Managing QC Lot Crossovers on the Atellica® Solution Job Aid Version 1.25 and Below

SIEMENS Healthineers Atellica® Solution Managing QC Lot Crossovers Job Aid Template Effective Date: 27-MAY-2019 | HOOD05162003010284 Effective Date: 5-JUL-2020 | HOOD05162003102168 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® Solution SIEMENS Managing QC Lot Crossovers Healthineers Workflow for Managing QC Lot Crossovers – Creating QC Definition for the New Lot The following workflow steps can be used to manage QC lot crossovers. The bullets under each step include information on the software screen used to perform that task, and resources for the task that can be found in Online Help and PEPconnect. The resources have the step by step instructions on completing the tasks. 1. Create a definition for the new lot of QC, with the Usage set to Parallel • Software Screen: QC > QC Definition • Resources Available in Online Help: Manually Adding QC Definitions or Importing QC Definitions from XML Files • Resources Available in PEPconnect: Creating QC Definitions Video or Exporting and Importing QC Definitions Video NOTE: Parallel control results generate observed ranges, but do not generate violations or flags for test evaluations. Add New QC Definition Control Details Control Name QC1 Control Lot 12345 Control ID QC1 Control Lot Expiration 11/30/2016 15 Control Type Routine Level 1 Usage Primary Primary Store Onboard Alternate Parallel Tests Not In Use 2 Effective Date: 5-JUL-2020 | HOOD05162003102168 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® Solution SIEMENS Managing QC Lot Crossovers Healthineers Creating QC Orders 2. Create orders and process samples for the new QC lot, for a period of time determined by the laboratory’s Standard Operating Procedure • Software Screen: QC > Create QC Orders or QC > QC Panels • Resources Available in Online Help: Creating QC Orders or Editing QC Panels • Resources Available in PEPconnect: Manually Ordering QC Tests Video or Creating and Ordering QC Panels Video NOTE: It is recommended to use Automatic QC Scheduling with QC Panels, add and remove QC lots to the QC panel for the process of parallel testing. This way you do not need to adjust the schedule for each material on the QC Scheduler screen. System Samples Inventory Calibration QC Patient Orders Worklist Create QC Orders Control Bracketing QC Statistics Patient QC Flagging QC Definitions QC Panels QC Scheduler Filter ... Status: All Panel Name Panel Status Next Expiration Date Date Last Modified DailyQCCH In Use 2/29/2020 11/27/2017 DAILYQCIM In Use 9/30/2019 11/27/2017 3 Effective Date: 5-JUL-2020 | HOOD05162003102168 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® Solution SIEMENS Managing QC Lot Crossovers Healthineers Reviewing QC Results 3. Review QC results and statistics System Samples Inventory Calibration Qc Patient Orders Worklist Maintenance • Software Screen: QC > QC Statistics Create QC Orders Control Bracketing QC Statistics Patient QC Flagging QC Definitions QC Panels QC Scheduler Resources Available in Online Help: Reviewing Review Analysi Messages Tools Setup • 1/16/2020 11:07 AM - 2/12/2020 9:08 PM QC Results and Statistics Filter ... Chart QC Patient Resources Available in PEPconnect: View QC . Alc_E(%), DIABETES 1, Level: 1, Lot#: 55721, Analyzer SN CM00426, Analyzer Name CM00426 • A1c_E(%), DIABETES 1, Level: 1, Lot#: 55721, Analyzer SN CM00427, Analyzer Name CM00426 Statistics Video 35 NOTE: Data from the current lot and the parallel lot can be 25 displayed as an overlay chart on the QC Statistics > Analysis 1S screen. When viewing the charts for multiple QC data files, Mean select the Z-score display option and the Overlay checkbox to overlay the charts. -25 35 1/17/2020 1/18/2020 1/19/2020 /20/2020 1/21/2026 1/22/2020 1/23/2020 1/24/2020 1/25/2020 1/26/2020 1/27/2020 1/28/2020 1/29/2020 1/30/2020 /31/2020 2/1/2020 2/2/2020 2/3/2020 2/4/2020 2/5/2020 2/6/2020 2/7/2020 2/8/2020 2/9/2020 2/10/2020 2/11/2020 R Display: Z-score overlay Scale: This examples shows an overlay chart of the same QC lot on 2 different analyzers. 4 Effective Date: 5-JUL-2020 | HOOD05162003102168 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® Solution SIEMENS Managing QC Lot Crossovers Healthineers Generating Analyzer Specific Target Values 4. When the parallel study results are acceptable, as determined by the laboratory’s Standard Operating Procedure, you can implement the observed means. To set the target ranges to match the current observed ranges for the new QC definition, select the Observed Ranges button on the Edit QC Definition screen. On the QC Observed Ranges screen, select the test(s) and then select Copy. Set the Usage to Primary • Software Screen: QC > QC Definition • Resources Available in Online Help: Using Observed Ranges • Resources Available in PEPconnect: Creating QC Definitions Video (there is information on editing QC definitions towards the end of the video) Edit QC Definition Control Details QC Observed Ranges X NOTE: The Observed Ranges data provides the lab x Control Nam Control Details specific compiled mean for the QC population which is Control Name Assayed Chem Control Level 1 Control Lot 14491 Copy Control I defined. If there is more than one analyzer for a control Ley Test Name Module Name Observed Results SD - Low High Mean (Observed) +/- Range population, it is the mean of all data points run on that Acet CC-05 O Tests Alb P CC-05 control population. CL ALP CC-05 2 85.976 110.204 98.09 12.114 Clear All Ranges ALT CC-05 12 28.562 36.938 32.75 4 188 NA Observed Ranges AST CC-05 13 37.805 53. 