syngo® Lab Data Manager Investigate Quality Control Online Training

Upon successful completion of this course, you will be able to: Define the two main tools used to implement Whiteboard value selling Describe the components of each tool Explain the process for building a Whiteboard Select Next to continue. Welcome to the syngo® Lab Data Manager Investigate Quality Control Online Training course.  Statistical quality control procedures monitor analytical performance of assays and alert analysts to problems. Investigating problems will assist you in deciding if there is a valid concern that affects patient results or if there is an issue with the control product. This decision determines whether patient results should be accepted or discarded and rerun which can have a significant negative impact on expense, labor, and turn around time. With the syngo Lab Data Manager Quality Control application, there are several features that facilitate quality control investigation and allow appropriate actions to be performed on quality control results. Select Next to continue.   Demonstrate actions on Controls and results Evaluate quality control using patient results Examine QC errors by comparing related Controls Recognize and respond to QC alerts Upon successful completion of this course, you will be able to: Select Next to continue. Welcome to the Sales Excellence Challenge Overview Assessment.  This assessment will test your knowledge of the material presented in the Sales Excellence Challenge Introduction module.  Select Next to continue. Congratulations.  You have completed the syngo Lab Data Manager Investigate QC 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.  Demonstrate actions that can be performed on Controls and results Confirm a QC result Process – from Controls Details select the result > Confirm > enter a comment > Save Maintains the value in the statistics Maintains the value in the Levey-Jennings graph Removes the error condition from the data point Exclude a QC result Process – from Controls Details select the result > Exclude > enter a comment > Save Changes the QC status to X Removes the value from the Control statistics Removes the error condition from the data point Excludes the data point from the lines of the graph Exclude multiple QC results Process – from the Unresolved QC screen > select multiple results > Resolve > enter a comment > Exclude Excludes all values with one process and one comment entry Used most often when controls are poured incorrectly Removes the error condition from the data points Update a target Process – from Controls Details select Calculate Target > OK > Save > enter comment > Save When manually activating a Control When the Control displays a shift when the shift is not due to an assay problem When the QC material product insert value was used as the initial target value When the instrument sends a qualitative (Pos, Neg) result for the Control Close a Control Process – from Controls list select Control checkbox> Close > OK Changes the QC status to Closed and accepts no further QC results When no longer using the control product When no longer running that assay or instrument When product was renamed in the instrument and new Controls were created   Examine QC errors by comparing related controls Compare Controls Process – from Controls list select Controls checkboxes > Compare Controls displayed on same L-J chart using Z scores Next Control Process – from Controls Details select Next Control Next Control button toggles between the companion Controls Review Related Controls Process – from Controls Details select Review Related Controls > select criteria for matching instrument, product, level, lot, or assay > Go Allows review of all Controls that meet the criteria    Use patient results to evaluate quality control Patient Review Process – from Controls Details select Patient Review > enter date range and limits > Review Details Displays patient daily median in L-J chart format Patient Statistics Configured one time and always processing data Displays consolidate patient results per data point in L-J format QC rules can apply    Recognize and respond to QC alerts Unresolved QC Alerts Have a variety of causes as shown in the descriptions Select the row to open Controls Details screen where actions can be performed to resolve the alert – Confirm, Exclude, Save a target, etc. QC Unassigned Results Caused by expiration of a control product or insufficient information to add it to a Control or create a new Control Process – from Unassigned > select the row > Exclude > enter comment > Save QC Ready Controls Control has satisfied the evaluation criteria and waiting to be made active Process – from Ready select the row > Calculate Target > OK > Save > enter comment > Save Select Next to continue.   Market trends are the movement of financial markets over time.  Understanding market trends will give you insight into the unique needs, pressures, and expectations of a diverse customer base and the entire global market.  In this section, we will discuss the Hematology market trends in developed countries, emerging countries and healthcare globally.  