Creating QC Definitions on the Atellica® Solution Job Aid Version 1.26 and Above

Creating QC Definitions on the Atellica® Solution Job Aid SIEMENS Healthineers QC Definitions QC levels can be combined into a single definition, which allows QC to be treated as a group instead of individual levels A. Parent Lot – Overall lot for the control material, including all levels B. Each level is assigned an individual Control Lot This allows for: • A QC definition for a new lot of QC can use the same material name as was used for the old lot, with a new Parent Lot QC > QC Definitions 8 H1-SCI1 LabManager NOTE: Kitted controls that require the checksum value, such as for EHIV, must be Edit QC Definition ? × defined one control per definition to accommodate for the checksum. Control Details Control Name Specimen * AFP_Control Serum/Plasma Primary Store Onboard A Parent Lot * Control Type * 311 Level 1 Level 2 Level 3 Level 4 Level 5 Level 6 Level 7 Level 8 Level 9 Routine Select Tests Level Details Assay Type All Level 1 Level 2 Level 3 Q Search Control ID + Control Lot . B Control Lot Expiration * 301 333311 12/14/2021 AAG AAT Test Name Units SD Low High Mean +/- Range Result OBS Days OBS Hours Amp300 Amp1000 AST ALT Template Effective Date: 10 Aug 2021 | HILS 2223 1 AFP mmol/L 1 1 2 1.5 0.5 ALTPLC AFP Effective Date:18-MAY-2023| HOOD05162003352821 Unrestricted © Siemens Healthineers, 2023 Creating QC Definitions on the Atellica® Solution Job Aid SIEMENS Healthineers Options for Creating QC Definitions • Create QC definitions manually – for any QC materials • Import QC definitions* – from the supplier, from Document Library for Siemens QC, or from another analyzer • Scan QC definition barcodes – only for Siemens QC NOTE: Keep in mind that there are features in the software that are useful when adding a new lot of QC: • Lab Evaluations > QC Parallel • Guided Workflows > QC Setup Refer to Online Help for more information on these features. *NOTE: The procedure for importing QC definitions can be found in the “Exporting and Importing QC Definitions on the Atellica Solution Job Aid” on PEPconnect. 2 Effective Date:18-MAY-2023| HOOD05162003352821 Unrestricted © Siemens Healthineers, 2023 Creating QC Definitions on the Atellica® Solution Job Aid SIEMENS Healthineers Creating New QC Definitions Manually QC > QC Definitions SH1-SCI abManager 1. Navigate to QC Definitions Filters Tx Clear Filters: Material Name: All X Status: Active X Import Scan Barcodes Add Manually 2. Select the Add Manually button 2 Material Name All Material Name Levels Lot Lot Explration Usage Specimen Type Store 3. Enter the following information: Control Name, Parent Lot, Status Active O QC_K_NA 1, 2, 3, 4, 5, 6 122 2/12/2021 Primary Serum/Plasma V Edit/View Specimen, Control Type, Usage, Level(s) Add QC Definition ? X Parent Lot - Lot for the control material, including all Control Details levels. Additional, individual control lot numbers are 3 Control Name * Specimen . Serum/Plasma Usage* Parallel Store Onboard assigned for each level Parent Lot * Control Type * Routine Level 1 Level 2 Level 3 Level 4 Level 5 Level 6 Level 7 Level 8 Level Specimen - Select the Specimen type associated with the Select Tests Level Details Assay Type tests that the control supports Control ID * Control Lot * Control Lot Expiration * Q Search Test Name Units SD Low High Mean +/- Range Result OBS Days OBS Hours ➢ The operator must select Serum/Plasma specimen type AAG AAT Amp300 Amp100 for controls associated with tests for Serum, Plasma, or AST ALT both. This specimen type applies to QC samples only ALTPLC AFP Amylas Acet QC Type - The following options are available: Brb200 Brb300 Bnz200 Bnz300 ➢ Routine – independent from the reagent kits and do Ca -2 Chol_2 Crea_2 Clear All Ranges Observed Ranges not require a checksum Save Cancel ➢ Kit – require a checksum and may be lot-locked or control bracketed *This procedure is continued on the next slide 3 Effective Date:18-MAY-2023| HOOD05162003352821 Unrestricted © Siemens Healthineers, 2023 Creating QC Definitions on the Atellica® Solution Job Aid SIEMENS Healthineers Creating New QC Definitions Manually (continued) Add QC Definition ? X 3. continued: Control Details 4 Usage - The following options are available: Control Name * Specimen . Usage * ChemistryQC Serum/Plasma Primary Store Onboard Parent Lot . 