VERSANT® kPCR Molecular System Competency Checklist

Competency Checklist VERSANT® kPCR Molecular System 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 initials 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 “Criteria” section below. Use the area on the last page to record comments or areas of improvement. If necessary, the observer 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.): Observer’s Initials Topic/Tasks and Completion Date System Overview- Amplification and Detection (AD) System Identify and explain hardware components of the AD system Navigate and explain software screens of the AD system Sign on and off of the AD system System Overview- Sample Processing (SP) System Identify major components of the SP system Distinguish between the different carriers and their use Describe the kPCR extraction process List the different maintenance procedures System Overview- Tissue Preparation System (TPS) Identify the major system components and describe their function Describe the function of key technology features Identify the system consumables/reagents and locate position on carriers Distinguish between icons in the MICROLAB® STARlet software List the steps of the daily/weekly and after run maintenance Pre-Analytical Create and edit methods on the AD module Assign samples, targets and tasks to wells on the Ad System Sample Processing Describe and perform the nucleic acid extraction process State the purpose of key reagents of the tissue preparation kit List the three protocols of the TPS Run a protocol on the TPS Describe the features that support dynamic assay protocols Navigate the software screens used to run a dynamic protocol Identify common operator errors that can occur when running dynamic protocols Unrestricted | Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2022 SIEMENS Master Template Effective Date: 11-Aug-2021 | HILS2225 Job Aid Effective Date: 13-OCT-2022 | HILS2298 Healthineers Job Aid | VERSANT® kPCR Molecular System Competency Checklist Effective Date: 13-OCT-2022 | HILS2298 Maintenance Perform AD system maintenance after a run Clean the AD system exterior Decontaminate the AD system sample block Rinse the AD system sample block with deionized water Clean the AD system sample block using a 70% ethanol solution Troubleshooting Troubleshoot AD system run errors Troubleshoot AD system plate map errors Troubleshoot AD system report errors Baseline and Threshold Explain baseline and threshold in real-time PCR results Identify the risks of incorrect settings on baseline and threshold Perform manual setup with MiPLX software SIEMENS Unrestricted | Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2022 Master Template Effective Date 11-Aug-2021 | HILS2225 Healthineers Page 2 of 3 Job Aid | VERSANT® kPCR Molecular System Competency Checklist Effective Date: 13-OCT-2022 | HILS2298 Comments Areas of Improvement Next Steps  Primary Operator  Secondary Operator has been trained on the above documented tasks Supervisor: Employee: Date: SIEMENS Unrestricted | Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2022 Master Template Effective Date 11-Aug-2021 | HILS2225 Healthineers Page 3 of 3