Atellica® Solution Setting Up An Assay Online Training

Continue Continue Continue Untitled Scene Master Template HILS2218 | Effective Date: 25 Mar 2022 Atellica® Solution Setting Up An Assay Online Training How to prepare for, and add, a new assay to the Atellica Solution. Welcome Welcome to the Atellica Solution Setting Up An Assay Online Training. This online training will help prepare you for adding, or replacing, a new assay onto your Atellica Solution. Setting Up An Assay Online Training Refer to the Atellica® Solution Operator’s Guide and Online Help for more information about setting up an assay. Course Conclusion This concludes the Setting Up An Assay Online Training. If you would like more information on setting up a new assay, don’t forget to refer to the Atellica Solution Operator’s Guide and Online Help. Disclaimer Exit Course Please note that the learning material is for training purposes only. For the proper use of the software or hardware, please always use the Operator Manual or Instructions for Use (hereinafter collectively “Operator Manual”) issued by Siemens Healthineers. This material is to be used as training material only and shall by no means substitute the Operator Manual. Any material used in this training will not be updated on a regular basis and does not necessarily reflect the latest version of the software and hardware available at the time of the training. The Operator Manual shall be used as your main reference, in particular for relevant safety information like warnings and cautions. Please note: Some functions shown in this material are optional and might not be part of your system. Certain products, product related claims or functionalities (hereinafter collectively “Functionality”) may not (yet) be commercially available in your country. Due to regulatory requirements, the future availability of said Functionalities in any specific country is not guaranteed. Please contact your local Siemens Healthineers sales representative for the most current information. The reproduction, transmission or distribution of this training or its contents is not permitted without express written authority. Offenders will be liable for damages. All names and data of patients, parameters and configuration dependent designations are fictional and examples only. All rights, including rights created by patent grant or registration of a utility model or design, are reserved. Unrestricted | Published by Siemens Healthineers AG | © Siemens Healthineers AG, 2024 Siemens Healthineers HQ | Siemens Healthineers AG Siemensstr. 3 91301 Forchheim Germany Phone: +49 9191 18-0 siemens-healthineers.com Disclaimer Atellica® Solution Setting Up An Assay Online Training Items to order Assay Setup Guided Workflow Managing test reporting Preparing for assay performance verification Resources on Siemens Document Library Course Introduction This training will cover the following topics: items to order to prepare for adding an assay to your system, preparing for assay performance verification, managing test reporting, resources on Siemens Document Library, and lastly, a walk-through of the Assay Setup Guided Workflow. Things to Consider Before Adding a New Assay… When adding a new assay to the Atellica® Solution, there are many tasks to complete and decisions to make. Always keep in mind to follow your local accreditation requirements before putting a new assay into use for patient testing. Select the numbered steps below to learn more. 1 1 1 2 2 2 3 3 3 4 4 4 Things to Consider Base Layer: When adding a new assay to the Atellica Solution, there are many tasks to complete and decisions to make. Always keep in mind to follow your local accreditation requirements before putting a new assay into use for patient testing. Select the numbered steps below to learn more. Item 1 Layer: Before you begin integrating an assay on your analyzer, you will need to order the necessary supplies. Confirm with your representative or Siemens Healthineers representative, if the new assay’s necessary material has been added to your account or contract. Refer to the new assay’s Instructions for Use (IFU), which is found on Siemens Document library, for a list of the required and optional materials and their respective part numbers. The ordering process may vary by country or customer. Some items you will need to order include reagents for the assay you’re adding, depending on the assay, this includes primary and ancillary reagents, pre-treatment solutions, and sample diluents. Other items to order include calibrators and QC material, calibration verification or linearity material, and other materials such as proficiency testing samples or patient samples that cover the assay measuring range. Keep in mind which assay verification studies are required for your lab and which materials will be needed to perform the studies on your system. And don’t forget to refer to the assay Instructions for Use to see what materials are recommended by Siemens Healthineers for your system. Item 2 Layer: Another thing to think about when adding a new assay is Assay Performance Verification. There are many tasks involved in assay performance verification and always keep in mind the requirements needed based on your lab’s inspection agencies. Some tasks to prepare for include: Repeatability (precision), Reference Range Verification, Carry Over Study for the CH module only, Accuracy, Method Comparison, Calibration Verifications, and establishing QC ranges. Prior to starting method validation, make sure you have all the supplies needed to complete the studies such as Reagent, QC and Calibration material, and samples for method comparison that cover the assay measuring interval. Note that the Atellica software does have