Atellica® Solution Reagent Lot Comparison Job Aid Version 1.25 and Below

SIEMENS Healthineers Atellica® Solution Reagent Lot Comparison Job Aid Template Effective Date: 27-MAY-2019 | HOOD05162003010284 Effective Date: 5-JUL-2020 | HOOD05162003103183 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® Solution SIEMENS Healthineers Reagent Lot Comparison The Reagent Lot Comparison feature in the Atellica Solution software is a method comparison tool. Before using a new reagent lot for sample testing, the Reagent Lot Comparison feature can be used to compare results from two different lots of reagent. • The laboratory processes a number of samples with concentrations spanning the measuring interval using both lots • The operator compares the new reagent to the old reagent lot according to their laboratory's acceptance criteria This tool can also be used to perform a variety of other studies, including: • Compare 2 reagent packs within a lot to troubleshoot assay issues • Compare 2 reagent packs across analyzers (for example, same lot of Chol on 2 CH analyzers to determine instrument differences) 2 Effective Date: 5-JUL-2020 | HOOD05162003103183 Unrestricted © Siemens Healthineers, 2020 Atellica® Solution SIEMENS Healthineers Reagent Lot Comparison To evaluate a new lot of reagent (quantitative assay type): 98 Pafest Debers 1. Confirm the test definition for the new lot is loaded Fest - • For the Atellica® CH Analyzers, the test definitions are Mvaried loaded automatically with new software updates Test Display Order --- line Delaas CA125 For Atellica® IM Analyzers, scan the MC TDEF 2D barcode Open Channel • CAT Spornen Type Suis A Poll Sort Teil Dufinalum CKA LIS Cade Wp for the new reagent lot. For more information, refer to LONC these resources: o Online Help: Scanning IM Master Curves and Assay Test Definitions 2D Barcodes - --------- -- y o PEPconnect: Scanning MC TDEF Barcodes on the Atellica® IM Analyzer Video 3 Effective Date: 5-JUL-2020 | HOOD05162003103183 Unrestricted © Siemens Healthineers, 2020 Atellica® Solution SIEMENS Healthineers Reagent Lot Comparison 2. Load and calibrate the 2 reagent lots 98 Spam Sarcies inventory Patent Ordin Before calibrating the new lot, consider how you will Reagent Overview Rangent Lander Rangent Meets Supplies Overview Reagent Let Comparison • LA0010 configure the system to ensure that patient samples will Reagents Reagent Details not be run on the new lot during the evaluation. Options Inventory Sequence Calibration Calibration Cal Type In QC Interval Lot Cal Eligibility 000166 6718 for this include: 001030 Pack IM Magent compartment Position 150 001051 Park Count o Disable the new lot until you’re ready to do the 625/2015 11 :00:00 AM 30421. 01-4000 Pan OBS Calibration Expiration 1/2/2018 12:01 :06 PM comparison study: Inventory > Reagent Overview 20 921 014061 Pack Status Caltrate Lot Caltrate Pack 56 622% o Put the assay into troubleshooting mode. This allows 16 8 23 6 1d 10h Let you to run studies but the system will not run patients O 03-4706 29 d 22 h on the assay: Setup > Test Definition > Assay List 000229 16 d 22 h 14.10 ml 50 0 14 001099 o Take the whole analyzer off line after running the study Group by magere Disable Heagent Pack Double Reagent Lot calibrations: System > Status > analyzer 4 Effective Date: 5-JUL-2020 | HOOD05162003103183 Unrestricted © Siemens Healthineers, 2020 Atellica® Solution SIEMENS Healthineers Reagent Lot Comparison 3. Configure the Run ID Settings Ban A A System Samples Inventory Calibration Patient Orders Worklist Maintenance Setup B Create Patient Orders Create Batch Order by Rack Create Batch Orders by SID Edit Multiple Orders View Batch Orders A. On the Command bar, select Patient Orders Sample Information Test Selections Enter test names, separated by commas. Sample ID Module Type Select Tests B. Select Create Patient Orders ack ID Orders Specimen X Test Run ID Settings X Manual Dilution C. Select Run ID Settings For Study D Run ID Priority Routin Settings D. Enter a Run ID STAT ASAP Use Run ID in all orders Additional Sample Information >> E Patient Demographics Confirm Run ID on Create Patient Orders tab E. In the Settings area, select Use Run ID in all Orders and Patient ID Confirm Run ID on Create Patient Orders tab Use Run ID for imported worklists only First Middle O Do not use Run ID in any orders F. Select OK Last DOB MM/DD/YYYY 15 F Sex ? OK Cance Location Additional Patient Information C Print Barcode .. Show or Hide Fields Run ID Settings ... Save Clear NOTE: Run IDs must be 0–32 alphanumeric characters with no separators or special characters. The Run ID becomes the study name in Reagent Lot Comparison. 