Atellica® Solution System Calibration FAQs Version 1.25 and Below

SIEMENS Healthineers . Atellica® Solution Siemens Healthcare Diagnostics Inc. Frequently Asked Questions (FAQs) System Calibration FAQs This purpose of this document is to address common questions customers may have regarding system calibration on the Atellica Solution. If you have any questions which are not included in this document please refer to the Operator’s Manual and/or contact your local Siemens Healthineers Customer Service. This document has 4 main sections: I. Basic Facts for Atellica Calibrations Pages 1-2 II. Tips for Successful Calibrations Pages 2-3 III. Flags Associated with Calibration Orders and Action Required Pages 4-5 IV. Abbreviations Page 6 I. Basic Facts for Atellica Calibrations A. Atellica IM 1300/1600 Analyzer employs 2-point calibrations; every lot of reagent has a test definition (Tdef) scanned into the analyzer before the new reagent lot is loaded onto the analyzer. The Tdef contains the master curve for that lot created at the manufacturing site. The 2-pt lot calibration (Cal A or Low and Cal B or High) calibrates the specific system and specific lot to the master curve. B. Atellica CH 930 Analyzer has several different calibration schemes; linear using 2- 3 calibrators and non-linear, using up to 6 calibrators. Note: CH reagents are divided into 2 wells and each well operates independently for the lot and pack calibration criteria. C. Calibration Types 1. Lot Calibrations a. Lot calibrations are only performed with a reagent which has been onboard the system <24 hours. b. Lot calibrations are used for all packs in the same reagent lot until the Calibration Lot Interval has been reached. Recalibration of the lot is then required. 2. Pack Calibrations a. Pack calibrations are used to maintain individual packs which have been onboard the system for an extended period of time. This period of time is called the pack calibration interval. b. The pack calibration is only valid for one specific reagent pack and is assay-specific. If multiple packs of the same lot are onboard, it is possible to have multiple calibrations in use. For example, pack with lot calibration, and a pack with a pack calibration. c. If the lot calibration expires, and the pack has been on the system >24 hours a lot calibration will be prevented from being performed. A pack calibration will allow continued use of that pack. Atellica Solution Calibration FAQs HOOD05162002953698 Effective Date 10/8/2018 Page 1 of 7 SIEMENS Healthineers . D. Atellica CH Specific Pack Calibrations 1. For select CH assays, the Pack calibration is done using the CH Diluent (saline) and is similar to a reagent blank, requiring no calibrator to be loaded. The assays are: Acetaminophen Triglycerides Cholesterol 2 Uric Acid Glucose Oxidase Urea Nitrogen Inorganic Phosphorus 2. This pack calibration is also known as the C0 Adjust. 3. The only time calibrators are used for a pack calibration for these assays is IF there is no lot calibration for the assay. Then the pack calibration will be a full calibration requiring calibrators. 4. For Amylase and PAmylase, CH Diluent (saline) is used for all calibrations and is a C0 adjust. No calibrator required. II. Tips/Guidelines for Successful Calibrations  Allow any calibration material not stored in the Atellica Sample Handler Cal/QC tube storage area to come to room temperature before loading onto the system.  Ensure the calibrator material is the correct active lot for the appropriate assay.  Ensure the barcode for the calibrator material is printed from the system performing the calibration.  If the calibrator material is stored in the Sample Handler Cal/QC tube storage area, ensure it has not expired for the assays requiring calibration.  Ensure all the correct materials are loaded including the appropriate QC if using the Perform QC with Calibration feature.  For the calibration type desired (lot or pack), verify the assay reagent pack is eligible in the Inventory Reagent Overview. Calibration Troubleshooting Questions: A. Why didn’t my Calibration Order start to process after placing the order? 1. The calibrator material vial barcode was printed from another Atellica Sample Handler. 2. Analyzer is in wrong state when calibration order was placed. Wait for Ready/Standby mode after analyzer maintenance or diagnostics. 3. Not enough material was loaded. a. QC or Cal material is missing, expired or the volume is insufficient. b. “Perform QC with Cal” is enabled for the assay and all of the QC materials are not onboard. 4. A previous calibration order has a problem and is blocking the new order. Resolve the problem with the previous order and the calibration will proceed. Atellica Solution Calibration FAQs HOOD05162002953698 Effective Date 10/8/2018 Page 2 of 7 SIEMENS Healthineers . 