Dimension® EXL™ with LM Integrated Chemistry System QCC Online Training

Activate Calibration Auto Acceptance Parameters (CAAP) Configure QC and Calibration Alerts Define and View QC Products and Panels Define Calibration Products Define QC Status and Ranges Group Calibration and QC Alerts Retrieve and Store Calibration Data Welcome to the QCC PowerPak® course for the Dimension® EXL™ with LM integrated chemstry system. After completing this course, you will be able to: Select Next to continue. Quality Control (QC) alerts allow more efficient quality control operation. Configuring this function provides the means to set up alerts which will notify you when QC is out of specified conditions. Configuring QC Alerts Learn how to configure the QC Alert. Instructions:If media does not automatically start, select the play arrow to begin.Flash File:/content/generator/Course_90002893/simEXLConfigQCAlerts_9/simEXLConfigQCAlerts_9.swfHTML5 File:/content/generator/Course_90002893/simEXLConfigQCAlerts_9/index.htmlPDF File: The QC Status screen allows you to define the hourly intervals for performing quality control. Configure a QC Status List Learn how to set up a QC status list. Instructions:If media does not automatically start, select the play arrow to begin.Flash File:/content/generator/Course_90002893/simEXLDefineQCStatus_9/simEXLDefineQCStatus_9.swfHTML5 File:/content/generator/Course_90002893/simEXLDefineQCStatus_9/index.htmlPDF File: It is important to enter and maintain current QC ranges for each method to use QC alerts and calibration auto acceptance. Ranges for 2 levels of QC must be defined in the system to use the QC Alert and calibration auto-acceptance features. Defining QC Ranges Learn how to Define QC Ranges. Instructions:If media does not automatically start, select the play arrow to begin.Flash File:/content/generator/Course_90002893/simEXLDefineQCRanges___9(2)/simEXLDefineQCRanges___9(2).swfHTML5 File:/content/generator/Course_90002893/simEXLDefineQCRanges___9(2)/index.htmlPDF File: The Dimension® EXL™ with LM integrated chemistry system can hold up to 100 QC products. Once the QC is defined, you can assign up to 36 methods to be run for each product. This function also notifies the system which QC will be run to validate a calibration as well as which QC will be run on the daily QC. Defining QC Products Learn how to define QC Products. Instructions:If media does not automatically start, select the play arrow to begin.Flash File:/content/generator/Course_90002893/DEFINE QC PRODUCTS_demo__9/DEFINE QC PRODUCTS_demo__9.swfHTML5 File:/content/generator/Course_90002893/DEFINE QC PRODUCTS_demo__9/index.htmlPDF File: The Define QC Panels screen provides the means to match a barcode ID to a panel of tests requiring QC on a periodic basis.  You can define up to 50 QC panels with 36 tests in each panel. Tests cannot be added to a QC Panel after it is created.  Tests first must be added to the QC Product and then loaded into the Panel. Defining QC Panels Learn how to Define QC Panels Instructions:If media does not automatically start, select the play arrow to begin.Flash File:/content/generator/Course_90002893/DefineQCPanels_9/DefineQCPanels_9.swfHTML5 File:/content/generator/Course_90002893/DefineQCPanels_9/index.htmlPDF File: The Define Calibration Products screen allows you to scan or enter up to 150 calibration product definitions including the product name, lot number, expiration date, and bottle values for each method. Defining Calibration Products Learn how to Define Calibration Products Instructions:If media does not automatically start, select the play arrow to begin.Flash File:/content/generator/Course_90002893/DEFINING CAL PRODUCT_demo_9/DEFINING CAL PRODUCT_demo_9.swfHTML5 File:/content/generator/Course_90002893/DEFINING CAL PRODUCT_demo_9/index.htmlPDF File: Calibration alerts are configured to notify you when a calibration is needed on the system. Configuring Calibration Alerts Learn how to configure Calibration Alerts Instructions:If media does not automatically start, select the play arrow to begin.Flash File:/content/generator/Course_90002893/configCalAlerts_9/7 TAKE 1_demo_9.swfHTML5 File:/content/generator/Course_90002893/configCalAlerts_9/index.htmlPDF File: To activate Auto Acceptance of calibrations and verifications, the Auto-Accept screen requires that each method must be selected, parameters must be reviewed, and approver’s name must be