Using the QC Programs 8-20 doctor. CAUTION Do not re-use disposable products like collection tubes, test tubes, capillary tubes, etc. NOTE Be sure to use the Mindray-specified disposable products including evacuated blood collection tube, centrifugal tubes and capillary tubes etc. If the sample mode is switched from the "Predilute" to "Whole Blood", the analyzer will perform the switching sequence automatically and a progress bar will be displayed on the screen. 1. Prepare the control as instructed by instructions for use of the controls. 2. When it is ready to run a sample (i.e. the status icon and the analyzer indicator is green), shake the vial the control as instructed by the picture below to mix the sample thoroughly. 3. When it is ready to run a sample (i.e. the analysis status icon and analyzer indicator is green), present the whole blood sample to the sample probe. 4. Press the aspirate key to start the analysis. 5. The sample probe will automatically aspirate the sample. When you hear the beep, remove the sample tube. The analyzer automatically analyzes the sample; the analyzer indicator is flickering in green and information in the "Next Sample" information area refreshes automatically.
Using the QC Programs 8-21 6. When the analysis is finished, the status icon and the analyzer indicator will return to green, and the results will be saved into the QC file of the QC sample ID automatically. NOTE Up to 372 QC results can be saved in each QC file. 7. Do the above procedures to continue running QC analysis if necessary. AL-WB All the samples, controls, calibrators, reagents, wastes and areas contacted by them are potentially biohazardous. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them and the contacted areas in the laboratory. WARNING The sample probe is sharp and potentially biohazardous. Exercise caution to avoid contact with the probe when working around it. The sample may spill from the uncapped collection tubes and cause biohazard. Exercise caution to the uncapped collection tubes. Be sure to avoid reversing the collection tube when loading, otherwise, the collection tube may be broken and biohazard may occur. The breaking of collection tubes may cause personal injury and/or biohazard. Exercise caution when loading the collection tubes to the rack or getting the collection tubes from the rack, be sure not to break the tubes. The breaking of collection tubes may cause personal injury and/or biohazard. Exercise caution when loading the collection tubes to the autoloader or getting the collection tubes from the autoloader, be sure not to break the tubes. The pusher will push the rack inside the autoloader. Be sure your hand is away from the rack before starting the autoloader. Keep you clothes, hairs and hands away from the moving parts to avoid injury. The reagents are irritating to eyes, skin and diaphragm. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them in the laboratory. If the reagents accidentally spill on your skin, wash them off with plenty of
Using the QC Programs 8-22 water and if necessary, go see a doctor; if the reagents accidentally spill into your eyes, wash them off with plenty of water and immediately go see a doctor. CAUTION Do not re-use disposable products like collection tubes, test tubes, capillary tubes, etc. NOTE Be sure to use the Mindray-specified disposable products including evacuated blood collection tube, centrifugal tubes and capillary tubes etc. 1. Prepare the control as instructed by instructions for use of the controls. 2. Paste the barcode to the vial of the control (for details about pasting barcodes, see 6.8.4 Barcode Labels). 3. Make sure the QC mode is “AL-WB” and the analysis status icon and analyzer indicator is green. 4. Make sure the barcode labels are well pasted to the containers of the controls. 5. Accommodate the prepared control into the rack. 6. Place racks loading controls on the right tray of the autoloader, with the back of "MINDRAY" mark on the carrier facing the analyzer. 7. Tap the "Start Count" button on the dialog box to start running. 8. When finish running, you can remove the racks from the left of the autoloader. NOTE If nothing is scanned or no matching lot No. is found, the analyzer will jump over the certain control without analyzing, and proceed with barcode scanning and QC analyzing of other controls. 9. After the analysis finishes, the QC results will be saved into the QC file of the QC sample ID automatically.
Using the QC Programs 8-23 NOTE If any control is jumped over without being analyzed, a prompt will pop up when the analysis cycle is completed. Tap the "OK" button to close the prompt. Up to 372 QC results can be saved in each QC file. 10. Do the above procedures to continue running the QC analysis if necessary. 8.2.3 Review L-J QC Results After QC analysis, you can review the QC results in the following ways from the PC: QC Graph QC Table Parameter QC Graph Monthly QC Graph L-J QC graph review 1. Click "QC", and then select "L-J QC" from the "QC Program" pull-down list to enter the L-J QC graph screen.
Using the QC Programs 8-24 NOTE If the PC used to be connected to different analyzers, select the desired one from the “Analyzer” pull-down list on the QC screen. 2. Select the QC file No. you want to review, and then the screen will display the corresponding information and the graph. 3. You can drag the scroll bar on the right of the graph to browse graphs of the parameters. You can drag the scroll bar under the graph horizontally to browse all the QC results. Introduction to the "Graph" screen 1- The Mean, SD and CV% of all the QC results of each parameter in the current graph. 2- The saving date and time of the QC points on the green line. 3- The operator who run the QC analysis and obtained the QC points on the green line. 4- The QC result corresponding to the QC point on the green line. 5- The line connecting all QC points of the same parameter to show the trend. The QC points in each graph are displayed from left to right according to the sequence from the earliest to the latest. 6- Currently selected QC point. The analysis result of the selected QC point is displayed under the parameter. A black QC point indicates the value is within the limit; a red QC point indicates the value is out of the limit. 7- The green vertical line is used to identify the QC points of the same analysis, all of which are displayed on the line when you select one of them. 8- The sequence number of the QC points on the green line and the total groups of QC points 1 2 3 4 5 6 7 8
Using the QC Programs 8-25 saved currently. NOTE The outliers are excluded from the calculation of Mean, SD and CV%. For the QC files with saved QC results, if any change is made to the targets or the limits, the changed data will be highlighted in yellow. Delete (administrator) You can delete the QC graph data at the administrator level. 1. Click the "Delete" button, and a dialog box will pop up. 2. Select to delete “Current Data” or “All Data”. NOTE Make sure you select the desired data if you choose to delete the “Current Data”. 3. Click the "OK" button to delete specified data and close the dialog box. NOTE The operation of deletion will be recorded in the log. New Vial/Cancel New Vial If the reviewed QC results are obtained by analyzing a new vial of control of the same batch, you should mark the QC points of the new vial to distinguish the QC results from the old.
