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MultiQC - User manual

1. 90 ae es 2 80 4 70 6 E e E Arsenazo mg L Mean mg L The conclusion 1s that the scatter plot and the difference plot are complementary The former evaluates the average agreement between all of the pairs whilst the latter individually focuses on each pair The scatter plot is a tool to search for differences of calibration The difference plot is a tool to search for aberrant pairs 16 7 Remarks gt A prerequisite to the difference plot The difference plot implemented in MultiQC compares deviations between analytical methods to medical tolerance taken as criterion of judgement This comparison is senseless if each method does not individually meet the criterion So a prerequisite before any method comparison through a scatter plot is to check that the capability index of each method under evaluation is greater than 1 gt The Bland Altman plot Bland and Altman published a paper in The Lancet 1986 which popularized the difference plot among clinical researchers MultiQC does not implement the difference plot exactly as it was described by Bland and Altman because it is not well adapted to clinical chemistry data e The reportable range of analytical methods is much wider than the range of clinical measurements Range ratios in routine clinical chemistry generally exceed 10 So the hypothesis of homoscedasticity is far from being fulfilled A log transformation would be always necessary mak
2. The tolerance strip and the frame Calibration interval are simultaneously updated gt Multi point calibration Let us now assume that the instrument was calibrated in 6 points This would mean as above that the actual response curve 1s true for these six concentrations Practically because of the calibration uncertainty these six points are never perfectly aligned In this case you must check the box Multi point calibration and drop two calibration marks on the curve at the two ends of the calibration interval Then MultiQC calculates the ideal response line as the regression line of all the points of the response curve between the two calibration marks 6l The response curve 1s drawn blue between the two calibration marks to remind that the position of the ideal response line is based on the whole interval and not only on its two ends Multi point calibration Ends of the calibration interval Reportable range h gt Linear response curve a is o AS Assigned mg L QO 20 z If the best response curve estimated by MultiQC is a straight line there is no need to enter calibrations marks The reportable range equals the tested range 15 5 Storing reportable range verifications When the plot is OK you must save it with the button Save It is then stored in f Remark F4 the history of reportable range verifications and will be easy to reach a E Thanks to a linearity icon visible in th
3. 64 Saline or even water can be taken as low pool with a nil concentration in many cases The objection of matrix effect seems to be largely overemphasized A high pool should be easily found among the highest daily samples of the laboratory that need to be re processed after having been diluted Considering the accuracy of in house sequential mixing by trained operators purchasing commercial linearity verifiers often appears as a waste of money which is not balanced by more reliable samples 65 16 Method comparison Method comparison is performed in clinical chemistry laboratories to evaluate the agreement between two analytical methods Data are obtained collecting samples uniformly distributed in the reportable range They are split in half and one piece is assayed by each method MultiQC includes a module to calculate plot and archive comparison data An e learning how to tutorial for the method validation module of MultiQC is in preparation It will be available at www multiqc com 16 1 When to compare Method comparison is performed whenever a new method is considered for replacing a current one Interchanging methods may be e Definitive if the new method has better operational qualities than the former one e Temporary if the new method is only an alternative method which can replace the current one in case of failure of the routine analyzer e Cyclic when two analyzers are performing the same assays at different hou
4. Archived GC E 2700 Serum Acide unique ALF Amylase Bicarbonate Bili dir Bili tot Calcium Chlorure Chol H L Chol LOL Cholest rol CK LAP Lr atinine Fer GGT Glucose a004 2006 10 26 03 2007 GOT AST GPTALT M 44 oc Rep Sq Multivariate known params TPHOCVOHAIEL a amp l Main menu 2 Identification of operators 3 Choose between current and archived QC data 4 Two level tree view to select the working analyte Analytes second level are grouped in sections first level The tree view can be aligned on the right or on the left hand of the charts see section 13 2 5 A splitter between the tree view and the charts changes the width of the panels 6 Flashing pane to remind that QC data are waiting for validation in the pending queue 7 Flashing pane to remind that repeatability data have been received from a connected analyzer 8 Flashing icon to remind that the time interval between backups elapsed 10 Current reagent lot 4641 Multiqual 1 axe t 7 30 CV 1 52 Multiqual 2 46512 tgt 19 00 ESI a 2 Multiqual 3 a 46313 tgt 63 00 CV 4 SHEE HH HH HHH H HH HHH HH H H HH H H Hotelling s T My F fo CO Te wo amp Ss A DD iy Py Oy Oy Py EN m me a E a a a E te SSS ADDA FH Ca aa E E a a a a Visible QC points Public ii Private EGA on o Chart 1 m va 1 00 viS 2 Every chart Nearest leve Expand Y cale Program registe
5. It also depends on the number of degrees of freedom of the estimate s MultiQC has a built in Student s table Instances of control intervals for variable reference pools are shown in the table on the right ARL 370 Size of reference pool Control interval CO gt Where can find explanations on the statistical methods implemented in MultiQC Basic documents on up to date methods of quality control do not exist in the clinical laboratory literature It 1s necessary to turn to the engineering world to find valuable information e The e Handbook of Statistical Methods by the National Institute of Standards and Technology is freely available on the web http www itl nist gov div898 handbook e Introduction to Statistical Quality Control a book written by Douglas C Montgomery John Wiley and Sons Inc 5th edition 2004 e Statistical Methods for Quality Improvement a book written by Thomas P Ryan John Wiley and Sons Inc 2 edition 2000 e Statistical Process Adjustment for Quality Control a book written by Enrique del Castillo John Wiley and Sons Inc 2002 75 gt How many decimal places are necessary for QC It is generally essential to output QC results from the analyzer with an additional decimal place in comparison to results from patients Rounding data prevents from a valid estimate of SD Statistical control is wrong when the Shewhart s chart is made of a series of points oscillati
6. a kd oe FO a De rt l Select the analyte with a left click of the mouse on the analytes tree view 2 Click on the main menu Data Entry gt QC vector to open the entry dialog shortcut F1 3 Or more quickly you can double click on the name of the analyte in the tree view 4 In the entry dialog fill in the fields date time concentrations and comment Use the arrow up and down keys or the shift Tab key to navigate between the entry fields Forty characters are allowed for comments 5 Click on the button Rate to switch to the validation dialog 6 Refer to section 10 5 for the use of the box Initialize EWMA 7 To quit press the button Cancel or the key Escape While entering data the background charts remain active The analyte can be changed in the tree view the charts can be scrolled and the hints can be opened hovering above the points with the mouse 14 3 3 Entering and rating an EQA return Go to the menu Data entry gt EQA result While entering EQA data in the entry dialog the background charts remain active The analytes can be changed the charts can be scrolled and the hints can be opened hovering above the points with the mouse l Fill in the fields EQA ID Date Time Lab value Peer group Use the Arrow keys or the Tab key to navigate between the entry fields dau Enter EQA result x l l serum I riglyceride 2 Click on the button Rate to display the EQA rating EWA ID RIDAS 2872 12 Ope
7. gt Control parameters gt Known params gt Apply Thus the means and SDs are frozen and no longer dependent on a reference pool that will disappear with archiving 3 You can now archive the analyte Menu Maintenance gt Analyte gt Archive The charts will be blanked but the QC parameters will be kept unchanged 4 Your QC is now ready to go on again with blank charts keeping the same means and SDs as before You have only to update the mean of the changed material that you can retrieve from the relevant chart of the cloned analyte Generally the SD does not need to be updated 5 You must also update the number of the batch of the new lot of control material refer to section 14 1 6 Finally you have to erase the cloned analyte Important Do not forget to backup before performing the changes above to be able to restore to the initial status in case of error gt Control limits of the EWMV MutiQC makes use of control limits for EWMV that have been empirically calculated through computer simulations For each smoothing factor available in the program a non linear regression formula has been established For instance the formula for lambda 0 10 is Control limit of 0 8941 0 0987 In ARL 0 0027 In ARL This function works for any ARL between 10 and 10000 and a one sided rejection region 76 gt The Hotelling s T is out of control but not the individual control charts or vice versa Refer to th
8. will be used to format QC data before displaying or printing An additional decimal place will be used for the means Note that computing and saving to files is made in full precision real numbers Rounding displayed data does not lead to any loss of precision 4 Select a pre defined unit name or type in a new one if necessary 5 Choose a number of QC levels from 1 to 6 6 Most often you will keep the default smoothing factors needed to calculate the EWMA and EWMV 7 MultiQC can monitor your analytical process with any of four control methods e Statistical univariate control traditional QC with independent charts e Statistical multivariate control e Long term acceptance short term control LTA STC e Non statistical quality control with arbitrary limits and targets 8 This group box of fields depends on the control method you have selected Refer to the explanations in section 7 1 to 7 4 9 Click on the button Create to validate the entries The background charts window is immediately updated 10 QC data of each analyte are stored in an individual file with a random name and the extension lt qcf gt The path to this file is shown in the bottom status bar 11 To leave the dialog without taking into account the modified fields use the button Exit the key Escape or the close box of the window 7 2 Univariate and Multivariate Statistical QC In statistical QC limits are derived from the natural variation of the a
9. 11 with the mouse cursor to read the comment 8 Rejected point pink and not linked to other points This point is stored but not included in the Statistics 9 Identification of the current control material with the relevant statistics A more detailed table of control limits is available through the menu Current analyte gt Limits The background colour is a reminder of the current control mode see colour codes in section 11 1 10 The background colours of the charts may be scaled as in the picture above or restricted to three colours In the latter case the limits between the green and the 173 yellow areas are target 2 3 control interval Thus if the control interval limit yellow red is 3 SD the limit green yellow is 2 SD 16 l Every operator can only customize the style of its own charts see section 13 2 1 74 eel eens or the style of the anonymous operator Noname 172 DRL Background colours are never scaled in the LTA STC charts There is a special 170 set of background colours independent from the background colours of other QC modes 2 3 Clicking on the charts Click of the mouse Left click Opens the relevant table and Pops up a menu to edit or selects the row of the clicked delete the clicked item if you item are a supervisor a Hand cursor to scroll the Pops up the menu Current Outside a graphical item charts analyte 2 4 EQA target flags Results of EQA assays cannot be d
10. Across analytes Additional submenus Across analytes show and print summary reports for all of the analytes in a section e Control limits e Parameters of analytes e Tolerances e Control materials e Reagent lots 38 10 Special management of data 10 1 Editing or deleting a QC vector It is possible to edit or erase a mis entered QC vector after its validation Changing a validated QC vector requires the access rights of a supervisor Important Validation is always connected with the present reference pool of QC vectors When re validating a passed QC vector the Hotelling s T and the relevant control status may change if the reference pool has changed even if the QC data are not modified Two ways are provided to trigger the edition of a QC vector gt Editing from the charts Right click on a QC point in any Shewhart s chart or T chart to pop up a local menu Edit comment allows a change limited to the comment The QC vector 1s not re validated Edit comment Edit OC vector Initialize EWMA Erase OC vector Edit QC vector removes the clicked vector from the sequence of QC points in the charts and displays it in the QC entry dialog where you can edit it and re validate ao Erase QC vector erases the clicked column of QC points gt Editing from the table of QC vectors Open this table as shown 1n section 8 2 eG Sree Oe OL att CO Olympus Table of OC vectors Aala several QC Style Export Edit P
11. Changing the section of an analyte in the tree view It is very easy to re organize the analytes in the tree view of MultiQC e Open the dialog Configuration of analytes e Enter anew section name e Validate with the button Update analyte If the new section name already exists in the tree view the analyte will be moved to this section If the new section 1s unknown it will be created 31 8 Tables within analytes 8 1 Three tables of data for each analyte MultiQC can display the raw data in three tables e Table of QC data e Table of EQA results e Table of events These tables may be accessed e Through the main menu Current analyte or its shortcuts e By aright click of the mouse on the charts outside a QC point This opens a popup menu with the same options as the menu Current analyte e By a left click of the mouse on any QC point on any EQA target flag or on any icon of the events bar This way has the advantage to directly position the cursor of the table on the row corresponding to the graphical item that was clicked 8 2 Table of QC vectors There are 3 ways to open the table of QC vectors e For any point on the charts move the mouse cursor over the point until it is highlighted in yellow with a visible popup hint and then left click on it e Left click on the main menu Current analyte gt Table of QC Shortcut Ctrl F1 e Right click anywhere on a chart outside a QC point to open a local popup menu and sele
12. It may be sometimes more helpful to install MultiQC twice in two different folders of the same computer ats Delphi Centaur BNP Data entry Currentanalyte Across analytes Maintenance Halfteft Half right Half top Half bottom Full Noname Current GC Archived GC Centaur BHP 45 11 Control parameters In non statistical QC control limits are derived from a set of two arbitrary parameters the target value and the allowed deviation In statistical QC control limits are derived from a set of parameters related to the statistical distribution of the data to monitor These parameters can be a priori known or estimated from a pool of QC vectors In the latter case the pool may be revised and increased whenever a new QC vector is validated floating parameters or locked to a fixed historical reference pool Thus there are four different modes to define the control parameters 11 1 Colour codes for the four control parameters modes pees actos 4 l Each control parameters mode has its own colour code These colours can be changed with the main menu Current analyte gt Charts Style or by right clicking on Floating params params any chart outside a QC point to open a local popup menu with an item Charts m style EET known params EF Urine Calcium 7 ee SCCCCEES 666000660 600008 800008 2 A reminder of the current Glucose so VF Ve TES FPP Feta control parameters mode is Phosphate p
13. Serum LAP Serum Lr atinine l Fill in the grid Proceed column by column going to the next cell with the Tab key the Arrow down key or the Enter key 2 All of the analytes in a profile are not necessarily QCed with the same number of control materials The unused cells of the grid are disabled 3 When finished the Validate button inserts the data into the pending queue which you can validate immediately or later see section 4 4 4 To quit press the button Exit or the key Escape 3 6 Typing in and rating EQA returns through a profile Click on the menu Data entry gt EQA Profile gt XXX This menu is disabled as long as no EQA profile has been created Selecting an EQA profile produces a new entry window with a grid to enter the EQA report analyte by analyte successively tae Enter EQA profile 640 12 Date 21 09 2002 Time 080447 Peers Comment 40 Mark U bar Tolerance 34 67 b40 S enum CEER 640 5 erum i 1 24g l Enter the EQA identification the date and the time when the EQA tests were actually performed 2 Type in the lab result the peer group mean and a possible comment for every analyte At this stage the 17 columns on the right hand side are grey 3 At any time you can rate the entered values with the button Rate to display the rating information in the right hand columns 4 The button Save stores the EQA data on the disk and closes the dialog 5 To quit press the button Exit o
14. e Current data are backed up in the sub folder QC yymmdd hhmmss QCdata e Archived data are backed up in the sub folder QC yymmdd hhmmss QCarchi yymmdd hhmmss QCusers 7 To completely restore the backed up data use the file explorer of Windows and QCusers in the installation directory directory Users settings are backed up in the sub folder QC Erase or rename the current sub folders QCarchi QCdata Copy Paste the 3 backed up sub folders to the installation Fichier Edition Affichage Faworis Bureau Mes documents El H Foste de travail 4 Disquette 314 A H S Disque local C El 3 Program Files E fey Multioc3 Clurrent files 5 E i Olympus AuUe40 E i oc 030606 223809 9 OCarchi 3 OCdata cy OCusers Backup files Data restored from CDs are usually read only Do not forget to uncheck the box Read only in the property dialog of the Windows Explorer else MultiQC will not be able to read the restored files 43 10 8 Archives QC data are self archived when starting a new batch of control material following the method described in section 14 6 It 1s also possible to independently archive any analyte or section e Click on the menu Maintenance Analytes e Select the analyte or the section to archive e Make use of one of the two buttons Archive in the frames section or analyte When an analyte is archived the control charts are blanked except for
