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Sysmex® CA-1500 System Quality Control I Online Training

Perform quality control and use the quality control screen to review, print, and evaluate QC data resulting in comprehensive records for your quality control program. This clinical laboratory training qualifies for continuing education units (CEU).

Welcome to the Sysmex® CA-1500 System Quality Control I Online Training course. Running quality control ensures reliable data over a long period of time and allows for instrument monitoring of the reagent system conditions to prevent inaccurate results from being reported. The Sysmex® CA-1500 System has an onboard quality control package that allows for easy analysis of control plasma and the statistical management of QC results. With the QC software, you can: Enter control plasma reagent information Display QC results Set limits of acceptability for control results Select Next to continue. Upon successful completion of this course, you will be able to: Describe features of the Sysmex® CA-1500 System QC program Describe how to run QC using a Rack worklist Identify key features of the Quality Control screen Identify data displayed in a Levey-Jennings QC chart Select Next to continue. Congratulations. You have completed the Sysmex® CA-1500 System Quality Control I online training course. Listed below are the key points that have been presented. Take time to review the material before you proceed to the final quiz. Describe features of the Sysmex® CA-1500 System QC program The Sysmex® CA-1500 System quality control program provides QC data storage by accumulating data into user-defined QC files—each file stores QC results for a specific control plasma. QC files are linked so that you can compare results of new and current control lots. You can also assign a test parameter's QC results to a display group so that you can view a range of data in a Levey-Jennings QC chart. Describe how to run QC using Rack or Reagent Tray worklists Run control plasma in a sample rack using a Rack worklist, or in a reagent tray using a Reagent Holder worklist. Identify key features of the Quality Control screen Use the Quality Control screen to define or edit display groups, view or print up to three QC charts in a display group, save or read QC data to or from a floppy disk, or edit or delete QC data. Identify data on a QC chart Each QC chart displays a selected range of QC data, individual QC results, QC statistics (such as mean, SD, and CV), and QC error codes (if detected). Select Next to continue. Run QC just as you run patient samples or calibrators: register the sample ID, the tests requested, and the instrument position where the sample is loaded. QC sample IDs match the QC file number. For example: register QC01 as the sample ID on a worklist for the control plasma whose results are stored in QC file 1. Register QC02 as the sample ID on a worklist for the control plasma whose results are stored in QC file 2. To run a QC sample, you have two options: You can register sample order information onto a Rack worklist by using the QC key if you want to load control plasmas using a sample rack—just as you do for routine patient samples—for example, ID# entry for QC would be QC03 or QC3 for QC file 3. You can register sample order information onto a Reagent Holder worklist if you want to load control plasmas using predefined positions in Reagent Tray 2. Select Next to continue. The most common way to run a QC sample is to register the QC sample order information using a Rack worklist and then load the control plasma into a sample rack—just as you do for routine patient samples. To run QC sample using a Rack worklist: From the Main Menu screen, press Work List. On the Work Load List screen, select or verify Rack worklist. Register sample ID and sample rack position. Select tests to run. Load sample into assigned position. Press Start to run QC. Run QC using a Rack Worklist Learn how to order QC using a rack worklist. Instructions:If media does not automatically start, select the play arrow to begin.Flash File:/content/generator/Course_90013628/sim_CA1500_QCI_Rackworklist_scaled/sim_CA1500_QCI_Rackworklist_scaled.htmHTML5 File:/content/generator/Course_90013628/sim_CA1500_QCI_Rackworklist_HTML5_800x600/index.htmlPDF File: Another way to run QC is by loading the control plasma into a predefined position in reagent tray 2 and registering the QC sample order information using a Reagent Holder worklist. When running QC using a Reagent Holder worklist, you must verify control plasma information using the Consumables screen—just as you do when you run calibrators. To run QC using a Reagent Holder worklist: From the Main Menu screen, press Set Reagents. Visually verify control plasma information using the Consumables screen, and then press Return to return to the Main Menu screen. Pour the control plasma into a sample cup and load into assigned position. From the Main Menu screen, press Work