entered. Setting up Auto Acceptance Learn how to set up Auto Acceptance. Instructions:If media does not automatically start, select the play arrow to begin.Flash File:/content/generator/Course_90002893/simEXLCAAP_9/simEXLCAAP_9.swfHTML5 File:/content/generator/Course_90002893/simEXLCAAP_9/index.htmlPDF File: Grouping calibration alerts enables the operator to set up calibration for multiple methods within a defined calibration product from one screen. Grouping calibrations that have common calibrator products reduces preparation time and saves time for the operator. Grouping QC Alerts enables the Operator to set up repeat QC for multiple methods within a defined QC Product from one screen. Grouping Calibration Alerts Learn how to group Calibration Alerts Checklist TitleChecklist TypeChecklist ContentGroup Calibration AlertsHTMLSelect each checkbox to learn more about how to group Calibration alerts. Operating MenuHTML From the Operating Menu, select Calibration Alert.Calibration AlertHTML From the Calibration Alert screen, select F3: Group Cals.Group Calibration AlertsHTML Move the cursor to the group to be set up. Select F2: Setup Group.Setup GroupsHTML After selecting the desired Calibration Product, press F1: Select Product. When the message "Confirm the lot # is correct" appears on screen type Y for Yes and then press Enter.Load ListHTML The Group Calibration screen redisplays with the calibration lot selected. Complete the Operator and starting cup position fields, and then use the F8: QC Yes/No key to indicate if QC should be run. Next, select F4: Assign Cups to schedule the calibration. Then select F7: Load/Run to display the load list.Run CalibrationHTML When the Load List screen displays, load the calibration and QC onto the system and select F4: Run. When methods have been set up with Auto Acceptance, the instrument automatically will calculate and accept calibrations if the QC has passed and the auto acceptance specification for that method are met. A calibration report will be generated automatically. Note:  If performing verification, the system will not calculate.Calibration ReviewHTML If a calibration or verification does not auto accept, a calibration alert will be generated and auto accept will be displayed in the alert column. From the Calibration Alert screen, select F2: Calib Review to display the Calibration Review screen.Accept/Reject DataHTML The Calibration Review screen is used to review calibration run data. Data that meets specifications is displayed in green and data outside specified limits are displayed in red. Use F2: Accept Data or F8: Reject Data. Select the X in the upper-right corner to close the window and continue. Grouping QC Alerts Learn how to group QC Alerts Checklist TitleChecklist TypeChecklist ContentGroup QC AlertsHTMLSelect each checkbox to learn more about how to group QC alerts. Operating Menu ScreenHTML From the Operating Menu screen, select QC Alert.QC Tests Out of Range ScreenHTML Select F6: Group Alerts.QC Groups ScreenHTML Methods that are out of QC range are grouped by QC product and will display the needed volume of QC Material. Use F1 to assign a sample ID and then select F5 to load 1 QC product or F6 to load all QC Products. From the load list screen, select RUN to process the controls after moving the QC sample to a new location. Select the X in the upper-right corner to close the window and continue. The Calibration History function provides the operator with a way to view and print data from previous calibrations.  The screen resembles the calibration review screen.  Information from Calibration History also is provided in the Store Laboratory Data feature of QCC PowerPak® software.   Calibration History Features The system starts archiving data once QCC PowerPak® software is installed. QC values that were obtained with calibration are displayed at the press of a key. The initials of the operators who performed and  accepted the calibration data are recorded. The software stores approximately 70 calibrations per method or 5 years of calibration data.   