15. lt 9 gt Analyte lt 9 gt Date lt 9 gt Time lt 9 gt QC1 lt 9 gt lt 9 gt QC6 lt 9 gt Comment lt 13 gt lt 9 gt is the Tab character lt 13 gt 1s the EOL character Click on the main menu Data entry File of MultiQC and browse to the file to be loaded in the dialog that opens 17 3 Plug ins to import QC data from any text file Analyzers and LIS can sometimes output QC data to text files on a network disk MultiQC can take advantage of this feature to facilitate repeated imports of QC data Unfortunately these text files are never formatted as indicated in the previous section Each analyzer or LIS has its own way to sort data fields Specific programs are necessary to re sort these text files Plug ins are zipped package made of 2 files to be copied to the installation folder of MultiQC 12 Mes documents El W Poste de travail HA Disquette 31 A H S Disque local C E 2 Program Files 9 Carchi fm QCdata QCxxxxxx dll dynamic link library that can read and transfer your data E Carchi 3 Cdata EA MuttiQC2 exe ig unins000 exe Te MultiQC2 pdf 615 Ko 2 MuttiQC2Key tet 1 Ko QCau640 dll 59 Ko Junins000 dat 3 Ko Eula tf 2 Licensing htm QCau640 jini to MultiQC dia Multi 3 Serum Trighye QCxxxxxx ini configuration file which you can edit according to your are own analytes cece Event EQA result Baia proie After launching MultiQC you will see additiona
16. the QC result will be stored but will not be included in the statistics On the charts the point will be pink collared and not linked to other points to show that it has been rejected The button in 19 the row of headers ticks unticks the whole column 5 Refer to section 10 5 for the use of the box Initialize EWMA 6 With the button Edit you can go back to the entry dialog to modify the entered data 7 With the button Pending validation can be postponed The QC vector is enqueued in a file for a future validation 8 Validate with the button OK 9 To quit press the button Cancel or the key Escape The background colour of the grid and of the title denotes the global validity of the QC vector e Gray all of the levels are absent rejected or suppressed figure below left e Green every not absent not rejected or not suppressed level is in control figure of the previous page e Red at least one level is out of control figure below right Operator Moname Unit UL Operator Honame Unit UL patel 17112002 Time 900 2 ne x Ime 00m a QC levels Result Citi Rej Emi l Oc levels Result Ci Re B Sop Multiqual 4 32 5 C Mmultiqual 1 Multiqual 2 49 9 Multiqual 2 Multiqual 3 151 6 Multiqual 3 4 2 Multivariate Validation Hotelling s T is calculated and plotted in the bottom chart Notice that the relative T is charted as the ratio T T limit according to the chosen ARL The global
17. 12345678 13 13 03 Each row of the table can be right clicked or double clicked to open the events window of the specific class 9 7 Keeping latest events when archiving and cloning analytes When a new batch of control materials is started the old QC data is archived and the control charts are blanked except for four kind of events which are kept because the analytical method is always going on working with the former reagents and the former calibration The latest calibration which remains the current calibration of the analytical method The latest reagent lot which remains the current reagent lot The latest verification of the reportable range The latest comparison of methods These three events are thus both stored with the archived charts and duplicated at the beginning of the newly restarted charts Likewise the same duplication of events is performed when an analyte is cloned because the newly created copy of the analyte is assumed to work with the same reagents and the same calibration 26 6 Assessment of analytical performances Does the analytical production of the laboratory meet quality specifications required by customers What is the frequency of non conforming results falling out of the tolerance interval These questions cannot be directly answered considering the results of patient samples which are unknown The assessment of performances relies upon the capability indices computed with the QC results The
18. Click on the main menu Across analytes gt Quality diagnostic to show a list of all the analytes with the relevant performance indexes estimated for each QC material 1 Unfold the drop down list box to access another section 2 Change the sorting order of the list When P or Ppk is selected the first analyte is the analyte with the lowest value of P or Ppk in anyone of the control materials Thus the worst analytical methods are flagged down at the top of the list 3 The date interval for the quality diagnostic may be defined by two extreme dates Do not forget to press the button Apply to take the entered dates into account 4 Fixed date intervals are often more practical The buttons Days back 30 or 60 create an interval of dates back from the current date 5 The current section and the date interval are displayed in the status bar CO g mpus Quality diagnostic mE erifir Section 2700 Serum i Date interval Fined interval Sort by From 01 10 2004 Je A SSS PPI CAP j p min To 1772 2004 E r 1 i3 i3 teo lag 0 615 C Glucose 2 47 i7 6 0 1 223 FAE 19 1 3 6 0 geno Lenn 1 a i 2 1 2 0 12 0 POCONO Nhe tetra ttecke Mercer eter Mir EE u lolx GoT AST 2 Ja 3 0 12 0 LF 3 3 6 3 2 212 0 7 14 4 13 412 0 C_ GPT ALT 2 p 2 4 x 24 12 0 15x 29 O41 F x ks ze sr 2 gs asian lose 4x e 1a 816 2753 C La
19. Customize printing format Each user of MultiQC has his own printing style as Linearity plot style Colors of plot gt Sie tae Cen With this dialog you can customize the on screen style E of the linearity plots Each user has his screen display style Calibration marks auxiliary lines of plot Show grid lines Show dotted line 15 8 Tolerance for non linearity error Tolerance for non linearity error is based on the overall tolerance of each analytical method which is recorded in MultiQC to create acceptance charts and to calculate the capability indexes Non linearity is a component of total error but not the only component So tolerance for non linearity error must be smaller than the overall tolerance to take into account the other causes of error imprecision bias interferences MulttQC makes use of a reduction factor named Non linearity error budget Its default value is 50 This means that if the overall tolerance for serum glucose is 4 the reportable range will be the range where non linearity error does not exceed 2 The actual value of this Non linearity error budget is shown in the bottom status bar of the Linearity window To change it go to the menu Maintenance gt Configuration gt Tab General 63 MultiQC can associate a relative and an absolute tolerance in three different intervals This may lead to complex tolerance areas and discontinuous reportable ranges 15 9 Preparation of s
20. Two additional menus can be popped up Curent OC Table of QC with a right click of the mouse O Archived QC Table of EQA Cent Table of events 16 In the left panel the popup menu n rE expands or contracts the nodes of the tree Limits view UK ME Performance Digosine 17 In the right panel the popup menu U E and al Print charts My Charts style shows the same items as the main menu Contract all r Current analyte T Close 2 2 Shewhart s charts Multiqual 2 l Target line green 2 Upper and lower control limits red They are calculated to get the ARL entered in the dialog Configuration of analytes section 7 1 as explained in the FAQ section 19 3 EWMA red line with its control limits red dotted lines 4 EWMV displayed as grey bars that turn reddish when the imprecision is significantly increased in comparison to the imprecision in the reference historical pool of QC vectors The height of the bars is proportional to the square root of the EWMV 5 Hint window that pops up whenever the mouse cursor hovers above a QC point or a date This QC point is also highlighted yellow The hint window shows the date the concentration and the estimated bias relative difference between the EWMA and the target value 6 Outliers are displayed at the top or at the bottom of the graph in a triangular style 7 Hollow style white cantered indicating that a comment is associated to the QC vector Hover above it
21. a univariate point of view because both his height and weight are normal Obviously he is too big Height and weight must not be considered separately because they are highly correlated They must be associated in a unique multivariate 2 dimension vector 1 5 EWMA and EWMV The exponentially weighted moving average EWMA is a cumulative score that weights the earlier observations successively less than subsequent observations in such away as to automatically phase out distant observations almost entirely The EWMA is both e A statistical process monitoring tool It detects the presence of assignable causes that result in a process shift bias e A forecast of where the process will be at the next time period An estimate of the bias of a method is given by the difference between the EWMA and the target This estimate can be used as the basis for a dynamic process control algorithm to determine how much adjustment is necessary The Exponentially Weighted Moving Variance EWMYV monitors the imprecision of the analytical process 1 6 Plotting QC and EQA on the same chart External Quality Assessment EQA is a service where participating clinical laboratories are sent samples on a regular basis which they test as if they had come from patients Results are returned to EQA centres which provide a report that compares the participant s performance with that of all laboratories using the same test method peer group EQA provides a retrospect
22. analytical method by another one which is not rigorously equivalent is named the non equivalence error It is a component of total analytical error 16 3 How to compare 7 There are two ways to compare split samples assayed by two analytical methods e The scatter plot the values of the new method are plotted against the corresponding values of the current one The mathematical relation between methods is estimated by a regression line The disagreement between methods is measured by the departure of the regression line from the bisecting line of the plot identity line 66 e The difference plot the differences between concentrations in every split sample are plotted against the means of each pair The disagreement between methods is measured by the deviation of the points from the horizontal nil bias line 160 2 0 E E 150 u 1 0 O 0 O x I 140 3 00 5 LL 2 1 0 130 120 2 0 110 gt YF S Y Sf YF SS SF Mean mmol L Ref method mmol L Comparison of two serum sodium methods difference plot on the left and scatter plot on the right Same data Both methods have pros and cons They provide complementary information CLSI former NCCLS has published guidelines for method comparisons where both scatter plot and difference plot are advised 16 4 Tolerance polygon Medically acceptable error is a basic figure whose knowledge is essential to a cost effective management of qua
23. and sorted like patients reports Therefore it is more convenient to manually enter QC data in MultiQC level by level as they are printed out The program can create entry profiles made of several analytes sorted in any order Likewise some EQA providers return reports every week in the same format An entry profile is also very useful in such a situation To create a profile of analytes sorted per your patient reports or your EQA returns access the menu Maintenance gt Entry profiles 15 att MultiQC Create or edit entry profiles Eg Available analytes ai OC profiles EDA profiles 2700 erum Contents of QC profile List of OC profiles Acide unique ALP section Analyte fU0 Serum Acide unique ee SP aosenm ALP k cai fU0 Serum Ammoniaque Bicarbonate Add to 2700 5 ame profile Serum Amylase Bili dir 2r 00 Serum Bicarbonate Bili tot 2r 00 5 erum Bili dir Calcium ae fO0 Serum Bili tot Chlorure Chol HOL Chol LDL ee Cholest rol drag CK and CRP drop Lr atinine Fer GGT Glucose GOT AST T Delete line s Delete all GPT ALT Lactate Name of profile Profle 2 15 Delete profile LOH 5 lt l 40 Sort analytes gt Creating a profile l In the Profiles dialog select the tab QC profiles or EQA profiles 2 Drag analytes or a whole section from the tree view on the left and drop them in the center panel 3 Sort the analytes now showing in the center pane
24. borders the number of non conforming results is expected to be negligible gt Performance flags Flag PporPpe Quality Comment on the analytical method Highly capable Can work out of control up to a 7 mite Meme point LTA STC chart is advised 131020 Good Capable but needs a conventional QC to continuously stay in control 10to13 iasumiciont Theoretically capable but practically prone to non conformities with the slightest drift or shift Less than 1 0 To be improved 28 7 Definition of analytes 7 1 Creating an analyte Click on the menu Maintenance gt Analytes to open the dialog Definition of analytes ais MultiQC Configuration of analytes Section Analyte 1 Type in the name of the a Calcium Delete Clone section where to place the new b mem analyte If this is a new Decimal places 1 section 1t will be created in in a show table of anabtes the tree view of the main window else the analyte will Control method In control ARL be added to a pre existing GCLevel IE Statistical QC Shewhart 8 section Smoothing factors Univariate ae 2 Type in the name of the Ewa Multivariate Savi LT4 STC O analyte Two analytes with the EwMV Non statistical QC Hoteling same name cannot be created in the same section E Create analyte Update analyte HL Exit fl 3 Enter the number of C Program Files MultOC4 0Cdata LILHYR Q8 gef decimal places This number
25. by dragging and dropping them or using the up and down buttons 4 Name the profile 5 Validate with the Create profile button gt Editing a profile 6 To add an analyte to an existing profile select the profile in the right pane and work like in 2 7 To remove an analyte from an existing profile select the profile in the right pane select the analyte to be removed in the centre panel delete it with the button Delete line s or press on the key Del 8 After editing a profile do not forget to click on the button Update profile for the changes to be taken into account 9 Any change may be reversed with the button Undo as long as the dialog has not been closed 10 To quit press the button Exit or the key Escape 3 9 Typing in QC data through a profile Click on the menu Data entry gt QC Profile gt XXX This menu is disabled as long as no QC profile has been created Selecting a profile produces a new entry window with a grid to enter the analytes level by 16 level successively Over long lists are common causes of mis entries so should be avoided It is often better to create two middle sized profiles than a single longer one us Enter QC profile Profile 1 Date FEA0 2003 Time 08 37 42 2 Section Analyte QC1 QC QCS Comment 40 Serum Acide urigue Serum Albumine Serum ALP Serum Amylase Serum Bicarbonate Serum Bili dir Serum Bili tot Serum Calcium Serum Chlorure Serum Cholest rol Serum LE
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27. final aim is to flag up the analytical methods which need to be improved because they are unable to meet the allowed tolerance 6 1 Tolerances Every analyte is created with a default allowed error of 10 This tolerance value must be replaced by the actual tolerance which generally comes from the EQA provider of the laboratory Tolerance is needed e to calculate capability indexes e To draw LTA STC charts e To evaluate how acceptable are the biases of the analytical methods as measured by EQA returns To enter the tolerance data for an analyte go to the menu Maintenance Tolerances This opens a dialog where you can define i MultiQC Tolerances of analytes the tolerance for each analyte within 3 ranges of concentration v a l Within the whole analytical range first 2 And or within two specified intervals 2 rd pia 3 This tolerated error may be relative default value 10 or absolute If both fields are filled in the program uses the greatest allowed error for the concentration under question This means that relative tolerances apply to the higher end of the range and that the absolute tolerances apply to the lower end of the range row General 4 When changing the tolerance of an analyte the previously entered EQA target flags are re evaluated if the box is checked 5 Do not forget to press the button Apply to validate any change in the dialog Tolerances of analytes 6 You can have a look at the
28. in the current Analyte They are also inserted in the provisional Analyte if at least one IQC vector of Analyte is dated earlier than the EQA result Remember that EQA target flags are drawn in comparison with the mobile average and cannot be drawn if this average is not available at the time of the EQA result 14 5 Cloning analytes one by one In the above section cloned analytes are automatically created when they are used for the first time It may be sometimes helpful to manually create cloned analytes l To clone an analyte simply select this analyte in the tree view and access the dialog to administrate analytes menu Maintenance gt Analytes Poi AL Phil Curent OC A 0 Curent OC C Archived OC Archived OC El Chemistry El Chemistry Bicarbonate Bicarbonate Chloride Potassium H Sodium Hematology ne Platelets iiu MulttOC Parameters of analytes Section ib alyte Chemisty 02 Chords 2 Cone FE 4 Unit mmol B Table of analytes 2 Click on the button Clone in the analyte frame 3 So you create a clone of the selected analyte in the same section This cloned analyte is free of QC data 4 It is possible to simultaneously clone all of the analytes of a section by selecting this section in the tree view and then by clicking on the button Clone in the section frame 14 6 Switching to a new batch of control material When the older batch is exhausted e Access the Analyte
29. new z onamne ALP checkbox is displayed in the top left corner of the main STE a Amylase window At any time you can manually uncheck it to end 6 pee ac v Calcium Chlorure LE LAP GOT AST LOH Lipase Potassium Sodium ALP Amylase Calcium ER LAP GOT AST LDH Lipate Potassium S odiuim the re direction Entry to Analytes Derma Bili tot Cholesteral CK Redirection of data entries concerns e Manual keyboarding of IQC profiles e IQC data retrieved from a text file by a plug in see section 17 3 e IQC data received on line through a serial QC receiver interface refer to section 18 Redirection must be activated before transmission of results by the analyzer e IQC data sent to MultiQC working as automation server Duplicated analytes are automatically created if they do not exist They may be directly accessed through the tree view of analytes like regular analytes for entering editing single IQC vectors 56 14 4 Automatically duplicating EQA results in Analytes and Analytes When two batches of control materials are coexisting thanks to duplicated analytes EQA target flags must be simultaneously plotted on the QC charts of Analyte and Analyte This is automatically done with a single entry of EQA returns when data are typed in an entry profile or directly sent with software like Riqas To MultiQC see www multigc com EQA results are always inserted
30. performed later see section 13 3 gt Editing a remark wis MultiQC Remarks 1 The left tab History of the remarks rs ry 640 Serum Albumine window shows the cumulative history of remarks itos New remark 2 The table of remarks and the Bes dite REEN i 167 062004 11 00 00 Changement lampe Phil events bar of the main window ae 09 00 00 Clot detector remis en service Sarah synchronized If you click on a row 16 09 2004 10 00 00 Maintenance Olympus Pat in the table the corresponding icon 16 00 00 4 Changement lampe Phil of the events bar at the bottom of the 29 09 2004 15 25 57 Etalon IFCC 4 Beber main window is highlighted and vice 06 10 2004 08 00 00 Calibrator lot 109 Sarah versa eff 2005 10 00 00 Maintenance Olympus Sylvie 09 05 2005 12 00 00 Intervention panne m lang Beber 3 You can edit a remark only if you ef r 052005 10 00 00 Changement lampe Phil are a supervisor or if there is no supervisor Press the button Edit or double click on the line to edit in the list view of remarks 4 To delete one or several remarks select the relevant lines with the mouse Shift click and Ctrl click for multiple selections as usually in any Windows program and press the button Delete or the key PE Del A local menu can also be popped up with the right S button of the mouse History Hew calibration Date Time 5 4 The calibrations window P Full calibration Reagent blank The calibrations wind