Using the QC Programs 8-26 1. Move the green line to the first QC point of the new vial. 2. Click the “New Vial” button, and then a blue line appears at the QC point of the new vial. 3. After another new vial of control (within the same batch) is run and its QC results are saved, you can mark the current QC points of the new vial according to step 1 and 2. To cancel a new vial identifier, locate the identifier and then click the “Cancel New Vial” Button Data Compare You can compare the QC graphs of the same parameter obtained by running different batches of control. 1. Click the “Data Compare” button to go to the data compare screen. 2. Select the parameter you want to compare from the “Para.” pull-down list. 3. Specify 2-3 file numbers you want to compare from the “File No.” pull-down lists, and the corresponding information and graph will be displayed. 4. Use the arrow buttons at the bottom to move to the first/previous/next/last QC point. 5. Click “Print” to print the screen if needed. 6. Click “Close” to exit.
Using the QC Programs 8-27 NOTE The color of lines connecting the QC points in a QC file differs according to the level of the control. The colors are defined on bottom left of the “Data Compare” screen (L=low level; M=Normal Level; H=high level). Adjust the sequence of parameters (administrator) You can adjust the sequence of the parameters displayed in the QC graph at the administrator level. Do as follows to adjust the sequence of parameters displayed in the QC graph screen. 1. Click the "Sequence" button, and a dialog box will pop up. 2. Select the parameter that you want to adjust. 3. Use the order adjusting buttons to move it upwards/downwards/to top/to bottom. 4. Click the "OK" button to save the change and close the dialog box.
Using the QC Programs 8-28 Calculate and Save Preset Values (administrator) If there are 3 or more QC results within the limits for a QC parameter, you can take the following steps to calculate and save the preset value for the parameter: 1. Click the "Calculate Preset Values" button, and then two black lines are displayed to locate the range for calculating the preset values. 2. Click and drag the two lines respectively to locate them at the beginning and the end of the range for calculating the preset values. 3. The Mean, SD and CV% (on the right of the graph) will change into that of the new results which are obtained by calculating within the selected range. 4. If you want to save the new results, you can click the "Save Preset Values" button to save the current Mean, SD and CV% as the preset values for the corresponding levels (high/normal/low).Then, the two selecting lines disappear and the Mean, SD and CV% return to the calculated results of all QC results. NOTE The calculation and display of the preset values are only available when a parameter (within the calculation range) has 3 or more than 3 results within the limit. Otherwise, the preset values will be empty. Three sets of preset values (for high, normal and low levels of the controls respectively) can be saved in all. Enters the reasons for the outliers (administrator) You can enter the reasons for an outlier at the administrator level. 1. After moving the green line to the desired QC point, you can click the "Outliers" button to display the QC results, targets and limits of all the parameters (the QC results exceeding the limit will be displayed in red) and enter the reasons for the outliers.
Using the QC Programs 8-29 2. You can select reasons from the given ones or select the option "Other" and then enter the reasons into the text box manually (up to 200 characters). 3. Click “OK” to save and exit. NOTE If you enter the outlier reason for the group of QC points whose results are actually within the limits, then their corresponding QC data both in the QC Graph and QC Table will be displayed in red. The data will return to be black if you cancel the outlier reason and then save the changes. Print Click the "Print" button to print all the QC file information and graphs of the QC parameters. NOTE The green line and the corresponding values of the QC points will not be printed. Print Preview Click “Preview”, the “Print Preview” window will pop up displaying the preview of the QC graph. Click the “Close” button to exit.
Using the QC Programs 8-30 L-J QC table review 1. Click "QC", and then select "L-J QC" from the "QC Program" pull-down list. NOTE If the PC used to be connected to different analyzers, select the desired one from the “Analyzer” pull-down list on the QC screen. 2. Click the "Table" tab to enter the L-J QC table screen. 3. Select the QC file No. you want to review, and then the screen will display the corresponding information and the QC table. 4. You can drag the scroll bar on the right of the table vertically to browse QC results of the desired parameters. You can drag the scroll bar below the table horizontally to browse all QC results.
Using the QC Programs 8-31 Introduction to the "Table" screen 1- The sequence number of the QC results saved in the QC file (earliest to the latest from left to right) 2- QC Result 3- QC parameters (displayed in the same order as the Graph screen) 4- QC flag: The flag "H" or "L" (or other flags configured in “General Setup” of the DMU) will mark the results that are out of the limits 5- The relative position of the highlighted QC point and the total QC points saved currently. NOTE For the QC files with saved QC results, if any change is made to the target or the limits, the changed data will be highlighted in yellow. Delete (administrator) You can delete the QC table data at the administrator level. 1. Click the "Delete" button, and a dialog box will pop up. 1 2 3 5 4
Using the QC Programs 8-32 2. Select to delete “Current Data” or “All Data”. NOTE Make sure you select the desired data if you choose to delete the “Current Data”. 3. Click the "OK" button to delete specified data and close the dialog box. NOTE The operation of deletion will be recorded in the log. Print 1. Click the "Print" button, and a dialog box will pop up. 2. Select to print “All Data” or “Specified Data”. If the “Specified Data” is selected, you should enter or select the starting and ending date to specify the range of data to be printed.