Select the link below to learn more about the Healthcare Industry Market Trends. During the investigation of a QC error it is helpful to view and compare related Controls to see if they follow the same trend. This additional information could assist you in differentiating an issue with the control product from an assay problem or instrument concern. The syngo Lab Data Manager Quality Control application offers the following options to review and compare related Controls: Compare Controls Next Control Review Related Controls   Compare Controls Learn how to compare controls. Instructions:If media does not automatically start, select the play arrow to begin.Flash File:/content/generator/Course_90004634/sim_sLDM_CompareCtrl_800x600_9/sim_sLDM_CompareCtrl_800x600_9.swfHTML5 File:/content/generator/Course_90004634/sim_sLDM_CompareCtrl_800x600_9/index.htmlPDF File: Next Control Feature Learn about the next control feature. Instructions:If media does not automatically start, select the play arrow to begin.Flash File:/content/generator/Course_90004634/sim_sLDM_NextCtrl_800x600_9/sim_sLDM_NextCtrl_800x600_9.swfHTML5 File:/content/generator/Course_90004634/sim_sLDM_NextCtrl_800x600_9/index.htmlPDF File: Review Related Controls Learn how to review related controls. Instructions:If media does not automatically start, select the play arrow to begin.Flash File:/content/generator/Course_90004634/sim_sLDM_ReviewRelated_800x600_9/sim_sLDM_ReviewRelated_800x600_9.swfHTML5 File:/content/generator/Course_90004634/sim_sLDM_ReviewRelated_800x600_9/index.htmlPDF File: The Hematology Market is segmented by the size of the facilities and numbers of tests they run per year, and is important to the point of Healthcare delivery. It is an integral piece of most physician care decisions and part of the Core Laboratory approach to testing.  Each type of customer has common, yet specific needs. As the size of the facility increases, so do the customer's specific needs. In the US, the development of ACOs is leading to a highly competitive landscape as various facilities are wanting inclusion in these ACOs (Accountable Care Organizations). An ACO is a group of doctors, hospitals, and other health care providers, who come together voluntarily to give coordinated high quality care to their Medicare patients. This results in the formation of Disease Specific Certification Programs and the desire to have the newest technology for innovation purposes to give facilities a competitive edge.    Select Next to continue. In today's lab it is common practice to run QC only once a day or once a shift.  If there is a shift or trend in the QC it is useful to determine if the patient results are also displaying the same bias. In the syngo Lab Data Manager Quality Control application evaluating QC using patient results can be performed by the following two methods. Patient Review Patient Statistics   Patient Review Learn how to run a Patient Review. Slide NumberText BlocksCalloutsAudio ScriptImage File1Patient Review In this exercise we will use the Patient Review feature to determine if the patient results are trending in the same way as the Glucose Controls. Select the Patient Review button.   Note: If audio does not automatically start, select the play arrow in the top left to begin.In this exercise we are investigating the QC for Glucose because both levels of controls are trending high. To see if the patient results are being affected in the same manner we will run a Patient Review. Let's start by selecting the Patient Review button.2Patient Review In the Patient Review screen we want to define the criteria for the analysis. The date range defines the days of data that should be included in the review. Select the calendar icon next to the Begin date field and select 12/15/2010.  In the Patient Review screen we will enter the beginning and ending dates for the review and also specify the limits for the data that we want included in the analysis. For this exercise we will use a date range of 12/15/2010 to 12/31/2010. Select the calendar icon next to the Begin date field and select 12/15/2010. 3Patient Review Select the calendar icon next to the End date field and select 12/31/2010.  Select the calendar icon next to the End date field and select 12/31/2010. 4Patient Review The low and high limits define the data to include in the analysis. We will use limits that are slightly above and below the reference range for Glucose so we have chosen 70 for the Low value and 111 for the High value. Now that the criteria have been entered we are ready to run the analysis. Select Review Details. Now we want to enter the appropriate limits that define the range of the data that should be included in the review. We'll use limits that are a little outside the upper and lower limits of the reference range for the Glucose assay. We have entered 70 for the Low value and 111 for the High value which represent 5% below and above the reference range. Now that the criteria have been entered we are ready to run the analysis. Select Review Details.5Patient Review The Method Review displays a Levey-Jennings graph with a summary in the upper right corner. Each point on the graph represents the daily median for all patient results included in the limits for this assay. Now you can easily review the data for trends or shifts in patient results as compared with Controls. When complete, select the X in the upper-right corner to close the window and continue.The Method Review displays a Levey-Jennings graph with a summary in the upper right corner. Each point on the graph represents the daily median for all patient results included in the limits for this assay. Now you can easily review the data for trends or shifts in patient results as compared with Controls. Patient Statistics Learn about Patient Statistics. Patient Statistics Patient Statistics is a feature that allows for the ongoing review of patient results displayed in a Levey-Jennings graph. This patient based QC is typically performed on a select number of assays. Each assay is configured one time for Patient Statistics. The data is processing constantly so Levey-Jennings graphs can be reviewed and compared to QC anytime. Also QC rules can be applied to patient statistics so you will know when there has been a rule violation in patient results.  