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Atellica® Solution Quality Control PEP to Go Version 1.25 and Below

PEP to Go is an education resource material designed to support competency mastery on-the-job.

SIEMENS Healthineers .- -- E 0 IM Atellica Solution Healthineers Atellica® Solution Quality Control PEP to Go 1 Template Effective Date: 27-MAY-2019 | HOOD05162003010284 Effective Date: 06-APR-2020 | HOOD05162003077519 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® Solution SIEMENS Quality Control Process Healthineers Define QC Process QC Samples Monitor QC Results Generate QC Manage QC Lot Reports Crossovers • Create new QC • Determine QC Print QC reports • Workflow for • definitions manually • View QC data, needs charts, and statistics managing QC • • Import QC definitions • Create QC orders Export QC reports Use Patient Data for lot crossovers • • Edit QC definitions • Print QC barcodes QC Statistics (use observed • • ranges) Monitor in-progress Monitor QC flagging QC test orders and view results 2 Effective Date: 06-APR-2020 | HOOD05162003077519 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® Solution SIEMENS Define QC Healthineers Creating New QC Definitions SIEMENS .. Healthineers Atellica Solution Version 1.17.0.3146003 1 P-P1-03 To manually create a QC definition: System Samples Inventory Calibration Qc * E Patient Orders Worklist Maintenance Setup Create QC Orders Control Bracketing QC Statistics Patient QC Flaggin 2 QC Definitions QC Panels QC Scheduler 1. At the Command Bar, select QC Add New QC Definition X Control Details 2. Select the QC Definitions tab Control Name Control Lot Specimen Serum/Plasma 4 Control ID Control Lot Expiration 10/17/2018 15 Control Type Routine 3. Select the Add QC Definition button Level Usage Primary Store Onboard Perform QC with Calibration Perform QC on Pack Change 4. Enter the following information: Control Name, Control Tests 1 Test Name Units SD LOW High @ Mean ? Range Result Open Stability > Open Stability Clear All Ranges Hours I Lot, Specimen, Control ID, Control Lot Expiration, Control Days L CL Observed Ranges Type, Level, Usage NA AAG AAT Specimen - Select the Specimen type associated with the Acet AFP tests that the control supports aHAVM Alb AlbP ALP_2c ➢ The operator must select Serum/Plasma specimen type ALT ALTPLC Amik AMY 2 for controls associated with tests for Serum, Plasma, or Save Cancel both. This specimen type applies to QC samples only QC Orders. Import 3 Add QC Definition. Control Type - The following options are available: ? PEP LabManager Tuesday, November 27, 2018 10:01 AM ➢ Routine controls – independent from the reagent kits and do not require a checksum ➢ Kit controls – require a checksum and may be lot- locked or control bracketed *This procedure is continued on the next slide 3 Effective Date: 06-APR-2020 | HOOD05162003077519 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® Solution SIEMENS Define QC Healthineers Creating New QC Definitions (continued) Add New QC Definition x Usage - The following options are available: Control Details Control Name YPH CH L1 Control Lot 14491 Specimen Serum/Plasma ➢ Primary – Primary controls that produce QC results Control ID 4491 Control Lot Expiration 12/31/2019 15 Control Type Routine that determine patient QC flagging in QC statistics Level Usage Primary ➢ Parallel – The operator can perform new control 5 Store Onboard Perform QC with Calibration Perform QC on Pack Change Tests lots in parallel with primary control lots for QC SD/ - Low/- High Mean ? +/- Result Open Stability Open Stability Clear All Ranges H Test Name Units - statistics. Parallel control results generate observed Range Days Hours L CL Alb g/dl 3 3.8 4.34 4.07 0.27 Observed Ranges ranges, but do not generate violations or flags for K NA test evaluations AAG AAT ➢ Alternate – The operator performs alternate Acet AFP control lots for additional QC flagging and aHAVM Alb statistical data AlbP ALP 20 ALT ALTPLC ➢ Not in Use – The control lot is expired Amik AMY 2 5. If the QC material will be stored onboard, select the ? Save Cancel Store Onboard checkbox. (Only available in Sample Handler configurations) ➢ When running QC with onboard controls, the system retrieves the control sample automatically as part of the QC order *This procedure is continued on the next slide 4 Effective Date: 06-APR-2020 | HOOD05162003077519 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® Solution SIEMENS Define QC Healthineers Creating New QC Definitions (continued) Add New QC Definition x 6. To enable the QC lot to be configured to run Control Details automatically with calibrations, select the Perform Control Name YPH CH L1 Control Lot 14491 Specimen Serum/Plasma Control ID 4491 with Calibration checkbox Control Lot Expiration 12/31/2019 15 Control Type Routine Level Usage Primary ➢ To complete the setup of performing QC with Store Onboard 6 Perform QC with Calibration 7 Perform QC on Pack Change calibration, navigate to Setup > Test Definition and Tests 8 select the Perform QC with Calibration checkbox H Test Name Units 9 SD Low High Mean ? +/- Result Open Stability Open Stability Clear All Ranges Range Days Hours - for the desired test definition L CL Alb g/dl 3 3.8 4.34 4.07 0.27 Observed Ranges K NA 7. To enable the QC to be run automatically with a 10 AAG AAT reagent pack change, select the Perform QC on Pack Acet AFP Change checkbox aHAVM Alb ➢ To complete the setup of performing QC with pack AlbP ALP 20 change, navigate to Setup > Settings > General ALT ALTPLC Setup and select the appropriate QC on Pack Amik AMY 2 Change setting under QC Mode Settings ? Save Cancel 8. Select a test *NOTE: There is an option to enter “N/A” for SD and to not enter target values, which 9. Enter the SD (Standard Deviation)* would allow the controls to run without entering ranges. There is also an option to enter 10. Enter the target values by entering either the Low and “QUAL” for SD. High limits OR the mean and +/- Range * *This procedure is continued on the next slide 5 Effective Date: 06-APR-2020 | HOOD05162003077519 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® Solution SIEMENS Define QC Healthineers Creating New QC Definitions (continued) Add New QC Definition x 11. Enter the Open Stability Days and the Open Stability Control Details Hours * Control Name YPH CHL1 Control Lot 14491 Specimen Serum/Plasma Control ID 4491 Control Lot Expiration 12/31/2019 15 Control Type Routine 12. Add additional tests as needed Level Usage Primary 13. Select the Save button Store Onboard Perform QC with Calibration Perform QC on Pack Change Tests H Test Name Units SD - Low/- High Mean ? +/- Result Open Stability Open Stability Clear All Ranges Range Days Hours - L CL Alb g/dl 3 3.8 4.34 4.07 0.27 Observed Ranges K NA 11 AAG AAT Acet AFP aHAVM Alb AlbP ALP 20 ALT ALTPLC Amik AMY 2 ? 13 Save Cancel *NOTE: The Open Stability fields are only applicable to Sample Handler configurations. 