Atellica® Solution Final Performance Exercise Evaluation Rubric

Final Performance Exercise Evaluation Rubric Atellica® Solution Configuration:  Sample Handler  Direct Load  Chemistry Analyzer  Immunoassay Analyzer  Sample Handler Connect  Decapper Unrestricted Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2019 SIEMENS Master Template Effective Date: 3/11/2019 | HOOD05162002998095 Healthineers Job Aid Effective Date: 3/31/2019 | HOOD05162003000216 Final Performance Exercise Effective Date: 3/31/2019 | HOOD05162003000216 Task #1: Daily Setup You are to perform the following, using any available reference and education tools as needed: 1. Utilize either Online Help or PEPconnect to find a list of the daily maintenance activities for each module on the system 2. Verify the automated daily maintenance activities have been completed 3. Perform the remaining tasks for daily maintenance 4. Check the status of the analyzer supplies 5. Load supplies and empty waste, as needed 6. Check the status of the reagents 7. Load a new reagent pack on each analyzer 8. Load a new IM primary reagent pack with a new lot, if applicable Tasks 1 2 3 Access either Online Help or PEPconnect and locate a list of the daily maintenance tasks for each module. In PEPconnect, this information can be found in the Maintenance PEP to Go and Practical Exercise documents Access the Maintenance > Log screen and verify the automated Daily Maintenance ac- tivities have completed for the current date CH only: Perform the CH daily maintenance task: Inspect wash probes. Access the Maintenance > Schedule screen to mark the activity as completed Access the Supplies Overview screen and check the status of supplies. Replace supplies and empty waste as needed Access the Reagent Overview screen and check the status of the reagents IM only: Access the IM Test Definition screen and scan the MC TDEF 2D barcodes for the new lot of IM reagent IM only: Prepare an IM primary reagent to be loaded by mixing. Load the IM primary rea- gent pack CH only: Load a CH reagent pack on the system 1: Required step by step directions from the instructor to complete the task. Student unable to answer questions pre- sented by the instructor. 2: Performed the majority of the task with minimal direction from the instructor. Answered questions presented by the instructor after some additional prompts by the instructor. 3: Completed the entire task without assistance from the instructor. Answered questions presented by the instructor cor- rectly. Unrestricted Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2019 Page 2 of 9 Final Performance Exercise Effective Date: 3/31/2019 | HOOD05162003000216 Task #2: Calibration You are to perform the following, using any available reference and education tools as needed: 1. Define a new calibrator for each analyzer 2. Manually create orders for the new calibrator(s) 3. Process a calibration for each analyzer 4. Determine if the calibration results are valid 5. Utilize either Online Help or PEPconnect to determine how to review calibrator result details that would be useful if a calibration result is not valid 6. Review the status of IMT calibration on the CH system (if applicable) Tasks 1 2 3 Access the Calibrator Definitions screen and scan calibrator definitions Access the Create Calibration Orders screen and create orders for calibrators for each an- alyzer If applicable, access the Cal-QC Storage Inventory screen to verify the necessary calibrator material is onboard the Cal-QC storage area If applicable, access the Calibrator Definitions screen to print calibrator barcodes. Use bar- codes to prepare calibrator tubes. Load tubes on the system Access either the Calibration Overview screen or the Calibration Results screen to verify the results are valid Access either Online Help or PEPconnect and locate information on the Calibrator Result Details screen. In PEPconnect, this information can be found in the Calibration PEP to Go and Practical Exercise documents, or in the Reviewing Calibration Results video CH only: Access the IMT Calibration screen to review the IMT calibration results 1: Required step by step directions from the instructor to complete the task. Student unable to answer questions pre- sented by the instructor. 2: Performed the majority of the task with minimal direction from the instructor. Answered questions presented by the instructor after some additional prompts by the instructor. 3: Completed the entire task without assistance from the instructor. Answered questions presented by the instructor cor- rectly. Unrestricted Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2019 Page 3 of 9 Final Performance Exercise Effective Date: 3/31/2019 | HOOD05162003000216 Task #3: Quality Control You are to perform the following, using any available reference and education tools as needed: 1. Create a QC definition for a new lot of QC 2. Manually create orders for the QC to be run that day 3. Process the QC orders on the system 4. Determine if the QC results have passed 5. Review the QC statistics for the QC results 6. Generate a report of the QC data for the past month 7. Utilize either Online Help or PEPconnect to review the procedure for managing QC lot crossovers Tasks 1 2 3 Access the QC Definitions screen. As applicable, either manually create the QC definition or import the QC definition Access the Create QC Orders screen and create QC orders If applicable, access the Cal-QC Storage Inventory screen to verify the necessary QC ma- terial is onboard the Cal-QC storage area If applicable, access the QC Definitions screen to print QC barcodes. Use barcodes to pre- pare QC tubes. Load tubes on the system Access the Results Overview screen to verify the QC results have passed Access the QC Statistics screen to review the statistics for the QC results Access the QC Statistics screen to create a monthly QC report Access either Online Help or PEPconnect and locate information on the QC Lot Crossovers. In PEPconnect, this information can be found in the Quality Control PEP to Go and Practical Exercise documents, or in the Managing QC Lot Crossovers job aid 1: Required step by step directions from the instructor to complete the task. Student unable to answer questions pre- sented by the instructor. 