Atellica® Solution Lot & Pack Calibration Online Training Series: Understanding Lot & Pack Calibration (Course 1 of 2)

Continue Continue Continue Continue Continue Lot & Pack Master Template HILS2218 | Effective Date: 25-Mar-2022 Atellica® Solution Lot & Pack Calibration Online Training Series, Course 1 of 2: Understanding Lot & Pack Calibration In this course the foundational concepts of lot and pack calibration are discussed as well as tips to prevent error on your system. This is the first course in a two part series. Describe the difference between lot and pack calibration 1 Summarize effective tips to prevent lot and pack calibration error 4 Discuss routine system management of lot and pack calibration 3 2 Describe how to locate calibration intervals for an assay Welcome Welcome to the Atellica Solution, lot and pack calibration online training series. My name is Annette. I'm an Application Specialist for the Atellica Solution. Understanding Lot and Pack Calibration is the first course in a 2 part series. This content is important to effectively manage your system. At the completion of this online training, you will be able to describe how the Atellica Solution utilizes both lot and pack calibration intervals, discuss normal system management of lot and pack calibration and effective tips to prevent error. In course 2 we will discuss lot and pack calibration troubleshooting. Atellica® Solution uses: Two types of calibration: Lot & Pack Introducing Lot & Pack Calibration Lot Calibration Pack Calibration CH Wells Select the tab arrows to learn more C0 Adjust Job Aid is available in the Resources Tab and on PEPconnect One calibration adjustment technique: C0 Adjust Lot & Pack Calibration Throughout this course, we will discuss the two primary calibration types used by the Atellica Solution; lot and pack calibration. These calibrations are essential to managing reagents on board. The Atellica Solution also uses a calibration adjustment technique called C0-adjust which is available for select assays. Your system will automatically determine when a C0-adjust is warranted. Please refer to the C0-adjust job aid available in the resources tab of this course and on PEPconnect for additional information. Select the tab arrows on your screen to learn about lot and pack calibration as well as several important points associated with CH wells. Notes: Lot: Lot calibration is specific to a lot of reagent packs. This calibration interval will apply to all packs of the same lot of material and must be calibrated within 24 hrs of being loaded onto the system. The lot calibration will also apply to all subsequent packs of that same lot loaded later and will be valid until the initial lot calibration expires. In order for a calibration to qualify as a lot calibration, the calibration must be done within 24 hours after a new IM pack is loaded on the system or 24 hours after a CH well is pierced. This provides the user with the longest duration of reagent use. Notes: Pack: Pack calibration will apply to a specific pack of IM reagent or well of CH reagent, once it’s pierced, and does not apply to following packs of the same reagent. The benefit of pack calibration is that it allows for a pack to remain on board for a longer duration because the pack cal adjusts for onboard stability. A pack calibration maybe required before the lot calibration expires. Please note: if a new pack or well of reagent is not calibrated within 24 hours of load, it’s not eligible for a lot calibration and will be calibrated as a pack. Notes: CH wells: Let’s discuss CH reagents in more detail as these packs have two wells of product. For calibrations; each well is treated individually. When the material is initially loaded to the system the first well will be opened and inherits the existing lot calibration; if there is one established and it’s from the same lot of material. This process will also apply to the second well of reagent. When the second well is opened it’s treated like an individual pack and also inherits the initial lot calibration. When that well is due for a pack calibration, it will be performed on that individual well. Lot Calibration Select the X to return to the course Eligible for lot calibration: IM packs loaded within 24 hrs CH wells pierced within 24 hrs Applies to all following packs of the same lot until the lot calibration expires Starts when a reagent pack of a new lot is loaded Pack Calibration Applies to a specific pack of IM reagent or a specific well of CH reagent (once pierced) Does not apply to following packs of same reagent Allows for the pack to remain on board for a longer duration of time because it adjusts for the onboard stability Pack cal maybe required before the lot cal expires New packs/wells NOT calibrated within 24 hrs will be calibrated as a pack Not eligible for to be used for a lot calibration after 24 hrs Select the X to return to the course Select the X to return to the course CH Wells CH reagents have two wells of material; each is treated individually When the pack is loaded the 1st well will be opened and inherits the existing lot calibration; if there is one established When 2nd well is opened it will also inherit the lot calibration; similar to the first well When pack calibration is due it will be performed on the individual well Benefit Lot vs. Pack Calibration Improved stability QC results Reduces reagent