Using the QC Programs 8-33 3. Click “OK” to start printing and close the dialog box. Print preview 1. Click the "Preview" button, and a dialog box will pop up. 2. Select to check the print preview of “All Data” or “Specified Data”. If the “Specified Data” is selected, you should enter or select the starting and ending date to specify the range of data of which you want to check the print preview. 3. Click “OK” to go to the print preview window. 4. Click the “Close” button to close the window. Communication If you want to transmit QC results to external data management software or LIS/HIS, do as follows: 1. Click the "Communication" button, and a dialog box will pop up. 2. Select to transmit “All Data” or “Specified Data”. If the “Specified Data” is selected, you should enter or select the starting and ending date to specify the range of data you
Using the QC Programs 8-34 want to transmit. 3. Click the "Start" button to start transmitting data. NOTE If auto-communication is enabled and a sample is run during the transmission of the QC data, then only when the QC data transmission finished will the auto-communication of the sample result start. The QC data saved in the process of transmission will not be transmitted. Data Export (administrator) If you want to export the information and the result of the current QC file, do as follows: 1. Click the "Data Export" button, a dialog box will pop up. 2. Select the export directory in the pop up box. 3. Edit the file name of the data to be exported if needed. 4. Select the format of the data to be exported. (default format: “.csv”) 5. Click the "Save" button to start the export. NOTE You can modify the exported data if needed but cannot check the data at the "History" screen. You can click the "Cancel" button to cancel exporting when it is in process. Edit and save result (administrator) You can select and edit results at the administrator level. After editing, click the "Save" button to save the change. A flag "E" will be marked after the results that have been edited. Restore result (administrator) You can restore the initial measurement results after editing them at the administrator level. 1. Click the "Restore" button.
Using the QC Programs 8-35 2. Select to restore “Current Data” or “All Data”. NOTE Make sure you select the desired data if you choose to restore the “Current Data”. 3. Click the "OK" button to delete specified data and close the dialog box. Parameter QC graph 1. Click "QC", and then select "L-J QC" from the "QC Program" pull-down list. NOTE If the PC used to be connected to different analyzers, select the desired one from the “Analyzer” pull-down list on the QC screen. 2. Click the "Parameter QC Graph" tab to enter the parameter QC graph screen.
Using the QC Programs 8-36 Introduction to the “Parameter QC Graph” screen The parameter QC graph screen consists of the file information area, QC graph area and the comments area. File information area You can select among all valid QC file No. from the “File No.” pull-down list. The default file No. is the L-J QC file used by the current operator, and the file No. cannot be null. The lot No, level, exp. date, source of control QC test panel, editor and QC sample ID will be displayed automatically after you select the QC file No.. QC graph area You can select the parameter to plot QC graph from the “Parameter” pull-down list, and select the QC point plotting mode from the “QC Point” pull down list: “By Date of QC”, “1 per day Sequential”, “All”. The default values of the “X Mean” and “SD” boxes are calculated from all the valid QC points on the graph of the selected parameter in the current QC file by the default plotting mode. You can edit the values manually. If there are less than 3 valid QC points of the current parameter, the mean and SD will be null. If you select “By QC Date” or “1 per Day sequential” plotting mode, and there are more than 1 QC point in one day, the points will all be displayed in the graph, but only the latest one will be the connecting point of the plot.
Using the QC Programs 8-37 Drag the scroll bar after setting up all the information, and the QC graph will be plotted automatically and the analysis results and operator information will be displayed under the graph. QC analysis and flag area This area displays the conclusion drawn based on the preset rule of outliers (see Set rule of outliers in this section for details). Calculate Target 1. Click the “Calculate Target” button, the following screen will pop up. 2. After selecting the date range, the X mean, SD and CV will be calculated and displayed in to the corresponding boxes automatically. 3. Click “Apply” to enter the calculated target into the parameter QC graph screen. 4. Click “OK” to save the target and close the dialog box. If there are no data in the selected date range, a prompt will be displayed asking you to reselect a date range and make sure there are more than 5 groups of valid data.” Save Click “Save” to save the mean and SD (including the manually edited values and the values obtained by calculating target). New Vial/Cancel New Vial If the reviewed QC results are obtained by analyzing a new vial of control of the same batch, you should mark the QC points of the new vial to distinguish the QC results from the old.
Using the QC Programs 8-38 1. Move the green line to the first QC point of the new vial. 2. Click the “New Vial” button, and then a blue line appears at the QC point of the new vial. 3. After another new vial of control (within the same batch) is run and its QC results are saved, you can mark the current QC points of the new vial according to step 1 and 2. To cancel a new vial identifier, locate the identifier and then click the “Cancel New Vial” Button Set rule of outliers 1. Click the “Rule of Outliers” button, and a dialog box will pop up. 2. Tick the “Effective” check box of the desired rules. 3. Click “OK” to save and exit. Print Click the "Print" button to print all the QC file information and graphs of the QC parameters. NOTE The green line and the corresponding values of the QC points will not be printed. Print Preview Click “Preview”, the “Print Preview” window will pop up displaying the preview of the QC graph. Click the “Close” button to exit.
