Sysmex® CA-500 Series System Quality Control Online Training

Welcome to the Sysmex® CA-500 series Quality Control online training course. Running quality control ensures reliable data and allows you to monitor instrument and reagent system conditions to prevent inaccurate results from being reported. The Sysmex® CA-500 series coagulation analyzer has an onboard quality control package that allows you to easily analyze control plasma and statistically manage QC results. Note: This course does not include audio. Upon successful completion of this course, you will be able to: Describe features of the QC program including data storage and evaluation Identify key features of the Quality Control screen Demonstrate how to print QC data from the Quality Control screen and identify data on QC printouts This course does not include audio. Congratulations. You have completed the Sysmex® CA-500 Series Quality Control 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 QC program, including data storage and evaluation. The QC program provides six different QC files. Each QC file stores analysis results for a specific control plasma. Each QC file can store up to 180 data points for up to 14 different test methods. You can evaluate stored QC data for a test method in a Levey-Jennings QC chart which plots a range of QC data around the mean QC value ±2 and ±3 standard deviations. The QC program evaluates each data point and flags data that violate control limits set for each QC file. Identify key features of the Quality Control screen. From the Main Menu screen, press QC to open the Quality Control screen. Select the test method and QC file that you want to view. Note the following features displayed on the Quality Control screen: QC file and test method Control plasma lot number and expiration date Mean, standard deviation, coefficient of variation, and number of data points QC analysis results displayed in a Levey-Jennings chart format. The Cursor area displays the analysis result for a selected data point in the QC chart. Change Scale key to change the scale of the QC chart Settings key to define the QC file based on the needs of your laboratory Select Test key to select the test method you want to view Print key to print QC data in a list or graph format Demonstrate how to print QC data from the Quality Control screen and identify data on QC printouts. From the Main Menu screen, press QC to open the Quality Control screen. Select the test method and QC file that you want to view. On the Quality Control screen, press the Print key and then do the following: Press Graph to print QC results in a Levey-Jennings chart format. Press List to print QC results in a list format. Press Cancel to cancel printing and return to the Quality Control screen. Use the Quality Control screen to view and evaluate a range of QC results in a Levey-Jennings chart. To view QC data: From the Main Menu screen, press QC to open the Quality Control screen. On the Quality Control screen, If the test method for which you want to view QC results appears, press Select File to open the Select File screen. If the test method for which you want to view QC results does not appear, press Select Test. On the test menu that appears, select the test method to open the Select File screen. On the Select File screen, select the QC file for which you want to view QC results. The Quality Control screen appears with a Levey-Jennings chart that displays QC results for the selected QC file and test method. Press Main Menu to return to the Main Menu screen Quality Control Screen Learn about key features on the Quality Control screen. Checklist TitleChecklist TypeChecklist ContentQC KeyHTML From the Main Menu screen, press the QC key. File No. FieldHTML On the Quality Control screen that appears, the File No. field indicates the QC file and test method for the QC results displayed on the screen. For example, this screen shows that you are viewing PT control plasma analysis results that are stored in QC01. Lot No. FieldHTML The Lot No. field indicates the control plasma lot number defined for this QC file. Exp. FieldHTML The Exp. field indicates the control plasma expiration date defined for this QC file. Statistical DataHTML This area displays statistical data about the QC results displayed in the QC chart: the mean, standard deviation, coefficient of variation, and number of data points. Cursor AreaHTML The Cursor area displays the analysis result for a data point in the QC chart. This area also displays the date and time that the analysis took place. The movable cursor in the QC chart is positioned over the data point whose results appear in the Cursor area above. Use the Left or Right arrow keys to select another data point in the QC chart. This feature allows you to find the QC results for a particular day. QC Analysis ResultsHTML This area displays a range of QC analysis results for the selected QC file and test method in a Levey-Jennings chart format. Two and three standard deviations above and below the mean QC value indicate the upper and lower acceptability limits for the QC data collected. On the screen shown here, the Y axis displays PT clotting times centered on the mean clotting time value. The X axis displays the date range over which the QC results were collected. Control LimitsHTML This area displays the control limits defined for the QC results stored in