List. On the Work Load List screen, register the QC order by selecting Reagent Holder worklist. Select tests to run. Press Start to run QC. Running QC using a Reagent Holder Worklist Learn about running QC using a barcode wand. Using the barcode wand on a daily basis to load reagent vials onboard ensures that you are loading the correct reagent lot number and product ID—this practice is encouraged when loading all reagents EXCEPT control plasmas. This is because: If you use the barcode wand to enter control plasma information, the system inserts a new line on the Reagent Information Setting screen for the control plasma ID and specifies QC file 0 to store its QC results--each time you use the barcode wand to verify QC reagent information! The QC program “gets confused” because it sees multiple QC files with the same control plasma ID all assigned to QC file 0. So, to avoid confusion, when loading control plasmas using a Reagent Holder worklist, we recommend using sample cups for QC and visually verifying the product ID, lot number, and expiration date in the control plasma vial label. When complete, select the X in the upper-right corner to close the window and continue, After running QC, you can view QC results on the Stored Data List screen—just as you view patient sample results. To view stored QC results: From the Main Menu screen, press Stored Data to open the Stored Data List screen, which can display either sample information or analysis results. To toggle back and forth between sample information or analysis displays, press the Left or Right arrow keys. Select Next to continue. Use the Quality Control screen to perform several tasks, such as the following: Define, view, edit, or delete a display group. Change the scale of the QC charts currently displayed. Print a QC chart, or save or read QC data to or from a floppy disk. Edit or delete QC data. Quality Control Screen Learn about the quality control screen. Base ImageHotspotsText BlocksImage FileIndicates the data points currently displayed.Group: Indicates the number and name of the display group.You can view up to three QC charts per screen.Press Display Data to view the data currently displayed in a list format.For a selected QC chart, select Display Cur/New to simultaneously display QC results from a new control plasma lot and the current control plasma lot.Press Select Group to select an alternative display group to view or define a new group.Press Change Scale to alternate between QC chart scales--you can view either 60 or 180 data points per QC chart.Press Output/Input to output selected QC data to a graphics printer, save selected QC data to a floppy disk, or read saved QC data from a floppy disk.  Press Delete Data to delete selected QC data that is no longer needed.  For a selected QC chart, press QC Settings to view or edit the way the QC software applies QC rules when evaluating the QC results for a selected test parameter within a QC file.  For a selected QC chart, press the Left or Right arrow keys to move the cursor to the left or right to select a data point. QC results for the selected data point appear in the Cursor area on the right.  Press Select Data to select the data that appears in the QC chart--you can view QC data that encompasses All Data or only Monthly Means. You can further define the data displayed to include only specified time periods during a 24-hour shift. On the Quality Control screen, select the display group that you want to view so that you can evaluate a range of QC results in a Levey Jennings QC chart. Evaluating data in a Levey-Jennings chart allows your laboratory to interpret individual control results to determine if patient test results can be reported and, if not, what type of errors are occurring in out-of-control runs. Press the Select Group key to select an alternative display group to view, or to define a new display group. Press the Change Scale key to alternate between QC chart scales—you can view either 60 or 180 data points per QC chart. Press the Output/Input key to print a QC chart or save QC data to a floppy disk. Press the QC Settings key to view or edit the QC rules that the program uses to evaluate the QC results displayed in the chart. Press the Display Data key to change the display to a list. Press the Select Data key to view either All Data or only Monthly Means. Levey-Jennings QC Chart on QC screen Learn how to identify data in a Levey-Jennings QC chart. Base ImageHotspotsText BlocksImage FileIf a QC file number and test parameter appear green, it’s selected so that you can edit or view that particular test parameter’s QC results--simply press another QC chart to select another QC chart.  Indicates the QC control plasma parameter and QC file number, where results are stored.Indicates the activity level of the control plasma. You can select the level for each control plasma. Activity level can range from 1 to 9. You can also enter alphabetical character such as N for normal.Indicates the name of the control plasma.  