Atellica® Solution Competency Checklist Version 1.25 and Below

Competency Checklist Atellica® Solution Once an employee has acquired the necessary knowledge and skills to perform basic operation tasks this checklist can be used to observe the employee perform the required tasks for their core job responsibilities and to document demonstrated competency. The observer places their ini- tials and date beside the task when it is performed successfully. Successful completion for each task is determined by the facility. The standards used to evaluate can be documented in the “Cri- teria” section below. Use the area on the last page to record comments or areas of improvement. If necessary, the ob- server can record recommended next steps of action for areas of improvement or development opportunities. When all required tasks are completed, the supervisor and employee sign and date this document as a record of completion. Criteria - Standards for successful completion of each task (e.g. Accuracy, Time, Quality, etc.): Configuration:  Sample Handler  Direct Load  Chemistry Analyzer  Immunoassay Analyzer  Sample Handler Connect  Decapper Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 SIEMENS Master Template Effective Date: 3/11/2019 | HOOD05162002998095 Healthineers Job Aid Effective Date: 21-FEB-2020| HILS1800 Competency Checklist Effective Date: 21-FEB-2020| HILS1800 Observers Initials and Completion Topic/Tasks Date System Overview Identify and explain hardware components Identify the types of sample containers that can be processed on the sys- tem Describe the sample and test processing sequences Navigate and explain the Asa software on the tablet Describe how to use the operator tablet Describe how to use the module display Navigate and explain software screens Recognize and access system alerts Search for sample results View sample and test status Access PEPconnect Access and search the online help Use the onscreen keyboard Sign on and off of the system Supply and Reagent Management Monitor the status of the supply and reagent inventories Load and unload IM primary and ancillary reagent packs Load and unload CH reagent packs Load IM humidity packs Replace / empty supplies and waste Cal-QC Storage Area (Sample Handler configurations only) Monitor onboard storage of calibrator and quality control materials Load materials in the Cal-QC storage area Sample Processing Load samples on the system Monitor sample tube status Process STAT samples Order patient tests manually, individually and by batch Edit multiple orders View order status and manage results Print results Utilize the Dashboard Utilize Monitoring to quickly identify and address samples Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 Page 2 of 6 Competency Checklist Effective Date: 21-FEB-2020| HILS1800 Quality Control Define QC Determine the QC materials that need to be loaded on the system Process QC samples Monitor QC results Generate QC reports Manage QC lot crossovers Calibration Describe how the system utilizes reagent lot and pack calibration intervals to determine calibration frequency Determine the calibrator QC materials that need to be loaded on the system Review calibration status Install CH calibrator definitions Order CH calibrations manually Manually create IMT calibrations Print calibrator barcodes Review calibration results Describe CH assay reagent calibrations Describe C0 adjust pack calibrations Describe IMT calibrations View IMT calibrations Scan IM Master Curve and Assay Test Definition 2D barcodes Install IM calibrator definitions Order IM calibrations manually Configure the system for automatic calibration ordering Describe IM assay reagent calibrations Maintenance Perform daily maintenance Perform weekly maintenance Perform monthly maintenance Perform as needed maintenance Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 Page 3 of 6 Competency Checklist Effective Date: 21-FEB-2020| HILS1800 Troubleshooting Identify the logs available in the software Utilize the Operator Event Log Identify and resolve common system errors Locate the System Name, Serial Number, and Version Information Perform shutdown and startup Review steps to contact the Siemens Customer Care Center Utilize the Remote Assistance tool Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 Page 4 of 6 Competency Checklist Effective Date: 21-FEB-2020| HILS1800 Comments Areas of Improvement Next Steps ◼ Primary Operator ◼ Secondary Operator has been trained on the above documented tasks Supervisor: Employee: Date: Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 Page 5 of 6 Competency Checklist Effective Date: 21-FEB-2020| HILS1800 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 (herein- after 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 varies by country and is subject to varying regulatory requirements . Please contact your local rep- resentative 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 Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2020 Page 6 of 6