Using the QC Programs 8-39 Monthly QC graph 1. Click "QC", and then select "L-J QC" from the "QC Program" pull-down list. NOTE If the PC used to be connected to different analyzers, select the desired one from the “Analyzer” pull-down list on the QC screen. 2. Click the "Monthly QC Graph" tab to enter the monthly QC graph screen. Introduction to the “Monthly QC Graph” screen The monthly QC graph screen consists of the file information area and QC graph area. File information area You can select the desired year and month of QC analyses from the “QC Year” and “QC Month” pull-down lists, and the parameter you want to plot, level of control, and way of plotting the QC points from the “Para.”, “Level” and “QC Point” pull-down lists. After you set the above conditions, the matching QC files will be acquired and the Lot No., exp. Date, X mean and SD will be displayed in the area of the corresponding QC levels. If no data is acquired, the boxes will be null. If the “X Mean” and “SD” boxes are both null, their values cannot be edited, otherwise you can edit the values of X mean and SD, then click “Save” to save the change.
Using the QC Programs 8-40 Two QC files of each QC level can be displayed in one month; if there are more than two QC files, the latest two will be displayed. QC graph area Drag the scroll bar after setting up all the information, the QC graph will be plotted automatically and the QC point No., analysis results and operator information will be displayed under the QC graph. If there are QC points in the graph, the Lot No., X mean, SD and CV% will be displayed above the graph. Each screen of the QC graph can display 31 groups of QC data. To view more QC data, drag the horizontal scroll bar. Print Click the "Print" button to print all the QC file information and graphs of the QC parameters. NOTE The green line and the corresponding values of the QC points will not be printed. Print Preview Click “Preview”, the “Print Preview” window will pop up displaying the preview of the QC graph. Click the “Close” button to exit.
Using the QC Programs 8-41 8.3 X-B QC Program 8.3.1 Introduction to X-B QC Program The X-B analysis is a weighted moving average analysis that uses values obtained from patient samples. It uses the 3 red cell indices, MCV, MCH and MCHC to indicate the hematology instrument performance. Effective use of X-B requires randomization of samples and a normal cross section of patients to prevent skewing of indices. It is recommended the X-B analysis be activated when the sample volume of your laboratory is greater than 100 samples per day. The analyzer implement X-B QC on the 3 parameters: MCV, MCH and MCHC, each group of samples for X-B analysis consists of 20-200 sample results obtained from normal analysis of both WB and PD modes. The analyzer can save up to 1000 X-B QC results. When the saved QC results have reached the maximum number, the newest result will overwrite the oldest. 8.3.2 QC Setup (Administrator) All the samples, controls, calibrators, reagents, wastes and areas contacted by them are potentially biohazardous. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them and the contacted areas in the laboratory. 1. Click "QC”, and then select "X-B QC" from the "QC Program" pull-down list. NOTE If the PC used to be connected to different analyzers, select the desired one from the “Analyzer” pull-down list on the QC screen. 2. Click the “Setup” button to go to the X-B QC setup screen.
Using the QC Programs 8-42 At the X-B QC setting screen, you can configure the “X-B QC” information, “Target/Limit” and “Sample Validity Setup”. QC information setup 1. In the "Samples/Batch" text box of the X-B QC setup screen, you can enter the amount of samples (shall be within the range from 20 (default) to 200) to be included in calculating for an X-B QC point. 2. Select “On” to enable the X-B QC, and then all samples compliant with the sample validity setup will be included in the X-B QC calculation; or Select “Close” to disable the X-B QC. Target/Limit setup Before the X-B QC analysis, you shall set up the target and limit for each parameter at the X-B QC setup screen using one of the following ways: Manual entry Reading the saved preset values.
Using the QC Programs 8-43 NOTE The units for the targets and limits conform to the configuration at the “Para. Unit” setup screen. See 5.3.5 Para. Unit (Administrator) ("Setup" > "Para. Unit ") for details. Manual Entry 1. In the “Target/Limit” area of the X-B QC setup screen, specify the targets and limits in the “Target/Limit” table by entering manually. NOTE Do not leave any of the targets and limits for the QC parameters blank. When first use, the default setting will provide the initial values for the targets and limits of all QC parameters. 2. Click the "Save" button to save the changes. Reading the Saved Preset Values NOTE If there are saved preset values (Target and Limits) for the X-B QC, you can read the preset values into the X-B QC setup screen. For details of calculating and saving the preset values, see Section 8.3.4 Reviewing X-B QC results. 1. In the X-B QC setup screen, click the "Get Preset Values" button to read the saved preset target and limits into the X-B QC setup screen. NOTE Do not leave any of the targets and limits for the QC parameters blank. If some of the parameters do not have preset values, you shall enter them manually. 2. Click the "Save" button to save the changes.
Using the QC Programs 8-44 Setting Limits Do as follows to adjust the display format of the limits and the calculation method of the preset limits. 1. In the X-B QC setup screen, click the “Set Limits” button, and then the following dialog box will pop up. 2. Click “By SD” to display the limits in the form of absolute value; or Click “By CV” to display the limits in the form of percentage. 3. If “By SD” is selected, click the “2SD” or “3SD” to select either double or triple standard deviation to be the preset limits; If “By CV” is selected, click the “2CV” or “3CV” to select either double or triple coefficient of variation to be the preset limits. 4. Click the “OK” button to save and close the dialog box. Restoring defaults If needed, you can restore the targets and limits to the default values by clicking the "Restore Defaults" button to read the defaults to the X-B QC setup screen. The default target for each parameter: Parameter Target Limit (#) MCV 89.5 2.7 MCH 30.5 0.9 MCHC 340 10 Sample validity setup In X-B QC, sample results conforming to any of the following conditions will be considered as invalid and cannot be used in the QC calculation.