waste Pack calibrations are good for low volume assays Fewer calibrations over reagent lot Saves money Lot calibrations are good for high volume assays Benefit Lot vs. Pack Calibration Lot calibrations benefit labs performing a large volume of tests on a particular assay. In this case, the system will use the entire content of the reagent before the pack calibration interval expires. Thus, all following packs or wells loaded from the same lot of material will not require calibration until the initial lot calibration expires. Overall, lot calibration allows fewer calibrations over the life a reagent lot, saving time and money for the lab. In contrast, when a lab is performing a lower volume of tests for an assay, they may not use the entire reagent pack or well before the pack calibration expires. In this case, re-calibration of the pack or well is required to continue use of that reagent. This is the benefit of a pack calibration. The individual pack calibration leads to more stable QC results and prevents waste of reagents. Calibration Intervals Select FT4 IFU Document Calibration Intervals The Siemens Document Library is an excellent resource for locating lot and pack calibration intervals. One resource that includes these intervals is the Instructions for Use (IFU) document which is available for each assay. The IFU document includes the most up to date detailed assay information. Another resource is module specific assay charts. These charts are a quick reference of pertinent information and can be helpful to have on hand in the lab. To find these references, navigate to the Siemens Document Library. Use the search filters to locate the IFU for your assay of interest. For example, we can find information on Free Thyroxine (thigh-raak-seen) (FT4) by searching Atellica Solution and selecting the IM analyzer. Then type Free Thyroxine (thigh-raak-seen) into the filter. Select the Free Thyroxine (thigh-raak-seen) IFU document on your screen. Notes: FT4 The lot calibration is the duration of time the lot calibration is valid for. From the document, we learn that the lot cal for FT4 is 21 days. The pack calibration is the amount of time a reagent can be used with the current calibration event before a pack cal is required. The pack cal for FT4 is 7 days. The other interval shown on this chart is the reagent onboard stability (OBS). This interval is the duration a reagent can remain on the system. Your Atellica system will track these intervals automatically. Pack Calibration: duration of time reagent can be used with current calibration event before a pack cal is required Onboard Stability (OBS): duration reagent can remain on the system Calibration Intervals Lot Calibration: duration of time the lot cal is valid for Select the X to return to the course Lot & Pack Calibration Example Day 14 Day 7 Day 21 Day 1 Calibration Example Let’s look at an example to further demonstrate when to use a lot vs. pack calibration. In this example we will use the intervals for free thyroxine (thigh-raak-seen), which are 7 days for a pack calibration and 21 days for a lot calibration. When we load pack 1 on day 1 the initial lot calibration is performed. By day 7, this pack will be due for a pack calibration, as the pack cal interval is 7 days. On day 14, pack 1 is empty and thus removed from the system. We load pack 2, from the same lot of material, and thus it inherits the initial lot calibration as we are still within the 21 day lot calibration interval. On day 21,pack 2 is empty and removed from the system. We load pack 3 which will need a new lot calibration because the initial lot cal expires at day 21. Let’s Practice with UN_c! Day 6 Day 1 What type of calibration should be performed on pack 2 when it’s loaded on day 6? Select the appropriate button. Calibration Practice Let’s practice using the blood urea nitrogen reagent on the CH analyzer. In this example we work in a busy lab that uses the Atellica system daily and strictly follows calibration schedule recommendations. Here are the stability intervals. Remember, this is a CH assay thus pack calibrations refer to one well of reagent. On day 1, we load UN_c reagent pack 1 and perform the initial lot cal. On day 6, pack 1 is due for a pack calibration as the pack cal interval is 6 days. We also note pack 1 is low and thus we load pack 2 from the same lot. What type of calibration should be performed for pack 2 when it’s loaded on day 6? Select the appropriate button. Pack 2 inherits the initial lot calibration because the lot cal interval has not expired. Pack 2 inherits the initial lot calibration because the lot cal interval has not expired. Let’s Practice with UN_c! Day 6 Day 12 Day 1 On day 12, what type of calibration should be performed on pack 2? Select the appropriate button. Calibration Practice We're now at day 12. Pack 1 is empty and thus removed from the system. What type of calibration should be performed on pack 2? Select the appropriate button. Pack 2 is due for a pack calibration as it has been 6 days (the pack cal interval). Pack 2 is due for a pack calibration as it has been 6 days (the pack cal interval). Routine System Management Select Calibration Due Tile Routine System Management The Atellica® Solution automatically manages reagent calibrations by using both lot and pack calibrations. Checking calibrations due from the main home screen on your system is part of