The Controls Details screen for patient based QC is designed like that of a typical Control.  The primary difference is that each point on the graph represents the consolidation of a specified number of patient results rather than a QC result. When complete, select the X in the upper-right corner to close the window and continue.     As part of investigating quality control you will evaluate QC results, manage exceptions, and perform actions on QC failures and Controls. Actions on Controls and Results Learn to confirm and exclude results, update a new target for and close a Control. Select each tab below to learn more about confirming results, excluding results, updating a new target for a Control, and closing a Control.TitleTextConfirm a QC resultTab TitleTextDescription A QC Alert is created when a QC result fails a quality control rule that has been defined in the application. When investigating a QC rule failure you have an opportunity to perform an action on the result and document the justification for that action.  One of these actions is to confirm the result.  Confirming a result: Changes the QC status to C Maintains the value in the Control statistics Maintains the value in the Levey-Jennings graph Removes the error condition from the data point Confirm a QC result: Navigate to Controls & Results > Alerts > Unresolved QC Alerts Select the desired alert Select Confirm, enter a comment, and then select Save Exclude a QC resultTab TitleTextDescription Excluding a result from the statistics is acceptable when you have a valid reason for doing so and you document the justification.  Excluding a QC result: Changes the QC status to X Removes the value from the Control statistics Removes the error condition from the data point, changing the color from red to white Excludes the data point from the lines of the graph Exclude a QC result: Navigate to Controls & Results > Alerts > Unresolved QC Alerts Select the desired alert Select Exclude, enter a comment, and then select Save Select OK at the prompt Exclude multiple QC resultsTab TitleTextDescription Excluding multiple QC results can be used when the control products have been poured into the wrong sample cups and all results are associated with the wrong Controls. The quickest solution for this issue is to: Navigate to Controls & Results > Alerts > Unresolved QC Alerts Select multiple results Exclude all with one comment entry Rerun QC in the correct cups Update a TargetTab TitleTextDescription When would you want to save a new target for a Control? When you are manually activating a Control When the Control displays a shift and the change is not due to an assay problem When the QC product insert value was used as the initial target value When the instrument sends a qualitative (Pos, Neg) result for the Control To update targets using current statistical data: Select Calculate Targets in the Target Information of the Control Details screen Select OK at the prompt Select Save Close a ControlTab TitleTextDescription A Control with a status of Closed does not accept new QC results, but is available for viewing, reporting, and exporting until it is archived. A Control can be closed automatically based on configuration settings that define the parameters of the Control. A Control might be manually closed for several reasons: No longer using the control product No longer running that assay or instrument Product was renamed in the instrument and new Controls were created Select the Control(s) you want to close, then select Close. When complete, select the X in the upper-right corner to close the window and continue. When alerts or warnings exist, the Alerts button in all applications displays in orange.  It is possible to see both the type and the number of alerts by moving the cursor over the Alerts button. QC related alerts include Unresolved QC Alerts, QC Unassigned Results, and QC Ready Controls. Select each tab to learn how to respond to the QC alerts. QC Alerts Learn more about the QC Alerts. Tab TitleTextUnresolved QC Alerts Unresolved QC Alerts Example 1 Description: Result could not be added to Control as the lot is expired Resolution: Exclude the result Example 2 Description: Result is non-numeric Resolution: Define the target to be non-numeric (e.g. Neg or Pos) and confirm the result Example 3 Description: Rule failure Resolution: Confirm or Exclude the result QC Unassigned Results QC Unassigned Results Description: A QC result was not added to the Control because: The control product is expired and the option to "mark results as unassigned if lot is expired" is selected There is insufficient information to identify the appropriate Control There is insufficient information to create a new Control. Resolution: Delete All or Exclude    QC Ready Controls QC Ready Controls Description: There is a Control that has satisfied the requirements for the evaluation period and it needs to be made active. Resolution: To make the Control active select the row and save the target in the Controls Details screen.      When complete, select the X in the upper-right corner to close the window and continue. The Quality Control feature has been removed from Version VA12C. If your system is operating with Version VA12C, then the following is in effect:   All access to QC features have been removed QC will continue to upload to the LIS even when QC screens are disabled QC rules for holding patient results will no longer function For further information, refer to the “syngo Lab Data Manager and syngo Lab Process Manager Version VA12C Release Notes” or contact your local Siemens support. Select Next to continue.