31. reference pool of data Please refer to the following section to learn how to start a new batch of control material 4 The button Material utilized by shows which analytes are controlled by the material selected in the grid above the button 5 The button List of materials displays the list of all the analytes with the relevant control materials Printing this table is also possible 55 14 2 Starting a new batch of control material A good laboratory practice is to start a new batch of control material before the current one is exhausted So during a few days or weeks it 1s necessary to separately collect additional QC data for the new batch while keeping on controlling analytes with the older batch Two sets of QC charts must temporarily coexist for the same analyte MultiQC has a built in easy way to manage this duplicated QC by duplicating the analytes It is designed to apply to the most frequent case when all of the levels of control material are simultaneously changed Refer to the frequently asked question section 19 if it happened that you had only one level to re start A clone of each analyte 1s created to allow starting new QC charts without breaking off the current ones The clone is used to store QC data relevant to the new batch of control material during the time necessary to collect an adequate reference pool When time occurs to switch to the new batches the older charts are archived and the clone takes
32. spreadsheet according to the following pattern one QC vector per row A 4 Serum GGT TEI 11 41 ET E 7 TI 115 7 peer 2 Serum GGT 12 12 2001 16 49 37 27 27 76 75 114 114 3 Serum GGT 13 12 2001 10 34 28 27 26 76 76 113 112 MA Urine Cr atinine 06 08 2001 09 13 51 0 83 0 83 2 25 2 24 fS Urine Cr atinine 07 08 2001 13 43 55 0 81 0 8 227 22 A Section name only the first 12 characters are used B Analyte name only the first 12 characters are used C Date the format is the short date format set in the locale parameters of Windows D Time if the time column is blank or incorrect the default time 12 00 00 is used E to J Concentrations for the 6 control materials QC1 to QC6 Let blank if unused K Comment it is truncated to the first 40 characters 1f it is longer than this The first three columns are mandatory Incorrect rows are ignored gt Importing l In Excel Select the rows to copy or the whole spreadsheet with Ctrl A and click on the menu Edit gt Copy blank columns or rows are ignored 2 In MultiQC click on the main menu Data entry gt Paste The data will be retrieved from the clipboard You can validate immediately or enqueue data in the list of pending data for a later validation 17 2 Importing from a pre formatted text file MultiQC can load QC data from text files which are formatted with the same pattern as the Excel spreadsheet in the previous section Section
33. the latest events as indicated in section 5 7 1 To consult archived QC data check the box Archived QC 2 Archived files are sorted in a 3 level tree view by ait MultiQC 2700 Serum Lipase H i ar Tat a se a ae J e Section name Current archive Mofa ia Screen Phil Unarchive 3 Delete archive 4 Purge archives e Analyte name Current GC Archived OC e Date of the first QC vector and number of vectors 2700 Senm Amylase Cholest rol GGT GPT ALT Lipase 30 03 2004 445 Charts style ys 3 With the menu Maintenance gt Unarchive it is possible to re send an archived file among the current files to be edited or reprocessed To prevent duplicated names the section name becomes Section with a leading You can re archive the unarchived files when re processing 1s completed 4 Click on the menu Maintenance Delete archive to erase any no longer necessary archive file 10 9 Automatically purging old archived files After several years of QC archive files are accumulating in the folder QCarchi of the installation directory of the program The ais MultiQC Purge old archives Section Analyte Fror 4 to menu Maintenance gt Purge archives triggers an automatic purge of the folder from the oldest files OBB o 640 Serum 2r O0 Serum Ar 00 5 erum 2r 00 Urine Centaur Bicarbonate Chol LOL MM agn sium Lr atinine 22r 01 2003 057 1272001 057 1272001 10701
34. the place of the regular analyte A cloned analyte is an analyte created on the pattern of a pre existing one but named with a leading Cloned analytes Analytes are shown in the tree view of MultiQC like any regular analyte They keep the parameters of the mother analyte and the latest events as indicated in section 5 7 If the control mode is not Known params it is reset to statistical QC with floating parameters 14 3 Redirecting IQC data to Analytes l Every time when you are assaying the new batches of control materials you must tell MultiQC that the next QC data to be transmitted by the Redirect entries to Analytes to store the i QC data of a new lot of control material analyzer must not be stored with the current data Click on the main menu hase Data entry gt Entry to Analytes As soon as the button lt OK gt of the EE a eee ne confirmation dialog is pressed all of the QC results are re directed to the onela Confirm cloned analytes E O hrer 2 hous 2 According to the box checked in the dialog the re direction will be Pieva automatically ended one or two hours later Be careful if you check the box lt Never gt Practice in the author s lab has shown that technicians often forget to manually stop re direction to Analytes which leads to a mixture of batches the day later when the current batch of QC material is assayed again EG Serum When the re direction to cloned analytes is active a
35. the process target but this target is unknown at this time MultiQC uses an algorithm that revises the EWMA starting value as QC progresses The first EWMA value is e The first QC value when only one point has been entered e The mean of the 2 QC values when 2 points have been entered e The mean of the 3 QC values when 3 points have been entered e The mean of the first 10 QC values when 10 points or more have been entered 40 Mean of the first 10 points EWMA starting value H E r l 3 The EWMV is initialized likewise The EWMV bars are displayed only after 10 different QC points have been entered to cut non significant signals that might be triggered when a chart is started 10 5 Re initializing the EWMA It is sometimes necessary to re initialize the EWMA when a known event occurs that causes an abrupt shift in the analytical output Changes of reagent or calibration material Adjustment of the calibration to compensate for a drift or bad EQA reports Calibration Fe l e el ee E Ut ai 1 Without re starting the EWMA line follows the shift eee ee eed caused by calibration with a time lag because of its inherent inertia 105 2 A false increase of imprecision is flagged by the iE EWMV bars The EWMA can be re initialized Edit comment e in the menu that pops up when right clicking on a QC point eee p e In the QC vector entry dialog section 3 2 or in the validation dialog section Initialize EWM
36. to learn the three ways to define this SDsr The EWMV is disabled in LTA STC charts because there is no defined reference long term SD_r to test the moving variance 7 4 Non statistical QC In non statistical QC the target value and the deviation allowed around this target value are arbitrarily entered without any connection to analytical variability Hon statistical QC Non statistical OC charts are created with default parameters Target 10 Allowed deviation 1 Control method Statistical QC Univariate Multivariate LT4 STC Hon statistical OC Ge Go to the menu Maintenance gt Control parameters This is a simplistic way to QC an analytical to enter the actual values method generally relying upon data provided by the maker of control materials The process is assumed to be acceptable whenever the assay of the control material falls within the interval target allowed deviation Non statistical QC 1s always univariate correlations between control levels are not taken into account When a new analyte is created the default target value is set to 10 and the default allowed deviation to 1 After creating the analyte with the button Create analyte use the menu Maintenance gt Control parameters gt Known parameters to enter the actual values The EWMV is disabled in non statistical QC because there is no defined reference SD to test the moving variance Likewise the control limits of the EWMA cannot
37. 1 05 2004 11 00 00 ar ae 3 26 05 2004 11 00 00 i 03 06 2004 11 00 00 Sroup By analytes Fa 10 06 2004 11 00 00 Group by dates 02707 2004 11 00 00 JC 2270 227 00 Bicarbonate Bili dir l Data can be sorted by analytes or by dates through the main menu Group or the local menu which pops up when right clicking on the table 2 Each node can be expanded collapsed by clicking on its sign 3 All the nodes can be expanded contracted through the main menu Nodes or the popup menu 4 By default the interval of dates includes the two last full months and the current month but this can be changed to any range of months or dates 9 4 Statistics for a given period 44 MultiQC Statistics across analytes Style Print Export Exit Section 2700Seum Date interval Fixed inter E a Show From 01 10 2004 ma T 30 30 days back back 60 60 days back back All SO Number 5 pply 5 To 31 10 2004 gt CY Mean 2 2 1 3 36 83 16 0 91 1 1 39 1 2189 0 0127 1 0 35 m EF NV m SO CF Nv bu SO id Statistics of 2700 Serum from 01 10 2004 to 31 10 2004 37 l Four parameters m SD CV and N are displayed Anyone can be hidden by unchecking the relevant box The range of dates can be set to the latest 30 or 60 days 2 any month 3 any range of days 5 or the whole set of QC data 4 6 Displayed statistics can be printed or exported to another program 9 5 Other tables
38. 72003 0370972002 ear 032003 0370672003 2170272003 arr 03 2003 137 1172002 1 Choose the number of years of QC to keep on line Find old OC files QC files older than Ears Files to erate Tick all lines Untick all Send ticked files to 5 the recycle bin 2 Search for all the files to erase They are listed in the window if the last recorded QC vector dates before the first date to keep on line 3 Lines can be individually selected unselected with checkboxes 4 The columns From and To show the dates of the first and of the last QC vectors for a given file 5 Selected files are sent to the Windows recycle bin when they are erased Thus they can be restored in case of error 44 10 10 QC of two instruments performing the same analytical methods This is a frequent situation in general clinical chemistry or in blood gas analysis An important task for the QC supervisor is then to frequently review and compare the same analytes on the two analyzers MultiQC has a feature specially intended to facilitate this job The main menus Screen gt Half left Half right Half top and Half bottom shrink the main window to a half screen Thus it is possible to simultaneously display the same analyte QCed on two analyzers each one on a half screen If the number of analytes is not too high you may create a section for instrument and a section for instrument 2 and launch MultiQC twice to display both instruments together
39. A 4 1 ase OC vector Close 105 LAs A Any point of initialization 1s recognized on the charts by i Py ar a broken EWMA red line 100 ii wen T RITT p 4 Ge cil ae Ge ee IT 3 The EWMV is not re initialized but calculated relating wake danai sia isla a Gnd Od Vd Kula kW to anew shifted EWMA There are no longer alarms of 95 Ey imprecision in the EWMV bars 10 6 Backup The usual way to back up data is to use a specialized network hard drive A USB stick may be more practical Each analyte needs a few tens of KB The size of the file may reach 100 KB after one or two years of daily QC without restarting a new batch of control material Hence each backup for the whole set of analytes may need a disk space up to a few megabytes 41 as MultiQc Configuration General Events QC comments EDA comments oie backup Analyzers Retrieve data from other versions l The backup disk and folder are preset in the configuration dialog Click on the menu Maintenance gt Configuration and select the tab Backup directory Backup Ewa 2 2 Button to browse to the backup folder You can only select an existing folder of the local disk of a remote disk or of an external storing device It is sometimes useful to create a backup sub folder Its name must be entered with the keyboard in the left entry field In the picture E was obtained browsing to an USB stick connected to the computer and MultiQC backups was type
40. Ges acti tenant hse a esas Nea se Doeawen Lad AR eseewtdande 46 11 3 Statistical QC with a reference POOl cc cceecccceeccceeceeceeeeceeeeeseeeeeceaeeeseaeeseueeeseacesseneesseeesseeseeseneeess 47 11 4 Statistical QC with KNOWN parameters ccc eecccceececceeeeceeeeeeaeeeeceeeeeceeeeceeeeeseeseeseeeesseeeesseeeseeeeeseeeeeas 48 11 5 Distinctive feature of the LTA STC chart ccccccccccccssscecceeseeeceeseeeceeueeesseaeeessageeessageessegeeessegsseeenes 48 11 6 Offsetting the target Values ccscetcecitamcesed ostcieees cata a esata a a aai aaa a iaa 49 12 Operators and logins isisa a ee este ae ah ee ee aceseetee eae 50 U2 tite EOIN Meeren E A scaman ani ewncabatennuauaed apiaamerb eden maw anaaiantt 50 122 Creating OGINS nase a a a E a teehee A 50 12 3 JCUSTOMIZALION OFIOGINS DY USERS reni a E a a E O idence E N R taeent 51 13 Gener l conng ratlON sssi a aie a aa aa addaa oae iaaea 52 Tols CGonigu uraion dialogerna E a E a aan 52 13 2 CUSTOMIZING GiSplay and PAMOU eisni a a a a a 53 MSs INGEWORKIPG WI MUOG Siinain n a cans adie Miteanceeansaeees 54 14 C ontolmaterals sensim a 55 TAk COMUOI MALS NS esee are hte had a a a a A att ane Ace otal 55 14 2 Starting a new batch of control Material ccc ccceecce ce eeeeeceeeeeeeseeeeeeaeeeeeeseeeeeeeeeeeesseeeeeeseeeeeesaeeeeeeeas 56 143 IRediIreciing IOC data to AnalVies cicatit i siisa halt athe aca aa edhe cl a iol a elec ita
41. MultiQC 5 2 User Manual M litiQC 2 Us r I AUN coc acct ectiaccseccisnciecSieucdecseecsdeccseccsecsvessceseeesssedseesasesduesesencuenesegcterecegstec 1 te COICO OES aane NE EEA AA 4 1 1 Long term and short term variability ccccccsescccssececeseceseseeceseeeeaseeseaeeeseeceneseeesaceessaseesseeensuetenaess 4 1 2 Process capability and process performance indexes cecccceeeccceececeeeeeceeeecseeeesecessueeesseeeseneeesaeees 4 1 3 importance of performante INDEXES geciaics seccastoscuersdensaed shensueesedancsciesnensusesdebeceans couedshaneteds stab mud Aa a 6 1 4 QC vectors and multivariate QC cccccccccccccssssecececeeseeeeecceeeeecceeaaaeeeeesseueceeesseaueeeesssauecesssseaeeeseesaaagass 6 1 5 EWMA and EWMNV ecarri ennienni E Ea aaa E a EE EEEO aE EEEE EEEE 7 1 6 Plotting QC and EQA on the same Chat cccccccccccccseeeeeeeeeeeeeeeeeeeaeeeeeeeseeeeeeeeeseeeeeeeessseeeeeeesaaaeeeeeeeaas 7 1 7 ETAS TO CNA rs ops eines cere ie ee vere dese dec pe N en acts EEE E E OEA 7 1 8 What abo t the QG 2 aca sesc see actos a iiaa ae SAE E Aaa EEE AEE E ndeeueates 8 1 9 Engineering process control ccceccccseeeceeeeeeeeeeeeeeeeeceeeeeseeeeeseeeeeseeeeseaeeseaeeeseaeeeseeeeeseeeeeseeesaeeeeeseneensees 9 2 CONTONA Seo EE E cme EE E E E Erei 10 2 1 CA WIG OW seer EE E E E A E E E eareoeneee aces 10 2 2 Shewnait S CNAS sesuipsana tretin i aa iE aaa aaa aaa aa aa iaa ai 11 Zio Clicking on the char
42. Out of tolerance pair In tolerance pairs lt lt 3 mmol l tolerance lt lt 5 mmol l tolerance Allowed total error Concentrations lt 130 mmol l 5 mmol l 130 to 150 mmol l 3 mmol l gt 150 mmol l 5 mmol l Difference plot with its tolerance polygon Comparison of two serum sodium methods gt Scatter plot Building a tolerance polygon on a scatter plot is less straightforward The aim is to evaluate the departure of the regression line from the identity line In routine laboratory work slope and intercept of regression lines are generally calculated from a set of say 30 to 100 samples Random error on regression lines is thus minimized to put non equivalence error in prominent position So the error allowed for a regression line is smaller than the total error allowed for individual concentrations MultiQC makes use of a reduction factor named non equivalence error budget Its default value is 33 This means that if the overall tolerance for serum cholesterol is 6 the criterion allowing the interchange between two methods will be non equivalence error less than 2 The tolerance polygon is built on a scatter plot with this reduced tolerance It frames the bisecting line Interpretation of a scatter plot does not depend on individual points but only on the regression line Any point of this line which is inside the tolerance polygon satisfies the commutability criterion So the commutability range is
43. a Scarica acta seit ean eterna ease dea A 37 9 4 Statistics for a given DEMO sesso rna is aeiteegis eae we ae Seas ore eased atin 3 7 9 5 Other tables Across analytes seocGscto da sieecc secdecedvechsdouccecs Youd sax depute sseaeatodesceucs vax coaeacealecnasbovesseeeech erase 38 10 Speci l MAaNAGeIMeNE OF datai iiaa pade a Aa aE aE EA Aaa 39 19 1 Editino ord lting a QC Vecto cenen a a eee 39 10 2 Editing or deleting EQA results or events ccccccssececcsececceueeeceeseeeceeuseecseuseeessugeeessaesessegeeesssnsseeeeas 40 10 3 ErasmgacrossanalyleS eana a A eyes AE 40 10 4 Initializing the EWMA and the EWMV ccccccccccceceseeeeceeeeeeeeeeeeeeeeeeeeeseeeeeeeeesaaeseeeesaeeeeeeeesaeeeeeeeeaas 40 105 Reantalzno Me EWM A issa i a a ele a des a nas o a a a 41 10 6 Baek ecciesia aa a O 41 10 e TIRE SUOMING se e a a E aaa ap a 42 19G ACHIV aaa A a a a a a a E T A E A A N 44 10 9 Automatically purging old archived fileS cccccccseecceeeeeeeeeseeeeeeeaeeeeeseeeeeeeeeeeeeeeeeeeeseseesseeessaaeeeeeeas 44 10 10 QC of two instruments performing the same analytical Methods ccccseeeeeseeeeeeeeeeeeseeeeeeesaeeeeens 45 Ti Control parameters i tcicscicssaces ioe sg Seas oct cccan au a A A A 46 11 1 Colour codes for the four control parameters modes cccccceeececeeececeeeeeceeeeseecesseeesseeeesaaeeesaeetenes 46 11 2 Statistical QC with floating parameters lt ccse5 sdcwcen Soda un
44. a entry i Remarks Phil t Remark Curent A Calibration Srchived Cj Reagent lot New reagent lots iS e e r Calibrations and reagent blanks g PR Repeatability L Verification of the reportable range ne Linearity l amp Compariso F Comparison of methods a ia ie i Ie R Repeatability oy Alevents Ctrl4F3 Each kind of event has its dedicated events window both to enter new events of the same kind and to display the cumulative history of these events These events windows are opened by clicking on the relevant submenus of the main menu Events 5 2 The event bar Events can also be accessed through the event bar located in the main window under the row of dates The event bar is a made of double row of icons which one pointing out the occurrence of an event The lower row is reserved to calibrations When hovering above an icon with the mouse this icon is highlighted yellow and a green hint shows the date and the caption of the relevant event When clicking on a highlighted icon the relevant event window is opened Events do not modify the scale of dates of the QC points Icons do not use a reserved column of the time plot They are placed below the next Calibration QC vector that might be affected by the event f Remark ie BC 645 Several events may occur at the same time Their icons should be superimposed in the events bar Practically they are replaced by a special ij X Close icon Clic
45. alidating a QC vector l The global univariate s Lypho uri 1 Ra i validity as explained 27 e n as an Uperator Honame Unit mmalL 17 ae above 2 No capability alarm oe The bottom row of the grid shows the lowest QC levels Result Cpk value observed Lypho uri 1 26 4 among the control Lypho uri 2 110 0 levels The number of Cpk 2 the relevant level is displayed between Lypho uri 2 d a brackets 2 on the Initialize Ewha 62152 picture An exception T eee is raised if this lowest Edi fo st 1 6 r ee chale section 7 3 to enhance the default threshold 1 Acceptance interval Icons that show whether the capability of the analytical process is high enough to meet the specifications This icon is red if the lowest Cpk value among the QC levels is less than the threshold entered in the Analytes dialog default 1 3 The control interval of a LTA STC chart is based on the latest known EWMA and three short term a Control The C value taken into account for the acceptance fe eee interval test is the C value that would be observed assuming that the QC point under validation is accepted Latest known QC point under validation 21 4 4 Validating a set of QC vectors from the pending queue The pending queue of MultiQC is a FIFO file First In First Out that stores QC vectors e The validation of which was postponed by the button Pending of the vali