your daily workflow. As you can see in this example, 5 calibrations are due. Please select the "calibrations due" tile to learn more about normal calibration management. Notes: Cal Due: The "Calibrations Due" screen shows orders that the system is planning to place for onboard reagents. Routine calibrations are typically associated with an expired pack or well calibration or a new lot is being loaded on to the system. Information on whether the type of calibration will be pack or lot is not displayed on this screen because the type of calibration is determined at the time the actual order is created. These details are shown on the calibration results screen which can be selected from the bottom of this screen. On the right side of this screen information is provided about reagents that will need a lot calibration when a new pack is loaded to the system. Action is not required for these assays at this time. To learn more about managing calibrations due, please go to PEPconnect and search for our Day in the Life Series. My colleague, Sam, hosts a training called “Checking Calibrations Due on the Atellica® Solution – A Comprehensive Overview” that provides additional detail. For more information on Calibration, please refer to the Day in the Life Series: “Checking Calibrations Due on the Atellica® Solution – A Comprehensive Overview” Available on PEPconnect - Sam NOTE: Routine calibrations are typically associated with: Expired reagent pack/well calibrations Loading a new lot Select the X to return to the course Tips to Maintain Calibration Calibrator Reagent Select the tab arrows to learn more Tips to Maintain Calibration As an application specialist, I have several tips that I would like to share with you to maintain the best calibrations on your Atellica Solution system. Proper care and attention to calibrator and reagents is the key! Please select each tab arrow to learn my favorite tips for calibrator and reagent management! Notes: Calibrator The three areas of focus for calibrator include preparation, management and storage. Proper preparation of the calibrator is essential. Calibrators are either lyophilized or liquid ready. Confirm what type of calibrator you're working with by looking in the vial. Some assays, such as, Troponin (trowponinn), include preparation of both a lyophilized calibrator and a ready to use liquid calibrator. Lyophilized calibrator requires the addition of liquid and time to fully reconstitute. Do not rush the reconstitution process as it will result in calibration error. Liquid ready calibrator does not need any additional preparation. Adding liquid to these vials will result in error. Be aware of calibrator expiration dates and open vial stability. If calibrator is used past the expiration date printed on the vial or if not used within the timeframe of open vial stability, errors will result in your data. Refer to IFU for open vial stability information. Finally, let’s discuss storage. If a tube of calibrator is not being stored in Cal/ QC storage, but is left onboard in the Sample Handler drawers once calibration is complete, it can negatively impact future calibrations. The next calibration order will attempt to use the old calibrator (if it's left onboard) and most likely produce a poor calibration event or fail QC, which will trigger an unnecessary calibration. Thus, remember to remove calibrator once used if it’s not being stored in Cal/ QC storage. Notes: Reagent Improper reagent preparation commonly leads to calibration error. Two areas of focus to be aware of include reagent exposures and additives for manual preparations. Improper exposure of the reagent to light and temperature will damage the material negatively impacting calibration. Please be cognizant of reagent exposures during preparation. As you know, some reagents require manual preparation, such as VB12 as shown here. If the reagent additive is not added some assays will not calibration while others will result in a shift in results. Please follow IFU instruction for additive preparations. Reagent Tips Must add additive to some reagents Ex: ALTPLc, VB12 DTT, Folate DTT Preparation: Manual Additives Light Temperature Preparation: Improper Exposure Preparation Improper Exposure Manual Additives Select the X to return to the course Calibrator Tips Preparation: Lyophilized: allow full time to reconstitute Determine if calibrator is lyophilized or liquid ready by looking in vial Liquid ready: do not add additional volume to the vial Management: Do NOT use past expiration date printed on vial or past timeframe of open vial stability (found in IFU) Storage: Remove calibrators not stored in Cal/QC Storage from SH when calibration is complete Old calibrator will negatively impact future calibrations Areas of focus: Preparation Management Storage Select the X to return to the course Course Review Congratulations! You have completed the Atellica® Solution Lot & Pack Calibration Online Training Series, Course 1 of 2: Understanding Lot & Pack Calibration. Select the numbered buttons below to review the content. Discuss routine system management of lot and pack calibration Describe how to locate calibration intervals for an assay Describe the difference between lot and pack calibration 1 1 1 3 3 3 2 2 2 4 4 4 Summarize effective tips to prevent lot and pack calibration error Course Review Congratulations! You have completed the Atellica® Solution