6 Effective Date: 06-APR-2020 | HOOD05162003077519 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® Solution SIEMENS Define QC Healthineers Exporting and Importing QC Definitions SIEMENS Healthineers Atellica® Solution Version 1.17.0.3146003 P-P1-0 K 1 To import a QC definition, first obtain the QC definition as an xml file: System Samples Inventory Calibration Qc Patient Orders Worklist Maintenance Setup Create QC Orders Control Bracketing QC Statistics Patient QC Flagging QC Definitions QC Panels QC Scheduler 2 • Export the QC definition xml file from an Atellica Solution system to Filter ... Status: All Control Name Control Level Control ID be imported on either the same system or a different system Control Lot Control Lot Expiration Usage Specimen Type Date Last Used Ederview Cardiac MarkersT 430236611 23661T 01/31/2019 Primary Serum,Plasma 04/25/2018 3 Copy- Cardiac MarkersT 5 430236657 23665T 01/31/2019 Primary Serum,Plasma 04/27/2018 OR Cardiac MarkersT 3 43023663T 23663T Browse For Folder Serum,Plasma 04/27/2018 Delete Cardiac MarkersT 2 43023662T 23662T Export QC Definitions Serum,Plasma 04/25/2018 Chem control 26430 5 4 2 ChemCon2 26432 Serum, Plasma 07/31/2018 Export ... • Obtain the QC definition xml file from the supplier D StagingArea Chem control 26430 1 Chemcon1 28431 SystemSpecificConfigs Serum,Plasma 07/31/2018 Print Barcode .. CM PLUS 1 29861 29861 p Temp - USERROOT Serum, Plasma 08/22/2017 The operator can transfer the xml file to the system using local media CM PLUS 2 2 29862 29862 .Database Archives and Database Backups Serum,Plasma 08/22/2017 CM PLUS 3 3 29863 29863 Exports Loggrabber Serum,Plasma 08/22/2017 such as a USB drive. If the system is connected to a local network, the EHIV-NEG031 K7681 307681 ]] Paint Serum, Plasma 02/13/2018 Print To File Reports EHIV-POS032 2 K7682 307682 Results Wklist A Serum, Plasma 02/13/2018 operator can transfer the xml file to the system from the network. EHIV-POS033 3 K7683 307683 SystemUtils Serum, Plasma 02/13/2018 EHIV-POS034 K7684 307684 Make New Folder OK Cancel Serum,Plasma 02/13/2018 HAVM Neg HAVNeg 7010381 07/31/2019 6 Primary Serum, Plasma 10/03/2017 To export the QC definition xml file from an Atellica Solution system: HAVM POS 2 HAVPOS 7010382 07/31/2019 Primary Serum, Plasma 10/03/2017 HBsll Neg NEG631 6315471 07/31/2019 Primary Serum,Plasma 03/29/2018 1. At the Command Bar, select QC HBSIPOS POS632 6315472 07/31/2019 Primary Serum,Plasma 03/29/2018 QC Orders ... Import Add QC Definition .. 2. Select the QC Definitions tab ? PEP LabManager Tuesday, November 27, 2018 10:01 AM 3. Select the definitions to export NOTE: When exporting multiple QC definitions, the system creates one export file for 4. Select Export each control name. If multiple definitions have the same name, one file will be Select the folder location to place the exported QC definition xml created for that name. 5. file NOTE: If using a USB to transfer the xml file, the operator must remove the USB prior 6. Select OK to restarting the system. If the USB is in the system during a restart, the system tries to reboot from the USB drive. ➢ After the export completes, the xml files can be obtained from the folder 7 Effective Date: 06-APR-2020 | HOOD05162003077519 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® Solution SIEMENS Define QC Healthineers Importing QC Definitions SIEMENS. Healthineers Atellica® Solution Version 1.17.0.3146003 K 1 P-P1-0 To import the QC definition xml file into the Atellica Solution System Samples Inventory Calibration Patient Orders Worklist Maintenance Setup Create QC Orders Control Bracketing QC Statistics Patient QC Flagging 2 QC Definitions QC Panels QC Scheduler software: Filter ... Y Status: Al 1. At the Command Bar, select QC Control Name Control Level Control ID Control Lot Control Lot Expiration Usage Specimen Type Date Last Used Edit/View Cardiac MarkersT 1 43023661T 23661T 01/31/2019 Primary Serum, Plasma 04/25/2018 Cardiac MarkersT Import QC Definition Serum,Plasma Copy. 04/27/2018 2. Select the QC Definitions tab Cardiac MarkersT 3 X Serum,Plasma 04/27/2018 Delete Cardiac MarkersT File name G:\Biorad files\ImmunoassayPlus_40930T_11082016 Browse. 04/25/2018 Chem control 26430 2 Import QC Definition X 3. Select Import 07/31/201 Export Chem control 26430 1 File name G:\Biorad files\ImmunoassayPlus_40930T_11082016 Browse. 4 07/31/2018 Print Barcode CM PLUS 1 6 CM PLUS 2 Import enabled tests only 08/22/2017 4. Select Browse and navigate to the QC definition xml file 2 29862 08/22/2017 CM PLUS 3 29863 7 Import Cancel 08/22/2017 EHIV-NEG031 K7681 02/13/2018 5. Select OK EHIV-POSO32 K7682 307682 07/21/2019 Primary Serum,Plasma 02/13/2018 mport QC Definition X Serum, Plasma 02/13/2018 Control Name IA Plus Liq Tube Control Set 40930T 6. To import only the tests enabled on the system, select the Serum,Plasma 02/13/2018 Control Lot Control ID Lot Expiration Usage Control Type Checksum Specime Store Onboard Perform QC with Calibration Serum, Plasma 10/03/2017 40931T 0429409317 10/31/2040 15 Primary Routine Import enabled tests only checkbox 40932T 042940932T 10/31/2040 15 Primary Routine Serum,Plasma 10/03/2017 40933T 0429409331 10/31/2040 15 Primar Routine Serum,Plasma 03/29/2018 Test Name Usage Control Lot Control Level Units D Type Low Hig Mean Result Open Stability Open Stability Serum,Plasma 03/29/2018 7. Select Import Days @ V/AFP Hours 3 Level Primary 40931T 37.5 31.6 Orders .. 3 Import Add QC Definition. Primary 40932T TWYOU 101 124 ➢ The Import QC Definition screen will display, with the Primary 40933T 302 259 0 Tuesday, November 27, 2018 10:01 AM CEA 3 Level definition data filled in Primary 40931T ng /ml 1.8 L73 2.96 Primary 40932T ng/ml 5.8 8.46 Primary 40933T ng/ml 8.8 16 8. Select the appropriate tests to import V FSH Level Primary 40931T miU/ML 6.46 9.28 7.87 0 Primary 40932T miU /mL 17.1 23.8 20.4 14 Primary 40933T 3 miU /ml 43.7 58.9 51.3 9. Select Save @ V ThCG 3 Level Primary 40931T nit /m 2 76 6.3 1 53 14 9 Save Cancel *NOTE: When importing QC Definitions for Serum or Plasma controls, the system defines the Specimen type as Serum/Plasma and imports all tests defined in the Test Definition as Serum or Plasma or both. 8 Effective Date: 06-APR-2020 | HOOD05162003077519 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® Solution SIEMENS Define QC Healthineers Editing Existing QC Definitions SIEMENS P-P1-03 Healthineers Atellica Solution Version 1.17.0.3146003 1 To edit a QC definition: Calibration Patient Orders Worklist Maintenance Setup System Samples Inventory Create QC Orders Control Bracketing QC Statistics Patient QC Flagging QC Definitions QC Panels QC Scheduler 1. At the Command Bar, select QC 2 Filter. Y Status: All 4 Control Name Control Lot Control Lot Expiration Usage Specimen Type Date Last Used Edit View .. Select the QC Definitions tab Control ID 2. Control Level 3 Tumor 3 54633 54633 9/30/2019 Primary Serum, Plasma 2/16/2018 Copy ... Serum, Plasma 2/16/2018 Tumor 2 2 54632 54632 9/30/2019 Primary 3. Select the QC definition to edit Tumor 1 54631 2/16/2018 Delete 1 54631 9/30/2019 Primary Serum,Plasma LYPH CH L1 1 14491 14491 10/31/2018 Primary Serum, Plasma 4/11/2017 Select the Edit/View button 42940943T 40943T 6/30/2019 Primary Serum, Plasma 10/16/2018 Export .. 4. Immunoassay Plus3 3 10/16/2018 Immunoassay Plus2 2 42940942T 40942T 6/30/2019 Primary Serum,Plasma Print Barcode. Immunoassay Plus1 1 42940941T 40941T 6/30/2019 Primary Serum,Plasma 10/16/2018 ➢ The Edit QC Definition screen will display M Plus 3 40353 40353 5/31/2020 Primary Serum,Plasma 9/5/2018 IM Plus 2 40352 40352 5/31/2020 Primary Serum,Plasma 3/5/2018 IM Plus 1 40351 40351 5/31/2020 Primary Serum,Plasma /5/2018 HBsIlPOS632 2 6304492 6304492 2/13/2019 Primary Serum, Plasma 8/9/2018 Serum, Plasma 8/9/2018 HBsIlNEG631 6304491 6304491 2/13/2019 Primary HAVM Pos 2 7030072 7030072 2/28/2019 Primary Serum, Plasma 9/9/2018 *This procedure is continued on the next slide HAVM Neg 703007 7030071 2/28/2019 Primary Serum,Plasma 9/9/2018 EHIV-POS034 K8684 328684 10/13/2018 Primary Serum,Plasma 9/24/2018 EHIV-POS033 3 K8683 328683 10/13/2018 Primary Serum, Plasma 9/24/2018 EHIV-POS032 2 K8682 328682 10/13/2018 Primary Serum, Plasma 9/24/2018 QC Orders .. Import Add QC Definition .. 1000000000000000000 ? PEP LabManager ES Tuesday, November 27, 2018 10:01 AM 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. 