Indicates the lot number of the control plasma.  Indicates the expiration date of the control plasma.  Y-axis parameters for the QC chart depend on the check method used to evaluate QC results for a test parameter: Control Limit or Westgard Multirule.  The Levey-Jennings QC chart displays either 60 or 180 data points--depending on the selected scale. The Y-axis displays QC results centered on the mean value with standard deviations indicating upper and lower acceptability limits. The X-axis displays time intervals.   QC results that correspond to the cursor position in the QC chart to the left appear here. Data includes: QC analysis result Date/Time analyzed Shift classification (if implemented) Check method error information codes. If the QC program detects a violation of a QC rule, the system logs an error message and displays an error code on the Quality Control screen. QC statistics for a range of selected data appear here. Data includes N (number of control data specified), Mean, SD (standard deviation), and CV (coefficient of variation).  The vertical cursor in a QC chart indicates the selected data point for data that appears in the Cursor area. For a selected QC chart, press the Left or Right arrow keys to move the cursor to the left or right to select a data point.   You can specify either Control Limit or Westgard Multirule check methods to evaluate QC results for individual test parameters in a QC file. If the QC program detects a violation of a QC rule, the system logs an error message and displays an error code on the Quality Control screen. Refer to the following charts to interpret QC Error Codes. Note: On the Quality Control screen, if a QC rule is violated, you can view QC error codes two ways: The error code appears in the Cursor area if you are viewing QC data in a Levey Jennings chart format. If you press Display Data, you can also view QC error codes associated with individual data points. QC Error Codes Learn about QC error codes. Control Limit Check Method Westgard Multirule Check Method Code QC Violation Code QC Violation S.U.L. QC analysis result exceeded the Upper Stop Limit. 1-2s One QC result exceeded ±2 SD limit. U.L. QC analysis result exceeded the Upper Flag Limit. 1-3s One QC result exceeded ±3SD limit. L.L. QC analysis result fell below the Lower Flag Limit. 2-2s Two consecutive QC results exceeded ±2SD limit. S.L.L. QC analysis result fell below the Lower Stop Limit. 4-1s Four consecutive QC results exceeded ±1SD limit.     R-4s The difference between this result and the previous QC result exceeded 4 SD limit.     10X Ten consecutive QC results all deviated to the same side of the mean. When complete, select the X in the upper-right corner to close the window and continue. Sysmex® CA-1500 System quality control program features include the following: Easy setup: Three simple tasks: define control plasmas, establish display groups, and set QC rules. Data storage: User-defined QC files store QC analysis data--you can define up to 20 different QC files. Each QC file stores QC results for a specific control plasma and can store up to 540 data points for up to 25 different test parameters. Easy data transfer to implement a new control lot: Linked QC files allow you to compare new QC data to current QC data when you’re evaluating a new control lot number. You can then quickly transfer data when you're ready to implement the new control lot. QC charts. User-defined display groups allow you to view a range of QC results for a test method in a Levey-Jennings QC chart--and you can define which charts to display. Many QC features must be set up by you—the operator. Select Next to continue. Before you can run QC, you must set up the QC program. QC setup involves three simple steps: Define each control plasma using the Reagent Information Setting screen to enter QC parameters, such as ID, lot number, expiration date, and the designated QC file that will store QC results for each control plasma. Define display groups so that you can evaluate QC test results in a Levey-Jennings QC chart format. Run a minimum number of QC samples, and then specify the QC rules that you want the program to use to evaluate QC results: either Control Limit or Westgard Multirule check methods. Note: For each control plasma, you must designate the QC file where you want to store its QC results. All reagents (including control plasmas) are defined using the Reagent Information Setting screen. Control Limits Learn about control limits. The Control Limit check method evaluates if QC results exceed the mean ±2 standard deviations (2SD), or the mean ±3 standard deviations (3SD). If a QC result exceeds a control limit, the system flags the result in red on a Levey-Jennings QC chart, sounds an alarm, and records an error message on the error log as described below: Upper Stop Limit = mean +3SD. If a QC analysis result exceeds the upper stop limit, the instrument stops running, an alarm