corresponding Lab Evaluations to assist in completing some of these tasks, such as the Automatic and Manual Measuring Interval Verification Studies, and the Simple Precision Studies. Item 3 Layer: When adding a new assay, it is also important to think about patient test reporting. How will the test results be reported? What units will be used? How many decimal points will be reported? Is this a qualitative or quantitative test? Will the test be diluted? Repeated? Will there be critical values? In addition to the patient test report, you will also need to think about how the test will be reported from the analyzer. Test coding will need to be added as well as updating middleware, such as ADM and the LIS. Item 4 Layer: There are some additional things to consider such as writing or updating SOPs, obtaining safety data sheets, and writing physician letters. Siemens Document Library has many resources that can be used to help you out. For example, on Document Library for each assay you can find Safety Data Sheets, the assay IFU, which is the Instructions for Use, and to help you write your SOPs, you can find the assay CLSI procedures which can be downloaded as a Word document and edited into your lab’s SOP format. Lastly, don’t forget about sending letters to physicians letting them know a new assay will be added to your lab menu, or updating them with new test ranges. Select the X in the upper right corner to continue the training. Document Library Resources and Physician Letters 4 Document Library Resources Safety Data Sheets Assay Instruction for Use (IFU) CLSI procedure to help write laboratory Standard Operating Procedures (SOPs) Physician Letters Send letters to physicians with new/updated assay and new test ranges. Managing Test Reporting 3 What units will be used? How many decimal points? Qualitative or quantitative? Dilutions? Repeats? Critical values? Test coding Updating middleware (ADM) Updating LIS Repeatability (Precision) Reference Range Verification Carry Over Study for the CH module only Accuracy Method Comparison Calibration Verification (Linearity or Measuring Interval Verification) Establishing QC ranges Assay Performance Verification 2 Items to Order 1 Calibrators and QC Material Calibration Verification Material Proficiency Testing Samples Patient Samples Covering the Assay Measuring Range CH Reagents IM Reagents Linearity Material Assay Setup Guided Workflow Assay Setup Guided Workflow Once you have all your materials collected and necessary assay information, you are ready to configure the new assay on the system. When setting up a new assay in the Atellica Solution software, the Assay Setup Guided Workflow can be used to guide you through the steps. Note that you will need log in privilege's to make changes to your system. The Assay Setup guided workflow can be accessed on the home page by either selecting the Navigator button at the bottom left of the screen, or by selecting the Guided Workflows button in the Tools section, if it has been configured to show on your homepage. Select Next to move through the Guided Workflow steps. Assay Setup Guided Workflow On the left side of the Guided Workflows screen, notice that there are various Guided Workflows that can be used to assist you in different tasks that you might perform. Guided workflows allow the operator to complete a multistep process without navigating to multiple windows. To begin the assay setup, you’ll first select the workflow titled, “Assay Setup”. Next, on the right side of the screen, you’ll select Launch. Assay Setup Guided Workflow Select the test type to add or edit an assay. You can either select CH or IM to view or edit assay configurations. Notice that here you also have the option to manage operator defined assays. Note that operator defined assays are unique to the CH module only, and does not apply to the IM module. Assay Setup Guided Workflow If IM is selected, you have the option to View or Edit an assay, or scan a Master Curve and Test Definition Barcode. Let’s choose the option to Scan Master Curve and Test Definition Barcode and see what happens. Notice that it gives us instructions to scan the 2D barcodes on the Master Curve and Test Definition. Let’s return to the previous step and move forward with the option to View or Edit an IM Assay. Assay Setup Guided Workflow After selecting IM, then View/Edit, select Next at the bottom of the box. Assay Setup Guided Workflow Here you will select an assay. An assay will turn orange when selected. At the bottom of the screen, you will select OK to proceed. Assay Setup Guided Workflow On the left side of the Assay Setup screen, you can see that the guided workflow will walk you through 8 steps to get an assay setup on your system. You can complete 1 or multiple parts of the guided workflow, exit the guided workflow at any point, save or discard changes, and save pending changes during the workflow by selecting Save, if available. Additionally, you can minimize the guided workflow into the tray if you need to navigate to do another task and then return to the workflow by expanding the window from the bottom tray. Should you want to learn more about the fields on this page, you can select the help button, which is indicated by a question mark, for further information. The first task to complete is editing the Test Definition. In the Definition screen, review the assay information and measuring intervals, and modify as appropriate. Note that some sections have scroll bars that will need to be selected and moved to see all of the information. In this example, when the Assay Identification section is scrolled, you will see more informations such as the LIS Code. Let’s move on to the Calculation section next. Assay Setup Guided Workflow