9 Effective Date: 06-APR-2020 | HOOD05162003077519 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® Solution SIEMENS Define QC Healthineers Editing Existing QC Definitions (continued) Edit QC Definition X 5. If desired, edit the target ranges by selecting the Low, High, Control Details Control Name Assayed Chem Control Control Lot 14491 Mean, or plus or minus range field and entering the new value Control ID K1449 Control Lot Expiration 11/30/2017 15 Control Type Routine Level 1 Usage Primary 7 6. To set the target ranges to match the current observed ranges: Store Onboard Perform with calibration Tests Clear All Ranges CL est Name Units SD / Low High Mean +/- Range / Open Stability Days / Open Stability Hours A. Select the Observed Ranges button NA AAG Acet mg/dl 1.6 1.45 0.15 208 Observed Ranges A AAT Acet Alb P g/dl 3.8 4.34 4.07 0.27 208 96.1 141 118.55 22.45 ➢ The observed QC ranges for this control, based on QC ALP Alb_G UIL 208 Alb_P ALT 28 41.3 34. 65 6.65 208 13 ALP AST UIL 35.2 54.5 44.85 data generated on this system, will display 208 13 ALTP5P Amp1K Ca mg/dl - 8.44 |10.83 208 Amp 300 Amp500 Chol mg/dl -231 265 1248 208 CL mmol/L - 92.8 104 B. Select the checkbox next to the appropriate control range Amy APOA1 198.4 5.6 208 W Crea mg/dl - 2.18 2.86 2.52 0.34 1208 APOB ASO maldi - in 30 1h 270 hnno 1hno C. Select the Copy button ? 8 Save Cancel ➢ The Edit QC Definition screen will display with the new QC Observed Ranges x Control Details target ranges Control Name Assayed Chem Control Level 1 Control Lot 14491 C Copy Test Name Low High Mean (Observed) 7. If the QC lot has been run as a parallel lot for observation, and Module Name Observed Results SD +/- Range Acet CC-05 0 will now be the primary lot, change the Usage to Primary Alb P CC-05 B O ALP CC-05 F 2 85.976 110.204 98.09 12.114 ALT CC-05 12 28.562 36.938 32.75 4.188 N 8. Select the Save button AST CC-05 13 37.805 53.733 45.769 7.964 Ca CC-05 12 12 8.332 8.884 8.608 0.276 Chol CC-05 14 232.875 242.695 237.785 4.91 CL CC-05 96.707 98.359 97.533 0.826 Crea CC-05 14 2.242 2.702 2.472 0.23 N D Bil CC-05 0 GGT CC-05 8 2 48.395 58.855 53.625 5.23 Glu_H CC-05 10 82.9 88.3 85.6 2.7 N NOTE: If the QC lot had been run as a parallel lot and was changed to primary, the Iron CC-05 0 2 operator should also edit the definition for the old primary lot and change the usage to Cancel Not in Use. 10 Effective Date: 06-APR-2020 | HOOD05162003077519 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® Solution SIEMENS Process QC Samples Healthineers Reviewing QC Needs A System Samples Inventory Calibration Patient Orders Workdist Maintenance Setup The QC Needs provides a list of the QC materials the Reagent Overview Reagent Loader Reagent Needs Supplies Overview Reagent Lot Comparison Cal-QC Storage Inventory Calibrator Needs QC Needs system requires. Name Control ID Control Lot Level Onboard Status Scheduled Usable Volume Needed (pl) Assay Storable 12345 1234 1 Not Onboard 30 Acet A QC need is created if one of following applies: 12345 1234 Not Onboard 30 ALT The QC scheduler* is set up to create an order 12345 1234 Not Onboard 30 Amm • before the end of the current day 12345 1234 Not Onboard 30 AST - 12345 12345 12345 123 12345678912 60 There is a pending QC order in the Worklist 12345 12345 12345 123 12345678912 1234567891 2 Not Onboard 30 ALT • 12345678912 1234567891 2 Not Onboard 30 C3 A need is red when there are pending QC orders in the New Control NewControl 90 New Control 2 Worklist with no QC available. NewContro NEWCONTROL Not Onboard 30 C3 NewContro NEWCONTROL 2 Not Onboard 30 Ca NewContro NEWCONTROL 2 Not Onboard 30 Carb QC Material One Controlld 57 QC Material One Controll LOTNUMBER 2 Not Onboard 28 ALT Controll LOTNUMBER 2 Not Onboard 29 Amm V Group by QC Material All QC Order ? PEP LabManager Tuesday, July 09, 2019 1:09:37 PM *NOTE: Refer to the Configuring Automatic QC Scheduling topic for more information. NOTE: If the All checkbox at the bottom of the screen is not checked, only needs for which the QC material is not available will display. This is the default setting. This topic is continued on the next slide. IM 11 Effective Date: 06-APR-2020 | HOOD05162003077519 Hardware Overview Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® Solution SIEMENS Process QC Samples Healthineers Reviewing QC Needs 1 14 A A System Samples Inventory Calibration Patient Orders Worklist Maintenance Setup To view the QC Needs: Reagent Overview Create QC Orders ration Needs 2 QC Needs X Select Assays Select Packs 1. At the Command Bar, select Inventory Name Cor Volume Needed (uL) Assay Storable Perform QC On All Analyzers Select Current Pack for All Assays Immunoassay Plus3 42 Search Select All Packs for All Assays 2. Select QC Needs Immunoassay Plus3 429 FT3 V Immunoassay Plus3 A1c_3 429 AAG AAT Assay Packs ThCG V 3. To view control material that is both onboard and not Immunoassay Plus3 429 Acet AFP aHAVM Alb Current Pack SH3UL V onboard, select All 5 Immunoassay Plus2 42 aHBs2 Alb AlbP Immunoassay Plus1 42 Aldo ALP_2 ALT 4. To group control material by control name, select Chem Lypho Level 1 26 ALTPLC Amik Amm Chem Lypho Level 2 26 Group by QC Material Amp1K Amp300 Amp500 AMY_2 Amylas APO A1 5. To consolidate the list, collapse each control name APO B ASO_2 AST using the arrow to the left of the control name ASTPL B2M BLUE Add All Assays Remove All Assays Save Cancel 6. To print the QC Needs, select the print icon in the Status bar 4 3 Group by QC Materia All QC Order ? PEP EST LabManager Monday, January 27, 2020 2:27:55 PM 6 This topic is continued on the next slide. IM 12 Effective Date: 06-APR-2020 | HOOD05162003077519 Hardware Overview Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® Solution SIEMENS Process QC Samples Healthineers Reviewing QC Needs The information displayed for each QC material includes: • Onboard status: Whether the control material is onboard or not onboard. If the status is “Onboard”, the material could be in either a Sample Handler drawer or in the Cal-QC storage area (Sample Handler configurations only) • Scheduled: When the control is automatically scheduled to be ordered • Usable Volume Needed (uL): The volume of the control required for the day • Assay: The assays associated with the control • Storable: Whether the control material is stored onboard (Sample Handler configurations only) Reagent Overview Reagent Loader Reagent Needs Supplies Overview Reagent Lot Comparison Cal-QC Storage Inventory Calibrator Needs QC Needs Name Control ID Control Lot Leve Onboard Status Scheduled Usable Volume Needed (pL) Assay Storable Sample01 12345 1234 Not Onboard 30 AAT - 12345 1234 1 Not Onboard 30 Acet 12345 1234 1 Not Onboard 30 ALT QC Material One Controlld LOTNUMBER 2 Not Onboard 28 ALT V Controlld LOTNUMBER 2 Not Onboard 29 Amm V IM 13 Effective Date: 06-APR-2020 | HOOD05162003077519 Hardware Overview Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® Solution SIEMENS Process QC Samples Healthineers Reviewing QC Needs 1 14 A System Samples Inventory Calibration Patient Orders Worklist Maintenance Setup To create orders on the QC Needs screen: Reagent Overview Create QC Orders ration Needs QC Needs 2 X Select Assays Select Packs 1. On command bar, select Inventory Name 4 Volume Needed (HL) Perform QC On All Analyzers Select Current Pack for All Assays 7 Assay Storable Immunoassay Plus3 5 Search Select All Packs for All Assays 2. Select QC Needs Immunoassay Plus3 429 FT3 V Immunoassay Plus3 429 A1c_3 AAG AAT Assay Packs ThCG V 3. Select QC Order Immunoassay Plus3 429 Acet AFP aHAVM Alb Current Pack SH3UL V Immunoassay Plus2 42 aHBs2 Alb AlbP 4. Select the appropriate analyzer(s) from drop Immunoassay Plus1 42 Aldo ALP_2 ALT down menu Chem Lypho Leve 6 ALTPLC Amik Amm Chem Lypho Level 2 Amp1k Amp300 Amp500 5. To search for an assay, enter the assay name in the AMY_2 Amylas APO A1 search field APO B ASO_2 AST 6. Select one or more assays from the table ASTPLC B2M BLUE 8 Add All Assays Remove All Assays Save Cancel 7. Under Selected Packs: • To select the in use reagent packs for the selected Group by QC Materia V All 3 QC Order analyzers, select Select Current Pack for All Assays ? PEP LabManager Monday, January 27, 2020 2:27:55 PM • To select all reagent packs onboard when 1 