Switching Reagent Lots on the Atellica® Solution - A Comprehensive Overview

Continue Continue Continue Continue Main Scene Switching Reagent Lots on the Atellica® Solution – A Comprehensive Overview Day in the Life of the Lab Series Look for more content in our Day in the Life of the Lab Series. Welcome Welcome to Switching Reagent Lots on the Atellica Solution – A Comprehensive Overview. A part of our Day in the Life of the Lab Series. This training is specific for Lab Managers or Key Operators. Recommended to view after Atellica Solution installation. Blank Hello, my name is Samuel, but you can call me Sam. I am an applications specialist and I have responsibility for training customers on comprehensive overview topics for the Atellica Solution. Today, I would like to discuss how reagent comparison is part of your workflow and the features that are available to conduct your patient evaluations to support switching reagent lots. Accreditation Guidelines for New Reagent Lots - Examples ISO – International Organization for Standardization CLSI – Clinical Laboratory and Standards Institute Blank In some labs, there are regulations, such as CLSI or ISO, that when you switch to a new lot, you must run a study. In the Atellica Solution software, Reagent Comparison is a method comparison tool, that can be used to compare the percentage of result differences of a set of patient samples. Your lab selects several samples with concentrations spanning the measuring interval to use in the study. Then, you can compare the reagent you want to put on to the old reagent lot according to the acceptance criteria that your lab has set, as part of its standard operating procedure. Two Ways to Plan You choose the tool: Reagent Overview Screen Assay List Blank Did you know that you don’t have to stop running all patient samples when switching reagent lots? There are two different ways that you can use to plan how your patient samples will be run while you’re doing your reagent lot evaluation. You can choose the tool that makes the most sense for your lab. The first option is using the Reagent Overview screen to disable the lot and the second way is putting the assay into troubleshooting mode by utilizing the assay list. First Way Using the Reagent Overview Screen Note: For chemistry tests, the test definitions are loaded automatically with the new software updates. While for immunoassay tests, you will need to scan the 2D barcode for the new reagent lot. Blank So, let’s begin with our first way using the reagent overview screen to disable the lot. Before beginning a reagent comparison study, you need to confirm that the test definition for the new lot is loaded and calibrate the two reagent lots that are being compared. Please review the attached job aid describing how to scan 2D master curve test definition barcodes for immunoassay tests. Blank After you have scanned in the new lot and loaded the reagent pack, you can see it in the Reagent Overview screen that I am showing. You may ask yourself, “How do I control the system when switching the reagent lots to make sure that my patient samples are not run on the new lot until I am ready?” On the bottom of the screen are two buttons that can be used for this - Disable Reagent Pack and Disable Reagent Lot. For these purposes, we will select the disable the reagent lot button. That makes sure that no patient samples are running from that reagent lot while making the switch. Second Way Using the Assay List Blank Now on to our second way to disable the reagent, which is using the Assay list. Blank The other tool that I was discussing earlier is the Assay list. As an example, your lab may be switching to a new lot of calcium reagent. Did you know that you can stop doing calcium patient tests on an analyzer by selecting calcium as I am showing here and putting it in troubleshooting? In Troubleshooting mode, the assay is conditionally available on the analyzer. The system only sends QC and calibration orders for that assay to the analyzer; no patient orders are automatically sent. However, the operator can manually designate a patient test to process on the Troubleshooting analyzer if needed. Recap – Two Ways to Plan Using the Reagent Overview screen to disable the lot Using the Assay list to put the assay into troubleshooting Blank So, to recap we have a few tools that you can use to make sure patients don’t run on the old lot while you are doing your study. Blank Another thing I’d like to discuss is about another screen that may be useful as you prepare to do a reagent comparison - the Assay Status screen. This screen is a bit different from the Assay List screen we saw earlier. The intended use of the Assay status screen is to answer the question "Why is a test not running?" This screen tells you what is blocking samples from running on an assay on an analyzer. A check mark means the assay is ready to test patients on that analyzer and you can expand the test line for details about each pack or well on each analyzer. This provides a nice summary of the status of all the assays on all the connected analyzers. One More Item to Cover Utilizing the Lot Log Blank So, I have one more item to cover before we talk about the Reagent Comparison tool. Utilizing the Lot Log. After you have scanned in the new lot of reagent, you will see that lot displayed on the Lot Log screen. Let me explain further. Blank Shown here is the Lot Log screen. Did you know that the system automatically tracks when a new lot is introduced to the system for all scanned materials? You can use the lot log to see when a new lot was first started. Note: If the new reagent