46. alyte files to search for the items to delete Without this function it would be very tedious to have to open every analyte one by one to erase the wrong items Erasing across analytes 1s only accessible to supervisors Open the window Erase across analytes by clicking on the main menu Across analytes gt Erase across analytes tau Erase across analytes l Left click on anyone of the graphical items to Peer Gece ene Cen erase IQC point EQA target flag or Event icon EGA target flag or Event to select the kind and time of the data to erase Erase all QC vectors Entered on 26 05 2003 14 16 02 2 The foreground dialog is immediately updated with the kind of data to erase and the date time of the wrong items 3 Press the button Erase to delete all the items of the same kind and date time as the clicked highlighted item A confirmation is requested before irreversible Confirm erasure When scanning the different analytes MultiQC can meet a busy analyte 1 e an analyte p Found 7 items to erase currently processed by another workstation of the ae pseu veg SPREE ESE 640 Serum Calcium network In such a case the erasure action 1s postponed and enqueued to be performed later 10 4 Initializing the EWMA and the EWMV The EWMA associated to the first QC point in a Shewhart s chart is somewhat arbitrary The iterative formula fails because there is no previous QC point A possible starting value might be
47. ame random variability as any other assay Target flags draw a secondary chart superimposed on the regular Shewhart s chart The decision to compensate for an analytical bias must be based upon a series of EQA signals in agreement Compensation is particularly necessary when facing red or yellow target flags The theoretical aim would be to get a EWMA line cantered amid the target flags So the analytical method would be cantered on the mean of the peer group The chance to successfully pass the next proficiency testing 1s maximized When the commutability of the EQA material is disputable the relevant target flag must not be taken too seriously An EQA target flag cannot be displayed if there is no QC point before because the average output of the analytical process is still unknown EQA returns cannot be validly interpreted if the analytical method was not stable in control when the assay was performed It may not be correct to extrapolate the bias of an EQA assay near the higher end of the reportable range in order to adjust the target of a QC material near the lower end of the reportable range Therefore the main window of MultiQC provides a choice see picture on the right between displaying EQA target flags grouped on chart 1 drawing on every chart or drawing on the QC chart with the nearest target value EQA target flags are placed on each control chart in comparison with the mobile average So they cannot be drawn if this ave
48. amples with equally spaced concentrations The most precise way to mix low and high concentrations pools to produce samples with equally spaced intermediate concentrations is sequential mixing A middle pool is obtained by mixing equal volumes of the low and high pools Then the middle pool is mixed with the high and the low pool in equal volumes to produce a mid high and a mid low pool Thus a set of five equally spaced concentrations is made up A set of nine equally spaced concentrations can be easily prepared mixing again the adjoining samples of the set of five concentrations High pool 900 ul Low pool 900 ul J UC 200 ul of five equally spaced dilutions The volumes in the above dilution scheme should not be reduced to keep a good precision Conversely it is highly recommended to work with higher volumes if enough pool is available Increasing the volumes is also required for the preparation of a set of 9 equally spaced concentrations which requires a third dilution step Sequential mixing is very fast accurate and precise even with volumes as small as 100 ul Errors might come from the nature of pools materials which generally have a high viscosity and a tendency to foam easily These issues are overcome by using the reverse pipetting technique to dispense materials and by a careful mixing of tubes A bias in the calibration of pipettes is not harmful because of the principle of mixing equal volumes from the same pipette
49. be drawn 7 5 Editing deleting an analyte or a section Click on the menu Maintenance gt Analytes to open the dialog Configuration of analytes While editing a section or an analyte the background charts remain active The analytes can be changed the charts can be scrolled and the hints can be opened hovering above the points with the mouse 30 gt Editing deleting a section Select the section to be edited in the tree view of the main window The four buttons of the frame Section become enabled e Rename to change the name of the selected section e Delete to erase all of the analytes in the selected section e Archive see section 10 8 Section e Clone See section 14 2 n2 gt Editing deleting an analyte Select the analyte to be edited in the tree view of the main window and change the required fields of the analytes dialog After editing an analyte do not forget to click the button Update analyte The charts in the background window are immediately updated If you change the section name the analyte is moved to the new section which 1s possibly created if it is a new one Special functions are available in the the frame Analyte Analyte l Delete to erase one analyte E1 Clone 2 Archive see section 10 8 Decimal places 2 3 Clone see section 14 2 Unit al ov B TE Table of analytes 4 You may have a look at the parameters of other analytes with the button Table of analytes 7 6
50. bove the points with the mouse ai MultiOC Administration of control materials 4 Edit Create Registered control materials Assign to Name Lot gt GOSS Name LiChek CRP 1 52261 You Multiqual 1 LiChek CRP 3 52263 may fa Bo LiChek Uri 1 bare Max characters 12 LiChek Uri E2707 drag Name Lot Multiqual Pe Multiqual 1 rt Multiqual 2 46312 5 Muligual 2 Multiqual 3 46313 N Hultiqual 3 Max characters 10 Assign Clear fields 2 Material utilized by x Update z Delete unutilized materials Lowe List of all materials ff E xt l Create the control materials in the left hand panel When pressing the button Create the new control material is inserted in the list of the centre panel 2 Assignments are done with the button Assign or by dragging and dropping from the centre panel to the desired QC level in the right hand panel You may assign a control material either to a unique analyte or simultaneously to all of the analytes of a section For instance in the picture above the target analyte is the direct bilirubin of the section 640 Serum but it should be possible to select the section 640 Serum to simultaneously update all of the analytes it contains 3 When you change the lot or the name of a control material there are two possibilities Either it is a simple correction of a mis entered name or lot and you must use the button Update Or it is a true change of lot with a consecutive resetting of the
51. closing the window Menu Exit key Escape or Windows Close box without performing a complete validation the remaining not yet validated QC vectors are inserted again in the pending queue and the panel Pending data blinks again Significant drift 4 5 Monitoring the EWMA Drifts and trends are frequent in clinical chemistry They may lead to an unacceptable number of non conforming analytical results The EWMA curve is a good tool for signalling such insidious errors that are not or lately flagged by conventional QC charts EWMA control interval Exceptions raised by a EWMA curve often do not need an immediate corrective action This action may be postponed if the capability of the analytical process is high enough However a daily review of QC charts is necessary searching for drifts or trends picture on the right as soon as they occur The old practice of reviewing the average of analytical processes only once every month is inadequate and should be replaced by a much more frequent inspection of the EWMA curves 23 5 Analytical events It is necessary to be acquainted with certain analytical changes and verifications to fully understand and efficiently troubleshoot the hitches displayed by QC charts MultiQC can log these events Thus they are easy to consult through the main menu Events and through the events bar 5 1 Events logged by MultiQC The analytical events logged by MultiQC are divided into five classes Dat
52. ct Table of QC CO Olympus 2700 Serum Albumine AEA Honame ka Curent GC ile as archived CY eT ah AS N 2700 Serurn A ia PBS Ba ie wy Acide unique yt 2700 Serum Albumine Albumine 22 0 ALP H Date Time GC QL Tec Ammoniague Sg 154 15 04 2004 10 47 54 22 58 40 50 Amplase gt 43 0 155 16 04 2004 10 47 54 2291 4164 lt Bicarbonate 425 lM A ohh al 17 042 10 47 54 2297 41 76 i 7 ar ee O a E TE A TET 2 2308 AA a S s iea e 158 19 04 2004 104754 W 2271 421 ACIU a 410 4 159 20 04 2004 10 47 54 4 23 30 W 4250 Chal HOL 160 21 04 2004 10 47 54 2316 41 95 Chal LDL TPA Sar ararareye oY 161 22 04 2004 10 47 54 2290 4165 Cholest rol F amp 162 23 04 2004 10 47 54 2309 4168 CK 163 24 04 2004 10 47 54 2315 41 92 e FAA o0 D a05 2004 164 25 04 2004 10 47 54 2317 4p 43 00 i a Number of lines 200 Fer s E Trial period you have 44 days left of your 60 day evaluate 32 l The table of QC vectors and the background charts are synchronized If you click on a row in the table the relevant column of QC points in the charts window behind is highlighted and vice versa Refer to section 1 for the significance of coloured deviation icons The background colour of a row is red whenever the relevant QC vector is globally out of control Note that the colours depend on the status at the time of validation If the control interval is chang
53. ctate 2 2 5 2 2 2 12 0 3 gt mex 12 21 3 K 2 9 x 2 8 12 0 a Fired interval 7 1 9 16 120 f C LDH 2 23 2 2 12 0 7 25 232 420 i 2 0 2 0 24 5U L C Lipase 2 e2 7 27 15 0 3 3 3 0 2 9 15 0 ZSL 0 9 7 5 Date interval LA Phosphate 2 1 3 amp i6 7 5 E mao 37 2i 19 7 5 i 2 5 24 10 0 to 1771272004 L Potassium 2 2 3 2 1 5 0 Histogram classes 3 13 16 5 0 i i6 15 4 0 a C Sodium lz fe24 1 9 4 0 lt e 7 1 3 1 3 4 0 Phosphate mg L OC of 2700 Serum from 01 10 2004 to 17 12 2004 From 01 10 2004 to 17 12 2004 6 Refer to section 6 2 for the significance of the performance icons 7 Checking a box before the name of an analyte opens the performance window for this analyte with the same date interval as the Quality diagnostic window refer to section 6 1 36 8 The menu Print can print the quality diagnostic of the current section or of all the sections 9 3 Global EQA report Cumulative EQA data are most useful if you wish to access them date by dates diu CO Olympus EQA across analytes Style Print Exit Group Nodes f L 2 Months All Date from 01 05 2004 section 2700 Serum eave v E Zmonthsback w months back Date to 15 07 2004 v Acide unique ALP 11 05 2004 11 00 00 30 9 407 421 0 03 06 2004 11 00 00 30 711 126 127 4 10 06 2004 11 00 00 3043 433 440 0 itll ake Expand nodes 1
54. d in Backup flashing reminder after day s EW 4 Keep only the 3 latest backups and erase the oldest ones 3 A flashing reminder is displayed in the status bar of the charts window when a fixed number of days has elapsed since the previous backup The default value is 7 days DA intemal targets univariate 4 To prevent the backup folder from always increasing its size it is recommended to activate an automatic purging which erases the oldest backed up files keeping only the three latest ones This purging occurs every time a new backup has been successfully completed To backup your QC data open the Backup dialog by clicking on the backup reminder of the status bar or on the main menu Maintenance gt Backup ut AU 640 Backup data 1 Reminder of the previous Latest backup backup date time and folder Date 10 10 2003 23 04 44 2 Reminder of the folder pre Folder C Program Files MultC3 Divers QC 031 01 0 2304444 defined for the present backup Backup folder 3 Start the backup C Program Files MultiQC3 Divers lt To change the folder go to the menu Maintenance gt Configuration gt Backup 10 7 Restoring Most often restoring 1s requested because one analyte has been erased or corrupted by mistake During the learning period of MultiQC a good practice is to backup before any maintenance action to be able to reverse to the initial state if necessary If you want to selectively restore one or s
55. dation dialog e Entered in an IQC profile but not subsequently validated e Received from a serial port thanks to a specialized QC Receiver Interface program e retrieved from the clipboard when clicking on the menu Data entry gt Paste e Retrieved from an appropriately formatted text file when clicking on the menu Data entry gt File e Retrieved from any text file using a specialized plug in e Created by the menu Data entry Fake The panel Pending data in the status bar of the main window blinks yellow red as soon as one QC vector has been enqueued Click on the blinking pane or on the menu Data entry Pending shortcut F4 to show the table of pending QC vectors Coloured deviation icons are the same as for individual validation refer to section 4 1 4 2 and 4 3 for significance The background colour of a row is red whenever the relevant QC vector is globally out of control as CO Olympus Pending data sie Validate Delete Sort Export Exit Section Test Date Time 2r O0 Serumi Bili tot U2 0F 2004 05 1337 27 Serum Acide unique O20 2004 05 14 18 7 00 Serurn Cr atinine O2 0F 72004 05 14 18 2700 Serm Sodium 02 07 2004 05 13 VF A O0 Serum Potassium 2 07 2004 05 13 37 The main menu 1 and the local menu 2 that pops up with a right click of the mouse inside the window give access to the following functions OC 1 68 830 3 1132 23 Oc Oc 3 Jb 294 663 555
56. de of the distribution the side for which the larger proportions nonconforming will result According to the side lower of upper we Soi SD can calculate Cpi or Cpu 1 3 LTL mean UTL Target 7 5 Low sided capability index m 655 E lt Looking at the left picture above the phosphate test has a capability greater than one the yellow double arrow is longer than the ligth blue double arrow The phosphate test would be able to fit to medical needs but this is only a potential capability The actual analytical process is biased The mean is not centered on the target so that nonconforming results will be issued Cp is less than right picture A part of test results is out of tolerance Importance of performance indexes Performance indexes must be considered 1 4 To pick an appropriate QC method A capability higher than 2 six sigma process justifies a light QC Conversely the lower the capability the lower are the acceptable errors and the more careful must be the QC Whenever facing an out of control situation to decide if an immediate corrective action is needed or if this action may be postponed because the analytical process remains acceptable A high capability method can work off centre without any compensation A low capability process must be driven much more cautiously and compensated as soon as a deviation occurs To evaluate the quality of analytical methods in order to forecast if they w
57. declared in the list of operators Logins are created by supervisors with a provisional user name and without password Later the users will have to update their logins themselves to keep their passwords secret from the supervisors l Enter a new operator s name 2 Check one of the boxes Basic operator or Supervisor 3 Validate the new operator with the button Create The new login is then inserted in the left list box and sorted in alphabetic order 50 The new user name is not yet password protected On the first logon a reminder will ask each operator to protect UE EE Sarco his user name by a password jen Uperatar 4 To edit an operator click on his her name in the list ETE change the name the rights and do not forget to validate ian the Update cane otherwise the modifications are nelle paul m l not saved Phil Tom H Basic operator If all of the supervisors have lost their passwords erase the sub folder QCusers in the installation folder of 2 HA Supervisor MultiQC This will reset the list of operators to the unique default operator Noname 12 3 Customization of logins by users Each user is compelled to enter a password when he logs in for the first time MultiQC login Pamela your login is not password protected Click on the button Change to enter a Pow When logging in again later each user will be able to change his user name and his password without referring to a sup
58. e re utigua Multiqual 1 25 09 Multiqual 2 a7 5g 12 After selecting an analyte in the tree view click on the main menu Maintenance gt Control parameters to open the dialog Control parameters l Press the button Ref pool of the Control parameters dialog in the foreground This changes the response of MultiQC when left clicking with the mouse on a QC point of the background charts Instead of opening the table of QC vectors the click now creates a reference pool 2 Create a reference pool by clicking on two different QC points or dates The QC points and dates inside the newly created interval are then displayed light blue Clicking again on another QC point outside inside the reference pool enlarges narrows the interval To be taken into account the reference pool must be large enough to get valid SD s for every control material In multivariate mode an estimate of the me covariance matrix must also be calculated With N control levels this needs at least N 1 complete and independent QC vectors If the calculation of control limits fails the background of dates is made of light blue crosses ak m n i a ae See 3 The first and last dates of the reference pool are confirmed in the foreground window 4 The estimated statistical parameters can be read at the right side of each Shewhart s chart or in the grid of the Control parameters dialog 5 The whole table of estimated parameters and control limits ca
59. e animated graphical tutorial available at www multigc com The Hotelling s T tests whether a QC vector belongs to a control ellipse which is not the same as whether each individual control material is in control There might also be a discrepancy in the ARLs If you are working with 6 control levels and set each one to an ARL of 370 the mean frequency of false alarms will be 1 370 for each control chart For the whole collection of 6 charts the mean frequency of false alarms may vary between e 6 370 if the alarms never simultaneously occur across several levels not correlated e 1 370 if the alarms always simultaneously occur across the 6 levels perfect correlation The ARL of the Hotelling s chart does not depend on the correlations between control levels By default it is set to 200 T1