5. Calibrator lot loaded is not marked as “Active”. Go to calibration definition screen to verify active calibrator lot is checked as active 6. Assay for calibration order not enabled or the reagent is not onboard system. 7. Insufficient tests remaining in reagent pack. Lot calibration must have enough reagents to complete all necessary calibration aspiration replicates. Pack calibration must have enough to complete all replicates + 1 test. 8. Unable to order lot calibration because the pack is ineligible for lot calibration. Go to Reagent Overview to determine calibration type eligibility 9. Aspiration errors block calibration orders. Check samples for sufficient volume, or troubleshoot analyzer issue, and create calibration order again. 10. CH “C0 Adjust” calibration order does not process if no prior lot calibration performed for the appropriate lot. Perform lot (if eligible), or full pack calibration 11. The IM Analyzer rejects a calibration order for a control-bracketed assay when a control bracket is open with retained results or the analyzer is processing control-bracketed tests. Open bracketed assay must be closed before proceeding. 12. Other open calibration orders exist for the test, reagent lot, or calibrator lot. Wait until the open calibration order completes, and then place a new order. 13. Material required (Cal or QC) is onboard but has errors associated with it (expired, insufficient volume, recalled, cap / cup detect mismatch etc.). Correct material issue. 14. Calibrator / QC samples stuck on the track due to lack of empty slots in sample rack on the Atellica Sample Handler and this blocks further orders involving the same Calibrator / QC samples. Remove samples in racks to create empty slots. B. Why didn’t the system correctly process an Automatic Calibration (these are in addition to the items in A)? 1. No automatic calibration trigger selection was configured in the assay test definition. Go to system Setup, TDef and activate auto calibration triggers. 2. Restarting the main computer (PCC) causes loss of the trigger command to perform an automatic calibration. Recreate the Order. 3. Automatic calibration does not process due to expired status of calibration reagent lot. New lot must be defined and loaded. 4. Automatic calibration does not process for IM assays with control bracketing. See A, 11. 5. Another calibration order exists in ordered state for same assay and same pack on the same analyzer. An operator event is created that states the calibration order was not created because another order exists. Resolved by one of the following: Delete the existing order or wait for existing order to complete before creating new manual order. 6. CH only: When lot cal is about to expire and onboard packs are not eligible for lot calibration, introducing a new pack doesn’t generate lot calibration order right away. Existing packs first need to reach 15% available test counts or less for a lot calibration trigger to be generated. Atellica Solution Calibration FAQs HOOD05162002953698 Effective Date 10/8/2018 Page 3 of 7 SIEMENS Healthineers III. Flags Associated with Calibration Orders and Action Required A. Address the issue and re-create the order Flag created User action with Order Scenarios when flag is shown (Calibration must be reordered) Module 1. For QC / Patients, the Analyzer rejected 1. Analyzer has rejected work. Check event Unavailable work and re-planning attempts log for reason and address the issue. Place exhausted. order again after addressing issues. 2. When analyzer is not available for 2. Check analyzer state and ensure analyzer is planning the work. in standby / ready / processing state. Order will automatically be processed. Check Sample Tests could not be run because Sample Check SH state. Ensure SH covers are closed Handler State Handler (SH) is not available to load required and SH is in standby / ready / processing state. Calibration / QC material to Atellica Magline® If system is not automatically processing Transport. blocked tests, then delete the order and re- create the order. Analyzer Analyzer rejected work for Cals. Analyzer has rejected work. Check event log for Rejected reason as and address the issue. Place order again. System Error 1. Samples are waiting in DWQ for an Check analyzer, Atellica Magline Transport and extended time. SH states. Check operator event log for errors. 