Using the QC Programs 8-45 Sample results exceeding the linearity range; Background results; Sample results not conforming to the "Sample Validity Setup"; QC data for L-J, X mean and X mean R QC; Calibration data; Results generated while there are errors which could affect the accuracy of the results (insufficient aspiration volume or clogging for example). "Sample Validity Setup" is to set up the ranges of valid RBC, MCV, MCH and MCHC results. Only when the results of all these four parameters are within the specified ranges, the sample results can be used for X-B QC calculation. Do as follows to set the sample validity: 1. In the "Sample Validity Setup" of the X-B QC setup screen, set the upper and lower limits of the 4 parameters in the sample validity setup area. The default validity range of each parameter is shown in the following figure. 2. Click "Save" to save the setup. NOTE In the sample validity setup, the upper limit shall be no smaller than the lower limit. Otherwise, there will be prompted message asking you to revise. The valid ranges of the RBC parameters are their linearity ranges; the valid ranges of other parameters are their display ranges. All the entries shall be numbers with only one decimal point. The length of the number entered cannot be longer than the length of the text box. Once the validity range is changed, the previous results will not be used in the QC calculation as valid results. For example, if 20 valid samples are needed for the X-B QC calculation, when you change the validity range after 10 groups of valid sample results have been acquired, these 10 groups of results will be discarded, and only valid sample results generated afterwards will be used in the QC calculation. The units for the lower and upper limits conform to the configuration at the “Para. Unit” setup screen. See 5.3.5 Para. Unit (Administrator) ("Setup" > "Para. Unit ") for details.
Using the QC Programs 8-46 8.3.3 Running Controls All the samples, controls, calibrators, reagents, wastes and areas contacted by them are potentially biohazardous. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them and the contacted areas in the laboratory. After editing X-B setup, the system will start X-B run automatically. After every 20~200 results (determined by the setting) are obtained, the system will perform the X-B calculation once automatically. You can review the result in X-B QC graph or X-B QC table. 8.3.4 Reviewing X-B QC results After QC analysis, you can review the QC results in the following two ways: QC Graph QC Table X-B QC graph review 1. Click "QC”, and then "X-B QC" from the "QC Program" pull-down list to enter the X-B QC graph screen.
Using the QC Programs 8-47 NOTE If the PC used to be connected to different analyzers, select the desired one from the “Analyzer” pull-down list on the QC screen. 2. You can drag the scroll bar on the right of the graph to browse graphs of the parameters. You can drag the scroll bar under the graph horizontally to browse all the QC results. Introduction to the "Graph" screen 1- The Mean, SD and CV% of all the QC results of each parameter in the current graph. 2- The saving date and time of the QC points on the green line. 3- The QC result corresponding to the QC point on the green line. 4- The line connecting all QC points of the same parameter to show the trend. The QC points in each graph are displayed from left to right according to the sequence from the earliest to the latest. 5- Currently selected QC point. The analysis result of the selected QC point is displayed under the parameter. A black QC point indicates the value is within the limit; a red QC point indicates the value is out of the limit. 6- The green vertical line is used to identify the QC points of the same analysis, all of which are displayed on the line when you select one of them. 7- The sequence number of the QC points on the green line and the total groups of QC points saved currently. 1 2 5 6 7 3 4
Using the QC Programs 8-48 NOTE The outliers are excluded from the calculation of Mean, SD and CV%. Delete (administrator) You can delete the QC graph data at the administrator level. 1. Click the "Delete" button, and a dialog box will pop up. 2. Select to delete “Current Data” or “All Data”. NOTE Make sure you select the desired data if you choose to delete the “Current Data”. 3. Click the "OK" button to delete specified data and close the dialog box. NOTE The delete operation will be recorded in the log. Calculate and Save Preset Values (administrator) If there are 3 or more QC results within the limits for a QC parameter, you can take the following steps to calculate and save the preset value for the parameter: 1. Click the "Calculate Preset Values" button, and then two black lines are displayed to locate the range for calculating the preset values. 2. Click and drag the two lines respectively to locate them at the beginning and the end of the range for calculating the preset values.
Using the QC Programs 8-49 3. The Mean, SD and CV% (on the right of the graph) will change into that of the new results which are obtained by calculating within the selected range. 4. If you want to save the new results, you can click the "Save Preset Values" button to save the current Mean, SD and CV% as the preset values for the corresponding levels (high/normal/low).Then, the two selecting lines disappear and the Mean, SD and CV% return to the calculated results of all QC results. NOTE The calculation and display of the preset values are only available when a parameter (within the calculation range) has 3 or more than 3 results within the limit. Otherwise, the preset values will be empty. Three sets of preset values (for high, normal and low levels of the controls respectively) can be saved in all. Print Click the "Print" button to print all the QC file information and graphs of the QC parameters. NOTE The green line and the corresponding values of the QC points will not be printed. Print Preview Click “Preview”, the “Print Preview” window will pop up displaying the preview of QC graph. Click the “Close” button to exit. X-B QC table review 1. Click "QC”, and then select "X-B QC" from the "QC Program" pull-down list. NOTE If the PC used to be connected to different analyzers, select the desired one from the “Analyzer” pull-down list on the QC screen. 2. Click the “Table” button to go to the X-B QC table review screen.