5 Effective Date: 5-JUL-2020 | HOOD05162003103183 Unrestricted © Siemens Healthineers, 2020 Atellica® Solution SIEMENS Healthineers Reagent Lot Comparison Create Patient Orders * Create Batch Order by Rack Create Batch Orders by SID Edit Multiple Orders View Batch Orders 4. Create the orders on the first Sample ID for both reagent lots ID Sample Information Test Selections B Enter test names, separated by commas. Sample ID Sample 123 Module Type CH Select Tests A. On the Create Patient Orders screen, in the Sample A ack ID Orders Information section, enter the Sample ID and Specimen Specimen Serum X Test Dilution Replicates / System Test Options/ Manual Dilution + X GluH_3 x1(Undiluted) Edit Test Options 1 type For Study + X GluH_3 x1(Undiluted) Priority Routine To apply a “For Study” flag to the results, select For STAT System Test Options X • ASAP Test Name GluH_3 Study Additional Sample Information > Analyzer CH Patient Demographics 2 Lot B. In the Test Selection area, select the tests Patient ID 110000 Primary Pack First C. Use the + button to add another test order Middle Last D. Select the appropriate lot for each test order DOB MM/DD/YYYY 15 Sex 1) Select Edit Test Order Location Additional Patient Information ? Clear All OK Cancel E 2) In System Test Options, select the appropriate lot Save Clear 3) Select OK NOTE: Be sure the reagents used for this study are enabled. E. Select Save to create the test orders F. Repeat the steps to order tests on additional samples NOTE: The For Study flag can be used to hold results from being transmitted to the LIS by using General Setup > Patient configuration settings or middleware settings. 6 Effective Date: 5-JUL-2020 | HOOD05162003103183 Unrestricted © Siemens Healthineers, 2020 Atellica® Solution SIEMENS Healthineers Reagent Lot Comparison 5. Ensure additional orders do not become part of the study Run ID Settings X A. On the Create Patient Orders screen, select Run ID Settings Run ID B. In the Settings area, select Do not use Run ID in any orders Settings C. Select OK Use Run ID in all orders Confirm Run ID on Create Patient Orders tab 6. Load and run the samples O Use Run ID for imported worklists only B C Do not use Run ID in any orders ? C OK Cancel 7 Effective Date: 5-JUL-2020 | HOOD05162003103183 Unrestricted © Siemens Healthineers, 2020 Atellica® Solution SIEMENS Healthineers Reagent Lot Comparison 4. Review the results A B Rangent Overview Reagent Leader Supplies Overvien Auagent Let Comparison Cal-00 Storage Inventory A. On the Command bar, select Inventory C Select Study humor?ct Export E D Tust LOL B - 200964 B. Select Reagent Lot Comparison UM_ UNA C. From the Select Study Name drop-down menu, select UN 50 59 7800 4 2104 the Run ID UNLS 19-3104 36 D. View a plot of the data in the Plot tab • The equation of the line and R2 value are displayed below the graph LOA- 200885 E. Select the Export button to create an export of the Reagent Lot Comparison Report 8 Effective Date: 5-JUL-2020 | HOOD05162003103183 Unrestricted © Siemens Healthineers, 2020 Atellica® Solution SIEMENS Healthineers Reagent Lot Comparison Detailed Data Export Another option for exporting the results is to use the Worklist Overview screen to Export Test Results × create an export that contains only the the data with all of the details for the results Patient Orders (pack ID, calibration information, etc). Hide Patient Name and ID Navigate to Worklist > Worklist Overview, then select Export. In the Export Test Control Orders Results window, be sure to select the Select Run ID checkbox. Select Run ID 1555 For more information, refer to these resources: Order Date Range Select date range. • Online Help: Exporting Results From 9/ 6/2017 G- 10:06 AM • PEPconnect: Function Options in the Worklist Overview Screen on the To 9/ 7/2017 0- 10:06 AM Atellica® Solution Video ? Export Cancel 9 Effective Date: 5-JUL-2020 | HOOD05162003103183 Unrestricted © Siemens Healthineers, 2020 SIEMENS Healthineers 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's Manual shall be used as your main reference, in particular for relevant safety information like warnings and cautions. 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. Atellica, and all associated marks are trademarks of Siemens Healthcare Diagnostics Inc. or its affiliates. All other trademarks and brands are the property of their respective owners. Product availability may vary from country to country and is subject to varying regulatory requirements. Please contact your local representative for availability. Copyright © Siemens Healthcare GmbH 2020 Siemens Healthineers Headquarters Siemens Healthcare GmbH Henkestr. 127 91052 Erlangen, Germany Telephone: +49 9131 84-0 siemens.com/healthineers 10 Effective Date: 5-JUL-2020 | HOOD05162003103183 Unrestricted © Siemens Healthineers, 2020