60. e events bar at the bottom of the charts Reagentlot F Gf Linearity F7 All events F Or thanks to the menu events of the main window of MultiQC 15 6 Editing linearity reports e Click on the tab History and select the item to edit in the drop down pick list e Click on the button Edit which is enabled only if you logged on as supervisor or 1f there are no supervisor e Now you can change anything in the entry fields or to move the calibration marks with the mouse 62 e The button Apply recalculates the new response curve and the new tolerance strip e Do not forget to press the button Save when everything is OK in the edited response curve 15 7 Main menu gt Tolerance The item Tolerance of the main menu opens the tolerance dialog of MultiQC see section 6 1 e If entering a new reportable range verification the dialog shows the current tolerance of the analyte e If consulting the history of the reportable range verification the dialog shows the tolerance at the time when the data was entered which may be different form the current tolerance In entering New or editing mode the tolerance of the analyte can be changed only if you are a supervisor gt Print You can get a printed report of the reportable range verification through the menu Print A preview is displayed before printing 4 Print preview l Start printing 2 Printer setup Reportable range 2700 Serum Acide urige 3
61. ed later a QC point may be drawn between the new control limits but may stay flagged out of control in the table of data Deviation icons are not displayed for QC data collected in versions of MultiQC older than 4 3 0 0 2 From the table of QC values it is possible to export QC data to the clipboard to Microsoft Excel if installed on the computer or to a file 8 3 Table of EQA reports There are 3 ways to open the table of EQA reports e For any EQA target flag on the charts move the mouse cursor over the point until it is highlighted in yellow with a visible popup hint and then left click on it e Left click on the main menu Current analyte gt Table of EQA Shortcut Ctrl F3 e Right click on a chart to open the popup menu and select Table of EQA This table works like the table of QC vectors It is synchronized with the EQA target flags on the background charts ats AU 640 Table of EQA reports Style Edit Print Exit oe ie B e ree eae e Ta eor Da 200a 02 10 07 RIQAS 2671 O04 72005 DAAA RIQAS 287 2 O04 72005 024r RIQAS 2073 1970472003 02 47 41 RIDAS 2o 4 eafU4 2005 11 00 00 RIQAS 2675 26 04 2003 09 00 00 RIQAS 28 6 0605 2003 10 00 00 RIQAS 207r 1370572003 11 00 00 RIQAS 28 9 15057 2003 11 00 00 RIQAS 2070 3070572003 11 00 00 RIQAS 28 10 03062003 11 00 00 RIQAS 28711 a 66 66 6 JE JE The character in the columns Bias or Specif means that the figures are relative figures When a unit name or nothin
62. eels 56 14 4 Automatically duplicating EQA results in Analytes and Analytes ccccccccceeseeeeeeeeeeeeeeeeeeeeaaeeeeeas 57 14 5 Cloning analytes one by ONE ccc ccccceeccccceeeeecceeeceecaeeeeeeeeueceseaeeeesaueeeessaaseeeseaeeeesseeeessesseesseueesssaeeeeesas 57 14 6 Switching to a new batch of control material cee cccceecceeceeeeeeeeeeeeeeeeeeeeeeeeeeeeaeeeeesseseessaeeeeeneeeeeeas 57 15 Verifying the reportable range siccin ai aaa ae 58 15 1 Response curve and tolerance AF ea ccccccccccsccceececeecceeeesueeccueecsucesseecaueesaueecueessaeessueesaueeseeesanenseas 58 152s Repornable range snr E E eeened aut ndee aie eee ea eaaad 59 15 3 Determining the shape of the actual response curve cccceeccceeececeeececeeeeceeceseeeceseucesseeeesaeeeeseeetenes 59 2 15 4 Relating assayed concentrations to true concentrations ee eee eeccceeceeeeeceeeeceeeeseeeeaeeesseeeseueseeeesaees 60 15 5 Storing reportable range verifications cccccccccecseeceeeeeeeeeeceeeeeeeseeeeeseeeeeeeseeeeeeseeeeeessenseeeseeeeesaeeeeeas 62 156 ECLIEIVG WINNS ea y O IRS 5s teaser tcsccten ncicarnsaont cetacean eee tat coterie a E a eahtaiinanae oat entames 62 tT Main MENU ees ec feet ae i ee es ee i ee a et 63 15 8 Tolerance for non linearity error cece ccccceeeceeceeeeecseeeeeeaeeeeeeeeeeeeeeeeeeseeeeeeseeeeeesseeeeesseeseessneeeesaeeeeeeas 63 15 9 Preparation of samples with equally spaced
63. eeseeeseeeeseeeeseesseeeseueeseeeeseeesseeesaeeegs 20 4 3 A ANA OM TE aS sate acco atic aes geese O 21 4 4 Validating a set of QC vectors from the pending queue ccccceeccceeeeeeeeeeeeeeeeeeeeeeeseeseeesaeeeeesaeeeeesaaes 22 4 5 Montonng Me VIN ciate escrmst cris cafues rast oo tamnnsegummpadclea taaashed T datiainadue eatizadae kauguatseumpasana aG 23 5 Analy cal events pecs atic ere ree aneweoes ce E E 24 5 1 Events logged Dy MAU OG oc cccettsencn seceijeieccicascircs E 24 0 2 TRG ONT ON ce eit sorte etc n ference EEE etree coe nib corsa tose TE EAT ee nee cette O E Ea 24 93 The remarks WINGOW ce stesso clo cate a e aT E a aia anaia 24 5 4 The calibrations WINKOW cccccccceeccceeeceeceseeeeeeeeeeeeeceeeeseeeeseeeeeeeeseeeeseueeaeeesaeeeseesseeseueeseeeesaeeeseeesaes 25 ome CUS even WOW Sess sree Sa castcantc nena sanenuse E eE 26 5 6 The cumulated Svents WINDOW sec sssdec sess sndacdedsterenedsuscodedsconsuesauss E ET EE 26 SNA Keeping latest events when archiving and cloning analytes ccceeccceeeeeeeeeeeeeeeeeaeeesaeeeesaeeeseeeeesees 26 6 Assessment of analytical performances cccccceeeeeeeeeeeeeeeeeeeeeeeeneeeaneseaeeeeaeeeeeeneseanessaeeeseegs 27 6 1 Toler ranC ES eee me ene R E N 27 6 2 The performance WINKOW cccccccsecccsesceceeeeeceeeeceueeesegeesseueessaueesaecessaeeessaeeeseasesseeessaeeessaeeeeseneeesanees 27 ls Defnnilion OF ANNAN CCS essiri a a aaiae 29 7 1 Creating AN ANANY
64. ermanently displayed in the Potassium Visible QC points status bar at the bottom of the Prot ines 2 P j l f Public main window o m F Private Ajim E ETM H Muitivariate foating params EJ Program registered to 11 2 Statistical QC with floating parameters Shewhart s control charts are built with two statistical parameters mean and SD Hotelling s charts involve in addition the covariances between QC levels When starting a new batch of control materials these statistical parameters are most often unknown and cannot be estimated as long as a reliable reference pool has not been collected MultiQC however immediately starts charting with provisional floating parameters The two first QC points are charted on an arbitrary ordinate scale When entering the third QC point an estimate of SD can be calculated from the two first ones and QC may start Of course at this stage alarms must not be taken too seriously but graphical display is immediately available The beginning of the Hotelling s chart comes later because the variance covariance matrix needs at least N 1 independent QC vectors to be estimated N is the number of control levels Whenever the operator validates a new control vector he she accepts it as consistent with the previous ones Hence it is justified to include the new vector in the available provisional reference pool and to re calculate new averages and SD s with an additional degree of freedom Esti
65. ervisor MultiQC Change login Old login Pamela Famela please enter your password Mew login E Password 5 O n dt ince 51 13 General configuration 13 1 Configuration dialog Click on the menu Maintenance gt Configuration to open the dialog Configuration gt Tab General 1 Check the box to disable the initial aie MultiQc Configuration splash PELAGI that is disp layed when Analyzers Retrieve data trom other versions launching MultiQC General Events QE comments EGA comments 2 Check the box to prevent data entry without logging on 4 _ Hide splash screen 3 Wh kine twork of 2 No anonymous entry en WOrking 1n a NeCTWwOrk o 4 ll _ computers two PCs cannot simultaneously EZ geese noa access to the same analyte Analytes files are not shared To prevent a user from being able to lock an analyte for too long eee 10 multiQC automatically returns to an idle a status 1f a mouse movement or key press QC data received from other applications eee during a user definable period By Max time interval between assays of default this period is 15 minutes Moreover control materials for them to be lumped in minutes Lab name The Great Laboratory 50 if a technician leaves his or her login open the same GIL vector it 1s automatically reset to Noname after 6 Automation server ON restart Multi after ticking this same period that can be adjusted 4 Header that is printed o
66. es that have not yet been described in the dialog Maintenance gt Analytes These analytes are then created by default and need to be later updated decimal places control mode units control materials 17 4 Exporting QC data Open the table of QC vectors as indicated in section 8 2 da AU 2700 Table of QC vectors E Export Edit Print Exit Copy to dipboard serum Lactate l Click on the menu Export to drop down 2 iiaa the Export submenu Save to XLS 1970572002 1 045 1 2070972002 10 45 45 2070972002 1524 15 2 Four options are available e Copy to the clipboard e Directly open Excel if installed on the computer and copy data to a spreadsheet e Save to an XLS Excel file e Save to a text file 18 On line acquisition of QC data 18 1 QC receiver interfaces QC receiver interfaces are independent programs to be installed on the same computer as MultiQC They are intended to e Receive analytical data from a clinical chemistry analyzer through a serial connection e Extract control assays from the received data e Re send QC data to MultiQC MultiQC works as a controller It receives data from and sends commands to the QC receiver interfaces A single controller may be connected to several analyzers in the laboratory to manage QC data from different sources by the same software application Refer to www multiqc com for further details 18 2 QC file link interfaces QC file link interfaces are designed to
67. established searching for the segment s of the regression line which is are interior to the tolerance area 68 Field method mmol L O v No Ref method mmol L S Scatter plot Comparison of two serum sodium methods Background enlarged below MultiQC searches for the intersections of the regression line with the top and bottom edges of the tolerance area to find out the ends of all the in tolerance segments Then the software projects these segments onto the abscissa axis The commutability range is outlined by a green background on the X axis The methods under comparison are commutable if the commutability range is wider than the reportable range of the reference method Equality line Regression line Field method mmol L Tolerance polygon Point where the regression line crosses the edge of the tolerance polygon Maximum non equivalence error 1 7 mmol l Non equivalence error budget 33 Maximum non equivalence error 1 0 mmol l Allowed regression error lt 130 mmol l 1 7 mmol l 130 to 150 mmol l 1 0 mmol l S amp S gt 150 mmol l 1 7 mmol l l l Ref method mmol L l I Commutability range i Enlarged background of the above scatter plot Comparison of two serum sodium methods Concentrations 7 70 72 16 5 Is there a best regression method for a scatter plot Practice shows that quality of data matters much more than statistical mode
68. everal current analytes use the main menu Maintenance Restore 42 1 The latest backup folder and the date of this backup is displayed 2 You may browse to any other backup folder to reach a previous backup It is also possible to browse to the installation folder of MultiQC on another computer to copy any analyte from the distant computer to the local computer 3 The backed up analytes are shown in a tree view Select either a single analyte or a complete section 4 Start restoring with the button Restore or by double clicking on the item section or analyte to restore It may be rarely disk crash necessary to perform a ais Restore an analyte or a section Backup to be restored os Date Time 18 02 2005 10 19 57 Folder E Backup OlemnpussQ0C 05021 6 107 957 Browse to another backup folder 0 C yymmdd hhmmss Section or analyte to restore B 2700 Serum Acide unique ALP Amylase Bicarbonate Bili dir Bili tot Calcium Chlorure Chol HOL Chol LOL Cholest rol Ck CRE Restore selected tem complete restoring current data archived data configuration data 5 MultiQC stores working files in three sub folders of the installation folder e MultiQC4 QCdata current data and configuration data e MultiQC4 QCarchi archived data e MultiQC4 QCusers users settings 6 Every backup creates a folder QC yymmdd hhmmss where yymmdd is the date of the backup and hhmmss is the time of the backup
69. f this version has not been installed in the 2 default folder browse to the actual installation folder Number of retrieved files 3 Start retrieval The current and archived QC Ey Curent analytes 0 files are read from the old version converted to Archived analytes D the new format and copied to the present installation directory Warning If you use this retrieval twice you will duplicate the retrieved analytes 13 2 Customizing display and printout Every operator may keep his custom settings When he logs on MultiQC shows the analyte that was displayed on the previous logging off with the relevant settings gt Style of charts The dialog to change the aspect of charts is 3 Background QC points Mode code opened with the main menu Maintenance Charts style or the same O Smal Big E command in the local menu that opens when E 5 Mahlon right clicking anywhere on a chart si l Enter 0 in the field One vertical every if you E E Known params want to hide the vertical lines Color scale EI 2 The tree view to select the displayed analyte Ringe Selected Te can be set on the right or on the left hand of the oot Lasers gA charts When charts are completely filled with QC points the new points are added on the right a Ewha bars C of the screen and it may be more practical to One vertical every In contral In contral E show the tree view beside the most recent QC QC point Dut of c
70. g is displayed the figures are absolute figures The unit name is never displayed e g for the hematocrit ratio to prevent any mix up with relative data 33 8 4 Table of events Refer to section 5 6 8 5 Printing tables i Print preview MultiQC can print all of its tables and the 2 Mo gt bt whole page 72 QC charts A preview always comes before printing l Start printing 2 Printer setup 3 Previous next and first last pages 4 Change the scale of the preview josranon reorm seo eso sa T 5 Customize printouts oreson ossa sso fes mol emanon naza sol Ta fool YT 34 9 Tables across analytes The main menu Across analytes allows displaying printing and exporting cumulative tables across analytes 9 1 Daily QC list This list is useful for the QC supervisor who can easily consult a daily summary of all the QC assays performed on a given day in each section of the laboratory It is also a frequent practice to print a paper archive of each day s QC data l The displayed section may be changed through a drop down list 2 The current date is selected when the window is opened It may be changed to any other day 3 Click on the button Apply to activate any change of date which is thus taken into account in the list and in the status bar at the bottom of the window 4 Jump to the day after of to the day before with the arrow buttons 5 Two radio buttons are provided
71. ill meet the medical tolerance interval and to decide if they need to be improved or changed A global quality diagnostic of the laboratory may be displayed for that purpose see section 9 2 QC vectors and multivariate QC Clinical laboratories usually monitor their analyzers with control materials of typically low medium and high concentrations The common practice is to maintain a separate univariate chart for each control level as if multi level QC were only a collection of univariate QCs Even if the three levels of control materials are not simultaneously assayed analyzers are sequential the three assays are always very close in time compared to the length of an analytical run Hence they are affected by the same external factors of variation The three concentrations are not independently fluctuating This creates synchronized fluctuations which result in a correlation between control levels 6 So multi level QC should be analyzed by multivariate statistical methods which take into account both values and correlations between values MultiQC uses the most common multivariate method the Hotelling s T7 Considering height and weight of men provides an easy way to understand why multivariate management is necessary for correlated measurements A normal weight for a man is say between 60 kg and 85 kg Likewise a normal height is between 1 60 m and 1 90 m Thus a 1 60 m tall man weighting 85 kg should be normal from
72. ing difficult reading of the plots e The bias is rarely constant over the whole reportable range Most often differences of calibration create a proportional bias that depends on concentration So the average bias has no practical meaning e Allowed error schemes are more complex in clinical chemistry than the simple agreement limits of Bland and Altman gt Correlation coefficient Correlation coefficient use is inappropriate for comparing analytical methods e The correlation coefficient measures the strength of the relation between two variables not the agreement between them Two analytical methods may be highly correlated whereas a huge bias makes them completely incompatible 70 e The magnitude of the correlation coefficient is affected by the range of concentrations studied The correlation coefficient can be made smaller by measuring samples that are similar to each other and larger by measuring samples that are very different from each other Correlation coefficient has no place in method comparisons because it does not answer the actual question of agreement and has an arbitrary value depending on the choice of analytical samples Correlation coefficient is therefore not displayed by MultiQC 71 17 Importing exporting data 17 1 Importing from Excel gt Formatting the columns of the spreadsheet You can easily import data from Excel by copy paste The QC vectors to be imported must be arranged in the columns of the
73. ique field to enter a common value OC time 11 24 21 2 4 The date and time of the first QC vector J Est Clear entry field 5 The target values of each control l J SREE AUSE material Z First date 01 11 2005 v 6 When validating with OK the fake data are queued in the pending list of data for future validation of QC vectors 18 4 Validating IQC vectors 4 1 Univariate validation Calcium Unit mg L Operator Moname QC levels Result ultiqual 4 Jultiqual 2 Jultiqual 3 9 T Multiqual 1 amp L 39451 a reece tgt 59 50 C 08 ultiqual 2 J nd Ae tge 104 00 Faea Ee ae s KI FAS Multiqual 3 393453 gy t 134 00 Pi 06 The QC vector to be validated is displayed in the validation grid and simultaneously you will see the charts of the background window updated with the provisional points waiting for validation These new points are displayed bigger and collared green yellow or red l Icons in the column Ctrl denote the deviations around the target Inside 1 3 of the control interval Inside 2 3 of the control interval 4p lt gt Inside the control interval Outside the control interval 2 You can revise the comment if needed 3 To erase one QC level tick the relevant box in the column Sup of the validation grid The button in the row of headers ticks unticks the whole column 4 If you tick a box in the column Rej
74. irectly plotted on a Shewhart s chart On the other hand the percent error returned by EQA centres is easy to chart MultiQC draws target flags on Shewhart s charts at the ordinate that the EWMA red line should cross if the method were not biased when compared to the peer group On a graphical item QC point EQA target flag E symbol 16 12 2002 16 03 40 1 26 Peers 0 824 g L Lab bias 2 9 Given the following EQA report target flag highlighted on the picture and with a purple hint e Laboratory assay 0 80 g L e Mean of the peer group 0 824 g L If we briefly do not take into account the uncertainty of the EQA assay the relative bias of the laboratory can be estimated at 2 9 on the day when the EQA assay was made This is a retrospective diagnostic It means that patients and internal QC results should have been 2 9 higher on that day The calibration of the analytical process was adjusted too low 12 An important property of the EWMA is that it is a forecast of where the process will be at the next time period Therefore the EQA target flag is drawn 2 9 higher than the latest known EWMA that estimates the mean output of the analytical process when the EQA assay was made The colour of the EQA target flag is green yellow or red according to the rating set out in section 3 3 The series of target flags are never aligned on a common theoretical horizontal target line because every EQA assay 1s affected by the s