122 Control Type * Routine Level 1 Level 2 Level 3 Level 4 Level 5 Level 6 Level 7 Level 8 Level 9 ➢ Primary – Selected by the system when a lot is not specified. Primary controls that produce QC results Select Tests Level Details that determine patient QC flagging in QC statistics Assay Type All Level 1 Q Search ➢ Parallel* – Parallel control results generate Control ID Control Lot * Control Lot Expiration * AAG AAT Test Name Units SD Low High Mean +/- Range Result OBS Days OBS Hours observed ranges, but do not generate violations or Amp300 Amp1000 flags for test evaluations AST ALT ALTPLC AFP ➢ Alternate – The operator performs alternate Amylas Acet control lots for additional QC flagging and Brb 200 Brb300 Bnz200 Bnz300 statistical data C3 Ca-2 ➢ Not in Use – The control lot is no longer active, Chol_2 Crea_2 Clear All Ranges Observed Ranges Save Cancel such as when it is expired 4. If the QC material will be stored onboard, select the Store Onboard checkbox. (Only available in Sample *NOTE: The Parallel usage type works together with the Lab Evaluation > QC Parallel study. Handler configurations) ➢ When running QC with onboard controls, the system deploys the QC material once the order is generated *This procedure is continued on the next slide 4 Effective Date:18-MAY-2023| HOOD05162003352821 Unrestricted © Siemens Healthineers, 2023 Creating QC Definitions on the Atellica® Solution Job Aid SIEMENS Healthineers Creating New QC Definitions Manually (continued) Add QC Definition ? X 5. Select the appropriate test(s). The Assay Type drop down can be used to filter the list Control Details Control Name * Specimen . ChemistryQC Serum/Plasma Primary Store Onboard 6. For each level: Parent Lot * Control Type * 122 Level 4 Routine Level 1 Level 2 Level 3 Level 5 Level 6 Level 7 Level 8 Level 9 6 A. Enter the Control ID, Control Lot, Control Lot Select Tests Level Details Expiration 5 Assay Type All Level 1 Level 3 A B. Enter the SD (Standard Deviation) for each assay* Q Search Contro Control Lot . Control Lot Expiration * 1221 01/31/2022 D AAG AAT Test Name Units Low High +/- Range Result OBS Days OBS Hours C. Enter the target values for each assay by entering Amp300 Amp1000 either the Low and High limits OR the mean and AST ALT AST mmol/L +/- Range * ALTPLC AFP ALT mmol/L Amylas Acet AFP mmol/L D. Enter the Onboard Stability Days or the Onboard Brb 200 Brb300 Stability Hours Bnz200 C Bnz300 B C3 Ca-2 E. Select the Save button Chol_2 Crea_2 Clear All Ranges Observed Ranges E Save Cancel *NOTE: There is an option to enter “N/A” for SD and to not enter target values, which would allow the controls to run without entering ranges. There is also an option to enter “QUAL” for SD. 5 Effective Date:18-MAY-2023| HOOD05162003352821 Unrestricted © Siemens Healthineers, 2023 Creating QC Definitions on the Atellica® Solution Job Aid SIEMENS Healthineers Scanning QC 2D Barcodes ‹ A QC > QC Definitions 8 H1-SCI1 abManager Navigate to QC Definitions Filters Tx Clear Filters: Material Name: All X Status: Active X 1. Import Scan Barcodes Add Manually 2. Select the Scan Barcodes button Material Name All Material 2 Levels Lot Lot Expiration Usage Specimen Type Store Status Active Active O QC_K_NA 1, 2, 3, 4, 5, 6 122 12/12/2021 Primary Serum/Plasma V Edit/View 3. Scan the QC 2D barcode ? HX Scan QC Definition 4. Select the appropriate check box for Test Name Scan the 2D barcode from QC sheet using the Barcode Scanner 7 QC Material* for the definitions to save 6 Usage Control Se 40960T Store Onboard MULTI_QC Primary QC Lot QC Material ID Lot Expiration QC Typ Checksum Specimen 5. Confirm the scanned information Serum 40961T 03/29/2024 Primary 03/29/2024 Primary Serum 40962T 6. Select the Usage (Primary, Parallel, Alternate, or 40963T 03/29/2024 Primary Serum Not in Use) Test Name Reagent 4 Details Usage QC Lot QC Level Units SD Typ Low High Mean Result Open Stability Days Open Stability Hours Acet 3 Levels 7. If the QC material will be stored onboard, select Primary 40961T 1 