Store Laboratory Data Features: QC and test data can be stored for approximately 100,000 QC and 100,000 Test results. Information is stored in file format that is compatible with Microsoft® Excel and can be transferred using the included USB memory stick. Note: You may only upload one category of data at a time. Retrieving Calibration Data Learn how to retrieve laboratory data. Instructions:If media does not automatically start, select the play arrow to begin.Flash File:/content/generator/Course_90002893/RET CAL HISTORY_demo_9/RET CAL HISTORY_demo_9.swfHTML5 File:/content/generator/Course_90002893/RET CAL HISTORY_demo_9/index.htmlPDF File: Storing Laboratory Data Learn how to store laboratory data. Instructions:If media does not automatically start, select the play arrow to begin.Flash File:/content/generator/Course_90002893/STORE_Lab_DATA_demo_2_9/STORE_Lab_DATA_demo_2_9.swfHTML5 File:/content/generator/Course_90002893/STORE_Lab_DATA_demo_2_9/index.htmlPDF File: Congratulations. You have completed the QCC PowerPak® course for the Dimension® EXL™ with LM integrated chemistry system. Listed below are the key points that have been presented.  Take time to review the material before you proceed to the final quiz.  Configure QC Alerts The QC Alert feature allows more efficient quality control operation.  Configuring this function provides the means to setup alerts which will notify you when QC is out of specified conditions. To configure QC Alerts, select the Alert button on the Operating Menu, press F4: Config Alert then turn on the alerts required for your facility.   Define QC Status The QC Status screen allows you to define the hourly intervals for performing quality control. Access the Quality Control Status List screen from the Operating Menu by pressing F5: Process Control then F3: QC Status. Define QC Range  It is important to enter and maintain current QC ranges for each method to use QC Alerts and calibration auto acceptance.Calibration auto acceptance requires that at least two QC levels be run with the calibration. To define QC ranges, start at the Operating Menu and press F5: Process Control then F4: QC Ranges. Use the method keys to select a method and set the mean and SD values. Press F2: Store Changes to save these values. Define QC Products     The Define QC Products function allows you to create a database for QC products. When a QC product is setup, the following parameters are defined: Product name Product level Lot number QC Fluid level (Serum QC 1-3 and Urine QC 1-2) Fluid Type (Serum, Plasma, Urine, CSF/Blood) Active or Inactive to be used with daily QC and/or calibration Tests to be run with this QC product With this feature configured, you can assign up to 36 methods to a single QC product and store up to 100 QC Product definitions. Once a QC Product has been defined, additional QC Product levels can be defined easily by modifying the parameter settings.  QC Product definitions can be edited or deleted using the Edit QC Products screen.  The QC product definitions will be used later to define QC Panels. To define QC Products:    Select QC Alert key F5: Define QC Products Input QC Product Information Select Methods F5: Set QC Active F6: Set CAL active F7: Store Edit to define additional levels F1: New Product Define QC Panels The Define QC Panels function is used to assign a unique sample ID barcode to a group of tests loaded from a previously defined QC Product. This allows the operator to create up to 50 QC Panels with up to 36 methods in each. . To define QC Panels: F5: Process Control F3: QC Status F6: Define QC Panels F6: Load from Product F1: Select Product Delete tests as needed F5: Assign Sample ID F7: Store F1: New Panel Define Calibration Products The Define Calibration Products function is used to scan in calibrator specific information such as the Product name, lot number, expiration date, units and bottle values.  The hand held bar code scanner scans the 2D bar code on the calibration product Instruction for Use (IFU) sheet. Bar code scanning eliminates the need to manually input calibrator values and reduces calibrator information transcription errors. The Dimension® EXL™ with LM stores up to 150 Calibrator Products, which are deleted through the Edit Calibration Product screen.  