sounds, and the error log records a QC Exceeds Stop Limit error message. Upper Flag Limit = mean +2SD. If a QC analysis result exceeds the upper flag limit, an alarm sounds and the error log records a QC Flag Limit error message. Lower Flag Limit = mean -2SD. If a QC analysis result falls below the lower flag limit, an alarm sounds and the error log records a QC Flag Limit error message. Lower Stop Limit = mean -3SD. If a QC analysis result falls below the lower stop limit, the instrument stops running, an alarm sounds, and the error log records a QC Exceeds Stop Limit error message. When complete, select the X in the upper-right corner to close the window and continue. Westgard Multirule Learn about westgard multirule check methods. The Westgard Multirule QC check method uses six different control rules to judge the acceptability of an analytical run: 1-2s rule = A single QC result exceeded the mean +/-2 standard deviations. 1-3s rule = A single QC result exceeded the mean +/-3SD. 2-2s rule = Two consecutive QC results exceeded the mean +/-2SD. 4-1s rule = Four consecutive QC results exceeded the mean +/-1SD. R-4s rule = The difference between the current QC result and the previous QC result exceeded 4SD. 10x rule = Ten consecutive QC results fell on the same side of the mean. When complete, select the X in the upper-right corner to close the window and continue. When you run QC, the system stores QC results in QC files. How does the QC program know which QC results to store in which QC file? You must specify a single QC file for EACH control plasma so that the QC program knows where to store each control plasma's results. This is called “defining” the QC file. QC files are defined during QC setup when you define ALL the QC parameters for each control plasma, such as lot number, expiration date, and QC file. QC Files Learn about what is in a QC file.   Control Plasma 1 Example Control Plasma 2 Example QC file defined on Reagent Information Settings screen 1 2 Sample ID entered on worklist QC01 QC02 Tests ordered on worklist PT, aPTT, and Fbg PT, aPTT, and Fbg Check method for PT and aPTT set on QC Settings screen Control Limit Control Limit Check method for Fbg set on QC Settings screen Westgard Multirules Westgard Multirules QC results stored in QC01 and QC02 files PTQC01, aPTTQC01, and FbgQC01 PTQC01, aPTTQC01, and FbgQC01 When complete, select the X in the upper-right corner to close the window and continue. The Sysmex® CA-1500 System QC program allows you to compare new QC data to current QC data when you are evaluating a new control lot number. Each file in the first 10 QC files (QC01-QC10) is linked to its associated file in the last 10 QC files (QC11-QC20): QC01-10 files are designated for current control lots. QC11-20 files are used to accumulate data in order to establish the mean and range of unassayed new control lots. QC01 is linked to QC11, QC02 is linked to QC12, QC03 is linked to QC13, and so forth. Use the QC program's Change Lot feature to transfer data when you're ready to implement a new control lot. Use the QC program's Change Lot feature to transfer data when you're ready to implement a new control lot. Select Next to continue. After running QC, you can view individual QC results on the Stored Data List screen—just as you view patient sample results. But the best way to evaluate QC results is to view a range of QC results in Levey-Jennings charts in display groups on the Quality Control screen. Before you can view QC results in a display group, you must: Run a minimum number of controls so that the QC program has sufficient QC results to display in a QC chart. Define the display group by designating which QC results to display in each group. Each display group that you define—or register—can simultaneously display up to three QC charts from the QC results stored in any defined QC file. You can register up to 160 display groups. Note: Display groups need to be “built” by you. Each display group can hold up to three QC charts. This means that you can designate up to three different sets of QC results per display group. Select Next to continue. Use the Quality Control screen to view individual display groups of up to three QC Levey-Jennings charts per group. A Levey-Jennings chart is defined as a single-rule QC procedure that compares data to control limits that are set to the meant +2 standard deviations (2SD), or the mean +3SD to determine if data should be accepted or rejected. On a Levey-Jennings control chart: The Y-axis displays concentrations centered on the mean value with standard deviations indicating upper and lower acceptability limits. The X-axis displays time or other QC measurement intervals. Evaluating a range of QC results in a Levey-Jennings chart, using a series of QC rules, allows laboratories to interpret individual control results to determine if patient test results can be reported and, if not, what type of errors are occurring in out-of-control runs. Select Next to continue.