lot or pack has been Disabled in Reagent Overview, it will have to be Enabled prior to starting the Lab Evaluation testing Blank Ok, now we’re ready to look at the Reagent Comparison tool. You can navigate to the lab evaluations screen by using the blue tile on the home screen, or by using the navigator, to begin to create the reagent comparison study. Did you know that the tiles on the home screen are configurable? You may want to add lab evaluations to your home screen in your own lab, like my customer did, so it is easy to reference when you need it. Blank Let me point out a few things on the Reagent Comparison screens that are important when you are creating a study. For details on all the necessary fields, please refer to the attached job aid. On the first Reagent Comparison screen, you enter the information for your study, the assay, and the specimen type. The candidate reagent is your new lot or the lot that you are evaluating. The current reagent is the one that is approved for use and not being evaluated - it is the one that is being compared to. The reagents could be on the same analyzer, or they could be on different analyzers. Blank The next screen is where you enter the information for your samples. The best practice is to select samples that cover the concentration range when doing a lot evaluation. But it is important to make sure that you follow your laboratories specific procedures. Did you know the study allows you to use the barcodes that are already on the tubes, or you can make new sample IDs if you prefer. Blank The third screen shows you a summary of the information that you’ve ordered. At this point, select the Place Order button. By selecting Place Order, a popup will display for you to print the barcodes, place on the sample tubes and load to the system to start processing the study samples. Blank After the samples complete processing, you can review your results by selecting Details on the Lab Evaluations screen. Note: Wait until all samples are complete before selecting approve. Blank You can see here the range of the samples that we had selected compared to the total measuring interval. Remember we had said earlier that the best practice is to select samples across the full range; here you can see how well you did with that. These statistics displayed are based on the study data, but you should approve in accordance with your lab’s acceptance criteria. After you have approved the study, you can now put that lot into use in your laboratory. For example, you might change the sticker in your inventory or put a note in your refrigerator; whatever is your lab’s protocol for putting a new lot into use. Finally, you can print your reagent comparison study by selecting the print icon that I am showing here. Study Results Are available in a PDF print version. Blank Here is an example of what the printed report looks like. Blank Finally, if you have multiple analyzers, you would do a separate study for each one, and you would see each study listed back on the Lab Evaluations screen. An option is to use the Repeat button - this allows you to use the same study setup and just change the analyzer. Are you ready for a knowledge check? Knowledge Check You have just learned about Switching Reagent Lots on the Atellica® Solution – A Comprehensive Overview. Select Start to test your knowledge of the presented content. Start Knowledge Check Select the best answer. Knowledge Check On which screen, can you see which assays are ready to use on each analyzer and what is blocking samples for each assay on an analyzer? Assay Status Assay List Reagent Comparison Multiple Choice Reagent comparisons are performed by the laboratory to compare the results of a set of patient samples using variables of analyzer, lot or reagent pack. It may be to meet accreditation requirements or to troubleshoot assay issues. Assay list screen allows you to enable or display assays on the system, on individual assays on individual analyzers for each specimen type or set assays on individual analyzers. Knowledge Check Completion Review Retry Retry Continue Continue You have just completed the Knowledge Check. Select Review to assess how your responses compare to the correct answers. Select Retry to test your knowledge again or select Continue to advance through the course. Knowledge Check Completion Refer to Online Help and PEPconnect for more information! Blank Thank you for taking the time to learn more about switching reagent lots on the Atellica Solution. For a refresher on the steps I have covered, use the Resources link in the upper right corner of the screen to access job aids on this topic. For more information you can search by specific keywords on Online Help, or check out PEPconnect, where you have access to additional job aids and videos. I look forward to spending another day in the life of the lab with you very soon and sharing more information about the Atellica Solution. Disclaimer 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. © Siemens Healthcare GmbH 2023 Siemens Healthineers Headquarters\Siemens Healthcare GmbH\Henkestr. 127\ 91052 Erlangen, Germany\Telephone: +49 9131 84-0\siemens-healthineers.com Disclaimer Exit A part of the Day in the Life of the Lab Series You have completed Switching Reagent Lots on the Atellica® Solution – A Comprehensive Overview Completion Question Bank 1 QR700000223 | Effective Date: 11-SEP-2023 AS_Reagent Comparison Job Aid AS_Lot Log Job Aid Scanning MC TDEF Barcodes on the AS Job Aid AS_Assay List Job Aid AS_Assay Status Job Aid Reviewing Reagent Inventory on the AS Job Aid Atellica® Solution Lab Evaluations Job Aid