be coupled to one or more processors of one or more computer-readable mediums use together with the computer program of writing according to herein instruction, and perhaps the more special device of structure may be more easily with the operation of execution requirements.
Disclosed system and method can also be presented as the computer-readable code on computer-readable medium.Computer-readable medium is any data storage device that can store data, and it can be read by computing machine subsequently.The example of computer-readable medium comprises hard disk drive, ROM (read-only memory), random access storage device, CD-ROM, CD-R, CD-RW, tape and other optics and non-optical data storage device.Computer-readable medium can also be distributed on the computer system of network coupling, make computer-readable code be stored and carry out with distributed way.
Aforementioned description is for specific embodiment of the present disclosure.Yet, will be clear that and can carry out various changes and modification to described embodiment, obtain their some or all advantage.Can realize program described herein, process and/or module with hardware, software, be presented as have programmed instruction, the computer-readable medium of firmware or its combination.For example, can carry out function described herein by the processor of carrying out the programmed instruction outside storer or other memory devices.Therefore, the purpose of appended claims is all this type of change and modifications that cover in true spirit of the present disclosure and scope.
Claims (22)
1. the system of the analysis quality of a network that is used for the administrative analysis instrument comprises:
In network and be coupled to the central computer of analytical instrument by network, this central computer comprises processor and can operate storer for the storage of processor executable instruction, this processor can operate for from memory search and carry out instruction with:
From analytical instrument receiving and analyzing quality relevant information;
With the information format that receives to produce structural data; And
At least one statistics conversion relevant with mass measurement is applied to formatted data analyzes qualitative data to produce.
2. system according to claim 1, wherein, described processor also can operate for based on scheduling reception information.
3. system according to claim 1, wherein, described structural data is the XML form.
4. system according to claim 1, wherein, add up conversion relevant to biological delta data.
5. system according to claim 1, wherein, add up conversion relevant to internal quality control (IQC) process.
6. system according to claim 1, wherein, add up conversion relevant to external mass evaluation (EQA) program.
7. system according to claim 1, wherein, add up conversion relevant to definite total error (TE).
8. system according to claim 1, wherein, described processor also can operate for generating the figure demonstration relevant with analyzing qualitative data.
9. system according to claim 8, wherein, described figure shows provides the visual arrangement relevant to analyzing qualitative data.
10. system according to claim 9, wherein, described visual arrangement is based on three layers of demonstration of indicating instrument performance.
11. system according to claim 10, wherein, the link that can operate for the figure demonstration of reference information for providing also can be provided described processor.
12. the method for the analysis quality of the network of administrative analysis instrument comprises:
From analytical instrument receiving and analyzing quality relevant information;
With the information format that receives to produce structural data; And
At least one statistics conversion relevant with mass measurement is applied to formatted data analyzes qualitative data to produce.
13. method according to claim 12 also comprises based on scheduling reception information.
14. method according to claim 12, wherein, described structural data is the XML form.
15. method according to claim 12, wherein, the statistics conversion is relevant to biological delta data.
16. method according to claim 12, wherein, the statistics conversion is relevant to the IQC process.
17. method according to claim 12, wherein, the statistics conversion is relevant to the EQA program.
18. method according to claim 12 comprises that also generating the figure relevant to analyzing qualitative data shows.
19. method according to claim 18 also comprises the visual arrangement that provides relevant to analyzing qualitative data.
20. method according to claim 19 wherein, provides visual arrangement according to three layers of demonstration of indicating instrument performance.
21. the method for the analysis quality of the network of administrative analysis instrument comprises:
Collection of biological changes with reference to interval data, IQC data and EQA data;
Change according to biology and calculate TE with reference to interval data, IQC data and EQA data; And
With the TE that calculates with predetermined can accept to limit compare.
22. method according to claim 21 also comprises according to following equation and calculates TE:
Wherein, B
MExpression is for the deviation of method mean value, and Z represents to comprise relevant value to colony, and CV represents biological the variation.
Applications Claiming Priority (3)
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| GB1015230.4 | 2010-09-13 | ||
| GBGB1015230.4A GB201015230D0 (en) | 2010-09-13 | 2010-09-13 | A method and system for managing analytical quality in networked laboratories |
| PCT/US2011/051331 WO2012037079A1 (en) | 2010-09-13 | 2011-09-13 | A method and system for managing analytical quality in networked laboratories |
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| CN103097864A true CN103097864A (en) | 2013-05-08 |
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| JP (1) | JP2013538408A (en) |
| CN (1) | CN103097864A (en) |
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| WO (1) | WO2012037079A1 (en) |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN117434289A (en) * | 2023-12-20 | 2024-01-23 | 北京众驰伟业科技发展有限公司 | Quality control system of full-automatic coagulation tester |
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| US10089443B2 (en) | 2012-05-15 | 2018-10-02 | Baxter International Inc. | Home medical device systems and methods for therapy prescription and tracking, servicing and inventory |
| JP2015194903A (en) * | 2014-03-31 | 2015-11-05 | 栄研化学株式会社 | External accuracy management system |
| CN104714429A (en) * | 2015-03-10 | 2015-06-17 | 华北电力科学研究院有限责任公司 | Coal sample experiment data acquisition and analysis system and method |
| CN107667405B (en) * | 2015-06-05 | 2022-02-18 | 雅培医护站股份有限公司 | System and method for ensuring quality compliance of point-of-care instruments used with single-use testing devices |
| EP3422014A1 (en) * | 2017-06-27 | 2019-01-02 | F. Hoffmann-La Roche AG | Laboratory system |
| CN113219182B (en) * | 2021-06-03 | 2022-10-14 | 首都医科大学附属北京朝阳医院 | Method for analyzing TSH multi-system comparability by using quality evaluation data in rooms |
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- 2010-09-13 GB GBGB1015230.4A patent/GB201015230D0/en not_active Ceased
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- 2011-09-13 JP JP2013529257A patent/JP2013538408A/en not_active Withdrawn
- 2011-09-13 WO PCT/US2011/051331 patent/WO2012037079A1/en active Application Filing
- 2011-09-13 EP EP11825766.6A patent/EP2603777A1/en not_active Withdrawn
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| US20030101012A1 (en) * | 2001-08-24 | 2003-05-29 | Bio-Rad Laboratories, Inc. | Biometric quality control process |
| US20030110010A1 (en) * | 2001-09-10 | 2003-06-12 | Jeol Ltd. | Method and system for managing data |
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| CN117434289A (en) * | 2023-12-20 | 2024-01-23 | 北京众驰伟业科技发展有限公司 | Quality control system of full-automatic coagulation tester |
| CN117434289B (en) * | 2023-12-20 | 2024-02-27 | 北京众驰伟业科技发展有限公司 | Quality control system of full-automatic coagulation tester |
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| EP2603777A1 (en) | 2013-06-19 |
| WO2012037079A1 (en) | 2012-03-22 |
| GB201015230D0 (en) | 2010-10-27 |
| JP2013538408A (en) | 2013-10-10 |
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