To define Calibration Products: Select Calibration Alert key F5: Define Cal Product Scan Product Information F7: Store Configure Calibration Alerts The purpose of Calibration Alerts is to notify the user if a calibration is needed or will expire in a set amount of time on the Dimension® instrument. Calibration Alerts are generated when a Flex® reagent cartridge is put into inventory but is not calibrated, when calibration is expired or when a calibration is about to expire (1-240 hours in advance.) To configure Calibration alerts: Select Calibration Alert key F4: Configure Alerts Turn on the alerts required by your facility Activate Calibration Auto Acceptance Parameters (CAAP) Calibration Auto Acceptance standardizes acceptance criteria eliminating the need for manual review for most methods. Patients can be run at the same time when a method is being re-calibrated. When the QCC PowerPak®software is activated, the Auto Acceptance parameters must be reviewed with the laboratory, edited if necessary, and accepted for use by the laboratory. Auto Acceptance Default Parameters are used to determine if a calibration is acceptable. Acceptance requires that QC range values are defined on the system and that a minimum of 2 QC levels are run as part of the calibration.   When setting up Auto Acceptance, default parameters are displayed on the screen. Operators can edit the default acceptance criteria to customize the parameters. Auto acceptance parameters (default or customized) require laboratory approval.  To activate auto acceptance, the auto-accept screen requires that each method be selected, parameters reviewed and approver’s name entered. To activate Calibration Auto Acceptance: F5: Process Control F1: Calibration Enter Password F4: Auto Acceptance Select Method View/accept/edit Auto Acceptance Criteria F4: CAAP On F7: Store Group Calibration and QC Alerts The Group Calibrations function is used to set up calibration runs for groups of methods that use common calibrator products to maximize reagent usage and reduce tech preparation time. Grouping Calibrations reduces operator setup steps for calibration. Operators can group methods using a common calibrator material, define calibration products, select a specific calibrator lot from a pick list, and run the maximum number of methods using the minimum number of cups. When QC is run with calibrations, QC products are automatically selected from the list of defined QC products. To group Calibration alerts: Select Calibration Alert key F3: Group Cals F2: Setup Group F1: Select Product Enter Operator’s initials Assign Start at Position F8: QC Yes No F4: Assign Cups F7: Load/Run F4:Run To group QC Alerts: Select QC Alert key F6: Group Alerts Use F2 to delete a method or the test keys to add a method F1: Assign Sample ID F5 or F6 to load one or all Retrieve and Store Data   The Calibration History function provides the user with a way to view and print data from previous calibrations.  The screen resembles the calibration review screen.  Calibration history is archived once QCC PowerPak® is installed. It records the QC values that were obtained with calibration, the initials of the operator who performed the calibration, and the operator who accepted the calibration data. The database can store approximately 70 calibrations per method or up to 5 years. Information from calibration history also is provided in the Store Laboratory Data feature. Test data can be stored for approximately 100,000 QC results and 100,000 test results. All stored information is compatible with Microsoft® Excel and can be transferred using the USB memory stick. To retrieve Calibration History data:   F5: Process Control F1: Calibration Enter Password/Press Enter F7: Calib History Press method key Navigate history (F1: Previous or F2: Next) To store Calibration data: F5: Process control F8: More Options F7: Store Lab Data F7: Calib ON/OFF Press F2 to change date range Once the range is set, F1: Store Data Select Next to continue.     During panel processing, the LabPro System uses a standard database of organisms that contains biotypes for frequently identified organisms.  If the LabPro System can't find the biochemical reaction pattern or the biotype for a certain panel, a Very Rare Biotype or Low Probability ID exception is generated. The Biotype Lookup tool can be used to help troubleshoot these types of exceptions.  This feature uses an extended database that extends the cut off that defines the organisms in the standard database and includes biotypes for organisms that are not identified as frequently. Quality Control and Calibration (QCC PowerPak® ) software is a software enhancement package that automates the calibration and quality control setup and review process. Laboratory data can be stored on a flash drive for transfer to another computer. Select the image area highlighted below to see the location of the USB port.