analyzer is selected, select Select All Packs for All Assays NOTE: The analyzer creates QC orders using the onboard QC materials for each fluid type of the defined QC material for the selected assays 8. Select Save or the oldest active offboard QC product if nothing onboard. NOTE: For more information on this topic, please refer to the Atellica Solution Online Help IM 14 Effective Date: 06-APR-2020 | HOOD05162003077519 Hardware Overview Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® Solution SIEMENS Process QC Samples Healthineers Options for Creating QC Orders • Create QC orders manually using the Create QC Orders screen ➢ Option to create orders using a panel • Configure the system to automatically create QC orders: ➢ By Day and Time ➢ By Test Count ➢ By Control 15 Effective Date: 06-APR-2020 | HOOD05162003077519 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® Solution SIEMENS Process QC Samples Healthineers Creating QC Orders Manually Atellica Solution Version 1.14.0.2963002 SP00107 K 1 E 1. At the Command Bar, select QC System Samples Inventory Patient Orders Worldnet Maintenance Setup 2 Create QC Orders Control Bracketing Of Statistics Patient QC Furggino QC Definitions QC Parais Qc Schedider 2. Select the Create QC Orders tab Contral Matenals Control Name Level Control Les Conmul Lot Expiration Ceboard Usage 4 3. Select the tests to be ordered 3 MAPLUS 2 1100/2019 Present Select Tests + WPLUS3 40343 40500 1100/2019 Present prmary Module Tipe • The tests displayed can be filtered by Module Type if Search the Atellica Solution has more than one type of analyzer AFP ALT Orders connected X Condi Name Level Control ID Lo Expiration Slack D/ Postos) X Test Name Reglicates / System Test Options AST CEA 5 X MAPLUS 1 40041 40341 11/02019 Present + X FSH • The Search field can be used to locate a test name DJCK 4. If the selected test has multiple control materials defined, LDUP the control materials will appear in the Control Materials area of the screen. Select one or more materials to include TP in the QC order. Once selected, the control test orders will appear in the Orders area of the screen 6 Select Panels Save Refresh If the selected test only has one control material defined, ? PER B & LabManager Thursday, May 31, 2018 2:41 PM the control test order will appear in the Orders area of the screen as soon as the test is selected NOTE: To associate controls with QC orders, the controls must be defined in QC Definitions. 5. Make any edits to the tests ordered, replicates, or analyzer the tests will be run on* * See the next slide for more information on the Orders section of the screen 6. Select Save 16 Effective Date: 06-APR-2020 | HOOD05162003077519 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® Solution SIEMENS Process QC Samples Healthineers Creating QC Orders Manually (continued) NOTE: There is a difference in how the result is reported In the Orders section of the Creating QC Orders screen, the following edits can be made to the for tests ordered as duplicates (using the + icon) versus orders: tests ordered as replicates (using the Replicates Select the + icons to create duplicate orders of the test dropdown): A. Duplicates: The individual results for each order will be B. Select the X icons to delete tests or controls reported C. Select the replicates dropdown arrow to change the number of replicates for that order Replicates: Only the mean result will be reported Orders Instrument Test Options X C X Control Name Level Control ID Control Lot Lot Expiration Usage Onboard Rack ID / Position X Test Name Replicates / System Test Options / Test Name CA125 2 Module N-8-6 X IA PLUS 1 1 40341 40341 11/30/2019 Primary Present + X FSH » Edit Test Options 1 Lot - A B Primary Pack D. If the Atellica Solution has multiple modules of the same type of analyzer connected (more than one Ancillary 1 Pack chemistry analyzer for example), the specific analyzer that the order will be run on can be defined: Ancillary 2 Pack 1. Select Edit Test Options Diluent Pack 2. Select the analyzer using the Module dropdown list. If desired, the reagent lot or specific reagent pack can also be specified ? Clear All 3 OK Cancel 3. Select OK NOTE: If you do not specify an analyzer, an order will be created on all the analyzers that have that test. 17 Effective Date: 06-APR-2020 | HOOD05162003077519 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® Solution SIEMENS Process QC Samples Healthineers Ordering QC Panels SIEMENS P-P1-0 Krollhinters Atellico Solution Version 1.14.0.2963002 160 1 A QC Panel is a collection of tests or QC materials, allowing System Samples Calibrabon Toc Patient Orders Workdest Maintenance Setup 2 Greata OC Orders * Control Bracketing QC Definition QC Panels QC Scheduler you to add a defined group of tests or QC materials to a QC Select QC Panels x order without selecting the tests or QC materials individually. 4 Panels Panel Name - Panel Status: Priority Next Expiration Date Date Last Modified To order a QC Panel: Select Tests DailyQC In Use Routine 11:30:2019 11/30/2017 Module Type DailyQCCH In Use Routine 2/29/2020 11/27/2017 Search At the Command Bar, select QC In Use Routine 11/27/2017 1. DAILYQCIM 2. Select the Create QC Orders tab Finelades / Sysbim Test Opbons AST CEA 5 Orders 3. Select the Select Panels button Control Name Control ID Control Lol Lol Expiration Usage Oriboard Test Name Module Reagent Lot Replicato WPLUS 1 40341 43343 11/30/2019 Prienary Present Dig 4. Select the panel(s) to be ordered FEM FT3 TSH3UL Thee IA PLUS 2 40342 40342 11/30/2019 Primary Presen The control materials and tests associated with the Dg 5. F13 selected panel(s) will display in the Orders area of the TSHOUL R screen ? 6 Select Cancel Select Panems Retres 6. Select the Select button 3 8 ? PEPB LabManager Thursday, May 31/ 2018 2:41 PM 7. Make any edits to the tests ordered, replicates, or analyzer the tests will be run on 8. Select the Save button to create the orders 18 Effective Date: 06-APR-2020 | HOOD05162003077519 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® Solution SIEMENS Process QC Samples Healthineers Configuring Automatic QC Scheduling LEMENS Healthingers Atellico Solution Version 1.14.0.2963002 P.P1-0 QC samples can be scheduled according to day and time, Samples Inventory Calibration 1 System Patient Orders Work ist Maintenance Setup test count, or control. Create QC Orders Control Bracketing QC Statistics Patient QC Flagging QC Definitions QC Panels 2 QC Scheduler By Day and Time To configure QC to be automatically scheduled: Sunday Monday Tuesday Wednesday Thursday Feday Saturday 3 By Test Count Copy Day 1. At the Command Bar, select QC By Control 2. Select the QC Scheduler tab Set Waming 3. Select the appropriate scheduling type: By Day and Time – By Test Count – By Control – 4. Select the Add Schedule button The Add Schedules screen for that scheduling type will 4 Add Schedule display. ? Thursday, May 31, 2018 2:41 PM NOTE: To edit an existing QC schedule, on the QC Scheduler screen, select the QC schedule to edit and then select the Edit/View button. Make the necessary edits and select the Save button. *This procedure is continued on the following slides with the specific procedures for configuring each scheduling type. 19 Effective Date: 06-APR-2020 | HOOD05162003077519 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® Solution SIEMENS Process QC Samples Healthineers Configuring Automatic QC Scheduling – By Day and Time Add Schedules X This setting configures the system to automatically create QC orders at a 1 Module Type CH set day and time each week. Schedules QC 4 To configure QC to be automatically scheduled by day and time, on the All Days 2 Definitions & Panels Details Add Schedules screen: Sunday Assay Chem Control 14491 1. Select a module from the Module dropdown list to filter the list of QC Monday Assay Chem Control 14492 materials displayed Tuesday Chem Panel 1 2. Select the days as appropriate Wednesday ETOH-1 54141V 3. Select the double right arrows under Select Time to select time Thursday ETOH-2 54142V periods Friday ETOH-3 54143V ➢ After the time period is selected, select the double left arrows Saturday to return to the Add Schedules screen Select Time 4:00 AM 4. Select a control set 3 ➢ To view details about the available control sets, select the double right arrows next to each set 5. Select the Save button ? 