75. ive evaluation of the trueness of an assay The delay between the assay and the return of the report may range from a few days to several weeks Before deciding a corrective action in today s analytical method on the basis of a passed EQA report it is necessary to refer to the internal QC on the day of the EQA assay Therefore both of them are displayed on the same graphs within MultiQC allowing thereby a complete follow up of precision and trueness of analytical methods on a unique screen 1 7 LTA STC charts When tolerance is tight it is essential to achieve stability of an analytical process to keep the method in control When tolerance 1s wider a process may perform out of control and produce however acceptable results Relaxing the level of surveillance provided by the standard Shewhart s chart saves time and cuts costs The LTA STC chart long term acceptance short term control accepts slow drifts of the mean as long as the number of nonconforming assays outside the tolerance limits remains insignificant On the other hand the LTA STC chart monitors short term variability in the same way as a conventional Shewhart s chart but permanently updated with the current moving average Cardiac 543 9930543 tgt 29 500 CYet 6 5 4 gt STC short term control A restated control interval is built whenever a QC point is to be validated This interval is calculated on the basis of the latest mean estimated by the EWMA and of three
76. king on this in the events bar pops up a menu to choose which event window must be opened 5 3 The remarks window The remarks window logs the events Remarks A remark is a short text of 50 characters It reports something that happened in the analytical method and which might affect all of the following QC points Remarks must not be confounded with comments appended to QC vectors The latter only concern one QC vector at a given time The remarks window is opened by clicking on the menu Events gt Remarks or on an icon f in the events bar 24 gt Entering a new remark T MultiQ C Remarks Select the tab New remark enter the text of r the remark and validate with save Y 640 Serum Albumine History Mew remark Check one of the two boxes Add the remark to 1f the same remark must be added to Date Time several analytes for instance when 08 10 2005 11 16 56 changing the lamp of a photometer which Remark 50 characters ee OOS After p ree ne the button Save the remark Add the remark to all analytes of section 640 5 erum is inserted in the history of remarks and its icon is visible in the events bar of the main window Add the remark to anaytes in all sections When scanning several analytes to add a remark MultiQC can meet a busy analyte 1 e an analyte currently processed by another workstation of the network In such a case adding the event is postponed and enqueued to be
77. l items available in the Pending main menu Data entry They will allow an easy loading of QC data with a File simple mouse click The name of the file to be repeatedly imported must be pre set in the configuration dialog Open the configuration dialog by clicking on the menu Maintenance Configuration gt Analyzers 4 The data source must be visible in the centre panel showing that the plug in is operative 5 Browse to the QC data file to be imported to pre select it for future daily work 6 If the name of the data file is variable you can add wild cards to the name 7 Do not forget to press the button Apply General Events QC comments EGA comments Backup Analyzers Retrieve data trom v3 Paste Fake Modular data Roche E170 QC data may be automatically imported from test fles issued by analyzers or LIS A plugin is needed for each analyzer to r arange data For each analyzer you must pre detine the location of the relevant test file AU 2700 4 Centaur 1 Select one analyzer Pand 2 Browse to the file to be imported 5 3 Introduce wild cards it necessary matches anything matches any single character ANOffline dal 5 4 Validate when OK Erase imported files after importation is completed 73 i When importing for the first time through a plug in MultiQC may receive QC data for new analyt
78. lity in a laboratory It may be an absolute or a relative allowed error Most often in clinical chemistry both are associated so that absolute error applies to lower concentrations and relative error applies to higher concentrations MultiQC maintains a table of medical tolerance intervals for every analyte that it controls The software allows sophisticated tolerance schemes because it is possible to separately define relative and or absolute errors for low mid and high concentrations gt Difference plot For every concentration on the X axis the error allowed for the difference within each split sample is represented by a vertical segment centered by the horizontal line of nil bias On the whole individual tolerance segments are merged into a polygonal area framing the nil bias line The top and bottom edges of this polygon are parallel for an absolute tolerance The edges are diverging rightwards for a relative tolerance Interpretation of a difference plot is easy any point inside the tolerance polygon satisfies the tolerance conditions Any point outside of the tolerance polygon denotes the non commutability of the two analytical methods for the relevant sample The final verdict is based on the percentage of non commutable points found on the whole plot 67 Field Ref mmol L 6 0 5 0 4 0 3 0 2 0 7710 72 730 740 D N Mean mmol L Tolerance polygon Regression of differences against means
79. ls Anyone may make his own opinion with MultiQC which can instantaneously switch between ordinary linear regression Deming regression weighted Deming regression and Passing Bablok non parametric regression 16 6 Discrepancies between scatter plot and difference plot The figures below show a comparison between two serum calcium reagents cresol phtaleine versus arsenazo Plots are based on a medical tolerance of 4 and a non equivalence error budget of 33 The scatter plot left picture shows a commutable range of 74 to 120 mg l So the two methods should be directly commutable at least for normal and elevated calcemias The commutable range might be widened to lower concentrations by setting calibration correction factors easy to calculate from the regression parameters There are however 5 out of tolerance pairs in the difference plot blue in the right picture This bad agreement between methods cannot be explained by the imprecison of the one or the other Capability indexes calculated by MultiQC are about 2 for each method Both are therefore highly capable to individually meet the medical tolerance Why then do the differences between methods do not meet the medical tolerance The answer is generally referred to as aberrant sample bias whose origins may be differences in specificity matrix effects or many other unknown causes 69 Dm 12 O Ee 5 x _ a D O ad 110 s 3 amp TE ta O 5 100 2 o p O
80. lytes and across the QC plots without wasting time entering a user name and a password Anonymous entry and validation of QC data can be forbidden by checking the box lt No anonymous entry gt of the configuration dialog refer to section 13 1 This box is unchecked after the installation of MultiQC and may be left unchecked during the trial period of the program Later in routine laboratory use anonymous entries should be forbidden to comply with traceability regulations as MultiQc Data entry Events Across analytes Maintenance Screen MultiQC login EY Phil please enter your password Cr atinine Fer GGT Glucose To log in you must drop down the list box in the top left corner of the main window and click on your user name Your password will be requested except if you log in under Noname There are two kinds of operators amp Basic operators who can enter data but who are not allowed to edit data or to configure the program jae Supervisors who can enter data edit data and configure MultiQC As long as no supervisor has been declared all of the functions of MultiQC are accessible to anyone As soon as there is one supervisor the configuration and edition tasks of multiQC are accessible to supervisor logins only 12 2 Creating logins Click on the menu Maintenance gt Operators to open the operators dialog This menu is accessible only if you are a supervisor or if no supervisor has not yet been
81. mated according to the current control mode Fill mmol L a 1 0 in the grid navigating from cell to cell with the Arrow 75 00 buttons s10 EY os 4 In multivariate QC it is necessary to enter the coefficients of Multiqual 3 114 40 0 5 correlation between control levels There are N N 1 2 2 Display C OSD coefficients between N control levels Practice of clinical eens Pieced ree chemistry shows that these coefficients are generally very similar Therefore MultiQC provides a unique field to enter a common value 5 The button Apply updates the background charts with the entered statistical parameters 6 The button Floating p sets the analyte in the default Floating QC mode 7 The button Undo re instates the initial QC mode 8 The whole table of estimated parameters and control limits can be displayed with the button Limits To quit the dialog press the key Esc or click on the button Exit or on the close box of the dialog When the theoretical distribution of QC points is known there is no uncertainty on the means the SD s and the coefficients of correlation Control limits are calculated through the Gauss law for the Shewhart s chart and through the Khi2 law for the Hotelling s chart 11 5 Distinctive feature of the LTA STC chart The LTA STC chart is built with three parameters e The tolerance limits possibly tightened when the lower allowed Cpk is more than 1 e The short term SDgr This parameter ma
82. mates become increasingly precise and control becomes increasingly reliable At the same time the control limits are updated for the ARL of the analyte and the new number of degrees of freedom according to the Student s law see FAQ section 19 The floating parameters mode is selected by default whenever a new analyte is created with a statistical QC method univariate multivariate or LTA STC 46 11 3 Statistical QC with a reference pool It may be risky to keep floating parameters too long It is easy to imagine how a slow drift in the analyzer would gradually shift the mean widen the control ranges and prevent needed alarms It is necessary to lock the computation of limits as soon as a stable reference period has been collected MultiQC allows the selection of any series of consecutive QC vectors as reference historical pool This series may be easily expanded or shifted when the number of QC vectors increases during the first months of use of a new batch of control materials The final aim is to get a reference pool made of at least a hundred of QC vectors during which the analytical process was stable amp Control parameters 40 Serum GPT_ALT GO eee ia Ret pool Knownpaams Ofisettamets 0 FE To define a reference pool click on the extreme end points or dates of the desired interval we From 13 07 2004 To 20672004 QC Maternal Hean UL ce E ftir ESE AN D EA Pee ere ee em TEEN S REE Er FERAE ts ee On E
83. methods in clinical chemistry are often out of control due to assignable causes which cannot be detected identified or removed for practical reasons It is impossible to maintain the process in statistical control Despite our best effort the process may still have a tendency to drift or wander away from the target Statistical process control SPC will foster improvement only if assignable causes can be eliminated The act of process monitoring using control charts assumes that it 1s possible to bring the process into statistical control without continuous process adjustment Many analytical processes are not stationary The result is that the process mean rarely stabilizes for very long This creates a need for process regulation Engineering process control EPC might be used for such a scenario This approach is based on process compensation The disturbance is predicted apart from random error by the EWMA This estimate of the output error allows a re adjustment of the calibration parameters to bring the process back to its set point Abrupt changes in a process still need to be detected and corrected as soon as possible since an EPC scheme will typically have a hard time compensating against them Combining SPC and EPC schemes is therefore recommended 2 Control charts 2 1 Charts window ais MultiOC 2 00 Serum Cr atinine Giles sm Dataenty Events Currentanalyte Daily data Across analytes Maintenance Screen Current GC
84. n all of the forms Can be changed only in registered programs 5 Program name that is displayed in the title bar of each window and in the taskbar of Windows This is useful to recognize several instances of MultiQC running in the same computer 6 Check the box to turn on the automation server of MultiQC Restart the program after ticking the box 7 When MultiQC is working as automation server checkbox 6 ticked QC results are sequentially received from the analyzer For each analyte it is necessary to lump together the different QC levels in a unique QC vector This is made on a time interval basis QC levels for an analyte are associated in the same QC vector if the time interval between the assays is less that the limit entered in the field Max time interval between levels gt Tabs Events QC comments and QC comment 1 arranges QC comment 2 elaine To create pre defined labels that will thus be easy to select in the drop down list boxes of the relevant entry dialogs ee ere gt Tab Analyzers See section 17 3 Delete line Delete all gt Tab Backup See section 10 6 52 gt Tab Retrieve data from other General Events QC comments EGA comments versions Backup Analyzers Retieve data from other versions Data files of MultiQC3 and MultiQC4 free See a nae cannot be read by MultiQC4 They must be re P Version 3 Ae formatted l Select the version to retrieve Installation folder of the version to retrieve 2 I
85. n be displayed with the button Limits 6 You can switch to Floating parameters with the Floating p button 7 You can return to the initial QC mode with the Undo button 47 To quit the dialog press the key Esc or click on the button Exit or on the close box of the dialog Means SD s and covariances are only estimates of the true parameters of the real statistical distribution Control limits are therefore calculated through the Student s law for the Shewhart s chart and through the Fisher Snedecor s law for the Hotelling s chart taking into account the number of degrees of freedom of the estimates 11 4 Statistical QC with known parameters Sometimes the statistical distribution of QC vectors is known a priori The relevant statistical parameters are directly entered into MultiQC without waiting for the collection of a historical reference pool After selecting the analyte in the tree view click the main menu Maintenance gt Control parameters to open the Control parameters dialog l Press the button Known parameters to display the entry grid wt Control parameters Eg 2 You may enter either the CV s or the SD s Tick the relevant yy box If the mean of one level is zero entering a CV value is T 2700 Serum Chlorure forbidden because the CV for this level would be infinite Fef po Known params Offset targets 3 The grid is initialized with the current parameters either OC Material Mean cy known or esti
86. nalytical process Refer to section 11 to learn the three ways to define this natural variation When a new analyte is created the default provisional mode floating parameters is used 29 1 Tick one of the boxes e Statistical univariate To independently maintain the QC charts for each control level Control method In control ARL Statistical OC Univariate Pe te Pe Fini 70 LTa sTC Non statistical OC C Hotelling 4 Shewhart 2 ama 0 e Statistical multivariate To take into account the correlation between control levels through the Hotelling s T 2 Enter the average run lengths ARL that define the risk of false rejection An ARL equal to 370 means that an average of one false rejection should happen every 370 assays when the analytical method is in control This number 370 comes from the ARL of the historical Shewhart chart with 3 SD limits Control method LTA STC charts 7 3 LTA STC Statistical QC l In the LTA STC method you have only to enter the lower capability threshold that triggers a capability exception Univariate Lower allowed capability ratio Multivariate Lastet ER Non statistical OC Min Cok 1 to 2 2 2 The default value is 1 00 but a higher value may provide a useful security margin LTA STC 1s a simplified QC method in which control limits are not set for a given ARL These limits are always set to 3 SDsr around the EWMA Refer to section 11
87. nce limits are directly plotted on the LTA STC chart When one border of the green control band crosses one of the UTL or LTL lines it means that the capability index Cpk becomes smaller than 1 It is possible to increase this threshold to trigger an earlier capability alarm for a higher C value see section 7 3 The use of acceptance charts is not in accordance with contemporary views on continuous quality improvement Improving quality means decreasing variability The acceptance chart checks conformity to tolerance The LTA STC chart is primarily a compliance tool and not a real quality tool 1 8 What about the QC rules Rules for signalling out of control situations were created in industrial QC during the years 1940 1950 WECO rules and were introduced in clinical chemistry in 1981 Nowadays the power of computers makes them over simplistic and obsolete Rules like 22s 41s or 10x Westgard s terminology are equivalent to checking a gross moving average 8 based on 2 4 or 10 QC points The R4 rule is nothing else than checking a gross moving variance estimated on 2 successive QC points Why carrying on with these arbitrary rules when computers can easily calculate a true moving average EWMA and a true moving variance EWMV which largely outperform the outdated rules Rules have disappeared from advanced industrial QC They should also disappear from clinical chemistry QC 1 9 Engineering process control Analytical
88. ng different tolerance values for low mid and high concentrations of the analyte as it is possible in MultiQC For a given tolerance polygon the number of intersection points depends both upon the shape of the response curve and upon its position relative to the axes of the plot The former is linked to the principle of the analytical method The latter is linked to the calibration of the method Our first step will focus only on the shape 15 3 Determining the shape of the actual response curve Obtain 5 or 9 levels of concentration over a range that is a bit wider than the anticipated reportable range and with equally spaced concentrations See below how to make intermediate dilutions of two pools through sequential mixing The exact concentration of each linearity material may be ignored but the dilution ratios between successive samples must be very accurate Run one two or three replicate samples according to the degree of precision that you need for the response curve that is going to be estimated e Open the linearity window by clicking on the main menu Events gt Linearity Shortcut F7 e Select the tab New range verif 1 e Set the number of dilutions to the desired value 2 e Enter the assayed concentrations in the grid 3 e Validate with the button Apply 4 MultiQC searches its library of mathematical functions for the one which best fits the experimental points This function is adopted as the estimated response curve of