Lot & Pack Calibration Online Training Series, Course 1 of 2: Understanding Lot & Pack Calibration . Select the numbered buttons below to review the content associated with each objective. Tips to Prevent Lot & Pack Calibration Error Table with 2 columns and 4 rows Calibrator Preparation: Liquid ready: do not add additional volume to the vial Lyophilized: allow full time to reconstitute Management: Do NOT use past expiration date printed on vial or past open vial stability Storage: Remove calibrator not stored in Cal/QC Storage Table with 2 columns and 3 rows Reagent Preparation- Exposure: Do not expose to light Do not expose to temperature Preparation- Manual ADD required additives Follow assay specific IFU prep instruction Select the X to return to the course Routine System Management Reagent calibrations managed using both lot calibrations and pack calibrations Check Calibration Due tile Shows orders that the system is planning to place Select the X to return to the course For more information on calibration refer to the Day in the Life Series: “Checking Calibrations Due on the Atellica® Solution – A Comprehensive Overview” – available on PEPconnect Lot vs. Pack Calibration Interval Lot Calibration Interval: duration the lot cal is valid for Pack Calibration Interval: duration the pack cal is valid for Find assay specific calibration intervals in the IFU information The Atellica® Solution software automatically track intervals Select the X to return to the course Lot vs. Pack Calibration Table with 1 columns and 5 rows Lot Calibration Applies to a LOT of reagent Must be calibrated within 24hrs of load Provides longest duration of reagent use Benefits high volume assays Table with 1 columns and 5 rows Pack Calibration Applies to INDIVIDUAL pack of reagent Improves QC results Reduces reagent waste Benefits low volume assays Select the X to return to the course Disclaimer 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. © Siemens Healthcare GmbH 2023 Siemens Healthineers Headquarters\Siemens Healthcare GmbH\Henkestr. 127\ 91052 Erlangen, Germany\Telephone: +49 9131 84-0\siemens-healthineers.com Disclaimer Assessment Start This assessment will test your retention of the presented content. A passing score of 80% or higher is required to complete the course and earn your certificate . Assessment questions must be answered completely to receive full credit. Partial credit will not be given for assessment questions that require multiple answers. You may repeat the assessment as many times as needed. Assessment Select the best answer. Reduces reagent waste Applies to all packs of the same lot Question 1 of 5 Which of the following is true of pack calibration? Benefits high volume assays Must be calibrated within 24 hours Multiple Choice Some calibrations types must be performed within 24 hours. Multiple packs are included in a lot of material. High volume assays are performed frequently. Select the best answer. Time interval that the lot calibration is active Interval when the reagent expires Question 2 of 5 What is the lot calibration interval for each assay? Time interval of onboard stability Interval when reagent must be removed from system Multiple Choice Reagents have an expiration date. Reagents have a limited duration of life on the system. All reagents have an onboard stability interval. Question 3 of 5 From the home screen, select the appropriate tile to check calibrations due, then select Submit below. Hotspot You did not select the correct tile. Select the best answer. Contain assay calibration intervals Contain assay expiration date Question 4 of 5 Which of the following is true regarding assay Instructions for Use (IFU) documents? Located on PEPconnect Located on Atellica® Solution software Multiple Choice The Atellica® Solution software runs the Atellica® solution products. Reagent expiration date is printed in the product labeling. IFUs are located in the Document Library. Select the best answer. Preparation, Management, Storage Management, Load, Disposal Question 5 of 5 What are three (3) areas that can impact calibration errors? Preparation, Storage, Disposal Management, Storage, Disposal Multiple Choice Disposal is the active of throwing away. Reagents are best stored in cal/control storage. Preparation includes time for reagents to reconstitute. Assessment Results YOUR SCORE: PASSING SCORE: Review Retry Retry Continue Continue Continue %Results.ScorePercent%% %Results.PassPercent%% Assessment Results You did not pass the course. Take time to review the assessment then select Retry to continue. Congratulations. You passed the course.. Exit To access your Certificate of Completion, select the Launch button drop down on the course overview page. You can also access the certificate from your PEPconnect transcript. You have completed the Atellica® Solution Lot & Pack Calibration Online Training Series, Course 1 of 2: Understanding Lot & Pack Calibration. Completion Question Bank 1 HOOD05162003355898 | Effective Date: 2 JUN 2023 Atellica® Solution C0 Adjust Pack Calibration Job Aid Atellica® Solution Lot & Pack Calibration Troubleshooting Job Aid 1.1 Welcome 1.2 Lot & Pack Calibration 1.3 Benefit Lot vs. Pack Calibration 1.4 Calibration Intervals 1.5 Calibration Example 1.6 Calibration Practice 1.8 Routine System Management 1.9 Tips to Maintain Calibration 1.10 Course Review 1.11 Disclaimer 1.12 Assessment