2: Performed the majority of the task with minimal direction from the instructor. Answered questions presented by the instructor after some additional prompts by the instructor. 3: Completed the entire task without assistance from the instructor. Answered questions presented by the instructor cor- rectly. Unrestricted Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2019 Page 4 of 9 Final Performance Exercise Effective Date: 3/31/2019 | HOOD05162003000216 Task #4: Patient Sample Processing You are to perform the following, using any available reference and education tools as needed: 1. Create manual patient sample orders 2. Utilize either Online Help or PEPconnect to review the procedure for creating batch orders 3. Process patient samples on the system 4. Monitor sample tube status 5. Review patient sample results Tasks 1 2 3 Access the Create Patient Orders screen and create patient orders Access either Online Help or PEPconnect and locate information on Creating Batch Orders. In PEPconnect, this information can be found in the Sample Processing PEP to Go and Practical Exercise documents Load sample tubes into the Sample Handler Access either the Sample Handler screen or the Sample List screen to monitor sample tube status Access the Worklist Overview screen to review the patient results 1: Required step by step directions from the instructor to complete the task. Student unable to answer questions pre- sented by the instructor. 2: Performed the majority of the task with minimal direction from the instructor. Answered questions presented by the instructor after some additional prompts by the instructor. 3: Completed the entire task without assistance from the instructor. Answered questions presented by the instructor cor- rectly. Unrestricted Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2019 Page 5 of 9 Final Performance Exercise Effective Date: 3/31/2019 | HOOD05162003000216 Task #5: Maintenance You are to perform the following, using any available reference and education tools as needed: 1. Utilize either Online Help or PEPconnect to find a list of the weekly and monthly maintenance activities for each module on the system 2. Utilize either Online Help or PEPconnect to review the procedure for performing one of the weekly or monthly maintenance activities Tasks 1 2 3 Access either Online Help or PEPconnect and locate a list of the weekly and monthly maintenance tasks for each module. In PEPconnect, this information can be found in the Maintenance PEP to Go and Practical Exercise documents Access either Online Help or PEPconnect and locate the procedure for one of the maintenance tasks. In PEPconnect, this information can be found in the Maintenance PEP to Go or in the Maintenance videos and job aids 1: Required step by step directions from the instructor to complete the task. Student unable to answer questions pre- sented by the instructor. 2: Performed the majority of the task with minimal direction from the instructor. Answered questions presented by the instructor after some additional prompts by the instructor. 3: Completed the entire task without assistance from the instructor. Answered questions presented by the instructor cor- rectly. Unrestricted Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2019 Page 6 of 9 Final Performance Exercise Effective Date: 3/31/2019 | HOOD05162003000216 Task #6: Troubleshooting You are to perform the following, using any available reference and education tools as needed: 1. Locate the Operator Event Log on the system 2. Utilize Online Help to locate the corrective action for one of the errors in the Operator Event Log 3. Utilize either Online Help or PEPconnect to locate the procedures for shutting down the system and for starting the system Tasks 1 2 3 Access the Operator Event Log screen Locate the corrective action for an error by using ‘Event Help’ on the Operator Event Log screen Access either Online Help or PEPconnect and locate the procedures for “Shutting Down and Powering Off the System” and “Starting the System”. In PEPconnect, this information can be found in the Troubleshooting PEP to Go document 1: Required step by step directions from the instructor to complete the task. Student unable to answer questions pre- sented by the instructor. 2: Performed the majority of the task with minimal direction from the instructor. Answered questions presented by the instructor after some additional prompts by the instructor. 3: Completed the entire task without assistance from the instructor. Answered questions presented by the instructor cor- rectly. Unrestricted Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2019 Page 7 of 9 Final Performance Exercise Effective Date: 3/31/2019 | HOOD05162003000216 Comments Areas of Improvement has completed this exercise Observer: Trainee: Date: Unrestricted Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2019 Page 8 of 9 Final Performance Exercise Effective Date: 3/31/2019 | HOOD05162003000216 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 2019 ………………………………………………………… Siemens Healthineers Headquarters Siemens Healthcare GmbH Henkestr. 127 91052 Erlangen, Germany Telephone: +49 9131 84-0 siemens.com/healthineers Unrestricted Published by Siemens Healthcare GmbH © Siemens Healthcare GmbH, 2019 Page 9 of 9