89. ng between two or three rounded values The worst case is made of a series of equal points Calculation of control limits becomes impossible because there is no variation left by rounding gt How to re start only one control level and not all of them together When controlling an analytical method within its whole reportable range thanks to several control materials the QC status of the method on a given time is testified by the association of the concentrations of all of the materials gathered into a non dissociable QC vector So it would be a great error to separately archive one QC level alone even if we had to restart only one QC level This would not allow a real traceability of the passed QC The same number of vials is usually ordered for each level of QC material so as to finish the batches simultaneously The cloning archiving system of MultiQC is made for this way of working However errors or broken vials may sometimes require restarting one QC level earlier In this situation you can 1 Clone the analyte Even if this creates several QC plots nothing prevents you from entering QC concentrations in only one chart Thus it is possible to get an estimate the mean of the new material replacing the terminating one 2 When time has come to switch to the new material keeping unchanged the other control levels you must first change the control parameters to Known parameters if this has not been already done previously Menu Maintenance
90. ontrol ut of control points EWMA line 3 Uncheck the box colour scale to restrict the Analte treeview colours of the background to 3 discrete colours ao Left handed mee Thn OThick Right handed inl wat Style of control chart gt Colours of tables Every table has a menu Style 3 that opens a small dialog 4 to adjust the colours of the tables Any change is passed to all the tables Colours of printed forms Every print preview has a special button see section 8 5 that opens a dialog to change the style of the printed forms Any change is passed to all of the printouts 53 13 3 Networking with MultiQC You can have a remote access to MultiQC from any distant computer The installation folder of the program must be declared as shared and network users must have the permission to modify the files The Windows documentation explains how to share sub directories and apply permissions Distant computers may start new instances of the program with full security l Overwriting analyte files is impossible because these files are opened in Share Exclusive mode When a workstation tries to Information display an analyte which is being processed by another one the Seas a g INMAOT OPEN analyte Amylase former one receives a warning message Busy Thus for instance DJ Fie upreswy acfis busy the QC supervisor cannot update the control parameters of an analyte from his office while a technician i
91. ow logs the events Calibration Calibrator lot 10 characters The calibrations window is opened by clicking on the menu O Events gt Calibrations or on an icon in the events bar It looks and works like the remarks window except for two additional fields Comment 50 characters 25 Kind of calibration full calibration or simple reagent blank Calibrator lot This field is enabled only when the box Full calibration is checked By default the lot is the lot entered on the previous full calibration It should have to be rarely changed only when a new calibrator lot is started Other event windows The reagent lots window which is only a specialized remark window see section 5 3 The linearity window is full software inside MultiQC See section 15 The method comparison window is another full software inside MultiQC See section 16 The repeatability window The cumulated events window The main menu Events gt All events opens a window that shows all the events sorted by time of occurrence You can also access the cumulative events window with the local menu which pops up when right clicking inside any QC chart sub menu table of events dis MultiQc Table of all events Style Print Delete Exit h E Demo Analyte Date Time Description of events 0171072005 13 19 08 f Remark 2 0971172005 13 26 57 Fal Linearity checking 09 11 2005 13 26 23 Full calibration 09 11 2005 13 28 40 a Reagent lot
92. own params Offset targets Ail E 6695 O set all Multigual 2 394 l Press the button Offset targets of the from the initial value Offset when this foreground dialog difference is not nil 2 The column Initial shows the mean of the 6 The buttons in the column Reset erase the reference pool or the entered target value in non offset and reset the targets to the initial values statistical QC mode for each control level 3 Forced target values are typed in the column 7 The button Reset all erases the offsets of all Assigned Use the arrow keys or the Tab key to the control levels navigate between the rows 8 You can return to the previous assigned 4 With the button Apply you can immediately targets with the Undo button update the background charts and check if the entered value replace the target line in the centre of the QC points on the charts 9 The whole table of estimated parameters and control limits can be displayed with the button Limits 5 The assigned new target value is displayed on the right hand of each chart with its difference While offsetting the background charts remain active The analyte can be changed the charts can be scrolled and the hints can be opened hovering above the points with the mouse 49 12 Operators and logins 12 1 Logging in It is not necessary to log in for a simple consultation of QC data Anybody can browse anonymously under Noname across the ana
93. r the key Escape Some analytes may have been duplicated because a new lot of control material is about to be started see section 14 2 In this situation each EQA return is also added to the duplicated analyte Analyte provided there is at least an IQC point older than the EQA return It must be remembered that the EQA target flags are positioned on the Shewhart s charts in comparison to the EWMA curve and that there is no EWMA curve without QC point see section 2 4 When scanning the different analytes of the profile to add the EQA returns MultiQC can meet a busy analyte 1 e an analyte currently processed by another workstation of the network In such a case adding the relevant data is postponed and enqueued to be performed later see section 13 3 3 Fake data generator The Data entry gt Fake menu lets you create a set of random multi normal data It is very useful for demos or training in multiQC l Enter the number of QC vectors to ais MultiQC Create fake data create 640 Medic Theophylline 2 The CV of the method 3 The coefficient of correlation between B Number of QC vectors 100 Target values control levels 0 to 0 999 There are PI CV of the method a Multiqual 1 5 N N 1 2 coefficients between N control Multiqual 2 E 15 levels Practice of clinical chemistry shows qj orelation coefficient Multiqual 3 30 that these coefficients are generally very similar Therefore MultiQC provides a un
94. rage is not yet available at the time of the EQA result This is the case when an EQA return is registered before the first QC vector Although nothing is displayed on the charts data are however visible in z a the table of EQA results Likewise 1f the box Nearest level is ticked drawing EQA target flags will be cancelled as long as the mobile averages are not available for all of the control levels 13 3 Keyboard entry of data 3 1 Data entry through the keyboard ZT MultiQC 640 Medic Lithiu MultiQC can store two types of data iene Events Current analyte l Internal quality control IQC vectors 1 Qe vector Fl 2 External quality assessment EQA returns EQA result Select the relevant sub menu in the main menu Data entry or use en the shortcuts F1 and F2 Pending File Paste Fake For a big amount of data it is more appropriate to use a profile Section 3 4 on line acquisition of data section 18 or importation through a file Section 17 3 2 Entering a single QC vector Entry to Analytes ttt AU 640 Serum Lactate tEiekabs A Current analyte Across analytes Maintenang TEETE 5 4 s Editing QC vector P QC vector Fi Ww p T a Event F3 wr elle Operator Noname Unit mg dL EQA result F aU Date 30 08 2003 Time 124250 profile 19 8 Multiqual 1 naa Pen F4 Multiqual 2 sb File 13 4 Paste 19 2 Multiqual 3 GOT 45T fit 16 6 Initialize EW MA and EM HY GPT ALT 6 L LDH 18 4
95. rator Noname 3 Frame EQA rating Date 13 05 2003 Time 055611 e Tolerance This field shows the allowed L Lab value i45 gL error for the concentration found by the peer group see section 6 1 Peer group 1 490 g L EQA rating Tolerance 10 0 4 Error 2 e Error Relative or absolute according to what is applying e U bar This coloured bar graphically displays the bias of the assessed analytical method This bar is calculated in relation to ees o 40 the allowed tolerance An EQA result is OK 3 5 he ca ANY o 6 green spot when the bias is lower than Unda Cancel half the allowed error The result is acceptable yellow spot when its bias is lower than the allowed error Unacceptable EQA results are flagged red When relative tolerances and errors are displayed the sign is appended to the figures When absolute tolerances and errors are displayed the measurement unit 1s appended except when this unit is itself a percentage e g for the hematocrit ratio 4 Use the button Edit to correct a mis entry 5 Click on the button OK if OK A new EQA target flag will be displayed in the shewhart s charts See section 2 4 6 The button Undo is disabled when entering an EQA report It is enabled only when editing 7 To quit press the button Cancel or the key Escape 3 4 Creating entry profiles for QC and EQA data In routine lab work analyzers typically print out QC data level by level
96. red to Ex 9 Control mode of the current analyte 10 Dates of the first and of the last QC vectors 11 When the number of QC vectors is greater than the number of displayed points the scroller is enabled to shift the time axis of the charts QC point The mouse Cursor becomes a hand that horizontally drags the charts as long as the left button is not released You can also scroll the charts by left clicking outside a Two blue triangular butttons are also provided at the ends of the dates to scroll them when possible 12 The events bar is located under the row of dates Refer to section 5 to read more about analytical events Visible QC points Expand Y scale EWA on 11 12 2001 05 09 2003 Public Chart 1 EWMA a EM My mE Private 150 1 00 4 Every chart Nearest level Collapse T 13 Dropdown pick list to set the number of displayed QC points When Public is checked the value of the dropdown pick list applies to all of the analytes If Private is checked only the current analyte is changed 14 Dropdown pick list to expand the range of displayed concentrations along the vertical axis 15 Check the boxes to hide the EWMA line and the EWMV bars or in multivariate QC mode to collapse the T chart to a row ais Bayer Centaur BNP of green red indicators according to the validity status of the relevant QC vector Data entry Currentanalyte Across analytes Maintenance Screen Honame
97. rint Exit vectors select 640 Serum Calcium them in the table and D ate Time OC 1 OC 2 WL 3 Cpk Comment 29706 2004 154517 563 968 1303 151 Click on the 29 06 2004 16 0437 55 6 56 0 1305 6 1 87 menu 30 06 2004 15 42 52 569 999 1341 6 1 71 Edit gt Delete 30 06 2004 16 34 58 566 99 0 13932 173 Or right click 0 06 2004 1213 23 ad ae 1348 Lad aeidetneable SADE Vee ee m wacce a local 0170772004 09 50 06 Edit OC vector popup menu OOF 2004 10 26 43 i die 100 4 adh 135 7 141 aaa E A S OOF 2004 11 01 28 5 999 13394 6 157 ep d ii Eni 091 072004 12 28 50 a 462 db 132 3 1 62 T 01 02004 1515 03 3 amp g979 qe 1320 1 76 i Or press the 0170772004 16 04 31 3 976 1322 1 95 Delete key of E ETT Ts the keyboard To edit a QC vector use the main menu the popup menu or double click on the line containing an erroneous datum Re validation works as indicated above The QC vector to be re validated 1s removed from the charts and inserted in the entry dialog as if it were a new entry 39 10 2 Editing or deleting EQA results or events It is easy to edit or delete a mis entered EQA result or event This requires the access rights of a supervisor It works like editing QC points 10 3 Erasing across analytes It is sometimes necessary to simultaneously erase all of the data entered on a given time to allow an easy correction of mis entries which concern several analytes MultiQC can scan the an
98. rs of the day e Continuous when two mirror analyzers are simultaneously performing the same assays to increase the analytical throughput Method comparison is usually recommended when a new analytical method is started But it is also useful to resort to method comparison in routine work either to troubleshoot an analytical issue or to demonstrate the permanent agreement between two analyzers within a laboratory or between two laboratories 16 2 Criterion of comparison Changing an analytical method to another one is only possible if they agree sufficiently closely In this respect two analytical methods can be equivalent commutable or incompatible e Methods are equivalent if they give equal results within their inherent imprecision They can be interchanged without loss of analytical accuracy e Methods are commutable if they give equal results within the medical tolerance interval They may be not rigorously equivalent but they can be however interchanged without loss of diagnostic power for patients e Incompatible methods lead to results with differences greater than the tolerance interval Taking into account that our laboratories are intended to a clinical use a departure of a new method from the current one can be accepted 1f it does not impair the medical diagnostic or follow up So the best cost effective criterion that allows interchanging two analytical methods is commutability and not equivalence Error made by replacing an
99. s 0 and 2 34 As soon as the two calibration points are set MultiQC updates the plot e It draws the ideal straight response line that crosses the two calibration marks e It draws the tolerance area framing the ideal response line with tolerance intervals e It graduates the X axis with a scale of assigned values replacing the scale of dilutions e It searches for the segment of the actual response curve interior to the tolerance area and project it onto the Y axis to graphically show the reportable range as a green background behind the axe e It displays the numerical value of the reportable range in the bottom status bar of the Linearity window 60 ou cm aT 2 point 2 calibration f 3 00 ei i o 1 75 Reportable range 1 50 Calibration 125 points 1 00 4 0 75 0 50 0 25 vy SD a amp amp amp DS YY S e amp DS a a S amp amp D i OR m oe oy y y we y oo ay oa oo ooy e Assigned mgL gt Moving the calibration marks It is very easy to move the calibration marks to test if a better choice of the calibration concentrations would improve the reportable range e Hover the calibration mark to move with the mouse cursor to enlighten it in yellow e Left click on the enlightened yellow cross It turns red e Keeping the left button of the mouse pressed move the calibration mark along the response curve and drop it where you wish by releasing the mouse button
100. s dialog by clicking on the menu Maintenance gt Analytes e Select one by one each Analyte in the tree view and click on the button xx gt xx 5 in the picture above The mother analyte will be archived and the cloned analyte will take the place of its mother analyte e Before your quality control is ready to run again with the new batch you will have to adjust the control mode define a reference pool or enter known control parameters 57 15 Verifying the reportable range Establishing and verifying the reportable range is an integral part of quality control and cannot be performed without the knowledge of tolerance data which is shared with QC programs Therefore MultiQC includes a linearity module for recurrently monitoring the non linearity error of all the analytes which it controls MultiQC does not use the protocol EP6 A by the CLSI NCCLS What is not appropriate in the EP6 A protocol The EP6 A CLSI protocol is artificial because it is not based on the very definition of the reportable range The error of its editors was to think primarily in terms of linearity instead of terms of allowed error Straight line or not straight line That is not the question The true question is to decide whether the departure of the actual response curve of an analytical method from the ideal straight line is acceptable or not Stepwise polynomial regression is recommended by the EP6 A protocol It is an efficient statistical tool to
101. s validating QC results for this same analyte The supervisor must wait till the analyte is freed to be allowed to access it The self idle function of MultiQC section 13 1 prevents anybody from indefinitely locking an analyte 2 Some actions of MultiQC need an update of all the analytes actions across analytes If one analyte is busy at this time and thereby cannot be accessed the action is postponed to be automatically tried again every 1 minute till OK it can be performed Information 2700 Serum Bicarbonate i Busy analyte s event s enqueued for 2700 Serum Calcium Information i 2 other workstations are presently running MultiQc 3 Some configuration actions cannot be done if Fo ee SS a aE several instances of MultiQC are running A the requested maintenance action warning message 1s displayed siesta ele tes a when MultiQc was not correctly dosed eg power failure In this situation simply dose and restart MultiQc Information 4 Conversely when a workstation is configuring MultiQC other workstations cannot start the ee ee ees eee iy program as long as the configuration task is not wp Please wait a few minutes before launching MultiQC completed MultiQC is designed for a peer to peer architecture in which each workstation has equivalent capabilities and responsibilities QC data are different from patients data The latter data are best managed with a clients ser
102. sects ctens stirs th e e a a e a aa 74 182 OC MIBK IMeH ICO S e r R E Gace eedencceseenecmasetaaeaadanee 74 19 Frequently asked QUESTIONS wccccsaesaeciceenctise eas iscaed Aecvins ie eteeteaeae avant eae oe te ae 75 1 Concepts MultiQC www multigc com is an innovating software application specifically designed for quality control QC in medical laboratories Industrial QC has known great improvements for the last three decades while medical laboratories have not evolved MultiQC is aimed at promoting an updated approach of QC in clinical chemistry 1 1 Long term and short term variability Multiqual Variations of the analytical process charted in the picture above can be measured in terms of e Long term LT variations The double arrow 1 shows the total spread of QC values when all of the points are taken together Long term variations take into account the shift that occurred when the lot of reagent was changed Long term variability is measured by the average of the squared deviations from the target value the centre green line on the picture below e Short term ST variations The double arrow 2 shows the spread of the QC values about the mobile average of the process the red line Short term variability SD R is measured by the mean range of span 2 excluding the points where the EWMA d has been restarted e g the yellow point on the picture above see section 10 5 When the analytical method is stable SDi
103. short term standard deviations see section 1 1 Merging the daily control intervals creates a green band on the QC chart that plots the span of the natural short term variations of the method The point 1 is plotted outside the green band The LTA STC chart will raise an out of control exception As in any Shewhart s chart this means that an assignable cause has changed the process which is not performing in a stable fashion about its current average output the red EWMA line Conversely the point 2 is in control although higher than the point 1 The position of the point 2 is within the green band because of the higher current average output The deviation does not denote a short term instability of the process Control deals with the ability of a process to perform in a consistent stable fashion gt LTA long term acceptance The two straight red lines are the upper and lower tolerance limits UTL and LTL The analytical method meets its tolerance and is hence acceptable as long as the green band does not encroach on the red lines In region 3 a part of the analytical production will fall outside the tolerance limits The LTA STC chart will raise a capability exception because the rate of nonconforming items is too high The long term drift makes the process unacceptable An adjustment is necessary Acceptance deals with the ability of a process to meet its tolerance gt Tolerance limits By default the two raw tolera