Using the QC Programs 8-50 3. You can drag the scroll bar on the right of the table vertically to browse QC results of the desired parameters. You can drag the scroll bar below the table horizontally to browse all QC results. Introduction to the "Table" screen 1- The sequence number of the QC results saved in the QC file (earliest to the latest from left to right) 2- QC Result 3- QC parameters (displayed in the same order as the Graph screen) 4- QC flag: The flag "H" or "L" (or other flags configured in “General Setup” of the DMU) will mark the results that are out of the limits 5- The relative position of the highlighted QC point and the total QC points saved currently. Delete (Administrator) You can delete the QC table data at the administrator level. 1 2 3 5 4
Using the QC Programs 8-51 1. Click the "Delete" button, and a dialog box will pop up. 2. Select to delete “Current Data” or “All Data”. NOTE Make sure you select the desired data if you choose to delete the “Current Data”. 3. Click the "OK" button to delete specified data and close the dialog box. NOTE The delete operation will be recorded in the log. Print 1. Click the "Print" button, and a dialog box will pop up. 2. Select to print “All Data” or “Specified Data”. If the “Specified Data” is selected, you
Using the QC Programs 8-52 should enter or select the starting and ending date to specify the range of data to be printed. 3. Click “OK” to start printing and close the dialog box. Print preview 1. Click the "Print Preview" button, and a dialog box will pop up. 2. Select to check the print preview of “All Data” or “Specified Data”. If the “Specified Data” is selected, you should enter or select the starting and ending date to specify the range of data of which you want to check the print preview. 3. Click “OK” to go to the print preview window. 4. Click the “Close” button to close the window. Communication If you want to transmit QC results to external data management software or LIS/HIS, do as follows: 1. Click the "Communication" button, and a dialog box will pop up.
Using the QC Programs 8-53 2. Select to transmit “All Data” or “Specified Data”. If the “Specified Data” is selected, you should enter or select the starting and ending date to specify the range of data you want to transmit. 3. Click the "Start" button to start transmitting data. NOTE If auto communication is enabled and a sample is run during the transmission of the QC data, then only when the QC data transmission finished will the auto-communication of the sample result start. The QC data saved in the process of transmission will not be transmitted. Data Export (administrator) If you want to export the information and the result of the current QC file, do as follows: 1. Click the "Data Export" button, a dialog box will pop up. 2. Select the export directory in the pop up box. 3. Enter the file name of the data to be exported. 4. Select the format of the data to be exported. (default format: “.csv”) 5. Click the "Save" button to start the export. NOTE You can modify the exported data if needed but cannot check the data at the "History" screen. You can click the "Cancel" button to cancel exporting when it is in process.
Using the QC Programs 8-54 8.4 X Mean QC Program 8.4.1 QC Setup (Administrator) All the samples, controls, calibrators, reagents, wastes and areas contacted by them are potentially biohazardous. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them and the contacted areas in the laboratory. NOTE If the "In Use" check box of a QC file is ticked, the QC information will be transmitted to the SPU when the connection is built up, and the matching QC results will be saved in this file. Before analyzing a new batch of controls with the X mean program, you should set up a QC file for each lot of controls. 1. Click "QC”, and then select "X mean QC" from the "QC Program" pull-down list. NOTE If the PC used to be connected to different analyzers, select the desired one from the “Analyzer” pull-down list on the QC screen. 2. Click the “Setup” button to go to the X mean QC setup screen.
Using the QC Programs 8-55 To set up the QC file, you shall enter the required “File Info.” and “Target/Limit” using one of the following ways: Reading the information provided by the manufacturer Manual entry Reading the saved preset values. There are 3 columns which cannot be edited in the “File Info.” table: File No. (Sequence number of the QC file) Editor (the information of the user who edited the file, in the format of “User ID(User Name)”) Existing Data/Capacity (number of existing records for the file/the maximum records that can be saved in the file) Reading the information provided by the manufacturer 1. Click "QC”, and then select "X mean QC" from the "QC Program" pull-down list. NOTE If the PC used to be connected to different analyzers, select the desired one from the “Analyzer” pull-down list on the QC screen. 2. Click the “Setup” button to go to the X mean QC setup screen. 3. Select an empty QC file (ranging from 1 to 60) from the “File Info.” table. 4. Click the “Read File” button, a message box will pop up.
Using the QC Programs 8-56 5. Click the "Browse" button, and then select the path to read QC information. 6. Click "OK" to close the box, the dialog box below will display. NOTE The QC files for selection are displayed in the format of "Batch No. (level)". 7. Select a QC file and click "OK" to close the dialog box and return to the "Read File" dialog box. The path selected will be displayed.
Using the QC Programs 8-57 8. Select "Read Target/Limit", and then click "OK" to import the QC information into the current QC file. NOTE If the “Read Target/Limits” is not selected, you have to enter the target and limits manually. 9. Select the source of control from the pull-down list. 10. Select the presentation mode, sample mode and test panel of the QC analyses from the pull-down lists (see 6.7.1 Selecting work mode for indications of test panel abbreviations). 11. Tick the “In Use” box if needed. 12. Click the “Save” button to save the QC information. NOTE The expiration date shall not be earlier than the current system date. Manual entry 1. Click "QC”, and then select "X mean QC" from the "QC Program" pull-down list. NOTE If the PC used to be connected to different analyzers, select the desired one from the “Analyzer” pull-down list on the QC screen. 2. Click the “Setup” button to go to the X mean QC setup screen.