this QC file. Control limits are rules that the QC program uses to evaluate the QC data collected. Change ScaleHTML Use the Change Scale key to change the scale of the QC chart you are viewing. You can display a maximum of either 60 or 180 data points per chart. Quality Control Screen Example View an example using QC Screen features. Checklist TitleChecklist TypeChecklist ContentSelect Settings KeyHTML Press the Settings key. View QC File SettingsHTML The Settings key opens the Quality Control Settings screen, where you can view the settings that define this QC file. The Quality Control Settings screen is used to set up each QC file based on the needs of your laboratory. Press the Return key to return to the Quality Control screen. Select Test KeyHTML Press the Select Test key. If the test method for which you want to view QC results already appears, press the Select File key. Select APTT KeyHTML On the test menu screen that appears, press the APTT key. Select QC03 KeyHTML The Select File screen appears. The Select File screen displays a key for each of the QC program’s six QC files. Each key indicates the date of the last analysis. Files without dates do not contain any stored QC data for the selected test method. In this example, we'll view the APTT results by pressing the QC03 key. Select Test KeyHTML The Quality Control screen displays APTT results for the control plasma defined for QC03. To view the QC01 results for fibrinogen, press the Select Test key. If the test method for which you want to view QC results already appears, press the Select File key instead. Select Fbg KeyHTML On the test menu that appears, press the Fbg key. Select QC01 KeyHTML The Select File screen always appears after a test on the test menu screen is selected. In this example, the QC01 key is selected. View Fbg ResultsHTML The Quality Control screen displays fibrinogen results for the control plasma defined for QC01. Select Print KeyHTML The Print key allows you to print QC data in a list or graph format. Use the Quality Control screen to print QC results in a Levey-Jennings chart or list format.  To print QC results: From the Main Menu screen, press QC The Quality Control screen appears On the Quality Control screen, use the Select File / Select Test keys to select the test method and QC file that you want to print Press Print On the print setting screen, do the following: Press Graph to print QC results in a Levey-Jennings chart format. Press List to print QC results in a list format. Press Cancel to cancel printing and return to the Quality Control screen. Print Quality Control Data Learn how to print QC Data. Checklist TitleChecklist TypeChecklist ContentSelect QC KeyHTML From the Main Menu screen, press the QC key. Select Print KeyHTML  PT control plasma analysis results that are stored in QC01 are displayed on the Quality Control screen. To output the graph, press the Print key. Select Graph KeyHTML On the Print Setting screen, press the Graph key. Printer Outputs GraphHTML The following screen appears while the printer outputs the graph. View Graph PrintoutHTML The graphical printout displays the same data that you learned to identify on the Quality Control screen: (1) Test method & QC file; (2) Control Plasma Lot No. & Exp. Date; (3) QC Data Points; (4) Control Limits; (5) QC Statistics. Select List KeyHTML Let’s look at this same data in a list format. On the Print Setting screen, press the List key. View List PrintoutHTML Each data point that you viewed in the Levey Jennings chart appears in a list format that includes the analysis date, time, and result: (1) Test method & QC file; (2) Control Plasma Lot No. & Exp. Date; (3) QC Data Points; (4) Control Limits; (5) QC Statistics. The Sysmex® CA-500 series coagulation analyzer quality control program includes the following features: Data storage: QC files store QC analysis data. The QC program provides six different QC files. Each QC file stores analysis results for a specific control plasma. Each QC file can store up to 180 data points for up to 14 different test methods.  QC evaluation: You can evaluate stored QC data for a test method in a Levey-Jennings QC chart which plots a range of QC data around the mean QC value ±2 and ±3 standard deviations. The QC program evaluates each data point and flags data that violate control limits set for each QC file. Your Technical Application Specialist (TAS) will work with your laboratory to set up your QC program by defining each QC file. For each QC file, the TAS must specify the control plasma reagent to run, the test methods to store results for, and the control limit settings to evaluate QC results. Control Limit Settings Learn about control limit settings. Control Limit Settings Control limits evaluate 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 on a Levey-Jennings QC chart, as described below. Code QC Violation Stop_UL Upper Stop Limit = mean +3SD. If a QC analysis result exceeds the upper stop limit, the instrument stops running. Flag_UL Upper Flag Limit = mean +2SD. If a QC analysis result exceeds the upper flag limit, the instrument flags the data as an error. Flag_LL Lower Flag Limit = mean -2SD. If a QC analysis result falls below the lower flag limit, the instrument flags the data as an error. Stop_LL Lower Stop Limit = mean -3SD. If a QC analysis result falls below the lower stop limit, the instrument stops running.