In the Calculation section, you can modify information such as the units of the assay, correlation factors, and HIL alert indices. The Calibration section is next. Assay Setup Guided Workflow In the Calibration section, you can modify calibration details for the assay. To point out a few features on this screen, on the right side of the screen, you will see the calibration replicates information, the calibration interval, and onboard stability information. Let’s look at the reagents section next. Assay Setup Guided Workflow In the reagents section, you will find information regarding the reagents that are required for the assay. Note that there is information for primary, ancillary, and diluent reagents. Assay Setup Guided Workflow The lot section provides information for any Test Definition card that has been scanned into the system for the selected assay, including lots that are expired. The most recent lot scanned in is listed at the top. Assay Setup Guided Workflow The Ranges section provides access to the available range configuration tabs for the assay. The tabs are located at the top of the page and can be selected to view or make changes. For example, in the Reference tab, you will define values for critical low, low, normal, high, and critical high ranges for the selected assay. For each range, you can select flags and actions that the system should automatically follow when a result falls within that range. Assay Setup Guided Workflow In the Repeat section, the repeat conditions that will cause an operation to repeat will be determined. Notice the many types of flags that are listed in the Flags column. Assay Setup Guided Workflow Next you will move on to the Panels section. Here you will add dilution panels and test panels. To add a new Dilution Panel or Test Panel, select the buttons at the top of the screen. To display and edit the details of a selected panel, select a panel from the list, and then select the Edit/View button on the right side of the screen. Assay Setup Guided Workflow The next section is where Off-System Tests can be added or edited. Off-System Tests enable the laboratory to add tests that the system does not perform. For example, to calculate a RBC folate, the operator must enter the Hematocrit from a Hematology system. Another example would be to include a manually performed test such as ionized calcium with PTH. Select the Add New button to add a new test, and from there, you will enter the Test Identification information, Calculation values, and either enable or disable the test. Assay Setup Guided Workflow In the next section, Ratios can be added or edited. Ratios are formulas used to calculate a result using results of other tests. For instance, you can setup a BUN and creatinine ratio calculation to be included in patient results. The Add New button at the top of the screen is where new Ratios are created. To edit or view a ratio, select one from the list, and then select the Edit/View button on the right side of the screen. Assay Setup Guided Workflow In the next section, Reagent Thresholds are configured. Here you can configure system alert settings when reagent inventory falls below a threshold configured. Notice that alerts can be set for both primary and ancillary reagents. Assay Setup Guided Workflow In the next section, which is the Assay List, you can specify which specimen types are supported on an analyzer, change the state of an assay to Enabled, Disabled, or Troubleshooting, and configure the Assay Priority. You can keep the assay in Troubleshooting mode until you are ready to go live with the new assay for patient testing. Assay Setup Guided Workflow In the Test Display Order section, you can customize the order that assays display. The test order displays in any assay list for creating patient orders, QC order entry, any assay list in Worklist, and printed lab results reports. To change the order, select a single test and then use the arrows on the right side of the screen to move the position up or down. Groups of tests can also be selected. Assay Setup Guided Workflow To modify a QC Panel, the last section is used. To add a new QC Panel, select Add QC Panel and enter the information. A panel can be edited by selecting a QC Panel from the list, and then selecting the Edit/View button on the right side of the screen. Note that QC product must be defined for a test before it can be built into a QC panel. This concludes the overview of the Assay Setup Guided Workflow. Outside of the Assay Setup Guided Workflow, there are some other things that might need to be setup or edited in the Atellica Solution software when preparing for adding a new assay, such as updating the QC Scheduler and creating or editing sort groups in the Sample Handler. Assay Setup Guided Workflow If you use the QC Scheduler to schedule QC testing to perform automatically, don’t forget to update or add the new assay to the QC Scheduler. QC can be performed by day and time, by test count, or by control material, so choose the tab on the top of the screen that corresponds to the type of schedule you would like to setup. Assay Setup Guided Workflow Another thing to think about is creating or editing sort groups in your Sample Handler for the new assay. For instance, if you are adding HCV and would like reactive results to be sorted out so they can easily be removed for confirmation testing. To setup or edit the configuration for your Sample Handler sorting, from the Navigator, in the General Setup section, select SH & Sorting Configuration. Here you can see there are multiple sections where you can configure the Sample Handler. As related to Assay Setup, make sure to view the Test Sort Groups section, and the Sample Workflow section. assay setup olt