5 Save Close The QC schedule will display on the QC Scheduler screen. NOTE: For Sample Handler configurations only: On the QC Scheduler screen, the Set Warning button can be used to activate a warning message if the onboard control is not available at a specific amount of time before the scheduled QC order. 20 Effective Date: 06-APR-2020 | HOOD05162003077519 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® Solution SIEMENS Process QC Samples Healthineers Configuring Automatic QC Scheduling – By Test Count Add Schedules X This setting configures the system to automatically create QC orders after a set Test Settings QC 4 number of tests are run. 1 Module Type CH Definitions & Panels Details To configure QC to be automatically scheduled by test count, on the Add Tests 2 Assay Chem Control 14491 Schedules screen: H L Assay Chem Control 14492 - 1. Select a module from the Module dropdown list to filter the list of QC NA K CL V Chem Panel 1 materials displayed AAG AAT Acet 2. Select the necessary test(s) Alb_G Alb_P ALP ALT ALTP5P Amm ➢ If multiple tests are selected, the test count will be cumulative across those tests Amp1K Amp300 Amp500 Amy APOA1 APOB 3. Enter a Set Count ASO AST ASTP5P ➢ The Current Count for the selected test(s) displays below the Set Count B2M Bnz200 Bnz300 4. Select a control set Test Count 3 Set Count 100 ➢ To view details about the available control sets, select the double right Current Count 0 arrows next to each set 5. Select Save ? 5 Save Close The QC schedule will display on the QC Scheduler screen. NOTE: For Sample Handler configurations only: On the QC Scheduler screen, the Set Warning button can be used to activate a warning message if the onboard control is unavailable at a specific percentage of the scheduled test count. 21 Effective Date: 06-APR-2020 | HOOD05162003077519 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® Solution SIEMENS Process QC Samples Healthineers Configuring Automatic QC Scheduling – By Control Add Schedules X This setting configures the system to automatically create QC 1 Module Type CH orders when the corresponding control material is loaded on Control Material 2 QC 3 the system. Control Name Control Level Control ID Control Lot Control Lot Exp Usage Definitions & Panels Details This feature is useful for controls used for tests that perform Assay Chem C ... 1 K14491 14491 11/30/2017 11:. Primary Assay Chem Control 14491 intermittently, and applies only to manually loaded controls. Assay Chem C ... 2 K14492 14492 11/30/2017 11: ... Primary Chem Panel 1 ETOH-1 1 K54141V 54141V 09/30/2017 11: ... Primary To configure QC to be automatically scheduled by test count, ETOH-2 2 K54142V 54142V 09/30/2017 11: ... Primary on the Add Schedules screen: ETOH-3 3 K54143V 54143V 09/30/2017 11: ... Primary 1. Select a module from the Module dropdown list to filter the list of QC materials displayed 2. Select the control name ? 4 Save Close 3. Select a control set ➢ To view details about the available control sets, select the double right arrows next to each set NOTE: For Sample Handler configurations only: This feature should not be used if the controls are stored in the cal/QC storage area. 4. Select Save The QC schedule will display on the QC Scheduler screen. 22 Effective Date: 06-APR-2020 | HOOD05162003077519 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® Solution SIEMENS Healthineers Process QC Samples P-P1-03 SIEMENS . QC Barcodes Healthineers Atellica® Solution Version 1.14.0.2963002 1 Samples Inventory Calibration ac Patient Orders Worklist Maintenance Setup QC barcodes must be printed using the Atellica Solution Qc Statistics Patient QC Flagging 2 Create QC Orders Control Bracketing QC Definitions QC Panels QC Scheduler software to ensure that each barcode has the correct sequence Filter. Y Status: All number. Control Level Control ID Control Lot Control Lot Expiration Usage Specimen Type Date Last Used Edit/View. Control Name URINE TOX 3 3 UT3 66220 08/31/2018 Primary Urine 06/05/2018 Copy To print QC barcodes: 3 UT2 66220 08/31/2018 Primary Urine 06/05/2018 URINE TOX 2 URINE TOX 1 UT1 66220 08/31/2018 Primary Urine 06/05/2018 Delete Urine Chemistry2 2 42766792T 66792T 12/31/2018 Primary Serum 05/29/2018 1. At the Command Bar, select QC Export .. Urine Chemistry1 42766791T 05/29/2018 667911 12/31/2018 Primary Serum TM PLUS3 3 54633 54633 09/30/2019 Priman Serum 01/18/2018 4 Print Barcode ... 2. Select the QC Definitions tab TM PLUS2 01/18/2018 2 54632 54632 09/30/2019 Priman Serum TM PLUS1 1 54631 54631 09/30/2019 Priman Serum 01/18/2018 Primary Serum 07/30/2018 3. Select the checkbox(es) for the Control Name(s) to print sBNZ Control 3 3 BNZ3 TOX1801M 01/31/2019 SBNZ Control 2 2 BNZ2 TOX1801M 01/31/2019 Primar Serum 07/30/2018 SBNZ Control 1 BNZ1 TOX1801M 01/31/2019 Primary Serum 07/30/2018 4. Select the Print Barcode button IA PLUS 3 3 40353 40353 05/31/2020 Primary Serum 07/31/2018 LA PLUS 2 07/31/2018 2 40352 40352 05/31/2020 Primary Serum The barcodes will print to a local barcode printer, or to a IA PLUS 1 40351 40351 05/31/2020 Primary Serum 07/31/2018 HBSIPOS POS632 06/03/2018 Serum 03/29/2018 2 6315472 Priman networked barcode printer shared with the system. HBsll Nog NEG631 631547 06/03/2018 Priman Serum 03/29/2018 HAVM POS 2 HAVPOS 701038 04/13/2018 Primary Serum 10/03/2017 L ....... ...... QC Orders .. Import Add QC Definition ... ? PEP LabManager Tuesday, July 31, 2018 11:58:26 AM NOTE: Some QC manufacturers will provide pre-labeled QC tubes. NOTE: For the Sample Handler configuration, all tubes must be barcoded. For the Direct Load configuration, tubes may be run either barcoded or non barcoded. 23 Effective Date: 06-APR-2020 | HOOD05162003077519 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® Solution SIEMENS Process QC Samples Healthineers P-P1-05 Viewing Test Orders and Results SIEMENS Healthingery Atellico" Solution Version 1.14.0.2963002 1 Workfest Setup System Samples Inventory Calibration Patient Orders Maintenance The Worklist Overview screen can be used to view the status 2 Worklist Overview Monitoring Lab Metrics of test orders and results for calibration, QC, and patient Sort By Name Teils Count 25 Filter Y Tiene: 24 Hours: 4 Sample orders. Order Date 24 Hours Nome Test Interpretation Flags 3 Sample Type 45701 biorad chol 2 117 mg/dl Adt Tratti Dich To view test orders and results: 45701 biorad LA 3 3 mg/d. Analyzer 457.01 biorad Chol 117 mg/dl Sample Test Custom biorad GhH 217 mg/d. 1. At the Command Bar, select Worklist 45701 Ordered biorad JA 12 mg/dl 45701 VanG 2. Select the Worklist Overview tab X Inprocess biorad 45702 biorad 2 Chol 2 191 moi Intervention Needed 45702 biorad 2 3. The Filter area of the screen is used to filter the orders Completed 45702 blorad 2 KC Transmitted 25202 siorad 2 VanG 175 ugin Test displayed. Under Sample Type, QC can be selected Load List 457.52 Sorad 2 45702 iorad 2 62 mgld 4. The Orders area of the screen displays the result time for O Watch List Biocad3 Biorad3 JA 10 0 mg/dl inprocess test orders, and the result value and units for Borado Chol 2 300 mold Biorad3 > Measuring Interval resulted test orders View Samples 80 mg/l. Dride Jet Query US lenport worldint Statistics Export ? PEP LabManager 500 Thursday, May 31. 