Using the QC Programs 8-58 3. Select an empty QC file (ranging from 1 to 60) from the “File Info.” table. 4. You can enter the lot No. of the controls by one of the following ways: Manual entry Using external barcode scanner NOTE The lot No. shall not be empty and up to 16 digits can be entered. You can enter characters, numbers, letters and special characters, but Chinese characters are not allowed. 5. Select the control level from the pull-down list (L for low level, N for normal level and H for high level). 6. Enter the expiration date of the batch, or click the pull-down arrow to select the expiration date from the date control. NOTE The format of the expiration date is determined by the configuration of the PC. The expiration date shall not be earlier than the current system date. 7. Select the source of control from the pull-down list. 8. Select the presentation mode, sample mode and test panel of the QC analyses from the pull-down lists (see 6.7.1 Selecting work mode for indications of test panel abbreviations). 9. Tick the “In Use” box if needed.
Using the QC Programs 8-59 10. Enter the targets and limits manually according to the package insert for the batch of controls. 11. Click the “Save” button to save the QC information. Reading the saved preset values NOTE If there are the saved preset values (Target and Limits) for the current level, you can read-in the preset values into the current QC file. For details of calculating and saving the preset values, see Section 8.4.3 Reviewing X mean QC results. 1. Click "QC”, and then select "X mean QC" from the "QC Program" pull-down list. NOTE If the PC used to be connected to different analyzers, select the desired one from the “Analyzer” pull-down list on the QC screen. 2. Click the “Setup” button to go to the X mean QC setup screen. 3. Select an empty QC file (ranging from 1 to 60) from the “File Info.” table. 4. You can enter the lot No. of the controls by one of the following ways: Manual entry Using external barcode scanner
Using the QC Programs 8-60 NOTE The lot No. shall not be empty and up to 16 digits can be entered. You can enter characters, numbers, letters and special characters, but Chinese characters are not allowed. 5. Select the control level from the pull-down list (L for low level, N for normal level and H for high level). 6. Enter the expiration date of the batch, or click the pull-down arrow to select the expiration date from the date control. NOTE The format of the expiration date is determined by the configuration of the PC. The expiration date shall not be earlier than the current system date. 7. Select the source of control from the pull-down list. 8. Select the presentation mode, sample mode and test panel of the QC analyses from the pull-down lists (see 6.7.1 Selecting work mode for indications of test panel abbreviations). 9. Tick the “In Use” box if needed. 10. Click the “Get Preset Values” button to read-in the saved preset targets and limits (corresponding to the current level) into the current QC file. NOTE If some parameters to be included in the QC run have no preset values, you should enter the target and limits for them manually; if you don't want some parameters with preset values to be included in the QC run, you can delete the target and limits of those parameters manually after read-in the preset values. 11. Click the “Save” button to save the QC information. Setting Limits Do as follows to adjust the display format of the limits and the calculation method of the preset limits. 1. Click the “Set Limits” button, and then the following dialog box will pop up.
Using the QC Programs 8-61 2. Click “By SD” to display the limits in the form of absolute value; or Click “By CV” to display the limits in the form of percentage. 3. If “By SD” is selected, click the “2SD” or “3SD” to select either double or triple standard deviation to be the preset limits; If “By CV” is selected, click the “2CV” or “3CV” to select either double or triple coefficient of variation to be the preset limits. 4. Click the “OK” button to save and close the dialog box. 8.4.2 Running Controls After editing the QC information, you can start QC analysis by one of the following ways in the selected QC mode. OV-WB AL-WB All the samples, controls, calibrators, reagents, wastes and areas contacted by them are potentially biohazardous. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them and the contacted areas in the laboratory.
Using the QC Programs 8-62 WARNING The sample probe is sharp and potentially biohazardous. Exercise caution to avoid contact with the probe when working around it. The sample may spill from the uncapped collection tubes and cause biohazard. Exercise caution to the uncapped collection tubes. The breaking of collection tubes may cause personal injury and/or biohazard. Exercise caution when loading the collection tubes to the rack or getting the collection tubes from the rack, be sure not to break the tubes. Keep you clothes, hairs and hands away from the moving parts to avoid injury. The reagents are irritating to eyes, skin and diaphragm. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them in the laboratory. If the reagents accidentally spill on your skin, wash them off with plenty of water and if necessary, go see a doctor; if the reagents accidentally spill into your eyes, wash them off with plenty of water and immediately go see a doctor. CAUTION Do not re-use disposable products like collection tubes, test tubes, capillary tubes, etc. Sample aggregation may result in inaccurate analysis result. Check if the control is agglutinated before analysis, if yes, handle per the operation requirements of your laboratory. NOTE Be sure to use the Mindray-specified disposable products including evacuated blood collection tube, centrifugal tubes and capillary tubes etc. If the sample mode is switched from the "Predilute" to "Whole Blood", the analyzer will perform the switching sequence automatically and a progress bar will be displayed on the screen.
Using the QC Programs 8-63 OV-WB NOTE After starting analysis, do not open the front cover of the analyzer. The sample probe should be kept away from the tube bottom when the probe is aspirating sample. Otherwise, the aspirated volume may be imprecise. The probe tip should not contact the sample tube. Otherwise, the blood may spill. 1. Click the MENU button on the screen, and then select "QC" on the pop-up menu. 2. Click "Setup" button, the QC setup dialog box will pop up.