133 45 769 7.964 N AAT Ca CC-05 12 2 8.332 8.884 8.608 0.276 *For information on determining observed ranges for a lab Alb_G Chol CC-05 14 2 232.875 242.695 237.785 4.91 ALP CL CC-05 with multiple Atellica Solution configurations, see the next 6 96.707 98.359 97.533 0.826 N ALTP5P Crea CC-05 14 2.242 2.702 2.472 0.23 slide N D_Bil CC-05 Amp300 GGT CC-05 8 48.395 58.855 53.625 5.23 N Amy GIU_ CC-05 10 82.9 88.3 85.6 2.7 N APOB Iron CC-05 0 ? 5 ? Cancel Effective Date: 5-JUL-2020 | HOOD05162003102168 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® Solution SIEMENS Managing QC Lot Crossovers Healthineers Generating Lab Specific Target Values To determine observed ranges for a lab with multiple Atellica Solution configurations, acquire the QC export file from each Atellica Solution, determine the multi system mean and range offline, and enter that mean and range information into the QC Definition screen. After entering the information into one Atellica Solution configuration, you can export the definition and then import it into all the other configurations. Set the QC definition Usage to Primary • Export the QC files by navigating to QC > QC Statistics > Tools > Export > QC • Resources Available in Online Help: Exporting QC Files • Resources Available in PEPconnect: Exporting QC Data Video • Export and import the QC definitions by navigating to QC > QC Definition • Resources Available in Online Help: Exporting QC Definitions and Importing QC Definitions from Atellica Solution Configurations • Resources Available in PEPconnect: Exporting and Importing QC Definitions Video 6 Effective Date: 5-JUL-2020 | HOOD05162003102168 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® Solution SIEMENS Managing QC Lot Crossovers Healthineers Editing the QC Definition for the Old Lot and Adjusting the QC Schedule 5. Edit the QC definition for the old lot of QC to set the Usage to Not in Use • Software Screen: QC > QC Definition • Resources Available in Online Help: Editing QC Definitions • Resources Available in PEPconnect: Creating QC Definitions Video (there is information on editing QC definitions towards the end of the video) 6. If using Automatic QC Scheduling, adjust the QC schedule to remove the automatic ordering of the lot that was set to Not in Use. This can be done by removing the Not in Use QC lot from the QC panel • Software Screen: QC > QC Panels • Resources Available in Online Help: Editing QC Panels • Resources Available in PEPconnect: Creating and Ordering QC Panels Video 7 Effective Date: 5-JUL-2020 | HOOD05162003102168 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® Solution SIEMENS Managing QC Lot Crossovers Healthineers Archiving the Old QC Lot Data 7. The old QC lot data will be automatically archived based on the schedule that has been defined for Database Maintenance • Software Screen: Maintenance > Schedule • Resources Available in Online Help: About Maintenance Database Backup • Resources Available in PEPconnect: Maintenance Software Overview PEP to Go NOTE: The option to manually delete old QC data is available in the QC > QC Statistics > Tools screen. dou System Samples nventory Calibration ac Patient Orders Worklist Maintenance Setup Schedule Report Log Diagnostics Data Restore Software Updates Copy Configuration Filter Y Module: All Frequency: All Time: Next 24 hours Performed By: All Module All Module Activity Scheduled Fri-14 Sat-15 Sun-16 Mon-17 Tue-18 Wed-19 Thu-20 Perform .. Frequency Al A-01 PP-IA-01 IM Autocheck :::: 4/17/2017 3:30 Mark as Completed Time Next 24 hours A-01 PP-IA-01 Cleaning the Exterior of Reagent Probes :4/13/2017 1:00 4 A A Not Perform Performed By All 14-01 PP.IA-01 Cleaning the Water Container :4/13/2017 1:00 A A A A Search Text Enter the activity name. 1A-01 Procedure Details PP-IA-01 Inspecting and Emptying the IM Water Trap : 4/13/2017 1:00 A A A A IA-01 Edit/View .. Scheduled by Operator ... PP-IA-01 Inspecting and Emptying the IM Dryer 4/17/2017 7:00 A A Scheduled Automatically Scheduled by Service V Database Backup :!: 4/18/2017 0:30 Delete DL-P1-07 L-P1-07 Autocheck for DL ::: 4/18/2017 1:00 V Failed Overdue Database: Optimizing .:::: 4/18/2017 3:00 V V V V Inprocess Database: Archiving and Deleting .:: 4/18/2017 7:00 V V 8 Effective Date: 5-JUL-2020 | HOOD05162003102168 Unrestricted © Siemens Healthcare GmbH, 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 9 Effective Date: 5-JUL-2020 | HOOD05162003102168 Unrestricted © Siemens Healthcare GmbH, 2020