2018 2:41 PM * See the next slide for more information on the Worklist Overview screen 24 Effective Date: 06-APR-2020 | HOOD05162003077519 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® Solution SIEMENS Healthineers Process QC Samples P-P1-037 Viewing Test Orders and Results (continued) HEMENS Healthingers Atellico Solution Version 1.14.0.2963002 System Samples Inventory Calibration Oc Patient Orders Working Maintenance Setup 5. Selecting one of the Flags symbols will display a list of Worldlist Overview Monitoring Lab Metrics what the symbols mean. Scroll down to the bottom of the Sample Type Control _Time: 24 Hours : Sort By Name Tests Count: 18 Filter Sample list to view the low and high limits that are defined in the Order Date 24 Hours SID Nonte Test Reju Interpretation Flags Sample Type Control 45701 Siorad hol 2 QC Definition screen for that control 45701 blond UA 3.3 mod Analyzer 45701 blond Chol 2 112 mg/dl. Stat Watching Sample Teet Custom 45.201 bloead De Wachtg Saved Fiters 45701 biorad No Filter 45.701 biorad VanG Advanced Faters 45.702 biorad 2 Chol 2 biorad 2 5 45702 biorad 2 45702 bicirad 2 Vans Result 572 mg/dl Test 45.702 blorad 2 Chol 2 High 45702 biorad 2 SEA Biorad3 Chol 2 Biorad Colbieal High Concert Biorad Chol 2 Catical Low Biorad > Measuring Interval 100 + 114 Eliorad3 Query US Import workint Statistics Export ? PEP. BR LabManager Thursday, May 31/2015 2 41 PM 25 Effective Date: 06-APR-2020 | HOOD05162003077519 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® Solution SIEMENS Monitor QC Results Healthineers Viewing QC Data – Review screen SIEMENS Heat Atellica Solution Version 1.14.0.2963002 P-P1-04 1 A Samples Inventory Calibration Patient Orders Work fest Maintenance Setup The QC Statistics screen provides real-time and long-term Create QC Orders 2 Control Bracketing QC Statistics Patient QC Flagging QC Definitions QC Panels QC Scheduler evaluation of system and assay performance. 3 Review Messages Tools C Show by @ Control Test Show Results Unreviewed Out of Control Warning Mother B The Review screen displays current QC results. A Severity Date AnabyDRE SN Tet Level Lot Retult z Target # 250 Comment Doduded Review 11/29/2017 1:43PM4 3900107 00109 LA PLUS wWml Comment To access the QC Review screen: TSHJUL 09109 11/29/2017 3:46 PM4 5900107 00100 -2 14:2647 - 18.7- Analyze 14.15 co2_ 11/29/20171:46 PM4 3200107 00109 LA PLUS 1 1 49341 (25) 2.144 2.0 0.1553-0.5207 1. At the Command Bar, select QC - - ThCG LA PLUS : 49343 - 11/29/2017:3:45 PM4. 5000127 09100 CEA TM PLUSZ 2 54612 4.2 17.438 -28.234 2. Select the QC Statistics tab 11/29/2017 1:45 PM4 9900107 09109 LA PLUS 2 2 49342 11/29/2057 3:48PM 5000957 AFP LA PLUS 1 :1 48341 HAVMA 11/29/2057 3:44784 5000507 00109 TM PLUS 54633 249.4 -2.1 251-3333 - 308. 3. Select the Review tab 11/29/20173:36 PM 3900007 Chen co. 2 26472 14.9 -2-3 15.4147- 23.0. ALD 2e CMOON13 Chen co ... 15.1 -2.4 15.4167- 13.4_ Areas of the screen: AST A. Control file selection – contains options for selecting the Chol_2 CL control files to be viewed Crea_ 2 B. Filters – used to filter the types of files displayed Select Expand All Auto- select Iss Select 11 results, 1 selected Reports Customize ? PEP LabManager Thursday, May 31, 2018 2:41 PM C. Functions – used to mark files as reviewed, add comments, and analyze files to create QC graphs and statistics IM 26 Effective Date: 06-APR-2020 | HOOD05162003077519 Hardware Overview Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® Solution SIEMENS Monitor QC Results Healthineers Viewing QC Data – Review screen – QC File Selection Review Analysis Messages Show by Control On the left side of the Review screen, select the control files to be viewed. When a control OTest Show file is selected, the corresponding QC results will be displayed in the table on the right Test Severity A Leve Date side. CEA 11/29/2 X TSH3UL 11/29/2 X • The control files can be listed by Control or by Test AFP 11/29/2 CO2_c 11/29/2 • Buttons at the bottom of the screen: ThCG 11/29/2 A. Select: options to Select All or Deselect All Dig 11/29/2 HBsIl B. Expand All: to display all the control files listed under each control or test 11/29/2 A1c_3 0 11/29/2 C. Auto-select Issues checkbox: to automatically select any control files that are out aHAVM 11/29/2 of range, in violation, or omitted Alb 11/29/2 ALP_2c 11/29/2 ALT AST Ca Chol_2 CL Crea_2 IIII Select Expand All Auto-select Iss Select A B C IM 27 Effective Date: 06-APR-2020 | HOOD05162003077519 Hardware Overview Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® Solution SIEMENS Monitor QC Results Healthineers Viewing QC Data – Review screen – Filters Messages Tools Setup A Show Results Unreviewed B Out of Control Warning Other Date System Analyzer SN Analyzer Name Test Control Level Lot QC Violation Result Unit Z Target + 2SD Comment Excluded Reviewed Review 11/29/2017 3:48 PM SP00107 1H00109 00109 TSH3UL IA PLUS 3 3 40343 [35] 12.887 ulU/mL -4.1 19.5333 - 32.2 ... Comment M 11/29/2017 3:47 PM SP00107 1H00109 00109 TSH 3UL IA PLUS 2 2 40342 [35] 2.392 ulU/mL -3.9 3.4833 - 5.8167 Analyze 11/29/2017 3:46 PM SP00107 IH001 09 00109 CEA IA PLUS 2 2 40342 [25] 14.25 ng/ml -2 14.2667 - 18.7 ... Use the filters at the top of the screen to filter the control results to be displayed: A. Show Results dropdown – options are Reviewed, Unreviewed, and All • Reviewed results are results that have been designated as “Reviewed” • There is a configuration setting to have all control results that are within range be automatically designated as “Reviewed”. Refer to the Atellica Solution Online Help for more information on QC settings • The operator can manually designate results as “Reviewed” by using the Review button B. Checkboxes – select to display results that are Out of Control (red), have a Warning (yellow), or Other results (results outside the trim limits) IM 28 Effective Date: 06-APR-2020 | HOOD05162003077519 Hardware Overview Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® Solution SIEMENS Monitor QC Results Healthineers Viewing QC Data – Review screen – QC File Selection Messages Tools Setup Show Results Unreviewed out of Control Warning Mother In the main area of the screen, the details of each control A Date V |System Analyzer SN Analyzer Name Test Control Level Lot QC Violation Result Unit arget + 2SD Comment Excluded Reviewed Review N result are listed. 11/29/2017 3:48 PM SP00107 1H00109 00109 TSH3UL IA PLUS 3 3 40343 [35] 12.887 JIU/ml 4.1 19.5333 - 32.2 ... Comment B 11/29/2017 3:47 PM SP00107 IH00109 00109 TSH 3UL IA PLUS 2 2 40342 2.392 ulU/mL -3.9 3.4833 - 5.8167 K Yellow indicates a result with a warning 11/29/2017 3:46 PM SP00107 IH00109 Analyze • CEA IA PLUS 2 2 40342 [se] 00109 [25] 14.25 ng/ml -2 14.2667 - 18.7 ... C 11/29/2017 3:46 PM SP00107 IH00109 00109 TSH 3UL IA PLUS 1 40341 [25] 0.194 ulU/mL -2.9 0.2553 - 0.5207 • Red indicates a result that is out of control 11/29/20173:45 PM SP00107 IH00109 00109 AFP A PLUS 3 40343 [25] 182.7 ng/mL 2.3 186.3333 - 237 ... 11/29/2017 3:45 PM SP00107 IH0010 00109 CEA TM PLUS2 . 54632 [35] 16.66 ng/ml 4.2 17.938 - 20.234 • Blue indicates a non-numeric result, system excluded 11/29/2017 3:45 PM SP00107 IH00109 00109 AFP A PLUS 2 2 40342 [25] 85.5 ng/mL 2.8 90.1 - 113.9 data point 11/29/2017 3:44 PM SP00107 IH00109 00109 AFP A PLUS 1 1 40341 [25] 14.9 ng/ml 3 16.2333 - 21.5 ... 11/29/2017 3:44 PM SP00107 1H00109 00109 ThCG TM PLUS3 3 54633 [25] 249.4 IU/mL 2.1 251.3333 - 308 ... To perform a function on a result, select the result and then 11/29/2017 3:36 PM SP00107 CM00110 CM00110 CO2_c Chem co ... 2 26432 [25] 14.9 mEq/L -2.5 15.8167 - 23.0 ... 11/29/2017 3:36 PM SP00107 CM00113 CM00113 CO2_c Chem co ... 