2. PCC is being shut down preventing Cal Address any identified issues and re-create the order from processing. order. Atellica Error when attempting to deliver tubes to Check operator log for Atellica Magline Magline Error INPUT queue. Transport errors. Address any identified issues and re-create the order. Sample Error Cal / QC order could not be processed since Check sample error from sample details screen. one or more required calibrator or QC Address any identified issues and re-create the material has errors associated. order. Manually Cal/QC is recalled from SH storage Remove recalled sample off the system and Cancelled compartment but not yet removed off the introduce new material through SH. Re-create system. the order. Sample Sample has been removed from the system. Load all the missing calibrator and QC material Unloaded needed for this order. Re-create the order. Atellica Solution Calibration FAQs HOOD05162002953698 Effective Date 10/8/2018 Page 4 of 7 SIEMENS Healthineers B. Address the issue and order will automatically process* *Order will not automatically process if Calibration is in the Invalid state. In this case it will need to be re-created. Flag created User action (Calibration will automatically with Order Scenarios when flag is shown process) Cal None Patient / QC tests could not be run because Calibrate the specific assay and analyzer. specific assay and lot is not calibrated on the Once calibration is valid, system will specific analyzer. automatically process the blocked QC / patient order(s). QC Error Tests could not be run because specific assay QC the specific assay on the specific analyzer. is out of QC on the specific analyzer. Once calibration is valid, system will automatically process the blocked QC / patient order(s). Patient Tests could not be run because patient Enable patient processing on the specific Processing processing has been disabled on specific analyzer. Once calibration is valid, system will Disabled analyzer. automatically process the blocked QC / patient order(s). No Primary Tests could not be run because the specific Add primary reagent packs and calibrate if assay is not having sufficient primary reagent needed. System will automatically process the to complete the test(s). blocked tests once there are sufficient tests onboard. Consumables Tests could not be run because one or more Ensure all needed consumables are onboard. required consumables needed to run the tests are not System will automatically process the blocked onboard or are not sufficient. tests once all needed consumables are onboard. Missing Module Test processing is blocked because the Check analyzer state screen and alerts / event Capability specific analyzer is missing one or more logs and ensure missing capabilities are required capability to process the test(s). restored. System will automatically process the blocked tests once all needed capabilities are restored. Reagent Prep in Test processing is blocked because specific No action needed from operator. System will Progress reagent is still being mixed. automatically process the blocked tests once reagent preparation is complete. Missing Lot Tests could not be run because the specific Ensure needed lot locked reagent is onboard Locked Reagent lot locked reagent is not onboard or is not and has sufficient test counts. System will having sufficient test counts. automatically process the blocked tests. No Ancillary Tests could not be run because needed Ensure ancillary is onboard and is sufficient. ancillary reagents are missing or there is not System will automatically process the blocked enough to process the tests. tests. No Diluent Tests could not be run because needed Ensure diluent is onboard and is sufficient diluent is missing or there is not enough to System will automatically process the blocked process the tests. tests. Check Atellica Tests could not be run because Atellica Check Atellica Magline Transport state. Ensure Magline State Magline Transport is not available to all Atellica Magline Transport covers are closed transport samples to specific analyzer. and it is in standby / ready / processing state. System will automatically process blocked tests. Atellica Solution Calibration FAQs HOOD05162002953698 Effective Date 10/8/2018 Page 5 of 7 SIEMENS Healthineers . Abbreviations Abbreviation Meaning Cal or Cals Calibrator or Calibration materials CH Analyzer Atellica CH Analyzer (clinical chemistry) DWQ Designated Waiting Queue IM Analyzer Atellica IM Analyzer (immunoassay) PCC Process Center Computer (main computer) QC Quality Control SH Atellica Sample Handler Atellica Solution Calibration FAQs HOOD05162002953698 Effective Date 10/8/2018 Page 6 of 7 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 varies by country and is subject to varying regulatory requirements. Please contact your local representative for availability. Copyright © Siemens Healthcare GmbH 2018 ………………………………………………………… Siemens Healthineers Headquarters Siemens Healthcare GmbH Henkestr. 127 91052 Erlangen, Germany Telephone: +49 9131 84-0 siemens.com/healthineers Atellica Solution Calibration FAQs HOOD05162002953698 Effective Date 10/8/2018 Page 7 of 7