104. t SDsr Here the method is not stable SDir gt SDsr because of the drifting and shifting average of the process 1 2 Process capability and process performance indexes The quality of a manufactured product is its uniformity about a target There 1s no unique target in clinical chemistry but a true concentration for each sample So analytical quality is uniformity of assayed concentrations about true concentrations Tolerance limits tell us how much variation can be accepted They are laid down by national regulations or derived from clinical needs from biological variation or from the state of the art gt Capability index The capability C of a method relates the tolerance interval to the inherent analytical variability The capability is equal to the ratio of the width of the tolerance interval C UIL LIL Upper Tolerance Limit Lower Tolerance Limit to the spread of the natural 6x SDo5y variations of the analytical process 6 standard deviations The factor SD of the denominator is the short term SDsr which measures the lowest possible variability of the process when it is permanently in control Briefly C is the ratio of what must be done the allowed tolerance to what the process is able to do the expanded uncertainty of the assay It informs about the inherent capability of the analytical method provided it were operating at a stable average The higher the capability the lower is the risk of jumping the tolerance limi
105. tC cece cceeeccccseeeeeeceeeeecaeeeeeeeeeeeeeeeeeeeeeeeeeeeseeeeeesseaseeeeeeseesseaeeeessageeesseseeesaeeeessaaeeees 29 7 2 Univariate and Multivariate Statistical QC oo cccccccccseeeceeeseeeeeeeeeeeeeeeeeeeseeeeeeeesseaeeeeeeseeeseeessaaeeeeseneaas 29 1 3 CTA US asc ets E ges seein ee pases oa ie annette E A E A A O 30 7 4 NOM SUAS EAE rE ems este E E E EAEE E E E EA E teats eeesaseumeeeee 30 7 9 Editing deleting an analyte or a section ccccccceccccceeeeeeeaeeeeeeaeeeeeaeeeceeeeeeeessaeeeeseaeeeesaaeeessegeseeeaaees 30 7 6 Changing the section of an analyte in the tree view cccccseecccceeeeeeeneeeeeeeeeeeeeeeeeeeeseaeeeesaeeesseeseneas 31 G3 Tables within analytes esrar a othe onal wan duuewsea A aE a 32 8 1 Three tables of data for each analyte ccccccccccssscecceeceecesscecceseeecsaeeecsegeeecsuseeessageeessegeeessaneeeeeeas 32 8 2 AOE OCG VECO S aei a eee a A 32 8 3 Tablecor EQOA TE DOS yssen o a ald a Medios euiise 33 8 4 TADE OrEVENS airau oc oo spaces a sate dae Ge yedesaew asad cog a AE E E E A 34 8 5 PARING TADIC Seea a A E E ancien ee eee rere eer eee ner ee re ere 34 GS Tables across analytes ices niecscewekcecaeecncdecis cages A iene sicencehwadeensucdeatesaeveevawcesnccsess 35 9 1 Daily QC NS ie iesciece terete een ieee ee ee ete ee oa eee ci ee ae ace 35 9 2 Qualy diagnos Cusan tastes eee a A a a a Ade dctas A deta detseadies 36 9 3 Global OPC OU cite tect ceccrs ieee tt rece
106. the analytical method and the relevant curve is drawn At this step we have found a shape but the response curve remains uncompleted because the X axis is yet graduated with the number of the dilutions instead of the true concentrations 59 tt MultiQC Verifying the reportable range Tolerance Print i Demo Demo analyte Histor Mew range werf 4 Date Time E 01 11 2005 W 134 50 E wi Comment 50 characters Dilutions 2 Calibration interval mg L Low end High end Multi points calibration A ae Non inearity error budget 100 k Dilution 15 4 Relating assayed concentrations to true concentrations A faulty calibration might shift the response curve out of the tolerance area and reduce the reportable range But this is another problem We must pull apart non linearity error and inaccuracy supposing that the method was precisely calibrated before assaying the set of samples with equally spaced concentration gt 2 point calibration Let us assume that the instrument is in control and that it was calibrated in 2 points 0 g l and 2 34 g l This means that by definition and ignoring the uncertainty of calibration the actual response curve is true for these two concentrations 0 and 2 34 g l Hence we know two points of the ideal straight response line and consequently can draw it on the plot Move the mouse cursor over the plot and drop two calibration marks blue crosses at the ordinate
107. to sort the table by analyte or by time This sorting goes for both displayed and printed lists as CO Olympus Daily OC Style Print Exit 2 g o QC 2 QC 3 TA Cpk Tec 597 1160 5 1172 595 1160 324 390 dbg 15369 154 340 Sort by Analyte Sort by time Analyte Time WIL 1 Comment 03 1306 327 09 1309 4 333 17 59 22 4h 337 03 1302 223 17 59 20 4 232 ALP 09 13 06 34 Acide urque 2nd bottle Albumine Ammoniaque Amylase Bicarbonate Bilt dir 17 59 22 09 13 30 09 13 06 Teog ae 09 13 02 17 59 20 09 13 02 17 59 20 34 545 37 1 360 11 8 117 2509 249 Oc of 640 Serum on 23 11 2004 154 3093 113 4 1162 d 15 7 db 15 1 1230 1234 340 2622 2626 2258 225 2313 22 56 Heo f Refer to section 1 for the significance of coloured deviation icons The background colour of a row is red whenever the relevant QC vector is globally out of control You can print an individual report for each section of the laboratory by clicking the menu Print gt Displayed sections It is also possible to print a cumulative report for all the sections by clicking the menu Print gt All sections Validity icons are not displayed for QC data collected in versions of MultiQC older than 4 3 0 0 35 9 2 Quality diagnostic A global diagnostic of the analytical quality may be easily put forward for each section of the laboratory
108. tolerance data of other analytes through the button Show table of tolerances 6 2 The performance window For each analyte you can open a performance window either with the main menu Current analyte Performance or with the menu Performance that pops up when right clicking inside any QC chart 2 ais MultiOC Performance of the analytical method 00 Serum Potassium Tolerance Date interval From 18 09 2005 w To 17 11 2005 Fixed interval BOlatestdays Histogram classes s Potassium mmol L From 18 09 2005 to 17 11 2005 The size of the window and the width of the columns can be changed l You can browse through the performances of several analytes with the double arrow button 2 The grid at the top of the window shows the distribution parameters for each control material 3 A detailed histogram may be displayed selecting the tab sheet relevant to the wished control material The performance of an analytical method 1s evaluated with the QC data collected during a given period which may be pre set 4 of defined from any day to any other day 5 gt Diagrams of the span of QC data q The light blue double arrow shows the interval mean 3 SD in which 99 7 of the analytical production is assumed to fall provided the method remains in control The light green background shows the tolerance interval for the relevant level of concentration If the light blue double arrow does not encroach on the red
109. tolerance intervals for each concentration are merged into a polygonal area framing the ideal bisecting line The edges of this area are parallel for an absolute tolerance The edges are diverging for a relative tolerance 15 2 Reportable range A curved response line may partially meet the tolerance of an analytical method provided that the interval of measured concentrations is adequately limited The reportable range 1s the range of concentrations within which the non linearity error is smaller than the tolerance Analytical results inside this range are conforming and can be reported The other ones must be discarded and the sample reprocessed The reportable range of an analytical method is established searching for the segment s of the actual response curve which is are interior to the tolerance area and then projecting 1t them onto the ordinate axis Why not project onto the X axis Because of the practical use of the reportable range Technicians will compare each concentration measured by their instruments to the reportable range to decide whether the assayed values are conforming or not It is the reason why the reportable range must be also expressed in terms of measured concentrations ordinates and not in terms of true concentrations abscissas Practically we have to search for the intersections of the response curve of the method with the top and bottom edges of the tolerance area This area may be a rather complex polygon when setti
110. ts snesena an dw oteeyaweneuaiauunne belowncekenentenyancueenieawnedsaddieccioniebuswennawedd 12 2 4 E OA target ags acep a E E 12 3 Keyboard entry of data nnannannnnnnnannnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnennnnnnnnnnnnnnn nennen annn nnen nnn 14 3 1 Data entry through the keyboard cccccccsescccsssceceseeceececeseceseseeceseeeesaeeeseeceneueeenaneesaseessaeeessegesenaas 14 3 2 Entering a single QC vector ccccccssseccccceseececcceeeeeceeecseseeceeesuauseceeesseaseceesseaeeeessuaueeeeessuaeceeessaaaaaeees 14 3 3 Entering and rating an EOA etry sorserien oeo eE EEA aa EERTE RERE 15 3 4 Creating entry profiles for IQC and EQA data cc ccceccccccscccccesseeeceeeeceeeeecceseeeseageeesseseesssseeeessageees 15 3 0 Typing in QC data through a profile cccccccecccccssscecceeseeceesececceueeeeceageeecseseecseeeessageeecsenseesssageeeesas 16 3 6 Typing in and rating EQA returns through a profile ccccceecececeeeeeceeeeeeeaeeeeeseeeeeeeaaeeessaeeeeesaeeeeenas 17 3 7 Fake data GNIS ON estes anita cia enhance En enoulia noir audnn s an ER E E ERA 18 4 Validating IQC vectors iasacsntcscertaesecrtaawiacaenseis ccecves boesenvedtanneiaieacesomssasus tnsietubwortrsneselaargusaessanentsessexs 19 4 1 NITY AS ANN UA OMe soe ees es sa ects asec eect ieee es ee aap e a E E a E aa EE 19 4 2 Multivariate Validation cccccccccceececeeceeeeeeeeeeeeeeeeeseeeeseeeeseeeeseeeese
111. ts and therefore the higher the quality LTL UTL Target 15 Target 8 Number 0 a _ S 8 amp Ss A Bg Ss FF PO WY fF Amylase U L Bicarbonate HE Histograms of 60 day QC data for amylase and bicarbonate assays Estimated gaussian distribution curve of QC data lt gt Expanded uncertainty of the assay mean 3 SD lt gt Medical tolerance interval y Out of tolerance assays Capability e The capability of the amylase method left picture is about 2 The assay is able to fit to medical needs 15 and should never produce out of tolerance nonconforming results even if the QC mean slightly deviates from the target e The capability of the bicarbonate method right picture is less than 1 The assay cannot fit to medical needs 8 A part of the results does not meet the tolerance They are nonconforming The analytical process must be improved gt Performance index P is calculated with the global variations long term SD r of the process in place of UTI _ LTI the short term SDsr It informs about the actually observed capability of the P _ analytical method when performed in real laboratory practice with possible drifts or shifts of the average gt One sided indexes _ mean LIL A major shortcoming of the Cp and P index is that it may yield erroneous information if the process is not on target that is if it is not centered Cp and Ppk denote the capabilities on one si
112. validity of the QC vector depends on the value of the relative T as compared to 1 An exception is raised when the relative T is greater than 1 T Non significant Hotelling s test Relative lt 1 Operator Noname Unit g L Date 27072002 Ime 1 0000 E T Significant Hotelling s test Relative gt 1 Qc levels Result A discrepancy may sometimes occur between the global Multiqual 1 0 618 validity status of a QC vector according to the Hotelling s lultiqual 2 1 212 test and the individual validity status of each level See the Multiqual 3 3 660 last FAQ in section 19 for possible interpretations alative T 0 93 In the above picture the QC vector 1s globally in control according to the multivariate test relative T lt 1 The third control material is however individually out of control The arrow in the third row should be red Priority is given to multivariate testing The background colour is thus green denoting the global in control situation Orange arrows denote individually out of control QC points that should be red in univariate mode but that are superseded by a globally in control multivariate validity test icon T When the Hotelling s T cannot be calculated because one control level is absent or rejected multivariate QC is validated in univariate mode 20 4 3 Validation in LTA STC charts The global validity of a QC vector results from two simultaneous criteria A 20 29 ais V
113. ver architecture in which one computer 1s dedicated to serving the others because patients data are of general concern for the whole laboratory QC and EQA data are closely related to the analytical instrument they originated from There must be a permanent interaction between analytical processes and the software devoted to control these processes Therefore MultiQC prioritizes the local role of QC For an easy permanent and instantaneous access to charts MultiQC should be installed on the local disk of a computer near the laboratory bench The tree view of analytes must not be too crowded It should only contain the analytes of interest for the operators working at this bench The laboratory manager is a secondary user of MultiQC He she may access and review the data distributed on the computers in his laboratory thanks to a series of shortcuts on his desktop Each one is connected to a distant program file MultiQCS exe 54 14 Control materials 14 1 Control materials Usually each control material is utilized to control several analytes This is the reason why the names and lots of control serums are entered first in a table and then assigned to different analytes Creation and assignment of control material are done from the main menu Maintenance gt Control materials While entering control materials the background charts remain active The analyte can be changed the charts can be scrolled and the hints can be opened hovering a
114. verify linearity but verifying linearity is unimportant in a clinical laboratory What we do need is to establish a reportable range for a given shape of response curve and for the allowed tolerance of the analyte 15 1 Response curve and tolerance area The response curve of an analytical method is a plot of the measured concentration as a function of the true analyte concentration Ideally the measured and the true concentrations should be equal whichever these concentrations might be Thus the ideal response curve is the bisecting line in a plot of measured versus true concentrations Measured concentrations Non 2 Ideal response conforming 7 line j 4 2 M Actual response c curve 1 Non linearity error Tolerance area O Point beyond which non linearity error exceeds tolerance Reportable range True concentrations Absolute Relative tolerance tolerance 58 A significant departure from this perfect agreement is nevertheless acceptable because of the error tolerated for the analyte The vertical distance between the ideal and the actual response curves is named non linearity error It must not exceed the tolerance of the method This tolerance may be expressed as an absolute or as a relative acceptable error Most often in clinical chemistry both are associated so that the absolute error applies to the lower concentrations and the relative error applies to the higher concentrations Graphically the
115. work combined with data processing software or a LIS which is in charge of outputting QC data to temporary shared files stored in an exchange subdirectory File link interfaces are programs which regularly scan this exchange subdirectory When QC files are found they are read Data is transmitted to MultiQC and the temporary files are erased Refer to www multigc com for further details 74 19 Frequently asked questions gt The ARL is set to 370 Why is the control interval somewhat larger than m 3s The historical Shewhart s chart was based on the control interval m 3s where m and s were the mean and the standard deviation estimated from the reference pool of QC points The multiple 3 of the standard deviation was adopted because it resulted in few false rejections for a satisfactory rate of error detections In a Gauss distribution u 0 a random value oversteps the bounds u 30 once every 370 times 370 is the theoretical in control ARL average run length of the Shewhart s chart The actual ARL was also 370 because a reference pool of 400 QC points was advocated With such a big sample m 3s is always very near to u 30 In clinical chemistry we work with much smaller reference pools The interval m 3s estimated from a small sample is generally narrower than u 36 a smaller number of values means a smaller scattering The exact interval associated to the ARL 370 is m ts where t is the Student s t for the probability 0 27
116. wy 107 8 1405 167 407 77 TfCpk Comment H T A TET aiden Automatic validation Delete Sort e Manual validation successively presents all the vectors of the pending queue in the validation dialog see section 4 1 to be individually accepted rejected or deleted e Automatic validation triggers an automatic validation Pending QC vectors are checked one by one and inserted in the relevant analytes if they are in control Out of control vectors remain in the queue and need a manual validation Warning when working in floating parameters mode Manually validating and accepting one by one several QC vectors for the same analyte is not the same as automatically validating them In the former case the control interval is revised after each new accepted result whereas in the latter case the control interval remains unchanged during the whole validation process e Deletion of all the QC vectors of the pending queue or of only the selected vectors e Sorting the list of pending QC vectors either by date time of by analyte name e The main menu Export is aimed at re processing pending QC data through another program The Re ee ona F7 ea E Tre j pending queue is cleared and its data are sent either to Microsoft Excel or to the clipboard After re processing QC data can be retrieved in MultiQC through Copy Paste 22 3 A quicker way to validate a single QC vector is to double click on its row When
117. y be floating estimated from a reference pool or known a priori When SDsr is not known a priori its estimate from a reference pool is not very consistent if the number of QC points is too low Therefore when a LTA STC chart is started MultiQC does not build the chart with the true estimated SDsr as long as the number of QC points is less than 10 The provisional control interval green band 1s Current ELWMA Allowed error e The target value which may be also floating estimated from a reference pool or known a priori 48 11 6 Offsetting the target values Since a control chart compares the current performance of an analytical method to the passed performance of this method changing the control limits frequently would negate any usefulness Sometimes we have a valid compelling reason of doing so when a known act changes the way the method would behave calibration new lot of reagent new slope factor to align the lab results with its peer group An offset may be added to each target value shifting the QC curves upwards or downwards according to the sign of the offset The offset can be easily zeroed if the reason for which it was introduced disappears The targets are thus reset to their initial values After selecting the analyte in the tree view of the main window click the main menu Maintenance gt Control parameters to open the Control parameters dialog as Control parameters 640 Serum Calcium Ref pool kn

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