2 26432 [25] 15.1 mEq/L 2.4 15.8167 - 23.0 ... select a function button: A. Review: to designate an out of range and warning result as “Reviewed” B. Comment: to add a comment to a data point C. Analyze: to view graphs and statistics for the data S Select 11 results, 1 selected Reports Customize ➢ Select Analyze to open the Analysis screen with the QC chart displaying all data points for the selected control files IM 29 Effective Date: 06-APR-2020 | HOOD05162003077519 Hardware Overview Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® Solution SIEMENS Monitor QC Results Healthineers Viewing QC Graphs and Statistics – Analysis screen The Analysis screen provides graphical and tabular views of the data selected in the Review window or the Filter window. This screen can be used to analyze QC and patient data, and evaluate errors. There are 3 tabs within the Analysis screen: • Chart – displays a Levey-Jennings or Z-score graph of the selected data • QC – displays detailed information for the control files currently displayed in the Chart tab • Patient – detailed view of individual data points in the patient median or mean data file Create QC Orders Control Bracketing QC Statistics Patient QC Flagging QC Definitions Review Analysis Messages Tools Setup Filter ... 8/9/2017 3:47 PM - 11/29/2017 3:47 PM Chart QC Patient 2 TSH3UL(ulU/mL), IA PLUS 2, Level: 2, Lot#: 40342, Analyzer SN IH00109, Analyzer Name 00109 30 Effective Date: 06-APR-2020 | HOOD05162003077519 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® Solution SIEMENS Monitor QC Results Healthineers Viewing QC Graphs – Analysis screen Atellico Solution Version 1.14.0.2963002 P-P1-04 Select the Analysis screen Chart tab to display a graph of the data: System Samples Inventory Caltrion Pabert Orders Workfind Martenance Setup Create QC Orders Contrel Bracketing QC Statistics Patient QC Flagging QC Definitions OC Panels Qc Scheduler 1. Select the Display dropdown list to select whether to view Messages Tools Levey-Jennings charts or Z-score charts 2 1/9/2007 3:47 PM - 11/29/2017 2:47 PM Chart 6 roujulimc), LA PLUS 2, Level 2. Leor: 40962, Analyze SH 9-100107, Analyzer Name 00109 Jedes • The Levey-Jennings chart marks the mean and first, second, and third standard deviation (SD) limits on the Y-axis 4 include 6.400 5 Comment • When the Z-score chart is selected, the graphs from multiple 6417 Qc Dital control files can be overlayed 2. Select the Filter button to apply a date or time range to the data 4.007 • Another option to change the time range is to use the scale 2.900 beneath the chart 3. Select the Statistics button to view statistics for the data -- 1 displayed Refresh 4. Select the Exclude button to remove a data point from the ? PEP LabManager 3 May 31, 2010 2:41 PM statistical calculations. The excluded point will be displayed in the chart and will not be connected to the other data points NOTE: When a control file has more than 1 target, the system displays the original and the changed target value, resulting in an offset view. • The Include button can be used to reinstate excluded points for statistical calculations 5. To add a comment to a data point, select a data point and then select the Comment button 31 Effective Date: 06-APR-2020 | HOOD05162003077519 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® Solution SIEMENS Monitor QC Results Healthineers Viewing QC Graphs – Analysis screen (continued) Chart QC Patient There are symbols on the Chart that identify out of range 2 Mg(mg/dl), Assay Chem Control, Level: 2, Lot#: 14492, Module Serial #: PP-CC-03, Module Name: CC-03 View results, and indicate various system events that may impact QC B ... ... results: A. Data points are denoted with “2S” or “3S” if the point is 5.00 outside 2SD or 3SD 4.86 B. Information symbols at the top of the chart provide information on when calibrations were performed and when 4.72 reagent lot changes occurred 4.59 C. Blue symbols at the bottom of the chart provide information 4.45 on events that occurred on the system 4.3116 125 4.17 A C 10/16/2016 10/23/2016 10/30/2016 11/06/2016 11/13/2016 11/14/2016 Display: Levey-Jennings SV Overlay Scale: 1.1 Months 32 Effective Date: 06-APR-2020 | HOOD05162003077519 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® Solution SIEMENS Monitor QC Results Healthineers Viewing Statistics – Analysis screen Statistics To view statistics for a selected QC data set: Current: Time frame 1: Time frame 2: 1. Navigate to QC > QC Statistics > Analysis > Chart 10/25/2016- 11/10/2016 10/01/2016- 10/31/2016 11/08/2016- 11/15/2016 2. Select the Statistics button QC Patient The Statistics window displays four sets of information for each ALP(U/L), Assayed Chem, Level: 2, Lot#: 14492, Module Serial #: PP-CC-05, Module Name: CC-05 selected file: Target Current Time frame 1 Time frame 2 Target - Displays the target mean, SD, and percent CV (as Target Mean 468 Mean 384.3 Mear 376.2 Mean 391.6667 • 24 1SD 12.553 1SD 2.082 defined in the QC Definition screen) Target 1SD 1SD 13.312 Target %CV 5.13 %CV 3.27 %CV 3.54 %CV 0.53 • Current - Displays statistics for the control over the time n(Included) 10 n(Included) 5 n(Included) n(QC Violations) 10 3 interval currently defined in the Analysis window n(QC Violations) 5 n(QC Violations) • Time Frame 1- By default, an interval of time equal to that displayed in the Current panel and immediately prior to the current panel • Time Frame 2 - By default, the statistics for the previous six ? Customize Close months from the current time NOTE: Both Time Frame 1 and Time Frame 2 can be changed by selecting the Time frame buttons at the top of the window. 33 Effective Date: 06-APR-2020 | HOOD05162003077519 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® Solution SIEMENS Monitor QC Results Healthineers Viewing QC Data – Analysis screen SIEMENS Atellica" Solution Version 1.14.0.2963002 P-P1-04 Selecting the QC tab within the Analysis screen displays a to System Samples Inventory Calibration Patient Orders Work leid Maintenance Schup table of the data currently displayed in the Chart tab: Create OC Orders Control Bracketing QC Statistics Patient OC Flagging QC Definitions QC Panels QC Scheduler Redew Analysis Messages Tosh Setup 1. Each row of the table represents a data point that is 2 ESter ... 8/9/2017 3:47 906 - 11/29/2097 3:47 PM currently displayed in the chart. The scroll bar at the Chart Patient 1 P. System Analyzer Mamie Tel Congral Level Lot QC Violation Veit Target # 250 Comment Exduded Review Date Fle Suo Severity bottom of the table can be used to view the details for Cxdude 1/28/2017 3:47 PM 5000107 TA PLUS 1 40347 Out of C. Pr 11/26/2017 10:37 AM 5700107 IM00109 001-29 IA PLUS 2 40342 2.301 4 3.4833-5.8167 18/29/2017 3:07 PM Ope Quef C. Py include each data point 11/28/20179:24 AM -5900107 1H00109 00109 2 48342 2.300 4.3.4822-5.8167 11/29/20179:06 AM Open Out of C. Prla Comitent 11/28/2017 3:47 PM 5000107 IN00100 09129 LA PLUS 2 2 49342 2.118 11/29/20178:22AM Opet Out of C. Pdf Select the Filter button to apply a date or time range to 11/28/2017 10:16 AM SP00107 TA PLUS 2 14 3.4833 .5.8167 11/29/2017 8:23AM Open Out of C. Prf QC Details 2. 1H00109 09199 C2 20342 11/17/2017 3:15 PM 5200107 1900109 00109 IA PLUS 2 2 40342 2.502 -3.7 3.4833 - 5.8167 11/27/2017 18:12 AM Open Out of C. P the controls displayed 11/12/2017 12:45 PM 5P00107 1H00109 00100 IA PLUS 2 2. 40342 1.303 -5.7 3.4833 -5.8167 11/22/2017 19:12 AM Open 11/87/2017 11:16 AM SP00107 1H00109 00109 LA PLUS 2 1,207 -5.7 3.4833-5.8167 11/27/2017 18: 12 AM Open Out of C. Prf 11/14/20172:16 PM 5000107 1H00100 LA PLUS 2 2 40342 [xs.] 1.259 .5.8 3.4833 -5.8167 CS 11/14/2017 2:26PM Open Out of C. Pr • Another option to change the time range is to use 11/13/20175:17PM SP00107 IN00109 00109 LA PLUS 2 2 40342 -5.9-3.4833 -5.8167 CS 11/16/2017 1101 PM Ope Out of C. Pch the scale beneath the chart 11/10/2017 2:56 PM SP00107 IM00109 00129 LA PLUS 2 2-40342 1.323 -5.7 3:4823 - 5.8167 LabManag. 11/10/2017 3:24PM Open Out of C. P 11/10/2017 11:15AM SP00107 1H00100 00109 TSHJUL IA PLUS 2 2. 