Using the QC Programs 8-64 3. Select “QC Type” as "X mean QC" and select the QC file of the control to be run, and then click "OK" to return to the QC screen. NOTE Be sure that the level of the control to be run is the same with the current QC file, and the control is not expired. The expiration date of expired controls is displayed in red. 4. Prepare the control as instructed by instructions for use of the controls. 5. Run QC analysis: 1) Make sure the analysis mode is "OV-WB" and the indicator of the analyzer is green. 2) Wave the whole blood sample as instructed by below picture to mix the sample thoroughly. 3) Click "Start Count" button. 4) Present the whole blood sample to the sample probe. 5) Press the aspirate key to start QC run.
Using the QC Programs 8-65 6) When you hear the beep, remove the control. 6. When analysis finishes, the QC results will be displayed in the current screen and be saved in the QC file automatically. NOTE Up to 372 QC results can be saved in each QC file. 7. Do the above procedures to continue running QC analysis if necessary. AL-WB All the samples, controls, calibrators, reagents, wastes and areas contacted by them are potentially biohazardous. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them and the contacted areas in the laboratory. WARNING The sample probe is sharp and potentially biohazardous. Exercise caution to avoid contact with the probe when working around it. The sample may spill from the uncapped collection tubes and cause biohazard. Exercise caution to the uncapped collection tubes. Be sure to avoid reversing the collection tube when loading, otherwise, the collection tube may be broken and biohazard may occur. The breaking of collection tubes may cause personal injury and/or biohazard. Exercise caution when loading the collection tubes to the rack or getting the collection tubes from the rack, be sure not to break the tubes. The breaking of collection tubes may cause personal injury and/or biohazard. Exercise caution when loading the collection tubes to the autoloader or getting the collection tubes from the autoloader, be sure not to break the tubes. The pusher will push the rack inside the autoloader. Be sure your hand is away from the rack before starting the autoloader. Keep you clothes, hairs and hands away from the moving parts to avoid injury. The reagents are irritating to eyes, skin and diaphragm. Wear proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when handling them in the laboratory.
Using the QC Programs 8-66 If the reagents accidentally spill on your skin, wash them off with plenty of water and if necessary, go see a doctor; if the reagents accidentally spill into your eyes, wash them off with plenty of water and immediately go see a doctor. CAUTION Do not re-use disposable products like collection tubes, test tubes, capillary tubes, etc. NOTE After starting analysis, do not open the front cover of the analyzer. If abnormal power interruption occurs after analysis is started, you should remove the racks manually and open the front cover to see if there are dropped tubes to be removed. Be sure to use the Mindray-specified disposable products including evacuated blood collection tube, centrifugal tubes and capillary tubes etc. 1. Click the MENU button on the screen, and then select "QC" on the pop-up menu. 2. Click "Setup" button, the QC setup dialog box will pop up.
Using the QC Programs 8-67 3. Select “QC Type” as "X mean QC" and select the QC file of the control to be run, and then click "OK" to return to the QC screen. NOTE Be sure that the level of the control to be run is the same with the current QC file, and the control is not expired. The expiration date of expired controls is displayed in red. 4. Prepare the control as instructed by instructions for use of the controls, and paste barcode labels to the control vials (for details about pasting barcodes, see 6.8.4 Barcode Labels). 5. Run QC analysis: 1) Make sure the QC mode is "AL-WB" and the analysis status icon and analyzer indicator is green. 2) Make sure the barcode labels are well pasted to the containers of the controls. 3) Click "Start Count" button. 4) Present the prepared control into the rack. 5) Place racks loading controls on the right tray of the autoloader, with the back of "MINDRAY" mark on the carrier facing the analyzer. 6) Press the [Count] key or click the "Count" button on the dialog box to start running. 7) When the running completes, you can remove the racks from the left of the autoloader. 6. When analysis finishes, the QC results will be displayed in the current screen and be saved in the QC file automatically. NOTE Up to 372 QC results can be saved in each QC file.
Using the QC Programs 8-68 7. Do the above procedures to continue running QC analysis if necessary. 8.4.3 Reviewing X mean QC results After QC analysis, you can review the QC results in the following two ways: QC Graph QC Table X mean QC graph review 1. Click "QC", and then "X Mean QC" from the "QC Program" pull-down list to enter the X mean QC graph screen. NOTE If the PC used to be connected to different analyzers, select the desired one from the “Analyzer” pull-down list on the QC screen. 2. Select the QC file No. you want to review, and then the screen will display the corresponding information and the graph. 3. You can drag the scroll bar on the right of the graph to browse graphs of the parameters. You can drag the scroll bar under the graph horizontally to browse all the QC results.
Using the QC Programs 8-69 Introduction to the "Graph" Screen 1- The Mean, SD and CV% of all the QC results of each parameter in the current graph. 2- The saving date and time of the QC points on the green line. 3- The operator who run the QC analysis and obtained the QC points on the green line. 4- The QC result corresponding to the QC point on the green line. 5- The line connecting all QC points of the same parameter to show the trend. The QC points in each graph are displayed from left to right according to the sequence from the earliest to the latest. 6- Currently selected QC point. The analysis result of the selected QC point is displayed under the parameter. A black QC point indicates the value is within the limit; a red QC point indicates the value is out of the limit. 7- The green vertical line is used to identify the QC points of the same analysis, all of which are displayed on the line when you select one of them. 8- The sequence number of the QC points on the green line and the total groups of QC points saved currently. NOTE The outliers are excluded from the calculation of Mean, SD and CV%. For the QC files with saved QC results, if any change is made to the targets or the limits, the changed data will be highlighted in yellow. Delete (administrator) You can delete the QC graph data at the administrator level. 1 2 3 4 5 6 7 8