mg/dl 0.647 1.19 0.916 14 O Primary 40962T mg/dl 2 2.85 3.90 3.38 14 0 the Store Onboard checkbox. (Only available in O N Primary 40963T mg/dl 9.13 11.9 10.5 14 Sample Handler configurations) O Carb 3 Levels Primary 40961T ug/ml 2.29 3.34 2.82 14 0 N . Primary 40962T ug/mL 7.31 9.73 8.52 14 0 ➢ When running QC with onboard controls, the N Primary 40963T 3 ug/ml 11.8 15.5 13.6 14 0 system deploys the QC material once the order O CEA 3 Levels Primary 40961T 1 ng/ml 2 1.73 2.81 2.27 14 o 0 is generated Primary 40962T ng/ml 2 12.5 18.0 15.2 14 N 14 Primary 40963T ng/ml 30.3 43.4 36.9 o N 3 Levels 8. Select Save O CKMB Primary 40961T 1 ng/ml 2 2.40 3.68 3.04 14 0 8 Save Cancel 6 Effective Date:18-MAY-2023| HOOD05162003352821 Unrestricted © Siemens Healthineers, 2023 Creating QC Definitions on the Atellica® Solution Job Aid SIEMENS Healthineers Editing Existing QC Definitions QC > QC Definitions 6 LabManager To edit a QC definition: Filters Tx Clear Filters: Material Name: All 1. Navigate to QC Definitions Add New Import Material Name All Material Name Levels Lot Lot Expiration Usage Specimen Type Store 2. Select the QC definition to edit Usage 2 Parallel QC_K_NA 1,2,3,4,5,6 122 05/09/2020 Primary Serum/Plasma 3 Edit/View 3. Select the Edit/View button AFP Control 1,2,3 AF1 11/30/2020 Serum/Plasma Copy 0 Expiration Status Primary ➢ The Edit QC Definition screen will display Delete Assay Type Export Q Search Assay Print Barcode *This procedure is continued on the next slide NOTE: If an open QC order exists for the control material, the operator cannot edit the QC definition. NOTE: In a Sample Handler configuration, before editing an existing QC definition, remove the control samples associated with the QC definition from the Cal-QC Storage Area. After saving the edits, restore the control samples to the Cal-QC Storage Area. 7 Effective Date:18-MAY-2023| HOOD05162003352821 Unrestricted © Siemens Healthineers, 2023 Creating QC Definitions on the Atellica® Solution Job Aid SIEMENS Healthineers Editing Existing QC Definitions (continued) Edit QC Definition ? X QC Details 4. If desired, edit the target ranges by selecting the Low, High, Mean, 6 QC Material . Specimen * Usage* QCPAF Serum/Plasma Primary Store onboard oc with CAL Parent Lot . QC Type or +/- Range field and entering the new value 66689 Routine Level1 Level2 Level3 Level4 Level5 Level6 Level7 Level8 Level9 Select Tests Level Details 5. To set the target ranges to match the current observed ranges: Assay Type Level 1 O QC Material ID . QC Lot . QC Lot Expiration . Select the Observed Ranges button QC011139 66689 A. 9/16/2021 SD Open Stability Days Open Stability CL Test Name Low High Mean +/- Range Result SD K NA ➢ The observed QC ranges for this control, based on QC data APP naimL 113.2 Result O - g AAG AAT generated on this system, will display ACE Acet 4 AFP Alb AlbP Aldo B. Select the checkbox next to the appropriate control range ALP_2C ALT ALTPLC Amik A Amm AMY_2 C. Select the Copy button Amylas APO A1 Clear All Ranges Observed Ranges ➢ The Edit QC Definition screen will display with the new 7 Save Cancel target ranges QC Observed Ranges ? = X 6. If the QC lot has been run as a parallel lot for observation, and will C QC Details Copy QC Material QC Level QC Lot now be the primary lot, change the Usage to Primary OCPAF 66689 Select the Save button Test Name Module Name Observed Results SD Low High Mean (Observed) -/- Range 7. O B O AFP SCI1 289.0 NOTE: If the QC lot had been run as a parallel lot and was changed to primary, the operator should also edit the definition for the old primary lot and change the usage to Not in Use. 8 Effective Date:18-MAY-2023| HOOD05162003352821 Unrestricted © Siemens Healthineers, 2023 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 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 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 representative for availability. © Siemens Healthcare GmbH 2023 Siemens Healthineers Headquarters Siemens Healthcare GmbH Henkestr. 127 9 91052 Erlangen, Germany Telephone: +49 9131 84-0 Effective Date:18-MAY-2023| HOOD05162003352821 siemens-healthineers.com Unrestricted © Siemens Healthineers, 2023