40342 4.190 -0.0 3.4833-5.8167 System 11/10/2017-11:15 AM Open is Control Prie 11/9/20172:48 Pal SP00107 001.29 IA PLUS 2 1 40342 4.209 -0.0 3.4832-5.8167 System 1129/20172:48 PM open In Control Pra 11/9/2017 11:16AM 5800107 1H00100 00120 TSHJUL MA PLUS 2 2 4034 4.812 WWWL 0.3 3.4833 -5.8767 Systems 11/9/2017 AHIT6 AM Open in Control Pyh 11/8/20178:58AM 5900107 IN00109 00109 4,918 0.5 3.4832 -5.8167 Stem 11/9/2017 5:58 AM Oon In Control Prir 25 results, 1 selected @ Bins, 0 selected Reporti ? PEP LabManager Thursday, Stry 31, 2018 2:41 PM NOTE: The columns displayed can be customized in the Setup screens. 34 Effective Date: 06-APR-2020 | HOOD05162003077519 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® Solution SIEMENS Monitor QC Results Healthineers Using Patient Data for QC Statistics The Patient Median and Patient Mean features provide additional tools within QC Statistics to help monitor the performance of the system and troubleshoot systematic errors. The operator can collect patient result data on 1 or more analyzers in the configuration and use the data to perform QC for selected tests. To enable the monitoring of patient data for QC Statistics: 1. Navigate to QC > QC Statistics > Setup > Patient 2. Select a test (each test enabled for each Module Name has a separate entry) 3. To define the upper and lower limits for Patient Median and Mean analysis, specify an Upper Trim Limit and Lower Trim Limit 4. To define reference lines to display with patient sample QC data, specify Upper Line, Lower Line, and Ref Line 5. Select the Active checkbox to turn on data collection for the test on the specific analyzer 6. Select Save To view the patient control data: 1. Navigate to QC > QC Statistics > Analysis > Patient 2. View the data displayed for each average data point: Includes the date when the point was calculated, the data point, the test, and the analyzer 3. To view statistics for the data displayed, select the Statistics button 35 Effective Date: 06-APR-2020 | HOOD05162003077519 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® Solution SIEMENS Monitor QC Results Healthineers Patient QC Flagging Atellico" Solution Version 1.14.0.2963002 SP00107 E The Patient QC Flagging feature allows you to configure the system to System Sarroles Mitverbory Calexation Patient Orders Woddel Mantervince Setup flag patient results based on QC error rule violations. Create DC Ondars Patient QC Fisaging DC Schedules • To enable Patient QC Flagging, navigate to QC > Patient QC Flagging. Whole Boo Select a test and then select Edit/View. Select Automatic or Manual, MO - and then select Save Patient OC Flagging : AAG x • If a QC result triggers an alert that has been configured in the QC Semm Statistics > Setup > QC Rules screen, the system will start flagging patient results for that test ? Circel ➢ On the Worklist Overview screen, the A flag displays for patient test results indicating that a QC violation error occurred S for at least one level ALIFE ALTPLE • Once the flagging has initiated for a test, the flagging is cleared by 100000000000000000000 one of these methods, depending on the configuration settings: ? Labilitanager Thursday, May 31, 2018 2 41 PM & Automatic: Patient QC Flagging is reset automatically after the QC levels that previously failed produce passing results OR Manual: Patient QC Flagging is reset when the operator selects the Clear Patient QC Flagging button on the Patient QC Flagging screen • When Patient QC Flagging is cleared, all patient results that had been 36 flagged will stay flagged, new results will not be flagged Effective Date: 06-APR-2020 | HOOD05162003077519 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® Solution SIEMENS Generate QC Reports Healthineers Printing QC Data SIEMENS Atellica" Solution Version 1.14.0.2963002 SP00107 1. At the Command Bar, select QC 1 System Samples Inventory Calibration Patient Orders Worklingt Maintenance Create QC Orders 2 Control Bracketing QC Statistics Patient QC Flagging QC Definitions QC Panel Definitions OC Scheduler 2. Select the QC Statistics tab Review 3 Analyin Menages Toola Module Names - Show Results All 3. Select either the Review or Analysis tab Show by Control 2 Test out of Control Warning Other Dala System module Serial # module Name Tes Cerare Level Qc Violation Result Target # 230 Comment Endude Review Aday Cham C. WL Comment 4. Select Reports Assay Chem C. $4.00 WL 3.3 103.5637 - 133.5167 11/10/20168:37:1- 06-01 PP-CC-93 cc-03 Anay Chem C 2 1449 Isc ] 141.00 -32 420 -514 Analyze There are several report options: cc-01 ALD Astay Chem C .. 103.00 -2.1 101.5833- 133.5167 ket 11/07/201630047: 26-01 PP.CC.43 Assay Chem C .. 1 14491 83.00 2.4 103.5833 - 133,5967 Y ALP PP-CC-03 CC-03 ALD Anay Chem C. 373.00 -4 420.516 • Monthly Report 11/04/2016 12:15.6-0 ANsay Chem C .. 1 14491 $15.00 0.5 143.5833 + 133.5167 LAST 11/06/2006 12:14: 56-01 PP-CC-03 Cc-03 Ariay Chem C. : 14482 183.00 -2.5 420 -516 PP-CC-43 Cc-83 Assay Chem C. 2 14482 425.00 2.6 428 . 516 • Exception Report E Chd AMay Chem C 156.00 0.3. 103.5833 - 133.5167 11/03/2006 10:072 DL-01 PP-CC-03 Assay Chem C 1 14499 113.00 0.7 102.5633-133.5167 Assay Chem C. 450.00 -2.4 420 - 516 • Summary Report PP.CC-43 PP-CC-43 CC-03 Aviay Chm C 2 14492 422.00 -2.8 420 -516 11/02/2006 11:38: 00:41 PP.CC.41 AU Assay Chem C. 1 14495 WL -0.4.103.5833 - 133.5167 • Patient Median Report PP-CC.03 CC-02 Astay Chem C. 2 14492 494.00 -2.7 426 -516 11/01/22:68:033 00:01 W-CC-4) Cc-03 Assay Chem C. 112.00 -0.9 103.5833 - 133.5167 CC.03 492.00 -1.4 40-514 • Custom Report bron PP.CC-43 ALP Away Chem C. 2 14892 WL Select Expand All Auto select Ist Select 22 result. @ selected ? 4 Reports Customize ? PEP LabManager Thursday, May 31, 2018 2 41 PM 37 Effective Date: 06-APR-2020 | HOOD05162003077519 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® Solution SIEMENS Generate QC Reports Healthineers Exporting QC Data SIEMENS Atellico Solution Version 1.14.0.2963002 SP00107 1 1. At the Command Bar, select QC System -Samples Inventory Patient Ondors Workbist Maintenance Scoop Create QC Orders Control Bracketing 2 QC Statistics Patient QC Flagging QC Definitions QC Panels Qc Scheduler 2. Select the QC Statistics tab Reftw Analy 3 Malebenarice 4 Export 3. Select the Tools tab Current time filter: ne tine filter applied Renove Time Fater 4. Select the Export tab Apply Tire FIbee Qc 5. Select the data to export, the time filter, and the file type Show by Control 9 Ten Expert Tez Severity 4 Level Lot rile Sue System 6. Select Export Ter AFP Control Move Down Restare Default Lettuded Range Flap viter Flags Oc viulation Select 6 ? LabManager Thursday, May 31, 2013 2:41 PM4 38 Effective Date: 06-APR-2020 | HOOD05162003077519 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® Solution SIEMENS Manage QC Lot Crossovers Healthineers Workflow for Managing QC Lot Crossovers 1. Create a definition for the new lot of QC, with the Usage set to Parallel 2. Create orders and process samples for the new QC lot, for a period of time determined by the laboratory’s Standard Operating Procedure 3. Review QC results and statistics 4. After a period of time determined by the laboratory’s Standard Operating Procedure, edit the new QC definition using the Observed Ranges feature. Set the Usage to Primary 5. Edit the QC definition for the old lot of QC to set the Usage to Not in Use 39 Effective Date: 06-APR-2020 | HOOD05162003077519 Unrestricted © Siemens Healthcare GmbH, 2020 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'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 may vary from country to country and is subject to varying regulatory requirements. Please contact your local representative for availability. Copyright © Siemens Healthcare GmbH 2020 Global Siemens Healthineers Headquarters Henkestr. 127 91052 Erlangen, Germany Phone: +49 9131 84 0 siemens.com/healthineers 40 Effective Date: 06-APR-2020 | HOOD05162003077519 Unrestricted © Siemens Healthcare GmbH, 2020