Starting a New Lot of QC Workflow on the Atellica® Solution

Continue Continue Main Scene Starting a New Lot of QC Workflow on the Atellica® Solution 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 the Starting a New Lot of QC Workflow on the Atellica® Solution. A part of our day in the life of the lab series. This advanced training topic is intended for operators who already have a basic understanding of the system. A worldwide reference for Implementation of New Lots of QC can be found in the “CLSI C24 A4 Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions; Approved Guideline Blank Hi, it’s me Sandy. I am an experienced user and I have responsibility for training others in my lab on the Atellica Solution. One of the new hires recently asked me why some of the more senior technicians in our lab or even myself, often are tasked to start the new lots of QC in our lab? I am going to show you how I train people in my lab on the proper procedure so we can continue to process samples efficiently. I like to make sure everyone uses the same steps. Where I begin…. First I create my definition with the usage set to parallel. Blank So, starting a new lot of QC really comes down to workflow. By following the steps that I use, and the resource information available on my Atellica Solution in Online Help, I have all the tools I need to start a new lot of QC. First, I create my definition with my usage set to parallel. Let me explain this concept further. Blank I have navigated to the QC definitions screen that I am showing here. To begin to create my definition with parallel usage, I begin by selecting add new. Blank Then as I fill in the control details, I make sure that the usage is on parallel. I then select the test, fill in the appropriate level details and then I select save. Did you know? Parallel control results generate observed ranges. Blank Let me just pause for a second and ask the following question. Did you know that if you have the QC definition set to parallel, the control results will generate observed ranges? It is important to note that they do not generate violations or flags for test evaluations. Let’s continue with our next step. Next Step Order QC Parallel Study using the lab evaluation suite. Blank Next, I order the QC Parallel Study from the lab evaluation suite. Let me show you how I do that when I am training others. The Lab Evaluation Tile can also be found by using the Navigator. Blank I navigate to the Lab Evaluations Tile which in my lab is located on the second page of my dashboard. This tile location maybe different in your lab. As you know the dashboard is customizable. This study is to help your lab perform real time parallel testing automatically. Blank Then I select QC Parallel, and then the Next Button to begin to create my QC Parallel Comparison Study Evaluation. Please note that this study is to help your lab perform real time parallel testing automatically. It is not completed at one time but goes over a period of time set by my lab in the following screens that I will be showing. The study configures the analyzer to run the candidate lot, every time any operator in my lab orders on the current lot. For Sample Handler configurations, it is especially useful to store both the control lots in the Cal-QC Storage Area. Blank Now on this screen we configure the QC material by creating the name of the evaluation. Then select the current and candidate lot. The current QC lot is the one that is approved for use and not being evaluated - it is the one that is being compared to. The candidate QC lot is your new lot or the lot that you are evaluating. Then choose how this evaluation will stop – you can select to stop the study after a set number of points or after a set date. After entering all the information, select next. Blank Then I select the specific assays that I want to use in this evaluation and then I select next. Blank The third screen shows you a summary of the information. At this point, select the Place Order Button to create the orders for the current lot. Then select Print Barcodes to print the sample barcodes if needed. The corresponding orders for the candidate lot will be created once there is a result for the current lot. Next Step Review the summary and the QC parallel evaluations. Blank My next step includes reviewing the summary and the QC parallel evaluations. I would consider this one of the most important steps when starting the new lot of QC. Blank After the samples complete processing, you can review your results by selecting details on the Lab Evaluations screen. For information on determining observed ranges for a lab with multiple Atellica Solution configurations, refer to attached Managing a New Lot of QC Job Aid. Blank From here I can reject or approve this evaluation. For purposes of this workflow explanation, I will approve the study. Approving means that these results are acceptable by my laboratories standard operating procedures. It is important to review your own lab’s procedures. My next step is to evaluate target values and then implement new targets and ranges. Blank To update the target control ranges with the observed ranges from your analyzer, on the QC Definition screen, you select the appropriate definition and then select Edit/View. Blank Then I select the appropriate check boxes for levels and test names and select the Observed Ranges Button where I can edit my target range for my new QC definition. If there is more than one analyzer for a control population, the Observed Range data is the mean of all data points run on that control population. Blank Now I am on this QC Observed Ranges screen and I can choose the check box for the control range I want and then select copy. Then I select primary for my primary analyzer, and then save. Our Final Steps After Evaluating the New Lot Change old QC lot to "Not In Use" Update QC Scheduler In QC Statistics Tools, archive the old QC lot data To further expand your “QC Knowledge” check out “Maintaining QC Targets and Using Calibration Effectively” on PEPconnect under General Laboratory. Blank Our final steps include editing the QC definition for the old lot of QC to make sure that the usage is set to not in use. Also, if your lab uses automatic QC scheduling like mine does, make sure to remove the automatic ordering of the lot that was set to not in use, and then you need to confirm that the old QC lot data has been archived. My lab does this automatically because of the schedule we have defined in database maintenance. One final note - if your lab imports new QC definitions, the same process can be used. The usage can be changed to 'Parallel' after the QC file is imported and once the study is complete, observed ranges can be used for the QC definition. That’s it! Are you ready for a knowledge check? Knowledge Check You have just learned about Starting a New Lot of QC Workflow on the Atellica® Solution. Select Start to test your knowledge of the presented content. Start Knowledge Check Select the best answer. Parallel Question 1 of 1 While a new lot of QC is being evaluated, it is recommended to set the usage for its QC definition to which of the following? Alternate Not in Use Multiple Choice The usage should be set to Not in Use when the control lot is expired. The usage should be set to Alternate when an alternate control lot for additional QC flagging and statistical data is needed. 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 starting a new lot of QC 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 Starting a New Lot of QC Workflow on the Atellica® Solution Completion Question Bank 1 QR700000796 | Effective Date: 09-OCT-2023 Creating QC Definitions on the Atellica® Solution Job Aid Creating QC Panels on the Atellica® Solution Job AId Exporting and Importing QC Definitions on the Atellica® Solution Job Aid Exporting QC Data on the Atellica® Solution Job Aid Atellica® Solution Managing a New Lot of QC Job Aid Atellica® Solution Lab Evaluations Job Aid