Atellica® Solution CH Test Definition Mitigations Job Aid

CH Test Definition Mitigations Job Aid Atellica® Solution Test Definition Mitigation settings are used to apply contamination avoidance routines for the Atellica CH reagent probes and cuvettes. Please note: • If carryover contamination is suspected to be impacting patient results, immediately report the is- sue to Siemens Healthineers. • Unsupported modifications may affect system performance and test results. • Adding mitigations will impact system throughput. o Mitigations that use the cuvette as the target have a higher negative impact to throughput than mitigations that use reagent as the target, and are recommended only if customer testing demonstrates the need. • The laboratory is responsible for validating mitigations not supported by Siemens Healthineers. Mitigations specify the following: • Conditions for avoiding CH reagent probe contamination • Conditions for avoiding CH reaction cuvette contamination • Type of rinse or wash to avoid reagent contamination Components of Mitigations: • Recipient Assay: The assay that needs to be protected from contamination with the interfering substance in the donor assay. o This is the selected assay from the Test Definition list • Donor Assay: The assay that is the source of an interfering substance which requires mitigation, such as an extra rinse or clean, before performing the recipient assay. • Target: The component the analyzer rinses or cleans. o Reagent (includes reagent probes and reaction mixers) o Cuvette • Mitigation Reagent: The type of rinse or wash used to avoid reagent contamination. o Rinse: With special reagent water o Clean 1: Cleans with the basic CH Reagent Probe Cleaner 1 (RPC1) o Clean 2: Cleans with the acidic CH Reagent Probe Cleaner 2 (RPC2) Unrestricted | Published by Siemens Healthineers AG | © Siemens Healthineers AG, 2025 SIEMENS Master Template Effective Date: 2 Jan 2025 | HILS 2224 Job Aid Effective Date: 17-JAN-2025 | QR700017656 Healthineers Job Aid | CH Test Definition Mitigations Effective Date: 17-JAN-2025 | QR700017656 Access: • Lab Manager level log in is required to make edits. Mitigations can be viewed by all operators. Additional Considerations: • System Defined mitigations will override Operator Defined Mitigations if the same Donor/Target mit- igation is released by Siemens as part of a software update. • Mitigation Donor Assay and Target pairs must be unique. o There can only be a single mitigation per target. The Mitigation screen in the software is divided into 2 sections: A. System Defined Mitigations are the existing mitigations that cannot be modified or deleted B. Operator Defined Mitigations are mitigations that can be added/edited according to lab needs (not supported by Siemens) • When an Operator Defined mitigation is added, modified, or deleted, an event will post to the Operator Event Log • Refer to Online Help for rules on when operator-defined mitigations can be added and modified System Defined Mitigations A Operator Defined Mitigations B Donor Assay Target Mitigation Reagent Unsupported modifications may affect performance of the system and test results. The lab takes responsibility for mitigations not supported by Siemens Healthineers. Fruc Reagent Clean 2 Add Mitigation Remove All Aldo Reagent Clean 2 Aldo Cuvette Clean 2 Donor Assay Target Mitigation Reagent Action APO A1 Reagent Rinse Alb Reagent Clean 2 Remove APO A Cuvette Rinse Alb Cuvette Clean 2 Remove Mtx Reagent Clean 2 AAG Rinse Reagent Rinse Reagent Remove sBnz SIEMENS Unrestricted | Published by Siemens Healthineers AG | © Siemens Healthineers AG, 2025 Master Template Effective Date 2 Jan 2025 | HILS 2224 Healthineers Page 2 of 6 Job Aid | CH Test Definition Mitigations Effective Date: 17-JAN-2025 | QR700017656 To configure an Operator Defined mitigation: 1. Prepare the system to save changes to the assay Test Definition parameters by making sure that no orders exist for the test A. Navigate to Worklist B. Set the filters for Order Time, Sample Type and Analyzer to All C. Sort the worklist by Test D. If orders that include the test exist, perform one of the following: • Wait for any inprocess samples that include the test to complete • Delete any appropriate orders • Move any appropriate orders to the historical database 2. Navigate to CH Test Definition 3. Select the recipient assay from the Test Definition list • This is the assay that needs to be protected from the donor assay 4. Select Mitigation 5. Select Add Mitigation Setup > Test Definition > CH Test Definition 2 3 Select Tests Bnz200 (mg/dL) System Defined Mitigations Operator Defined Mitigations O Definition Donor Assay Target Mitigation Reagent Jnsupported modifications may affect performance The lab takes responsibility for mitigations not suppo Fruc Reagent Clean 2 O Calculation 5 Add Mitigation Remove All Aldo Reagent Clean 2 O Calibration Aldo Cuvette Clean 2 Donor Assay Target 4 Mitigation* APO A1 Reagent Rinse Alb Reagent O Ranges APO A1 Cuvette Rinse Alb Cuvette Mtx Reagent Clean 2 O Repeat Reagent Rinse AAG Reagent sBnz SIEMENS Unrestricted | Published by Siemens Healthineers AG | © Siemens Healthineers AG, 2025 Master Template Effective Date 2 Jan 2025 | HILS 2224 Healthineers Page 3 of 6 Job Aid | CH Test Definition Mitigations Effective Date: 17-JAN-2025 | QR700017656 6. In the Donor Assay field, select the assay that contains the substance that interferes with the assay selected in Step 3 • The button All Assays can be selected to perform this mitigation for all assays NOTE: When All Assays is selected, individual donor assays cannot be defined with the same target. And vice versea – when an individual donor assay is defined, All Assays cannot be defined with the same target. 7. In the Target field, select either Reagent or Cuvette 8. In the Mitigation Reagent field, select 1 of the following: • Rinse: With special reagent water • Clean 1: Uses the basic CH Reagent Probe Cleaner 1 (RPC1) • Clean 2: Uses the acidic CH Reagent Probe Cleaner 2 (RPC2) 9. Select Save Operator Defined Mitigations Unsupported modifications may affect performance of the system and test results. The lab takes responsibility for mitigations not supported by Siemens Healthineers. Add Mitigation Remove All Donor Assay Target Mitigation Reagent Action Alb Reagent Clean 2 Remove Alb Cuvette Clean 2 Remove AAG Reagent Rinse Remove 6 ho Remove All Assays 7 8 AAG B Alb Ca Test 1 Test 2 9 Save Cancel SIEMENS Unrestricted | Published by Siemens Healthineers AG | © Siemens Healthineers AG, 2025 Master Template Effective Date 2 Jan 2025 | HILS 2224 Healthineers Page 4 of 6 Job Aid | CH Test Definition Mitigations Effective Date: 17-JAN-2025 | QR700017656 10. Read the warning statement and then select Yes NOTE: The warning includes the laboratory responsibility to validate any modifications: Unsupported modifications will affect system performance and test results. The laboratory is responsible for validating mitigations not supported by Siemens Healthineers. 11. To continue, select Yes. To cancel, select No. NOTE: To remove all operator-defined mitigations from the assay, select Remove All. To remove one existing mitigation, select Remove at the end of the appropriate row. Operator Defined Mitigations Unsupported modifications may affect performance of the system and test results. The lab takes responsibility for mitigations not supported by Siemens Healthineers. Add Mitigation Remove All Donor Assay Target Mitigation Reagent Action Alb Cuvette Clean 2 Remove AAG Reagent Rinse Remov Ca Reagent Rinse Remove Save Cancel SIEMENS Unrestricted | Published by Siemens Healthineers AG | © Siemens Healthineers AG, 2025 Master Template Effective Date 2 Jan 2025 | HILS 2224 Healthineers Page 5 of 6 Job Aid | CH Test Definition Mitigations Effective Date: 17-JAN-2025 | QR700017656 Please note this 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 ver- sion of the software and hardware available at the time of the training. The Operator Manual shall be used as your main reference, in particular for relevant safety information like warnings and cautions. Please 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 availabil- ity 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. Siemens Healthineers HQ I Siemens Healthineers AG Siemensstr. 3 91301 Forchheim Germany Phone: +49 9191 18-0 siemens-healthineers.com SIEMENS Unrestricted | Published by Siemens Healthineers AG | © Siemens Healthineers AG, 2025 Master Template Effective Date 2 Jan 2025 | HILS 2224 Healthineers Page 6 of 6